tec5500 om e

0614-008784E

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DefibrillatorTEC-5521/TEC-5531

TEC-5500 seriesTEC-5521BTEC-5521ETEC-5521KTEC-5531BTEC-5531ETEC-5531K

Trademark

The mark printed on the holter card and SD card adapter that are used in this instrument is a trademark. The company

name and model name are trademarks and registered trademarks of each company.

CONTENTS

Operator's Manual TEC-5500 C.1

ContentsGENERAL HANDLING PRECAUTIONS ................................................................................... i

WARRANTY POLICY .............................................................................................................. ii

EMC RELATED CAUTION ...................................................................................................... iii

Conventions Used in this Manual and Instrument ...................................................................v

Warnings, Cautions and Notes ......................................................................................v

Explanations of the Symbols in this Manual and Instrument ........................................ vi

Section 1 General .................................................................................. 1C.1Introduction ..........................................................................................................................1.1

Models and Functions ................................................................................................1.1

Features .....................................................................................................................1.2

Composition .........................................................................................................................1.3

Caution Label and Caution Mark ...........................................................................................1.4

Panel Description .................................................................................................................1.5

Front Panel .................................................................................................................1.5

Top Panel (only for TEC-5531) ....................................................................................1.6

External Paddles ........................................................................................................1.7

Left Side Panel ...........................................................................................................1.7

Rear Panel .................................................................................................................1.8

Important Safety Information .................................................................................................1.9

Recording Sound ................................................................................................................ 1.27

Section 2 Preparation ........................................................................... 2C.1Location ................................................................................................................................2.1

Power ...................................................................................................................................2.2

AC Operation .............................................................................................................2.2

Battery Operation .......................................................................................................2.2

Using AC Power ...................................................................................................................2.3

Connecting the Power Cord ........................................................................................2.3

Using the Battery .................................................................................................................2.4

Safety Information about Battery Pack .......................................................................2.4

Checking the Battery Pack ..............................................................................2.6

Storage ............................................................................................................2.6

Disposal ...........................................................................................................2.6

Inserting the Battery into the Defibrillator ...................................................................2.7

Charging the Battery Pack .........................................................................................2.8

Trickle Charging ..........................................................................................................2.9

Remaining Battery Power Display ............................................................................ 2.10

Loading the Recording Paper .............................................................................................. 2.11

Basic Checks ..................................................................................................................... 2.12

Displaying the Basic Checks Screen ....................................................................... 2.12

Check Procedure ...................................................................................................... 2.12

Check Before Use .............................................................................................................. 2.15

CONTENTS

C.2 Operator's Manual TEC-5500

Before Turning On the Power .................................................................................... 2.15

Check Items After Turning the Power On .................................................................. 2.15

Section 3 System Setup Screen and Setup Screen.......................... 3C.1System Setup Screen ..........................................................................................................3.2

How to Change the Items on the System Setup Screen ............................................3.2

Configuration ..............................................................................................................3.3

Setting List .......................................................................................................3.4

Setting Description ...........................................................................................3.6

Battery Test .............................................................................................................. 3.12

HV Capacitor Test .................................................................................................... 3.12

Recorder Check ....................................................................................................... 3.12

System Information .................................................................................................. 3.12

Report History .......................................................................................................... 3.12

Use Voice File .......................................................................................................... 3.13

Setup Screen ..................................................................................................................... 3.14

Setup Item List ........................................................................................................ 3.14

How to Change the Settings on the Setup Screen ................................................... 3.15

Paddle Setup ............................................................................................................ 3.16

ECG Setup ............................................................................................................... 3.16

SpO2 Setup .............................................................................................................. 3.16

CO2 Setup ................................................................................................................ 3.16

Report Setup ............................................................................................................ 3.16

Recorder Setup ........................................................................................................ 3.16

Date/Screen ............................................................................................................. 3.16

Date and Time ................................................................................................ 3.16

2nd Wave ....................................................................................................... 3.17

QRS Setup ............................................................................................................... 3.17

Alarm Setup ............................................................................................................. 3.17

Save Report ............................................................................................................. 3.18

Section 4 Defibrillation, Synchronized Cardioversion and AED ..... 4C.1General

About Defibrillation, Synchronized Cardioversion and AED ...............................................4.0.1

Skin-Paddle Contact Impedance ....................................................................................... 4.0.2

Using the Pediatric Electrode Plate ...................................................................................4.0.3

Changing Paddle Settings ..................................................................................................4.0.4

Turning Synchronized Cardioversion With PADDLE Lead On/Off .............................4.0.4

Turning Heart Rate Alarm with PADDLE Lead On/Off .............................................. 4.0.5

Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for

Synchronized Cardioversion .............................................................................................. 4.0.6

ECG Input from Another Monitor .............................................................................4.0.6

ECG Input from External Paddles, Internal Paddles and Disposable Pads ..............4.0.8

Defibrillation

Defibrillation Screen .......................................................................................................... 4.1.1

Defibrillation with External Paddles .................................................................................... 4.1.2

CONTENTS


Important Safety Information .................................................................................... 4.1.2

Procedure................................................................................................................ 4.1.3

Defibrillation with Disposable Pads .................................................................................... 4.1.8

Important Safety Information .................................................................................. 4.1.8

Procedure................................................................................................................ 4.1.9

Defibrillation with Internal Paddles ................................................................................... 4.1.15

Important Safety Information ................................................................................ 4.1.15

Procedure.............................................................................................................. 4.1.16

Synchronized Cardioversion

Synchronized Cardioversion Screen .................................................................................. 4.2.1

Synchronized Cardioversion with External Paddles ...........................................................4.2.2

Important Safety Information .................................................................................. 4.2.2

Procedure................................................................................................................ 4.2.3

Synchronized Cardioversion with Disposable Pads ...........................................................4.2.9

Important Safety Information .................................................................................... 4.2.9

Procedure.............................................................................................................. 4.2.11

Synchronized Cardioversion with Internal Paddles ........................................................... 4.2.17


Procedure.............................................................................................................. 4.2.18

AED

AED Screen ...................................................................................................................... 4.3.1

Important Safety Information ............................................................................................4.3.2

AED Flowchart .................................................................................................................. 4.3.4

Preparation for AED Mode ....................................................................................... 4.3.5

AED Procedure .................................................................................................................4.3.6

When Nonshockable Rhythm Is Detected In AED Analysis .................................. 4.3.15

Section 5 Pacing.................................................................................... 5C.1About Pacing ........................................................................................................................5.1

Important Safety Information ...............................................................................................5.2

Pacing in Fixed Mode ...........................................................................................................5.3

Information on the Pacing Screen in Fixed Mode .......................................................5.3

Procedure...................................................................................................................5.4

Pacing in DEMAND mode .................................................................................................. 5.11

Information on the Pacing Screen in DEMAND Mode ............................................... 5.11

Procedure................................................................................................................. 5.12

Section 6 Monitoring ............................................................................. 6C.1General .............................................................................................................................. 6.0.1

Displaying the Monitoring Screen ............................................................................ 6.0.1

Screen Examples .................................................................................................... 6.0.1

ECG Monitoring

Preparing for ECG Monitoring ............................................................................................6.1.2

Preparation Flowchart ............................................................................................. 6.1.2

CONTENTS


Selecting a Lead .....................................................................................................6.1.2

Number of Electrodes and Measuring Leads ...........................................................6.1.3

Electrode Position ................................................................................................... 6.1.3

3 Electrode Leads .........................................................................................6.1.3

5 Electrode Leads .........................................................................................6.1.4

Selecting Electrodes and Lead ................................................................................6.1.5

Types of Electrodes and Lead .......................................................................6.1.5

Connecting the ECG Connection Cable or the JC-762V/JC763V Connection Cable to

the Defibrillator ........................................................................................................6.1.6

Connecting the ECG Connection Cable to the Defibrillator ............................ 6.1.6

Connecting the JC-762V/JC763V Connection Cable to the Defibrillator ........6.1.6

Attaching Disposable ECG Electrodes to the Patient .............................................. 6.1.7

Monitoring ECG with Disposable Pads ....................................................................6.1.8

Monitoring ECG .................................................................................................................6.1.9

ECG Information on the Monitoring Screen ............................................................. 6.1.9

Selecting an ECG Lead ................................................................................................... 6.1.10

Selecting ECG Sensitivity ............................................................................................... 6.1.11

AUTO .......................................................................................................... 6.1.11

Changing ECG Settings .................................................................................................. 6.1.12

Changing Settings on the ECG Setup Screen ....................................................... 6.1.12

Turning the AC Hum Filter On/Off .......................................................................... 6.1.13

Changing the Time Constant Setting ..................................................................... 6.1.14

Turning Pacing Pulse Rejection On/Off .................................................................. 6.1.15

Changing Heart Rate Upper/Lower Limit ................................................................ 6.1.16

Changing Settings on the QRS Setup Screen ....................................................... 6.1.17

Changing QRS Sync Sound Volume...................................................................... 6.1.18

Changing QRS Sync Sound Source ...................................................................... 6.1.18

Turning the VF/VT Alarm On or Off ....................................................................... 6.1.19

Use with an Electrosurgical Unit ...................................................................................... 6.1.20

SpO2 monitoring

General ..............................................................................................................................6.2.1

Preparing for SpO2 Monitoring ............................................................................................6.2.3

Preparation Flowchart .............................................................................................. 6.2.3

Selecting a Probe .................................................................................................... 6.2.3

Reusable Probes ........................................................................................... 6.2.4

Disposable Probes ........................................................................................ 6.2.5

Attaching the Probe to the Patient ..........................................................................6.2.6

Connecting Probe to Defibrillator .............................................................................6.2.6

Monitoring SpO2

..................................................................................................................................................................................................... 6.2.8

SpO2 Information on the Monitoring Screen ............................................................. 6.2.8

Changing SpO2 Settings .................................................................................................... 6.2.9

Changing Settings on the SpO2 Setup Screen......................................................... 6.2.9

Changing the Pulse Waveform Sensitivity .............................................................. 6.2.10

Selecting Sync Sound Pitch ................................................................................. 6.2.11

Changing the Pulse Rate Alarm Limits ................................................................. 6.2.12

Changing the SpO2 Alarm Limits ........................................................................... 6.2.13

Changing QRS Sync Sound Volume ..................................................................... 6.2.13

Changing QRS Sync Sound Source ...................................................................... 6.2.13

CONTENTS


CO2 monitoring

General .............................................................................................................................. 6.3.1

CO2 Sensor Kit ........................................................................................................6.3.3

Preparing for CO2 Monitoring ............................................................................................. 6.3.6

Preparation Flowchart .............................................................................................. 6.3.6

Connecting the CO2 Sensor Kit to the Defibrillator ................................................... 6.3.6

Monitoring CO2

........................................................................................................................................................................................................ 6.3.7

CO2 Information on the Monitoring Screen ............................................................... 6.3.7

Changing CO2 Settings...................................................................................................... 6.3.8

Changing Settings on the CO2 Setup Screen .......................................................... 6.3.8

Changing the CO2 Scale .......................................................................................... 6.3.9

Changing the etCO2 Alarm Limits .......................................................................... 6.3.10

Changing the Respiration Rate Alarm Limits ......................................................... 6.3.11

Changing the APNEA Alarm Limit .......................................................................... 6.3.12

Inspection of Measuring Accuracy ................................................................................... 6.3.13

Daily Inspection of Measuring Accuracy ................................................................ 6.3.13

Inspection of Measuring Accuracy (Precise Method) ............................................. 6.3.13

Checking Procedure .................................................................................... 6.3.14

Section 7 Alarm Function ..................................................................... 7C.1General .................................................................................................................................7.1

Alarm Types ...............................................................................................................7.1

Alarm Indication .........................................................................................................7.1

Alarm List ...................................................................................................................7.2

Alarm Status Marks and Messages ...........................................................................7.4

Temporarily Silencing an Alarm After It Occurs ....................................................................7.5

Silencing Alarms ........................................................................................................7.5

Resuming Alarms .......................................................................................................7.5

Suspending an Alarm Before It Occurs ................................................................................7.6

Suspending Alarms ....................................................................................................7.6

Automatic Alarm Recording ..................................................................................................7.6

Setting Alarms .....................................................................................................................7.7

Alarm Setting Range ..................................................................................................7.7

Setting Alarm Settings on the Alarm Setup Screen....................................................7.8

Setting Alarm Settings on the Alarm Setup Screen of the Setup Screen ...................7.9

Setting Alarms Individually ....................................................................................... 7.10

Section 8 Recording ............................................................................. 8C.1About Recording ...................................................................................................................8.1

Changing Report and Recorder Settings ...............................................................................8.3

Manual Recording .................................................................................................................8.4

Real Time or Delayed Waveform Recording ................................................................8.4

Procedure ........................................................................................................8.4

Report Recording .......................................................................................................8.5

Periodic List Report Recording .........................................................................8.5

Alarm Report Recording ...................................................................................8.5

Event List Report Recording ............................................................................8.6

CONTENTS


Defibrillation Report Recording .........................................................................8.8

VF Analysis Report Recording .........................................................................8.9

Trend Report Recording .................................................................................. 8.10

Event Recording ....................................................................................................... 8.11

Saving the Administered Medication ........................................................................ 8.12

Automatic Recording .......................................................................................................... 8.13

Record On Charging After Discharge........................................................................ 8.13

Alarm Recording ....................................................................................................... 8.14

Periodic Recording ................................................................................................... 8.15

Printed Letters and Marks .................................................................................................. 8.16

Section 9 Messages and Troubleshooting ......................................... 9C.1Messages .............................................................................................................................9.2

Troubleshooting .................................................................................................................. 9.10

General ..................................................................................................................... 9.10

Defibrillation .............................................................................................................. 9.11

Pacing (TEC-5531 Series Only) ................................................................................ 9.11

Monitoring ................................................................................................................ 9.12

ECG ............................................................................................................... 9.12

SpO2

................................................................................................................................................................................................. 9.13

CO2

..................................................................................................................................................................................................... 9.14

Recording ................................................................................................................. 9.15

Battery ..................................................................................................................... 9.16

SD Card ................................................................................................................... 9.16

Section 10 Maintenance ....................................................................... 10C.1Cleaning, Disinfecting and Sterilization .............................................................................. 10.1

Defibrillator ............................................................................................................... 10.1

External Paddles ...................................................................................................... 10.1

Internal Paddles ....................................................................................................... 10.2

Battery ..................................................................................................................... 10.2

ECG Electrode Leads and ECG Connection Cable .................................................. 10.3

Disposal and Replacement ................................................................................................. 10.4

Battery ..................................................................................................................... 10.4

Disposal of Battery Pack ................................................................................ 10.4

Replacing Battery Pack .................................................................................. 10.4

Disposable Pads ...................................................................................................... 10.6

Lifetime .......................................................................................................... 10.6

Disposal ......................................................................................................... 10.6

ECG ......................................................................................................................... 10.6

Electrode Lifetime .......................................................................................... 10.6

Disposing of Electrodes ................................................................................. 10.6

Check After Use ................................................................................................................. 10.7

Periodical Checks ............................................................................................................... 10.8

Checking External Paddles ...................................................................................... 10.8

Checking 270 J Energy Charge and Disarm ............................................................. 10.9

Battery Test ............................................................................................................ 10.10

CONTENTS


Checking the Battery Appearance .......................................................................... 10.12

HV Capacitor Test .................................................................................................. 10.13

Recorder Test ......................................................................................................... 10.14

Date and Time Adjustment ..................................................................................... 10.14

Periodical Replacement Schedule .................................................................................... 10.14

Repair Parts Availability Policy ......................................................................................... 10.14

Storage ............................................................................................................................. 10.15

Defibrillator and Battery .......................................................................................... 10.15

Short Term Storage (Ready for Use at Any Time) ........................................ 10.15

Long Term Storage ....................................................................................... 10.15

Disposable Pads and ECG Electrodes ................................................................... 10.16

Section 11 Reference ............................................................................ 11C.1Specifications .................................................................................................................... 11.1

Defibrillator ..................................................................................................... 11.1

Noninvasive Pacing (TEC-5531 series only) .................................................. 11.3

External Paddle (ND-552VB/VE/VK) .............................................................. 11.3

Battery ........................................................................................................... 11.3

Clock Accuracy .............................................................................................. 11.3

Environment ................................................................................................... 11.3

Safety ............................................................................................................ 11.4

Monitor ........................................................................................................... 11.4

ECG Amplifier ................................................................................................ 11.4

Recorder ......................................................................................................... 11.5

Rhythm Recognition Detector ........................................................................ 11.5

Power Requirements ...................................................................................... 11.5

Dimensions and Weight .................................................................................. 11.5

Electromagnetic Compatibility ........................................................................ 11.6

Reference ......................................................................................................................... 11.10

Standard Accessories ...................................................................................................... 11.11

Options/Consumables ...................................................................................................... 11.12

Pin Assignment ................................................................................................................ 11.14

AUX Connector of the QI-553V DSI/AUX OUT Interface Unit ................................. 11.14

General Requirements for Connecting Medical Electrical System .................................... 11.15

CONTENTS


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Operator's Manual TEC-5500 i

GENERAL HANDLING PRECAUTIONS

This device is intended for use only by qualified medical personnel.Use only Nihon Kohden approved products with this device. Use of non-approved products or ina non-approved manner may affect the performance specifications of the device. This includes,but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, inputboxes and AC power.

Please read these precautions thoroughly before attempting to operate the instrument.

1. To safely and effectively use the instrument, its operation must be fully understood.

2. When installing or storing the instrument, take the following precautions:

(1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly

ventilated areas, and dust, saline or sulphuric air.

(2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport.

(3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage.

(4) The power line source to be applied to the instrument must correspond in frequency and voltage to product

specifications, and have sufficient current capacity.

(5) Choose a room where a proper grounding facility is available.

3. Before Operation

(1) Check that the instrument is in perfect operating order.

(2) Check that the instrument is grounded properly.

(3) Check that all cords are connected properly.

(4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other

problems.

(5) All circuitry used for direct patient connection must be doubly checked.

(6) Check that battery level is acceptable and battery condition is good when using battery-operated models.

4. During Operation

(1) Both the instrument and the patient must receive continual, careful attention.

(2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety.

(3) Avoid direct contact between the instrument housing and the patient.

5. To Shutdown After Use

(1) Turn power off with all controls returned to their original positions.

(2) Remove the cords gently; do not use force to remove them.

(3) Clean the instrument together with all accessories for their next use.

6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is

not functioning properly, it should be clearly marked to prevent use while it is out of order.

7. The instrument must not be altered or modified in any way.

8. Maintenance and Inspection

(1) The instrument and parts must undergo regular maintenance inspection at least every 6 months.

(2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect

operating condition.

ii Operator's Manual TEC-5500

(3) Technical information such as parts list, descriptions, calibration instructions or other information is available for

qualified user technical personnel upon request from your Nihon Kohden distributor.

9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or

location of electrodes and/or transducers to avoid possible burn to the patient.

WARRANTY POLICYNihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year

from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from

the warranty.

NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period,

provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals.

No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other

warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by

someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty.

Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure.

Shipping costs must be pre-paid.

This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon

Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism,

water or other casualty, improper installation or application, or on which the original identification marks have been

removed.

In the USA and Canada other warranty policies may apply.

CAUTIONUnited States law restricts this device to sale by or on the order of a physician.

Operator's Manual TEC-5500 iii

EMC RELATED CAUTIONThis equipment and/or system complies with IEC 60601-1-2 International Standard for electromagnetic

compatibility for medical electrical equipment and/or system. However, an electromagnetic environment

that exceeds the limits or levels stipulated in IEC 60601-1-2, can cause harmful interference to the

equipment and/or system or cause the equipment and/or system to fail to perform its intended function

or degrade its intended performance. Therefore, during the operation of the equipment and/or system, if

there is any undesired deviation from its intended operational performance, you must avoid, identify and

resolve the adverse electromagnetic effect before continuing to use the equipment and/or system.

The following describes some common interference sources and remedial actions:

1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or

cellular phone:

Install the equipment and/or system at another location. Keep the emitter source such as cellular phone

away from the equipment and/or system, or turn off the cellular phone.

2. Radio-frequency interference from other equipment through the AC power supply of the equipment and/

or system:

Identify the cause of this interference and if possible remove this interference source. If this is not

possible, use a different power supply.

3. Effect of direct or indirect electrostatic discharge:

Make sure all users and patients in contact with the equipment and/or system are free from direct or

indirect electrostatic energy before using it. A humid room can help lessen this problem.

4. Electromagnetic interference with any radio wave receiver such as radio or television:

If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or

system as far as possible from the radio wave receiver.

5. Interference of lightning

When lightning occurs near the location where the equipment and/or system is installed, it may induce

an excessive voltage in the equipment and/or system. In such a case, disconnect the AC power cord

from the equipment and/or system and operate the equipment and/or system by battery power, or use an

uninterruptible power supply.

6. Use with other equipment

When the equipment and/or system is adjacent to or stacked with other equipment, the equipment and/

or system may affect the other equipment. Before use, check that the equipment and/or system operates

normally with the other equipment.

7. Use of unspecified accessory, transducer and/or cable

When an unspecified accessory, transducer and/or cable is connected to this equipment and/or system,

it may cause increased electromagnetic emission or decreased electromagnetic immunity. The specified

configuration of this equipment and/or system complies with the electromagnetic requirements with the

specified configuration. Only use this equipment and/or system with the specified configuration.

iv Operator's Manual TEC-5500

Caution - continued

8. Use of unspecified configuration

When the equipment and/or system is used with the unspecified system configuration different than the

configuration of EMC testing, it may cause increased electromagnetic emission or decreased

electromagnetic immunity. Only use this equipment and/or system with the specified configuration.

9. Measurement with excessive sensitivity

The equipment and/or system is designed to measure bioelectrical signals with a specified sensitivity. If

the equipment and/or system is used with excessive sensitivity, artifact may appear by electromagnetic

interference and this may cause mis-diagnosis. When unexpected artifact appears, inspect the

surrounding electromagnetic conditions and remove this artifact source.

If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden distributor or

representative for additional suggestions.

For EMC compliance, refer to “Specification - Electromagnetic Compatibility” in the Reference section

The CE mark is a protected conformity mark of the European Community. The products herewith comply with the

requirements of the Medical Device Directive 93/42/EEC.

NOTE about Waste Electrical and Electronic Equipment (WEEE) directive 2002/96/EEC

For the member states of the European Union only:

The purpose of WEEE directive 2002/96/EEC is, as a first priority, the prevention of waste electrical and

electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such

wastes so as to reduce the disposal of waste.

Contact your Nihon Kohden representative for disposal at the end of its working life.

Operator's Manual TEC-5500 v

Conventions Used in this Manual and Instrument

Dangers, Warnings, Cautions and Notes

Dangers, Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.

DANGERA danger is used to alert the user to a hazardous situation which will cause death or serious injury.

WARNINGA warning alerts the user to the possible injury or death associated with the use or misuse of the

instrument.

CAUTIONA caution alerts the user to possible injury or problems with the instrument associated with its use or

misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other

property.

NOTEA note provides specific information, in the form of recommendations, prerequirements, alternative

methods or supplemental information.

vi Operator's Manual TEC-5500

Explanations of the Symbols in this Manual and InstrumentThe following symbols found in this manual/instrument bear the respective descriptions as given.

On main unit

IPX1

IPX7

IPX4

Symbol Description Symbol Description

AC power operation Output

Charging Input

Charged (Battery charging is finished) Dangerous voltage

ECG lead ECG

ECG sensitivity Pacing start

Alarm off Pacing stop

Real time/delayed recording Attention, consult operator’s manual

Event recording Provides ActiBiphasic waveform defibrillation function

Inserting or removing the memory card Complies with IEC 60529 IPX1

Defibrillation-proof type BF applied part Complies with IEC 60529 IPX4

Defibrillation-proof type CF applied part Complies with IEC 60529 IPX7

The CE mark is a protected conformity mark of European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC.

The products marked with this symbol apply to the European WEEE directive 2002/96/EEC and require separate waste collection. For Nihon Kohden product labeled with this symbol, contact your Nihon Kohden representative for disposal at the end of its working life.

Operator's Manual TEC-5500 vii

On LCD

1 3

0

Symbol Description Symbol Description

Battery fully charged Add Z-fold recording paper

More than 2/3 battery charge remains QRS sync mark

More than 1/3 battery charge remains The point of implanted pacemaker

pulse output

Battery power for one 270 J charging remains AC power operation

Battery operation not available Alarm off

Real time/delayed recording Event recording

SD card inserted Cannot write to the SD card

Writing to the SD card Can eject SD card

ECG cascaded display Report recording

AED analysis paused SpO2 pulse wave unstable

CPR start VF/VT alarm off

viii Operator's Manual TEC-5500


Operator's Manual TEC-5500 1C.1

Section 1 General

Introduction .........................................................................................................................1.1

Models and Functions ...............................................................................................1.1

Features ....................................................................................................................1.2

Composition ........................................................................................................................1.3

Caution Label and Caution Mark ..........................................................................................1.4

Panel Description ................................................................................................................1.5

Front Panel ................................................................................................................1.5

Top Panel (only for TEC-5531) ...................................................................................1.6

External Paddles .......................................................................................................1.7

Left Side Panel ..........................................................................................................1.7

Rear Panel ................................................................................................................1.8

Important Safety Information ..............................................................................................1.9

Recording Sound ............................................................................................................... 1.27

1C.2 Operator's Manual TEC-5500


1. GENERAL

Operator's Manual TEC-5500 1.1

Introduction

Models and Functions

This instrument is a portable defibrillator with functions necessary for

cardiopulmonary resuscitation treatment by biphasic defibrillation waveform. In

AED mode, if the defibrillator detects a shockable rhythm in ECG analysis, it

automatically charges energy to prepare for defibrillation (AED function). This

helps doctors who are inexperienced in defibrillation to perform defibrillation

easily. This defibrillator can use either AC power operation or optional battery

operation according to where it is used. With an optional DSI interface unit or

DSI/AUX OUT interface unit, SpO2 and CO2 monitoring are available with this

defibrillator, which enables continuous monitoring of the patient after defibrillation

or cardioversion.

Functions TEC-5521 TEC-5531

External paddles Standard Standard

Internal paddles Option Option

Disposable pads Option Option

Defibrillation and synchronized cardioversion

Pediatric electrode assy 44 mm φ Option Option

3 lead ECG Standard Standard

AED function Standard Standard

Noninvasive pacing Not available Standard

SpO2 measurement Option Option

CO2 measurement Option Option

Voice prompt Standard Standard

5 lead ECG Option Option

External ECG input Option Option

External ECG output Option Option

SD card slot Standard Standard

Sound recording Standard Standard

1. GENERAL

1.2 Operator's Manual TEC-5500

1. Biphasic waveform defibrillation

The defibrillator provides biphasic waveform defibrillation. Biphasic

waveform defibrillation requires low energy than conventional monophasic

defibrillation.

2. Display

The display is 5.7 inch color LCD. ECG waveforms and messages are easy to

see. You can select either 25 or 50 mm/sec for sweep speed.

3. Selectable power sources, AC/ Battery

Either AC or battery power can be selected according to where it is used.

4. Fast charging

Charges from 0 to 270 J within 5 seconds in both AC and battery operation

(with a fully charged new battery at 20°C). Charges from 0 to 200 J within 3

seconds in both AC and battery operation. This enables timely defibrillation

and cardioversion.

5. Quick ECG waveform recovery

After defibrillation or cardioversion the ECG waveform returns within 3

seconds so you can immediately check the result of defibrillation or

cardioversion.

6. AED function

During ECG analysis, if the defibrillator detects a shockable rhythm, it

automatically charges energy to prepare for the next defibrillation.

7. Noninvasive pacing (only for TEC-5531 series defibrillator)

The TEC-5531 series defibrillator has noninvasive pacing. This is useful for

first aid for bradycardia that often appears after defibrillation.

8. SpO2 and CO2 monitoring

With the optional DSI interface unit or DSI/AUX OUT interface unit, SpO2 and

CO2 can be monitored on the defibrillator.

9. Voice prompt

This function is mainly used in AED mode. Defibrillator status and cautions

during defibrillation are directed by voice.

10. Basic function check

The defibrillator has a semi-automatic self check function for discharge,

battery, recording, alarm sound and voice. These checks are performed on one

screen. You can easily check the defibrillator before use.

13. SD card

With a specified SD card, report data and surrounding sound together with the

ECG waveforms can be recorded and transferred to a personal computer.

Features

1. GENERAL


Composition

TEC-5500 Series Defibrillator

Disposable pads P-510 Internal paddles

Standard accessories

Options

Cart KD-028ACart tray assembly DI-001A

SpO2 adapter JL-951T3 CO2 sensor kit TG-901T3

OPER/ALARM

CO2 ADAPTER

JG-901T3 CO2 adapter

TG-101T CO2 sensor

HOPER/ALARM

CO2 ADAPTER

TG-121T CO2 sensor


CO2 sensor kit TG-921T3

Name Qíty Recording paper (Z-fold) 1 Contact gel GELAID 1 Battery check label (for defibrillator) 1

Name TEC accessory set (100V/IEC) BC-763V ECG connection cable (IEC, 3 leads) + Power cord H

TEC accessory set (200V/IEC) BC-763V ECG connection cable (IEC, 3 leads) + Power cord N

TEC accessory set (100V/AHA) BC-763VA ECG connection cable (AHA, 3 leads) + Power cord H

TEC accessory set (200/AHA) BC-763VA ECG connection cable (AHA, 3 leads) + Power cord N

QI-552V DSI interface unit

QI-553V DSI/AUXOUT interface unit

1. GENERAL


Caution Label and Caution Mark

This indicates cautions labels, caution marks on the instrument and where the

related explanations are.

WARNINGConnect only the specified instrument to the defibrillator and follow

the specified procedure. Failure to follow this warning may result in

electrical shock or injury to the patient and operator, and cause fire or

instrument malfunction.

Refer to Section 5 “Pacing”

Refer to Section 4 “Defibrillation, SynchronizedCardioversion and AED”, “ECG Monitoring” in Section6 “Monitoring” and Section 9 “Messages andTroubleshooting”

Left side panel:Refer to “Using the Battery” and“Loading the Recording Paper” inSection 2 “Preparation”.

Refer to “ECG Monitoring”in Section 6.

Refer to “SpO2 Monitoring” and “CO2 Monitoring”in Section 6 .

Refer to Section 4 “Defibrillation,Synchronized Cardioversion and AED”

1. GENERAL


12

4

5

7

Panel Description

Front Panel

* When DSI/AUXOUT interfaceunit is connected 10

1

8

9 11

* When DSI interface unit is connected

6

3

No. Name Description

1 LCD display Displays monitored waveforms, alarm settings and other settings.

2 Energy/Mode Select control

Turns the power on/off or selects MONITOR mode, FIXED pacing mode*, DEMAND pacing mode* and defibrillation/cardioversion discharge energy. The control positions are OFF, MONITOR, AED, DISARM, 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, 270 joules, DEMAND*, FIXED*, BASIC CHECK and SETUP. To discharge the charged energy internally, turn to the DISARM position. * Pacing is only available for TEC-5531 series defibrillator.

3 Microphone Records the surrounding sound in an SD card. When the SD card is inserted into the defibrillator, recording automatically starts. To stop recording, select the Setup screen, then eject the SD card.

4 SYNC button/lamp Selects synchronized cardioversion mode. When the synchronized cardioversion mode is selected the SYNC lamp lights. To select defibrillation mode, press this key again.

5 CHARGE/AED button

Starts to charge the selected energy. When AED mode is selected, starts AED analysis. The defibrillator automatically charges energy when a shockable rhythm is detected.

6 DISCHARGE button When disposable pads or internal paddles are used, discharges the charged energy. When using external paddles, this button is covered.

7 DISCHARGE lamp Blinks when charging completes. When using external paddles, this lamp is covered.

8 ECG input connector Connects to the ECG connection cable.

9 SpO2/CO2 connector Connects to SpO2 adapter or CO2 sensor kit. You can connect one SpO2 adapter and one CO2 sensor kit at the same time. If two SpO2 adapters or two CO2 sensor kits are connected at the same time, only the measurement with the earlier connected connector is available. If the power is turned on with two SpO2 adapters or two CO2 sensor kits connected, only the measurement with the left connector is available. * Option: When DSI interface unit is connected.

10 AUXOUT connector Outputs ECG waveforms when the optional DSI/AUXOUT interface unit is connected.

11 Paddle connector Connects to external paddles, internal paddles or pad adaptor.

1. GENERAL


Top Panel(only for TEC-5531)

3

4

1

5

20

19

12

13

14 15 16 17

18

2

6


12 Record key Starts recording with the recorder. To stop recording, press this key again.

13 Event key Starts event recording. When this key is pressed, the recorded waveforms are saved as an event in the summary recording data.

14 ECG lead key Changes ECG leads. 15 ECG sensitivity key Changes ECG sensitivity. 16 Silence alarms key Temporarily suspends or silences alarms. 17 Multi-function key In the monitor mode, opens the alarm setup screen. You can

confirm or change alarm settings. In AED mode this key changes to Pause key.

18 AC lamp Lights when AC power is supplied to the defibrillator. 19 Battery charging lamp Lights when the battery is being charged.

20 Battery charge complete lamp

Lights when the battery is completely charged.


1 PACING RATE Up key Increases the pacing frequency (pulse/minute). 2 PACING RATE Down

key Decreases the pacing frequency (pulse/minute).

3 PACING OUTPUT Up key

Increases the intensity of the pacing current.

4 PACING OUTPUT Down key

Decreases the intensity of the pacing current.

5 START/STOP key Press to start pacing. Pressing this key again stops pacing. 6 PULSE lamp Blinks in synchronization with the pacing pulse.

1. GENERAL


Left Side Panel

External Paddles

1

44

32

1

4 3

2


1 CONTACT lamp Indicates the quality of contact between paddles and patient. The GOOD lamp must light.

2 CHARGE button Press to charge the selected energy. 3 CHARGE lamp Blinks while the selected energy is being charged. Lights when

the energy is completely charged. 4 DISCHARGE buttons Simultaneously press both buttons to discharge the charged

energy. In synchronized cardioversion, the defibrillator discharges energy at the appropriate timing after these buttons are pressed.


1 Recording paper exit The recorded paper comes from this slit. A cutter to cut the paper is attached here.

2 Door release lever Pull the lever up to open the door. 3 SD card slot Insert an SD card here. To remove the card, push it in. 4 Battery pack holder Contains the battery.

1. GENERAL


Rear Panel

1 2


1 AC SOURCE socket Connects the AC power cord to supply AC power. 2 Optional unit connector Optional unit is connected. When not used, attach the cover

here.

1. GENERAL


Important Safety Information

GeneralDANGER

• Never use the defibrillator in the presence of any flammable

anesthetic gas or high concentration oxygen atmosphere. Failure to

follow this warning may cause explosion or fire.

• Never use the defibrillator in a hyperbaric oxygen chamber. Failure

to follow this warning may cause explosion or fire.

WARNING• The defibrillator generates high voltage. The defibrillator must only

be operated by trained and qualified medical personnel.

• Radiofrequency or Electromagnetic Field

Do not use any kind of non-essential non-patient care device within a

radius of 1 meter around the defibrillator. The use of non-essential

non-patient care devices that emit radiofrequency or

electromagnetic fields may interfere with the operation of the

defibrillator by causing noise on the ECG waveform or error

messages. If a non-essential non-patient care device is accidentally

placed near the defibrillator, quickly remove it.

• MRI examination

- Do not install this defibrillator in an MRI examination room. The

defibrillator may not operate properly due to high-frequency

magnetic noise from the MRI.

- When performing MRI tests, remove all electrodes and transducers

from the patient which are connected to this defibrillator. Failure

to follow this warning may cause serious electrical burn on the

patient due to local heating caused by dielectric electromotive

force. For details, refer to the instruction manual for the MRI.

• Using with ESU

- When the defibrillator is used with an electrosurgical unit (ESU),

firmly attach the entire area of the ESU return plate. Otherwise,

the current from the ESU flows into the electrodes of the

defibrillator, causing electrical burn where the electrodes are

attached. For details, refer to the ESU manual.

- When using an ESU, use this defibrillator only in the MONITOR

mode and use the ECG electrodes for monitoring. Do not monitor

ECG with disposable pads, external paddles or internal paddles. If

ECG is monitored with pads or paddles, high frequency energy

from the ESU causes abnormal current to flow in the patient and

unexpected discharge. This may damage the defibrillator.

1. GENERAL


Installation

WARNING continued• Surrounding Conditions

Fluids such as Ringer’s saline solution and blood are excellent

electrical conductors; to avoid creating potentially dangerous

electrical paths, keep the defibrillator and the immediate area clean

and dry at all times.

CAUTION• Install the defibrillator and ESU appropriately and perform

equipotential grounding. Otherwise, noise from the ESU may be

falsely recognized as QRS and ECG monitoring might not be

performed properly.

• Only use Nihon Kohden specified parts and accessories. When other

parts or accessories are used, the defibrillator heats up and may be

damaged, and monitoring stops.

• Do not reuse disposable items.

• Turn off the power of cellular telephones, small wireless devices and

other devices which produce strong electromagnetic interference.

Otherwise, the waveforms and measurements are affected by

interference and the displayed data may be incorrect.

WARNING• Connect only the specified instrument to the defibrillator and follow


electrical shock or injury to the patient and operator, and cause fire

or instrument malfunction.

• Only use the provided power cord. Using other power cords may

result in electrical shock or injury to the patient and operator.

• Only use the provided power cord. When the provided power cord

cannot be used or when equipotential grounding is doubtful (such as

in poor grounding facility), operate the defibrillator on battery

power. Otherwise, the patient and operator may receive electrical

shock or injury.

• When several medical instruments are used together, ground all

instruments to the same one-point ground. Any potential difference

between instruments may cause electrical shock to the patient and

operator.

• Do not connect several grounding leads directly to the equipotential

terminal because the grounding lead may be disconnected from the

terminal.

1. GENERAL


Battery

CAUTION• The defibrillator should only be connected to external equipment

which complies with the CISPR 11 Second Edition 1990-09, Group 1

and Class B standard.

• Only use the KD-028A cart for this defibrillator. If another cart is

used, it may tip over or the defibrillator may fall off.

• Assembly and disassembly of any component in the instrument

should only be done by qualified service personnel.

DANGER• Keep the battery pack away from fire. Do not heat the battery pack.

If the battery pack is heated, the substance inside the battery squirts

out and the battery pack explodes.

• Never connect the + and – terminals on the battery pack with a wire.

Never store the battery pack with metals such as necklace or hair

pins. The battery pack may short-circuit, causing the substance

inside the battery to leak or explode.

• Never disassemble or modify the battery pack. Never damage or

directly solder the sheath tube. The battery pack may short-circuit,

the substance inside the battery may squirt out and the battery pack

may explode.

• Do not subject the battery pack to a strong shock. The battery may

leak and explode.

• Do not use a battery which is damaged, such as from falling. The

battery has a gas discharge valve and if this valve is damaged, the

gas cannot be discharged, causing the battery to explode.

• If the battery pack is damaged and the substance inside the battery

(alkaline liquid) contacts the eyes or skin, wash immediately and

thoroughly with water and see a physician. Never rub your eyes,

because you may lose your eyesight.

• The battery pack has + and – polarity. Make sure that the battery is

installed in the correct direction. Do not connect the battery with

force if it cannot be connected easily. If the battery is connected with

the wrong polarity, the substance inside the battery may leak and

explode.

• Do not charge the battery pack with an instrument other than this

defibrillator. With another instrument, abnormal current flows and

the battery may leak and explode.

• Do not connect the battery pack to an AC outlet or lighter socket in a

car. The battery may leak and explode.

1. GENERAL


WARNING• Test the battery once a month.

• When you start using a new battery pack, write the date of first use

on the labels on the battery pack and defibrillator.

• Replace the battery pack every year.

• If defibrillation or cardioversion is necessary during the battery test,

cancel the battery test and operate the defibrillator on AC power. Do

not use battery power because the battery may have been

discharged by the battery test.

• Do not immerse the battery pack in water. The battery heats up and

rusts and the substance inside the battery leaks.

• Never use a battery pack which is damaged, discolored or has

leakage. The battery may explode if used.

• Do not leave the battery unused for more than about one year. The

battery may leak.

CAUTION• When inserting or removing the battery, disconnect the power cord

from the defibrillator. Otherwise, the operator may receive electrical

shock.

• To keep the battery fully charged, always keep the power cord

connected to the AC outlet even when the defibrillator is not used.

Otherwise, the battery may discharge and become unusable.

• Do not expose the battery pack to direct sunlight or leave in a high

temperature place. The lifetime of the battery pack may be

shortened, the performance of the battery pack may be degraded

and the battery may leak.

• The battery pack must be inserted by a qualified service personnel.

• Keep the battery pack away from children.

NOTEBefore disposing of the battery, check with your local solid waste

officials for details in your area for recycling options or proper

disposal. The battery is recyclable. At the end of its useful life, under

various state and local laws, it may be illegal to dispose of this battery

into the municipal waste stream.

1. GENERAL


Disposable PadsWARNING

• Failure to follow the warnings below may cause skin burn or

insufficient energy discharge and insufficient pacing current to the

heart.

- Do not reuse disposable pads.

- If the pad package is torn, dispose of the pads and do not use

them.

- Do not use the pads if they are past the expiration date on the

package.

- Use the disposable pads as soon as possible after opening the

package.

- Do not use the disposable pads if the gel has become dry or if the

gel has become abnormal (the gel has become liquid or is coming

off the edges of the pad, etc).

- Do not use the disposable pads if the gel is dark brown or dark

brown gel is on the protective sheet.

• If any pad or connector gets wet, replace it with a new one. If a wet

pad or connector is used, it may cause electrical shock.

• When using the disposable pads for long term pacing, replace them

every hour. Failure to follow this warning may cause skin burn or

insufficient energy discharge and pacing current to the heart.

CAUTION• When using the disposable pads for long term ECG monitoring,

replace them every 24 hours. Failure to follow this instruction may

cause insufficient pacing current and insufficient energy discharge to

the heart.

• Do not attach a disposable pad over another pad. It may cause skin

burn on the patient.

• Do not put heavy objects on the disposable pads or bend the pads. If

the pads get damaged or deteriorated, it may cause skin burn on the

patient.

1. GENERAL


Defibrillation,Cardioversion and AED

General

WARNING• Before defibrillation and cardioversion, make sure that no one is in

contact with either the patient or any metal part of any equipment or

cables which supports or is connected to the patient. Failure to

follow this warning causes serious electrical shock or injury.

• Before defibrillation and cardioversion, remove from the patient all

electrodes, probes and transducers from a connector that do not

have a “ ” or “ ” mark. Otherwise, the operator may receive

electrical shock and the connected instrument may be damaged.

• Before defibrillation and cardioversion, remove everything

(electrodes, patches, etc.) from the patient’s chest. When the

defibrillator paddle directly contacts these materials, the discharged

energy may cause skin burn to the patient.

• Before defibrillation and cardioversion, check that the cords and

cables of the electrodes, probes and transducers attached to the

patient are properly connected to a connector that has a “ ” or

“ ” mark. Touching the metal parts of the disconnected cords and

cables may cause electrical shock or injury by discharged energy.

• Do not move the defibrillator when any charged energy remains in

the defibrillator. If the defibrillator receives any impact, such as

from falling, it discharges energy that can cause electrical shock.

• For this defibrillator, the CONTACT lamp on the STERNUM paddle

indicates skin-paddle contact impedance. If the yellow or orange

lamp lights, the defibrillator may cause serious electric burn on the

patient’s skin and poor energy discharge to the patient. In case of

an emergency, medical personnel should decide whether to execute

discharge immediately, regardless of the CONTACT lamp display, or

take action to make good contact before discharge.

• Pay careful attention to the selected energy when using the pediatric

electrode plates. Applying high energy with the pediatric electrode

plates can cause skin burn because the electrode plates are small.

• Use the ECG monitoring electrodes (disposable electrodes) to

monitor the ECG waveforms. Stable ECG cannot be acquired with

the PADDLE lead because it is difficult to hold the paddles stable.

ECG acquired from external paddles, internal paddles or disposable

pads is unstable after discharge because of high polarization

voltage.

• Do not perform defibrillation or cardioversion in a wet place. Before

defibrillation or cardioversion, move the patient and defibrillator to a

dry place. Otherwise the operator may get electrical shock.

• Never discharge near a person or object other than the patient or

test electrode plate or energy checker. It may cause electrical shock

to the person or damage the object.

• Confirm that there is no noise on the ECG. Noise may be

misrecognized as QRS and discharge might not synchronize with the

patient’s QRS.

1. GENERAL


WARNING continued• Do not perform synchronized cardioversion with the PADDLE lead

unless it is absolutely necessary. In synchronized cardioversion with

the PADDLE lead, noise may be misrecognized as QRS and

discharge might not synchronize with the patient’s QRS.

• Never select “TEST” for the ECG lead. “TEST” is for maintenance

and the waveform displayed on the screen is not the patient’s ECG.

If synchronized cardioversion is performed with the TEST lead, the

discharge is not synchronized with the patient’s QRS and it may

cause ventricular fibrillation.

• If you use the ECG signal from the monitor, before cardioversion,

check that the defibrillator discharge occurs within 60 ms of the peak

of the ECG’s R wave with a delivery checker. If this condition is not

met, the cardioversion may be ineffective or may cause ventricular

fibrillation.

• The apex-posterior placement is not suitable for ECG monitoring or

AED analysis.

• The anterior-posterior placement is not suitable for ECG monitoring

or AED analysis. Use this placement only for pacing.

• Make sure to push the connector of each paddle into the paddle

connector deeply until it clicks. If the connector is not properly

connected, the "Connect paddle" message might not be displayed,

the connector may be disconnected, and the energy might not be

discharged.

• Pay careful attention to the selected energy when performing

defibrillation on children. Performing defibrillation with high energy

may cause fatal damage to the heart.

CAUTION• When performing synchronized cardioversion, confirm that the SYNC

lamp is lit before every discharge. If “Sync mode after CV” is set to

Defib on the System Setup - Configuration screen, the defibrillator

automatically turns to the asynchronous defibrillation mode.

• Have another defibrillator ready in case of defibrillator failure.

When using another defibrillator, remove the paddles of the failed

defibrillator from the patient.

1. GENERAL


With External Paddles

WARNING• Apply contact gel only to the electrode plates of the external

paddles. Otherwise, it may cause electrical shock to the operator.

• Do not apply contact gel by hand. Failure to follow this warning may

cause serious electrical burn, shock, or other injury.

• Do not hold the paddle handles if your hands are wet or have

contact gel on them. This may cause electrical shock to the

operator.

• To avoid skin burn on the patient and poor energy discharge to the

heart, apply contact gel to the electrode plates of the external

paddles.

• Do not touch the electrode plate or edge of the paddle. Failure to

follow this warning may cause serious electrical burn, shock, or

other injury.

• When charging or discharging, do not touch anything other than the

handles. If any other part of the defibrillator is touched during

charging or discharging, the operator receives an electrical shock.

• Before discharging, confirm that the paddles are firmly pressed

against the chest wall. Failure to follow this warning causes skin

burn or poor energy discharge to the heart.

• Do not discharge with the paddles in the air. This may cause

electrical shock to the operator or damage the defibrillator.

• Do not discharge the energy if the paddles are shorted to each other

by contact gel. It may cause skin burn and poor energy discharge to

the heart.

CAUTION• When using the external paddles, connect it to the paddle connector

until it clicks. After connecting the external paddles, use the Basic

checks screen to check that the defibrillator charges and discharges

energy properly. If the energy is not discharged, the connector of

the external paddles is not firmly connected to the paddle connector.

In this case, push the connector of the external paddles into the

paddle connector deeply until it clicks.

• If the patient’s body is wet, thoroughly wipe the moisture off the skin

so that the paddles do not short to each other.

• Do not discharge when the paddles touch each other. This may

damage the defibrillator.

1. GENERAL


guard

With Disposable Pads

WARNING• Do not attach pads on the papilla, electrodes or medicine on the

patient’s body. Failure to follow this warning causes serious skin

burn.

• Fit the pad closely to the body surface so that current flows uniformly

through the pad. Failure to follow this warning causes serious skin

burn or insufficient energy discharge to the heart.

• During charging or discharging, do not touch the pads or connectors.

Failure to follow this warning causes electrical shock to the operator.

• Before discharging, confirm that the pads are firmly applied to the

chest wall. Failure to follow this warning causes skin burn or poor

energy discharge to the heart.

• Do not discharge if the pads overlap each other or are shorted to

each other by anything conductive such as contact gel. This may

cause skin burn and poor energy discharge to the heart.

CAUTION• When connecting the pad adapter to the paddle connector, do not

bend or damage the connector pin. Energy cannot be discharged to

the pads.


so that the pads do not short to each other.

With Internal Paddles

WARNING• Sterilize the internal paddles before use. Failure to sterilize the

paddles may cause serious infection.

• Pay careful attention to the selected energy when using internal

paddles. Applying high energy to the heart may cause cardiac

muscle necrosis. Low energy is recommended.

• During charging and discharging, grip the internal paddles between

the guard at the top of the handle and the cable. If you grip the

handle between the electrode and the guard, you may get an

electrical shock.

• Before discharging, confirm that the paddles are firmly positioned

against the heart. Failure to follow this warning causes serious skin




1. GENERAL


CAUTION• Do not twist the internal paddle while holding the electrode or give

strong impact to the paddle. It damages the electrode.

• When connecting the internal paddles to the paddle connector, do

not bend or damage the connector pin. Otherwise energy cannot be

discharged to the paddles.

• Do not discharge when the paddles touch each other. This may


AED



burn.




• When you perform defibrillation in an ambulance, stop the car.

• During charging or discharging, do not touch the pads or

connectors. Failure to follow this warning cause electrical shock to

the operator.







CAUTION• Before AED analysis or defibrillation, confirm that the patient is

unconscious and has no respiration and no pulse.

• The ECG of a child or a patient with an implanted pacemaker cannot

be analyzed correctly. For these patients, follow the physician’s

instruction.

• Before AED analysis, if the ECG baseline wanders, remove the

causes. Otherwise, correct analysis result cannot be obtained.

• During AED analysis, stop life saving treatment such as CPR. Do not

touch or move the patient, pad adapter and disposable pad cable.

Correct analysis result cannot be obtained.

• When connecting the pad adapter to the paddle connector, do not


the pads.



1. GENERAL


Pacing

CAUTION continued• Do not discharge when the paddles touch each other. This may


• Asystole is not judged to be a shockable rhythm and the defibrillator

does not automatically charge the energy.

WARNING• Do not perform pacing while using an ESU. Before using the ESU,

turn the defibrillator power off and remove disposable pads from the

patient. Otherwise, high frequency energy from the ESU causes

abnormal current to flow into the patient and causes electrical burn,

shock or other injury. It also damages the defibrillator.

• Always monitor the ECG waveform with the ECG connection cable

and ECG electrodes.


misrecognized as QRS and correct pacing cannot be performed.

• Do not touch the patient, pads or connectors during pacing. It may

cause electrical shock.

• The pacing rate must be determined by qualified medical personnel

based on the heart rate of the patient in a normal state.

• The pacing current must only be increased by qualified medical

personnel decision.

• Keep the current intensity as low as possible to minimize pain and

discomfort to the patient.

• Failure to follow the following warnings causes serious skin burn.

- Do not attach the pads over ECG electrode.

- Do not attach pads on the papilla or medicine on the patient’s

body.

- Fit the pad closely to the body surface so that current flows

uniformly through the pad. This reduces the required pacing

current and pain and discomfort to the patient.


AED analysis.



• Never select “TEST” for the ECG lead. “TEST” is for maintenance

and the waveform displayed on the screen is not the patient's ECG.

• Do not change the sensitivity or ECG lead setting after pacing is

started. If one of these settings is changed, the pacing stops for 3

seconds. Failure to follow this warning may cause serious heart

attack.

• No QRS wave is detected:

- For 240 ms after the pacing pulse is output, if the pacing rate is set

to 100 ppm or more.


to 90 ppm or less.

1. GENERAL


ECG Monitoring

CAUTION• Check that the pacing pulse is effective by observing ECG on the

screen.

• When connecting the pad adapter to the paddle connector, do not


the pads.



WARNING• When using a defibrillator together with the monitor, use Ag/AgCl

electrodes. Other types of electrodes, stainless steel in particular,

will adversely affect the ECG waveform by slowing the baseline

recovery on the monitor and result in no monitoring immediately

following defibrillation.

• Keep pacemaker patients under close observation. The pacemaker

rate may be counted during cardiac arrest and certain arrhythmias.

Do not rely only on heart rate alarms and the displayed heart rate.


AED analysis.



• With the pacing pulse rejection ON, narrow width QRS of a

premature baby or infant cannot be detected correctly and the

defibrillator may miscount QRS. In this case, set the pacing pulse

rejection to OFF.

• Turn the pacing pulse rejection to OFF when monitoring a child.

With the pacing pulse rejection ON, narrow width QRS of a child

cannot be detected correctly and the defibrillator may miscount

QRS.

CAUTION• When the “Check ECG Electrodes” message is displayed, ECG is not

monitored properly and the ECG alarm does not function. Check the

electrode, electrode leads and connection cord, and if necessary,

replace with new ones.

• Turn the pacing pulse rejection to On when monitoring a pacemaker

patient. Otherwise QRS and pacemaker spike might not be

distinguished and pacing failure might not be recognized.

1. GENERAL


SpO2 MonitoringWARNING

• SpO2 Measurement may be incorrect in the following cases.

- When the patient’s carboxyhemoglobin or methemoglobin

increases abnormally

- When dye is injected in the blood

- When using an electrosurgical unit

- During CPR

- When measuring at a site with venous pulse

- When there is body movement

- When the pulse wave is small (insufficient peripheral circulation)

• When not monitoring SpO2, disconnect the SpO2 connection cord

from the bedside monitor. Otherwise, noise from the probe sensor

may interfere and incorrect data is displayed on the screen.

• Check the circulation condition by observing the skin color at the

measurement site and pulse waveform. Change the measurement

site every 8 hours. The skin temperature may increase at the

attached site by 2 or 3°C (4 or 5°F) and cause a burn or pressure

necrosis. When using the probe on the following patients, take

extreme care and change the measurement site more frequently

according to symptoms and degree.

- Patient with a fever

- Patient with a peripheral circulation insufficiency

- Neonate or low birth weight infant with delicate skin

• When using probes other than the TL-201T finger probe, to avoid

poor circulation, do not wrap the tape too tight. Check the blood

circulation condition by observing the skin color and congestion at

the skin peripheral to the probe attachment site. Even for short-term

monitoring, there may be burn or pressure necrosis from poor blood

circulation, especially on neonates or low birth weight infants whose

skin is delicate. Accurate measurement cannot be performed on a

site with poor peripheral circulation.

• When measuring SpO2 of a patient who is in a state of shock or in

CPR (cardiopulmonary resuscitation), the acquired SpO2 data may be

incorrect due to the patient’s body movement.

• Do not use the probe during MRI examination because it may cause

skin burn on the probe attachment area. For details, follow the MRI

operator’s manual.

1. GENERAL


CAUTION• For long term monitoring, check the circulation condition by

observing the skin color the measureing site. To avoid circullation

insufficiency and skin burn, change the measurement site every

specified hours. Reffer to the operator’s manual of the plobe you

use.

• Do not pull or bend the probe cable, and do not put caster feet on

the probe cable. Do not immerse the probe cable in chemical

solutions or water. Failure to follow these instructions may cause

cable discontinuity, short circuit, skin burn on the patient and

incorrect measurement data. Replace any broken probe with a new

one.

• Turn off the power of mobile phones, small wireless devices and

other devices which produce strong electromagnetic interference

around a patient (except for devices allowed by the hospital

administrator). Radio waves from devices such as mobile phones or

small wireless devices may be mistaken as pulse waves and the

displayed data may be incorrect.

• Only use the specified probes. Otherwise SpO2 cannot be monitored

properly and instrument performance may be degraded.

• Do not use a probe which is past the expiration date on the package.

• Do not use a damaged or disassembled probe. It causes incorrect

measurement and may injure the patient.

• The disposable probe is not sterilized. Use the disposable probe only

for a single patient. Never reuse the disposable probe for another

patient because it causes cross infection.

• If the attachment site is dirty with blood or bodily fluids, clean the

attachment site before attaching the probe. If there is nail polish on

the attachment site, remove the polish. Otherwise, the amount of

transmitted light decreases, and measured value may be incorrect or

measurement cannot be performed.

• If the skin gets irritated or redness appears on the skin from the

probe, change the attachment site or stop using the probe. Take

extreme care for the patients with delicate skin.

• If the probe is attached to the same limb that is used for NIBP

measurement or an IBP catheter, the blood circulation at the

attachment site is affected and the measurement might not be

correct.

Attach the probe to a limb where the blood circulation is not

affected.

• If patient’s nail is long, cut it or attach the probe to another finger.

The probe cannot be attached properly to a finger with a long nail.

• Refer to the probe instruction manual for details.

• Neonatal skin is delicate. Remove the probe and tape carefully and

slowly.

• When removing the probe from the attachment tape, do not pull the

sensor cable because this can damage the cable.

1. GENERAL


CO2 Monitoring

CAUTION continued• When the probe is attached on an appropriate site with sufficient

circulation and an error message about probe attachment repeatedly

appears, the probe may be deteriorated. Replace it with a new one.

• When a message indicates a faulty probe or faulty SpO2 adapter,

stop monitoring and replace the probe or SpO2 adapter with a new

one.

• Do not use a probe which is deteriorated by aging. Accurate


• Do not use disposable probes for other patients. If the probe is dirty

with blood or bodily fluids, replace it with a new one.

• While a patient is on medication which causes vasodilation, the

pulse waveform may change and in rare cases the SpO2 value might

not be displayed.

• Do not use creosol soap, glutaraldehyde, sodium hypochlorite, or

benzalkonium chloride because they damage the probe.

• Do not soak the probe in cleaning solution because it is not

waterproof.

WARNING• When performing defibrillation or cardioversion during CO2

monitoring with the CO2 sensor kit, remove the sensor from the

patient. When the sensor cannot be removed, do not touch the

sensor cable because the discharged energy may cause serious

electrical burn, shock or other injury.

• With the TG-901T3 CO2 sensor kit, measurements are based on the

assumption of no CO2 gas in the inspiration. The CO2 concentration

in the respiration is calculated by taking the CO2 concentration in

the inspiration as 0 mmHg. Therefore, measuring CO2 by connecting

the CO2 sensor kit to a patient under mouth-to-mouth respiration or

to a Jackson Rees circuit or Mapleson D circuit where CO2 gas may

be present during inspiration may result in the acquired data being

lower than the actual value.

• With the TG-901T3 CO2 sensor kit, this monitor cannot monitor CO2 of

patients weighing less than 10 kg (22 lbs).

• Before MRI examination, remove the CO2 sensor kit from the patient.

Failure to follow this warning may cause serious electrical burn on

the patient due to local heating caused by dielectric electromotive

force. For details, refer to the MRI operator’s manual.

1. GENERAL


CAUTION• The CO2 data may be inaccurate when monitoring a patient with an

extremely high respiration rate or irregular respiration. Read the

measured values carefully.

• Measured value may be incorrect when the operating temperature

changes greatly.

• When the “CO2 sensor not working” or “CO2 adapter abnormality”

message is displayed, check the CO2 sensor kit and replace it if

necessary. CO2 cannot be monitored while the message is

displayed.

• Follow the CAUTION label on the CO2 gas cylinder.

• When using an anesthetic instrument with a volatile anesthetic

agent, the CO2 measurement may be inaccurate.

WARNING• Do not use the airway adapter on neonates because the dead space

volume of the airway adapter is about 5 mL.

• When using the YG-101T airway adapter on children or patients with

low ventilatory amount, the CO2 may mix in the inspiration due to

the airway adapter’s dead space volume (5 mL), resulting in

inaccurate measured values or difficulty in detecting apnea.

Perform ventilation taking into consideration the 5 mL dead space

volume.

• When using the YG-121T nasal adapter on children or patients with


the nasal adapter’s dead space volume (1.2 mL), resulting in


Perform ventilation taking into consideration the 1.2 mL dead space

volume.

• When you use YG-122T together with an oxygen cannula, check that

the oxygen cannula is correctly attached on the patient by referring

to other parameters and by observing the patient periodically.

• If arterial oxygen saturation does not increase, immediately stop

using the oxygen cannula with the CO2 sensor kit and select another

way to supply oxygen.

• The only oxygen cannula that can be used with YG-122T is #1103

manufactured by HUDSON RCI. Do not use any other oxygen

cannula. Other oxygen cannulas cannot be attached and oxygen

cannot be delivered to the patient through the nostrils.

• Check that the oxygen cannula tube is not bent, broken, or blocked

by the nasal tube. If the ends of the oxygen cannula tube turn too far

up or down, it causes insufficient oxygen supply or the CO2 value

may be incorrect.

CO2 Sensor Kit and AirwayAdapter

1. GENERAL


CAUTION• The airway adapter/nasal adapter is non-sterilized and disposable.

Use only for a single patient and single use. Failure to follow this

instruction causes cross infection.

• Do not sterilize the airway adapter. Safety cannot be guaranteed if

the airway adapter is sterilized.

• Use the Nihon Kohden specified airway adapter.

• With the TG-901T3 CO2 sensor kit, secure the CO2 sensor to the

respiration circuit so that the transparent film of the airway adapter

is perpendicular to the floor. If the transparent film is parallel to the

floor, water droplets may get onto the transparent film and affect the

measurement accuracy.

• Failure to follow the instructions below degrades the anti-fogging

ability of the transparent film and results in incorrect measurement.

- Replace the airway adapter/nasal adapter with a new one every 24

hours.

- Replace the airway adapter/nasal adapter with a new one if blood,

sputum or mucus adhere to the transparent film.

- Do not damage the transparent film. Do not let dust or detergent

contact the transparent film. Do not touch, wipe or clean the

transparent film with fingers or cleaners.

• Never autoclave or perform EOG gas sterilization for the TG-901T3

CO2 sensor kit. It damages the CO2 sensor kit and safety cannot be

guaranteed.

• When using the YG-121T/YG-122T nasal adapter on a patient with

bleeding disorder, poor general medical condition or malnutrition,

observe the patient condition all the time. The mouth guide touches

the mouth and may cause pressure sores.

WARNING• During alarm suspension (“Alarm off” or “Alarms suspended”

message displayed), all current alarms except for instrument alarm

group 1 are turned off.

• When admitting a new patient, check the alarm settings.

CAUTION• When the alarm limit is set to OFF, there will be no alarm for that

limit. Be careful when you set the alarm limit to OFF.

• Alarms about a parameter do not occur until the measurement of the

parameter starts.

Alarms

1. GENERAL


Maintenance

Storage

WARNING• When performing energy discharge test, keep the paddles in the

paddle holders when discharging the energy. Do not discharge with

the paddles in the air or when the paddles are shorted. Failure to

follow this warning may cause electrical shock and damage to the

defibrillator.



• If defibrillation or cardioversion is necessary during battery test,




CAUTION• Before maintenance, cleaning or disinfection, turn the defibrillator

power off, disconnect the power cord from the AC socket and then

remove the battery from the defibrillator. Failure to follow this

instruction may result in electrical shock and defibrillator

malfunction.

• Before battery replacement, turn off the defibrillator power and

disconnect the AC power cord from the defibrillator. Otherwise, the

operator may get an electrical shock.

• Assembly and disassembly of any component in the instrument


CAUTION• To prevent overheating, leave the defibrillator lying flat and do not

cover it.

• Store the disposable pads in the environment described on the pads

package. If stored in an environment other than specified, the pads

become unusable.

1. GENERAL


Surrounding sound and ECG waveforms can be recorded in an SD card in the

defibrillation screen, AED screen, pacing screen and monitoring screen. Up to 2

hours of sound recording is available with the QM-064D (64 MB) Holter Card.

You can save report data in the SD card (Refer to “ Setup Screen - Save Report”).

When the SD card is inserted into the defibrillator, recording automatically starts.

To stop recording,

1) Turn the Energy/Mode Select Control to the SETUP position to open the Setupscreen.

2) When the “Can eject SD card” mark appears at the upper corner of the

screen, remove the SD card by pushing it in.

CAUTIONOnly remove the SD card in the Setup screen. Otherwise, the saved

data may be damaged. When the SD card is removed after the power

is turned off, the latest 30 seconds of data is lost.

To play back the recorded sound and ECG waveforms, refer to “System Setup -

Use Voice File”.

Recording Sound

1. GENERAL




Section 2 Preparation

Location ...............................................................................................................................2.1

Power ..................................................................................................................................2.2

AC Operation ............................................................................................................2.2

Battery Operation ......................................................................................................2.2

Using AC Power ..................................................................................................................2.3

Connecting the Power Cord .......................................................................................2.3

Using the Battery ................................................................................................................2.4

Safety Information about Battery Pack ......................................................................2.4

Checking the Battery Pack .............................................................................2.6

Storage ...........................................................................................................2.6

Disposal ..........................................................................................................2.6

Inserting the Battery into the Defibrillator ..................................................................2.7

Charging the Battery Pack ........................................................................................2.8

Trickle Charging .........................................................................................................2.9

Remaining Battery Power Display ........................................................................... 2.10

Loading the Recording Paper ............................................................................................. 2.11

Basic Checks .................................................................................................................... 2.12

Displaying the Basic Checks Screen ...................................................................... 2.12

Check Procedure ..................................................................................................... 2.12

Check Before Use ............................................................................................................. 2.15

Before Turning On the Power ................................................................................... 2.15

Check Items After Turning the Power On ................................................................. 2.15

2. PREPARATION


Location

DANGER• Never use the defibrillator in the presence of any flammable

anesthetic gas or high concentration oxygen atmosphere. Failure to

follow this warning may cause explosion or fire.

• Never use the defibrillator in a hyperbaric oxygen chamber. Failure

to follow this warning may cause explosion or fire.

WARNING• Surrounding Conditions

Fluids such as Ringer’s saline solution and blood are excellent

electrical conductors; to avoid creating potentially dangerous

electrical paths, keep the defibrillator and the immediate area clean

and dry at all times.

• Radiofrequency or Electromagnetic Field

Do not use any kind of non-essential non-patient care device within a

radius of 1 meter around the defibrillator. The use of non-essential

non-patient care devices that emit radiofrequency or

electromagnetic fields may interfere with the operation of the

defibrillator by causing noise on the ECG waveform or error

messages. If a non-essential non-patient care device is accidentally

placed near the defibrillator, quickly remove it.

• Do not install this defibrillator in an MRI examination room. The

defibrillator may not operate properly due to high-frequency

magnetic noise from the MRI.

2. PREPARATION


Power

WARNINGOnly use the provided power cord. When the provided power cord

cannot be used or when equipotential grounding is doubtful (such as

in poor grounding facility), operate the defibrillator on battery power.

Otherwise, the patient and operator may receive electrical shock or

injury.

The defibrillator can operate on either battery or AC power. You can select either

AC or battery (Battery pack NKB-301V: option) according to where the

defibrillator is used.

When the power cord is plugged into an AC outlet, the AC lamp lights. When the

defibrillator power is turned on with the power cord connected to an AC outlet, the

defibrillator operates on AC power. The “ ” mark is displayed on the right upper

screen.

When the battery is inserted and the power cord is disconnected, such as when

transferring a patient, the defibrillator automatically switches to battery power. The

“ ” mark is displayed on the screen.

The battery can be charged only by the defibrillator. The battery is charged when

the power cord is plugged into an AC outlet and AC power is supplied to the

defibrillator. The battery is also charged during operation.

NOTEFor the TFT LCD screen, it is considered normal if some pixels have

randomly abnormal color or do not light.

AC Operation

Battery Operation

2. PREPARATION


Using AC Power

Connecting the PowerCord WARNING

Only use the provided power cord. Using other power cords may

result in electrical shock or injury to the patient and operator.

Connect the provided power cord to the AC SOURCE socket on the rear panel of

the defibrillator and plug the cord into a 3-prong AC outlet. When the 3-prong

power cord is connected to the 3-prong AC outlet with a ground third contact, the

defibrillator is automatically grounded.

When AC power is supplied to the defibrillator, the AC lamp lights.

NOTEIf the AC lamp does not light when the power cord is connected, check

if the power cord is properly connected.

2. PREPARATION


NOTEThe battery lifetime is one year. Before operating the defibrillator on

battery, check the label on the defibrillator for the date the battery was

first used.

When the battery pack NKB-301V (option) is inserted in the defibrillator and the

defibrillator is not connected to AC power, the defibrillator can be operated on

battery. When the power cord is disconnected during AC operation, the

defibrillator automatically switches to battery operation, which enables continuous

operation. When the power cord is connected again, the defibrillator switches to AC

operation automatically.

With the fully charged new battery at 20°C, the defibrillator can perform:

Defibrillation at least 70 discharges at 270 J

Monitoring at least 150 minutes continuous monitoring

Noninvasive pacing at least 90 minutes pacing in FIXED mode at 180 ppm

and 200 mA


Defibrillation at least 50 discharges at 270 J

DANGER• Keep the battery pack away from fire. Do not heat the battery pack.

If the battery pack is heated, the substance inside the battery squirts

out and the battery pack explodes.

• Never connect the + and – terminals on the battery pack with a wire.

Never store the battery pack with metals such as necklace or hair

pins. The battery pack may short-circuit, causing the substance

inside the battery to leak or explode.

• Never disassemble or modify the battery pack. Never damage or

directly solder the sheath tube. The battery pack may short-circuit,

the substance inside the battery may squirt out and the battery pack

may explode.

• Do not subject the battery pack to a strong shock. The battery may

leak and explode.

• Do not use a battery which is damaged, such as from falling. The

battery has a gas discharge valve and if this valve is damaged, the

gas cannot be discharged, causing the battery to explode.

• If the battery pack is damaged and the substance inside the battery

(nickel-metal hydride) contacts the eyes or skin, wash immediately and

thoroughly with water and see a physician. Never rub your eyes,

because you may lose your eyesight.

• The battery pack has + and – polarity. Make sure that the battery is

Using the Battery

Safety Information aboutBattery Pack

2. PREPARATION


installed in the correct direction. Do not connect the battery with

force if it cannot be connected easily. If the battery is connected with

the wrong polarity, the substance inside the battery may leak and

explode.

• Do not charge the battery pack with an instrument other than this

defibrillator. With another instrument, abnormal current flows and

the battery may leak and explode.

• Do not connect the battery pack to an AC outlet or lighter socket in a

car. The battery may leak and explode.

WARNING• Test the battery once a month.

• When you start using a new battery pack, write the date of first use

on the labels on the battery pack and defibrillator.

• Replace the battery pack every year.

• If defibrillation or cardioversion is necessary during the battery test,




• Do not immerse the battery pack in water. The battery heats up and

rusts and the substance inside the battery leaks.

• Never use a battery pack which is damaged, discolored or has

leakage. The battery may explode if used.

• Do not leave the battery unused for more than about one year. The

battery may leak.

CAUTION• When inserting or removing the battery, disconnect the power cord


shock.

• To keep the battery fully charged, always keep the power cord



• Do not expose the battery pack to direct sunlight or leave in a high

temperature place. The lifetime of the battery pack may be

shortened, the performance of the battery pack may be degraded

and the battery may leak.


• Keep the battery pack away from children.

Danger - continued

2. PREPARATION


NOTE• Fully charge the new battery pack before using on the defibrillator.

• Do not use a battery pack which is past the expiration date written

on the label.

• If the battery pack becomes unusable or the available discharge

time has decreased, do not leave the battery pack in the

defibrillator. The substance inside the battery may leak, causing

instrument corrosion and fire. Immediately replace the battery with

a new one.

• Do not leave a battery pack inside the defibrillator without the power

cord connected between the defibrillator and AC outlet. The battery

pack may be over-discharged and can no longer be used.

• When not using the defibrillator for more than six months, remove

the battery pack from the defibrillator and store the battery at

temperatures between −−−−−20°C (4°F) and +++++35°C (95°F) and low humidity.

• Before disposing of the defibrillator, make sure that the battery pack is

removed from the defibrillator.

• Before disposing of the battery, check with your local solid waste

officials for details in your area for recycling options or proper

disposal. The battery is recyclable. At the end of its useful life, under

various state and local laws, it may be illegal to dispose of this battery

into the municipal waste stream.

Checking the Battery Pack

• In order to ensure emergency use of the defibrillator on battery power, perform

the battery test once a month.

• To prevent battery trouble, check the battery appearance every 6 months. If there

is any damage (crack, deformation, cable discontinuity and so on) on the battery

or the battery leaks, replace the battery with a new one. If the battery is dirty

with dust, remove it.

Storage

WARNINGDo not leave the battery unused for more than about one year. The

battery may leak.

• When not using the defibrillator for more than one month, to prevent leaking or

rusting of the battery, remove the battery pack from the defibrillator and store the

battery at surrounding temperatures between -20°C (4°F) and +35°C (95°F) and

low humidity.

• When a battery is not used for over one month, fully charge it before use. Even if

the battery was fully charged before storage, the battery self-discharges and

operation time decreases.

• To ensure full performance of the defibrillator, replace the battery every one year.

• When a battery is stored for a long time, the battery tends to deactivate and the

original battery capacity cannot be used to 100%. The capacity may recover by

repeating full discharging and full charging several times.

2. PREPARATION


* defibrillator standard accessory

** battery standard accessory

Inserting the Battery intothe Defibrillator

Before inserting the battery, check the battery appearance and write the date of first

use on the label on the battery. After inserting the battery, charge the battery.

NOTE• Use only the battery pack NKB-301V.

• Perform the battery test once a month. Check the battery appearance

every 6 months. Replace the battery every one year.


1. Before inserting the battery into the defibrillator, write the date of the first use

on the label on the battery.

2. Confirm that the Energy/Mode Select control is set to OFF. Disconnect the

power cord from the defibrillator.

CAUTIONWhen inserting or removing the battery, disconnect the power cord


shock.

3. Turn the knob on the battery holder cover counterclockwise and remove the

battery pack holder cover.

4. Insert the battery into the battery pack holder.

5. Securely connect the battery connector to the connector inside the battery pack

holder until it clicks and locks.

6. Close the battery pack holder cover. Be careful not to pinch the cable. Secure

the battery pack holder cover by turning the knob clockwise.

7. On the battery check label*, write the date of battery first use and the date the

battery is checked. On the start date label**, write down the date of battery

first use. Attach each label on the defibrillator so that you can see them easily,

for example, on the upper part of the right side panel.

Disposal

The battery is NiMH. Before disposing of the battery, check with your local solid

waste officials for details in your area for recycling options or proper disposal. The

battery is recyclable. At the end of its useful life, under various state and local laws,

it may be illegal to dispose of this battery into the municipal waste stream.

2. PREPARATION


Charging the Battery Pack The battery can be charged only by the defibrillator. When “ 0 ” appears on the

screen, immediately charge the battery. When “ 0 ” is displayed on the screen,

the defibrillator cannot charge the defibrillation or cardioversion energy. The new

battery is not charged.

NOTE• When you use a new battery, charge the battery at least 3 hours until

the battery charge complete lamp lights.

• Always charge the battery pack at surrounding temperatures between

0°C (32°F) and 40°C (104°F). Charging may stop when the battery is

charged at surrounding temperatures higher than 45°C (113°F). In this

case, move the defibrillator to a cooler place. When the battery

temperature decreases, the battery charging resumes.

• Charge the battery pack only by the defibrillator. If the battery pack is

charged with another instrument, abnormal current flows, the

substance inside the battery leaks and the battery explodes. Also it

causes defibrillator malfunction and instrument trouble.

• When charging the battery, confirm that the AC lamp is lit and either

the battery charging lamp or battery charge complete lamp is lit.

• Charge the battery pack immediately after it is used. If it is left

uncharged, the battery will become unusable because of over-

discharge.

Charging procedure

1. Set the Energy/Mode Select control to the OFF position.

2. Connect the power cord to the defibrillator. The battery charging lamp on the

front panel lights and the charging (rapid charging) starts.

NOTEDo not disconnect the power cord until charging finishes.

3. When rapid charging finishes, the battery charge complete lamp lights.

9. Reset the date of first use of the battery.

1) Display the System Setup - Battery Test screen.

2) Press the Reset key to reset the date of first use of the battery. The “Time

to replace battery” message appears one year after the Reset key is pressed.

NOTEYou must do this step when the battery is replaced. Otherwise, the

defibrillator does not display the “Time to replace battery” message

to prompt you to replace the battery.

2. PREPARATION


Trickle Charging After battery charge complete lamp lights, keep the power cord connected to the

AC outlet regardless of whether the defibrillator is used or not. The trickle charge

starts in order to keep the battery fully charged.

CAUTIONTo keep the battery fully charged, always keep the power cord



NOTE• When the defibrillator operates on a fully charged battery and “ ”,

“ 1 3 ” or “ 0 ” appears soon, the battery is deteriorated. Check the

capacity by the battery test. If a “Battery WEAK” or “Replace battery”

message appears, replace the battery with a new one.

• Perform the battery test once a month.

Trickle charge

Trickle charge is a method to charge with small current to compensate for the loss

by self discharge. This prevents the decrease of battery capacity caused by self

discharge.

NOTE• When the battery charging lamp continues to be lit over 5 hours (the

battery charge complete lamp does not light), the battery is abnormal.

Perform battery test and if the battery proved to be abnormal, replace

it with a new one.

• Blinking battery charging lamp indicates that the temperature inside

the defibrillator is rising. In this case, immediately quit charging.

Move the defibrillator to a cool place and start charging again.

Charging starts after the temperature inside the defibrillator

decreases.

2. PREPARATION


Remaining Battery PowerDisplay

When the defibrillator operates on battery, the remaining battery power is

displayed on the top right of the screen. When a message appears, an alarm

sounds.

NOTE• The values in the table are under the condition that the battery is

handled as specified in this manual. The value is affected by the

battery usage and storage conditions. While the recorder is running,

the operation time is shorter than indicated in the table.

• The defibrillator cannot charge energy when the battery mark is

blinking. Immediately connect the defibrillator to AC power or

replace the battery with a fully charged one.

• When using a battery that is not fully charged, the remaining battery

power display may be incorrect.

* displayed for 5 or 6 seconds.

1 3

0

Mark Message Remaining Battery Power Available discharges (20°C, 270 J charge)

--- Remain enough 40 discharges or more

*

--- Remain about 2/3 About 20 to 40 discharges

Battery discharged*

Remain 1/3 or less About 4 to 20 discharges

Battery discharged Battery is discharged. Replace the battery with a charged battery or switch to AC operation.

3 discharges or less

Charge battery Cannot operate on battery. The power turns off soon. Replace the battery with a charged battery or switch to AC operation.

Not available

2. PREPARATION


Loading the Recording Paper

NOTEOnly use the FQS50-2-100 Z-fold type recording paper.

1. Pull the door release lever of the recorder up to open the door. For safety, the

door stops half-open. Pull the door completely down with your hand.

2. Set the recording paper inside the recorder with the printed side up.

To load z-fold recording paper, first pull the slide plate toward you until it

clicks and load the paper.

To load roll type recording paper, first push the slide plate back to the inside

until it clicks and load the recording paper in the hollow.

3. Draw out the paper toward you and close the door until it clicks.

4. Press the Record key on the front panel to feed the recording paper.

2. PREPARATION


With the basic checks, the following five functions are checked. Perform the basic

checks everyday.

• Discharge check

• Battery check

• Recorder check

• Alarm check

• Voice check

• Pacing check (TEC-5531 series only)

• Defibrillation waveform check

Turn the Energy/Mode Select control to the BASIC CHECK position. The Basic

checks screen appears.

Check Procedure

Basic Checks

Displaying the BasicChecks Screen

VF/VT :In the Basic checks screen, the VF/VT detection function isautomatically turned off.

WARNINGWhen performing energy discharge test, keep the paddles in the

paddle holders when discharging the energy. Do not discharge with

the paddles in the air or when the paddles are shorted. Failure to

follow this warning may cause electrical shock and damage to the

defibrillator.

NOTE• When the Basic checks screen is displayed, the waveform is

automatically switched to TEST and the patient ECG waveform is not

monitored. To monitor the patient, finish the basic checks or turn the

Energy/Mode Select control to the MONITOR position.

• Do not continuously perform the “Basic checks” more than the

specified number of charge/discharge cycles. Refer to “Specification -

Defibrillator - Maximum continuous charge/discharge cycles at 270 J”

in Section 11.

2. PREPARATION


Recording example of the discharge check

When you start basic checks, all items are checked automatically. Follow the

instruction on the screen and press the corresponding key.

Results are displayed in the right column for each item as “ ”(pass) or “ ”

(fail). When all items are finished, the results are recorded on the recording paper.

For failed items, the defibrillator may be faulty. Contact your Nihon Kohden

distributor or representative.

1. Press the OK key to start basic checks. Discharge check starts. Press the

Cancel key to cancel the item which is currently checked and start checking

the next item.

1) Discharge check

Energy charging starts. The CHARGE lamp blinks, there is a beeping sound

and a “CHARGING **J” message is displayed on the screen.

When charging completes, the CHARGE lamp lights and there is a continuous

buzzing sound. Confirm that “270 J” and “CHARGED” messages appear on

the screen. Then, the “Press discharge buttons until discharge” message

appears. With the paddles in the paddle holder, simultaneously press both

DISCHARGE buttons on the external paddles. Hold the buttons pressed until

energy is discharged to the paddle holders. The energy is discharged in

synchronization with the TEST waveform.

Check that the displayed energy value becomes “0J” and “ ” is displayed on

the screen.

2) Battery check

Check that “ ” is displayed on the screen.

3) Recorder check

A “Did the recorder print?” message is displayed on the screen. Press the Yes

key when paper was output, and the No key when paper was not output.

4) Alarm check

A “Did the alarm sound?” message is displayed. Press the Yes key when the

alarm sounded, and the No key when the alarm did not sound.

2. PREPARATION


5) Voice check

A “Was the voice heard?” message is displayed and there is a voice “Use

disposable paddle”. Press the Yes key when the voice was heard, and the No

key when the voice was not heard.

6) Pacing check

NOTE• Check that the external paddles are properly placed on the paddle

holders and that the external paddle connector is firmly connected to

the paddle connector. Otherwise, the pacing check does not start.

During the pacing check, if an external paddle is removed from the

paddle holder or the external paddle connector is disconnected, the

pacing check stops. When the external paddle is redurned to the

paddle holder or the external paddle connector is reconnected, the

green paddle contact lamp lights and 5 seconds later the pacing check

resumes at 50 mA pacing current.

• During this check, QRS synchronization point is not displayed.

This check is only abilable for the TEC-5531 Series Defibrillator. The pacing

monitor in the defibrillator checks the eight pacing pulses output from the

external paddles. The check is performed by changing the pacing current as

follow.

Pacing mode: fixed

Pacing rate: 180 ppm (fixed)

Pacing pulse: 50 → 100 → 150 → 200 mA

The detected pacing pulse is displayed with an “*” mark for each current.

2. When all checks finish, a “Basic checks complete” message appears on the

screen and the check result is recorded on the recording paper.

If a “Use another instrument” message appears, stop using the defibrillator and

contact your Nihon Kohden distributor or representative. If any item fails,

contact your Nihon Kohden distributor or representative.

3. Defibrillation waveform check

The defibrillation waveform that is output in the Discharge check

can be displayed by pressing the Wave shape key. To return to

the Basic check menu, press the return key.

NOTE• On the Basic checks screen, if the Energy/Mode Select

control is set to positions other than BASIC CHECK, the

Basic checks screen immediately closes and switches to

the screen of the selected mode.

• Make sure that the time printed on the recording paper is

correct. The date and time on the recording paper are

important information of the medical record.

2. PREPARATION


Check Before Use

Before Turning On thePower

Check Items After Turningthe Power On

Before use, do the following checks to confirm that the defibrillator is in normal

condition and can be used safely. If there is any abnormality, take appropriate

remedial actions referring to the “Maintenance” section in this manual. If the

defibrillator seems to be faulty, attach a “Not available” or ”Repair request” label

on the defibrillator and contact your Nihon Kohden distributor or representative.

Before turning on the power, check the following items.

Accessories

• Paddles, pads and cables prepared

• Sufficient recording paper

• Sterilized internal paddle electrode prepared, if necessary

• Sufficient disposable pads, if necessary

• Sufficient contact gel (GELAID)

• Sufficient number of disposable electrodes

Connection and Setting

• Specified 3-prong power cord and ground lead are properly connected

• Recording paper is loaded

• Battery is fully charged (battery charge complete lamp is lit)

Overview

• Defibrillator is not dirty, rusted, damaged or in contact with liquid

• Operation panel is not torn or broken

• All keys, buttons and control are undamaged and function properly

• Power cord, cables and pins of the paddle connector are not frayed or damaged

Power on

• The AC lamp lights when the power cord is connected to the defibrillator.

• There is no fire, smoke or smell.

• There is no electrical shock when touching the defibrillator.

• Defibrillator is not abnormally hot.

• Defibrillator does not affect surrounding equipment.

Basic operation

• The screen display is correct. (brightness, distortion)

• Lamp indication is correct.

• All keys, buttons and control operate properly.

• All settings are correct.

• The battery is fully charged.

• No abnormality is found in the basic checks. (No abnormality in charging/

discharging, battery, recorder, alarm sound, voice and pacing check)

• Time printed on the recording paper is correct.

2. PREPARATION


• Alarm functions properly.

• The paper is fed correctly. (no wandering or jam)

• Recorded waveforms and letters are clear.

• There is no error message or abnormal operation.

Alarm

• Alarm settings are correct.

NOTEMake sure that the date and time printed on the recording paper is

correct. The date and time on the recording paper are important parts of

the medical record.


Section 3 System Setup Screenand Setup Screen

System Setup Screen .........................................................................................................3.2

How to Change the Items on the System Setup Screen ...........................................3.2

Configuration .............................................................................................................3.3

Setting List ......................................................................................................3.4

Setting Description ..........................................................................................3.6

Battery Test ............................................................................................................. 3.12

HV Capacitor Test ................................................................................................... 3.12

Recorder Check ...................................................................................................... 3.12

System Information ................................................................................................. 3.12

Report History ......................................................................................................... 3.12

Use Voice File ......................................................................................................... 3.13

Setup Screen .................................................................................................................... 3.14

Setup Item List ....................................................................................................... 3.14

How to Change the Settings on the Setup Screen .................................................. 3.15

Paddle Setup ........................................................................................................... 3.16

ECG Setup .............................................................................................................. 3.16

SpO2 Setup ............................................................................................................. 3.16

CO2 Setup ............................................................................................................... 3.16

Report Setup ........................................................................................................... 3.16

Recorder Setup ....................................................................................................... 3.16

Date/Screen ............................................................................................................ 3.16

Date and Time ............................................................................................... 3.16

2nd Wave ...................................................................................................... 3.17

QRS Setup .............................................................................................................. 3.17

Alarm Setup ............................................................................................................ 3.17

Save Report ............................................................................................................ 3.18

3. System Setup Screen and Setup Screen


You can change the hardware and software settings on the Setup screen and System

Setup screen. The System Setup screen also provides the hardware check

functions.

When a Setup or System Setup screen is opened, the ECG lead key, ECG sensitivity

key, Silence alarms key and Multi-function key become the function keys for the

functions on the screen which are displayed above each key.

NOTE• Defibrillation, cardioversion and pacing are not available while the

Setup screen or System Setup screen is displayed.

• Setting items on the System Setup screen and checking the hardware

must be performed by the administrator of this defibrillator at your

hospital or by a person with medical and technical knowledge.



System Setup Screen

How to Change the Itemson the System SetupScreen

Turn the Energy/Mode Select control to the SETUP position while pressing and

holding the Silence alarms key. Hold the Silence alarms key until the System Setup

– Menu screen appears.

About the System Setup - Menu screen

1. Configuration

This changes system settings.

2. Battery Test

This checks the built-in battery performance to confirm safe battery

operation.

3. HV Capacitor Test

This checks the performance of the HV (high voltage) capacitor to charge

the energy for defibrillation and cardioversion.

4. Recorder Test

This checks the built-in-recorder with preset waveforms and alphanumeric

characters.

6. System Information

This shows system information.

7. Report History

This records information for maintenance.

9. Use voce File

Play backs sound saved in an SD card.

• To select the item, press the Item key and press the OK key. The selected screen

opens.

• To exit the System Setup screen, turn he Energy/Mode Select control to any

position other than SETUP.

NOTEThe changed settings are immediately applied when they are selected.

If you want to return a setting to its previous value, set the setting again.



Configuration This changes system settings.

1. On the System Setup – Menu screen, select “1. Configuration” with the Item

key.

2. Press the OK key. The System Setup - Configuration screen appears.

You can print the hard copy of the currently displayed System Setup screen by

pressing the Record key.

2. Press the Item ↓ or Item ↑ key to select a parameter. The selected parameter is

highlighted. If the desired parameter is not on the current screen, scroll the

screen with the Item ↓ or Item ↑ key.

3. Press the Select key to select the setting. Every time the Select key is pressed,

the setting is changed.

To return to the System Setup - Menu screen, press the Menu key.



Setting List The factory default settings are underlined.

No. Parameters Description Settings

1 AED Energy

Select the 1st, 2nd and 3rd energy in AED mode. The number of charges for one sequence in AED mode is set in “5. Discharge/AED sequence”.

2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, 270 J) (Default setting: 150 for 1st, 200 for 2nd, 270 for 3rd)

2 Energy after 3rd discharge

After the third discharge, repeat the entire energy cycle (1st → 2nd → 3rd →1st…) or repeat the 3rd energy (1st → 2nd → 3rd →3rd…).

Repeat cycle, 3rd energy

3 AED button First Analysis Select whether or not to start AED analysis by pressing the CHARGE/AED button when AED mode is selected.

ON: Press the CHARGE/AED button to start AED analysis.

OFF: When AED mode is selected AED analysis is automatically started.

4 AED button 2nd or later Analysis

After each discharge, select whether manually or automatically start AED analysis.

Each shock, Each Seq., OFF

5 Discharge/AED sequence Number of discharges for one sequence in AED mode

1, 2, 3, 4

6 CPR time (s) Wait time until starting AED analysis in background after one sequence.

30, 60, 90, 120, 150, 180, 210 (s) , OFF

7 CPR timing sound Duration of CPR timing sound in AED mode

60, 70, 80, 90, 100, 110, 120 (s), OFF

8 Pause Time Pause time to temporarily pause background AED analysis in AED mode.

30, 60, 120, 180 (s)

9 Manual defib confirmation Select the confirmation method to enter manual defibrillation mode.

None, Confirm, Password

10 Password Password to enter manual defibrillation mode

Four digit password from 1, 2, 3, 4 (Default setting: 1111)

11 Charge holding time (s) Time after charging is complete until the defibrillator internally discharges

30, 40, 50, 60 (s)

12 Sync mode after CV After synchronized cardioversion, continue synchronized cardioversion mode (Sync) or return to defibrillation mode (Defib).

Sync, Defib

13 Check Pulse Pattern Select the timing of checking pulse.

1: After discharge, or after no shockable rhythm, or after CPR

2: Only after CPR 3: No checking pulse

14 ID Five digit ID number for this defibrillator. The ID number is printed on the recording paper.

Valid characters: 0 to 9, a to z, A to Z, . , - , :, space, Default setting: serial number

15 Power on lead Select lead the when the power is on. PADDLE, II 16 ECG leads Select available ECG leads. 3 LEAD, 5 LEAD

17 ECG, SpO2 sweep speed ECG and SpO2 waveform sweep speed on the screen

25, 50 (mm/s)

18 CO2 sweep speed (mm/s) CO2 waveform sweep speed on the screen 6.25, 12.5 (mm/s)



No. Parameters Description Settings

19 Alarm Setting Select the alarm settings when the power is on.

Latest, Default

20 Alarm sound Vital alarm sound type Cont tone, Beeping 21 Alarm Volume Alarm sound volume. 1, 2, 3, 4 22 Charge Sound Volume Charge sound volume. 1, 2, 3, 4 23 Voice Prompt Volume Voice prompt volume. 1, 2, 3, 4, OFF

24 Delayed recording Select whether or not to perform delayed recording.

ON, OFF

25 Alarm recording Select whether or not to perform automatic recording on vital alarm occurrence

ON, OFF

26 Record on charging after discharge

Select whether or not to perform automatic recording when energy charging starts

ON (6 s), ON (12 s), OFF

27 Record CAL wave Select whether or not to record the CAL waveform in manual recording.

ON, OFF

28 Paper speed (mm/s) Paper speed of the recorder 25, 50 (mm/s)

29 Periodic recording interval (min)

Select the interval when periodic recording is set to FREE.

1 to 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 (min)

30 Printing character size Character size printed on the recording paper

Large, Small

31 Data format Date format

YYYY/MM/DD MMM/DD/YYYY YYYY/MMM/DD DD/MM/YYYY

32 Medication Select whether or not to display the medication function keys when the Event key is pressed.

ON, OFF

33 AC line frequency AC line frequency. This setting is important to reduce artifact in SpO2

measurement. 50, 60 (Hz)

34 TEST lead Select whether or not TEST lead can be selected.

ON, OFF

35 Pressure units Units used in CO2 measurement mmHg, kPa

36 Pacing Current Steps Select the step to increase or decrease the pacing current.

1, 2, 5, 10 (mA)

37 Pacing Power on Settings Select the pacing current and pacing rate settings when the power is on.

Default, Latest

38 --- --- ---

39 Load Settings Select “ON” to load the system setup settings and setup settings from the SD card.

OK, OFF

40 Save Settings Select “ON” to save the system setup settings and setup settings in the SD card. OK, OFF

41 Format Card Select “ON” to format the SD card. OK, OFF

42 System initialize Initializes all System Setup settings. OK, OFF



Setting Description

The factory default settings are underlined.

1. AED Energy

Select the first, second and third energy in AED mode. The selected energy is

automatically charged when a shockable waveform is detected. The number of

discharges for one sequence in AED mode is set in “5. Discharge/AED

sequence” .

Selection list: 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, 270 J

2. Energy after 3rd discharge

Select the energy after the third discharge in AED mode.

Repeat cycle: The first energy is selected.

3rd energy: The third energy is selected

Repeat cycle:

After third discharge, the energies of the first, second and third discharge are

repeated.

(Example)

1st: 150 J

2nd: 200 J

3rd: 270 J

4th 150 J (same as the 1st energy)

5th: 200 J (same as the 2nd energy)

6th: 270 J (same as the 3rd energy)

7th: 150 J (same as the 1st energy)

:

3rd energy:

The energy after the 3rd discharge is the same as the energy of the 3rd

discharge.

(Example)

1st: 150 J

2nd: 200 J

3rd: 270 J





:

3. AED button First Analysis

When AED mode is selected, select whether or not to start AED analysis

(shockable waveform detection) by pressing the CHARGE/AED button.

ON: Press the CHARGE/AED button to start AED analysis in AED mode.

OFF: When AED mode is selected, AED analysis is automatically started.



4. AED button 2nd or later Analysis

After each discharge or sequence, select whether to manually or automatically

start AED analysis.

Each Shock: Press the CHARGE/AED button to start AED analysis after each

discharge.

Each Seq: Press the CHARGE/AED button to start AED analysis after each

sequence.

OFF: AED analysis is automatically started after each discharge or

after each sequence.

5. Discharge/AED sequence

Select the number of discharges for one sequence in AED mode.

Selection list: 1, 2, 3, 4

6. CPR time (s)

Select the wait time until starting AED analysis in background after one

sequence.

Selection list: 30, 60, 90, 120, 150, 180, 210 seconds, OFF

7. CPR timing sound

Select the duration of the CPR timing sound in AED mode.

Selection list: 60, 70, 80, 90, 100, 110, 120 seconds, OFF

8. Pause time

Select the pause time to temporarily pause background AED analysis in AED

mode. In AED mode, the Multi-function key changes to the Pause function

key.

Selection list: 30, 60, 120, 180 seconds and OFF

9. Manual defib confirmation

Select the confirmation method to enter manual defibrillation mode from AED

mode.

None: When the Energy/Mode Select control is set to an energy value

position, the defibrillator enters manual defibrillation mode.

This is useful when the operators are physicians.

Confirm: When the Energy/Mode Select control is set to an energy value

position, the confirmation key appears.

Press the “OK” key to enter manual defibrillation mode. This is

useful when the operators are not physicians.

Password: When the Energy/Mode Select control is set to an energy value

position, the password key appears. Enter the four digit password

to enter manual defibrillation mode. This is useful when you

want to specify the operator.

10. Password

Set the password to enter manual defibrillation mode from AED mode. This

password is necessary when “Manual defib confirmation” is set to “Password”.

Make the four digit password by from the 1, 2, 3 and 4 keys (Default setting:

1111).



11. Charge holding time (s)

Select the time after charging is complete until the defibrillator discharges the

charged energy internally.

Selection list: 30, 40, 50, 60, seconds

12. Sync mode after CV

After synchronized cardioversion, selects whether synchronized cardioversion

mode is continued or it is swithed to defibrillation mode.

Defib: After synchronized cardioversion, it automatically switches to

defibrillation mode. After one external discharge with the SYNC

button pressed, the defibrillator switches to asynchronous

defibrillation mode.

Sync: After synchronized cardioversion, the defibrillator remains in

synchronized cardioversion mode. Synchronized cardioversion

mode lasts until the SYNC button is pressed again.

13. Check Pulse Pattern

Select the timing of checking pulse.

1: After discharge, or after no shockable rhythm, or after CPR

2: Only after CPR

3: No checking pulse

14. ID

Set a five digit ID number. The ID number is printed on the recording paper.To select the digit you want to change, press the Item ↓ or Item ↑ key.

To select a number and letter, press the Select key. It changes in the order: “0”,

“1”, … ”9”, “a”, “b”, … “z”, “A”, “B”,… “Z”, “-“, “:”, “.”, “(space) ”.

When the defibrillator is shipped from the factory, the ID number is set to the

serial number.

15. Power on lead

Select the lead when the defibrillator power is turned on.

PADDLE: Displays ECG waveform from external paddles, internal paddles

or disposable pads.

II: Displays ECG waveform in II lead from ECG disposable

electrodes.

16. ECG leads

Select available ECG leads.

3 LEAD: I, II and III leads are available

5 LEAD: I, II, III, aVR, aVL, aVF, V leads are available.

17. ECG, SpO2 sweep speed (mm/s)*

Select the ECG, SpO2 waveform sweep speed on the screen.

Selection list: 25, 50 mm/s (Normally select 25 mm/s.)

18. CO2 sweep speed (mm/s)*

Select the CO2 waveform sweep speed on the screen.

Selection list: 6.25, 12.5 mm/s (Normally select 12.5 mm/s.)

* The optional QI-552V DSI interfaceunit or QI-553V DSI/AUXOUTinterface unit is necessary for SpO2

or CO2 measurement.



19. Alarm Setting

Select the alarm settings when the power is turned on.

Latest: Use the alarm settings from the previous use. This is useful where

you want usually use settings other than the default settings, for

example, in a pediatric department.

Default: Alarm settings are set to the default settings. This is useful when you

the one defibrillator for many kinds of patients.

20. Alarm sound

Select the vital alarm sound type.

Cont tone: The alarm sounds continuously.

Beeping: The alarm sounds for 3 seconds every 30 seconds.

21. Alarm Volume

Select the alarm sound volume.


22. Charge Sound Volume

Select the charge sound volume.


23. Voice Prompt Volume

Select the voice prompt volume.

Selection list: 1, 2, 3, 4, OFF

24. Delayed recording

Select whether or not to perform delayed recording.

ON: Records the waveform 4 seconds before the Record key is pressed.

OFF: Records the same waveform as that displayed on the screen.

25. Alarm recording

Selects whether or not to perform automatic recording on vital upper/lower

alarm occurrence.

Selection list: ON, OFF

26. Record on charging after discharge

Selects whether or not to perform automatic recording when energy charging

starts.

ON (6 s), ON (12 s): Automatic recording starts when energy charging starts,

and the recording stops 6 or 12 seconds after external

discharge. If the charge holding time ends after the energy

is fully charged, recording stops automatically.

OFF: Automatic recording does not start when energy charging

starts.

27. Record CAL wave

Selects whether or not to record a CAL waveform at the beginning of

recording.




28. Paper speed (mm/s)

Select the paper speed of the recorder.

25: Paper feeds 25 mm per second. Usually this setting is selected.

50: Paper feeds 50 mm per second. Suitable for a patient with rapid heart

rate.

29. Periodic recording interval (min)

Select the interval of periodic recording. This setting is available when

“Periodic Rec” on the Recorder Setup screen is set to “FREE”.

Selection list: 1 to 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

30. Printing character size

Select the character size printed on the recording paper.

Large: Prints large size characters.

Small: Prints small size characters.

31. Data format

Select the date format printed on the recording paper.

YYYY/MM/DD: year (four digits) / month (two digits) / day (two digits)

MMM/DD/YYYY: month (three digits) / day (two digits) / year (four digits)

YYYY/MMM/DD: year (four digits) / month (three digits) / day (two digits)

DD/MM/YYYY: day (two digits) / month (two digits) / year (four digits)

32. Medication

Select whether or not to display the medication function keys (Adrenalin,

Atropine, Lidocaine, Other) when the Event key is pressed.


33. AC line frequency

Selects the AC line frequency. This setting is important to reduce artifact in

SpO2 measurement.

Settings: 50, 60 Hz

34. TEST lead

Select whether or not TEST lead can be selected.

ON: TEST lead can be selected. (displayed)

OFF: TEST lead cannot be selected. (not displayed)

35. Pressure units*

Select units used in CO2 measurement.

Selection list: mmHg, kPa

36. Pacing Current Steps (TEC-5531 series only)

Select the step to increase or decrease the pacing current with the PACING

OUTPUT Up/Down key.

Selection list: 1, 2, 5, 10 mA

* The optional QI-552V DSI interfaceunit or QI-553V DSI/AUX outinterface is necessary for CO2

measurement.



37. Pacing Power on Settings (TEC-5531 series only)

Select the pacing settings (pacing current and pacing rate) when the power is

turned on.

Default: Pacing settings are set to the default settings.

Latest: Pacing settings are set to the settings of the previous use.

39. Load Settings

Select “ON” to load the system setup settings and setup settings from the SD

card.

Selection list: OK, OFF

40. Save Settings

Select “OK” to save the system setup settings and setup settings in the SD

card.


41. Format Card

Select “OK” to format the SD card.


42. System initialize

Select “OK” to initialize the system setup settings and setup settings.


If “OK” is selected, a further message appears as below.

OK: Initialization starts.

Cancel: Cancels initialization.



System Information

Report History

Recorder Check

Battery Test

HV Capacitor Test

Refer to Section 10 “Periodical Checks - Battery Test”.

Refer to Section 10 “Periodical Checks - HV Capacitor Test”.

Refer to Section 10 “Periodical Checks - Recorder Test”.

This item displays the system information.

1. On the System Setup-Menu screen, select “System Information” by pressing

the Item key and press the OK key. The system information is displayed on the

screen.

2. Press the Menu key to return to the System Setup - Menu screen.

Information for maintenance is printed.

1. On the System Setup - Menu screen, select “Report History” with the Item key

and press the OK”. The Report History screen opens.

2. To print an error history (error code)

1) Select “Instrument report” with the Item key

2) Press the Record key. The history of the error (error code), battery test and

HV capacitor test is recorded together. For the error code, refer to the

service manual.

To print the operation history since the selected date

1) Select “Year” with the Item key and select a year with the ↓ or ↑ key.

2) Select the “Month”, “Day”, “Hour” and “Minute” in the same way.

3) Press the Record key.

To cancel printing, press the Record key.

To return to the System Setup - Menu screen, press the Menu key.



Use Voice File In the Use Voice File screen, you can play back the recorded sound and ECG

waveforms saved in the SD card.

1. On the System Setup-Menu screen, select “Use Voice File” by pressing the Item

and press the OK key. The Use Voice File screen is displayed.

2. Select the file with the ↓ or ↑ key and press the Playback key. The ECG

waveforms in the selected file are played back.

• To view the ECG waveforms beyond the border of the screen, press the ← or

→ key.

• To play back the sound, press the Playback key.

• To rewind the waveforms and sound, press the ← key

• To stop playing back, press the Stop key.

3. Press the Return key to return to the file selection list.




Setup Screen

Set the settings to fit your usage purpose.

NOTE• The changed settings are immediately applied to operation when they

are selected. If you want to return a setting to its previous value, set

the setting again.

• When the screen changes to any setup screen during recording,

recording automatically stops. Record again after exiting the setup

screen.

Setup Item List

Item Description

Sync by paddle lead Select whether or not to enable synchronized cardioversion with the PADDLE lead.

Paddle setup Heart rate alarm with paddle lead

Select whether or not to generate heart rate alarms when monitoring ECG with the PADDLE lead.

AC hum filter When set to “ON”, the hum filter automatically reduces AC interference from the ECG.

Time Constant Selects the time constant for ECG display in monitoring mode. Pacing Pulse Reject When set to “ON”, it allows correct heart rate counting when the patient

has an implanted pacemaker.

ECG setup

HR alarm Select the upper and lower limit of the heart rate alarm. Sens Select the pulse wave sensitivity SpO2 Sound When set to ON, the pitch of the sync sound changes according to SpO2

value PR alarm Select the upper and lower limit of the pulse rate alarm.

SpO2 setup

SpO2 alarm Select the upper and lower limit of the SpO2 alarm. Scale Select the scale of the CO2 waveform etCO2 alarm Select the upper and lower limit of the etCO2 alarm. RR alarm Select the upper and lower limit of the respiration rate alarm.

CO2 setup

APNEA alarm Select the upper limit of the APNEA alarm. Report Select the type of report recording. Trend Time Select the time length to be recorded in the Trend report recording. List Interval Select the measurement interval for Periodic List report recording. Report setup Delete Report? Select Yes to delete all report data saved in the instrument. When Yes is

selected, further confirmation keys appear. Press the key for “Delete” to delete all report data.

PeriodicRec Select the recording interval for the automatic periodic recording. Recorder setup RecWave Select the parameter(s) which is recorded in waveform recording, alarm

report recording, event recording and automatic recording. Year, Month, Day, Hour, Minute

Select the date and time. Date/Screen

2nd Wave Select the second waveform displayed on the trace 2. QRS Setup QRS Volume Select the QRS sync sound volume. QRS Sound Select the source of the QRS sync sound. VF/VT Alarm Select whether or not to detect VF/VT.

Alarm setup HR, PR, SpO2, etCO2, RR, APNEA

Select upper/lower limits for each parameter. (only upper limit for APNEA)



How to Change theSettings on the SetupScreen

1. Turn the Energy/Mode Select control to the SETUP position. The Setup -

Menu screen appears.

2. Press the Item ↓ or Item ↑ key to select the setup screen. The selected item is

highlighted.

Paddle Setup → ECG Setup → SpO2 Setup → CO2 Setup → ReportSetup → Recorder Setup → Date/Screen → Display Setup → SaveReport → Paddle Setup

3. Press the SET key. The selected setup screen appears.

4. Press the Item key to select the item.

5. Press the ↓ or ↑ key to set the settings.

6. Repeat steps 2 to 5 to set settings on all setup screen.

To return to the Setup - Menu screen, press the Menu key.

VF/VT :In the System Setup screen, the VF/VT detection function isautomatically turned off.



Date/Screen

Paddle Setup

ECG Setup

SpO2 Setup

CO2 Setup

Report Setup

Recorder Setup

Refer to Section 4 “Changing Paddle Settings”.

Refer to Section 6 “Changing ECG Settings”.

Refer to Section 6 “Changing SpO2 Settings”.

Refer to Section 6 “Changing CO2 Settings”.

Refer to Section 8 “Changing Report and Recorder Settings”.

Refer to Section 8 “Changing Report and Recorder Settings”.

On the Date/Screen screen, you can set the date and time and the waveform in

second trace.

Date and Time

Set the defibrillator date and time.

NOTEAfter performing the basic checks, make sure that the date and time

printed on the recording paper is correct. The date and time on the

recording paper are important parts of the medical record.

Setting range

Year: 1980 to 2079, Month: 1 to 12, Day: 1 to 31, Hour: 0 to 23, Minute: 0 to 59



1. On the Date/Screen screen, select “Year”, “Month”, “Day”, “Hour”, or

“Minute” with the Item key.

2. Set the date and/or time with the ↓ or ↑ key.

3. Repeat steps 1 and 2 to set all parameters.

4. Press the Menu key to return to the Setup - Menu screen.

You cannot set seconds on this screen. For the most accurate time setting, look

at your local clock. Change the minute on the defibrillator and exit the Date/

Screen screen when the minute changes on your local clock. The second

count is set to 0 when you exit the Date/Screen screen after changing the

minute.

2nd Wave

Set the waveform in the second trace.

1. On the Date/Screen screen, select “2nd Wave” with the Item key.

2. Select the waveform displayed in the second trace with the ↓ or ↑ key.


Refer to Section 6 “Changing ECG Settings” and “Changing SpO2 Settings”

Refer to Section 7 “Setting Alarm”.Alarm Setup

QRS Setup

Setting Trace Acquired parameters

ECG ECG and SpO2 ECG and CO2 ECG, SpO2 and CO2

OFF First trace ECG ECG ECG ECG Second trace --- --- --- --- Bar graph None SpO2 CO2 SpO2 and CO2

Cascade First trace ECG ECG ECG ECG Second trace Cascaded ECG Cascaded ECG Cascaded ECG Cascaded ECG Bar graph None SpO2 CO2 SpO2 and CO2

SpO2 First trace ECG ECG ECG ECG Second trace --- SpO2 --- SpO2 Bar graph None --- CO2 CO2

CO2 First trace ECG ECG ECG ECG Second trace --- --- CO2 CO2 Bar graph None SpO2 --- SpO2

SpO2/CO2 First trace ECG ECG ECG ECG Second trace --- SpO2 CO2 SpO2 Bar graph None --- --- CO2

SpO2/CO2 First trace ECG ECG ECG ECG Second trace --- SpO2 CO2 CO2 Bar graph None --- --- SpO2



Save Report The data of Alarm report recording, Defibrillation report recording, VF Analysis

report recording and Event report recording are saved in memory. These data can

be saved in a memery card (SD card). The waveform and its information are saved.

1. On the Setup Menu screen, select “Save Report” and press the SET key. The

Save Report screen appears.

The list of saved report data are displayed with the latest one at the top. The

selected report data is highlighted. The date includes date and time and report

type. Up to five report data are listed on one screen.

The “Insert SD CARD” message appears when a memory card is not inserted

into the card slot. When a memory card is already inserted into the card slot,

the “Wait, searching for data” message and the remaining free memory are

displayed.

2. Insert the memory card into the card slot.

The remaining free memory of the card is displayed on the screen. While the

defibrillator is checking the card, the “Wait, searching for data” message is

displayed.

When a report data on the screen has already been saved in the inserted

memory card, the file name of the report data appears beside the data.

• To select a report data you want to save, use the ↓ or ↑ key. When there is

more data than currently displayed on the screen, “ ” and “ ” marks

appear above and below the list.

• To print the selected (highlighted) report data, pressing the Record key.

• To display the preview waveform of a selected report data, press the Event

key.

• To scroll the waveform, press the ← or → key.

• To close the preview screen, press the Event key.



2. Press the Save key. The highlighted data on the Save Report screen is saved in

the card and the file name is displayed. When a preview screen is displayed,

the data of the displayed waveform is saved. During saving, the “Saving don’t

power off” message is displayed.

To return to the Setup Menu screen, press the Menu key.

NOTE• Data which has already been saved in the inserted card cannot be

saved in the same card.

• When the memory card is full, the “Not enough free memory” message

appears. In this case, insert another memory card.

Preview screen


Section 4 Defibrillation,SynchronizedCardioversion and AED

General

About Defibrillation, Synchronized Cardioversion and AED ............................................ 4.0.1

Skin-Paddle Contact Impedance .................................................................................... 4.0.2

Using the Pediatric Electrode Plate ................................................................................ 4.0.3

Changing Paddle Settings .............................................................................................. 4.0.4

Turning Synchronized Cardioversion With PADDLE Lead On/Off ........................ 4.0.4

Turning Heart Rate Alarm with PADDLE Lead On/Off .......................................... 4.0.5


Synchronized Cardioversion ........................................................................................... 4.0.6

ECG Input from Another Monitor .......................................................................... 4.0.6

ECG Input from External Paddles, Internal Paddles and Disposable Pads .......... 4.0.8

Defibrillation

Defibrillation Screen ........................................................................................................ 4.1.1

Defibrillation with External Paddles ................................................................................. 4.1.2


Procedure ............................................................................................................. 4.1.3

Defibrillation with Disposable Pads ................................................................................. 4.1.8


Procedure ............................................................................................................. 4.1.9

Defibrillation with Internal Paddles ................................................................................ 4.1.15

Important Safety Information .............................................................................. 4.1.15

Procedure ........................................................................................................... 4.1.16


Synchronized Cardioversion Screen .............................................................................. 4.2.1

Synchronized Cardioversion with External Paddles ....................................................... 4.2.2


Procedure ............................................................................................................. 4.2.3

Synchronized Cardioversion with Disposable Pads........................................................ 4.2.9

Important Safety Information ...................................................................................4.2.9

Procedure............................................................................................................. 4.2.11

Synchronized Cardioversion with Internal Paddles .......................................................... 4.2.17

Important Safety Information ................................................................................. 4.2.17

Procedure............................................................................................................. 4.2.18


AED

AED Screen .................................................................................................................... 4.3.1

Important Safety Information........................................................................................... 4.3.2

AED Flowchart ................................................................................................................ 4.3.4

Preparation for AED Mode .................................................................................... 4.3.5

AED Procedure ............................................................................................................... 4.3.6

When Nonshockable Rhythm Is Detected In AED Analysis ................................ 4.3.15

Operator's Manual TEC-5500 4.0C.1

General

About Defibrillation, Synchronized Cardioversion and AED ..............................................4.0.1

Skin-Paddle Contact Impedance ......................................................................................4.0.2

Using the Pediatric Electrode Plate ..................................................................................4.0.3

Changing Paddle Settings .................................................................................................4.0.4

Turning Synchronized Cardioversion With PADDLE Lead On/Off ............................4.0.4

Turning Heart Rate Alarm with PADDLE Lead On/Off .............................................4.0.5


Synchronized Cardioversion .............................................................................................4.0.6

ECG Input from Another Monitor ............................................................................4.0.6

ECG Input from External Paddles, Internal Paddles and Disposable Pads .............4.0.8

4.0C.2 Operator's Manual TEC-5500


4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED

Operator's Manual TEC-5500 4.0.1

About Defibrillation, Synchronized Cardioversion and AED

This section explains the procedures to perform defibrillation, synchronized

cardioversion and AED. You can use external paddles, internal paddles and

disposable pads for defibrillation and synchronized cardioversion. You can use

only disposable pads for AED.

WARNINGThe defibrillator generates high voltage. The defibrillator must only

be operated by trained and qualified medical personnel.

NOTEEven if a defibrillation or cardioversion is performed on a patient

appropriately, the patient may get skin burn.

• Defibrillation

Used for terminating fatal arrhythmias, such as ventricular fibrillation and

pulseless ventricular tachycardia. Energy is discharged asynchronously.

• Synchronized cardioversion

Used for eliminating atrial fibrillation and atrial flutter. The defibrillator detects

the patient’s ECG and energy is discharged at an appropriate timing.

• AED

The defibrillator analyzes the patient’s ECG. When the defibrillator detects a

shockable rhythm, it automatically starts charging the selected energy.

Discharging is not performed automatically.


4.0.2 Operator's Manual TEC-5500

Skin-Paddle Contact Impedance

To perform effective defibrillation or cardioversion, it is important to make the

skin-paddle contact impedance as low as possible. Recommended applied pressure

on a paddle is about 100 N (10kg, 22lb.) per paddle.

For this defibrillator, the CONTACT lamp on the STERNUM paddle indicates skin-

paddle contact impedance.

0 to 100Ω: green lamp lights

100 to 200Ω: yellow lamp lights

more than 200Ω: orange lamp lights

Place the paddles so that the green lamp lights.

If the green lamp does not light, do the following.

• Apply the contact gel on the paddles uniformly.

• Clip hair on the skin where paddles are placed.

• Press the paddles against the patient and gradually increase the pressure until the

green lamp lights.

For a patient with chest hair, old patient with skin cornification (hardening) or thin

patient, the green lamp does not light. You can discharge energy when the lamp is

yellow or orange.

WARNINGIn Case of Poor Contact

If the yellow or orange lamp lights, the defibrillator may cause serious

electric burn on the patient’s skin and poor energy discharge to the

patient. In case of an emergency, medical personnel should decide

whether to execute discharge immediately, regardless of the CONTACT

lamp display, or take action to make good contact before discharge.



Using the Pediatric Electrode Plate

The pediatric electrode plate is underneath the adult electrode plate of the external

paddle. You can also attach the optional pediatric electrode assy 44 mm dia. on the

pediatric electrode plate of the external paddle.

WARNINGPay careful attention to the selected energy when using the pediatric

electrode plates. Applying high energy with the pediatric electrode

plates can cause skin burn because the electrode plates are small.

The current density on the pediatric electrode plates is higher than the current

density on the adult electrode plates because the pediatric electrode plates are

smaller* than the adult electrode plates. This increases the possibility of electrical

burn on the electrode plate placement area. The minimum effective energy should

be set.

* The pediatric electrode plates underneath the adult electrode plates are about 1/3

the surface area of the adult electrode plates. The pediatric electrodes assy 44

mm dia. are about 1/5 the surface area of the adult electrode plates.

To remove the adult electrode plate:

1. Turn the Energy/Mode select control to the OFF position.

NOTEWhile the “Shutdown NOW” message is displayed on the screen, do not

disconnect the power cord from the defibrillator or AC outlet and do not

remove the battery pack from the defibrillator. Otherwise, the internal

data may be damaged.

2. Press the tab of the adult electrode plate to unlock the adult electrode plate.

3. Slide the adult electrode plate forward and off.



Changing Paddle Settings

Turning SynchronizedCardioversion WithPADDLE Lead On/Off

Select whether or not to allow synchronized cardioversion with the PADDLE lead.

ON: Synchronized cardioversion with PADDLE lead is available.

OFF Synchronized cardioversion with PADDLE lead is not available (Default

setting: OFF).

WARNING• Use the ECG monitoring electrodes (disposable electrodes) to monitor

the ECG waveforms. Stable ECG cannot be acquired with the PADDLE

lead because it is difficult to hold the paddles stable. Also, ECG

waveform is unstable after discharge because polarization voltage is

very high.

• Do not perform synchronized cardioversion with the PADDLE lead




NOTEFirmly connect the disposable pads to the pad adaptor until the

connector of the disposable pads clicks. If the pads are not attached

firmly or the pads are not connected to the pad adaptor, noise appears

on the ECG waveform.

1. On the Paddle Setup screen, select “Sync by paddle lead” with the Item key.

VF/VT :In the System Setup screen, the VF/VT detection function isautomatically turned off.

2. Select “ON” or “OFF” with the ↓ or ↑ key.



Turning Heart Rate Alarmwith PADDLE Lead On/Off

Select whether or not to generate heart rate alarms when monitoring ECG with the

PADDLE lead.

ON: Heart rate alarms are generated when monitoring ECG with the PADDLE

lead. For long term monitoring using disposable pads, set this to ON.

OFF : Heart rate alarms are not generated when monitoring ECG with the PADDLE

lead. When you use external paddles or internal paddles, set this to OFF

(Default setting: OFF).

1. On the Paddle Setup screen, select “Heart rate alarm with paddle lead” with the

Item key.

2. Select ON or OFF with the ↓ or ↑ key.



Using the ECG Waveforms from Another Monitor, Paddles or

Disposable Pads for Synchronized Cardioversion

You can acquire ECG waveforms for synchronized cardioversion by the following

three ways.

• From the ECG connection cable and ECG disposable electrode.

• From another monitor

• From external paddles, internal paddles or disposable pads

When the patient is already connected to a monitor, it may be possible to use the

ECG signal from the monitor, but, this is not recommended.

WARNINGIf you use the ECG signal from the monitor, before cardioversion,

check that the defibrillator discharge occurs within 60 ms of the peak

of the ECG’s R wave with a delivery checker. If this condition is not

met, the cardioversion may be ineffective or may cause ventricular

fibrillation.

CAUTIONThe external instrument must comply with the CISPR 11 Second Edition

1990-09, Group 1 and Class B standard.

NOTEWhen receiving the ECG signal from a bedside monitor, select lead II or

I on the bedside monitor.

To use ECG signal from another monitor as the synchronizing signal of

synchronized cardioversion

• Connect the defibrillator to the other instrument with the optional JC-761V

External ECG cable.

• Select “AUX” for ECG lead.

ECG Input from AnotherMonitor



Use the following procedure to check whether or not synchronized cardioversion

can be performed with the ECG signal from another instrument.

1. Connect the defibrillator to the other instrument with the optional JC-761V

External ECG cable.

2. Turn the power of the other instrument on.

3. Turn the Energy/Mode Select control to the DISARM position.

4. Select “AUX” with the ECG lead key.

5. Connect an delivery checker to the other instrument and turn the delivery

checker on to generate ECG signals.

6. Turn the Energy/Mode Select control to 50 J.

7. Press the SYNC button on the front panel.

8. Check that the “ ” mark appears on the rising slope of every QRS wave.

9. Leaving the paddles on the holders of the delivery checker, press the CHARGE

button on the APEX paddle to start charging. During charging, there is a

beeping sound, a “CHARGING” message appears, and the CHARGE lamps on

the APEX paddle.

When charging is completed, there is a continuous buzzing sound, the

“CHARGED” message appears, and the CHARGE lamps light.

JC-761V External ECG cable

Connects to output signal line

Connects to GND line

red

black

10. Simultaneously press and hold both DISCHARGE buttons on the external

paddles.



ECG Input from ExternalPaddles, Internal Paddlesand Disposable Pads

The defibrillator can perform synchronized cardioversion with the PADDLE lead.

To use ECG from external paddles, internal paddles or disposable pads for

synchronizing signal of synchronized cardioversion,

• Set the “Sync by paddle lead” on the Paddle Setup screen to ON

• Select “PADDLE” for ECG lead.

WARNINGDo not perform synchronized cardioversion with the PADDLE lead


the PADDLE lead, noise may be misrecognized as QRS and discharge

might not synchronize with the patient’s QRS.

NOTE• Place the paddles on the patient so that the whole waveform is

displayed on the screen and the T waveform is not much higher than

the QRS waveform. Otherwise, QRS cannot be recognized correctly.

• If the defibrillator miscounts the narrow width QRS, set “Pacing Pulse

Reject” to OFF on the ECG Setup screen and confirm that QRS is

correctly recognized.


Defibrillation

Defibrillation Screen .........................................................................................................4.1.1

Defibrillation with External Paddles ...................................................................................4.1.2

Important Safety Information .................................................................................4.1.2

Procedure...............................................................................................................4.1.3

Defibrillation with Disposable Pads ...................................................................................4.1.8


Procedure...............................................................................................................4.1.9

Defibrillation with Internal Paddles .................................................................................. 4.1.15

Important Safety Information ............................................................................... 4.1.15

Procedure............................................................................................................. 4.1.16



Defibrillation Screen

Screen Example

Heart rateHighlighted when it exceeds theupper or lower alarm limit.

ECG lead

QRS sync mark

Sensitivity

ECG

AC power operation

Charged energy

Number of discharges



Defibrillation with External Paddles

Important SafetyInformation WARNING

• Before defibrillation, make sure that no one is in contact with either

the patient or any metal part of any equipment or cables which

supports or is connected to the patient. Failure to follow this

warning causes serious electrical shock or injury.

• Before defibrillation, remove from the patient all electrodes, probes

and transducers from a connector that do not have a “ ” or “ ”

mark. Otherwise, the operator may receive electrical shock and the

connected instrument may be damaged.

• Before defibrillation, remove everything (electrodes, patches, etc.)

from the patient’s chest. When the defibrillator paddle directly

contacts these materials, the discharged energy may cause skin burn

to the patient.

• Before defibrillation, check that the cords and cables of the

electrodes, probes and transducers attached to the patient are

properly connected to a connector that has a “ ” or “ ” mark.

Touching the metal parts of the disconnected cords and cables may

cause electrical shock or injury by discharged energy.

• When using an ESU, use this defibrillator only in the MONITOR mode

and use the ECG electrodes for monitoring. Do not monitor ECG with

disposable pads, external paddles or internal paddles. If ECG is

monitored with pads or paddles, high frequency energy from the

ESU causes abnormal current to flow in the patient and unexpected

discharge. This may damage the defibrillator.






voltage.

• Do not perform defibrillation in a wet place. Before defibrillation,

move the patient and defibrillator to a dry place. Otherwise the

operator may get electrical shock.

• The defibrillator must only be operated by trained and qualified

medical personnel.

NOTE• Select the appropriate energy and appropriate size of the external

paddles according to the patient. Only use the paddles specified by

Nihon Kohden.

• Defibrillation is not available when any setup screen or system setup

screen is displayed. Before using the defibrillator, confirm and set

the necessary settings on the Setup screen and System Setup -

Configuration screen.



Procedure1. Check that the external paddles are connected to the defibrillator.

2. Turn the Energy/Mode Select control to the DISARM position to turn the

power on. Confirm that there is no error message on the screen. For error

messages, refer to Section 9. When operating with AC power, confirm that the

AC lamp is on.

3. Confirm that the ECG lead is set to PADDLE. If another lead is selected, select

PADDLE with the ECG lead key.

4. Confirm that the SYNC lamp is not lit. If this lamp is lit, press the SYNC

button on the front panel to turn it off.

5. Prepare the paddles

1) Remove the external paddles from their holders by grasping the handles

and lifting straight up.

2) Apply contact gel to the electrode plate surface of each paddle.

3) Gently rub the electrode plate surfaces together to evenly spread the gel.







operator.



paddles.

6. Select the energy level

Turn the Energy/Mode Select control to the desired energy position.



APEX

STERNUM

7. Place the paddles on the patient

WARNINGDo not touch the electrode plate or edge of the paddle. Failure to

follow this warning may cause serious electrical burn, shock, or other

injury.

CAUTIONIf the patient’s body is wet, thoroughly wipe the moisture off the skin


Position

1) Place the left (STERNUM) paddle on the right side of sternum and below

the clavicle.

2) Place the right (APEX) paddle on the level of fifth intercostal space and

midaxillary line. When using the paddle lead, keep the paddles steady.

NOTEDo not lean against the paddles when pressing them on the patient. A

paddle may slip and cause injury.

8. Check the ECG waveform

Confirm that the patient’s ECG has a shockable rhythm, such as ventricular

fibrillation or pulseless ventricular tachycardia.

If the patient’s ECG requires synchronized cardioversion, follow the procedure

in “Synchronized Cardioversion” in this section.



9. Charge the energy

When it is verified that the patient needs defibrillation, press the CHARGE

button on the APEX paddle or CHARGE/AED button on the front panel to start

charging.

WARNING• When charging or discharging, do not touch anything other than the






During charging, there is a beeping sound, the “CHARGING” message appears

on the screen, and the CHARGE lamp blinks.


“CHARGED” message appears on the screen, and the CHARGE lamp lights.

To change the energy level after charging is completed

Turn the Energy/Mode Select control to the desired energy position. The

defibrillator starts adjusting the energy one second after the new energy is

selected.

When defibrillation becomes unnecessary after charging is completed

Turn the Energy/Mode Select control to the DISARM position or OFF position.

The defibrillator internally discharges charged energy within 20 seconds.

The defibrillator automatically internally discharges charged energy when the

charge holding time passes. This time is selected on the System Setup -


10. Check the skin-paddle contact impedance

The skin-paddle contact impedance is indicated by the CONTACT lamp on the

STERNUM external paddle. Press the paddles against the paddle placement

area so that the green lamp lights. Refer to “Skin-Paddle Contact Impedance”

in this section.

Bad example



Bad example

11. Discharge the energy to the patient

After confirming that the CHARGE lamp is lit, simultaneously press both

DISCHARGE buttons on the paddles to discharge the energy to the patient.

WARNING• Make sure that no one is in contact with either the patient or any

equipment which supports or is connected to the patient.











the heart.

CAUTIONDo not discharge when the paddles touch each other. This may


12. If another defibrillation is required, perform necessary medical treatment and

repeat steps 5 to 11.

Use the edge around each paddle holder to temporarily hold the paddles so that

contact gel does not get on the defibrillator. These holders can only be used for

the adult electrode plates.

DISCHARGE button

DISCHARGE button



13. Turn the power off

Turn the Energy/Mode Select control to the OFF position to turn the

defibrillator power off.





Thoroughly wipe off the contact gel from the external paddles and defibrillator.

Refer to “Cleaning, Disinfecting and Sterilization” in Section 10.

Put the external paddles on the paddle holders by pressing the paddles onto the

holders.



Defibrillation with Disposable Pads


• Before defibrillation, make sure that no one is in contact with either











to the patient.

















voltage.


medical personnel.



heart.



them.


package.


package.





Procedure












the heart.





patient.

NOTE• Follow all disposable pad labeling instructions.

• Always prepare the second set of disposable pads before

defibrillation. Use the second set of disposable pads if the gel of the

first set of disposable pads is dry, deteriorated or changes color.

• Before attaching the disposable pads to the patient, clean the skin

where the pads will be attached. If the skin is moist, use a cotton

swab to dry it.

• Only use the pads specified by Nihon Kohden.

• Defibrillation is not available when any Setup screen or System Setup

screen is displayed. Before using the defibrillator, confirm and set the

necessary settings on the Setup screen and System Setup -


1. Connect the pad adaptor to the defibrillator.

1) Press the paddle release knob of the paddle connector on the front panel

and remove the external paddles from the paddle connector..



CAUTIONWhen connecting the pad adapter to the paddle connector, do not


the pads.




AC lamp is on.

3. Confirm that the ECG lead is set to PADDLE. If another lead is selected, select

PADDLE with the ECG lead key.



5. Prepare the disposable pads.

1) To allow firm pad contact with the skin, clean the patient’s chest to remove

oil and dirt, and thoroughly dry the skin. Clip excessive hair, if necessary.

NOTEDo not apply any gel or paste when using disposable pads.

2) Take the disposable pads out of the package and carefully remove the

protective liner from one pad at a time.

2) Connect the pad adaptor to the paddle connector until it clicks.

3) Attach the pads to the patient’s body, one at a time.



Apex-Posterior placement

Apex-Anterior placement

RA: Right side of sternum and below the clavicle

LL: On the level of fifth intercostal space and midaxillary line

RA: Between right scapula and spine




burn.






NOTEWhen the skin-pad contact is poor, it causes high electrode impedance

and energy cannot be charged.



NOTE• Firmly connect the disposable pads to the pad adaptor until the

connector of the disposable pads clicks.

• When the “Change disposable pads” message appears, the pads may

be faulty. Replace them with new ones. If the message still appears,

stop using the defibrillator and use a different defibrillator.









When it is verified that the patient needs defibrillation, press the CHARGE/

AED button on the front panel to start charging.

WARNING• During charging or discharging, do not touch the pads or connectors.





NOTE• If the CHARGE/AED button is pressed when a disposable pad is

detached from the patient, charging does not start.

• If a disposable pad is detached during or after charging, the

defibrillator automatically discharges energy internally within 20

seconds.

4) Connect the disposable pads to the pad adaptor.




“CHARGED” message appears on the screen, and the DISCHARGE lamp

blinks.


on the screen.




selected.





charge holding time has passed. This time is selected on the System Setup -



After confirming that the DISCHARGE lamp blinks, press the DISCHARGE

button on the front panel to discharge the energy to the patient.

WARNING• Before discharging, confirm that the pads are firmly applied to the






• Make sure that no one is in contact with either the patient or any







Turn the Energy/Mode Select control to the OFF position.





Press the paddle release knob of the paddle connector to the right and remove

the pad adaptor from the paddle connector. Hold the connector part to

disconnect the pad adaptor. Otherwise the connector gets damaged and the

cable breaks.

Dispose of the disposable pads. Refer to “Cleaning, Disinfecting and

Sterilization” in Section 10.



Defibrillation with Internal Paddles

Important SafetyInformation

By directly applying the internal paddles to the heart, defibrillation during open chest

operation is available.

WARNING• Before defibrillation, make sure that no one is in contact with either the

patient or any metal part of any equipment or cables which supports or is

connected to the patient. Failure to follow this warning causes serious

electrical shock or injury.

• Before defibrillation, remove from the patient all electrodes, probes and

transducers from a connector that do not have a “ ” or “ ” mark.

Otherwise, the operator may receive electrical shock and the connected

instrument may be damaged.

• Before defibrillation, remove everything (electrodes, patches, etc.) from the

patient’s chest. When the defibrillator paddle directly contacts these

materials, the discharged energy may cause skin burn to the patient.

• Before defibrillation, check that the cords and cables of the electrodes,

probes and transducers attached to the patient are properly connected to a

connector that has a “ ” or “ ” mark. Touching the metal parts of the

disconnected cords and cables may cause electrical shock or injury by

discharged energy.

• When using an ESU, use this defibrillator only in the MONITOR mode and

use the ECG electrodes for monitoring. Do not monitor ECG with disposable

pads, external paddles or internal paddles. If ECG is monitored with pads

or paddles, high frequency energy from the ESU causes abnormal current to

flow in the patient and unexpected discharge. This may damage the

defibrillator.

• Use the ECG monitoring electrodes (disposable electrodes) to monitor the

ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead

because it is difficult to hold the paddles stable. ECG acquired from

external paddles, internal paddles or disposable pads is unstable after

discharge because of high polarization voltage.

• The defibrillator must only be operated by trained and qualified medical

personnel.

• Sterilize the internal paddles before use. Failure to sterilize the paddles

may cause serious infection.

• Pay careful attention to the energy selection when using internal paddles.

Applying high energy to the heart may cause cardiac muscle necrosis. Low

energy is recommended.

• Do not perform defibrillation in a wet place. Before defibrillation, move the

patient and defibrillator to a dry place. Otherwise the operator may get

electrical shock.



Procedure It is reported that the cardiac muscle may necrose if high energy is repeatedly

applied to the heart with internal paddles. Refer to “Reference” in Section 11.

1. Connect the internal paddles to the defibrillator.

1) Press the paddle release knob of the paddle connector to the right and

remove the external paddles from the paddle connector.

CAUTIONDo not twist the internal paddle while holding the electrode or give


NOTE• Select the appropriate energy and appropriate size of the internal


Nihon Kohden.

• Defibrillation is not available when any Setup screen or System

Setup screen is displayed. Before using the defibrillator, confirm

and set the necessary settings on the Setup screen and System

Setup - Configuration screen.

2) Connect the internal paddles to the paddle connector until it clicks.

CAUTIONDo not bend or damage the connector pins of the paddle connector.

Energy cannot be fully discharged if pins are bent or damaged.



When the internal paddles are used, 50 J or below can be selected. If above 50

J is selected, the “Set energy to 50 J or less” message appears on the screen and

the selected energy cannot be charged.


When it is verified that the patient needs defibrillation, press the CHARGE/

AED button on the front panel to start charging.

WARNING• During charging and discharging, grip the internal paddles between



electrical shock.







AC lamp is on.



4. Position the internal paddles

Position the sterilized internal paddles against the right and the left atria of the

heart.

NOTE• It is not necessary to consider the polarities of the internal paddle

electrodes.

• For better contact between the internal paddles and heart, place

sterilized gauze moistened with physiological saline solution

between each internal paddle and the heart.








guard






selected.

NOTEIf above 50 J is selected, the defibrillator immediately discharges energy

internally.








After confirming that the DISCHARGE lamp blinks, press the DISCHARGE

button on the front panel to discharge the energy to the patient. Firmly hold

the handles of the internal paddles until discharge finishes.












on the screen.



blinks.














the internal paddles from the paddle connector. Hold the connector part to

disconnect the paddle connector. Otherwise the connector gets damaged and

the cable breaks.

Wash off blood from the internal paddles and sterilize them. Refer to

“Cleaning, Disinfecting and Sterilization” in Section 10.



Synchronized Cardioversion Screen .................................................................................4.2.1

Synchronized Cardioversion with External Paddles ..........................................................4.2.2


Procedure...............................................................................................................4.2.3

Synchronized Cardioversion with Disposable Pads ..........................................................4.2.9

Important Safety Information ...................................................................................4.2.9

Procedure............................................................................................................. 4.2.11

Synchronized Cardioversion with Internal Paddles .......................................................... 4.2.17

Important Safety Information ............................................................................... 4.2.17

Procedure............................................................................................................. 4.2.18



Synchronized Cardioversion Screen

Screen Example

Heart rateECG lead

QRS sync mark

Sensitivity

ECG

AC power operation

Charged energy

SYNC mode

Synchronization point



Synchronized Cardioversion with External Paddles


• Before cardioversion, make sure that no one is in contact with either




• Before cardioversion, remove from the patient all electrodes, probes




• Before cardioversion, remove everything (electrodes, patches, etc.)



to the patient.

• Before cardioversion, check that the cords and cables of the













patient’s QRS.






voltage.

• Do not perform synchronized cardioversion with the PADDLE lead




• Do not perform cardioversion in a wet place. Before cardioversion,




medical personnel.



Procedure

CAUTIONWhen performing synchronized cardioversion, confirm that the SYNC




NOTE• Select the appropriate energy and appropriate size of the external


Nihon Kohden.

• Cardioversion is not available when any Setup screen or System

Setup screen is displayed. Before using the defibrillator, confirm and

set the necessary settings on the Setup screen and System Setup -


1. Check that the external paddles are connected to the defibrillator.




AC lamp is on.

3. Prepare the patient to monitor the ECG waveforms.

When monitoring ECG waveform with the ECG connection cable and

disposable electrodes,

1) Connect the ECG connection cable to the ECG input connector on the

front panel.

2) Attach the disposable electrodes to the patient. Refer to Section 4

“Preparing for ECG Monitoring”.

3) Clip the ECG connection cable to the electrode. Confirm that electrodes

are not pulled by the ECG connection cable.

To acquire ECG waveform from another monitor, refer to “Using the ECG

Waveforms from Another Monitor, Paddles or Disposable Pads for

Synchronized Cardioversion” in this section.

4. Press the ECG lead key to select the lead which has the highest QRS wave.

When acquiring synchronizing signal with the ECG connection cable and

disposable electrodes, usually “II” is selected. When using the ECG waveform

from another monitor, select “AUX”.

WARNINGNever select “TEST” for the ECG lead. “TEST” is for maintenance and

the waveform displayed on the screen is not the patient’s ECG. If

synchronized cardioversion is performed with the TEST lead, the

discharge is not synchronized with the patient’s QRS and it may cause

ventricular fibrillation.



NOTE• Select a lead so that the whole waveform is displayed on the screen

and the T waveform is not much higher than the QRS waveform.

Otherwise, QRS cannot be recognized correctly.




5. Select SYNC mode

1) Press the SYNC button on the front panel to select the synchronized

cardioversion mode. Confirm that the SYNC lamp lights and “SYNC” is

displayed on the screen.

2) Check that the “ ” mark appears on the rising slope of every QRS wave.

The “ ” mark indicates that the defibrillator detects the QRS wave. If the

mark does not appear, correct synchronization is not available. Do the

following to display the “ ” mark on the rising slope of every QRS wave:

- Change the amplitude of the ECG waveforms with the ECG sensitivity

key.

- Change the ECG lead with the ECG lead key.

- Change the electrode position.

NOTE• When the Energy/Mode Select control is set to MONITOR, AED,

DEMAND or FIXED position, the SYNC mode cannot be selected.

• If the Energy/Mode Select control is set to MONITOR, AED, DEMAND or

FIXED position while the SYNC mode is selected (SYNC lamp is lit),

the defibrillator exits the SYNC mode.

6. Prepare the paddles

1) Remove the external paddles from their holders by grasping the handles

and lifting straight up.

2) Apply contact gel to the electrode plate surface of each paddle.

3) Gently rub the electrode plate surfaces together to evenly spread the gel.







operator.



paddles.



APEX

STERNUM



8. Place the paddles on the patient

WARNINGDo not touch the electrode plate or edge of the paddle. Failure to

follow this warning may cause serious electrical burn, shock, or other

injury.



Position

1) Place the left (STERNUM) paddle on the right side of sternum and below

the clavicle.

2) Place the right (APEX) paddle on the level of fifth intercostal space and

midaxillary line. When using the paddle lead, keep the paddles steady.

NOTEDo not lean against the paddles when pressing them on the patient. A

paddle may slip and cause injury.




When it is verified that the patient needs synchronized cardioversion, press the

CHARGE button on the APEX paddle or CHARGE/AED button on the front

panel to start charging.

WARNING• When charging or discharging, do not touch anything other than the







on the screen.

Bad example



blinks.




selected.

When cardioversion becomes unnecessary after charging is completed






10. Check the skin-paddle contact impedance

The skin-paddle contact impedance is indicated by the CONTACT lamp on the

STERNUM external paddle. Press the paddles against the paddle placement

area so that the green lamp lights. Refer to “Skin-Paddle Contact Impedance”

in this section.



Bad example


After confirming that the DISCHARGE lamp blinks and the SYNC lamp lights,

press the DISCHARGE buttons on the paddles to discharge the energy to the

patient. Hold the buttons pressed until energy is discharged.

DISCHARGE button

DISCHARGE button






• Do not discharge near a person or object other than the patient or test

electrode plate or energy checker. This may cause electrical shock to

the person or object.





the heart.



12. If another cardioversion is required, perform necessary medical treatment and

repeat steps 5 and 7 to 11.

Use the edge around each paddle holders to temporarily hold the paddles so

that contact gel does not get on the defibrillator. These holders can only be

used for the adult electrode plate.




Turn the Energy/Mode Select control to the OFF position to turn the

defibrillator power off.





Thoroughly wipe off the contact gel from the external paddles and defibrillator.

Refer to “Cleaning, Disinfecting and Sterilization” in Section 10.

Put the external paddles to the paddle holders by pressing the paddles onto the

holders.



WARNING• Before cardioversion, make sure that no one is in contact with either











to the patient.

• Before cardioversion, check that the cords and cables of the
















voltage.



patient’s QRS.


medical personnel.



heart.



them.


package.

Synchronized Cardioversion with Disposable Pads




WARNING continued- Use the disposable pads as soon as possible after opening the

package.








• Do not cardioversion in a wet place. Before cardioversion, move the

patient and defibrillator to a dry place. Otherwise the operator may

get electrical shock.




the heart.



• When performing synchronized cardioversion, confirm that the SYNC






patient.



cardioversion. Use the second set of disposable pads if the gel of the




swab to dry it.

• Only use the pads specified by Nihon Kohden.


Setup screen is displayed. Previously confirm and set the necessary

settings on the Setup screen and System Setup-Configuration screen.



Procedure 1. Connect the pad adaptor to the defibrillator.


and remove the external paddles from the paddle connector.




the pads.




AC lamp is on.


When monitoring ECG waveforms with the ECG connection cable and



front panel.





To acquire ECG waveforms from another monitor, refer to “Using the ECG











5. Select SYNC mode









key.









When acquiring a synchronizing signal with the ECG connection cable and













burn.


















blinks.





CHARGE/AED button on the front panel to start charging.






NOTE• If the CHARGE/AED button is pressed when a disposable pad is




seconds.


on the screen.




selected.


Turn the Energy/Mode Select control to the DISARM position or OFF

position. The defibrillator internally discharges charged energy within 20

seconds.












cable breaks.







After confirming that the DISCHARGE lamp blinks and SYNC lamp lights,

press the DISCHARGE button on the front panel to discharge the energy to the

patient. Hold the buttons pressed until energy is discharged.

WARNING• Before discharging, confirm that the pads are firmly applied to the






• Make sure that no one is in contact with either the patient or any



repeat steps 5 and 7 to 9.



Synchronized Cardioversion with Internal Paddles


By directly applying the internal paddles to the heart, cardioversion during open

chest operation is available.

WARNING• Before cardioversion, make sure that no one is in contact with either


supports or is connected to the patient. Failure to follow this warning

causes serious electrical shock or injury.






from the patient’s chest. When the defibrillator paddle directly contacts

these materials, the discharged energy may cause skin burn to the

patient.

• Before cardioversion, check that the cords and cables of the electrodes,

probes and transducers attached to the patient are properly connected

to a connector that has a “ ” or “ ” mark. Touching the metal parts

of the disconnected cords and cables may cause electrical shock or

injury by discharged energy.




monitored with pads or paddles, high frequency energy from the ESU

causes abnormal current to flow in the patient and unexpected


• Use the ECG monitoring electrodes (disposable electrodes) to monitor

the ECG waveforms. Stable ECG cannot be acquired with the PADDLE

lead because it is difficult to hold the paddles stable. ECG acquired

from external paddles, internal paddles or disposable pads is unstable

after discharge because of high polarization voltage.

• Confirm that there is no artifact on the ECG. If there is artifact on the

ECG, signals other than ECG are misrecognized to be QRS and

accidental discharge may occur which is not synchronized with the

patient’s QRS wave.


personnel.

• Sterilize the internal paddles before use. Failure to sterilize the

paddles may cause serious infection.

• Pay careful attention to the energy selection when using internal paddles.

Applying high energy to the heart may cause cardiac muscle necrosis.

Low energy is recommended.



Procedure

NOTE• Select the appropriate energy and appropriate size of the internal


Nihon Kohden.


Setup screen is displayed. Before using the defibrillator, confirm and

set the necessary settings on the Setup screen and System Setup-


Synchronized cardioversion should be performed with the minimum effective

energy. It is reported that the cardiac muscle may necrose if high energy is

repeatedly applied to the heart with internal paddles. Refer to “Reference” in

Section 11.

1. Connect the internal paddles to the defibrillator.

1) Press the paddle release knob of the paddle connector to the right and

remove the external paddles from the paddle connector.

Warning - continued

• Do not perform cardioversion in a wet place. Before cardioversion,



CAUTION• Do not twist the internal paddle while holding the electrode or give


• When performing synchronized cardioversion, confirm that the SYNC







When monitoring ECG waveform with the ECG connection cable and



front panel.





2) Connect the internal paddles to the paddle connector until it clicks.



the pads.




AC lamp is on.

To acquire ECG waveform from another monitor, refer to “Using the ECG




When acquiring a synchronizing signal with the ECG connection cable and
















5. Select SYNC mode









key.










guard



When the internal paddles are used, 50 J or below can be selected. If above 50

J is selected, the “Set energy to 50 J or less” message appears on the screen and

the selected energy cannot be charged.



CHARGE/AED button on the front panel to start charging.

WARNING• During charging and discharging, grip the internal paddles between



electrical shock.

• Do not carry or move the defibrillator with the charged energy

remaining in the defibrillator. If the defibrillator falls down, it

discharges energy and can cause electrical shock.

6. Position the internal paddles

Position the sterilized internal paddles against the right and the left atria of the

heart.

NOTE• It is not necessary to consider the polarities of the internal paddle

electrodes.

• For better contact between the internal paddles and heart, place

sterilized gauze moistened with physiological saline solution

between each internal paddle and the heart.




on the screen.



blinks.




selected.

NOTEIf above 50 J is selected, the defibrillator immediately discharges energy

internally.








After confirming that the DISCHARGE lamp blinks and SYNC lamp lights,

press the DISCHARGE button on the front panel to discharge the energy to the

patient. Hold the buttons until energy is discharged. Firmly hold the handles

of the internal paddles until energy is discharged.








• Do not discharge near a person or object other than the patient or

test electrode plate or energy checker. This may cause electrical

shock to the person or object.














the internal paddles from the paddle connector. Hold the connector part to

disconnect the paddle connector. Otherwise the connector gets damaged and

the cable breaks.

Wash off blood from the internal paddles and sterilize them. Refer to

“Cleaning, Disinfecting and Sterilization” in Section 10.


AED

AED Screen .....................................................................................................................4.3.1

Important Safety Information ...........................................................................................4.3.2

AED Flowchart .................................................................................................................4.3.4

Preparation for AED Mode ......................................................................................4.3.5

AED Procedure ................................................................................................................4.3.6

When Nonshockable Rhythm Is Detected In AED Analysis ................................. 4.3.15



AED Screen

Screen Example

In AED mode, the defibrillator analyzes the ECG waveforms (AED analysis). When

shockable waveform (Ventricular Fibrillation and Ventricular tachycardia) is

detected, the defibrillator automatically charges the preset energy.

Heart rateECG lead

Sensitivity

ECG

Alarm off mark

AC power operation

Charged energy

AED mode

1st charge energy (currently selected energy is highlighted.)

2nd charge energy

3rd charge energy

Pause keyWhen AED mode is selected, the Multi-function key changes to the Pause key totemporarily stop AED analysis.




WARNING• Before defibrillation, make sure that no one is in contact with either















voltage.



patient’s QRS.


medical personnel.



heart.



them.


package.


package.













the heart.





patient.

NOTE• AED mode can be used for patients 8 years or older or 25 kg or more.

• Follow all disposable pad labeling instructions.


defibrillation. Use the second set of disposable pads if the gel of the




swab to dry it.

• Defibrillation is not available when any Setup screen or System Setup

screen is displayed. Before using the defibrillator, confirm and set the

necessary settings on the Setup screen and System Setup-




shockable rhythm

Defibrillation not necessary. Check ECG.Defibrillation necessary. Check ECG.

Press CHARGE/AED button.

Check pulse **

If no pulse, start CPR. **

nonshockable rhythm

Each shock or Each Seq.

OFF

Press CHARGE/AED button

Turn Energy/Mode Select control to AED

VF analysis startsAnalyzing VFStand clear

Result?

End sequence?

Charging startsCHARGING

Charging finishesCHARGED

Stand clear and press DISCHARGE buttons.

If no pulse, press AED button. **

CPR timing sound generates

Press DISCHARGE button

CPR time(s)

When set to OFF

When set to any number

AED button 2nd or later Analysis

(start analysis manually?)

AED button 2nd or later Analysis

(start analysis manually?)

AED button First Analysis

End after selected time

ON

Yes

No

OFF

Each shock

Each Seq. or OFF

*

AED Flowchart

AED

CPR

* If defibrillation becomes necessary during CPR, press the CHARGE/AED

button. Analysis immediately starts and operation proceeds from the “VF

analysis starts” step in the flowchart.

** “Check pulse”, “If no pulse, start CPR” and “If no pulse, press AED button”

messages are not displayed when the “Check Pulse Pattern” on the System

Setup screen is set to 3 (no checking pulse).

Bold: Displayed message

Italic: Settings in System Setup screen

User operation

Instrument operation



Change the following settings, if necessary. Refer to “System Setup Screen” in

Section 3. The factory default settings are underlined.

AED

• AED Energy ( 2 to 100, 150, 200, 270 J)

The first, second and third energy in each discharge/AED sequence. When a

shockable waveform is detected, the selected energy is automatically charged.

The number of discharges for one sequence is set in “Discharge/AED sequence”.

• Energy after 3rd discharge (Repeat cycle, 3rd energy)

The energy after the third discharge.

• AED button First Analysis (ON, OFF)

When AED mode is selected, select or not to start AED analysis (shockable

waveform detection) by pressing the CHARGE/ED button. If “ON” (default

setting) is selected, you must press the CHARGE/AED button to start AED

analysis.

• AED button 2nd or later Analysis (Each shock, Each Seq., OFF)

Select whether to manually or automatically start AED analysis after each

discharge or each sequence. Select “OFF” to automatically start AED analysis. If

“Each shock” or “Each Seq.” is selected, you must press the CHARGE/AED

button to start AED analysis.

• Discharge/AED sequence (2, 3, 4)

The number of discharges for one sequence.

• Pause time (30, 60, 120, 180 seconds and OFF)

In AED mode, the Multi-function key changes to the Pause key. Background

AED analysis can be temporarily paused by pressing the PAUSE key.

CPR

• CPR time (s) (30, 60, 90, 120, 150, 180, 210 seconds, OFF)

The time until starting AED analysis in background after a discharge/AED

sequence.

• CPR timing sound (60, 70, 80, 90, 100, 110, 120 seconds, OFF)

Duration of CPR timing sound.

Preparation for AED Mode



1. Confirm that the patient is unconscious and has no respiration and no pulse.

CAUTION• Before AED analysis or defibrillation, confirm that the patient is

unconscious and has no respiration and no pulse.

• The ECG of a child or a patient with an implanted pacemaker cannot

be analyzed correctly. For these patients, follow the physician’s

instruction.







the pads.

3. Turn the Energy/Mode Select control to the AED position to turn the power on.

Confirm that there is no error message on the screen. For error messages, refer

to Section 9. When operating with AC power, confirm that the AC lamp is on.

When AED mode is selected, the Multi-function key changes to the Pause key.

To temporarily pause background AED analysis, press the Pause key. The

pause time is set on the System Setup - Configuration screen. When the Pause

key is pressed, it changes to the Resume key. To start AED analysis, press the

Resume key.

AED Procedure



4. Confirm that “PADDLE” is selected for ECG lead.

NOTEIn AED mode, other ECG leads cannot be selected.



oil, moisture and dirt, and thoroughly dry the skin. Clip excessive hair, if

necessary.










burn.












connector of the disposable pads clicks. If the pads are not attached

firmly or the pads are not connected to the pad adaptor, noise

appears on the ECG waveform.




6. Confirm the selected energy values

Three selected energy values are displayed on the upper screen. The 1st energy

is selected. The selected energy is highlighted. Confirm that the energy is

proper.

To change the energy values, use the “AED Energy” setting in the System

Setup - Configuration screen. Refer to Section 3.

The following waveforms are saved in memory.

- Waveform of 10 seconds before and 12 seconds after discharge

- Waveform of 6 seconds after the CHARGE/AED button is pressed.

If you want to record any other waveform, press the Record key and print the

waveform on the recording paper. Waveform of 6 seconds after the CHARGE/

AED button is pressed can be printed as a report. For details refer to Section 8.



7. Start AED analysis.

Stop the life saving treatment such as CPR, keep the patient at rest and do not

touch or move the patient, pad adaptor and disposable pad cable. Then press

the CHARGE/AED button on the front panel. The background AED analysis

starts and the “Stand clear” message appears on the screen.

To automatically start background AED analysis, set “AED button First

Analysis” in the System Setup - Configuration screen to “OFF”.

WARNINGWhen you perform defibrillation in an ambulance, stop the car.

CAUTIONDuring AED analysis, stop life saving treatment such as CPR. Do not

touch or move the patient, pad adapter and disposable pad cable.

Correct analysis result cannot be obtained.

NOTEIf a shockable rhythm is detected after the CHARGE/AED button is

pressed, the defibrillator automatically starts charging the selected

(highlighted) energy. Therefore, take much care for handling the

CHARGE/AED button.

Waveforms of 6 seconds after the CHARGE/AED button is pressed and the

analysis result can be recorded as VF Analysis report recording. Up to 124

waveforms can be saved in memory. The oldest 31 waveforms are deleted

when you save over 124 waveforms. For details refer to Section 8.

selected energy



8. “CHARGING” message appearance

When a shockable rhythm is detected, the “Defibrillation necessary. Check

ECG” and “CHARGING” messages appear on the screen, there is a continuous

beeping sound. The defibrillator automatically charges the selected energy

(highlighted energy on the screen).






NOTE• Asystole is not judged to be a shockable rhythm and the defibrillator

does not automatically charge the energy.

• If the amplitude of a waveform is very small, the waveform may not be

judged as a shockable rhythm and automatic energy charging may not

be performed.

Automatic energy charging criteria is:

- Ventricular fibrillation with average amplitude not less than 0.1 mV,

or

- Ventricular tachycardia with pulse rate not less than 180/min

• When small amplitude ventricular fibrillation is not judged to be

shockable rhythm, follow the physician’s instruction and continue

the appropriate treatment. By continuing CPR, the amplitude of

ventricular fibrillation may become large and reanalysis may start

automatic energy charging.

• Pay attention to the change in ECG after automatic energy charging

starts.

• If the CHARGE/AED button is pressed when a disposable pad is




seconds.



9. “CHARGED” message appearance

When charging is completed, there is a continuous buzzing sound, the “Stand

clear and press DISCHARGE button” and “CHARGED” messages appear on

the screen, and the DISCHARGE lamp blinks.


To quit defibrillation, turn the Energy/Mode Select control to the DISARM

position or OFF position to internally discharge the charged energy.

After charging is complete, if nonshockable rhythm is detected, the

defibrillator automatically discharges the charged energy internally. For the

nonshockable rhythm, refer to “When Nonshockable Rhythm Is Detected In

AED Analysis” in this section.

The time until internal discharge is set at “Charge holding time” on the

System Setup - Configuration screen.









Confirm that the DISCHARGE lamp blinks. Then press the DISCHARGE

button on the front panel to discharge the energy to the patient.

WARNING• Before defibrillation, make sure that no one is in contact with either











to the patient.




















NOTEFirmly press the DISCHARGE button.

After defibrillation, the defibrillator returns to the condition of before AED

analysis starts. The selected energy switches to the next energy. The next

energy is highlighted on the upper screen.



11. Start AED analysis for the second discharge.

The defibrillator automatically starts reanalysis (when “AED button 2nd or

later analysis” is set to “Each Seq.” (default setting) or “OFF” on the System

Setup - Configuration screen).

When the analysis result is shockable rhythm, the defibrillator starts charging

the 2nd energy. Follow steps 8 to 10 and discharge the energy to the patient.

When the analysis result is nonshockable rhythm, refer to “When

Nonshockable Rhythm Is Detected In AED Analysis” in this section.

12. Start AED analysis for the third discharge.

The defibrillator automatically starts reanalysis (when “AED button 2nd or

later analysis” is set to “Each Seq.” (default setting) or “OFF” on the System

Setup - Configuration screen).

When the analysis result is shockable rhythm, the defibrillator starts charging

the 3rd energy. Follow steps 8 to 10 and discharge the energy to the patient.

When the analysis result is nonshockable rhythm, refer to “When

Nonshockable Rhythm Is Detected In AED Analysis” in this section.

13. After three sets of analysis (when “Discharge/AED sequence” (number of

discharges for one sequence) is set to “3” (default setting) on the System Setup

- Configuration screen), charging and defibrillation are performed and the

defibrillation failed, do necessary treatments such as CPR. The CPR timing

sound occurs according to the setting value at the “CPR timing sound” on the

System Setup - Configuration screen.

During CPR, to temporarily pause background AED analysis, press the Pause

key. When the Pause key is pressed, it changes to the Resume key. To start

backgrond AED analysis, press the Resume key. The CPR timing sound stops.

NOTEWhen defibrillation becomes necessary during CPR, press the CHARGE/

AED button to immediately start analysis.

14. If the patient needs defibrillation after CPR, repeat the steps from 7. On the

System Setup - Configuration screen, you can select two types of energy

selection after the 3rd defibrillation. Refer to Section 3.












cable breaks.





When NonshockableRhythm Is Detected In AEDAnalysis

In AED analysis, nonshockable rhythm is detected in the following cases.

• Asystole

• Ventricular fibrillation with average amplitude less than 0.1 mV

• Ventricular tachycardia with pulse rate less than 180/min

With the above analysis result, energy is not charged automatically. Perform

appropriate treatment according to emergency life saving protocol. If the patient

condition changes, perform AED analysis again and follow the physician’s

instruction.

NOTE• If the amplitude of a waveform is very small, the waveform may not be

judged as a shockable rhythm and automatic energy charging may not

be performed.

Automatic energy charging standard is:

- Ventricular fibrillation with average amplitude not less than 0.1 mV,

or

- Ventricular tachycardia with pulse rate not less than 180/min

• When small amplitude ventricular fibrillation is not judged to be a

shockable rhythm, follow the physician’s instruction and continue

the appropriate treatment. By continuing CPR, the amplitude of

ventricular fibrillation may become large and reanalysis may start

automatic energy charging.


Section 5 Pacing

About Pacing.......................................................................................................................5.1

Important Safety Information ................................................................................................5.2

Pacing in FIXED mode .........................................................................................................5.3

Information on the Pacing Screen in FIXED Mode .....................................................5.3

Procedure..................................................................................................................5.4

Pacing in DEMAND mode ................................................................................................. 5.11

Information on the Pacing Screen in DEMAND Mode .............................................. 5.11

Procedure................................................................................................................ 5.12

5. PACING (TEC-5531 Series Only)


About Pacing

Noninvasive fixed and demand pacing is only available with TEC-5531 series

defibrillators. After defibrillation, if bradycardia is observed, immediate electric

stimulation can be given through the patient’s chest with the disposable pads. The

ECG waveforms during pacing can be monitored continuously with the ECG

connection cable and disposable electrodes.

Two pacing modes are provided with the TEC-5531 series defibrillators.

FIXED mode: Pacing current is output at the selected pacing rate.

DEMAND mode: When there is no spontaneous heart beat, pacing current is

output at the selected pacing rate. When there is a

spontaneous heart beat and the next heart beat does not occur,

pacing current is output at the selected pacing rate.




WARNING• Do not perform pacing while using an ESU. Before using the ESU, turn the

defibrillator power off and remove disposable pads from the patient.

Otherwise, high frequency energy from the ESU causes abnormal current to

flow into the patient and causes electrical burn, shock or other injury. It also

damages the defibrillator.

• Always monitor the ECG waveform with the ECG connection cable and ECG

electrodes.


personnel.

• Confirm that there is no noise on the ECG. Noise may be misrecognized as

QRS and discharge might not synchronize with the patient’s QRS.

• Failure to follow the warnings below may cause skin burn or insufficient

energy discharge and insufficient pacing current to the heart.


- If the pad package is torn, dispose of the pads and do not use them.

- Do not use the pads if they are past the expiration date on the package.

- Use the disposable pads as soon as possible after opening the package.

- Do not use the disposable pads if the gel has become dry or if the gel has

become abnormal (the gel has become liquid or is coming off the edges of

the pad, etc).

- Do not use the disposable pads if the gel is dark brown or dark brown gel is

on the protective sheet.

• If any pad or connector gets wet, replace it with a new one. If a wet pad or

connector is used, it may cause electrical shock.

• When using the disposable pads for long term pacing, replace them every

hour. Failure to follow this warning may cause skin burn or insufficient

energy discharge and pacing current to the heart.

CAUTION• When using the disposable pads for long term ECG monitoring, replace them

every 24 hours. Failure to follow this instruction may cause insufficient

pacing current and insufficient energy discharge to the heart.

• Check that the pacing pulse is effective by observing ECG on the screen.

• Do not attach a disposable pad over another pad. It may cause skin burn on

the patient.

• Do not put heavy objects on the disposable pads or bend the pads. If the

pads get damaged or deteriorated, it may cause skin burn on the patient.

NOTEFollow all disposable pad labeling instructions.



Pacing in FIXED mode

Information on the PacingScreen in FIXED Mode

The following information can be displayed on the pacing screen in FIXED mode.

Pacing pulse output point

QRS sync mark

Heart rate

Fixed pacing mode

Pacing ratepacing current

ECG sensitivity

ECG lead AC power operation

ECG waveform

This is the pacing screen in FIXED mode which appears when neither SpO2 nor

CO2 are monitored.









the pads.

2. Turn the Energy/Mode Select control to the FIXED position to turn the power

on. Confirm that the “Fixed” message appears and there is no error message on

the screen and. For error messages, refer to Section 9.

3. Prepare the patient to monitor the ECG waveforms with the defibrillator.


front panel.

2) Attach the disposable ECG monitoring electrodes to the patient. Refer to

Section 6 “Preparing for ECG Monitoring”.

NOTE• Do not attach the ECG monitoring electrodes where the disposable

pads will be attached.

• If the disposable pads and ECG monitoring electrodes are placed near

each other, noise by pacing pulse becomes large and ECG cannot be

observed. If the noise is large, change the ECG electrode position and

ECG lead.



Procedure




Usually “II” is selected.




discharge is not synchronized with the patient’s QRS.







5. Select the pacing rate with the PACING RATE Up/Down key. The selected rate

appears at the lower right corner of the screen.

WARNINGThe pacing rate must be determined by qualified medical personnel


6. Select 0 mA with the PACING OUTPUT Up/Down key. Confirm that the

FIXED mode is selected.


WARNING• Failure to follow the warnings below may cause skin burn or


heart.



them.


package.


package.











the heart.





patient.

NOTE• Always prepare the second set of disposable pads before pacing. Use

the second set of disposable pads if the gel of the first set of

disposable pads is dry, deteriorated or changes color.



swab to dry it.






WARNING - continued








Anterior-Apex placement




WARNINGFailure to follow the following warnings causes serious skin burn.

• Do not attach the pads over ECG electrode.

• Do not attach pads on the papilla or medicine on the patient’s body.


through the pad. This reduces the required pacing current and pain

and discomfort to the patient.





Anterior-Posterior placement

RA: Between left scapula and spine

LL: Fifth middle axial line

WARNINGThe anterior-posterior placement is not suitable for ECG monitoring or

AED analysis. Use this placement only for pacing.




WARNINGThe apex-posterior placement is not suitable for ECG monitoring or

AED analysis.



9. Gradually increase the pacing current with the PACING OUTPUT Up/Down

key. The pacing current appears at the lower right corner of the screen. When a

pacing pulse is output, the PULSE lamp lights and a “ ” mark appears below

the ECG waveforms.

WARNING• Do not touch the patient, pads or connectors during pacing. It may

cause electrical shock.




personnel decision.

• Keep the current intensity as low as possible to minimize pain and


CAUTIONCheck that the pacing pulse is effective by observing ECG on the

screen.







8. Press the START/STOP key to start pacing. The ”Now Pacing” message

appears.



NOTE• When the pacing intensity is set to 0 mA, the PULSE lamp does not

light.

• Pacing is not performed for 3 seconds after the START/STOP key is

pressed.

• When the pacing intensity is set to under 10 mA, the “Pacing

stopped. (paddle disconnected)” message may not be displayed.

Always check the pacing effect on the screen.

To stop pacing, press the START/STOP key or select 0 mA with the PACING

OUTPUT Up/Down key.

NOTEWhen you stop pacing by selecting 0 mA with the PACING OUTPUT Up/

Down key, pacing restarts when you select another intensity with the

PACING OUTPUT Up/Down key.

10. Turn the Energy/Mode Select control to the OFF position. Press the paddle

release knob of the paddle connector on the front panel and remove the pad

adaptor from the paddle connector. Dispose of the disposable pads and the

electrodes too.







Pacing in DEMAND mode

Information on the PacingScreen in DEMAND Mode

Pacing pulse output point

QRS sync markHeart rate

Demand pacing mode

Pacing rate

Pacing current

ECG sensitivity

ECG lead

AC power operation

QRS wave detection point

Spontaneous ECG

The following information can be displayed on the pacing screen in DEMAND

mode.

This is the pacing screen in DEMAND mode which appears when neither SpO2 nor

CO2 is monitored.



WARNINGConfirm that there is no noise on the ECG. Noise may be


patient’s QRS.


1) Press the paddle release knob of the paddle connector on the right panel





the pads.

2. Turn the Energy/Mode Select control to the DEMAND position to turn the

power on. Confirm that the “Demand” appears and that there is no error

message on the screen. For error messages, refer to Section 9.

3. Prepare the patient to monitor the ECG waveforms with the defibrillator.


front panel.

2) Attach the disposable ECG monitoring electrodes to the patient. Refer to

Section 6 “Preparing for ECG Monitoring”.

Procedure



NOTE• Do not attach the ECG monitoring electrodes where the disposable

pads will be attached.

• If the disposable pads and ECG monitoring electrodes are placed near

each other, noise from the pacing pulse becomes large and ECG

cannot be observed. If the noise is large, change the ECG electrode

position and ECG lead.




Usually “II” is selected.




discharge is not synchronized with the patient’s QRS.







5. Select the pacing rate with the PACING RATE Up/Down key. The selected rate

appears in the lower right corner of the screen.

WARNINGThe pacing rate must be determined by qualified medical personnel


6. Select 0 mA with the PACING OUTPUT Up/Down key. Confirm that

DEMAND mode is selected.




WARNING• Failure to follow the warnings below may cause skin burn or


heart.



them.


package.


package.














the heart.





patient.

NOTE• Always prepare the second set of disposable pads before pacing. Use

the second set of disposable pads if the gel of the first set of

disposable pads is dry, deteriorated or changes color.



swab to dry it.





Anterior-Apex placement







WARNINGFailure to follow the following warnings causes serious skin burn.

• Do not attach the pads over ECG electrode.

• Do not attach pads on the papilla or medicine on the patient’s body.


through the pad. This reduces the required pacing current and pain

and discomfort to the patient.





Anterior-Posterior placement

RA: Between left scapula and spine

LL: Fifth middle axial line




WARNINGThe anterior-posterior placement is not suitable for ECG monitoring or

AED analysis. Use this placement only for pacing.

WARNINGThe apex-posterior placement is not suitable for ECG monitoring or

AED analysis.









8. Check that the “ ” mark appears on every QRS wave.

The “ ” mark indicates that the defibrillator detects the QRS wave. If the mark

does not appear:

- Change the amplitude of the ECG waveforms with the ECG sensitivity key.



9. Press the START/STOP key to start pacing. The “Now Pacing” message

appears.

10. Gradually increase the pacing current with the PACING OUTPUT Up/Down

key until QRS by pacing appears on the screen. The pacing current appears in

the lower right corner of the screen. When a pacing pulse is output, the PULSE

lamp lights and a “ ” mark appears below the ECG waveforms.

WARNING• Do not touch the patient during pacing. Failure to follow this warning

may cause electrical shock.



• Do not change the sensitivity or ECG lead setting after pacing is

started. If one of these settings is changed, the pacing stops for 3

seconds. Failure to follow this warning may cause serious heart

attack.


personnel decision.



WARNING continued• Keep the current intensity as low as possible to minimize pain and


• No QRS wave is detected:


to 100 ppm or more.


to 90 ppm or less.

CAUTIONCheck that the pacing pulse is effective by observing ECG on the

screen.

NOTE• The paced QRS wave may not be counted correctly.

• When the pacing intensity is set to 0 mA, the PULSE lamp does not

light.

• Pacing is not performed for 3 seconds after the START/STOP key is

pressed.

• When the pacing intensity is set to under 10 mA, the “Pacing stopped.

(paddle disconnected)” message may not be displayed. Always check

the pacing effect on the screen.

To stop pacing, press the START/STOP key or select 0 mA with the PACING

OUTPUT Up/Down key.

NOTEWhen you stop pacing by selecting 0 mA with the PACING OUTPUT Up/

Down key, pacing restarts when you select another intensity with the

PACING OUTPUT Up/Down key.

11. Turn the Energy/Mode Select control to the OFF position. Press the paddle

release knob of the paddle connector on the front panel and remove the pad

adaptor from the paddle connector. Dispose of the disposable pads and the

electrodes.






Section 6 Monitoring

General .............................................................................................................................6.0.1

Displaying the Monitoring Screen ...........................................................................6.0.1

Screen Examples ...................................................................................................6.0.1

ECG Monitoring

Preparing for ECG Monitoring ...........................................................................................6.1.2

Preparation Flowchart ............................................................................................6.1.2

Selecting a Lead ....................................................................................................6.1.2

Number of Electrodes and Measuring Leads ..........................................................6.1.3

Electrode Position ..................................................................................................6.1.3

3 Electrode Leads ........................................................................................6.1.3

5 Electrode Leads ........................................................................................6.1.4

Selecting Electrodes and Lead ...............................................................................6.1.5

Types of Electrodes and Lead ......................................................................6.1.5


the Defibrillator .......................................................................................................6.1.6

Connecting the ECG Connection Cable to the Defibrillator ...........................6.1.6

Connecting the JC-762V/JC763V Connection Cable to the Defibrillator .......6.1.6

Attaching Disposable ECG Electrodes to the Patient ............................................. 6.1.7

Monitoring ECG with Disposable Pads ...................................................................6.1.8

Monitoring ECG ................................................................................................................6.1.9

ECG Information on the Monitoring Screen ............................................................6.1.9

Selecting an ECG Lead .................................................................................................. 6.1.10

Selecting ECG Sensitivity .............................................................................................. 6.1.11

AUTO ......................................................................................................... 6.1.11

Changing ECG Settings ................................................................................................. 6.1.12

Changing Settings on the ECG Setup Screen ...................................................... 6.1.12

Turning the AC Hum Filter On/Off ......................................................................... 6.1.13

Changing the Time Constant Setting .................................................................... 6.1.14

Turning Pacing Pulse Rejection On/Off ................................................................. 6.1.15

Changing Heart Rate Upper/Lower Limit ............................................................... 6.1.16

Changing Settings on the QRS Setup Screen ...................................................... 6.1.17

Changing QRS Sync Sound Volume..................................................................... 6.1.18

Changing QRS Sync Sound Source ..................................................................... 6.1.18


Turning the VF/VT Alarm On or Off ...................................................................... 6.1.19

Use with an Electrosurgical Unit ..................................................................................... 6.1.20

SpO2 monitoring

General .............................................................................................................................6.2.1

Preparing for SpO2 Monitoring ........................................................................................... 6.2.3


Selecting a Probe ................................................................................................... 6.2.3

Reusable Probes .......................................................................................... 6.2.4

Disposable Probes ....................................................................................... 6.2.5

Attaching the Probe to the Patient ......................................................................... 6.2.6

Connecting Probe to Defibrillator ............................................................................ 6.2.6

Monitoring SpO2

................................................................................................................................................................................................... 6.2.8

SpO2 Information on the Monitoring Screen ............................................................ 6.2.8

Changing SpO2 Settings ................................................................................................... 6.2.9

Changing Settings on the SpO2 Setup Screen........................................................ 6.2.9

Changing the Pulse Waveform Sensitivity ............................................................. 6.2.10

Selecting Sync Sound Pitch ................................................................................ 6.2.11

Changing the Pulse Rate Alarm Limits ................................................................ 6.2.12

Changing the SpO2 Alarm Limits .......................................................................... 6.2.13

Changing QRS Sync Sound Volume .................................................................... 6.2.13


CO2 monitoring

General .............................................................................................................................6.3.1

CO2 Sensor Kit ....................................................................................................... 6.3.3

Preparing for CO2 Monitoring ............................................................................................ 6.3.6


Connecting the CO2 Sensor Kit to the Defibrillator .................................................. 6.3.6

Monitoring CO2

...................................................................................................................................................................................................... 6.3.7

CO2 Information on the Monitoring Screen .............................................................. 6.3.7

Changing CO2 Settings..................................................................................................... 6.3.8

Changing Settings on the CO2 Setup Screen ......................................................... 6.3.8

Changing the CO2 Scale ......................................................................................... 6.3.9

Changing the etCO2 Alarm Limits ......................................................................... 6.3.10

Changing the Respiration Rate Alarm Limits ........................................................ 6.3.11

Changing the APNEA Alarm Limit ......................................................................... 6.3.12

Inspection of Measuring Accuracy .................................................................................. 6.3.13

Daily Inspection of Measuring Accuracy ............................................................... 6.3.13

Inspection of Measuring Accuracy (Precise Method) ............................................ 6.3.13

Checking Procedure ................................................................................... 6.3.14

6. MONITORING


ECG, SpO2 and CO2 can be monitored with this defibrillator. When monitoring

starts, waveforms, measurement value of each parameter and/or bar graphs for CO2

or SpO2. are displayed on the screen.

To display the monitoring screen, turn the Energy/Mode Select control to the

MONITOR position. You can select the display parameters in the Setup - Date/

Screen screen.

General

Displaying the MonitoringScreen

Screen Examples

Heart rate ECG lead

QRS sync markECG sensitivity

ECG waveform

SpO2 value

SpO2 waveform

Pulse rate

CO2 value Respiration rateCO2 bar graph

6. MONITORING


CO2 waveform

SpO2 bar graph


ECG Monitoring

Preparing for ECG Monitoring ...........................................................................................6.1.2

Preparation Flowchart ............................................................................................6.1.2

Selecting a Lead ....................................................................................................6.1.2

Number of Electrodes and Measuring Leads ..........................................................6.1.3

Electrode Position ..................................................................................................6.1.3

3 Electrode Leads ........................................................................................6.1.3

5 Electrode Leads ........................................................................................6.1.4

Selecting Electrodes and Lead ...............................................................................6.1.5

Types of Electrodes and Lead ......................................................................6.1.5


the Defibrillator .......................................................................................................6.1.6

Connecting the ECG Connection Cable to the Defibrillator ...........................6.1.6

Connecting the JC-762V/JC763V Connection Cable to the Defibrillator .......6.1.6

Attaching Disposable ECG Electrodes to the Patient ............................................. 6.1.7

Monitoring ECG with Disposable Pads ...................................................................6.1.8

Monitoring ECG ................................................................................................................6.1.9

ECG Information on the Monitoring Screen ............................................................6.1.9

Selecting an ECG Lead .................................................................................................. 6.1.10

Selecting ECG Sensitivity .............................................................................................. 6.1.11

AUTO ......................................................................................................... 6.1.11

Changing ECG Settings ................................................................................................. 6.1.12

Changing Settings on the ECG Setup Screen ...................................................... 6.1.12

Turning the AC Hum Filter On/Off ......................................................................... 6.1.13

Changing the Time Constant Setting .................................................................... 6.1.14

Turning Pacing Pulse Rejection On/Off ................................................................. 6.1.15

Changing Heart Rate Upper/Lower Limit ............................................................... 6.1.16

Changing Settings on the QRS Setup Screen ...................................................... 6.1.17

Changing QRS Sync Sound Volume..................................................................... 6.1.18


Turning the VF/VT Alarm On or Off ...................................................................... 6.1.19

Use with an Electrosurgical Unit ..................................................................................... 6.1.20

6. MONITORING


ECG is monitored by attaching disposable electrodes to the patient and connecting

to the ECG input connector on the front panel. ECG is also monitored by attaching

disposable pads to the patient and selecting PADDLE for the ECG lead. ECG

waveform and heart rate are displayed.

6. MONITORING


Preparing for ECG Monitoring

Preparation Flowchart

Selecting a Lead

P T1

QRS1

T2

QRS2

1. Select the disposable ECG electrode and ECG connection cable.

2. Connect the ECG connection cable to the ECG input connector on the

defibrillator.

3. Attach the disposable ECG electrodes to the patient and attach the ECG

connection cable to the electrodes.

4. Monitoring starts. Set necessary settings.

For handling accessories after use, refer to Section 10.

NOTEFollow the physician’s instructions for lead position when available.

Select the optimum lead according to the following guidelines:

1) Select the lead with the highest QRS wave amplitude and least difference

in amplitude compared with a VPC or pacing pulse.

0.5 ≤ QRS1/QRS2 ≤ 2

2) Select a lead with less than 0.2 mV amplitude of the P-wave. (with the

sensitivity ×1 and P amplitude is less than 2 mm on the screen)

P ≤ 0.2 mV

3) Select a lead with a T-wave amplitude which is less than one-third of the

QRS wave.

T1 ≤ 1/3QRS1, T2 ≤ 1/3QRS2

Operator's Manual TEC-5500 6.1. 3

6. MONITORING

Number of Electrodes andMeasuring Leads

Electrode Position

The leads which can be monitored differ according to the type of ECG connection

cable or electrode lead and number of electrodes used.

NOTE• When attaching ECG electrodes for synchronized cardioversion or

external pacing, avoid positions where paddles or pads are placed.

• When electrodes cannot be attached to the positions shown below

(for example because of chest operation), a relatively stable ECG

waveform can be obtained by attaching electrodes on both shoulder

joints.

3 Electrode Leads

Electrode Position

Lead Connection

Lead I Lead II Lead III

R/RA L/LA

F/LL

R/RAR/RA L/LAL/LA

F/LLF/LL

R/RA L/LA

F/LL

Symbol Lead Color (Clip Color) Electrode PositionR

RARed (Red-beige)White (White-beige) Right infraclavicular fossa

LLA

Yellow (Yellow-beige)Black (Black-beige) Left infraclavicular fossa

FLL

Green (Green-beige)Red (Red-beige)

Lowest rib on the left anterior axillaryline

Lead Features

3 electrodes I, II, III Can measure at the thoracic wall.

5 electrodesI, II, III, aVR, aVL, aVF, V(V is one of V1 to V6)

Similar to the standard 12 lead.

6. MONITORING


Standard limb leads

Monopolar limb leads

Monopolar chest leads

Lead I Lead II Lead III

aVR lead aVL lead aVF lead

V1 to V6 leads

to

R/RA

R/RA

R/RA R/RA R/RA

R/RAR/RAL/LA

L/LA

L/LAL/LAL/LA

L/LAL/LA

F/LL

F/LL

F/LLF/LL F/LL

F/LLF/LL

N(RF/RL)

N(RF/RL)

N(RF/RL) N(RF/RL) N(RF/RL)

N(RF/RL)N(RF/RL)

Lead Connection

5 Electrode Leads

Electrode PositionR/RA L/LA

N (RF/RL) F/LL

C1/V1 C2/V2

C3/V3C4/V4

C5/V5

C6/V6Symbol Lead Color (Clip Color) Electrode Position

R RA

Red (Red-beige) White (White-beige)

Right infraclavicular fossa

L LA

Yellow (Yellow-beige) Black (Black-beige)

Left infraclavicular fossa

F LL

Green (Green-beige) Red (Red-beige)

Left midclavicular line about 12-15 mm above the iliac crest or the left edge of the backbone about 12-15 mm above the iliac crest.

N (RF) N (RL)

Black (Black-beige) Green (Green-beige)

Right anterior axillary line at the same level as F.

C V

White (Brown-white) Brown (Blue-brown)

Any one of the C1 to C6 C1 (V1): Fourth intercostal space at the

right border of the sternum C2 (V2): Fourth intercostal space at the

left border of the sternum C3 (V3): Halfway between C2 (V2)

and C4 (V4) C4 (V4): Fifth intercostal space on left

midclavicular line C5 (V5): Left anterior axial line at the

horizontal level of C4 (V4) C6 (V6): Left midaxillary line at the

horizontal level of C4 (V4)

6. MONITORING


Selecting Electrodes andLead

Types of Electrodes and Lead

Select the appropriate disposable ECG electrodes and ECG connection cable or

electrode lead according to the number of electrodes (lead).

WARNINGWhen using a defibrillator together with the monitor, use Ag/AgCl

electrodes. Other types of electrodes, stainless steel in particular, will

adversely affect the ECG waveform by slowing the baseline recovery

on the monitor and result in no monitoring immediately following

defibrillation.

CAUTIONOnly use Nihon Kohden specified parts and accessories. When other

parts or accessories are used, the defibrillator heats up and may be

damaged, and monitoring stops.

No. of Electrodes Disposable

Electrodes

ECG connection cable or

Electrode Lead Connection cable

ECG connection cable BC-763V

Not necessary

3 (I, II, III)

Electrode lead BR-018P, BR-019P, BR-024P, BR-033P, BR-034P, BR-903P

JC-762V/763V connection cable Example: JC-762V

ECG connection cable BC-765V

Not necessary

5 (I, II, III, aVR, aVL, aVF, any one of the V1 to V6)

Vitrode C-150 (Recommended)

Electrode lead BR-020P, BR-021P, BR-026P

JC-762V connection cable

6. MONITORING


Attaching Disposable ECGElectrodes to the Patient

Connecting the ECGConnection Cable or theJC-762V/JC763VConnection Cable to theDefibrillator

Connecting the ECG Connection Cable to the Defibrillator

Connect the ECG connection cable to the ECG input connector on the front panel

of the defibrillator.

Connecting the JC-762V/JC763V Connection Cable to the Defibrillator

1. Connect electrode leads to the connector of the JC-762V or JC-763V

connection cable.

2. Connect the JC-762V or JC-763V connection cable to the ECG input

connector on the front panel of the defibrillator.

CAUTIONDo not reuse disposable items.

NOTE• To maintain good contact between the electrode and skin, check that

the paste of the disposable ECG electrode is not dry.

• When contact of the disposable ECG electrode becomes poor,

replace the electrode with a new one immediately. Otherwise,

contact impedance between the skin and electrode increases and the

correct ECG cannot be obtained.

• If the contact is bad before the expiration date on the package,

replace the electrode with a new one.

1. Shave excess hair. With a piece of cotton pad moistened with alcohol, clean

the patient’s skin where the electrodes should be mounted. Avoid wrinkled or

uneven skin areas. Wipe off the alcohol with a dry cotton pad.

6. MONITORING


Extra length

NOTETo obtain a stable ECG waveform rub the skin with “Skinpure” skin

preparation gel.

2. Open the disposable electrode package and take out the electrode.

3. Remove the gel cover from the electrode. Be careful not to touch the adhesive

side.

4. Attach the disposable ECG electrode to the previously cleaned skin. Avoid

wrinkled and uneven skin areas.

NOTEIf the contact becomes bad because of sweat or body movement,

replace the electrode with a new one.

5. Clip the electrode lead or ECG connection cable onto the electrode.

NOTECheck that electrodes are not pulled by the ECG connection cable or

electrode lead.

6. Fasten the electrode lead to the skin with surgical tape with an extra length of

wire between the tape and the electrode. This prevents body movement from

moving the electrode lead.

Monitoring ECG withDisposable Pads

You can monitor patient’s ECG using the disposable pads instead of ECG

monitoring electrodes. However, 3 electrode lead ECG and 5 electrode lead ECG

are not available with disposable pads.

For connecting the pad adaptor to the defibrillator, attaching the disposable pads to

the patient and attachment site, refer to Section 4.

WARNING• When using an ESU, use this defibrillator only in the MONITOR mode








heart.



them.


package.

6. MONITORING


WARNING - continued


package.











the heart.





patient.




swab to dry it.

6. MONITORING


Monitoring ECG

ECG Information on theMonitoring Screen

Heart rate

ECG waveform

Sensitivity

ECG Lead

When electrodes are attached to the patient and cables are connected properly, ECG

appears on the screen.

CAUTIONWhen the “Check ECG Electrodes” message is displayed, ECG is not

monitored properly and the ECG alarm does not function. Check the

electrode, electrode leads and connection cord, and if necessary,

replace with new ones.

QRS sync mark

6. MONITORING


Selecting an ECG Lead

Select the lead for ECG waveform. The leads which can be selected depend on the

instrument mode (defibrillation mode, AED mode, PACING mode, MONITOR

mode) and the number of electrodes used.

Press the ECG lead key to change the ECG lead. When the key is pressed, the ECG

lead changes as below.

NOTEWhen using 5 electrode leads, select 5 leads at ECG lead on the

System Setup screen.

In defibrillation or MONITOR mode

3 electrode leads: PADDLE → I → II → III → AUX* → (TEST)*** →PADDLE...

5 electrode leads: PADDLE → I → II → III → aVR → aVL → aVF → V** →AUX* → (TEST)*** → PADDLE...

In PACING mode

3 electrode leads: I → II → III → (TEST)*** → I...

5 electrode leads: I → II → III → aVR → aVL → aVF → V** → (TEST)*** →I...

In AED mode

3 electrode leads: PADDLE only

5 electrode leads: PADDLE only

* AUX displays ECG waveform from the JC-761V External ECG cable. In 5

electrode leads, AUX (external ECG input) displays the same ECG waveform

as V.

** V is one of the chest leads V1 to V6.

*** When you set “Test lead” to OFF on the System Setup screen, TEST cannot

be selected.

NOTE• With the PADDLE lead, a patient with an implanted pacemaker cannot

be monitored correctly.

• Select a lead so that the whole waveform is displayed on the screen



• When the defibrillator miscounts the narrow width QRS, set “Pacing

Pulse Reject” to OFF on the ECG Setup screen and confirm that QRS

is correctly recognized.

6. MONITORING


(For example)

AG × 2 in MONITOR mode

screen changes to defibrillation screen.

× 2 in defibrillation mode

screen changes to MONITOR mode

× 2 in MONITOR mode

(the sensitivity does not automatically return to AUTO.)

Selecting ECG Sensitivity

Select the sensitivity of the ECG waveform to be monitored. This sensitivity is

applied to the QRS detection sensitivity. For stable QRS detection, select the

sensitivity so that the amplitude of the QRS is larger than 1 cm.

Setting range: ×1/4, ×1/2, ×1 (default setting), ×2, ×4, AUTO*

* AUTO can only be selected in monitoring mode.

Press the ECG Sensitivity key on the front panel to change the ECG sensitivity.

When the key is pressed, sensitivity changes as below.

Monitor mode: ×1/4 → ×1/2 → ×1 → ×2 → ×4 → AUTO → ×1/4

Defibrillation, pacing, AED, paddle lead mode:

×1/4 → ×1/2 → ×1 → ×2 → ×4 → ×1/4

AUTO

When you select AUTO sensitivity, the appropriate sensitivity is automatically

selected. The selected sensitivity is displayed at the left upper of the screen.

NOTEAUTO sensitivity is not possible when there is noise.

QRS waveform amplitude and selected sensitivity

When AUTO is selected in MONITOR mode and the screen changes to another

screen, the sensitivity is not AUTO any more.

QRS amplitude AUTO sensitivity Display

< 5 mm 4 AG ×4 < 10 mm 2 AG ×2 < 20 mm 1 AG ×1 < 40 mm 1/2 AG ×1/2 more than 40 mm 1/4 AG ×1/4

6. MONITORING


Changing ECG Settings

Changing Settings on theECG Setup Screen

1. Turn the Energy/Mode Select control to the SETUP position. The Setup Menu

screen appears.

2. Select “ECG Setup” with the Item ↓ or Item ↑ key and press the SET key.

The ECG Setup screen appears.

The following settings can be changed for ECG monitoring.

Item Description (default settings is underlined)

AC hum filter When set to “ON”, the hum filter automatically reduces AC interference from the ECG

ON, OFF

Time Constant Set the time constant for ECG display in MONITOR mode.

3.2s, 0.32s

Pacing Pulse Reject When set to “ON”, it allows correct heart rate counting when the patient has an implanted pacemaker.

ON, OFF

HR alarm Set the upper and lower limit of the heart rate alarm.

Upper: 20 to 300, OFF (140) Lower: OFF, 15 to 295 (40)

QRS Volume Set the QRS sync sound volume. 0 to 4 (3) QRS Sound Select the source of the QRS sync

sound. ECG, SpO2

VF/VT Alarm Select whether or not to detect VF/VT. ON, OFF

6. MONITORING


Turning the AC Hum FilterOn/Off

3. Press the Item key to select the item. When you press the key, selected item

switches.

4. Press the ↓ or ↑ key to change settings. Repeat steps 3 and 4 to set all items.

5. Turn the Energy/Mode Select control to the MONITOR position to return to

the monitoring screen appears.

When “ON” is selected, the hum filter automatically reduces AC interference from

the ECG. This filter also prevents ECG baseline drift in MONITOR mode.

ON AC interference is reduced. Select ON when there is much AC interference

or when using an electrosurgical unit. (Default setting: ON)

OFF: AC interference is not reduced. Select when you want to monitor unfiltered

waveforms for example when examining a QRS change in ECG.

NOTE• The AC hum filter is fixed to ON when PADDLE is selected as an ECG

source lead.

• When the hum filter is set to ON, some QRS waveforms are distorted

greatly.

1. On the ECG Setup screen, select AC hum filter with the Item key.


6. MONITORING


Changing the TimeConstant Setting

When ECG baseline drift is large, set the Time constant to 3.2 s (Default setting:

0.32 s).

NOTE• The Time Constant is fixed to 0.32 s when PADDLE is selected as an

ECG source lead.

• The Time Constant is fixed to 3.2 s when AUX is selected as a ECG

source lead.

1. On the ECG Setup screen, select Time Constant with the Item key.

2. Select 0.32 s or 3.2 s or with the ↓ or ↑ key.

6. MONITORING


Turning Pacing PulseRejection On/Off

* Pacing failure is a state wherepacing spike is output butventricular or atrial reaction doesnot occur.

This setting selects whether or not to reject pacemaker spike counting and allow

correct heart rate counting when monitoring the patient who has an implanted

cardiac pacemaker.

ON: Reject pacemaker spike counting and allow correct heart rate counting.

Select ON when the patient has an implanted cardiac pacemaker. When the

defibrillator detects an implanted pacemaker pulse output, “ ” is displayed

below the waveform.

OFF: Pacing pulses are not detected. Select OFF when you monitor a premature

baby or infant and the defibrillator miscounts the narrow width QRS.

(Default setting: OFF)

WARNING• Keep pacemaker patients under close observation. The pacemaker

rate may be counted during cardiac arrest and certain arrhythmias.Do not rely only on heart rate alarms and the displayed heart rate.

• With the pacing pulse rejection ON, narrow width QRS of apremature baby or infant cannot be detected correctly and thedefibrillator may miscount QRS. In this case, set the pacing pulserejection to OFF.

• Turn the pacing pulse rejection to OFF when monitoring a child.With the pacing pulse rejection ON, narrow width QRS of a childcannot be detected correctly and the defibrillator may miscount

QRS.

CAUTIONTurn the pacing pulse rejection to On when monitoring a pacemakerpatient. Otherwise QRS and pacemaker spike might not be

distinguished and pacing failure might not be recognized.

NOTEPADDLE lead has low frequency characteristics. Therefore, when you

monitor a patient with an implanted pacemaker in PADDLE lead, a

pacemaker spike may be displayed like a QRS.

1. On the ECG Setup screen, select Pacing Pulse Reject with the Item key.


6. MONITORING


Set the upper and lower limit of the heart rate alarm.

Setting range:

Changing Heart RateUpper/Lower Limit

NOTEIf you increase the upper limit over 300, the upper limit becomes OFF.

If you decrease the lower limit below 15, the lower limit becomes OFF.

CAUTIONWhen the upper or lower alarm limit is turned off, there will be no heart

rate upper or lower alarm for that limit.

1. On the ECG Setup screen, select the heart rate upper limit or lower limit of the

heart rate alarm with the Item key.

The arrow in the HR bar graph indicates the current heart rate.

2. Set the upper or lower limit with the ↓ or ↑ key.

Item Range Step Default setting

Upper 20 to 300, OFF 5 140 HR (heart rate) beat/min

Lower OFF, 15 to 295 5 40

6. MONITORING


Changing Settings on theQRS Setup Screen


screen appears.

2. Select “QRS Setup” with the Item ↓ or Item ↑ key and press the SET key.

The QRS Setup screen appears.

3. Press the Item key to select the item. When you press the key, selected item

switches.


5. Turn the Energy/Mode Select control to the MONITOR position to return to

the monitoring screen appears.

6. MONITORING


The QRS sync sound volume can be set from 0 to 4 (Default setting: 3)

1. On the QRS Setup screen, select QRS Volume with the Item key.

Changing QRS SyncSound Volume

Select the QRS sync sound source from ECG or SpO2 (pulse wave) (Default

setting: ECG).

1. On the QRS Setup screen, select QRS Sound with the Item key.

Changing QRS SyncSound Source

2. Select the volume with the ↓ or ↑ key.

2. Select the QRS sync sound source with the ↓ or ↑ key.

6. MONITORING


A shockable rhythm (ventricular fibrillation and ventricular tachycardia) is detected

when the VF/VT Alarm is set to ON (Default setting: ON) in the monitor mode.

When a shockable rhythm is detected, “Check Patient” message appears on the

screen.

NOTE• When monitoring the ECG waveforms with the external paddles or

internal paddles, the VF/VT alarm is turned off.

• In AED mode, the VF/VT alarm is always turned on regardless of this

setting.

1. On the QRS Setup screen, select VF/VT Alarm with the Item key.

Turning the VF/VT AlarmOn or Off


6. MONITORING


Grounding ESUGrounding defibrillator

ESU

Bed

3 electrodes

Defibrillator

For use with an electrosurgical unit (ESU), this defibrillator has a circuit to protect

the patient from skin burn and to reduce ESU interference on the ECG waveform.

However, the effectiveness of this circuit depends on electrode position and

defibrillator setup. With an ESU, pay attention to the following points.

WARNING• When the defibrillator is used with an electrosurgical unit (ESU),

firmly attach the entire area of the ESU return plate. Otherwise, the

current from the ESU flows into the electrodes of the defibrillator,

causing electrical burn where the electrodes are attached. For

details, refer to the ESU manual.







CAUTIONInstall the defibrillator and ESU appropriately and perform

equipotential grounding. Otherwise, noise from the ESU may be

falsely recognized as QRS and ECG monitoring might not be

performed properly.

• Arrangement

Install the defibrillator as far from the ESU as possible. If possible, locate them

on opposite sides of the operating table.

• Power Supply

Noise from the ESU may interfere with the ECG signal through the AC power

line. Supply power to the defibrillator and ESU from different outlets located as

far from each other as possible. Do the equipotential grounding properly.

Use with an Electrosurgical Unit

6. MONITORING


• Measure with 3-electrode Lead

Use the minimum number of electrodes. Use new electrodes whose gel is not dry.

• Minimizing Noise

1. Select an ECG lead where the active ECG electrodes are located as far from

the incision as possible.

2. Position the + and − electrodes as close as possible.

3. Select the leads where the angle (θ) between the active electrodes and the

incision is as small as possible.

4. Set the electrosurgical return plate as close to the incision as possible.

• Monitor pulse rate by measuring SpO2. The heart rate is unstable because of an

ESU.

• Set the following items on the ECG Setup screen.

AC Hum filter: ON

Time constant: 0.32 s

Make this angle, ,small

IncisionReturn plate

As far as possible from electrode andas near as possible to incision.

6. MONITORING




SpO2 Monitoring

General .............................................................................................................................6.2.1

Preparing for SpO2 Monitoring ...........................................................................................6.2.3

Preparation Flowchart .............................................................................................6.2.3

Selecting a Probe ...................................................................................................6.2.3

Reusable Probes ..........................................................................................6.2.4

Disposable Probes .......................................................................................6.2.5

Attaching the Probe to the Patient .........................................................................6.2.6

Connecting Probe to Defibrillator ............................................................................6.2.6

Monitoring SpO2 ................................................................................................................................................................................................... 6.2.8

SpO2 Information on the Monitoring Screen ............................................................6.2.8

Changing SpO2 Settings ...................................................................................................6.2.9

Changing Settings on the SpO2 Setup Screen........................................................6.2.9

Changing the Pulse Waveform Sensitivity ............................................................. 6.2.10

Selecting Sync Sound Pitch ................................................................................ 6.2.11

Changing the Pulse Rate Alarm Limits ................................................................ 6.2.12

Changing the SpO2 Alarm Limits .......................................................................... 6.2.13

Changing QRS Sync Sound Volume .................................................................... 6.2.13


6. MONITORING


General

SpO2 is monitored by attaching a probe to the patient and connecting the SpO2

adapter cable to the SpO2/CO2 connector on the defibrillator. For proper SpO2

probe attachment and use, refer to the operator’s manual of the SpO2 probe.

WARNING• SpO2 Measurement may be incorrect in the following cases.

- When the patient’s carboxyhemoglobin or methemoglobin

increases abnormally

- When dye is injected in the blood

- When using an electrosurgical unit

- During CPR

- When measuring at a site with venous pulse

- When there is body movement

- When the pulse wave is small (insufficient peripheral circulation)











• When not monitoring SpO2, disconnect the SpO2 connection cord

from the bedside monitor. Otherwise, noise from the probe sensor

may interfere and incorrect data is displayed on the screen.

• When using probes other than the TL-201T finger probe, to avoid








• When measuring SpO2 of a patient who is in a state of shock or in

CPR (cardiopulmonary resuscitation), the acquired SpO2 data may be

incorrect due to the patient’s body movement.

• Do not use the probe during MRI examination because it may cause



6. MONITORING


CAUTION••••• For long term monitoring, check the circulation condition by



specified hours. Reffer to the operator’s manual of the plofge

••••• Do not pull or bend the probe cable, and do not put caster feet on

the probe cable. Do not immerse the probe cable in chemical

solutions or water. Failure to follow these instructions may cause

cable discontinuity, short circuit, skin burn on the patient and

incorrect measurement data. Replace any broken probe with a new

one.

••••• Turn off the power of mobile phones, small wireless devices and

other devices which produce strong electromagnetic interference

around a patient (except for devices allowed by the hospital

administrator). Radio waves from devices such as mobile phones or

small wireless devices may be mistaken as pulse waves and the

displayed data may be incorrect.

••••• Only use the specified probes. Otherwise SpO2 cannot be monitored


••••• Do not use a probe which is past the expiration date on the package.

••••• Do not use a damaged or disassembled probe. It causes incorrect


••••• The disposable probe is not sterilized. Use the disposable probe only



••••• If the attachment site is dirty with blood or bodily fluids, clean the





••••• If the skin gets irritated or redness appears on the skin from the



••••• If the probe is attached to the same limb that is used for NIBP



correct.


affected.

••••• If patient’s nail is long, cut it or attach the probe to another finger.


••••• Refer to the probe instruction manual for details.

••••• Neonatal skin is delicate. Remove the probe and tape carefully and

slowly.

••••• When removing the probe from the attachment tape, do not pull the


6. MONITORING


Preparing for SpO2 Monitoring


Selecting a Probe

1. Select the probe.

2. Connect the probe to the SpO2 adapter and connect the SpO2 adapter to the

SpO2/CO2 connector on the defibrillator.

3. Attach the probe to the patient.

4. Monitoring starts. Set necessary settings.


Select the appropriate probe according to the purpose.

WARNINGDo not use the probe during MRI examination because it may cause



CAUTION• Only use the specified probes. Otherwise SpO2 cannot be monitored


• Do not use a probe which is past the expiration date on the package.

• Do not use a damaged or disassembled probe. It causes incorrect


6. MONITORING


Reusable Probes

Model Subject (Weight) Attachment Site SpO2 adapter

Finger Probe TL-201T

Adults, children (Weight more than 20 kg)

Finger

Adults, children, infants, neonates (Weight more than 3 kg)

Finger or toe Multi-site Probe TL-220T

Neonates (Weight less than 3 kg)

Instep

JL-951T3

6. MONITORING


Disposable Probes

Sponge attachment tape

Model Subject (Weight) Attachment Site SpO2 adapter

TL-251T Adults (Weight more than 30 kg)

Finger or toe

TL-252T Children (Weight from 3 to 40 kg)

Finger or toe

TL-253T Neonates (Weight less than 3 kg)

Instep and sole

Adults (Weight more than 50 kg)

Finger TL-051S/052S Cable length TL-051S: 80 cm TL-052S: 160 cm


Instep and sole

Adults, children (Weight from 15 to 50 kg)

Finger TL-061S/062S Cable length TL-061S: 80 cm TL-062S: 160 cm

Children, infants (Weight from 3 to 15 kg)

Toe

Adults, children (Weight more than 3 kg)

Finger or toe


Instep or sole

TL-260S

Low birth weight infants (Weight less than 1 kg)

Instep or sole

JL-951T3

CAUTIONThe disposable probe is not sterilized. Use the disposable probe only



6. MONITORING


Attaching the Probe to thePatient

Connecting Probe toDefibrillator

Probe

JL-951T3 SpO2 adapter

1. Connect the probe to the sensor connector on the JL-951T3 SpO2 adapter.

2. Connect the JL-951T3 SpO2 adapter cable to the SpO2/CO2 connector on the

defibrillator.

For proper SpO2 probe attachment and use, refer to the operator’s manual of the

SpO2 probe.

WARNING• When using probes other than the TL-201T finger probe, to avoid


















6. MONITORING


CAUTION• If the attachment site is dirty with blood or bodily fluids, clean the





• For long term monitoring, check the circulation condition by



specified hours. Reffer to the operator’s manual of the plobe you

use.

• If the skin gets irritated or redness appears on the skin from the



• When the probe is attached on an appropriate site with sufficient



• If the probe is attached to the same limb that is used for NIBP



correct.


affected.

• If patient’s nail is long, cut it or attach the probe to another finger.


• Neonatal skin is delicate. Remove the probe and tape carefully and

slowly.

• When removing the probe from the attachment tape, do not pull the


• Refer to the probe instruction manual for details.

6. MONITORING


Monitoring SpO2

When the preparation is done properly, the SpO2 value and pulse waveform appear

on the screen.

CAUTION• When the probe is attached on an appropriate site with sufficient



• Alarms about a parameter do not occur until the measurement of the

parameter starts.

• When a message indicates a faulty probe or faulty SpO2 adapter,

stop monitoring and replace the probe or SpO2 adapter with a new

one.

NOTEWhen the “Searching for SpO2 pulse” message is displayed for a long

time, it means that the detected pulse is too small to measure.

Reposition the probe.

SpO2 Information on theMonitoring Screen

SpO2 bar graph SpO

2Pulse rate SpO

2 waveform

2nd wave setting (Setup screen → Date/Screen):CO2 or OFF

2nd wave setting (Setup screen → Date/Screen):SpO2, SpO2/CO2 or SpO2/CO2

Indicates that the upper orlower alarm limit is set to off.

When the SpO2 measurement is unstable, the “M” mark appears beside the SpO2 value.

6. MONITORING


Changing SpO2 Settings

Changing Settings on theSpO2 Setup Screen

The following settings can be changed for SpO2 monitoring.

2. Select “SpO2 Setup” with the Item ↓ or Item↑ key and press the SET key. The

SpO2 Setup screen appears.


screen appears.

Item Description (default settings is underlined)

Sens Set the pulse wave sensitivity AUTO, ×1/8, ×1/4, ×1/2, ×1, ×2, ×4, ×8

SpO2 Sound When set to ON, the pitch of the sync sound changes according to SpO2 value

ON, OFF

PR Set the upper and lower limit of pulse rate alarm.

Upper: 20 to 300, OFF (140) Lower: OFF, 15 to 295 (40)

SpO2 Set the upper and lower limit of the SpO2 alarm.

Upper: 51 to 100, OFF (OFF) Lower: OFF, 50 to 99 (90)

QRS Volume Set the QRS sync sound volume. 0 to 4 (3) QRS Sound Select the source of the QRS sync sound. ECG, SpO2

6. MONITORING


Changing the PulseWaveform Sensitivity

NOTEWhen an SpO2 probe is not connected to the SpO2/CO2 connector on

the defibrillator, the SpO2 setup screen is not displayed. If not

displayed, turn the Energy/Mode Select control to the MONITOR

position, confirm the SpO2 cable connection then turn the Energy/

Mode Select control to the SETUP position.

3. Press the Item key to select the item. When you press the key, the selected item

switches.


5. Turn the Energy/Mode Select control to the MONITOR position. The

monitoring screen appears.

The sensitivity determines the size of the waveform on both the screen and

recording paper.

Setting range: AUTO, ×1/8, ×1/4, ×1/2, ×1 (default setting), ×2, ×4, ×8

When you select AUTO sensitivity, the appropriate sensitivity is automatically

selected.

1. On the SpO2 Setup screen, select Sens with the Item key.

2. Select the sensitivity with the ↓ or ↑ key.

AUTO → ×1/8 → ×1/4 → ×1/2 → ×1 → ×2 → ×4 → ×8

6. MONITORING


Selecting Sync SoundPitch

When this item is set to ON, the pitch of the sync sound changes according to SpO2

value, so you can know the SpO2 change by sound. Fixed sound is produced when

only SpO2 is measured.

ON: The pitch of the sync sound changes as shown in the table below.

OFF: The pitch of the sync sound is fixed (Default setting: OFF).

When the SpO2 adapter cable is disconnected from the defibrillator, the sync sound

automatically becomes the pitch for OFF. When the SpO2 adapter cable is

connected again, the pitch returns to the previous pitch.

1. On the SpO2 Setup screen, select SpO2 Sound with the Item key.


SpO2 Tone

100% to 81% Changes in 20 steps corresponding to SpO2 value (steps of 1).

80% or less Pitch for 81%

6. MONITORING


Changing the Pulse RateAlarm Limits CAUTION

When the upper or lower alarm limit is turned off, there will be no

upper or lower pulse rate alarm for that limit.

1. On the SpO2 Setup screen, select the upper or lower value of the pulse rate

(PR) limit with the Item key.

The arrow in the PR bar graph indicates the current pulse rate.

2. Select the upper or lower limit with the ↓ or ↑ key.




Upper 20-300, OFF 5 140 PR beat/min

Lower OFF, 15-295 5 40

6. MONITORING


Changing the SpO2 AlarmLimits CAUTION

When the upper or lower alarm limit is turned off, there will be no

upper or lower SpO2 alarm for that limit.

1. On the SpO2 Setup screen, select the upper or lower SpO2 alarm limit with the

Item key.

The arrow in the SpO2 bar graph indicates the current SpO2 value.


NOTEIf you increase the upper limit over 100, the upper limit becomes OFF. If

you decrease the lower limit below 50, the lower limit becomes OFF.

Refer to “ECG-Monitoring - Changing QRS Sync Sound Volume” in Section 6.1.

Refer to “ECG-Monitoring - Changing QRS Sync Sound Source” in Section 6.1.

Changing QRS SyncSound Volume

Changing QRS SyncSound Source


Upper 51 to 100, OFF 1 OFF SpO2 %


6. MONITORING




CO2 Monitoring

General .............................................................................................................................6.3.1

CO2 Sensor Kit .......................................................................................................6.3.3

Preparing for CO2 Monitoring ............................................................................................6.3.6

Preparation Flowchart .............................................................................................6.3.6

Connecting the CO2 Sensor Kit to the Defibrillator ..................................................6.3.6

Monitoring CO2 ...................................................................................................................................................................................................... 6.3.7

CO2 Information on the Monitoring Screen ..............................................................6.3.7

Changing CO2 Settings.....................................................................................................6.3.8

Changing Settings on the CO2 Setup Screen .........................................................6.3.8

Changing the CO2 Scale .........................................................................................6.3.9

Changing the etCO2 Alarm Limits ......................................................................... 6.3.10

Changing the Respiration Rate Alarm Limits ........................................................ 6.3.11

Changing the APNEA Alarm Limit ......................................................................... 6.3.12

Inspection of Measuring Accuracy .................................................................................. 6.3.13

Daily Inspection of Measuring Accuracy ............................................................... 6.3.13

Inspection of Measuring Accuracy (Precise Method) ............................................ 6.3.13

Checking Procedure ................................................................................... 6.3.14

6. MONITORING


General

CO2 monitoring by the mainstream method is performed by connecting the TG-

901T3T or G-921T3 CO2 sensor kit to the patient’s respiration circuit and to the

SpO2/CO

2 connector on the defibrillator. For the proper CO

2 sensor attachment and

use, refer to the operator’s manual of the CO2 sensor

WARNING• When performing defibrillation or cardioversion during CO2

monitoring with the CO2 sensor kit, remove the sensor from the

patient. When the sensor cannot be removed, do not touch the

sensor cable because the discharged energy may cause serious

electrical burn, shock or other injury.

• With the TG-901T3 CO2 sensor kit, measurements are based on the

assumption of no CO2 gas in the inspiration. The CO2 concentration

in the respiration is calculated by taking the CO2 concentration in

the inspiration as 0 mmHg. Therefore, measuring CO2 by connecting

the CO2 sensor kit to a patient under mouth-to-mouth respiration or

to a Jackson Rees circuit or Mapleson D circuit where CO2 gas may

be present during inspiration may result in the acquired data being

lower than the actual value.

• With the TG-901T3 CO2 sensor kit, this monitor cannot monitor CO2 of

patients weighing less than 10 kg (22 lbs).

• Do not use the airway adapter on neonates because the dead space


• When using the YG-101T airway adapter on children or patients with



inaccurate measured values or difficulty in detecting no breath.


volume.

• Before MRI examination, remove the CO2 sensor kit from the patient.

Failure to follow this warning may cause serious electrical burn on

the patient due to local heating caused by dielectric electromotive

force. For details, refer to the MRI operator’s manual.

CAUTION• The CO2 data may be inaccurate when monitoring a patient with an

extremely high respiration rate or irregular respiration. Read the

measured values carefully.

• Measured value may be incorrect when the operating temperature

changes greatly.

• When using an anesthetic instrument with a volatile anesthetic

agent, the CO2 measurement may be inaccurate.

6. CO2 MONITORING


NOTEThe measurement may be inaccurate when the defibrillator is used in

the following conditions. Read the measured values carefully.

• When there is high concentration nitrous oxide gas in the airway

adapter.

• When used in places with low atmospheric pressure such as at high

altitude.

• When used in environments with sudden temperature changes.

• When used in environments with severe humidity.

• When used for patients with irregular spontaneous respiration.

6. MONITORING


CO2 Sensor KitWARNING

••••• Do not use the airway adapter on neonates because the dead space


••••• When using the YG-101T airway adapter on children or patients with





volume.

••••• When using the YG-121T nasal adapter on children or patients with





volume.

••••• When you use YG-122T together with an oxygen cannula, check that



••••• If arterial oxygen saturation does not increase, immediately stop

using the oxygen cannula with the CO2 sensor kit and select another

way to supply oxygen.

••••• The only oxygen cannula that can be used with YG-122T is #1103

manufactured by HUDSON RCI. Do not use any other oxygen

cannula. Other oxygen cannulas cannot be attached and oxygen

cannot be delivered to the patient through the nostrils.

••••• Check that the oxygen cannula tube is not bent, broken, or blocked

by the nasal tube. If the ends of the oxygen cannula tube turn too far

up or down, it causes insufficient oxygen supply or the CO2 value

may be incorrect.

CAUTION••••• The airway adapter/nasal adapter is non-sterilized and disposable.

Use only for a single patient and single use. Failure to follow this

instruction causes cross infection.

••••• Do not sterilize the airway adapter. Safety cannot be guaranteed if

the airway adapter is sterilized.

••••• Use the Nihon Kohden specified airway adapter.

••••• With the TG-901T3 CO2 sensor kit, secure the CO2 sensor to the





6. CO2 MONITORING


CAUTION continued••••• Failure to follow the instructions below degrades the anti-fogging


- Replace the airway adapter/nasal adapter with a new one every

24 hours.

- Replace the airway adapter/nasal adapter with a new one if

blood, sputum or mucus adhere to the transparent film.




••••• Never autoclave or perform EOG gas sterilization for the TG-901T3


guaranteed.

••••• When using the YG-121T/YG-122T nasal adapter on a patient with




••••• When using the YG-121T nasal adapter on children or patients with





volume.

••••• When you use YG-122T together with an oxygen cannula, check that



••••• With the TG-901T3 CO2 sensor kit, secure the CO2 sensor to the





••••• Failure to follow the instructions below degrades the anti-fogging


- Replace the airway adapter/nasal adapter with a new one every

24 hours.

- Replace the airway adapter/nasal adapter with a new one if

blood, sputum or mucus adhere to the transparent film.




••••• Never autoclave or perform EOG gas sterilization for the TG-901T3


guaranteed.

••••• When using the YG-121T/YG-122T nasal adapter on a patient with





6. MONITORING

TG-901T3 CO2 Sensor kit YG-101T Airway Adapter

For over 3 years old or over 10 kg

OPER/ALARM

CO2 ADAPTER


TG-101T CO2 sensor

HOPER/ALARM

CO2 ADAPTER

TG-921T3 CO2 Sensor Kit

TG-121T CO2 sensor


Nasal tube

Clip

Mouth guide

Holder for oxygen cannula

YG-120T(for nasal breathing)

YG-121T(for naso-oral)

YG-122T(for oxygen cannula)

Model Patient Weight Dead space volume Code No. YG-101T Adult 10 kg or more 5 cc R801

Description Model Q’ty Code No. Nasal adapter (for nasal breathing) YG-120T 30 V921 Nasal adapter (for naso-oral breathing) YG-121T 30 V922 Nasal adapter (for oxygen cannula adjustment) YG-122T 30 V923

6. CO2 MONITORING


Preparing for CO2 Monitoring


Connecting the CO2 SensorKit to the Defibrillator

1. Connect the CO2 sensor kit to the SpO

2/CO

2 connector on the defibrillator.

2. Connect the CO2 sensor to the respiration circuit.

3. Start measurement and change necessary settings.


Connect the CO2 sensor kit to the SpO

2/CO


6. MONITORING


Monitoring CO2

CO2 Information on theMonitoring Screen

After completing the preparation, CO2 monitoring starts.

CAUTIONWhen the “CO2 sensor not working” or “CO2 adapter abnormality”

message is displayed, check the CO2 sensor kit and replace it if

necessary. CO2 cannot be monitored while the message is displayed.

NOTE• When using the TG-901T3/TG-921T3 CO2 sensor kit, it performs

calibration automatically every minute and when any of the following

occurs.

- Defibrillator power on

- Patient’s first respiration

- Airway adapter is removed from the CO2 sensor and connected

again.

- Respiration stops for 20 seconds.

- Signal changes rapidly due to temperature change.

• During calibration, the CO2 waveform becomes flat (0 mmHg) but the

respiration rate and measured value are not affected.

2nd wave setting (Setup screen → Date/Screen):SpO2 or OFF

2nd wave setting (Setup screen → Date/Screen):CO2, SpO2/CO2 or SpO2/CO2

Respiration rate

CO2 waveformCO

2 valueCO

2 bar graph

Indicates that the upper orlower alarm limit is set to off.

6. CO2 MONITORING


Changing CO2 Settings

Changing Settings on theCO2 Setup Screen

The following settings can be changed for CO2 monitoring.


screen appears.

2. Select “CO2 Setup” with the Item ↓ or Item ↑ key and press the SET key. The

CO2 Setup screen appears.

Item Description (default settings are underlined.)

Scale Set the scale of CO2 waveform 0 to 40, 0 to 80 (mmHg) 0 to 5.3, 0 to10.7 (kPa) mmHg Upper: 2 to 99, OFF (50)

Lower: OFF, 1 to 98 (20) etCO2

Set the upper and lower limit of the CO2 alarm. kPa Upper: 1.0 to 13.5, OFF (7.0)

Lower: OFF, 0.5 to 13.0 (3.0)

RR Set the upper and lower limit of the respiration rate alarm.

Upper: 2 to 150, OFF (OFF) Lower: OFF, 0 to 148 (OFF)

APNEA Set the upper limit of the APNEA alarm. Upper: 5 to 40, OFF (OFF)

6. MONITORING


Changing the CO2 Scale

3. Press the Item key to select the item. When you press the key, the selected

item switches.

4. Press the key for “↓” or “↑” to change settings. Repeat steps 3 and 4 to set all

items.

5. Turn the Energy/Mode select control to the MONITOR position to return to the

monitoring screen appears.

Select the appropriate scale for the patient CO2 waveform.

Setting range: 0 to 40, 0-80 (default setting)

(0 to 5.3, 0-10.7 when kPa is selected)

1. On the CO2 Setup screen, select Scale with the Item key.

2. Select the scale with the ↓ or ↑ key.

6. CO2 MONITORING


Changing the etCO2 AlarmLimits

Set the upper and lower limit for the etCO2 alarm.

CAUTIONWhen the upper or lower alarm limit is turned off, there will be no

etCO2 upper or lower alarm for that limit.

1. On the CO2 Setup screen, select etCO

2 upper or lower limit with the Item key.

· The arrow in the etCO2 bar graph indicates the current etCO2 value.


NOTEIf you increase the upper limit over 99 (mmHg) or 13.5 (kPa), the upper

limit becomes OFF. If you decrease the lower limit below 1 (mmHg) or

0.5 (kPa), the lower limit becomes OFF.


Upper 2-99, OFF 1 50 mmHg


Upper 1.0 to 13.5, OFF 0.5 7.0 etCO2

kPa Lower OFF, 0.5 to 13.0 0.5 3.0

6. MONITORING


Changing the RespirationRate Alarm Limits



The arrow in the RR bar graph indicates the current respiration rate.


Set the upper and lower limit for the respiration rate alarm.

CAUTIONWhen the upper or lower alarm limit is turned off, there will be no

respiration rate upper or lower alarm for that limit.

1. On the CO2 Setup screen, select respiration rate upper or lower limit with the

Item key.


Upper 2 to 150, OFF 2 OFF RR count/min

Lower OFF, 0 to 148 2 OFF

6. CO2 MONITORING


Changing the APNEAAlarm Limit

Set the period of no respiration for the APNEA alarm. When the defibrillator

cannot detect patient respiration for more than the selected seconds, the APNEA

alarm occurs.

CAUTIONWhen the alarm limit is turned off, there will be no APNEA alarm for

that limit.

1. On the CO2 Setup screen, select APNEA with the Item key.

2. Select apnea alarm limit with the ↓ or ↑ key.



APNEA s Upper 5 to 40, OFF 5 OFF

6. MONITORING


Inspection of MeasuringAccuracy (Precise Method)

Inspection of Measuring Accuracy

Perform daily accuracy inspection using your own respiration.

Put the larger end of the airway adapter (side for connecting to the patient’s mask

and tracheal tube) into your mouth and after stabilizing breathing, breathe in the

same way as in the resting state at a rate of 5 seconds per breath (12 breaths/

minute). Breathing too quickly or taking deep breaths will disable standard

measurements.

The standard etCO2 concentration is 40 mmHg. Check that the CO

2 gas

concentration display is from 35 to 45 mmHg.

Check the measurement accuracy whenever you suspect the defibrillator is not

reading correctly. This procedure does not calibrate CO2 sensor. It only checks the

measurement accuracy. If the measurement accuracy is not appropriate, contact

your Nihon Kohden distributor.

The following parts are required.

CAUTION• Only use the specified items.

• Follow the CAUTION label on the CO2 gas cylinder.

• After the lifetime of the CO2 gas cylinder expires, the measurement

accuracy cannot be guaranteed.

• 5% CO2 calibration gas

Manufacturer: Nellcor Puritan Bennett or Scott Medical Products

Cylinder name: OD (1 L disposable cylinder)

Outlet connection: CGA 600

Gas volume: 25 L (Provides about 50 to 100 calibrations)

Gas component: 5% CO2, 21% O

2, balance N

2

Accuracy: ±0.03% absolute

Expiration: 3 years after the gas is packed in the cylinder

• Flow regulator PR-150 flow regulator (Full scale 700 psi)

Manufacturer: VICTOR High Purity & Instrumentation

Delivery flow (flow rate): 0.5 L/min

Inlet connection: CGA 600

• Tube

Internal diameter: 4 mm

Daily Inspection ofMeasuring Accuracy

6. CO2 MONITORING


• Slip joint

Manufacturer: Portex

Specification: 100/252 4 mm

When using a CO2 gas cylinder and flow regulator other than the above, the

following specifications must be met. Make sure that the outlet connection of the

gas cylinder and the inlet connection of the flow regulator fit together.

• 5% CO2 calibration gas

Gas component: 5% CO2, 21% O

2, balance N

2

Accuracy: ±0.03% absolute

• Flow regulator

Delivery flow (flow rate): 0.5 L/min

Checking Procedure

1. Connect the flow regulator to the CO2 gas cylinder by rotating the flow

regulator clockwise. Connect them firmly.

2. Connect the CO2 sensor kit to the SpO

2/CO


3. Connect the airway adapter to the CO2 sensor so that the marks on the

airway adapter and CO2 sensor align.

4. After checking that the CO2 gas cylinder is connected properly, gently turn the

knob of the flow regulator counterclockwise about half a turn to start the gas

flow.

5. Connect the slip joint to the airway adapter. CO2 gas flows in the airway

adapter and the instCO2 on the screen should read 38 mmHg. (Expiration

phase, 38 mmHg CO2 gas)

6. Disconnect the slip joint from the airway adapter and shake the CO2 sensor to

remove CO2 gas from the airway adapter. Open air flows into the airway

adapter and instCO2 on the screen should be 0 mmHg. (Inspiration phase, no

CO2 gas)

Slip jointKnob

Pressure gauge

Connect/disconnect the airway adapter repeatedly.

Pressure gauge Knob

6. MONITORING


CAUTION• This method assumes that no CO2 gas is present in the inspiration

phase of breathing. Therefore, step 6 has to be performed to

simulate the inspiration phase of breathing so that the defibrillator

can correctly determine the CO2 concentration. The defibrillator

determines the CO2 concentration by comparing the change in CO2

concentration in the airway adapter during the inspiration and

expiration phase of breathing.

• The defibrillator calculates the CO2 concentration by assuming that

the gas temperature is 37°°°°°C and the surrounding pressure is 1

atmospheric pressure. Therefore, if this checking procedure is

performed at room temperature or lower, the defibrillator will display

higher instCO2 (there will be −−−−−0.4% per °°°°°C difference).

Correspondingly, if the checking procedure is performed at high

altitude, the defibrillator will display a lower instCO2 reading (there

will be 1 mmHg/30 hPa difference).

7. Repeat steps 5 and 6 a few times and compare the readings of step 5. The

readings should be the same.

8. After checking, gently turn the flow regulator knob clockwise to stop the gas

flow.

NOTEWhen the pressure gauge of the flow regulator reads 0, replace the CO2

gas cylinder with a new one.

6. CO2 MONITORING




Section 7 Alarm Function

General .............................................................................................................................. 7.1

Alarm Types ............................................................................................................. 7.1

Alarm Indication ....................................................................................................... 7.1

Alarm List ................................................................................................................. 7.2

Alarm Status Marks and Messages ......................................................................... 7.4

Temporarily Silencing an Alarm After It Occurs ................................................................. 7.5

Silencing Alarms ...................................................................................................... 7.5

Resuming Alarms .................................................................................................... 7.5

Suspending an Alarm Before It Occurs .............................................................................. 7.6

Suspending Alarms ................................................................................................. 7.6

Automatic Alarm Recording ............................................................................................... 7.6

Setting Alarms ................................................................................................................... 7.7

Alarm Setting Range................................................................................................ 7.7

Setting Alarm Settings on the Alarm Setup Screen ................................................. 7.8

Setting Alarm Settings on the Alarm Setup Screen of the Setup Screen ................ 7.9

Setting Alarms Individually ..................................................................................... 7.10

7. ALARM FUNCTION


General

Alarm Indication

Alarm Types

Alarms let you know abnormalities of measurement environment, instrument and

measurement value of each parameter by messages on the screen and sound.

Alarms are categorized into three types.

When an alarm occurs,

• An alarm sounds.

• An alarm message appears on the screen. For a vital alarm, the measurement

value is highlighted.

• Automatic alarm recording starts. (only for vital alarms and only when the alarm

recording is set to ON.)

You can turn the alarm recording ON/OFF on the System Setup - Configuration

screen. Refer to Section 3.

Alarm Description

Instrument alarm Generated when any instrument abnormality is detected. (for example, discharged battery or out of recording paper)

Alarm for measurement environment

Generated when any abnormality is detected in measurement environment. (for example, connector off, check electrode, check probe, etc)

Vital alarm Generated when each measurement value exceeds previously set upper/lower limits.

7. ALARM FUNCTION


Alarm List

1 3

0

Type Alarm Alarm Display Alarm Sound

Battery discharged (battery remaining charge is 1/3 )

Charge battery ( )

Displayed during detection

Continuous or beeping tone*

INTERNAL DISCHARGE

Out of paper

No report data

Low impedance

High impedance

Displayed for 5 seconds For 5 seconds

Instrument Alarm (2)

Time to replace battery Displayed during detection No alarm sound


SpO2 probe not working

SpO2 module not working

CO2 adapter abnormality

CO2 sensor not working

CO2 module not working

Overheating

High voltage monitor error

Relay drive error

Insert battery

Power abnormality

Charge battery (blinking )

Replace battery

FET error

ERROR K×××

ERROR P×××

ERROR D×××

ERROR C×××

ERROR A×××

Continuous tone Instrument Alarm (1)

Set energy to 50J or less



Operator's Manual TEC-5500 7. 3

7. ALARM FUNCTION

* You can select either continuous or beeping sound on the System Setup screen.

Continuous: continuous beeping

Beeping (default setting): sounds for 3 seconds every 30 seconds

** You can silence alarm sound by pressing the Silence alarms key.


Pacing stopped (paddle disconnected)**

Pacing stopped (ECG lead disconnected) **

Continuous tone

Change disposable pads

Check disposable pads

Connect paddle



Use disposable pads Displayed for 5 seconds

Select ECG lead For 5 seconds

Select a different lead

Change ECG electrodes

Check ECG electrodes

SpO2 measurement unstable

Searching for SpO2 pulse

Check SpO2 probe site

Check SpO2 unit


SpO2 module disconnected**

CO2 module disconnected**

Continuous tone

Alarms for measurement environment

Connect AC power or Charge battery




HR alarm

PR alarm

SpO2 alarm

etCO2 alarm

RR alarm

Highlighted value

VF/VT alarm (Check Patient)

Vital alarm

APNEA


Continuous or beeping tone

7. ALARM FUNCTION


Alarm off mark:

• Displayed at every parameter for which the upper and/or lower alarm limit is set

to OFF.

• Displayed at a parameter whose alarm is silenced.

• Displayed at every parameter when all alarms are suspended.

Value:

Highlighted while the value exceeds the alarm limit.

“Alarm off” message:

• Displayed at the top of the screen when any vital alarm upper/lower limit is set to

OFF.

• When the “Alarm silenced 2 min”, “Alarm silenced 1 min”, “Alarms suspended 2

min” or “Alarms suspended 1 min” message is displayed, the “Alarm off”

message is not displayed. When the alarm silence or suspension finishes, it is

displayed again.

• Disappears when all alarm settings are set to settings other than OFF.

VF/VT alarm off mark:

• Displayed at the upper right corner of the screen.

• Displayed when VF/VT analysis is not performed.

• Displayed when “VF/VT Alarm” is set to “OFF” in Alarm Setup screen.

• Displayed when the paddle lead is selected and the external paddles or internal

paddles is connected.

• Displayed when the Setup screen, pacing screen, Basic checks screen or Alarm

Setup screen is selected.

Alarm Status Marks andMessages

7. ALARM FUNCTION


Temporarily Silencing an Alarm After It Occurs

Silencing Alarms

* Instrument Alarm (1) on the page 7.2

Resuming Alarms

When an alarm occurs, you can silence the alarm sound for two minutes.

NOTEAlarms which indicate instrument abnormalities* are not silenced by

pressing the Silence alarms key.

• When the following alarms occur, contact your Nihon Kohden

distributor or representative.

SpO2 probe not working Power abnormality

SpO2 module not working FET error

CO2 adapter abnormality ERROR K×××××××××××××××

CO2 sensor not working ERROR P×××××××××××××××

CO2 module not working ERROR D×××××××××××××××

Overheating ERROR C×××××××××××××××

High voltage monitor error ERROR A×××××××××××××××

Relay drive error

• When the following alarms occur, take a remedial action immediately,

referring to section 9.

Insert battery

Charge battery (blinking 0 mark)

Replace battery

During alarm silence,

• the alarm sound is silenced

• the “Alarm silenced 2 min” “Alarm silenced 1 min” message is displayed at the

top of the screen.

When the alarm cause is removed during alarm silence, the alarm is cleared.

Press the Silence alarms key on the front panel.

Alarms resume when:

• The cause of alarm continues after the alarm silence ends.

• The Silence alarms key is pressed during alarm silence.

• A different alarm (except for instrument alarm (2)) occurs.

• The cause of alarm disappears during alarm silence, then the same alarm occurs

again.

7. ALARM FUNCTION


Suspending an Alarm Before It Occurs

Automatic Alarm Recording

Suspending Alarms

When automatic alarm recording is set to ON, waveforms beginning 4 seconds

before and ending 8 seconds after the alarm are automatically recorded when an

alarm is generated. For details, refer to Section 8.

An alarm can also be suspended before it occurs, for example, before you replace

the electrodes. The alarm suspend time is two minutes.

During alarm suspension, all alarms are suspended and

• the alarm sound is silenced.

• The “Alarms suspended 2 min” or “Alarms suspended 1 min” message is

displayed.

Press the Silence alarms key on the front panel when no alarms are occurring.

WARNINGDuring alarm suspension (“Alarm off” or “Alarms suspended” message

displayed), all current alarms except for instrument alarm group 1 are

turned off.

7. ALARM FUNCTION


Vital alarm limits can be set in three different ways:

• Set on the Alarm Setup screen while monitoring

• Set on the Alarm Setup screen of Setup screen

• Set on each setting screen for the individual parameter of the Setup screen.

When you change an alarm setting on one screen, the same setting on another

screen is also automatically changed.

CAUTIONWhen the alarm limit is set to OFF, there will be no alarm for that

limit. Be careful when you set the alarm limit to OFF.

NOTEIf you try to set a value higher than maximum value or lower than

minimum value, the alarm becomes OFF.

For example,

HR upper/lower limit

Upper: 290 →→→→→ 295 →→→→→ 300 →→→→→ OFF

Lower: 25 →→→→→ 20 →→→→→ 15 →→→→→ OFF

Setting Alarms

Alarm Setting Range


Upper 20 to 300, OFF 5 140 HR (heart rate) beat/min


Upper 20 to 300, OFF 5 140 PR beat/min


Upper 51 to 100, OFF 1 OFF SpO2 %


Upper 2 to 99, OFF 1 50 mmHg


Upper 1.0 to 13.5, OFF 0.5 7.0 etCO2

kPa Lower OFF, 0.5 to 13.0 0.5 3.0

Upper 2 to 150, OFF 2 OFF RR count/min

Lower OFF, 0 to 148 2 OFF

APNEA s Upper 5 to 40, OFF 5 OFF

7. ALARM FUNCTION


Setting Alarm Settings onthe Alarm Setup Screen

NOTEYou can change alarm settings on the Alarm Setup screen only in the

MONITOR mode.

All vital alarms can be set on one screen. This way is useful when you are

monitoring a patient and you want to change or confirm the vital alarm settings.

1. Press the Multi-function key (Alarm Setup) on the front panel to display the

Alarm Setup screen.

2. Press the Item key to select the parameter. The left side is upper limits and

right side is lower limits. When the key is pressed and held, selected items

switch automatically.

3. Press the ↓ or ↑ key to set the upper and/or lower limit for the selected

parameter. When the key is pressed and held, the value increases or decreases

automatically.

NOTE• If you try to set a value higher than the maximum value or lower than

the minimum value, the alarm becomes OFF.

• If you try to set the lower limit to a value higher than the upper limit,

the higher limit automatically increases. If you try to set the higher

limit to a value lower than the lower limit, the lower limit

automatically decreases. The increased upper limit or decreased

lower limit does not become OFF.

4. Press the Monitor key to return to the monitoring screen.

7. ALARM FUNCTION


Setting Alarm Settings onthe Alarm Setup Screen ofthe Setup Screen

All vital alarms can be set on one screen.


screen appears.

2. Select “Alarm Setup” with the Item ↓ or Item ↑ key and press the SET key.

The Alarm Setup screen appears.

3. Press the Item key to select the parameter. When the key is pressed and held,

selected items switch automatically.

4. Press the ↓ or ↑ key to set the upper and/or lower limit for the selected

parameter. When the key is pressed and held, the value increases or decreases

automatically.








5. Turn the Energy/Mode Select control to the MONITOR position.

7. ALARM FUNCTION


You can set each vital alarm on each parameter setup screen.

Example: Setting the ECG alarm


screen appears.

Setting Alarms Individually

2. Select “ECG Setup” with the Item ↓ or Item ↑ key and press SET key. The

ECG Setup screen appears.

3. Select “HR” with the Item key. When the key is pressed and held, selected

items switch automatically.

4. Select the heart rate upper and/or lower limit with the ↓ or ↑ key. When the key

is pressed and held, the value increases or decreases automatically.








5. Turn the Energy/Mode Select control to the MONITOR position.


Section 8 Recording

About Recording ................................................................................................................ 8.1

Changing Report and Recorder Settings ........................................................................... 8.3

Manual Recording .............................................................................................................. 8.4

Real Time or Delayed Waveform Recording ............................................................ 8.4

Procedure ...................................................................................................... 8.4

Report Recording .................................................................................................... 8.5

Periodic List Report Recording ...................................................................... 8.5

Alarm Report Recording ................................................................................ 8.5

Event List Report Recording .......................................................................... 8.6

Defibrillation Report Recording ...................................................................... 8.8

VF Analysis Report Recording ...................................................................... 8.9

Trend Report Recording .............................................................................. 8.10

Event Recording ...................................................................................................... 8.11

Saving the Administered Medication ....................................................................... 8.12

Automatic Recording ......................................................................................................... 8.13

Record On Charging After Discharge....................................................................... 8.13

Alarm Recording ...................................................................................................... 8.14

Periodic Recording .................................................................................................. 8.15

Printed Letters and Marks ................................................................................................. 8.16

8. RECORDING


About Recording

Available recording types are shown on the next page.

NOTEWhen the screen changes to any setup screen during recording,

recording automatically stops. Record again after you exit the setup

screen.

For the recording examples in this section, “Printing character size” is set to

“Small” in the System Setup - Configuration screen.

8. RECORDING


* The Alarm, Defib and VF Analysis reports share memory. The length/capacity of recorded data is shown for one report

type when no data for the other two report types is saved in memory. If data of more than one report types is saved in

memory, the maximum length/capacity of recorded data for each report type decreases.

** This data is used for Alarm report recording.

*** This data is used for Defib report recording.

Recording mode Recorded data Length/Capacity of

recorded data Start/Stop Operation

(Real time or delayed) Waveform recording

Waveform on the screen Either real time or 4 seconds delayed waveform recording can be selected. (Delayed is the default setting.)

Continuous Press the Record key. To stop during recording, press the Record key.

Periodic List Periodic measurement data Up to 120 measurement data The periodic measurement interval can be selected on the Recorder Setup screen.

Alarm ECG waveforms and another parameter waveform when an alarm occurs or the Event key is pressed.

Waveforms for up to 60 alarms* (when ECG is selected at “RecWave” on the Recorder Setup screen.)

Event list Event list Up to 130 events Defib Waveform at discharge and

settings Up to 44 discharges* Waveform from 10 seconds before to 12 seconds after discharge

VF Analysis Waveforms of 6 seconds after the CHARGE/AED button is pressed and the analysis result

Up to 124 analyses*

Report recording

Trend Trend graph and numeric data 1, 2, 4, 8 or 24 hours. You can set the recorded period at “Trend Time” on the Report Setup screen.

Press the Record key when the Report Setup screen is displayed. To stop during recording, press the Record key.

Manual recording

Event recording** ECG waveform when the Event key is pressed.

Waveform from 4 seconds before to 8 seconds after the Event key is pressed.

Press the Event key. To stop during recording, press the Record key.

Record on charging after discharge***

ECG waveform before and after discharge

ECG from the start of energy charging to 6 or 12 seconds after discharge

Starts when the defibrillator starts charging energy. To stop during recording, press the Record key.

Alarm recording** ECG waveform when an alarm occurs

ECG waveform from 4 seconds before to 8 seconds after alarm occurrence.

Starts automatically. To stop recording, press the Record key.

Automatic recording

Periodic recording Periodic ECG, SpO2 and CO2 delayed waveforms

For 12 seconds The recording interval is set at “PeriodicRec” on the Recorder Setup screen.

Starts automatically. To stop recording, press the Record key.

8. RECORDING


1. Turn the Energy/Mode Select control to the SETUP position to display the

Setup Menu screen.

2. Select “Report Setup” or “Recorder Setup” with the Item ↓ or Item↑ key and

press the SET key. The Report Setup screen or Recorder Setup screen appears.

3. Select the item with the Item key.

Report Setup screen

Report: Select the type of report recording from Periodic list, Alarm,

Event list, Defib, VF analysis and Trend.

Trend Time: Select the time length to be recorded in the Trend report from

1, 2, 4, 8 and 24 hours.

List Interval: Select the measurement interval for Periodic List report from

1, 5, 15, 30 and 60 min.

Delete Report?: Select Yes to delete all report data saved in the defibrillator.

When Yes is selected, further confirmation keys appear. Press

the key for “Delete” to delete all report data.

Recorder Setup screen

PeriodicRec: Select the recording interval for the automatic periodic

recording from OFF, FREE, 15 min, 30 min, 60 min and 2 hrs.

When FREE is selected, recording is performed at the interval

set on the “Periodic recording interval (min)” on the System

Setup - Configuration screen.

RecWave Select the parameter(s) which is recorded in Waveform

recording, Alarm report recording, Event recording, Record on

charging after discharge, Alarm recording and Periodic

recording from ECG, ECG + SpO2 and ECG + CO2.

4. Select the setting value with the ↓ or ↑ key.


Changing Report and Recorder Settings

Report Setup screen Recorder Setup screen

8. RECORDING


Manual Recording

Real Time or DelayedWaveform Recording

CO2 and SpO

2 are measured.

Delayed waveform recording

MONITOR mode

ECG sensitivity ×1

SpO2 sensitivity ×1

Paper speed 25mm/s

AC filter is ON

ECG lead II

Time constant 0.32s

Recording example

The ECG waveforms can be manually recorded at any time. You can record any

length waveform with this mode. Besides ECG waveforms, ID, date, time, ECG

lead and ECG sensitivity are also recorded. ECG waveform recordings are either

real time or delayed; you can select this on the System Setup - Configuration

screen. When Delayed recording is set to ON, the waveform from 4 seconds before

the Record key is pressed is recorded.

Procedure

To start recorfding, press the Record key. During recording, the Recording

mark appears on the screen. To stop recording, press the Record key again.

8. RECORDING


Report Recording There are six kinds of report recording: Periodic list, Alarm, Event list, Defib, VF

analysis and Trend. To do report recording, you need to display the Report Setup

screen. Set the following settings on the Report Setup screen.

Periodic List Report Recording

Measurement values for each parameter at the selected interval are recorded in a

list format.

Procedure

1. Select “Periodic list” at the Report on the Report Setup screen. Refer to

“Changing Report and Recorder Settings” in this section.

2. Press the Record key. The Report recording mark appears on the screen.

The recording stops when all data are recorded.

To stop recording, press the Record key again.

You can select the measurement interval at List Interval on the Report Setup screen.

The data for the Periodic list report recording remains in memory after the power

off.

Alarm Report Recording

ECG waveform and either SpO2 or CO2 waveform when the Event key is pressed or

when an alarm occurs is recorded. The recorded data are the same as that of the

Event recording and automatic alarm recording.

Procedure

1. Select “Alarm” at the Report on the Report Setup screen. Refer to “Changing

Report and Recorder Settings” in this section.



To stop during recording, press the Record key again.

The data for the Alarm report recording remains in memory after the power off.

• Waveforms for up to 60 alarms are saved when ECG is selected at RecWave on

the Recorder Setup screen. After waveforms for 60 alarms are saved, when

another alarm occurs, the waveform for that alarm is saved and the oldest 15

waveforms are deleted.

• Waveforms for up to 48 alarms are saved when ECG and SpO2 are selected at

RecWave on the Recorder Setup screen. After waveforms for 48 alarms are

saved, when another alarm occurs, the waveform for that alarm is saved and the

oldest 12 waveforms are deleted.

• Waveforms for up to 56 alarms are saved when ECG and CO2 are selected at

RecWave on the Recorder Setup screen. After waveforms for 56 alarms are

saved, when another alarm occurs, the waveform for that alarm is saved and the

oldest 14 waveforms are deleted.

8. RECORDING


Event List Report Recording

The list of defibrillator usage history with clock time are recorded in a

chronological order. This is useful for an operation diary or defibrillator operation

history.

Procedure

1. Select “Event list” at the Report on the Report Setup screen. Refer to





The data for the Event list report recording remains in memory after the power is

turned off.

Up to 10 events are recorded on one column. Up to 130 events are recorded. After

130 event data are saved, when the defibrillator detects another event, the oldest

data is deleted.

Recording examples

(1) When the Event key is pressed

(2) When an alarm occurs

Recording example

8. RECORDING


Recorded Events

Event Meaning

Power ON The power is turned on. Power OFF The power is turned off. Charging Charging for discharge is started. Charged Charging for discharge is completed. Discharge XXX J Defibrillation is performed at XXX J. Sync XXX J Synchronized cardioversion is performed at XXX J. VF analysis start CHARGE/AED button is pressed in AED mode. Shockable The defibrillator detected a shockable rhythm after the CHARGE/AED

button was pressed in AED mode. No Shockable The defibrillator did not detect a shockable rhythm after the CHARGE/AED

button was pressed in AED mode. Check Patient The defibrillator detects a shockable rhythm. Disarm The energy discharges internally within 20 seconds after charging. Alarm HR *XXX Heart rate alarm occurs at XXX bpm. Alarm PR *XXX Pulse rate alarm occurs at XXX. Alarm SpO2 *XXX SpO2 alarm occurs at XXX. Alarm RR *XXX Respiration rate alarm occurs at XXX. Alarm etCO2 *XXX mmHg etCO2 alarm occurs at XXX mmHg. Alarm etCO2 *XXX kPa etCO2 alarm occurs at XXX kPa. Alarm Apnea *XXX s Apnea alarm occurs at XXX seconds. Event The Event key is pressed. ECG electrode off A disposable electrode is detached from the patient. ECG electrode set A disposable electrode is attached to the patient. Dispo pads off The pad adaptor is disconnected from the defibrillator, or the disposable pad

is detached from the patient. Dispo pads set The pad adaptor is connected to the defibrillator, or the disposable pad is

attached to the patient. Fixed mode start (XXXppm, XXXmA)

The Fixed pacing mode (pacing rate XXX pulse/min and pacing current is XXX mA) is started.

Demand mode start (XXXppm, XXXmA)

The Demand pacing mode (pacing rate XXX pulse/min and pacing current is XXX mA) is started.

Pacer stop (XXXppm, XXXmA) Pacing (pacing rate XXX pulse/min and pacing current is XXX mA) is stopped.

Alarm suspend The alarm is silenced or suspended. SpO2 module off The SpO2 module is disconnected from the defibrillator. SpO2 module set The SpO2 module is connected to the defibrillator. CO2 module off The CO2 sensor kit is disconnected from the defibrillator. CO2 module set The CO2 sensor kit is connected to the defibrillator. Adrenalin The Medication key - Adrenalin is pressed. Atropine The Medication key - Atropine is pressed. Lidocaine The Medication key - Lidocaine is pressed. Other The Medication key - Other is pressed.

8. RECORDING


Recording example

Defibrillation Report Recording

Waveform at defibrillation and cardioversion and discharge information are recorded.

Procedure

1. Select “Defib” in ”Report” on the Report Setup screen. Refer to “Changing Report

and Recorder Settings” in this section.

2. Press the Record key. The Report recording mark appears on the screen. The

recording stops when all data are recorded.

To stop during recording, press the Record key again,

The data for the Defibrillation report recording remains in memory after the power off.

Compressed ECG waveform is recorded in three rows. The amplitude of the recorded

waveform is 1/2 of the waveform on the screen (on screen: 10 mm/1mV → 5 mm/1mV)

Waveform of 22 seconds (10 seconds before and 12 seconds after discharge) and setting at

the discharge are recorded for one discharge. Up to 44 discharges are recorded. After 44

data are saved, when the defibrillator detects another discharge, the data for that discharge

is saved and the oldest 11 data (both waveform and setting at discharge) are deleted.

When another discharge is performed within 22 seconds after previous discharge, the

recording is extended for 12 seconds after the second discharge and is counted as one

recording. In this case, maximum recordable discharge is less than 44.

Up to 6 discharge marks “ ” are recorded on one waveform.

Discharge information

Date: Date when defibrillation or cardioversion is performed.

Time: Clock time when defibrillation or cardioversion is performed.

Set Energy: Selected energy value

TTR: Skin-paddle (pad) contact impedance

Delivered: Output energy value. When TTR is 15 Ω or less, or 255 Ω or more, 0 J is

printed.

Shock Times: Total counts after the defibrillator power is turned on.

Manual: Defibrillation (“Manual Sync” is for Synchronized cardioversion and

“AED” is for AED)

TEST: Printed only when energy discharge test is performed.

OK: Test OK NG: Test NG

8. RECORDING


Recording examples

VF Analysis Report Recording

Waveforms of 6 seconds after the CHARGE/AED button is pressed and the analysis

result are recorded.

Procedure

1. Select “VF Analysis” in “Report” on the Report Setup screen. Refer to





The data of the VF Analysis report recording remains in memory when the

defibrillator power is turned off.

Waveforms for up to 124 VF analyses are saved. After 124 waveforms are saved,

when the defibrillator performs another VF analysis, the waveform for that VF

analysis is saved and the oldest 31 data are deleted.

8. RECORDING


Recording examples

(1) Heart rate and SpO2

Trend Report Recording

The trend graph and numeric data of heart rate, SpO2 , PR, etCO2 and RR which are

saved in memory are recorded.

Procedure

1. Select “Trend” in “Report” on the Report Setup screen. Refer to “Changing

Report and Recorder Settings” in this section.




The data of the Trend report recording remains in memory when the defibrillator

power is turned off.

You can select recorded trend time from 1, 2, 4, 8, 24 hours at Trend period on the

Report Setup screen. The relation between recorded trend time and interval of data

acquisition is shown below.

The maximum, minimum and average value in each data acquisition interval is

recorded.

The vertical axis scale changes according to the recorded data so that all data can

be recorded on the paper.

(1) Pulse rate and etCO2

Trend time (hours) 1 2 4 8 24 Data acquisition interval (minutes) 1 2 4 8 24

8. RECORDING


Event Recording

Recording example

ECG waveform from 4 seconds before to 8 seconds after the Event key is pressed

is recorded.

• When an alarm occurs, the Recording mark appears on the screen and

automatic alarm recording starts. The waveform from 4 seconds before to 12

seconds after the alarm occurrence is recorded.

• When energy charging starts, the Recording mark appears on the screen and

record on charging after discharge starts instead of event recording.

• If there is no paper in the recorder when the Event key is pressed, ECG

waveform at the time is saved as the data for alarm report recording.

(3) Respiration rate

8. RECORDING


Saving the AdministeredMedication

When “Medication” on the System Setup - Configuration screen is set to ON

(Default setting: OFF), the administered medication (adrenalin, atropine, lidocaine

and other) can be saved and recorded as the event list report and alarm report with

the 12 seconds of ECG waveforms.

1. Set “Medication” on the System Setup - Configuration screen to ON.

Refer to “System Setup Screen” in Section 3.

2. Press the Event key. The Event recording starts. The function keys change to

Adrenalin, Atropine, Lidocaine and Other function keys.

3. Press the key for the administered medication. The function keys return to the

normal function keys 5 seconds after the Event key is pressed.

4.. Set “Medication” on the System Setup - Configuration screen to OFF.

• Medications are not saved as sound data.

• During alam recording, if two or more medication keys are pressed, only the

latest medication is saved as the event report and alarm report.

8. RECORDING


Automatic Recording

Record On Charging AfterDischarge

NOTETo perform record on charging after discharge, set “Record on

charging after discharge” to ON on the System Setup-Configuration

screen before using the defibrillator.

The recording starts automatically when energy charging starts. During automatic

recording, the Recording mark appears on the screen. ECG waveform from the

start of charging to 12 or 6 seconds after discharge is recorded. When the energy is

externally discharged, information of the discharge is also recorded. To stop during

recording, press the Record key.

• If energy is not discharged within 40 seconds after charging is completed,

recording automatically stops.

• If the defibrillator starts charging while Event recording or another automatic

recording is being performed, record on charging after discharge starts instead.

• If another defibrillation or cardioversion is performed while record on charging

after discharge is being performed, recording is extended for 12 seconds after the

second defibrillation or cardioversion is performed.

Recording example

8. RECORDING


Alarm Recording NOTETo perform automatic alarm recording, set “Alarm recording” to ON on

the System Setup – Configuration screen before using the defibrillator.

Recording starts at the alarm occurrence. During alarm recording, the

Recording mark appears on the screen. The ECG waveform from 4 seconds before

to 8 seconds after the alarm occurrence is recorded. The waveform is saved for the

data of alarm report recording.

• When an alarm occurs during another recording, the currently performed

recording has priority.

• When energy charging starts during automatic alarm recording, record on

charging after discharge starts instead of automatic alarm recording. (Only when

“Record on charging after discharge” is set to ON (6s) or ON (12s) on the System

Setup-Configuration screen before using the defibrillator.)

Recording example

8. RECORDING


Periodic Recording Recording automatically starts at a preset interval. 12 seconds of the waveform(s)

selected at RecWave on the Recorder Setup screen is recorded. Besides ECG

waveforms, ID, date, time, ECG lead and ECG sensitivity are also recorded. Only

delayed ECG waveform is recorded.

For recording interval, Select either 15 min, 30 min, 60 min, 2hr or FREE at

PeriodicRec on the Recorder Setup screen.

When OFF is selected, automatic periodic recording is not performed.

When FREE is selected, recording is performed at the interval set on the “Periodic

recording interval (min)” on the System Setup - Configuration screen.

Recording example

8. RECORDING


Printed Letters and Marks

Item Printed letters Description

Event Report Event report recording

Defib Report Defibrillation report recording

Trend Report Trend report recording

List Report List report recording

Alarm Report Alarm report recording

Recording type

VF Report VF analysis report recording

Real Real time waveform recording Real time/Delayed recording*1

Delay Delayed waveform recording

Mon Monitoring mode

Manual Defib Manual defibrillation mode

AED AED mode

Fix Pace Fixed Pacing mode

Operation mode

Demand Pace Demand Pacing Mode

YYYY/MM/DD Year/Month/Day

MMM/DD/YYYY Month/Day/Year

YYYY/MMM/DD Year/Month/Day

Date*1

DD/MM/YYYY Day/Month/Year

Clock time *2 XX:XX:XX Hour:Minute:Second

Instrument ID *1 ID: XXXXX

ECG sensitivity ×1/4, ×1/2, ×1, ×2, ×4, AUTO×1/4, AUTO×1/2, AUTO×1, AUTO×2, AUTO×4

Paper speed *1 50 mm/s

25 mm/s

ECG lead PADDLE, I, II, III, aVR, aVL, aVF, V, AUX, TEST

SpO2 sensitivity *2 SpO2: ×8, ×4, ×2, ×1, ×1/2, ×1/4, ×1/8, AUTO

CO2 scale *1, *2 0-40 mmHg, 0-80 mmHg, 0-5.3kPa, 0-10.7kPa

AC Filter: ON AC filter ON AC filter *2

AC Filter: OFF AC filter OFF

T.C.: 0.32s 0.32 second Time constant *2

T.C.: 3.2 s 3.2 second

Heart rate *3 HR: XX

SpO2 *3 SpO2: XX%

Pulse rate *3 PR: XX

Respiration rate *3 RR: XX

etCO2 *3 etCO2: XX mmHg, XX kPa

The point of discharge

Selected energy Set: XXX J

Shock times Shock Times: XX

TTR TTR: XXX ohm

Delivered energy Delivered: XXX J

8. RECORDING


*1 The format can be set at System Setup screen.

*2 Can be set on the setup screen. Refer to Section 3.

*3 When an alarm occurs, the “*” mark is displayed before each value. (Example: HR:*200).

Item Printed letters Description

Test: OK Test discharge was performed normally. Test discharge result

Test: NG Test discharge failed.

Synchronization/non synchronization Sync/no display

Synchronization point

Pacing rate XX ppm

Pacing intensity XX mA

The point of pacing pulse output P

The point of event occurrence E

The point of implanted pacemaker pulse output

Medication Adrenalin Adrenalin was administered.

Atropine Atropine was administered.

Lidocaine Lidocaine was administered.

Other Other medication was administered.

8. RECORDING




Section 9 Messages andTroubleshooting

Messages ............................................................................................................................9.2

Troubleshooting ................................................................................................................. 9.10

General .................................................................................................................... 9.10

Defibrillation ............................................................................................................. 9.11

Pacing (TEC-5531 Series Only) ............................................................................... 9.11

Monitoring ............................................................................................................... 9.12

ECG .............................................................................................................. 9.12

SpO2 ............................................................................................................................................................................................... 9.13

CO2 ................................................................................................................................................................................................... 9.14

Recording ................................................................................................................ 9.15

Battery .................................................................................................................... 9.16

SD Card .................................................................................................................. 9.16

9. MESSAGES AND TROUBLESHOOTING


When trouble occurs, take quick action referring to the table below. If there is any

damage or the defibrillator or its peripheral component is suspected to be faulty,

turn the power off, attach a “Unusable” or “Repair request” label and contact your

Nihon Kohden distributor or representative.



Messages

Message Description Action

AED AED mode is selected. ---

Alarm off One or more alarms for parameters available for measurement is set to OFF. ---

Alarm silenced 1 min Alarm is silenced for 1 minute. ---

Alarm silenced 2 min Alarm is silenced for 2 minutes. ---

Alarms suspended All alarms are suspended. This message is displayed only during basic checks. ---

Alarms suspended 1 min Remaining time of alarm suspension is 1 minute. ---

Alarms suspended 2 min When no alarm is occurring and the SILENCE ALARMS key is pressed, this message is displayed. Remaining time of alarm suspension is 2 minutes.

---

Analyzing VF The defibrillator is performing VF/VT analysis. ---

APNEA Respiration was not detected for the period set on the Alarm screen. ---

Basic checks complete Basic checks are complete. --- Basic checks OK Basic checks are normally complete. ---

Battery discharged Very little battery charge remains. ---

Battery charge timed out During battery test The battery was not fully charged 5 hours after battery charging started.

---

Battery charging error During battery test An error occurred in battery charging

---

Battery discharge timed out

During battery test The voltage did not decrease to the specified level 3 hours after battery discharging started.

---

Battery test complete Appears when battery test finishes. (when charging for the next use is complete) ---

Battery OK Battery test result is 70 to 100% ---

Battery WEAK Battery test result is 50 to 69%. ---




A card other than specified ones is inserted. Cannot use card

A card for version upgrade is inserted on the Save Report screen.

---

Capacitor test fail Capacitor test failed. ---

Capacitor test pass Capacitor test result is OK. ---

Change disposable pads Deteriorated disposable pads (Abnormal polarization voltage in PADDLE lead) ---

Change ECG electrodes Deteriorated ECG electrodes (Abnormal polarization voltage in ECG leads) ---

Change to monitor mode The multi-function key was pressed in a mode other than the MONITOR mode ---

CHARGED In manual or AED mode, high voltage energy charging is complete. ---

Charge battery There is little battery charge remaining. The mark is displayed. ---

CHARGING In manual or AED mode, the instrument is adjusting the energy in the capacitor. The defibrillator is charging high voltage energy.

---

Charging battery During battery test The battery is being charged for the battery test.

---

An ECG electrode is detached from the patient. --- Check ECG electrodes

ECG connection cable or external ECG cable is disconnected from the ECG connector. ---

In manual or AED mode, the contact impedance of the disposable pads is over 350 Ω.

When PADDLE lead is selected, disposable pads are not attached to the patient firmly.

• Clip hair on the skin where pads are placed, then firmly attach the disposable pads to the patient chest.

• Firmly connect the pad adaptor and disposable pads.

The pad adaptor is disconnected from the disposable pads.

Firmly connect the pad adaptor and disposable pads.

Check disposable pads

In FIXED or DEMAND pacing mode, the disposable pad is not firmly attached to the patient.

Firmly attach the disposable pads to the patient chest.

Check patient In background analysis, patient ECG was judged as a shockable rhythm. ---

0




Check pulse This message appears: • After third defibrillation is performed in

AED mode • When the defibrillator did not detect a

shockable rhythm.

---

The probe attachment site is not appropriate. Attach the probe at a site indicated in the probe operator’s manual.

Check SpO2 probe site

The probe lifetime is expired. Replace the probe with a new one.

The probe is detached from the patient. Check the probe attachment condition and remove the cause.

The probe is disconnected from the SpO2 adapter.

Securely connect the probe to the SpO2 adapter.

Check SpO2 probe

The probe expired. Replace the probe with a new one.

Checking battery During battery test Battery capacity is being checked.

---

Connect AC Power or Charge Battery

In AED mode, the battery is discharged and the energy for the defibrillation cannot be charged.

Replace the battery or use AC power.

Connect external paddles to paddle holders

Appears when performing basic checks and the external paddles are not set on the paddle holders.

---

Connect to AC power The defibrillator is not connected to AC power during battery test.

Connect the defibrillator to AC power.

In FIXED or DEMAND pacing mode, the pad adaptor is not connected to the defibrillator.

Connect the pad adaptor to the defibrillator and then turn the Energy/Mode Select control to FIXED or DEMAND position

In manual or AED mode, paddles or disposable pads are not connected to the defibrillator.

Connect the paddles or disposable pads to the defibrillator.

Connect paddle

When PADDLE lead is selected, paddles or disposable pads are not connected to the defibrillator.

Connect the paddles or disposable pads to the defibrillator.

Insufficient light Refer to the operator’s manual of the CO2 sensor kit.

CO2 adapter abnormality

CO2 adapter is faulty or deteriorated. Replace the CO2 adapter with a new one.

CO2 sensor not working CO2 sensor is faulty or deteriorated. Replace the CO2 sensor with a new one.

CO2 module not working CO2 module is faulty. Contact your Nihon Kohden distributor or representative.

CO2 module disconnected

CO2 cable is disconnected from the defibrillator.

You can make this message disappear by pressing the Silence alarms key. Connect the CO2 cable to the SpO2/CO2 connector. If the message still appears, contact your Nihon Kohden distributor or representative.




Defibrillation necessary. Check ECG

By VF analysis with the CHARGE/AED button, defibrillation was judged to be necessary.

---

Defibrillation not necessary. Check ECG.

By VF analysis with the CHARGE/AED button, defibrillation was judged to be unnecessary.

---

Demand Demand pacing mode is selected. ---

Discharging battery During battery test The battery is being discharged for battery test.

---

Did the alarm sound? The basic checks-Alarm check is being performed. ---

Did the recorder print? The basic checks-Recorder check is being performed. ---

Enter password Password to enter manual mode is required. Enter a password.

Enter password again Entered password is not correct. Enter the correct password.

ERROR A××× Faulty HV

ERROR C××× Communication error

ERROR D××× Faulty ROM/RAM

ERROR K××× Faulty keys

ERROR P××× Faulty pacing unit

Turn the Energy/Mode Select control to the OFF position. Then turn on the defibrillator and do the same operation that you did when the error message appeared. If the error message still appears, immediately turn off the power and contact your Nihon Kohden distributor or representative.

FET error The circuit to measure remaining battery charge is faulty.

Contact your Nihon Kohden distributor or representative.

File Error Sound data saved in the SD card is damaged. ---

Fixed FIXED pacing mode is selected. ---

High impedance Skin-paddle contact impedance is too high. Press the paddles on the patient firmly.

High voltage monitor error Faulty high voltage unit Turn the Energy/Mode Select control to the OFF position. Then turn on the defibrillator and do the same operation that you did when the error message appeared. If the error message still appears, immediately turn off the power and contact your Nihon Kohden distributor or representative.




Appears 5 seconds after the confirmation message after CPR is displayed. ---

If no pulse, press CHARGE/AED button

When not performing CPR, appears 5 seconds after the message confirming pulse. ---

If no pulse, start CPR When CPR time is set in AED mode, this message appears after third defibrillation. ---

INTERNAL DISCHARGE Energy was not discharged to the patient. ---

Insert ATA CARD You tried to save data in a memory card when no card was inserted in the defibrillator.

Insert a specified memory card into the defibrillator.

Insert battery You tried to do the battery test when the battery was not inserted in the defibrillator. ---

Left side CO2 not measured A CO2 cable was connected to the left SpO2/CO2 connector when a CO2 cable was already connected to the right SpO2/CO2 connector.

Only one CO2 can be measured. If two CO2 cables are connected, only the first connected CO2 is measured. Disconnect one of the CO2 cables.

Left side SpO2 not measured A SpO2 cable was connected to the left SpO2/CO2 connector when a SpO2 cable was already connected to the right SpO2/CO2 connector.

Only one SpO2 can be measured. If two SpO2 cables are connected, only the first connected SpO2 is measured. Disconnect one of the SpO2 cables.

Low impedance Skin-paddle contact impedance is too low. Check that the paddles do not touch each other.

Manual defibrillation? “Manual defib confirmation” is set to “confirm” and the Energy/Mode select control is turned to the position of defibrillation.

---

No report data You tried to do report recording when there was no data for report recording saved in the defibrillator

---

Not enough free memory Very little free memory in the SD card. ---

Now pacing Pacing is started. ---

Now playing Sound is playing back ---

Out of recording paper Change the role of recording paper. Out of paper

Recorder door is open. Press the magazine until it clicks.

Faulty high voltage unit Overheating

The defibrillator discharged too frequently and the internal temperature is too high.

Turn the Energy/Mode Select control to the OFF position and leave the defibrillator for 20 minutes. Then turn on the defibrillator and check if the message appears again. If it still appears, immediately turn off the power and contact your Nihon Kohden distributor or representative.




Pacing stopped (ECG lead disconnected)

Pacing stopped because: (1) An electrode lead is disconnected from an

electrode. (2) An electrode is detached from the patient. (3) Electrode lead is disconnected from the

JC-762V connection cable. (4) Bad contact between the electrode and

lead clip. (5) Electrode lead discontinuity (6) Abnormally high polarization voltage

(1) Firmly connect the electrode lead to the

ECG electrode. (2) Replace the electrodes with new ones. (3) Firmly connect the electrode lead to the

connection cable. (4) Replace the electrode lead with a new one.

(5) Replace the electrode lead with a new one. (6) Replace the electrodes with new ones.

Pacing stopped (paddle disconnected)

Pacing stopped because: (1) The pad adaptor is disconnected from the

disposable pads.

(2) The disposable pads are detached from the patient.

(1) Firmly connect the pads to the pad

adaptor. Firmly connect the pad adaptor to the paddle connector.

(2) Attach the disposable pads to the patient.

Power abnormality Input power voltage is too high. ---

Press CHARGE/AED button

When the “Check Pulse Pattern” on the System Setup screen is set to 3 (no checking pulse), in AED mode, this message appears 5 seconds after the “Check patient” message appears.

---

Press CHARGE button Appears as the guidance for capacitor test. ---

Press DISCHARGE buttons until discharge

Appears in discharge check. ---

Relay drive error Faulty high voltage unit Contact your Nihon Kohden distributor or representative.

Replace battery Battery test result is 0 to 49%. The defibrillator judged that the battery should be replaced with a new one.

---

A CO2 cable was connected to the right SpO2/CO2 connector when a CO2 cable was already connected to the left SpO2/CO2 connector.

Right side CO2 not measured

Defibrillator power is turned on when two CO2 cables are connected.

Only one CO2 can be measured. If two CO2 cables are connected, only the first connected CO2 is measured. Disconnect one of the CO2 cables.

A SpO2 cable was connected to the right SpO2/CO2 connector when a SpO2 cable was already connected to the left SpO2/CO2 connector.

Right side SpO2 not measured

Defibrillator power is turned on when two SpO2 cables are connected.

Only one SpO2 can be measured. If two SpO2 cables are connected, only the first connected SpO2 is measured. Disconnect one of the SpO2 cables.

SD: Insert a Card SD card is not inserted. Insert the SD card into the SD card slot.

SD: Card Error Could not access the SD card. ---

SD: Ready The SD card is ready to use. ---

SD: Accessing Accessing the SD card. ---




The instrument is searching for correct pulse waveform.

SpO2 value cannot be measured because of unstable pulse waveform.

Wait until the pulse waveform is detected. Searching for SpO2 pulse

The probe is detached from the patient. Check the probe attachment and remove the cause.

Select a different lead During pacing in DEMAND mode, ECG lead is set to a lead other than ECG leads. ---

Under the setting that does not permit synchronized cardioversion with PADDLE lead, SYNC mode is selected with PADDLE lead.

---

SYNC button is pressed when TEST lead is selected. ---

Select ECG lead

TEST lead is selected in pacing mode. ---

Select AED or monitor if not manual defibrillation?

When “Manual defib confirmation” is set to “password” or “confirmation” and the Energy/Mode select control is turned to the position of defibrillation.

---

Set energy to 50J or less Above 50 J is selected when the internal paddles are connected to the defibrillator. ---

Set recording paper Recording paper is not set in the recorder during basic checks.

Set the paper in the recorder.

Set to 200J You tried to perform the HV capacitor test with the energy set to other than 200J.

Set the energy to 200J.

Shutdown NOW The defibrillator is shutting down now. NOTE

While the “Shutdown NOW” message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. The internal data may be damaged.

---

SpO2 module disconnected SpO2 cable is disconnected from the defibrillator.

Connect the SpO2 to the SpO2/CO2 connector. If the message still appears, contact your Nihon Kohden distributor or representative.

The “M” mark is displayed beside the SpO2 value.

SpO2 measurement is unstable due to patient body movement

If this message appears frequently, check the patient and probe attachment condition. Reattach the probe to the patient if necessary.




SpO2 module not working

Faulty SpO2 module Contact your Nihon Kohden distributor or representative.

The probe lifetime is expired. Replace the probe with a new one.

Probe discontinuity or short-circuit Replace the probe with a new one.

Faulty cable of the SpO2 adapter Replace the SpO2 adapter with a new one.

SpO2 probe not working

Faulty SpO2 probe Replace the SpO2 probe with a new one. If the message still appears, replace the SpO2 adapter.

Stand clear In AED mode, the CHARGE/AED button is pressed and the defibrillator starts VF analysis. ---

Stand clear and press DISCHARGE buttons

In AED mode, charging defibrillation energy is complete. ---

Start CPR

This message appears: • When CPR is required • After discharge for one sequence • When nonshockable rhythm is detected

---

SYNC Synchronized cardioversion is selected. ---

Test fail Energy was not discharged properly in discharge test. ---

Test OK Energy was discharged properly in energy discharge test. ---

Testing. Please wait. The defibrillator is performing the HV capacitor test. ---

Time to replace battery More than one year has passed since the key for “Reset” was pressed. ---

In FIXED or DEMAND pacing mode, disposable pads are not used. --- Use disposable pads

In AED mode, disposable pads are not used. ---

Use another instrument ERROR A××× appeared in basic checks. ---

Was the voice heard? The basic checks-voice check is being performed.

Confirm that the voice is heard.



Troubleshooting

General

Problem Possible Cause Action

The instrument is used for many hours. There is no abnormality in the instrument.

The instrument heats up.

Instrument abnormality Turn the Energy/Mode select control to OFF position and disconnect the power cord. Contact your Nihon Kohden distributor or representative.

The power cord is disconnected. Firmly connect the power cord to the AC outlet and the defibrillator.

The battery is not installed. Install the specified battery. Faulty battery Replace the battery with a new one

(NKB-301V). Remaining battery charge is low. Charge the battery.

No operation when the instrument is turned on.

Instrument abnormality Contact your Nihon Kohden distributor or representative

Screen is dim. Waveform and characters are not seen.

Instrument abnormality Contact your Nihon Kohden distributor or representative

The printed date is JAN/01/80. The backup battery is almost discharged.

Replace the backup battery with a new one. For replacement, contact your Nihon Kohden distributor or representative. (Under normal use condition, the backup battery lifetime is about 6 years.)

Faulty internal memory Contact your Nihon Kohden distributor or representative.

The report data are not saved.

On the Setup screen, the report data were deleted.

Deleted data cannot be recovered.

All settings set in the Setup screen and System Setup screen return to the default settings.

Faulty internal memory Contact your Nihon Kohden distributor or representative.

When the battery is installed, the instrument suddenly changes to battery operation.

When the battery is not installed, the instrument power suddenly drops.

Power voltage changed. Confirm the AC power cord connection. When the power cord is properly connected and the symptom still appears, contact your Nihon Kohden distributor or representative.

--- Set the date and time on the Date/Screen screen. Refer to Section 3.

The date and time printed on the recording paper is incorrect.

The backup battery for the clock is discharged.


On the screen, there are some pixels which have randomly abnormal color or do not light.

For the TFT LCD screen, it is considered normal if some pixels have randomly abnormal color or do not light.

---

No sound is heard. “Voice prompt” is set to “OFF” in the System Setup - Configuration screen

Increase the volume.

Faulty speaker or speaker cable discontinuity

Repair is necessary. Contact your Nihon Kohden distributor or representative.



Defibrillation

Pacing (TEC-5531 Series Only)


In battery operation, the battery is almost discharged.

Operate the defibrillator on AC power and recharge the battery. The battery is automatically charged when the defibrillator is connected to AC power.

The defibrillator self-discharges the energy during charging.

Faulty high voltage unit.

(Error code appears on the screen.)

When an error code appears on the screen, use another instrument. The instrument is faulty. Contact your Nihon Kohden distributor or representative.

Appropriate lead is not selected. Change to the appropriate lead. Cannot switch to synchronized mode.

You tried to perform synchronized cardioversion with the PADDLE lead but synchronized cardioversion with the PADDLE lead is set to OFF on the Paddle Setup screen.

On the Paddle Setup screen, set the “Sync by paddle lead” to ON.

TTR is 15 Ω or less Check that the paddles do not touch each other.

“0 J” is printed on the defibrillation report recording.

TTR is 255 Ω or more. Press the paddles on the patient firmly.


Although the PULSE lamp is lit, pacing pulse does not appear on the ECG.

Pacing pulse is not output. Contact your Nihon Kohden distributor or representative.

Pacing energy is set to 0 mA. Set the appropriate pacing energy with the PACING OUTPUT Up/Down key.

In DEMAND mode, selected pacing rate is slower than the patient heart rate.

Set the pacing rate appropriate for the patient heart rate. When the patient heart rate is slower than the selected pacing rate, pacing pulse is output automatically.

Although the START/STOP key is pressed, pacing does not start.

Faulty pacing function

(system error code appears on the screen)




Monitoring

ECG


Dotted lines appear instead of the ECG waveforms.

• An ECG electrode is detached. • An electrode lead is disconnected

from the electrode. • The ECG connection cable is

disconnected from the defibrillator. • An electrode lead is faulty.

Remove the cause. If the symptom still appears, change the lead. If the symptom still appears, the instrument is faulty. Contact your Nihon Kohden distributor or representative.

Baseline drifting Patient body movement Check the patient. AC interference (50 or 60 Hz sine wave is superimposed on the ECG waveform.)

On the Setup screen, AC hum filter is set to off.

• On the Setup screen, set the AC hum filter to on.

• Check if there is AC interference with other instruments, and remove the cause.

• Electrode lead discontinuity • Dirty electrode

Replace the electrodes or leads with new ones.

ECG waveform does not appear on the screen although electrodes are connected properly.

New and old or other types of electrodes are used together.

Use the same type electrodes which are purchased together.

No sync sound “QRS Volume” is set to “0” in the Setup screen - QRS Setup.


“QRS Sound” is set to “SpO2” in the Setup screen - QRS Setup.

Set “QRS Sound” to “ECG”.



QRS sync mark is not displayed. On the Setup screen, pacing pulse rejection is set to ON and large amplitude AC interference noise is on the ECG waveform.

• Remove the cause of the noise. • On the Setup screen, set the AC hum

filter to ON. • On the Setup screen, set pacing pulse

rejection to OFF. Sync sound is irregular although there is no arrhythmia.

Noise was misjudged to be QRS. Remove the cause of the noise.

The Silence alarms key is pressed. Press the Silence alarms key again. On the Setup screen, alarm is set to OFF.

On the Setup screen, set the upper/lower limit of each vital alarm.

No alarm is generated

Faulty speaker Repair is necessary. Contact your Nihon Kohden distributor or representative.



SpO2


The SpO2 adapter cable is disconnected from the SpO2/CO2 connector.

Connect the SpO2 adapter to the SpO2/CO2 connector.

The SpO2 probe is disconnected from the SpO2 adapter.

Firmly connect the probe to the SpO2 adapter.

Cable discontinuity in SpO2 adapter or probe

Replace the SpO2 adapter or probe.

SpO2 value is not displayed on the screen.

SpO2 probe attachment to the patient is loose.

Firmly attach the probe to the patient.

SpO2 probe attachment to the patient is loose.

Firmly attach the probe to the patient. Dotted lines appear instead of the pulse waveforms.

Faulty DSI or DSI/AUX out interface unit or discontinuity


SpO2 probe is disconnected from the SpO2 adapter.

Connect the probe to the SpO2 adapter. Pulse waveform is not displayed on the screen.

SpO2 adapter is disconnected from the defibrillator.

Connect the SpO2 adapter to the defibrillator.

Inappropriate probe size Use a probe appropriate for the patient. The probe is attached to the same limb that is used for NIBP measurement or an IBP catheter.

Attach the probe to the opposite limb. Avoid sites where the blood circulation changes greatly.

Using electrical surgery unit. Keep the SpO2 adapter cable and probe cable away from an electrical surgery unit. Wait until the pulse waveform becomes stable.

Unstable SpO2 value

Measuring at a site with venous pulse. Correct measurement cannot be done. Probe was disinfected in a way other than the specified way.

Replace the probe with a new one. Use the specified disinfecting method.

Deformed or damaged SpO2 probe

SpO2 probe is repeatedly used. Replace the probe with a new one when its lifetime is over.

Interference by external light Cover the probe attachment site to block the light.

Sine noise on the pulse waveform

Correct AC line frequency is not set. Check the actual AC line frequency and the AC line frequency settings.

No sync sound “QRS Volume” is set to “0” in the Setup screen - QRS Setup.


“QRS Sound” is set to “ECG” in the Setup screen - QRS Setup.

Set “QRS Sound” to “SpO2”.





CO2


The CO2 sensor kit cable is disconnected from the SpO2/CO2 connector.

Connect the CO2 sensor kit cable to the SpO2/CO2 connector.

CO2 gas is in the inspiration. With the CO2 sensor kit, measurements are based on the assumption of no CO2 gas in the inspiration. Do not connect a Jackson Rees respiration circuit or Mapleson D respiration circuit to the patient. Measurement cannot be done correctly.

The airway adapter is dirty. Replace the airway adapter with a new one.

The measured value is not displayed on the screen.

The measurement is preformed where atmospheric pressure is low, such as at high altitude.

Consider the atmospheric pressure when making evaluations.

The measured value is high. N2O is mixed in the inspiration or when high concentration of oxygen is inspired.

Remove the cause and measure again.

Jackson Rees respiration circuit or Mapleson D respiration circuit is connected to the patient.

Cannot measure correctly. Do not connect a Jackson Rees respiration circuit or Mapleson D respiration circuit to the patient.

The respiration rate of the patient is very high.

Cannot measure correctly.

The respiration is irregular. Cannot measure correctly. Oscillation Check the respirator and remove the

cause.

The measured value is inaccurate.

Currently doing suction. Do not let the respirator tube in the CO2 adapter.

The airway adapter is detached from the patient.

Check the airway adapter attachment. CO2 value does not change.

The patient is in apnea. The previous value is displayed on the screen until the next inspiration is detected. Check patient ventilation.

Oscillation Check the respirator and remove the cause.

The respiration waveform does not appear.

The CO2 sensor is disconnected from the respiration circuit.

Connect the CO2 sensor to the respiration circuit.

CO2 sensor or CO2 adapter is faulty. Replace the CO2 sensor or CO2 adapter with a new one.

The red LED on the CO2 adapter blinks.

The respiration has not been detected for longer than 20 s.

The red LED blinks when the respiration has not been detected for longer than 20 s regardless of the alarm setting on the defibrillator.



Recording


The thermal head is dirty. • Clean the thermal head with NK-specified head cleaning pen. If the symptom still appears, replace the thermal head. Contact your Nihon Kohden distributor or representative.

• Perform the recorder Test on the System Setup screen to check the printing quality.

Printing is blurred. Dots are missing.

NK-specified paper is not used. Use NK-specified recording paper. NK-specified paper is not used. Use NK-specified recording paper. Recording paper cannot be set

correctly. The slide plate is not located correctly. Locate the slide plate correctly. Refer to Section 2 “Loading the Recording Paper”.

The recording paper is not loaded. Load new recording paper. Recording unit door is not properly closed.

Close the door until it clicks.

The Recording lamp does not light. Press the Record key again. If the lamp does not light when you press the Record key, the key is faulty. Contact your Nihon Kohden distributor or representative.

There is no printing.

The recording paper is set with the wrong side facing up.

Set the recording paper correctly.

Paper skews to one side. The recording paper is not loaded correctly.

Set the paper straight. Refer to Section 2 “Loading the Recording Paper”.

Printing is light. The recording unit temperature is too hot.

Cool it down in a cooler place. If the symptom still appears, the recording unit is faulty. Contact your Nihon Kohden distributor or representative.



Battery

SD Card


The battery charging lamp is blinking. The defibrillator is too hot. Bring the defibrillator to a cool place. When the battery temperature decreases, charging resumes.

Faulty battery Replace the battery with a new one. After starting battery charging, the charging stops. (neither battery charging lamp nor battery charge complete lamp lights.)

Charging circuit is not working. Faulty charging circuit. Contact your Nihon Kohden distributor or representative.

The “Replace battery” message appears.

The battery is deteriorated. Replace the battery with a new one.

Symptom Possible Cause Action

Data cannot be saved in the memory card.

A version upgrade card is inserted instead of a memory card.

Insert a specified card.

The card is not inserted. Insert a specified card. The card is not inserted properly. Firmly insert the card.

A card other than specified card is inserted.

Insert a specified card.

Memory is full. Use a new card, or delete unnecessary data.

The card is write-protected. Release the write-protect. The card is not formatted. Format the card in the System Setup -



Section 10 Maintenance

Cleaning, Disinfecting and Sterilization ............................................................................ 10.1

Defibrillator ............................................................................................................ 10.1

External Paddles .................................................................................................... 10.1

Internal Paddles ..................................................................................................... 10.2

Battery ................................................................................................................... 10.2

ECG Electrode Leads and ECG Connection Cable ............................................... 10.3

Disposal and Replacement .............................................................................................. 10.4

Battery ................................................................................................................... 10.4

Disposal of Battery Pack ............................................................................. 10.4

Replacing Battery Pack ............................................................................... 10.4

Disposable Pads .................................................................................................... 10.6

Lifetime ........................................................................................................ 10.6

Disposal ....................................................................................................... 10.6

ECG ....................................................................................................................... 10.6

Electrode Lifetime ........................................................................................ 10.6

Disposing of Electrodes ............................................................................... 10.6

Check After Use ............................................................................................................... 10.7

Periodical Checks ............................................................................................................ 10.8

Checking External Paddles .................................................................................... 10.8

Checking 270 J Energy Charge and Disarm ......................................................... 10.9

Battery Test .......................................................................................................... 10.10

Checking the Battery Appearance ....................................................................... 10.12

HV Capacitor Test ................................................................................................ 10.13

Recorder Test ...................................................................................................... 10.14

Date and Time Adjustment .................................................................................. 10.14

Periodical Replacement Schedule ................................................................................. 10.14

Repair Parts Availability Policy ....................................................................................... 10.14

Storage .......................................................................................................................... 10.15

Defibrillator and Battery ....................................................................................... 10.15

Short Term Storage (Ready for Use at Any Time) ..................................... 10.15

Long Term Storage .................................................................................... 10.15

Disposable Pads and ECG Electrodes ................................................................ 10.16

10. MAINTENANCE


Cleaning, Disinfecting and Sterilization

CAUTIONBefore maintenance, cleaning or disinfection, turn the defibrillator



instruction may result in electrical shock and defibrillator malfunction.

For SpO2 adapter, SpO2 probe, CO2 sensor cable and CO2 sensor, refer to each


CAUTION• Do not use the following chemicals to clean the defibrillator, pads

adaptor, ECG connection cable. These chemicals melt or crack the

plastic surface.

Thinner, Trichloroethylene, Carbon tetrachloride, Gasoline, Benzine,

Kerosene, Benzene, Toluene

• Do not put gauze moistened with physiological saline solution on the

paddle holders. This may cause rusting or discoloration of the

electrode plate of the external paddle and test electrode (metal parts

of the paddle holders).

Wipe the dirt from the exterior surface of the defibrillator and paddle holders and

the paste (GELAID) from the test electrodes with a soft cloth moistened with water

or disinfecting alcohol then wipe them with a clean and dry cloth.

CAUTION• Do not bend the connector pins of the external paddles. If pins are

bent, replace the paddle with a new one. With a bent pin, energy

cannot be discharged because of poor continuity.

• The external paddles cannot be sterilized.

• Do not heat the external paddles above 60°C (140°F) or put them in

liquid.

Wipe the paste (GELAID) from the electrodes and handles of the external paddles

with a soft cloth moistened with disinfecting alcohol then wipe them with a clean

and dry cloth.

Defibrillator

External Paddles

10. MAINTENANCE


CAUTION• Do not bend the connector pins of the internal paddles. If pins are

bent, replace the paddle with a new one. With a bent pin, energy

cannot be discharged because of poor continuity.

• Replace an internal paddle with a new one after about 100 times

autoclaving because the internal paddles can withstand up to 100

times autoclaving under the following conditions. More autoclaving

may cause cable discontinuity and damage the cable surface.

• Replace an internal paddle with a new one after about 100 times EOG

sterilization.

NOTEThe electrode and the handle cannot be separated.

Wipe dirt from the electrodes and handles of the internal paddles with a soft cloth

moistened with water or disinfecting alcohol then wipe them with a clean and dry

cloth.

After cleaning, sterilize the internal paddles by autoclaving or EOG (ethylene oxide

gas). The following sterilizing conditions are examples. Refer to the manual of the

sterilizing equipment.

EOG

Gas: EO 30% + CO2 70%

EO concentration: 940 mg/L

Temperature: 50°C, 122°F

Relative humidity: 50%

Pressure: 1 kg/cm2 (98 kPa )

Period: at least 4 hours

To remove the remaining gas from the paddles after sterilization, first decrease

the internal pressure of the sterilization equipment to − 760 mmHg with a

vacuum pump, then add carbon dioxide or antiseptic gas in the equipment.

Repeat this procedure (aeration) at least 5 times. Take the paddles out of the

sterilization equipment and do not use them for at least 20 days.

Autoclaving

Pressure 2.0 kg/cm2 (196 kPa)

Temperature 132°C (269.6°F)

Period 10 minutes

Internal Paddles

Remove dirt from the battery every 6 months.Battery

10. MAINTENANCE


Thoroughly wipe ECG electrode leads and an ECG connection cable with a soft

cloth moistened with water, neutral detergent or disinfecting alcohol.

To disinfect, wipe it with a soft cloth moistened with any of the disinfectants listed

below. Use the recommended concentration.

Disinfectant Concentration (%)

Glutaraldehyde solution 2.0

Hydrochloric alkyldiaminoethylglycine 0.5

Benzalkonium chloride 0.2

Benzethonium chloride solution 0.2

Chlorohexidine gluconate solution 0.5

ECG Electrode Leads andECG Connection Cable

10. MAINTENANCE


Disposal of Battery Pack

NOTEThe battery is NiMH. Before disposing of the battery, check with your

local solid waste officials for details in your area for recycling options

or proper disposal. The battery is recyclable. At the end of its useful

life, under various state and local laws, it may be illegal to dispose of

this battery into the municipal waste stream. Before disposing of the

defibrillator, remove the battery from the defibrillator.

Replacing Battery Pack

Replace the battery pack with a new one after one year.

NOTE• Use only the NKB-301V rechargeable battery.

• Write down the battery replacement date on the battery before

battery replacement.

• Battery replacement must be performed only by service staff.

1. On the new battery write the date when usage starts.

2. Confirm that the Energy/Mode Select control is set to OFF. Disconnect the

power cord from the defibrillator.

CAUTIONBefore battery replacement, turn off the defibrillator power and

disconnect the AC power cord from the defibrillator. Otherwise, the

operator may get an electrical shock.

NOTEWhile the “Shutdown NOW” message is displayed on the screen, do

not disconnect the power cord from the defibrillator or AC outlet and

do not remove the battery pack from the defibrillator. Otherwise, the

internal data may be damaged.

3. Turn the knob on the battery holder cover counterclockwise and remove the

battery pack holder cover.

Disposal and Replacement

Battery

10. MAINTENANCE


4. Disconnect the battery cable by holding the battery cable connector and

remove the battery from the defibrillator.

5. Insert the new battery into the battery pack holder.

6. Securely connect the battery connector to the connector inside the battery

pack holder until it clicks and locks.

7. Close the battery pack holder cover. Be careful not to pinch the cable. Secure

the battery pack holder cover by turning the knob clockwise.

8. On the battery check label, write the date when usage starts.

Attach the label on the defibrillator so that you can see them easily, for

example, on the upper part of the right side panel.

9. Reset the date of first use of the battery.

1) Display the System Setup - Battery Test screen.

2) Press the Reset key to reset the date of first use of the battery. The “Time

to replace battery” message appears one year after the Reset key is pressed.

NOTEYou must do this step when the battery is replaced. Otherwise, the

defibrillator does not display the “Time to replace battery” message to

prompt you to replace the battery.

10. MAINTENANCE


Disposable Pads

ECG

Lifetime

WARNING• Replace pads after 1 hour pacing.

• Do not use after expiration date.

CAUTIONFor long term ECG monitoring, replace pads every 24 hours.

Disposal

Follow your local laws for disposing of medical waste. To prevent second

infection, do not dispose of the disposable pads with other waste.

Electrode Lifetime

Replace the ECG disposable electrodes with new ones about every 24 hours.

Otherwise the contact impedance between the skin and electrode may increase due

to drying of the electrode gel or deterioration of adhesives and correct

measurement cannot be obtained.

If electrode contact becomes poor, replace it with a new one.

Disposing of Electrodes

Follow your local laws for disposing of medical waste. To prevent second

infection, do not dispose of the disposable pads with other waste.

For SpO2 adapter, SpO2 probe, CO2 sensor cable and CO2 sensor, refer to each


10. MAINTENANCE


Check After Use

To ensure correct performance for use in an emergency, check the following items

after every usage. If you find any trouble, check the defibrillator referring to

“Inspection” in this section and take necessary remedial actions. If any

abnormality is found, attach a “Not available” or “Repair requested” label on the

defibrillator and contact your Nihon Kohden distributor or representative.

Before turning off the power

• Temporarily changed settings on the System Setup screen and Setup screen are

returned to original settings.

• When the Energy/Mode Select control is set to DISARM position, “0 J” is


• Energy is not still being charged.

• Cables are disconnected from the defibrillator.

Abnormality

• There was no abnormality during operation.

• No error indication is on the screen.

• The screen display is normal and can be seen clearly.

• The defibrillator is not too hot when touched.

• All settings are as you set them.

Appearance

• The defibrillator is not dirty or damaged.

• The metal plate of the paddle holder and paddle electrode is not rusted or

discolored.

• The operation panel and label on the defibrillator are not dirty or missing.

• There is no crack or damage on the defibrillator and paddles.

• There is no damage on the power cord.

• The battery check date and battery replacement date are not expired.

• Paddles are cleaned.

• Internal paddles are sterilized if necessary.

• There is enough paste (GELAID).

• If the defibrillator is in contact with liquid, it is wiped and dried thoroughly.

• Accessories are kept neatly.

• Disposable pads and ECG electrodes are disposed of properly so as not to cause

second infection.

• There are enough consumables such as recording paper.

• The power cord is connected to the defibrillator to maintain battery charge.

• The Energy/Mode Select control is set to OFF.

• There are no chemical solutions or water left around the defibrillator.

• The defibrillator storage condition is proper.

10. MAINTENANCE


CAUTION• Assembly and disassembly of any component in the instrument


• Before maintenance, cleaning or disinfection, turn the defibrillator



instruction may result in electrical shock and defibrillator

malfunction.

Perform the Basic Checks every day. Refer to Section 2 “Basic Checks”.

Perform the following tests and checking once a month. If any abnormality is

found, contact your Nihon Kohden distributor or representative.

• Checking external paddles

• Basic Checks

• Checking 270 J energy charge and disarm

• Battery test

• HV capacitor test

• Recorder test

• Date and time adjustment

Check the battery appearance every 6 months.

To check the energy discharge, use the Basic Checks screen.

• Check that there is no crack or damage on the resin of external paddles and resin

of adult electrodes.

• Check that there is no scratch or damage on the cables and its mold part.

• Pull the DISCHARGE buttons on the APEX and STERNUM paddles. If the

button is pulled out, the button attachment is broken and replacement is

necessary.

• Check energy discharge. Check the operation of the CHARGE button and

DISCHARGE buttons. Confirm that there is no discontinuity in the cables.

Checking External Paddles

Periodical Checks

10. MAINTENANCE


Checking 270 J EnergyCharge and Disarm

Checks that the defibrillator automatically disarms.

1. Turn the Energy/Mode Select control to 270 J.

2. Leaving the paddles on their holders, press the CHARGE button on the APEX

paddle to start charging.

3. Confirm that there is a beeping sound, the “CHARGING” message appears on

the screen and the CHARGE lamp on the APEX paddle blinks.

4. When charging is completed, there is a continuous buzzing sound and the

CHARGE lamp lights. Confirm that the “CHARGED” message and “270 J” is


5. Turn the Energy/Mode select control to the DISARM position.

6. Check that the energy value on the lower right of the screen changes to 0 J in

20 seconds. If not, contact your Nihon Kohden distributor or representative.

NOTE• Do not discharge manually by pressing the DISCHARGE buttons.

• If any error message appears during the test, contact your Nihon

Kohden distributor or representative.

• Do not continuously perform this check more than the specified

number of charge/discharge cycles. Refer to “Specification -

Defibrillator - Maximum continuous charge/discharge cycles at 270 J”

in Section 11.

10. MAINTENANCE


This checks the battery capacity by charging and discharging the battery. Perform

this test once a month.

WARNINGIf defibrillation or cardioversion is necessary during battery test,


not use battery power because the battery may have been discharged

by the battery test.

NOTE• It takes about 4.5 hours to test a fully charged new battery at the

20°C ambient temperature. It takes up to 6 hours to test a battery

which has little remaining charge.

• If the power cord is disconnected from the defibrillator during the

battery test, the battery test is canceled. Before starting the battery

test, firmly connect the power cord to the AC outlet on the wall and

the defibrillator.

• If there is a difference in temperature between the battery and the

defibrillator, the battery test cannot be done properly. In such a case

(for example, when you test the extra battery), insert the battery in

the defibrillator and leave it for 3 hours, then perform the battery test.

1. On the System Setup - Menu screen, select “Battery Test” with the Item key

and press the OK key. The System Setup - Battery Test screen appears.

2. Confirm that the battery is properly installed.

3. Connect the power cord to the AC outlet.

4. Confirm that enough recording paper is loaded in the recording unit. If not,

load it.

5. Press the START key to start the battery test.

• When the battery is not fully charged, it is charged, then discharged.

• When the battery is fully charged, it is immediately discharged.

A message shows the progress of the test.

Checking battery: Battery is being charged for the battery test.

Battery is being discharged.

Battery is being charged for the next use.

Test result XX %: Test finished.

NOTEWhen the battery temperature is high, an error message and the

battery test result appear on the screen, and the battery charging

Battery Test

10. MAINTENANCE


Reset:Press this key only when the battery pack is replaced. Referto “Inserting the Battery into the Defibrillator” in Section 2.

stops. With the power cord connected, turn the Energy/Mode Select

control to OFF to reduce the battery temperature, and make sure to

continue the battery charging for the next use. (Refer to “Error

Messages During Battery Test” table.)

To stop the battery test, press the STOP key.

6. When test finishes, the result appears on the screen.

Battery capacity is shown as 100, 80, 70, 60, 50, 40, and 0.

While the test result is displayed on the screen, you can print the test result by

pressing the Record key.

NOTE• Even when the capacity is 100 to 70%, replace a battery which has

been used for more than one year.

• When you cannot confirm the capacity (%) after battery test is done,

press the Record key to confirm that the battery test is correctly

done.

• Do not press any keys or buttons during battery test. Otherwise the

screen may switch to the setup screen by pressing the menu key.

Test result Description Action

Battery OK XXX% (Capacity XXX%:100%, 80% 70%)

Capacity is enough. Battery operation is available anytime. When the defibrillator is not used, always do trickle charging.

Battery WEAK XXX% Capacity XXX%: 60%, 50%)

Capacity has decreased under 70%.

Battery operation is available only when the battery is fully charged. The time to replace the battery is coming soon. It is recommended that the battery be replaced with a new one.

Replace battery XXX% (Capacity XXX%: 40%, 0%)

Capacity has decreased under 50%.

Only AC operation is available. Immediately replace the battery with a new one. Contact your Nihon Kohden distributor or representative.

10. MAINTENANCE


Error Messages During Battery Test

Checking the BatteryAppearance


To prevent battery trouble, check the battery appearance every 6 months. The

check schedule should be written on the battery check label attached to the

defibrillator.

1. Check the outside appearance of the battery pack. If there is any damage

(crack, deformation, cable discontinuity and so on) on the battery or the battery

leaks, replace the battery with a new one. If the battery is dirty with dust,

remove it.

If the battery check label says it is the day to replace the battery, replace the

battery with a new one.

2. After checking, change the battery check label. If the battery is replaced, write

down the date of the first use on the new battery.


Insert battery Battery test cannot be done because the battery is not inserted in the defibrillator.

First disconnect the power cord and then insert the battery into the defibrillator. Do the test again.

Connect to AC power Battery test cannot be done because AC power is not supplied to the defibrillator.

Supply AC power to the defibrillator and do the test again.

Battery discharge timed out A battery other than the specified one is used. Or defibrillator abnormality.

Battery charge timed out A battery other than the specified one is used. Or the battery is deteriorated.

Use the specified battery pack. If the message still appears, contact your Nihon Kohden distributor or representative.

Battery charging error Faulty defibrillator Contact your Nihon Kohden distributor or representative.

Battery FET Error Faulty defibrillator Contact your Nihon Kohden distributor or representative.

Battery charging stopped due to increased temperature. Turn Energy/Mode Select to OFF to charge battery

The battery temperature is high and the battery charging stops.

With the power cord connected, turn the Energy/Mode Select control to OFF, and continue the battery charging for the next use.

10. MAINTENANCE


HV Capacitor Test This checks the performance of the HV (high voltage) capacitor to charge the

defibrillation energy. During this check, the capacitor is charged and disarms.

NOTEMake sure that the AC power cord is connected to ensure the battery

charge for emergency operation.

1. On the System Setup - Menu screen, select “HV Capacitor Test” with the Item

key and press the OK key. The System Setup - HV Capacitor Test screen

appears.

2. Set the Energy/Mode Select control to 200 J.

NOTEIf the energy is not set to 200 J, HV capacitor test cannot be done.

3. Press the CHARGE button on the external paddle (APEX) or the CHARGE/

AED button on the front panel to charge energy. The defibrillator charges the

selected energy. After charging is completed, the defibrillator automatically

disarms and measures the discharge energy. The check result appears on the

screen.

NOTEDuring charging, if the Energy/Mode Select control is turned to another

position, the defibrillator immediately disarms.

4. Press the key for “Menu” to return to the System Setup-Menu screen.

Test result Description

Capacitance XXX% Capacitor test pass

100 – 80 %: Capacitor performance is OK. It can be used at any time.

Capacitance XXX% Capacitor test fail

0 – 79 %: Capacitor life is almost over. Replace it with a new one. Contact your Nihon Kohden distributor or representative.

10. MAINTENANCE


Recorder Test

Date and Time Adjustment Confirm that the date and time printed on the recording paper is correct.

If it is not correct, set the date and time on the Date/Volume screen. Refer to

Section 3.

NOTEMake sure that the date and time printed on the recording paper is

correct. The date and time on the recording paper are important parts

of the medical record.

The built-in recorder can be checked by recording the preset waveforms and

alphanumeric characters. Perform this test once a month.

NOTEMake sure that the AC power cord is connected to ensure the battery

charge for emergency operation.

1. On the System Setup - Menu screen, select “Recorder Test” with the Item and

press the OK key. The recorder starts printing the preset waveforms and

characters.

To cancel printing, press the Record key.

2. Check the printed paper. Confirm that there is no problem in printing.

Repair Parts Availability Policy

Periodical Replacement Schedule

To maintain the performance of the defibrillator, the following part must be

periodically replaced.

Battery pack, NKB-301V Every year

Pad adaptor, JC-765V (option for P-510/512 pads) Every two years

Pad adaptor, JC-755V (option for R2 pads) Every two years

Nihon Kohden Corporation (NKC) shall stock repair parts (parts necessary to

maintain the performance of the instrument) for a period of 8 years from the date of

delivery. In that period NKC or its authorized agents will repair the instrument.

This period may be shorter than 8 years if the board or part necessary for the faulty

section is not available.

10. MAINTENANCE


Storage

Before storage, clean the defibrillator, cables and paddles as described in

“Cleaning” in this section. When disposable pads or internal paddles are connected

to the defibrillator, disconnect them and connect external paddles to the

defibrillator.

Short Term Storage (Ready for Use at Any Time)

CAUTIONTo prevent overheating, leave the defibrillator lying flat and do not

cover it.

• When the defibrillator is not used, always connect it to AC power to maintain the

battery charge with trickle charging. Confirm that the AC lamp is on.

• Check the battery appearance every 6 months and do the battery test every

month.

• Store in a cool place (–20 to 35°C, –4 to 95°F). If the defibrillator is stored in

high temperature, the battery deteriorates.

Long Term Storage

• If you store the defibrillator not connected to AC power, remove the battery from

the defibrillator. Otherwise, the battery over-discharged after 1 month in the

defibrillator without AC power.

• When you store a battery outside the defibrillator, do the battery test every 6

months.

• Store the battery and defibrillator in a cool place (–20 to 35°C, –4 to 95°F). If

the battery is stored at high temperature, it deteriorates.

Defibrillator and Battery

NOTEThe operating environment must be more than 0oC. (Refer to

“Specifications” in Section 11.) Otherwise the high voltage capacitor

may get damaged. If the defibrillator was stored below –5oC, leave it

for 3 hours or more in at least 0oC before using it.

10. MAINTENANCE


CAUTION• Store the disposable pads in an environment described on the pads

package. If stored in an environment other than specified, the pads

become unusable.

• Do not put heavy thing on pads or do not bend pads. Pads get

damaged and deteriorated, and may cause burn to the patient.

• Store the disposable pads and ECG electrodes in a cool place (5 to 35°C, 41 to

95°F).

• Each pad has its own lifetime. Use the pad within its lifetime.

• Do not put heavy thing on pads and ECG electrodes. Otherwise, the gel may

flow out.

Disposable Pads and ECGElectrodes


Section 11 Reference

Specifications ................................................................................................................... 11.1

Defibrillator .................................................................................................... 11.1

Noninvasive Pacing (TEC-5531 series only) ................................................. 11.3

External Paddle (ND-552VB/VE/VK) ............................................................. 11.3

Battery .......................................................................................................... 11.3

Clock Accuracy ............................................................................................. 11.3

Environment .................................................................................................. 11.3

Safety ........................................................................................................... 11.4

Monitor .......................................................................................................... 11.4

ECG Amplifier ............................................................................................... 11.4

Recorder ........................................................................................................ 11.5

Rhythm Recognition Detector ....................................................................... 11.5

Power Requirements ..................................................................................... 11.5

Dimensions and Weight ................................................................................. 11.5

Electromagnetic Compatibility ....................................................................... 11.6

Reference ........................................................................................................................ 11.10

Standard Accessories ..................................................................................................... 11.11

Options/Consumables ..................................................................................................... 11.12

Pin Assignment ............................................................................................................... 11.14

AUX Connector of the QI-553V DSI/AUX OUT Interface Unit ................................ 11.14

General Requirements for Connecting Medical Electrical System ................................... 11.15

11. REFERENCE


Specifications

Defibrillator

Output energy (across 50 Ω) 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200 and 270 J

Energy accuracy 2 J: ±0.5 J, 3 J: ±1 J,5 to 15 J: ±2 J, 20 to 270 J: ±10%

Output waveform Biphasic, truncated exponential constant power (across 50 Ω)

Charging time

Manual modeWhen powered by AC 100V to 240V: to 270 J, maximum 5 s

to 200 J, maximum 3 sWhen powered by 90% of the rated mains voltage: to 270 J, maximum 5 sWhen powered by a fully charged new battery at 20°C ambienttemperature:

to 270 J, maximum 5 sto 200 J, maximum 3 s

After 15 discharges at 270 J with a fully charged new battery at 20°Cambient temperature:

to 270 J, maximum 5 s

When powered by 90% of the rated mains voltage or after 15 dischargesat 270 J with a fully charged new battery at 20°C ambient temperature:

Power on to 270 J, maximum 7 s

AED modeWhen powered by 90% of the rated mains voltage or after 15 dischargesat 270 J with a fully charged new battery at 20°C ambient temperature:

Power on to 270 J:typical 17 s, maximum 31 sStandby mode to 270 J:typical 15 s, maximum 29 s

Charging display Displays the charged energy value on the screen

Synchronized discharge Available

From the peak of R wave to the peak of discharge: within 60 ms

Maximum continuous charge/discharge cycles at 270 J

20 cycles: 3 cycles per minute with 1 minute cool down period after every 1 minute charge/

discharge period

15 cycles: 3 cycles per minute with no cool down period

Maximum skin-disposable pad contact impedance for energy charging: 280 Ω

Delivered energy : 270 J

First phase Second phase Load resistance (Ω) Ipk1 (A) D1 (ms) Ipk2 (A) D2 (ms) 25 67.3 3.85 15.5 3.62 50 41.1 6.35 12.7 3.62 75 29.5 8.86 11.0 3.62

100 22.9 11.4 9.81 3.62 125 18.8 13.9 8.96 3.62 150 15.9 16.4 8.29 3.62 175 13.8 18.9 7.76 3.62

11. REFERENCE


curr

ent [

A]

time [ms]

25

60

40

20

-20

0

0 2 64 8 10 12 14 16 18 20 22 24

50

60

40

20

-20

0

0 2 64 8 10 12 14 16 18 20 22 24

curr

ent [

A]

time [ms]

75

60

40

20

-20

0

0 2 64 8 10 12 14 16 18 20 22 24

curr

ent [

A]

time [ms]

100

30

20

10

-10

0

0 2 64 8 10 12 14 16 18 20 22 24

curr

ent [

A]

time [ms]

125

30

20

10

-10

0

0 2 64 8 10 12 14 16 18 20 22 24

curr

ent [

A]

time [ms]

150

30

20

10

-10

0

0 2 64 8 10 12 14 16 18 20 22 24

curr

ent [

A]

time [ms]

175

30

20

10

-10

0

0 2 64 8 10 12 14 16 18 20 22 24

curr

ent [

A]

time [ms]

11. REFERENCE


Noninvasive Pacing (TEC-5531 series only)

Pacing rate 40 to 180 pulse/min in 10 pulse/min steps

Output current 8 to 200 mA in 1, 2, 5 or 10 mA steps (Set on the System Setup screen)

Pacing modes Fixed and Demand

Maximum load resistance Outputs 200 mA across 250 Ω, 120 mA across 500 Ω

External Paddle (ND-552VB/VE/VK)

Paddle electrode size For adults: 70 ±3 × 106 ±3 (mm2)

For children: 45 ±3 × 53 ±3 (mm2)

Paddle cord length 2.0 m or more (when it is pulled by 18 N force)

Battery

Type

Ni-MH battery Nominal voltage: 12 V

Rated capacity: 2800 mAh

Capacity With fully charged new battery at 20°C ambient temperature

• Minimum 70 discharges at 270 J

• Minimum 150 minutes continuous monitoring

• Minimum 90 minutes fixed mode pacing (180 pulse/min, 200 mA)


• Minimum 50 discharges at 270 J

Clock Accuracy

At surrounding temeprature 25°C (77°F): ±3 min/month

At storage temperatures -20 to 70°C (–4 to 158°F): ±5 min/month

Environment

Operating temperature 0 to 45°C (32 to 113°F)

Operating humidity 30 to 95% (relative humidity, non-condensing)

Operating atmospheric pressure 700 to 1060 hPa

(Recording paper may jam, if it is wet.)

Storage temperature –20 to 70°C (–4 to 158°F)

Storage humidity 10 to 95% (relative humidity)

Storage atmospheric pressure 500 to 1060 hPa

11. REFERENCE


Safety

Safety standard IEC 60601-1: 1988

IEC 60601-1 Amendment 1: 1991

IEC 60601-1 Amendment 2: 1995

IEC 60601-1-2: 2001

IEC 60601-2-4: 2002

According to the type of protection against electrical shock

Battery power: INTERNALLY POWERED EQUIPMENT

AC power: CLASS I EQUIPMENT

According to the degree of protection against electrical shock

DEFIBRILLATION-PROOF TYPE BF APPLIED PART

External paddles, disposable pads, SpO2 adapter and CO

2 sensor kit

DEFIBRILLATION-PROOF TYPE CF APPLIED PART

Internal paddles, ECG connection cable

According to the degree of protection against harmful ingress of water IPX1

According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE

WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE

EQUIPMENT not suitable for use in the presence of FLAMMABLE

ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS

OXIDE

Mode of operation Continuous operation with intermittent load

: Operation at defibrillation mode

Continuous operation

: All operation except above mentioned

Monitor

Effective display area 117.2(W) × 88.4(H) mm (5.7 inch)

Sweep length 97 mm

Sweep speed 25 mm/s, 50 mm/s

Sensitivity 10 mm/1mV ±5% (sensitivity ×1)

Amplitude limit 40 mm

ECG Amplifier

Input signal PADDLE, I, II, III, aVR, aVL, aVF, V, AUX

Frequency response Through paddles: 0.5 to 20 Hz (-3 dB)

Through ECG connection cable: 0.05 to 150 Hz (-3 dB)

AUX: 0.05 to 150 Hz (-3 dB)

Input impedance Through paddles: ≥100 kΩThrough ECG connection cable: ≥ 5 MΩ(at 10 Hz 1mV)

AUX: ≥100 kΩ ±10%

CMRR ≥100 dB (against chassis ground) when AC filter is ON

AC filter Available (common with 50/60 Hz)

ON at ≥-20 dB, OFF

Pacing pulse rejection ON, OFF

External ECG input sensitivity 10 mm/V ± 5% (sensitivity ×1)

Heart rate counting range Defibrillation or monitoring mode: 15 to 300 bpm

Pacing mode: 15 to 220 bpm

11. REFERENCE


Recorder

Paper speed Real time/delayed ECG waveform recording: 50, 25 mm/s

Types of recording

Manual recording: real time/delayed waveform recording, report recording, event recording

Automatic recording: record on charging after discharge, alarm recording, periodic recording

Rhythm Recognition Detector

We evaluated the rhythm recognition detector of the TEC-5500 series defibrillator using the official electrocardiogram

database provided by AHA (American Heart Association) and MIT (Massachusetts Institute of Technology) and an

electrocardiogram database of over 3000 electrocardiograms from hospitals in Japan. According to our own

evaluation, the rhythm recognition detector of the TEC-5500 series defibrillator meets the equivalent of AAMI

standards ANSI/AAMI DF-39-1993 3.3.18.

Shockable Rhythm VF Sensitivity : ≥ 90%

Shockable Rhythm VT Sensitivity: ≥ 75%

All other Non-Shockable Rhythm Sensitivity: ≥ 95%

Power Requirements

AC

Line voltage 100 to 240 V

Line frequency 50/60 Hz (automatic switching)

Power input Intermittent load: 450 VA or less

Continuous load: 200 VA or less

DC (Battery)

Power voltage 12 V

Power consumption Intermittent load: 18 A or less

Continuous load: 4.2 A or less

Charging time 3 hours or less (with AC, with the power OFF)

Dimensions and Weight

Dimensions 290 (W) × 172 (H) × 355 (D) mm

Weight

TEC-5521 series defibrillator 6.1 kg (External paddles use, AC unit without battery)

5.3 kg (Pad adaptor use, AC unit without battery)

TEC-5531 series defibrillator 6.3 kg (External paddles use, AC unit without battery)

5.5 kg (Pad adaptor use, AC unit without battery)

11. REFERENCE


Standard

IEC 60601-1-2: 2001

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic

compatibility - Requirements and tests

IEC 60601-2-4: 2002

Medical electrical equipment - Part 2-4: Particular requirement for the safety of cardiac defibrillators

Electromagnetic Emissions/Immunity Ccompliance Level and Guidance

Electromagnetic Compatibility

Guidance and manufacturer's declaration - electromagnetic emissions The TEC-5500 series is intended for use in the electromagnetic environment specified below. The customer or the user of the TEC-5500 series should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11 Group 1

The TEC-5500 series uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

The TEC-5500 series is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer's declaration - electromagnetic immunity The TEC-5500 series is intended for use in the electromagnetic environment specified below. The customer or the user of the TEC-5500 series should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment — guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines

±2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

±1 kV differential mode ±2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% Ut (>95 % dip in Ut) for 0.5 cycles 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles

<5% Ut (>95% dip in Ut) for 0.5 cycles 40% Ut (60 % dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of the TEC-5500 series requires continued operation during power mains interruptions, it is recommended that the TEC-5500 series be powered from an uninterruptible power supply or a battery.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% Ut (>95 % dip in Ut) for 5 seconds

<5% Ut (>95 % dip in Ut) for 5 seconds

Mains power quality should be that of a typical commercial or hospital environment. If the user of the TEC-5500 series requires continued operation during power mains interruptions, it is recommended that the TEC-5500 series be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: Ut is the AC mains voltage prior to application of the test level.

11. REFERENCE


Guidance and manufacturer's declaration - electromagnetic immunity (1/2) The TEC-5500 series is intended for use in the electromagnetic environment specified below. The customer or the user of the TEC-5500 series should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Conducted RF ＩEC 61000-4-6

Requirement of IEC-60601-2-4: 3 Vrms 150 kHz to 80 MHz outside ISM bandsa

3 Vrms

Portable and mobile RF communications equipment should be used no closer to any part of the TEC-5500 series, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, c should be less than the compliance level in each frequency range. d Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people. a: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;

13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. b: The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80

MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.

c: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TEC-5500 series is used exceeds the applicable RF compliance level above, the TEC-5500 series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the TEC-5500 series.

d: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. • The JL-951T3 SpO2 adapter complies with IEC 60601-2: 1993 and it complies with IEC 60601-2: 2001 requirement

except for the item “Conducted RF”. • RRD is the abbreviation of Rhythm Recognition Detector.

11. REFERENCE


Guidance and manufacturer's declaration - electromagnetic immunity (2/2) The TEC-5500 series is intended for use in the electromagnetic environment specified below. The customer or the user of the TEC-5500 series should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Radiated RF ＩEC 61000-4-3

Requirement of IEC-60601-2-4: Correct operation of RRD: 10 V/m 80 MHz to 2.5 GHz No inadvertent energy delivery is allowed: 20 V/m 80 MHz to 2.5 GHz

3 V/m 20 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the TEC-5500 series , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P 80 to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz Additional requirement of IEC 60601-2-4 Correct operation of RRD: d = 4.0√P 80 to 800 MHz d = 7.7√P 800 MHz to 2.5 GHz No inadvertent energy delivery is allowed: d = 0.6√P 80 to 800 MHz d = 1.2√P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). b Field strengths from fixed RF transmitters, as deter mined by an electromagnetic site survey, c should be less than the compliance level in each frequency range. d Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people. a: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;

13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. b: The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80

MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.

c: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TEC-5500 series is used exceeds the applicable RF compliance level above, the TEC-5500 series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the TEC-5500 series.

d: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

11. REFERENCE


System Configuration at EMC testing

We tested that the defibrillator complies with IEC 60601-1-1: 2001 and IEC 60601-2-4: 2002 with the following

configuration. If other cables and equipments are used with the defibrillator, the defibrillator may not comply

with these standards.

Recommended separation distances between portable and mobile RF communications equipment and the TEC-5500 series

The TEC-5500 series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TEC-5500 series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TEC-5500 series as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter (m) Rated maximum output

power of transmitter (W)

150 kHz to 80 MHz outside ISM bands

d = 1.2√P

150 kHz to 80 MHz in ISM bands

d = 1.2√P

80 MHz to 800 MHz d = 4.0√P

800 MHz to 2.5 GHz d = 7.7√P

0.01 0.12 0.12 0.4 0.77 0,1 0.38 0.38 1.3 2.4 1 1.2 1.2 4.0 7.7

10 3.8 3.8 13 27 100 12 12 40 77

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;

13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. NOTE 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the

ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.

NOTE 4: These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

The equations and values in the above table show the condition that the RRD (Rhythm Recognition Detector) regulated in IEC 60601-2-4: 2002 does not receive electromagnetic interference.

Configuration at testing Cable length (m) Defibrillator, TEC-5521/5531 series - DSI interface unit, QI-552V - External paddles, ND-552V 0.406 Pad adapter, JC-765V** 3.50 ECG connection cable, BC-763V 3.30 CO2 sensor kit, TG-901T3 2.99 SO2 adapter, JL-951T3* 2.50 Finger probe, TL-201T* 1.60 Battery pack, NKB-301V (YZ-024H9) - Holter card, QM-064D - * When the SpO2 adapter and finger probe are connected to

the defibrillator, the defibrillator does not comply with the item “Conducted RF” (IEC 60601-1-2: 2001).

** When the pad adapter is connected to the defibrillator, the compliance level of the item “Radiated RF” (IEC 60601-2-4:2002) is 3 V/m.

11. REFERENCE


Reference

1. KERBER, RE, CARTER, J., KLEIN, S, et al.

Open chest defibrillation during cardiac surgery: Energy and current

requirements.

American Journal of Cardiology, 46:393-396, 1980

2. RACKER, WA, GUINN, GA, GEDDES, LA, et al.

The electrical dose for direct ventricular defibrillation in man.

Journal of Thoracic Cardiovascular Surgery, 75:224-226, 1978

3. RUBIO, PA and FARRELL, EM.

Low-energy direct defibrillation of the human heart

Annals of Thoracic Surgery, 27:32-33, 1979

11. REFERENCE


Standard Accessories

NOTEWhen you order accessories/consumables which have a supply code

No., specify the supply code No., not the model or code No.

No. Name Q’ty Model or Code No. Supply Code No.

1 Recording paper (Z-fold) 1 FQS50-2-100 A226 2 Contact gel GELAID 1 --- F015

3 Battery check label (for defibrillator)

1 6124-022441 ---

11. REFERENCE


Options/Consumables

Name Q’ty Model or Code No. Supply code No.

TEC accessory set (100V/IEC) BC-763V ECG connection cable (IEC, 3 leads) + Power cord H

1 YZ-024H3 ---

TEC accessory set (200V/IEC) BC-763V ECG connection cable (IEC, 3 leads) + Power cord N

1 YZ-024H4 ---

TEC accessory set (100V/AHA) BC-763VA ECG connection cable (AHA, 3 leads) + Power cord H

1 YZ-024H5 ---

TEC accessory set (200/AHA) BC-763VA ECG connection cable (AHA, 3 leads) + Power cord N

1 YZ-024H6 ---

ECG connection cable (IEC, 3 leads) 1 BC-763V K353A ECG connection cable (AHA, 3 leads) 1 BC-763VA K352A ECG connection cable (IEC, 5 leads) 1 BC-765V K353B ECG connection cable (AHA, 5 leads) 1 BC-765VA K352B External ECG cable 1 JC-761V L151 Connection cable 1 JC-762V L152 Connection cable 1 JC-763V L153 Pad adaptor for P-510/P-520 1 JC-765V --- Pad adaptor for R2 pads 1 JC-755V --- Battery pack NKB-301V 1 YZ-024H9 X065 Power cord type N 1 314839B L936 Power cord type H 1 186656A L935 Ground lead type E 1 544582B --- Cart 1 KD-028A --- Cart tray assembly (option for the cart) 1 DI-001A --- Recording paper (roll) 1 RQS50-2-100 A226 Paste holder kit 1set YZ-025H0 ---

Disposable ECG electrode Vitrode C 150/set --- G204 Disposable pad for adult 1set P-510 H315 Disposable pad for child 1set P-512 H316

Internal paddle electrode, 25 mm φ 1set ND-762V ---






Pediatric electrode assy, 44 mm φ 1 ND-612V --- DSI interface unit 1 QI-552V --- DSI/AUX out interface unit 1 QI-553V --- Holter card (SD memory card) 1 QM-064D ---

11. REFERENCE


CAUTIONOnly use the KD-028A cart for this defibrillator. If another cart is used,

it may tip over or the defibrillator may fall off.

The ND-762V, 763V, 764V and 765V internal paddle do not comply with IEC

60601-2-4 56.101 standard for contact area for adult use. The ND-762V internal

paddle does not comply with IEC 60601-2-4 56.101 standard for contact area for

pediatric use.

There are two types of TG-921T3 CO2 sensor kit. One complies with IEC 60601-

1-2: 2001, the other does not. CO2 sensor kits which comply with this standard

have a IEC 60601-1-2: 2001 stamp. The defibrillator only complies with this

standard used with the CO2 sensor kit which complies with this standard.

Name Q’ty Model or Code No. Supply code No.

CO2 measurement CO2 sensor kit 1 TG-901T3 P906 Airway adapter 50/set YG-101T R801 CO2 sensor kit 1 TG-921T3 P908 Nasal Adapter (for nasal breathing) 30/set YG-120T V921 Nasal Adapter (for naso-oral breathing) 30/set YG-121T V922 Nasal Adapter (for oxygen cannula adjustment) 30/set YG-122T V923 SpO2 measurement SpO2 adapter 1 JL-951T3 Y090

Finger probe BluPRO 1 TL-201T P225F

Multi-site probe BluPRO 1 TL-220T P225G Multi-site Y prove 1 TE-260T P205A

SpO2 probe (for adult) (1.6 m) BluPRO 5/pcs TL-251T P201A

SpO2 probe (for child) (1.6 m) BluPRO 5/pcs TL-252T P201B

SpO2 probe (for neonate) (1.6 m) BluPRO 5/pcs TL-253T P201C

SpO2 probe (for adult and neonate) (0.8 m) 5/pcs TL-051S P228A

SpO2 probe (for adult and neonate) (1.6 m) 5/pcs TL-052S P228B

SpO2 probe (for adult, child and infant) (0.8 m) 5/pcs TL-061S P229A

SpO2 probe (for adult, child and infant) (1.6 m) 5/pcs TL-062S P229B

Cottony tape 20 340703 P259

11. REFERENCE


Pin Assignment

AUX Connector of the QI-553V DSI/AUX OUTInterface Unit

CAUTIONConnect only the specified instrument to the defibrillator and follow


electrical shock or injury to the patient and operator, and cause fire or

instrument malfunction.

This connector is for analog ECG output.

Mating plug: 3.5 mmφ plug

Output sensitivity: 0.5 V/1 mV ±10%

Output impedance: 1kΩ or less

11. REFERENCE


General Requirements for Connecting Medical Electrical System

When more than one electrical instrument is used, there may be electrical potential

difference between the instruments. Potential difference between instruments may

cause current to flow to the patient connected to the instruments, resulting in

electrical shock (micro shock). Therefore, electrical instruments must be

appropriately installed as specified in IEC 60601-1-1.

The following is an extract from IEC 60601-1-1 “Medical electrical equipment Part

1: General requirements for safety”. For details, refer to IEC 60601-1-1 and

consult with a biomedical engineer.

Examples of combinations of MEDICAL ELECTRICAL EQUIPMENT and

non-medical electrical equipment

IEC 60601/B = IEC 60601-1 EQUIPMENT of TYPE B with PATIENT connection

IEC 60601/F = IEC 60601-1 EQUIPMENT of TYPE BF or TYPE CF (or TYPE B

without PATIENT connection)

IEC 60601/X = IEC 60601-1 EQUIPMENT of TYPE B or TYPE BF or TYPE CF

IEC XXXXX = Equipment complying with e.g. IEC 348, IEC 950 etc.

P: additional protective earth

Q: additional separating transformer

R: floating power supply

S: separation

Situation No. Equipment A Equipment B Solution

1 IEC 60601/X OK

1a IEC XXXXX

OK, if ENCLOSURE LEAKAGE CURRENT is less than 0.5 mA. If the ENCLOSURE LEAKAGE CURRENT is more than 0.5 mA: Solution Q (separating transformers).

2a IEC 60601/X IEC 60601/B OK

2b IEC 60601/F IEC XXXXX for B any one of P, Q, R

2c IEC 60601/B IEC XXXXX for A solution P for B any one of P, Q, R

3a IEC 60601/X IEC 60601/B OK

3b IEC 60601/F IEC XXXXX OK

3c IEC 60601/B IEC XXXXX for A solution P

4 see 3a, 3b, 3c

5a IEC 60601/X IEC 60601/B for A solution P or S (groundloop possible)

5b IEC 60601/X IEC XXXXX for A solution P or S (groundloop possible)

6a IEC 60601/X IEC 60601/X OK (with S)

6b IEC 60601/X IEC XXXXX OK (with S)

11. REFERENCE


Legend:

(V) = Potential difference between different localities.

> < = SEPARATION DEVICE.

PE = Protective earth.

1

2

3

4

5

6

Situation No.PATIENT

ENVIRONMENTMedically-used

roomNon-medically used

room

A

PE

A B

PE PE

A BPE PE

A BPE

PE

A BPE

PE(V)

A BPE

PE

(V)

tec5500 om e

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