mirustm controller · 2019-01-08 · 1 introduction 6 ifu, mirus controller, en-gb, n.00 1...

Technology Innovated Medicine

www.tim-gmbh.de Technologie Institut Medizin GmbH (TIM)

MIRUSTM Controller Instruction for use • Software version 2.00.00

www.tim-products.de

User Responsibility

2 IFU, MIRUS Controller, en-GB, N.00

This product will perform in conformity with the description thereof contained in these instructions for use and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked periodically. A defective product should not be used. Parts that are broken, missing, clearly worn, distorted or contaminated should be replaced immediately. Should repair or replacement become necessary contact your service organisation and return the defective device to TIM for repair. This product or any of its parts should not be repaired other than in accordance with written instructions provided by TIM. The product must not be altered without the prior written approval of TIM. The user of this product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than TIM. The product has a unit serial number (XXXD12345) with coded logic which indicates a product group code (XXX), the year of manufacture (K = 2017, L = 2018 etc.) and a sequential unit number for identification (12345). MIRUS™ and are trademarks of Technologie Institut Medizin GmbH (TIM). Other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.

0 Table of contents

IFU, MIRUS Controller, en-GB, N.00 3

0 Table of contents

1 Introduction ................................................................................ 6

1.1 Intended use ............................................................................................................ 6

1.2 Intended purpose ..................................................................................................... 6

1.3 Contraindications ..................................................................................................... 6

1.4 MIRUS System ........................................................................................................ 6

1.4.1 MIRUS Controller..................................................................................................... 7

1.4.2 Exchanger unit ......................................................................................................... 7

1.4.3 Device user interface ............................................................................................... 8

1.4.4 Colour code for the different volatile anaesthetic agents (VA) .................................. 8

1.4.5 Elements in touch screen ......................................................................................... 9

1.5 Symbols on the device ............................................................................................10

2 Safety ........................................................................................ 11

2.1 General safety instructions .....................................................................................11

2.1.1 Safe operation ........................................................................................................11

2.1.2 User qualification ....................................................................................................11

2.1.3 Monitoring ...............................................................................................................11

2.1.4 Electrical supply ......................................................................................................11

2.1.5 Responsibility of the manufacturer ..........................................................................12

2.1.6 Safety features .......................................................................................................12

2.2 Warning symbols used in the IFU ...........................................................................13

2.3 Patient safety ..........................................................................................................13

2.3.1 Monitoring ...............................................................................................................13

2.3.2 Volatile anaesthetic agents (VA) .............................................................................13

2.3.3 Control of patient relevant dosage ..........................................................................14

2.3.4 Combination of ventilators and MIRUS System ......................................................14

2.3.5 Triggering of ventilators ..........................................................................................14

2.3.6 Minimum tidal volume .............................................................................................14

2.3.7 MDI Applications .....................................................................................................15

2.3.8 Resistance of airway components ..........................................................................15

2.4 User’s and other patient’s safety .............................................................................15

2.5 Device ....................................................................................................................15

2.5.1 Accessories ............................................................................................................15

2.5.2 Positioning ..............................................................................................................16

2.5.3 Risk of electrical hazard ..........................................................................................16

2.5.4 Risk of fire ..............................................................................................................16

2.5.5 Electromagnetic compatibility .................................................................................17

2.6 Residual risk – Fail-safe mode ................................................................................17

3 Preparation ............................................................................... 18

3.1 Cleaning before first use .........................................................................................18

3.2 Connecting to mains supply ....................................................................................18

3.3 Connecting to MIRUS Reflector ..............................................................................19

3.4 Turning on ..............................................................................................................20

0 Table of contents


3.5 Filling during start-up sequence ..............................................................................22

3.6 Anomaly in start-up sequence.................................................................................24

3.7 Change to operation mode .....................................................................................25

3.8 Changing patient data .............................................................................................25

3.8.1 Changing gender ....................................................................................................26

3.8.2 Changing age, size, weight .....................................................................................27

3.9 Changing wash-in speed ........................................................................................28

3.10 Changing alarm settings .........................................................................................29

3.11 Filling and additional configurations ........................................................................30

3.11.1 Filling during operation ...........................................................................................31

3.11.2 Setting on-screen language and CO2 unit ...............................................................33

3.11.3 Setting time.............................................................................................................34

3.11.4 Service screen ........................................................................................................36

3.12 Setting MAC value (Vol%) ......................................................................................36

3.13 Connecting patient ..................................................................................................37

4 Application of VA ..................................................................... 38

4.1 Starting application .................................................................................................38

4.2 Supervise patient respiratory data ..........................................................................39

4.3 Pausing application and reactivate .........................................................................39

4.4 Stopping application ...............................................................................................40

5 Turning off controller ............................................................... 41

6 Maintenance and Cleaning ...................................................... 43

6.1 Maintenance ...........................................................................................................43

6.1.1 General Information ................................................................................................43

6.1.2 Schedule ................................................................................................................43

6.2 Cleaning .................................................................................................................44

6.2.1 General advice .......................................................................................................44

6.2.2 Cleaning the individual components .......................................................................44

6.3 Draining the reservoir .............................................................................................46

6.4 Shipping MIRUS Controller .....................................................................................46

7 Alarms and messages.............................................................. 47

7.1 Alarms ....................................................................................................................47

7.1.1 Alarm modality ........................................................................................................47

7.1.2 Low-priority alarms .................................................................................................47

7.1.3 High-priority alarms .................................................................................................48

7.1.4 Patient alarms .........................................................................................................49

7.1.5 Technical alarms ....................................................................................................50

7.2 Messages and error messages ...............................................................................52

7.2.1 During power up test ...............................................................................................52

7.2.2 During system test ..................................................................................................53

7.2.3 Reminder screen ....................................................................................................54

7.2.4 During On-Call mode ..............................................................................................54

7.2.5 During operation mode ...........................................................................................54

0 Table of contents


8 Standard values ........................................................................ 55

8.1 Alarm settings and application defaults ...................................................................55

8.2 Specification of wash-in speed parameters .............................................................56

9 Parts list .................................................................................... 57

9.1 Accessories ............................................................................................................57

9.2 Spare parts .............................................................................................................57

9.3 Service parts ...........................................................................................................57

9.4 Documents .............................................................................................................58

9.5 MIRUS Controller ....................................................................................................58

10 Technical specifications .......................................................... 59

10.1 General specifications ............................................................................................59

10.2 Controls and Ranges ..............................................................................................61

10.2.1 Agent dosage .........................................................................................................61

10.2.2 Alarm settings .........................................................................................................61

10.2.3 Patient data settings ...............................................................................................62

10.3 Performance ...........................................................................................................62

10.3.1 Agent dosage accuracy ..........................................................................................62

10.3.2 Respiratory monitoring accuracy .............................................................................62

10.3.3 Gas monitoring accuracy ........................................................................................63

10.4 Monitoring system ...................................................................................................63

11 Terms and abbreviations ......................................................... 64

12 High priority alarms ................................................................. 66

1 Introduction


1 Introduction

1.1 Intended use The MIRUS Controller is part of the MIRUS System. It is intended to be used for the application of volatile anaesthetic agents to humans with a tidal volume of ≥ 200 mL.

1.2 Intended purpose The MIRUS Controller is designed to work only in combination with the MIRUS Reflector. For hygiene safety reasons connection of the MIRUS System to a patient is only possible via the MIRUS Filter. Note: For more information about the MIRUS Reflector and the MIRUS Filter please refer to

the manufacturer’s IFU.

1.3 Contraindications Do not use the MIRUS System with

patients requiring less than 200 mL tidal volume.

patients that have a contraindication for the application of volatile anaesthetic

agents.

pure spontaneously breathing patients without a ventilator securing apnoea

back up ventilation mode.

jet or high frequency ventilation.

leaking patient airway systems, such as face mask or helmet systems.

additional filters (HME/F) or tubes that significantly increase dead space.

active humidification.

low flow anaesthesia.

1.4 MIRUS System The MIRUS System consists of three devices:

MIRUS Controller (MC) The electrical device that contains the anaesthetic agent and controls the agent delivery.

MIRUS Reflector (MR) The multi patient device connected to the MIRUS Controller, inserted into the patient’s breathing system.

MIRUS Filter (MF) The single patient device connected to the MIRUS Reflector, protecting the patient and breathing system.

http://dict.leo.org/ende?lp=ende&p=thMx..&search=contraindication

1 Introduction


1.4.1 MIRUS Controller

1.4.2 Exchanger unit

Interface receptacle

Alarm lights Fill port

Park Bay

Confirm button

Touch screen

MIRUS Reflector (Multi patient device.

Use up to 7 days)

MIRUS Filter (Single patient device.

Use up to 48 h)

Interface connector

1 Introduction


1.4.3 Device user interface

Touch screen. Operate MIRUS Controller by pressing buttons on the graphical user interface via touch sensitive screen.

Confirm button. Confirm actions performed on the touch screen display by pressing the Confirm button when flashing in anaesthetic colour within 5 seconds.

1.4.4 Colour code for the different volatile anaesthetic agents (VA)

Colour for Sevoflurane

Colour for Isoflurane

Colour for Desflurane

1 Introduction


1.4.5 Elements in touch screen

e.g. Home screen – standard operation screen

1 Status symbol Lung. Animated when patient breathing is detected.

2 Status symbol Life line. Animated when delivery is in progress, stationary when delivery is paused. Not visible when delivery is stopped.

3 Display for et VA value

4 Display for et CO2 value

5 Menu button Home (Home screen for standard operation)

6 Menu button Patient data (gender, weight, size, age)

7 Menu button MAC Pilot (setting wash-in speed)

8 Menu button Respiratory monitoring (supervising respiratory patient data)

9 Menu button Alarm settings: change setting alarm limits (et CO2 min, et CO2 max, et VA min, et VA max, Apnoe time, Alarm vol.)

10 Menu button Configurations:

Tab Filling (during operation)

Tab Setting (on-screen language, CO2 unit)

Tab Time setting (local time zone, time and date)

Tab Service (information about HW and SW version of MIRUS Controller, contact details of the manufacturer)

1 3 4

5

7

9

11

12

13 15

17

20

21

18

2

22

19

16 14

10

8

6

1 Introduction


11 Menu button Turn off (turn off device)

12 Button Stop: stops application of VA

13 Button MAC: displays unit and currently set value, setting MAC value.

14 Button Pause: pauses application of VA

15 Button Play: starts application of VA

16 Status symbol System test.

ST. System test was performed successfully.

No Test. System test is invalidated.

17 Status symbol battery: Power supply via battery (with capacity indicator) or battery is in charging mode (symbol is animated).

18 Status symbol mains supply: device is powered by mains supply.

19 Status symbol application of VA.

MAC pilot: MAC pilot active - VA is applied (animated synchronously to lifeline)

NO VA: VA application not active (stop or pause).

20 Status symbol Agent reservoir: liquid level (in anaesthetic agent colour).

21 Graphic Target reached level: current Fi/Fe ratio.

22 Status symbol Reflector: remaining allowed operation time (in anaesthetic agent colour).

Note: For more information about further symbols used on screens please refer to this IFU

and to the Additional Information (AI) of MIRUS Controller chapter 1.3.

1.5 Symbols on the device

STK label (in Germany): Indicates when the next safety check in accordance with §6 Medical Device Operator Ordinance (MPBetreibV) is required.

Warranty seal: Warranty void if seal is broken.

Note: For more information about further symbols used on the equipment please refer to the

Additional Information (AI) of MIRUS Controller chapter 1.3.

2 Safety


2 Safety

2.1 General safety instructions 2.1.1 Safe operation To ensure safe operation of the MIRUS Controller, use the system only as intended. Operators need to be familiar with these Instructions for use (IFU) prior to operating the system. Only trained operators should use this system. Always ensure compliance with the requirements of this IFU and with the local governmental or other authority’s requirements. 2.1.2 User qualification The MIRUS Controller should be operated by or on the order of a physician. The MIRUS Controller should only be operated by qualified medical personnel, to ensure adequate intervention in case of a device malfunction. 2.1.3 Monitoring The MIRUS Controller is equipped with monitoring functions that will help to observe the device situation and thereby serve to indicate changes in the parameters. Changes in the parameters can be caused by:

changes in the status of the patient

changes in the settings

adjustment and/or operation failures

defects and/or device malfunction

changes in the power supply

changes in the anaesthetic supply

An alternative for patient sedation should be present to maintain sedation in case of a device malfunction. 2.1.4 Electrical supply The MIRUS Controller is built for AC supply with electrical power from a line supply voltage of 100 to 230 VAC ± 10%, 50 to 60 Hz ± 5%. Verify your local AC line supply voltage matches the rated device’s voltage on the serial plate. The MIRUS Controller is equipped with an internal backup battery (UPS battery) that provides a defined time of operation with reduced functionality upon loss of electrical mains supply during application (refer to chapter 10.1 General specifications). This backup battery will automatically switch on, whenever mains supply is lost. A symbol on the display appears to inform the user. Note: The device should only be stored with a fully charged battery.

2 Safety


2.1.5 Responsibility of the manufacturer The manufacturer is not responsible for any functional change of the device, damage or injury to patient or operator that is caused by misuse or by disregard of the safety advice given in this instruction for use. The user or owner is responsible for the proper operation of the system, if the device is serviced, maintained or repaired by unauthorised personnel. The user or owner is responsible for the proper operation of the system if the device is misused or not used according to the instructions given in these instructions for use.

2.1.6 Safety features The following safety features are built into the MIRUS Controller to warn the operator in case of hazard to the patient. Device alarms

Control of Control for

Anaesthetic supply Internal reservoir empty, Dosage failure

Electrical energy Line supply fail, battery supply fail

Device’s control system Watchdog alarm, Device inclined

Interface control Occlusion or disconnection of Interface

MIRUS Reflector control MIRUS Reflector expiration time

CAUTION The MIRUS Reflector control is only valid for a continuous connection between MIRUS Interface plug and a powered MIRUS Controller (AC connected). A disconnection of the plug or power off of the MIRUS Controller will reset the timer.

Patient alarms

Control of Control for

Anaesthetic concentration Low and High et Sevo / et Iso / et Des

CO2 concentration Low and High et CO2

Apnoea Apnoea alarm

2 Safety


2.2 Warning symbols used in the IFU

Caution Not following this point will lead to damages to the device or the system.

Warning Not following this point will lead to patient and/or user harm.

2.3 Patient safety 2.3.1 Monitoring

WARNING For patient safety always use patient cardiovascular monitoring during operation of the MIRUS System.

Do not use the MIRUS System for spontaneous breathing patients

without an apnoea backup ventilation safety mode. For patient safety always perform a System test prior to operation. In case of a non-functioning touch screen always disable the delivery

of anaesthetic by disconnecting the MIRUS Reflector Interface plug. Always set alarm levels for et VA and et CO2 according to application

and patient. 2.3.2 Volatile anaesthetic agents (VA)

WARNING Using any other volatile anaesthetic agent than the one your MIRUS Controller is designed for can result in overdosing and serious patient injury.

Never use any bypass to the keyed filler system. This can result in overdosing and serious patient injury.

Do not switch type of volatile anaesthetic agent while treating a patient.

2 Safety


2.3.3 Control of patient relevant dosage

WARNING Always control the dosing of the volatile anaesthetic agent by measuring the dose relevant end-expiratory agent concentration (et VA).

Do not deliver any additional volatile anaesthetic agent to a breathing

system that is connected to the MIRUS System. 2.3.4 Combination of ventilators and MIRUS System

WARNING Use the MIRUS System only in combination with TIM tested ventilators (see list of compatible ventilators).

Using the MIRUS System with ventilators that are not according to

ISO 80601-2-12 or ISO 80601-2-13 could endanger the patient. Do not use the MIRUS System with jet or high frequency ventilators. Do not use the MIRUS System with a helmet or face mask ventilation

(NIV). 2.3.5 Triggering of ventilators

WARNING When having placed the MIRUS System into the patient’s breathing system ensure adequate triggering of the ventilator and readjust triggering parameter, if necessary.

2.3.6 Minimum tidal volume

WARNING Do not use the MIRUS System at ventilation settings requiring inspiratory tidal volumes < 300 mL.

Do not use the MIRUS System with additional breathing filters (HME/F)

at the y-piece or at the tube connection. Do not use tubes etc. that significantly increase dead space.

2 Safety


2.3.7 MDI Applications

WARNING Using MDI applications with the MIRUS System can result in an underdosage of the patient for a short period of time.

2.3.8 Resistance of airway components

WARNING Never use an active humidification system when operating the MIRUS System. This may result in serious increase of airway resistance.

When using the MIRUS System with an anaesthesia workstation,

never adjust the fresh gas setting to low-flow values (< 1.5 x MV). The CO2 absorption process in the rebreathing circuit may generate heat and moisture. This may result in serious increase of airway resistance.

Always monitor for possible increase in airway resistance.

2.4 User’s and other patient’s safety

WARNING You will work with volatile anaesthetic agents. To protect yourself and others, observe the volatile anaesthetic agent manufacturer’s safety instructions for handling with volatile anaesthetic agents.

Turn off volatile anaesthetic agent delivery when disconnecting the patient’s breathing system to avoid ambient pollution.

Do not use the MIRUS System in parallel to extracorporeal membrane

oxygenation (ECMO) or extracorporeal membrane decarboxylation (ECOR).

2.5 Device 2.5.1 Accessories

WARNING Use only accessories approved by the manufacturer of either the MIRUS Controller or the accessory.

2 Safety


2.5.2 Positioning

WARNING Never use the MIRUS Controller when not in a horizontal position to avoid the liquid agent entering the gas pathway.

If the MIRUS Controller has tipped over, wait for a minimum of

10 seconds to ensure no liquid is in gas pathways before applying anaesthetic agent.

Ensure the MIRUS Controller is always in a stable position.

2.5.3 Risk of electrical hazard

CAUTION Use the enclosed original line supply cable only. Make sure, that the device is not covered by any material (e.g. a

curtain) during the operation. This may interfere with the device’s cooling system.

Operate the system only according to the given specification for temperature and humidity. In case the system's temperature is higher or lower than specified, allow the system to stabilise in the specified operation temperature for one hour before operation.

Do not use the MIRUS System for intra or inner clinical transport.

Do not use the MIRUS System in an emergency / ambulance car. Do not use the MIRUS System in a helicopter or airplane.

2.5.4 Risk of fire

CAUTION Do not use materials such as Ammonium, Phenol, or Acetone to clean the device.

Do not use the MIRUS Controller when there is doubt in the proper

function of the electrical earth ground in the installation environment. Do not use the MIRUS Controller in the presence of flammable

anaesthetics.

2 Safety


2.5.5 Electromagnetic compatibility

CAUTION Do not use the MIRUS System in the presence of an MRI System.

WARNING The use of other electrical equipment, e.g. the line supply cable, may cause a higher EM-emission or may weaken the immunity of the device. This may cause a risk to the patient.

The use of other electrical equipment on or near this system may cause

interference. Verify normal operation of equipment in your configuration before connecting a patient.

2.6 Residual risk – Fail-safe mode During its operation, the MIRUS Controller is monitored by a separate safety system. In case of a failure, the safety system shifts the device to a fail-safe mode, which is safe for the patient. During the fail-safe mode there is no delivery of anaesthetic to the patient. Safe mode means:

screen is blank

no volatile anaesthetic agent is delivered

alarm lights are flashing in red

confirm button is flashing in red

audible alarm sound

To silence the audible alarm, press the Confirm button for at least 4 seconds. MIRUS Controller now turns off flashing red LEDs and stops alarm sound. To turn off the fail-safe mode disconnect mains supply and press the Confirm button again for at least 4 seconds. The red LEDs now turn off. To restart MIRUS Controller after a fail-safe mode

wait for 5 seconds,

reconnect AC supply,

re-start by pressing the Confirm button (usual start).

3 Preparation


3 Preparation

3.1 Cleaning before first use The MIRUS Controller does not come sterilised; the device has to be cleaned completely by the user before it is used clinically for the first time. Refer to chapter 6.2 Cleaning for more information.

3.2 Connecting to mains supply

Plug in power cable into the inlet on the

right side of the Controller.

Connect to AC supply.

100 to 230 VAC ± 10%, 50 to 60 Hz ± 5%.

Alarm lights turn on in green. (lights pulsate= battery charges)

Controller heats up.

3 Preparation


3.3 Connecting to MIRUS Reflector

Remove the MIRUS Reflector with

interface plug from its packaging.

Note: For further information refer to the

manufacturer’s instructions.

Remove plug from interface connector

receptacle.

Lift Park Bay clip

Place Reflector.

Insert interface plug into plug receptacle.

Ready to turn on.

3 Preparation


3.4 Turning on

Press Confirm button.

Start-up sound Alarm lights flash in sequence red,

yellow and green for visual control.

Test fail-safe mode

Confirm button and alarm lights flash in

red for approx. 3 seconds. Panic alarm

sound is heard.

Initial screen

Power up test and system test

If a problem or an error occurs, follow the

instructions on the screen

Refer to chapter 7.2 Messages and error messages for more information.

3 Preparation


Reminder screen Press OK to confirm.


On-Call mode Controller is ready for use.

To continue press one of the menu buttons on the right:

Home (standard mode)

(refer to chapter 3.7)

Patient data: gender, age, size, weight


MAC-Pilot: Change wash-in speed


Respiratory monitoring


Alarm settings: Change values of alarm limits


Configurations and filling: setting on-screen language, CO2 unit, Time zone, Date,

time. Filling during operation.


Turn off

(refer to chapter 5)

3 Preparation


3.5 Filling during start-up sequence If liquid volume level in reservoir is less than 75 mL, MIRUS Controller will require filling prior to the system test. Wait for a request to fill (message on screen) and follow the instructions. Note: For further information about the bottle adapter refer to the manufacturer's instructions.

CAUTION Only the suitable bottle adapter will match with MIRUS Controller.

CAUTION Don’t force an unsuitable adapter into the fill port.

CAUTION Double check bottle adapter colour, fill port collar colour and agent bottle colour to match dedicated volatile anaesthetic agent prior to filling.

WARNING Do not press the fill port valve manually down at any time. This will result in pressure and vapour release.

WARNING Slowly remove bottle from fill port to reduce vapour pressure to avoid ambient pollution.

WARNING Avoid spilling volatile anaesthetic agent during filling process to avoid ambient pollution.

Perform

CAUTION Do not try to open the flap manually, it could be seriously damaged.

Press Fill port flap button to open fill port flap or press Turn off button to shut down device.

3 Preparation


Button for fill port flap is light grey.


Fill port flap opens automatically.

Request for filling.

Filling:

Insert bottle with attached adapter

vertically in fill port.

Press bottle into fill port gently until a

mechanical stop is felt (spring

loaded valves open).

Reservoir is filled. Note: Device cannot be overfilled.

3 Preparation


Max. level reached Remove bottle.

Close fill port flap. Controller continues start-up sequence.

3.6 Anomaly in start-up sequence

In rare cases it can lead to an anomaly in start-up sequence.

To restart MIRUS Controller

disconnect AC supply,

wait for 5 seconds (green lights off),

reconnect AC supply,

restart by pressing the Confirm button (usual start).

3 Preparation


3.7 Change to operation mode

Press menu button Home.

Home screen

pre-set MAC value, e.g. SEVO

MAC40 = 0.5 = 0.9 Vol%

Refer to chapter 8.1 Alarm settings and

application defaults for more information

about ISO and DES.

3.8 Changing patient data

Press menu button Patient data.

Note: Changing patient data is also

possible during VA application.

Patient data pre-set:

gender: male

age: 40 years

size: 180 cm

weight: 80 kg

3 Preparation


3.8.1 Changing gender

Press button for selected gender.

Button for selected gender is light grey.

Press Confirm button to verify change.

Change completed.

3 Preparation


3.8.2 Changing age, size, weight

Press button for parameter to be changed,

e.g. age.

Button for selected parameter is light

grey.

Arrow keys are activated.

Use arrow keys to change parameter.


Change completed.

3 Preparation


3.9 Changing wash-in speed

Press menu button MAC pilot.

Note: Changing wash-in speed is also

possible during VA application.

MAC pilot

pre-set Wash-in speed:

rabbit = medium

Further options:

turtle = slow

cheetah = fast Refer to chapter 8.2 Specification of wash-in speed parameters for further information.

Press button for selected wash-in speed.

Button for selected wash-in speed is

light grey.


Change completed.

3 Preparation


3.10 Changing alarm settings

Press menu button Alarm settings.

Note: Changing alarm settings is also

possible during application of VA.

Alarm settings

pre-set alarm limits for SEVO:

et CO2 min = 20 mmHg

et CO2 max = 50 mmHg

et SEVO min = 0.5 Vol%

et SEVO max = 2.5 Vol%

Apnoe time = 60 sec

Alarm vol. = 100 % Refer to chapter 10.2.2 Alarm settings for information about ISO and DES.

Press button for parameter to be changed, e.g. et CO2 max.


grey.



3 Preparation



Change completed.

3.11 Filling and additional configurations

Press menu button Configuration

screens.

Note: Configuration is also possible

during VA application.

Options

1st tab: filling-screen

2nd tab: setting language, CO2 unit

3rd tab: setting time zone, date, time

4th tab: service screen

3 Preparation


3.11.1 Filling during operation

Filling-tab

Filling VA reservoir.

Note: Filling is also possible during VA application.

Note: During application of VA, VA delivery is maintained during filling process, as long as

internal pressure is sufficient.

WARNING Always control the et VA concentration of the patient during filling as it might decrease.

Note: Observe the warnings in chapter 3.5 Filling during start-up.

CAUTION Do not try to open the flap manually, it could be seriously damaged.

Press Fill port flap button.

Button Fill port flap is light grey. Follow instruction on screen.


Fill port flap opens automatically.

3 Preparation


Fill port flap open.

Filling:

Insert bottle with attached adapter

vertically in fill port.

Press bottle into fill port gently until a

mechanical stop is felt (spring

loaded valves open).

Note: Device cannot be overfilled.

Maximum level reached. Follow instruction on screen.

Close fill port flap.

Fill port flap closed. Reservoir filled.

3 Preparation


3.11.2 Setting on-screen language and CO2 unit

Select tab for Setting

Setting Setting on-screen language and CO2 unit pre-set:

Language = English

CO2 unit = mmHg

Press button for parameter to be changed, e.g. language.


grey.



3 Preparation



Change completed.

3.11.3 Setting time

Select tab for Time setting

Time setting Setting Time zone, date and time Pre-set:

Time zone = UTC +1h

Note: Check time zone setting and correct first if necessary.

Press button for parameter to be changed, e.g. hour.

3 Preparation



grey.




Change completed.

3 Preparation


3.11.4 Service screen

Select tab for Service

Service screen Information about SW and HW revision, the web-contact and a QR code.

3.12 Setting MAC value (Vol%)

Operation mode.

Press button MAC.

Button for MAC is light grey. Arrow keys are activated.

Use arrow keys to change MAC value.

3 Preparation



Change completed.

3.13 Connecting patient In order to connect the patient to the device you need a filter in addition to the reflector already connected to the controller (refer to chapter 1.4.2 Exchanger unit). Note: For information regarding the reflector and the filter and how to connect these

accessories with the patient and the controller please refer to the manufacturer’s instructions for use (IFU).

When the patient is connected to the

controller, the lung icon is animated and the

controller measures an et CO2 value.

4 Application of VA


4 Application of VA The following activities are all done on the Home screen (operation mode).

Home screen

(Operation mode)

4.1 Starting application

Press button Start.


VA Application active.

Animated life line at the top of the

screen (see next picture). MAC Pilot

status symbol is active.

Pause and Stop buttons activated.

After 10 minutes of no activity on the touch screen, the controller switches to snooze screen.

Note: After touching screen, controller

switches back to Home screen.

4 Application of VA


4.2 Supervise patient respiratory data

Press menu button Respiratory

monitoring.

Respiratory monitoring screen

4.3 Pausing application and reactivate

Press button Pause.

VA Application pauses.

Button Pause flashes.

Press button Pause.

VA Application active again.

4 Application of VA


4.4 Stopping application

Press button Stop.

Button Stop is light grey.


VA Application is finished. Pause and Stop buttons deactivated.

5 Turning off


5 Turning off

Note: Only if VA is not applied, the menu button Turn off is activated. Refer to chapter 4.4 Stopping application .

Press menu button Turn off.

Turn off screen

Press button Turn off.

Button Turn off is light grey.


5 Turning off


Button Turn off is coloured. Controller switches off automatically. Place Reflector in Park Bay.

Controller switched off (off mode).

6 Maintenance and Cleaning



6.1 Maintenance 6.1.1 General Information Maintenance, safety checks and maintenance measures must be performed only by the manufacturer or by qualified personnel authorized by the manufacturer.

6.1.2 Schedule

Affected part Period Performer

MIRUS Controller

Every 12 months Safety Check

Visual Inspection

Electrical Safety Test

Checking gas monitor

Checking pump

Safety Function test

Manufacturer or qualified personnel specially authorized by the manufacturer

UPS Battery pack

When not using the device, leave device connected to mains supply or connect to mains supply at least once a month for at least 24h. Replace every 2 years.


Fan filter Replace every 12 months.


VA reservoir Empty every 4 weeks. Do not re-use VA.

User / Operator

Software Manufacturer gives information as soon as software update is available.




6.2 Cleaning 6.2.1 General advice WARNING Observe the following safety precautions:

Read the material data sheet for each cleaning agent.

Wear gloves and safety glasses.

Do not breathe the fumes. CAUTION To prevent damage:

Refer to the manufacturer’s data if you have questions about a cleaning agent.

Do not use organic, halogenated or petroleum based solvents, anaesthetic agents, glass cleaner, acetone or harsh cleaning agents.

Do not use abrasive cleaning agents, such as steel wool, silver polish or silver cleaner.

Keep all liquids away from electrical parts.

Do not permit liquids to go into the equipment’s housing.

Do not autoclave any part of the MIRUS Controller.

No part of the MIRUS Controller is sterilisable. WARNING To prevent patient contamination:

Follow general hygiene requirements of your hospital.

Do not re-use single use components. 6.2.2 Cleaning the individual components MIRUS Controller surface

a. Turn off the MIRUS Controller and ensure that the mains power cord is disconnected.

b. Make sure the fill port is closed.

c. Remove MIRUS Reflector and interface plug.

d. Make sure the receptacle token is placed in the MIRUS Reflector receptacle and the receptacle is sealed.

e. Make sure the three connector tokens are placed in the communication ports and the ports are sealed.

f. Use a soft towel to clean the housing, the display and the user interface. When using fluid cleaner, use a mild detergent and do not permit liquids to penetrate the housing.



For wipe disinfection use agents with the following ingredients:

Agent Specification

Alcohol based

Containing:

Isopropyl alcohol (70% solution)

Ethyl alcohol (70% solution)

Composition of Ethyl alcohol (70%) and Isopropyl alcohol (70%)

Non-alcohol based

Containing quaternary ammonium compounds:

Didecyldimethylammoniumchloride max. 0,25 g / 100 g ready-for-use solution

Alkyl(C12-16)dimethylbenzylammoniumchloride max. 0,5 g / 100 g ready-for-use solution

For wipe disinfection TIM recommends:

Bacillol® Wipes

Dr. Schumacher® Cleanisept Wipes

Terralin® protect In addition to the main ingredients, cleaning agents and disinfectants often contain additives which can damage the materials. If in doubt, contact the supplier/manufacturer of the disinfectant/detergent. List of materials used:

Component Material

Housing Polystyrene (PS)

Alarm lights Polycarbonate (PC)

Touch Screen Polyester (PES)

Park Bay AlMgSi alloy, anodised, AlCuMg, anodised

Fill port Flap AlMgSi alloy, anodised

Seals / Covers Silicone, Polyethylene (PE), Synthetic rubber (EPDM)

Battery flap Aluminium, anodised

Screws Stainless steel

Labels Polyethylene (PE)

Housing feet Polyvinylchloride (PVC)

Fan filter Acrylonitrile butadiene styrene (ABS)

Power supply cord Acrylonitrile butadiene styrene (ABS), Polyvinylchloride (PVC)

IEC plug Polybutylene terephthalate (PBT)

Potential equalization Nickel-plated brass



WARNING Ensure that the housing and the touch screen have dried completely before reconnecting the MIRUS Controller to an electrical supply.

MIRUS Controller Fill port Always keep the fill port flap closed to avoid the entry of dust or other substances. In case the fill port needs to be cleaned use a clean and lint free cloth. Avoid using cotton swabs as they too will leave small particles and lint in the fill port. MIRUS Reflector To clean the external surfaces of the MIRUS Reflector follow the instructions for use supplied with the product. MIRUS Filter The MIRUS Filter is a single use device and should not be soaked, rinsed, washed, sterilised or treated with liquid disinfectants.

6.3 Draining the reservoir To drain the reservoir, a draining kit from the manufacturer TIM is needed (refer to chapter 9 Parts list for ordering information). Perform the draining according to the manufacturer’s guide that comes with the draining kit.

6.4 Shipping MIRUS Controller If the MIRUS Controller is to be sent, it must be cleaned and disinfected (refer to chapter 6.2 Cleaning), as well as completely emptied (refer to chapter 6.3 Draining the reservoir). Only use the original packing material to pack the MIRUS Controller:

Safety bag

Transport jacket (top and bottom frame)

MIRUS Controller box white

MIRUS Controller shipping box, 2-piece If the original packing material is not available, it can be ordered via: [email protected] Perform the packing as described in the manufacturer’s guide.

mailto:[email protected]

7 Alarms and messages



7.1 Alarms 7.1.1 Alarm modality The MIRUS Controller distinguishes between high- and low-priority alarms. Alarms only occur during operation and are shown in the following way:

Alarm lights: red or yellow alarm lights activated

On screen: red or yellow alarm bar with text, red or yellow highlighted icon

Audible alarm: alarm sound

Note: The alarm volume will escalate from 50% sound intensity up to the set volume (max.

100%) until alarm is muted.

If there is another alarm after the first alarm, the second alarm bar overlays the first alarm bar. Exception: if the further alarm is a low-priority alarm, the alarm bar of the high-priority alarm remains visible. The highlighted icons (if present by the alarms) are both recognizable. 7.1.2 Low-priority alarms

Activity Screen Alarm light Audible alarm

Alarm is active. Alarm message yellow continuous ON

Confirming the alarm by activating the alarm silence button.

Alarm message yellow, continuous OFF

Alarm bar Silence button

No highlighted icon in this example.



7.1.3 High-priority alarms

Activity Screen Alarm light Audible alarm

Alarm is active Alarm message

Start timer red, flashing ON

Confirming the alarm by pressing the alarm silence button

Alarm message

Start silence counter

(2 min).

red, continuous OFF

Alarm is still active after the “2 min” silence time

Alarm message

Timer red, flashing ON

Alarm bar Silence button

highlighted icon



7.1.4 Patient alarms

Alarm (in alphabetical order)

Priority Device action

Set condition Reset condition

Apnoea Low Alarm and stop VA delivery

No breathing activity. Breathing activity detected.

High et CO2

High Alarm

Measured et CO2 > max et CO2 for three consecutive breaths.

Measured et CO2 within the limit with the first breath.

High et VA VA = Sevo, Iso or Des

High Alarm Measured et VA > max etVA for three consecutive breaths.

Measured et VA within the limit with the first breath.

Low et CO2

High Alarm

Measured et CO2 < min et CO2 for three consecutive breaths.

Measured et CO2 within the limit with the first breath.

Low et VA VA = Sevo, Iso or Des

High Alarm Measured et VA < min et VA for three consecutive breaths.

Measured et VA within the limit with the first breath.

Low Vt

High Alarm Measured Vti < 200 mL for five consecutive breaths.

Measured Vti ≥ 200 mL with the first breath.

High Alarm and stop VA delivery

Measured Vti < 50 mL for five consecutive breaths.

Measured Vti ≥ 50 mL with the first breath.



7.1.5 Technical alarms



Set condition Reset condition by user

Device inclined.

Low Alarm and stop VA delivery.

Tilt angle > 25° for t < 30 sec.

Reposition device on level surface.

High Alarm and stop VA delivery.

Tilt angle > 25° for t ≥ 30 sec.

Dosage failed! Start VA?


Calculation problem was detected.

Restart VA delivery by pressing Play and confirm or turn off device.

Failure! Turn off.


A technical failure was detected.

Turn off device.

Fill port flap still open.

Low Alarm Fill port flap open >5 min.

Close fill port flap. High Alarm

Fill port flap open >7 min.

Heating system failed.

High Alarm No activity of the heating system could be detected.

Turn off device.

Interface disconnected.


Interface plug disconnected while in operation.

Reconnect interface plug.

Mains supply lost.

Low Alarm AC lost. Connect mains supply.

Occlusion of Interface


A gas sampling or measurement line is clocked.

Check interface for kinking. Check fresh gas flow of AWS to be min 1.5 * MV.

Overtem-

perature Low Alarm

Inner Controller

temperature > 55°C

Check fan input and

output.

Pause still active.

Low Alarm and pause VA delivery.

Delivery paused for > 2 min.

Neutralise interception by pressing Pause.

Please

replace

Reflector

promptly!

Low Alarm No valid values from

Reflector.

Replace reflector.

(System test should be

repeated as soon as

possible.)

Reflector expired.

Low Alarm Interface not released for >160 hours.

Prepare to replace or replace reflector.

Reflector soon expires.

Low Alarm MIRUS Interface not released for 144 –160 hours.

Prepare to replace or replace reflector.

Reservoir needs refill

Low Alarm Internal reservoir fill level < 60 mL

Refill reservoir.

Reservoir empty

High Alarm Internal reservoir fill level < 45 mL.

Refill reservoir.





Set condition Reset condition by user

Set date and time!

Low Alarm

When comparing the internal clock with a setpoint, a deviation was detected (e.g. after a long time without power supply)

Correct date and time.

UPS battery low

High Alarm if UPS battery is down to ≤ ¼ of capacity (2 minutes left).

Allow recharging of UPS battery.

VA

application

not active.

Low Alarm

Breathing activity

detected but VA

application is not

started by user via

Play.

Start VA application via

Play.



7.2 Messages and error messages 7.2.1 During power up test The following will be checked during power up test:

level reservoir

state of charge UPS battery

position of controller

connection to power supply

electronic components If a problem or an error is detected, follow the instructions on the screen. Depending on the instruction, one or more of the following buttons are available on the screen (after selecting press Confirm button):

Fill Port Flap

OK

Turn off


Note: For more information, refer to Additional Information (AI) of MIRUS Controller chapter

7.4.1.



7.2.2 During system test The following will be checked during system test:

position of reflector

connection of interface plug

pneumatic components

position of controller

connection to power supply If a problem or an error is detected, follow the instructions on the screen. Depending on the instruction, one or more of the following buttons are available on the screen (after selecting press Confirm button):

Repeat

OK

Turn off


Note: For more information, refer Additional Information (AI) of MIRUS Controller chapter

7.4.2.



7.2.3 Reminder screen

Verify that an alternative for patient sedation is present. Confirm by pressing OK or turn off device via Turn off button.


7.2.4 During On-Call mode

Follow request on screen.

7.2.5 During operation mode During operation mode some user activity is required

when filling the reservoir.

when turning off the controller. Follow instructions on screen. Refer to chapter 3.11.1 Filling during operation and chapter 5 Turning off for more information. Note: For more information, refer to Additional Information (AI) of MIRUS Controller chapter

7.4.5.

8 Standard values


8 Standard values

8.1 Alarm settings and application defaults

Screen Parameter Default value

Home MAC 0.5

Patient data

Gender male

Age 40 years

Ideal body weight 80 kg

Body height 180 cm

Vol. SEVO 0.9 Vol% ISO 0.6 Vol% DES 3.4 Vol%

MAC Pilot Wash-in speed medium

Alarm settings

et CO2 min 20 mmHg

et CO2 max 50 mmHg

et VA min ISO 0.3 Vol % SEVO 0.5 Vol % DES 1.7 Vol%

et VA max MAC * 2.0 (VA specific)

Apnoea time 60 seconds

Alarm volume 100%

8 Standard values


8.2 Specification of wash-in speed parameters

Volatile Anaesthetic agent Specification

Isoflurane

cheetah = Fast 2* set MAC-value

rabbit = Medium 1.5* set MAC-value

turtle = Slow 1.0* set MAC-value

max. concentration: 6 Vol%

Sevoflurane

cheetah = fast 2* set MAC

rabbit = medium 1.5* set MAC-value

turtle = slow 1.0* set MAC-value


Desflurane

cheetah = fast 1.5* set MAC-value

rabbit = medium 1.25* set MAC-value

turtle = slow 1.0* set MAC-value


9 Parts list


9 Parts list

9.1 Accessories

Description Order code

Bottle adapter Sevofluran QUIK-FIL BA-SEV-Q

Bottle adapter Sevofluran BA-SEV-K

Bottle adapter Isofluran BA-ISO-K

Bottle adapter Desfluran SAF-T-FIL BA-DES-S

MIRUS Mounting Bracket - Base MC-01-014

MIRUS Mounting Bracket - VESA arm MC-01-014-1

MIRUS Mounting Bracket - Rail (2pcs.) MC-01-014-2

9.2 Spare parts


Power supply cable DE, ES MC-01-001

Power supply cable UK MC-01-002

Power supply cable FR MC-01-003

Power supply cable IT MC-01-004

Power supply cable CH MC-01-005

Power supply cable AU MC-01-006

UPS backup battery MC-01-011

9.3 Service parts


MIRUS Draining Kit MC-01-013

MIRUS Draining kit - Spare bottle MC-01-013-1

MIRUS Event Log µSD Card MC-01-016

MIRUS Replacement filter MC-09-905

MIRUS Data cable MC-SC-DC-01

9 Parts list


9.4 Documents Documents can be ordered as printed version or accessed online on the manufacturer’s website: http://the-mirus.com/mirus-controller-instructions-for-use.html


MIRUS Controller Instruction for Use (en-GB, de, fr, it, es) and Additional Information (en-GB) CD MC-MC-IFU-ALL

9.5 MIRUS Controller


MIRUS Controller Isoflurane MC-MC-ISO

MIRUS Controller Sevoflurane MC-MC-SEV

MIRUS Controller Desflurane MC-MC-DES

http://the-mirus.com/mirus-controller-instructions-for-use.html

10 Technical specifications



10.1 General specifications

Specification Device

Physical dimensions (L x H x D) 325 x 195 x 210 mm (12.8 x 7.6 x 8.2 in.)

Weight with filled reservoir

9.0 kg (15.4 lb)

HW Options MC-MC-ISO MC-MC-SEVO MC-MC-DES

For VA Isoflurane For VA Sevoflurane For VA Desflurane

Environmental conditions Operation (filled reservoir): Temperature range for MC ISO, SEVO Temperature range for MC DES Atm. pressure range Equivalent altitude (above sea level) Humidity range

+10 to +40°C +10 to +30°C 700 to 1,060 hPa 3,000 to 0 m (9,840 to 0 ft) 10 to 90% relative, none condensing

Environmental conditions Storage with filled or empty reservoir: Temperature range Atm. pressure range Equivalent altitude (above sea level) Humidity range

-20 to +50°C 500 to 1,060 hPa 5,500 to 0 m (18,050 to 0 ft) 10 to 90% relative, none condensing

Environmental conditions Transport (empty reservoir): Temperature range Atm. pressure range Equivalent altitude (above sea level) Humidity range

-20 to +70°C 500 to 1,060 hPa 5,500 to 0 m (18,050 to 0 ft) 10 to 90% relative, none condensing

Noise level Patient/device alarms at max. setting “Panic” alarms (fail safe, mains supply lost, microcontroller watchdog error)

≤ 49 dB (A) > 66 dB (A) (tone sequence) at max. setting > 63 dB(A) (permanent tone)

Classifications CE class according to 93/42/EEC Protection class acc. to EN 60601-1 Protection type acc. to EN 60601-1 IP Code

IIb I B IP20

GMDN codes MC-MC-ISO MC-MC-SEVO MC-MC-DES

36890 36980 36979

UMDNS code MIRUS Controller 10-144

Electrical supply Nominal voltage Frequency Power consumption Grounding Internal back-up

100 to 230 VAC ± 10% 50 to 60 Hz ± 5% < 75 VA Standard ground stud Built in backup battery, backup time: 15 min.




Agent supply

Internal reservoir

Maximum capacity = 270 mL Reserve capacity = 20 mL

Status information On screen

Filling system

Proprietary filling system, agent specific according to ISO 5360

Filling capacity Maximum = 190 mL Maximum overfill protection = 250 mL

Electromagnetic compatibility (according to EN 60601-1-2)

Test parameters and limit values can be obtained from the manufacturer if required.

Display structure

Screen Touchscreen, 5.7", confirm button

Menu language English, German, French, Italian, Spanish

Applied Standards EN 1041 EN 60601-1 EN 60601-1-2 EN 60601-1-8 EN ISO 5360 EN ISO 8835-4 EN ISO 14971 EN ISO 15223-1 EN ISO 21647 EN ISO 80601-2-12 IEC 60529 IEC 62304 IEC 62366-1

Units CO2 Pressure (Paw, PEEP) VA concentration

mmHg, %, kPa mbar for German, cmH2O for all other languages Vol%



10.2 Controls and Ranges 10.2.1 Agent dosage

For Values

Isoflurane Range: MAC 0.1 to 2.0 @ MVi 3.0 to 15.0 L/min where MAC 1 = 1.15 Vol% @ age = 40

Increment: 0.1 MAC @ single taps on button 0.5 MAC @ pressing button > 1 sec

Sevoflurane Range: MAC 0.1 to 2.0 @ MVi 3.0 to 15.0 L/min where MAC 1 = 1.9 Vol% @ age = 40


Desflurane Range: MAC 0.1 to 2.0 @ MVi 3.0 to 15.0 L/min where MAC 1 = 6.7 Vol% @ age = 40


10.2.2 Alarm settings

For Values

et CO2 min. / et CO2 max. Range: 15 to 150 mmHg / 2.0 to 19.7% / 2.0 to 20.0 kPa

Increment: 1 mmHg / 0.5% / 0.5 kPa @ single taps on button 5 mmHg / 1.0% / 1.0 kPa @ pressing button > 1 sec

et ISO min. / et ISO max. Range: 0.0 to 6.0 Vol% Increment: 0.1 Vol% @ single taps on button

0.5 Vol% @ pressing button > 1 sec

et SEVO min. / et SEVO max. Range: 0.0 to 8.0 Vol%. Increment: 0.1 Vol% @ single taps on button


et DES min. / et DES max. Range: 0.0 to 18.0 Vol% Increment: 0.1 Vol% @ single taps on button


Apnoea time Range: 15 to 60 sec Increment: 5 seconds

Alarm volume Range: 50 to 100% Increment: 10% @ single taps on button



10.2.3 Patient data settings

Specification Values

Age Range: 10 to 115 years Increment: 1 year @ single taps on button

5 years @ pressing button > 1 sec

Size Range: 100 to 250 cm Increment: 5 cm @ single taps on button

10 cm @ pressing button > 1 sec

Weight Range: 15 to 125 kg (ideal body weight) Increment: 1 kg @ single taps on button

5 kg @ pressing button > 1 sec

10.3 Performance 10.3.1 Agent dosage accuracy

For Values

Isoflurane and Sevoflurane and Desflurane

+ 15% of set MAC (measured as average of MV) @ all settings - 15% of set MAC (measured as average of MV) @ Vt = 500 mL, Rate = 15 /min, I:E = 1:2, MAC = 1.0 Wash-in speed = Turtle Maximum rate = 40/min

10.3.2 Respiratory monitoring accuracy


Volumes ± 15% @ Vt 200 mL to 2000 mL (BTPS corrected, @rate < 40/min)

Pressures ± 4.0% or 2 cmH2O whichever is greater @ -10 to 100 cmH2O (@rate < 40/min)

Rate ± 1 breath per minute (@rate < 40/min)

I:E ± 25% (@rate > 40/min)



10.3.3 Gas monitoring accuracy


CO2 0 – 1 % ± 0.1% 1 – 5 % ± 0.2% 5 – 7 % ± 0.3% 7 – 10 % ± 0.5% > 10 % unspecified

Isoflurane 0 – 1 % ± 0.15% 1 – 5 % ± 0.2% > 5 % unspecified

Sevoflurane 0 – 1 % ± 0.15% 1 – 5 % ± 0.2% 5 – 8 % ± 0.4% > 8 % unspecified

Desflurane 0 – 1 % ± 0.15% 1 – 5 % ± 0.2% 5 – 10 % ± 0.4% 10 – 15 % ± 0.6% 15 – 18 % ± 1.0% > 18 % unspecified

10.4 Monitoring system


Safety monitoring

Patient Breathing activity

Alarms Apnoea

Tidal volume Low Vt

Agent dosage monitoring

Dosage start start of inspiration

Dosage end end of inspiration or end of delivered anaesthetic agent volume

Control Monitoring of applied volume of anaesthetic agent. Comparison of calculated with measured volume

Alarms Dosage failed! No delivery

Gas monitoring

Agent Isoflurane, Sevoflurane, Desflurane

Numerical data et VA

Alarms Low et VA, High et VA

Metabolic gases CO2

Numerical data et CO2

Alarms Low et CO2, High et CO2

11 Terms and abbreviations


11 Terms and abbreviations In alphabetical order:

AC alternating current

DC direct current

bpm breaths per minute

BTPS body temperature and pressure, saturated

DES Desflurane

DOGA Diffusion Optimized Gas Application Consumption optimising application of VA.

et CO2 end tidal CO2 concentration

et Des end tidal Desflurane concentration

et Iso end tidal Isoflurane concentration

et Sevo end tidal Sevoflurane concentration

et VA end tidal Volatile Anaesthetic concentration

Exp expiratory, expiration

Fe fraction expiratory VA, describes the expired concentration of VA

Fi fraction inspiratory VA, describes the inspired concentration of VA

FiDes inspiratory Desflurane concentration

FiIso inspiratory Isoflurane concentration

FiSevo inspiratory Sevoflurane concentration

FiVA set set target for the inspiratory volatile anaesthetic concentration

Flow ”airway flow”, the flow within the patient’s breathing system

HME Heat and Moisture Exchanger Disposable device to store exhaled humid water vapour and warmth and recycle it back to the patient with the next inspiration (artificial nose).

HMEF HME with bacterial/viral filter

HW x.n hardware revision number

I:E ratio between inspiratory and expiratory time

IBW Ideal Body Weight

IFU Instructions For Use

Insp inspiratory, inspiration

ISO Isoflurane

MAC

Minimum Alveolar Concentration The concentration of the vapour in the blood/expiratory lung volume that is needed to prevent movement (motor response) in 50% of subjects in response to surgical (pain) stimulus.

11 Terms and abbreviations


MACset set target Minimum Alveolar Concentration

MAC Pilot

Function to calculate the necessary amount of volatile anaesthetic gas to be added to the breathing gas of the patient, based on the measured respiratory volumes, end tidal VA concentration and the desired concentration of the volatile anaesthetic gas.

MC MIRUS Controller

MDI Metered-Dose Inhaler

MF MIRUS Filter

MR MIRUS Reflector

MV Minute Volume Breathing volume of a patient per minute.

MVe Minute Volume, expiratory; Unit: L/min

MVi Minute Volume, inspiratory; Unit: L/min

NIV Non Invasive Ventilation Ventilation with a mask or a helmet.

Ppeak highest airway pressure, measured with last breath

Paw ”Airway pressure”, the pressure within the patient’s breathing system

PEEP Positive End Expiratory Pressure within one breath, measured

PUT Power up test

Rate total number of breath per minute

Ref. stock number

SEVO Sevoflurane

SN Serial Number

ST System Test

SW x.nn.nn Software revision number

UPS Uninterruptible Power Supply

UTC Universal Time Coordinated, Primary time standard

VA volatile anaesthetic agent, to dose in gaseous state

Vt tidal volume in general

Vte expiratory tidal volume, per breath

Vti inspiratory tidal volume, per breath

Vt/kg tidal volume per kilogram body weight

12 High priority alarms



Alarm What MIRUS Controller does What to check or to do

Device inclined!

Device pauses the application and closes all valves until device is positioned on a level surface.

1. Reposition device on a level surface.

Dosage failed! Start VA?

Device stops the application. 1. Restart VA delivery by activating Play and Confirm or turn off device.

Failure! Turn off.

Device stops the application. Turn off tag becomes selectable. A major technical failure was recognised.

1. Turn off device into OFF mode (Standby).

2. Wait 5 seconds and try to start device again.

3. If during self test "Sorry…" message appears the device is seriously damaged. Call your service organisation.

Fill port flap still open!

Continues working. 1. Close Fill port flap.

Heating system failed.

Continues working. 1. Turn off device into OFF mode (Standby).

High et VA Continues working. 1. Patient okay (CO2, SpO2)? 2. Set MAC okay? 3. Alarm settings okay?

High et CO2 Continues working. 1. Ventilator settings okay? 2. Alarm settings okay? 3. Patient okay?

Interface disconnected

Device pauses the application. 1. Reconnect MIRUS Interface plug.

Low et CO2 Continues working. 1. MIRUS Interface okay? 2. Ventilator settings okay? 3. Alarm settings okay?

Low et VA Continues working. 1. Delivery active (Start button!)? 2. Alarm settings correct? 3. MRUS Interface okay?

Low Vt Continues working. 1. Patient okay? 2. Ventilator settings okay?

Vt has to be ≥ 200mL!

Occlusion of Interface

Device pauses the application. 1. MIRUS Interface bent or pinched?

2. Fresh gas flow of Anaesthesia Work Station minimum 1.5 * MV?

Reservoir empty

Continues working. 1. Refill reservoir promptly.

UPS battery low

Continues working. 1. Allow recharging of battery.

Notes



Technology Innovated Medicine

www.tim-gmbh.de Technologie Institut Medizin GmbH (TIM) www.tim-products.de

This document

MIRUSTM Controller Instruction for use English (GB) Printed in Germany © TIM GmbH All rights reserved Rev. N.00 of 03/18

Manufactured by

Technologie Institut Medizin GmbH (TIM) Erfurter Straße 9 D-56626 Andernach Germany T.: +49 (0) 2632 98 76 297 F.: +49 (0) 2632 98 76 299 [email protected] http://www.tim-gmbh.de

Instructions for use

Service calls

Support & Help

[email protected]

0044

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MEDCAPTAIN Europe B.V.

Kerkenbos 1077 T,

6546 BB Nijmegen,

The Netherlands

Phone: +31 (0)24-206 3000

Email: [email protected]