manual user compact touch xe ctt me an 140905

COMPACT TOUCH USER MANUAL Select a chapter:

Introduction I Regulatory & safety information II Technical information III Using the COMPACT TOUCH IV Maintenance V Appendix: IOL formulae

11, rue du bois joli - CS 40015 63808 Cournon dAuvergne Cedex

FRANCE Tel. : +33 (0) 473 745 745 Fax : +33 (0) 473 745 700

E-mail : [email protected] Site web: www.quantel-medical.com

2008

Directive 93/42/EEC

SEPTEMBER 2014

This QUANTEL MEDICAL equipment, including the associated software and documentation are proprietary products of QUANTEL MEDICAL under international copyright law and all rights are reserved. This manual may only be reproduced in whole or in part with written permission of QUANTEL MEDICAL. This manual is furnished for informational use only and QUANTEL MEDICAL reserves the right to modify the equipment characteristics and manual without previous notice. Photos and diagrams are not contractual. QUANTEL MEDICAL cannot be held responsible for any damage or injury which results from a failure to follow, or incorrect use of, the instructions contained in this manual. The guarantee of the equipment will be void if the equipment is opened (even partially), modified or repaired in any way by persons who are not authorized by QUANTEL MEDICAL.

Any question regarding the installation or the use of the COMPACT TOUCH system should be directed to the QUANTEL MEDICAL Service Department or to a local distributor:

International QUANTEL MEDICAL 11, rue du bois joli, 63808 Cournon dAuvergne FRANCE Tel. : +33 (0) 473 745 745 Fax : +33 (0) 473 745 700 E-mail : [email protected] Web site: www.quantel-medical.com

U.S.A. QUANTEL USA MEDICAL UNIT 601, Haggerty Lane BOZEMAN MT 59715 U.S.A. Tel : +1 888 660 6726 Fax : +1 (406) 586 2924 E-mail : [email protected] Web site www.quantel-medical.com

2014 QUANTEL MEDICAL

All rights reserved

COMPACT TOUCH User Manual

Software Version 3.02

International version

(Ref: XE_CTT_ME_AN)

September 5, 2014

User Manual Introduction

SEPTEMBER 2014 11, rue du bois joli - CS 40015

63808 Cournon dAuvergne Cedex FRANCE

Tel. : +33 (0) 473 745 745 Fax : +33 (0) 473 745 700


2008

Directive 93/42/EEC

CONTENTS REV*

1. INTRODUCTION............................................................................................................................................................. 1

2. USER MANUAL DESCRIPTION .................................................................................................................................. 1

3. USER MANUAL TERMS AND SAFETY SYMBOLS .................................................................................................. 1

4. UNPACKING THE INSTRUMENT ............................................................................................................................... 2

5. PACKING LIST ............................................................................................................................................................... 2

User manual: Introduction

XE_CTT_ME_AN_140905

Intro /1

1. INTRODUCTION The COMPACT TOUCH is a complete echography system which has four basic functions:

A scan echography for axial length measurement(option*) B scan echography for diagnosis(option*) IOL calculation Pachymetry for measurement of corneal thickness (option*)

* Some of those options require an activation keycode. Please contact QUANTEL MEDICAL or your local

distributor for details on how to order those packages and get the activation keycodes.

The COMPACT TOUCH is a user-friendly system that includes a touch-screen for user interface. All image acquisition is controlled via the touch-screen.

Setup of the COMPACT TOUCH is simple. Built on a PC board, the software is ready to use. The device can be delivered with the following configurations:

COMPACT TOUCH A: with A probe only COMPACT TOUCH B: with B probe only COMPACT TOUCH AB: with an A probe and a B probe

An optional pachymetry probe can be delivered with all configurations: COMPACT TOUCH A; COMPACT TOUCH B; COMPACT TOUCH AB.

2. USER MANUAL DESCRIPTION The User Manual is organized into the following chapters: Introduction

I Regulatory & safety information II Technical information III Using the COMPACT TOUCH IV Maintenance V Appendix: IOL formulae

3. USER MANUAL TERMS AND SAFETY SYMBOLS

WARNING

Potential hazards which, if not avoided, could result in serious injury or death

CAUTION

Potential hazards which, if not avoided, could result in minor or moderate injury and/or product damage

NOTE Significant additional information or explanation.

User manual: Introduction

XE_CTT_ME_AN_140905

Intro /2

4. UNPACKING THE INSTRUMENT The instrument is delivered in a special shockproof casing. If the instrument has been subjected to low temperature during transportation, it should not be turned on immediately after unpacking.

WARNING: If the instrument is at a temperature below 10C (50F): switching on the instrument may cause serious damage. Unpack the instrument and leave it at normal temperature for at least half a day to ensure that the internal components warm up gradually.

5. PACKING LIST Before beginning the installation, check the contents of the package against the following list: BASIC CONFIGURATION:

COMPACT TOUCH unit Power cord + Mouse + Footswitch External Power Supply 12Vdc Carrying case

COMPACT TOUCH A (XECTTA):

Basic configuration Biometry probe (Ref TP-01-b) or ProBeam probe (Ref TP-02-las) with carrying case B1 and biometry probe holder

COMPACT TOUCH B (XECTTB):

Basic configuration B1 probe (10MHz) with carrying case B1 and biometry probe holder Footswitch Mouse

COMPACT TOUCH AB (XECTTAB): COMPACT TOUCH B Biometry probe (Ref TP-01-b) or ProBeam probe (Ref TP-02-las) with carrying case

OPTIONS : Biometry probe (Ref TP-01-b) with carrying case (Ref XEAX2PRBBIO) ProBeam probe (Ref TP-02-las) with carrying case (Ref XEPRBBIOL) Handpiece for the TP-01-b Biometry probe (Ref XEAAAPAM) B1 and biometry probes holder (Ref XECTTPSD) Pachymetry option (Ref XEOPTPK) External keyboard (Ref XECLVUSBAZ and XECLVUSBQW) USB storage device (Ref XECLEUSB)

User Manual: I - Regulatory & safety information



Tel. : +33 (0) 473 745 745 Fax : +33 (0) 473 745 700


2008

Directive 93/42/EEC

CONTENTS REV*

1. INTENDED USE AND CONTRAINDICATIONS ................................................................................................... 1

2. SAFETY INFORMATION AND PRECAUTIONS ................................................................................................ 1*

2.1. General warnings and cautions information................................................................................................... 1*

2.2. Probes care / WARNINGS and CAUTIONS ..................................................................................................... 2*

2.3. How to prevent a transfer of infection ............................................................................................................. 3*

2.3.1. Pre-disinfection and disinfection procedures / Europe .................................................................. 3*

2.3.2. Pre-disinfection and disinfection procedures / USA only .............................................................. 3*

2.3.3. Finger cots ................................................................................................................................................. 3*

2.4. Precautions to take concerning wastes and elimination of device and accessories ........................... 4*

User manual: I Regulatory & safety information

XE_CTT_ME_AN_140905

I/1

1. INTENDED USE AND CONTRAINDICATIONS The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:

Visualization of the interior of the eye and the orbit by A and B scans. Axial Length measurement of the eye by ultrasonic means. Implanted IOL power calculation, using the Axial Length measurement. Measurement of corneal thickness by ultrasonic means.

2. SAFETY INFORMATION AND PRECAUTIONS

2.1. General warnings and cautions information Tissue exposure to ultrasound energy: The COMPACT TOUCH unit is designed for use in ophthalmology only. While QUANTEL MEDICAL is not aware of any reports of adverse effects from using ophthalmologic ultrasound biometry, no other use is intended or implied. The system controls limit the output energy to within the parameters specified for its intended purpose. No control of ultrasound energy is available to the user other than the duration of exposure.

WARNINGS

This device is required to be sold only by on the prescription of a physician. This device is not intended for foetal use. Disconnect AC power before cleaning the case. AC power should be disconnected every time after turning the system OFF To avoid risk of electric shock, this equipment must only be connected to supply mains with protective

earth. While using the unit, mains plug must be easily accessible. The COMPACT TOUCH IOL calculator will calculate negative IOL values if such is predicted by the

entered data. These are displayed with a minus sign (-). Do not ignore this sign! Be careful not to compress the cornea when measuring axial length. No modification of this equipment is allowed. Before adding any other equipment to the basic configuration, please refer to the:

COMPACT TOUCH User Manual: Chapter II - Technical information Section 5.4 Connections to the right and left panels

Do not modify the equipment without authorization of the manufacturer. In case the equipment is modified, appropriate inspection and testing must be conducted to ensure

continued safe use of the equipment. Only connect Medical Electrical Equipment which has been specified as some parts of the equipment or

as compatible with the equipment. The COMPACT TOUCH has to be disconnected from the telecom, IT network and/or USB accessories

during examination. Only use a network device or USB accessories that comply with IEC 60601-1 and IEC 60950 standards. When new equipment (not delivered by QUANTEL MEDICAL) is connected to the equipment (via USB,

network...), the leakage current measurements and checks have to be performed by the responsible organization with the new equipment installation: clause 16 IEC 60601-1 third edition.


XE_CTT_ME_AN_140905 I/2

Connect only power supply module provided by QUANTEL MEDICAL. Do not use flammable anesthetics product. Do not use in oxygen rich atmosphere. Some persons are extremely allergic to isopropyl alcohol.

CAUTIONS

Considering the current concern for possible unknown hazards, and despite the extremely low output intensities used in ultrasound biometry, QUANTEL MEDICAL recommends that patient exposure time during measurement be minimized.

To preserve the finish of the case, avoid the use of abrasive cleaners. If possible, clean spots before they dry.

Do not install non QUANTEL MEDICAL software onto the unit, as it may compromise the COMPACT TOUCH software. Installing non QUANTEL MEDICAL software will cause the warranty to be void. QUANTEL MEDICAL is not responsible for any errors caused by additional programs on the units hard drive.

Do not connect the unit to the Internet. The COMPACT TOUCH does not have antivirus protection. Connecting the unit to the Internet will cause the warranty to be void. QUANTEL MEDICAL is not responsible for any errors caused by connecting the COMPACT TOUCH to the Internet.

The installation of an antivirus may use computer resources that are necessary to the normal functioning of the COMPACT TOUCH unit and thus reduce the system performances. The image acquisition in real time by the COMPACT TOUCH system might be altered: risk of delays, saccades, image interruption It is up to the person who would install this type of software to set the appropriate parameters and validate that the software does not disrupt the normal functioning of the COMPACT TOUCH system (especially concerning the image acquisition).

2.2. Probes care / WARNINGS and CAUTIONS

WARNINGS If you notice a change in the probe efficiency or have any doubt about the probe integrity: contact

QUANTEL MEDICAL Service Department or your local distributor.

CAUTIONS The probes are fragile and must be handled with care. They will be damaged if dropped onto a hard

surface. The probes should never be autoclaved or subjected to excessive heat. Do not use any abrasive cleaning products or solvents that may alter the probes body aspect. If

possible, clean off stains immediately. The B-probe must not be totally immersed. : for disinfection purposes, only the tip of the probe should be

placed in liquid. Maximum immersion depth for B-probe is 5 cm. The A-scan probe can be immersed. After cleaning; rinse the end of the probe thoroughly with clean water to remove all traces of liquid used. The surfaces should then be dried with a lint-free cloth.

The ultrasound unit must be imperatively turned off before disconnecting the probes. Avoid splashing liquids onto the probe connectors.

Do not immerse the connector.


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2.3. How to prevent a transfer of infection

2.3.1. Pre-disinfection and disinfection procedures / Europe

WARNINGS

Between two patients, the probes and scleral shells must be cleaned to prevent patient-to-patient transfer of infection. QUANTEL MEDICAL recommends cleaning procedures: QUANTEL MEDICAL devices pre-disinfection and disinfection procedures. (Documentation code XE_SDE_PR_AN)

Probes & scleral shells must be disinfected prior to first use.

2.3.2. Pre-disinfection and disinfection procedures / USA only Probes must be disinfected for each patient to prevent the transmission of infection. Follow the Centers for Disease Control and Prevention (CDC) or institutional protocols for equipment sterilization. Probes must also be disinfected prior to first use. To disinfect a probe:

1. Clean the probe clean with a cloth. Ensure that all coupling medium and fluids are removed. The probe tip may be wiped with an alcohol swab prior to soaking.

2. Disinfect the probe tip. CDC protocol suggests soaking the probe tip for 5-10 minutes in one of the following solutions:

a. 70% isopropanol alcohol b. 3% hydrogen peroxide c. 1:10 dilution of chlorine bleach

3. Rinse the probe tip thoroughly in fresh water and allow to air dry.

Probes must not be heated (autoclave) or gas sterilized. Only clean the probes tip. Do not completely submerge the probe in cleaning or rinsing solutions. How to Disinfect Immersion Scleral Shells Follow the probe cleaning procedure, ensuring that the immersion shell is fully submerged in the disinfectant solution. Tubing for biometry shell is intended for single use. Shells must not be disinfected using procedures that use heat (autoclave) or gas.

2.3.3. Finger cots Finger cots are a simple way of preventing probe contamination:

WARNING

The finger cots are for a single use only and must be replaced after each patient.

Equipment: Preventive protection:

LATEX membrane Nitrile membrane (prevents allergy to LATEX)


XE_CTT_ME_AN_140905 I/4

Procedure:

1. Place a small amount of ultrasound gel on the end of the B probe.

2. Place the finger cot. The gel must ensure a good contact without air bubbles.

3. Roll down the finger cot along the probe body.

4. Ensure that there are no air bubbles under the Latex membrane.

5. Add gel to the probe tip before starting the examination.

2.4. Precautions to take concerning wastes and elimination of device and accessories

This product complies with the WEEE Directive (2012/19/EU) marking requirements. The COMPACT TOUCH is an electrical / electronic product and must not be discarded with domestic household waste

Do not dispose with domestic household wastes!

Product category: With reference to the equipment types in the WEEE Directive annex I, this product is classed as category 8 among the "Medical devices (with the exception of all implanted and infected products)". To dispose completely of the device and its accessories, contact QUANTEL MEDICAL.

User Manual:

II Technical information

SEPTEMBER 2014

11, rue du bois joli - CS 40015

63808 Cournon dAuvergne Cedex

FRANCE

Tel. : +33 (0) 473 745 745

Fax : +33 (0) 473 745 700

E-mail : [email protected]

Site web: www.quantel-medical.com

2008

2008

2008

2008

Directive 93/42/EECDirective 93/42/EECDirective 93/42/EECDirective 93/42/EEC

CONTENTSCONTENTSCONTENTSCONTENTS REV*REV*REV*REV*

1. LABELS ................................................................................................................................................................................. 1*

1.1. On the back panel ................................................................................................................................................. 1*

1.2. On the right panel .................................................................................................................................................... 2

1.3. On the left panel ...................................................................................................................................................... 2

1.4. Footswitch .............................................................................................................................................................. 3*

2. TECHNICAL SPECIFICATIONS ........................................................................................................................................... 3

2.1. Classification ............................................................................................................................................................ 3

2.2. Electrical requirements ......................................................................................................................................... 3

2.3. Compliance ............................................................................................................................................................... 4

2.4. Dimensions ............................................................................................................................................................... 4

2.5. Environmental conditions ...................................................................................................................................... 4

2.6. Echograph specifications ..................................................................................................................................... 4

2.6.1. Biometry Probe (option) ..................................................................................................................... 4

2.6.2. 10 MHz B-SCAN Probe (option) ....................................................................................................... 5

2.6.3. Pachymetry Probe (option) ............................................................................................................... 5

2.6.4. Acquisition echograms ...................................................................................................................... 5

2.6.5. Measurements accuracy .................................................................................................................. 5

2.6.6. Accuracy in IOL calculation .............................................................................................................. 5

2.6.7. Physiological limits of measurements ............................................................................................ 6

2.6.8. Data entry limits ................................................................................................................................... 7

2.7. Materials used ......................................................................................................................................................... 8

2.7.1. Housing .................................................................................................................................................. 8

2.7.2. Probes (Housing and material in contact with the patient) ....................................................... 8

2.8. Tissue Exposure to Ultrasound Energy .............................................................................................................. 8

2.8.1. ALARA section (ALARA: as low as reasonably possible) ........................................................... 8

2.8.2. Sonic values ......................................................................................................................................... 9

3. COMPACT TOUCH: EMC DATA AND GUIDELINES ..................................................................................................... 13

4. UNIT DESCRIPTION & INSTALLATION ......................................................................................................................... 17

4.1. Right Panel ............................................................................................................................................................. 17

4.2. Left Panel 18

4.3. Front Panel ............................................................................................................................................................. 19

5. Installation: technical information..................................................................................................................... 20

5.1. Probe holder assembling .................................................................................................................................... 20

5.2. Patient exam area ................................................................................................................................................. 21

5.3. Power supply ......................................................................................................................................................... 21

5.4. Connections to the right and left panels .......................................................................................................... 22

5.5. Probe connections................................................................................................................................................ 24

5.5.1. Biometry probe .................................................................................................................................. 24

5.5.2. Pachymetry Probe ............................................................................................................................. 25

5.5.3. B-probe10 MHz ................................................................................................................................ 25

5.5.4. Footswitch .......................................................................................................................................... 25

5.5.5. USB Ports ............................................................................................................................................ 26

5.5.6. Network port ...................................................................................................................................... 26

5.5.7. Handle .................................................................................................................................................. 26

User manualUser manualUser manualUser manual

II II II II Technical information Technical information Technical information Technical information

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1.1.1.1. LABELS LABELS LABELS LABELS

1.1. On the back panel

Identification label information:Identification label information:Identification label information:Identification label information:

ReReReRef.f.f.f. Labels &Labels &Labels &Labels & DescriptionDescriptionDescriptionDescription

Identification labelIdentification labelIdentification labelIdentification label

Protection against electrical shocks: the applied parts are classified as

BF Type".

IEC 60417IEC 60417IEC 60417IEC 60417----5555333333333333

IEC protection class: "Class II

IEC 60417IEC 60417IEC 60417IEC 60417----5172517251725172

Refer to the instruction manual/ booklet

ISO 7010ISO 7010ISO 7010ISO 7010----M002M002M002M002

For indoor use only.

IIIIEC 60417EC 60417EC 60417EC 60417----5957595759575957

Electrical/electronic equipment in accordance with the Directive

2012/19/EU (WEEE)

Do not dispose with domestic household wastes.

EN 50419EN 50419EN 50419EN 50419

General warning sign

ISO 7010ISO 7010ISO 7010ISO 7010----W001 GeneralW001 GeneralW001 GeneralW001 General

This label specifies the manufacturing date indication.

ISO 7000ISO 7000ISO 7000ISO 7000----2497249724972497

Federal US law labelFederal US law labelFederal US law labelFederal US law label ::::


II II II II Technical informationTechnical informationTechnical informationTechnical information

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1.2. On the right panel

Rf.Rf.Rf.Rf. Labels & DescriptionLabels & DescriptionLabels & DescriptionLabels & Description

Power supply specificationsPower supply specificationsPower supply specificationsPower supply specifications

Probes & footswitch connectors label:Probes & footswitch connectors label:Probes & footswitch connectors label:Probes & footswitch connectors label:

OptionsOptionsOptionsOptions :::: Pachymetry Pachymetry Pachymetry Pachymetry

probeprobeprobeprobe

A probeA probeA probeA probe BBBB

probeprobeprobeprobe

1.3. On the left panel

Rf.Rf.Rf.Rf. Labels & DescriptionLabels & DescriptionLabels & DescriptionLabels & Description

Standby Standby Standby Standby iconiconiconicon

USB / NETWORK connector labelUSB / NETWORK connector labelUSB / NETWORK connector labelUSB / NETWORK connector label

2 USB connectors (type 2.0)

Footswitch



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1.4. Footswitch

Rf.Rf.Rf.Rf. LabelLabelLabelLabel

IP44IP44IP44IP44 (According to IEC 60529)::::

- Protection against the penetration of foreign solid bodies of diameter 1 mm.

- Protection against splashing water.

Electrical/electronic equipment in accordance with the Directive 2012 /19 / EU (WEEE)

Do not dispose with domestic household wastes.

EN 50419EN 50419EN 50419EN 50419

2.2.2.2. TECHNICAL SPECIFICATIONSTECHNICAL SPECIFICATIONSTECHNICAL SPECIFICATIONSTECHNICAL SPECIFICATIONS

2.1. Classification

The system is intended for continuous operation and has the following classification:

Electric security classElectric security classElectric security classElectric security class EN 60 601-1 Standard

Protective classProtective classProtective classProtective class II

TypeTypeTypeType BF (protection against electrical shocks)

2.2. Electrical requirements

CAUTIONCAUTIONCAUTIONCAUTION

Only connect the power supply module provided by QUANTEL MEDICAL.

Power supplyPower supplyPower supplyPower supply External module with automatic voltage adaptation: no

selection is needed

Input voltageInput voltageInput voltageInput voltage 100-240 Vac

Single phase without earth

FrequencyFrequencyFrequencyFrequency 47-63 Hz

Mains consumptionMains consumptionMains consumptionMains consumption 70 VA

COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH consumptionconsumptionconsumptionconsumption 12 Vcc 5A

ClassClassClassClass II

ReferenceReferenceReferenceReference TR60M12

Trade MarkTrade MarkTrade MarkTrade Mark Cincon Electronics



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2.3. Compliance

STANDARDSTANDARDSTANDARDSTANDARD SUBJECTSUBJECTSUBJECTSUBJECT

IEC 60 601IEC 60 601IEC 60 601IEC 60 601----1111 Medical electrical equipment-Part 1: General requirements for basic safety and

essential performance

IEC 60 601IEC 60 601IEC 60 601IEC 60 601----1111----1111 Medical electrical equipment-Part 1: General requirements for basic safety and

essential performance

IEC 60 601IEC 60 601IEC 60 601IEC 60 601----1111----2222

Medical electrical equipment-Part 1: General requirements for basic safety and

essential performance Amendment electromagnetic compatibility requirements

and testing

IEC 60 601IEC 60 601IEC 60 601IEC 60 601----1111----6666 Medical electrical equipment-Part 1-6: General requirements for basic safety and

essential performance Amendment: usability

IEC 60 529IEC 60 529IEC 60 529IEC 60 529 Degree of protection provided by enclosure (IP code)

IEC 62 304IEC 62 304IEC 62 304IEC 62 304 Medical device software Software life-cycle processus (IEC 62A/474/CDV)

ISO 14 971ISO 14 971ISO 14 971ISO 14 971 Medical devices Application of risk management to medical devices (ISO/DIS

14971)

93/42/EEC93/42/EEC93/42/EEC93/42/EEC European Medical Device Directive

2.4. Dimensions

Width: 37,5 cm (14,76 in)

Depth: 10 cm (3,94 in)

Height: 27 cm (10,63 in)

Weight: 4,280 kg (9,44 lbs)

2.5. Environmental conditions

The temperature of the room where the device is operated must be within the following range: : : :

10 C



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II /5

2.6.2. 10 MHZ B-SCAN Probe (option)

Probe ReferenceProbe ReferenceProbe ReferenceProbe Reference B1

Sector angleSector angleSector angleSector angle 50

FrequencyFrequencyFrequencyFrequency 10 MHz

EmissionEmissionEmissionEmission----running moderunning moderunning moderunning mode Pulsed

Focal lengthFocal lengthFocal lengthFocal length 24mm to 26mm

Active diameterActive diameterActive diameterActive diameter 7.5mm

Active surfaceActive surfaceActive surfaceActive surface 44mm

Axial resolutionAxial resolutionAxial resolutionAxial resolution 0.2mm (at -6dB)

Lateral resolutionLateral resolutionLateral resolutionLateral resolution 0.6mm (at -6dB)

2.6.3. Pachymetry Probe (option)

Probe ReferenceProbe ReferenceProbe ReferenceProbe Reference P1

TypeTypeTypeType A

Ceramic FrequencyCeramic FrequencyCeramic FrequencyCeramic Frequency 20 MHz

MaterialMaterialMaterialMaterial PZT ceramic

Emission Repetition RateEmission Repetition RateEmission Repetition RateEmission Repetition Rate 5882 Hz

2.6.4. Acquisition echograms

Points in X axisPoints in X axisPoints in X axisPoints in X axis 1536

Points in Y axisPoints in Y axisPoints in Y axisPoints in Y axis 256

Electronic resolutionElectronic resolutionElectronic resolutionElectronic resolution 0.03mm at 1550m/s

2.6.5. Measurements accuracy

The accuracy is achieved by the electronic resolution: 0.03 mm


The global accuracy of the A-Scan is dependent upon:

A good alignment with the visual axis

A low pressure on cornea, especially when using the Contact Technique

2.6.6. Accuracy on IOL calculation

Display resolution on IOL power: 0.1 Diopter.

NOTENOTENOTENOTE

Using the SRK II formula, a 0.2 mm accuracy in measurement results in an IOL difference of 0.5 diopter.

Using the other 4 formulas, a 0.15 mm accuracy in measurement results in an IOL difference of 0.5

diopter.



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2.6.7. Physiological limits of measurements

Physiological limits ofPhysiological limits ofPhysiological limits ofPhysiological limits of measurementmeasurementmeasurementmeasurements (auto)s (auto)s (auto)s (auto) Minimum (mm)Minimum (mm)Minimum (mm)Minimum (mm) MaximumMaximumMaximumMaximum

(mm)(mm)(mm)(mm)

PhakicPhakicPhakicPhakic

Anterior chamber at:Anterior chamber at:Anterior chamber at:Anterior chamber at:

1532153215321532 m/sm/sm/sm/s 1.5 7

Lens thickness at 1641 m/sLens thickness at 1641 m/sLens thickness at 1641 m/sLens thickness at 1641 m/s 2.5 7

Total length = AC+L+VTotal length = AC+L+VTotal length = AC+L+VTotal length = AC+L+V 14 45

PseudoPseudoPseudoPseudo----phakicphakicphakicphakic

Anterior chamber atAnterior chamber atAnterior chamber atAnterior chamber at::::

1532153215321532 m/sm/sm/sm/s 1.5 7

Lens thickness at 1641 m/sLens thickness at 1641 m/sLens thickness at 1641 m/sLens thickness at 1641 m/s 0.5 7

Total lengthTotal lengthTotal lengthTotal length = AC+= AC+= AC+= AC+LLLL+V+V+V+V 14 45

AphakicAphakicAphakicAphakic Total length at 1532 m/sTotal length at 1532 m/sTotal length at 1532 m/sTotal length at 1532 m/s 14 45

NOTENOTENOTENOTE

These values correspond to the Automatic freezing control criteria.

On a manually frozen image, the markers being set manually there are no limits within the acquisition

depth of 60mm.



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2.6.8. Data entry limits

The COMPACT TOUCH will accept values within the ranges listed below as valid data entries.

NOTENOTENOTENOTE

Some of these are outside the range of normal ophthalmic physiological values.

ParametersParametersParametersParameters Allowable rangeAllowable rangeAllowable rangeAllowable range

Minimum Maximum

Anterior chamber, lens and vitreous velocitiesAnterior chamber, lens and vitreous velocitiesAnterior chamber, lens and vitreous velocitiesAnterior chamber, lens and vitreous velocities 500 m/s 5000 m/s

Dense cataract velocityDense cataract velocityDense cataract velocityDense cataract velocity 500 m/s 5000 m/s

PMMA, acrylic and silicon IOL velocityPMMA, acrylic and silicon IOL velocityPMMA, acrylic and silicon IOL velocityPMMA, acrylic and silicon IOL velocity 500 m/s 5000 m/s

Keratometry in millimetersKeratometry in millimetersKeratometry in millimetersKeratometry in millimeters 5 mm 13 mm

Keratometry in diopterKeratometry in diopterKeratometry in diopterKeratometry in diopter 25.0 D 68.0 D

Total Total Total Total length in IOL calculation screenlength in IOL calculation screenlength in IOL calculation screenlength in IOL calculation screen 15 mm 40 mm

Anterior chamber in IOL calculation screenAnterior chamber in IOL calculation screenAnterior chamber in IOL calculation screenAnterior chamber in IOL calculation screen 0 mm 9.9 mm

PostPostPostPost----operative ametropiaoperative ametropiaoperative ametropiaoperative ametropia -20.0 D +20.0 D

SRK A constantSRK A constantSRK A constantSRK A constant 113.00 120.59

Holladay surgeon factor calculated from AHolladay surgeon factor calculated from AHolladay surgeon factor calculated from AHolladay surgeon factor calculated from A -1.61 +2.69

HofferHofferHofferHoffer----Q ACDQ ACDQ ACDQ ACD 2.05 6.48

Binkhorst II postBinkhorst II postBinkhorst II postBinkhorst II post----op. anterior chamber depth: ACDbop. anterior chamber depth: ACDbop. anterior chamber depth: ACDbop. anterior chamber depth: ACDb 1 mm 8 mm

Constant for Haigis formula: aConstant for Haigis formula: aConstant for Haigis formula: aConstant for Haigis formula: a0000 -10 +10

Constant for Haigis formula: aConstant for Haigis formula: aConstant for Haigis formula: aConstant for Haigis formula: a1, 1, 1, 1, aaaa2222 -1 +1

Haigis constants: combined limits for a (1.16 to 7mm) Haigis constants: combined limits for a (1.16 to 7mm) Haigis constants: combined limits for a (1.16 to 7mm) Haigis constants: combined limits for a (1.16 to 7mm)

ACD rangeACD rangeACD rangeACD range

-2 < a0 + 3.37 a1 + 23.39 a2 < 12

-2 < a0 + 2.53 a1 + 20.00 a2 < 12

-2 < a0+ 3.50 a1 + 27.00 a2 < 12



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2.7. Materials used

2.7.1. Housing

Upper frameUpper frameUpper frameUpper frame Polyurethane plastic complying with the UL 94 V0 standard

Lower frameLower frameLower frameLower frame Painted steel sheet

LCD LCD LCD LCD LED LED LED LED front panelfront panelfront panelfront panel Painted steel sheet

2.7.2. Probes (Housing and material in contact with the patient)

AAAA----ScanScanScanScan Body material Delrin 100

Face material Insulcast I-124 Epoxy

Manufacturer Permagile

PachymetryPachymetryPachymetryPachymetry Body material Delrin 100

Face material REXOLITE 1422

Manufacturer Blatek

BBBB----ScanScanScanScan Body material Painted aluminium

Face material TPX-MX002

Manufacturer Mitsui

2.8. Tissue Exposure to Ultrasound Energy

The COMPACT TOUCH unit is designed for use in ophthalmology only.

WARNINGWARNINGWARNINGWARNING

This device is not intended for foetal use.

2.8.1. ALARA section (ALARA: as low as reasonably possible)

Ultrasound energy will always be attenuated by the tissue between the transducer and the focus when

used as recommended. The values presented here are the values at the focal point, the point of

maximum intensity.

It is not possible to vary the output energy of the transducer. However, to minimize exposure,

measurements should be kept as short as possible.

If more accuracy is desired, the intensity in the body at any transducer point may be calculated

according to the formula recommended by the FDA:

IIIIt t t t = I= I= I= Iwwwwexp(exp(exp(exp(----0.069fz)0.069fz)0.069fz)0.069fz)

Where:

IIIItttt = is the estimated in situ intensity

IIIIwwww is the measured intensity in water at the focus of the transducer

ffff is the ultrasonic frequency in megahertz

zzzz is the distance from the face of the probe to the transducer focus in centimeters, which is the point of

measurement

This formula was also used to calculate the derated values shown above.



XE_CTT_ME_AN_140905

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2.8.2. Sonic values

Transducer parameters show considerable variation from transducer to transducer. The measured and

calculated values given in the sections below (2.8.2.1 / 2.8.2.2 / 2.8.2.3) were those for 3 actual

transducers, whose values deviated slightly from the values in the specification above, and whose

values are likely to be different from the transducer of the users system. However, the values in the

specification should give results that are accurate enough for any practical purpose, since the

intensities are very low.

CAUTION:CAUTION:CAUTION:CAUTION:

It is always recommended to minimize exposure by limiting the ultrasonic transmission to as short

periods as possible.

Symbols used in the following tables are described below:

IIIISPTA.SPTA.SPTA.SPTA.

3333

The derated spatial-peak temporal-average intensity (milliwatts per square centimeter).

IIIISPPA.SPPA.SPPA.SPPA.

3333

The derated spatial-peak pulse-average intensity (watts per square centimeter). The value of IPA.3

at the position of global maximum MI (IPA.3@MI) may be reported instead of ISPPA.3 if the global

maximum MI is reported.

MlMlMlMl The Mechanical Index. The value of MI at the position of ISPPA 3, ([email protected]) may be reported

instead of MI (global maximum value) if ISPPA.3 is < 190W/cm2.

PPPPR.3R.3R.3R.3 The derated peak rarefactional pressure (megapascals) associated with the transmit pattern giving

rise to the value reported under MI.

WWWWoooo The ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, Wo is the total

time-average power; for the operating condition subject to reporting under ISPPA.3, , , , W0 is the

ultrasonic power associated with the transmit pattern giving rise to the value reported under

ISPPA.3....

ffffcccc The center frequency (MHz). For Ml and ISPPA.3 , fc is the center frequency associated with the

transmit pattern giving rise to the global maximum value of the respective parameter. For ISPTA.3 ,

for combined modes involving beam types of unequal center frequency, fc is defined as the overall

range of center frequencies of the respective transmit patterns.

zzzzSPSPSPSP The axial distance at which the reported parameter is measured (centimeters).

xxxx----6,6,6,6, yyyy----6666 Are respectively the in-plane (azimuthal) and out-of-plane (elevational) -6dB dimensions in the x-y

plane where zsp is found (centimeters).

PDPDPDPD Pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value

of the respective parameter.

PRFPRFPRFPRF Pulse repetition frequency (Hz) associated with the transmit pattern giving rise to the reported

value of the respective parameter.

EBDEBDEBDEBD Entrance beam dimensions for the azimuthal and elevational planes (centimeters).

EDSEDSEDSEDS Entrance dimensions of the scan for the azimuthal and elevational planes (centimeters).



XE_CTT_ME_AN_140905

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2.8.2.1. A-Scan probe (option)

Probe referenceProbe referenceProbe referenceProbe reference TP-01-b / TP-02-las (ProBeam)

TypeTypeTypeType A-scan



Ultrasonic intensities in tissue at measured transducer focus (22mm from probe tip).

IIIISPTA.3SPTA.3SPTA.3SPTA.3 0.140 mW/cm2

IIIISPPA.3SPPA.3SPPA.3SPPA.3 11.611 W/cm2

Mechanical Mechanical Mechanical Mechanical indexindexindexindex 0.16

Ultrasonic powerUltrasonic powerUltrasonic powerUltrasonic power 0.013 mW

Transducer modelTransducer modelTransducer modelTransducer model TP-01-b / TP-02-las (ProBeam)

Operating ModeOperating ModeOperating ModeOperating Mode A-Scan

ApplicationApplicationApplicationApplication Ophthalmic biometer

Acoustic outputAcoustic outputAcoustic outputAcoustic output MIMIMIMI IIIISPSPSPSPTTTTA.3A.3A.3A.3

(mW/ cm(mW/ cm(mW/ cm(mW/ cm2222))))

IIIISPPA.3SPPA.3SPPA.3SPPA.3

(W/ cm(W/ cm(W/ cm(W/ cm2222))))

Maximum ValueMaximum ValueMaximum ValueMaximum Value 0.16 0.140 11.611

Ass

ociated A

coustic

Ass

ociated A

coustic

Ass

ociated A

coustic

Ass

ociated A

coustic

Para

meters

Para

meters

Para

meters

Para

meters

Pr.3 (Mpa) 0.480

W0 (mW) 0.013 0.013

fc (MHz) 8.83 8.83 8.83

Zsp (cm) 2.00 2.00 2.00

Beam

Dimension

X-6 (cm) 0.168 0.168

Y-6 (cm) 0.166 0.166

PD (m) 0.11 0.126

PRF (Hz) 108 108

EBD Az (cm) 0.5

E1 (cm) 0.5



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2.8.2.2. B-Scan probe (option)

Probe referenceProbe referenceProbe referenceProbe reference B1

TypeTypeTypeType B mode

MaterialMaterialMaterialMaterial Composite material


Pulse repetition frequencyPulse repetition frequencyPulse repetition frequencyPulse repetition frequency 4655 Hz

Ultrasonic intensities in tissue at measured transducer focus (27mm from probe tip):



Mechanical indexMechanical indexMechanical indexMechanical index 0.196


Transducer modelTransducer modelTransducer modelTransducer model 10 MHz Ophthalmic Probe

Operating ModeOperating ModeOperating ModeOperating Mode B-mode

ApplicationApplicationApplicationApplication Ophthalmic




(W/ cm(W/ cm(W/ cm(W/ cm2222))))


Ass

ociated A

coustic

Ass

ociated A

coustic

Ass

ociated A

coustic

Ass

ociated A

coustic

Para

meters

Para

meters

Para

meters

Para

meters

Pr.3 (Mpa) 0.56

W0 (mW) 0.208 0.208

fc (MHz) 8.85 8.85 8.85

Zsp (cm) 2.7 2.7

Beam

Dimension

X-6 (cm) 0.094

Y-6 (cm) 0.09

PD (s) 0.09 0.09

PRF (Hz) 2844 2844

EBD Az (cm) 1.41

Ele (cm) 0.75



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2.8.2.3. Pachymeter probe

Probe referenceProbe referenceProbe referenceProbe reference P1

TypeTypeTypeType A

Tip diameterTip diameterTip diameterTip diameter 1.2mm

Active tip diameterActive tip diameterActive tip diameterActive tip diameter 1.5mm

Focal pointFocal pointFocal pointFocal point 0.5mm from the tip


Ceramic frequencyCeramic frequencyCeramic frequencyCeramic frequency 20MHz

AngleAngleAngleAngle 45 degrees

Ultrasonic intensities in tissue at measured transducer focus (2mm from probe tip).



MechanicalMechanicalMechanicalMechanical IndexIndexIndexIndex 0.04


Transducer modelTransducer modelTransducer modelTransducer model Pachymeter

Operating modeOperating modeOperating modeOperating mode A-Scan

ApplicationApplicationApplicationApplication Ophthalmic Pachymeter




(W/ cm(W/ cm(W/ cm(W/ cm2222))))


Ass

ociated A

coustic

Ass

ociated A

coustic

Ass

ociated A

coustic

Ass

ociated A

coustic

Para

meters

Para

meters

Para

meters

Para

meters

Pr.3 (Mpa) 0.15

W0 (mW) 0.0009 0.0009

fc (MHz) 13.14 13.14 13.14

Zsp (cm) 0.200 0.200 0.200

Beam

Dimension

X-6 (cm) 0.100 0.100

Y-6 (cm) 0.104 0.104

PD (s) 0.05 0.05

PRF (Hz) 2800 2800

EBD Az (cm) 0.12

E1 (cm) 0.12

Accuracy in pachymetry modeAccuracy in pachymetry modeAccuracy in pachymetry modeAccuracy in pachymetry mode ::::

The least-significant digit of the display is one micron. However, the accuracy of the measurements is

5 microns, over a range of corneal thicknesses from 200 to 999 microns. The maximum acoustic

resolution (the ability to distinguish two separate echos) is 81 microns, and is limited by the central

frequency of the imaging transducer. For structures larger than 200 microns, the reproducibility of the

measurements is actually 5 microns. It does not include errors caused by operation or uncertainty in

the velocity of sound.

The operator should minimize errors by keeping the probe perpendicular to the cornea and The operator should minimize errors by keeping the probe perpendicular to the cornea and The operator should minimize errors by keeping the probe perpendicular to the cornea and The operator should minimize errors by keeping the probe perpendicular to the cornea and

applying as little pressure as possible.applying as little pressure as possible.applying as little pressure as possible.applying as little pressure as possible.



XE_CTT_ME_AN_140905

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The default value of sound velocity, 1620 m/s, is considered to be the most standard value of velocity in

the cornea. Other values can only be used if they are specifically documented for the type of eye under

treatment.

NOTENOTENOTENOTE

It is not recommended to modify the value of velocity in cornea.

The accuracy of the emissions given in the table above is: Power 29%, Pressure 14.6%, Intensities 29%,

Center frequency 2%, as defined by the spectrum of the pulse.

3.3.3.3. COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH: EMC DATA AND GUIDELINES: EMC DATA AND GUIDELINES: EMC DATA AND GUIDELINES: EMC DATA AND GUIDELINES


Medical electrical equipment needs special precautions regarding EMC. The following EMC guidelines

must be observed during installation and commissioning of the COMPACT TOUCH.


Portable and mobile RF communications equipment can affect medical electrical equipment.

Guidance and manufacturers declaration Guidance and manufacturers declaration Guidance and manufacturers declaration Guidance and manufacturers declaration electromagnetic emissionselectromagnetic emissionselectromagnetic emissionselectromagnetic emissions

The The The The COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH is intended for use in the electromagnetic environment specified below. The is intended for use in the electromagnetic environment specified below. The is intended for use in the electromagnetic environment specified below. The is intended for use in the electromagnetic environment specified below. The

operator of the operator of the operator of the operator of the COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH has to make sure that it is used in such an environment.has to make sure that it is used in such an environment.has to make sure that it is used in such an environment.has to make sure that it is used in such an environment.

Emission testEmission testEmission testEmission test ComplianceComplianceComplianceCompliance Electromagnetic environment Electromagnetic environment Electromagnetic environment Electromagnetic environment ----

GuidanceGuidanceGuidanceGuidance

RF emission acc. toRF emission acc. toRF emission acc. toRF emission acc. to

EN 55011EN 55011EN 55011EN 55011

Group 1 The COMPACT TOUCH uses RF energy

only for its internal functions.

Therefore, its RF emissions are very

low and are not likely to impair nearby

electronic equipment.

RF emissions acc. to RF emissions acc. to RF emissions acc. to RF emissions acc. to

EN 55011EN 55011EN 55011EN 55011

Class A The COMPACT TOUCH is suitable in all

establishments other than those in

living areas and those directly

connected to the public low voltage

power supply network that also

supplies buildings used for living.

Harmonic emissions acc. toHarmonic emissions acc. toHarmonic emissions acc. toHarmonic emissions acc. to

IEC 61000IEC 61000IEC 61000IEC 61000----3333----2222

Class A

Voltage fluctuations / Voltage fluctuations / Voltage fluctuations / Voltage fluctuations /

Flicker emissions acc. toFlicker emissions acc. toFlicker emissions acc. toFlicker emissions acc. to

IEC 61000IEC 61000IEC 61000IEC 61000----3333----3333

Complies



XE_CTT_ME_AN_140905

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Guidance and manufacturer declaration Guidance and manufacturer declaration Guidance and manufacturer declaration Guidance and manufacturer declaration electromagnetic immunityelectromagnetic immunityelectromagnetic immunityelectromagnetic immunity

The The The The COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator

of the of the of the of the COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH has to ensure that it is used in such an environment.has to ensure that it is used in such an environment.has to ensure that it is used in such an environment.has to ensure that it is used in such an environment.

Immunity Immunity Immunity Immunity

TestTestTestTest

CEI 60601 test CEI 60601 test CEI 60601 test CEI 60601 test

levellevellevellevel

Compliance Compliance Compliance Compliance

levellevellevellevel Electromagnetic environment Electromagnetic environment Electromagnetic environment Electromagnetic environment ---- GuidanceGuidanceGuidanceGuidance

Portable and mobile RF communications equipment should

be used no closer to any part of the COMPACT TOUCH,

including cables, than the recommended separation

distance calculated from the equation applicable to the

frequency of the transmitter.

RecommendedRecommendedRecommendedRecommended separation distance:separation distance:separation distance:separation distance:

Conducted Conducted Conducted Conducted

RF RF RF RF

disturbances disturbances disturbances disturbances

according to according to according to according to

IEC 61000IEC 61000IEC 61000IEC 61000----4444----6666

3 Veff

150 kHz to 80

MHz

10 V

Pd 35,0=

Radiated RF Radiated RF Radiated RF Radiated RF

disturbances disturbances disturbances disturbances

according to according to according to according to

IEC 61000IEC 61000IEC 61000IEC 61000----4444----3333

3 V/m

80 MHz to 2,5

GHz

10 V/m

Pd 35,0= for 80 MHz to 800 MHz

Pd 7,0= for 800 MHz to 2,5 GHz

Where P is the maximum emission output power of the

transmitter in watts (W) according to the transmitter

manufacturer and d is the recommended separation

distance in meters (m).

Field strength from fixed RF transmitters, as determined by

an electromagnetic site surveya, should be less than the

compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked

with the following symbol:

NOTE 1: At 80 MHz and 800 MHz the separation distance for the NOTE 1: At 80 MHz and 800 MHz the separation distance for the NOTE 1: At 80 MHz and 800 MHz the separation distance for the NOTE 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.higher frequency range applies.higher frequency range applies.higher frequency range applies.

NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, and reflection from structures, and reflection from structures, and reflection from structures, objects and people.objects and people.objects and people.objects and people. aaaa Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and land mobile Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and land mobile Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and land mobile Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and land mobile

radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with

accuracy. To asaccuracy. To asaccuracy. To asaccuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site sess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site sess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site sess 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 device survey should be considered. If the measured field strength in the location in which the device survey should be considered. If the measured field strength in the location in which the device survey should be considered. If the measured field strength in the location in which the device COMPACT COMPACT COMPACT COMPACT

TOUCHTOUCHTOUCHTOUCH is used exceeds the applicable RF compliance level abovis used exceeds the applicable RF compliance level abovis used exceeds the applicable RF compliance level abovis used exceeds the applicable RF compliance level above, additional measures may be necessary, e, additional measures may be necessary, e, additional measures may be necessary, e, additional measures may be necessary,

such as reorientation or relocating the such as reorientation or relocating the such as reorientation or relocating the such as reorientation or relocating the COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH. In case unusual performance is witnessed, . In case unusual performance is witnessed, . In case unusual performance is witnessed, . In case unusual performance is witnessed,

additional measures may be required such as change of orientation or location of the additional measures may be required such as change of orientation or location of the additional measures may be required such as change of orientation or location of the additional measures may be required such as change of orientation or location of the COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH.... bbbb Field strengtField strengtField strengtField strength should be less than 3 V/m in the range between 150 kHz and 80 MHzh should be less than 3 V/m in the range between 150 kHz and 80 MHzh should be less than 3 V/m in the range between 150 kHz and 80 MHzh should be less than 3 V/m in the range between 150 kHz and 80 MHz



XE_CTT_ME_AN_140905

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Recommended separation distances between portable and mobile RF communications equipment and the Recommended separation distances between portable and mobile RF communications equipment and the Recommended separation distances between portable and mobile RF communications equipment and the Recommended separation distances between portable and mobile RF communications equipment and the

COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH

The The The The COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH is intended for use in an electromagnetic environment in which the radiated RF is intended for use in an electromagnetic environment in which the radiated RF is intended for use in an electromagnetic environment in which the radiated RF is intended for use in an electromagnetic environment in which the radiated RF

disturbances are controlled. The disturbances are controlled. The disturbances are controlled. The disturbances are controlled. The COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH user can help prevent electromagnetic interference by user can help prevent electromagnetic interference by user can help prevent electromagnetic interference by user can help prevent electromagnetic interference by

maintaining a minimal distance between portable and mobile RF communicationmaintaining a minimal distance between portable and mobile RF communicationmaintaining a minimal distance between portable and mobile RF communicationmaintaining a minimal distance between portable and mobile RF communications equipment (transmitters) and s equipment (transmitters) and s equipment (transmitters) and s equipment (transmitters) and

the the the the COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH as recommended below, according to the maximum output power of the as recommended below, according to the maximum output power of the as recommended below, according to the maximum output power of the as recommended below, according to the maximum output power of the

communications equipment.communications equipment.communications equipment.communications equipment.

Maximum transmitter Maximum transmitter Maximum transmitter Maximum transmitter

power output (W)power output (W)power output (W)power output (W)

Separation distance according to the transmitters frequency (m)Separation distance according to the transmitters frequency (m)Separation distance according to the transmitters frequency (m)Separation distance according to the transmitters frequency (m)

150 150 150 150 kHz to 80 MHzkHz to 80 MHzkHz to 80 MHzkHz to 80 MHz

Pd 35,0=

80 MHz to 800 MHz80 MHz to 800 MHz80 MHz to 800 MHz80 MHz to 800 MHz

Pd 35,0=

800 MHz to 2,5GHz800 MHz to 2,5GHz800 MHz to 2,5GHz800 MHz to 2,5GHz

Pd 7,0=

0,010,010,010,01 0,035 0,035 0,07

0,10,10,10,1 0,11 0,11 0,22

1111 0,35 0,35 0,70

10101010 1,1 1,1 2,2

100100100100 3,5 3,5 7,0

For transmitters rated at a maximum output power not listed above, the recommended separation distance For transmitters rated at a maximum output power not listed above, the recommended separation distance For transmitters rated at a maximum output power not listed above, the recommended separation distance For transmitters rated at a maximum output power not listed above, the recommended separation distance dddd

in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where PPPP is is is is

the maximum emission output power of the the maximum emission output power of the the maximum emission output power of the the maximum emission output power of the transmitter in watts (W) according to the transmitter transmitter in watts (W) according to the transmitter transmitter in watts (W) according to the transmitter transmitter in watts (W) according to the transmitter

manufacturer.manufacturer.manufacturer.manufacturer.

NOTE 1 : Between 80 MHz and 800 MHz, separation distance for the highest frequency range appliesNOTE 1 : Between 80 MHz and 800 MHz, separation distance for the highest frequency range appliesNOTE 1 : Between 80 MHz and 800 MHz, separation distance for the highest frequency range appliesNOTE 1 : Between 80 MHz and 800 MHz, separation distance for the highest frequency range applies

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by affected by affected by affected by

absorption and reflection from structures, objects and people.absorption and reflection from structures, objects and people.absorption and reflection from structures, objects and people.absorption and reflection from structures, objects and people.



XE_CTT_ME_AN_140905

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Guidance and manufacturer declaration Guidance and manufacturer declaration Guidance and manufacturer declaration Guidance and manufacturer declaration electromagnetic immunityelectromagnetic immunityelectromagnetic immunityelectromagnetic immunity

The The The The COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator

of the of the of the of the COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH has to ensure that it is used in such an environment.has to ensure that it is used in such an environment.has to ensure that it is used in such an environment.has to ensure that it is used in such an environment.

Immunity TestImmunity TestImmunity TestImmunity Test CEI 60601 test levelCEI 60601 test levelCEI 60601 test levelCEI 60601 test level Compliance levelCompliance levelCompliance levelCompliance level Electromagnetic environment Electromagnetic environment Electromagnetic environment Electromagnetic environment ----

GuidanceGuidanceGuidanceGuidance

Electrostatic Electrostatic Electrostatic Electrostatic

discharge (ESD) discharge (ESD) discharge (ESD) discharge (ESD)

acc. to IEC 61000acc. to IEC 61000acc. to IEC 61000acc. to IEC 61000----

4444----2222

6 kV contact

discharge

8 kV air discharge

6 kV contact

discharge

8 kV air discharge

Floors should be wood, concrete or

ceramic tile. If floors are covered with

synthetic materials, the relative humidity

should be at least 30%.

Electrical fast Electrical fast Electrical fast Electrical fast

transients/ burst transients/ burst transients/ burst transients/ burst

acc. to IEC 61000acc. to IEC 61000acc. to IEC 61000acc. to IEC 61000----

4444----4444

2 kV for power supply

lines

1 kV for input/ output

lines

2 kV for power supply

lines

1 kV for input/ output

lines

The quality of the supply voltage should

correspond with one characteristic for a

typical commercial or hospital

environment.

Surge acc. to IEC Surge acc. to IEC Surge acc. to IEC Surge acc. to IEC

61000610006100061000----4444----5555

1 kV differential mode

2 kV common mode

1 kV differential mode

2 kV common mode

The quality of the supply voltage should

correspond with one characteristic for a

typical commercial or hospital

environment.

Voltage dips, Voltage dips, Voltage dips, Voltage dips,

shortshortshortshort----term term term term

interruptions and interruptions and interruptions and interruptions and

voltage voltage voltage voltage

variations on variations on variations on variations on

power supply power supply power supply power supply

input lines acc. input lines acc. input lines acc. input lines acc.

to 61000to 61000to 61000to 61000----4444----11111111



XE_CTT_ME_AN_140905

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4.4.4.4. UNIT DESCRIPTION & INSTALLATIONUNIT DESCRIPTION & INSTALLATIONUNIT DESCRIPTION & INSTALLATIONUNIT DESCRIPTION & INSTALLATION

The connectors have different shape to avoid installation errors.


Do not force on the connectors

4.1. Right Panel

Main switchMain switchMain switchMain switch

The user must turn on the unit (main switch to the 1 position) to supply power to the

unit, or to 0 to switch it off.


To prevent data loss, it is imperative to turn off the unit using the Start

button or the Windows 7 shut down procedure: Do not turn off the unit using

the main switch if the Windows shutdown process is not finished (turn on the

main switch when the power supply LED is orange).

Power supplyPower supplyPower supplyPower supply 2.5mm Supply Connector.

Footswitch connectorFootswitch connectorFootswitch connectorFootswitch connector It is the Audio type connector next to the handle.

BBBB----Scan probe Scan probe Scan probe Scan probe

connectorconnectorconnectorconnector B-probe (10MHz) can be plugged into this connector.

Biometry probe Biometry probe Biometry probe Biometry probe

connectorconnectorconnectorconnector

The biometry probe has a LEMO four-pin connector. It is a push-pull type connector

with a locking system.

Pachymetry probe Pachymetry probe Pachymetry probe Pachymetry probe

connectorconnectorconnectorconnector A pachymetry probe can be plugged into this rotative BNC connector

Main switch Power supply 12Vdc

Pachymetry probe

Biometry probe: TP-01b/TP-02-las

B Probe

Footswitch



XE_CTT_ME_AN_140905

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4.2. Left Panel

USB 2.0 connectorsUSB 2.0 connectorsUSB 2.0 connectorsUSB 2.0 connectors There are 2 USB connectors: used for printer or data storage key or external

keyboard

Network connector (RJNetwork connector (RJNetwork connector (RJNetwork connector (RJ----45)45)45)45) This connector is used to connect the COMPACT TOUCH to a network

2 USB Ports Network port



XE_CTT_ME_AN_140905

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4.3. Front Panel

Ref.Ref.Ref.Ref. DescriptionDescriptionDescriptionDescription

1111 Color LCD LED touchscreen

2222 Start button

3333 Power supply LED:

Orange: the COMPACT TOUCH is powered

Green: the COMPACT TOUCH is started

4444 The front knob may be used:

- to increase / decrease values

- to move the markers

- to move from one field to another one in specific screen

5555 B1 probe holder (including biometry probe holder)

6666 Biometry Test-Block: 10mm at 1550m/s

7777 Pachymetry probe holder

8888 Pachymetry Test-Block

2

8

7

1 4 3 6 5



XE_CTT_ME_AN_140905

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5.5.5.5. Installation: technical informationInstallation: technical informationInstallation: technical informationInstallation: technical information

5.1. Probe holder assembling


Before any intervention on the device, unplug the mains cord at the right side and remove all

connections.

Take the probe holder, the hexagon socket screw and its Allen key delivered with the COMPACT TOUCH.

Turn over the COMPACT TOUCH with care

Position the probe holder (main switch side). Insert the lug in the corresponding hole.

Screw on the hexagon socket screw (see below):

Probe holder for COMPACT TOUCH B or AB:

Lug location

Hexagon socket Screw location

Lug



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5.2. Patient exam area

The patient exam area is diposed as follows:

5.3. Power supply

The power supply is an external module with an automatic voltage adaptation. It includes a 2.5mm

power supply connector. For more information, refer to the:

COMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCHCOMPACT TOUCH User Manual: Chapter IIUser Manual: Chapter IIUser Manual: Chapter IIUser Manual: Chapter II---- Technical informationTechnical informationTechnical informationTechnical information

Section 2.2: Electrical requirements


Only connect the power supply provided by QUANTEL MEDICAL.



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5.4. Connections to the right and left panels

All connectors are located on the left and right panels of the unit. To avoid wrong connections, the

connectors have different shapes.


Do not force on connectors


Only connect to devices complying with the international standard: IEC 60950 for Input and Output

signals.


Do not connect USB unit (printer, mouse, keyboard) during acquisition.

Biometry Probe TP-01-b / TP-02-las

Pachymetry Probe option

B10 MHz Probe

Footswitch

USB ports

Network port

Power supply



XE_CTT_ME_AN_140905

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Be cautious when connecting devices other than the ones provided with the COMPACT TOUCH by

QUANTEL MEDICAL:

1. To comply with the IEC 60 601-1-1 Standard for Medical Systems, the configuration must respect the

following regulations:

1a) Accessories installed in the Patient Environment are considered medical devices and must

comply with the IEC 60 601-1 standard.

The Patient Environment is defined as the area in which medical diagnosis, monitoring, or treatment is

carried out, as well as the area in which intentional or unintentional contact can occur between the

patient or other persons present and parts of the system.

1b) Non-medical electrical equipment may be connected to the COMPACT TOUCH in the following

conditions:

the equipment is at least 1.5 m from the Patient Environment;

the equipment is not touched by any person in close proximity of the patient.

2. Only connect to devices complying with these international standards:

IEC 60 601-1 Medical Electrical equipment

Or IEC 60 950-1 Safety of Information Technology equipment including electrical business equipment.



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5.5. Probe connections

5.5.1. Biometry probe

The Biometry probe is equipped with a push-pull type connector with a locking system. Before inserting

the connector, rotate it slightly to find the good position.


Do not pull the cable to disconnect the probe. Pull the connector body to unlock it.

5.5.1.1. Standard probe (TP-01-b: Tono-PROBE)

The Biometry probe is uni-directional. Its small size allows it to be mounted on the Goldman tonometer in

place of the optical cone. The cable outlet along the tonometer stem does not disturb the balance of the

instrument, and the pressure regulation of the tonometer remains easily adjustable.

A hand-piece may be used to handle it more easily, either at 45 degrees or vertically

The probe hand-piece can be ordered through your local distributor or to QUANTEL MEDICAL. The

ordering code is XEAAAPAM.

The biometry probe holder

is fixed on the right of the

COMPACT TOUCH (see

figure):

FRAGILE

HANDPIECE FOR TP-01-b A-Scan PROBE



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5.5.1.2. ProBeam Probe (TP-02-las)

ProBeam is an optional probe with a laser aiming beam.

WARNING:WARNING:WARNING:WARNING:

A laser radiation is emitted from the ProBeam probe, so avoid direct eye exposure.

Sticker on the ProBeam:

Use of the probe:Use of the probe:Use of the probe:Use of the probe:

In the acquisition screen, the probe is activated by pressing on the footswitch.when the footswitch is

pressed to get an unfrozen image (with the emission echo),. The ProBeam laser aiming beam is turned

ON. The patient should then fix the red point projected on the wall (or on the ceiling) so that the patients

eye to be measured and the ProBeam are in good alignment.

5.5.2. Pachymetry Probe

The pachymetry connector is located on the right

panel. The pachymetry probe must be plugged into

this BNC connector

A specific probe holder is located on the left hand side of front

panel (see figure)

5.5.3. B-probe10 MHz

The B-probe connector is located on the right panel.

The red dot connector of the probe connector must

correspond to the red dot connector of the Compact

Touch connector.

The A probe holder is located on the right side of the

COMPACT TOUCH (see figure).

5.5.4. Footswitch

The footswitch connector is located on the right panel.

Without ProBeam (misalignment)

With ProBeam (good alignment)



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5.5.5. USB Ports

The USB ports (located on the left panel) are used to connect the following peripherals:

USB data storage device

External printer with a USB cable.

Additional USB keyboard

5.5.6. Network port

This port (located on the left panel) is used to connect the COMPACT TOUCH to a network.

5.5.7. Handle

The black handle can be used as a stand to tilt the device to a forward or backward position. Press both

sides on the rotating axis and turn the handle to the next position. A click can be heard when the handle

is locked to a specific position.

Rotating axis

User Manual III Using the COMPACT TOUCH



Tel. : +33 (0) 473 745 745 Fax : +33 (0) 473 745 700


2008

Directive 93/42/EEC

CONTENTS REV*

1. STARTING UP THE SYSTEM .............................................................................................................................................. 1

1.1. Main switch .............................................................................................................................................................. 1

1.2. Switching on the unit .............................................................................................................................................. 1

2. STARTUP SCREEN ............................................................................................................................................................... 2

3. GENERAL SETUP SCREEN .................................................................................................................................................. 3

3.1. Setup screen parameters ...................................................................................................................................... 3

3.2. Functions bar............................................................................................................................................................ 4

4. PHYSICIAN SETUP SCREEN (CREATE / MODIFY / DELETE A PHYSICIAN) .............................................................. 6

4.1. Physician setup screen parameters ................................................................................................................... 6

4.2. Functions Bar ........................................................................................................................................................... 8 4.2.1. IOL setup................................................................................................................................................ 8 4.2.2. B mode Setup (option) ........................................................................................................................ 9 4.2.3. More information (Delete Physician) ............................................................................................ 10 4.2.4. Pachymetry setup (option) .............................................................................................................. 11

a) Default selection................................................................................................................... 11 b) Mapping ................................................................................................................................. 12 c) Measurement number ......................................................................................................... 12 d) IOP ........................................................................................................................................... 13 e) Velocity ................................................................................................................................... 14 f) Bias Value .............................................................................................................................. 14 g) Bias operator ......................................................................................................................... 14 h) Freeze ...................................................................................................................................... 14 i) Buzzer ..................................................................................................................................... 14

5. PATIENT SETUP SCREEN (CREATE / MODIFY / DELETE A PATIENT) ..................................................................... 15

5.1. Keratometry .......................................................................................................................

manual user compact touch xe ctt me an 140905

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