quantel medical compact touch manual

Chapters:

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

USER MANUAL

Quantel Medical 11, rue du bois joli - CS 40015

63808 Cournon d’Auvergne 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

June 24, 2013

http://www.quantel-medical.com/

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 d’Auvergne 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

© 2013 Quantel Medical. All rights reserved. Compact Touch User Manual (Soft V 3.01) International version (Ref: XE_CTT_ME_AN) June 24, 2013



User Manual: Introduction

June 24, 2013 Quantel Medical 11, rue du bois joli - CS 40015


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


2008

Directive 93/42/EEC


CONTENTS

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

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

3. USER MANUAL TERMS AND SAFETY SYMBOLS .................................... 2

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

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

COMPACT TOUCH User Manual: Introduction

24-06-2013 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-a Regulatory & safety information_Europe I-b Regulatory & safety information_USA II Technical information III Using the COMPACT TOUCH IV Maintenance V Appendix: IOL formulae


24-06-2013 2

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

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 10°C (50°F): 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


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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-a _ Regulatory and safety information SPECIFIC TO EUROPE



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


2008

Directive 93/42/EEC


CONTENTS

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

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

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

2.2. Precautions to take concerning wastes and elimination of device and accessories: ....................................................................................................... 3

2.3. How to prevent a transfer of infection ........................................................ 4 2.3.1. Procedure for decontamination, pre-disinfection and disinfection of

probes (specific to Europe) ........................................................... 5 2.3.2. Preventive method: Finger cots for B probes ................................ 9

COMPACT TOUCH User Manual: I-a_Regulatory and safety information SPECIFIC TO EUROPE

24-06-2013 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. • Do not use flammable anesthetics product. • Do not use in oxygen rich atmosphere. • Some persons are extremely allergic to isopropyl alcohol. • To avoid risk of electric shock, this equipment must only be connected to

supply mains with protective earth. • Connect only power supply module provided by Quantel Medical. • While using the unit, mains plug must be easily accessible. • Disconnect AC power before cleaning the case. • AC power should be disconnected every time after turning the system OFF • 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

• The Compact Touch has to be disconnected from the telecom, IT network and/or USB accessories during examination.


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• 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.

• 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 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. • Probes must be disinfected prior to first use.

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.

• The probes should never be autoclaved or subjected to excessive heat. • 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 unit’s 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).


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2.2. Precautions to take concerning wastes and elimination of device and accessories:

This product complies with the WEEE Directive (2002/96/EC) 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.

mailto:[email protected]



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2.3. How to prevent a transfer of infection WARNINGS

• The probe must be cleaned between two patients to prevent patient-to-patient transfer of infection. The probe may be cleaned using Cidex liquid disinfectant, usually found in hospitals. Follow the instructions on the label.

• Probes must be disinfected prior to first use.

CAUTIONS • The B-probe must not be totally immersed, only the tip of the probe should be

placed in liquid for disinfection purposes. Maximum immersion depth for B-probe is 5 cm. The A-scan probe can be immersed.

• Do not immerse the connector. • Do not autoclave the probe or the cable • After cleaning; rinse the end of the probe thoroughly with clean water to

remove all traces of liquid used. • Follow the instructions on the label of commercial disinfectants. • The surfaces should then be dried with a lint-free cloth.


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2.3.1. Procedure for decontamination, pre-disinfection and disinfection of probes (specific to Europe)

The standard protocol (A/) must be used to ensure satisfactory pre-disinfection and disinfection of the probe after use. The risky patient (B/) protocol must be used to ensure satisfactory pre-disinfection - inactivation and disinfection of the probe after use on a patient when there is a risk of transmission of Creutzfeld-Jacob disease.

WARNINGS • The ultrasound unit must be imperatively turned off before disconnecting the

probes. Avoid splashing liquids onto the probe connectors. • Respect the preparation and the disinfection time preconized by the

manufacturer.

What’s needed? Operator’s clothing

Single use overall. Disposable gloves, sterile for disinfection. Glasses and anti-projection mask.

Material

Soft silk brush (surgical nail brush). 3 x 500ml stainless (or plastic), autoclavable soaking trays. 4l and 5l cans. Single use hand cloths (e. g. Kimwipes®). Demineralized or distilled water. Concentrated bleach 9,6% a.c. (~36°chl)

Products Pre-disinfectant: Sodium hypochlorite at 0,5% a.c (~1,5°chl). Disinfectant: Sodium hypochlorite at 2% a.c. (~6°chl).

NOTE Measure units: % a.c. = active chlorine percent

°chl = Gay-Lussac chlorometric degree.


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Agent preparation Disinfectant 2% a.c. sodium hypochlorite preparation

Pour 1l of warm water (20 to 30°C) from the tap into the 5l can. Pour 4 packs (4x250ml=1l) of concentrated bleach 9,6%ac (~36°chl) into the 5l recipient Fill up the can (3l more) with warm tap water and stir. (The 2% sodium hypochlorite solution can be stored 6 months in the can in a room unexposed to day light at 20°C.)

Pre-disinfectant: 0,5% a.c. sodium hypochlorite Pour 1l of warm water (20 to 30°C) from the tap in the 4l can. Pour 1l of 2% sodium hypochlorite solution prepared according to the above procedure. Fill up the can (2l more) with warm tap water and stir. (The 0, 5% sodium hypochlorite solution can be stored 6 months in the can in a room unexposed to day light at 20°C.)

Soaking trays contents renewing

The contents of the soaking trays should be replaced every day.

WARNINGS

• The contents of the soaking trays should be replaced every day. For frequent use, the contents of the soaking trays should be replaced at the beginning of the morning and at the beginning of the afternoon.

• Wait at least 10 minutes after the last disinfection before emptying out the content of the soaking trays.


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A/ Standard protocol Steps “A” type of probe “B” type of probe

Decontamination – pre-disinfection

Immerse the probe and its cable (except for the connector) in a 0,5% sodium hypochlorite solution for 15 min.

Immerse the probe on the first 5cm in a 0,5% sodium hypochlorite solution for 15 min.

.

Clean the probe extremity in the 0,5% sodium hypochlorite solution for 1 min using the brush. Clean the rest of the probe body that was not soaked using a wipe dampened with solution.

Rinsing

Rinse the probe and clean the cable with a cloth

dampened with demineralized or distilled water. Do not wet the connectors.

Disinfection

Immerse the probe and its cable (except the connector) in a 2% sodium hypochlorite solution for 15 min.

Immerse the probe on the first 5cm in a 2% sodium hypochlorite solution for 15 min. Clean the rest of the probe body that was not soaked using a wipe dampened with solution.

Rinsing

Rinse the probe and clean the cable with a cloth dampened with demineralized or distilled water. Do not wet the connectors.

Drying

Dry with a sterile non-woven swab or single use cloth if the rinsing water was sterile.

The probe is ready for use.


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B/ Risky patient protocol Steps “A” type of probe “B” type of probe

Decontamination – pre-disinfection

Immerse the probe and its cable (except for the connector) in a 0,5% sodium hypochlorite solution for 15 min.

Immerse the probe on the first 5cm in a 0,5% sodium hypochlorite solution for 15 min

.

Clean the probe extremity in the 0, 5% sodium hypochlorite solution for 1 min using the brush. Clean the rest of the probe body that was not soaked using a wipe dampened with solution.

Rinsing

Rinse the probe and clean the cable with a cloth

dampened with demineralized or distilled water. Do not wet the connectors.

Inactivation

Immerse the probe and its cable (except the connector) in a 2% sodium hypochlorite solution for 60 min at 20°C.

Immerse the probe on the first 5cm in a 2% sodium hypochlorite solution for 60 min at 20°C. Clean the rest of the probe body that was not soaked using a wipe dampened with solution.

Rinsing


Disinfection

Immerse the probe and its cable (except for the connector) in a 2% sodium hypochlorite solution for 15 min.

Immerse the probe on the first 5cm in a 2% sodium hypochlorite solution for 15 min. Clean the rest of the probe body that was not soaked using a wipe dampened with solution

Rinsing


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WARNING

• Wait at least 10 minutes after the last disinfection before emptying out the content of the soaking trays.

• Respect the preparation and the disinfection time preconized by the manufacturer.

2.3.2. Preventive method: Finger cots for B probes Finger cots are a simple way of preventing probe contamination:


Drying

Dry with a sterile non-woven swab or single use cloth if the rinsing water was sterile.

The probe is ready for use.


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In case of a low potential risk, the finger cot use makes it unnecessary to apply the standard protocol after each patient; however a daily application of this standard protocol must be maintained. In case of a high potential risk, the finger cot use is only a supplement to the “protocol for high risk patients” to be applied.

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)

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.


24-06-2013 11

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

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

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

User Manual: I-b _ Regulatory and safety information SPECIFIC TO USA



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


2008

Directive 93/42/EEC


CONTENTS

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

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

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

2.2. Precautions to take concerning wastes and elimination of device and accessories: ....................................................................................................... 3

2.3. How to prevent a transfer of infection ........................................................ 4 2.3.1. Disinfection procedure (specific to US) ......................................... 5 2.3.2. Preventive method: Finger cots for B probes ................................ 5

COMPACT TOUCH User Manual: I-b_Regulatory and safety information SPECIFIC TO USA

24-06-2013 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, even at FDA pre-enactment levels, 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

• USA Federal Law requires that this device be sold only by on the prescription of a physician.

• This device is not intended for foetal use. • Do not use flammable anesthetics product. • Do not use in oxygen rich atmosphere. • Some persons are extremely allergic to isopropyl alcohol. • To avoid risk of electric shock, this equipment must only be connected to

supply mains with protective earth. • Connect only power supply module provided by Quantel Medical. • While using the unit, mains plug must be easily accessible. • Disconnect AC power before cleaning the case. • AC power should be disconnected every time after turning the system OFF • 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

COMPACT TOUCH User Manual: I-a_Regulatory and safety information SPECIFIC TO USA

24-06-2013 2

• 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.

• 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 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. • Probes must be disinfected prior to first use.

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.

• The probes should never be autoclaved or subjected to excessive heat. • 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 unit’s 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).


24-06-2013 3

2.2. Precautions to take concerning wastes and elimination of device and accessories:

This product complies with the WEEE Directive (2002/96/EC) 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.




24-06-2013 4

2.3. How to prevent a transfer of infection

WARNING • The probe must be cleaned between two patients to prevent patient-to-patient

transfer of infection. The probe may be cleaned using Cidex liquid disinfectant, usually found in hospitals. Follow the instructions on the label. Other FDA-cleared disinfectants may also be used.

• Probes must be disinfected prior to first use.

CAUTIONS • The B-probe must not be totally immersed, only the tip of the probe should be

placed in liquid for disinfection purposes. Maximum immersion depth for B-probe is 5 cm. The A-scan probe can be immersed.

• Do not immerse the connector. • Do not autoclave the probe or the cable • After cleaning; rinse the end of the probe thoroughly with clean water to

remove all traces of liquid used. • Follow the instructions on the label of commercial disinfectants. • The surfaces should then be dried with a lint-free cloth.


24-06-2013 5

2.3.1. Disinfection procedure (specific to US) 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 probe’s 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.

2.3.2. Preventive method: Finger cots for B probes Finger cots are a simple way of preventing probe contamination: In case of a low potential risk, the finger cot use makes it unnecessary to apply the standard protocol after each patient; however a daily application of this standard protocol must be maintained. In case of a high potential risk, the finger cot use is only a supplement to the “protocol for high risk patients” to be applied.

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


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Equipment:

Preventive protection: • LATEX membrane • Nitrile membrane (prevents allergy to LATEX)

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’s body.


24-06-2013 7

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

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

User Manual: II – Technical information



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


2008

Directive 93/42/EEC


CONTENTS

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 ........................................................................... 5 2.6.1. Biometry Probe (option) ................................................................ 5 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 ........................................................... 6 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-probe–10 MHz ......................................................................... 25 5.5.4. Footswitch ................................................................................... 26 5.5.5. USB Ports ................................................................................... 26 5.5.6. Network port ................................................................................ 26 5.5.7. Handle ......................................................................................... 26

COMPACT TOUCH User Manual: II – Technical information

24-06-2013 1

1. LABELS 1.1. On the back panel

Identification label information:

Ref. Labels & Description

Identification label

Protection against electrical shocks: the applied parts are

classified as “BF Type". IEC 60417-5333

IEC protection class: "Class II” IEC 60417-5172

Refer to the instruction manual/ booklet ISO 7010-M002

For indoor use only. IEC 60417-5957

Electrical/electronic equipment in accordance with the Directive 2002/96/EC (WEEE) Do not dispose with domestic household wastes. EN 50419

General warning sign ISO 7010-W001 General

This label specifies the manufacturing date indication. ISO 7000-2497

Federal US law label :


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1.2. On the right panel

Réf. Labels & Description

Power supply specifications

Probes & footswitch connectors label:

Options : Pachymetry probe

A probe

B probe

1.3. On the left panel

Réf. Labels & Description

Standby icon

USB / NETWORK connector label

2 USB connectors (type 2.0)

Footswitch


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1.4. Footswitch

Réf. Label

IP44 (According to IEC 60529):

- Protection against the penetration of foreign solid bodies of diameter Ø ≥ 1 mm. - Protection against splashing water.

Electrical/electronic equipment in accordance with the Directive 2012 /19 / UE (WEEE) Do not dispose with domestic household wastes. EN 50419

2. TECHNICAL SPECIFICATIONS 2.1. Classification

The system is intended for continuous operation and has the following classification: Electric security class EN 60 601-1 Standard Protective class II Type BF (protection against electrical shocks)

2.2. Electrical requirements

CAUTION Only connect the power supply module provided by Quantel Medical.

Power supply External module with automatic voltage adaptation: no selection is needed

Input voltage 100-240 Vac Single phase without earth

Frequency 47-63 Hz Mains consumption 70 VA

Compact Touch consumption 12 Vcc 5A Class II

Reference TR60M12 Trade Mark Cincon Electronics


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2.3. Compliance STANDARD SUBJECT

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

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

IEC 60 601-1-2 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance – Amendment electromagnetic compatibility – requirements and testing

IEC 60 601-1-6 Medical electrical equipment-Part 1-6: General requirements for basic safety and essential performance – Amendment: usability

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

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

ISO 14 971 Medical devices – Application of risk management to medical devices (ISO/DIS 14971)

93/42/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 < T° < 35 °C (50°F < T° < 95°F)

The relative humidity must not exceed 95% without condensation The Device storage and transportation temperature must be within the following range:

-20 °C < T° < 70 °C (- 4°F < T° < 158°F)

Maximum operating altitude: 2000m (about 7000 ft)


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2.6. Echograph specifications

2.6.1. Biometry Probe (option)

Probe Reference TP-01-b (Tono-Probe) or TP-02-las (ProBeam)

Frequency 11 MHz Focal Length 20 to 25 mm Emission running mode Pulsed Emission Repetition Rate 67 Hz

Active diameter 5 mm Active surface 20 mm2 Axial resolution 0.15 mm (at - 6dB)

2.6.2. 10 MHZ B-SCAN Probe (option)

Probe Reference B1 Sector angle 50° Frequency 10 MHz Emission-running mode Pulsed Focal length 24mm to 26mm Active diameter 7.5mm Active surface 44mm² Axial resolution 0.2mm (at -6dB) Lateral resolution 0.6mm (at -6dB)

2.6.3. Pachymetry Probe (option)

Probe Reference P1 Type A Ceramic Frequency 20 MHz Material PZT ceramic Emission Repetition Rate 5882 Hz

2.6.4. Acquisition echograms

Points in X axis 1536 Points in Y axis 256 Electronic resolution 0.03mm at 1550m/s

2.6.5. Measurements accuracy The accuracy is achieved by the electronic resolution: ± 0.03 mm

CAUTION 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


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2.6.6. Accuracy on IOL calculation Display resolution on IOL power: ± 0.1 Diopter.

NOTE 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.

2.6.7. Physiological limits of measurements

Physiological limits of measurements (auto) Minimum (mm)

Maximum (mm)

Phakic

Anterior chamber at: 1532 m/s 1.5 7

Lens thickness at 1641 m/s 2.5 7

Total length = AC+L+V 14 45

Pseudo-phakic

Anterior chamber at: 1532 m/s 1.5 7

Lens thickness at 1641 m/s 0.5 7

Total length = AC+L+V 14 45

Aphakic Total length at 1532 m/s 14 45

NOTE 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.

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

Parameters Allowable range

Minimum Maximum

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

Dense cataract velocity 500 m/s 5000 m/s

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

Keratometry in millimeters 5 mm 13 mm

Keratometry in diopter 25.0 D 68.0 D

Total length in IOL calculation screen 15 mm 40 mm

Anterior chamber in IOL calculation screen 0 mm 9.9 mm

Post-operative ametropia -20.0 D +20.0 D

SRK A constant 113.00 120.59

Holladay surgeon factor calculated from A -1.61 +2.69

Hoffer-Q ACD 2.05 6.48

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

Constant for Haigis formula: a0 -10 +10

Constant for Haigis formula: a1, a2 -1 +1

Haigis constants: combined limits for a (1.16 to 7mm) ACD 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 frame Polyurethane plastic complying with the UL 94 V0 standard

Lower frame Painted steel sheet LCD LED front panel Painted steel sheet

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

A-Scan Body material Delrin 100 Face material Insulcast I-124 Epoxy Manufacturer Permagile

Pachymetry Body material Delrin 100 Face material REXOLITE 1422 Manufacturer Blatek

B-Scan 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.

WARNING 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:

It = Iwexp(-0.069fz)

Where: • It = is the estimated in situ intensity • Iw is the measured intensity in water at the focus of the transducer • f is the ultrasonic frequency in megahertz • z 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.


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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 user’s 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: 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:

ISPTA.3

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

ISPPA.3 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.

Ml 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. PR.3 The derated peak rarefactional pressure (megapascals) associated with the

transmit pattern giving rise to the value reported under MI. Wo 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.

fc 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.

zSP The axial distance at which the reported parameter is measured (centimeters). x-6, y-6 Are respectively the in-plane (azimuthal) and out-of-plane (elevational) -6dB

dimensions in the x-y plane where zsp is found (centimeters). PD Pulse duration (microseconds) associated with the transmit pattern giving rise to

the reported value of the respective parameter. PRF Pulse repetition frequency (Hz) associated with the transmit pattern giving rise to

the reported value of the respective parameter. EBD Entrance beam dimensions for the azimuthal and elevational planes

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

(centimeters).


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2.8.2.1. A-Scan probe (option)

Probe reference TP-01-b / TP-02-las (ProBeam) Type A-scan Material PZT ceramic Frequency 11 MHz Ultrasonic intensities in tissue at measured transducer focus (22mm from probe tip). ISPTA.3 0.140 mW/cm2 ISPPA.3 11.611 W/cm2 Mechanical index 0.16 Ultrasonic power 0.013 mW Transducer model TP-01-b / TP-02-las (ProBeam) Operating Mode A-Scan Application Ophthalmic biometer

Acoustic output MI ISPTA.3 (mW/ cm2)

ISPPA.3 (W/ cm2)

Maximum Value 0.16 0.140 11.611

Ass

ocia

ted

Aco

ustic

Pa

ram

eter

s

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 (µm) 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 reference B1 Type B mode Material Composite material Frequency 10 MHz Pulse repetition frequency

4655 Hz

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

ISPTA.3 0.22 mW/cm2 ISPPA.3 24.3 W/cm2 Mechanical index 0.196 Ultrasonic power 0.208 mW Transducer model 10 MHz Ophthalmic Probe Operating Mode B-mode Application Ophthalmic


ISPPA.3 (W/ cm2)

Maximum Value 0.196 0.22 24.3

Ass

ocia

ted

Aco

ustic

Pa

ram

eter

s

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 (µs) 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 reference P1 Type A Tip diameter 1.2mm Active tip diameter 1.5mm Focal point 0.5mm from the tip Material PZT ceramic Ceramic frequency 20MHz Angle 45 degrees

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

ISPTA.3 0.097 mW/cm2 ISPPA.3 0.655 W/cm2 Mechanical Index 0.04 Ultrasonic power 0.0009 mW Transducer model Pachymeter Operating mode A-Scan Application Ophthalmic Pachymeter


ISPPA.3 (W/ cm2)

Maximum Value 0.04 0.097 0.655

Ass

ocia

ted

Aco

ustic

Pa

ram

eter

s

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 (µs) 0.05 0.05 PRF (Hz) 2800 2800

EBD Az (cm) 0.12 E1 (cm) 0.12

Accuracy 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.


24-06-2013 13

The operator should minimize errors by keeping the probe perpendicular to the cornea and applying as little pressure as possible. 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.

NOTE 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. COMPACT TOUCH: EMC DATA AND GUIDELINES

WARNING Medical electrical equipment needs special precautions regarding EMC. The following EMC guidelines must be observed during installation and commissioning of the Compact Touch.

WARNING

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

Guidance and manufacturer’s declaration – electromagnetic emissions

The Compact Touch is intended for use in the electromagnetic environment specified below. The operator of the Compact Touch has to make sure that it is used in such an environment.

Emission test Compliance Electromagnetic environment - Guidance

RF emission acc. to EN 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 EN 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. to IEC 61000-3-2

Class A

Voltage fluctuations / Flicker emissions acc. to IEC 61000-3-3

Complies


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Guidance and manufacturer declaration – electromagnetic immunity

The Compact Touch is intended for use in the electromagnetic environment specified below. The operator of the Compact Touch has to ensure that it is used in such an environment.

Immunity Test CEI 60601 test level Compliance level

Electromagnetic environment - Guidance

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. Recommended separation distance:

Conducted RF disturbances according to IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

10 V

Pd 35,0=

Radiated RF disturbances according to IEC 61000-4-3

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 higher frequency range applies. NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a 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 accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device Compact Touch is used exceeds the applicable RF compliance level above, additional measures may be necessary, such as reorientation or relocating the Compact Touch. In case unusual performance is witnessed, additional measures may be required such as change of orientation or location of the Compact Touch. b Field strength should be less than 3 V/m in the range between 150 kHz and 80 MHz


24-06-2013 15

Recommended separation distances between portable and mobile RF communications

equipment and the Compact Touch

The Compact Touch is intended for use in an electromagnetic environment in which the radiated RF disturbances are controlled. The Compact Touch user can help prevent electromagnetic interference by maintaining a minimal distance between portable and mobile RF communications equipment (transmitters) and the Compact Touch as recommended below, according to the maximum output power of the communications equipment.

Maximum transmitter power output (W)

Separation distance according to the transmitter’s frequency (m) 150 kHz to 80 MHz

Pd 35,0=

80 MHz to 800 MHz

Pd 35,0=

800 MHz to 2,5GHz

Pd 7,0=

0,01 0,035 0,035 0,07 0,1 0,11 0,11 0,22 1 0,35 0,35 0,70

10 1,1 1,1 2,2 100 3,5 3,5 7,0

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum emission output power of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 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 affected by absorption and reflection from structures, objects and people.


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Guidance and manufacturer declaration – electromagnetic immunity The Compact Touch is intended for use in the electromagnetic environment specified below. The operator of the Compact Touch has to ensure that it is used in such an environment. Immunity Test CEI 60601 test level Compliance level Electromagnetic environment -

Guidance Electrostatic discharge (ESD) acc. to IEC 61000-4-2

± 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 transients/ burst acc. to IEC 61000-4-4

± 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 61000-4-5

± 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, short-term interruptions and voltage variations on power supply input lines acc. to 61000-4-11

<5% during 0,5 period 40% during 5 periods 70% during 25 periods <5% during 5 s

<5% during 0,5 period 40% during 5 periods 70% during 25 periods <5% during 5 s

The quality of the supply voltage should correspond to one characteristic for a typical commercial or hospital environment. If the user of the Compact Touch requires a continuous function of the appliance also during interruptions of the power supply, it is recommended to supply the Compact Touch out of an uninterruptible power supply or a battery

Power frequency (50/60Hz) magnetic fields acc. to IEC 61000-4-8

3 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic for commercial or hospital environments


24-06-2013 17

4. UNIT DESCRIPTION & INSTALLATION The connectors have different shape to avoid installation errors.

WARNING

Do not force on the connectors

4.1. Right Panel

Main 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. CAUTION:

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 supply 2.5mm Supply Connector. Footswitch connector It is the Audio type connector next to the handle.

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

Biometry probe connector

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

Pachymetry probe connector

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


24-06-2013 18

4.2. Left Panel

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

Network connector (RJ-45)

This connector is used to connect the Compact Touch to a network

2 USB Ports Network port


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4.3. Front Panel

Ref. Description 1 Color LCD LED touchscreen 2 Start button 3 Power supply LED:

Orange: the Compact Touch is powered Green: the Compact Touch is started

4 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

5 B1 probe holder (including biometry probe holder) 6 Biometry Test-Block: 10mm at 1550m/s 7 Pachymetry probe holder 8 Pachymetry Test-Block

2

8

7

1 4 3 6 5


24-06-2013 20

5. Installation: technical information 5.1. Probe holder assembling

CAUTION

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


24-06-2013 21

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 Touch User Manual: Chapter II- Technical information Section 2.2: Electrical requirements

CAUTION:

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.

WARNING

Do not force on connectors

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

CAUTION: 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


24-06-2013 23

CAUTION:

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.

CAUTION: 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


24-06-2013 25

5.5.1.2. ProBeam Probe (TP-02-las)

ProBeam is an optional probe with a laser aiming beam. WARNING:

A laser radiation is emitted from the ProBeam probe, so avoid direct eye exposure. Sticker on the ProBeam: 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 patient’s 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-probe–10 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).

Without ProBeam (misalignment)

With ProBeam (good alignment)


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5.5.4. Footswitch The footswitch connector is located on the right panel.

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

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 .............................................................................. 13 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 ....................................................................................................................... 16

5.2. Keratometry for post-refractive surgery cases .................................................................. 16

5.3. Exam history ...................................................................................................................... 17

5.4. Implanted IOL .................................................................................................................... 18

5.5. More information ................................................................................................................ 18

6. ACQUISITION SCREENS (USING THE OPTIONS) ................................................................... 19

6.1. Biometry ............................................................................................................................. 19 6.1.1. A-Probe preparation ........................................................................................... 19 6.1.2. Acquisition .......................................................................................................... 20

6.1.2.1. Functions description ............................................................................... 20 6.1.2.2. Automatic acquisition ............................................................................... 22 6.1.2.3. Conditions for automatic acquisition ........................................................ 23 6.1.2.4. Manual acquisition ................................................................................... 23 6.1.2.5. Result table / Stat-2 calculation ............................................................... 24 6.1.2.6. IOL calculation ......................................................................................... 25

a) Standard IOL calculation .................................................................... 26 A. IOLs selection ..................................................................................... 26 B. Formulae selection ............................................................................. 26 C. Post-operative ametropia .................................................................... 27 D. Increment ............................................................................................ 27 b) Post Refractive IOL calculation........................................................... 27 c) Saving the IOLs results ....................................................................... 27 d) Printing the IOLs results ..................................................................... 28

6.1.3. Biometry guided by B-Mode (Compact Touch B and AB) ................................. 28 6.1.4. Footswitch functions for A mode (review) .......................................................... 30

6.2. B-Scan ............................................................................................................................... 31 6.2.1. Functions description ......................................................................................... 31 6.2.2. Add to report / Remove image from report ........................................................ 34 6.2.3. Mouse right click functions ................................................................................. 34 6.2.4. Footswitch functions for B Mode (as well as for Bio Mode guided with B10 probe) ........................................................................................................................... 35 6.2.5. Cineloop sequence ............................................................................................ 35 6.2.6. Post processing .................................................................................................. 36

6.2.6.1. Caliper (To measure a distance) ............................................................. 37 6.2.6.2. Marker (To indicate a particular point on the image and give comments)37 6.2.6.3. Area (To draw a field and calculate the surface area) ............................. 38

6.3. Pachymetry ........................................................................................................................ 39 6.3.1. Acquisition mode: Center only ........................................................................... 40 6.3.2. Acquisition mode: Automatic .............................................................................. 41 6.3.3. Acquisition mode: Continuous ........................................................................... 41 6.3.4. Acquisition mode: Scanning ............................................................................... 42

7. PRINTING .................................................................................................................................... 43

7.1. Printing from the biometry mode acquisition screen ......................................................... 44

7.2. Printing from the IOL calculation screen: .......................................................................... 45

7.3. Printing from the B mode examination screen .................................................................. 46

7.4. Printing from the Pachymetry mode examination screen .................................................. 47

7.5. Printing from the exam history ........................................................................................... 48 7.6. Preview report.................................................................................................................... 48

7.7. Export in Excel, PDF or Word format ................................................................................ 48

COMPACT TOUCH User Manual: III – Using the Compact Touch Unit

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1. STARTING UP THE SYSTEM

1.1. Main switch The main switch located on the right side of the Compact touch unit allows the user to supply power to the system when it is turned on (“I” position): the orange power supply LED on the front panel lights up.

1.2. Switching on the unit Press on the green button located on the left side of the unit to boot up the system and access the Compact Touch Start Up screen: the green power supply LED on the front panel lights up.


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2. STARTUP SCREEN

The following icons appear permanently in the lower part of all screens. They give access to the below listed functions and are activated either by using a stylus, a mouse click or at a finger press.

Icons Selecting the icon allows the user to:

Return to the previous screen (or startup screen).

Return to the Startup screen.

Open the Patient screen: Section 5 : Patient setup screen (Create / Modify / Delete a patient)

Open the Biometry screen: Section 6-1 : Biometry.

Open the IOL calculation screen. Section 6-1-2-5 : IOL calculation

Open the B mode screen. This button is present only if the option has been validated. Section 6-2 : B-scan

Open the Pachymetry screens. This button is present only if the option has been validated. Section 6-3 : Pachymetry

Print different documents according to the context. Section 7 : Printing

Save the modifications or the recordings. When this icon is activated: a beep is emitted while the bottom bar highlights up in green.

According to the context, an alphanumeric or a numeric keyboard is displayed. It is possible to move it by using the “hand” button: Or select the keyboard red button to close it:


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3. GENERAL SETUP SCREEN When pressing the button: , the following screen is displayed:

3.1. Setup screen parameters

Position of marker # 1 in Contact (mm): +0.00 mm

These fields allow the user to test/adjust calibrations for two types of biometry probes (there are two available positions of marker # 1 in contact):

• For the standard A-probe (TP01-b probe) • For the ProBeam (A-probe with laser aiming beam) (TP02-las probe)

It is possible to adjust the marker # 1 in Contact value by steps of 0.01 mm (“+” or “-”, according to the rounded calculation result at 1550m/s).

To modify the values, select one of the corresponding fields: the following function keys will be displayed at the bottom of the screen:

Selecting one of those icons allows the user to access the calibration screen. For more information about calibrating the unit, please refer to the: Compact Touch User Manual: Chapter IV - Maintenance.

Selecting the checkbox allows the user to activate/ inactivate the use of the probe. Only the activated probes will appear in the acquisition screen.

Language and keyboard selection By clicking in the corresponding areas, a drop down menu gives access to: - The language selection English / Français / Español / Deutsch / Russian - The keyboard type selection:


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EMR (Electronic Medical Record): The EMR folder location may be changed if needed. Select the “Export Folder of EMR Files” field: an “EMR Directory” button appears at the bottom of the screen. Select it to open a “Browse For Folder” window and choose the location for the EMR folder to be saved. NOTE: It is recommended to select the “EMR directory” on the unit’s hard disk because the “EMR” data are used by the COMPACT TOUCH to visualize the reports. If the “EMR directory” is saved on an external key or network (for example), make sure the external key or the network is still connected to the unit to visualize the reports and saved exams. Also, the backup function (Save All Data) may not work in case the EMR file path has been changed, moreover if it is not located under the Compact touch hard drive.

CAUTION: Never modify the EMR path in case exams have already been performed, otherwise those will not be accessible anymore from the “Exam History” screen.

Screen displayed by default on unit startup: It is possible to select the screen displayed by default when starting the COMPACT TOUCH. It can be chosen from the following list of screens (depending of the available options):

• Physician • Patient • Biometry

• IOL • B Exam • Pachymetry

Activate USB video printer: When activated, this option allows printing with a USB video printer from the exam page. To do so, press on the “Print” icon: the impression will be automatically carried out on the A6 printer

Operator list: The user can enter the Last Name and first Name of all operators that may use the unit.

3.2. Functions bar

Default IOL Setup: Selecting the following icon allows the user to modify an IOL name or value:

The “Default IOL setup when creating a New Physician” screen also allows the user to delete or create a new IOL. When a new user is created, the IOLs parameters chosen in this screen are displayed by default. However, in his own configuration screen, the user will also be able to personalize (choose and/or modify) the IOLs names and values.


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CAUTION: • A, SF and ACD are linked together. Modifying one of them will impact the value

of the others. • The Haigis default values a0 is also calculated from the A constant. • All the parameters can be modified within the limits described in:

Compact Touch User Manual: Chapter II – Technical information Section 2-6-8 – “Data entry limits”

• The Haigis constants (a0, a1, a2) also have to be modified within the combined limits described in this same chapter.

For more details, please refer to: Compact Touch User Manual: Chapter V – Appendix: IOL formulae

CAUTION: It is recommended to create a backup of this IOL table prior to any modification or unit servicing. The default values of these constants are:

IOL Type A SF Acd Acd Acd a0 a1 a2 (H offerQ) (Binkhorst) (Shammas)

1 Post 115.00 -0.475 3.215 3.215 2.703 -0.597 0.400 0.100 2 Post 115.30 -0.306 3.390 3.390 2.878 -0.410 0.400 0.100 3 Post 115.80 -0.022 3.682 3.682 3.169 -0.097 0.400 0.100 4 Post 116.60 0.431 4.148 4.148 3.636 0.403 0.400 0.100 5 Post 117.90 1.167 4.907 4.907 4.395 1.215 0.400 0.100 6 Post 118.50 1.507 5.257 5.257 4.745 1.589 0.400 0.100 7 Post 118.70 1.620 5.374 5.374 4.861 1.714 0.400 0.100 8 Post 119.08 1.835 5.596 5.596 5.083 1.952 0.400 0.100

Save all data:

This function allows the user to save all Compact Touch data on the unit hard disk or on an external memory system. NOTE: For more details about archiving the Compact touch database, please refer to: Compact Touch User Manual: Chapter IV - Maintenance.

CAUTION: It is recommended to perform a database backup on a regular basis as well as before any modification or unit servicing.

Windows access:

Selecting this icon allows the user to use Windows functionalities.


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

In the startup screen, press the NEW PHYSICIAN function (to create a physician) or the PHYSICIAN SETUP function (to modify the selected physician):

or

The following screen is displayed:

4.1. Physician setup screen parameters Last Name / First Name fields:

The “Last name” and “First name” fields are alphanumeric. A keyboard automatically appears when the user presses on one of these fields. NOTE: Most fields in the lower part of the screen have pre-defined values. Use the knob to scroll through the pre-defined values in each field or to change the values.

Display modes: A scans can be displayed with 2 different markers positioning modes: D1 & D2.

“D1” (adjustable dynamic): The markers are positioned at the top of the echoes pics. Displayed Dynamic : 35dB

“D2” (fixed and low dynamic at 20dB): Markers are positioned on the rising edge of the echoes at the threshold level Displayed Dynamic : 20dB (more contrast)


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NOTE: It is not advised to use D2 mode when using the “Contact” technique.

Other parameters:

Dyn D1 25 to 90dB. Dynamic displayed by default in the Biometry scan image with D1 mode selected (Default value: 35dB)

TGC The “Time Gain Control” is used to reduce the Gain at the beginning of the echoes and progressively recover the general Gain at 18 mm depth. The maximum value is 30 dB. (Default value: 10dB)

Default Gain From 20 to 110dB. Default gain which will be used when starting the acquisition: 80dB. Default gain factory setting: 80 dB;

Mode Manual, Auto, Auto + Save Technique - Contact (Acquisition Technique in contact with cornea)

- Immersion (Using a water bath interface with a scleral shell) Velocities Anterior chamber (AC): 1532 m/s by default

Lens (L): 1641 m/s by default Dense/Long: 1641 m/s by default Vitreous (V): 1532 m/s by default Different implant materials for lens and vitreous may be entered.

Lens Materials table

This table may be used to enter new lens materials / or modify names with an associated speed of propagation (m/s): By default: PMMA: 2718m/s Acrylic: 1946m/s Silicon: 1050m/s

Vitreous materials table

Vitreous materials table this table is used to enter silicone oil propagation speeds in case of silicone filled eyes. Factory default parameters are: Silicone 1000: 980 m/s Silicone 5000: 1050 m/s These parameters must be modified by the user according to the type of silicone oil and its viscosity.


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4.2. Functions Bar

4.2.1. IOL setup

Select :

The Compact Touch can calculate up to four implants at once. The user can use this IOL setup screen to choose four IOLs and formulae:

Selecting: allows the user to modify the name, values of the IOLs constants and personalize the IOL file. This “Physician IOL File screen” also allows the user to delete or create an IOL.

CAUTION: • A, SF and ACD are linked together. Modifying one of them will impact the value

of the others. • The Haigis default values a0 is also calculated from the A constant. • All the parameters can be modified within the limits described in:

Compact Touch User Manual: Chapter II – Technical information Section 2-6-8 – “Data entry limits”

• The Haigis constants (a0, a1, a2) also have to be modified within the combined limits described in this same chapter.

For more details, please refer to: Compact Touch User Manual: Chapter V – Appendix: IOL formulae

CAUTION: It is recommended to create a backup of this IOL table prior to any modification or unit servicing.


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4.2.2. B mode Setup (option)

This feature requires an activation keycode. Please contact QUANTEL MEDICAL or your local distributor for details on how to order this package and get activation keycode.

Select the B Setup button:

The default parameters for the use of the B probe may be entered in this page:

• Gray level correction (black and white levels). • Acquisition parameters by default (Gain, Dyn, TGC, Default Zoom, Default size

of the scan Screen, Default cineloop format for saving).


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4.2.3. More information (Delete Physician) Select the button:

NOTE: All the entered information will be printed in the reports.

By pressing on the following function, the physician data will be deleted for good:


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4.2.4. Pachymetry setup (option) This feature requires an activation keycode. Please contact QUANTEL MEDICAL or your local distributor for details on how to order this option and get an activation keycode.

Select:

NOTE: For default value resetting, press the following button:

a) Default selection

The default selection field allows the user to specify the pachymetry acquisition screen default layout. Four modes are available

Center only Automatic Continuous Scanning


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b) Mapping

The values indicated below are pre-defined mapping layouts. The mapping layout specifies the acquisition sequence for pachymetry.

-9C8L9C4L5C8L5C4L9C5C8L4L

C: measurement on a 3mm diameter circle centred on a central point (C0). L: measurement on a 6mm diameter circle centred on a central point 0.

NOTE If a sequence contains C spots, the first one is always C0 corresponding to the measurement of the central point. The following 8 figures show all the pre-defined mapping sequences for pachymetry acquisition:

To create a mapping sequence, press:

Click on “Clear All” button to erase all points (except C0) and start a new sequence

Click on each points to select or unselect the points. When finished: select “Quit sequence” and confirm the modifications.


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c) Measurement number

This parameter defines the number of measurement for the mode: “Center Only”. Enter a number between 1 and 10. The “Center Only” acquisition screen will then display as many measurement lines as specified. NOTE It is recommended to define at least 5 measurements in order to have an accurate average value.

d) IOP

This parameter defines the IOP correction table to be used. Select the appropriate table.

There are 3 pre-defined correction tables: Ehlers Doughty Dresdner

To visualize the different tables, select the IOP button:

You can create a new table or modify/delete an existing one (except for the 3 pre-defined tables):

EHLERS Correction table

DRESDNER Correction table

Pachymetry (µm)

Correction (mmHg)

Pachymetry (µm) Correction (mmHg)

445 7 555 -1 455 6 565 -1 465 6 575 -2 475 5 585 -3 485 4 595 -4 495 4 605 -4 505 3 615 -5 515 2 625 -6 525 1 635 -6 535 1 645 -7 545 0


460-485 +3 486-512 +2 513-536 +1 537-562 0 563-587 -1 588-612 -2 613-637 -3


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DOUGHTY Correction table

e) Velocity

This parameter defines the ultrasound speed in the corneal tissue. The default value is 1620 and this field accepts values comprised between 500 and 4000m/s included, which can be entered from the numeric pad.

f) Bias Value

This parameter defines the correction value of the measured corneal thickness. It can be from 0 to 120 and can be entered from the numeric pad.

g) Bias operator

This parameter defines the type of correction which will be applied to the bias value. Press the field to select a value:

h) Freeze

This parameter defines the acquisition measure mode. It can be “Easy”, “Medium” or “Hard”.

i) Buzzer

This parameter switches the acquisition beep to ON or OFF.


405 7 425 6 445 5 465 4 485 3 505 2 525 1 545 0 565 -1 585 -2 605 -3 625 -4 645 -5 665 -6 685 -7 705 -8

Per cent Apply the bias value correction that is specified in percentage. Plus Add the bias value to the measured value of the corneal thickness. Minus Remove the bias value from the measured value of the corneal thickness.


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

Press the Patient file icon:

• To search for a patient name type the first letter of the patient last name in the last name field: the list of patients with this initial will be displayed in a pop up window on the right hand side of the screen.

• Type ‘*’or ‘%’ to display the patient list with all names. NOTE: To display the patients list, the fields in the Patient screen have to be empty. If not, click on the Next patient button to erase all data in the patient screen fields and then type ‘*’or ‘%’ to display the patient lists.

• To access a patient file, select the patient name in the displayed list on the right hand side of the screen.

• To create a new patient, enter all patient data in the empty fields (Last name, first name, identification number and/or birth date) and save.

• To enter more information (gender, address and phone) press the More Patient Information button.

• To delete the patient, press the More Patient Information button and then on Erase patient file.

When selecting a patient, the following screen is displayed:

CAUTION: If a patient file is erased, all corresponding exams will be deleted.


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NOTE To close a patient file and open a new one, press Next Patient button: this will reset the patient file (empty the fields) as well as the examinations screens. However, it will absolutely not erase anything from the previous patient stored data (listed in his exam history).

5.1. Keratometry The right and left eye keratometry measurements are in different fields. For each eye, two keratometry values can be entered: enter the K1 value and eventually the K2 values if values are different. When leaving either one of the keratometry fields (by selecting an other field), the average K calculation is performed and displayed. NOTE: The possible range for Keratometry is 5 to 13 mm (or 25 to 68 Diopters). K1 and K2 must be entered in the same unit mm or Diopters.

CAUTION: Users of the Haigis Formula: It is necessary to enter the keratometry in mm, especially if the index value, used by the keratomerter is not known. If the values are entered in Diopters, the following warning message will be displayed: Warning: the K values have to be filled in mm to use Haigis Formula

5.2. Keratometry for post-refractive surgery cases By default, the Patient screen displays the “normal” case where classical Keratometry measurements can be entered. When selecting the icon:

The lower part of the screen “opens up” to enter more patient information used for post refractive calculations:

Pre-Op Keratometry. Pre-Op Refraction Post-Op Refraction. Contact Lens Curve Refraction with the Contact Lens.

NOTE: The Post-Op Refraction should easily be determined using the last spectacles correction.


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NOTE: The actual refraction may be modified by a cataract: in this case, the direct evaluation can be altered. NOTE Only known information should be entered: different methods and formulas are then available, depending on the existing patient information. For more information, please refer to the:

Section 6.1.2.5 – IOL calculation / b – Post Refractive IOL calculation

Compact Touch User Manual: Chapter V – Appendix: IOL formulae

5.3. Exam history Select the following button to obtain the list of all exams performed for the selected patient:

It is then possible to:

Recall an exam (with the original parameters used during the scan). These parameters cannot be modified. Press “Load Report” button.

Modify an exam (all parameters will be initialized and only default parameters of the selected physician will be available). Press “Modify Exam” button.

The operator name for the selected exam is displayed at the bottom right of the Exam History page at “Scan performed by:”

To delete an exam, select:


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CAUTION: When an exam is recalled in the exam screen (by using the “Modify Exam” function) all the parameters have to be checked or selected again (the value can be set to 0) by the physician because the current parameters may be different from those used during the exam (for example Eye Types, Vitreous Type, IOL references, IOL formula, method, IOP formula…). If the physician wants to see the exam in the original format (with the parameters used during the exam), he has to use the “Load Report” function and not the “Modify Exam” function.

5.4. Implanted IOL Press the Implanted IOL button to adjust the implanted IOLs for each eye.

An IOL calculation has to be performed to choose the desired IOL Exam in the pull-down menu (independent for each eye).

Press the “New OD Impl. IOL” button to enter the data of the implanted IOL for the right eye (press “New OS Impl. IOL” button for the left eye) The following data information can be entered:

• Power (D) • Target Ametropia (D) • IOL Ref. • Formula and Post-op refraction SE (D) (spectacles and cornea)

Press “Del OD Impl. IOL” to erase an existing implanted IOL for the right eye

(press “Del OS Impl. IOL” for the left eye).

5.5. More information The patient “More information” screen allows the user:

• to enter more patient information, • to delete a Patient using the “Erase Patient file” function from the bottom bar.


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6. ACQUISITION SCREENS (USING THE OPTIONS)

6.1. Biometry 6.1.1. A-Probe preparation

The probe must be cleaned between 2 patients to avoid contaminations: see chapters: Compact Touch User Manual: Chapter I - Regulatory and safety information Section 2-3 – How to prevent a transfer of infection

The cornea should be anaesthetized. In contact technique:

The probe will be placed directly, smoothly, on the cornea, at the center. The tear film should be sufficient to make contact for the ultrasound transmission.

The contact must be very light, no hard pressure on the cornea.

CAUTION: Make sure the calibration of the probe is correct: Compact Touch User Manual: Chapter IV - Maintenance Section 2 – Measurement test - Calibration

In immersion technique: The immersion technique involves the use of scleral shells:

Different diameters are available depending on the diameter of the patient’s cornea (from children to myopic eyes).

Choose the appropriate size. The shell must be placed directly on the sclera over the limbus. Fill it with physiologic serum or BSS. Position the probe in the liquid, close to the cornea, in the visual axis.


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6.1.2. Acquisition in biometry mode

6.1.2.1. Functions description

Press the icon:

The following screen is displayed when no measurement is in process:

For each parameter function (OD/OS to Technique), the selected choices are displayed at the top of the screen.

Parameters:

OD / OS - Right eye - Left eye

Probe Selection - Bio - Probeam - B10

Note: Select the correct probe to be used or else measurements will wrong

Eye Type - Phakic - Aphakic - Dense/Long - PMMA

- Acrylic - Silicone - Others created by the user.

Vitreous Type - Normal eye. -Silicone filled eye

Mode - Manual - Auto - Auto + Save

Technique - Contact - Immersion

To activate the probe and get a scan, press the footswitch or the following icon:

If the ProBeam is used, the laser aiming beam is ON. Ask the patient to fix the red point projected on the wall (or on the ceiling).


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When an exam is in process, the following screen will be displayed: When an exam is in process, the examination screen is separated in two different areas: 1. Image area (Area1) 2. Result area (Area2)

When clicking on one or the other area, the available contextual functions are different: Contextual functions of the examination screen: When clicking on Area1, the available contextual functions are:

When clicking on Area2, the available contextual functions are:

Previous Marker Used to select the Previous Marker New Marker Used to select the Next Marker Ignore / Include Used to ignore or include the selected line in calculations

Result Choice The selected result (result line, average or Stat 2) will be used for the IOL calculation

Erase All To erase the results of the selected eye Eye Type To modify the Eye Type Vitreous Type To modify the Vitreous Type

The knob allows the user to:

During acquisition: Adjust the default gain (when the Area1 is selected)

On a frozen image: - Adjust the position of a selected marker (highlighted in red) when the Area1 is

selected. - Select the previous or next line in the result table when the Area2 is selected.


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NOTE: Right click on the mouse when the cursor is positioned on an image to display the following menu:

Copy To copy the image in the clipboard of Windows Export to jpg To save the image in jpg format Background color To modify the background color of the image Selected color To modify the color of the selected markers, tool.

Cineloop color To modify the background color of the image when the Cineloop is activated.

6.1.2.2. Automatic acquisition

Press the icon or the USB footswitch to get an unfrozen image with the emission echo. (If the ProBeam is used, the laser aiming beam is ON: ask the patient to fix the projected red point).

The Compact Touch program is set to automatically freeze a measurement in Auto Mode when the conditions explained in the next paragraph are met (6.1.2.3 Conditions for automatic acquisition). NOTE The user may inhibit the automatic detection by pressing the footswitch until the probe is in a good position. NOTE Although using the automatic mode, it is the operator’s responsibility to check the accuracy of the measurements.

AUTO MODE


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6.1.2.3. Conditions for automatic acquisition

The Compact Touch software is set to automatically freeze a measurement in AUTO mode when the conditions explained below are met:

Threshold level & retina slope test Scleral Echo detection

The green dotted line is representing the minimum threshold the echoes should reach for automatic acquisition. Moreover, the acquisition software has also been designed to freeze the A-scan when the probe direction is in the visual axis: i.e. the rising edge of the retina should be as much perpendicular to the base line as possible. To reach this goal, the retinal spike sharpness criterion is tested.

In Automatic mode, in addition to the Retina Slope Test, the presence of the scleral echo is expected. Its amplitude must be above the threshold. It is the case if the probe is aligned with the macula. If the scleral spike is not detected, the probe is aligned along the optic nerve, which is not a correct position. Exception: in «Dense/Long» mode, the sclera criterion is not tested (in this case, it is difficult to be perpendicular to the retina and sclera)

6.1.2.4. Manual acquisition

To freeze while in manual mode, press the foot switch. The program is set to recognize the eye shape and to set the four markers automatically. If the correct criteria are not found, no markers will be set and the different segments will display zero. The user must then set the markers manually or try freezing again.

Saving the frozen scan: The scan may be saved by pressing the save key or pressing the pedal for more than one second


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6.1.2.5. Result table / Stat-2 calculation

Example:

Once the ten measurements have been performed, the system automatically selects the line for which the total length is the closest to the average total length value (see line 9 in the result table example).

If the is called from this page, the selected results (result line with the activated checkbox: will be used for the IOL calculation. Stat-2 calculation:

For Biometry.measurements done in Contact Technique, the longer anterior chamber corresponds to the exam done with the lowest pressure applied on the eye.

The smallest vitreous corresponds to the exam done with the sharpest retinal slope (where the probe’s position is at its best).

The “Stat-2” can combine the 2 echograms considering the following segments: [the longest value of (Ant.Chamber+Lens]+[the shortest vitreous length].

For example in the above table The longest value of [Ant. Chamber+Lens]: see line #2

2.82+3.41=6.23mm The shortest vitreous length: see lines #3 and #10: 18.29mm.

NOTE: When a line is ignored in the table, it is possible to include it again by pressing:

If the physician starts a new acquisition, the system considers that the ignored A-Scans are to be replaced by new ones. Then, the corresponding A-Scans are erased.


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6.1.2.6. IOL calculation

Select the IOL icon once the series of measurements is achieved:

The IOL calculation screen will then be displayed. NOTE: Make sure keratometry values (for standard or Post Refractive surgery cases) have been filled in the patient file.


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The following screen with 4 IOLs results tables is displayed:

a) Standard IOL calculation

A. IOLs selection The default IOLs will be displayed upon opening the IOLs calculation screen. It is still possible to choose different IOLs from the drop-down menus in each of the 4 tables. NOTE: After pressing the “Next Patient” button on the Patient file, the default IOL will be re-selected.

B. Formulae selection The default formulae will be displayed upon opening the IOLs calculation screen. It is still possible to choose different formulae from the drop-down menus in each of the 4 tables. The 6 available formulas are:

NOTE: When creating a new patient, the default formulae of the selected physician will be automatically re-selected. NOTE: For more information about IOL formulae, please refer to the: Compact Touch User Manual: Chapter V - Appendix: IOL formulae

A. IOL selection B. Formula selection

C. Post-operative ametropia

D. Increment


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C. Post-operative ametropia Select the Ametropia field in the IOL calculation screen. The ametropia values must be comprised between -20 and +20 dioptries. Enter the numeric values with the Keyboard or by turning the knob. Then the software calculates the refraction table centering the closest value to the desired refraction. NOTE: The AME value modification in the 1st column changes the 3 other AME fields with the same value. Those are independently modifiable.

D. Increment IOLs can be incremented by steps of 0.25 or 0.5.

b) Post Refractive IOL calculation When the post refractive surgery case is selected in the patient file, the chosen PR method can be selected from the Method drop down list:

NOTE: For more information about PR IOL calculations and methods, please refer to: Compact Touch User Manual: V - Appendix: IOL formulae NOTE: When entering the IOL calculation screen, the method selected by default is the method previously selected in the user file. In the case the method is modified: after pressing the “Next Patient” button in the Patient File, the default method is re-selected.

c) Saving the IOLs results To save the results, select:

NOTE: In case (OD/OS) IOL calculations have been done, (OD/OS) results are saved.


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d) Printing the IOLs results

Press the following button to pre-visualized the report on the screen: Press the Print button to print it out

NOTE: If calculations have been done for both eyes (OD/OS), both exams will automatically be printed on the same page. NOTE: It is not necessary to save the results to print them out.

6.1.3. Biometry guided by B-Mode (Compact Touch B and AB) This feature requires an activation keycode. Please contact QUANTEL MEDICAL or your local distributor for details on how to order this option and get an activation keycode.

To carry out this examination, the patient has to be lied down. The easiest location for the examiner is to be behind the patient’s head and have the Compact Touch unit in front of him.

Performing a biometry in B-mode procedure:

From the startup page, select the biometry icon:

Then, select the following function to choose the B10MHz probe:


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After having selected the physician, operator, OD/OS, Eye Type and Vitreous Type for the examination, press the footswitch to activate the B probe. Using either ophthalmic gel directly on the cornea, or the scleral shell technique, place the probe on the corneal vertex with the probe marker in the nasal or temporal position. Find the macula and cornea. When the scan is complete, push the footswitch and finally select the best loop scan (by using the loop function). When the appropriate scan is obtained, press the footswitch to freeze.

CAUTION: Be careful not to exercise any pressure on the cornea when measuring axial length. Verify that the CV line is well positioned: it should go through the center of the cornea and lens and then it should reach the macula. The position of the CV line can be modified if necessary: left click on the mouse to select the line (it turns from yellow to red color). Move the CV line up or

down. Left click again to set the final position (or select the field and use the knob to modify the position of this CV line) The markers position can also be modified if necessary: refer to: Section 6.1.2.1: Functions description.

The button is displayed at the bottom right of the screen when the AREA1 (picture area) is selected. Select this button to add the measurements from the selected loop to the table. Repeat the measurements several times to

get an average. Then press the button to get the IOL calculation results table. Save the results.


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6.1.4. Footswitch functions for A mode (review)

The table below summarizes all footswitch functions for the two states of acquisition (frozen image / unfrozen image) in A-mode:

NOTE: Concerning the footswitch functions for the Bio Mode guided with B10 Probe, please refer to the table “Footswitch functions for B-mode: Section 6-2-4: Footswitch functions for B Mode (as well as for Bio Mode guided with B10 probe)

State of acquisition Unfrozen image (during

acquisition) Frozen image

Action on footswitch

Short pressure (less than 1s)

Long pressure (more than 1s)



Manual Freeze image Unfreeze the image

Save (even if result table is not filled)

Auto+Save No action

Inhibition of the automatic

acquisition

Unfreeze the image (if the result table is

not filled)

Save (when result table is filled)

Auto Include or ignore the results

or Save (when result table is filled)


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6.2. B-Scan This feature requires an activation keycode. Please contact QUANTEL MEDICAL or your local distributor for details on how to order this option and get an activation keycode.

The 10 MHz B-scan probe is focused at about 25mm (to create images of the eye and orbit). It can be used directly on the eyelid:

Place some gel on the lid Place the probe on the eye Ask the patient to look in different directions to reach certain zones on the globe

CAUTION: Placing excessive pressure on the B-scan probe will cause discomfort to the patient.

6.2.1. Functions description To display the acquisition screen for B mode, select:

Without Patient name With Patient name and recorded exams

The available contextual functions are different from Area1 to Area2

When clicking on the picture of Area1, the available contextual functions at the bottom of the screen are:

When clicking on the pictures of Area2, the available contextual functions at the bottom of the screen are:


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• When selecting the icon :

• When selecting the icon :

Functions description

The knob allows the user to: - adjust the default gain (during acquisition when the

Area1 is selected) - adjust all the numeric fields as described in the next

functions (Gain, Dyn, TGC and Zoom fields) - select the desired image from the Cineloop sequence

as described in the next function: Loop - adjust the position of the CV line as described in the

next function: CV

Eye selection (by default OD is displayed when creating a new patient)

When selecting one of those numeric fields, use the numeric keyboard or use the knob to change values. See below the default values (if the values have not been modified in the “B Setup” screen of the Physician file): Gain:90dB, Dyn: 50dB, TGC:10dB and Zoom: 130

This icon allows the user to obtain a full screen image (the default zoom is set to 130)

This icon allows the user to resize the image to the default zoom (which is set in the physician file: by default 130 in 1/1 and full screen). The image is also centered in the middle of the screen.

This icon allows the user to display the Cineloop sequence

This icon allows the user to save the Cineloop sequence

The loop value can display up to 100 images. The loop value is increasing during the examination. By default, the loop value is “0/0” when accessing the examination screen

To display the Cross Vector line (CV) on a B mode image, press on the corresponding icon. Selecting the numeric field and changing the value allows the user to move the CV line up or down


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Functions description (next…)

Slow speed (sweeping frequency = 9Hz):

Fast speed (sweeping frequency = 16Hz):

Two transducer sweeping frequencies are available with the 10 MHz probe. By default, the slow speed is selected This function is not available in Biometry guided by B mode. Depending on the Compact Touch configuration, this option may not be accessible.

This icon allows the user to start and stop the acquisition (the probe is activated or stopped)

This pull-down menu allows the user to select the physician who is performing the exam

This pull-down menu allows the user to select the operator who is performing the exam

When choosing one or the other of these icons, you will then be able to access 2 different menus:

This icon allows the user to display the exam list with: • the recorded images • the recorded loop sequences

This icon allows the user to display the “Tools” table (with the calipers) for the image with the corresponding measurements


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6.2.2. Add to report / Remove image from report The image of AREA 1 as well as the miniature images of AREA 2 can be added to / removed from the report by selecting the following icons at the bottom of the screen:

or When “Add to Report” is selected, the “Add to Report” icon is added at the bottom right of the miniature image:

If the report is previewed / printed, all miniature images (saved images) containing this “add to report” icon are incorporated. NOTE: In case the image is not saved, when selecting the “Add to report” function, the image is automatically added to the report.

6.2.3. Mouse right click functions • By right clicking on the mouse on the displayed image of AREA 1, a menu

appears with the following choices:

• By right clicking on the mouse on the miniature images of AREA 2, a menu appears with the following choices:

Copy To copy the image in the clipboard of Windows

Export to jpg To save the image in jpg format

Background color To modify the background color of the image

Selected color To modify the color of the selected markers, tool.

Cineloop color To modify the background color of the image when the Cineloop is activated.

Delete image To delete a saved image Add to report To add an image to the report. Remove from report To unselect an image that was previously added to the

report. Clear report Allows the user to unselect all images that were

previously added to the report.


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6.2.4. Footswitch functions for B Mode (as well as for Bio Mode guided with B10 probe)

The table below summarizes the footswitch functions for the two states of acquisition (frozen image / unfrozen):

6.2.5. Cineloop sequence The Cineloop allows recording a video sequence corresponding to the last 10 seconds of examination before freezing (up to 100 images). The user can review the whole sequence on loop or as individual images. Press the footswitch to complete the acquisition. The duration of the saved Cineloop appears on the left hand side of the screen.

• To review the whole sequence: Pressing the following button allows the user to start the automatic image sequence:

Press the same button again to stop the sequence.

• To review the sequence image by image, press the loop field: and turn the knob to select the desired image

• To save the sequence, press on the following icon:

The window hereby is displayed:

The sequence can be saved in:

The AVI format: file that can be read with Windows Media Player (for example).

COMPACT TOUCH format: that can be read with the COMPACT TOUCH software only.

State of acquisition Unfrozen image (during acquisition) Frozen image

Action on footswitch Short pressure (less than 1s)




Allows the user to Freeze image or acquisition Unfreeze the image Save


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NOTE: It is possible to record the whole sequence by selecting “ALL” or only a part by using the “Select” checkbox. Choose the first and last image of the sequence you wish to record.

CAUTION: When recording Cineloop sequences in Compact Touch format, the backup size is very important.

6.2.6. Post processing To access the tool bar view and Post Processing result table on the right side of the screen, select:

The following list of available tools is displayed at the bottom of the screen:

A comment may be entered in the “Comment” field for each selected tool. A text that corresponds to the saved exam may be entered and saved in the “Text entry” field.

NOTE To delete a tool, select it from the post processing result table and select:

The following functions are also available to the user:


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6.2.6.1. Caliper (To measure a distance)

To use the caliper function, select:

Place the pointer over the desired location on the picture and left-click on the mouse to freeze its position. Repeat this procedure to place the second marker. The caliper reference “C#” is displayed for each point:

The “C#” reference and corresponding measurement are displayed in the tools result table. Comments can be added in the comment field: click and type in some text.

To move the caliper:

Left click on the caliper to be moved (the selected caliper will be highlighted in red). Release the mouse button. Move the mouse to reposition the caliper. Left-click again to validate the new position.

6.2.6.2. Marker (To indicate a particular point on the image and give comments)

To use the marker function, select:

Position the pointer by left-clicking to set the front part of the arrow. Adjust the arrow direction and left-click to validate final position. The marker reference “M#” is displayed next to the marker on the image.

The reference “M#” is displayed in the list of the tools result table. Comments can be added in the comment field: click and type in some text.

To move a marker:

Left click on the marker to be moved (the selected marker will be highlighted in red). Release the mouse button. Move the mouse to set the new marker position. Left-click again to validate the new position.


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6.2.6.3. Area (To draw a field and calculate the surface area)

To use the area function, select:

Position the pointer over the desired location and left-click to set the first point. Repeat as necessary to surround the area to be selected. Right-click to validate the final point. The area reference “A#” is displayed next to the first selected point:

The reference “A#” with result is displayed in the tools result table. Comments can be added in the comment field: click and type in some text.

To move a point on the area selection:

Left click on the point to be moved (the selected point will be highlighted in red). Release the mouse button. Move the mouse to set the new area point position. Left-click again to validate the new position.

NOTE (common to all tools) When multiple markers or points (of a caliper, marker, area) are nearly positioned on top of one another, a question mark will be displayed when trying to select one of those with left clicking on the mouse. To choose which one to select, right-click several times on the mouse to move the selection from one to the other until the correct one is selected and then left click again to move it around.


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6.3. Pachymetry This feature requires an activation keycode. Please contact QUANTEL MEDICAL or your local distributor for details on how to order this option and get an activation keycode.

Remove the pachymetry probe from the probe holder. Clean the tip as indicated in chapter: Compact Touch User Manual: Chapter I - Regulatory and safety information Section 2-3 – How to prevent a transfer of infection

The cornea has to be anesthetized. The probe has to be directly placed on the cornea. The tear film should be sufficient to make contact for the ultrasound transmission.

NOTE: If no acquisition is possible, drop some physiologic serum on the patient cornea.

CAUTION: Be careful not to exert any pressure on patient cornea.

Select the icon:

The screen corresponding to the Acquisition Mode selected by default in the Pachymetry Setup screen (accessible from the Physician Setup screen) appears. The acquisition mode can be selected among the dropping list which follows:

The following menu is displayed at the bottom of the pachymetry screens:

Functions description:

To start the pachymetry acquisition, press the footswitch or the following icon:

OD / OS Eye selection (by default OD is displayed when creating a new patient) Erase All Erase all the measured values Acquisition mode Switch to the acquisition mode (Center Only, Automatic, Continuous,

then Scanning) Freeze Select a type of freeze (easy, medium or hard)


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6.3.1. Acquisition mode: Center only The measured values will be displayed in the CTT column. The average, min, max and standard deviation will be calculated and displayed in the results table (right side of the screen).

With existing measurements, the following functions choices list is displayed at the bottom of the screen:

A specific measured value can be “ignored” by pressing the “Ignore” button on the highlighted line. The Standard Deviation, Average, Min and Max values will be calculated again. To include an ignored value, select the line and select the “Include” button.


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6.3.2. Acquisition mode: Automatic

The measured values will be displayed sequentially in the mapping layout. After each measure, the cursor will automatically move to the next position and acquisition is active until the last measurement. For each measure, the current value and the bias value are displayed on the left side of the screen.

6.3.3. Acquisition mode: Continuous The measured values will be displayed sequentially in the mapping layout. Acquisition continues while the probe is in contact with the cornea. Lift up the probe to move to the next measure. For each measure, the current, bias, mini and mini bias value are displayed on the left side of the screen.

NOTE: The layout of the screen for Automatic and Continuous modes depends on the setup of the mapping parameter choosing in each physician setup (Section 4.2.4. – Pachymetry setup).


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6.3.4. Acquisition mode: Scanning Depth Alert field: By pressing the Depth Alert field, the numeric keyboard is automatically displayed to enter a limit value.

The measured values will be displayed on the left side of the screen: current, mini, maxi and the equivalent bias values. Press again this key or the footswitch to stop the acquisition.

NOTE: When the measured value is lower than the specified Depth Alert value, this field will blink and a beep can be heard. Press the footswitch to exit and stop the alert.


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7. PRINTING The COMPACT TOUCH allows the user to print reports from the following screens:

Biometry IOL Calculation IOL table Pachymetry B mode Exam History

For the acquisition screens (A mode (and Bio B), B mode and pachymetry) and IOL calculation screens, the user can decide to print on a Video printer or on a Windows

printer. Select the icon to display the following printer selection screens :

A, Pachy and IOL calculation modes B mode

The user can choose to: Automatically print the reports on the Windows printer selected by default. When

the exam report is printed on several pages: the patient last name, first name and ID are displayed on all pages. For B mode, all the images previously selected will be printed two images per page.

Allows the user to choose the USB Video printer on which he wants to print its reports (A6). This choice is only available if the Video printer option has been validated in the General Setup screen.

Preview the report before printing. “Clear report”: to unselect all pre-selected images from the report. “Close Window”: allows the user to close the printing window without printing, nor

unselecting the report images.


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7.1. Printing from the biometry mode acquisition screen From the Biometry exam screen, perform an acquisition and then press the icon:

.

From the printer selection screen, select the “Print on Windows printer” or “Print on USB Video printer”.

By using the “Preview Report” function: the report will be displayed on the

screen. Click on the function: to print it out.

Select “Print on Windows printer” or “Preview Report” and then “Print”:

“Print on USB Video printer”

NOTE: With a Windows compatible printer: if the measurements have been performed on both eyes, the results will be printed out on the same page With the USB video printer, only the eye displayed on the screen will be printed with the A6 format.


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7.2. Printing from the IOL calculation screen: Select a measurement in the Biometry exam screen, and then select the IOL

icon to access the IOL calculation screen. Press the icon: .

From the printer selection screen, select the “Print on Windows printer” or “Print on USB Video printer”. By using the “Preview Report” function: the report will be displayed on the


Windows printer :

1: The line shows the measurement corresponding to the displayed curve. By default, the displayed curve corresponds to the measurement where the total length (TL in mm) is the closest to the average TL (mm). If the IOL calculation was performed from a specific axial length measurement selected from the results table, the curve and IOL calculations will then correspond to this selected line.

2: This line corresponds to the result chosen by the user in the IOL calculation page. It can either correspond to:

- The average - The chosen line that has been selected in the result table by the user

- The (TL and AC) values which can be modified by the user in the IOL screen.


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USB Video printer

7.3. Printing from the B mode examination screen Perform an acquisition from the B mode exam screen. Press the following icon:

. From the printer selection screen, select the “Print on Windows printer” or “Print on USB Video printer”. By using the “Preview Report” function: the report will be displayed on the


Windows printer USB Video printer


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7.4. Printing from the Pachymetry mode examination screen

Perform Pachymetry measurements. Press the following icon: .

From the printer selection screen, select the “Print on Windows printer” or “Print on USB Video printer”. By using the “Preview Report” function: the report will be displayed on the


Windows printer USB Video printer

NOTE: The printing will only show the current eye result table (even if both eyes have been measured)


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7.5. Printing from the exam history In the Patient screen, select the “Exam History” function. Select the exam to print and click on the “Load Report” function. Press the

following icon: .

The report is displayed on the screen. Select the function to print it out.

7.6. Preview report

When selecting the following icon , the user can decide to « Preview the report ». Once the report is displayed on the screen, the contextual available functions at the bottom of the screen are:

Functions description:

7.7. Export in Excel, PDF or Word format Choose to export reports in EXCEL, PDF or WORD format by selecting the disk icon in the menu at the top of the screen:

NOTE: It is recommended to export the reports with PDF format. Indeed, depending on the operating system and Word / Excel software version, the page layout may be altered when exporting the reports with Word or Excel.

Print Allows the user to select the printer and print the report. Previous / Next Page Allows the user to display the previous / next page of the report Close Selecting “Close” allows the user to cancel the report. All images

previously added to the report are unselected.


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User Manual: IV - Maintenance



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


2008

Directive 93/42/EEC


CONTENTS

1. ARCHIVE DATA BASE ...................................................................................... 1

2. MEASUREMENT TEST / CALIBRATION .......................................................... 1

2.1. Biometry probe calibration .......................................................................... 1 2.1.1. Calibration check:.......................................................................... 2 2.1.2. Calibration adjustment .................................................................. 3

2.2. Pachymetry probe calibration ..................................................................... 4

3. CARE OF THE UNIT .......................................................................................... 5

4. CARE OF THE DIFFERENT PROBES .............................................................. 5

COMPACT TOUCH User Manual: IV – Maintenance

12-06-2012 1

1. ARCHIVE DATA BASE This function allows the user to automatically save all Compact Touch data (including calibration, physician setup information, patient files, examinations…) on the computer or on an external memory system.

In the General Setup screen, select “Save all data”:

A window will open up allowing the user to select the backup folder location and name.

A folder named “Data” is created. It contains two backup folders: Touch data and Touch Xml

A text file containing the backup date is created as well.

CAUTION: It is recommended to perform a database backup on a regular basis as well as before any modification or unit servicing.

2. MEASUREMENT TEST / CALIBRATION 2.1. Biometry probe calibration

If the biometry probe needs to be exchanged on the Compact Touch unit, it is necessary to re-calibrate the unit with the new probe:

The thickness of the biometry probe membrane (located at the tip of the probe) is varying slightly from a biometry probe to another. As a consequence, if the contact method is used: the distance between the probe’s transducer to the point where the probe is in contact with the eye is varying as well. It is then necessary to perform a calibration to get correct biometry measurements. Calibrating the biometry probe consists of performing an acquisition on the test block (located on the front panel) and then to adjust the “Position of marker #1 in Contact (mm)” value as described below in Section 2.1.2 – Calibration adjustment.


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2.1.1. Calibration check: 1) From the Startup screen: press the “General Setup” function 2) In the General Setup screen, select the “BIOMETRY MODE” (or the

“PROBEAM MODE”) field (probe for which the calibration has to be done):

3) Once selected: a new function is displayed at the bottom of the screen (“Biometry Test” or “Probeam Test”):

Select the function. A new window pops up in the middle of the screen:

4) Put a drop of water on the Test-Block and adjust the probe’s position on the test block to be as much perpendicular and well centered as possible. The Test-Block has a rounded shape that slightly matches the concave tip of the probe:

OR


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5) A tracking starts: the purpose is to record the measurement that has the highest posterior face echo. This measurement will correspond to the best position, well perpendicular to the posterior face. The purpose is to check the Test-Block measurement. The “Best” should be comprised between:

10.00 < Best < 10.11 mm This value is calculated with the average velocity of 1550 m/s

Select “Clear” to erase the “Best” and “Current” fields and start a new measurement.

2.1.2. Calibration adjustment In case the measurement is not comprised between 10.00 and 10.11, the marker has to be modified to get the correct value:

1. Press “Clear” to erase the values in the “Best” and “Current” fields, and to start a new acquisition for the best position.

2) Select the “Position of Marker#1 in contact” field and use the potentiometer to adjust its value so that the Best and Current values are corrected the accepted range:

The “Best” is not comprised between: 10.00 < Best < 10.11 mm


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3) Press OK button to validate, save the calibration and close the window. The “Position of Marker#1 in contact” value is then corrected in the General Setup screen:

From now on, the biometry measurements when using the contact technique are correct.

CAUTION: If both Biometry probe and a ProBeam are in use, it is necessary to perform the calibration for both probes. Select the appropriate probe in the biometry screen and perform the calibration corresponding to the selected probe.

NOTE This correction is affecting the Anterior Chamber depth measurement when doing the acquisition in CONTACT technique only! With the IMMERSION technique, this correction does not apply. With the IMMERSION technique, the first marker is set on the corneal echo, far from the emission spike.

2.2. Pachymetry probe calibration

CAUTION: When changing pachymetry probe: it is recommended to perform a new calibration to improve the acquisition process. Contact QUANTEL MEDICAL Service Department or your local distributor.


12-06-2012 5

3. CARE OF THE UNIT

CAUTION: Disconnect the power cord before cleaning the unit case

CAUTION: Only use a damp cloth for cleaning Do not use any solvent or alcohol

WARNING Some people may be extremely allergic to isopropyl alcohol.

4. CARE OF THE DIFFERENT PROBES Probes are fragile and should be handled with care They can be damaged if dropped onto hard surfaces. Regular check: Examine the cable and the body of the probe for cracks as they may allow penetration of conductive liquids. In case of any doubt about the probe, DO NOT USE IT and contact QUANTEL MEDICAL Service Department or your local distributor.

WARNING Do not autoclave the probe. Concerning the probe cleaning process, refer to: Compact Touch User Manual: I – Regulatory and safety information

User Manual: V – Appendix: IOL formulae



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


2008

Directive 93/42/EEC


CONTENTS

1. IOL FORMULAE .......................................................................................................... 1

1.1. USED VARIABLES ............................................................................................. 1

1.2. S.R.K.-II .............................................................................................................. 1

1.3. S.R.K.- T ............................................................................................................. 2

1.4. DOUBLE K / SRK-T (FROM DR JAIME ARAMBERRI) .................................. 3

1.5. BINKHORST II .................................................................................................... 4

1.6. HOLLADAY ......................................................................................................... 5

1.7. HOFFER-Q ......................................................................................................... 6

1.8. SHAMMAS .......................................................................................................... 7

1.9. HAIGIS ................................................................................................................ 8

2. IOL CALCULATION FOR POST REFRACTIVE SURGERY ........................................11

2.1. HISTORY DERIVED / DOUBLE K – SRKT METHODS (CASE 1: WHEN ALL THE PATIENT HISTORY IS KNOWN): ..........................................................12

2.2. REFRACTION DERIVED METHOD (CASE 2: ONLY THE REFRACTIONS ARE KNOWN): ..............................................................................................13

2.3. ROSA / SHAMMAS (CASE 3: UNKNOWN PATIENT HISTORY: CORRECTED K VALUE) ...............................................................................14

A. ROSA ...................................................................................................14 B. SHAMMAS ...........................................................................................14

2.4. CONTACT LENS METHOD (CASE 4: UNKNOWN PATIENT HISTORY: EVALUATED POST-OP K) ............................................................................15

COMPACT TOUCH User Manual: V – Appendix: IOL formulae

12/06/2012 1

1. IOL formulae

1.1. Used variables Used Variables for all formulae: AL: Axial length. K: Averaged dioptric power of the cornea = (K1 + K2) / 2. R: Corneal curvature in mm = 337.5 / K (K in Dioptres). ACD: Post-Operative Anterior Chamber Depth.

1.2. S.R.K.-II

Emmetropic Power: P = A - 2.5AL - 0.9K + C C = Correction to the first S.R.K. formula where C=0.

C values depending of the measured axial length: If AL < 20 mm then C = + 3 If 20 <= AL < 21 then C = + 2 If 21 <= AL < 22 then C = + 1 If 22 <= AL < 24.5 then C = 0 If AL >= 24.5 then C = - 0.5

SRK-II Ametropic Powers: With: P: Emmetropic power I: Desired implant power Rt: Target Refraction Rf: Refraction factor

Refraction = Vs (I): Rt = (P-I) / Rf where Rf = 1.25 if P > 14

Rf = 1 if P <= 14 IOL= Vs (Rt): I = P - (Rt.Rf) where Rf = 1.25 if P > 14

Rf = 1 if P<= 14


12/06/2012 2

1.3. S.R.K.- T

Retinal thickness: Rethick = 0.65696 - 0.02029 x AL Lc = AL except if AL > 24.2 Lc = -3.446 + (1.716 x AL) - (0.0237 x AL²) Kd = 337.5 / Rmm Rmm = 337.5 / Kd C1 = -5.40948 + 0.58412 x Lc + 0.098 x Kd Rc = [Rmm² - (C1)² / 4] If Rc < 0 then Rc = 0 C2 = Rmm - SQRT [Rc] ACD = 0.62467 x A - 68.74709 where A = SRK Constant ACDE = C2 + ACD - 3.3357 n1 = 1.336 n2 = 0.333

L0 = AL + Rethick = 0.97971 x AL + 0.65696

S1 = L0 - ACDE S2 = n1 x Rmm - n2 x ACDE S3 = n1 x Rmm - n2 x L0 S4 = 12 x S3 + L0 x Rmm S5 = 12 x S2 + ACDE x Rmm

REF_X =(1336 x S3 − IOL x S1 x S2)

(1.336 x S4 − 0,001 x IOL x S1 x S5)

IOL_FOR_TGT =[1336 x (S3 − 0.001 x REFt x S4)]

[S1 x (S2 − 0.001 x REFt x S5)]


12/06/2012 3

1.4. Double K / SRK-T (From Dr Jaime Aramberri) Correction Axial Length: Lcor Lcor = AL except if AL > 24.2 Lcor = -3.446 + (1.716 x AL) - (0.0237 x AL²)

Corneal curvatures, 2 Keratometry values are used: Pre corneal refractive surgery:

Rpre = 337.5 / Kpre Kpre = 337.5 / Rpre

Post corneal refractive surgery: Rpost = 337.5 / Kpost Kpost = 337.5 / Rpost

Calculations with Kpre or Rpre:

Computed corneal width: CW CW = -5.40948 + 0.58412 x Lcor + 0.098 x Kpre

Corneal Height: H Rc = [Rpre² - (CW) ² / 4] If Rc < 0 then Rc = 0

H = Rpre - SQRT [Rc]

Anterior Chamber Depth Constant: ACDconst ACDconst = 0.62467 x A - 68.74709 where A = SRK Constant

Estimated Post-operatice ACD: ACDest ACDest = H + Offset where Offset = ACDconst - 3.3357

Constants: na = 1.336 V = 12 nc = 1.333 C2 = nc - 1

Retinal thickness: Rethick = 0.65696 - 0.02029 x AL

Optical Axial Length: L0PT = AL + Rethick = 0.97971 x AL + 0.65696

Calculations with Kpost or Rpost: S1 = L0PT - ACDest S2 = na x Rpost - C2 x ACDest S3 = na x Rpost - C2 x L0PT S4 = V x S3 + L0PT x Rpost S5 = V x S2 + ACDest x Rpost

IOL emme =1336 x S3(S1 x S2 )

REF_X =(1336 x S3 − IOL x S1 x S2)

(1.336 x S4 − 0,001 x IOL x S1 x S5)

IOL_FOR_TGT =[1336 x (S3 − 0.001 x REFt x S4)]

[S1 x (S2 − 0.001 x REFt x S5)]


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1.5. BINKHORST II Used Variables:

Lb: Axial length corrected for Binkhorst II.

Lb = LA + 0.1984 mm

ACD-b: Anterior chamber corrected only for POSTERIOR CHAMBERS.

If Lb < 26 then ACD-b = ACD x (LA / 23.45) If Lb >= 26 then ACD-b = ACD x (26 / 23.45)

So ACD-b = 1.1087 x ACD

R: Cornea curvature in mm = 337.5 / K (K in Diopters) Ref: Target Refraction. Lb: Corrected Axial length. AC: Post-operative Anterior Chamber.

AC = ACD for Anterior Chamber IOLs AC = ACD-b for Posterior Chamber IOLs.

FORMULA GIVING THE IMPLANT VALUE VERSUS THE DESIRED REFRACTION: REF IOL = Vs (Ref) if Ref =0 IOL= IOLem (emmetropia)

IOL =1336 [ 1.336R − 0.3333Lb − 0.001Ref (16,032R − 4Lb + Lb. R) ]

(Lb − AC) [ 1.336R − 0.3333AC − 0.001Ref (16.032R − 4AC + AC. R ]

FORMULA GIVING THE REFRACTION VERSUS THE DESIRED IMPLANT: IOLAM Ref = Vs (IOL)

Ref =1336(1.336R − 0.3333Lb) − IOL. (Lb − AC) (1.336R − 0.3333AC)

1.336(16.032R − 4Lb + LbR) − 0.001IOL(Lb− AC) (16.032R− 4AC + AC. R)


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1.6. HOLLADAY Used Variables: R: Cornea curvature in mm = 337.5 / K (K in Diopters) Ref Target Refraction. Lh: Axial length corrected for HOLLADAY. Lh = AL + 0.200 mm SF: Surgeon Factor: specific for Holladay formula. SF = (A x 0.5663) - 65.60 where A is the SRK Constant ACh: Anterior Chamber corrected for HOLLADAY. Rag = R exept if R < 7mm then Rag = 7 mm AG = (12.5 / 23.45) AL so : AG = 0.533.AL

except if AG > 13.5 then AG = 13.5 mm ACD = 0.56 + Rag - [SQRT (Rag² - AG² /4)] ACh = ACD + SF FORMULA GIVING THE IMPLANT VALUE VERSUS THE DESIRED REFRACTION (OR AMETROPIA): REF IOLam = Vs (Ref) If Ref =0 IOLam = IOLem (emmetropia) IOLam = 1336 [1.336. R − 0.3333Lh − 0.001Ref (16.032R − 4Lh + Lh. R) ]

(Lh − ACh) [1.336R − 0.3333ACh − 0.001Ref (16.032R − 4ACh + ACh. R]

FORMULA GIVING THE REFRACTION VERSUS THE DESIRED IMPLANT: IOLam Ref = vs (IOLam) Ref = 1336 (1.336R − 0.3333Lh) − IOLam(Lh − ACh)(1.336R − 0.3333ACh)

1.336 (16.032R − 4Lh + Lh. R) − 0.001 IOLam (Lh − ACh)(16.032R − 4ACh + ACh. R)


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1.7. HOFFER-Q Used Variables: P: Implant POWER (D) R: Refractive error at corneal plane (D). Rx: Desired ametropia : Refractive error at spectacle (D). K: Average Keratometry (D) CD: Corrected Chamber Depth (mm). ACD: Anterior chamber depth from the personalized IOL User file. AL: Axial Length (mm) CORRECTED CHAMBER DEPTH: If AL <= 23 M = +1 and G = 28 If AL > 23 M = -1 and G = 23.5 If AL > 31 AL = 31 If AL < 18.5 AL = 18.5 CD = ACD + 0.3(AL - 23.5) + (tan K) 2 + 0.1M (23.5 - AL) 2 tan [0.1(G - AL) 2] - 0.99166 EMMETROPIA POWER: R = Rx / (1 - 0.012Rx) P = [1336 / (AL - CD - 0.05)] - {1.336 / [(1.336 / (K + R)) - ((CD + 0.05) / 1000)]} FORMULA GIVING THE REFRACTION (RX) VERSUS THE DESIRED IMPLANT: IOLAM Rx = vs (IOLam)

R = [ 1.336 [1.336 / (1336 / (AL − CD − 0.05) − IOLam) + (CD + 0.05) / 1000]

]−𝐾 Rx = R / (1 + 0.012R)


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1.8. SHAMMAS KERATOMETRY CORRECTION: KS = 1.14 Kpost – 6.8 Where Kpost is the measurement of the Keratometry by classical means. IOL CALCULATION FOR EMMETROPIA IOLemm = (1336 / (L – 0.1 (L – 23) – C -0.05)) – (1 / ((1.0125 /K) – ((C + 0.05) / 1336)))

IOLemm = 1336 L – 0.1(L – 23) – C − 0.05

− 1

1.0125K – C + 0.05

1336

Where: L= Axial Length in mm K = Keratometry in Diopters C = ACD (Shammas) = 0.5835.A - 64.40 FORMULA TO CALCULATE THE IMPLANT CORRESPONDING TO THE DESIRED REFRACTION (R): IOL Am = Vs (R)

IOLAm = 1336 L – 0.1(L – 23) – C − 0.05

− 1

1.0125K + R – C + 0.05

1336

FORMULA TO CALCULATE THE REFRACTION CORRESPONDING TO THE IOL VALUE. Refr. = Vs (IOL)

R = 1336 − IOL (L – 0.1(L – 23) – C − 0.05)

L – 0.1(L – 23)1.0125 − (IOL (C + 0.05) (L – 0.1(L – 23) – C − 0.05)

1352.7

−𝐾


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1.9. HAIGIS Formulas for the IOL calculation according to HAIGIS (W. Haigis)

1. IOL power for given refraction Dl: All calculations are based on the "Thin-lens-formula":

(1) With:

(2) Where:

And: Dl IOL power Dc corneal power Rx desired refraction n refractive index of aequeous and vitreous (=1.366) Nc fictitious refractive index of cornea (=1.3315) Dx vertex distance between cornea and spectacles (=12 mm) R corneal radius L axial length (as measured by ultrasound) d optical ACD

2. Refraction Rx for given IOL power: From (1), the following equation for the resultant refraction Rx for an IOL power Dl and an optical ACD d:

(3) Where:

Dl = n nL - d n

z - d-

z = Dc +Rx

1 - Rx . dx

Dc =Nc - 1

R

Rx =q - Dc

1+ dx . (q + Dc)

q =n . [n - Dl . (L - d)]

n . (L - d) + d . [n - Dl . (L - d)]


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3. Optical ACD: d The optical ACD: d is given by the following expressions: If AC=0 then d = (a0 + u. a1) + (a2 + v. a1). L (4) else d = a0 +a1 . AC + a2 . L (5) with AC : preoperative acoustical anterior chamber depth, as

measured by ultrasound L: preoperative axial length, as measured by ultrasound and u : -0.241 v : 0.139 The parameters a0, a1 and a2 are constants describing the IOL.

4. IOL constants a0, a1, a2: In standard or default mode, the constants a0, a1 and a2 are given by: a1 = 0.400 a2 = 0.100 a0=0.62467 x A – 72.434 (6) with A: Lens constant provided by the manufacturer. In optimized mode, the constants a0, a1 and a2 are obtained by a separate optimization process. For each patient, the actual post-op refraction is used to calculate the corresponding optical ACD. For all patients, these values are then correlated with the pre-op ultrasound measurements of the (acoustical) ACD and the axial length. Double linear regression analysis yields the constants a0, a1 and a2. Global limitations: 1.16 < a0 + 3.37a1 + 23.39a2 < 7 1.16 < a0 + 2.53a1 + 20.00a2 < 7 1.16 < a0 + 3.50a1 + 27.00a2 < 7


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5. Examples: A-constant A=118.0 > a0 = 1.277; a1 = 0.400; a2 = 0.100; 1. L = 21.44; AC = 2.69; R = 7.45; target refr. Rx= -0.250 > d = 4.497; DL= 26.862 2. L = 23.27; AC = 3.14; R = 7.69; IOL implanted DL= 22.000 > d = 4.860; Rx= -0.398 3. L=27.09; AC = 3.48; R = 7.76; target refr. Rx = 2.730 > d = 5.378; DL= 5.768 6. Copyright notice: This description is © by W.Haigis, 1998-2000. It may not be used for publication, neither in total nor in parts, without the written consent of the author. Würzburg, Jan.25th , 2000; Dr.W.Haigis


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2. IOL calculation for Post Refractive surgery IOL calculations by classical means turned out to be wrong for a lot of patients who got a cataract few years after refractive surgery (RK, PRK ou Lasik), indeed:

The keratometry measured by classical means was over estimated. Using this K value, the calculated IOL power was underestimated and the

patient then got hyperopia after implantation. The goal of the “Post-refractive surgery cases” program is to:

Estimate the real curvature of the cornea. Calculate the correct IOL value.

Different methods and formulas are available depending on the available patient information such as:

Keratometry information:

Pre-op Keratometry Or actual Keratometry only

Refraction information: Pre-op & post-op Refraction Or post-op Refraction only

Available methods & formulae when historical patient data is known.

Available methods & formulae when historical patient

data is NOT known.

NOTE The post-op refraction can easily be determined using the last spectacles correction information. NOTE A cataract may affect refraction, so that a direct evaluation may be altered.

Historical Data is known

Pre-op Keratometry

Pre-op Refraction

Khd History derived

IOL All

formulae

IOL Double K/SRK-T

Only Pre-op Refraction

Current K Measurement

Krd Refraction

derived

IOL All

formulae

No Historical Data is known

Current K Measurement

TL Measurement

KR ROSA

IOL SRK-T

SRK-II if TL>29.4mm

KS SHAMMAS

IOL SHAMMAS

Refraction with Contact Lens

Kcl Contact Lens

IOL All

formulae


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2.1. HISTORY DERIVED / DOUBLE K – SRKT METHODS (Case 1: when all the patient history is known):

All the historical data of the Right Eye is available: Pre-Op Keratometry: 49.25D Pre-Op Spect. Refraction: -10.00D Post-Op Spect. Refraction: -1.00D

Correction on Corneal Plan = Post-Op Refr-Pre-Op Refr = 0.99-(8.93) =7.94

A. History derived method: Formula: Khd = Pre-Op K-Correction Khd = 49.25-7.94=41.31D The “Calculated Khd = 41.31D” is displayed in the IOL Calculation screen:

B. Double K/SRK-T method: This formula has been published by Jaime Aramberri MD. This is not only a method but a specific formula based on the SRK-T formula. The method used to find the correct Post-Op K value is the History Derived method. The original feature of the Double K formula is to use different K values for the 2 parts of the SRK-T formula:

The Kpre for the ELP calculation (Effective Lens Position) The Khd for the IOL power calculation.


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2.2. REFRACTION DERIVED METHOD (Case 2: Only the refractions are known):

Pre-Op & Post-Op Refractions are known: Pre-Op Refraction: -10.00D Post-Op Refraction: -1.00D

Correction at Corneal Plan=Post-Op Refr-Pre-Op Refr = 0.99-(-8.93) = 7.94D We measure the present Keratometry by classical means: K = 44.25D Refraction Derived method: Formula: Krd = 44.25-0.23x7.94 Krd = 44.42D The “Corrected Krd = 44.42D” is displayed in the IOL Calculation screen:


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2.3. ROSA / SHAMMAS (Case 3: Unknown patient history: corrected K value)

We measure the present Keratometry by classical means: Example: K = 44.25D This value is then corrected. 2 regression formulas exist:

A. ROSA Formula: Rr = R(0.0276TL+0.3635)

Where: *TL is the total length *R = 337.5/K KR = 337.5/Rr Example: TL = 25.5mm R = 337.5/44.25 = 7.6271 Rr = 7.6271x(0.7038+0.3635) Rr = 8.14 Then KR = 41.46 The “Corrected KR = 41.46D” is displayed in the IOL Calculation.

NOTE: The Rosa method uses only the SRK formulas.

SRK-T is selected if TL<= 29.4mm SRK-II is selected if TL > 29.4 mm.

B. SHAMMAS Formula: KS = 1.14K-6.8 KS = 1.14x44.25-6.8 KS = 50.45-6.8 KS = 43.65D The “Corrected KS = 43.65D” is displayed in the IOL Calculation screen:

NOTE: The Shammas method uses only the Shammas formula.


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2.4. CONTACT LENS METHOD (Case 4: Unknown patient history: evaluated Post-Op K)

Contact Lens method: We evaluate the Post-Op Keratometry with a Hard Contact Lens in PMMA:

Post-Op Refraction: Post-Op Spectacles Refr = -1.00D Spectacles Refraction with the Contact Lens: CLRefr = +1.00D

The following calculation is done in the IOL Calculation screen: Contact Lens method: Base Curve = BC = 40.00D DRefr = CLRefr-Post-Op Refr DRefr = +1-(-1.00) = +2 Formula: Kcl = BC+DRefr Kcl = 40.00+2 = 42.00D The “Calculated Kcl = 42.00D” is displayed in the IOL Calculation screen.

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