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June 24, 2013

USER MANUAL

I-a I-b II III IV V

Introduction Regulatory & safety information_Europe Regulatory & safety information_USA Technical information Using the COMPACT TOUCH Maintenance Appendix: IOL formulae

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

Chapters:

Directive 93/42/EEC

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

U.S.A.

Quantel Medical 11, rue du bois joli, 63808 Cournon d’Auvergne FRANCE

QUANTEL USA MEDICAL UNIT 601, Haggerty Lane BOZEMAN MT 59715 U.S.A.

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

Tel : +1 888 660 6726 Fax : +1 (406) 586 2924

E-mail : [email protected] Web site: www.quantel-medical.com

E-mail : [email protected] Web site www.quantel-medical.com

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

Manual

User Manual: Introduction

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

June 24, 2013

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

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:

I-a I-b II III IV V

1

Introduction Regulatory & safety information_Europe Regulatory & safety information_USA Technical information Using the COMPACT TOUCH Maintenance Appendix: IOL formulae

24-06-2013

COMPACT TOUCH User Manual: Introduction

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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2

COMPACT TOUCH User Manual: Introduction

3

• • • • •

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)

24-06-2013

User Manual: I-a _ Regulatory and safety information SPECIFIC TO EUROPE

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

June 24, 2013

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

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 • • • • • • • • • • • •

•

1

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.

24-06-2013

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

• • • •

• •

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

2

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

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

wastes

and

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.

3

24-06-2013

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

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 Bprobe 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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4

COMPACT TOUCH User Manual: I-a_Regulatory and safety information SPECIFIC TO EUROPE 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 predisinfection and disinfection of the probe after use. The risky patient (B/) protocol must be used to ensure satisfactory predisinfection - 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 Material

Products

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

5

24-06-2013

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

Agent preparation Disinfectant

Pre-disinfectant:

Soaking trays contents renewing

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.) 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.) 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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6

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

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.



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.

.

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

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

7



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



The probe is ready for use.

24-06-2013

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

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.



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.

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

.

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



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 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 24-06-2013

8

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

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.

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:

9

24-06-2013

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

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10

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

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.

24-06-2013

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

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

June 24, 2013

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

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

1

24-06-2013

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

• • • •

• •

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

2

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

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

wastes

and

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.

3

24-06-2013

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

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 FDAcleared 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 Bprobe 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

4

COMPACT TOUCH User Manual: I-b_Regulatory and safety information SPECIFIC TO USA 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. 1.

2. a. b. c. 3.

To disinfect a probe: 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. Disinfect the probe tip. CDC protocol suggests soaking the probe tip for 5-10 minutes in one of the following solutions: 70% isopropanol alcohol 3% hydrogen peroxide 1:10 dilution of chlorine bleach 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.

5

24-06-2013

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

6

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

7

4.

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

5.

Add gel to the probe tip before starting the examination.

24-06-2013

User Manual: II – Technical information

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

June 24, 2013

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

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 :



1

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COMPACT TOUCH User Manual: II – Technical information

1.2.

On the right panel

  Réf.

Labels & Description Power supply specifications



Probes & footswitch connectors label:



Footswitch Options :

1.3.

Pachymetry probe

A probe

B probe

On the left panel

 

Réf.

Labels & Description



Standby icon

USB / NETWORK connector label



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2 USB connectors (type 2.0)

2

COMPACT TOUCH User Manual: II – Technical information

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 II Protective class Type BF (protection against electrical shocks)

2.2.

Electrical requirements

CAUTION Only connect the power supply module provided by Quantel Medical. Power supply Input voltage Frequency Mains consumption Compact Touch consumption Class Reference Trade Mark

3

External module with automatic voltage adaptation: no selection is needed 100-240 Vac Single phase without earth 47-63 Hz 70 VA 12 Vcc 5A II TR60M12 Cincon Electronics

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COMPACT TOUCH User Manual: II – Technical information

2.3.

Compliance

STANDARD IEC 60 601-1 IEC 60 601-1-1 IEC 60 601-1-2

IEC 60 601-1-6 IEC 60 529 IEC 62 304 ISO 14 971 93/42/EEC

2.4.

SUBJECT Medical electrical equipment-Part 1: General requirements for basic safety and essential performance Medical electrical equipment-Part 1: General requirements for basic safety and essential performance Medical electrical equipment-Part 1: General requirements for basic safety and essential performance – Amendment electromagnetic compatibility – requirements and testing Medical electrical equipment-Part 1-6: General requirements for basic safety and essential performance – Amendment: usability Degree of protection provided by enclosure (IP code) Medical device software – Software life-cycle processus (IEC 62A/474/CDV) Medical devices – Application of risk management to medical devices (ISO/DIS 14971) European Medical Device Directive

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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COMPACT TOUCH User Manual: II – Technical information

2.6.

Echograph specifications

2.6.1. Biometry Probe (option) TP-01-b (Tono-Probe) or TP-02-las (ProBeam) 11 MHz 20 to 25 mm Pulsed 67 Hz 5 mm 20 mm2 0.15 mm (at - 6dB)

Probe Reference Frequency Focal Length Emission running mode Emission Repetition Rate Active diameter Active surface Axial resolution 2.6.2. 10 MHZ B-SCAN Probe (option) Probe Reference Sector angle Frequency Emission-running mode Focal length Active diameter Active surface Axial resolution Lateral resolution

B1 50° 10 MHz Pulsed 24mm to 26mm 7.5mm 44mm² 0.2mm (at -6dB) 0.6mm (at -6dB)

2.6.3. Pachymetry Probe (option) Probe Reference Type Ceramic Frequency Material Emission Repetition Rate

P1 A 20 MHz PZT ceramic 5882 Hz

2.6.4. Acquisition echograms Points in X axis Points in Y axis Electronic resolution

1536 256 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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COMPACT TOUCH User Manual: II – Technical information 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 Minimum (mm)

Maximum (mm)

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

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

Total length at 1532 m/s

14

45

Physiological limits of measurements (auto)

Phakic

Pseudo-phakic

Aphakic

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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COMPACT TOUCH User Manual: II – Technical information 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

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

range

-2 < a0 + 2.53 a1 + 20.00 a2 < 12 -2 < a0+ 3.50 a1 + 27.00 a2 < 12

7

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COMPACT TOUCH User Manual: II – Technical information

2.7.

Materials used

2.7.1. Housing Upper frame Lower frame LCD LED front panel

Polyurethane plastic complying with the UL 94 V0 standard Painted steel sheet Painted steel sheet

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

Pachymetry

B-Scan

2.8.

Body material Face material Manufacturer Body material Face material Manufacturer Body material Face material Manufacturer

Delrin 100 Insulcast I-124 Epoxy Permagile Delrin 100 REXOLITE 1422 Blatek Painted aluminium TPX-MX002 Mitsui

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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COMPACT TOUCH User Manual: II – Technical information 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. 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. The derated peak rarefactional pressure (megapascals) associated with the transmit pattern giving rise to the value reported under MI. The ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, W o is the total time-average power; for the operating condition subject to reporting under ISPPA.3, W 0 is the ultrasonic power associated with the transmit pattern giving rise to the value reported under ISPPA.3. 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. The axial distance at which the reported parameter is measured (centimeters). Are respectively the in-plane (azimuthal) and out-of-plane (elevational) -6dB dimensions in the x-y plane where zsp is found (centimeters). Pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value of the respective parameter. Pulse repetition frequency (Hz) associated with the transmit pattern giving rise to the reported value of the respective parameter. Entrance beam dimensions for the azimuthal and elevational planes (centimeters). Entrance dimensions of the scan for the azimuthal and elevational planes (centimeters).

Ml PR.3 Wo

fc

zSP x-6, y-6 PD PRF EBD EDS

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COMPACT TOUCH User Manual: II – Technical information 2.8.2.1.

A-Scan probe (option)

Probe reference Type Material Frequency

TP-01-b / TP-02-las (ProBeam) A-scan PZT ceramic 11 MHz

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

Associated Acoustic Parameters

ISPTA.3 ISPPA.3 Mechanical index Ultrasonic power Transducer model Operating Mode Application

0.140 mW/cm2 11.611 W/cm2 0.16 0.013 mW TP-01-b / TP-02-las (ProBeam) A-Scan Ophthalmic biometer

Acoustic output

MI

Maximum Value Pr.3 W0 fc Zsp Beam Dimension PD PRF

0.16 0.480

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EBD

(Mpa) (mW) (MHz) (cm) X-6 (cm) Y-6 (cm) (µm) (Hz) Az (cm) E1 (cm)

8.83 2.00

ISPTA.3 (mW/ cm2) 0.140

ISPPA.3 (W/ cm2) 11.611

0.013 8.83 2.00 0.168 0.166

0.013 8.83 2.00 0.168 0.166 0.126 108

0.11 108 0.5 0.5

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COMPACT TOUCH User Manual: II – Technical information 2.8.2.2.

B-Scan probe (option)

Probe reference Type Material Frequency Pulse repetition frequency

B1 B mode Composite material 10 MHz 4655 Hz

Ultrasonic intensities in tissue at measured transducer focus (27mm from probe tip): ISPTA.3 ISPPA.3 Mechanical index Ultrasonic power Transducer model Operating Mode Application

0.22 mW/cm2 24.3 W/cm2 0.196 0.208 mW 10 MHz Ophthalmic Probe B-mode Ophthalmic

Associated Acoustic Parameters

Acoustic output

11

Maximum Value Pr.3 W0 fc Zsp Beam Dimension PD PRF EBD

MI (Mpa) (mW) (MHz) (cm) X-6 (cm) Y-6 (cm) (µs) (Hz) Az (cm) Ele (cm)

0.196 0.56 8.85 2.7

ISPTA.3 (mW/ cm2) 0.22

ISPPA.3 (W/ cm2) 24.3

0.208 8.85

0.208 8.85 2.7 0.094 0.09 0.09 2844

0.09 2844 1.41 0.75

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COMPACT TOUCH User Manual: II – Technical information 2.8.2.3.

Pachymeter probe

Probe reference Type Tip diameter Active tip diameter Focal point Material Ceramic frequency Angle

P1 A 1.2mm 1.5mm 0.5mm from the tip PZT ceramic 20MHz 45 degrees

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

Associated Acoustic Parameters

ISPTA.3 ISPPA.3 Mechanical Index Ultrasonic power Transducer model Operating mode Application

0.097 mW/cm2 0.655 W/cm2 0.04 0.0009 mW Pachymeter A-Scan Ophthalmic Pachymeter

Acoustic output

MI

Maximum Value Pr.3 W0 fc Zsp Beam Dimension PD PRF

0.04 0.15

EBD

(Mpa) (mW) (MHz) (cm) X-6 (cm) Y-6 (cm) (µs) (Hz) Az (cm) E1 (cm)

13.14 0.200

ISPTA.3 (mW/ cm2) 0.097

ISPPA.3 (W/ cm2) 0.655

0.0009 13.14 0.200 0.100 0.104

0.0009 13.14 0.200 0.100 0.104 0.05 2800

0.05 2800 0.12 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.

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COMPACT TOUCH User Manual: II – Technical information 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.

13

Emission test

Compliance

RF emission acc. to EN 55011

Group 1

RF emissions acc. to EN 55011 Harmonic emissions acc. to IEC 61000-3-2

Class A

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

Complies

Class A

Electromagnetic environment Guidance 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. 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.

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COMPACT TOUCH User Manual: II – Technical information

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 Radiated RF disturbances according to IEC 61000-4-3

3 Veff 150 kHz to 80 MHz

10 V

d = 0,35 P d = 0,35 P

3 V/m 80 MHz to 2,5 GHz

10 V/m

d = 0,7 P

for 80 MHz to 800 MHz

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 a electromagnetic site survey , should be less than the compliance level in each b frequency range . 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

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COMPACT TOUCH User Manual: II – Technical information

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. Separation distance according to the transmitter’s frequency (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5GHz Maximum transmitter power output (W) 0,01 0,1 1 10 100

d = 0,35 P

d = 0,35 P

d = 0,7 P

0,035 0,11 0,35 1,1 3,5

0,035 0,11 0,35 1,1 3,5

0,07 0,22 0,70 2,2 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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COMPACT TOUCH User Manual: II – Technical information

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 Electrical fast transients/ burst acc. to IEC 61000-4-4

± 6 kV contact discharge

± 6 kV contact discharge

± 8 kV air discharge ± 2 kV for power supply lines

± 8 kV air discharge ± 2 kV for power supply lines

± 1 kV for input/ output lines

± 1 kV for input/ output lines

Surge acc. to IEC 61000-4-5

± 1 kV differential mode

± 1 kV differential mode

± 2 kV common mode

± 2 kV common mode

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

a0 = 1.277;

a1 = 0.400;

a2 = 0.100;

1.

L = 21.44; AC = 2.69; target refr. Rx= -0.250 > d = 4.497; DL= 26.862

R = 7.45;

2.

L = 23.27; AC = 3.14; IOL implanted DL= 22.000 > d = 4.860; Rx= -0.398

R = 7.69;

3.

L=27.09; AC = 3.48; target refr. Rx = 2.730 > d = 5.378; DL= 5.768

R = 7.76;

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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COMPACT TOUCH User Manual: V – Appendix: IOL formulae

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

Refraction information:

No Historical Data is known

Historical Data is known

Only Pre-op Refraction

Pre-op Keratometry Pre-op Refraction

Refraction with Contact Lens

Current K Measurement KS

Current K Measurement

Khd History derived

Krd Refraction derived

IOL

IOL

All formulae

Double K/SRK-T

IOL All formulae

Available methods & formulae when historical patient data is known.

TL Measurement

SHAMMAS

KR

IOL

ROSA

SHAMMAS

IOL

Kcl Contact Lens

IOL All formulae

SRK-T SRK-II if TL>29.4mm 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.

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COMPACT TOUCH User Manual: V – Appendix: IOL formulae

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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COMPACT TOUCH User Manual: V – Appendix: IOL formulae

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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COMPACT TOUCH User Manual: V – Appendix: IOL formulae

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 29.4 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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COMPACT TOUCH User Manual: V – Appendix: IOL formulae

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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12/06/2012