Quantel Medical Compact Touch Manual

Chapters:
Introduction
I-a Regulatory & safety i nformation_Europe
I-b Regulatory & safety i nformation_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 dAuvergne Cedex
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
E-mail : contact@quantel-medical.fr
Site web: www.quantel-medical.com
2
0
0
8

Directive 93/42/EEC

June 24, 2013

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

Any question regarding the installation or the use of the Compact Touch
system should be directed to the Quantel Medical Service Department or to a
local distributor:

International

Quantel Medical
11, rue du bois joli,
63808 Cournon dAuvergne
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
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 : info@quantelmedical.com
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)
J une 24, 2013

User Manual:
Introduction
June 24, 2013
Quantel Medical
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2
0
0
8

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
III Using the COMPACT TOUCH
IV Maintenance


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 10C (50F): switching on the
instrument may cause serious damage. Unpack the instrument and leave it at
normal temperature for at least half a day to ensure that the internal
components warm up gradually.
5. PACKING LIST
Before beginning the installation, check the contents of the package against
the following list:

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

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


24-06-2013
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)

User Manual:
I-a _ Regulatory and safety information
SPECIFIC TO EUROPE
June 24, 2013
Quantel Medical
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2
0
0
8

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.
SPECIFIC TO EUROPE

24-06-2013
2
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 units hard drive.
Do not connect the unit to the Internet. The Compact Touch does not have
antivirus protection. Connecting the unit to the Internet will cause the warranty
to be void. Quantel Medical is not responsible for any errors caused by
connecting the Compact Touch to the Internet.
The installation of an antivirus may use computer resources that are
necessary to the normal functioning of the Compact Touch unit and thus
reduce the system performances. The image acquisition in real time by the
Compact Touch system might be altered: risk of delays, saccades, image
interruption It is up to the person who would install this type of software to
set the appropriate parameters and validate that the software does not disrupt
the normal functioning of the Compact Touch system (especially concerning
the image acquisition).
SPECIFIC TO EUROPE

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.

SPECIFIC TO EUROPE

24-06-2013
4
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.

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.

SPECIFIC TO EUROPE

24-06-2013
5
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-J acob 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.

Whats needed?
Operators
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. (~36chl)
Products Pre-disinfectant: Sodium hypochlorite at 0,5% a.c
(~1,5chl).
Disinfectant: Sodium hypochlorite at 2% a.c. (~6chl).
NOTE
Measure units: % a.c. =active chlorine percent
chl =Gay-Lussac chlorometric degree.

SPECIFIC TO EUROPE

24-06-2013
6
Agent preparation
Disinfectant 2% a.c. sodium hypochlorite preparation
Pour 1l of warm water (20 to 30C) from the tap into the 5l can.
Pour 4 packs (4x250ml=1l) of concentrated bleach 9,6%ac
(~36chl) 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 20C.)
Pre-disinfectant: 0,5% a.c. sodium hypochlorite
Pour 1l of warm water (20 to 30C) 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 20C.)
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.

SPECIFIC TO EUROPE

24-06-2013
7
A/ Standard protocol
Steps A type of probe B type of probe
Decontamination pre-disinfection
C

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
.
C

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
C

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

Disinfection
C

Immerse the probe
the connector) in a
2% sodium
hypochlorite
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
C

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.

C

The probe is ready for use.

SPECIFIC TO EUROPE

24-06-2013
8
B/ Risky patient protocol
Steps A type of probe B type of probe
Decontamination pre-disinfection
C

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

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
C

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

Inactivation
C

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

Rinsing
C


Disinfection

Immerse the probe
for the connector) in a
2% sodium
hypochlorite

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

Rinsing
SPECIFIC TO EUROPE

24-06-2013
9

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:
C


Drying

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

The probe is ready for use.

SPECIFIC TO EUROPE

24-06-2013
10
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.

SPECIFIC TO EUROPE

24-06-2013
11
3. Roll down the finger cot along the probes 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
June 24, 2013
Quantel Medical
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2
0
0
8

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

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.
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
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.

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 units hard drive.
Do not connect the unit to the Internet. The Compact Touch does not have
antivirus protection. Connecting the unit to the Internet will cause the warranty
to be void. Quantel Medical is not responsible for any errors caused by
connecting the Compact Touch to the Internet.
The installation of an antivirus may use computer resources that are
necessary to the normal functioning of the Compact Touch unit and thus
reduce the system performances. The image acquisition in real time by the
Compact Touch system might be altered: risk of delays, saccades, image
interruption It is up to the person who would install this type of software to
set the appropriate parameters and validate that the software does not disrupt
the normal functioning of the Compact Touch system (especially concerning
the image acquisition).
SPECIFIC TO USA

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.

SPECIFIC TO USA

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.

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.

SPECIFIC TO USA

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
probes tip. Do not completely submerge the probe in cleaning or rinsing
solutions.

How to Disinfect Immersion Scleral Shells
Follow the probe cleaning procedure, ensuring that the immersion shell is fully
submerged in the disinfectant solution. Tubing for biometry shell is intended
for single use.
Shells must not be disinfected using procedures that use heat (autoclave) or
gas.
2.3.2. 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.

SPECIFIC TO USA

24-06-2013
6
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 probes body.

SPECIFIC TO USA

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:
June 24, 2013
Quantel Medical
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2
0
0
8

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-probe10 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

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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

Rf. Labels & Description

Power suppl y specifications

Probes & footswitch connectors label:

Options : Pachymetry
probe
A
probe
B
probe

1.3. On the left panel

Rf. Labels & Description

Standby icon

USB / NETWORK connector label

2 USB connectors (type 2.0)

Footswitch

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1.4. Footswitch

Rf. Label

IP44 (According to IEC 60529):
- Protection against the penetration of foreign solid bodies of diameter 1 mm.
- Protection against splashing water.

Electrical/electronic equipment in accordance with the Directive 2012 /19 / 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
basic safety and essential performance
IEC 60 601-1-2
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 (50F < T < 95F)

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 (- 4F < T < 158F)

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
Acti ve diameter 5 mm
Acti ve surface 20 mm
2

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
Acti ve diameter 7.5mm
Acti ve surface 44mm
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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6
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
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:
I
t
= I
w
exp(-0.069fz)

Where:
I
t
=is the estimated in situ intensity
I
w
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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9
2.8.2. Sonic values
Transducer parameters show considerable variation from transducer to
transducer. The measured and calculated values given in the sections below
(2.8.2.1 / 2.8.2.2 / 2.8.2.3) were those for 3 actual transducers, whose values
deviated slightly from the values in the specification above, and whose values
are likely to be different from the transducer of the users system. However,
the values in the specification should give results that are accurate enough for
any practical purpose, since the intensities are very low.

CAUTION:
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:
I
SPTA.3

The derated spatial-peak temporal-average intensity (milliwatts per square
centimeter).
I
SPPA.3
The derated spatial-peak pulse-average intensity (watts per square centimeter).
The value of I
PA.3
at the position of global maximum MI (I
PA.3
@MI) may be
reported instead of I
SPPA.3
if the global maximum MI is reported.
Ml The Mechanical Index. The value of MI at the position of I
SPPA 3
, (MI@I
SPPA.3
)
may be reported instead of MI (global maximum value) if I
SPPA.3
is <190W/cm
2
.
P
R.3
The derated peak rarefactional pressure (megapascals) associated with the
transmit pattern giving rise to the value reported under MI.
W
o
The ultrasonic power (milliwatts). For the operating condition giving rise to
I
SPTA.3
, W
o
is the total time-average power; for the operating condition subject
to reporting under I
SPPA.3
, W
0
is the ultrasonic power associated with the
transmit pattern giving rise to the value reported under I
SPPA.3
.
f
c
The center frequency (MHz). For Ml and I
SPPA.3
, f
c
is the center frequency
associated with the transmit pattern giving rise to the global maximum value of
the respective parameter. For I
SPTA.3
, for combined modes involving beam
types of unequal center frequency, f
c
is defined as the overall range of center
frequencies of the respective transmit patterns.
z
SP
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 z
sp
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
Frequency 11 MHz

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

I
SPTA.3
0.140 mW/cm
2

I
SPPA.3
11.611 W/cm
2

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
I
SPTA.3

(mW/ cm
2
)
I
SPPA.3

(W/ cm
2
)
Maximum Value 0.16 0.140 11.611
A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

P
a
r
a
m
e
t
e
r
s

P
r.3
(Mpa) 0.480
W
0
(mW) 0.013 0.013
f
c
(MHz) 8.83 8.83 8.83
Z
sp
(cm) 2.00 2.00 2.00
Beam
Dimension
X
-6
(cm) 0.168 0.168
Y
-6
(cm) 0.166 0.166
PD (m) 0.11 0.126
PRF (Hz) 108 108
EBD
Az (cm) 0.5
E1 (cm) 0.5


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2.8.2.2. B-Scan probe (option)
Probe 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):

I
SPTA.3
0.22 mW/cm
2

I
SPPA.3
24.3 W/cm
2

Mechanical index 0.196
Transducer model 10 MHz Ophthalmic Probe
Operating Mode B-mode
Application Ophthalmic

Acoustic output MI
I
SPTA.3

(mW/ cm
2
)
I
SPPA.3

(W/ cm
2
)
Maximum Value 0.196 0.22 24.3
A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

P
a
r
a
m
e
t
e
r
s

P
r.3
(Mpa) 0.56
W
0
(mW) 0.208 0.208
f
c
(MHz) 8.85 8.85 8.85
Z
sp
(cm) 2.7 2.7
Beam
Dimension
X
-6
(cm) 0.094
Y
-6
(cm) 0.09
PD (s) 0.09 0.09
PRF (Hz) 2844 2844
EBD
Az (cm) 1.41
Ele (cm) 0.75


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12
2.8.2.3. Pachymeter probe

Probe reference P1
Type A
Tip diameter 1.2mm
Acti ve tip diameter 1.5mm
Focal point 0.5mm from the tip
Ceramic frequency 20MHz
Angle 45 degrees

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

I
SPTA.3
0.097 mW/cm
2

I
SPPA.3
0.655 W/cm
2

Mechanical Index 0.04
Transducer model Pachymeter
Operating mode A-Scan
Application Ophthalmic Pachymeter

Acoustic output MI
I
SPTA.3

(mW/ cm
2
)
I
SPPA.3

(W/ cm
2
)
Maximum Value 0.04 0.097 0.655
A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

P
a
r
a
m
e
t
e
r
s

P
r.3
(Mpa) 0.15
W
0
(mW) 0.0009 0.0009
f
c
(MHz) 13.14 13.14 13.14
Z
sp
(cm) 0.200 0.200 0.200
Beam
Dimension
X
-6
(cm) 0.100 0.100
Y
-6
(cm) 0.104 0.104
PD (s) 0.05 0.05
PRF (Hz) 2800 2800
EBD
Az (cm) 0.12
E1 (cm) 0.12

Accuracy in pachymetry 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 appl ying 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 manufacturers 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


24-06-2013
14

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 l evel
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

P d 35 , 0 =

Radiated RF
disturbances
according to IEC
61000-4-3

3 V/m
80 MHz to 2,5 GHz

10 V/m
P d 35 , 0 = for 80 MHz to 800 MHz
P d 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 survey
a
, should be
less than the compliance level in each
frequency range
b
.

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 appl y 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
theoreticall y 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 transmitters frequency (m)
150 kHz to 80 MHz

P d 35 , 0 =

80 MHz to 800 MHz

P d 35 , 0 =

800 MHz to 2,5GHz

P d 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 appl y in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

24-06-2013
16

Guidance and manufacturer declaration electromagnetic immunity
The Compact Touch is intended for use in the el ectromagnetic 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 l evel 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
correspond with one characteristic for a
environment.
Voltage dips,
short-term
interruptions and
voltage
variations on
power suppl y
input lines acc.
to 61000-4-11
<5% during 0,5 period

40% during 5 periods


<5% during 5 s

<5% during 0,5 period



<5% during 5 s
correspond to one characteristic for a
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

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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 suppl y
12Vdc
Pachymetry probe
Biometry probe:
TP-01b/TP-02-las
B Probe
Footswitch

24-06-2013
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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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19
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

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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

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5.2. Patient exam area
The patient exam area is diposed as follows:

5.3. Power supply
The power supply is an external module with an automatic voltage adaptation.
It includes a 2.5mm power supply connector. For more information, refer to
the:

Compact 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 suppl y

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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

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

5.5.2. Pachymetry Probe
The pachymetry connector is located on the right
panel. The pachymetry probe must be plugged into
this BNC connector

A specific probe holder is located on the left hand side of front
panel (see figure)

5.5.3. B-probe10 MHz
The B-probe connector is located on the right panel.
The red dot connector of the probe connector must
correspond to the red dot connector of the Compact
Touch connector.

The A probe holder is located on the right side of the
Compact Touch (see figure).
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
June 24, 2013
Quantel Medical
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2
0
0
8

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

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
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 onl y i f the option has been validated.
Section 6-2 : B-scan

Open the Pachymetry screens.
This button is present onl y i f 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 / Franais / Espaol / 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 units 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
Acti vate 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:
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)
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
(m)
Correction
(mmHg)
Pachymetry (m)
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
Pachymetry (m)
Correction
(mmHg)
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.

Pachymetry (m)
Correction
(mmHg)
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
Appl y 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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17

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

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 patients
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 operators 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 probes 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)

To carry out this examination, the patient has to be lied down. The easiest
location for the examiner is to be behind the patients 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 gui ded 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)
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

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 previousl y added to the
report.
Clear report
Allows the user to unselect all images that were
previousl y 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)
Long pressure
(more than 1s)
Short pressure
(less than 1s)
Long pressure
(more 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).
Move the mouse to set the new marker 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).
Move the mouse to set the new area point 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

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 Onl y, 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: .

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
calcul ation was performed from a
specific axi al l ength measurement
selected from the results table, the
curve and IOL calcul ations will then
correspond to this selected line.

2: This line corresponds to the
result chosen by the user in the IOL
calcul ation page. It can ei ther
correspond to:

- The average
- The chosen line that has been
selected in the result tabl e by the
user
- The (TL and AC) values which
can be modifi ed 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:
.
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: .

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
previousl y added to the report are unselected.

24-06-2013
49

User Manual:
IV - Maintenance
June 12, 2012
Quantel Medical
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2
0
0
8

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 probes 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.

12-06-2012
2
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 probes 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

12-06-2012
3
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

12-06-2012
4
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:
June 12, 2012
Quantel Medical
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2
0
0
8

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 J AIME 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


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 AL)

Kd =337.5 / Rmm
Rmm =337.5 / Kd

C1 =-5.40948 +0.58412 x Lc +0.098 x Kd

Rc =[Rmm - (C1) / 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. Doubl e 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 AL)

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 =[Rpre - (CW) / 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)]


12/06/2012
4
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)


12/06/2012
5
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 (Rag - AG /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)


12/06/2012
6
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]
]

Rx =R / (1 +0.012R)


12/06/2012
7
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

1.0125
K

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

1.0125
K + 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


12/06/2012
8
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 n
L - 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)]

12/06/2012
9
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 a
0
, a
1
and a
2
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 a
0
, a
1
and a
2
.

Global limitations: 1.16 <a
0
+3.37a
1
+23.39a
2
<7
1.16 <a
0
+2.53a
1
+20.00a
2
<7
1.16 <a
0
+3.50a
1
+27.00a
2
<7


12/06/2012
10
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. R
x
=-0.250
>d =4.497; D
L
=26.862

2. L =23.27; AC =3.14; R =7.69;
IOL implanted D
L
=22.000
>d =4.860; R
x
=-0.398

3. L=27.09; AC =3.48; R =7.76;
target refr. R
x
=2.730
>d =5.378; D
L
=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.
Wrzburg, J an.25th , 2000; Dr.W.Haigis


12/06/2012
11
2. IOL calculation for Post Refracti ve 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

12/06/2012
12
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 deri ved 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 J aime 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.


12/06/2012
13
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:


12/06/2012
14
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.

12/06/2012
15
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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Quantel Medical Compact Touch Manual

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