Manual User Compact Touch XE CTT ME An 140905

COMPACT TOUCH USER MANUAL
Select a chapter:
Introduction
I Regulatory & safety information
II Technical information
III Using the COMPACT TOUCH
IV Maintenance
V Appendix: IOL formulae
11, rue du bois joli - CS 40015
63808 Cournon dAuvergne Cedex
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
E-mail : contact@quantel-medical.fr
Site web: www.quantel-medical.com
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Directive 93/42/EEC

SEPTEMBER 2014

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

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

International

QUANTEL MEDICAL
11, rue du bois joli,
63808 Cournon dAuvergne
FRANCE

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

2014 QUANTEL MEDICAL
All rights reserved
COMPACT TOUCH User Manual
Software Version 3.02
International version
(Ref: XE_CTT_ME_AN)
September 5, 2014

User Manual
Introduction
SEPTEMBER 2014
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
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Directive 93/42/EEC

CONTENTS REV*
1. INTRODUCTION............................................................................................................................................................. 1
2. USER MANUAL DESCRIPTION .................................................................................................................................. 1
3. USER MANUAL TERMS AND SAFETY SYMBOLS .................................................................................................. 1
4. UNPACKING THE INSTRUMENT ............................................................................................................................... 2
5. PACKING LIST ............................................................................................................................................................... 2

User manual:
Introduction

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

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

* Some of those options require an activation keycode. Please contact QUANTEL MEDICAL or your local
distributor for details on how to order those packages and get the activation keycodes.

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

Setup of the COMPACT TOUCH is simple. Built on a PC board, the software is ready to use.

The device can be delivered with the following configurations:

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

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

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

Introduction
I Regulatory & safety information
IV Maintenance

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.

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Introduction

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Intro /2
4. UNPACKING THE INSTRUMENT
The instrument is delivered in a special shockproof casing. If the instrument has been subjected to low
temperature during transportation, it should not be turned on immediately after unpacking.

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

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

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

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

COMPACT TOUCH B (XECTTB):
Basic configuration
B1 probe (10MHz) with carrying case
B1 and biometry probe holder
Footswitch
Mouse

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

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

User Manual:
I - Regulatory & safety information
SEPTEMBER 2014
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
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Directive 93/42/EEC

CONTENTS REV*
1. INTENDED USE AND CONTRAINDICATIONS ................................................................................................... 1
2. SAFETY INFORMATION AND PRECAUTIONS ................................................................................................ 1*
2.1. General warnings and cautions information................................................................................................... 1*
2.2. Probes care / WARNINGS and CAUTIONS ..................................................................................................... 2*
2.3. How to prevent a transfer of infection ............................................................................................................. 3*
2.3.1. Pre-disinfection and disinfection procedures / Europe .................................................................. 3*
2.3.2. Pre-disinfection and disinfection procedures / USA only .............................................................. 3*
2.3.3. Finger cots ................................................................................................................................................. 3*
2.4. Precautions to take concerning wastes and elimination of device and accessories ........................... 4*

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I Regulatory & safety
information

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

Visualization of the interior of the eye and the orbit by A and B scans.
Axial Length measurement of the eye by ultrasonic means.
Implanted IOL power calculation, using the Axial Length measurement.
Measurement of corneal thickness by ultrasonic means.
2. SAFETY INFORMATION AND PRECAUTIONS
2.1. General warnings and cautions information
Tissue exposure to ultrasound energy: The COMPACT TOUCH unit is designed for use in ophthalmology
only. While QUANTEL MEDICAL is not aware of any reports of adverse effects from using
ophthalmologic ultrasound biometry, no other use is intended or implied. The system controls limit the
output energy to within the parameters specified for its intended purpose. No control of ultrasound
energy is available to the user other than the duration of exposure.

WARNINGS
This device is required to be sold only by on the prescription of a physician.
This device is not intended for foetal use.
Disconnect AC power before cleaning the case.
AC power should be disconnected every time after turning the system OFF
To avoid risk of electric shock, this equipment must only be connected to supply mains with protective
earth.
While using the unit, mains plug must be easily accessible.
The COMPACT TOUCH IOL calculator will calculate negative IOL values if such is predicted by the
entered data. These are displayed with a minus sign (-). Do not ignore this sign!
Be careful not to compress the cornea when measuring axial length.
No modification of this equipment is allowed.
Before adding any other equipment to the basic configuration, please refer to the:
COMPACT TOUCH User Manual: Chapter II - Technical information
Section 5.4 Connections to the right and left panels
Do not modify the equipment without authorization of the manufacturer.
In case the equipment is modified, appropriate inspection and testing must be conducted to ensure
continued safe use of the equipment.
Only connect Medical Electrical Equipment which has been specified as some parts of the equipment or
as compatible with the equipment.
The COMPACT TOUCH has to be disconnected from the telecom, IT network and/or USB accessories
during examination.
Only use a network device or USB accessories that comply with IEC 60601-1 and IEC 60950 standards.
When new equipment (not delivered by QUANTEL MEDICAL) is connected to the equipment (via USB,
network...), the leakage current measurements and checks have to be performed by the responsible
organization with the new equipment installation: clause 16 IEC 60601-1 third edition.

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

CAUTIONS
Considering the current concern for possible unknown hazards, and despite the extremely low output
intensities used in ultrasound biometry, QUANTEL MEDICAL recommends that patient exposure time
during measurement be minimized.
To preserve the finish of the case, avoid the use of abrasive cleaners. If possible, clean spots before
they dry.
Do not install non QUANTEL MEDICAL software onto the unit, as it may compromise the COMPACT
TOUCH software. Installing non QUANTEL MEDICAL software will cause the warranty to be void.
QUANTEL MEDICAL is not responsible for any errors caused by additional programs on the units hard
drive.
Do not connect the unit to the Internet. The COMPACT TOUCH does not have antivirus protection.
Connecting the unit to the Internet will cause the warranty to be void. QUANTEL MEDICAL is not
responsible for any errors caused by connecting the COMPACT TOUCH to the Internet.
The installation of an antivirus may use computer resources that are necessary to the normal
functioning of the COMPACT TOUCH unit and thus reduce the system performances. The image
acquisition in real time by the COMPACT TOUCH system might be altered: risk of delays, saccades,
image interruption It is up to the person who would install this type of software to set the appropriate
parameters and validate that the software does not disrupt the normal functioning of the COMPACT
TOUCH system (especially concerning the image acquisition).
2.2. Probes care / WARNINGS and CAUTIONS

WARNINGS
If you notice a change in the probe efficiency or have any doubt about the probe integrity: contact
QUANTEL MEDICAL Service Department or your local distributor.

CAUTIONS
The probes are fragile and must be handled with care. They will be damaged if dropped onto a hard
surface.
The probes should never be autoclaved or subjected to excessive heat.
Do not use any abrasive cleaning products or solvents that may alter the probes body aspect. If
possible, clean off stains immediately.
The B-probe must not be totally immersed. : for disinfection purposes, only the tip of the probe should be
placed in liquid. Maximum immersion depth for B-probe is 5 cm. The A-scan probe can be immersed.
After cleaning; rinse the end of the probe thoroughly with clean water to remove all traces of liquid used.
The surfaces should then be dried with a lint-free cloth.
The ultrasound unit must be imperatively turned off before disconnecting the probes. Avoid splashing
liquids onto the probe connectors.
Do not immerse the connector.

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2.3. How to prevent a transfer of infection
2.3.1. Pre-disinfection and disinfection procedures / Europe
WARNINGS
Between two patients, the probes and scleral shells must be cleaned to prevent patient-to-patient
transfer of infection. QUANTEL MEDICAL recommends cleaning procedures:
QUANTEL MEDICAL devices pre-disinfection and disinfection procedures.
(Documentation code XE_SDE_PR_AN)
Probes & scleral shells must be disinfected prior to first use.
2.3.2. Pre-disinfection and disinfection procedures / USA only
Probes must be disinfected for each patient to prevent the transmission of infection. Follow the Centers
for Disease Control and Prevention (CDC) or institutional protocols for equipment sterilization.
Probes must also be disinfected prior to first use.

To disinfect a probe:
1. Clean the probe clean with a cloth. Ensure that all coupling medium and fluids are removed. The probe
tip may be wiped with an alcohol swab prior to soaking.
2. Disinfect the probe tip. CDC protocol suggests soaking the probe tip for 5-10 minutes in one of the
following solutions:
a. 70% isopropanol alcohol
b. 3% hydrogen peroxide
c. 1:10 dilution of chlorine bleach
3. Rinse the probe tip thoroughly in fresh water and allow to air dry.
Probes must not be heated (autoclave) or gas sterilized. Only clean the probes tip. Do not completely
submerge the probe in cleaning or rinsing solutions.

How to Disinfect Immersion Scleral Shells
Follow the probe cleaning procedure, ensuring that the immersion shell is fully submerged in the
disinfectant solution. Tubing for biometry shell is intended for single use.
Shells must not be disinfected using procedures that use heat (autoclave) or gas.
2.3.3. Finger cots
Finger cots are a simple way of preventing probe contamination:
WARNING
The finger cots are for a single use only and must be replaced after each patient.

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

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

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

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

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

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

2.4. Precautions to take concerning wastes and elimination of device and
accessories
This product complies with the WEEE Directive (2012/19/EU) marking requirements. The COMPACT
TOUCH is an electrical / electronic product and must not be discarded with domestic household waste

Do not dispose with domestic household
wastes!

Product category:

With reference to the equipment types in the WEEE Directive annex I, this product is classed as
category 8 among the "Medical devices (with the exception of all implanted and infected products)".

To dispose completely of the device and its accessories, contact QUANTEL MEDICAL.

User Manual:
SEPTEMBER 2014
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
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Directive 93/42/EEC Directive 93/42/EEC Directive 93/42/EEC Directive 93/42/EEC

CONTENTS CONTENTS CONTENTS CONTENTS REV* REV* REV* REV*
1. LABELS ................................................................................................................................................................................. 1*
1.1. On the back panel ................................................................................................................................................. 1*
1.2. On the right panel .................................................................................................................................................... 2
1.3. On the left panel ...................................................................................................................................................... 2
1.4. Footswitch .............................................................................................................................................................. 3*
2. TECHNICAL SPECIFICATIONS ........................................................................................................................................... 3
2.1. Classification ............................................................................................................................................................ 3
2.2. Electrical requirements ......................................................................................................................................... 3
2.3. Compliance ............................................................................................................................................................... 4
2.4. Dimensions ............................................................................................................................................................... 4
2.5. Environmental conditions ...................................................................................................................................... 4
2.6. Echograph specifications ..................................................................................................................................... 4
2.6.1. Biometry Probe (option) ..................................................................................................................... 4
2.6.2. 10 MHz B-SCAN Probe (option) ....................................................................................................... 5
2.6.3. Pachymetry Probe (option) ............................................................................................................... 5
2.6.4. Acquisition echograms ...................................................................................................................... 5
2.6.5. Measurements accuracy .................................................................................................................. 5
2.6.6. Accuracy in IOL calculation .............................................................................................................. 5
2.6.7. Physiological limits of measurements ............................................................................................ 6
2.6.8. Data entry limits ................................................................................................................................... 7
2.7. Materials used ......................................................................................................................................................... 8
2.7.1. Housing .................................................................................................................................................. 8
2.7.2. Probes (Housing and material in contact with the patient) ....................................................... 8
2.8. Tissue Exposure to Ultrasound Energy .............................................................................................................. 8
2.8.1. ALARA section (ALARA: as low as reasonably possible) ........................................................... 8
2.8.2. Sonic values ......................................................................................................................................... 9

3. COMPACT TOUCH: EMC DATA AND GUIDELINES ..................................................................................................... 13
4. UNIT DESCRIPTION & INSTALLATION ......................................................................................................................... 17
4.1. Right Panel ............................................................................................................................................................. 17
4.2. Left Panel 18
4.3. Front Panel ............................................................................................................................................................. 19
5. Installation: technical information..................................................................................................................... 20
5.1. Probe holder assembling .................................................................................................................................... 20
5.2. Patient exam area ................................................................................................................................................. 21
5.3. Power supply ......................................................................................................................................................... 21
5.4. Connections to the right and left panels .......................................................................................................... 22
5.5. Probe connections................................................................................................................................................ 24
5.5.1. Biometry probe .................................................................................................................................. 24
5.5.2. Pachymetry Probe ............................................................................................................................. 25
5.5.3. B-probe10 MHz ................................................................................................................................ 25
5.5.4. Footswitch .......................................................................................................................................... 25
5.5.5. USB Ports ............................................................................................................................................ 26
5.5.6. Network port ...................................................................................................................................... 26
5.5.7. Handle .................................................................................................................................................. 26

User manual User manual User manual User manual
II II II II Technical information Technical information Technical information Technical information

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1. 1. 1. 1. LABELS LABELS LABELS LABELS
1.1. On the back panel

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

Re Re Re Ref. f. f. f. Labels & Labels & Labels & Labels & Description Description Description Description

Identification label Identification label Identification label Identification label

Protection against electrical shocks: the applied parts are classified as
BF Type".
IEC 60417 IEC 60417 IEC 60417 IEC 60417- -- -5 55 5333 333 333 333

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

Refer to the instruction manual/ booklet
ISO 7010 ISO 7010 ISO 7010 ISO 7010- -- -M002 M002 M002 M002

For indoor use only.
I II IEC 60417 EC 60417 EC 60417 EC 60417- -- -5957 5957 5957 5957

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

General warning sign
ISO 7010 ISO 7010 ISO 7010 ISO 7010- -- -W001 General W001 General W001 General W001 General

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

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


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1.2. On the right panel

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

Power supply specifications Power supply specifications Power supply specifications Power supply specifications

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

Options Options Options Options : :: : Pachymetry Pachymetry Pachymetry Pachymetry
probe probe probe probe
A probe A probe A probe A probe B BB B
probe probe probe probe

1.3. On the left panel

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

Standby Standby Standby Standby icon icon icon icon

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

2 USB connectors (type 2.0)

Footswitch


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1.4. Footswitch

Rf. Rf. Rf. Rf. Label Label Label Label

IP44 IP44 IP44 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 / EU (WEEE)
Do not dispose with domestic household wastes.
EN 50419 EN 50419 EN 50419 EN 50419
2. 2. 2. 2. TECHNICAL SPECIFICATIONS TECHNICAL SPECIFICATIONS TECHNICAL SPECIFICATIONS TECHNICAL SPECIFICATIONS
2.1. Classification
The system is intended for continuous operation and has the following classification:
Electric security class Electric security class Electric security class Electric security class EN 60 601-1 Standard
Protective class Protective class Protective class Protective class II
Type Type Type Type BF (protection against electrical shocks)
2.2. Electrical requirements
CAUTION CAUTION CAUTION CAUTION
Only connect the power supply module provided by QUANTEL MEDICAL.

Power supply Power supply Power supply Power supply
External module with automatic voltage adaptation: no
selection is needed
Input voltage Input voltage Input voltage Input voltage
100-240 Vac
Single phase without earth
Frequency Frequency Frequency Frequency
47-63 Hz
Mains consumption Mains consumption Mains consumption Mains consumption
70 VA
COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH consumption consumption consumption consumption
12 Vcc 5A
Class Class Class Class
II
Reference Reference Reference Reference
TR60M12
Trade Mark Trade Mark Trade Mark Trade Mark
Cincon Electronics


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2.3. Compliance
STANDARD STANDARD STANDARD STANDARD SUBJECT SUBJECT SUBJECT SUBJECT
IEC 60 601 IEC 60 601 IEC 60 601 IEC 60 601- -- -1 11 1
Medical electrical equipment-Part 1: General requirements for basic safety and
essential performance
IEC 60 601 IEC 60 601 IEC 60 601 IEC 60 601- -- -1 11 1- -- -1 11 1
essential performance
IEC 60 601 IEC 60 601 IEC 60 601 IEC 60 601- -- -1 11 1- -- -2 22 2
essential performance Amendment electromagnetic compatibility requirements
and testing
IEC 60 601 IEC 60 601 IEC 60 601 IEC 60 601- -- -1 11 1- -- -6 66 6
Medical electrical equipment-Part 1-6: General requirements for basic safety and
essential performance Amendment: usability
IEC 60 529 IEC 60 529 IEC 60 529 IEC 60 529 Degree of protection provided by enclosure (IP code)
IEC 62 304 IEC 62 304 IEC 62 304 IEC 62 304 Medical device software Software life-cycle processus (IEC 62A/474/CDV)
ISO 14 971 ISO 14 971 ISO 14 971 ISO 14 971
Medical devices Application of risk management to medical devices (ISO/DIS
14971)
93/42/EEC 93/42/EEC 93/42/EEC 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 < 10 C < 10 C < 10 C < T < 35 C T < 35 C T < 35 C T < 35 C (50F < T < 95F) (50F < T < 95F) (50F < T < 95F) (50F < T < 95F)

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

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

Maximum operating altitude: 2000m (about 7000 ft)
2.6. Echograph specifications
2.6.1. Biometry Probe (option)
Probe Reference Probe Reference Probe Reference Probe Reference
TP-01-b (Tono-Probe)
or TP-02-las (ProBeam)
Frequency Frequency Frequency Frequency 11 MHz
Focal Length Focal Length Focal Length Focal Length 20 to 25 mm
Emission running mode Emission running mode Emission running mode Emission running mode Pulsed
Emission Repetition Emission Repetition Emission Repetition Emission Repetition Rate Rate Rate Rate 67 Hz
Active diameter Active diameter Active diameter Active diameter 5 mm
Active surface Active surface Active surface Active surface
20 mm
2

Axial resolution Axial resolution Axial resolution Axial resolution 0.15 mm (at - 6dB)


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2.6.2. 10 MHZ B-SCAN Probe (option)
Probe Reference Probe Reference Probe Reference Probe Reference B1
Sector angle Sector angle Sector angle Sector angle 50
Emission Emission Emission Emission- -- -running mode running mode running mode running mode Pulsed
Focal length Focal length Focal length Focal length 24mm to 26mm
Active diameter Active diameter Active diameter Active diameter 7.5mm
Active surface Active surface Active surface Active surface 44mm
Axial resolution Axial resolution Axial resolution Axial resolution 0.2mm (at -6dB)
Lateral resolution Lateral resolution Lateral resolution Lateral resolution 0.6mm (at -6dB)
2.6.3. Pachymetry Probe (option)
Probe Reference Probe Reference Probe Reference Probe Reference P1
Type Type Type Type A
Ceramic Frequency Ceramic Frequency Ceramic Frequency Ceramic Frequency 20 MHz
Material Material Material Material PZT ceramic
Emission Repetition Rate Emission Repetition Rate Emission Repetition Rate Emission Repetition Rate 5882 Hz
2.6.4. Acquisition echograms
Points in X axis Points in X axis Points in X axis Points in X axis 1536
Points in Y axis Points in Y axis Points in Y axis Points in Y axis 256
Electronic resolution Electronic resolution Electronic resolution Electronic resolution 0.03mm at 1550m/s
2.6.5. Measurements accuracy
The accuracy is achieved by the electronic resolution: 0.03 mm
The global accuracy of the A-Scan is dependent upon:
A good alignment with the visual axis
A low pressure on cornea, especially when using the Contact Technique

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


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2.6.7. Physiological limits of measurements

Physiological limits of Physiological limits of Physiological limits of Physiological limits of measurement measurement measurement measurements (auto) s (auto) s (auto) s (auto) Minimum (mm) Minimum (mm) Minimum (mm) Minimum (mm)
Maximum Maximum Maximum Maximum
(mm) (mm) (mm) (mm)
Phakic Phakic Phakic Phakic
Anterior chamber at: Anterior chamber at: Anterior chamber at: Anterior chamber at:
1532 1532 1532 1532 m/s m/s m/s m/s
1.5 7
Lens thickness at 1641 m/s Lens thickness at 1641 m/s Lens thickness at 1641 m/s Lens thickness at 1641 m/s 2.5 7
Total length = AC+L+V Total length = AC+L+V Total length = AC+L+V Total length = AC+L+V 14 45
Pseudo Pseudo Pseudo Pseudo- -- -phakic phakic phakic phakic
Anterior chamber at Anterior chamber at Anterior chamber at Anterior chamber at: :: :
1532 1532 1532 1532 m/s m/s m/s m/s
1.5 7
Lens thickness at 1641 m/s Lens thickness at 1641 m/s Lens thickness at 1641 m/s Lens thickness at 1641 m/s 0.5 7
Total length Total length Total length Total length = AC+ = AC+ = AC+ = AC+L LL L+V +V +V +V 14 45
Aphakic Aphakic Aphakic Aphakic Total length at 1532 m/s Total length at 1532 m/s Total length at 1532 m/s Total length at 1532 m/s 14 45

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

Parameters Parameters Parameters Parameters Allowable range Allowable range Allowable range Allowable range
Minimum Maximum
Anterior chamber, lens and vitreous velocities Anterior chamber, lens and vitreous velocities Anterior chamber, lens and vitreous velocities Anterior chamber, lens and vitreous velocities 500 m/s 5000 m/s
Dense cataract velocity Dense cataract velocity Dense cataract velocity Dense cataract velocity 500 m/s 5000 m/s
PMMA, acrylic and silicon IOL velocity PMMA, acrylic and silicon IOL velocity PMMA, acrylic and silicon IOL velocity PMMA, acrylic and silicon IOL velocity 500 m/s 5000 m/s
Keratometry in millimeters Keratometry in millimeters Keratometry in millimeters Keratometry in millimeters 5 mm 13 mm
Keratometry in diopter Keratometry in diopter Keratometry in diopter Keratometry in diopter 25.0 D 68.0 D
Total Total Total Total length in IOL calculation screen length in IOL calculation screen length in IOL calculation screen length in IOL calculation screen 15 mm 40 mm
Anterior chamber in IOL calculation screen Anterior chamber in IOL calculation screen Anterior chamber in IOL calculation screen Anterior chamber in IOL calculation screen 0 mm 9.9 mm
Post Post Post Post- -- -operative ametropia operative ametropia operative ametropia operative ametropia -20.0 D +20.0 D
SRK A constant SRK A constant SRK A constant SRK A constant 113.00 120.59
Holladay surgeon factor calculated from A Holladay surgeon factor calculated from A Holladay surgeon factor calculated from A Holladay surgeon factor calculated from A -1.61 +2.69
Hoffer Hoffer Hoffer Hoffer- -- -Q ACD Q ACD Q ACD Q ACD 2.05 6.48
Binkhorst II post Binkhorst II post Binkhorst II post Binkhorst II post- -- -op. anterior chamber depth: ACDb op. anterior chamber depth: ACDb op. anterior chamber depth: ACDb op. anterior chamber depth: ACDb 1 mm 8 mm
Constant for Haigis formula: a Constant for Haigis formula: a Constant for Haigis formula: a Constant for Haigis formula: a0 00 0 -10 +10
Constant for Haigis formula: a Constant for Haigis formula: a Constant for Haigis formula: a Constant for Haigis formula: a1, 1, 1, 1, a aa a2 22 2 -1 +1
Haigis constants: combined limits for a (1.16 to 7mm) Haigis constants: combined limits for a (1.16 to 7mm) Haigis constants: combined limits for a (1.16 to 7mm) Haigis constants: combined limits for a (1.16 to 7mm)
ACD range ACD range ACD range 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


XE_CTT_ME_AN_140905

II /8
2.7. Materials used
2.7.1. Housing
Upper frame Upper frame Upper frame Upper frame Polyurethane plastic complying with the UL 94 V0 standard
Lower frame Lower frame Lower frame Lower frame Painted steel sheet
LCD LCD LCD LCD LED LED LED LED front panel front panel front panel front panel Painted steel sheet
2.7.2. Probes (Housing and material in contact with the patient)
A AA A- -- -Scan Scan Scan Scan Body material Delrin 100
Face material Insulcast I-124 Epoxy
Manufacturer Permagile
Pachymetry Pachymetry Pachymetry Pachymetry Body material Delrin 100
Face material REXOLITE 1422
Manufacturer Blatek
B BB B- -- -Scan Scan Scan 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 WARNING WARNING WARNING
This device is not intended for foetal use.
2.8.1. ALARA section (ALARA: as low as reasonably possible)
Ultrasound energy will always be attenuated by the tissue between the transducer and the focus when
used as recommended. The values presented here are the values at the focal point, the point of
maximum intensity.

It is not possible to vary the output energy of the transducer. However, to minimize exposure,
measurements should be kept as short as possible.

If more accuracy is desired, the intensity in the body at any transducer point may be calculated
according to the formula recommended by the FDA:

I II I
t t t t
= I = I = I = I
w ww w
exp( exp( exp( exp(- -- -0.069fz) 0.069fz) 0.069fz) 0.069fz)

Where:
I II I
t tt t
= is the estimated in situ intensity
I II I
w ww w
is the measured intensity in water at the focus of the transducer
f ff f is the ultrasonic frequency in megahertz
z zz 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.


XE_CTT_ME_AN_140905

II /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: CAUTION: CAUTION: CAUTION:
It is always recommended to minimize exposure by limiting the ultrasonic transmission to as short
periods as possible.

Symbols used in the following tables are described below:
I II I
SPTA. SPTA. SPTA. SPTA.
3 33 3

The derated spatial-peak temporal-average intensity (milliwatts per square centimeter).
I II I
SPPA. SPPA. SPPA. SPPA.
3 33 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 Ml Ml 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 PP P
R.3 R.3 R.3 R.3
The derated peak rarefactional pressure (megapascals) associated with the transmit pattern giving
rise to the value reported under MI.
W WW W
o oo 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 ff f
c cc 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 zz z
SP SP SP SP
The axial distance at which the reported parameter is measured (centimeters).
x xx x
- -- -6, 6, 6, 6,
y yy y
- -- -6 66 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 PD PD PD Pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value
of the respective parameter.
PRF PRF PRF PRF Pulse repetition frequency (Hz) associated with the transmit pattern giving rise to the reported
value of the respective parameter.
EBD EBD EBD EBD Entrance beam dimensions for the azimuthal and elevational planes (centimeters).
EDS EDS EDS EDS Entrance dimensions of the scan for the azimuthal and elevational planes (centimeters).


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II /10
2.8.2.1. A-Scan probe (option)

Probe reference Probe reference Probe reference Probe reference TP-01-b / TP-02-las (ProBeam)
Type Type Type Type A-scan

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

I II I
SPTA.3 SPTA.3 SPTA.3 SPTA.3

0.140 mW/cm
2

I II I
SPPA.3 SPPA.3 SPPA.3 SPPA.3

11.611 W/cm
2

Mechanical Mechanical Mechanical Mechanical index index index index 0.16
Ultrasonic power Ultrasonic power Ultrasonic power Ultrasonic power 0.013 mW
Transducer model Transducer model Transducer model Transducer model TP-01-b / TP-02-las (ProBeam)
Operating Mode Operating Mode Operating Mode Operating Mode A-Scan
Application Application Application Application Ophthalmic biometer

Acoustic output Acoustic output Acoustic output Acoustic output MI MI MI MI
I II ISP SP SP SPT TT TA.3 A.3 A.3 A.3
(mW/ cm (mW/ cm (mW/ cm (mW/ cm
2 22 2
) )) )
I II ISPPA.3 SPPA.3 SPPA.3 SPPA.3
(W/ cm (W/ cm (W/ cm (W/ cm
2 22 2
) )) )
Maximum Value Maximum Value Maximum Value 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

A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

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
a
r
a
m
e
t
e
r
s
P
a
r
a
m
e
t
e
r
s
P
a
r
a
m
e
t
e
r
s

Pr.3 (Mpa) 0.480
W0 (mW) 0.013 0.013
fc (MHz) 8.83 8.83 8.83
Zsp (cm) 2.00 2.00 2.00
Beam
Dimension
X-6 (cm) 0.168 0.168
Y-6 (cm) 0.166 0.166
PD (m) 0.11 0.126
PRF (Hz) 108 108
EBD
Az (cm) 0.5
E1 (cm) 0.5


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II /11
2.8.2.2. B-Scan probe (option)
Probe reference Probe reference Probe reference Probe reference B1
Type Type Type Type B mode
Material Material Material Material Composite material
Pulse repetition frequency Pulse repetition frequency Pulse repetition frequency Pulse repetition frequency 4655 Hz

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

I II I

0.22 mW/cm
2

I II I

24.3 W/cm
2

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

2 22 2
) )) )
2 22 2
) )) )
A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

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
a
r
a
m
e
t
e
r
s
P
a
r
a
m
e
t
e
r
s
P
a
r
a
m
e
t
e
r
s

Pr.3 (Mpa) 0.56
W0 (mW) 0.208 0.208
fc (MHz) 8.85 8.85 8.85
Zsp (cm) 2.7 2.7
Beam
Dimension
X-6 (cm) 0.094
Y-6 (cm) 0.09
PD (s) 0.09 0.09
PRF (Hz) 2844 2844
EBD
Az (cm) 1.41
Ele (cm) 0.75


XE_CTT_ME_AN_140905

II /12
2.8.2.3. Pachymeter probe

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

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

I II I

0.097 mW/cm
2

I II I

0.655 W/cm
2

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

2 22 2
) )) )
2 22 2
) )) )
A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

A
s
s
o
c
i
a
t
e
d

A
c
o
u
s
t
i
c

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
a
r
a
m
e
t
e
r
s
P
a
r
a
m
e
t
e
r
s
P
a
r
a
m
e
t
e
r
s

Pr.3 (Mpa) 0.15
W0 (mW) 0.0009 0.0009
fc (MHz) 13.14 13.14 13.14
Zsp (cm) 0.200 0.200 0.200
Beam
Dimension
X-6 (cm) 0.100 0.100
Y-6 (cm) 0.104 0.104
PD (s) 0.05 0.05
PRF (Hz) 2800 2800
EBD
Az (cm) 0.12
E1 (cm) 0.12

Accuracy in pachymetry mode Accuracy in pachymetry mode Accuracy in pachymetry mode 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.

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


XE_CTT_ME_AN_140905

II /13
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 NOTE NOTE 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. 3. 3. 3. COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH: EMC DATA AND GUIDELINES : EMC DATA AND GUIDELINES : EMC DATA AND GUIDELINES : EMC DATA AND GUIDELINES

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

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

Guidance and manufacturers declaration Guidance and manufacturers declaration Guidance and manufacturers declaration Guidance and manufacturers declaration electromagnetic emissions electromagnetic emissions electromagnetic emissions electromagnetic emissions
The The The The COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH is intended for use in the electromagnetic environment specified below. The is intended for use in the electromagnetic environment specified below. The is intended for use in the electromagnetic environment specified below. The is intended for use in the electromagnetic environment specified below. The
operator of the operator of the operator of the operator of the COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH has to make sure that it is used in such an environment. has to make sure that it is used in such an environment. has to make sure that it is used in such an environment. has to make sure that it is used in such an environment.
Emission test Emission test Emission test Emission test Compliance Compliance Compliance Compliance Electromagnetic environment Electromagnetic environment Electromagnetic environment Electromagnetic environment - -- -
Guidance Guidance Guidance Guidance
RF emission acc. to RF emission acc. to RF emission acc. to RF emission acc. to
EN 55011 EN 55011 EN 55011 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 RF emissions acc. to RF emissions acc. to RF emissions acc. to
EN 55011 EN 55011 EN 55011 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 Harmonic emissions acc. to Harmonic emissions acc. to Harmonic emissions acc. to
IEC 61000 IEC 61000 IEC 61000 IEC 61000- -- -3 33 3- -- -2 22 2
Class A
Voltage fluctuations / Voltage fluctuations / Voltage fluctuations / Voltage fluctuations /
Flicker emissions acc. to Flicker emissions acc. to Flicker emissions acc. to Flicker emissions acc. to
IEC 61000 IEC 61000 IEC 61000 IEC 61000- -- -3 33 3- -- -3 33 3
Complies


XE_CTT_ME_AN_140905

II /14

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

The The The The COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator
of the of the of the of the COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH has to ensure that it is used in such an environment. has to ensure that it is used in such an environment. has to ensure that it is used in such an environment. has to ensure that it is used in such an environment.
Immunity Immunity Immunity Immunity
Test Test Test Test
CEI 60601 test CEI 60601 test CEI 60601 test CEI 60601 test
level level level level
Compliance Compliance Compliance Compliance
level level level level
Electromagnetic environment Electromagnetic environment Electromagnetic environment Electromagnetic environment - -- - Guidance Guidance Guidance 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 Recommended Recommended Recommended separation distance: separation distance: separation distance: separation distance:
Conducted Conducted Conducted Conducted
RF RF RF RF
disturbances disturbances disturbances disturbances
according to according to according to according to
IEC 61000 IEC 61000 IEC 61000 IEC 61000- -- -4 44 4- -- -6 66 6

3 Veff
150 kHz to 80
MHz

10 V

P d 35 , 0 =

Radiated RF Radiated RF Radiated RF Radiated RF
disturbances disturbances disturbances disturbances
according to according to according to according to
IEC 61000 IEC 61000 IEC 61000 IEC 61000- -- -4 44 4- -- -3 33 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 NOTE 1: At 80 MHz and 800 MHz the separation distance for the NOTE 1: At 80 MHz and 800 MHz the separation distance for the NOTE 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies. higher frequency range applies. higher frequency range applies. higher frequency range applies.
NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, and reflection from structures, and reflection from structures, and reflection from structures, objects and people. objects and people. objects and people. objects and people.
a aa a
Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and land mobile Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and land mobile Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and land mobile Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To as accuracy. To as accuracy. To as accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site sess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site sess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site sess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the device survey should be considered. If the measured field strength in the location in which the device survey should be considered. If the measured field strength in the location in which the device survey should be considered. If the measured field strength in the location in which the device COMPACT COMPACT COMPACT COMPACT
TOUCH TOUCH TOUCH TOUCH is used exceeds the applicable RF compliance level abov is used exceeds the applicable RF compliance level abov is used exceeds the applicable RF compliance level abov is used exceeds the applicable RF compliance level above, additional measures may be necessary, e, additional measures may be necessary, e, additional measures may be necessary, e, additional measures may be necessary,
such as reorientation or relocating the such as reorientation or relocating the such as reorientation or relocating the such as reorientation or relocating the COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH. In case unusual performance is witnessed, . In case unusual performance is witnessed, . In case unusual performance is witnessed, . In case unusual performance is witnessed,
additional measures may be required such as change of orientation or location of the additional measures may be required such as change of orientation or location of the additional measures may be required such as change of orientation or location of the additional measures may be required such as change of orientation or location of the COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH. .. .
b bb b
Field strengt Field strengt Field strengt Field strength should be less than 3 V/m in the range between 150 kHz and 80 MHz h should be less than 3 V/m in the range between 150 kHz and 80 MHz h should be less than 3 V/m in the range between 150 kHz and 80 MHz h should be less than 3 V/m in the range between 150 kHz and 80 MHz


XE_CTT_ME_AN_140905

II /15

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

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

Maximum transmitter Maximum transmitter Maximum transmitter Maximum transmitter
power output (W) power output (W) power output (W) power output (W)
Separation distance according to the transmitters frequency (m) Separation distance according to the transmitters frequency (m) Separation distance according to the transmitters frequency (m) Separation distance according to the transmitters frequency (m)
150 150 150 150 kHz to 80 MHz kHz to 80 MHz kHz to 80 MHz kHz to 80 MHz

P d 35 , 0 =

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

P d 35 , 0 =

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

P d 7 , 0 =

0,01 0,01 0,01 0,01 0,035 0,035 0,07
0,1 0,1 0,1 0,1 0,11 0,11 0,22
1 11 1 0,35 0,35 0,70
10 10 10 10 1,1 1,1 2,2
100 100 100 100 3,5 3,5 7,0

For transmitters rated at a maximum output power not listed above, the recommended separation distance For transmitters rated at a maximum output power not listed above, the recommended separation distance For transmitters rated at a maximum output power not listed above, the recommended separation distance For transmitters rated at a maximum output power not listed above, the recommended separation distance d dd d
in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P PP P is is is is
the maximum emission output power of the the maximum emission output power of the the maximum emission output power of the the maximum emission output power of the transmitter in watts (W) according to the transmitter transmitter in watts (W) according to the transmitter transmitter in watts (W) according to the transmitter transmitter in watts (W) according to the transmitter
manufacturer. manufacturer. manufacturer. manufacturer.

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

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by affected by affected by affected by
absorption and reflection from structures, objects and people. absorption and reflection from structures, objects and people. absorption and reflection from structures, objects and people. absorption and reflection from structures, objects and people.


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Guidance and manufacturer declaration Guidance and manufacturer declaration Guidance and manufacturer declaration Guidance and manufacturer declaration electromagnetic immunity electromagnetic immunity electromagnetic immunity electromagnetic immunity
The The The The COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator is intended for use in the electromagnetic environment specified below. The operator
of the of the of the of the COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH COMPACT TOUCH has to ensure that it is used in such an environment. has to ensure that it is used in such an environment. has to ensure that it is used in such an environment. has to ensure that it is used in such an environment.
Immunity Test Immunity Test Immunity Test Immunity Test CEI 60601 test level CEI 60601 test level CEI 60601 test level CEI 60601 test level Compliance level Compliance level Compliance level Compliance level Electromagnetic environment Electromagnetic environment Electromagnetic environment Electromagnetic environment - -- -
Guidance Guidance Guidance Guidance
Electrostatic Electrostatic Electrostatic Electrostatic
discharge (ESD) discharge (ESD) discharge (ESD) discharge (ESD)
acc. to IEC 61000 acc. to IEC 61000 acc. to IEC 61000 acc. to IEC 61000- -- -
4 44 4- -- -2 22 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 Electrical fast Electrical fast Electrical fast
transients/ burst transients/ burst transients/ burst transients/ burst
acc. to IEC 61000 acc. to IEC 61000 acc. to IEC 61000 acc. to IEC 61000- -- -
4 44 4- -- -4 44 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 Surge acc. to IEC Surge acc. to IEC Surge acc. to IEC
61000 61000 61000 61000- -- -4 44 4- -- -5 55 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, Voltage dips, Voltage dips, Voltage dips,
short short short short- -- -term term term term
interruptions and interruptions and interruptions and interruptions and
voltage voltage voltage voltage
variations on variations on variations on variations on
power supply power supply power supply power supply
input lines acc. input lines acc. input lines acc. input lines acc.
to 61000 to 61000 to 61000 to 61000- -- -4 44 4- -- -11 11 11 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 Power frequency Power frequency Power frequency
(50/60Hz) (50/60Hz) (50/60Hz) (50/60Hz)
magnetic fields magnetic fields magnetic fields magnetic fields
acc. to IEC acc. to IEC acc. to IEC acc. to IEC 61000 61000 61000 61000- -- -
4 44 4- -- -8 88 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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4. 4. 4. 4. UNIT DESCRIPTION & INSTALLATION UNIT DESCRIPTION & INSTALLATION UNIT DESCRIPTION & INSTALLATION UNIT DESCRIPTION & INSTALLATION
The connectors have different shape to avoid installation errors.

Do not force on the connectors
4.1. Right Panel

Main switch Main switch Main switch 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.

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 Power supply Power supply Power supply 2.5mm Supply Connector.
Footswitch connector Footswitch connector Footswitch connector Footswitch connector It is the Audio type connector next to the handle.
B BB B- -- -Scan probe Scan probe Scan probe Scan probe
connector connector connector connector
B-probe (10MHz) can be plugged into this connector.
Biometry probe Biometry probe Biometry probe Biometry probe
The biometry probe has a LEMO four-pin connector. It is a push-pull type connector
with a locking system.
Pachymetry probe Pachymetry probe Pachymetry probe Pachymetry probe
A pachymetry probe can be plugged into this rotative BNC connector

Main switch
Power supply
12Vdc
Pachymetry probe
Biometry probe:
TP-01b/TP-02-las
B Probe
Footswitch


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4.2. Left Panel

USB 2.0 connectors USB 2.0 connectors USB 2.0 connectors USB 2.0 connectors
There are 2 USB connectors: used for printer or data storage key or external
keyboard
Network connector (RJ Network connector (RJ Network connector (RJ Network connector (RJ- -- -45) 45) 45) 45) This connector is used to connect the COMPACT TOUCH to a network

2 USB Ports
Network port


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4.3. Front Panel

Ref. Ref. Ref. Ref. Description Description Description Description
1 11 1 Color LCD LED touchscreen
2 22 2 Start button
3 33 3 Power supply LED:
Orange: the COMPACT TOUCH is powered
Green: the COMPACT TOUCH is started
4 44 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 55 5 B1 probe holder (including biometry probe holder)
6 66 6 Biometry Test-Block: 10mm at 1550m/s
7 77 7 Pachymetry probe holder
8 88 8 Pachymetry Test-Block

2

8

7

1 4 3 6 5


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5. 5. 5. 5. Installation: technical information Installation: technical information Installation: technical information Installation: technical information
5.1. Probe holder assembling

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

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

Turn over the COMPACT TOUCH with care
Position the probe holder (main switch side). Insert the lug in the corresponding hole.
Screw on the hexagon socket screw (see below):

Probe holder for COMPACT TOUCH
B or AB:
Lug location
Hexagon socket
Screw location
Lug


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

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

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

Only connect the power supply provided by QUANTEL MEDICAL.


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5.4. Connections to the right and left panels
All connectors are located on the left and right panels of the unit. To avoid wrong connections, the
connectors have different shapes.

Do not force on connectors

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

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

Biometry Probe
TP-01-b / TP-02-las
Pachymetry
Probe option
B10 MHz
Probe
Footswitch
USB
ports
Network
port
Power supply


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

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

1a) Accessories installed in the Patient Environment are considered medical devices and must
comply with the IEC 60 601-1 standard.
The Patient Environment is defined as the area in which medical diagnosis, monitoring, or treatment is
carried out, as well as the area in which intentional or unintentional contact can occur between the
patient or other persons present and parts of the system.

1b) Non-medical electrical equipment may be connected to the COMPACT TOUCH in the following
conditions:
the equipment is at least 1.5 m from the Patient Environment;
the equipment is not touched by any person in close proximity of the patient.

2. Only connect to devices complying with these international standards:
IEC 60 601-1 Medical Electrical equipment
Or IEC 60 950-1 Safety of Information Technology equipment including electrical business equipment.


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5.5. Probe connections
5.5.1. Biometry probe
The Biometry probe is equipped with a push-pull type connector with a locking system. Before inserting
the connector, rotate it slightly to find the good position.

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

5.5.1.1. Standard probe (TP-01-b: Tono-PROBE)
The Biometry probe is uni-directional. Its small size allows it to be mounted on the Goldman tonometer in
place of the optical cone. The cable outlet along the tonometer stem does not disturb the balance of the
instrument, and the pressure regulation of the tonometer remains easily adjustable.

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

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

The biometry probe holder
is fixed on the right of the
COMPACT TOUCH (see
figure):
FRAGILE
HANDPIECE FOR TP-01-b A-Scan PROBE


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5.5.1.2. ProBeam Probe (TP-02-las)
ProBeam is an optional probe with a laser aiming beam.

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

Sticker on the ProBeam:

Use of the probe: Use of the probe: Use of the probe: Use of the probe:
In the acquisition screen, the probe is activated by pressing on the footswitch.when the footswitch is
pressed to get an unfrozen image (with the emission echo),. The ProBeam laser aiming beam is turned
ON. The patient should then fix the red point projected on the wall (or on the ceiling) so that the patients
eye to be measured and the ProBeam are in good alignment.

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

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

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

The A probe holder is located on the right side of the
COMPACT TOUCH (see figure).
5.5.4. Footswitch
The footswitch connector is located on the right panel.
Without ProBeam
(misalignment)
With ProBeam
(good alignment)


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

USB data storage device
External printer with a USB cable.
Additional USB keyboard
5.5.6. Network port
This port (located on the left panel) is used to connect the COMPACT TOUCH to a network.
5.5.7. Handle
The black handle can be used as a stand to tilt the device to a forward or backward position. Press both
sides on the rotating axis and turn the handle to the next position. A click can be heard when the handle
is locked to a specific position.

Rotating axis

User Manual
SEPTEMBER 2014
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2
0
0
8

Directive 93/42/EEC

CONTENTS REV*
1. STARTING UP THE SYSTEM .............................................................................................................................................. 1
1.1. Main switch .............................................................................................................................................................. 1
1.2. Switching on the unit .............................................................................................................................................. 1
2. STARTUP SCREEN ............................................................................................................................................................... 2
3. GENERAL SETUP SCREEN .................................................................................................................................................. 3
3.1. Setup screen parameters ...................................................................................................................................... 3
3.2. Functions bar............................................................................................................................................................ 4
4. PHYSICIAN SETUP SCREEN (CREATE / MODIFY / DELETE A PHYSICIAN) .............................................................. 6
4.1. Physician setup screen parameters ................................................................................................................... 6
4.2. Functions Bar ........................................................................................................................................................... 8
4.2.1. IOL setup................................................................................................................................................ 8
4.2.2. B mode Setup (option) ........................................................................................................................ 9
4.2.3. More information (Delete Physician) ............................................................................................ 10
4.2.4. Pachymetry setup (option) .............................................................................................................. 11
a) Default selection................................................................................................................... 11
b) Mapping ................................................................................................................................. 12
c) Measurement number ......................................................................................................... 12
d) IOP ........................................................................................................................................... 13
e) Velocity ................................................................................................................................... 14
f) Bias Value .............................................................................................................................. 14
g) Bias operator ......................................................................................................................... 14
h) Freeze ...................................................................................................................................... 14
i) Buzzer ..................................................................................................................................... 14
5. PATIENT SETUP SCREEN (CREATE / MODIFY / DELETE A PATIENT) ..................................................................... 15
5.1. Keratometry ............................................................................................................................................................ 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) ........................................................................................................ 18
6.1. Biometry .................................................................................................................................................................. 18
6.1.1. A-Probe preparation ......................................................................................................................... 18
6.1.2. Acquisition .......................................................................................................................................... 19
6.1.2.1. Functions description .......................................................................................................... 19
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

User manual:
III Using the device

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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.

User manual:

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2. STARTUP SCREEN

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

Icons Selecting the icon allows the user to:

Return to the previous screen (or startup screen).

Return to the Startup screen.

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

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

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

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

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

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

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

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

User manual:

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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:

User manual:

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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

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

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

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

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

User manual:

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III /5
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.

User manual:

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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)

User manual:

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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.

User manual:

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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)
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.

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.

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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

DOUGHTY
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
Pachymetry (m)
Correction
(mmHg)
405 7
425 6
445 5
465 4
485 3
505 2
525 1
545 0

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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.

565 -1
585 -2
605 -3
625 -4
645 -5
665 -6
685 -7
705 -8
Per cent Apply the bias value correction that is specified in percentage.
Plus Add the bias value to the measured value of the corneal thickness.
Minus Remove the bias value from the measured value of the corneal thickness.

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5. PATIENT SETUP SCREEN (CREATE / MODIFY / DELETE A
PATIENT)
Press the Patient file icon:

To search for a patient name type the first letter of the patient last name in the last name field: the list of
patients with this initial will be displayed in a pop up window on the right hand side of the screen.
Type *or % to display the patient list with all names.

NOTE:
To display the patients list, the fields in the Patient screen have to be empty. If not, click on the Next
patient button to erase all data in the patient screen fields and then type *or % to display the patient
lists.
To access a patient file, select the patient name in the displayed list on the right hand side of the screen.
To create a new patient, enter all patient data in the empty fields (Last name, first name, identification
number and/or birth date) and save.
To enter more information (gender, address and phone) press the More Patient Information button.
To delete the patient, press the More Patient Information button and then on Erase patient file.

When selecting a patient, the following screen is displayed:

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

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).

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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.

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


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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:

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.

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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.
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

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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.

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:

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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).

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)

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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.

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.

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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 guided with B10 probe)

State of acquisition
Unfrozen image (during
acquisition)
Frozen image
Action on
footswitch
Short pressure
(less than 1s)
Long pressure
(more than 1s)
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:

When selecting the icon :

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When selecting the icon :

Functions description

The knob allows the user to:
- adjust the default gain (during acquisition when the Area1 is
selected)
- adjust all the numeric fields as described in the next
functions (Gain, Dyn, TGC and Zoom fields)
- select the desired image from the Cineloop sequence as
described in the next function: Loop
- adjust the position of the CV line as described in the next
function: CV

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

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

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

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

This icon allows the user to display the Cineloop sequence

This icon allows the user to save the Cineloop sequence

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

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

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Functions description (next)
Slow speed
(sweeping
frequency = 9Hz):

Fast speed
(sweeping frequency
= 16Hz):

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

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

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

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

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

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

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

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

or

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

If the report is previewed / printed, all miniature images (saved images) containing this add to report
icon are incorporated.

NOTE:
In case the image is not saved, when selecting the Add to report function, the image is automatically
added to the report.
6.2.3. Mouse right click functions
By right clicking on the mouse on the displayed image of AREA 1, a menu appears with the following
choices:

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

Copy
To copy the image in the clipboard of Windows
Export to jpg
To save the image in jpg format
Background color
To modify the background color of the image
Selected color
To modify the color of the selected markers, tool.
Cineloop color
To modify the background color of the image when the
Cineloop is activated.
Delete image To delete a saved image
Add to report To add an image to the report.
Remove from report
To unselect an image that was previously added to the
report.
Clear report
Allows the user to unselect all images that were
previously added to the report.

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6.2.4. Footswitch functions for B Mode (as well as for Bio Mode guided with B10 probe)
The table below summarizes the footswitch functions for the two states of acquisition (frozen image /
unfrozen):

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

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

Press the same button again to stop the sequence.
To review the sequence image by image, press the loop field:
and turn the knob to select the desired image

To save the sequence, press on the following
icon:

The window hereby is displayed:

The sequence can be saved in:

The AVI format: file that can be read with Windows Media Player (for example).
COMPACT TOUCH format: that can be read with the COMPACT TOUCH software only.

State of acquisition
Unfrozen image (during acquisition) Frozen image
Action on footswitch
Short pressure (less
than 1s)
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.

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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.

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

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

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

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

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6.3.2. Acquisition mode: Automatic

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

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

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

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

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

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

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

Biometry
IOL Calculation
IOL table
Pachymetry
B mode
Exam History

For the acquisition screens (A mode (and Bio B), B mode and pachymetry) and IOL calculation screens, the user
can decide to print on a Video printer or on a Windows printer. Select the icon to display the following
printer selection screens :

A, Pachy and IOL calculation modes B mode

The user can choose to:
Automatically print the reports on the Windows printer selected by default. When the exam report is printed
on several pages: the patient last name, first name and ID are displayed on all pages. For B mode, all the
images previously selected will be printed two images per page.
Allows the user to choose the USB Video printer on which he wants to print its reports (A6). This choice is
only available if the Video printer option has been validated in the General Setup screen.
Preview the report before printing.
Clear report: to unselect all pre-selected images from the report.
Close Window: allows the user to close the printing window without printing, nor unselecting the report
images.

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

.

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

By using the Preview Report function: the report will be displayed on the screen. Click on the function:
to print it out.

Select Print on Windows printer or Preview Report
and then Print:
Print on USB Video printer

NOTE:

With a Windows compatible printer: if the measurements have been performed on both eyes, the results
will be printed out on the same page

With the USB video printer, only the eye displayed on the screen will be printed with the A6 format.

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

printer.
to print it out.

Windows printer :

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

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

- The average
- The chosen line that has been selected
in the result table by the user
- The (TL and AC) values which can
be modified by the user in the IOL
screen.

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USB Video printer

7.3. Printing from the B mode examination screen
Perform an acquisition from the B mode exam screen. Press the following icon: .
printer.
to print it out.

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: .

printer.
to print it out.

Windows printer USB Video printer

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

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7.5. Printing from the exam history
In the Patient screen, select the Exam History function.
Select the exam to print and click on the Load Report function. Press the following icon: .
The report is displayed on the screen. Select the function to print it out.
7.6. Preview report

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

Functions description:

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

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

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

User Manual:
IV - Maintenance
SEPTEMBER 2014
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2
0
0
8

Directive 93/42/EEC

CONTENTS REV*
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

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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.

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2.1.1. Calibration check:
1) From the Startup screen: press the General Setup function
2) In the General Setup screen, select the BIOMETRY MODE (or the PROBEAM MODE) field (probe
for which the calibration has to be done):

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

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

4) Put a drop of water on the Test-Block and adjust the 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

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IV /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

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IV /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.

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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:
MAY 2014
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 JAIME ARAMBERRI) ............................................................... 3
1.5. BINKHORST II ........................................................................................................................................ 4
1.6. HOLLADAY .............................................................................................................................................. 5
1.7. HOFFER-Q ................................................................................................................................................ 6
1.8. SHAMMAS ............................................................................................................................................. 7
1.9. HAIGIS ..................................................................................................................................................... 8
2. IOL CALCULATION FOR POST REFRACTIVE SURGERY ........................................................................... 10
2.1. HISTORY DERIVED / DOUBLE K SRKT METHODS (CASE 1: WHEN ALL THE PATIENT
HISTORY IS KNOWN): .................................................................................................................. 11
2.2. REFRACTION DERIVED METHOD (CASE 2: ONLY THE REFRACTIONS ARE KNOWN):.... 12
2.3. ROSA / SHAMMAS (CASE 3: UNKNOWN PATIENT HISTORY: CORRECTED K VALUE) .. 13
A. ROSA .................................................................................................................................... 13
B. SHAMMAS.......................................................................................................................... 13
2.4. CONTACT LENS METHOD (CASE 4: UNKNOWN PATIENT HISTORY: EVALUATED POST-
OP K) ............................................................................................................................................... 14

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V Appendix IOL formulae

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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

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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)]

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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)]

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1.5. BINKHORST II
Used Variables:

Lb: Axial length corrected for Binkhorst II.

Lb = LA + 0.1984 mm

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

If Lb < 26 then ACD-b = ACD x (LA / 23.45)
If Lb >= 26 then ACD-b = ACD x (26 / 23.45)
So ACD-b = 1.1087 x ACD

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

FORMULA GIVING THE IMPLANT VALUE VERSUS THE DESIRED REFRACTION: REF

IOL = Vs (Ref) if Ref =0 IOL= IOLem (emmetropia)

IOL =
1336 [ 1.336R 0.3333Lb 0.001Ref (16,032R 4Lb + Lb. R) ]
(Lb AC) [ 1.336R 0.3333AC 0.001Ref (16.032R 4AC + AC. R ]

FORMULA GIVING THE REFRACTION VERSUS THE DESIRED IMPLANT: IOLAM

Ref = Vs (IOL)

Ref =
1336(1.336R 0.3333Lb) IOL. (Lb AC) (1.336R 0.3333AC)
1.336(16.032R 4Lb + LbR) 0.001IOL(Lb AC) (16.032R 4AC + AC. R)

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1.6. HOLLADAY
Used Variables:
R:
Cornea curvature in mm = 337.5 / K (K in Diopters)
Ref
Target Refraction.

Lh: Axial length corrected for HOLLADAY.

Lh = AL + 0.200 mm

SF: Surgeon Factor: specific for Holladay formula.

SF = (A x 0.5663) - 65.60 where A is the SRK Constant

ACh: Anterior Chamber corrected for HOLLADAY.

Rag = R exept if R < 7mm then Rag = 7 mm

AG = (12.5 / 23.45) AL so : AG = 0.533.AL

except if AG > 13.5 then AG = 13.5 mm

ACD = 0.56 + Rag - [SQRT (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)

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1.7. HOFFER-Q
Used Variables:
P: Implant POWER (D)
R: Refractive error at corneal plane (D).
Rx:
Desired ametropia : Refractive error at spectacle (D).
K: Average Keratometry (D)
CD:
Corrected Chamber Depth (mm).
ACD: Anterior chamber depth from the personalized IOL User file.
AL: Axial Length (mm)

CORRECTED CHAMBER DEPTH:

If AL <= 23 M = +1 and G = 28
If AL > 23 M = -1 and G = 23.5

If AL > 31 AL = 31
If AL < 18.5 AL = 18.5

CD = ACD + 0.3(AL - 23.5) + (tan K)
2
+ 0.1M (23.5 - AL)
2
tan [0.1(G - AL)
2
] - 0.99166

EMMETROPIA POWER:

R = Rx / (1 - 0.012Rx)

P = [1336 / (AL - CD - 0.05)] - {1.336 / [(1.336 / (K + R)) - ((CD + 0.05) / 1000)]}

FORMULA GIVING THE REFRACTION (RX) VERSUS THE
DESIRED IMPLANT: IOLAM

Rx = vs (IOLam)

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

Rx = R / (1 + 0.012R)

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1.8. SHAMMAS

KERATOMETRY CORRECTION:

KS = 1.14 Kpost 6.8
Where Kpost is the measurement of the Keratometry by classical means.

IOL CALCULATION FOR EMMETROPIA

IOLemm = (1336 / (L 0.1 (L 23) C -0.05)) (1 / ((1.0125 /K) ((C + 0.05) / 1336)))

IOLemm =
1336
L 0.1(L 23) C 0.05

1

1.0125
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

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V /8
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1.9. HAIGIS
Formulas for the IOL calculation according to HAIGIS (W. Haigis)
1. IOL power for given refraction Dl:

All calculations are based on the "Thin-lens-formula":
(1)

With:
(2)

Where:

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

2. Refraction Rx for given IOL power:
From (1), the following equation for the resultant refraction Rx for an IOL power Dl and an optical ACD d:
(3)

Where:

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.

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)]

User manual:

V /9
XE_CTT_ME_AN_140905

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
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, Jan.25th , 2000; Dr.W.Haigis

User manual:

V /10
XE_CTT_ME_AN_140905

2. IOL calculation for Post Refractive surgery
IOL calculations by classical means turned out to be wrong for a lot of patients who got a cataract few
years after refractive surgery (RK, PRK ou Lasik), indeed:
The keratometry measured by classical means was over estimated.
Using this K value, the calculated IOL power was underestimated and the patient then got hyperopia
after implantation.
The goal of the Post-refractive surgery cases program is to:
Estimate the real curvature of the cornea.
Calculate the correct IOL value.

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

Keratometry information:

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

Available methods & formulae when historical patient
data is known.

Available methods & formulae when historical patient
data is NOT known.

NOTE
The post-op refraction can easily be determined using the last spectacles correction information.

NOTE
A cataract may affect refraction, so that a direct evaluation may be altered.
Historical Data is
known
Pre-op
Keratometry
Pre-op
Refraction
Khd
History
derived
IOL
All
formulae
IOL
Double
K/SRK-T
Only Pre-op
Refraction
Current K
Measurement
Krd
Refraction
derived
IOL
All
formulae
No Historical Data is
known
Current K
Measurement
TL Measurement
KR
ROSA
IOL
SRK-T
SRK-II if
TL>29.4mm
KS
SHAMMAS
IOL
SHAMMAS
Refraction with
Contact Lens
Kcl
Contact Lens
IOL
All
formulae

User manual:

V /11
XE_CTT_ME_AN_140905

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

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

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

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

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

User manual:

V /12
XE_CTT_ME_AN_140905

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:

User manual:

V /13
XE_CTT_ME_AN_140905

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.

User manual:

V /14
XE_CTT_ME_AN_140905

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.

Manual User Compact Touch XE CTT ME An 140905

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