Compact Touch User Manual: Select A Chapter

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
MARCH 2015
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
2008
Directive 93/42/EEC
This QUANTEL MEDICAL equipment, including the associated software and documentation are
proprietary products of QUANTEL MEDICAL under international copyright law and all rights are
reserved. This manual may only be reproduced in whole or in part with written permission of QUANTEL
MEDICAL. This manual is furnished for informational use only and QUANTEL MEDICAL reserves the right
to modify the equipment characteristics and manual without previous notice. Photos and diagrams are
not contractual. QUANTEL MEDICAL cannot be held responsible for any damage or injury which results
from a failure to follow, or incorrect use of, the instructions contained in this manual. The guarantee of
the equipment will be void if the equipment is opened (even partially), modified or repaired in any way by
persons who are not authorized by QUANTEL MEDICAL.
Any question regarding the installation or the use of the COMPACT TOUCH system should be directed to
the QUANTEL MEDICAL Service Department or to a local distributor:
International U.S.A.
QUANTEL MEDICAL QUANTEL USA MEDICAL UNIT

11, rue du bois joli, 601, Haggerty Lane
63808 Cournon dAuvergne BOZEMAN MT 59715
FRANCE U.S.A.
Tel. : +33 (0) 473 745 745 Tel : +1 888 660 6726
Fax : +33 (0) 473 745 700 Fax : +1 (406) 586 2924
E-mail : contact@quantel-medical.fr E-mail : info@quantelmedical.com
Web site: www.quantel-medical.com Web site www.quantel-medical.com
2015 QUANTEL MEDICAL

All rights reserved
COMPACT TOUCH User Manual
Software Version 4.00
International version
(Ref: XE_CTT_ME_AN)
March 19th, 2015
User Manual
Introduction
MARCH 2015
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2008
Directive 93/42/EEC
CONTENTS REV*
1. INTRODUCTION............................................................................................................................................................. 1
2. USER MANUAL DESCRIPTION .................................................................................................................................. 1
3. USER MANUAL TERMS AND SAFETY SYMBOLS.................................................................................................. 1
4. UNPACKING THE INSTRUMENT ............................................................................................................................... 2
5. PACKING LIST ............................................................................................................................................................... 2

User manual:
Introduction
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.
XE_CTT_ME_AN_150319 Intro /1
User manual:
Introduction
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)
Intro /2 XE_CTT_ME_AN_150319
User Manual:
I - Regulatory & safety information
MARCH 2015
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2008
Directive 93/42/EEC
CONTENTS REV*
1. INTENDED USE AND CONTRAINDICATIONS ................................................................................................... 1
2. SAFETY INFORMATION AND PRECAUTIONS .................................................................................................. 1
2.1. General warnings and cautions information..................................................................................................... 1
2.2. Probes care / WARNINGS and CAUTIONS ....................................................................................................... 2
2.3. How to prevent a transfer of infection ............................................................................................................... 3
2.3.1. Pre-disinfection and disinfection procedures / Europe .................................................................... 3
2.3.2. Pre-disinfection and disinfection procedures / USA only ................................................................ 3
2.3.3. Finger cots ................................................................................................................................................... 3
2.4. Precautions to take concerning wastes and elimination of device and accessories ............................. 4
User manual:
I Regulatory & safety
information
1. INTENDED USE AND CONTRAINDICATIONS

The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used
with it are indicated for diagnostic imaging and biometric measurement of the eye including:
Visualization of the interior of the eye and the orbit by A and B scans.
Axial Length measurement of the eye by ultrasonic means.
Implanted IOL power calculation, using the Axial Length measurement.
Measurement of corneal thickness by ultrasonic means.
2. SAFETY INFORMATION AND PRECAUTIONS

2.1. General warnings and cautions information
Tissue exposure to ultrasound energy: The COMPACT TOUCH unit is designed for use in ophthalmology
only. While QUANTEL MEDICAL is not aware of any reports of adverse effects from using
ophthalmologic ultrasound biometry, no other use is intended or implied. The system controls limit the
output energy to within the parameters specified for its intended purpose. No control of ultrasound
energy is available to the user other than the duration of exposure.
WARNINGS
This device is required to be sold only by on the prescription of a physician.
This device is not intended for foetal use.
Disconnect AC power before cleaning the case.
AC power should be disconnected every time after turning the system OFF
To avoid risk of electric shock, this equipment must only be connected to supply mains with protective
earth.
While using the unit, mains plug must be easily accessible.
The COMPACT TOUCH IOL calculator will calculate negative IOL values if such is predicted by the
entered data. These are displayed with a minus sign (-). Do not ignore this sign!
Be careful not to compress the cornea when measuring axial length.
No modification of this equipment is allowed.
Before adding any other equipment to the basic configuration, please refer to the:
COMPACT TOUCH User Manual: Chapter II - Technical information
Section 5.4 Connections to the right and left panels
Do not modify the equipment without authorization of the manufacturer.
In case the equipment is modified, appropriate inspection and testing must be conducted to ensure
continued safe use of the equipment.
Only connect Medical Electrical Equipment which has been specified as some parts of the equipment or
as compatible with the equipment.
The COMPACT TOUCH has to be disconnected from the telecom, IT network and/or USB accessories
during examination.
Only use a network device or USB accessories that comply with IEC 60601-1 and IEC 60950 standards.
When new equipment (not delivered by QUANTEL MEDICAL) is connected to the equipment (via USB,
network...), the leakage current measurements and checks have to be performed by the responsible
organization with the new equipment installation: clause 16 IEC 60601-1 third edition.
XE_CTT_ME_AN_150319 I/1
User manual:
information
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.
XE_CTT_ME_AN_150319
I/2
User manual:
information
2.3. How to prevent a transfer of infection

2.3.1. Pre-disinfection and disinfection procedures / Europe
WARNINGS
Between two patients, the probes and scleral shells must be cleaned to prevent patient-to-patient
transfer of infection. QUANTEL MEDICAL recommends cleaning procedures:
QUANTEL MEDICAL devices pre-disinfection and disinfection procedures.
(Documentation code XE_SDE_PR_AN)
Probes & scleral shells must be disinfected prior to first use.
2.3.2. Pre-disinfection and disinfection procedures / USA only

Probes must be disinfected for each patient to prevent the transmission of infection. Follow the Centers
for Disease Control and Prevention (CDC) or institutional protocols for equipment sterilization.
Probes must also be disinfected prior to first use.
To disinfect a probe:
1. Clean the probe clean with a cloth. Ensure that all coupling medium and fluids are removed. The probe
tip may be wiped with an alcohol swab prior to soaking.
2. Disinfect the probe tip. CDC protocol suggests soaking the probe tip for 5-10 minutes in one of the
following solutions:
a. 70% isopropanol alcohol
b. 3% hydrogen peroxide
c. 1:10 dilution of chlorine bleach
3. Rinse the probe tip thoroughly in fresh water and allow to air dry.
Probes must not be heated (autoclave) or gas sterilized. Only clean the probes tip. Do not completely
submerge the probe in cleaning or rinsing solutions.
How to Disinfect Immersion Scleral Shells

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

Finger cots are a simple way of preventing probe contamination:
WARNING
The finger cots are for a single use only and must be replaced after each patient.
Equipment:
Preventive protection:
LATEX membrane
Nitrile membrane (prevents allergy to LATEX)
XE_CTT_ME_AN_150319 I/3
User manual:
information
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.
XE_CTT_ME_AN_150319
I/4
User Manual:
MARCH 2015
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2008
Directive 93/42/EEC
CONTENTS 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
1. LABELS
1.1. On the back panel
Identification label information:
Ref. Labels & Description

Identification label
Protection against electrical shocks: the applied parts are classified as

BF Type".
IEC 60417-5333
IEC protection class: "Class II
IEC 60417-5172
Refer to the instruction manual/ booklet

ISO 7010-M002
For indoor use only.
IEC 60417-5957
Electrical/electronic equipment in accordance with the Directive
2012/19/EU (WEEE)
Do not dispose with domestic household wastes.
EN 50419
General warning sign
ISO 7010-W001 General
This label specifies the manufacturing date indication.
ISO 7000-2497
Federal US law label :
XE_CTT_ME_AN_150319 II /1
User manual
1.2. On the right panel
Rf. Labels & Description

Power supply specifications
Probes & footswitch connectors label:
Footswitch
Options : Pachymetry A probe B

probe probe
1.3. On the left panel
Rf. Labels & Description

Standby icon
USB / NETWORK connector label
2 USB connectors (type 2.0)
Network port
II /2 XE_CTT_ME_AN_150319
User manual
1.4. Footswitch

Rf. Label

IP44 (According to IEC 60529):

- Protection against the penetration of foreign solid bodies of diameter 1 mm.
- Protection against splashing water.
Electrical/electronic equipment in accordance with the Directive 2012 /19 / EU (WEEE)

Do not dispose with domestic household wastes.
EN 50419
2. TECHNICAL SPECIFICATIONS
2.1. Classification
The system is intended for continuous operation and has the following classification:
Electric security class EN 60 601-1 Standard
Protective class II
Type BF (protection against electrical shocks)
2.2. Electrical requirements

CAUTION
Only connect the power supply module provided by QUANTEL MEDICAL.
Power supply External module with automatic voltage adaptation: no

selection is needed
Input voltage 100-240 Vac
Single phase without earth
Frequency 47-63 Hz
Mains consumption 70 VA
COMPACT TOUCH consumption 12 Vcc 5A
Class II
Reference TR60M12
Trade Mark Cincon Electronics
User manual
2.3. Compliance
STANDARD SUBJECT
Medical electrical equipment-Part 1: General requirements for basic safety and
IEC 60 601-1
essential performance
IEC 60 601-1-1
essential performance
IEC 60 601-1-2 essential performance Amendment electromagnetic compatibility requirements
and testing
Medical electrical equipment-Part 1-6: General requirements for basic safety and
IEC 60 601-1-6
essential performance Amendment: usability
IEC 60 529 Degree of protection provided by enclosure (IP code)
IEC 62 304 Medical device software Software life-cycle processus (IEC 62A/474/CDV)
Medical devices Application of risk management to medical devices (ISO/DIS
ISO 14 971
14971)
93/42/EEC European Medical Device Directive
2.4. Dimensions
Width: 37,5 cm (14,76 in)
Depth: 10 cm (3,94 in)
Height: 27 cm (10,63 in)
Weight: 4,280 kg (9,44 lbs)
2.5. Environmental conditions

The temperature of the room where the device is operated must be within the following range:
10 C < T < 35 C (50F < T < 95F)
The relative humidity must not exceed 95% without condensation

The Device storage and transportation temperature must be within the following range:
-20 C < T < 70 C (- 4F < T < 158F)
Maximum operating altitude: 2000m (about 7000 ft)
2.6. Echograph specifications

2.6.1. Biometry Probe (option)
TP-01-b (Tono-Probe)
Probe Reference
or TP-02-las (ProBeam)
Frequency 11 MHz
Focal Length 20 to 25 mm
Emission running mode Pulsed
Emission Repetition Rate 67 Hz
Active diameter 5 mm
Active surface 20 mm2
Axial resolution 0.15 mm (at - 6dB)
User manual
2.6.2. 10 MHZ B-SCAN Probe (option)

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

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

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

The accuracy is achieved by the electronic resolution: 0.03 mm
CAUTION
The global accuracy of the A-Scan is dependent upon:
A good alignment with the visual axis
A low pressure on cornea, especially when using the Contact Technique
2.6.6. Accuracy on IOL calculation

Display resolution on IOL power: 0.1 Diopter.
NOTE
Using the SRK II formula, a 0.2 mm accuracy in measurement results in an IOL difference of 0.5 diopter.
Using the other 4 formulas, a 0.15 mm accuracy in measurement results in an IOL difference of 0.5
diopter.
User manual
2.6.7. Physiological limits of measurements
Maximum
Physiological limits of measurements (auto) Minimum (mm)
(mm)
Anterior chamber at:
1.5 7
1532 m/s
Phakic Lens thickness at 1641 m/s 2.5 7
Total length = AC+L+V 14 45
Anterior chamber at:

1.5 7
1532 m/s
Pseudo-phakic Lens thickness at 1641 m/s 0.5 7
Total length = AC+L+V 14 45
Aphakic Total length at 1532 m/s 14 45
NOTE
These values correspond to the Automatic freezing control criteria.
On a manually frozen image, the markers being set manually there are no limits within the acquisition
depth of 60mm.
User manual
2.6.8. Data entry limits
The COMPACT TOUCH will accept values within the ranges listed below as valid data entries.
NOTE
Some of these are outside the range of normal ophthalmic physiological values.
Parameters Allowable range

Minimum Maximum
Anterior chamber, lens and vitreous 500 m/s 5000 m/s
velocities
Dense cataract velocity 500 m/s 5000 m/s
PMMA, acrylic and silicon IOL velocity 500 m/s 5000 m/s
Keratometry in millimeters 5 mm 13 mm
Keratometry in diopter 25.0 D 68.0 D
Sphere value -40.0D +20.0D
Cylinder value -40.0D +20.0D
Cylinder axis value 0 +180
Axis value for keratometry 0 +180
Total length in IOL calculation screen 15 mm 40 mm
Anterior chamber in IOL calculation screen 0 mm 9.9 mm
Post-operative ametropia -20.0 D +20.0 D
SRK A constant 113.00 120.59
Holladay surgeon factor calculated from A -1.61 +2.69
Hoffer-Q ACD 2.05 6.48
Binkhorst II post-op. anterior chamber 1 mm 8 mm
depth: ACDb
Constant for Haigis formula: a0 -10 +10
Constant for Haigis formula: a1, a2 -1 +1
Haigis constants: combined limits for a (1.16 -2 < a0 + 3.37 a1 + 23.39 a2 < 12
to 7mm) ACD range -2 < a0 + 2.53 a1 + 20.00 a2 < 12
-2 < a0+ 3.50 a1 + 27.00 a2 < 12
Speed in Pachy mode 200m 999m
User manual
2.7. Materials used

2.7.1. Housing
Upper frame Polyurethane plastic complying with the UL 94 V0 standard
Lower frame Painted steel sheet

LCD LED front panel Painted steel sheet
2.7.2. Probes (Housing and material in contact with the patient)

Body material Delrin 100
A-Scan Face material Insulcast I-124 Epoxy
Manufacturer Permagile
Body material Delrin 100
Pachymetry Face material REXOLITE 1422
Manufacturer Blatek
Body material Painted aluminium
B-Scan Face material TPX-MX002
Manufacturer Mitsui
2.8. Tissue Exposure to Ultrasound Energy

The COMPACT TOUCH unit is designed for use in ophthalmology only.
WARNING
This device is not intended for foetal use.
2.8.1. ALARA section (ALARA: as low as reasonably possible)

Ultrasound energy will always be attenuated by the tissue between the transducer and the focus when
used as recommended. The values presented here are the values at the focal point, the point of
maximum intensity.
It is not possible to vary the output energy of the transducer. However, to minimize exposure,
measurements should be kept as short as possible.
If more accuracy is desired, the intensity in the body at any transducer point may be calculated
according to the formula recommended by the FDA:
It = Iwexp(-0.069fz)
Where:
It = is the estimated in situ intensity
Iw is the measured intensity in water at the focus of the transducer
f is the ultrasonic frequency in megahertz
z is the distance from the face of the probe to the transducer focus in centimeters, which is the point of
measurement
This formula was also used to calculate the derated values shown above.
User manual
2.8.2. Sonic values

Transducer parameters show considerable variation from transducer to transducer. The measured and
calculated values given in the sections below (2.8.2.1 / 2.8.2.2 / 2.8.2.3) were those for 3 actual
transducers, whose values deviated slightly from the values in the specification above, and whose
values are likely to be different from the transducer of the users system. However, the values in the
specification should give results that are accurate enough for any practical purpose, since the
intensities are very low.
CAUTION:
It is always recommended to minimize exposure by limiting the ultrasonic transmission to as short
periods as possible.
Symbols used in the following tables are described below:

ISPTA.3 The derated spatial-peak temporal-average intensity (milliwatts per square centimeter).
ISPPA.3 The derated spatial-peak pulse-average intensity (watts per square centimeter). The value of
IPA.3 at the position of global maximum MI (IPA.3@MI) may be reported instead of ISPPA.3 if the
global maximum MI is reported.
Ml The Mechanical Index. The value of MI at the position of ISPPA 3, (MI@ISPPA.3) may be
reported instead of MI (global maximum value) if ISPPA.3 is < 190W/cm2.
PR.3 The derated peak rarefactional pressure (megapascals) associated with the transmit pattern
giving rise to the value reported under MI.
Wo The ultrasonic power (milliwatts). For the operating condition giving rise to ISPTA.3, Wo is the
total time-average power; for the operating condition subject to reporting under ISPPA.3, W0 is
the ultrasonic power associated with the transmit pattern giving rise to the value reported under
ISPPA.3.
fc The center frequency (MHz). For Ml and ISPPA.3 , fc is the center frequency associated with the
transmit pattern giving rise to the global maximum value of the respective parameter. For
ISPTA.3 , for combined modes involving beam types of unequal center frequency, fc is defined as
the overall range of center frequencies of the respective transmit patterns.
zSP The axial distance at which the reported parameter is measured (centimeters).
x-6, y-6 Are respectively the in-plane (azimuthal) and out-of-plane (elevational) -6dB dimensions in the x-
y plane where zsp is found (centimeters).
PD Pulse duration (microseconds) associated with the transmit pattern giving rise to the reported
value of the respective parameter.
PRF Pulse repetition frequency (Hz) associated with the transmit pattern giving rise to the reported
value of the respective parameter.
EBD Entrance beam dimensions for the azimuthal and elevational planes (centimeters).
EDS Entrance dimensions of the scan for the azimuthal and elevational planes (centimeters).
User manual
2.8.2.1. A-Scan probe
Probe reference TP-01-b / TP-02-las (ProBeam)

Type A-scan
Frequency 11 MHz
Ultrasonic intensities in tissue at measured transducer focus (about 22mm from probe tip).
ISPTA.3 0.140 mW/cm2

ISPPA.3 11.611 W/cm2
Mechanical index 0.16
Ultrasonic power 0.013 mW
Transducer model TP-01-b / TP-02-las (ProBeam)
Operating Mode A-Scan
Application Ophthalmic biometer
Acoustic output MI ISPTA.3 ISPPA.3

(mW/ cm2) (W/ cm2)
Maximum Value 0.16 0.140 11.611
Pr.3 (Mpa)
W0 (mW)
Associated Acoustic
fc (MHz)
Zsp (cm)
Parameters
Beam X-6 (cm)

Dimension Y-6 (cm)
PD (m)
PRF (Hz)
EBD Az (cm)
E1 (cm)
User manual
2.8.2.2. B-Scan probe (option)

Probe reference B1
Type B mode
Material Composite material
Frequency 10 MHz
Pulse repetition frequency 4655 Hz
Ultrasonic intensities in tissue at measured transducer focus (about 25mm from probe tip):
ISPTA.3 0.22 mW/cm2

ISPPA.3 24.3 W/cm2
Mechanical index 0.196
Transducer model 10 MHz Ophthalmic Probe
Operating Mode B-mode
Application Ophthalmic

(mW/ cm2) (W/ cm2)
Maximum Value 0.196 0.22 24.3
Pr.3
W0
Associated Acoustic
fc
Zsp
Parameters
Beam
Dimension
PD
PRF
EBD
User manual
2.8.2.3. Pachymeter probe (option)
Probe reference P1
Type A
Tip diameter 1.2mm
Active tip diameter 1.5mm
Focal point 0.5mm from the tip
Ceramic frequency 20MHz
Angle 45 degrees
Ultrasonic intensities in tissue at measured transducer focus (2mm from probe tip).
ISPTA.3 0.097 mW/cm2

ISPPA.3 0.655 W/cm2
Mechanical Index 0.04
Transducer model Pachymeter
Operating mode A-Scan
Application Ophthalmic Pachymeter

(mW/ cm2) (W/ cm2)
Maximum Value 0.04 0.097 0.655
Pr.3 (Mpa)
W0 (mW)
Associated Acoustic
fc (MHz)
Zsp (cm)
Parameters
Beam X-6 (cm)

Dimension Y-6 (cm)
PD (s)
PRF (Hz)
EBD Az (cm)
E1 (cm)
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
applying as little pressure as possible.
User manual
The default value of sound velocity, 1620 m/s, is considered to be the most standard value of velocity in
the cornea. Other values can only be used if they are specifically documented for the type of eye under
treatment.
NOTE
It is not recommended to modify the value of velocity in cornea.
The accuracy of the emissions given in the table above is: Power 29%, Pressure 14.6%, Intensities 29%,
Center frequency 2%, as defined by the spectrum of the pulse.
3. COMPACT TOUCH: EMC DATA AND GUIDELINES
WARNING
Medical electrical equipment needs special precautions regarding EMC. The following EMC guidelines
must be observed during installation and commissioning of the COMPACT TOUCH.
WARNING
Portable and mobile RF communications equipment can affect medical electrical equipment.
Guidance and manufacturers declaration electromagnetic emissions

The COMPACT TOUCH is intended for use in the electromagnetic environment specified below. The
operator of the COMPACT TOUCH has to make sure that it is used in such an environment.
Electromagnetic environment -
Emission test Compliance
Guidance
The COMPACT TOUCH uses RF energy
only for its internal functions.
RF emission acc. to
Group 1 Therefore, its RF emissions are very
EN 55011
low and are not likely to impair nearby
electronic equipment.
RF emissions acc. to
Class A The COMPACT TOUCH is suitable in all
EN 55011
establishments other than those in
Harmonic emissions acc. to
Class A living areas and those directly
IEC 61000-3-2
connected to the public low voltage
Voltage fluctuations / power supply network that also
Flicker emissions acc. to Complies supplies buildings used for living.
IEC 61000-3-3
User manual
Guidance and manufacturer declaration electromagnetic immunity
The COMPACT TOUCH is intended for use in the electromagnetic environment specified below. The operator
of the COMPACT TOUCH has to ensure that it is used in such an environment.
Immunity CEI 60601 test Compliance
Electromagnetic environment - Guidance
Test level level
Portable and mobile RF communications equipment should
be used no closer to any part of the COMPACT TOUCH,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:

Conducted
RF 3 Veff
disturbances 150 kHz to 80 10 V d 0,35 P
according to MHz
IEC 61000-4-6
Radiated RF
d 0,35 P for 80 MHz to 800 MHz
3 V/m
disturbances
80 MHz to 2,5 10 V/m
according to
IEC 61000-4-3
GHz d 0,7 P for 800 MHz to 2,5 GHz
Where P is the maximum emission output power of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strength from fixed RF transmitters, as determined by

an electromagnetic site surveya, should be less than the
compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked

with the following symbol:
NOTE 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
NOTE 2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
Field strength from fixed transmitters, such as base stations for radio (Cellular / cordless) and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the device COMPACT
TOUCH is used exceeds the applicable RF compliance level above, additional measures may be necessary,
such as reorientation or relocating the COMPACT TOUCH. In case unusual performance is witnessed,
additional measures may be required such as change of orientation or location of the COMPACT TOUCH.
b
Field strength should be less than 3 V/m in the range between 150 kHz and 80 MHz
User manual
Recommended separation distances between portable and mobile RF communications equipment and the
COMPACT TOUCH
The COMPACT TOUCH is intended for use in an electromagnetic environment in which the radiated RF
disturbances are controlled. The COMPACT TOUCH user can help prevent electromagnetic interference by
maintaining a minimal distance between portable and mobile RF communications equipment (transmitters) and
the COMPACT TOUCH as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to the transmitters frequency (m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5GHz
Maximum transmitter
power output (W)
d 0,35 P d 0,35 P d 0,7 P
0,01 0,035 0,035 0,07

0,1 0,11 0,11 0,22
1 0,35 0,35 0,70
10 1,1 1,1 2,2
100 3,5 3,5 7,0
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is
the maximum emission output power of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 : Between 80 MHz and 800 MHz, separation distance for the highest frequency range applies
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
User manual
Guidance and manufacturer declaration electromagnetic immunity

The COMPACT TOUCH is intended for use in the electromagnetic environment specified below. The operator
of the COMPACT TOUCH has to ensure that it is used in such an environment.
Electromagnetic
Immunity Test CEI 60601 test level Compliance level
environment - Guidance
Floors should be wood,
6 kV contact 6 kV contact concrete or ceramic tile. If
Electrostatic discharge discharge discharge floors are covered with
(ESD) acc. to IEC 61000-4-2 synthetic materials, the
8 kV air discharge 8 kV air discharge relative humidity should be
at least 30%.
2 kV for power supply 2 kV for power The quality of the supply
lines supply lines voltage should correspond
Electrical fast transients/
with one characteristic for a
burst acc. to IEC 61000-4-4
1 kV for input/ output 1 kV for input/ typical commercial or
lines output lines hospital environment.
The quality of the supply
1 kV differential
1 kV differential mode voltage should correspond
mode
Surge acc. to IEC 61000-4-5 with one characteristic for a
2 kV common mode typical commercial or
2 kV common mode
hospital environment.
The quality of the supply

voltage should correspond to
one characteristic for a
<5% during 0,5 period <5% during 0,5 period typical commercial or
Voltage dips, short-term hospital environment. If the
interruptions and voltage 40% during 5 periods 40% during 5 periods user of the COMPACT
variations on power supply TOUCH requires a
input lines acc. to 61000-4- 70% during 25 periods 70% during 25 periods continuous function of the
11 appliance also during
<5% during 5 s <5% during 5 s interruptions of the power
supply, it is recommended to
supply the COMPACT TOUCH
out of an uninterruptible
power supply or a battery
Power frequency magnetic
Power frequency (50/60Hz) fields should be at levels
magnetic fields acc. to IEC 3 A/m 30 A/m characteristic for
61000-4-8 commercial or hospital
environments
User manual
4. UNIT DESCRIPTION & INSTALLATION

The connectors have different shape to avoid installation errors.
WARNING
Do not force on the connectors
4.1. Right Panel
Main switch
Power supply
12Vdc
Footswitch
B Probe
Biometry probe:
TP-01b/TP-02-las
Pachymetry probe
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.
Main switch
CAUTION:
To prevent data loss, it is imperative to turn off the unit using the Start
button or the Windows 7 shut down procedure: Do not turn off the unit using
the main switch if the Windows shutdown process is not finished (turn on the
main switch when the power supply LED is orange).
Power supply 2.5mm Supply Connector.
Footswitch connector It is the Audio type connector next to the handle.
B-Scan probe
B-probe (10MHz) can be plugged into this connector.
connector
Biometry probe The biometry probe has a LEMO four-pin connector. It is a push-pull type connector
connector with a locking system.
Pachymetry probe
A pachymetry probe can be plugged into this rotative BNC connector
connector
User manual
4.2. Left Panel
2 USB Ports
Network port
USB 2.0 connectors There are 2 USB connectors: used for printer or data storage key or external
keyboard
Network connector (RJ-45) This connector is used to connect the COMPACT TOUCH to a network
User manual
4.3. Front Panel
8
7
1 4 3 6 5
Ref. Description
1 Color LCD LED touchscreen
2 Start button
Power supply LED:
3 Orange: the COMPACT TOUCH is powered
Green: the COMPACT TOUCH is started
The front knob may be used:
- to increase / decrease values
4
- to move the markers
- to move from one field to another one in specific screen
5 B1 probe holder (including biometry probe holder)
6 Biometry Test-Block: 10mm at 1550m/s
7 Pachymetry probe holder
8 Pachymetry Test-Block
User manual
5. Installation: technical information

5.1. Probe holder assembling
CAUTION
Before any intervention on the device, unplug the mains cord at the right side and remove all
connections.
Take the probe holder, the hexagon socket screw and its Allen key delivered with the COMPACT TOUCH.
Probe holder for COMPACT TOUCH

B or AB:
Lug
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):
Lug location
Hexagon socket
Screw location
User manual
5.2. Patient exam area

The patient exam area is diposed as follows:
5.3. Power supply

The power supply is an external module with an automatic voltage adaptation. It includes a 2.5mm
power supply connector. For more information, refer to the:
COMPACT TOUCH User Manual: Chapter II- Technical information

Section 2.2: Electrical requirements
CAUTION:
Only connect the power supply provided by QUANTEL MEDICAL.
User manual
5.4. Connections to the right and left panels

All connectors are located on the left and right panels of the unit. To avoid wrong connections, the
connectors have different shapes.
WARNING
Do not force on connectors
Biometry Probe
TP-01-b / TP-02-las Footswitch Power supply
Pachymetry B10 MHz

Probe option Probe
USB
ports
Network
port
CAUTION:
Only connect to devices complying with the international standard: IEC 60950 for Input and Output
signals.
CAUTION:
Do not connect USB unit (printer, mouse, keyboard) during acquisition.
User manual
CAUTION:
Be cautious when connecting devices other than the ones provided with the COMPACT TOUCH by
QUANTEL MEDICAL:
1. To comply with the IEC 60 601-1-1 Standard for Medical Systems, the configuration must respect the
following regulations:
1a) Accessories installed in the Patient Environment are considered medical devices and must
comply with the IEC 60 601-1 standard.
The Patient Environment is defined as the area in which medical diagnosis, monitoring, or treatment is
carried out, as well as the area in which intentional or unintentional contact can occur between the
patient or other persons present and parts of the system.
1b) Non-medical electrical equipment may be connected to the COMPACT TOUCH in the following
conditions:
the equipment is at least 1.5 m from the Patient Environment;
the equipment is not touched by any person in close proximity of the patient.
2. Only connect to devices complying with these international standards:

IEC 60 601-1 Medical Electrical equipment
Or IEC 60 950-1 Safety of Information Technology equipment including electrical business equipment.
User manual
5.5. Probe connections

5.5.1. Biometry probe
The Biometry probe is equipped with a push-pull type connector with a locking system. Before inserting
the connector, rotate it slightly to find the good position.
CAUTION:
Do not pull the cable to disconnect the probe. Pull the connector body to unlock it.
The biometry probe holder is fixed on the right of

the COMPACT TOUCH (see figure):
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.
FRAGILE
A hand-piece may be used to handle it more easily, either at 45 degrees or vertically
HANDPIECE FOR TP-01-b A-Scan PROBE
The probe hand-piece can be ordered through your local distributor or to QUANTEL MEDICAL. The
ordering code is XEAAAPAM.
User manual
5.5.1.2. ProBeam Probe (TP-02-las)

ProBeam is an optional probe with a laser aiming beam.
WARNING:
A laser radiation is emitted from the ProBeam probe, so avoid direct eye exposure.
Sticker on the ProBeam:
Use of the probe:

In the acquisition screen, the probe is activated by pressing on the footswitch .When the footswitch is
pressed to get an unfrozen image (with the emission echo), the ProBeam laser aiming beam is turned
ON. The patient should then fix the red point projected on the wall (or on the ceiling) so that the patients
eye to be measured and the ProBeam are in good alignment.
With ProBeam
(good alignment)
Without ProBeam
(misalignment)
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.
User manual
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
MARCH 2015
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2008
Directive 93/42/EEC
CONTENTS REV*
1. STARTING UP THE SYSTEM ............................................................................................................................................................ 1
1.1. Main switch.......................................................................................................................................................................... 1
1.2. Switching on the unit .......................................................................................................................................................... 1
2. STARTUP SCREEN ............................................................................................................................................................................ 2
3. GENERAL SETUP SCREEN................................................................................................................................................................ 3
3.1. Setup screen parameters................................................................................................................................................. 3*
3.2. Functions bar ..................................................................................................................................................................... 4*
4. PHYSICIAN SETUP SCREEN (CREATE / MODIFY / DELETE A PHYSICIAN) ............................................................................... 6
4.1. Physician setup screen parameters ................................................................................................................................. 6
4.2. Functions Bar ....................................................................................................................................................................... 8

4.2.1. IOL setup ............................................................................................................................................................. 8
4.2.2. B mode Setup (option) ........................................................................................................................................ 9*
4.2.3. Comments shortcuts list (B mode only) .......................................................................................................... 10*
4.2.4. More information (Delete Physician) ................................................................................................................ 11
4.2.5. Pachymetry setup (option) ................................................................................................................................. 12
a) Default selection ........................................................................................................................................... 12
b) Mapping ......................................................................................................................................................... 13
c) Measurement number ................................................................................................................................. 13
d) IOP .................................................................................................................................................................. 14
e) Velocity .......................................................................................................................................................... 15
f) Bias Value ...................................................................................................................................................... 15
g) Bias operator................................................................................................................................................. 15
h) Freeze ............................................................................................................................................................. 15
i) Buzzer............................................................................................................................................................. 15
5. PATIENT SETUP SCREEN (CREATE / MODIFY / DELETE A PATIENT) ...................................................................................... 16
5.1. Keratometry........................................................................................................................................................................ 17
5.2. Refraction data ................................................................................................................................................................ 17*
5.3. Keratometry for post-refractive surgery cases............................................................................................................. 18
5.4. Exam history ....................................................................................................................................................................... 19
5.5. Implanted IOL ..................................................................................................................................................................... 20
5.6. More information ............................................................................................................................................................... 20

6. ACQUISITION SCREENS (USING THE OPTIONS)........................................................................................................................ 20
6.1. Biometry.............................................................................................................................................................................. 20
6.1.1. A-Probe preparation ........................................................................................................................................... 20
6.1.2. Acquisition in biometry mode ............................................................................................................................ 21
6.1.2.1. Functions description ................................................................................................................... 21*
6.1.2.2. Automatic acquisition .................................................................................................................... 24
6.1.2.3. Conditions for automatic acquisition ........................................................................................... 25
6.1.2.4. Manual acquisition ......................................................................................................................... 25
6.1.2.5. Result table / Stat-2 calculation.................................................................................................. 26*
6.1.2.6. IOL calculation ................................................................................................................................ 27
a) Standard IOL calculation ........................................................................................................ 28
A. IOLs selection .................................................................................................................... 28
B. Formulae selection ........................................................................................................... 28
C. Post-operative ametropia ................................................................................................ 29
D. Increment........................................................................................................................... 29
b) Post Refractive IOL calculation ............................................................................................. 29
c) Saving the IOLs results ........................................................................................................... 29
d) Printing the IOLs results.......................................................................................................... 29
6.1.3. Biometry guided by B-Mode (COMPACT TOUCH B and AB)......................................................................... 30
6.1.4. Footswitch functions for A mode (review) ....................................................................................................... 31
6.2. B-Scan ................................................................................................................................................................................ 32

6.2.1. Functions description........................................................................................................................................ 32*
6.2.2. Add to report / Remove image from report ...................................................................................................... 35
6.2.3. Mouse right click functions.............................................................................................................................. 36*
6.2.4. Footswitch functions for B Mode ...................................................................................................................... 36
6.2.5. Cineloop sequence .............................................................................................................................................. 36
6.2.6. Post processing ................................................................................................................................................... 37
6.2.6.1. Caliper (To measure a distance)................................................................................................... 38
6.2.6.2. Marker (To indicate a particular point on the image and give comments)............................. 38
6.2.6.3. Area (To draw a field and calculate the surface area) ............................................................. 39
6.3. Pachymetry ........................................................................................................................................................................ 40

6.3.1. Acquisition mode: Center only ........................................................................................................................... 41
6.3.2. Acquisition mode: Automatic ............................................................................................................................. 42
6.3.3. Acquisition mode: Continuous ........................................................................................................................... 42
6.3.4. Acquisition mode: Scanning .............................................................................................................................. 43
7. PRINTING ......................................................................................................................................................................................... 44
7.1. Printing from the biometry mode acquisition screen ................................................................................................... 45
7.2. Printing from the IOL calculation screen: ...................................................................................................................... 46
7.3. Printing from the B mode examination screen .............................................................................................................. 47
7.4. Printing from the Pachymetry mode examination screen ........................................................................................... 48
7.5. Printing from the exam history......................................................................................................................................... 49
7.6. Preview report ........................................................................................................................................................... 49
7.7. Export in Excel, PDF or Word format............................................................................................................................... 49

User manual:
III Using the device
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.
XE_CTT_ME_AN_150319
III /1
User manual:
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 6-1-2-6: 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:
III /2 XE_CTT_ME_AN_150319
User manual:
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 / Chinese
XE_CTT_ME_AN_150319
III /3
User manual:
- The keyboard type selection:
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 IOL
Patient B Exam
Biometry Pachymetry
Activate USB video printer:

When activated, the option Print on USB video printer will be available in the examination screen
when the user will select the Print icon. The print will be able to adapt to the A6 format 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:
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:
Save all data:
This function allows the user to save all COMPACT TOUCH data on the unit hard disk or on an external
memory system.
NOTE:
For more details about archiving the COMPACT TOUCH database, please refer to:
COMPACT TOUCH User Manual: Chapter IV - Maintenance.
CAUTION:
It is recommended to perform a database backup on a regular basis as well as before any modification or
unit servicing.
Windows access:
Selecting this icon allows the user to use Windows functionalities.
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User manual:
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.
D2 (fixed and low dynamic at 20dB):

D1 (adjustable dynamic):
Markers are positioned on the rising edge of the
The markers are positioned at the top of the
echoes at the threshold level
echoes pics. Displayed Dynamic : 35dB
Displayed Dynamic : 20dB (more contrast)
User manual:
NOTE:
It is not advised to use D2 mode when using the Contact technique.
Other parameters:
25 to 90dB. Dynamic displayed by default in the Biometry scan image with D1 mode
Dyn D1
selected (Default value: 35dB)
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
TGC
dB.
(Default value: 10dB)
From 20 to 110dB. Default gain which will be used when starting the acquisition:
Default Gain
80dB. Default gain factory setting: 80 dB;
Mode Manual, Auto, Auto + Save
- Contact (Acquisition Technique in contact with cornea)
Technique
- Immersion (Using a water bath interface with a scleral shell)
Anterior chamber (AC): 1532 m/s by default
Lens (L): 1641 m/s by default
Velocities Dense/Long: 1641 m/s by default
Vitreous (V): 1532 m/s by default
Different implant materials for lens and vitreous may be entered.
This table may be used to enter new lens materials / or modify names with an
associated speed of propagation (m/s):
By default:
Lens Materials table
PMMA: 2718m/s
Acrylic: 1946m/s
Silicon: 1050m/s
Vitreous materials table this table is used to enter silicone oil propagation speeds in
case of silicone filled eyes.
Factory default parameters are:
Vitreous materials table Silicone 1000: 980 m/s
Silicone 5000: 1050 m/s
These parameters must be modified by the user according to the type of silicone oil
and its viscosity.
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User manual:
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.
User manual:
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).
CAUTION:
When recording Cineloop sequences in COMPACT TOUCH format, the backup size is very important.
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User manual:
4.2.3. Comments shortcuts list (B mode only)

The Comments Sortcuts list allows the user to quickly add recurring comments to the exams. Each
shortcut is associated with a comment:
With the tool icon selected, the list of available shortcuts is displayed at the bottom right of the
acquisition screen.
In all cases, those comments are displayed (printed) on the images (single image reports):

User manual:
4.2.4. 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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User manual:
4.2.5. 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

User manual:
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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User manual:
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
Pachymetry Correction Pachymetry (m) Correction (mmHg)

(m) (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
DRESDNER
Correction table
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

User manual:
DOUGHTY
Correction table
Pachymetry (m) Correction

(mmHg)
405 7
425 6
445 5
465 4
485 3
505 2
525 1
545 0
565 -1
585 -2
605 -3
625 -4
645 -5
665 -6
685 -7
705 -8
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:
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.
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.
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User manual:
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).

User manual:
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. Refraction data
When selecting , the following screen is diplayed:
The following refraction data information can be entered:

- Axis values for K1 and K2 (positive values ranging from 0 to 180 - by step of 1)
- Sphere value (from -40.00D to 20.00D by step of 0.01)
- Cylinder value (from -40.00D to 20.00D by step of 0.01)
- Cylinder axis value (positive values ranging from 0 to 180 - by step of 1)
NOTE
The refraction data are for information only: they are not used for calculation. Those values are displayed
in the IOL report.
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User manual:
5.3. 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:

User manual:
5.4. 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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User manual:
5.5. 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).
5.6. 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

User manual:
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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User manual:
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

- Bio Note:
Probe Selection - Probeam Select the correct probe or else
- B10 measurements will wrong
- Phakic
- Acrylic
- Aphakic
Eye Type - Silicone
- Dense/Long
- Others created by the user.
- PMMA
-Silicone 1000
Vitreous Type - Normal eye.
- Silicone 5000
- Manual
Mode - Auto + Save
- Auto
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)
Area 1
Area 2

User manual:
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
The selected result (result line, average or Stat 2) will be used for the
Result Choice
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

To export exams (Jpeg) with no name, nor patient ID. The exported
Anonymous file name and patient name in the image will be replaced by
Anonymous.
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.
To open a Save as window to export exam data file in native format
Hotline export to the HotlineExport folder. The file name is created by default but
can be modified by the user.
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User manual:
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).
AUTO MODE
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.

User manual:
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 In Automatic mode, in addition to the Retina Slope
threshold the echoes should reach for automatic Test, the presence of the scleral echo is expected. Its
acquisition. Moreover, the acquisition software has amplitude must be above the threshold. It is the case
also been designed to freeze the A-scan when the if the probe is aligned with the macula. If the scleral
probe direction is in the visual axis: i.e. the rising spike is not detected, the probe is aligned along the
edge of the retina should be as much perpendicular to optic nerve, which is not a correct position.
the base line as possible. To reach this goal, the Exception: in Dense/Long mode, the sclera
retinal spike sharpness criterion is tested. 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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User manual:
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 10 in the result table example).
If is selected from this screen, 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 #7
2.45+3.49=5.94mm
The shortest vitreous length: see lines #3: 17.12mm.
STAT-2=5.94+17.12=23.06mm
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.

User manual:
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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User manual:
The following screen with 4 IOLs results tables is displayed:
A. IOL selection
B. Formula selection
C. Post-operative ametropia
D. Increment
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

User manual:
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.
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.
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User manual:
6.1.3. Biometry guided by B-Mode (COMPACT TOUCH B and AB)

distributor for details on how to order this option and get an activation keycode .
To carry out this examination, the patient has to be lied down. The easiest location for the examiner is to
be behind the 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:
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 CV field and use the knob to modify the position of this CV line)

User manual:
The markers position can also be modified if necessary: refer to:

Section 6.1.2.1: Functions description.
Area 1
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.
NOTE:
Probe orientation can be Axial only (Longitudinal and Transversal icons are deactivated).
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:
Unfrozen image (during

State of acquisition Frozen image
acquisition)
Action on Short pressure Long pressure Short pressure Long pressure
footswitch (less than 1s) (more than 1s) (less than 1s) (more than 1s)
Unfreeze the Save
Manual Freeze image
image (even if result table is not filled)
Save
Auto+Save Unfreeze the
Inhibition of the (when result table is filled)
image (if the
No action automatic Include or ignore the results
result table is
Auto acquisition or
not filled)
Save (when result table is filled)
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)
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User manual:
6.2. B-Scan
distributor for details on how to order this option and get an activation keycode .
The 10 MHz B-scan probe is focused at about 25mm (to create images of the eye and orbit). It can be used
directly on the eyelid:
Place some gel on the lid
Place the probe on the eye
Ask the patient to look in different directions to reach certain zones on the globe
CAUTION:
Placing excessive pressure on the B-scan probe will cause discomfort to the patient.
6.2.1. Functions description

To display the acquisition screen for B mode, select:
Without Patient name With Patient name and recorded exams
Area 1
Area 2
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 :
When selecting the icon :

User manual:
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)
Those functions allow the user to specify the probe position during the
examination.
To select probe orientation, click on:

for for
for Axial
Longitudinal Transverse
When selected, the icon color turns orange and the probe is positioned on
the clock (time is displayed).
To select customized probe position around the clock, click on chosen
hour. To adjust to half hour, select:
NOTES
- Inform about probe position by selecting an hour on the clock after
unfreezing the probe for examination or before saving the exam.
Indeed, when the probe is activated, all settings disappear.
- Right clicking in the clock allows the user to switch probe
orientation from Longitudinal, to Transversal and then Axial.
Left click on the letters to select the anatomical location:
Ax, CB, O, EA, E, EP, PE or P
Ax: Axial
CB: Ciliary body
O: Ora serrate
EA: Equator towards anterior
E: Equator
EP: Equator towards posterior
PE: Posterior towards equator
P: Posterior
The selection is displayed inside the eye drawing ( as shown in the example
on the left hand side: Ax equator)
Left click on the orange letter to unselect the equator.
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
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User manual:
Functions description (next)

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.
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
This icon allows the user to display the Cineloop sequence
This icon allows the user to save the Cineloop sequence
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
Slow speed
Fast speed (sweeping Two transducer sweeping frequencies are available with the 10 MHz probe.
(sweeping
frequency = 16Hz): By default, the slow speed is selected
frequency = 9Hz):
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)
In case the wrong eye type was selected during examination: this button
allows the user to change eye selection on a saved exam: in this case, a
warning message is displayed to make sure the eye selection is changed
on purpose for error rectification. If the eye is changed: Longitudinal,
Transversal, Axial and equator parameters information is removed so that it
is necessary to select the correct parameters before saving.
Reports created with the wrong eye selection will automatically be deleted.
In case of IOLs calculations: they will have to be redone on the biometry
exam with corrected eye.
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

User manual:
Functions description (next)

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
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.
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User manual:
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:
Copy To copy the image in the clipboard of Windows
To export exams (Jpeg) with no name, nor patient ID. The
Anonymous exported file name and patient name in the image will be
replaced by Anonymous.
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.
To modify the background color of the image when the Cineloop is
Cineloop color
activated.
To open a Save as window to export exam data file in native
Hotline export format to the HotlineExport folder. The file name is created by
default but can be modified by the user.
By right clicking on the mouse on the miniature images of AREA 2, a menu appears with the following
choices:
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.
Allows the user to unselect all images that were previously added to the
Clear report
report.
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):
State of acquisition Unfrozen image (during acquisition) Frozen image
Short pressure (less Long pressure Short pressure (less Long pressure (more
Action on footswitch than 1s) (more than 1s) than 1s) than 1s)
Allows the user to Freeze image or acquisition Unfreeze the image Save
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

User manual:
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.
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:
It is possible to modify the ultrasounds speed of propagation for the calipers (tools):
double click in the speed field to adjust the value from 500m/s to 5000m/s ( the modified
speed value is then displayed in red).
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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User manual:
6.2.6.1. Caliper (To measure a distance)

To use the caliper function, select:
Place the pointer over the desired location on the

picture and left-click on the mouse to freeze its
position. Repeat this procedure to place the second
marker. The caliper reference C# is displayed for
each point:
The C# reference and corresponding

measurement are displayed in the tools result table.
Comments can be added in the comment field: click
and type in some text.
To move the caliper:
Left click on the caliper to be moved (the selected caliper will be highlighted in red).
Release the mouse button.
Move the mouse to reposition the caliper.
Left-click again to validate the new position.
6.2.6.2. Marker (To indicate a particular point on the image and give
comments)
To use the marker function, select:
Position the pointer by left-clicking to set the

front part of the arrow. Adjust the arrow
direction and left-click to validate final
position. The marker reference M# is
displayed next to the marker on the image.
The reference M# is displayed in the list of

the tools result table.
Comments can be added in the comment field:
click and type in some text.
To move a marker:
Left click on the marker to be moved (the selected marker will be highlighted in red).
Move the mouse to set the new marker position.

User manual:
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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User manual:
6.3. Pachymetry
distributor for details on how to order this option and get an activation keycode.
Remove the pachymetry probe from the probe holder. Clean the tip as indicated in chapter:
COMPACT TOUCH User Manual: Chapter I - Regulatory and safety information
Section 2-3 How to prevent a transfer of infection
The cornea has to be anesthetized. The probe has to be directly placed on the cornea. The tear film should
be sufficient to make contact for the ultrasound transmission.
NOTE:
If no acquisition is possible, drop some physiologic serum on the patient cornea.
CAUTION:
Be careful not to exert any pressure on patient cornea.
Select the icon:
The screen corresponding to the Acquisition Mode selected by default in the Pachymetry Setup screen
(accessible from the Physician Setup screen) appears. The acquisition mode can be selected among the
dropping list which follows:
The following menu is displayed at the bottom of the pachymetry screens:
Functions description:
OD / OS Eye selection (by default OD is displayed when creating a new patient)

Erase All Erase all the measured values
Switch to the acquisition mode (Center Only, Automatic, Continuous,
Acquisition mode
then Scanning)
Freeze Select a type of freeze (easy, medium or hard)
To start the pachymetry acquisition, press the footswitch or the following icon:

User manual:
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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User manual:
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).

User manual:
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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User manual:
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.

User manual:
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 Print on USB Video printer
then Print:
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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User manual:
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.

User manual:
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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User manual:
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)

User manual:
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:
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.
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.
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User Manual:
IV - Maintenance
MARCH 2015
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2008
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

User manual:
IV Maintenance
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.
XE_CTT_ME_AN_150319 IV /1
User manual:
IV Maintenance
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):
OR
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:
IV /2 XE_CTT_ME_AN_150319
User manual:
IV Maintenance
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:
The Best is not comprised

between:
10.00 < Best < 10.11 mm
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:
User manual:
IV Maintenance
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 Setu p 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.
IV /4 XE_CTT_ME_AN_150319
User manual:
IV Maintenance
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:
MARCH 2015
FRANCE
Tel. : +33 (0) 473 745 745
Fax : +33 (0) 473 745 700
2008
Directive 93/42/EEC
CONTENTS
1. IOL FORMULAE .................................................................................................................................................. 1
1.1. USED VARIABLES ................................................................................................................................. 1
1.2. S.R.K.-II.................................................................................................................................................... 1
1.3. S.R.K.- T ................................................................................................................................................... 2
1.4. DOUBLE K / SRK-T (FROM DR JAIME ARAMBERRI) ............................................................... 3
1.5. BINKHORST II ........................................................................................................................................ 4
1.6. HOLLADAY .............................................................................................................................................. 5
1.7. HOFFER-Q................................................................................................................................................ 6
1.8. SHAMMAS ............................................................................................................................................. 7
1.9. HAIGIS ................................................................................................................................................... 8*
2. IOL CALCULATION FOR POST REFRACTIVE SURGERY ........................................................................... 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*
User manual:
V Appendix IOL formulae
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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User manual:
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
(1336 x S3 IOL x S1 x S2)

REF_X =
(1.336 x S4 0,001 x IOL x S1 x S5)
[1336 x (S3 0.001 x REFt x S4)]

IOL_FOR_TGT =
[S1 x (S2 0.001 x REFt x S5)]
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User manual:
1.4. Double K / SRK-T (From Dr Jaime Aramberri)

Correction Axial Length: Lcor
Lcor = AL except if AL > 24.2 Lcor = -3.446 + (1.716 x AL) - (0.0237 x 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
1336 x S3
IOL emme =
(S1 x S2 )
(1336 x S3 IOL x S1 x S2)

REF_X =
(1.336 x S4 0,001 x IOL x S1 x S5)
[1336 x (S3 0.001 x REFt x S4)]

IOL_FOR_TGT =
[S1 x (S2 0.001 x REFt x S5)]
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User manual:
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)
1336 [ 1.336R 0.3333Lb 0.001Ref (16,032R 4Lb + Lb. R) ]

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

Ref =
1.336(16.032R 4Lb + LbR) 0.001IOL(Lb AC) (16.032R 4AC + AC. R)
XE_CTT_ME_AN_150319
V /4
User manual:
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)
1336 [1.336. R 0.3333Lh 0.001Ref (16.032R 4Lh + Lh. R) ]

IOLam =
(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)
1336 (1.336R 0.3333Lh) IOLam(Lh ACh)(1.336R 0.3333ACh)

Ref =
1.336 (16.032R 4Lh + Lh. R) 0.001 IOLam (Lh ACh)(16.032R 4ACh + ACh. R)
XE_CTT_ME_AN_150319
V /5
User manual:
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)
1.336
R=[ ]
[1.336 / (1336 / (AL CD 0.05) IOLam) + (CD + 0.05) / 1000]
Rx = R / (1 + 0.012R)
XE_CTT_ME_AN_150319
V /6
User manual:
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
1336 1
IOLemm =
L 0.1(L 23) C 0.05 1.0125 C + 0.05

K 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)
1336 1
IOLAm =
L 0.1(L 23) C 0.05 1.0125 C + 0.05

K+R 1336
FORMULA TO CALCULATE THE REFRACTION CORRESPONDING TO THE IOL VALUE:
Refr. = Vs (IOL)
1336 IOL (L 0.1(L 23) C 0.05)

R =
L 0.1(L 23) (IOL (C + 0.05) (L 0.1(L 23) C 0.05)

1.0125 1352.7
XE_CTT_ME_AN_150319
V /7
User manual:
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":

n - n
Dl =
L-d n -d
z
(1)
With:
Rx
z = Dc +
1 - Rx . dx
(2)
Where:
Nc - 1
Dc =
R
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:
q - Dc
Rx =
1+ dx . (q + Dc)
(3)
Where:
n . [n - Dl . (L - d)]
q=
n . (L - d) + d . [n - Dl . (L - d)]
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.
XE_CTT_ME_AN_150319
V /8
User manual:
4. IOL constants a0, a1, a2:

In standard or default mode, the constants a0, a1 and a2 are given by:
a1 = 0.400
a2 = 0.100
a0=0.62467 x A 72.434 (6)
with A: Lens constant provided by the manufacturer.
In optimized mode, the constants a0, a1 and a2 are obtained by a separate optimization process. For
each patient, the actual post-op refraction is used to calculate the corresponding optical ACD. For all
patients, these values are then correlated with the pre-op ultrasound measurements of the (acoustical)
ACD and the axial length. Double linear regression analysis yields the constants a0, a1 and a2.
Global limitations: -2 < a0 + 3.37a1 + 23.39a2 < 12

-2 < a0 + 2.53a1 + 20.00a2 < 12
-2 < a0 + 3.50a1 + 27.00a2 < 12
5. Examples:
A-constant A=118.0
> a0 = 1.277; a1 = 0.400; a2 = 0.100;
1) L = 21.44; AC = 2.69; R = 7.45;

target refr. Rx= -0.250
> d = 4.497; DL= 26.862
2) L = 23.27; AC = 3.14; R = 7.69;

IOL implanted DL= 22.000
> d = 4.860; Rx= -0.398
3) L=27.09; AC = 3.48; R = 7.76;

target refr. Rx = 2.730
> d = 5.378; DL= 5.768
6. Copyright notice:
This description is by W.Haigis, 1998-2000. It may not be used for publication, neither in total nor in
parts, without the written consent of the author.
Wrzburg, Jan.25th , 2000; Dr.W.Haigis
XE_CTT_ME_AN_150319
V /9
User manual:
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:
Pre-op Keratometry
Keratometry information:
Or actual Keratometry only
Pre-op & post-op Refraction
Refraction information:
Or post-op Refraction only
Historical Data is No Historical Data is

known known
Refraction with
Only Pre-op Current K Contact Lens
Pre-op Refraction Measurement
Keratometry
Pre-op
Refraction KS
Kcl
Current K TL Measurement SHAMMAS
Measurement Contact Lens
Khd
History
derived Krd KR IOL
IOL
Refraction ROSA SHAMMAS
All
derived formulae
IOL
IOL IOL
IOL SRK-T
All Double
K/SRK-T All SRK-II if
formulae
formulae TL>29.4mm
Available methods & formulae when historical patient

Available methods & formulae when historical patient data is NOT known.
data is 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.
XE_CTT_ME_AN_150319
V /10
User manual:
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) =7.94D
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:

The formulae: SRK-T; Holladay; Hoffer-Q calculate the Effective Lens Position (ELP) from the keratometry
value. The refractive surgery is not modifying the natural anterior chamber of the eye, so the ELP
calculated with a post-op K will be incorrect and underestimated. Hoffer-Q usually gives a stronger
value. To solve this issue: the Double K / SRK-T formula from Dr. Aramberri applies the SRK-T formula
using both keratometry values:
The pre-op K for the Effective Lens Position
The history-derived post-op K value for the final IOL power.
XE_CTT_ME_AN_150319
V /11
User manual:
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:
XE_CTT_ME_AN_150319
V /12
User manual:
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
KR = 337,5 / 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.
XE_CTT_ME_AN_150319
V /13
User manual:
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.
XE_CTT_ME_AN_150319
V /14

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COMPACT TOUCH USER MANUAL

QUANTEL MEDICAL QUANTEL USA MEDICAL UNIT

2015 QUANTEL MEDICAL

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

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

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

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

A scan echography for axial length measurement(option*)

The device can be delivered with the following configurations:

COMPACT TOUCH A: with A probe only

An optional pachymetry probe can be delivered with all configurations:

2. USER MANUAL DESCRIPTION

3. USER MANUAL TERMS AND SAFETY SYMBOLS

4. UNPACKING THE INSTRUMENT

COMPACT TOUCH A (XECTTA):

COMPACT TOUCH B (XECTTB):

COMPACT TOUCH AB (XECTTAB):

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

1. INTENDED USE AND CONTRAINDICATIONS

2. SAFETY INFORMATION AND PRECAUTIONS

2.2. Probes care / WARNINGS and CAUTIONS

2.3. How to prevent a transfer of infection

2.3.2. Pre-disinfection and disinfection procedures / USA only

How to Disinfect Immersion Scleral Shells

2.3.3. Finger cots

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

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

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

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

Do not dispose with domestic household

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

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

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

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

Identification label information:

Ref. Labels & Description

Protection against electrical shocks: the applied parts are classified as