Lumibird Quantel ABSOLU User manual

Ultrasound Platform
SERVICE MANUAL
FEBRUARY 2020 A/S/B Scan & UBM
11, rue du bois joli - CS 40015
63808 Cournon d’Auvergne Cedex
FRANCE
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web site: www.quantel-medical.com

This QUANTEL MEDICAL equipment, including the associated software and documentation
are proprietary products of QUANTEL MEDICAL under international copyright law and all
rights are reserved. This manual may only be reproduced in whole or in part with written
permission of QUANTEL MEDICAL. This manual is furnished for informational use only and
QUANTEL MEDICAL reserves the right to modify the equipment characteristics and manual
without previous notice. Photos and diagrams are not contractual. QUANTEL MEDICAL
cannot be held responsible for any damage or injury which results from a failure to follow,
or incorrect use of, the instructions contained in this manual. The guarantee of the
equipment will be void if the equipment is opened (even partially), modified or repaired in
any way by persons who are not authorized by QUANTEL MEDICAL.
Any question regarding the installation or the use of the ABSOLU system should be directed
to the QUANTEL MEDICAL Service Department or to a local distributor:
International
QUANTEL MEDICAL
11, rue du bois joli,
63808 Cournon d’Auvergne
FRANCE
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web site: www.quantel-medical.com
U.S.A.
QUANTEL MEDICAL USA
2313 Ridge Road Suite 105A
75087 Rockwall, TX
USA
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Web site: www.quantel-medical.com
Poland
QUANTEL MEDICAL POLSKA
ul. Raclawicka 93
02-634 Warszawa
POLAND
Tel: [phone]
E-mail: [e-mail]
Web site: www.quantel-medical.pl
© 2020 QUANTEL MEDICAL
All rights reserved
ABSOLU Service Manual
Software Version 1.03 and over
International version
(Ref: XE_ABS_MT_AN)
February 24, 2020

CONTENTS REV 24/02/2020
1. INTRODUCTION......................................................................................................................................1
2. USER MANUAL TERMS AND SAFETY SYMBOLS ...............................................................................1
3. WARNINGS & CAUTIONS......................................................................................................................1
3.1. Servicing the unit warning & cautions.............................................................................1
3.2. Using the unit: warnings and cautions ............................................................................2
3.3. Probes: warnings and cautions..........................................................................................3
3.4. Precautions to take concerning wastes and elimination of device and
accessories..............................................................................................................................4
4. ABSOLU TECHNICAL SPECIFICATIONS ..............................................................................................5
4.1. Classification ..........................................................................................................................5
4.2. Electrical requirements .......................................................................................................5
4.3. Compliance .............................................................................................................................5
4.4. Dimensions..............................................................................................................................6
4.5. Environmental conditions...................................................................................................6
4.6. ABSOLU computer system specifications........................................................................6
5. ULTRASOUND SYSTEM PROBES SPECIFICATIONS..........................................................................7
5.1. Standardized A probe...........................................................................................................7
5.2. Biometry probe......................................................................................................................7
5.3. 15 MHZ B-SCAN probe...........................................................................................................7
5.4. 20 MHZ Annular B-SCAN probe (option) ..........................................................................8
5.5. 50 MHZ Linear probe.............................................................................................................8
6. BLOCK DIAGRAM .................................................................................................................................. 9
7. MAIN UNIT AND ACCESSORIES ........................................................................................................ 10
7.1. Main units, probes and options.......................................................................................10
7.2. Accessories and consumables ......................................................................................... 11
7.3. Spare parts............................................................................................................................11
7.4. Footswitch .............................................................................................................................12
8. DISASSEMBLING THE UNIT TO REPLACE DEFECTIVE SPARE PARTS..........................................13
8.1. Removing the back cover ..................................................................................................13
8.2. Accessing subsystem boards............................................................................................13
8.2.1. Replace the A-15-50 ERM board with a S-15-50 ERM board....................14
8.3. Remove the screen from the base of the device ........................................................15
8.4. Open the screen...................................................................................................................16
9. ABSOLU DEVICE DISPLAY –Adjust magnifier tool......................................................................19
10. PROBES MANAGEMENT AND CALIBRATION ..................................................................................20
10.1. Standardized (A-Std) / regular biometry (A) probe................................................... 20
10.1.1. Adding or removing a standardized / regular biometry probe &
calibration .......................................................................................................... 20
10.1.2. Delete or add a new standardized or regular biometry probe............. 20
10.1.3. Tissue sensitivity determination for A-Std type of probe (only
when S mode is activated) ..............................................................................21
10.1.4.Measurement test regular biometry probe calibration...........................22
10.1.5. Measurement test regular biometry probe calibration...........................25
10.2.Adding / suppressing other probes (B15, B20-5A and LIN50MHz) ..........................26
10.3.Linear probe calibration check........................................................................................27
10.3.1. Calibration tool ..................................................................................................27
10.3.2.Calibration setup ...............................................................................................27

10.3.3.Calibration procedure ..................................................................................... 28
10.4.Check the image of the rings (only B20-5A)................................................................. 30
10.5.Solving noise problems (with B and Linear probes in acquisition mode)............32
10.6.Probes care ...........................................................................................................................33
11. DATABASE MANAGEMENT................................................................................................................. 34
11.1. Data information .................................................................................................................34
11.2. Saving the database ...........................................................................................................34
11.2.1. Procedure to save only the database (without data)...............................34
11.2.2. Procedure to save only data: images, Cineloop… (without database).35
11.2.3. Procedure to save all data (database + data: images, Cineloop…).......35
11.3. Database factory installation...........................................................................................35
11.3.1. Procedure to install the database factory..................................................36
11.3.2. Calibration of the “A-Bio” and “A-ProBeam” probes............................... 40
11.4. Transfer database from Master ABSolu to Destination ABSolu.............................. 40
11.4.1. Backup of the Master ABSolu......................................................................... 40
11.4.2. Install the Master ABSolu database in the Destination
ABSolu software.................................................................................................41
11.4.3. Calibration of the “A-Bio” and “A-ProBeam” probes................................45
12. UPDATE SOFTWARE ...........................................................................................................................46
12.1. Procedure to install the new software.......................................................................... 46
13. UPGRADE OF THE INTEL GRAPHICS DRIVER .................................................................................48
13.1. Checking of the Intel HD Graphics 520 driver version .............................................. 48
13.2. Installation of the recommended driver version....................................................... 49
13.3. Suspend automatic update...............................................................................................52
14. INSTALLATION OF COBIAN APPLICATION...................................................................................... 53
15. ABSOLU SETUP ....................................................................................................................................57
15.1. “Retina Slope Test” .............................................................................................................57
15.2. Contact us message........................................................................................................... 58
15.3. Activate threshold line for LESION Q-I.......................................................................... 58
15.4. Activate Axial Length ..........................................................................................................59
16. HIPAA COMPLIANCE...........................................................................................................................60
16.1. Security awareness and training.................................................................................... 60
16.2. Contingency plan.................................................................................................................61
16.3. Access control ......................................................................................................................61
16.4.Audit controls.......................................................................................................................62
16.5. Integrity..................................................................................................................................62
16.6.Person of entity authentication.......................................................................................62
16.7. Transmission security ........................................................................................................63

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1. INTRODUCTION
This service manual gives ABSOLU technical information such as:
The technical specifications
The accessories and spare parts
Disassembling the unit and connectors pin description
Probes management and calibration
Database management
Servicing the unit
2. 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
3. WARNINGS & CAUTIONS
3.1.Servicing the unit warning & cautions
WARNINGS
Warranty will be void unless the following recommendations are strictly respected:
oAny adjustment and calibration procedure described in this manual shall be performed
by QUANTEL MEDICAL authorized technicians only or by personnel who has been
previously trained by QUANTEL MEDICAL.
oAny faulty part should/will be replaced by a strictly identical one provided by QUANTEL
MEDICAL.
oFor safety reasons, QUANTEL MEDICAL considers any electronic board as a whole partial
assembly:
- Defective boards must be returned to QUANTEL MEDICAL for replacement.
- Warranty will be void if a board has been damaged during servicing or an attempt
to repair.
A special training delivered by QUANTEL MEDICAL is required for any technicians prior to
perform maintenance on the equipment to ensure optimum adjustments and maximum
instrument reliability.
CAUTION
Before performing any maintenance or repair on the equipment, ensure that all the
database, as well as the system/user configuration and parameters have been saved in order
to restore them afterwards if needed.

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3.2.Using the unit: warnings and cautions
Tissue exposure to ultrasound energy: the ABSOLU unit is designed for use in ophthalmology
only. While QUANTEL MEDICAL is not aware of any reports of adverse effects from using
ophthalmologic ultrasound unit, even at FDA pre-enactment levels, no other use is intended
or implied. The system controls limit the output energy to within the parameters specified
for its intended purpose. No control of ultrasound energy is available to the user other than
the duration of exposure.
WARNINGS
USA Federal Law requires that this device be sold only by on the prescription of a physician.
This device is not intended for foetal use.
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 ABSOLU 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:
ABSOLU User Manual: II- Technical information
Section 5 –Installation: technical information
Do not modify the equipment (ABSOLU provided by QUANTEL MEDICAL) without authorization
of the manufacturer.
In case the equipment (ABSOLU provided by QUANTEL MEDICAL) 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 equipment has to be disconnected from the telecom, IT network and/or USB accessories
during examination, if the connected accessories are not separated with a network isolator
and/or USB isolator (that comply with IEC 60601-1 and IEC 60950 standards, moreover the
installation of accessories / isolators have to be performed or checked by the responsible
organizations: clause 16 IEC 60601-1, third edition).
Only use a network device or USB accessories that comply with IEC 60601-1 and IEC 60950
standards.
Each time 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 organizations with the new equipment installation: clause 16
IEC 60601-1, third edition.
Do not use flammable anesthetics product.
Do not use in oxygen rich atmosphere.
Some persons are extremely allergic to isopropyl alcohol.

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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 device, as it may compromise the
ABSOLU software. Installing non-QUANTEL MEDICAL software will cause the warranty to be
void. QUANTEL MEDICAL is not responsible for any errors caused by adding programs to the
computer’s hard drive.
Do not connect the ABSOLU to the Internet: the ABSOLU 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 ABSOLU to the INTERNET.
The installation of an antivirus may use computer resources that are necessary to the normal
functioning of the ABSOLU device and thus reduce the system performances. The image
acquisition in real time by the ABSOLU 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 ABSOLU system (especially concerning the image acquisition).
3.3.Probes: 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.
The probes must be cleaned to prevent cross contamination. QUANTEL MEDICAL recommends
a cleaning procedure:
oFor the biometry 15MHz and 20-5AMHz probes: refer to:
ABSOLU User Manual: I- Regulatory and safety information
Section 2.3: How to prevent a transfer of infection
oFor the LIN 50 probes: refer to the documentation provided with the linear probe case:
Procedure for Linear 50MHz probes:
Preparation - Cleaning and disinfection - Usability
(Documentation code XE_LIN50_NI_ANFR)
15MHz, B20-5AMHz and 50MHz probes should regularly be checked at least once a week:
oCheck the probe body and cord aspect to detect any damage that may alter the probe’s
performance.
oConcerning LIN 50 probes, if any air bubble is detected: fill in the probe with distilled
water.
Systematically check the probe calibration if it used for sizing.
CAUTIONS
The probes should never be autoclaved or subjected to excessive heat.
The probes are fragile and must be handled with care. They will be damaged if dropped onto
a hard surface.
The Lin 50 MHz probe transducer is very fragile: do not touch it!
Do not use any abrasive cleaning products or solvents that may alter the probe’s body
aspect. If possible, clean off stains immediately.