AVISO User Manual: Introduction - ugap.fr ... USER MANUAL TERMS AND SAFETY SYMBOLS ... • Any adjustment and calibration procedure described in this manual shall be performed by QUANTEL

September 2015

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 AVISO & S 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. : +33 (0) 473 745 745 Fax : +33 (0) 473 745 700 E-mail : [email protected] Web site: www.quantel-medical.com

U.S.A. QUANTEL USA MEDICAL UNIT 601, Haggerty Lane BOZEMAN MT 59715 U.S.A. Tel : +1 888 660 6726 Fax : +1 (406) 586 2924 E-mail : [email protected] Web site www.quantel-medical.com

© 2015 QUANTEL MEDICAL. All rights reserved. AVISO & AVISO S Service Manual International version (Ref: XE_AVIAVISTD_MT_AN) September 21st, 2015

CONTENTS REV* 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. AVISO & S TECHNICAL SPECIFICATIONS ....................................................................................... 4

4.1. Classification ........................................................................................................................ 4

4.2. Electrical requirements ................................................................................................................... 4

4.3. Compliance ........................................................................................................................ 5

4.4. Dimensions ........................................................................................................................ 5

4.5. Environmental conditions ................................................................................................................ 5

4.6. Computer minimum requirement ....................................................................................................... 6

5. ULTRASOUND SYSTEM PROBES SPECIFICATIONS ........................................................................... 7

5.1. Standardized A probe (uni-directional) ............................................................................................... 7

5.2. “Regular” biometry probe................................................................................................................ 7

5.3. 10 MHZ B-SCAN Probe ....................................................................................................................................................7

5.4. 20 MHZ B-SCAN Probe ................................................................................................................... 7

5.5. Linear Probes ........................................................................................................................ 8

6. BLOCK DIAGRAM ..................................................................................................................... 8

7. MAIN UNIT AND ACCESSORIES .................................................................................................. 9

7.1. Mains units, probes and options ....................................................................................................... 9

7.2. Accessories and consumables .......................................................................................................... 9

7.3. Spare parts ...................................................................................................................... 10

8. DISASSEMBLING THE UNIT TO REPLACE DEFECTIVE SPARE PARTS .................................................. 11

8.1. Removing the main cover .............................................................................................................. 11

8.2. Accessing subsystem boards ......................................................................................................... 13

8.2.1. Removing the interface board (XEAVIERMPCB / XEAVISERMPCB) ...................................... 13

8.2.2. Removing the power supply board (XECT2POW) ............................................................. 14

8.2.3. Removing the CPU board (XEAVICPUPCB) ..................................................................... 14

8.2.4. Removing the screen (XLVITECRAN) + touch screen (XLVITDALLE) assembly ......................... 15

9. TOUCH SCREEN CALIBRATION .................................................................................................. 16

10. AVISO / AVISO S COMPUTER DISPLAY ........................................................................................ 17

10.1. AVISO / AVISO S COMPUTER SCREEN CALIBRATION CHECK ........................................................... 17

10.2. AVISO / AVISO S COMPUTER ADJUSTMENTS TO BE DONE FOR WINDOWS® EIGHT (8.1 VERSION) ........ 18

10.2.1. Navigation properties setup with Windows® Eight (8.1 version)........................................ 18

10.2.2. Adjust magnifier tool ............................................................................................... 19

11. PROBES MANAGEMENT AND CALIBRATION ................................................................................ 20

11.1. Standardized (A-Std) / regular biometry (A) probe .......................................................................... 20

11.1.1. Adding or removing a standardized / regular biometry probe & calibration ........................... 20

11.1.2. Delete or add a new standardized or regular biometry probe ............................................. 20

11.1.3. Tissue sensitivity determination for A-Std type of probe (AVISO S only) ............................... 21

11.1.4. Measurement test / standardized or regular biometry probe calibration............................... 22

11.2. Adding / suppressing other probes (B10, HFP, LIN 25MHz and LIN 50MHz) .......................................... 24

11.3. Linear probe calibration check ................................................................................................... 25

11.3.1. Calibration tool ....................................................................................................... 25

11.3.2. Calibration setup ..................................................................................................... 25

11.3.3. Calibration procedure ............................................................................................... 26

11.3.4. Solving noise problems (with Lin 50 MHz acquisition mode) .............................................. 28

11.4. Probes care ........................................................................................................................... 28

12. AVISO / AVISO S SOFTWARE COMPATIBILITIES ...................................................................................... 29

12.1. Software Version versus Operating System compatibilities .............................................................. 29

12.2. Software upgrade & compatibilities ........................................................................................... 30*

12.3. AVISO / AVISO S software version 5.XX: module and probe parameters compatibilities ......................... 31

13. DATABASE MANAGEMENT ...................................................................................................... 32

13.1. Database information ............................................................................................................. 32*

13.2. Database location ................................................................................................................... 33

13.3. Saving the database ................................................................................................................ 34

13.4. Where to re-install the database after upgrading the OS ................................................................. 35

13.5. AVISO / AVISO S software installation & data transfer from a computer 32-bits to a computer 64-bits ..... 38*

13.6. AVISO / AVISO S database “behavior” when choosing folder for installation ....................................... 45

13.7. AVISO / AVISO S database “behavior” / with several Windows sessions ............................................ 46

13.7.1. Database behavior with Windows Seven Operating System ................................................... 46

13.7.2. Database behavior with Windows Eight Operating System .................................................... 47

13.8. Suppressing the access to switch “User Account”.......................................................................... 48

14. AVISO / AVISO S SETUP .................................................................................................................. 48

15. MODULE SOFTWARE RELEASE .................................................................................................. 52

16. HIPAA compliance .................................................................................................................. 56

17. FUSE REPLACEMENT ............................................................................................................... 61

AVISO & S Service manual

XE_AVIAVISTD_MT_AN_150921

1. INTRODUCTION This service manual gives AVISO and AVISO S technical information such as:

- The technical specifications - The accessories and spare parts - Disassembling the unit and connectors pin description - Touch screen / Computer screen calibration - Probes management and calibration - Archiving database - 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

o Warranty will be void unless the following recommendations are strictly respected: · Any 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.

· Any faulty part should/will be replaced by a strictly identical one provided by QUANTEL MEDICAL. · For 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.

o 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.



3.2. Using the unit: warnings and cautions Tissue exposure to ultrasound energy: the AVISO & S unit is designed for use in ophthalmology only. While QUANTEL MEDICAL is not aware of any reports of adverse effects from using ophthalmologic ultrasound biometry, even at FDA pre-enactment levels, no other use is intended or implied. The system controls limit the output energy to within the parameters specified for its intended purpose. No control of ultrasound energy is available to the user other than the duration of exposure.

WARNINGS

· USA Federal Law requires that this device be sold only by on the prescription of a physician. · This device is not intended for foetal use. · 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 AVISO & S 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:

AVISO User Manual: II- Technical information Paragraph 4.3.Rear Connections

· Do not modify the equipment (AVISO & S + Computer provided by QUANTEL MEDICAL) without authorization of the manufacturer.

· In case the equipment (AVISO & S + Computer 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 computer has to be disconnected from the telecom, IT network and/or USB accessories during examination (except AVISO & S module), 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 computer, 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.

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 computer, as it may compromise the AVISO & S 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 AVISO & S computer to the Internet: the AVISO & S computer 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 AVISO & S computer to the INTERNET.

· The installation of an antivirus may use computer resources that are necessary to the normal functioning of the AVISO & S unit and thus reduce the system performances. The image acquisition in real time by the AVISO & S 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 AVISO & S system (especially concerning the image acquisition).

· Install a computer with the minimum configuration as specified in the: Paragraph 4.6: Computer minimum requirement

· The AVISO & S software is designed to provide the optimum information flow and performances if used with the adequate computer specifications and operating system as indicated in the: Paragraph 4.6: Computer minimum requirement If not, the AVISO & S software may not offer the optimum results.

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:

o For the biometry 10MHz, 20MHz and LIN 25MHz probes: refer to: AVISO User Manual: I- Regulatory and safety information Section 2.3: How to prevent a transfer of infection

o For 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 LIN 50 NI AN-FR)

· 10MHz, 20MHz B-scan, 25MHz and 50MHz Linear probes should regularly be checked at least once a week:

o Check the probe body and cord aspect to detect any damage that may alter the probe’s performance. o Concerning LIN 50 probes, if any air bubble is detected: fill in the probe with distilled water.

· The Lin 50 MHz probe transducer is very fragile: do not touch it! · 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.



3.4. Precautions to take concerning wastes and elimination of device and accessories:

Product category: This product complies with the WEEE Directive (2012/19/UE) marking requirements. The AVISO & S is an electrical / electronic product and must not be discarded with domestic household waste

Do not dispose with domestic household wastes!

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.

4. AVISO & S TECHNICAL SPECIFICATIONS

4.1. Classification The system is intended for continuous operation and has the following classification:

Electric security class EN 60 601-1 Standard Protective class I Type B Protection degree IP20 (protection from solid substances: diameter >

12,5mm)

4.2. Electrical requirements Power supply 100-120/200-240V ac

±10% single-phase Power supply specifications EOS V Series

Model Number MLVT40-3200 Frequency 50 / 60 Hz Maximum power consomption 25 VA maximum

WARNINGS

· Only mount/use on the AVISO & S module the power supply bloc approved by QUANTEL MEDICAL (please refer to the table above for specifications details).

· Only use the power supply module delivered with the computer. · To avoid any risk of electric shock, this equipment must only be connected to supply mains with

protective earth.



4.3. Compliance Power supply IEC 60 601-1

European Directive 93/42/CEE Electromagnetic compatibility IEC 60 601-1-2

WARNING Precautions to take with other devices using power supplies (other than those provided for the AVISO & S): AVISO & S conforms to IEC standard 60 601-1 (electric compatibility). All the other devices used in conjunction with the AVISO & S must be conformed to this standard.

CAUTION:

Precautions to take to avoid electromagnetic interferences with other devices: AVISO & S conforms to IEC standard 60 601-1-2 (electromagnetic compatibility). Make sure that all other devices used in the same room are in accordance with this standard.

4.4. Dimensions Global size Width: 17 cm (6.69 in)

Depth: 18,8 cm (7.40 in) Height: 19 cm (7.48 in)

User interface touch screen 8,6 x 11,5 cm (3.39 x 4.53 in)

4.5. Environmental conditions The temperature of the room where the device is operated must be within the following range: 10 °C < T° < 35 °C (50°F < T° < 95°F) The relative humidity must not exceed 95% without condensation The Device storage and transportation temperature must be within the following range: -20 °C < T° < 70 °C (- 4°F < T° < 158°F) Maximum operating altitude: 2000m (about 7000 ft).



4.6. Computer minimum requirement

Processor Intel® Pentium® IV Processor 2 GHz or higher Intel® Pentium® Centrino® Processor 1,6 GHz or higher Intel® Core2 Duo® Processor 1,8 GHz or higher AMD® Athlon®, Athlon Fx® , Athlon 64®, Athlon 64 X2® 2000+ or higher

Screen format Minimum resolution desktop: 1680 x 1050 (WSXGA+) Minimum resolution laptop: 1680 x 1050 (WSXGA+) 16/9 or 16/10 format screen is recommended. (5/4 format screen is not recommended) Do not use the WXGA (1440x900) format. This format is not compatible some functions of the AVISO software will not be displayed: cross vector function, category…

Recommended monitors 15.4" WUXGA+ (1920 x 1200) or (1320 x 1080) 20" WSXGA+ (1680 x 1050)

Operating system Microsoft® Windows® Seven (32 bits) Microsoft® Windows® Seven (64 bits) Microsoft® Windows® Eight (64 bits): 8.1 version (this version is required to display the AVISO application (desktop) by default upon startup)

Memory Minimum 2Go DDR SDRAM (4Go DDR SDRAM recommended) Graphics card 128MB RAM hardware compatible with DIRECTX® 9.0 (pixel shalder version 2.0) or

higher Example of compatible graphics card: NVIDIA® GeForce® 6600 or higher and NVIDIA® QuadroFX® ATI® Radeon® 9600 or higher (“X” letter corresponding to 10. Example ATI® Radeon® X300 corresponding to ATI® Radeon® 10300) Integrated graphics chipset or memory shared graphic card are not compatible with our software for the moment (by example Intel® graphics)

Boot hard drives 60Go ATA-100 IDE (5,400 tpm) minimum Computer and peripherals 3 USB 2.0 minimum. The computer has to be in conformity with the IEC 60950

standard / the peripherals connected to the computer also have to be in conformity with the IEC 60950 standard.

WARNINGS - To upgrade the system and/or for computer replacement and/or for Windows settings (such as UAC and

administrator rights): contact QUANTEL MEDICAL Service Department or your local distributor. - It is not possible to upgrade the AVISO software from a computer with an architecture of 32 bits to a

computer with an architecture of 64 bits. - The upgrade from AVISO to AVISO S is impossible. (et vice versa)



5. ULTRASOUND SYSTEM PROBES SPECIFICATIONS

5.1. Standardized A probe (uni-directional) Probe Reference STD-A Frequency 8 MHz Focal Length Non focused Emission running mode Pulsed Emission repetition rate 67 Hz Axial resolution 0.2 mm (at - 6dB)

5.2. “Regular” biometry probe Probe Reference TP-01 / TP-01-b (Tono-Probe) or TP-02-las (ProBeam) Frequency 11 MHz Focal Length 20 to 25 mm Emission running mode Pulsed Emission Repetition Rate 67 Hz Axial resolution 0.15 m (at - 6dB)

5.3. 10 MHZ B-SCAN Probe This type of probe is permanently sealed and leak-proof.

Probe Reference B1 Sector angle 50° Frequency 10 MHz Emission-running mode Pulsed Emission Repetition Rate 3939 Hz Focal length 21mm to 25mm Axial resolution 0.15mm (at -6dB) Lateral resolution 0.30mm (at -6dB)

5.4. 20 MHZ B-SCAN Probe This type of probe is permanently sealed and leak-proof.

Probe Reference B-HF Sector angle 50° Frequency 20 MHz Emission-running mode Pulsed Emission Repetition Rate 3939Hz Focal length 24mm to 26mm Axial resolution 0.1mm (at -6dB) Lateral resolution 0.25mm (at -6dB)



5.5. Linear Probes The LIN 25MHz type of probe is permanently sealed and leak-proof. The LIN 50MHz probe is an open probe.

Specification for: Linear 25 MHz Linear 50 MHz: Probe Reference LIN25 LIN50 Scanning amplitude 16mm 16mm Frequency 25 MHz 50 MHz Emission Repetition Rate 3413Hz 3413Hz Focal length 9mm to 11mm

(transducer) 9mm to 11mm (transducer)

Axial resolution 70 µm 35 µm Lateral resolution 120 µm 60 µm

6. BLOCK DIAGRAM



7. MAIN UNIT AND ACCESSORIES 7.1. Mains units, probes and options

CODE ITEM

MAIN UNITS

XEAVISO AVISO Console including USB and Power Cord, Probe Holder with Test Block, Footswitch, Tube of Gel, Clinical Echography of the Eye and Orbit Monograph, Installation Software and User Manual

XEAVISOS

AVISO S including 10 MHz B probe, Standardized A-scan Probe, Tissue Model, Footswitch, USB and Power Cord, Probe Holder with Test Block, Tube of Gel, Clinical Echography of the Eye and Orbit Monograph, Installation Software and User Manual

PROBES XEBSSPRBS Standardized Probe / Including parameters USB key XEPRBBIOPC Biometry Probe / Including parameters USB key XEPRBBIOLPC ProBeam™ - Biometry Probe with Laser Aiming Beam / Including parameters USB key XEPRB10PC2 10 MHz B Probe / Including parameters USB key and Finger Grip Sleeve XEPRB20FLPC2 20 MHz Probe for Posterior Pole / Including Probe Holder, parameters USB key and Finger Grip Sleeve

XEPRB25LINPC 25 MHz Linear Probe for Anterior Chamber / Including Calibration Tool, Probe Holder, parameters USB key and User Manual

XEPRB50LINPC2 50 MHz Linear Probe / Including 1 Pack of 10 Filmed Windows + 1 Cap, Calibration Tool, Distilled Water (pack of 5 unidoses), 2 ClearScan, Probe Holder, Parameters USB key and User Manual

OPTIONS

XEDICOM DICOM Connectivity Optional Software to export data to a server in DICOM standard

7.2. Accessories and consumables CODE ITEM

ACCESSORIES XEPCCALIBECRAN Screen Calibration Tool XEAAA3COQB Set 3 Scleral Shells for B mode (19-22-24 mm) XEAAA3COQBIO Set 3 Scleral Shells for Biometry (20-22-24 mm) XEAAA5COQBIO Set 5 Scleral Shells for Biometry (16-18-20-22-24 mm) XEAAACOQLIN14 Scleral Shell 14 mm for Linear Probes XEAAACOQLIN16 Scleral Shell 16 mm for Linear Probes XEAAACOQLIN18 Scleral Shell 18 mm for Linear Probes XEAAACOQPRAEG15 Präger Shell 15 mm for Biometry (children) XEAAACOQPRAEG17 Präger Shell 17 mm for Biometry (adults) XEAAAPAM Extension Handle for Biometry Probe XEAVIADAPVESA VESA Mount Adapter Kit for Apple iMac 21’’ XEAVIPSD2 Probe Holder XEAVIPSD3 Probe Holder XEAAAPED Footswitch XEAVICHARIOT Trolley XEAVICROSS Metal Bracket for Probe Holder XEAVIVALISE Carrying Case XEHUBUSB USB Hub XEIMPUSBLASER USB Laser Printer * XEIMPUSBSONY USB Sony Video Printer XELIVRE1 Clinical Echography of the Eye and Orbit Monograph XEPL Beam Box Laser Pointer

XEPRBSLEEVE Finger Grip Sleeve for 2nd Gen. B Probe

CONSUMABLES XEAAAGEL 250 ML Gel for echography XEPRBFEN2 Filmed windows for 2nd Gen 50Mhz Linear Probe (box of 10 pcs) XEPRBFS ClearScan for 50MHz Linear Probe - diam. 25 mm (box of 10 pcs)



7.3. Spare parts CODE ITEM

XEAVICAPOT Main cover XEAVICPUPCB CPU board XECT2POW Power board XEAVIERMPCB AVISO Emitter / Receiver board (Interface board) XEAVISERMPCB AVISO S Emitter / Receiver board (Interface board) XLVITECRAN LCD screen XLVITDALLE Touch screen XLVITAPPDALLE Touch screen strip support XEAVIPEM Power empty module XLVITBOUTON Power button XEAAAFAN Cooling fan



8. DISASSEMBLING THE UNIT TO REPLACE DEFECTIVE SPARE PARTS 8.1. Removing the main cover

Before any intervention on the AVISO / AVISO S unit: unplug the mains cord located at the back of the unit and remove all connections.

To remove the main cover:

1/ Pull the power button from the front of the unit to remove it:

2/ Remove the button that fixes the probe holder to the unit:

3/ Unscrew all 8 screws located at the bottom of the unit:



4/ Unscrew the 2 screws located at the back of the unit:

Rear plate

5/ To access the sub-system monobloc, remove: - The back cover with care by pulling it backward - The front cover - The rear plate

WARNING The touch screen is fragile. 6/ The monobloc can be separated in two by unscrewing the 3 screws (M3x6) as shown here:



8.2. Accessing subsystem boards

8.2.1. Removing the interface board (XEAVIERMPCB / XEAVISERMPCB)

1/ Completely unscrew the B probes connectors nuts (2) with flat pliers and remove them.

2/Unplug the two cables from the surrounded connectors .Then unscrew the two screws that hold the cooling fan plate in place. Remove the cooling fan.

Interface board

Cooling fan

Power supply board

CPU board

Power button

Power empty module

Touch screen



3/ Finally remove the 4 screws that hold the interface board to the bottom frame as indicated here:

8.2.2. Removing the power supply board (XECT2POW)

1/ Disconnect the connectors as indicated by the arrows.

2/ Unscrew the 2 screws (M3x6) located under the AVISO / AVISO S unit. The power supply board can then be removed from the main frame.

8.2.3. Removing the CPU board (XEAVICPUPCB)

The CPU board is located behind the touch screen block:

To remove the CPU board: - Disconnect all CPU board cables with

caution (5 cables – surrounded in red). - Unscrew and remove the 4 screws (M3x6)

located behind the touch screen board.



8.2.4. Removing the screen (XLVITECRAN) + touch screen (XLVITDALLE)

assembly - Disconnect all CPU board cables with

caution. - Then: unscrew and remove the 4 screws

(M3x6) as indicated by the arrows.

- Remove the metallic frame to access the

touch screen. - Lift the metallic holders as indicated by

the arrows.

- The LCD touch screen can then be

removed from the front metallic frame and replaced.



WARNING

The operation to replace a damaged touch screen is delicate, however possible: The touch screen is simply lying over the surface of the screen (with a silicon flat joint in between). After assembly, the touch screen calibration must be performed.

9. TOUCH SCREEN CALIBRATION The AVISO / AVISO S module touch screen may have to be calibrated after servicing or transportation.

NOTE - Read the entire calibration procedure before starting the calibration. - It is recommended to use a thin plastic stick such as a PDA pencil to calibrate the touch screen module.

Touch screen calibration procedure:

1. Disconnect the AVISO / AVISO S module USB connection to the computer. 2. Switch on the AVISO / AVISO S module and wait for the home page to be displayed. 3. Turn the AVISO / AVISO S module power knob clockwise until the following calibration screen is

displayed:

4. Press the “START” button. 5. Wait for the first beep that corresponds to the beginning of the calibration procedure. 6. Press “P” until the second beep can be heard. 7. Then, successively press the four screen corners of the touch screen: each time a corner is pressed,

repetitive beeps can be heard. This means the screen pressure is correctly recognized to ensure it is possible to move on to the following corner.

8. Once the four corners have been pressed: press “P” again to complete the calibration procedure. 9. It is then necessary to press “SAVE” to save the calibration: the home page will then be displayed again.

10. Reconnect the AVISO / AVISO S module USB connection to the computer.

NOTE It is possible to abort the calibration procedure by selecting “ESC”, or to restart the calibration procedure by selecting “START” again.



10. AVISO / AVISO S COMPUTER DISPLAY 10.1. AVISO / AVISO S COMPUTER SCREEN CALIBRATION CHECK

The computer screen calibration can be checked as follows:

On the computer, select Start/ QUANTEL MEDICAL / Calibration Screen as shown below:

The following image is displayed on the screen:

Check that:

1 - All 16 luminance patches are distinctly visible. 2 - The small patches (5% or 95% with 0% or 100% surrounding) are distinctly visible on the inner sides of

the patches to both sides of the pattern name. 3 - The pattern is free of artefacts, especially at the boundaries of transition from black to white and white to

black. 4 - This image shows QUALITY CONTROL three times:

- One on the left: very close to black, - One on the right: very close to white, - and in the middle: each letter has different gray level.

NOTE Bad screen inclination or screen exposition to bright light source (next to a window or artificial light) may alter the image quality.



In case the screen calibration check is not correct, it may be necessary to calibrate the computer screen:

Before calibration, check that: 1/ The highest screen resolution has been chosen 2/ The computer monitor is in high color or 24-bit mode 3/ Wait for the monitor to warm up for at least 15 min 4/ Make sure that no reflections, glare or strong, direct light reaches the screen Then calibrate the computer monitor as follows: 1/ Adjust contrast and brightness controls 2/ Adjust color levels 3/ Use a basic calibration software to perform the calibration (such as Adobe Gamma, Quick Gamma ..) 4/ Use specialized software in conjunction with a colorimeter for optimum visual accuracy. In case the screen calibration check is still not correct: contact QUANTEL MEDICAL.

10.2. AVISO / AVISO S COMPUTER ADJUSTMENTS TO BE DONE FOR

WINDOWS® EIGHT (8.1 VERSION)

10.2.1. Navigation properties setup with Windows® Eight (8.1 version)

To ease the use of the AVISO / AVISO S application, it is necessary to customize Windows® Eight naviguation properties to:

a. Display the Desktop with the AVISO / AVISO S background by default instead of the regular Windows® Eight start up screen.

NOTE

Windows® Eight 8.1 version is required to display the AVISO application (Desktop) by default upon startup.

b. Remove the charm bar when moving the mouse cursor to the upper right corner of the screen. c. Remove the recent apps display when moving the mouse cursor to the upper left corner of the screen.

Procedure to adjust navigation properties as indicated in a, b and c: In the Desktop, right click on the bottom bar to select “Properties”:



Select or unselect the checkboxes as indicated below:

Restart the computer and check that the desktop screen is selected by default upon startup.

10.2.2. Adjust magnifier tool

To ensure that the text in the AVISO screen is not truncated, the magnifier tool parameter has to be adjusted as shown below (to the smaller size), and select “Apply”:

Uncheck those boxes for b. and c. navigation properties adjustments.

Check this box for a. navigation properties adjustment.



11. PROBES MANAGEMENT AND CALIBRATION 11.1. Standardized (A-Std) / regular biometry (A) probe

WARNING

Anytime a probe is replaced or changed, it is necessary to check / adjust the calibration.

11.1.1. Adding or removing a standardized / regular biometry probe & calibration

Each probe has specific parameters. The list of already installed probes parameters is displayed in the probe setup screen as shown below:

Example given for the AVISO S unit:

This list should correspond to the serial numbers of the probes currently in use on the unit.

11.1.2. Delete or add a new standardized or regular biometry probe

To delete a probe, select its serial number and then the “delete” button:

. To install a new probe, insert its matching CD-Rom into the drive and press the “add” button:

This window will then be displayed: Select the file (with the probe’s serial number that has to be installed) and select: “Open”. The probe will consequently be added to the probe in use list.

WARNING

- The serial numbers of the listed probes should correspond (and only correspond) to the serial numbers of the probes actually connected or used on the unit! - Two probes of the same type should not be displayed in the list. If this is the case (their parameters are installed), then the AVISO / AVISO S can use the wrong calibration and measurements will therefore be wrong. The probe not currently in use on the unit has to be removed from the list.



11.1.3. Tissue sensitivity determination for A-Std type of probe (AVISO S only)

NOTE The Tissue Sensitivity has to be determined for the whole system: AVISO S unit and A-Standardized probe (using the tissue model). Another probe with the same AVISO S unit may have a different T Gain.

Select the A-Std probe for which the tissue sensitivity determination has to be performed (window on left) and then select “Tissue Sensitivity Determination”:

Tissue sensitivity screen functions:

Ignore / Inc.

Ignore or include a measurement in the column / modify the average calculation.

Del select

Delete the selected column in the result table.

Delete all

Delete all data in the result table.

T value is the measurements average. The “-” or “+” signs allow the user to manually adjust the T value (unfrozen mode)

The A-Scan height has to be adjusted to 60mm (measured with a ruler against the computer screen) using the “-” or “+” signs.



a) AUTO MODE:

Place a drop of water on the surface of the tissue model and position the probe vertically in contact, on top of the tissue model. Follow the indications on the screen (Step 1 to 3). After 10 measurements, the automatic acquisition is stopped. The measurements average is calculated and displayed at the bottom of the result table. This procedure can be done five times (five columns). The T gain value is the average of all measured values and is displayed on the left side of the screen (T). At the end of the automatic tissue sensitivity determination procedure, select “SAVE” to validate or “CANCEL” to abort.

b) MANUAL MODE:

Manually adjust the gain using the “-” or “+” signs to get a “linear” decrease:

When the correct gain is found, select “SAVE” to validate that gain as the T reference. The program will then automatically close the tissue sensitivity determination window to display the Physician screen.

11.1.4. Measurement test / standardized or regular biometry probe calibration

The Test-Block is located on the probe holder at the back of the unit. It is a plastic block used to test and calibrate the A (AVISO) / A-Std (AVISO S) scan measurements. The test block has an equivalent thickness of 10 mm at a velocity of 1550 m/s.

The test block used to perform the biometry calibration is different between the AVISO (with regular biometry probe) and AVISO S (standardized biometry probe):

The test block used with the AVISO has a rounded convex shape to match the concave shape of the “regular” biometry probe’s tip.

The test block used with the AVISO S has a flat shape to match the flat shape of the “standardized” probe’s tip.

Select the A (AVISO) / A-Std (AVISO S) probe for which the calibration has to be performed (window on left) and then select “Test Block”:

WARNING

The calibration process is the same for the “regular” type of biometry probe and probeam probe (biometry probe for a laser aiming beam).



AVISO :

AVISO S :

Put a drop of water on the Test-Block and position the probe on the test block to be as much perpendicular and well centered as possible.

A tracking starts: the purpose is to record the measurement with the highest posterior face echo. This measurement will correspond to the best probe position, well perpendicular to the posterior face.

Two values are displayed: · “Best =” is the measurement corresponding to the best image. · “Current =” is the measurement corresponding to the current

position of the probe. For a good calibration, the probe should measure a thickness situated in between 10.00 and 10.11mm. If the measurement is not within these range (best and current), the “position of Marker #1 in contact” cursor should be adjusted. Press OK to save the calibration. Select “Clear” to erase the “Best” and “Current” fields and start a new measurement.

WARNINGS

- If the biometry and probeam probes are in use on the AVISO S unit, the calibration for both probes has to be done. Also, the appropriate probe has to be selected in the biometry screen when performing an exam in order to have the calibration corresponding to the connected probe!

NOTES - AVISO S only: when the A-Std probe is used for measurements and IOL calculation, the “Axial length”

mode method should be selected. - This correction is impacting 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.



11.2. Adding / suppressing other probes (B10, HFP, LIN 25MHz and LIN 50MHz)

Each probe has specific parameters. The list of already installed probes parameters is displayed in the probe setup screen as shown below:

This list should correspond to the serial numbers of the probes currently in use on the AVISO / AVISO S unit.

To delete a probe, select its serial number and then select the “delete” button:

To install a new probe, insert its matching CD-Rom into the drive and press the “add” button:

Select the file (with the probe’s serial number that has to be installed) and select: “Open”. The probe will consequently be added to the probe in use list:

WARNING

- Make sure that only one same type of probe is displayed in the list. If not, delete the probe not currently in use.

- In case the LIN 50MHz type of probe is used, follow the calibration checking procedure (before using the probe) as explained in next section:

Section 11.3: Linear probes calibration check



11.3. Linear probe calibration check

WARNING To use the probe for sizing: the probe calibration should systematically be checked.

11.3.1. Calibration tool

Each probe is delivered with a calibration tool that has been checked against a master tool.

DESCRIPTION LIN 25 LIN 50 The probe type is “engraved” on the side of the tool: LIN25 or LIN50. A label indicating the distance D (between the pins) is stuck on the tool.

Two metallic pins which distance is used for calibration are located inside the tool.

11.3.2. Calibration setup

A. Equipment · 1 calibration tool corresponding to the probe type · Demineralized water at temperature between 20°C and 25°C

B. Calibration setup

CAUTION It is very important to stop the probe scanning motion while setting up the calibration procedure (freeze the image using the footswitch).

C. LIN 25

· Fill up the calibration tool with demineralized water..

· Position the probe on the calibration tool. The probe is now ready to be checked: perform the checking procedure as described in the following section. Note: never immerse the probe tip over 3 cm.



D. LIN 50

CAUTION Place the removable window on the probe.

· Fill up the calibration tool with demineralized water. · Position the probe on the calibration tool.

The probe is now ready to be checked: perform the checking procedure as described in the following section. Note: never immerse the probe tip over 3 cm.

11.3.3. Calibration procedure

· Switch the AVISO / AVISOS module and computer on. · Select Lin 50 or Lin 25 (connected probe), then select “Scan” · Press the footswitch to activate the probe’s motion: the image that follows is now displayed on the

screen:

· Adjust the gain to get the best image quality (clear and precise).



· Press the footswitch to freeze the image:

· Place calipers as follows:

C1: Measure of the distance between the calibration tool pins.

Check the C1 measurement result (measure of the distance between the calibration tool pins). This result should correspond to the D value (with its tolerance) written on the label slicked on the calibration tool border.

LIN 25 LIN 50 D= 11mm (± 0,06mm)

i.e. 10,94mm < D < 11,06mm

D= 11mm (± 0,06mm)

i.e. 10,94mm < D < 11,06mm

WARNING In case the measurement result is out of range: the probe can be used for diagnosis only BUT NOT for sizing. Contact your local distributor or the QUANTEL MEDICAL Service Department.



11.3.4. Solving noise problems (with Lin 50 MHz acquisition mode)

NOTE The AVISO / AVISO S tolerance should display 5dB as maximum noise; it means that when the image is displayed on the screen at 105dB, the noise has to be very low. Noise may be a reduced when using the Lin 50MHz probe. To check and simulate that the noise level is correct for examination:

ü Prepare the probe (as for an exam): fill the probe with demineralised water and install the removable window.

ü Put the removable membrane in contact with your hand, ü Start the probe and check if the noise is increased or not when the probe is in contact with your hand.

If the noise is increased when in contact with your hand: noise will be present during patient examination. It is then necessary to investigate which of the following elements is generating noise to reduce it as much as possible:

· Check the room grounding is correct, (the earth impedance has to be lower than 0.1 ohms). · Try to connect the AVISO / AVISO S and computer power supply module on another plug in the room or

try to change room if the problem persists, · Check the lin50 cable is not in contact with: o The computer or AVISO / AVISO S power supply module, o The AVISO / AVISO S module or computer screen, o The AVISO / AVISO S USB cable,

· Check the Lin50 cable is straight (not entangled), · Try to switch off the light, air conditioned system, phone…(in the room or in another room), · Check that the other units installed nearby the AVISO / AVISO S unit do not generate noise; if this is the

case: switch off this unit when using the Lin 50MHz probe. · Check the noise impact of any other peripheral connected to the computer: for example a printer · Check that the computer is not connected to the network: disconnect the RJ-45 cable and check the

image again. · It is not recommended to use a wireless mouse.

11.4. Probes care

Linear probes storage:

LIN25 LIN 50 1- Place the black cap on the probe aperture

to protect the membrane.

2- Store the probe inside its box.

1- Remove and throw away the white removable window.

2- Drain out the water from the probe. 3- Place the black cap on the probe aperture

to avoid dust penetration. 4- Store the probe inside its box.



12. AVISO / AVISO S SOFTWARE COMPATIBILITIES 12.1. Software Version versus Operating System compatibilities

WARNING There is no compatibility between the AVISO and AVISO S software.

AVISO SOFT VERSION

1.xx 2.xx

AVISO S SOFT VERSION

3.xx 4.xx 5.xx

Windows XP Yes Yes Yes

Not recommended: risk to reduce

AVISO software performances



Windows Vista 32 bits* No No Yes Yes



Windows Vista 64 bits* No No No No No

Windows Seven 32 bits* No No Yes** Yes Yes

Windows Seven 64 bits* No No No Yes Yes

Windows 8 64 bits* No No No No Yes

NOTES - * Compatible with the UAC (User Account Control) activated or not. - **A special procedure has to be used to install the AVISO S Version 3.00 software with Windows Seven

32 bits Operating System: indeed, in this case, the “AVISO S Setup.exe” file should not be used for the installation, but the “DXSETUP.exe” file located in the “DirectX” folder should be installed instead. Then: install the “setup.exe” file located in the “Data” folder.

WARNING Windows 8 does not allow the software to install the database in: “C:\program Files\QUANTEL MEDICAL\AVISO” directory As a consequence, the database is still located in: “C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO” directory, with the UAC (User Account Control) is activated or not.



12.2. Software upgrade & compatibilities

WARNING There is no compatibility between the AVISO and AVISO S software.

Upgrading from Soft Version:

To Soft Version: Compatible:

AV

ISO

1.xx

2.xx* Yes 3.xx No** 4.xx No** 5.xx No**

2.xx 3.xx Yes 4.xx No** 5.xx No**

AV

ISO

S

3.xx 4.xx Yes 5.xx No**

4.xx 5.xx Yes

NOTES - It is not possible to upgrade the AVISO to AVISO S (and vice versa) - Downgrading the system is prohibited. With a downgrade, the database will be damaged or corrupted.

Also, the exams realized with the most recent version and read with an older one will not be displayed (black image).

- *After upgrading the AVISO software from Version V1.XX to V2.XX: it is necessary to upgrade the database using the “UpdateAVISODatabase.exe” software (with un-activated UAC)

- **To upgrade the AVISO software from Version 1.XX to V5.XX: it is mandatory to install intermediary software versions.

- When upgrading the AVISO S from Version 5.00 to Version 5.01, it is necessary to follow the AVISO S Version 5.01 installation notice procedure: Section 6.2. In case of a software upgrade. Indeed, after having uninstalled the previous AVISO S program (V.5.00), it is necessary to uninstall the “SAP Crystal Reports” 32 bit and 64-bit programs before installing the new AVISO S Version 5.01 program (by selecting “Setup.exe”).



12.3. AVISO / AVISO S software version 5.XX: module and probe parameters compatibilities

The new AVISO / AVISO S module version for the new software version 5.XX is able to control Zoom functions: - Zoom25 for B10MHz probe and - Zoom30 for HF-P probe

Those new zoom functions can only be displayed with the following combination:

· The AVISO / AVISO S software version 5.XX installed on the computer.

· A new AVISO / AVISO S module version: SoftV2.00 and HardV5.00

NOTE Module upgrade is not possible.

· New probe / last generation B10MHz (for Zoom25) or HF-P (for Zoom30) probe & parameters The last generation probe parameters include a “pb2” file:

ü The new B10 probe parameters include two files: First one called “prb”, including the following modes: - “Slow40” mode: the image is acquired at 9Hz with a depth of 40mm, - “Slow60” mode: the image is acquired at 9Hz with a depth of 60mm, - “Fast40” mode: the image is acquired at 16Hz with a depth of 40mm, - “Fast60” mode: the image is acquired at 16Hz with a depth of 60mm,

Second one called “pb2”, including the following modes: - “Slow40” mode: the image is acquired at 9Hz with a depth of 40mm, - “Slow60” mode: the image is acquired at 9Hz with a depth of 60mm, - “Zoom25” mode: the image is acquired at 9Hz with a depth of 25mm, - “Fast40” mode: the image is acquired at 16Hz with a depth of 40mm, - “Fast60” mode: the image is acquired at 16Hz with a depth of 60mm,

ü The new HF-P probe parameters include two files: First one called “prb”, including the following modes: 1. “Slow40” mode: the image is acquired at 9Hz with a depth of 40mm, 2. “Fast40” mode: the image is acquired at 16Hz with a depth of 40mm,

Second one called “pb2”, including the following modes: Ø “Slow40” mode: the image is acquired at 9Hz with a depth of 40mm, Ø “Zoom30” mode: the image is acquired at 9Hz with a depth of 30mm, Ø “Fast40” mode: the image is acquired at 16Hz with a depth of 40mm.

NOTE Ø Probe & parameters upgrade is not possible. Ø The software version V5.XX will automatically detect the module software version and permit to install

the “prb” or”pb2” file (in both cases displayed as “prb” in the software). This is the reason why it is necessary to connect the module when installing probe parameters. If not, the following message will be displayed: “Please connect and switch on the module” and the “Add” key will not be active.

Ø The previous software versions (from 1.xx to 4.xx) cannot install “pb2” probe parameters files.



As a summary: new Zoom functions (Zoom25 for B10MHz probe and Zoom30 for HF-P probe) are available for:

Module Software version

AVISO/ AVISO S Software Version

Probe Parameters file installed: “prb” or “pb2”

New Zoom function

availability SoftV1.xx HardV4.xx 1.xx to 5.xx “prb” file NO

SoftV2.00 HardV5.00 1.xx to 4xx “prb” file NO

SoftV2.00 HardV5.00

5.xx “pb2” file YES

NOTE In case the “pb2” probe parameters file has been installed with the module SoftV2.00 and HardV5.00 and if the module is replaced by a module with previous version (SoftV1.xx HardV4.xx): the Zoom functions (Zoom25 for B10MHz and/or Zoom30 for B HF-P) will be displayed in the SCAN screen, but it will be impossible to display any image and, the following error message will be displayed: “This mode is not available with this module. Please select another mode or change the module”.

13. DATABASE MANAGEMENT 13.1. Database information

The database information is stored in the following folders: ü Cineloop folder, which contains all saved Cineloops, ü Data folder, which contains all patient exams, categorized by Physician and Patient names, ü Probes folder, which contains all probe parameters, ü BusBdataAxl.mdb files, which contains the Physician and Patient files, probe calibration, keycode… ü Config.bin file, which contains the unit configuration (such as probe calibration, keycode, option

selection…), ü DcmConfig.bin file, which contains the Dicom configuration, ü DcmFiles folder, which contains the Dicom files before sending to the PACs. ü Shortcut List Comment.txt file, which contains the Comments Shortcuts List. ü Worklist Order.txt file, which contains the list and information order displayed in the worklist.

Those database folders are located as explained in the next section (13.2.) Exported data (such as JPEG, PDF…) are located by default under: “C:\AVISO or AVISO S”. However, this location can be customized for each Physician (“Selections” tab of the “Physician Info” screen). This AVISO or AVISO S directory contains the following folders:

ü Cineloop folder, which contains all exported exams in AVI format, ü EMR folder, which contains all exported exams in EMR format (JPEG + xml files), ü JPEG folder, which contains all exported exams in JPEG format, ü PDF folder, which contains all exported exams in PDF format.



13.2. Database location The database location depends on the Operating System and UAC (User Account Control) settings:

NOTES Ø QUANTEL MEDICAL (highlighted in yellow colour) corresponds to the session name of the computer; so

this name may be different if the computer session name is different. Ø When installing the AVISO / AVISO S software, the directory to be selected by default is “C:\Program

Files”. In case the user has chosen a different directory for the installation: the UAC will have no effect and data will be stored in this customised directory.

Ø « AppData » folder is a hidden folder: select « Display hidden files and folders » in: Control Panel/folder options or type the complete path.

Ø Activating / Unactivating the UAC (User Account Control): For Windows VISTA:

Select: 1/ Control Panel 2/ User Accounts 3/ Turn User Account Control ON or OFF 4/ Select / unselect the “Use User Account Control (UAC)” to help protect your computer

For Windows SEVEN / EIGHT: Select: 1/ Control Panel 2/ User Accounts 3/ Change User Account Control settings 4/ Modify the cursor position up (to use the UAC) or down (“Never notify” to remove UAC):

Operating System UAC Database location

Windows XP N/A C:\Program Files\QUANTEL MEDICAL\AVISO (or S)

Windows Vista 32 bits

Activated C:\Users\QuantelMedical\AppData\Local\VirtualStore\Program Files\QUANTEL MEDICAL\AVISO (or S)

Un-activated C:\Program Files\QUANTEL MEDICAL\AVISO (or S) Windows Vista

64 bits Activated Not applicable: not compatible

Un-activated Not Applicable: not compatible

Windows Seven 32 bits

Activated C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files\QUANTEL MEDICAL\AVISO (or S)

Un-activated C:\Program Files\QUANTEL MEDICAL\AVISO (or S)


Activated C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)

Un-activated C:\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)

Windows 8 64 bits

Activated C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S) Un-activated



CAUTION The UAC position should not be changed once the AVISO / AVISO S software has recorded data in its database. In case the UAC position is modified: a new database will be created. Since two databases cannot be merged: previous recorded data will not be accessible anymore.

13.3. Saving the database From the database location (as described in the above section 13.2): 13.3.1. Save database (for AVISO Software Version 1.XX) The AVISO Software Version 1.XX database is stored under BusBdataAxl.mdb (with all the examination images) and a cineloop folder.

NOTE After software upgrade from AVISO Software Version 1.XX to Version 2.XX, it is necessary to run the “UpdateAVISODatabase.exe” file located under C:\Program Files\QUANTEL MEDICAL\AVISO to update the database. This program allows the database to export the images from the BusBdataAxl.mdb file to the Data folder. 13.3.2. Save database (for AVISO Software Version 2.XX / AVISO – AVISO S Version

3.XX) To save the AVISO Software Version 2.XX / AVISO – AVISO S Version 3.XX database, save the database files and folders as described in the above section 13.1: Database information.

13.3.3. Save the database (for the AVISO / AVISO S Software Version 4.XX and 5.XX) The “Archive Database” function allows the user to automatically copy the database files under a chosen path:

The database files (as described in the above section 13.1: Database information) are then automatically saved to a chosen location (on the computer, network, USB key).



13.4. Where to re-install the database after upgrading the OS

WARNING The database has to be pasted in the same location than where it was copied when changing the OS of the AVISO / AVISO S computer. Also, the UAC settings have to be configured similarly:

FROM TO

OS Version UAC Copy the database from location:

OS Version UAC Paste saved database on new OS to the location”:

Windows XP N/A C:\Program Files\QUANTEL MEDICAL\AVISO (or S)

Windows XP N/A Paste data in the directory: “C:\Program Files\QUANTEL MEDICAL\AVISO (or S)”


and Seven 32 bits

UAC ON

Not Compatible with the UAC switched ON! Follow the procedure below:

1. Switch OFF the UAC. 2. Paste database in the directory: “C:\Program Files\QUANTEL MEDICAL\AVISO (or S)”


and Seven 32 bits

UAC OFF

1. Keep the UAC switched OFF. 2. Paste data in the directory: “C:\Program Files\QUANTEL MEDICAL\AVISO (or S)”

Windows Seven 64 bits and Eight 64

bits

UAC ON or OFF Not compatible

Windows Vista 32 bits and

Seven 32 bits

UAC ON

C:\Users\QUANTEL MEDICAL\AppData\ Local\VirtualStore\ Program Files\QUANTEL MEDICAL\AVISO (or S)

Windows XP N/A Not compatible


and Seven 32 bits

UAC ON

1. Keep the UAC switched ON. 2. Paste data in the directory: “C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files\QUANTEL MEDICAL\AVISO (or S)”

UAC OFF Not compatible


bits


UAC OFF

C:\Program Files\QUANTEL MEDICAL\AVISO (or S)

Windows XP N/A Not compatible


and Seven 32 bits

UAC ON

Not Compatible with the UAC switched ON! Follow the procedure below:

1. Switch OFF the UAC. 2. Paste database in the directory: “C:\Program Files\QUANTEL MEDICAL\AVISO (or S)”

UAC OFF

1. Keep UAC switched OFF. 2. Paste data in the directory: “C:\Program Files\QUANTEL MEDICAL\AVISO(or S)”


bits




FROM TO

OS Version UAC Copy the database from location: OS Version UAC Paste saved database on new OS to the location”:


UAC ON

C:\Users\QUANTEL MEDICAL\AppData\ Local\VirtualStore\ Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)

Windows XP Vista 32 bits and

Seven 32 bits N/A Not compatible


UAC ON

1. Keep the UAC switched ON. 2. Paste database in the directory: “C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)”

UAC OFF

Not Compatible with the UAC OFF! Follow the procedure below:

1. Switch ON the UAC. 2. Paste data in the directory: “C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)”

Windows Eight 64bits

UAC ON or OFF

Paste data in the directory: “C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)”

UAC OFF

C:\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)

Windows XP Vista 32 bits and

Seven 32 bits N/A Not compatible


UAC ON

Not Compatible with the UAC switched ON. Follow the procedure below:

1. Switch OFF the UAC. 2. Paste database in the directory: “C:\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)”

UAC OFF

1. Keep the UAC switched OFF. 2. Paste data in the directory: “C:\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)”


UAC ON or OFF

Paste the database in the directory: C:\Users\QUANTEL MEDICAL\AppData\ Local\VirtualStore\ Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)


UAC ON or OFF

C:\Users\QUANTEL MEDICAL\AppData\ Local\VirtualStore\ Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)

Windows XP Vista 32 bits,

Seven 32 bits, Windows Seven

64 bits

N/A Not compatible


UAC ON or OFF

Paste the database in the directory: C:\Users\QUANTEL MEDICAL\AppData\ Local\VirtualStore\ Program Files (x86)\QUANTEL MEDICAL\AVISO (or S)

NOTES Ø QUANTEL MEDICAL (highlighted in yellow colour) corresponds to the session name of the computer; so

this name may be different if the computer session name is different. Ø Windows vista 64 bits is not mentioned in the above table, because this operating system is not

compatible with the AVISO / AVISO S software.



WARNINGS Ø The UAC position should not be changed once the AVISO / AVISO S software has recorded data in its

database. In case the UAC position is modified: a new database will be created. Since two databases cannot be merged: previous recorded data will not be accessible anymore.

Ø The AVISO database is not compatible with the AVISO S database (and vice versa). Ø After having copied the database in the new Operating System location: check that all data are

accessible when opening the AVISO / AVISO S application. In case the list of Users is empty: check the above table and restart the procedure to pate the saved database.

Ø In case the user has chosen a different directory for the installation: the UAC will have no effect and data will be stored in this customised directory.

Ø For Windows Eight 64 bits with the UAC turned ON or OFF: The database is located under: C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S) In case the database (including the Data and Cineloop folders) has been copied by error under: C:\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S) Instead of: C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S) Then, the next time the AVISO / AVISO S software is saving data: the updated database is automatically copied under: C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S) However, the Data and Cineloop folders are not copied and remain in the same location: so that two locations coexist. The database, Data folder and Cineloop folder located under: C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S) Are the only one used and incremented from now on. But the database located under: C:\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S) Should not be suppressed. Otherwise, the software will create a new database.

Ø For Windows Eight 64 bits with the UAC turned ON or OFF: When using the “Archive Database” function: data located under: C:\Program Files\QUANTEL MEDICAL\AVISO (or S) And C:\Users\QUANTEL MEDICAL\AppData\Local\VirtualStore\Program Files (x86)\QUANTEL MEDICAL\AVISO (or S) Are saved in the same backup folders.



13.5. AVISO / AVISO S software installation & data transfer from a computer 32-bits to a computer 64-bits

There are compatibility issues between a 32-bits computer and a 64-bits computer. With a 64-bits computer, the AVISO / AVISO S software can absolutely not be installed under “C:\Program Files\” anymore because Windows will always put it by default under “C:\Program Files(x86)\”. As a consequence, the following procedure should be followed to “safely” transfer AVISO / AVISO S data from a 32-bits computer to a target 64-bits computer.

WARNING This procedure should only be followed by trained service engineers when wanting to transfer AVISO / AVISO S data from a computer with a 32-bits processor to a computer with a 64-bits processor.

NOTES 1. This procedure is only applicable in case the AVISO / AVISO S software has been installed (on

the 32-bits computer) in the default directory: “C:\Program Files\Quantel Medical\Aviso”. If the installation has been done in a different directory, the following procedure cannot be applied.

2. In case of a regular AVISO / AVISO S software installation (with no data transfer from a 32-bits system), the regular installation procedure should be followed. It is available in the AVISO / AVISO S installation notice and service manual.

PROCEDURE STEPS:

STEP 1. Copy data from the 32-bits computer.

Do not use the “Archive database” automatic function, but refer to Section 13 – Database management of the service manual to manually select and copy the database files under a safe location. Indeed, the database location depends on the Operating System and UAC (User Account Control) settings.

STEP 2. Install the AVISO / AVISO S software on the target 64-bits computer choosing the

directory given by default: “C:\Program Files(x86)\Quantel Medical\Aviso”

STEP 3. Copy the Quantel Medical\Aviso(S) directory from “C:\Program Files(x86)\” under “C:\Program Files\”

STEP 4. According to the target computer configuration, follow the adequate step indicated below

(depending on the Operating System and UAC settings):

Ø If the target computer Operating System is Windows 7 with UAC ON, or Windows 8: § Launch the AVISO / AVISO S located under “C:\Program Files\Quantel Medical\Aviso” and

straightway close the AVISO / AVISO S software without creating any new data (user, patient, nor exam). This action generates the creation of the directory: “C:\Users\QM\AppData\Local\VirtualStore\Program Files\Quantel Medical\Aviso”

§ Remove the files located under: “C:\Users\QM\AppData\Local\VirtualStore\Program Files\Quantel Medical\Aviso”

§ Copy the 32-bits computer database data to the target 64-bits computer under: “C:\Users\QM\AppData\Local\VirtualStore\Program Files\Quantel Medical\Aviso”



NOTES

1) With this configuration, the “BusbDataAxl.mdb” file located under “C:\Program Files\Quantel Medical\Aviso” is not used; only the virtualized file is used (the one located under VirtualStore). As a consequence, the “BusbDataAxl.mdb” file located under “C:\Program Files\Quantel Medical\Aviso” may be suppressed.

2) QM (highlighted in yellow colour below) corresponds to the computer session name; so this name may be different if the computer session name is different: “C:\Users\QM\AppData\Local\VirtualStore\Program Files\Quantel Medical\Aviso”

Ø If the target computer Operating System is Windows 7 with UAC OFF: § It is not necessary to launch the AVISO / AVISO S software. § Copy the 32-bits computer database data to the target 64-bits computer under: “C:\Program Files\Quantel Medical\Aviso”

STEP 5. Suppress the 3 shortcuts as indicated below:

Localisation Windows 7 Windows 8

1 - Desktop Delete the desktop shortcut :

2 - Quantel Medical folder

In the Metro user interface and “All Apps”, right click on Aviso/Aviso S and select: “Open file location”.

Delete the AVISO / AVISO S shortcut located under : “C:\ProgramData\Microsoft\Windows\Start Menu\Programs\Quantel Medical” :



3 - « Start » menu

In Startup, delete the AVISO / AVISO S shortcut located under : “C:\ProgramData\Microsoft\Windows\Start Menu\Programs\StartUp”

STEP 6. Modify the AVISO / AVISO S directory located under: “C:\Program Files (x86)\” to avoid

creating another AVISO / AVISO S database:

§ Rename the “BusbDataAxl.mdb” file located under: “C:\Program Files(x86)\Quantel Medical\Aviso” to “BusbDataAxl-old.mdb” § Suppress the “Aviso_Setup” file located under:

“C:\Program Files(x86)\Quantel Medical\Aviso”, and “C:\Program Files\Quantel Medical\Aviso”. This suppression makes it possible to avoid recreating the AVISO / AVISO S functionality under: “C:\Program Files(x86)\Quantel Medical\Aviso”

NOTE When the database does not exist anymore and if the AVISO / AVISO S software is launched using the “Aviso.exe” file or shortcut, the following error message is displayed:



STEP 7. Recreate the AVISO / AVISO S shortcuts (using the Aviso file located under C:\Program Files\) and rename the Shortcuts (removing _shortcut). The procedure to recreate the shortcuts is the same Windows 7 and Windows 8:

Action W7 et W8

Create the desktop shortcut. Select the AVISO / AVISO S file located under : “C:\Program Files\Quantel Medical \Aviso“ And click on: “Send to \ Desktop“

Copy the shortcut that has been created on the desktop to the Start menu under : “C:\ProgramData\Microsoft\Windows\Start Menu\Programs\Quantel Medical”

Copy the shortcut that has been created on the desktop to the Startup menu, under : “C:\ProgramData\Microsoft\Windows\Start Menu\Programs\StartUp”



STEP 8. Create the “Aviso Setup” shortcut § Copy the AVISO / AVISO S shortcut that has been created on the desktop under: “C:\Program Files\Quantel Medical \Aviso “ § Rename the “Aviso.exe – shortcut” by “Aviso_Setup” § Modify the file properties:

- Right click on the file, - Select “Properties”, - Select the “Shortcut” tab, - Modify the “Target” path by adding “/setup” after the quotation marks:

"C:\Program Files\Quantel Medical\Aviso\Aviso.exe" /setup:

- Click on “Apply” and then on “OK” § Check the shortcut is functional in “Setup” mode: double click on “Aviso_Setup”. The following

screen should be displayed:

The “Aviso – SETUP” title should be displayed and the above list of Setup functionalities should be available.

STEP 9. Check that there is no “Quantel Medical” file under:

“C:\Users\QM\AppData\Local\VirtualStore\Program Files(x86)\” In case there is a “Quantel Medical” file: delete it.

STEP 10. Restart the computer: check that all newly created shortcuts are functional and that all

data are available in the AVISO / AVISO S software.



NOTES:

1) It is strongly advised to record DICOM and EMR parameters before changing computer. Indeed, when changing computer, the DICOM and EMR functions will not be activated anymore after software installation on the target computer. To re-activate those functions, it is necessary to recalculate the keycode and re-adjust the software parameters. Please contact Quantel Medical to recalculate your keycode.

2) With a 64-bits computer, the AVISO / AVISO S software can absolutely not be installed under “C:\Program Files\” anymore because Windows will always put it by default under “C:\Program Files(x86)\”.

This is the reason why in the above procedure the “Quantel Medical\Aviso” file should be manually copied from “C:\Program Files(x86)\” to “C:\Program Files\”. (STEP 3)

3) If the Aviso software has been installed in a directory other than the one by default in the initial computer (other than “C:\Program Files\Quantel Medical \Aviso “); then, in the target computer, the Aviso software should be installed under the same location with same directory name. As an example: if the Aviso software has been installed under “C:\Quantel Medical\Aviso” in the initial computer, it is mandatory to re-install it under “C:\Quantel Medical\Aviso” in the target computer.

4) Uninstalling the Aviso software via “Program and functionalities / Program files and features” functionalities will delete the Aviso software from “C:\Program Files (x86)\Quantel Medical\Aviso”, but will not delete the version located under “C:\Program Files\Quantel Medical\Aviso”. Then, to definitively delete the software version in the target computer, the Aviso directory will also have to be suppressed manually from “C:\Program Files\Quantel Medical\Aviso”.

5) Do not uninstall the Aviso software via “Program and functionalities / Program files and features” functionalities. Indeed, the Active X will unregister and the software version located under “C:\Program Files\” will not work anymore (the software will not launch and no message will be displayed).

6) The above procedure is identical for the Aviso and Aviso S software: only replace Aviso by Aviso S.

7) As a reminder, under Windows 8, it is not possible to have a single database for several Windows sessions because Windows 8 will always virtualizes data so that there are not accessible under “C:\Program Files” or “C:\Program Files (x86)” but are instead always located under: “C:\Users\QM\AppData\Local\VirtualStore\Program Files”.

8) With Windows 7 UAC ON and Windows 8: never copy the Data and Cineloop folders under: “C:\Program Files\Quantel Medical\Aviso”, otherwise the new saved exam(s), Data or Cineloop files(s) will be created under: “C:\Users\QM\AppData\Local\VirtualStore\Program Files”. As a consequence, part of the data will be localized under “C:\Program Files\Quantel Medical\Aviso”, while the other part of the data (corresponding to the new exam(s)) will be localized under “C:\Users\QM\AppData\Local\VirtualStore\Program Files”. Data will be separated into two different folders and it will not be possible to re-integrate them into a common file. As a conclusion, with Windows 7 UAC ON and Windows 8: all data should be copied under: “C:\Users\QM\AppData\Local\VirtualStore\Program Files” (as mentioned STEP 4).

9) When wanting to upgrade / update the software / database, it is recommended to do it in the initial computer (32-bits) before transfer to the new computer (64-bits). If this is not the case, it might be impossible to transfer data. Follow the service manual indications given Section 13 – Database management to update the database depending on the software version (1.xx to 2.xx, then 2.xx to 3.xx and so on). If the initial computer is not operational to upgrade / update the software / database, it is advised to restart with a brand new database. It may also be possible to use an other operational 32-bits computer, but data will have to be transferred.



10) If the initial computer has several Windows sessions with the UAC ON and if the Aviso is used in each session: it is then necessary to transfer the Aviso database of each session to the target computer. Caution: on the target computer, the Windows sessions will have to be created with the exact same names as the initial computer session names. If this is not the case, the data corresponding to each session will not be accessible on the target computer. Check that the software is installed with each Windows session and that data are accessible in each Windows session.

11) Virtualized data keep the same database path storage location that they are located under: “C:\Program Files\”, or under “C:\Users\QM\AppData\Local\VirtualStore\Program Files”; In both cases, the storage path for the database is: “C:\Program Files\Quantel Medical \Aviso\Data\... “



13.6. AVISO / AVISO S database “behavior” when choosing folder for installation

During the installation process, the user has to” Select the Installation folder for the AVISO / AVISO S software” as shown in the example below:

Depending of the chosen location for installation, the database behavior will be different as explained below:

WITH WINDOWS SEVEN OPERATING SYSTEM WITH WINDOWS EIGHT OPERATING SYSTEM



13.7. AVISO / AVISO S database “behavior” / with several Windows sessions

WARNING QUANTEL MEDICAL recommends to use only one Windows session. In case two Windows sessions are created, the AVISO / AVISO S database “behavior” will be different if the UAC (User Account Control) is activated or not: 13.7.1. Database behavior with Windows Seven Operating System

UAC ON UAC OFF With the UAC ON : two databases are created and they will be completely different (with different Physician & Patient names, Settings…) for each Windows session. If this configuration is chosen: it will be impossible to merge the databases in the future.

With the UAC OFF: only one database is created and it is the same for every Windows sessions.

NOTE With several sessions, when several users use the AVISO software: it is necessary to switch off the AVISO / AVISO S application and log off / log on to a new session. If not, the module may not be recognized properly.



13.7.2. Database behavior with Windows Eight Operating System

With the UAC ON or OFF : two databases are created and they will be completely different (with different Physician & Patient names, Settings…) for each Windows session. If this configuration is chosen: it will be impossible to merge the databases in the future.

WARNING When under Windows Eight Operating System: never paste data under: C:\Program Files\QUANTEL MEDICAL\AVISO (S) directory. Indeed: two databases would be created: One under: C:\Program Files\QUANTEL MEDICAL\AVISO (S), And the other one under: C:\Users\QM1\AppData\Local\VirtualStore\Program Files\QUANTEL MEDICAL\AVISO (S) (when new scans are saved)



13.8. Suppressing the access to switch “User Account” Precaution to take concerning User Account management: Each time a user wants to log on to his own account on the AVISO / AVISO S computer: he has to log off the current account or close the AVISO / AVISO S application. If this is not done properly, there might be a risk of:

Ø Database conflict: the new Users, Patients and Exams will not be accessible in the already opened session.

Ø AVISO S module management problem: module detection problem or slow image display.

To avoid this kind of problem in case the Users do not follow the recommended above procedure, it might be necessary to suppress the access to switch User Account as follows:

Ø Type “gpedit.msc” in the Start (Search or Run dialog box), Ø Select “Administrative Templates”, Ø Then: “System” and “Logon”, Ø Open “Hide entry points for Fast User Switching”, Ø Select “Enabled”.

Check that “Switch User” is disabled in the “Start” menu

14. AVISO / AVISO S SETUP After having installed the AVISO / AVISO S software on the computer, the “AVISO / AVISO S” shortcut is displayed on the computer desktop. However, another shortcut called “AVISO_setup” can be found in the folder:

C:\Program Files\QUANTEL MEDICAL\AVISO\ (AVISO S)

Close the regular AVISO / AVISO S program and double click on the “AVISO_setup” shortcut. This other shortcut allows the user to access some AVISO hidden features (for service only) that are not available in normal use:

Ø Default biometry mode for a new physician (Probes) Ø Start page message Ø Default IOL Setup Ø Uppercase Patient Last Name Ø Activate threshold line for Tumor Q-I

All those features are available from the “AVISO Setup” main menu, under “Setup”:



14.1. Probes (Resetting Test Block Length to zero) Under “Setup”, select “Probes”. The following window is displayed:

“TEST Block” The Zero (Probe) field at the bottom of the TEST Block window allows the user to reset the “Position of marker #1 in contact” to zero as shown below so that when using the regular AVISO / AVISO S application the Correction appears to be “0” with the correct probe calibration.

Example: After biometry probe calibration, the TEST Block Length measurement is correct when the Correction for the Position of marker #1 in Contact is -0.30mm:

Entering 0.30 in the Zero (Probe) field allows the user to reset the Position of marker #1 in Contact to 0mm:

“Default biometry mode for new physician” is the new physician default display mode.

Display mode explanations: Display mode: D1 (adjustable dynamic):

The markers are positioned at the top of the echoes picks. Displayed Dynamic: 35 dB

Display mode: D2 (fixed and low dynamic at 20dB):

The markers are positioned on the rising edge of the echoes at the threshold level. Displayed Dynamic: 20 dB (more contrasted image)

NOTE It is not advised to use the D2 mode when using the “Contact Technique”.



“D2 Mode DYN” is the D2 dynamic in dB display mode: by default, the value is set to 20 dB.

“Retina Slope test” The default value in this field is 6. It defines the sharpness of the retinal peaks in order to freeze the A-scan when the probe direction is in the visual axis, reaching the macula area. This value means that the slope is raised up by 6 digital points. It appears that the retina slope test of 4 is perfect for physicians using the Prager shell with the immersion technique. This shell holds the probe in its axis and helps to keep it perpendicular to the macula. If the physician is not using the immersion technique, but the contact one, and has difficulties to find the visual axis, the Retina Slope Test should be set to 6. Increasing this value will ease the freezing action.

14.2. Start page message This is used to create a customized message that will be available on the AVISO S first page when the Physician will start the software:

The text area may be used to enter QUANTEL MEDICAL or distributor information (such as name, address and telephone numbers):

The start page message will then be displayed as follows:



14.3. Default IOL In the setup menu, select “Default IOL Setup”. The following screen is displayed:

In this screen, it is possible to personalize the IOL file. Select a reference (IOL 1 to IOL 8) and modify the name and parameter values.

NOTE This list is common to all Physicians. It will be displayed each time a New Physician is created.

14.4. Uppercase Patient Last Name When the Uppercase Patient Last Name option is checked as shown below : data will be entered in uppercase by default in the patient Last Name field.

14.5. Activate threshold line for Tumor Q-I Check / uncheck “Activate threshold line for Tumor Q-I” to display / or not threshold line for Tumor Q-I by default.



15. MODULE SOFTWARE RELEASE Starting from the AVISO / AVISO S Software Version 3.XX , the AVISO / AVISO S module allows the user to differentiate the Biometry icon from the Probeam icon :

Biometry icon Probeam icon A Pro

The AVISO/ AVISO S module upgrade is not mandatory: the AVISO / AVISO S will work correctly without upgrading the module. However it is better, when possible, to upgrade it as it allows the user to differentiate the Biometry icon from the Probeam icon, and thus helps avoiding probe selection inversion that would generate measurement error.

Procedure to install the USB Program:

NOTE The UsbProg file is used to release the module software: please contact QUANTEL MEDICAL Service department or your local distributor to get it.

Step 1 Extract the UsbProg file and run the executable file: Setup.exe. The following screen is displayed:

Select “Next”.



Step 2 The following window is displayed:

Select “Everyone” and then “Next”.

Step 3 The following screen is displayed:

Select “Next”.

Step 4 The following screen is displayed:

Wait for the end of the installation.



Step 5 When the “Installation Complete” screen is displayed: select “Close”.

Step 6 After installation: a shortcut is created under QUANTEL MEDICAL (from the Start menu). Click on this shortcut to open the program:

Check the USB connection between the AVISO / AVISO S computer and module is working: the USB icon should be displayed. Start ON the AVISO / AVISO S module.

Step 7 As Script File: select the FlashBCont102.scr file located under C:\Program Files \QUANTEL MEDICAL \USBProg and then: select “Prog device”.



Step 8 The AVISO / AVISO S module software upgrade progress is displayed on the computer screen:

At the end of the upgrade, the module restarts. Wait until “Prog device” and “Cancel” buttons are activated again. “CRC-OK” is displayed. Then, close the window;

NOTE The icons color information is integrated in the biometry probe parameters USB key. For « old » biometry probes : it may possible that the icons color is not correctly displayed as shown below :

Biometry icon

If this is the case, please contact QUANTEL MEDICAL Service Department with the probe serial number to get the new USB key with correct parameters.



16. HIPAA compliance The Health Insurance Portability and Accountability Act (HIPAA) regulations include elements that focus on securing medical records in order to ensure patient privacy. QUANTEL MEDICAL has implemented the following technical measures to be compliant with the HIPAA regulations:

16.1. Security awareness and training

Regulation Implementation

specification Features implemented Implementation information

164.308(a)(5)(ii)(A)

Security reminders The covered entity must “implement periodic security updates”.

Security updates are controlled by Windows Operating System. Each computer is updated before sending the unit to the customer. When a new software is released; the unit can be updated by authorized people only (who have previously been trained by QUANTEL MEDICAL).

Settings can be adjusted from Windows Operating System Control Panel/ Windows update menu.

164.308(a)(5)(ii)(B)

Protection from malicious software The covered entity must “implement procedures for guarding against, detecting, and reporting malicious software.”

- Windows Firewall parameters are adjusted.

- UAC may be adjusted to the correct level (Medium Level).

- A third party antivirus may be installed, but the IT person who installs this kind of software has to adjust the appropriate parameters and validate that the software does not disrupt the normal functioning of the QUANTEL MEDICAL software.

- Via Windows OS settings, it is possible to lock the access of the memory stick on the USB connectors (the files of the memory stick cannot be read and cannot be accessible).

Firewall & UAC parameters can be adjusted from Windows Operating System Control Panel. (From the time the UAC is changed or Windows sessions are created: QUANTEL MEDICAL data are not located in the same location. Refer to Sections 13.4, 13.5 and 13.6). Never modify the UAC in case exams have already been saved.

164.308(a)(5)(ii)(C)

Log in monitoring The covered entity must “implement procedures for monitoring log-in attempts and reporting discrepancies.”

The Log-in monitoring is controlled by Windows Operating System (audit account login).

- Open the “Local Security Policy” window by typing “secpol.msc” in the “Search Program and Files” field of the Windows Operating System and press “Enter”. Then, select the dedicated properties for local audit policies.

- Or select: “Windows Operating System Control Panel/Administrative tools/Local Security Policies”. Then, select the dedicated properties for audit policies.



164.308(a)(5)(ii)(D)

Password management The covered entity must “implement procedures for creating, changing, and safeguarding passwords.”

This function is controlled by Windows Operating System (User Accounts window / password management).

- Open the “Local Security Policy” window by typing “secpol.msc” in the “Search Program and Files” field of the Windows Operating System and press “Enter”. Then, select the dedicated properties for password policy.

- Or select: “Windows Operating System Control Panel/Administrative tools/Local Security Policies”. Then, select the dedicated properties for password policy.

16.2. Contingency plan



164.308(a)(7)(ii)(A)

Data Backup Plan The covered entity must "establish and implement procedures to create and maintain retrievable exact copies of electronic protected health information."

A backup of the QUANTEL MEDICAL device can be done on network, on DVD or external hard drive, by using the dedicated function; which is located in the software. Third party software may be installed to fill this function.

Select the “Archive database” function located in the SETUP screen of the AVISO / AVISO S software as described in this Service manual (Section 13.3.3 Save the database).

164.308(a)(7)(ii)(B)

Disaster Recovery Plan The covered entity must “establish (and implement as needed) procedures to restore any loss of data.

The procedure to restore lost data is accessible in this unit Service Manual. This recovery procedure can be completed by IT personal or authorized people only (who have previously been trained by QUANTEL MEDICAL). Third party software may be installed to fill this function.

The procedure is given in this Service Manual (Section13 – Database management).



16.3. Access controls



164.312(a)(2)(i)

Unique User Identification The covered entity must “assign a unique name and/or number for identifying and tracking user identity.”

This function may be controlled by the account session of the Windows Operating System. Windows does not allow a user to create two sessions with the same name.

- Open the “Local Security Policy” window by typing “secpol.msc” in the “Search Program and Files” field of the Windows Operating System and press “Enter”. Then, select the dedicated properties for password policy.

- Or select: “Windows Operating System Control Panel/Administrative tools/Local Security Policies”. Then, select the dedicated properties for password policy.

164.312(a)(2)(ii)

Emergency Access Procedure The covered entity must “establish (and implement as needed) procedures for obtaining necessary electronic protected health information during an emergency.”

A dedicated user account may be created and set by the IT person; when the QUANTEL MEDICAL unit is installed and set. This is the responsibility of the IT person to decide the emergency access

procedure: refer to the dedicated chapter of the HIPAA for more details and refer to the authentication policy of the hospital.

164.312(a)(2)(iii)

Automatic Logoff The covered entity must “implement electronic procedures that terminate an electronic session after a predetermined time of inactivity.”

This function may be controlled by the Windows operating system and set by the IT person.

- Open the “Local Security Policy” window by typing “secpol.msc” in the “Search Program and Files” field of the Windows Operating System and press “Enter”. Then, select the dedicated properties for account lockout policy.

- Or select: “Windows Operating System Control Panel/Administrative tools/Local Security Policies”. Then, select the dedicated properties for or account lockout policy.

Automatic logout sessions may involve USB detection problems. In this case, the AVISO / AVISO S unit has to be switched off and restarted.

164.312(a)(2)(iv)

Encryption and Decryption The covered entity must “implement a mechanism to encrypt and decrypt electronic protected health information.”

Third party software may be installed to fill in this function.

Such as Symantec Endpoint Encryption.



16.4. Audit controls



164.312(b)

Requires auditing of information system The covered entity must “implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information.”

This function may be controlled by the Windows Operating System and set by the IT person (by using the Windows Audit Policies).

- Open the “Local Security Policy” window by typing “secpol.msc” in the “Search Program and Files” field of the Windows Operating System and press “Enter”. Then, select the dedicated properties for local audit policies.

- Or select: “Windows Operating System Control Panel/Administrative tools/Local Security Policies”. Then, select the dedicated properties for audit policies.

16.5. Integrity



164.312(c)(2)

Mechanism to Authenticate Electronic Protected Health Information The covered entity must “implement electronic mechanisms to corroborate that electronic protected health information has not been altered or destroyed in an unauthorized manner.”

A checksum is used to check that the data and images are not corrupted, modified, altered or destroyed. If one image is in the above situation, this one is not displayed.



16.6. Person or entity authentication



164.312(d)

The covered entity must “implement procedures to verify that a person or entity seeking access to electronic protected health information is the one claimed.”

This is the responsibility of the IT person to decide the level of protection (by using password, token…): refer to the dedicated chapter of the HIPAA for more details and refer to the authentication policy of the hospital.

16.7. Transmission security

Regulation Implementation specification

Features implemented Implementation information

164.312(e)(2)(i)

Integrity Controls The covered entity must “implement security measures to ensure that electronically transmitted electronic protected health information is not improperly modified without detection until disposed of.”

The Integrity Controls depend upon the network configuration and to the authentication policy of the hospital. Third party software may be used to fill in this function.

164.312(e)(2)(ii)

Encryption The covered entity must “implement a mechanism to encrypt electronic protected health information whenever deemed appropriate.”

Third party software may be installed to fill in this function.



17. FUSE REPLACEMENT

WARNINGS & CAUTIONS

· Disconnect the power supply and USB cable before cleaning the unit case. · Only use a damp cloth for cleaning the AVISO / AVISO S unit. Do not use any solvent or alcohol. · The AVISO / AVISO S touch-screen is fragile. · Disconnect the power cord before any intervention on the unit.

Fuse replacement: Fuse specifications:

· Glass fuses · 1 AT - 250V · 5 x 20 mm

Documents

AVISO User Manual: Introduction - ugap.fr ... USER MANUAL TERMS AND SAFETY SYMBOLS ... • Any adjustment and calibration procedure described in this manual shall be performed by QUANTEL