POCKET II SERVICE MANUAL - ugap.fr question regarding the installation or the use of the Pocket II system should be directed to the QUANTEL MEDICAL Service Department or to a

PACHYMETER ECHOGRAPH

OCTOBER 2012

POCKET II SERVICE MANUAL

11, rue du bois joli - CS 40015

63808 Cournon d’Auvergne Cedex FRANCE

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

E-mail : [email protected] Site web: www.quantel-medical.com

2003

Directive 93/42/EEC

http://www.quantel-medical.com/

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

© 2012 Quantel Medical All rights reserved Axis Nano Service Manual (Ref: XE PCK2 MT AN) October 10, 2012

2003

Directive 93/42/EEC



CONTENTS

1. INTRODUCTION ................................................................................................ 1 2. SERVICE MANUAL TERMS AND SAFETY SYMBOLS ................................... 1

3. WARNINGS & CAUTIONS ..................................................................... 1 4. POCKET II & PACHYMETRY PROBE TECHNICAL SPECIFICATIONS ......... 3 5. POWER SUPPLY .............................................................................................. 3 6. LABELS ............................................................................................................. 5

6.1. Rear side ............................................................................................................................ 5

6.2. Upper side .......................................................................................................................... 6

6.3. Lower side ......................................................................................................................... 7

6.4. Left side ............................................................................................................................. 8

6.5. Footswitch ......................................................................................................................... 8 7. OVERALL BLOCK DIAGRAM .......................................................................... 9 8. INSTRUMENT BOX ......................................................................................... 10

8.1. Material ............................................................................................................................. 10

8.2. Dimensions and weight .................................................................................................. 10 9. ACCESSORIES AND SPARE PARTS ............................................................ 11 10. MAINTENANCE ............................................................................................... 11

10.1. Changing batteries.......................................................................................................... 11

10.2. Pachymetry probe calibration ....................................................................................... 12 a. Calibration procedure .................................................................................................... 12 b. Operating test ................................................................................................................ 13

10.3. Opening the pocket to unit to access the acquisition (CPU) board .......................... 15 11. POCKET II SOFTWARE INSTALLATION ....................................................... 16

11.1. Accessories to load the new software version ............................................................ 16

11.2. Procedure to update the unit with a new software version ........................................ 16

11.3. Function keys and possible selections ........................................................................ 20

11.4. Troubleshooting .............................................................................................................. 20 12. ERROR MESSAGES ....................................................................................... 21


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1. INTRODUCTION This service manual gives Pocket II technical information such as:

- The technical specifications; - Power supply information; - The accessories and spare parts; - Servicing / disassembling the unit; - Calibration; - Software installation.

2. SERVICE 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 WARNINGS • Federal USA law restricts this device to sale by or on order of a physician. • No modification of this equipment is allowed. • Any printer or computer must be disconnected from the Centronics socket, if

the connected accessories are not separated by an insulator (in accordance with the standards IEC 60601-1 and IEC60950). Furthermore the installation of accessories / insulators must be carried out or verified by the responsible authorities according to clause 16 IEC 60601 - 1.third edition).

• Servicing of the unit must only be performed by Quantel Medical technicians or by technicians approved by Quantel Medical (for local distributors).

• The unit must be checked every year by a Quantel Medical technician or by technicians approved by Quantel Medical (for local Distributors).

• Be careful not to compress the cornea when recording measurements because measurements may be altered.


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CAUTIONS • 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.

• For safety reasons, Quantel Medical considers the Pocket II CPU board as a whole part: defective CPU boards should be returned to Quantel medical as a whole part for replacement.

• If the device is not used for a long period of time, it is highly recommended to remove the batteries from their compartment.

• Precautions to take concerning wastes and elimination of device and accessories: This product complies with the WEEE Directive (2002/96/EC) marking requirements. The Pocket II is an electrical / electronic product and must not be discarded with domestic household wastes.

Do not dispose with domestic household wastes!

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

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

mailto:[email protected]

mailto:[email protected]


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4. POCKET II & PACHYMETRY PROBE TECHNICAL SPECIFICATIONS

5. POWER SUPPLY The POCKET-II equipment requires four 1,5V AA (LR6) batteries in order to operate. An optional external power supply with the following specifications can be used to replace the batteries:

WARNING

Only use and connect the external power supply module with reference Ref. FW7333SM/09 as specified in the table above.

POCKET II Class II (isolation) Type BF (isolated applied part) Display 16 characters Measurement range 200-999 microns Accuracy ±5 microns Size 200x100x45mm Weight 450g Maximum height for use 2000m Programmable logic device (PLD) clock 32MHz Microprocessor clock 8MHz

PROBE (P1) PZT Ceramic frequency 20MHz Focus 0.5mm to 2mm from probe’s tip Tip diameter 1.2mm Angle 45 degrees

EXTERNAL POWER SUPPLY SPECIFICATIONS Manufacturer FRIWO No de pièce : FRW 7333 SM/09 Output voltage 9V ±5% Output current 800mA Input voltage 100 Vac ±10% – 240 Vac ±10% Input current 0.2A à 100Vac / 0.08A à 240Vac Input frequency 50-60Hz Efficiency 70%typ. at full load Operating temperature 0°C to 40°C Storage temperature -40°C to +70°C Humidity 5% to 95%, non-condensing Safety specifications:

• Protection level • Conform to the standards

II IEC 60601 and UL 60601

Marking CE


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NOTE The POCKET-II equipment consumes very low current and cannot generate any significant EMI effect. The POCKET-II equipment is powered by direct current (DC) voltage.

CAUTION

The POCKET II complies with the EN 60601-1-2 (EMC). Make sure all the surrounding devices comply with this standard. Connect the optional external power supply to the connector positioned on the upper left side of the POCKET-II instrument:

CAUTION Do not remove the batteries before connecting the external power supply (in order to safeguard the configuration data)

Connect the optional external power supply to this connector.


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6. LABELS 6.1. Rear side

Label Description

Identification label

1

1


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6.2. Upper side

Power supply label

Printed plate symbols

Symbols Description

Parallel port for printer

Serial port to PC

NOTE The PC must be in accordance with EN 60950 standard

External power supply

1

2

1

2

9V

500mA


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Identification label

Symbols Description

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

General warning sign ISO 7010-W001 General

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

For indoor use only. IEC 60417-5957

Electrical/electronic equipment in accordance with the Directive 2002/96/EC (WEEE) Do not dispose with domestic household wastes. EN 50419

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

6.3. Lower side

Label Description

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

1

1


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6.4. Left side

Federal law for USA label

6.5. Footswitch

Label

Symbols Description

IP44 : - Protection against the penetration of foreign solid bodies of diameter Ø ≥ 1 mm). - Protection against splashing water.

Electrical/electronic equipment in accordance with the Directive 2002/96/EC (WEEE) Do not dispose with domestic household wastes. EN 50419

1

1

1

1


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7. OVERALL BLOCK DIAGRAM


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8. INSTRUMENT BOX 8.1. Material

The box is in ABS plastic in accordance with the UL94V0 standard.

8.2. Dimensions and weight

Width: 100 mm Depth: 200 mm

Height: 45mm Weight: 460g

Front panel Rear panel


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9. ACCESSORIES AND SPARE PARTS

Basic configuration Pachymetry probe (XEAAAPRBPK) 4 batteries (type LR6) Integrated test block User manual Probe holder

Spare parts Pocket II plastic box (XEPOCBOIT2) Pocket II front panel + test block (XEPOCLEXAN2) Pocket II CPU board (XEPOCCPU2) Pocket II LCD screen and board (XEPOCLCD2) Pocket II transportation case (XEPOCVALISE2)

10. MAINTENANCE 10.1. Changing batteries

It is necessary to replace batteries when the following message is displayed: “Low Bat!”

Procedure for battery replacement:

Unscrew the two large headed metal screws on the underside of the Pocket II; Remove the back panel of the battery compartment; Remove the 4 old batteries; Install the 4 new batteries (LR6 1.5V) respecting the sign of the polarities; Place and screw the back panel.

NOTE During the batteries replacement, the unit should have retained the configuration. Calibration is not necessary.

Optional accessories Footswitch (XEAAAPED ) External power supply (XEPOCALIM)

2 large headed metal screws


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10.2. Pachymetry probe calibration

WARNING Calibration should be done each time a new pachymetry probe is connected to the Pocket II unit or on a regular basis for maintenance.

The calibration is safeguarded in the memory by an internal battery. If the data is lost, for any reason, the program will reset to the default configuration.

a. Calibration procedure

Firstly, ensure that the probe is connected and the tip is clean and dry.

a) Press button 3s;

Simultaneously press these buttons 3s: ; Speed selection is displayed ;

Press button ; “Cal unp XXXX XXXX” is displayed;

Simultaneously press these buttons: ; The message “unplug the probe” is displayed; Unplug the probe;

Press ; Cal unp with the new parameters is displayed; This step a) should be repeated

three or four times until values are stable: ± 10.

b) Press ; “Cal wat XXXX XXXX” is displayed;

Simultaneously press these buttons: ; The message “probe in water” is diplayed ; Plug the probe on the Pocket II and put it in a glass of water at 30°C as shown

below:

Press ;


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Calwat with the new parameters is displayed; This step b) should be repeated three or four times until values are stable: ± 10.

c) The calibration is done:

In order to save this calibration press 3s. NOTE New Pocket II units are delivered already calibrated with its probe. It is not necessary to recalibrate it.

b. Operating test The measurement acquisition may be checked with the plastic test-block:

1- Moisten the probe extremity with water and place it perpendicular on the Pocket II test-block as indicated below:

CAUTION Do not put water directly on the test-block.

2- Go to the “MEASURE” mode. Unfreeze by pressing “Meas” button or the footswitch.

The acquisition should be fast: if necessary, slightly change the orientation of the probe to obtain an acquisition. You hear a repetitive beep as long as the probe is not positioned correctly.

You must hold the probe perpendicular to the test-block as shown on the following figure:

Test block on the Pocket II


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NOTE By default, 5 measurements are recorded.

3- Results of the test: Important check: if the probe position is correct, the standard deviation, corresponding to the series of measurements, must be close to ±20 microns and be equal to the test-block thickness value. NOTE Some parameters are likely to affect test-block measurement:

The possible erosion of the test-block; The variation of the thickness with the ambient temperature; Possible dust; The difficulty of placement.

Because of these parameters, the accuracy of the test-block measurement can only be within ±20 microns around the test-block given value. If you suspect any problem, please call for Service (Quantel medical or local distributor).

AVERTISSEMENT Any system repair must only be performed by Quantel Medical technicians or other technicians approved by Quantel Medical (local distributors).


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10.3. Opening the pocket to unit to access the acquisition (CPU) board

The Pocket II plastic box is composed of two parts:

1/ Unscrew the two large headed metal screws on the underside of the pocket II unit and remove the back panel that protects the battery compartment:

2/ Unscrew the four screws as indicated below to remove the bottom part of the Pocket II plastic box:

CAUTION

In case the Pocket II unit is not used for a long period of time: it is recommended to remove the batteries.

NOTE Schematic diagram for treatment card reference: REF.: 3 101 0109 Rev B; Treatment card layout reference: REF.: 4 152 0109 Rev A.

4 screws

2 large headed metal screws


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11. Pocket II software installation 11.1. Accessories to load the new software version

• RS232 cable and a cable adaptor • CD rom including :

o The emulator program “Quantelprog.exe” o The last Pocket-II software version “Pock104.p”

NOTE An RS232 to USB converter (with driver) can be used in case the PC does not have RS232 serial port.

11.2. Procedure to update the unit with a last software version

a) Connecting the Pocket-II to the computer

The COM port is used to transfer information between the PC and Pocket II unit: the software version is loaded from the computer to the pocket II flash memory.

• Connect the 9 pins Sub-D RS232 connector to the computer: on any available port (COM1 or others).

• Connect the 6 pins mini-DIN male connector of the provided adaptor cable to the Pocket-II.

• The last software version is loaded from the computer into the Pocket II unit Flash memory.


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b) Installing the new software

• Open the file “Quantelprog.exe” (from provided CD-Rom):

The following screen is displayed:

• Check the Serial port parameters in “Setup / Port” (or press F9) :

NOTE In case the selected Com# is not available: an error message is displayed when pressing “OK”. If so, try an other Com# and press OK.


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c) Select the path to the last software file location

Load programming file: “Filename.p”

Press this button to select the new software file location: (example: A:\POCK104.P).

The following box is displayed:

Check the “filename.p” location: search the file with the Select key. Press « OK » to validate. d) Ready to transfer

Switch ON the Pocket-II (press during 3s on the “CLEAR” button: ). The following screen is then displayed:

Select the [Space] bar on the PC keyboard and press the “Meas.” button:

on the Pocket-II simultaneously until the following screen is displayed:


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e) Load the new software

Press the following key and the transfer procedure should automatically start:

The following messages will be displayed:

f) Installation is completed

The installation is done when the following screen is displayed:

g) Check the new software is correctly installed

• Remove the batteries or disconnect the power supply to completely reset the Pocket-II.

• Disconnect the RS232 cable. • Re-install the batteries or re-connect the power supply.

• Press on the “CLEAR” button during 3s :

The following messages should be displayed on the Pocket II: “QUANTEL MEDICAL” “VERSION 1.04” The Pocket-II is ready to work with the last software version 1.04. NOTE The previous configuration and calibration are preserved.


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11.3. Function keys and possible selections

Key to locate and select the new software version file for installation. The file name suffix is : “.p” By default the directory is set to A:\.

Key to start the new software transfer.

Key to clean the screen: any data is erased.

Key to print the data displayed on the screen.

Key to display the following message on the screen:

11.4. Troubleshooting

a) No dialogue between the unit and the computer • Check the RS232 cable is correctly connected to the right connector of the

unit. • Check the cable is correctly connected to the computer: serial Com# port. • Check the selections in the: Setup / Port (F9 key). • Check all data are selected as follows:


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When pressing “OK”, the program will display a message if the selected port cannot be opened: Error message: “Error port not open!” If so, change the Com# and try again until the program does not display any error message.

b) File name not found The software does not find the file to upgrade, when this key is selected:

Press this button to select the programming file: “filename.p”

The following screen is displayed:

Check the “filename.p” location: search the file with the Select Key.

12. Error messages

Message Explanation

Bad measure No measurement acquisition has been possible during the available 45 seconds. Press “Meas” button or the footswitch to start a new acquisition.

Buffer is full The Pocket II memory is full. Print several saved files to empty memory.

ID already use The identifier ID you are trying to validate is already in use. Change the ID for the new file.

Print. not ready The printer is not ready. Check the printer is connected and ready to receive data.

Printer error The printer is selected by default. Check the state of your printer.

Low Bat! Batteries are worn-out. To replace batteries, refer to:

Documents

POCKET II SERVICE MANUAL - ugap.fr question regarding the installation or the use of the Pocket II system should be directed to the QUANTEL MEDICAL Service Department or to a