Iman QS

48
ASA S.r.l. - Via A. Volta, 9 - 36057 ARCUGNANO (VI) - ITALIA SERVICE MANUAL File: SM043EN00.DOC Rev. : 00 del : 13/02/2014 Magneto QS Prepared Controlled Approved

description

Dispositivos medicos

Transcript of Iman QS

  • ASA S.r.l. - Via A. Volta, 9 - 36057 ARCUGNANO (VI) - ITALIA

    SERVICE MANUAL File: SM043EN00.DOC

    Rev. : 00 del : 13/02/2014

    Magneto QS

    Prepared Controlled Approved

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    CONTENTS pag.

    1 NON-RESPONSIBILITY ..................................................................................................... 1-12 INFORMATION REQUIRED BY ASA SERVICE CENTRE ................................................ 2-13 SAFETY STANDARDS AND CLASSIFICATION ............................................................... 3-13.1 Introduction ...................................................................................................................................... 3-13.2 Classification of the device............................................................................................................... 3-33.3 Preventive labels .............................................................................................................................. 3-43.4 Prevention against explosion and fire .............................................................................................. 3-44 MAINTENANCE AND ADJUSTMENTS ............................................................................. 4-55 DEVICES SELF-DIAGNOSIS ............................................................................................ 5-65.1 Mains and other panel led ................................................................................................................ 5-65.2 WARNINGS ..................................................................................................................................... 5-65.2.1 Emission warning light ................................................................................................................. 5-65.2.2 Warning tone ................................................................................................................................ 5-66 GENERATORS COMPONENTS LAYOUT ........................................................................ 6-77 GENERAL CONNECTION ................................................................................................. 7-98 DEVICE REPLACING AND CHECKING PROCEDURES ................................................ 8-108.1 General instructions ....................................................................................................................... 8-108.2 Removing the top of the devices cover ......................................................................................... 8-118.3 Replacing PMT/Easy electronic boards ......................................................................................... 8-128.4 Replacing Interface Board.............................................................................................................. 8-138.5 Replacing protective side shell ...................................................................................................... 8-148.6 Replacing foot ................................................................................................................................ 8-158.7 Replacing fan ................................................................................................................................. 8-168.8 Replacing display frame ................................................................................................................. 8-178.9 Replacing lamp board .................................................................................................................... 8-188.10 Replacing power board .................................................................................................................. 8-198.11 Replacing Cylinder connectors (Neutrik) ....................................................................................... 8-208.12 Replacing motorized bed connectors ............................................................................................. 8-208.13 Replacing Flexa connectors ........................................................................................................... 8-218.14 Replacing Power module ............................................................................................................... 8-218.15 Replacing the top of the devices cover ......................................................................................... 8-228.16 Updating Magneto QS software ..................................................................................................... 8-238.16.1 USB To Serial Converter Cable Driver Installation for 64bit windows systems ......................... 8-238.16.2 Usb To Serial Converter Cable. Driver installation for other systems ....................................... 8-248.16.3 SERIAL PORT CONFIGURATION ............................................................................................ 8-248.16.4 CONNECTION SETUP .............................................................................................................. 8-258.16.5 CONFIGURATION OF HFD PROGRAM ................................................................................... 8-25

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    8.16.6 PROGRAM PHASE ................................................................................................................... 8-269 FLEXA CHECKING PROCEDURES ................................................................................ 9-2710 CYLINDER CHECKING PROCEDURES ....................................................................... 10-2811 TROLLEY REPLACING PROCEDURES ....................................................................... 11-2912 RECOMMENDED REGULAR CHECKS ........................................................................ 12-3413 SPARE PARTS .............................................................................................................. 13-3514 TROUBLESHOOTING .................................................................................................... 14-3714.1 Device is not working ................................................................................................................... 14-3714.2 Display is not working .................................................................................................................. 14-3714.3 Motorized bed not recognized ..................................................................................................... 14-3714.4 Flexa not working ........................................................................................................................ 14-3714.5 Cylinder not working .................................................................................................................... 14-3715 NOTES AND PERSONAL REMARKS ........................................................................... 15-38

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    SOMMARY OF FIGURES

    Figure 5-1 : Operator panel .................................................................................................................. 5-6Figure 6-1 : Rear view .......................................................................................................................... 6-7Figure 6-2 : Frontal view ....................................................................................................................... 6-7Figure 6-3 : Internal view ...................................................................................................................... 6-8Figure 7-1 : General Wiring .................................................................................................................. 7-9Figure 13-1 : Exploded view ............................................................................................................. 13-35

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    SUMMARY OF TABLES

    Table 3-1 : Applied safety standards .................................................................................................... 3-1Table 5-1 : Main and other panel led .................................................................................................... 5-6Table 9-1 : Flexa resistance values .................................................................................................... 9-27Table 10-1 : Cylinder resistance values ........................................................................................... 10-28

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    1 Non-responsibility

    ASA s.r.l. shall not be held responsible for damage to persons or objects due to alterations, inappropriate

    maintenance, incorrect conditions of caring for or using the device or failure to comply with any of the

    instructions contained in this manual.

    ASA s.r.l. is not responsible for direct or collateral effects caused by therapeutic use of the system. These

    effects are the direct responsibility of medical staff performing the treatments.

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    2 Information required by ASA Service Centre

    To guarantee the components traceability and to improve the post-sale service, remembers that, in case

    of fault, malfunction or maintenance, it is necessary to contact the ASA service center and to

    communicate the followings data:

    Model of the device; Its serial number; Customer name and address (or company name where applicable); Description of the fault or malfunction; Description of action taken to solve the problem; List of components replaced or repaired complete with codes and serial numbers; Details of the purchase (delivery note or invoice, number and date). For any enquiries regarding our device or other needs, we can be contacted at:

    ASA s.r.l.

    Via Volta, 9

    I 36057 Arcugnano (VI)

    Tel.+39-0444-289200

    Fax +39-0444-289080

    www.asalaser.com

    email [email protected]

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    3 Safety standards and classification

    3.1 Introduction

    ELECTRO MEDICAL DEVICES must guarantee a high level of protection to PATIENTS, OPERATORS and to third

    parties. To guarantee maximum safety, the DEVICE was designed to comply with international technical

    standards and was produced observing production process quality criteria in compliance of ISO 13485

    and EN ISO 9001 standards. The DEVICE satisfies the safety requirements specified under the standard

    indicated in the following table.

    Table 3-1 : Applied safety standards

    STANDARD TITLE

    Directive 93/42/EEC Concerning medical devices

    Directive 2002/96/EEC Waste Electrical and Electronic Equipment

    EN 60601-1 Medical electric equipment Part 1: General requirements for safety

    EN 60601-1-2 Medical electric equipment Part 1: General requirements for safety 2 - Collateral Standard: Electromagnetic compatibility - Requirements and tests

    EN ISO 14971 Medical devices - Application of risk management to medical devices

    EN 62304 Medical device software - Software life-cycle processes

    EN 60601-1-6 Medical electrical equipment -- Part 1-6: General requirements for safety - Collateral standard: Usability

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    3.2 Classification of the device

    According to the construction precautions adopted, the appliance is classified as follows:

    Protection against electrical hazards: Class I (EN 60601-1); Protection against direct and indirect contacts: type B applied part (EN 60601-1); Level of protection against the penetration of water: IPX0 or ordinary equipment (EN 60601-1); Sterilisation and disinfection methods permitted by the manufacturer: NOT STERILE; For

    disinfection, consult the "Maintenance" section of this instructions manual.

    Level of safety in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide: The Appliance is NOT suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide.

    Conditions of use: continuous operation (EN 60601-1).

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    3.3 Preventive labels

    The device, flexa applicators, cylinders and beds feature warning labels listing the systems identification

    data and its general characteristics as well as drawing the OPERATORs attention to how hazardous

    situations can be avoided.

    WARNING

    WARNING LABELS MUST BE KEPT IN A GOOD STATE OF REPAIR AND REPLACED IMMEDIATELY IN THE EVENT OF WEAR OR DAMAGE

    For further details on

    installing the device labeling electrical, mechanical, environmental, and electromagnetic emission characteristics mechanical and electrical safety

    refer to the instructions given in the installation and operating manual.

    3.4 Prevention against explosion and fire

    Flammable or combustible chemical products such as methacrylate resins or plastics may catch fire if

    exposed to laser radiation. Do not aim laser radiation at these objects.

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    4 Maintenance and adjustments

    The device has been designed and manufactured for safe use and easy maintenance. It is advisable to

    clean the device and accessories regularly (every day or once a week). The generating device, and

    accessories can be cleaned with a clean cloth dampened with non-alcoholic disinfectant detergents. Dry it

    afterwards with a clean cloth or synthetic leather.

    Do not insert any type of material or device into the grille of the fan in the backside of the device.

    Check the power supply cable and in the event of wear replace with a new one as soon as possible; this

    can be ordered from ASA.

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    5 Devices self-diagnosis

    5.1 Mains and other panel led

    LIGHT TYPE OF LIGHT MEANING MAINS green light Mains power on: light on - appliance powered; off - appliance not powered

    ON green light Appliance on indicator: light on- appliance working START STOP green light

    Appliance status indicator: light on when performing treatment (even if in pause)

    PAUSE yellow light Pause status indicator: light on - appliance in pause CH1 blue light CHANNEL 1 status indicator: flashing light - channel in emission CH2 blue light CHANNEL 2 status indicator: flashing light - channel in emission

    Table 5-1 : Main and other panel led

    Figure 5-1 : Operator panel

    5.2 WARNINGS

    5.2.1 Emission warning light

    The red emission warning light flashes when treatment is about to begin and shines steady while

    treatment is in progress and the accessories are emitting a magnetic field.

    5.2.2 Warning tone

    The appliance is fitted with a buzzer signalling the start, interruption or end of treatment. The buzzer also

    sounds when the solenoid moves on the powered bed.

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    6 Generators components layout

    Figure 6-1 : Rear view

    Figure 6-2 : Frontal view

    Power Supply connector

    START/STOP

    CH 2A/1 CH 2A/2 CH 2B/1 CH 2B/2

    Fuses

    Bed 2A Bed 2B

    CH 1

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    Figure 6-3 : Internal view

    PMT/EASY board D500066#/67#

    Power board M3160054

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    7 General Connection

    Figure 7-1 : General Wiring

    Elements followed by * are only on F9020113; D500066# is on F9020113 and D500067# on F9020112

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    8 Device replacing and checking procedures

    ATTENTION In order to avoid personal injury, do not touch the exposed connections or components while the device is

    connected to the mains power supply. Disconnect the device from the mains power supply before

    carrying out the activities described in this section.

    8.1 General instructions

    1) Identify the component to be removed referring to figures at Chapter 6 and to exploded view drawing

    and table at Chapter 13;

    2) Read the paragraph TOOLS REQUIRED: in order to avail of the list of equipment and/or instruments necessary for completing the procedure;

    3) Once repairs are done, execute the electric safety test.

    In order to access the internal components of the device, follow procedures 8.2.

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    8.2 Removing the top of the devices cover

    TOOLS REQUIRED:

    2.5 mm Hexagon key.

    PROCEDURE:

    1) Unscrew the 4 screws securing the devices cover

    2) Lift the devices cover;

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    8.3 Replacing PMT/Easy electronic boards

    TOOLS REQUIRED:

    2.5 mm Hexagon key.

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Disconnect Channel 1, Channel 2, motorized bed, lamp, power in, fan and DB9 cables

    3) Unscrew 5 screws

    4) Replace electronic boards group

    5) Follow procedure backwards

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    8.4 Replacing Interface Board

    TOOLS REQUIRED:

    2.5 mm Hexagon key.

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Remove display frame (see paragraph 8.8)

    3) Unscrew 5 screw from display

    4) Replace interface board

    5) Follow procedure backwards

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    8.5 Replacing protective side shell

    TOOLS REQUIRED:

    2.5 mm Hexagon keys.

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Pull plastic barbed rivets

    3) Replace side shell

    4) Follow procedure backwards

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    8.6 Replacing foot

    TOOLS REQUIRED:

    3 mm Hexagon keys.

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Remove rubber foot

    3) Unscrew screw holding nut from other side

    4) Replace plastic foot

    5) Follow procedure backwards

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    8.7 Replacing fan

    TOOLS REQUIRED:

    2.5 mm Hexagon keys

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Unplug fun cable

    3) Cut and remove four rubber supports of the fan

    4) Replace fan with own cable

    5) Fix new fan with new rubber supports (M1090124)

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    8.8 Replacing display frame

    TOOLS REQUIRED:

    2.5 mm Hexagon keys

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Press the inner part of plastic black rivets from above and remove them

    3) Remove display frame

    4) Place new display frame on devices cover and fix it with rivets

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    8.9 Replacing lamp board

    TOOLS REQUIRED:

    2.5 mm Hexagon keys

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Unscrew two screw

    3) Remove lamp board

    4) Place new lamp board

    5) Close the top of the devices cover

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    8.10 Replacing power board

    TOOLS REQUIRED:

    2.5 mm Hexagon keys

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Unscrew 4 screw Magneto board

    3) Replace power board

    4) Follow procedure backwards

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    8.11 Replacing Cylinder connectors (Neutrik)

    TOOLS REQUIRED:

    2 mm Hexagon keys

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Unplug respective two fastons form backside of connector

    3) Unscrew two front screws

    4) Replace connector

    5) Follow procedure backwards

    8.12 Replacing motorized bed connectors

    TOOLS REQUIRED:

    2 mm Hexagon keys

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Unplug respective connectors from Magneto board

    3) Unscrew four front screws

    4) Replace connector with its own cable

    5) Follow procedure backwards

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    8.13 Replacing Flexa connectors

    TOOLS REQUIRED:

    Particular keys

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Unplug respective connectors from Magneto board

    3) Unscrew metal ring form backside of connector (use tool)

    4) Replace connector with its own cable

    5) Follow procedure backwards

    8.14 Replacing Power module

    TOOLS REQUIRED:

    2 mm Hexagon keys

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Unplug respective three fastons form backside of module

    3) Unscrew two front screws

    4) Replace module

    5) Follow procedure backwards

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    8.15 Replacing the top of the devices cover

    TOOLS REQUIRED:

    2.5 mm Hexagon key.

    PROCEDURE:

    1) Remove the top of the devices cover (see paragraph 8.2)

    2) Remove display frame (see paragraph 8.8)

    3) Remove lamp board (see paragraph 8.9)

    4) Remove display (see paragraph 8.4)

    5) Replace devices cover

    6) Follow procedure backwards

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    8.16 Updating Magneto QS software

    TOOLS REQUIRED:

    Usb To Serial Converter Cable. ATEN Model: UC-232A Serial RS232 cable, 11.8in length, 9 pin to pin connection type, DB9M-DB9F that means one

    connector its male, one its female.

    Window based PC H8F.program files (CMDIALOG.VBX, H8F.EXE, MSCOMM.VBX, THREED.VBX, VBRUN300.DLL) Latest B039A0##.OBJ file

    PROCEDURE:

    8.16.1 USB To Serial Converter Cable Driver Installation for 64bit windows systems

    1) Download Windows XP Mode with Virtual PC from Microsoft site:

    http://www.microsoft.com/windows/virtual-pc/download.aspx

    2) Install Windows XP Mode with Virtual PC

    3) Open Windows XP Mode with Virtual PC

    4) Open http://www.aten.com/products/productItem.php?model_no=UC232A

    5) Select Resource tab

    6) Select Software & Driver Tab

    7) Download XP 32bit drivers

    8) Extract Zip file

    9) Execute extracted file and follow on screen messages

    10) Insert USB to Serial

    11) From the top Virtual PC menu bar select USB, than Connect USB-Serial Controller and follow on

    screen messages

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    8.16.2 Usb To Serial Converter Cable. Driver installation for other systems

    1) Open http://www.aten.com/products/productItem.php?model_no=UC232A

    2) Select Resource tab

    3) Select Software & Driver Tab

    4) Download driver for your system

    5) Extract Zip file

    6) Execute extracted file and follow on screen messages

    7) Insert USB to Serial and follow on screen messages

    8.16.3 SERIAL PORT CONFIGURATION

    1) Open device manager (at a command prompt, in the Start Search box, or in the Run box, type the

    following command: mmc devmgmt.msc

    2) Select Port (COM and LPT)

    3) Right mouse button on USBtoSerial Port

    4) Select properties

    5) Select port installation

    6) Select Advanced

    7) Select COM port

    8) Set COM2 and press OK (if COM2 is already used set COM1)

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    8.16.4 CONNECTION SETUP

    Set up connection as shown in figure

    8.16.5 CONFIGURATION OF HFD PROGRAM

    1) Switch on the device.

    2) Click on H8F.exe program

    3) Click on Option button, then click where shown in figure

    (if you set COM1 on 8) now set Com1)

    4) Then click OK

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    8.16.6 PROGRAM PHASE

    1) Click on File cell, then select *.obj extension as file type, and where the file to upload is located.

    2) Select file to upload, then click ok

    3) Click on Activate cell

    4) At the end of the program phase, a pop up message box must appear

    5) If no message box appears, reload the file then click activate.

    6) The message box report the programmed byte and the average retry time.

    7) This must be 1.0000, then click OK. If NOT click on Activate again.

    8) The device should beep and display the writing, FORMATTAZIONE MEMORIA SERIALE.

    9) Wait few minutes, then the device should restart.

    10) Switch off the device.

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    9 Flexa checking procedures

    TOOLS REQUIRED:

    Multimeter

    PROCEDURE:

    1) Check resistance between pin 1 and pin 2

    2) Check resistance between pin 4 and pin 5

    3) Compare measured values with following table

    min value [] max value [] pin 1-2 7 12

    pin 4-5 18 21

    Table 9-1 : Flexa resistance values

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    10 Cylinder checking procedures

    TOOLS REQUIRED:

    Multimeter

    PROCEDURE:

    1) Check resistance between pin N and pin L

    2) Compare measured values with following table

    min value [] max value [] Cylinder 80 82 85

    Cylinder 50 89 92

    Cylinder 30 162 165

    Table 10-1 : Cylinder resistance values

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    11 Trolley replacing procedures

    TOOLS REQUIRED:

    3, 4 and 5 mm Hexagon keys

    8 mm metric wrench

    slot screw drive.

    PROCEDURE:

    Referring on following exploded pictures replace the desired part

    ITEM DESCRIPTION CODE QUANTITY

    1 Plastic part M1050249 1 2 Plastic part M1050254 1 3 Screw 6 4 Plastic part M1050255 1 5 Washer 4 6 Nut 4

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    ITEM DESCRIPTION CODE QUANTITY 1 Plastic part M1050250 1 2 Screw 6

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    ITEM DESCRIPTION CODE QUANTITY 1 Spacer 4 2 Plastic part M1050251 1 3 Plastic part M1050252 1 4 Screw 6 5 Plastic part M1050256 1 6 Plastic part M1040256 1 7 Washer 4 8 Screw 4

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    ITEM DESCRIPTION CODE QUANTITY 1 Metal part M1040323 1 2 Metal part M1040324 1 3 Washer 14 4 Screw 14 5 Plastic part M1050260 2 6 Metal part M1040326 4 7 Plastic part M1050248 4 8 Washer 4 9 Nut 4 10 Wheel M1080014 2 11 Wheel with brake M1080013 2 12 Screw 4

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    ITEM DESCRIPTION CODE QUANTITY

    1 Metal Part M1040323 1 2 Metal Part M1040325 1 3 Washer 8 4 Screw 8 5 Screw 4

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    12 Recommended regular checks

    At least once a year check the power cable and replace if it shows signs of wear.

    It is advisable to have technicians authorized by ASA to check the electrical safety of the appliance

    (resistance of the protective conductor, leakage currents) once a year.

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    13 Spare parts

    Figure 13-1 : Exploded view

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    DESCRIPTION CODE POSITION

    Appliance base M1050264 1

    Appliance cover M1050265 2

    Back Sticker M2140290 18

    Clamp M1090130 23

    DB9 snap rivet M1090131 22

    Display frame M1050266 8

    Display frame snap rivet M1090132 16

    Display Interface D501097# 11

    Easy Fuse M3110025 X 3

    Easy Electronic board D500067# X 23

    Electronic board snap rivet M1090125 13

    Fan M2020001 5

    Fan rubber support M1090124 14

    Foot M2040008 7

    Front Sticker M2140292 19

    Fuse Drawer M2180003 3

    Lamp board D500053# 10

    Cylinder connector M2010200 X 6

    Plastic cap M1090133 9

    PMT Fuse M3110027 X 3

    PMT Electronic board D500066# X 20

    Power board M3160054 21

    Power filter M2030016 3

    Protective side shell M1050241 4

    Protective side shell spacer M1090119 17

    Side shell barbed rivet (long) M1090127 13

    Side shell barbed rivet (short) M1090126 12

    Note: X at the end of spare parts code is variable depending on SN of appliance.

    # is a variable letter depending on spare part code review

    Always communicate to ASA SN of appliance when ordering a spare parts, so the correct version

    of spare parts can be identified

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    14 Troubleshooting

    14.1 Device is not working

    Check main switch Check power cord connection on device and on wall socket Check fuses Check mains

    14.2 Display is not working

    Check flat cable between display board and Magneto Board.

    14.3 Motorized bed not recognized

    Check motorized bed main switch Check power cord connection on motorized bed and on wall socket Check motorized bed fuses Check motorized bed connector on device Check mains

    14.4 Flexa not working

    Check Flexa connection on device Execute Flexa checking procedures described at chapter 9

    14.5 Cylinder not working

    Check cylinder connection on device Execute Cylinder checking procedures described at chapter 10

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    15 Notes and personal remarks