VeriQ and VeriQC Service Manual Rev G

10.2. 10.3. 10.4. 10.5. 10.6. 11

ATX PSU ... 75 EXTERNAL ETHERNET BOARD ... 77 MEMORY MODULES (RAM) ... 79 CPU ... 81 MOTHERBOARD ... 84

SYSTEM UPGRADE ... 92

11.1. 12

DICOM INTERFACE UPGRADE ... 92

SOFTWARE ... 93

12.1. 12.2. 12.3. 12.4. 12.5. 12.6. 12.7. 12.8. 12.9. 12.10. 12.11. 12.12. 12.13. 12.14. 13

DETERMINE THE CURRENT SOFTWARE VERSION ... 93 UPDATE DEVICE SOFTWARE ... 93 GENERATE A SYSTEM REPORT... 94 EXPORT LOG FILES ... 94 START THE SYSTEM IN MAINTENANCE MODE ... 95 ACCESSING LOG FILES ... 96 EXPORT CLINICAL DATA ... 97 EXPORT SYSTEM SETTINGS ... 97 IMPORTING CLINICAL DATA AND SETTINGS ... 98 CALIBRATE THE TOUCH SCREEN ... 98 CHANGE REGION AND LANGUAGE SETTINGS ... 98 CHANGE COMPUTER NAME AND DOMAIN... 100 RESTORE SYSTEM HDD IMAGE(S) ... 101 UPDATE DEVICE DRIVERS ... 101

ELECTRICAL SAFETY TEST ... 102

13.1. 13.2. 13.3. 14

GROUND CONTINUITY TEST... 103 INSULATION TEST ... 104 LEAKAGE CURRENT TESTS ... 108

FINAL ACCEPTANCE TEST ... 113

14.1. 14.2. 14.3. 14.4. 14.5. 14.6.

TOOLS AND TEST EQUIPMENT REQUIRED: ... 113 TEST OF FLOW CHANNELS ... 113 TEST OF AUXILIARY CHANNELS ... 114 PRESSURE TEST ... 114 IMAGING UNIT FUNCTIONAL TEST ... 115 DOPPLER TEST ... 118

15

PERIODIC MAINTENANCE ... 119

16

SERVICE REPORTING ... 119

APPENDIX A.

PRINTER INSTALLATION AND CONFIGURATION ... 140

INTRODUCTION ... 140 1

INSTALLING A CANON PIXMA MG3500 SERIES PRINTER ... 140 1.1. 1.2. 1.3. 1.4.

2

INSTALLING A CANON PIXMA IP4900 SERIES PRINTER ... 142 2.1. 2.2.

3

DRIVER INSTALLATION ... 140 PRINTER WIFI CONFIGURATION ... 140 PRINTER DRIVER CONFIGURATION ... 140 CHANGING INK CARTRIDGE ... 141

DRIVER INSTALLATION ... 142 PRINTER DRIVER CONFIGURATION ... 142

INSTALLING A CANON PIXMA IP3600 SERIES PRINTER ... 143

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3.1. 3.2.

DRIVER INSTALLATION ... 143 PRINTER DRIVER CONFIGURATION ... 143

APPENDIX B.

VERIQ SPARE PARTS ... 144

APPENDIX C.

SERVICE REPORT FORM (PAGE 1/7) ... 145

APPENDIX D.

SERVICE REQUEST FORM ... 152

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ABBREVIATIONS Acronym

Explanation

2D ACI CM CPU DICOM EM ESA ESD GUI HW I/O OR OS PDB PM POST PPP PSU QL R&D RAM RMA SN SW TT&T TTFM

Greyscale Ultrasound Image Acoustic Coupling Index Corrective Maintenance Central Processing Unit Digital imaging and communication in medicine (communication protocol) Electronic Module Electrical safety Analyzer Electro Static Discharge Graphical User Interface Hardware Input/output data communication Operating Room Operating System Power Distribution Board Preventive Maintenance Power On Self Test Pay Per Procedure Power Supply Unit Qualification Level Research and Development Random Access Memory Return Material Authorization Serial Number Software Transit Time and Trace Transit Time Flow Measurement

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1

Introduction

1.1. INTENDED AUDIENCE The procedures described in this manual are intended for hospital technicians and other personnel, trained by Medistim, to do service and repair of the VeriQ system.

1.2. REQUIRED QUALIFICATIONS Performing service, repair and other interventions to medical devices requires documented qualifications to ensure continued safe operation of the device. In addition to training provided by the device manufacturer, many countries require formal education to legally perform service to medical devices. In this manual, two qualification levels have been defined based on the impact of the procedures. The different operations described have the required qualification level specified. Qualification level 1 (QL-1) is required to perform service and maintenance that do not interfere with the system’s safety functions. Qualification level 2 (QL-2) is required to perform all procedures described in this manual. NOTE: The User, e.g. operator, nurse or surgeon is only qualified to perform troubleshooting according to the User Manual’s trouble shooting guide.

1.2.1 Qualification level 1 (QL-1) QL-1 is required for service interventions posing no risk of altering the system’s basic safety and performance. Personnel with QL1 are not allowed to do changes or replacements of critical components. See chapter 4 VeriQ Access Diagram for complete overview. Typically, sales personnel, distributors and other personnel with technical experience of the VeriQ system obtain this level. The following requirements must be fulfilled before doing any QL-1 procedures as described in this manual: 1. Experience with medical devices. 2. Good understanding of the VeriQ system and its use (as described in the User Manual). 3. Attended service training provided by Medistim.

1.2.2 Qualification level 2 (QL-2) QL-2 is required for interventions which need special attention in order to keep the system safe. Personnel with QL2 are allowed to do replacements or alterations of the system regarding safety, EMC and ESD critical functions, typically: TT&T board, Power Supply etc. Refer to chapter 4 VeriQ Access Diagram for complete overview. Personnel with the need of QL-2 will typically be technicians at the department for medical technical equipment at the hospital and the service technicians of Medistim distributors that intend to offer service and support services in the local market. In addition to the qualifications required for QL-1, QL-2 personnel must also fulfil the following requirements: 1. Fulfil national regulations for performing service and repair of electro-medical devices. In many countries, this implies formal technical education and registration by the health authorities. 2. Relevant education and qualifications to do service and repairs, including electrical safety, safe ESD working procedures, troubleshooting and software.

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1.3. SERVICE CHAIN For any individual involved in servicing the VeriQ, it is important to fully understand his or her position, responsibilities and expectations from the service chain. The goal is to minimize the down-time following a system malfunction. The service chain identifies the different service lines, with their individual roles and responsibilities and what information is to be shared between them during the resolution of a problem.

1.3.1 Service lines The following service lines are defined: Service Line 1: The technical department at the hospital where VeriQ is operating. Service Line 2: The local distributor, service representative Service Line 3: Medistim Service department Service Line 4: Medistim R&D department

1.3.1.a Service line 1 Responsibilities 1. Immediately upon a service request from the system operator, begin troubleshooting according to this manuals chapter 3 Troubleshooting guide. If the required qualifications are not met for solving the problem, a service request must be issued to Service line 2. 2. Before starting solving a problem, make sure that the latest issue of this service manual is being used. 3. Perform repair and test according to this manual and in accordance with the required qualification levels. 4. Only use tools and equipment indicated in this manual. 5. Only use spare parts provided by Medistim. 6. For each resolved user service request, immediately fill out and provide a Service reporting to Service line 2 and file a copy in the system service log. 7. Upon request from the local distributor, respond with an up-to-date service log.

1.3.1.b Service line 2 Responsibilities 1. Immediately upon a Service Request from Service Level 1, verify if the root cause of the issue has been identified or not, if needed by contacting the issuer of the request. 2. Support Service Line 1 with troubleshooting and repair. 3. If the required qualifications are not met for solving the problem, or the solution is not found in this manual, a Service Request shall immediately be issued to Service line 3. 4. Keep in stock and provide essential spare parts to Service Line 1. 5. If not in local stock, put an order of necessary spare parts to Medistim Service Center. 6. Depending on situation and the Service level agreement with customer, either a visit to the hospital could be arranged, or the system is requested for return from customer. 7. Service Line 1 responsibilities 2 to 5 applies. 8. For each resolved Service request, immediately fill out and provide a Service reporting to Service line 3 and file a copy in the Distributor’s Service log. 9. Upon request from Medistim Service Center, provide the Distributor’s Service log.

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1.3.1.c Service line 3 Responsibilities 1. Immediately upon a Service Request from Service Level 2, verify if the root cause of the issue has been identified or not, if needed by contacting the issuer of the request. 2. Support Service Line 2 with troubleshooting and repair. 3. Keep in stock and provide spare parts needed for all QL1 and QL2 service interventions. 4. On a regular basis, request service logs from distributors and update DHR’s accordingly. 5. Update and distribute new versions of the Service manual and other supportive documents as needed. 6. If system is locally repaired or updated, create a service report to be appended with the system being returned.

1.4. SUPPORTIVE DOCUMENTS AND INFORMATION All documents and templates needed for proper service, documentation and interaction between Service lines, as required by the service chain will be provided on request by email to [email protected].

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1.5. USING THIS MANUAL Below follows an overview of the content and purpose of each chapter in this manual. •

Chapter 2 System Overview contains a rough description of the system and its components, with instructions for unpacking and performing the initial installation of the VeriQ device.

•

Chapter 3 Troubleshooting guide lists the failure modes most likely to be encountered. Service line 1 may use this to define a problem, then rectify minor issues or make a more detailed service request.

•

Chapter 4 VeriQ Access Diagram is a comprehensive description of how to gain access to the various system modules, and in turn, perform service on the individual components in each module. There are three access levels, and four defined groups of assemblies as shown.

•

Chapter 5 Disassembly/reassembly instructions gives detailed instructions on how to disassembly and reassembly the system according to the access diagram in chapter 4.

•

Chapter 6 - 10 Miscellaneous Service instructions: These chapters include all detailed trouble shooting, service and replacement instructions for the individual parts of the system. The instructions are grouped in chapters according to the access levels defined in the access diagram.

•

Chapter 11 System Upgrade describe what hardware modifications can be offered to enhance the functionality of the VeriQ

•

Chapter 12 Software explains how to perform software modifications; maintaining and upgrading the software, back-up and restore of patient data and system settings etc.

•

Chapter 13 Electrical safety test describes requirements for recurrent safety testing according to IEC 62353. Whenever applicable this chapter is referred to from the service instructions.

•

Chapter 14 Final Acceptance Test describes a test of the systems basic functionalities.

•

Chapter 15 Periodic maintenance describes how to perform basic periodic maintenance.

•

Chapter 16 Service reporting explains how to use the Service Report Form found in Appendix C. This must be filled out for every service action, including preventive and corrective maintenance.

•

Appendix A Printer installation and configuration is a complete list for Installation and configuration of the various printers approved for the VeriQ

•

Appendix B VeriQ Spare parts lists all available spare parts for the VeriQ system.

•

Appendix C Service Report Form (page 1/7) contains the relevant control points for the various procedures in this manual. It must be filled out as described in 16 Service reporting

•

Appendix D Service Request Form must be filled out every time technical support is required to complete corrective or preventive maintenance.

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2

System Overview

2.1. VERIQ (SOFTWARE VER. 3 SERIES) (PART NR: VQ4122 VQ2111 VQ1111 VQ4001 VQ2011 VQ1011 VQ1001) The VeriQ system is designed for intra-operative quality control and for documentation of surgical procedures. The system is able to measure transit time volume flow and Doppler blood velocity. All significant parameters and user controls are displayed on a 19” touch sensitive LCD.

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2.2. VERIQC The model VeriQ system VQ4122C labelled with brand name VeriQC is based upon the VeriQ system platform, but is fitted with an additional Imaging module to allow ultrasound images of the tissue structure. Blood velocities can be measured with PW Doppler (Pulsed Wave Doppler) or displayed as a color flow map on top of the 2D image.

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2.3. DETERMINING SYSTEM SERIAL NUMBER The serial number, model and revision are printed on the system identity label located on the upper front side of the electronic unit, just underneath the top cover.

VeriQ System identity label example

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2.4. FIRST INSTALLATION When receiving the VeriQQ, in addition to a visual inspection, a functional test should be performed according to chapter 14 Final Acceptance Test. This test should be performed to ensure nothing has been damaged in transit. Make sure the VeriQ shipping crate is good and whole. It is equipped with one “shockwatch” sticker and one “Tiltwatch” sticker, each on their opposite long-sides. If any of them have been triggered, do not reject the shipment, but note this in the feedback report along with any other observations. The feedback report can be found on top of the system monitor, underneath the packing material. Please fill out the report and e-mail it to [email protected].

2.5. UNPACKING INSTRUCTIONS The VeriQ is placed on its back when the crate is resting on its bottom pallet. Remove the crate lid by unhooking the clips around its edges. With the crate lid off, go to the monitor-side and lift the crate to an upright position so the VeriQ is resting on its wheels inside. The VeriQ can now be rolled out. Keep the crate and packing material for later, in case the system needs to be returned.

2.6. SYSTEM START-UP SEQUENCE The following will happen when the main power cable is connected to a working power outlet: 1. The power button in front of the transformer unit (under the printer shelf) will light up in standby mode (green light). With the main power cable connected, the following will happen when the soft-power button is pressed: 1. All the system fans will start spinning at a moderate speed. 2. The monitor will shortly display a “elo touch solutions” screen, before switching to a mostly black boot screen indicating: “MEDISTIM – Starting device”. 3. The VeriQ application will automatically start. The whole start-up sequence should take around one minute to complete. When it finishes, the home screen is displayed, with possibilities to select applications and managing patients. A continuous high-pitched sound (15kHz) will be generated from the TT&T-board when it has fully started.

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3

Troubleshooting guide

This guide will mainly help Service Line 1 with identifying a proper failure mode, easing later service. Most procedures linked to below will require QL1 or QL2.

3.1. “DETECTING HARDWARE” IS INDICATED WHEN THE SYSTEM IS STARTED UP. ... 14 3.2. “DEAD” SYSTEM (NO FAN SOUNDS) ... 15 3.3. NO PICTURE ON THE MONITOR, FANS ROTATING: ... 18 3.3.1 “Lost connection to Imaging Module..”... 19

3.1. “DETECTING HARDWARE” IS INDICATED WHEN THE SYSTEM IS STARTED UP. If hardware detection for some reason is delayed during system startup, the following progress dialog will be displayed until the hardware has been successfully detected.

If the progress dialog is displayed every time the system is started, this indicates a persistent problem with the system configuration as this dialog should normally not be displayed. In order to resolve any configuration issues the device needs to be restart into maintenance mode and then back to clinical mode as described in chapter 12.5. to allow the operating system to make the necessary configuration changes. If the required hardware is not detected even after several attempts during system startup, there is most likely a problem with the hardware. An error message will be displayed to the user, informing the user about which hardware the software has been unable to detect. The system report and log archive should then be exported as described in chapter 12.3 and 12.4 and provided to service line 2 or 3. You may also analyse the log files as described in chapter 12.6

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3.2. “DEAD” SYSTEM (NO FAN SOUNDS) If the system remains non-responsive after pushing the soft-power button, perform the below step-by step guide to determine the root cause: 1. Is there a green light in the power switch underneath the PC Unit?

Result: NO

YES

Action: - Make sure the power cable is firmly connected to both mains on the VeriQ and to the wall power outlet. - Make sure the switch is turned on. - Check and if necessary replace the fuses as described in chapter 7.2 - Proceed to next step.

2. Is there a green light on the printer’s power button?

Result: NO

YES

Action: - Measure the voltage output level from the Transformer Unit. Check all 3 outputs; “System Printer”, “Front End Unit” and “System Unit”.

- If necessary, replace the Transformer Unit needs as described in chapter 7.4 - Proceed to next step.

3. Is the power cord from the Transformer Unit output labelled “System unit” connected to the ATX PSU underneath the EL Module? Result: NO YES

Action: Attach the power cord firmly. Remove the front cover as described in chapter 5.1.3 Proceed to next step.

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4. Is the green LED (LED PWR Standby) on the motherboard emitting? Intel DG43NB

Intel DH67CL

LED PWR Standby

Result: NO

YES

Action: Make sure the 2x12 pin ATX power connector is firmly attached to the MB. If ok, Replace the ATX PSU as described in chapter 10.2.1 Next step

5. With a volt meter, measure the voltages on the Green wire (Power On) and one of the Black wire on the 2x12 pin ATX power connector while it is still connected: Does the +5V turns to 0V when you press the Power Switch? Result: Action: NO Make sure the 6pin blue molex connector (Front Panel Connector) is firmly attached to the motherboard. If the connector is fine, go to next step 6. YES Go to step 7

Intel DG43NB

Intel DH67CL

6. Does the Green wire turns from +5V to 0V when shortcutting pin 6 and 8 on the “front panel connector” on the motherboard directly with a conducting screw driver etc? Result: Action: NO Replace the Motherboard as described in chapter 10.6.3 YES, and system powers up YES, system still do not start

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Replace the Power Switch as described in chapter 9.4 Next step

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7. With a volt meter, measure the voltages on the Grey wire (Power OK) and one of the Black wire on the 2x12 pin ATX power connector while it is still connected: Does the 0V turns to +5V when you press the Power Switch? Result: NO YES

Action: Replace the ATX PSU as described in chapter 10.2.1 Next step

8. Disconnect all components* from the motherboard except from the ATX PSU, CPU and CPU Fan. Does the system power up when pressing Soft Power Switch? Result: Action: NO Replace the Motherboard as described in chapter 10.6.3 YES -Reinsert the removed components, one by one to determine which component is interrupting the POST. -Replace the part referred in VeriQ Access Diagram in chapter 4.

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3.3. NO PICTURE ON THE MONITOR, FANS ROTATING: 1.

Confirm that the VGA/DVI cable is firmly connected to the motherboard underneath EL Module and to the monitor.

2.

Check the systems USB ports, if there’s a USB flash drive connected, it might prevent bootup.

3.

Remove the HDD as described in chapter 7.3.2 Start up the system (without the HDD connected) Test Result: Action: Still no picture Go to step 4 “No Boot Device found” You have a faulty HDD or SATA connections. indicated on screen Open the Front Cover and connect the HDD directly to the Motherboard SATA connector. a. If this works you have a faulty HDD Bay SATA Connector b. If the problem persists, replaced the HDD

4.

Test the monitor by connecting the VeriQ monitor video cable to another computers DVI/VGA output. Make sure the system still on and gives power to the monitor while doing this. Test Result: VeriQ monitor works on another computer VeriQ monitor doesn’t works on another computer

Action: Go to step 6. Monitor needs to be replaced, confirm by testing the VeriQ with another monitor

5.

Open the front cover as described in chapter 5.1.3

6.

If any* of the Medistim PCI boards inside the PC Unit is not firmly attached to the system or maintain a shortcut/malfuction, the system might not boot up. It will start up (Fans rotating, red/orange light on monitor) but the system will stay in a “protection mode”

If this does not help you should remove all the measure boards and try to boot up the system. If it does boot up correctly without the PCI board connected you have a faulty PCI measure board. *Then you need to put the boards back one by one in order to find which one is preventing (*Systems without TT&T Board) 7.

Remove all of the memory modules and insert just one back into the Black DIMM-0 on top first and start the system. Then insert the second one back into the Black DIMM-3 below the first one and start the system.

8.

Remove the USB cable from the TT&T board and start the system.

9.

If there is still no picture on the monitor it is likely that the motherboard needs to be replaced.

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3.4. “LOST CONNECTION TO IMAGING MODULE..” Confirmation of possible cause 1. If the error message appears multiple times, even after restarting to maintenance mode two times, Inspect the R45 connector underneath the EL-Module. Is there any green/yellow light on the Ethernet connector on the motherboard?

Yes: Perform step 2-3. No: Perform step 4-9. 2. Exit to maintenance mode and start Internet Explorer. 3. Enter 10.0.0.3 in the address field. Do you see the following window?

Yes: If you can see the above window you do have logical connection with the scanner. Go to step 3. No: If you do not get any connection you will need to check the rest of the connection: Go to step 5. 3. Click on “UDP-Config” and provide us with the CU and PSU log file. (See: chapter 12.4) 4. Open: Device Manager and check the status on the Network adapters. Is there is a yellow “!” in the list? (this could indicate that there is something wrong with the network adapter) Yes: Right click on the adapter and check the status. Depending on the status you might need to reinstall the driver or replace the motherboard. (Contact Service line 3.) No: Go to step 5. 5. Carry out step 2, 6 and 11 in procedure 9.2.1 Imaging Unit replacement to get access to the Imaging Unit. 6. Test the network cable by connecting another standard network cable between the motherboard Ethernet connector and the Imaging unit. 7. Is there now any green/yellow light on the Ethernet connector on the motherboard? Yes: The network cable is defective and needs to be replaced. No: Go to step 7. 8. Connect the network cable from the motherboard to a another network connection (Ex: LAN network connection in your office) Does the yellow and green light on the network connection lights? Yes: The Scanner seems to have a hardware problem and needs to be replaced. No: Go to step 9 9. Make sure that both power-cables (yellow/black) on the backside of the Imaging Module are firmly attached similar as showed on picture below:

If the cables is fine it is likely that the Imaging unit must be replaced. Contact Service Line 3.

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If the error message appears multiple times, even after restarting to maintenance mode two times, 1. Exit to maintenance mode and start Internet Explorer. 2.. Enter 10.0.0.3 in the address field.

3. Click on “UDP-Config” and provide us with the CU and PSU log file. (See: chapter 12.4)

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4

VeriQ Access Diagram

The access diagram shows the logical sequence to gain access to various system components. Green boxes require QL1, blue boxes require QL2, as defined in 1.2 Required qualifications.

Complete System

Back Cover Removed

Remove Back Cover

Remove Top Cover HDD

Remove Front Cover

Top Cover Removed Imaging Module Probepanel

Software

Speakers

Fuses

SmartCard reader

Mains Cable

Power Switch

Transformer

Front Panel USB

Front Cover Removed

Ventilation bracket Removed

Monitor

Printer Wheel(s) Voltage Configuration

Remove Ventilation bracket Qualification level 1

Doppler Board

Qualification level 2

TT&T Board

Action for subsystem access

ATX PSU

External Ethernet Board Memory

CPU

Motherboard

Figure 1 VeriQ access diagram

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