OEC 9800 -9900 Planned Maintenance Supplement Rev 1

Revision history

Revision history Document # 5755800-199-01

Revision #

Release Date

1

10-2016

Document / Version Notice: GE Healthcare provides this documentation “as is“, without the assumption of any liability under any theory of law. GE Healthcare reserves the right to change its products and services at any time. This manual is subject to change without notice. This printed document is the version at the time of system delivery and / or print run. Revisions are not automatically distributed. Contact GE Heathcare at 800-874-7378 to order an updated version. This manual may not be reproduced, in whole or in part, without the written permission of GE OEC Medical Systems, Inc. OEC is a registered trademark of GE OEC Medical Systems, Inc. Other product and company names mentioned herein are the property of their respective owners. The contents of this document are accurate at the time of publication. However, changes in design and additional features can, at any time, be incorporated in the hardware and software and may not be reflected in this version of the document. Contact GE OEC Technical Support for clarification, if discrepancies arise. GE OEC Medical Systems, Inc. a General Electric Company, going to market as GE Healthcare.

GE OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, Utah 84116 U.S.A. 801-328-9300

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GE OEC 9800-9900 Planned Maintenance Supplement

1. Planned Maintenance Supplement (EN) Disclaimer Service described in this document is to be performed by qualified GE Healthcare personnel or GE Healthcare's authorized affiliates. Assemblers and other persons who are not employed by or otherwise directly affiliated with or authorized by GE Healthcare or one of its affiliates should contact GE Healthcare or one of its affiliates before attempting installation or service procedures. Document / Version Notice: GE Healthcare provides this documentation “as is“, without the assumption of any liability under any theory of law. GE Healthcare reserves the right to change its products and services at any time. This manual is subject to change without notice. This printed document is the version at the time of system delivery and / or print run. Revisions are not automatically distributed. Contact GE Heathcare at 800-874-7378 to order an updated version.

Owner responsibilities Based on the concept of risk management, routine checks and planned maintenance are required for the mobile C-Arm system to ensure safe operation, reliable system performance, and correct diagnostic results. Follow the detailed work instructions and safety information for all service and maintenance activities included in this document. Contact your local GE Healthcare service representative for detailed information. Proof of these maintenance activities is required in certain countries. Refer to your system's operator manual for details on the functions described in this supplement.

Definitions Planned maintenance must be performed by qualified and authorized service engineers. In this context: l

l

Qualified means that the service engineer has been trained and has had practical experience in the required routines so that he/she is capable of performing service work on the system. Authorized means that the service engineer is recognized by the system owner as a qualified service engineer and is therefore authorized to perform maintenance work on the system.

Upon system start-up, GE Healthcare recommends designating one employee who is responsible for ensuring that routine checks, preventive inspection, and maintenance work are performed and that evidence is retained. In addition to repair services, GE Healthcare also offers its customers complete planned maintenance service, including inspection and planned maintenance on GE Healthcare systems. These services can be provided either on a service call basis or in the form of a flexible maintenance contract.

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GE OEC 9800-9900 Planned Maintenance Supplement If you have not received a quotation for the performance of planned maintenance and inspection from our GE Healthcare Services team, your local GE Healthcare sales representative will provide this information for you. Your GE Healthcare representative can provide a quotation for planned maintenance and inspection.

Routine Checks (daily) Routine performance checks ensure that the system is operating correctly. The checks listed are not intended to substitute for scheduled planned maintenance. If problems are found during these checks, contact a qualified service engineer to troubleshoot and repair the system. NOTE: In addition to performance checks, safe cleaning practices are included and a description of planned maintenance that should be performed. Prior to performing any of the performance checks in this section, it is important that potential hazards associated with these tasks are understood. Review the safety and introductory information in the system operator manual before proceeding. Component / Function

Reason

Actions

Workstation Wheels

Ensure system mobility.

Check for ease of movement without excessive play.

Workstation Brake Pedal

Ensure system mobility and placement.

Check for ease of movement and proper control of the wheels without excessive play.

Workstation Monitor Latch

Ensure monitor positioning.

Make sure monitors are securely latched and latching mechanism is not loose and does not have excessive wear.

Workstation Monitor Arm

Ensure monitor positioning.

Check ease of movement without excessive play and that monitors maintain position.

Workstation Power Cable

Prevent loss of system Inspect for signs of wear, abrasions, loose prongs functionality due to power on plug. issues.

Interconnect Cable

Prevent loss of system Inspect for signs of wear, abrasions, loose pins, functionality due to missing pins, and worn strain relief. communication failures or power loss between Workstation and C-Arm.

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GE OEC 9800-9900 Planned Maintenance Supplement Component / Function

Reason

Actions

Workstation Touchscreen

Prevent loss of Inspect for contamination and clean as required. functionality or loss of calibration of touchscreen.

Workstation Function

Ensure that the Workstation is functional before beginning procedures.

Turn Workstation on and verify that the system successfully completes the start-up sequence.

Fans (X-ray tube, Workstation)

Prevent overheating of components that could result in a loss or degradation of system functionality.

While system is on, verify that fans are functioning and that all vents are clear of obstruction.

C-Arm Brakes

Ensure that the full range of motion is available and that C-Arm can be properly positioned.

Check Wig-Wag, Horizontal Cross-arm, Flip-Flop, and C-Arm Rotation brakes for ease of movements without excessive play and ability of the brake to hold the C-Arm in position.

L-Arm Brakes (LArm configuration only)

Ensure that the full range of motion is available and that C-Arm can be properly positioned.

Check L-arm rotation brake on standard 9" or 12" systems for brake operation and no excessive mechanical drift.

Radial Rotation Brakes (Super C configuration)

Ensure that the full range of motion is available and that C-Arm can be properly positioned.

Check radial rotation brake for ease of movement and no excessive mechanical drift on Super C systems.

C-Arm Rear Wheel Brake Pedal

Ensure system mobility and placement.

Check operation of the rear wheel pedal brakes.

C-Arm Steering

Ensure system mobility and placement.

Check for proper operation of steering handle and control of rear wheels, and that there is no excessive drift.

C-Arm High Voltage (HV) Cable

Prevent loss of system functionality (ability to take shots) or system errors (such as mA error).

Inspect HV cables for signs of wear and abrasion.

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GE OEC 9800-9900 Planned Maintenance Supplement Component / Function

Reason

Actions

Footswitch / Handswitch

Prevent loss of functionality for footswitch or handswitch. Prevent possible lock up due to stuck switch error.

Inspect footswitch and handswitch for signs of wear and abrasion on the switch and cable.

C-Arm Function

Ensure that the C-Arm is functional before beginning procedures.

Turn the system on and verify successful startup sequence.

C-Arm Vertical Lift

Ensure that the full range of motion is available and that C-Arm can be properly positioned

Raise the vertical column.

C-Arm Fast Stop

Ensure that the emergency stop function is available and functioning properly .

Press and hold one of the vertical column control switched and while motion is occurring press either fast stop button to verify mechanical motion stops and the message FAST STOP ACTIVATED displays on the C-Arm control panel display.

Fluoro Performance

Confirm capability of the system to take a shot when commanded.

Take an X-ray using the X-ray on switch located on the top of the control panel housing. Take a shot using the footswitch. Finally, take a show using the handswitch.

Collimator Functions

Ensure that the collimator is functioning properly in order to manage image size and orientation.

While pressing an X-ray on switch, verify operation of the image orientation keys (rotation and reversal), file size selection, and operation of motorized collimation controls (leave rotation iris collimation). On vascular systems, verify operation of the MODE switch.

Planned maintenance Planned maintenance activities are subdivided into the following activities: Activity

Interval

Safety checks (see page 5)

Every 12 months

Planned maintenance (see page 6)

Every 12 months

Recommended preventive replacement frequency (see page 6) Every 12-36 months

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GE OEC 9800-9900 Planned Maintenance Supplement Activity

Interval

Replacement due to wear and tear (see page 9)

As described below

Planned maintenance should be performed every 12 months. System service and maintenance should not be conducted when the system is in use with a patient.

Safety checks The following safety checks help maintain the system in a safe operating condition. Depending on the results, planned maintenance or repair may be required. The checkpoints are specified in legal regulations and / or safety standards. Component / Function

Reason for Safety Check

Actions

Interval

Antistatic Drag Wires

Ensure electrical grounding.

Inspect for wear and ensure contact with ground.

12 Months

Steering and Brakes

Ensure proper control when positioning system.

Perform steering and brake checks.

12 Months

AC Power Cord & Plug

Identify worn cable to prevent potential power loss or shock hazard.

Inspect AC power cable.

12 Months

Interconnect Cable

Ensure sound connections to prevent potential system errors due to communication issue.

Inspect interconnect cable 12 Months and receptacle.

Ground Continuity

Ensure adequate electrical grounding.

Measure ground continuity.

12 Months

C-Arm Battery Pack

Identify possible corrosion.

Visually inspect around the batteries within the compartment for corrosion.

12 Months

Transformer Output

Ensure that system power is sufficient to prevent errors and potential failures.

Perform transformer output check.

12 Months

High Voltage Cable

Identify worn cable to prevent potential power loss or shock hazard.

Inspect high voltage cable. 12 Months

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GE OEC 9800-9900 Planned Maintenance Supplement

Planned maintenance Planned maintenance helps to reduces unanticipated errors and to ensure minimum system requirements are met over the life of the system. These checks test the effects of various operating conditions (high or partial load, temperature, dust particle size, humidity, gases, vapors). If necessary, preventive maintenance or repair measures are performed as a result. The status of parts subject to wear is determined by recording and analyzing performance parameters. Component / Function

Reason for Planned Maintenance

Actions

Interval

Monitor Arm

Ensure that the monitor arm moves properly and retains position.

Perform monitor arm check and adjustment

12 Months

Fans / Filters

Prevent system overheating leading to degradation of system components leading to possible loss of full system functionality.

Check and clean. Replace if necessary.

12 Months

Power Supply

Ensure that the system power is sufficient to prevent errors and potential failures.

Inspect and adjust C-Arm power supply, setting at nominal recommended voltage output. Replace if necessary.

12 Months

Workstation

Ensure that the system is functioning fully as intended.

Perform Workstation panel diagnostics and functional test.

12 Months

IR Transmitter

Ensure that the IR transmitter is functioning as intended.

Perform IR transmitter functional test.

12 Months

Accessories

Ensure that the accessories function as intended.

Perform accessory functional test.

12 Months

Visual examination of C-Arm orbital and cross-arm brake pads

Identify deterioration of pads and prevent potential contamination of sterile field.

Visual examination and functional check. Replace if necessary.

12 Months

Footswitch

Ensure sound connections and examine for wear to prevent potential failure of the switch to function.

Visual examination and functional check. Replace if necessary.

12 Months

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GE OEC 9800-9900 Planned Maintenance Supplement Component / Function

Reason for Planned Maintenance

Actions

Interval

Handswitch

Ensure sound connections and examine for wear to prevent potential failure of the switch to function.

Visual examination and functional check. Replace if necessary.

12 Months

C-Arm High Voltage Cable Greasing

Prevent high voltage arcing leading to potential system malfunction and damage to components that could lead to loss of functionality.

Regrease and perform generator and X-ray tube calibration.

12 Months

Calibrate. Replace if necessary.

12 Months

C-Arm Generator and Optimize system performance X-Ray Tube calibration following HV cable greasing.

Recommended preventive replacement frequency GE Healthcare recommends replacing the following components as specified to prevent failure. These components are subject to wear and tear as they are used. Replacement will reduce the likelihood of unexpected failure. Recommendations are based on typical customer use. High use systems and / or systems used for high dosage situations may require replacement of these components more frequently. Preventive replacement is not covered by the standard planned maintenance contract coverage.

9800 Component / Function

Reason

Actions

Interval

Workstation CPU fan and heat sink

Prevent system failure due to overheated CPU.

Replace fan and clean heatsink.

36 Months

Workstation SBC coin cell batteries

Prevent loss of system functionality.

Replace.

36 Months

C-Arm GIB coin cell battery

Prevent loss of calibration data potentially impacting image quality or dose information or system functionality.

Replace.

36 Months

C-Arm MCU coin cell battery

Prevent loss of motorized motion functionality and system functionality.

Replace.

12 Months

C –Arm X-ray controller board coin cell battery (legacy)

Prevent loss of system functionality.

Replace.

12 Months

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GE OEC 9800-9900 Planned Maintenance Supplement

9900 Component / Function

Reason

Actions

Interval

Workstation Cine Drive

Prevent loss of data or data corruption Replace or loss of cine functionality

36 Months (not for ESP/GSP)

Workstation System Hard Drive

Prevent loss of data, data corruption (mixed data), loss of system functionality due to hard drive failure or bad sectors on drive.

Replace

36 Months

Workstation RTOS and Prevent system failure due to GPOS fan and heatsink overheated CPU.

Replace fan and clean heatsink

36 Months

Workstation RTOS / GPOS coin cell batteries

Prevent loss of system functionality.

Replace

36 Months

C-Arm GIB coin cell battery

Prevent loss of calibration data potentially impacting image quality or dose information or system functionality.

Replace

36 Months

C-Arm MCU coin cell battery

Prevent loss of motorized motion functionality and system functionality.

Replace

12 Months

Workstation WISP battery

Prevent loss of image archiving / transfer capability.

Replace

36 Months

Workstation UPS battery

Prevent data corruption or loss of system functionality due to uncontrolled shutdown.

Replace

36 Months

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GE OEC 9800-9900 Planned Maintenance Supplement

Replacement due to wear and tear The following components are subject to degradation and must be replaced during the life of the system. The rate at which the wear occurs depends on how the system is used and the conditions of that use. For example, customers who take a higher number of shots per day / procedure or who take higher level shots (for example, high level flouro) may experience a shorter life for the components. Operation of the system at elevated temperatures or other extreme environments could also affect the life of the components. Component / Function

Potential Effect

X-Ray Tube

Loss of X-ray capability. (Also part of planned maintenance.)

System Battery Pack

Loss of capability to perform high level fluoro shots. Loss of system functionality.

Footswitch

Uncommanded X-ray due to stuck foot switch. Loss of foot switch as an option for commanding X-ray. (Also part of planned maintenance.)

Handswitch

Uncommanded X-ray due to stuck hand switch. Loss of hand switch as an option for commanding X-ray.(Also part of planned maintenance.)

Brake Pads

Degradation of pads resulting in potential contamination of sterile field or reduction in ability of system to maintain desired position / orientation. (Also part of planned maintenance.)

Interconnect Cable Loss of system functionality due to communication loss between Workstation and mainframe. (Also part of planned maintenance.) High Voltage Cable Loss of X-ray capability. (Also part of planned maintenance.) Power Cable / Cord Loss of system functionality due power loss or interruption of power. (Also part of planned maintenance.)

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