Customer Information

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Customer Information

Customer/Hospital:

City: Service Order No (SVO):*

Dept: Sales Order No:*

S/N: Purchase Order No (PO):*

* If applicable

Purpose

This Maintenance and Inspection Checklist:

 lists the maintenance, inspection and safety checks of ExacTrac systems and its components,

 ensures the safety and functionality of ExacTrac,

 should be performed on a regular base.

Preparation and Necessary Tools

Check salesforce.com history of the functional location where you intend to perform a PMI to investigate if

 Robotics Batteries

 HV Silicone oil and disks

 Floor box sealing and angle frames

 RTM lubrication

 Protective Earth

 Workstation air filters need to be replaced/checked or not.

Check the functional location, if the customer has the USB backup device in place or not (applicable for Service Contract customers). If not and this is a Service Contract customer, order one to be left on site after the PMI.

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General tools:

 5-50 Nm torque wrench

 20 Nm – 120 Nm Torque Wrench (for the ceiling arm mounts, only 100 Nm is needed)

 Allen key sets – metric and inch and Screw driver sets

 Hexagonal socket wrench 8 mm or 5/16” and 3/16” with drive square 3/8”

 Extension for Hexagonal Socket Wrench

 Calibrated multimeter (TME)

 Cable binders

ExacTrac equipment:

 Phantom with implanted sphere necessary for final positioning/monitoring test

For workstation maintenance:

 SUSeek on a memory stick

 Air Filter for workstation (otherwise the used ones can be washed)

 External USB harddrive for backup images

For Spectra camera firmware upgrade:

 46810 NDI SPECTRA FIRMWARE UPGRADE KIT (order will trigger label shipment)

 NDI Toolbox on a memory stick

For STI / Electrical Safety Test:

 Calibrated Multimeter (TME)

 Calibrated Electrical Safety Analyzer (Secutest, Fluke ESA)

 W20341/W20341A Patient Resistance Phantom for Multimeter (TME)

 Long PE cable to connect Electrical Safety Analyzer to PE bar

 46130-17 ET VMS ILK Simulator

 Any camcorder device for cabinet LED observation, e.g. laptop with webcam

 FTDITool on a memory stick For Robotics maintenance:

 49765 RTM Battery Kit (4 batteries), if required (check on salesforce.com)

 Calibrated digital water level

 Lubricant (recommended brand name: Molycote)

 For Robotics 1:

o W20306 Robotics FW Upgrade Kit, if Robotics firmware has to be upgraded/updated

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For X-ray system maintenance:

 For Floor Box 17”:

o Silicone Paste

 For 12“ Floor Box:

o ~6m of W 20326 ET Sealing Tape 50m _2mm Floor Boxes/Tube (can be ordered in 50m units, see Service Tools list)

o For version 49373 not yet equipped with the zinc coated 49373-03A angle frame:

2x 49373-03A: ET floor box 12’’ angle frame

 For On-Floor Box:

o ~8m of W 20326 ET Sealing Tape 50m _2mm Floor Boxes/Tube (can be ordered in 50m units, see Service Tools list)

o ~5m of W 20327 ET Sealing Tape 50m _4mm On Floor Box

 For HV cables:

o 49800-21 ET High Voltage Silicone Kit (1x), if required (check on salesforce.com)

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Calibrated Tools / TME

^N/A

This section is applicable for all TME tools used to complete this checklist.

The Calibrated Tools / TME (Test and Measurement Equipment) used during the

maintenance tests are documented in the list below. OK

TME Description TME number Expiration Date

________________________________________ ______________ ______________

1. Initial Function Check

This section is to verify that the system is properly working on arrival. It is no accuracy test and intended as reinsurance that Support personnel is not responsible for a defect.

NOTE: In case of Polaris camera, the system has to be warmed up for at least 60 minutes before starting this test.

Customer Information

Due to the integration of ExacTrac into the Linac environment it is recommended to instruct the customer to prepare a phantom patient on the Linac so that positioning workflows can be executed during the time of the PMI.

OK

ExacTrac function

Perform the “Positioning Workflow Test” described in SM 09-087 (as mentioned in the SM, skip and select the correct workflow steps as applicable for the tested hardware platform).

NOTE: The “Detect Winston Lutz Pointer” test mentioned in the last step of the “Positioning Workflow Test” does not have to be

performed at this stage.

OK

2. Phantom and Hardware Inspection

This section is to inspect all Calibration Phantoms, tracking tools and Hardware tools.

Tests are applicable as devices are available, otherwise check N/A.

When inspecting Phantoms and IR Arrays, please check each device:

 fixation pins are not bent, markers are not deformed, no damage is visible

 reflective surfaces are not worn off

 In case any discrepancy or defective part is found, the corresponding parts should be exchanged/

repaired either via time and material service or via a corresponding service contract/warranty.

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Isocenter Phantom

Repeat the test above for the Isocenter Phantom.

OK Repair or exchange recommended

Frameless RS

Positioning Array

Repeat the test above for the Frameless RS Positioning Array.

If markers are worn off, Body Markers can be used as replacement.

OK N/A Repair or exchange recommended

ET

Positioning Array

Repeat the test above for the ET Positioning Array.

OK N/A Repair or exchange recommended

X-Ray Positioning Star

Repeat the test above for the X-Ray Positioning Star.

OK N/A Exchange recommended

X-Ray Calibration Phantom

Repeat the test above for the X-Ray Calibration Phantom.

Positioning Arm Standard/

TrueBeam

Applicable for Positioning Arms Standard/TrueBeam Fixate the arm on a worn part of the side rail. Shake the arm moderatly.

The clamp is tight and there is no motion between clamp and side rail.

If there is motion and/or the clamp is loose, readjust the clamp and inform customer that an exchange of the siderail or clamp (e.g.

with ET Positioning Arm Standard Spare Front) is recommended.

ExacTrac Hardware

In Exactrac Safety Technical Inspection

Checklist, the ET STI – Visual Inspection is performed. OK

Robotics Applicable for Robotics 1 or Robotics 2:

In Patient Support Safety Technical Inspection Checklist, Visual Inspection section is performed.

OK N/A

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3. In-Room Components Inspection

Touch

Monitor Check the accuracy of the touch screen. Recalibrate if necessary. OK

Ceiling Mounted Monitor Arm

Applicable if the Ceiling Mounted Monitor Arm is installed:

Balance the spring force as specified in the service documentation SM 09-087/SM 10-298.

OK N/A

The handle bar of the monitor can be raised to at least 2.0 m from the floor.

OK N/A

Ensure that ceiling mount and monitor arm’s mechanical fixation have no play. If there is play, tighten all screws with the applicable torque according to the service documentation SM 09-087/SM 10-298.

OK N/A Screws re-tightened

Flat Panels

Applicable if the X-Ray system is installed:

Ensure that ceiling/device mounts and flat panels’ mechanical fixation have no play. If there is play, tighten all screws with the applicable torque according to the service documentation SM 09-087/SM 10- 298.

OK N/A Screws

re-tightened

In-Room Distribution Box

Not applicable if the In-Room Distribution Box is hidden behind a false ceiling or in any other way not accessible:

Visually inspect the Distribution Box and its cover. There are no exposed wires and the cover fits well onto the box. In case a broken part is found, the corresponding parts should be exchanged either via time and material service or via a corresponding service

contract/warranty.

OK N/A Exchange

necessary

Elekta Steel Beam mounted Ceiling mounts

Applicable for Elekta installation with Steel Beam Clamp mounted devices and W20340 (end buffer) already installed:

Ensure that W20340 UNI END buffer has no play. If there is play, tighten all screws with the applicable torque according to the service documentation SM 09-087/SM 10-298.

OK N/A Screws

re-tightened

IR Camera System

Ensure that ceiling/device mount and camera’s mechanical fixation have no play. If there is play, tighten all screws with the applicable torque according to the service documentation SM 09-087/SM 10- 298.

OK Screws

re-tightened

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IR Camera System

Lenses and IR illuminator are clean.

If required, the lenses and IR illuminator have been cleaned according to the procedure in the Clinical User Guide under section

“Storage, Cleaning and Disinfection Guidelines “

OK Cleaning recommended/

done

4. Computer Cabinet Inspection

This section is to check all switches in the ET Computer Cabinet.

Cabinet lamp and LEDs

Green indicators “Building Power” and “System On” are illuminated.

The push button “Computer On/Off” is illuminated yellow.

In case a broken part is found, the corresponding parts should be exchanged/ repaired either via time and material service or via a corresponding service contract/warranty.

OK Repair or exchange necessary.

Power-On timer

Applicable for 4.x/5.x HW platforms (for Polaris camera, not for Spectra):

The Power-on Timer is set to local time and to turn on at least one hour before treatments are started, every working day, according to the hospital needs.

OK N/A

Emergency button

Applicable for 4.x/5.x HW platforms:

Keep the workstation off and switch off the Flat Panel Power

Supplies. Press the “Emergency OFF” button. System is immediately shut down.

OK N/A

Workstation

Applicable for rack workstations (and not tower workstations):

Replace or clean air filters (can be washed with water) if needed. OK N/A Clean the external surface of the workstation.

And then, slide the Computer upper cover and check for dust accumulation.

If applicable:

Turn off the computer (unplug the cables and remove from the rack).

Find a suitable workspace to clean the dust in the computer, e.g. with compressed air (be carefull with any spills).

Note: Do not use a vacuum cleaner for the inside of the computer as it generates static electricity that can damage the components.

OK N/A

All cable connections to workstation are tight and correctly connected. OK

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5. X-Ray Components Inspection

^N/A

This section is to maintain and test all X-Ray components.

This section is only applicable if the X-Ray system is installed.

Spellman Serial Number Single Generator: __________________________

Or

Spellman Serial Numbers of both Dual Generators: ______________ / ______________

Note: You can find the Serial Number in the Generator label.

Floor Box sealing

Check the salesforce.com history (i.e. PMI cases) for this Functional Location.

The inspection of the floor box sealing is only necessary every 2 years. If

 no information is available, or

 the inspection occurred more than 2 years ago proceed as follow:

Turn off generator and start Windows Task manager, go to tab

“Services” and stop the Service Manager of the ExacTrac Services.

Hereby also the X-ray Service is stopped. Turn securely off circuit breaker of the X-Ray generator.

Open floor box cover and visually inspect the silicon and/or rubber sealing.

In case it is missing or damaged/worn, include in the Field Service Report a recommendation to renew the sealing and/or proceed with repair.

Leave a case comment about your work on the floor box sealing for upcoming PMIs.

OK/Not needed Exchange recommended

Repaired

Floor Box angle frame

Applicable if powder coated floor box angle frames are installed (49373-03):

Replace powder coated floor box angle frames (49373-03) by zinc coated floor box angle frames (49373-03A).

NOTE: Add comment to planned case of PMI in salesforce.com about performed angle frame replacement.

OK N/A

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HV silicon oil

Check the salesforce.com history for this Functional Location.

The replacement of the HV silicon oil is not necessary if it has been re-placed during the last 2 years. If:

 no information is available or

 the re-placement occurred more than 2 years ago or

 regional strategy is to perform this re-placement yearly, proceed as follow:

Turn off generator by exiting the ExacTrac software, turn securely off circuit breaker.

Exchange HV silicon oil and disks (49800-21) for both sides, at transformer and tube connection (at all 8 candle sticks) as explained in the SM 09-087.

NOTE: For the cables with oil: Once the connector has been opened the silicone disk has to be replaced by a new one. The old one can’t be re-used because of deformation.

NOTE: Add comment to planned case of PMI in salesforce.com about the renewed oil.

Paste/oil, disk ex- changed

Not necessary

Dual Generator CL

Applicable for Dual Generator CL unit with 50Hz power supply:

Verify the functionality of the oil pressure switch following the instructions in the SM 09-087 on Chapter of “Maintenance of X-ray components” (Oil Pressure Switch).

Please document testing result in PMI Sales Force case and send it to Customer Care in order to inform R&D about the result.

Note: Do not leave the oil pump running after testing, this will cause tube or pump damage within few hours as the water cooling is not connected.

Note: This check only needs to be performed once. Please check Sales force prior to this test.

OK N/A

X-Ray Console functionality

Applicable if HFe Single Generator is used:

Turn off generator.

HFe: Replace hand trigger by service dongle.

Turn on generator.

Perform Key Test by pressing all keys.

Use ▲cm and ▼cm to test LEDs, display and buzzer.

Console is fully functioning.

OK N/A

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X-Ray Elements on ET Console functionality

Applicable if Dual Generator (including Dual Generator CL) with dedicated ET Console and Software control is used:

Attention - Check that nobody stays in the treatment room during this test. X-ray occurs!

Start the ExacTrac application. Enter the Test acquisition Tab.

Select both tubes in dual operation.

Apply low energy values to both tubes:

--> The ring around the X-Ray trigger button lights up green.

Press the Trigger button until both exposures are finished:

--> The tone buzzer beeps two times and the yellow radiation lamp on the ET Console flashes accordingly. Both x-ray images appear on the screen.

OK N/A

Tube calibration (Single Generator)

Applicable for HFe Single Generators:

Turn generator on, setup/service mode.

Repeat the filament calibration steps of the tubes (as indicated in Installation Manual SM 10-165 and K&S service manual) to ensure that calibration values remain valid. If necessary, readjust the filament calibration values.

N/A OK

Recalibrated

Tube calibration (Dual Generator)

Applicable for Dual Generator (including Dual Generator CL) unit:

Perform a filament calibration for each generator according to the description in the Spellman service manual. If necessary, readjust the filament calibration values.

N/A OK

Recalibrated

Backup

With running service software, connected to each generator (depending on the installation):

Save a backup (SVC-file) of the latest generator and control desk settings as explained in the Spellman/KS documentation.

OK

X-ray correction images

Applicable if new X-ray tube calibration was performed:

Acquire new correction images using Exactrac OK N/A

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6. Control Room Component Maintenance

This section is to update the ExacTrac workstation and maintain Control Room components.

Cleaning If necessary, clean the user panels in the control room according to

the current CUG version. OK

Backup

Backup the ExacTrac ini-file to

“exactrac6x_ yyyymmdd_pre_PMI.ini”.

NOTE: “x” can be 0, 1, 2 or 5, depending on the version installed.

OK

Backup

Please indicate the paths configured in the ini file of ExacTrac Workstation:

PatPosPath : _________________________________________

BackupPath: _________________________________________

ArchivePath: _________________________________________

OK

Windows Update

Applicable if the operating system is Windows 7 and the customer does not ensure that the latest security patches are installed:

Install the latest security updates as described in the service manual.

OK N/A

System Time to R&V

Applicable if CBCT Import or R&V Export is available:

Ensure that the system time of R&V and ExacTrac is the same. OK N/A

Spectra latency timer parameter

Applicable for Polaris Spectra camera:

Set the latency timer of the NDI USB driver to 16 ms if not already done (see instructions in service documentation SM 09-087/SM 10- 298 on how to check this parameter).

N/A

Adjustment was already done

Adjustment done

Firmware Upgrade

Applicable for Polaris Spectra camera:

Check the firmware label on the back of the camera housing to make sure the firmware is up to date. See the ‘Check of Installed IR

Camera Firmware’ chapter in SM 09-087 if the sticker is not present.”

If required, upgrade the firmware version according to SM 09-87 chapter ‘IR Camera (Spectra) Firmware Upgrade (46810)’.

N/A

Upgrade not necessary Upgrade performed

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Applicable if Firmware Upgrade has been performed:

Enter an SPO for article 46810 for the applicable Functional Location. Label has been attached to the camera. NDI toolbox has been uninstalled after upgrade.

OK N/A

Firmware version (Robotics 1)

Applicable for Robotics 1:

Update firmware version as explained in the SM 10-120, if newer version is available as Field Upgrade article. Enter an SPO to book the Field Upgrade (49759A). Perform the Patient Support System Installation Checklist.

OK N/A Firmware updated

Disk free space

Check the disk space.

If it is low and if the patient data are stored locally, recommend to customer to check if old patient data can be backed-up and deleted from the disk to free some space.

If the amount of patient data is not the cause of the reduced space on the disk, identify the correct cause and inform the customer.

OK Clean-up recommended

7. ET Prep and Review Workstation Maintenance

N/A This section is to inspect the ET Prep and Review Workstation.

Indicate the Serial Number(s) of the inspected workstation(s) here:

__________________________________________________________

All cable connections to workstation are tight and correctly connected. OK If necessary, clean the external surface and interior of the workstation. OK

Applicable if the operating system is Windows 7 and the customer does not ensure that the latest security patches are installed:

Install the latest security updates as described in the service manual.

OK N/A

Check the disk space.

If it is low and if the patient data are stored locally, recommend to customer to check if old patient data can be backed-up and deleted from the disk to free some space.

If the amount of patient data is not the cause of the reduced space on the disk, identify the correct cause and inform the customer.

OK Clean-up recommended

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8. Robotics Inspection

^N/A

This section is to inspect the Robotics Tilt Module. Refer to the SM 09-083 for instructions about the PMI.

Lubricant

Lubrication is only necessary:

 every 2 years (combine it with the battery step below), or

 if during the motion of Robotics a “squeaking” noise is present.

Action: Add one drop of oil (lubricant - recommended brand name:

Molycote) to each cylinder, SM 09-083.

OK Not necessary

Battery exchange

The replacement of the batteries is not necessary if the batteries were exchanged during the last 2 years. If

 no information is available or

 the exchange occurred more than 2 years ago or

 regional strategy is to perform this exchange yearly, exchange the whole battery pack as explained in the SM 09-083.

NOTE: Add comment to planned case of PMI in salesforce.com about the performed battery replacement.

Batteries exchanged

Not

necessary

Safety Lock Test

The Service Lock Test according to Service Manual 09-83 Robotics 2 Service Manual (chapter 5.1) is successfully performed.

Purpose: Lock position is safely detected by the electronics.

NOTE: For Robotics 1, the ‘Service Locks’ are referred to as ‘Heavy Load Safety Locks’.

OK

Readjusted

STI

(Robotics 1)

A Safety Technical Inspection (STI) according to Brainlab instruction (Hardware User Guide) was performed.

The results of measurements were documented in the STI-Checklist (Patient Support System Safety Technical Inspection Checklist, FORM 09-1019) and handed out to customer. A copy is added to this list.

OK N/A

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STI

(Robotics 2)

A Safety Technical Inspection (STI) according to Brainlab instruction leaflet BL-IL-60911-99 STI Robotics (49702) was performed.

The results of measurements were documented in the STI-Checklist (attachment of the PSS installation checklist) and handed out to customer. A copy is added to this list.

OK N/A

Accuracy Check

With couch rotated to extreme position 90°, perform a Maneuver Test as described in SM 09-083.

Recalibrate Robotics if necessary and perform the test again.

OK

Recalibrated

9. Safety Technical Inspection (STI)

The safety technical Inspection test demonstrates the electrical and functional safety of the ExacTrac system.

NOTE: The STI for Robotics 1/2 is to be performed as well.

A Safety Technical Inspection (STI) according to Clinical User Guide was performed.

Additional instructions can be found in the service documentation SM 09-087/SM 10- 298.

The results of measurements were documented in the applicable STI-Checklist and handed out to customer. A copy is added to this list.

OK

10. ExacTrac Calibration/Verification

This section is to ensure correct calibration of the ExacTrac IR and X-Ray system.

NOTE: Also refer to the Before-After-Calibration-Test as described in the SM 09-87 ExacTrac 6.x Service Manual (chapter “Calibration Verification and Recalibration”) for even more precise verification of

calibration.

Acquire X-Ray Correction Images (white images/bad pixel images) for both tubes. OK Open the dialog Test Acquisition Dialog and acquire X-rays using the technique of

the white images without anything in the way (couch top, phantoms etc.). The image you get has to be a homogenous white image (without using the windowing or the contrast enhancement tools).

OK

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Put Isocenter Phantom in the Linac isocenter. Open test patient for Video check, use Isocenter Calibration of ExacTrac Software for IR alignment.

1. The video camera is aimed at and focused on the Linac isocenter. Adjust if necessary.

2. IR Camera Alignment: The phantom appears in the center of the field of view.

If phantom is not inside the center, re-align IR camera, recalibrate ExacTrac.

Inform customer (physicists) that the calibration has to be repeated/checked by the customer.

OK Video adjusted IR adjusted

Perform a Daily Check according to the applicable Clinical User Guide (6.0/6.1/6.2/6.5) to verify the ExacTrac calibration.

Select if Daily Check is either successful or if it fails.

Daily Check:

Successful Failed Select if Radiation Isocenter Calibration status is either active (up to date / out of

date) or inactive.

Active Inactive Applicable if first Daily Check failed:

Perform a new ExacTrac Calibration (Isocenter Calibration and X-ray Calibration) according to the applicable Clinical User Guide (6.0/6.1/6.2/6.5).

Inform customer (physicists) that the calibration check failed and calibration has to be repeated/checked by the customer.

OK N/A

Applicable if a new ExacTrac calibration had to be performed:

Perform again a Daily Check. Daily Check is now successful. OK N/A Applicable if ExacTrac calibration had to be performed and Radiation Isocenter

Calibration was active:

Inform customer (physicists) that the Radiation Isocenter Calibration is no longer valid and corresponding calibration procedure has to be performed.

OK N/A

11. Final Positioning Workflow Test

^N/A

This section is not applicable if the customer has ET_MONITORING_STANDALONE license.

This Test bases on the Positioning Workflow Test as described in the Service Manual SM 09-087.

NOTE: Check N/A only if the related feature is not available at this site. Otherwise all tests have to be performed and proper functioning confirmed.

NOTE: Remember to warm up the tubes before starting with test images.

Automatic Prepositioning has been tested. The couch moves normally and reaches the target position (“BMarker”).

Accuracy is max. 2.0mm / half of the slice thickness (larger value applies).

OK N/A

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X-ray images can be acquired without errors and image quality is good. OK N/A

X-ray Fusion is working properly and in normal speed. OK N/A

X-ray Correction: Accuracy is max. 2mm/half slice thickness in first correction. OK N/A

“OK” / “Proceed with X-ray V.” icon is reached once correction shift is fully applied. OK N/A ExacTrac ‘Detect Winston Lutz Pointer’ Test has been performed. Accuracy is max.

1.5mm / half of the slice thickness (larger value applies) in any direction. OK N/A

12. Monitoring Standalone Workflow Test

^N/A

This section is only applicable if the customer has ET_MONITORING_STANDALONE license.

This Test bases on the Monitoring Workflow Test as described in the Service Manual SM 09-087.

NOTE: Remember to warm up the tubes before starting with test images.

X-ray images can be acquired without errors and image quality is good. OK

X-ray Fusion is working properly and in normal speed. OK

Reference Position can be acquired. OK

“OK” icon is reached. OK

The shift beyond the Verification thresholds introduced during this workflow has been

detected. OK

13. Documentation

Final Backup

Applicable for Exactrac Workstation and Prep&Review:

Backup the ExacTrac ini-file to

“exactrac6x_ yyyymmdd_post_PMI.ini”.

NOTE: “x” can be 0, 1, 2 or 5, depending on the version installed.

OK

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Backup harddrive

Applicable for Exactrac Workstation and Prep&Review:

Create a Ghost image file of the current status of the harddrive on the external USB harddrive.

Delete older image files if necessary for storage space, however keep at least one previous version.

In case the Backup harddrive is not stored in the ExacTrac Service Folder, note down the name of the hospital contact person who is in charge of the location of the USB device here:

______________________________________________________

(N/A if no Brainlab backup device available or very recent image on disc already.)

OK N/A

eFSR

Recommendations for the customer and parts that need to be changed or repaired are listed in the Field Service Report.

Please also state in the eFSR if the tasks were performed or not:

 HV cables lubrication

 RTM lubrication

 RTM batteries exchanged

 Protective Earth

 Floor box sealing

OK N/A

Inspection Label

Applicable if the PMI was successful and no safety critical non-conformances were found:

The Brainlab inspection label is completed and attached to the Computer Cabinet front door.

OK N/A

Repair Function Checklist

Applicable if repairs have been performed:

The Repair Function Checklist has been completed as applicable. OK N/A

14. Final Check

Basic SUSeek scan has been completed. OK N/A

iHelp® is installed and a test session could be performed from the PMI Sales Force

Case. OK N/A

NOTE: After completion of the PMI, copies of this ExacTrac 6.x Maintenance and Inspection checklist and of the STI checklists have to be placed in the ExacTrac Service Folder, if available.

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ExacTrac 6.x Maintenance and Inspection Checklist has been completed successfully.

Date (Month/DD/YYYY) Name Signature Brainlab