Planned Maintenance 2

ACUSON / SONOLINE US

Maintenance Instructions System Planned Maintenance

This document is valid for: See page 5 © Siemens, 2010

The protocol US00-000.832.01.11.02 is required for these instructions 10433816 10428841 10348533 10348532 10348531 10132987 10131662 10131661 10041461 10041304 10041008 10040872 10040729 10040728 10040725 10040724 10039263 10039262 10038837 10038836 10038605 10038242 10038241 10038202 10037593 10037592 10037591 10037409 10035428 10035427 10034468 10034261 10033701 10033666 10033323 10032747 10032746 10031207 10031205 10029258 10021500 08659422 08653771 08648375 08647831 08647815 08358686 08269627 08267697 08267219 08264604 08261534 08261531 08255417 08255416 08255413 08255412 08253683 08247888 08247887 08246951 08245875 07848547 07848539 07848521 07482826 07482818 07482800 07482479 07478147 07478139 07301604 07301588 07294189 07294163 05936518 05931048 05931030 05931022 05931014 05927244 05927236 05927210 05927202 05684761 05684753 05277475 05277467 05277459 05277442 05277434 05277426 05133330 04904152 04900606 04900598 04900580 04900572 04900564 04900556 04900549 04525700 04525692 04525684 04525676 04525411 04525403 04514209 04514191 04399734 04399726 04399718

© Siemens, 2010 BJ Siemens

US00-000.831.01.11.02 US00-000.831.01.10.02 n.a.

Print No.: Replaces: Part No.: Ultrasound

All documents may only be used for rendering services on Siemens Healthcare Products. Any document in electronic form may be printed once. Copy and distribution of electronic documents and hardcopies is prohibited. Offenders will be liable for damages. All other rights are reserved.

English Doc. Gen. Date: 10.10 n.a.

2010

2

Copyright / Version / Disclaimer

1Copyright / Version / Disclaimer

Copyright “© Siemens, 2010“ refers to the copyright of a Siemens entity such as Siemens Aktiengesellschaft - Germany, Siemens Mindit Magnetic Resonance Ltd. - China, Siemens Shanghai Medical Equipment Ltd. - China, Siemens Medical Solutions USA Inc. - USA and/or Siemens Healthcare Diagnostics Inc. - USA. Document Version Siemens reserves the right to change its products and services at any time. In addition, manuals are subject to change without notice. The hardcopy documents correspond to the version at the time of system delivery and/or printout. Versions to hardcopy documentation are not automatically distributed. Please contact your local Siemens office to order current version or refer to our website http://www.healthcare.siemens.com. Disclaimer Siemens provides this documentation “as is“ without the assumption of any liability under any theory of law. The installation and service of equipment described herein requires superior understanding of our equipment and may only be performed by qualified personnel who are specially trained for such installation and/or service.

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Page 2 of 18 Ultrasound

© Siemens, 2010

Table of Contents 0

3

Table of Contents

1________ Planned Maintenance _____________________________________________ 4 Affected Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Performing Planned Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Required Tools, Materials, and Documents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Reference Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Performing Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 General System Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Functional System Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Network Setup Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Peripheral Devices Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Concluding the Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2________ Changes to Previous Version _____________________________________ 18

© Siemens, 2010

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Planned Maintenance

1

1-

1.1

Affected Systems

Planned Maintenance

This document is valid for:

• ACUSON - Antares family, Aspen, CV70, Cypress family, Sequoia, XP systems, X300, X300 PE, X150, X500, S2000, SC2000, Sonovista FX, S2000 ABVS

• SONOLINE - Adara, Antares family, Elegra, G20, G40 family, G50, G60 S family, Omnia, Premier, Prima, Sienna, Versa Plus, and Versa Pro systems

• SONOVISTA - G40 systems, X300, X500

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© Siemens, 2010

Planned Maintenance 1.2

5

Introduction Planned maintenance (PM) is recurring and should be performed at least every 12 months. The PM includes visual inspections, cleaning, functional performance checks of the system and peripherals. Prior to visiting the customer site for the PM, ask the customer to archive the patient database and perform a disk defragmentation (where applicable). After performing the PM, a Maintenance Protocol must be completed. Distribute a copy of the completed Maintenance Protocol to the customer, the country Service Office, and the Customer Service Engineer’s (CSE) record, as required by the Country Service Organization. Some regions have regulations that require planned maintenance more frequently. It is the responsibility of the CSE to be aware of and adhere to all local regulations regarding planned maintenance intervals for this system and peripherals.

1.2.1

Performing Planned Maintenance While performing a PM, if any of the tests fail, document the failure and do the following:

• If the customer is covered under the equivalent of a full service agreement (such as a Performance TOP or Shared BASIC plan): a) Repair the defect and repeat the test. b) Document the repair and the test results. c) If it passes the test, check Passed in the Maintenance Protocol.

• If the customer is not covered under the equivalent of a full service agreement (such as Shared ADVANCED or EXPERT, Performance PLUS or PRO plans, or no service agreement), discuss the failure and the expected cost of repair with the customer. - If the customer requests the repair, obtain a customer purchase order authorizing the billable work, perform the repair, and repeat the test. Document the repairs and the test results. - If the customer does not desire the repair, or does not issue a purchase order authorizing the billable work, do not perform the repair. Check Failed on the Maintenance Protocol and make a note in the open issues section.

© Siemens, 2010

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Planned Maintenance

1.3

Required Tools, Materials, and Documents

1.3.1

Tools The following tools should be available in the Ultrasound department. If not, the CSE will need to bring the following items:

• • • •

1.3.2

Standard field service tools Ultrasound phantom (optional) Optimization tool kit (P/N 10438124) Eye-One Display 2, S2000 (P/N 10438125)

Materials The CSE will need to bring the following items:

• Lint-free alcohol wipes • Ultrasound gel • Scanning lotion for ABVS

1.3.3

Reference Documents • (US00-002.860.01 / Field Electrical Safety Test Procedure) • Electrical Safety Test Limits: use the platform-specific Electrical Safety Test Limits found in the Safety section of the CB-DOC.

• (US00-000.832.01 / Planned Maintenance) • System specific verification procedure. • FPD Optimization procedure (US15-105.842.01 / Flat Panel Display (FPD) Optimization Procedure - RM200)

1.3.4

Acronyms Abbr.

Explanation

Abb.

Explanation

SI

Safety Inspection

PMF

Preventive Maintenance, Operating Value Check, Function Check

SIE

Electrical Safety Inspection

Q

System Quality, Image Quality

SIM

Mechanical Safety Inspection

QIQ

Image Quality

PM

Preventive Maintenance

QSQ

System Quality Check

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© Siemens, 2010

Planned Maintenance

7

Abbr.

Explanation

Abb.

Explanation

PMP

Periodic Preventive Maintenance

SW

Software Maintenance

PMA

Preventive Maintenance Adjustments

CSE

Customer Service Engineer

ABVS

Automatic Breast Volume Scanner

MPTA

Micro-pinless Test Assembly

© Siemens, 2010

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Planned Maintenance

1.4

Preparations WARNING

Some ultrasound parts may have had patient contact, exposing them to blood borne pathogens. ¹ When handling parts that may have had patient contact, take appropriate precautions against exposure to blood borne pathogens.

PM

Discuss Customer Concerns NOTE

Be aware of billing implications for the site. If parts and labor are not covered by warranty or contract, ensure that you have the customer's permission before performing any work or repairs for which the customer will be billed.

1. Perform the following: a) Discuss with the customer how the system has performed. b) Find out about the concerns that the customer might have regarding the system. c) Fill out the appropriate section of the Maintenance Protocol to document customer concerns and the actions taken to resolve the issues. 2. If the customer has concerns in regards to system performance, steps may be required to address this. If there are no concerns, skip this step and proceed to the next step. PM

Maintain the Patient Database NOTE

This may not apply to all US systems. The ultrasound system is not designed to be an archive system. A full Patient Database will slow down operation of the system.

Discuss with the customer whether there are unused studies present on the system. If there are, work with the customer to either send the unused studies to a storage device or delete the unused studies. PM

Perform Disk Maintenance As directed in the platform specific system verification procedure.

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© Siemens, 2010


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Performing Maintenance PM

System History Analysis Review your notes from interviewing the customer. Define reported failures in order to correlate results with the system logs and any subsequent diagnostic findings. Review the system Logs for errors. Obtain dates and times reported for any problems. Record details of problems found when reviewing logs.

PM

Perform System Diagnostics Checks Check the system integrity by performing system diagnostics checks. Refer to the associated US system Expert Service Manual for instructions on running the checks.

PM

Perform System Calibration (where applicable) Perform required calibration procedures as directed in the platform specific system verification procedure.

PM

Clean the System Use a soft cloth, lightly moistened with a mild detergent solution, to clean the surface of the system, including the system control panel, trackball, transducer holders, system side panels, and any on-board OEM peripheral devices. Refer to the operating instructions for additional information on cleaning the system, transducers, etc.

CAUTION

Do not use alcohol or other organic solvents, or cleansing agents that contain alcohol or other organic solvents to clean the system. ¹ Damage to the system can result if alcohol or solvents are used.

PM

Clean and Inspect Transducers NOTE

CAUTION

Perform leakage test in accordance with (US00-002.860.01 / Leakage Test: Transducer).

[For ABVS] Transducer and Scan Motor Failure May Occur Using normal Ultrasound scanning gel can result in transducer and or scan motor failure. Use only ABVS scanning lotion. ¹ Use only ABVS scanning lotion only.

Perform the following checks for each transducer:

© Siemens, 2010

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Planned Maintenance 1. Clean each transducer with a soft cloth dampened with a mild detergent solution. Take care not to contaminate the transducer connector. Do not clean the transducer head with isopropyl alcohol or other organic solvents. Do not allow the transducer cable and connector to become very wet.

CAUTION

¹ Damage to the transducer can result if alcohol or solvents are used. 2. Check the transducer heads for physical damage such as cracks, splits, or any other malfunction that may affect their performance. Inspect the cable and the connection at the strain relief on both ends of the cable. WARNING

Some ultrasound parts may have had patient contact, exposing them to blood borne pathogens. ¹ When handling parts that may have had patient contact, take appropriate precautions against exposure to blood borne pathogens.

WARNING

The outer surfaces of an endocavity or intra-operative transducer should be checked to ensure there are no unintended rough surfaces, sharp edges, or protrusions that may cause a safety hazard. ¹ Check the outer surfaces of an endocavity or intraoperative transducer.

3. Inspect all transducers and user accessible ports for cleanliness, damage, loose connectors, bent pins, etc. 4. Using a lint-free alcohol wipe, carefully clean the transducer connector to remove dirt, debris or dried gel. 5. [For ABVS] Visually inspect transducer cable at the Column Arm carrier for ware and tear. Refer to Figure 15 of (US15-103.841.01 / Routing the Transducer Cable). PM

Clean Air Filters Clean or replace air filters as necessary.

PM

Clean the Trackball Clean or replace the trackball.

PM

Check Monitor / Flat Panel Display (FPD) Verify that the monitor/FPD is securely mounted on the system, and that the tilt/swivel mechanisms work as designed.

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© Siemens, 2010

Planned Maintenance PM

11

Perform Monitor Optimization Procedure NOTE

This Optimization procedure applies to S2000 systems with software version 2.0 or higher.

Whenever the FPD requires replacement, the monitor optimization procedure will have to be completed following replacement of FPD. Refer to (US15-105.842.01 / Flat Panel Display (FPD) Optimization Procedure - RM200) PM

Calibrate the ABVS LCD Run the ABVS calibration on the LCD as necessary.

PM

Clean the ABVS POD Clean the ABVS POD.

PM

Check Movement of User Controls Verify keyboard/UI and control panel moves as designed (where applicable).

PM

Check Mechanical Operation 1. Verify that the following groups of controls (where applicable) are complete and undamaged, operate freely and correctly and are not clogged with debris or gel: - Keyboard and UI controls - Monitor Controls - ECG Controls 2. Verify transducer holders and inserts function correctly. - For systems with a “Park” position is available, verify the transducer is retained securely. - Verify secondary barrier doors operate freely and close completely. - Verify caps and bezels are intact. 3. Verify the mechanical operation of the doors and user-accessible parts. 4. [For ABVS] Verify the free movement and bearing operation of the ABVS arm Joint A (p/n 10434972), and Joint B (p/n 10434971), and conduct brake checks. 5. [For ABVS] Inspect Counterweight Cables for wear. 6. [For ABVS] Verify proper operation of the ABVS upper (p/n 10434988) and lower (p/n 10434989) Curtains. 7. [For ABVS] Inspect and adjust as necessary the Drive Unit Mounted Assembly (p/n 1044985). 8. [For ABVS] Inspect the Boom Arm for drift. If the Boom Arm moves freely without friction, adjust or replace the Boom Drift Pins.

© Siemens, 2010

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Planned Maintenance

1.6

Safety Checks SI

Check Wheels and Wheel Locks 1. Check the wheels and wheel locks for damage. 2. Verify brakes/steering function as designed.

SI

Check Cooling Fans Power on the system and check that the cooling fans are functioning correctly.

SI

Check the Power Cord Check the AC power cord for signs of wear, heating, or any other signs of malfunction or damage.

SI

Check Electrical Safety Perform electrical safety checks1 (see (US00-002.860.01 / Field Electrical Safety Test Procedure), (US00-001.860.01 / Field Electrical Safety Report), and the Electrical Safety Test Limits: use the platform-specific Electrical Safety Test Limits found in the Safety section of the CB-DOC.

SI

[For ABVS] Permanent Mounting Fixtures For systems that are permanently mounted, check mounting bolts to ensure system is securely mounted to the floor.

SI

Check ABVS Brakes Power on ABVS, listen for brake sounds, and run brake diagnostics.

1. Electrical safety testing is not required unless a primary electrical component has been replaced. primary electrical components are found in the AC subsystem of the ultrasound system.

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© Siemens, 2010


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General System Maintenance PM

Check Modules and Cables With the system powered off, verify all modules are properly secured and that all cables are properly connected.

PM

Check Mandatory/Non-Mandatory System Modifications Verify all mandatory system modifications have been performed. Refer to the (Siemens Customer Services Intranet site, http://cs.med.siemens.de/cms/productinfo/default.asp?startfolder=e1e5c5c57686ca3cdf4a4754e0148d44) for more information. Refer to the (Siemens Customer Services Intranet site, http://cs.med.siemens.de/cms/productinfo/default.asp?startfolder=e1e5c5c57686ca3cdf4a4754e0148d44) for applicable non-mandatory system modifications. Schedule these as required with the customer.

PM

Check Loctite Usage During Assembly/Disassembly Procedures [For ABVS] Add loctite (#242) to screws that have metal to metal contact, excluding all earth ground connections during any assembly/disassembly in the field.

© Siemens, 2010

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Planned Maintenance

1.8

Functional System Check QSQ

Check the System 1. Power on the system. 2. Verify that the system initializes in the appropriate time and displays the image screen. 3. Record the system software version on the Maintenance Protocol. 4. Verify all connected transducers are properly recognized when selected. 5. Verify the trackball is functioning smoothly. 6. Verify the operation of all modes 2D (B) mode, M mode, and C mode. a) Verify Doppler waveform and audio in both directions 7. Functionally test all operator controls and indicators, including the alphanumeric keyboard and the touch panel. Verify the appropriate LED indicators illuminate. 8. Check the system time and date. 9. Verify the CD/DVD-R / MO drive is working properly by archiving a patient study to the disc, then retrieving the patient study from the disc. 10. Verify installed features are working properly. 11. Perform a backup of System and Preset data as required by each system to their respective Customer and CSE Service Backup Disk.

QSQ

Check Image Quality and Transducers For each site transducer, verify the following: 1. Use the Service-specified tissue-mimicking phantom, or equivalent, and check the near field in 2D imaging. 2. Look for dropout and lines in the image near the transducer face (dark columns emanating into the image). 3. While scanning, flex the cable at the strain relief and verify that the image quality is not affected. 4. Check the Freeze function using all applicable transducers, the control panel, and the foots witch (if installed). 5. Correlate results with any diagnostic problems. If any diagnostic problems are found, record the images for return with the Transducer.

QSQ

Check Air Filter For systems with air filters perform the following: 1. Clean or replace the air filter as required, or every six months. Refer to the User Manual.

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© Siemens, 2010


15

Network Setup Check PMF

Verify Network Settings (if applicable) If the system is connected to a network. Verify that the Network settings match the customer’s requirements.

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Planned Maintenance

1.10

Peripheral Devices Check Siemens recommends to clean and check peripheral operation for Siemens-supplied peripherals. Additional information on peripherals settings can be found in Installation > Peripherals. 1. Perform verification and planned maintenance of the Siemens installed peripherals at the site. 2. On the checklist, check only those installed. These may include but are not limited to: - Page Printer - VCR - DVR

QSQ

B/W and Color Video Printers 1. Freeze an image and test each printer by making a print of the image. 2. If necessary, optimize printer settings together with the customer. Refer to the applicable Expert Service Manual for more information on optimizing settings.

QSQ

VCR and/or DVR 1. Test the VCR and/or DVR by recording an image and playing it back. 2. Check the Doppler audio and verify it is being recorded and played back. 3. Verify the microphone operation. 4. If necessary, clean and test the VCR and/or DVR according to the OEM’s operating instructions.

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© Siemens, 2010

Planned Maintenance 1.11 PM

17

Concluding the Maintenance Check System / Preset Data (Backup) Perform a backup of System and Preset data as required by each system to their respective Customer and CSE Service Backup Disk (where applicable).

PM

Concluding the Maintenance 1. Discuss with the customer the maintenance findings and any items noted in the included Maintenance Protocol. 2. Obtain the customer’s signature on the Maintenance Protocol. 3. Give the customer the completed Maintenance Protocol, and return a copy to the Regional Service Office or Home Office, as appropriate to the region. Additional copies may be distributed, as required, by the Country Service Organization. NOTE

© Siemens, 2010

Keep as a CSE record, a copy of the completed Maintenance Protocol.

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Changes to Previous Version 2-

Changes to Previous Version Change(s)

Description

Revision 11

Added p/n 10438125 Eye-One Display 2 to tools list. Removed references to MPTA;

Revision 10

Added PM and references for FPD Optimization procedure. Added FPD Optimization tool kit to Tools list, and procedural document to Reference list.

Revision 09; added additional PMs for ABVS.

Added Joint A and B, curtain operation, drive unit, counterweight cables and transducer cable inspections for ABVS

Revision 08; updated to include Added new product ABVS for S2000. Added ABVS product Scanning lotion for ABVS to 1.3.2; added NOTE to page 6; added various PMs and SIs for ABVS system. Updated to add signature block Added signature block between section 1.4 and and add product Material Num- 1.5 bers Updated document to include new products.

Added new products, ACUSON X300, ACUSON X500, X150, and SONOVISTA X500.

Updated document to include minor deletions and changes.

Deleted check electrical safety SI (section 1.5); modified various section PMs.

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© Siemens, 2010

Planned Maintenance 2

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