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Asset Type
Electrocardiograph (EKG) Machine
Manufacturer
Model
Manual Reference
Welch Allyn CP 100 and CP 200 12-Lead Resting Electrocardiograph Service Manual, part number 704340 Rev. D, 2005; applicable Directions for Use.
Manufacturer Recommendation / AEM Status
Welch Allyn recommends a complete functional test every 6-24 months according to hospital protocol. Complete the same test after the unit is dropped or otherwise damaged and when it malfunctions. If functional verification fails, troubleshoot and repair the device, repeat functional verification, or return it to an authorized service center.
Check battery capacity when the battery does not hold a charge and replace it when necessary. Document the facility-selected interval within the manufacturer's 6-24 month range in the CMMS. Manage any interval outside that range through the approved AEM process.
What This PM Procedure Covers
- Identification, configuration, accessories, labels, and physical condition.
- Cleaning and patient-cable/lead inspection.
- AC indication, startup, display, beeper, keyboard, and controls.
- Battery condition, AC/battery operation, and charger performance.
- ECG input and lead-off detection with a simulator.
- Printer test-page and ramp-page verification.
- SD, USB, and optional spirometry communications when used.
- Electrical safety and return-to-service review.
Required Tools and Equipment
- Known-good 12-lead patient cable and leads.
- ECG patient simulator.
- Electrical safety analyzer suitable for IEC 60601-1 or ANSI/AAMI ES1 testing.
- Formatted SD memory card, 64 MB or greater, when testing the SD slot.
- Compatible CardioPerfect workstation and USB A-to-A cable when USB transfer is used.
- Known-good spirometry dongle for CP 2S/CP 2AS configurations when applicable.
- Metric ruler.
- Manufacturer-approved cleaning/disinfection supplies and facility-required PPE.
- Qualified-service equipment for advanced battery, charger, or dielectric testing when required.
Step-by-Step PM Procedure
1. Confirm Identification and Configuration
Action: Verify asset tag, serial number, CP 200 configuration, software version, interpretation/spirometry options, accessories, workstation use, battery history, and facility settings. Confirm the displayed serial number agrees with the case label and print settings when required.
Expected outcome: Identity and installed options match the CMMS record, and configuration-dependent tests are identified.
2. Remove the Device From Clinical Use
Action: Confirm the electrocardiograph is not connected to a patient. Power off and disconnect AC and accessories before cleaning or detailed inspection.
Expected outcome: Maintenance proceeds safely without interrupting patient care.
3. Inspect the Device and Accessories
Action: Inspect enclosure, display, keyboard, softkeys, printer door/latch, paper tray, inlet, cord/plug, equipotential terminal, patient connector, USB/SD/serial ports, mounts, labels, patient cable, lead wires, clips/electrodes, and accessories. Check for cracks, looseness, contamination, corrosion, bent pins, fraying, exposed conductors, fluid entry, overheating, missing hardware, or illegible labels.
Expected outcome: No condition is present that could affect safety, ECG quality, electrical safety, or cleaning.
4. Clean and Disinfect
Action: Clean and disinfect the device, patient cable, leads, and reusable accessories according to the current Directions for Use, accessory instructions, and infection-control policy. Prevent fluid entry and dry all components.
Expected outcome: Equipment is clean, dry, and undamaged.
5. Verify AC Power, Indicator, and Startup
Action: Connect AC and verify the indicator beneath On/Standby illuminates. Power on without an error. Disconnect AC and verify the indicator turns off; reconnect and verify it illuminates.
Expected outcome: AC detection, indication, startup, and power transitions are normal.
6. Verify Display, Beeper, Keyboard, and Controls
Action: From Main Menu > System Settings > Device Info > Service Info, run LCD Test. Confirm a complete, uniform pattern without breaks and usable contrast adjustment. Enable the beeper and confirm an invalid key produces a tone. Test alphanumeric, navigation, softkey, Auto ECG, and other accessible controls, then restore settings.
Expected outcome: Display, contrast, beeper, keyboard, softkeys, navigation, and function controls pass.
7. Evaluate Battery and Charging
Action: Review battery age, condition, charge behavior, and history. With a charged battery, verify continued operation when AC is removed and charging/AC indication when restored. Do not reset battery life unless the battery was replaced and continuously charged for at least 12 hours.
If the battery does not hold charge, qualified service may perform the manual's bench checks:
- At 6.2 +/- 0.05 VDC: no low or critically-low indication.
- At 5.45 +/- 0.05 VDC: critically-low indication followed by shutdown.
- Operating/non-printing current at 6.4 +/- 0.05 VDC: 675-825 mA.
- Standby current: less than 5 mA.
- Fast-charge output: 6.8-7.3 VDC; fast charge off: 6.3-6.8 VDC.
Expected outcome: Battery operation and charging are reliable; replace a battery that cannot hold adequate charge.
8. Verify ECG Input and Lead-Off Detection
Action: Connect a known-good patient cable/leads to an ECG simulator with V1/C1 disconnected. Verify V1/C1 flashes while connected leads do not. Remove LL; verify LL flashes, all V/C leads gray out, and RA, LA, and RL do not flash. Reconnect all leads and verify indications clear and the next screen appears in approximately three seconds. Acquire and print/review a simulated 12-lead ECG; confirm stable waveforms, correct lead identification, expected rate, and no intermittent cable artifact.
Expected outcome: All ECG channels acquire a usable signal and lead-off detection responds correctly.
9. Perform the Printer Test
Action: On AC power, select Main Menu > System Settings > Device Info > Service Info > Printer Test. Print two test pages and use the second to verify:
- Circle arc to top edge: 37 +/- 3 mm.
- Circle arc to left edge: 45 +/- 5 mm.
- Vertical line straight/unbroken; thick black line uniform/unbroken.
- 200 mm line: 200 +/- 4 mm; all printing readable.
- Cue-sensor lead-in/output trail: 19-82 mm below the 200 mm line.
- Cue-sense pattern: 97-135 mm below the 200 mm line.
Run Ramp Page and verify the ramp top cuts off between 250 and 550 on the gauge. Confirm centered tracking without curling, crinkling, skew, or feed errors.
Expected outcome: Output, density, scaling, cue sensing, and paper transport meet the manual's criteria.
10. Verify Data Interfaces When Used
- SD: Run
MMCSDTEST.EXE; confirmMyFile.TXTincrements after approximately 30 seconds and no errors appear. - USB/CardioPerfect: Confirm workstation recognition and successful ECG-record transfer.
- CP 2S/CP 2AS: Attach a known-good spirometry dongle and confirm the Spirometry module opens without error. Maintain the spirometer under its own procedure.
Expected outcome: Every installed, clinically used interface communicates normally.
11. Perform Electrical Safety Testing
Action: Using IEC 60601-1 or ANSI/AAMI ES1 methods and facility procedure, test earth leakage, chassis/enclosure leakage, and patient leakage. Record the analyzer, standard, configuration, results, and applicable limits.
After any procedure that opened the enclosure, qualified service must perform the manual's dielectric/patient-isolation test: 1500 VAC, maximum 5.00 mA, minimum 0.15 mA, 10-second ramp-up, one-minute dwell, and local line frequency. This hazardous test is not routine for an unopened-case PM unless facility policy requires it.
Expected outcome: All applicable electrical-safety tests pass.
12. Restore Settings and Complete Return-to-Service Review
Action: Restore approved settings, beeper, date/time, paper supply, and accessories. Confirm the enclosure is closed, printer ready, and no error or test data remains.
Expected outcome: The CP 200 is correctly configured and ready for clinical use.
Electrical Safety Testing
Record ground resistance in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different.
Touch/chassis leakage measured in microamps:
Facility limit used =
Result =
Pass / Fail =
Also document earth and patient leakage using the applicable standard and facility-approved limits. Perform the specified dielectric test after the enclosure has been opened.
Pass / Fail Criteria
PM Pass Criteria
- Identification, configuration, inspection, labels, cleaning, and accessories pass.
- AC indication, startup, display, beeper, keyboard, softkeys, and controls pass.
- Battery and charging are reliable; advanced values meet listed limits when tested.
- ECG acquisition and lead-off responses pass with the simulator.
- Printer measurements, ramp test, readability, and transport pass.
- Installed and used interfaces pass or are documented N/A.
- Applicable electrical-safety tests pass.
- Settings are restored and no unresolved fault remains.
Remove From Service Criteria
- Physical, cable, lead, connector, label, contamination, or liquid damage affects safety/performance.
- Battery, charger, startup, display, beeper, keyboard, or controls are unreliable.
- ECG acquisition or lead-off detection fails or produces unacceptable artifact.
- Any printer dimension, density, ramp, cue-sensor, or transport check fails.
- A required interface or electrical-safety test fails.
- The unit fails verification, retains an error, or cannot be restored to approved configuration.
Copy/Paste CMMS Work Order Procedure
Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.
