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Philips SureSigns VS4 Vital Signs Monitor Service Guide, Release A.06, Part Number 4535 645 72701, October 2015. Installed options vary; identify the SpO2 technology, temperature module, CO2 module, recorder, network, and nurse-call configuration before testing.
Manufacturer Recommendation / AEM Status
Philips specifies more than one maintenance interval. Inspect the exterior and labels before use, clean between patients or per facility policy, and perform the IEC 60601-1 safety tests once a year. Verify optional tympanic and temporal temperature modules annually. Perform NBP calibration every two years; perform predictive-temperature accuracy, NBP accuracy, SpO2, and the nurse-call relay every two years or when measurement is suspect. Nurse-call testing applies when that function is used by facility protocol.
Recondition the battery when diagnostic Max Error is 10% or greater. For an installed Microstream CO2 module, perform the first calibration at 1,200 operating hours or one year, whichever comes first; thereafter calibrate every 4,000 hours or annually, whichever comes first, and replace the module at 20,000 hours. Local requirements and required post-repair tests still apply. Do not extend these intervals without a documented, approved AEM assessment.
What This PM Procedure Covers
- Identity, configuration, history, cleaning, enclosure, vents, labels, mount, cord, accessories, battery, and error log
- Power-on self-test, display, LEDs, keys/touchscreen, audio/visual alarms, recorder, and configured communication functions
- NBP static accuracy at 280 and 150 mmHg, pneumatic leakage, calibration when required, SpO2 indication, and configured temperature verification
- Configured CO2 calibration, nurse-call relay, battery thresholds, and annual Class I electrical-safety tests
Required Tools and Equipment
- Current SureSigns VS4 Service Guide and Instructions for Use for the installed hardware/software
- Reference manometer accurate to 0.2% of reading, hand pump/valve, 250 mL ±10% expansion chamber, and appropriate NBP tubing
- Approved adult SpO2 sensor; compatible patient simulator if the manual-directed finger check is inconclusive
- SureSigns predictive temperature probe and calibration key, part 4535 640 33691, when that module is installed
- Covidien calibration device 303079 for an installed tympanic module, or Exergen calibration-verification kit for an installed temporal module
- For installed CO2: electronic flowmeter M1026-60144, 5% CO2 Cal 1 gas 15210-64010, regulator M2267A, and calibration tube 13907A
- Patient simulator, ohmmeter, and phono connector when nurse call is configured and used
- Calibrated electrical-safety analyzer/multimeter suitable for IEC/UL 60601-1 Class I testing
- Approved cleaning/disinfection supplies and known-good Philips-compatible accessories
Step-by-Step PM Procedure
1. Remove the Monitor From Clinical Use
Action: Confirm no patient is connected or dependent on the monitor. End monitoring, remove patient accessories, identify the monitor as under service, and move it to a controlled test area.
Expected outcome: The VS4 is safely controlled for PM with no patient exposure to test signals or alarms.
2. Verify Identity, Configuration, and Due Work
Action: Record asset tag, serial number, department, hardware ID, software version, line frequency, configuration string, installed SpO2 technology, temperature option, CO2 hours, and PM due date. Confirm which annual, two-year, hour-based, condition-based, and post-repair tasks apply.
Expected outcome: The CMMS record and physical configuration agree, and no required option-specific test is omitted.
3. Review History and Error Log
Action: Review prior PM, repairs, impact/liquid events, measurement complaints, battery issues, nuisance alarms, network/nurse-call complaints, and electrical-safety results. View the diagnostic Error Log and investigate unresolved or recurring errors before continuing.
Expected outcome: Known risks and repair-triggered verification requirements are identified.
4. Clean and Dry the Monitor
Action: Follow the current Instructions for Use using only Philips-approved agents. Disconnect mains and accessories first; prevent liquid entry through vents, connectors, recorder, or seams, and allow the monitor and accessories to dry completely.
Expected outcome: The monitor is clean, dry, and free of residue or liquid intrusion.
5. Perform the Visual and Mechanical Inspection
Action: Inspect the enclosure, display/touch surface, keys, navigation wheel, handle, feet, stand/cart attachment, vents, recorder, battery door, connectors, fuses, labels, cord, plug, strain relief, cuffs, hoses, probes, sensors, and cables. Ensure vents are free of dust and no mechanical part is obstructed.
Expected outcome: No crack, break, cut, kink, contamination, loose part, obstruction, missing label, or unauthorized accessory is present.
6. Inspect Battery Status
Action: In Battery Info, record manufacture date, cycle count, Max Error, relative/absolute charge, full capacity, design capacity, voltage, current, and temperature. Inspect for swelling, leakage, heat damage, or connection problems.
Expected outcome: The battery is physically safe and reports valid diagnostic data.
7. Recondition or Replace the Battery When Indicated
Action: Recondition when Max Error is ≥10% by following the service-guide discharge/recharge procedure. Replace a damaged/leaking battery, a battery providing less than one hour before Low Batt after reconditioning, one whose Max Error cannot be reduced to ≤8% after several cycles, or one whose Full Capacity is ≤50% of Design Capacity.
Expected outcome: Battery indication is reliable and all manufacturer replacement thresholds are satisfied.
8. Perform the Power-On Self-Test
Action: Connect to grounded hospital-grade mains and start the monitor. Verify the color bars, brief LCD-off/charging-LED stage, Philips screen, startup tone, and main screen appear in the documented sequence without a persistent technical alarm.
Expected outcome: Startup completes normally and the main screen is stable.
9. Exercise the User Interface and Diagnostics
Action: Run the diagnostic self, display, LED, key/navigation-wheel, audio, and recorder tests as applicable. Verify the touchscreen calibration, date/time, settings, configured ports, and network indication without leaving the monitor in Demo mode.
Expected outcome: Display, input controls, annunciators, speaker, recorder, clock, and configured interfaces operate correctly.
10. Test Visual and Audible Alarms
Action: Ensure alarms and NBP alarms are enabled. Connect an NBP hose without placing the cuff on a person, initiate NBP, and verify an NBP error message and audible alarm occur. Confirm alarm visibility and audio from normal operating positions.
Expected outcome: The monitor detects the failed NBP cycle and produces the appropriate visual and audible alarm.
11. Verify SpO2 Performance
Action: If SpO2 is installed, connect the correct adult sensor, confirm its emitter illuminates, and perform the service-guide check. A stable healthy-adult reading should display 95–100%; if not, repeat with an appropriate patient simulator and follow the module-specific instructions.
Expected outcome: SpO2 acquisition and alarm behavior are stable and consistent with the approved test method. A functional tester alone is not used to claim total pulse-oximeter accuracy.
12. Perform the NBP Accuracy Test
Action: Connect the 0.2%-accuracy reference manometer, pump, valve, tubing, and 250 mL ±10% expansion chamber. In NBP Test, start Static Pressure Test, apply 280 mmHg, stabilize 10 seconds, and record the displayed value; repeat at 150 mmHg.
Expected outcome: The monitor reads 280 ±3 mmHg and 150 ±3 mmHg. If either error exceeds 3 mmHg, calibrate the NBP module and repeat the accuracy test.
13. Perform the NBP Pneumatic-Leakage Test
Action: In Static Pressure Test, raise pressure to 280 mmHg, allow 10 seconds to stabilize, record P1, wait 60 seconds, record P2, and calculate P1 minus P2. Rule out leaks in the external setup before condemning the monitor.
Expected outcome: Pressure loss is ≤6 mmHg in 60 seconds.
14. Verify the Installed Temperature Option
Action: For predictive temperature, use the SureSigns probe and calibration key and verify the static reading. Annually verify an installed tympanic module with the Covidien device or through Philips, and an installed temporal module with the Exergen kit or through Philips, following the applicable manufacturer instructions.
Expected outcome: Predictive temperature reads 36.3 °C ±0.1 °C (97.3 °F ±0.2 °F). Tympanic/temporal modules pass their approved annual verification.
15. Calibrate the Installed CO2 Module When Due
Action: If Microstream CO2 is installed, record usage time, last calibration, hours to calibration, and hours to service. Using the specified 5% gas and accessories, run Calibration Check and calibrate if required. Do not perform the initial calibration before 720 hours. Observe compressed-gas safety and set correct date/time before calibration.
Expected outcome: Calibration check/calibration completes successfully; due counters update. The first calibration occurs by 1,200 hours or one year, later calibrations by 4,000 hours or one year, and a 20,000-hour module is replaced.
16. Test the Nurse-Call Relay When Applicable
Action: If facility protocol uses nurse call, connect the phono plug and ohmmeter and use a patient simulator to create alarm/no-alarm states. Verify tip (normally open), ring (normally closed), and sleeve (common) operation.
Expected outcome: During alarm, tip-to-common is closed and ring-to-common is open; without alarm, tip-to-common is open and ring-to-common is closed.
17. Perform Annual Electrical-Safety Tests
Action: Perform enclosure leakage, protective-earth continuity, and patient leakage with mains on the applied part using the service-guide setups and the locally adopted IEC/UL 60601-1 method. Test required polarities and fault conditions. Recheck leakage whenever an external device is connected to the serial port.
Expected outcome: All measurements meet the limits in the Electrical Safety Testing section.
18. Restore and Document
Action: Exit service menus, ensure Demo mode is off, restore approved accessories and facility settings, clear only data authorized by policy, verify charging and normal operation, clean the monitor, and document all readings, options, parts, calibration, and disposition.
Expected outcome: The VS4 is complete, correctly configured, electrically safe, and either returned to service with traceable results or clearly removed from service.
Electrical Safety Testing
The SureSigns VS4 is Class I equipment. Perform safety testing annually, after impact damage, and after repairs where the front and back are separated. Apply local requirements in addition to the service-guide tests:
- Enclosure leakage, normal condition: ≤100 µA
- Enclosure leakage, open-earth single fault: ≤500 µA under IEC 60601-1 or ≤300 µA under UL 60601-1
- Protective-earth continuity: ≤100 mΩ with mains cable, using 25 A for 5–10 seconds
- Patient leakage with mains on applied part: ≤50 µA at 250 V for every measurement input and required polarity/switch condition
- Serial-port external-device warning: total leakage must not exceed 100 µA whenever an external device is connected
Record analyzer identity/calibration, standard and edition, applied-part configuration, polarity/fault state, highest measured value, limit, and pass/fail status.
Pass / Fail Criteria
PM Pass Criteria
- Identity/configuration, enclosure, vents, labels, mount, cord, accessories, battery, and error history pass
- Power-on sequence, display, LEDs, controls, audio/visual alarms, recorder, and configured interfaces pass
- NBP reads 280 ±3 and 150 ±3 mmHg; pneumatic loss is ≤6 mmHg in 60 seconds
- Configured SpO2, temperature, CO2, and nurse-call tests pass at their applicable intervals
- Battery is safe and does not meet any replacement threshold
- All electrical-safety measurements meet the manufacturer/local limits and Demo mode is off
Remove From Service Criteria
- Cracked/wet enclosure, obstructed vents, illegible required labels, damaged mains/protective earth, unsafe mount, damaged accessory, swollen/leaking battery, or unresolved error
- Failed startup, display/control, speaker/alarm, recorder, configuration, measurement, network, or nurse-call function required for use
- NBP error exceeds ±3 mmHg after calibration or pneumatic loss exceeds 6 mmHg after the external setup is verified
- Any configured temperature/SpO2/CO2 test fails, CO2 calibration cannot complete, or the CO2 module has reached 20,000 hours
- Any electrical-safety result exceeds the applicable limit or required post-repair testing is incomplete
Copy/Paste CMMS Work Order Procedure
Use the current Philips documentation and qualified biomedical service personnel. Apply only the tests for the installed options, but do not omit annual safety testing or any configuration-specific task that is due. Never connect a patient during service testing, and never return a failed monitor to clinical use.