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Manual Reference
Medtronic Capnostream 35 Portable Respiratory Monitor Operator's Manual, document PT00039637A, including Chapter 6, Preventive Maintenance; plus the current Capnostream 35 service manual, software instructions, regional supplements, and Medtronic calibration/maintenance information. Verify the model, software, configuration, clinical environment, and current document revision before service.
Manufacturer Recommendation / AEM Status
- Periodic maintenance: Every 24 months from the installation date.
- Initial CO2 calibration: After the first 1,200 operating hours or 12 months, whichever comes first.
- Subsequent CO2 calibration: Every 4,000 operating hours or 12 months, whichever comes first.
- Calibration Required message: Calibrate within two weeks after the message appears.
- Battery replacement: Medtronic's maintenance reference recommends every 4 years for hospital-use units and every 2 years for EMS-use units.
- Additional service: Perform whenever damage, failed testing, unreliable measurements, abnormal alarms, service messages, or repair history requires it.
The service screen reports CO2 Hours Remaining Before Service, CO2 Hours Remaining Before Calibration, and CO2 Last Calibration. Record those values rather than estimating due dates. A facility interval that changes the manufacturer schedule must be supported by an approved AEM program, risk assessment, service history, applicable regulations, and current Medtronic instructions.
What This PM Procedure Covers
- Identity, software, hospital/EMS use, history, service hours, and calibration status
- Housing, screen, controls, mounting, connectors, FilterLine input, SpO2 port, data ports, power supply, and accessories
- Removable and internal batteries, hot-swap support, charging, and AC operation
- Startup, display, controls, audible/visual alarms, date/time, storage, and configuration
- Microstream CO2 sampling, calibration, authorized 5% gas calibration check, SpO2, pulse rate, and alarm performance
- USB, SD, serial/Ethernet, Wi-Fi/Vital Sync, nurse-call or external interfaces as configured
- Electrical safety, final verification, and CMMS documentation
Required Tools and Equipment
- Current Capnostream 35 operator/service documentation, maintenance reference, software information, and facility PM form
- Manufacturer-authorized CO2 calibration kit with 5% CO2, 21% O2, balance N2 gas, authorized T-piece, and Calibration FilterLine; the manual identifies Scott Medical kit T4653ORF-2BD
- Calibrated pulse-oximetry simulator and compatible Nellcor test cable/sensor setup
- Compatible Microstream FilterLine and sampling accessories
- Calibrated electrical-safety analyzer suitable for the current Medtronic/facility procedure
- Approved AC power supply/cord, known-good removable battery, and external charger as applicable
- Known-good USB or SD media, network test connection, interface cables, and nurse-call test support as configured
- Manufacturer-compatible cleaning supplies and inspection tools
Step-by-Step PM Procedure
1. Remove the Monitor From Patient Use
Action: Confirm the monitor is disconnected from the patient and not supporting active care. Provide a replacement monitor, remove single-patient accessories, and clean the unit according to the current instructions and facility infection-control policy.
Expected outcome: The Capnostream 35 is safely controlled for service, clean, dry, and not relied on clinically.
2. Verify Identity, Configuration, and Environment
Action: Record asset tag, serial number, software version, hospital or EMS use, installed options, power supply, removable/internal battery configuration, SpO2 technology, network/interfaces, mount, charger, and accessories.
Expected outcome: The physical device matches the CMMS record and the correct interval, battery schedule, documentation, and test path are identified.
3. Review History, Hours, and Due Status
Action: Review prior PM, repairs, calibration results, measurement complaints, sampling blockages, battery events, software updates, recalls/field actions, and open corrective work. Open Menu > Setup > Service, enter the authorized service password, and record CO2 Hours Remaining Before Service, CO2 Hours Remaining Before Calibration, and CO2 Last Calibration.
Expected outcome: All required 24-month service, annual/hour-based calibration, battery replacement, updates, and corrective actions are known.
4. Inspect the Monitor and Accessories
Action: Inspect the housing, bumper, handle, screen, front controls, alarm light, speaker openings, labels, seals, feet, battery latches/contacts, mounting plate/clamp, FilterLine inlet, SpO2 port, USB/SD and communication ports, power input/supply/cord, cables, sensors, and charger. Check for cracks, impact, loose parts, contamination, corrosion, fluid entry, bent pins, obstructed openings, or exposed conductors.
Expected outcome: The complete configured system is clean, secure, correctly labeled, and free of damage that could affect measurements, alarms, power, transport, or electrical safety.
5. Verify AC Power, Charging, and Batteries
Action: Confirm the approved power supply and indicator behavior, battery recognition and charging, operation from the removable battery, controlled hot swap/internal-battery support, return to external power, and normal shutdown. Review battery age and replace at 4 years for hospital use or 2 years for EMS use, or earlier for damage, poor runtime, charging faults, swelling, excessive heat, or manufacturer instruction.
Expected outcome: Power transfer is uninterrupted, both installed battery functions operate as intended, charging/indicators are normal, and battery age and condition are acceptable.
6. Perform Startup and User-Interface Checks
Action: Start the monitor and verify boot completion, screen quality, buttons/directional controls, alarm-silence control, status indicators, audible startup tone, alarm light, parameter displays, menus, patient-type selection, date/time, and configured settings. Confirm the device is not left in Demo mode or unintended parameter standby.
Expected outcome: Startup completes without a system error and all controls, displays, indicators, audio, settings, and modes respond correctly.
7. Check Memory, Reports, and Configuration
Action: Verify patient-case handling, event entry, trends, reports, internal storage, date/time retention, and approved institutional defaults. Back up or clear only test data permitted by facility policy.
Expected outcome: Required data is stored, retrieved, time-stamped, and displayed correctly without a memory or configuration fault.
8. Verify the CO2 Sampling Path
Action: Connect a compatible Microstream FilterLine. Verify recognition, sampling-pump operation, waveform/numeric response with an approved test source, pump-off/standby behavior, and recovery after reconnection. Check for blockage, leakage, weak flow, moisture, persistent FilterLine alerts, or a CO2 ERROR.
Expected outcome: The sampling line is recognized promptly, the pump and sampling path operate normally, and stable CO2 waveform/numeric data appears without an unresolved fault.
9. Perform CO2 Calibration When Due
Action: Confirm whether the first 1,200-hour/12-month or subsequent 4,000-hour/12-month interval has been reached. If due, perform calibration using the current authorized service procedure. The manual recommends completion within two weeks of a Calibration Required message.
Expected outcome: Calibration completes successfully, the last-calibration record updates correctly, and no calibration-required or CO2 fault remains.
10. Perform the CO2 Calibration Check
Action: Connect the authorized Calibration FilterLine and kit containing 5% CO2, 21% O2, balance N2 through the approved T-piece. Navigate to Menu > Setup > Service > CO2 Cal, select the calibration-check function, and follow every on-screen instruction for gas connection, flow, completion, shutdown, and results. If battery powered, begin with a fully charged battery.
Expected outcome: The monitor reports a successful calibration check and the result meets the current manual criteria. If it fails or recommends calibration, complete authorized calibration and repeat the check; remove the monitor from service if it still does not pass.
11. Verify SpO2 and Pulse Rate
Action: Connect a calibrated simulator with the compatible Nellcor test interface. Test representative normal and alarm conditions for SpO2 and pulse rate, sensor disconnect/off-patient response, waveform/indicator behavior, and each clinically used patient category according to the current procedure.
Expected outcome: SpO2 and pulse rate display within current manufacturer tolerance and sensor/alarm responses are correct without an SpO2 ERROR.
12. Verify Capnography and Respiration Alarms
Action: Apply controlled CO2/respiration signals and verify EtCO2, FiCO2, respiration rate, waveform, No Breath/apnea, high/low limit, FilterLine disconnect/blockage, and pump or calibration messages. Confirm visual/audible priority, alarm light, volume, silence, delay, reset, and reminder behavior.
Expected outcome: Applied values and waveforms are credible and every required capnography/respiration alarm activates, identifies the condition, sounds/displays correctly, and clears as designed.
13. Verify General Alarm Operation
Action: Test high- and medium-priority visual/audible indications, speaker clarity, alarm light, alarm silence, pulse tone, configured volume minimums, and representative SpO2/pulse and system alarms under controlled non-patient conditions.
Expected outcome: Alarm annunciation is clearly audible and visible, priority and controls behave correctly, and no alarm channel is missing, weak, distorted, or intermittent.
14. Verify Data and Communication Options
Action: As configured, test USB and SD recognition/export, serial or Ethernet adapter, Wi-Fi, Vital Sync/EMR transfer, report output, and nurse-call interface using approved media, cables, networks, and test destinations. Do not alter production credentials unless authorized.
Expected outcome: Each installed data path recognizes the connection and transfers the approved test record correctly without exposing patient information or leaving an unauthorized setting.
15. Perform Electrical Safety Testing
Action: Test the monitor, approved external power supply/cord, charger, mount, and electrically connected interfaces using the current service-manual and facility method. Record analyzer identity, test configuration, current limits, and actual readings; evaluate the complete medical electrical system when external equipment is connected.
Expected outcome: Every required electrical-safety measurement and connected-system configuration passes the documented current criteria.
16. Restore and Return to Service
Action: Remove test equipment, reinstall approved accessories and serviceable batteries, restore institutional settings and approved network configuration, confirm date/time and patient type, run a final startup and functional check, and document readings, gas lot/expiration, parts, corrective work, and disposition.
Expected outcome: The Capnostream 35 is clean, charged, configured, calibrated, fully functional, and either returned to service with traceable results or clearly removed from service.
Electrical Safety Testing
Use the current Capnostream 35 service procedure, the external power supply's classification, the analyzer manufacturer's instructions, and facility policy. The operator manual does not publish one universal PM limit for every stand-alone and connected-system configuration; do not copy the Capnostream 20p serial-port value or generic monitor limits into this procedure.
Electrical-safety analyzer / serial / calibration due:
Result =
Power supply and cord inspection:
Result =
Protective-earth or ground resistance, only if applicable to the tested configuration:
Current limit =
Result in ohms =
Pass / Fail / N/A =
Touch/chassis or enclosure leakage:
Test condition / current limit =
Result in microamps =
Pass / Fail =
Connected medical electrical system:
External equipment/interfaces included =
Method / limits / results =
Pass / Fail / N/A =
Pass / Fail Criteria
Pass
- Identity, software, use environment, history, service hours, calibration status, housing, screen, controls, labels, mount, connectors, power supply, batteries, cables, and accessories are acceptable
- Startup, display, controls, date/time, memory, settings, reports, indicators, and audible/visual alarms pass
- CO2 sampling, pump, FilterLine recognition, waveform/numerics, calibration, authorized calibration check, and capnography alarms pass
- SpO2, pulse rate, sensor detection, and applicable alarms meet current manufacturer criteria
- Installed USB, SD, network, Vital Sync/EMR, reporting, and nurse-call functions pass as applicable
- 24-month maintenance, annual/hour-based CO2 calibration, and hospital/EMS battery replacement requirements are current
- Electrical safety passes using documented current limits and configuration
- No unresolved CO2, SpO2, battery, power, alarm, memory, communication, calibration, or system fault remains
Remove From Service
- Startup, control, display, alarm, CO2 sampling/calibration, SpO2, power/battery, or electrical-safety testing fails
- Housing, screen, connector, port, power supply, cord, battery, sensor, mount, or accessory damage could affect safe operation
- Calibration is overdue, a Calibration Required message remains unresolved, or the calibration check fails after authorized corrective action
- A battery is damaged, swollen, excessively hot, unreliable, below required runtime, or past the applicable replacement interval
- Required current documentation, calibration gas, test equipment, software action, part, or qualified service support is unavailable
- Any unresolved condition could cause missed, delayed, inaccurate, or unannunciated respiratory or oxygenation information
Copy/Paste CMMS Work Order Procedure
Do not service the Capnostream 35 while it is in clinical use. Do not return it to service with overdue calibration, failed CO2 or SpO2 verification, unreliable alarms or power, electrical-safety failure, or any unresolved condition that could produce inaccurate respiratory monitoring.