Medtronic Capnostream 20p

Asset Type

Capnography Monitor

Manufacturer

Medtronic

Model

Capnostream 20p

Manual Reference

Oridion Capnostream 20 Portable Bedside Capnograph/Pulse Oximeter Operator’s Manual, PN 010461E.

Manufacturer Recommendation / AEM Status

The provided operator manual does not provide a full service-manual preventive maintenance checklist. It states that the Capnostream requires no routine service other than performance testing mandated by the operator’s institution, and it directs users to the service manual or local distributor for service instructions, performance tests, and checks.

The manual does list maintenance intervals, calibration intervals, a CO2 calibration check procedure, and electrical safety-related warnings.

Manufacturer-Listed Maintenance and Interval Information

• Routine service: No routine service listed other than institution-mandated performance testing.
• Qualified service interval: Servicing by qualified service personnel once every 20,000 operating hours.
• CO2 pump replacement: Every 20,000 operating hours.
• CO2 calibration: After the first 1,200 operating hours or 12 months, whichever comes first.
• Ongoing CO2 calibration interval: Every 12 months or 4,000 operating hours, whichever comes first.
• Calibration due message: Monitor displays CALIBRATION REQUIRED when calibration is due; the manual recommends calibration within two weeks of that message.
• Battery pack replacement: Recommended every 2 years due to possible Li-ion battery backup-time degradation.
• CO2 calibration check: May be performed at any time depending on institutional policy and procedure.
• Electrical safety note: The manual states to measure leakage current whenever an external device is connected to the serial port, and leakage current must not exceed 100 microamps in that specific condition. Do not treat this as the universal PM leakage limit for every test setup.

AEM note: If a facility performs this PM at a different interval or changes the listed activities, that should be handled under the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.

What This PM Procedure Covers

• Visual inspection
• Power cord and enclosure inspection
• Battery and AC power check
• Service hour and calibration status review
• CO2 calibration check
• SpO2 function check
• CO2 sampling function check
• Alarm and indicator functional check
• Electrical safety testing per facility policy
• Documentation of manufacturer-listed intervals
• Removal-from-service conditions

Required Tools and Equipment

• Electrical safety analyzer
• Manufacturer-authorized CO2 calibration kit
• Calibration gas: 5% CO2, 21% O2, balance N2
• Tubing adapter / “T” piece
• Calibration Line / Calibration FilterLine
• Facility-approved cleaning supplies
• Replacement accessories as needed

The manual lists a manufacturer-approved calibration kit available from Scott Medical, part number 0304653ORFBD, containing calibration gas, tubing adapter, and Calibration Line.

Step-by-Step PM Procedure

1. Confirm Device Identity

Confirm asset tag, serial number, manufacturer, model, and location.

Expected outcome: Device identity matches the CMMS record.

2. Review Manufacturer-Listed Intervals

Review service hours, calibration status, and maintenance interval status.

From the Home screen, select SYSTEM, then SERVICE. The manual states the Service screen shows hours remaining until servicing or calibration is required, and no password is required to see hours before servicing is required.

Document service hours, hours remaining until service, calibration status, last calibration date if available, and next calibration due if available.

3. Visual Inspection

Inspect the monitor exterior, display, buttons, knob, handle, connectors, labels, battery compartment, feet, and mounting condition.

Check for cracked housing, loose or damaged connectors, damaged display, missing or illegible labels, damaged battery door, loose mounting hardware, evidence of fluid ingress, damaged FilterLine input connector, damaged SpO2 connector, and damaged power entry module.

Expected outcome: Monitor is physically intact and safe for use.

4. Power Cord and AC Power Inspection

Inspect the power cord and plug. Confirm the cord is intact and undamaged.

The manual states the device should be connected only to a three-wire grounded hospital-grade receptacle, the grounding connector must not be removed, and the power cord and plug must be intact and undamaged.

Expected outcome: Power cord and plug are intact with no visible damage.

5. Power-On Check

Connect the monitor to AC power. Turn on the rear power switch, then power on the monitor from the front panel.

Confirm the orange AC power indicator illuminates, the green power-on indicator illuminates, the red and yellow alarm lights briefly illuminate during startup, the speaker beeps during startup, and the monitor completes startup without error.

Remove from service if the red/yellow alarm indicators do not light, the speaker does not sound during startup, the unit fails startup, or errors prevent normal monitoring.

6. Battery and AC Power Check

Confirm the battery is installed and verify the battery charge indicator. Confirm the monitor operates on AC power during normal use.

The manual recommends always operating the unit with the battery installed so backup power is available during temporary AC power loss. It also states to confirm the battery charge level and AC power connections before each use.

Document battery installed, battery condition acceptable, and AC power indicator status.

7. CO2 Calibration Check

Perform the CO2 calibration check using the manufacturer-authorized calibration kit.

The manual states the calibration check must be performed with a manufacturer-authorized kit containing 5% CO2, 21% O2, balance N2 and the authorized connecting means / “T” piece.

1. Navigate to CO2 CALIBRATION CHECK.
2. From the Home screen, select SYSTEM, then CAL CHECK.
3. Connect Calibration Line to the monitor.
4. Select START.
5. Connect calibration gas: 5% CO2, 21% O2, balance N2.
6. Open gas supply when prompted.
7. Allow calibration check to complete.
8. Close gas supply when prompted.
9. Disconnect calibration gas and FilterLine when prompted.
10. Record measured CO2 result.

Manual-listed pass range for 5% gas: Measured CO2 expected 4.7% to 5.3%.

If the result is out of specification, the manual states MEASURED CO2 NOT WITHIN SPECIFICATIONS. CALIBRATION RECOMMENDED is displayed and the calibration procedure must be performed by referring to the Service Manual or authorized Oridion service personnel.

8. SpO2 Function Check

Connect an approved Nellcor SpO2 sensor or facility-approved test setup. Confirm the monitor detects the sensor and displays SpO2 / pulse rate appropriately.

Remove from service if the monitor displays persistent SpO2 ERROR or cannot operate the SpO2 function.

9. CO2 Sampling Function Check

Connect a FilterLine or calibration line as appropriate. Confirm the monitor recognizes the line and does not show persistent blockage or CO2 failure messages.

Remove from service if the monitor displays persistent CO2 ERROR, repeated calibration failure, or a persistent fault that prevents CO2 monitoring.

10. Alarm / Indicator Functional Check

Confirm visual and audible alarm indicators function during startup. If facility policy requires it, perform a functional alarm check.

The manual includes a capnography alarm setting test for the No Breath alarm by establishing normal breathing display, then removing the sampling line from the patient’s mouth to create a no-breath condition. For PM use, follow facility policy and do not perform patient-based alarm testing during active patient care.

11. Cleaning

Clean the exterior using a facility-approved cleaning process compatible with the device.

Expected outcome: Device is clean, dry, and ready for use.

Electrical Safety Testing if applicable

Perform electrical safety testing according to facility policy, NFPA 99 criteria, and the electrical safety analyzer procedure used by the facility.

The manual specifically states that leakage current must be measured whenever an external device is connected to the serial port and that leakage current must not exceed 100 microamps in that condition.

Do not use that 100 microamp value as a universal chassis leakage limit unless the test condition matches the manual statement or facility policy requires it.

Ground Resistance

Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different.

Touch / Chassis Leakage

Touch/chassis leakage measured in microamps:

Facility limit used =

Result =

Pass / Fail =

Serial-Port External Device Leakage, if applicable

External device connected to serial port during test: Yes / No

Manual-listed leakage limit when external device is connected to serial port: ≤ 100 microamps

Result =

Pass / Fail =

Pass / Fail Criteria

PM Pass Criteria

• Device passes visual inspection.
• Power cord and plug are intact.
• Unit powers on normally.
• Startup alarm lights and speaker function.
• Battery is installed and acceptable.
• Service/calibration status is reviewed.
• CO2 calibration check result is within 4.7% to 5.3% using 5% CO2 gas.
• Electrical safety testing passes facility criteria.
• No persistent CO2, SpO2, battery, power, or system errors remain.

Remove From Service Criteria

• Housing, connectors, power cord, or plug are damaged.
• Unit fails startup.
• Alarm lights or speaker fail startup check.
• CO2 calibration check is out of specification.
• CO2 calibration check fails repeatedly.
• Persistent CO2 ERROR or SpO2 ERROR is present.
• Electrical safety testing fails.
• Battery condition is unacceptable for facility use.
• Device has reached a service condition requiring authorized service and cannot be cleared through approved facility procedure.

Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.