Model note · Pulse Oximeter
Medtronic Nellcor Bedside SpO2 Patient Monitoring System PM100N
The PM100N is a bedside pulse oximeter for continuous SpO2 and pulse rate monitoring of adults, children and neonates, including poorly perfused patients, in hospitals, hospital type facilities, transport and home care. It uses the same OxiMax oximetry board and algorithm as the earlier N-600x and works with standard Nellcor sensors. SatSeconds alarm management, a 96 hour trend memory and nurse call output are its main ward features.
The model
Maker, model and type.
- Maker
- Covidien LLC (Medtronic)
- Model
- Nellcor Bedside SpO2 Patient Monitoring System PM100N
- Device type
- Pulse Oximeter
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Measurement ranges | SpO2 1 to 100%; pulse rate 20 to 250 bpm; pulse amplitude 0.03 to 20% | Source |
| SpO2 accuracy (70 to 100%, plus or minus 1 SD) | Adult and low perfusion plus or minus 2 digits; neonate plus or minus 3 digits | Source |
| Pulse rate accuracy | Plus or minus 3 digits over 20 to 250 bpm (adult and low perfusion) | Source |
| Trend memory | 96 hours at one sample every 4 seconds, downloadable to a PC | Source |
| Power and battery | 100 to 240 VAC, 50/60 Hz, 45 VA; lithium ion battery, at least 8 h new with no alarms (8 h and 16 h packs offered) | Source |
| Size, weight and ingress | 82 x 255 x 165 mm; 1.6 kg; IPX2 | Source |
| Environment | Operating 5 to 40 C, 15 to 93% RH non condensing, minus 170 to 4877 m | Source |
| Alarm features | High and low SpO2 and pulse rate, backup audible alarm, SatSeconds 10, 25, 50, 100 or off, low battery and sensor off warnings | Source |
| Electrical classification | Internally powered, type BF applied part, continuous operation | Source |
| FDA clearance | K120773 (July 2012), later K142865; product code DQA, Class II, 21 CFR 870.2700; predicate N-600x (K083325) | Source |
Recalls
Known FDA recalls.
- Z-2151-20252025-06-23
Labelling correction (264,790 units) after alarms were not heard or recognised; reiterates alarm volume, sensor off priority and Homecare Mode guidance.
FDA record
Safety
Safety warnings from the record.
- Missed alarms have been linked to treatment delay, unanswered low saturation, respiratory failure and arrhythmia. Source
- Outside Homecare Mode, alarms can be silenced and limits changed, so a monitor sent home must be switched to Homecare Mode and the Home Use Guide given to carers. Source
- Not suitable for use with flammable anaesthetics. Source
Sources
Where this note comes from.
- Medtronic Nellcor Bedside SpO2 Patient Monitoring System product page
- FDA 510(k) K120773 summary, Nellcor Bedside SpO2 Patient Monitoring System
- openFDA recall search, PM100N
- openFDA MAUDE problem counts, model PM100N
Not covered: The operator's and service manuals were not reachable (the hosting library did not resolve and Medtronic's manuals portal was not opened), so the troubleshooting table and numbered error codes are missing; the single entry is the sensor off alert as described in the FDA recall record. The 'sensors' failing part is an interpretation of MAUDE reading codes, flagged as such. Recall records were read through openFDA.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Pulse Oximeter