Model note · Pulse Oximeter
Nonin Onyx Vantage 9590 Finger Pulse Oximeter
The Onyx Vantage 9590 is a sealed fingertip pulse oximeter for spot checks of SpO2 and pulse rate on adults and children with fingers 0.8 to 2.5 cm thick. It runs on two AAA cells, switches on when a finger is inserted, and shows signal quality on a three colour LED. It has no alarms, is not repairable in the field and needs no calibration beyond battery changes.
The model
Maker, model and type.
- Maker
- Nonin Medical, Inc.
- Model
- Onyx Vantage 9590 Finger Pulse Oximeter
- Device type
- Pulse Oximeter
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Display ranges | SpO2 0 to 100%; pulse rate 18 to 321 bpm | Source |
| SpO2 accuracy (Arms, no motion) | Finger plus or minus 2 digits at 70 to 100%; low perfusion plus or minus 2 digits | Source |
| Pulse rate accuracy | Plus or minus 3 digits at 20 to 250 bpm; low perfusion plus or minus 3 digits at 40 to 240 bpm | Source |
| Optical emitters | Red 660 nm (0.8 mW max average); infrared 910 nm (1.2 mW max average) | Source |
| Battery | Two 1.5 V AAA alkaline cells, about 6,000 spot checks or 36 h continuous use | Source |
| Environment | Operating minus 5 to 40 C, 10 to 90% RH, up to 4000 m; hyperbaric use to 4 atmospheres | Source |
| Classification | Type BF applied part, IP32, continuous operation; ISO 80601-2-61; not defibrillation proof | Source |
| Averaging and response | 4 beat exponential average with 2 beat latency for SpO2 and pulse rate | Source |
| Expected service life | 5 years | Source |
| FDA clearance | K112843, cleared 19 April 2012 (cited as predicate in K131021); product code DQA | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- No audible alarms: for spot checks only. Source
- Do not use in MRI, in explosive atmospheres or on neonates. Source
- Readings can be degraded by motion, bright light, nail polish, dyes, carboxy or methaemoglobin, anaemia and a cuff or line on the same arm. Source
- Check the finger site at least every 4 hours if left on, and avoid extra pressure on the sensor. Source
- Keep phones and radios at least 30 cm away, and expect interference from electrosurgery. Source
Sources
Where this note comes from.
- Nonin Onyx Vantage 9590 support and specifications page
- Nonin Onyx Vantage 9590 Operator's Manual 113634-001-01 (English)
- FDA 510(k) K131021 summary (Nonin 3230, cites 9590 clearance K112843)
- openFDA recall search, Nonin
Not covered: No FDA recall names the 9590; Nonin's four recalls cover other models. MAUDE counts filtered by model number 9590 appear to mix in unrelated devices (several are lab test result codes), so no MAUDE trend is given. The 9590's own 510(k) summary (K112843) was not opened; the clearance date is taken from a later Nonin summary. The 'housing seals and optics' entry reflects manual cautions, not failure data.
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