(164 days)
Med-link Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.
Med-Link Pulse Oximeter is to spot-check oxygen saturation in blood (SpO2) and pulse oximeter is used on adults and pediatrics at hospital, clinics, and/or home. The device mainly consists of power supply module, detector and emitter LED, signal collection and processor module, user interface and button control. There is no visual or audio alarm. The device is reusable and non-sterile. The device has AM801. The device contains a dual light source (Red LED and Infrared red LED) and a photo detector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed in an oxygen saturation measurement (SpO2). Because a measurement of SpO2 is dependent on light from the device, excessive ambient light can interfere with this measurement. The wavelength of red LED is 660mm and infrated LED is 905nm with maximum optical output power of 15mW.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Std. ISO 80601-2-61) | Reported Device Performance (Med-link Pulse Oximeter) | Pass/Fail |
|---|---|---|---|
| SpO2 Accuracy | ARMS value ≤ 3% within the range of 70-100% SaO2 (per ISO 80601-2-61) | Overall ARMS value ≤ 3% within the range of 70-100% SaO2 | Pass |
| SpO2 Range | (Implied by accuracy testing range) 70-100% | 70% to 100% | Pass |
| SpO2 Resolution | Not explicitly stated as acceptance criteria, but common for pulse oximeters is 1% | 1% | Pass |
| SpO2 Accuracy (good perfusion) | 90% to 100% range: ±2%; 70% to 89% range: ±3%; |
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).