(130 days)
The APO-8284 Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring.
Our device APO-8284 Fingertip Pulse Oximeter is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user.
It is a noninvasive measurement instrument with a pair of small light-emitting diodes (LEDs) facing a photodiode through a fingertip. One LED is red, with wavelength of 660 nm, and the other is infrared, 880 nm. The MCU calculates the ratio of these two wavelengths and get the results of the SPO2. At the same time, by examining only the varying part of the absorption spectrum, a monitor can ignore other tissues or nail, and discern only the absorption caused by arterial blood to detect the pulse rate.
More over, the APO-8284 also has the function of low battery voltage alarm and automatically power off. The power source is 2 × AAA batteries.
The device is for prescription. It is neither for life-supporting nor for implanting. lt does not contain any drug or biological product and it does not need to be sterile.
Here's a breakdown of the acceptance criteria and the study information for the APO-8284 Fingertip Pulse Oximeter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (APO-8284) |
|---|---|---|
| SpO2 Measuring Range | 70%-99% | 70%-99% |
| SpO2 Accuracy | 80-99%: ±2% | |
| 70-79%: ±3% | ±2% | |
| Pulse Rate Measuring Range | 30-235bpm | 30-250bpm |
| Pulse Rate Accuracy | ±2 bpm (30-99 bpm) | |
| ±2% (100-235 bpm) | ±2 bpm (30-99 bpm) | |
| ±2% (100-235 bpm) | ||
| Operation Temperature | 5°C-40°C | 5°C-40°C |
| Operation Humidity | 15%~80% |
§ 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).