(223 days)
The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a singlepatient device and can be used in any setting - home, factory, pharmacy, hospital or physician's office.
Spirotel is a pocket spirometer that can also feature a pulse oximeter function (optional). It measures a range of functional respiratory parameters, and the oxygen saturation and pulse rate. The device can operate completely autonomously or can be connected to a personal computer by means of various types of connections: USB, Bluetooth, GSM.
Here's a breakdown of the acceptance criteria and the study information for the Spirotel device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Spirometry Function | ||
| Volume Accuracy | ± 3% or 50 mL (ATS Standards) | Within the range of accuracy required by ATS (American Thoracic Society Standards) |
| Flow Rate Accuracy | ± 5% or 200 mL/s (ATS Standards) | Within the range of accuracy required by ATS (American Thoracic Society Standards) |
| Dynamic Resistance at 12 L/s |
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).