(391 days)
The EC50 ToxCO+ Breath Carbon Monoxide Monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.
The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a handheld device, which provides a non-invasive means of determining Carbon Monoxide (CO) poisoning and Carboxyhaemoglobin (COHb) when blood testing is not available. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is also ideal for use during triage to ensure suspected cases of CO poisoning are not missed. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a microprocessor-controlled device powered by 2 AA batteries with an Alphanumerice LCD display housed in a sturdy ABS case with a synthetic rubber boot. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is designed to have an operating temperature between 0-30° C, operating humidity 10-95% non-condensing and has storage temperature requirements of 0-30° C. The sensor sensitivity is 1 pmm, has a warm up time of
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: EC50 ToxCO+ Breath Carbon Monoxide Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not explicitly define a formal "acceptance criteria" table with specific thresholds that the device must meet to be deemed acceptable. Instead, it relies on comparison to predicate devices and reported specifications.
| Acceptance Criteria (Implied) | Reported Device Performance (EC50 ToxCO+) |
|---|---|
| Accuracy: Comparable to predicate devices | ±5% of reading |
| Concentration Range: Comparable to predicate devices | 0-50% COHb/0-500ppm CO |
| Sensor Sensitivity: Comparable to predicate devices | 1 ppm |
| Warm-up Time: Comparable to predicate devices |
§ 868.1430 Carbon monoxide gas analyzer.
(a)
Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.(b)
Classification. Class II (performance standards).