(79 days)
The BCI 3404 Monitor is a portable ECG and oximetry monitor with optional impedance respiration. It continuously and non-invasively monitors and displays functional oxygen saturation of arterial hemoglobin(SpO2), pulse rate, respiration rate, plethysmogram and ECG waveforms. Alarms are available for ECG and oximetry. There are no respiration rate alarms. The 3404 may be used in the hospital or clinical environment, and during emergency land transport.
The device will provide fast, reliable measurements on patients ranging from pediatric to adult when using the appropriate BCI accessories.
The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. The monitor is not intended for neonatal use.
The BCI 3404 Oximeter / ECG Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys ( on/off, waveform / trend, alarm silence, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs.
Here's a breakdown of the acceptance criteria and study details for the BCI 3404 Oximeter / ECG Monitor, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (Mean Error ± SD) |
|---|---|---|
| Bench Tests | ||
| ECG Rates (beats per minute) | ±2 bpm or ±2% (greater of) | 0 bpm ± 0 bpm |
| Oximetry % SpO2 | ±2% SpO2 (min) | 0.25% ± 0.45% |
| Oximetry Pulse Rate (bpm) | ±2 bpm or ±2% (greater of) | 1.18 bpm ± 0.90 bpm |
| Respiration (breaths per minute) | ±1 bpm or ±5% (greater of) | 0 bpm ± 0 bpm |
| Clinical Tests (Oximetry) | ||
| SpO2 (70% - 100%) | Standard Deviation ≤ 2.0% | 1.8% (Standard Deviation) |
| SpO2 (50% - |
§ 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).