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510(k) Data Aggregation
(85 days)
3304 PULSE OXIMETER
The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104° F (0 to 40° C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals
The new BCI 3304 pulse oximeter is an updated version of existing pulse oximeters legally marketed by BCI International. This updated device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence, Alarm Volume, Pulse Volume). The oximeter has a printer / pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location.
This document describes the BCI 3304 Pulse Oximeter, an updated version of existing pulse oximeters.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for pulse oximeters typically relate to the accuracy of SpO2 measurements compared to a reference standard, often expressed as a standard deviation (SD) within specific saturation ranges. While specific predefined acceptance criteria (e.g., "SD must be
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