Background and Identification
The BCI 3303 is a hand-held pulse oximeter made by BCI International, Inc., a healthcare product company. Pulse oximeters are non-invasive devices used to monitor a patient’s oxygen saturation. This model is designed for in-home use, hospital or clinical use, and emergency transport use. It features Clinician, Home-Use, and Sleep Study modes specialized for each application.
The 3303 model includes a mainboard, a display board, a key label, and a battery. The oximeter’s main board includes the device’s battery charger, power supplies, microprocessor, data acquisition circuitry, and on/off control logic. The display board includes an LED bar graph, indicator lights, an LED driver chip, the 7-segment displays, and the speaker circuitry. The mainboard and display board are connected via an eight-conductor cable. The oximeter’s key label includes two LED lights and the front panel touch keys.
The 3303 model pulse oximeter can produce audible patient alarms and system alerts. Users can adjust the alarm limits for the pulse rate and saturated oxygen level. The system includes an internal rechargeable NiMH battery. The patient’s saturated oxygen level, pulse rate, and pulse strength are shown on the device’s LED display.
The 3303 pulse oximeter features a light blue protective rubber boot and can be sold with an optional pole mount.
Technical Specifications
Physical Weight & Dimensions:
- Height: 7.25 inches (18.4 cm)
- Width: 3.3 inches (8.4 cm)
- Depth: 1.85 inches (4.7 cm)
- Weight: 19 oz. (539 grams)
Power:
- AC Power: 105-125V ~ 60Hz
- Optional: 207-253V ~ 50Hz, 90-110V ~ 50Hz
- Battery Standard: NiMH (Nickel Metal Hydride)
- Battery Life: Internal rechargeable, not user-replaceable. Fully charges in about 6 hours. Approximately 24 hours of continuous use.
Environment:
- Operating Temperature: -4°F to 131°F (-20°C to 55°C)
- Storage Temperature: -40°F to 167°F (-40°C to 75°C)
- Relative Humidity (non-condensing): 10-95% (storage); 15-95% (operating)
Displays, Indicators & Keys:
- SpO2: LED numeric display 0.43 inches (11 mm) high
- Pulse Rate: LED numeric display 0.375 inch (9.5 mm) high
- Pulse Strength: Logarithmically scaled 8-segment LED bar graph
- Low Battery: LED flashes when approximately 30 minutes of battery life remains
- Alarm Silence: LED flashes or lights to remind the user that audio alarms are disabled
- Sensor: LED flashes to alert the operator to check the SpO2 sensor placement
SpO2:
- Range: 0-100%
- Accuracy: ±2% at 70-100%; ±3% at 50-69%
- Averaging: 4, 8, or 16 pulse beat average
- Alarm Range: High - 50%-100% & OFF (1% steps) Low - OFF & 50%-99% (1% steps)
Pulse Rate:
- Range: 30-254 bpm
- Accuracy: ±2% at 30-254 bpm
- Resolution: 1 bpm
- Alarm Range: High - 5-250 bpm & OFF (5 bpm steps) Low - OFF & 5-250 bpm (5 bpm steps)
Memory:
Spot checks and trends can be stored for up to 99 patients and 24 hours of run time.
Auxiliary Serial Printer/Computer Output:
Data saved every thirty seconds can be printed or downloaded to a PC (trend). Data saved every four seconds in sleep mode can be output and processed by commercially available sleep study software.
Mechanical Durability Test Results:
- Vibration Testing: In compliance with IEC 68-2-6, IEC 68-2-34
- Shock Testing: In compliance with IEC 68-2-27
- Drop Testing: Exceeded UL 544 testing recommendations
- Standards: EN60601-1, EN60601-1-2, CSA Std. C22.2 No. 125, UL 544
- Regulatory Compliance: 510(k): K945754; ISO 9001/ISO 13485