Model 3231 USB Specifications
Oxygen Saturation Display Range: 0% to 100% SpO2
Pulse Rate Display Range: 18 to 321 beats per minute (BPM)
Declared Accuracy*: The table below shows Arms values measured using the Model 3231 in a clinical study.
Range | Specified Oxygen Saturation (Arms) | Finger Oxygen Saturation (Arms) | Thumb Oxygen Saturation (Arms) | Low Perfusion Oxygen Saturation (Arms) |
---|---|---|---|---|
70 – 100% | ±2 | ± 1.31 | ± 1.56 | ±2 |
70 – 80% | ±2 | ± 1.65 | ± 1.91 | ±2 |
80 – 90% | ±2 | ± 1.05 | ± 1.21 | ±2 |
90 – 100% | ±2 | ± 1.18 | ± 1.49 | ±2 |
This graph shows plots of the error (SpO2 – SaO2) by SaO2 using the 3231 with a linear regression fit and upper 95% and lower 95% limits of agreement. Each sample data point is identified by subject from a clinical study in non-motion conditions.
Pulse Rate Declared Accuracy Range (Arms)*: 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms)*: 40 to 240 BPM ±3 digits
Measurement Wavelengths and Output Power**:
Red. 660 nanometers @ 0.8 mW max. average
Infrared. 910 nanometers @ 1.2 mW max. average
Temperature:
Operating. -5 °C to 40 °C / 23 °F to 104 °F
Storage/Transportation. -40 °C to 70 °C / -40 °F to 158 °F
Device temperature will not exceed 41 °C as measured during a controlled
environment test.
Humidity:
Operating. 10% to 95% non-condensing
Storage/Transportation. 10% to 95% non-condensing
Altitude:
Operating. Up to 5,000 meters / 16,404 feet
Hyperbaric Pressure. Up to 4 atmospheres
Weight: < 72 g / 2.5 oz., including cable and connector
Classifications per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1/ UL 60601-1:
Degree of Protection: Type BF-Applied Part
Enclosure Degree of Ingress Protection: IP32
Mode of Operation: Continuous
* ±1 Arms represents approximately 68% of measurements.
** This information is especially useful for clinicians performing photodynamic therapy.
This product complies with ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing.
This device is not made with natural rubber latex.
This product complies with RoHS.
This product complies with REACH.