Overall Accuracy:
Accuracy (Arms) is expected to encompass approximately 68% of measured values and 95% Limits of Agreement are expected to encompass approximately 95% of measured values.
| Description | SaO2 Range | MetHb or COHb Range | Clinical Accuracy | Expected Accuracy/95% Limits of Agreement |
|---|---|---|---|---|
| %SpO2 accuracy with COHb | 70 – 100% | 0 – 3% COHb | ± 2 | (-2.6, 3.2) |
| %SpO2 accuracy with COHb | 80 – 100% | 0 – 15% COHb | ± 2 | (-2.3, 2.9) |
| %SpO2 accuracy with MetHb | 70 – 100% | 0 – 2% MetHb | ± 2 | (-2.3, 3.7) |
| %SpO2 accuracy with MetHb | 80 – 100% | 0 – 15% MetHb | ± 2 | (-3.0, 3.8) |
| %COHb accuracy with elevated HHb | 95 – 100% | 0 – 15% COHb | ± 3 | (-5.2, 4.3) |
| %COHb accuracy with elevated HHb | 80 – 100% | 0 – 15% COHb | ± 3 | (-5.5, 4.5) |
| %MetHb accuracy | 97 – 100% | 0 – 15% MetHb | ± 1 | (-1.5, 1.7) |
| %MetHb accuracy with elevated HHb | 80 – 100% | 0 – 15% MetHb | ± 1 | (-1.7, 2.1) |
Observed Clinical Study Accuracy
The tables below show Arms values measured using the Model 8330AA in a clinical study of healthy volunteer subjects.
%SpO2 Clinical Accuracy (Arms)1,2:
| SaO2 Range | COHb Range | Oxygen Saturation (Figure A) |
|---|---|---|
| 70 – 100% | 0 – 3% | ± 2 |
| 70 – 80% | 0 – 3% | ± 2 |
| 80 – 90% | 0 – 3% | ± 3 |
| 90 – 100% | 0 – 3% | ± 2 |
| SaO2 Range | COHb Range | Oxygen Saturation with COHb (Figure B) |
|---|---|---|
| 80 – 100% | 0 – 15% | ± 2 |
| 80 – 90% | 0 – 15% | ± 3 |
| 90 – 100% | 0 – 15% | ± 2 |
| SaO2 Range | MetHb Range | Oxygen Saturation (Figure C) |
|---|---|---|
| 70 – 100% | 0 – 2% | ± 2 |
| 70 – 80% | 0 – 2% | ± 2 |
| 80 – 90% | 0 – 2% | ± 2 |
| 90 – 100% | 0 – 2% | ± 2 |
| SaO2 Range | MetHb Range | Oxygen Saturation with MetHb (Figure D) |
|---|---|---|
| 80 – 100% | 0 – 15% | ± 2 |
| 80 – 90% | 0 – 15% | ± 3 |
| 90 – 100% | 0 – 15% | ± 2 |
%COHb Accuracy (Arms):
| SaO2 Range | COHb Range | %COHb Accuracy (Figure E) |
|---|---|---|
| 95 – 100% | 0 – 15% | ± 3 |
| 95 – 100% | 0 – 5% | ± 2 |
| 95 – 100% | 5 – 10% | ± 3 |
| 95 – 100% | 10 – 15% | ± 3 |
| SaO2 Range | COHb Range | %COHb Accuracy with Elevated HHb (Figure F) |
|---|---|---|
| 80 – 100% | 0 – 15% | ± 3 |
| 80 – 100% | 0 – 5% | ± 3 |
| 80 – 100% | 5 – 10% | ± 3 |
| 80 – 100% | 10 – 15% | ± 3 |
%MetHb Accuracy (Arms):
| SaO2 Range | MetHb Range | %MetHb Accuracy (Figure G) |
|---|---|---|
| 97 – 100% | 0 – 15% | ± 1 |
| 97 – 100% | 0 – 5% | ± 1 |
| 97 – 100% | 5 – 10% | ± 1 |
| 97 – 100% | 10 – 15% | ± 1 |
| SaO2 Range | MetHb Range | %MetHb Accuracy with Elevated HHb (Figure H) |
|---|---|---|
| 80 – 100% | 0 – 15% | ± 1 |
| 80 – 100% | 0 – 5% | ± 1 |
| 80 – 100% | 5 – 10% | ± 1 |
| 80 – 100% | 10 – 15% | ± 1 |
Pulse Rate Accuracy: 40 – 250 BPM ±3 digits (Arms):
Temperature:
Operating: -10 °C to 40 °C (14 to 104 °F)
Transient Operating: -20 °C to 50 °C (-4 to 122 °F)
Storage/Transportation: -40 °C to 70 °C (-40 to 158 °F)
Humidity:
Operating: 15% to 93% non-condensing
Transient Operating: 15% to 90% non-condensing
Storage/Transportation: Up to 93% non-condensing
Operating Altitude: 0 to 4,000 meters (0 to 13,123 feet)
Measurement Wavelengths and Output Power
Wavelength range: 600 to 910 nanometers
Output range: 1.5 to 18 mW
Compliance
This product complies with ISO 10993-1.
Not made with natural rubber latex.
Warranty
For warranty information refer to: https://www.nonin.com/warranty/
