Testing Summary
SpO
2
accuracy and low perfusion testing was conducted by NONIN
®
Medical, Incorporated as described below.
SpO
2
Accuracy Testing
SpO
2
accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects in an independent research
laboratory. The measured arterial hemoglobin saturation value (SpO
2
) of the sensors is compared to arterial hemoglobin oxygen (SaO
2
) value,
determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors is in comparison to the co-oximeter samples measured over
the SpO
2
range of 70-100%. Accuracy data is calculated using the root-mean-squared (A
rms
value) for all subjects, per ISO 9919:2005, Standard
Specification for Pulse Oximeters for Accuracy.
Low Perfusion Testing
This test uses an SpO
2
Simulator to provide a simulated pulse rate, with adjustable amplitude settings of various SpO
2
levels. The module must maintain
accuracy in accordance with ISO 9919:2005 for pulse rate and SpO
2
at the lowest obtainable pulse amplitude (0.3% modulation).
Specifications
Oxygen Saturation Display Range:
0% to 100% SpO
2
Pulse Rate Display Range:
18 to 321 beats per minute (bpm)
Oxygen Saturation Declared Accuracy Range: (A
rms
*):
70% to 100% SpO
2
±2 digits
Low Perfusion Oxygen Saturation Declared Accuracy Range
(A
rms
*):
70-100% SpO
2
±2 digits
Pulse Rate Declared Accuracy Range (A
rms
*):
20-250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (A
rms
*):
40-240 ±3 digits
Measurement Wavelengths and Output Power**:
Red:
Infrared:
660 nanometers @ 0.8 mw maximum average
910 nanometers @ 1.2 mw maximum average
Temperature (Operating):
+32° to +104°F / 0° to +40°C
Temperature (Storage/Transportation):
-22° to +122°F / -30° to +50°C
Humidity (Operating):
10% to 90% non-condensing
Humidity (Storage/Transportation):
10% to 95% non-condensing
Altitude (Operating):
Up to 40,000 feet / 12,192 meters
(Hyperbaric Pressure):
Up to 4 atmospheres
Battery Life (Continuous):
Approximately 2,500 spot checks based on ~21 hours of operation using two
AAA-size alkaline batteries, calculated at 30 seconds per spot check.
Battery Life (Storage):
4 years, minimum
Classifications per IEC 60601-1 / CSA 601.1/ UL 60601-1:
Degree of Protection:
Type BF-Applied Part
Enclosure Degree of Ingress Protection:
IPX2
Mode of Operation:
Continuous
This product complies with ISO 10993-1.
*± 1 A
rms
represents approximately 68% of measurements.
**This information is especially useful for clinicians performing photodynamic therapy.
Warranty
NONIN
®
MEDICAL, INCORPORATED, (NONIN
®
) warrants to the purchaser, for a period of two years from the date of purchase, each Onyx
®
exclusive
of the batteries, spring, carrying case, lanyard, and lanyard lock. NONIN
®
shall repair or replace any Onyx
®
found to be defective in accordance with this
warranty, free of charge, for which NONIN
®
has been notified by the purchaser by serial number that there is a defect, provided notification occurs within
the applicable warranty period. This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any Onyx
®
delivered to the purchaser
which is found to be defective in any manner whether such remedies be in contract, tort or by law. This warranty excludes cost of delivery to and from
NONIN
®
. All repaired units shall be received by the purchaser at NONIN
®
’s place of business. NONIN
®
reserves the right to charge a fee for a warranty
repair request on any Onyx
®
found to be within specifications. Onyx
®
is a precision electronic instrument and must be repaired by trained NONIN
®
personnel only. Any sign or evidence of opening the Onyx
®
, field service by non-NONIN
®
personnel, tampering, or any kind of misuse of the Onyx
®
, shall
void the warranty. All non-warranty work shall be done at NONIN
®
’s standard rates and charges in effect at the time of delivery to NONIN
®
.
