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