Download Print this page

Testing Summary; Specifications; Warranty - Nonin Onyx 9500 Instructions For Use

Finger pulse oximeter

Advertisement

Replacing the Gripping Insert
A gripping insert is adhered to the upper inner surface of the Onyx
insert if it becomes torn or damaged, or if it begins to peel off. The Onyx
®
NONIN
gripping inserts.
1. Disengage the spring. (See instructions above.) It is unnecessary to completely remove the spring.
2. Carefully peel the old gripping insert away from the surface.
3. Remove any residual adhesive with a soft cloth dampened with isopropyl alcohol.
4. Peel the backing paper off the new gripping insert, uncovering the adhesive back.
5. Position the new insert (with the adhesive side toward the Onyx
6. Re-engage the spring. (See "Replacing the Spring.")

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
maintain 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
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 Arms represents approximately 68% of measurements.
**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
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
a warranty repair request on any Onyx
®
NONIN
personnel only. Any sign or evidence of opening the Onyx
®
Onyx
, shall void the warranty. All non-warranty work shall be done at NONIN
recommends using the insert during normal operation. Contact your local distributor for replacement springs and
®
*):
rms
rms
*):
rms
*):
rms
®
) warrants to the purchaser, for a period of two years from the date of purchase, each Onyx
®
has been notified by the purchaser by serial number that there is a defect, provided notification occurs within
®
found to be within specifications. Onyx
®
®
to provide a secure fit to the finger. Replace the gripping
®
will function without the gripping insert; however,
®
) and gently press it into place.
Medical, Incorporated as described below.
) of the sensors is compared to arterial hemoglobin oxygen (SaO
2
value) for all subjects, per ISO 9919:2005, Standard
rms
at the lowest obtainable pulse amplitude (0.3% modulation).
2
0% to 100% SpO
2
18 to 321 beats per minute (bpm)
70% to 100% SpO
±2 digits
2
*):
70-100% SpO
±2 digits
2
20-250 BPM ±3 digits
40-240 BPM ±3 digits
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 1,600 spot checks based on ~18 hours of operation using
two AAA-size alkaline batteries, calculated at 40 seconds per spot check.
9 months typical, using two AAA-size alkaline batteries
Type BF-Applied Part
IPX2
Continuous
®
shall repair or replace any Onyx
®
's place of business. NONIN
®
is a precision electronic instrument and must be repaired by trained
®
, field service by non-NONIN
personnel, tampering, or any kind of misuse of the
®
's standard rates and charges in effect at the time of delivery to NONIN
) value,
2
levels. The module must
2
®
found to be defective in accordance with this
®
delivered to the
®
reserves the right to charge a fee for
®
exclusive
®
.

Advertisement

loading