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Manufacturer’s Declaration
Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2.
Essential Performance
Essential performance of the 9550 is defined as SpO
2
accuracy and pulse rate accuracy or an indication of abnormal operation.
Accuracies may be affected as a result of exposure to electromagnetic disturbances that are outside of the environments listed in the
Indications For Use. If issues are experienced, move the Nonin system away from the source of electromagnetic disturbances.
Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 4 years from the date of purchase, each Onyx II
9550 exclusive of the batteries, spring, carrying case, lanyard, and lanyard lock.
Nonin shall repair or replace any Onyx II 9550 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 II 9550 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 II 9550 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 II 9550, field service by non-Nonin personnel, tampering, or any kind of misuse of the Onyx II 9550, 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.
nonin.com
Military/Safe-to-Fly Information
Nonin Medical’s Onyx II 9550 has completed aeromedical test and evaluation by the U.S. Department of Army and has received a “Safe-
to-Fly” recommendation from the Department of the Air Force. The Onyx II 9550 carries a NATO Stock Number or National Stock
Number (NSN).
For additional information, contact regulatory@nonin.com.
WARNING: Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME system, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Table 1: Electromagnetic Emissions
This device is intended for use in the electromagnetic environment specified in the Indications for Use section. The user of this device
should ensure that it is used in such an environment.
Emissions Test Compliance
RF Emissions
CISPR 11
Group 1, Class B
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, USA
(800) 356-8874 (USA and Canada)
+1 (763) 553-9968 (outside USA and Canada)
Fax: +1 (763) 553-7807
E-mail: technicalservice@nonin.com
Nonin Medical B.V.
Prins Hendriklaan 26
1075 BD Amsterdam, Netherlands
+31 (0)13 - 79 99 040 (Europe)
Fax: +31 (0)13 - 79 99 042
E-mail: technicalserviceintl@nonin.com
7


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