Technical Information; Manufacturer's Declaration; Essential Performance; Table 2. Electromagnetic Immunity - Nonin 8500 Operator's Manual

Technical Information

NOTE: This product complies with ISO 10993-1, Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing.
CAUTION: A functional tester cannot be used to assess the accuracy of a pulse
!
oximeter monitor or sensor.
CAUTION: All parts and accessories connected to the serial port of this device must
!
be certified according to at least IEC Standard EN 60950, IEC 62368-1, or UL 1950
for data-processing equipment.
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.

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 8500 is defined as SpO
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.
Emissions Test
This device is intended for use in the electromagnetic environment specified below.
The user of this device should ensure that it is used in such an environment.
RF Emissions
22
Table 2: Electromagnetic Immunity
CISPR 11
accuracy and pulse rate accuracy or an
2
Compliance
Group 1, Class B
Technical Information