Passport 12/Passport 8 Operator’s Manual B-1
B EMC and Radio Regulatory Compliance
B.1 EMC
The device meets the requirements of IEC 60601-1-2.
Note
Using accessories, transducers and cables other than those specified may result in increased
electromagnetic emission or decreased electromagnetic immunity of the patient monitoring equipment.
The device or its components should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the device or its components should be observed to verify normal operation in the
configuration in which it will be used.
The device needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided below.
Other devices may interfere with this monitor even though they meet the requirements of CISPR.
When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous
measurements could result.
Portable and mobile communication equipment may affect the performance of this monitor.
Guidance and Declaration - Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device
should assure that it is used in such an environment.
Emission tests Compliance Electromagnetic environment - guidance
Radio frequency (RF) emissions
CISPR 11
Group 1 The device uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions CISPR 11 Class A The device is suitable for use in all establishments other than
domestic and those directly connected to the public
low-voltage power supply network that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC61000-3-2
Class A
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
Complies
WARNING
This equipment/system is intended for use by healthcare professionals only. This equipment/ system may
cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM] or shielding the
location.