User's Manual
CONFIDENTIAL
CADI SmartSense – SmartNode SMN-822W User Manual
T-SMN-822-I02-A01
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7.2 IEC60601‐1‐2Compliance
7.2.1 BasicSafety
The basic safety is ensured, if it fulfils the safety requirements of the standard IEC 60601-1, especially the requirements against
electric shock, mechanical hazards and hazards out of over temperatures.
7.2.2 EssentialPerformance
The equipment has no direct clinical function or essential performance according to IEC60601-1.
7.2.3 IntendedUse
The device was developed to detect use of hand rub by sensing the pressure applied on the device. The device is operated
according to the instructions and information provided by the manufacturer.
Performance reduction is according to the following criteria allowed. This has to be considered in the risk analysis of the ME
Equipment or ME System.
Criteria A
The device withstands the test without damage or other disturbances, during and after the test the device works inside the
specified limitations correctly. The basic safety is ensured continuously.
Criteria B
The device withstands the test without damage or other disturbances, after the test the device works inside the specified limitations
correctly. The basic safety is ensured continuously.
Criteria C
A temporary malfunction is permitted, if the function itself restores or is recoverable by user intervention. The basic safety is
ensured continuously
7.2.4 IntendedEnvironment
Intended environments are the typical professional healthcare facility (Clinic, hospital) environment and Home healthcare
(medical practice and household) environment.
WARNING: RF Interference - Known RF sources, such as cell phones, radio or TV stations, and two-way radios, may cause
unexpected or adverse operation of this generator. Consult qualified personnel regarding system configuration.
WARNING: The generator should not be used adjacent to, or stacked with other equipment. If adjacent or stacked use is
necessary, test the generator to verify normal operation. Refer to the Electromagnetic Immunity information in Chapter 5.
7.2.5 Standard
IEC 60601-1-2:2014 4th Edition (EN 60601-1-2: 2015)