21
Manufacturer’s guide and declaration – electromagnetic emissions
INN-011 is intended to be used in the electromagnetic environment specified below. The
patient or use of INN-011 should assure it’s used in this environment.
Emission test
Compliance
Electromagnetic environment
Emissions at RF CISPR 11
Group1
INN-011 uses radiofrequency
energy only for its internal functio-
ning. As a result, its RF emissions
are very low and are unlikely to
cause any interference in nearby
electronic devices.
Emissions at RF CISPR 11
Class B
INN-011 is suitable for use in all
domestic markets and connected
directly to the public power
voltage grid.
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emis-
sions IEC 61000-3-3
Compliant
The product is designed to work with a rating up to an altitude of 3000 m. The electro-
medical device requires special precautions regarding EMC (Electromagnetic Compatibi-
lity) and must be installed and put into service in accordance with the EMC information
contained in the accompanying documents.
Portable and mobile radiocommunication equipment can affect the operation of the
EUT (Equipment under test).
The use of accessories, transducers and cables other than those specified, with the
exception of those sold by the manufacturer as spare parts for internal components,
may cause an increase in emissions and a decrease in immunity.
The appliance or system must not be used near other appliances and, if it is necessary
to use it near other appliances, the electro-medical device must be observed to check
normal functioning in the configuration in which it is used.
The electro-medical device has been tested and found to comply with the emission and
immunity limits of electromedical equipment according to IEC60601-1-2: 2014. These
limits are designed to provide adequate protection against harmful interference in a
typical medical installation. However, there is no guarantee that interference will not
occur in a particular installation.
If the electro-medical device, interacting with another device, causes or receives detec-
table interference, the user is invited to limit interference by adopting one or more of
the following measures:
1. reorient or relocate the receiving device;
2. increase the distance between the appliances;
3. connect the equipment to an outlet on a circuit different from the device (s) causing
the interference;
4. contact the manufacturer or local technician for assistance