17
Portable and mobile radio frequency communication devices can affect medical elec-
trical equipment. The ME device is for operation in an electromagnetic environment
for home health care and intended for professional facilities such as industrial areas
and hospitals.
The user of the device should ensure that it is operated within such an environment.
Warning:
The ME device may not be stacked, arranged or used directly next to or with other de-
vices. When operation is required to be close to or stacked with other devices, the ME
device and the other ME devices must be observed in order to ensure proper operation
within this arrangement. This ME device is intended for use by medical professionals
only. This device may cause radio interference or interfere with the operation of nearby
devices. It may become necessary to take appropriate corrective measures, such as
redirecting or rearranging the ME device or shield.
The rated ME device does not exhibit any basic performance features in the sense of
EN60601-1, which would present an unacceptable risk to patients, operators or third
parties should the power supply fail or malfunction.
Warning:
Portable RF communications equipment (radios), including their accessories, such
as antenna cables and external antennas, should not be used less than 30 cm (12
inches) away from the ri-mini® and pen-scope® instrument head parts and cables
specified by the manufacturer. Failure to comply may result in a reduction in the de-
vice‘s performance features.
10
Guidance and manufacturer's declaration - electromagnetic emission
The ri-mini® and pen-scope® instruments are intended for use in the electromagnetic environment specified
below. The customer or user of the ri-mini® and pen-scope® should ensure that it is used in such an
environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions
HF- emissions pursuant to
CISPR 11
Group 1
The ri-mini® and pen-scope® use RF energy
exclusively for internal functions. Therefore, its RF
emissions are very low and unlikely to disturb
nearby electronic devices.
RF emissions
HF- emissions pursuant to
CISPR 11
Class B
The ri-mini® and pen-scope® are intended for use
in all establishments, including residential areas
and those directly connected to a public supply
network that also supplies buildings used for
residential purposes.
Emissions of harmonics
IEC 61000-3-2
Not applicable
Emissions of voltage
fluctuations, flicker
IEC 61000-3-3
Not applicable
