Any possible modi cation and/or alteration to this device is prohibited, without prior
authorization thereto by the Manufacturer.
In the event that the R25C/R35C is connected to other devices having individual, external
power supply source, it is necessary to test, under the technician’s responsibility, the compliance
of the overall system to the EN 60601-1 Standard Provisions. Should the implementation of
any insulation or grounding devices be required to meet conformity, said devices must also
conform to Standard EN 60601-1.
When using the middle ear analyzer probe, ensure that suitably-sized tips are used and check
that they are perfectly ear-sealed and do not cause the patient any discomfort. Said tips are to
be selected from the set of ear tips on supply with the device. Use of a new tip for each patient
is compulsory.
During test performance, always check the unit’s stimulus frequency intensity setting prior to
starting testing. This is to ensure application of acceptable patient stimulation intensity levels.
Prior to starting a new patient, proceed with cleaning the sections of the transducers that
come into direct contact with the patient (e.g. earphone pads). All cleaning operations need to
be performed using an appropriate antiseptic solution, compliant to the instructions provided
directly by the antiseptic product Manufacturer. Please also consult the maintenance and
cleaning section in this manual. The R25C/R35C device is not suitable for use with ammable
anesthetics. The R25C/R35C is furthermore not provided with protection against the ingress of
liquids: the possible penetration of drops and/or liquid spray substances may result in serious
damages occurring to the unit.
The unit must always be used with the unit’s own transducers, provided on-supply by the
Manufacturer. Please be advised that the unit has been calibrated for use with the transducers
that are supplied. If they are replaced, recalibration of the unit is necessary. In the event that the
transducers are connected to the device through extension cables, as is required in the event
of connections to soundproof cabins, it is recommended to proceed with unit recalibration.
Although the unit is compliant to the EMC (electromagnetic compatibility) regulations
currently in force, prevention of unit exposure to other electromagnetic sources such as cell
phones is highly recommended. Should the unit be in the vicinity of or placed alongside other
devices, prior to using the unit please ensure that there are no interferences between the two
systems.
39
Safety warnings and precautions
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