Any possible modi cation and/or alteration to this device is prohibited, without prior
authorization thereto by the Manufacturer.
In the event that the R27A/R37A is connected up to other devices having individual, external
power supply sources, it is necessary to test compliance of the overall system to the EN 60601-
1-1 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.
During test performance, always check the unit’s stimulus frequency intensity setting
prior to conveyance to the patient. 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 R27A/R37A device is not suitable for use with ammable
anesthetics. The R27A/R37A 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.
33
Safety warnings and precautions
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