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D-0116493-B (OM015)
– PC850 Operating Manual
Amplivox Ltd. will make available on request circuit diagrams, component part lists, descriptions, calibrations
instructions, or other information that will assist authorized service personnel to repair those parts of this
instrument that are designated by Amplivox Ltd. as repairable by service personnel.
No parts of the equipment can be serviced or maintained while in use with the patient.
Connect only accessories purchased from Amplivox Ltd. to the PC850. Only accessories which have been
stated by Amplivox Ltd. to be compatible are allowed to be connected to the device or cradle.
To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2 for electromagnetic compatibility
(EMC) the audiometer is designed to be used only with the medically-approved mains adapter supplied, which
is specified as part of the equipment.
Do not use any other type of mains adapter with this instrument.
The output from the mains adapter is fitted with electronic circuit protection. In case of overload the adapter
will shut down and the indicator will be extinguished. When the fault is cleared the adapter will operate as
normal.
The input to the mains adapter is protected with a non-replaceable fuse. If this fails the adapter will not operate.
The mains adapter is the mains disconnect device and therefore the audiometer should be positioned such
that easy access to the mains adapter is possible.
3.3.3.
ENVIRONMENTAL FACTORS
Use and store the instrument indoors only. It is recommended that the instrument
be operated within an ambient temperature range of 15 °C / 59 °F to 35 °C / 95 °F
and in relative humidity between 30 % and 90 % (non-condensing).
Do not use the device in the presence of fluid that can come into contact with any of the electronic components
or wiring. Should the user suspect fluids have contacted the system components or accessories, the unit
should not be used until deemed safe by an authorized service technician.
3.3.4.
ELECTRICAL AND ELECTROSTATIC SAFETY
Before performing any service to the insert earphones you must uncouple the
PC850 transducers from the patient.
Do not touch the contacts on the back of the instrument and the patient at the
same time. The consequence could be a too high leakage current to the patient.
Do not open the case of the instrument. Refer servicing to qualified personnel.
This equipment is intended to be connected to other equipment thus forming a Medical Electrical System.
External equipment intended for connection to signal input, signal output or other connectors must comply with
the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical
electrical equipment. In addition, all such combinations
– Medical Electrical Systems – must comply with the
safety requirements stated in the general standard IEC 60601-1, (edition 3.1), clause 16. Any equipment not
complying with the leakage current requirements in IEC 60601-1 must be kept outside the patient environment
i.e. at least 1.5m from the patient support or must be supplied via a separation transformer to reduce the
leakage currents. Any person who connects external equipment to signal input, signal output or other
CAUTION
WARNING
CAUTION
