General Notes; Service, Repairs, Maintenance - Physiomed vocaSTIM-Master Operating Instructions Manual

General Notes

11 General Notes
The instrument may only be operated in dry rooms designed for medical purposes,
in accordance with VDE 0107, User Class 1. These include rooms with patient beds,
physical therapy rooms and practice rooms.
It complies with the technical specifications of IEC 601, VDE 0750 and is assigned to
class IIa according to the
It is not intended for operation in explosion hazard zones or hydrotherapy rooms.
Drastic temperature changes should be avoided, since condensation could be
caused within the instrument. Do not start up the instrument until it is in
temperature equilibrium with its environment!
The instrument is to be operated properly, i.e. in accordance with the
Instructions
.
During operation, electromagnetic waves are emitted by the instrument. Please
consider this exposure in its environment and care for sufficient distance to other
electronic devices. Please also take into account that that the electromagnetic waves
of other devices might also interfere with the instrument and take care that these
devices have sufficient distance to the unit.
Never connect the patient to a high-frequency surgical instrument simultaneously,
since burns under the electrodes could be caused. Operating the instrument in the
vicinity (e.g. 1 m) of a short-wave or micro-wave therapy unit may cause output
irregularities and should be avoided for this reason.

12 Service, Repairs, Maintenance

The manufacturer is only obliged to guarantee the safety features of the instrument
in its original state.
The instrument must be operated in accordance with the
Repairs to the instrument may only be performed by parties duly authorised by
PHYSIOMED ELEKTROMEDIZIN AG
must be accompanied by written certification, describing the nature and extent of
the repairs undertaken, as applicable with details regarding changes to nominal
operating values or the operational range. The certification must also contain the
date performed, the name of the repair company and the signature of the
repairman.
When defective, components affecting the safe operation of the instrument must be
replaced by manufacturer's original parts.
Upon request, wiring diagrams, parts lists and service instructions can be made
available to qualified technical personnel employed by the customer.
We recommend having the instrument, including all accessories, serviced at regular
intervals. Please refer to the
safety regulations control.
42
Council Directive concerning Medical Devices
. Any repairs performed by an authorised agent
Manufacturer's Recommendations
.
Operating
Operating Instructions
(page 47) for the
vocaSTIM -Master
®
.