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www.meditouch.co.il
info@meditouch.co.il
Tel: (972)-9-8637477
Fax: (972)-9-8852935
45 Hamelacha, Poleg industrial zone, Netanya, Israel.
Zip: 42505, PO Box: 8306
DO-15-01-02
BalanceTutor user manual 200824.doc
The BalanceTutor system may only be used if maintenance has been carried out properly
according to the instructions included in this user manual.
Consulting, sales, installation, commissioning, instruction, inspections, maintenance and
service repair works only through trained and by MediTouch certified personnel.
1.1 Electric safety / safety classes
The BalanceTutor is a class Ⅰ ME equiepment (Medical Electrical)
. Therefore,
Background:
In order to protect the user and the personnel, the association of German electro technicians Inc, (VDE) has published
special directives for medical used rooms and electro-medical devices. Devices with a power supply therefore have to, in
order to prevent the passing on of the mains voltage over to touchable metal pieces, be equipped with not only a reliable
isolation of the parts being under voltage but also additional safety precautions.
The VDE-association divides it into so called safety classes. For electro-medical devices, licensed safety classes are
mainly used the safety class I (i.e. safety precautions with protective wiring), and the safety class II, (i.e. safety measures
without protective wiring but with double isolation): Devices of the safety class I are devices, where the metallic casing-
parts are connected with the protective wire of the line net via the safety contact. In the case of an isolation error the
inserted fuse element switches off.
1.2 Patient and Therapist security according to IEC 601-1
At your BalanceTutor medical product the user is protected / isolated from the mains in accordance
with the safety standard referring to the requirements for leakage current values according to IEC
601-1. The connection of further mains-operated units to your BalanceTutor may cause that all the
leakage currents add and the safety of the patient is reduced. Due to this the connection of further
units may only be carried out on consultation with MediTouch.
1.3 Connection of units installed outside medically utilized locations
If units installed outside medically utilized locations (e.g. external printer, host computer etc.) are
connected to a MediTouch unit installed in a medically utilized location the VDE 0750 regulations
must be observed. Connection only via:
1.
Optical fiber or optocoupler (4
kV checked and approved) or …
2.
Protective isolation via insulation transformer according to IEC 601-1.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
