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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
1.7.4 Safety standards, norms
All MediTouch systems are produced according to strict safety and quality controls. The product
must not be used, if the certificates/permissions and the (according to the list of technical
specifications) defined safety standards do not correspond with the local and country-specific
requirements. The country-specific requirements must be compared before initial operation. Operate
BalanceTutor system only, if the requirements correspond. Full list of applicable norms see also in
the CE-certificate of compliance.
The standards with date in this manual with reference to design and construction characteristics refer
to the up to date valid versions at the time of manufacture.
The standards with date in this manual applying to routine measurements and continual safety
relevant measures (e.g. electrical measurements to determine leakage current, insulation resistances
etc.) can and will change with time. Therefore the up to date valid versions of the respective
standards at the time of measurement and their limit values, which can deviate then from the
procedures and limit values in this manual, apply.
1.7.5 The CE mark
The
mark on the nameplate of the device confirms the compliance to the council directive
89/336/EEC appendix I (EMC electromagnetic compatibility).
1.7.6 EMC Electromagnetic & Safety Compatibility
The BalanceTutor system for medical applications has been built corresponding to the European
Union Council Directive 93/42/EEC Norms: EMC: EN60601-1-2, Safety: EN60601-1 Ed 3.1
Certification bodies: ITL
–
Israel Testing Laboratories.
