64
GB
1 Important Information for Safe Use
1505093, Edition 2012-05, Version 5
1 1.5 Notes for the user
• All the work steps described in these Operating Instructions may only be carried out
by qualified personnel which have been authorised and instructed by the operator.
1.5.1 Instruction on the device
Instruction
• The instruction must be carried out immediately and directly on the
appliance
by
Ondal, by a company authorised by Ondal or by a person designated by the operator.
• On completion of the instruction, a certificate must be created and signed in order to
document that the user has understood the special operator control actions required
for normal use.
1.5.2 User's duty to inform and inspect
Duty to inform and inspect • Read these Operating Instructions carefully prior to initial use of the appliance. This
ensures that you benefit from all the advantages of the appliance and prevents any
risk of injury or damage to property.
• Prior to any use or transfer for use, the functional reliability and proper condition of the
appliance must be inspected by the user.
Special problems • In case of special problems which are not sufficiently described in detail in these
Operating Instructions, contact your supplier for your own safety.
1.5.3 Marking
CE mark: Ondal declares that the products comply with the relevant regulations set forth
in the applicable European Directives.
Recognised cUL component: This component has been recognised by Underwriters Lab-
oratories Inc. Representative samples of this product have been reviewed by UL and com-
ply with the applicable requirements.
1.5.4 Standards and guidelines
The appliance complies with the safety requirements of the following standards and direc-
tives:
• Medical Devices Act (Medizinproduktegesetz - MPG);
• MDD 93/42/EEC, 2007 – Medical Device Directive;
• EN 60601-1: 2006 - Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance.
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