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Important Information for Safe Use
Duty to inform and inspect
1568913, Edition 2019-06, Version 0
1.5
•
All the steps described in these Operating Instructions may only be carried out by
qualified personnel who have been authorised and instructed by the operator.
1.5.1 Instruction on the appliance
Instruction
•
The instruction must be carried out on the appliance immediately by Nuvo, by a
company authorised by Nuvo 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
•
Read these Operating Instructions carefully prior to installation of the appliance.
This ensures that you benefit from all its advantages and prevents any risk of injury or
damage.
•
Prior to any use or transfer for use, the functional reliability and proper condition of the
appliance must be inspected by the user.
Troubleshooting
•
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: Nuvo declares that the products comply with the relevant regulations set forth in
the applicable European Directives.
CE mark with the ID number of the indicated conformity assessment body: Nuvo declares
that the assessment of conformity in accordance with 93/42 EEC (Medical Device Direc-
tive) has been performed by the indicated body.
This symbol marks the product as a component approved by a "Nationally Recognized
Testing Laboratory" which complies with both Canadian and US deviations from
applicable standards.
1.5.4 Standards and directives
The appliance complies with the safety requirements of the following standards, laws and
directives:
•
Medical Devices Act (MPG)
•
93/42 EEC (Medical Device Directive)
•
IEC 60601-1 – Medical Electrical Equipment – Part 1:
General Requirements for Basic Safety and Essential Performance
Notes for the user
12
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