Electromagnetic Interferences And Electrostatic Discharges; Materiovigilance; Life-End; Product Description - Delmont imaging iCare Guide D'utilisation

It meets the requirements of European Directive 93/42/EEC on medical devices. It therefore complies with the
relevant electrical safety (IEC) and electromagnetic compatibility (EMC) standards.
3.2.

Electromagnetic interferences and electrostatic discharges

Although this product complies with EMC standards, it is possible that under very special circumstances it may
cause interference to other devices, or may itself be affected by other devices or an adverse electromagnetic
environment.
To avoid these situations, it is recommended:
- to ensure the quality of the electrical network (especially the grounding of all equipment and trolleys),
- to keep the device away from electromagnetic sources (for example, a compressor, a motor, a transfor-
mer, an HF generator, etc.).
3.3.

Materiovigilance

As any medical device, this device is subject to the provisions of the materiovigilance. Any serious malfunction
must therefore be reported to the competent authorities and the manufacturer as soon as possible and with the
greatest possible precision.
Manufacturer's contact information: refer to the last page of this IFU.
3.4.

Life-end

This device carries the recycling symbol in accordance with the European Directive 2002/96/EC on the Waste of
Electrical and Electronic Equipment (WEEE).
Proper disposal of this device will help prevent any harmful consequences for the environment and human health.
The symbol on the unit or accompanying documentation indicates that this product may under no circums-
tances be treated as household waste. It must therefore be handed over to a waste collection centrer responsible
for recycling electrical and electronic equipment.
For disposal, observe the waste disposal regulations in force in the country of installation.
For further details on the processing, recovery and recycling of this unit, please contact your nearest commercial
representative for instructions.

4. Product description

4.1.

Control unit description

[7]
[1] : The fans on the rear of the unit must not be blocked to prevent overheating. The light source is equipped with
an automatic safety feature that stops the lighting if the internal temperature becomes excessive.
Fans on the left side and under the unit are also present for better ventilation.
D900 700 053 B
Instructions for use: iCare imaging station
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Rev 09/2018
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