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4. The devices are packed in NON-STERILE BOX.
5. The devices belong to class I in accordance with the provisions of Annex VIII of the above
mentioned regulation
6. Moretti S.p.A. provides to the Competent Authorities the technical documentation to
prove the conformity to the 2017/745 regulation, for at least 10 years from the last lot
production.
Note:
Complete product codes, the manufacturer registration code (SRN), the UDI-DI code and
any references to used regulations are included in the EU declaration of conformity that Moretti
S.p.A. releases and makes available through its channels.
5. STANDARDS
The system has been tested and successfully approved to the following standards:
EN 60601-1
EN 60601-1-2
EN 55011 Classe B
EN 61000-3-2 Classe A
EN 61000-3-3
6. GENERAL WARNINGS
• For proper use of the device, refer to the following manual carefully
• Advise with physician or therapist to determinate the correct adjustment and the correct
use of the device
• Keep the packed kit away from heat sources
• SERVICE LIFE- the device use limit is defined by the wear of the parts
• DO NOT allow children to play on or operate the pump
• The user and/or the patient will have to report any serious accident that have occurred
related the device to the manufacturer and appropriate authority of the State which the
user and/or patient belongs to.
6.1 Electromagnetic compatibility warnings
This equipment has been tested and it complies with medical devices limits belonging
to EN 60601-1-2. These limits have been designed to provide reasonable protection
against harmful interference in a typical medical installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance
with the instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guaranteed that the interference will not occur in a particular
installation. If this equipment does cause harmful interference to other devices, which
can be determined by turning the equipment off and on, the user is encouraged to
try to correct the interference following one or more of the suggestions below:
• Reorient or relocate the receiving device
• Increase the separation between the equipment
• Connect the equipment into an outlet on a circuit different from that to which the other
devices are connected
• Consult the manufacturer or field service technician for help
7. SYMBOLS
Product code
Unique Device Identification
Summary of Contents for LAD680
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