Standards; General Warnings; Service Life; Electromagnetic Compatibility Warnings - LEVITAS PIUMA UP Serie Manual De Instrucciones

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1. The devices satisfy the requirements of general safety and performance requested by
the Annex I of regulation 2017/745 as laid down by the Annex IV of the above mentioned
regulation.
2. The devices ARE NOT MEASURING INSTRUMENTS.
3. The devices ARE NOT MADE FOR CLINICAL TESTS.
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-
1:2005+A1:2012
EN 60601-1-2:2007
IEC 60601-1-11:2010
IEC 60601-1-6:2010+A1:2013
IEC 62366:2007+A1:2014
EN ISO 13485:2012+AC:2012
EN ISO 14971:2012
EN ISO 15223-1:2012
EN 1041:2008
EN 71-3:2013+A1:2014

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
60601-1-2:2007. 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: