Codes; Introduction; Intended Use; Eu Declaration Of Conformity - Moretti Levitas ST625 Serie Manual Del Usuario

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5 April 2017 on medical devices

1. CODES

ST625/x Mattress in polyurethane foam with a truncated pyramid-shaped surface
Mattresses certified in fire reaction class 1 IM
ST725/x Mattress in fire-retardant polyurethane foam with a truncated pyramid-shaped surface
ST728/x Mattress in fire-retardant composite polyurethane foam with a textured surface
ST729/x Mattress in fire-retardant composite polyurethane foam with an ovoid-shaped surface
ST732/x Mattress in fire-retardant composite polyurethane foam with a truncated pyramid-
shaped surface

2. INTRODUCTION

Thank you for choosing an anti-decubitus device in the LEVITAS range by Moretti. Moretti anti-
decubitus devices have been designed and manufactured to satisfy all your needs for practical,
correct and safe use. This manual contains useful suggestions for using your device properly
and safely. Please read this entire manual carefully before you use the mattress. Should you
have any queries, please contact your dealer for suitable advice and assistance.
NOTE, CAUTION AND WARNING
NOTE: indicate several recommendations.
CAUTION: indicate the correct operating or maintenance procedures, in order to avoid damage
to the device, the equipment or other items.
WARNING: draw attention to a potential hazard that requires correct procedures or practices
to avoid injury.

3. INTENDED USE

The LEVITAS anti-decubitus mattresses by Moretti are intended to prevent the bedsores that
can occur in any situation requiring lengthy hospitalisation and/or being laid up at home.
WARNING!
• Do not use the product for any purpose other than that specified in this manual
• The device must be installed by personnel qualified to perform general nursing
procedures and who have received appropriate training in the prevention and
treatment of bedsores
• Moretti S.p.A. declines any and all liability for damages resulting from improper
use of the device or any use other than that specified in this manual
• The manufacturer reserves the right to modify the device and this manual
without prior notice, in order to improve its features

4. EU DECLARATION OF CONFORMITY

MORETTI SpA declares, under its own exclusive responsibility, that the products made and
sold by MORETTI SpA in the POLYURETHANE MATTRESSES product family conform with the
applicable provisions of Regulation (EU) 2017/745 of 5 April 2017 on MEDICAL DEVICES.
Class I medical device
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