ED01_REV02-2021 IFU CTS-EN
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PRODUCED BY
:
OSCAR BOSCAROL SRL
Via Enzo Ferrari 29
39100 Bolzano
ITALY
Tel. +39 0471 932893
Fax: +39 02 57760140
Information on the manufacturer and the medical device:
•
Oscar Boscarol applies a quality management system in accordance with international standards
ISO 13485 and ISO 9001.
•
Medical devices in the "Immobilization" category (in all their configurations) comply with European
Regulation MDR 2017/745 and bear the CE marking in accordance with risk class I (see Annex VIII of
the Regulation).
•
The medical device meets the safety and performance requirements (GSPR) described in Annex I of
European Regulation 2017/745
Information on these operating instructions:
•
This document contains important information for the safe, effective and compliant use of the
medical device.
•
Use the information reported to train users and confirm their training
•
This manual may not be modified (even partially). Only the manufacturer of the device may make
changes
•
These instructions should always accompany the device. We recommend using the electronic
version and making it available on operators' PDAs, tablets and mobile phones.
These operating instructions apply to the following devices:
IMM120050
