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ED01_REV02-2021 IFU CTS-EN
:
PRODUCED BY
OSCAR BOSCAROL SRL
Via Enzo Ferrari 29
39100 Bolzano
ITALY
Tel.
+39 0471 932893
Fax:
+39 02 57760140
info@boscarol.it
www.boscarol.it
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
2- 12
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