ED01_REV01-2020 IFU OB2012-2P_ENG
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MANUFACTURED 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 manufacturer and medical device:
• Oscar Boscarol applies a quality management system compliant with international standards ISO 13485
and ISO 9001
• The medical device OB2012 (in all its configurations) is compliant with MDD 93/42/EEC (as subsequently
amended) and bears the CE marking (CE 0123 notified body TÜV SÜD PRODUCT SERVICE GmbH)
• The medical device meets the essential requirements described in annex I of MDD 93/42/EEC
Information on these operating instructions:
• This document contains important information for safe, effective and compliant use of the medical device
• Use this information to train users and confirm their training
• This manual may not be modified in any way (not even partially). Only the device manufacturer can make
changes when necessary.
• These instructions must always accompany the device. We recommend using the electronic version and
making it available on operator PDAs, tablets and cell phones
These operating instructions apply to the following devices:
OB 2012 FA
OB 2012 LINER