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DOK-ID: MDX01G02, BE# 6600014
1.
General Information
1.1. Manufacturer
MAVIG GmbH
Stahlgruberring 5
81829 Munich
Germany
Phone
+49 (0) 89 420 96 - 0
Fax
+49 (0) 89 420 96 - 200
info@mavig.com
Web
www.mavig.com
1.2. Operation and Operator
Only appropriately trained personnel may operate, clean and disinfect the product (medical and
radiological technical knowledge in accordance with country specific regulations).
The instructions for use are valid only after a properly conducted first commissioning.
Product must be thoroughly cleaned and disinfected before first use.
1.3. Symbols, Safety and Warning instructions
SAFETY-
RELEVANT
Safety relevant instructions are mandatory and must be followed.
Non-observance could result in
injury
or
death
of one or more persons. You
must read and understand these instructions before starting up the systems.
CAUTION
Cautions must be observed, otherwise the device may be
damaged
or
malfunction
. You must read and understand these instructions before
starting up the system.
Not sterilizable
The product cannot be sterilized with ethylene oxide, irradiation, aseptic
processing techniques, steam or dry heat.
.
1.4. Reporting Requirements according to Regulation (EU) 2017/745
Since the products are not a medical device in the sense of the EU Medical Device Regulation
2017/745 (MDR), there are also no statutory reporting obligations according to the EU Medical
Device Regulation 2017/745 (MDR).
