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DOK-ID:UTX01G01 BE #5100063
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
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.
Medical Device
Indicates that the product is a medical device.
1.4. Reporting Requirements according to Regulation (EU) 2017/745
In accordance with the relevant legal regulations, serious incidents that have occured in connection
with a MAVIG medical device must be reported to MAVIG and to the responsible national
authorities in the country in which the user is active. In this sense, incidents are reportable if the
use of the medical device directly or indirectly led, might have let or might lead to the death or the
temporary or permanent serious deterioration of a patient's, user's or other person's state of
health.