Manufacturer; Ce Mark, Applicable Rules And Regulations; User Instructions For Safe Operation And Operator Qualification Requirements - akrus ak 5003M Manual De Usuario

1.4

Manufacturer

AKRUS GmbH & Co KG
Otto-Hahn-Straße 3
D-25337 ELMSHORN
 int. +49 (0) 4121 791930
FAX int. +49 (0) 4121 791939
1.5

CE mark, applicable rules and regulations

The device complies with the following Regulations for medical devices.
o MDD 93/42 EEC
o DIN / ISO 60601-1
o DIN / ISO 60601-1-2 EMC
o UMDNS No
o Medical Device Class I
The device meets the requirements of MDD 93/42/EEC and the corresponding national requirements
of the Medical Devices Act MDA (Medizinprodukte Gesetz MPG).
User must observe the national legal requirements governing the prevention of accidents.
1.6

User instructions for safe operation and operator qualification requirements

Before using this medical device, please carefully read and observe the safety instructions and
Caution
Risk of operat-
ing errors
o Proper handling and use of the medical device is essential to its safe operation.
o Operation of the medical device only in accordance with the intended use.
o Do not operate the medical device in explosive or hazardous environments. The medical de-
vice must not be operated, with the exception of very minute quantities, in the presence of
combustible anesthetics, or volatile solvents like alcohol, benzene or the like.
o Do not set up the medical device in humid or damp rooms. Never expose the product to
sprinkling, dripping or splashing water.
o Pay special attention to and carefully read any emphasized safety advice or information in
this user manual.
297G001e.docx
13-961
recommendations listed in this manual
The device may only be installed, operated, used and maintained by
persons who have been properly trained or who have the required
knowledge and experience to do so. Please also adhere to the na-
tional qualification guidelines applicable in your country.
2019-04-15
Email: info@akrus.de
Website: www.akrus.de
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