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1 Important information regarding safe use
55000-00011_002_01 – 1756789 – 2017-09-06
• The device may only be operated, cleaned, disinfected and maintained by
qualified personnel.
1.4.1
Initial commissioning
Scope
This instruction manual is only valid after successful initial operation by the operator
or an installer authorised by the manufacturer.
• The device must be thoroughly cleaned and disinfected before its first use.
• Once the device has been released for use, the information in this instruction
manual will be binding for the user.
1.4.2
Availability of the instruction manual
Obligation to inform
The instruction manual is part of the device and must therefore be kept in a place in
the immediate vicinity of the device to allow consultation regarding safety
instructions and important operating information at any time.
• Never hand the device to third parties without the valid instruction manual.
Ensure that the instruction manual provided with the device is valid by checking
the identity and version number.
1.4.3
Guarantee
Guarantee
Trumpf Medical guarantees the safety and functionality of the device as long as the
following conditions are met:
• the device is exclusively used for the purpose intended and is operated and
maintained in accordance with the provisions of this instruction manual
• only original spare parts or accessories approved by Trumpf Medical are used
• no modifications are made to the device
• inspections and maintenance work are carried out at the time intervals specified
• an initial commissioning is carried out and the device is released for operation
with a handover declaration
1.4.4
Maintenance and repair
The device or parts thereof may only be maintained or repaired by:
• Trumpf Medical Customer Service
• authorised service companies trained by Trumpf Medical
• the operator's service personnel when trained and authorised by Trumpf Medical
1.4.5
Service life of the device
Trumpf Medical products are designed in compliance with all safety and maintenance
requirements for a service life of 10 years.
• This life span includes the functionality of the product when used according to
the specifications in the instruction manual, a guaranteed service and the supply
with spare parts.
• Trumpf Medical makes use of a quality management system certified in
accordance with DIN EN ISO 13485 for all company processes.
• This guarantees:
– Top quality
– Easy operation
– Functional design
– Optimisation for the intended purpose
1.5
Date of manufacture
The rating plate indicates the date of manufacture of the device. The position of the
rating plate on the device is shown in Chapter 4.1, page 24.