Revision 5.5
15
3.2
Installation and Initial Start-Up
Installation and initial commissioning may be performed only by Gebrüder Martin or authorized
service partners. For further information see section 5.2 “Setting up the MCO 25 plus”,
page 27.
CAUTION
Danger of physical injury!
Any person that handles the device in any way must have fully read and understood the
contents of these instructions for use. Improper handling that does not comply with these
instructions can lead to injury or to damage to the device.
Before commissioning, the operator must ensure that the following points are complied with:
•
Acceptance by a medical technician of the customer.
•
Written appointment of a laser safety officer by the operator, see § 6 BGV B2.
•
Training of a person responsible for the device and the personnel.
•
Medical product log created.
•
Registration of the device with the trade association and with the authority responsible for
occupational safety.
•
Handover of the fully operational device and training of the personnel by Gebrüder Martin
or an authorized representative.
•
Compliance with all safety notes.
•
Observance of all notes regarding electromagnetic compatibility see section 15 “Guidelines
and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 113.
•
Knowledge of the procedures and measures in case of faults and malfunctions. The
accident prevention directive (BGV B2) for the protection of medical personnel must be
complied with during the medical application of the device. Medical applications include
diagnostic, surgical or therapeutic applications with laser light in the broadest sense. The
operator and security officers (e.g. laser safety officer) are responsible for the
implementation of all safety measures to protect the patient, the user and other persons
present during laser operation.
