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3.2
Installation and Initial Commissioning
Installation and initial commissioning may be performed only by Gebrüder Martin or authorized
service partners.
CAUTION
Danger of physical injury!
Any person that handles the device in any way must have fully read and understood the
contents of this document. 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 also section 13
•
"Guidelines and Manufacturer's Declaration Regarding Electromagnetic
Compatibility (EMC)", page 70.
Knowledge of the operational 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 the security officers (e. g. laser safety officer) are responsible for the
implementation of all safety measures to protect the patient, the attending physician and
other persons present during laser operation.
14
Instructions for Use
Laser Surgical Unit diomax
®
1550
Revision 2
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