USER MANUAL (Instruction for Use) SW 6.1
Safety
Version 6.1.6 dated 2020-01-31 EN Page 22 of 201
2.4 Manufacturer’s Responsibility
Manufacturer and dealer are only responsible for proper operation, reliability and security of the
device when:
Service personnel authorized by SCHWIND eye-tech-solutions exclusively carry out
transport, installation, initial operation, changes, service and maintenance.
The power connection in the room in which the laser is operated complies with the legal
regulations and technical specifications of SCHWIND eye-tech-solutions concerning the
installation.
The device and equipment is operated in accordance with the specifications in the
AMARIS User Manual and accompanying documents.
2.4.1 Training of User and Operating Personnel
As with any technological highly-developed medical device, the operation of the excimer laser
requires special training and abilities of the user personnel.
IMPORTANT NOTE
The SCHWIND AMARIS excimer laser may only be operated by specially
trained physicians or surgeons who have mastered the functions of the laser
and who possess the necessary skills to use it in accordance with the
instructions in this User Manual.
Each surgeon has ultimate responsibility for the treatment as well as
postoperative measures and follow-ups.
WARNING!
Risk of injury!
Insufficient training of the user can give rise to human errors when using the
device with the consequent risk of injury to the patient.
Demand or agree regular training upgrades, whenever you feel that you or
your team need further support.
SCHWIND eye-tech-solutions or authorized representative will instruct and train the user
personnel in accordance with this user manual.
The completion of training for the responsible AMARIS operators and other persons involved in
operation, care, maintenance of the excimer laser, should be documented in the Medical
Apparatus Book. The maintenance of the Medical Apparatus Book is an obligation of the
operating company.
The Medical Apparatus Book is a part of the equipment documentation provided with the
AMARIS excimer laser by SCHWIND eye-tech-solutions.
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