Zeiss OPMI Lumera i, Instructions For Use Manual

Page: 9 / 184

Version 8.0
G-30-1720-en
Page 9
OPMI Lumera i Safety measures
Notes for the operator
Correct operation of the device is required to ensure safe use,
• so please familiarize yourself thoroughly with these Instructions for Use
before starting up the instrument.
• Please comply with the Instructions for Use of the other system components
as well. You can obtain additional information from ZEISS Service.
• The Instructions for Use contain warnings and safety information that
describe the possible residual risks.
Follow these instructions carefully to reduce the residual risks for users
and patients to a minimum.
Duties of the operator
• Only operate the device within the scope of its intended use.
• Note the labels attached to the system! (See Page 28.)
Legal regulations • Check regularly that the legal regulations applicable in your country with
regard to accident prevention and work safety are being complied with.
• If required under the applicable national laws and regulations, connect the
device to the “special substitute power supply”.
Notification of the
manufacturer and authorities
• If a serious incident occurs in connection with this medical device affecting
the operator or another person, the operator (or person responsible) must
report this serious incident to the manufacturer or seller of the medical
product. In the European Union, the operator must report this serious
incident to the competent authority in his country.
Notes on the system • Ensure that the installation conditions and the use of the device meet
surgical requirements:
– Low vibration
– Clean environment
– Avoidance of extreme mechanical stress