OCULUS Myopia Master Instruction Manual page 13

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4 Safety Instructions
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Information about the operation of an ME system
The Myopia Master® and a connected computer form a medical electrical
system (ME system) according to IEC 60601-1. If you connect additional
devices, such as, for example a printer, those devices become part of the
ME system.
Make sure that all devices of the ME system meet the requirements
of IEC 60601-1 or IEC 60950-1/IEC 62368-1.
Instructions for Operation
Before first use: Let OCULUS or an authorized dealer train you in the
operation of the Myopia Master®.
Never operate a damaged Myopia Master®.
Only operate the Myopia Master® with the original accessories
supplied by us and only when the unit is in technically perfect
condition.
Do not cover the ventilation openings.
Do not touch the patient and the device at the same time.
Make sure that the device cannot tip over by leaning against it or
sitting on it.
Do not put the Myopia Master®, including rechargeable battery or
cable, down onto devices that produce heat, heaters (for example
radiators), microwaves or similar.
Only operate the device if you have understood the operating
instructions.
Instructions for Laser Use
Attention
Risk of personal injury or material damage due to invisible laser radiation
The Myopia Master® contains a Class 1 laser according to IEC 60825-1:
2014. It is an encapsulated laser system. When the Myopia Master® cover
is opened, you may be exposed to invisible, Class 3R (5 mW) laser
radiation.
Never open the unit.
For authorized service personnel only: When doing maintenance
jobs, avoid looking directly into the laser beam.
Instructions for Maintenance
In order to retain the high measurement accuracy of the Myopia Master®
OCULUS Optikgeräte GmbH recommends to perform a maintenance
service every two years or after 25000 scans. Additionally to that it is
Instruction Manual Myopia Master® (G/68100/EN Rev08)

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