Supplement to the instructions for use Polaris 600 13
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Supplement to the instructions for use
Add this supplement to the instructions for use of the medical
device.
This supplement describes the specifics of the Polaris 600 Mobile
surgical light and is valid only in conjunction with the instructions
for use for the Polaris 600 surgical light. The complete technical
data can be found in the instructions for use.
The supplement updates the information of the instructions for use
in the following chapters:
For your safety and that of your patients
Product-specific safety information
Do not use the Polaris 600 Mobile near magnetic
resonance imagers
Intended use
Additional light
As an addition to an existing surgical light system in the operating
room, with battery to bridge a mains power supply failure.
Single light
As a single light, the Polaris 600 Mobile light is intended to be used
as a surgical light or examination light in operating or treatment
rooms for diagnostic and treatment purposes which can be
interrupted without posing a hazard to the patient in case the light
fails.
If used as a single light, the Polaris 600 Mobile light is classified as
"small surgical light" in accordance with IEC 60601-2-41.
Instructions for use Part number Edition
Polaris 600 9054591 2nd edition – August 2015 and higher
WARNING
To properly use this medical device, read and comply with
the instructions for use and this supplement.
WARNING
Danger of device malfunction and of personal injury
Magnetic fields can affect the correct functioning of the
medical device and thus endanger the patient or user.
Do not use the medical device near magnetic resonance
imagers (MRI, NMR, NMI).
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