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General Safety Instructions
Operating Conditions
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General Safety Instructions
General Safety Instructions2417804Technical ManualEnticos 4/8
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CAUTION
Safety information
Cardiac electrotherapy is subject to special operating conditions and possible
complications and risks.
Operating Conditions
Technical manuals
The following technical manuals provide information about usage of the device
systems:
— Technical manual for the device
— Technical manual for the HMSC
— Technical manuals for leads
— Technical manuals for the programmer and its accessories
— Technical manuals for the user interface
— Technical manuals for cables, adapters and accessories
•
Technical manuals are either included in hard copy form in the storage package
or in digital form on the internet:
manuals.biotronik.com
•
Follow all relevant technical manuals.
•
Keep technical manuals for later use.
Care during shipping and
storage
•
Devices are not to be stored close to magnets or sources of electromagnetic
interference.
•
Note the effects of the storage period; see Battery Data.
Temperature
Extremely low and high temperatures affect the service time of the battery in the
device.
•
Permitted for shipping and storage:
–10°C to +45°C
Sterile delivery
The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only
if the blister and quality control seal have not been damaged.
Sterile packaging
The device and screwdriver are each packaged in 2 separately sealed blisters. The
inner blister is also sterile on the outside so that it can be transferred in a sterile
state during implantation.
Single use only
The device and screwdriver are intended for single use only.
•
Do not use the device if the package is damaged.
•
The device must not be resterilized and reused.
•
Please take all precautionary measures carefully into account.
