6
Description
Packaging, Sterility, Storage, and Disposal
Box and label
The lead is delivered in a box bearing a quality control seal and a product
information label.
The label contains the following information about the lead:
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Name of model
•
Technical properties and data
•
Serial number
•
Use by date
•
Details on sterility
•
Storage information
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CAUTION
Risk to sterility due to damaged blister
To ensure sterility, the container should be checked for damage prior to opening.
Do not use a lead if you are unsure of its sterility.
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CAUTION
Resterilization and reuse
This lead is intended for single use only. Reuse of leads can result in infections,
embolisms and damage to the device.
Resterilization and reuse are prohibited.
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CAUTION
Improper storage
If the specified time period and temperature range for storage are exceeded, then
the documented properties of the lead can no longer be guaranteed. Technical
malfunctions - as well as decreased effectiveness of the steroid in the case of
steroid-eluting leads - may result.
Sterility
The lead and its accessories are packaged in a double blister and sterilized with
ethylene oxide. As a result, the inner blister is also sterile on the outside.
Storage
Maintain the following storage conditions:
Disposal
An explanted lead must be disposed of as medical waste in an environmentally
friendly and proper manner.
The lead does not contain any materials which require any further provisions.
Storage temperature
Maximum storage duration
5–50°C
2 years
