Bowa TissueSeal PLUS Instrucciones De Uso página 82

7 Preparation
7.8.
38 TissueSeal / TissueSeal PLUS
The manufacturer accepts no responsibility whatsoever for
the use of other sterilization methods, such as sterilization
using ethylene oxide, formaldehyde, radiation or low-
temperature plasma.
1. Observe the following if such methods are used:
•
EN ISO 14937 / ANSI AAMI ISO 14937;
•
standards relevant to the method.
2. Demonstrate the suitability and effectiveness of the
method, taking into account the specific product
geometry in the context of validation (including
investigation of sterilization medium residues if
appropriate).
Storage
1. Store the ligation instrument in a location where it is
protected against:
•
strong mechanical stresses such as shocks,
falling or blows;
•
direct exposure to sunlight;
•
X-ray radiation.
2. Store the ligation instrument in a dry place at room
temperature.
The storage life of the sterilized ligation instrument depends
on the type of packaging and the storage conditions.
The shipping box is not intended for storing the device.
Storage conditions:
Temperature:
Relative humidity:
Atmospheric pressure:
–20 to +50 °C
0 to 75%, non-condensing
500–1600 mbar
MN031-443-S0-20110112-EN