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Stratos LV/LV-T Technical Manual 135
7. Product Storage and
Handling
7.1 Sterilization and Storage
Stratos CRT-Ps are shipped in a cardboard box, equipped with a
quality control seal and product information label. The label
contains the model specifications, technical data, serial number,
expiration date, and sterilization and storage information for the
particular CRT-P. The box contains a double blister container
with the CRT-P and product documentation.
The Stratos CRT-P and its accessories have been sealed in a
container and gas sterilized with ethylene oxide. To assure
sterility, the container should be checked for integrity prior to
opening. If a breach of sterility is suspected, return the CRT-P to
BIOTRONIK.
CAUTION
Storage (temperature) – Recommended storage temperature
range is 5° to 55°C (41°-131°F). Exposure to temperatures
outside this range may result in CRT-P malfunction (see
Section 7.1).
Low Temperatures – Exposure to low temperatures (below
0°C) may cause a false elective replacement indication to be
present. If this occurs, warm the device to room temperature
and reset the ERI with magnet application (see Section 7.1).
Handling – Do not drop. If an unpackaged CRT-P is
dropped onto a hard surface, return it to BIOTRONIK (see
Section 7.1).