Stratos LV/LV-T Technical Manual 135

7. Product Storage and Handling

7.1Sterilization 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).