BIOTRONIK Evia HF - 8 Product Storage and Handling; Sterilization and Storage

Chapter 8 Product Storage and Handling
Evia HF / HF-T Technical Manual
PAGE 91
8. Product Storage and Handling
8.1 Sterilization and Storage
The pulse generator is shipped in a cardboard box, equipped with a quality control seal and product
information label. The label contains the model specications, technical data, serial number, expiration
date, and sterilization and storage information of the pulse generator. The box contains a double
container with the pulse generator and product documentation.
The pulse generator 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 pulse generator to BIOTRONIK.
CAUTION
Storage (temperature) – Recommended storage temperature range
is -10° to 45°C (14°-113°F). Exposure to temperatures outside this
range may result in pulse generator malfunction.
Handling – Do not drop. If an unpackaged pulse generator is
dropped onto a hard surface, return it to BIOTRONIK.
CAUTION
FOR SINGLE USE ONLY – Do not resterilize the pulse generator or
accessories packaged with the pulse generator, they are intended for
one-time use.
Device Packaging – Do not use the device if the packaging is wet,
punctured, opened or damaged because the integrity of the sterile
packaging may be compromised. Return the device to BIOTRONIK.
Storage (magnets) – Store the device in a clean area, away from
magnets, kits containing magnets, and sources of electromagnetic
interference (EMI) to avoid damage to the device.
Use Before Date – Do not implant the device after the USE BEFORE
DATE because the device may have reduced longevity.
If a replacement pulse generator is needed, contact your local BIOTRONIK representative.