Estella Pulse Generators - BIOTRONIK USA - News

10. Product Storage and Handling10.1 Sterilization and StorageEstella Pulse Generators Technical Manual 105The pulse generator is shipped in a cardboard box, equipped with aquality control seal and product information label. The label containsthe model specifications, technical data, serial number, expiration date,and sterilization and storage information of the pulse generator. Thebox contains a double container with the pulse generator and productdocumentation.The pulse generator and its accessories have been sealed in a containerand gas sterilized with ethylene oxide. To assure sterility, the containershould be checked for integrity prior to opening. If a breach of sterility issuspected, return the pulse generator to BIOTRONIK.CautionStorage (temperature)—Recommended storage temperaturerange is 5° to 55°C (41°-131°F). Exposure to temperaturesoutside this range may result in pulse generator malfunction.Handling—Do not drop. If an unpackaged pulse generator isdropped onto a hard surface, return it to BIOTRONIK.CautionFOR SINGLE USE ONLY—Do not resterilize the pulse generatoror accessories packaged with the pulse generator, they areintended for one-time use.Device Packaging—Do not use the device if the packaging iswet, punctured, opened or damaged because the integrity of thesterile packaging may be compromised. Return the device toBIOTRONIK.Storage (magnets)—Store the device in a clean area, awayfrom magnets, kits containing magnets, and sources ofelectromagnetic interference (EMI) to avoid damage to thedevice.Use Before Date—Do not implant the device after the USEBEFORE DATE because the device may have reduced longevity.If a replacement pulse generator is needed, contact your localBIOTRONIK representative.