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 specifications, 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.
Summary of Contents for Evia HF
Page 1: ...Cardiac Rhythm Management Heart Failure Therapy Evia HF HF T Evia HF HF T Technical Manual...
Page 8: ...Chapter Table of Contents Evia HF HF T Technical Manual PAGE vi...
Page 12: ...Chapter 2 Indications Evia HF HF T Technical Manual PAGE 4...
Page 14: ...Chapter 3 Contraindications Evia HF HF T Technical Manual PAGE 6...
Page 98: ...Chapter 7 Product Storage and Handling Evia HF HF T Technical Manual PAGE 90...
Page 104: ...Chapter 9 Lead Connection Evia HF HF T Technical Manual PAGE 96...
Page 118: ...Chapter 10 Elective Replacement Indication ERI Evia HF HF T Technical Manual PAGE 110...
Page 130: ...Chapter 13 Order Information Evia HF HF T Technical Manual PAGE 122...
Page 132: ...Chapter 14 Order Information Evia HF HF T Technical Manual PAGE 124...
Page 136: ...PAGE 128 Appendix A Evia HF HF T Technical Manual...
