General Safety Instructions; Operating Conditions; Possible Complications - BIOTRONIK Evity 6 Manuel Technique

2 General Safety Instructions

W CAUTION
Safety information
Cardiac electrotherapy is subject to special operating conditions and possible compli-
cations and risks.
• Please take all precautionary measures carefully into account.

Operating Conditions

Technical manuals
The following technical manuals provide information about usage of the device
systems:
— Technical manual for the device
— Technical manual for the HMSC
— Technical manuals for leads
— Technical manuals for the programmer and its accessories
— Technical manuals for the user interface
— Technical manuals for cables, adapters and accessories
• Technical manuals are either included in hard copy form in the storage package or
in digital form on the internet:
manuals.biotronik.com
• Follow all relevant technical manuals.
• Keep technical manuals for later use.
Care during shipping and storage
• Devices are not to be stored close to magnets or sources of electromagnetic inter-
ference.
• Note the effects of the storage period; see Battery Data.
Temperature
Extremely low and high temperatures affect the service time of the battery in the
device.
• Permitted for shipping and storage:
–10°C to +45°C
en • English
Sterile delivery
The device and the screwdriver have been gas-sterilized. Sterility is guaranteed only if
the blister and quality control seal have not been damaged.
Sterile packaging
The device and screwdriver are packaged in 2 separately sealed blisters. The inner
blister is also sterile on the outside so that it can be transferred in a sterile state during
implantation.
Single use only
The device and screwdriver are intended for single use only.
• Do not use the device if the package is damaged.
• The device must not be resterilized and reused.

Possible Complications

General information on medical complications
Complications for patients and device systems generally recognized among practitio-
ners also apply to BIOTRONIK devices.
• Normal complications may include fluid accumulation within the device pocket,
infections, or tissue reactions. Primary sources of complication information include
current scientific and technological knowledge.
• It is not possible to guarantee the efficacy of antiarrythmia therapy, even if the
programs have proven successful during tests or subsequent electrophysiological
examinations. In rare cases the set parameters can become ineffective.
In particular it is inevitable that tachyarrhythmias may be induced.
Skeletal myopotentials
Bipolar sensing and control of sensitivity are adapted by the device to the rate range
of intrinsic events so that skeletal myopotentials are usually not sensed. Skeletal
myopotentials can nonetheless be classified as intrinsic events especially with
a unipolar configuration and/or very high sensitivity and, depending on the interference,
may cause inhibition or antiarrhythmia therapy.
Nerve and muscle stimulation
A device system consisting of a unipolar lead and an uncoated device may result in
undesirable pacing of the diaphragm in the case of an initial or permanent high setting
of the pulse amplitude.
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