•
Storage temperature and equilibration.
Recommended storage temperatures are 0°C–50°C
(32°F–122°F). Allow the device to reach a proper temperature before using telemetry communication
capabilities, programming or implanting the device because temperature extremes may affect initial
device function.
•
Device storage.
Store the pulse generator in a clean area away from magnets, kits containing magnets,
and sources of EMI to avoid device damage.
•
Use by date.
Implant the pulse generator and/or lead before or on the USE BY date on the package
label because this date re
fl
ects a validated shelf life. For example, if the date is January 1, do not
implant on or after January 2.
Implantation
•
Expected bene
fi
ts.
Determine whether the expected device bene
fi
ts provided by programmable options
outweigh the possibility of more rapid battery depletion.
•
Evaluate patient for surgery.
There may be additional factors regarding the patient’s overall health
and medical condition that, while not related to device function or purpose, could render the patient a
poor candidate for implantation of this system. Cardiac health advocacy groups may have published
guidelines that may be helpful in conducting this evaluation.
•
Lead compatibility.
Prior to implantation, con
fi
rm the lead-to-pulse generator compatibility. Using
incompatible leads and pulse generators can damage the connector and/or result in potential adverse
consequences, such as undersensing of cardiac activity or failure to deliver necessary therapy.
•
Telemetry wand.
Make sure a sterile telemetry wand is available should loss of ZIP telemetry occur.
Verify that the wand can easily be connected to the programmer and is within reach of the pulse generator.
•
Line-powered equipment.
Exercise extreme caution if testing leads using line-powered equipment
because leakage current exceeding 10 µA can induce ventricular
fi
brillation. Ensure that any line-powered
equipment is within speci
fi
cations.
8
