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Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
PAGE 10
OFF Mode Use of the OFF mode should be avoided in pacemaker dependent patients. The OFF mode
can be transmitted as a temporary program only to permit evaluation of the patient’s spontaneous rhythm.
Myopotential Sensing The filter characteristics of BIOTRONIK pulse generators have been optimized
to sense electrical potentials generated by cardiac activity and to reduce the possibility of sensing
skeletal myopotentials. However, the risk of pulse generator operation being affected by myopotentials
cannot be eliminated, particularly in unipolar systems. Myopotentials may resemble cardiac activity,
resulting in pulse generator pulse inhibition, triggering and/or emission of asynchronous pacing pulses,
depending on the pacing mode and the interference pattern. Certain follow-up procedures, such as
monitoring pulse generator performance while the patient is doing exercises involving the use of
pectoral muscles, as well as Holter monitoring, have been recommended to check for interference
caused by myopotentials. If sensing of myopotentials is encountered, corrective actions may include
selection of a different pacing mode or sensitivity.
Muscle or Nerve Stimulation Inappropriate muscle or nerve stimulation may occur with unipolar
pacing when using a non-coated pulse generator.
CLS Rate-Adaptation
Under certain circumstances (e.g., EMI, lead dislodgment), the Evia CRT-P
device may not be able to obtain a useable impedance measurement as required for CLS rate-adaptive
pacing. At this point, CLS rate-adaptation will be inactive until the situation is corrected. Rate-adaptation
may be programmed to switch to motion based adaptation.
Programmed to Triggered Modes When programmed to triggered modes, pacing rates up to the
programmed upper limit may occur in the presence of either muscle or external interference.
Triggered Modes While the triggered modes (DDT, VVT, and AAT) can be programmed permanently,
the use of these modes is intended as a temporary setting in situations where maintaining the
programming head in place would be impossible or impractical (i.e., during exercise testing or extended
Holter monitoring) or as a short term solution to pulse generator inhibition by extracardiac interference.
To avoid the potential for early battery depletion, it is important that the triggered modes are not used
for long term therapy, and that the pulse generator is returned to a non-triggered permanent program.
4.5 Home Monitoring
BIOTRONIK’s Home Monitoring system is designed to notify clinicians in less than 24 hours of changes
to the patient’s condition or status of the implanted device. Updated data may not be available if:
• The patient’s CardioMessenger is off or damaged and is not able to connect to the Home
Monitoring system through an active telephone link.
• The CardioMessenger cannot establish a connection to the implanted device.
• The telephone and/or Internet connection do not operate properly
• The Home Monitoring Service Center is off-line (upgrades are typically completed in less than
24 hours)
Patient’s Ability
Use of the Home Monitoring system requires the patient and/or caregiver to follow
the system instructions and cooperate fully when transmitting data.
If the patient cannot understand or follow the instructions because of physical or mental challenges,
another adult who can follow the instructions will be necessary for proper transmission.
Electromagnetic Interference (EMI) Precautions for EMI interference with the Evia CRT-Ps are
provided in Section 4.6 . Sources of EMI including cellular telephones, electronic article surveillance
systems, and others are discussed therein.