User Manual
Table Of Contents
- 1 Product Description
- 2 General Safety Instructions
- 3 Implantation
- Implantation Procedure
- Having parts ready
- Keeping an external defibrillator ready
- Unpacking the device
- Checking parts
- Implantation site
- Preventing leakage currents
- Preventing unintentional shock delivery
- Avoiding damage to the header
- Preventing short circuits in the header
- Ensure that connections are clean
- Connecting the lead connector to the device
- Keeping distance between leads
- Implanting
- Applying the programming head
- Establishing telemetry contact
- Activating ICD therapy
- Precautionary Measures while Programming
- Performing standard tests and monitoring the patient
- Cancelling telemetry
- Avoiding critical parameter settings
- Checking for electrodes suitable for the shock path
- Monitoring the patient when setting asynchronous modes
- Setting sensing
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Observing the shock impedance limit
- Preventing recurrence after therapy shock
- Phrenic nerve stimulation that cannot be terminated
- Avoiding risks in the case of exclusive LV pacing
- Recognizing lead failure
- Considering power consumption and service time
- Magnet Response
- Follow-up
- Patient Information
- Replacement Indications
- Explantation and Device Replacement
- Implantation Procedure
- 4 Parameters
- Bradycardia / CRT
- General ICD therapy
- Timing: Basic rate day/night and rate hystereses
- Timing: AV delay
- Timing: Post-shock pacing
- Timing: Upper rate
- Timing: Mode switching
- Timing: Ventricular pacing supression
- Timing: Ventricular pacing
- Timing: Refractory periods and blanking periods
- Timing: PMT protection
- Timing: Rate adaptation via accelerometer
- Timing CLS-Modes: Closed Loop Stimulation
- Pacing: Pulse amplitude and pulse width
- Pacing: Ventricular capture control
- Pacing: atrial capture control
- LV lead configuration with IS-1
- LV lead configuration with IS4
- MRI program
- Tachycardia
- Sensing
- Diagnostics
- Home Monitoring
- Bradycardia / CRT
- 5 Technical Data
17
Follow-up with BIOTRONIK Home Monitoring
®
Monitoring using the Home Monitoring function does not serve to replace regular in-
office appointments with the physician required for other medical reasons. Follow-up
supported by Home Monitoring can be used to functionally replace in-office follow-up
under the following conditions:
•
The patient was informed that the physician must be contacted despite use of the
Home Monitoring function if symptoms worsen or if new symptoms arise.
•
Device messages are transmitted regularly.
•
The physician decides whether the data transmitted via Home Monitoring with
regard to the patient's clinical condition as well as the technical state of the device
system are sufficient. If not, an in-office follow-up needs to be carried out.
Possible early detection due to information gained via Home Monitoring may necessi-
tate an additional in-office follow-up. For example, the data may indicate at an early
stage lead problems or a foreseeable end of service time (ERI). Furthermore, the data
could provide indications of previously unrecognized arrhythmias or modification of the
therapy by reprogramming the device.
Follow-up with the programmer
Use the following procedure for in-office follow-up:
Patient Information
Patient ID card
A patient ID card is included in delivery.
•
Provide the patient with the patient ID.
•
Request that patients contact the physician in case of uncertainties.
Prohibitory signs
Places with prohibitory signs must be avoided.
•
Draw the patient's attention to prohibitory signs.
Possible sources of interference
Electromagnetic interference should be avoided in daily activities. Sources of interfer-
ence should not be brought into close proximity with the device.
•
Draw the patient's attention to special household appliances, security checkpoints,
anti-theft alarm systems, strong electromagnetic fields, cell phones, and transmit-
ters among other things.
•
Request patients to do the following:
—
Use cell phones on the side of their body that is opposite of the device.
—
Keep the cell phone at least 15 cm away from the device both during use and
when stowing.
Replacement Indications
Possible battery levels
•
BOS: Beginning of Service: > 70% charge
•
MOS 1: Middle of Service: 70% to 40% residual charge
•
MOS 2: Middle of Service: < 40% residual charge
•
ERI: Elective Replacement Indication, (i.e. RRT: Recommended Replacement Time)
•
EOS: End of Service
Elective Replacement Indication (ERI)
Elective Replacement Indication can be detected by Home Monitoring.
1 Record and evaluate the ECG.
2 Interrogate the device.
3 Evaluate the status and automatically measured follow-up data.
4 Check the sensing and pacing functions.
5 Possibly evaluate statistics and IEGM recordings.
6 Manually perform standard tests if necessary.
7 Possibly customize program functions and parameters.
8 Transmit the program permanently to the device.
9 Print and document follow-up data (print report).
10 Finish the follow-up for this patient.