BIOTRONIK ProMRI Estella SR Manual Tecnico página 12

After Implantation
Follow-up
Follow-up intervals
Follow-ups must be performed at regular, agreed intervals.
• Following the lead ingrowth phase, approximately 3 months after implantation, the
first follow-up should be carried out by the physician using the programmer (in-
office follow-up).
• The next in-office follow-up should be carried out once a year and no later than
12 months after the last in-office follow-up.
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 if symptoms worsen
or if new symptoms arise despite of the use of the Home Monitoring function.
• 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 has to be carried out.
Possible early detection due to information gained via Home Monitoring may
necessitate 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-house follow-up:
1 Record and evaluate the external ECG.
2 Check the sensing and pacing function.
3 Interrogate the device.
4 Evaluate the status and automatically measured follow-up data.
5 Possibly evaluate statistics and Holter/IEGM recording.
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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.
Notes for the Physician
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.
Prohibitive signs
Draw the patient's attention to prohibitive signs.
•Places with prohibitive signs must be avoided.
Possible sources of interference
Electromagnetic interference should be avoided in daily activities. Sources of
interference should not be brought into close proximity with the device.
• Draw the patient's attention to special household appliances, safety locks, anti-
theft devices, strong electromagnetic fields, cell phones and transmitters among
other things.
• Request patients to do the following:
— Use cell phones on the opposite side of their body from the device.
— Keep the cell phone at least 15 cm away from the device both during use and
when storing.
Magnet application by patients
If patients are performing their own magnet application, the synchronous magnet
response has to have been programmed. Patients should also know the following:
• When may the magnet be used?
In cases of severe dizziness and indisposition.
• How long is the magnet placed on the pacemaker?
1 to 2 s.
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