Follow-Up; Patient Information; Replacement Indications - BIOTRONIK Evity 6 Manuel Technique

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 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 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 regarding modifi-
cation of therapy by reprogramming the device.
Follow-up with the programmer
Use the following procedure for in-house follow-up:
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 Manually perform standard tests if necessary.
6 Possibly evaluate statistics and IEGM recordings.
7 Possibly adjust program functions and parameters.
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8 Transmit the permanent program to the implanted device.
9 Print and document follow-up data (print report).
10 Finish the follow-up for this patient.

Patient Information

Patient ID card
A patient ID card is included in delivery.
• Provide the patient with the patient ID card.
• Request that patients contact the physician in case of uncertainties.
Prohibitive signs
Premises with prohibitive 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 inter-
ference should not be brought into close proximity of the device.
• Draw the patient's attention to special household appliances, security checkpoints,
anti-theft alarm systems, strong electromagnetic fields, cellular phones, and
transmitters among other things.
• Request patients to do the following:
— Use cellular phones on the opposite side of their body from the device.
— Keep the cellular phone at least 15 cm away from the device both during use
and when stowing.

Replacement Indications

Possible charging status
The time span from the beginning of service (BOS) to elective replacement indication
(ERI) is determined by, among others, the following:
• Battery capacity
• Lead impedance
• Pacing program
• Pacing to inhibition ratio
• Pacemaker circuit properties
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