User Manual
Table Of Contents
- Edora 8
- 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
- Overview: Implanting
- Avoid damage to the header
- Preventing short circuits in the header
- Keeping distance between leads
- Connecting the lead connector to the device
- Applying the programming head
- Establishing wandless telemetry
- Auto-initialization
- Behavior during auto- initialization
- Precautionary Measures while Programming
- Checking the device system
- Performing standard tests and monitoring the patient
- Do not interrupt wandless telemetry during a treatment
- Cancelling telemetry
- Avoiding critical parameter settings
- Manually setting lead polarity
- Setting sensing
- Setting the sensitivity
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Phrenic nerve stimulation that cannot be terminated
- Avoiding risks in the case of exclusive left ventricular pacing
- If an ICD is implanted at the same time, do not permit unipolar pacing
- Recognizing lead failure
- Consider power consumption and service time
- Magnet Response
- Follow-up
- Patient Information
- Replacement Indications
- Explantation and Device Replacement
- Implantation Procedure
- 4 Parameters
- 5 Technical Data
22
Implantation
Follow-up
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
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 regarding modification 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.
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.