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
24
Implantation
Replacement Indications
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
The following are the defined pacemaker operational statuses:
• BOS: Beginning of Service: > 90%
• ERI: Elective Replacement Indication (i.e., RRT: Recommended Replacement
Time)
• EOS: End of Service
ERI activation
ERI detection is automatically activated after the following events:
• Successful auto-initialization
ERI display
ERI is displayed as follows:
• On the programmer after interrogation of the pacemaker
• By a defined decrease in the basic rate as well as the magnet rate
Rate decrease
The decrease of basic rate and magnet rate is defined as follows:
• In the following modes, the pacing rate decreases by 11%:
DDD(R); DDT; D00(R); VDD(R); VDI(R); VVI(R); VVT; AAI(R); AAT; A00(R)
• In the modes DDI(R) and DVI(R), only the VA interval is extended by 11%. This
reduces the pacing rate by up
to 11%, depending on the configured AV delay.
Change of the mode with ERI
This change depends on the mode which is set. It is displayed on the programmer.
• Single-chamber modes: VVI
• Dual-chamber modes: VDD
• Triple-chamber modes: Dual-chamber pacing, one biventricular setting is kept
Deactivated functions with ERI
The following functions are deactivated:
• Atrial pacing
• Night program
• Rate adaptation
• Atrial and ventricular capture control
• Rate fading
• Atrial overdrive pacing
• IEGM recordings
• Statistics
• Home Monitoring
• Rate hysteresis
• Ventricular pacing suppression