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
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Table of Contents
Table of Contents
Table of Contents
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Intended Medical Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . . . 9
General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Possible Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Precautionary Measures while Programming . . . . . . . . . . . . 18
Magnet Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Explantation and Device Replacement . . . . . . . . . . . . . . . . . . 26
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Pacing and Sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
MRI Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Preset Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Tolerances of Parameter Values. . . . . . . . . . . . . . . . . . . . . . . 36
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42