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
17
Implantation
Implantation Procedure
Connecting the lead connector
to the device
Applying the programming
head
The programming head (PGH) features a diagram of the device. This is used to
assist in positioning the head to ensure proper telemetry.
• Make sure the PGH is positioned correctly.
Establishing wandless
telemetry
The programmer must be no less than 20 cm and no more than 3 m from the
device; ideally there should be no hindrances between the patient and the
programmer.
• Switch on wandless telemetry on the programmer.
• Apply the programming head for about 2 s until successful initialization is
displayed on the programmer:
The wandless telemetry symbol is displayed in the navigator and the
signal strength is displayed in the status line.
• Remove the programming head.
Note: After auto-initialization, all parameters are activated as in the standard
program.
Auto-initialization
Auto-initialization begins automatically once the first connected lead is sensed.
Auto-initialization is usually terminated 10 minutes after connection of the first
lead. If no other program has been transferred in the meantime, the device
subsequently works with active automatic functions in the factory settings or with
the preset program of the user.
Manual setting of the lead polarity or measurement of lead impedances is not
necessary.
Behavior during auto-
initialization
• During transmission of a permanent program:
Auto-initialization is terminated and the transferred program is active.
• During testing:
Tests cannot be performed during auto-initialization; stop it beforehand.
Auto-initialization will not be continued upon completion of the test.
1 Remove stylets and stylet guides.
2 • Connect the unipolar or bipolar IS-1 lead connector for the right ventricle
to RV.
• Connect the unipolar or bipolar IS-1 lead connector atrium to A.
• Connect the unipolar or bipolar IS-1 or the quadripolar IS4 lead connector
for the left ventricle to LV.
3 Push the lead connector into the header without bending the conductor until
the connector tip becomes visible behind the set screw block.
4 If the lead connector cannot be inserted completely, the set screw may be
protruding into the drill hole of the set screw block. Carefully loosen the set
screw without completely unscrewing it, so that it does not become tilted
upon retightening.
5 Use the screwdriver to perpendicularly pierce through the slitting in the
center of the silicone plug until it reaches the set screw.
6 Turn the set screw clockwise until the torque control starts (you will hear a
clicking sound).
7 Carefully withdraw the screwdriver without retracting the set screw.
• When the screwdriver is withdrawn, the silicone plug automatically seals
the lead connection safely.