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
8
Product Description
System Overview
NBG codes
AAIR or VVIR is the NBG code for the antibradycardia mode of the single-chamber
device:
DDDR is the NBG code for the antibradycardia mode of the dual-chamber device:
DDDRV is the NBG code for the antibradycardia mode of the triple-chamber device:
BIOTRONIK Home Monitoring
®
In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:
• With Home Monitoring, diagnostic and therapeutic information and technical
data are automatically sent to a stationary or mobile transmitter via an antenna
in the device header. The data are encrypted and sent from the transmitter to
the BIOTRONIK Service Center via the cellular phone network.
• The received data are deciphered and evaluated. Each physician can set the
criteria for evaluation to be used for each patient and can configure the time of
notification via e-mail, SMS or fax.
• A clear overview of the results of this analysis is displayed for the attending
physicians on the protected internet pl
atform Home Monitoring Service Center
(HMSC).
• Data transmission from the device is performed with a daily device message.
• Device messages, which indicate special events in the patient's heart or in the
device, are forwarded with the following message.
• A test message can be initiated at any time using the programmer to
immediately check the Home Monitoring function.
Order numbers for Edora
The devices can be obtained as follows:
Package contents
The storage package includes the following:
• Sterile packaging with device
• Serial number label
• Patient ID card
• Warranty booklet
Note: The technical manual pertaining to the device is either included in hard copy
form in the storage package or in digital form on the internet.
The sterile packaging includes the following:
•Device
• Screwdriver
A/V Pacing in the atrium or ventricle
A/V Sensing in the atrium or ventricle
I Pulse inhibition in the atrium and ventricle
R Rate adaptation
D Pacing in the atrium and ventricle
D Sensing in the atrium and ventricle
D Pulse inhibition and pulse triggering
R Rate adaptation
D Pacing in the atrium and ventricle
D Sensing in the atrium and ventricle
D Pulse inhibition and pulse triggering
R Rate adaptation
V Multisite pacing in both ventricles
Edora 8 SR 407164 Edora 8 DR-T 407145
Edora 8 SR-T 407157 Edora 8 HF-T 407138
Edora 8 DR 407152 Edora 8 HF-T QP 407137