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
38
Technical Data
Electrical Characteristics
Electrical Characteristics
Components and input values
Electrical characteristics determined at 37°C, 500 Ω:
Electrically conductive surface
The device housing has the form of a flattened ellipsoid. The electrically conductive
area is for:
• Single and dual-chamber devices: 30 cm
2
• Triple-chamber devices: 33 cm
2
Telemetry data
• MICS frequency: 402 - 405 MHz
• Maximum power of transmission: < 25 µW (-16 dBm)
International radio
certification
Devices with BIOTRONIK Home Monitoring
®
are equipped with an antenna for
wireless communication.
• Telemetry information for Australia:
This product is in compliance with the Australian
"Radiocommuniations Act 1992" and therefore it is labelled according to
the "Radiocommunications (Compliance Labelling - Devices) Notice."
• Telemetry information for Canada:
This device must neither interfere with meteorological and earth resources
technology satellites nor with meteorological stations working in the 400,150 to
406,000 MHZ band, and it must accept any interference received, including
interference that may cause undesired operation.
This device will be registered with Industry Canada under the following number:
IC: 4708A-PNP
The code IC in front of the certification/registration number only indicates that
the technical requirements for Industry Canada are met.
• Telemetry information for Japan:
In accordance with Japanese law, this device has been assigned an
identification number under the "Ordinance concerning certification of
conformity with technical regulations etc. of specified radio equipment",
Article 2-1-8.
R 202-LSE015
• Telemetry information for the USA:
Telemetry data for the USA: This transmitter is authorized by rule under the
Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and
must not cause harmful interference to stations operating in the 400.150-
406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers
used to communicate weather data), the Meteorological Satellite, or the Earth
Exploration Satellite Services and must accept interference that may be caused
by such stations, including interference that may cause undesired operation.
This transmitter shall be used only in accordance with the FCC Rules governing
the Medical Device Radiocommunication Service. Analog and digital voice
communications are prohibited. Although this transmitter has been approved by
the Federal Communications Commission, there is no guarantee that it will not
receive interference or that any particular transmission from this transmitter
will be free from interference.
This device will be registered with Federal Communications Commission under
the following number:
FCC ID: QRIPNP
Circuit technology Dycostrate
Input impedance > 10 kΩ
Pulse form Biphasic, asymmetric
Polarity Cathodic