User Manual
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
- Preventing leakage currents
- Preventing unintentional shock delivery
- Avoiding damage to the header
- Preventing short circuits in the header
- Ensure that connections are clean
- Connecting the lead connector to the device
- Keeping distance between leads
- Implanting
- Applying the programming head
- Establishing telemetry contact
- Activating ICD therapy
- Precautionary Measures while Programming
- Performing standard tests and monitoring the patient
- Cancelling telemetry
- Avoiding critical parameter settings
- Checking for electrodes suitable for the shock path
- Monitoring the patient when setting asynchronous modes
- Setting sensing
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Observing the shock impedance limit
- Preventing recurrence after therapy shock
- Phrenic nerve stimulation that cannot be terminated
- Avoiding risks in the case of exclusive LV pacing
- Recognizing lead failure
- Considering power consumption and service time
- Magnet Response
- Follow-up
- Patient Information
- Replacement Indications
- Explantation and Device Replacement
- Implantation Procedure
- 4 Parameters
- Bradycardia / CRT
- General ICD therapy
- Timing: Basic rate day/night and rate hystereses
- Timing: AV delay
- Timing: Post-shock pacing
- Timing: Upper rate
- Timing: Mode switching
- Timing: Ventricular pacing supression
- Timing: Ventricular pacing
- Timing: Refractory periods and blanking periods
- Timing: PMT protection
- Timing: Rate adaptation via accelerometer
- Timing CLS-Modes: Closed Loop Stimulation
- Pacing: Pulse amplitude and pulse width
- Pacing: Ventricular capture control
- Pacing: atrial capture control
- LV lead configuration with IS-1
- LV lead configuration with IS4
- MRI program
- Tachycardia
- Sensing
- Diagnostics
- Home Monitoring
- Bradycardia / CRT
- 5 Technical Data
25
5 Technical Data
Mechanical Characteristics
Housing
Devices with a DF-1/IS-1, DF4/IS-1 or DF4/IS4 header:
Materials in contact with body tissue
•
Housing: Titanium
•
Header: Epoxy resin
•
Blind plug and silicone plug: Silopren or silastic
DF4 /IS4 seal: Silastic
X-ray identification
AH
Electrical Characteristics
Standards
The specifications are made according to EN 45502-2-2:2008.
Measuring conditions
If not indicated otherwise, all specifications refer to the following conditions:
•
Ambient temperature: 37ºC ± 2°C
•
Pacing/sensing: 500 Ω ± 1%
•
Shock: 50 Ω ±1%
Factory settings
•
Arrhythmia zones VT1, VT2, VF: OFF
•
Antibradycardia pacing: OFF
•
Home Monitoring: OFF
Telemetry data
•
Nominal carrier frequency: 403.6 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 data 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–TACH70
The code IC in front of the certification/ registration number only indicates that the
technical requirements for Industry Canada are met.
Telemetry data 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-SMC010
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 oper-
ation. This transmitter shall be used only in accordance with the FCC Rules governing
the Medical Device Radiocommunication Service. Analog and digital voice communica-
Type Connector port W x H x D in mm
Volume cm
3
Mass g
VR DF-1 65 x 55 x 12.5 36 86
DF4 65 x 52 x 12.5 34 86
DX DF-1 65 x 55 x 12.5 36 86
—
DR DF-1 65 x 55 x 12.5 36 86
DF4 65 x 56 x 12.5 35 87
HF DF-1 65 x 58.5 x 12.5 37 88
DF4 65 x 56 x 12.5 36 87
HF QP DF4/IS4 65 x 59x 12.5 37 89