User Manual
Table Of Contents
- Cover
- 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 connector ports are clean
- Overview: Implanting
- Connecting the device
- Keeping distance between leads
- Applying the programming head
- Establishing RF telemetry
- Activating ICD therapy
- Precautionary Measures while Programming
- Performing standard tests and monitoring the patient
- Cancelling telemetry
- Avoiding critical parameter settings
- Avoiding risks in the case of exclusive LV pacing
- Monitoring the patient when setting asynchronous modes
- Complying with the morphology criteria
- Setting sensing
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Avoiding AV crosstalk
- Observing the shock impedance limit
- Preventing recurrence after therapy shock
- Phrenic nerve stimulation that cannot be terminated
- Note the reduced pulse amplitude due to a battery voltage drop
- Observe when inducing short-term cardiac arrest
- Checking the settings of the DX lead
- Checking for electrodes suitable for the shock path
- 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 suppression
- Timing: Ventricular pacing
- Timing: Ventricular multi pole pacing
- Timing: Refractory periods and blanking periods
- Timing: PMT protection
- Timing: Rate adaptation via accelerometer
- Timing: Rate adaptation via CLS
- Pacing: Pulse amplitude and pulse width
- Pacing: Atrial capture control
- Pacing: Ventricular capture control
- Lead configuration LV on IS-1 connection
- Lead configuration LV on IS4 connection
- MRI program
- Tachycardia
- Sensing
- Diagnostics
- Home Monitoring
- Bradycardia / CRT
- 5 Technical Data
26
5 Technical Data
Mechanical Characteristics
Housing
Devices with header for DF-1 and DF4 connector:
Materials in contact with body tissue
•
Housing: Titanium
•
Header: epoxy, polysulfone; DF4 seal: silastic
•
Silicone plugs and blind plugs (if applicable): Silopren or silastic
X-ray identification
NK
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 ± 2ºC
•
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 for Home Monitoring:
•
MISC frequencies: 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 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-TACHNT2
The code IC in front of the certification/ registration number only indicates that the
technical requirements for Industry Canada are met.
•
Telemetry information for the USA:
This transmitter is authorized by rule under the Medical Device Radiocommunica-
tion 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 Meteoro-
logical Satellite, or the Earth Exploration Satellite Services and must accept inter-
ference 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 trans-
mitter will be free from interference.
This device will be registered with Federal Communications Commission under the
following number:
FCC ID: QRITACHNT2
Type Lead connector W x H x D in mm
Volume [cm
3
]
Mass g
VR DF-1 65 x 55 x 11 33 82
DF4 65 x 54 x 11 31 81
VR DX DF-1 65 x 55 x 11 33 82
DR DF-1 65 x 55 x 11 33 82
DF4 65 x 56 x 11 32 82
HF DF-1 65 x 58.5 x 11 34 83
DF4 65 x 56 x 11 33 82
HF QP DF-1 65 x 60.5 x 11 36 86
DF4 65 x 58.5 x 11 36 87
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