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
en • English
27
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-LSD078
Pulse form
The pacing pulse has the following form:
The pulse amplitude reaches its maximum value at the beginning of the pulse (Ua).
With increasing pacing duration (tb), the pulse amplitude is reduced dependent on the
pacing impedance.
Resistance to interference
•
Note on device type VR DX (only devices with a DF-1/IS-1 connection): The EMC
requirements are met as long as atrial sensitivity is set to 1.0 mV (factory settings)
or values ≥ 1.0 mV. Measures must be taken to assure interference-free therapy if
more sensitive values are set.
•
Note on device type HF and HF QP: In the case of unipolar sensing, the requirement
for interference voltages of ≤ 0.3 mV (peak to peak) is met.
Common mode rejection ratio
*Devices with a DF-1/IS-1 connection only; ** Information for device type HF also
applies to device type HF QP.
ATP amplitude
A burst was measured at 500 Ω, an amplitude of 7.5 V (tolerance ± 1.5 V), pulse width of
1.5 ms, R-S1 interval of 300 ms and an S1 count of 5:
Automatic sensitivity control
Measurement of actual values and test signal wave shape: standard triangle. For the
device type VR DX, the programmed atrial sensitivity is intensified by a factor of 4.
Shock energy / peak voltage
With shock path: RV to housing + SVC
Rate Common mode rejection ratio
Atrium: DX* Atrium: DR, HF** V right: VR, DR, HF** V left: HF**
16.6 Hz 76 dB 72 dB 58 dB 55 dB
50 Hz 73 dB 72 dB 65 dB 55 dB
60 Hz 75 dB 71 dB 66 dB 62 dB
ATP amplitude Measured minimum Measured maximum Mean value
RA 7.23 V 7.27 V 4.93 V
RV 7.26 V 7.52 V 5.04 V
LV 7.51 V 7.54 V 5.07 V
Sensitivity Value Tolerance Measured value
A: positive 0.2 mV 0.2 ... 0.5 0.27 mV
A: negative 0.26 mV
DX: A: positive 0.2 mV 0.2 ... 0.52
(0.05 to 0.13)
0.11 mV
DX: A: negative
RV: positive 0.5 mV 0.3 ... 0.7 0.53 mV
RV: negative 0.57 mV
LV: positive 0.5 mV 0.3 ... 0.7 0.53 mV
LV: negative
Shock energy
(Tolerance)
Tolerance
Peak voltage
Measured value
Shock energy
Measured value
Peak voltage
1 J (0.7 ... 1.18) 90 ... 120 V 0.83 J 98.1 V
20 J (15.9 ... 21.6) 440 ... 480 V 17.4 J 462 V
40 J (33.8 ... 41.4) 620 ... 690 V 36.7 J 659 V
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