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
26
tions 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: QRITACH70
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 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: In the case of unipolar sensing, the requirement for inter-
ference voltages of ≤ 0.3 mV (tip to tip) is met.
Common mode rejection ratio
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 setting
Measurement of actual values and test signal wave shape: standard triangle. For the
device type 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
N.n. Hz N.n. dB N.n. dB N.n. dB N.n. dB
N.n. Hz N.n. dB N.n. dB N.n. dB N.n. dB
N.n. Hz N.n. dB N.n. dB N.n. dB N.n. dB
* only devices with a DF-1/IS-1 connection.
ATP amplitude Measured
minimum
Measured
maximum
Mean value
RV N.n. V N.n. V N.n. V
LV N.n. V N.n. V N.n. V
Sensitivity Value Tolerance Measured value
A: positive N.n. mV N.n. N.n. mV
A: negative N.n. mV
DX: A: positive N.n. mV N.n.
(N.n.)
N.n. mV
DX: A: negative N.n. mV
RV: positive N.n. mV N.n. N.n. mV
RV: negative N.n. mV
LV: positive N.n. mV N.n. N.n. mV
LV: negative N.n. mV
Shock energy
(Tolerance)
Tolerance peak
voltage
Measured value
Shock energy
Measured value
Peak voltage
1 J (N.n.) N.n. V N.n. J N.n. V
20 J (N.n.) N.n. V N.n. J N.n. V
45 J (N.n.) N.n. V N.n. J N.n. V