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
27
Battery Data
Battery characteristics
The following data is provided by the manufacturers:
Storage period
The storage period affects the battery service time.
•
Devices should be implanted within N.n. months between the manufacturing date
and the use by date (indicated on the package).
•
If the ICD is implanted shortly before the use by date, the expected service time
may be reduced by up to N.n. months.
Calculation of service times
•
The services times have been calculated as follows – in all chambers depending on
the device type:
—
Pulse amplitude: 2.5 V
—
Pulse width: 0.4 ms
—
Pacing impedance: 500 Ω
—
Basic rate: 60 bpm
—
Home Monitoring: ON, 1 device message each day and 12 IEGM online HD
transmissions per year
—
Diagnostic functions and recordings: permanently set
•
Capacitor reforming is performed N.n. times per year and therefore at least
N.n. maximum charges for shocks have to be assumed per year even if less
than N.n. are delivered.
Calculation of the number of shocks
Calculation of the maximum number of shocks: Service time [in years] x number of
shocks per year
Service times single-chamber
Service times with GB 2992 or LiS 3410 RR battery, subject to change:
Service times dual-chamber
Service times with GB 2992 or LiS 3410 RR battery
(only devices with DF-1/IS-1 connection), subject to change:
Service times triple-chamber
Service times with GB 2992 or LiS 3410 RR battery, subject to change:
Manufacturer GREATBATCH, INC.
Clarence, NY 14031
LITRONIK GmbH & Co
01796 Pirna, Germany
Battery type GB 2992 LiS 3410 RR
Battery ID number shown on the
programmer
3 N.n.
Device type VR, (DX), DR, HF
Battery voltage at ERI 2.5 V N.n. V
Charge time at BOS 10 s N.n. s
Charge time at ERI 12 s N.n. s
Usable capacity until ERI 1590 mAh N.n. mAh
Usable capacity until EOS 1730 mAh N.n. mAh
Pacing
Service time [in years] at number of shocks per year
48121620
0, 15, 50, 100%
N.n. N.n. N.n. N.n. N.n.
Pacing
Service time [in years] at number of shocks per year
48121620
0, 15, 50, 100%
N.n. N.n. N.n. N.n. N.n.
Pacing
Service time [in years] at number of shocks per year
48121620
0, 15, 50, 100%
N.n. N.n. N.n. N.n. N.n.