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
11
3 Implantation
Implantation Procedure
Having parts ready
The following parts that correspond to the requirements of the EC Directive 90/385/EEC
are required:
•
BIOTRONIK device with blind plug and screwdriver
•
BIOTRONIK leads and lead introducer set
—
Single-chamber device: one bipolar ICD lead with 1 or 2 shock coils for the
ventricle
—
Dual-chamber device: one bipolar lead for the atrium and one bipolar ICD lead
for the ventricle with 1 or 2 shock coils
—
Triple-chamber device: an additional unipolar or bipolar or quadripolar LV lead
•
The lead connections DF-1, DF4 as well as IS-1 and IS4 are permitted. Use only
adapters approved by BIOTRONIK for leads with different lead connections or leads
from other manufacturers.
•
BIOTRONIK programmer (with integrated SafeSync RF telemetry or with separate
SafeSync Module) and approved cables
•
External multi-channel ECG device
•
Keep spare parts for all sterile components.
Keeping an external defibrillator ready
To be able to respond to unforeseeable emergencies or possible technical failures of
the device:
•
Keep an external defibrillator and paddles or patch electrodes ready.
Inadequate therapy due to defective device
If an unpacked device is dropped on a hard surface during handling, electronic parts
could be damaged.
•
Use a replacement device.
•
Return the damaged device to BIOTRONIK.
Unpacking the device
•
Peel the sealing paper off of the outer blister at the marked position in the direction
indicated by the arrow. The inner blister must not come into contact with persons
who have not sterilized their hands or gloves, nor with non-sterile instruments!
•
Take hold of the inner blister by the gripping tab and take it out of the outer blister.
•
Peel the sealing paper off of the sterile inner blister at the marked position in the
direction indicated by the arrow.
Checking parts
Damage to any of the parts can result in complications or technical failures.
•
Check for damage before and after unpacking all parts.
•
Replace damaged parts.
•
Upon delivery, the tachyarrhythmia therapy function in the ICD is deactivated.
The ICD must only be implanted in this state.
•
Leads must not be shortened.
Implantation site
•
Depending on lead configuration and the patient's anatomy, the ICD is generally
implanted subpectorally on the left side.
Preventing leakage currents
Leakage currents between the tools and the device must be prevented during implanta-
tion.
•
Electrically insulate the patient.
W
WARNING
417634--B_GA_Intica-ProMRI_mul.fm Page 11 Friday, November 6, 2015 8:13 PM