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
30
Legend for the Label
Label on the package
The label icons symbolize the following:
Manufacturing date Use by
Storage temperature Order number
Serial number Product identification
number
Dangerous voltages! European approval mark
Contents Consult the instructions for
use
Sterilized with ethylene oxide
Do not resterilize Single use only.
Do not reuse!
Do not use if packaging is
damaged
Non-sterile
Transmitter with non-ionizing radiation at designated
frequency
NON
STERILE
Label icon on devices with
ProMRI
®
:
MR conditional: Patients having a device system
implanted whose components are labeled with this
symbol on the packaging can be examined using an
MR scan under precisely defined conditions.
TP2
Compatibility with telemetry protocol version 2
of BIOTRONIK Home Monitoring
Example
Device:
NBG code and compatible leads
Example
Factory settings for therapy: OFF
Screwdriver
Examples of the connector allocation:
DF-1/IS-1, DF4/IS-1, DF4/IS4/IS-1
Bipolar IS-1 connector
Unipolar IS-1 connector
Unipolar DF-1 connector
IS4 connector, DF4 connector
417634--B_GA_Intica-ProMRI_mul.fm Page 30 Friday, November 6, 2015 8:13 PM