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
8
Storing programs
There are different therapy programs:
•
Parameter settings effective for the most common indications in pre-configured
programs (Program Consult).
•
For special indications, individual parameter settings can be stored in up to three
therapy programs.
ProMRI devices recognize magnetic resonance imaging devices
Intica has a sensor which can reliably recognize a magnetic resonance imaging device.
This sensor can be activated for a maximum of 14 days using the MRI AutoDetect
function during an interrogation.
If the patient comes near a magnetic resonance imaging device within the time set, the
implanted device recognizes the imaging device and automatically activates the preset
MRI program. Reprogrammation to the permanent program occurs also automatically
when the imaging device is left.
Home Monitoring functions
•
The device automatically sends information to the transmitter once a day. It also
sends messages related to events, which are immediately forwarded to the Service
Center. In addition to this, test messages can be initiated using the programmer.
•
Appointments for Home Monitoring-supported follow-ups can be scheduled via the
HMSC.
•
Important medical information in the device messages include the following:
—
Atrial and ventricular arrhythmias
—
Parameters relevant to leads in the atrium and ventricle: pacing thresholds,
sensing amplitudes, impedances
—
Current statistics
—
IEGM online HD with up to 3 high definition channels
2 General Safety Instructions
Operating Conditions
Technical manuals
The following technical manuals provide information about usage of the device
systems:
— Technical manual for the device
— Technical manual for the HMSC
— Technical manuals for leads
— Technical manuals for the programmer and its accessories
— Technical manuals for the user interface
— Technical manuals for cables, adapters and accessories
•
Technical manuals are either included in hard copy form in the storage package or
in digital form on the internet: manuals.biotronik.com.
•
Follow all relevant technical manuals.
•
Reserve technical manuals for later use.
Care during shipping and storage
•
Devices must not be stored or transported close to magnets or sources of electro-
magnetic interference.
•
Note the effects of the storage duration; see Battery Data.
Delivery in shipment mode
The device is delivered in shipment mode to protect the battery; capacitor reforming
required during storage could result in controlled extended charge times of the shock
capacitors.
•
The shipment mode is displayed on the programmer after the initial interrogation
(it is deactivated during implantation by the first valid (in-range) measurement of
the pacing impedance).
Temperature
Extremely low and high temperatures affect the service time of the battery in the
device.
•
Permitted for shipping and storage are +5°C to +45°C.
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