BIOTRONIK Lumax 640 Gebrauchsanweisung Seite 11

Implanting
1 Prepare the vein.
2 Implant the leads, perform the measurements, and fixate the leads.
3 Form the device pocket.
4 Connect the lead connector to the device.
5 Insert the device.
6 Guide the fixation suture through the opening in the header and fixate the
device in the prepared device pocket.
7 Close the device pocket.
8 Check the device with standard tests.
Applying the programming head
On top of the programming head (PGH) is a diagram of the device to be implanted. 
This is used to assist in positioning the head to ensure proper telemetry.
• Make sure the PGH is positioned correctly.
Establishing telemetry contact
The programmer (or the SafeSync Module) must not be moved more than 3 m away
from the implanted device; ideally there should be no obstacles between the patient
and the programmer.
• Switch on RF telemetry on the programmer.
• Apply the programming head for about 2 s until successful initialization is displayed
on the programmer:
The SafeSync symbol is displayed in the navigator and the signal
strength is displayed in the status bar.
• Remove the programming head.
Activating ICD therapy
• Load the device program that is suitable for the device type in the programmer.
• Activate ICD therapy.
• Shipment mode is permanently deactivated once the leads have been connected
and initial measurement of the pacing impedance has been performed. The device
data are saved.
• Take precautionary measures while programming
• If the device induces tachycardia while programming ATPs or does not deliver
adequate therapy in the DFT test: use emergency shock or an external defibrillator.
Precautionary Measures while Programming
Performing standard tests and monitoring the patient
Critical conditions can occur for the patient even during standard tests due to
inadequate parameter settings or interrupted telemetry.
• Ensure sufficient patient care even during tests.
• After the threshold test, check to determine whether the threshold is clinically and
technically justifiable.
• Continuously monitor the ECG and the patient's condition.
• Cancel testing if necessary.
Cancelling telemetry
Programmer interference or interrupted telemetry during performance of temporary
programs (follow-up tests) can result in inadequate pacing of the patient. This is the
case if the programmer can no longer be operated due to a program error or
a defective touch screen and therefore the temporary program cannot be terminated.
Under these circumstances, it is helpful to cancel telemetry, in which case the device
automatically switches to the permanent program.
• In the case of telemetry with programming head: lift the PGH by at least 30 cm.
• In the case of RF telemetry: switch off and reposition the programmer.
• Turn off possible sources of interference.
Avoiding critical parameter settings
No modes and parameter combinations that pose a risk to the patient should be set.
• Prior to setting rate adaptation, determine the patient's capacity for strain.
• Check compatibility and effectiveness of parameter combinations after making
settings.
Checking for electrodes suitable for the shock path
Three different shock paths can be set. Two of these form an electrical path to the
housing of the implanted device.
• For the RV -> SVC shock path a second shock coil must be available (dual shock
coil).
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