User Manual
Table Of Contents
- 1. General description
- 2. Intended use and targeted population
- 3. Contraindications and adverse events
- 4. Warnings
- 5. Clinical studies
- 6. Patient selection and treatment
- 7. Patient counseling information
- 8. Declaration of conformity
- 9. Physician guidelines
- 10. Patient information
- 11. How supplied
- 12. Implant procedure
- 13. Pacemaker interrogation and upgrade
- 14. Special modes
- 15. Functions and parameters
- 16. Patient follow-up
- 17. Standby mode
- 18. Medical follow-up
- 19. Physical characteristics
- 20. Electrical characteristics
- 21. Programmable parameters
- 22. Non-programmable parameters
- 23. Warranty
- 24. Explanation of symbols
Pacing/Sensing Models Values Nominal
value
"As
shipped"
value
Atrial or ventricular
pulse amplitude (V)
(1)
DR
1-1.5-2-2.5-3-3.5-4-5-6 (± 20 %)
7.5 (± 30 %)
5.0 3.5
Pulse amplitude (V)
(1)
SR
1-1.5-2-2.5-3-3.5-4-5-6 (± 20 %)
7.5 (± 30 %)
5.0 3.5
Atrial or ventricular
pulse width (ms)
(1)
DR
0.12-0.25-0.35-0.5-0.6-0.75-0.85
-1 (± 35 µs)
0.5 0.35
Pulse width (ms)
(1)
SR
0.12-0.25-0.35-0.5-0.6-0.75-0.85
-1 (± 35 µs)
0.5 0.35
Atrial sensitivity
(mV)
(2)(3)(4)
DR
0.1* (± 0.025 mV ± 60 %)
0.2*-0.3*-0.4 (± 0.025 mV ±
40 %)
0.6-0.8-1-1.2-1.5-1.8-2-2.2-2.5-
2.7-3-3.5-4-4.5-5-6 (± 20 %)
*only available in bipolar mode
1.0 0.6
Ventricular
sensitivity (mV)
(2)(3)(4)
DR
0.4 (± 0.025 mV ± 40 %)
0.6-0.8-1-1.2-1.5-1.8-2-2.2-2.5-
2.7-3-3.5-4-4.5-5-6-8-10-15
(± 20 %)
2.5 1.5
Sensitivity (mV)
(2)(3)(4)
SR
0.4 (± 0.025 mV ± 40 %)
0.6-0.8-1-1.2-1.5-1.8-2-2.2-2.5-
2.7-3-3.5-4-4.5-5-6-8-10-15
(± 20 %)
2.5 1.5
Atrial or ventricular
sensing polarity
(5)
DR
Unipolar-Bipolar Unipolar Bipolar
Sensing polarity
(5)
SR
Unipolar-Bipolar Unipolar Bipolar
Atrial or ventricular
pacing polarity
(5)
DR
Unipolar-Bipolar Unipolar Bipolar
Pacing polarity
(5)
SR
Unipolar-Bipolar Unipolar Bipolar
Atrial or ventricular
lead polarity switch
DR
ON-OFF OFF OFF
Ventricular lead
polarity switch
SR
ON-OFF OFF OFF
(1) If the programmed value is higher than the nominal value, the programmed value will be applied
for the nominal settings.
(2) Values are measured using a positive and negative triangular signal of 2/13 ms.
(3) For sensitivity settings below 3 mV, the pacemaker may detect noise lower than the level specified
in clause 27.5.1 of standard EN 45502-2-1 and clause 4.5.2.1 of standard ISO 14117:2019.
(4) For sensitivity settings below 1 mV, the pacemaker may detect noise lower than the level specified
in clause 27.4 of standard EN 45502-2-1 and clause 4.4.1 of standard 14117:2019.
(5) As soon as the detection of implantation has been confirmed, the lead configuration is
automatically programmed according to auto implantation pacing polarity.
21. PROGRAMMABLE PARAMETERS
70 ALIZEA – UA10414A