User Manual

ManualsBrandsSORIN CRM ManualsElectronicsImplantable pacemaker with RF com.

Table Of Contents

1. General description
2. Intended use and targeted population
- 2.1. Intended use
- 2.2. Indications and targeted population
3. Contraindications and adverse events
- 3.1. General considerations
- 3.2. Adverse events, risks and side effects
4. Warnings
- 4.1. Pacemaker dependent patients
- 4.2. Warnings to patients
- 4.3. Risks related to medical environment
- 4.4. Storage
- 4.5. Packaging
  - 4.5.1. Characteristics of the sterile package
  - 4.5.2. Characteristics of the non-sterile package
5. Clinical studies
- 5.1. Methods
- 5.2. Patients studied
- 5.3. Safety results
- 5.4. Effectiveness results
6. Patient selection and treatment
- 6.1. Specific patient populations
7. Patient counseling information
8. Declaration of conformity
9. Physician guidelines
- 9.1. Physician training
- 9.2. Directions for use
- 9.3. Maintaining device quality
- 9.4. Implantation and device programming
- 9.5. Lead evaluation and lead connection
- 9.6. Programming and pacemaker operation
- 9.7. Rate increases
- 9.8. Generator explant and disposal
10. Patient information
11. How supplied
- 11.1. Sterility
- 11.2. Warranty and replacement policy
12. Implant procedure
- 12.1. Necessary equipment
- 12.2. Packaging contents
- 12.3. Optional equipment
- 12.4. Opening the package
- 12.5. Preparing the pocket
- 12.6. Choosing the type of lead
- 12.7. Measurement of thresholds at implant
- 12.8. Lead connections
- 12.9. Implant considerations
13. Pacemaker interrogation and upgrade
14. Special modes
- 14.1. Nominal mode (Safety mode)
- 14.2. Standby mode
- 14.3. Magnet mode
- 14.4. Response in the presence of interference
15. Functions and parameters
- 15.1. Pacing modes
  - 15.1.1. MRI Mode
- 15.2. Rates
- 15.3. Pacing and Sensing parameters
- 15.4. Refractory periods
- 15.5. Rate response
- 15.6. Therapeutic improvements
- 15.7. Optimizing operation
- 15.8. Follow-up function
- 15.9. Remote monitoring function
16. Patient follow-up
- 16.1. Recommended Replacement Time (RRT)
- 16.2. Follow-up recommendations
- 16.3. Explantation
- 16.4. Programmer tests
- 16.5. Interrogating the diagnostic data (AIDA)
  - 16.5.1. SafeR (Preservation of AV conduction)
- 16.6. Pacemaker identification
17. Standby mode
18. Medical follow-up
- 18.1. Magnet test
  - 18.1.1. Magnet On
  - 18.1.2. Magnet Off
- 18.2. Capture test mode:
- 18.3. Rate test mode:
- 18.4. Threshold tests
  - 18.4.1. Ventricular threshold test
  - 18.4.2. Atrial threshold test
- 18.5. Lead measurements
- 18.6. Statistics
- 18.7. Markers and intracardiac ECG
  - 18.7.1. Markers
  - 18.7.2. Intracardiac ECG
- 18.8. Temporary programming
- 18.9. Memory functions
19. Physical characteristics
20. Electrical characteristics
- 20.1. Current drain at beginning of service
- 20.2. Correspondence between magnet rate and battery life
- 20.3. Battery
- 20.4. Longevity
- 20.5. Radio equipment emission
21. Programmable parameters
- 21.1. Antibradycardia pacing
- 21.2. Remote alerts and warnings
22. Non-programmable parameters
23. Warranty
- 23.1. Article 1: Terms of warranty
- 23.2. Article 2: Terms of replacement
24. Explanation of symbols

Rate responsive

parameters

Models Values Nominal

value

"As

shipped"

value

Sensor choice SR, DR

Twin Trace-MV-G G MV+G

Rate response

mode

(1)

SR, DR

Learn-RR auto-RR fixed-No No Learn

Physical activity SR, DR

Very low-Low-Medium-High-

Very high

Medium Medium

(1) Twenty minutes after the automatic detection of implantation by the device, the as-shipped rate

response mode (NO) is automatically reprogrammed to Learn.

SafeR parameters Models Values Nominal

value

"As

shipped"

value

Max Pause (s) DR

2-3-4 3 3

Long PR at rest

(ms)

200-250-300-350-400-450-500 350 350

Long PR at

exercise (ms)

200-250-300-350-400-450-500 250 250

AVB I switch DR

Rest+Exercise-Exercise Rest+Exer

cise

Rest+Exer

cise

MRI Mode parame-

ters

Models Values Nominal

value

"As

shipped"

value

MRI Mode SR, DR

Auto-Manual-OFF OFF OFF

MRI Pacing Mode DR

DOO-VOO-AOO-OOO DOO DOO

MRI Pacing Mode

(1)

AOO/VOO-OOO AOO/VOO AOO/VOO

MRI Pacing Rate

(ppm)

(2)

50-55-60-65-70-75-80-85-90-95-

100-105-110-115-120 (± 2 ppm)

80 80

MRI Pacing Rate

(ppm)

(2)

50-55-60-65-70-75-80-85-90-95-

100-105-110-115-120 (± 2 ppm)

90 90

MRI Monitoring

Period (h)

SR, DR

2h-4h-6h-12h-24h-48h-3 days-

7 days-10 days

24h 24h

(1) The as-shipped and nominal values (AOO/VOO) depend on the chamber selected.

(2) Default pacing rate is 20 min

-1

over programmed basic rate.

Automatic detec-

tion of implantation

parameters

Models Values Nominal

value

"As

shipped"

value

Auto implant

detection

SR, DR

ON-OFF OFF ON

SafeR Auto launch DR

ON-OFF OFF ON

Right Atrial

Autothreshold

Auto-Monitor-OFF OFF Monitor

Right Ventricular

Autothreshold

SR, DR

Auto-Monitor-OFF OFF Monitor

Lead Polarity

Switch

SR, DR

ON-OFF OFF OFF

Remote monitoring SR, DR

ON-OFF OFF OFF

21. PROGRAMMABLE PARAMETERS

72 ALIZEA – UA10414A