sorin PLATINIUM SonR CRT-D 1811 Manuals

sorin PLATINIUM SonR CRT-D 1811 Manuals

Manuals and User Guides for sorin PLATINIUM SonR CRT-D 1811. We have 1 sorin PLATINIUM SonR CRT-D 1811 manual available for free PDF download: Implant Manual

sorin PLATINIUM SonR CRT-D 1811 Implant Manual

sorin PLATINIUM SonR CRT-D 1811 Implant Manual (73 pages)

Implantable cardioverter defibrillator with cardiac resynchronization therapy

Brand: sorin | Category: Medical Equipment | Size: 1 MB

Table of Contents

Table of Contents
5
1 General Description

7
2 Indications

8
3 Contraindications

9
4 Warnings and Precautions

10
5 Adverse Events

15
- MSP Study
  15
- Potential Adverse Events
  16
6 Clinical Studies

18
- MSP Clinical Study
  18
7 Patient Selection and Treatment

22
- Individualization of Treatment
  22
- Specific Patient Populations
  23
8 Patient Counselling Information

24
9 Declaration of Conformity

25
10 Physician Guidelines

27
- Physician Training
  27
- Directions for Use
  27
- Maintaining Device Quality
  27
- Programming Recommendation
  28
11 Patient Information

29
12 How Supplied

30
- Sterility
  30
- Warranty and Replacement Policy
  30
13 Device Description

31
14 Implant Procedure

33
- Necessary Equipment
  33
- Packaging
  33
- Optional Equipment
  33
- Before Opening the Package
  34
- Prior to Implantation
  34
- Device Placement
  34
- Choosing the Type of Lead
  34
- Shock Configuration (+ -> -)
  35
- Measurement of Thresholds at Implant
  36
- Leads Connection
  36
- Device Implantation
  38
- Tests and Programming
  38
15 Special Modes

39
16 Main Functions

42
- Automatic Lead Measurements
  42
- Atrial Tachyarrhythmia Management
  42
- Ventricular Tachyarrhythmia Management
  42
- Pacing
  43
- Sensing
  43
- Sonr CRT Optimization
  44
- Follow-Up Function
  44
- Remote Monitoring Function
  44
17 Patient Follow-Up

47
- Follow-Up Recommendations
  47
- Holter Function
  47
- Recommended Replacement Time (RRT)
  48
- Explantation
  48
- Defibrillator Identification
  49
18 Supplemental Information

50
- Adverse Events in the Safer (AAI <> DDD) Study
  50
- Safer (AAI <> DDD) Clinical Study
  51
19 Physical Characteristics

53
- Materials Used
  53
20 Electrical Characteristics

54
- Table of Delivered Shock Energy and Voltage
  54
- Battery
  54
- Longevity
  55
21 Programmable Parameters

57
22 Non Programmable Parameters

68
23 Limited Warranty

69
24 Patents

70
25 Explanation of Symbols

71

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