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Lumax VR ICD Series
BIOTRONIK Lumax VR ICD Series - User Manual
176 pages
Manual
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Lumax
Family of Implantable Cardioverter
Defibrillators and Cardiac
Resynchronization Therapy
Defibrillators
•
VR ICD
•
VR-T ICD
•
DR ICD
•
DR-T ICD
•
HF CRT-D
•
HF-T CRT-D
Technical Manual
2
Table of Contents
Main Page
Table of Contents
3
System Description
9
Indications and Usage
11
Contraindications
12
Warnings and Precautions
12
Sterilization, Storage, and Handling
15
Device Implantation and Programming
15
Lead Evaluation and Connection
17
Follow-Up Testing
19
Pulse Generator Explant and Disposal
19
Hospital and Medical Hazards
19
Lead System Evaluation
20
Home and Occupational Hazards
21
Cellular Phones
21
Lead to Device Connection
21
Electronic Article Surveillance (EAS)
22
Home Appliances
22
Home Monitoring
23
Potential/Observed Effects of the Device on Health
24
Potential Adverse Events
24
Observed Adverse Events
25
Clinical Studies
35
Kronos LV-T Study
35
Tupos Lv/Atx Study
37
Patient Selection and Treatment
56
Individualization of Treatment
56
Specific Patient Populations
57
Patient Counseling Information
58
Evaluating Prospective CRT-D/ICD Patients
58
Cardiac Resynchronization Therapy (CRT)
61
Sensing (Automatic Sensitivity Control)
64
Right Ventricular Sensitivity Settings
65
Minimum Right Ventricular Threshold
67
Atrial Sensitivity Settings
67
Minimum Atrial Threshold
68
Left Ventricular Sensitivity Settings
68
Minimum Left Ventricular Threshold
69
Far Field Protection
69
Additional Sensing Parameters
70
Automatic Threshold Measurement (ATM)
71
Functional Description
71
Intra-Thoracic Impedance Measurement
73
Functional Description
73
Ventricular Tachyarrhythmia Detection
74
VF Classifications
75
VT Interval Counters
75
VT Classification
75
SMART Detection
76
Onset
77
Stability
77
Sustained VT Timer
78
VT Monitoring Zone
78
Atrial Monitoring Zone
79
Tachyarrhythmia Redetection
79
VT Redetection
79
SMART Redetection
80
Forced Termination
80
VF Redetection
80
Tachyarrhythmia Termination
80
Tachyarrhythmia Therapy
80
Therapy Options
81
Anti-Tachycardia Pacing (ATP)
81
Shock Therapy
84
Progressive Course of Therapy
90
Bradycardia Therapy
91
Bradycardia Pacing Modes
91
Basic Rate
92
Night Rate
93
Rate Hysteresis
93
Dynamic AV Delay
96
Iopt
99
Upper Tracking Rate
99
Mode Switching
101
PMT Management
102
VES Discrimination after Atrial Sensed Events
105
Rate Adaptive Pacing
106
Pulse Amplitude
107
Pulse Width
107
Post Ventricular Atrial Refractory Period
108
PVARP after VES
108
Auto PVARP
108
Noise Response
108
Post Shock Pacing
109
EP Test Functions
109
P and R-Wave Amplitude Measurements
109
Pacing Impedance Measurements
110
Shock Impedance Measurements
111
Testing for Retrograde Conduction
111
Pacing Threshold
112
Arrhythmia Induction Features
112
Manual Shock
113
Test Shock
113
Manual ATP
114
Emergency Shock
114
Special Features
115
ICD Therapy Status
115
Home Monitoring
115
Real-Time IEGM Transmission
125
Capacitor Reforming
126
Patient and Implant Data
126
System Status
127
HF Monitor Statistics
127
Holter Memory
129
Timing Statistics
130
Atrial Arrhythmias
132
Ventricular Arrhythmias
132
Sensor
132
Sensing
132
Impedances
133
Automatic Threshold
133
Implant Preparation
136
Opening the Sterile Container
141
Pocket Preparation
142
Blind Plug Connection
145
Program the ICD/CRT-D
146
Implant the ICD/CRT-D
147
General Considerations
152
Longevity
153
Lumax 300/340 Devices
154
Lumax 500/540 Devices
155
Explantation
158
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BIOTRONIK Lumax VR ICD Series Specifications
General
Brand
BIOTRONIK
Model
Lumax VR ICD Series
Category
Medical Equipment
Language
English
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