Benutzerhandbuch für Mintek LV

Inhaltsverzeichnis

• 1. General

  1
• 1.2 Indications

  2
• 1.4 Note to Physician

  3
• 1.5.1 Interactions with Other Medical Therapy

  4
• 1.5.2 Storage and Sterilization

  6
• 1.5.3 Lead Connection and Evaluation

  7
• 1.5.4 Programming and Operation

  8
• 1.5.5 Home Monitoring

  11
• 1.5.6 Electromagnetic Interference (EMI)

  13
• 1.5.7 Home and Occupational Environments

  13
• 1.5.8 Cellular Phones

  14
• 1.5.9 Hospital and Medical Environments

  15
• 1.5.10 Device Explant and Disposal

  15
• 1.7 Clinical Studies

  17
• 1.7.1 Stratos LV Clinical Study – AVAIL CLS/CRT

  17
• 1.7.2 Stratos LV Clinical Study – OVID study

  39
• Endpoint-Complication-free Rate (Safety)

  47
• OPTION CRT/ATx

  49
• 1.7.5 Conclusions Drawn from Studies

  61
• 2. Programmable Parameters

  63
• 2.1.1 Rate-adaptive Modes

  63
• 2.1.2 DDD

  63
• 2.1.3 DDI

  67
• 2.1.4 DVI

  67
• 2.1.5 VDD

  67
• 2.1.6 AAI and VVI

  68
• 2.1.7 AAI, VVI

  68
• 2.1.8 AOO, VOO

  68
• 2.1.9 DOO

  68
• 2.1.10 VDI

  68
• 2.1.11 OFF (ODO)

  69
• 2.3 Timing Functions

  70
• 2.3.1 Basic Rate

  70
• 2.3.2 Rate Hysteresis

  71
• 2.3.3 Scan Hysteresis

  72
• 2.3.4 Repetitive Hysteresis

  74
• 2.3.5 Night Mode

  75
• 2.3.6 Refractory Periods

  76
• 2.3.7 Atrial PMT Protection

  77
• 2.3.8 Ventricular Refractory Period

  78
• 2.3.9 AV Delay

  78
• 2.3.11 Sense Compensation

  80
• 2.3.12 Ventricular Blanking Period

  81
• 2.3.13 Safety AV Delay

  81
• 2.4.1 Pulse Amplitude and Pulse Width

  82
• 2.4.2 Sensitivity

  83
• 2.4.3 Lead Polarity

  83
• 2.6 Antitachycardia Functions:

  86
• 2.6.1 Upper Rate and UTR Response

  86
• 2.8 Mode Switching

  88
• 2.9.1 Protection

  89
• 2.9.2 PMT Detection

  90
• 2.11 Atrial Upper Rate

  92
• 2.13 AES Detection and Pacing

  94
• 2.13.1 AES Detection

  94
• 2.13.2 Post AES Stimulation

  95
• 2.14.1 Rate-Adaptation

  95
• 2.14.2 Sensor Gain

  96
• 2.14.3 Automatic Sensor Gain

  96
• 2.14.4 Sensor Threshold

  97
• 2.14.5 Rate Increase

  97
• 2.14.6 Maximum Activity Rate

  98
• 2.14.7 Rate Decay

  98
• 2.16 Rate Fading

  99
• 2.17.1 Transmission of Information

  102
• 2.17.2 Patient Device

  103
• 2.17.3 Transmitting Data

  103
• 2.17.4 Types of Report Transmissions

  105
• 2.17.5 Description of Transmitted Data

  107
• 2.18.1 Timing

  109
• 2.18.2 Arrhythmia

  109
• 2.18.3 Sensor

  109
• 2.18.4 Sensing

  109
• 2.18.5 Pacing

  109
• 2.18.6 General Statistical Information

  110
• 2.20 Timing Statistics

  111
• 2.20.1 Event Counter

  111
• 2.20.2 Event Episodes

  111
• 2.20.3 Rate Trend

  112
• 2.20.4 Atrial and Ventricular Rate Histogram

  112
• 2.21.1 Tachy Episode Trend

  113
• 2.21.2 AF Classification

  113
• 2.21.3 AES Statistics

  114
• 2.21.4 VES Statistics

  115
• 2.22.1 Sensor Rate Histogram

  116
• 2.22.2 Activity Report

  117
• 2.22.3 Sensor Optimization

  117
• 2.24 Pacing Statistics

  118
• 3. Follow-up Procedures

  119
• 4. Real-Time IEGM

  121
• 5. Battery, Pulse and Lead Data

  123
• 5.3 Testing for Retrograde Conduction

  125
• 5.4.1 Description

  125
• 5.4.2 Burst Stimulation

  126
• 5.4.3 Programmed Stimulation

  126
• 5.4.4 Back up Pacing

  126
• 5.4.5 NIPS Safety Features

  127
• 6. Other Functions/Features

  129
• 6.2 Patient Data Memory

  130
• 6.4 Magnet Effect

  131
• 6.6 Pacing When Exposed to Interference

  132
• 7. Product Storage and Handling

  135
• 7.2 Opening the Sterile Container

  136
• 8. Lead Connection

  139
• 8.2 Lead Connection

  140
• 9. Elective Replacement Indication (ERI)

  145
• 10. Explantation

  149
• 11. Technical Data

  151
• 11.2 Pulse- and Control Parameters

  151
• 11.4 Home Monitoring (Stratos LV-T)

  156
• 11.6 Programmers

  158
• 11.8 Materials in Contact with Human Tissue

  159
• 11.10 Mechanical Data

  160
• 12. Order Information

  161
• Appendix A

  163