Manuels d'utilisation pour Boston Scientific Corporation CRM70514

Table des matières

• general description

  7
• Description

  7
• Indications for Use

  7
• Intended Use

  7
• Contraindications

  7
• Programmer Warnings and Cautions

  7
• General

  7
• Electrostatic Discharge (ESD)

  9
• S-ICD System Warnings and Cautions

  9
• General

  9
• Use of Other Medical Therapies/Diagnostic Procedures

  10
• Electromagnetic Interference (EMI) Outside the Hospital Environment

  11
• S-ICD System Clinical Investigation

  11
• Potential Adverse Events

  12
  • Operation

    13
• Setup of the Q-TECH Programmer

  13
• Packaging

  13
• Programmer Controls and Connections

  13
• Charging the Programmer

  14
• Using the Q-TECH Programmer

  15
• Turning the Programmer On

  15
• Changing the Programmer Volume Level

  16
• Placing the Programmer in Suspend Mode

  16
• Turning the Programmer Off

  17
• Using the Programmer Touch Screen

  17
• Using the Wand

  18
• Navigation

  19
• Screen Header

  19
• Navigation Bar

  20
• Restarting the Programmer

  20
• Configuring the Q-TECH Programmer

  22
• Configuring Programmer Settings

  22
• Date and Time Format

  24
• Time Zone

  24
• Language Preference

  25
• Printer Selection

  25
• Programmer Software Version

  28
• Modes of Operation for the Q-TECH Programmer

  28
• Online Behavior

  28
• Offline Behavior

  29
• Modes of Operation for the SQ-RX Device

  30
• Shelf Mode

  30
• Therapy On Mode

  30
• Therapy Off Mode

  30
• Connecting and Disconnecting from the SQ-RX Device

  31
• Scanning For SQ-RX Devices

  31
• Connecting to the SQ-RX Device

  33
• Connecting to an SQ-RX Device in Shelf Mode:

  33
• Ending a Patient Session

  34
• Programming the SQ-RX Device at Implant

  36
• Entering Electrode Information

  36
• Creating the Patient Chart

  38
• Automatic Setup

  40
• Programming Therapy Parameters

  43
• Defibrillation Testing

  46
• Performing an SQ-RX Follow-up

  49
• Sensing Configuration and Automatic Setup

  49
• Viewing SQ-RX Device Status

  49
• Viewing Stored Episodes

  50
• Printing Reports from the Programmer

  52
• Printing Reports

  52
• Summary Report

  53
• Captured S-ECG Report

  54
• Episodes Report

  55
• S-ECG Features

  56
• S-ECG Rhythm Strip Markers

  56
• S-ECG Scale Settings

  58
• Capture and View S-ECG Strips

  59
• Utilities Menu

  60
• Acquire Reference S-ECG

  61
• Capture All Sense Vectors

  62
• Beeper Control

  63
• Manual Setup

  64
• Smart Charge

  67
• Additional Programmer Functions

  69
• Rescue Shock

  69
• Manual shock

  71
• S-ICD System Magnet Model 4520

  71
  • MAINTENANCE

    72
• Charging the Programmer

  72
• Cleaning the Programmer

  72
• Service

  72
• Maintenance Check

  73
• Safety Measurements

  73
• Programmer End of Life

  73
  • TROUBLESHOOTING

    74
• Inability to Print

  74
• No Printer Available

  74
• Touch Screen Inactive while Connected to AC Power

  74
• Loss of Communication with Printer

  74
• Inability to Communicate With the SQ-RX Device

  75
  • Compliance statements

    76
• Federal Communications Commission (FCC) US

  76
• Essential Performance

  76
• EMI/RFI

  77
  • Declarations tables

    78
  • Table 3: Declaration Electromagnetic Emission

    78
  • Table 4: Declaration Electromagnetic Immunity Part 1

    78
  • Table 5: Declaration Electromagnetic Immunity Part 2

    79
  • Table 6: Recommended Separation Distances

    80
  • Table 7: EMI/RFI Information: Programmer–to–pulse generator

    80
  • Table 8: EMI/RFI Information: Programmer–to–printer (Bluetooth®)

    80
  • Specifications

    81
  • Table 9: Product Guidelines

    81
  • Table 10: Specifications

    81
  • Table 11: Nominal Specifications

    82
  • Definition of package label symbols

    83
  • Table 12: Packaging Symbols: Q-TECH Programmer

    83
  • Table 13: Packaging Symbols: Q-TECH Programmer Wand

    83
  • Warranty

    84
• Limited Warranty

  84