用户手册 — CVRx BAROSTIMIPG1

目录

• 1 SYSTEM DESCRIPTION

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  • Implantable Pulse Generator (IPG)

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  • CVRx Programmer System Model 9010

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    • Programmer Software

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    • Programmer Interface

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  • Optional Accessories for Use with the Neo Legacy System

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    • CVRx Magnet

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    • CVRx Accessory Kit

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    • CSL Repair Kit Model 5010

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• 2 SYMBOLS AND DEFINITIONS

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• 3 INDICATIONS

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• 4 WARNINGS AND PRECAUTIONS

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  • Warnings

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  • Precautions

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  • Implantable Pulse Generator

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    • Warnings

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    • Precautions

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  • Carotid Sinus Lead

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    • Warnings

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    • Precautions

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  • CVRx Programmer System

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    • Warning

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    • Precautions

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  • CVRx Magnet

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    • Precaution

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  • Accessory Kit

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    • Warnings

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    • Precautions

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• 5 CLINICAL SUMMARY AND ADVERSE EVENTS

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• 6 PHYSICIAN TRAINING AND EXPERIENCE

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• 7 NEO LEGACY SYSTEM PREPARATION

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  • How Supplied

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    • Implantable Pulse Generator

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    • Programmer System

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  • Inspection Prior to Use

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    • Implantable Pulse Generator

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  • Materials Recommended for Implantation and/or Explantation

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  • Cleaning the Programmer System

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  • Programmer System Set Up

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• 8 PROGRAMMER SYSTEM OPERATION

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  • Navigating

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  • User Login

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  • After powering up the programmer you will be requested to login. Click the CVRx User and enter the password.

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  • Starting the Application

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  • Connection Dialog

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  • Main Screen

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  • Patient Identification

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  • IPG Status

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    • Current Therapy Status

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    • Quickly–Stopping All Applied Therapies

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    • Battery Life

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    • Lead Impedance

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    • Confirming a Good Telemetry Link

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  • Therapy Settings

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  • Edit and Test Screen

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  • Adjusting the Schedule

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  • Note: The IPG Schedule is in relation to the local time set by the programmer computer. Patients who travel to other time zones and have more than one therapy in their Schedule will experience therapy transitions based on the time zone in use at the time of IPG programming. If the patient travels to a different time zone, the IPG schedule does not change to the new time zone. Clinicians should take this behavior into consideration when programming multiple therapies.IPG Diagnostics.

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  • Estimating Longevity of Implantable Pulse Generator

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• 9 IPG REPLACEMENT PROCEDURE

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  • Recommendations

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  • Antibiotic Coverage

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  • Explantation of Depleted IPG

    25
  • Implantation of Replacement IPG

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  • Pre Discharge Device Testing

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• 10 EXPLANTATION PROCEDURE

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  • Recommendations

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  • Antibiotic Coverage – Not Infected

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  • Antibiotic Coverage – Infected

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  • IPG Explantation

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• 11 INSTRUCTIONS FOR PATIENTS

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• 12 EMERGENCY PERSONNEL INFORMATION

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  • Radiopaque Identifier

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  • ECG Artifact

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  • Temporarily Inhibiting the IPG Output

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• 13 TROUBLESHOOTING

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  • CVRx Contact Information

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  • Programmer System and Warning messages

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• 14 WARRANTY / DISCLAIMER OF WARRANTY

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• 15 REGULATORY NOTICES

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• 16 SPECIFICATIONS OF NONIMPLANTABLE COMPONENTS

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  • Programmer System

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  • Programmer System Components

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  • Computer

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  • Miscellaneous Information

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• 17 SPECIFICATIONS OF IMPLANTABLE COMPONENTS

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  • Pulse Generator

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  • Pulse Generator Parameters

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• 18 ELECTROMAGNETIC COMPATIBILITY DECLARATIONS

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  • Programmer System EMC Precautions

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  • Programmer System RF Specifications

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• 19 R&TTE DECLARATION OF CONFORMITY (DOC)

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