Manual De UsuarioTabla de contenidos1 SYSTEM DESCRIPTION5Implantable Pulse Generator (IPG)5CVRx Programmer System Model 90106Programmer Software6Programmer Interface6Optional Accessories for Use with the Neo Legacy System7CVRx Magnet7CVRx Accessory Kit7CSL Repair Kit Model 501072 SYMBOLS AND DEFINITIONS83 INDICATIONS94 WARNINGS AND PRECAUTIONS10Warnings10Precautions10Implantable Pulse Generator11Warnings11Precautions11Carotid Sinus Lead12Warnings12Precautions12CVRx Programmer System12Warning12Precautions12CVRx Magnet13Precaution13Accessory Kit13Warnings13Precautions135 CLINICAL SUMMARY AND ADVERSE EVENTS146 PHYSICIAN TRAINING AND EXPERIENCE157 NEO LEGACY SYSTEM PREPARATION16How Supplied16Implantable Pulse Generator16Programmer System16Inspection Prior to Use16Implantable Pulse Generator16Materials Recommended for Implantation and/or Explantation16Cleaning the Programmer System16Programmer System Set Up178 PROGRAMMER SYSTEM OPERATION18Navigating18User Login18After powering up the programmer you will be requested to login. Click the CVRx User and enter the password.18Starting the Application18Connection Dialog18Main Screen19Patient Identification19IPG Status19Current Therapy Status19Quickly–Stopping All Applied Therapies19Battery Life19Lead Impedance19Confirming a Good Telemetry Link20Therapy Settings20Edit and Test Screen21Adjusting the Schedule22Note: 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.23Estimating Longevity of Implantable Pulse Generator239 IPG REPLACEMENT PROCEDURE25Recommendations25Antibiotic Coverage25Explantation of Depleted IPG25Implantation of Replacement IPG26Pre Discharge Device Testing2810 EXPLANTATION PROCEDURE29Recommendations29Antibiotic Coverage – Not Infected29Antibiotic Coverage – Infected29IPG Explantation2911 INSTRUCTIONS FOR PATIENTS3012 EMERGENCY PERSONNEL INFORMATION31Radiopaque Identifier31ECG Artifact31Temporarily Inhibiting the IPG Output3113 TROUBLESHOOTING32CVRx Contact Information32Programmer System and Warning messages3214 WARRANTY / DISCLAIMER OF WARRANTY3315 REGULATORY NOTICES3416 SPECIFICATIONS OF NONIMPLANTABLE COMPONENTS35Programmer System35Programmer System Components35Computer35Miscellaneous Information3617 SPECIFICATIONS OF IMPLANTABLE COMPONENTS37Pulse Generator37Pulse Generator Parameters3818 ELECTROMAGNETIC COMPATIBILITY DECLARATIONS39Programmer System EMC Precautions39Programmer System RF Specifications3919 R&TTE DECLARATION OF CONFORMITY (DOC)44Tamaño: 800 KBPáginas: 45Language: EnglishManuales abiertas