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sorin REPLY DR - User Manual

sorin REPLY DR
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Implant manual Manuel d'implantation
Anwenderhandbuch Manuale d'impianto
Manual de implante
Rate responsive dual-chamber pacemaker
Stimulateur cardiaque double chambre à
fréquence asservie
Frequenzadaptiver Zweikammerschrittmacher
Elettrostimolatore cardiaco bicamerale con
adattamento di frequenza
Marcapasos cardiaco bicameral con
adaptación de frecuencia

Table of Contents

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Summary

General Description

Indications

Contraindications

Generalities

General contraindications for pacemaker use, considering patient condition and age.

Potential Complications

Complications related to the device itself, pacing leads, and medical issues like infection.

Warnings to Patient

Risks Related to Medical Environment

Risks associated with medical treatments like diathermy, defibrillation, radiation, lithotripsy, and ultrasound.

Storage

Characteristics of the Sterile Package

Details on the sterilization process (ethylene oxide) and packaging of the pacemaker and screwdriver.

Implant Procedure

Before Opening the Package

Checks to perform before opening the sterile package, including date verification and device integrity.

Preparing the Pocket

Recommendations for creating the pocket for pacemaker implantation, specifying location and depth.

Choosing the Type of Lead

Guidance on selecting appropriate leads (atrial and ventricular) for optimal pacemaker function and compatibility.

Measurement of Thresholds at Implant

Procedure for measuring pacing and sensing thresholds during the implantation process.

Lead Connection

Step-by-step instructions for correctly connecting the atrial and ventricular leads to the pacemaker ports.

Functioning Test at Implant

Procedure for verifying pacemaker functionality using an ECG immediately after implantation.

Special Modes

Nominal Mode (Emergency Mode)

Description of the nominal mode, also known as emergency mode, for rapid safety function restoration.

Standby Mode

Details on the standby mode, activated during self-test failure, and its operational parameters.

Magnet Mode

Explanation of magnet mode operation, including parameters and behavior when a magnet is applied.

Response in the Presence of Interference

How the pacemaker responds to electrical noise, switching to asynchronous mode at the basic rate.

Functions and Parameters

Pacing Modes

Overview of different pacing modes like DDTA(R), DDTV(R), and DDTAV(R), explaining their functions and indications.

Rates

Details on pacing rates, including basic rate, maximum tracking rate, and rate hysteresis.

Pacing and Sensing Parameters

Parameters related to pacing and sensing, such as pulse amplitude, pulse width, sensitivity, and polarities.

Refractory Periods

Explanation of absolute refractory periods, committed period, automatic AV delay, and AVD Paced/Sensed Offset.

Rate Response

Functionality and parameters of the Rate Response feature, including sensor types and operating modes.

Therapeutic Improvements

Description of therapeutic features like SafeR mode, Dplus mode, Rate acceleration, AV delay shortening, Rest rate, and Rate smoothing.

Managing Atrial Arrhythmias (AA)

Strategies for managing atrial arrhythmias, including Overdrive, Post extrasystolic pause suppression, Acceleration on PAC, and Mode switching.

Optimizing Operation

Methods for optimizing pacemaker operation, including automatic detection of implantation, polarity configuration, and lead impedance measurements.

Patient Follow-up

Follow-up Recommendations

Guidelines for standard and frequent follow-up visits, including battery status checks and device interrogation.

Elective Replacement Indicator (ERI)

Explanation of the Elective Replacement Indicator (ERI) and its control parameters.

Explant

Conditions and procedures for explanting the pacemaker, including end of life and malfunction.

Programmer Tests

Overview of the programmer's capabilities, including impedance tests, threshold tests, and electrophysiologic studies.

Interrogating the Memories (AIDA+)

Information obtained from interrogating device memories, such as battery depletion, statistics, and recorded episodes.

Pacemaker Identification

Methods for identifying the pacemaker model and serial number, using X-ray and the dedicated programmer.

Physical Characteristics

Electrical Characteristics

Current Drain at Beginning of Life

Data on current drain values for different modes and conditions at the beginning of the pacemaker's life.

Correspondence Between Magnet Rate and Battery Impedance

Table showing the relationship between magnet rate and battery impedance values.

Battery

Specifications of the pacemaker battery, including manufacturer, type, model, capacity, and voltage.

Longevity

Estimated longevity of the pacemaker under various shipment and operating conditions.

Programmable Parameters

Non-programmable Parameters

Warranty

Article 1: Terms of Warranty

Details of the warranty terms, including guarantee period, required documentation, and conditions for forfeiture.

Article 2: Terms of Replacement

Conditions for device replacement in case of failure, outlining Sorin CRM's commitment and limitations.

sorin REPLY DR Specifications

General IconGeneral
Brandsorin
ModelREPLY DR
CategoryMedical Equipment
LanguageEnglish

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