Related Manuals for BIOTRONIK Edora 8 DR-T
Summarization of Contents
Product Description
Intended Medical Purpose
The purpose of the pacemaker system, including objectives for implantation.
Indications and Contraindications
Details the conditions for which the device is indicated and specific contraindications.
Patient Groups and Clinical Benefits
Defines the target users, patient populations, and clinical advantages provided by the device.
General Safety Instructions
Safe Handling and Warnings
General guidelines and warnings for safe handling and avoiding hazardous situations.
Operating Conditions and Packaging
Details device operating conditions, shipping, storage, and packaging requirements.
Potential Complications and Risks
Details potential medical complications, side effects, and general risks associated with the device.
Technical Failures and Interference
Covers possible technical failures, EMI, and static magnetic field effects.
Implantation
Implantation Procedure and Preparation
Steps for preparing and performing the pacemaker implantation procedure.
Lead Connection and Telemetry Setup
Detailed guide on connecting leads to the device and establishing telemetry.
Programming and Initialization
Covers device auto-initialization and essential programming precautions.
Post-Implantation Follow-up and Patient Care
Procedures for device follow-up and important information for patients.
Parameter Settings
Timing Parameters
Configuration of basic rate, night rate, AV delay, and rate hystereses.
Pacing and Sensing Configuration
Settings for pulse amplitude, width, sensitivity, and capture control.
Rate Adaptation and Modes
Parameters for CLS and accelerometer-based rate adaptation and mode switching.
MRI Program and Value Tolerances
Specific settings for MRI compatibility and acceptable tolerances for device parameters.
Technical Data
Mechanical Characteristics
Physical dimensions, volume, mass, and materials of the device.
Electrical Characteristics
Details on circuit technology, impedance, pulse waveform, and polarity.
Battery Data and Service Life
Information on battery characteristics, capacity, and estimated service times.
Label Icon Explanations
Explanation of icons and symbols used on the device label for identification and compliance.
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