The BIOMONITOR III system consists of three main components: 1. In addition, the BIOMONITOR III can be activated by the patient to record cardiac rhythm during symptomatic episodes. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, asystole, sudden rate drop, or high ventricular rate. The BIOMONITOR III is designed to automatically record the occurrence of arrhythmias in a patient. (or properly licensed practitioner) BIOTRONIK, Inc., All rights reserved.ģ Contents Chapter 1: Device Description 1 Chapter 2: Indications 3 Chapter 3: Contraindications 5 Chapter 4: Warnings and Precautions MRI SAFETY INFORMATION Patient Pre-MRI Conditions MRI Scanner Limitations Restrictions during the MR Scan Implanted Pacemakers and Defibrillators Medical Therapy Storage and Handling Home Monitoring Electromagnetic Interference (EMI) Home and Occupational Environments Cellular Phones Hospital and Medical Environments Insertable Cardiac Monitor Explant and Disposal 12 Chapter 5: Programmable Parameters Parameters ProgramConsult Atrial Fibrillation (AF) High Ventricular Rate (HVR) Bradycardia Sudden Rate Drop (SRD) Asystole Duration Patient Trigger Resting Rate Period 23Ĥ 5.2 Home Monitoring (HM) HM PID Home Monitoring Time of Transmission Periodic Subcutaneous Electrocardiogram (secg) Last Message Episode Recording/Transmission Patient Data ID First / Last Name Date of Birth Gender Date of Implant Hospital, City Physician NYHA Symptom Etiology Remark Sensitivity Settings SensingConsult Sensing High Pass Filter Input Signal Polarity Input High-Pass Filter 30 Chapter 6: Diagnostics Diagnostics Overview General Statistical Information Activity Rate Trends Rate Histogram Activity Trend AF Details AF Trends AF Time of Occurrence AF Duration Ventricular Rate During AF 35ĥ 6.5 Sensing R-wave Trend Noise Duration Trend 36 Chapter 7: Other Functions/Features Home Monitoring Transmission of Information Patient Data Transmitting Data Types of Report Transmissions Description of Transmitted Data Patient Data Memory Position Indicator 40 Chapter 8: Product Storage and Handling Sterilization and Storage 41 Chapter 9: Follow-up Procedures General Considerations Real-time secg Transmission Follow-up Page Recordings secg Atrial Fibrillation High Ventricular Rate Bradycardia Asystole Patient Trigger 46 Chapter 10: Elective Replacement Indication (ERI) 47 Chapter 11: Insertion/Removal Opening the Sterile Container 49Ħ 11.2 Insertion Removal Reasons to Remove an Insertable Monitor 52 Chapter 12: Remote Assistant III General Information on the Remote Assistant III Remote Assistant III Functional Testing Getting to Know the Remote Assistant III Triggering a Manual Recording Battery LED Indicator Explained Signal Transmission LED Explained 54 Chapter 13: Technical Data Parameters Atrial Fibrillation High Ventricular Rate Bradycardia Sudden Rate Drop (SRD) Asystole Duration Patient Trigger Resting Rate Period Home Monitoring Materials in Contact with Human Tissue Electrical Data/Battery Mechanical Data 57 Chapter 14: AF Detection Study Results BioMonitor 2 Pilot Study Results BioInsight Study Results 60 Chapter 15: Order Information 61ħ Chapter 1 Chapter 1: Device Description BIOMONITOR III is a programmable, subcutaneous insertable monitor able to record subcutaneous ECGs (secgs) and other physiological parameters. 2 BIOMONITOR III Technical Manual BIOMONITOR III Insertable Monitor BIOMONITOR III X-Ray identification Radiopaque Identification A radiopaque identification code is visible on standard X-ray, and identifies the insertable monitor: BIOMONITOR III CAUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician.
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