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BIOTRONIK CardioMessenger User Manual

BIOTRONIK CardioMessenger
32 pages
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Preliminary
Manual
for
CardioMessenger
FCC ID: QRICM02-1
BIOTRONIK GmbH & Co.
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BIOTRONIK CardioMessenger Specifications

General IconGeneral
CategoryMedical Equipment
DeviceCardioMessenger
ManufacturerBIOTRONIK
CompatibilityBIOTRONIK implantable cardiac devices
Power SourceRechargeable battery
Power SupplyAC adapter
PortabilityPortable
FunctionRemote monitoring of cardiac devices
ConnectivityCellular network

Summary

What is Home Monitoring?

Home Monitoring Function Explained

Explains the BIOTRONIK Home Monitoring function and its purpose.

About This Technical Manual

User Group

Identifies the intended users of the Cardio Messenger manual.

Technical Manual Conventions

Explains symbols like Note, Caution, and Warning used in the manual.

Cardio Messenger Set and Components

Included Components

Lists the items included in the Cardio Messenger set and accessories.

Safety Precautions - General Warnings

General Safety Warnings

Provides essential safety guidelines for using the Cardio Messenger.

Device Placement and Environmental Protection

Advises on safe placement and protecting the device from environmental factors.

Safety Precautions - Handling and Usage

Environmental and Handling Precautions

Details environmental limits, antenna care, and proper handling of the device.

Disposal and Data Port Safety

Provides guidance on proper disposal and data port safety.

Safety Precautions - EAS Systems

Electronic Article Surveillance Systems

Advises on potential interactions with EAS systems and how to behave around them.

How to Use the Cardio Messenger - Preparation

Preparation and Placement

Details steps and considerations before operating and optimal placement of the Cardio Messenger.

Cardio Messenger Operation - Connections and Lights

Connecting the Charging Station

Explains how to connect the Cardio Messenger to the power supply and charging station.

Understanding the "Traffic Light" System

Describes the meaning of the different lights on the Cardio Messenger.

Cardio Messenger Operation - Indicators and Power

Interpreting Light Indicators

Details the specific meanings of the yellow and green "traffic light" indicators.

Battery Monitor Light States

Explains the different states of the battery monitor light.

Turning On the Cardio Messenger

Provides step-by-step instructions for powering on the Cardio Messenger.

Cardio Messenger Operation - Power Management

Turning Off the Cardio Messenger

Explains how to safely switch off the Cardio Messenger.

Charging the Cardio Messenger

Details the process of charging the Cardio Messenger and interpreting charging status lights.

Cardio Messenger Operation - Status and Troubleshooting Intro

Low Battery and Data Transmission Status

Explains low battery indication and how to know when data is being transmitted.

Introduction to Troubleshooting

Introduces the troubleshooting section for common issues.

Cardio Messenger Troubleshooting - Lights and Reset

Troubleshooting Traffic Light Indicators

Explains troubleshooting steps related to the "traffic light" indicators.

Resetting the Cardio Messenger

Provides instructions on how to reset the device using the reset button.

Cardio Messenger Troubleshooting - Potential Defects

Identifying Potential Defects

Indicates when the Cardio Messenger might be defective and advises consulting a physician.

Implant Data Transmission

Implant Data Transmission Triggers

Explains when the implant automatically sends data or can be triggered.

Warning: Magnets and ICDs

Warns ICD patients against using magnets due to interference risks.

Cardio Messenger Care and Maintenance

Device Care and Inspection

Provides guidelines for keeping the device clean, protected, and for pre-use inspection.

Battery Lifespan and Replacement

Discusses battery life, charging cycles, and when to seek battery replacement.

Cardio Messenger Accessories and Wearing

Wearing Options and Clip Usage

Describes various ways to wear the Cardio Messenger and use its clip.

Frequently Asked Questions - Usage and Failure

Forgetting to Recharge and Device Failure

Addresses consequences of not recharging and impact of device failure on the implant.

Portability and Daily Use

Clarifies if the Cardio Messenger can be taken during daily activities like shopping or sports.

Frequently Asked Questions - Travel

Carrying the Cardio Messenger

Discusses ways to carry the device, including belt, bag, or backpack.

Travel Considerations

Provides advice on traveling with the Cardio Messenger, including voltage and network requirements.

Technical Terms and Abbreviations

Key Term Definitions

Defines terms like Cardio Report, GSM, Home Monitoring, BIOTRONIK Service Center, and SMS.

US Regulatory Requirements - FCC Compliance

FCC Compliance and MICS Service

Explains the FCC authorization for the transmitter and MICS service.

FCC ID and Device Standards

States the FCC ID and that the device conforms to government standards.

US Regulatory Requirements - RF Exposure

FCC RF Exposure Guidelines

Discusses the phone's compliance with FCC RF exposure guidelines for body-worn operation.

Legal Considerations - RF Assignment

RF Assignment and Interference Potential

Explains the RF assignment and potential interference issues.

Compliance and Approval Mark

Mentions the device's evaluation by an independent authority and its approval mark.

Legal Considerations - EMC and Warranty

Electromagnetic Compatibility

Explains the device's protection from electromagnetic interference and emissions.

Warranty Terms

Outlines warranty terms related to improper use, storage, or transport.

Technical Data - General and Environmental

General Specifications

Provides general technical specifications like class of protection and operating mode.

Permissible Environmental Conditions

Lists environmental parameters for operation, storage, and shipping.

Cardio Messenger Remote Unit Specs

Details dimensions, weight, charging voltage, and frequency of the remote unit.

Technical Data - Device Components

Charging Station Specifications

Lists dimensions, weight, input/output voltage of the charging station.

Rechargeable Battery Specs

Details the battery model, dimensions, voltage, charge current, and capacity.

Power Supply Specifications

Provides model, dimensions, cable length, and connector type for the power supply.

Appendix - Electromagnetic Interference

Emitted Interference Suitability

Details the Cardio Messenger's suitability for operation in specific electromagnetic environments.

Interference Conformance and Guidelines

Lists conformance levels and guidelines for emitted interference.

Appendix - Electromagnetic Susceptibility

Susceptibility to RF Interference

Details the device's susceptibility to conducted and radiated RF interference.

Interference Environment Guidelines

Provides guidelines for safe distances from portable/mobile radio devices.

Appendix - Electrical Disturbance Susceptibility

Susceptibility to Electrical Disturbances

Covers susceptibility to static discharge, transient disturbances, power surges, and voltage fluctuations.

Magnetic Field Strength Requirements

Specifies requirements for magnetic field strength at supply frequencies.

Appendix - Interference Distance Calculations

Calculating Electromagnetic Interference Distances

Provides calculated safe distances for electromagnetic interference based on transmitter output power.

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