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Medtronic Guardian Connect User Manual

Medtronic Guardian Connect
196 pages
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Medtronic Guardian Connect Specifications

General IconGeneral
Device TypeContinuous Glucose Monitoring (CGM) System
ManufacturerMedtronic
Sensor Life7 days
ConnectivityBluetooth
Warm-up Period2 hours
Mobile App CompatibilityiOS and Android
AlertsCustomizable high and low glucose alerts
Water ResistanceWater-resistant (not fully waterproof)
CalibrationRequires fingerstick calibration 2 times in the first 24 hours, then once daily
Data SharingYes (with caregivers and healthcare providers)

Summary

Guardian Connect Transmitter Overview

Transmitter Kit Components

A complete transmitter kit includes the transmitter, two testers, and a charger.

Indications for Use

Transmitter for single or multiple-patient use in Medtronic CGM systems.

Contraindications

Avoid strong magnetic fields (MRI, diathermy).

Warnings

Refer to sensor guide. Choking hazard for small parts.

Safety and Precautions

Precautions

Use specified sensors/testers. Avoid liquids and twisting.

Exposure to Magnetic Fields and Radiation

Avoid exposure of transmitter to MRI, diathermy, or other strong magnetic field devices.

Regulatory and Communication Information

Radio Frequency (RF) Communication

Device complies with FCC Part 15 rules, subject to two conditions for operation.

Directive 1999/5/EC

Medtronic declares product conforms to essential requirements of Directive 1999/5/EC.

EMC Precautions and Assistance

IEC60601-1-2; Special EMC Precautions for Medical Electrical Equipment

Special precautions regarding Electromagnetic Compatibility (EMC) for body worn devices.

Assistance

Contact your local representative for assistance.

Charger Operation

Installing a Battery in the Charger

Step-by-step instructions for installing a battery in the charger.

Transmitter Charging

To Charge the Transmitter

Detailed steps and indicator light meanings for charging the transmitter.

Transmitter Setup and Connection

Pairing Your Transmitter

Refer to system guide for pairing transmitter to mobile device.

Inserting the Sensor

Refer to serter guide for sensor insertion instructions.

Connecting the Transmitter to the Sensor

Before proceeding, have system user guide available. Steps to connect transmitter to sensor.

Transmitter Management and Tester Use

Disconnecting the Transmitter from the Sensor

Before proceeding, have system user guide available. Steps to disconnect transmitter.

Bathing and Swimming

Transmitter and sensor form a waterproof seal up to 2.4m (8ft) for 30 minutes.

Tester Functionality

Tester checks transmitter function and is required for cleaning. Usable for one year.

Tester Inspection and Connection

Inspecting the Transmitter Connector Pins

Example of connector pins. Check for damage or corrosion.

Tester Usage for Testing or Cleaning

Connecting the Tester for Testing or Cleaning

Before proceeding, have system user guide available. Steps to connect tester.

Transmitter Cleaning Procedures

Cleaning the Transmitter

Transmitter for personal or healthcare facility use. Single-patient requires cleaning after each use.

For Single-Patient Use

Always clean transmitter after each use. Materials needed.

Use Life

Transmitter usable up to 122 cycles or one year.

Multiple-Patient Cleaning and Disinfection

For Multiple-Patient Use

In healthcare facilities, clean and disinfect after each use. Follow standard precautions.

Adhesive Residue Removal and Charger Cleaning

Removing Adhesive Residue

Procedure to remove adhesive residue using medical adhesive remover.

To Remove Adhesive Residue

Steps for removing adhesive residue.

Cleaning the Charger

Procedure for general cleaning of the charger. Do not immerse in water.

Troubleshooting

Device Storage, Disposal, and Specifications

Storing the Devices

Store devices in a clean, dry location. Recharge transmitter at least every 60 days.

Disposal

Dispose of the transmitter according to local regulations for battery disposal.

Specifications

Technical specifications for the transmitter and charger.

Wireless Communication and Manufacturer Declarations

Transmitter Wireless Communication

Transmitter and app connect via BLE. Transmitter sends glucose data and alerts.

Data Security

Transmitter accepts RF communications only from recognized devices. Sensitive data is encrypted.

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

Transmitter intended for use in specified electromagnetic environment.

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

Transmitter intended for use in specified electromagnetic environment.

RF Safety Guidelines

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

More details on immunity tests and environmental guidance.

Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Transmitter

Maintain minimum distance between RF equipment and transmitter based on output power.

Table of Symbols

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