Diabeloop SA DBLG1 - User Manual

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Table of Contents3
Part 1: Getting Started9
About this User Guide9
Introduction to the DBLG1 System9
Intended Purpose10
Indications10
Contraindications10
Safety Statements11
Symbols11
General Safety Statements13
Safety Statements about the Dexcom G615
Safety Statements about the Kaleido Pump18
Safety Statements about the DBLG121
Safety Statements about the Insulin23
System Components24
Composition of the DBLG1 System24
Dexcom G625
Kaleido Insulin Pump25
Dblg129
Data Sharing to Yourloops29
Composition of Your First-Aid Kit30
Traveling with Your DBLG1 System30
When Flying31
Data Transfer to Yourloops31
Part 2: Using Your System32
DBLG1: First-Time Use32
Installing the Battery and Charging the DBLG132
Turning the DBLG1 on32
PIN Code33
Initialization Procedure33
Main Menu39
Setting up the Glucose Sensor40
Entering the Sensor Code40
Using the Applicator to Insert the Built-In Sensor41
Attaching the Transmitter42
Pairing the Transmitter and Starting the Sensor Session43
Calibrating Your Dexcom G6 (Optional)44
Checking the Status of the Sensor46
Stopping the Sensor Session47
Removing the Sensor48
Reusing Your Transmitter and Restarting a Sensor Session48
Changing the Transmitter49
Setting up the Insulin Pump49
Setting up the Kaleido Insulin Pump49
Filling Your Insulin Cartridge49
Inserting the Cartridge into the Pump54
Choosing Your Infusion Site55
Inserting the Infusion Set under Your Skin56
Connecting Your Pump to the Infusion Set60
Pairing the Kaleido Pump and the DBLG163
Checking the Status of Your Insulin Pump67
Managing Loop Mode69
Starting Loop Mode69
Checking the Status of Loop Mode70
Stopping Loop Mode70
Using Your Pump in Daily Life70
Controlling the Pump Manually70
Stopping and Restarting Insulin Delivery72
Removing the Pump to Switch to Another Pump72
Removing the Pump Temporarily74
Charging Your Pump75
Declaring an External Bolus on the DBLG176
Unpairing the Pump77
Information Displayed on the DBLG177
DBLG1 Home Screen77
Lock Screen of DBLG179
Trend Arrows of the Dexcom G6 Sensor79
Meals79
Declaring a Meal79
Meal Bolus Recommendations80
Modifying or Deleting a Meal81
Physical Activities82
Declaring a Physical Activity83
Modifying or Deleting a Physical Activity83
Stopping an Ongoing Physical Activity84
Rescue Carb Intake85
Rescue Carb Recommendations85
Entering a Rescue Carb Intake Manually85
History86
History Graph86
Detailed History of the Bolus Doses87
Detailed History of the Calibrations88
Statistics88
About Your Diabeloop Application88
Part 3: System Settings and Customization89
Medical Settings89
Thresholds89
Loop Mode Settings90
Loop Mode off Settings91
Patient Settings92
Zen Mode Settings93
DBLG1 Settings93
Sound and Vibration Settings (Alerting You to a Risk)93
Credentials96
Data Sharing98
Language98
Preferences98
Time98
Updates98
Part 4: Warranty, Maintenance and Disposal100
Warranty100
What Is Covered and for How Long100
What Is Not Covered100
Obligations of Diabeloop SA under this Limited Warranty100
Cleaning and Storage101
Dexcom G6101
Kaleido Insulin Pump102
Dblg1103
Disposal and Waste Management104
Dexcom G6104
Kaleido Insulin Pump105
Dblg1105
Part 5: Alarm System and Troubleshooting106
Alarm System106
Classification of the Alarm System107
Testing the Alarm System107
Symbols Associated with the Alarm System107
List of Alarms and Alerts108
Troubleshooting124
Dexcom G6124
Part 6: Technical Specifications126
Medical Device and General Information126
Essential Performance126
Service Life of the Components126
Potential Risks127
Dexcom G6128
Performance Characteristics Summary128
Technical Specifications of the Product129
Electromagnetic Immunity and Emissions: Declaration and Guidance130
Radio Regulations Compliance131
Kaleido Insulin Pump131
Technical Specifications131
Electromagnetic Immunity and Emissions: Declaration and Guidance133
Manufacturer's Declarations and Statements138
Dblg1139
Expected Effects of the DBLG1 System139
Technical Specifications of the Handset139
Frequency Bands and Maximum Radio Frequency Power140
Electromagnetic Immunity and Emissions: Declaration and Guidance141
Manufacturer's Declarations and Statements142

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Diabeloop SA DBLG1 Specifications

General

Brand	Diabeloop SA
Model	DBLG1
Category	Medical Equipment
Language	English

Diabeloop SA DBLG1 - User Manual

Table of Contents

Diabeloop SA DBLG1 Specifications