Diabeloop SA DBLG1 Manuals

Manuals and User Guides for Diabeloop SA DBLG1. We have 1 Diabeloop SA DBLG1 manual available for free PDF download: User Manual

Diabeloop SA DBLG1 User Manual (154 pages)

with Kaleido

Brand: Diabeloop SA | Category: Medical Equipment | Size: 3 MB

Table of Contents
3
Part 1: Getting Started
9
About this User Guide
9
Introduction to the DBLG1 System
9
Intended Purpose
10
Indications
10
Contraindications
10
Safety Statements
11
Symbols
11
General Safety Statements
13
Safety Statements about the Dexcom G6
15
Safety Statements about the Kaleido Pump
18
Safety Statements about the DBLG1
21
Safety Statements about the Insulin
23
System Components
24
Composition of the DBLG1 System
24
Dexcom G6
25
Kaleido Insulin Pump
25
Dblg1
29
Data Sharing to Yourloops
29
Composition of Your First-Aid Kit
30
Traveling with Your DBLG1 System
30
When Flying
31
Data Transfer to Yourloops
31
Part 2: Using Your System
32
DBLG1: First-Time Use
32
Installing the Battery and Charging the DBLG1
32
Turning the DBLG1 on
32
PIN Code
33
Initialization Procedure
33
Main Menu
39
Setting up the Glucose Sensor
40
Entering the Sensor Code
40
Using the Applicator to Insert the Built-In Sensor
41
Attaching the Transmitter
42
Pairing the Transmitter and Starting the Sensor Session
43
Calibrating Your Dexcom G6 (Optional)
44
Checking the Status of the Sensor
46
Stopping the Sensor Session
47
Removing the Sensor
48
Reusing Your Transmitter and Restarting a Sensor Session
48
Changing the Transmitter
49
Setting up the Insulin Pump
49
Setting up the Kaleido Insulin Pump
49
Filling Your Insulin Cartridge
49
Inserting the Cartridge into the Pump
54
Choosing Your Infusion Site
55
Inserting the Infusion Set under Your Skin
56
Connecting Your Pump to the Infusion Set
60
Pairing the Kaleido Pump and the DBLG1
63
Checking the Status of Your Insulin Pump
67
Managing Loop Mode
69
Starting Loop Mode
69
Checking the Status of Loop Mode
70
Stopping Loop Mode
70
Using Your Pump in Daily Life
70
Controlling the Pump Manually
70
Stopping and Restarting Insulin Delivery
72
Removing the Pump to Switch to Another Pump
72
Removing the Pump Temporarily
74
Charging Your Pump
75
Declaring an External Bolus on the DBLG1
76
Unpairing the Pump
77
Information Displayed on the DBLG1
77
DBLG1 Home Screen
77
Lock Screen of DBLG1
79
Trend Arrows of the Dexcom G6 Sensor
79
Meals
79
Declaring a Meal
79
Meal Bolus Recommendations
80
Modifying or Deleting a Meal
81
Physical Activities
82
Declaring a Physical Activity
83
Modifying or Deleting a Physical Activity
83
Stopping an Ongoing Physical Activity
84
Rescue Carb Intake
85
Rescue Carb Recommendations
85
Entering a Rescue Carb Intake Manually
85
History
86
History Graph
86
Detailed History of the Bolus Doses
87
Detailed History of the Calibrations
88
Statistics
88
About Your Diabeloop Application
88
Part 3: System Settings and Customization
89
Medical Settings
89
Thresholds
89
Loop Mode Settings
90
Loop Mode off Settings
91
Patient Settings
92
Zen Mode Settings
93
DBLG1 Settings
93
Sound and Vibration Settings (Alerting You to a Risk)
93
Credentials
96
Data Sharing
98
Language
98
Preferences
98
Time
98
Updates
98
Part 4: Warranty, Maintenance and Disposal
100
Warranty
100
What Is Covered and for How Long
100
What Is Not Covered
100
Obligations of Diabeloop SA under this Limited Warranty
100
Cleaning and Storage
101
Dexcom G6
101
Kaleido Insulin Pump
102
Dblg1
103
Disposal and Waste Management
104
Dexcom G6
104
Kaleido Insulin Pump
105
Dblg1
105
Part 5: Alarm System and Troubleshooting
106
Alarm System
106
Classification of the Alarm System
107
Testing the Alarm System
107
Symbols Associated with the Alarm System
107
List of Alarms and Alerts
108
Troubleshooting
124
Dexcom G6
124
Part 6: Technical Specifications
126
Medical Device and General Information
126
Essential Performance
126
Service Life of the Components
126
Potential Risks
127
Dexcom G6
128
Performance Characteristics Summary
128
Technical Specifications of the Product
129
Electromagnetic Immunity and Emissions: Declaration and Guidance
130
Radio Regulations Compliance
131
Kaleido Insulin Pump
131
Technical Specifications
131
Electromagnetic Immunity and Emissions: Declaration and Guidance
133
Manufacturer's Declarations and Statements
138
Dblg1
139
Expected Effects of the DBLG1 System
139
Technical Specifications of the Handset
139
Frequency Bands and Maximum Radio Frequency Power
140
Electromagnetic Immunity and Emissions: Declaration and Guidance
141
Manufacturer's Declarations and Statements
142

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Diabeloop SA DBLG1 User Manual (154 pages)

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