Beta Bionics iLet Bionic Pancreas System Manuals

Beta Bionics iLet Bionic Pancreas System Manuals

Manuals and User Guides for Beta Bionics iLet Bionic Pancreas System. We have 1 Beta Bionics iLet Bionic Pancreas System manual available for free PDF download: User Manual

Beta Bionics iLet Bionic Pancreas System User Manual

Beta Bionics iLet Bionic Pancreas System User Manual (71 pages)

Brand: Beta Bionics | Category: Medical Equipment | Size: 2 MB

Table of Contents

Table of Contents
3
Important User Information
4
About this User Guide
4
Indications for Use
5
Insulin Compatibility
6
Working with Your Healthcare Provider
6
Important Pediatric and Caregiver User
6
Information
6
General Warnings and Precautions
7
Potential Risks
9
Compatible Icgms
10
Getting to Know Your Ilet System
11
Ilet System Overview
11
Parts of Your Ilet System
12
Ilet Device
13
Features and Icons
14
Settings Menu
17
History
19
Volume
20
Getting Started with Your Ilet System
20
Preparing to Set up Your Ilet System
21
Setting up Your Ilet System
21
Insulin Set
27
Enter Weight and Go Bionic
28
Living with Your Ilet System
29
What to Expect from Your Ilet
29
Maintaining Your Ilet System
29
When Your CGM Sensor Is Offline
32
Mobile Device
34
Managing Highs and Lows
35
Meal Announcements
37
Exercise
40
Illnesses
41
Responding to Alerts
42
Ilet System Alerts Overview
42
CGM and Glucose Alerts
43
Insulin Delivery Alerts
44
Battery Alerts
44
Reminders
45
Troubleshooting
46
Always Have an Emergency Kit
46
Verify Proper Functionality
46
Care Information
47
General Handling
47
Cleaning Your Ilet Device
47
Clinical Performance
48
Introduction
48
Clinical Study Overview
48
Demographics
49
Primary Endpoints
51
Secondary Endpoints
52
Adverse Effects
54
Intervention Compliance
56
Safety of the Ilet System Using BG Entries Only
56
References
57
Technical Information
57
Ilet Dosing Decision Software
57
Ilet System Specifications (Ilet Device, CGM Sensor, and CGM Transmitter)
59
Ilet Device Specifications
59
Ilet System Delivery Accuracy
61
Explanation of Symbols
63
Electromagnetic Compatibility
64
Electromagnetic Emissions
64
Electromagnetic Immunity
65
Quality of Wireless Service and Data Security
66
FCC Notice Concerning Interference
67
Warranty
68
Ilet Device Warranty
68
Ilet Cartridge Warranty
68
Ilet Infusion Set Warranty
69
Ilet Connect Warranty
69
Returned Goods Warranty
70

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