BD Strive Manual de usuario

Customer Care:
1.888.BDCARES
IMPORTANT: It is important to receive training prior to using the
BD Strive™ Insulin Management System. If you have not received
training, call Customer Care at 1.888.BDCARES.
BD Strive™
Insulin Management System (IMS)
User Guide
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2 3
Contents
1 Before you start 8
1.1 About this guide.............................................................................9
1.2 Symbols and terms .......................................................................11
1.3 Important safety information..................................................24
1.4 Indications for use.........................................................................28
1.5 Contraindications ..........................................................................29
2 BD Strive™ System Overview 30
2.1 Introduction.....................................................................................31
2.2 About the IDD ...............................................................................36
2.3 About the Remote.........................................................................43
3 Insulin therapy 46
3.1 Target blood glucose value........................................................47
3.2 Using insulin with BD Strive™....................................................48
3.3 Understanding basal rate ..........................................................51
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4 5
3.4 Understanding Food Doses.......................................................52
4 Getting started 54
4.1 Read before you begin ................................................................55
4.2 Set up Remote ................................................................................57
4.3 About Remote’s screen................................................................69
5 Using BD Strive™ 81
5.1 Prepare BD Strive™ ........................................................................82
5.2 Safety tips when wearing your IDD.......................................115
5.3 Delivering a Food Dose using Remote..................................118
5.4 Delivering a Food Dose using IDD..........................................124
5.5 Canceling a Food Dose................................................................128
5.6 Checking your insertion site regularly ...................................130
5.7 Checking IDD Status....................................................................132
5.8 Replacing an IDD ..........................................................................140
5.9 Viewing dose history....................................................................147
5.10 Changing basal insulin rate....................................................153
5.11 Changing IDD button insulin amount...............................158
5.12 Changing date.............................................................................163
5.13 Changing time.............................................................................166
5.14 Changing language...................................................................169
5.15 Changing Remote name .........................................................172
5.16 About Remote..............................................................................176
5.17 Pairing Remote with Smartphone........................................180
5.18 Get the most from BD Strive™ ...............................................184
6 Living with Diabetes 190
6.1 Diabetes management...............................................................191
6.2 Hypoglycemia (low blood sugar)............................................193
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6 7
6.3 Hyperglycemia (high blood sugar).........................................201
6.4 Diabetic Ketoacidosis (DKA) .....................................................204
6.5 Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHS)
......................................................................................................................208
6.6 Preparing for Emergencies.........................................................211
6.7 Exercise / Sports..............................................................................213
6.8 Travel...................................................................................................214
6.9 Sick days............................................................................................217
6.10 Hospitalization and surgeries.................................................221
7 Notifications and Troubleshooting 223
7.1 Remote Screen Notifications ...................................................224
7.2 IDD Status Notifications ............................................................228
7.3 IDD Status Errors ..........................................................................240
7.4 Communication and System Errors .......................................245
7.5 Smartphone Pairing Errors ........................................................255
7.6 Troubleshooting .............................................................................259
8 Appendix 262
8.1 Care and maintenance................................................................263
8.2 Ordering supplies...........................................................................270
8.3 BD Strive™ options and settings ..............................................271
8.4 Technical specifications...............................................................273
8.5 Dose accuracy.................................................................................306
8.6 Glossary .............................................................................................310
8.7 Recycling Information for Remote.........................................332
9 Index 333
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9
1.1 About this guide
8
Customer Care: 1.888.BDCARES
1. Before you start
Customer care information:
Make sure you read and understand this User Guide, and be sure to
retain this User Guide for future reference. Speak to your healthcare
team if you have questions or concerns about using your BD Strive™
Insulin Management System (BD Strive™) correctly.
If you need assistance in setting up, using or maintaining the BD
Strive™, or to report a malfunction or an unexpected event, call
Customer Care at 1-888-BDCARES.
IMPORTANT: It is important to receive training prior
to using the BD Strive™. If you have not been trained on the
system, please call Customer Care.
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1.1 About this guide (continued) 1.1 Symbols and terms
10 11
Healthcare Team: Working with HCP to train
patients
Your Healthcare Team will include:
• Your doctor or Healthcare Provider (HCP)
• Certified Diabetes Educator (CDE)
Your team will help you learn how to use the BD Strive™ system.
They will teach you how to set your:
• Blood glucose target goals
• Insulin doses
In this section:
This section provides information about the symbols you will find
on the device or instructions (such as this User Guide and the Quick
Start Guide). This section also defines terms and abbreviations used
in this User Guide.
1.2 Symbols and terms
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Symbols and terms
12 13
Term Explanation
WARNING Indicates a hazardous situation that, if not
avoided, could result in death or serious injury.
CAUTION Indicates a hazardous situation that, if not
avoided, could result in minor or moderate injury.
IMPORTANT Indicates instructions that are important to
follow to ensure proper use of the system.
Product-specific symbols:
The following are symbols (and what they mean) which might be
on your wireless Remote, Insulin Delivery Device (IDD), and/or its
packaging, you can also refer to: www.bd.com/symbols-glossary for
additional details.
Symbol What it means
%
MR
Catalog Number/ Model Number.
Indicates the manufacturer’s catalog number so that the
medical device can be identified.
%
MR
Batch Code.
Indicates the device’s batch code so that the medical device
can be identified.
Safety-related symbols:
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Symbols and terms
14 15
Symbol What it means
%
MR
Device Serial Number.
Indicates the device’s serial number so that the medical
device can be identified.
%
MR
Use-by date.
Indicates the device’s use-by date so that the medical device
will not be used after the date accompanying the symbol.
%
MR
Date of Manufacture.
Indicates the date on which the device was manufactured.
Symbol What it means
%
MR
Manufacturer.
Indicates the manufacturer of the device.
%
MR
Storage Temperature Limits.
Indicates the temperature limits to which the medical device
can be safely exposed.
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Symbols and terms
16 17
Symbol What it means
%
MR
CE Mark.
Indicates the mandatory conformity mark for products sold
within the European Economic Area.
%
MR
CAUTION: Federal law (United States) restricts
this device to sale by or on the order of a physician.
%
MR
Refer to Manual.
Indicates that the user needs to refer and follow the
instructions in the manual/booklet.
Symbol What it means
%
MR
Do Not Reuse.
Indicates that the device is for single use only and must not
be used more than once.
%
MR
MR Unsafe.
Indicates that the device is known to pose hazards
in all MRI environments.
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Symbols and terms
18 19
Symbol What it means
%
MR
Type BF Medical Device.
Indicates that the device is protected against electric shock.
%
MR
Sterilized Using Ethylene Oxide.
Indicates that the device is provided sterile and has been
sterilized using ethylene oxide.
Symbol What it means
IP22
IP Code (on Remote). Level of ingress protection.
The Remote is protected against solid foreign objects of 12.5
mm diameter and greater and protected against vertically
falling water drops when tilted up to 15 degrees.
IP27
IP Code (on Insulin Delivery Device). Level of
ingress protection.
The IDD is protected against solid foreign objects of 12.5
mm in diameter and greater. It also protects against
vertically falling water drops. The IDD can be immersed in
1m (3.28 ft) of water for 30 minutes.
%
MR
General Warning Sign.
Indicates warnings applicable to this device.
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