System User Guide
315 Pages
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MiniMed® 630G System User Guide
MiniMed® 630G System User Guide
Copyright & trademarks ©2016 Medtronic MiniMed, Inc. All rights reserved. CareLink®, Guardian®, Bolus Wizard®, Enlite®, MiniLink®, Dual Wave®, Square Wave®, and MiniMed® are registered trademarks of Medtronic MiniMed, Inc. Easy Bolus™ and SmartGuard™ are trademarks of Medtronic MiniMed, Inc. Bayer® and CONTOUR® are registered trademarks of Bayer. Humalog® is a registered trademark of Eli Lilly and Company. NovoLog® is a registered trademark of Novo Nordisk A/S.
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Contacts: Africa: Medtronic Africa (Pty) Ltd. Tel: +27 (0) 11 677 4800 Argentina: Corpomedica S.A. Tel: +(11) 4 814 1333 Medtronic Directo 24/7: +0800 333 0752
Colombia: Medtronic Latin America Inc. Sucursal Colombia Tel: +(1) 742 7300 Medtronic Directo 24/7 (Landline): +01 800 710 2170 Medtronic Directo 24/7 (Cellular): +1 381 4902
Australia: Medtronic Australasia Pty. Ltd. Tel: 1800 668 670
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Azerbaijan: Isomed Tel: +994 (12) 464 11 30
Danmark: Medtronic Danmark A/S Tel: +45 32 48 18 00
Bangladesh: Sonargaon Healthcare Pvt Ltd. Mobile: (+91)-9903995417 or (+880)-1714217131
Deutschland: Medtronic GmbH Geschäftsbereich Diabetes Telefon: +49 2159 8149-370 Telefax: +49 2159 8149-110 24-Stdn-Hotline: 0800 6464633
Belarus: ОДО “Баджин” Tel: +375 17 313 0990 België/Belgique: N.V. Medtronic Belgium S.A. Tel: 0800-90805 Bosnia and Herzegovina: Medimpex d.o.o. Tel: +387 33 476 444 or +387 33 476 400 Fax: +387 33 476 401 or +387 33 432 241 Brasil: Medtronic Comercial Ltda. Tel: +(11) 2182-9200 Medtronic Directo 24/7: +0800 773 9200 Bulgaria: RSR Ltd. Tel: +359 885 428 900 Canada: Medtronic of Canada Ltd. Tel: 1-800-284-4416 (toll free/sansfrais) Chile: Medtronic Chile Tel: +(9) 66 29 7126 Medtronic Directo 24/7: +1 230 020 9750 Medtronic Directo 24/7 (From Santiago): +(2) 595 2942 China: Medtronic (Shanghai) Ltd. 24 Hour Help (Cell): +86 400-820-1981 24 Hour Help (Landline): +86 800-820-1981
Eire: Accu-Science LTD. Tel: +353 45 433000 España: Medtronic Ibérica S.A. Tel: +34 91 625 05 42 Fax: +34 91 625 03 90 24 horas: +34 900 120 330 Europe: Medtronic Europe S.A. Europe, Middle East and Africa Headquarters Tel: +41 (0) 21-802-7000 France: Medtronic France S.A.S. Tel: +33 (0) 1 55 38 17 00 Hellas: Medtronic Hellas S.A. Tel: +30 210677-9099 Hong Kong: Medtronic International Ltd. Tel: +852 2919-1300 To order supplies: +852 2919-1322 24-hour helpline: +852 2919-6441 India: India Medtronic Pvt. Ltd Tel: (+91)-80-22112245 / 32972359 Mobile: (+91)-9611633007 Indonesia: Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000 Israel: Medtronic World Trade Corporation Tel: +972 9972 4400
Italia: Medtronic Italia S.p.A. Tel: +39 02 24137 261 Fax: +39 02 24138 210 Servizio assistenza tecnica: Nº verde: 800 60 11 22 Japan: Medtronic Japan Co. Ltd. Tel: +81-3-6776-0019 24 Hr. Support Line: 0120-56-32-56 Kazakhstan: Medtronic BV in Kazakhstan Tel: +7 727 311 05 80 (Almaty) Tel: +7 717 224 48 11 (Astana) Круглосуточная линия поддержки: 8 800 080 5001 Latin America: Medtronic, Inc. Tel: 1(305) 500-9328 Fax: 1(786) 709-4244 Latvija: Ravemma Ltd. Tel: +371 7273780 Macedonia: Alkaloid Kons Dooel Tel: +389 2 3204 430 Magyarország: Medtronic Hungária Kft. Tel: +36 1 889 0688 Malaysia: Medtronic International Ltd. Tel: +603 7946 9000 Middle East and North Africa: Regional Office Tel: +961-1-370 670 Montenegro: Glosarij Tel: +382 20 642 495 Fax: +382 20 642 540 México: Medtronic Servicios S. de R. L. de C.V. Tel (México DF): +(11) 029 058 Tel (Interior): +01 800 000 7867 Medtronic Directo 24/7 (from México DF): +(55) 36 869 787 Medtronic Directo 24/7: +01 800 681 1845 Nederland, Luxembourg: Medtronic B.V. Tel: +31 (0) 45-566-8291 Gratis: 0800-3422338 New Zealand: Medica Pacifica Phone: 64 9 414 0318 Free Phone: 0800 106 100
Norge: Medtronic Norge A/S Tel: +47 67 10 32 00 Fax: +47 67 10 32 10
Taiwan: Medtronic (Taiwan) Ltd. Tel: 02-21836000 Toll free: +886-800-005285
Philippines: Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000
Thailand: Medtronic (Thailand) Ltd. Tel: +662 232 7400
Poccия: ООО «Медтроник» Tel: +7 495 580 73 77 Круглосуточная линия поддержки: 8 800 200 76 36 Polska: Medtronic Poland Sp. z o.o. Tel: +48 22 465 6934 Portugal: Medtronic Portugal Lda Tel: +351 21 7245100 Fax: +351 21 7245199 Puerto Rico: Medtronic Puerto Rico Tel: 787-753-5270 Republic of Korea: Medtronic Korea, Co., Ltd. Tel: +82.2.3404.3600 Romania: Medtronic BV Reprezentanta Tel: +40 372 188 000 Schweiz: Medtronic (Schweiz) AG Tel: +41 (0)31 868 0160 24-Stunden-Hotline: 0800 633333 Fax Allgemein: +41 (0)318680199 Serbia: Medtronic B.V. Serbia Tel: +381 11 2095 900 Singapore: Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000 Slovenija: Zaloker & Zaloker d.o.o. brezplačna številka: 080 1880 Tel: +386 1 542 51 11 Slovenská republika: Medtronic Slovakia, s.r.o. Tel: +421 26820 6942 HelpLine: +421 26820 6986 Sri Lanka: Swiss Biogenics Ltd. Mobile: (+91)-9003077499 or (+94)-777256760 Suomi: Medtronic Finland Oy Tel: +358 20 7281 200 Help line: +358 400 100 313 Sverige: Medtronic AB Tel: +46 8 568 585 20 Fax: +46 8 568 585 11
Türkiye: Medtronic Medikal Teknoloji Ticaret Ltd. Sirketi. Tel: +90 216 4694330 USA: Medtronic Diabetes Global Headquarters 24 Hour HelpLine: +1-800-646-4633 To order supplies: +1-800-843-6687 Ukraine: Medtronic B.V. Representative office in Ukraine Tel: +38 044 392 04 01 Лінія цілодобової підтримки: 0 800 508 300 United Kingdom: Medtronic Ltd. Tel: +44 1923-205167 Österreich: Medtronic Österreich GmbH Tel: +43 (0) 1 240 44-0 24 – Stunden – Hotline: 0820 820 190 Česká republika: Medtronic Czechia s.r.o. Tel: +420 233 059 111 Non-stop helpLine (24/7): +420 233 059 059 Zákaznický servis (8:00 - 17:00): +420 233 059 950
WARNING: The SmartGuard Suspend on low feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the SmartGuard Suspend on low feature, it is important to read the SmartGuard Suspend on low information in the Getting Started Guide and the MiniMed 630G System User Guide and discuss proper use of the SmartGuard Suspend on low feature with your healthcare provider.
Warranty The expected life of the MiniMed insulin pump is a maximum of 4 years. Medtronic Diabetes warrants the MiniMed insulin pump against defects in materials and workmanship for a period of 4 years from the date of purchase. During the warranty period, Medtronic Diabetes will, at its discretion, replace (with a new or recertified pump, at Medtronic Diabetes’ discretion) any defective pump or motor, subject to the conditions and exclusions stated herein. In the event that a pump replaced, the warranty period will not be extended. This warranty is valid only if the MiniMed insulin pump is used in accordance with the manufacturer’s instructions. This warranty will not apply: •
If damage results from changes or modifications made to the pump by the user or third persons after the date of manufacture.
•
If damage results from use of non-Medtronic reservoirs and/or infusion sets.
•
If damage results from service or repairs performed by any person or entity other than the manufacturer.
•
If damage results from a Force Majeure or other event beyond the control of the manufacturer.
•
If damage results from negligence or improper use, including but not limited to: improper storage or physical abuse, such as dropping or otherwise.
This warranty shall be personal to the original user. Any sale, rental or other transfer or use of the product covered by this warranty to or by a user other than the original user shall cause this warranty to immediately terminate. This warranty does not apply to batteries, infusion sets, reservoirs, and other accessories. The remedies provided for in this warranty are the exclusive remedies available for any breach hereof. Neither Medtronic Diabetes nor its suppliers or distributors shall be liable for any incidental, consequential, or special damage of any nature or kind caused by or arising out of a defect in the product. All other warranties, expressed or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose.
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Contents Before you begin 3
Using this user guide
4
Assistance
4
Emergency kit
5
Medical Emergency card and travel information
6
User safety
6
Indications
7
Contraindications
7
Potential risks
10
Benefits
11
General warnings
15
General precautions
17
Adverse reactions
17
Notice
19
Keeping track of your system information
19
Insulin guidelines
20
Consumables
21
Additional 630G system devices
21
Accessories
22
Ordering supplies and accessories
First steps 25
Your pump Contents
vii
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26
Using the buttons
27
About batteries
28
Inserting the battery
29
Removing the battery
30
Getting to know your pump
30
Entering your startup settings
32
Unlocking your pump
33
Home screen
35
Status bar
37
Status screens
39
Using the Menu screen
40
Scroll bar
40
Power modes
41
If you remove your pump
Basal
viii
45
Basal rate
46
Basal insulin settings
47
Max Basal Rate
47
Example 1: Max basal
47
Example 2: Max basal
48
Basal patterns
48
Adding a new basal pattern
52
Editing, copying, or deleting a basal pattern
52
Changing from one basal pattern to another
53
Example 1: Basal patterns
53
Example 2: Basal patterns
54
Temporary basal rates
54
About Temp Basal rates
55
Starting a Temp Basal rate
56
Preset Temp basal rates
59
Canceling a Temp Basal or Preset Temp basal rate Contents
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59
Viewing your basal information
61
Stopping and resuming your insulin delivery
Bolus About bolus deliveries
65
Bolus types
66
Bolus type example
67
Bolus delivery options
68
Bolus settings
69
Max Bolus
70
Example 1: Max bolus
70
Example 2: Max bolus
70
Bolus Increment
71
Bolus Speed
71
Bolus Wizard
71
Understanding your Bolus Wizard settings
72
Setting up the Bolus Wizard feature
75
Changing your Bolus Wizard settings
77
Turning off the Bolus Wizard feature
78
About active insulin
78
Bolus Wizard warnings
79
Normal bolus
79
Delivering a Normal bolus with the Bolus Wizard
81
Delivering a Normal bolus using Manual Bolus
82
Square Wave bolus
83
Turning on or off Square Wave bolus
83
Delivering a Square Wave bolus with the Bolus Wizard
84
Delivering a Square Wave bolus using Manual Bolus
85
Dual Wave bolus
85
Turning on or off Dual Wave bolus
86
Delivering a Dual Wave bolus with the Bolus Wizard
87
Delivering a Dual Wave Bolus using Manual Bolus
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65
Contents
ix
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88
Easy Bolus
89
Understanding Easy Bolus step sizes
89
Setting up Easy Bolus
90
Delivering a bolus using Easy Bolus
91
Preset Bolus
91
Setting up and managing Preset Bolus deliveries
93
Delivering a Preset Bolus
94
Stopping a bolus delivery
Reservoir and infusion set 99
Setting up the reservoir and infusion set
112
Disconnecting and reconnecting your infusion set
Meter 117
About your compatible Bayer meter
118
Wirelessly connecting your pump and meter
118
Setting up Remote Bolus
118
Deleting a meter from your pump
History and events 123
History
123
Summary screen
124
Understanding the Summary screen
127
Daily History
128
Alarm History
128
Using Sensor Glucose Review
130
ISIG History
130
Event Markers
Reminders
x
135
Personal reminders
136
Bolus BG Check reminder
Contents
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Missed Meal Bolus reminder
138
Low Reservoir reminder
139
Set Change reminder
139
Calibration reminders
General settings 143
Airplane Mode
144
Audio Options
145
Auto Suspend
145
Block Mode
147
Carb Unit
147
Display Options
148
Language
148
Managing your pump settings
152
Self Test
153
Sensor Demo
154
Time and date
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137
Setting up Continuous Glucose Monitoring 157
Understanding Continuous Glucose Monitoring (CGM)
158
Home screen with CGM
161
Understanding glucose settings
161
High settings
162
Low settings
170
Turning on the Sensor feature
170
Setting up the High Settings
174
Setting up the Low Settings
177
Manually resuming basal delivery during a SmartGuard Suspend on low event
177
Wirelessly connecting your pump and transmitter using Auto Connect
181
Wirelessly connecting your pump and transmitter using Manual Connect
184
Deleting the transmitter from your pump
Contents
xi
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184
Inserting the sensor
184
Connecting the transmitter to the sensor
184
Starting the sensor
186
Calibrating your sensor
187
Where to enter your calibration BG meter reading
188
When to calibrate
188
Guidelines for calibrating
189
Disconnecting the transmitter from the sensor
189
Removing the sensor
189
Turning off Sensor Settings
Using continuous glucose monitoring 193
The sensor graph
194
Identifying rapid changes in sensor glucose
195
Silencing Glucose Alerts
Alarms, alerts, and messages 201
About alarms, alerts, and messages
202
Alarms
203
Alerts
204
Messages
204
Pump alarms, alerts, and messages
217
CGM (sensor) alarms, alerts, and messages
225
CareLink alert and message
Troubleshooting
xii
229
Troubleshooting pump issues
230
What is a Check Settings alarm?
230
My pump is asking me to rewind
230
I dropped my pump
231
I cannot get to the Manage Settings screen
231
My pump display times out too quickly
Contents
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Where is my pump status screen?
232
My pump is asking me to enter my settings
234
Troubleshooting sensor issues
234
My pump cannot find the sensor signal
236
Calibration not accepted
236
Why does the SmartGuard shield on my Home screen appear gray?
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231
Maintenance 241
Cleaning your pump
242
Cleaning your transmitter
242
Storing your pump
243
Storing your transmitter
Product specifications and safety information 247
Product specifications
247
Alarm and alert escalation
248
Altitude range
248
Audio frequency
249
Backlight
249
Basal delivery
250
BG Target
250
BG meter value
250
Bolus delivery
251
Bolus Wizard feature default settings
251
Bolus Wizard feature specifications
254
Carb ratios
254
Delivery accuracy
255
Easy Bolus
256
Environmental conditions
256
Essential performance
256
Filling the infusion set and cannula
256
Infusion pressure
Contents
xiii
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257
Insulin delivery default settings
258
Insulin sensitivity factor
258
Low Reservoir reminder
258
Max Bolus
258
Normal bolus
259
Occlusion detection
259
Percent temp basal
259
Program safety checks
259
Pump dimensions
260
Pump memory
260
Pump weight
260
Sensor default settings
262
Guidance and manufacturer's declaration
267
Wireless communication
267
Quality of service
268
Radio frequency (RF) communications specifications
268
Data security
269
Icon table
Appendix A: End user software license agreement 273
End user software license agreement
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Glossary
■
Index
xiv
Contents
before you begin
This user guide is designed to help you understand the operation of your MiniMed® 630G system with SmartGuard™ technology. SmartGuard can temporarily suspend insulin delivery based on your sensor glucose values. Work closely with your healthcare professional when starting insulin pump therapy.
Using this user guide This user guide contains valuable information about using your new insulin pump. To help you find the information you need, you can use the table of contents at the beginning of the user guide and the index at the end of the user guide. There is also a glossary of terms, which starts on page 277. The following table describes certain terms, conventions, and concepts used in this user guide. Convention
What it means
Select
To activate a screen item, accept a value, or initiate an action.
Select and hold
To perform an action using your pump screen, press the Select button and hold until the action is complete.
Press
To push and then release a button.
Press and hold
To push and keep pressure on a button.
Bold text
To indicate screen items and buttons. For example, "Select Next to continue."
Before you begin
3
■ before you begin
Before you begin
Convention Note
What it means
Note: A note provides helpful information.
Caution
Caution: A caution notifies you of a potential hazard which, if not avoided, may result in minor or moderate injury or damage to the equipment.
WARNING
WARNING: A warning notifies you of a potential hazard which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards.
Assistance Department
Telephone number
24 Hour HelpLine (calls within the United States)
800 646 4633
24 Hour HelpLine (calls outside the United States)
+1 818 576 5555
Web site
www.medtronicdiabetes.com
Emergency kit Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Tell a family member, co-worker, or friend where you keep your emergency kit. It is important that you test your blood glucose (BG) more frequently while you are traveling. The routine hassle of travel, including stress, changes in time zones, schedules and activity levels, meal times and types of food, can all affect your diabetes control. Be extra attentive to monitoring your BG frequently, and be prepared to respond if needed. Your emergency kit should include these items:
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Chapter 1
Fast-acting glucose tablets.
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Blood glucose monitoring supplies.
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Urine or blood ketone monitoring supplies.
•
Extra MiniMed infusion set and MiniMed reservoir.
•
Extra new AA lithium or alkaline batteries, or fully charged NiMH batteries.
•
Insulin syringe and fast-acting insulin (with dosage instructions from your healthcare professional).
•
Medical Emergency card (packaged with your pump accessories).
•
Adhesive dressing.
•
Glucagon emergency kit.
■ before you begin
•
WARNING: Do not use the Bolus Wizard® to calculate a bolus for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in the active insulin amount. Therefore, the Bolus Wizard could prompt you to deliver more insulin than needed. Too much insulin can cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you can rely on the active insulin calculation of your Bolus Wizard.
WARNING: Do not insert the reservoir into your pump until you have been instructed to do so by your healthcare professional, and have received formal training with a certified product trainer. Attempting to use insulin in your pump before you have received training may result in the delivery of too little or too much insulin, which can cause hyperglycemia or hypoglycemia.
For details on pump safety, see User safety, on page 6.
Medical Emergency card and travel information Your pump accessories are packaged with a Medical Emergency card that you should complete and carry with you at all times, especially when traveling.
Before you begin
5
It is important that you test your blood glucose (BG) more frequently while you are traveling. The routine hassle of travel, including stress, changes in time zones, schedules and activity levels, meal times and types of food, can all affect your diabetes control. Be extra attentive to monitoring your BG frequently, and be prepared to respond if needed.
User safety Indications MiniMed® 630G system with SmartGuard™ The MiniMed 630G system with SmartGuard is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 630G system includes SmartGuard, which can be programmed to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value. The MiniMed 630G system consists of the following devices: MiniMed 630G Insulin Pump, Enlite® Sensor, one–press serter, the Guardian® Link transmitter system, CareLink® USB, Bayer’s CONTOUR® NEXT LINK 2.4 Wireless Meter, and Bayer’s CONTOUR® NEXT Test Strips. The system requires a prescription. The MiniMed 630G system is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 630G system. The MiniMed 630G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the SmartGuard Suspend on low alarm to take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.
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Chapter 1