Medtronic Paradigm Revel User Manual

Page 1
Paradigm® REAL-Time
Revel™ Insulin Pump
User Guide
Page 2
http://www.medtronicdiabetes.com/patents for a listing of patents covering this product. Bolus Wizard
®
, CareLink®, Dual Wave®, Guardian®, Guardian RT®, MiniLink®, Paradigm®, Paradigm Link®, Quick-serter®,
Quick-set
®
,Sen-serter®,Silhouette®,Sof-set®, and Square Wave® are registered trademarks of Medtronic MiniMed, Inc. Easy Bolus™ and Revel™ are trademarks of Medtronic MiniMed, Inc. CONTOUR
®
is a registered trademark of Bayer.
Energizer
®
is a registered trademark of Eveready Battery Company.
Glucagon Emergency Kit
®
is a registered trademark of Eli Lilly and Company.
YSI 2300 STAT Plus™ is a trademark of YSI Inc.
OneTouch
®
, OneTouch® Ultra®, and OneTouch® UltraLink® are registered trademarks of
LifeScan, Inc
.
6025306-018_d
REF MMT-523 MMT-723 MMT-523K MMT-723K
Page 3
Contacts: Africa:
Medtronic Africa (Pty) Ltd. Tel: +27 (0) 11 677 4800
Australia:
Medtronic Australasia Pty. Ltd. Tel: 1800 668 670 (product orders) Tel: 1800 777 808 (customer help)
Azerbaijan:
Albatros Health Care Tel: +994 12 498 9537
Bangladesh
Sonargaon Healthcare Pvt Ltd. Mobile: (+91)-9903995417 or (+880)-1714217131
Belarus:
Badgin Ltd Tel: +375 (172) 665128
België/Belgique:
N.V. Medtronic Belgium S.A. Tel: 0800-90805
Bosnia and Herzegovina
Intermedical Tel: +387 33 202 183 Fax: +387 33 202 183
Brasil:
Medtronic Comercial Ltda. Tel: +(11) 3707-3707
Bulgaria
Interagro-90 Ltd Tel: +359 888 636 033
Canada:
Medtronic of Canada Ltd. Tel: 1-800-284-4416 (toll free/sans­frais)
China:
Medtronic (Shanghai) Ltd. 24 Hour Help (Cell): +86 400-820-1981 24 Hour Help (Landline): +86 800-820-1981
Croatia
Oktal Pharma Tel: +385 1 659 57 77 Fax: +385 1 659 57 01
Croatia
Medtronic B.V. Tel: +385 1 488 11 20 Fax: +385 1 484 40 60
Danmark:
Medtronic Danmark A/S Tel: +45 32 48 18 00
Deutschland:
Medtronic GmbH Geschäftsbereich Diabetes Telefon: +49 2159 8149-370 Telefax: +49 2159 8149-110 24-Stdn-Hotline: 0800 6464633
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: +34 901 120 335
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:
Agentek Tel: +972 3649 3111
Italia:
Medtronic Italia S.p.A. Tel: +39 02 24137 261 Fax: +39 02 24138 210 Servizio assistenza tecnica: Nº verde 24h: 800 712 712
Japan:
Medtronic Japan Co. Ltd. Tel: +81-3-6430-2019
Kazakhstan:
Medtronic Kazakhstan B.V. Tel: +77273110580
Latin America:
Medtronic, Inc. Tel: 1(305) 500-9328 Fax: 1(786) 709-4244
Latvija:
Ravemma Ltd. Tel: +371 7273780
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Macedonia:
Kemofarm Tel: +389 2 260 36 03 Fax: +389 2 260 36 49
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
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
POCCИЯ:
Medtronic B. V. Tel: +7 495 580 73 77 24h: 8-800-200-76-36
Philippines:
Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000
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:
Trustmed SRL Tel: +40 (0) 21 220 6477
Schweiz:
Medtronic (Schweiz) AG Tel: +41 (0)31 868 0160 24-Stunden-Hotline: 0800 633333 Fax Allgemein: +41 (0)318680199
Serbia
Epsilon Tel: +381 11 311 5554 Fax: +381 11 311 5554
Singapore:
Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000
Slovenija:
Zaloker & Zaloker d.o.o. Tel: +386 1 542 51 11 Fax: +386 1 542 43 32
Slovenská republika:
Medtronic Slovakia o.z. Tel: +421 26820 6986 Fax: +421 268 206 999
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 10 Fax: +46 8 568 585 11
Taiwan:
Medtronic-Taiwan Ltd. Tel: +886.2.2183.6068 Toll Free: +886.0800.005.285
Thailand:
Medtronic (Thailand) Ltd. Tel: +662 232 7400
Turkiye:
Medtronic Medikal Teknoloji Ticaret Ltd. Sirketi. Tel: +90 216 4694330
USA:
Medtronic Diabetes Global Headquarters Tel: +1-800-826-2099 24 Hour HelpLine: +1-818-576-5555 To order supplies: +1-800-843-6687
Ukraine:
Med EK Service Ltd. Tel: +380445457705
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
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Česká republika:
Medtronic Czechia s.r.o. Tel: +420 233 059 401 Non-stop help line: +420 233 059 059
Page 6
Page 7
Important Safety Information
Regarding Your Paradigm Insulin Pump
(includes all models)
Avoid Immersing Your Pump In Water
Although it is unlikely that water damage will occur if your pump is splashed or briefly dunked, you should avoid immersing your Paradigm insulin pump in water. To swim or participate in other water activities, always disconnect from your Paradigm pump and reconnect after you are out of the water.
If you inadvertently submerge your pump in water, dry the pump quickly using a soft, clean towel and verify that it is working properly by selecting Selftest from the pump's Utilities Menu. If you believe that water has entered your pump or you observe any other possible pump malfunction, please check your blood glucose, treat high blood glucose (if necessary) with an injection and contact our 24 Hour HelpLine at 1-800-646-4633 for further assistance. Symptoms of high blood glucose include fatigue, excessive thirst and nausea. You should always contact your healthcare professional if you experience excessively high or low blood glucose levels, or if you have any questions about your care.
Electrostatic Discharge
Although your Paradigm pump is designed to be unaffected by typical levels of electrostatic discharge (ESD), very high levels of ESD can result in a reset of the pump's software with an associated pump error alarm. In most cases, exposure to high levels of ESD will trigger the pump's A-13 alarm although, under certain circumstances, high level ESD exposure can cause A-44, Bolus Stopped or Max Delivery alarms. High levels of ESD are more likely in situations where the relative humidity is very low, such as inside a heated building during the winter in areas where it is cold outside.
If your pump experiences an A-13 or other error alarm, press the ESC and ACT buttons to clear the alarm. If you are unable to clear the alarm by pressing ESC and ACT, you may need to remove and replace the pump's battery to clear the alarm. After clearing the alarm, you should always verify that your pump is set to the correct date and time and that all other settings (basal rate, max basal and bolus limits, etc.) are programmed to the desired values, since the software reset could erase your previously programmed settings. Please see the Alarms and Alerts section of this User Guide for more details regarding what to do if your pump displays an error alarm or other alert message.
Please contact our 24 Hour HelpLine at 1-800-646-4633 to report any error alarms or other problems that occur with your pump.
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Warranty
Medtronic Diabetes warrants the Medtronic 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, either repair or 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 is repaired or replaced, the warranty period will not be extended.
This warranty is valid only if the Medtronic 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,
submersion in water 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.
Pumps purchased through our Pathway Program will assume the warranty stated in our Pathway Program agreement.
All other warranties, expressed or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose.
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Contents
Chapter 1: Introduction ..................................................................... 1
Assistance ...................................................................................................... 1
Emergency kit ................................................................................................. 1
Consumables .................................................................................................. 2
Accessories .................................................................................................... 3
How to wear your pump ..................................................................................... 3
How to use this guide ........................................................................................ 4
User safety ..................................................................................................... 5
Indications .................................................................................................. 5
Paradigm REAL-Time Revel insulin pump ............................................................ 5
Meter ...................................................................................................... 5
Contraindications .......................................................................................... 5
Warnings .................................................................................................... 6
Pump ...................................................................................................... 6
Reservoir and infusion sets ............................................................................ 6
Sensor ..................................................................................................... 6
Transmitter .............................................................................................. 6
Magnetic fields .......................................................................................... 6
X-rays, MRIs and CT scans .............................................................................. 7
Precautions ................................................................................................. 7
Avoid extreme temperatures .......................................................................... 7
Infusion sets and sites .................................................................................. 8
Sensor ..................................................................................................... 8
Adverse reactions .......................................................................................... 8
Notice .......................................................................................................... 8
Insulin pump and RF accessories ........................................................................ 8
RF interference from other devices ..................................................................... 9
Contents
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Chapter 2: The basics ...................................................................... 11
Your pump .................................................................................................... 11
Install battery ................................................................................................ 12
Pump buttons ................................................................................................ 13
The pump screen ............................................................................................ 15
HOME screen ................................................................................................. 15
Screen icons ............................................................................................... 15
Battery .................................................................................................. 15
Time display ............................................................................................ 16
Reservoir volume ...................................................................................... 16
Alert and alarm icons ................................................................................. 16
Sensor icons ............................................................................................ 16
Scroll bar .................................................................................................. 17
Screen backlight .......................................................................................... 17
Beep/vibrate ................................................................................................. 17
Operating modes ............................................................................................ 17
Normal mode .............................................................................................. 18
Special mode .............................................................................................. 18
Attention mode ........................................................................................... 18
Menus ......................................................................................................... 19
MAIN MENU ................................................................................................ 19
BOLUS MENU ............................................................................................... 19
SUSPEND ................................................................................................... 19
SENSOR ..................................................................................................... 19
CAPTURE EVENT .......................................................................................... 20
BASAL MENU ............................................................................................... 20
RESERVOIR + SET ......................................................................................... 20
UTILITIES MENU ........................................................................................... 20
STATUS screen ............................................................................................... 20
If you remove your pump .................................................................................. 21
Chapter 3: Basic programming ........................................................... 23
Setting the time and date ................................................................................. 23
Selecting the language ..................................................................................... 25
Bolus .......................................................................................................... 25
Setting the Normal bolus ................................................................................ 26
Normal meal bolus using the exchange system ...................................................... 27
Contents
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Bolus practice: ............................................................................................ 27
Normal meal bolus practice using exchanges ........................................................ 28
Normal meal bolus using carbohydrate counting .................................................... 28
Normal meal bolus practice using carbohydrates ................................................... 29
Meal bolus, correction bolus and insulin sensitivity ................................................ 29
Practice: Meal bolus ..................................................................................... 30
Review your bolus deliveries .............................................................................. 30
Bolus details ............................................................................................... 31
Maximum bolus limit ........................................................................................ 33
Example 1: Max bolus .................................................................................... 33
Example 2: Max bolus .................................................................................... 33
Scroll rate .................................................................................................... 33
Example: Scroll rate ..................................................................................... 34
BG Reminder ................................................................................................. 34
Capturing Events ............................................................................................ 35
Turning on the Capture Event feature ................................................................ 35
Entering BG measurements ............................................................................. 36
Entering insulin injection information ................................................................ 37
Entering carbohydrate information .................................................................... 38
Entering exercise information .......................................................................... 38
Entering Other markers .................................................................................. 39
Viewing Capture Event history ......................................................................... 39
Basal .......................................................................................................... 39
Start and stop times ..................................................................................... 40
Your basal settings ....................................................................................... 41
Basal programming and delivery .................................................................... 41
Current basal delivery ................................................................................... 42
Daily basal rate(s) ........................................................................................ 42
Setting the Max basal rate ................................................................................. 43
Example 1: Max basal .................................................................................... 44
Example 2: Max basal .................................................................................... 44
Stopping your pump ........................................................................................ 44
Resume pump delivery ..................................................................................... 45
Example: Suspend function ............................................................................. 46
Practice: Suspend function ............................................................................. 46
Practice: Resume basal delivery after a suspend ................................................... 47
Contents
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Chapter 4: Starting on insulin ............................................................ 49
Prepare your pump for use ................................................................................ 49
Setting up the reservoir .................................................................................... 50
Filling the reservoir ...................................................................................... 50
Changing your infusion set ................................................................................. 52
Removing the reservoir .................................................................................. 52
Rewinding your pump .................................................................................... 52
Inserting the reservoir in your pump .................................................................. 53
Filling the tubing ......................................................................................... 54
Inserting the infusion set ................................................................................ 55
Quick-set infusion set (with Quick-serter
®
) .......................................................... 57
Filling the cannula ....................................................................................... 57
Disconnecting Quick-set ................................................................................. 59
Reconnecting Quick-set ................................................................................. 59
Record keeping for diabetes management .............................................................. 60
Determining your pump settings .......................................................................... 60
Chapter 5: Using the Bolus Wizard feature ............................................ 63
What is it? .................................................................................................... 63
Carbohydrate counting .................................................................................. 63
Your blood glucose reading ............................................................................. 63
Your personal Bolus Wizard feature settings ......................................................... 63
How the Bolus Wizard feature works ..................................................................... 66
Bolus Wizard warnings ...................................................................................... 67
HIGH BG .................................................................................................... 67
LOW BG .................................................................................................... 67
MAX BOLUS EXCEEDED ................................................................................... 67
How to program the Bolus Wizard feature .............................................................. 67
Turning on the Bolus Wizard feature .................................................................. 68
Selecting the Carb units ................................................................................. 68
Setting the Carb/Exch ratios ........................................................................... 69
Setting the BG units ...................................................................................... 70
Insulin sensitivity ......................................................................................... 70
Setting the BG Targets .................................................................................. 71
About active insulin ...................................................................................... 72
Active insulin time ..................................................................................... 73
Review your Bolus Wizard feature settings ............................................................. 73
Contents
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Page 13
Normal bolus using Bolus Wizard feature ................................................................ 74
Bolus Wizard feature examples ........................................................................... 75
Example 1: Blood glucose on target (normal blood glucose) and no active insulin ............ 76
Example 2: Blood glucose above target (high blood glucose) and no active insulin ........... 77
Example 3: Blood glucose below target (low blood glucose) and no active insulin ............ 78
Example 4: Blood glucose above target (high blood glucose) with active insulin .............. 79
Example 5: Blood glucose below target (low blood glucose) with active insulin ............... 80
Chapter 6: Optimizing pump therapy ................................................... 81
Square Wave and Dual Wave bolus ....................................................................... 81
Turning on the Dual Wave/Square Wave option ..................................................... 82
Square Wave or Dual Wave bolus without Bolus Wizard feature .................................. 82
Square Wave bolus practice ............................................................................ 84
Dual Wave bolus practice ............................................................................... 85
Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus ......................... 85
Easy bolus .................................................................................................... 87
Easy bolus setup .......................................................................................... 87
Step value setup .......................................................................................... 88
Delivering Easy Bolus .................................................................................... 88
Example 1: Easy bolus ................................................................................... 89
Your turn: Easy bolus practice ......................................................................... 90
Missed Bolus Reminder ..................................................................................... 90
Add, delete, and review bolus reminders ............................................................ 90
Add ......................................................................................................... 91
Delete ...................................................................................................... 91
Review ..................................................................................................... 91
Basal patterns ............................................................................................... 91
Turning on the patterns ................................................................................. 92
Programming a pattern .................................................................................. 92
Select a pattern .......................................................................................... 93
Example 1: Basal patterns .............................................................................. 93
Example 2: Basal patterns .............................................................................. 94
Your turn: .................................................................................................. 94
Temp basal rates ............................................................................................ 94
How does temp basal work? ............................................................................ 94
Temp basal types ......................................................................................... 95
Insulin rate (U/H) ...................................................................................... 95
Contents xiii
Page 14
Percent of basal ....................................................................................... 96
Chapter 7: Sensor features .............................................................. 103
Entering your sensor settings ............................................................................ 103
Turning on the sensor .................................................................................. 103
Turning on the Glucose Alerts ........................................................................ 104
Setting the Glucose Limits ............................................................................. 104
Selecting the BG units .................................................................................. 105
Setting the Glucose Limits start time ................................................................ 106
Setting the High Repeat ................................................................................ 107
Setting the Low Repeat ................................................................................ 108
Setting the Predictive glucose alert ................................................................. 108
Setting the Rate of Change Alerts .................................................................... 110
Setting the Cal Repeat ................................................................................. 111
Setting the Cal Reminder .............................................................................. 111
Entering the transmitter ID ............................................................................ 111
Setting up the Weak Signal feature .................................................................. 112
Setting the sensor glucose graph timeout ........................................................... 113
Reviewing your settings ................................................................................ 113
Using the Sensor Demo .............................................................................. 114
The transmitter ............................................................................................ 114
Starting the sensor ........................................................................................ 114
Inserting the sensor ....................................................................................... 115
Removing the sensor ...................................................................................... 115
Preparing the sensor for communication .............................................................. 115
Calibrating the sensor ..................................................................................... 115
Entering meter BG for calibration ...................................................................... 116
Chapter 8: Using your sensor ........................................................... 119
Status screens .............................................................................................. 119
Reading the sensor glucose graphs ...................................................................... 120
Opening and viewing the graphs ...................................................................... 121
The graphs ............................................................................................... 122
Examples of real-time sensor glucose graphs ....................................................... 123
3-hour graph .......................................................................................... 123
6-hour graph .......................................................................................... 124
12-hour graph ......................................................................................... 124
Contents
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24-hour graph ......................................................................................... 125
How to check for rapid changes in sensor glucose ................................................... 126
The rapid change arrows ............................................................................... 126
How to make glucose alerts silent ...................................................................... 127
Calibration history ......................................................................................... 128
Sensor alert history ........................................................................................ 128
Using your system in water ............................................................................... 129
Chapter 9: Utilities ....................................................................... 131
Alarm review ............................................................................................... 131
Setting your alert type .................................................................................... 131
Auto-off ..................................................................................................... 132
LOW RESV WARNING (Low reservoir warning) ......................................................... 132
Review daily insulin totals ............................................................................... 133
Pump data management .................................................................................. 134
Insulin delivery information ........................................................................... 134
Sensor glucose information ............................................................................ 135
Meter blood glucose information ..................................................................... 136
AUC calculation ....................................................................................... 138
Personal reminders ........................................................................................ 140
Alarm clock .............................................................................................. 140
PC connect for change settings .......................................................................... 140
Remote control option .................................................................................... 140
Turn on remote control option ....................................................................... 141
Add, delete, review remote control IDs ............................................................. 141
Other Devices option ...................................................................................... 142
Block feature ............................................................................................... 142
Turning block on ........................................................................................ 142
Example 1: Block ........................................................................................ 142
Example 2: Block ........................................................................................ 143
Lock keypad feature ...................................................................................... 143
Locking the keypad ..................................................................................... 143
Unlocking the keypad .................................................................................. 143
Selftest ...................................................................................................... 143
User settings ................................................................................................ 144
Saving the settings ...................................................................................... 145
Restoring the settings .................................................................................. 145
Contents xv
Page 16
Clearing the settings ................................................................................... 146
History .................................................................................................... 146
Chapter 10: Meter option ............................................................... 147
About meters ............................................................................................... 147
Meter rules ............................................................................................... 147
Add, delete, review meter IDs ........................................................................ 148
Chapter 11: Therapy management software ........................................ 149
CareLink® Personal Software ............................................................................ 149
Reports ................................................................................................... 149
Logbook ................................................................................................... 150
Chapter 12: Insulin pump therapy follow-up ........................................ 151
Recommended follow-up ................................................................................. 151
Everyday .................................................................................................. 151
Every month ............................................................................................. 151
Every three months ..................................................................................... 151
Laboratory tests ......................................................................................... 152
Every visit ................................................................................................ 152
Annually .................................................................................................. 152
Chapter 13: Troubleshooting, alerts and alarms ................................... 153
My pump has a NO DELIVERY alarm ..................................................................... 153
What happens if I leave the pump battery out too long? ............................................ 154
Why doesn't my pump battery last very long? ......................................................... 154
What is a CHECK SETTINGS alarm? ...................................................................... 155
My screen appears distorted ............................................................................. 155
The pump is asking me to rewind ....................................................................... 155
My bolus stopped .......................................................................................... 155
My pump buttons are not acting right during a bolus ................................................ 156
My pump will not display my blood glucose reading from my meter .............................. 156
I dropped my pump ........................................................................................ 156
I submerged my pump in water ......................................................................... 157
I cannot get to the USER SETTINGS screen ............................................................ 157
Alerts ........................................................................................................ 157
Example: ................................................................................................. 158
Contents
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Page 17
What to do ............................................................................................... 158
Pump alert conditions ..................................................................................... 159
LOW RESERVOIR ......................................................................................... 159
LOW BATTERY ........................................................................................... 159
Sensor alert conditions ................................................................................... 159
WEAK SIGNAL ............................................................................................ 159
ALERT SILENCE .......................................................................................... 159
MISSED BOLUS ............................................................................................ 160
LOST SENSOR ............................................................................................ 160
LOW TRANSMTR ......................................................................................... 160
CHARGE TRANSMTR ..................................................................................... 161
CHANGE SENSOR ......................................................................................... 161
SENSOR END .............................................................................................. 161
CAL ERROR ............................................................................................... 161
METER BG NOW .......................................................................................... 162
METER BG BY ............................................................................................. 162
LOW XX MG/DL (XX = SG measurement) ............................................................. 162
HIGH XXX MG/DL (XXX = SG measurement) ......................................................... 162
LOW PREDICTED ......................................................................................... 162
HIGH PREDICTED ........................................................................................ 163
RISE RATE ................................................................................................ 163
FALL RATE ................................................................................................ 163
SENSOR ERROR ........................................................................................... 163
Alarms ....................................................................................................... 163
What to do ............................................................................................... 164
Alarm conditions ........................................................................................... 164
A (ALARM) ................................................................................................ 164
AUTO OFF ................................................................................................ 165
BATT OUT LIMIT ......................................................................................... 165
BOLUS STOPPED ......................................................................................... 165
BUTTON ERROR .......................................................................................... 165
CHECK SETTINGS ........................................................................................ 165
E (ERROR) ................................................................................................ 165
EMPTY RESERVOIR ....................................................................................... 166
FAILED BATT TEST ...................................................................................... 166
FINISH LOADING ......................................................................................... 166
MAX FILL REACHED ...................................................................................... 166
Contents xvii
Page 18
MAX DELIVERY ........................................................................................... 167
MOTOR ERROR ........................................................................................... 167
NO DELIVERY ............................................................................................. 167
NO RESERVOIR ........................................................................................... 167
OFF NO POWER .......................................................................................... 167
RESET ..................................................................................................... 167
WEAK BATTERY .......................................................................................... 167
Testing the transmitter ................................................................................... 168
Connecting the tester .................................................................................. 168
Disconnecting the tester ............................................................................... 169
Troubleshooting sensor features ........................................................................ 169
Reconnect old sensor ................................................................................... 169
Find lost sensor .......................................................................................... 170
Chapter 14: Maintenance ................................................................ 171
Battery ...................................................................................................... 171
Storage ...................................................................................................... 172
Cleaning your pump ....................................................................................... 172
Cleaning the transmitter ................................................................................. 172
Cleaning the Sen-serter ................................................................................... 173
Chapter 15: Pump specifications ....................................................... 175
Alarms and error messages ............................................................................... 175
Alarm history ............................................................................................... 175
Audio frequency ........................................................................................... 175
Backlight .................................................................................................... 176
Basal ......................................................................................................... 176
BG Target ................................................................................................... 176
Bolus delivery .............................................................................................. 176
Maximum bolus ............................................................................................. 176
Bolus history ................................................................................................ 176
Bolus units .................................................................................................. 177
Bolus Wizard feature ...................................................................................... 177
Carb ratios .................................................................................................. 177
Carb units ................................................................................................... 177
Daily totals .................................................................................................. 177
Default screen .............................................................................................. 177
Contents
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Page 19
Delivery accuracy .......................................................................................... 178
Pump motor ................................................................................................ 178
Dual Wave bolus ........................................................................................... 179
Easy bolus ................................................................................................... 179
Filling the infusion set .................................................................................... 179
Infusion pressure ........................................................................................... 179
Insulin sensitivity .......................................................................................... 179
Low resv (reservoir) warning ............................................................................. 180
Meter value ................................................................................................. 180
Normal bolus ............................................................................................... 180
Occlusion detection ....................................................................................... 180
Percent temp basal ........................................................................................ 180
Power supply ............................................................................................... 181
Reservoir + Set history .................................................................................... 181
Program safety checks .................................................................................... 181
Pump size ................................................................................................... 181
Pump weight ................................................................................................ 181
Remote control ............................................................................................ 181
Reservoir .................................................................................................... 181
Square Wave bolus ........................................................................................ 182
Temporary (temp) basal rate ............................................................................ 182
Time and date screen ..................................................................................... 182
Environmental conditions ................................................................................ 182
Radio frequency (RF) communication specifications ................................................. 182
Quality of service .......................................................................................... 182
Data security ............................................................................................... 182
Status screen ............................................................................................... 183
Bolus Wizard feature specifications .................................................................... 185
Bolus Wizard feature examples .......................................................................... 188
Insulin delivery default settings ......................................................................... 190
Bolus Wizard feature default settings .................................................................. 192
Sensor features default settings ......................................................................... 193
Guidance and manufacturer's declaration ............................................................. 196
Icon table ................................................................................................... 202
Appendix A: Sensor accuracy ........................................................... 203
Performance results in adults ........................................................................... 204
Contents xix
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Accuracy of Guardian RT readings ...................................................................... 205
Precision of Guardian RT readings ...................................................................... 209
Low and High alerts in adults ............................................................................ 210
The Low Glucose alert ................................................................................. 210
The High Glucose alert ................................................................................. 211
Guardian RT sensor performance and calibration stability as a function of time ............... 212
Effects of calibration frequency ......................................................................... 215
Time-elapsed plots ..................................................................................... 216
Performance results in children and adolescents ..................................................... 219
Accuracy of Guardian RT readings ................................................................... 219
Low and High alerts in children and adolescents ..................................................... 223
The Low Glucose alert ................................................................................. 223
The High Glucose alert ................................................................................. 224
Glossary ...................................................................................... 225
Index ......................................................................................... 233
Contents
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Introduction
Thank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner in helping you gain better control of your diabetes. Whether you are beginning pump therapy for the first time or upgrading from a previous model, we believe that the combination of state-of-the-art technology and the simple, menu-driven programming of the pump will provide many benefits.
This user guide is designed to help you to understand pump therapy and the operation of your Medtronic MiniMed Paradigm
®
REAL-Time Revel™ insulin pump. We strongly recommend that you work closely with your
healthcare professional for a safe and complete pump start.
Assistance
Medtronic Diabetes provides a 24 Hour HelpLine for assistance. The HelpLine is staffed with representatives who are trained in the set-up and operation of the pump and are able to answer pump-related questions. When calling the HelpLine or your local Medtronic Diabetes office, please have your pump and serial number available. The phone number for the 24 Hour HelpLine is also on the back of your pump.
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. Inform a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to the User safety section in this chapter for more information on pump safety. Your emergency kit should include these items:
Fast-acting glucose tablets
Blood glucose monitoring supplies
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Urine ketone monitoring supplies
Extra Paradigm
®
compatible infusion set and Paradigm reservoir
Insulin syringe and fast-acting insulin (with dosage instructions from your healthcare professional)
Wallet card
Dressing and adhesive
Glucagon Emergency Kit
®
Extra AAA alkaline batteries (Energizer® brand is recommended)
CAUTION: If you give yourself insulin by using a syringe, the Bolus Wizard feature will not be able to correctly determine the active insulin in your system. Consult with your healthcare professional on how long you need to wait after a manual injection before you can rely on the active insulin calculation of your Bolus Wizard feature.
Consumables
The pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions for Paradigm reservoir and Paradigm compatible infusion sets are provided in the Starting on insulin chapter.
Reservoirs — The 523 and 523K pumps are only used with the 176-unit Paradigm reservoir (MMT-326A).
The 723 and 723K pumps can be used with either the 300-unit Paradigm reservoir (MMT-332A) or the 176­unit reservoir, depending on your insulin needs.
Infusion sets — Medtronic Diabetes provides a variety of Paradigm-compatible infusion sets to fit your
needs. Contact your healthcare professional for help in choosing an infusion set that fits your needs. Change your infusion set every two to three days.
WARNING: For your protection the pump has undergone extensive testing to confirm appropriate operation when used with Paradigm reservoirs and Paradigm compatible infusion sets manufactured or distributed by Medtronic Diabetes. We recommend using Medtronic Diabetes infusion sets and reservoirs as we cannot guarantee appropriate operation if the pump is used with reservoirs or infusion sets offered by third-parties and therefore we are not responsible for any injury or malfunctioning of the pump that may occur in association with such use.
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Accessories
Meter — Your pump can be used with an optional blood glucose meter powered by MWT1 technology
(where or if available). MWT1 is the wireless Radio Frequency (RF) technology that is used to transmit information from the meter to the pump. You can program your pump to automatically receive your BG reading from this meter. All meters referenced in this user guide are blood glucose meters supported by MWT1 technology.
Remote control — The optional Paradigm remote control can be used with the pump to deliver normal
boluses and suspend/resume the pump from a distant location. (This user guide provides programming instructions for the remote control. Refer to the remote control user guide for operating instructions.)
Medtronic MiniLink
®
Transmitter — The transmitter (MMT-7703) is a small device that connects to the
sensor. It comes with a tester and a charger. When connected to a sensor that is inserted in the body, the transmitter automatically initializes the sensor and begins to periodically send glucose data to the pump using a radio signal.
Sensor — The sensor (MMT-7002/MMT-7003) continuously converts tiny amounts of glucose from your
fatty layer under the skin into an electronic signal. This signal is sent to the transmitter.
CareLink USB Upload Device — The Medtronic Diabetes CareLink USB (MMT-7305) is used to download
the Paradigm 523, 723, 523K or 723K pump data to the diabetes management software using a USB port on your computer.
To order supplies, call 800-646-4633, +1-818-362-5958 (outside U.S.), refer to the contacts list at the beginning of this user guide, or visit our web site at www.medtronicdiabetes.com.
How to wear your pump
There are different ways to wear your pump. Medtronic Diabetes has optional accessories that can hide, protect, and add to the convenience of wearing a pump. Refer to the accessories catalog or the website (www.medtronicdiabetes.com) for more information.
Holster — To wear the pump on your belt.
Pump clip — To wear the pump underneath your clothing.
Activity guard — If you are active in sports, or you are a child, use the guard to protect the pump from
disconnecting.
Leather case — Fine leather lined with nylon. Styling complements business and formal wear. Velcro
flap provides easy access for programming. Wear it vertically with the built-in belt clip.
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How to use this guide
NOTE: This user guide shows sample screens only. Your pump screens may be slightly different.
For step-by-step instructions, refer to the appropriate sections in this guide. Refer to the Glossary for definitions of terms and functions. The terms and symbols used in this guide are in the table below.
Conventions
Meaning
Press to push and release the button Hold to push and keep pressure on the button
Select
to press or to highlight a screen item you want to select
Exit the menus press ESC until the HOME screen appears Pump buttons always bold and uppercase; for example, ESC, ACT Screen and menu names always uppercase; for example, MAIN MENU, REWIND screen Menu selections always bold; for example, 24-Hour Setup, On, Off
Flashing (blinking) screen item
you can change the value for that item with the or buttons
NOTE and TIP additional helpful information
CAUTION
warns of a potential hazard which, if not avoided, may result in minor or moderate injury to the equipment
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
Go to the...screen.
when a step instructs you to go to a certain screen, the path to that screen is shown. For example: Go to the ALARM MENU.
Main > Utilities > Alarm
1
From the MAIN MENU, select Utilities and press ACT.
2
In the UTILITIES MENU, select Alarm and press ACT.
3
The ALARM MENU appears.
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User safety
Indications
Paradigm REAL-Time Revel insulin pump
The Paradigm REAL-Time Revel insulin pumps (523/723/523K/723K) are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Paradigm REAL-Time system consists of the Paradigm MMT-523/723 insulin pumps, or the MMT-523K/723K pediatric versions of the insulin pumps, the MMT-7002/ MMT-7003 glucose sensor, and the MMT-7703 transmitter. Use of the MMT-523/723 insulin pumps with the optional sensor and transmitter components is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older). Use of the MMT-523K/723K insulin pumps with the optional sensor and transmitter components is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in children and adolescents (ages 7 through 17). The pediatric system provides an alert if glucose levels fall below or rise above preset values. Glucose values provided by the Paradigm 523/723/523K/723K systems are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the sensor glucose readings provided by the Paradigm 523/723/523K/723K systems.
Meter
The Paradigm pump can be programmed to receive fingerstick blood glucose values transmitted from Bayer's CONTOUR
®
NEXT LINK Wireless Meter, Bayer's CONTOUR® LINK Wireless Meter, a OneTouch® UltraLink
®
meter, or a BD Paradigm Link® glucose meter for use in the Bolus Wizard calculator and for use as calibration values for the glucose sensor. Glucose values from other glucose meters must be manually entered into the pump.
Contraindications
Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day and to maintain contact with their healthcare professional. Successful insulin pump therapy requires sufficient vision or hearing to allow recognition of the pump signals and alarms.
Do not expose your insulin pump to MRI equipment or other devices that generate very strong magnetic fields. The magnetic fields in the immediate vicinity of these devices can damage the part of the pump’s motor that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia.
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Your pump must be removed and kept outside the room during magnetic resonance imaging (MRI) procedures.
If your pump is inadvertently exposed to a strong magnetic field, discontinue use and contact the 24 Hour HelpLine for further assistance.
Warnings
Pump
The pump is not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide.
Reservoir and infusion sets
Standard Luer sets are not compatible with the Medtronic MiniMed Paradigm pump. Medtronic Diabetes Paradigm reservoirs and Paradigm-compatible infusion sets are specifically designed for use with the pump. Do not modify your Paradigm reservoir or Paradigm-compatible infusion set.
Do not put any other drugs/medications inside your reservoir to use with this pump. Only insulin that has been prescribed by your physician can be used in this pump.
Sensor
Bleeding, swelling, irritation and/or infection at the insertion site are possible risks associated with inserting the sensor and sometimes result from improper insertion and maintenance of insertion site.
Transmitter
Product contains small parts and may pose a choking hazard for young children.
Optional occlusive dressing should be removed if irritation or reaction to this develops.
Magnetic fields
Do not use pump cases that have a magnetic clasp.
Do not expose your insulin pump to MRI equipment or other dev ices that ge ner ate very str ong mag netic fi eld s. The magnetic fields in the immediate vicinity of these devices can damage the part of the pump’s motor that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia.
Your pump must be removed and kept outside the room during magnetic resonance imaging (MRI) procedures.
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If your pump is inadvertently exposed to a strong magnetic field, discontinue use and contact our 24 Hour HelpLine for further assistance.
X-rays, MRIs and CT scans
If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, take off your pump, sensor, transmitter, meter and remote control before entering a room containing any of these
equipment.
The Paradigm pump is designed to withstand common electromagnetic interference, including airport security systems. Be sure to carry the Emergency Card provided, when you are traveling. This card provides airport information.
Precautions
Although the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has lost its potency. It is essential, therefore, that you test your blood glucose levels at least four times per day. If your blood glucose is out of range, check the pump and the infusion set to ensure that the necessary amount of insulin is being delivered.
Avoid extreme temperatures
1 Avoid exposure of your pump and remote control to temperatures above 108°F (42°C) or below 34°F
(1°C).
2
Insulin solutions freeze near 32°F (0°C) and degrade at high temperatures. If you are outside in cold weather, wear your pump close to your body and cover it with warm clothing. If you are in a warm environment, take measures to keep your pump and insulin cool.
3
Do not steam, sterilize or autoclave your pump or remote control.
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Infusion sets and sites
Avoid using an infusion set insertion site that will be irritated by clothing and accessories, or by rigorous stretching and exercise.
Sensor
Prior to exercising, make sure the sensor is firmly attached.
Adverse reactions
Operation of the sensor feature requires the insertion of a glucose sensor into the skin. Bleeding, swelling, bruising, or infection at the sensor insertion site are possible risks of sensor use. The sensor should be removed if redness, pain, tenderness or swelling develop at the insertion site. The optional occlusive dressing should be removed if irritation or a reaction to this develops. Contact your doctor and our 24 Hour HelpLine in the event of any adverse reaction.
Notice
CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic Diabetes could void your ability to operate the equipment.
Insulin pump and RF accessories
The pump, meter, transmitter and remote control comply with the United States Federal Communications Commission and international standards for electromagnetic compatibility.
Do not use the RF meter to send your blood glucose reading to the pump while on an aircraft. Manually enter your blood glucose.
These devices comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesirable operation. It does not interfere with any RF signals transmitted from outside sources.
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These standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference. Operation is subject to the following two conditions:
1
This device has been tested and found to comply with the regulations governing such devices in your area. For the specific regulation and test results for your area, please contact our 24 Hour HelpLine.
2
This device generates, uses, and can radiate radio frequency energy and, if installed and used in accordance with the instruction, may cause harmful interference to radio communications. If the device does cause interference to radio or television reception, you are encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the insulin pump/remote control/transmitter/meter
Increase the separation between the insulin pump/remote control/transmitter/meter and the
device that is receiving/emitting interference
The meter and the transmitter send information to the pump using radio frequency. If other devices that use radio frequency are in use, such as cell phones, cordless phones and wireless networks, they may prevent communication between the pump and the meter. This interference will not cause any incorrect data to be sent and will not cause any harm to your pump or meter. Moving away from or turning off these other devices may allow communication. Refer to the Troubleshooting, alerts and alarms chapter to correct interference problems you may have.
Wireless transmission between the pump and transmitter within the 6 feet (1.8 meters) operating range may be interrupted due to the transmitter orientation and the pump position on the body. Move the pump closer to the transmitter or to another position. If a Lost Sensor alarm has occurred retry:
Main > Sensor > Link to Sensor > Find Lost Sensor
If you have questions, please contact the 24 Hour HelpLine.
RF interference from other devices
Common consumer electronic devices that transmit in the same frequency band used by the MMT-7703 MiniLink transmitter may prevent the pump from receiving the glucose information sent by the transmitter. Most cellular (mobile) phones and 900 MHz cordless phones, when transmitting or receiving, may cause significant interruption of transmitter-receiver communication. It is likely that other devices operating in similar frequency ranges will have a similar effect. This interference, however, will not cause any incorrect data to be sent and will not cause any harm to your transmitter.
The pump includes a programmable WEAK SIGNAL alert that notifies you when one or more expected transmissions were not received as expected by the pump. (The pump will also issue a LOST SENSOR alert if communication is interrupted for an extended period of time.)
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Communication problems can usually be resolved by:
ensuring that there is less than 6 feet (1.8 meters) between the receiving device and transmitter, to
include RF glucose meters;
turning off or moving away from other RF transmitting devices; or
reorienting or relocating the transmitter or receiving device, or both.
Communications problems may also occur due to cellular telephone interference. Testing conducted with several different cellular telephones indicates that, while a glucose value is being transmitted, using a cell phone within 12 inches (31 cm) of receiving devices, transmitters or RF glucose meters can interfere with reception of the transmitted values. In the event of such interference, normal communication can be re­established by:
turning the cell phone off; or
keeping the cell phone at least 12 inches (31 cm) away from the receiving device, transmitter or glucose
meter when a glucose measurement is being transmitted.
If you have questions, please contact the 24 Hour HelpLine.
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The basics
Your pump
CAUTION: Never use sharp objects to press the buttons on your Paradigm pump as this can damage the buttons or compromise the seal of the pump. Some examples of sharp objects that may damage your keypad are fingernail files, pens or pencils, paper clips, knives, scissors, and keys.
Take a look at your pump. The reservoir window allows you to view the insulin in the reservoir. The reservoir, with the tubing connector attached, is inserted into the reservoir compartment of the pump.
E S C
reservoir
window
screen
tubing
connector
reservoir
compartment
battery
compartment
buttons
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Install battery
CAUTION: Do not use a rechargeable or carbon zinc battery in your pump. For best results use a new Energizer AAA alkaline battery, size E92, type LR03.
Medtronic Diabetes designed the pump to only accept a new battery. As a safety measure, if you install a battery that does not have full power, the WEAK BATTERY or FAILED BATT TEST alarm may sound. If you receive a WEAK BATTERY alarm, respond to the alarm and continue. The pump will still operate normally, but with a decreased battery life. The pump uses one AAA alkaline battery.
1
Make sure all the following apply:
Clear (ESC, ACT) any alarms and/or alerts before removing and replacing the battery.
Make sure the pump is at the HOME (idle) screen when you remove the battery.
Do NOT remove the battery during a bolus or Fill Cannula delivery.
2
Use the edge of a coin to remove the battery cap. Turn the cap in a counter-clockwise direction.
3
Remove the old battery and dispose of it per the disposable requirements of your state or country. Put the new battery in the pump with the negative end [(-) symbol] going in first. Check the label on the back of the pump to make sure the battery is inserted correctly.
NOTE: Do not use batteries that have been in cold
storage, such as in the refrigerator or in your car during winter in cold climates.
battery cap
battery
4 Place the battery cap in the pump and tighten so the slot is aligned
horizontally with the pump as shown here:
CAUTION: Do NOT over-tighten the battery cap. You should not turn the cap more than four half turns. If you over-tighten the cap you may not be able to remove it, and you can damage your pump.
one half-turn
one half-turn
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5 While the pump turns on, it will show one or more screens until the
HOME screen appears. If the HOME screen does not appear, do these steps:
a. Check that the battery is inserted correctly. If the battery has
been installed backwards, remove the battery and install it properly.
b. If your pump still does not turn on or you get a FAILED BATT
TEST alarm, remove and replace the battery with a new one.
c. If the pump is still not on, call our 24 Hour HelpLine.
HOME screen
6 Check to make sure the time and date are correct. If more than five minutes have passed since you
removed the battery, you will be prompted to check the time and date. Refer to the Setting the time and date section in the Basic programming chapter for programming instructions.
7
Press ESC to view the STATUS screen, making sure no alarms are active. If an alarm is active, follow the instructions on the screen.
Pump buttons
The buttons on the pump are used to navigate through the menus and screens, and to program the features of the pump.
UP button
From the HOME screen, this is the EASY BOLUS button
DOWN
button ACT button
ESC
button
EXPRESS
BOLUS
button
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The following table describes how to use the buttons on your pump from the HOME screen:
Button
Description
EASY BOLUS™ button – Shortcut to set and deliver an Easy Bolus.
Turns the backlight on or off.
Opens the MAIN MENU.
Opens the pump STATUS screen if the sensor feature is turned off.
Opens the following screens and graphs from the HOME screen if the sensor feature is
turned on:
1 press opens the last sensor graph selected.
2 presses open the pump STATUS screen.
3 presses open the SENSOR STATUS screen.
EXPRESS BOLUS button – Shortcut to set any bolus.
The following table describes how to use the buttons on your pump from the menus and programming
screens:
Button
Description
Increases or decreases the value of a flashing item. Scrolls up or down the items in a list.
Accepts a selected menu item or activates a selected setting.
Returns to previous screen or exits the menu.
Backs out of unintentional menu selections if the ACT button has not been pressed yet.
Press simultaneously with to turn on backlight when in the menus.
Use as a Shift button by pressing it in combination with another button to access certain
features.
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The pump screen
The screen shows five lines of text at one time. The first is the operating mode. The second is the current open menu or function. The last three lines show either information or text that you can select for the current function.
NOTE: The screen text in the examples used in this guide might not exactly match the text on your pump
screen. Please follow your pump screen instructions. If you have any questions, contact our 24 Hour HelpLine.
HOME screen
The HOME screen serves as the starting point to access the programming screens. When no buttons are pressed for about 30 seconds, the pump returns to this screen.
When you press ACT from the HOME scree n, the MAIN MENU w ill appe ar.
When the pump is on, the following icons always appear across the top of the screen: reservoir volume icon, the time (12- or 24-hr), and the battery icon. If these do not appear, the pump is not operating.
Screen icons
There are various icons that appear at the top of your pump screen, like the time, battery and reservoir icons mentioned above. The next sections describe what the icons mean.
Battery
The battery icon tells you how much usable life is left in your battery. There are four segments in the icon. Each segment represents approximately 25 percent of the usable battery life you have left until you reach Low Battery point. So if you only have one segment left, make sure you have a new battery available.
At least 75% left
Low battery
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Time display
The current time of day is displayed across the top of the pump screen in the format you select—12-hour or 24-hour. The AM or PM is only displayed for the 12­hour format. For instructions on setting the time on your pump, see the Setting the time and date section in the Basic programming chapter.
Reservoir volume
The reservoir volume icon tells you how much insulin is in your pump. This icon is also divided into four segments. Each segment represents approximately 25 percent of the reservoir volume you have left. This allows you to be aware of how much insulin you have left in your pump. Refer to your STATUS screen to view the number of units left in the reservoir.
NOTE: For the Paradigm 723/723K pump, your reservoir icon will only appear full
if using a filled 300–unit Paradigm reservoir. The icon will not appear full if you use the 176–unit Paradigm reservoir.
Alert and alarm icons
An open circle (alert) or a solid circle (alarm) are displayed in the upper part of your pump screen only when there is an alert or alarm condition on your pump. For alarm and alert information, see the Troubleshooting, alerts and alarms chapter.
Sensor icons
A dark sensor icon means that the sensor is on and the pump is receiving sensor data. A light-colored sensor icon with a dark circle around it means that the sensor is on, but the pump is not receiving sensor data. For information about the sensor, see the Sensor features chapter.
Time Display
24-Hr
12-Hr
Less than 25% left
75 to 100% left
Alarm icon
Alert icon
Sensor is on and the pump is receiving sensor data
Sensor is on but the pump is not receiving sensor data
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Scroll bar
If there is more text than the screen can show, a scroll bar appears on the right side of the screen. Press
to view any additional text.
Screen backlight
When you press from the HOME screen, the light on the screen turns on or off. During programming, the backlight can be turned on by
pressing the
and the together. The light will stay on while you are pressing any of the pump buttons.
It will stay on as long as the current screen is active.
To conserve your battery, the backlight will turn off automatically while the pump is vibrating. After the vibration is finished, the light will turn back on. The backlight cannot be turned on in a low or dead battery condition.
Beep/vibrate
Your pump will beep or vibrate to indicate activity. Refer to the Setting your alert type section in the Utilities chapter for setup instructions.
Operating modes
The screen lets you know when a special feature is active or if there is a condition that needs your attention. The active features and pump status will determine the operating mode. The screens for the three modes are shown in the following sections.
scroll bar
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Normal mode
Mode for standard pump operations for normal basal and bolus delivery. No special features are active (such as basal patterns, temp basal, and others). No alarms and no alerts exist.
Special mode
Indicates a special feature is active or an alert condition(s) exists. Special mode does not restrict any of the pump functions. When the pump is in Special mode, an open circle appears at the top of the screen and it beeps or vibrates periodically to remind you of the condition. The conditions and features that put the pump in Special mode are:
Low Reservoir condition
Low Battery condition
Block feature is on
Dual or Square Wave bolus delivery
Basal pattern A or B is active
Sensor alerts
Temporary basal delivery
Alert Silence is active
Attention mode
WARNING: When the pump is in Attention mode, showing a solid circle icon, all insulin deliveries are stopped.
Indicates insulin delivery has stopped. This can mean that the pump is in Suspend mode. It can also mean an alarm is active or an alarm condition exists that needs immediate attention for insulin delivery to resume. A solid circle appears at the top of the screen and the pump will beep periodically until either the pump is taken out of Suspend mode or the condition is cleared. The screen will show text describing the condition that put the pump in Attention mode. For example, if the reservoir is empty, EMPTY RESERVOIR will appear on the screen.
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When the pump is in Attention mode, it will beep or vibrate periodically to remind you of the condition. The beep or vibrate frequency varies depending on the condition that put the pump in Attention mode. Refer to the Alarm conditions section in the Troubleshooting, alerts and alarms chapter for alarm conditions that will trigger the Attention mode. See the Stopping your pump section in the Basic programming chapter to learn about Suspend mode.
Menus
The MAIN MENU is the highest level menu. There are submenus, functions, status and programming screens in the lower menu levels. The menus are described in the following paragraphs.
Tip: If a screen item is flashing (blinking), during programming, press or to change the value.
MAIN MENU
Highest menu level in the menu system. When you press ACT from the HOME screen, the MAIN MENU will appear.
BOLUS MENU
Contains the settings and functions for bolus deliveries. The button allows direct access to MANUAL BOLUS or to the BOLUS WIZARD feature without having to navigate through the menus. Refer to the Basic
programming chapter for the manual bolus information or to the Using the Bolus Wizard feature chapter for bolusing using the Bolus Wizard feature.
SUSPEND
Stops all current insulin deliveries. Refer to the Stopping your pump section in the Basic programming chapter for more information.
SENSOR
Contains the functions to setup the interface between the sensor and the pump and access to the pump's sensor features.
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CAPTURE EVENT
Contains the options you use to enter information about different events into the system. Examples of events include: the amount of insulin used for injections, and the carbohydrates consumed during meals or snacks. The Capture Event option appears in the MAIN MENU after this feature has been turned on in the UTILITIES MENU menu. See the Capturing Events section in the Basic programming chapter for more details.
BASAL MENU
Contains the functions to setup and deliver your basal. Refer to the Basal section in the Basic programming chapter for more information.
RESERVOIR + SET
Contains the functions required to change your reservoir and fill the infusion set with insulin. Refer to Changing your infusion set section in the Starting on insulin chapter for more information.
UTILITIES MENU
Contains features for your safety and convenience. Refer to the Utilities chapter for more information.
STATUS screen
The STATUS screen shows information about what your pump is doing. Only check your pump status (press ESC) when you are not programming your pump. If you press ESC during programming, you will cancel the settings you are trying to enter.
The information that shows on the STATUS screen depends on the current activities and conditions of your pump.
To open the STATUS screen, press ESC until the STATUS screen appears.
To view more text on STATUS screen, press
or to scroll and view all of the information.
To exit the STATUS screen, press ESC until the STATUS screen disappears.
The screen includes information about:
Last bolus insulin delivery
Current basal insulin delivery
The amount of active insulin, if any
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Special features that are turned on
Last alarm/alert that was cleared within 24 hours
Most recent BG meter reading received within 24 hours
Reservoir status
Battery status
Time and date
Refer to the Pump specifications chapter for a complete list of the information that is available in the STATUS screen.
If you remove your pump
You may have an occasion when you need or want to remove your pump. If you have to remove and store your pump, it is recommended that you do the following:
Store your pump with the battery in place
Keep a record of your current basal rates and use the Save Settings feature (see the Saving the settings
section in the Utilities chapter).
To preserve battery life, reset the basal rates to 0 (zero), turn off the RF options (meter, remote), and
set Auto-off to dashes or zeroes.
Remember, your body still needs insulin while your pump is removed.
It is important that you consult with your healthcare professional to determine an alternate method of receiving your insulin. You can remove your pump for up to one hour without taking insulin. If you remove your pump for more than one hour, you will have to use another way to take your insulin, such as injections of fast-acting insulin, or reconnecting your pump to take boluses. Take the injection or bolus approximately every four hours. Calculate the amount of insulin to take based on the total of your basal insulin in four hours. Include the amount you need for meal and correction boluses. If you will have your pump off for several days, you will need to return to a multiple injection regimen.
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Basic programming
Setting the time and date
Setting the correct time and date in your pump is necessary for accurate basal insulin delivery and allows you to keep an accurate record of your insulin delivery and other pump functions. You can select a 12-hour or 24-hour clock. You must reset the time and date if you receive a CHECK SETTINGS alarm or you clear your settings (Clear Settings function).
1
Go to the TIME/DATE SETUP screen.
Main > Utilities > Time/Date
2 Select 12-Hour Setup or 24-Hour Setup and press ACT.
3 Press ACT again to change the settings.
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4 Change each of the settings as follows:
a. Hour
Change the hour. Press ACT. For 12-hour setups, press
or until the correct A (am) or
P (pm) appears.
b. Minutes
Change the minutes. Press ACT.
c. Year
Change the year. Press ACT.
d. Month
Change the month. Press ACT.
e. Day
Change the day. Press ACT.
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5 The TIME SET AT screen will show the settings that you
programmed. Press ACT and exit the menus. Your time/date settings are complete.
Selecting the language
The language shown on the pump screens can be changed. Some languages may not be available on all pumps. Before you can select another language, you need to set the time using the English screens. Refer to the previous section.
To change the language for your pump:
1
Go to the LANGUAGE MENU screen.
Main > Utilities > Language
2 Select your language, then press ACT.
3 The language setting is now changed. Exit the menus.
Bolus
There are three bolus types: Normal, Square Wave®, and Dual Wave®. This section gives instructions for a Normal bolus using the EXPRESS BOLUS button and navigating through the menus. (For information about Square Wave and Dual Wave boluses, refer to the Optimizing pump therapy chapter.)
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The Normal bolus delivers an immediate food or correction bolus. It can be delivered at any time except during another Normal bolus. During a Normal bolus, most pump features are disabled until after all the bolus has been delivered. The suspend function and the STATUS screen, however, are always available.
Setting the Normal bolus
Normal bolus can be used to cover the carbohydrate in a meal or snack and/or to correct a blood glucose that is higher than your blood glucose target.
The following instructions are for a Normal bolus when the Bolus Wizard feature is turned off. 1
Go to the BOLUS MENU.
Main > Bolus
Select Set Bolus and press ACT. Go to step 2. You can also use the
EXPRESS BOLUS button to get to step 2. Press from your HOME screen.
2
a. If the SET BOLUS screen appears: (Dual/Square option is off) Go to step 3. b. If the BOLUS TYPE screen appears: (Dual/Square Wave is on) Select Normal Bolus and press ACT.
Go to step 3.
3
The SET BOLUS screen (or SET NORMAL BOLUS screen if the Dual/Square option is on) appears with
0.0 unit bolus amount flashing. Enter your bolus amount and press ACT. If some of the bolus insulin delivered by the pump has not been used and is active in your body, the
screen will show this amount as Act. Ins. (Active Insulin). This amount is based on the active insulin setting selected in the Bolus Wizard feature. The Active Insulin amount shows even if the Bolus Wizard feature is turned off. Take this amount into consideration to determine your bolus. See About active insulin, on page 72 for more information.
NOTE: If you have BG Reminder turned On, the BG REMINDER DURATION screen displays. It allows you
to set the duration before you are reminded to check your blood glucose after a bolus. See the BG Reminder section in this chapter for information about this feature.
4 The BOLUS DELIVERY screen appears and the Normal bolus starts. The pump will beep/vibrate at the
start of the bolus. As the bolus delivers, the amount shown on the screen will increase until the entire bolus has been delivered. When the bolus is finished, the pump will beep/vibrate again and the HOME screen will appear.
The following practice lessons will help you understand this pump feature.
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Normal meal bolus using the exchange system
Normal bolus can be used to cover the carbohydrate in a meal or snack and to correct a blood glucose that is higher than the target that was chosen for you.
Fred has been taught that he needs to take 1 unit of insulin for every carbohydrate exchange that he eats (every milk, every starch or every fruit). For lunch today he will eat:
Turkey sandwich with two slices of bread 2 starches
1 small apple 1 fruit
1 cup of non-fat milk 1 milk
__________________
Total carbohydrate exchanges = 4
Fred's lunch has a total of 4 carbohydrate exchanges so he will take a meal bolus of 4 units for his lunch.
Bolus practice:
NOTE: Make sure that you are not connected to your pump while practicing.
Going through the menus, program a 2.0 unit Normal bolus now.
Check here if you were able to program it.
Using the EXPRESS BOLUS button , program a 2.0 unit Normal bolus now.
Check here if you were able to program it.
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Normal meal bolus practice using exchanges
Choose a meal you might eat and fill in the blanks.
Food:__________ exchange:____________
__________ exchange:____________ __________ exchange:____________
total exchanges:____________
You will take _______ units of insulin for each exchange. Your total bolus is _______ for this meal.
Normal meal bolus using carbohydrate counting
Lydia has been taught that she needs to take 1 unit of insulin for every 10 grams of carbohydrate. This is her insulin to carbohydrate ratio. For dinner she will have:
4 oz. broiled chicken 0 grams
2/3 cup of rice 30 grams
1/2 cup cooked broccoli 5 grams
1 oz. dinner roll 15 grams
1 tsp margarine 0 grams
__________________
total grams of carbohydrates = 50 grams
Lydia's dinner totals 50 grams of carbohydrate. Her insulin to carbohydrate ratio is 1 unit to 10 grams. She will take a meal bolus of 5 units for her dinner. She determined this by dividing 50 (total grams of carbohydrate) by 10 (insulin to carbohydrate ratio).
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Normal meal bolus practice using carbohydrates
Choose a meal you might eat and fill in the blanks.
Food:__________ grams of carbohydrate:____________
__________ grams of carbohydrate:____________ __________ grams of carbohydrate:____________
total grams of carbohydrate:____________
Your insulin to carbohydrate ratio: 1 unit of insulin for _______ grams carbohydrate.
Divide your total carbohydrates by your insulin to carbohydrate ratio and take _____ units of insulin for your meal.
Meal bolus, correction bolus and insulin sensitivity
Jason is ready to eat his breakfast. He has calculated that he will need 4.0 units for his food.
He tests his blood glucose and finds that it is 200 mg/dL (11.1 mmol/L). Jason knows that his blood glucose level is above his blood glucose target and will need additional insulin before he eats.
Jason's healthcare professional has determined the following for him:
BG Target: 110 mg/dL (6.1 mmol/L)
Insulin sensitivity
1
: 36 mg/dL/u (2.0 mmol/L/u)
Jason determines that he will need a correction bolus of 2.5 units insulin to lower his elevated blood glucose. The 2.5 correction bolus will lower his current blood glucose of 200 mg/dL (11.1 mmol/L) to his target of 110 mg/dL (6.1 mmol/L).
elevated blood glucose: 200 110 = 90 mg/dL (11.1 6.1 = 5 mmol/L)
correction bolus: 90 / 36 mg/dL/u (insulin sensitivity) (5.0 / 2.0 mmol/L/u) = 2.5 units
(He will add this 2.5 correction bolus to the 4.0 units of insulin that he will need for his meal bolus. Jason will take a total bolus of 6.5 units.)
1. Insulin sensitivity is the amount (in mg/dL or mmol/L) by which blood glucose will be lowered after taking 1 unit of insulin.
Consult with your healthcare professional to determine your insulin sensitivity.
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Practice: Meal bolus
You have determined your meal bolus as: _______ units.
Your target blood glucose range is: _______ to _______ (average is _______).
Your current blood glucose level is: _________.
Your correction factor is: 1 unit of insulin will drop your blood glucose _________.
You will take ________ unit(s) of insulin to correct your high blood glucose level.
Your total bolus (meal bolus plus correction bolus) is _________.
Review your bolus deliveries
You can view a list of your bolus deliveries in the BOLUS HISTORY screen. This screen shows a list of the dates, times, units, and types for your last 24 boluses. This feature is helpful for record keeping or to check if you bolused for your last meal.
If a bolus was stopped before delivery was complete, the BOLUS HISTORY screen will show only the amount actually delivered. Refer to the Bolus details section in this chapter for instructions about viewing bolus details.
Do the following steps to view the BOLUS HISTORY screen: 1
Go to the BOLUS HISTORY screen and scroll through the bolus deliveries.
Main > Bolus > Bolus History
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If you used the Bolus Wizard feature to deliver any of these boluses, the BOLUS HISTORY screen shows the carbohydrate/food (CH) and blood glucose values that the Bolus Wizard feature used to calculate the boluses.
(with the Bolus Wizard feature)
date
time
amount/type
carb value BG value
N = Normal S = Square Wave DN = Normal part of dual wave bolus DS = Square part of dual wave bolus
2 Refer to the instructions in the Bolus details section to see the details for any of these boluses.
Bolus details
You can view the details of any of the deliveries in the BOLUS DETAIL screen. The details include:
bolus types: normal, square, and dual
programmed bolus amount
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delivered bolus amount
Bolus Wizard feature information (if used)
To see the details of any bolus, do these steps:
1
In the BOLUS HISTORY screen, select the bolus that you want to review and press ACT.
2
The details for that bolus will appear on the screen. Scroll through the details.
Press the down key to see the details
If the Bolus Wizard feature calculated your bolus, more information will appear in the BOLUS DETAIL screen.
delivery is active
delivery stopped
delivery completed
Without the Bolus Wizard feature With the Bolus Wizard feature
3 Exit when you are done.
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Maximum bolus limit
The Maximum bolus (Max bolus) is a safety feature that limits the amount of insulin that can be delivered in a single bolus. The factory setting is 10.0 units. You can specify the limit from 0.0 to 25.0 units. It is important to discuss this feature with your healthcare professional to determine your Max bolus amount.
To set the Maximum bolus limit, do these steps: 1
Go to the MAX BOLUS SETUP screen.
Main > Bolus > Bolus Setup > Max Bolus
2
Set your Max bolus limit and press ACT. To accept the set Max bolus limit, press ACT. To change this limit, press ESC, and then set a lower Max bolus limit.
3
Your Max bolus is set. Exit the menus.
Example 1: Max bolus
Shelby takes very small doses of insulin for her meal boluses. As a safety limit, she and her healthcare professional reset her pump with a Maximum bolus of 5.0 units.
Example 2: Max bolus
David is a growing teenager. He loves to eat big meals and requires very large doses of insulin for his food. He reset his pump with a Maximum bolus of 20.0 units so he can take more insulin when he needs to.
Scroll rate
The scroll rate feature allows you to program bolus insulin delivery in preset increments. These increments are effective on all bolus screens, except for the SET EASY BOLUS screen. See the Easy bolus setup section in the Optimizing pump therapy chapter for more information on how to set up the steps for your Easy Bolus. The factory setting for the scroll rate feature is 0.10 units, and the available options are 0.025, 0.05, or
0.10 unit increments.
When you set the scroll rate to 0.025, you can use the following increments to program a bolus:
0.025 unit increments for a bolus of 0.975 units or less
0.05 unit increments for a bolus between 1 unit and 9.95 units
0.10 unit increments for a bolus of 10 units or more
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When you set the scroll rate to 0.05, you can use the following increments to program a bolus:
0.05 unit increments for a bolus of 9.95 units or less
0.10 unit increments for a bolus of 10 units or more
When you set the scroll rate to 0.10, the increments will increase or decrease by 0.10 units during bolus programming regardless of the bolus value.
To program your scroll rate: 1
Go to the SET SCROLL RATE screen.
Main > Bolus > Bolus Setup > Scroll Rate
2
The scroll rate value appears flashing. Change the value and press ACT.
3
The pump returns to the BOLUS SETUP screen. Your scroll rate is now programmed and ready to use. Exit the menus.
Example: Scroll rate
You have set your scroll rate to 0.025 units. You need to set your pump to deliver a 2.5 unit bolus. The bolus values on the SET BOLUS screen will change in 0.025 unit increments until you reach 1.0 unit. After this the value will change in 0.05 unit increments until you reach 2.5 units in the SET BOLUS screen.
BG Reminder
After you deliver a bolus you may want to check your blood glucose. The BG Reminder is an optional feature that makes the pump beep or vibrate to remind you to check your blood glucose after a bolus. However, this reminder is not available after an Easy Bolus. Your pump is set at the factory with the BG Reminder feature turned off.
When setting a bolus, if the BG Reminder is on, your pump will ask you to set up the BG Reminder Duration. This sets how long after bolus delivery you will be reminded to check your BG. This time can be from 30 minutes to 5 hours, or NONE. The BG Reminder is not available after an Easy Bolus.
1
Go to the BG REMINDER SETUP screen.
Main > Bolus > Bolus Setup > BG Reminder
2
Select On and press ACT. The BG Reminder is now enabled. Exit the menus. Now, the next time you program a bolus, your pump will ask you for the amount of time after your bolus
before you want to be reminded to check your blood glucose.
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When the BG Reminder goes off, your pump will beep or vibrate and CHECK BG will appear on the screen. Your pump will beep or vibrate periodically until it is cleared (ESC, ACT).
When you set a BG Reminder after a bolus, the STATUS screen will show the amount of time remaining before the reminder goes off. Here, the STATUS screen indicates that the BG Reminder will go off in 18 minutes.
Capturing Events
The Capture Event feature electronically saves certain types of information. Some examples include:
Blood glucose (BG) measurements
The amount of insulin you use
The amount of carbohydrates you eat or drink
The exercise you do
Other (this can be used for anything else as needed)
Make sure that you enter events when they happen since the system records the time of the entry. You cannot change entries after you have put the information into your device. The entered information can be sent to
Medtronic CareLink
®
Personal software. Here it can be used to generate treatment reports that you can share with your healthcare professional. You can view up to 10 of the latest saved events in the CAPTURE HISTORY screen.
Turning on the Capture Event feature
The Capture Events option appears in the MAIN MENU after this feature has been turned on in the UTILITIES MENU.
To turn on the Capture Event feature, do these steps: 1
Go to the CAPTURE EVENT ON/OFF screen:
Main > Utilities > Capture Option
2
Select On, then press ACT. You will now have a Capture Event option in the MAIN MENU.
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Entering BG measurements
You can save non-calibrating BG readings in device history. Non-calibration meter BG measurements are those that are taken at times when you will not use them for calibration, such as after eating or when your blood glucose is rising or falling rapidly. You also have the option of using the entered reading for calibration purposes. Do not calibrate if your sensor is not communicating with your device.
Before you can enter BG readings, you must select the BG units for the Capture Event features. You can set the BG units to mg/dL or mmol/L.
To set the BG units: 1
Go to the BLOOD GLUCOSE UNITS screen.
Main > Capture Event > BG Units
2
Select either mg/dL or mmol/L, then press ACT. The CAPTURE EVENT menu shows.
3
You can now enter your BG reading.
To enter the BG measurement: 1
Make a note of the BG measurement.
2
Go to the ENTER BG screen.
Main > Capture Event > Enter BG
The ENTER BG screen flashes with dashes or the most recent meter BG measurement you entered.
3
Enter your new measurement, then press ACT. The BG measurement must be between 20–600 mg/dL (1.1–33.3 mmol/L). A message asks if you want to save the new measurement that is shown on the screen.
If the information is correct, select Save BG, then press ACT. Your BG is saved.
If the Bolus Wizard feature is off, the CAPTURE EVENT screen appears.
If the Bolus Wizard is on and the saved BG is below your BG Target range, the BG Saved screen
appears. This screen indicates that your saved BG is below your BG Target set in the Bolus Wizard feature, and the pump beeps three times. See Setting the BG Targets, on page 71 for more information.
If the Bolus Wizard is on, the saved BG is above your BG Target range, and the calculated
correction estimate is more than the preset scroll rate increment, the BG Saved screen appears. This screen indicates that your saved BG is above your BG Target set in the Bolus Wizard feature, and the pump beeps three times. Go to the ENTER BG screen of the Bolus Wizard feature to enter a correction bolus. See Setting the BG Targets, on page 71 for more information.
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If you want to use the new BG measurement for calibration, select Save and Calibrate. This option
is available when your sensor is communicating with the pump, and the BG measurement is between 40 mg/dL (2 mmol/L) and 400 mg/dL (22.2 mmol/L).
If the Bolus Wizard is on and the saved BG is below your BG Target range, the BG Saved screen
appears. This screen indicates that your saved BG is below your BG Target set in the Bolus Wizard feature, and the pump beeps three times. See Setting the BG Targets, on page 71 for more information.
If the Bolus Wizard is on, the saved BG is above your BG Target range, and the calculated
correction estimate is more than the preset scroll rate increment, the BG Saved screen appears. This screen indicates that your saved BG is above your BG Target set in the Bolus Wizard feature, and the pump beeps three times. Go to the ENTER BG screen of the Bolus Wizard feature to enter a correction bolus. See Setting the BG Targets, on page 71 for more information.
If the information is not correct, select Cancel, then press ACT. The CAPTURE EVENT screen
reappears with Enter BG selected. Repeat the procedure and enter the correct information.
Entering insulin injection information
Follow these steps to enter the amount of insulin you use.
1
Go to the ENTER INSULIN screen.
Main > Capture Event > Insulin Marker
The ENTER INSULIN screen flashes with dashes or the insulin amount that you most recently entered.
2
Enter the amount of insulin you used, then press ACT. A message appears asking you if you want to save this information. The Yes option is selected.
3
Make sure that the amount of insulin shown on the screen is correct.
If the information is correct, press ACT. The information you entered is saved to the system and can
now be used in reports.
If the information is not correct, select No, then press ACT. The CAPTURE EVENT menu shows.
Repeat the procedure to enter the correct information.
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Entering carbohydrate information
This section shows you how to enter information about the carbohydrates you eat or drink.
Before you begin
Before you can enter carbohydrate information, you must select the carbohydrate units (Carb Units) for the Capture Event feature. You can set the carbohydrate units to grams or exchanges.
To set the carbohydrate units: 1
Go to the CARB UNITS screen.
Main > Capture Event > Carb Units
2
Select either Grams or Exchanges, then press ACT. The CAPTURE EVENT menu shows. You are now ready to enter your carbohydrate information.
To enter carbohydrate information: 1
Determine the total units of carbohydrates in the meal or snack that you plan to eat.
2
Go to the ENTER FOOD screen.
Main > Capture Event > Meal Marker
3
The ENTER FOOD screen flashes with dashes or with the number of carbohydrate grams or exchanges you entered last time.
4
Enter the carbohydrate grams or exchanges, then press ACT. A message asks if you want to save the information that is displayed on the screen. The Yes option is selected.
5
Make sure the number shown on the screen is correct.
If the information is correct, press ACT. The information you entered is saved to the system and can
now be used in reports.
If the information is not correct, select No, then press ACT. The CAPTURE EVENT menu shows.
Repeat the steps above to enter the correct information.
Entering exercise information
Follow these steps to enter exercise information. Be consistent and enter the marker either before or after each time you exercise.
1
Follow the path below to save your exercise information:
Main > Capture Event > Exercise Marker
2
A message asks if you want to save this exercise.
3
Make your selection, then press ACT.
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Entering Other markers
This section shows you how to enter markers other than Enter BG, Insulin Marker, Meal Marker, or Exercise Marker. Examples of Other markers include: when you take medications, when you feel ill, when you are under stress, and so on. The Other marker appears in CareLink Personal reports, and shows at what time you have entered it in the Capture Event feature.
To enter Other markers: 1
Follow the path below to save your Other marker:
Main > Capture Event > Other
A message asks if you want to enter this marker.
2
Select Yes, then press ACT. Your pump saves your Other marker and returns to the CAPTURE EVENT screen.
Viewing Capture Event history
You can view up to 10 captured events saved into the device. The most recent event will be displayed at the top of the CAPTURE HISTORY screen.
To view the Capture Event history: 1
Go to the CAPTURE HISTORY screen:
Main > Capture Event > History
2
The CAPTURE HISTORY screen displays the saved events. Each event has the date and time when it was saved, the name, and any detail associated with that event.
Basal
Basal insulin is required to maintain your target glucose values when you are not eating. Your healthcare professional will calculate this rate for you. Your basal insulin accounts for approximately one half of the body's total daily insulin requirements. Your pump mimics your pancreas by delivering insulin continuously over 24 hours.
You can set your insulin pump to change rates during the day to match your needs. Your needs depend on your lifestyle and insulin requirements. Some people only use one rate throughout the day, while others find they need more. Your basal rates are made up of insulin deliveries that have start and stop times. Once set, these rates make up your 24-hour basal pattern and are repeated daily.
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Start and stop times
When you set your basal rate(s) in the BASAL MENU, your pump prompts you to set the start time for each basal delivery. The start time of one basal rate is the stop time of the previous rate. This gives you continuous basal insulin through a 24-hour period. For basal rate 1, the start time is midnight (00:00 or 12:00 a.m.) and cannot be changed. See the following sample graph of basal rates.
12:00 AM
Basal Rate 1
start time
3:00 AM
Basal Rate 2
start time
7:00 AM
Basal Rate 3
start time
9:00 PM
Basal Rate 4
start time
24 hours
rate 3
rate 4 rate 1
rate 2
The start and stop times of basal rates for this example are:
12:00 a.m. (00:00) to 2:59 a.m. (2:59) for basal rate 1
3:00 a.m. (3:00) to 6:59 a.m. (6:59) for basal rate 2
7:00 a.m. (7:00) to 8:59 p.m. (20:59) for basal rate 3
9:00 p.m. (21:00) to 11:59 p.m. (23:59) for basal rate 4
If you need one basal insulin that starts before midnight and stops after midnight, you need to set up two basal rates. These basal rates have the same rate but different start and stop times. For example, in this graph a basal rate is needed from 9:00 p.m to 2:59 a.m. (21:00 to 2:59) at one rate. Basal rate 1 always starts at midnight and should be set to end at 2:59 a.m. (2:59). After setting basal rates 2 and 3, rate 4 is set from 9:00 p.m. (21:00) to 11:59 p.m. (23:59) at the same rate as basal rate 1. This gives continuous basal insulin from 9:00 p.m to 2:59 a.m. (21:00 to 2:59) at one rate.
You cannot set a start time for one basal rate to overlap the next basal rate. The addition of a new basal rate will erase any basal rates that follow.
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For best results, setting or changing your basal rate(s) should be discussed with your healthcare professional.
Your basal settings
You must program your basal settings before you can deliver basal insulin. Keep a written record of your basal settings.
It is recommended that you set your basal rates with the assistance of your healthcare professional.
If you plan to take off your pump for an extended period of time, such as more than a day, set the basal rate to 0.000 U/H. This will ensure that the insulin delivery records in your pump are accurate. Refer to the If you remove your pump section in The basics chapter for more information.
Basal programming and delivery
NOTE:
You cannot make changes to your basal rate settings while a percent temp basal is active.
To set your basal rates: 1
Go to the SET BASAL RATE 1 screen.
Main > Basal > Basal Setup > Set/Edit Basal
2
The SET BASAL RATE 1 screen flashes the basal rate in U/H.
3
Enter your first basal rate amount and press ACT. The start time for your first basal rate is midnight and cannot be changed.
4
The SET START TIME 2 screen appears. The dashes under the screen name flash. The first basal rate is now set.
If you do not need a second basal rate for the day, press ESC. If you need to set up a second basal rate for the day, follow steps 5 and 6.
5
In the SET START TIME 2 screen, enter the start time for the next rate.
6
Press ACT. The SET BASAL RATE 2 screen appears. Enter the rate.
7
Press ACT. The SET START TIME 3 screen appears. The second basal rate is now set. If you do not need to set up any more basal rates for the day, press ESC and skip to step 9. If you need to set up more basal rates, follow steps 5 and 6 for each basal rate.
8
After you program your last basal rate, press ESC.
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9 The BASAL RATE screen appears. Your basal rate(s) will now deliver as programmed. Exit the menus.
NOTE: The pump delivers basal amounts in 0.025 U/H increments for basal rates of less than 1.00 U/H,
and in 0.05 U/H increments for basal rates of 1.00 U/H or more.
10 When you have finished programming your pump, you can save your settings. Refer to the User settings
section in the Utilities chapter for instructions.
Current basal delivery
The STATUS screen shows your current basal information.
current basal
Daily basal rate(s)
The BASAL REVIEW screen shows your daily basal rates programmed for delivery from midnight to midnight. Compare your daily insulin deliveries to your blood glucose records to help you and your healthcare professional identify your optimal daily basal insulin rate(s).
To review your basal rates, do these steps: 1
Go to the BASAL MENU screen.
Main > Basal
2
Select Basal Review and press ACT.
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3 If you do not use patterns, the STANDARD screen appears.
The delivery details for your standard basal will appear.
basal rate
start times
basal
delivery rates
(24-hour total) basal insulin
If you use patterns, the BASAL REVIEW screen appears. The current basal pattern will be highlighted. Select the pattern you want to view. Press ACT. The delivery details for that pattern will appear.
basal rate
start times
basal
delivery rates
(24-hour total) basal insulin
4 Exit the menus when you are done.
Setting the Max basal rate
Maximum basal (Max basal) rate is a safety limit for the amount of basal insulin that is able to be delivered per hour. Your pump is sent from the factory with the Max basal set to 2.00 units per hour. It is important to determine your Max basal rates with your healthcare professional. This safety feature will not allow you to program any basal rates, including patterns and temporary basal rates, that are greater than the Max basal rate.
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If you are setting your Max basal rate after your basal rates have been set, you cannot set a Max basal that is less than any of the programmed basal rates.
To set your Max basal rate, do these steps: 1
Go to the MAX BASAL RATE screen. The Max basal rate will be flashing.
Main > Basal > Basal Setup > Max Basal Rate
2
Change the rate and press ACT.
3
Your Max basal rate is now set. Exit the menus.
Example 1: Max basal
Helen has a very low insulin requirement. Her highest basal rate is only 0.400 units per hour. As a safety measure, Helen's healthcare professional set her pump with a Maximum basal rate of 1.00 units per hour.
Example 2: Max basal
Rusty needs large amounts of insulin to control his blood glucose levels. His new pump was delivered from the factory with a Maximum basal rate of 2.00 units per hour, but he needs 2.80 units per hour in the early morning. Rusty will reprogram his Maximum basal to 3.00 units per hour to accommodate his needs.
Stopping your pump
Suspend stops all insulin delivery, including the current basal and any bolus or Fill Cannula deliveries that are in progress. While suspended, your pump will not deliver insulin until you resume your pump. When you resume your pump, the basal delivery will continue.
The pump will beep or vibrate about every 15 minutes on the hour to remind you that it is not delivering insulin. Example: You suspend your pump at 11:20 AM. The pump will beep/vibrate at 11:30 AM, 11:45 AM, 12:00 PM, and so on until you resume your pump (basal resumes).
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When suspended, your pump is in Attention mode with a solid circle showing on the pump. When in Suspend, you can only resume your basal or view the STATUS screen. If the Sensor feature is turned on, you can also view the sensor graphs and the SENSOR STATUS screen. No other functions are available.
To suspend the pump: 1
Select Suspend from the MAIN MENU, and press ACT. Main > Suspend
2
SUSPEND will flash on your screen. Press ACT to stop your pump.
3 The screen will show that the pump is suspended and the time that it stopped. After less than one minute,
the pump will return to the HOME screen with a solid circle.
You can verify on your pump STATUS screen that your pump is suspended.
Resume pump delivery
When the pump is suspended, it defaults to the HOME screen with a solid circle.
To resume your pump and basal delivery, do these steps:
1
From any screen, press ACT until the RESUME screen appears. Press ACT again.
2 Your pump will beep once, then the HOME screen will appear without the solid circle.
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NOTE: A bolus or fill cannula that was stopped by suspend will not restart when you resume your pump.
You must reprogram and activate it to finish delivery.
Example: Suspend function
Helen is ready to eat her lunch. She has just programmed her pump to deliver a meal bolus when the phone rings. Helen wants to talk on the phone and not eat her lunch right away. She knows that if she lets the bolus continue and she does not eat her lunch soon, she may be at risk for low blood glucose. Helen suspends delivery of her pump to stop the bolus, but then resumes delivery to restart her basal insulin. When she is off the phone and ready to eat, she checks her STATUS screen to see how much insulin she received from the partially delivered bolus before she suspended her pump. She will reprogram a new bolus for the remainder of her bolus amount.
Practice: Suspend function
1 Make sure you are NOT connected to your pump while practicing.
Program your pump to deliver a Normal bolus of 3.0 units. Once the bolus begins, stop the bolus by suspending your pump.
Remember, when you stop the bolus delivery with SUSPEND, all insulin delivery will stop.
2 Now, RESUME delivery, so that your basal insulin will continue. 3 Check the STATUS screen. 4 How much insulin did the bolus deliver before you Suspended delivery? _______. 5 If you wanted to take the rest of the bolus later, how much would you take to equal 3.0 units?
_______.
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Practice: Resume basal delivery after a suspend
Make sure you are NOT connected to your pump while practicing.
1 Give a 3.0 unit bolus now. While it is delivering, suspend the bolus. 2
Check here if you were able to suspend the bolus.
3 Now restart the pump. 4
Check here if you were able to restart the pump.
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Starting on insulin
The Paradigm pump is intended for use with U100 insulin. The following insulins have been tested by Medtronic MiniMed and found to be safe for use in Paradigm REAL-Time insulin pumps (MMT-523, MMT-723, MMT-523K, and MMT-723K):
Humalog
Novolog
Before using different insulin with this pump, check the insulin label to make sure the insulin can be used with the pump.
Prepare your pump for use
Before continuing with the steps in this chapter, we recommend that you watch your pump training CD-ROM and complete your pump start training.
When you are done practicing and ready to use your pump with insulin, you must make sure the time and date are correct on your pump. You must also program your settings as instructed by your healthcare professional.
You will need these items:
Pump
Insulin (U100)
Paradigm reservoir and user guide
Paradigm compatible infusion set and user guide
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Setting up the reservoir
WARNING: Using cold insulin can cause air bubbles in the reservoir and tubing. If your insulin is stored in the refrigerator, allow it to reach room temperature before filling your reservoir. When filling the reservoir, take care to remove air bubbles.
Filling the reservoir
1 Remove the reservoir from the package. Make sure the plunger rod is fully extended. 2
Swab the vial with alcohol.
3
Making sure you do not push down on the plunger, press the transfer guard onto the vial.
plunger rod
transfer guard
reservoir
vial
31
4 Push down on the plunger to pressurize the vial. 5
While still holding the plunger rod, flip the vial over so the vial is up, slowly pull down on the plunger to fill the reservoir.
6
Gently tap the side of the reservoir to make any air bubbles rise to the top of the reservoir.
45
6
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7 Slowly push up on the plunger just enough to remove any air bubbles from the reservoir. 8
Slowly pull down on the plunger to fill the reservoir to the number of units desired.
9
With the vial down, hold the transfer guard. Turn the reservoir counter-clockwise, then pull straight up to remove the vial from the transfer guard.
10
Place the tubing connector onto the reservoir. Turn the connector clockwise, pressing gently against the reservoir until you feel it slide in. Push in and continue turning until the reservoir and the connector lock with a click.
7
8
9
10
11 Tap the side of the reservoir to remove any air bubbles. 12
To purge air bubbles that have risen to the top of the reservoir, push up on the plunger until you see insulin in the tubing.
13
Without pulling, turn the plunger counter-clockwise to remove it from the reservoir.
11 12
13
14 Use your reservoir immediately after you fill it. Do not store it filled.
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Changing your infusion set
Removing the reservoir
Each time you remove and replace a reservoir in your pump, you have to rewind your pump, and fill the infusion set with insulin. 1
Remove the entire infusion set from your body.
2
If attached, remove the activity guard.
3
Turn the tubing connector half-turn counter clockwise, then pull the reservoir and connector out from the pump.
tubing connector half-turn counter-clockwise
3
4 Safely dispose of the used reservoir and infusion set item in a sharps container. 5
You must now rewind your pump as described in the next section.
Rewinding your pump
Before you continue, make sure the infusion set is NOT connected to your body and the reservoir is NOT in the pump.
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WARNING: Make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin.
1 If you removed your reservoir and are replacing it, go to the REWIND screen.
Main > Reservoir + Set > Reservoir Setup
2
In the REWIND screen, press ACT to start the rewind process. The REWINDING screen will appear while the pump rewinds.
3
After the pump rewinds the REWIND COMPLETE screen will appear.
If you are practicing:
a. Do NOT insert the reservoir in your pump. Make sure the red shipping cap is installed in the reservoir
compartment as shipped.
b. Press ACT, then continue with the instructions in the Filling the tubing section in this chapter.
If you are not practicing, continue to the next section to insert the reservoir in your pump.
Inserting the reservoir in your pump
If your reservoir is already inserted in your pump, continue to the next section.
You must do these steps in the order described. If you are practicing, do NOT insert the reservoir in your
pump.
CAUTION: You must rewind your pump before installing a new reservoir. As part of the pump's function, it calculates the reservoir volume. To ensure correct volume calculations, your pump has been designed to require a rewind before you insert your reservoir.
1 If you are using the pump for the first time, remove the red shipping cap from the reservoir
compartment.
WARNING: Do not insert the reservoir in the pump if you did not rewind. Doing so could result in inaccurate insulin delivery.
Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin.
2 Insert the reservoir into the top of the pump case.
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3 Turn the tubing connector approximately 1/2 -turn clockwise until the connector is seated. The tubing
connector should be aligned horizontally with the pump case as shown here.
tubing connector
2
3
4 Attach the activity guard, if desired. 5
If the pump has returned to the HOME screen, press ACT to show the REWIND COMPLETE screen. Press ACT again to go to the FILL TUBING screen.
6
You must now fill the infusion set tubing as described in the next section.
Filling the tubing
You need to fill the infusion set tubing with insulin before you insert the set into the body.
WARNING: Make sure the infusion set is disconnected from your body before you fill the infusion set tubing. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin.
1 After you rewind your pump, the FILL TUBING screen will appear.
a. If the infusion set is NOT disconnected from your body, press ACT to select No on the screen. After
you disconnect the infusion set from your body, press ACT on the next screen to continue.
b. If the infusion set is disconnected from your body, select Yes on the FILL TUBING screen. Press ACT
to continue to the next FILL TUBING screen.
2
Press and hold ACT. The pump will beep six times indicating that the pump is positioning the reservoir.
3
After the reservoir is positioned, you need to fill the infusion set tube with insulin. Press and hold ACT until insulin droplets form on the tip of the infusion set needle, then release. Follow the instructions on the screen. You will hear beeps as the pump fills the tubing with insulin. Be sure no bubbles are in the tubing.
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WARNING: If the FILL TUBING screen does not display, do NOT continue. Do NOT insert the infusion set into your body. Please contact our 24 Hour HelpLine for assistance.
Take care to remove air bubbles when filling the infusion set tubing.
If you use more than 30 units of insulin to fill the infusion set tubing, the MAX FILL REACHED alarm screen will appear. If you get this alarm, do these steps:
a. Make sure that you are not connected to the pump. b. Read the message on the screen, then press ESC, ACT to clear. c. To continue filling the infusion set tubing, select Yes, Continue and press ACT. See the next step
to continue. If you have made a mistake, select No, Rewind and press ACT. The REWIND screen will appear. Refer to the pump rewinding and insulin loading instructions in this chapter to continue.
4
A message will appear: DO YOU SEE DROPS AT END OF TUBING? Do not press ESC because this will trigger a FINISH LOADING alarm in 10 minutes. Make sure to complete
this Fill Tubing step. Select Yes or No.
a. If you do NOT see drops at the tip of the needle, select No and press ACT. Make sure your infusion
set is NOT connected to your body. Follow the instructions on the FILL TUBING screens to continue filling the infusion set tubing with insulin.
b. If you see drops formed at the tip of the needle, select Yes and press ACT. The FILL CANNULA screen
will appear.
5
You can now insert the infusion set into your body as described in the next section.
Inserting the infusion set
WARNING: While the infusion set is connected to your body, do not unscrew and retighten the tubing connector on the reservoir.
After you complete all of the following, you will be ready to insert the infusion set into your body:
fill your reservoir
rewind your pump
insert the reservoir into pump
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and fill the infusion set with insulin
Shown here are the best body areas (shaded) for infusion set insertion. Avoid the 2-inch (5.0 cm) area around the navel.
It is important that you change your infusion set every two to three days. Be sure to rotate the infusion set insertion sites so that they do not become overused. The abdominal area is the most common site for set insertions because absorption is very consistent. To keep abdominal sites healthy, some people find it helpful to use a visual scheme to help them rotate their insertion sites in an organized way. Here are two commonly used methods. For maximum effectiveness, use both methods, alternating between them:
Visualize an imaginary clock drawn on your abdomen surrounding your belly button.
Rotate infusion set insertion sites by starting at 12 o’clock and then rotate the site clockwise to 3 o’clock, 6 o’clock, and so on.
Imagine a letter M or a letter W on either side of your belly button. Start at the end of
one letter and proceed through the letter, rotating to each intersection in turn.
Medtronic Diabetes offers different infusion sets for your pump. Instructions for the Quick-set® begin on the next page as an example. Always refer to the instructions that shipped with your infusion set.
After your infusion set is inserted, see the Filling the cannula section in this chapter to fill the infusion set cannula.
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Quick-set infusion set (with Quick-serter®)
There are different infusion sets that you can use with your pump. As an example, the following procedure shows how to insert the Quick-set infusion set. Always refer to the instructions that shipped with your infusion set.
2
4
5
7
8
9
10
11
12
13
14
3
1
6
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Filling the cannula
Filling the soft cannula with insulin is required after the infusion set is inserted into your body and the introducer needle is pulled out. The insulin amounts required to fill the cannula depend on the type of infusion set you are using. Refer to your infusion set instructions for this information. If you are using an infusion set with a needle, press ESC to skip this step.
If you do not complete the Fill Cannula steps, your pump triggers a FINISH LOADING alarm. If you need to skip the Fill Cannula step, press ESC to avoid getting this alarm.
1
After you have filled the infusion set tubing, the FILL CANNULA screen appears. It displays a message to connect the infusion set to your body. Press ACT to fill the cannula. To skip this step, press ESC until you see the MAIN MENU screen. If you do not complete this step, the RESERVOIR + SET MENU screen appears after 15 minutes. After 10 minutes, your pump triggers a FINISH LOADING alarm.
2
Enter the amount for your type of infusion set, then press ACT. To skip this step, press ESC until you see the MAIN MENU screen. If you do not complete this step, the RESERVOIR + SET MENU screen appears after one minute. After 10 minutes, your pump triggers a FINISH LOADING alarm.
3
As the cannula starts filling, the FILLING CANNULA screen will count up the units as they are delivered. The pump will beep or vibrate when the cannula is full.
To see how much insulin was delivered to fill the infusion set: 1
Go to the HISTORY screen.
Main > Reservoir + Set > History
2
Scroll through the list of insulin deliveries. The letter T at the end of the text line indicates that insulin was delivered to fill the tubing. The letter C at the end of the text line indicates insulin was delivered to fill the cannula. Exit the menus.
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Disconnecting Quick-set
The Quick-set allows you the freedom to temporarily disconnect from your pump without removing the infusion set from your body.
1
Hold the side grips of the connector part with your fingers.
2
Twist the connector counter-clockwise.
3
Remove the connector from the site.
12
3
Reconnecting Quick-set
Place the connector part (flat side facing down) on the infusion site until it is fully seated. Do not squeeze the connector part by the flat side grips.
12
3
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Record keeping for diabetes management
Now that you are using the pump, we will be asking you to test your blood glucose regularly. It is important to test often and write down your blood glucose readings, the food you eat, any exercise you perform and any other notes to explain your blood glucose results.
You must test at the recommended times and any other time that you feel your blood glucose is high or low. Be sure to include your meal boluses, correction boluses, the amount of carbohydrate you eat, basal rate and any other information that will be helpful in assisting your healthcare professional in adjusting your pump settings.
It is very important to look at your blood glucose readings as feedback regarding your diabetes management, not as statements about you or your self-worth. Try not to have an emotional reaction to the numbers and do not judge them too harshly. You will soon learn how to modify the numbers easily and precisely through insulin pump therapy.
Test at least four to six times per day. These are the recommended times to test to determine control:
Overnight (occasionally, at approximately 2:00 - 3:00 AM)
Pre-breakfast (fasting)
Post-breakfast (approximately two hours after eating)
Pre-lunch
Post-lunch (approximately two hours after eating)
Pre-dinner
Post-dinner (approximately two hours after eating)
Bedtime
Before driving
Determining your pump settings
Your healthcare professional will use your daily blood glucose journal records to program your pump. It is very important to keep good records during the first weeks after you start on pump therapy. Not only must you record your blood glucose readings, but it will be important to eat regularly scheduled meals and to keep your activity as consistent as possible.
Until you and your healthcare professional determine the pump settings that will work best for you, it is important to eat meals for which it is easy to count the carbohydrates. After your correct basal rate is determined, you will be able to experiment with varied food choices and amounts.
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After you and your healthcare professional are satisfied with your initial pump settings, you may begin to experiment with different food choices, meal times and exercise schedules.
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Using the Bolus Wizard feature
What is it?
Bolus Wizard is a feature that calculates an estimated bolus to support your food intake or to correct a high blood glucose. To use this feature, you need the following information:
Carbohydrate counting
You need to know which foods contain carbohydrates and how to count these.
Your blood glucose reading
You need to know your blood glucose (BG) reading. When using the Bolus Wizard feature, the pump can work with blood glucose meter powered by MWT1 technology to automatically receive your blood glucose reading. MWT1 is the wireless Radio Frequency (RF) technology that is used to transmit information from the meter to the pump. You can program your pump to automatically receive your BG reading from this meter. All meters referenced in this user guide are blood glucose meters supported by MWT1 technology. The Meter option section has more information. If you are not using this meter, you will manually enter your blood glucose.
Your personal Bolus Wizard feature settings
In addition to your blood glucose reading and/or your food entry, the Bolus Wizard feature uses personal settings that you program into the pump. (For instructions see the How to program the Bolus Wizard feature section in this chapter.)
carb units (grams or exchanges)
carb ratios (in carbohydrate grams/unit of insulin or insulin units/carb exchanges)
BG units (mg/dL or mmol/L)
insulin sensitivity
Meter
BG readings
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target blood glucose range
active insulin time (hours)
Get this information from your healthcare professional, and, for best results, talk to your healthcare professional before making any changes. Keep a record of your settings in the following Bolus Wizard feature settings table:
Bolus Wizard feature settings
Information Setting
Carb units: _____ grams or ____ exchanges Carb ratios:
Bolus Wizard feature uses this for your food bolus calculations.
If you count carbs: this ratio is the amount of carbohydrate grams covered by one unit of insulin.
range: 1–200 grams/unit
If you count exchanges: this ratio is the amount of insulin you need to cover one (carb) exchange.
range: 0.075–15.0 units/exchange
NOTE: Your carb ratios may vary throughout the day. Your
pump allows you to program up to eight different carb ratios.
#1: __________ #2: __________
#3: __________ (additional settings, if needed)
#4: __________
#5: __________
#6: __________
#7: __________
#8: __________
start time
(midnight)
BG units: (how you measure your blood glucose) _____ mg/dL or _____ mmol/L
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Bolus Wizard feature settings
Information Setting
Insulin sensitivity:
This ratio is used for your correction bolus calculations. This ratio is the BG units reduced by 1.0 unit of insulin.
range: 10–400 mg/dL/u or 0.5–22.2 mmol/L/u
NOTE: Your insulin sensitivity may vary throughout the day.
Your pump allows you to program up to eight different insulin sensitivities.
BG units reduced / 1 unit of insulin
#1: __________
#2: __________
#3: __________ (additional settings, if needed)
#4: __________
#5: __________
#6: __________
#7: __________
#8: __________
start time
(midnight)
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Bolus Wizard feature settings
Information Setting
BG Target range:
If your current blood glucose is above the BG Target range, the Bolus Wizard feature will calculate a correction dose. If your current blood glucose is below the BG Target range, the Bolus Wizard feature will calculate a negative correction and subtract it from your food bolus.
range: 60–250 mg/dL or 3.3–13.9 mmol/L
NOTE: Your pump will allow you to program up to eight
different BG Target ranges.
#1: __________ #2: __________
#3: __________ (additional settings, if needed)
#4: __________
#5: __________
#6: __________
#7: __________
#8: __________
start time
(midnight)
Active insulin time:
The Bolus Wizard feature uses this time to calculate the active insulin in your system (see the About active insulin section in this chapter). Use your healthcare professional's recommendation for the active insulin time that best represents the insulin type you use and your physiological insulin absorption rate.
range: 2-8 hours
Number of Hours: _____
How the Bolus Wizard feature works
1 If you want your current blood glucose to be factored in, enter your BG Reading.
automatically from the meter (refer to the Meter option section), or
manually by selecting the
button.
2
If you are going to eat, enter your food amount in grams or exchanges.
3
The Bolus Wizard feature will calculate a bolus for you. An ESTIMATE DETAILS screen will appear with your estimated total bolus amount.
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Bolus Wizard warnings
When using the Bolus Wizard feature, the pump may display a HIGH BG, LOW BG, and MAX BOLUS EXCEEDED warnings.
HIGH BG
If your blood glucose in the ENTER BG screen is above 250 mg/dL (13.9 mmol/L), the Bolus Wizard feature displays a HIGH BG warning. Read the instructions, then press ACT or ESC to clear the message. You can then continue programming to deliver your bolus.
LOW BG
If your blood glucose in the ENTER BG screen is below 70 mg/dL (3.9 mmol/L), the Bolus Wizard feature displays a LOW BG warning. Read the instructions, then press ACT or ESC to clear the message. You can then continue programming to deliver your bolus.
MAX BOLUS EXCEEDED
Bolus Wizard feature will not deliver more than the limit set for your maximum bolus. If the Bolus Wizard feature calculates a bolus amount that is larger than your max bolus limit setting, the message, MAX BOLUS EXCEEDED will appear. If this happens, do these steps:
1
In the MAX BOLUS EXCEEDED screen, press ACT to continue your bolus programming. The EST : MAX screen appears with the estimated and maximum bolus amounts. Continue to the next step.
If you do not want to continue, press ESC to cancel and the screen will return to the ENTER BG screen.
2
In the EST : MAX screen, press ACT again to continue your bolus programming.
3
The SET BOLUS screen appears with the maximum bolus amount flashing. Enter the bolus amount. This amount cannot be more than the max bolus amount. Press ACT.
4
The BOLUS DELIVERY screen appears showing the insulin units being delivered.
5
The pump will beep/vibrate after it has completed the insulin delivery.
How to program the Bolus Wizard feature
You need your personal settings from the Bolus Wizard feature settings table to setup the Bolus Wizard feature. Your Bolus Wizard feature settings are programmed in the EDIT SETTINGS screen.
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
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Once the settings are programmed, you do not have to program them again unless the values change. After you program one setting, the screen will automatically go to the next required setting. After you program all your settings, review them as described in this section to make sure they are set correctly.
Instructions for programming the Bolus Wizard feature settings are in the next paragraphs. Program your settings in the order described to make sure you program all the settings. If you have not completed setting up all of the required settings, MISSING INFO screen appears. It lists the required settings for this feature. You must program the listed settings before you can use the Bolus Wizard feature.
Turning on the Bolus Wizard feature
1 Go to the EDIT SETTINGS screen.
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
2
The EDIT SETTINGS screen appears with Wizard: Off selected. Press ACT.
3
The WIZARD ON/OFF screen appears. Select On, then press ACT.
4
The EDIT SETTINGS screen appears, showing that the wizard is now turned on. You are now ready to select your carb units.
Selecting the Carb units
The carb unit setting lets the pump know which way to count your carbohydrates (grams or exchanges).
1
Make sure the EDIT SETTINGS screen is open.
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
2
Select Carb Units, then press ACT.
3
The CARB UNITS screen appears. Select Grams or Exchanges, then press ACT.
4
The EDIT SETTINGS screen shows the carb units you selected. You are now ready to set your carb/ exchange ratios.
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Setting the Carb/Exch ratios
Your pump allows you to set up to eight Carb/Exch ratios because this ratio may vary throughout the day. Your healthcare professional may only have you program one or two carb ratios when you first start using the Bolus Wizard feature.
To set the Carb/Exch ratios: 1
Make sure the EDIT SETTINGS screen is open.
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
2
Select Carb Ratios, then press ACT.
If you use grams as your carb units: Carb ratio is the number of carb grams that are covered by
one (1.0) unit of insulin.
If you use exchanges as your carb units: Carb ratio is the number of insulin units that are needed
to cover one (1.0) carb exchange.
3
The SET CARB RATIO 1 (if you are using grams) or SET EXCH RATIO 1 (if using exchanges) screen appears. The default ratio flashes on the screen.
4
Set your first ratio, then press ACT. Carb ratio values are normally between 5-50 grams/u or 0.3-3.0 u/ exch. If your ratio value is outside the range, a warning message will appear on the screen. This message warns that the entered carb ratio is valid but outside the usual range. Press ESC to correct or ACT to continue.
The start time for your first ratio is midnight and cannot be changed.
5
The SET START TIME 2 screen appears. The dashes under the screen name flash. The first Carb Ratio or Exchange Ratio is now set.
If you do not need a second ratio, press ESC and skip to the next section. If you need to set up another ratio, follow steps 6 through 9.
6
In the SET START TIME 2 screen, enter the time of the day you want this ratio to become active.
7
Press ACT. The SET CARB RATIO 2 screen (if using grams) or SET EXCH RATIO 2 screen (if using exchanges) appears.
8
The default ratio flashes. Select your ratio.
9
Press ACT. The SET START TIME 3 screen appears. The second carb or exchange ratio is now set.
10
If you do not need to set up any more ratios, press ESC. If you need to set up more ratios, repeat steps 6 through 9 above for each ratio.
You are now ready to set up the BG units.
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Setting the BG units
You can select mmol/L or mg/dL as your Blood Glucose Unit (measurement type). You can also set these units in the Sensor and Capture Event menus.
1
Make sure the EDIT SETTINGS screen is open.
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
2
Select BG Units, then press ACT.
3
The BLOOD GLUCOSE UNITS screen displays. Select mmol/L or mg/dL, then press ACT.
4
The EDIT SETTINGS screen shows the BG units you selected. You are now ready to set your insulin sensitivity.
Insulin sensitivity
Your insulin sensitivity is the amount your blood glucose (BG) level is reduced by one unit of insulin. This value is used to calculate a suggested insulin dose to correct a high BG. Because this sensitivity may vary throughout the day, your pump lets you set up to eight sensitivity settings. Your healthcare professional may only have you program one or two insulin sensitivities when you first start using the Bolus Wizard feature. Record your settings in the Bolus Wizard feature settings table in this chapter.
Insulin sensitivity values are normally between 20–100 mg/dL/u (1.1–5.6 mmol/L/u). If your value is outside this range, a warning message will appear on the screen.
1
Make sure the EDIT SETTINGS screen is open.
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
2
Select Sensitivity, then press ACT.
3
The INS SENSITIVITY 1 screen appears. The default sensitivity value flashes on the screen.
4
Set the value for your first insulin sensitivity setting, then press ACT. The start time for your first insulin sensitivity is midnight and cannot be changed.
5
The SET START TIME 2 screen appears. The dashes under the screen name flash. The first insulin sensitivity is now set.
If you do not need a second insulin sensitivity, press ESC and skip to the next section. If you need to set up another insulin sensitivity, follow steps 6 through 9.
6
In the SET START TIME 2 screen enter the time of the day you want this insulin sensitivity to become active.
7
Press ACT. The INS SENSITIVITY 2 screen appears.
8
The default sensitivity value flashes. Select the value for this insulin sensitivity.
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9 Press ACT. The SET START TIME 3 screen appears. The second insulin sensitivity is now set. 10
If you do not need to set up any more insulin sensitivities, press ESC. If you need to set up more insulin sensitivities, repeat steps 6 through 9 above for each insulin sensitivity.
You are now ready to set up the BG Target.
Setting the BG Targets
The BG Target setting allows you to set glucose targets. The Bolus Wizard will use these targets to calculate a correction dose. Because the targets may vary throughout the day, your pump allows you to set up to eight BG Targets each day. If you want to set just one target value, instead of a range, set both the low and high values to the same number.
If your current BG is above the BG Target range, the Bolus Wizard feature may calculate a correction dose. The correction dose will deliver enough insulin to bring your BG down to your current high end of the BG Target range. If your current BG is below the BG Target range, the Bolus Wizard may calculate a negative correction and subtract it from your food bolus. This will bring your BG to the low end of the BG Target range.
Example:
Glucose Concentration
22.2
13.9
5.6
3.8
400
250
100
70
mmol/L mg/dL
Correct down to the upper limit of 100 mg/dL
Correct up to the lower limit of 70 mgl/dL
Targ et Range
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Pumps are sent from the factory with default BG Target range of 100–100 mg/dL (5.6–5.6 mmol/L).
1
Make sure the EDIT SETTINGS screen is open.
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
2
Select BG Target, then press ACT.
3
The TARGET RANGE 1 screen appears. The low end of your BG Target range flashes on the screen.
4
Set the BG Target, then press ACT.
5
The high end of your BG Target range flashes on the screen. Enter the BG Target, then press ACT. The start time for your first BG Target is midnight and cannot be changed.
6
a. If your BG Target is outside of 90–140 mg/dL (5.0–7.8 mmol/L), the pump screen displays a warning
that the values are acceptable but outside normal range. Press ESC to chan ge your BG T arge t or pr ess ACT to set this range.
b. If your BG Target is within 90–140 mg/dL (5.0–7.8 mmol/L), the SET START TIME 2 screen appears.
The dashes under the screen name flash. The first BG Target range is now set. If you do not need a second BG Target range, press ESC and skip to the next section. If you need to
set up another BG Target range, follow steps 7 through 11.
7
In the SET START TIME 2 screen enter the time of the day you want this BG Target range to become active.
8
Press ACT. The TARGET RANGE 2 screen appears.
9
The low end of your BG Target range flashes on the screen. Set the BG Target, then press ACT.
10
The high end of your BG Target range flashes on the screen. Enter the BG Target, then press ACT.
11
The SET START TIME 3 screen appears. The second BG Target range is now set.
12
If you do not need to set up any more BG Target ranges, press ESC. If you need to set up more BG Target ranges, repeat steps 7 through 11 above for each one.
You are now ready to set up the Active insulin time.
About active insulin
Active insulin is the bolus insulin that has already been delivered to your body, but has not yet been used. The pump considers your active insulin time setting in determining any active insulin still in your body from prior boluses. This may help prevent hypoglycemia caused by over-correcting for high blood glucose.
The pump shows the active insulin amount in the ESTIMATE DETAILS screen during the Bolus Wizard programming steps, the STATUS and the SET BOLUS screens. However, the active insulin amount is calculated differently in the ESTIMATE DETAILS screen and appears with an asterisk (*Active Insulin). The active insulin amount calculated in the Bolus wizard steps includes the insulin that has already been delivered and insulin that is going to be delivered by the active Square Bolus.
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Your Paradigm pump is shipped from the factory with an active insulin time setting of six hours, which most closely matches the published scientific data. If your healthcare professional prescribes a different time for you, the active insulin time setting can be adjusted in the Bolus Wizard menu in one-hour increments from two to eight hours.
For more details about active insulin, see the Bolus Wizard feature specifications section in the Pump specifications chapter.
CAUTION: If you give yourself insulin by using a syringe, the Bolus Wizard feature will not be able to correctly determine the active insulin in your system. Consult with your healthcare professional on how long you need to wait after a manual injection before you can rely on the active insulin calculation of your Bolus Wizard feature.
Active insulin time
The active insulin time setting lets the pump know which active insulin time to use in calculating the amount of active insulin to subtract before estimating a bolus. Your healthcare professional should determine the active insulin time that is best for you.
To set the Active insulin time, do the following steps: 1
Make sure the EDIT SETTINGS screen is open.
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
2
Select Active Ins Time, then press ACT.
3
The ACTIVE INS TIME screen appears. The default time of 6 hours flashes on the screen.
4
Set the number of hours for the active insulin time, then press ACT.
5
The EDIT SETTINGS screen shows the new Active insulin time setting. You have now completed the Bolus Wizard setup. Press ESC or wait to see the message: Bolus Wizard setup is complete.
Review your Bolus Wizard feature settings
Check your Bolus Wizard feature settings in the REVIEW SETTINGS screen. If necessary, compare this information with your information in the Bolus Wizard feature settings table.
1
Go to the REVIEW SETTINGS screen.
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Review Settings
2
Scroll through the text to view your Bolus Wizard settings.
3
Exit the menus when you are done.
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Normal bolus using Bolus Wizard feature
After the Bolus Wizard feature is turned on and programmed, this feature can calculate an estimate of insulin you need for your correction bolus and/or your food bolus. You have the option of using the estimate or changing it as necessary. Additionally, your pump can receive your blood glucose reading from the meter, if they are linked.
Use the button to deliver a Normal bolus at any time except during another Normal bolus. A Normal bolus will temporarily interrupt a Square Wave or Dual Wave bolus that is delivering. After the Normal bolus is
finished, the Square Wave or Dual Wave bolus delivery will resume.
NOTE: If you want to use the pump-to-meter link, make sure the meter option is on. Refer to the Meter
option section for instructions.
1 If you want a correction bolus, check your blood glucose with your blood glucose meter and go to step 2.
If you want to bolus for food, go to step 2.
2
Press on your pump, or go to the BOLUS MENU, select Use Bolus Wizard, and press ACT.
3
The ENTER BG screen will appear.
a. If you are not using the meter:
Enter your blood glucose value. Press ACT and continue to step 4. If you are not entering a blood glucose and want to bolus for food, select the dashes in the ENTER BG screen. The Bolus Wizard feature will calculate the insulin needed for your food entry without considering your blood glucose level. Press ACT and continue to step 4.
b. If you are using the meter, you must program your bolus within 12 minutes of the pump receiving
the reading from the meter. If more than 12 minutes have passed, the reading will no longer be available from the screen and you must enter your blood glucose manually.
Your pump checks if the entered BG is within your target range. Press ACT to accept the blood glucose value. You can also change this blood glucose value, if necessary, then press ACT.
4
The ENTER FOOD screen appears.
a. If this is a food bolus, enter the food value you will eat, then press ACT. b. If this is a correction bolus, select 0 (zero) as the value, then press ACT.
5
The ESTIMATE DETAILS screen appears. Review the information on this screen. If you need to make any changes, press ESC to return to the ENTER BG screen (step 3) and make changes as necessary.
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6 Press ACT in the ESTIMATE DETAILS screen. The SET BOLUS screen appears with the estimated bolus
amount flashing. Change the amount if desired. Press ACT to accept and start delivering your bolus.
NOTE: If you have BG Reminder turned On, the BG REMINDER DURATION screen displays. It allows you
to set the duration before you are reminded to check your blood glucose after a bolus. See the BG Reminder section in the Basic programming chapter for information about this feature.
7 The BOLUS DELIVERY screen appears. The pump will beep or vibrate at the start and end of the bolus.
As the bolus is delivered, the screen shows the bolus type and amount until the total units have been delivered. The screen then returns to the HOME screen.
Bolus Wizard feature examples
For the scenarios that follow, Michael has his Bolus Wizard feature turned on with the following settings:
Carb ratio: 15 grams per unit of insulin Insulin Sensitivity: 40 mg/dL (2.2 mmol/L) per unit of insulin
BG Target: 90–120 mg/dL (5.0–6.6 mmol/L)
Active Insulin Time: 6 hours
NOTE: If you want to see details of the formulas the Bolus Wizard feature uses to calculate estimate
boluses like the ones in the following examples, see the Bolus Wizard feature specifications section in the Pump specifications chapter.
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Example 1: Blood glucose on target (normal blood glucose) and no active insulin
Michael awakens in the morning before school and his mother has breakfast waiting for him. Before he begins eating, he tests his blood glucose with his meter and his blood glucose result of 120 mg/dL (6.6 mmol/L) is automatically sent to his pump.
He estimates that his meal consists of 60 grams of carbohydrates. When prompted by the Bolus Wizard feature, he enters this amount in the ENTER FOOD screen. Based on his Bolus Wizard feature settings, the pump will suggest that he take 4.0 units of insulin.
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 15 g/u = 4 units
Correction estimate:
Correction is 0 because the current BG reading is within the BG Target range.
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
4 units + 0 units = 4 units
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Example 2: Blood glucose above target (high blood glucose) and no active insulin
The next day, Michael wakes up before school. Before eating the same breakfast, he tests his blood glucose with his meter and finds it to be 200 mg/dL (11.1 mmol/L), which is above his target of 120 mg/dL (6.6 mmol/L). His blood glucose reading is automatically sent to his pump.
When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the ENTER FOOD screen. Based on his settings, the pump will suggest that he take 6.0 units of insulin.
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 15 g/u = 4 units
Correction estimate:
(Current BG - High BG Target) ÷ Insulin sensitivity = Units of insulin
(200 mg/dL - 120 mg/dL) ÷ 40 mg/dL/u = 2 units, or
(11.1 mmol/L - 6.6 mmol/L) ÷ 2.2 mmol/L/u = 2 units
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
4 units + 2 units = 6 units
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Example 3: Blood glucose below target (low blood glucose) and no active insulin
On another morning, Michael sits down before eating the same breakfast. He tests his blood glucose with his meter and finds it at 70 mg/dL (3.9 mmol/L), which is below his Low BG target of 90 mg/dL (5.0 mmol/L). His reading is automatically sent to his pump.
When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the ENTER FOOD screen. Based on his settings, the pump will suggest that he only take 3.5 unit of insulin.
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 15 g/u = 4 units
Correction estimate:
(Current BG - Low BG Target) ÷ Insulin sensitivity = Units of insulin
(70 mg/dL - 90 mg/dL) ÷ 40 mg/dL/u = -0.5 units, or
(3.9 mmol/L - 5.0 mmol/L) ÷ 2.2 mmol/L/u = -0.5 units
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
4 units + (-0.5) units = 3.5 units
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Example 4: Blood glucose above target (high blood glucose) with active insulin
Michael is at school and wants to eat a snack in the late morning. He tests his blood glucose with his meter and finds it at 200 mg/dL (11.1 mmol/L), which is above his target of 120 mg/dL (6.6 mmol/L). He estimates that his snack contains 60 grams of carbohydrate, so he enters 60 into the pump when prompted by the Bolus Wizard feature. Based on his settings, and as a result of 1.5 units of active insulin, his pump will suggest that he take 4.5 units.
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 15 g/u = 4 units
Correction estimate:
(Current BG - High BG Target) ÷ Insulin sensitivity - Active insulin = Units of insulin
(200 mg/dL - 120 mg/dL) ÷ 40 mg/dL/u - 1.5 units = 0.5 units, or
(11.1 mmol/L - 6.6 mmol/L) ÷ 2.2 mmol/L/u - 1.5 units = 0.5 units
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
4 units + 0.5 units = 4.5 units
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Example 5: Blood glucose below target (low blood glucose) with active insulin
Another day at school, Michael is getting ready to eat lunch. He tests his blood glucose with his meter and finds it at 70 mg/dL (3.9 mmol/L), which is below his Low BG target of 90 mg/dL (5.0 mmol/L). His reading is automatically sent to his pump.
When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the ENTER FOOD screen. Based on his settings, and despite 1.5 units of active insulin, his pump will suggest that he take 3.5 units of insulin.
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 15 g/u = 4 units
Correction estimate:
(Current BG - Low BG Target) ÷ Insulin sensitivity - Active insulin= Units of insulin
(70 mg/dL - 90 mg/dL) ÷ 40 mg/dL/u - 0* = -0.5 units, or
(3.9 mmol/L - 5.0 mmol/L) ÷ 2.2 mmol/L/u - 0* = -0.5 units
NOTE: *When the current BG is below the Low BG Target, an active insulin amount is not considered in
the Bolus Wizard feature calculations.
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
4 units + (-0.5) units = 3.5 units
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