Medtronic MiniMed Paradigm REAL-Time Revel User manual

Medtronic MiniMed Paradigm REAL-Time Revel User manual
User Guide
Paradigm® REAL-Time
Revel™ Insulin Pump
User Guide
©2009 Medtronic MiniMed, Inc. All rights reserved.
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.
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.
6025306-017_a
REF MMT-523 MMT-723 MMT-523K MMT-723K
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)
Bangladesh
Sonargaon Healthcare Pvt Ltd
Mobile: (+91)-9903995417
or (+880)-1714217131
België/Belgique:
N.V. Medtronic Belgium S.A.
Tel: 0800-90805
Brasil:
Medtronic Comercial Ltda.
Tel: +(11) 3707-3707
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Accu-Science LTD.
Tel: +353 45 433000
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Ravemma Ltd.
Tel: +371 7273780
España:
Medtronic Ibérica S.A.
Tel: +34 91 625 05 42
Fax: +34 91 625 03 90
24 horas: +34 901 120 335
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Medtronic Hungária Kft.
Tel: +36 1 889 0697
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Medtronic Europe S.A. Europe, Middle
East and Africa Headquarters
Tel: +41 (0) 21-802-7000
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Medtronic France S.A.S.
Tel: +33 (0) 1 55 38 17 00
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Medtronic Hellas S.A.
Tel: +30 210677-9099
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Medtronic International Ltd.
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Regional Office
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Medica Pacifica
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24-hr After-Hours:
+0800 633 487
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Medtronic (Shanghai) Ltd.
Tel: +86 40 0820 1981
or 80 0820 1981
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India Medtronic Pvt. Ltd
Tel: (+91)-80-22112245 / 32972359
Mobile: (+91)-9611633007
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Medtronic Norge A/S
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Fax: +47 67 10 32 10
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Medtronic Italia S.p.A.
Tel: +39 02 24137 261
Fax: +39 02 24138 210
Servizio assistenza tecnica: Nº verde
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POCCИЯ:
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24h: 8-800-200-76-36
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Medtronic of Canada Ltd.
Tel: 1-800-284-4416 (toll free/sansfrais)
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
Japan:
Medtronic Japan Co. Ltd.
Tel: +81-3-6430-2019
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Medtronic, Inc.
Tel: 1(305) 500-9328
Fax: 1(786) 709-4244
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Medtronic Poland Sp. Z.o.o.
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Medtronic Portugal Lda
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Fax: +351 21 7245199
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Medtronic Puerto Rico
Tel: 787-753-5270
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Medtronic Korea, Co., Ltd.
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Epsilon
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Medtronic International Ltd.
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or +65 6436-5090
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Tel: +386 1 542 51 11
Fax: +386 1 542 43 32
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Medtronic Slovakia O.Z.
Tel: +421 268 206 944
Fax: +421 268 206 999
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Swiss Biogenics Ltd.
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or (+94)-777256760
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Medtronic Finland Oy
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Help line: +358 400 100 313
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Medtronic AB
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Fax: +46 8 568 585 11
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Medtronic-Taiwan Ltd.
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Fax: +886.2.2501.7680
Toll Free: 0800.082.999
Thailand:
Medtronic (Thailand) Ltd.
Tel: +66 2 232 7400 ext 1
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
United Kingdom:
Medtronic Ltd.
Tel: +44 1923-205167
Yisrael:
Agentek
Tel: +972 3649 3111
Österreich:
Medtronic Österreich GmbH
Tel: +43 (0) 1 240 44-0
24 – Stunden – Hotline: 0820 820 190
Česká republika:
Medtronic Czechia s.r.o.
Tel: (+420-233) 059401
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.
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.
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 .................................................................................. 7
Sensor ..................................................................................................... 7
Adverse reactions .......................................................................................... 7
Notice .......................................................................................................... 8
Insulin pump and RF accessories ........................................................................ 8
RF interference from other devices ..................................................................... 9
Contents
vii
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
viii
Contents
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 ................................................... 46
Contents
ix
Chapter 4: Starting on insulin ............................................................ 47
Prepare your pump for use ................................................................................ 47
Setting up the reservoir .................................................................................... 48
Filling the reservoir ...................................................................................... 48
Changing your infusion set ................................................................................. 50
Removing the reservoir .................................................................................. 50
Rewinding your pump .................................................................................... 50
Inserting the reservoir in your pump .................................................................. 51
Filling the tubing ......................................................................................... 52
Inserting the infusion set ................................................................................ 53
Quick-set infusion set (with Quick-serter®) .......................................................... 55
Filling the cannula ....................................................................................... 55
Disconnecting Quick-set ................................................................................. 57
Reconnecting Quick-set ................................................................................. 57
Record keeping for diabetes management .............................................................. 58
Determining your pump settings .......................................................................... 58
Chapter 5: Using the Bolus Wizard feature ............................................ 61
What is it? .................................................................................................... 61
Carbohydrate counting .................................................................................. 61
Your blood glucose reading ............................................................................. 61
Your personal Bolus Wizard feature settings ......................................................... 61
How the Bolus Wizard feature works ..................................................................... 64
Bolus Wizard warnings ...................................................................................... 65
HIGH BG .................................................................................................... 65
LOW BG .................................................................................................... 65
MAX BOLUS EXCEEDED ................................................................................... 65
How to program the Bolus Wizard feature .............................................................. 65
Turning on the Bolus Wizard feature .................................................................. 66
Selecting the Carb units ................................................................................. 66
Setting the Carb/Exch ratios ........................................................................... 67
Setting the BG units ...................................................................................... 68
Insulin sensitivity ......................................................................................... 68
Setting the BG Targets .................................................................................. 69
About active insulin ...................................................................................... 70
Active insulin time ..................................................................................... 71
Review your Bolus Wizard feature settings ............................................................. 71
x
Contents
Meter option ................................................................................................. 72
Meter rules ................................................................................................ 72
Add, delete, review meter IDs ......................................................................... 73
Normal bolus using Bolus Wizard feature ................................................................ 73
Bolus Wizard feature examples ........................................................................... 75
Example 1: Blood glucose on target (normal blood glucose) and no active insulin ............ 75
Example 2: Blood glucose above target (high blood glucose) and no active insulin ........... 76
Example 3: Blood glucose below target (low blood glucose) and no active insulin ............ 77
Example 4: Blood glucose above target (high blood glucose) with active insulin .............. 78
Example 5: Blood glucose below target (low blood glucose) with active insulin ............... 79
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
Contents
xi
How does temp basal work? ............................................................................ 94
Temp basal types ......................................................................................... 95
Insulin rate (U/H) ...................................................................................... 95
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 ...................................................................................... 118
Preparing the sensor for communication .............................................................. 118
Calibrating the sensor ..................................................................................... 118
Entering meter BG for calibration ...................................................................... 119
Chapter 8: Using your sensor ........................................................... 121
Status screens .............................................................................................. 121
Reading the sensor glucose graphs ...................................................................... 122
Opening and viewing the graphs ...................................................................... 123
The graphs ............................................................................................... 124
Examples of real-time sensor glucose graphs ....................................................... 125
xii
Contents
3-hour graph .......................................................................................... 125
6-hour graph .......................................................................................... 126
12-hour graph ......................................................................................... 126
24-hour graph ......................................................................................... 127
How to check for rapid changes in sensor glucose ................................................... 128
The rapid change arrows ............................................................................... 128
How to make glucose alerts silent ...................................................................... 129
Calibration history ......................................................................................... 130
Sensor alert history ........................................................................................ 130
Using your system in water ............................................................................... 131
Chapter 9: Utilities ....................................................................... 133
Alarm review ............................................................................................... 133
Setting your alert type .................................................................................... 133
Auto-off ..................................................................................................... 134
LOW RESV WARNING (Low reservoir warning) ......................................................... 134
Review daily insulin totals ............................................................................... 135
Pump data management .................................................................................. 136
Insulin delivery information ........................................................................... 136
Sensor glucose information ............................................................................ 137
Meter blood glucose information ..................................................................... 138
AUC calculation ....................................................................................... 140
Personal reminders ........................................................................................ 142
Alarm clock .............................................................................................. 142
Remote control option .................................................................................... 142
Turn on remote control option ....................................................................... 143
Add, delete, review remote control IDs ............................................................. 143
Other Devices option ...................................................................................... 143
Block feature ............................................................................................... 144
Turning block on ........................................................................................ 144
Example 1: Block ........................................................................................ 144
Example 2: Block ........................................................................................ 144
Lock keypad feature ...................................................................................... 145
Locking the keypad ..................................................................................... 145
Unlocking the keypad .................................................................................. 145
Selftest ...................................................................................................... 145
User settings ................................................................................................ 146
Contents
xiii
Saving the settings ...................................................................................... 147
Restoring the settings .................................................................................. 147
Clearing the settings ................................................................................... 148
History .................................................................................................... 148
Chapter 10: Therapy management software ........................................ 149
CareLink® Personal Software ............................................................................ 149
Reports ................................................................................................... 149
Logbook ................................................................................................... 150
Chapter 11: 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 12: 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
What to do ............................................................................................... 158
Pump alert conditions ..................................................................................... 159
LOW RESERVOIR ......................................................................................... 159
xiv
Contents
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
MAX DELIVERY ........................................................................................... 167
MOTOR ERROR ........................................................................................... 167
NO DELIVERY ............................................................................................. 167
Contents
xv
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 13: Maintenance ................................................................ 171
Battery ...................................................................................................... 171
Storage ...................................................................................................... 172
Cleaning your pump ....................................................................................... 172
Cleaning the transmitter ................................................................................. 172
Cleaning the Sen-serter ................................................................................... 173
Chapter 14: 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
Delivery accuracy .......................................................................................... 178
Pump motor ................................................................................................ 178
Dual Wave bolus ........................................................................................... 179
xvi
Contents
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
Status screen ............................................................................................... 182
Bolus Wizard feature specifications .................................................................... 184
Bolus Wizard feature examples .......................................................................... 187
Insulin delivery default settings ......................................................................... 189
Bolus Wizard feature default settings .................................................................. 191
Sensor features default settings ......................................................................... 191
Guidance and manufacturer's declaration ............................................................. 195
Icon table ................................................................................................... 201
Appendix A: Sensor accuracy ........................................................... 203
Performance results in adults ........................................................................... 204
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
Contents
xvii
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
xviii
Contents
Introduction
Chapter 1
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
Introduction
1
•
•
•
•
•
•
•
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.
2
Introduction
Accessories
•
•
•
•
Chapter 1
•
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.
Introduction
3
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.
Meaning
Conventions
Press
to push and release the button
Hold
to push and keep pressure on the button
Select
to press
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
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
or
to highlight a screen item you want to select
or
buttons
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.
Go to the...screen.
Main > Utilities > Alarm
1
2
3
4
Introduction
From the MAIN MENU, select Utilities and press ACT.
In the UTILITIES MENU, select Alarm and press ACT.
The ALARM MENU appears.
User safety
Indications
Paradigm REAL-Time Revel insulin pump
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.
Chapter 1
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.
Meter
The Paradigm pump can be programmed to receive fingerstick blood glucose values transmitted from the
OneTouch® UltraLink® Meter or the BD Paradigm Link® 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.
Introduction
5
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 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.
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 our 24 Hour
HelpLine for further assistance.
6
Introduction
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.
Precautions
Chapter 1
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.
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
2
3
Avoid exposure of your pump and remote control to temperatures above 108°F (42°C) or below 34°F
(1°C).
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.
Do not steam, sterilize or autoclave your pump or remote control.
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.
Introduction
7
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.
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
2
8
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.
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.
Introduction
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
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.
Chapter 1
If you have questions, please contact the 24 Hour HelpLine.
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.)
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.
Introduction
9
10
Introduction
The basics
Your pump
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.
Chapter 2
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.
screen
battery
compartment
reservoir
window
tubing
connector
ESC
buttons
reservoir
compartment
The basics
11
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
2
3
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.
Use the edge of a coin to remove the battery cap. Turn the cap in a counter-clockwise direction.
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.
battery
battery cap
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.
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.
12
The basics
one half-turn
one half-turn
5
7
Chapter 2
6
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
HOME screen
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.
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.
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
EXPRESS
BOLUS
button
DOWN
button
ESC
button
ACT
button
The basics
13
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.
14
The basics
•
•
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
•
Use as a Shift button by pressing it in combination with another button to access certain
features.
to turn on backlight when in the menus.
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.
Chapter 2
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 screen, the MAIN MENU will appear.
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
The basics
15
Time display
24-Hr
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.
12-Hr
Time Display
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.
75 to 100% left
Less than 25% left
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.
Alert icon
Alarm icon
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.
16
The basics
Sensor is on and the pump
is receiving sensor data
Sensor is on but the pump
is not receiving sensor data
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
scroll bar
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.
Chapter 2
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.
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.
The basics
17
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.
18
The basics
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.
If a screen item is flashing (blinking), during programming, press
or
to change the value.
MAIN MENU
Chapter 2
Tip:
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.
The basics
19
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:
•
•
•
20
Last bolus insulin delivery
Current basal insulin delivery
The amount of active insulin, if any
The basics
•
•
•
•
•
•
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.
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:
•
•
•
Chapter 2
If you remove your pump
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.
The basics
21
22
The basics
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).
Chapter 3
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.
Basic programming
23
4
Change each of the settings as follows:
a. Hour
Change the hour. Press ACT.
For 12-hour setups, press
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.
24
Basic programming
until the correct A (am) or
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:
Chapter 3
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.)
Basic programming
25
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
2
3
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.
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.
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 70 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
26
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.
Basic programming
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
Bolus practice:
NOTE:
Chapter 3
Fred's lunch has a total of 4 carbohydrate exchanges so he will take a meal bolus of 4 units for his lunch.
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.
Basic programming
27
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).
28
Basic programming
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.
Jason is ready to eat his breakfast. He has calculated that he will need 4.0 units for his food.
Chapter 3
Meal bolus, correction bolus and insulin sensitivity
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 sensitivity1: 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.
Basic programming
29
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
30
Basic programming
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
carb value
BG value
Chapter 3
time
amount/type
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
Basic programming
31
•
•
delivered bolus amount
Bolus Wizard feature information (if used)
To see the details of any bolus, do these steps:
1
2
In the BOLUS HISTORY screen, select the bolus that you want to review and press ACT.
The details for that bolus will appear on the screen. Scroll through the details.
Without the Bolus Wizard feature
With the Bolus Wizard feature
delivery is active
If the Bolus Wizard feature
calculated your bolus, more
information will appear in the
BOLUS DETAIL screen.
delivery stopped
delivery completed
3
32
Exit when you are done.
Basic programming
Press the down key to see the
details
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
2
3
Go to the MAX BOLUS SETUP screen.
Main > Bolus > Bolus Setup > Max Bolus
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.
Your Max bolus is set. Exit the menus.
Example 1: Max bolus
Chapter 3
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
Basic programming
33
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.
2
3
Main > Bolus > Bolus Setup > Scroll Rate
The scroll rate value appears flashing. Change the value and press ACT.
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
2
34
Go to the BG REMINDER SETUP screen.
Main > Bolus > Bolus Setup > BG Reminder
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.
Basic programming
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.
Chapter 3
•
•
•
•
•
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:
2
Main > Utilities > Capture Option
Select On, then press ACT.
You will now have a Capture Event option in the MAIN MENU.
Basic programming
35
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.
2
3
Main > Capture Event > BG Units
Select either mg/dL or mmol/L, then press ACT. The CAPTURE EVENT menu shows.
You can now enter your BG reading.
To enter the BG measurement:
1
2
Make a note of the BG measurement.
Go to the ENTER BG screen.
Main > Capture Event > Enter BG
3
36
The ENTER BG screen flashes with dashes or the most recent meter BG measurement you entered.
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 69 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 69 for more information.
Basic programming
•
•
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 69 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 69 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.
Chapter 3
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
2
3
The ENTER INSULIN screen flashes with dashes or the insulin amount that you most recently entered.
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.
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.
Basic programming
37
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.
2
Main > Capture Event > Carb Units
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
2
3
4
5
Determine the total units of carbohydrates in the meal or snack that you plan to eat.
Go to the ENTER FOOD screen.
Main > Capture Event > Meal Marker
The ENTER FOOD screen flashes with dashes or with the number of carbohydrate grams or exchanges you
entered last time.
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.
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.
38
1
Follow the path below to save your exercise information:
2
3
Main > Capture Event > Exercise Marker
A message asks if you want to save this exercise.
Make your selection, then press ACT.
Basic programming
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
2
A message asks if you want to enter this marker.
Select Yes, then press ACT. Your pump saves your Other marker and returns to the CAPTURE EVENT
screen.
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:
2
Main > Capture Event > History
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.
Chapter 3
Viewing Capture Event history
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.
Basic programming
39
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
9:00 PM
Basal Rate 4
start time
rate 4
3:00 AM
Basal Rate 2
start time
rate 1
rate 2
24 hours
7:00 AM
Basal Rate 3
start time
rate 3
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.
40
Basic programming
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.
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.
Basic programming
Chapter 3
To set your basal rates:
41
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.
2
42
Main > Basal
Select Basal Review and press ACT.
Basic programming
3
If you do not use patterns, the STANDARD screen appears.
The delivery details for your standard basal will appear.
(24-hour total)
basal insulin
basal rate
start times
basal
delivery rates
(24-hour total)
basal insulin
Chapter 3
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
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.
Basic programming
43
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.
2
3
Main > Basal > Basal Setup > Max Basal Rate
Change the rate and press ACT.
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).
44
Basic programming
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
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.
Chapter 3
2
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.
Basic programming
45
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
2
3
4
5
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.
Now, RESUME delivery, so that your basal insulin will continue.
Check the STATUS screen.
How much insulin did the bolus deliver before you Suspended delivery? _______.
If you wanted to take the rest of the bolus later, how much would you take to equal 3.0 units? _______.
Practice:
Resume basal delivery after a suspend
Make sure you are NOT connected to your pump while practicing.
46
1
2
Give a 3.0 unit bolus now. While it is delivering, suspend the bolus.
Check here if you were able to suspend the bolus.
3
4
Now restart the pump.
Check here if you were able to restart the pump.
Basic programming
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
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.
Chapter 4
Before continuing with the steps in this chapter, we recommend that you watch your pump training CD-ROM
and complete your pump start training.
You will need these items:
•
•
•
•
Pump
Insulin (U100)
Paradigm reservoir and user guide
Paradigm compatible infusion set and user guide
Starting on insulin
47
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
1
3
reservoir
transfer
guard
vial
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.
4
48
Starting on insulin
5
6
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
12
Chapter 4
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.
13
14 Use your reservoir immediately after you fill it. Do not store it filled.
Starting on insulin
49
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.
3
4
5
tubing connector
half-turn counter-clockwise
Safely dispose of the used reservoir and infusion set item in a sharps container.
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.
50
Starting on insulin
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
2
3
If you removed your reservoir and are replacing it, go to the REWIND screen.
Main > Reservoir + Set > Reservoir Setup
In the REWIND screen, press ACT to start the rewind process. The REWINDING screen will appear while
the pump rewinds.
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.
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
Chapter 4
You must do these steps in the order described. If you are practicing, do NOT insert the reservoir in your
pump.
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.
Starting on insulin
51
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.
2
4
5
6
3
tubing connector
Attach the activity guard, if desired.
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.
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
2
3
52
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.
Press and hold ACT. The pump will beep six times indicating that the pump is positioning the reservoir.
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.
Starting on insulin
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.
4
Inserting the infusion set
Chapter 4
5
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.
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.
You can now insert the infusion set into your body as described in the next section.
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
Starting on insulin
53
•
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.
54
Starting on insulin
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.
1
2
3
5
6
7
8
9
10
11
12
13
Chapter 4
4
14
Starting on insulin
55
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
2
3
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.
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.
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
2
56
Go to the HISTORY screen.
Main > Reservoir + Set > History
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.
Starting on insulin
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
2
3
Hold the side grips of the connector part with your fingers.
Twist the connector counter-clockwise.
Remove the connector from the site.
1
2
3
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.
1
2
Chapter 4
Reconnecting Quick-set
3
Starting on insulin
57
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.
58
Starting on insulin
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.
Chapter 4
Starting on insulin
59
60
Starting on insulin
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
BG readings
Your personal Bolus Wizard feature settings
Chapter 5
You need to know your blood glucose (BG) reading. When using
the Bolus Wizard feature, the pump can work with blood glucose
Meter
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 in this chapter has more information. If you are not using this meter, you will manually
enter your blood glucose.
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
Using the Bolus Wizard feature
61
•
•
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.
#1: __________
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
#2: __________
start time
(midnight)
#3: __________
(additional settings,
if needed)
#4: __________
#5: __________
#6: __________
#7: __________
#8: __________
NOTE:
Your carb ratios may vary throughout the day. Your
pump allows you to program up to eight different carb ratios.
BG units: (how you measure your blood glucose)
62
Using the Bolus Wizard feature
_____ mg/dL or _____ mmol/L
Bolus Wizard feature settings
Information
Setting
Insulin sensitivity:
This ratio is used for your correction bolus calculations.
BG units reduced /
1 unit of insulin
This ratio is the BG units reduced by 1.0 unit of insulin.
#1: __________
range: 10–400 mg/dL/u or 0.5–22.2 mmol/L/u
#2: __________
NOTE: Your insulin sensitivity may vary throughout the day.
#3: __________
(additional settings,
if needed)
Your pump allows you to program up to eight different insulin
sensitivities.
start time
(midnight)
#4: __________
#5: __________
#6: __________
#7: __________
#8: __________
Chapter 5
Using the Bolus Wizard feature
63
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.
#1: __________
range: 60–250 mg/dL or 3.3–13.9 mmol/L
#4: __________
NOTE:
#5: __________
Your pump will allow you to program up to eight
different BG Target ranges.
#2: __________
start time
(midnight)
#3: __________
(additional settings,
if needed)
#6: __________
#7: __________
#8: __________
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.
Number of Hours: _____
range: 2-8 hours
How the Bolus Wizard feature works
1
2
3
64
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 in this chapter), or
button.
•
manually by selecting the
If you are going to eat, enter your food amount in grams or exchanges.
The Bolus Wizard feature will calculate a bolus for you. An ESTIMATE DETAILS screen will appear with
your estimated total bolus amount.
Using the Bolus Wizard feature
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
4
5
Chapter 5
2
3
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.
In the EST : MAX screen, press ACT again to continue your bolus programming.
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.
The BOLUS DELIVERY screen appears showing the insulin units being delivered.
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
Using the Bolus Wizard feature
65
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.
2
3
4
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
The EDIT SETTINGS screen appears with Wizard: Off selected. Press ACT.
The WIZARD ON/OFF screen appears. Select On, then press ACT.
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).
66
1
Make sure the EDIT SETTINGS screen is open.
2
3
4
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
Select Carb Units, then press ACT.
The CARB UNITS screen appears. Select Grams or Exchanges, then press ACT.
The EDIT SETTINGS screen shows the carb units you selected. You are now ready to set your carb/
exchange ratios.
Using the Bolus Wizard feature
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.
2
3
4
5
8
9
10
Using the Bolus Wizard feature
Chapter 5
6
7
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
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.
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.
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.
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.
In the SET START TIME 2 screen, enter the time of the day you want this ratio to become active.
Press ACT. The SET CARB RATIO 2 screen (if using grams) or SET EXCH RATIO 2 screen (if using exchanges)
appears.
The default ratio flashes. Select your ratio.
Press ACT. The SET START TIME 3 screen appears. The second carb or exchange ratio is now set.
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.
67
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.
2
3
4
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
Select BG Units, then press ACT.
The BLOOD GLUCOSE UNITS screen displays. Select mmol/L or mg/dL, then press ACT.
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.
2
3
4
5
6
7
8
68
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
Select Sensitivity, then press ACT.
The INS SENSITIVITY 1 screen appears. The default sensitivity value flashes on the screen.
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.
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.
In the SET START TIME 2 screen enter the time of the day you want this insulin sensitivity to become
active.
Press ACT. The INS SENSITIVITY 2 screen appears.
The default sensitivity value flashes. Select the value for this insulin sensitivity.
Using the Bolus Wizard feature
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.
mmol/L
22.2
mg/dL
400
13.9
250
5.6
100
3.8
70
Target Range
Correct down to the upper
limit of 100 mg/dL
Chapter 5
Glucose Concentration
Example:
Correct up to the lower limit
of 70 mgl/dL
Using the Bolus Wizard feature
69
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.
2
3
4
5
6
7
8
9
10
11
12
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
Select BG Target, then press ACT.
The TARGET RANGE 1 screen appears. The low end of your BG Target range flashes on the screen.
Set the BG Target, then press ACT.
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.
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 change your BG Target or press
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.
In the SET START TIME 2 screen enter the time of the day you want this BG Target range to become
active.
Press ACT. The TARGET RANGE 2 screen appears.
The low end of your BG Target range flashes on the screen. Set the BG Target, then press ACT.
The high end of your BG Target range flashes on the screen. Enter the BG Target, then press ACT.
The SET START TIME 3 screen appears. The second BG Target range is now set.
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.
70
Using the Bolus Wizard feature
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:
Make sure the EDIT SETTINGS screen is open.
2
3
4
5
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings
Select Active Ins Time, then press ACT.
The ACTIVE INS TIME screen appears. The default time of 6 hours flashes on the screen.
Set the number of hours for the active insulin time, then press ACT.
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
Chapter 5
1
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.
2
3
Main > Bolus > Bolus Setup > Bolus Wizard Setup > Review Settings
Scroll through the text to view your Bolus Wizard settings.
Exit the menus when you are done.
Using the Bolus Wizard feature
71
Meter option
BG readings
You can set up your pump to automatically receive your blood
glucose reading from the OneTouch® UltraLink® Meter or the BD
Meter
®
Paradigm Link Meter. Your pump is set at the factory with the
meter option turned off. See the Add, delete, review meter IDs
section in this chapter to turn the meter option on, and to enter
your meter ID. Programming your meter ID links your pump to the meter. Each meter has its own unique ID.
You can link up to three meters to your pump. If you do not link the meter to your pump, you must enter
your blood glucose readings manually.
When the pump is idle (at the HOME screen), it will beep or vibrate when it receives a blood glucose reading
from the meter. The reading will appear on the pump screen. If your BG reading is not within your set BG
Target range, the pump beeps three times. For BG readings that are above the set BG Target range, use the
Bolus Wizard feature to enter a correction bolus.
NOTE:
The use of RF (radio frequency) devices with the pump reduces pump battery life.
You have to turn on the meter option to add, delete or review the meter ID(s) programmed in your pump.
The meter ID is printed on the back of the meter. See the user guide that came with your meter for detailed
information on how to use it.
Meter rules
If you want your pump to communicate with the meter, the following conditions must apply:
1
2
3
4
5
The meter option must be turned on and programmed. Refer to the instructions in this section.
Your pump must be within 4 feet (1.2 meters) of your meter to receive the blood glucose reading.
The pump cannot have a LOW BATTERY alert condition.
When programming a bolus, the blood glucose measurement from the meter will appear as the default
blood glucose value on the ENTER BG screen. The pump will not display a reading that is older than 12
minutes on the ENTER BG screen.
Do not use the RF meter to send your blood glucose readings to the pump while onboard aircraft. Manually
enter your blood glucose.
CAUTION: The pump will not receive signals from the meter while it has a LOW BATTERY condition. To
ensure the meter communicates with the pump, make sure the pump does not have a low battery.
(Replacing the low battery with a new battery will restore meter-pump communication.)
72
Using the Bolus Wizard feature
Add, delete, review meter IDs
The meter programming screens are very similar to those for the remote control. Make sure to select Meters
in the DEVICE OPTIONS screen when programming your meter.
You have to turn on the meter option to add, delete, or review the meter ID(s) programmed in your pump.
To turn on the meter option:
1
2
3
Main > Utilities > Connect Devices > Meters
Select On, then press ACT. The METER ID MENU appears.
Add, delete or review your meter ID(s) as desired.
Adding meter IDs
a. Select Add ID, then press ACT.
b. Use the up and down arrow buttons to enter each of the six ID characters. Press ACT after each
entry.
c. After you set the last character of the ID, the screen will return to the METER ID MENU.
Deleting meter IDs
a. Select Delete ID, then press ACT.
b. Select the meter ID that you want to delete and press ACT.
c. The selected ID is now deleted.
Reviewing meter IDs
If you are not sure that your meter ID is entered in your pump, check the REVIEW METER ID screen.
a. Select Review ID, then press ACT.
b. The programmed IDs will show in the REVIEW METER ID screen.
Exit the menus when you are done.
Chapter 5
4
Go to the METER OPTION screen.
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.
Using the Bolus Wizard feature
73
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 in this chapter for instructions.
1
2
3
4
5
6
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.
on your pump, or go to the BOLUS MENU, select Use Bolus Wizard, and press ACT.
Press
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.
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.
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.
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
74
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.
Using the Bolus Wizard feature
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.
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.
Chapter 5
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
Using the Bolus Wizard feature
75
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
76
Using the Bolus Wizard feature
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
Chapter 5
Using the Bolus Wizard feature
77
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
78
Using the Bolus Wizard feature
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.
Chapter 5
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
4 units + (-0.5) units = 3.5 units
Using the Bolus Wizard feature
79
80
Using the Bolus Wizard feature
Optimizing pump therapy
Square Wave and Dual Wave bolus
Square Wave bolus delivers a bolus evenly over a period of time (30 minutes to 8 hours). This bolus can be
used for insulin delivery when you have eaten a long meal with extended snacking. It can also be useful if
you have delayed food digestion due to gastroparesis or meals high in fat. A Square Wave bolus can be useful
if a Normal bolus drops your blood glucose too rapidly. Since the Square Wave portion extends over a period
of time, the insulin is more likely to be available to match your individual needs.
NOTE:
During delivery of a Square Wave bolus, you will not be able to do the following pump functions:
change the max bolus amount, change the scroll rate, disable or deliver Dual and Square Wave boluses,
rewind or fill the cannula, change the active insulin time, run a self-test, or access the User Settings menu.
All other pump functions are still available during the Square Wave bolus.
Dual Wave bolus delivers a combination of an immediate Normal bolus followed by a Square Wave bolus.
The Square Wave portion is delivered evenly over a period of time. A Dual Wave bolus is useful for meals
with both rapidly and slowly absorbed carbohydrates. For example, a Dual Wave bolus would be appropriate
for fruit and crackers followed by pasta. The Dual Wave option meets both immediate and extended insulin
needs. A Dual Wave bolus is also useful for correcting elevated blood glucose before a meal.
Chapter 6
Optimizing pump therapy
81
See the following graphic for a description of the different bolus types:
INSULIN
Entire bolus amount
delivered immediately.
NORMAL
BOLUS
Bolus amount delivered evenly
over specified time period.
SQUARE WAVE
BOLUS
1
2
Part of the bolus amount delivered
immediately and the remainder
delivered evenly over time period.
DUAL WAVE
BOLUS
Now
Portion
3
Square
Portion
TIME
Turning on the Dual Wave/Square Wave option
It is important that you consult with your healthcare professional before using a Square Wave or Dual Wave
bolus. You should be familiar with the basic functions of your pump before exploring these options.
To set up a Dual Wave or Square Wave bolus, you must first turn on the dual/square bolus option.
1
Go to the DUAL/SQUARE OPTION screen.
2
Main > Bolus > Bolus Setup > Dual/Square Bolus
Select On, then press ACT. The feature is now on. Exit the menus.
Square Wave or Dual Wave bolus without Bolus Wizard feature
1
2
3
Make sure the dual/square option is on.
Calculate your food and/or correction bolus amount.
Go to the BOLUS TYPE screen.
on your pump, or follow this path:
Press
Main > Bolus > Set Bolus
82
Optimizing pump therapy
4
5
For
a.
b.
c.
For
a.
b.
a Square Wave bolus, do these steps:
Select Square Wave Bolus, then press ACT. The SET SQUARE BOLUS screen appears.
Enter the desired amount for the Square Wave bolus units, then press ACT.
Continue to step 5.
a Dual Wave bolus, do these steps:
Select Dual Wave Bolus, then press ACT. The SET DUAL BOLUS TOTAL screen appears.
Enter the desired amount for the total dual bolus units. This amount is the total of Normal and Square
Wave bolus units. Press ACT.
c. The next screen flashes the amounts of Now (Normal) and Square Wave portions of the Dual Wave
bolus. The screen also shows the percentage amount of each portion. Press
or
to change the
percentage/number of units. Continue to step 5.
The SQUARE DURATION screen appears. Enter the amount of time you want the Square Wave bolus to
last, then press ACT.
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.
6
The BOLUS DELIVERY screen appears with an open circle indicating that your pump is in Special mode.
The pump beeps/vibrates at the start of the bolus. During bolus delivery, the pump will return to the
HOME screen. The pump beeps/vibrates at the end of the bolus and the open circle disappears.
Chapter 6
Optimizing pump therapy
83
Square Wave bolus practice
Your target pre-meal blood glucose range is ______ to _______.
Check your pre-meal blood glucose. Are you within your target? _____ If yes, continue. If no, wait to try
the following test until your pre-meal blood glucose is within your target range:
TEST: Choose a meal that is high in fat (hot dogs, pizza, cheese enchiladas). Determine your meal bolus
amount. Set the Square Wave bolus to deliver the determined amount of insulin over two hours. (This
duration time is an example. As always, consult with your healthcare professional for guidance.)
Check your blood glucose and record:
Pre-meal ________
1 hour post meal ________
2 hours post meal ________
3 hours post meal ________
4 hours post meal ________
Did your blood glucose return to your pre-meal target within 4 hours post meal? ________
If yes, then repeat this test with the same meal on another day to verify your results.
If no, discuss this with your healthcare professional for guidance.
84
Optimizing pump therapy
Dual Wave bolus practice
Can you think of any meals where this feature would help you with blood glucose control?
Your target pre-meal blood glucose range is ______ to _______
Check your pre-meal blood glucose. Are you within your target? _____ If yes, continue. If no, try this test
when your pre-meal blood glucose is within your target range:
TEST: Choose a meal that has a combination of both rapidly absorbed and slowly absorbed carbohydrates.
Determine your meal bolus amount. Set the Dual Wave bolus to deliver the determined amount of insulin.
Program your pump to deliver one-half over 2-hours*, and the other half immediately.
(* This duration of time and ratio is an example. As always, consult with your healthcare professional for
guidance.)
Check blood glucose and record:
Pre-meal________
1 hour post meal________
2 hours post meal________
3 hours post meal________
4 hours post meal________
Did your blood glucose return to your pre-meal target within 4 hours post meal? ________*
If yes, repeat this test with the same meal on another day to verify results.
If no, discuss this with your healthcare professional for guidance.
If you are using the Bolus Wizard feature to calculate your Square Wave or Dual Wave bolus amounts, you
will be prompted to enter your blood glucose reading and/or the (gram or exchange) units you will eat. The
Bolus Wizard feature will use this input to calculate your suggested correction and/or food bolus amount. If
you do not want to use the Bolus Wizard feature estimate, you can change it.
Chapter 6
Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus
The Bolus Wizard feature must be turned on and the settings must be programmed (see the How to program
the Bolus Wizard feature section in the Using the Bolus Wizard chapter). Also, make sure the dual/square
option is turned on (see the Turning on the Dual Wave/Square Wave option section in this chapter).
Optimizing pump therapy
85
If you want to use the pump-to-meter link, make sure the meter option is on. Refer to the Meter option
section in the Using the Bolus Wizard feature chapter for instructions.
1
2
3
4
5
6
Go to the ENTER BG screen.
Press
on your pump, or use the following path:
Main > Bolus > Use Bolus Wizard
Enter your blood glucose value, then press ACT.
The ENTER FOOD screen appears. Enter your food, then press ACT.
The ESTIMATE DETAILS screen appears. Scroll down to review the information there. Press ACT to
continue to step 5.
If you need to make any changes, press ESC to return to the ENTER BG screen. Make changes as necessary.
The BOLUS EST screen appears with Normal Bolus, Square Wave Bolus, and Dual Wave Bolus options. If
your Bolus Wizard feature calculates that your bolus includes a portion to correct your high blood glucose,
the Square Wave Bolus option will not be available. This helps you to select a bolus type (Normal or Dual
Wave) that has an immediate delivery option to cover your high blood glucose.
To set a Square Wave bolus, do these steps:
a. In the BOLUS EST screen, select Square Wave Bolus, then press ACT.
b. The SET SQUARE BOLUS screen flashes the estimated bolus amount. Change the amount if needed.
Press ACT to accept the bolus amount.
To set a Dual Wave bolus, do these steps:
a. The SET DUAL BOLUS TOTAL screen flashes the estimated bolus amount. This amount is the total of
both the Normal and Square Wave bolus units. Change the amount if needed. Press ACT to accept
the bolus amount.
b. The next screen flashes the amounts of Now (Normal) and Square portions of the Dual Wave bolus.
The screen also shows the percentage amount of each portion. Press ACT to accept the Bolus Wizard's
or
to change these portions, then press ACT.
suggested portions. You can also press
The Bolus Wizard feature recommends splitting the food portion of your bolus 50/50 between the
Square and Now portions. The entire correction amount is always recommended to the Now portion.
In this example the NOW portion consists of half of the food insulin plus the correction amount less
the active insulin (1.5U + 2.5U - 1.5U). This gives 2.5U or 62% of total insulin of 4.0U. The Square
portion consists of the other half of the food insulin (1.5U), which is 38% of total insulin of 4.0U.
86
Optimizing pump therapy
7
The SQUARE DURATION screen appears. Enter the amount of time you want the Square Wave bolus to
last, then press ACT.
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.
8
Press ACT to accept and deliver the bolus. The BOLUS DELIVERY screen appears with an open circle
indicating that your pump is in Special Mode. The pump beeps or vibrates at the start of the bolus. During
bolus delivery, the pump returns to the HOME screen. If you want to see the progress of the delivery, press
ESC to see the STATUS screen. The pump beeps or vibrates at the end of the bolus, and the open circle
disappears.
Easy bolus
The EASY BOLUS button
allows a quick way to deliver a Normal bolus. You will preset the settings for
this feature in the EASY BOLUS OPTION screen in the BOLUS MENU. Your pump is sent from the factory with
the Easy Bolus feature set to off. If you want to use Easy Bolus, turn it on.
After you set up Easy Bolus, with each
press, you can increase the Normal bolus amount by a fixed amount,
called a step. Before you can deliver an Easy Bolus, you must set the amount in the EASY BOLUS ENTRY screen.
This amount equals the number of units of insulin for each step. The maximum number of steps can equal
up to your maximum bolus limit. When using vibrate mode, EASY BOLUS is limited to 20 steps or maximum
bolus, whichever comes first.
After you set your step amount, you can program your Easy Bolus. When you are in the HOME screen, each
the Easy Bolus amount increases by one step. You will hear a beep or feel a vibration for
time you press
each step increase. Each beep is a different tone. This makes it easy for you to count the beeps while you
are programming your Easy Bolus.
Chapter 6
Easy bolus setup
1
Go to the EASY BOLUS OPTION screen.
Main > Bolus > Bolus Setup > Easy Bolus
Select On/Set, then press ACT.
NOTE:
If you are using the remote control, the Easy Bolus must be set to on.
Optimizing pump therapy
87
Step value setup
You can set the step value from 0.1 to 2.0 units, or to the set maximum bolus limit of less than 2.0 units
(factory setting: 0.1). Set the step to a number that is convenient to use and easy to multiply.
Total # Steps = 4
Total # Button Presses = 4
4
Example:
2.0 unit Easy bolus with a step
amount set at 0.5 units
1 Step = 0.5 units
3
1 Step = 0.5 units
2
1 Step = 0.5 units
1
1 Step = 0.5 units
0
0
0.5
1.0
1.5
2
Total # Units
1
2
The EASY BOLUS ENTRY screen flashes the step value. Change the value, then press ACT. The step value
is the increment you will use for your Easy bolus.
The screen will return to the BOLUS MENU. Your step amount is now programmed and Easy Bolus is ready
to use. Exit the menus.
Delivering Easy Bolus
Practice using the Easy Bolus feature while looking at the pump screen as you count the beeps. This feature
only works from the HOME screen. After you are familiar with Easy Bolus, you can use the audible tones for
bolus delivery without having to look at the screen.
1
From the HOME screen, press
2
Press
. The SET EASY BOLUS screen appears with the single step value flashing.
the number of times needed for your bolus amount. Watch the amount change on the screen
with each press. The pump will vibrate or sound a different tone for each
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Optimizing pump therapy
press.
3
When your total bolus amount appears on the SET EASY BOLUS screen, press ACT. Listen/feel to count
the steps without looking at the screen.
For example: You need to deliver a 2.0 unit bolus, and your step size is set to 0.5. Each time you press
, the units increase by the step amount of 0.5 units. To deliver 2.0 units, you need to press the
button four times. (4 X 0.5 = 2.0) The screen will show 2.0 units.
NOTE:
For your safety, you cannot use the
to select the Easy Bolus values. Pressing
or ESC
will cancel the Easy bolus.
4
If this amount is correct, press ACT to start the Easy Bolus delivery. The BOLUS DELIVERY screen will
show the units being delivered. When the total bolus is finished, the pump will beep or vibrate.
If this amount is wrong, press ESC or
to start over. The pump will return to the HOME screen.
Example 1: Easy bolus
Alexander is a busy executive with an accounting firm. He wears his Paradigm pump on his belt and does
not want to take it off to give himself a bolus. Alexander can easily reach down and feel for the Easy Bolus
to give a bolus.
button
He previously programmed his pump to deliver an Easy Bolus in steps of 0.5 unit increments. From the HOME
screen, with each press of the
, the pump will sound a different tone so he can keep track of the number
of button presses.
He wants to give himself 2.0 units for a snack, so he will press
4 times (4 presses x 0.5 units/press =
2.0 units) and then press the ACT button. The pump counts back 4 beeps because he pressed
4 times.
He simply presses ACT to confirm the amount, and his pump delivers the 2.0 units.
Optimizing pump therapy
Chapter 6
When Alexander wants to be more discreet, or does not want his pump to beep in an important meeting,
he can set the pump to Vibrate mode and feel for vibrations rather than listening for the tones. (See the
Setting your alert type section in the Utilities chapter for details.)
89
Your turn: Easy bolus practice
The factory default setting for the Easy Bolus feature is 0.1 unit steps. You can change the step level as
necessary to a value that is more convenient for you to use and easier to multiply.
Give your next bolus by using the Easy Bolus feature on your pump.
Your step level is ________.
How many units did you give? _______
How many tones did you count? _______
It might be a good idea to look at your pump's screen to see the bolus amount as well as counting the steps
the first few times you try this until you become familiar and comfortable with the feature.
Missed Bolus Reminder
Missed Bolus Reminder feature helps you remember to give yourself a meal bolus. It triggers a MISSED BOLUS
alert if you do not deliver a bolus during the time periods that you set. Set these time periods for the meals
for which you want to receive a reminder. The pump is set at the factory with the Missed Bolus Reminder
feature turned Off.
Add, delete, and review bolus reminders
You have to turn on the Missed Bolus Reminder option to add, delete and review the programmed reminders.
90
1
Go to the MISSED BOLUS REMINDER screen.
2
Main > Bolus > Bolus Setup > Missed Bolus Reminder
Select On/Set, then press ACT.
Optimizing pump therapy
Add
You can set up to four Missed Bolus Reminders.
1
2
3
Select Add Reminder on the MISSED BOLUS REMINDER screen, then press ACT.
The Start Time flashes. Times can be entered in 30 minute increments. Set the Start Time, then press
ACT.
After this time is set, the End Time flashes. Set the End Time, then press ACT.
If you enter the same Start Time and End Time, you will get one Missed Bolus Reminder in a 24 hour
period. If you add a Missed Bolus Reminder with a start time earlier than the current pump time, you
will not get this Missed Bolus Reminder until the next day.
Delete
1
2
Select Delete Reminder on the MISSED BOLUS REMINDER screen and press ACT.
In the DELETE REMINDER screen, highlight the bolus reminder that you want to delete and press ACT.
Review
1
2
Select Review Reminders on the MISSED BOLUS REMINDER screen and press ACT.
Review your Missed Bolus reminders.
Basal patterns
The Basal Patterns feature is optional for pump users. You can set your pump to deliver a standard basal and
two additional basal patterns to meet your individual daily, weekly, or monthly needs. Keep a paper copy of
your programmed patterns with you at all times in case you need to reprogram your pump. To select and use
pattern A or pattern B, the patterns option must be turned on and programmed.
NOTE:
•
•
Standard pattern: Your normal basal that supports your usual day-to-day activity. When the Patterns
feature is off, the pump uses your standard basal pattern.
Pattern A/B: Basal pattern that supports activity levels that are not a part of your day-to-day routine,
but are normal in your lifestyle. Such activities could be a sport that you do once a week or a change in
your sleep pattern over the weekend, extended periods of higher or lower activity, or menses.
Optimizing pump therapy
Chapter 6
You may want to explore this option after you become familiar with the basic pump functions. It
is important that you consult your healthcare professional before using a pattern other than your standard
pattern.
91
Turning on the patterns
Your pump is set at the factory with the basal patterns feature turned off. After you turn on patterns, you
still have to program and select a pattern (A or B), as described in the next sections, before the patterns
feature is active. If you turn off the patterns feature, your pump will automatically select your standard
basal pattern.
1
Go to the PATTERNS OPTION screen.
2
Main > Basal > Basal Setup > Patterns
Select On, then press ACT. The patterns feature is now on. Exit the menus.
Programming a pattern
Your pump will keep your pattern settings even when the Patterns option is turned off. However, the patterns
feature must be on to program a basal pattern.
To program your patterns, do these steps:
1 Go to the EDIT BASAL screen.
Main > Basal > Basal Setup > Set/Edit Basal
2 Select the basal pattern you want to program, then press ACT.
3 The SET BASAL RATE 1 screen appears. The basal rate flashes, indicating that it can be changed. Set your
first rate, then 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 want to use the same rate for the whole day, press ESC and skip to step 10. If you want to program
another basal rate, follow steps 5 through 8.
5 In the SET START TIME 2 screen enter the time of the day you want this basal rate to become active.
6 Press ACT. The SET BASAL RATE 2 screen appears.
7 The previously set basal rate or dashes flash on the screen. Select the value for this basal rate.
8 Press ACT. The SET START TIME 3 screen appears. The second basal rate is now set.
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Optimizing pump therapy
9 If you do not need to set up any more basal rates, press ESC. If you need to set up more basal rates,
repeat steps 5 through 8 above for each rate.
10 After you press ESC, the BASAL RATE screen appears. The screen will show:
• the current basal pattern and basal rate,
• time it started, and
• the 24-hour basal total.
After you make changes to a pattern, the pump will use that pattern as the current basal. Make sure the
basal you want is selected in the SELECT PATTERN screen.
Select a pattern
Before you select a pattern to be active, make sure the Patterns feature is turned on. After your standard
pattern and/or pattern A or B are set, do these steps to select a pattern to be the active one:
1
Go to the SELECT PATTERN screen.
2
3
Main > Basal > Select Patterns
Select the desired pattern, then press ACT.
The screen will return to the BASAL MENU. Your basal pattern is now active. Exit the menus.
NOTE:
If pattern A or B is active, the pump is in Special mode. An open circle appears at the top of the
screen.
Example 1:
Basal patterns
Ken has had his insulin pump for about a month. He tests his blood glucose 4 - 6 times a day and records
his results in his logbook. He is happy with his glucose control during the week but on the weekends, he
noticed that he has to eat more food to prevent his blood glucose from running too low.
Chapter 6
Ken has realized that during the week while he is at work, he is very inactive and sits at a desk most of
the time. On the weekends, though, he is busy with yard work, running errands and playing with his kids.
He determines that he needs to have lower basal settings to receive less insulin during active times, such
as his weekend.
He can use the Basal Patterns feature to support his weekend change in activity. During the week, he can
set his pump to deliver in the standard setting, and on Saturday morning, he can switch over to Pattern A,
which he can set with lower basal rates for the weekend. On Monday morning, he can return his pump to
the Standard setting for his weekday insulin needs.
Optimizing pump therapy
93
Example 2:
Basal patterns
Cynthia has had diabetes for about 12 years and has been on her Paradigm pump for several weeks. Every
Monday, Wednesday and Friday, Cynthia goes on a 3 kilometer walk in the morning. To prevent
hypoglycemia on these days, she uses the patterns feature. For those days, she simply switches over to
Pattern A, which she has programmed with a lower set of basal rates. Before she learned to use the patterns
feature, she would have to eat more food throughout the day to keep her blood glucose at a safe level.
Cynthia has also noticed that a few days prior to menstruation, her blood glucose levels seem to rise,
requiring more insulin. She has programmed Pattern B on her Paradigm pump with higher basal rates for
this time. For her usual schedule, she uses the standard basal pattern.
Your turn:
Can you think of situations where you might require different basal rate settings on different days?
Temp basal rates
Temp basal should be used based on the guidance of your healthcare professional. This feature is useful to
manage blood glucose levels during unusual short-term activities or conditions. These conditions could be
an illness or physical activity.
A temporary basal rate allows an immediate short-term change to your basal insulin for a specified period
of time (30 minutes to 24 hours). This rate can be up to your Maximum basal rate setting. It offers an easy
way to immediately meet short-term insulin needs for temporary activities or situations. When your blood
glucose is temporarily high or low, a temp basal rate allows you to set a temporarily higher or lower basal
to accommodate your blood glucose. For ongoing periods of increased or decreased activity, the patterns
feature may be more suitable.
How does temp basal work?
During a temp basal delivery, all other basal programming is temporarily overridden. After the temp basal
delivery is completed, your pump will return to the programmed basal. A temp basal is delivered only once
and does not repeat. If you want another temp basal, you must program the temp basal again. This feature
may be useful to temporarily increase or decrease basal insulin during illness, exercise or similar unusual
situations.
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Optimizing pump therapy
Temp basal types
Based on your preference, you can select either Percent of Basal or Insulin Rate.
Insulin rate (U/H)
Insulin rate is a fixed basal in units per hour (U/H). This temp basal type is independent of your current basal.
When you select Insulin rate (U/H) for your temp basal type, your pump will deliver the fixed amount you
have set for the duration as set. The amount of your temp basal insulin rate can be set up to your Maximum
basal rate setting.
If you make changes to your normal basal rate, your U/H temp basal is not affected and will continue to
deliver as programmed.
Temp Basal Settings
Temp basal type: Insulin rate (U/H)
Duration: 4 hours (1:05 p.m.-5:05 p.m.)
Rate: 1.25 U/H
1.25 U/H
temp basal rate
1.50 U/H
(rate 1)
7:00 a.m.
(7:00)
2.55 U/H
(rate 2)
1.25 1.25
U/H U/H
1.95 U/H
(rate 3)
12:00 a.m.
(00:00)
1:05 p.m.
(13:05)
Chapter 6
3:00 p.m.
(15:00)
5:05 p.m.
(17:05)
Optimizing pump therapy
95
Percent of basal
Unlike insulin rate, the percent of basal is dependent on your current basal rates. Percent temp basal is a
percentage of your current basal (0–200 percent limited to your Maximum basal rate setting). The temp basal
amount is rounded down to the next 0.025 or 0.05 U/H increment based on the basal rate.
The maximum percent limit is based on the largest basal rate segment with your programmed temp basal
rate time.
For example: It is 6:00 AM and your current basal rate is 1.50 U/H. You want to set a temp basal rate of
130 percent for seven hours. The maximum percent temp basal rate you can set is 125 percent. Anything
larger would make #2 segment exceed your Maximum basal setting of 2.0 U/H.
Your current basal rates:
Your Maximum basal rate setting: 2.0 U/H
Segment #1: 12:00A
1.50 U/H
Segment #2: 11:00A
1.60 U/H (largest)
Segment #3: 4:00P
1.30 U/H
If your current basal changes (for example, from rate 1 to rate 2), your percent temp basal amount will also
change. The pump will deliver the percentage for the duration that you have set.
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Optimizing pump therapy
You cannot make changes to your normal basal rate while a percent temp basal is active. You must either
wait until the temp basal is finished or cancel the temp basal in order to reprogram your normal basal rate
setting(s).
Temp Basal Settings
Temp basal type: Percent of basal
Duration: 4 hours (1:05 p.m. - 5:05 p.m.)
Rate: 50%
(50% x rate 2 = 1.275)
1.275 rounded down to
the next 0.05 increment is
1.25 U/H
(50% x rate 3 = 0.975)
0.975 rounded down to
the next 0.05 increment
is 0.95 U/H
2.55 U/H
(rate 2)
1.50 U/H
(rate 1)
1.25 0.95
U/H U/H
7:00 a.m.
(07:00)
1:05 p.m.
(13:05)
1.95 U/H
(rate 3)
12:00 a.m.
(00:00)
temp basal start time
3:00 p.m.
(15:00)
Optimizing pump therapy
Chapter 6
5:05 p.m.
(17:05)
temp basal stop time
97
Selecting temp basal type
Your pump will remember the temp basal type setting. Once the type is set, you do not have to set it again.
To select a temp basal type, do these steps:
1
2
3
Go to the SET TEMP BASAL AS screen.
Main > Basal > Basal Setup > Temp Basal Type
The SET TEMP BASAL AS screen appears. Select Insulin Rate (U/H) or Percent of Basal, then press
ACT.
The screen will return to the BASAL SETUP screen. The temp basal type is now set. Exit the menus.
If you select Percent of Basal as your temp basal type, changes to your basal rate are not allowed until
after temp basal is completed or cancelled.
Delivering a temp basal
A temp basal cannot exceed your programmed Max basal rate.
1
2
3
4
5
98
Go to the BASAL MENU.
Main > Basal
Select Set/Edit Temp Basal, then press ACT.
The SET DURATION screen appears. The duration will flash. Duration is the amount of time it will take
for the pump to deliver the temporary basal. Enter the desired minutes or hours (30 minutes to 24 hours),
then press ACT.
If you have selected insulin rate as your temp basal type, the SET TEMP BASAL U/H screen appears. If
you have selected percent of basal as your temp basal type, the SET TEMP BASAL % screen appears. The
temporary basal rate will flash. Enter your temp basal rate, then press ACT.
The BASAL MENU screen appears with an open circle at the top of the screen. Your pump is in Special
mode; temp basal is now set and delivering. Exit the menus.
Optimizing pump therapy
Verifying temp basal delivery
Temporary basal information is available in the STATUS screen only.
During a temporary (temp) basal, the pump is in Special mode (an open circle appears). This open circle will
remind you that a temp basal is active. Additionally, your pump will beep/vibrate three times every hour
during delivery. During delivery, go to the STATUS screen to see the current temp basal information.
Temp Basal of
0.6 units per hour
is now active
Temp Basal delivery
will last 30 minutes
4 minutes remaining
before Temp Basal
delivery is finished
Press down button
to scroll
Regular programmed
basal rate will
resume after the
Temp Basal delivery
is finished
Canceling a temp basal
Use the Cancel Temp Basal function in the BASAL MENU to cancel a temporary basal. This function
immediately stops the temp basal and resumes the regular programmed basal delivery.
1
2
Go to the BASAL MENU.
Main > Basal
Select Cancel Temp Basal, then press ACT.
The screen will return to the BASAL MENU. Your temp basal is cancelled and open circle has disappeared
from the top of the screen. The programmed basal is now active again. Exit the menus.
Optimizing pump therapy
Chapter 6
To cancel a temp basal, do these steps:
99
Example 1:
Temp Basal for a decreased temporary basal rate
Ramon and his friends got together for an unplanned game of soccer. Before using the pump, he was taking
shots to manage his diabetes. Ramon experienced frequent low blood glucose reactions sometimes during,
and very often after, he played games with his friends. Now that he is using his Paradigm pump, he can
use the Temporary Basal Rate feature to help prevent low blood glucose. He simply programs his pump to
temporarily deliver less basal insulin during the time that he is playing, and often for several hours after
play, as well.
Ramon was able to determine how to set his Temporary Basal rates by frequent blood glucose testing, both
during and after activity, and recording his results. The first time he tried using the pump, his healthcare
professional advised him to program his pump to deliver one-half of his usual basal rate for the amount of
time that he was playing and for an hour after he was done. He made small adjustments of the temporary
basal rate and the duration of time, each time he tried to use the feature. After several different attempts
with similar activity for the same amount of time, (such as his soccer game that lasted two hours), he
found a temporary basal rate that worked well for him.
Example 2:
Temp Basal for an increased temporary basal rate
Gail has had a cold with a cough for a couple of days. Because she is not feeling well, she tests her blood
glucose more frequently. She finds that her blood glucose levels are running above target range before
meals and she has needed several correction boluses to keep her blood glucose levels within her normal
limits. Gail decides to use the Temporary Basal Rate to increase her basal rate during the day today. As
advised by her healthcare professional, she will continue to check her blood glucose more frequently until
she is feeling well.
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Optimizing pump therapy
Your turn:
Think of an activity where you might need to use a Temporary Basal Rate.
At what rate is your current basal rate running? ____________
What Temporary Basal Rate would you try using at this time? ___________________
How long will you be active?___________________
What duration will you set for the Temporary Basal Rate?________________
Test your blood glucose before and during activity and several times after as well. What are your blood
glucose results?
Pre-activity______________
During activity______________
1 hour after activity______________
Several hours after activity______________
What Temporary Basal Rate changes will you make for the next time you try this?
Chapter 6
Optimizing pump therapy
101
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Sensor features
The optional sensor and transmitter can provide continuous glucose measurements to help you control your
glucose levels better. The sensor measures the glucose levels in the fluid under your skin. The transmitter
receives this measurement from the sensor and sends it wirelessly to the pump. To take advantage of your
pump sensor features, call 800-646-4633, +1-818-362-5958 (outside U.S.), or visit our web site at
www.medtronicdiabetes.com to purchase your sensor and transmitter.
The sensor glucose and meter blood glucose measurements are not identical. To see the accuracy of the
sensor glucose measurements, see the Sensor accuracy appendix.
Entering your sensor settings
Enter your pump sensor settings in the order they appear below, as some of the settings are dependent upon
other settings being made first. When you complete each setting, your pump will automatically display the
screen for the next setting in the sequence. When a screen item flashes, you may change the value of the
or
.
flashing item by pressing
Turning on the sensor
The sensor must be turned on, started and initialized to report glucose measurements.
1
Go to the EDIT SETTINGS screen.
Main > Sensor > Edit Settings
2
3
Sensor features
Chapter 7
The EDIT SETTINGS screen appears with Sensor: Off selected.
Press ACT. The SENSOR ON/OFF screen appears.
Select On, then press ACT. The EDIT SETTINGS screen appears showing the sensor is now turned on.
You are now ready to turn on the glucose alerts.
103
Turning on the Glucose Alerts
The Glucose alerts must be turned on if you want the system to send you an alert when the sensor glucose
measurements reach or exceed your Glucose Limits. For a Low sensor glucose alert, the pump plays four
consecutive tones, in falling pitch, if an audible beep has been selected as the alert type. For a High sensor
glucose alert, the pump plays four consecutive tones, in rising pitch, if an audible beep has been selected
as the alert type.
1
Make sure the EDIT SETTINGS screen is open.
2
3
Main > Sensor > Edit Settings
Select Glucose Alerts, then press ACT. The GLUCOSE ALERTS screen appears.
Select On, then press ACT. The EDIT SETTINGS screen appears showing the glucose alerts are now turned
On.
Setting the Glucose Limits
If you turned the Glucose alerts On, then you need to set the high and low Glucose Limits recommended by
your healthcare professional. Your recommended glucose limits may vary throughout the day, so your pump
allows you to set up to eight pairs.
A Glucose Limit pair includes one High Glucose Limit and one Low Glucose Limit, as shown in the following
table:
Glucose Limit pair
104
Alerts
Low: 80 mg/dL (4.4 mmol/L) for
523/723
90 mg/dL (5.0 mmol/L) for
523K/723K
A Low Glucose Limit alert occurs when the sensor glucose
measurement reaches or goes below the Low Glucose Limit in this
table.
High: 240 mg/dL (13.3 mmol/L) for
523/723
280 mg/dL (15.5 mmol/L) for
523K/723K
A High Glucose Limit alert occurs when the sensor glucose
measurement reaches or goes above the High Glucose Limit in this
table.
Sensor features
Selecting the BG units
You must select the blood glucose units (BG Units) for the system (either mmol/L or mg/dL). All BG
measurements will show in the BG unit type you select.
1
Make sure the EDIT SETTINGS screen is open.
2
3
4
Main > Sensor > Edit Settings
Select BG Units, then press ACT. The BLOOD GLUCOSE UNITS screen shows mg/dL and mmol/L.
Select your BG units.
Press ACT. The EDIT SETTINGS screen shows the BG Units type you selected.
You are now ready to set up your glucose limits.
Chapter 7
Sensor features
105
Setting the Glucose Limits start time
If your healthcare professional recommends that you set more than one pair of Glucose Limits, you must
enter a start time for each. For example, you may use one pair of Glucose Limits during the day and another
pair at night. The example below shows two pairs of Glucose Limits. The first pair begins at midnight, and
the second pair begins at 9:00 AM.
12:00 AM
12:00 AM
9:00 AM
Glucose Limits 1
High Glucose Limit:
240 mg/dL (13.3 mmol/L)
Low Glucose Limit:
60 mg/dL (3.3 mmol/L)
12:00 AM - 9:00 AM
(9 hours)
Glucose Limits 2
High Glucose Limit:
250 mg/dL (13.9 mmol/L)
Low Glucose Limit:
80 mg/dL (4.4 mmol/L)
9:00 AM - 12:00 AM
(15 hours)
To set up your Glucose Limits:
1 Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Edit Settings
2 Select Glucose Limits, then press ACT. The SET GLUCOSE LIMITS 1 screen appears. The Low Glucose
Limit flashes 80 mg/dL (4.4 mmol/L).
The start time for your first pair of Glucose Limits is midnight and cannot be changed.
3 Select your Low Glucose Limit. For the 523 and 723 pumps, the value must be between 40 and 390 mg/dL
(2.2 and 21.6 mmol/L). To switch off the Low Glucose Limit, reduce it below 40 mg/dL (2.2 mmol/L) to
select OFF. For the 523K and 723K pumps, the value must be between 90 and 390 mg/dL (5.0 and
21.6 mmol/L). To switch off the Low Glucose Limit, reduce it below 90 mg/dL (5.0 mmol/L) to select
OFF.
4 Press ACT to select your High Glucose Limit. For the 523 and 723 pumps, the screen flashes 240 mg/dL
(13.3 mmol/L). The limit you select must be between 50 and 400 mg/dL (2.8 and 22.2 mmol/L). Your
High Glucose Limit must also be at least 10 mg/dL (0.6 mmol/L) above your Low Glucose Limit. To switch
off the High Glucose Limit, reduce the High Glucose Limit below 50 mg/dL (2.8 mmol/L) to select
OFF. For the 523K and 723K pumps, the screen flashes 280 mg/dL (15.5 mmol/L). The limit you select
106
Sensor features
5
6
7
8
9
10
11
must be between 100 and 400 mg/dL (5.6 and 22.2 mmol/L). Your High Glucose Limit must also be at
least 10 mg/dL (0.6 mmol/L) above your Low Glucose Limit. To switch off the High Glucose Limit, reduce
the High Glucose Limit below 100 mg/dL (5.6 mmol/L) to select OFF.
Press ACT. The SET START TIME 2 screen appears. The dashes under the screen name flash. The first pair
of Glucose Limits is now set.
If you do not need a second pair of Glucose Limits, press ESC and skip to the next section. If you want
to set up a second pair of Glucose Limits, follow steps 6 through 11 below.
To set a second pair of Glucose Limits, select the time of day you want this pair to become active.
Press ACT. The SET GLUCOSE LIMITS 2 screen appears. The default Low Glucose Limit flashes (OFF).
Select your Low Glucose Limit. For the 523 and 723 pumps, the value must be between 40 and 390 mg/dL
(2.2 and 21.6 mmol/L). For the 523K and 723K pumps, the value must be between 90 and 390 mg/dL
(5.0 and 21.6 mmol/L).
Press ACT. The default High Glucose Limit flashes (OFF).
Select your High Glucose Limit. For the 523 and 723 pumps, the value must be between 50 and 400 mg/dL
(2.8 and 22.2 mmol/L). For the 523K and 723K pumps, the value must be between 100 and 400 mg/dL
(5.6 and 22.2 mmol/L).
Press ACT. The SET START TIME 3 screen appears.
The second pair of Glucose Limits (Glucose Limits 2) is now set. If you do not need any more Glucose
Limits pairs, press ESC. If you want to set more Glucose Limits, then repeat steps 6 through 11 above
for each pair, up to a maximum of eight.
You are ready to set up your High Repeat.
Setting the High Repeat
After you receive and clear a High Glucose, Rise Rate of Change, or High Predictive alert, the alert will repeat
until the condition that has caused the alert is resolved. The High Repeat feature allows you to set how
frequently you want the alert to repeat after you clear it the first time. For example, if your blood glucose
levels usually take one to two hours to fall after a correction bolus, you may want to set the High Repeat to
one or two hours to avoid unnecessary alerts.
Chapter 7
Sensor features
107
Example
You set your High Repeat to 15 minutes. You receive an alert at 1:00 PM and immediately clear it. However,
the condition that caused the alert still exists, so you will receive a second alert at 1:15 PM, 15 minutes after
you cleared the first alert. If you immediately clear the alert again, then the alert will repeat at 1:30 PM
and continue to repeat every 15 minutes until you resolve the condition that caused the alert. (This example
also applies to the Low Repeat.)
To set up your High Repeat:
1
2
3
4
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Edit Settings
Select Hi Repeat, then press ACT. The SET HI ALERT REPEAT screen flashes the default High Repeat time
of 1 hour (1:00).
Select your High Repeat time. The time must be between 5 minutes (0:05) and 3 hours (3:00).
Press ACT. The EDIT SETTINGS screen shows the High Repeat value set.
You are now ready to set up your Low Repeat.
Setting the Low Repeat
After you receive and clear a Low Glucose, Fall Rate of Change, or Low Predictive alert, the alert will repeat
until the condition that caused the alert is resolved. The Low Repeat feature allows you to set how frequently
you want the above alerts or alarm to repeat after you clear it the first time. The Low Repeat feature works
similar to the High Repeat one. See Setting the High Repeat section in this chapter for an example.
1
2
3
4
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Edit Settings
Select Low Repeat, then press ACT. The SET LO ALERT REPEAT screen flashes the default Lo Alert Repeat
time of 20 minutes (0:20).
Select your Low Repeat time. The time must be between 5 minutes (0:05) and 1 hour (1:00).
Press ACT. The EDIT SETTINGS screen shows the Low Repeat value set. You are now ready to set up the
Predictive Alert.
Setting the Predictive glucose alert
The Predictive alerts calculate when you may reach your Low or High Glucose Limits, then send you an alert
before you reach those limits. A Predictive alert tells you that if your sensor glucose measurements keep
falling or rising at the current rate, you may reach your Glucose Limit in the number of minutes you selected.
108
Sensor features
For a LOW PREDICTED alert, the pump plays three consecutive tones, in falling pitch, if an audible beep has
been selected as the alert type. For a HIGH PREDICTED alert, the pump plays three consecutive tones, in
rising pitch, if an audible beep has been selected as the alert type.
Understanding the Time Sensitivity Settings
To use the Predictive alerts, you need to first set your Low or High Glucose Limits, and then your Time
Sensitivities. Time Sensitivity means the length of time, in minutes, you want to be notified before you reach
your High or Low Glucose Limit. If you set the Low time sensitivity setting at 25 minutes and the High time
sensitivity setting at 20 minutes, then the Predictive alerts will be sent:
•
•
25 minutes before the sensor glucose reaches your Low Glucose Limit
20 minutes before the sensor glucose reaches your High Glucose Limit
To set up the Predictive alerts:
1
2
3
4
5
6
7
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Edit Settings
Select Predict Alerts, then press ACT. The PREDICTIVE ALERTS LOW/HIGH screen shows that the alerts
are turned Off.
Select On, then press ACT. The SET TIME SENSITIVITY LOW/HIGH screen appears and the LOW time
setting flashes the default time: 15 minutes (0:15).
Select the Time Sensitivity (how many minutes before you reach your Low Glucose Limit). To turn off
the Low Predictive Alert, reduce the Time Sensitivity to OFF.
• Range: 5 to 30 minutes (0:05 to 0:30)
• Increments: 5 minutes
Press ACT. The HIGH time setting flashes the default time: 15 minutes (0:15).
Select the Time Sensitivity (how many minutes before you reach your High Glucose Limit). To turn off
the High Predictive Alert, reduce the Time Sensitivity to OFF.
• Range: 5 to 30 minutes (0:05 to 0:30)
• Increments: 5 minutes
Press ACT. The EDIT SETTINGS screen appears.
You are now ready to set up the rate alerts.
Chapter 7
Sensor features
109
Setting the Rate of Change Alerts
The Rate of Change alerts tell you when your sensor glucose (SG) changes at, or faster than, the per-minute
rate pre-selected by you. There are two alerts:
•
•
FALL RATE for SG decreases at or faster than your pre-selected rate. The pump plays two consecutive
tones, in falling pitch, if an audible beep has been selected as the alert type.
RISE RATE for SG increases at or faster than your pre-selected rate. The pump plays two consecutive
tones, in rising pitch, if an audible beep has been selected as the alert type.
You can set one or both Rate of Change alerts. The rate of change alert default setting is OFF. When you press
or
, 4.0 mg/dL (0.220 mmol/L) displays. This value changes up or down with each additional press.
The explanation in the following table shows how the Rate alerts work.
Then
If you set the number
Lower than 4.0 mg/dL/min
(0.220 mmol/L/min)
•
•
The system is more sensitive to SG changes
Alerts are more frequent than if you use a higher number
Higher than 4.0 mg/dL/min
(0.220 mmol/L/min)
•
•
The system is less sensitive to SG changes
Alerts are less frequent than if you use a lower number
To set up the Rate of Change alerts:
1
2
3
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Edit Settings
Select Rate Alerts, then press ACT. The SET FALL RATE LIMIT screen flashes the rate alert default setting:
OFF.
Select the Fall Rate Limit.
•
Range:
mg/dL/min
from 1.1 to 5.0
•
4
5
6
110
Increments:
mmol/L/min
from 0.065 to 0.275
mg/dL/min
0.1
mmol/L/min 0.005
Press ACT. The SET RISE RATE LIMIT screen flashes the rate alert default setting: OFF.
Select the Rise Rate Limit. The range and increments are the same as the Fall Rate Limit (see step 3
above).
Press ACT. The Rate of Change alerts will now use the settings you specified. You are now ready to set
up the Cal Repeat.
Sensor features
Setting the Cal Repeat
After you receive and clear a METER BG NOW alert, the device will repeat the alert until you enter a new
meter blood glucose measurement. The Cal Repeat feature allows you to set how frequently you want the
alert to repeat after you clear it.
1
2
3
4
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Edit Settings
Select Cal Repeat, then press ACT. The SET CAL REPEAT screen flashes the default Cal Repeat time of
30 minutes (0:30).
Set your Cal Repeat time between 5 minutes (0:05) and 1 hour (1:00).
Press ACT. The EDIT SETTINGS screen shows the Cal Repeat time you selected. You are now ready to set
your Cal Reminder.
Setting the Cal Reminder
The Cal Reminder feature allows you to set a reminder to calibrate your system. For example, if you set your
reminder to four hours, then you will receive a METER BG BY alert (Cal Reminder) four hours before the next
meter blood glucose (BG) entry is due (eight hours after your last successful sensor calibration).
To set up the Cal Reminder:
1
Make sure the EDIT SETTINGS screen is open.
2
3
4
5
Main > Sensor > Edit Settings
Select Cal Reminder, then press ACT. The CAL REMINDER screen shows On.
Press ACT. The SET CAL REMINDER screen flashes the Cal Reminder default time of 1 hour (1:00).
Select your Cal Reminder time between 5 minutes (0:05) and 6 hours (6:00).
Press ACT. The EDIT SETTINGS screen shows the Cal Reminder time you selected. You are now ready to
enter your transmitter ID number.
Entering the transmitter ID
The transmitter ID (serial number) starts with 2 and is found on the flat side of your transmitter. You must
enter the transmitter ID so that the transmitter and the pump can communicate with each other.
Chapter 7
Sensor features
111
Write the Transmitter ID of the transmitter you are using here: __________________.
1
Make sure the EDIT SETTINGS screen is open.
2
Main > Sensor > Edit Settings
Select Transmtr ID, then press ACT. The SET TRANSMITTER ID screen appears. The screen shows seven
dashes for the Transmitter ID, the first of which (on the left) is flashing.
3
Select the first number of the Transmitter ID (the number on the screen must
match the first number of the Transmitter ID). The transmitter ID is located on
the transmitter label, as shown.
SN GT2XXXXXXM
MEDTRONIC MINIMED
MiniLink Transmitter
REF MMT-7703XX
SN GT2XXXXXXM
FCC D: OH27703
IC: 3458-7703
IPX8
1234
4
5
6
7
Press ACT. The second dash flashes.
Select the next number of the Transmitter ID, then press ACT.
Repeat step 5 until all seven digits of the Transmitter ID have been selected.
A message shows that the Transmitter ID has been changed. After about 30 seconds, the EDIT SETTINGS
screen appears. It shows the Transmitter ID you entered.
You are now ready to set up the Weak Signal.
Setting up the Weak Signal feature
The Weak Signal feature allows you to determine how quickly you will receive a Weak Signal alert when there
is no communication between the transmitter and the pump. For example, if you set the Weak Signal value
to 30 minutes, you will receive a Weak Signal alert 30 minutes after loss of communication.
To set up the Weak Signal feature:
1
2
3
4
5
112
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Edit Settings
Select Weak Signal, then press ACT. The SET WEAK SIGNAL screen flashes the default time of 30 minutes
(0:30).
Select your Weak Signal time between 5 minutes (0:05) and 40 minutes (0:40).
Press ACT. The EDIT SETTINGS screen shows the length of time you entered for the Weak Signal option.
You are now ready to set up the sensor glucose graph timeout.
Sensor features
Setting the sensor glucose graph timeout
The sensor glucose graph timeout is how long the graphs show on the pump screen until the HOME screen
automatically appears. The default timeout is two (2) minutes, and you can set it for 2, 4, or 6 minutes.
Using a continuous graph display
You can also select NONE to set the sensor graph timeout to display continuously. If you select NONE, the
sensor graphs will show until another screen or menu is selected, or an alarm/alert occurs. Selecting
continuous graph display uses more battery power and decreases battery life. To return to the HOME screen
from the sensor glucose graphs, press ESC until the HOME screen appears.
To set the sensor glucose graph timeout:
1
2
3
4
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Edit Settings
Select Graph Timeout, then press ACT. The SET GRAPH TIMEOUT screen flashes the default time of
2 minutes (0:02).
Select your Graph Timeout. The time you select must be: 2 minutes; 4 minutes; 6 minutes; or NONE.
Press ACT. The EDIT SETTINGS screen shows the Graph Timeout you selected.
You are now ready to review your sensor glucose monitoring settings.
Reviewing your settings
Make sure that all the settings you have made are correct before you use the system. Use the following
procedure to review your settings:
1
Open the REVIEW SETTINGS screen.
2
Main > Sensor > Review Settings
to scroll through all settings to make sure that they are correct.
Press
3
To change any settings, return to the EDIT SETTINGS menu.
4
Main > Sensor > Edit Settings
Save your settings after you have set your preferences. This will allow you to restore the settings you
have saved if you receive an alarm or error that resets your settings.
Chapter 7
Sensor features
113
Using the Sensor Demo
The Sensor Demo shows you a demonstration of a sensor graph. To view the Sensor Demo screen, you must
first turn on the Sensor Demo feature. After the Sensor Demo feature is turned on, the first line of the STATUS
and SENSOR STATUS screens will show SENSOR DEMO: On.
Turning on the Sensor Demo feature
1
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Edit Settings
2
3
The EDIT SETTINGS screen shows Sensor Demo: Off.
Press ACT. The SENSOR DEMO ON/OFF screen appears with Off selected.
Select On, then press ACT. The EDIT SETTINGS screen shows that SENSOR DEMO is now turned On.
CAUTION: The Sensor Demo feature affects the sensor demonstration graph only. All other features,
screens and options are in the normal mode.
Viewing the Sensor Demo screens
1
2
3
From the HOME screen, press ESC. The screen briefly shows SENSOR DEMO, then the first Sensor Demo
graph appears.
You can move the cursor (flashing vertical line) through the graph to see examples of how the real-time
to move the cursor left, press
to move the cursor right.
graphs appear. Press
You must turn the Sensor Demo off in order to show your actual, real-time sensor glucose graphs. To
turn the Sensor Demo off, follow the above procedure and select Off.
The transmitter
The Medtronic MiniLink Transmitter (MMT-7703) is a device that takes electronic signals generated by the
glucose sensor and sends them by radio frequency to the pump. It has a tester (MMT-7706) and a charger
(MMT-7705 or MMT-7715). For details on how to use your transmitter, charger and tester, see your transmitter
user guide.
Starting the sensor
To start the sensor working, you must complete the following steps in order:
•
•
114
Insert a battery into the transmitter's charger.
Charge the transmitter battery.
Sensor features
•
•
•
•
•
Set up the sensor features.
Insert the sensor and wait 10-15 minutes.
Connect the transmitter to the sensor.
Start the sensor and wait two hours.
Enter your first meter BG.
Inserting the sensor
Before inserting the sensor, you must fully charge and set up the transmitter. Also, if the sensor has been
refrigerated, remove the sensor package from refrigeration. To avoid condensation, make sure that you allow
the sensor package to reach room temperature before opening.
The sensor is inserted through the skin with an insertion device, and placed in the fatty layer under the skin.
The sensor produces a signal that reflects the amount of glucose in the interstitial fluid at the insertion site.
This signal is sent to the transmitter, which is then sent to the pump. The pump translates the signal and
displays a sensor glucose reading on your pump screen.
WARNING: The sensor may create special needs regarding your medical conditions or medications. Please
discuss these conditions and medications with your doctor before using the sensor.
Bleeding, swelling, irritation and/or infections at the insertion site are possible risks associated with
inserting the sensor and may result from improper insertion and maintenance of insertion site.
Choose a site with an adequate fatty layer for sensor insertion. Be sure to rotate
the sensor sites so that they do not become overused. Shown here are the best
body areas (shaded) for sensor insertion. The clinical trials of sensor accuracy
have been based on sensors inserted in the abdominal area. Sensor performance
may differ when other insertion sites are used.
CAUTION: Never insert the sensor within 2 inches (5.0 cm) from the pump
infusion set insertion site or within 3 inches (7.5 cm) from the manual
injection site.
Areas to avoid:
Chapter 7
•
•
•
Frequently used injection or pump/sensor sites
2 inch (5.0 cm) area around navel
Site where clothing will rub or constrict
Sensor features
115
•
•
Scarred or hardened tissue
Areas subjected to a lot of movement
Clean site with alcohol, making sure site is dry before inserting the sensor. Do not use skin-preparation
solutions prior to insertion. However, I.V. Prep may be used after insertion and before applying a sterile
dressing. Lift back of tape slightly to apply I.V. Prep.
Always refer to the instructions that shipped with your glucose sensor.
1 Wash your hands.
2 Clean the sensor site with alcohol. Let it air dry.
3 Remove the sensor from the package by holding the base or tape. Do not hold the sensor by the introducer
needle handle.
4 Place the sensor in the Sen-serter until it fits snugly.
5 Place your fingers on the white tape and push the carrier down until it clicks into place.
6 Holding the white tape as shown, remove the clear tape.
4
5
6
7 Remove the needle guard from the introducer needle.
8 Rest the Sen-serter legs flat on your skin so the Sen-serter is at an angle that is 45 to 60 degrees to the
insertion site. Bleeding can occur if you insert the sensor at an angle less than 45 degrees. Place two
fingers of your other hand on the Sen-serter legs to maintain the correct angle.
116
Sensor features
9 Press the white button to insert the sensor.
7
8
9
10 Make sure the sensor is inserted. If the sensor is not fully inserted, manually push it into place. The
sensor should lay flat on your skin.
11 While holding the sensor in place, gently slide the Sen-serter away from the sensor. Do not twist, bend
or lift the Sen-serter while removing it from the sensor.
12 While still holding the sensor in place, remove the white paper from the adhesive pad. Press the adhesive
against your skin.
13 Hold the sensor with two fingers on the base, and gently remove the introducer needle. Do NOT rotate
the introducer needle when removing. Dispose of the needle in sharps container.
11
12
13
Sensor features
Chapter 7
14 Wait 10–15 minutes after insertion before connecting the transmitter to the sensor to make sure the
sensor is ready to communicate. Make sure that the site is not bleeding before connection. If bleeding
occurs, apply pressure using a sterile gauze or clean cloth for three minutes.
117
a. When bleeding stops, attach the transmitter to the sensor.
CAUTION: If bleeding does NOT stop, do NOT connect the transmitter to the sensor.
b. If bleeding does not stop, do the following:
i Remove the sensor and discard.
ii Reapply pressure using a sterile gauze or a clean cloth until the bleeding stops.
iii Insert a new sensor in a different location.
Removing the sensor
When you are ready to change your sensor, disconnect it from the transmitter as described in your transmitter
user guide. Gently pull the sensor from your body to remove it. Place it in a sharps container.
Preparing the sensor for communication
Connect your transmitter to your sensor as described in the transmitter user guide. When the green light on
the transmitter flashes, use your pump to follow the steps below.
1
2
3
4
5
Go to the LINK SENSOR MENU screen.
Main > Sensor > Link to Sensor
Select New Sensor. Press ACT.
Connect the transmitter to your sensor now if you have not already done so. If the screen times out, do
not disconnect the sensor. Start from step 1 again.
After your sensor is connected, press ACT. The SENSOR READY 2 HRS screen appears.
The sensor will enter a two hour initialization period. Press any button to continue. After 2 hours your
pump will alert you to enter a meter BG to calibrate your sensor.
Calibrating the sensor
Two hours after you use your pump to start the sensor, your pump will alert you to enter a meter BG (METER
BG NOW). This meter BG entry will be the first calibration for your sensor. You have to wait 10–15 minutes
after calibration to see the first sensor glucose reading on the pump screen. Six hours after the first
calibration, the pump will alert you to enter the second calibration.
118
Sensor features
After the second calibration, you must calibrate your sensor every 12 hours. If you fail to enter a meter BG
reading after 12 hours, your pump displays the METER BG NOW alert. Your pump will then stop calculating
glucose values. However, about 20 minutes after you have entered a meter BG, your pump will continue
calculating glucose values.
Follow these guidelines for best calibration results:
•
•
•
•
•
Calibrate three to four times spread out throughout the day.
Avoid calibrating when your glucose is changing rapidly, such as after eating or exercise.
Enter your meter BG reading into the pump immediately after testing your BG. Do not wait to enter it
later.
Always use clean dry fingers when you check your blood glucose.
Only use your fingertips to obtain blood samples for calibration.
After the transmitter successfully transmits signals to the pump, you may choose to put an occlusive dressing
over the transmitter and the sensor.
Entering meter BG for calibration
Sensor calibration is necessary for optimal glucose sensor performance. Only BG entries in the range of 40–
400 mg/dL (2.2–22 mmol/L) are accepted for sensor calibration.
Use any of the following methods for your sensor calibrations, including the first calibration after the
initialization. You can enter BG values manually or through your linked meter.
To enter BG values manually:
1
You can enter a meter BG value manually in the Bolus Wizard.
a. Press the
button on your pump, or use the MAIN MENU to go to the ENTER BG screen:
Main > Bolus > Use Bolus Wizard
2
b. Use the up and down arrow buttons on your pump to enter your meter BG. Press ACT.
c. Select Yes to calibrate, or No to cancel, when the following screen displays: BG to update Sensor?
You can enter a meter BG value manually through the Sensor menu.
a. Follow this path:
Chapter 7
Main > Sensor > Calibrate
Sensor features
119
3
b. Enter the BG value, and then press ACT. Your sensor is now calibrated with the BG value you entered.
•
If the Bolus Wizard feature is off, the SENSOR MENU screen appears.
•
If the Bolus Wizard is on and the saved BG is below your BG Target range, the Cal 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 69 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 Cal 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 Using the Bolus Wizard feature chapter for more information.
•
If the information is not correct, select Cancel, then press ACT. The SENSOR MENU screen
reappears with Calibrate selected. Repeat the procedure and enter the correct information.
You can enter a meter BG value manually through the Capture Event menu. Follow this path:
Main > Capture Event > Enter BG
See page 36 for more information.
To enter BG values through your linked meter:
1
2
120
Test your BG with a fingerstick.
The BG value is automatically sent from the meter to your pump. This value displays in the following
screen: BG to update Sensor. Select Yes if you want to calibrate your sensor. Select No if you do not
want to use your BG value for calibration.
Make sure that your pump and the meter are properly programmed for communication. See Meter option,
on page 72 for more information.
Sensor features
Using your sensor
Your STATUS screens tell you what is going on in your pump. In the SENSOR STATUS screen you can check the
status of sensor information including when your next calibration will be needed, your sensor's age, and the
state of your transmitter battery.
Chapter 8
Status screens
To get to your status screens:
1
From the HOME screen, press the ESC button twice. This takes you
to your pump status screen.
2
To see the Sensor Status screen, press ESC one more time. This
screen will only be available if the Sensor feature has been turned
On.
Using your sensor
121
Reading the sensor glucose graphs
NOTE: If your graphs say DEMO in the upper left corner of your screen, you must turn off the SENSOR
DEMO mode to see your actual graphs (see the Using the Sensor Demo section in the Sensor features chapter).
Your pump shows an updated, real-time glucose measurement. This measurement is generated by data sent
from the sensor to the transmitter, and then to the pump every five minutes. The pump converts these
measurements to glucose graphs that include the following information:
•
•
•
The most recent sensor glucose measurement or the reason that one is not displayed.
The historical sensor glucose measurements or the reason that one is not displayed for the last 3,
6, 12 or 24 hours.
Arrows that show the relative rate at which the most recent sensor glucose levels have risen or
fallen.
The following conditions can prevent a real-time sensor glucose measurement from being taken:
•
•
•
•
•
•
•
•
A Lost Sensor alert.
A Sensor Error alert.
A Change Sensor alert.
A Cal Error alert.
Find Lost Sensor (15 minutes).
Weak signal.
Reconnect old sensor (two hours).
A meter BG entry is needed for calibration.
Two other conditions also prevent a real-time SG measurement and generate a WARM UP message on your
sensor glucose graphs:
•
•
122
You started a new sensor, and it has entered a two-hour initialization. The sensor is not ready to take
glucose measurements.
You entered a BG for calibration, and your pump is waiting to receive the first valid SG value.
Using your sensor
Opening and viewing the graphs
The following table describes how to use the graphs.
Do the following:
If you want to:
From the HOME screen, press ESC. The last graph you viewed (3-, 6-, 12or 24-hour) shows the details for your most recent sensor glucose (SG)
measurement.
View information in a graph
If there is no SG measurement at the time you select, the reason for the
missing measurement will be shown on the right side of the graph (for
example, LOST SENSOR).
•
When you open the graphs, the cursor (flashing vertical line) is always
on the right edge of the graph and the graph shows the most recent
SG measurement.
to move the cursor left to see an earlier SG measurement.
•
Press
•
Press
Chapter 8
Open the graphs
to move the cursor right to return to more recent SG
measurements.
View different graphs
•
With the cursor at the far right edge of a graph, you can press
to
•
open the next graph.
If the cursor is anywhere to the left of the far right edge, press ESC
to move it to the right, then press
to open the next graph.
Using your sensor
123
The graphs
All graphs show High and Low Glucose Limits lines, a real-time SG measurement line, a data section, and the
cursor (flashing vertical line).
When you open any graph, the cursor flashes on the right edge of the graph. There are three marks on the
cursor at 100, 200, and 300 mg/dL (or 5, 10, and 15 if mmol/L is selected). The data section shows the most
recent SG measurement or the reason why no measurement shows, and the time in the data section matches
the time at the top of the screen.
Sensor glucose data
points.
High Glucose
Limit Line at
191 mg/dL
(10.6 mmol/L)
Low Glucose
Limit Line at
58 mg/dL (3.2
mmol/L)
Indicates that your glucose has risen
above 315 mg/dL (17.5 mmol/L).
3:16P
3 Hour
281
Each time you
bolus, a marker will
appear on your
graph.
Data section shows
the selected time,
the type of graphs
(or “History” if you
have scrolled to the
left on the graphs),
and the sensor
glucose
measurement (or
alert).
Cursor (flashing line) indicates selected time,
and the sensor glucose measurement (or
alert) for that time. There are three marks on
the cursor at 100, 200, and 300 mg/dL (or 5,
10, and 15 if mmol/L is selected).
When you move the cursor left to select an earlier SG measurement, the data section of the graph turns
black, the word History appears here, and the time in the data section changes to show the time when the
SG measurement was taken or the reason why no SG measurement shows for that time.
124
Using your sensor
NOTE:
There are many reasons your graphs may not show an SG
measurement, but your system does not alert for every one.
Therefore, your system’s alarm/alert history may not match the
number of times your graphs do not show an SG measurement.
2:20P
History
LOST
SENSOR
Chapter 8
Examples of real-time sensor glucose graphs
The following pages show examples of the different graph types.
3-hour graph
Each part of the graph between the vertical dashed lines represents one hour. In this example, the selected
SG measurement was taken at 3:16 PM, and the value at that time was 281 mg/dL (15.6 mmol/L).
3:16P
3 Hour
281
1:00 PM
2:00 PM
3:00 PM
3 hours
Using your sensor
125
6-hour graph
Each part of the graph between the vertical dashed lines represents one hour. In this example, the selected
SG measurement was taken at 1:12 AM, and the value at that time was 150 mg/dL (8.3 mmol/L).
1:12A
History
150
11:00 PM
2:00 AM
6 hours
12-hour graph
Each part of the graph between the vertical dashed lines represents one hour. In this example, the reason
no measurement is displayed is LOST SENSOR and it occurred at 2:20 PM.
2:20P
History
LOST
SENSOR
6:00 AM
10:00 AM
12 hours
126
Using your sensor
2:00 PM
24-hour graph
Each part of the graph between the vertical dashed lines represents 12 hours. The shaded area helps you
more easily see the sensor glucose measurements for the previous night. In this example, the selected SG
measurement was taken at 11:50 AM and the value at that time was 211 mg/dL (11.7 mmol/L).
Chapter 8
The shaded area is the 12
hours from 6:00 PM to 6:00 AM
11:50A
24 Hour
211
24 hours
Using your sensor
127
How to check for rapid changes in sensor glucose
If your sensor glucose (SG) rises or falls faster than a certain rate, rapid change arrows automatically appear
in the graphs next to the SG measurement, as shown in the following section.
The rapid change arrows
These examples show how the rapid change arrows tell you when your SG rises or falls faster than a certain
per-minute rate. The arrow direction shows if your SG measurements are rising or falling. The number of
arrows (one or two) shows how rapidly your SG is changing.
•
One up arrow
shows that your SG has been rising at a rate of
1 to 2 mg/dL (0.05 to 0.11 mmol/L) per minute.
3:16P
3 Hour
240
•
One down arrow
shows that your SG has been falling at a rate
of 1 to 2 mg/dL (0.05 to 0.11 mmol/L) per minute.
3:11P
3 Hour
131
•
Two up arrows
show that your SG has been rising at a rate
of 2.0 mg/dL (0.11 mmol/L) or more per minute.
3:11P
3 Hour
212
•
Two down arrows
show that your SG has been falling at a
rate of 2.0 mg/dL (0.11 mmol/L) or more per minute.
3:11P
3 Hour
103
128
Using your sensor
How to make glucose alerts silent
When one or more glucose alerts occur during the time when the Alert Silence feature is turned on, the pump
displays the ALERT SILENCE screen without beeping or vibrating. If this alert is not cleared before the end
of the silenced period, the pump beeps or vibrates periodically at the end of the preset time until the alert
is cleared. Press ESC, then ACT to clear the alert.
Chapter 8
The Alert Silence feature allows you to silence glucose alerts for a preset amount of time. You may use this
feature when you are in a business meeting, watching a movie in a theater, and so on. The system records
the time and glucose measurement for each alert during this silent period. You can see this alert information
in the SENSOR ALERT HISTORY screen. See the Sensor alert history section in this chapter for details.
You can make the glucose alerts silent in the following ways:
•
•
•
•
•
Off — This means the Alert Silence feature is Off and the alerts are On. The pump beeps or vibrates
when any sensor glucose alert occurs.
Hi Alerts — The pump does not beep or vibrate if a high or rising sensor related alert occurs during the
specified time.
Lo Alerts — The pump does not beep or vibrate if a low or falling sensor related alert occurs during the
specified time.
Hi and Lo Alerts — The pump does not beep or vibrate if a high or low, rising or falling sensor related
alert occurs during the specified time.
All Sensor Alerts — The pump does not beep or vibrate if any sensor glucose alert occurs during the
specified time, including the Hi and Lo glucose alerts, Cal Reminder, and Meter BG Now alerts.
The amount of time that you can make glucose alerts silent is:
•
•
Minimum: 30 minutes
Maximum: 24 hours
To make alerts silent:
1
2
3
Open the SENSOR MENU.
Main Menu > Sensor
The SENSOR MENU shows you the current status of the Alert Silence feature.
Depending on your current settings, one of the following Alert Silence options will appear in the SENSOR
MENU.
•
Alert Silence: Off
•
Alert Silence: Hi
•
Alert Silence: Lo
Using your sensor
129
4
5
6
7
•
Alert Silence: Hi/Lo
•
Alert Silence: All
To change the current alert silence settings, select Alert Silence, then press ACT.
Select the alert silence option you want, then press ACT. The SET DURATION screen flashes a set of
dashes or the length of time that you entered the last time you set an alert to silent.
Select your alert silence length between 30 minutes (minimum) and 24 hours (maximum), then press
ACT. The pump is in Special mode for the set silenced period.
The SENSOR MENU shows the new alert that you selected to be silent.
Press the ESC button until the MAIN MENU appears.
Calibration history
The CALIBRATE HISTORY screen lists the successful sensor calibration BG values that were entered into the
pump more than 15 minutes ago.
To view your Calibration History:
1
Go to the CALIBRATE HISTORY screen.
2
Main > Sensor > Calibration Hist.
The CALIBRATE HISTORY screen appears. It shows up to 28 calibration values.
Sensor alert history
The SENSOR ALERT HISTORY screen lists all of the sensor alerts that have occurred, displaying up to 36 alerts.
To view your Sensor Alert History:
1
2
3
130
Go to the SENSOR ALERT HISTORY screen.
Main > Sensor > Sensor Alert History
The SENSOR ALERT HISTORY screen appears. The most recent alert is highlighted. Select the alert you
want to get more information on, then press ACT.
A new screen will appear with the alert details.
Using your sensor
Using your system in water
Your pump must not be used in water and needs to be removed if planning water activities.
You should shower, bathe and swim with the transmitter and the sensor by following the guidelines
below:
3
4
Disconnect the infusion set from the pump and remove the pump. The pump is not water-tight.
After the transmitter and sensor are connected, they form a water-tight seal to a depth of 8 feet
(2.4 meters) for up to 30 minutes. You can shower and swim without removing them. Avoid taking hot
baths as this may significantly reduce the sensor's life.
Once out of the water, put the pump back on and reconnect the infusion set.
Check your infusion set tape and the sensor tape to make sure that they are not damaged.
Using your sensor
Chapter 8
1
2
131
132
Using your sensor
Utilities
Alarm review
1
2
3
4
Go to the ALARM HISTORY screen.
Main > Utilities > Alarm > Alarm History
Scroll through your past alarms.
In the ALARM HISTORY screen, select the alarm you want to review and press ACT. The details for that
alarm will appear on the screen.
Press ESC to return to the ALARM HISTORY screen. Select another alarm to review, or exit the menus if
you are done.
Chapter 9
You can review alarms and their details in the ALARM HISTORY screen. This screen shows up to 36 past alarms,
errors, or LOW RESERVOIR and LOW BATTERY alerts.
Setting your alert type
You can select the type of alert your pump uses (for alarms, special conditions and programming). You can
select a vibrate (silent) alert, or an audible beep alert. There are three beep types: long, medium and short
tones. The factory setting for this feature is beep-medium.
The vibrate alert type is disabled if you use the block feature, and vibrate must be set again once block is
turned off. Vibrate uses more battery power than the beep alert type and may shorten battery life. If your
alert type is set to vibrate and you get a LOW BATTERY alert, your pump will use the beep alert type instead
to conserve battery power.
1
Go to the ALERT TYPE screen.
2
Main > Utilities > Alarm > Alert Type
Select your alert type and press ACT. That alert type is now active. Exit the menus.
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133
Auto-off
The factory setting for this feature is Off. This is a safety feature that stops insulin delivery after a defined
time period (from 1 to 24 hours). If the pump detects that no buttons have been pressed for the selected
amount of time in Auto-off, insulin delivery will stop and an alarm will sound. You may choose to program
this feature into your pump based on the number of hours that you usually sleep at night. Discuss what uses
and settings are best for you with your healthcare professional.
1
2
3
Go to the AUTO OFF DURATION screen.
Main > Utilities > Alarm > Auto Off
Set the number of hours you want to set and press ACT.
If you do not want to use the Auto Off feature, make sure the hour is set to zero (0).
The screen will return to the ALARM MENU. The Auto Off feature is now set. Exit the menus.
LOW RESV WARNING (Low reservoir warning)
Allows you to program the pump to sound an alert before your reservoir is empty. You can select one of these
warning types:
•
•
a specified number of units that remain in the reservoir
a specified maximum amount of time that remains before the reservoir will be empty
The factory setting for this feature is 20 insulin units.
If you use Time as the low reservoir warning type and you deliver large boluses, the actual time remaining
could be less than the warning time. The warning time is based on the basal insulin delivery rate. The Time
low reservoir warning type is intended to let you know if you will have enough insulin while you are sleeping.
1
Go to the RESV WARNING TYPE screen.
2
Main > Utilities > Alarm > Low Resv Warning
Select Insulin Units or Time and press ACT.
WARNING: When the pump detects a low reservoir condition during a bolus or Fill Cannula delivery,
the LOW RESERVOIR alert displays after the delivery is finished. Make sure to check the volume of
your reservoir to ensure enough insulin is available.
a. For Insulin units:
In the WARNING UNITS screen enter the number of units you want remaining for the first warning,
then press ACT.
134
Utilities
The pump displays a LOW RESERVOIR alert first when the specified units remain, then again when
half that remaining amount is used.
b. For Time:
In the WARNING TIME screen enter the amount of remaining time you want the first warning, then
press ACT.
The pump displays a LOW RESERVOIR alert first when the specified time remains, then again one
hour before empty.
Review daily insulin totals
Chapter 9
The DAILY TOTALS screen provides a day-by-day history of the total amount of insulin that delivered for the
last 32 days, including today. This screen includes all bolus and basal amounts delivered midnight-to-midnight
for each of the last 32 days. The Today line in the DAILY TOTALS screen shows the amount of insulin you
delivered so far that day.
The insulin used to fill the tubing or the cannula is not included in the DAILY TOTALS screen. This amount is
counted separately and shown in the HISTORY screen of the RESERVOIR + SET MENU.
Question: Why should I review my daily totals?
Answer: Comparing your daily insulin deliveries to your blood glucose records helps you and your healthcare
professional identify your optimal daily insulin rate(s).
Question: What is included in the daily totals?
Answer: Daily totals include all basal and bolus insulin deliveries, sensor glucose, meter blood glucose, and
AUC information for that day.
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135
Pump data management
The pump data management feature allows you and your healthcare professional to view and manage your
basal and bolus insulin delivery, food intake, BG data, SG data, and AUC data with averages. You can view
the details of each day individually or you can average the data over a specified number of days (up to 32
days).
•
•
Daily totals — The system automatically tracks certain types of information for you on a day-to-day basis.
The daily totals are the totals for a single day.
Averages — The system automatically calculates averages of certain types of information for you. There
are two basic types of averages:
•
An average over a number of days (you select the number of days)
•
An average for a single day
The insulin delivery, food intake, sensor glucose information, meter blood glucose information, and AUC data
includes daily totals and averages, as described in the following sections.
Insulin delivery information
This table lists the different types of insulin delivery and food intake information that the system
automatically records. This information is calculated by using all of the basal, bolus, and food data for that
day.
An asterisk (*) next to a date means that the data for that day will not be used for the calculations that are
displayed in the Daily Average option. Anything, such as a time or date change, that shortens a day at least
one hour and twelve minutes (01:12) will cause the asterisk to be displayed.
Item
136
Description
Carbs
The total number of carbohydrates entered using the Bolus Wizard and
Capture Event (Meal marker) features.
Tot Insulin
The total amount of insulin delivered with the pump.
Basal (first line)
The total amount of insulin delivered as basal.
Basal (second line)
The percent of insulin delivered as basal.
Bolus (first line)
The total amount of insulin delivered as bolus.
Bolus (second line)
The percent of insulin delivered as bolus.
Food Only
The total amount of insulin delivered using the Bolus Wizard feature with
food amount only.
Utilities
Item
Description
The number of times the Bolus Wizard feature delivered a food bolus only.
Corr Only
The total amount of insulin delivered using the Bolus Wizard feature with
BG correction amount only.
#Corr Only
The number of times the Bolus Wizard feature delivered a BG correction
bolus only.
Food+Corr
The total amount of insulin delivered using the Bolus Wizard feature with
food and BG correction amount.
#Food+Corr
The number of times the Bolus Wizard feature delivered a food and BG
correction bolus.
Manual
The total amount of insulin delivered manually.
#Manual
The number of manual insulin deliveries.
Chapter 9
#Food Only
Sensor glucose information
This table lists the different types of sensor glucose information that the system automatically records. The
sensor glucose information is calculated by using all of the sensor glucose measurements that were received
by the pump during the day.
Item
Description
SG Average
The average sensor glucose measurement.
Above Hi Limit
The percentage of sensor glucose measurements that were above your High
Glucose Limit.
Within Limits
The percentage of sensor glucose measurements that were between your
Low Glucose Limit and your High Glucose Limit.
Below Low Limit
The percentage of sensor glucose measurements that were below your Low
Glucose Limit.
SG Std. Dev.
The standard deviation of the sensor glucose measurements.
#Hi Alert
The number of High Glucose alerts.
#Lo Alert
The number of Low Glucose alerts.
#Predict Hi
The number of High Predictive Glucose alerts.
#Predict Lo
The number of Low Predictive Glucose alerts.
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137
Item
Description
#Rise Rate
The number of Rise Rate alerts.
#Fall Rate
The number of Fall Rate alerts.
Number SGs
The number of SG measurements received from the transmitter.
Meter blood glucose information
The table below lists the different types of meter blood glucose information that the system automatically
records. The meter blood glucose information is calculated by using all of the automatic and manual meter
blood glucose measurements that were received by the pump for the day, or number of days. This includes
measurements that were manually entered into the pump during that time.
Description
Item
BG Average
The average meter blood glucose measurement.
Number BGs
The total number of meter blood glucose measurements taken.
Meter L/H
The lowest and highest blood glucose measurements sent by the meter (L
is the lowest, and H is the highest). These can be used for calibration or
non-calibration purposes.
Manual L/H
The lowest and highest manually entered blood glucose measurements (L
is the lowest, and H is the highest). These can be used for calibration or
non-calibration purposes.
To view data for a single day:
1
2
3
4
Go to the DAILY TOTALS screen.
Main > Utilities > Daily Totals
Select the day that you want to view.
• To view totals for today, select Today.
•
To view totals for a previous day, select the date.
Press ACT. The DELIVERY STATS screen shows the basal, bolus, and food intake information for the day
you selected in step 2. This day is shown on the title line of the screen.
Press
to view more information. See the table in the Insulin delivery information section in this
chapter for descriptions of information shown here.
138
Utilities
5
6
7
9
chapter for descriptions of the sensor glucose information.
To view meter blood glucose measurement information for the same day you have selected in step 2,
press ACT from the SENSOR STATS screen. The METER STATS screen appears, showing the meter blood
glucose information for the day you selected. The day you selected is shown on the title line of the
screen.
Press
to view all of the information in the METER STATS screen. See the table in this section for
descriptions of the meter blood glucose information shown here.
Press ACT to toggle between the different STATS screens. Press ESC from any STATS screen to go to the
DAILY TOTALS screen.
Continue viewing daily totals by following the steps above, or press ESC until the HOME screen appears.
Chapter 9
8
To view sensor glucose information for the same day you have selected in step 2, press ACT from the
DELIVERY STATS screen. The SENSOR STATS screen appears, showing the sensor glucose information for
the day you selected. The day you selected is shown on the title line of the screen.
to view more information. See the table in the Sensor glucose information section in this
Press
The following procedure shows you how to view insulin delivery, food intake, sensor glucose and meter blood
glucose data for a selected number of days.
To view data over a number of days:
1
Go to the DAILY TOTALS screen.
Main > Utilities > Daily Totals
2
3
4
5
6
7
The DAILY TOTALS screen shows Daily Average selected.
Press ACT. The DAYS TO AVERAGE screen flashes the number of days you selected the last time you used
this feature.
Select the number of days that you want to average. For example, if you want to see the averages for
the last seven days, select 7.
Press ACT. A message tells you that the pump is calculating the averages.
The DELIVERY STATS screen shows the insulin delivery and food intake information for the number of
days you selected. The number of days is shown on the title line of the screen.
Press
to view more information. See the table in the Insulin delivery information section in this
chapter for descriptions of the information shown here.
To view sensor glucose information for the same days you selected in step 3, press ACT. The SENSOR
STATS screen appears, showing the sensor glucose information.
Press
to view more information. See the table in the Sensor glucose information section in this
chapter for descriptions of the information shown here.
Utilities
139
8
9
To view meter blood glucose measurement information for the same days you selected in step 3, press
ACT. The METER STATS screen shows the meter blood glucose information.
Press
to view more information. See the table in the Meter blood glucose information section in this
chapter for descriptions of the information shown here.
AUC calculation
The AUC (Area Under the Curve) feature measures how much and how long your sensor glucose measurements
are outside the pre-defined AUC Limits. Check with your healthcare professional to determine the AUC
settings that are best for you. The AUC Limits are different than the Glucose Limits. The AUC Limits are used
to analyze the sensor glucose measurement data that is stored in your system. The closer the AUC values are
to zero, the closer your SG values are to your AUC Limits. If your AUC values are zero, then your SG values
are within your AUC Limits.
The default AUC Limits are:
•
•
Low AUC Limit: 70 mg/dL (3.9 mmol/L)
High AUC Limit: 180 mg/dL (10.0 mmol/L)
To set the AUC Limits:
1
2
3
4
5
140
Go to the AUC MENU.
Main > Utilities > Daily Totals > Calculate AUC
Select AUC Limit, then press ACT. The SET AUC LIMITS screen appears. The default LOW AUC Limit flashes
70 mg/dL (3.9 mmol/L).
Select your Low AUC Limit. The number must be between 40 and 400 mg/dL (2.2 and 22.2 mmol/L).
Press ACT. The default High AUC Limit flashes 180 mg/dL (10.0 mmol/L).
Select your High AUC Limit. The number must be between 40 and 400 mg/dL (2.2 and 22.2 mmol/L). It
can be equal to, but not lower than, the AUC Low Limit.
Utilities
6
Press ACT. The AUC MENU screen shows the AUC Limit you selected.
To view AUC data for a single day:
1
2
3
Go to the AUC MENU.
To view AUC data over a number of days:
1
2
3
4
5
Chapter 9
Main > Utilities > Daily Totals > Calculate AUC
Select the day that you want to view.
• To view totals for today, select Today.
•
To view totals for a previous day, select the date.
Press ACT. AUC High and AUC Low values appear for the selected day.
•
AUC High is the average of AUC for sensor glucose values above the AUC High Limit for that day.
•
AUC Low is the average of AUC for sensor glucose values below the AUC Low Limit for that day.
Go to the AUC MENU.
Main > Utilities > Daily Totals > Calculate AUC
Select AUC #Days, then press ACT.
The DAYS TO AVERAGE flashes the number of days to average. Select the number of days you want. For
example, if you want to see the averages for the last seven days, select 7.
Press ACT. A message tells you that the pump is calculating averages.
The Day Average screen shows the data for the number of days you selected. The number of days is
shown on the screen. For example, if you have selected seven days, the screen title will be 7Day
Average. AUC High and AUC Low appear below the title.
•
AUC High is the average value of AUC for sensor glucose values above the AUC High Limit for the
number of days selected.
•
AUC Low is the average value of AUC for sensor glucose values below the AUC Low Limit for the
number of days selected.
Utilities
141
Personal reminders
Alarm clock
The alarm clock is a feature that allows you to set a maximum of eight daily reminders for various events.
The factory setting for this feature is off. The alarm clock can be useful to remind you when to check your
blood glucose, eat, bolus, etc. When the alarm clock goes off, the ALARM CLOCK screen appears. Press
ESC, then ACT to clear the reminder.
1
Go to the ALARM OPTION screen.
2
3
4
5
6
Main > Utilities > Alarm Clock
Select On/Set. Press ACT.
Select Add Alarm. Press ACT.
Enter the hour (flashing). Press ACT.
Enter the minutes (flashing). Press ACT.
Repeat steps 3 through 5 to program additional alarm times. Exit the menus when you are done.
Remote control option
The factory setting for this feature is off. You may want to explore the remote option after you have become
completely familiar with the basic functions of your pump. It is important that you consult with your
healthcare professional before using this feature. Remote controls can be purchased from Medtronic
Diabetes.
Refer to the remote control user guide for operating instructions.
NOTE:
The use of RF (radio frequency) devices with the pump reduces battery life.
To use the remote control, these pump settings must be programmed:
•
•
•
142
Remote Options = On
Remote control ID code entered in pump (code is on back of remote)
Easy Bolus = On
Utilities
Turn on remote control option
WARNING: If there is a LOW BATTERY condition, the pump will not receive signals from the remote. To
ensure the pump communicates with the remote control, make sure the pump does not have a low
battery. (Replacing the low battery with a new battery will restore remote control function.)
Go to the REMOTE OPTION screen.
2
3
Main > Utilities > Connect Devices > Remotes
Select On, then press ACT.
The REMOTE ID MENU screen appears. Add, delete or review your remote ID as described in the next
section. Exit the menus if you are done.
Add, delete, review remote control IDs
Each remote control has its own unique ID. Up to three different remote control IDs can be programmed in
your pump. You must turn on the remote option to add, delete or review the remote control IDs programmed
in your pump.
1
2
3
4
Chapter 9
1
Adding a remote ID
a. Select Add ID from the REMOTE ID MENU screen, then press ACT.
b. Enter each of the six ID numbers found on the back of the remote control. Press ACT after each
entry. After you set the last number of the ID, the screen will return to the REMOTE ID MENU.
Deleting a remote ID
a. Select Delete ID from the REMOTE ID MENU screen, then press ACT.
b. Select the remote ID that you want to delete, then press ACT. The selected ID is now deleted.
Reviewing remote IDs
a. Select Review ID from the REMOTE ID MENU screen, then press ACT.
b. The programmed IDs will show in the REVIEW REMOTE ID screen.
Exit the menus when you are done.
Other Devices option
The factory setting for this feature is Off.
Other devices may be available to be linked to your pump. If available, refer to the appropriate device user
guide for programming and operating instructions.
Utilities
143
NOTE:
The use of RF (radio frequency) devices with the pump reduces battery life.
Block feature
Block restricts access to pump programming. The factory setting for this feature is off. Block is an important
safety feature if the pump user requires someone else to maintain complete control of pump operation. When
block is on, the remote control is used to deliver a bolus and suspend/resume the pump. Direct pump
programming is limited to suspend, block, and selftest. You can, however, still view status-type screens such
as STATUS, BOLUS HISTORY, BASAL REVIEW, and DAILY TOTALS. Discuss what uses and settings are best for
you with your healthcare professional. (You can order the remote control from Medtronic Diabetes.)
Turning block on
NOTE:
The vibrate alert-type is disabled when block is on.
1
Go to the BLOCK OPTION screen.
2
Main > Utilities > Block
Select On, then press ACT. The HOME screen will appear with an open circle. The Block option is now
on and the pump is in Special mode. Exit the menus.
Example 1: Block
Nicholas is a very active toddler who wears a Paradigm pump. His parents don't want to worry that he will
play with the pump and accidentally change his programmed settings. They simply activated the Block
feature, and now, except for the Suspend and Self-Test, no other features are active when using the pump
buttons. When Nicholas needs a bolus, his parents and caregivers simply program it with the Remote
Control.
Example 2: Block
Oscar is an elderly man with diabetes who needs assistance with all of his daily living activities. He needs
his caregiver or family member to help him with his pump as well. To be sure that Oscar does not change
any pump settings, his family programmed his Paradigm pump with the Block feature turned on. They use
the Remote Control to give him his boluses when he needs them.
144
Utilities
Lock keypad feature
Lock keypad prevents accidental pump keypad presses. You can only press the
and the
to view the STATUS screen,
button to turn on the backlight. The remote control can be used to give a bolus or put the pump
into Suspend.
A locked keypad is automatically unlocked during the following:
Battery insertion
Alarms
Alerts
Locking the keypad
1
2
3
Go to the UTILITIES MENU.
Select Lock Keypad, then press ACT.
Press ACT again to lock the keypad. The KEYPAD LOCKED screen appears with instructions on how to
unlock the keypad.
Chapter 9
•
•
•
Unlocking the keypad
Press the
button and the
button at the same time. Keypad Unlocked screen appears.
Selftest
Selftest is a safety utility that allows you to check if your pump is operating properly. This self-diagnostic
feature can be used for maintenance or to check your pump if it operates unusually. During selftest, your
pump will automatically run internal tests, including a check for proper operation of the beep and vibrate
modes. The selftest is additional to the routine tests that run independently while the pump operates.
Contact our 24 Hour HelpLine if any of the tests do not occur as described here.
NOTE:
If the pump detects a condition such as low battery, the selftest will not finish. A message will
appear to show the condition that caused the test to stop.
1
Go to the UTILITIES MENU.
2
Main > Utilities > Selftest
Select Selftest, then press ACT.
Utilities
145
3
4
Periodically, you will hear beeps as different mechanisms in the pump are being tested. As part of the
selftest, the pump will do these tests:
a. Screen Test:
The screen will appear all black.
b. Selftest:
The pump will count down from 10.
c. Tone Test:
You should hear beeps.
d. Vibrate Test:
You will feel vibrations.
After the selftest is finished, TEST COMPLETE screen appears. The screen will return to the UTILITIES
MENU, then to the HOME screen.
User settings
The user settings function allows you to save, restore, and clear all pump settings. You can also view a listing
of the dates and times of all recent user settings operations you have done. The Save Settings feature lets
you keep a set of pump settings that you can restore to your pump if it is cleared or you need to go back to
these settings for any reason.
When you clear your pump, the pump settings are restored to the factory defaults, and you must either use
Restore Settings, if you have saved a set of pump settings, or reprogram all your settings before you can use
your pump again. The pump does not clear the internal pump memory.
WARNING: Do not clear your pump settings while it is connected to your body.
CAUTION: Do not clear your pump settings unless directed by your healthcare professional or a Medtronic
Diabetes representative. If you clear your pump settings, it will be necessary to reprogram all your
personal pump settings as directed by your healthcare professional. Additionally, you will have to rewind
your pump.
146
Utilities
Saving the settings
Do these steps to save your current pump settings:
1
2
3
4
Main > Utilities > User Settings
Hold down
and press ACT.
The USER SETTINGS screen is displayed with Save Settings highlighted. Press ACT.
If this is the first time you have saved pump settings, go to step 5. If you have previously saved pump
settings, a message displays, indicating the date of your last pump settings save. Read the instructions
on the screen, then press ACT to save your current settings. You can press ESC if you want to cancel the
save.
The SETTINGS SAVED message displays to confirm that your current pump settings have been saved. Exit
the menus.
Chapter 9
5
Go to the UTILITIES MENU screen and select User Settings.
Restoring the settings
Do these steps to restore the most recent pump settings you have saved to your pump:
1
2
3
4
5
Go to the UTILITIES MENU screen and select User Settings.
Main > Utilities > User Settings
Hold down
and press ACT.
The USER SETTINGS screen is displayed. Select Restore Settings, then press ACT.
A message displays, giving you the option of restoring the pump settings that were saved on the given
date and erasing the ones currently on your pump. Read the instructions on the screen then press ACT
to restore the settings. You can press ESC if you want to cancel the restore.
The SETTINGS RESTORED message displays to confirm that your current pump settings have been replaced
with the pump settings you had saved on the given date. Exit the menus and check your pump settings
to verify the restore.
Utilities
147
Clearing the settings
Take the following steps only if you want to clear your pump to factory default settings.
WARNING: Do not clear your pump settings while it is connected to your body.
CAUTION: Do not clear your pump settings unless directed by your healthcare professional or a Medtronic
Diabetes representative. If you clear your pump settings, it will be necessary to reprogram all your
personal pump settings as directed by your healthcare professional. Additionally, you will have to rewind
your pump.
1
2
3
4
5
6
7
Go to the UTILITIES MENU screen and select User Settings.
Main > Utilities > User Settings
Hold down
and press ACT.
The USER SETTINGS screen is displayed. Select Clear Settings, then press ACT.
A CONFIRM message displays, giving you the option of clearing your pump settings or not. Select YES and
press ACT to clear the settings. You can press ESC if you want to cancel.
You will see a RESET screen, and then the pump will go through various screens while it restarts. After
the pump clears all of your settings, the screen will go to the TIME/DATE SETUP screen.
Reset the time and date as described in Setting the time and date section in the Basic programming
chapter.
After you set the time and date, you must rewind your pump. Refer to the Rewinding your pump section
in the Starting on insulin chapter for instructions. Remember, all your settings have been cleared and
you must either restore or reprogram all your settings.
History
If you want to view a listing of the dates and times of all recent User Settings operations you have done
on your pump, such as saves and restores, take the following steps:
1
2
3
4
148
Go to the UTILITIES MENU screen and select User Settings.
Main > Utilities > User Settings
Hold down
and press ACT.
The USER SETTINGS screen is displayed. Select History, then press ACT.
The SETTINGS HISTORY screen displays, giving you a list of all the dates and times of your most recent
User Setting operations. Scroll down to view the entire history. When you are done looking at the history,
press ESC to exit the menu.
Utilities
Therapy management software
Medtronic provides software to optimize your pump use. Contact our 24 Hour HelpLine for more information.
CareLink® Personal Software
Your pump provides real-time glucose values so that you can track glucose concentration patterns and
possibly identify episodes of low and high blood glucose. It also stores glucose data so that it can be analyzed
to track patterns or downloaded to CareLink Personal for analysis of historical glucose values.
•
•
•
•
•
It copies (uploads) data from your devices: insulin pump and supported blood glucose meters.
Device data is stored on a centralized database.
There is an online logbook where you can record self-reported information, such as how many
carbohydrates you consumed.
Uploaded data and other information stored on the system can be viewed through several different types
of treatment reports.
Access to data and personal information on this system is secure.
Chapter 10
CareLink Personal is a Web-based system designed to help you manage your diabetes. It has many key
features:
Reports
Reports show you data gathered from your device uploads, and from what you directly entered into the
system. Examples of the report data you can get include:
•
•
•
•
•
Pump operation, such as alarm settings and maximum allowed bolus amount.
Insulin delivery rates, types and times.
Blood glucose reading levels and times.
Sensor glucose reading levels and times.
Bolus Wizard or online logbook entry data.
Reports are displayed in PDF format. They can be viewed online, saved, or printed.
Therapy management software
149
You can share your reports with your healthcare professional. These reports can help you and your healthcare
professional to discover trends and other information. This can lead to improved therapy management for
greater control.
Logbook
The logbook allows you to enter the following self-reported information:
•
•
•
•
•
Carbohydrates consumed
Exercise activity
Urine ketone results
HbA1c results
Infusion set changes
The data from your logbook is used in the reports you create. You can see how, for example, your
carbohydrate intake compares to blood glucose levels for the same day or time. You can also use it as an
online diary of your diabetes management.
150
Therapy management software
Insulin pump therapy follow-up
We hope that you are now comfortable using the pump and your blood glucose values have improved through
insulin pump therapy. Diabetes management requires much more than blood glucose control. You need to
take care of your complete physical and mental health. This includes seeking treatment for any condition
both directly related to and not related to diabetes. The following recommendations apply to general
diabetes as well as insulin pump therapy follow-up. Remember, your healthcare professional is your best
resource for successful diabetes management.
Recommended follow-up
Everyday
Check blood glucose four to six times a day and always before bed.
Test before driving and have a fast-acting carbohydrate with you when you drive.
If your blood glucose is above 250 mg/dL (13.9 mmol/L) twice in a row, take an injection and change
the infusion set.
Every month
•
•
•
Chapter 11
•
•
•
Review DKA prevention guidelines.
Check 3:00 AM blood glucose at least once during the month.
Check two-hour post-meal blood glucose for all meals on a given day.
Every three months
•
•
•
Visit your healthcare professional, even if you feel well and your blood glucose values are within target
range.
Review your blood glucose log and insulin pump settings with your healthcare professional.
Make sure you have an HbA1c test done.
Insulin pump therapy follow-up
151
Laboratory tests
•
•
•
Test for HbA1c four or more times a year
Test for cholesterol, HDL, LDL, triglyceride yearly
Test for microalbuminuria yearly
Every visit
•
•
•
Blood pressure check
Foot exam
Review goals for blood glucose, meal plan and exercise
Annually
•
•
•
•
•
•
•
•
152
Dilated eye exam by a qualified eye care professional
Annual flu shot
Regular dental visits
Nerve function tests
EKG test over age 35
Prostate exam for men, breast exam for women
Diabetes education review
Replace Glucagon Emergency Kit (new prescription from your healthcare professional)
Insulin pump therapy follow-up
Troubleshooting, alerts and alarms
This chapter is designed to help you understand the messages that your pump is giving you when you get an
alarm or an alert message. The procedures in the beginning of this chapter are to be used when you get
specific alarms or cover a likely condition that might happen. A list of alarms is provided at the end of this
chapter.
NOTE: It is recommended that you read your warranty statement included with your pump for information
on what is covered during your warranty period.
My pump has a NO DELIVERY alarm
When a NO DELIVERY alarm occurs, it means that insulin delivery has stopped. Your pump is not broken, but
it has detected that something is preventing insulin from being delivered. Do the following steps:
1
2
3
4
Troubleshooting, alerts and alarms
Chapter 12
5
6
Check to see if your infusion set has become dislodged or kinked.
Check your blood glucose and follow your safety guidelines for treating high glucose if necessary.
Clear the alarm by pressing ESC and ACT. A screen appears with two choices: Resume and Rewind.
Make sure that there is insulin in your reservoir.
a. If you identified and fixed a kink in your tubing, select Resume.
b. If the reservoir is empty, select Rewind and change your reservoir and infusion set.
Monitor your blood glucose closely.
If you have followed these steps and receive another NO DELIVERY alarm, call our 24 Hour HelpLine.
153
What happens if I leave the pump battery out too long?
If you leave the pump battery out too long (more than five minutes) you may receive a BATT OUT LIMIT alarm
message when you install the new battery. Do the following steps:
1
2
3
Set your pump clock to the correct time, date, and year.
Check to make sure that all your settings, such as basal rate, are set as desired. If need be, reapply your
last saved settings to the pump by using the Restore Settings option under User Settings in the UTILITIES
MENU (you can only use this option if you have previously saved your pump settings). See the Restoring
the settings section in the Utilities chapter.
Check the ALARM HISTORY screen and the STATUS screen for any alarms and/or alerts that may still need
attention.
If you leave the battery out for more than three or four days, you may receive an A17 and A47 alarms when
you install a new battery. Do the following steps:
1
2
3
4
Clear the A17 and A47 alarms.
Set your pump clock to the correct time, date and year.
Check to make sure that all your settings, such as basal rate, are set as desired. If need be, reapply your
last saved settings to the pump by using the Restore Settings option under User Settings in the UTILITIES
MENU (you can only use this option if you have previously saved your pump settings). See the Restoring
the settings section in the Utilities chapter.
Check the ALARM HISTORY screen and the STATUS screen for any alarms and/or alerts.
Why doesn't my pump battery last very long?
A short battery life does not mean that something is wrong with your pump. Battery life in your pump is
variable and based on the conditions below:
•
•
•
•
•
•
154
The brand of battery you use (we recommend Energizer).
The storage and/or handling of the battery before use (avoid high or low temperatures).
The usage of pump in cold temperatures; this may shorten the battery life.
The usage of your pump, such as how often the buttons are pushed, the number of alerts/alarms and
set changes.
The amount of insulin the pump is delivering.
The usage of some features. The backlight, vibrate, sensor, remote control and meter options decrease
battery life.
Troubleshooting, alerts and alarms
What is a CHECK SETTINGS alarm?
This alarm occurs after an E alarm or after you clear your pump. It is advising you to make sure that all your
settings are correct. A CHECK SETTINGS alarm occurs after any of these actions:
•
•
•
All user settings were cleared (set back to their defaults) because there was an E-error alarm,
The Clear Settings function was performed, or
After you rewind when practicing without a reservoir when you first get your pump. In this case, it is
just a reminder to make sure all your settings are programmed before you begin using the pump with
insulin.
My screen appears distorted
The screen may appear distorted or have a rainbow-like appearance if you are wearing polarized sunglasses,
are in bright sunlight, or in extreme high or low temperatures. If your screen appears distorted:
•
•
•
•
Take off your sunglasses.
Move into the shade.
Make sure your pump is not in direct heat (next to a heater) or cold (worn on the outside of your clothing
on a very cold day).
Do not return the pump: this is a normal property of this type of screen on any device.
The pump is asking me to rewind
This is normal after any of the following:
Chapter 12
1
2
3
Any E-alarms,
The Clear Settings function,
Or, a NO DELIVERY alarm (during the Reservoir + Set sequence).
My bolus stopped
The Bolus Stopped error can occur if the battery cap is loose or the pump was bumped or dropped during a
bolus. It can also happen if the pump receives a static shock. As a safety measure, the pump stops the bolus
when this happens.
1
2
If you dropped your pump, visually inspect it to make sure that it is not damaged in any way.
Review your bolus history and reprogram the remaining bolus, if needed.
Troubleshooting, alerts and alarms
155
My pump buttons are not acting right during a bolus
If the
,
or
buttons are pressed and held down while a bolus is being delivered, the screen will
freeze on that amount. Once the button is released, the units will ramp up to the amount delivered so far.
Pressing and holding down the button will not stop the delivery of a bolus.
My pump will not display my blood glucose reading from my meter
1
2
3
4
5
6
7
8
Make sure you are using the correct meter (a blood glucose meter supported by MWT1 technology). Your
pump will communicate with this meter only.
Make sure your meter's RF (radio frequency) feature is on and working correctly.
Make sure the meter option in your pump is set to On and you have set the meter ID number correctly
on the pump.
Make sure your pump does not have a low battery alert condition.
Make sure the meter is within 4 feet (1.2 meters) of the pump without anything in between such as
another person, a wall, etc.
Make sure there is no RF (radio frequency) interference from other electronic devices that could prevent
communication. These devices can include some cell phones, cordless phones, televisions, computers,
radios, other Paradigm pumps, meters and pump remote controls. To restore communication, simply
move away from these other types of devices, or turn them off.
Your pump will not show another reading. Make sure the pump is idle and the HOME screen is blank.
If your pump still does not receive your blood glucose reading from the meter, use the up/down buttons
to manually enter your blood glucose (in the ENTER BG screen).
I dropped my pump
Take care to protect your pump from being dropped.
1
2
3
4
5
6
156
Check that all connections are still tightly in place.
Check the LCD, keypad and pump case for cracks or damage.
Check infusion set, including the tubing connector and tubing for cracks or damage.
Review the status screen, basal rates and other pump settings.
Perform the Selftest procedure located in the UTILITIES MENU.
Call our 24 Hour HelpLine for assistance.
Troubleshooting, alerts and alarms
I submerged my pump in water
Your pump is designed to resist accidental contact with water. Do not submerge in water during bathing,
swimming, or other water activities.
1
2
3
4
5
6
Pat the outside of the case until dry.
Open the reservoir compartment and check the compartment and reservoir for water. If wet, dry it
completely within 10 minutes of exposure to water. Exposure to liquids, including water or insulin can
corrode the mechanism.
Dry the reservoir completely—do NOT place a wet reservoir in the pump.
Do not use hot air to dry your pump. This may damage your pump's internal electronics.
Check the battery compartment and the battery—if wet, let them dry completely before using the pump.
Perform a selftest.
I cannot get to the USER SETTINGS screen
If you press ACT when you have User Settings highlighted, the following message appears: This feature is
not normally accessible. To access, consult your User Guide.
To get to the USER SETTINGS screen:
1
Go to the UTILITIES MENU screen.
2
3
Main > Utilities
Select User Settings. Hold down
and press ACT.
See the User settings section in the Utilities chapter for information about the menu options.
Chapter 12
Alerts
Your pump has a sophisticated network of safety checks and systems.
If it detects an unusual condition that requires your immediate
attention, it beeps or vibrates periodically to alert you. The pump goes
into Special mode (an open circle displays), and the backlight
illuminates.
Question: Why are alerts important?
Troubleshooting, alerts and alarms
157
Answer: Your pump monitors activities and will alert you if a Special mode is active. Some alerts are a normal
part of pump therapy, such as an active temporary basal. There are alerts that indicate a condition that is
outside normal pump activity. For example, your pump notifies you with an alert when you need to replace
the reservoir (LOW RESERVOIR) or replace your pump battery (LOW BATTERY).
It is important that you understand how your pump behaves when you do not clear an alarm or an alert:
•
•
Alarm — If you do not clear an alarm, the pump does not display any subsequent alarms or alerts until
the first alarm is cleared. After you clear the first alarm, the pump displays any subsequent alarms,
followed by any alerts in order of their importance.
Alert — If you do not clear an alert, the pump does not display any subsequent alerts until the first alert
is cleared. However, the pump displays an alarm even if you do not clear the alert. After you clear the
first alert or alarm, the pump displays any subsequent alarms or alerts in order of their importance.
Check your pump and test your blood sugar. Follow the guidelines prescribed by your healthcare professional
to manage your diabetes as needed.
Example:
John's pump displays a BUTTON ERROR alarm, but he does not clear it. During the time that his pump
displays the BUTTON ERROR alarm, his pump receives a LOW RESERVOIR alert. A few minutes later, his
pump receives a NO DELIVERY alarm. John's pump does not display the LOW RESERVOIR alert or the NO
DELIVERY alarm until he clears the first alarm. After John clears the BUTTON ERROR alarm, his pump
displays the NO DELIVERY alarm. After he clears the NO DELIVERY alarm, his pump displays the LOW
RESERVOIR alert.
What to do
When your pump beeps or vibrates notifying you that an alert condition exists:
1
2
3
4
158
Read and follow the instructions on the screen. Press ESC, ACT to clear the alert message.
Check the STATUS screen to determine what caused the alert.
If the condition is due to a low battery, replace the battery.
If the condition is due to a low reservoir, monitor the reservoir volume frequently and change the
reservoir when appropriate. Make sure you have a new reservoir, infusion set and vial of insulin with you.
Troubleshooting, alerts and alarms
Pump alert conditions
Listed below are alerts that indicate a condition that is outside normal pump activity.
LOW RESERVOIR
You can program the pump to sound an alert when either a specified number of units remains or a specified
amount of time remains before the reservoir will be empty.
LOW BATTERY
If you get this alert, do not go to sleep without replacing the battery. The backlight, the remote, and meter
functions are disabled during a LOW BATTERY condition. If the alert type is set to Vibrate, the pump will
change to the audio alert Beep-medium. Clear (ESC, ACT) this alert before you replace your battery.
Sensor alert conditions
Listed below are the alerts that you may encounter while using the sensor feature of your pump, and how to
resolve the alert condition.
WEAK SIGNAL
Action: Move the pump closer to the transmitter or move the transmitter and the pump to the same side of
your body.
Chapter 12
Reason: Occurs when the pump does not receive data from the transmitter for a pre-defined period of time
(as set in Weak Signal).
ALERT SILENCE
Reason: This alert screen displays when one or more glucose alerts occur during the time that the Alert
Silence feature is turned on.
Action: Press ESC, then ACT to clear the alert. Check the SENSOR ALERT HISTORY screen for the recorded
glucose alert information. See the Sensor alert history section in the Using your sensor chapter for details.
Troubleshooting, alerts and alarms
159
MISSED BOLUS
Reason: You have not delivered a bolus during the time period you specified in the Missed Bolus Reminder
feature.
Action: Set a meal bolus if needed.
LOST SENSOR
Reason: The pump has not received a signal from the transmitter. Do not disconnect the transmitter from
the sensor.
Action:
1
2
3
4
Make sure that the sensor is inserted correctly.
Check the REVIEW SETTINGS screen to make sure that the transmitter ID entered into the pump matches
the ID on your transmitter:
Main > Sensor > Review Settings
Check the transmitter and sensor connection. Touch the inserted sensor at the back of the assembly to
prevent movement and push the transmitter firmly:
a. If you hear a click, wait 20 seconds and look for a green light on the transmitter flash for 10 seconds
to confirm a good connection. If you see the green light, the alert was due to the transmitter and
the sensor not being connected.
b. If you hear a click, but do not see a green light on the transmitter, check to make sure that the
transmitter is charged.
c. If you do not hear a click when you check the connection, the alert was due to a transmission
problem. Bring the pump closer to the sensor and transmitter.
Use the Find Lost Sensor function to find your sensor (see the Troubleshooting sensor features section
in this chapter):
Main > Sensor > Link to Sensor > Find Lost Sensor
LOW TRANSMTR
Reason: Occurs when the transmitter battery is close to running out of power. This alert will repeat daily at
noon while this condition exists. The transmitter will continue sending sensor signals for several hours and
may last for several days until the battery becomes depleted. Be prepared to recharge your transmitter
immediately when its battery becomes depleted.
160
Troubleshooting, alerts and alarms
Action: Recharge your transmitter as soon as possible. See the Charging the transmitter section in the Sensor
features chapter.
CHARGE TRANSMTR
Reason: The transmitter battery is depleted.
Action: Recharge your transmitter immediately. See the Charging the transmitter section in the Sensor
features chapter.
CHANGE SENSOR
Reason: You may receive this alert after you receive two Cal Errors in a row, without the Cal Errors, or when
initializing your sensor.
Action: If the alert resulted from two Cal Errors in a row, replace the sensor. If the alert happened without
two Cal Errors, use the transmitter's tester to make sure your transmitter is working properly. If you received
this alert during initialization, you may be able to resolve this alert without replacing your sensor. Call our
24 Hour HelpLine for further assistance.
SENSOR END
Reason: The sensor has reached the end of its life.
CAL ERROR
Chapter 12
Action: Replace your sensor. The sensor has a maximum life of 72 hours (3 days). The 72-hour life span of
the sensor begins when the pump receives the first METER BG NOW alert.
Reason: An error occurred when entering a new meter BG measurement to calibrate the system. Some
possible causes are:
•
•
•
•
•
An incorrect blood glucose number was entered from the meter into the pump.
The entered blood glucose measurement was not current.
Your blood glucose is rising or falling rapidly.
The sensor needs more time to stabilize after being inserted.
The sensor is no longer reading the sensor glucose correctly.
Troubleshooting, alerts and alarms
161
Action: Follow the guidelines in the Calibrating the sensor section in the Sensor features chapter to enter
a new meter BG for calibration. If you receive a Cal Error on your second calibration, a CHANGE SENSOR alert
will occur. Call our 24 Hour HelpLine if you have questions.
METER BG NOW
Reason: A meter BG measurement is needed immediately to calibrate your sensor so that you can continue
receiving sensor glucose readings.
Action: Take and enter a meter blood glucose measurement. Follow the guidelines in the Calibrating the
sensor section in the Sensor features chapter.
METER BG BY
Reason: A meter BG measurement must be entered by the time that is shown to calibrate your sensor. The
METER BG BY alert is also known as the CAL REMINDER alert.
Action: Enter a blood glucose measurement to avoid a METER BG NOW alert.
LOW XX MG/DL (XX = SG measurement)
Reason: The sensor glucose number is equal to or lower than your low glucose limit. If you do not set a Low
Glucose Limit and do not set the glucose alerts ON, then you will not get a Low sensor glucose alert. The
pump plays four consecutive tones, in falling pitch, if an audible beep has been selected as the alert type.
HIGH XXX MG/DL (XXX = SG measurement)
Reason: The sensor glucose number is higher than or equal to your high glucose limit. If you do not set a High
Glucose Limit and do not set the glucose alerts ON, then you will not get a High sensor glucose alert. The
pump plays four consecutive tones, in rising pitch, if an audible beep has been selected as the alert type.
LOW PREDICTED
Reason: The sensor glucose measurements may reach or go below your Low Glucose Limit in the length of
time you selected for the Low Predictive alert. The pump plays three consecutive tones, in falling pitch, if
an audible beep has been selected as the alert type.
162
Troubleshooting, alerts and alarms
HIGH PREDICTED
Reason: The sensor glucose measurements may reach or go above your High Glucose Limit in the length of
time you selected for the High Predictive alert. The pump plays three consecutive tones, in rising pitch, if
an audible beep has been selected as the alert type.
RISE RATE
Reason: The sensor glucose measurements are rising at a rate that is equal to or faster than the Set Rise
Rate Limit you selected for the alert. The pump plays two consecutive tones, in rising pitch, if an audible
beep has been selected as the alert type.
FALL RATE
Reason: The sensor glucose measurements are falling at a rate that is equal to or faster than the Set Fall
Rate Limit you selected for the alert. The pump plays two consecutive tones, in falling pitch, if an audible
beep has been selected as the alert type.
SENSOR ERROR
Reason: The sensor signals are either too high or too low.
Alarms
Your pump has a sophisticated network of safety checks and systems. If the safety network detects anything
unusual, your pump notifies you of conditions that require your immediate attention. The backlight
illuminates the pump screen and the alarm message displays on the screen.
Chapter 12
Action: You do not need to change the sensor. Clear the alert. If the alert persists, test your transmitter
with the tester.
It is important that you understand how your pump behaves when you do not clear an alarm or an alert. See
the Alerts section in this chapter for an explanation and an example.
Check your pump and test your blood sugar. Follow the guidelines prescribed by your healthcare professional
to manage your diabetes as needed.
Troubleshooting, alerts and alarms
163
NOTE:
The STATUS screen shows any alarms and alerts that are active.
Question: Why are alarms important?
Answer: Your pump monitors activities and notifies you if there is an unusual pump status or your attention
is required. When an alarm is active, INSULIN DELIVERY IS STOPPED and immediate operator interaction is
required.
If the vibrate mode is on, all alarms and alerts start as vibrations and
then change to beeps. For your safety, if there is no response after
10 minutes, the beeps change to a siren. The siren continues every
minute until the alarm is cleared.
What to do
When a solid circle appears, follow
the instructions on the screen
When an alarm is triggered, the pump goes into Attention mode and an
alarm message shows on the screen. The pump then defaults to the
HOME screen. Do these steps when you get an alarm:
1
2
View the alarm: From the HOME screen, press any button to see the alarm message.
Read all of the alarm text. There are instructions on how to fix the alarm condition. (Press
3
4
5
6
more text, if available.)
Clear the alarm. Press ESC then ACT after you read the alarm instructions.
The HOME screen appears.
Follow the instructions that appeared with the alarm to fix the alarm condition.
Check your settings. Check your time, date, basal and other settings to make sure they are correct.
to read
Alarm conditions
Alarms put the pump in Attention mode.
A (ALARM)
This alarm shows the letter A followed by two numbers. A-alarms cause all insulin delivery to stop. Your
pump settings are retained. If this alarm repeats often, call our 24 Hour HelpLine for assistance.
164
Troubleshooting, alerts and alarms
AUTO OFF
Alerts you that no buttons were pressed during the time limit you set for the AUTO OFF DURATION feature,
and so insulin delivery has been stopped.
BATT OUT LIMIT
Occurs if the battery has been out of the pump for more than five minutes. Verify that the pump time and
date are correct. If not correct, go to the UTILITIES MENU and reset the date and time.
BOLUS STOPPED
If this alarm occurs, it is very important to check bolus history to review how much of the bolus was actually
delivered. If necessary, reprogram a bolus with the amount not yet delivered.
BUTTON ERROR
Occurs if a button has been continually pressed for more than three minutes.
CHECK SETTINGS
When this alarm is active, you should check and/or reprogram your pump settings, including the time/date.
An E-error alarm will show the letter E followed by two numbers. E-alarms cause all insulin delivery to stop,
the pump resets, and all your settings are cleared. After receiving this alarm, note the error number then
call our 24 Hour HelpLine for assistance.
Troubleshooting, alerts and alarms
Chapter 12
E (ERROR)
165
EMPTY RESERVOIR
There is no insulin in the reservoir. Change the reservoir immediately.
FAILED BATT TEST
The pump tests the voltage of each battery installed. This test ensures a battery with low voltage is not used.
If the battery does not have enough voltage, this alarm will occur. The pump will not function and the battery
must be replaced. (Always make sure that you install a NEW battery into the pump.)
FINISH LOADING
You have not completed filling the infusion set with insulin. Clear the alarm. This resumes basal delivery.
See the Filling the cannula section in the Starting on insulin chapter to fill the infusion set cannula with
insulin. If your infusion set has a needle cannula, press ESC to skip this step.
MAX FILL REACHED
If you use more than 30 units of insulin to fill the infusion set tubing, this message appears. Press ESC, ACT
to clear the message. See the Filling the tubing section in the Starting on insulin chapter for more
information.
166
Troubleshooting, alerts and alarms
MAX DELIVERY
This alarm alerts you when you have taken more insulin than expected based on Maximum bolus and Maximum
basal rates.
MOTOR ERROR
Insulin delivery has stopped. This alarm occurs if your pump detects a motor error.
NO DELIVERY
Insulin delivery has stopped. This alarm will occur if your pump detects a blockage or if the reservoir is empty.
Refer to the first page of the Troubleshooting chapter for additional information.
NO RESERVOIR
The reservoir is not inserted correctly or no reservoir has been inserted.
OFF NO POWER
The battery is dead. Replace battery immediately. Follow the directions on the screen. Check to make sure
that the time is correct on the screen. Reset the time if necessary.
The Reset alarm triggers when pump settings are cleared because of one of these reasons:
•
•
Chapter 12
RESET
Pump settings were cleared (Clear Settings function) and settings have not been reprogrammed.
A download attempt from the PC is incomplete. (The download function is applicable to the optional
software feature. Refer to the software user guide for more information.)
WEAK BATTERY
The pump tests the voltage of each battery installed. If the battery voltage is less than full strength, this
alarm may occur. The pump will operate normally, but the battery life will be shorter than expected. Always
make sure to install a new battery in the pump.
Troubleshooting, alerts and alarms
167
Testing the transmitter
The tester acts like a sensor. If you get sensor-related alerts, use the tester to make sure that the transmitter
is working.
Connecting the tester
1
Hold the transmitter and the tester as shown. Line up the flat side of the tester with the flat side of the
transmitter.
2
Push the tester into the transmitter until the flexible side arms of the tester click into the notches on
both sides of the transmitter.
Within 20 seconds, the green light on the transmitter will flash for about 10 seconds when properly
connected. The Sensor feature must be turned On on your pump. Go to the RECONNECT OLD SENSOR
screen to start your sensor.
3
Main > Sensor > Link to Sensor > Reconnect Old Sensor
You should see the sensor icon
4
on the pump screen, which means that the transmitter and the sensor
are communicating.
Within the next seven to eight minutes, go to the SENSOR STATUS screen to look for the Sensor ISIG value:
a. The sensor ISIG value on this screen should be between 24.00–29.00 nA. This range of ISIG values
means that the transmitter electronics are working properly. Since the transmitter is sending signals
correctly, the sensor must have caused the alert. Remove and discard the sensor. Insert a new sensor
in a new site.
b. If you see a Sensor ISIG value that is less than 24.00 nA or more than 29.00 nA, contact our 24 Hour
HelpLine. It may be time to replace your transmitter.
168
Troubleshooting, alerts and alarms
Disconnecting the tester
1
Hold the transmitter body as shown and pinch the side arms of the tester.
2
With the tester arms pinched, gently pull the transmitter away from the tester. To save transmitter
battery life, do not leave the tester connected after testing.
Troubleshooting sensor features
Reconnect old sensor
You should only use this feature if you have disconnected the sensor from the transmitter and have to
reconnect them.
1
Go to the RECONNECT OLD SENSOR screen.
2
3
Main > Sensor > Link to Sensor > Reconnect Old Sensor
Press ACT in the RECONNECT OLD SENSOR screen.
The SENSOR READY 2 HRS screen appears. Press any button to continue. An alert will sound in two hours
when a meter BG is required for calibration.
Troubleshooting, alerts and alarms
Chapter 12
To Reconnect old sensor:
169
Find lost sensor
If you receive a Lost Sensor alert:
170
1
Relocate the pump closer to the sensor, and go to the LINK SENSOR MENU.
2
3
Main > Sensor > Link to Sensor
Select Find Lost Sensor, then press ACT.
The SENSOR READY 15 MIN screen appears. Press any button to continue. An alert will sound in 15 minutes
when a meter BG is required for calibration.
Troubleshooting, alerts and alarms
Maintenance
It is recommended that you read your warranty statement included in this user guide for information about
what is covered during your warranty period.
Battery
The Paradigm pump uses a single 1.5 V AAA alkaline battery, size E92, type LR03. As a safety measure,
Medtronic Diabetes has designed the pump to only accept a NEW battery. If you insert a used battery, the
FAILED BATT TEST alarm may be triggered. Refer to the Install battery section in The basics chapter for
instructions.
The use of cold batteries causes erratic pump behavior. To prevent this, do not use batteries that have been
in cold storage (such as in the refrigerator or your car in the winter). It takes several hours for these batteries
to warm to room temperature.
Certain features on the pump use a lot of battery power. Your battery will need to be replaced more
frequently if you use these features:
•
•
•
•
Remote control
Meter
Backlight
Vibrate alert type setting
CAUTION: It is recommended that you use a AAA Energizer battery. Do not use a rechargeable or carbon
zinc battery in the pump. Do not remove the battery unless you are changing your battery (installing a
NEW battery). Replace it within five minutes. If not replaced within five minutes, the screen may display
an alarm message. Follow the instructions in the message and make sure the time and date are set
correctly. Check that the battery is inserted correctly. If the battery has been installed backwards,
remove the battery and install it properly.
Chapter 13
Maintenance
171
Storage
If you have to remove and store your pump, it is recommended that you store it with the battery in place.
Keep a record of your current basal rates. To preserve battery life, reset the basal rates to 0 (zero), turn off
the remote and meter options, and set the Auto-off to dashes or zeroes.
Cleaning your pump
1
2
3
4
5
6
7
8
9
Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump.
Rinse the pump with a clean cloth, dampened with clean water.
Dry with a clean cloth.
Never use organic solvents, such as lighter fluid, nail polish remover, or paint thinner to clean your pump.
Keep the reservoir compartment and battery compartment dry and away from moisture.
Do not use any lubricants with your pump.
Use a 70 percent alcohol wipe to disinfect your pump.
Use a dry clean cotton tip to remove any battery residue from the battery cap.
Use a dry clean cloth to remove any battery residue from the battery compartment opening.
Cleaning the transmitter
CAUTION: The charger and the tester are NOT water-tight. Do NOT immerse in water.
Do NOT discard the transmitter in a medical waste container or otherwise subject it to incineration.
Transmitter contains a battery which may explode upon incineration.
1
2
3
4
5
172
Wash your hands thoroughly.
Dampen a clean cloth with mild liquid soap and warm water. Wipe the outside of the transmitter.
Rinse the transmitter under warm tap water but do not get water inside the connector. If you get water
inside the connector, shake the water out and allow it to air dry.
Using an antibacterial hand-sanitizer (available at a local drugstore) on a clean, dry cloth, wipe the
transmitter’s surface. Do NOT get any hand-sanitizer inside the connector. Repeated exposure to the
hand-sanitizer could damage the connectors and affect the transmitter’s performance as a result. If you
get hand-sanitizer inside the connector, allow it to air dry.
Place the transmitter on a clean, dry cloth and air dry for 2-3 minutes.
Maintenance
Cleaning the Sen-serter
1
2
3
4
5
6
Wash your hands thoroughly.
Dampen a clean cloth with mild liquid soap and warm water. Wipe the Sen-serter.
Rinse with warm tap water.
Using an antibacterial hand sanitizer (readily available at your local drugstore), wipe down the Senserter.
Place the Sen-serter on a clean dry cloth and allow to air dry.
Store the Sen-serter in the released position to maintain optimum product performance and life.
Chapter 13
Maintenance
173
174
Maintenance
Pump specifications
This section provides detailed information on specifications related to your pump. The safety features of
your pump are individually listed and described.
Alarms and error messages
•
•
Indicators: audible tone (beep) or vibration (silent).
All alarms and errors show messages on the pump's screen and provide instructions on what to do.
Unresolved alarms will escalate to siren mode for added safety.
Alarm history
Maximum records shown: 36
Audio frequency
Frequency (+/- 25%)
Alarm
1850 Hz
Escalated alarm
2.5 kHz, followed by 3.2 kHz
Alert
1.8 kHz, followed by 2.1 kHz and 1.8 kHz
High Glucose alert
2.5 kHz, followed by 2.79 kHz, 2.98 kHz and 3.2 kHz
Low Glucose alert
3.2 kHz, followed by 2.98 kHz, 2.79 kHz and 2.5 kHz
Predictive High Glucose alert
2.5 kHz, followed by 2.98 kHz and 3.2 kHz
Predictive Low Glucose alert
3.2 kHz, followed by 2.98 kHz and 2.5 kHz
Rising rate of change alert
2.5 kHz, followed by 3.2 kHz
Falling rate of change alert
3.2 kHz, followed by 2.5 kHz
Chapter 14
Name
Pump specifications
175
Backlight
•
•
LCD (Liquid Crystal Display) type
Time-out: 30 seconds
Basal
•
•
•
•
Delivery: 0.025–35 units/hour (maximum units: 35/hour)
Factory maximum setting: 2.0 units/hour
3 patterns maximum, each with 48 rates
Increments:
•
0.025 units for basal amounts in the range of 0.025 to 0.975 units
•
0.05 units for basal amounts in the range of 1 to 9.95 units
•
0.1 units for basal amounts of 10.0 units or larger
BG Target
Maximum targets: 8
•
•
Range: 60–250 mg/dL (3.3–13.9 mmol/L)
Warning limits: less than 90 or greater than 140 mg/dL (less than 5.0 or greater than 7.8 mmol/L)
Bolus delivery
•
•
Insulin delivered/stroke:
•
0.025 units for bolus amounts in the range of 0.025 to 0.975 units
• 0.05 units for bolus amounts larger than 0.975 units
Fluid delivered/stroke: 0.25 µL (microliter) for 0.025 unit pump stroke; 0.5 µL for 0.05 unit pump stroke
Maximum bolus
•
Range: 0.0–25.0 units
Bolus history
Maximum records shown: 24
176
Pump specifications
Bolus units
Increments: Based on selected scroll rate
Bolus Wizard feature
See the Bolus Wizard feature specifications section in this chapter for information.
Carb ratios
Maximum ratio settings
8
Range
Warning limits
1–200 grams/u
less than 5 or greater than 50 grams/u
0.075–
15.0 u/exch
less than 0.3 or greater than 3.0 u/exch
Carb units
The food entry when using Bolus Wizard feature:
•
•
grams: 0–300 (increments: 1 gram)
exchanges: 0.0–20 (increments: 0.5 exch)
Daily totals
Maximum records shown: 32 days of data, maximum display: 999.975 units/day. Daily delivery accuracy:
0.025 units.
Default screen
The HOME screen. For most screens, if no buttons are pressed for 30 seconds, the pump returns to this screen.
Chapter 14
Pump specifications
177
Delivery accuracy
•
•
•
Testing has confirmed that the delivery accuracy for the maximum/minimum bolus/basal amounts are
within the +/-5 percent of the programmed value.
All normal boluses will be delivered within a maximum of six minutes.
Displacement (piston) accuracy: +/-2 percent.
Delivery Volume Accuracy Curve (-1.20%) Overall Error
(MMT-523 Model) QTP6303 Qualification Pump (0.01 ml/hr 10/22/07 S/N: PAR162804U); 23°C,
MMT-326A Reservoir Lot#: WE0107318, MMT-317 Infusion set Lot: 620699
20
Maximum Error (percent)
15
Minimum Error (percent)
Overall Flow Error (percent)
Percent Error (%)
10
5
0
0
15
30
45
60
75
90
105
-5
-10
-15
-20
Time Interval (Minutes)
Pump motor
The pump motor has a unique, patented design with an integrated safety check system. The system delivers
in precise increments.
178
Pump specifications
Dual Wave bolus
Delivers a Normal bolus followed by a Square Wave bolus (limited by maximum bolus).
Easy bolus
•
•
•
•
•
•
Features programming using audible tones (or vibrate pulses) in user-defined increments.
• Beep mode range: 0 to maximum bolus
• Vibrate mode range: 0 to 20 steps or maximum bolus, whichever comes first
Factory default: off
Default step increment: 0.1 unit
Step size ≤ maximum bolus.
Adjustable step size: 0.1 to 2.0 units per step.
Accessible from the remote control or pump buttons.
Filling the infusion set
•
•
•
•
Filling the cannula: up to 10 units (limited by maximum bolus)
Filling the tubing: warning at 30 units, then at each 10 units thereafter.
Fill rate: 1 to 5 units/second.
Insulin used to fill the infusion set is not counted in daily totals but is recorded separately in the Reservoir
+ Set history.
Infusion pressure
Maximum infusion pressure and occlusion pressure: 13.7 PSI (94.46 kPa).
Insulin sensitivity
•
•
•
•
Maximum settings: 8
Factory default: 50 mg/dL/u (2.8 mmol/L/u)
Range: 10–400 mg/dL/u (0.5–22.2 mmol/L/u)
Warning limits: less than 20 or greater than 100 mg/dL/u (less than 1.1 or greater than 5.6 mmol/L/u)
Chapter 14
Pump specifications
179
Low resv (reservoir) warning
Values are based on displayed amount, not actual amount.
time:
2–24-hours, and @ 1:00 hour before
empty
08:00 hours (default when time is
selected)
units:
5–50 units, and @ half of the
remaining amount
20 units (factory default)
Meter value
The BG measurement received from the meter. Appears in the ENTER BG screen during bolus programming.
Appears on the screen when the pump is idle at the HOME screen.
•
•
•
Expiration: 12 minutes
Range: 20–600 mg/dL (1.1–33.3 mmol/L)
Maximum meter ID entries: 3
Normal bolus
Range 0.025 - 25.0 units of insulin (limited by maximum bolus setting).
Occlusion detection
When occlusion is detected, the NO DELIVERY alarm occurs. The occlusion alarm is triggered by an average
of 2.77 units of missed insulin. The Paradigm pump is intended for use with U100 insulin. This table shows
occlusion detection for three different situations when using U100 insulin.
Rate
Typical time
before alarm
Maximum time
before alarm
bolus delivery (10 units at 2 u/min)
28 seconds
49 seconds
72 seconds
basal delivery (1.0 u/h)
1.95 hours
3.26 hours
4.9 hours
basal delivery (0.025 u/h)
27 hours
112.47 hours
179 hours
Percent temp basal
Default value: 100% of basal programming
180
Minimum time
before alarm
Pump specifications
Power supply
The pump is powered by a standard 1.5 V AAA alkaline battery, size E92, type LR03 (Energizer brand
recommended).
Reservoir + Set history
Maximum records shown: 20 (fill tubing and fill cannula)
Program safety checks
Maximum infusion with single fault condition: 0.0 units
Pump size
The dimensions of the pump are approximately:
•
•
523/523K pumps:
•
2.0 x 3.3 (2.8 at the battery cap) x 0.82 inches
•
5.1 x 8.3 (7.1 at the battery cap) x 2.0 cm
723/723K pumps:
•
2.0 x 3.7 (3.5 at the battery cap) x 0.84 inches
•
5.1 x 9.4 (8.9 at the battery cap) x 2.1 cm
Pump weight
•
•
523/523K pumps: approximately 95 grams (with battery installed).
723/723K pumps: approximately 102 grams (with battery installed).
Remote control
Uses radio signals to allow users to program Normal boluses or to suspend/resume their pumps.
•
•
•
The user-filled reservoir is made from impact-resistant, insulin-compatible polypropylene.
523/523K pump volume: up to 176 units of U100 insulin
723/723K pump volume: up to 300 units of U100 insulin
Pump specifications
Chapter 14
Reservoir
181
Square Wave bolus
Delivers bolus insulin over a duration of 30 minutes up to eight hours (limited by the Max bolus setting).
Temporary (temp) basal rate
Allows you to temporarily change the current basal rate for a duration of 30 minutes up to 24 hours (limited
by Maximum basal setting). The temp basal rate can be set to either Percent of basal or Insulin rate.
Time and date screen
12-hour or 24-hour formats. Pump users set the time/date, including the year, month and day. The date is
included in the STATUS screen. Time always appears on the top of the screen.
Environmental conditions
•
•
•
Pump operating temperature range: from 37°F (3°C) to 104°F (40°C)
Air pressure range: from 700 hPa to 1060 hPa (from 10.2 psi to 15.4 psi)
Operating humidity range of the case: 20% to 95%. This requirement exceeds EN 60601-2-24:1998, Section
10.2.1b (20% to 90%).
Status screen
Item
182
When
What
Active Insulin
(if any)
(Active Ins:) the amount of active
insulin, displayed to the next 0.025 U
Alarm Clock*
(appears if scheduled to
alarm)
Time set is displayed.
Alert Silence
(if active)
Hi, Lo, Hi/Lo, All with time left
Auto-off
(appears if enabled)
X HR
Basal pattern information
(if active)
Pattern A or B
Battery Status
(always appears)
Normal, Low, Off
BG meter value
(most recent BG value
received)
(appears if BG meter is
enabled)
XXX mg/dL (XX.X mmol/L) time and date
received
Pump specifications
Item
When
What
BG Reminder*
(Only if enabled)
Time remaining before BG Reminder is set to go off H:MM h
(if less than 1 hour, 0:XXh where XX is minutes remaining)
Block
(if active)
Current date
(always appears)
Current temp basal
information
(if active)
rate (units per hour), duration, time
remaining
Last alarm/alert
(if cleared within 24 hours)
(Last:) with the date, time and
abbreviation for the most recently
cleared alarm/alert
Last bolus information
(appears if at least one bolus
was started)
type and units delivered
ON
delivery time and date
(S = Square, N = Normal, DN = Normal
part of dual wave bolus, DS = Square part
of dual wave bolus)
Meter: Disabled
(appears if enabled but battery is low or empty)
Meter: On
(appears if enabled)
Missed Bolus Reminder
(if this feature is turned on)
Pump model number
(always appears)
Remote: Disabled
(appears if enabled but battery is low or empty)
Remote: On
(appears if enabled)
Reservoir started
(always appears)
Serial number
(always appears)
Sensor Demo
(if Demo Mode is selected for
the sensor graphs)
Software version
(always appears)
Standard basal delivery data
(always appears)
Status of pump
(such as Rewind, Suspended, Low Reservoir, Set Time, and so on)
Bolus Before and the time that the
reminder is due
date, time, units left, time left
SENSOR DEMO: On
Pump specifications
Chapter 14
current basal rate (basal 1, basal 2, etc.)
183
Item
Time
When
What
(always appears)
*If all of the Reminders and the Alarm Clock are enabled, only the reminder that is nearest to alarming
will appear in the STATUS screen.
Bolus Wizard feature specifications
There are four different formulas the Bolus Wizard feature uses to estimate a bolus, depending on your
current BG. The following formulas apply only when the carb units are in grams.
1
2
3
4
184
If your current BG is greater than your High BG Target, the Bolus Wizard feature subtracts active insulin
from the BG correction estimate, then adds this to the food estimate to get the total bolus estimate.
However, if the result of subtracting active insulin from BG correction estimate is a negative number
(less than zero), the total bolus estimate is based only on the food estimate.
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
Correction estimate:
(Current BG - High BG Target) ÷ Insulin sensitivity - Active insulin = Units of insulin
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
If your current BG is less than your Low BG Target, the Bolus Wizard feature adds the BG correction
estimate to the food estimate to get the total bolus estimate.
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
Correction estimate:
(Current BG - Low BG Target) ÷ Insulin sensitivity = Units of insulin
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
If your current BG is between or equal to your High or Low BG Target, the total bolus estimate is based
only on the food estimate.
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
Total bolus estimate = Food estimate
If you do not enter a BG, the total bolus estimate is based only on the food estimate.
Pump specifications
NOTES:
•
If a Dual Wave bolus is less than the estimate due to the max bolus limit or a user change, the square
(sq) portion is reduced first.
•
Based on the Active Insulin Time setting you choose, the pump
keeps track of how much insulin is still active in your body. This is
shown as Active Ins. or Act. Ins. in the STATUS, SET BOLUS, SET
NORMAL BOLUS, SET SQUARE BOLUS, SET DUAL BOLUS TOTAL, and
SET EASY BOLUS screens. This prevents stacking of insulin, and
lowers the chances of hypoglycemia.
The active insulin amount is also shown in the Bolus Wizard’s ESTIMATE DETAILS screen but is calculated
differently than in the above screens. The active insulin amount calculated in the ESTIMATE DETAILS
screen includes the insulin that has already been delivered and insulin that is going to be delivered by
the active Square Bolus. To show this difference in calculation, the active insulin appears with an
asterisk (*Active Insulin) in this screen.
•
Chapter 14
Pump specifications
185
•
The Bolus Wizard feature may utilize your current BG measurement, carbohydrate consumption, and
active insulin to calculate your estimated bolus.
Active Insulin Curves
•
Active Insulin Curve
100%
90%
8 Hour
80%
7 Hour
6 Hour
5 Hour
70%
4 Hour
% Insulin Remaining
3 Hour
2 Hour
60%
50%
40%
30%
20%
10%
0%
0
1
2
3
4
5
6
7
8
9
Time (hours)
Graph adapted from Mudaliar and colleagues, Diabetes Care, Volume 22, Number 9, Sept. 1999, page 1501.
186
Pump specifications
Bolus Wizard feature examples
Settings:
•
•
•
•
1
2
3
Pump specifications
Chapter 14
Carb ratio: 30 grams/unit
BG Target: 90–120 mg/dL (5.0–6.7 mmol/L)
Insulin Sensitivity: 40 mg/dL/unit (2.2 mmol/L/unit)
Active Insulin Time: 6 Hours
No active insulin from previous bolus delivery. User inputs 60 grams of carbs and does not enter BG.
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 30 g/u = 2 units
Total bolus estimate = Food estimate = 2 units
No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 200 mg/dL
(11.1 mmol/L).
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 30 g/u = 2 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 - 6.7 mmol/L) ÷ 2.2 mmol/L/u = 2 units
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
2 units + 2 units = 4 units
No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 70 mg/dL
(3.9 mmol/L).
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 30 g/u = 2 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:
187
4
5
6
188
Food estimate + Correction estimate = Units of insulin
2 units + (-0.5) units = 1.5 units
No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 100 mg/dL
(5.6 mmol/L).
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 30 g/u = 2 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
2 units + 0 units = 2 units
Previous bolus activity results in a calculation of 1.5 units unabsorbed (active) insulin. User inputs
60 grams of carbs and a BG of 200 mg/dL (11.1 mmol/L).
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 30 g/u = 2 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 - 6.7 mmol/L) ÷ 2.2 mmol/L/u - 1.5 units = 0.5 units
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
2 units + 0.5 units = 2.5 units
Previous bolus activity results in a calculation of 3.5 units unabsorbed (active) insulin. User inputs
60 grams of carbs and a BG of 200 mg/dL (11.1 mmol/L).
Food estimate:
Carb grams ÷ Carb ratio = Units of insulin
60 g ÷ 30 g/u = 2 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 - 3.5 units = -1.5 units*, or
(11.1 mmol/L - 6.7 mmol/L) ÷ 2.2 mmol/L/u - 3.5 units = -1.5 units*
Pump specifications
NOTE: *This negative number indicates that active insulin is sufficient to cover the correction that
is needed. Thus, correction is 0 units. Active insulin does not reduce the food portion of the estimate.
Total bolus estimate:
Food estimate + Correction estimate = Units of insulin
2 units + 0 units = 2 units
Insulin delivery default settings
Menu
Bolus Menu:
Item
Default
Setting
Bolus Wizard feature:
Off
Easy bolus:
Off
Easy bolus step:
Scroll Rate:
Dual/Square bolus:
Maximum bolus:
Basal Menu:
0.1 u
Limits
2.0 u
0.10 u
Increments
0.1 u
0.025 u; 0.05 u; 0.10 u
Off
10.0 u
0.0–25.0 u (per
single bolus)
BG Reminder:
Off
0:00 - 5:00
0:30
Patterns:
Off
0.000–35.0 u/h
0.025 u (for 0.025–
0.975 u/h); 0.05 u (for
1.00–9.95 u/h); 0.1 u (for
rates of 10 u/h or more)
Maximum basal rate:
Basal rate:
0.000 u/h
U/H
0.025 u (for 0.025–
0.975 u/h); 0.05 u (for
1.00–9.95 u/h); 0.1 u (for
rates of 10 u/h or more)
Max basal rate
setting
0.025 u (for 0.025 0.975 u/h); 0.05 u (for
1.00 - 9.95 u/h);0.1 u (for
rates of 10 u/h or more);
(or 1%)
Pump specifications
Chapter 14
Temp basal type:
2.00 u/h
189
Menu
Utilities Menu:
Item
Default
Setting
Lock Keypad:
(no defaults)
Alert type:
audio, beepmed
Auto-off:
Off
Capture Option:
Off
190
Pump specifications
(20) insulin
units
(Time/Date) Time:
12 a.m.
(midnight)
(Time/Date) Date:
1/1/07
(Time/Date) Time
format:
12-hour
Block:
Off
Alarm clock:
Off
Remote option:
Off
Meter option:
Off
User Settings:
(no defaults)
Language:
Increments
Off
(Alarm) History:
Low reservoir warning:
Limits
English
if units: 1st @ 5–
50 u; 2nd @ half
amount
remaining
(if time: 1st @
2:00–24:00; 2nd
@ 1:00 hour
before empty)
20 u
(0:30)
Bolus Wizard feature default settings
Item
Default
Setting
Limits
Increments
Warning Limits
—
—
—
carb units:
grams
ins to carb (or
exch) ratio:
15 grams/u or
1 unit/exch
1–200 g/u or 0.075–
15.0 u/exch
0.1 g/u for 0–9.9 g/u; 1 g/u
for ratios of 10.0 g/u or
more
(or 0.001 u/exch for 0.075–
0.099 u/exch; 0.01 u/exch
for 0.10–9.99 u/exch;
0.1 u/exch for 10.0–
15.0 u/exch)
5–50 g/u or 0.3–
3.0 u/exch
(insulin)
sensitivity:
50 mg/dL/u
or
2.8 mmol/L/
u
10–400 mg/dL/u or
0.5–22.2 mmol/L/u
1 mg/dL/u or 0.1 mmol/L/
u
20–100 mg/dL/u
or 1.1–
5.6 mmol/L/u
BG Target:
100–
100 mg/dL or
5.6–
5.6 mmol/L
60–250 mg/dL or 3.3–
13.9 mmol/L
1 mg/dL or 0.1 mmol/L
90–140 mg/dL or
5.0–7.8 mmol/L
Active Ins Time:
6 hours
2–8 hours
1 hour
—
Sensor features default settings
Feature
Options
Default Setting
Limits, Range of Values
Sensor
•
•
On
Off
Off
Glucose Alerts
•
•
On
Off
Off
Glucose Limits
•
•
Maximum of 8 Glucose Limits.
One pair of Glucose Limits (Glucose Limits 1) is already set up for you, with a
default High Glucose Limit and Low Glucose Limit.
Glucose Limits 2 through 8 can be set as needed.
Set the limits using the
Glucose Limits feature.
Pump specifications
Chapter 14
•
—
191
Feature
Options
Glucose Limits 1
523, 723
• Low:
80 mg/dL (4.4 mmol/L)
• High:
240 mg/dL (13.3 mmol/L)
523K, 723K
•
•
Low:
90 mg/dL (5.0 mmol/L)
High:
280 mg/dL (15.5 mmol/L)
Default Setting
523, 723
Low:
80 mg/dL
(4.4 mmol/L)
Limits, Range of Values
Low Glucose Limit range:a
• 523, 723: 40–390 mg/dL
(2.2–21.6 mmol/L)
• 523K, 723K: 90–
390 mg/dL (5.0–
21.6 mmol/L)
High:
240 mg/dL
(13.3 mmol/L)
High Glucose Limit range:b
523K, 723K
•
Low:
90 mg/dL
(5.0 mmol/L)
•
523, 723: 50–400 mg/dL
(2.8–22.2 mmol/L)
523K, 723K: 100–
400 mg/dL (5.6–
22.2 mmol/L)
High:
280 mg/dL
(15.5 mmol/L)
192
Glucose Limits 2
through
Glucose Limits 8
•
•
High Repeat
• On
• Off
(Set to On when High Glucose,
High Predictive, or Rising Rate
of Change Alert is on)
On
1 hour
Range:
0:05–3:00 (5 minutes to
3 hours)
Low Repeat
• On
• Off
(Set to On when Low Glucose,
Low Predictive, or Falling Rate
of Change Alert is on.)
On
20 minutes
Range:
0:05 – 1:00 (5 minutes to
1 hour)
Pump specifications
Low: Off
High: Off
Low
Off
High
Off
See the Glucose Limits 1
range.
Feature
Options
Default Setting
Limits, Range of Values
Predictive Alert
•
•
On
Off
Off
Default time
sensitivity:
Low
15 minutes
High
15 minutes
Range:
Off
0:05 – 0:30 (5 to 30 minutes)
Rate of Change
Alerts
•
•
On
Off
Fall Rate Limit
Off
Fall Rate Limit range:
1.1–5.0 mg/dL/min (0.065–
0.275 mmol/L/min)
Rise Rate Limit
Off
Rise Rate Limit range:
1.1–5.0 mg/dL/min (0.065–
0.275 mmol/L/min)
Cal Repeat
(Always on - cannot be turned
off)
On
30 minutes
Range:
0:05 – 1:00 (5 minutes to
1 hour)
Cal Reminder
•
•
On
Off
On
1 hour
Range:
0:05 – 6:00 (5 minutes to
6 hours)
Blood Glucose
Units (BG Units)
•
•
mg/dL
mmol/L
mg/dL
Weak Signal
(Always on - cannot be turned
off)
30 minutes
Range:
0:05 – 0:40 (5 to 40 minutes)
Sensor glucose
graph timeout
•
•
•
•
2 minutes
—
2 minutes
4 minutes
6 minutes
NONEc
—
Chapter 14
Pump specifications
193
Feature
Options
Alert Silence
•
•
•
•
•
AUC Limits
Always on
a.
Off
Hi Alerts
Lo Alerts
Hi and Lo Alerts
All Sensor Alerts
Default Setting
Limits, Range of Values
Off
If any option other than Off
is selected in the ALERT
SILENCE screen, the SET
DURATION screen displays.
The value range is from
00:30 to 24:00.
Low Limit
70 mg/dL
(3.9 mmol/L)
Low Limit range:d
40–400 mg/dL (2.2–
22.2 mmol/L)
High Limit
180 mg/dL
(10 mmol/L)
High Limit range:e
40–400 mg/dL (2.2–
22.2 mmol/L)
Your Low Glucose Limit must be at least 10 mg/dL (0.6 mmol/L) below your High Glucose Limit. For example, if your High
Glucose limit is 200 mg/dL (11.1 mmol/L), then your Low Glucose limit cannot be higher than 190 mg/dL (10.5 mmol/L).
194
b.
Your High Glucose Limit must be at least 10 mg/dL (0.6 mmol/L) above your Low Glucose Limit.
c.
If you select this option the sensor glucose graphs will show continuously on the pump screen.
d.
The AUC Low Limit can be equal to, but not higher than the AUC High Limit.
e.
The AUC High Limit can be equal to, but not lower than the AUC Low Limit.
Pump specifications
Guidance and manufacturer's declaration
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The Paradigm 523/723/523K/723K pump system (consisting of the MMT-523/723/523K/723K pump and
MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below. The
customer or the user of the Paradigm 523/723/523K/723K pump system should make sure that it is
used in such an environment.
Emissions Test
RF emissions
Compliance
Group 1
The Paradigm 523/723/523K/723K pump system
uses RF energy only for system communication
functions. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
Class B
The Paradigm 523/723/523K/723K pump system is
suitable for use in all establishments other than
domestic and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
Not applicable
NOTE:
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Electromagnetic Environment - Guidance
Not applicable
The preceding statement is required by
IEC 60601-1-2 for Group 1, Class B devices.
However, since the Paradigm 523/723/523K/723K
pump system is battery powered, its emissions will
not be affected by the establishment power supply
and there is no evidence of any issues associated
with the use of the system in domestic
establishments.
Chapter 14
Pump specifications
195
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Paradigm 523/723/523K/723K pump system (consisting of the MMT-523/723/523K/723K pump and
MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below. The
customer or the user of the Paradigm 523/723/523K/723K pump system should make sure that it is
used in such an environment.
Immunity Test
Electrostatic discharge
(ESD)
IEC 60601 Test Level
±6 kV contact
±8 kV air
IEC 61000-4-2
Electromagnetic Environment
- Guidance
±30 kV air
(<5% relative
humidity)
The Paradigm
523/723/523K/723K pump
system should not be affected
by electrostatic discharge that
might occur under normal
conditions of use.
Electrical fast transient/
burst
±2 kV for power supply
lines
Not applicable
Not applicable
IEC 61000-4-4
±1 kV for input/output
lines
Not applicable
Not applicable
Surge
±1 kV line(s) to line(s)
Not applicable
Not applicable
IEC 61000-4-5
±2 kV line(s) to earth
Not applicable
Not applicable
Voltage dips, short
interruptions and voltage
variations on power
supply lines
<5% UT (>95% dip in UT)
for 0.5 cycle
Not applicable
Not applicable
40% UT (60% dip in UT)
for 5 cycles
Not applicable
Not applicable
70% UT (30% dip in UT)
for 25 cycles
Not applicable
Not applicable
<5% UT (>95% dip in UT)
for 5 seconds
Not applicable
Not applicable
IEC 61000-4-11
196
Compliance
Level
Pump specifications
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Paradigm 523/723/523K/723K pump system (consisting of the MMT-523/723/523K/723K pump and
MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below. The
customer or the user of the Paradigm 523/723/523K/723K pump system should make sure that it is
used in such an environment.
Immunity Test
Power frequency
(50/60 Hz) magnetic field
IEC 60601 Test Level
3 A/m
Compliance
Level
3 A/m
IEC 61000-4-8
NOTE:
Electromagnetic Environment
- Guidance
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Paradigm 523/723/523K/723K pump is intended for use in the electromagnetic environment
specified below. The customer or user of the Paradigm 523/723/523K/723K pump system should make
sure that it is used in such an environment.
Immunity
Test
IEC 60601
Level
Compliance
Level
Electromagnetic Environment Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Paradigm
523/723/523K/723K pump, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
10 Vrms
150 kHz to
80 MHz
Not applicable
Chapter 14
Conducted RF
IEC 61000-4-6
Not applicable
Pump specifications
197
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Paradigm 523/723/523K/723K pump is intended for use in the electromagnetic environment
specified below. The customer or user of the Paradigm 523/723/523K/723K pump system should make
sure that it is used in such an environment.
Immunity
Test
Radiated RF
IEC 61000-4-3
IEC 60601
Level
10 V/m
80 MHz to
6.0 GHz
Compliance
Level
10 V/m
Electromagnetic Environment Guidance
d = 0.35 P
80 MHz to 800 MHz
d = 0.70 P
800 MHz to 6.0 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
198
Pump specifications
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Paradigm 523/723/523K/723K pump is intended for use in the electromagnetic environment
specified below. The customer or user of the Paradigm 523/723/523K/723K pump system should make
sure that it is used in such an environment.
Immunity
Test
NOTE:
IEC 60601
Level
Compliance
Level
Electromagnetic Environment Guidance
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption, and reflection from structures, objects and people.
aField
strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be predicted
theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Paradigm 523/723/523K/723K pump is used exceeds the applicable RF compliance level above, the
Paradigm 523/723/523K/723K pump should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Paradigm 523/723/523K/723K pump.
bOver
the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Chapter 14
Pump specifications
199
Recommended separation distances between portable and mobile RF communications
equipment and the Paradigm 523/723/523K/723K pump system
This section provides information on the recommended separation distance between portable and
mobile RF communications equipment and the Paradigm 523/723/523K/723K pump. The Paradigm
523/723/523K/723K pump is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. Paradigm 523/723/523K/723K pump users can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Paradigm 523/723/523K/723K pump as
recommended below, according to the maximum output power of the communications equipment.
Separation distance according to the frequency of transmitter (m)
Rated maximum
output power of
transmitter (W)
80MHz to 800MHz
0.01
0.035
0.07
0.1
0.11
0.11
1
0.35
0.7
10
1.1
2.2
100
3.5
7
d = 0.35 P
800MHz to 6.0GHz
d = 0.70 P
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where
p is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE:
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
200
Pump specifications
Icon table
Follow instructions for use
Attention: Read all warnings and precautions in instructions for use.
Manufacturer
Date of manufacture (year - month)
Batch code
Use by (year - month)
Catalogue number
Device serial number
Storage temperature range
Magnetic Resonance (MR) unsafe
Fragile product
Type BF equipment (Protection from electrical shock)
Conforms to IEC60601-1 sub-clause 44.6 and IEC60529 standard
Recycle
Chapter 14
Radio communication device
Pump specifications
201
202
Pump specifications
Sensor accuracy
You should review the information in this section with your healthcare professional.
The Medtronic MiniMed Paradigm 523/723/523K/723K pumps use a glucose sensor to continuously monitor
your glucose levels. The 523/723/523K/723K pumps use the same algorithm as the Guardian RT®. The
Guardian RT was evaluated in two clinical studies and the following information in this section describes the
findings. The remainder of this section discusses the results of this pivotal study, and uses the term Guardian
RT.
Appendix A
NOTE:
NOTE: The Guardian RT is not an abbreviation for the Guardian REAL-Time CGM System. The Guardian
RT is a continuous glucose monitoring system that was developed before the Guardian REAL-Time CGM
System. The Guardian RT was originally named TGMS II, and later renamed Guardian RT.
The Medtronic Guardian RT uses a glucose sensor to continuously monitor your glucose levels. The Guardian
RT sensor is calibrated using your home blood glucose meter. Once calibrated, the Guardian RT records
glucose values every five minutes. These values were compared to reference laboratory blood glucose
measurements to check the Guardian RT’s performance characteristics in two clinical studies.1, 2
Although presentations to characterize performance of the Guardian RT are given below, there is no
commonly accepted statistical approach for capturing the performance of continuous glucose monitors such
as the Guardian RT. Performance may be best characterized by viewing graphs called time-elapsed plots. In
these plots, the values from Guardian RT for one subject over time are overlaid with values at the same time
from the glucose reference method. Three representative time-elapsed plots are shown at the end of this
section of sensors that exhibited excellent performance, average performance and poor performance.
1. Medtronic Diabetes, A Frequent Sample Accuracy Evaluation of the Medtronic Diabetes Telemetered Glucose Monitoring System
II (TGMS II) in Subjects with Type 1 Diabetes Mellitus, August 2004.
2. Medtronic Diabetes, An Accuracy Evaluation of the Medtronic Diabetes Guardian RT Glucose Monitoring System in Pediatric
Subjects with Type 1 Diabetes Mellitus, February, 2006.
Sensor accuracy
203
Performance results in adults
The performance of the Guardian RT in adults was evaluated in a clinical study. Guardian RT results were
compared to plasma glucose values from a reference method, the YSI 2300 STAT Plus™ glucose analyzer
(referred to as YSI). Sixteen subjects with Type I diabetes participated in a single-site in-clinic study. Subjects
ranged in age from 18 to 65 years old. Each subject wore two Guardian RT systems simultaneously. One
Guardian system was calibrated an average of 3.5 times per day, and the other was calibrated approximately
five times per day using the Paradigm Link blood glucose meter. YSI measurements were taken every thirty
(30) minutes.
Users and their healthcare professionals should consider that performance in this study may be idealized,
and that performance may be worse when the Guardian RT is used in a less controlled home setting. For
example:
•
•
•
•
204
The mean Hemoglobin A1c among the 16 participants was 8.2 percent. As hemoglobin A1c levels rise,
conditions often occur which are most challenging to test systems measuring glucose in interstitial fluid,
i.e., higher glucose levels, more rapid changes in glucose concentrations, and often more hypoglycemic
episodes.
Subjects saw, on average, between 4 and 5 fingerstick values per day. This enables subjects to better
manage their diabetes when compared to those who perform less fingersticks per day. Agreement
between Guardian RT and YSI values is shown to be closer at mid-range glucose levels, as compared to
agreement at low or high glucose concentrations.
Subjects were more limited in their activities than what may exist in home use, and they were provided
with all their meals. Sensors were also inserted by clinic staff rather than the subjects themselves.
Subjects who are more active, or with poor eating habits, may create more challenging conditions for
the Guardian RT.
Performance of the Guardian RT may vary depending on the glucose meter used and how well the meter
is maintained. It is important to carry out quality-control checks on the meter and code the meter
according to the manufacturer's instructions to optimize performance of the Guardian RT.
Appendix A
Accuracy of Guardian RT readings
In this study, YSI measurements (taken every half hour) were paired with the corresponding Guardian RT
reading (taken every five minutes). Pairing was done by selecting the Guardian RT value closest in time to
the YSI test result. Agreement was analyzed by comparing paired glucose measurements.
Number of Paired Glucose Measurements
3941
Mean Absolute Percent Difference (± SD)
19.7 ± 18.4%
Bias
Appendix A
Agreement between the matched pair was estimated by evaluating the difference between the Guardian RT
reading and the YSI measurement. The difference between them was calculated as a percentage of the YSI
(Mean Absolute Percent Difference). The bias was also calculated, and it is defined as the overall difference
between the Guardian RT glucose values and the YSI values. The paired glucose measurements are
summarized below.
-0.8 mmol/L (-15.0 mg/dL)
The accuracy of the Guardian RT was also evaluated by calculating the percentage of Guardian RT readings
within 20 percent and within 30 percent of the YSI reading (or within 1.1 mmol/L (20 mg/dL) in the low
glucose range). Results are shown below.
Plasma Glucose
Range (mg/dl)
Plasma Glucose
Range (mmol/l)
Overall
a.
Number of Paired
Readings
Percent Within
20%
Percent Within
30%
3941
62%
79%
40-80a
2.2-4.4
356
68%
68%
>80-120
>4.4-6.7
769
60%
77%
>120-240
>6.7-13.3
2362
62%
81%
>240
>13.3
454
61%
82%
For the Low glucose range, 2.2-4.4 mmol/L (40-80 mg/dL), the value shown is the percent within
1.1 mmol/L (20 mg/dL).
Sensor accuracy
205
The Clarke Error Grid was used to assess the clinical relevance of the differences between the Guardian RT
readings and the comparative YSI measurements. The Clarke Error Grid divides a correlation plot into 5 zones.
See following table.
Results in zones A and B are considered clinically acceptable, while results in zones C, D, and E are potentially
dangerous and, therefore, clinically significant errors. The Clarke Error Grid zones are labeled on the
correlation plot.
Zone
206
Description
A
Clinically accurate, would lead to correct treatment decisions
B
Would lead to benign decisions or no treatment
C
Would lead to over-correction of normal glucose levels
D
Would lead to failure to detect and treat high or low glucose levels
E
Would lead to erroneous treatment decisions
Appendix A
The plot below is a correlation plot of Guardian RT readings versus readings from the reference method, the
YSI 2300 Glucose Analyzer. It is overlaid with the Clarke Error Grid.
The total number of paired data points is 3941.
Sensor BG (mg/dL)
Appendix A
400
Meter BG (mg/dL)
Sensor accuracy
207
The percent of Guardian RT readings in the previous graph are presented in the following table according to
the percentage of points falling within each zone (A-E). Results are further broken down (stratified) according
to the range of glucose concentrations.
Glucose
Range
(mg/dl)
A+B
A
B
C
D
E
40-80
356 (9)
271 (76.1)
214 (60.1)
57 (16.0)
2 (0.6)
80 (22.5)
3 (0.8)
81-120
769 (20)
768 (99.9)
463 (60.2)
305 (39.7)
1 (0.1)
N/Aa
N/A
121-240
2362 (60)
2352 (99.6)
1476 (62.5)
876 (37.1)
4 (0.2)
N/A
6 (0.2)
>240
454 (11)
394 (86.8)
277 (61.0)
117 (25.8)
N/A
59 (13.0)
1 (0.2)
Overall
3941 (100)
3785 (96.0)
2430 (61.7)
1355 (34.4)
7 (0.2)
139 (3.5)
10 (0.2)
a.
208
Number and
(%) of Data
Points
Evaluated
N/A means that the Clarke Error Grid does not consider the possibility of these zones in that concentration range.
Appendix A
Precision of Guardian RT readings
Glucose Conc (mg/dL)
Appendix A
This study was also designed to look at the reproducibility of two sensors worn simultaneously at different
locations on the body. Precision was estimated by comparing the glucose readings from the two Guardian RT
systems. In this study 11,475 paired sensor Guardian RT values were obtained. On average, they were
different by 17.2 percent. The following figure is an example of how data was paired in this study. In the
graph there are two tracings of Guardian RT values. Each tracing comes from a different Guardian RT unit
worn by one subject during a one-day period.
Time of day
The above chart, Guardian RT device #2 is represented by a solid line, and the Guardian RT device #4 by a
light-gray line.
Sensor accuracy
209
Low and High alerts in adults
The ability of the Guardian RT to detect high and low glucose levels was measured in the same clinical study.
Since it is important to set the alert levels in a conservative fashion, the Low Glucose Alert should be set at
a value slightly higher than the value of blood glucose you want to detect, and the High Glucose Alert should
be set at a value slightly lower than the value of blood glucose you want to detect.
NOTE:
Please ask your healthcare professional which low and high alert setting is best for you.
The Low Glucose alert
The Low Glucose Alert was evaluated for its ability to detect glucose levels at 70 mg/dL (3.9 mmol/L), or
below, using the YSI 2300 STAT Plus glucose analyzer. As a reference, with the Low Glucose Alert set at 70
mg/dL (3.8 mmol/L), 49% (100/205) of low glucose events were detected by the Guardian RT. Better
detection of low blood glucose can be obtained by setting the Low Glucose Alert level higher. For example,
setting the Low Glucose Alert at 90 mg/dL (5.0 mmol/L), instead of 70 mg/dL (3.9 mmol/L), increases the
ability to detect low blood glucose levels from 49% to 82% (see the following table).
Sometimes the Guardian RT will alert when the blood glucose levels are not low. When the Guardian RT Low
Alert was set at 70 mg/dL (3.9 mmol/L) in this study, 43% of the results were considered false alerts (actual
blood glucose values are greater than 85 mg/dL (4.7 mmol/L)). This percentage may be exaggerated because
blood glucose may be dropping when the Guardian RT alerts. The table below shows the percent of Low
Glucose readings correctly identified by the Guardian RT for specific settings.
Guardian RT Low Alert
Setting (mg/dL)
True Alert Ratea
False Alert Rateb
70
3.9
49%
60%
80
4.4
68%
64%
90
5.0
82%
75%
100
5.6
90%
79%
a.
True Alert Rates are the % of times when the glucose level was at or below the alert setting and the alert sounded.
b.
False Alerts Rates are the % of times when the Guardian RT Sensor alarmed but the blood glucose level was greater than
the alert setting.
210
Guardian RT Low Alert
Setting (mmol/L)
Appendix A
Increasing the Low Alert settings will improve the ability to detect low blood glucose events, but it will also
increase the frequency of Guardian RT false alerts for blood glucose levels not below the target value. You
should consider this trade-off between the improved ability to detect true low blood glucose versus the
increased number of false alerts when setting the low alert threshold.
The High Glucose Alert was evaluated for its ability to detect glucose levels at 250 mg/dL (13.8 mmol/L), or
above, using the YSI analyzer. As a reference, with the High Glucose Alert set at 250 mg/dL (13.8 mmol/L),
53% (195/365) of high glucose events were detected by the Guardian RT. Better detection of high blood
glucose can be obtained by setting the High Glucose Alert level lower. For example, setting the High Glucose
Alert at 190 mg/dL (10.6 mmol/L), instead of 250 mg/dL (13.8 mmol/L), increases the ability to detect high
blood glucose levels from 53% to 85% (see the following table).
Appendix A
The High Glucose alert
Sometimes the Guardian RT will alert when the blood glucose levels are not high. When the Guardian RT High
Alert was set at 250 mg/dL (13.8 mmol/L) in this study, 7.2% of the results were considered false alerts
(actual blood glucose values are less than 225 mg/dL (12.5 mmol/L)). This percentage may be exaggerated
because blood glucose may be rising when the Guardian RT alerts. The table below shows the percent of High
Glucose readings correctly identified by the Guardian RT for specific settings.
Guardian RT High Alert
Setting (mg/dL)
Guardian RT High Alert
Setting (mmol/L)
True Alert Ratea
False Alert Rateb
190
10.6
85%
64%
200
11.1
81%
58%
225
12.5
67%
40%
250
13.8
53%
25%
a.
True Alert Rates are the % of times when the glucose level was at or above the alert setting and the alert sounded.
b.
False Alerts Rates are the % of times when the Guardian RT Sensor alarmed but the blood glucose level was lower than
the alert setting.
Decreasing the High Alert settings will improve the ability to detect high blood glucose events, but it will
also increase the frequency of Guardian RT false alerts for blood glucose levels not above the target value.
You should consider this trade-off between the improved ability to detect true high blood glucose versus the
increased number of false alerts when setting the high alert threshold.
Sensor accuracy
211
Guardian RT sensor performance and calibration stability as a function of
time
The Guardian RT sensor may be worn for up to 3 days (72 hours) and must be calibrated at least twice a day.
Two sets of data, approximately equal in number, were collected during the clinical trial. One data set was
generated when the frequency of calibrations averaged 3.5 per day (Data Set A), and the other averaged 5
times a day (Data Set B). During the study, a total of 38 sensors were evaluated in 16 individuals.
As per the stratified Clarke Error Grid analysis above, agreement between Guardian RT values and YSI values
tends to be less at low and high glucose concentrations when compared to other concentration ranges.
Guardian RT performance in the hypoglycemic range, as a function of sensor insertion time, is characterized
below. Results from the two different data sets are presented. The two populations were separated according
to the number of calibrations per day. This table represents the percentage of Data Points in the 2.2 - 4.4
mmol/L (40-80 mg/dL) range that fell within 1.1 mmol/L (20 mg/dL). Data is presented in 12-hour
increments.
212
Data Set
0-12 hrs
12-24 hrs
24-36 hrs
36-48 hrs
48-60 hrs
60-72 hrs
A
78%
81%
73%
65%
56%
41%
B
67%
70%
93%
60%
75%
38%
Appendix A
An analysis of the mean percentage of Absolute Relative Error (ARE percentage) and standard deviations,
across 12-hour increments of wear periods, appears in the table below. Both data sets are pooled together
in this data.
Mean ARE (%)
Std. Dev.
0-12 hrs
24.84
20.04
12-24 hrs
19.66
16.17
24-36 hrs
16.43
15.62
36-48 hrs
18.23
19.27
48-60 hrs
16.59
14.25
>60 hrs
22.95
23.51
Appendix A
Hours From Insertion
The median sensor life from Data Sets A and B were 57.5 hours and 72.9 hours, respectively. Twenty-one of
the sensors operated for 72 hours, while the others were removed for a variety of reasons, most often because
of calibration errors.
Sensor accuracy
213
The percentage of Guardian RT readings within 20 percent and 30 percent of YSI readings was analyzed
according to time after sensor insertion and according to the glucose-concentration range (as determined by
the YSI analyzer). See the following table.
a.
Percentage of Guardian RT values
within 20% of YSI laboratory readings
Percentage of Guardian RT values
within 30% of YSI laboratory readings
Glucose Range
(mg/dl)
During first 60
hours of sensor
wear
After 60 hours of
sensor wear
During first 60
hours of sensor
wear
After 60 hours of
sensor wear
40-80a
62-82%
39%
62-82%
39%
81-120
57-66%
48%
72-84%
66%
Agreement to within ± 1.1 mmol/L (20 mg/dL) for glucose readings ≤ 4.4 mmol/L (80 mg/dL)
Performance of the Guardian RT was evaluated according to the length of time since calibration. This data
is not conclusive because of the limited number of data points during the final 3 hours of the 12-hour
calibration cycle, i.e., 10. In contrast, 3-hour time bins, earlier in the 12-hour cycle, contained hundreds of
data points. This may suggest that calibrations are often required prior to the 12-hour calibration cycle.
214
Appendix A
Effects of calibration frequency
•
•
Specificity increased 2-4 percent in the hypoglycemic range and decreased 0-2 percent in the
hyperglycemic range
Sensitivity increased between 5-9 percent across the hyperglycemic range, and decreased 7-16 percent
when the alarm was set to 80 mg/dl or below, and decreased 3-7 percent when set between 85 and 100
mg/dl
Appendix A
The average bias when Guardian RT was calibrated ~ 3.5 times a day was -20.5 ± 41 mg/dl (LL: -22.40 mg/dl
and UL: -18.63 mg/dl). In those calibrated ~ 5 times a day, the bias was -10.2 mg/dl ± 36 mg/dl (LL: -11.74
mg/dl and UL: -8.66 mg/dl). When comparing Guardian RT units that were calibrated less often to those
calibrated more often, the following alarm performance was observed:
Stratified error grid analysis also shows better performance in the hypoglycemic range when fewer
calibrations are performed, i.e., 62 percent of data points are in Zone A when fewer calibrations were
performed, whereas 58 percent were in Zone A when more calibrations were performed.
Sensor accuracy
215
Time-elapsed plots
Glucose Conc (mg/dL)
The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucose
reading, where sensor showed excellent performance. The open circles (o) on the graph represent the meter
calibration readings. The closed circles (•) represent the reference blood glucose readings, and the solid line
(—) represents the sensor glucose value.
Day 1
216
Appendix A
Day 2
Day 3
Day 4
The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucose
reading, where sensor showed average (typical) performance. The open circles (o) on the graph represent
the meter calibration readings. The closed circles (•) represent the reference blood glucose readings, and
the solid line (—) represents the sensor glucose value.
Glucose Conc (mg/dL)
Appendix A
Day 1
Day 2
Day 3
Day 4
Sensor accuracy
217
Glucose Conc (mg/dL)
The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucose
reading, where sensor showed poor performance. The open circles (o) on the graph represent the meter
calibration readings. The closed circles (•) represent the reference blood glucose readings, and the solid line
(—) represents the sensor glucose value.
Day 1
218
Appendix A
Day 2
Day 3
Day 4
Performance results in children and adolescents
Accuracy of Guardian RT readings
In this study, each blood glucose meter measurement was paired with the corresponding Guardian RT reading
(taken every 5 minutes). Pairing was done by selecting the Guardian RT value closest in time to the blood
glucose meter result. Agreement was analyzed by comparing paired glucose measurements.
Appendix A
The performance of the Guardian RT in Children and Adolescents was evaluated in a clinical study. Guardian
RT results were compared to capillary blood glucose measured by a OneTouch® Ultra® Meter. Sixty subjects
with Type I diabetes participated in a three-site out-patient study. Subjects ranged in age from 7 to 17 years
old. Each subject wore a Guardian RT system, which records a sensor glucose value every five minutes.
Subjects were instructed to perform at least seven blood glucose meter measurements each day.
Agreement between the matched pair was estimated by evaluating the difference between the Guardian RT
reading and the blood glucose meter measurement. The difference between them was calculated as a
percentage of the blood glucose meter measurement (Mean Absolute Percent Difference). The bias was also
calculated, and it is defined as the overall difference between the Guardian RT glucose values and the blood
glucose meter values. The paired glucose measurements are summarized in the following table
Number of Paired Glucose Measurements
2599
Mean Absolute Percent Difference (± SD)
19.0 ± 19.7%
Bias
-6.0 mg/dL (-0.3 mmol/L)
Sensor accuracy
219
The accuracy of the Guardian RT was also evaluated by calculating the percentage of Guardian RT readings
within 20% and within 30% of the blood glucose meter reading (or within 20 mg/dL (1.1 mmol/L) in the low
glucose range). Results are shown in the following table.
Plasma Glucose
Range (mg/dL)
Plasma Glucose
Range (mmol/L)
Overall
a.
Number of Paired
Readings
Percent Within
20%
Percent Within
30%
2599
68%
82%
40-80a
2.2-4.4
360
51%
----
> 80-120
> 4.4-6.7
482
60%
77%
> 120-240
> 6.7-13.3
1055
74%
90%
> 240
> 13.3
702
75%
89%
For the Low glucose range, 40-80 mg/dL (2.2-4.4 mmol/L), the value shown is the percent within 20 mg/dL (1.1 mmol/L).
The Clarke Error Grid was used to assess the clinical relevance of the differences between the Guardian RT
readings and the comparative blood glucose meter measurements. The Clarke Error Grid divides a correlation
plot into 5 zones. See the following table.
Results in zones A and B are considered clinically acceptable, while results in zones C, D, and E are potentially
dangerous and, therefore, clinically significant errors. The Clarke Error Grid zones are labeled on the
correlation plot.
Zone
220
Description
A
Clinically accurate, would lead to correct treatment decisions
B
Would lead to benign decisions or no treatment
C
Would lead to over-correction of normal glucose levels
D
Would lead to failure to detect and treat high or low glucose levels
E
Would lead to erroneous treatment decisions
Appendix A
The following figure is a correlation plot of Guardian RT readings versus readings from the reference method,
the blood glucose meter. It is overlaid with the Clarke Error Grid. The total number of paired data points is
2599.
Sensor BG (mg/dL)
Appendix A
A (1733, 66.7%)
B (665, 25.6%)
C (7, 0.3%)
D (193, 7.4%)
E (1, 0.0%)
Meter BG (mg/dL)
The percent of Guardian RT readings in the above graph are presented in the table below according to the
percentage of points falling within each zone (A-E). Results are further broken down (stratified) according
to the range of glucose concentrations.
Sensor accuracy
221
Stratified Clarke Error Grid Analysis
Range of
Comparative
Glucose
Readings
(mg/dL)
222
Total
Count
A+B
A
B
C
D
E
40-80
360 (13.9%)
201
(55.8%)
141
(39.2%)
60 (16.7%)
1 (0.3%)
157
(43.6%)
1 (0.3%)
81-120
482 (18.5%)
478
(99.2%)
287
(59.5%)
191
(39.6%)
4 (0.8%)
0 (0%)
0 (0%)
121-240
1055
(40.6%)
1053
(99.8%)
782
(74.1%)
271
(25.7%)
2 (0.2%)
0 (0%)
0 (0%)
240-400
702 (27.0%)
666
(94.9%)
523
(74.5%)
143
(20.4%)
0 (0%)
36 (5.1%)
0 (0%)
Overall
2599
(100.0%)
2398
(92.3%)
1733
(66.7%)
665
(25.6%)
7 (0.3%)
193 (7.4%)
1 (0.0%)
Appendix A
Low and High alerts in children and adolescents
NOTE:
Please ask your healthcare professional which low and high alert setting is best for you.
The Low Glucose alert
Appendix A
The ability of the Guardian RT to detect high and low glucose levels was measured in the same clinical study.
Since it is important to set the alert levels in a conservative fashion, the Low Glucose Alert should be set at
a value slightly higher than the value of blood glucose you want to detect, and the High Glucose Alert should
be set at a value slightly lower than the value of blood glucose you want to detect.
The Low Glucose Alert was evaluated for its ability to detect glucose levels at 70 mg/dL (3.9 mmol/L), or
below, using the blood glucose meter. As a reference, with the Low Glucose Alert set at 70 mg/dL (3.8
mmol/L), 24% (59/244) of low glucose events were detected by the Guardian RT. Better detection of low
blood glucose can be obtained by setting the Low Glucose Alert level higher. For example, setting the Low
Glucose Alert at 90 mg/dL (5.0 mmol/L), instead of 70 mg/dL (3.9 mmol/L), increases the ability to detect
low blood glucose levels from 24% to 70% (see the following table).
Sometimes the Guardian RT will alert when the blood glucose levels are not low. When the Guardian RT Low
Alert was set at 70 mg/dL (3.9 mmol/L) in this study, 48% of the results were considered false alerts (actual
blood glucose values are greater than 85 mg/dL (4.7 mmol/L)). This percentage may be exaggerated because
blood glucose may be dropping when the Guardian RT alerts.
The table below shows the percent of Low Glucose readings correctly identified by the Guardian RT for
specific settings.
Guardian RT Low Alert
Setting (mg/dL)
Guardian RT Low Alert
Setting (mmol/L)
True Alert Ratea
False Alert Rateb
70
3.9
24%
48%
80
4.4
52%
46%
90
5.0
70%
52%
100
5.6
85%
57%
a.
True Alert Rates are the % of times when the glucose level was at or below the alert setting and the alert sounded.
b.
False Alerts Rates are the % of times when the Guardian RT Sensor alarmed but the blood glucose level was greater than
the alert setting.
Sensor accuracy
223
Increasing the Low Alert settings will improve the ability to detect low blood glucose events, but it will also
increase the frequency of Guardian RT false alerts for blood glucose levels not below the target value. You
should consider this trade-off between the improved ability to detect true low blood glucose versus the
increased number of false alerts when setting the low alert threshold.
The High Glucose alert
The High Glucose Alert was evaluated for its ability to detect glucose levels at 250 mg/dL (13.8 mmol/L), or
above, using the blood glucose meter. As a reference, with the High Glucose Alert set at 250 mg/dL (13.8
mmol/L), 64% (404/632) of high glucose events were detected by the Guardian RT. Better detection of high
blood glucose can be obtained by setting the High Glucose Alert level lower. For example, setting the High
Glucose Alert at 190 mg/dL (10.6 mmol/L), instead of 250 mg/dL (13.8 mmol/L), increases the ability to
detect high blood glucose levels from 64% to 94% (see the following table).
Sometimes the Guardian RT will alert when the blood glucose levels are not high. When the Guardian RT High
Alert was set at 250 mg/dL (13.8 mmol/L) in this study, 13.1% of the results were considered false alerts
(actual blood glucose values are less than 225 mg/dL (12.5 mmol/L)). This percentage may be exaggerated
because blood glucose may be rising when the Guardian RT alerts. The following table shows the percent of
High Glucose readings correctly identified by the Guardian RT for specific settings.
Guardian RT High Alert
Setting (mg/dL)
Guardian RT High Alert
Setting (mmol/L)
True Alert Ratea
False Alert Rateb
190
10.6
94%
40%
200
11.1
91%
36%
225
12.5
81%
21%
250
13.8
64%
13%
a.
True Alert Rates are the % of times when the glucose level was at or above the alert setting and the alert sounded.
b.
False Alerts Rates are the % of times when the Guardian RT Sensor alarmed but the blood glucose level was lower than
the alert setting.
Decreasing the High Alert settings will improve the ability to detect high blood glucose events, but it will
also increase the frequency of Guardian RT false alerts for blood glucose levels not above the target value.
You should consider this trade-off between the improved ability to detect true high blood glucose versus the
increased number of false alerts when setting the high alert threshold.
224
Appendix A
Glossary
A1C (HbA1c) test - A 2-3 month
average of blood glucose
values expressed in percent.
The normal range varies with
different labs and is expressed
in percent (such as 4 - 6%).
Accept - Pressing the ACT button
to approve the selection or
setting.
Active insulin - Bolus insulin that
has been delivered to your
body, but has not yet been
used.
Adverse reaction - An
unexpected, unpleasant or
dangerous reaction to a sensor
when it is inserted into the
body. An adverse reaction may
be sudden or may develop over
time.
Alarm - Audible or vibrating
(silent) notice that indicates
the pump is in Attention mode
and immediate attention is
required. Alarms are prefixed
in the alarm history with the
letter A.
Alarm clock - Feature you can set
to go off at specified times of
the day.
ALARM HISTORY - Screen that
displays the last 36 alarms/
errors that have occurred on
your pump.
Alarm icon - a solid circle that
shows at the top of the screen
and the pump beeps or
vibrates periodically until the
condition is cleared (see
Attention mode).
Alert - Audible or vibrating
(silent) indicator that notifies
you the pump needs attention
soon or that you should be
reminded of something. Insulin
delivery continues as
programmed.
exists that requires immediate
attention.
AUC Limits - The AUC Limits
feature allows you to see how
long your sensor glucose
measurements are outside
your target range. Your target
range is the area between your
Low AUC Limit and your High
AUC Limit. When you set the
AUC Limits, you select the Low
AUC Limit and High AUC Limit
you want for your target range.
Glossary
A
B
Alert icon - an open circle that
appears at the top of the
screen and the pump beeps or
vibrates periodically to remind
you of the condition (see
Special mode).
Backlight - Pump screen light.
Turns on whenever the
button is pressed or in
combination with the
button if not on the HOME
screen. The backlight also
appears during alarms and
alerts, except for LOW
BATTERY alert and OFF NO
POWER alarm.
Attention mode - Operating
mode that stops all current
insulin delivery. This mode
indicates an alarm or condition
Basal patterns - The user can
program up to three different
basal rate patterns into the
pump for the delivery of basal
Glossary
225
insulin: Standard, A, and B. For
each pattern, there is an
option of setting up to 48 basal
rates.
Basal rate - The pump setting that
provides a continuous infusion
of insulin to keep the blood
glucose stable between meals
and during the night. Basal
insulin mimics pancreatic
insulin delivery—which meets
all the body's non-food related
insulin needs.
BASAL REVIEW screen - shows
the basal rates programmed in
the pump, with the 24-hour
total for each rate.
BG - Blood Glucose
BG Reminder - Feature that you
can set to remind you to check
your blood glucose after a
bolus.
BG Target - Normal blood glucose
level
BG Units - Blood glucose units
used by the pump (mg/dL or
mmol/L).
Block - Feature that restricts
access to all programming
except suspend, selftest and
the delivery of a bolus with the
remote control.
Blood glucose (BG) - A form of
digested sugar in the
bloodstream. Glucose is the
major source of energy for
living cells, and is carried to
each cell through the blood
stream. Cells cannot use
226
Glossary
glucose without the help of
insulin.
Bolus - A dose of insulin given to
cover an expected rise in blood
glucose (such as the rise after
a meal) or to lower a high
blood glucose down to target
range.
BOLUS HISTORY - This screen
displays the last 24 boluses
delivered by your pump.
Bolus Wizard® feature Calculates the bolus amount
based on personal information
of the pump user.
C
Cal Reminder - The value of the
Cal Reminder is the amount of
time before the current
calibration value expires when
the user wants to be reminded
to calibrate by having the
pump issue a METER BG BY
alert. For example, if the Cal
Reminder is set to two hours,
the METER BG BY alert will
occur two hours before the
calibration is required.
Cal Repeat - Once a METER BG
NOW alert occurs, the pump
will not repeat the alert until
after this selected Cal Repeat
time.
Calibrate - Check, adjust, or set
to a standard (calibrate your
pump).
Cannula - A short, thin, and
flexible tubing at the end of
the infusion set that is inserted
into the subcutaneous tissue to
deliver insulin.
Carb ratio (Carbohydrate ratio) Used when counting
carbohydrates in grams. The
amount of carbohydrates
covered by one unit of insulin.
(Also see exch ratio.)
Carb units - The food entry when
using the Bolus Wizard feature.
Entered as (carbohydrate)
grams or exchanges.
Carbohydrate - One of the three
main sources of energy or
calories in food.
Carbohydrates are mainly
sugars found in fruits, milk,
and starches that the body
breaks down into glucose.
CH - Carbohydrate
Contraindication - A condition
that makes a specific
treatment or procedure NOT
advisable. A contraindication
is literally contra- (against) an
indication, against something
that is indicated as advisable
or necessary.
Correction bolus - The amount of
insulin needed to return a high
blood glucose level back down
to target range.
D
Daily totals - Shows the total
insulin delivered (basal and
bolus) in the last 24-hours.
Maximum records: 32 days
Default - A setting or value for
your pump that is assigned
automatically by your system.
Some default settings cannot
be changed; other default
settings remain in effect until
you change them.
DKA - Diabetic Ketoacidosis
Wave®
bolus - Combination
Dual
of a Normal bolus that is
delivered immediately, then
followed by a Square Wave
bolus. The Square Wave
portion is delivered evenly
over a period of time.
Duration - Amount of time it
takes to administer a bolus or
basal delivery. Also, length of
time for an action or condition.
E
Easy bolus™ - Method of delivery
for a Normal bolus using the
.
Easy Bolus button
Electromagnetic compatibility The condition that exists when
Electrostatic discharge - The
rapid, spontaneous transfer of
electrostatic charge induced
by a high electrostatic field.
The charge usually flows
through a spark, known as
static discharge, between two
objects at different
electrostatic levels as they
approach each other (for
example, when people touch
each other after dragging their
feet on a carpet).
Exch ratio - (Exchange ratio)
Used when counting
carbohydrates as exchanges.
The amount of insulin required
to cover one (1) carbohydrate
exchange. (Also see carb
ratio.)
Express bolus - Method of
delivery for any bolus type
using the EXPRESS BOLUS
.
button
F
Fingerstick - One method used to
test blood glucose by taking a
sample of blood for testing
from a finger using a lancet or
automatic finger puncture
device.
Food bolus - A dose of insulin
given to cover the expected
rise in blood glucose that
occurs after eating.
G
Gastroparesis - A condition of the
digestive system that slows
down the emptying of food
from the stomach.
Generate - create a result (your
pump will generate a graph).
Glucagon Emergency Kit - An
injectable form of glucagon
that can be used to treat
severe low blood glucose levels
(hypoglycemia). A Glucagon
Emergency Kit can be obtained
in a pharmacy with a
prescription.
Glossary
Diabetic Ketoacidosis (DKA) - A
serious condition that occurs
when the insulin levels are
low, blood glucose level are
elevated, and the body uses
fat for energy. This process
produces ketones which upset
the body's acid-base balance
leading to a potentially life
threatening situation.
systems and devices that use
electromagnetic energy
operate properly without
causing or suffering accidental
electromagnetic interference
to or from other
electromagnetic devices.
Glucose tablet - A simple sugar in
tablet form, that is taken
orally to treat low blood
glucose (hypoglycemia).
Glucose tablets can be
purchased from the Medtronic
Diabetes online store at
www.medtronicdiabetes.com
as well as drug stores and
pharmacies.
H
HbA1c - Glycosylated hemoglobin
HDL - High-density lipoprotein A
complex of lipids and proteins
in approximately equal
amounts that functions as a
Glossary
227
transporter of cholesterol in
the blood.
High Glucose - The pump displays
an alert if the sensor indicates
that your sensor glucose is at
or above this value. You have
the option to turn this feature
on or off.
High Repeat - For the High
Glucose, High Predictive, and
Rising Rate of Change alerts,
allows the user to set the delay
between the first alert and any
subsequent alerts. This will
allow the user to avoid getting
an alert every five minutes
until the condition is
corrected.
Hold - Press and continue to press
a pump button.
Hypoglycemia - A condition in
which blood glucose values are
low below 3.9 mmol/L (70
mg/dL). Symptoms may
include behavioral changes,
pale complexion, hunger,
sweating, sudden weakness,
headache, confusion,
drowsiness, nonresponsiveness to questions,
and the most serious: seizure,
convulsion or loss of
consciousness.
I
Idle - The pump is at the HOME
screen.
Increment - A small increase or
decrease in a measurement.
228
Glossary
Indication - A condition that
makes a specific medical
treatment or procedure
advisable or necessary.
Infusion set - Flexible tubing with
a reservoir connector and an
infusion site. This tubing
delivers insulin from the pump
to the body.
Infusion site - The end of the
infusion set held to the body
with a tape. It consists of a
cannula and an introducer
needle.
Initialize - To set a starting value
and/or prepare your pump,
transmitter or sensor for use.
Insulin - A hormone that helps the
body use glucose (sugar) for
energy. The beta cells of the
pancreas make the insulin.
Insulin sensitivity - The amount
by which your blood glucose
(BG) level is reduced by one
unit of insulin. (Bolus Wizard
feature data)
Insulin to carbohydrate ratio The amount of insulin required
to cover a given number of
carbohydrates. This ratio helps
you estimate what size bolus
you should take when eating
carbohydrates. Your
healthcare professional will
determine your insulin to
carbohydrate ratio.
Interstitial fluid - The fluid
between the cells in the
human body.
Introducer needle - This needle
allows the insertion of a
cannula or a sensor into the
subcutaneous tissue. It is
removed and discarded after
insertion leaving only the
cannula or the sensor in the
body.
K
Ketone - A chemical created by
the human body when there is
not enough insulin in the
blood.
kPa (kilopascal) - A unit of
measurement for quantifying
force. Used to measure
atmospheric pressure.
Equivalent to 10,000 dynes per
square centimeter.
L
LDL (Low-density lipoprotein) A complex of lipids and
proteins, with greater amounts
of lipid than protein, that
transports cholesterol in the
blood.
Link - To turn on and setup the
meter option that allows the
pump to receive BG readings
from a meter that
communicates with your
pump.
Log - A record of measurements,
alarms or other actions by your
pump.
Low Glucose - The pump displays
an alert if the sensor indicates
that your sensor glucose is at
or below this value. You have
the option to turn this feature
on or off.
Max bolus - The maximum
amount of bolus insulin that
the pump will deliver at one
time. (set by the user)
Meter - An optional blood glucose
meter powered by MWT1
technology. Your pump can be
programmed to receive your
BG readings from this meter.
Meter option - Feature that
allows the pump to receive BG
readings from a meter
powered by MWT1 technology.
Low resv warning Programmable warning that
notifies you with an alert when
either a specified number of
units remain in the reservoir or
a specified amount of time
remains before the reservoir
will be empty.
MWT1 technology - 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.
M
N
Manual bolus - Selectable item
available in the BOLUS MENU
when the Bolus Wizard feature
is active. It is one method of
programming a bolus without
the Bolus Wizard feature. (see
Set bolus)
Marker - A measurement of a
specific event - such as a BG
measurements, exercise, or
the amount of insulin used.
Max basal rate - The maximum
amount of basal insulin that
Normal bolus - An immediate
delivery of a specified unit
amount of insulin.
Normal mode - Regular operating
mode. No special features are
active, no alert or alarm
conditions exist. Insulin
delivery is normal during this
mode.
Now portion - The normal portion
of a Dual Wave bolus. The now
portion delivers immediately
and is then followed by the
Square portion.
O
Occlusive dressing - A bandage
that seals a wound from air or
bacteria.
P
Pattern A/B - Basal pattern that
supports activities that are not
a part of your day-to-day
routine, but are normal in your
lifestyle. Such activities could
be a sport that you do once a
week or a change in your sleep
pattern over the weekend,
extended periods of higher or
lower activity, or menses.
Glossary
Low Repeat - For the Low
Glucose, Low Predictive, and
Falling Rate of Change alerts,
allows you to set the delay
between the first alert and any
subsequent alerts. This will
allow the user to avoid getting
an alert every five minutes
until the condition is
corrected.
the pump will deliver at one
time. (set by the user)
Predictive alerts - These alerts
can be used so that you receive
alarms before the sensor
glucose measurements reach
your glucose limits. This alert
predicts when the sensor
glucose measurements will
reach your glucose limits by
using information about your
glucose limits and recent
sensor glucose measurements.
Press - To push and release a
button.
PSI - Pound-force per square inch.
Pump S/N - Pump S/N is the serial
number of the pump currently
in use.
Glossary
229
R
Rate of Change alerts - These
alerts can be used to set up the
system so that you receive
alerts if the sensor glucose
measurements change too
rapidly for your needs. You can
set the limit for these alerts so
that you receive an alert
whenever the sensor glucose
measurements fall or rise
faster than the limit.
Sensor Age - Sensor age is the
amount of time, in days and
hours, since the sensor was
first inserted.
Sensor features - Optional
continuous glucose monitoring
capabilities.
Reservoir - The syringe that holds
insulin.
Sensor glucose (SG) - Glucose
levels in the fluid under your
skin measured by the sensor.
Reset - To set again, or change
the information (reset your
glucose values).
Sensor icon - An icon on your
pump that tells you whether
the Sensor feature is On or Off.
Resume - Restarts basal delivery
after the pump is suspended.
Set - To enter or establish a value
for your pump (set your BG
Reminder).
Rewind - The pump drive moves
back to its starting position to
prepare the pump for a new
reservoir.
RF - Radio frequency
S
Scroll - Press the up or down
arrow buttons to move through
the screen text.
Select - Pressing the up or down
arrow buttons to highlight a
desired screen item.
Sen-serter - The Sen-serter is
indicated as an aid for
insertion of the Medtronic
Diabetes glucose sensor.
230
Sensitive - Easily irritated
(sensitive skin), or able to
measure very slight
differences (a sensitive
instrument).
Glossary
Set bolus - Selectable item
available in the BOLUS MENU
when the Bolus Wizard feature
is inactive. One method of
programming a bolus without
the Bolus Wizard feature. (See
Manual bolus.)
S/N# - Serial number.
Special mode - Operating mode
that indicates one or more
special functions is active or a
condition exists that requires
attention.
Square Wave® bolus - Immediate
bolus delivered evenly over a
specified time period (30
minutes to 8 hours).
Square Wave portion - (Sq) The
second part of a Dual Wave
bolus. The Square Wave
portion delivers evenly over a
period of time after the NOW
portion delivers.
Stabilize - To make steady or
keep from changing (stabilize
your blood glucose).
Standard pattern - Your normal
basal that supports your usual
day-to-day activity. When the
Patterns feature is off, the
pump uses your standard basal
pattern.
Status - The condition of a part of
your system (battery status,
alarm/alert status).
Status screen - Displays the
current operations of the
pump, including active
functions, the most recent
basal and bolus deliveries,
reservoir information, and
battery condition.
Step - Measurement of insulin
that you set and use for Easy
Bolus and other bolus
deliveries.
Sterile - Free from substances or
germs that could cause
infection.
Sterile gauze - A thin medical
bandage with loose weave that
is free from substances or
germs that could cause
infection.
Submerge - To place under water
or cover completely with
water.
Suspend - Function that stops all
current insulin deliveries. The
basal delivery is paused until
restarted.
T
W
Weak Signal - The pump displays
an alert if it has not received
data from the sensor for an
amount of time that you set.
Temp - Temporary
Glossary
Temp basal - (Tmp basal)
Temporary one-time basal
insulin with a specified amount
and duration. Used to support
insulin needs for special
activities or conditions that
are not part of the normal daily
routine.
Timeout - If you do not enter
information or do something in
a specific length of time, your
pump automatically stops
what it is doing and goes to the
HOME screen.
Transmitter - The device that
sends a signal to your pump
with information from your
sensor.
Transmtr Batt - The status of the
transmitter battery. Possible
values are Good, Low, or Bad.
Transmtr ID - The serial number
of the transmitter currently in
use.
Transmtr Ver - The software
version of the transmitter
currently in use.
Glossary
231
232
Glossary
Index
Numerics
A
accessories 3
activity guard 3
CareLink USB 3
holster 3
leather case 3
meter 3
pump clip 3
remote control 3
sensor 3
transmitter 3
active insulin 70
Active insulin time
setting 71
adverse reactions 7
alarm clock 142
Alarm conditions 164
alarm frequency 175
ALARM HISTORY screen 133
Alarm types
A (alarm) 164
Auto off 165
Batt out limit 165
High Predicted 163
High XXX MG/DL 162
Lost Sensor 160
Low Predicted 162
Low Transmtr 160
Low XX MG/DL 162
Meter BG By 162
Meter BG Now 162
Missed Bolus 160
Rise Rate 163
sensor 159
Sensor End 161
Sensor Error 163
Weak Signal 159
Area Under the Curve 140
areas
inserting infusion set 53
inserting sensor 115
Attention mode 18
AUC calculation 140
AUC Limits 140
default settings 194
entering 140
auto-off 134
Index
3-hour graph 125
6-hour graph 126
12-hour graph 126
24-hour graph 127
Bolus stopped 165
Button error 165
Check settings 155, 165
E (error) 165
Empty reservoir 166
Failed batt test 166
Finish loading 166
Max delivery 167
Max fill reached 166
Motor error 167
No delivery 153, 167
No reservoir 167
Off No power 167
Reset 167
Weak battery 167
Alarms
responding to 164
review 133
alert frequency 175
Alert Silence 129
default settings 194
options 129
Alert Silence alert 159
alert type
Setting your 133
alerts 159
Alert Silence 159
Cal Error 161, 162
Change Sensor 161
Charge Transmtr 161
Fall Rate 163
for alert conditions 159
low reservoir alert 159
B
backlight 17, 225
BASAL MENU 20
basal rate
daily 42
maximum 43
Index
233
patterns 91
programming 41
stop delivery of 44
temp 94
bathing 131
battery, pump 171, 181
install 12
removing 154
short life 154
beep/vibrate, alert type 17
BG, entering 36
BG Reminder 26, 34, 74, 83, 87
BG Targets 69
BG units 68
default settings 193
bleeding 6, 7, 117
Block feature 144
turn on 144
BLOCK OPTION screen 144
blood glucose
checking 119
entering incorrect
number 161
rapid change 161
blood glucose
measurements 36, 111
non-calibration meter,
examples of 36
blood glucose units
default settings 193
setting 104
bolus
basic 25
details 31
history 30
manual 82
maximum limit 33
stop delivery of 44
bolus delivery
Bolus Wizard 73
Easy Bolus 87
234
Index
bolus delivery, methods for
normal
remote control 3
BOLUS MENU 19
bolus types
Dual Wave 81
Normal 26
Square Wave 81
Bolus Wizard
about 61
entering meter BG 119
estimate details 32
HIGH BG warning 65
how it works 64
LOW BG warning 65
MAX BOLUS EXCEEDED
warning 65
maximum delivery 65
on/off 66
review settings 71
settings 61, 62, 63, 64
Active insulin time 64
BG Target range 64
BG units 62
Carb ratios 62
Carb units 62
Insulin sensitivity 63
specifications 184
your BG reading 61
bruising 7
buttons, pump 11, 13
C
Cal Error alert 161, 162
Cal Reminder 162
default settings 193
setting 111
CAL REMINDER screen 111
Cal Repeat
default settings 193
setting 111
CALIBRATE HISTORY 130
calibrating
frequency 119
calibrating sensor 118
frequency 119
calibrating your system
Capture Event feature 35
calibration
successful 130
values 130
when to 119
Calibration history 130
CAPTURE EVENT 20
Capturing Events 35
Carb ratios
exchanges 67
grams 67
carb units 66
CARB UNITS screen 38
CareLink Personal
Software 35, 149
CareLink USB 3
Change Sensor alert 161
Charge Transmtr alert 161
charger 3
transmitter 114
water-tightness 172
CHECK BG message 35
checking
blood glucose 119
choosing insertion site 115
cleaning
Sen-serter® 173
transmitter 172
cleaning the pump 172
Clear settings 148
connecting transmitter to
tester 168
consumables 2
continuous glucose graphs
reading 122
continuous graph display 113
continuous sensor glucose
levels 124
correction bolus 26, 73, 74
correction estimate 120, 184
D
E
Easy bolus 87
cancel 89
deliver 88
step value 88
electromagnetic emissions 195
Electromagnetic
environment 200
electromagnetic immunity 196
emergency kit 1
emissions 195
ENTER BG screen 36
ENTER FOOD screen 38
entering
carbohydrate information 38
exercise information 38
insulin injection
information 37
meter BG 118, 119, 120
alert 119
Bolus Wizard 119
frequency 119
Other markers 39
Entering meter BG
measurements 36
ESC 4
cancels programming 20
Examples of real-time sensor
glucose graphs 125
exercising
precaution 7
EXPRESS BOLUS button 14
F
Fall Rate alert 163
Fall Rate of Change
setting alert frequency 108
FILL TUBING screen 52
filling
cannula 56
reservoir 48
tubing 52
FIND LOST SENSOR 170
food bolus 26, 62, 64, 73, 74
food entry 61, 74
food estimate 184
frequency
alarm 175
alert 175
G
Index
Daily totals 136
DAILY TOTALS screen
Review 135
default settings
Alert Silence 194
AUC Limits 194
BG Units 193
Cal Reminder 193
Cal Repeat 193
Glucose Alerts 191
Glucose Limits 191
Glucose Limits 1 192
Glucose Limits 2 through
8 192
High Glucose Limit 192
High Repeat 192
insulin delivery 189
Low Glucose Limit 192
Low Repeat 192
Predictive Alerts 193
sensor 191
sensor features 191
sensor glucose graph
timeout 193
Weak Signal 193
DELIVERY STATS screen 138, 139
discarding
transmitter 172
disconnecting
tester from transmitter 169
disposing
introducer needle 117
downloading pump data 3
Dual Wave bolus programming
with Bolus Wizard 85
without Bolus Wizard 82
dual/square option
on-off 82
Glucose Alerts
default settings 191
turning on 104
GLUCOSE ALERTS screen 104
Glucose Limits
default settings 191
Glucose Limits 1
default settings 192
Glucose Limits 2 through 8
default settings 192
glucose monitoring settings
entering
104, 105, 106, 108, 110,
111, 140
selecting BG units 105
setting AUC limits 140
setting Glucose Limits 104
setting Glucose Limits,
guidelines 106
setting Glucose Limits,
setting start time 106
Index
235
setting Glucose Limits,
switching limits off 106
setting Predictive
glucose alert 108
setting Rate of Change
alerts 110
setting the Cal
Reminder 111
turning on Glucose
Alerts 104
graphs 124
continuous glucose 122
continuous sensor glucose
levels 124
differentiating between
current and earlier events
in 123
opening 123, 124
green light
transmitter 168
H
high BG levels
Bolus Wizard and 65
HIGH BG warning 65
High Glucose Limit
alert 162
default settings 192
setting 104
High Predicted alert 163
High Predictive alert 109
High Repeat
default settings 192
setting 107
High Repeat alert
setting 108
High sensor glucose alert 162
history
alarms 133
bolus delivery 30
calibration 130
236
Index
delivered insulin 56
sensor alert 130
user settings 148
HOME screen 15
I
infection 6, 7
infusion set 2, 47
changing your 50
inserting 53, 54
best sites 54
rotating sites 54
initialization 118, 122
inserting sensor
best sites 115
guidelines 115
procedure 116
Sen-serter 116
sites to avoid 115
steps before 115
stopping bleeding 117
warning 115
Insulin sensitivity 68
introducer needle 116
disposing 117
removing 117
irritation
occlusive dressing 6, 7
skin 6
ISIG 168
I.V. Prep 116
L
Language setting 25
list
calibration values 130
sensor alert 130
Lock keypad feature 145
Lost Sensor alert 160
low battery
affects meter option 72
affects remote control 143
affects selftest 145
affects your alert type 133
low BG levels
Bolus Wizard and 65
LOW BG warning 65
Low Glucose
setting alert frequency 108
Low Glucose Limit
default settings 192
setting 104, 162
Low Predicted alert 162
Low Predictive
setting alert frequency 108
Low Repeat
default settings 192
setting 108
low reservoir alert 159
Low resv warning feature 134
Low sensor glucose alert 162
low transmitter battery 160
Low Transmtr alert 160
M
MAIN MENU 19
Max basal rate 43
MAX BOLUS EXCEEDED
warning 65
Maximum bolus limit 33
menus 19
meter 3, 61
entering BG 118, 120
Meter BG By alert 162
METER BG NOW alert 111
Meter BG Now alert 162
meter IDs
add, delete, review 73
meter option 72
rules 72
METER OPTION screen 73
METER STATS screen 139, 140
MiniLink transmitter 3
Missed Bolus alert 160
Missed Bolus Reminder 90
modes
Attention 18
Normal 18
Special 18
MWT1 3
MWT1 technology 61, 120
N
O
occlusive dressing
irritation 6, 7
reaction 6, 7
Other markers 39
P
pain 7
Patterns
basal 91
on/off 92
pattern A, B 91
R
Rate of Change alerts
sensitivity and alarm
frequency 110
reaction to occlusive
dressing 6, 7
reading the continuous glucose
graphs 122
RECONNECT OLD SENSOR 169
Reminder, alarm clock 142
remote control 3
remote control IDs
add, delete, review 143
Remote control option
turn on 143
removing
introducer needle 117
needle guard 116
sensor 118
removing your pump 21
reservoir
filling the 48
inserting in your pump 51
low reservoir warning 134
plunger rod 48
removing the 50
transfer guard 48
tubing connector 11
RESERVOIR + SET 20
reservoirs 2
Restore settings 147
REVIEW SETTINGS screen 113
reviewing
sensor settings 113
rewinding your pump 50
during practice 51
RF communications 200
RF features
meter 72
other devices 143
remote control 142
use on aircraft 8
Rise Rate alert 163
Index
needle guard 116
no delivery 153
Normal bolus
with Bolus Wizard 73
without Bolus Wizard 26
Normal mode 18
Now 86
Now portion
of the Dual Wave bolus 83, 86
Program a basal pattern 92
Select a basal pattern 93
standard basal pattern 91
Personal reminders 142
personal settings 61
practicing 51
precaution
sensor 7
Predictive Alerts 193
PREDICTIVE ALERTS LOW/
HIGH screen 109
preparing sensor sites 116
procedure, inserting sensor 116
programming sensor 103
pump
battery compartment 11
buttons 11, 13
if you remove your 21
screen 11, 15
using in water 157
warranty vi
S
Save settings 147
screens
DELIVERY STATS 138, 139
METER STATS 139, 140
SENSOR STATS 139
scroll bar 17
Scroll rate
setting 33
Selftest 145, 156
Sen-serter
inserting sensor 116, 117
removing from sensor 117
Sen-serter®
cleaning 173
Index
237
sensor
alerts 130, 159
history 130
list 130
best sites 115
calibrating 118, 162
caution inserting 115
choosing insertion site 115
default settings 191
disconnected 160
improper insertion 115
information 121
inserting 115, 116, 117
bleeding 117
guidelines 115
procedure 116
inserting sensor 115
ISIG 168
life 161
precaution 7
programming 103
reconnecting 169
removing 118
setting up 103
signal 115
signals 163
too high 163
too low 163
sites 116
preparing 116
stabilizing 161
starting 114
status screens 121
Transmitter ID 111
using in water 131
warnings 115
SENSOR ALERT HISTORY 130
sensor alerts
Alert Silence 159
Cal Error 161, 162
Change Sensor 161
Charge Transmtr 161
Fall Rate 163
238
Index
High Predicted 163
High XXX MG/DL 162
Lost Sensor 160
Low Predicted 162
Low Transmtr 160
Low XX MG/DL 162
Meter BG By 162
Meter BG Now 162
Missed Bolus 160
Rise Rate 163
Sensor End 161
Sensor Error 163
Weak signal 159
Sensor Demo 114
SENSOR DEMO ON/OFF
screen 114
Sensor End alert 161
Sensor Error alert 163
Sensor function 19
sensor glucose graph
timeout 113
default settings 193
sensor glucose graphs
continuous display 113
WARM UP 122
sensor glucose levels
graphs 124
sensor graph
example 114
SENSOR ON/OFF screen 103
SENSOR STATS screen 139
SENSOR STATUS 121
SET AUC LIMITS screen 140
SET CAL REMINDER screen 111
SET CAL REPEAT screen 111
SET FALL RATE LIMIT screen 110
SET GLUCOSE LIMITS 1
screen 106
SET GRAPH TIMEOUT screen 113
SET HI ALERT REPEAT
screen 108
SET LO ALERT REPEAT
screen 108
SET RISE RATE LIMIT screen 110
SET TIME SENSITIVITY LOW/
HIGH screen 109
SET TRANSMITTER ID screen 112
SET WEAK SIGNAL screen 112
setting
Cal Reminder 111
Cal Repeat 111
High Repeat 107
Low Repeat 108
sensor glucose graph
timeout 113
setting up sensor 103
settings
entering
104, 106, 108, 110, 111, 140
glucose monitoring
settings, setting AUC
limits 140
glucose monitoring
settings, setting
Glucose Limits,
guidelines 106
glucose monitoring
settings, setting
Glucose Limits, setting
start time 106
glucose monitoring
settings, setting
Predictive glucose
alert 108
Square Wave bolus programming
with Bolus Wizard 85
without Bolus Wizard 82
starting sensor
steps before 114
STATUS screen 20
Step value setup 88
stopping bleeding 117
supplies, ordering 3
Suspend function 19, 44
swelling 6, 7
swimming 131
system initialization 118
T
Temp basal
canceling 99
delivering 98
rates 94
selecting type 98
verify delivery 99
temp basal types
Insulin rate 95
Percent of basal 96
tenderness 7
terms and symbols 4
test plug. See tester 168
tester 3
connecting to
transmitter 168
disconnecting from
transmitter 169
transmitter 114
water-tightness 172
therapy follow-up
Recommended 151
time and date, setting 23
transmitter
before attaching 117
charger 114
cleaning 172
depleted battery 161
discarding 172
disconnected 160
green light 168
low battery 160
signal 115
tester 3, 114
using in water 131
warning 6
Transmitter ID
setting 111
troubleshooting 169
tubing
filling 52
U
Index
glucose monitoring
settings, setting Rate
of Change alerts 110
glucose monitoring
settings, setting the
Cal Reminder 111
glucose monitoring
settings, turning on
Glucose Alerts 104
glucose
monitoring 104, 106, 108,
110, 111, 140
setting AUC limits 140
setting Glucose Limits 104
setting Glucose Limits,
guidelines 106
setting Glucose Limits,
setting start time 106
setting Predictive
glucose alert 108
setting Rate of Change
alerts 110
setting the Cal
Reminder 111
turning on Glucose
Alerts 104
sensor glucose graph
timeout 113
settings, reviewing 113
showering 131
silent alerts 129
sites
inserting sensor 115
skin
bleeding 6, 7
bruising 7
infection 6, 7
redness 7
swelling 6, 7
Special mode 18
Square portion
of the Dual Wave bolus 86
user safety
adverse reactions 7
User settings 146
User Settings screen 157
using the Capture Event
feature 35
Utilities 133
UTILITIES MENU 20
V
viewing
calibration values 130
sensor alert history 130
W
WARM UP 122
warnings
sensor 6
transmitter 6
warranty vi
water, using your system in 131
Index
239
water-tightness 131
charger 172
tester 172
Weak Signal 159
default settings 193
Weak Signal alert 159
Weak Signal feature 112
description 112
240
Index
6025306-012C_a
User Guide
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