Medtronic Paradigm 522 User guide

Medtronic Paradigm 522 User guide
INSULIN PUMP AND
CONTINUOUS GLUCOSE MONITORING SYSTEM
Insulin Pump User Guide
Paradigm®
522 and 722 Insulin Pumps
User Guide
©2008 Medtronic MiniMed, Inc. All rights reserved.
This product is covered by U.S. Patent Nos. 6,551,276; 6,554,798; 6,872,200; 6,936,029; 6,979,326; 6,997,920 and
7,025,743. Other U.S. and/or foreign patents may be pending.
Bolus Wizard®, Dual Wave®, Guardian®, Guardian RT®, Paradigm®, Paradigm Link®, Quick-serter®, Quick-set®, Sen-serter®,
Silhouette®, Sof-set®, and Square Wave® are registered trademarks of Medtronic MiniMed, Inc.
CareLink™ Personal, Easy Bolus™, and MiniLink™ are trademarks of Medtronic MiniMed, Inc.
Energizer® is a registered trademark of Eveready Battery Company.
LifeScan®, OneTouch®, OneTouch®Ultra® and OneTouch®UltraLink™ are trademarks of LifeScan, Inc.
Glucagon Emergency Kit® is a registered trademark of Eli Lilly and Company.
YSI 2300 STAT Plus™ is a trademark of YSI Inc.
6025250-013_b
REF MMT-522 MMT-522K MMT-722 MMT-722K
Contacts:
Africa:
Medtronic Africa (Pty) Ltd.
Tel: +27 (0) 11 677 4800
Eire:
Accu-Science LTD.
Tel: +353 45 433000
Australia:
Medtronic Australasia Pty. Ltd.
Tel: 1800 668 670 (product orders)
Tel: 1800 777 808 (customer help)
España:
Medtronic Ibérica S.A.
Tel: + 34 91 625 05 42
Fax: +34 91 625 03 90
Belgie/Belgique:
N.V. Medtronic Belgium S.A.
Tel: 02-456-0900
Europe:
Medtronic Europe S.A. Europe,
Middle East and Africa Headquarters
Tel: +41 (0) 21-802-7000
Brasil:
Medtronic Comercial Ltda.
Tel: +(11) 3707-3707
Canada:
Medtronic of Canada Ltd.
Tel: 1-800-284-4416 (toll free/sansfrais)
Ceska Republika:
Medtronic Czechia s.r.o.
Tel: +420 296 579 580
France:
Medtronic France S.A.S.
Tel: +33 (0) 1 55 38 17 00
Hellas:
Medtronic Hellas S.A.
Tel: +30 210677-9099
China:
Medtronic (Shanghai) Ltd.
Tel: +86 40 0820 1981
or 80 0820 1981
Italia:
Medtronic Italia S.p.A.
Tel. +39 02 24137 261
Servizio assistenza tecnica: No verde
24h: 800 712 712
Tel. 06-328141
Fax 06-3215812
Danmark:
Medtronic Danmark A/S
Tel: +45 32 48 18 00
Japan:
Medtronic Japan Co. Ltd.
Tel: +81-3-6430-2019
Deutschland:
Medtronic GmbH
Geschäftsbereich Diabetes
Telefon: +49 2159 8149-370
Telefax: +49 2159 8149-110
24-Stdn-Hotline: 0800 6464633
Latin America:
Medtronic, Inc.
Tel. +1-305-500-9328
Fax +1-786-709-4244
East Asia:
Medtronic International Ltd.
Tel: +852 2891 4300
Latvija:
Ravemma Ltd.
Tel: +371 7273780
Magyarország:
Medtronic Hungária Kft.
Tel: +36 1 889 0600
Malaysia:
Medtronic International Ltd.
Tel: (+65) 6436-5094
or (+65) 6436-5097
Middle East and North Africa:
Regional Office
Tel: +961-1-370 670
Nederland, Luxembourg:
Medtronic B.V.
Tel: +31 (0) 45-566-8290
New Zealand:
Medica Pacifica
Tel: +0800 106 100
After-Hours:
+0800 633 487
Norge:
Medtronic Norge A/S
Tel: +47 67 10 32 00
Fax: +47 67 10 32 10
POCCИЯ:
Medtronic B. V.
Tel: +7 095 5807377/1161
Polska:
Medtronic Poland Sp. z.o.o.
Tel: +48 22 4656 900
Portugal:
Medtronic Portugal Lda
Tel: +351 21 7245100
Fax: +351 21 7245199
Puerto Rico:
Medtronic Puerto Rico
Tel: 787-753-5270
Republic of Korea:
Medtronic Korea, Co., Ltd.
Tel: +82.2.3404.3600
Schweiz:
Medtronic (Schweiz) AG
Tel: + 41 (0)31 868 0160
24-Stunden-Hotline 0800 633 333
Fax Allgemein: +41 (0)31 8680199
Serbia & Montenegro:
Novolab Serbia & Montenegro
Epsilon Research Ltd.
Tel: +381 63 219 827
Singapore:
Medtronic International Ltd.
Tel: (+65) 6436-5094
or (+65) 6436-5097
Slovenija:
Zaloker & Zaloker d.o.o.
Tel: +34 91 625 0400
Slovenská Republika:
Medtronic Slovakia o.z.
Tel: +421 2 68 20 69 12
Suomi:
Medtronic Finland OY
Tel: +358-9-755 25 00
Sverige:
Medtronic AB
Tel: +46 8 568 585 00
Fax: +46 8 568 585 01
Taiwan:
Medtronic-Mediland Ltd.
Tel: +886.2.2517.0308
Thailand:
Medtronic (Thailand) Ltd.
Tel: (+65) 6436-5094
or (+65) 6436-5097
Turkiye:
Medtronic Medikal Teknoloji
Ticaret Ltd. Sirketi.
Tel: +90 216 4694330
USA:
Medtronic Diabetes Global
Headquarters
Tel: +1-800-826-2099
24-hour Help Line: +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
Important Safety Information
Regarding Your Insulin Pump
(includes all models)
Avoid Immersing Your Pump In Water
The pump was tested and met requirements for IPX7 at time of manufacture. For more information about
IPX7, see the Glossary on page 229. Be aware that drops and bumps that occur over time will affect the
integrity of the pump case and make it more vulnerable to damage from water. Lotions, sunscreens and
insect repellent can also damage the pump case. It is not known how much water is needed to damage
your pump. You should avoid getting your pump wet. To shower, bathe, swim, or participate in water
activities, always disconnect from your 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. 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.
Contents
Chapter 1: Introduction ..................................................................... 1
Assistance ...................................................................................................... 1
Emergency kit ................................................................................................. 2
Consumables .................................................................................................. 3
Accessories .................................................................................................... 3
How to wear your pump ..................................................................................... 4
How to use this guide ........................................................................................ 5
User safety ..................................................................................................... 6
Indications: Paradigm 522/722 .......................................................................... 6
Pump ...................................................................................................... 6
Sensor and transmitter ................................................................................. 6
Indications: Paradigm 522K/722K (pediatric version) ................................................ 6
Pump ...................................................................................................... 6
Sensor and transmitter ................................................................................. 6
Meter ...................................................................................................... 7
Contraindications .......................................................................................... 7
Warnings ..................................................................................................... 7
Pump ...................................................................................................... 7
Reservoir and infusion sets ............................................................................ 7
Tubing Connector ........................................................................................ 8
Sensor ..................................................................................................... 8
Transmitter ............................................................................................... 8
Magnetic fields .......................................................................................... 9
X-rays, MRIs and CT scans .............................................................................. 9
Precautions ................................................................................................. 9
Avoid extreme temperatures .......................................................................... 9
Infusion sets and sites ................................................................................. 10
Sensor ................................................................................................... 10
Contents
vii
Adverse reactions ........................................................................................
Notice .........................................................................................................
Insulin pump and RF accessories .......................................................................
RF interference from other devices ...................................................................
10
10
10
11
Chapter 2: Introduction to pump therapy .............................................. 13
Theory of insulin pump therapy ...........................................................................
Understanding pump therapy .............................................................................
Basal rate ..................................................................................................
Meal bolus .................................................................................................
Gram counting .........................................................................................
Exchange counting .....................................................................................
BG targets .................................................................................................
Insulin sensitivity .........................................................................................
Active Insulin ..............................................................................................
Blood glucose and A1C testing ............................................................................
BG testing .................................................................................................
A1C .........................................................................................................
Low blood glucose (hypoglycemia) .......................................................................
Hypoglycemia protocol: the rule of 15 ................................................................
High blood glucose (hyperglycemia) .....................................................................
Hyperglycemia protocol .................................................................................
Diabetes ketoacidosis (DKA) ...............................................................................
Preventing DKA ...........................................................................................
Sick day management ......................................................................................
Sick day protocol .........................................................................................
Sick day supplies ..........................................................................................
Nutrition ......................................................................................................
Carbohydrate counting ..................................................................................
Carbohydrate gram counting .........................................................................
Carbohydrate exchange system .....................................................................
Reading a food label .....................................................................................
Fat and blood glucose ...................................................................................
Protein and blood glucose ...............................................................................
Other things that affect blood glucose ...............................................................
Healthy eating habits ....................................................................................
Exercise .......................................................................................................
viii
Contents
13
14
14
14
14
14
14
15
15
15
15
15
17
18
19
19
20
20
21
21
22
22
22
23
23
23
24
25
25
26
26
Chapter 3: The basics ...................................................................... 27
Your pump ....................................................................................................
Install battery ................................................................................................
Pump buttons ................................................................................................
The pump screen ............................................................................................
HOME screen .................................................................................................
Screen icons ...............................................................................................
Battery ..................................................................................................
Time display ............................................................................................
Reservoir volume ......................................................................................
Alert and alarm icons .................................................................................
Sensor icons ............................................................................................
Scroll bar ..................................................................................................
Screen backlight ..........................................................................................
Beep/vibrate .................................................................................................
Operating modes ............................................................................................
Normal mode ..............................................................................................
Special mode ..............................................................................................
Attention mode ...........................................................................................
Menus .........................................................................................................
MAIN MENU ................................................................................................
BOLUS MENU ...............................................................................................
SUSPEND ...................................................................................................
BASAL MENU ...............................................................................................
SENSOR .....................................................................................................
PRIME MENU ...............................................................................................
UTILITIES MENU ...........................................................................................
STATUS screen ...............................................................................................
If you remove your pump ..................................................................................
27
28
29
31
31
32
32
32
32
32
33
33
33
33
33
34
34
34
35
35
35
35
35
35
36
36
36
37
Chapter 4: Basic programming ............................................................ 39
Setting the time and date .................................................................................
Selecting the language .....................................................................................
Bolus ..........................................................................................................
Setting the Normal bolus ................................................................................
Review your bolus deliveries ..............................................................................
Bolus details ...............................................................................................
39
40
41
41
45
47
Contents
ix
Maximum bolus limit ........................................................................................
BG Reminder .................................................................................................
Basal ..........................................................................................................
Start and stop times .....................................................................................
Your basal settings .......................................................................................
Basal programming and delivery ....................................................................
Current basal delivery ...................................................................................
Daily basal rate(s) .....................................................................................
Setting the Max basal rate .................................................................................
Stopping your pump ........................................................................................
Resume pump delivery .....................................................................................
48
49
49
50
51
51
52
52
54
55
55
Chapter 5: Starting on insulin ............................................................ 57
Prepare your pump for use ................................................................................
Filling the reservoir .........................................................................................
Changing your infusion set .................................................................................
Removing the reservoir .................................................................................
Rewinding your pump ...................................................................................
Inserting the reservoir in your pump .................................................................
Manual prime ..............................................................................................
Inserting the infusion set ................................................................................
Quick-set infusion set (with Quick-serter®) ..........................................................
Fixed prime ................................................................................................
Prime history ..............................................................................................
Disconnecting Quick-set .................................................................................
Reconnecting Quick-set .................................................................................
Record keeping for diabetes management ..............................................................
Determining your pump settings ..........................................................................
57
58
60
60
62
62
64
65
66
67
67
67
68
68
69
Chapter 6: Using the Bolus Wizard feature ............................................ 71
What is it? ....................................................................................................
Carbohydrate counting ..................................................................................
Your blood glucose reading .............................................................................
Your personal Bolus Wizard feature settings .........................................................
How the Bolus Wizard feature works .....................................................................
Bolus Wizard warnings ......................................................................................
HIGH BG ....................................................................................................
x
Contents
71
71
71
72
75
75
75
LOW BG ....................................................................................................
MAX BOLUS EXCEEDED ...................................................................................
How to program the Bolus Wizard feature ..............................................................
Turning on the Bolus Wizard feature .................................................................
Selecting the Carb units ................................................................................
Setting the Carb/Exch ratios ...........................................................................
Setting the BG units .....................................................................................
Insulin sensitivity ........................................................................................
Setting the BG Targets ..................................................................................
About active insulin ......................................................................................
Active insulin time .......................................................................................
Review your Bolus Wizard feature settings .............................................................
Meter option .................................................................................................
Meter rules ...............................................................................................
Add, delete, review meter IDs ........................................................................
Normal bolus using Bolus Wizard feature ................................................................
Bolus Wizard feature examples ...........................................................................
76
76
76
77
77
77
78
79
80
81
82
82
83
84
84
85
86
Chapter 7: Optimizing pump therapy ................................................... 91
Square Wave and Dual Wave bolus ....................................................................... 91
Turning on the Dual Wave/Square Wave option ..................................................... 92
Square Wave or Dual Wave bolus without Bolus Wizard feature ................................. 92
Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus .......................... 95
Easy bolus .................................................................................................... 97
Easy bolus setup .......................................................................................... 97
Step value setup ......................................................................................... 97
Delivering Easy Bolus .................................................................................... 98
Basal patterns .............................................................................................. 100
Turning on the patterns ............................................................................... 100
Programming a pattern ................................................................................ 100
Select a pattern ........................................................................................ 101
Temp basal rates ........................................................................................... 102
How does temp basal work? ........................................................................... 103
Temp basal types ........................................................................................ 103
Insulin rate (U/H) .................................................................................... 103
Percent of basal ...................................................................................... 105
Contents
xi
Chapter 8: Sensor features .............................................................. 111
Entering your sensor settings ............................................................................
Turning on the sensor ...................................................................................
Selecting the BG units ..................................................................................
High Glucose Alert ......................................................................................
Setting the High Snooze ................................................................................
Low Glucose Alert .......................................................................................
Setting the Low Snooze ................................................................................
Setting the Alarm Snooze .............................................................................
Setting the Cal Reminder ..............................................................................
Entering the transmitter ID ............................................................................
Setting up the Missed Data feature ..................................................................
Reviewing your settings ...............................................................................
The transmitter ............................................................................................
Transmitter charger .......................................................................................
Charging the transmitter ..............................................................................
Starting the sensor ........................................................................................
Inserting the sensor .......................................................................................
Connecting the transmitter to the sensor .............................................................
Preparing the sensor for communication ...............................................................
Calibrating the sensor ....................................................................................
Entering meter BG .........................................................................................
111
111
112
112
113
113
114
114
115
115
116
116
117
117
117
119
119
122
123
123
124
Chapter 9: Using your sensor ............................................................ 125
Status screens ..............................................................................................
Reading the sensor glucose graphs ......................................................................
Opening and viewing the graphs ......................................................................
The graphs ...............................................................................................
Examples of real-time sensor glucose graphs .......................................................
3-hour graph ..........................................................................................
24-hour graph .........................................................................................
How to check for rapid changes in sensor glucose ...................................................
The rapid change arrows ...............................................................................
Calibration history .........................................................................................
Sensor alarm history ......................................................................................
Disconnecting the transmitter and removing the sensor ............................................
Disconnecting the sensor from the transmitter ....................................................
xii
Contents
125
125
126
127
128
128
129
129
129
131
131
132
132
Removing the sensor .................................................................................... 132
Storage ...................................................................................................... 132
Using your system in water ............................................................................... 133
Chapter 10: Utilities ...................................................................... 135
Alarm review ...............................................................................................
Setting your alert type ....................................................................................
Auto-off .....................................................................................................
LOW RESV WARNING (Low reservoir warning) .........................................................
Review daily insulin totals ................................................................................
Pump data management ..................................................................................
Meter blood glucose information .....................................................................
Personal reminders ........................................................................................
Alarm clock ..............................................................................................
Remote control option ....................................................................................
Turn on remote control option .......................................................................
Add, delete, review remote control IDs ............................................................
Block feature ...............................................................................................
Turning block on ........................................................................................
Lock keypad feature ......................................................................................
Locking the keypad .....................................................................................
Unlocking the keypad ..................................................................................
Selftest ......................................................................................................
User settings ................................................................................................
Saving the settings .....................................................................................
Restoring the settings .................................................................................
Clearing the settings ...................................................................................
History ...................................................................................................
135
135
136
136
137
138
138
141
141
141
142
142
143
143
144
144
144
144
145
145
146
147
147
Chapter 11: Therapy software .......................................................... 149
CareLink™ Personal Software ............................................................................ 149
Reports ................................................................................................... 149
Logbook ................................................................................................... 150
Chapter 12: Insulin pump therapy follow-up ......................................... 151
Recommended follow-up ................................................................................. 151
Everyday .................................................................................................. 151
Contents
xiii
Every month .............................................................................................
Every 3 months ..........................................................................................
Laboratory tests .........................................................................................
Every visit ................................................................................................
Annually ..................................................................................................
151
151
152
152
152
Chapter 13: Troubleshooting and alarms ............................................. 153
My pump has a NO DELIVERY alarm .....................................................................
What happens if I leave the pump battery out too long? ............................................
Why does my pump battery not last very long? .......................................................
What is a CHECK SETTINGS alarm? ......................................................................
My screen appears distorted .............................................................................
I cannot get out of the priming loop ....................................................................
The pump is asking me to rewind .......................................................................
My bolus stopped ..........................................................................................
My pump buttons are not acting right during a bolus ................................................
My pump will not display my blood glucose reading from my meter ..............................
I dropped my pump ........................................................................................
I submerged my pump in water .........................................................................
I cannot get to the User Settings screen ...............................................................
Alerts ........................................................................................................
What to do ...............................................................................................
Pump alert conditions ..................................................................................
LOW RESERVOIR ......................................................................................
LOW BATTERY .........................................................................................
Sensor alert conditions .................................................................................
WEAK SIGNAL ..........................................................................................
LOST SENSOR .........................................................................................
LOW TRANSMTR ......................................................................................
BAD TRANSMTR .......................................................................................
BAD SENSOR ...........................................................................................
SENSOR END ...........................................................................................
CAL ERROR ............................................................................................
METER BG NOW .......................................................................................
METER BG BY ..........................................................................................
LOW XX MG/DL (XX = SG measurement) ..........................................................
HIGH XXX MG/DL (XXX = SG measurement) ......................................................
xiv
Contents
153
154
154
155
155
156
156
156
156
157
157
158
158
158
159
160
160
160
160
160
161
161
162
162
162
162
163
163
163
163
SENSOR ERROR ........................................................................................
Alarms .......................................................................................................
What to do ...............................................................................................
Alarm conditions ...........................................................................................
A (ALARM) ...............................................................................................
AUTO OFF ................................................................................................
BATT OUT LIMIT .........................................................................................
BOLUS STOPPED ........................................................................................
BUTTON ERROR ..........................................................................................
CHECK SETTINGS .......................................................................................
E (ERROR) ...............................................................................................
EMPTY RESERVOIR ......................................................................................
FAILED BATT TEST ......................................................................................
MAX DELIVERY ...........................................................................................
MOTOR ERROR ...........................................................................................
NO DELIVERY .............................................................................................
NO RESERVOIR ...........................................................................................
OFF NO POWER ..........................................................................................
RESET .....................................................................................................
WEAK BATTERY ..........................................................................................
Testing the transmitter ...................................................................................
Connecting the tester ..................................................................................
Disconnecting the tester ...............................................................................
Troubleshooting sensor features ........................................................................
Reconnect old sensor ...................................................................................
Find lost sensor ..........................................................................................
Understanding your transmitter, tester, and charger ..............................................
163
164
164
165
165
165
165
165
166
166
166
166
166
166
166
167
167
167
167
167
167
167
168
169
169
169
170
Chapter 14: Maintenance ................................................................ 173
Battery ......................................................................................................
Storage ......................................................................................................
Cleaning your pump .......................................................................................
Cleaning the transmitter .................................................................................
Cleaning the Sen-serter ...................................................................................
173
174
174
174
175
Chapter 15: Pump specifications ....................................................... 177
Alarms and error messages ............................................................................... 177
Contents
xv
Alarm history ...............................................................................................
Audio frequency ...........................................................................................
Backlight ....................................................................................................
Basal .........................................................................................................
BG Target ...................................................................................................
Bolus delivery ..............................................................................................
Bolus history ................................................................................................
Bolus units ..................................................................................................
Bolus Wizard feature ......................................................................................
Carb ratios ..................................................................................................
Carb units ...................................................................................................
Daily totals ..................................................................................................
Default screen ..............................................................................................
Delivery accuracy ..........................................................................................
Pump motor ................................................................................................
Dual Wave bolus ............................................................................................
Easy bolus ...................................................................................................
Infusion pressure ...........................................................................................
Insulin sensitivity ..........................................................................................
Low resv (reservoir) warning .............................................................................
Meter value .................................................................................................
Normal bolus ...............................................................................................
Occlusion detection .......................................................................................
Percent temp basal ........................................................................................
Power supply ...............................................................................................
Prime function .............................................................................................
Prime history ...............................................................................................
Program safety checks ....................................................................................
Pump size ...................................................................................................
Pump weight ................................................................................................
Remote control .............................................................................................
Reservoir ....................................................................................................
Square Wave bolus .........................................................................................
Temporary (temp) basal rate ............................................................................
Time and date screen .....................................................................................
Environmental conditions ................................................................................
Status screen ...............................................................................................
xvi
Contents
177
177
177
178
178
178
178
178
178
179
179
179
179
180
181
181
181
181
181
182
182
182
182
183
183
183
183
183
183
183
184
184
184
184
184
184
185
Bolus Wizard feature specifications ....................................................................
Bolus Wizard feature examples ..........................................................................
Insulin delivery default settings .........................................................................
Bolus Wizard feature default settings ..................................................................
Sensor features default settings .........................................................................
Guidance and manufacturer's declaration .............................................................
Icon table ...................................................................................................
Warranty ....................................................................................................
186
190
193
195
196
197
204
206
Appendix A: Sensor accuracy ............................................................ 207
Performance results in adults ............................................................................
Accuracy of Guardian RT readings ......................................................................
Precision of Guardian RT readings ......................................................................
Low and High Alerts in adults ............................................................................
The Low Glucose Alert .................................................................................
The High Glucose Alert .................................................................................
Guardian RT sensor performance and calibration stability as a function of time ...............
Effects of calibration frequency .........................................................................
Time-elapsed plots ......................................................................................
Performance results in children and adolescents .....................................................
Accuracy of Guardian RT readings ....................................................................
Low and High Alerts in children and adolescents .....................................................
The Low Glucose Alert .................................................................................
The High Glucose Alert .................................................................................
208
209
213
214
214
215
216
219
220
223
223
227
227
228
Glossary ...................................................................................... 229
Index ......................................................................................... 237
Contents
xvii
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® 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 pumprelated 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
Introduction
1
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
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.
2
Introduction
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.
•
Chapter 1
•
Reservoirs — The 522/522K pump is only used with the 176-unit Paradigm reservoir (MMT-326A). The
722/722K pump can be used with either the 300-unit Paradigm reservoir (MMT-332A) or the 176-unit
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.
Accessories
•
•
•
•
•
Meter — Your pump can be used with an optional blood glucose meter powered by MWT1 technology
(where or if available). MWT1 is the wireless Radio Frequency (RF) technology that is used to transmit
information from the meter to the pump. You can program your pump to automatically receive your
BG reading from this meter. All meters referenced in this user guide are blood glucose meters
supported by MWT1 technology.
Remote control — The optional Paradigm remote control can be used with the pump to deliver normal
boluses and suspend/resume the pump from a distant location. (This user guide provides programming
instructions for the remote control. Refer to the remote control user guide for operating instructions.)
Medtronic MiniLink™ Transmitter — The transmitter (MMT-7703) is a small device that connects to the
sensor. It comes with a tester and a charger. When connected to a sensor that is inserted in the body,
the transmitter automatically initializes the sensor and begins to periodically send glucose data to the
pump using a radio signal.
Sensor — The sensor (MMT-7002/MMT-7003) continuously converts tiny amounts of glucose from your
fatty layer under the skin into an electronic signal. This signal is sent to the transmitter.
CareLink USB Upload Device — The Medtronic Diabetes CareLink USB is used to download your pump
data to the diabetes management software using a USB port on your computer.
Introduction
3
Not all devices or accessories are available in all countries where the pump is approved.
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.
•
•
•
•
4
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. A flap
with a hook-and-loop fastener provides easy access for programming. Wear it vertically with the builtin belt clip.
Introduction
How to use this guide
NOTE:
This user guide shows sample screens only. Your pump screens may be slightly different.
Conventions
Meaning
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
Chapter 1
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.
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
From the MAIN MENU, select Utilities and press ACT.
2
In the UTILITIES MENU, select Alarm and press ACT.
3
The ALARM MENU appears.
Introduction
5
User safety
Indications: Paradigm 522/722
Pump
The Paradigm MMT-522 and MMT-722 pumps are indicated for the continuous delivery of insulin, at set and
variable rates, for the management of diabetes mellitus in persons requiring insulin.
Sensor and transmitter
The sensor and transmitter components are 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). It alerts if a glucose level falls below or rises above preset values. Values 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 blood
glucose meter and not on Paradigm 522/722 pump system values.
Indications: Paradigm 522K/722K (pediatric version)
Pump
The Paradigm MMT-522K and MMT-722K insulin infusion pumps are indicated for the continuous delivery of
insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Sensor and transmitter
The Paradigm REAL-Time system (pediatric version) consists of the Paradigm MMT-522K or MMT-722K insulin
infusion pumps, the MMT-7002 or MMT-7003 glucose sensor, and the MMT-7703 transmitter. Use of the
MMT-522K and MMT-722K 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 system provides an alert
if glucose levels fall below or rise above preset values. Glucose values provided by the system 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
blood glucose meter and not on the sensor glucose readings provided by the Paradigm REAL-Time system.
6
Introduction
Meter
The Paradigm REAL-Time insulin pump can be programmed to receive fingerstick blood glucose values
transmitted from the LifeScan 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.
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.
Chapter 1
Contraindications
Warnings
Pump
The drive support cap should appear slightly indented at all times
(as shown in the image). If you notice that the cap is loose, or
sticking out, discontinue use of the pump and contact our
24 Hour HelpLine at 1 800 646 4633 to arrange for your pump to
be replaced. Do not press on the drive support cap if it is
sticking out. Pushing on the drive support cap may result in
unintended delivery of insulin, which can cause hypoglycemia.
drive support cap
Reservoir and infusion sets
Standard Luer sets are not compatible with the Medtronic MiniMed Paradigm pump. Medtronic Diabetes
Paradigm reservoir 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.
Introduction
7
Tubing Connector
If insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow the
pump to properly prime the infusion set. This may result in the delivery of too little or too much insulin,
which can cause hypoglycemia or hyperglycemia. To prevent liquid from getting inside the tubing
connector, after you fill the reservoir make sure you hold the insulin vial upright when you remove the
reservoir from the transfer guard. If you do not hold the insulin vial upright, insulin can get on the top of
the reservoir and could transfer liquid into the tubing connector. If any liquid gets on the top of the
reservoir or inside the tubing connector when you change your infusion set, start over with a new reservoir
and infusion set. For instructions on setting up your reservoir, see Filling the reservoir, on page 58. For
instructions on changing your infusion set, see Changing your infusion set, on page 60.
Top of
reservoir
Tubing
connector
Sensor
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 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.
The transmitter should be disconnected from the sensor while traveling on an aircraft, or if it interferes
with another transmitting device.
8
Introduction
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.
If your pump is inadvertently exposed to a strong magnetic field, discontinue use and contact your local
help line or representative for further assistance.
Chapter 1
Your pump must be removed and kept outside the room during magnetic resonance imaging (MRI)
procedures.
X-rays, MRIs and CT scans
If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, take off your pump,
sensor, transmitter, meter and remote control before entering a room containing any of these
equipment.
The Paradigm pump is designed to withstand common electromagnetic interference, including airport
security systems. Be sure to carry the Emergency Card provided, when you are traveling. This card
provides airport information.
Precautions
Although the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has
lost its potency. It is essential, therefore, that you test your blood glucose levels at least four times per
day. If your blood glucose is out of range, check the pump and the infusion set to ensure that the
necessary amount of insulin is being delivered.
Avoid extreme temperatures
1
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.
Introduction
9
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 the 24
Hour HelpLine in the event of any adverse reaction.
Notice
CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic Diabetes
could void your ability to operate the equipment.
Insulin pump and RF accessories
The pump, meter, transmitter and remote control comply with the United States Federal Communications
Commission and international standards for electromagnetic compatibility.
Do not use the RF meter to send your blood glucose reading to the pump while on an aircraft. Manually
enter your blood glucose. Do not use the sensor feature while on an aircraft.
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.
10
Introduction
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
Chapter 1
2
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 your local
representative.
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 and alarms
chapter to correct interference problems you may have.
Wireless transmission between the pump and transmitter within the two-meter 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 > Sensor Start > Find Lost Sensor
If you have questions, please contact the 24 Hour HelpLine.
RF interference from other devices
Common consumer electronic devices that transmit in the same frequency band used by the MMT-7703
MiniLink transmitter may prevent the pump from receiving the glucose information sent by the
transmitter. Most cellular (mobile) phones and 900 MHz cordless phones, when transmitting or receiving,
may cause significant interruption of transmitter-receiver communication. It is likely that other devices
operating in similar frequency ranges will have a similar effect. This interference, however, will not cause
any incorrect data to be sent and will not cause any harm to your transmitter.
Introduction
11
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.
12
Introduction
Introduction to pump therapy
Theory of insulin pump therapy
All people, with or without diabetes, need background insulin for normal functions of the body without
food. They also need a dose of insulin on demand - when food is eaten. People without diabetes can trust
that their pancreas will produce this insulin for them. People with diabetes need to take insulin in a way
that is most like the way a pancreas produces it.
Chapter 2
Insulin pumps deliver insulin closer to the way the human pancreas delivers insulin than any other method
of treating diabetes.
Most people with diabetes who take more than one daily injection, use long-acting insulin. This takes care
of their background insulin needs. They take fast-acting insulin for food. When using an insulin pump, only
fast-acting insulin is used. You control when and at what rate your insulin is delivered.
Insulin pump therapy allows you to set a basal rate, or background insulin. This is delivered all throughout
the day and night for normal body function without food. When you exercise, you can reduce the basal
rate so that your blood glucose (BG) does not drop too low. When you are sick or have an infection, you
can increase the basal rate. This will keep your BG from going up too high.
Insulin pump therapy allows you to give a bolus, or dose of insulin on demand - when you eat. You can also
increase or decrease your meal bolus based on the foods you choose to eat. A bolus may also be used to
lower an elevated BG. This is called a correction bolus.
The Paradigm pump also contains an optional feature called the Bolus Wizard. This does the math for the
required bolus amount based on your personal settings. The Bolus Wizard will use your BG reading,
carbohydrate intake, and active insulin when coming up with your bolus amount.
Remember, the pump uses only fast-acting insulin. This means you will not need to follow as rigid a
schedule as you did before. There is no long-acting insulin telling you when you should eat or when you
will need more insulin.
Sound exciting? It is exciting because not only can you manage your blood glucose more easily, your
lifestyle can be easier too.
Introduction to pump therapy
13
As long as you are ready to learn how to use the pump, the pump can work for you.
Understanding pump therapy
If you are new to pump therapy, you will need the following data from your healthcare professional.
Gather this before going to your pump start appointment. If you are unsure, contact your healthcare
professional or pump trainer for guidance.
Basal rate
Basal insulin is needed to maintain your target glucose values when you are not eating. Your pump allows
up to 48 basal rates to be programmed. Your healthcare professional may only have you program one or
two basal rates when you start pump therapy.
Meal bolus
Deliver a meal bolus before eating carbohydrates. Your insulin to carbohydrate ratio is the amount of
insulin required to cover a given number of carbohydrates or exchanges. This ratio gives you an idea of
how much of an insulin bolus you should take when eating carbohydrates.
Gram counting
1.0 unit of insulin for __________ grams of carbohydrate
Exchange counting
__________ units of insulin for each carbohydrate exchange
BG targets
The Bolus Wizard will use your BG targets to calculate a correction dose. Keeping your BG within target
range is key to living well with diabetes. Your healthcare professional should help you decide these
targets.
14
Introduction to pump therapy
Insulin sensitivity
Insulin sensitivity is used to decide a correction bolus for a high BG. This is how much your blood glucose
will be dropped with 1 unit of insulin.
1 unit of insulin will lower BG __________ mg/dL (mmol/L).
Active Insulin
Blood glucose and A1C testing
When you check your blood glucose with a meter, you measure blood glucose at the moment you perform
the test. This number gives you key feedback for making present and day-to-day adjustments in your
diabetes management. The A1C test, done at your doctor's, shows you your average blood glucose over the
last 60 to 90 days. Both blood glucose and A1C testing are necessary for good diabetes management.
Chapter 2
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.
BG testing
With any insulin therapy, you must monitor your blood glucose four to six times a day. With insulin pump
therapy, blood glucose testing gives you correct feedback. It also allows you to make prompt changes
based on the results. It alerts you to high blood glucose readings that need changing. It allows you to
adjust your insulin to carbohydrate ratio for certain foods. Your pump only uses fast-acting insulin; as a
result, you have no long-acting insulin as a back-up. Therefore, if your insulin delivery is disrupted on
pump therapy, your blood glucose can go dangerously high fairly fast. This can happen much faster than it
could when you were using daily injections with long-acting insulin. Blood glucose testing is needed to
alert you to high blood glucose so you can prevent diabetic ketoacidosis (DKA).
A1C
A1C testing also plays a key part in diabetes management. Sustained high BG levels can cause serious longterm problems. These problems may be prevented and/or delayed if you maintain your blood glucose
levels close to normal. The best measure of your overall blood glucose is the A1C test. It has been proven
that an A1C level of 7.0 or less greatly reduces the risk of problems from diabetes. But, any reduction in
A1C is a plus. ADA Clinical Practice Recommendations state that your A1C should be tested at least every
three months by your healthcare professional.
Introduction to pump therapy
15
Your healthcare professional will rely on the results of your blood glucose tests to make changes in your
pump settings. The results of your A1C tests are used to assess your overall blood glucose control.
If you are on pump therapy, you must test your BG at least:
•
•
•
•
•
Upon waking up
Before each meal
At bedtime
If you feel nauseous
One hour after any BG above 250 mg/dL (13.9 mmol/L)
Below are target guidelines from the American Diabetes Association for adults with diabetes. Consult your
healthcare professional to find out what your targets should be.
Summary of recommendations for adults with diabetes mellitus
Glycemic control A1C
<7.0 percent
Preprandial plasma glucose (before meals)
90-130 mg/dL (5.0-7.2 mmol/L)
Peak postprandial plasma glucose (1-2 hours after meals)
<180 mg/dL (<10.0 mmol/L)
Correlation between A1C level and blood glucose levels
Mean plasma glucose
16
A1C (percent)
mg/dL
mmol/L
6
135
7.5
7
170
9.5
8
205
11.5
9
240
13.5
10
275
15.5
11
310
17.5
Introduction to pump therapy
Correlation between A1C level and blood glucose levels
Mean plasma glucose
A1C (percent)
mg/dL
mmol/L
12
345
19.5
American Diabetes Association. Diabetes Care. “Tests of Glycemia in Diabetes.” &
“Standards of Medical Care.” Vol. 31, Supplement 1, January 2008. S18.
Low blood glucose (hypoglycemia)
•
•
•
•
not enough food
too much insulin
more exercise than usual
drinking alcoholic beverages
Chapter 2
Low blood glucose can occur while using the pump for the same reasons it can while using daily injections:
As you know, you cannot always avoid low blood glucose. It is important that you create a routine to
follow when your BG is low. If you have a routine, you will have something ready to treat a low BG. This
makes it less likely you will over-treat and cause your blood glucose to go up too much.
It is best to use something that you can always carry with you. Choose a food that is all carbohydrate
because it will be fast acting. Avoid using high fat foods such as chocolate. They will not work fast enough,
and you may also end up over-treating your lows. When treating hypoglycemia, start with 15 grams of fast
acting carbohydrates. Do not keep eating until you feel better. Eat the required amount and stop. The
feelings will pass and you will be grateful that you did not overdo it.
Some people with diabetes know when their blood glucose is low and some do not. If you are not aware of
hypoglycemia, it is important to test your blood glucose more often. Everyone with diabetes should test
before driving a car to assure safety on the road. Blood glucose should be above 100 mg/dL (5.6 mmol/L)
before driving and at bedtime.
Tip: We suggest that you use glucose tablets to treat a low. These tablets contain a known, premeasured amount of carbohydrate, and are in handy packages that you can carry in your pocket, purse, or
car.
Introduction to pump therapy
17
Hypoglycemia protocol: the rule of 15
Check with your healthcare professional for guidelines on treating your low BG. The following instructions
are commonly used to treat a BG that is 70 mg/dL (3.9 mmol/L) or lower:
1
2
3
4
18
Eat 15 grams of fast acting carbohydrate.
Check BG again in 15 minutes; if not above 70 mg/dL (3.9 mmol/L), repeat treatment.
Check BG again in 15 minutes; if still not above 70 mg/dL (3.9 mmol/L), repeat treatment again.
Contact your healthcare professional if your BG is still not above 70 mg/dL (3.9 mmol/L).
Introduction to pump therapy
These items have 15 grams of fast acting carbohydrates:
•
•
•
•
Glucose tablets (three, 5-gram tablets or four, 4-gram tablets)
4 oz. of juice or soda (not diet)
6-7 Life Savers® (hard candies)
1 tablespoon of table sugar or honey
High blood glucose (hyperglycemia)
High blood glucose can occur while using the pump for the same reasons it can while using daily injections:
Chapter 2
•
•
•
•
Too much food
Not enough insulin
Loss of insulin strength
Disruption of insulin delivery from the pump
The goal of treating hyperglycemia is to prevent Diabetic Ketoacidosis (DKA) and delay or prevent diabetes
problems due to high blood glucose over a lengthy period of time.
If for any reason you are not getting the proper amount of insulin, your blood glucose rises quickly. This
can occur with insulin pump therapy from the disruption of insulin delivery. This happens from the infusion
set coming out, clogs, or leaks, or insulin not being absorbed right.
Since the pump only delivers fast-acting insulin, hyperglycemia can occur rapidly. Your healthcare
professional will give you data needed for you to determine your correction bolus. This correction dose is
based on your insulin sensitivity.
It is vital that you know these guidelines in the hyperglycemia protocol.
Hyperglycemia protocol
If one blood glucose reading is above 250 mg/dL (13.9 mmol/L):
•
•
Take a correction bolus right away.
Test BG in one hour.
Introduction to pump therapy
19
If the second blood glucose is above 250 mg/dL (13.9 mmol/L):
•
•
•
•
•
•
Take an insulin injection by syringe (not through the pump). The amount should be the same as if you
were taking a correction bolus.
Change the entire infusion set system (new reservoir, infusion set, and cannula). Consider changing the
insulin vial if you believe that the insulin is no longer stable.
Check urine for ketones and call your healthcare professional if ketones are present.
Drink liquid with no calories every 30 minutes (for example: 8 oz. diet ginger ale, broth, water).
Test blood glucose every two hours and keep taking correction insulin until blood glucose reaches
target.
Call your healthcare professional if your blood glucose and urine ketones remain high or you are
unable to drink.
Treating hyperglycemia from illness or infection through insulin pump therapy will be discussed on the
following pages.
Diabetes ketoacidosis (DKA)
DKA results from untreated hyperglycemia. DKA is a serious medical problem that needs treatment right
away. The insulin pump therapy uses only fast-acting insulin, so DKA can occur rapidly if insulin delivery is
disrupted. It is important that you understand these guidelines.
Preventing DKA
If you have nausea or vomiting, immediately check your blood glucose and ketones. If your blood glucose is
above 250 mg/dL (13.9 mmol/L) and/or ketones are present:
•
•
•
•
•
•
•
20
Take an injection of fast-acting or regular-acting insulin with a syringe (not through the pump). The
amount should be the same as if you were taking a correction bolus. If ketones are present, more
insulin may be needed. Contact your healthcare professional for guidelines for insulin doses especially
when ketones are present.
Change the entire infusion set system (new reservoir, infusion set, and cannula). Consider changing the
insulin vial if you believe that the insulin is no longer stable.
Call your healthcare professional.
Troubleshoot the pump. If help is needed, please call our 24 Hour HelpLine for assistance.
Drink liquids with no calories every 30 minutes (for example: 8 oz. diet ginger ale, broth, water).
Check your blood glucose and ketones in one hour.
Continue to take insulin as discussed with your healthcare professional.
Introduction to pump therapy
•
•
•
Call your healthcare professional right away if your blood glucose and ketones are not decreasing, or
you cannot drink fluids.
Continue to test blood glucose and ketones. Continue to take correction insulin injections as told until
your blood glucose reaches your target level.
If your blood glucose is less than 200 mg/dL (11.1 mmol/L) and ketones are present, drink liquids with
calories. Some examples of caloric fluids are juice and non-diet soda. Also, extra insulin may be
needed. Contact your healthcare professional for guidelines for insulin doses when ketones are
present.
Tip:
Sick day management
Managing diabetes during an illness or infection requires frequent blood glucose and urine
ketone testing. Illness and infection put extra stress on the body and often raise blood
glucose. The insulin pump allows you to make changes. It lets you quickly and easily
respond to blood glucose changes due to illness and infection.
Chapter 2
You should have a meter, glucose strips, and ketones strips handy at all times. This way you are
always ready to test your blood glucose and ketones.
Even if you are not able to eat, you need insulin. Depending on blood glucose testing, you
may or may not need to adjust your basal insulin to cover your needs. You may also need
to take frequent correction boluses during illness.
Sick day protocol
•
•
•
•
•
•
Test your blood glucose every two hours, 24 hours a day.
Check urine ketones every time you urinate.
If you are throwing up and/or have ketones, you must call your healthcare professional. They will give
you the proper treatment with fluids and insulin to avoid DKA.
Consult your healthcare professional about taking more insulin if your blood glucose is 250 mg/dL
(13.9 mmol/L) or higher. Also take more insulin when ketones are fair or large.
Keep exact records of your blood glucose values, ketones, medication, temperature and all other
signs.
Keep in mind that you need more insulin and fluids when there are urine ketones. This is true even if
your blood glucose is within your target range.
Introduction to pump therapy
21
Sick day supplies
You should have the supplies listed below in the house at all times, and carry them with you when you
travel:
•
•
•
•
•
•
Fluids that have sugar (regular soda, juice, jello) to replace solid food.
Sugar-free liquids (diet drinks, bouillon, water) for replacing lost fluids.
Thermometer.
Sugar free medicine for fever, cough, congestion, nausea and vomiting.
Extra blood glucose and ketone strips.
Glucagon emergency kit in case of severe hypoglycemia. This can be used if you cannot eat or are
unconscious.
Caring for your diabetes when you are sick is worthwhile and can be a challenge. If you are too sick to
watch your diabetes carefully, ask a friend or family member to help. If there is no one to help you, ask
your healthcare professional for help.
Nutrition
Good nutrition and making healthy choices are important for everyone. Additionally, for those with
diabetes, it is more important to know the nutrient content in food, and how the nutrients affect blood
glucose.
Carbohydrates have the most effect on blood glucose, notably within a few hours of being eaten. Counting
carbohydrates allows you to match your insulin dose to the food you are eating. This is your insulin to
carbohydrate ratio. Although fat and protein can affect your blood glucose when eaten in large amounts,
carbohydrates affect blood glucose the most.
Consult with your healthcare professional for your personal nutritional guidelines.
Carbohydrate counting
With insulin pump therapy, you must take a bolus for the carbohydrates you eat. You need to count the
carbohydrates you plan to eat to see how much insulin to take.
There are two basic methods to count carbohydrates, and in truth, they are very much alike. Many people
use parts of both of the two methods.
22
Introduction to pump therapy
Carbohydrate gram counting
With this method, you add up the exact number of grams of carbohydrate in each meal. Food labels, food
list and meal planning books are great tools for carbohydrate gram counting.
Carbohydrate exchange system
This method uses food groups called exchange groups. One exchange with carbohydrate has about 15
grams of carbohydrate.
1 fruit exchange
1 milk exchange
15 grams carbohydrate
15 grams carbohydrate
12 to 15 grams carbohydrate
Foods with carbohydrates include:
•
•
•
•
starches and starchy vegetables
fruits and fruit juices
milk and milk products
sugars and foods with sugar
Chapter 2
1 bread exchange
Facts on the nutrition labels on packaged food will help you to figure how much carbohydrate is in a
certain food. There are a number of paperback books that list the grams of carbohydrates in many foods.
These books are very helpful when you are eating foods without labels or are eating out. Also, if you know
the exchange system, you can count carbohydrate exchanges.
Your healthcare professional will give you an insulin to carbohydrate ratio at the start. This will be a place
to begin. It may need to be changed based on the results of your blood glucose readings after you eat.
Determining your meal bolus based on carbohydrate counting is not an exact science. Sometimes it takes
trial and error to come up with the correct meal bolus for certain foods. If you are not sure how some
foods affect your blood glucose, test your blood glucose two hours after eating. If your reading is too high
or too low, adjust your meal bolus the next time you make that food choice.
As you start to learn carbohydrate counting, try to assess the carbohydrates in the food you are eating.
Then look at the food labels to see how close you are.
Reading a food label
Use the Serving Size and Total Carbohydrates information on the food label to determine how many total
grams of carbohydrate you will be eating. Then, use the insulin to carbohydrate ratio prescribed by your
healthcare professional. This allows you to figure out how much insulin to take for the foods you eat.
Introduction to pump therapy
23
The following food label shows 12 grams of carbohydrates for each 1 piece serving. If your carbohydrate
ratio is 1 unit of insulin for every 12 grams of carbohydrate, you would need 1 unit of insulin for each 1
piece serving of this food.
Nutrition Facts
Serving Size 1 piece (20g)
Serving per Container 22
Amount Per Serving:
Calories: 50
Fat Calories: 0
Total Fat 0g
Sodium 0g
Total Carbohydrates 12g
Sugars 11g
Protein 0g
Fat and blood glucose
Although fat does not have carbohydrate, it may affect your blood glucose level. Your blood glucose can be
normal two hours after a meal with high fat foods. However, four to six hours later your blood glucose will
increase. That is because the fat slows down the rate the carbohydrates are absorbed in that meal.
Foods with fat include:
•
margarine
•
oils
•
mayonnaise
•
salad dressing
•
nuts
•
fried foods
•
butter
•
sour cream
•
whole milk
•
cream cheese
•
bacon
•
high fat meats
Doctors and health experts suggest that all people, with or without diabetes, eat less total fat—namely
less saturated fat. If you have high cholesterol or are trying to lose weight, it is key to limit the amount of
fat you eat per day.
24
Introduction to pump therapy
There are bolus type options available on your pump that can be helpful in handling the rare high-fat
meal. Before using bolus type options, you should be at ease using basic pump features and consult with
your healthcare professional.
Protein and blood glucose
Protein has little effect on blood glucose when eaten in moderate amounts, and normally does not require
any insulin.
Sources of protein include:
meat
•
fish
•
poultry
•
eggs
•
cheese
•
peanut butter
•
tofu
•
dried beans
•
dried peas
Chapter 2
•
Protein needs are the same for people with and without diabetes, unless kidney disease is present. Most
people eat more protein than they need. Protein does not need to be part of every meal. In general,
140-200 grams of protein a day is enough. If you have high cholesterol or are trying to lose weight, eat
leaner proteins such as chicken and fish.
Other things that affect blood glucose
Fiber may slow down the rise in blood glucose after a meal. Fiber grams are not absorbed. They can be
subtracted from the Total Carbohydrate amount for foods or meals with more than 5 grams of fiber. Fiber
is an important part of a healthy diet. Suggestions for fiber intake are the same for people with and
without diabetes.
Sodium (salt) has no effect on blood glucose. Moderate sodium intake is suggested for people with or
without diabetes. If you have high blood pressure or are affected by sodium, limit the amount of sodium in
your diet.
Alcohol can cause low blood glucose by slowing down the release of glucose from the liver. This glucose
release keeps blood glucose in target between meals. Therefore, food should be eaten while having a
drink with alcohol. The carbohydrate content of different types of alcohol can be found in carbohydrate
counting books. Consult your healthcare professional for guidelines on bolusing for alcohol.
Vitamins and minerals have no effect on blood glucose.
Introduction to pump therapy
25
Healthy eating habits
Insulin pump therapy gives you the choice of when, what and how much to eat without impacting blood
glucose control. This gives you the flexibility to sleep-in, postpone or skip meals, and eat snacks—the same
as people who do not have diabetes. Be careful to not abuse this freedom and compromise your nutritional
health. All people need to make healthy food choices to be mentally and physically healthy.
It is not an exact science to figure your meal bolus based on carbohydrate counting. Sometimes it takes
trial and error to figure the correct meal bolus for certain foods. If you are unsure how certain foods will
affect your blood glucose, test your blood glucose two hours after you eat. Keep records of foods that you
eat on regular basis. Note the bolus amounts and post-prandial readings for each entry. If your reading is
too high or too low, adjust your meal bolus the next time you make that food choice.
Exercise
Your body needs insulin and carbohydrate to provide cells with energy during exercise. How much insulin
and carbohydrates you need varies with the types of exercise and with how often you exercise. Using an
insulin pump during exercise allows you to reduce your basal rate instead of eating extra carbohydrate.
Before, you needed to eat extra carbohydrate to make up for the glucose lowering effect exercise often
has on blood glucose. It takes trial and error to get the balance right.
The body needs insulin during exercise. Therefore, it is not suggested that you stop the pump unless the
exercise is for a short amount of time (one hour or less). If you need to remove the pump for more than
one hour, refer to the If you remove your pump section in The basics chapter.
If you do an exercise that on average lowers your blood glucose, you can use the temporary basal rate
feature. You can use this feature to lower the amount of insulin delivered and reduce the risk of
hypoglycemia. You may also choose to change your basal rate pattern for the days you exercise.
It takes a period of time to determine how much to adjust your basal rate during exercise. Record your
blood glucose before, during and after exercise to figure the proper reduction in your basal rate. Record
any carbohydrates that you have eaten during the exercise period. There is no magic formula that will tell
you just what to do. You have to test often to figure out the basal rate that you need during exercise.
26
Introduction to pump therapy
The basics
Your pump
CAUTION: Never use sharp objects to press the buttons on your Paradigm pump as this can damage the
buttons or compromise the seal of the pump. Some examples of sharp objects that may damage your
keypad are fingernail files, pens or pencils, paper clips, knives, scissors, and keys.
battery
compartment
tubing
connector
screen
ESC
reservoir
window
Chapter 3
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.
ACT
ESC
buttons
ACT
reservoir
compartment
The basics
27
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 prime 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
battery
the disposable requirements of your state or
country. Put the new battery in the pump with
battery cap
the negative end [(-) symbol] going in first.
Check the label on the back of the pump to
make sure the battery is inserted correctly.
NOTE:
Do not use batteries that have been in
cold storage, such as in the refrigerator or in your car during winter in cold climates.
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.
28
The basics
one half-turn
one half-turn
5
6
7
While the pump turns on, it will show one or more screens until
the HOME screen appears.
If the HOME screen does not appear, do these steps:
a. Check that the battery is inserted correctly. If the battery has
been installed backwards, remove the battery and install it
HOME screen
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 your local help line or representative.
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.
The buttons on the pump are used to navigate through the menus and screens, and to program the
features of the pump.
Chapter 3
Pump buttons
UP button
From the HOME
screen, this is the
EASY BOLUS button
EXPRESS
BOLUS
button
ESC
button
ACT
button
DOWN
button
The basics
29
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 3–hour sensor glucose graph.
•
2 presses open the 24–hour sensor glucose graph.
•
3 presses open the pump STATUS screen.
•
4 presses open the SENSOR STATUS screen.
EXPRESS BOLUS button—Shortcut to the SET BOLUS screen or the ENTER BG screen of Bolus
Wizard to set up 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.
30
The basics
Button
Description
•
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:
HOME screen
Chapter 3
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 your local
representative.
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.
The basics
31
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 you want to make sure you have a new battery
available.
At least 75% left
Low battery
Time display
The current time of day is displayed across the top of the pump screen in the
format you select—12-hour or 24-hour. The AM or PM is only displayed for
the 12-hour format. For instructions on setting the time on your pump, see
the Setting the time and date section in the Basic programming chapter.
24-Hr
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.
75 to 100% left
Less than 25% left
NOTE:
For the Paradigm 722/722K, your reservoir icon will only appear full if using a filled 300-unit
Paradigm reservoir. The icon will not appear full if you use the 176-unit Paradigm reservoir.
Alert and alarm icons
An open circle (alert) or a solid circle (alarm) are displayed in the upper part of
your pump screen only when there is an alert or alarm condition on your pump.
For alarm and alert information, see the Troubleshooting and alarms chapter.
32
The basics
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.
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.
When you press
from the HOME screen, the light on the screen turns on or off. During programming,
the backlight can be turned on by pressing the
and the
together. The light will stay on while you
Chapter 3
Screen backlight
are pressing any of the pump buttons. It will stay on as long as the current screen is active.
To conserve your battery, the backlight will turn off automatically while the pump is vibrating. After the
vibration is finished, the light will turn back on. The backlight cannot be turned on in a low or dead
battery condition.
Beep/vibrate
Your pump will beep or vibrate to indicate activity. Refer to the Setting your alert type section in the
Utilities chapter for setup instructions.
Operating modes
The screen lets you know when a special feature is active or if there is a condition that needs your
attention. The active features and pump status will determine the operating mode. The screens for the
three modes are shown in the following sections.
The basics
33
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
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.
34
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 and alarms chapter for alarm conditions that
will trigger the Attention mode. See the Stopping your pump section in the Basic programming chapter to
learn about Suspend mode.
Menus
The MAIN MENU is the highest level menu. There are submenus, functions, status and programming screens
in the lower menu levels. The menus are described in the following paragraphs.
Tip:
If a screen item is flashing (blinking), during programming, press
or
to change the value.
MAIN MENU
BOLUS MENU
Contains the settings and functions for bolus deliveries. The
Chapter 3
Highest menu level in the menu system. When you press ACT from the HOME screen, the MAIN MENU will
appear.
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.
BASAL MENU
Contains the functions to setup and deliver your basal. Refer to the Basal 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
35
PRIME MENU
Contains the functions to change your reservoir and fill the infusion set with insulin. Refer to the 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
•
To exit the STATUS screen, press ESC until the STATUS screen disappears.
or
to scroll and view all of the information.
The screen includes information about:
•
•
•
•
•
•
•
•
Recent bolus insulin delivery
Current basal insulin delivery
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.
36
The basics
If you remove your pump
You may have an occasion when you need or want to remove your pump. If you have to remove and store
your pump, it is recommended that you do the following:
•
•
•
Store your pump with the battery in place
Keep a record of your current basal rates and use the Save Settings feature (see the Saving the
settings section in the Utilities chapter).
To preserve battery life, reset the basal rates to 0 (zero), turn off the RF options (meter, remote), and
set Auto-off to dashes or zeroes.
Remember, your body still needs insulin while your pump is removed.
The basics
Chapter 3
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.
37
38
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).
1
Go to the TIME/DATE
SETUP screen.
ACT
Main > Utilities >
Time/Date
Select 12-Hour Setup or 24-Hour Setup and press ACT.
Press ACT again to change the settings.
Change each of the settings as follows:
a. Hour
Change the hour. Press ACT.
For 12-hour setups, press
or
Chapter 4
2
3
4
until the correct A (am)
or P (pm) appears.
b. Minutes
Change the minutes. Press ACT.
Basic programming
39
c. Year
Change the year. Press ACT.
d. Month
Change the month. Press ACT.
e. Day
Change the day. Press ACT.
5
The TIME SET AT screen will show the settings that you
programmed. Press ACT and exit the menus.
Your time/date settings are complete.
Selecting the language
The language shown on the pump screens can be changed. Some languages may not be available on all
pumps. Before you can select another language, you need to set the time using the English screens. Refer
to the previous section.
To change the language for your pump:
1
Go to the LANGUAGE
MENU screen.
Main > Utilities >
Language
2
3
40
Select your language, then press ACT.
The language setting is now changed. Exit the menus.
Basic programming
ACT
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.)
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
You can also use the
2
3
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.
Chapter 4
Select Set Bolus and press ACT. Go to step 2.
NOTE:
If you have BG Reminder turned On, a BG REMINDER DURATION screen displays. It allows you
to set the length of time after this bolus before you are reminded to check your blood glucose. See
the BG Reminder section in this chapter for information about this feature.
4
The BOLUS DELIVERY screen appears and the Normal bolus starts. The pump will beep/vibrate at the
start of the bolus. As the bolus delivers, the amount shown on the screen will increase until the entire
bolus has been delivered. When the bolus is finished, the pump will beep/vibrate again and the HOME
screen will appear.
The following practice lessons will help you understand this pump feature.
Basic programming
41
Normal meal bolus using the exchange system
Normal bolus can be used to cover the carbohydrate in a meal or snack and to correct a blood glucose
that is higher than the target that was chosen for you.
Fred has been taught that he needs to take 1 unit of insulin for every carbohydrate exchange that he
eats (every milk, every starch or every fruit). For lunch today he will eat:
Turkey sandwich with two slices of bread
2 starches
1 small apple
1 fruit
1 cup of non-fat milk
1 milk
__________________
Total carbohydrate exchanges =
4
Fred's lunch has a total of 4 carbohydrate exchanges so he will take a meal bolus of 4 units for his lunch.
Bolus practice:
NOTE:
Make sure that you are not connected to your pump while
practicing.
Going through the menus, program a 2.0 unit Normal bolus now.
Check here if you were able to program it.
Using the express bolus button
, program a 2.0 unit Normal bolus now.
Check here if you were able to program it.
42
Basic programming
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:
0 grams
2/3 cup of rice
30 grams
1/2 cooked broccoli
5 grams
1 ounce dinner roll
15 grams
1 tsp margarine
0 grams
Chapter 4
4 ounces broiled chicken
__________________
total grams of carbohydrates =
50 grams
Lydia's dinner totals 50 grams of carbohydrate. Her insulin to carbohydrate ratio is 1 unit: 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).
Basic programming
43
Choose a meal you might eat and fill in the blanks.
Food:__________
grams of carbohydrate:____________
__________
grams of carbohydrate:____________
__________
grams of carbohydrate:____________
total grams of carbohydrate:____________
Your insulin to carbohydrate ratio: 1 unit of insulin for _______ grams carbohydrate.
Divide your total carbohydrates by your insulin to carbohydrate ratio and take _____ units of insulin for
your meal.
Meal bolus, correction bolus and insulin sensitivity
Jason is ready to eat his breakfast. He has calculated that he will need 4.0 units for his food.
He tests his blood glucose and finds that it is 200 mg/dL (11.1 mmol/L). Jason knows that his blood
glucose level is above his blood glucose target and will need additional insulin before he eats.
Jason's healthcare professional has determined the following for him:
Target BG: 110 mg/dL (6.1 mmol/L)
Insulin sensitivity1: 36 mg/dL (2.0 mmol/L)
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 (insulin sensitivity) (5.0 / 2.0 mmol/L) = 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 mmol/L or mg/dL) by which blood glucose will be lowered after taking 1 unit of
insulin. Consult with your healthcare professional to determine your insulin sensitivity.
44
Basic programming
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.
Chapter 4
Basic programming
45
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 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.
(with the Bolus Wizard feature)
Main > Bolus > Bolus
History
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.
2
46
date
carb value
BG value
time
amount/type
N = Normal
S = Square Wave
DN = Normal part of dual wave bolus
DS = Square part of dual wave bolus
Refer to the instructions in the Bolus details section, to see the details for any of these boluses.
Basic programming
Bolus details
You can view the details of any of the deliveries in the BOLUS HISTORY screen. The details include:
•
•
•
•
bolus types: normal, square, and dual
programmed bolus amount
delivered bolus amount
Bolus Wizard feature information (if used)
To see the details of any bolus, do these steps:
1
In the BOLUS HISTORY
screen, select the bolus
that you want to review
and press ACT.
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 completed
2
3
Chapter 4
delivery stopped
Press the down key to see the
details
The details for that bolus will appear on the screen. Scroll through the details.
Exit when you are done.
Basic programming
47
Maximum bolus limit
The Maximum bolus (Max bolus) is a safety feature that limits the amount of insulin that can be delivered
in a single bolus. The factory setting is 10.0 units. You can specify the limit from 0.0 to 25.0 units. It is
important to discuss this feature with your healthcare professional to determine your Max bolus amount.
To set the Maximum bolus limit, do these steps:
1
Go to the MAX BOLUS SETUP screen.
2
3
Main > Bolus > Max Bolus
Set your maximum bolus limit and press ACT.
Your Max bolus is set. Exit the menus.
Example 1: Max bolus
Shelby takes very small doses of insulin for her meal boluses. As a safety limit, she and her healthcare
professional reset her pump with a Maximum bolus of 5.0 units.
Example 2: Max bolus
David is a growing teenager. He loves to eat big meals and requires very large doses of insulin for his
food. He reset his pump with a maximum bolus of 20.0 units so he can take more insulin when he needs
to.
48
Basic programming
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
Go to the BG REMINDER SETUP screen.
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.
Chapter 4
Main > Bolus > 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.
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,
in minutes and hours, before the reminder goes off.
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
49
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 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
3:00 AM
Basal Rate 2
start time
rate 1
rate 4
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 3:00 a.m. (3:00) for basal rate 1
3:00 a.m. (3:00) to 7:00 a.m. (7:00) for basal rate 2
7:00 a.m. (7:00) to 9:00 p.m. (21:00 ) for basal rate 3
9:00 p.m. (21:00 ) to 12:00 a.m (00:00) 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 3:00 a.m (21:00 to 3:00) at one rate. Basal rate 1 always
starts at midnight and should be set to end at 3:00 a.m. (3:00 ). After setting basal rates 2 and 3, rate 4 is
set from 9:00 p.m. (21:00) to midnight at the same rate as basal rate 1. This gives continuous basal insulin
from 9:00 p.m to 3:00 a.m. (21:00 to 3:00) 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.
50
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, i.e. more than a day, set the basal rate
to 0.00 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 The basics chapter for more information.
Basal programming and delivery
NOTE:
You cannot make changes to your basal rate settings while a percent temp basal is active.
To set your basal rates:
2
3
4
5
6
7
8
9
Go to the SET BASAL RATE 1 screen.
Main > Basal > Set/Edit Basal
The SET BASAL RATE 1 screen flashes the basal rate in U/H.
Enter your first basal rate amount and press ACT.
The start time for your first basal rate is midnight and cannot be changed.
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.
In the SET START TIME 2 screen, enter the start time for the next rate.
Press ACT. The SET BASAL RATE 2 screen appears. Enter the rate.
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.
After you program your last basal rate, press ESC.
The BASAL RATE screen appears. Your basal rate(s) will now deliver as programmed. Exit the menus.
Basic programming
Chapter 4
1
51
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
current basal
The STATUS screen shows your current basal information.
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
2
3
Go to the BASAL MENU screen.
Main > Basal
Select Basal Review and press ACT.
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
52
Basic programming
(24-hour total)
basal insulin
basal rate
start times
basal
delivery rates
Chapter 4
Basic programming
53
4
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.
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 2.0 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.
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 > 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 0.4 units per hour. As a safety
measure, Helen's healthcare professional set her pump with a Maximum basal rate of 1.0 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 2.0 units per hour, but he needs 2.8 units per hour in the
early morning. Rusty will reprogram his Maximum basal to 3.0 units per hour to accommodate his needs.
54
Basic programming
Stopping your pump
Suspend stops all insulin delivery including the current basal and any bolus or prime 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 a.m. The pump will beep or vibrate at 11:30 a.m.,
11:45 a.m., 12:00 noon, and so on until you resume your pump (basal resumes).
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. No other functions are available.
To suspend the pump:
1
2
3
Select Suspend from the MAIN MENU, and press ACT.
Resume pump delivery
Chapter 4
Main > Suspend
SUSPEND will flash on your screen. Press ACT to stop your pump.
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.
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.
NOTE:
A bolus or fixed prime that was stopped by suspend will not restart when you resume your
pump. You must reprogram and activate it to finish delivery.
Basic programming
55
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.
1 Give a 3.0 unit bolus now. While it is delivering, suspend the bolus.
2 Check here if you were able to suspend the bolus.
3
4
56
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.
Prepare your pump for use
We recommend that you watch the training CD-ROM enclosed with your pump, and complete your pump
start training, before continuing with the steps in this chapter.
When you are done practicing and ready to use your pump with insulin, you must make sure the time and
date are correct on your pump. You must also program your settings as instructed by your healthcare
professional.
You will need these items:
•
•
•
•
Pump
Insulin (U100)
Paradigm reservoir and user guide
Paradigm compatible infusion set and user guide
Chapter 5
Starting on insulin
57
Filling the reservoir
Warning: Do not use the reservoir or infusion set if any liquid gets on the top of the reservoir or inside
the tubing connector (as shown in the image). Liquid can temporarily block the vents. This may result
in the delivery of too little or too much insulin, which can cause hypoglycemia or hyperglycemia. If
any liquid gets on the top of the reservoir or inside the tubing connector, start over with a new
reservoir and infusion set.
Top of
reservoir
Tubing
connector
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.
CAUTION: Insulin comes in different vial types, depending on your country. If your vial is different
than the one described in the User Guide, consult with your healthcare professional on how to fill
your reservoir.
1
2
3
58
Remove reservoir from package. Make sure plunger rod is fully extended.
Swab vial with alcohol (not shown).
Making sure you do not push down on the plunger, press the transfer guard onto the vial.
Starting on insulin
1
plunger
rod
3
reservoir
transfer
guard
4
5
6
vial
Push down on the plunger to pressurize the vial. Hold down the plunger rod.
While still holding the plunger rod, flip the vial over so the vial is on top, slowly pull down on the
plunger to fill the reservoir.
Gently tap the side of the reservoir to make any air bubbles rise to the top of the reservoir.
Slowly push up on the plunger just enough to remove any air bubbles from the reservoir.
Slowly pull down on the plunger to fill the reservoir to the number of units desired.
To avoid getting liquid on the top of the reservoir, flip the vial over so that it is upright. Turn the
reservoir counter-clockwise, then pull straight up to remove the reservoir 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.
Starting on insulin
Chapter 5
7
8
9
59
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.
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
2
60
Remove the entire infusion set from your body.
If attached, remove the activity guard.
Starting on insulin
3
Turn the tubing connector half-turn counter
clockwise, then pull the reservoir and connector
out from the pump.
4
5
Safely dispose of the used reservoir and infusion set item in a sharp's container.
You must now rewind your pump as described in the next section.
tubing connector
half-turn counter-clockwise
Chapter 5
Starting on insulin
61
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.
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 > Prime > Rewind
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 PREPARING TO PRIME 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 manual prime instructions described in the Manual prime
section of this chapter.
If you are not practicing, continue to the next section to insert the reservoir in your pump.
Inserting the reservoir in your pump
If your reservoir is already inserted in your pump, continue to the next section.
You must do these steps in the order described. If you are practicing, do NOT insert the reservoir in your
pump.
CAUTION: You must rewind your pump before installing a new reservoir. As part of the pump's
function, it calculates the reservoir volume. To ensure correct volume calculations, your pump has
been designed to require a rewind before you insert your reservoir.
1
62
If you are using the pump for the first time, remove the red shipping cap from the reservoir
compartment.
Starting on insulin
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.
3
Turn the tubing connector approximately 1/2 -turn clockwise until the connector is seated. The tubing
connector should be aligned horizontally with the pump case as shown here.
tubing connector
Chapter 5
4
5
Attach the activity guard, if desired.
You must now do a manual prime as described in the next section.
Starting on insulin
63
Manual prime
Manual prime fills the infusion set tubing with insulin before you insert the set into the body. Manual prime
is only available after you rewind your pump.
WARNING: Make sure that the infusion set is disconnected from your body before you press ACT to
prime the pump. 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
4
After you rewind your pump, the PREPARING TO PRIME screen appears.
The pump may automatically return to the HOME screen while you install the reservoir. Press ACT to
return to the PREPARING TO PRIME screen.
Press and hold ACT to start the prime. The pump will beep six times when the prime starts.
While you hold ACT, the pump will again beep six times when the screen begins counting the prime
units being used.
Continue to hold ACT until insulin droplets form on the tip of the infusion set needle, then release.
Make sure there are no bubbles in the tubing.
WARNING: If the PRIMING-HOLD ACT screen does not display, do NOT insert the infusion set in
your body. Please contact your local representative for assistance.
5
6
64
If your manual prime uses more than 30U insulin, the pump will show the following screen: IS PRIMING
COMPLETE? When you get this message, do the following:
a. Make sure you are not connected to the pump.
b. Read the message on the screen, then press ESC, ACT to clear.
c. If your manual prime is complete (you see droplets on the tip of the infusion set needle), press
ESC and continue to step 5.
Press ESC. Your manual prime is complete.
You can now insert the infusion set into your body as described in the next section.
Starting on insulin
Inserting the infusion set
WARNING: While the infusion set is connected to your body, do not unscrew and retighten the tubing
connector on the reservoir.
After you complete all of the following, you will be ready to insert the infusion set into your body:
•
•
•
•
fill your reservoir
rewind your pump
insert the reservoir into pump
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.
For maximum effectiveness, use the following two commonly used
methods:
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.
Chapter 5
•
Medtronic Diabetes offers a number of different infusion sets for your pump. Instructions for the Quickset® 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 Fixed prime section in this chapter to prime your pump.
Starting on insulin
65
Quick-set infusion set (with Quick-serter®)
Always refer to the instructions that shipped with your infusion set.
66
Starting on insulin
Fixed prime
A fixed prime fills the soft cannula with insulin and is required after the infusion set is inserted into your
body and the introducer needle removed. The prime amount depends on your infusion set type, so read
your infusion set instructions for the fixed prime amount.
1
Go to the PRIME MENU screen.
2
3
4
Main > Prime
Select Fixed Prime and press ACT.
In the FIXED PRIME screen, enter the insulin amount for your infusion set type, then press ACT.
After the prime begins, the PRIME DELIVERY screen will count the units as they are delivered. The
pump will beep after priming is complete.
Prime history
Do these steps to see a list of the delivered primes.
1
2
Go to the PRIME HISTORY.
Main > Prime > Prime History
Scroll through the list of prime deliveries. The letter F at the end of the text line indicates a fixed
prime.
The letter M indicates a manual prime. Exit the menus.
The Quick-set allows you the freedom to temporarily disconnect from your pump without removing the
infusion set from your body.
1
2
3
Chapter 5
Disconnecting Quick-set
Hold the side grips of the connector part with your fingers.
Twist the connector counter-clockwise.
Remove the connector from the site.
Starting on insulin
67
Reconnecting Quick-set
A fixed prime is used before reconnecting the infusion set to your body to ensure that insulin has filled the
infusion set. See the instructions in this chapter.
Place the connector part (flat side facing down) on the infusion site until it is fully seated. Do not grip the
connector part by the flat-side grips.
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.
68
Starting on insulin
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 a.m. - 3:00 a.m.)
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.
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.
Starting on insulin
Chapter 5
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.
69
70
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
Meter
Chapter 6
You need to know your blood glucose (BG) reading. When
using the Bolus Wizard feature, the pump can work with blood
glucose meter powered by MWT1 technology to automatically
receive your blood glucose reading. MWT1 is the wireless
Radio Frequency (RF) technology that is used to transmit
information from the meter to the pump. You can program
your pump to automatically receive your BG reading from this
meter. All meters referenced in this user guide are blood
glucose meters supported by MWT1 technology. The Meter
option section in this chapter has more information. If you are
not using this meter, you will manually enter your blood
glucose.
Using the Bolus Wizard feature
71
Your personal Bolus Wizard feature settings
In addition to your blood glucose reading and/or your food entry, the Bolus Wizard feature uses personal
settings that you program into the pump. (For instructions see the How to program the Bolus Wizard
feature section in this chapter.)
•
•
•
•
•
•
carb units (grams or exchanges)
carb ratios (in carbohydrate grams/unit of insulin or insulin units/carb exchanges)
BG units (mmol/L or mg/dL)
insulin sensitivity
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:
72
Using the Bolus Wizard feature
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.
#3: __________
(additional settings, if
needed)
range: 3 - 150 grams/unit
#4: __________
If you count exchanges:
this ratio is the amount of insulin you need to cover one
(carb) exchange.
#5: __________
range: 0.1 - 5.0 units/exchange
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)
#2: __________
start time
(midnight)
#6: __________
#7: __________
#8: __________
_____ mg/dL or _____ mmol/L
Chapter 6
Using the Bolus Wizard feature
73
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 or 0.5 - 22.2 mmol/L
#2: __________
NOTE:
#3: __________
(additional settings, if
needed)
Your insulin sensitivity may vary throughout the
day. Your pump allows you to program up to eight different
insulin sensitivities.
start time
(midnight)
#4: __________
#5: __________
#6: __________
#7: __________
#8: __________
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: __________
#3: __________
(additional settings, if
needed)
#6: __________
#7: __________
74
Using the Bolus Wizard feature
(midnight)
Bolus Wizard feature settings
Information
Setting
#8: __________
Bolus Wizard feature settings
Information
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.
Setting
Number of Hours: _____
range: 2-8 hours
How the Bolus Wizard feature works
1
If you want your current blood glucose to be factored in, enter your BG Reading.
• automatically from the meter (refer to the Meter option section in this chapter), or
• manually by selecting the
button.
2
3
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.
Bolus Wizard warnings
HIGH BG
Chapter 6
When using the Bolus Wizard feature, the pump may display a HIGH BG, LOW BG, and MAX BOLUS
EXCEEDED warnings.
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.
Using the Bolus Wizard feature
75
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
2
3
4
5
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 Wizard Setup > Edit Settings
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.
76
Using the Bolus Wizard feature
Turning on the Bolus Wizard feature
1
Go to the EDIT SETTINGS screen.
2
3
4
Main > Bolus > 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).
Any time you make changes to the carb units, you must also reprogram the carb ratios. Refer to the Bolus
Wizard feature settings table in this chapter for your carb ratio settings.
1
Make sure the EDIT SETTINGS screen is open.
2
3
4
Main > Bolus > 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.
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.
1
Chapter 6
To set the Carb/Exch ratios:
Make sure the EDIT SETTINGS screen is open.
Main > Bolus > Bolus Wizard Setup > Edit Settings
Using the Bolus Wizard feature
77
2
Select Carb Ratios, then press ACT.
• If you use grams as your carb units: Carb ratio is the number of carb grams that are covered by
one (1.0) unit of insulin.
• If you use exchanges as your carb units: Carb ratio is the number of insulin units that are needed
to cover one (1.0) carb exchange.
3 The SET CARB RATIO 1 (if you are using grams) or SET EXCH RATIO 1 (if using exchanges) screen
appears. The default ratio flashes on the screen.
4 Set your first ratio, then press ACT. Carb ratio values are normally between 5-50 grams/u or 0.3-3.0
u/exch. If your ratio value is outside the range, a warning message will appear on the screen. This
message warns that the entered carb ratio is valid but outside the usual range. Press ESC to correct or
ACT to continue.
The start time for your first ratio is midnight and cannot be changed.
5 The SET START TIME 2 screen appears. The dashes under the screen name flash. The first Carb Ratio or
Exchange Ratio is now set.
If you do not need a second ratio, press ESC and skip to the next section. If you need to set up another
ratio, follow steps 6 through 9.
6 In the SET START TIME 2 screen, enter the time of the day you want this ratio to become active.
7 Press ACT. The SET CARB RATIO 2 screen (if using grams) or SET EXCH RATIO 2 screen (if using
exchanges) appears.
8 The default ratio flashes. Select your ratio.
9 Press ACT. The SET START TIME 3 screen appears. The second carb or exchange ratio is now set.
10 If you do not need to set up any more ratios, press ESC. If you need to set up more ratios, repeat steps
6 through 9 above for each ratio.
You are now ready to set up the BG units.
Setting the BG units
You can select mmol/L or mg/dL as your Blood Glucose Unit (measurement type). If you make changes to
your BG settings, you must reprogram your insulin sensitivity and BG targets.
78
1
Make sure the EDIT SETTINGS screen is open.
2
3
4
Main > Bolus > 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.
Using the Bolus Wizard feature
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 (1.1 - 5.6 mmol/L). If your value is outside
this range, a warning message will appear on the screen.
1
Make sure the EDIT SETTINGS screen is open.
Using the Bolus Wizard feature
Chapter 6
Main > Bolus > Bolus Wizard Setup > Edit Settings
2 Select Sensitivity, then press ACT.
3 The INS SENSITIVITY 1 screen appears. The default sensitivity value flashes on the screen.
4 Set the value for your first insulin sensitivity setting, then press ACT.
The start time for your first insulin sensitivity is midnight and cannot be changed.
5 The SET START TIME 2 screen appears. The dashes under the screen name flash. The first insulin
sensitivity is now set.
If you do not need a second insulin sensitivity, press ESC and skip to the next section. If you need to
set up another insulin sensitivity, follow steps 6 through 9.
6 In the SET START TIME 2 screen enter the time of the day you want this insulin sensitivity to become
active.
7 Press ACT. The INS SENSITIVITY 2 screen appears.
8 The default sensitivity value flashes. Select the value for this insulin sensitivity.
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.
79
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.
Glucose Concentration
Setting the BG Targets
mmol/L
22.2
mg/dL
400
13.9
250
5.6
100
3.8
70
Correct down to the upper
limit of 100 mg/dL
If your current BG is above the BG Target
Correct up to the lower limit
range, the Bolus Wizard feature may
of 70 mgl/dL
calculate a correction dose. A correction
Target Range
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.
Pumps are sent from the factory with default BG target range of 100-100 mg/dL (5.6-5.6 mmol/L).
1
2
3
4
5
6
80
Make sure the EDIT SETTINGS screen is open.
Main > Bolus > 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 you adjust your BG Targets 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.
Using the Bolus Wizard feature
7
In the SET START TIME 2 screen enter the time of the day you want this BG Target range to become
active.
8 Press ACT. The TARGET RANGE 2 screen appears.
9 The low end of your BG Target range flashes on the screen. Set the BG Target, then press ACT.
10 The high end of your BG Target range flashes on the screen. Enter the BG Target, then press ACT.
11 The SET START TIME 3 screen appears. The second BG Target range is now set.
12 If you do not need to set up any more BG Target ranges, press ESC. If you need to set up more BG
Target ranges, repeat steps 7 through 11 above for each one.
You are now ready to set up the Active insulin time.
About active insulin
Active insulin is the bolus insulin that has already been delivered to your body, but has not yet been used.
The pump considers your active insulin time setting in determining any active insulin still in your body
from prior boluses. This may help prevent hypoglycemia caused by over-correcting for high blood glucose.
The Bolus Wizard feature automatically tracks active insulin for you, based on your active insulin time,
and subtracts the appropriate amount when your blood glucose is above your target range. The details will
appear in the ESTIMATE DETAILS screen during the bolus programming steps.
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.
Using the Bolus Wizard feature
Chapter 6
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.
81
Active insulin time
The active insulin time setting lets the pump know which active insulin time to use in calculating the
amount of active insulin to subtract before estimating a bolus. Your healthcare professional should
determine the active insulin time that is best for you.
To set the Active insulin time, do the following steps:
1
Make sure the EDIT SETTINGS screen is open.
2
3
4
5
Main > Bolus > Bolus Wizard Setup > Edit Settings
Select Active Ins Time, then press ACT.
The ACTIVE INS TIME screen appears. The default time of six 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
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.
82
1
Go to the REVIEW SETTINGS screen.
2
3
Main > Bolus > 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
Meter option
Paradigm Link™ and OneTouch® UltraLink™ glucose meters can
be programmed to communicate wirelessly to the Paradigm®
insulin pump. When the wireless feature is turned on, glucose
values transmitted from these meters to the pump are stored
in memory and used for glucose sensor calibration.
Your monitor is set at the factory with the meter option
turned off. If you have turned your meter option on, you
should turn off the wireless feature when using your glucose
sensor. By doing so, you can manually enter calibration
glucose values when glucose is stable and not changing
rapidly.
BG readings
Meter
Instructions for turning the wireless feature OFF are outlined below.
•
•
•
From the MAIN MENU, select UTILITIES and press ACT
Scroll to METER OPTION and press ACT
Select OFF and press ACT
You can set up your pump to automatically receive your blood glucose reading from a LifeScan OneTouch®
UltraLink™ Meter or the BD Paradigm Link® Meter. This meter may not be available in all countries.
Programming your meter ID links your pump to the meter. If you do not link the meter to your pump, you
will enter your blood glucose readings manually. Each meter has its own unique ID. You can link up to
three meters to your pump.
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.
NOTE:
The use of RF (radio frequency) devices with the pump reduces pump battery life.
Using the Bolus Wizard feature
Chapter 6
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 the serial number printed on the back of the meter. See the user guide that came with
your meter for detailed information on how to use it.
83
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.)
Add, delete, review meter IDs
The meter programming screens are very similar to those for the remote control. Make sure to select
Meter Options in the UTILITIES MENU screen when programming your meter.
If you are not sure that your meter ID is entered in your pump, check the REVIEW METER ID screen.
You have to turn on the meter option to add, delete, or review the meter ID(s) programmed in your pump.
1
2
3
84
Go to the METER OPTION screen.
Main > Utilities > Meter Options
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.
Using the Bolus Wizard feature
4
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
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.
Normal bolus using Bolus Wizard feature
After the Bolus Wizard feature is turned on and programmed, this feature can calculate an estimate of
insulin you need for your correction bolus and/or your food bolus. You have the option of using the
estimate or changing it as necessary. Additionally, your pump can receive your blood glucose reading from
the meter, if they are linked.
Use the
button to deliver a Normal bolus at any time except during another Normal bolus. A Normal
bolus will temporarily interrupt a Square Wave or Dual Wave bolus that is delivering. After the Normal
bolus is finished, the Square Wave or Dual Wave bolus delivery will resume.
NOTE:
If you want to use the pump-to-meter link, make sure the meter option is on. Refer to the
Meter option section in this chapter for instructions.
1
If you want a correction bolus, check your blood glucose with your blood glucose meter and go to step
2. If you want to bolus for food, go to step 2.
2
Press
3
The ENTER BG screen will appear.
a. If you are not using the meter:
Enter your blood glucose value. Press ACT and continue to step 4. If you are not entering a blood
glucose and want to bolus for food, select the dashes in the ENTER BG screen. The Bolus Wizard
feature will calculate the insulin needed for your food entry without considering your blood
glucose level. Press ACT and continue to step 4.
b. If you are using the meter, you must program your bolus within 12 minutes of the pump receiving
the reading from the meter. If more than 12 minutes have passed, the reading will no longer be
available from the screen and you must enter your blood glucose manually.
on your pump, or go to the BOLUS MENU, select Use Bolus Wizard, and press ACT.
Chapter 6
Using the Bolus Wizard feature
85
4
5
6
Your pump checks if the entered BG is within your target range. Press ACT to accept the Blood
glucose value. You can change this blood glucose value, if necessary, then press ACT. Continue to
step 4.
The ENTER FOOD screen appears.
a. If this is a food bolus, enter the food value you will eat, then press ACT.
b. If this is a correction bolus, select 0 (zero) as the value, then press ACT.
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
The BOLUS DELIVERY screen appears. The pump will beep or vibrate at the start and end of the bolus.
As the bolus is delivered, the screen shows the bolus type and amount until the total units have been
delivered. The screen then returns to the HOME screen.
Bolus Wizard feature examples
For the scenarios that follow, Michael has his Bolus Wizard feature turned on with the following settings:
Carb ratio: 15 grams per unit of insulin
Insulin Sensitivity: 40 mg/dL (2.2 mmol/L) per unit of
insulin
BG Target: 90 - 120 mg/dL (5.0 - 6.6 mmol/L)
Active Insulin Time: 6 hours
NOTE:
If you want to see details of the formulas the Bolus Wizard feature uses to calculate estimate
boluses like the ones in the following examples, see the Bolus Wizard feature specifications section in the
Pump specifications chapter.
86
Using the Bolus Wizard feature
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 6.6 mmol/L (120
mg/dL) is automatically sent to his pump.
He estimates that his meal consists of 60 grams of carbohydrates. When prompted by the Bolus Wizard
feature, he enters this amount in the ENTER FOOD screen. Based on his Bolus Wizard feature settings,
the pump will suggest that he take 4.0 units of insulin.
(food estimate)
60 g
15 g/u
(correction estimate)
= 4 units
Correction is 0 because the
current blood glucose reading
is within the BG Target Range.
+
bolus estimate
=4+0
= 4 units
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)
= 4 units
+
bolus estimate
11.1 mmol/L - 6.6 mmol/L
2.2 mmol/L/u
= 2 units
200 mg/dL - 120 mg/dL
40 mg/dL/u
= 2 units
Chapter 6
60 g
15 g/u
(correction estimate)
=4+2
= 6 units
Using the Bolus Wizard feature
87
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 to be at 70 mg/dL (3.9 mmol/L), which is below his Low BG Target of v (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)
60 g
15 g/u
(correction estimate)
= 4 units
+
bolus estimate
3.9 mmol/L - 5.0 mmol/L
2.2 mmol/L/u
= -0.5 units
70 mg/dL - 90 mg/dL
40 mg/dL/u
= -0.5 units
= 4 + (-0.5)
= 3.5 units
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 to to be 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)
60 g
15 g/u
= 4 units
(correction estimate)
+
11.1 mmol/L - 6.6 mmol/L
- 1.5 units (active insulin) = 0.5 units
2.2 mmol/L/u
200 mg/dL - 120 mg/dL
40 mg/dL/u
bolus estimate
88
Using the Bolus Wizard feature
= 4 + 0.5
= 4.5 units
- 1.5 units (active insulin) = 0.5 units
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 to be 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)
60 g
15 g/u
= 4 units
(correction estimate)
+
3.9 mmol/L - 5.0 mmol/L
- 0* units (active insulin) = 0.5 units
2.2 mmol/L/u
70 mg/dL - 90 mg/dL
40 mg/dL/u
bolus estimate
- 0* units (active insulin) = 0.5 units
= 4 + (-0.5)
= 3.5 units
NOTE:
*When the current blood glucose is below the target low blood glucose, the active insulin
amount is not considered in the Bolus Wizard feature calculations.
Chapter 6
Using the Bolus Wizard feature
89
90
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, disable or deliver Dual and Square Wave boluses, rewind or do a fixed
prime, 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 7
Optimizing pump therapy
91
See the following graphic for a description of the different bolus types:
Entire bolus amount
delivered immediately.
INSULIN
NORMAL
BOLUS
Bolus amount delivered evenly
over specified time period.
DUAL WAVE
BOLUS
SQUARE WAVE
BOLUS
2
1
Part of the bolus amount delivered
immediately and the remainder
delivered evenly over time period.
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 > 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.
Press
on your pump, or follow this path:
Main > Bolus > Set Bolus
92
Optimizing pump therapy
4
For a Square Wave bolus, do these steps:
a. Select Square Wave Bolus, then press ACT. The SET SQUARE BOLUS screen appears.
b. Enter the desired amount for the Square Wave bolus units, then press ACT.
c. Continue to step 5.
For a Dual Wave bolus, do these steps:
a. Select Dual Wave Bolus, then press ACT. The SET DUAL BOLUS TOTAL screen appears.
b. 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
5
6
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.
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.
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 7
Optimizing pump therapy
93
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.
94
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.
Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus
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.
The Bolus Wizard feature must be turned on and the settings must be programmed (see the How to
program the Bolus Wizard feature section of 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 of this chapter).
Optimizing pump therapy
Chapter 7
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.
95
1
Go to the ENTER BG screen.
Press
2
3
4
5
6
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 suggested portions. You can also press
7
96
or
to change these portions, then press
ACT.
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.
The SQUARE DURATION screen appears. Enter the amount of time you want the Square Wave bolus to
last, then press ACT.
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.
Optimizing pump therapy
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 pre-set 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 on. If you do not want to use Easy Bolus, turn it off.
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
time you press
for 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.
Easy bolus setup
1
Go to the EASY BOLUS OPTION screen.
Main > Bolus > Easy Bolus
Select On/Set, then press ACT. If you do not want to use Easy Bolus, select Off and press ACT.
NOTE:
If you are using the remote control, the Easy Bolus must be set to on.
Step value setup
Optimizing pump therapy
Chapter 7
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.
97
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
. The SET EASY BOLUS screen appears with the single step value
flashing.
2
Press
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
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.
98
press.
Optimizing pump therapy
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. Alex 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
, the pump will sound a different tone so he can keep track of
HOME screen, with each press of the
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.
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.)
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.
How many units did you give? _______
Your step level is ________.
How many tones did you count? _______
Optimizing pump therapy
Chapter 7
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.
99
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:
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.
•
•
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.
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 > 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 > Set/Edit Basal
100
Optimizing pump therapy
2
3
Select the basal pattern you want to program, then press ACT.
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.
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.
Chapter 7
Optimizing pump therapy
101
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.
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.
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.
102
Optimizing pump therapy
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.
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.
Chapter 7
Optimizing pump therapy
103
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)
3:00 p.m.
(15:00)
5:05 p.m.
(17:05)
104
Optimizing pump therapy
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 06:00 a.m. 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: 00:00
1.50 U/H
Segment #2: 11:00
1.60 U/H (largest)
Segment #3: 16:00
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.
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).
NOTE: The pump delivers basal amounts in 0.05 U/H increments. Because of this, your temp basal
amount will be rounded down to the next 0.05 U/H increment.
Chapter 7
Optimizing pump therapy
105
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)
5:05 p.m.
(17:05)
temp basal stop time
106
Optimizing pump therapy
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 > 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 MENU 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
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 24hours), 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.
Chapter 7
Optimizing pump therapy
107
Verifying temp basal delivery
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
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.
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.
To cancel a temp basal, do these steps:
1
2
108
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
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.
Chapter 7
Optimizing pump therapy
109
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?
110
Optimizing pump therapy
Sensor features
Chapter 8
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 flashing item by pressing
or
.
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 > Sensor Setup > Edit Settings
2
3
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 set up the sensor features.
Sensor features
111
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.
If you have turned on your Bolus Wizard feature, BG units will not be available for sensor setup. Please go
to the Setting the BG units section of the Using the Bolus Wizard feature chapter for details.
1
Make sure the EDIT SETTINGS screen is open.
2
3
4
Main > Sensor > Sensor Setup > 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 High Glucose limit.
High Glucose Alert
Your High Glucose alert must be turned on if you want your pump to alert when the sensor glucose
measurement reaches or goes above your set High Glucose limit.
To turn on your High Glucose alert, and to set the High Glucose limit:
1
2
3
4
5
112
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Sensor Setup > Edit Settings
Select High Glucose, then press ACT.
Select On, then press ACT. The SET HIGH GLUCOSE screen flashes the default High Glucose limit of
200 mg/dL (11.2 mmol/L).
Select your High Glucose limit between 110–400 mg/dL (2.8–22.2 mmol/L). Your High Glucose limit
must be at least 10 mg/dL (0.6 mmol/L) above your Low Glucose limit.
Press ACT. The EDIT SETTINGS screen shows the High Glucose value you selected. You are now ready
to set up your High Snooze.
Sensor features
Setting the High Snooze
Example
You set your High Snooze to 15 minutes. You receive an alert at 1:00 pm and immediately clear it.
However, the high glucose 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 Snooze.)
Chapter 8
After you receive and clear a High Glucose alert, it will repeat until the high glucose condition is resolved.
The High Snooze feature allows you to set how frequently you want the High Glucose 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 Snooze to one or two hours to avoid unnecessary
alerts.
To set up your High Snooze:
1
2
3
4
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Sensor Setup > Edit Settings
Select High Snooze, then press ACT. The SET HIGH SNOOZE screen flashes the default High Snooze
time of 1 hour (1:00).
Select your High Snooze time. The time must be between five minutes (0:05) and three hours (3:00).
Press ACT. The EDIT SETTINGS screen shows the High Snooze time set.
You are now ready to set up your Low Glucose limit.
Low Glucose Alert
Your Low Glucose alert must be turned on if you want your pump to alert when the sensor glucose
measurement reaches or goes below your set Low Glucose limit.
To turn on your Low Glucose alert, and to set the Low Glucose limit:
1
Make sure the EDIT SETTINGS screen is open.
2
3
Main > Sensor > Sensor Setup > Edit Settings
Select Low Glucose, then press ACT.
Select On, then press ACT. The SET LOW GLUCOSE screen flashes the default Low Glucose limit of 50
mg/dL (2.8 mmol/L).
Sensor features
113
4
5
Select your Low Glucose limit between 40–390 mg/dL (2.2–21.6 mmol/L). Your Low Glucose limit must
be at least 10 mg/dL (0.6 mmol/L) below your High Glucose limit.
Press ACT. The EDIT SETTINGS screen shows the Low Glucose value set. You are now ready to set up
your Low Snooze.
Setting the Low Snooze
After you receive and clear a Low Glucose alert, it will repeat until the low glucose condition is resolved.
The Low Snooze feature allows you to set how frequently you want the Low Glucose alert to repeat after
you clear it the first time. The Low Snooze feature works similar to the High Snooze. See the Setting the
High Snooze section in this chapter for an example.
1
2
3
4
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Sensor Setup > Edit Settings
Select Low Snooze, then press ACT. The SET LOW SNOOZE screen flashes the default Low Snooze time
of 20 minutes (0:20).
Select your Low Snooze time. The time must be between 5 minutes (0:05) and 1 hour (1:00).
Press ACT. The EDIT SETTINGS screen shows the Low Snooze time you selected. You are now ready to
set up the Alarm Snooze.
Setting the Alarm Snooze
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 Alarm Snooze feature allows you to set how frequently you want
the alert to repeat after you clear it.
1
2
3
4
114
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Sensor Setup > Edit Settings
Select Alarm Snooze, then press ACT. The SET ALARM SNOOZE screen flashes the default Alarm
Snooze time of 30 minutes (0:30).
Set your Alarm Snooze time between 5 minutes (0:05) and 1 hour (1:00).
Press ACT. The EDIT SETTINGS screen shows the Alarm Snooze time you selected. You are now ready to
set your Cal Reminder.
Sensor features
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).
1
Make sure the EDIT SETTINGS screen is open.
2
3
4
5
Main > Sensor > Sensor Setup > 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 4 hours (4:00).
Press ACT. The EDIT SETTINGS screen shows the Cal Reminder time you selected. You are now ready to
enter the ID number of your transmitter.
Chapter 8
To set up the Cal Reminder:
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.
Write the Transmitter ID of the transmitter you are using here: __________________.
1
2
3
4
5
6
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Sensor Setup > 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.
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.
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.
Sensor features
115
7
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 Missed Data.
Setting up the Missed Data feature
The Missed Data 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 Missed Data
value to 30 minutes, you will receive a WEAK SIGNAL alert 30 minutes after loss of communication.
To set up the Missed Data feature:
1
2
3
4
5
Make sure the EDIT SETTINGS screen is open.
Main > Sensor > Sensor Setup > Edit Settings
Select Missed Data, then press ACT. The SET MISSED DATA screen flashes the default time of 30
minutes (0:30).
Select your Missed Data 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 Missed Data option.
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.
Main > Sensor > Sensor Setup > Review Settings
116
2
Press
3
To change any settings, return to the EDIT SETTINGS menu.
4
Main > Sensor > Sensor Setup > 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.
to scroll through all settings to make sure that they are correct.
Sensor features
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).
Chapter 8
MiniLink
Transmitter
MiniLink
Tester
MiniLink
Charger
Transmitter charger
The transmitter contains a non-replaceable, rechargeable battery that you can recharge as needed with
the charger. The charger has a green light that shows the charging status and a red light that
communicates any problems during charging. If you see a red light, see the Understanding your
transmitter, tester, and charger section in the Troubleshooting and alarms chapter. The charger needs a
AAA or LR-03 battery to operate. A new AAA battery contains enough power to recharge the transmitter
more than 40 times.
Charging the transmitter
Before using the transmitter for the first time, you must fully charge the transmitter battery, which may
take up to eight hours. It is recommended to recharge the transmitter after each sensor use. If you choose
to recharge the transmitter after each sensor use, the charging time will be less than 20 minutes. A fully
charged transmitter battery will work more than 14 days without recharging. After 14 days of use, the
transmitter will fully recharge in less than two hours.
1
If a green light on the transmitter is lit or flashing, do not connect it to the charger. The transmitter
will not charge with its green light on. Wait for the green light to turn off, then connect the
transmitter to the charger.
Sensor features
117
2
Connect the transmitter to the charger by lining it up, flat side down, with
the charger. Push the two components together fully. Always allow at least
one minute before disconnecting the transmitter from the charger or the
transmitter may not work properly. If you disconnect the transmitter
before one minute, reconnect it to the charger for at least one minute.
3
Within 10 seconds after the transmitter is connected, a green light on the charger will flash for one to
two seconds as the charger powers on. For the rest of the charging time, the charger's green light will
flash in a continuing pattern of four flashes, pause, four flashes, pause.
green light
4
5
6
7
118
When charging is complete, the green light on the charger will stay on, without flashing, for 15 to
20 seconds and then turn off.
After the green charger light turns off, disconnect the transmitter from
the charger. The green light on the transmitter will flash for approximately
five seconds and then turn off.
If the green light on the transmitter does not flash, reconnect it to the charger for at least one
minute.
After removing the transmitter from the charger, wait at least one minute before connecting it to a
sensor or tester.
Sensor features
Starting the sensor
To start the sensor working, you must complete the following steps in order:
Insert a battery into the transmitter's charger.
Charge the transmitter battery.
Set up the sensor features.
Insert the sensor and wait five minutes.
Connect the transmitter to the sensor.
Start the sensor and wait two hours.
Enter your first meter BG.
Chapter 8
•
•
•
•
•
•
•
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 called the Sen-serter® 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
infusion set insertion site or within 3 inches (7.5 cm) from the manual
injection site.
Sensor features
119
Areas to avoid:
•
•
•
•
•
Frequently used injection or pump/sensor sites
2-inch (5.0 cm) area around navel
Site where clothing will rub or constrict
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
2
3
4
5
6
Wash your hands.
Clean the sensor site with alcohol. Let it air dry.
Remove the sensor from the package by holding the base or tape. Do not hold the sensor by the
introducer needle handle.
Place the sensor in the Sen-serter until it fits snugly.
Holding the white tape as shown, remove the clear tape using a counterclockwise motion.
Place your fingers on the back of the white tape and push the carrier down until it clicks into place.
7
8
Turn the white button to lock the Sen-serter. Remove the needle guard from the introducer needle.
Rest the Sen-serter legs flat on your skin so the Sen-serter is at a 45-degree angle or greater 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.
9 Turn the white button to unlock the Sen-serter. Press the white button to insert the sensor.
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.
120
Sensor features
Chapter 8
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.
14 Wait five 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.
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.
Sensor features
121
Connecting the transmitter to the sensor
Before connecting the transmitter to the sensor, you must have the transmitter fully charged and set up
(see Charging the transmitter and Entering the transmitter ID sections in this chapter). You must also
have the features set up and the sensor inserted (see the instructions in this chapter and those provided
with your sensor). Allow at least one minute after disconnecting the transmitter from the charger before
you can connect it to the sensor.
1
2
After the sensor is inserted, wait five minutes before connecting the transmitter. Check for bleeding.
Make sure that any bleeding has stopped, then connect the transmitter to the sensor.
Touch the inserted sensor at back of assembly to prevent movement.
sensor
3
4
5
6
122
Hold the transmitter as shown to line up the two notches on both sides with the flexible side arms of
the sensor. The transmitter's flat side with the label should face the skin.
Slide the transmitter onto the sensor and push it in firmly until the flexible side arms of the sensor
click into the notches on both sides of the transmitter. In the next 20 seconds the transmitter light will
flash green for about 10 seconds with a proper connection.
If the transmitter light does not flash, disconnect it from the sensor, wait for one minute and then
reconnect. If the transmitter light still does not flash, charge the transmitter.
After the transmitter light flashes green, use your pump to start communicating with the sensor and to
start the sensor initialization. See the next section.
Sensor features
Preparing the sensor for communication
You are now ready to use your pump to start communicating with the sensor and start sensor initialization.
The pump will start a timer and notify you when the sensor is ready to use.
Use your pump to follow the steps below:
2
3
4
5
Go to the SENSOR START MENU.
Main > Sensor > Sensor Start
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 two hours
your pump will alert you (METER BG NOW) to enter a meter BG to calibrate your sensor.
Chapter 8
1
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.
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 your sensor during times of rapid glucose change such as after eating or exercise.
Enter 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 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.
Sensor features
123
Entering meter BG
Sensor calibration will be successful only if the BG entry is in the range of 40-400 mg/dL (or 2.2 to 22
mmol/L). You should calibrate three to four times spread throughout the day for optimal results.
1
Use one of these ways for all the calibrations throughout the sensor's life, including the first
calibration after the initialization.
a. To enter a meter BG value manually, follow this path:
Main > Sensor > Enter Meter BG
b. If at the time of sensor calibration you also need to perform a bolus using the Bolus Wizard, you
can use the meter BG for both calibrating the system and bolusing. To enter a meter BG value
manually in the Bolus Wizard, press the
button on your pump, or use the MAIN MENU to go to
the ENTER BG screen:
2
124
Main > Bolus > Use Bolus Wizard
c. To enter a BG value automatically through the linked meter, test your BG with a fingerstick. The
value will be automatically sent from the meter to your pump. Make sure that your pump and the
meter are properly programmed for communication. See the Meter option section in the Using the
Bolus Wizard feature chapter for more information.
If you are manually entering your meter BG, use the up and down arrow buttons on your pump to do
so. Press ACT. For the Bolus Wizard option above, select Yes when the following screen displays: BG
TO UPDATE SENSOR
Sensor features
Using your sensor
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.
Chapter 9
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.
Reading the sensor glucose graphs
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
or 24 hours
Arrows that show the relative rate at which the most recent sensor glucose levels have risen or
fallen.
Using your sensor
125
The following conditions can prevent a real-time sensor glucose measurement from being taken:
•
•
•
•
•
•
•
•
A Lost Sensor alert.
A Sensor Error alert.
A new sensor that you just inserted is being initialized.
A Cal Error alert.
More than 12 hours has passed since the last system calibration.
Find Lost Sensor (15 minutes).
Weak signal alert.
Reconnect old sensor (two hours).
Opening and viewing the graphs
The following table describes how to use the graphs.
If you want to:
Do the following:
Open the graphs
From the HOME screen, press ESC. The 3-hour graph shows the details
for your most recent sensor glucose (SG) measurement. Press ESC again
to open the 24-hour graph.
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.
•
Press
to move the cursor left to see an earlier SG measurement.
•
Press
to move the cursor right to return to more recent SG
measurements.
126
Using your sensor
The graphs
All graphs show High and Low Glucose 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. 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.
Low Glucose
Limit Line at
58 mg/dL (3.2
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).
Chapter 9
High Glucose
Limit Line at
191 mg/dL
(10.6 mmol/L)
Indicates that your glucose has risen
above 310 mg/dL (17.2 mmol/L).
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.
Using your sensor
127
PM
2:20P
History
LOST
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.
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 P.M., and the measurement at that time was 281.
3:16P
3 Hour
281
1:00 PM
2:00 PM
3 hours
128
Using your sensor
3:00 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 A.M. and the measurement at that time was 211.
The shaded area is the 12
hours from 6:00 PM to 6:00 AM
Chapter 9
11:50A
24 Hour
211
24 hours
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.
Using your sensor
129
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 (0.11mmol/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
130
Using your sensor
Calibration history
The SENSOR UPDATE HISTORY screen lists the successful sensor calibration BG values that were entered
into the pump more than 15 minutes ago.
To view your Sensor Update History:
1
Go to the SENSOR UPDATE HISTORY screen.
2
Main > Sensor > Sensor Update Hist.
The SENSOR UPDATE HISTORY screen appears. It shows up to 28 calibration values.
The SENSOR ALARM HISTORY screen lists all of the sensor alerts that have occurred, displaying up to 36
alerts.
Chapter 9
Sensor alarm history
To view your Sensor Alarm History:
1
2
3
Go to the SENSOR ALARM HISTORY screen.
Main > Sensor > Sensor Alarm History
The SENSOR ALARM 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
131
Disconnecting the transmitter and removing the sensor
Disconnecting the sensor from the transmitter
If you are not going to replace the sensor, turn the Sensor features Off to avoid getting a LOST SENSOR
alert.
1
2
Hold the transmitter as shown, and pinch the flexible side arms of the sensor between your thumb and
forefinger.
Gently pull the transmitter away from the sensor assembly. If you need to connect the transmitter to
the tester, wait one minute after disconnecting the transmitter from the sensor.
Removing the sensor
Gently pull the sensor from your body to remove it. Place it in a sharps container.
Storage
If you do not plan to use your transmitter in the next 30 days, connect it to the charger for storage.
132
Using your sensor
Using your system in water
WARNING: Do not use your pump in water or wear it during water activities. The pump is not watertight and it may become damaged if it is used in water.
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 9
1
2
133
134
Using your sensor
Utilities
Alarm review
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.
1
4
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 10
2
3
Go to the ALARM HISTORY screen.
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.
Utilities
135
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 prime 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.
136
Utilities
a. For Insulin units:
In the WARNING UNITS screen enter the number of units you want remaining for the first warning,
then press ACT.
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
The insulin used to prime your pump is not included in the DAILY TOTALS screen. This amount is counted
separately and shown in the PRIME HISTORY screen.
Chapter 10
The DAILY TOTALS screen provides a day-by-day history of the total amount of insulin that delivered for
the past 31 days. This screen includes all bolus and basal amounts delivered midnight-to-midnight for each
of the past 31 days. The Today line in the DAILY TOTALS screen shows the amount of insulin you delivered
so far that day.
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 and meter blood glucose information for
that day.
Utilities
137
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, and BG 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 31 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, and meter blood glucose information includes daily totals and averages,
as described in the following sections.
Meter blood glucose information
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.
To view data for a single day:
1
Go to the DAILY TOTALS screen.
Main > Utilities > Daily Totals
2
Select a date and press ACT.
The BG AVG (Blood Glucose Average) screen displays. This screen shows:
• your average blood glucose for the day
• your high and low blood glucose levels for the day
• total number of blood glucose values you entered into the pump for the day
Press
3
138
to view more information.
The SEN AVG (Sensor Average) screen displays. This screen shows:
• your average of all sensor glucose measurements received during the day
• your lowest and highest sensor glucose measurement received during the day
• the number of sensor calibrations for the day
Utilities
Press
4
The INSULIN screen displays. This screen shows:
• total insulin delivered for the day
• total Basal and Bolus insulin delivered for the day
• total percentage of each (Basal and Bolus) delivered for the day
• total carbohydrates entered into the pump for the day (entered using the Bolus Wizard feature)
Press
5
to view more information.
The BOLUS screen displays. This screen shows:
• total bolus insulin delivered for the day
• total food bolus insulin, and total percentage of food bolus insulin delivered for the day
• total corr (correction) bolus insulin, and total percentage of corr bolus insulin delivered for the
day
• total man (manual) bolus insulin, and total percentage of manual boluses delivered for the day
to view more information.
Chapter 10
Press
6
to view more information.
The NUM BOLUS screen displays. This screen shows:
• total number of boluses delivered for the day
• total number of food only and correction only boluses delivered for the day
• total number of food plus correction boluses delivered for the day
• total number of manual boluses delivered for the day
To get back to the HOME screen, press
four times.
The following procedure shows you how to view insulin delivery, food intake 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
The DAILY TOTALS screen shows Daily Average selected.
Press ACT.
The DAYS TO AVERAGE screen displays. Select the number of days you want to average by pressing the
and the
. Press ACT.
Utilities
139
3
The AVG BG screen displays. This screen shows:
• the average of all blood glucose values entered into the pump for the number of previous days you
selected
• the average high and low blood glucose values for the number of previous days you selected
• the average number of blood glucose values entered into the pump per day for the number of
previous days you selected
Press
4
The SEN AVG screen displays. This screen shows:
• the average of all sensor glucose measurements for the number of previous days you selected
• the lowest and highest sensor glucose measurements for the number of previous days you selected
• the number of sensor calibrations for the number of previous days you selected
Press
5
140
to view more information.
The AVG BOLUS screen displays. This screen shows:
• the average total bolus insulin delivered per day for the number of previous days you selected
• the average total food bolus insulin, and the total average percentage of bolus insulin delivered
per day for the number of previous days you selected
• the average total correction bolus insulin, and the total average percentage of bolus insulin
delivered per day for the number of previous days you selected
• the average total manual bolus insulin, and the total average percentage of bolus insulin delivered
per day for the number of previous days you selected
Press
7
to view more information.
The AVG INSULIN (average insulin) screen displays. This screen shows:
• the average total insulin delivered per day for the number of previous days you selected
• the average total basal and bolus insulin, and total percentage of basal and bolus insulin delivered
per day for the number of previous days you selected
• the average total carbs entered into the pump per day (entered using the Bolus Wizard feature)
for the number of previous days you selected
Press
6
to view more information.
to view more information.
The NUM BOLUS screen displays. This screen shows:
• the average total number of boluses delivered per day for the number of previous days you
selected
• the average total number of food only boluses delivered per day for the number of previous days
you selected
Utilities
•
•
•
the average total number of correction only boluses delivered per day for the number of previous
days you selected
the average total number of food plus correction boluses delivered per day for the number of
previous days you selected
the average total number of manual boluses delivered per day for the number of previous days you
selected
To get back to the HOME screen, press
four times.
Personal reminders
Alarm clock
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.
Chapter 10
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.
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.
Utilities
141
To use the remote control, these pump settings must be programmed:
•
•
•
Remote Options = On
Remote control ID code entered in pump (code is on back of remote)
Easy Bolus = On
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.)
1
Go to the REMOTE OPTION screen.
2
3
Main > Utilities > Remote Options
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
142
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.
Utilities
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 statustype 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.
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
Chapter 10
1
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.
Utilities
143
Lock keypad feature
Lock keypad prevents accidental pump keypad presses. You can only press the
screen, and the
to view the STATUS
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.
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 your local help line or representative 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.
Main > Utilities > Selftest
144
Utilities
2
3
4
Select Selftest, then press ACT.
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.
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.
Chapter 10
User settings
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.
Saving the settings
Do these steps to save your current pump settings:
1
Go to the UTILITIES MENU screen and select User Settings.
Utilities
145
Main > Utilities > User Settings
2
Hold down
3
4
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.
5
and press ACT.
Restoring the settings
Do these steps to restore the most recent pump settings you have saved to your pump.
1
Go to the UTILITIES MENU screen and select User Settings.
Main > Utilities > User Settings
2
Hold down
3
4
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.
5
146
Utilities
and press ACT.
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
Go to the UTILITIES MENU screen and select User Settings.
Main > Utilities > User Settings
2
Hold down
3
4
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.
6
7
Chapter 10
5
and press ACT.
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
Go to the UTILITIES MENU screen and select User Settings.
Main > Utilities > User Settings
2
Hold down
3
The USER SETTINGS screen is displayed. Select History, then press ACT.
and press ACT.
Utilities
147
4
148
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 software
Medtronic provides software to optimize your pump use. Contact your local representative 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.
CareLink Personal is a web-based system designed to help you manage your diabetes. It has many key
features:
•
•
It copies (uploads) data from your devices: insulin pump and supported blood glucose meters.
Device data is stored on a networked 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 11
•
•
•
Reports
Reports show you data gathered from your device(s), 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.
Bolus Wizard or online logbook entry data.
Reports are displayed in PDF format. They can be viewed online, saved, or printed.
Therapy 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 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
•
•
•
Chapter 12
Every month
Review DKA prevention guidelines.
Check 03:00 blood glucose at least once during the month.
Check two-hour post-meal blood glucose for all meals on a given day
Every 3 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 ophthalmologist
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 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 the pump is working correctly. 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
5
6
Troubleshooting and alarms
Chapter 13
Check your blood glucose and take an injection if needed.
Make sure that there is insulin in your reservoir and the tubing is not kinked. If these are all right, go
to step 5.
If necessary unkink the tubing. Clear the alarm by pressing ESC and ACT. A screen will appear with
two choices: Resume and Rewind. Select Resume.
If the reservoir is empty, clear the alarm by pressing ESC and ACT. Select Rewind and change your
reservoir and infusion set per the instructions in the Starting on insulin chapter.
Continue troubleshooting by disconnecting at the quick-disconnect, and set a 10-unit Fixed Prime.
Does insulin come out of the needle at the quick-disconnect?
a. If yes, change your entire infusion set per the instructions in the Starting on insulin chapter.
If no insulin comes out of the needle at the quick-disconnect, or you receive another NO DELIVERY
alarm, call your local representative.
b. Your pump remembers the last Fixed Prime amount that was delivered, so make sure to set your
Fixed Prime amount back to your usual setting. Remember to change your Fixed Prime amount
from 10 units to your infusion set amount.
153
7
8
Monitor your blood glucose closely.
If you followed these steps and you are still receiving a NO DELIVERY alarm, call your local
representative.
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 does my pump battery not 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.
Troubleshooting and alarms
•
•
The amount of insulin the pump is delivering.
The usage of some features. The backlight, vibrate, remote control and meter options decrease
battery life.
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.
Chapter 13
Troubleshooting and alarms
155
I cannot get out of the priming loop
There are several causes of and resolutions to this problem:
1
2
3
Is the reservoir pump full?
• If no, place a full reservoir or shipping cap in the pump.
• If yes, make sure you are disconnected from the pump.
Hold the ACT button until the second set of beeps and the numbers appear on the screen.
• If yes, your pump is okay. Go to step 4 in the Manual prime section in the Starting on insulin
chapter to finish the manual prime.
• If you did not hear a second set of beeps or numbers did not appear on the screen, change your
infusion set and repeat this step.
If you still do not hear the beeps and see the number count on the screen, call the helpline or your
local representative.
The pump is asking me to rewind
This is normal after any of the following:
1
2
3
Any E-alarms,
The Clear Settings function,
Or, a NO DELIVERY Alarm (during the Prime 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.
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.
156
Troubleshooting and alarms
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 1.2 meters (4 feet) 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
Troubleshooting and alarms
Chapter 13
2
3
4
5
6
Check that all connections are still tightly in place.
If you notice that the drive support cap is loose, or sticking out, discontinue use of the pump. Do not
press on the drive support cap. Pushing on the drive support cap may result in unintended insulin
delivery, which can cause hypoglycemia. See Warnings in the Introduction chapter for more
information.
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 your local Medtronic Diabetes representative for assistance.
157
I submerged my pump in water
Your pump is designed to resist accidental contact with water. Do not submerge in water during bathing,
showering, 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.
Main > Utilities
2
Select User Settings. Hold down
3
See the User settings section in the Utilities chapter for information about the menu options.
and press ACT.
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.
158
Troubleshooting and alarms
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.
Question: Why are alerts important?
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).
What to do
1
2
3
4
Read and follow the instructions on the screen. Press ESC, ACT to silence an alert.
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 and alarms
Chapter 13
When your pump beeps or vibrates notifying you that an alert condition exists:
159
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
Reason: Occurs when the pump does not receive data from the transmitter for a pre-defined period of
time (as set in Missed Data).
Action: Move the pump closer to the transmitter or move the transmitter and the pump to the same side
of your body.
160
Troubleshooting and alarms
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 > Sensor Setup > 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 > Sensor Start > Find Lost Sensor
LOW TRANSMTR
Action: Recharge your transmitter as soon as possible. See the Charging the transmitter section of the
Sensor features chapter.
Troubleshooting and alarms
Chapter 13
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.
161
BAD TRANSMTR
Reason: The transmitter battery is depleted.
Action: Recharge your transmitter immediately. See the Charging the transmitter section in the Sensor
features chapter.
BAD 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 the HelpLine for further assistance.
SENSOR END
Reason: The sensor has reached the end of its life.
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.
CAL ERROR
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.
Action: If you receive a Cal Error, wait until your BG is stable to enter a new meter BG for calibration. If
you receive a Cal Error on your second calibration, a BAD SENSOR alert will occur. Call the HelpLine if you
have questions.
162
Troubleshooting and alarms
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.
Reason: The sensor signals are either too high or too low.
Action: You do not need to change the sensor. Clear the alert. If the alert persists, test your transmitter
with the tester.
Troubleshooting and alarms
Chapter 13
SENSOR ERROR
163
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.
It is important that you understand how your pump behaves when you do not clear an alarm or an alert.
See the Alerts section if 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.
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 attention 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 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
3
4
5
6
164
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
to
read 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.
Troubleshooting and alarms
Alarm conditions
Alarms put the pump in Attention mode.
A (ALARM)
This alarm shows a 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 the HelpLine for assistance.
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.
Chapter 13
Troubleshooting and alarms
165
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.
E (ERROR)
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 your local Medtronic Diabetes representative for assistance.
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.)
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.
166
Troubleshooting and alarms
NO DELIVERY
Insulin delivery has stopped. This alarm occurs if your pump detects a blockage.
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.
RESET
The Reset alarm triggers when pump settings are cleared because of one of these reasons:
•
•
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.
Testing the transmitter
Connecting the tester
1
Chapter 13
The tester acts like a sensor. If you get sensor-related alerts, use the tester to make sure that the
transmitter is working.
Hold the transmitter and the tester as shown. Line up the flat side of the tester with the flat side of
the transmitter.
Troubleshooting and alarms
167
2
3
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.
Main > Sensor > Sensor Start > 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 the
HelpLine. It may be time to replace your transmitter.
Disconnecting the tester
1
168
Hold the transmitter body as shown and pinch the side arms of the tester.
Troubleshooting and alarms
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 (for example, when flying on an aircraft).
To Reconnect old sensor:
1
Go to the RECONNECT OLD SENSOR screen.
2
3
Main > Sensor > Sensor Start > 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.
If you receive a Lost Sensor alert:
1
Relocate the pump closer to the sensor, and go to the SENSOR START MENU.
2
3
Main > Sensor > Sensor Start
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 and alarms
Chapter 13
Find lost sensor
169
Understanding your transmitter, tester, and charger
The charger has a green light that shows the charging status and a red light that communicates any
problems during charging. See the following graphic for the location of these lights:
green light
Question: Why did the flashing green charger
light turn off and a longer flashing red
charger light turn on during charging?
red light
about 2 secs
about 2 secs
about 2 secs
Answer: The transmitter battery is very low.
Leave the transmitter on the charger for eight hours to completely recharge. If the red light is still
flashing after eight hours, call your local representative. It may be time to replace your transmitter.
Question: Why do I see quick flashing red
lights on the charger?
about 2 secs
Answer: Your charger battery is low. Make sure
that the transmitter is not connected to the
charger. Replace the charger battery with a new AAA or LR-03 battery.
about 2 secs
Question: Why do I see a mix of quick and
long flashing red lights on the charger?
about
about
about 2 secs
Answer: Your charger and transmitter
1 sec
1 sec
batteries are very low. Replace the charger’s
AAA or LR-03 battery. If you now get the pattern for very low transmitter battery, leave the transmitter on
the charger for eight hours to recharge. If the red light is still flashing after eight hours, call our 24 Hour
HelpLine. It may be time to replace your transmitter.
Question: I had my transmitter on the charger for a day. Will this damage my transmitter?
170
Troubleshooting and alarms
Answer: It will not damage the transmitter. You cannot overcharge it.
Question: What should I do if the transmitter’s green light did not flash after removing it from the
charger?
Answer: Reconnect the transmitter to the charger for at least one minute, remove it and watch the
transmitter’s green light flash and then turn off.
Question: What should I do if the transmitter’s green light does not flash when connected to the
sensor?
Answer: Is the sensor inserted in the body? If it is not inserted, the transmitter will not flash green or send
signals to a monitoring device.
If the sensor is inserted in the body, you need to disconnect the transmitter from the sensor, wait at least
one minute and then reconnect. If the green light still does not flash, charge the transmitter.
Question: Why didn’t I see the transmitter’s green light flash after connecting it to the tester?
Answer: Check the connection. If you still do not see a green light flash, fully recharge the transmitter
battery. Test the transmitter with the tester. If you still do not see a green light flash, call the HelpLine. It
may be time to replace your transmitter.
Chapter 13
Troubleshooting and alarms
171
172
Troubleshooting and alarms
Maintenance
It is recommended that you read your warranty statement included in the Pumps specifications chapter 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 (i.e., 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
Maintenance
Chapter 14
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.
173
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
174
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 Sen-serter in the released position to maintain optimum product performance and life.
Chapter 14
Maintenance
175
176
Maintenance
Pump specifications
Chapter 15
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
Name
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
800 Hz, followed by 840 Hz, 890 Hz and 935 Hz
Low Glucose alert
935 Hz, followed by 890 Hz, 840 Hz and 800 Hz
Backlight
•
•
LCD (Liquid Crystal Display) type
Time-out: 30 seconds
Pump specifications
177
Basal
•
•
•
•
Rate increments: 0.05 units/hour
Delivery: 0.05 - 35 units/hour (maximum units: 35/hour)
Factory maximum setting: 2.0 units/hour
3 patterns maximum, each with 48 rates
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: 0.05 u
Fluid delivered/stroke: 0.5 µL (microliters)
Time between/delivery strokes: 2 seconds
Delivery rate (per minute): 1.5 u
Bolus history
Maximum records shown: 24
Bolus units
Increments: 0.1 units
Bolus Wizard feature
See the Bolus Wizard feature specifications section in this chapter for information.
178
Pump specifications
Carb ratios
Range
Warning limits
8
3 - 150 grams/u
less than 5 or greater than 50 grams/u
0.1 - 5.0 u/exch
less than 0.3 or greater than 3.0 u/exch
Carb units
The food entry when using Bolus Wizard feature:
•
•
Chapter 15
Maximum ratio settings
grams: 0 - 300 (increments: 1 gram)
exchanges 0.0 - 20 (increments: 0.5 exch)
Daily totals
Maximum records shown: 31 days of data, maximum display: 999.95 units/day. Daily delivery accuracy:
+0/-0.05 units.
Default screen
The HOME screen. For most screens, if no buttons are pressed for 30 seconds, the pump returns to this
screen.
Pump specifications
179
Delivery accuracy
•
•
•
Delivery accuracy: +/-5 percent.
Displacement (piston) accuracy: +/-2 percent.
The delivery accuracy test was done using the Sof-Set® Ultimate infusion set (MMT–315).
Delivery Volume Accuracy Curve (-0.37%) Overall Error
(MMT-522 Model) Qualification Testing (0.01 mL/hr 09/22/04 S/N: 010112-C061); 23°C
50
Maximum Error (percent)
40
Minimum Error (percent)
30
Ovreall Flow Error (percent)
Percent Error
20
10
0
0
15
30
45
60
75
90
105
120
-10
-20
-30
-40
-50
Time Interval (Minutes)
180
Pump specifications
135
150
165
180
195
210
Pump motor
The pump motor has a unique, patented design with an integrated safety check system. The system
delivers in precise increments.
Chapter 15
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
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.
Infusion pressure
Maximum infusion pressure and occlusion pressure: 13.7 PSI (94.46 kPa).
Insulin sensitivity
•
•
•
•
Maximum settings: 8
Factory default: 50 mg/dL (2.8 mmol/L)
Range: 10 - 400 mg/dL (0.5 - 22.2 mmol/L)
Warning limits: less than 20 or greater than 100 mg/dL (less than 1.1 or greater than 5.6 mmol/L)
Pump specifications
181
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 0.1 - 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 3 different situations when using U100 insulin.
182
Rate
Minimum time
before alarm
Typical time
before alarm
Maximum time
before alarm
bolus delivery (1.5 u/min)
92 seconds
116 seconds
162 seconds
basal delivery (1.0 u/h)
2.2 hours
3.09 hours
4.47 hours
basal delivery (0.05 u/h)
37.4 hours
59.2 hours
87 hours
Pump specifications
Percent temp basal
Default value: 100% of basal programming
Power supply
Prime function
•
•
•
Chapter 15
The pump is powered by a standard 1.5 V AAA alkaline battery, size E92, type LR03 (Energizer brand
recommended).
Fixed prime range: 0.1 - 25.0 units (limited by maximum bolus)
Manual prime limit: Warning at 30 units, then at each 10 units thereafter.
Fill rate: 1 to 5 units/second.
Prime history
Maximum records shown: 20 manual and fixed
Program safety checks
Maximum infusion with single fault condition: 0.0 units
Pump size
The dimensions of the pump are approximately:
•
•
522/522K Pump:
• 5.1 x 7.6 (7.1
• 2.0 x 3.0 (2.8
722/722K Pump:
• 5.1 x 9.4 (8.9
• 2.0 x 3.7 (3.5
at the battery cap) x 2.0 cm
at the battery cap) x 0.75 inches
at the battery cap) x 2.0 cm
at the battery cap) x 0.75 inches
Pump weight
•
•
522/522K pump: approximately 100 grams (with battery installed).
722/722K pump: approximately 108 grams (with battery installed).
Pump specifications
183
Remote control
Uses radio signals to allow users to program Normal boluses or to suspend/resume their pumps.
Reservoir
•
•
•
The user-filled reservoir is made from impact-resistant, insulin-compatible polypropylene.
522/522K Pump volume: up to 176 units of U100 insulin
722/722K Pump volume: up to 300 units of U100 insulin
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
•
•
•
184
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 inside the case: from 20% to 90% per EN 60601-1 2-24, Section 10.2.1c.
Pump specifications
Status screen
When
What
Alarm Clock*
(appears if scheduled to
alarm)
Time set is displayed.
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 time and date received
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 bolus information
(appears if at least one bolus
was started)
type and units delivered
Chapter 15
Item
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)
Pump model number
(always appears)
Remote: On
(appears if enabled)
Reservoir started
(always appears)
Serial number
(always appears)
Software version
(always appears)
date, time, units left, time left
Pump specifications
185
Item
When
What
Standard basal delivery data
(always appears)
current basal rate (basal 1, basal 2,
etc.)
Status of pump
(such as Rewind, Suspended, Low Reservoir, Set Time, and so on)
Time
(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 three 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
186
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.
Pump specifications
(food estimate)
total bolus
estimate =
A
B
(correction estimate)
C-D
E
+
- active insulin
2
Chapter 15
where: A = food (grams)
B = carb ratio
C = current BG
D = High BG Target
E = insullin sensitivity
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)
total bolus
estimate =
A
B
(correction estimate)
+
C-D
E
where: A = food (grams)
B = carb ratio
C = current BG
D = Low BG Target
E = insullin sensitivity
3
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)
total bolus
estimate =
4
food (grams)
carb ratio
If you do not enter a BG, the total bolus estimate is based only on the food estimate.
Pump specifications
187
Notes:
•
•
188
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
prevents the stacking of insulin, and lowers the chances of
hypoglycemia.
Pump specifications
•
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%
Chapter 15
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.
Pump specifications
189
Bolus Wizard feature examples
Settings:
•
•
•
•
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
#1: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and does not enter BG.
(food estimate)
60 g
= 2 units
30 g/u
bolus estimate = 2 units
#2: 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)
(correction estimate)
60 g
= 2 units
30 g/u
+
11.1 mmol/L - 6.7 mmol/L
= 2 units
2.2 mmol/L/u
200 mg/dL - 120 mg/dL
40 mg/dL/u
bolus estimate
190
Pump specifications
=2+2
= 4 units
= 2 units
#3: 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)
+
= 2 units
bolus estimate
3.9 mmol/L - 5.0 mmol/L
2.2 mmol/L/u
= -0.5 units
70 mg/dL - 90 mg/dL
40 mg/dL/u
= -0.5 units
Chapter 15
60 g
30 g/u
(correction estimate)
= 2 + (-0.5)
= 1.5 units
#4: 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)
60 g
30 g/u
= 2 units
(correction estimate)
+
bolus estimate
Correction is 0 because the
current blood glucose reading
is between the BG High and
Low Targets
=2+0
= 2 units
Pump specifications
191
#5: 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)
60 g
30 g/u
(correction estimate)
= 2 units
+
11.1 mmol/L - 6.7 mmol/L
2.2 mmol/L/u
= 1.5 units (active insulin)
= 0.5 units
200 mg/dL - 120 mg/dL
40 mg/dL/u
= 1.5 units (active insulin)
= 0.5 units
= 2 + 0.5
bolus estimate = 2.5 units
#6: 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)
60 g
30 g/u
= 2 units
(correction estimate)
+
11.1 mmol/L - 6.7 mmol/L
2.2 mmol/L/u
= 3.5 units (active insulin)
= -1.5 units*
200 mg/dL - 120 mg/dL
40 mg/dL/u
= 3.5 units (active insulin)
= -1.5 units*
*This negative number indicates that active insulin is sufficient to cover
the correction that is needed. Thus, correction will be 0 units. Active
insulin does not reduce the food portion of the estimate.
=2+0
bolus estimate = 2 units
192
Pump specifications
Insulin delivery default settings
Menu
Bolus Menu:
Item
Default
Setting
Off
Easy bolus:
On
Easy bolus step:
Dual/Square bolus:
Maximum bolus:
Basal Menu:
2u
Off
10.0 u
0 - 25 u (per
single bolus)
BG Reminder:
Off
0:00 - 5:00
0:30
Patterns:
Off
0.00 - 35.00 u/h
0.05 u
Maximum basal rate:
2.0 u/h
Basal rate:
0.0 u/h
Temp basal type:
Utilities
Menu:
0.1 u
Increments
Chapter 15
Bolus Wizard feature:
Limits
Lock Keypad:
U/H
(no defaults)
Alert type:
audio, beepmed
Low reservoir warning:
Max basal rate
setting
0.05 u/h (or 1%)
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
Off
(Alarm) History:
Auto-off:
0.05 u
Off
(20) insulin
units
(0:30)
Pump specifications
193
Menu
Item
Default
Setting
(Time/Date) Time:
12 a.m.
(midnight)
(Time/Date) Date:
1/1/05
(Time/Date) Time
format:
12-hour
Block:
Off
Alarm clock:
Off
Remote option:
Off
Meter option:
Off
User Settings:
(no defaults)
Language:
194
Pump specifications
English
Limits
Increments
Bolus Wizard feature default settings
Default
Setting
Limits
Increments
Warning Limits
carb units:
grams
none
none
none
ins to carb (or
exch) ratio:
15 grams/u
or
1 unit/exch
1 - 200 g/u or
0.075 - 15.0 u/exch
1 g/u or
0.1 u/exch1 g/u
5 - 50 g/u or
0.3 - 3.0 u/exch
(insulin)
sensitivity:
2.8 mmol/L
or
50 mg/dL
10 - 400 mg/dL or
0.5 - 22.2 mmol/L
1 mg/dL or
0.1 mmol/L
20 - 100 mg/dL
or
1.1 - 5.6
mmol/L
BG Target:
5.6–5.6
mmol/L
or
100–100
mg/dL
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
None
Pump specifications
Chapter 15
Item
195
Sensor features default settings
Feature
Sensor
Options
Default Setting
Limits, Range of Values
Off
None
Off
Low–22.2 mmol/L (Low–400
mg/dL)a
Off
2.2 mmol/L–High
(40mg/dL–High)b
•
On
•
Off
High Glucose
Alert
•
On
•
Off
Low Glucose
Alert
•
On
•
Off
Alarm Snooze
(Always on - cannot be turned
off)
On
30 minutes
Range: 0:05 - 1:00 (5
minutes - 1 hour)
Cal Reminder
•
On
On
1 hour
•
Off
Range: 0:05 - 4:00 (5
minutes - 4 hours)
Blood Glucose
Units (BG Units)
•
mg/dL
•
mmol/L
Missed Data
(Always on - cannot be turned
off)
mg/dL
None
30 minutes
Range: 0:05 - 0:40 (5
minutes - 40 minutes)
High Snooze
—
1:00 (1 hour)
Range: 0:05 - 3:00 (5
minutes - 3 hours)
Low Snooze
—
0:20 (20 minutes)
Range: 0:05 - 1:00 (5
minutes - 1 hour)
a.
Your High Glucose limit must be at least 0.6 mmol/L (10 mg/dL) above your Low Glucose limit.
b.
Your Low Glucose limit must be at least 0.6 mmol/L (10 mg/dL) below your High Glucose limit. For example, if your High
Glucose limit is 11.1 mmol/L (200 mg/dL), then your Low Glucose limit cannot be higher than 10.5 mmol/L (190 mg/dL).
196
Pump specifications
Guidance and manufacturer's declaration
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Emissions Test
RF emissions
Compliance
Group 1
The Paradigm 522/722/522K/722K 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 522/722/522K/722K 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.
NOTE: The preceding statement is required by
IEC 60601-1-2 for Group 1, Class B devices.
However, since the Paradigm 522/722/522K/722K
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.
CISPR 11
RF emissions
CISPR 11
Not applicable
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Electromagnetic Environment - Guidance
Not applicable
Pump specifications
Chapter 15
The Paradigm 522/722/522K/722K pump system (consisting of the MMT-522/722/522K/722K pump
and MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below.
The customer or the user of the Paradigm 522/722/522K/722K pump system should make sure that
it is used in such an environment.
197
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Paradigm 522/722/522K/722K pump system (consisting of the MMT-522/722/522K/722K pump
and MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below.
The customer or the user of the Paradigm 522/722/522K/722K pump system should make sure that
it is used in such an environment.
Immunity Test
Electrostatic discharge
(ESD)
IEC 60601 Test Level
Not applicable
±8 kV air
IEC 61000-4-2
198
Compliance
Level
Electromagnetic Environment
- Guidance
±30 kV air
(<5% relative
humidity)
The Paradigm
522/722/522K/722K 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
Pump specifications
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Immunity Test
Voltage dips, short
interruptions and
voltage variations on
power supply lines
IEC 61000-4-11
IEC 60601 Test Level
<5% UT
(>95% dip in UT)
for 0.5 cycle
Compliance
Level
Electromagnetic Environment
- Guidance
Not applicable
Not applicable
Not applicable
Not applicable
70% UT
(30% dip in UT)
for 25 cycle
Not applicable
Not applicable
<5% UT
(>95% dip in UT)
for 5 seconds
Not applicable
Not applicable
40% UT
(60% dip in UT)
for 5 cycles
Pump specifications
Chapter 15
The Paradigm 522/722/522K/722K pump system (consisting of the MMT-522/722/522K/722K pump
and MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below.
The customer or the user of the Paradigm 522/722/522K/722K pump system should make sure that
it is used in such an environment.
199
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Paradigm 522/722/522K/722K pump system (consisting of the MMT-522/722/522K/722K pump
and MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below.
The customer or the user of the Paradigm 522/722/522K/722K 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 522/522K/722/722K pump system is intended for use in the electromagnetic
environment specified below. The customer or user of the Paradigm 522/522K/722/722K 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 522/722/522K/722K pump, including
cables, than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
200
Pump specifications
10Vrms
Not applicable
Not applicable
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Paradigm 522/522K/722/722K pump system is intended for use in the electromagnetic
environment specified below. The customer or user of the Paradigm 522/522K/722/722K pump
system should make sure that it is used in such an environment.
IEC 60601
Level
Compliance
Level
Electromagnetic Environment Guidance
150kHz to
80MHz
Radiated RF
IEC 61000-4-3
10 V/m
10V/m
80MHz to
6.0GHz
d = 0.35 P
80 MHz to 800 MHz
d = 0.70 P
800 MHz to 6.0 GHz
Chapter 15
Immunity
Test
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:
NOTE:
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
Pump specifications
201
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Paradigm 522/522K/722/722K pump system is intended for use in the electromagnetic
environment specified below. The customer or user of the Paradigm 522/522K/722/722K pump
system should make sure that it is used in such an environment.
Immunity
Test
IEC 60601
Level
Compliance
Level
Electromagnetic Environment Guidance
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Paradigm 522/722/522K/722K pump is used exceeds the applicable RF compliance
level above, the Paradigm 522/722/522K/722K 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 522/722/522K/722K pump.
bOver
202
the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Pump specifications
Recommended separation distances between portable and mobile RF communications
equipment and the Paradigm 522/722/522K/722K pump system
Chapter 15
This section provides information on the recommended separation distance between portable and
mobile RF communications equipment and the Paradigm 522/722/522K/722K pump. The Paradigm
522/722/522K/722K pump is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. Paradigm 522/722/522K/722K pump users can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Paradigm 522/722/522K/722K pump as
recommended below, according to the maximum output power of the communications equipment.
Separation distance according to the frequency of transmitter (m)
800MHz to 6.0GHz
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
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.
Pump specifications
203
Icon table
Do not reuse
Attention: See 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
For more information about IPX7, see the Glossary on page 229.
Recycle
Radio communication
204
Pump specifications
Signifies compliance to Australian EMC and Radio communications
requirements
Signifies compliance with Industry Canada EMC and Radio communications
requirements
Chapter 15
Pump specifications
205
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.
206
Pump specifications
Sensor accuracy
NOTE:
You should review the information in this section with your healthcare professional.
Appendix A
The Medtronic MiniMed Paradigm 522/522K/722/722K pumps use a glucose sensor to continuously monitor
your glucose levels. The 522/522K/722/722K 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.
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 REALTime 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
reports 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
207
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:
•
•
•
•
208
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.
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.
3941
Mean Absolute Percent Difference (± SD)
19.7 ± 18.4%
Bias
Appendix A
Number of Paired Glucose Measurements
-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
209
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
210
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
Meter BG (mg/dL)
Sensor accuracy
211
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.
212
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
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.
Glucose Conc (mg/dL)
Appendix A
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
213
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%.
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)
Guardian RT Low Alert
Setting (mmol/L)
True Alert Rate*
False Alert Rate**
70
3.9
49%
60%
80
4.4
68%
64%
90
5.0
82%
75%
100
5.6
90%
79%
* True Alert Rates are the % of times when the glucose level was at or below the alert setting and the alert
sounded.
** False Alerts Rates are the % of times when the Guardian RT Sensor alarmed but the blood glucose level
was greater than the alert setting.
214
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
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 Rate*
False Alert Rate**
190
10.6
85%
64%
200
11.1
81%
58%
225
12.5
67%
40%
250
13.8
53%
25%
Appendix A
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 table below).
* True Alert Rates are the % of times when the glucose level was at or above the alert setting and the alert
sounded.
** 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
215
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.
216
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
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
Appendix A
Hours From Insertion
217
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.
218
Appendix A
Effects of calibration frequency
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
Appendix A
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
219
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
220
Appendix A
Day 2
Day 3
Day 4
Appendix A
Glucose Conc (mg/dL)
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.
Day 1
Day 2
Day 3
Day 4
Sensor accuracy
221
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
222
Appendix A
Day 2
Day 3
Day 4
Performance results in children and adolescents
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 LifeScan 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.
Accuracy of Guardian RT readings
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
Appendix A
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.
223
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
Number of Paired
Readings
Percent Within
20%
Percent Within
30%
2599
68%
82%
40-80*
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
224
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.
Appendix A
Sensor BG (mg/dL)
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
225
Stratified Clarke Error Grid Analysis
Range of
Comparative
Glucose
Readings
(mg/dL)
226
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
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
Appendix A
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 Rate*
False Alert Rate**
70
3.9
24%
48%
80
4.4
52%
46%
90
5.0
70%
52%
100
5.6
85%
57%
* True Alert Rates are the % of times when the glucose level was at or below the alert setting and the alert
sounded.
** 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
227
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 Rate*
False Alert Rate**
190
10.6
94%
40%
200
11.1
91%
36%
225
12.5
81%
21%
250
13.8
64%
13%
* True Alert Rates are the % of times when the glucose level was at or above the alert setting and the alert
sounded.
** 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.
228
Appendix A
Glossary
A
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 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).
Alarm Snooze - Once a METER
BG NOW alert occurs, the
pump will not repeat the alert
until after this selected Alarm
Snooze time.
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.
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).
Attention mode - Operating
mode that stops all current
insulin delivery. This mode
indicates an alarm or
condition exists that requires
immediate attention.
B
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%).
Alarm clock - Feature you can
set to go off at specified
times of the day.
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.
Basal patterns - The user can
program up to three different
basal rate patterns into the
pump for the delivery of basal
insulin: Standard, A, and B.
For each pattern, there is an
option of setting up to 48
basal rates.
Glossary
229
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
glucose without the help of
insulin.
Bolus - A dose of insulin given to
cover an expected rise in
230
Glossary
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.
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: 14 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.
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.
DKA - Diabetic Ketoacidosis
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 systems and devices
that use electromagnetic
energy operate properly
without causing or suffering
accidental electromagnetic
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.)
Exchange system - A system of
estimating carbohydrate and
calorie intake that groups by
type. Each exchange group
lists similar types of food in
serving sizes. A person can
exchange, trade, or substitute
a food serving in a particular
group for another food serving
in the same group.
Express bolus - Method of
delivery for any bolus type
using the express bolus button
.
F
Fats - One of the three main
classes of foods and a source
of calories or energy in foods.
Fats help the body use some
vitamins and keep the skin
healthy.
Fiber - A substance found in
foods that comes from plants.
Fiber may help in the
digestive process and is
thought to lower cholesterol
and help control blood
glucose. Fiber grams are not
absorbed, and can be
subtracted from the Total
Carbohydrate amount for
foods or meals with more
than 5 grams of fiber.
Glossary
Dual Wave® bolus - Combination
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.
interference to or from other
electromagnetic devices.
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.
Fixed prime - Fills the cannula
with insulin. This is done after
you insert the infusion set
into your body and remove
the introducer needle.
Food bolus - A dose of insulin
given to cover the expected
rise in blood glucose that
occurs after eating.
Glossary
231
G
Gastroparesis - A condition of
the digestive system that
slows down the emptying of
food from the stomach.
Glucagon - A hormone that
raises the level of glucose in
the blood. The alpha cells of
the pancreas make glucagon
when the body needs to put
more sugar into the blood.
Glucagon primarily causes
sugar stored in the liver to be
released into the blood
stream.
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.
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
232
Glossary
HDL - High-density lipoprotein A
complex of lipids and proteins
in approximately equal
amounts that functions as a
transporter of cholesterol in
the blood.
High Glucose - The pump alerts
if the sensor indicates that
your sensor glucose
measurement is at or above
this value. You have the
option to turn this feature on
or off.
High Snooze - For the High
Glucose alert, allows you to
set the delay between the
first alert and any subsequent
alerts. This allows you to
avoid getting an alert every
five minutes until the
condition is corrected.
Hold - Press and continue to
press a pump button.
Hyperglycemia - A condition in
which blood glucose values
are elevated above target.
Symptoms may include
excessive thirst, frequent
urination, dry mouth,
headache, fatigue, and
blurred vision.
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.
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.
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.
IPX7 - Protected against water
immersion. Immersion for 30
minutes at a depth of up to 1
meter.
K
Ketone
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,
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 alerts
if the sensor indicates that
your sensor glucose
measurement is at or below
this value. You have the
option to turn this feature on
or off.
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.
Low Snooze - For the Low
Glucose alert, allows you to
set the delay between the
first alert and any subsequent
alerts. This allows you to
avoid getting an alert every
five minutes until the
condition is corrected.
M
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)
Manual prime - Manual prime
fills the infusion set tubing
with insulin before you insert
the set into the body. Manual
prime is only available after
you rewind your pump.
Max basal rate - The maximum
amount of basal insulin that
the pump will deliver at one
time. (set by the user)
Max bolus - The maximum
amount of bolus insulin that
the pump will deliver at one
time. (set by the user)
Glossary
Introducer needle
(1) 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.
(2) A chemical created by the
human body when there is not
enough insulin in the blood.
that transports cholesterol in
the blood.
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.
Mineral - Minerals and vitamins
are essential micronutrients,
needed in very small amounts
to keep our bodies functioning
properly.
Missed Data - The pump alerts if
it has not received data from
the sensor for an amount of
time that you set.
Glossary
233
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.
N
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.
Nutrition - The process by which
the body draws nutrients from
food and uses them to make
or mend cells.
Nutrition label - Used to
determine the nutritional
content of foods, as well as
calories, carbohydrates, fats,
proteins, vitamin and mineral
content.
Nutritional content - The
breakdown of nutrients found
in a particular food.
234
Glossary
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.
Post-prandial reading - Blood
glucose reading taken after a
meal
Press - To push and release a
button.
Prime - To fill (prime) the
infusion set with insulin. See
Fixed prime, and Manual
prime.
Protein - One of the three main
sources of energy or calories
in food. Proteins are made of
amino acids, which are called
the building blocks of the
cells. The cells need proteins
to grow and to mend
themselves. Protein is found
in many foods such as meat,
fish, poultry, and eggs.
PSI - Pound-force per square
inch.
Pump S/N - Pump S/N is the
serial number of the pump
currently in use.
R
Reservoir - The syringe that
holds insulin.
Reset - To set again, or change
the information (reset your
glucose values).
Resume - Restarts basal delivery
after the pump is suspended.
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.
Sensitive - Easily irritated
(sensitive skin), or able to
measure very slight
differences (a sensitive
instrument).
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.
Sensor glucose (SG) - Glucose
levels in the fluid under your
skin measured by the sensor.
Set - To enter or establish a
value for your pump (set your
BG Reminder).
S/N# - Serial number.
Sodium - Is an essential element
for your body. As table salt, it
is used freely in foods as a
flavor enhancer and a
preservative. Sodium is listed
on food labels and is
expressed in milligrams.
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).
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.
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.
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.
Status - The condition of a part
of your system (battery
status, alarm/alert status).
Transmtr ID - The serial number
of the transmitter currently in
use.
Status screen - Displays the
current operations of the
pump, including active
functions, the most recent
basal and bolus deliveries,
reservoir information, and
battery condition.
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.)
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.
Step - Measurement of insulin
that you set and use for Easy
Bolus and other bolus
deliveries.
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
Temp - Temporary
Temp basal - (Tmp basal)
Temporary one-time basal
Glossary
235
236
Glossary
Index
Numerics
3-hour graph 128
24-hour graph 129
A
Meter BG By 163
Meter BG Now 163
sensor 160
Sensor End 162
Sensor Error 163
Weak Signal 160
areas
inserting infusion set 65
inserting sensor 119
Attention mode 34
auto-off 136
B
Index
accessories 3
activity guard 4
CareLink USB 3
holster 4
leather case 4
meter 3
pump clip 4
remote control 3
sensor 3
transmitter 3
active insulin 81
Active insulin time
setting 82
adverse reactions 10
alarm clock 141
Alarm conditions 165
alarm frequency 177
ALARM HISTORY screen 135
Alarm Snooze
default settings 196
setting 114
Alarm types
A (alarm) 165
Auto off 165
Batt out limit 165
Bolus stopped 165
Button error 166
check settings 155
Check settings 166
E (error) 166
Empty reservoir 166
Failed batt test 166
Max delivery 166
Motor error 166
no delivery 153
No delivery 167
No reservoir 167
Off No power 167
Reset 167
Weak battery 167
Alarms
responding to 164
review 135
alert frequency 177
alert type
Setting your 135
alerts 160
Bad Sensor 162
Bad Transmtr 162
Cal Error 162
Charge Transmtr 162
for alert conditions 160
low reservoir alert 160
High XXX MG/DL 163
Lost Sensor 161
Low Transmtr 161
Low XX MG/DL 163
backlight 33, 229
Bad Sensor alert 162
bad transmitter battery 170
Bad Transmtr alert 162
BASAL MENU 35
basal rate
daily 52
maximum 54
patterns 100
programming 51
stop delivery of 55
temp 102
bathing 133
battery, charger
low 170
Index
237
battery, pump 173, 183
install 28
removing 154
short life 154
beep/vibrate, alert type 33
BG Reminder 41, 49
BG Targets 80
BG units 78
default settings 196
selecting 112
bleeding 8, 10, 121
Block feature 143
Turn on 143
BLOCK OPTION screen 143
blood glucose
checking 123
entering incorrect
number 162
rapid change 162
blood glucose units
default settings 196
bolus
basic 41
details 47
history 46
manual 92
maximum limit 48
stop delivery of 55
bolus delivery
Bolus Wizard 85
Easy Bolus 97
bolus delivery, methods for
normal
remote control 3
BOLUS MENU 35
bolus types
Dual Wave 91
Normal 41
Square Wave 91
Bolus Wizard
about 71
entering meter BG 124
estimate details 47
238
Index
HIGH BG warning 75
how it works 75
LOW BG warning 76
MAX BOLUS EXCEEDED
warning 76
maximum delivery 76
on/off 77
review settings 82
settings 72, 73, 74, 75
Active insulin time 75
BG Ttarget range 74
BG units 73
Carb ratios 73
Carb units 73
Insulin sensitivity 74
specifications 186
your BG reading 71
bruising 10
buttons, pump 27, 29
C
Cal Error alert 162
Cal Reminder 163
default settings 196
setting 115
CAL REMINDER screen 115
CALIBRATE HISTORY 131
calibrating
frequency 123
calibrating sensor 123
frequency 123
calibration
successful 131
values 131
when to 123
Calibration history 131
Carb ratios
exchanges 78
grams 78
carb units 77
carbohydrate counting 22
CareLink Personal Software 149
CareLink USB 3
Charge Transmtr alert 162
charger 3
battery power 117
connecting with
transmitter 118
low AAA battery 170
transmitter 117
water-tightness 174
charging
transmitter 117
CHECK BG message 49
checking
blood glucose 123
choosing insertion site 120
cleaning
Sen-serter® 175
transmitter 174
cleaning the pump 174
Clear settings 147
connecting transmitter to
charger 118
sensor 122
tester 167
consumables 3
correction bolus 41, 85, 86
D
Daily totals 138
DAILY TOTALS screen
Review 137
default settings
Alarm Snooze 196
BG Units 196
Cal Reminder 196
High Glucose Alert 196
High Snooze 196
insulin delivery 193
Low Glucose Alert 196
Low Snooze 196
Missed Data 196
sensor 196
sensor features 196
discarding
transmitter 174
disconnecting
sensor from transmitter 132
tester from transmitter 168
transmitter from sensor 132
disposing
introducer needle 121
downloading pump data 3
Dual Wave bolus programming
with Bolus Wizard 95
without Bolus Wizard 92
dual/square option
on-off 92
E
F
filling
reservoir 58
FIND LOST SENSOR 169
fixed prime 67
food bolus 41, 73, 75, 85, 86
food entry 72, 85
food label 23
frequency
alarm 177
alert 177
G
graphs 127
differentiating between
current and earlier
events in 126
opening 126, 127
real-time glucose 125
real-time sensor glucose
levels 127
green light
transmitter 122, 168
H
high BG levels
Bolus Wizard and 75
HIGH BG warning 75
High Glucose Alert
default settings 196
High Glucose limit
setting 112
High Glucose Limit
alert 163
High sensor glucose alert 163
High Snooze
default settings 196
setting 113
High Snooze alert
setting 113
history
alarms 135
bolus delivery 45
calibration 131
sensor alert 131
user settings 147
HOME screen 31
I
infection 8, 10
infusion set 3, 57
changing your 60
inserting 65
best sites 65
rotating sites 65
initialization 123
inserting sensor
best sites 119
guidelines 120
procedure 120
Sen-serter 120
sites to avoid 120
steps before 119
stopping bleeding 121
warning 119
Insulin sensitivity 79
interference
transmitter 8
introducer needle 120
disposing 121
removing 121
irritation
occlusive dressing 8, 10
skin 8
ISIG 168
I.V. Prep 120
Index
Easy bolus 97
cancel 99
deliver 98
step value 97
electromagnetic emissions 197
Electromagnetic
environment 203
electromagnetic immunity 198
emergency kit 2
emissions 197
entering
meter BG 123, 124
alert 123
Bolus Wizard 124
frequency 123
manually 124
ESC 5
cancels programming 36
Examples of real-time sensor
glucose graphs 128
exercising
precaution 10
express bolus button 30
Index
239
L
Language setting 40
list
calibration values 131
sensor alert 131
Lock keypad feature 144
Lost Sensor alert 161
low battery
affects meter option 84
affects remote control 142
affects selftest 144
affects your alert type 135
low BG levels
Bolus Wizard and 76
LOW BG warning 76
Low Glucose
setting alert frequency 114
Low Glucose Alert
default settings 196
Low Glucose limit
setting 113
Low Glucose Limit
setting 163
low reservoir alert 160
Low resv warning feature 136
Low sensor glucose alert 163
Low Snooze
default settings 196
setting 114
low transmitter battery 161
Low Transmtr alert 161
LR-03 battery
low 170
M
MAIN MENU 35
manual prime 64
manually entering meter BG 124
Max basal rate 54
240
Index
MAX BOLUS EXCEEDED
warning 76
maximum bolus limit 48
menus 35
meter 3, 71
entering BG 123, 124
Meter BG By alert 163
Meter BG Now alert 163
METER BG NOW alert
setting frequency 114
meter IDs
add, delete, review 84
meter option 83
rules 84
METER OPTION screen 84
MiniLink transmitter 3
Missed Data
default settings 196
Missed Data feature 116
description 116
modes
Attention 34
Normal 34
Special 34
MWT1 3
MWT1 technology 71, 124
N
needle guard 120
no delivery 153
Normal bolus
with Bolus Wizard 85
without Bolus Wizard 41
Normal mode 34
Now 96
Now portion
of the Dual Wave bolus 93, 96
nutrition 22
O
occlusive dressing
irritation 8, 10
reaction 8, 10
P
pain 10
Patterns
basal 100
on/off 100
pattern A, B 100
Program a basal pattern 100
Select a basal pattern 101
standard basal pattern 100
Personal reminders 141
personal settings 72
practicing 62
precaution
sensor 10
preparing sensor sites 120
prime
fixed 67
manual 64
PRIME MENU 36
procedure, inserting sensor 120
programming sensor 111
pump
battery compartment 27
buttons 27, 29
if you remove your 37
screen 27, 31
using in water 158
warranty 206
R
reaction to occlusive
dressing 8, 10
S
Save settings 145
scroll bar 33
Selftest 144, 157
Sen-serter
inserting sensor 119, 120
removing from sensor 121
Sen-serter®
cleaning 175
sensor
alerts 131, 160
history 131
list 131
best sites 119
calibrating 123, 163
caution inserting 119
choosing insertion site 119
connecting with
transmitter 122
default settings 196
disconnected 161
disconnecting from
transmitter 132
improper insertion 119
information 125
inserting 119, 120, 121
bleeding 121
guidelines 120
procedure 120
ISIG 168
life 162
precaution 10
programming 111
reconnecting 169
removing 132
setting up 111
signal 119
signals 163
too high 163
too low 163
sites 120
preparing 120
stabilizing 162
starting 119
status screens 125
Transmitter ID 115
using in water 133
warnings 8, 119
SENSOR ALARM HISTORY 131
sensor alerts
Bad Sensor 162
Bad Transmtr 162
Cal Error 162
Charge Transmtr 162
High XXX MG/DL 163
Lost Sensor 161
Low Transmtr 161
Low XX MG/DL 163
Meter BG By 163
Meter BG Now 163
Sensor End 162
Sensor Error 163
Weak signal 160
Sensor End alert 162
Sensor Error alert 163
Sensor function 35
sensor glucose levels
graphs 127
SENSOR ON/OFF screen 111
SENSOR STATUS 125
Sensor update history 131
SET ALARM SNOOZE screen 114
SET CAL REMINDER screen 115
SET MISSED DATA screen 116
SET TRANSMITTER ID screen 115
setting
Alarm Snooze 114
Cal Reminder 115
High Glucose limit 112
High Snooze 113
Low Glucose limit 113
Low Snooze 114
setting up sensor 111
settings, reviewing 116
showering 133
sites
inserting sensor 119
Index
Index
reading the real-time glucose
graphs 125
real-time glucose graphs
reading 125
real-time sensor glucose
levels 127
RECONNECT OLD SENSOR 169
Reminder, alarm clock 141
remote control 3
remote control IDs
add, delete, review 142
Remote control option
turn on 142
removing
introducer needle 121
needle guard 120
sensor 132
removing your pump 37
reservoir
filling the 58
inserting in your pump 62
low reservoir warning 136
plunger rod 58
removing the 60
transfer guard 58
tubing connector 27
reservoirs 3
Restore settings 146
REVIEW SETTINGS screen 116
reviewing
sensor settings 116
rewinding your pump 62
during practice 62
RF communications 203
RF features
meter 83
remote control 141
use on aircraft 10
241
skin
bleeding 8, 10
bruising 10
infection 8, 10
redness 10
swelling 8, 10
Special mode 34
Square portion
of the Dual Wave bolus 96
Square Wave bolus programming
with Bolus Wizard 95
without Bolus Wizard 92
starting sensor
procedure 123
steps before 119
STATUS screen 36
Step value setup 97
stopping bleeding 121
supplies, ordering 4
Suspend function 35, 55
swelling 8, 10
swimming 133
system initialization 123
T
Temp basal
Canceling a 108
Deliver a 107
rates 102
Selecting type 107
verify delivery 108
temp basal types
Insulin rate 103
Percent of basal 105
tenderness 10
terms and symbols 5
test plug. See tester 168
242
Index
tester 3
connecting to
transmitter 167
disconnecting from
transmitter 168
transmitter 117
water-tightness 174
therapy follow-up
Recommended 151
time and date, setting 39
transmitter
bad battery 170
battery 117
before attaching 121
charger 117
charging 117
charging complete 118
cleaning 174
connecting with charger 118
connecting with sensor 122
depleted battery 162
discarding 174
disconnected 161
disconnecting from
sensor 132
end of life 170, 171
green light 122, 168
interference 8
light 122
lights 118
low battery 161
signal 119
tester 3, 117
troubleshooting 117
using in water 133
warning 8
Transmitter ID
setting 115
troubleshooting 169
U
user safety
adverse reactions 10
User settings 145
User Settings screen 158
Utilities 135
UTILITIES MENU 36
V
viewing
calibration values 131
sensor alarm history 131
W
warnings
sensor 8
transmitter 8
warranty 206
water, using your system in 133
water-tightness 133
charger 174
tester 174
Weak Signal 160
Weak Signal alert 160
6025250-011C
112106
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement