Insulin pump and continuous glucose monitoring system

Appendix A

Time-elapsed plots
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.
Glucose Conc
 (mg/dL)
Day 1
Day 4
Day 2
Day 3
Appendix A
220

The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucose
reading, where sensor showed average (typical) performance. The open circles (o) on the graph represent
the meter calibration readings. The closed circles (•) represent the reference blood glucose readings, and
the solid line (—) represents the sensor glucose value.
Glucose Conc
 (mg/dL)
Day 1
Day 4
Day 2
Day 3
Sensor accuracy
221
Appendix A

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.
Glucose Conc
 (mg/dL)
Day 1
Day 4
Day 2
Day 3
Appendix A
222

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
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.
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
223
Appendix A

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)
Number of Paired
Readings
Percent Within
20%
Percent Within
30%
Overall
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
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
224

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.
Meter BG (mg/dL)
Sensor BG (mg/dL)
A (1733, 66.7%)
B (665, 25.6%)
C (7, 0.3%)
D (193, 7.4%)
E (1, 0.0%)
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
Appendix A

Stratified Clarke Error Grid Analysis
Range of
Comparative
Glucose
Readings
(mg/dL)
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
226

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
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
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
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.
Appendix A
228

Glossary
 
A
A1C (HbA1c) test - A 2-3 month
average of blood glucose
values expressed in percent.
The normal range varies with
different labs and is
expressed in percent (such as
4 - 6%).
Accept - Pressing the ACT button
to approve the selection or
setting.
Active insulin - Bolus insulin
that has been delivered to
your body, but has not yet
been used.
Adverse reaction - An
unexpected, unpleasant or
dangerous reaction to a
sensor when it is inserted into
the body. An adverse reaction
may be sudden or may
develop over time.
Alarm - Audible or vibrating
(silent) notice that indicates
the pump is in Attention
mode and immediate
attention is required. Alarms
are prefixed in the alarm
history with the letter A.
Alarm clock - Feature you can
set to go off at specified
times of the day.
ALARM HISTORY - Screen that
displays the last 36 alarms/
errors that have occurred on
your pump.
Alarm icon - a solid circle that
shows at the top of the screen
and the pump beeps or
vibrates periodically until the
condition is cleared (see
Attention mode).
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
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
Glossary

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
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
Glossary
230

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
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.
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
interference to or from other
electromagnetic devices.
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.
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
Glossary

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
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, non-
responsiveness 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
Glossary
232

what size bolus you should
take when eating
carbohydrates. Your
healthcare professional will
determine your insulin to
carbohydrate ratio.
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.
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,
that transports cholesterol in
the blood.
Link - To turn on and setup the
meter option that allows the
pump to receive BG readings
from a meter that
communicates with your
pump.
Log - A record of measurements,
alarms or other actions by
your pump.
Low Glucose - The pump 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)
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
Glossary

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.
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).
Glossary
234

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).
Set bolus - Selectable item
available in the BOLUS MENU
when the Bolus Wizard
feature is inactive. One
method of programming a
bolus without the Bolus
Wizard feature. (See Manual
bolus.)
S/N# - Serial number.
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).
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.
Standard pattern - Your normal
basal that supports your usual
day-to-day activity. When the
Patterns feature is off, the
pump uses your standard
basal pattern.
Status - The condition of a part
of your system (battery
status, alarm/alert status).
Status screen - Displays the
current operations of the
pump, including active
functions, the most recent
basal and bolus deliveries,
reservoir information, and
battery condition.
Step - Measurement of insulin
that you set and use for Easy
Bolus and other bolus
deliveries.
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
insulin with a specified
amount and duration. Used to
support insulin needs for
special activities or conditions
that are not part of the
normal daily routine.
Timeout - If you do not enter
information or do something
in a specific length of time,
your pump automatically
stops what it is doing and
goes to the HOME screen.
Transmtr ID - The serial number
of the transmitter currently in
use.
Glossary
235
Glossary

Glossary
236

Index
 
Numerics
3-hour graph  128
24-hour graph  129
A
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
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
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
Index

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
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
Index
238

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
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
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
239
Index

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
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
Index
240

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
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
241
Index

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
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
Index
242

6025250-011C    112106

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