Insulin pump and continuous glucose monitoring system

part of dual wave bolus, DS = Square

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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)
date, time, units left, time left
Serial number
(always appears)
Software version
(always appears)
Pump specifications
185
Chapter 15

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
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
186

(food estimate)
A
B
where:
+
=
(correction estimate)
total bolus
estimate
C - D
E
A = food (grams)
B = carb ratio
C = current BG
D = High BG Target
E = insullin sensitivity
- active insulin
2
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)
A
B
where:
+
=
(correction estimate)
total bolus
estimate
C - D
E
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)
food (grams)
carb ratio
=
total bolus
estimate
4
If you do not enter a BG, the total bolus estimate is based only on the food estimate.
Pump specifications
187
Chapter 15

Notes:
•
If a Dual Wave bolus is less than the estimate due to the max bolus limit or a user change, the square
(sq) portion is reduced first.
•
Based on the Active Insulin Time setting you choose, the pump
keeps track of how much insulin is still active in your body. This
prevents the stacking of insulin, and lowers the chances of
hypoglycemia.
Pump specifications
188

•
The Bolus Wizard feature may utilize your current BG measurement, carbohydrate consumption, and
active insulin to calculate your estimated bolus.
•
Active Insulin Curves
% Insulin
Remaining
Time (hours)
Active Insulin Curve
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0
1
2
3
4
5
6
9
7
8
8 Hour
7 Hour
6 Hour
5 Hour
4 Hour
3 Hour
2 Hour
Graph adapted from Mudaliar and colleagues, Diabetes Care, Volume 22, Number 9, Sept. 1999, page
1501.

Pump specifications
189
Chapter 15

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
30 g/u
= 2 units
= 2 units
bolus estimate
#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)
60 g
30 g/u
= 2 units
= 2 units
+
(correction estimate)
= 2 + 2
= 4 units
bolus estimate
11.1 mmol/L - 6.7 mmol/L
2.2 mmol/L/u
= 2 units
200 mg/dL - 120 mg/dL
40 mg/dL/u
Pump specifications
190

#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)
60 g
30 g/u
= 2 units
= -0.5 units
+
(correction estimate)
= 2 + (-0.5)
= 1.5 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
#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)
= 2 + 0
= 2 units
bolus estimate
Correction is 0 because the
current blood glucose reading
is between the BG High and
Low Targets
Pump specifications
191
Chapter 15

#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
= 2 units
= 1.5 units (active insulin)
+
(correction estimate)
= 2 + 0.5
= 2.5 units
bolus estimate
11.1 mmol/L - 6.7 mmol/L
2.2 mmol/L/u
= 1.5 units (active insulin)
200 mg/dL - 120 mg/dL
40 mg/dL/u
= 0.5 units
= 0.5 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
= 3.5 units (active insulin)
+
(correction estimate)
= 2 + 0
= 2 units
bolus estimate
11.1 mmol/L - 6.7 mmol/L
2.2 mmol/L/u
= 3.5 units (active insulin)
200 mg/dL - 120 mg/dL
40 mg/dL/u
= -1.5 units*
= -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.
Pump specifications
192

Insulin delivery default settings
Menu
Item
Default
Setting
Limits
Increments
Bolus Menu:
Bolus Wizard feature: Off
Easy bolus: On
Easy bolus step: 0.1 u
2 u
Dual/Square bolus: Off
Maximum bolus: 10.0 u
0 - 25 u (per
single bolus)
BG Reminder: Off
0:00 - 5:00
0:30
Basal Menu:
Patterns: Off
Maximum basal rate: 2.0 u/h
0.00 - 35.00 u/h
0.05 u
Basal rate: 0.0 u/h
0.05 u
Temp basal type: U/H
Max basal rate
setting
0.05 u/h (or 1%)
Utilities
Menu:
Lock Keypad: Off
(Alarm) History: (no defaults)
Alert type: audio, beep-
med
Auto-off: Off
Low reservoir warning: (20) insulin
units
if units: 1st @ 5
- 50 u; 2nd @
half amount
remaining (if
time: 1st @ 2:00
- 24:00; 2nd @
1:00 hour before
empty)
20 u
(0:30)
Pump specifications
193
Chapter 15

Menu
Item
Default
Setting
Limits
Increments
(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: English
Pump specifications
194

Bolus Wizard feature default settings
Item
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
195
Chapter 15

Sensor features default settings
Feature
Options
Default Setting
Limits, Range of Values
Sensor
•
On
•
Off
Off
None
High Glucose
Alert
•
On
•
Off
Off
Low–22.2 mmol/L (Low–400
mg/dL)
a
Low Glucose
Alert
•
On
•
Off
Off
2.2 mmol/L–High
(40mg/dL–High)
b
Alarm Snooze
(Always on - cannot be turned
off)
On 30 minutes
Range: 0:05 - 1:00 (5
minutes - 1 hour)
Cal Reminder
•
On
•
Off
On 1 hour
Range: 0:05 - 4:00 (5
minutes - 4 hours)
Blood Glucose
Units (BG Units)
•
mg/dL
•
mmol/L
mg/dL
None
Missed Data
(Always on - cannot be turned
off)
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).
Pump specifications
196

Guidance and manufacturer's declaration
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
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.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions
CISPR 11
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.
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Class B
Not applicable
Not applicable
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.

Pump specifications
197
Chapter 15

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
IEC 60601 Test Level
Compliance
Level
Electromagnetic Environment
- Guidance
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE:
U
T
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
Conducted RF
IEC 61000-4-6
10Vrms
Not applicable
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
Not applicable
Pump specifications
200

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
Radiated RF
IEC 61000-4-3
150kHz to
80MHz
10V/m
80MHz to
6.0GHz
10 V/m
d = 0.35 P
80 MHz to 800 MHz
d = 0.70 P
800 MHz to 6.0 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
,
should be less than the compliance level in each
frequency range
b
.
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.

a
Field 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
Chapter 15

Recommended separation distances between portable and mobile RF communications
equipment and the Paradigm 522/722/522K/722K pump system
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)
Rated maximum
output power of
transmitter (W)
80MHz to 800MHz
d = 0.35 P
800MHz to 6.0GHz
d = 0.70 P
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
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

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