Insulin pump and continuous glucose monitoring system

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.
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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
When charging is complete, the green light on the charger will stay on, without flashing, for 15 to
20 seconds and then turn off.
5
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.
6
If the green light on the transmitter does not flash, reconnect it to the charger for at least one
minute.
7
After removing the transmitter from the charger, wait at least one minute before connecting it to a
sensor or tester.
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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.
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.
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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
Wash your hands.
2
Clean the sensor site with alcohol. Let it air dry.
3
Remove the sensor from the package by holding the base or tape. Do not hold the sensor by the
introducer needle handle.
4
Place the sensor in the Sen-serter until it fits snugly.
5
Holding the white tape as shown, remove the clear tape using a counterclockwise motion.
6
Place your fingers on the back of the white tape and push the carrier down until it clicks into place.
7
Turn the white button to lock the Sen-serter. Remove the needle guard from the introducer needle.
8
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.
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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.
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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
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.
2
Touch the inserted sensor at back of assembly to prevent movement.
sensor
3
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.
4
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.
5
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.
6
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.
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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:
1
Go to the SENSOR START MENU.
Main > Sensor > Sensor Start
2
Select New Sensor. Press ACT.
3
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.
4
After your sensor is connected, press ACT. The SENSOR READY 2 HRS screen appears.
5
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. 
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.
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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:
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.
2
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
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Using your sensor
Status screens
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.
 
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.
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.
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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.
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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. 
Indicates that your glucose has risen 
above 310 mg/dL (17.2 mmol/L).
Sensor glucose data 
points.
Each time you 
bolus, a marker will 
appear on your 
graph.
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).
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).
High Glucose 
Limit Line at 
191 mg/dL 
(10.6 mmol/L) 
Low Glucose 
Limit Line at  
58 mg/dL (3.2 
mmol/L) 
3:16P
281
3 Hour
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.
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2:20P
History
LOST
SENSOR
PM
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
281
1:00 PM
2:00 PM
3:00 PM
3 hours
3 Hour
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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.
211
24 Hour
11:50A
The shaded area is the 12 
hours from 6:00 PM to 6:00 AM
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.
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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. 
240
3:16P
3 Hour
•
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
131
3 Hour
•
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
212
3 Hour
•
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
103
3 Hour
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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.
Main > Sensor > Sensor Update Hist.
2
The SENSOR UPDATE HISTORY screen appears. It shows up to 28 calibration values. 
Sensor alarm history 
The SENSOR ALARM HISTORY screen lists all of the sensor alerts that have occurred, displaying up to 36
alerts.
 
To view your Sensor Alarm History: 
1
Go to the SENSOR ALARM HISTORY screen.
Main > Sensor > Sensor Alarm History
2
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. 
3
A new screen will appear with the alert details.
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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
Hold the transmitter as shown, and pinch the flexible side arms of the sensor between your thumb and
forefinger.
2
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.
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132

Using your system in water
WARNING: Do not use your pump in water or wear it during water activities. The pump is not water-
tight 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:
1
Disconnect the infusion set from the pump and remove the pump. The pump is not water-tight.