User Manual - Apex medical
TruCare® is a registered trademark of Apex Medical.
is a registered trademark of Apex Medical.
Rx Only
Wuxi Apex Medical Co., Ltd.
Add: Suit 607, 5Bld., No.7 Changjiang Road, High Tech. Area, Wuxi, Jiangsu, China 214028
Tel: +86-510-80100606
Shanghai International Holding Corp. GmbH (Europe)
Add: Eiffestrasse 80, 20537 Hamburg, Germany
Tel: +49-40-2513175
Important Safety Information Regarding Your
TruCare Insulin Pump (includes all models)
Avoid Immersing Your Pump In Water
Although it is unlikely that water damage will occur if your pump is splashed or briefly dunked, you should avoid immersing your
TruCare insulin pump in water. To swim or participate in other water activities, always disconnect from your TruCare insulin
pump and reconnect after water play.
If you inadvertently submerge your pump in water, dry the pump instantly using a soft, clean towel and verify if it is working properly by
selecting “self test”under 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
Help Line at 86-510-80100606 for further assistance. Symptoms of high blood glucose include fatigue, excessive thirst and nausea. You
should always contact your healthcare professional if you experience excessively high or low blood glucose levels, or if you have any
questions about your care.
Electrostatic Discharge
Although your TruCare insulin pump is designed to be not affected by generally levels of electrostatic discharge (ESD), high levels of
ESD can result in a reset of the pump’s software.
Please contact our 24-Hour Help Line at 86-510-80100606 to report any error alarms or other problems that occur with your pump.
PLEASE READ THIS ENTIRE USER GUIDE BEFORE YOU
TRY TO OPERATE YOUR PUMP.
1
Table of contents
Glossary ....................................................................................... 错误!未定义书签。
Your personal information ......................................................................... 10
Basal rate ............................................................................................................................ 10
Insulin type ..........................................................................................................................11
Carb ratios (meal bolus info) ...........................................................................................11
BG targets ............................................................................................................................11
Insulin sensitivity ................................................................................................................11
Introduction ............................................................................................................... 12
Purpose ............................................................................................................................... 12
How to use this guide.......................................................................................................13
Chapter 1
Before you begin. . . ....................................................... 14
Availability .......................................................................................................................... 14
Assistance .......................................................................................................................... 14
Emergency kit..................................................................................................................... 14
Disposables ........................................................................................................................ 15
Practice, practice, practice. . . ......................................................................................... 15
Chapter 2
The basics. . .
......................................................................... 16
Your pump........................................................................................................................... 16
Install battery ...................................................................................................................... 17
Pump buttons ..................................................................................................................... 19
The pump screen ............................................................................................................... 20
Scroll bar .......................................................................................................................... 20
Screen backlight............................................................................................................... 20
Beep/vibrate ........................................................................................................................ 20
HOME screen ...................................................................................................................... 21
Operating modes................................................................................................................ 21
Menus .................................................................................................................................. 22
STATUS screen ................................................................................................................... 23
Alert conditions .................................................................................................................. 24
What to do... ................................................................................................................... 24
Alerts for special features ................................................................................................. 25
If you remove your pump. . . ........................................................................................... 25
2
Pump settings .................................................................................................................. 25
Insulin ............................................................................................................................... 25
Chapter 3 Basic programming .............................................................. 26
Setting the time and date .................................................................................................. 26
BG reminder ....................................................................................................................... 27
Bolus ................................................................................................................................... 28
Normal bolus .................................................................................................................... 28
Review your bolus deliveries ............................................................................................ 33
Maximum bolus limit.............................................................................错误!未定义书签。
Basal .................................................................................................................................... 34
Start and stop times ......................................................................................................... 34
Your basal settings ........................................................................................................... 35
Basal programming and delivery ..................................................................................... 35
Basal review ..................................................................................................................... 37
Max basal rate .................................................................................................................... 38
Stopping your pump .......................................................................................................... 39
Resume pump delivery ...................................................................................................... 41
Chapter 4
Starting on insulin ........................................................... 42
Prepare your pump for use ............................................................................................... 42
Filling the reservoir .......................................................................................................... 43
Changing your infusion set ............................................................................................. 45
Removing the reservoir .................................................................................................... 45
Rewinding your pump ...................................................................................................... 46
Inserting the reservoir in your pump ................................................................................ 47
Manual prime ................................................................................................................... 48
Insert the infusion set ..................................................................................................... 49
Fixed prime ...................................................................................................................... 53
Prime history ...................................................................................................................... 53
Record keeping for diabetes management ..................................................................... 54
Determining your pump settings...................................................................................... 54
Using your daily journal .................................................................................................... 55
Chapter 5
Using Bolus Wizard ....................................................... 56
What is it? ........................................................................................................................... 56
Information you need. . . .................................................................................................. 56
Food entry ........................................................................................................................ 56
Your BG reading ............................................................................................................... 56
Your personal Bolus Wizard settings ............................................................................... 56
How the Bolus Wizard works ............................................................................................ 59
3
More about Bolus Wizard. . . .......................................................................................... 59
How to program Bolus Wizard .......................................................................................... 61
Bolus Wizard on/off .......................................................................................................... 61
Carb units ......................................................................................................................... 61
Carb/Exch ratios............................................................................................................... 62
BG units............................................................................................................................ 64
Insulin sensitivity .............................................................................................................. 64
BG targets ........................................................................................................................ 65
Review your Bolus Wizard settings ................................................................................. 66
Normal bolus using Bolus Wizard .................................................................................... 67
Chapter 6
Optimizing pump therapy........................................ 71
Square Wave and Dual Wave bolus ................................................................................. 71
Dual Wave/Square Wave bolus on-off ............................................................................. 71
Square Wave or Dual Wave bolus without Bolus Wizard ................................................ 72
Using Bolus Wizard for a Square Wave or Dual Wave bolus .......................................... 76
Basal schemes ................................................................................................................... 78
Select a schemes ............................................................................................................. 78
Temp basal rates ................................................................................................................ 80
How does temp basal work? ............................................................................................ 80
Temp basal types ............................................................................................................. 80
Selecting temp basal type ................................................................................................ 82
Deliver a temp basal ........................................................................................................ 82
Canceling a temp basal.................................................................................................... 83
Chapter 7
Insulin pump therapy follow-up .......................... 86
Chapter 8
Utilities............................................................................................ 87
Alarm review ....................................................................................................................... 87
Setting your alert type ....................................................................................................... 87
Low reservoir warning ....................................................................................................... 88
Review daily insulin totals ................................................................................................ 88
Block feature ...................................................................................................................... 89
Turn block on.................................................................................................................... 89
Selftest ................................................................................................................................ 90
Clear pump ......................................................................................................................... 91
Language setting.............................................................................................................. 91
Chapter 9 Troubleshooting and alarms ....................................... 92
Troubleshooting ................................................................................................................. 92
4
My pump has a no delivery alarm. . . ............................................................................. 92
What happens if I leave the battery out too long? ........................................................... 93
My screen appears distorted... ......................................................................................... 93
My bolus stopped. . . ...................................................................................................... 93
I dropped my pump .......................................................................................................... 94
I submerged my pump in water ........................................................................................ 94
Alarms ................................................................................................................................. 95
Why are alarms important? .............................................................................................. 95
What to do ........................................................................................................................ 95
Alarm conditions............................................................................................................... 96
Chapter 10
Pump maintenance ..................................................... 99
Battery ................................................................................................................................. 99
Storage ................................................................................................................................ 99
Cleaning your pump ........................................................................................................ 100
Repair ................................................................................................................................ 100
Chapter 11
User safety ......................................................................... 101
Indications ........................................................................................................................ 101
Contraindications............................................................................................................. 101
Warnings ........................................................................................................................... 101
Wearing your pump ......................................................................................................... 101
When not to wear your pump.........................................................................................102
Traveling ........................................................................................................................... 102
Accidental Contact with Water........................................................................................ 103
Precautions ....................................................................................................................... 103
Chapter 12
Pump specifications ................................................ 104
Air humidity ...................................................................................................................... 104
Barometric pressure ........................................................................................................ 104
Temperature ranges ......................................................................................................... 104
Alarms and error messages ............................................................................................ 104
Backlight ........................................................................................................................... 104
Default screen .................................................................................................................. 104
Status screen .................................................................................................................... 105
Basal .................................................................................................................................. 105
Temporary(temp)basal rate ............................................................................................. 105
Delivery accuracy............................................................................................................. 105
Bolus ............................................................................................................................... 108
Dual Wave bolus............................................................................................................... 108
5
Square Wave bolus .......................................................................................................... 108
Prime ............................................................................................................................... 108
Alarm history .................................................................................................................... 109
Daily totals ........................................................................................................................ 109
Drive motor ....................................................................................................................... 109
(Insulin)sensitivity............................................................................................................ 109
Insulin type ....................................................................................................................... 109
Low resv(reservoir)warning ............................................................................................ 109
Infusion pressure ............................................................................................................. 109
Occlusion detection ..........................................................................................................110
Maximum volume before alarm .......................................................................................110
Maximum quantity delivered at a single fault condition ...............................................110
Power supply .....................................................................................................................110
Battery life ..........................................................................................................................110
Data storage time ..............................................................................................................110
BG target ............................................................................................................................ 111
Carb ratios ......................................................................................................................... 111
Carb units........................................................................................................................... 111
Pump size .......................................................................................................................... 111
Pump weight ...................................................................................................................... 111
Reservoir ............................................................................................................................ 111
Water tight.......................................................................................................................... 111
Service life .........................................................................................................................112
Pump casing ......................................................................................................................112
Technical standards on Electromagnetic Emissions ....................................................112
Technical standards on Electromagnetic Immunity ......................................................113
Sterile Products and Accessories ...................................................................................115
Bolus Wizard specifications ..........................................................................................116
Default settings ...............................................................................................................118
Menu map ..........................................................................................................................119
Icon table........................................................................................................................... 120
6
Glossary
A
Accept - Pressing the ACT button to approve the selection or
setting.
BG Reminder - Feature that you can set to remind you to
check your blood glucose after a bolus.
Active Insulin - Bolus insulin that has been delivered to your
BG target - normal blood glucose level
body, but has not yet been used.
BG unit - blood glucose unit of measure (mg/dL or mmol/L)
Alarm - Audible or vibrating (silent) notice that indicates the
Block - Feature that restricts access to all programming except
pump is in Attention mode and immediate attention is required.
suspend and selftest.
Alarm history - Screen that displays the last 32 alarms/errors
Bolus - A dose of insulin given to cover an expected rise in
that have occurred on your pump.
blood glucose (such as the rise after a meal) or to lower a high
blood glucose down to target range.
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.
BOLUS HISTORY - This screen displays the last 32 boluses
Attention mode - Operating mode that stops all current
Bolus Wizard - Feature that calculates the bolus amount
delivered by your pump.
insulin delivery. This mode indicates an alarm or condition exists
that requires immediate attention.
based on personal information of the pump user.
C
B
Carb ratio - (Carbohydrate ratio)
Backlight - Pump screen light. Turns on whenever the
Used when counting carbohydrates in grams. The amount of
carbohydrates covered by one unit of insulin. (Also see exch
ratio.)
button is pressed from the HOME screen, or during an
down
alarm (except LOW BATT) .
Carb units - The food entry when using the Bolus Wizard.
Entered as (carbohydrate) grams or exchanges.
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.
CHO – Carbohydrate
Correction Bolus - The amount of insulin needed to return a
high blood glucose level back down to target range.
BASAL REVIEW screen - shows the basal rates
Correction Bolus factor - How much 1. 0 unit of insulin will
programmed in the pump, with the 24-hour total for each rate.
lower your blood glucose. This factor is used to calculate a
BG - Blood Glucose
7
correction bolus amount when your blood sugar is high.
(BG level) – (BG target) = X.
X ÷ (corr bolus factor) = corr bolus amount
Gastroparesis - A condition of the digestive system that slows
down the emptying of food from the stomach.
H
D
HbA1c - Glycosylated hemoglobin
HDL - high-density lipoprotein
Daily totals - Shows the total insulin delivered (basal and
bolus) in the last 24-hours.
Maximum records: 40 days
A complex of lipids and proteins in approximately equal amounts
that functions as a transporter of cholesterol in the blood.
Hold - Press and continue to press a pump button.
DKA - Diabetic Ketoacidosis
I
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.
Idle - The pump is at the HOME screen.
Ins sensitivity - The amount that your blood glucose (BG)
level is reduced by one unit of insulin. (Bolus Wizard data)
Duration - Amount of time it takes to administer a bolus or
basal delivery. Also, length of time for an action or condition.
Insulin type -Type of insulin used: U100 fast acting.
E
L
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.)
LDL - low-density lipoprotein
A complex of lipids and proteins, with greater amounts of lipid
than protein, that transports cholesterol in the blood.
M
Express bolus - Method of delivery for any bolus type using
the express bolus button
Manual bolus - Selectable item available in the BOLUS
MENU when Bolus Wizard is active. One method of
programming a bolus without Bolus Wizard. (see “Set bolus”)
.
F
Manual prime - Fills the infusion set tubing with insulin before
Fixed prime - Fills the cannula with insulin. This is done after
you insert the set into your body. (This function is available
after a rewind)
you insert the infusion set into your body and remove the
introducer needle.
Max bolus - The maximum amount of bolus insulin that the
Food bolus - A dose of insulin given to cover the expected rise
pump will deliver at one time. (set by the user)
in blood glucose that occurs after eating.
Max basal rate - The maximum amount of basal insulin that
the pump will deliver at one time. (set by the user)
G
8
Set bolus - Selectable item available in the BOLUS MENU
N
when Bolus Wizard is inactive. One method of programming a
bolus without Bolus Wizard. (see ”Manual bolus”)
Normal bolus - An immediate delivery of a specified unit
amount of insulin.
Special mode - Operating mode that indicates one or more
special functions is active or a condition exists that requires
attention.
Normal mode - Regular operating mode. No special features
are active, no alert or alarm conditions exist. Insulin delivery is
normal during this mode.
Square Wave bolus - Immediate bolus delivered evenly over
Now - The “Normal” portion of a Dual Wave bolus. The now
portion delivers immediately and is then followed by the Square
portion.
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.
P
Status screen - Displays the current operations of the pump,
Press - To push and release a button.
including active functions, the most recent basal and bolus
deliveries, reservoir information, and battery condition.
Prime - (see fixed prime or manual prime)
R
Suspend - Function that stops all insulin delivery. Any current
bolus delivery is canceled. The basal delivery is paused until
restarted.
Resume - Restarts basal delivery after the pump is suspended.
T
PSI - Pound-force per square inch
Rewind - The pump drive moves back to its starting position to
prepare the pump for a new reservoir.
Temp - Temporary
Temp basal - (Tmp basal) Temporary one-time basal insulin
S
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.
Scroll - Press the up or down arrow buttons to move through
the screen text.
U
Select - Pressing the up or down arrow buttons to highlight a
desired screen item.
μL – microliter
9
Your personal information
You may need the following information from your healthcare professional before going to your pump start appointment. If you are unsure,
contact your healthcare professional or pump trainer for instructions.
NOTE - This information is not for the Bolus Wizard. Refer to chapter 5 for Bolus Wizard settings.
Basal rate
Basal insulin is required to maintain your target glucose values when you are not eating. Your pump can be programmed with up to three
(3) basal schemes (scheme 1, scheme 2, scheme 3) to accommodate your varying insulin needs on different days (example: weekday
versus weekend day) . Each pattern can have up to 24 basal rates. When you first start pump therapy, you may only have to program one
or two basal rates. Get your basal rate settings from your healthcare professional.
Scheme 1
Scheme 2
Basal rate
Start time
number
#1
midnight
#2
#3
(additional basal rates)
#4
#5
#6
#7
#8
Basal rate
(units per hour)
Basal rate
Start time
number
#1
midnight
#2
#3
(additional basal rates)
#4
#5
#6
#7
#8
Scheme 3
Basal rate
Start time
number
#1
midnight
#2
#3
(additional basal rates)
#4
#5
#6
#7
#8
10
Basal rate
(units per hour)
Basal rate
(units per hour)
Insulin type
The insulin type is U100 fast acting.
My insulin type is:
Carb ratios (meal bolus info)
When
Your carb ratios are used to calculate your meal boluses.
If you count grams: this ratio is the number of carb grams covered by one (1)
unit of insulin.
(grams/u or u/exch)
breakfast
lunch
If you count exchanges: this ratio is the number of insulin units you need to
cover one carb exchange.
dinner
BG targets
When
BG targets are the levels that your BG (blood glucose) should be and are
required for pump therapy. Keeping your BG within target range is important
for living well with diabetes. Your healthcare professional should help you
determine these targets.
U100 fast acting
snacks
BG Target
(mg/dL or mmol/L)
before meals:
2 hours after meals
bedtime:
before driving:
Insulin sensitivity
Your insulin sensitivity value indicates how much your blood glucose is
reduced by 1 unit of insulin. Your insulin sensitivity values are used to
calculate your correction boluses for high BG.
11
1 unit of insulin will lower my BG:
mg/dL or
mmol/L
Introduction
Thank you for choosing TruCare as your partner in helping you gain better control of your diabetes.
The pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons
requiring insulin.
Purpose
This user guide is designed to help you to understand pump therapy and the operation of your pump. We strongly recommend that you
work closely with your healthcare professional for a safe and complete pump start.
Your pump is for insulin therapy to help you maintain a stable blood glucose target throughout the day. Based on your settings, the pump
delivers your custom basal automatically and continuously 24-hours a day. It also provides bolus deliveries to support your immediate
insulin needs for food intake and/or high blood glucose. The Bolus Wizard feature can calculate your bolus amount for you based on your
personal settings.
12
How to use this guide
NOTE - This user guide shows sample screens only. The screens in this user guide may be slightly different than your actual
pump screens.
For step-by-step instructions, refer to the applicable sections in this guide. Refer to the Glossary for definitions of terms and functions.
The terms and symbols used in the step-by-step instructions are in the table below.
Term / symbol
Meaning
“Press”
to push and release the button
“Select”
to press
/
to highlight a screen item you want to select
“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, PRIME MENU screen
Menu selections
always bold; for example, On, Off
flashing (blinking)
screen item
you can change the value for that item with the
NOTE:
additional helpful information for the preceding text
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
“Go to the...screen.”
/
buttons
When a step instructs you to “Go to” a screen, the path to that screen is shown.
For example:
Go to the Alarm MENU.
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.
13
Chapter 1
Before you begin. . .
Availability
The pump and accompanying products are available from Apex Medical and authorized distributors.
Assistance
Apex Medical provides a 24-hour Product Help. Line for assistance.
The Help Line is staffed with technicians who are trained in the set-up
and operation of the pump and are able to answer pump-related
questions. When calling the Help Line or your local Apex Medical office,
please have your pump and serial number available. The phone
number for the 24- hour Product Help Line is also on the back of your
pump.
Department
Telephone number
24-hour Product Help Line
86-510-80100606
Web site
www. apexdiabetes. com
Emergency kit
Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Inform a family member, co-worker,
and/or friend where this emergency kit is kept. Please refer to chapter 11, “User safety” for more information on pump safety. Your
emergency kit should include these items:
◆
◆
◆
◆
◆
Fast-acting glucose tablets
TruCare Quick Reference Card
Blood glucose monitoring supplies
Dressing and adhesive
Urine ketone monitoring supplies
◆ Glucagon Emergency Kit
◆ Extra infusion set and reservoir
◆ Extra AAA Alkaline batteries
◆ Insulin syringe and fast-acting insulin (with dosage
instructions from your healthcare professional)
14
Disposables
The pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions for reservoirs and infusion sets are
provided in chapter 4.
◆ Reservoirs: The TruCare pump is intended for use with a 300-unit reservoir .
◆ Infusion sets: Apex Medical provides a variety of infusion sets to fit your needs.
WARNING: For your protection the pump has undergone extensive testing to confirm appropriate operation
when used with reservoirs and infusion sets manufactured or distributed by Apex Medical. We recommend
using infusion set 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.
The insulin pump is an independently using system; it can be used with accessories and disposables which are
recommended by the manufacturer and it absolutely can’t be connected with other infusion system and
accessories.
Practice, practice, practice. . .
Before you begin pump therapy, it is important that you become familiar with your pump.
Do
Do NOT
◆ Read this book
◆ DO NOT install a reservoir into the pump while you are
◆ Complete the practice exercises in this book (Refer to the
practicing
table of contents for a list of practice exercises.)
◆ DO NOT, under any circumstances, begin insulin therapy
◆ Explore and navigate the pump menus
without guidance from your healthcare professional
◆ Practice programming a bolus
◆ Practice programming a basal rate
If you press rewind by mistake
Rewind is part of the process that takes place with every infusion set change. You will learn about this in
Chapter 4, “Starting on insulin” and at your pump training.
If you press “Rewind” by mistake, do NOT insert the reservoir in your pump.
Remember,
do NOT use a reservoir with insulin until you have been instructed to do so by your healthcare professional.
15
Chapter 2
The basics. . .
Your pump
CAUTION: Never use sharp objects to press the buttons on your TruCare 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, paperclips, knives, scissors, and keys.
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.
TruCare pump shown;
16
Install battery
CAUTION: It is highly recommended that you use an AAA alkaline battery. Do not use a carbon zinc battery in
the pump. Do not remove the battery unless you are changing your battery (installing a NEW
battery) . Replace it within 5 minutes, the screen may display alarm message. Install a new battery if
the battery was placed backwards in the pump. Recycling the used batteries is recommended to
protect environment.
Apex Medical 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 “failed battery test” alarm will sound. The pump uses one AAA alkaline battery.
It is important to change your battery regularly and to have spare batteries ready. The life of any battery is affected by how you use your
insulin pump, your personal settings, delivery rates, temperature, and other factors. The operating temperature of the battery must be
between 41°F and 104°F (+5°C and +40°C). The life of any battery is affected by how you use your insulin pump, your personal settings,
delivery rates, temperature and other factors. With typical pump use [50 U/day using U100 insulin; operating temperature 72°F ± 6°F
(22°C ± 3°C)], pump battery life is about two weeks using alkaline battry.
1. 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.
2. Use the edge of a quarter to remove the battery cap. Turn the cap in a counter-clockwise direction.
3. Remove the old battery. Put the new battery in the pump with the negative end [ (-) symbol] going in first. Check the label on the back
of the pump to make sure the battery is inserted correctly.
NOTE - Do not use batteries that have been in cold storage (i.e., in the refrigerator or your car in the winter) .
4. Place the battery
cap on the pump so
that the slot is aligned
in the orientation
shown here:
17
5. Turn the battery cap clockwise 3 turns so
the slot is aligned horizontally with the pump
as shown here:
Do NOT apply force when you turn the cap.
CAUTION: Do NOT over-tighten the battery cap. You should not turn the cap more than three (3) turns. If you
over-tighten the cap you may not be able to remove it, and you can damage your pump.
6. While the pump turns on, it will show various screens
until the HOME screen appears.
Apex Medical
(HOME screen)
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 a NEW battery.
b. If your pump still does not turn on or you get a FAILED BATTERY TEST alarm, remove and replace the battery with a new one.
c. If the pump is still not on, call the Apex Medical 24-hour Product Help Line.
7. Check to make sure the time and date are correct. If this is the first battery installed, or if more than 5 minutes have passed since you
removed the battery, you must program the time and date. Refer to the section, “Setting the time and date” in chapter 3 for programming
instructions.
8. Press ESC to view the STATUS screen, making sure no alarms are active. If an alarm is active, follow the instructions on the screen.
18
Pump buttons
The buttons on the pump are
used to navigate through the
menus and screens, and to
program the features of the
pump.
TruCare pump shown
From the HOME screen. . .
Turns the backlight on/off.
Opens the MAIN MENU.
(express bolus button) Short-cut to the BOLUS MENU to setup any bolus type
Opens the STATUS screen. From the menus and programming screens. . .
/
Increases / decreases the value of a flashing item.
/
Scrolls up and down the items in a list.
Accepts a selected menu item or activates a selected setting.
Returns the screen to the previous screen.
Backs out of an unintentional menu selection, if the ACT button has not been pressed yet.
19
The pump screen
The screen shows five lines of text at one time. The first is the operating mode. The second is the current open menu or function. The last
three lines show either information or text that you can select for the current function.
NOTE - The screen text in the examples used in this guide might not exactly match the text on your pump screen. Please follow
your pump screen instructions. If you have any questions, call the Apex Medical 24-hour Product Help Line.
Is my pump on?
When the pump is on, the word “Apex
Medical” appears across the top of the
screen. If “Apex Medical” does not appear,
the pump is not operating.
Apex Medical
indicates
the pump is
operating
Scroll bar
If there is more text than the screen can show,
a scroll bar appears in the right side of the
screen. Press
to view any additional text.
Screen backlight
When you press
from the HOME screen, the light on the screen turns on or off. During programming, the light will stay on while you
are pressing any of the pump buttons. It will turn off automatically 15 seconds after the last button is pressed.
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.
Beep/vibrate
Your pump will beep or vibrate to indicate activity. Refer to the section, “Setting your alert type” in chapter 8 for setup instructions.
20
HOME screen
The HOME screen serves as the starting point to access the programming screens. When no buttons are pressed for about 15 seconds,
the pump returns to this screen.
When you press ACT from the HOME screen, the MAIN MENU will appear.
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 below.
Normal - mode for standard pump operations for basal and
bolus delivery. No special features are active (i.e., temp
basal, etc.). No alarms and no alerts exist.
Special - 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, “Apex
Medical” appear across the top of the screen and it will
beep/vibrate periodically to remind you of the condition. The
conditions and features that will put the pump in Special
mode are:
‹
‹
‹
‹
‹
Low Reservoir condition
Low Battery condition
Block feature is on
Bolus delivery
Temporary basal delivery
21
Attention - indicates insulin delivery has stopped. Either an
alarm is active or an alarm condition exists that needs
immediate attention for insulin delivery to resume. “Apex
Medical” appear across the top of the screen and the pump will
bee p/vibrate periodically until 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.
When the pump is in Attention mode, it will beep/vibrate periodically to remind you of the condition. The beep/vibrate frequency varies
depending on the condition that caused the alarm. Refer to the section, “Alarm conditions” in chapter 9 for the conditions that will trigger
the Attention mode.
When the pump is in “Attention mode, ” all insulin deliveries are stopped.
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. A diagram of the menu structure is at the back of this user guide.
TIP - If a screen item is flashing (blinking) , during programming, press
/
to change the value.
MAIN MENU - Highest menu level in the menu system. When you press ACT from the HOME screen, the MAIN MENU will appear.
BOLUS MENU - Contains the settings and function for bolus deliveries. The
without having to navigate through the menus.
button allows direct access to the BOLUS MENU
SUSPEND - Stops all current insulin deliveries (basal, bolus) . Refer to section, “Stopping your pump” in chapter 3 for more information.
BASAL MENU - Contains the functions to setup and deliver your basal. Refer to the section, “Basal” in chapter 3 for more information.
PRIME MENU - Contains the functions required to change your reservoir and fill the infusion set with insulin. Refer to the section,
“Changing your infusion set” in chapter 4 for more information.
UTILITIES MENU - Contains features for your safety and convenience. Refer to chapter 8, “Utilities” for more information.
22
STATUS screen
The STATUS screen shows information about what your pump is doing. The information that shows on the STATUS screen depends on
the current activities and conditions of your pump. The screen includes information about:
‹
‹
‹
reservoir status
recent insulin deliveries (basal and bolus)
special feature that are turned on
‹
‹
time and date
battery status
Refer to chapter 12, “Specifications” for a complete list of the
information that is available in the STATUS screen.
‹
To open the STATUS screen... Press ESC until the STATUS
screen appears.
‹
To view more text on the STATUS screen...Press
to scroll and view screen information
‹
To exit the STATUS screen ...Press ESC until the STATUS
screen disappears.
/
NOTE - Only check your pump status (press ESC) when you
are not programming your pump.
Sample STATUS screen
23
Alert conditions
Your pump has a sophisticated network of safety checks and systems. If it detects an unusual condition that requires your immediate
attention, it will beep or vibrate periodically to alert you. Additionally, the alert message will appear on the screen.
What to do...
When your pump beeps or vibrates notifying you that an alert condition exists:
1. Read and follow the instructions on the screen. Press ESC、ACT to silence an alert.
2. Check the STATUS screen to determine what caused the alert.
3. If the condition is due to a low battery, replace the battery.
4. 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.
Low inslin
If you get this alert, prepare for infusion set and reservoir and
fast-acting insulin. Before changing your infusion set, clear
(ESC、ACT) this alert and rewinding.
Low battery alert
If you get this alert, DO NOT go to sleep without replacing the
battery. The backlight is disabled during a LOW BATTERY
condition. If the alert type is set to “vibrate, ” the pump will
change to the “beeps”. Clear (ESC、ACT) this alert before you
replace your battery.
Apex Medical
15:38
LOW BATTERY
Press ESC,ACT to Clear
24
Alerts for special features
Some features put the pump in Special mode, letting you know that an extended feature is active. When the feature is no longer active,
the pump will return to Normal mode. Your pump will alert you if any of these extended features are active:
‹
‹
‹
Bolus delivery
Temp basal delivery
Block feature is on
If you remove your pump. . .
Pump settings
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 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) .
NOTE - Your pump keeps a record of the basal and bolus insulin it delivers. Setting your basal to 0.0 while you are
disconnected ensures the insulin delivery records in your pump are accurate.
Insulin
Remember, your body still needs insulin while your pump is removed.
You can remove your pump for up to one (1) hour without taking insulin. If you remove your pump for more than an 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 (4) hours. Calculate the amount of insulin to take based on the total of your basal insulin in
four (4) hours. Include the boluses. If you will have your pump off for several days, you will need to return to a multiple injection regimen.
It is important that you consult you’re your healthcare professional to determine an alternate method of receiving your insulin.
25
Chapter 3
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.
1. Go to the TIME/DATE SETUP screen.
Main > Utilities > Time/Date
2. Select Time/Date and press ACT, display the pump’s date/time.
3. Press ACT again to change the settings.
4. Change each of the settings as follows:
Year
Month
Apex Medical
SET YEAR
Day
Apex Medical
SET MONTH
2010
07
Chang the day. Press ACT.
Chang the day. Press ACT.
Chang the day. Press ACT.
Hours
Minutes
Seconds
Apex Medical
SET HOUR
15 56 58
flashing
Chang the day. Press ACT.
Apex Medical
SET MINUTE
Apex Medical
SET SECOND
15 56 58
flashing
15 56 58
flashing
Chang the day. Press ACT.
26
Chang the day. Press ACT.
BG reminder
When you deliver a bolus you may want to check your BG afterwards. The BG reminder is an optional feature that beeps or vibrates to
remind you to check your blood glucose after a bolus. Your pump is set at the factory with this feature turned off. If the BG reminder is on,
during bolus programming your pump will ask for the amount of time you want to be reminded after your bolus delivers. This time can be
from 30 minutes to 5 hours, or NONE. If you do not want to use the BG Reminder at all, set the option to off.
1. Go to the BG REMINDER SETUP screen.
Main > Bolus > BG Reminder
2. Select On and press ACT. The BG reminder is now enabled.
Exit the menus.
Apex Medical
BG REMINDER SETUP
Off
On
The next time you program a bolus, your pump will ask you for “NONE” after your bolus when you want to be reminded to check your BG.
NOTE - If you press ACT when the BG Reminder Duration screen appears, your pump will begin delivering the bolus without
setting a reminder. If you program another bolus with a BG reminder before a previously scheduled BG reminder goes off, the
previous BG reminder will be canceled.
When the BG reminder goes off, your pump will beep or vibrate and the message “CHECK BG” will appear on the screen. Your pump will
beep or vibrate periodically until it is cleared (ESC, ACT) .
27
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 chapter 6,
“Optimizing pump therapy. ”)
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.
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 the target
that was chosen for you.
The following instructions are for a Normal bolus without the Bolus Wizard.
from the menu, or
1.Go to the BOLUS MENU.
Main > Bolus
Select Set Bolus and press ACT. Go to step 2.
using the EXPRESS BOLUS button
Press
on your pump. Go to step 2.
If the BOLUS TYPE screen appears:
(Dual/Square Wave is on)
Select Normal Bolus and
press ACT. Go to step 3.
2.If the SET BOLUS screen
appears:
(Dual/Square option is off)
Go to step 3.
3.Enter your bolus amount and
press ACT.
“SET NORMAL BOLUS” will
show if Dual/Square option is on.
28
4.Press ACT to accept and deliver
the bolus. The Normal bolus will
start. As the bolus delivers, the
amount shown on the screen will
increase until the entire bolus has
been delivered
NOTE - The pump will beep/vibrate at the start of the bolus.
When the bolus is finished, the pump will beep/vibrate again and the HOME screen will appear.
Example #1
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
1 small apple
1 cup of non-fat milk
2 starches
1 fruit
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:
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. □
29
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.
Example #2:
Normal meal bolus using carbohydrate counting
Lydia has been taught that she needs to take 1 unit of insulin for every 10 grams of carbohydrate. This is her insulin to carbohydrate
ratio. For dinner she will have:
4 oz. broiled chicken
2/3 cup of rice
½ cup cooked broccoli
1 oz. Dinner roll
1 tsp Margarine
0 grams
30 grams
5 grams
15 grams
0 grams
───
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) .
30
Normal meal bolus practice using carbohydrate counting:
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.
Example #3:
Meal bolus, correction bolus and insulin sensitivity
3a.
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 mmol/L) . Jason knows that his blood glucose level is above his pre-meal
blood glucose target and will need additional insulin before he eats.
Jason's healthcare professional has determined the following for him:
pre-meal target BG: 110 mg/dL (6. 1 mmol/L)
*Insulin sensitivity: 30 mg/dL (1. 7 mmol/L)
3b.
Jason determines that he will need a correction bolus of 3. 0 units insulin to lower his elevated blood glucose. The 3. 0 correction bolus
will lower his current BG of 200 mg/dL (11 mmol/L) to his pre-meal target of 110 mg/dL (6. 1 mmol/L) .
elevated blood glucose: 200 - 110 = 90 mg/dL (11 - 6. 1 = 5 mmol/L)
correction bolus: 90 / 30 (insulin sensitivity) = 3. 0 units
(He will add this 3. 0 correction bolus to the 4. 0 units of insulin that he will need for his meal bolus.
Jason will take a total bolus of 7. 0 units. )
* Insulin sensitivity should equal the amount (in mg/dL or mmol/L) that blood glucose will be lowered after taking 1 unit of insulin. To
determine insulin sensitivity, divide 1500 by Total Daily Dose (TDD**) of Insulin. The answer is your “Correction Factor”
(1500 Rule) . As always, consult with your healthcare professional for guidance.
**TDD = Total amount of basal and bolus insulin delivered in a 24-hour day.
31
Practice: Meal bolus
You have determined your meal bolus as: _______ units.
Your pre-meal 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 BG _________.
You will take ________ unit (s) of insulin to correct your high BG level.
Your total bolus (meal bolus plus correction bolus) is _________.
32
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 32 boluses. This feature is helpful for record keeping or to check if you bolused for your last meal.
Do the following steps to view the BOLUS HISTORY screen:
1. Go to the BOLUS HISTORY screen.
Main > Bolus > Bolus History
Scroll through the bolus deliveries.
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 maximum bolus amount.
To set the maximum bolus limit, do these steps:
1.Go to the MAX BOLUS SETUP screen.
Main > Bolus > Max Bolus
2.Set your maximum bolus limit and press
ACT.
3.Your maximum 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.
33
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 should account for approximately one half of the body’s total daily insulin requirements. Your pump mimics
your pancreas by delivering insulin continuously over 24-hours.
You can set your insulin pump to change rates during the day to match your needs. Your needs depend on your lifestyle and insulin
requirements. Some people only use one rate throughout the day, while others find they need more. Your basal rates are made up of
insulin deliveries that have start and stop times. Once set, these rates make up your 24-hour basal pattern and are repeated daily.
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 stop time
is the time that one basal rate stops and the next basal rate
starts (see figure).
It is recommended that you record your basal rates on paper.
The Quick Reference card is provided with your pump for this
purpose. For best results, setting or changing your basal rate
(s) should be discussed with your healthcare professional.
* For Basal Rate 1, the start time cannot be changed (only
the rate can be changed) . Basal Rate 1 always starts at 12 a.
m. or 00: 00, depending on the time format selected.
* 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.
*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.
34
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 0.0U/H. This will ensure that
the insulin delivery records in your pump are accurate. Refer to the section, “If you remove your pump” in chapter 2 for more information.
Basal programming and delivery
To set your basal rates, do these steps:
NOTE - You cannot make changes to your basal rate settings while a percent (%) temp basal
is active.
1. Go to the BASAL MENU.
Main > Basal
2. Select Set/Edit Basal and press ACT.
3. The SET BASAL RATE 1 screen will appear.
Enter your first basal rate amount and press ACT.
NOTE - The start time for your first basal rate is midnight
(00:00) and cannot be changed.
4. The screen will change to SET START TIME 2. If you only
need one basal rate for the entire 24-hour day (00:00 to 24:00) ,
do these steps:
a. Press ACT or ESC without setting a start time.
b. The BASAL RATE screen will appear with your basal data.
Your daily basal rate is now programmed. It will deliver daily from
00:00 to 24:00.
c. Exit the menus.
If you need to program more than one basal rate for the day, do these steps:
a. In the SET START TIME 2 screen, enter the start time for the next rate and press ACT.
35
b. The SET BASAL RATE 2 screen will appear. Enter the rate and press ACT.
c. Repeat steps a and b for each additional basal rate. Each rate will have a different number (i.e. Basal Rate 1, Rate 2, Rate 3, etc.) .
d. After you program your last basal rate, press ESC.
e. The BASAL RATE screen will appear. Your basal rate (s) will now deliver as programmed. Exit the menus.
Practice: Basal programming
Make sure you are NOT connected to your pump while practicing.
Set a basal rate of 0. 5 unit per hour.
Check here if you were able to set the basal rate: □
What is the total basal insulin for 24-hours? ______ (answer: 12 units)
36
Basal review
Temporary basal information is only available in the STATUS screen.
Current basal delivery
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 (00:00 to 24:00). Compare
your daily insulin deliveries to your blood glucose records to help you and your healthcare professional identify your optimal daily insulin
rate (s) .
1. Go to the BASAL MENU. Select Basal Review
and press ACT.
Main > Basal
Apex Medical
BASAL MENU
Select Basal Scheme
Temp Basal Type
Basal Review
2. Scroll through the bolus deliveries.
3. Exit the menus when you are done.
37
Max basal rate
Maximum basal rate is a safety limit for the amount of basal insulin that is able to be delivered per hour. This maximum rate will apply to
every basal that is set, including a temporary basal. It is important to discuss what your max (maximum) basal rate should be with your
healthcare professional.
Your pump is sent from the factory with the maximum basal set to two (2. 0) units per hour. Once your basal rates have been set, you
CANNOT set a maximum basal that is less than any of the programmed basal rates –this includes patterns and temporary basal rates.
To set your max basal rate, do these steps:
1. Go to the MAX BASAL RATE
2. Change the rate and
screen.
press ACT.
Main > Basal > Max Basal Rate
3. Your maximum 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.
38
Stopping your pump
You can stop your pump with the suspend function. Suspend stops all insulin delivery including the current basal and any bolus deliveries
that are in progress. While suspended, your pump will not deliver insulin until you Resume your pump. When basal is resumed, the pump
is taken out of the Suspend mode.
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. The pump will beep/vibrate at 11:30, 11:45, 12:00, and so on until you resume your pump (basal resumes) .
NOTE - When suspended, your pump is in attention mode. When in Suspend, you can only resume your basal or view the
STATUS screen. No other functions are available.
Do these steps to suspend your pump:
1. Go to the Suspend screen.
Main > Utilities > Suspend
2. Select Suspend from the UTILITIES MENU, and press ACT.
3. SUSPEND will flash. Press ACT to stop your pump.
4. The screen will show that the pump is suspended and the time that it stopped. After a few minutes, the pump will default to the HOME
screen.
NOTE - Press ACT to view the screen and verify your pump is suspended.
39
Example:
Suspend function
1. Josh has been on a TruCare pump for several months. He is very active in soccer and basketball. He and his healthcare
professional have determined that he does not need his basal insulin during his games, and that he is able to take the pump off for
these short amounts of time. Josh uses the “Suspend” feature on his pump to stop the basal insulin during the time that he is
disconnected from his pump. He will “Resume” delivery when he reconnects the pump.
2. 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.
Practice:
Suspend function
1. 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.
2. Now, “Resume” delivery, so that your basal insulin will continue.
3. 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? _____.
40
Resume pump delivery
When the pump is suspended, it defaults to the HOME screen. Do these steps to resume your pump and basal delivery:
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.
Apex Medical
Stopped at 11:36
RESUME
3.
ACT-Restart Basal
NOTE - A bolus that was stopped by suspend will not restart when you resume your pump. You must reprogram and activate it
to finish delivery.
Practice:
Resume basal delivery after a suspend
Make sure you are NOT connected to your pump while practicing.
Give a 3. 0 unit bolus now. While it is delivering, suspend the bolus.
Check here if you were able to suspend the bolus? □
Now restart the pump.
Check here if you were able to restart the pump? □
41
Chapter 4 Starting on insulin
Prepare your pump for use
Before continuing with the steps in this chapter, we recommend that you complete your pump start training.
When you are done practicing and ready to use your pump with insulin, you must:
1. do a “Clear pump” function
2. set the time and date
3. program your settings as instructed by your healthcare professional.
Refer to the applicable chapters.
You will need these items:
◆ Pump
◆ Insulin
◆ Reservoir and user guide
◆ Infusion set and user guide
Refer to the sections in this
chapter.
4. install the reservoir, and
5. prime the infusion set.
Warning: The reservoir and infusion set are sterile products intended for single use only. Sterility is guaranteed for unopened
packaging up to the indicated expiration date. Do not use sterile products if the packaging is damaged.
Do not reuse single use materials because this might lead to a malfunction of your insulin pump, to incorrect insulin delivery, and/or an
infection. Always handle the items with clean hands. Avoid any contact of the infusion set and the connecting parts of your insulin pump
with antiseptics, antibiotic creams, soaps, perfumes, deodorants, body lotions, or any other cosmetics. They may contaminate these
parts.
Before you change the reservoir and infusion set, check that your pump is in good, working order.
Insulin can flow freely from the reservoir or infusion set if the reservoir and the piston rod are not properly connected and the pump is
positioned at a higher level than the infusion site. Prevent free flow of insulin by correctly inserting the reservoir : move the piston rod to
the proper position and twist the adapter until the reservoir flush with the end plate of the piston rod.
42
Filling the reservoir
WARNING: Your pump will not accurately deliver insulin if air bubbles are in the reservoir or the infusion set. To prevent this,
take care to remove air bubbles when filling your reservoir.
It is important that you change your Reservoir every 2-3 days
1. Wash your hands.
2. Set the insulin vial on a hard, flat surface, such as a table.
Clean the rubber membrane of the vial using an antiseptic wipe.
3. Remove reservoir from package.
4. Move the plunger rod back and forth twice in the reservoir
to distribute the lubricant.
Pull the plunger back to fill the reservoir with air.
Remove the protective cap from the needle. Do not touch
anything with the needle.
43
5. Push the tip of the filling needle into the center of the insulin
vial’s rubber membrane.
Push the plunger rod down so that all air from the cartridge enters
the insulin vial.
6. Hold steady pressure against the plunger rod with your thumb,
and at the same time turn the insulin vial over so that the filling
needle and reservoir are pointing upwards into the insulin vial.
Make sure that the tip of the filling needle stays in the insulin.
Slowly release the pressure against the plunger rod and let the
insulin flow into the cartridge. Do not pull or push the plunger rod
while it is moving on its own (this could lead to air bubbles in the
insulin)Slowly pull the plunger rod straight down to fill the
reservoir .Remove any air bubbles by tapping on the cartridge.
Push the air bubbles back into the insulin vial using the plunger
rod. The reservoir is full when there are no air bubbles in it and the
plunger is at the bottom of the reservoir.
7. Remove the filling needle from the insulin vial.
8. Place the protective cap on the filling needle.
Remove the plunger rod by turning it counter-clockwise out of the
plunger.
Remove the filling needle with its protective cap from the reservoir
by turning counter-clockwise. Dispose of properly.
Push the reservoir protective cap tightly onto the reservoir tip until it
clicks. The reservoir is now ready to use
44
Changing your infusion set
Removing the reservoir
Each time you remove and replace a reservoir in your pump, you have to rewind and prime your pump. Priming requires insulin.
1. Remove the entire infusion set from your body.
2. If attached, remove the activity guard.
3. Turn the tubing connector counterclockwise, then pull the
reservoir and connector out from the pump.
4. Safely dispose of the used reservoir and infusion set items.
5. You must now rewind your pump as described in the next section. tubing connector
45
Rewinding your pump
Before you continue, make sure the pump is NOT connected to your body.
WARNING:
Make sure the infusion set is disconnected from your body before you rewind or 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. If you removed your reservoir and are replacing it, go to the REWIND screen.
Main > Prime > Rewind
2. In the PRIME MANU screen, select Rewind, press ACT to start the rewind process. The REWINDING screen will appear while the
pump rewinds.
3. After the pump rewinds, the MANUAL PRIME screen will appear.
If you are practicing, do these steps:
a. Do NOT insert the reservoir in your pump.
b. Continue with the manual prime instructions described in the “Manual prime” .
If you are not practicing, continue to the next section, “Inserting the reservoir in your pump”.
46
Inserting the reservoir in your pump
If your reservoir is already inserted in your pump, continue to the next section, “Manual prime. ”
You must do these steps in the order described. Your pump screen will show instructions to help you with these steps. 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 measures the
reservoir volume. To ensure correct volume measurements, your pump has been designed to require a rewind
before you change your reservoir.
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.
3. You must now do a manual prime as described in the next section.
47
Manual prime
Manual prime fills the infusion set tubing with insulin before you attach it to the infusion site. Manual prime is only available after you
rewind your pump.
WARNING: Make sure 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. After you rewind your pump, the MANUAL PRIME screen will appear.
2. Press ACT to start the prime.
3. Until insulin droplets form on the tip of the infusion set needle, bend tubing anywhere, then stop. Be sure no bubbles are in the tubing.
WARNING: Your pump will not accurately deliver insulin if there are air bubbles in the infusion set. Take care to remove any air
bubbles during the manual prime.
If your manual prime uses more than 25 U insulin, the pump
will ask you, “complete?” If you get this message, do these
steps:
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. If your
manual prime is not complete, do not anything until priming is complete then continue to step 5.
4. Press ESC. Your manual prime is complete.
5. You can now insert the infusion set into your body as described in the next section.
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Insert 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
◆ confirm your insulin type and
◆ prime the pump (fill the infusion set with
insulin)
It is important that you change your infusion set every 2-3 days. Apex Medical offers a number of different infusion sets for your pump.
Instructions for the infusion set begin on the next page as an example. Always refer to the instructions that shipped with your infusion set.
After your infusion set is inserted, continue to the section, “Fixed prime. ”
Infusion set
Instructions are also included with the infusion set.
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50
Connecting
If you inserted a new reservoir, you should have already done a manual prime. A manual prime is always done to fill the infusion set
tubing with insulin after you rewind your pump and insert the reservoir. If you are changing your infusion set without changing your
reservoir, do a fixed prime to fill the tubing. Refer to the section, “Fixed prime” on the next page for instructions.
Place the connector part (flat-side facing down) on the infusion set until it is fully seated.
Do not grip the connector part by the flat side-grips.
51
Disconnecting
52
Fixed prime
A fixed prime fills the soft cannula with insulin and is required after the infusion set is inserted into your body. You will start the fixed prime
after the introducer needle is removed. Additionally, a fixed prime is required if you disconnect your quick release and you need to
reprime the infusion set or if you change your infusion set without changing the reservoir.
NOTE - Prime amounts depend on the type of infusion set you are using. Refer to your infusion set instructions for your fixed
prime amount.
1. Go to the PRIME MENU.
Main > Prime > Fixed Prime
3. In the FIXED PRIME screen, enter the
amount for infusion set, then press ACT.
2. Select Fixed Prime and press ACT.
4. Once the prime begins, the PRIME
DELIVERY screen will count up the units as
they are delivered. A “beep” will sound when
priming is complete.
Prime history
Do these steps to see a list of the delivered primes.
1. Go to the PRIME MENU.
Main > Prime
3. The PRIME HISTORY screen will
appear.
2. Select Prime History and press ACT.
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4. Scroll through the list of prime deliveries.
The “F” at the end of the text line indicates
a fixed prime An “M” indicates a manual
prime.
Record keeping for diabetes management
Now that you are using the pump with insulin, we will be asking you to test your blood glucose regularly. The information from your blood
glucose journal is your healthcare professional's only method of making adjustments in your pump settings. It is important to test often
and write down your blood glucose readings, the food you eat, any exercise you perform and any other notes to explain your blood
glucose results.
You must test at the recommended times and any other time that you feel your blood glucose is high or low. Be sure to include your meal
boluses, correction boluses, the amount of carbohydrate you eat, basal rate and any other information that will be helpful in assisting
your healthcare professional in adjusting your pump settings.
It is very important to look at your blood glucose readings as feedback regarding your diabetes management, not as statements about
you or your self-worth. Try not to have an emotional reaction to the numbers and do not judge them too harshly. You will soon learn how
to modify the numbers easily and precisely through insulin pump therapy.
TEST AT LEAST 4-6 TIMES A DAY.
These are the recommended times to test to determine control:
◆
◆
◆
◆
◆
Overnight (occasionally, at approximately 2 - 3 AM)
Pre-breakfast (fasting)
Post-breakfast (approximately 2 hours after eating)
Pre-lunch
Post-lunch (approximately 2 hours after eating)
◆
◆
◆
◆
Pre-dinner
Post-dinner (approximately 2 hours after eating)
Bedtime
Before driving
Determining your pump settings
Your healthcare professional will use your daily blood glucose journal records to program your pump. It is very important to keep good
records during the first weeks after you start on pump therapy. Not only must you record your blood glucose readings, but it will be
important to eat regularly scheduled meals and to keep your activity as consistent as possible.
Until you and your healthcare professional determine the pump settings that will work best for you, it is important to eat meals for which it
is easy to count the carbohydrates. After your correct basal rate is determined, you will be able to experiment with varied food choices
and amounts.
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.
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Using your daily journal
To use the daily journal that came with your pump, follow these easy steps:
1. Write the day and date in the spaces provided on the top of the page.
2. Find the time of the entry you are making. Test your blood glucose and enter the value in the space labeled “blood glucose. ”
3. If you are eating at this time, write the grams of carbohydrates in the space labeled “carbohydrates“.
4. If you are taking a correction and/or meal bolus, record it in the space labeled “meal bolus” and/or “correction bolus”. Even if you
have added these together to take one bolus, write the separate amounts in the corresponding spaces.
5. Record your basal rate in the space labeled “basal rate”. If you have more than one rate, be sure to record the rate in the space
corresponding to the correct time for each rate.
6. When you exercise, write the minutes in the space labeled “exercise”. If you test your urine ketones, write the result in the space
labeled “urine ketones”. Each time you test your ketones, write the result even if it is negative.
7. Record the time you change your infusion set in the space labeled “set change. ” This notation will help you to evaluate any changes
in your blood glucose readings due to changing your infusion set.
8. Record the food you eat in the “breakfast”, “lunch”, and “dinner” columns.
9. In the “notes” section, write down any information that may explain your blood glucose values or diabetes management decisions.
Use this section as you would a personal journal.
10. At the end of the journal, there are blood glucose graphs. To draw your blood glucose graph for the day, find the time you tested and
follow the line up until you reach the corresponding blood glucose on the left. Once you find it, mark a dot on the graph that
corresponds to the correct time and blood glucose value. At the end of the day, connect the marks and draw your graph. This graph
will be helpful in looking at patterns in your blood glucose values from day to day.
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Chapter 5
Using Bolus Wizard
What is it?
The Bolus Wizard is an optional feature of the pump that calculates an estimated bolus:
Information you need. . .
Food entry
You need to know how many exchanges or grams of carbohydrates you are going to eat. (You need to know what foods contain
carbohydrate and understand carbohydrate counting. )
Your BG reading
You need to know your BG reading and enter your BG.
Your personal Bolus Wizard settings
In addition to your BG reading and/or your food entry, Bolus Wizard uses personal settings that you enter during Bolus Wizard
programming. (Instructions are in the section, “How to program Bolus Wizard. ”) .
◆
◆
◆
◆
◆
Carb units (grams or exchanges)
Carb (food) ratios (in carbohydrate grams/unit of insulin or insulin units/carb exchanges)
BG units (mg/dL or mmol/L)
insulin sensitivity
target blood glucose
You should get this information from your healthcare professional. Also, for best results, talk to your healthcare professional before
making any changes. Keep a record of your settings in the Bolus Wizard settings table on the next page.
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Make sure
you receive your Bolus Wizard settings
from your healthcare professional.
Bolus Wizard settings table
Name: ___________________ Date: __________
Refer to this table when you setup the Bolus Wizard as described in the section, “How to program Bolus Wizard. ”
Information
Setting
Carb units:
select: _____ Grams or _____ Exchanges
grams / unit or
insulin units/exch
Carb ratios:
Bolus Wizard uses this for your food bolus calculations.
#1: _________
#2: _________
If you count carbs:
this ratio is the amount of carbohydrate grams covered by one (1)
unit of insulin.
#3: _________
range: 3 – 75 grams/unit
(additional settings, if needed)
If you count exchanges:
this ratio is the amount of insulin you need to cover one (carb)
exchange.
#4: _________
#5: _________
range: 0. 2 – 5. 0 units/exchanges
#6: _________
NOTE - Your carb ratios may vary throughout the day. Your
pump allows you to program up to eight (8) different carb
ratios, if needed.
#7: _________
#8: _________
BG units: (how you measure your BG)
select: _____ mg/dL or ____ mmol/L
57
start time
(midnight)
Bolus Wizard settings table (continued)
Name: ___________________ Date: __________
Information
Setting
BG units reduced /
1 unit of insulin
#1: _________
Insulin sensitivity:
Bolus Wizard uses this ratio for your correction bolus calculations.
start time
(midnight)
#2: _________
#3: _________
This ratio is the BG units reduced by 1. 0 unit of insulin
(additional settings, if needed)
range: 10 – 250 mg/dL or
0.5 – 13.9 mmol/L
#4: _________
#5: _________
NOTE - Your insulin sensitivity may vary throughout the day.
Your pump allows you to program up to eight (8) different
insulin sensitivities, if needed.
#6: _________
#7: _________
#8: _________
mg/dL (mmol/L)
#1: _________
#2: _________
BG target:
(your optimum BG value)
range: 80 – 160 mg/dL or
4.4 – 8.9 mmol/L
#3: _________
(additional settings, if needed)
#4: _________
NOTE - Your pump will allow you to program up to eight (8)
different BG targets, if needed.
#5: _________
#6: _________
#7: _________
#8: _________
58
start time
(midnight)
How the Bolus Wizard works
If you are going to eat and you want
Bolus Wizard to estimate your food bolus:
Enter your food intake (carbs or exch)
and/or
If you believe your BG is high and you want
Bolus Wizard to estimate your correction bolus:
Enter your BG Reading
More about Bolus Wizard. . .
About maximum delivery
Bolus Wizard will not deliver more than the limit set for your maximum bolus. If Bolus Wizard 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. In the MAX BOLUS EXCEEDED
screen, press ACT to continue your
bolus programming. The estimate and
maximum bolus amounts will appear
for your information. Continue to step
2. If you do not want to continue,
press ESC to cancel and the screen
will return to the ENTER BG screen.
2. In the EST: MAX screen, press ACT
again to continue your bolus
programming. If desired, press ESC
to cancel and the screen will return to
the ENTER BG screen.
NOTE - Your pump will only deliver up to your maximum bolus limit setting. For example: The Bolus Wizard estimate is 30 units
and your max bolus limit is 25 units. When you press ACT, your pump will only deliver 25 units.
59
About active insulin
Bolus Wizard will use your BG reading and/or your food intake to calculate a suggested bolus based on your personal settings (target BG,
insulin sensitivity and carb ratio) . Additionally, it will consider any active insulin still in our body from prior bolus insulin deliveries.
Four to six hours after a bolus, the majority of
insulin has been bsorbed, but a very small
amount is active for a few more hours. The
olus Wizard automatically calculates this for
you and subtracts the ppropriate amount.
The details will appear in the ESTIMATE
DETAILS creen during the bolus
programming steps.
Apex Medical
ESTIMATE DETAILS
Est total:
4.0U
Food intake:
(Meter)BG:
45gr
180
Food:
3.0U
Correction:
2.0U
Active Ins:
1.0U
If there is no
active insulin,this
will show "N/A"
ACT to proceed,
ESC to back up
(values shown are for
example only)
Be assured that the calculated bolus amount is a conservative stimate to avoid low BG. You can override the suggested Bolus izard
estimate and manually enter a different amount.
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How to program Bolus Wizard
You need your personal settings from the Bolus Wizard settings table to setup the Bolus Wizard. Your Bolus Wizard 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 settings are in the next paragraphs. Program your settings in the order described to make
sure you program all the settings.
Bolus Wizard on/off
1. Go to the EDIT SETTINGS screen.
3. Select On or Off and press ACT.
Bolus > Bolus Wizard Setup > Edit Settings
4. The EDIT SETTINGS screen will
appear. Press ACT to program your
settings.
2. Select Wizard and press ACT.
Carb units
The carb unit setting lets the pump know which way to count your carbohydrates (grams or exchanges) . Refer to the “Bolus Wizard
settings table” for your carb ratio settings.
NOTE - Any time you make changes to the carb units, you must also reprogram the carb ratios.
61
2. Select Grams or Exchanges and
press ACT.
1. In the EDIT SETTINGS screen, select Carb
Units and press ACT.
3. The screen will return to the EDIT
SETTINGS screen so you can set your
carb ratios next.
Apex Medical
EDIT SETTINGS
Carb Units:grams
Carb Ratios: --
Carb/Exch ratios
If you use grams as your carb units: Carb ratio is the number of carb grams that are covered by one 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.
Because this ratio may vary throughout the day, your pump allows you to set up to eight (8) settings. Your healthcare professional may
only have you program one or two carb ratios when you first start using the Bolus Wizard feature.
4. In the EDIT SETTINGS screen,
using grams
using exchanges
select Carb Ratios and press ACT.
Apex Medical
Apex Medical
5. The screen will change to SET
EDIT SETTINGS
EDIT SETTINGS
CARB RATIO 1 (if you are using
Carb Units:grams
Carb Units:exch
grams) or SET EXCH RATIO 1 (if using
Carb Ratios: -Carb Ratios: -exchanges) . Set your first ratio and
press ACT.
ACT
ACT
Apex Medical
Apex Medical
SET CARB RATIO 1
SET EXCH RATIO 1
00:00
00:00
grams/U
U/exch
(The start time for your first ratio is midnight (00:00) and cannot be changed. )
NOTE - 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, this warning
message will appear on the screen. Press ESC to correct or ACT to continue.
62
6. To set just one ratio:
To set more than one carb ratio:
a. Press ESC.
a. Set the start time for ratio 2 and press ACT.
Apex Medical
SET START TIME: 2
--:-grams/U
b. Set the value for ratio 2 and press ACT.
c. Repeat steps a and b to set more ratios.
d. Press ESC when you are done.
Apex Medical
Apex Medical
(flashing)
SET START TIME: 2
SET START TIME: 2
--:--
--:-U/exch
grams/U
Apex Medical
SET START TIME: 2
--:-U/exch
Press
/ /
to set
Apex Medical
(flashing)
Press
/ /
to set
Apex Medical
SET CARB RATIO: 2
SET EXCH RATIO: 2
07:00
07:00
grams/U
U/exch
* Depending on how many ratios you set, this number can be 2
through 8.
7. The screen will return to the EDIT SETTINGS screen. Set your BG Units as described in the next section.
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BG units
You can select mg/dL or mmol/L as your Blood Glucose Unit (measurement type) .
NOTE - If you make changes to your BG units setting, you must reprogram your insulin sensitivity and BG targets.
8. In the EDIT SETTINGS screen, select
BG Units and press ACT.
9. Select mg/dL or mmol/L and press ACT.
10. The screen will return to the EDIT
SETTINGS screen to set your insulin
sensitivity next.
Apex Medical
EDIT SETTINGS
Card Units : 15
BG Units:mmol/L
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 amount may vary throughout the you’re your pump lets you set up to eight (8)
sensitivity settings. Your healthcare professional may only have you program one or two ins sensitivities when you first start using the
Bolus Wizard feature. Record your settings in the “Bolus Wizard settings table. ”
Insulin sensitivity values are normally between 20 – 100 mg/dL (or 1. 1 – 5. 6 mmol/L) . If your value is outside this range, a warning
message will appear on the screen.
1. In the EDIT SETTINGS screen, select Sensitivity and press ACT.
2. Enter the value for the first insulin sensitivity setting and press ACT.
Apex Medical
EDIT SETTINGS
BG Units:
mmol/L
Sensitivity:
2.5
BG Targets:
4.4
Apex Medical
ACT INS SENSITIVITY: 1
00:00
mmol/l
Unit INS
(flashing) set,then press ACT
NOTE - The start time for your first INS SENSITIVITY is midnight (00: 00) and cannot be changed.
64
3. The SET START TIME 2 screen will appear.
To set just one ins sensitivity:
To set more than one ins sensitivity:
a. Press ESC.
a. Set the start time for ins sensitivity 2 and press ACT.
Apex Medical
SET START TIME: 2
--:--
.
mmol/l
Unit INS
(flashing) set,then press ACT
b. Set the value for ins sensitivity 2 and press ACT.
c. Repeat steps a and b to set more values.
d. Press ESC when you are done.
Apex Medical
SET START TIME: 2
--:--
mmol/l
-.- Unit
INS
(flashing) set,then press ACT
4. The screen will return to the EDIT SETTINGS screen. You can now program your BG targets.
BG targets
The BG target setting allows you to set your pre-meal blood glucose targets. Because this amount may vary throughout the day, your
pump allows you to set up to eight (8) BG targets. Your healthcare professional may only have you program one or two BG targets when
you first start using the Bolus Wizard feature.
NOTE - BG targets are normally between 90 – 140 mg/dL (or 5. 0 – 7. 8 mmol/L) . If your targets are outside this range, a warning
message will appear on the screen.
1. In the EDIT SETTINGS screen, select BG Targets and press ACT.
2. Enter your first BG target and press ACT.
NOTE - The start time for your first target BG is midnight (12: 00A or 00: 00) and cannot be changed.
65
3. To set just one BG Target:
To set more than one BG Target:
a. Press ACT.
a. Set the start time for BG Target 2 and press ACT.
b. Set the value for Target BG 2 and press ACT.
c. Repeat steps a and b to set more BG Targets.
d. Press ESC when you are done.
* Depending on how many targets you set, this number can be 2 through.
4. The screen will display one of these messages:
◆ Bolus Wizard is on
◆ Bolus Wizard is off
Review your Bolus Wizard settings
Check your Bolus Wizard settings in the REVIEW SETTINGS screen. If necessary, compare this information with your information in the
Bolus Wizard settings table.
Bolus > Bolus Wizard Setup > Review Settings
In the REVIEW SETTINGS screen, scroll through the text to view your Bolus Wizard settings.
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Normal bolus using Bolus Wizard
After the Bolus Wizard is turned on and the settings are programmed, Bolus Wizard 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.
to deliver a Normal bolus at any time except during another Normal bolus. A Normal bolus will temporarily interrupt a Square
Use
Wave or Dual Wave bolus that is delivering. After the Normal bolus is finished, the Square Wave or Dual Wave bolus delivery will resume.
1. If you want a correction bolus, check your BG with your BG meter and go to step 2.
If you want to bolus for food, go to step 2.
2. Press
on your pump, or go to the BOLUS MENU, select Use Bolus Wizard, and press ACT.
3. The ENTER BG screen will appear.
Enter your BG value. Press ACT and continue to step 4.
If you are not entering a BG and want to bolus for food,
select the dashes in the ENTER BG screen. Press ACT
and continue to step 4.
4
In the ENTER FOOD screen.
if this is a food bolus:
if this is a correction bolus:
enter the food value you will eat and press ACT.
select 0 (zero) as the value and press ACT.
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5. Review the information in the ESTIMATE DETAILS
screen. Press ACT to continue to step 6. If you need to
make any changes, press ESC to return to the ENTER BG
screen (step 3) and make changes as necessary.
6. In the SET BOLUS screen, the estimated bolus amount
will show (flashing) . Change the amount if desired. Press
ACT to accept.
Apex Medical
ESTIMATE DETAILS
Est total:
4.0U
Food intake:
(Meter)BG:
Food:
180
ACT to
accept
3.0U
2.0U
Active Ins:
1.0U
ESC to back up
4.0 U
45gr
Correction:
ACT to proceed,
Apex Medical
ACT to
continue SET BOLUS
Apex Medical
BOLUS DELIVERY
10:13
0.1U
7. Press ACT to accept and deliver the bolus. The BOLUS DELIVERY screen will appear. The pump will beep or vibrate at the start and
end of the bolus. As the bolus is delivered, the screen will show the bolus type and amount until the total units have been delivered. The
screen will then default to the HOME screen.
Bolus Wizard examples
For the scenarios that follow, Michael has his Bolus Wizard turned on with the following settings:
Carb ratio: 15 grams per unit of insulin
Insulin Sensitivity: 40 mg/dL per unit of insulin
Target BG: 120 mg/dL
Example #1: Bolus Wizard
BG on target (normal BG)
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 Blood Glucose Monitor and his BG result of 120 mg/dL, and enters BG to his pump.
He estimates that his meal consists of 60 grams of carbohydrate. When prompted by Bolus Wizard, he enters this amount in the
ENTER FOOD screen. Based on his Bolus Wizard settings, the pump will suggest that he take 4. 0 units of insulin.
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Example #2: Bolus Wizard
BG above target (high BG)
The next day, Michael wakes up before school. Before eating the same breakfast, he tests his BG with his Blood Glucose Monitor and
finds it to be above his target at 200 mg/dL. He enters his BG to his pump.
When prompted by Bolus Wizard, 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.
(4. 0 for carbohydrate plus 2. 0 to correct his elevated BG) .
Example #3: Bolus Wizard
Blood glucose below target (low BG)
On another morning, Michael sits down before eating the same breakfast. He tests his BG with his Blood Glucose Monitor and finds it
at 80 mg/dL, which is below his target. He enters his BG to his pump.
When prompted by Bolus Wizard, 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. 0 unit of insulin.
(4. 0 for food minus 1. 0 to correct his BG that is lower than target) .
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Example #4: Bolus Wizard
Blood glucose above target (high BG) with active insulin
Michael is at school and wants to eat a snack in the late morning. He tests his BG with his Blood Glucose Monitor and finds it to at 200
mg/dl, which is above his target. He enters his BG to his pump. He estimates that his snack contains 60 grams of carbohydrate, so he
enters 60 into the pump when prompted by the Bolus Wizard. 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.
(4. 0 for food plus 2. 0 to correct his elevated BG, minus 1. 5 units of active insulin) .
70
Chapter 6
Optimizing pump therapy
Square Wave and Dual Wave bolus
Square Wave bolus delivers a bolus evenly over a specified 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 BG 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.
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.
Dual Wave/Square Wave bolus on-off
NOTE - 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. If the option is off, a Dual Wave or
Square Wave bolus cannot be programmed or delivered.
1. Go to the DUAL/SQUARE OPTION screen.
Main > Bolus > Dual/Square Bolus
2. Select On and press ACT. The feature is now on.
Exit the menus.
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Square Wave or Dual Wave bolus without Bolus Wizard
NOTE - To deliver a Square Wave or Dual Wave bolus, the dual/square bolus option must be on.
1. Make sure the dual/square option is on.
2. Calculate your food and/or correction bolus amount.
3. Press
on your pump, or go to the BOLUS MENU and select Set Bolus, then press ACT.
4. The BOLUS TYPE (or MANUAL BOLUS TYPE) screen will appear.
For a Square Wave Bolus do these steps:
For a Dual Wave Bolus do these steps:
a. Select Square Wave Bolus. Press ACT.
a. Select Dual Wave Bolus and press ACT. The SET DUAL BOLUS
TOTAL screen will appear.
The SET SQUARE BOLUS screen will appear.
b. Enter the desired amount for the total dual bolus units. Press
ACT.
b. Enter the desired amount for the
Square Wave bolus units and press
ACT.
to change the normal (Now)
c. In the next screen, press
and Square portions of the Dual Wave bolus. Press ACT. Notice
the screen also shows the percentage amount for each portion.
c. Continue to step 5.
d. Continue to step 5.
NOTE - The number of units you enter for the SET DUAL BOLUS TOTAL is a total of both the Normal and Square Wave bolus
units.
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5. The SQUARE DURATION screen will appear. Enter the amount of time you want the Square Wave bolus to last and press ACT.
6. The BOLUS DELIVERY screen will appear. The pump will beep or vibrate at the start and end of the bolus. As the bolus is delivered,
the screen will show the bolus type and amount until the total units have been delivered. The screen will then default to the HOME
screen.
Example #1: Square Wave bolus
Use of a Square Wave bolus while eating a meal high in fat
Conner loves pizza. When he was using insulin shots, he began to avoid pizza because he always had high blood glucose readings
several hours after eating this high fat meal. Now that Conner is using the TruCare pump, he can use the Square Wave bolus feature
to help with this problem. With frequent blood glucose testing and many pizza meals, he and his healthcare professional have
determined the length of time (duration) he needs to set his Square Wave bolus to prevent the high blood sugars after eating pizza. He
set it for 3-hours.
Example #2: Square Wave bolus
(gastroparesis)
Lisa has had diabetes for many years. She has been diagnosed with gastroparesis, a condition of the digestive system that slows
down the emptying of food from her stomach. This makes her carbohydrate digestion unpredictable. Because of this, Lisa has had a
lot of trouble with blood glucose control. It has been suggested to her that she use the Square Wave bolus feature before meals to
more evenly match her insulin with her carbohydrate digestion.
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Your turn:
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 (e. g. hot dogs, pizza, cheese enchiladas) . Determine your meal bolus amount. Set the Square
Wave bolus to deliver the determined amount of insulin over 2-hours*.
(* This duration time is an example. As always, consult with your healthcare professional for guidance.)
Check your BG (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 you answered yes, then repeat this test with the same meal on another day to verify your results.
* If you answered no, discuss this with your healthcare professional for guidance.
Example #1: Dual Wave bolus
Set a Dual Wave bolus for a barbecue style dinner
Carol is going to a barbecue at a friend's house. Her meal consists of:
mixed green salad fruit
potato salad
salad
baked
a dinner roll and margarine
beans pork ribs with barbecue sauce
She calculates her total carbohydrates and determines her total meal bolus amount. She knows that she will need some insulin
immediately for the fruit, barbecue sauce and dinner roll and some insulin spread out over time for the high fat and high fiber content of
the rest of the meal. Carol will program her pump to deliver a Dual Wave bolus with ½ of the total bolus to be given immediately and
the other half over a 2- hour* duration.
(* This particular duration of time and bolus proportions is an example. As always, you should consult with your healthcare professional
for your individual needs. )
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Example #2: Dual Wave bolus
Set a Dual Wave bolus for correcting elevated BG before a meal
Marsha uses the Square Wave bolus for the majority of her meals. She tests her pre-meal BG and finds that it is above her target level.
Marsha would like to correct her elevated blood glucose before she eats. The Dual Wave bolus can be used to deliver some insulin
now to help correct her blood glucose elevation, and then deliver her Square Wave bolus to cover her meal.
Your turn:
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 ½ 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 you answered yes, then repeat this test with the same meal on another day to verify your results.
* If you answered no, discuss this with your healthcare professional for guidance.
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Using Bolus Wizard for a Square Wave or Dual Wave bolus
If you are using Bolus Wizard to calculate your Square Wave or Dual Wave bolus amounts, you will be prompted to enter your BG
reading and/or the (carb or exchange) units you will eat. Bolus Wizard will use this input to calculate your suggested correction and/or
food bolus amount. If you do not want to use the Bolus Wizard estimate, you can change it, if desired.
1. Bolus Wizard must be turned on and the settings must be programmed. Also, make sure the dual/square option is turned on.
2. After you enter your BG and/or food entry, review the information in the ESTIMATE DETAILS screen. Press ACT to continue to step 3.
If you need to make any changes, press ESC to return to the ENTER BG screen and make changes as necessary.
Apex Medical
ESTIMATE DETAILS
Est total:
4.0U
Food intake:
(Meter)BG:
45gr
180
Food:
3.0U
Correction:
2.0U
Active Ins:
1.0U
ACT to proceed,
ESC to back up
3. In the next screen, select Square Wave Bolus or Dual Wave Bolus as desired and press ACT.
NOTE - If you are using Bolus Wizard and it calculates that your bolus includes a portion to correct your high BG, the Square
Wave bolus 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 BG.
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4. For a Square Wave bolus do these steps:
The SET SQUARE BOLUS screen will appear. Change the amount if desired. Press ACT to accept. Go to step 5.
Apex Medical
SET SQUARE BOLUS
U
ACT
Apex Medical
SQUARE DURATION
Sq:4.0U
For a Dual Wave bolus do these steps:
NOTE - The number of units you program for the SET DUAL BOLUS TOTAL is a total of both the Normal and Square Wave bolus
units.
The SET DUAL BOLUS TOTAL screen will appear. Change the amount if desired. Press ACT to accept.
5. The SQUARE DURATION screen will appear. Enter the amount of time you want the Square Wave bolus to last and press ACT.
6. Press ACT to accept and deliver the bolus. The BOLUS DELIVERY screen will appear. The pump will beep or vibrate at the start and
end of the bolus. As the bolus is delivered, the screen will show the bolus type and amount until the total units have been delivered. An
open circle will appear indicating that your pump is in Special mode. If you want to see the progress of the delivery, press ACT to see the
STATUS screen.
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Basal schemes
The Basal schemes feature is optional for pump users. Based on your individual daily, weekly, or monthly needs, you can choose
different basal schemes. Keep a paper copy of your programmed schemes with you at all times in case you need to reprogram your
pump.
Basal schemes are useful to establish different sets of basal rates to match different needs such as:
◆ Changes in time of sleep (for example, work shift)
◆ Extended periods of higher or lower activity
◆ Different schedules during the week versus weekend
◆ Softball games every Saturday morning, etc.
◆ Menses
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 another schemes.
Select a schemes
Your pump will keep your pattern settings even when you select another scheme.
NOTE - Be aware. When you make changes to a scheme, the pump will use that scheme as the current basal. Make sure the
basal you want is selected in the Select Basal Schemes screen.
1. Go to the Select Basal Schemes screen, press ACT.
Main > Basal > Select Basal Schemes
2. Select the desired scheme, press ACT.
Select No or Yes and press ACT.
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3. The screen will return to the Set/Edit Basal. Your basal scheme is now active. Exit the menus.
Example #1:
Basal schemes
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 Schemes feature to support his weekend change in activity. During the week, he can set his pump to deliver in
Scheme 1, and on Saturday morning, he can switch over to other Scheme 2, which he can set with lower basal rates for the weekend.
On Monday morning, he can return his pump to the Scheme 1 for his weekday insulin needs.
Example #2:
Basal schemes
Cynthia has had diabetes for about 12 years and has been on her TruCare pump for several weeks. Every Monday, Wednesday and
Friday, Cynthia goes on a 2-mile walk in the morning. To prevent hypoglycemia on these days, she uses the schemes feature. For
those days, she simply switches over to Scheme 2, which she has programmed with a lower set of basal rates. Before she learned to
use the schemes 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
Scheme 3 on her Paradigm pump with higher basal rates for this time. For her usual schedule, she uses the Scheme 1.
Your turn:
Can you think of situations where you might require different basal rate settings on different days?
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Temp basal rates
The temp basal rate feature is useful to manage BG levels during unusual short-term activities or conditions. These conditions could be
an illness or unplanned physical activity that is not part of your daily routine.
A temporary basal rate allows an immediate short-term change to your basal insulin for a specified period of time (30 minutes –
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.
NOTE - Temp Basal is useful for a temporary condition or period of increased or decreased activity (i. e. a cold or physical
activity) that is not usually part of your lifestyle. 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 the similar situations.
Temp basal types
Based on your preference, you can select one of two types of temp basals:
‹ Insulin rate
‹ Percent of basal
Insulin Rate
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.
temp basal settings
temp basal type:
Insulin rate (U/H)
duration:
4 hours (13: 05 - 17: 05)
rate:
3. 5U/H
If you make changes to your normal basal rate, your U/H temp basal is not
affected and will continue to deliver as programmed.
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Percent of basal
The temp basal type is dependent on your current basal rates. Percent temp basal is a percentage increase or decrease of your current
basal (0 - 200 percent limited to your maximum basal rate setting) .
The maximum percent limit is based on the largest basal rate segment of your current basal. For example: It’s 18: 00 (your current
basal rate is 1.3 U/H) . You want to set a temp basal of 150%. The maximum percent temp basal you can set is 105%. Anything larger
would make #2 segment exceed your max basal setting of 2.0 U/H.
Your current basal rates:
Your max basal rate setting: 2 0 U/H
segment #1: 00:00 1.5 U/H
segment #2: 11:30 1.9 U/H (largest)
segment #3: 16:00 1.3 U/H
If your current basal changes (i.e. 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. 1 increments. Because of this, your temp basal amount will be rounded down to
the next 0. 1 increment.
temp basal settings
temp basal type:
duration:
rate:
Percent of basal
4 hours (13: 05 - 17: 05)
120 percent (%)
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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. Go to the BASAL MENU.
Main > Basal > Temp Basal Type
Select Temp Basal Type and press ACT.
2. The SET TEMP BASAL AS screen will appear.
Select Insulin Rate or Percent of Basal and press ACT.
3. The screen will return to the BASAL MENU. The temp basal type is now set. Exit the menus.
NOTE - Be aware. If your temp basal type is set to “Percent of Basal”, changes to your basal rate are not allowed until after
temp basal is completed or canceled.
Deliver a temp basal
NOTE - A temp basal cannot exceed your programmed max basal rate.
1. Go to the BASAL MENU.
Main > Basal > Set/Edit Temp Basal
Select Set/Edit Temp Basal and press ACT.
2. The SET DURATION screen will appear. The duration* will flash. Enter the desired minutes or hours (30 minutes - 24-hours), then
press ACT.
NOTE - * Duration is the amount of time it will take for the pump to deliver the temporary basal.
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3. In the SET TEMP BASAL screen, the temporary basal rate will flash. Enter your temp basal rate, then press ACT.
4. The BASAL MENU will appear. Your temp basal is now set and delivering.
Exit the menus.
During a temporary (temp) basal, the pump is in Special mode. Additionally, your pump will beep/vibrate three times every hour during
delivery.
Canceling a temp basal
Use the cancel temp basal function in the Set/Edit Temp Basal 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. Go to the Set/Edit Temp Basal.
Main > Basal > Set/Edit Temp Basal
2. Select Cancel Temp Basal and press ACT to accept. The screen will return to the BASAL MENU. Your temp basal is canceled and
the programmed basal is now active again. Exit the menus.
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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 sometime during, and very often after, he played games with his
friends. Now that he is using his TruCare 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 ½ 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 2 hours) , he found a temporary basal rate that
worked well for him.
Example #2:
Temp Basal for an increased temporary basal rate
Gail has had a cold with a cough for a couple of days. Because she is not feeling well, she tests her blood glucose more frequently.
She finds that her blood glucose levels are running above target range before meals and she has needed several correction boluses to
keep her blood glucose levels within her normal limits. Gail decides to use the Temporary Basal Rate to increase her basal rate during
the day today. As advised by her healthcare professional, she will continue to check her blood glucose more frequently until she is
feeling well.
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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?
85
Chapter 7
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:
Laboratory tests:
◆ Check BG 4-6 times a day and always before bed
◆ Test before driving and have a fast-acting carbohydrate with
you when you drive
◆ If your BG is above 250 mg/dL (13. 9 mmol/L) twice in a row,
take an injection and change the infusion set
◆
◆
◆
Every visit:
◆
◆
◆
Every month:
◆
◆
◆
Test for HbA1c four or more times a year
Test for cholesterol, HDL, LDL, triglyceride yearly
Test for microalbuminuria yearly
Review DKA prevention guidelines
Check 3: 00AM BG at least once during the month
Check 2-hour post-meal BG for all meals on a given day
Blood pressure check
Foot exam
Review goals for BG, meal plan and exercise
Annually:
◆ 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
Every 3 months:
◆ Visit your healthcare professional, even if you feel well and
your BG values are within target range
◆ Review your BG log and insulin pump settings with your
healthcare professional
◆ Make sure you have an HbA1c test done
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Chapter 8
Utilities
Alarm review
You can review alarms in the ALARM HISTORY screen. This screen shows up to 32 past alarms and/or errors.
1. Go to the ALARM HISTORY screen.
Main > Utilities > Alarm > Alarm History
2. Scroll through your past alarms.
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 vibrate alert type is disabled if you use the block feature. 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.
NOTE - Vibrate uses more battery power than the beep alert type and may shorten battery life.
1. Go to the ALERT TYPE screen.
Main > Utilities > Alarm > Alert Type
2. Select your alert type and press ACT. That alert type is now active. Exit the menus.
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Low reservoir warning
Allows you to program the pump to sound an alert before your reservoir is empty.
The factory setting for this feature is (20) insulin units.
1. Go to the RESV WARNING TYPE screen.
Main > Utilities > Alarm > Low Resv Warning
WARNING: When the pump detects a low reservoir condition during a bolus or prime delivery, the alert will go off after the
delivery is finished. Make sure to check the volume of your reservoir to ensure enough insulin is available.
2. Enter the number of units you want remaining when the first warning will go off. Press ACT.
The pump will alarm first when the specified units remain, then again when half that remaining amount is used.
Review daily insulin totals
The DAILY TOTALS screen provides a day-by day history of the total amount of insulin that delivered for the past 40 days. This screen
includes all bolus and basal amounts delivered midnight-to midnight for each of the past 40 days. The first line in the DAILY TOTALS
screen shows the amount of insulin you delivered so far that day.
NOTE - The insulin used to prime your pump are not included in the DAILY TOTALS screen. This amount is counted separately
and shown in the PRIME HISTORY screen.
‹
Why should I review my daily totals?
Comparing your daily insulin deliveries to your blood glucose records helps you and your healthcare professional identify your optimal
daily insulin rate (s) .
‹
What is included in the daily totals?
Daily totals include all basal and bolus insulin deliveries, but they do not include insulin used for priming your pump. Each total reflects all
basal and bolus insulin delivered for that day.
88
‹
Where is the daily totals screen?
Main > Utilities > Daily Totals
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. Direct pump programming is limited to suspend, block, and
selftest. You can, however, still view status-type screens (STATUS, BOLUS and PRIME HISTORY, BASAL REVIEW and DAILY
TOTALS) .
Turn block on
NOTE - The vibrate alert-type is disabled when block is on.
1. Go to the BLOCK OPTION screen.
Main > Utilities > Block
2. Select On and press ACT.
The Block option is now on and the pump is in Special mode. Exit
the menus.
Example #1: Block
Nicholas is a very active toddler who wears a TruCare 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.
89
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
TruCare pump with the Block feature turned on.
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 the Apex Medical 24-hour Product Help Line if any of the tests do not occur as described here.
1. Go to the UTILITIES MENU. Select Selftest and press ACT.
Main > Utilities > Selftest
2. As part of the selftests, the pump will do these tests:
NOTE - Periodically, you will hear beeps as different mechanisms in the pump are being tested.
a. Screen Test:
The screen will appear all black as shown here.
b. Selftest: The pump will count down from 10.
c. Tone Test: You should hear beeps.
d. Vibrate Test: You will feel vibrations.
3. After the selftest is finished, TEST COMPLETE will appear on the screen. The screen will return to the UTILITIES MENU, then to the
HOME screen.
4. Reset the time and date as described in the section, “Setting the time and date” in chapter 3.
90
Clear pump
The clear pump function resets the time and date and clears all pump settings except for language. The pump settings are restored to the
factory defaults. When you clear your pump, you must 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 while it is connected to your body.
CAUTION: Do not clear your pump unless directed by your healthcare professional or a Apex Medical representative. If you
clear your pump, it will be necessary to reprogram all your personal pump settings as directed by your healthcare professional.
Do these steps to clear your pump:
1. Go to the CLEAR PUMP screen. Select Start and press ACT.
Main > Utilities > Clear Pump
2. The CONFIRM screen will ask you to verify that you want to clear the pump. Select Yes then press ACT.
3. The pump setting is now clear. Exit the menus.
Language setting
The language shown on the pump screens can be changed. Some languages will not be available on all pumps.
To change the language for your pump, do these steps:
1. Go to the LANGUAGE MENU. Select your language and press ACT.
Main > Utilities > Language
2. The language setting is now changed. Exit the menus.
91
Chapter 9 Troubleshooting and alarms
NOTE - It is recommended that you read your warranty statement included with your pump for information on what is covered
during your warranty period.
Troubleshooting
My pump has a no delivery alarm. . .
When a “Delivery Stopped” 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. Check your blood glucose and take an injection if needed.
2. Make sure that there is insulin in your reservoir and the tubing is not kinked. If these are all right, go to step 5.
3. If necessary unlink tubing. Clear the alarm by pressing ESC and ACT.
4. 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 chapter 6, “Starting on insulin. ”
5. Continue troubleshooting by disconnecting at the quick-disconnect and set a 10 unit Fixed Prime.
6. Does insulin come out of the needle at the quick-disconnect?
a. If yes, change your entire infusion set per the instructions in chapter 6, “Starting on insulin. ”
If NO insulin comes out of the needle at the quick-disconnect or you receive another Delivery Stopped alarm call the 24-hour Product
Help Line.
b. Your pump remembers the last fixed prime you deliver, so make sure to set your fixed prime amount back to your usual setting. To do
this, deliver another fixed prime in your normal amount (the amount specified in your infusion set instructions) .
7. Monitor your blood glucose closely.
8. If you followed these steps and you are still receiving a Delivery Stopped alarm, call the 24-hour Product Help Line.
92
What happens if I leave the battery out too long?
If you leave the 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. Set your pump clock to the correct time, date, and year.
2. Check to make sure that all your settings, such as basal rate, are set as desired.
3. Check the ALARM HISTORY screen and the STATUS screen for any alarms and/or alerts that may still need attention.
Why doesn’t my pump battery last very long?
Battery life in your pump is variable and based on the conditions below. As a result, your battery life will vary. A short battery life does not
necessarily mean something is wrong with your pump.
◆
The brand of battery you use.
◆
The way the battery was stored and/or handled before use (avoid high or low temperatures).
◆
How you use your pump. For example: how often the buttons are pushed, the number of alerts/alarms and set changes.
◆
How much insulin you are delivering.
◆
Use of some features. The backlight and/or vibrate options decrease battery life.
My screen appears distorted...
The screen may appear distorted or have a “rainbow” 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 (i. e. , 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.
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. If you dropped your pump, visually inspect it to make sure that it is not damaged in any way.
2. Review your bolus history and reprogram the remaining bolus, if needed.
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I dropped my pump
Take care to protect your pump from being dropped.
1. Check that all connections are still tightly in place.
2. Check the LCD, keypad and pump case for cracks or damage.
3. Check infusion set, including the tubing connector and tubing for cracks or damage.
4. Review the status screen, basal rates and other pump settings.
5. Perform the Self-test procedure located in the UTILITIES MENU.
6. Call the Apex Medical 24-hour Product Help Line for assistance.
I submerged my pump in water
Your pump is water tight but should not be deliberately submerged in water during bathing, swimming, or other water activities.
1. Pat the outside of the case until dry.
2. Open the reservoir compartment and check the compartment and reservoir for water. If wet, dry it completely within ten (10) minutes of
exposure to water. Exposure to liquids, including water or insulin can corrode the mechanism.
3. Dry the reservoir completely - do NOT place a wet reservoir in the pump.
4. Do not use hot air to dry your pump. This may damage your pump's internal electronics.
5. Check the battery compartment and the battery - if wet, let them dry completely before using the pump.
6. Perform a self-test.
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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 will illuminate the pump screen and the alarm/alert message will
appear on the screen.
Why are alarms important?
Your pump monitors activities and will notify 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.
Your insulin pump does not beep or vibrate. Check that the beep volume and alarm signals are turned on. Check and change the battery.
If your insulin pump still does not beep or vibrate, contact pump support.
What to do
When an alarm is triggered, the pump goes into Attention mode and an alarm message will show on the screen. The pump will then
default to the HOME screen. Do these steps when you get an alarm:
1. View the alarm:
From the HOME screen, press ACT to see the alarm message.
2. Read all of the alarm text. There will be instructions on how to fix the alarm condition.
3. Clear the alarm:
Press ESC and ACT after you read the alarm instructions.
4. The MAIN MENU screen will appear.
5. Follow the instructions that appeared with the alarm to fix the alarm condition.
6. Check your settings (i.e., time/date, basal, etc.) to make sure they are correct.
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Alarm conditions
No
Screen display
Meaning
What to do
1
Occurs if a button has been continually
pressed for more than 1 minutes.
Press ESC 、 ACT to release from the
situation.
2
There is no insulin in the reservoir.
Press ESC、ACT to clear. And change the
reservoir and infusion set immediately.
3
There is little insulin in the reservoir.
Press ESC、ACT to clear. And prepare
reservoir, infusion set and insulin.
4
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.
Replace battery now. (Always make sure
that you install a NEW battery into the
pump. )
5
The pump tests the voltage of each
battery installed. If the battery voltage is
less than full strength, this alarm may
occur.
Press ESC、ACT to clear and prepare a
NEW battery.
6
The battery is dead.
Replace battery immediately. Check to
make sure that the time is correct on the
screen. Reset the time if necessary.
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7
Insulin delivery has stopped.
Press ESC、ACT to clear and disconnect
set.
8
Read/write clock error.
Press ESC 、 ACT to clear and setting
Time/Date again.
9
Failed Communication
Press ESC、ACT to clear and suspend the
pump.
10
Rewind/prime has stopped.
Press ESC、ACT to clear. Check infusion
set and try again.
11
Insulin delivery has stopped. This alarm
will occur if your pump detects a
blockage.
Press ESC、ACT to clear. Disconnect and
re-prime your infusion set. Check your
blood glucose. If the occlusion remains,
prime the pump without the reservoir
inserted.
If an error “DELIVERY STOPPED” occurs, immediately check your blood glucose level, and check again in about 2 hours, because
insulin delivery has been interrupted. If your blood glucose level is high, take appropriate actions according to your healthcare
instructions.
Insulin (a maximum of 2. 0units of U100 insulin) was not delivered. This may be due to:
◆ a blocked infusion set,
◆ a reused reservoir, or
Note- The display of this error depends on several factors including your current hourly basal rate and boluses. For example, a blocked
infusion set with a basal rate of 2. 0 U/H (U100 insulin and no additional boluses) would trigger an alarm DELIVERY STOPPED in
approximately two hours or less, depending on the type and severity of the blockage.
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If the occlusion (blockage) was inside your infusion set, follow the steps below.
1. Press ESC and ACT to clear the alarm.
2. Disconnect or remove the infusion set from your infusion site.
3. Change the infusion set and prime it.
4. Reconnect the infusion set (tubing) at your infusion site.
In rare cases, the reservoir itself can be the cause of the occlusion. If an alarm DELIVERY STOPPED occurs again, you must change the
reservoir. Follow the steps below:
1. Press ESC and ACT to clear the alarm.
2. Disconnect or remove the infusion set from your infusion site.
3. Change the reservoir and prime the infusion set.
4. Reconnect the infusion set (tubing) at your infusion site
If the alarm DELIVERY STOPPED occurs again, prime your pump without a reservoir. Follow the steps below:
1. Press ESC and ACT to clear the alarm.
2. Disconnect or remove the infusion set from your infusion site.
3. Remove the reservoir and infusion set from your pump.
4. Carry out the PRIME THE infusion SET function without the reservoir, and infusion set inserted.
5. Insert a new reservoir with connected adapter and infusion set.
6. Prime the infusion set.
7. Reconnect the infusion set (tubing) at your infusion site.
If the alarm DELIVERY STOPPED continues to occur, contact your healthcare for an alternate therapy plan. Contact Pump Support at
86-510-80100606 for more assistance.
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Chapter 10
Pump maintenance
It is recommended that you read your warranty statement included with your pump for information about what is covered during your
warranty period.
Battery
The TruCare pump uses a AAA alkaline battery. As a safety measure, Apex Medical has designed the pump to only accept a NEW
battery. The pump is very particular, if you insert a used battery, an alarm will be triggered. Refer to the section, “Install battery” in chapter
2 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:
◆ Backlight
◆ Vibrate alert type setting
WARNING: After inserting a new battery, always check that the time and date of your insulin pump are set correctly. Incorrect
programming of the time and date may cause incorrect insulin delivery. If you, your doctor, or healthcare team store and analyze your
therapy data electronically and the time and date of the devices used are not set identically, the gathered data might not be meaningful.
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).
Caution: When your insulin pump will not be in use for a long period of time, it should be properly stored, to prevent a malfunction.
To store your pump, place in main menu, then:
◆ Remove the battery
◆ Remove the reservoir
◆ Insert the battery cover
◆ Store your pump in its shipping case
Storage Conditions
◆ Temperature: 41°F to 113°F (+5°C to +45°C)
◆ Air humidity: 5 to 85% relative air humidity
◆ Barometric pressure: 860 to 1060 mbar
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Cleaning your pump
1. Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump.
2. After wiping down the pump, rinse with clean water and dry with a cloth.
3. Never use organic solvents, such as lighter fluid, nail polish remover, or paint thinner to clean your pump.
4. Keep the reservoir compartment and battery compartment dry and away from moisture.
5. Do not use any lubricants with your pump.
6. Use a 70 percent alcohol wipe to disinfect your pump.
Repair
If you have problems with your pump, contact Pump Support at 86-510-80100606. Pump Support can help you and answer many
questions over the telephone.
Pump Support may direct you to return your pump to Apex Medical for repair.
If you must ship your pump, carefully pack the pump and the used reservoir, battery, battery cover, and infusion set to avoid damage to
them during transportation. Place your pump back in the shipping case and put the case in a package that will not rip or tear. It is best to
send your pump using a shipping method and carrier that tracks the shipment.
When you return your pump, include the following:
◆ a description of the reason for returning your pump
◆ your name and address
◆ your daytime phone
◆ the serial number of your pump, and
◆ any RMA (Return Material Authorization) number received from Pump Support.
By returning your pump to Apex Medical, you allow Apex Medical to undertake any testing on your inslin pump that is needed for a proper
inspection, and understand that your pump may not be returned to you.
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Chapter 11
User safety
Indications
The pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons
requiring insulin.
Contraindications
Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four (4) 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.
Warnings
Reservoir and infusion set
EASY SET reservoir and EASY SET infusion set are specifically designed for use with the pump. Do not modify your reservoir or 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.
Wearing your pump
Caution: When wearing your insulin pump make sure to prevent any contact with objects that may damage or accidentally press the keys
of your insulin pump (e. g. , keychains, keys, pocket knives, and coins) .
Attach your pump safely to your body or clothes to prevent damage. Special carrying systems let you carry your pump on or under your
clothes. All specified accessories have been tested and approved for use with your TruCare insulin pump. The proper functioning of your
pump can only be guaranteed if you use it with TruCare insulin pump accessories.
Wear your pump under your clothes or directly on your body in cold or rainy weather. If you have concerns about the weather affecting
your pump, check the operating conditions of your pump and contact pump support at 86-510-80100606.
Caution: Do not place your insulin pump in direct sunlight. Overheating of the insulin and your insulin pump must be avoided. Protect
your insulin pump from direct exposure to cold wind and temperatures over 104°F (40°C) and below 41°F (5°C) . These conditions may
damage the insulin and the electronics of your insulin pump and may cause a malfunction of the battery.
101
When not to wear your pump
Electromagnetic Fields and Hazardous Areas
Do not use your pump around electromagnetic fields such as radar or antenna installations, high-voltage sources, X-Ray sources, MRI,
CAT scan, and all other sources of electrical current as they may cause your pump not to work. Insulin delivery may stop and an error
may occur.
Always stop and remove your pump before you enter these areas.
Your pump has been tested and complies with the regulations regarding unintentional electromagnetic interference. Security systems in
airports as well as anti-theft monitoring devices, such as those in department stores, should not affect the functioning of your pump.
Because there are so many devices, such as cellular phones, that give out electromagnetic radiation, the influence of some such devices
on your pump cannot be ruled out. It is a good idea to keep your pump at least 4 inches (10 cm) away from such devices while the other
devices are turned on.
Do not use your pump in hyperbaric chambers and in hazardous areas of any kind, such as areas where explosive or flammable gases
or vapors could exist.
This could affect insulin delivery and/or lead to harm.
Your pump is designed to work in normal barometric conditions (from 860 to 1, 060 mbar) .
Do not exceed 10, 000 feet (3, 000 meters) above sea level. Your pump has not been tested for use above this level.
Always stop and remove your pump before you enter these areas. If you have questions, contact Pump Support at 086-510-80100606.
Sports and Exercise
Exercise is an important part of diabetes management. Apex Medical designed the TruCare insulin pump to let you safely perform many
sporting activities while you wear your pump. It is important that you protect your pump before you start exercise or sports activities. Do
not wear your pump during sports that involve body contact such as boxing, football, or hockey since rough contact could damage your
pump.
Consult our sterile products brochures and accessories catalog for more information regarding carrying systems or contact Pump
Support at 086-510-80100606 for more information.
Traveling
Ask your doctor or healthcare team about any special actions you need to take before you travel. Take extra blood-glucose testing and
pump supplies when you travel and find out where to get supplies while you are traveling.
When you travel across time zones, make sure that the time and date on your pump are set correctly to the local time.
The TruCare insulin pump has not been tested at altitudes in excess of 10, 000 feet (3, 000 meters) above sea level. If your travels take
you to an area in excess of 10, 000 feet (3, 000 meters) above sea level, stop and remove your pump. This does not apply to use in
airplanes with pressurized cabins.
If you have questions, contact Pump Support at 086-510-80100606.
Your pump and water
Caution: Avoid deliberate contact with water. Check daily that your insulin pump is not chipped, cracked, or damaged in any way and
that the battery cover and the adapter are correctly closed. In the presence of chips and cracks, water, dust, insulin, or other foreign
102
substances may enter your insulin pump and lead to malfunction. Prior to contact with water, disconnect and take off your insulin pump.
Disconnect and remove your pump before entering a bathtub, Jacuzzi or whirlpool, shower, or swimming pool. Avoid exposing your pump
to high humidity, such as in a sauna, as this could damage your pump. To make it easy to remove your pump, use disconnectable
TruCare infusion sets.
Consult your doctor or healthcare team to find out how long your insulin pump therapy can safely be interrupted.
Accidental Contact with Water
Your insulin pump is protected against accidental short-term water contact. Examples of accidental short-term water contact include:
• rain, snow;
• water that splashes while you are biking, jogging, or hiking;
• accidental brief immersion into the sink or bathtub.
What to do after any water contact
Your pump is water tight but should not be deliberately submerged in water during bathing, swimming, or other water activities.
1. Pat the outside of the case until dry.
2. Open the reservoir compartment and check the compartment and reservoir for water. If wet, dry it completely within ten (10) minutes of
exposure to water. Exposure to liquids, including water or insulin can corrode the mechanism.
3. Dry the reservoir completely - do NOT place a wet reservoir in the pump.
4. Do not use hot air to dry your pump. This may damage your pump's internal electronics.
5. Check the battery compartment and the battery - if wet, let them dry completely before using the pump.
6. Perform a selftest.
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 BG is out of range, check the pump and the infusion
set to ensure that the necessary amount of insulin is being delivered.
Precautions - infusion sets and sites
Avoid using an infusion site that will be irritated by clothing and accessories, or by rigorous stretching and exercise.
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Chapter 12
Pump specifications
This section provides detail information on specifications related to your pump. The safety features of your pump are individually listed
and described.
Air humidity
During operation:20 to 90% relative humidity
Stored in its shipping case:5 to 85% relative humidity
Barometric pressure
During operation or stored in its shipping case:860 to 1,060 mbar [do not exceed 10,000 feet].
Temperature ranges
During operation:41°F to 104°F(5°C to 40° C)
Stored in its shipping case:41°F to 108°F(5°C to 42° C)
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.
Backlight
LCD(Liquid Crystal Display)type
Time-out:15 seconds(in the HOME screen);
15 seconds(after the last button press).
Default screen
The HOME screen.If no buttons are pressed for 15 seconds, the pump returns to this screen.
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Status screen
Time: always appears
Block: (if active) ON
Last bolus information: type and units delivered, delivery time and date
Standard basal delivery data: (always appears) current basal rate
Reservoir started: (always appears) date, time, units left
Battery Status: (always appears) Normal, Low, Off, Weak
Current date: DD ## MM YYYY
Serial number: always appears
Pump model number: always appears
Software version: always appears
Basal
Delivery:0.1 – 35 units/hour(Maximum units:35/hour)
Factory maximum setting:2.0 units/hour
Increments:0.1 units
3 schems maximum,each with 24 rates maximum
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.
Delivery accuracy
Trumpet curve plotted from data after the end of the stabilization period
The trumpet curve shows the accuracy of the delivery rate in relation to the observation period.
The measurements were made at a medium basal rate of 1.0 U/h according to IEC 60601-2-24:1998 with a infusion set 16/110 at room
temperature.
105
The average deviation of the delivered amount(overall mean percentage flow error)for U100 insulin is ≤ ± 5%.
Start-up graph over the stabilization period
The start-up graph shows changes in the flow rate over the stabilization time.
The measurements were made at a medium basal rate of 1.0 U/h according to IEC 60601-2-24:1998 with a infusion set 16/110 at room
temperature.
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Influence of height on delivery accuracy
The average deviation of the delivered amount (overall mean percentage flow error) for U100 insulin is ≤ ± 10% when your TruCare
insulin pump is located 3.3 feet (1 m)above/below the level of infusion site.
Trumpet curve plotted from data after the end of the stabilization period
The trumpet curve shows the accuracy of the delivery rate in relation to the observation period.
The measurements were made at a medium basal rate of 0.1 U/h according to IEC 60601-2-24:1998 with a infusion set 16/110 at room
temperature.
The average deviation of the delivered amount(overall mean percentage flow error)for U100 insulin is ≤ ± 20%.
Start-up graph over the stabilization period
The start-up graph shows changes in the flow rate over the stabilization time.
The measurements were made at a medium basal rate of 0.1 U/h according to IEC 60601-2-24:1998 with a infusion set 16/110 at room
temperature.
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Bolus
Delivery:0.1 – 25 units/time(Maximum units:25/time)
Factory maximum setting:10.0 units/time
Increments:0.1 units
Insulin delivered/
stroke
Fluid delivered/
stroke
Time between
delivery strokes
Delivery rate
(per minute)
0.1U
1 μL
4 seconds
1.5U
Maximum records shown:32
For U100 insulin the delivery accuracy of a maximum bolus is ≤ ± 5% and the delivery accuracy of a minimum bolus is ≤ ± 20%.
The measurements were made according to IEC 60601-2-24:1998 with a infusion set 16/110 at room temperature.
Delivery mode
Delivery rate/volume
Accuracy
Range
Basal
0.1 U/h
± 20%
0.08 - 0.14 U/h
Bolus
0.1 U
± 20%
0.09 - 0.15 U
Dual Wave bolus
Delivers a Normal bolus followed by a Square Wave bolus(limited by maximum bolus).
Square Wave bolus
Delivers bolus insulin over a duration of 30 minutes up to 8 hours(limited by the max bolus setting).
Prime
Fixed prime:0.1 – 25.0 units(limited by maximum bolus)
Manual prime limit:warning at 25 units,then at each 25 units thereafter.
Prime insulin is not counted in daily totals but is recorded separately in the prime history.
Maximum records shown:64 (manual and fixed)
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Alarm history
Maximum records shown:32
Daily totals
Maximum records shown:40 days of data
Accuracy:+0/–0.1 units
Drive motor
The pump motor has a unique,patented design with an integrated safety check system. The system delivers in precise increments.
(Insulin)sensitivity
Maximum settings:8
Factory default:50 mg/dL(2.8 mmol/L)
Range:10 – 250 mg/dL
(0.5 – 13.9 mmol/L)
Insulin type
U100 fast-acting [operating temp.of 72°F ± 6°F(22°C ± 3°C)]
Low resv(reservoir)warning
Values are based on displayed amount, not actual amount.
Infusion pressure
Maximum infusion pressure and occlusion pressure: 13.7 PSI.
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Occlusion detection
When occlusion is detected,the “delivery stopped” will occur.
Rate
Maximum time
before alarm
bolus delivery(1.5 u/minute)
144 seconds
basal delivery(2.0 u/h)
108 minutes
basal delivery(0.1 u/h)
36 hours
The alarm time and pressure are not selective or changeable.
Maximum volume before alarm
Maximum volume before alarm:≤ 3.6 U
Maximum quantity delivered at a single fault condition
Maximum quantity delivered at a single fault condition:≤ 1.0 U
Power supply
The pump is powered by a standard 1.5 V AAA alkaline battery.
Battery life
If used in a standard pattern [50 U/day using U100 insulin] the battery life is approx two weeks.
Data storage time
The time and date is safely stored in the memory for about 5 minutes after the battery has been removed.
Your insulin pump’s settings (the hourly basal rates,remaining reservoir content,bolus,and active user menu)and the event
memory(basal history,bolus history,history of daily insulin totals,Temporary Basal Rate history,alarm history,prime history and suspend
history)are saved,regardless of battery voltage and time the insulin pump has been without a battery.
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BG target
Maximum targets:8
range:80 – 160 mg/dL
(4.4 – 8.9 mmol/L)
Carb ratios
Maximum ratio settings:8
range:3 – 75 grams/u
0.2 – 5.0 u/exch
Carb units
(The food entry when using Bolus Wizard)
grams:0 – 300 (increments:1 gram)
exchanges:0.0 – 20 (increments:0.5 exch)
Pump size
88mm×58mm×20mm
Pump weight
Approximately 105 grams(with battery installed)
Reservoir
The user-filled reservoir is made from impact-resistant,insulin-compatible polypropylene.
Pump volume:up to 300 units of U100 insulin
Water tight
Conforms to IEC60601-1 sub-clause 44.6 and IEC60529 IPX7 standard.
Protection against the effects of temporary immersion in water.Ingress of water in quantities causing harmful effects is not possible when
the device is temporarily immersed in water under standardized conditions [maximum of 30 minutes a day and 3 feet(1.0 meters)depth].
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Service life
Four years
Pump casing
Shock,scratch,pharmaceutical resistant plastic. All edges are rounded.
Technical standards on Electromagnetic Emissions
The standard concerning electromagnetic compatibility of medical equipment(IEC 60601-1-2:2007)requires the concrete specification of
the corresponding levels which refer to specified electromagnetic interferences.The following is Guidance and manufacturer’s declaration
on electromagnetic emissions.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The TruCare insulin pump uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class B
The TruCare insulin pump is suitable for use in establishments, including domestic
establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Not applicable
Note 1:At 80 and 800 MHz, the higher frequency range applies.
Note 2:These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Note 3:Field strengths from fixed transmitters, such as base stations for radio(cellular/cordless)telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the TruCare insulin pump is used exceeds the applicable RF compliance level above, the TruCare insulin
pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the TruCare insulin pump.
Note 4:Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
112
V,in V:10.00
Rated maximum output
power of transmitter W
E,in V/m:10.00
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
outside ISM bands
80 MHz to 800 MHz
800 MHz to 2,5 GHz
0.01
0.04
0.04
0.07
0.1
0.11
0.11
0.22
1
0.35
0.35
0.70
10
1.11
1.11
2.21
100
3.50
3.50
7.00
Technical standards on Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The TruCare insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the
TruCare insulin pump should assure that it is used in such an environment.
IMMUNITY test
IEC 60601 TEST
LEVEL
Compliance
level
Electromagnetic environment - guidance
Electrostatic
discharge(ESD)
IEC 61000-4-2
± 6kV contact
±8 kV air
± 8kV contact
±15 kV air
(IEC 60601-2-24)
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30 %.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
400A/m
(IEC 60601-2-24)
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
Conducted RF
IEC 61000-4-8
3 Vrms
150 kHz to
80 MHz
Not applicable
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IMMUNITY test
Radiated RF
IEC 61000-4-3
IEC 60601 TEST
LEVEL
Compliance
level
3 V/m
80 MHz to
2,5 GHz
10V/m
80 MHz
2,5 GHz
(IEC 60601-2-24)
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the TruCare insulin pump,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
d = 0.4 P 80 MHz
to 800 MHz
d = 0.7 P 800 MHz
to 2,5 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:
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Sterile Products and Accessories
Sterile Products
Name
Model
Comments
Reservoir
3mL
EASY SET
Plastic cartridges are single-use items. Do not reuse cartridges. Refer to the instructions of the
insulin you are using for information of proper use and acceptable temperature range for
storage and handling.
Infusion set
EASY SET
Ultra-fine stainless needle inserts easily with one hand and is a great option for new pumpers
or those with vision or dexterity issues.
Accessories
Name
Comments
Battery
One 1.5 AAA alkaline
battery
If used in a standard pattern [50 U/day using U100 insulin; operating temp,of 72°F ± 6°(22°C ± 3°C)] the
battery life is approx two weeks.
You can buy it in the supermarket.
Carrying systems
Apex medical offers a wide range of carrying system solutions to best fit your lifestyle.
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Bolus Wizard specifications
Notes:
* Active insulin is based on timing of previous bolus insulin and insulin type. Four to six hours after a bolus,the majority of insulin has
been absorbed,but a very small amount is active for a few more hours. The Bolus Wizard automatically calculates this and subtracts the
appropriate amount. The details will appear in the ESTIMATE DETAILS screen during the bolus programming steps.
* Insulin Activity Data
graph adapted from Mudaliar and colleagues, Diabetes Care,Volume 22,Number 9 September 1999,page 1501
* Active insulin only reduces the correction portion of the estimate, not the food portion.
* If the active insulin is more than the correction estimate, the correction portion of the estimate will be changed to zero(0).
* If the current BG is lower than target, the correction portion of the estimate will reduce the total estimate.
* If a Dual Wave bolus is less than the estimate due to the max bolus limit or user change, the square(sq)portion is reduced first.
Bolus Wizard examples:(settings:) Carb ratio: 30 grams/unit
Insulin
sensitivity: 40 mg/dL/unit
Target BG: 120 mg/dL
#1:No previous bolus activity for at least 10 hours. User inputs 60 grams of carbs and does not enter BG.
116
estimate = 2 units
#2:No previous bolus activity for at least 10 hours. User inputs 60 grams of carbs and a BG of 200.
estimate = 2 + 2 = 4 units
#3:No previous bolus activity for at least 10 hours. User inputs 60 grams of carbs and a BG of 80.
estimate = 2 +(-1) = 1 unit
#4: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.
estimate = 2 + 0.5 = 2.5 units
#5: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.
estimate = 2 + 0 = 2.0 units
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Default settings
Menu
Bolus
Menu:
Basal
Menu:
Utilities
Menu:
Item
Default Setting
*Bolus wizard:
Off
Dual/Square bolus:
Off
Maximum bolus:
10.0 u/h
Schemes
Off
Maximum basal rate:
2.0 u/h
Basal rate:
0.0 u/h
Temp basal type:
U/H
(Alarm)
(no defaults)
History:
Low reservoir warning:
(20)insulin units
(Time/Date)Date:
2011-11-28
(Time/Date)Time
format:
24-hour
Block:
Off
Language:
English
Limits
Increments
0 - 25 u(per single
bolus)
0.1u
0.0 - 35.0 u/h
0.1u
0.1u
max basal rate setting
0.1u/h (or 1%)
0 - 300 g/u or
0 - 20.0 u/exch
3 - 75 g/u or
0.2 - 5.0 u/exch
10 - 250 mg/dL or
0.5 - 13.9 mmol/L
80 - 160 mg/dL or
4.4 - 8.9 mmol/L
1 g/u or
0.5 u/exch
1 g/u or
0.1 u/exch
1 mg/dL or
0.1 mmol/L
1 mg/dL or
0.1 mmol/L
(*Bolus Wizard settings)
carb units:
ins to carb(or exch)ratio:
(insulin)sensitivity:
BG target:
grams or
exchanges
15 grams/u or
1 units/exch
50 mg/dL or
2.8 mmol/L
100 mg/dL or
5.6 mmol/L
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Warning Limits
Menu map
119
Icon table
120
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