Wellion MICRO-PUMP User manual

INSULIN PUMP SYSTEM
MANUAL

2
Foreword
Thank you for choosing the Wellion MICRO-PUMP insulin pump system. We believe
that the Wellion MICRO-PUMP will help you gain better control of your diabetes and
will help you live a healthy and active life.
This user guide is designed to help you understand insulin pump therapy and the
operation of your Wellion MICRO-PUMP. We strongly recommend that you work
closely with your healthcare professional to ensure you understand the pump
functions and can begin therapy safely and eectively.

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Table of contents
Introduction 7
Indications 7
Patients 7
Contraindications 7
Before Use 8
How to Use This Guide 9
Getting Help 9
Prepare for Emergencies 9
Insulin Pump Precautions 10
Portable Diabetes Assistant (PDA) Precautions 11
Blood Glucose Test Module Precautions 11
Important Safety Information 12
Component Description 13
Pump System Components 13
Accessories 13
Getting Started 15
PDA Setup 15
Charging the Batteries 18
Settings Wizard 20
Home Screen 26
Lock Screen 29
Basal Rate Adjustment 31
Understanding Basal Rate 31
Base Basal Rate 31
Editing Basal Programs (List Display) 31
Editing Basal Programs (Graph Display) 35
Activating a Basal Program 36
Temporary Basal Rate 36

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Settings 38
Boluses 39
Understanding Boluses 39
Manual Boluses 39
Bolus Presets 40
Extended Boluses 41
Quick Bolus 43
Cancelling a Bolus 45
Settings 46
Therapy Setup 48
Infusion Set Setup 48
Removing the Infusion Set 50
Filling the Reservoir 50
Assembling Reservoir to Pump 52
Disassembling the Reservoir 53
Replacing the Pump 54
Replacing the Reservoir 58
Setup 58
The Built-in Blood Glucose Meter 62
Operating Principle 62
Application 62
Blood Sampling 62
Fingertip Testing 63
Lancet Removal 65
Ejecting Test Strips 66
Testing Blood Glucose 66
Comparing Meter and Lab Results 68

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Quality Control Tests 69
Entering Your Glucose Reading Manually 71
Settings 72
Blood Glucose Meter Troubleshooting 73
Bolus Calculator 74
Introduction 74
Using the Bolus Calculator 76
Settings 78
History 80
Viewing Your History 80
Historical Averages 81
General Settings 83
Time and Date 83
About the System 83
Language 84
Memory Card 84
Display 84
User Settings 84
Bluetooth 85
Additional Features 87
Audio Player 87
Auto-O 87
Food Database 87
Suspend/Resume 88
How to Suspend/Resume 88
Alarms and Troubleshooting 89

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Pump Alarms 90
PDA Alarms 92
Alarm System Delay 94
Maintenance 95
Cleaning 95
Avoid Extreme Temperatures 96
Avoid Immersion in Water 96
Test Strips 96
Control Solution 97
X-Ray, MRI, and CT Scans 99
Precautions 99
Wireless Connection 99
Disposal 100
Transportation 100
Storage 100
Other Considerations 101
Specications 102
General Specications 102
Delivery 103
Blood Glucose Meter 103
Bolus Calculator 104
Bolus Delivery 104
Infusion Precision 104
Occlusion Detection (Maximum Infusion Pressure) 105
Occlusion Alarm Time 105
Overdose/Underdose 105
Electromagnetic Compatibility 105
Appendix 111
Symbols 111

7
Introduction
Indications
This product is intended for subcutaneous (beneath the skin) delivery of insulin at
set and variable rates for the management of diabetes mellitus in persons requiring
insulin and for the quantitative measurement of glucose in fresh whole capillary
blood (in vitro).
Patients
• This insulin pump system is suitable for patients with diabetes requiring short-
term or long-term insulin pump therapy.
• The blood glucose test function of the portable controller is suitable for
measuring the blood sugar level of whole blood samples that meet the following
requirements:
1. Hematocrit range of 30% to 55%.
2. Triglyceride concentration does not exceed 3.000 mg/dL (33,9 mmol/l) or
cholesterol concentration does not exceed 500 mg/dL (12,8 mmol/l).
3. Non-critically ill patients (such as those with severe dehydration or
ketoacidosis, etc.).
Contraindications
This insulin pump system is NOT suitable for patients who:
• Are unwilling to receive insulin treatment.
• Are unable to control their blood glucose, or unwilling to implant a cannula.
• Suer from alcoholism, drug abuse, severe mental disorders (such as depression,
schizophrenia).
• Suer from allergies, including allergies to insulin and severe skin irritation.
• Are unconscious.
• Unable to understand or master insulin therapy concepts.
• Have severe hearing or vision impairment.
• Are elderly and living alone.
• Are children too young to administer diabetes therapy themselves.

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Before Use
BeforestartingtouseyourWellionMICRO-PUMPsystem,yourhealthcareprofessional
should provide some important information regarding the management of your
diabetes. If you have further questions regarding this information, please contact
your healthcare professional for more guidance.
1. Basal Rate
Basal insulin is administered to maintain target blood glucose levels when not
eating.You can congure up to three basal programs with theWellion MICRO-PUMP,
which can help you adapt to dierent situations (for example, workdays, weekends,
and sick days). Each basal program can be congured with up 48 scheduled basal
rate changes within one day. However, if you are new to using an insulin pump, you
may decide to only use one or two basal rates during the day.
2. Active Insulin Time
The length of time that insulin remains active and available in your body after a
correction bolus. Quick acting U100 Insulin should be used in the pump.
3. Target Blood Glucose Level
Insulin pump therapy requires a target blood glucose level. The purpose of an
insulin pump is to keep the patient’s blood glucose within a target blood glucose
level range.
4. Insulin Sensitivity Factor
How much one unit of insulin can decrease blood glucose level. This number is used
to calculate bolus injection amounts.
5. Carbohydrate Ratio
The number of grams of carbohydrates that can be covered or disposed by 1 unit
of insulin.

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How to Use This Guide
We recommend that you read this user guide thoroughly. Your healthcare
professional can help you understand the usage in even greater detail. Please read
this user guide carefully in the correct chapter order. In many cases subsequent
chapters refer to information detailed in previous chapters.
Note: This user guide shows sample screens only. Your Portable Diabetes
Assistant (PDA) screens may be slightly dierent.
Getting Help
This user guide describes the insulin pump system in great detail. However, you
should still consult with your healthcare provider for guidance. New users should
consult a healthcare professional to help with rst time setup and training of the
insulin pump system.
Please seek help from your healthcare professional if you encounter problems.
Your local Wellion provider can provide technical support for the device, but cannot
provide treatment advice for your medical condition.
Prepare for Emergencies
Patients with diabetes should always carry an emergency kit to quickly respond to
any diabetes emergencies. Your emergency kit should include the following items:
• Blood glucose test strips
• Ketone test supplies
• 1-2 sets of pump disposables (reservoirs, infusion sets, etc.)
• PDA and Pump battery chargers
• Alcohol prep swabs
• Backup pump battery
• Vial of rapid acting U-100 insulin that is approved for your pump
• Syringes for manually injecting insulin
• Glucose tablets or another fast-acting source of carbohydrates

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• Instructions from your healthcare provider about how much insulin to administer
if the pump is interrupted as well as your healthcare provider/doctor’s phone
number in case of emergency
Insulin Pump Precautions
The pump is used to administer insulin for people with diabetes. If it is used
improperly, it could cause life-threatening situations.
• Before using the pump, please read the user guide carefully. Patients must be
trained by a professional healthcare provider and should only use the pump
after they have mastered the operation.
• Your healthcare professional should develop a custom insulin delivery scheme
made for you. Your healthcare professional will adjust the settings and observe
the eectiveness, possibly monitoring your blood glucose four times a day until
the therapy is stable.
• You should keep in frequent contact with your healthcare professional. Basic
pump adjustments should be made only under close supervision with a qualied
person.
• You should have sucient knowledge of diabetes, and how to regulate your
blood glucose level using insulin delivery and diet. You should understand the
eects of hyper and hypoglycemia and how to prevent these conditions.
• If the pump fails to deliver your needed insulin, immediately stop using the
system and consider using your emergency kit to supplement insulin. Contact
your healthcare provider and/or local Wellion support.
• Please be sure to operate in strict accordance with this instruction manual,
because failure to follow the instructions can cause problems. The company will
try to assist, but does not bear the various related legal obligations arising from
misuse.
This product can only be used to administer U-100 insulin.
Only Wellion disposable supplies should be used with the pump.

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Portable Diabetes Assistant (PDA) Precautions
The PDA is the main interface for the entire system. Please note the following
precautions:
• Do not let others handle your PDA, except your qualied healthcare professional.
• Please keep the battery charged.
• Do not drop or get wet as this could cause a malfunction.
Blood Glucose Test Module Precautions
• This module should only be used in vitro and can only be used with Wellion
MICRO blood sugar test strips. Use of other brand test strips will result in
incorrect test results.
• The blood glucose test function can only be used to determine blood glucose
levels using whole blood samples. Do not use serum or plasma samples.
• The blood glucose test function is not intended for neonatal applications.
• Test results may not be accurate for blood hematocrit of more than 55% or
below 30%.
• Blood containing high levels of vitamin C or other reducing agents can lead to
inaccurate results.
• The blood glucose meter test range is 1,1-33,3mmol/L (20-600 mg/dL).
• Triglycerides above 3,000 mg/dL (33,9 mmol/l) and cholesterol above
500 mg/dL (12,8 mmol/l) will lead to inaccurate test results.
• Patients with serious illness (such as severe dehydration or ketoacidosis) are not
suitable for measuring blood sugar using the blood sugar test system.
• The blood glucose meter is only suitable for clinical screening tests or family self-
monitoring. The test results cannot be referred to as conrmed cases. In order to
ensure the accuracy of the results, the test results can be further conrmed by
other methods, such as biochemical methods.
• As with all diagnostic reagents, test results must be linked with a professional
doctor’s diagnosis from the other clinical symptoms.
• Carefully process waste caused by blood glucose tests according to the relevant
local laws and regulations, because blood samples are considered a biohazard.

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Important Safety Information
Do Not Immerse the Pump in Water
The pump is splashproof (IPX4). Do not fully submerge the pump in water. If you
plan to bathe, swim, or participate in other water activities, please suspend insulin
delivery and remove the pump from the base. After you nish your activities, you
may re-apply the pump to the base and continue pump therapy.
If the pump is accidentally dropped in water, use a soft clean towel to dry the
pump as soon as possible. If you believe that water has entered the pump, or if you
observe any other possible pump malfunction, please remove the pump from the
base, check your blood glucose level and take precautions as necessary. 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.
Static Electricity
The insulin pump system is resistant to normal levels of static electricity (ESD), but
high levels of shock may cause a software reset which can interrupt insulin delivery.
ESD are more likely in situations where the relative humidity is very low, such as
inside a heated building during the winter in areas where it is cold outside. If you
suspect that your pump has failed, follow the instructions listed in Chapter: Alarms
and Troubleshooting.

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Component Description
Pump System Components
Portable Diabetes Assistant (PDA) Pump
Bolus Button Motor
System
Battery
contacts
Accessories
1. Cannula Inserter 2. Pump Battery 3. Pump Battery Charger

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Warning: Use only accessories and disposables that are manufactured by the
manufacturer, or with the Wellion MICRO brand name. Use of non-
standard components can be unsafe
4. PDA Charger 5. PDA Charging Cable
Warning: The included charger can be used in wall outlets rated at AC 110V-250V
50- 60Hz. Connection to outlets that are outside this range can cause
damage.
Note: Only use electrical components and accesso-ries branded Wellion. Other
accessories may lead safety problems, including inaccurate insulin delivery.
The manufacturer and MED TRUST cannot be liable for problems arising
from the use of third-party accessories
• Pump (MTM-1)
• Portable Diabetes Assistant (PDA) (MTM-2)
• Cannula Inserter
• Pump Battery
• Pump Battery Charger
• PDA Charger
• PDA Charging Cable

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Figure 1
Finger Hold
3. Insert the Battery:
Install the battery in the orientation shown in
Figure 3.
Figure 2
Note: The microSD memory card must be
inserted with the battery removed. A
microSD card is not provided with your
pump package, but you may provide
your own. You can use your PDA also
without microSD memory card.
Figure 3
Note: Use only batteries and chargers
supplied by the manufacturer. Use
of third party accessories may cause
unexpected behavior and will void
your warranty.
Getting Started
PDA Setup
1. Remove the battery cover:
Holding the PDA rmly with one hand, pry up
the battery cover by inserting your ngernail
until the slot shown in Figure 1.
2. Insert a microSD memory card:
Insert memory into the slot as shown in Figure 2.
4. Replace the Battery Cover:
Replace the battery cover to the position shown
in Figure 4.The battery cover should be attached
securely around the perimeter of the PDA, and
you may hear a snap sound as the hooks engage.
Figure 4

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5. The PDA controls are shown in Figure 5:
Note: The PDA display will also turn o and enter standby mode after a preset
time. See Chapter User Settings for more information.
1. (Power Button)
Power ON: Press and hold this key and the PDA will vibrate, begin the startup
process, and enter the home screen after about 30 seconds.
Screen O: If the PDA display is on, pressing the Power Button will turn o the
LCD display and the PDA will enter standby mode.
1 10 11
59
7
8
6
234
12
13
Figure 5
Screen On: When in standby, pressing the power button will turn on the display
and present the lock screen.

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Note: The help button works in the Home, Basal, Bolus and History screens.
Note: Some functions, such as the change reservoir wizard, will not allow you to
return to the home screen or return to a previous screen before completion.
Power OFF: If the display is on, press and hold the power button to open a
dialogue box to conrm that you would like to turn o the device.
2. (Help Button)
If you need help with commands or functions of the PDA, you can press the help
button for more information.
3. (Home Screen Button)
Press this to return to the home screen.
4. (Back Button)
Press this to return to the previous screen, or close a dialog box.
5. (Up Button)
This can be used to navigate the interface without using the touchscreen. Choose
up to change selection.
6. (Down Button)
This can be used to navigate the interface without using the touchscreen. Choose
down to change selection.
7. (Enter (Select) Button)
This can be used to navigate the interface without the touchscreen. Choose the
Enter button to select an action.
Note: The Enter button also can be used for special functions, as explained in
subsequent chapters.

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Note: Use only batteries and chargers from the manufacturer. Use of third party
accessories may cause unexpected behavior and will void your warranty.
Charging the Batteries
The pump and PDA batteries should be fully charged before use.
PDA Charger
1. The PDA battery can only be charged while inside the PDA. The PDA may be on
or o during the charging process, however, the battery will charge faster if the
controller is o.
8. Display
3.2 inch color display with touchscreen.
9. Charger/Data Port
Connect the PDA charger to this port to replenish the battery. This port can also be
used to transfer data to a personal computer using a data cable.
10.Blood Glucose Test Strip Port
Inserting the correct Wellion MICRO blood glucose test strip into this port will
activate the blood glucose test menu. For more information on how to use the
blood glucose meter, refer to Chapter The Built-in Blood Glucose Meter.
11.Headphone Jack
3.5mm Headphone Jack
12.Test Strip Ejector
Used to eject a blood glucose test strip. See Chapter Ejecting Test Strips.
13.Speaker

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Figure 6
2. Insert the small end of the cable into the PDA, and
the large end of the cable into the PDA charger as
shown in Figure 6.
3. Connect the PDA charger to a power outlet. If
the PDA is on, the battery icon will change to the
charging icon. If the PDA is o, a charging animation
will appear.
Note: If the PDA battery charger does not work, do
not try to repair. Please contact your dealer for
repair or replacement.
Pump Battery Charger
1. The pump battery is inserted into the charger as
shown in Figure 7. You should hear a click sound
indicating that the battery is correctly inserted.
2. Insert the small end of the cable into the pump
battery charger as shown in Figure 8. The large
end of the cable should be inserted into the PDA
charger.
3. Plug the PDA charger into a wall outlet, and the
blue LED will turn on, indicating that the battery
is charging. The indicator will ash if the charger is
faulty.
4. When the battery is fully charged, the blue LED will
turn o and you can disassemble the cable, pump
battery charger, and PDA charger.
Figure 7
Figure 8

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Figure 9
Note: If the battery is fully charged, do not leave it
inside the charger while disconnected from a
wall outlet. Doing so may slowly deplete the
battery.
Note: A full battery should be stored properly inside
an insulated package. Storing a battery with
metal objects may cause a short circuit,
resulting in a decrease in capacity or even
battery damage.
Warning: Do not touch any metal part of the charger when plugged into a wall
outlet as it is a potential shock hazard.
5. Remove the pump battery as shown in Figure 9: lift
the battery up from the charger groove.
Note: When you are in the Settings Wizard, the Home
button and Back button will not work until
you nish the Wizard.
1. Time and Date Settings
After entering the Settings Wizard, you will be
presented with the Time and Date setup screen shown
in Figure 10.
Settings Wizard
Turn on the PDA by pressing the power button. The
rst time you turn on the PDA, you will see the Settings
Wizard which will guide you through basic setup
options.
Figure 10