EQUILAB MTM-I User manual

®
Patch Insulin Pump System MTM-I
Patch Insulin Pump System
Instruction Manual

1 Foreward 1
2 Brief Introduction 1
2.1 Indications 1
2.2 Patients 1
2.3 Contraindications 2
2.4 Before Use 2
2.5 How to Use This Guide 3
2.6 Getting Help 3
2.7 Prepare for Emergencies 4
2.8 Insulin Pump Precautions 4
2.9 Portable Diabetes Assistant
(PDA) Precautions 5
2.10 Blood Glucose Test Module
Precautions 5
2.11 Important Safety Information 6
3 Component Descriptions 8
3.1 Pump System Components 8
3.2 Accessories 8
4 Getting Started 11
4.1 PDA Setup 11
4.2 Charging the Batteries 15
4.3 Settings Wizard 17
4.4 Home Screen 24
4.5 Lock Screen 27
5 Basal Rate Adjustment 29
5.1 Understanding Basal Rate 29
5.2 Base Basal Rate 29
5.3 Editing Basal Programs (List Display） 29
5.4 Editing Basal Programs (Graph Display） 33
5.5 Activating a Basal Program 34
5.6 Temporary Basal Rate 35
5.7 Settings 36
6 Boluses 38
6.1 Understanding Boluses 38
6.2 Manual Boluses 38
6.3 Bolus Presets 39
6.4 Extended Boluses 41
6.5 Quick Bolus 44
6.6 Canceling a Bolus 46
6.7 Settings 47
Table of Contents

7 Therapy Setup 49
7.1 Infusion Set Setup 49
7.2 Removing the Infusion Set 51
7.3 Filling the Reservoir 51
7.4 Assembling Reservoir to Pump 54
7.5 Disassembling the Reservoir 55
8 Replacing the Patch Pump 56
9 Replacing the Reservoir 64
9.1 Setup 64
10 The Built-in Blood Glucose Meter 70
10.1 Operating Principle 70
10.2 Application 70
10.3 Blood Sampling 70
10.4 Lancet Removal 73
10.5 Ejecting Test Strips 75
10.6 Testing Blood Glucose 75
10.7 Comparing Meter and Lab
Results 77
10.8 Quality Control Tests 78
10.9 Entering Your Glucose
Reading Manually 81
10.10 Settings 82
10.11 Blood Glucose Meter
Troubleshotting 84
11 Bolus Calculator 85
11.1 Introduction 85
11.2 Using the Bolus Calculator 86
11.3 Settings 89
12 History 91
12.1 Viewing Your History 91
12.2 Historical Averages 93
13 General Settings 95
13.1 Time and Date 95
13.2 About the System 95
13.3 Language 96
13.4 Memory Card 96
13.5 Display 96
13.6 User Settings 97
13.7 Bluetooth 97
14 Additional Features 100

14.1 Audio Player 100
14.2 Auto-Off 100
14.3 Food Database 100
15 Suspend/Resume 101
15.1 How to Suspend/Resume 101
16 Alarms and Troubleshooting 103
16.1 Patch Pump Alarms 105
16.2 PDA Alarms 106
16.3 Alarm System Delay 107
17 Maintenance 108
17.1 Cleaning 108
17. 2 Avoid Extreme Temperatures 108
17. 3 Avoid Immersion in Water 109
17.4 Test Strips 109
17. 5 Control Solution 110
17.6 X-Ray, MRI, and CT Scans 112
17.7 Wireless Connection 112
17. 8 Precautions 112
17.9 Disposal 113
17.10 Transportation 113
17.11 Storage 113
17.12 Other Considerations 114
18 Specifications 115
18.1 General Specifications 115
18.2 Delivery 116
18.3 Blood Glucose Meter 116
18.4 Bolus Calculator 117
18.5 Bolus Delivery 117
18.6 Infusion Precision 117
18.7 Occlusion Detection
(Maximum Infusion Pressure) 118
18.8 Occlusion Alarm Time 118
18.9 Overdose/Underdose 118
18.10 Electromagnetic
Compatibility 119
19 Appendix 124
19.1 Symbols 124

Equil® Patch Insulin Pump System
1
1 Foreward
Thank you for choosing the Equil®
patch insulin pump system. We believe
that Equil® 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 Equil® patch 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
effectively.
2 Introduction
2.1 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).
2.2 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:
1Hematocrit range of 30% to 55%.
2Triglyceride concentration does
not exceed 3,000 mg/dL or cholesterol

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Equil® Patch Insulin Pump System
concentration does not exceed 500 mg/dL.
3Non-critically ill patients (such as those
with severe dehydration or ketoacidosis,
etc.).
2.3 Contraindications
Patients who:
•Are unwilling to receive insulin
treatment.
•Are unable to control their blood
glucose, or unwilling to implant
a cannula.
• Suffer from alcoholism, drug
abuse, severe mental disorders (such as
depression,schizophrenia).
•Suffer 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.
2.4 Before Use
Before starting to use your Equil
system, your healthcare professional
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.
Basal Rate
Basal insulin is administered to
maintain target blood glucose levels
when not eating. You can configure up to
three basal programs with Equil, which
can help you adapt to different situations
(for example, workdays, weekends, and
sick days). Each basal program can be
configured 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.
Active Insulin Time
The length of time that insulin
1
2

Equil® Patch Insulin Pump System
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remains active and available in your body
after a correction bolus. Quick acting U100
Insulin should be used in the pump.
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.
Insulin Sensitivity Factor
How much one unit of insulin can
decrease blood glucose level. This number
is used to calculate bolus injection
amounts.
Carbohydrate Ratio
The number of grams of
carbohydrates that can be covered or
disposed by 1 unit of insulin.
2.5 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.
2.6 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 first time setup and training of the
insulin pump system.
Please seek help from your healthcare
professional if you encounter problems.
MicroTech can provide technical support
for the device, but cannot provide
treatment advice for your medical
condition.
4
5
This user guide shows sample
screens only. Your personal
diabetes controller (PDA) screens
may be slightly different.
Note
3

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Equil® Patch Insulin Pump System
2.7 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
•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
2.8 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
effectiveness, 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 under
close supervision with a qualified person.
•You should have sufficient knowledge
of diabetes, and how to regulate your
blood glucose level using insulin delivery
and diet. You should understand the

Equil® Patch Insulin Pump System
5
effects 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 MicroTech
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 MicroTech Medical disposable
supplies should be used with the pump.
2.9 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 qualified healthcare
professional.
•Please keep the battery charged .
•Do not drop or get wet as this could
cause a malfunction.
2.10 Blood Glucose Test Module
Precautions
•This module should only be used in
vitro and can only be used with MicroTech's
Exactive EQ 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

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Equil® Patch Insulin Pump System
inaccurate results.
•The blood glucose meter test range is
1.1-33.3mmol/L (20-600 mg/dL).
•Triglycerides above 3,000 mg/dL and
cholesterol above 500 mg/dL 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 confirmed cases.
In order to ensure the accuracy of the
results, the test results can be further
confirmed 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.
2.11 Important Safety
Information
2.11.1 Do Not Immerse the
Pump in Water
The patch pump is water resistant
and 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 finish 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

Equil®Patch Insulin Pump System
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professional if you experience excessively
high or low blood glucose levels, or if you
have any questions about your care.
2.11.2 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 16: Alarms and Troubleshooting.
2.11.3 FCC Information
This equipment has been tested and found
to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable
protection against harmful interference in a
residential installation.This equipment generates,
uses and can radiate radio frequency energy and,
if not installed and used in accordance with the
instructions, may cause harmful interference to
radio communications.
However, there is no guarantee that interference
will not occur in a particular installation.If
this equipment does cause harmful interference to
radio or television reception, which can be
determined by turning the equipment off and on,
the user is encouraged to try to correct the
interference by one or more of the following
measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and
receiver.
Connect the equipment into an outlet on a circuit
different from that to which the receiver is
connected.
Consult your local RadioShack store or an
experienced radio/TV technician for help.
Changes or modifications not expressly approved by
the party responsible for compliance could
void the user's authority to operate the equipment.
This device complies with part 15 of FCC Rules.
Operation is subject to the following two conditions:
（1）This device may not cause harmful
interference, and （2）this device must accept any
interference received, including interference that
may cause undesired operation.
•
•
•
•

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Equil® Patch Insulin Pump System
3 Component Descriptions
3.1 Pump System Components
3.2 Accessories
Cannula Inserter
Portable Diabetes Assistant (PDA)
1
Battery Contacts
Motor System
Bolus Button
Patch Pump

Equil® Patch Insulin Pump System
9
Pump Battery
Pump Battery Charger
PDA Charger
PDA Charging Cable
2
3
Use only accessories and disposables
that are manufactured by MicroTech
Medical, or with the Equil brand name.
Use of non-standard components can
be unsafe.
Warning
！
4
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.
Warning
！
5

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Equil® Patch Insulin Pump System
•Patch Pump：MTM-1
•Portable Diabetes Assistant (PDA):
MTM-2
•Cannula Inserter
•Pump Battery
•Pump Battery Charger
•PDA Charger
•PDA Charging Cable
Only use MicroTech's electrical
components and accessories. Other
accessories may lead safety problems,
including inaccurate insulin delivery.
MicroTech cannot be liable for problems
arising from the use of third party
accessories
Note

Equil® Patch Insulin Pump System
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4 Getting Started
4.1 PDA Setup
1Remove the battery cover: Holding
the PDA firmly with one hand, pry up
the battery cover by inserting your
fingernail until the slot shown in
Figure 4.
Figure 4
2Insert a microSD memory card:
Insert memory into the slot as shown
in Figure 5.
Figure 5
Finger Hold
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. The microSD
card is not needed for the primary functions
of the pump system. However, secondary
functions such as data transfer capability and
MP3 player functions will not work correctly
without a memory card inserted.
Note

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Equil® Patch Insulin Pump System
3Insert the Battery: Install the
battery in the orientation shown in
Figure 6.
Figure 6
4Replace the Battery Cover:
Replace the battery cover to the
position shown in Figure 7. 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 7
5The PDA controls are shown in
Figure 8：
Use only batteries and chargers from
MicroTech Medical. Use of third party
accessories may cause unexpected
behaviour and will void your warranty.
Note

Equil® Patch Insulin Pump System
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Figure 8
（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 Off: If the PDA display is on,
pressing the Power Button will turn off the
LCD display and the PDA will enter standby
mode.
Screen On: When in standby, pressing the
power button will turn on the display and
present the lock screen.
Power Off: If the display is on, press and
hold the power button to open a dialogue
box to confirm that you would like to turn
off the device.
（Help Button）
If you need help with commands or
functions of the PDA, you can press the
The PDA display will also turn off and
enter standby mode after a preset time.
See Section 13.6 for more information.
Note
1
5
6
9
7
8
2 3 4
10 11 1
2
12
13

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Equil® Patch Insulin Pump System
help button for more information.
（Home Screen Button）
Press this to return to the home screen.
（Back Button）
Press this to return to the previous screen,
or close a dialog box.
（Up Button）
This can be used to navigate the interface
without using the touchscreen. Choose up
to change selection.
（Down Button）
This can be used to navigate the interface
without using the touchscreen. Choose
down to change selection.
（Enter (Select) Button）
This can be used to navigate the interface
without the touchscreen. Choose the
Enter button to select an action.
Display
3.2 inch color display with touchscreen.
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.
Blood Glucose Test Strip Port
Inserting the correct MicroTech 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 10.
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.
Note
The Enter button also can be used
for special functions, as explained in
subsequent chapters.
Note
6
7
5
4
3
8
9
10
The help button works in the Home,
Basal, Bolus and History screens.
Note

Equil® Patch Insulin Pump System
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3.5mm Headphone Jack
Test Strip Ejector
Used to eject a blood glucose test strip.
See section 10.5 .
Speaker
4.2 Charging the Batteries
The patch pump and PDA batteries
should be fully charged before use.
4.2.1 PDA Charger
1The PDA battery can only be charged
while inside the PDA. The PDA may be
on or off during the charging process,
however, the battery will charge faster if
the controller is off.
2Insert the small end of the cable into the
PDA, and the large end of the cable into the
PDA charger as shown in Figure 9.
Figure 9
3Connect 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
off, a charging animation will appear.
11
12
13
Use only batteries and chargers from
MicroTech Medical. Use of third party
accessories may cause unexpected
behavior and will void your warranty.
Note

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Equil® Patch Insulin Pump System
4.2.2 Patch Pump Battery Charger
1The patch pump battery is inserted into
the charger as shown in Figure 10. You
should hear a click sound indicating that
the battery is correctly inserted.
Figure 10
2Insert the small end of the cable into the
pump battery charger as shown in Figure
11. The large end of the cable should be
inserted into the PDA charger.
Figure 11
3Plug the PDA charger into a wall outlet,
and the blue LED will turn on, indicating
that the battery is charging. The indicator
will flash if the charger is faulty.
4When the battery is fully charged,
the blue LED will turn off and you can
disassemble the cable, pump battery
charger, and PDA charger.
If the PDA battery charger does
not work, do not try to repair. Please
contact your dealer for repair or
replacement.
Note