EQUIL MTM-I Instruction Manual

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®
Patch Insulin Pump System
MTM-I
Patch Insulin Pump System
Instruction Manual
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Table of Contents
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
2.11 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
5.2 Base Basal Rate 29
5.3
Editing Basal Programs (List Display)
5.4
Editing Basal Programs (Graph Display)
5.5 Activating a Basal Program
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
29
29 33 34
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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
7.5
Disassembling the Reservoir 55
8 Replacing the Patch Pump
9 Replacing the Reservoir
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
54
56
64
Reading Manually
10.10 Settings 82
10.11 Blood Glucose Meter Troubleshotting
11 Bolus Calculator 85
11.1 Introduction 85
11.2 Using the Bolus Calculator
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
81
84
86
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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
16
Alarms and Troubleshooting
16.1 Patch Pump Alarms
16.2 PDA Alarms
16.3 Alarm System Delay 107
17
Maintenance 108
17.1
Cleaning 108
17. 2
Avoid Extreme Temperatures
17. 3
Avoid Immersion in Water
17.4
Test Strips 109
17. 5
Control Solution
17.6
X-Ray, MRI, and CT Scans
17.7
Wireless Connection 112
17. 8
Precautions 112
17.9
Disposal 113
17.10 Transportation 113
17.11 Storage 113
101
103
105
106
108
109
110
112
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
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1 Foreward
2 Introduction
Thank you for choosing the Equil patch insulin pump system. We believe that Equil of your diabetes and will help you live a healthy and active life.
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.
1
®
will help you gain better control
This user guide is designed to help
Equil® Patch Insu lin Pump System
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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 short­term or long-term insulin pump therapy.
The blood glucose test func tion of
•
the portable controller is suitable for measuring the blood sugar level of whole blood samples that meet the following requirements:
Hematocrit range of 30% to 55%.
1
Triglyceride concentration does
2
not exceed 3,000 mg/dL or cholesterol
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concentration does not exceed 500 mg/dL.
Non-critically ill patients (such as those
3
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 impor tant 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
1
Basal insulin is administered to maintain target blood glucose levels when not eating. You can conf igure 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
2
The length of time that insulin
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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.
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.
Insulin Sensitivity Factor
4
How much one unit of insulin can decrease blood glucose level. This number is used to calculate bolus injection amounts.
Carbohydrate Ratio
5
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.
Note
This user guide shows sample screens only. Your personal diabetes controller (PDA) screens may be slightly different.
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.
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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
Instruc tions 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 suf ficient knowledge
•
of diabetes, and how to regulate your blood glucose level using insulin delivery and diet. You should understand the
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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 func tion can
•
only be used to determine blood glucose levels using whole blood samples. Do not use serum or plasma samples.
The blood glucose test func tion 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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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 obser ve any other possible pump malfunction, please remove the pump from the base, check your blood glucose level and take precautions as necessar y. Symptoms of high blood glucose include fatigue, excessive thirst and nausea. You should always contact your healthcare
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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 deliver y.
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 suspec t that your pump
ailed,follow the instruc tions listed in
has f
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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Component Descriptions
3
Pump System Components
3.1
Porta ble Diabetes A ssistant (PDA)
Patch Pump
Bolus But ton
3.2 Accessories
1
Cannula Inserter
Batter y Contacts
Motor Syste m
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2
Pump Battery
Pump Battery Charger
3
Warning
!
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.
4
PDA Charger
Warning
!
The included charger can be used in wall outlets rated at AC 110V-250V 50­60Hz. Connection to outlets that are outside this range can cause damage.
PDA Charging Cable
5
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Note
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
Patc h Pump:M TM-1
•
Portable Diabetes Assistant (PDA):
•
MTM-2
Cannula Inserter
•
Pump Battery
•
Pump Battery Charger
•
PDA Charger
•
PDA Charging Cable
•
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4 Getting Started
4.1 PDA Setup
1
Remove 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.
Finger Ho ld
Figure 4
2
Insert a microSD memory card: Insert memory into the slot as shown in Figure 5.
Figu re 5
Note
The micr oSD memory card m ust be inser ted with the bat tery removed . A microSD card is no t provided with yo ur pump packag e, but you may p rovide your own. T he microSD card is no t needed for the p rimary func tions of the pum p system. Howeve r, s econdary funct ions such as data tr ansfer capab ility and MP3 player f unctions wil l not work correc tly withou t a memory card i nserted.
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3
Insert the Battery: Install the battery in the orientation shown in Figure 6.
Figu re
6
Note
Use only batteries and chargers from MicroTech Medical. Use of third party accessories may cause unexpected behaviour and will void your warranty.
4
Replace 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.
Figu re
7
5
The PDA controls are shown in Figure 8:
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10 11
1
1
(Power Button)
Power On:Press and hold this key and the PDA will vibrate, begin the startup process,
5
6
9
7
8
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.
Note
The PDA display will also turn off and
2 3 4
enter standby mode after a preset time. See Section 13.6 for more information.
Figu re
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12
13
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.
2
(Help Button)
8
If you need help with commands or functions of the PDA, you can press the
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help button for more information.
Note
The help button works in the Home,
Basal, Bolus and History screens.
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.
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.
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.
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 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.
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3.5mm Headphone Jack
11
12
Test Strip Ejector Used to eject a blood glucose test strip. See section 10.5 .
13
Speaker
4.2 Charging the Batteries
The patch pump and PDA batteries
should be fully charged before use.
Note
Use only batteries and chargers from MicroTech Medical. Use of third party accessories may cause unexpected behavior and will void your warranty.
Insert the small end of the cable into the
2
PDA, and the large end of the cable into the PDA charger as shown in Figure 9.
4.2.1 PDA Charger
The PDA battery can only be charged
1
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 of f.
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Figu re
9
Connect the PDA charger to a power
3
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.
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Note
If the PDA battery charger does not work, do not try to repair. Please contact your dealer for repair or replacement.
4.2.2
Patch Pump Battery Charger
The patch pump battery is inserted into
1
the charger as shown in Figure 10. You should hear a click sound indicating that the battery is correctly inserted.
Figu re 10
Insert the small end of the cable into the
2
pump battery charger as shown in Figure
11. The large end of the cable should be inserted into the PDA charger.
Fig u re 11
Plug the PDA charger into a wall outlet,
3
and the blue LED will turn on, indicating that the battery is charging. The indicator will flash if the charger is faulty.
When the battery is fully charged,
4
the blue LED will turn off and you can disassemble the cable, pump battery charger, and PDA
charger.
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Remove the pump battery as shown
5
in Figure 12: lift the battery up from the charger groove
.
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.
Figu re 12
Note
A full battery should be stored properly inside an insulated package. Storing a bat tery with metal objects may cause a short circuit, resulting in a decrease in capacity or even batter y damage.
Warning
!
Do not touch any metal part of the charger when plugged into a wall outlet as it is a potential shock hazard.
4.3 Settings Wizard
Turn on the PDA by pressing the power button. The first time you turn on the PDA, you will see the Settings Wizard which will guide you through basic setup options.
Note
When you are in the Settings Wizard, the Home button and Back button will not work until you finish the Wizard.
Time and Date Settings
1
After entering the Settings Wizard, you will be presented with the Time and Date setup screen shown in Figure 13.
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Figu re 13
a) Choose the Date setting to open a dialog
box (Figure 14) that can be used to input the correct date. Use the “+” and “-” buttons to selec t the date, choose OK to save and exit or Cancel to exit without saving.
Figu re 14
b) Choose the Time setting to open a dialog
box (Fig. 15) that can be used to input the time. Use the “+” and “-“ buttons to select the time, choose OK to save and exit or Cancel to exit without saving.
Figu re 15
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Note
If the 12 hour format is chosen, am
and pm will be shown.
Figu re 16
c) If 24-Hour Format is checked, the time
and history data will be displayed in 24 hour format. Uncheck the box to use 12­hour format.
2
Basic Basal Settings
The second screen in the Settings Wizard shows the basic basal settings (Figure 17).
Note
For a more detailed description of
basal rates, see Section 5.1
a) Choose the Maximum Basal Rate setting
to open a dialog box (Figure 18) that can be used to input the maximum basal rate. Use the “+” and “-“ buttons to select
Figu re 17
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the appropriate maximum rate. Choose “OK” to save and exit or “Cancel” to exit without saving.
Note
Figu re 18
This feature is used to limit the maximum amount of basal delivery that can be administered by accident or misoperation.
b) Choose the Base Basal Rate setting to
open a dialog box (Figure 19) that can be used to input your base basal rate. Use the “+” and “-“ buttons to select the appropriate value. Choose OK to save and exit or Cancel to exit without saving.
Note
Figu re 19
This value is the most frequently used basal rate, and all other rates will be calculated based on this base rate.
c) Choose the Temporary Basal Rate
setting to open a dialog box (Figure 20) that will give you options.
Off: Temporary basal rates are disabled. The temporary basal rate controls will be greyed out.
U/hr: Temporary basal rates will be displayed in units of insulin delivered per hour.
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%: Temporary basal rates will be displayed relative to your current basal rate.
Figu re 20
After you have finished choosing the Basic Basal settings, choose Nex t to enter the third Settings Wizard screen, or Previous to enter the previous setting screen.
Basic Bolus Settings
3
The third screen in the Settings Wizard shows the Basic Bolus settings (Figure 21).
Note
Figu re 21
For a more detailed description of
boluses, see Section 6.1
The Bolus Increment setting (Figure 22)
a)
allows you to set the interval used when increasing or decreasing bolus amounts.
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Figu re 22
b) The Maximum Bolus setting allows you
to set an upper limit on the amount of insulin given in a single bolus (Figure 23). Use the “+” and “-“ buttons to select the value. Choose OK to save and exit or Cancel to exit without saving.
Figu re 23
Note
This feature is used to limit the maximum amount of bolus delivery that can be administered by accident or misoperation.
c) Choose the Extended Bolus setting to
open a dialog box (Figure 24) that will give you options. Off: Extended Bolus function is disabled. Extended Bolus controls will be greyed out. U: Amount now will be shown in U (units of Insulin). %: Amount now will be shown as a percentage of the entire bolus.
Figu re 24
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After you have finished choosing the Basic Bolus settings, choose Nex t to enter the fourth Settings Wizard screen, or Back to enter the previous setting screen.
4
Advanced Bolus Settings
The fourth screen in the Settings Wizard shows the Advanced Bolus Settings (Figure
25).
Figu re 25
a) The Quick Bolus function allows the
user to administer a bolus using only one button. This feature is turned off by default. For more detailed information about this feature, see Section 6.7
b) The Bolus Calculator can help the user
decide on the size of a bolus by taking into account blood glucose levels and other parameters. This feature is turned off by default. For more detailed information about this feature, see Section 11.3
Note
These two features are relatively advanced and MicroTech recommends proper training and practice before using these features.
After you have finished choosing the Advanced Bolus settings, choose Next to enter the f ifth Settings Wizard screen, or Previous to enter the previous setting screen.
5
Alert Options
The fif th screen in the Set tings Wizard shows the Alert Options (Figure 26). If you
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choose the Low Reser voir Alert Threshold setting, a dialog box will open that allows you to choose when the device will give you an alert warning when the amount of insulin remaining in the reservoir is low and that you should consider filling a new reservoir. Use the “+” and “-” buttons to select the appropriate value.
Figu re 26
After you have completed the Settings Wizard, choose Finish to finalize your settings and return to the Home Screen. To continue modifying set tings on previous screens, choose Previous.
Note
After you complete the Settings Wizard, you can use all of the basic functions of the pump system. However, please read the additional sections of this user guide as they describe the features in greater detail.
Note
After you complete the Settings Wizard for the first time, you may return to the Wizard by going to the Home Screen and choosing Settings and then Settings Wizard.
4.4 Home Screen
The Home Screen is shown in Figure 27. It is divided into three main sections: the Status Bar, Information Display Area, and Function Buttons.
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Status Bar Information Display Area
Function Buttons
Figu re 27
Status Bar:
The Status Bar contains icons that describe the status of the pump and PDA. The icons shown on the left are generally
related to the pump (blue), and the icons on the right are generally related to the PDA (green). Each Icon in the Status Bar is described below:
•
Username:Displays the name of the
user.
•
Insulin Pump Serial Number: Displays the serial number of the pump that is currently connected
•
Alert icon: If an alert appears, this
!
icon will appear on the status bar.
•
Insulin Remaining:Shows how much insulin remains by varying degree;if PDA
wireless link is poor it displays
•
Pump Battery Level:Shows the pump's batter y level status in var ying degrees; if PDA wireless link is poor, it displays? 。
•
Shows the wireless link strength between pump and PDA. It dispalys
connection is totally lost.
•
Blood Glucose Test Reminder
(BG Reminder):This icon will appear on the status bar if a Test Reminder has been programmed.
Wireless Link Status:
?
when the
!
。
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•
PDA Battery Level:Shows the PDA's batter y level status in var ying degree. If
thePDA is charging, it displays .
Press the button at the middle of the
Status Bar and it will enlarge as in Figure
28.
Figu re 28
Note
If more than one BG Reminder has been programmed, only the next BG Reminder is shown in the enlarged Status Bar. If no BG Reminders are programmed, nothing is shown.
Information Display Area:
Normally the Information Display Area shows the three most important pieces of information regarding your condition: your last blood glucose level, the last bolus administered, and the current basal rate. During special functions (bolus delivery, temporary basal rates, and suspend mode) the Information Display Area will show the status of those functions until the ac tions are completed.
Function Buttons:
Bolus: Pressing this button takes you to
1
the Bolus Screen where you can administer a normal or extended bolus.
Basal: Pressing this button takes you
2
to the Basal Screen where you can adjust your basal programs or star t a temporary
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basal rate.
Actions: Pressing this button takes
3
you to the Actions Screen where you can start a new reser voir, initiate a new pump, manually enter your blood glucose level, access the food library, or access the music player.
History:Takes you to therapy history
4
and historical averages.
Settings:Press this to go to the Settings
5
Menu.
Suspend/Resume: Pressing this button
6
allows you to quickly suspend or resume insulin delivery.
Note
For more detailed information, please refer to subsequent chapters of this user guide explaining the functions in greater detail.
4.5 Lock Screen
If you press the power button to turn
the display off, or the display turns off
automatically after a period of non-use, the display can be turned on again by pressing the power button. The PDA will enter the lock screen as shown in Figure 29.
Time and Date
Information Display Area
Unlock Area
Figure 29
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The Lock Screen is divided into three main sections: Time and Date, Information Display Area, and the Unlock Area.
Time and Date Display Area
Displays the current time, day, date and yea r.
Information Display Area
Shows your last blood glucose level, the last bolus administered, and the current basal rate; or that status of a special function.
Note
The content of the Information Display Area in the Home Screen is identical.
Unlock Area
Unlock the device by swiping from left to
right in this area.
Note
You can also unlock the PDA by simultaneously holding the Down and Enter buttons.
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5 Basal Rate Adjustment
5.1 Understanding Basal Rate
Basal insulin is the pump’s way to simulate the secretion of non-mealtime insulin. Even if a non-diabetic person fasts all day, there still is a small amount of insulin secreted. The pump’s basal insulin is used to simulate the micro-secretions of insulin.
5.2 Base Basal Rate
We have already set up the base basal rate in the Settings Wizard. The base basal rate is the default basal rate for your basal programs. In the next sec tions you will learn to edit a basal program by modifying the base basal rate in different time periods.
5.3
Editing Basal Programs (List
Display)
In the Home Screen, press the basal function button to enter the basal screen shown in Figure 30. You will see three Basal Program Tabs, a Basal Time Period List, and Basal Program Action buttons.
Basal Program Tabs
Basal Time Period List
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Basal Program Action Buttons
Figure 30
Page 34
Note
When the PDA is in portrait orientation, the List Display is shown. If the PDA is rotated into landscape orientation, you will enter the Graph Display. However, if you are editing a particular time period, rotating the display will not change the Display until you have completed the entry。
When you first use the Basal Screen, no basal program is active. If you choose to activate one of the three basal programs, the previous basal rate will automatically stop.
1
Browsing Settings
You can look at Basal Program Settings by reviewing the Basal Time Period List. Swipe up or down in this area to scroll and see hidden list entries.
Reviewing Basal Programs
2
The PDA provides the ability to run one of three basal programs. You can review different basal programs by choosing one of the Basal Program Tabs.
Quick Basal Program Setup
3
The pump provides a Quick Basal Program Setup option. By entering your total daily basal insulin and choosing a 6 or 24 hour time period, the PDA can automatically create a Basal Program for you.
Select the appropriate Basal Program Tab and the choose Change Settings to edit the program (Figure 31). Choose the top row and a window will pop-up for you to enter your total basal amount and which time period you would like (6 or 24 time periods). After entering these settings, the system will automatically assign Basal Time Periods to the Basal Program. Now you can fur ther edit the Basal Time Periods according to your needs.
Note
The Quick Basal Program Setup is only an estimate of your daily basal needs. Consult your doctor for more specific dosages.
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Figu re 31
screen as shown in Figure 32.
Editing Basal Programs
4
a) Add new basal rate:The base basal
rate was set in the Settings Wizard, so by default all 24 hours of the basal program are set to this delivery rate. To add a new basal time period, press the Change Settings button to enter the basal edit
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Figu re 32
Page 36
Press the button to add a new basal time period (Figure 33). After editing is
complete (Figure 34), the base rate time will automatically be divided into multiple time periods.
Figure 33
Figu re 34
b) Editing a basal time period: You can
edit a basal time period entr y by pressing the icon.
c)Deleting a basal time period: You can
delete a basal time period entry by pressing the icon. The time period will
revert to the base basal rate.
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Note
After deleting a basal time period, the PDA may merge adjacent basal time periods if the basal rates are the same.
Changing the Basal Program
5
Name
Press the Change Basal Program Name button to open the Change Name dialog box (Fig 35). Change to the desired name .
Figu re 35
Saving Settings
6
After you have completed editing the basal program, press Save Settings to save and exit the Basal Edit screen.
Note
If you have edited a basal program that is currently running on the pump, a dialog box will open asking if you would like to send the updated program to the pump. Choose OK to update and save or Cancel to return to the Basal Edit screen.
Note
If you press the Back button( ), while in the Basal Edit screen, a dialog box will open to confirm that you would like to exit. Choose OK to discard your changes. Choose Cancel to continue editing.
5.4 Editing Basal Programs (Graph Display)
From the Home Screen, press the Basal Function Button to enter the Basal Screen, then choose the correct Basal Program tab and then rotate the PDA to landscape orientation. This will activate the Basal Program graph display as shown in Figure
36.
Note
Before editing the graph display, please review the functions of the list display to better understand the graph display functions.
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Figure 36
1
Reviewing Basal Programs
The vertical axis of the char t represents the basal rate while the horizontal axis represents the time, which shows 24 hours of the day.
2
Add a Basal Time Period
a) In the graph display, press and hold
on any area of the graph to enter the edit mode as in Figure 37. The highlighted area is the period to be edited.
Figure 37
b) By pressing the buttons, or the
touchscreen, you can choose a different
basal time period.Press to pop up the Basal Rate Setting window as shown in
Figure 34.
c) When finished, press to save and
then to exit the editor mode.
Note
You cannot switch between Basal Programs in Graph Display mode. You must return to List Display to change Basal Program.
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Note
If you have edited a basal program that is currently running on the pump, a dialog box will open asking if you would like to send the updated program to the pump. Choose OK to update and save or Cancel to return to the Basal Edit screen.
5.5 Activating a Basal Program
From the Home Screen, press the Basal Function Button to enter the Basal Screen shown in Figure 31. Select the correct basal program by choosing the correct tab. Press the “Activate <Program Name>” button, and confirm using the dialog box.
Note
After completing the Settings Wizard for the first time, you must start basal deliver y by activating a basal program. Afterward, ac tivating a new basal program will supercede any programs that were previously running.
Note
When a basal program is running, the Activate Program button inside the running program's tab will change from to Temporary Basal Rate (see Chapter
5.6).
5.6 Temporary Basal Rate
Normally, your basal rate does not require frequent changes, but in certain circumstances you may want to temporarily administer a different basal rate to avoid low or high blood sugars.
1
You should consider to decrease your basal rate if your physical activit y decreases on non-work days, if you are eating foods high in protein and fat, if you are experiencing woman’s monthly hormone changes, taking drugs, or have postprandial hyperglycemia.
2
You should consider to increase your basal rate: during strenuous exercise, in periods of rapid weight loss, when in abnormal environmental conditions (such as hot tubs, saunas, etc.), or while drinking alcohol.
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Note
Each person’s physical condition is different. Set your temporary basal rate carefully under your doctor's guidance.
From the Home Screen, press the basal function button to enter the Basal Screen, make sure that the Current Basal Program tab is open, and press the Temporar y Basal Rate button to bring up a temporary basal rate settings dialog box (Figure 38).
Note
The Rate can either be set in U/hr or by % of the current basal rate. For more info about settings, see chapter 5.7
Enter your temporar y basal rate and the amount of time. Press the Begin utton and the PDA will send the command to the pump to administer a temporar y basal rate. When the command is completed, the PDA will automatically return to the Home Screen where the Information Display Area will show the current status of your temporary basal rate (Figure 39).
Figu re 38
Figu re 39
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Note
By default, the Temporary Basal Rate function is off. If the button is greyed out, activate the function using the settings menu (Chapter 5.7)
5.7 Settings
From the Home Screen, choose “Settings – Insulin Delivery Settings” as shown in Figure 40 to change delivery settings.
Figu re 40
Maximum Basal Rate: Used to limit the
1
maximum basal rate that can be set in the Basal Menu
Note
This feature is used to limit the maximum amount of bolus delivery that can be administered by accident or misoperation.
Base Basal Rate: Used to enter the
2
Base Basal Rate (Chapter 5.2)
Note
Setting this value to the most used basal rate will simplify creating Basal Programs.
Temporary Basal Rate: Choose to
3
adjust settings for temporary basal rates.
a) Off: Turn off the Temporary Basal Rate
function. The corresponding Temporary Basal Rate button will be greyed out.
b) U/hr: Temporar y Basal Rate will be
displayed in U/hr.
c) %: Temporary Basal Rate will be
displayed as a % of the current basal rate.
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6 Boluses
6.1 Understanding Boluses
Diabetics have elevated blood sugar levels after meals, requiring bolus doses of insulin to lower blood sugar levels. A bolus refers to the amount of insulin that is quickly infused before a meal.
Carbohydrates, proteins, and fats all affect your blood glucose level differently (Fig. 41). There are two types of boluses that can be administered to handle different types of food intake.
Blood Sugar
Carbohydrate
Protein
Fat
Time
Figu re 41
6.2 Manual Boluses
Manual boluses are used to offset high
blood glucose levels.
From the Home Screen, choose the Bolus button to enter the Bolus Screen (Figure 42) .
Figu re 42
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Choose the Bolus button in the upper
left corner to open the dialog box (Figure
43). Choose your bolus size and press OK.
Figu re 43
If the Bolus amount is not 0, the Start button will be green, and you can choose the Start button to begin to administer the bolus. A confirmation window will open to confirm the amount, choose OK to confirm and the PDA will send a command to the pump to start delivery.
While the pump is delivering, the PDA will rever t to the Home Screen and display the bolus status (Figure 44).
Figu re 44
6.3 Bolus Presets
The Bolus Screen contains three
programmable preset boluses (Figure 45).
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3 Bolus Presets
Figu re 45
You can set up each of the three preset boluses (they are empty by default).
Add Preset: If a preset is empty, you
1
may press any where on the button to open the Preset dialog box (Figure 46). Edit the parameters to create a new Preset.
Figu re 46
Using a Preset:If a Preset is already
2
programmed, press the lef t area of the button and the value will appear in the bolus amount to the far left. A small arrow will appear that links the preset that has been chosen to the bolus amount (Figure
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47). You can administer the bolus now by pressing the Start button as in Section
Figu re 47
Edit Preset:Press the icon to open
3
the Preset settings dialog box. Change the settings, and press OK to save.
6.2.
Note
All three presets can be administered in any order, but only one can be administered at a time.
6.4 Extended Boluses
6.4.1 Extended Bolus with Amount Now
An Extended Bolus with Amount Now can be useful when you eat meals with both rapidly and slowly absorbed carbohydrates such as some fast foods. An Extended Bolus With Amount Now is a bolus that is administered in two stages – an amount immediately, and the remainder over an extended period of time.
Note
This feature requires a detailed understanding one’s carbohydrate absorption rate. Please consult with your professional healthcare provider before using this feature.
From the Home Screen, choose the
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Bolus button to enter the Bolus Screen and then enter a bolus amount (Section 6.2). Press Extend Bolus to open the Extend Bolus window (Figure 48).
Note
By default, the Extend Bolus function is off. If the button is greyed out, be sure to activate the function using the settings menu (Section 6.7).
Figu re 48
Amount N ow: the bolus amo unt to be
administered immediately
Exte nd amount = Total Bolu s – Amount Now
Exte nd Time: The time p eriod over whic h the exten ded amount will be admin istered.
Note
The Amount Now can be set in absolute units (U) or relative to the total bolus amount (%). See Section 6.7 to change this setting.
Press OK to accept this setting and go back to the Bolus Screen. The Bolus Screen will now display the Amount Now and Extend Time (Figure 49).
Figu re 49
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Choose the Start button to begin to administer the bolus. A confirmation window will open to confirm the amount, choose OK to confirm and the PDA will send a command to the pump to start deliver y. While the pump is delivering, the PDA will revert to the Home Screen and display the bolus status (Figure 50).
Figu re 50
6.4.2 Extended Bolus Without Amount Now
An Extended Bolus Without Amount Now can be useful when you have eaten a long meal with extended snacking, have delayed digestion due to gastroparesis or for meals high in fat. The Extended Bolus Without Amount Now can be administered over a time period of 30 minutes and 8 hours.
Before using this feature, please read section 6.4.1. To administer an Extended Bolus Without Amount Now, set the Amount Now to 0 (zero). No immediate bolus will be administered, and the total bolus amount will be administered over the time period specified.
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6.5 Quick Bolus
The Equil patch insulin pump system has a Quick Bolus feature that allows the user to administer a bolus without using the touchscreen or looking at the PDA Display. This feature can be handy if you forget your PDA, or would like to administer a bolus discretely.
Note
By default, the Quick Bolus function is off. To enable, be sure to activate the function using the settings menu (Section 6.7)
6.5.1 Quick Bolus Using the PDA
While in the Lock Screen, press and
1
hold the Enter (Select) button for about 3 seconds. The PDA will give an audible alert and enter the Quick Bolus screen (Figure
51).
Figu re 51
The next time you press the Enter
2
(Select) button the bolus size will increase by a predetermined increment. This increment can be set in the settings menu (Section 6.7). Also, every time you press the Enter (Select) button, you will hear
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a beep from the PDA to confirm that you have pressed the button. Each time you press the button, the tone will ascend in pitch (up to 5, and then repeating) to help you remember the number of times you have pressed the button.
Note
The maximum number of increments for a quick bolus is 20.
Note
If there is no activity for 10 seconds, the PDA will revert to the Lock Screen.
After you have set the correct bolus
3
amount by pressing the Enter (Select) button the appropriate amount of times, wait for 3 seconds and the PDA will repeat the audible tones back for you to confirm the correct number of bolus increments. If the number of tones is correct, press the Enter (Select) button one last time, and the bolus will be administered.
Note
If you would like to cancel, simply press the Back button or wait 10 seconds for the system to rever t to the lock screen
When the pump receives the bolus correctly, you will hear a confirmation tone and the bolus will start. The PDA will automatically return to the main screen, displaying the bolus and time remaining.
6.5.2 Quick Bolus Using the Pump
Administering a Quick Bolus on the pump is similar to administering a Quick Bolus on the PDA.
Press and hold the Bolus button on the
1
patch pump. The pump will give an audible alert which indicates that you can enter a quick bolus amount.
With each subsequent button press, the
2
bolus size will increase by a predetermined increment. This increment can be set
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in the settings menu (Section 6.7). Also, every time you press the Enter (Select) button, you will hear a beep from the pump to conf irm that you have pressed the button. Each time you press the button, the tone will ascend in pitch (up to 5, and then repeating) to help you remember the number of times you have pressed the button.
Note
The maximum number of increments
for a Quick Bolus is 20.
Note
If there is no activity for 10 seconds,
the pump exits the Quick Bolus mode.
After you have set the correct bolus
3
amount, wait for 3 seconds and the pump will repeat the audible tones back for you to confirm the correct number of bolus increments. If the number of tones is correct, press the pump button one last time, and the bolus will be administered.
Note
If you would like to cancel, simply wait 10 seconds for the system to exit the Quick Bolus mode.
6.6 Canceling a Bolus
A bolus can be stopped during delivery. This can be helpful, for example, if you notice that the bolus size is incorrect, or if your meal plans change.
When the bolus is being administered, the Home Screen is displayed and bolus information is shown in the Information Display Area.
Press the Cancel button and a confirmation window will appear. Press OK to confirm. You can also cancel a bolus by pressing and holding the Quick Bolus button on the pump.
Note
Cancelling a bolus deliver y will cancel the total bolus (Amount Now and Extended amount).
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6.7 Settings
From the Home Screen, the Bolus settings can be found at "Settings - Bolus Settings" as shown in Figure 52.
Figu re 52
Bolus Rate: The normal bolus delivery
1
rate is 3.0U/min. Use this menu to decrease the bolus rate to 1.5U/min.
Bolus Increment Setting: This is the
2
amount that the requested bolus changes when pressing the "+" or "-" button.
Maximum Bolus Setting: This is the
3
maximum bolus that the user can choose in the bolus menu.
Note
This feature is used to reduce the possibility of overdosage caused by mistake. Try to set this value as the maximum bolus that you would normally give. Set ting this value too high increase the risk of overdosage by misoperation.
Extended Bolus Settings:
4
a) OFF: Extended bolus function is off,
and corresponding button will be greyed out (default)
b) U: The Amount Now will be displayed
in Units of insulin (U).
c) %: The Amount Now will be displayed
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as a % of the total bolus amount.
Quick Bolus Settings: Check the
5
checkbox next to Quick Bolus to enable the Quick Bolus function. Additional Quick Bolus settings will be activated.
a) Quick Bolus Increment: Sets the
amount that the bolus increases with ever y Quick Bolus button press.
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7 Therapy Setup
7.1 Infusion Set Setup
First wash your hands and the infusion
1
site and let everything dr y. Remove the pump base from its packaging and place it on one of the suggested areas shown in Fig. 53 (abdomen, upper arm, thigh, lower back, etc.) Avoid sites that may rub against other objects like belts, waistbands or tight clothing. Also make sure that your infusion site is at least 2-3cm away from your navel. Do not use the abdomen if you are late in pregnancy.
Open the cannula pack as indicated on
2
the packaging. Push the cannula assembly into the cannula inserter as shown in Figure 54 until the cannula assembly is in the cocked position and you hear a click. You should see that the cannula assembly is connected firmly to the cannula inserter and the inserter is held firmly in the cocked position.
Note
Infusion sets are comprised of a cannula pack and base. Be sure to use only infusion accessories from MicroTech such as HRN-S-60, HRN-S-90, HRN-H-45, or HRN-H-65.
Front
Figure 53
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Back
Figu re 54
Page 54
Remove the protective sleeve as shown
3
in Figure 55.
Figure 55
Warning
!
Exercise caution when the needle is
exposed !
Place the inserter onto the pump base
4
as shown in Figure 56. Use the triangle on the inserter to orient it correctly in relation to the pump base. Push the two snaps into the pump base until it securely held together. Press the two white buttons toward each other and the cannula will be inserted into the base and infusion site.
Figu re 56
Release the inserter from the pump
5
base by pushing the two hooks toward each other as shown in Figure 57. If the inserted needle or needle base remains on the cannula, carefully remove it from the infusion site. Place the protective sleeve back onto the cannula assembly.
Cannula
Figu re 57
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If the needle remains in the inserter,
6
place the protective sleeve back onto the needle hub. Firmly push the top of the inserter to eject the needle hub (Figure 58) and dispose of properly.
Figu re 58
Note
Dispose of the insertion needle
properly in a medical sharps container.
7.2 Removing the Infusion Set
Peel up one end of the tape as shown in Figure 59 and continue to peel away from the skin until the entire infusion set has been removed.
Figu re 59
7.3 Filling the Reservoir
Remove the new reservoir from the
1
packaging.
Use an alcohol wipe to clean the insulin
2
vial and then attach it to the fill adapter as in Figure 60.
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Figu re 60
With the insulin vial on top, slowly
3
pull the pullrod and draw insulin into the reservoir as in Figure 61.
Figu re 61
Tap the side of the reservoir to
4
encourage any air bubbles to rise to the top of the reservoir (Figure 62).
Figu re 62
Push the pullrod slowly to ejec t the
5
bubbles back into the vial, and then slowly pull to draw more insulin into the reservoir. Repeat until the reservoir has enough insulin and there are no air bubbles (Figure
63).
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Figu re 63
Remove the insulin vial from the f ill
6
adapter (Figure 64).
Figu re 64
Pull the two release tabs (shown in
7
Figure 65) away from the reservoir to release the fill adapter.
Note
The fill adapter contains a needle,
please dispose of properly.
Figu re 65
Remove the pullrod by unscrewing it
8
counterclockwise (Figure 66)
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图
65
Figu re 66
7.4 Assembling Reservoir to Pump
Figure 77 illustrates the sequence to attach the reser voir and battery to the pump. Always install a fully charged batter y with a newly filled reser voir.
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Figu re 67
Be sure that the battery is inserted in the orientation shown in Figure 67.
Figu re 68
7.5
Disassembling the Reservoir
Holding the pump and reservoir in the orientation shown in Figure 69, bend the assembly along the seam line as shown until the reservoir separates from the pump. Be sure to recharge the battery
immediately to make sure that a fresh batter y is always installed with a new reservoir. Dispose of the used reservoir in a medical sharps container.
Note
Pay close attention to the orientation of the pump during disassembly. Incorrect disassembly may cause damage.
Figu re 69
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8 Replacing the Patch Pump
Warning
!
Before continuing, please make sure you are familiar with frequently used pump setup operations such as installing/removing an infusion set, filling a new reservoir, and assembling/ disassembling the reservoir (Chapter 7).
This section explains how to connect a new patch pump to the PDA or replace an old one.
From the Home Screen, choose the
1
Actions button and then the New Pump button to enter the New Pump Wizard
a) If this is your first time using the wizard
to connect your pump, the wizard will start with Figure 70. Apply a new infusion set(Chapter 7.3), Assemble a filled reservoir and a charged bat tery to the pump as shown in the animation (Figure
73). Press Continue to go to the next page.
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