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UM1 | Users Manual | 3.90 MiB | July 16 2019 | |||
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1 | External Photos | July 16 2019 | ||||||
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1 | Cover Letter(s) | July 16 2019 | ||||||
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1 | ID Label/Location Info | July 16 2019 | ||||||
1 | OP | Operational Description | July 16 2019 | confidential | ||||
1 | RF Exposure Info | July 16 2019 | ||||||
1 | SCH | Schematics | July 16 2019 | confidential | ||||
1 | Test Setup Photos | July 16 2019 | ||||||
1 | block diagram | Block Diagram | July 16 2019 | confidential | ||||
1 | operation | Operational Description | July 16 2019 | confidential | ||||
1 | Test Report | July 16 2019 |
1 | UM1 | Users Manual | 3.90 MiB | July 16 2019 |
Patch Insulin Pump System MTM-I Patch Insulin Pump System Instruction Manual Table of Contents 1 Foreward 2 Brief Introduction 2.1 Indications 2.2 Patients 2.3 Contraindications 2.4 Before Use 2.5 How to Use This Guide 2.6 Getting Help 2.7 Prepare for Emergencies 2.8 Insulin Pump Precautions 2.9 Portable Diabetes Assistant
(PDA) Precautions 2.10 Blood Glucose Test Module 1 1 1 1 2 2 3 3 4 4 5 Precautions 5 2.11 Important Safety Information 6 3 Component Descriptions 3.1 Pump System Components 3.2 Accessories 8 8 8 4 Getting Started 4.1 PDA Setup 11 11 4.2 Charging the Batteries 4.3 Settings Wizard 4.4 Home Screen 4.5 Lock Screen 15 17 24 27 29 5 Basal Rate Adjustment 29 5.1 Understanding Basal Rate 5.2 Base Basal Rate 29 5.3 Editing Basal Programs (List Display 29 5.4 Editing Basal Programs (Graph Display33 5.5 Activating a Basal Program 34 35 5.6 Temporary Basal Rate 5.7 Settings 36 6 Boluses 6.1 Understanding Boluses 6.2 Manual Boluses 6.3 Bolus Presets 6.4 Extended Boluses 6.5 Quick Bolus 6.6 Canceling a Bolus 6.7 Settings 38 38 38 39 41 44 46 47 49 7 Therapy Setup 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 64 9.1 Setup 10 The Built-in Blood Glucose Meter 70 70 70 70 73 75 75 10.1 Operating Principle 10.2 Application 10.3 Blood Sampling 10.4 Lancet Removal 10.5 Ejecting Test Strips 10.6 Testing Blood Glucose 10.7 Comparing Meter and Lab Results 10.8 Quality Control Tests 10.9 Entering Your Glucose 77 78 Reading Manually 81 82 10.10 Settings 10.11 Blood Glucose Meter Troubleshotting 84 85 11 Bolus Calculator 85 11.1 Introduction 11.2 Using the Bolus Calculator 86 11.3 Settings 89 12 History 12.1 Viewing Your History 12.2 Historical Averages 13 General Settings 13.1 Time and Date 13.2 About the System 13.3 Language 13.4 Memory Card 13.5 Display 13.6 User Settings 13.7 Bluetooth 91 91 93 95 95 95 96 96 96 97 97 14 Additional Features 100 17.12 Other Considerations 18 Specifications 18.1 General Specifications 18.2 Delivery 18.3 Blood Glucose Meter 18.4 Bolus Calculator 18.5 Bolus Delivery 18.6 Infusion Precision 18.7 Occlusion Detection 114 115 115 116 116 117 117 117
(Maximum Infusion Pressure) 118 118 118 18.8 Occlusion Alarm Time 18.9 Overdose/Underdose 18.10 Electromagnetic Compatibility 19 Appendix 19.1 Symbols 119 124 124 14.1 Audio Player 14.2 Auto-Off 14.3 Food Database 100 100 100 15 Suspend/Resume 101 15.1 How to Suspend/Resume 101 16 Alarms and Troubleshooting 103 16.1 Patch Pump Alarms 105 106 16.2 PDA Alarms 16.3 Alarm System Delay 107 108 17 Maintenance 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 112 112 17.8 Precautions 113 17.9 Disposal 113 17.10 Transportation 17.11 Storage 113 1 Foreward 2 Introduction 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. 2.1 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:
1 Hematocrit range of 30% to 55%. 2 Triglyceride concentration does not exceed 3,000 mg/dL or cholesterol 1 Equil Patch Insulin Pump System concentration does not exceed 500 mg/dL. 3 Non-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. 1 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. 2 Active Insulin Time The length of time that insulin 2 Equil Patch Insulin Pump System 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 patients 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. 5 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. 3 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. 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/doctors 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 4 Equil Patch Insulin Pump System 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:
5 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 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 doctors 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 6 Equil Patch Insulin Pump System 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. 7 Equil Patch Insulin Pump System 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:
1This device may not cause harmful interference, and 2this device must accept any interference received, including interference that may cause undesired operation. 3 Component Descriptions Patch Pump 3.1 Pump System Components Portable Diabetes Assistant (PDA) Battery Contacts Bolus Button Motor System 3.2 Accessories 1 Cannula Inserter 8 Equil Patch Insulin Pump System 2 Pump Battery 4 PDA Charger 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. PDA Charging Cable 5 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. 9 Equil Patch Insulin Pump System 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 Patch PumpMTM-1 Portable Diabetes Assistant (PDA):
MTM-2 Cannula Inserter Pump Battery Pump Battery Charger PDA Charger PDA Charging Cable 10 Equil Patch Insulin Pump System 4 Getting Started 2 Insert a microSD memory card:
Insert memory into the slot as shown in Figure 5. 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. Figure 5 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. 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. Finger Hold Figure 4 11 Equil Patch Insulin Pump System 3 Insert the Battery: Install the battery in the orientation shown in Figure 6. 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. Figure 6 Note Figure 7 Use only batteries and chargers from MicroTech Medical. Use of third party accessories may cause unexpected behaviour and will void your warranty. 5 The PDA controls are shown in Figure 8 12 Equil Patch Insulin Pump System 1 10 11 1 Power Button Power OnPress 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. Note The PDA display will also turn off and enter standby mode after a preset time. See Section 13.6 for more information. 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 2 If you need help with commands or functions of the PDA, you can press the 9 7 8 12 13 2 3 4 Figure 8 5 6 13 Equil Patch Insulin Pump System 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. Up Button 5 This can be used to navigate the interface without using the touchscreen. Choose up to change selection. Down Button 6 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. Display Charger/Data Port 8 3.2 inch color display with touchscreen. 9 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 10 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. 14 Equil Patch Insulin Pump System 11 3.5mm Headphone Jack Test Strip Ejector 12 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. 4.2.1 PDA Charger 1 The 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. 15 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 9. Figure 9 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 off, a charging animation will appear. Equil Patch Insulin Pump System 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 1 The 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 2 Insert 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 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 flash if the charger is faulty. 4 When the battery is fully charged, the blue LED will turn off and you can disassemble the cable, pump battery charger, and PDA charger. 16 Equil Patch Insulin Pump System 5 Remove the pump battery as shown 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. Figure 12 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. 17 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. 1 Time and Date Settings After entering the Settings Wizard, you will be presented with the Time and Date setup screen shown in Figure 13. Equil Patch Insulin Pump System Figure 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 select the date, choose OK to save and exit or Cancel to exit without saving. Figure 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. Figure 15 18 Equil Patch Insulin Pump System Note If the 12 hour format is chosen, am and pm will be shown. Figure 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 12-
hour format. 2 Basic Basal Settings The second screen in the Settings Wizard shows the basic basal settings
(Figure 17). 19 Note Figure 17 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 Equil Patch Insulin Pump System the appropriate maximum rate. Choose OK to save and exit or Cancel to exit without saving. Figure 18 Note 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. Figure 19 Note 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. 20 Equil Patch Insulin Pump System%: Temporary basal rates will be displayed relative to your current basal rate. Figure 20 After you have finished choosing the Basic Basal settings, choose Next to enter the third Settings Wizard screen, or Previous to enter the previous setting screen. 3 Basic Bolus Settings The third screen in the Settings Wizard shows the Basic Bolus settings (Figure 21). 21 Figure 21 Note For a more detailed description of boluses, see Section 6.1 a) The Bolus Increment setting (Figure 22) allows you to set the interval used when increasing or decreasing bolus amounts. Equil Patch Insulin Pump System 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. Figure 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. Figure 23 Figure 24 22 Equil Patch Insulin Pump System After you have finished choosing the Basic Bolus settings, choose Next 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). Figure 25 23 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 fifth Settings Wizard screen, or Previous to enter the previous setting screen. 5 Alert Options The fifth screen in the Settings Wizard shows the Alert Options (Figure 26). If you Equil Patch Insulin Pump System choose the Low Reservoir 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. Figure 26 After you have completed the Settings Wizard, choose Finish to finalize your settings and return to the Home Screen. To continue modifying settings 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. 24 Equil Patch Insulin Pump System Status Bar Information Display Area 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:
Alert icon: If an alert appears, this UsernameDisplays the name of the user. Insulin Pump Serial Number: Displays the serial number of the pump that is currently connected icon will appear on the status bar. Insulin RemainingShows how much insulin remains by varying degreeif PDA wireless link is poor it displays ?
Pump Battery LevelShows the pump's battery level status in varying degrees; if PDA wireless link is poor, it displays ?
Shows the wireless link strength between pump and PDA. It dispalys connection is totally lost.
(BG Reminder)This icon will appear on the status bar if a Test Reminder has been programmed. Blood Glucose Test Reminder Wireless Link Status
! when the Function Buttons Figure 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 25 Equil Patch Insulin Pump System PDA Battery LevelShows the PDA's battery level status in varying 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. Figure 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 actions are completed. Function Buttons 1 Bolus: Pressing this button takes you to the Bolus Screen where you can administer a normal or extended bolus. 2 Basal: Pressing this button takes you to the Basal Screen where you can adjust your basal programs or start a temporary 26 Equil Patch Insulin Pump System basal rate. 3 Actions: Pressing this button takes you to the Actions Screen where you can start a new reservoir, initiate a new pump, manually enter your blood glucose level, access the food library, or access the music player. 4 HistoryTakes you to therapy history and historical averages. 5 SettingsPress this to go to the Settings Menu. 6 Suspend/Resume: Pressing this button 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 27 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 Equil Patch Insulin Pump System 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 year. 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. 28 Equil Patch Insulin Pump System 5 Basal Rate Adjustment 5.1 Understanding Basal Rate Basal insulin is the pumps 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 pumps 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 sections you will learn to edit a basal program by modifying the base basal rate in different time periods. 29 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 Basal Program Action Buttons Figure 30 Equil Patch Insulin Pump System 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. 2 Reviewing Basal Programs 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. 3 Quick Basal Program Setup 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 further 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. 30 Equil Patch Insulin Pump System screen as shown in Figure 32. Figure 32 Figure 31 Editing Basal Programs 4 a) Add new basal rateThe 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 31 Equil Patch Insulin Pump System 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 Figure 34 icon. b) Editing a basal time period: You can edit a basal time period entry by pressing the c)Deleting a basal time period: You can delete a basal time period entry by pressing the revert to the base basal rate. icon. The time period will 32 Equil Patch Insulin Pump System Note After deleting a basal time period, the PDA may merge adjacent basal time periods if the basal rates are the same. 5 Name Changing the Basal Program Press the Change Basal Program Name button to open the Change Name dialog box (Fig 35). Change to the desired name . Figure 35 6 Saving Settings 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. 33 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. Equil Patch Insulin Pump System Figure 36 Figure 37 1 Reviewing Basal Programs The vertical axis of the chart represents Add a Basal Time Period the basal rate while the horizontal axis represents the time, which shows 24 hours of the day. 2 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. buttons, or the b) By pressing 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 then to exit the editor mode. to save and Note You cannot switch between Basal Programs in Graph Display mode. You must return to List Display to change Basal Program. 34 Equil Patch Insulin Pump System 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 delivery by activating a basal program. Afterward, activating a new basal program will supercede any programs that were previously running. 35 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 activity decreases on non-work days, if you are eating foods high in protein and fat, if you are experiencing womans 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. Equil Patch Insulin Pump System Note Each persons 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 Temporary 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 temporary basal rate and the amount of time. Press the Begin utton and the PDA will send the command to the pump to administer a temporary 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). Figure 38 Figure 39 36 Equil Patch Insulin Pump System 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. Figure 40 37 1 Maximum Basal Rate: Used to limit the 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. 2 Base Basal Rate: Used to enter the Base Basal Rate (Chapter 5.2) Note Setting this value to the most used basal rate will simplify creating Basal Programs. 3 Temporary Basal Rate: Choose to 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: Temporary Basal Rate will be displayed in U/hr. c) %: Temporary Basal Rate will be displayed as a % of the current basal rate. Equil Patch Insulin Pump System 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 Time Figure 41 Fat 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) . Figure 42 38 Equil Patch Insulin Pump System Choose the Bolus button in the upper left corner to open the dialog box (Figure 43). Choose your bolus size and press OK. Figure 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 revert to the Home Screen and display the bolus status (Figure 44). 39 Figure 44 6.3 Bolus Presets The Bolus Screen contains three programmable preset boluses (Figure 45). Equil Patch Insulin Pump System 3 Bolus Presets 1 Add Preset: If a preset is empty, you may press anywhere on the button to open the Preset dialog box (Figure 46). Edit the parameters to create a new Preset. Figure 45 You can set up each of the three preset boluses (they are empty by default). Figure 46 2 Using a PresetIf a Preset is already programmed, press the left 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 40 Equil Patch Insulin Pump System 47). You can administer the bolus now by pressing the Start button as in Section 6.2. Figure 47 3 Edit PresetPress the the Preset settings dialog box. Change the settings, and press OK to save. icon to open 41 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 ones carbohydrate absorption rate. Please consult with your professional healthcare provider before using this feature. From the Home Screen, choose the Equil Patch Insulin Pump System 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). 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). Figure 48 Amount Now: the bolus amount to be administered immediately Extend amount = Total Bolus Amount Now Extend Time: The time period over which the extended amount will be administered. Figure 49 42 Equil Patch Insulin Pump System 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 revert to the Home Screen and display the bolus status (Figure 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. Figure 50 43 Equil Patch Insulin Pump System 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 1 While in the Lock Screen, press and hold the Enter (Select) button for about 3 seconds. The PDA will give an audible alert and enter the Quick Bolus screen (Figure 51). Figure 51 2 The next time you press the Enter
(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 44 Equil Patch Insulin Pump System 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. 3 After you have set the correct bolus 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. 45 Note If you would like to cancel, simply press the Back button or wait 10 seconds for the system to revert 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. 1 Press and hold the Bolus button on the patch pump. The pump will give an audible alert which indicates that you can enter a quick bolus amount. 2 With each subsequent button press, the bolus size will increase by a predetermined increment. This increment can be set Equil Patch Insulin Pump System 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 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 pump exits the Quick Bolus mode. 3 After you have set the correct bolus 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 delivery will cancel the total bolus (Amount Now and Extended amount). 46 Equil Patch Insulin Pump System 6.7 Settings From the Home Screen, the Bolus settings can be found at "Settings - Bolus Settings" as shown in Figure 52. Figure 52 47 1 Bolus Rate: The normal bolus delivery rate is 3.0U/min. Use this menu to decrease the bolus rate to 1.5U/min. 2 Bolus Increment Setting: This is the amount that the requested bolus changes when pressing the "+" or "-" button. 3 Maximum Bolus Setting: This is the 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. Setting this value too high increase the risk of overdosage by misoperation. 4 Extended Bolus Settings:
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 Equil Patch Insulin Pump System as a % of the total bolus amount. 5 Quick Bolus Settings: Check the 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 every Quick Bolus button press. 48 Equil Patch Insulin Pump System 7 Therapy Setup 7.1 Infusion Set Setup 1 First wash your hands and the infusion site and let everything dry. 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. 2 Open the cannula pack as indicated on 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 Back Figure 53 Figure 54 49 Equil Patch Insulin Pump System 3 Remove the protective sleeve as shown in Figure 55. Figure 55 Warning Exercise caution when the needle is exposed 4 Place the inserter onto the pump base 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. Figure 56 5 Release the inserter from the pump 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. Figure 57 Cannula 50 Equil Patch Insulin Pump System 6 If the needle remains in the inserter, 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. 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. Figure 59 7.3 Filling the Reservoir 1 Remove the new reservoir from the packaging. 2 Use an alcohol wipe to clean the insulin vial and then attach it to the fill adapter as in Figure 60. Figure 58 Note Dispose of the insertion needle properly in a medical sharps container. 51 Equil Patch Insulin Pump System 4 Tap the side of the reservoir to encourage any air bubbles to rise to the top of the reservoir (Figure 62). Figure 60 3 With the insulin vial on top, slowly pull the pullrod and draw insulin into the reservoir as in Figure 61. Figure 62 5 Push the pullrod slowly to eject the 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). 52 Figure 61 Equil Patch Insulin Pump System 7 Pull the two release tabs (shown in Figure 65) away from the reservoir to release the fill adapter. Note The fill adapter contains a needle, please dispose of properly. Figure 65 8 Remove the pullrod by unscrewing it counterclockwise (Figure 66) Figure 63 6 Remove the insulin vial from the fill adapter (Figure 64). Figure 64 53 Equil Patch Insulin Pump System 65 Figure 66 7.4 Assembling Reservoir to Pump Figure 77 illustrates the sequence to attach the reservoir and battery to the pump. Always install a fully charged battery with a newly filled reservoir. 54 Equil Patch Insulin Pump System immediately to make sure that a fresh battery 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. Figure 69 Figure 67 Be sure that the battery is inserted in the orientation shown in Figure 67. Figure 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 55 Equil Patch Insulin Pump System 8 Replacing the Patch Pump 73). Press Continue to go to the next page. 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. 1 From the Home Screen, choose the 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 battery to the pump as shown in the animation (Figure 56 Equil Patch Insulin Pump System
1 | UM2 | Users Manual | 3.92 MiB | July 16 2019 |
Figure 70 b) If this is not your first time using the wizard to connect a pump, the wizard will start with Figure 71. Remove the pump and reservoir from the infusion set as shown in Figure 72. Remove the old infusion set, apply a new one (Chapter 7.3) and press Continue. The next page will prompt you to 57 Equil Patch Insulin Pump System disconnect your old pump. Press Continue to disconnect the old pump from the PDA and wait for the pump to rewind. Separate the used reservoir from the pump (Chapter 7.5), dispose of the old reservoir, and then assemble a filled reservoir and a charged battery to the pump as shown in the animation (Figure 70). Press Continue to go to the next page. Note Be sure to use a fully charged battery. A low battery may require you to change reservoirs more frequently, resulting in wasted insulin. 58 Equil Patch Insulin Pump System Figure 72 Note For safety reasons, the PDA can only control one pump at a time. 2 Enter the New Pump Serial Number in the space provided (Figure 73) using the onscreen keyboard. Press the Back button to exit the keyboard and press Continue. The PDA will attempt to connect Figure 71 59 Equil Patch Insulin Pump System to the new pump. After the new pump has been activated, the PDA will show a confirmation screen (Figure 74). 3 From the confirmation screen (Figure 74), press the Continue button. MTM-I
!
XXXXXX IPX4 Figure 73 Serial Number Figure 74 4 Holding the pump in the orientation shown in Figure 76, press the Prime Reservoir button (Figure 75). The plunger will begin to move slowly. Continue to press the button until you see a drop of insulin on the needle tip (Figure 76). Now press Continue. 60 Equil Patch Insulin Pump System 5 Connect the pump to the infusion set as shown in Figure 77 and press Continue. Figure 75 Needle Tip Figure 76 61 Equil Patch Insulin Pump System Figure 77 6 Now choose whether or not to prime the cannula (Figure 78). Upon completion, the pump will begin to deliver. Note Skip only if the infusion set was not replaced (and thus the cannula doesn't need to be filled). 62 Equil Patch Insulin Pump System Figure 78 63 Equil Patch Insulin Pump System 9 Replacing the Reservoir you should to remove and replace the infusion set (Chapters 7.1-7.2) and prepare a new insulin reservoir (Chapter 7.3). 9.1 Setup 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). If the insulin reservoir connected to your pump becomes empty, you should replace the reservoir. 1 From the Home Screen, choose the Actions button and then the New Reservoir button to enter the New Reservoir Wizard. Remove the pump and reservoir from the infusion set as shown in Figure 78. Press Continue, the pump will rewind, and the PDA will display the next page of the wizard. Before proceeding to the next step, 64 Equil Patch Insulin Pump System Figure 79 2 Separate the used reservoir from the pump (Chapter 7.5), dispose of the old reservoir, and then assemble a filled reservoir and a charged battery to the pump as shown in the animation (Fig. 80). Press Continue to go to the next page. Note Be sure to use a fully charged battery. A low battery may require you to change reservoirs more frequently, resulting in wasted insulin. 65 Equil Patch Insulin Pump System 66 Equil Patch Insulin Pump System Figure 80 3 Holding the pump in the orientation shown in Figure 82, press the Prime Reservoir button (Figure 81). The plunger will begin to move slowly. Continue to press the button until you see a drop of insulin on the needle tip (Figure 81. Press Continue to go to the next step. 67 81 Needle Tip Figure 82 Equil Patch Insulin Pump System 4 Connect the pump to the infusion set as shown in Figure 83 and press Continue. 68 Equil Patch Insulin Pump System Figure 84 Figure 83 5 Now choose whether or not to prime the cannula (Figure 84). Upon completion, the pump will begin to deliver. Note Skip only if the infusion set was not replaced (and thus cannula doesn't need to be filled). 69 Equil Patch Insulin Pump System 10 The Built-in Blood Glucose Meter 10.1 Operating Principle The integrated blood glucose test meter uses an electrochemical biosensor containing glucose oxidase and detects
-d glucose in a blood sample. When the blood sample touches the edge of the test strip, the strip automatically absorbs it and reacts with the chemical reagent in the reaction area. The chemical reaction causes a change in current, which is measured to yield the glucose concentration. 10.2 Application It is used to determine blood glucose concentrations in whole fresh capillary blood. It can be used for both self-testing and professional use. Test results can be used to manage blood sugar levels, but should be used for the diagnosis of diabetes. 10.3 Blood Sampling Before testing, become familiar with how to collect blood and choose a clean and dry place to conduct the test. Important Tips Prior to testing, use with either alcohol or soapy water to disinfect the sampling site. Use warm water to increase blood flow if necessary. Dry your hands and the sampling site, ensuring that there is no soap residue remaining. Lancet Safety Cap Lancet Holder Cocking Barrel Release Button Figure 85 70 Equil Patch Insulin Pump System 2 Twist off the safety cap from the lancet, save the safety cap for lancet disposal. 10.3.1 Fingertip Testing Adjust the penetration depth to reduce the discomfort. You do not need the clear cap for fingertip sampling. 1 Remove the lancing device cap. Insert the lancet into the lancet holder until it comes to a complete stop. 5 4 Figure 87 3 Carefully install the lancing device cap onto the lancing device, avoid touching the lancet needle tip. 5 4 Figure 86 Figure 88 71 Equil Patch Insulin Pump System 4 Adjust the puncture depth by rotating the depth adjustor (the lancing device has 5 puncture depth settings). To reduce discomfort, choose the lowest setting that still produces an adequate blood sample. Depth Adjustment 1 and 2: for delicate skin 3: for normal skin 4 and 5: for thick or calloused skin Note Greater pressure between the lancing device against the finger will also increase the puncture depth. 5 Pull back the cocking barrel until you hear a click. Now the lancing device is loaded and ready to draw blood. 5 4 Figure 90 6 Before taking a blood sample, wash your hands or use an alcohol swab to clean the area. Washing your hands in hot water increases blood circulation. You can also massage from wrist to finger to promote better blood circulation. 4 3 2 Figure 89 72 Equil Patch Insulin Pump System Figure 91 7 Holding the lancing device against the side of the finger to be lanced, press the release button and then put down the lancing device. Massage forward slowly from the base of your finger to the tip to increase the sample size. Figure 92 Note To reduce pain, lance on the sides of the fingertips, where there are less nerve endings. Rotate finger locations as much as possible to accelerate wound healing and decrease callouses. 4 3 2 10.4 Lancet Removal 1 Unscrew the lancing device cap. Firmly push the needle into the safety cap. 73 Equil Patch Insulin Pump System Figure 93 2 Pull out the lancet from the lancet holder. Please dispose of the used lancet properly. Figure 94 Lancet Precautions:
Do not use a lancet if the safety cap is loose or missing. Do not use a lancet if the needle is bent. Use caution whenever a lancet needle is exposed. Do not share lancets with other people. To avoid cross contamination, always use a new sterilized lancet. Do not reuse lancets. Avoid contaminating lancets with hand lotion, detergents, oil, and other debris. Reminder Lancing devices and lancets should not be shared. Each person should have his own lancing device and lancets. Clean your lancing device before and after use with alcohol or a disinfectant wipe. Be sure to clean the part of the device that touches the finger. Do not immerse the lancing device in water. Control excess bleeding and disinfect your wound after use. 74 Equil Patch Insulin Pump System 10.5 Ejecting Test Strips 10.6 Testing Blood Glucose The back side of the PDA contains a test strip ejector. You can easily eject the test strip by sliding the ejector button as shown in Figure 95. If the display is on, insert an Exactive EQ test strip and the blood glucose meter screen will appear (Figure 96). Figure 95 75 Figure 96 After the strip has been inserted, apply blood as shown on the screen. When Equil Patch Insulin Pump System enough blood has been applied, the screen will count down 5 seconds and then display the test result as in Figure 97. Test Result Area Figure 97 User Actions 1 Test Result AreaDisplays the blood glucose test result with the correct unit and time/date. The scale above the reading shows whether or not the result falls within the target range. If the result is outside of the range, the bar will be yellow. 2 User Actions Area: Contains blood glucose result tags, invalid measurement selection and Bolus Calculator button. Result Tags: Use this area to tag your results before/after exercise, or before/after meal. These tags will help sort your results into different categories when calculating averages. Invalid Measurement Box: if checked, the measurement will be recorded in history, but will not be used to calculate averages. Bolus Calculator: If the Bolus Calculator is enabled in the Settings Menu, the button turn green after a blood glucose reading has been recorded. After the test has been completed, slide the test strip ejector to pop out the test strip. Ejecting the test strip or pressing the back button will return you to your last screen. 76 Equil Patch Insulin Pump System Note Your blood glucose level is automatically saved to history upon leaving the BG meter function. Apply blood samples to the edge of the strip until the test window is full. The PDA screen will begin to count down when there is adequate blood. If the test window is not full, you may add additional blood within three seconds. If not enough blood has been applied, an error will be displayed. Please discard and use a new test strip. If you see that the test window is not full, but the countdown begins anyway, please discard and use a new test strip. Figure 98 77 10.7 Comparing Meter and Lab Results Your PDA's blood glucose meter and laboratory equipment both report glucose concentrations in the serum or plasma component of your blood. However variations between the two are normal, and your meter results and laboratory results may be slightly different. To ensure a reasonable comparison between your meter and laboratory results, please follow these guidelines:
1 Make sure the PDA's meter is working properly. 2 Comparisons will be more accurate if you do not eat for at least four hours
(preferably eight hours) before testing. 3 Bring your PDA, test strips, and control solution to the lab. 4 Ensure that the time between tests with your PDA and the laboratory is within 15 minutes. Equil Patch Insulin Pump System 5 Wash and dry your hands before obtaining a blood sample. 6 Make sure you closely follow the instructions in this manual. Test results may show small deviations, this may due to the following reasons:
Blood oxygen and red blood cell count vary from person to person, and even within the same person. The glucose meter tests blood glucose concentrations for the widest range of people possible. If the users blood indexes fall within the middle of the range, the result will be ideal. Otherwise, there will be some small deviations. (The deviations should be within the range allowed by local government.) 10.8 Quality Control Tests Control solution is a glucose solution of known concentration that is used to confirm that the PDA's meter and test strips are working properly. Normally, you should use Control Solution 1, and Control Solution 2 should only be used for secondary testing. Control Solution must be purchased separately. Please use control solution to perform quality control tests which can verify that the PDA's meter is working properly. You should perform a control solution test if you suspect that the meter or test strips are not working properly, if you suspect that your test results are inaccurate or inconsistent with the way you feel, or if you suspect the meter is damaged:
1 If the display is on, insert a test strip and the blood glucose meter screen will appear. Check mark the control solution checkmark box to indicate that you are doing a quality control test. The PDA will display an animation as in Figure 99. Shake the control solution bottle, gently squeeze out the control solution, discard the first drop, and drop the second drop onto a clean nonabsorbent surface. Now touch the second drop to the sample area of the test strip. Do not let the bottle come into 78 Equil Patch Insulin Pump System contact with the test strip. 79 Figure 99 2 When enough control solution has been applied, the screen will count down 5 seconds and then display the test result as in Figure 100. The result is displayed in the top half of the screen. If the result falls within the range printed on the test strip package (typically CTRL1) the device is working properly. Note If a big bubble forms, wipe with clean cotton paper, and then do the following: If the test window is not full, do now add more solution. Discard and try again with a new strip. Equil Patch Insulin Pump System If the control solution results are outside of the reference range:
Confirm you are matching the correct range. Control Solution 1 results should be matched to the CTRL1 range printed on the test strip vial (or foil pouch). Check the expiration date of the test strip and control solution. Make sure that the packages have not been opened for more than 6 months. Discard any expired test strips and control solution. Confirm that you are testing within the correct temperature range (15-30 C). Make sure that the test strip vial and control solution bottle have been tightly closed. Make sure that you are using the correct brand of control solution. Make sure you are following the user guide instructions properly. After checking all of the conditions above, repeat the quality control test with a new test strip. If the quality control test results are still 80 Figure 100 3 After the test has been completed, slide the test strip ejector to pop out the test strip. Note The control solution test results will not be stored in your history and the test result tags will be greyed out. Equil Patch Insulin Pump System From the Home Screen, choose the Actions button and then the Enter BG Reading Manually button to enter the manual entry screen (Figure 101). Using the
+ and - buttons, enter your blood glucose reading, select the appropriate tag (Before/After exercise, Before/After meal), and press Save. Now press the Back button to exit this screen. Note After a reading is saved into history, it cannot be modified. If you would like to enter another BG result, exit by pressing the Back button and re-enter the Enter BG Reading Manually screen. Note If the Bolus Calculator is enabled in the Settings Menu, the button will turn green after a blood glucose reading has been recorded. See Chapter 11 outside of the range printed on the test vial (or foil pouch), there may be a problem with your meter. Please seek help and contact your dealer. Control Solution 1 is sufficient for most self testing needs. If you think the PDA or strips may not be working correctly, you may also want to do a level 2 test. Repeat the above steps using Control Solution 2, see if the results fall within the CTRL2
(Control fluid 2) range printed on the label. For confirmation of results, Control Solution 1 tests should fall within the CTRL1 range, and Control Solution 2 tests should fall within the CTRL2 range. 10.9 Entering Your Glucose Reading Manually You can also enter your blood glucose reading manually. This is especially useful if you use a separate blood glucose meter. The entry will be stored in your history, and can be used with the bolus calculator. 81 Equil Patch Insulin Pump System BG Reminder Settings screen (Figure 102). Figure 101 10.10 Settings From the Home Screen, choose Settings/BG Settings. Press BG Reminder Settings to enter the Figure 102 Press to add a new reminder and a window will open (Figure 103). Enter the time and the Reminder Name, and press OK. 82 Equil Patch Insulin Pump System Figure 104 Note If a BG Reminder is activated, the icon will appear in the Status Bar. Figure 103 Note If you would like for this reminder to repeat every day, click the check mark box labeled Repeat this Reminder?
Pressing the OK Button will return you to the main BG Reminders screen and your new BG reminder will appear. Now, you can enable/disable the reminder by checking/unchecking the box (Fig 104). 83 Equil Patch Insulin Pump System 10.11 Blood Glucose Meter Troubleshooting Note BG Alerts consist of one short tone (beep), one short vibration, and sometimes a pop-up window that occur simultaneously. BG Alert Message Message Type Solution BG Meter initialization error Audio and Vibration Alert with Message Window Restart your PDA. If the problem persists, contact your distributor. Test strip was removed during the test Test strip is contaminated, used, or the blood sample is added to the test strip prematurely Insufficient sample Temperature exceeds operation range Test result is below the measurement range Test result is above the measurement range Check Ketones Audio and Vibration Alert with Message Window Audio and Vibration Alert with Message Window Audio and Vibration Alert with Message Window Audio and Vibration Alert with Message Window Audio and Vibration Alert with Message Window Audio and Vibration Alert with Message Window Audio and Vibration Alert with Message Window Repeat the test and ensure test strip remains in place. Retest with a new strip. Retest with a new strip. Make sure there is enough blood to fill the test window. Move to a place within the normal operating temperature range and repeat the test. Repeat test. If you see the same result, contact your healthcare professional immediately. Repeat test. If you see the same result, contact your healthcare professional immediately. Check Ketones and contact your healthcare professional immediately. 84 Equil Patch Insulin Pump System 11 Bolus Calculator Note 11.1 Introduction Before administering a bolus, patients usually need to calculate the amount of insulin to administer based on parameters such as the amount of carbohydrates they are eating. This process can be prone to errors because there are many parameters to consider. The Bolus Calculator requires the following information:
1) Current blood glucose level (from internal BG meter) 2) Target blood glucose level (user setting ask your doctor) 3) Carbohydrate ratio (ask your doctor) 4) Carbohydrate intake (user input) 5) Insulin sensitivity factor (ask your doctor) 6) Negative/Reverse correction (user setting ask your doctor) 7) Active insulin time (ask your doctor) The Bolus Calculator suggestion is The PDA contains a powerful bolus calculated as follows:
Bolus Suggestion =
Meal Bolus + Correction Bolus Active Insulin Meal bolus is used to compensate for increased blood sugars due to eating:
Meal bolus (U) =
Carb Intake (g) Carb Ratio calculator that can suggest a bolus size based on your input. Once the settings are configured properly, the bolus calculator can make a bolus size suggestion after you test your blood glucose level and enter the amount of carbohydrates that you will be eating. The bolus calculator can also take into account the amount of insulin that is currently being used in your body and make corrections to the suggested bolus size. 85 Equil Patch Insulin Pump System Correction Bolus is used to bring your current BG level to the target BG level:
Correction Bolus (U) =
Current BG Level-Target BG Level (mmol/L) Insulin Sensitivity Factor (mmol/L/U) Note If Negative Correction is ON, a correction bolus is always calculated. If Negative Correction is OFF, the correction bolus will only be calculated if your current BG level is HIGHER than the target BG level. Active Insulin: Insulin normally is absorbed in the body within about 4-6 hours. If you have recently taken a bolus, there could be active insulin still in your body. The Bolus Calculator automatically subtracts the amount of active based on your last bolus and the Active Insulin Time you enter in the settings. Note The Bolus Calculator is disabled by default. Please enable this feature in the Settings menu as described in Chapter 11.3 . Note The Bolus Calculator uses settings that are preset by the user. These settings should be entered under the supervision of your healthcare professional. 11.2 Using the Bolus Calculator 1 The Bolus Calculator function will be enabled after you use the internal blood glucose meter or you enter your BG level manually and save. Press the Bolus Calculator button and the calculator will ask if you will be eating now (Figure 105). 86 Equil Patch Insulin Pump System b) If you will be eating, choose Yes and continue to the next step. 2 In the dialog box, enter the total amount of carbohydrates that you intend to eat
(Figure 106) and press OK to move to the next step. Note You can estimate the amount of carbohydrates contained in your food by reading the food packaging, consulting carb counting books, or by referring to the PDAs food library. The amount of food and preparation method can have a large effect on the total amount of carbs. Figure 105 a) If you do not intend to eat and do not want a meal bolus, choose No and skip to step 3. Note If you are not eating, the bolus calculator will not take into account carbohydrates that you will eat. 87 Figure 106 Equil Patch Insulin Pump System 3 The next page is the suggested bolus screen (Figure 107). The top of the page is the suggested bolus size, the middle of the page are the calculation parameters, and the bottom of the page are action buttons. Figure 107 a) Bolus Amount: The suggested bolus amount appears automatically in the bolus amount area. Pressing the number will open a dialog box that will allow you to change the number. b) Calculation Parameters: This area shows the parameters that have been used to calculate the suggested bolus, including BG Reading, carb intake, and active insulin. The last item of this suggestion is the bolus suggestion. Note If the user has enabled the extend bolus feature, these parameters will also be shown. c) Action Buttons Extend Bolus: Press to choose extended bolus features (see Chapter 6.4). Start: Press to begin the bolus. A confirmation window will open, press OK to confirm or Cancel to abort. Details: Press to open a window that describes how the suggested bolus was calculated in detail. 88 Equil Patch Insulin Pump System Note Note The Bolus Calculator calculates a suggested bolus value. Please talk to your doctor about using this function. The next five settings will only be displayed if the Bolus Calculator function is ON. Note Your blood sugar reading is only valid for 10 minutes. If you do not issue a bolus within 10 minutes of your test, please test again to calculate a new bolus value. Note If your blood glucose reading is above or below the measurement range, the Bolus Calculator will be disabled. 11.3 Settings From the Home Screen, you can navigate to the Bolus Calculator settings by pressing Settings then Insulin Delivery Settings. 89 1 Target Blood Glucose Range Set the default Target Blood Glucose Range first. If desired, you can set different Target Ranges for different time periods. 2 Carbohydrate Ratio Set the default Carbohydrate Ratio first. If desired, you can set different Carbohydrate Ratios for different time periods. Note Carbohydrate Ratio is defined as the amount of carbohydrates that can be broken down per unit of insulin and is used to calculate the meal boluses. Since everyone has a different metabolism, set this value under the guidance of a physician. Equil Patch Insulin Pump System 3 Insulin Sensitivity Factor (ISF) Set the default Insulin Sensitivity Factor first. If desired, you can set different ISF's for different time periods. Note Since all everyone's values are different, choose your settings under the guidance of your physician. 4 Negative Correction Click to enable or disable the Negative Correction feature. 5 Active Insulin Time Set the default Active Insulin Time desired. 90 Equil Patch Insulin Pump System 12 History 12.1 Viewing Your History From the Home Screen, press the History button to view your records. 12.1.1 Daily Log After you press the History button, the PDA will display the Daily Log if the PDA is held in portrait orientation (Figure 108). In this screen, you can browse your historical records and view daily totals and other statistics. 91 Figure 108 Press the date near the top of the screen to open a window in which you can choose any calendar day, or press the button to scroll to the previous or next day. or Below the date, you can see the days BG average, Total Carbs, Total Insulin, and
% of total insulin that was for boluses. Equil Patch Insulin Pump System The grey area shows time-stamped The Graphs show two types of event entries such as BG readings, changes in Basal Rate, and Bolus sizes. You can use your finger to scroll up and down through the list. Also, you can filter the results by using the checkmark boxes beneath the list. 12.1.2 Graph Display If you hold the PDA in landscape orientation, the PDA will show the days information in Graph Display mode (Figure 109). Figure 109 information:
Blood Sugar/Carbohydrates: For 1 each blood glucose test reading, a dot is shown on the upper graph. Each record of carbohydrate intake is shown with a green vertical line. Insulin Delivery Amount: Basal rates 2 are shown as the blue waveform. Boluses are shown as blue vertical lines. Users can display or hide information in a graph by using the checkboxes. Detailed information appears by placing a finger on the graph in the desired area. Note To change the day, return to the Daily Log screen (portrait orientation), change the day, and turn the PDA back into Graph Display mode 92 Equil Patch Insulin Pump System 12.2 Historical Averages From the Daily Log screen, press the button to enter the Historical Averages screen. 12.2.1 Historical Averages List Hold the PDA in portrait orientation, and the screen displays the Historical Averages List (Figure 110). Average blood glucose and insulin delivery information can be seen on this page. Use the top bar to change the number of days to average. 93 Figure 110 At the bottom of the screen, you can choose different filters to show, for example, the averages of all readings that were taken Before/After Exercise, or Before/After a meal. Equil Patch Insulin Pump System 12.2.2 Historical Avgs Calendar Carbs eaten, and bolus sizes. After entering the Historical Averages page, you can view the Calendar mode by rotating the PDA to landscape orientation
(Figure 111). This view allows you to see your hourly data in a calendar format. This information includes BG readings, carbohydrates, and boluses. At the very top of the screen, you can and change week by pressing the buttons. Figure 111 The left side of the screen shows the time, while the top of the screen shows the day. You can scroll through different hours and tap different time periods to view detailed information regarding BG level, 94 Equil Patch Insulin Pump System 13 General Settings From the Home Screen, you can navigate to General Settings by pressing Settings and then General Settings (Figure 112). Figure 112 95 13.1 Time and Date a) Press the Date and Time option to open the Date and Time settings. b) Press the Date option to adjust the date. c) Press the Time option to adjust the time. d) 24-Hour Format: Check the box to have the time displayed in 24 hour format, or leave the box empty for 12 hour format. Warning Execution of the basal rate time periods and history records are directly affected by the time and date settings. Therapy must be suspended before time and date settings can be modified. 13.2 About the System From General Settings, choose About System. Equil Patch Insulin Pump System 1 Software version: Shows the software version of PDA and Pump PDA Serial Number: Shows the serial 2 number of the PDA. Pump Serial Number: Shows the 3 serial number of the pump that is currently being controlled by the PDA. (This number is also printed on the patch pump housing) 13.3 Language From General Settings, choose Language. The language can be changed using this option. 13.4 Memory Card From the General Settings screen, choose SD Card. Total Space: Displays the total 1 capacity of your memory card. 2 much memory is available for storage in your memory card. Available Space: Displays the how 3 History Export: Exports the history to a tab delimited file onto the memory card for backup. 13.5 Display From the General Settings screen, press the Display option. 1 Brightness: Choose the Brightness option to adjust the display brightness. You can manually adjust the screen brightness, or choose Automatic Brightness to have the PDA adjust automatically. 2 Screen Timeout: Choose the Screen Timeout option to adjust the amount of time that the display will turn off due to inactivity. Note The display backlight timeout is set to 5 seconds and cannot be changed. Note Lowering the display brightness can extend the battery life dramatically. 96 Equil Patch Insulin Pump System 13.7 Bluetooth Note The Bluetooth function requires a microSD card to be installed. From the General Settings screen, choose Bluetooth (Figure 113). 13.6 User Settings Press User Settings to enter the User Password: For security, choose Username: Add the users name here. Settings. 1 2
"password" to force the user to enter a password during power-on and wake up. The password must be 6 characters, which can be any combination from the letter "A-
F" and the number "0-9". If you forget your password, you can use the Pump Serial number to unlock. 3 password. Change Password: Use to reset the Restore Factory Settings: All settings 4 reset to the factory defaults. Note Once the factory settings have been restored, all saved settings will be lost
(except for time). Please make a note of all important settings before restoring factory settings. Note Before restoring factory settings, the pump must be unpaired from the PDA. 97 Figure 113 Equil Patch Insulin Pump System 1 Bluetooth On/Off: Check the checkbox to turn on Bluetooth. The Bluetooth logo will appear in the status bar. More options will appear if Bluetooth is on. 2 Machine Name: Choose Machine Name to give your PDA a unique name. device (paired, unpaired) will be shown underneath the device name. Figure 114 3 Visibility: Check the checkbox to allow other Bluetooth devices to detect the PDA. This function will timeout after 120 seconds. 4 Search for Devices: Press this button to search for other Bluetooth devices that are within range. A list of devices will appear in the Bluetooth Devices section (Figure 115). The status of the Figure 115 5 Using the devices in the list, the PDA has following Bluetooth options:
If a device in the list is not paired, press the device name to pair with the PDA and a pop up window will open to enter the 98 Equil Patch Insulin Pump System pairing code. Enter the code and accept to pair a new device. Figure 116 1 If a device is already paired with the PDA, pressing the device name will open a dialog box (Figure 117) that will allow you to either export history via Bluetooth, or unpair the device. Figure 117 99 Equil Patch Insulin Pump System 14 Additional Features 14.1 Audio Player The PDA also contains an audio player that can be used to play training instruction audio files. From the Home Screen, choose the Actions button and then the Audio Player button. 14.2 Auto-Off The pump system also has an automatic shutdown (auto-off) feature. This function can be enabled by checking the check box on the Settings - Insulin Delivery Settings -
Auto Off and then choosing the time delay before automatic shut down. When the auto-off feature is turned on, the pump will automatically stop delivery if there is no user input (button push) for a set amount of time. 15 minutes before shutdown, the PDA will begin to beep to issue a warning that auto-off will occur soon. If there is still no button push, the pump will stop delivery and both the pump and PDA will issue an alarm to tell the user that delivery has stopped. Note The auto-off feature is disabled by default. If the pump ceases operation because of the auto-off feature, the reservoir will need to be replaced to continue operation. 14.3 Food Database The food database is an extra function that can provide carbohydrate content data for various foods. From the Home Screen, choose the Actions button and then Food Database. Not only can you browse the database, you can manually add, edit, and delete food data. 100 Equil Patch Insulin Pump System 15 Suspend/Resume 15.1 How to Suspend/Resume Occasionally, you may need to temporarily stop insulin delivery by using the Suspend function. This can happen, for instance, if you temporarily do not require any insulin infusion, or need to remove the pump from the infusion set. From the Home Screen, choose the Suspend button to temporarily stop insulin delivery.A confirmation dialog box opens, as shown in Figure 118, click OK to suspend or Cancel. You can also choose to stop delivery and allow the pump to rewind. Remember that rewinding the pump will require priming the reservoir again. 101 Figure 118 After Suspend mode has been activated, the PDA returns to the Home Screen, and the information area of the Home Screen will display the amount of time that insulin delivery has stopped. The Pause button will become a Resume button, as Figure 119. Note While in Suspend mode, the PDA will beep every 15 minutes to remind you that delivery has stopped. Equil Patch Insulin Pump System Figure 119 If you would like to resume insulin delivery, press the Continue button. A confirmation dialog box will open (Figure 120). Choose OK to resume insulin delivery. Figure 120 Note If a bolus is in progress, you cannot enter Suspend mode. You must first cancel the bolus before suspending delivery. 102 Equil Patch Insulin Pump System 16 Alarms and Troubleshooting The patch pump system has a comprehensive safety system to check if abnormal situations require immediate attention. The system will send notification alarms using sound, LEDs, or vibrations as well as provide information on the PDA display. The insulin pump alarms are notifications of pump device errors, not direct physiological harm. The insulin pump system contains two parts the patch pump detects and sends the alarms, and the PDA receives the alarms and notifies the user. The insulin pump system only contains medium and low priority alarms no high priority alarms (as defined by ISO standards). Medium priority alarms occur when the delivery function has stopped due to technical failure, requiring the user to intervene in the operation of the pump, 103 change the pump, or possibly inject insulin manually to control BG levels. Low priority alarms occur to alert the user that something will occur in a short period of time, but insulin delivery continues normally. Users should be aware of this information and make plans in advance to ensure that treatment continues reliably. Note There are no alarms to indicate old insulin or to detect insulin leaks. The user should be aware if these situations happen. Note If the insulin pump and PDA start up normally without alarms, the alarms system is working properly. Note If the power is lost (battery empty), the alarm records and related settings will not be lost, even after more than 30 seconds of no power. Equil Patch Insulin Pump System Note You cannot modify the alarm settings, including alarm volume. PDA Alarm Priority Level s Alarm Level Medium Priority Visual Signal Audio Signal Flashing Yellow Light Three consecutive beeps Low Priority Steady Yellow Light Two consecutive beeps Patch Pump Alarm Priority Levels Alarm Level Medium Priority Visual Signal Flashing Yellow Light Low Priority Steady Yellow Light Audio Signal Vibration Signal None None Yes Yes Audio Alarm Volume Device Sound Pressure LeveldB Patch Pump None PDA 60-90 104 Equil Patch Insulin Pump System 16.1 Patch Pump Alarms Alarm Description Priority Level Alarm Signal Solution/Action No Insulin Remaining Vibration Medium Blockage Detected
(Occlusion) Unexpected Delivery Stoppage Medium Medium Pump Battery Exhausted Medium Cannot Give Full Bolus/Dose Low Low Pump Battery Level is Low Low LED, Vibration LED, Vibration LED, Vibration LED, Vibration LED, Vibration 105 There is no more insulin and delivery has stopped. The pump will automatically rewind. Replace the reservoir and check your blood glucose level. Insulin delivery has stopped. Replace the reservoir/infusion set and check your blood glucose level. Insulin delivery has stopped. Check your BG level. Replace reservoir/infusion set. If problem persists, contact the supplier for guidance. Insulin delivery has stopped. The pump will automatically rewind. Please replace the depleted battery with a fully charged one. There is not enough insulin left in the reservoir to execute the requested bolus. Prepare a new reservoir to be used after the old one is empty. The pump battery level is below 5%. Please prepare a fully charged battery for replacement Equil Patch Insulin Pump System 16.2 PDA Alarms Alarm Description Priority Alarm Signal Solution/Action No Insulin Remaining LED, Vibration Medium Blockage Detected
(Occlusion) Unexpected Delivery Stoppage Medium Medium Pump Battery Exhausted Medium Cannot Give Full Bolus/Dose Low Pump Battery Level is Low PDA battery exhausted PDA Failure Low Low Low Low LED, Vibration LED, Vibration LED, Vibration LED, Vibration LED, Vibration LED, Vibration LED, Vibration The reservoir is empty and insulin delivery has stopped. The patch pump will automatically rewind. Replace the reservoir and check your blood glucose level. Insulin delivery has stopped. Replace the reservoir/
infusion set and check your blood glucose level. Insulin delivery has stopped. Check your BG level. Replace reservoir/infusion set. If problem persists, contact the supplier for guidance. Delivery has stopped. The patch pump will automatically rewind. Please replace the depleted battery with a fully charged battery. There is not enough insulin left in the reservoir to execute the requested bolus. Prepare a new reservoir to be used after the old one is empty. The pump battery level is below 5%. Please prepare a fully charged battery for replacement The PDA battery level is below 5%. Connect to charger. Restart the PDA. If the problem persists, contact your distributor for repair or replacement. Note If a medium priority alarm occurs, the patch pump will automatically rewind and stop all insulin delivery. A pop-up window will appear on the PDA display to show more information and proposed solutions to the alarm. Press OK to close the pop-up window. You must now replace the reservoir to re-initialize the system and continue delivery. Note When the PDA gives an alarm signal, it will also vibrate to ensure the user is notified. Note Low priority alarms appear only once and do not repeat 106 Equil Patch Insulin Pump System The alarm system is distributed if a pump sensor detects a problem it will issue an alarm within 0.2 seconds. The PDA will receive the information and issue an alarm within 4 seconds. 16.3 Alarm System Delay The alarm system has an inherent delay between the two components, as shown in Figure 121:
T2-T1: The time it takes for a safety sensor in the patch pump to detect an alarm 0.1s. T3-T2The amount of time between detecting an alarm and issuing an alarm signal within the patch pump 0.1s. T4-T3: The time it takes for the pump to send the alarm information wirelessly to the PDA 4s. T5-T4The amount of time between when the PDA receives the alarm to issuing the alarm signal 0.1s. ALARM SIGNAL generation e l b a i r a v d e z i l a m r o N N O I T I D N O C M R A L A L A C G O L O I S Y H P I Algorithm variable response Instantaneous signal from PATIENT ALARMLIMIT Figure 121 Graphical Representation of Alarm Delay 107 Equil Patch Insulin Pump System 17 Maintenance 17.1.2 PDA Your patch pump and PDA are precision instruments. Improper use and maintenance will result in decreased accuracy or even pump failure. Please read this chapter carefully to learn how to properly care for your patch pump system. 17.1 Cleaning 17.1.1 Pump 1 Clean the outer surface using a mild detergent and a soft damp cloth. Use another cloth to dry. 2 Disinfect with an alcohol wipe. 3 Do not use solvents, nail polish remover, or paint thinner to scrub the outer surface. 4 Keep the pump dry, avoid water. 5 Do not use any lubricant. 1 Clean the outer surface using a mild detergent and a soft damp cloth. Use another cloth to dry. 2 Disinfect with an alcohol wipe. 3 Do not use solvents, nail polish remover, or paint thinner to scrub the outer surface. 4 Keep the PDA dry, avoid water. 5 Do not use any lubricant 6 Keep the test strip port area clean. 17.1.3 Lancing Device As needed, use a soft damp cloth moistened with soap and hot water to wipe the surface. Do not immerse the lancing device in water. 17.2 Avoid Extreme Temperatures 1 Avoid exposing the pump and PDA to temperatures above 40 and below 0. 2 Insulin solutions freeze near 0 and degrade at high temperatures. If you are 108 Equil Patch Insulin Pump System outside in cold weather, wear your pump close to your body and cover it with warm clothing. If you are in a warm environment, take measures to keep your pump and insulin cool. 3 Do not steam sterilize or autoclave your pump or PDA. 17.3 Avoid Immersion in Water The patch pump is rated IPX4
(splashproof). Do not bathe, swim, or otherwise immerse your pump in water. If you accidentally soak the pump with water, it may not function correctly. The PDA is not splashproof, and thus should be kept away from water at all times. 17.4 Test Strips store test strips in heat or direct sunlight. Do not refrigerate or freeze test strips. Do not store or use strips in a humid environment, such as a bathroom. Do not store the PDA, test strips, or control solution near bleach or cleaning agents that contain bleach. Close the cap on the vial immediately after removing a test strip. Use the test strip immediately after removing it from the package. Do not use expired test strips. Doing so may lead to inaccurate results. Note The test strip label contains the expiration date in year-month format. For example, 2019-01 indicates that the test strips are valid until January 2019. Use only MicroTech's Exactive EQ glucose test strips with the PDA. Store test strips in a clean, dry environment at 5-30 (41-86 ). Do not Special Instructions for Test Strips Sold in a Vial Test strips should be stored in the tightly capped vial that is provided. 109 Equil Patch Insulin Pump System Do not store test strips outside of the provided vial. Test strips must be stored inside the original vial with the lid tightly sealed closed. Do not transfer test strips from the provided vial into another container. Close the cap on the vial immediately after removing a test strip. A new vial of test strips may be used for 6 months after first being opened. Please take note of the date that the vial was first opened,and discard after 6 months. Test Strip Precautions For in vitro diagnostic use. Use the test strip immediately after removing it from the package, otherwise the test results may not be accurate. Do not use test strips that are torn, bent, or damaged in any way. Do not reuse test strips. Keep the test strip packaging away from children and pets. Consult your physician or healthcare professional before making any changes in your treatment plan based on your blood glucose test results. Please refer to the test strip instructions for more detailed information. 17.5 Control Solution Control solution is a glucose solution of known concentration that is used to confirm that your PDA blood glucose meter and test strips are working properly. It is important to run a quality control test regularly to make sure that you are getting accurate results. You should perform a quality control test in the following situations:
When you suspect that the meter or test strips are not working properly. When you suspect that your test results 110 Equil Patch Insulin Pump System are inaccurate, or inconsistent with how you feel. If the control solution is cold, do not use until it has warmed to room temperature. When you suspect that your meter has been damaged. After cleaning your PDA. Refer to Chapter 10.8 for instructions on how to perform a quality control test. Storage and Handling Please review the following storage and handling instructions:
Store the control solution in the temperature range 5-30C (41-86F). Do not refrigerate or freeze the control solution. 111 Do not use expired control solution. Note The control solution label contains the expiration date in year-month format. For example, 2019-01 indicates that the test strips are valid until January 2019. Control solution may be used for 6 months after the bottle is opened for the first time. Please take note of the date that the bottle was first opened, and discard after 6 months. Do not use beyond the expiration date. Control Solution Precautions For in vitro diagnostic use. The control solution is for testing only outside of the body. Do not swallow or inject. Control solution should be shaken before use. Quality control tests should be carried Equil Patch Insulin Pump System out at 15-30C. Do not let the control solution bottle touch the test strip. Use only the control solution that is recommended for your meter. The control ranges shown on the test strip package are not recommended ranges for your blood glucose level. Your personal glucose range should be determined by your healthcare professional. Please refer to the control solution instructions for more detailed information. 17.6 X-Ray, MRI, and CT Scans If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, remove your pump and PDA before entering the room that contains this equipment. 17.7 Precautions Although the pump has multiple safety alarms, it cannot notify you if the infusion set is leaking or if the insulin has lost its potency. It is essential, therefore, that you test your blood glucose levels at least four times per day. If your blood glucose is out of range, check the pump and infusion set to ensure that the necessary amount of insulin is being delivered. 17.8 Wireless Connection The patch pump and PDA communicate wirelessly, and when the PDA sends instructions to the pump, they must be within an acceptable distance. The patch pump and PDA have a wireless communication range of 2 meters. The distance and surrounding environment have a large effect on the wireless signal integrity. Please follow the suggestions below to 112 Equil Patch Insulin Pump System Avoid wearing clothing that contains Avoid obstructions between the PDA maximize the wireless signal. 1 and pump, such as walls, floors, metal plates, people, etc. 2 metallic substances around the pump. 3 radiation. 4 from the pump and PDA, even if the devices comply with national emission requirements. Wireless interference can still occur. Keep other wireless devices away Avoid strong electromagnetic If the signal strength between the patch pump and PDA is good, information will travel more quickly between the two. Always observe the wireless signal strength on the status bar before using the PDA. If the signal is weak or there is no signal, the PDA will not be able communicate with the pump. 113 Note If the signal is weak or there is no signal, check that you are avoiding the above four situations. If the signal is still weak, move the PDA closer to the pump. If the situation persists, please contact customer service. 17.9 Disposal When you replace the pump, portable controller and its attachments, please do not throw them away. Take them to an electronics recycling facility or return to our company. Do not discard damaged or expired batteries. Please dispose of batteries according to local recycling laws. 17.10 Transportation Avoid placing heavy objects on top of the patch pump and PDA. Avoid direct sunlight and rain. Transport according to the transportation conditions. Equil Patch Insulin Pump System 17.11 Storage If you are temporarily not using the pump system, store the components in a cool, dry, clean and well-ventilated area. If you decide not to use the pump for a prolonged period, the battery should be stored separately. 17.12 Other Considerations When dealing with potentially contagious substances (such as blood or reagents), use protective gloves or other protective coverings if skin exposure is likely. 114 Equil Patch Insulin Pump System 18 Specifications 18.1 General Specifications Model Number Size Weight Reservoir Capacity Operating Temperature Operating Humidity Storage Temperature Storage Humidity Water Resistance Alarm Prompts History Storage Display Battery Low Reservoir Alarm Threshold Auto-Off Auto-Off Time Range Memory Behavior During Power Off Wireless Frequency and Bandwidth Wireless Modulation Radiated Power Warranty 115 Patch Pump PDA MTM-2 112 x 57.2 x 12mmLxWxD 71gwithout battery
-
5-4041-104 10-93% (noncondensing
-40-55 5-95%noncondensing IPX0 AudioLEDYellow, Screen Browse by screen 3.2 inch color touchscreen 1000mAh MTM-1 59.5x40x11.1mmLxWxD 23gwithout batter or insulin 2ml 5-4041-104 10-93%noncondensing
-40-55 5-95%noncondensing IPX4 LEDYellowVibration Automatically Syncs to PDA None 70mAh 10-50Uin increments of 5U, 10U by default Enable/Disable Disabled by default 1-24 hours1 hour increments, 10 hours by default All settings and records retained after power off. Frequency2.402GHz~2.48 GHz Bandwidth1Mbps GFSK
-2dBm 4 Years Equil Patch Insulin Pump System 18.2 Delivery Attribute Specification Basal Rate Basal Programs 0.025 - 35 U/hr, programmed in increments of 0.025U/hr 3 Basal Programs, each with 48 time segments Maximum Basal Rate 0.1-35 U/hrDefault1.5 U/hr Base Basal Rate 0.025-35 U/HrDefault0.5 U/hr Temporary Basal Rate U/hr or % of basal ratelast 3 basal rates remembered, Default is Off Bolus Size 0.025U-25U 3 Presets Bolus Increment 0.025/0.05/0.1/0.5/1 U, Default:0.1 U Max Bolus Size 1-25Uprogrammed in 1U incrementsDefault is 10U Extended Bolus Programmed in U or % of total bolusDefault is Off Extend time0.5-8 hours in increments of 0.5 hr Quick Bolus On/Off, default is off Quick Bolus Increment 0.1-2UDefault is 0.1 U 18.3 Blood Glucose Meter Attribute Specification Measurement Range 1.1-33.3 mmol/L Test time Test Reminders HCT Range 5 Seconds 7 Reminders, which can be repeated 30-55%
116 Equil Patch Insulin Pump System 18.4 Bolus Calculator Attribute Bolus Calculator Specification On/Off, default is off Carb Ratio 1-150 g carb/U in 1 g carb/U increments, no default Insulin Sensitivity Factor 0.1-16.7 mmol/L/U in 0.1 steps, no default value Negative Correction Active Insulin Time On/Off, Default is On 2-6 hrs in 0.5hr incrementsno default value 18.5 Bolus Delivery Bolus Steps 0.05 U Volume per Step 0.5 L Time Interval Between Steps Infusion Speed per Minute 1s 3 U 18.6 Infusion Precision At 1U/h delivery rate, the error was measured at 0.4% as shown in Figure 122. Note The above test results were achieved using pump serial number 0A001 and reservoir batch number G13B25001 117 Figure 122 Equil Patch Insulin Pump System When the delivery rate was set to 0.01mL/hr, the measured flow is shown in Figure 123. Figure 123 18.7 Occlusion Detection
(Maximum Infusion Pressure) When the pressure inside of the reservoir reaches a maximum of 100kPa30kPa, the occlusion alarm will occur and the motor system will rewind automatically. 18.8 Occlusion Alarm Time When a fluid obstruction is detected, an occlusion alarm occurs. An average of 2.5U of insulin will be delivered before this alarm appears. The Table below shows three delivery speeds and the respective occlusion alarm delays using U100 insulin. Rate Typical Time Before Alarm Maximum Time Before Alarm Fast Rate
(3U/hr) Medium Rate
(1U/hr) Slow Rate
(0.025U/hr) 50 sec 53 sec 150 min 160 min 100 hrs 105 hrs 18.9 Overdose/Underdose The pump contains sensors whose sole purpose is to verify the infusion accuracy. 118 Equil Patch Insulin Pump System# Item Length m Cables Shielded Notes 1 PDA Charge Cable 1.0m Yes EUT DC 5V The use of accessories other than those specified for the device is not recommended. They may result in increased emissions or decreased immunity of the device. The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. The basic performance is described in the table below:
Performance Specific Description Infusion Precision within the 5%
If the actual amount of delivery is more or less than the requested amount, this is called an overdose or underdose. The sensors in the pump can detect overdose or underdose situations and compensate automatically, or issue an alarm. The maximum amount of bolus that can be delivered in a single fault is 0.25U. 18.10 Electromagnetic Compatibility These devices are intended for use in the electromagnetic environment specified in this chapter. The customer or the user of the device should assure that the device is used in such an environment. Portable and mobile RF communication interference may have an impact on the device. Please use the cables and accessories provided. The cable information is as follows:
119 Equil Patch Insulin Pump System IEC 60601-1-2Table 201 Guidance and manufacturer's declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment guidance RF Emissions CISPR 11 Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply. Class B Class A Complies RF Emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/Flicker Emissions IEC 61000-3-3 120 Equil Patch Insulin Pump System IEC 60601-1-2Table 202 Guidance and manufacturer's declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. Test Level Immunity Test IEC 60601 Electrostatic discharge (ESD) IEC 60601-4-2 6 kV Contact 8 kV Air Compliance Level Electromagnetic environment guidance 8 kV Contact 15 kV Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. 2 kV 1 kV for input/
output lines 1 kV Differential mode 2 kV Common mode 2 kV 1 kV for input/
output lines 1 kV Differential mode 2 kV Common mode Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.
<5 % Ut
(>95 % dip in Ut) for 0.5 cycle 40 % Ut
(60 % dip in Ut) for 5 cycles 70 % Ut
(30 % dip in Ut) for 25 cycles
<5 % Ut
(>95 % dip in Ut) for 5 s
<5 % Ut
(>95 % dip in Ut) for 0.5 cycle 40 % Ut
(60 % dip in Ut) for 5 cycles 70 % Ut
(30 % dip in Ut) for 25 cycles
<5 % Ut
(>95 % dip in Ut) for 5 s 3 A/m 400 A/m Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. The power frequency magnetic field should have the characteristics of power frequency magnetic field level at a typical place in a typical commercial and hospital environment Electrical fast transient burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 121 Equil Patch Insulin Pump System IEC 60601-1-2: Table 204 Guidance and manufacturer's declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. Test Level Level Compliance Electromagnetic environment guidance Immunity Test IEC 60601 Conducted RF IEC 61000-4-6 3VVrms 150kHz~80MHz 10VEngineering medical frequency band 150kHz~80MHz 3VVrms 10V
(Engineering medical frequency band Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.2 P d=1.2 P 80MHz~800MHz d=2.3 P 800MHz~2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000-4-3 10 V/m 80MHz~2.5GHz 3 V/m a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 122 Equil Patch Insulin Pump System IEC60601-1-2: Table 206 Recommended separation distances between portable and mobile RF communications equipment and the device These devices are intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the maximum output power of the communications equipment Maximum rated output power of transmitter Separation distance according to frequency of transmitter (m) 150kHz~80MHz d=1.2 P 80MHz~800MHz d=1.2 P 800MHz~2.5GHz d=2.3 P 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 123 Equil Patch Insulin Pump System 19 Appendix 19.1 Symbols Single Use Only Temperature Range Consult Instructions for Use Handle With Care Use By Manufacturer Lot Number Serial Number Type BF Applied Part Water Resistance Level IPX4 LOT SN Recyclable Do Not Dispose with Household Waste Sterilized by EO STERILE EO Keep Dry Biohazard Control Solution Range CTRL In Vitro Diagnostic Device IVD Keep Away From Heat and Radiation Sources Non-Ionizing Radiation Class 2 Equipment See Instructions for Use 124 Equil Patch Insulin Pump System Manufacturer: MicroTech Medical (Hangzhou) Co., Ltd. Address: No.9 Haishu Road, Yuhang District Hangzhou, Zhejiang 311121 China Phone: 011 -86-571-56782339 Website: http://www.microtechmd.com EC REP Lotus Global Co., Ltd. 1 Four Seasons Terrace West Drayton, Middlesex London, UB7 9GG, United Kingdom
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-07-16 | 2402 ~ 2480 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2019-07-16
|
||||
1 | Applicant's complete, legal business name |
Microtech Medical (Hangzhou) Co., Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0028573830
|
||||
1 | Physical Address |
No.9 Haishu Rd., Yuhang District
|
||||
1 |
Hangzhou 311121 Zhejiang, N/A
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
d******@compliancetesting.com
|
||||
1 | TCB Scope |
A2: Low Power Transmitters (except Spread Spectrum) and radar detectors operating above 1 GHz
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ATOV
|
||||
1 | Equipment Product Code |
061
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
R****** Z******
|
||||
1 | Title |
Registration Specialist
|
||||
1 | Telephone Number |
+86 0********
|
||||
1 | Fax Number |
+86 0********
|
||||
1 |
j******@163.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Patch Pump | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Global United Technology Services Co. Ltd.
|
||||
1 | Name |
R****** L********
|
||||
1 | Telephone Number |
86-0-********
|
||||
1 |
r******@gtstest.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC