1. Manuals
  2. Brands
  3. Wellion Manuals
  4. Medical Equipment
  5. MICRO-PUMP
  6. Manual

Wellion MICRO-PUMP Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
INSULIN PUMP SYSTEM
MANUAL

Advertisement

Table of Contents
loading

Summary of Contents for Wellion MICRO-PUMP

  • Page 1 INSULIN PUMP SYSTEM MANUAL...
  • Page 2 Foreword Thank you for choosing the Wellion MICRO-PUMP insulin pump system. We believe that the Wellion MICRO-PUMP will help you gain better control of your diabetes and will help you live a healthy and active life. This user guide is designed to help you understand insulin pump therapy and the operation of your Wellion MICRO-PUMP.

  • Page 3: Table Of Contents

    Table of contents Introduction Indications Patients Contraindications Before Use How to Use This Guide Getting Help Prepare for Emergencies Insulin Pump Precautions Portable Diabetes Assistant (PDA) Precautions Blood Glucose Test Module Precautions Important Safety Information Component Description Pump System Components Accessories Getting Started PDA Setup...
  • Page 4 Settings Boluses Understanding Boluses Manual Boluses Bolus Presets Extended Boluses Quick Bolus Cancelling a Bolus Settings Therapy Setup Infusion Set Setup Removing the Infusion Set Filling the Reservoir Assembling Reservoir to Pump Disassembling the Reservoir Replacing the Pump Replacing the Reservoir Setup The Built-in Blood Glucose Meter Operating Principle...
  • Page 5 Quality Control Tests Entering Your Glucose Reading Manually Settings Blood Glucose Meter Troubleshooting Bolus Calculator Introduction Using the Bolus Calculator Settings History Viewing Your History Historical Averages General Settings Time and Date About the System Language Memory Card Display User Settings Bluetooth Additional Features Audio Player...
  • Page 6 Pump Alarms PDA Alarms Alarm System Delay Maintenance Cleaning Avoid Extreme Temperatures Avoid Immersion in Water Test Strips Control Solution X-Ray, MRI, and CT Scans Precautions Wireless Connection Disposal Transportation Storage Other Considerations Specifications General Specifications Delivery Blood Glucose Meter Bolus Calculator Bolus Delivery Infusion Precision...

  • Page 7: Introduction

    Introduction Indications This product is intended for subcutaneous (beneath the skin) delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro).

  • Page 8: Before Use

    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 the Wellion MICRO-PUMP, which can help you adapt to different situations (for example, workdays, weekends, and sick days).

  • Page 9: How To Use This Guide

    Please seek help from your healthcare professional if you encounter problems. Your local Wellion provider can provide technical support for the device, but cannot provide treatment advice for your medical condition. Prepare for Emergencies Patients with diabetes should always carry an emergency kit to quickly respond to any diabetes emergencies.

  • Page 10: Insulin Pump Precautions

    The company will try to assist, but does not bear the various related legal obligations arising from misuse. This product can only be used to administer U-100 insulin. Only Wellion disposable supplies should be used with the pump.

  • Page 11: Portable Diabetes Assistant (Pda) Precautions

    Do not drop or get wet as this could cause a malfunction. Blood Glucose Test Module Precautions • This module should only be used in vitro and can only be used with Wellion MICRO blood sugar test strips. Use of other brand test strips will result in incorrect test results.

  • Page 12: Important Safety Information

    Important Safety Information Do Not Immerse the Pump in Water The pump is splashproof (IPX4). Do not fully submerge the pump in water. If you plan to bathe, swim, or participate in other water activities, please suspend insulin delivery and remove the pump from the base. After you finish your activities, you may re-apply the pump to the base and continue pump therapy.

  • Page 13: Component Description

    Component Description Pump System Components Portable Diabetes Assistant (PDA) Pump Battery contacts Bolus Button Motor System Accessories 1. Cannula Inserter 2. Pump Battery 3. Pump Battery Charger...
  • Page 14 Warning: Use only accessories and disposables that are manufactured by the manufacturer, or with the Wellion MICRO brand name. Use of non- standard components can be unsafe 4. PDA Charger 5. PDA Charging Cable Warning: The included charger can be used in wall outlets rated at AC 110V-250V 50- 60Hz.

  • Page 15: Getting Started

    Getting Started PDA Setup 1. Remove the battery cover: Holding the PDA firmly with one hand, pry up the battery cover by inserting your fingernail Finger Hold until the slot shown in Figure 1. Figure 1 2. Insert a microSD memory card: Insert memory into the slot as shown in Figure 2.
  • Page 16 5. The PDA controls are shown in Figure 5: 10 11 Figure 5 (Power Button) Power ON: Press and hold this key and the PDA will vibrate, begin the startup process, and enter the home screen after about 30 seconds. Screen Off: If the PDA display is on, pressing the Power Button will turn off the LCD display and the PDA will enter standby mode.
  • Page 17 Power OFF: If the display is on, press and hold the power button to open a dialogue box to confirm that you would like to turn off the device. (Help Button) If you need help with commands or functions of the PDA, you can press the help button for more information.

  • Page 18: Charging The Batteries

    10. Blood Glucose Test Strip Port Inserting the correct Wellion MICRO blood glucose test strip into this port will activate the blood glucose test menu. For more information on how to use the blood glucose meter, refer to Chapter The Built-in Blood Glucose Meter.
  • Page 19 2. Insert the small end of the cable into the PDA, and the large end of the cable into the PDA charger as shown in Figure 6. 3. Connect the PDA charger to a power outlet. If the PDA is on, the battery icon will change to the charging icon.

  • Page 20: Settings Wizard

    5. Remove the pump battery as shown in Figure 9: 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.
  • Page 21 a. Choose the Date setting to open a dialog box (Figure 11) 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.
  • Page 22 2. Basic Basal Settings The second screen in the Settings Wizard shows the basic basal settings (Figure 14). Note: For a more detailed description of basal rates, see Chapter Understanding Basal Rate. Figure 14 a. Choose the Maximum Basal Rate setting to open a dialog box (Figure 15) that can be used to input the maximum basal rate.
  • Page 23 c. Choose the Temporary Basal Rate setting to open a dialog box (Figure 17) 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 Figure 17 units of insulin delivered per hour.
  • Page 24 a. The Bolus Increment setting (Figure 19) allows you to set the interval used when increasing or decreasing bolus amounts. b. The Maximum Bolus setting allows you to set an upper limit on the amount of insulin given in a single bolus (Figure 20).
  • Page 25 This feature is turned off by default. For more detailed information about this feature, see Chapter Bolus Calculator - Settings. Note: These two features are relatively advanced and your local Wellion MICRO-PUMP representant recommends proper training and practice before Figure 22 using these features.

  • Page 26: Home Screen

    6. Alert Options The fifth screen in the Settings Wizard shows the Alert Options (Figure 25). If you 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.
  • Page 27 Status Bar The Status Bar contains icons that describe the status of the pump and PDA. The icons shown on the left are generally related to the pump (blue), and the icons on the right are generally related to the PDA (green). Each Icon in the Status Bar is described below: •...
  • Page 28 Press the button at the middle of the Status Bar and it will enlarge as in Figure 27. 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.

  • Page 29: Lock Screen

    5. Settings: Press 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. Lock Screen If you press the power button to turn the display off, or the display turns off automatically after a period of non-use, the display can be turned on again by...
  • Page 30 Time and Date Display Area Displays the current time, day, month and year. Information Display Area Shows your last blood glucose level, the last bolus administered, and the current basal rate; or the 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.

  • Page 31: Basal Rate Adjustment

    Basal Rate Adjustment Understanding Basal Rate Basal insulin is the pump’s way to simulate the secretion of non-mealtime insulin. Even if a non-diabetic person fasts all day, there still is a small amount of insulin secreted. The pump’s basal insulin is used to simulate the micro-secretions of insulin. Base Basal Rate We have already set up the base basal rate in the Settings Wizard.
  • Page 32 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.
  • Page 33 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. button in the top row will reset all basal time periods. Note: The Quick Basal Program Setup is only an estimate of your daily basal needs.
  • Page 34 b. Editing a basal time period: You can edit a basal time period entry by pressing icon. c. Deleting a basal time period: You can delete a basal time period entry by pressing icon. The time period will revert to the base basal rate. Note: After deleting a basal time period, the PDA may merge adjacent basal time periods if the basal rates are the same.

  • Page 35: Editing Basal Programs (Graph Display)

    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 35.

  • Page 36: Activating A Basal Program

    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.
  • Page 37 Note: Each person’s physical condition is different. Set your temporary basal rate carefully under your doctor’s guidance. From the Home Screen, press the basal function button to enter the Basal Screen, make sure that the Current Basal Program tab is open, and press the Temporary Basal Rate button to bring up a temporary basal rate settings dialog box (Figure 37).

  • Page 38: Settings

    Settings From the Home Screen, choose “Settings – Insulin Delivery Settings” as shown in Figure 39 to change delivery settings. 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 basal delivery that can be administered by accident or misoperation.

  • Page 39: Boluses

    Boluses Carbohydrate Understanding Boluses Protein 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. Time Figure 40 Carbohydrates, proteins and fats all affect your blood glucose level differently (Figure 40).

  • Page 40: Bolus Presets

    While the pump is delivering, the PDA will revert to the Home Screen and display the bolus status (Figure 43). Figure 43 Unaprijed zadane postavke bolusa Bolus ekran sadrži tri programirana unaprijed zadana bolusa (slika 44). 3 Bolus Presets Figure 44...

  • Page 41: Extended Boluses

    You can set up each of the three preset boluses (they are empty by default). 1. Add Preset: If a preset is empty, you may press anywhere on the button to open the Preset dialog box (Figure 45). Edit the parameters to create a new Preset.
  • Page 42 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 of one’s carbohydrate absorption rate. Please consult with your professional healthcare provider before using this feature.

  • Page 43: Quick Bolus

    Quick Bolus The Wellion MICRO-PUMP 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.
  • Page 44 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 50). 2. The next time you press the Enter (Select) button the bolus size will increase by a predetermined increment.

  • Page 45: Cancelling A Bolus

    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 pump. The pump will give an audible alert which indicates that you can enter a quick bolus amount. 2.

  • Page 46: Settings

    Press the Cancel button and a confirmation window will appear (in PDA). Press OK to confirm. You can also cancel a bolus by pressing and holding the Quick Bolus button on the pump to cancel. Note: Cancelling a bolus delivery will cancel the total bolus (Amount Now and Extended amount).
  • Page 47 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.

  • Page 48: Therapy Setup

    Note: Infusion sets are comprised of a cannula pack and base. Be sure to use only infusion accessories from Wellion. Figure 53...
  • Page 49 3. Remove the protective sleeve as shown in Figure 4. Hold the inserter and align the front end with the bottom plate bayonet as shown in Figure 55. Press down, until you hear a “click” prompt to install it in Figure 54 place.

  • Page 50: Removing The Infusion Set

    Removing the Infusion Set Peel up one end of the tape as shown in Figure 58 and continue to peel away from the skin until the entire infusion set has been removed. Filling the Reservoir Figure 58 1. Remove the new reservoir from the packaging. 2.
  • Page 51 6. Remove the insulin vial from the fill adapter (Figure 63). 7. Pull the two release tabs (shown in Figure 64) away from the reservoir to release the fill adapter. Note: The fill adapter contains a needle, please dispose of properly. 8.

  • Page 52: Assembling Reservoir To Pump

    Assembling Reservoir to Pump Figure 66 illustrates the sequence to attach the reservoir and battery to the pump. Always install a fully charged battery with a newly filled reservoir. Be sure that the battery is inserted in the orientation shown in Figure 67. Figure 66 Figure 67...

  • Page 53: Disassembling The Reservoir

    Disassembling the Reservoir Holding the pump and reservoir in the orientation shown in Figure 68, bend the assembly along the seam line as shown until the reservoir separates from the pump. Be sure to recharge the battery immediately to make sure that a fresh battery is always installed with a new reservoir.

  • Page 54: Replacing The Pump

    Replacing the Pump Warning: Before continuing, please make sure you are familiar with frequently used pump setup operations such as installing/removing an infusion set, filling a new reservoir, and assembling/ disassembling the reservoir (Chapter Therapy Setup). This section explains how to connect a new pump to the PDA or replace an old one.
  • Page 55 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 Infusion Set Setup) and press Continue.
  • Page 56 Note: For safety reasons, the PDA can only control one pump at a time. Serial u u u u u u Number 2. Enter the New Pump Serial Number in the space provided (Figure 74) using the onscreen keyboard. Press the Back button to exit the keyboard and press Continue.
  • Page 57 5. Connect the pump to the infusion set as shown in Figure 78 and press Continue Figure 79. 6. Now choose whether or not to prime the cannula (Figure 80). 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).

  • Page 58: Replacing The Reservoir

    Replacing the Reservoir 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 Therapy Setup). If the insulin reservoir connected to your pump becomes empty, you should replace the reservoir.
  • Page 59 2. Separate the used reservoir from the pump (Chapter Disassembling the Reservoir), dispose of the old reservoir, and then assemble a filled reservoir and a charged battery to the pump as shown in the animation (Figure 83). Press Continue (Figure 84) to go to the next page.
  • Page 60 3. Holding the pump in the orientation shown in Figure 85, press the Prime Reservoir button (Figure 86). The plunger will begin to move slowly. Continue to press the button until you see a drop of insulin on the needle tip (Figure 85). The background of the “Next”...
  • Page 61 5. Now choose whether or not to prime the cannula (Figure 89). 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). Figure 89...

  • Page 62: The Built-In Blood Glucose Meter

    The Built-in Blood Glucose Meter Operating Principle The integrated blood glucose test meter uses an electrochemical biosensor containing glucose oxidase and detects β-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.

  • Page 63: Fingertip Testing

    Fingertip Testing Adjust the penetration depth to reduce the discomfort. 1. Remove the lancing device cap. Insert the lancet into the lancet holder until it comes to a complete stop. (Figure 90) 2. Twist off the safety cap from the lancet, save the safety cap for lancet disposal.
  • Page 64 5. Pull back the cocking barrel until you hear a click. Now the lancing device is loaded and ready to draw blood. (Figure 94) 6. Before taking a blood sample, wash your hands or use an alcohol swab to clean the area. Washing your Figure 94 hands in hot water increases blood circulation.

  • Page 65: Lancet Removal

    Lancet Removal 1. Unscrew the lancing device cap. Firmly push the needle into the safety cap. (Figure 97) 2. Use the eject button to remove the lancet. Please dispose of the used lancet properly. (Figure 98) Figure 97 Lancet Precautions: •...

  • Page 66: Ejecting Test Strips

    You can easily eject the test strip by sliding the ejector button as shown in Figure 99. Testing Blood Glucose If the display is on, insert a Wellion MICRO test strip Figure 99 and the blood glucose meter screen will appear (Figure 100).
  • Page 67 1. Test Result Area: Displays 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.

  • Page 68: Comparing Meter And Lab Results

    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.

  • Page 69: Quality Control Tests

    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.
  • Page 70 2. When enough control solution has been applied, the screen will count down 5 seconds and then display the test result as in Figure 104. 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.

  • Page 71: Entering Your Glucose Reading Manually

    If the quality control test results are still outside of the range printed on the test vial, 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.

  • Page 72: Settings

    Settings From the Home Screen, choose Settings/BG Settings. Press BG Reminder Settings to enter the BG Reminder Settings screen (Figure 106). Press to add a new reminder and a window will open (Figure 107). Enter the time and the Reminder Name, and press OK.

  • Page 73: Blood Glucose Meter Troubleshooting

    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. Alert Message Message Type Solution Restart your PDA. If the BG Meter initialization problem persists, contact your error distributor.

  • Page 74: Bolus Calculator

    Bolus Calculator 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.
  • Page 75 Correction Bolus is used to bring your current BG level to the target BG level: Correction Bolus (U) = Current BG Level-Target BG Level (mg/dL or mmol/L) Insulin Sensitivity Factor (mg/dL/U or 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.

  • Page 76: Using The Bolus Calculator

    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 109). a.
  • Page 77 3. The next page is the suggested bolus screen (Figure 111). 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. a. Bolus Amount: The suggested bolus amount appears automatically in the bolus amount area.

  • Page 78: Settings

    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.
  • Page 79 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.

  • Page 80: History

    History Viewing Your History From the Home Screen, press the History button to view your records. Daily Log After you press the History button, the PDA will display the Daily Log if the PDA is held in portrait orientation (Figure 112). In this screen, you can browse your historical records and view daily totals and other statistics.

  • Page 81: Historical Averages

    The Graphs show two types of information: 1. Blood Sugar/Carbohydrates: For 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. 2. Insulin Delivery Amount: Basal rates are shown as the blue waveform. Boluses are shown as blue vertical lines.
  • Page 82 Historical Avgs Calendar After entering the Historical Averages page, you can view the Calendar mode by rotating the PDA to landscape orientation (Figure 115). This view allows you to see your hourly data in a calendar format. This information includes BG readings, carbohydrates, and boluses.

  • Page 83: General Settings

    General Settings From the Home Screen, you can navigate to General Settings by pressing Settings and then General Settings (Figure 116). 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.

  • Page 84: Language

    Language From General Settings, choose Language. The language can be changed using this option. Memory Card From the General Settings screen, choose SD Card. 1. Total Space: Displays the total capacity of your memory card. 2. Available Space: Displays the how much memory is available for storage in your memory card.

  • Page 85: Bluetooth

    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. Change Password: Use to reset the password. 4. Restore Factory Settings: All settings reset to the factory defaults. Note: Once the factory settings have been restored, all saved settings will be lost (except for time).
  • Page 86 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 119). The status of the device (paired, unpaired) will be shown underneath the device name.

  • Page 87: Additional Features

    Additional Features 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. 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.

  • Page 88: Suspend/Resume

    Suspend/Resume 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 Figure 122 any insulin infusion, or need to remove the pump from the infusion set.

  • Page 89: Alarms And Troubleshooting

    Alarms and Troubleshooting The Wellion MICRO-PUMP system has a comprehensive safety system to check if ab-normal situations require immediate attention. The system will send notification alarms us-ing sound, LEDs, or vibrations as well as provide information on the PDA display.

  • Page 90: Pump Alarms

    PDA Alarm Priority Levels Alarm Level Visual Signal Audio Signal Medium Priority Flashing Yellow Light Three consecutive beeps Low Priority Steady Yellow Light Two consecutive beeps Pump Alarm Priority Levels Alarm Level Visual Signal Audio Signal Vibration Signal Medium Priority Flashing Yellow Light None Low Priority Steady Yellow Light...
  • Page 91 Insulin delivery has stopped. Check your BG level. Replace Unexpected insulin Medium LED, Vibration reservoir/infusion set. If prob- delivery stoppage lem persists, contact the sup- plier for guidance. Insulin delivery has stopped. The pump will automatically Pump Battery rewind. Medium LED, Vibration Exhausted Please replace the depleted...

  • Page 92: Pda Alarms

    PDA Alarms Priority Alarm Description Alarm Signal Solution/Action Level The reservoir is empty and insulin delivery has stopped. No Insulin The pump will automatically Medium LED, Vibration Remaining rewind. Replace the reservoir and check your blood glucose level. Insulin delivery has stopped. Blockage Detected Replace the reservoir/infusion Medium...
  • Page 93 The pump battery level is Pump Battery Level below 5%. Please prepare LED, Vibration is Low a fully charged battery for replacement PDA battery The PDA battery level is below LED, Vibration Exhausted 5%. Connect to charger. Restart the PDA. If the problem PDA Failure LED, Vibration persists, contact your distribu-...

  • Page 94: Alarm System Delay

    Alarm System Delay The alarm system has an inherent delay between the two components, as shown in Figure 125: • T2-T1: The time it takes for a safety sensor in the pump to detect an alarm ≤0.1s. • T3-T2: The amount of time between detecting an alarm and issuing an alarm signal within the pump ≤0.1s.

  • Page 95: Maintenance

    Maintenance Your 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 pump system. Cleaning Pump 1. Clean the outer surface using a mild detergent and a soft damp cloth. Use another cloth to dry.

  • Page 96: Avoid Extreme Temperatures

    The PDA is not splashproof, and thus should be kept away from water at all times. Test Strips • Use only Wellion MICRO blood glucose test strips with the PDA. • Store test strips in a clean, dry environment at 5-30 °C (41-86 °F). Do not store test strips in heat or direct sunlight.

  • Page 97: Control Solution

    • 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. •...
  • Page 98 • When you suspect that your test results are inaccurate, or inconsistent with how you feel. • When you suspect that your meter has been damaged. • After cleaning your PDA. Refer to Chapter Quality Control Tests for instructions on how to perform a quality control test.

  • Page 99: X-Ray, Mri, And Ct Scans

    • 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. 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.

  • Page 100: Disposal

    4. Keep other wireless devices away from the pump and PDA, even if the devices comply with national emission requirements. Wireless interference can still occur. If the signal strength between the 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.

  • Page 101: Other Considerations

    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.

  • Page 102: Specifications

    Specifications General Specifications Pump Model Number WELL19-00 WELL19-00PDA Size (L x W x D) 59,5 x 40 x 11,1mm 112 x 57,2 x 12mm Weight (without battery or insulin) (without battery) Reservoir Capacity Operating Temperature 5 - 40 °C Operating Humidity 10 - 93% (noncondensing) Storage Temperature -40 - 55 °...

  • Page 103: Delivery

    Radiated Power -2dBm Warranty 4 Years Delivery Attribute Specification Basal Rate 0,025 - 35 U/hr, programmed in increments of 0,025U/hr Basal Programs 7 Basal Programs, each with 48 time segments Maximum Basal Rate 0,1-35 U/hr, Default: 1,5 U/hr Base Basal Rate 0.025-35 U/Hr, Default: 0,5 U/hr U/hr or % of basal rate, last 3 basal rates remembered, Temporary Basal Rate...

  • Page 104: Bolus Calculator

    Bolus Calculator Attribute Specification Bolus Calculator On/Off, default is off Carb Ratio 1-150 g carb/U in 1 g carb/U increments, no default Insulin Sensitivity 0,1-16,7 mmol/L/U in 0,1 steps, no default value Factor Negative Correction On/Off, Default is On Active Insulin Time 2-6 hrs in 0,5hr increments, no default value Bolus Delivery Time Interval...

  • Page 105: Occlusion Detection (Maximum Infusion Pressure)

    Occlusion Detection (Maximum Infusion Pressure) When the pressure inside of the reservoir reaches a maximum of 100kPa±30kPa, the occlusion alarm will occur and the motor system will rewind automatically. 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.
  • Page 106 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: Item Length (m) Cables Shielded Notes PDA Charge Cable 1,0 m EUT DC 5V The use of accessories other than those specified for the device is not recommended.
  • Page 107 IEC 60601-1-2: Table 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 –...
  • Page 108 IEC 60601-1-2: Table 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. Electromagnetic environment –...
  • Page 109 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. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic environment –guidance...
  • Page 110 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...

  • Page 111: Appendix Symbols

    Appendix Symbols Single Use only Temperature Range Consult Instructions for Use Handle With Care Use By Type BF Applied Part Manufacturer Water Resistance Level Lot Number Recyclable Do Not Dispose with Serial Number Household Waste Sterilized by EO Keep Dry Biohazard Control Solution Range Keep Away From Heat and...
  • Page 112 INSULIN PUMP SYSTEM MicroTech Medical (Hangzhou) Co., Ltd. Service und Distribution: No.9 Haishu Road, Yuhang District MED TRUST Handelsges.m.b.H. Hangzhou, Zhejiang China Gewerbepark 10, LOTUS NL B.V. 7221 Marz, AUSTRIA Koningin Julianaplein 10, 1e Verd, www.medtrust.at; www.wellion.at 2595AA, The Hague, Netherlands...

This manual is also suitable for:

Well19-00Well19-00pda

Table of Contents