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.
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.
Note Figure 72 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 Figure 71 59 ® Equil Patch Insulin Pump System Continue.
to the new pump. After the new pump has been activated, the PDA will show a 3 From the confirmation screen (Figure 74), press the Continue button. confirmation screen (Figure 74). Figure 74 4 Holding the pump in the orientation shown in Figure 76, press the Prime Reservoir button (Figure 75). The plunger MTM-I 型号： 贴敷式胰岛素泵 will begin to move slowly. Continue to ! 序列号 XXXXXX IPX4 微泰医疗器械 （杭州） 有限公司 Serial Number press the button until you see a drop of insulin on the needle tip (Figure 76).
Connect the pump to the infusion set as shown in Figure 77 and press Continue.
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).
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.
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.
® Equil Patch Insulin Pump System 66
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 图81 insulin on the needle tip (Figure 81. Press Continue to go to the next step.
4 Connect the pump to the infusion set as shown in Figure 83 and press Continue.
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).
10 The Built-in Blood Glucose Meter but should be used for the diagnosis of diabetes. 10.3 Blood Sampling 10.1 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.
10.3.1 Fingertip Testing Adjust the penetration depth to reduce 2 Twist off the safety cap from the lancet, save the safety cap for lancet disposal. 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 4 5 comes to a complete stop. Figure 87 3 Carefully install the lancing device cap onto the lancing device, avoid touching the 4 5 lancet needle tip.
4 Adjust the puncture depth by rotating the depth adjustor (the lancing device has 5 puncture depth settings). To reduce 5 Pull back the cocking barrel until you hear a click. Now the lancing device is loaded and ready to draw blood. discomfort, choose the lowest setting that still produces an adequate blood sample.
Figure 91 Figure 92 7 Holding the lancing device against the side of the finger to be lanced, press the 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. release button and then put down the lancing device. Massage forward slowly from the base of your finger to the tip to 2 3 4 increase the sample size. 10.4 Lancet Removal 1 Unscrew the lancing device cap.
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. Figure 93 2 Pull out the lancet from the lancet holder. Please dispose of the used lancet • 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. properly.
10.5 Ejecting Test Strips The back side of the PDA contains a test 10.6 Testing Blood Glucose If the display is on, insert an Exactive strip ejector. You can easily eject the test EQ test strip and the blood glucose meter strip by sliding the ejector button as shown screen will appear (Figure 96). in Figure 95. Figure 95 Figure 96 After the strip has been inserted, apply blood as shown on the screen.
enough blood has been applied, the The scale above the reading shows screen will count down 5 seconds and then whether or not the result falls within the display the test result as in Figure 97. target range. If the result is outside of the range, the bar will be yellow. Test Result Area 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.
Note Your blood glucose level is automatically saved to history upon leaving the BG meter function. 10.7 Comparing Meter and Lab Results Your PDA's blood glucose meter and laboratory equipment both report glucose Apply blood samples to the edge of concentrations in the serum or plasma the strip until the test window is full. component of your blood. However The PDA screen will begin to count down variations between the two are normal, when there is adequate blood.
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 user’s blood indexes fall within the middle of the range, the result will be ideal.
contact with the test strip. 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.
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).
outside of the range printed on the test From the Home Screen, choose the vial (or foil pouch), there may be a problem Actions button and then the Enter BG with your meter. Please seek help and Reading Manually button to enter the contact your dealer. manual entry screen (Figure 101). Using the Control Solution 1 is sufficient for most “+” and “-” buttons, enter your blood self testing needs.
BG Reminder Settings screen (Figure 102). Figure 101 Figure 102 10.10 Settings From the Home Screen, choose Settings/BG Settings. Press BG Reminder Settings to enter the Press to add a new reminder and a window will open (Figure 103). Enter the time and the Reminder Name, and press OK.
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 Figure 104 Note If a BG Reminder is activated, the icon will appear in the Status Bar.
Note 10.11 Blood Glucose Meter Troubleshooting BG Alert Message BG Alerts consist of one short tone (beep), one short vibration, and sometimes a pop-up window that occur simultaneously. 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 Audio and Vibration Alert with Message Window Repeat the test and ensure test strip remains in place.
11 Bolus Calculator Note The Bolus Calculator requires the following information: 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.
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 The Bolus Calculator is disabled by default. Please enable this feature in the Settings menu as described in Chapter 11.3 . Note Note If Negative Correction is ON, a correction bolus is always calculated.
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 PDA’s food library. The amount of food and preparation method can have a large effect on the total amount of carbs.
3 The next page is the suggested bolus screen (Figure 107). The top of the page is amount area. Pressing the number will the suggested bolus size, the middle of the change the number. page are the calculation parameters, and b) Calculation Parameters: This area the bottom of the page are action buttons. open a dialog box that will allow you to shows the parameters that have been used to calculate the suggested bolus, including BG Reading, carb intake, and active insulin.
Note The Bolus Calculator calculates a suggested bolus value. Please talk to your doctor about using this function. 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 The next five settings will only be displayed if the Bolus Calculator function is ON. 1 Set the default Target Blood Glucose Range first. If desired, you can set different Target Ranges for different time periods.
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.
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.
The grey area shows time-stamped 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. 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. 12.1.
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.
12.2.2 Historical Avgs Calendar 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 Carbs eaten, and bolus sizes. At the very top of the screen, you can change week by pressing the buttons. and your hourly data in a calendar format. This information includes BG readings, carbohydrates, and boluses.
13 General Settings From the Home Screen, you can 13.1 Time and Date a) Press the Date and Time option to open the Date and Time settings. navigate to General Settings by pressing b) Press the Date option to adjust the date. Settings and then General Settings (Figure c) Press the Time option to adjust the time. 112). 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.
1 Software version: Shows the software version of PDA and Pump 3 History Export: Exports the history to a tab delimited file onto the memory card for backup. 2 PDA Serial Number: Shows the serial number of the PDA. 13.5 Display 3 Pump Serial Number: Shows the From the General Settings screen, press the Display option. 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.
13.6 User Settings Press User Settings to enter the User Settings. 1 Username: Add the user’s name here. 2 Password: For security, choose "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 "AF" and the number "0-9". If you forget your password, you can use the Pump Serial number to unlock. 13.7 Bluetooth Note The Bluetooth function requires a microSD card to be installed.
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. device (paired, unpaired) will be shown underneath the device name. 2 Machine Name: Choose Machine Name to give your PDA a unique name. Figure 114 3 Visibility: Check the checkbox to allow other Bluetooth devices to detect the PDA. This function will timeout after 120 seconds.
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.
14 Additional Features 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 14.1 Audio Player that delivery has stopped. 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. Note The auto-off feature is disabled by default.
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 Figure 118 instance, if you temporarily do not require any insulin infusion, or need to remove the pump from the infusion set.
Figure 120 Note If a bolus is in progress, you cannot enter Suspend mode. You must first cancel the bolus before suspending delivery. 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.
16 Alarms and Troubleshooting The patch pump system has a 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 comprehensive safety system to check if short period of time, but insulin delivery abnormal situations require immediate continues normally. Users should be attention.
Note You cannot modify the alarm settings, including alarm volume.
16.1 Patch Pump Alarms Alarm Description Priority Level Alarm Signal Solution/Action No Insulin Remaining Medium Vibration There is no more insulin and delivery has stopped. The pump will automatically rewind. Replace the reservoir and check your blood glucose level. Blockage Detected (Occlusion) Medium LED, Vibration Insulin delivery has stopped. Replace the reservoir/infusion set and check your blood glucose level.
16.
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-T2：The 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.
17 Maintenance Your patch pump and PDA are precision instruments. Improper use and maintenance will result in decreased accuracy or even pump failure. Please 17.1.2 PDA 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. read this chapter carefully to learn how to 4 Keep the PDA dry, avoid water.
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. store test strips in heat or direct sunlight. 3 Do not steam sterilize or autoclave your pump or PDA. • Do not store the PDA, test strips, or control solution near bleach or cleaning agents that contain bleach. 17.3 Avoid Immersion in Water • Close the cap on the vial immediately after removing a test strip.
• 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. • Keep the test strip packaging away from children and pets. • Do not transfer test strips from the provided vial into another container. changes in your treatment plan based on your blood glucose test results. • Close the cap on the vial immediately after removing a test strip. • Please refer to the test strip instructions for more detailed information.
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. • Do not use expired control solution. • After cleaning your PDA. Refer to Chapter 10.8 for instructions on how to perform a quality control test. 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.
out at 15-30°C. • 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.
maximize the wireless signal. Avoid obstructions between the PDA and pump, such as walls, floors, metal plates, people, etc. 1 2 Avoid wearing clothing that contains metallic substances around the pump. 3 Avoid strong electromagnetic radiation. 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.
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.
18 Specifications 18.1 General Specifications Patch Pump PDA Model Number MTM-1 MTM-2 Size 59.5x40x11.1mm（LxWxD） 23g（without batter or insulin） 112x57.
18.2 Delivery Attribute Specification Basal Rate 0.025 - 35 U/hr, programmed in increments of 0.025U/hr Basal Programs 3 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 Temporary Basal Rate U/hr or % of basal rate，last 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.
18.4 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 Factor 0.1-16.7 mmol/L/U in 0.1 steps, no default value Negative Correction On/Off, Default is On Active Insulin Time 2-6 hrs in 0.5hr increments，no default value 18.5 Bolus Delivery Bolus Steps Volume per Step 0.05 U 0.5 μL Time Interval Between Steps 1s Infusion Speed per Minute 3U 18.
When the delivery rate was set to 0.01mL/hr, the measured flow is shown in 18.8 Occlusion Alarm Time Figure 123. 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. Typical Time Before Alarm Rate Fast Rate Figure 123 50 sec 53 sec 150 min 160 min 100 hrs 105 hrs (3U/hr) Medium Rate (1U/hr) 18.
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. # Item 1 PDA 1.0m Charge Cable Length （m） Cables Notes Shielded Yes EUT DC 5V The maximum amount of bolus that can be delivered in a single fault is 0.25U. 18.
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 – guidance RF Emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
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. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
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 Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 a IEC 60601 Test Level 3V（Vrms） 150kHz~80MHz 10V（Engineering medical frequency band） 150kHz~80MHz 10 V/m 80MHz~2.
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.
19 Appendix 19.
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.
