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Equil

TM

Insulin Patch Pump System

103

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 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,
change the pump, or possibly inject insulin
manually to control BG levels.

Low priority alarms

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.

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

Note

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Содержание MTM-I

Страница 1: ...Insulin Patch Pump System MTM I Insulin Patch Pump System User Manual TM...

Страница 2: ......

Страница 3: ...Components 8 3 2 Accessories 8 4 Getting Started 11 4 1 PDA Setup 11 4 2 Charging the Batteries 15 4 3 Settings Wizard 17 4 4 Home Screen 24 4 5 Lock Screen 27 5 Basal Rate Adjustment 29 5 1 Understan...

Страница 4: ...oval 73 10 5 Ejecting Test Strips 75 10 6 Testing Blood Glucose 75 10 7 Comparing Meter and Lab Results 77 10 8 Quality Control Tests 78 10 9 Entering Your Glucose Reading Manually 81 10 10 Settings 8...

Страница 5: ...n 110 17 6 X Ray MRI and CT Scans 112 17 7 Wireless Connection 112 17 8 Precautions 112 17 9 Disposal 113 17 10 Transportation 113 17 11 Storage 113 17 12 Other Considerations 114 18 Speci cations 115...

Страница 6: ...Introduction 2 1 Indications This product is intended for subcutaneous under the skin delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insuli...

Страница 7: ...3 2 3 Contraindications 2 4 Before Use Basal Rate Active Insulin Time 1 2 concentration does not exceed 5 6 mmol L con gured with up to 48 scheduled basal rate changes within one day However if you...

Страница 8: ...ur healthcare professional can help you understand the usage in even greater detail Please read this user guide in the correct order In many cases subsequent sections refer to information detailed in...

Страница 9: ...nsulin for people with diabetes If it is used incorrectly it could cause life threatening situations Before using the pump please read the user guide carefully Patients must be trained by a healthcare...

Страница 10: ...rofessional Please keep the battery charged Do not drop or immerse in water as this could cause a malfunction 2 10 Blood Glucose Test Function Precautions The blood glucose testing function is for in...

Страница 11: ...ral circulation collection of capillary blood from the approved sample sites is not advised as the results might not be a true re ection of the physiological blood glucose level It may apply under the...

Страница 12: ...sistant 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 humidit...

Страница 13: ...ilTM Insulin Patch Pump System 3 Component Descriptions 3 1 Pump System Components 3 2 Accessories Cannula Inserter Personal Diabetes Assistant PDA 1 Patch Pump Battery Contacts Motor System Bolus But...

Страница 14: ...ries and disposables that are manufactured by MicroTech Medical or with the Equil brand name Use of non standard components may a ect safety of the device Warning 4 The included charger can be used in...

Страница 15: ...il Insulin Reservoir Equil Insulin Infusion Set Cannula Insulin Pump Base Microtech Exactive EQ blood glucose test strips Summary of components included with the Equil Insulin Patch Pump System Patch...

Страница 16: ...card Insert memory card into the slot as shown in Figure 5 Figure 5 Finger Hold The microSD memory card must be inserted with the battery removed A microSD card is not provided with your pump package...

Страница 17: ...quilTM Insulin Patch Pump System 3 4 Figure 7 Note Figure 6 Use only batteries and chargers from MicroTech Medical Use of third party accessories may cause unexpected errors and will void your warrant...

Страница 18: ...andby mode Screen On When in standby pressing the power button will switch the display on and present the lock screen Power O If the display is on press and hold the power button to open a dialog box...

Страница 19: ...splay 3 2 color display with touchscreen Charger Data Port Connect the PDA charger to this port to recharge the battery This port can also be used to transfer data to a personal computer using a data...

Страница 20: ...r o during the charging process however the battery will charge faster if the PDA is o 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...

Страница 21: ...nsulin Patch Pump System 4 2 2 Patch Pump Battery Charger 1 Figure 10 2 Figure 11 3 4 Note If the PDA battery charger does not work do not try to repair it Please contact your local supplier for a rep...

Страница 22: ...ate setup screen shown in Figure 13 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 Note A full battery...

Страница 23: ...EquilTM Insulin Patch Pump System Figure 13 Figure 14 Figure 15 box Figure 15 that can be used to input the...

Страница 24: ...sal Settings The second screen in the Settings Wizard shows the basic basal settings Figure 17 Figure 17 a Choose the Maximum Basal Rate setting to open a dialog box Figure 18 that can be used to inpu...

Страница 25: ...EquilTM Insulin Patch Pump System Figure 18 Figure 19 O U hr Note Note This feature is used to limit the maximum amount of basal delivery that can be administered by accident or maloperation...

Страница 26: ...to enter the third Settings Wizard screen or Previous to enter the previous setting screen Basic Bolus Settings The third screen in the Settings Wizard shows the Basic Bolus settings Figure 21 Figure...

Страница 27: ...EquilTM Insulin Patch Pump System Figure 22 Figure 23 O U Figure 24 Note This feature is used to limit the maximum amount of bolus delivery that can be administered by accident or maloperation...

Страница 28: ...on 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 switched o...

Страница 29: ...that youshould consider lling a new reservoir Use the and buttons to select the appropriate value After you have completed the Settings Wizard you can use all of the basic functions of the pump syste...

Страница 30: ...that is currently connected Alert icon If an alert appears this icon will appear on the status bar Insulin Remaining Shows how much insulin remains by varying degree if PDA wireless link is poor it di...

Страница 31: ...EquilTM Insulin Patch Pump System PDA Battery Level Figure 28 Information Display Area Function Buttons 1 2 Note Press the button in the middle of the Status Bar and it will enlarge as in Figure 28...

Страница 32: ...tings Menu 6 Suspend Resume Pressing this button allows you to quickly suspend or resume insulin delivery 4 5 Lock Screen If you press the power button to switch the display o or the display switches...

Страница 33: ...EquilTM Insulin Patch Pump System Time and Date Display Area Information Display Area Unlock Area Note Note...

Страница 34: ...eady 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 th...

Страница 35: ...tem Browsing Settings Reviewing Basal Programs The Note 1 2 Note Quick Basal Program Setup 3 The Quick Basal Program Setup is only an estimate of your daily basal needs Consult your healthcare profess...

Страница 36: ...d new basal rate The base basal rate was set in the Settings Wizard so by default all 24 hours of the basal program are set to this delivery rate To add a new basal time period press the Change Settin...

Страница 37: ...n Patch Pump System Figure 33 Figure 34 the Press the button to add a new basal time period Figure 33 After editing is complete Figure 34 the basal rate time will automatically be divided into multipl...

Страница 38: ...te the Basal Program graph display as shown in Figure 36 If you press the Back button while in the Basal Edit screen a dialog box will open to con rm that you would like to exit Choose OK to discard y...

Страница 39: ...EquilTM Insulin Patch Pump System Figure 36 Reviewing Basal Programs Add a Basal Time Period Figure 37 then 1 2 Note...

Страница 40: ...y Basal Rate see Section 5 6 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 Choos...

Страница 41: ...Figure 38 Figure 39 Note Note A temporary basal rate should be determined under guidance from your healthcare professional The Rate can either be set in U hr or by of the current basal rate For more i...

Страница 42: ...ates a O Switch o 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 b...

Страница 43: ...have elevated blood glucose levels after meals requiring bolus doses of insulin to lower blood glucose levels A bolus refers to the amount of insulin that is quickly infused before a meal Carbohydrat...

Страница 44: ...ll be green and you can choose the Start button to begin to administer the bolus A window will open for you to con rm that you want to send the bolus Your last bolus amount and time will be shown as a...

Страница 45: ...EquilTM Insulin Patch Pump System Figure 45 1 Figure 46 2 47...

Страница 46: ...w can be useful when you eat meals with both rapidly and slowly absorbed carbohydrates including meals with a high fat content such as some fast foods An Extended Bolus With Amount Now is a bolus that...

Страница 47: ...n 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 Amount Now The bolus amount to be administered immediately Extend amo...

Страница 48: ...Figure 50 6 4 2 Extended Bolus Without Amount Now An Extended Bolus Without Amount Now can be useful when you have eaten a meal over a prolonged period of time with extended snacking have delayed dig...

Страница 49: ...EquilTM Insulin Patch Pump System 6 5 Quick Bolus The Equil Insulin Patch Pump System has 6 5 1 Quick Bolus Using the PDA 1 Figure 51 2 Note...

Страница 50: ...he bolus correctly you will hear a con rmation 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 Pu...

Страница 51: ...EquilTM Insulin Patch Pump System 3 6 6 Canceling a Bolus Note Note Note Note will repeat the audible tones back to you...

Страница 52: ...n pressing the or button 3 Maximum Bolus Setting This is the maximum bolus that the user can choose in the bolus menu 4 Extended Bolus Settings a OFF Extended bolus function is o and corresponding but...

Страница 53: ...k 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 bolusincreases with every Quick...

Страница 54: ...on 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 Note Firstly wash your hands Then use an alcohol...

Страница 55: ...s shown in Figure 56 Press down until you hear a click securing it in place Press the release button on both sides of the cannula inserter at the same time then the cannula will be inserted into the b...

Страница 56: ...pose of the insertion needle properly in a medical sharps container Note Release the inserter from the pump base by pressing the button on the lower end of the cannula inserter as shown in Figure 57 I...

Страница 57: ...Figure 60 3 Figure 61 4 Figure 62 Use an alcohol wipe to clean the insulin vial or cartridge and then attach it to the ll adapter as in Figure 60 With the insulin vial or cartridge on top slowly pull...

Страница 58: ...e reservoir Repeat until the reservoir has enough insulin and there are no visible air bubbles Figure 63 Figure 63 6 Remove the insulin vial or cartridge from the ll adapter Figure 64 Figure 64 7 Pull...

Страница 59: ...EquilTM Insulin Patch Pump System 8 Figure 66 7 4 Assembling Reservoir to Pump Figure 67 illustrates the sequence to...

Страница 60: ...shown in Figure 69 bend the assembly along the seam line as shown until the reservoir separates from the pump Be sure to recharge the battery immediately to make sure that a fresh battery is always i...

Страница 61: ...ch Pump 1 Warning to connect your pump the wizard will start with Figure 70 Apply a new infusion set Section 7 1 assemble a lled reservoir and a charged battery Section 7 3 and 7 4 to the pump as show...

Страница 62: ...EquilTM Insulin Patch Pump System 57 Figure 70...

Страница 63: ...infusion set Section 7 2 apply a new one Section 7 1 and press Continue The next page will prompt you to deactivate your old pump Figure 72 Press Continue to disconnect the old pump from the PDA and...

Страница 64: ...e 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 For safety reasons th...

Страница 65: ...EquilTM Insulin Patch Pump System Figure 73 3 Figure 74 4 XXXXXX...

Страница 66: ...EquilTM Insulin Patch Pump System 61 Figure 75 Figure 76 5 Connect the pump to the infusion set as shown in Figure 77 and press Continue Needle Tip...

Страница 67: ...EquilTM Insulin Patch Pump System Figure 77 6 Note...

Страница 68: ...EquilTM Insulin Patch Pump System 63 Figure 78...

Страница 69: ...ations such as installing removing an infusion set lling a new reservoir and assembling disassembling the reservoir Section 7 If the insulin reservoir connected to your pump is empty you should replac...

Страница 70: ...y may require you to change reservoirs more frequently resulting in wasted insulin Note Separate the used reservoir from the pump Section 7 5 dispose of the old reservoir and then assemble a lled rese...

Страница 71: ...EquilTM Insulin Patch Pump System...

Страница 72: ...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 82 The background of the Next button will b...

Страница 73: ...EquilTM Insulin Patch Pump System 4...

Страница 74: ...ystem 69 Figure 83 5 Now choose whether or not to prime the cannula Figure 84 Upon completion the pump will begin to deliver Figure 84 Skip only if the infusion set was not replaced and thus cannula d...

Страница 75: ...if necessary Dry your hands and the sampling site ensuring that there is no soap residue remaining It is used to determine blood glucose concentrations in fresh capillary whole blood It can be used fo...

Страница 76: ...cing device cap Insert the lancet into the lancet holder until it comes to a complete stop as indicated in Figure 86 Figure 86 2 Twist o the safety cap from the lancet Figure 87 and save the safety ca...

Страница 77: ...e the lowest setting that still produces an adequeate blood sample Pull back the cocking barrel Figure 90 until you hear a click Now the lancing device is loaded and ready to draw blood Before taking...

Страница 78: ...wly from the base of your nger to the tip to increase the sample size Figure 92 Figure 92 10 4 Lancet Removal 1 Unscrew the lancing device cap Firmly push the needle into the safety cap as shown in Fi...

Страница 79: ...ns Reminder holder and dispose of the lancet in a sharps container Figure 94 Clean your lancing device before and after use with an alcohol wipe or a disinfectant wipe Be sure to clean the part of the...

Страница 80: ...ou can easily eject the test strip by sliding the ejector button as shown in Figure 95 Figure 95 10 6 Testing Blood Glucose If the display is on insert an Exactive EQ test strip and the blood glucose...

Страница 81: ...id Measurement Box Bolus Calculator Menu the button will 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 s...

Страница 82: ...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 You...

Страница 83: ...ge allowed by local goverment appear Check the control solution check box to indicate that you are doing a quality control test The PDA will display an animation as in Figure 99 Shake the control solu...

Страница 84: ...e 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 proper...

Страница 85: ...EquilTM Insulin Patch Pump System Figure 100 3 Note...

Страница 86: ...so 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 From...

Страница 87: ...EquilTM Insulin Patch Pump System Figure 101 10 10 Settings Figure 102...

Страница 88: ...en and your new BG reminder will appear Now you can enable disable the reminder by checking unchecking the box Figure 104 Figure 104 If you would like for this reminder to repeat every day click the c...

Страница 89: ...EquilTM Insulin Patch Pump System 10 11 Blood Glucose Meter Troubleshooting Note BG Alert Message Message Type Solution the test m...

Страница 90: ...d glucose level user setting con rmed by your healthcare professional 3 Carbohydrate ratio con rmed by your healthcare professional 4 Carbohydrate intake user input 5 Insulin sensitivity factor con rm...

Страница 91: ...culator 1 Note Note Note Section 11 3 Active Insulin Insulin is normally absorbed in the body within about 4 6 hours If you have recently taken a bolus there could still be active insulin in your body...

Страница 92: ...at Figure 106 and press OK to move to the next step Figure 106 If you are not eating the bolus calculator will not take into account carbohydrates that you will eat Note Note Figure 105 You can estima...

Страница 93: ...xt page is the suggested bolus screen Figure 107 At the top of the screen is the suggested bolus size the middle of the screen contains the calculation parameters and the bottom of the screen are acti...

Страница 94: ...ase discuss this with your healthcare professional before using this function Note Your blood glucose reading is only valid for 10 minutes If you do not issue a bolus within 10 minutes of your test pl...

Страница 95: ...lin Patch Pump System Insulin Sensitivity Factor ISF Negative Correction Active Insulin Time Note 4 3 5 Since everyones values are di erent choose your settings under the guidance of your healthcare p...

Страница 96: ...f 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 Figure 108 Press the date near the top of the scre...

Страница 97: ...entries such as BG readings changes in Basal Rate and Bolus amounts You can use your nger to scroll up and down through the list You may also lter the results by using the check boxes beneath the list...

Страница 98: ...trait 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 o...

Страница 99: ...the very top of the screen you can change the week by pressing the The left side of the screen shows the time while the top of the screen shows the day You can scroll through and tap di erent time per...

Страница 100: ...tings 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 ho...

Страница 101: ...are version PDA Serial Number Pump Serial Number 13 3 Language 13 4 Memory Card Total Space Available Space History Export 13 5 Display Brightness Screen Timeout 1 1 2 2 3 1 2 3 time that it takes the...

Страница 102: ...you forget your password you can use the Pump Serial number to unlock Change Password Use to reset the password Restore Factory Settings All settings reset to the factory defaults 13 7 Bluetooth From...

Страница 103: ...5 to switch the Bluetooth on The Bluetooth logo will appear in the status bar More options will appear if Bluetooth is on Using the devices on the list the PDA has the following Bluetooth options If a...

Страница 104: ...he code and accept to pair a new device Figure 116 Figure 116 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...

Страница 105: ...EquilTM Insulin Patch Pump System 14 Additional Features 14 1 Audio Player 14 2 Auto O 14 3 Food Database Note switched on...

Страница 106: ...A con rmation 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 pri...

Страница 107: ...EquilTM Insulin Patch Pump System Figure 119 Figure 120 Note...

Страница 108: ...rms as de ned 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 change the pump...

Страница 109: ...ump System PDAAlarmPriorityLevels Patch Pump Alarm Priority Levels Audio Alarm Volume Alarm Level Visual Signal Audio Signal Alarm Level Visual Signal Audio Signal Vibration Signal Device Sound Pressu...

Страница 110: ...ulin 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 Pleas...

Страница 111: ...ntact your supplier for a replacement 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 mo...

Страница 112: ...ime it takes for the pump to send the alarm information wirelessly to the PDA 4s T5 T4 The amount of time between when the PDA receives the alarm to issuing the alarm signal 0 1s Figure 121 GraphicalR...

Страница 113: ...TM Insulin Patch Pump System 17 Maintenance 17 1 Cleaning 17 1 1 Pump 1 2 3 4 5 17 1 2 PDA 1 2 3 4 5 6 17 1 3 Lancing Device 17 2 Avoid Extreme Temperatures 1 2 read this section carefully to learn ho...

Страница 114: ...with the PDA Store test strips in a clean dry environment at 5 30 41 86 Do not store test strips in heat or direct sunlight Do not refrigerate or freeze test strips Do not store or use strips in a hum...

Страница 115: ...ths after rst being opened Please take note of the date that the vial was rst opened and discard after 6 months removing it from the package otherwise the test results may not be accurate professional...

Страница 116: ...e until it has warmed to room temperature Do not use expired control solution Control solution may be used for 6 months after the bottle is opened for the rst time Please take note of the date that th...

Страница 117: ...EquilTM Insulin Patch Pump System 17 6 X Ray MRI and CT Scans 17 7 Precautions 17 8 Wireless Connection...

Страница 118: ...atus 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 17 9 Disposal When you replace the pump PDA and its attachments please do n...

Страница 119: ...EquilTM Insulin Patch Pump System 17 11 Storage 17 12 Other Considerations...

Страница 120: ...ated Power Warranty MTM 1 59 5x40x11 1mm LxWxD 23g without batter or insulin 2ml 5 40 41 104 10 93 noncondensing 40 55 5 95 noncondensing IPX4 LED Yellow Vibration Automatically Syncs to PDA None 70mA...

Страница 121: ...EquilTM Insulin Patch Pump System 18 2 Delivery 18 3 Blood Glucose Meter Attribute Speci cation Attribute Speci cation Test time...

Страница 122: ...sion Speed per Minute 0 05 U 0 5 L 1s 3 U The above test results were achieved using pump serial number 0A001 and reservoir batch number G13B25001 Note Attribute Speci cation On O default is o 1 150 g...

Страница 123: ...Occlusion Detection Maximum Infusion Pressure 18 8 Occlusion Alarm Time 18 9 Overdose Underdose Rate Typical Time Before Alarm Maximum Time Before Alarm The Table below shows two delivery The pump co...

Страница 124: ...he cables and accessories provided The cable information is as follows The use of accessories other than those speci ed for the device is not recommended They may result in increased emissions or decr...

Страница 125: ...EquilTM Insulin Patch Pump System Guidanceandmanufacturer sdeclaration electromagneticimmunity Emissions Test Compliance Electromagnetic environment guidance I...

Страница 126: ...or 25 cycles 5 Ut 95 dip in Ut for 5 s 3 A m 8 kV Contact 15kVAir 2 kV 1 kV for input output lines 1 kV Di erential mode 2 kV Common mode 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycle...

Страница 127: ...EquilTM Insulin Patch Pump System Guidanceandmanufacturer sdeclaration electromagneticimmunity P a b Immunity Test IEC 60601 Compliance Electromagnetic environment guidance Test Level Level a b...

Страница 128: ...ons equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment For transmitters rated at a maximum output power not listed above t...

Страница 129: ...EquilTM Insulin Patch Pump System 19 Appendix 19 1 Symbols LOT SN IVD CTRL STERILE EO IPX4...

Страница 130: ...Website https www homemed co za EC REP Lotus Global Co Ltd 1 Four Seasons Terrace West Drayton Middlesex London UB7 9GG United Kingdom MicroTech Medical Hangzhou Co Ltd Address No 9 Haishu Road Yuhang...

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