RichHealth metaReach UMB305-0510 User Manual Download

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IFU-USA-2019-Rev.001

Summary of Contents for metaReach UMB305-0510

Page 1: ...IFU USA 2019 Rev 001...

Page 2: ...een 3 1 Functions of Home Screen 3 2 Functions of Menu Screen Chapter 4 Using Your Sensor 4 1 Apply Your Transmitter and Patch to be a Sensor 4 2 Check the Glucose Result 4 3 Replace the Patch on the...

Page 3: ...formation 9 4 Electromagnetic Compatibility 9 5 Federal Communications Commission FCC Requirements following 9 5 1 The metaReach CGMs covered by this user manual are under FCC ID 9 5 2 FCC Statement 9...

Page 4: ...y symptoms or diseases The data measured is for reference only User should not take any decision of medical relevance without first consultation of medical practitioner Always consult your doctor to h...

Page 5: ...lkie talkies garage door openers radio transmitter or other electrical or electronic equipment that are sources of electromagnetic radiation as these may interfere with the proper operation of the met...

Page 6: ...on upper arm and users may continuously get glucose result via transmitter for 24 hours The metaReach CGMs detection range is defined as 40 400 mg dL Cautions Contact your healthcare professional if t...

Page 7: ...ers to prevent infection risk 6 When the transmitter or patch pack is opened it means non sterile at the while Please use it immediately do not put back for storage And also this is single use product...

Page 8: ...onents is comprised of five key parts receiver transmitter patch USB charging cable and adapter in two kits Receiver kit and Sensor kit Receiver kit Receiver x 1 Adapter x 1 USB charging cable x 1 Use...

Page 9: ...IFU USA 2019 Rev 001 9 1 3 Product and Display Sensor kit Transmitter x 1 Patch x 14 User Manual x 1 Transmitter bottom view Transmitter top view patch bottom view patch top view...

Page 10: ...me for First Time Use Step Action 1 Press the Stand by button to wake up the receiver and set up the Date and Time 2 Screen will show Start button after the Date and Time set up completed and press St...

Page 11: ...U USA 2019 Rev 001 11 2 2 Charging the Receiver Battery Step Action 1 Insert the Receiver Battery Charging Set into receiver charging part properly While charging the battery symbol will change from t...

Page 12: ...er 3 Functions of Home and Menu Screen 3 1 Functions of Home Screen Step Action 1 Wake the receiver and go home screen 2 If you will like to make notes about Food Excersie Insulin you may go next page...

Page 13: ...of Menu Screen Step Action 1 Wake the receiver and go home screen Press the button to go menu screen 2 If you apply sensor please press the Sensor Pairing to pair with new sensor More details please...

Page 14: ...his system please press Calibration to go calibration screen to set up the data Caution take a fingerstick blood glucose measurement with your blood glucose meter for calibration 4 If you want to see...

Page 15: ...n consult your paramedics before setting up the target glucose range Caution if your result is higher or lower than the range there will be sound and home screen flashing to remind you If you do not w...

Page 16: ...press the Date Time Setting to go setting screen 8 If you want to clean all data please press Reset to go reset screen Caution be careful about this function it will clean all data and be Irreversible...

Page 17: ...Your Transmitter and Patch to be a Sensor Step Action 1 Take out the patch and transmitter 2 To assemble the patch and transmitter line up the column of them Press the surrounding of the sensor 3 When...

Page 18: ...Sensor Open the Sensor Pairing page and press the Wireless function in menu screen Choose the collect sensor press Pair and then OK to complete pairing And also press the Stand by button to go back to...

Page 19: ...area that patch will be paste must be clean and dry otherwise it may affect the result and sensor may not stick to the site 6 Peeling the lid off completely 7 Place the Sensor over the prepared site...

Page 20: ...Result Wake up the receiver and go home screen The result will automatically show on the home screen Caution if the sensor is far away from receiver 6m the data can not update immediately and will au...

Page 21: ...ensor attached to your skin Slowly peel away from your skin in one motion Note Any remaining adhesive residue on the skin can be removed with warm soapy water or isopropyl alcohol Caution the patch wi...

Page 22: ...22 IFU USA 2019 Rev 001 4 4 Turn off the Receiver Step Action 1 Turn off the Receiver Press the Stand by button about 7 seconds to turn off the Receiver...

Page 23: ...001 23 Chapter 5 Review You Glucose History 5 1 Review the Trend of Your Glucose History Step Action 1 Wake the receiver and go home screen 2 Press the button to go trend screen 3 Press the button to...

Page 24: ...d Check the expiry date printed on the package Immediately use patch and transmitter when you open it Please storage the patch and transmitter between 4 30 C and dry place Do not refrigerate the patch...

Page 25: ...v 001 25 6 2 Disposal This product should be disposed of in accordance with all applicable local regulations related to the disposal of electronic equipment batteries and materials potentially exposed...

Page 26: ...ained by patients with those obtained using clinical analyzer The following results were obtained by 94 test numbers Slope 0 8 y intercept mg dL 24 7 mg dL Correlation Coefficient R2 0 79 Test number...

Page 27: ...tery 3V 4 2V Receiver battery life 4 days of typical use Receiver memory 30 days of typical use Receiver operating temperature 10 C to 40 C Receiver storage temperature 20 C to 60 C Operating and stor...

Page 28: ...r source One Manganese Dioxide Li Organic Electrolyte 2 2V 3 3V not replaceable Sensor life Up to 7 days Sensor memory 9 hours glucose readings stored every 5 minutes Operating temperature 10 C to 40...

Page 29: ...mation provided in this manual Portable and mobile RF communications equipment can affect the System The use of accessories transducers and cables other than those specified by RichHealth Technology C...

Page 30: ...healthcare environment RF emissions CISPR 11 Group 1 The System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in n...

Page 31: ...ge ESD IEC 61000 4 2 Contact 8 kV Air 2 kV 4 kV 8 kV 15 kV Contact 8 kV Air 2 kV 4 kV 8 kV 15 kV Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relati...

Page 32: ...30 cycles Voltage interruptions 0 UT 250 300 cycle Mains power quality should be that of a typical home healthcare environment If the user of the System requires continued operation during power mains...

Page 33: ...romagnetic environment guidance for home and professional healthcare environment Conducted RF IEC 61000 4 6 3Vrms 0 15 MHz 80 MHz 6Vrms in ISM and amateur radio bands between 0 15 MHz and 80 MHz 80 AM...

Page 34: ...o 800 MHz d 2 3 P 800MHz to 2 7 GHz 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 m...

Page 35: ...of transmitter W Separation distance according to frequency of transmitter 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1...

Page 36: ...hould assure that it is used in such an environment Test frequency MHz Band a MHz Service a Modulation b Maximum power W Distance m IMMUNITY TEST LEVEL V m Compliance LEVEL V m for home and profession...

Page 37: ...Hz 2 0 3 28 28 5 240 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 9 5 500 5 785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL the distance between the transmitting antenna and...

Page 38: ...d void the user s authority to operate the equipment 15 105 b 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...

Page 39: ...connected Consult the dealer or an experienced radio TV technician for help 9 5 3 FCC RF Radiation Exposure Statement This Transmitter must not be co located or operating in conjunction with any othe...

Page 40: ...until you have cleaned the skin near the insertion site with an alcohol wipe Using patch might cause allergic reaction please consult paramedics before using it Do not discard your transmitter It is r...

Page 41: ...s that may pose a choking hazard Immediately use patch and transmitter when you open it Please storage the patch and transmitter between 4 30 C and dry place If the sensor is far away from receiver 6...

Page 42: ...n external USB hub it doesn t provide enough power to charge battery Battery can only be charged using the adapter wall charger Stop using metaReach CGMs when malfunctional issues or allergic reaction...

Page 43: ...new patch 1 Day The color of the indicator shall be in orange and flashing if the transmitter lifetime is less than 1 day Replace with a new transmitter Expire The icon shall be in orange color and f...

Page 44: ...pter 12 Symbol Information Symbol Title MANUFACTURER EC REP AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY CE MARK CONSULT INSTRUCTIONS FOR USE CAUTION KEEP AWAY FROM SUNLIGHT KEEP DRY BATCH CODE...

Page 45: ...RILISED USING IRRADIATION STERILISED USING E O TYPE BF APPLIED PART THE WEEE SYMBOL SEPARATE COLLECTION FOR ELECTRICAL AND ELECTRONIC EQUIPMENT DO NOT USE IF PACKAGE IS DAMAGED DATE OF MANUFACTURE TEM...

Page 46: ...01 RichHealth Technology Corporation 4F 12 No 8 Taiyuan 1st St Zhubei City Hsinchu County 30288 Taiwan R O C http www richhealthtek com IP22 Protection Against Insertion of Large Objects and Dripping...

Page 47: ...NCC 1...

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RichHealth metaReach UMB305-0510, User Manual

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