RichHealth metaReach UMB305-0510 User Manual
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RichHealth metaReach UMB305-0510 User Manual

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IFU-USA-2019-Rev.001

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  • Page 1 IFU-USA-2019-Rev.001...
  • Page 2 Chapter 1 About metaReach®CGMs 1.1 Indications for Use 1.2 List of Kit Contents 1.3 Product and Display Chapter 2 Start to use metaReach® CGMs 2.1 Set Up for First Time Use 2.2 Charging the Receiver Battery Chapter 3 Functions of Home and Menu Screen 3.1 Functions of Home Screen 3.2 Functions of Menu Screen Chapter 4 Using Your Sensor...
  • Page 3 Chapter 8 Troubleshooting Chapter 9 System Specification 9.1 Receiver Specifications 9.2 Sensor Specifications 9.3 Adapter Information 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 9.5.3 FCC RF Radiation Exposure Statement Chapter 10 Cautions, Contraindications and Warning Chapter 11 Events icons information...

  • Page 4: Read Before Use

    IMPORTANT SAFETY PRECAUTIONS READ BEFORE USE 1. Use this device ONLY for the intended use described in this manual. 2. Do NOT use accessories which are not specified by the manufacturer. 3. Do NOT use the device if it is not working properly or if it is damaged. 4.
  • Page 5 10. Do not use this reader near cellular or cordless telephones, walkie 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 meter. 11.

  • Page 6: Chapter 1 About Metareach® Cgms

    Chapter 1 About metaReach® CGMs 1.1 Indications for Use The metaReach®CGMs is indicated for measuring interstitial fluid glucose levels intended users /patients (age 18 and older) with diabetes mellitus. The Patient is an intended operator. This product composed of three elements which are patch(with 1 mm long microneedle), receiver and transmitter.
  • Page 7 3. Severe dehydration and excessive water loss may affect the results. If you are under dehydration risk, please contact with your healthcare professionals immediately. 4. Before using the metaReach®CGMs, please wash your hand with soapy water. Rinse and dry properly. 5.
  • Page 8 1.2 List of Kit Contents The System Components 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 　 • User Manual x 1 x 1 •...
  • Page 9 1.3 Product and Display Sensor kit: • Transmitter x 1 　 • Patch x 14 　 • User Manual x 1 Transmitter top view patch bottom view Transmitter bottom view patch top view IFU-USA-2019-Rev.001...

  • Page 10: Chapter 2 Start To Use Metareach® Cgms

    Chapter 2 Start to use metaReach® CGMs 2.1 Set Up time for First Time Use Step Action Press the “Stand by” button to wake up the receiver, and set up the “Date and Time”. Screen will show “Start” button after the “Date and Time” set up completed, and press “Start”...
  • Page 11 2.2 Charging the Receiver Battery Step Action Insert the Receiver Battery Charging Set into receiver charging part properly. While charging, the battery symbol will change from IFU-USA-2019-Rev.001...

  • Page 12: Chapter 3 Functions Of Home And Menu Screen

    Chapter 3 Functions of Home and Menu Screen 3.1 Functions of Home Screen Step Action Wake the receiver and go home screen. If you will like to make notes about Food/Excersie/Insulin, you may go next page of home screen to mark them. IFU-USA-2019-Rev.001...
  • Page 13 3.2 Functions of Menu Screen Step Action Wake the receiver and go home screen. Press the button to go menu screen. If you apply sensor, please press the “Sensor Pairing” to pair with new sensor. More details please refer to 5.1 Pairing with the Sensor. IFU-USA-2019-Rev.001...
  • Page 14 Step Action If you want to calibrate this 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. If you want to see the trend of history, please press “Show Plot” to go history screen.
  • Page 15 Step Action If you want to set up the target glucose range, please press “Target Range” to go range screen to set up the data. Caution: 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.
  • Page 16 Step Action f you want to set up date and time, please press the “Date/Time Setting” to go setting screen. 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. Caution: If any problem about this product, please contact with local distributors.

  • Page 17: Chapter 4 Using Your Sensor

    Chapter 4 Using Your Sensor 4.1 Apply Your Transmitter and Patch to be a Sensor Step Action Take out the patch and transmitter. To assemble the patch and transmitter, line up the column of them. Press the surrounding of the sensor. When the sensor is assembled well, you can see the flash blue light.
  • Page 18 Step Action Pairing with the 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 Home screen. Wireless connecting may take a few seconds IFU-USA-2019-Rev.001...
  • Page 19 Step Action Clean your upper arm with alcohol wipe properly and wait for it dry. Caution: the 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 Peeling the lid off completely.
  • Page 20 4.2 Check the Glucose Result Step Action Check the Glucose 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 automatically storage.
  • Page 21 4.3 Replace the Patch on the Sensor Step Action Replace the Patch on the Sensor Pull up the edge of the adhesive that keeps your Sensor 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.
  • Page 22 4.4 Turn off the Receiver Step Action Turn off the Receiver Press the “Stand by” button about 7 seconds to turn off the Receiver. IFU-USA-2019-Rev.001...

  • Page 23: Chapter 5 Review You Glucose History

    Chapter 5 Review You Glucose History 5.1 Review the Trend of Your Glucose History Step Action Wake the receiver and go home screen. Press the button to go trend screen. Press the button to go logbook screen. IFU-USA-2019-Rev.001...

  • Page 24: Chapter 6 Caring For Your Receiver And Sensor

    Chapter 6 Caring for Your Receiver and Sensor 6.1 Maintenance and Cleaning of Your Receiver and Sensor If the receiver or transmitter surface get dirty, gently wipe with a cloth slightly dampened or use a alcohol wipe. Do not put the receiver under water or any liquid. The receiver must be stored at room temperature.
  • Page 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 to body fluids. IFU-USA-2019-Rev.001...

  • Page 26: Chapter 7 Performance

    Chapter 7 Performance 7.1 Performance The accuracy of the metaReach®CGMs was assessed by comparing blood glucose results obtained 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 (R )=0.79 Test number (n)=94 Test range (mg/dL)=72-213 (mg/dL)

  • Page 27: Chapter 9 System Specification

    Chapter 9 System Specification 9.1 Receiver Specifications Receiver Product No. WN-1A1-0021-01 Glucose assay range: 40 to 400 mg/dL Receiver size: Length: 4.2 inches, Width: 2.5 inches, Thickness: 0.55 inches Receiver weight: 100 grams Receiver power source: One rechargeable battery (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...
  • Page 28 9.2 Sensor Specifications Transmitter product no. WN-1A1-0042-11, Patch product no. WN-1A1-0032-11 Sensor glucose reading range: 40 to 400 mg/dL Sensor size: 8.15 mm height and 26.1 mm diameter Sensor weight: 6 grams Sensor power 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 °C...
  • Page 29 Portable and mobile RF communications equipment can affect the System. The use of accessories, transducers and cables other than those specified by RichHealth Technology Corporation may result in increased EMISSIONS or decreased IMMUNITY of the System. The System should not be used adjacent to or stacked with other equipment...
  • Page 30 Manufacturer’s declaration-electromagnetic emissions The System is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the System should assure that it is used in such an environment. Electromagnetic environment-guidance Emission test Compliance (for home and professional healthcare environment)
  • Page 31 Manufacturer’s declaration-electromagnetic emissions The System is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the System should assure that it is used in such an environment. Electromagnetic environment-guidance IEC 60601 Compliance (for home and professional healthcare...
  • Page 32 Electromagnetic environment-guidance IEC 60601 Compliance Immunity test (for home and professional healthcare test level level environment) Voltage Dips, short Voltage dips: Voltage dips: Mains power quality should be that of a interruptions and 0 % UT; 0,5 cycle 0 % UT; 0,5 cycle typical home healthcare environment.
  • Page 33 Manufacturer’s declaration-electromagnetic emissions The System is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the System should assure that it is used in such an environment. Electromagnetic environment-guidance IEC 60601 Compliance (for home and professional healthcare...
  • Page 34 Electromagnetic environment-guidance IEC 60601 Compliance Immunity test (for home and professional healthcare test level level environment) Radiated RF 10 V/m 10 V/m Recommended separation distance: IEC 61000-4-3 80 MHz – 2,7 GHz 80 MHz – 2,7 GHz d = 1,2 √P 80 % AM at 1 kHz 80 % AM at 1 kHz d = 1,2 √P 80MHz to 800 MHz...
  • Page 35 Recommended separation distance between portable and mobile RF communications equipment and the System The System is intended for use in an electromagnetic environment (for home and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System as recommended below, according to the maximum output power of the communications equipment.
  • Page 36 Manufacturer’s declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The System is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the System should assure that it is used in such an environment. Test Band Service...
  • Page 37 Test Band Service Modulation Maximum Distance IMMUNITY Compliance LEVEL frequency (MHz) power TEST LEVEL (V/m) (MHz) (V/m) (for home and professional healthcare) GSM 1800; 1 720 CDMA 1900; Pulse GSM 1900; 1700 –1990 modulation 1 845 DECT; 217 Hz LTE Band 1, 3, 1 970 4, 25;...
  • Page 38 9.5 Federal Communications Commission (FCC) Requirements 9.5.1 The metaReach®CGMs covered by this user manual are under FCC ID: Transmitter: 2AR59-A01-RH0000001 Receiver: 2AR59-B01-RH0000001 9.5.2 FCC Statement 15.19 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1.
  • Page 39 -Reorient or relocate the receiving antenna. -Increase the separation between the equipment and receiver. -Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -Consult 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 other antenna or transmitter.

  • Page 40: Chapter 10 Cautions, Contraindications And Warning

    Chapter 10 Cautions, Contraindications and Warning CAUTIONS Do not use the metaReach®CGMs if its sterile package has been damaged or opened. Using a non-sterile patch or transmitter might cause infection. Do not open the patch or transmitter package until you have washed your hands with soap and water, and let them dry.
  • Page 41 Do not use transmitter and patch while bathing or activities which can cause a lot of sweat (ie. swim). Do not place patch on exact the same area on the upper arm. CONTRAINDICATIONS and WARNING Do not wear the metaReach®CGMs (patch, transmitter, and receiver) during Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
  • Page 42 Do not use metaReach®CGMs receiver while charging. It is no function while charging. Don’t plug into a computer port to charge. Don’t use an 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 reactions happen.

  • Page 43: Chapter 11 Events Icons Information

    Chapter 11 Events icons information Icons What it means What you do The icon shall be in orange color Wait till the patch’s lifetime to be and flashing if the patch’s lifetime expired, or replace with a new is less than 2 hours. patch.

  • Page 44: Chapter 12 Symbol Information

    Chapter 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 USE BY DATE SERIAL NUMBER IFU-USA-2019-Rev.001...

  • Page 45: Humidity Limitation

    CATALOGUE NUMBER DO NOT REUSE STERILISED 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 TEMPERATURE LIMIT HUMIDITY LIMITATION NON-IONIZING RADIATION IFU-USA-2019-Rev.001...

  • Page 46: Direct Current

    IP22: Protection Against Insertion of Large Objects and Dripping Water DIRECT CURRENT RichHealth Technology Corporation 4F.-12, No.8, Taiyuan 1st St., Zhubei City, Hsinchu County 30288, Taiwan, R.O.C. http://www.richhealthtek.com IFU-USA-2019-Rev.001...

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