IFU-USA-2019-Rev.
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 4.1 Apply Your Transmitter and Patch to be a Sensor 4.2 Check the Glucose Result 4.3 Replace the Patch on the Sensor 4.
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.
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. Do NOT use the equipment in places where aerosol sprays are being used or where oxygen is being administered. 5. Do NOT use under any circumstances the device on neonates or infants. 6.
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. This System can be used in home healthcare and professional healthcare environment. IFU-USA-2019-Rev.
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. Users may place the patch fixed with transmitter on upper arm, and users may continuously get glucose result via transmitter for 24 hours.
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. This product is designed for single person self-monitoring, do not use for one or multiple users to prevent infection risk. 6. When the transmitter or patch pack is opened, it means non-sterile at the while.
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 Touchscreen USB Port Stand by button Receiver 8 IFU-USA-2019-Rev.
1.3 Product and Display Sensor kit: • Transmitter x 1 • Patch x 14 • User Manual x 1 Transmitter top view Transmitter bottom view patch bottom view patch top view IFU-USA-2019-Rev.
Chapter 2 Start to use metaReach® CGMs 2.1 Set Up time 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 “Start” button to go main screen. Press the menu icon can go to the menu screen. 10 IFU-USA-2019-Rev.
2.2 Charging the Receiver Battery Step 1 Action Insert the Receiver Battery Charging Set into receiver charging part properly. While charging, the battery to . symbol will change from IFU-USA-2019-Rev.
Chapter 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 of home screen to mark them. 12 IFU-USA-2019-Rev.
3.2 Functions of Menu Screen Step Action 1 Wake the receiver and go home screen. Press the screen. button to go menu 2 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.
Step Action 3 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. 4 If you want to see the trend of history, please press “Show Plot” to go history screen. 14 IFU-USA-2019-Rev.
Step 5 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. If you do not want sound, please press to be 6 If you want to know all information like receiver/sensor's number, please press “Product Information” to go Information screen.
Step Action 7 If you want to set up date and time, please 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. Caution: If any problem about this product, please contact with local distributors. 16 IFU-USA-2019-Rev.
Chapter 4 Using Your Sensor 4.1 Apply 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 the sensor is assembled well, you can see the flash blue light. IFU-USA-2019-Rev.
Step Action 4 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 18 IFU-USA-2019-Rev.
Step Action Clean your upper arm with alcohol wipe properly and wait for it dry. 5 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 6 Peeling the lid off completely. 7 Place the Sensor over the prepared site and push down firmly to apply the Sensor to your body. When you see the blue light, it means that the sensor is secure. IFU-USA-2019-Rev.
4.2 Check the Glucose Result Step 1 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. When sensor back to the connect range, the data will auto update. 20 IFU-USA-2019-Rev.
4.3 Replace the Patch on the Sensor Step Action 1 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. Caution: the patch will be valid for 1 day, and transmitter can be valid up to 14 days. show 0 day, please change a new transmitter. When show Expire, please change a new patch.
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. 22 IFU-USA-2019-Rev.
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 go logbook screen. IFU-USA-2019-Rev.
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. Ӫ Do not put the receiver under water or any liquid. Ӫ The receiver must be stored at room temperature. Ӫ Wash hands before testing. Ӫ Do not use transmitter and patch that have expired. Check the expiry date printed on the package. Ӫ Immediately use patch and transmitter when you open it.
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. Ӫ IFU-USA-2019-Rev.
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 (R2)=0.79 Test number (n)=94 Test range (mg/dL)=72-213 (mg/dL) Chapter 8 Troubleshooting If you have any issues about metaReach®CGMs, always contact at: service@richhealthtek.
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.
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.
9.3 Adapter Information Supplier: Unifive Technology Model No.: UMB305-0510 Input:AC100-240V, 50/60Hz, 0.16-0.12A Output: DC 5V 1A 9.4 Electromagnetic Compatibility The System needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Ӫ Portable and mobile RF communications equipment can affect the System.
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. Emission test 30 Compliance Electromagnetic environment-guidance (for home and professional healthcare environment) RF emissions CISPR 11 Group 1 The System uses RF energy only for its internal function.
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.
Immunity test Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency(50, 60 Hz) magnetic field IEC 61000-4-8 IEC 60601 test level Compliance level Voltage dips: 0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles Voltage dips: 0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles Voltage interruptions: 0 % UT; 250/300 cycle Voltage interruptions: 0 % UT; 250/300 cycle 30 A/m 50 Hz or 60 Hz 30 A/m 50 Hz NOTE UT is the a.c.
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.
Immunity test Radiated RF IEC 61000-4-3 IEC 60601 test level 10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz Compliance level 10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz Electromagnetic environment-guidance (for home and professional healthcare environment) Recommended separation distance: d = 1,2 √P d = 1,2 √P 80MHz to 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 distan
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.
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 frequency (MHz) Band a) (MHz) Service a) Modulation b) Maximum power (W) Distance (m) IMMUNITY Compliance LEVEL TEST LEVEL (V/m) (V/m) (for home and professional healthcare) 1 720 1 845 1700 –1990 1 970 2 450 2400 –2570 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 5 240 5 500 5 785 5100 –5800 WLAN 802.
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 Ӫ Ӫ 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. This device may not cause harmful interference and 2. This device must accept any interference received, including interference that may cause undesired operation of the device.
-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.
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. Ӫ Do not open the patch or transmitter package until you have washed your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.
Do not use transmitter and patch while bathing or activities which can cause a lot of sweat (ie. swim). Ӫ Do not place patch on exact the same area on the upper arm. Ӫ 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. Ӫ Do not allow young children to hold the sensor or transmitter without adult supervision.
Do not use metaReach®CGMs receiver while charging. It is no function while charging. Ӫ Don’t plug into a computer port to charge. Ӫ Don’t use an external USB hub; it doesn’t provide enough power to charge battery. Ӫ Battery can only be charged using the adapter/wall charger. Ӫ Stop using metaReach®CGMs when malfunctional issues or allergic reactions happen. Ӫ Misuse of the USB cable can present a strangulation risk.
Chapter 11 Events icons information Icons 1 Day Expire 20% What it means What you do The icon shall be in orange color and flashing if the patch’s lifetime is less than 2 hours. Wait till the patch’s lifetime to be expired, or replace with a new patch. 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. The icon shall be in orange color and flashing if the Patch’s lifetime is expired. Replace with a new patch.
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 44 IFU-USA-2019-Rev.
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.
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 46 IFU-USA-2019-Rev.
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