IFU-USA-2019-Rev.001 Chapter 1 About metaReachCGMs Indications for Use 1.1 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 4.4 Turn off the Receiver Chapter 5 Review You Glucose History 5.1 Review the Trend of Your Glucose History Chapter 6 Caring for Your Receiver and Sensor 6.1 Maintenance and Cleaning of Your Receiver and Sensor 6.2 Disposal Chapter 7 Performance 7.1 Performance 2 IFU-USA-2019-Rev.001 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 metaReachCGMs 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 Chapter 12 Symbol Information C o n t e n t IFU-USA-2019-Rev.001 3 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. This device does NOT serve as a cure for any 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 have the results interpreted. 7. Before using this device to test glucose, read all instructions thoroughly and practice the test. Carry out all the quality control checks as directed. 8. Use this instrument in a dry environment, if synthetic materials are present
(synthetic clothing, carpets etc.) it may cause damaging static discharges that may cause erroneous results. 9. Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation. 4 IFU-USA-2019-Rev.001 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.001 5 Chapter 1 About metaReach CGMs 1.1 Indications for Use The metaReachCGMs 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. The metaReachCGMs detection range is defined as 40 ~ 400 mg/dL. Cautions:
Contact your healthcare professional, if the following issue cannot be resolved:
1. The result of this product is only for self-monitoring reference not for diagnosis; do not change the therapy according to metaReachCGMs test result without consulting healthcare professional. 2. If the glucose result does not match your feelings, please apply a finger blood glucose testing to confirm. If this issue remains, please remove old patch and replace a set of new one. 6 IFU-USA-2019-Rev.001 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 metaReachCGMs, 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. Please use it immediately, do not put back for storage. And also, this is single use product, please dispose it after use. 7. The metaReachCGMs small part and batteries could be harmful for children, and please storage it properly and away from children. 8. Some people's skin maybe sensitive or allergy of patch; please remove the patch and contact your healthcare professionals once the discomfort opens immediately. Please read this manual carefully before use this product. IFU-USA-2019-Rev.001 7 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 Touchscreen USB Port Stand by button 8 IFU-USA-2019-Rev.001 Receiver 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 9 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. 1 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 10 IFU-USA-2019-Rev.001 can go to the menu screen. 2.2 Charging the Receiver Battery Step 1 Action Insert the Receiver Battery Charging Set into receiver charging part properly. While charging, the battery symbol will change from to
. IFU-USA-2019-Rev.001 11 Chapter 3 Functions of Home and Menu Screen 3.1 Functions of Home Screen Step Action Wake the receiver and go home screen. 1 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.001 3.2 Functions of Menu Screen Step Action 1 2 Wake the receiver and go home screen. Press the screen. button to go menu 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 13 Step Action 3 4 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. 14 IFU-USA-2019-Rev.001 Step Action 5 6 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 If you want to know all information like receiver/sensor's number, please press Product Information to go Information screen. IFU-USA-2019-Rev.001 15 Step Action 7 8 If 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. 16 IFU-USA-2019-Rev.001 Chapter 4 Using Your Sensor 4.1 Apply Your Transmitter and Patch to be a Sensor Step Action 1 2 3 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. IFU-USA-2019-Rev.001 17 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.001 Step Action 5 6 7 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. 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.001 19 4.2 Check the Glucose Result Step Action 1 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.001 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. When When show 0 day, please change a new transmitter. show Expire, please change a new patch. IFU-USA-2019-Rev.001 21 4.4 Turn off the Receiver Step 1 Action Turn off the Receiver Press the Stand by button about 7 seconds to turn off the Receiver. 22 IFU-USA-2019-Rev.001 Chapter 5 Review You Glucose History 5.1 Review the Trend of Your Glucose History Step Action Wake the receiver and go home screen. 1 2 3 Press the button to go trend screen. Press the button to go logbook screen. IFU-USA-2019-Rev.001 23 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.
Wash hands before testing.
Do not use transmitter and patch that have expired. Check the expiry date printed on the package.
Immediately use patch and transmitter when you open it.
Please storage the patch and transmitter between 4-30C and dry place.
Do not refrigerate the patch and transmitter.
Use only metaReachCGMs supplied parts (including cables and chargers)
Unauthorized actions may put you at risk, cause the metaReachCGMs to malfunction.
Do not replace any applied parts from metaReachCGMs kit including adapter and cable. The metaReachCGMs wont work if you mix components from different brands. If you have any issues about metaReachCGMs, always contact at:
service@richhealthtek.com 24 IFU-USA-2019-Rev.001 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 25 Chapter 7 Performance 7.1 Performance The accuracy of the metaReachCGMs 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 metaReachCGMs, always contact at:
service@richhealthtek.com 26 IFU-USA-2019-Rev.001 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 Receiver storage temperature: -20 C to 60 C Operating and storage relative humidity: 10-75%, non-condensing Receiver water resistance: IP22 Receiver moisture protection: Keep dry Operating and storage altitude: 0 to 3,048 meters (10,000 ft) Radio Frequency: 2.402 2.480 GHz Mean service life: 1 years of typical use Power Adapter: Operating temperature: 10 C to 40 C IFU-USA-2019-Rev.001 27 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 DioxideLi/Organic Electrolyte 2.2V3.3V (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 Sensor storage temperature: 4 C to 30 C Operating and storage relative humidity: 10-75%, non-condensing Sensor water resistance: IP22 Operating and storage altitude: 0 to 3,048 meters (10,000 ft) Protection Against Electrical Shock: Type BF applied part 28 IFU-USA-2019-Rev.001 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.
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 and that if adjacent or stacked use is necessary, the System should be observed to verify normal operation in the configuration in which it will be used. IFU-USA-2019-Rev.001 29 Manufacturers 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 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. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations
/flicker emissions IEC 61000-3-3 Compliance 30 IFU-USA-2019-Rev.001 Manufacturers 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 IEC 60601 test level Compliance level Electrostatic discharge(ESD) IEC 61000-4-2 Contact:8 kV Air2 kV,4 kV, 8 kV,15 kV Contact:8 kV Air2 kV,4 kV, 8 kV,15 kV Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5
+ 2kV for power supply lines
+ 1kV for input/
output lines
+ 0.5kV, +1kV line(s) to line(s)
+ 0.5kV, +1kV,+
2kV line(s) to earth
+ 2kV for power supply lines Not applicable
+ 0.5kV, +1kV line(s) to line(s) Not applicable Electromagnetic environment-guidance
(for home and professional healthcare environment) Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Mains power quality should be that of a typical home healthcare environment. Mains power quality should be that of a typical home healthcare environment. IFU-USA-2019-Rev.001 31 Immunity test IEC 60601 test level Compliance level 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 Voltage dips:
0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles Voltage interruptions:
0 % UT; 250/300 cycle Voltage dips:
0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles 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. mains voltage prior to application of the test level. Electromagnetic environment-guidance
(for home and professional healthcare environment) Mains power quality should be that of a typical home healthcare environment. If the user of the System requires continued operation during power mains interruptions, it is recommended that the System be powered from an uninterruptible power supply or a battery. The System power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare environment. 32 IFU-USA-2019-Rev.001 Manufacturers 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 IEC 60601 test level Compliance level Conducted RF IEC 61000-4-6 3 Vrms:
0,15 MHz 80 MHz 6 Vrms:
in ISM and amateur radio bands between 0,15 MHz and 80 MHz 3 Vrms:
0,15 MHz 80 MHz 6 Vrms:
in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz 80 % AM at 1 kHz Electromagnetic environment-guidance
(for home and professional healthcare environment) Portable and mobile RF communications equipment should be used no closer to any part of the System including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. IFU-USA-2019-Rev.001 33 Immunity test IEC 60601 test level Compliance level Radiated RF IEC 61000-4-3 10 V/m 80 MHz 2,7 GHz 80 % AM at 1 kHz 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 distance in metres (m). Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 34 IFU-USA-2019-Rev.001 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. Rated maximum output power of transmitter Separation distance according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,7 GHz d =1,2P d =1,2P d =2,3P W 0,01 0,1 1 10 100 0,12 0,38 1,2 3,8 12 0,12 0,38 1,2 3,8 12 0,23 0,73 2,3 7,3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. IFU-USA-2019-Rev.001 35 Manufacturers 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 Distance power
(W)
(m) IMMUNITY TEST LEVEL
(V/m) Compliance LEVEL
(V/m)
(for home and professional healthcare) 385 380 390 TETRA 400 modulation b) 1,8 430 470 GMRS 460, FRS 460 5 kHz deviation 2 1 kHz sine 704 787 LTE Band 13, 0.2 0,3 0,3 0,3 27 28 9 27 28 9 Pulse 18 Hz FM c) Pulse 18 Hz Pulse modulation b) 217 Hz 17 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 800 960 modulation b) 2 0,3 28 28 450 710 745 780 810 870 930 36 IFU-USA-2019-Rev.001 2 450 2400 2570 0,3 28 28 Test frequency
(MHz) Band a)
(MHz) Service a) Modulation b) Maximum Distance power
(W)
(m) IMMUNITY TEST LEVEL
(V/m) Compliance LEVEL
(V/m)
(for home and professional healthcare) 1 845 1700 1990 0,3 28 28 1 720 1 970 5 240 5 500 5 785 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 2 2 Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz 5100 5800 WLAN 802.11 a/n 0.2 0,3 9 9 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. IFU-USA-2019-Rev.001 37 9.5 Federal Communications Commission (FCC) Requirements 9.5.1 The metaReachCGMs 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. 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. 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the users 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 limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
38 IFU-USA-2019-Rev.001
-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.
For body worn operation, this device has been tested and meets FCC RF exposure guidelines. When used with an accessory that contains metal may not ensure compliance with FCC RF exposure guidelines. IFU-USA-2019-Rev.001 39 Chapter 10 Cautions, Contraindications and Warning CAUTIONS
Do not use the metaReachCGMs 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. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.
Do not insert the sensor until you have cleaned the skin near the insertion site with an alcohol wipe.
Using patch might cause allergic reaction, please consult paramedics before
Do not discard your transmitter. It is reusable. The same transmitter is used up
The patch will be valid for 1 day, and transmitter can be valid up to 14 days.
Do not refrigerate the patch and transmitter, and keep the kit away from
Do not replace any applied parts from metaReachCGMs kit including adapter and cable. The metaReachCGMs wont work and cause risks if you mix components from different brands.
Do not use transmitter and patch that have expired. Check the expiry date using it. to 14 days. sunlight. printed on the package. 40 IFU-USA-2019-Rev.001
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 metaReachCGMs (patch, transmitter, and receiver) during Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
Do not allow young children to hold the sensor or transmitter without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard.
Immediately use patch and transmitter when you open it.
Please storage the patch and transmitter between 4-30C and dry place.
If the sensor is far away from receiver (>6 m), the data cannot update immediately and will automatically storage. Wireless communication does not work well through water so the range is much less if you are in a pool.
Unauthorized actions may put you at risk, cause the metaReachCGMs to malfunction.
Calibration process is not needed. If you want to calibrate metaReachCGMs system, please press calibration button to set up the data. Take a fingerstick blood glucose measurement with your blood glucose meter for calibration.
Do not use metaReachCGMs in critically sick patients. IFU-USA-2019-Rev.001 41 charging. battery. happen.
Do not use metaReachCGMs receiver while charging. It is no function while
Dont plug into a computer port to charge.
Dont use an external USB hub; it doesnt provide enough power to charge
Battery can only be charged using the adapter/wall charger.
Stop using metaReachCGMs when malfunctional issues or allergic reactions
Misuse of the USB cable can present a strangulation risk.
If abnormal behavior is observed due to EM disturbances, please relocate the device accordingly. 42 IFU-USA-2019-Rev.001 Chapter 11 Events icons information Icons What it means What you do The icon shall be in orange color and flashing if the patchs lifetime is less than 2 hours. Wait till the patchs 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. 1 Day Replace with a new transmitter. The icon shall be in orange color and flashing if the Patchs lifetime is expired. Expire Replace with a new patch. When the receiver battery level is below 10%, the battery level icon shall be displayed in orange color and flashing. 20%
Use the USB cable with the AC adapter to charge the receiver. IFU-USA-2019-Rev.001 43 Chapter 12 Symbol Information Symbol Title MANUFACTURER EC REP AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY CONSULT INSTRUCTIONS FOR USE CE MARK CAUTION KEEP AWAY FROM SUNLIGHT KEEP DRY BATCH CODE USE BY DATE SERIAL NUMBER 44 IFU-USA-2019-Rev.001 CATALOGUE NUMBER DO NOT REUSE STERILISED USING IRRADIATION STERILISED USING E.O. TYPE BF APPLIED PART DATE OF MANUFACTURE TEMPERATURE LIMIT HUMIDITY LIMITATION NON-IONIZING RADIATION THE WEEE SYMBOL, SEPARATE COLLECTION FOR ELECTRICAL AND ELECTRONIC EQUIPMENT DO NOT USE IF PACKAGE IS DAMAGED IFU-USA-2019-Rev.001 45 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.001 NCC