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IFU-USA-2019-Rev.001

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

(MHz)

Service

Modulation

Maximum

power

(W)

Distance

(m)

IMMUNITY

TEST LEVEL

(V/m)

Compliance

LEVEL

(V/m)

(for home and

professional

healthcare)

385

380 –390

TETRA 400

Pulse

modulation

18 Hz

1,8

0,3

450

430 – 470

GMRS 460,

FRS 460

±5 kHz deviation

1 kHz sine

0,3

710

704 – 787

LTE Band 13,

Pulse

modulation

217 Hz

0.2

0,3

745

780

810

800 – 960

GSM 800/900,

TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

Pulse

modulation

18 Hz

0,3

870

930

Содержание metaReach UMB305-0510

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 47: ...NCC 1...

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