RichHealth metaReach UMB305-0510 User manual

IFU-USA-2019-Rev.001

2 IFU-USA-2019-Rev.001
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
4.4 Turn o 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

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Content
Chapter 8 Troubleshooting
Chapter 9 System Specication
9.1 Receiver Specications
9.2 Sensor Specications
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
Chapter 12 Symbol Information

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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 specied 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 rst 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.

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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.

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Chapter 1 About metaReach® CGMs
1.1 Indications for Use
The metaReach®CGMs is indicated for measuring interstitial uid 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 xed with transmitter on upper arm, and users may
continuously get glucose result via transmitter for 24 hours.
The metaReach®CGMs detection range is dened 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 metaReach®CGMs test
result without consulting healthcare professional.
2. If the glucose result does not match your feelings, please apply a nger blood
glucose testing to conrm. If this issue remains, please remove old patch and
replace a set of new one.

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3. Severe dehydration and excessive water loss may aect 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. Please use it immediately, do not put back for storage. And also, this is
single use product, please dispose it after use.
7. The metaReach®CGMs 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.

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1.2 List of Kit Contents
The System Components is comprised of ve 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
Receiver

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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

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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.

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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 to .

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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.

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3.2 Functions 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 refer to 5.1 Pairing with the Sensor.

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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 ngerstick 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.

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Step Action
5
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 ashing 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
pr
ess
“Product Information”
to go Information screen.

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Step Action
7
I
f 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.

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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 ash blue light.

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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

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Step Action
5
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 aect
the result and sensor may not stick to the site
6 Peeling the lid o completely.
7
Place the Sensor over the prepared
site and push down rmly to apply the
Sensor to your body. When you see
the blue light, it means that the sensor
is secure.

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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.