MEDCHECK SFBG01 User Manual

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User Manual

Bluetooth

Self-Monitoring Blood Glucose System

Model No. SFBG01

Introduction

This booklet has important information you must know about MEDCHECK Self-Monitoring Blood Glucose System (SMBG System in short) with detailed directions and illustrations.

 To ensure that you use properly and obtain the best test results possible,

please read the entire User Manual before testing.

 This package contains 2 new AAA “LR03” (1.5V) Alkaline batteries. Insert

them into SFBG01 by following steps in this manual to ensure normal function.

 If you have any concerns, or need any assistance about maintenance,

please call SMARTFUTURE PTE LTD office or authorized distributor during business hours.

Caution

 To make sure that you operate MEDCHECK SMBG System safely and

accurately, please follow the user manual.

 Please keep MEDCHECK SMBG System away from any liquid or sprays,

keep them dry.

 Do not use MEDCHECK SMBG System on purposes outside “Intended

Use”.

 Only use accessories supplied or recommended by the manufacturer.

 Avoid severe impact on the meter. It may cause malfunction.

 Do not take SFBG01 Blood Glucose Meter apart, or modify anything. Such

action may void your warranty.

 Do not place anything on top of SFBG01 Blood Glucose Meter.

 Keep the whole MEDCHECK SMBG System away from children. They

may choke on battery, or tiny component parts by accident.

 Keep SFBG01 Blood Glucose Meter free from dust, hair, etc. Store the

meter in its container after use.

 If you feel you are suffering from severe dehydration, stop using and

consult healthcare professionals right away.

 If your symptoms are not consistent with blood glucose test results and

you have followed all instructions this manual, seek your healthcare professional for help.

 Dispose of medical waste per local regulations.

 Warning for potential biohazard: Healthcare professionals using this

system on multiple patients should be aware that all products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral disease. So the healthcare professionals should wear disposable gloves and have an inoculation regularly to prevent infections.

Appendices

Explanation of Symbols

Explanation

This product meets the requirements of Directive 98/79/EC in vitro diagnostic medical devices

Lot Number

Use-By date

in vitro diagnostic medical device

AAA “LR03” (1.5V) Alkaline Batteries

Do not reuse

Temperature Limitation

Manufacturer

Follow Instructions for Use

Meter only

Degrees of protection provided by enclosures

Serial Number

Biological Risks

Precision control material for a diagnostic test

Authorized Representative in the European Community

Discard the used product to the recycling collection point according to local regulations

Date of manufacture

Item

Table of Contents

About MEDCHECK SMBG System................................…………………. 07

Intended Use Measuring Principle System Kit Component Description

Key Features……………………………….........................………………… 14

Bluetooth Data Transmission Meal Comment Function Ketone Warning

Get Ready for Testing……………………………..........................……….. 17

Battery Installation Presetting Date and Time

Quality Control of the System……………………............................……. 20

Using Glucose Control Solution

Perform the Blood Glucose Test……………….................………………. 22

Perform the Blood Glucose Test LO and HI Readings Memory Recall

Bluetooth Data Transmission.................................................................. 30

Maintain Your Meter……………………………...........................…………. 31

System Specifications……………………………..........................………. 32

Limitations Product Specifications Bluetooth Specifications

Display Messages and Troubleshooting………….............................…. 35

Device Information……………………………………...........................….. 37

About MEDCHECK SMBG System

Thank you for choosing MEDCHECK SMBG System. Designed for ease of use, the device can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.

Important Information !  Expected Results for Non-Diabetic, Non-Pregnant Adults: The normal

fasting glucose range is 3.9 ~ 5.6 mmol/L (70 ~ 100 mg/dL) Two hours after meals, normal glucose values should be less than 7.8 mmol/L (140 mg/dL)

 Severe dehydration resulting from excessive water loss may cause

false results. If you feel you are suffering from severe dehydration, consult the healthcare professionals immediately.

● Test results below 3.9 mmol/L (70 mg/dL) mean low blood glucose (hypoglycemia).

● Test results greater than 13.3 mmol/L (240 mg/dL) mean high blood glucose (hyperglycemia).

● If you get results below 3.9 mmol/L (70 mg/dL) or above 13.3 mmol/L (240 mg/dL), and do not have symptoms, repeat the test.

● If you have symptoms or continue to get results that fall below 3.9 mmol/L (70 mg/dL) or above 13.3 mmol/L (240 mg/dL), follow the treatment advice of your healthcare professional.

 Record the opening date of test strips on its vial. Discard all unused strips

90 days after opening date. The strips are for single use only.

 If your symptoms are not consistent with blood glucose test results and

you have followed all instructions this manual, seek your healthcare professional for help.

 Warning of potential biohazard: Healthcare professionals using this

system on multiple patients should be aware that all products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral disease.

About MEDCHECK SMBG System

Intended Use

MEDCHECK SMBG System is self-test medical device and intended for both home testing and for professional use to monitor the blood glucose

(β-D-glucose) levels from fresh capillary whole blood obtained from the finger

tip.

It is indicated to be used by diabetics at home or in a clinical setting by professional healthcare personnel to measure the glucose concentration for aiding diabetes management. The owner can only use SFBG01 Blood Glucose Meter with SFTS01/SFTTS02 Blood Glucose Test Strips.

Measuring Principle

We design MEDCHECK SMBG System by using the latest biosensor technology. It measures the glucose levels of the blood specimen by using a disposable dry reagent strip which can produce an electrical current. And the current will transfer to the meter for measurement. The amount of the current is proportional to the amount of glucose present in the blood sample. Test results are “plasma equivalent”.

The system consists of two main products: SFBG01 Blood Glucose Meter, and SFTS02 Blood Glucose Test Strips. These have been designed, tested, and proven to work together and perform accurate results.

Note

 The accuracy of MEDCHECK SMBG System was compared with YSI

2300 Analyzer.

 The patient is an intended operator.

About MEDCHECK SMBG System

System Kit

● SFBG01 Blood Glucose Meter

● SFTS02 10pcs Blood Glucose Test Strips

● SFCS01 Glucose Control Solution (Sold Separately)

● SFTS01 25pcs Blood Glucose Test Strips (Sold Separately)

● Lancing Device

● 10 Lancets

● 2 AAA “LR03” (1.5V) Alkaline Batteries

● Wallet

● Complete instructions:

● User Manual for SFBG01 SMBG System

● Quick Reference Guide

Note

 Please consult your provider/local distributor for extra Blood Glucose

Test Strips .

 If contents of your package do not meet the system kit list above,

please return the whole package to local distributor.

 If the equipment is used in a manner not specified by the

manufacturer, the protection provided by the equipment may be impaired.

About MEDCHECK SMBG System

Component Description

LCD Screen

Displays blood glucose results, messages, and glucose results stored in memory.

S Button

Press to adjust settings and digits

Test Strip Slot

Insert test strip here.

M Button

Press to enter different mode.

SFBG01 Blood Glucose Meter

About MEDCHECK SMBG System

Component Description

SFBG01 Blood Glucose Meter

5 2

1 & 2

Hour & Minute

Month or Year

Day or Year

MEM

AVG

Appear while LCD displays average of past 7 days result.

CODE

Appear while LCD displays code number of the test strips

Apply Blood Symbol

Your meter is ready to measure.

Decimal Point

Appears when LCD displays blood glucose result in mmol/L unit.

ketone Symbol

mmol/L & mg/dL

Temperature Symbol

Appears when ambient temperature exceeds operating temperature.

BT Symbol

Appears when turn on the BT function

Pre-meal or Post-meal Symbol

Indicates whether the test result is taken before or after meal.

Control Solution Test Symbol

Appears while performing Control Solution Mode.

Appear while LCD displays past results.

Low Battery Symbol

Appears when blood glucose result is equal to or higher than 13.3mmol/L (240 mg/dL).

This device can display results in mmol/L unit and mg/dL.

Appears when battery is low

13 10

About MEDCHECK SMBG System

Component Description

Blood Glucose Test Strips

Note

 Only use SFTS01/ SFTS02 Blood Glucose Test Strips with SFBG01

Blood Glucose Meter only.

 Do not touch the strip when your hands are wet.

 Record the first opening date on the vial, and use them within 90

days after first opening. If not, discard them in case inaccurate results may occur.

 Do not use strips beyond the expiration date printed on the vial since

it may cause inaccurate results.

 Blood Glucose Test Strips are for single use only. Never reuse.

 Keep Blood Glucose Test Strips in vial always.

 Bending, cutting, or twisting strips are prohibited.

WARNING

Keep the strip vial away from children; in case any choking hazard happens. The desiccate reagent in the vial may cause skin or eye irritation by contact.

Contact Electrode

Insert into the test strip slot. Insert the test strip as far as it will go.

Top Edge (Collection Zone)

Move blood sample or glucose control solution close to the top edge of the test strip.

About MEDCHECK SMBG System

Component Description

Lancing Device

It is used with sterile lancet to obtain the blood for the testing.

Lancets

It is used with lancing device to obtain the blood for the testing.

Cap

Depth Settings & Indicator

Lancet Ejector

Release Button Cocking Handle

Protective Cap

Needle Handle

Key Features

SFBG01 features a built-in “Bluetooth Data Transmission” function, which enables the device to transmit measured results to paired Bluetooth Smartphone via MedCheck Android or iOS App.

Bluetooth compatibility with blood glucose meter for Bluetooth-enabled device is:

● Bluetooth 4.0 for Android 4.4 or above,

● Bluetooth 4.0 for iOS 8.0 or above

Note

● SFBG01 is subject to and complies with electromagnetic compatibility (EMC) standard of IEC 60601-1-2 rules, EN 301 489-1, EN 301 489-17, and EN 300 328 and U.S. federal guidelines, Part 15 of the FCC (Federal Communications Commission) rules for devices with RF capability. These guidelines help ensure that your device will not affect the operation of other nearby devices. Additionally, other devices should not affect the use of your device.

● Other wireless devices that are in use nearby, such as a cell or mobile phone, or a wireless network, may prevent or delay the transmission of data from your device to paired Bluetooth device. Moving away from the source of the interference or turning off these devices will resolve the problem.

● Make sure SFBG01 and paired Bluetooth device are within acceptable distance (no more than 5 meters) with each other. If not, put them closer.

About Bluetooth Transmission Function

The Bluetooth transmission function might not be workable to some Bluetooth devices because of the compatibility of operation system, and/ or hardware specification.

Please ensure the compatibility before using the Bluetooth data transmission function.

Bluetooth Data Transmission

Key Features

Component Description

Meal Comment Function enables our user to add pre-meal or post-meal symbols on each test result. AC symbol represents pre-meal results, while PC symbol represents post-meal results.

It benefits user to better manage the glucose control plan and also your healthcare professional by providing data when diagnosing and prescribing.

Follow below steps to activate Meal Comment Function:

Under Standby Mode (Right Figure), press S button to enter Meal Comment Setting Mode.

Our default setting is off (Upper Right). Press S button to switch the function on

(Lower Right), or off. When done, press M button and return to

Standby Mode.

Key Features

When having over-intake of calories or insufficient insulin secretion, human body tends to consume fat as energy source. In this case, Ketone, an acid waste, is produced, which can cause damage or cell death. Human body accumulates excessive Ketone in blood and excretes it through urine.

LCD screen displays Ketone Symbol when test result is equal to or higher than 13.3 mmol/L (240 mg/dL). Do not panic, and please test again. If this symbol shows up constantly, promptly consult your physician or medical professional.

For users who have Type 1 diabetes, there is a possibility of ketoacidosis or ketone accumulation.

Note

 For those who do not wish to change meal comment to test results,

simply remove test strip from test strip port after measurement ends. Meter will automatically store your test result in its memory with previous set symbol.

 With Meal Comment Function on:

Pre-meal: Test result appears with Symbol . Post-meal: Our default setting. Test result appears with Symbol .

 When measurement ends, users can replace or Symbol by

pressing S button, depending on their physical status.

Ketone Warning

Get Ready for Testing

The meter uses 2 pieces of AAA “LR03” (1.5V) Alkaline Batteries. For new users, please insert 2 new batteries before use, and please replace old batteries with new ones when Low Battery Symbol shows up

To avoid inaccurate results caused by electromagnetic interference between electrical and electronic equipments, do not use the device near a mobile phone or microwave oven.

Note

 If the symbol flashes, that means the power is too low to work.

 Previously stored memories will not be erased when batteries are replaced.

 After batteries are replaced, please reset year, date and time again.

 All batteries used must be the same type. Do not mix alkaline, standard

(carbon-zinc) or rechargeable (cadmium) batteries

 Do not mix new and old batteries.

 To save the power, please take out the batteries if you do not use the meter

for a long period (approx. 2 months or more).

 Batteries are hazardous waste. Do not dispose of them together with the

household garbage. Please discard worn-out batteries to the recycling site according to local regulations.

Battery Installation

Slide battery cover from back of meter.

Install 2 new AAA alkaline batteries in accordance with correct polarities.

Put the battery cap back.

Get Ready for Testing

Presetting Date/ Time/ Unit

Please pre-set your meter whenever you insert or replace the batteries. See following steps for details.

Under Standby Mode, press and hold M button for 3 seconds to enter Setting Mode.

Note: After battery replacement, meter

automatically activates Setting Mode.

When YEAR digits flash, press S button to select current year. When done, press M button to confirm.

To complete date and time settings, repeat above steps by setting MONTH, DATE, HOUR and MINUTE in sequence.

After setting the correct year, select preferable unit by pressing S button.

When done, press M button to confirm.

Get Ready for Testing

Note

● After the screen displays the symbol, press M button, you can return

to the Code Setting Mode.

● Before measurement, make sure the code number on the vial matches

number you set in order to get an accurate result.

● After inserting a new strip, user can directly activate Code Number

Setting Mode by pressing M button. Follow above two steps to complete setting.

Setting Test Strip Code Number

There are two ways to set the strip code: 1) press S button for 3 seconds in standby mode or 2) insert the strip at any time and press the M button.

LCD displays upper right figure, adjust numeral digit per following steps:

● Press S button to adjust numeral digits until it matches with code number printed on the Test Strip vial.

● When done, press M button to confirm.

C03

Quality Control of the System

C03

Using Glucose Control Solution (Sold Separately)

The purpose of SFCS01 Glucose Control Solution is to perform a quality control test to verify whether your meter and test strips are working together properly. Please contact Smartfuture Pte Ltd or local distributor to buy SFCS01 Glucose Control Solution.

There are two levels of Glucose Control Solutions for different acceptable ranges: High Level and Low Level. We recommend testing with both levels of Glucose Control Solution.

● How does it work?

A known amount of glucose in the control solution reacts with SFTS02 Blood Glucose Test Strip.

● Who or when to perform a control solution test?

 Strong impact on the meter.  When your symptoms do not agree with the way you feel, or when the

result is higher or lower than expectation.

 Whenever users wish to check whether Blood Glucose Test Strip and

Blood Glucose Meter are working properly.

Insert test strip into test strip slot. Meter displays previous set Code Number.

Check whether the code number on the vial match with the code number displayed. If not, see “Setting Test Strip Code Number” section to adjust it.

Note

 For accurate results on both blood glucose measurements and quality

control tests, use SFCS01 Glucose Control Solution only.

 Results of quality control tests will not be stored in the memory.

When symbol flashes, press S button to activate Quality Control Mode.

With symbol on, your meter is ready to perform quality control test.

Quality Control of the System

Shake the vial of Glucose Control Solution well before use. Squeeze the vial but discard the first droplet.

Squeeze the second droplet to your clean fingertip or on a clean object such as a transparency.

Move the collection zone of test strip close to Glucose Control Solution droplet.

Collection zone automatically drink the droplet in. When full, your meter beeps and counts down for 5 seconds.

When results match with acceptable range printed on the Test Strip vial, your System is working properly.

Note: Check the Test Strip vial for acceptable ranges

for High and Low Levels. Refer to Glucose Control Solution instruction before use.

Note

To avoid contamination, do not apply the control solution to the test strip directly from the bottle.

Understanding Your Test Results

When results match with acceptable range printed on the Test Strip vial, your System is working properly, and your test results are reliable.

If your results do not match with the acceptable range, please check the following:

 Are the control solutions or test strips within the expiration date?  Has the control solution been contaminated?  Is the code number correct?  Did you follow the test procedures correctly?

Please repeat the test. If results still do not match, contact Smartfuture Pte Ltd or the authorized distributor.

Perform the Blood Glucose Test

CAUTION

 To avoid infection, do not share the lancing device and lancets with

other people. The lancet is for single use only. Never reuse them.

 Be sure to save the protective cap of the lancet for later use.

Remember to put it back on to the lancet before disposal.



When or appears, ambient temperature falls out of acceptable range (10 °C ~ 40 °C / 50 °F ~ 104 °F). Leave your meter in a room around 10 °C ~ 40 °C (50 °F ~ 104 °F) for 15 minutes, then repeat the test. Do not artificially heat or cool the meter.

 The strip is for single use only. Dispose of Test Strip that has blood or

control solution on it.

Twist the cap of the lancing device to remove it.

Insert the lancet firmly into the circular lancet holder of lancing device until it is fully seated.

Twist off the protective cap of the lancet and save it for later use.

Perform the Blood Glucose Test

Replace and screw the cap snugly. Choose the depth of lancing.

Select 1~2 for soft or thin skin, 3-4 for average skin, 5-6 for thick or calloused skin.

Pull the cocking handle out until it clicks.

Wash hands first, or use an alcohol swab to wipe your finger clean. Wait until your hands are totally dry.

Insert the test strip into the test strip slot as the figure on the right.

Meter displays previous set Code Number.

NOTE: The meter does not response to any

other ways of inserting.

Perform the Blood Glucose Test

Check whether the code number on the vial matches with the code number displayed. If not, see “Setting Test Strip Code Number” section for details.

Hold the lancing device firmly against the side of your finger tip.

Let go of the Release Button to take a sample.

With symbol on, your meter is ready for use.

To avoid body fluid contamination, wipe off the first drop of blood with a clean gauze or cotton. Gently squeeze the fingertip to obtain the second drop of blood for testing.

C03

Perform the Blood Glucose Test

NOTICE

Your Test Strip doesn’t have enough blood sample on it. An unfilled collection zone may lead to false or inaccurate result.

A totally filled collection zone.

Do not drip your blood sample on the top of the test strip.

Instead, move the test strip close to blood sample, and let collection zone automatically drink the droplet in.

Make sure to apply enough blood on the collection zone of the Test Strip. An unfilled collection zone may lead to false or inaccurate result.

Move the collection zone close to your finger tip. Do not drip your blood sample on the top of the test strip.

Note

User can replace or Symbol by pressing S button, depending on their physical status.

Pre-meal: Test result appears with Symbol .

Post-meal: Our default setting. Test result appears with Symbol .

Perform the Blood Glucose Test

Meter beeps when blood is detected, and user can then move your finger away.

With Meal Comment Function on, test result appears with flashing or symbol, depending on the setting.

Dispose of medical waste per local regulations.

Glucose test result displays in 5 seconds.

After testing, push the lancet ejector forward to remove the lancet. Be sure to put protective cap of the lancet back before disposal.

Remove the test strip to shut the meter off. Without any operation for 2 minutes, the meter automatically shuts off too.

Perform the Blood Glucose Test

LO and HI Readings

MEDCHECK SMBG System can display results from 1.1 to 33.3 mmol/L (20 to 600 mg/ dL).

1. If your test result is lower than 1.1 mmol/L (20 mg/dL), “LO” appears on

LCD screen. The result will be stored in the memory but does not count in the average of last 7 days.

Important information!

 LO reading with symptoms!

If you have “LO” test results and also symptoms such as weakness, sweating, nervousness, headache or confusion, follow your doctor’s recommendation to treat hypoglycemia.

 LO reading without symptoms!

If you have “LO” test results but no symptoms of low blood glucose, please consult your doctor or call your local distributor for help.

2. If your test result is higher than 33.3 mmol/L (600 mg/dL), “HI” appears on

LCD screen. The result will be stored in the memory but does not count in the average of last 7 days.

Important information!

 HI reading with symptoms!

If you have “HI” test results and also symptoms such as fatigue, thirst, excess urination, or blurry vision, follow your doctor’s recommendation to treat hyperglycemia.

 HI reading without symptoms!

If you have “HI” test results but no symptoms of high blood glucose, please consult your doctor or call your local distributor for help.

Note

1. To ensure accurate average values, please re-set date and time before use.

2. Average result of last 7 days is calculated from test results performed during the last 7 days.

3. “LO” and “HI” results do not count in the average of last 7 days.

4. With Meal Comment Function on, Pre-meal or Post-meal Symbol will also appear under Memory Mode.

Note

To quit Memory Mode, press S button and return to Standby Mode.

Perform the Blood Glucose Test

Memory Recall

SFBG01 Blood Glucose Meter can store up to 120 test results with date and time automatically in its memory. When full, the meter will replace the oldest with the latest result automatically. User can also view their average results of last 7 days with ease.

Follow steps below to recall memory sets:

Understanding Average Results

Take average of last 7 days for example. While displaying average results, “07d” on the upper left represents the result displaying now are from last 7 days. “021” on the upper right represents how many results are performed during last 7 days.

Average result of last 7 days appears first.

Under Standby Mode, press M button to enter Memory Mode.

Perform the Blood Glucose Test

Press M button again, the meter start displaying each test result with memory sequence number, and then corresponding date and time.

Keep pressing M button, user can scroll thorough all memory sets from the latest to the oldest.

When done, press S button to return to Standby Mode.

Press S and M buttons for 3 seconds, the screen will show "dA" for confirmation.

Press S button again for 3 seconds to delete all records.

Or if you want to check out the delete function, press M button to return to Standby Mode.

To delete all records

NOTE: Once deleted, your data can NOT be

restored.

Bluetooth Data Transmission

To activate Bluetooth function, please make sure you have MedCheck App downloaded in your Android or iOS Smartphone. For all features of MedCheck App and step-by-step guide, please visit www.getmedcheck.com.

Once connected and receive the data request from APP, the screen flashes “ ” symbol, and the paired Bluetooth device automatically starts downloading measured results from glucose meter, if they are in an acceptable range (no more than 5 meters).

SFBG01 can only pair up with one Bluetooth device at a time. To transmit measuring results to other Bluetooth device, please redo steps 1~2.

NOTE: Please do not turn on more than one Bluetooth transmission

function of glucose meters.

Maintain Your Meter

Display Check

When the meter is off, press any key to switch it on. The display should look exactly like the figure in the right.

If not, contact Smartfuture Pte Ltd.

Cleaning

● Wipe the outside of the meter with a soft cloth that has been slightly dampened with water. Watch out for ingress of water while wiping Test Strip Slot.

● Wipe the outside of the lancing device with a soft cloth dampened with alcohol or soap with water.

Storage and Handling

● Keep your meter free from dust, and extreme weather.

● Always handle your meter with care.

● Run a quality control test after strong impact of the meter.

● If the device is not to be used for a long time, please remove the

batteries from the device (leaking of battery acid can cause the device to malfunction).

Important Information

 Watch out for ingress of water while wiping Test Strip Slot.

 Do not dip your meter in water, or any other liquid.

 Do not implement the maintenance procedures for equipment during

measurement.

System Specifications

Limitations

Do NOT use serum or plasma sample.

Do NOT use neonate blood sample.

Blood Glucose Test Strips are for single use only.

Never reuse a test strip that had either blood or control solution applied to it.

Use MEDCHECK SMBG System at room temperature between 10 °C ~ 40 °C (50 °F ~ 104 °F). Out of this range, the device just won’t work.

Extreme humidity may affect the results. A relative humidity greater than 80% may cause incorrect results.

Hematocrit:

 Hematocrit ranging from 30 % ~ 55 % has no significant impact on

test results.

 Other ranges:

Hematocrit > 55 %: may lead to incorrect low test results. Hematocrit < 30 %: may lead to incorrect high test results.

 To know exact hematocrit level of yours, consult healthcare

professional for help.

System Specifications

Product Specifications

Model Name Range Response Time Memory Sets Operating Condition

Storage Condition Transportation Condition Blood Volume Sample Type Hematocrit (Hct) Power Supply Battery Life Product Life

LCD Dimension Device Dimension Weight Principles

SFBG01 Blood Glucose Meter

1.1 ~ 33.3 mmol/L (20 ~ 600 mg/dL) 5 seconds 120 Memory Sets Temperature Humidity Altitude Atmospheric pressure Meter Strip Meter Package with Lancets or Strips

> 1 μL

Capillary Whole Blood 30 % ~ 55 % 2 AAA “LR03” (1.5V) Alkaline Batteries At least 1000 measurements (under Bluetooth Function OFF status) Meter: 8000 times/5 Years (4 times per day) Strip: shelf life : 18 months ;shelf life after opening: 90 days(below 40°C) Control: shelf life : 18 months ;shelf life after opening: 90 days (below 40°C) 40 x 29 mm 88 ( L ) x 58 ( W ) x 23.2 ( H ) mm

48.2 g (Without Batteries) Electrochemical Biosensor Technology

10 °C ~ 40 °C (50 °F ~ 104 °F) R.H. ≦ 80 % ≦ 3000 m 700 ~ 1060 hPa

-10 °C ~ 50 °C (14 °F ~ 122 °F) R.H. ≦ 90 % 2 °C ~ 40 °C (35.6 °F ~ 104 °F) R.H. ≦ 90 %

System Specifications

Bluetooth Specifications

RF Type RF Modulation Effective Radiated Power Data Throughput Expected Delay (Latency Range) in Wireless (RF) Communication Integrity

Security Operating Distance RF Frequency / Need for Spectrum Management Maximum Limitation Maximum Permitted Power Proximity of Other In-band Transmitters Used in Vicinity Wireless Communication Profile Wireless Coexistence System requirement of the Bluetooth device

Bluetooth 4.0 BLE GFSK 0 dBm

0.2Mbps The latency time is less than 0.3ms second from sender to receiver. Channel Quality-Driven Data Rate (CQDDR) technology increases the effective data rate and integrity in noisy environments. AES-128 and application layer user defined Class 2 (no more than 5 meters) 2402 - 2480 MHz (allowing for guard bands) Unlimited

2.5 mW Up to 40 bands (2 MHz spacing; centered from 2402 to 2480 MHz) GATT – Client and Server Support for 802.11 Coexistence Android 4.4 or above, iOS 8.0 or above

Display Messages and Troubleshooting

Display

Messages

What It Means Troubleshooting

"Er 1” appears when the strip is wet.

● Perform the test in a room around 10 °C ~ 40 °C, and R.H. ≦ 80 %.

● Repeat the test with a new Test Strip.

● See "Perform the Blood Glucose Test” Section.

"Er 2" appears when the meter fails to access memory.

If "Er 2" appears constantly, please contact SMARTFUTURE PTE LTD or local distributor during business hours.

"Er 3" appears when your Test Strip does not have enough blood sample on it.

● Repeat the test with a new Test Strip.

● See "Perform the Blood Glucose Test” Section.

"HI" and "LO" appear when your results fall out of measuring range.

The result will be stored in the memory but does not count in the average of last 7 days.

● Repeat the test with a new Test Strip.

● See "Perform the Blood Glucose Test” Section.

Display Messages and Troubleshooting

Display

Messages

What It Means Troubleshooting

When “HI t” or “LO t” appears, ambient temperature falls out of acceptable range (10 °C ~ 40 °C / 50 °F ~ 104 °F).

The meter is unable to measure.

● Do not artificially heat or cool the meter.

● Leave your meter in a room around 10 °C ~ 40 °C (50 °F ~ 104 °F) for 15 minutes, then repeat the test.

● See "Perform the Blood Glucose Test” Section.

When appears, your batteries are about to run out.

When appears, the batteries are too weak to work.

● Repeat the test after battery replacement.

● See "Get Ready for Testing " section.

Ketone Symbol appears when result is equal to or higher than 13.3 mmol/L (240 mg/dL).

For users who have Type 1 diabetes, there is a possibility of ketoacidosis or ketone accumulation.

Promptly consult your physician or medical professional.

Device Information

MEDCHECK SMBG System

SFBG01 Blood Glucose Meter SFTS02 10pcs Blood Glucose Test Strips SFCS01 Glucose Control Solution (Sold Separately) SFTS01 25pcs Blood Glucose Test Strips (Sold Separately)

9F, No. 186, Jian Yi Road, Zhonghe District, New Taipei City, Taiwan www.healthandlife.com.tw

Prinsessegracht 20, 2514 AP The Hague, The Netherlands

Smartfuture Pte Ltd

#06-01, 178 Paya Lebar Road,

Singapore 409030

support@oursmartfuture.com

www.oursmartfuture.com

Ph: +65-68487962

www.getmedcheck.com

HEALTH & LIFE CO., LTD.

EMERGO EUROPE

Device Information

Lancing Device

Meets the requirement of MDD 93/42/EEC

No. 68, Litanghe Road, Xiangcheng, Suzhou, China 215131 Tel: +86-512-65799308

SteriLance Medical (Suzhou) Inc.

Lancets

Meets the requirement of MDD 93/42/EEC

No. 68, Litanghe Road, Xiangcheng, Suzhou, China 215131 Tel: +86-512-65799308

SteriLance Medical (Suzhou) Inc.

Device Information

Warranty

Smartfuture Pte Ltd warrants that your SFBG01 Blood Glucose Meter will be free from defects in materials and workmanship for two year from the date of purchase. If during this two-year period, the meter does not work properly because of a defect in materials or workmanship, SMARTFUTURE PTE LTD will repair the meter or replace it with a new SFBG01 Blood Glucose Meter or equivalent product free of charge.

The warranty of the repaired or replacement meter will expire on the date of the original warranty expiration or ninety days after shipment of a replacement meter, whichever period is longer.

Note

This warranty applies only to the original purchaser of the meter.

P/N：323103072 VER：001

www.getmedcheck.com

MEDCHECK SFBG01 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual