Yuwell 582 User manual

1430125-0A
User's Manual
Please read the operating instructions carefully!
See certification of quality or packaging for production date
Blood Glucose Meter
Specification model: 582
Five electrode
technology
JIANGSU YUWELL MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Sales Center Address: Huanyuan East Road No.1, Xuzhuang
Software Park, Nanjing, Jiangsu Province, P.R. China, 210000
Manufacturer Address: YunYang Industrial Park, DanYang，
Jiangsu Province, P.R. China, 212300
http://www.yuwell.com
Revision date: September 2020

Welcome to use Yuwell series blood glucose meter
Yuwell blood glucose meter 582 Yuwell blood glucose meter 582
The scope of application: The blood glucose meter is matched with the Yuyue blood
glucose test strip produced by Jiangsu Yuyue Medical Equipment Co., Ltd. It is
used to measure the glucose concentration in capillary whole blood in hospitals and
homes.
This blood glucose meter is matched with the Yuyue blood glucose test strip
produced by Jiangsu Yuyue Medical Equipment Co., Ltd. It is used to measure the
glucose concentration in capillary whole blood in hospitals and homes.
Before using this product, please read this instructions in detail to ensure safe use
and accurate detection. Note:
For important information, please read this instructions in detail to
ensure safe use and accurate detection.
● This product is only used for blood glucose testing and can only be used to test
blood glucose levels in fingertip fresh capillary whole blood. It cannot be used for
the determination of plasma and serum.
● No contraindications.
● This product cannot be used for the diagnosis of diabetes or rapid blood glucose
testing in newborns.
● This product cannot be used for any other test than blood glucose testing.
● The intended users of this product include professional medical staff and lay
person.
● The treatment plan cannot be changed based on the test results without
consulting the doctor or the diabetes expert.
● Please use the meter in a manner specified by Yuwell, or the protection provided
by the meter may be impaired.

Contents
Yuwell blood glucose meter 582
To use this glucose meter properly for daily care of diabetic patients, consult your
doctor or diabetes care specialist.
● Please check whether the packaging of the meter is complete and whether it is
damaged due to transportation.
● If you have any questions about the use of Yuwell blood glucose meters, please
call the National Service Hotline: [phone]
●Yuwell blood glucose meter provides replacement within 5 years and lifetime
warranty service. Please complete your valid information in our warranty card, and
return it to selling pharmacies, distributors or Yuwell, you will become a member of
Yuwell Healthy Home to enjoy a full range of Yuwell member services.
Chapter 1: System Overview
Description.................................................................................................01
Intended Use..............................................................................................01
Blood glucose test strip..............................................................................05
Chapter 2: Preparation for Use of Blood Glucose Meter
Battery installation.....................................................................................06
Mode setting..............................................................................................07
Chapter 3: Testing Blood Glucose
Use of blood sampling pen.........................................................................10
Blood glucose test strip and meter preparation...........................................14
Test of Blood Glucose................................................................................16

Contents Contents
Chapter 4: Memory Function
Display records......................................................................................................18
Check records........................................................................................................18
Clear records..........................................................................................................20
Chapter 5: Quality Control Detection and Icon Settings
Quality control detection.......................................................................................22
Control solution icon settings...............................................................................23
Chapter 6: Storage and maintenance
Storage and maintenance....................................................................................24
Chapter 7: Technical parameters and reference standards
Technical parameters............................................................................................26
Reference standards.............................................................................................29
Chapter 8: Self-monitoring time, monitoring frequency and control
objectives of blood glucose
Self-monitoring time of blood glucose................................................................30
Self-monitoring of frequency of blood glucose..................................................31
Control objectives of blood glucose.....................................................................32
Chapter 9: Other information
Precautions.............................................................................................................33
The symbols and meanings of the safety requirements in this unit................34
Common troubles and elimination methods.......................................................35

Description
Chapter 1: System Overview Chapter 1: System Overview
The yuwell 582 blood glucose meter includes: yuwell 582 blood glucose meter, two
AAA batteries, user manual, a blood sampling pen.
Intended Use
01 02
Battery
Holder
Blood glucose test
strip slot
Display
screen
The yuwell 582 blood glucose meter is intended for use in quantitative measure-
ment of glucose in human whole blood taken from the fingertip(capillary). It is
intended to be used by lay person or clinical site by medical staff.
This system is for in vitro diagnostic use only.
The yuwell 582 blood glucose meter can only used with the yuwell blood glucose
test strip.
The yuwell blood glucose control solution is used with the yuwell 582 blood glucose
meter and blood glucose test strip to check that the meter and test strip are working
together properly. A control test also helps you practice proper testing technique.
△button Ejecting
Pusher
button
△

Chapter 1: System Overview Chapter 1: System Overview
1. Display the storage results
2. Display the correction code
3. In the setting mode
4. Display minutes
5. Display hours
6. Display the test value
7. Unit of measurement
8. Before-meals and after-meals icons
9. Strip and blood icon–add blood
or control into the strip
10. Low battery icon
11. Control solution icon
12. Temperature icon
13. Display the date
14.Display the month
Note: The unit of measurement is present as mg/dL or mmol/L before leave
factory, user can not change.
03 04
Full-screen display: the blood glucose meter will display the following
content after booting 1 2 3
6
7
8
4
5
1
0
11
12
13
14
9

Blood glucose test strips
Chapter 1: System Overview
This product uses electrochemical principle. The blood glucose test strip is inserted
into the blood glucose meter. When the blood droplets come into contact with the
blood inlet port of the blood glucose test strip, blood will automatically siphon into
the reaction zone. The Glucose oxidase catalyzes the redox reaction of glucose in
the blood, resulting in a micro current, and the glucose concentration value (mmol/L
or mg/dL) is calculated and displayed by the blood glucose meter, and then stored.
Side of inserting
into meter
Blood
inlet port
Reaction
zone
Note: please purchase
Yuwell blood test strips and
a blood sampling pen, which
need to be used with the
blood glucose meter!
Battery installation
1. Open the battery back cover.
2. Press the spring with the battery negative pole, insert the battery, install the
battery back cover.
3. Press the battery positive pole with fingernail, and you can remove the battery.
05 06
Note: the battery septum should be withdrawn when using this product for the first
time.
Chapter 2: Preparation for Use of Blood Glucose Meter

1. Enter when the battery is newly
installed or replaced.
2. Press the button ▽ for 3 seconds
to enter mode setting in power off
state.
Chapter 2: Preparation for Use of Blood Glucose MeterChapter 2: Preparation for Use of Blood Glucose Meter
07 08
Mode setting
Enter mode setting 1. The year flashes, press the button △ to set the year (This unit only displays the
last two digits of the year, i.e., 20=2020), press the button to confirm the year and
switch to the month setting.
2. The month flashes, press the button △ to set the month, press the button to
confirm the month and switch to the date setting.
3. The date flashes, press the button △ to set the date, press the button to
confirm the date and switch to the hour setting.
4. The hour flashes, press the button △ to set the hour (this device uses a 24-hour
system), press the button ▽ to confirm the hour and switch to the minute setting.
5. The minute flashes, press the button △ to set the minute, press the button ,
the minute is set and switch to the clock mode.
6. If there is no operation on the blood glucose meter in the setting state within 3
minutes, it will automatically shut down.
Date and time setting
△
△
△
△

Chapter 2: Preparation for Use of Blood Glucose Meter
09 10
Use of blood sampling pen
1. Unscrewing the cap of the blood sampling pen.(or Transparent protective cover)
2. Put the lancet and push the lancet to the bottom of the blood sampling pen
holder.
3. Twist the protection cap from the lancet (Do not shake it left or right to prevent
the needle from bending). Never throw away the protection cap (see procedure 9:
Processing instructions after sampling blood).
2 31
Year setting Month setting Date setting Hour setting Minute setting
Chapter 3: Testing Blood Glucose

11 12
Chapter 3: Testing Blood Glucose Chapter 3: Testing Blood Glucose
4. Install the blood sampling pen cap.
5. Adjust blood sampling depth. Recommended depth 2, users with thicker skin can
adjust deeper appropriately.
6. Pull the handle of the blood sampling pen backward and let it open after hearing
the clicking sound or unable to pull. At this point, the blood sampling pen is ready.
(Please take blood immediately when the meter is ready and prompts blood collec-
tion.)
7. Place the top of the prepared blood sampling pen on the part where the blood is
to be collected, then press the ejection button to collect the blood. Take away the
blood sampling pen after the completion of blood collection.
8. When taking fingertip blood, it is recommended to wipe off the first drop of blood,
and use the second drop.
Before blood collection,
please wash your
hands with soap and
warm water and dry
thoroughly.
7 85 64

Chapter 3: Testing Blood Glucose Chapter 3: Testing Blood Glucose
9. Properly dispose of used lancet:
Unscrew the blood sampling pen adjustment cap, and cover the used lancet tip with
a protection cap to prevent the lancet tip from being exposed. Push the unloading
push rod forward and place the used lancet in a waste container.
9
Note: The blood sampling
pen is limited to one
person and cannot be
used by multiple people.
The lancet is only for
single use, please do not
re-use.
13 14
Blood glucose test strip and meter preparation
1. Insert the test strip into the slot of the
blood glucose meter and push the test strip
to the end. (Trademarks facing upward,
black stripes facing forward)
2. After hearing the beep (if the blood
glucose meter has buzzer), the blood
glucose meter automatically turns on and
displays the code. Check whether the code
on the test strip bottle is consistent with the
code displayed on the blood glucose meter.
(Note: when the two codes are inconsistent,
please test with another new test strip. If the
codes are still inconsistent, please contact
Yuwell customer service staff.)

15 16
Chapter 3: Testing Blood Glucose Chapter 3: Testing Blood Glucose
Note: the detection process should be completed within 3
minutes. The meter will automatically shut down without
operation within 3 minutes.
3. When the blood drop symbol on the screen flashes, it
indicates that blood is being collected. At this time, the date,
time and Calibration code flash alternately on the screen. Set
the pre-meal, post-meal and quality control solution by
pressing the button .
Test of Blood Glucose
1. Lightly touch the blood inlet port with
blood sample, and blood droplets will be
automatically sucked. Do not drip blood
on the test strip.
2. Confirm that he blood volume is
sufficient. We can observe the color of
entire test strip reaction becomes
darker.
△

Chapter 3: Testing Blood Glucose
3. The screen displays the
blood glucose test results for
8 seconds. Do not shake the
instrument while measuring
and counting down.
4. After obtaining the test
results, push the ejecting
pusher to eject the test strip.
The meter will automatically
store the measurement
results and shut down.
17 18
Display records
In the off state, press △ key, the screen
displays the latest test results. Press △ key
again to display all test results in sequence.
The blood glucose meter automatically shuts
down after 15 seconds without operation.
Check records
●Check the test averages for the last 7 days,
14 days, 30 days, 2 months, and 3 months.
●Hold down △ key for 3 seconds in the off
state to display the average blood glucose for
Chapter 4: Memory Function

19 20
Chapter 4: Memory Function Chapter 4: Memory Function
7 days. Press △ key again to display
the average blood glucose for 14
days, 30 days, 2 months, 3 months, 7
days before meals, 14 days before
meals, 30 days before meals, 2
months before meals, 3 months
before meals, 7 days after meals, 14
days after meals, 30 days after
meals, 2 months after meals, and 3
months after meals. The blood
glucose meter automatically shuts
down after 15 seconds without
operation.
Whole group deleting
Press the two △▽ keys together
for 3 seconds during the shutdown
state or in the memory check state,
the "dEL" icon will appear, and the
current memory group data will
flash in the upper right corner.
Press ▽ key at this point and press
again. The number of memory
groups changes to 0, indicating
that the entire memory has been
cleared.
Clear records (Handle with Care)

21 22
Quality control detection
If you want to know whether your blood glucose meter operating system is working
properly, please perform quality control detection on your blood glucose meter.
Note: It is forbidden to use expired control solution. The scrapping disposal
of meters, blood glucose test strips, lancet, batteries and their accessories
must comply with national laws and regulations.
Chapter 4: Memory Function
Current memory
group data
Memory
delete
Chapter 5: Quality Control Detection and Icon Settings

23 24
Chapter 5: Quality Control Detection and Icon Settings Chapter 6: Storage and maintenance
1. Use the control solution detection. After the insertion, press ▽ key to display the
before-meal icon, and press ▽ key again to display the after-meal icon.
2. Press ▽ key again to display the control solution icon . A control solution test
is performed at this point.
3. Replace the blood drop with control solution, and refer to "Test of Blood
Glucose".
Control solution icon settings
C
● Use a non-toxic detergent and warm water to clean the blood sampling pen
adjustment head and dry thoroughly after cleaning. It can also be disinfected with
medical alcohol.
● For the storage of blood glucose test strip, see the test strip instructions.
● Please remove the battery when the blood glucose meter is not used for a long
period of time.
● The product should be stored in a dry, cool, non-corrosive atmosphere and in a
well-ventilated place.
● Transportation and storage:
Ambient temperature range: -10℃~ +50℃
Relative humidity range: <90%, no condensation
Atmospheric pressure range: 500hPa~1060hPa
Storage and maintenance

25 26
Technical parameters
Unit of measurement
Measuring range
Target bloods
Calibration standard
Blood volume
Hematocrit
Testing time
Number of memory groups
Automatic shut-down
Display screen
Equipment operation mode
Supply voltage
Battery life
mmol/L
1.1～33.3 mmol/L (20~600mg/dL)
Fingertip fresh capillary whole blood
Plasma calibration
Reference test strip manual
30%～60%
<10s
Measurement results of 250 groups
15second to 3 minutes
LCD
Continuous operation
DC 3.0V
2 AAA alkaline batteries can measure about 1,000 times
Chapter 6: Storage and maintenance
●Please use a clean, soft, damp cloth to clean the meter, use 75% alcohol,
bleaches or strong cleaners are forbidden. It is recommended to disinfect and
clean the meter daily for use in hospitals, and weekly for personal use.
● Laboratory tests should be conducted regularly and the results of the blood
glucose meter test should be compared with
the laboratory results.
● The maintenance of this product is handled by the customer service center. Do
not beat or disassemble the meter.
● If an accident occurs during the use of this product, call the emergency hotline
immediately and seek the help of a professional medical staff.
Chapter 7: Technical parameters and reference standards

27 28
Chapter 7: Technical parameters and reference standards Chapter 7: Technical parameters and reference standards
Internal power supply equipment, non-AP/APG equipment
(equipment that cannot be used in the presence of flammable
anesthetic gases mixed with air or flammable anesthetic
gases mixed with oxygen or nitrous oxide)
Normal working
conditions
Service life 5 years (Except for wearing parts)
Electrical safety
classification BF application section
Electromagnetic
interference
Electromagnetic interference with other devices has not been
observed in this product, which complies with the current
international electromagnetic emission standards. To avoid
electromagnetic interference in the use environment and affect
the measurement results, keep away from mobile phones,
computers, and other household appliances while measuring.
Ambient temperature range: 10℃～40℃;
Indoor use Relative humidity range: <85%
Equipment type
Note: The dry battery provided with this machine is only used for testing when
the device is turned on. It is recommended to replace the new alkaline dry
battery to ensure that the blood glucose meter will not work due to battery
undervoltage during the test when the testing organization needs to test the
performance of the instrument

Chapter 8: Self-monitoring time, monitoring frequency and control
objectives of blood glucose
Diabetics need to regularly monitor their blood glucose levels to keep abreast of
changes in blood glucose levels. Your doctor will advise you on your blood glucose
test time and control level according to your specific situation. The following is the
blood glucose monitoring time recommended by experts, for reference only!
Self-monitoring time of blood glucose
● Just waking up and having not eaten yet
● Breakfast blood glucose
● 1-2 hours after breakfast
● Before lunch
● 1-2 hours after lunch
● Before and after physical exercise
● Before dinner
● 1-2 hours after dinner
● Before going to bed at night
● After eating dessert
● 2-3 o'clock in the morning
(if insulin is injected)
Chapter 7: Technical parameters and reference standards
29 30
●The result deviation between the blood glucose monitoring system and the
biochemical instrument (clinical lab) is within 95%, which shall follow below:
Precision:
Reference standards
Accuracy:
Test range Accuracy
Not more than ±0.83mmol/L (±15mg/dL)
≤4.2 mmol/L (≤75mg/dL)
＞4.2mmol/L (>75mg/dL) Not more than ±20%
Test range Precision
SD<0.42mmol/L (<7.7mg/dL)<5.5mmol/L (<100mg/dL)
≥5.5mmol/L (≥100mg/dL) CV<7.5%

31 32
Chapter 8: Self-monitoring time, monitoring frequency and control
objectives of blood glucose
● The blood glucose of patients with poor blood glucose control or critically ill
patients should be monitored for 5-7 times a day, 3 days a week until the condition
is stable and blood glucose is controlled.
● When the condition is stable or has reached the goal of blood glucose control, it
can be monitored for 2 times a day, 3 days a week.
● The blood glucose of patients under insulin therapy should be monitored for at
least 5 times a day at the beginning of treatment, and should be self-monitored for
2-4 times a day after reaching the treatment goal.
● The blood glucose of patients taking oral medications and lifestyle interventions
should be monitored for 2-4 times per week.
Self-monitoring frequency of blood glucose
Chapter 8: Self-monitoring time, monitoring frequency and control
objectives of blood glucose
Diabetics need to regularly monitor their blood glucose levels to keep abreast of
changes in blood glucose levels. Your doctor will advise you on your blood glucose
test time and control level according to your specific situation. The following is the
blood glucose monitoring time recommended by experts, for reference only!
Control objectives of blood glucose
Status
Fasting (mg/dL)
Non-fasting (mg/dL)
Glycated hemoglobin (%)
Ideal
79-110
79-144
<6.5
General
≤126
≤180
6.5-7.5
Poor
>126
>180
>7.5