Owner’s Booklet
UA-105 Uric Acid Monitoring System
Contents
Comparing Your Meter Result to a Laboratory Result
·
·······················
Troubleshooting ·······························································
Introduction ········································································
Getting to know your system ···················································
Setting up your meter······························································
Testing your Uric Acid·····························································
Memory and averages ···························································
Control solution testing ···························································
01
05
09
13
22
23
25
33
Technical information ························································
Disposing of the meter, test strips, lancets and batteries ···········
Warranty ·········································································
Traceability ······································································
Performance Characteristics ···············································
Symbol Index ···································································
Appendix ·········································································
36
38
39
40
43
41
45
Maintenance ····································································
30
Introduction
1
Thank you for choosing Sejoy UA-105 uric acid monitoring system.
Before you start testing, carefully read this Owner’s Booklet.
Intended Use
Test Principle
Peel off the insulation film from battery compar tment before first use.
*
The Sejoy US-101 Test Strips are used with the Sejoy UA-105 Uric
Acid Meters to quantitative measuring uric acid with fresh capillary
whole blood from the finger or venous blood. The test strips can be
used for self-testing at home or for professional use. It is not used
for diagnosis, screening nor for testing newborns.
The product is for in vitro diagnostic use only.
The Sejoy US-101 Test Strip is a plastic strip containing chemistries
and electrodes.The strip measures uric acid by using amperometric
technology employing an uric acid electrochemical reaction.
When whole blood from the finger or control solution is drawn into
the tip of a test strip, uric acid in the sample reacts with chemicals
and produces an electrical current. The meter measures electrical
current and calculates amount of uric acid. The uric acid result is
displayed as a calculated plasma value.
Introduction
Important Safety information
Warning
• During normal testing, any uric acid meter or lancing device may come
in contact with blood. All parts of the kit are considered biohazardous and
can potentially transmit infectious diseases from blood borne pathogens,
even after you have performed cleaning and disinfecting.
• The meter and lancing device should never be used by more than one
person. Do not share the meter and lancing device with anyone, including
family members, due to the risk of infection from blood borne pathogens.
• Cleaning and disinfecting the meter and lancing device destroys most,
but not necessarily all, blood borne pathogens.
• If the meter is being operated by a second person who is providing testing
assistance to the user, the meter and lancing device should be cleaned
and disinfected prior to use by the second person.
• Disinfect the meter and lancing device before allowing anyone else to handle
them. Do not allow anyone else to test with the meter or lancing device.
For instructions on how to clean and disinfect the meter and lancing device,
see Chapter Maintenance.
• Wash hands thoroughly before and after handling the meter, lancing device,
or test strips.
• Choking hazard. Small parts. Keep away from children.
• Strong electromagnetic fields may interfere with the proper operation of the
meter. Do not use this meter close to sources of strong electromagnetic
radiation.
• To avoid electrostatic discharge, do not use the meter in a very dry
environment, especially one in which synthetic materials are present.
2
3
or the material for safe handling and/or prior to disinfecting.
• It is important to keep the meter and lancing device clean and disinfected.
Clean and disinfect the lancing device once per week to remove visible dirt
• Venous whole samples collection and preparation should be obtained
by healthcare professionals.
Introduction
3
Important Health-Related information
·Run a control test when you open a new box of test strips or if you think
that your test result is incorrect. Running a control test lets you know
that the meter and test strips are working properly.
·DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT
THAT DOES NOT MATCH HOW YOU FEEL OR IF YOU BELIEVE THAT
YOUR TEST RESULT COULD BE INCORRECT. If your uric acid result
doesn’ t match how you feel and you have followed the instructions
in this manual, follow your doctor’s instructions, or call your doctor.
·Children should be taught how to use the meter and any other medical
products appropriately
·If you have followed all the instructions in this booklet and still have
symptoms that don’t seem to match your test results – or if you have
questions – talk to your doctor.
·The sejoy Uric Acid monitoring system UA-105 is designed for using
with fresh capillary whole blood from the finger or venous samples.
·Hematocrit range: 30% to 55%. Hematocrit below 30% or above 55%
may cause deviated results.
·Severe dehydration and excessive water loss may cause false low
results. If you think you may be dehydrated, consult your healthcare
professional immediately.
·Ascorbic acid, Glucose and Creatinine will not affect the test results
at normol physiological concentration.
Introduction
4
·The concentration of Acetaminophen above 1.0mg/dL and that of
L-DOPA above 0.5 mg/dL may affect the test results.
·High concentration of Cholesterol up to 500 mg/dL and that of
Triglycerides up to 300 mg/dL will not affect the test results.
·The user is suggested to test uric acid in the morining after fasting for
12 hours.
Getting to know your system
5
a
b
c
d
a. Meter (battery included)
b. Test Strips
c. Lancing Device
d. Sterile Lancet
e. Control Solution
INCLUDED WITH YOUR KIT
e
Beijing Ruicheng Medical Supplies Co., Ltd.
No. 558 Zhangzikou, Yangsong Town, Huairou District, 101400 Beijing, China
Lotus NL B.V.
Koningin Julianaplein 10, le Verd,2595AA, The Hague, Netherlands.
CE for lancing device; CE0197 for sterile lancet
EC
REP
Shandong Lianfa Medical Plastic Products Co., Ltd.No.1
Shuangshan Sanjian Road, 250200, Zhangqiu City, Jinan, Shandong, PEOPLE’S
REPUBLIC OF CHINA
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg Germany
EC
REP
Getting to know your system
a. Meter
Strip Port
LCD
“M”Button
“S” Button
Battery Cover
Battery
Compartment
Display
Measuring Unit
Test Strip Reminder
Apply Blood Sample Reminder
Memory
Low Battery Reminder
Test Result
Month
Date
Voice
Time
Average
Alarm Clock Reminder
6
o
Temperature is out of range
Getting to know your system
b. Test Strip
Warning: The cap or vial contains drying agents that may be
harmful if inhaled or swallowed and may cause skin or eye
irritation.
Contact Bar: Insert it into strip por t. Push it all the way until it will go
no fur ther.
Top Edge: Apply blood sample here
Confirmation Window: Sample checking area
Impor tant: the meter should only be used with US-101 test strips.
Using other Test strips with this meter can produce inaccurate results.
Impor tant Test Strip Information
• The system has an operating range of 10℃ ~ 40℃(50℉ ~ 104℉).
• Store the test strip package in a cool, dry place between 1℃ ~
30℃
(33.8℉ ~ 86℉).
• Use test strips only within the system operating temperature range.
• Keep away from direct sunlight or heat.
• Store your test strips in their original vial only; never transfer them
to
another vial or any other container.
• Never store individual test strips outside the vial.
• After removing a test strip from the vial, immediately close the vial
cap
tightly.
• With clean, dry hands, you may touch the test strip anywhere when
7
Contact Bars
Top Edge
Confirmation Window
UricAcid
Getting to know your system
d. Lancet
c. Lancing Device
Protective Cover
Lancet Pin
Lancet Ejector
Trigger Button
Sliding Barrel
Lancet Carrier
Protective Cover
Lancing Device Cover
Arrow
Adjustable Tip
8
Setting up your meter
When use the meter for the first time, please set the parameters of the
meter. With the meter off, long press button “S” to enter into setting mode.
Set the month
Press and release the button “M”
to advance one month until the correct
month appears
.
After the month is set, press button “S”,
the Date figure is flashing automatically.
Set the date
Press and release the button “M” to advance one
day until the correct date appears.
After the date is set, press button “S”, the Hour
figure is flashing automatically.
Set the hour
Press and release the button “M” to advance one
hour until the correct hour appears.
After the hour is set, press button “S”, the Minute
figure is flashing automatically.
①
②
③
9
Setting up your meter
Set the minute
Press and release the button “M” to advance one
minute until the correct minute appears. After the
minute is set, press button “S”, the Time format
figure will appear.
OR
Set the measuring unit
The meter can display test
results in either milligrams per
decilitre (mg/dL) or micromole
per litre (umol/L). Press and
release button “M” to select the
preferred format. With the
preferred measuring unit format
on the display, press button “S”
to enter the voice setting.
④
⑥
The meter can display the time
in either an AM/PM (12-hour) or
a 24:00 (24-hour) format. Press
and release button “M” to select
the format.
With the preferred time format
on the display, press button “S”,
the measuring unit figure will
appear.
Set the time format
⑤
OR
10
o
Setting up your meter
OR
Set the alarm clock
The meter can set an alarm
clock to remind you the
time for testing.
Press button “M” to check
the alarm function.
If the alarm is on, press
button “S”, the time figure
is flashing. Please refer to
step 3 and 4 for the time
setting. After the time is
set, press button “S” button
to exit the setting mode.
If there is no alarm function
requirement, press button “S”
to enter the code setting.
⑧
OR
⑦
Set the voice
The meter can set the voice
in either an on or an off
format.Press and release
button “M” to select the
format.
With the preferred voice
format on the display, press
button “S” to enter the alarm
clock setting.
11
Setting up your meter
12
⑨ Set up the code
Align the label area on the
back of the uric acid
instrument with the RFID
on the cover of the test
box.And check that the
code number displayed
on the screen is
consistent with the code
number marked on the
test box.
RF ID
CH IP
Testing your uric acid
Preparing the lancing device
Warning
• During normal testing, any uric acid meter or lancing device
may come in contact with blood. All parts of the kit are considered
biohazardous and can potentially transmit infectious diseases
from bloodborne pathogens, even after you have performed
1,2
cleaning and disinfecting.
• The meter and lancing device should never be used by more than
one person. Do not share the meter and lancing device with
anyone, including family members, due to the risk of infection
from bloodborne pathogens.
• Cleaning and disinfecting the meter and lancing device destroys
most, but not necessarily all, bloodborne pathogens.
• If the meter is being operated by a second person who is
providing testing assistance to the user, the meter and lancing
device should be cleaned and disinfected prior to use by the
second person.
• Disinfect the meter and lancing device before allowing anyone
else to handle them. Do not allow anyone else to test with the
meter or lancing device.
• It is important to keep the meter and lancing device clean and
disinfected. For instructions on how to clean and disinfect the
meter and lancing device, see Chapter Maintenance.
• Wash hands thoroughly before and after handling the meter,
lancing device, or test strips.
• You must not insert the lancet cap into the lancing device and
simultaneously press the release button or hold the lancing
device with the release button resting on a surface such as a
table top. This could release a lancet and inadvertently cause
injury.
13
Testing your uric acid
Preparing the lancing device
① Twist off the lancing device cover.
② Insert a new lancet into the lancet carrier firmly.
③ Hold the lancet needle cover and gently twist
it until it separates from the lancet.
④ Replace the lancing device cap.
Avoid touching the lancet pin.
⑤ Adjust the depth setting
The adjustable tip offers 5 levels of skin
penetration. Twist the lancing device cap
until the desired setting appears.
Note: To select the best depth:
1-2 for soft or thin skin 3 for average skin.
4-5 for thick or calloused skin.
14
Testing your uric acid
Preparing the lancing device
⑥ Hold the lancing device cover in one hand.
Using the other hand, slowly pull the sliding
Barrel away from the lancing device cover.
You will hear a click, indicating that the lancet
carrier is locked into position. Release sliding
barrel to return it to its original position.
15
Testing your uric acid
Blood Sampling
① Wash your hands and the puncture site
with an alcohol swab or soapy water.
Rinse and dry thoroughly.
② Position the end of the adjustable comfort tip
against the side-tip of the finger. Press the
trigger button, and then lift the lancing device
③ Gently squeeze your finger until you get a
round drop of blood.
If the blood smears or runs, Do Not use that
sample. Wipe the area and gently squeeze
another drop of blood or puncture a new site.
Approximate size
away from the finger after the puncture is
complete. Place the lancing device aside and
wait a few seconds for a blood drop to form.
16
Testing your uric acid
Blood Sampling
IMPORTANT:
• Use only Test Strips US-101.
• Make sure your meter and test strips are about the same temperature
before you test.
• Testing must be done within the operating temperature range
10℃ ~ 40℃ (50 ℉ ~ 104 ℉).
For the most accurate results, try to test as close to room temperature
20℃ ~ 25℃ (68 ℉ ~ 77 ℉)as you can.
• Tightly close the cap on the vial immediately after use to avoid
contamination and damage.
• Store unused test strips only in their original vial.
• Do Not open the test strip vial until you are ready to remove a test strip
and perform a test. Use the test strip immediately after removing it from
the vial.
• Do Not return the used test strip to the vial after performing a test.
• Do Not re-use a test strip that had blood or control solution applied to it.
Test strips are for single use only.
• Write the first open date on the vial label when you first open it. Discard
the vial 3 months after first open date.
17
Testing your uric acid
Testing
Note: If you do not start the test within three minutes, the
meter will turn off. To restart your meter, take out the
unused test strip and reinsert it into the meter.
Important: The meter should only be used with US-101
test strips. Using other test strips with this meter can
produce inaccurate results.
② System check screen
Each time the meter powers on, this screen briefly
appears so that you can make sure the display is
working properly.
Note:
•If appears, it indicates the operating temperature is
over range. Place the system in operating temperature
room for half hour. Then test again.
•If appears, it indicates the battery is almost out
of power. Replace the battery now.
③ The blood drop symbol flashes on the display screen.
Your meter is now ready to apply blood sample.
18
① With meter off or in setting mode and memory mode,
insert a test strip to enter into testing mode.
o
Testing your uric acid
Testing
⑥
Your uric acid level appears on the display, along
with the unit of measure, the date and time of the test.
Uric acid results are automatically stored in the
meter’s memory.
Read your result on the meter
④ Apply the sample
Gently touch the channel to the edge of the blood drop.
Note:
• Discard the first drop of blood. Do Not smear or scrape
the drop of blood with the test strip.
• Do Not apply more blood to the test strip after you have
moved the drop of blood away.
• Do Not move the test strip in the meter during a test.
⑤ Wait for the confirmation window to fill completely
The blood drop will be drawn into the narrow channel
and the confirmation window should fill completely.
When the confirmation window is full, this means
you have applied enough blood. Now you can move
the test strip away from the blood drop and wait for
Full
Not full
19
the meter to count down from 20 to 1with 2 beep sounds
indicating the end of test.
o
Testing your uric acid
⑦ Delete the memory
If you don’t want to keep the test result, press “S”button
and “M” button to delete itat the same time. After memory
cleared, the meter will display “dEL” for aprrox.3 minutes
and then automatically turn off.
⑧ Turn your meter off.
Simply remove the test strip. Carefully dispose the
used test strip.
20
o
Testing your uric acid
Interpreting unexpected test results
The meter can accurately measure uric acid concentrations
between 180 to 1190 umol/L (3 to 20 mg/dL).
Expected Uric Acid Level:
Reference values
202-416 umol/L（3.4-7.0 mg/dL）
142-360 umol/L （2.4-6.0 mg/dL）
Male
Female
Recommend
Refer to the following cautions whenever your test results are lower or
higher than what you expect.
① Low uric acid results
If your test result is lower than 180 umol/L(3 mg/dL),
LO will appear on the meter display screen.
21
② High uric acid results
If your test is above 1190 umol/L( 20 mg/dL ), HI
will appear on the display screen.
Comparing Your Meter result to a Laboratory result
Comparing your meter's results with laboratory results periodically.
The results of the Sejoy UA-105 meter are plasma equivalent. This method
• If your uric acid is below 297umol/L( 5 mg/dL), your results generally
should fall within 60umol/L (±1 mg/dL) of the laboratory result.
• If your uric acid is equal to or over 297umol/L( 5 mg/dL), your results
generally should fall within ±20 % of the laboratory result.
To maximize your chances of an accurate comparison between meter
and laboratory results, please follow a few basic guidelines:
Before going to the lab
• Perform a control solution test to make sure the meter is working
properly.
While at the lab
• Conduct your meter test of the lab test within 15 minutes.
• Use only fresh, capillary blood obtained from the fingertip.
• Follow all instructions in this Owner’s Booklet to performing a uric
acid test by your meter.
will help you and your healthcare professional compare your meter results
with laboratory test results. The Sejoy UA-105 meter's test result and laboratory
test results both are expressed in plasma-equivalent units. However, your
uric acid meter result may differ from your laboratory result due to normal
variation. Your uric acid meter results can be affected by factors and conditions
that do not affect laboratory results in the same way.
• Do Not eat for at least eight hours before you test your uric acid.
• Take the meter to the lab
22
Memory and averages
Storing uric acid and Control Test results
① Entering Memory Mode
Start with the meter off (no test strip inserted). Press and release the “M”
button to enter memory mode.
② Viewing previous memory in order
Press and release “M” button to scroll forward to all
results. Your most recent result will display first.
Note: If there is no test result stored, the meter will
display “ ” for a few seconds then automatically
turn off.
The meter automatically stores up to 360 uric acid test results with the
time and date of the test and any test markers. Results can be reviewed
at any time. Test results are stored from the newest to
the time and date correctly in the meter. Having the correct time and date
setting helps ensure appropriate interpretation of stored uric acid results
by you and your healthcare professional.
the oldest, so set
23
o
Memory and averages
Exiting
In memory mode, press and hold the “M” button for few seconds until the
meter turns off.
Viewing7-, 14-, 28-day average
Press and release “S” button to scroll forward to
averages.
The first memory display screen you see is your
7-day average.
This average includes all the readings from the
last period days.
n = indicates the number of results
included in your average
Deleting all memory
Press and hold “S” button approximately 3 seconds.
After memory cleared, the meter will display “dEL” for
aprrox. 3 minutes, and then automatically turns off.
③
④
⑤
24
o
Control solution testing
When to perform a control test
Control Solution contains a known amount of uric acid and is used to
check that the meter and the test strips are working properly.
Do a control solution test:
• Whenever you open a new vial of test strips.
• Whenever you want to check if you are testing correctly
• If you suspect the meter and test strips are not working properly.
• If you have had repeated unexpected uric acid results.
• If you drop or damage the meter.
• If you left the test strip container open or you think the test strips
have been damaged
• If the test strips were stored in extreme temperatures and/or humidity
• Your test result does not match how you feel
NOTE:
• Only use the Sejoy CS-301 control solution.
• Close the control solution bottle tightly after use
• Write the date you open the control solution bottle on the bottle label.
The control solution must be discarded 3 months from the date the
first open date or the expire date on the vial label, whichever comes
first.
• Do not use control solution that is past the Exp. Date or discard date.
• Refer to the control solution label for control solution storage
conditions.
• The control solution can stain fabric. Remove stains by washing with
soap and water.
CAUTION: Do Not swallow control solution. It is not for human
consumption. Do Not apply control solution to the skin or eyes
as it may cause irritation.
25
Control solution testing
Performing a control test
① Insert a test strip to turn the meter on
② System check screen
Each time the meter powers on, this screen briefly
appears so that you can make sure the display is
working properly.
③ The blood drop symbol flashes on the display screen.
Your meter is now ready to apply blood sample.
④ Shake the control solution vial before each test.
Remove the cap and squeeze the vial to discard the first
drop. Then wipe the tip with a clean tissue or cloth. Hold
the vial upside down and gently squeeze a hanging drop.
26
o
Control solution testing
Performing a control test
⑤ Touch and hold the hanging drop of control
solution where the narrow channel meets the
TOP EDGE of the test strip. Make sure the
confirmation window fills completely. Control
solution should not be applied to the flat face of
the test strip.
CONFIRMATION
WINDOW
⑥ Read the result on the meter
When the confirmation window is full, the meter will
count down from 20 to 1. uric acid level appears
on the display, along with the unit of measure, the
date and time of the test.
The results are automatically stored in the meter’s
memory.
TOP
EDGE
NARROW CHANNEL
Apply Drop Here
27
o
Control solution testing
Understanding out-of-range control test results
Compare the result displayed on the meter
to the control solution range printed on the
test strip vial. Each vial of test strips may
have a different control solution range. If
the results you get are not within this range,
the meter and test strips may not be working
properly. Repeat the control solution test.
Out-of-range results may be due to:
• not following the instructions detailed in steps 1–6
• expired or contaminated control solution
• expired or damaged test strip
• use of a test strip or control solution passed its discard date
• a problem with the meter.
CAUTION: The control solution range printed on the test strip
vial is for Sejoy Control Solution only. It is not a recommended
range for your uric acid level.
CAUTION: If you continue to get control solution test results
that fall outside the range printed on the test strip vial, Do Not use
the meter, the test strips, or the control solution. Contact the
vendor.
xxx–xxx umol/L
xxx–xxx
xxx–xxx
CTRL
LOT：
Expiration date ：
Frist open date ：
umol/L
mg/dl
(Example)
28
Control solution testing
⑦ Delete the memory
If you don’t want to keep the test result, press the “S”
and “M” button to delete it at the same time. After
memory cleared, the meter will display “dEL” about 3
minutes, and then automatically turns off.
⑧ To turn your meter off, simply remove the test
strip. Carefully dispose of the used test strip.
29
o
Maintenance
Replacing the battery
Your meter comes with two preinstalled, 1.5 volt, type AAA, alkaline
battery. The battery provides enough power for the meter to perform
about 1000 tests. If your battery runs low, the battery symbol
appears on every display screen until you change the battery.
Important: When this symbol appears, you should replace the battery
immediately.
① With the meter off, open the battery cover.
② Remove the old batteries and place the new
ones in the battery compartment.
③ Put the battery cover back into position until it
locks into place.
④ Check your meter settings
Replacing the battery does not affect your stored
results. However, you may need to re-set your
meter settings. See Setting Up Your Meter section.
Note: Batteries need to be properly disposed of. Contact
your local government for disposal or recycling practices
in your area.
“
”
30
Maintenance
Caring for your system
Avoid getting dirt, dust, blood, control solution, water, or any other liquid
in the meter’s test strip port.
Important: Never immerse the meter in water or any other liquid. This
may cause inaccurate reading or meter malfunction.
Storing your system
Store your meter, test strips, control solution and other items in your
carrying case after each use. Store each item in a cool, dry place.
Do Not refrigerate. Keep all items away from direct sunlight and heat.
Tightly close the cap on the test strip vial and/or control solution vial
immediately after use to avoid contamination or damage. Store test
strips only in their original vial.
Checking for expiration or damages to test strips and control
solution
Expiration dates for test strips and control solutions are printed on
their vial labels. When you first open a new vial of test strips or control
solution, record the discard date on the label. Refer to the test strip or
control solution vial for instructions on determining the discard date.
-20℃~ 55℃( -4℉~131℉).
Cleaning and disinfection
Cleaning and disinfection are different, both of them should be performed.
Cleaning is a part of normal care and maintenance that should be
performed prior to disinfection, but cleaning does not kill germs.
Disinfection is a important way to reduce your exposure to disease.
Even though you are the only person who use it,
Test strips and control solution should be stored between 1℃~ 30℃
( 33.8℉~86℉).Meter and other items should be stored between
31
Maintenance
Cleaning your meter and lancing device
To clean your meter and lancing device, wipe the outside with a soft
cloth dampened with water and mild detergent. Do not use alcohol
or another solvent. Do not get any liquids, dirt, dust, blood, or control
solution inside the meter through the strip port. Never spray cleaning
solution on the meter or immerse it in any liquid. Do not immerse the
lancing device in any liquid.
Disinfecting your meter and lancing device
The meter and lancing device should be disinfected periodically.
Clean your meter and lancing device prior to disinfecting.
To disinfect, prepare a solution of 1 part household bleach and 9 parts
water. Hold the meter with the strip port and pointed down. Use a soft
cloth dampened with this solution to wipe the outside of the meter and
lancing device until the surface is damp. Be sure to squeeze out any
excess liquid before you wipe the meter.
After wiping, cover the surface you are disinfecting with the soft cloth
dampened with the bleach solution for 1 minute. Then wipe with a clean
damp soft cloth and allow to air dry.
Wash hands thoroughly with soap and water after handling the meter
and lancing device.
we recommend to disinfect periodically.When you assist others to make
uric acid testing, If you take the meter,please disinfect it or wear gloves to
protect yourself.
32
Troubleshooting
Message
Possible Cause
What to do
The test strip may be
used or damaged.
The sample was
applied before the
meter was ready. .
Retest with a new strip.
The system check
may be failed
The test strip may be
moved during testing
The strip check
has problem.
Repeat with a new strip.
Remove the battery and
reinsert it after 30 seconds.
If it still doesn’t work,
please contact the vendor.
Retest with a new strip. Make
sure that the method of
applying sample is correct,
and test strip can not be
moved during testing.
Applying blood after the
screen.
or sampling data is
unstable.
Retest with a new strip.
symbol flashes on the
33
Troubleshooting
Battery power is low.
The meter is out of
operating temperature
range.
Replace the battery soon
Place the system in
appropriate operating
environment for 30
minutes before retesting.
34
Contact the vendor.
Contact the vendor.
Meter does not enter the test mode after inserting a test strip.
Probable Cause
What to Do
Replace the battery (and reset the date and
time,if necessary.)
The battery is installed
incorrectly or there is no
battery in the meter.
Check that the battery is installed correctly.
Test strip inserted upside
down, or
incompletely inserted
into the meter.
Insert the test strip with the
printed side up
Defective meter or test strips.
Contact the vendor.
Blood or foreign objects put
into the test strip port.
Test does not start after applying the blood sample.
Probable Cause
What to Do
Defective test strip.
Repeat the test with a new test strip.
Sample applied after meter
times out and
turns off.
Defective meter or test strips.
Troubleshooting
meter.
and the top of the strip in the
Remove the test strip, and repeat the test using
test strip symbols on the display screen before
you apply the blood sample.
a new test strip. Wait until you see the blood and
35
Battery power is low.
Technical information
Specifications
Product description
Assay method
Measurement range
Sample
Unit of measure
Memory
Size
UA-105 Uric Acid Monitoring System
Uric acid electrochemical biosensor
180-1190 umol/L (3~20 mg/dL)
Fresh capillary whole blood from the finger
20 seconds
Coding
2 X AAA alkaline battery, replaceable
Approximately 1,000 tests
umol/L or mg/dL; switchable
360 uric acid results with date and time
106.5*66.5*21.5 mm (L*W*H)
Sample size
Response time
Coding
Battery
Battery life
Calibration
Plasma equivalent uric acid values
≥1.5ul
36
LCD size
41.8*41.8 mm (L*H)
Technical information
Specifications
Weight
Operating environment
Meter storage environment
Hematocrit
Altitude
Automatic power off
Approximate 68g, battery not included
10℃～40℃(50℉～104℉)
10 ~ 90% RH (non-condensing)
-20℃~ 55℃ ( -4℉~131℉)
30%~55 %
Up to 10,000 feet (3,048 meters)
above sea level
Approx. 3 minutes after last user action
10 ~ 95% RH (non-condensing)
Electromagnetic Compatibility
The chosen basis for electrostatic discharge immunity testing
emissions requirements as standrard EN 61326.Its electromagnetic emission
is thus low.Interference from the meter to other electrically-driven equipment
is not anticipated.
was basic standard EN61326.In addition.it meets the electromagnetic
37
Strip storage environment
1℃~ 30℃ (33.8℉~86℉)
Expected service life Three years
Disposing of the meter, test strips, lancets and batteries
Warning
• Any product coming in contact with blood is considered contaminated
(potentially infectious).
• During normal testing, any uric acid meter may come in contact
blood.
• Lancing devices may also be considered sharps. Disposal of sharps
is regulated by law in many jurisdictions.
Comply with any laws or ordinances relating to the disposal of sharps
and/or contaminated products. Contact your local health department
or other appropriate authorities for proper handling and disposal of
used meters, used test strips, used lancets, and used batteries.
Please consider the following points when disposing of used testing
materials:
• Consider recycling of the meters and batteries at an appropriate
facility. Be aware the meter is potentially hazardous electronics
scrap (e-scrap) and should be disposed of accordingly. The batteries
are potentially hazardous also and should be disposed of accordingly.
• Disinfect the meter before recycling or disposing.
* 29 CFR 1910.1030 – Bloodborne pathogens
* Directive 2002/96/EC – Directive on waste electrical and electronic
equipment (WEEE)
with
39
37 36
39
37 38
Warranty
Limited 2-Year Warranty
The meter is guaranteed for 2-year from the date of purchase. If the
meter does not function properly due to defective components or poor
workmanship, we will repair or replace it freely. This warranty does not
cover damage due to improper handling in any way. Battery does not
included in the warranty.
39
Traceability
The accuracy of UA-105 uric acid system is compared with the results by
testing fingertip whole blood or venous blood and the results by testing the
calibration product used Mindray biochemical analyzer. The traceability
material of the calibration product trace to NIST SRM 913a, and the
reference method of Mindray biochemical analyzer is NIST definitive
method of ID-LC/MS/MS.
40
Performance Characteristics
The per formance of the system has been evaluated both in laboratory and
in clinical tests.
Range: The display range of the meter is 180umol/L to 1190 umol/L
(3mg/dL to 20 mg/dL). "HI" and "Lo" messages indicate results
outside of this range.
• Accuracy: The accuracy of the system was assessed by comparing
uric acid results obtained using Mindray Chemistry Analyzer, a
laboratoryinstrument.
Table1. System accuracy results for uric acid concentration<297umol/L
Table2. System accuracy results for uric acid concentration ≥297umol/L
Within ±60 umol/L
126/126(100%)
If the uric acid is below 297umol/L(5mg/dL), the results generally
should fall within 60umol/L (1 mg/dL) of the laboratory result.
If the uric acid is equal to or over 297umol/L（5mg/dL), the results
generally should fall within ±20 % of the laboratory result.
Bias
Percentage
(Within ±1mg/dl)
41
Within ±5 % Within ±10 %
92.2%(437/474)
Within ±15 %
Within ±20 %
99.4%(471/474) 100%(474/474)
57.0%(270/474)
To maximize your chances of an accurate comparison between meter
and laboratory results, follow a few basic guidelines:
Before going to the lab
·Perform a control solution test to make sure the meter is working properly.
·Do Not eat for at least eight hours before you test your blood.
·Take your meter with you to the lab.
Performance Characteristics
y-intercept 24.087
correlation coefficient(R²) 0.9768
Precision:
272.6 430.6 532.6 709.4 928.9
SD(umol/L) 16.8 20.3 25.4 28.8 37.7
CV(%) 6.2% 4.7% 4.8% 4.1% 4.1%
Slope 0.9493
42
Average
concentrarion(umol/L)
Symbol Index
SN
∑
Consult instructions for use
In vitro diagnostic medical device
Serial number
Batch code
Manufacturer
Contain sufficient for < n > tests
Caution
Do not reuse
Use by
Storage temperature limitation
43
Symbol Index
0123
The product conforms to the requirements of the
CE mark in vitro diagnostic medical devices
44
Biological risks
Keep dry
This symbol indicates that you should not discard
waste electrical or electronic equipment (WEEE)
in the trash. For proper disposal, contactyour local
Direct Current
European Authorized Representative
EC
REP
0197
1.Kim EK, Waddel LD, Sundedrland MLE et al. Obser- vations on
Diagnostic Kits for the Determination of Uric Acid. Clin Biochem.
1971, 4:279 ~286.
2. Fossati P. et al., Clin. Chem. 26/2, 227(1980) Thefeld, L.et al,
Dtsch.
Hangzhou Sejoy Electronics & Instruments Co., Ltd.
AreaC,Building2,No.365,WuzhouRoad,Yuhang
Economic Development Zone, HangzhouCity311100
ZhejiangChina.
EC
REP
Document No.: DUA-0104-002
Version:Z
Date of Issue: 2019.02.02
Shanghai International Holding Corp.Gmbh (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
