URIT 12 Operation Manual

CONTENT

Chapter 1: Introduction..............................1

Chapter 2: Technical Specifications...........5

Chapter 3: Principal of Operation...............6

Chapter 4: Blood Sample Collection..........7

Chapter 5: Appearance and Function........8

Chapter 6: Setting......................................9

Chapter 7: Operation...............................15

Chapter 8: Trouble-shooting....................20

Chapter 9: Maintenance..........................23

Chapter 10: Meaning of Marks.................25

Chapter 1: Introduction

URIT-12 Hemoglobin Meter is designe­d for use only with H12 Hemoglobin Test
Strip from URIT Medical Electronic Co., Ltd.,
for the quantitative measurement of hemo­globin in capillary and venous whole blood.

According to the conversion between
normal average hemoglobin concentration
and haematocrit(HCT), URIT-12 Hemoglo­bin Meter can obtain the hint of HCT base
on determined hemoglobin concentration.
Hemoglobin is the oxygen-carrying protein
in red blood cells. The quantitative measur­ement of hemoglobin is indicated and clini­cally useful in acute illness as well as in
general care. The normal range hemoglobi­n values reported in medical literature are
gender and age dependent:

Adult males 13.5~18.0 g/dL.

Adult females 12.0~16.0 g/dL.

Infants Ranging from 14.5

~22.5g/dL after birth

to 11.1~14.1g/dL at
6 months old.

Children Gradually increase

from infant to adult
levels.

Low hemoglobin levels may indicate
condition such as anemia or hemorrhage.
Elevated hemoglobin levels may indicate
conditions such as polycythemia. A hemog­lobin test may be used as part of a general
screen for many types of patient populatio­ns, including the elderly, children, and
women of child-bearing age, and prior to
giving or receiving transfusions. Due to diff­erences among patient populations, we
recommend that each clinical site establish
its own reference ranges.

People use Hemoglobin Meter with the
whole blood for local inspection or tending,
which is helpful for evaluating patients’ sy­mptom quickly and providing proper treatm-

ent determination.

When test result is different from clinic­al symptom, repeat test. If there are still so­me problems, validate it by control or com­pare hemoglobin test methods with that of
other labs.

Judge the clinical signification of test
result by following the doctor’s direction.
Prior to any medication, treatment should
be provided by doctor based on test result
and clinical symptom.

Warning:

Please read this manual carefully befo­re using URIT-12 Hemoglobin Meter.

1. URIT-12 Hemoglobin Meter is for

in vitro diagnostic use only.

2. Insufficient blood sample volume
and inadequate mixing of EDTA-treated
samples may affect results.

3. URIT-12 Hemoglobin Meter is des­igned for use only with H12 Hemoglobin

Test Strips from URIT Medical Electronic
Co., Ltd. Prior to the first use of test strips,
read the manual carefully and input the Lot
Code to the meter.

4. As all diagnostic tests, test results
should be evaluated according to the speci­fic patient’s condition. Any results demonst­rating the inconsistency with the patient’s
clinical status should be repeated or suppl­emented with additional test data.

5. In order to test the hemoglobin ac­curately, please use and maintain the meter
correctly. Review this manual before the fir­st time using the meter.

6. While the test is in progress, do not
disturb or move the meter or strip, even pr­ess any key.

7. Over strong electromagnetic field
will disturb its work. We recommend you to
keep the distance between meter and micr­owave oven over 2 meters when you test in
the room.

8. Over high temperature and humidi­ty will affect its working. We recommend
you not to use it in the sauna or bathroom.

9. Use it at the temperature of 15℃~
30℃.

10. When equipment is at work, please
do not look directly at light source.

11. Avoid any liquid permeating the m­eter anytime.

Chapter 2: Technical Specifications

Parameter: Hemoglobin in fresh whole
blood.

Measuring Principle: Optical reflectance.
Strip: H12 Hemoglobin Test Strips.
Measuring time: Less than 12 seconds.
Haematocrit (HCT) hint: Display in perce-

ntage.
Measuring range: 4.0g/dL~24.0g/dL. Res­ults under 4.0g/dL or over 24.0g/dL will dis­play as “Lo” or “Hi” respectively so as to in­dicate the result which is out of range.
Display: LCD, test results display in SI.

Storage function: Save the strip code,
memorize and update 250 test results
automatically.

Correction function: self-correction.
Weight: < 58g (Battery included).
Outer dimension: 102mm×50mm×19mm.
Power: DC 6V (Two CR2032 Battery).
Operating Ranges: 15~30℃;RH≤80% non

-condensing.
Ultimate Ranges: -20~55℃;RH<90% non-
condensing.

Others: Internal trouble check and display.
Available life: 8 years.

Chapter 3: Principal of Operation

The hemoglobin meter utilizes optical
reflectance for determination of the total
hemoglobin. The test strip is inserted into
the meter when prompted, a background
blank reading is automatically determined.
A drop of whole blood is applied to the test

spot on the strip, blood immediately disper­ses within the membrane, contacting the
reagent, then reaction product could absor­b spectrum in the range of 500nm-600nm.
The meter’s optical detector automatically
measure the change in membrane reflecta­nce. The intensity of reflectance is inversely
proportional to the hemoglobin concentrati­on. The meter calculates and displays the
total hemoglobin concentration in gram/de­ciliter (g/dL) in 12 seconds based on a mat­hematical conversion.

Chapter 4: Blood Sample Collection

1. Fresh capillary or EDTA-anticoagulate­d venous whole blood may be used.

2. If an EDTA-treated sample is refrigera­ted, allow it to come to room temperature
prior to use. EDTA-treated blood samples
should be mixed using end to end inversio­ns at least 8 times prior to use, and should
be tested within 24 hours.

3. For fresh venous whole blood samples,
collect approximately 0.1mL into an antico­agulant-free plastic syringe.

Chapter 5: Appearance and function

1. Appearance:

The meter is composed of keys, LCD,
circuitry board, optical system, strip holder,
cover and battery. See the picture of appe­arance as below:

2. Function:
Power switch: Turn meter on and confirm

key (turning meter off is confirmation)

▲key: up
▼key: down

Strip holder: hold strips
SET key: set function (under the strip hold-

er, refer to Chapter 6)

Chapter 6: Setting

1. Meter Options Setting

Before the first time using URIT-12
Hemoglobin Meter, the user must enter the
following settings:

• Time and date format.

• Current time and date.

2. Entering Settings

Step 1: Lift the test strip holder off the met­er.
Step 2: Turn the meter on by pressing the
Power switch key. Wait until the meter dis­plays the Lot Code, time and date.

Now the meter can be customized for
time and date format, current time and dat­e.

3. Time and Date Format:

The user can select both display time

and date in a 12-hour AM/PM time clock
with mm/dd date format or in a 24-hour time
clock with dd/mm date format.

Note: The date format only contains day
and month, not including year.
Step 1: Press the SET key once, the date
and time will display. Press and hold the
SET key again until the time and date flash.

Step 2: Press the ▲ or ▼ key to select date

format.

Step 3: Pressing the SET key as step 1 and
2 to enter the current time and date. If ente­ring the current time and date is not requir­ed, and then turn the meter off to confirm
the selected time and date format.

Note: Once confirmed, the time and
date format will be changed for all stored
test results.

4. Entering Current Time and Date:

The user must enter the current time
and date for correct stamping of test results.
If proceeding from Select Time and Date
Format instructions above, go directly to
Step 2. Otherwise, start from Step 1.
Step 1: Press and hold the SET key until
the time and date flash. Press the SET key
again.
Step 2: The hour (with AM/PM if 12 hr form-

at selected) will flash. Press the ▲ or ▼

key to enter the hour. Press the SET key to
confirm.

Step 3: The minute will now flash. Press the

▲ or ▼ key to enter the minute. Press the

SET key to confirm.
Step 4: The first date selection will flash (m-
m or dd). Press the ▲ or ▼ key to enter
the first date selection. Press the SET key
to confirm.
Step 5: The second date selection will flash
(dd or mm). Press the ▲ or ▼ key to enter
the second date selection. Press the SET
key to confirm.
Step 6: Turn the meter off to confirm the
entering time and date.

Note: Once confirmed, the reporting un-

it will be changed for all stored test results.

Once selection of meter settings has
been completed, replace the strip holder
onto meter.

5. Saving Test Results

URIT-12 Hemoglobin Meter automatic­ally stores 250 test results with a date and

time. If the storage is more than 250 test
results, the oldest test result would be auto­matically erased. Test results are stored in
ascending chronological order: The first te­st result on the screen (sequence 001) is
the newest test result, and the last one (up
to sequence 250) is the oldest test result. A
test result will store automatically when the
meter shuts off (both by pressing the key or
automatic shutoff after two minutes of inact­ivity).

6. Viewing Saved Test Results

Step 1: Turn the meter on by pressing the
Power switch key. Wait until the meter dis­plays the Lot Code, time and date. Press
the ▲ key to display the test result and its
sequence number (a flashing MEM will
display to the lower left of the test result).
After releasing the key, the test result with
its time and date, and a flashing MEM will
display.

Step 2: Continue pressing the ▲ or ▼ key

to scroll through test results.
Step 3: Turn meter off to exit this function.

7. Deleting Test Results

Test results could be deleted by follow­ing two methods: deleting the recent results
by CLE or deleting all results by CLA.

User could turn the meter off to stop
deleting test results before MEM displays.
Step 1: Lift the strip holder, turn the meter
on. Wait until the meter displays the Lot Co­de, time and date.
Step 2: Press SET key twice, CLE displays.
Delete the recent results:
Step 3: Continue pressing SET key till CLE
flashes. Release SET key, the last result
will display. To delete this result, keep hold­ing SET key and the result will flash and
then be deleted.

Delete all results:

Step4: Press SET key one more time, CLA
will display. Hold pressing SET key, CLA
flashes, Release SET key, ALL will display.

Continue pressing SET key, all the results
will be changed into MEM ---.

After completing all steps, turn off the
meter and cover the strip holder.

Note:If you want to exit CLE witho- ut
deleting test results, you can shut off the
meter directly.

Chapter 7: Operation

1. Turn the meter on

Press the Power switch key to turn th-
e meter on. The meter automatically monit­ors its internal circuitry and components du­ring a brief self-check. The meter is ready
when the test strip prompts, Lot Code and
time/date are displayed.

Note: To conserve the battery, the met­er will automatically shut off after 2 minutes
of inactivity. If this happens, turn the meter
on again.

2. Input Lot Code of the Test Strip

Input the lot code as follows:

1) Press the Power switch to turn the met­er OFF.

2) Insert the code card correctly into the C-
ode slot. Press the Power switch to turn
the meter ON, the meter will read the code
card automatically and display the code on

the screen. The meter will automatically
turn OFF.

3) Remove the code card. Turn the meter
ON again. Please verify the displayed code
is match the code printed in the label of
container which the test strips will be taken
from.

3. Prepare for a Finger stick

Make sure the patient’s hand is warm
and relaxed. Massage the patient’s middle
or ring finger from the knuckle up to the tip
to stimulate blood flow. Clean the sample
area with alcohol and wipe dry with a sterile
gauze pad.

4. Prepare the Test Strip

Take a test strip from its container. Ex­amine the test strip. Do not use if there are
tears, wrinkles or debris. Do not touch the
test spot membrane. Reseal remaining test
strips in the original container.

5. Insert the Test Strip

Insert the test strip into the strip holder

with the notched end in first and the hole fa­cing up. The notched end on the top of the
strip should no longer be visible when the
test strip is inserted correctly and fully.

6. Prepare the Meter for Sample Applica-

tion

The meter will automatically perform a
background blank reading. It will display a
flashing prompt to indicate that it is ready to
test a sample. The meter will allow 2 minut­es for application of the blood sample.

7. Perform a Finger stick

Incise the underside of the fingertip. A­void “Milking”. Apply light pressure to obtain
one drop of blood.

8. Apply Blood Sample to the Test Strip

Immediately apply a drop of blood to
the test strip by touching the hanging blood
drop to the test spot, ensure the blood drop
is large enough to completely cover the test
spot. A capillary transfer pipe may also be
used to transfer the blood sample from the

finger to the test strip.

Note: This product is used for test-
ing human blood, user must prevent again­st possible blood infection.

l A drop of blood (refer to the instru-

ction of Strips for detail)

l Do not use strip to touch blood,
test strip must be fixed on the meter. Apply
only the hanging blood to the test spot.

l Do not touch directly the test spot
membrane by finger.

l Do not apply superfluous blood;
the volume just covering the spot complete­ly is enough.

l Do not apply blood on the spot ob-
taining blood repetitiously. Each strip is us­ed for one test.

9. Read Result

The blood sample will spread and the
meter will automatically begin the test. Dur­ing the test, do not disturb or move the met-

er or strip, even press any key of meter.

The test result will be displayed in less
than 30 seconds.

After the test is completed, remove the
test strip and check whether the test strip s­pot is covered by blood sample completely
or not. Otherwise, the test result is not acc­urate, please test again.

After the test is finished, the meter will
automatically shut off after 2 minutes of ina­ctivity, or can be turned off by pressing the
Power switch key. The test result will be
stored automatically with its date and time.

10. Disposal

The waste should be disposed strictly
according to reference requirement of local
Medical Sanitary Management Department.
Do not throw it optionally.

11. Reportable range

The reportable range for hemoglobin is
from 4.0 g/dL to 24.0 g/dL. Results under 4.
0g/dL or over 24.0 g/dL will display as “Lo”

or “Hi” respectively to indicate the result out
of range.

Chapter 8: Trouble-shooting

Troublecode&
phenomenon

Possible Cause Correction

Hardware or
software error

Turn off and on again.
If the error still exists,
please contact the local
distributor.

E0, E1

Meter used in
bright sunlig­ht

Bright sunlight disturbs
optical system of meter.
Used it in room-light or
shade. Turn off and on
again. Repeat test with
new test strip.

E2

Temperature
out of Range

Allow meter to adjust to
temperature declared in
the Manual and wait un­til it shake down. Turn
off and on again. Repe­at test with new test
strip.

Removing the
strip with sa­mple before t­esting

Do not remove test strip
till finishing the test.
Turn off and on again.
Repeat test with new

test strip.
Insufficient
Sample
Volume

Remove the test strip

and shut off. Turn on

and repeat test with new

strip. Confirm the blood

is sufficient.
Strip is
damaged

Remove the test strip

and shut off. Turn on

and repeat test with new

strip. Confirm there are

not tears, wrinkles or

debris.
Incorrect

blood sample

Do not use other blood

sample, such as plasma.

Repeat test with the

correct blood sample:

fresh or EDTA-anticoa-

gulated whole blood.

Damaged
Strip Inserted

Remove the test strip

and shut off. Turn on

and repeat test with new

strip. Confirm there are

no tears, wrinkles or

debris.
Optical detec­tor needs cle­aning

Remove strip holder

and clean lenses follo-

wing the direction.
Optical detec­tor does not
read the back­ground blank

Before finishing the ba-

ckground blank reading,

do not apply blood sam-

ple. Do it until displayi-

ng a flashing prompt.

E4

Optical detec­tor is clogged

Check the Optical dete-

ctor, whether it is cove-

red by blood or others,

if yes, remove the strip

holder and clean it. Ref-

er to the Manual.

Used strip
Inserted

Remove the test strip

and shut off. Turn on

and repeat test with new

strip.
Inserted strip
error

Review the instruction

of Insert Strip. Remove

the test strip and shut

off. Turn on and repeat

test with new strip.
Set strip
holder error

Remove strip holder

and reset. Push it to the

end. Do not use if it is

loose or skew.
Replace

battery

Replace battery referri-

ng to the Manual. Immediately sh-

ut off once turn
on or during the
operation proce­ss

Move the stri­p during the
test

The meter will turn off

automatically in 4 seco-

nds if the strip is move-

d. Repeat test with new

strip.

Chapter 9: Maintenance

1. Routine maintenance and cleaning

The cleaning must be done after appl­ying superfluous blood sample every time.
Hold the bottom of meter with left hand and
lift holder, then the strip holder could be re­moved and cleaned. Wipe away the rest
blood or dirt left on the holder or meter usi­ng gauze with disinfectant (diluenting 10%
home bleacher, about 0.6% hypochlorite).

If there is superfluous blood on the op­tical detector, clean it by cotton sticker with
little detergent. Wipe the strip holder and
optical detector completely by cotton cloth
without hemp. Avoid any liquid permeating
the meter anytime.

Do not polish the surface of optical det­ector with any polished or corrosive deterg­ent to avoid the damage of meter and optic-

al detector. After cleaning, put the strip hol­der and display in a level, and press arc se­gment, the holder could be set back.

2. Battery replacement

Open the battery cover, take the batte­ry out of gap, replace two new CR2032 bat­tery, cathode is facing down, insert it into
battery container, and press it down, close
the cover.

Chapter 10: Meaning of Markings

In vitro diagnostic medical device
Caution! Refer to accompanying

documents

Biological Hazard

Serial number

Direct current

Use CR2032 as power supply

Manufacturer

Authorized representative in the

European Community

Recovery

Protect from heat and radioactive

sources

This product fulfils the requirements of

Directive 98/79/EC on in vitro iagnostic
medical devices

Supplied by:

URIT Medical Electronic Co., Ltd.

Ver No: 07/2010-5

Wellkang Ltd t/a Wellkang Tech Consulting
Suite B, 29 Harley Street, LONDON W1G 9QR, UK