URIT Medical Electronic PFS-30 User manual

URIT
PFS-30/PFS-30A
Blood Lipid Analyzer
OPERATION MANUAL
URIT Medical Electronic Co., Ltd.

Contents
1. Warnings..........................................................................................................................................1
2. Brief Introduction............................................................................................................................3
2.1 Product Name........................................................................................................................3
2.2 Specifications and Models................................................................................................3
2.3 Assorted Test Strip.............................................................................................................3
2.4 Sample requirements........................................................................................................ 3
2.5 Intended Use...................................................................................................................... 3
2.6 Contraindications............................................................................................................... 3
2.7 Packaging & Components................................................................................................3
2.8 Operation Principles.......................................................................................................... 5
3. Operating Instructions.....................................................................................................................6
3.1 Installation and Change of Batteries.............................................................................. 6
3.2 Buttons.................................................................................................................................6
3.3 Display Information............................................................................................................7
3.4 Settings................................................................................................................................7
3.5 Code.....................................................................................................................................9
3.6 Detection of Blood Lipid..................................................................................................10
3.7 Data Communication.......................................................................................................13
3.8 Management of Saving Data......................................................................................... 13
3.9 CHD Risk Evaluation.......................................................................................................16
4. Systemic Performance Data.......................................................................................................... 20
4.1 Accuracy............................................................................................................................ 20
4.2 Precision............................................................................................................................20
5. Errors & Troubleshooting............................................................................................................. 21
6. Maintenance & Care of analyzer.................................................................................................. 22
7. Technical Paraanalyzers................................................................................................................ 23
8. Symbols......................................................................................................................................... 24
9. Basic Information..........................................................................................................................25
10. RED DoC.................................................................................................................................... 26

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1. Warnings
(1) Before using the analyzer, please be sure to read the product Operation Manual, please
be sure to as stipulated in the manufacturer of ways to use analyzer, otherwise it may
cause the analyzer's protective destroyed, at the same time, please pay special attention
to the instrument identification there is symbol, please refer to the attached
documents in time, in order to know the potential risk nature and any measures must
be taken.
(2) Danger - the wrong use of the blood lipid analyzer may cause fire and burn.
(3) This product is only used for external monitoring and cannot be used as a tool to
diagnose coronary heart disease or hyperlipidemia.Please judge the clinical significance
of the test results under the guidance of your doctor..
(4) Please correctly use the code card that matches the blood lipid test strip.
(5) This blood lipid analyzer is only used with the corresponding blood lipid test strip.
(6) Do not use test kits that are not provided or recommended by the manufacturer, as this
will inevitably lead to incorrect measurements.
(7) If there is any trouble that cannot be eliminated, please contact the seller or
manufacturer to solve it. Do not disassemble the analyzer by yourself.
(8) Keep the analyzer away from children and pets.
(9) Avoid the analyzer in high temperature and humid environment, and avoid contact with
dust, salt, sulfur and other substances.
(10) Do not put the analyzer in a liquid, do not put it in a place where it might fall into the
liquid, do not put the analyzer in a wet or splashing place.
(11) Do not place anything on top of the device.
(12) Do not use the analyzer where aerosol droplets are present.
(13) Do not allow the instrument to touch a surface that is too hot to touch.
(14) Do not touch the sample area of the test strip to prevent contamination of the sample
area.
(15) Before use, please do not use the test bar if it is found that the structure of the test strip
is damaged or the sample area is obviously stained.
(16) Please check the production batch number before using the test strip If it has expired,
please do not use it again.
(17) Do not press or move the blood lipid analyzer or test strip during the test.
(18) Avoid testing in places other than the environment specified by the instructions.
(19) Avoid direct exposure to strong light when using equipment indoors.
(20) Do not drop anything into or into the opening of the device other than the applicable
test strip.
(21) The Meter is designed according with EN 61326-2-6-2013, “measurement, control and
laboratory use of electrical equipment - EMC requirements - part 2-6: special
requirements - in vitro diagnostic (IVD) medical equipment ”and IEC 61010-1-2010,
“safety requirements for electrical equipment for measurement, control, and
laboratory use -- part 1: general requirements”.
(22) Do not use this instrument in close proximity to sources of strong electromagnetic
radiation, as these may interfere with the proper operation.

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(23) If this equipment is used in a medical institution, it is recommended to evaluate the
electromagnetic environment before operating the equipment.
(24) Use of this instrument in a dry environment, especially if synthetic materials are
present (synthetic clothing, carpets etc.) may cause damaging electrostatic discharges
that may cause erroneous results.
(25) Venous blood test should be performed by medical personnel and follow the relevant
operating rules of medical and health institutions

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2. Brief Introduction
2.1 Product Name
Blood Lipid Analyzer (hereinafter referred to as analyzer)
2.2 Specifications and Models
PFS-30 (with Bluetooth); PFS-30A
2.3 Assorted Test Strip
PFS 30 Blood Lipid Test Strip (produced by URIT)
2.4 Sample requirements
Sample type：whole blood (venous blood or capillary blood)
Sample collection and storage：
①The sample blood can only be added with heparin or EDTA for anticoagulation. Blood
sample that is added with any other anticoagulant should not be used for this analyzer.
②Blood sample which haven’t been treated with anticoagulants should be detected as soon
as possible, while blood samples which have been added with anticoagulants should be detected in
8 hours. Hemolytic specimens can result in inaccurate results.
③Blood sample can be reserved under 2℃to 8℃and brought to room temperature before
test. The blood sample should be completely blended before test.
④Sample size: 35μL～40μL
2.5 Intended Use
Blood Lipid Analyzer and matched test strip is used to quantitative detection of total
cholesterol (TC), high-density lipoprotein cholesterol (HDL), triglyceride (TG) and low-density
lipoprotein cholesterol (LDL) in human whole blood (venous blood and capillary blood) sample,
as well as their ratios such as TC/HDL based on the above measurements. The analyzer is
intended to be used by lay persons and also can used by health care professional. It is suitable for
the daily blood lipids detection of people with abnormal or normal blood lipid, but not suitable for
neonatal testing. Test result of the product should not be used for diagnosis of cardiac vascular
diseases.
2.6 Contraindications
None
2.7 Packaging & Components
Unopened product should have the following items:
Standard Item
Quantity
Alternative
Item
Quantity
Blood Lipid analyzer
1
Portable printer
1
Operation Manual
1
If you’d like to purchase the alternative

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item, please consult local distributor.
Certificate of
Qualification
1
AAA Battery
3
Lancing Device
1
Product Components: This product is composed of the analyzer (main case, circuit board,
buttons and LCD display) , batteries and Lancing Device. The shape of analyzer is showed in the
following figure. Alternative items such as portable printer may be purchased by yourself.
The functions for each item of the analyzer are listed below:
①LCD Display: Display operating information and test results.
②(On/OFF Button): Press and hold this button to turn off the analyzer. This button can
also be used to select an item or confirm the selected item.
③M Button: When the analyzer is power off, a short press on this button can initiate the
inquiry screen as well as other operating functions.
④S Button: When the analyzer is power off, pressing and holding this button can initiate the
setting screen as well as other operating functions.
⑤Test Strip Slot: Insert the test strip into this place.
⑥Code Card Slot: Insert the code card into this place.
⑦Battery Cover: Fix batteries.
⑧Data Communication and Printer Connector: This connector is used to connect the
analyzer to computer for data communication or printer.
Figure 1 analyzer Front Figure 2. analyzer Back
The PFS-30 or PFS-30A Blood Lipid analyzer (hereinafter as referred to as analyzer) is used
to detect the content of total cholesterol (TC), high-density lipoprotein cholesterol (HDL),
triglyceride (TG) in human whole blood (venous blood and capillary blood) sample, as well as
their ratios such as TC/HDL and low-density lipoprotein cholesterol (LDL) based on the above
measurements. The analyzer can only be valid when used in combination with PFS 30 Blood
Lipid Test Strip which is also produced by URIT. This analyzer is intended to be used in medical
institutions.
The measuring system formed by this analyzer and test strips can quickly, accurately and

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easily detect blood lipid related measurements. In order to maintain the accuracy of test results,
make sure that you have followed the standard operating instructions and maintenance guidance of
this analyzer. Please read instructions for use carefully before using this machine. Otherwise,
inaccurate operating methods may lead to inaccurate test results or even unnecessary harm to the
operators as well as patients.
2.8 Operation Principles
Operation principles are described by the Figure 3:
Figure 3 Basic structural diagram
As an analytic machine, this analyzer is designed based on reflexion photometry, which
makes it possible to acquire the content of blood lipids under the control and measurement of
built-in microcomputer. Upon detection, operator should insert assorted test strip into the analyzer
following the instructions and the analyzer can automatically obtain the blank value of the test
strip. When the analyzer informs the operator for sampling, the operator can drop blood sample
onto the test area of the test strip. Chemicals generated by blood sample and test strip will generate
an absorption spectrum near 630nm wavelength, causing changes to optical reflexion coefficient
of the thin film on the test hole. In this way, we can introduce an incoming light into the test zone
and detect the intensity of reflected light using light intensity detection module. The lower the
light intensity detected, the higher the concentrate of detected substance, and vice versa. Therefore,
the computer can automatically calculate the concentrate measurement of blood lipid based
relationship between reflected light intensity and concentrate of detected substance. The calculated
result will be displayed on the LCD screen.

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3. Operating Instructions
3.1 Installation and Change of Batteries
3 AAA batteries are used to make the analyzer working. In order to save the power of
batteries, the analyzer will be automatically powered off when there have be no operations for 5
minutes.
Install the batteries following listed steps as showed in the figure below:
Open the battery case and reveal the empty chamber.
Insert the battery into the chamber correctly. The negative pole of the battery should be
inserted first and matches with the negative sign inside the chamber.
After 3 batteries are correctly inserted, close the battery cover.
Note: If you won’t use this analyzer for a long while (such as 1 month), please take the
batteries out.
Take the batteries out following listed steps as showed in the figure below:
Open the battery cover and reveal the empty chamber.
Press the positive pole and push towards the negative pole until the battery is taken out.
Close the battery cover.
Figure 4. Installation and Change of Batteries
3.2 Buttons
Each button has two operation modes: short press; press and hold.
Short press: press the button and immediately release it.
Press and hold: Press and hold the button for at least 2 seconds.
Note: In this instruction for use, all operations which haven’t been clearly
described as “press and hold” should be initiated by a short press.

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3.3 Display Information
Figure 5. Display Information
Meanings of displayed numbers or symbols:
1. Current date and time.
2. Test No.: An sequencing number of test item, which can be used for test result inquiry.
3. Test result :Test result after one detection and code when the analyzer is just turned on.
4. Detection Item: CHD, TC, HDL, TG, TC/HDL, LDL.
5. Saving Data: When this symbol occurs, the displayed number in the middle of the screen is
saved test information for earlier tests.
6. Code Indicator: When this symbol occurs, the displayed number in the middle of the screen
is the code.
7. Unit of Blood Pressure: mmHg.
8. Measurement Unit: Unit of test result. There are two type of units which can be selected:
mg/dL, mmol/L.
9. Battery Capacity: This symbol means that battery capacity is low and operators need to
replace batteries.
10. Test Strip Indicator: When this symbol is flashing, the operator needs to insert test strip.
11. Sampling Indicator: When this symbol is flashing, it’s an indication that the operator can
apply the blood sample.
12. Indicators to input patient history: Question mark, Gender, Smoking history, history of
myocardial infarction. Operators can select yes or no.
3.4 Settings
Set the paraanalyzers of the analyzer following listed steps below before you initiate the
detection.
3.4.1 Initiate Settings
When the analyzer is turned off, press and hold S Button, the analyzer will be turned on and
the settings screen will be displayed. Therefore you can select and enter different pages for more
settings, such as TIME Screen (date and time settings), CHD risk evaluation function and UNIT
Screen (unit settings). Press and hold the Button anytime when you want to save the changes
and turn off the analyzer.

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Note:
The detection time of every blood sample will be automatically recorded by the analyzer
for subsequent inquiry and statistical analysis. Thus in order to maintain the accuracy of
recorded time, when you have inserted an new code card or replaced the batteries, always
remember to check the date and time and make sure they are right.
This is because that when the batteries are taken out, all information about date and
time will be missing. Therefore, the analyzer will automatically display the setting screen of
TIME every time when it has been restarted or replaced for batteries. Follow the
instructions and make sure the date and time are correct.
3.4.2 Date and Time
The first setting page will be “TIME Screen” where you can edit the date and time. Press M
Button or S Button to input the data of “Year”. If the date and time are correct, press Button to
enter the next page of for settings of “CHD risk evaluation function”.
Figure 6. TIME Screen
When you press M or S button, the number indicating year will be flashing. Continue press
M Button to decrease the number or S Button to increase it. When the number of year has been set
correctly, press Button to save the change and move to next page for following settings:
month, day, hour, minute. The setting process is the same as setting the year.
Figure 7. Setting of Year
Set the accurate month, day, hour, and minute in turn following the same methods.

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Figure 8. Setting of Date and Time
When you have finished the settings of date and time, press Button to save the changes
and move along to the next page for CHD Risk Evaluation Function.
3.4.3 CHD Risk Evaluation Function
Press M Button or S Button to turn on or off the “CHD Risk Evaluation Function”. Press
Button to confirm current settings and move to the next page of “UNIT Screen”.
Figure 9. CHD Risk Evaluation Function is On Figure 10. CHD Risk Evaluation Function is Off
3.4.4 Unit Settings
Press M Button or S Button to switch the unit between “mg/dL” and “mmol/L”. Press
Button to confirm current settings and go back to the page of “TIME Screen”.
Figure 11. Set the unit as mg/dL Figure 12. Set the unit as mmol/L
3.5 Code
The codes of test strips from different batches are different, so the operator needs to set the
code before using the analyzer, otherwise the test results will be incorrect. The code is printed on
the package of each box of test strips. Operator can follow the following steps to set the code:
Matched code card is packed in the box of test strip. Take it out and insert into the code card
slot on the analyzer when the machine is turned off. Press Button to open the analyzer, it will
automatically read the code card and display the “CODE” indicator as well as code on the screen,
as showed in the figure below.

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Figure 13 Insert the Code Card Figure 14. Display Information of No.159 Code Card
Note: Check the displayed number with the code number printed on the package of
test strips and make sure they are the same.
When the above settings are finished, take the code card out, press and hold button to
turn off the analyzer or the analyzer can automatically be power off when there have been no
operations for 5 minutes. The code will be saved automatically by the analyzer and will not be
missing even if the batteries are taken out.
3.6 Detection of Blood Lipid
Following the steps below:
3.6.1 Preparation
Prepare the analyzer, test strip, lancing device, lancet, and swab. Put them on the working
table next to the waste container.
3.6.2 Installation of Lancing Device and Lancet
For usage of lancing device and lancet, please read their instructions for use.
3.6.3 Blood Sampling
Wash the hands of the subject thoroughly using soap or any other detergents. Wipe the hands
until they are totally dry. (It’s more recommended to rub his/her hands in hot water since it can
improve the blood circulation, making it easier to blood sample from finger tip). Soak the swab in
ethanol for medical use and then disinfect the finger tip. Wait the finger tip to dry.
Note: Do not use iodine or iodine-containing disinfectant to disinfect.
3.6.4 Insertion of Test Strip
Open the aluminum foil package of test strip or the tank of test strip and grab one test strip
(Close the tank immediately after taking one test strip).
Press the button to start the analyzer. When the Test Strip Indicator is flashing, insert the
test strip into the analyzer. Wait until the Sampling Indicator is flashing, apply the blood sample
onto the test strip.

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Figure 15. Code is “159”
Figure 16. Indicator to insert the test strip
Figure 17. Indicator to apply the blood sample
Note: Before inserting the test strip, check the code displayed on the screen and make sure it
is the same as the code on the package of test strip which you have picked. If not, please stop
this detection and reset the code following steps listed in Section 3.5.
3.6.5 Detection
Collect blood from selected area using lancing device and lancet and make sure the operating
process is in accordance with their instructions for use. Collect 35～40uL blood and apply to the
center of test area on the test strip. Never let the blood sampling device press or touch the test area.
When enough volume of blood has been applied on the test strip, the Sampling Indicator will stop
flash and “---” will be displayed on the screen, meaning that the detection has been successfully
initiated and will be finished in 120 seconds.
Figure 18. Running Test
When the test is finished, the result of TC concentration will be firstly displayed on the
screen. Press M Button or S Button to look up results for other items, including HDL, TG,
TC/HDL and LDL.

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Figure 19. Press M or S Button to see more results
When “Lo” is displayed on the screen for one of the paraanalyzers, the measurement of this
paraanalyzer in the blood sample is lower than the lower limit of detection range for this analyzer.
On the other hand, when “Hi” is displayed on the screen for one of the paraanalyzers, the
measurement of this paraanalyzer in the blood sample is higher than the upper limit of detection
range for this analyzer.
Figure 20. “Hi” and “Lo”displayed on the screen for TC
When “---” is displayed on the screen for one of the paraanalyzers, the analyzer is unable to
calculate the result for this paraanalyzer, which is often seen for TC/HDL or LDL detection. This
is because that TC/HDL ratio or LDL has to be calculated from the measurements of other
paraanalyzers. If one or more of these paraanalyzers are beyond the detection range of this
analyzer, as displayed in “Hi” or “Lo”, it would be impossible to calculate TC/HDL or LDL, as
showed in the figure below.

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Figure 21. “---” for Invalid Value
After one detection is finished, you can simply pull out the test strip and insert a new
one for next detection. If this is the last detection, press and hold button to turn off the
analyzer or the analyzer can automatically be power off when there have been no operations
for 5 minutes.
3.6.6 Print
If a printer is connected to the analyzer, select the Result Screen. Press and hold M Button
to print the result.
Cautions!
Upon detection, do not touch or push the button or the machine body.
The blood sample may be diseased. Operator should avoid blood contamination
upon sampling or applying blood. Protective gloves are recommended to wear
during these operations.
The test is recommended to be run under 15℃to 35 ℃.
It is recommended to close the tank of test strip after picking up one of the strips,
in order to avoid contamination of humidity to unused test strips.
When the Sampling Indicator is not flashing, do not apply the blood sample.
The lancing device can only be used for one single person. The lancet is disposable.
Cross-infection may be introduced when a single lancing device or lancet is used in
2 or more people.
When you are applying the blood sample to the test strip, make sure the volume
applied for the first time is enough. Do not apply for the second time. If the blood
volume is insufficient, replace a new test strip and repeat the process.
After detection, both test strip and lancet is contaminated with the blood sample
which is possibly diseased, thus these item should all disposable as medical waste
following standard processes.
3.7 Data Communication
Connect data communication and printer connector on the analyzer to computer via USB
cable so that it’s possible to transfer test data from analyzer to computer.
Besides, the PFS-30 type Blood Lipid analyzer is also equipped with Bluetooth function,
making it possible to directly transfer the data of current test immediately to equipment which has
been connected with the analyzer through Bluetooth, including cellphones and tablets.
To accomplish data communication with analyzer, users are allowed to design relevant
software or APP using these two communication methods introduced above. If users want to know
more information about data communication protocols upon design phase, please consult the
manufacturer.
3.8 Management of Saving Data
The memory capacity of the analyzer is 300 test results. Thus when a new test result is

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generated after the memory capacity is full, the result record of earliest test will be automatically
deleted so that the new one can be saved. Beside, the sequence number of the new test result will
be named from 1 again after 300 have been reached.
3.8.1 Inquiry
When the analyzer is turned off, press M Button to initiate the analyzer for inquiry. The first
screen is the “Select Test Number” screen, in which both the record number, test date and time
will all be displayed. Press M or S button to scan the test result one by one. Press and hold M or S
button for quick review. If the analyzer hasn’t saved any test record, “---” will be displayed on the
screen as showed in the figure below.
Figure 22 Select Record Number Figure 23 No Record
Note: There is a one-to-one correspondence relationship between the record number
and test.
Upon “Select Record Number”, press M or S button to find the record number that you want
to check, and press button to move to “Review Test Result” screen. The value TC for that test
will be displayed at first. Press M or S button can display the value of TC, HDL, TG, TC/HDL and
LDL in turn. If you want to go back to “Select Record Number” page, just press Button.
Figure 24. Operation Procedure to Review Saved Data
Note: For inquiry of CHD result, please refer to Section 3.9, in which the CHD risk
evaluation function of the analyzer has to be turned on before the inquiry, otherwise the
query will have no result because the selected sample cannot be analyzed for CHD risk.

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In the page of “Review Test Result”, press and hold M button can print the result using
connected printer, as showed in Figure 25
Figure 25. The printer is printing the result.
When the above settings are finished, take the code card out, press and hold “ ” to turn off
the analyzer or the analyzer can automatically be power off when there have been no operations
for 5 minutes.
3.8.2 Delete
All saved data can be deleted by one simple move. However, any data that have been deleted
cannot be restored, so be cautious to take this action.
Operation procedures are listed below:
When the analyzer is power off, press and hold M Button, the analyzer will be initiated for
data deletion procedure. Both “CLE” and “MEM” symbols will be displayed.
Figure 26. Indicator to Delete All Data
Press and hold S Button and M Button at the same time, “CLE” will be flashing until the
screen displays “---”, meaning that all saved data has been deleted successfully at the same time.
Figure 27. Succeed to Delete All Data
When the above settings are finished, take the code card out, press and hold button to
turn off the analyzer or the analyzer can automatically be power off when there have been no

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operations for 5 minutes.
3.9 CHD Risk Evaluation
When the CHD risk evaluation function of the analyzer has been successfully initiated, CHD
symbol in setting page will be turned on. First, go to “Review Test Result” screen, press and hold
S Button can move to the screen of CHD risk evaluation, in which the test result of the number
which you have selected will be analyzed for risk of CHD.
Operation procedures are listed below:
There are two evaluation methods for CHD risk evaluation: FRA and PRO, which can be
selected by pressing M or S button. As showed in Figure 28, either FRA or PRO can be selected,
and you can move to the next step by pressing and holding S Button to confirm your selection.
Figure28. Selection of FRA or PRO
After selecting FRA, press and hold S Button to confirm your selection, and the analyzer will
automatically display the screen of “Gender Selection”, in which you can select the right gender
for the test subject. Press and hold S Button can determine the gender, age, smoking history,
systolic blood pressure and medical history for treatment of hypertension in turns. For each page,
press M or S button to select different numbers or answers. The detailed procedures are described
in Figure 29.
Infos:
1. . FRA (ie. Framingham CHD Risk Evaluation): is a common method used in
America, which is indicated for evaluation of risk for CHD in future 10 years for
male or female residents aged between 30 to 79 years old.
2. PRO (ie. Procam CHD Risk Evaluation): is a commonly used method in Europe,
which is indicated for evaluation of risk for CHD in future 10 years for male
residents aged between 35 to 75 years old.

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Figure 29. FRA Settings
After selecting PRO, press and hold S Button to confirm your selection, and the analyzer will
automatically display the screen of “Age Selection”, in which you can select the right gender for
the test subject. Press and hold S Button can determine the age, smoking history, history of
diabetes mellitus, history of myocardial infarction and systolic blood pressure in turns. For each
page, press M or S button to select different numbers or answers. The detailed procedures are
described in Figure 30.

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Figure 30. PRO Settings
When all paraanalyzers have been determined, the CHD risk for this test subject will be
evaluated and displayed as Figure 31.
Figure31. Display of CHD Risk
Note: It’s allowed to press button at anytime during this evaluation procedure to go
back to “Data Inquiry” screen or press and hold button at anytime to turn off this
analyzer.