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.