WP21B WP21E Operation Manual PDF

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Operation Manual

Semi-auto Chemistry Analyzer


Model: WP21B/WP21E
For In Vitro Diagnostic Use
About this Manual
Version No.: A/4

Release Date: April 25, 2016

© 2004-2016 Genrui Biotech Inc. All rights reserved.

Item No.: P01.91.300077-04

11000010 (WP21B) / 11000013 (WP21E)

Statement
This manual will help you understand the operation and maintenance
of the product better. It is reminded that the product shall be used
strictly complying with this manual. User’s operation failing to comply
with this manual may result in malfunction or accident for which Genrui
Biotech Inc. (hereinafter called Genrui) cannot be held liable.

Genrui owns the copyrights of this manual. Without prior written


consent of Genrui, any materials contained in this manual shall not be
photocopied, reproduced or translated into other languages.

Materials protected by the copyright law, including but not limited to


confidential information such as technical information and patent
information are contained in this manual, the user shall not disclose
such information to any irrelevant third party.

The user shall understand that nothing in this manual grants him,
expressly or implicitly, any right or license to use any of the intellectual
properties of Genrui.

Genrui reserves the right to modify and update this manual without

I
prior notice.

Genrui reserves the final explanation right to this manual.

Warning
This system can only be operated by test professionals, doctors, lab
workers or personnel for system maintenance and troubleshooting,
who have been trained by Genrui.

It is important for the hospital or organization that employs this


equipment to carry out a reasonable maintenance schedule. Neglect of
this may result in machine breakdown or injury of human health.

Make sure to use the instrument under the provisions of this Operation
Manual. Otherwise, the instrument may not work normally, the test
result is unreliable and it may damage the instrument parts and
endanger people’s safety.

Customer Service Department

Manufacturer: Genrui Biotech Inc.


6F, Shanshui Building B, Nanshan Yungu Innovation
Address: Industrial Park, 1183 Liuxian Blvd, Nanshan District,
518055, Shenzhen, P.R. China
Website: www.genrui-bio.com
E-mail
[email protected]
Address:
Tel: +86 755 26835560
Fax: +86 755 26678789

II
Table of Contents
Chapter 1 Brief Introduction .............................................................. 1

1.1 Product overview ................................................................... 1


1.1.1 Brief introduction of this instrument ............................... 1
1.1.2 Basic performance and parameters ............................... 1
1.1.3 Product structure and composition ................................ 3
1.1.4 Scope of application....................................................... 3

1.2 Operation manual summary .................................................. 3

1.3 Symbols, screen printing, labels and figures ......................... 3


1.3.1 Symbols ......................................................................... 3
1.3.2 Screen printing and labels ............................................. 4
1.3.3 Figures ........................................................................... 5

1.4 Warranty and service ............................................................. 5

1.5 Training .................................................................................. 6

Chapter 2 Safety and Precautions .................................................... 7

2.1 Safety..................................................................................... 7

2.2 Precautions ............................................................................ 8

Chapter 3 Installation ....................................................................... 11

3.1 Instrument models ............................................................... 11

3.2 Installation operators ........................................................... 11

3.3 Damage check ..................................................................... 11

III
3.4 Packing list .......................................................................... 12

3.5 Installation requirements ..................................................... 12

3.6 Instrument Installation ......................................................... 13

Chapter 4 Structure .......................................................................... 15

4.1 Front view of the instrument ................................................ 15

4.2 Diagram of operation panel ................................................. 15

4.3 Back view of the instrument ................................................ 16

4.4 Menu interface ..................................................................... 16

Chapter 5 Routine Operations ......................................................... 18

5.1 Measurement flowchart ....................................................... 18

5.2 Routine operations and precautions .................................... 19

5.3 Sample measurement ......................................................... 20


5.3.1 Aspirating the cleaning solution ................................... 23
5.3.2 Aspirating distilled water .............................................. 24
5.3.3 Aspirating blank solution .............................................. 25
5.3.4 Aspirating standard solution......................................... 26
5.3.5 Aspirating sample solution ........................................... 27
5.3.6 Standby status ............................................................. 29
5.3.7 Setup ............................................................................ 30
5.3.8 Search .......................................................................... 32

5.4 Testing examples ................................................................. 32

Chapter 6 Software Operation ......................................................... 35

IV
6.1 QC review ............................................................................ 35

6.2 Result review ....................................................................... 37


6.2.1 To edit samples ............................................................ 37
6.2.2 To add results ............................................................... 39
6.2.3 To search results .......................................................... 41

6.3 Editing test items (Program) ................................................ 43


6.3.1 To add an item and edit its parameters ........................ 43

6.4 System setup ....................................................................... 49


6.4.1 Printing setup ............................................................... 50
6.4.2 Time setup ................................................................... 51
6.4.3 COM setup ................................................................... 51
6.4.4 Contrast setup .............................................................. 52
6.4.5 Cuvette setup ............................................................... 53

6.5 System maintenance ........................................................... 54


6.5.1 Temperature adjustment .............................................. 54
6.5.2 Aspiration volume setting ............................................. 55
6.5.3 Aspiration adjustment .................................................. 56
6.5.4 Absorbance testing ...................................................... 56
6.5.5 ADC adjustment ........................................................... 58
6.5.6 Restoration setting ....................................................... 59
6.5.7 Powerful cleaning......................................................... 60

Chapter 7 Daily Use and Maintenance............................................ 62

7.1 Daily maintenance and care ................................................ 62

7.2 Explanation about elimination or reduction of instrument


downtime ......................................................................................... 63

V
7.3 Preventive maintenance and inspection for safety purpose 64

7.4 List of replaceable components ........................................... 64

7.5 Common faults and troubleshooting .................................... 65

Chapter 8 Transportation and Storage ........................................... 68

8.1 Transportation ...................................................................... 68

8.2 Storage ................................................................................ 68

8.3 Graphic explanations on the outer package ........................ 68

Chapter 9 Commonly-used Consumables and Ordering


Information ........................................................................................ 70

Appendix ........................................................................................... 72

Appendix 1 Replace printing paper ................................................. 72

Appendix 2 Replace pump tubes .................................................... 73

Appendix 3 Clean the cuvette ......................................................... 74

Appendix 4 COM communication ................................................... 75

Appendix 5 List of test items and test combinations ....................... 77

Appendix 6 Hazardous substances ................................................ 80

VI
WP21 Series Operation Manual Chapter 1 Brief Introduction

Chapter 1 Brief Introduction


1.1 Product overview
1.1.1 Brief introduction of this instrument

Product name: Semi-auto Chemistry Analyzer

Safety classification: Electric-Shock Safeguard Level I, Overvoltage


Category II, Pollution Degree II

Regulatory classification: A kind of biochemical analysis system in the


category of analyzing instruments for clinical tests (6840), Regulatory
Class II

Operation mode: Continuous running

1.1.2 Basic performance and parameters

Basic performance

Deviation of
Within ± 3nm
filter accuracy

Filter half-width ≤ 12nm

Stray light Absorbance ≥ 2.5

For absorbance values in the range of


0.2~0.5, linear error is within ±5%.
Absorbance For absorbance values in the range of
linearity 0.5~1.0, linear error is within ±4%.
For absorbance values in the range of
1.0~1.8, linear error is within ±2%.

1
WP21 Series Operation Manual Chapter 1 Brief Introduction

Absorbance At 340nm, the absorbance change in 20


stability minutes should not be greater than 0.005.

It is expressed with coefficient of variation


Absorbance
(CV) and the value should not be greater
repeatability
than 1.0%

Temperature Temperature deviation ≤ ±0.3℃,


accuracy and
fluctuation ≤ ±0.2℃
fluctuation

Sample
≤ 1%
carryover rate

Intra-batch
clinical
ALT ≤ 5%, TP ≤ 2.5%, UREA ≤ 3.5%
precision
(CV%)

Basic parameters

Wavelength selector Filtering

Type of absorption cells Flow cells

End-point, two-point, kinetic


Analysis methods
methods, etc.

340, 380, 405, 505, 546, 578, 620


Wavelength
and 700nm (optional)

Power ≤ 180VA

Net weight About 6kg

2
WP21 Series Operation Manual Chapter 1 Brief Introduction

1.1.3 Product structure and composition

This instrument consists of a microprocessor, a main board, a


power-supply system, a sampling system, a colorimetric system, a
monitor and a printer.

1.1.4 Scope of application

This instrument is applicable to quantitative analysis of clinical


biochemistry items in medical institutions.

1.2 Operation manual summary


This operation manual mainly intends to help users learn about the
safety, installation, structure, analysis principle, operating procedures,
maintenance and service, problems and troubleshooting, etc. of the
semi-auto chemistry analyzer. Please follow this manual to operate the
instrument.

Note:

This manual may be revised appropriately without prior


notice.

1.3 Symbols, screen printing, labels and figures


1.3.1 Symbols

The following symbols listed in the table below are applicable to this
manual.

Symbol Meaning

Biohazard!
The background color of this symbol is yellow, the
symbol itself and the outline is black.

3
WP21 Series Operation Manual Chapter 1 Brief Introduction

Symbol Meaning

May cause electric shock

High temperature, which may lead to personal injury

Strong light, which may lead to eye injury

1.3.2 Screen printing and labels

The following screen printing and labels listed in the table below are
applicable to this manual.

Label Meaning

Serial number of the product

Equipotential terminal, connected with the ground cable

Production date

In vitro diagnostic devices, only for in vitro auxiliary


diagnosis

~ Alternating current

Power ON

4
WP21 Series Operation Manual Chapter 1 Brief Introduction

Label Meaning

Power OFF

POWER Main power supply

WASTE Outlet of waste liquid

COM Communication port, which can connect with the software


RS232 system in the testing department
1.3.3 Figures

Figures in this manual are only for illustration or examples, not for other
purposes. Subject to the real object while in operation, modification
may be made without prior notice.

1.4 Warranty and service


Genrui warrants that this product will be free from defects in materials
and workmanship that occur within the warranty period. This warranty
shall not apply to damages caused by the following situations:

1) Operation environment does not meet the specified requirements;

2) Not use the specified power supply or power supply is abnormal;

3) Man-made damage;

4) Non Genrui authorized personnel making the repair;

5) Other irresistible natural factors, such as earthquakes, fires, war,


etc.

6) Damage caused by accidents.

7) Replacement or removal of serial number label and manufacture


label.

If a product covered by this warranty is determined to be defective

5
WP21 Series Operation Manual Chapter 1 Brief Introduction

because of defective materials, components, or workmanship, and the


warranty claim is made within the warranty period, Genrui will, at its
discretion, repair or replace the defective part(s) free of charge. Genrui
will not provide a substitute product for use when the defective product
is being repaired.

1.5 Training
In order to help users properly use the analyzer and give full play to its
performance, Genrui holds periodical free training for users throughout
the world, please visit Genrui website or contact the local offices to get
the training schedule.

Only personnel trained by Genrui or its authorized distributors can


operate this instrument, otherwise it may damage the protection
provided by the instrument.

Please carefully read this manual and the related reagents instructions,
if not operating in accordance with the provisions of this instrument
manual, it may damage the provided protection or greatly affect the
test results.

6
WP21 Series Operation Manual Chapter 2 Safety and Precautions

Chapter 2 Safety and Precautions

The following are the warning symbols related to the analyzer, if ignore
these symbols, the users may run the risk of death or serious injury.
The following warning symbols are not sorted by their importance. All
the symbols have the equivalent importance.

2.1 Safety
Electric Shock

1) When the power supply is turned on, any person except


authorized service technicians is prohibited to open the
analyzer panel.

2) Avoid spilling any liquid onto the instrument tabletop. If


some liquid splashes into the analyzer, please cut off the
power supply immediately and contact Genrui promptly.

High Temperature

1) Before exchanging the bulb, please cut off the electricity


and wait at least 30 minutes until the bulb cools down.

2) You may be scalded if touching the print head and the


metal part around it.

Strong Light

Do not stare at the beams from the bulb. Otherwise your


eyes may be injured.

7
WP21 Series Operation Manual Chapter 2 Safety and Precautions

Biohazard

1) All the test samples, quality controls and standards


should be regarded as infectious. Please wear gloves when
contacting them.

2) All the wastes should be regarded as infectious and thus


you should wear gloves when contacting them. The
components touched with a test sample, such as pipetting
tips, cuvettes and measuring cups should be regarded as
infectious; so, you should wear gloves when contacting
them.

3) All the wastes are potentially infectious and should be


regarded as medical wastes and disposed according to the
current regulatory requirements.

4) When the service life of the instrument ends, it should be


disposed of as per local requirements for environmental
protection, and it cannot be disposed of and discarded as
common wastes.

2.2 Precautions
Scope of Application

This instrument is applicable to quantitative analysis of


clinical biochemistry items in medical institutions.

Operators

The analyzer can only be used by personnel who have


been trained and authorized by Genrui or its
representatives.

Actions in Case of Breakdown

If the instrument has a hazardous breakdown, such as fire,


strange smell, smoke or other dangerous situations, anyone
should directly cut off its electricity or the main power

8
WP21 Series Operation Manual Chapter 2 Safety and Precautions

supply, and then contact Genrui.

Application Environment

1) Please correctly install the instrument as per the


environmental conditions specified in this manual.
Otherwise, the test results obtained may be inaccurate and
the analyzer may be damaged.

2) If it is necessary to change its working environment,


please contact Genrui or its distributor in your region.

Electromagnetic Interference

1) The analyzer is susceptible to electromagnetic


interference during running, which may influence the test
results and lead to wrong operations. During its running,
please do not use devices generating electromagnetic
waves, such as electric drill, mobile phone and intercom.

2) The analyzer can emit electromagnetic waves during


running. Please do not install and use
electromagnetic-sensitive equipment near the analyzer.

Liquid Leakage

1) Check all the pipe connections before testing to verify if


there is leakage. Liquid leakage can make the aspiration
and dispensing volumes inaccurate.

2) Do not place reagents and samples on the analyzer


tabletop, to avoid liquid spillage and leakage.

Water Quality

The water quality should meet the following requirements.


Otherwise, the valves and pumps may be easily damaged
or cannot be cleaned:

9
WP21 Series Operation Manual Chapter 2 Safety and Precautions

 Particle diameter < 200μm

 Resistivity > 0.5MΩ/cm

 Colony count < 10cfu/ml

 Dissolved silicon < 0.1mg/L

Poor Grounding

1) The power supply must be correctly grounded.


Otherwise, there is the risk of electric shock.

2) The grounding impedance must be lower than 0.1Ω. Poor


grounding can cause unstable test results and housing
leakage, and thus there is the risk of electric shock.

Device Connection

1) For a device not permanently connected, please do not


place it at a location that is hard to disconnect.

2) For all the external switches or breakers and external


over-current protection systems, it is recommended to place
them near the analyzer.

3) The devices connecting with the COM RS232 port of this


analyzer should satisfy the requirements in the National
Standard GB 4793 of China.

Analysis Parameters

Incorrect analysis parameters may lead to false results. For


more information, please consult Genrui or the reagent
supplier.

10
WP21 Series Operation Manual Chapter 3 Installation

Chapter 3 Installation
3.1 Instrument models

This WP series can be divided into the following models:

WP21B: Involving seven wavelengths, i.e. 340, 380, 405, 505, 546,
578 and 620nm; a type of semi-auto chemistry analyzer with touch
screen

WP21E: Involving six wavelengths, i.e. 340, 405, 505, 546, 578 and
620nm; a type of semi-auto chemistry analyzer without touch screen

3.2 Installation operators


This analyzer can only be installed by Genrui personnel or its
authorized distributors, and the user should provide the required
environment and space. When you receive the analyzer, please notify
Genrui or the local distributor immediately.

3.3 Damage check


All the analyzer packages have been strictly examined by Genrui
personnel before shipment. When you receive the instrument, please
carefully check to verify whether there are the following damages
before opening the packaging box:

1) Inversion or deformity of the outer package.

2) Obvious moistened marks on the outer package.

3) Obvious crash marks on the outer package.

4) Indication of the outer package been opened.

Once you find any of the above issues, please do not open the
package and do not power on the instrument. Otherwise, it may lead to
electric shock. Please notify the local distributor immediately.

11
WP21 Series Operation Manual Chapter 3 Installation

If the outer package is intact, please open the packaging box and
check the items in the box at the presence of the distributor or Genrui
personnel:

1) Verify if all the components are equipped according to the packing


list.

2) Carefully check the appearance of all the components to verify


whether there is breakage, crash or deformity.

3.4 Packing list


Please check the Packing List in the instrument packaging box.

3.5 Installation requirements


Content Requirements

Flat tabletop with a tilt of < 1/200 and sufficient


intensity, which can bear the weight of 50kg;
Dust-free, without corrosive and inflammable
Location gases, free from heat or wind sources and
mechanical vibration;
Avoidance of direct sunlight and with good
ventilation
Enough space to place the analyzer with the area
Space 2
of at least 1m

Temperature 10℃-30℃

Humidity Relative humidity ≤ 70%

Atmospheric
70.0kPa-106.0kPa
pressure

Able to exchange air with the external environment,


Ventilation
smooth air flow, not directly blowing into the

12
WP21 Series Operation Manual Chapter 3 Installation

analyzer

100-240V~, 50/60Hz, correctly grounded and the


Power supply
grounding impedance is less than 0.1Ω.

Electromagnetic Do not close to an electric-brush engine or electric


waves devices which are frequently switched on/off.

3.6 Instrument Installation


1) Open the special packaging box of this analyzer and carefully
verify if the instrument and accessories in the box are consistent with
the packing list. If there is any loss or damage, please contact the
supplier at once.

2) If the articles in the box are correct, take out the instrument
carefully and put it on the stable and flat workbench.

3) Ground the grounding rod at the rear panel of this analyzer via an
earth wire specially designed for medical instruments (grounding
impedance < 0.1Ω).

4) Take out the power cable, plug one end into the power jack at the
rear panel and insert the other end into the grounded three-wire
socket.

5) The fuse used for this instrument is indicated as ―F3AL250V‖,


which is a type of glass-tube rapid-fusing device with double-cap
lead wires and has 3A of the rating current and 250V of the rating
voltage.

6) If the analyzer should be connected with the Laboratory


Information System (LIS) or Hospital Information System (HIS), take
out the serial port cable and connect one end to COM RS232 at the
instrument rear and the other end to the computer. The serial port is
set according to the instructions of LIS or HIS

7) For a device not permanently connected, please do not place it


at a location that is hard to disconnect.

13
WP21 Series Operation Manual Chapter 3 Installation

8) If different devices need to cooperate together, to achieve some


functions, a same reference potential is required, then it is necessary
to connect all the isoelectric terminals. Isoelectric connection can
inhibit potential difference, thereby eliminating electromagnetic
interference. If it is necessary to make an isoelectric connection, take
out the attached isoelectric grounding cable and insert it into the
isoelectric port.

14
WP21 Series Operation Manual Chapter 4 Structure

Chapter 4 Structure
4.1 Front view of the instrument
Built-in thermal Display screen
printer

Sliding door at
the housing cover

Cuvettes
Keyboard

Figure 1

4.2 Diagram of operation panel


Power
indicator
Number key
Confirm key,
Punctuation key used to confirm
an operation
Used to return to
Paper-feed key
the previous menu
Delete key Switchover key, used to Cursor key
switch among
uppercase or lowercase
lettles and numbers

Figure 2

15
WP21 Series Operation Manual Chapter 4 Structure

4.3 Back view of the instrument

RS-232 serial port Housing fan Waste liquid pipe

Power switch Power jack Isoelectric Peristaltic pump


grounding rod

Figure 3

4.4 Menu interface


Note: For the operations mentioned below, if you use an instrument
with a touch screen, you can click an appropriate icon or press the
corresponding number key to perform the specific operation; but if you
use an instrument without touch screen, you can only use the
appropriate number keys.

16
WP21 Series Operation Manual Chapter 4 Structure

As illustrated in the figure above, the main interface displayed after


instrument startup has six submenus, which can be selected with the
number keys by operators.

During routine work, operators mainly use Items 1 and 3; Item 1 can
conduct the sample testing and Item 3 can help you view or print a
report.

17
WP21 Series Operation Manual Chapter 5 Routine Operation

Chapter 5 Routine Operations


5.1 Measurement flowchart

18
WP21 Series Operation Manual Chapter 5 Routine Operation

5.2 Routine operations and precautions


Routine operations:

1) Startup: Turn on the power supply and enter the main interface
after the system self-checking. Preheat the analyzer for more
than 15 minutes.

2) To measure samples: Prepare the samples and reagents


according to the reagent instruction. After reacting for the time
period required by the reagent instruction, press the number key
―1‖ on the main menu interface to open the ―Measure Samples‖
window, and then measure the samples as per the wizard.

3) To print reports: After measurement, return to the main menu and


directly press ―3‖ to open the ―Result‖ window, then press ―3‖
again and input an appropriate No. to print the desired report.

4) To edit samples: Press ―3‖ to open the ―Result Review‖ window,


and then press ―1‖ to edit the patient’s information.

5) To wash pipes: After testing, please use the cleaning solution to


wash the pipes.

6) Shutdown: After completion of all the operation procedures,


please turn off the electricity.

Precautions:

1) This analyzer should keep away from moisture and sunlight and
also should be maintained periodically.

2) This instrument can only be used by trained medical


professionals.

3) Wash the flow cell to make them clean.

4) In regions with a cold climate, after using at a low temperature in


winter, drain the liquid in the flow cell before shutdown. Otherwise,
the liquid in the flow cell may freeze, thus damaging the cell.

19
WP21 Series Operation Manual Chapter 5 Routine Operation

5) Calibration should be performed during analysis to ensure the


result accuracy.

6) The wastes generated should be regarded as medical wastes for


disposal.

5.3 Sample measurement


Press the number key ―1‖ on the main menu to open the ―Item Choice‖
window, as illustrated in Figure 5-1:

Figure 5-1

Enter the desired item number (e.g. ―1 ALT‖) to enter the measurement
interface of this item, as illustrated in Figure 5-2:

Figure 5-2

20
WP21 Series Operation Manual Chapter 5 Routine Operation

After the light-source lamp becomes stable, the system will open the
measurement interface, or you can press ―Skip‖ to skip the preheating
step and enter the measurement interface, as illustrated in Figure 5-3:

Figure 5-3

First, by pressing the number key ―1‖, the system will automatically
switch to the corresponding filter and test the original value of the
measurement channel without illumination (dark-current value), as
illustrated in Figure 5-4:

Figure 5-4

21
WP21 Series Operation Manual Chapter 5 Routine Operation

If the filter wheel switch succeeded, the screen is displayed as shown


in Figure 5-5:

Figure 5-5

If the filter wheel switch failed, the screen is displayed as shown in


Figure 5-6:

Figure 5-6

22
WP21 Series Operation Manual Chapter 5 Routine Operation

5.3.1 Aspirating the cleaning solution

After testing the dark current, the system will automatically enter the
―Aspirate Cleaning Solution‖ interface, as illustrated in Figure 5-7:

Figure 5-7

Operators can perform the following operations

a) Place the cleaning solution (distilled water or sodium


hypochlorite) onto the analyzer and press the number key ―1‖ to
confirm. Then, the instrument will begin to aspirate the cleaning
solution.

b) If washing once is not enough, press the number key ―2‖ to


return to the previous step for washing again.

c) If it is not necessary to wash, press the number key ―3‖ to skip


the ―Aspirate Cleaning Solution‖ procedure and directly enter into the
next step.

d) Press ―Exit‖ to return to the main menu.

23
WP21 Series Operation Manual Chapter 5 Routine Operation

5.3.2 Aspirating distilled water

After aspirating the cleaning solution, the system will automatically


enter the ―Aspirate Distilled Water‖ interface, as illustrated in Figure
5-8:

Figure 5-8

Operators can perform the following operations:

Place distilled water onto the analyzer and press the number key ―1‖ to
confirm. Then, the instrument will begin to aspirate distilled water and
measure its ADC value, the screen is displayed as Figure 5-9:

Figure 5-9

24
WP21 Series Operation Manual Chapter 5 Routine Operation

Every time after the filter wheel rotates, the system will prompt you to
aspirate distilled water for calibration of absorbance zero-value. If the
difference between the original value and zero value of distilled water
is less than 1000, the system will display ―Abnormal Light Path‖. At this
time, please check the light path. If the difference between the original
value and zero value of distilled water is more than 1000 but less than
30,000, the system will display ―Abnormal ADC‖. At this time, please
check the ADC amplification factor and whether there are air bubbles
in the liquid lines.

5.3.3 Aspirating blank solution

When a test item is measured at the first time and its blank test has
been defined, the system will automatically enter the blank test
interface after completion of absorbance testing, and the words ―ASP
Blank‖ continuously flashes. The screen is displayed as Figure 5-10:

Figure 5-10

After placing the blank solution onto the analyzer, press the number
key ―1‖, the instrument will begin to aspirate the blank solution. After
the test, the absorbance value of the blank solution will display on the
screen and prompts you to remove the blank solution. The screen is
displayed as Figure 5-11:

25
WP21 Series Operation Manual Chapter 5 Routine Operation

Figure 5-11

5.3.4 Aspirating standard solution

When the system enters the ―Aspirate Standard Solution‖ interface, if


there is only one calibrator value, the screen is displayed as Figure
5-12:

Figure 5-12

After placing the standard solution onto the analyzer, press the number
key ―1‖, the instrument will begin to aspirate the standard solution. After
the test, the absorbance value of the standard solution will display on
the screen and prompts you to remove the standard solution. The
screen is displayed as Figure 5-13:

26
WP21 Series Operation Manual Chapter 5 Routine Operation

Figure 5-13

5.3.5 Aspirating sample solution

If the analyzer has tested the blank and standard solutions for this item,
then after measurement of the sample solution, the system will directly
enter into the testing interface for next sample, as illustrated in Figure
5-14. If this item is tested for the first time and its blank and standard
have been defined, then the blank and standard testing should be
performed before sample measurement.

Figure 5-14

27
WP21 Series Operation Manual Chapter 5 Routine Operation

After placing the sample solution onto the analyzer, press the number
key ―1‖, the instrument will begin to aspirate the sample solution. After
the test, the absorbance value of the sample solution will display on the
screen and prompts you to remove the sample solution. The test
results are displayed as shown in Figure 5-15, meanwhile, the system
will automatically measure the next patient sample under the same test
item. If you want to reduce the cross-contamination between samples,
place distilled water onto the analyzer, press the number key ―0‖, the
instrument begin to aspirate the distilled water, immediately remove it
after hearing the ―di-di‖ sound, the instrument will clean the liquid path
and drain the distilled water within the cuvette.

Figure 5-15

If the item is tested by the kinetic method, the screen will dynamically
display the reaction curve during measurement of the standard and
sample, as illustrated in Figure 5-16:

28
WP21 Series Operation Manual Chapter 5 Routine Operation

Figure 5-16

The results are displayed in the same way as other measurement


methods.

5.3.6 Standby status

If there are no operations within 30 minutes, the instrument will be in


standby status and the light-source lamp will turn off. The screen is
displayed as shown in Figure 5-17. Ten minutes later, the monitor
backlight will shut down.

Figure 5-17

Press any key on the standby interface to return to the last interface
before standby.

29
WP21 Series Operation Manual Chapter 5 Routine Operation

5.3.7 Setup

In the ―Measure‖ menu, choose an item, after heating, you can set this
parameter. Press ―Set‖ or the number key ―2‖ on the keypad, the
screen is displayed as Figure 5-18:

Figure 5-18

In this interface, you can set the printing, edit a test item, sample or QC
and switch between different modes.

5.3.7.1 Printing setup

See details in 6.4.1.

5.3.7.2 Item editing

See details in 6.3.1.2.

5.3.7.3 Sample editing

See details in 6.2.1.

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WP21 Series Operation Manual Chapter 5 Routine Operation

5.3.7.4 QC editing

Press the number key ―4‖ on the ―Set‖ interface to display a screen like
Figure 5-19:

Figure 5-19

In the ―Edit QC‖ interface, you can perform the following operations:

a) Item

Operation: The test item has been selected when entering the
measurement, so it cannot be changed in this ―Edit QC‖ interface.

b) LN

Operation: Press the number key ―1‖ to set the LN. The LN
number can be freely revised in the range of 1~99999999999999,
but repetition is not allowable. If you do not change it, the default
value is 0, which means no increase will occur.

c) Target value

Operation: Press the number key ―1‖ to set the value.

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WP21 Series Operation Manual Chapter 5 Routine Operation

5.3.7.5 Mode switching

Press the number key ―5‖ and display a screen like Figure 5-20:

Figure 5-20

Normal: The mode for measurement of patient samples.

QC: The mode for measurement of QC.

Exit: Press ―Exit‖ key to return to the measurement interface.

5.3.8 Search

Press the number key ―3‖ to search the ―QC Review‖ or ―Result
Review‖ menu. See details in 6.1 or 6.2.3.

5.4 Testing examples


I. GPT/ALT determination by kinetic method

1) Set the following parameters of this item in the ―Program‖ menu


according to the reagent instruction:

Name: GPT/ALT Method: Kinetic method


Number of wavelengths: 1 Temperature: 37℃
Sample volume: 500μL Decimal places: 0
Unit: μ/L Blank: No Wavelength 1: 340
Sampling points: 2 Normal value (high): 40
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WP21 Series Operation Manual Chapter 5 Routine Operation

Normal value (low): 0 Correction: 1.000, 0.00


Calibration: No Linear range: <500
Delay time: 30S Interval time: 40S Factor: 1746.0

2) Press the number key ―1‖ on the ―Item Choice‖ window to choose
the ―ALT‖ item. Then, the system begins to preheat and will enter the
measurement interface after the temperature is stable. Enter the
number key ―1‖ to select ―Measure‖. When the system is ready, the
screen will display ―ASP Rinse‖. Place the cleaning solution onto the
analyzer and press ―1 Sample‖ to start the washing operation. After
completion, the screen displays ―ASP DI Water‖. Place the distilled
water onto the instrument and press ―1 Sample‖ to measure the
absorbance.

3) The screen displays ―ASP Sample‖. Place the numbered patient


samples onto the instrument in order and press ―1‖ to start
measurement of sample.

4) After aspirating the sample solution, the analyzer will display the
reaction curve on its screen during testing, as illustrated in Figure 5-21:

Figure 5-21

II. Determination of total protein by end-point method

1) Set the following parameters of this item in the ―Program‖ menu


according to the reagent instruction:

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WP21 Series Operation Manual Chapter 5 Routine Operation

Name: TP Method: End-point method


Number of wavelengths: 1 Temperature: 37℃
Sample volume: 800μL Decimal places: 1
Unit: μ/L Blank: Reagent
Wavelength 1: 546 Sampling points: 1
Normal value (high): 82.0 Normal value (low): 62.0
Correction: 1.000, 0.00 Calibration: No
Linear range: <100.0 Delay time: 3S
Standard: 70.0

2) Press the number key ―5‖ on the ―Item Choice‖ window to choose
the ―TP‖ item. Then, the system begins to preheat and will enter the
measurement interface after the temperature is stable. Enter the
number key ―1‖ to select ―Measure‖. When the system is ready, the
screen will display ―ASP Rinse‖. Place the cleaning solution onto the
analyzer and press the key ―1‖ to start the washing operation.

3) After completion, the screen displays ―ASP DI Water‖. Place distilled


water onto the instrument and press ―1‖ to measure the absorbance.
After testing, the screening display ―ASP Blank Solution‖. Place the
blank solution onto the analyzer and press ―1‖ to confirm the operation.

4) At this time, the screen displays ―ASP Standard Solution‖ (if the
screen displays ―ASP Sample‖, please press the number key ―2‖ to
open the ―ASP Standard Solution‖ window). Place the standard
solution onto the instrument and press ―1‖ to perform measurement.
Calculate the factor after the testing is completed.

5) After measurement of the standard solution, the screen displays


―ASP Sample‖. Place the numbered patient samples onto the
instrument in order and press ―Sample‖ to start measurement of
sample solutions.

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WP21 Series Operation Manual Chapter 6 Software Operation

Chapter 6 Software Operation


6.1 QC review
Quality controls are used to examine and control the instrument
precision during assay, monitor the changes of stability, improve the
result consistency for inter- and intra-batch samples during routine
assay, and thus finally ensure the reliability of test results for every
patient sample.

To complete a QC, a kind of QC material should be measured in the


―Measure Samples‖ interface. After obtaining more than five groups of
results for a single QC number under the same test item, a QC
statistical report for this QC number under the test item can be made.

Press the number key ―2‖ on the main menu and display a screen like
Figure 6-1:

Figure 6-1

a) To input a QC number

Set a QC number by searching with left and right cursor keys or


pressing the number key ―1‖.

b) To search results

Press the number key ―2‖ to view the QC results. The screen is

35
WP21 Series Operation Manual Chapter 6 Software Operation

displayed as Figure 6-2:

Figure 6-2

Press to browse the results.

Press the number key ―1‖ to print the results.

Press the number key ―2‖ to delete currently displayed results.

Press ―Exit‖ to return to the previous interface.

c) Statistics

Press the number key ―3‖ on the ―QC Review‖ interface to display a
screen like Figure 6-3:

Figure 6-3

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WP21 Series Operation Manual Chapter 6 Software Operation

Press the number key ―1‖ to change the target value.

Press the number key ―2‖ to print the statistical results.

Press ―Exit‖ to return to the previous interface.

6.2 Result review


Press the number key ―3‖ on the main menu and display a screen like
Figure 6-4:

Figure 6-4

6.2.1 To edit samples

Press the number key ―1‖ on the ―Result‖ interface to display a screen
like Figure 6-5:

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WP21 Series Operation Manual Chapter 6 Software Operation

Figure 6-5

You can edit the information about patient samples on the sample
editing interface, and the specific operations are described as follows:

6.2.1.1 No.

If you need to measure another test item for the same patient, change
the current ―No.‖ to the original ―No.‖ of this patient.

6.2.1.2 ID

The ID number can be freely revised in the range of


1~99999999999999, but repetition is not allowable. If you do not
change it, the default value is 0, which means no increase will occur.

6.2.1.3 Sex

Operation: Use left and right cursor keys to choose

Options: -- (None), Male, Female, Child, Infant, Newborn

6.2.1.4 Age

Operation: Press the number key ―1‖ to set the value.

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WP21 Series Operation Manual Chapter 6 Software Operation

6.2.1.5 Blood group

Operation: Use left and right cursor keys to choose

Options: (None), A, B, AB, O, RH+, RH-

6.2.2 To add results

Some test items must be completed by other instruments, but the


results should be stored or printed with those obtained in this analyzer.
At this time, you can use this function. However, you must define the
item first.

Press the number key ―2‖ on the ―Result Review‖ interface to add
results. The screens are displayed as Figures 6-6.1 and 6-6.2:

Figure 6-6.1

Figure 6-6.2

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WP21 Series Operation Manual Chapter 6 Software Operation

1) No.

If you need to measure another test item for the same patient,
change the current ―No.‖ to the original ―No.‖ of this patient.

2) ID

The ID number can be freely revised in the range of


1~99999999999999, but repetition is not allowable. If you do not
change it, the default value is 0, which means no increase will
occur.

3) Sex

Operation: Use left and right cursor keys to choose

Options: -- (None), Male, Female, Child, Infant, Newborn

4) Age

Operation: Press ―Set‖ or the number key ―1‖ to set the value.

5) Blood group

Operation: Use left and right cursor keys to choose

Options: (None), A, B, AB, O, RH+, RH-

6) Item

Operation: Press ―Set‖ or the number key ―1‖ to set the item

7) Decimal digits

Operation: Use left and right cursor keys to choose

Options: 0, 1, 2, 3, 4, 5

8) Results

Operation: Press the number key ―1‖ to set the value.

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WP21 Series Operation Manual Chapter 6 Software Operation

9) Unit

Operation: Use left and right cursor keys to choose

Options: μ/L, μ/mL, μmol/L, mmol/L, g/L, mg/L, g/dL, g/mL, X10
12/dL, ABS

If you enter a patient number that does not exist, the system will
display ―This No. is not present‖. Then, the system will automatically
return to the ―Add Results‖ interface.

After adding, press ―Exit‖ key to save and exit.

6.2.3 To search results

Press ―3‖ on the ―Result‖ interface to display a screen like Figure 6-7:

Figure 6-7

1) Entering the ―No.‖

Operation: Press the number key ―3‖ to open the keyboard


interface. And then enter the ―No.‖ directly.

2) Entering the ID

Operation: Press the number key ―4‖ to open the keyboard


interface. And then enter the ―ID‖ directly.

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WP21 Series Operation Manual Chapter 6 Software Operation

3) Printing

Operation: Press the number key ―1‖ to print all the results of the
currently displayed ―No.‖.

4) Searching

Operation: Press the number key ―2‖ to view all the results of the
currently displayed sample number. The screen is displayed as
Figure 6-8:

Figure 6-8

Press the number key ―1‖ to print all the current results; press ―Up‖
or ―Down‖ to view the last or next result.

5) Printing the results of the day

Operation: Press the number key ―2‖ to print all the results of the
day's tests.

6) Exit

Return to the previous interface.

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WP21 Series Operation Manual Chapter 6 Software Operation

6.3 Editing test items (Program)


Press the number key ―4‖ on the main interface to display a screen as
shown in Figure 6-9:

Figure 6-9

6.3.1 To add an item and edit its parameters

6.3.1.1 To add an item

Press the up and down cursor keys to jump to the desired page.

Press the number key ―9‖ and display a screen like Figure 6-10:

Figure 6-10

You can set up the name of a new item and its parameters.

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WP21 Series Operation Manual Chapter 6 Software Operation

6.3.1.2 To set up the item parameters

In an interface as illustrated in Figure 6-9, press the number key of the


corresponding item to open the ―Program‖ window like Figure 6-11:

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WP21 Series Operation Manual Chapter 6 Software Operation

Figure 6-11

You can set up the following parameters in the ―Program‖ window:

1) Method

Operation: Use left and right cursor keys to choose

45
WP21 Series Operation Manual Chapter 6 Software Operation

Options: End-point [E], two-point, kinetics [K], cutoff [C],


division [D]

2) Wavelength

Operation: Use left and right cursor keys to choose

Options: 1 or 2

3) Temperature

Operation: Use left and right cursor keys to choose

Options: 37℃, 30℃, room temperature

4) Aspiration volume

Operation: Press the number key ―1‖ to set the value.

Setting range: 0 - 9999μL

5) Decimal digits

Operation: Use left and right cursor keys to choose

Options: 0, 1, 2, 3, 4,

6) Unit

Operation: Use left and right cursor keys to choose

Options: -- (None), μ/L, μ/mL, μmol/L, mmol/L, g/L, mg/L, g/dL,


12
g/mL, X10 /dL, ABS

7) Reagent blank

Operation: Use left and right cursor keys to choose

Options: Yes, No

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WP21 Series Operation Manual Chapter 6 Software Operation

8) Wavelength

Operation: Use left and right cursor keys to choose

Options: 340nm, 380nm, 405 nm, 505 nm, 546 nm, 578 nm,
620 nm

9) Sampling points

Operation: Use left and right cursor keys to choose

Note: The setting range of the kinetic [K] method is 3 – 9.

10) Normal values

Operation: After selecting this parameter, press the number


key ―1‖ to set the value.

11) Correction

Operation: After selecting this parameter, press the number


key ―1‖ to set the value.

12) Calibration

Operation: Use left and right cursor keys to choose

Options: Single-point linear, two-point linear, multiple-point


non-linear, not calibration

13) Linear range

Operation: Choose ―>‖ or ―<‖ using left and right cursor keys
and press the number key ―1‖ to set the value.

14) Delay time

Operation: Press the number key ―1‖ to set the value.

15) Interval time

Operation: Press the number key ―1‖ to set the value.

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WP21 Series Operation Manual Chapter 6 Software Operation

16) Standard values

Operation: Press the number key ―1‖ to set the value.

17) Attached explanation:

If the measurement method is set as ―division [D]‖, the screen


will be displayed as Figure 6-12 below:

Figure 6-12

Note: ―Y=A/B‖ is a formula, in which A and B represent two related


items that have been tested.

If the measurement method is set as ―cutoff [C]‖, the screen will be


displayed as Figure 6-13 below:

Figure 6-13

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WP21 Series Operation Manual Chapter 6 Software Operation

Note: ―Y=A+B+C-D-E-F‖ is a formula, in which A, B, C, D, E and F


represent two related items that have been tested.

18) After completion of editing or pressing ―Exit‖, display a screen like


Figure 6-14:

Figure 6-14

Press ―1‖ to save the changes.

Press ―2‖ to cancel the changes and return to the ―Program‖ interface.

Directly press ―Menu‖ to exit the ―Program‖ interface. At this time, the
changes you made will not be saved.

6.4 System setup


Press the number key ―5‖ on the main interface to enter the system
setup interface. The screen is displayed as Figure 6-15:

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WP21 Series Operation Manual Chapter 6 Software Operation

Figure 6-15

6.4.1 Printing setup

Press the number key ―1‖ on the ―Setup‖ interface to display a screen
like Figure 6-16:

Figure 6-16

Press ―1‖ to select or cancel this option. When the option is checked,
the instrument will automatically print the result report after measuring
a patient’s sample.

Press ―2‖ to select or cancel this option. When the option is checked, if
you use the kinetics method to measure samples, the instrument will
automatically print the reaction curve after measuring a patient’s
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WP21 Series Operation Manual Chapter 6 Software Operation

sample.

Press ―3‖ to select or cancel this option. When the option is checked,
absorbance values will be added into the result report after measuring
a patient’s sample.

6.4.2 Time setup

In the system setup interface, press ―2‖ to open the ―Set Time‖ window.
The screen is displayed as Figure 6-17:

Figure 6-17

Press the left and right direction keys or directly click the left and right
keys on the screen to select the date and time needing to be changed.
After entering the desired values, press ―Enter‖ to save the changes or
press ―Exit‖ to cancel the changes.

6.4.3 COM setup

In the system setup interface, press ―3‖ to open the ―COM‖ window.
The screen is displayed as Figure 6-18:

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WP21 Series Operation Manual Chapter 6 Software Operation

Figure 6-18

You can set the parameters for COM communication. Press left and
right keys to select the desired parameters.

You can select ―On‖ or ―Off‖ for COM status. If you select ―On‖, the
parameters will be displayed in the COM parameter-setup interface.

There are five options for baud rate, i.e. 9600, 19200, 38400, 57600
and 115200.

After determining the baud rate, you can select the check parameters;
for parity check, there are three options, including ―Odd‖, ―Even‖ and
―None‖.

6.4.4 Contrast setup

Due to fluctuation of environmental temperature, personal habits or


other external factors, the screen contrast may be not very satisfying.
You can adjust the contrast according to the following procedure.

In the system setup interface, press ―4‖ to open the ―Contrast‖ window.
The screen is displayed as Figure 6-19:

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WP21 Series Operation Manual Chapter 6 Software Operation

Figure 6-19

Adjust the backlight as needed by pressing the up, down, left and right
keys on the keyboard.

6.4.5 Cuvette setup

In the system setup interface, press ―5‖ to open the ―Cuvette‖ window.
The screen is displayed as Figure 6-20:

Figure 6-20

In this interface, you can switch between ―Flow Cell‖ and ―Cuvette‖, the
system default is ―Flow Cell‖. If you need to use cuvette to test samples,
press ―5‖ to switch to manual measurement mode.

Note: For manual testing, please prepare cuvettes by yourself, our

53
WP21 Series Operation Manual Chapter 6 Software Operation

company does not provide cuvettes.

6.5 System maintenance


Press the number key ―6‖ on the main interface to open the ―Maintain‖
window. The screen is displayed as Figure 6-21:

Figure 6-21

6.5.1 Temperature adjustment

In the ―Maintain‖ interface, press ―1‖ to open the ―TEMP ADJ‖ window.
The screen is displayed as Figure 6-22:

Figure 6-22

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WP21 Series Operation Manual Chapter 6 Software Operation

Press the up, down, left and right keys on the keyboard to set the
parameters.

―TEMP‖ is used to observe the real-time temperature changes of


colorimetric cells during running.

For ―Set TEMP‖, you have two options: 30℃ and 37℃.

―ADJ‖ is used to perform fine tuning for the working temperature of


colorimetric cells.

―Parameter‖ indicates the default base value.

A thermometer is required for comparative adjustment.

6.5.2 Aspiration volume setting

In the ―Maintain‖ interface, press ―2‖ to open the ―Set ASP‖ window.
The screen is displayed as Figure 6-23:

Figure 6-23

By using this function, you can arbitrarily set the ―Clean VOL‖ and
―Sample VOL‖ in the range of 0~9999μL. The set cleaning volume
must ensure that the pipelines are clean after washing. The default
value of ―Clean VOL‖ is 1200μL and that of ―Sample VOL‖ is 1000μL,
which can be adjusted according to the actual situation.

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WP21 Series Operation Manual Chapter 6 Software Operation

6.5.3 Aspiration adjustment

In the ―Maintain‖ interface, press ―3‖ to open the ―ASP ADJ‖ window.
The screen is displayed as Figure 6-24:

Figure 6-24

Enter the desired values in the fields of ―Set VOL‖ and ―Real VOL‖ and
get the aspiration volume determined in the ―Set VOL‖ field. Press
―Sample‖ to start aspiration and observe whether the aspirated volume
is accurate. If the sample after aspiration is exhausted, increase the
value in ―Real VOL‖; if the sample after aspiration remains a large
amount, decrease the value in ―Real VOL‖.

6.5.4 Absorbance testing

In the ―Maintain‖ interface, press ―4‖ to open the ―ABS‖ window. The
screen is displayed as Figure 6-25:

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WP21 Series Operation Manual Chapter 6 Software Operation

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WP21 Series Operation Manual Chapter 6 Software Operation

Figure 6-25

Please operate according to the prompts on the screen. Absorbance


testing is to allow the system to determine the absorbance changes in
different periods and correct accordingly, thereby making the results
more reliable.

6.5.5 ADC adjustment

In the ―Maintain‖ interface, press ―5‖ to open the ―ADC ADJ‖ window.
The screen is displayed as Figure 6-26:

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WP21 Series Operation Manual Chapter 6 Software Operation

Figure 6-26

Press or to set the parameters.

Press or to switch among the set parameters.

Place distilled water onto the instrument and click ―Sample‖ or press
―1‖ to start aspiration.

a) By using or , the wavelength can be set as 340, 380, 405,


505, 546, 578, or 620nm.

b) Generally, 50000~55000 of the ADC value is the most suitable. If


the ADC value for a wavelength is not within this range, the
parameter can be adjusted. Using or , the parameter can
be set in the range of 0~255.

c) Using and , the working status of light-source lamp can be


switched between ―On‖ and ―Off‖.

During ADC adjustment, the light-source lamp should be set to ―On‖.

6.5.6 Restoration setting

In the ―Maintain‖ interface, press ―6‖ to open the ―Restore‖ window. The
screen is displayed as Figure 6-27:

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WP21 Series Operation Manual Chapter 6 Software Operation

Figure 6-27

1) To delete results

Press ―1‖ to delete all the patient results stored in the instrument.

2) To delete QC

Press ―2‖ to delete all the QC results stored in the instrument.

3) To initialize items

Press ―3‖ to initialize the parameter settings of all the built-in items in
the instrument.

4) To initialize system settings

Press ―4‖ to initialize the built-in parameter settings in the instrument,


such as print settings, COM, contrast and aspiration volume.

6.5.7 Powerful cleaning

In the ―Maintain‖ interface, press ―7‖ to open the ―Soak‖ window. The
screen is displayed as Figure 6-28:

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WP21 Series Operation Manual Chapter 6 Software Operation

Figure 6-28

Place alcohol underneath the sampling position, press ―1‖ to aspirate


the alcohol and remove it after hearing ―di-di‖ sound, the screen is as
shown in Figure 6-29. Wait for the end of the countdown, the
instrument will automatically drain the alcohol, press ―Exit‖ to
immediately empty the cuvette and return to the system maintenance
screen.

Figure 6-29

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WP21 Series Operation Manual Chapter 7 Daily Use and Maintenance

Chapter 7 Daily Use and Maintenance

In order to maximize the analyzer’s performance, ensure its reliability


and extend its service life, please perform maintenance and service in
strict accordance with the requirements in this chapter.

7.1 Daily maintenance and care


1) Use method of keyboard

The instrument keyboard is a type of slight-touch product; a key has no


response when pressed and can only respond during releasing.
Therefore, operators should pay careful attention not to press the keys
strongly, thereby avoiding keyboard damage.

2) Daily maintenance

After sample measurement, immediately wash the lines with distilled


water several times, to minimize the residual reagents or serum
albumin on the inner wall of the lines, especially the residual materials
on the inner wall of flowing colorimetric cells. Fill distilled water into the
lines after washing.

3) Weekly maintenance

Wash the lines with distilled water several times and then aspirate the
cleaning solution once (main ingredient: sodium hypochlorite, diluted to
5%); after that, maintain the cleaning solution in the lines for ten
minutes and finally wash the lines with distilled water for three times.
Fill distilled water into the lines after washing. Neutral or alkaline
cleaning solutions are applicable to this instrument, but acidic cleaning
solution is prohibited.

4) Washing and disinfection of instrument surface

Washing: Dip a piece of wet towel with cleaning solution to wipe the
analyzer tabletop, until all the stains are removed. It is recommended
to perform this operation once a day.

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WP21 Series Operation Manual Chapter 7 Daily Use and Maintenance

Disinfection: Dip a piece of wet cloth with 75% alcohol or


pasteurization solution to wipe and disinfect the analyzer surface. It is
recommended to perform this operation once a week.

Note: Make sure to turn off the power switch and pull out the plug
before cleaning the analyzer housing. Please use clean water, neutral
cleansers or corrosion-free detergents for washing; do not use organic
solvents or hot water to avoid instrument damage due to deformity.

5) Waste disposal

The daily-generated wastes, including waste water, test tubes and


gloves, should be removed. All the wastes should be regarded as
medical wastes and disposed according to the regulations of the
hospital and local environmental protection agency.

Note: Make sure to turn off the power switch and pull out the plug
before cleaning the analyzer housing. Please use clean water,
neutral cleansers or corrosion-free detergents for washing. Do
not use organic solvents or hot water to avoid instrument damage
due to deformity.

7.2 Explanation about elimination or reduction of


instrument downtime
We provide the responsible personnel with specific explanations to
eliminate or reduce instrument downtime, and the risks in product
shipment or disposal. These explanations should include the
requirements about minimizing biological harm:

1) Serum, reagents and all the other liquids should be regarded as


contaminants. If a small amount of these materials spills on the
instrument surface, please wipe it off using a cotton ball dipped with
75% alcohol. Otherwise, touching the instrument’s surface may cause
biological risks such as infection. If a large amount of liquid splashes
and penetrates into the analyzer, please stop using the instrument and
pull out the power plug, and then contact Genrui or local
representative.

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WP21 Series Operation Manual Chapter 7 Daily Use and Maintenance

2) If the instrument needs to be moved, relocated, presented, lent or


repaired, thoroughly disinfect its surface to minimize the biological
harm. If the instrument is crashed or dropped, whether there is obvious
damage on its surface or inside, stop using it and contact Genrui or
local representative.

3) If there is an instrument breakdown after the warranty period, ask


Genrui’s service engineer, reparation engineer in the device
department of the hospital or other qualified engineers to repair it;
otherwise, there is the risk of electric shock. Please contact Genrui
before reparation.

4) When the expected service life of this instrument ends (about eight
years), it is recommended to stop using it or resume using after overall
troubleshooting, maintenance and care by Genrui.

5) This analyzer can only be used by personnel who are trained and
authorized by Genrui or its representative; otherwise, the protection
provided by the instrument may be impaired or the test results may be
significantly affected.

7.3 Preventive maintenance and inspection for safety


purpose
1) Check if the power cable is connected and well grounded before
startup.

2) Check if the isoelectric grounding rod is well connected before


startup.

3) Strictly comply with the maintenance requirements in the ―Daily Use


and Maintenance‖ section to perform the instrument maintenance and
service.

7.4 List of replaceable components


1) List of replaceable parts and consumable materials

Consumable materials: Printing paper, see Appendix 1

64
WP21 Series Operation Manual Chapter 7 Daily Use and Maintenance

Parts: None

2) List of parts that should be replaced by authorized service engineers

Fuse, with specifications of F3A250V

Power supply and the switch

PCB hardware system

7.5 Common faults and troubleshooting


Fault
Cause Analysis Troubleshooting
Description

No aspiration 1. The aspiration 1. The tightening screw at


pump does not the pump head is loose.
rotate Tighten the screw.

2. The pump tube is 2. Cut out a small part at


loose the connection of the
pump tube
3. The aspiration
volume is zero 3. Reset the correct
aspiration volume
4. The pump tube is
broken 4. Replace with a new
pump tube (see
Appendix 2)

No display on 1. The power switch 1. Turn on the power


the screen is off switch

2. The power supply 2. Reinsert the power


is unavailable plug

3. The display signal 3. Reinsert the display


cable is loose cable

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WP21 Series Operation Manual Chapter 7 Daily Use and Maintenance

Fault
Cause Analysis Troubleshooting
Description

The screen is The display contrast Adjust the contrast


blurred or too of the LCD changes regulator inside the
dark with the environment instrument

The printer 1. The printing paper 1. Replace with new


does not print is unavailable printing paper

2. The printing paper 2. Adjust the location of


is seized up after printing paper
paper tearing
3. Reinsert the printing
3. The heat-sensitive paper
printing paper is
inserted reversely 4. Print again after the
printer cools down
4. The printer
temperature is too
high

Failed to test 1. The absorbance 1. Test again with clean


the testing at a and fresh distilled water
absorbance specific
wavelength fails, 2.
but the testing at
other wavelengths A Remove the air
are normal: bubbles in the
cuvette
Distilled water is
not used B Wash the cuvette with
cleaning solution
2. The absorbance
testing at all the C Replace the
wavelengths fails: light-source lamp

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WP21 Series Operation Manual Chapter 7 Daily Use and Maintenance

Fault
Cause Analysis Troubleshooting
Description

A There are air


bubbles in the
cuvette

B The cuvette is
unclean

C The light-source
lamp is ageing

Unstable test 1. Not test 1. Test absorbance during


results absorbance system maintenance
during startup
2. Exchange for effective
2. The reagent is reagents
ineffective
3. Adjust the aspiration
3. The aspiration volume to make it ≥
volume is 600μL
insufficient
4. Measure the blank and
4. The standard is standard again
not tested
5. Use another
5. The wavelength is wavelength to measure
unavailable again

6. Air is aspirated 6. Carefully operate


carelessly during according to the related
operation requirements

If the instrument fault is still present, or there are other faults, please
contact our customer service division.

67
WP21 Series Operation Manual Chapter 8 Shipment and Storage

Chapter 8 Transportation and Storage


8.1 Transportation
This analyzer can be delivered by general transportation; however,
fierce impact, vibration, or exposure in rain or snow should be avoided
during shipment. Please make sure to place and transport the
instrument as per the related graphics on its outer packaging box. The
shipment requirements are determined according to the ordering
contract.

8.2 Storage
The packaged analyzer should be stored in a well-ventilated room that
has the environmental temperature of -10℃ to +55℃ and relative
humidity of 93% and is free from corrosive gases.

8.3 Graphic explanations on the outer package

——―Fragile‖: Carefully carry and place.

——―Up‖: Upward to place and transport the product.

—— ―Rain proof‖: Protect the package from the rain.

——―Layer limit‖: Maximum pile up layers of the same


package.
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WP21 Series Operation Manual Chapter 8 Shipment and Storage

——―Humidity limit‖: Humidity limit for transportation and


storage environment.

——―Temperature limit‖: Temperature limit for transportation


and storage environment.

Note: The illustrations are for reference only, subject to pictures on the
outer package.

69
WP21 Series Operation Manual Chapter 9 Commonly-used Consumables
and Ordering Information

Chapter 9 Commonly-used Consumables and

Ordering Information

During normal use and maintenance of this Semi-auto Chemistry


Analyzer, the required consumables are listed as follows:

No. Name Specification

Thermal
1 printing 80mm × 35mm
paper

Light-source
2 6V/10W, PHILIP, 6605, G4
lamp

3 Pump tube φ4mm × φ2mm × 320mm

Aspiration
4 φ1.5mm × φ0.8mm
tube

Connection
5 φ3mm × φ1.0mm
tube

6 Cuvette 10mm quartz flow cell

7 Filter 340nm

8 Filter 380nm

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WP21 Series Operation Manual Chapter 9 Commonly-used Consumables
and Ordering Information

No. Name Specification

9 Filter 405nm

10 Filter 505nm

11 Filter 546nm

12 Filter 578nm

13 Filter 620nm

14 Filter 700nm

1.8m, three-core power


15 Power cable cable compliant with the
national standard in China

16 Fuse 3A, φ5mm × 20mm

Ordering method

1. Order via the local distributors of the consumable materials.

2. Order from the manufacturer by phone.

Ordering hotline: +86 755 26835560

Fax: +86 755 26678789

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WP21 Series Operation Manual Appendix

Appendix
Appendix 1 Replace printing paper
1. Open the printer cover and remove the roller (first take out the
terminal without gears and then the other terminal with gears;
please handle them gently), and take out the residual printing
paper.

2. Put the paper roll into the paper trough. Please note that there are
differences between the sides of thermal printing paper. Please
make sure the thermal side faces downward. Place the printing
paper below the roller, as illustrated in the figure below. Please
ensure that the movement direction of the printing paper should be
vertical with the roller orientation, thereby avoiding inability of
normal printing due to paper jam.

Printer cover Paper outlet

Paper slot Paper roll

Non-thermal
Paper roller
side upward

Figure 12-1 Diagram for installation of printing paper

3. Install the roller: First make the terminal with gears aligned and
then gently press down the other terminal.

4. Press the ―Feed‖ key, observe whether the paper moves smoothly
and the printer roller is vertical. Adjust it as needed. When a
segment of the printing paper moves out of the printer (passing the
printer cover), press the ―Feed‖ key again to stop it.

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WP21 Series Operation Manual Appendix

5. Pull out the printing paper from the paper outlet at the printer cover
and close the cover.

Note: The “Feed” key is available on the main interface, all the
screens waiting for keyboard entering, the “Print/Delete Result
Reports” window in the “Result Report” interface and the QC
report interface. This function is disabled on all the other
interfaces to protect the printer.

Appendix 2 Replace pump tubes


The peristaltic pump is located at the rear cover of the bottom plate, as
illustrated in Figure 13-1.

1. Hold the connector of the pump tube with a hand, and then
remove the liquid inlet pipe and the waste liquid pipe.

2. Take out the pump tube from the peristaltic pump.

3. Remove the tube connector outside the pump tube.

4. Get a new pump tube and fix the connector at an appropriate


location of the new tube.

5. Install the new tube as per the reverse steps of removing it. Let the
tube slide along the gap of the tube rack into the fixation trough.

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WP21 Series Operation Manual Appendix

Peristaltic Housing

pump
tube

Waste
liquid
pipe

Bottom

Peristaltic Finger-like Pump tube Liquid plate

pump rack of the connector inlet pipe


liquid tube

Figure 13-1 Structure of the peristaltic pump

Appendix 3 Clean the cuvette


1. Prepare a glass of distilled water or alcohol and place the sample
tube into it.

2. Press ―6‖ on the main interface to open the ―Maintain‖ window and
then press ―5‖ to enter the ―ADC ADJ‖ interface.

3. Press ―1‖ to start cleaning.

4. For alcohol cleaning, after completion, use distilled water to wash


twice.

5. After cleaning, press ―Exit‖ to return to the main menu.

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WP21 Series Operation Manual Appendix

Appendix 4 COM communication


Hardware conditions: Connect the RS-232C ports of the two
instruments needing to be communicated by RS-232C cable, or
connect the instrument with the COM port of the computer. This
instrument provides the following options about COM status:

Connection: If you want to perform data exchanges with a computer,


please connect a standard RS-232 cable with the ―COM RS232 1‖ port
at the rear of the instrument, and connect the other terminal with the
COM at the rear of the computer.

Please set up as per the following steps:

Baud rate: 115200, 57600, 38400, 19200, 9600

Parity check: Odd, Even, None

Working status: On, Off

Item code (Items 001~200; at most 200 items):

No. Item Code No. Item Code

1 1 8 8

2 2 9 9

3 3 10 10

4 4 11 11

5 5 …… ……

6 6 …… ……

7 7 …… ……

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WP21 Series Operation Manual Appendix

Explanation about COM communication:

1. All the data sent is encoded with Code ASCII, e.g. using COM
tools to switch to the character format.

2. Each item name or number is followed at least one blank space

Analysis of a typical frame:

After printing assay results or measuring a sample and QC, the


instrument will send a series of character data from the RS-232 serial
port, as illustrated below:

Normal mode

┐1 1 3 20120214152114 No 00173 ID 00000000001752 001 ALT 1.08


u/mL 1.20 2.31 ∟

QC mode

┐1 1 3 20120214153928 No 00006 LN 00000000003699 001 ALT


2.21 u/mL 2.20 2.55 ∟

The analysis is as follows:

Frame head: 02H

Version number: 1

Instrument type: 1

Instrument No.: 3 (Semi-auto Chemistry Analyzer)

Measurement time: 20120214202114 (February 14, 2012, 20:21:14)

No.: 00173

ID number: 00000000001752 (displaying LN during QC


measurement)

Item number: 1

76
WP21 Series Operation Manual Appendix

Item abbreviation: ALT

Measurement result: 1.08

Unit: μ/mL

Range: 1.20--2.31

Frame tail: 03H

Appendix 5 List of test items and test combinations


The following 54 test items are built in this instrument:

Item Item
Abbreviation Name Abbreviation Name
No. No.

Alanine Serum
1 ALT 24 Mg
transaminase magnesium

Alkaline
2 ALP 25 Cu Serum copper
phosphatase

Glutamic
3 GOT oxaloacetic 26 Zn Serum zinc
transaminase

γ-glutamyl Serum
4 γ-GT 27 P
transpeptidase phosphorus

5 TP Total protein 28 K Serum potassium

6 ALB Albumin 29 Na Serum sodium

Total iron-binding
7 TBIL Total bilirubin 30 TIBC
capacity

8 DBIL Direct bilirubin 31 Fe Serum iron

9 TTT Thymol enzyme 32 HGB Hemoglobin

Blood urea Red blood cell


10 BUN 33 RBC
nitrogen count

77
WP21 Series Operation Manual Appendix

Item Item
Abbreviation Name Abbreviation Name
No. No.

11 CRE Creatinine 34 GRP Globulin

Albumin/
12 UA Uric acid 35 A/G
globulin ratio

Carbon-dioxide
13 CO2 36 UDBIL Indirect bilirubin
combining power

Immuno-
14 NH3 Blood ammonia 37 IGG
globulin G

Immuno-
15 GLU Blood glucose 38 IGM
globulin M

16 TCHO Total cholesterol 39 C3 Complement C3

High density
17 HDLC 40 CHE Cholinesterase
lipoprotein

Low density
18 LDLC 41 CK Creatine kinase
lipoprotein

19 TG Triglyceride 42 BU Blood urea

Lactic Creatine kinase


20 LDH 43 CK-MB
dehydrogenase isoenzyme

α-hydroxybutyric
21 AMS Amylase 44 α -HBDH
dehydrogenase

22 CL Serum chloride 45 LQS Lipase

Monoamine
23 Ca Serum calcium 46 MAO
oxidase

Each test item should be tested with the corresponding reagent kit.

78
WP21 Series Operation Manual Appendix

The test combinations built-in this instrument and their respective test
items are as follows:

Alanine transaminase, alkaline phosphatase,


glutamic oxaloacetic transaminase, γ-glutamyl
Liver function
transpeptidase, total protein, albumin, total
tests
bilirubin, direct bilirubin, thymol enzyme, globulin,
albumin/globulin ratio, indirect bilirubin

Kidney function Blood urea nitrogen, urea, uric acid, creatinine,


tests carbon-dioxide binding capacity

Serum potassium, serum sodium, serum chloride,


Ion testing
serum calcium, serum iron, serum magnesium,
items
serum copper, serum zinc, serum phosphorus

Blood lipid High density lipoprotein, low density liproprotein,


items cholesterol, triglyceride

Creatine kinase, cholinesterase, creatin kinase


Heart function
isoenzyme, lactic dehydrogenase,
tests
α-hydroxybutyric dehydrogenase

Immunological Immunoglobulin G, immunoglobulin M,


items complement C3

Blood ammonia, blood glucose, amylase,


Other items iron-binding capacity, hemoglobin, red-blood-cell
count, lipase, monoamine oxidase

79
WP21 Series Operation Manual Appendix

Appendix 6 Hazardous substances


Hazardous substances
Parts name
Pb Hg Cd Cr(VI) PBB PBDE

Host shell ○ ○ ○ ○ ○ ○

Host PCBA ×(1) ○ ○ ○ ○ ○

Host sheet metal parts ○ ○ ○ ○ ○ ○

Host machining part ○ ○ ○ ○ ○ ○


Host
Host plastic pieces ○ ○ ○ ○ ○ ○

Host metal pieces ○ ○ ○ ○ ○ ○

Host connection cable ○ ○ ○ ○ ○ ○

Host fluid path


components

Labels ○ ○ ○ ○ ○ ○

Closure assembly ○ ○ ○ ○ ○ ○
Accessories
Maintenance tools ○ ○ ○ ○ ○ ○

Inlet transfer assembly

80
WP21 Series Operation Manual Appendix

Hazardous substances
Parts name
Pb Hg Cd Cr(VI) PBB PBDE

Package Packaging materials ○ ○ ○ ○ ○ ○

○: means the content of the hazardous substance in all homogeneous materials of the
part is in the limited requirement according to the standard of SJ/T 11363-2006.
×: means the content of the hazardous substance in at least one of the homogeneous
materials of the part is beyond the limited requirement according to the standard of SJ/T
11363-2006.
(1): some parts of the circuit board used lead solder during processing.
Notice: the product marked with ―×‖ is because there has no other technologies or parts
to be replaced at present stage, under normal use conditions, leak and mutation will not
occur in 5 years, and it will not cause environment pollution or harm to people and
property.

81
P01. 91. 300077- 04

Add: 6F, Shanshui BuildingB, Nanshan Yungu Innovation Industrial Park, 1183 Liuxian Blvd,
Nanshan District, 518055, Shenzhen, P.R. China
TEL: +86 755-2683 5560 FAX: +86 755-2667 8789
E- mail: [email protected] WEB: www.genrui-bio.com

Well Kang Limited


EC REP The Black Church, St. Mary’s Place, Dublin 7, Ireland
www.CE-Marking.EU

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