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NOTE:

1) Carefully read this manual before operating the analyzer in first


time.
2) Inspect the electrical requirements of the analyzer before power
on, and properly connect the grounding wire.
3) Turn off the power t and pull out the power plug if the analyzer is
idle for a long time.
4) Do not run the analyzer if it’s in an abnormal or damaged
condition.
5) There is potential biohazard of the reagents and samples;
operator should follow proper biosafety practices. Dispose of
waste reagent and sample in accordance with local, national
regulations.

1
Contents
Contents ......................................................................................................................................... I
Copyright and Declaration ..........................................................................................................i
Guidance ...................................................................................................................................... iii
Chapter 1 System Description ............................................................................................. 1
1.1 Overview .................................................................................................................. 1
1.1.1 Intended Use and Function........................................................................ 1
1.1.2 Scope of Application ................................................................................... 1
1.1.3 Front Panel ..................................................................................................... 1
1.1.4 Side Panel ...................................................................................................... 2
1.2 Parameters ............................................................................................................... 3
1.3 Structure .................................................................................................................. 4
1.3.1 Optical Detection System ........................................................................... 4
1.3.2 Flow System .................................................................................................. 4
1.3.3 Control System ............................................................................................. 4
1.3.4 Identification Software ................................................................................ 5
1.3.5 Mechanical Device ....................................................................................... 5
1.3.6 Input & Output ............................................................................................... 5
1.4 Tube Rack ................................................................................................................ 5
1.5 Reagent & Sample Consumption ........................................................................... 5
1.6 Test Speed ................................................................................................................ 6
1.7 Storage Capacity ..................................................................................................... 6
1.8 Storage and Transportation Environment ............................................................ 6
1.9 Normal Use Environment ....................................................................................... 6
1.10 Electrical Requirement ........................................................................................... 6
1.11 Reagent..................................................................................................................... 6
1.11.1 Detergent A .................................................................................................... 7
1.11.2 Detergent B .................................................................................................... 7
1.11.3 Control and Calibrator ................................................................................ 7
Chapter 2 Installation and Menu .......................................................................................... 8
2.1 Unpacking and Inspection ...................................................................................... 8
2.2 Installation Requirements ...................................................................................... 8
2.3 Sampling Station Installation ................................................................................. 9
2.4 Power Supply Inspection ........................................................................................ 9
2.5 Tubing Installation ................................................................................................ 10
2.5.1 DETERGENT A Tubing Installation ........................................................ 10
2.5.2 DETERGENT B Tubing Installation ........................................................ 10
2.5.3 WASTE Tubing Installation ...................................................................... 10
2.6 Printer Installation (optional) .............................................................................. 11
2.7 Display, Keyboard and Mouse Installation ......................................................... 11
2.8 Power Connection ................................................................................................. 11
2.9 Startup.................................................................................................................... 11
2.9.1 System Menu ............................................................................................... 12

I
2.9.2 Tip Area ......................................................................................................... 16
2.9.3 Status Bar ..................................................................................................... 16
2.10 Microscope Setup .................................................................................................. 17
Chapter 3 Daily Operation ................................................................................................... 19
3.1 Overview ................................................................................................................ 19
3.2 Preparation ............................................................................................................ 19
3.3 Log In ..................................................................................................................... 20
3.4 Quality Control and Calibration ......................................................................... 21
3.4.1 Quality Control ............................................................................................ 21
3.4.2 Calibration .................................................................................................... 22
3.5 Sample Analysis ..................................................................................................... 22
3.5.1 Daily Test Interface .................................................................................... 22
3.5.2 Query and Status ........................................................................................ 22
3.5.3 Microscopy Test.......................................................................................... 24
3.5.4 Thumbnail Browse ..................................................................................... 25
3.5.5 Artificial classification .............................................................................. 26
3.5.6 RBC Phase ................................................................................................... 29
3.5.7 Patient Information Input.......................................................................... 30
3.5.8 Urinalysis Match ......................................................................................... 31
3.5.9 Print Report.................................................................................................. 32
3.5.10 Send ............................................................................................................... 33
3.6 Shutdown ............................................................................................................... 33
Chapter 4 Maintenance and Settings ............................................................................... 35
4.1 Maintenance .......................................................................................................... 35
4.1.1 General information area.......................................................................... 35
4.1.2 Common Function area ............................................................................ 35
4.1.3 Error List ....................................................................................................... 36
4.2 Settings ................................................................................................................... 37
4.2.1 Video area..................................................................................................... 37
4.2.2 Setting area .................................................................................................. 37
4.2.3 Order Operation .......................................................................................... 39
4.2.4 Test Area ....................................................................................................... 40
4.2.5 Horizontal Platform .................................................................................... 41
4.2.6 Focusing Settings ...................................................................................... 44
4.3 General Settings .................................................................................................... 45
4.4 Maintenance .......................................................................................................... 47
4.5 Microscopy Settings .............................................................................................. 48
4.5.1 Microscope Parameters ............................................................................ 48
4.5.2 Threshold ..................................................................................................... 49
4.5.3 Sample Volume ........................................................................................... 49
4.5.4 Urinalysis Settings ..................................................................................... 50
4.5.5 Urinalysis parameter ................................................................................. 52
4.5.6 Urinalysis Gating ........................................................................................ 52
4.6 Dictionary maintenance ........................................................................................ 54
4.6.1 Send Information ........................................................................................ 54

II
4.6.2 Sample and Patient Type .......................................................................... 54
4.6.3 User Registration ....................................................................................... 55
4.7 Print Setting ........................................................................................................... 55
4.7.1 Page ............................................................................................................... 55
4.7.2 Print Parameters ......................................................................................... 56
4.8 Send ........................................................................................................................ 57
4.9 Control Setting ...................................................................................................... 57
Chapter 5 Quality Control .................................................................................................... 59
5.1 Overview ................................................................................................................ 59
5.2 QC Interface .......................................................................................................... 59
5.3 QC setting .............................................................................................................. 60
5.4 Calculation method ............................................................................................... 60
5.5 QC Test ................................................................................................................... 60
5.6 QC Print ................................................................................................................. 61
Chapter 6 Calibration ............................................................................................................ 62
6.1 Overview ................................................................................................................ 62
6.2 Interface and Operation ....................................................................................... 62
6.3 Microscope Calibration ........................................................................................ 63
6.4 Calibrator Calibration .......................................................................................... 63
6.4.1 Use ................................................................................................................. 63
6.4.2 Method .......................................................................................................... 63
Chapter 7 Others .................................................................................................................... 66
7.1 Statistics ................................................................................................................. 66
7.2 Data Recovery........................................................................................................ 66
Chapter 8 Troubleshooting ................................................................................................. 68
8.1 Troubleshooting Guidance.................................................................................... 68
8.2 Obtaining Technical Assistance ............................................................................ 68
8.3 Troubleshooting ..................................................................................................... 69
8.3.1 Startup Error ................................................................................................ 69
8.3.2 Not display ................................................................................................... 69
8.3.3 Mouse Error ................................................................................................. 69
8.3.4 Keyboard Error ........................................................................................... 70
8.3.5 Printer error ................................................................................................. 70
8.3.6 No Rinse ....................................................................................................... 70
8.3.7 Waste full ...................................................................................................... 71
Chapter 9 Precautions, Limitations and Hazards.......................................................... 72
9.1 Limitations ............................................................................................................. 72
9.2 Installation Limitations ........................................................................................ 72
9.3 Personnel Protection and Infection Control ....................................................... 73
Appendix A: Instrument Icon and Symbols Specification............................................... 74
Appendix B: Instrument Specifications ............................................................................... 75
Appendix C: Trouble List ......................................................................................................... 76
Appendix D: Parts List for Replacement.............................................................................. 77
Appendix E: HL7 Protocol for URIT-1280 ............................................................................. 78

III
Copyright and Declaration

Copyright © URIT Medical Electronic Co., Ltd.


Declaration:
All contents in this manual were strictly compiled according to related laws
and regulations in China, as well as the specific condition of URIT-1280 Auto
Urine Sediment Analyzer, covering all the updated information before printing.
URIT Medical Electronic Co., Ltd. is fully responsible for the revision and
explanation of the manual, and reserves the right to renovate the relevant
contents without separate notification. Some of the demonstration pictures are
for reference and subject to real object if any differences.
All the information included is protected by copyright. No part of this
document may be reproduced, stored or transmitted in any form or by any
means unless written authorization by URIT Medical Electronic Co., Ltd..
All instructions must be followed strictly in operation. In no event should
URIT Medical Electronic Co., Ltd. be responsible for failures, errors and other
liabilities resulting from user's noncompliance with the procedures and
precautions outlined herein.
Limited Responsibility for Quality Warranty:
The manual for URIT-1280 Auto Urine Sediment Analyzer, defines the
rights and obligations between the URIT and the customers about the
responsibility for quality warranty and after-sale service, also the related
agreements on commencement and termination.
URIT warrants the URIT-1280 sold by the URIT and its authorized agents
to be free from defects in workmanship and materials during normal use by the
original purchaser. This warranty shall continue for a period of one year since
the date of installation. The analyzer life is ten years.
URIT assumes no liability in the following situations even during the period
of warranty:
a) Failure due to abuse the analyzer or neglect the maintenance.
b) Use reagents and accessories other than manufactured or recommended
by URIT.
c) Failure due to operation not under the instructions described in the manual.
d) Replace accessories not specified by URIT, or after maintenance or repair
by a service agent not approved or authorized by URIT

i
CAUTION:
THE
E ANALY
YZER IS FOR
F PRO
OFESSION
NAL AND PRESCR
RIPTION USE
U
ONLY.
Technical service and
a troubleshooting are providded by UR RIT Custo omer
Suppport Centeer. Professsional technician and
d sale repre
esentative will be sen
nt to
offe
er you time
ely service when nece essary.

URIT Medical
M Ele
ectronic Co
o., Ltd.

No..D-07 Inforrmation Ind Tech Zone, Guilin, Gu


dustry Distrrict, High-T uangxi 541004,

P. R.
R China

Tel:: +86(773)2
2288586
Faxx: +86(773)2288560
Web: www.urit.com
Email:service@uritest.ccom

Wellkang Ltd t/a Wellkang Tech Consultin


ng
Suite B, 29
9 Harley Street,
S LON
NDON W1G
G 9QR, UK
K

Verrsion : 07/2
2013-C1

ii
Guidance

General information for the operation of the analyzer is contained in this


manual, which covers the best guidance for a new operator to master the
characteristics of the analyzer and operation methods, as well as for daily
inquiry. Do peruse before first operation.

This manual uses the following warning conventions:

WARNING
Denotes a hazard which, if not avoided, could result in moderate to
serious injury.

CAUTION
Denotes potential hazards that could result in a minor injury, also used for
conditions or activities which could interfere with proper function of the
analyzer.

WARNING
Denotes potential bio-hazard.

NOTE:
Denotes special operator/service information or standard practices.

Do read through this manual before operation, maintenance,


displacement to the analyzer.

iii
Chapter 1 System Description

1.1 Overview

URIT-1280 Auto Urine Sediment Analyzer (hereinafter referred to as


Analyzer) which uses the digital imaging automatic recognition theory is an
integrated facility that applies any techniques referring to electricity, optics,
identification software and mechanism. The Analyzer is an in vitro diagnostic
medical device, mainly used in clinical counting and analysis of Urine
Sediment. This analyzer can recognize the urine visible components through
the images and get the test results, which provide the necessary reference to
clinical diagnosis.

1.1.1 Intended Use and Function

URIT-1280 Auto Urine Sediment Analyzer applies to the qualitative and


quantitative analysis of the urine sediment, getting and recognizing the
quantitative sample images to obtain the results of red blood cells, white blood
cells, epithelium, casts, crystal, squamous cells, atypical squamous cells, germ,
microzyme, viscose silk, semen etc.

1.1.2 Scope of Application

It applies to quantitative analyze urine sediment.

1.1.3 Front Panel

Figure 1-1 Front Panel

1
System Description

1. Channel indicators
Green light: on standby; Green BLN control-Pro: instrument dormancy;
Red twinkle: in process; Red light: alarm.
2. Sample Loader
Sample loader can hold 50 samples once for continuous test (100
samples can be held in single cycle mode).

3. STAT sample position


If one or more STAT samples need to be inserted during the consecutive
samples testing, place it in this position for test in advance.

1.1.4 Side Panel

Figure 1-2 Side Panel


1. Side Door Lock

There are two locks on the side door; press and turn the locks to open it.
2. Reagent Ports
It’s used to connect the external reagents and drain the waste. Figure 1-3
depicts the detailed ports as hereunder.

2
System Description

Figure 1-3 Reagent Panel

(1)DETERGENT A
Detergent A port connects to the detergent inlet tube.
(2)DETERGENT B
Detergent B port connects to the detergent inlet tube.
(3)SENSOR
Waste sensor port connects to the waste sensor, used to detect whether
the waste bottle is full.
(4)WASTE
Waste port connects to the waste outlet tube, drain waste out of the analyzer.

1.2 Parameters

This analyzer can take and store pictures of test sample automatically,
and give the quantitative or qualitative report according to the following tables.
Table 1-1 Machine recognition item parameters
Abbreviation Full Name
RBC Red Blood Cell
WBC White Blood Cell
SQEP Squamous Cell
NSE Non-squamous Epithelial Cells
HYA Cast
GRAN Hyaline Cast
CAOX Calcium Oxalate Crystal
BACT Bacteria
YST Yeast
URIC Uric acid Crystal
MUCS Mucus

3
System Description

Table 1-2 Manual recognition item parameters


UNCC Uncategorized Cast
WAXY Waxy Cast
CELL Cell Cast
SPRM Sperm
MYCETE Mycete
CAPH Calcium phosphate crystal
CACB Calcium Carbonate Crystal
UNCX Unclassified Crystal
WBCC White Blood Cell Cluster
RBCA Wizened Red Blood Cell
RBCG Tumid Red Blood Cell
IMPURITY Impurity
UNDF Unclassified Particle

1.3 Structure

The analyzer consists of optical detection system, flow system, control


systems, identification software, mechanical devices and input and output
components.

1.3.1 Optical Detection System

The optical detection system is composed of infinity flat field achromatic


lens, optic fiber lighting device, COMS camera and optical frame.

1.3.2 Flow System

The flow system is composed of solenoid valves, vacuum pump, force


pump, vacuum chamber and plastic tube.
Solenoid Valve--- These contact two-way or three-way solenoid valves
control the flow of reagent.
Pump --- Pump the waste generated in the processing out of the analyzer.
Plastic Tube --- Reagent and waste flow in the plastic tube.
Vacuum Chamber--- Generate negative pressure and play the role of
temporary waste reservoir.

1.3.3 Control System

The control system mainly divided into information processor device, flow
control device and switch power supply device.
4
System Description

1.3.3.1 Information Processor Device

Information processor device is consisted by a set of multi-core


processors, which can take the computing tasks of numerous images, to
ensure a fast batch sample image processing.

1.3.3.2 Flow Control Device

This part controls analyzer auto sampling, is responsible for the pump and
valve switch of the flow to ensure a quick and accurate image collection.

1.3.4 Identification Software

The identification software is used for processing, identifying and


classifying the sample photos.

1.3.5 Mechanical Device

The Mechanical device is consisted by sample deliver device, sampling


device, circuit mounting bracket and microscope column.

1.3.6 Input & Output

It includes the display, keyboard, print, reagent and liquid waste container.
URIT-1280 adopts a 22-inch LCD with DVI-D video mode.(Do not use other
display specifications.)

1.4 Tube Rack

The test tube rack is for the analyzer dedicated, there are 10 pieces of
standard urine visible component tube on it.

1.5 Reagent & Sample Consumption

Urine sediment (or original urine):1.2mL;


Detergent A: 7.5mL;
Detergent B: 15 mL;
Reagent consumption is various according to the software version.

5
System Description

1.6 Test Speed

URIT-1280 is able to process 70- 100 samples per hour.

1.7 Storage Capacity

URIT-1280 contains a memorizer which can store more than 50,000


samples data.

1.8 Storage and Transportation Environment

a) Temperature: -20℃~55℃
b) Relative Humidity: ≤93%RH
c) Barometric: 86kPa~106kPa

1.9 Normal Use Environment

a) Temperature: 5℃~40℃
b) Relative Humidity: ≤85%RH
c) Barometric: 75kPa~106kPa

1.10 Electrical Requirement

Supply: AC 100V ~240V


Frequency: 50/60Hz
Fuse: T3.15AL250V
Power: 150~220 VA

1.11 Reagent

The reagent is formulated specifically for the URIT-1280 flow systems in


order to provide optimal system performance. Use of reagents other than
those specified in this manual is not recommended as analyzer performance
can be affected. Each URIT-1280 is checked at the factory using the specified
reagents and all performance claims were generated using these reagents.
Thus non-URIT reagents will lead to defects in the performance of the analyzer
and serious mistakes, even accidents.

6
System Description

Reagents must be stored at room temperature to ensure optimal


performance. All reagents should be protected from direct sunlight, extreme
heat, and freezing during storage. Temperatures below 0℃ may cause reagent
layering, which changes the tonicity and conductivity of the reagents.
The reagent inlet tubes have a cap attached that minimizes evaporation
and contamination during use. However, reagent quality may deteriorate with
time. Therefore, use all reagents within the dating period.

1.11.1 Detergent A

Detergent A is mainly used for daily cleaning of flow system and sample
dilution. It is used for rinse after each sample test.

1.11.2 Detergent B

Detergent B is mainly used for intensive cleaning of flow system. If


counting chamber is too contaminated to clean up by detergent A, use
detergent B to flush the chamber. It’s recommended to perform flush operation
for 1 or 2 times a week.

1.11.3 Control and Calibrator

Control and calibrator are for quality test and calibration. Control is a kind
of industrial reagent products,which is used to test whether the counting is
normal or not. Calibrator is also a kind of industrial reagent products for
calibration. Operation and storage methods please refer to the instruction of
control and calibrator.
The "control" and "calibrator" mentioned in this manual refer to the special
control and calibrator assigned by URIT. Users can purchase from URIT or
agents designated by URIT.

7
Chapter 2 Installation and Menu

Initial installation of analyzer must be performed by a URIT authorized


engineer or representative to ensure that all system components are
functioning correct and to verify system performance. Installation procedures
must be repeated if the analyzer is moved from the original installation site.
NOTE:
Installation of the analyzer by unauthorized or untrained personnel by
URIT could result in damage to the analyzer which is exclusive of the warranty.
Never attempt to install and operate the analyzer without a URIT authorized
representative.

2.1 Unpacking and Inspection

Carefully remove the analyzer and accessories from shipping carton, keep
the kit for further transport or storage. Check the following:
1) Quantity of accessories according to the packing list;
2) Leakage or soakage;
3) Mechanical damage;
4) Bare lead, inserts and accessories.
Do contact URIT Customer Support Center if any problem occurs.

2.2 Installation Requirements

Please refer to section 9.2 of chapter 9.

WARNING

Not for home use.


Not for therapy.

CAUTION

Keep the analyzer away from direct sunlight.


Avoid temperature extreme.

8
Installation and Menu

Keep away from centrifuge, X-ray equipment, display or copier.


No cell phone, wireless phone or equipments with strong radiation, which will
interfere with the normal operation of the analyzer.
The side lock door cannot be opened during the test.
Keep no less than 20cm distance at the right side switch.

2.3 Sampling Station Installation

Figure 2-1 Side Panel


1) Make sure that the single line between analyzer and sampling station are
connected. (See 1 in figure2-1)
2) Make the hooks on both side of sampling station snap in the analyzer.

2.4 Power Supply Inspection

Be sure that the system is located at the desired site before attempting
any connections. See Table 2-1 for details.
Table 2-1 Power Supply Requirements

Voltage Range Frequency


AC100V~240 V 50/60Hz

9
Installation and Menu

CAUTION

It’s not allowed to pour the waste into sewer tunnels unless it’s treated in
biological way. All hospitals and labs have a duty to comply with related
regulations.

2.5 Tubing Installation

There are four tube-connectors on the rear panel: DETERGENT A,


DETERGENT B, DEY and WASTE, each of which is wrapped with a cap to
avoid contamination by the URIT before shipment. Uncover and set the caps
aside carefully for further use on initial installation.

2.5.1 DETERGENT A Tubing Installation

Remove the detergent A tube with green faucet from reagent kit and
attach it to DETERGENT A connector on the rear panel. Place the other end
into the detergent A container. Twist the cap until secure. Place the container
on the same level as the analyzer.

2.5.2 DETERGENT B Tubing Installation

Remove the detergent B tube with blue faucet from reagent kit and attach
it to DETERGENT B connector on the rear panel. Place the other end into the
detergent B container. Twist the cap until secure. Place the container on the
same level as the analyzer.

2.5.3 WASTE Tubing Installation

Remove the waste tube with black faucet from reagent kit and attach it to
WASTE connector on the rear panel, connect BNC plug with the socket
marked “SENSOR” on the rear panel. Twist the tube’s cap clockwise onto the
waste container until secure. Place the container on the level at least 50cm
lower than the analyzer.

WARNING

Keep all lines in the natural state after installation. Do not forcibly twist.
Do not use any tools but with hand to install the line joints.

If found any abnormal occurrences, such as reagent bottles broken, weeping


10
Installation and Menu

or beyond warranty period, please stop use it and contact with the URIT local
office or after sale service department for changing.

To prevent waste liquid damage to the environment, it is forbidden to pull it


directly into the sewer. The waste liquid should be treated with biological or
chemical processing before discharging into sewer. It is an obligation for
hospitals and labs to abide by the relevant regulations of local government
department of environmental protection.

2.6 Printer Installation (optional)

Take out the printer carefully, and then check it according with the
requirements of Specification and 2.1 of Chapter 2. Install it according to the
steps as below.
1) We suggest you put the printer at the right side of the analyzer and keep it in
a 30cm-distance.
2) Install the telecommunication cables and other parts according to the Printer
Specification.
3) Connect one end of print cable with the printer, and the other with the USE
socket or the PRINTER socket in the analyzer.
4) Make sure that the power is shut off. Insert the plug into the socket.
5) Put the printing paper according to the Operation Guide.

2.7 Display, Keyboard and Mouse Installation

Remove display, keyboard and mouse from the shipping carton, and
insert the Bluetooth transmitter plugs of keyboard and mouse into the “USB4”
at the back of analyzer, then connect the display to the rear panel with “DVI-D”.
It is recommended to place the keyboard beneath the display.

2.8 Power Connection

Make sure the power switch is OFF (O) and the grounding terminal on the
rear panel is well grounded firstly, and then connect the analyzer to the main
power with the power cable.

2.9 Startup

Connect the power plugs of host and display, turn on the display and the
power switch on the rear panel of the host, the computer startups and enters
11
Installation and Menu

into WINDOWS system. The analyzer begins to initialize after selecting a user
name and inputting a password. When self-test, the analyzer will initialize the
database, port, video cards and motor.
After self-test, the analyzer enters into a test interface which is shown in
Figure 2-2.

Figure2-2 Test Interface

Toolbar: Report, Calibration, QC, Maintenance, Start, Stop, Rinse and Off.
Status bar: Present test mode, Checker, Urinalysis information, time and Date

2.9.1 System Menu

there is a System menu at the right lower corner in each interface, which
is as shown in Figure 2-3:

Figure 2-3 System Menu

12
Insta
allation and Menu
M

HELP: popup ‘help’ wind


dow shown
n in Figure
e 2-4

Fiigure 2-4 he
elp

MA
AP: popup the
t photo samples
s off all kinds of
o cells. Se
ee Figure 2
2-5 for deta
ails.

13
Installation and Menu

Figure 2-5 map

ABOUT: popup version information of software and hardware, please see


Figure 2-6.

Figure 2-6 about

Change password: Modify the logging on user's password. See figure 2-7.

14
Installation and Menu

Figure 2-7 Change passwords

Register Detergent: Register the software for the first time installation.
There are two methods for registering, one is to enter the registration code
printed on bottle cap of detergent (Figure 2-8), the other is to activate it with the
resgistration card (Figure 2-9).

Figure 2-8

Figure 2-9
15
Installation and Menu

Logout: Switch user.


Quit: Quit system test interface. See figure 2-10. See 3.6 of Chapter 3 for
details.

Figure 2-10 Quit

Setting: all kinds of setting of URIT-1280. Check Chapter 4 for details.

2.9.2 Tip Area

In each interface, there is a tip area at the right lower corner as shown in
figure 2-11.

Figure 2-11 Tip Area

Lamp: green means free; orange twinkle means busy, red means that
there’s a problem, and yellow BLN control-Po means dormant state.
Frame: it will appear all sorts of prompt information, such as successful
saving, successful urinalysis, input error, etc. Generally, tip word is blue,
warning word is orange, and error is with the scarlet letter.

2.9.3 Status Bar

There is a status bar in the bottom of each interface as shown in figure


2-12.

Figure 2-12 Status Bar

16
Installation and Menu

The contents are following from left to right:


Content 1: It shows welcome information generally. It will also show prompt
information, such as the detergent needs re-registration,
insufficient space on the hard disk and serial port and video are not
opened.
Content 2: Urinalysis port information. Enter into Urinalysis interface directly by
clicking here.
Content 3: Analyzer status information, such as common test, QC, calibration,
aging, free and dormant.
Content 4: User name of operator.
Content 5: Present time.

2.10 Microscope Setup

Figure2-13 open left side door Figure 2-14 tear down screws

Firstly pressing down the lock of the left side door (Figure 2-13) and
rotating rightward the pop-up part of the lock, then you can open the left side
door.
Both of the microscope lenses are fixed in order to ensure the safety
during the transportation. Unlade the two fixed mounts at the first use, and
check whether the lens is loose.
From test interface screen, click “Focus Point” to remove the microscope
stage to the counting chamber for focusing,rotate and adjust the coarse
focus adjustment until the grid image of the focus appears in the picture.

17
Installation and Menu

CAUTION

If the analyzer needs long-distance transportation after use, please lock the
holders of microscope lens and camera so as not to cause the loosening of
microscope and camera.

18
Chapter 3 Daily Operation

3.1 Overview

This chapter presents the whole daily operation process from startup to
shut down and emphasizes on sample analysis.
The procedure of daily operation is as follows:

Preparation

Log In

Calibration
QC
Uncontrolled
Controlled

Sample Analysis

Rinse and Shut


Down

3.2 Preparation

Before startup, the operator must check the analyzer according to the
following requirements to make the analyzer ready.
 Waste Chamber
Before startup, operator needs to check the waste chamber to ensure it is
already empty or has enough capacity.
 Tubes and Power Supply
Check whether the reagent tube and waste tube are connected firmly and

19
Daily Operation

without bending.
Check whether the power plug is well inserted into the power socket.
 Printer
Check whether the printer is installed well, power supply and cable is
connected well, and whether the printing paper is enough.
 Keyboard, Mouse and Display
Check whether the cable of keyboard, mouse and display is well
connected with analyzer.

3.3 Log In

As turning on the power switch on rear panel, the indicator twinkles and
the instrument begins to self-check. After self-checking, AUTOMATIC URINE
SEDIMENT ANALYZER software will run automatically, the loading interface
appears as shown in Figure 3-1

Figure 3-1 Loading Interface

Log in interface is shown in Figure 3-2.

20
Daily Operation

Figure 3-2 Log in Interface

Input correct user name and password, the system will enter into
initialization interface as shown in Figure 3-3. (Temporary user name and
password is Admin and admin respectively for the first time log in)

Figure 3-3 System Initialization Interface

3.4 Quality Control and Calibration

3.4.1 Quality Control

To ensure reliable results, quality control analysis must be done every day
before sample analysis. Details please refer to Chapter 5.

21
Daily Operation

3.4.2 Calibration

When the quality control is out of control, microscope calibration or results


calibration may be needed. Calibration methods please refer to chapter 6.

3.5 Sample Analysis

3.5.1 Daily Test Interface

Daily test interface is in the main menu interface, click "report" button on
the toolbar as shown in Figure 3-4.

Figure 3-4 Report Interface

3.5.2 Query and Status

Rapid Query:
For rapid query, please click the drop-down calendar on the top left corner
to choose date. The result shows on the left side list. As shown in Figure 3-5.

Figure 3-5 Rapid Query

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Senior Query:
Query conditions box pops-up by clicking on "Query" in the lower left
corner. Set query condition and click on [OK], then the results that meet
requirements display in the left side list. If the query conditions box is empty,
conditions is not added there, the condition is ‘and’. As shown in Figure 3-6.

Figure3-6 Senior Query

NOTE
When "today" is in the top left corner drop-down box, all the intraday
samples will be displayed in list. When “today” shows in the top left corner
drop-down box, all the samples of that date will be displayed in the list. When it
shows "querying”, the results of senior query will be displayed in the list. As
shown in Figure 3-7.

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Figure 3-7 Report Main List

Status: Next, New, Testing, Error, High, Tested, Checked, Sent, Printed and
Skip.
Next: Sample will be tested next.
New: New sample.
Testing: sample is testing.
Error: Sample that has not been tested due to error.
High: Sample that cannot be recognized result from high concentration.
Tested: Sample is tested but not checked.
Checked: Sample is tested and checked.
Sent: Sample is sent by HL7 protocol.
Printed: Sample is sent to printer.
Skip: Sample does not need urine sediment test.

3.5.3 Microscopy Test

Ordinary Batch Test:


Step 1: Place the test tube rack to test waiting area correctly and click "start"
on the "report" interface.
Step 2: click "start" on the toolbar, the instrument enters into test status .When
detecting the test tube rack, the analyzer will run test tube rack
movement, sample mixing and microscopy automatically.
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Step 3: the test process of sample status is Under Tested ->Testing


->Unchecked. "Unchecked" means the sample is tested and the urine
sediment result is got.
NOTE
Do not move or take out the test tube when testing in test waiting area.
Step 4: When testing, you can check counting results, input patients'
information, match urinalysis and print inspection report etc.
Emergency Test
Step 1: Place the emergency sample test tube into the emergency position,
and send it under the sample probe. When the system detects the
emergency sample test tube, the analyzer will sample it automatically.
After emergency sample, the system will automatically return to
ordinary test tube for sampling.
Step 2: The processing that is after emergency sampling is the same as
ordinary sampling processing. The following steps are completed in
turn and the results will output.
Step 3: After identification, output results of emergency sample would be
displayed on the main interface. The difference is that emergency
sample number is beginning with "9", and the "emergency" label is on
the test tube.

3.5.4 Thumbnail Browse

1) Use--Thumbnail which is the original image of analyzer camera is mainly


used for confirming large cells and selecting pictures needed to be printed.
Thumbnail is divided into two different areas, which are high power picture
and low power picture. The high power picture can be got by the 40X lens,
and the low power picture can be obtained by 10X lens.
2) Browse--In Figure 3-8, "1/84" is the serial number. The front number “1”
represents the serial number of picture selected, and "84" is the total
number of pictures. User can switch thumbnail through the left or right
arrow. Click on "4 p" or "16 p" can switch the thumbnail number. Double
click thumbnail can see the original size picture. Current thumbnails are
divided into “high power" and "low power".
3) Picture Printed Selection--We can see "Print" on thumbnail, which
means the picture can be printed on sample report. User can set selecting
default printed pictures (Refer to 4.7.2 Print Item in Chapter 4) Click any
thumbnail with mouse right button, ""Add Print" will be pop-up. Click on
""Add Print”, the picture will be printed in report. Similarly, use the same
method can cancel some image printing. If not doing the manual operation,

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the system default prints the important picture.

Figure 3-8 Thumbnail

3.5.5 Artificial classification

1) Use--Mainly used for artificial audit to make result accurate. With audit
microscopy program, the microscopy results can be corrected.
2) Interface--In Figure 3-9 "RBC" is used to indicate current item type."493"
in the box is used to show the value of current type. "Impurity" button is
used to delete pictures which are not needed."MCD" is used for showing
the current particle average diameter (The current RBC average diameter
is 8.98 microns in Figure 3-9). "Current count" indicates the number of the
thumbnails in black box (RBC with 138 thumbnails in Figure 3-10). "All
count" means total number of particles identified (There are 177 particles
in Figure 3-10).
3) Process-- Enter "classification" interface, uncertain cells can be viewed by
double-click to check the big picture. Error particles can be placed to
correct item with "classification", then Check next item with "Arrow Button".
When the last item is checked, that means artificial classification is
finished.

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Figure 3-9 Artificial classification

4) Double click particle thumbnail to view the big picture as shown in figure
3-10.

Figure 3-10 Original Picture

5) Classification
Classify to Impurity--Click "impurity" button, the button becomes orange,
then right-click considered impurity cell which would be placed into the impurity
item. During classification process, the analyzer will automatically calculate
and refresh every item result.

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Figure 3-11 Classify to Impurity

From Item A to Item B-- The items to be classified are on the left, the
target item is on the right. Click on right mouse button on thumbnail, the items
to be classified will be placed into target item and the analyzer will calculate
results automatically. In Figure 3-12 and Figure 3-13 two suspected white
blood cell particles in red blood cell are placed to "white blood cell", and these
two items have been calculated and refreshed again.

Figure 3-12 Before Classified to Calcium Oxalate Crystal

Figure 3-13 After Classified to Calcium Oxalate Crystal

6) Cancel --When the cell thumbnail background becomes silver gray, at this
time, clicking on the mouse right button can cancel this cell classification.
7) Switch Items--Using right and left button can switch to previous and next
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particle or double clicking Parameter to view them.

3.5.6 RBC Phase

1) Use--It is mainly used to provide average diameter, abnormal scale,


distribution width CV and other data of RBC. Doctors can judge the source
of the red blood cells. As shown in Figure 3-14.
2) Setting-- As shown in Figure 3-14, when print check box is selected, which
shows phase diagram will be printed.
Abnormal Scale (%) = (Abnormal RBC Quantity / RBC Total Quantity)%

x i
Average Diameter (um) = x  i 1

Distribution Width CV (%) =

Figure 3-14 RBC Phase

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3.5.7 Patient Information Input

Figure 3-15 Patient Information Input

1) Normal Operation
 Switch to the next input box-- Using keyboard TAB key or Enter key can
switch to the next input box. But the software recommends Enter key,
which can trigger some functions.
 The Drop-down Box Item Selection--use the mouse wheel or keyboard
"up”,” down" button can switch the item.
 After information input, click "save" to save patient information. Sometimes
the operator forgets to save, when he checks other sample information,
the dialog as shown in Figure 3-16 will pop up to prompt whether to save
the operation. Click "OK" to save, click "Cancel" to cancel the operation.

Figure 3-16 Save Dialog

 Diagnosis NO.-- Press Enter key, operator can check and input "Name",
"Sex", "Age", "Bed No." and "Patient type" according to diagnosis No.
 Bar Code-- Generally the bar code does not need to be input, the analyzer
can automatically access it.
 Name-- Input patient's name in "Name" box.
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Daily Operation

 Sex-- Select patient sex in the "Sex" drop-down list box. The default sex is
female, press "down" key or the mouse wheel down is "male".
 Age-- Select input mode in the "Age" drop-down list, and input patient age
before unit.
 Bed No. -- Input patient bed number in "Bed No.” box.
 Patient Type-- Select or input patient type in "Patient type" drop-down list.
To set the drop-down box items, please refer to 4.6.2. of chapter 4
 Sample Type-- Select or input sample type in "Sample type" drop-down
list. To set the drop-down box items, please refer to 4.6.2. of chapter 4
 Sender--Select or input sender in "sender" drop-down list. To set the
drop-down box items, please refer to 4.6.1. of chapter 4.
 Inspector and Checker-- User who tests is the inspector; User who
checks is the checker.
 Department-- Select or input department in "Department" drop-down list.
To set the drop-down box items, please refer to 4.6.1. of chapter 4.
 Dilution-- Dilution ratio only can be selected before test. Once selected,
analyzer will run dilution first. Operator can choose this function when the
sample is concentrated. To set default value, please refer to 4.2. of chapter
4.
 Centrifugal--This is used to show whether the sample is centrifuged. If
centrifuged, please set Yes. Then microscopy results need to be divided by
10. To set default value, please refer to 4.2. of chapter 4.
 Send Date-- Select or input send date in "send date" drop-down list.
Default value is intraday.
 Remark-- Select or input remark in "Remark" drop-down list. To set the
drop-down box items, please refer to 4.7.2. of chapter 4.

3.5.8 Urinalysis Match

Figure 3-17 Urinalysis Selection


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Urinalysis setting: please refer to 4.5.1 of Chapter 4.


When urinalysis results come, the program will automatically receive and
save. The information prompt areas in the lower right corner will prompt.
Urinalysis is displayed in the right lower corner of interface. Select the
urinalysis that matches with microscopy for manual match through the
drop-down box, then save the operation. User can also run automatically
match according to match conditions in urinalysis settings. Please refer to
4.5.1 of Chapter 4.
Urinalysis Gating: To determine whether to run urine formed element test
according to the urinalysis value. (When the urinalysis value is greater than the
critical value, the urine sediment test is needed; Otherwise, skip the
test).Please refers to 4.5.3 of Chapter 4. Bridging introduction with URIT-1600
and URIT-1600 please refers to Appendix F.

3.5.9 Print Report

Preview: as shown in figure 3-18, choose a record on the left list, then
click "preview", the simulation print effect will be shown on the right. The
"Display" corresponding drop-down box is preview mode, there are "real", "
width" and "page". "Model" is corresponding with the print model.A4_2Pic
"means this model is suitable for A4 paper and there are two pictures models.
There are four default model, add it if necessary. "Export" can turn the sample
into EXCEL document. User can quickly enter the print setup interface through
"Settings". Details please refer to 4.7 in Chapter 4.
“Print”: choose a record on the list and then click “print”. Records that you
choose will be print.
NOTE
If setting the printer failed, the “preview” and “print” cannot be clicked. You
need to do print setting in print interface Details please refer to 4.7.1 in Chapter
4.

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Figure 3-18 Preview

3.5.10 Send

Setting: Please refer to 4.8 in Chapter 4.


Method: Choose records from the left side list, then click "send" button.(The
"send" button cannot be used when it is not set )
Protocol: Please refer to Appendix E.

3.6 Shutdown

Click "shutdown" after all samples have been tested, then there will be
tooltip as shown in Figure 3-19.When operator click on "shutdown", the
analyzer will run rinse and shutdown. At this time, the system will inject
Detergent B for two channels rinse; and then prime two channels and
shutdown. When operator clicks on "Exit System", the analyzer will exit the
system.
Step 1: Remove all the test tube racks in sampling unit after all the
samples have been tested.
Step 2: Click "Shutdown", there will be a tooltip as shown in Figure
3-19.The analyzer will flush with Detergent B and rinse with Detergent A.(It
only takes 3 minutes).If choose "Exit System", the analyzer will exit the
system.

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Daily Operation

Figure 3-19 Shutdown

NOTE
Detergent B can inhibit bacteria growth, so rinse analyzer with Detergent
B after three hours.

34
Chapter 4 Maintenance and Settings

Overview: Microscope platform system setting is the basic hardware


Settings, so operator needs hardware setting permissions account to enter the
setting interface. Permissions setting please refer to 4.6.3. Click on the
“menu->test choice” and enter the parameter interface.

4.1 Maintenance

Figure 4-1 Maintenance

4.1.1 General information area

 User information: Login user, login time and user permision


 Test information: QC, test mode, precipitation and mixing switch
 Maintenance: relevant cleaning records, registration time of detergent,
Prev C using and prev B using
 Connection: serial port of urinalysis, sata send, bridging and printer

4.1.2 Common Function area

Common functions can be found here.


 Clean with Detergent C: do the cleaning when it has residual dirt in
counting chamber. Put the tubes filled with more than 3ml dertergent C in

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Settings and Maintenance

the tube rack, and put the rack onto the sample loader, then click "OK".
(See Figure 4-2)

Figure 4-2 Clean with Detergent C

 Priming Detergent A: make the piping fill with detergent as changing


Detergent A
 Priming Detergent B: make the piping fill with detergent as changing
Detergent B
 Drain: drain liquid in the piping as chaning components of flow system and
packing.
 Reagent Registration: click it to activate
 Change Password: change the current user's password
 Test Options: software setups (see Section 4.3-4.9)
 Settings: hardware setups and control (see Section 4.2)

4.1.3 Error List

The error list shows the errors and alarms yet to be processed. Please
refers to Appendix C for details. The upper portion shows the wrong SN and
time, and the lower part shows details and solutions.
 Solve: to resolve errors and alarms
 Ignore: to ignore alarms

NOTE: only warnings canbe ignored. only when there's no errors or alarms the
analyzer does test properly.
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Settings and Maintenance

4.2 Settings

Click the buttom to save settings. Click "Export" to backup setups and
click "import" to import existing settings. Motor reset and Drain before it
leaves factory, as shown in Figure 4-3.

Figure4-3 Settings

4.2.1 Video area

Observation and operation area is in the upper left of maintenance


interface. There are two videos divided, which are high power (40X objective
lens) and low power (10X objective lens).

 Shutoff: it’s the first button at the bottom of each video, which is used for
open and shut off video.
 Intensity: Set brightness parameter. The setting range is 0~250, the value
is larger, the video screen is lighter.
 Automatic brightness control: it’s used for automatic brightness
adjustment and set..
 Take picture: screenshot and keep it in JPG form.
 Legend: click on “legend”, the magnified legend which is used to
reference to adjust brightness and focal length will popup.

4.2.2 Setting area

The setting area is at the bottom right of maintenance interface.

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Settings and Maintenance

 X, Y movement speed: The movement speed range of microscope


platform is 0~255. Lower numbers equates to fast speed.
 X-axis grid step: moving one step towards X-axis is the distance that
motor travels. Greater numbers equates to long distance.
 Y-axis grid step: moving one step towards Y-axis is the distance that
motor travels. Greater numbers equates to long distance.
 CH1 focus Point: is channel 1 grid position and start point while taking
photos.
 CH2 focus Point: is channel 2 grid positions and start point while taking
photos.
 CH3 focus Point: is channel 3 grid positions and start point while taking
photos.
 Horizontal Platform: used for leveling microscope platform, please refer
to Chapter XX for details
 Focus Setting: used for setting auto-focusing, please refer to Chapter XX
for details.
 Sample Absorption Amount: used for setting sample absorption amount.
 Sample Crushes into Counting Chamber Amount: used for setting
sample crushed into counting chamber amount. The amount can be got by
sampling.
 Detergent Drain Amount: used for setting the drain amount of detergent.
 Horizontal Sampling Motor: used for setting the distance of extension
when determining the position.
 Vertical Sampling Motor: used for setting the moving down distance of
vent needle when sampling.
 Blending Setting: the “YES” and “NO” is used for setting blending before
sampling.
 Sampling Motor 1: Is at the right side of sampling station, the step setting
of pushing tube racks moving forward.
 Sampling Motor 2 Pushing: Is the distance setting of pushing tube rack
towards left side by sampling station.
 Sampling Motor 2 Back: is the return distance setting.
 Sampling Motor 3: is the step setting of pushing the tube rack out by left
sampling station.
 Bridge Step: Set bridge motor step.

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Settings and Maintenance

4.2.3 Order Operation

The order operation area is at the bottom of maintenance interface.


 Channel Thumbnail: Simulation lens are in the channel .The brighter area
is the area that lens can move, magnifying glass icon position indicates the
current lens location, cross means the icon that will move. The current
view can be removed to the cross via “setting to x,y”. As shown in Figure
4-4.

Figure4-4 Channel Thumbnail

 Location(X, Y): Display the current lens coordinates.


 Mouse (X, Y): Mouse coordinates in thumbnail.
 "Front" "Back" "Left" "Right": Make X-axis and Y-axis move to the given
direction.
 "Up" "Down": Make Z-axis move to the given direction. The figure in the
box between “Up" and "Down" button is the step Z-axis moves.
 “Move to Opt coupler”: move the microscope, making the lens locating
at 1.1.
 "Move to": Input X and Y coordinates in the "Move to” box, then click on
"Move to”, that the microscope will be placed to given coordinates.
 CH1 Point: put the microscope to the channel1 focus point.
 CH2 Point: put the microscope to the channel2 focus point.
 CH3 Point: put the microscope to the channel3 focus point.
 Sampling: sampling order.
 CH1 Sampling: Sample to Channel 1.
 CH2 Sampling: Sample to Channel 2.

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Settings and Maintenance

 CH3 Sampling: Sample to Channel 3.


 Emergency Test: click the selected Emergency Test, the operating
sampling goes to the emergency part. If not click it, the operating sampling
goes to the normal part.

4.2.4 Test Area

The test area which is in the right side of maintenance interface is


used for testing the hardware of analyzer. As per the circuit diagram and
hydraulic interconnect diagram to know the position of optocouplers,
motors and switches. Thus, it should be operated with URIT engineer’s
assistance.
 Waste Detection: used to detect waste and go back to “the waste bottle is
full or not” at prompt area at lower right corner.
 Pump Test: it is for switch motion.
 Barcode Test: used to scan barcode and display results.
 Hydraulic Optocoupler: used to go back to the hydraulic optocoupler
switch in prompt area.
 Platform Optocoupler: used to go back to the platform optocoupler switch
in prompt area.
 Microscope Optocoupler: used to go back to the microscope optocoupler
switch in prompt area.
 Hydraulic Limit Switch: used to go back to the hydraulic limit switch in
prompt area.
 Platform Limit Switch: used to go back to the platform limit switch in
prompt area.
 Microscope Limit Switch: used to go back to the microscope limit switch
in prompt area.

Microscope motor test:


 X-axis motor: used to test the x-axis motor via X motor and limit switch,
and to detect whether it is in normal.
 Y-axis motor: used to test the y-axis motor via Y motor and limit switch,
and to detect whether it is in normal.
Sampling Motor Test:

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Settings and Maintenance

 Motor 1: used to test motor 1 via the limit switch and the motor located at
right sight of sampling station, and to detect whether it is in normal.
 Motor 2: used to test motor 2 via the limit switch and the motor located at
right sight of sampling station, and to detect whether it is in normal.
 Motor 3: used to test motor 3 via the limit switch and the motor located at
right sight of sampling station, and to detect whether it is in normal.

Hydraulic Motor Test:


 Horizontal Sampling Motor: used to test the horizontal sampling motor
via horizontal sampling motor and limit switch, and to check whether it is
normal.
 Vertical Sampling Motor: used to test the vertical sampling motor via
vertical sampling motor and limit switch, and to check whether it is normal.
 Big Syringe: used to do the test by controlling the motor of double syringe
and limit switch, and to check whether it is normal.
 Small Syringe: used to do the test by controlling the motor of single
syringe and limit switch, and to check whether it is normal.

Hydraulic Solenoid Valve Test:


 V1-V16: Give instructions to 16 solenoid valves. Conclusions of solenoid
valve can be drawn through sound.

4.2.5 Horizontal Platform

Overview: It is used to adjust the microscope platform level according to


the following 5 steps.
Step 1: Mechanism returns to optocoupler automatically. The operator
place the focus liquid under the sample probe. As shown in figure 4-5

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Settings and Maintenance

Figure 4-5 Step1

Step 2: Direction selection. (X: From the beginning of the channel to the
end of the channel, Y: From channel 1 to channel 2) As shown in figure 4-6.

Figure 4-6 Step 2

Step 3: Lens moves to the corresponding position automatically. Adjust


the left video as required. As shown in Figure 4-7.

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Settings and Maintenance

Figure 4-7 Step3

Step 4: Lens moves to the corresponding position automatically (if adjust


X direction, lens will move to the end of channel 1 if adjust Y direction, lens will
move to the beginning of channel 2). Adjust well the left video. As shown in
Figure 4-8.

Figure 4-8 Step 4

Step 5: Adjust Z axis automatically. Adjust corresponding screw for video


adjustment as required. As shown in Figure 4-9.

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Settings and Maintenance

Figure 4-9 Step 5

4.2.6 Focusing Settings

Purpose: Set accurate position for automatic focusing.


Process: Run automatic focusing, and then sampling focus liquid.
Automatically correct the offset steps by clicking "Up" and "Down", then the
prompt dialog will pop up. Figure 4-10 is the interface of automatic focusing

Operation:
 "Front”,"Back”,"Left", and " Right”: Used to control horizontal platform
movement.
 "Up” and ” Down": Used to control the microscope focal length. The input
box in the middle is used to set steps for every movement.
 CH1 Point: The grids that moves to channel 1.
 CH1 Sampling: Channel 1 sampling.
 Example: Clear calibrator illustrations.
 Auto Focus: Run automatic focusing again.

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Settings and Maintenance

Figure4-10 Automatic Focusing Setting

4.3 General Settings

Overview: General settings include "Test mode", "Mic mode", "Bar code",
"RBC phrase", "Recognization", "Precipitation", "Dilution ratio", "Centrifugal",
"Mic unit", “Date format”, “ID” and "Highlight”. As shown in Figure 4-11. (It is all
about software settings from 4.3 to 4.9, which can be found and checked on
“Menu->Test”.)

Figure 4-11 General Settings

 Test Mode: There are four test modes which are Intelligent, Fast, Normal
and Fine. The difference is that the Intelligent can shoot 50 pictures at high
magnification for screening. According to screening results, the analyzer
makes judgment whether it needs to shoot more photos. If the sample
concentration is above a certain level, there are no more photos needs to

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Settings and Maintenance

be shot. If the sample concentration is moderate, another 50 photos will be


shot. If particle in sample is less, another 150 photos will be shot. 50 high
magnification photos are shot in Fast Mode, 100 photos are shot in Normal
mode, and 200 photos are shot in Fine mode. All these test modes can b
found in “Test Mode” drop-down list. The fewer pictures are, the faster
speed is, and the lower accuracy will be. The more pictures are, the lower
speed is, and the higher accuracy will be. We suggest you use the
intelligent mode which intellectualized judges shooting amounts according
to sample concentration. It not only reduces false negative but also keeps
a relative high test speed.
 Mic mode: There are two kinds of shooting modes for chosen,
respectively are 40X and 10X + 40X. It is more convenient to recognize
large cells in 10X + 40X. Select shooting mode in "Mic mode" drop-down
list. Please choose10X + 40X without special requirement.
 Bar code: Select "Yes" in "Bar code "drop-down list to apply barcode,
select "No" to not apply barcode.( Note: the application of bar code needs
an external barcode scanner, if necessary please contact with URIT sales
personnel.)
 “RBC phase”: When "RBC Phase" is on, interface label about RBC phase
appears in the "report" interface and it can be added into print report.
When "RBC phase" is” Off", there is no information about RBC phase in
the interface.
 Recognition: Set the automatic recognition time. The default is 90
seconds. Please modify it carefully.
 Precipitation: Set the automatic precipitation time. Time affects the
automatic recognition result. The default is 85 seconds. Please modify it
carefully.
 Dilution ratio: Set whether the samples run dilution. X is the pre-diluted
samples, Y is the diluted samples. “X: Y” is the default. It can be modified
under the "Under tested" or "Untested" status in patients' information input
interface.
 Centrifugal: Set whether the samples run centrifugal. This is the default. It
can be modified in patients' information input interface.
 Mic unit: There are two kinds of microscope unit, respectively are / uL and
/ HFP. Choose relevant unit, the results will be conversed and reported.
 ID Mode: “+1” means newly generated ID plus 1 on the basis of last ID.
For example, one sample ID NO. is 000005, then the newly generated ID
should be 000006. If choosing “Tube”, the new ID generates according to
the tube. For example, the first tube sample NO. is 000005, then the third
tube ID should be 000007.

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Settings and Maintenance

 Highlight: the positive sample is red when choosing “Positive”, discrete


tubes of tube rack NO. is red when choosing “Leave out”. Both above
mentioned situations occur when choosing “Positive + Leave out”.
NOTE:
Click "apply" button in the "Test options" window interface to save general
settings. Click "ok" button to save general settings and back to the interface .if
modified this page, there will be a query dialog box pop-up, as shown in Figure
4-12. When switch the next interface, if changed Settings, it also will pop up.

Figure 4-12 Query Dialog Box

4.4 Maintenance

Overview: “Initialization” is to check the analyzer status. Based on the


use conditions, choose "Clean image" and "Sleep time" reasonably to reduce
the fault rate. "Clean image” is used to delete the pictures unused."Sleep time”
is for setting the time from free to sleep state. There are “30 minutes”,” an hour”
and “never” for chonse. As shown in Figure 4-13.

Figure 4-13 Maintenance


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Settings and Maintenance

4.5 Microscopy Settings

4.5.1 Microscope Parameters

Usage: It is used for setting related contents for microscope parameters.


As shown in Figure 4-14.

Figure 4-14 Microscope Parameters

No.: There are forty parameters, which are used to display the sequence of
them.
Abbr.: Refer to the abbreviations for parameters of urine visible component.
The quantitative measurement parameters and qualitative measurement
parameters can not be modified, the rest of the parameters can be added
according to the actual test need (but the name can not be the same). They
are mainly used to establish image storage path.
NOTE
Please do not modify and add any measurement parameters optionally. If
needed, please contact with URIT after-sales service department.
 Parameter: It is used to show and print parameters.
 Type: There are color, transparency, small particles and large particles.
 Display: Whether the microscope parameters show in the report and print
interface.
Operation
Operator can choose a record in the list and then edit and modify them.

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Settings and Maintenance

and are used to adjust display and print orders. Select one record in the

list, click to move up, and click to move down.

4.5.2 Threshold

Threshold is used to judge negative and positive. The minimum class of


threshold is also taken as reference. For example, the reference of RBC is
0-10, then the reference value is 0-10. As shown in Figure 4-15.

Figure 4-15 Threshold

Semi-quantitative Value: Semi-quantitative value is shown as "+-". If it is


not selected, the results will be shown with quantitative value.
“-”, “+”, “++”, “+++”: There are four classes of valve value, namely “-”, “+”,
“++” and “+++”. Input the valve value in each class, if the result is smaller than
it and the semi-quantitative value is selected, the semi-quantitative value of
this class will be displayed.
Operation: Edit the value and select semi-quantitative value in the list
then save.

4.5.3 Sample Volume

The length, width and height displays as show in Figure 4-16.Sample


volume for every counting can be calculated through these three parameters
and pictures collected, so as to get the number of unit volume cells.

49
Settings and Maintenance

Figure 4-16 Sample Volume

Default setting:
High power length of horizontal direction--0.17mm
High power length of vertical direction--0.11mm
Low power length of horizontal direction--0.68mm
Low power length of vertical direction—0.44mm
CH1 thickness--0.15mm
CH2 thickness--0.15mm
CH3 thickness--0.15mm

4.5.4 Urinalysis Settings

The purpose is to receive other instruments urinalysis results. As shown in


Figure 4-17.

Figure 4-17 Urinalysis Settings

50
Settings and Maintenance

 Auto connection on boot: Analyzer opens the serial port according to the
current settings after selected.
 Auto match: Analyzer will match corresponding urinalysis according to
the condition after microscope when selected.
 Auto adds a new: Analyzer will match with microscopy results after
receiving urinalysis as selected. If not matched together, it goes match with
the under test and untested microscopy. As all samples that match with
corresponding urinalysis, a new sample will add and go match with
microscopy.
 Auto match conditions: the auto match conditions are in the top right
corner. Three modes can be selected there, which are "Tube", "ID" and
"Barcode". The choices can be multiple. High priority will be first judged
when multiple-choice. If matching is not successful, low priority will be
taken into account. Priority can be adjusted by clicking the "up" and "down"
arrow buttons.
 Model: Choose corresponding models for different models data analysis.
(Contact URIT customer service if there is no choice). When selected,
Baud rate, Parity, Data bits, Stop bits and Delay will be set to default.
 Bridging: Only URIT-1500 and URIT-1600 uses this mode.
 Prompt: Only with URIT-1500 and URIT-1600 can be used. URIT-1500
and URIT-1600 will send corresponding Settings when opening. Prompts
on whether to synchronize with corresponding settings will pop up.
 Port No.: There is COM1 at the back of URIT-1280. COM1 is selected by
default.
 Baud rate: Choose the baud rate for urinalysis analyzer connection in
"Baud rate" drop-down list.
 Data bit: Choose the data bit for urinalysis analyzer connection in "Data
bit" drop-down list.
 Parity: Choose the parity for urinalysis analyzer connection in "Parity"
drop-down list.
 Stop bit: Choose the stop bit for urinalysis analyzer connection in "Stop
bit" drop-down list.
 On: click "On" button, the analyzer will open the corresponding port
according to settings, and the connection information will be displayed in
the system status bar.
 Off: click "Off" button, the analyzer will disconnect the port, and the
disconnection information will be displayed in the system status bar.

NOTE
If this urine sediment analyzer can not receive the data from urinalysis
analyzer, please contact with URIT after-sale service department.
The analyzer can only receive parts manufacturers' urinalysis analyzer
data. If need to add new urinalysis analyzer support, please contact with URIT
after-sale service department.

51
Settings and Maintenance

4.5.5 Urinalysis parameter

The interface of urinalysis parameters settings is shown in Figure 4-18,


which is used to display and print urinalysis parameters.

Figure 4-18 Urinalysis Parameters

 No.: Refer to the sequence of print and display.


 Abbr.: Set the abbreviation the same as those of urinalysis analyzer.
 Parameter: It is for display and print.
 Reference: It is for display and print.
 Display: The parameters selected can be shown in report and print
interface.

Operation

Operator can edit and choose related information in the list. Click and

to adjust the display and print sequence of parameters, then click OK or


Apply for save.

4.5.6 Urinalysis Gating

Purpose: Choose skip the urine sediment test or not according to


urinalysis results. As shown in Figure 4-19.

52
Settings and Maintenance

Figure 4-19 Urinalysis Gating

Test All: No urinalysis result is judged. All samples need to be tested.


By conditions: If urinalysis result is more than the threshold, the sample
needs urine sediment test. Select the parameters for test conditions. As shown
in Figure 4-20, urinary sediment test will be taken when urinalysis BLD red
blood cell value is equal or greater than 1, but not vice versa. There’s no need
to determine the critical value as no match urinalysis. Test will do directly.

 Microscopy Query: the Asking box pops up after selecting “Microscopy”.


The test will do as click”OK”, otherwise, please click “Cancel”. One blank
microscopy results generates.

Figure 4-20 Test Conditions

53
Settings and Maintenance

4.6 Dictionary maintenance

4.6.1 Send Information

Overview: It is for setting the department and sender. Operator can select
the items needed by the drop-down list after setup or input the code then press
Enter for display, which can improve the efficiency of information input. As
shown in Figure 4-21.

Figure 4-21 Send Information

Operator can modify the information directly in the list, add the content in
the last line, or click mouse right button for delete.

4.6.2 Sample and Patient Type

Overview: It is for setting the sample type and patient type. Operator can
select the items needed by the drop-down list after setup or input the code
then press Enter for display, which can improve the efficiency of information
input. As shown in Figure 4-22.

Figure 4-22 Sample and Patient Type


54
Settings and Maintenance

Operator can modify the information directly in the list, add the content in
the last line, or click mouse right button for delete.

4.6.3 User Registration

Overview: The operator who owns user administration permission can use
this function. It can establish new user and modify user permission. The
password of new user is default null. As shown in Figure 4-23.

Figure 4-23 User Registration

System settings: The user can enter 4.1 of Chapter 4 for microscope
platform setting with this permission.
Users manage: The user can run user registration and enter 7.1 of
Chapter 7 for statistics.
Operator can modify the information directly in the list, add the content in
the last line, and click mouse right button for delete.

4.7 Print Setting

4.7.1 Page

Print the inspection report after selecting the application format. Operator
can set Printer, Paper Size, Orientation and Margin. As shown in Figure 4-24,
all print Settings of the software are in this interface, including report print,
calibration print and control print.

55
Settings and Maintenance

Figure 4-24 Print page

Printer: Select the printer connected with the analyzer in the drop-down list.
Paper Size: Select the paper size in the drop-down list. A4, A5 and B5 are
available.
Orientation: There are horizontal and vertical available.
Margin: Top margin and left margin can be set

4.7.2 Print Parameters

Overview: Set some default options, as shown in Figure 4-25.

Figure 4-25 Print parameters

 Hospital: The tile of the report.


 Remark: Generate the words of new samples.
 Selected images: the pictures before new samples generation.
 Print phase: Select whether to print RBC phase when new sample results
are generated.
NOTE: the default note, selected image and print phase automatic generates
56
Settings and Maintenance

when a new sample generating. Users can modify it when necessary.

4.8 Send

Overview: There are two communication methods available, respectively


are "Send by COM port" and "Send by network port". As shown in Figure 4-26.

Figure 4-26 Data Send

 Send by COM Port: Select it for sending by COM port.


 Port No.: Select the port No. in the drop-down list. (Note: this port No.
should not be the same as that of urinalysis, or the result cannot be sent.)
 Baud rate: Select the baud rate in the drop-down list.
 Send by network port: Select it for Sending by network port.
 IP: Input the IP in the box.
 Port: Input port No. in the box.
 Mode: Send after disconnect and connect all the time
 Send image: send the images by network port when select it.

4.9 Control Setting

As shown in figure 4-27, the tab order is the position corresponding tube
rack (L1 is the first position). The line in blue color is the currently using QC.
The reference and deviation value of WBC and RBC, expired date and remark
can be set in this interface. target value and 1SD of quality material is the
reference value. Confirm QC results via setting target value and out of control
conditions. only finishing QCsettings can make QC test in relevant interface.
( Please note that QC setting is needed when changing the control material.
When the control material is out of expired time, the word is shown in red and
the QC test can not run. At this time, we only can browse the previous results)
57
Settings and Maintenance

The following operations can be done:


1. The QC information can be modified directly in the list.
2. Add new content in the last line of the list.
3. Right clcik to delete the chosen content.

Figure 4-27 Control Setting

58
Chapter 5 Quality Control

5.1 Overview

To understand the status of the analyzer, it is recommended to run quality


control before test everyday. If the result is within the control, which means the
analyzer is normal; if not, the operator can calibrate it via microscope. (Please
refer to Chapter 6)

5.2 QC Interface

As shown in Figure 5-1

Figure 5-1 QC Interface

 "Lot No.", "All" and "Month": These query conditions are on the top left
corner. User can choose the query conditions from the drop-down list.
 Results list: There are 30 results shown on the left list. The L-J QC
diagram, mean, SD and CV etc. will be shown on the right. The results
printed are those on the interface. Operator can switch to other 30 results
with seek bar.
 QC Information: To choose the result of WBC or RBC.
 L-J QC Diagram: This is the diagram of 30 results.
 Mean: It is calculated from the results on the left.(Please refer to 5.4)

59
Quality Control

 SD: It is calculated from the results on the left.(Please refer to 5.4)


 CV: It is calculated from the results on the left.(Please refer to 5.4)
NOTE
L-J diagram, mean, SD and CV are calculated from the left results, when
the results change, they change also.

5.3 QC setting

Please refer to 4.9 of chapter 4.

5.4 Calculation method

Mean ( x )
x i
x i 1

Standard
SD 
 (x i  x) 2
Deviation(SD) n 1

Coefficient of SD
CV   100%
Variation(CV) x

5.5 QC Test

Put the control in the sampling station like Figure 5-3 and click "Start", the
following query box pops-up. As shown in Figure 5-2.

Figure 5-2 QC Test

60
Q
Quality Contrrol

Figure 5-3
3 Today QC

5.6
6 QC Prrint

The resuults on the interface will


w be prin
nted. The print
p previe
ew interfac
ce is
sho
own in Figu
ure 5-4.

Figure
e 5-4 Print Preview
P

61
Chapter 6 Calibration

6.1 Overview

This chapter is mainly about microscope focus calibration and results


calibration, which is to make results more accurate.

6.2 Interface and Operation

The top left corner is video area, lower right corner is about calibration
parameters correction area, and the microscope focus calibration area is on
the right bottom. As shown in Figure 6-1.

Figure 6-1 Calibration Interface

 Thumbnails: real-time simulate the lens position in the channel, the lens
can move in the brighter areas, a magnifying glass icon indicates the
current lens area, cross icon indicates the position moved to.
 Rack in: The test tube moves to probe below.
 CH1 Sampling: aspirate sample to channel 1.
 CH2 Sampling: aspirate sample to channel 2.
 CH3 Sampling: aspirate sample to channel 3.
 CH1 Rinse: Rinse channel 1.
62
Calibration

 CH2 Rinse: Rinse channel 2.


 CH3 Rinse: Rinse channel 3.
 Flush: Flush operation.
 CH1 Point: Click “CH1 Focus” button, making the microscope move to the
channel 1 focus position.
 CH2 Point: Click “CH2 Focus” button, making the microscope move to the
channel 2 focus position.
 Move to (X, Y): Input X and Y coordinate in the boxes, and click this button
to move the microscope to the right place.
 Front, Back, Left and Right: Make the microscope X axis and Y axis
move towards corresponding direction.
 Auto Focus: Run Prime and move to CH1 point, and then choose the best
focus position.
 Up Down: Make the microscope Z axis to the corresponding direction.
Moving steps relates to the type-in value in the input box.

6.3 Microscope Calibration

 Manual Focusing: Through the operation button to manually perform the


following process. (Aspirate focusing fluid, move to the right place, and
press "up" and "down" to adjust the focal length)
 Auto focus: Click Auto Focus to perform this operation.

6.4 Calibrator Calibration

6.4.1 Use

If the test result is partial smaller or larger than the actual value, please
calibrate it via calibrator.

6.4.2 Method

Put the calibrator into the sample loader (5 test tubes into a test tube rack),
then click “Start”, the dialog box as shown in Figure 6-2 will pop up.

63
Calibration

Figure6-2 Calibration Query

The result will be saved in Test value1-test value5. Input calibrator


reference to calculate the calibration coefficient. calibration coefficient=
Reference/Mean x 100% (When the result is less than 70%, coefficient is
taken as 70%, when the result is more than 130%, coefficient is taken as
130%). After calculation, the calibration coefficient can be saved and used.
(Input lot No. and press save button to use the current calibration coefficient as
shown in Figure 6-3) .Calibration history is shown in Figure 6-4.

Figure 6-3 Test Results Figure 6-4 Calibration History

 Use: Click Use, the calibration coefficient in history can be used. (Blue
background is the calibration coefficient used, orange background is the
present calibration coefficient selected.)
 Delete: press “Delete” to delete history calibration record. If delete the
using record, 100% default record will be selected.
 Preview: Preview the history calibration record. See Figure 6-5 for
reference.
 Print: Print the history calibration record. (see 4.7.1 of Chapter 4 for
details)

64
Calibration

Figure 6-5 Calibra


ation Print

65
Chapter 7 Others

7.1 Statistics

Workload statistics: Workload statistics of a certain historical period, as


shown in Figure 7-1.

Figure 7-1 Workload

 Time Period: The historical data can be statistics over time period.
 Department: Statistics according to the clinical departments on inspection
application form.
 Doctor: Statistics according to the urine sample amount used on this
instrument by the doctors.

7.2 Data Recovery

The instrument operating speed may become slow when accumulating a


mass of patient data. Therefore, our company provides you with the data
backup and restores function.

66
Others

Data transfer is divided into two kinds: one kind is to backup the patient’s
microscopy data which temporarily are not used to the backup table. The other
is to return the patient microscopy data in backup table to the system.
 Data Backup

Figure 7-2 Data Transfer

The instrument performance may decline after it has run for a certain time
(More than two years). User can run this program to transfer the overdue data
to the backup table so as to improve the current table query speed. Operation:
Choose "Backup/ Recovery" first, select "Data backup", and then choose the
backup directory, and click "OK" finally.

 Data Recovery
When the data is destroyed, choose "Data recovery"; select the database
backup in the system directory to import the data to the system.
 Data Export
Export the sample data to the EXCEL file.

67
Chapter 8 Troubleshooting

This Chapter gives instructions for identifying, troubleshooting, and


correction of analyzer problems. If malfunction are not solved according to
guidance or more information is needed, please contact URIT Customer
Support Centre.

8.1 Troubleshooting Guidance

The Troubleshooting Guidance is designed to assist the operator in


identifying and resolving analyzer problems. Instructions are also given for
obtaining technical assistance immediately from URIT Customer Support
Centre. The first step in the process is to understand normal analyzer
operation and preventive maintenance. Experience helps for identifying and
resolving operational problems. Logical troubleshooting may be divided into
three steps:
1. Problem Identification
2. Fault Classification
3. Trouble Removal
Step 1: Problem Identification means not only identifying what is wrong but
also what is right.
Step 2: Analyzer problems are generally divided into three categories:
1. Hardware component related
2. Software computer programs related
3. Measurement related to sample analysis
Hardware and software problems can only be corrected by a URIT
authorized engineer. The operator can correct sample measurement problems
with assistance from URIT engineers.
Step 3: Corrective Action means taking appropriate action to correct the
problem. If the operator can correct the problem, with or without technical
assistance from manufacture, normal operation can quickly resume.

8.2 Obtaining Technical Assistance

Technical Assistance is obtained by calling the URIT Customer Support


Centre. When assistance is needed, please provide the following information
for Customer Support Specialists:

68
Troubleshooting

1. The analyzer model


2. Serial number and version number
3. Description of the problem and surroundings, including status and operation
4. The lot numbers of the reagents (detergent A, detergent B and dye)
5. Data and report of the problem
Common problems and disposals are given in this Chapter. The operator
can identify the cause and deal with problems according to the warning
information and Troubleshooting Guide.

8.3 Troubleshooting

Familiar problems and corrective actions are listed as follows. If the


problems cannot be corrected, or technical assistance is needed, please
contact with URIT Customer Support Centre.

8.3.1 Startup Error

Probable Cause:
① Analyzer power receptacle damaged;
② the fuse in the rear panel melted.
Corrective Action:
① Replace the analyzer power receptacle.
② Replace the fuse on the rear panel.

8.3.2 Not display

Probable Cause:
The signal cable of TFT Monitor was loose.
Corrective Action:
Reconnect the signal cable of TFT Monitor well and fasten the screws.

8.3.3 Mouse Error

Probable Cause:
① the cable of mouse was loose;
② the mouse was broken.
69
Troubleshooting

Corrective Action:
① Reconnect the cable well.
② Replace the mouse.

8.3.4 Keyboard Error

Probable Cause:
① The keyboard cable was loose;
② The keyboard was broken.
Corrective Action:
① Reconnect the keyboard cable well.
② Replace the keyboard.

8.3.5 Printer error

Probable Cause:
① the printer cable was loose;
② Connection errors between the cable and power receptacle;
③ the power of printer is turn off.
Corrective Action:
① Reconnect the cable of printer well;
② Reconnect the cable with the power receptacle well;
③ Turn on the power of printer.

8.3.6 No Rinse

Probable Cause:
The detergent used up.
Corrective Action:
① Replacing detergent.
② Pressing “Rinse” in the operation menu to make the tube full of detergent.
③ In the menu of basic maintenance, check the detergent A and detergent B.

70
Troubleshooting

8.3.7 Waste full

Probable Cause:
① Waste is full;
② Waste senor cable was loose.
Corrective Action:
① Empty the waster container;
② Reconnect the waste senor cable well.

71
Chapter 9 Precautions, Limitations and Hazards

Improper operation will not accomplish optimal performance; even cause


damage to the operator or others. To avoid the damage and get a successful
measurement, a criterion should be designed to perfect the service conditions.

9.1 Limitations

a) The analyzer is designed for in vitro diagnostic use.


b) Any operation, shipment, installation or maintenance must strictly follow the
contents outlined in this manual, or if any problems derived from that, URIT will
not offer free warranty.
c) URIT has designed the analyzer system components for optimal
performance. Substitution for reagents, controls and calibrators and
components recommended by other companies may adversely affect the
performance of the analyzer or cause incidents, thus lose the free warranty.
d) Any repairing must be permitted and any accessory replacement must be
specified by URIT, if any problems derived from that, URIT will not offer free
warranty.
e) Follow the recommended maintenance schedules and procedures. Any
incompliance will shorten the life span and affect the test results, or cause
incidents, thus lose the free warranty.

9.2 Installation Limitations

a) A URIT authorized Engineer must perform the initial installation.


b) Place the analyzer on a stable, level surface. Locate the system
- Away from direct sunlight,
- Away from path of a cooled or heated air outlet with temperature extremes
- Away from drying ovens, centrifuges, x-ray equipment, copiers or ultrasonic
cleaner.
c) Place the reagent containers on the same level as the analyzer.
d) Adequate space should be provided around the analyzer. Keep at least
40cm away from the surrounding objects for proper ventilation, and 3 square
meters space is needed for the analyzer.

72
Precautions, Limitations and Hazards

f) Before operating the analyzer for the initial measurement, verify that each
reagent tuning is connected to the appropriate inlet and reagent container.
Make sure the outlet tubing is not twisted and the waste tubing is connected to
the appropriate outlet and routed to a suitable waste container or drain.
g) Do not disconnect any electrical connection while the power is ON. Verify
the analyzer is well connected with the ground to prevent electrical interfere
and ensure the safety.

CAUTION

Anyone without authorization of URIT should NOT remove the screws on the
cover, or the customer must take all the responsibility.

9.3 Personnel Protection and Infection Control

a) Follow required laboratory or clinical procedures during daily operation or


maintenance. Wear gloves, lab clothing and safety glasses to avoid direct
contact to the samples.
b) Consider all the clinical specimens, controls and calibrators etc, that contain
human blood or serum as being potentially infectious, wear standard
laboratory clothing, gloves and safety glasses and follow required laboratory or
clinical procedures when handling these materials. Do not smoke, eat or drink
at working area. Do not suck or blow the tubing.
c) Consider the blood samples and waste have potential source of biological
and chemical hazard, the operator should handle with extreme care during the
disposal process and follow regulations of the local government when cleaning,
handling, discharging.
d) Follow the manual to keep reagent from deterioration, misapplication or
eating by mistake. The reagent should be away from temperature extremes.

CAUTION

 Reagent will freeze when it is below 0℃, for which the reagent cannot be
used.
 Keep the reagents away from direct sunlight to avoid evaporation and
contamination. Seal the cap of the container. Minimize the diameter of the
hole to avoid evaporation and contamination.
 Operated in accordance with provisions of this Specification, otherwise, all
problems shall be borne by customer.

73
Appendix A: Instrument Icon and Symbols

Specification

Caution Biohazard

In Vitro
Shock hazard Diagnostic
Medical Devices

Protect from heat


and radioactive Serial number
sources

Environment
Protection Use Equipotential
Period

Protective
Waste recycling
Conductor Terminal

74
Appendix B: Instrument Specifications

Dimensions and Weight Environmental Requirements


Dimension: L650× W640× H560mm Temperature 5℃~40℃
Weight: 50Kg Relative Humidity: ≤85%RH
Barometric: 75kPa~106kPa

Transport and Storage Specifications Power Specifications


Temperature: -20℃~55℃ Power Supply: AC 100V ~240V
Relative Humidity:≤93%RH Frequency: 50/60Hz
Barometric: 86kPa~106kPa Fuse: T3.15A L250V
Power: 150~220VA

Intended Use
The Analyzer applies to the qualitative and quantitative analysis of the urine sediment.
Appearance Specifications
Display: 22-inch LCD
Language: English/Simplified Chinese
Parameters
Abbreviation Full Name
RBC red blood cell
WBC white blood cell
SQEP squamous epithelial cells
NSE Non-squamous epithelial cells
HYA Cast
GRAN Hyaline Cast
CAOX Calcium oxalate crystal
URIC Uric acid crystal
BACT Bacteria
YST Yeast
MUCS Mucus

Ports
(1)DVI-D video port (2)internet port 1 (3)internet port 2
(4)USB 1 (5)USB 2 (6)USB 3
(7)USB 4 (8)COM

Sample / Reagent Consumption


Urine Sediment: 1.2 ml
Detergent A: 7.5mL/ times
Detergent B: 15 ml/ time
Note: Reagent consumption is various according to the software version.

75
Appendix C: Trouble List

No. Trouble Description


TROUBLE 1 Serial port is not open COM2 abnormal

TROUBLE 2 Comms timeout Comms timeout

TROUBLE 3 A1 Control panel comms abnormal A1 Control panel broken or comms abnormal

TROUBLE 4 A2 Control panel comms abnormal A2 Control panel broken or comms abnormal

TROUBLE 5 Video not started Camera not started

TROUBLE 6 Low intensity LED light broken or LED drive circuit broken

TROUBLE 7 High intensity Exception set or LED drive circuit broken

Tube rack is full, or tube position can not be test


TROUBLE 8 Sampling error
properly.

TROUBLE 9 barcode error Wrong pasting place or bar code editor broken.

TROUBLE 10 Detergent unregistered Detergent password aging

TROUBLE 11 No detergent

TROUBLE 12 Waste full

76
Appendix D: Parts List for Replacement

N0. Name Remark


1 Power Supply
2 Fuse
3 LCD
4 Mouse
5 Keyboard
6 Microscope Focusing Mechanism
7 Lens
8 Microscope Table Including motor
9 Digits Camera
10 Three-way Solenoid Valve
11 Two-way Solenoid Valve
12 Syringe
13 Vacuum Pump
14 Plastic Tube
15 Silicone Tube
16 Rotary Step Motor
17 Linear Step Motor For the syringe
18 Sampling Unit Including motor
19 Sample Loader Including motor
20 Computer Microprocessor
21 A1 Control Board
22 A2 Control Board
23 Liquid Detection Circuit Board
24 Solenoid Valve Drive Circuit Board
25 Key-press Circuit Board
26 Optocoupler RG131 Circuit Board Including connection cable
27 Optocoupler RG145 Circuit Board Including connection cable
28 Barcode Scanner

NOTE:
Please use specified parts for maintenance and replacement, which is
performed by the personnel authorized by URIT. We do not undertake any
responsibility for all the consequences caused by using or replacing any
devices not recognized by URIT.

77
Appendix E: HL7 Protocol for URIT-1280

E.1 Communication Protocol


E.1.1 Communication Mode
The HL7 protocol of URIT Urine Sediment Analyzer is created according to the HL7

v2.3.1 standards.。

<SB>information<EB><CR>

SB Start Block Character 1 byte ASCII<VT> 0x0B

EB End Block Character 1byte ASCII<FS> 0x1C

CR Carriage Return 1byte ASCII <CR> 0x0D


E.1.2 Response
HL7 regulates that data receiving party must return a confirmation message to data
provider for any news. It is suggested all the analyzers use 0x06 and don't pass back data
so as to improve the compatibility.

E.2 Information Grammar


E.2.1 Delimiter
| Fields Delimiter

^ Component Delimiter

& Subcomponent Delimiter

~ Repeat Delimiter

\ Escape Character
E.2.2 Identifier Meaning
Identifier Hexadecimal Code ASCII Code Meaning
<SB> 0x0Bh <VT> Data Head
<EB> 0x1Ch <FS> Data Tail
<CR> 0x0Dh <CR> New line

E.2.3 Message Type


The communication between analyzer and lis adopts QRU. That is Unsolicited

Observation Reporting.

The news regulation: instrument actively transmits the data to the lis.
ORU includes the following contents:
- Patient Data: Name, sex and sample No. etc.
- Doctor's advice: Sample type, sender, inspection doctor, clinical diagnosis and remark
etc.
78
- Result: Parameter test results and related multimedia data, such as diagram etc.
E.2.4 Message structure
E.2.4.1 Overall structure
MSH Message head
{
[PID] Patient data
{
OBR Observation report
[OBX] Test result
}
}
E.2.4.2 Urine Sediment Analyzer Structure
<SB>

MSH|^~\&|[CompanyName]|[InstrName]|LIS|PC|[ResultTime]||ORU^R01|[InstrType]|P|2.3

.1||||||UNICODE<CR>

PID|[PatType]|[PatID]|[PatBarCode]| [PatBedCode]|[PatName]|| [PatBirth]| [PatSex]<CR>

OBR|[SampleType]|[REQID]|[SampleID]|[CompanyName]^[InstrName]||[SampleTime]|[St

artTime]||||||[Symptom]||[SanpleType]|[SendDOCName]|| [SendDP]<CR>

OBX|1|[ValueType]|[ItemID]|[ItemName]|[TestResult]|[Unit]|[ConsultValue]|[Flag]|||F||[OD]|

[ItemResultTime]|[DocDP]|[DOCName]|[Method]<CR>

OBX|1|ED|[ ItemID]|[ItemName]|[InstrID]^Image^[FormartName]^Base64^Qk02XgEAAAA

AAAAAAAAAAAAAAAAAAAAAAAAAAAA…||||||F|||[ ItemResultTime]|[ DocDP]|[ DOCNa

me]|

<EB><CR>

{Repeat OBX, send several parameters test results of a sample once}, Please pay more

attention to the OBX format of image data. For JPEG format data, use base64 for code

conversion.
E.2.4.3 Message Head Meaning
MSH|^~\&|[CompanyName]|[InstrName]|LIS|PC|[ResultTime]||ORU^R01|[InstrType]|P|2.3

.1||||||UNICODE
Identifier Meaning Format
[CompanyName Company Name ASCII Character String
]
[InstrName] Instrument Name ASCII Character String
[ResultTime] Result Sent Time yyyyMMddhhmmss
[InstrType] Instrument Type ASCII Character String
79
For example:

MSH|^~\&|URIT|UT-1280|LIS|PC|20101010093505||ORU^R01|URIT-USA|P|2.3.1||||||UNI

CODE
E.2.4.4 Patient Data Meaning:
PID|[PatType]|[PatID]|[PatBarCode]| [PatBedCode]|[PatName]|| [PatBirth]| [PatSex]<CR>
Identifier Meaning Format
[PatID] Patient ID.(Optional) ASCII Character String
[PatType] Patient Type 1 byte ASCII Character String 1Normal
2 Emergency
[PatName] Patient Name (Optional) Unicode Character String
[PatBarCode] Barcode (Optional) ASCII Character String
[PatBedCode] Bed code(Optional) ASCII Character String
[PatBirth] Patient Birth(Optional) yyyyMMdd
[PatSex] Patient Sex(Optional) 1byte ASCII Character String M mail
F female
For Example: PID|1|1010051|A1123145|15|Zhangsan||19811011|M
E.2.4.5 Doctor Advice Meaning
OBR|[SampleType]|[REQID]|[SampleID]|[CompanyName]^[InstrName]||[SampleTime]|[St

artTime]||||||[Symptom]||[SanpleType]|[SendDOCName]|| [SendDP]<CR>
Identifier Meaning Format
[SampleType] Sample Type(Optional) 1 byte ASCII Character String 1Normal
2 Control 3 Calibration
[REQID] Request ID(Optional) ASCII Character String
[SampleID] Sample ID ASCII Character String
[CompanyName] Company Name ASCII Character String
[InstrName] Instrument Name ASCII Character String
[SampleTime] Send Time(Optional) yyyyMMddhhmmss
[StartTime] Start Test Time(Optional) yyyyMMddhhmmss
[Symptom] Symptom(Optional) Unicode Character String
[SampleType] Sample Type(Optional) 1 byte ASCII Character String 1Normal
2 Control 3 Calibration
[SendDOCName] Send Doctor(Optional) Unicode Character String
[SendDP] Send department ID ASCII Character String
(Optional)
For Example:

OBR|1|101009001|000001|URIT^UT-1280||20101010093000|20101010093500||||||Blo

od Urine||URI|Lisi||011

80
E.2.4.6 OBX File of Common Item Meaning
OBX|1|[ValueType]|[ItemID]|[ItemName]|[TestResult]|[Unit]|[ConsultValue]|[Flag]|||F||[OD]|

[ItemResultTime]|[DocDP]|[DOCName]|[Method]<CR>
Identifier Meaning Format
[ValueType] Value Type NM is number,ST indicates text ED
means others.
[ItemID] Item ID ASCII Character String
[ItemName] Item Name(Optional) Unicode Character String
[TestResult] Test Result SCII Character String
[Unit] Unit ASCII Character String
[ConsultValue] Reference SCII Character String
[Flag] Abnormal Result Flay 1byte H is high N is normal L is low
[OD] Original Result(Optional) ASCII Character String
[ItemResultTime] Item Result Send Time yyyyMMddhhmmss
(Optional)
[DocDP] Inspection Doctor Department
ID(Optional)
[DOCName] Doctor’s Name(Optional)
[Method] Test Method(Optional) ASCII Character String
ForExample:OBX|1|NM|001^WBC|WBC|0.4|ul|0.0-1.0|N|||F|||20101010094505|011|Wang

wu|
E.2.4.7 OBX Image Field Meaning
OBX|1|ED|[ItemID]|[ItemName]|[InstrID]^Image^[FormartName]^Base64^Qk02XgEAAAA

AAAAAAAAAAAAAAAAAAAAAAAAAAAA…||||||F|||[ ItemResultTime]|[ DocDP]|[ DOCNa

me]|
Identifier Meaning Format
[ItemID] Item ID ASCII Character String
[ItemName] Item Name(Optional) Unicode Character String
[InstrID] Remark ID ASCII Character String
[FormartName] Image Type ASCII Character String
[ItemResultTime] (Optional) yyyyMMddhhmmss
[DocDP] Item Result Send Time
(Optional)
[DOCName] Doctor’s Name(Optional)
For Example:

OBX|1|ED|IMG1|3|UT1280^Image^JPEG^Base64^Qk02XgEAAAAAAAAAAAAAAAAAAA

AAAAAAAAAAAAA||||||F|||20101010093515|011|Wangwu|
E.3 Integrated Example
E.3.1 Example
81
<SB>

MSH|^~\&|URIT|UT-1280|LIS|PC|20101010093505||ORU^R01|URIT-USA|P|2.3.1||||||UNI

CODE

PID|2|1010051|A1123145|15|zhangsan||19811011|M<CR>

OBR|1|101009001|000001|URIT^UT-1280||20101010093000|20101010093500||||||RBC

urine ||URI|Li||011<CR>

OBX|1|NM|001^WBC|wbc|0.4|ul|0.0-1.0|N|||F|||20101010094505|011|Wangwu|<CR>

OBX|1|NM|002^RBC|rbc|0.2|ul|0.0-1.0|N|||F|||20101010094505|011|Wangwu|<CR>

OBX|1|ED|IMG1|Image1|UT1280^Image^JPEG^Base64^Qk02XgEAAAAAAAAAAAAAA

AAAAAAAAAAAAAAAAAA||||||F|||20101010093515|011|Wangwu|<CR>

<EB>

<CR>
E.3.2 Nature Language
【Data Head】

transmission time: At 9:03:05 on Oct. 10th, 2010

Format: ORU R01

Data Type: Biochemical Data

Version: HL7.2.3.1

Code: UNICODE

【Patient 】

Patient ID: 1010051

Barcode: A1123145

Bed No.:15

Name: Zhang San

Date of Birth: Oct.11th, 1981

Gender: Male

【Doctor Advice】

Request No.: 101009001

Sample No.: 000001

Inspection Instrument: URIT-1280

82
Send Time: At 9:30am on Oct.10th, 2010

Inspection Time: At 9:35am on Oct.10th, 2010

Symptom: Blood Urine

Doctor: Li Si

Depatment: 011

【Result】

WBC: 0.4μL

Reference Value: 0.0-1.0

Report Time: At 9:45:05am on Oct. 10th, 2010

Doctor ID.: 011

Name: Wang Wu

RBC: 0.2μL

Reference Value: 0.0-1.0

Report Time: At 9:45:05am on Oct. 10th, 2010

Doctor No.: 011

Name: Wang Wu

【Result Image】

Name: Image1

Format: JPEG, the format is converted into

Qk02XgEAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA

Report Time: At 9:35:15(am) on Oct.10th, 2010

Doctor ID: 011

Name: Wang Wu

83
Appendix F: Bridging and Communication
F.1 Hardware Requirements

Cross-structure offered by URIT is needed.

F.2 Online Protocol with URIT-1600

F.2.1 order

Machine Order Meaning

URIT-1600 02 0D 0A 73 74 61 72 74 0D 0A 03 Query Start

URIT-1280 FE FE 82 A0 82 01 A5 16 Enter

URIT-1600 02 0D 0A 65 6E 64 0D 0A 03 Tube on the bridge end

URIT-1280 FE FE 82 A0 82 02 A6 16 Tube in the URIT-1280 sampling


station

URIT-1600 Sending URIT-1600 setting


message

URIT-1280 Others is taken as data Data format is wrong. Prompt


message of “receive error”
popup.

F.2.2 Data

ID: when URT-1600 selects tubes, the ID NO. is composed of 6 digits, first 4 is the
tube rack NO., and the last 2 digits is the tube NO.. When selecting barcode, the ID NO. is
the barcode NO..

Item: there’s no less than one blank space between item name and value.

F.2.3 Procedure

URIT-1600: enter enquiry (“Start”) continuous issues till getting response from the
analyzer. The “End” is continuous issuing as tube rack is pushing onto the bridge. The
next enquiry comes up until the analyzer gives message on tube in sampling station.

The Analyzer: quickly response as receiving enter enquiry (“Start”). Analyzer stops to
send tube rack onto bridge when receiving the “End” order, then giving a response to
1600 after sending tube in sampling station.

84
F.3 Online Protocol with URIT-1600

F.3.1 Bridging

1600: enter bridge


or not

1600: receive
response

1280: quickly
NO response

YSE

1600: receive response

1600: finish entering

1280: receive response

a) URIT-1600: asking for entering bridge (02 0D 0A 73 74 61 72 74 0D 0A 03) --- if not


receiving response from analyzer in a certain period f time, enquiry will be sent again
later.

b) Analyzer: quickly response “YES” (02 4F 4B 20 20 03) or “NO” (02 57 41 49 54 03) ---
if receiving “NO”, URIT-1600 waits and repeats the above actions again. Enquiry
timeout sends if URIT-1600 has no response in a certain period of time.

c) URIT-1600: quickly response “Receiving Order” (02 0D 0A 67 65 74 20 0D 0A 03).

d) URIT-1600: finish entering (02 0D 0A 65 6E 64 0D 0A 03) --- if not receiving response


from analyzer, order will be sent later.

e) Analyzer: quickly response “Receiving Order” (02 67 65 74 20 03)

85
F.3.2 Results Transmission

START

a) Sending URIT-1600
setting information

b) Sending results

a) Sending URIT-1600 setting information: setting information will be sent when


URIT-1600 detects the first tube. Information format: start with "1600INFO:", using “:”
for separating each setting, and using “,” for separating name, information and other
content of setting. For example, the setting information is
(1600INFO:NO,0,0001:ID,1,0002), “1600INFO” is the fixed field, “:” used to separate
with following field. The first “0” in “NO,0,0001” means generation type of sample NO.,
and “0001” is the sample NO.. The “1” in “ID,1,0002” represents tube/tube rack, and
“0002” is tube rack NO..

NO 0: consecutive sample number; 1: discontinuous sample number

ID 0: barcode; 1: tube rack number

b) Results sending: results sent as the test is finished.

86

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