UD-1320 user manual

NOTE:
➢ Carefully read this manual before operating the analyzer in first time.
➢ Inspect the electrical requirements of the analyzer before power on,
and properly connect the grounding wire.
➢ Turn off the power t and pull out the power plug if the analyzer is idle
for a long time.
➢ Do not run the analyzer if it’s in an abnormal or damaged condition.
➢ 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.
CONTENTS
Copyright and Declaration .......................................................................................... i

How to use this manual ........................................................................................... vii
Chapter１ System Description ................................................................................. 1
1.1. Overview ..................................................................................................... 1
1.1.1. Product Principle ............................................................................... 1
1.1.2. Structure ........................................................................................... 2
1.1.3. Measurement items........................................................................... 3
1.1.4. Performance ..................................................................................... 6
1.1.5. Intended Use ..................................................................................... 8
1.1.6. Software ............................................................................................ 8
Chapter２ Precautions, Limitations and Hazards ..................................................... 9
2.1 Limitations .................................................................................................... 9
2.2 Installation Limitations .................................................................................. 9
2.3 Personnel Protection and Infection Control ................................................ 10
Chapter３ Installation ............................................................................................. 12
3.1 Unpacking and Inspection .......................................................................... 12
3.2 Installation Requirements ........................................................................... 12
3.3 Power Supply Inspection ............................................................................ 13
3.4 Tubing Installation ...................................................................................... 14
3.4.1 SHEATH tubing connection .............................................................. 14
3.4.2 WASTE Tubing Installation............................................................... 14
3.5 Installation of hose, IPU, display, keyboard, mouse ................................... 15
3.6 Power Connection ...................................................................................... 15
Chapter４ Components and Functions .................................................................. 17
4.1 Instrument introduction ............................................................................... 17
4.1.1 Instrument composition .................................................................... 17
4.1.2 Front panel ....................................................................................... 18
I
4.1.3 Rear panel ....................................................................................... 19
4.1.4 Side panel ........................................................................................ 22
4.1.5 SS Module ....................................................................................... 24
4.1.6 ST module is shown in Figure 4-8. ................................................... 25
4.1.7 YC module ....................................................................................... 26
4.2 The main structure and composition of the instrument ............................... 27
4.2.1 Photomicrographic system ............................................................... 27
4.2.2 Fluid System .................................................................................... 27
4.2.3 Control System................................................................................. 27
4.2.4 Identification Software ...................................................................... 28
4.2.5 Mechanical Device ........................................................................... 28
4.2.6 Input and Output .............................................................................. 28
4.3 Tube Rack .................................................................................................. 28
4.4 Reagent & Sample Consumption ............................................................... 28
4.5 Test Speed ................................................................................................. 29
4.6 Storage Capacity ........................................................................................ 29
4.7 Storage and Transportation Environment ................................................... 29
4.8 Normal Use Environment ........................................................................... 29
4.9 Electrical Requirement ............................................................................... 29
4.10 Reagents .................................................................................................. 29
4.10.1 Sheath ............................................................................................ 30
4.10.2 Detergent ....................................................................................... 30
4.10.3 Control and Calibrator .................................................................... 30
Chapter５ Daily Operation ..................................................................................... 32
5.1 Overview .................................................................................................... 32
5.2 Preparation................................................................................................. 32
5.3 Login .......................................................................................................... 33
5.4 Quality Control ........................................................................................... 34
5.5 Menu .......................................................................................................... 34
II
5.6 Sample Analysis ......................................................................................... 36
5.6.1List .................................................................................................... 36
5.6.2 Daily Test Interface ........................................................................... 39
5.6.3 Operation button .............................................................................. 40
5.6.4 Query and status .............................................................................. 41
5.6.5 Urine sediment test .......................................................................... 45
5.6.6 Artificial classification ....................................................................... 46
5.6.7 RBC Phase ...................................................................................... 47
5.6.8 Patient Information Input .................................................................. 48
Chapter６ IPU Setting ............................................................................................ 52
6.1 Settings ...................................................................................................... 52
6.2 User management ...................................................................................... 52
6.3 Dictionary maintenance .............................................................................. 54
6.4 Test items ................................................................................................... 54
6.4.1 Dry chemistry items setting .............................................................. 54
6.4.2 Urine sediment items settings .......................................................... 56
6.5 Print ............................................................................................................ 58
6.6 Data sending .............................................................................................. 59
6.7 Rule ............................................................................................................ 60
6.7.1 Test rule............................................................................................ 60
6.7.2 Prompt rules ..................................................................................... 62
6.8 Storage settings ......................................................................................... 63
6.9 Error prompt ............................................................................................... 63
Chapter７ Quality Control ...................................................................................... 65
7.1 Overview .................................................................................................... 65
7.2 QC Interface ............................................................................................... 65
7.3 Quality control setting ................................................................................. 66
7.4 Calculation method .................................................................................... 67
7.5 QC Test ...................................................................................................... 67
III
7.6 QC Print ..................................................................................................... 68
Chapter８ Maintenance .......................................................................................... 70
8.1 Basic operation .......................................................................................... 70
8.2 Maintenance plan ....................................................................................... 75
8.3 Maintenance record ................................................................................... 76
Chapter９ Troubleshooting ..................................................................................... 78
9.1 Troubleshooting Guidance ......................................................................... 78
9.2 Obtaining Technical Assistance .................................................................. 79
9.3 Troubleshooting .......................................................................................... 79
9.3.1 Startup Error .................................................................................... 79
9.3.2 Not display ....................................................................................... 80
9.3.3 Mouse Error ..................................................................................... 80
9.3.4 Keyboard Error ................................................................................. 80
9.3.5 Printer error ...................................................................................... 81
9.3.6 A warning message appears on the screen: the sheath/detergent has
a small amount of residual and needs to be swiped. ....................................... 81
9.3.7 Waste full ......................................................................................... 82
Appendix A: Instrument Icon and Symbols Specification ......................................... 83
Appendix B: Instrument Specifications .................................................................... 84
Appendix C: Trouble List ......................................................................................... 86
3. UD-1320 error handling ....................................................................................... 90
4. ST error handling ................................................................................................. 98
5. YC error handling .............................................................................................. 100
Appendix D: Parts List for Replacement ................................................................ 101
Appendix E: HL7 Protocol for URIT Urine Sediment Analyzer............................... 103
Appendix F: List of attachments ............................................................................ 112
Appendix G:Toxic and Hazardous Substances or Elements ................................. 113
IV
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-1320 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-1320 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-1320 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:
◆ Failure due to abuse the analyzer or neglect the maintenance.
◆ Use reagents and accessories other than manufactured or
recommended by URIT.
◆ Failure due to operation not under the instructions described in the
manual.
◆ Replace accessories not specified by URIT, or after maintenance or
repair by a service agent not approved or authorized by URIT
Instructions for use
This IVD medical equipment complies with the emission and immunity
requirements of IEC/EN 61326-2-6 and IEC/EN 61326-1.
The user should ensure that below compatible electromagnetic
environment for the equipment can be maintained in order that the device will
perform as intended.
Guidance and manufacturer’s declaration
1, Emission requirements for IVD medical equipment
Emissions test EMC Basic Test Limit Comply
Standard
Conducted emission CISPR 11 Group 1, Class A P
Radiated emission CISPR 11 Group 1, Class A P
Harmonic current IEC 61000-3-2 Class A P

emissions
Voltage changes, IEC 61000-3-3 -- P
Voltage fluctuations and
Flicker
2, Immunity requirements for IVD medical equipment

EMC Basic
Port Phenomenon Test Value Comply
Standard
Enclosure Electrostatic IEC 2 kV and 4 kV P
61000-4-2
discharge contact discharge
(ESD)
2 kV, 4 kV and 8 kV
air discharge
Electromagnetic IEC 3 V/m (80 MHz to 1 GHz) P
field 61000-4-3
3 V/m (1,4 GHz to 2 GHz)
1 V/m (2,0 GHz to 2,7 GHz)
Power IEC P
frequency 61000-4-8 3 A/m, (50 Hz, 60 Hz)
magnetic field
ii
AC power Voltage dip IEC 0 % during 1 cycle P

61000-4-11
(including 40 % during 5/6 cycles
protective
70 % during 25/30 cycles
earth)
Short IEC Less than 5 % during P
interruptions 61000-4-11 250/300 cycles
Burst IEC 1 kV (5/50 ns, 5 kHz) P
61000-4-4
Surge IEC 1 kV(Line to line) / 2 P

61000-4-5 kV(Line to earth
(ground))
Conducted RF IEC 3 V (150 kHz to 80 MHz) P
61000-4-6
DC power Burst IEC 1 kV (5/50 ns, 5 kHz) N/A
61000-4-4
(including
protective Surge IEC 1 kV(Line to line) / 2 N/A
61000-4-5 kV(Line to earth
earth)
(ground))
(Only in
Conducted RF IEC 3 V (150 kHz to 80 MHz) N/A
case of
61000-4-6
lines > 3
m)
I/O Burst IEC 0,5 kV (5/50 ns, 5 kHz) N/A
signal/cont 61000-4-4
rol
Surge IEC None N/A
(Only in 61000-4-5
case of
lines > 3
61000-4-6
m)
I/O Burst IEC 1 kV (5/50 ns, 5 kHz) N/A
signal/cont 61000-4-4
rol
Surge IEC None N/A
connected 61000-4-5
directly
to mains 61000-4-6
supply
iii
Warning: Use of this instrument in a dry environment, especially if

synthetic materials are present (synthetic clothing, carpets etc.), may cause
damaging electrostatic discharges that may cause erroneous results.
Warning: Do not use this instrument in close proximity to sources of
strong electromagnetic radiation (e.g. unshielded intentional RF sources), as
these may interfere with the proper operation.
Warning: This equipment has been designed and tested to CISPR 11
Class A. In a domestic environment it may cause radio interference, in which
case, you may need to take measures to mitigate the interference.
Advice: The electromagnetic environment should be evaluated prior to
operation of the device.
iv
CAUTION:
THE ANALYZER IS FOR PROFESSIONAL AND PRESCRIPTION USE
ONLY.
Technical service and troubleshooting are provided by URIT Customer
Support Center. Professional technician and sale representative will be sent to
offer you timely service when necessary.
URIT Medical Electronic Co., Ltd.
Address:No. D-07 Information Industry District, High-Tech Zone, Guilin,
Guangxi 541004, P. R. China
Tel: +86（773）2288586
Fax: +86（773）2288560
Web: www.urit.com
Email: service@uritest.com
Shanghai International Holding Corp. GmbH (Europe)

Eiffestrasse 80, 20537 Hamburg, Germany
Release note:
Version Revised contents
01/2017
01/2017-1 Optional SS module was added.
Optional ST module and YC module
01/2017-2
were added.
The templates of front/back cover were
changed. Production enterprise
01/2017-2-C1
telephone number and fax were
deleted.
01/2017-3 Appendix F was modified, and

Appendix G was added. According to
v
the latest technical requirements, the

electrical conductivity and osmotic
pressure test items were added, body
fluid test mode was added, the
software operation instructions was
update, and other relevant contents
were modified.
The address of European Authorized
01/2017-3-C1
Representative was changed.
Version: 01/2017-3-C1. Compiled in January 2017, first revised in June 2018,

second revised in October 2018, and third revised in May 2020.
vi
How to use this manual
This user manual contains general information on the use of the

instrument. This is the best guide for new users to use the instrument. Before
using it for the first time, users are advised to read this manual from beginning
to end. If you read this manual, you will learn about the features and operation
of the instrument. In your daily use, you can use the content to quickly find the
information you need.
Symbol Meaning
Denotes a hazard which, if not avoided, could

WARNING result in moderate to serious injury.
Denotes potential hazards that could result in

CAUTION a minor injury, also used for conditions or activities
which could interfere with proper function of the
analyzer.
Denotes special operator/service information
Note or standard practices.
Denotes potential bio-hazard.
All the illustrations provided in this manual are only for example purposes
and should not be used for other purposes. The graphics, settings, or data in
the illustration may not be exactly consistent with what you actually see on
UD-1320.
Statement:
➢ The equipment meets the emission and anti-disturbance requirements

specified in GB/T 18268.26-2010.
➢ This equipment is designed and tested according to Class A equipment in
GB 4824. In a domestic environment, this device may cause radio
interference and protective measures may be required.
➢ It is recommended to evaluate the electromagnetic environment
vii
How to use this manual
before the equipment is used.

➢ It is prohibited to use this device next to a strong radiation source (such as
a non-shielded radio frequency source), as this may interfere with normal
operation of the device.
CAUTION
➢ All personnel who use, move, and maintain the instrument should read this
manual.
➢ Please strictly follow the instructions in the manual.
➢ In the dry environment, especially in the dry environment where there are
artificial materials (artificial fabrics, carpets, etc.), the use of this equipment
may cause damaging electrostatic discharge, leading to wrong
conclusions.
➢ Do not use the device near strong radiation sources, as this may interfere
with normal operation of the device.
viii
Chapter１ System Description
Welcome to read the UD-1320 automatic urine sediment analyzer manual.
This manual includes the operation, maintenance instructions and precautions
of the instrument. In order to maintain good performance, the machine must be
operated and maintained in accordance with this manual.
1.1. Overview
UD-1320 automatic urine sediment analyzer (hereinafter referred to as

analyzer) is an in vitro diagnostic instrument suitable for analyzing and
counting the sediment in human urine. The instrument can be used to image
pattern recognition of visible components in urine, and finally obtain test data
to provide necessary reference for clinical diagnosis.
1.1.1. Product Principle
Adopting automatic recognition technology of digital imaging, planar flow

technology and flow and deep learning AI recognition technology, UD-1320
can intelligently classify and recognize the sediments in urine. It is a fully
automatic analyzer integrating electronics, optics, recognition software and
machinery.
Using planar flow cytometry, fluid system actuates sheath and sample to
form sheath--sample--sheath laminar flow, and restrains the thickness of
sample laminar flow to make sediments in sample solution flow in tiled status.
Tiled laminar flow is an important guarantee of clear image.
Optical system and digital camera constitutes digital imaging system. It

shoots sample’s sediments in shooting area of sheath flow regulator rapidly
and clearly.
Planar flow cytometry and digital imaging system are shown in Figure 1.
Intelligent recognition system can divide, identify and classify sediments.
1
System Description
Its highly optimized recognition algorithm guarantees accuracy of classification.

Meanwhile, system can save original drawings for manual classification,
results audit and recalls.
The measurement principle of the conductivity is mainly that the urine

sample is stimulated by AC frequency conversion signal, and the urine
electrical conductivity is obtained by combining signal amplification,
analog-digital conversion and Fourier transform technology. Then the osmotic
pressure value is obtained by using the correlation between conductivity and
osmotic pressure.
Figure 1 Planar flow cytometry and digital imaging system
1.1.2. Structure
The analyzer consists of a microscopic imaging system, fluid system,

control system, identification software, mechanical devices, and input and
output parts.
2
System Description
1.1.3. Measurement items
1）Urine sediment：
Sediment Sediment
No. Abbreviation No. Abbreviation
items subclass
Red blood cell

1 RBC 1 / /
count
Burry red blood

2 G1
cell
Red Blood Cell Coin red blood

2 RBCd 3 Coin
Deformability cell
Ghost red blood

4 Ghost
cell
5 White blood cell WBC

White blood
3 WBC
cell
6 Phagocyte Phagocyte
White blood
4 WBCC 7 / /
cell cluster
Squamous
5 SQEP 8 / /
epithelial cell
Transitional
9 TREP
Non-squamou epithelial cells
6 s epithelial NSE
cells Renal tubular

10 REN
epithelial cell
7 Hyaline cast HYA 11 / /
3
System Description
12 Granular cast GRAN
13 Waxy cast WAXY

8 Path cast PAT
14 Cellular cast Cellular
15 Mixed cast C-MIX
Calcium oxalate
16 monohydrate CaOxm
crystal
Calcium
9 CAOX
oxalate crystal Calcium oxalate
dihydrate crystal
17 CaOxd
Uric acid
10 URIC 18 / /
crystal
11 Struvite crystal Struvite 19 / /
Amorphous
12 phosphate AMOR 20 / /
crystal
Calcium
13 Other crystal OTCRY 21 CaPh
phosphate crystal
22 Coccus Cocci
Streptococcus
14 Bacteria BACT 23 Strptococcus
24 Bacillus Bacilli
4
System Description
25 Yeast YST
15 Fungus Molds 26 Candida yeast Candida
27 Fusarium FUSA
16 Mucous MUCS 28 / /
17 Sperm SPRM 29 / /
18 Other Other 30 / /
Note：the test items are updated as the recognition system evolves.
2）Urine physical measurement items：
The analyzer can measure urine conductivity and osmotic pressure.
3）Body fluid measurement items：
The analyzer can be used to test cerebrospinal fluid, thoracoabdominal

fluid and gynecological secretions. The test results are as follow：
Cerebrospinal fluid RBC, WBC
Thoracoabdominal fluid RBC, WBC
Gynecological secretions RBC, WBC, EP, BACT
4）RBC morphology test items
The analytic system can test ans display MCD, RDDW, R-RATE and RBC
diameter distribution histogram, or MCV, MCV-CV, R-RATE and RBC volume
distribution histogram.
5
System Description
1.1.4. Performance
1.1.4.1. Detection limit
The detection limit of RBC and WBC should be 5 /μL.
1.1.4.2. Repeatability
1.1.4.2.1 Repeatability of sediment test
The coefficient of variation of test results should meet the requirements in

Table 1-1.
Table 1-1 Coefficient of variation（CV）

Coefficient of variation（CV）
Sediment name
Concentration Requirement
50/μL ≤25%
RBC 200/μL ≤15%
600/μL ≤5%
1.1.4.2.2 Repeatability of conductivity and osmotic pressure
The coefficient of variation of conductivity and osmotic pressure should

meet the requirements in Table 1-2.
Table 1-2 Repeatability of conductivity and osmotic pressure
Item Coefficient of variation（CV）

Conductivity 16-20mS/cm ≤5.0%
Osmotic 504-642mOsm/kg ≤7.5%
pressure
6
System Description
1.1.4.3. Accuracy
1.1.4.3.1 Accuracy of sediment measurement
The accuracy of test results should meet the requirements in Table 1-3.
Table 1-3 Accuracy
Accuracy
Sediment name
Concentration Allowable variation
200/μL ±15%
RBC
600/μL ±5%
1.1.4.3.2 Accuracy of conductivity and osmotic pressure
The accuracy of conductivity and osmotic pressure should meet the

requirements in Table 1-4.
Table 1-4 Accuracy of conductivity and osmotic pressure
Items Accuracy
Conductivity 16-20mS/cm ±5%
Osmotic pressure 504-642mOsm/kg ±10%
1.1.4.4. Stability
The coefficient of variation (CV) of the test results should not be greater
than 15% within 8 hours after the analyzer startup.
1.1.4.5. Carryover rate
The carryover rate should not be greater than 0.05%.
7
System Description
1.1.5. Intended Use
UD-1320 Auto Urine Sediment Analyzer applies to the qualitative and

quantitative analysis of the urine sediment (including RBC, WBC, SQEP, NSE.
HYA, GRAN, CAOX, UNCRY ,URIC,BACT,YST,MUCS,SPRM,WBCC).
CAUTION
➢ The analyzer is a clinical examination instrument for screening. When

doctors make clinical judgment based on the analysis results, they should
also consider the clinical examination results or other experimental results
1.1.6. Software
Version:V5
8
Chapter２ 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.
2.1 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.
2.2 Installation Limitations
a) Instrument first installation must be performed by URIT authorized

engineer.
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

9
Precautions, Limitations and Hazards
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.
e) 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.
CAUTION
Anyone without authorization of URIT should NOT remove the screws on

the cover, or the customer must take all the responsibility.
2.3 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
10
Precautions, Limitations and Hazards
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.
11
Chapter３ Installation
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.
WARNING
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.
3.1 Unpacking and Inspection
Carefully remove the analyzer and accessories from shipping carton, keep
the kit for further transport or storage. Check the following:
⚫ Quantity of accessories according to the packing list;
⚫ Leakage or soakage;
⚫ Mechanical damage;
⚫ Bare lead, inserts and accessories.
Do contact URIT Customer Support Center if any problem occurs.
3.2 Installation Requirements
Please refer to section 2.2 of chapter 2.
12
Installation
WARNING
➢ Not for home use.
➢ Not for therapy.
CAUTION
➢ Keep the analyzer away from direct sunlight.
➢ Avoid temperature extreme.
➢ 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 door cannot be opened during the test.
➢ Keep no less than 20cm distance at the right side switch.
3.3 Power Supply Inspection
Be sure that the system is located at the desired site before attempting any
connections. See Table 3-1 for details.
Table 3-1 Power Supply Requirements
Optimum Voltage Range Frequency

operating voltage
220V~ AC100V~240 V 50/60Hz
13
Installation
CAUTION
➢ The grounding post of the rear panel of the instrument must be directly
connected to the grounding system of the user through the grounding wire.
The user is obliged to ensure the reliability of the power supply protection
ground of the instrument.
➢ Frequent fluctuations of voltage will lead to a decrease in the performance

and reliability of the instrument. Users should solve this problem before
using the instrument, such as installing the ac voltage stabilizer (provided
by the user).
➢ Frequent interruptions in power can result in severe degradation of

instrument performance and reliability. Users should resolve this issue
before using the instrument, such as installing an uninterruptible power
supply (UPS) (required by the user).
3.4 Tubing Installation
There are three connectors on the rear panel: SHEATH, WASTE, and
SENSOR. Each of which is wrapped with a cap to avoid contamination by
URIT before shipment. Uncover and set the caps aside carefully for further use
on initial installation.
3.4.1 SHEATH tubing connection
Remove the sheath tube with blue connector from the reagent package
and connect it to the fluid line connector labeled “SHEATH” on the rear panel of
the main unit. Connect the other end of the tube to the sheath tank and tighten
the bottle cover.
3.4.2 WASTE Tubing Installation
Remove the waste tube with black faucet from reagent kit and attach it to
14
Installation
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.
CAUTION
➢ Keep all lines in the natural state after installation. Do not forcibly twist.
➢ Do not use any tools but with hands to install the line joints.
➢ If found any abnormal occurrences, such as reagent bottles broken,

weeping 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.
3.5 Installation of hose, IPU, display, keyboard, mouse
Carefully take out the host, monitor, keyboard, mouse, etc. from the
packing box, install the keyboard and mouse respectively on the port
corresponding to the host, and connect the monitor with the VGA port using the
VGA line.
It is recommended to place the keyboard beneath the display.
3.6 Power Connection
Make sure the power switch is OFF (O) and the grounding terminal on the
15
Installation
rear panel is well grounded firstly, and then connect the analyzer to the main
power with the power cable.
16
Chapter４ Components and Functions
4.1 Instrument introduction
4.1.1 Instrument composition
The structure of the instrument is shown in Figure 4-1.
Figure 4-1 Instrument composition
1) The main unit of the instrument
The main unit of the instrument is used to test samples and is equipped
with a touch screen to facilitate control of the instrument and display of test
results.
2) ST module
ST module is used to pre-store the test tube racks and can hold up to 20
rows of test tube racks, for test tube rack number scanning, test tube barcode
scanning and detection of the presence or absence of test tubes.
3) SS module
SS module is used for pushing the test tube rack to test, scanning the test
17
Components and Functions
tube rack number and detection of the presence or absence of the test tube. It
is equipped with an emergency test function. It can be used independently
rather than in combination with ST module, and can be placed up to 6 rows of
test tube racks.
4) YC module
YC module is used to place the tested tube racks and can hold up to 20
rows of test tube racks. See details in Section 4.1.6 and Section 4.1.7 for ST
module and YC module.
4.1.2 Front panel
The front panel structure of the instrument is shown in Figure 4-2.
Figure 4-2 Front panel
18
1) Touch screen
Touch screen is for setting instrument parameters, controlling instruments

and displaying test results, etc.
2) Indicator
The indicator is used to display the working status of the instrument. The
status is described in Table 4-1.
Table 4-1 Description table of the Indicator status
Indicator status Description of instrument status
Red, always bright Error or warning arise and haven’t been solved.
Red, flashing It flashes 10 times when error or warning arise.
Green，always bright Standby or idle
Green，flashing Working (busy)
Blue，flashing Initializing (from standby to turn on / when it is reset).
Blue，breathing Sleeping
3) Sample probe outlet
4) The sample probe goes out for sampling from it.
5) Installation position of powerful cleaning liquid
The installation position of the powerful cleaning liquid is used to install

and replace the strong cleaning liquid bottle.
4.1.3 Rear panel
Figure 4-3 shows the board composition behind the instrument.
19
Figure 4-3 Instrument rear panel
1) Equipotential ground terminal
A ground system for connecting instruments to hospitals.
2) Power interface
Three-core power socket, can be connected to three-core power cord.
3) Fluid system interface
It is used to connect external reagents and remove waste liquid. For details,
please refer to Figure 4-4 below.
20
Figure 4-4 Fluid system interface
SHEATH
The sheath interface is connected with the sheath fluid.
SENSOR
The waste liquid sensor interface is connected with the waste liquid sensor
to detect whether the waste liquid in the waste liquid bottle is full.
WASTE
The waste liquid interface connects the waste liquid pipeline and discharge
the waste liquid.
4) Input/output interface
The specific definition of input/output interface is shown in Figure 4-5

below.
（1）Voice output （2）Voice input （3）Network interface
（4）USB （5）DVI interface （6）VGA video interface
（7）Serial port COM 1 （8）Serial port COM 2 （9）Mouse interface
（10）Keyboard interface
21
Figure 4-5 Input/output interface
4.1.4 Side panel
The instrument side panel structure is shown in Figure 4-6.
22
Figure 4-6 Side panel
1) Power switch
Main power switch.
2) Sheath activation area
It’s used to read sheath activation card.
23
4.1.5 SS Module
See Figure 4-7.
Figure 4-7 SS Module
1) Storage area of the to be tested tube racks
For storage of the to be tested tube racks, up to 6 rows of test tube rack
can be placed.
2) Test tube rack number detection
For reading rack number.
3) Infrared detection
For detecting whether there are tube racks in to be tested rack area.
4) Test tubes detection
For detecting whether there are tubes in corresponding rack position.
5) Placing hole for emergency tube
For emergency tube placement.
24
6) Emergency bottom
Press the button to start emergency test.
7) Storage are of tested tube racks
For storage of the tested tube racks, up to 6 rows of test tube racks can be
stored.
4.1.6 ST module is shown in Figure 4-8.
Figure 4-8 ST module
1) Autoloader placement area
It’s used to place the to be tested tubes and up to 20 rows tube racks can be
placed.
2) Network interface
Network connection. It’s used to transmit data.
3) Power input port
25
4) Power switch
ST module power switch.
5) Cover
It’s used to protect the samples in tube rack storage area after scanning
tube rack No. and barcode.
4.1.7 YC module
See Figure 4-9.
Figure 4-9 YC module
1) Recycled tube rack area
It’s used to place the to be tested tubes. Up to 20 rows tube racks can be
placed.
2) Network interface
Network connection. It’s used to transmit data.
3) Power input port

26
4) Power switch
YC module power switch.
4.2 The main structure and composition of the instrument
The analyzer consists of a microscopic imaging system, a fluid system, a

control system, identification software, mechanical devices, and input and
output parts.
4.2.1 Photomicrographic system
The microscopy system is mainly composed of xenon flash, light source

adjusting device, sheath flow pool adjusting device, objective lens, lens tube,
camera and focusing platform. It mainly completes the presentation,
amplification, photographing and recording of the sample images to be tested
in the sheath flow pool.
4.2.2 Fluid System
The fluid system is composed of solenoid valves, vacuum pump, force

pump, vacuum chamber and plastic tube.
Solenoid Valve--- Two-way or three-way solenoid valves control the flow of

fluid.
Force Pump --- Aspirate sheath liquid from reagent bottle into sheath tank.
Plastic Tube --- Reagent and waste flow in the plastic tube.
Vacuum Pump--- Pump the waste liquid into the waste container.
4.2.3 Control System
The control system is mainly divided into information processor device,

flow control device and switch power supply device.
◆ Information Processor Device

27
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.
◆ Liquid Control Processor
This part controls the entire instrument autoloading, and is responsible for
the switch of each valve and pump in the liquid path. To ensure that the sample
forms a stable sheath flow in the flow cell, in order to facilitate the collection of
images.
4.2.4 Identification Software
The identification software is used for processing, identifying and

classifying sample photos.
4.2.5 Mechanical Device
It is composed of ST module, SS module, sampling device, detergent

mounting device, circuit mounting bracket and microscope column.
4.2.6 Input and Output
It includes the the connectors of display, keyboard, printer, reagent and

liquid waste container.
4.3 Tube Rack
The test tube rack is for the analyzer dedicated, 10 tubes for each rack.
4.4 Reagent & Sample Consumption
Urine sediment (or nature urine)：1.2mL；
Sheath：17.5mL；
Detergent ：Use it every 150 measurements, 4-5mL/time；
28
Reagent consumption is various according to the software version.
4.5 Test Speed
URIT-1320 can process 120 samples per hour at most.
4.6 Storage Capacity
It can store more than 40,000 samples data.
4.7 Storage and Transportation Environment
a) Temperature: -10℃~55℃
b) Relative Humidity: ≤95%RH
c) Barometric: 75kPa~106kPa
4.8 Normal Use Environment
a) Temperature: 5℃~40℃
b) Relative Humidity: ≤85%RH
c) Barometric: 75kPa~106kPa
4.9 Electrical Requirement
Supply: AC 100V ~240V 50/60Hz
Fuse: T3.15AL250V
Power: 180~280 VA
4.10 Reagents
The reagents are formulated specifically for the URIT-1320 fluid systems 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-1320 is checked at the factory using the specified
29
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.
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.
4.10.1 Sheath
The sheath solution is mainly used for daily cleaning and maintenance of
the fluid system, the sheath flow regulator and the sample probe, and wrapping
sample to form sheath flow.
4.10.2 Detergent
Detergent（model：URIT D16）has a strong cleaning effect on the fluid

system, sheath flow regulator and sample probe. After 150 tests, the
instrument will automatically use the detergent to clean and maintain the fluid
system.
4.10.3 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
30
agents designated by URIT.
31
Chapter５ Daily Operation
5.1 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
Login
QC Contact engineers
Sample analysis
Rinse and shutdown
5.2 Preparation
Before startup, the operator must check the analyzer according to the
following requirements to make the analyzer ready.
➢ Waste Container
Before startup, operator needs to check the waste container to ensure it is

already empty or has enough capacity.
➢ Tubes and Power Supply

32
Daily Operation
Check whether the reagent tube and waste tube are connected firmly and
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.
5.3 Login
The login interface of Information Processing Unit (IPU for short) is shown
in Figure 5-1. Enter the account and password to log into the system. See
section 6.2 for details.
Figure 5-1 login interface
33
Daily Operation
5.4 Quality Control
To ensure reliable results, quality control analysis must be done every day
before sample analysis. Details please refer to Chapter 7.
5.5 Menu
Overview: all operating interfaces of IPU can be entered from the Menu
interface, including report, QC, list, status, IPU setup, instrument setup and
system setup. The interface is shown in Figure 5-2.
Figure 5-2 Menu interface
1) Report: click the to enter the report interface.
34
Daily Operation
2) Quality control: click the to enter the quality control
interface.
3) List：click“ ”to enter List interface.
4) Status: click the to enter the status interface.
5) IPU setting: click the to pop up the window of IPU setting.
Refer to "Chapter 6 IPU setting" for detailed operation.
6) System setting: click the to pop up the system setting
window, including online setting and test mode setting. The interface is
shown in Figure 5-3.
35
Daily Operation
Figure 5-3 System setting interface
◆ Equipment configuration: check the equipment to connect the system. The

US serial can only be checked separately. The other four models can be
configured in any combination.
◆ IPU server settings: the server is open by default when the system starts
up, and the server needs to be closed before changing the IP and port of
the server.
5.6 Sample Analysis
5.6.1List
Click " " in toolbar, as shown in Figure 5-4.
Function: Preset the work of test tube. (when the sample No. and rack No.
of test tube are coincident with the information in List, the test is done
according to the list.)
36
Daily Operation
Figure 5-4 List
（1）" ": Create a new item in list.
（2）" ": Delete the selected items in the list.
（3）" ": Save the selected items in the list.
（4）" ": You can modify the next emergency and next
sample in the dialog box, as shown in Figure 5-5.
37
Daily Operation
Figure 5-5 Next sample
List of worksheet: all lists are shown in the left area of list interface.
Information of test tube: Input the information of test tube that needs to set
work content, as shown in Figure 5-6.
Figure 5-6 Test Tube Information
Work content: Preset test content and patient information, as shown in

Figure 5-7.
38
Daily Operation
Figure 5-7 List
5.6.2 Daily Test Interface
Daily test interface is in the main menu interface, click on the

toolbar as shown in Figure 5-8.
39
Daily Operation
Figure 5-8 Report Interface
5.6.3 Operation button
Overview: The operation buttons are mainly used for daily common
operations. The interface is shown in Figure 5-9.
Figure 5-9 Operation button
1) “ ”：Delete the selected items in sample list.
2) “ ”：Preview the selected sample results.
3) “ ”:Print the selected sample results.
40
Daily Operation
4) “ ”：Send all selected samples to LIS.
5) “ ”：Save the results that are audited manually.
6) “ ”：Merge emergency test results.
5.6.4 Query and status
◆ Today's query: you can quickly check today's sample by clicking
in the lower left corner. The result of the query is
displayed in the list on the left, and the date is displayed in the status
box. As shown in Figure 5-10 below.
41
Daily Operation
Figure 5-10 Today's query
Senior Query：Query conditions box pops-up by clicking on 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
5-11.
42
Daily Operation
Figure 5-11 Senior Query
Note: When the state box in the lower left corner is displayed as
" ", the list shows all the samples of the day. When it is displayed
as “ ” , the list shows the samples that are searched

according to conditions of senior query as shown in Figure 5-12.
43
Daily Operation
Figure 5-12 Query status list
◆ The status includes: abnormal, to be tested, not test, testing, tested,

audited and printed.
◆ Abnormal: The test is abnormal
◆ To be tested: Next sample to be tested.
◆ Not test: New sample, no test.
◆ Testing: The sample being tested has not come out yet.
44
Daily Operation
◆ Tested: The test has been completed and the result has been given.
◆ Audited: Tested and audited samples.
◆ Printed: The report has been printed.
5.6.5 Urine sediment test
Ordinary Batch Test:
Step 1: Place the test tube rack to under test area correctly and click
on the interface.
Step 2: The instrument enters test status. When the test tube rack is detected
by the analyzer, the test tube rack will be moved and tested
automatically.
Step 3: The test process of sample status is To be Tested ->Testing ->Tested.

"Tested" means the sample is tested and the urine sediment result has
got.
Step 4: While the instrument is testing, you can input the patient data, review
the counting results automatically detected by the instrument, and
print the test report.
NOTE
Do not move or take out the test tube when testing in test waiting area.
Emergency Test
Step 1: Put the emergency sample tube into the emergency position and
press “ST” button. System will automatically sample the emergency tube
before the next one is sampled. After the completion of emergency sample
measurement, the system will automatically return to the normal
measurement.
45
Daily Operation
Step 2: After identification, the output results will be displayed in the main
interface as well. Unlike the normal test samples, the sample number of the
emergency sample starts with 9 and the tube rack/position has the word
“Emergency”.
5.6.6 Artificial classification
◆ Purpose--Mainly used for artificial audit and confirm test results. By

using the audit program, you can audit, analyze and confirm the urine
sediment analysis results of the instrument.
◆ Interface: As shown in Figure 5-13, the "RBC" in the middle of the title
in the upper right corner of the figure is a small image indicating the
type of item currently displayed. "639.9/uL" indicates the current item
result, the left and right arrows are used to switch items. Manual
classification process: if there are any particles that do not meet the
requirements, the "classification" operation is applied to the correct
project until all particles in the project are correct.
Figure 5-13 Artificial classification
46
Daily Operation
◆ Classification:
To classify "Gran":Double left-click on the project to select the to be

audited item. The cell diagram is shown in the right area. Left-click on the
"Gran" , the selected item turns into blue, and the unit bar has an arrow. Then
right-click on a cell that is thought to be a granular cast and you can sort that
cell into the granular cast. In the process of classification, the results of each
item will be calculated and updated automatically (see Figure 5-14).
Figure 5-14 To classify "impurities"
◆ Undo: A small map of the cells being classified will turn black, and a
right mouse click will undo the classification of the cells.
◆ Toggle items: You can use the button above the picture to toggle the
item. Or you can double-click the right side of the mouse to view the
item.
5.6.7 RBC Phase
Purpose--It is mainly used to provide average diameter, abnormal scale,
47
Daily Operation
distribution width CV and other data of RBC. Doctors can judge the source of
the red blood cells. As shown in Figure 5-15.
Abnormal Scale（%）= （Abnormal RBC Quantity / RBC Total Quantity）%
x i
Average Diameter（um）： x = i =1
Distribution Width CV（%）=
Figure 5-15 RBC Phase
5.6.8 Patient Information Input
Click at bottom left to pop up patient information input interface, as
48
Daily Operation
Figure 5-16 Patient Information Input
1) Normal Operation
1) Switch to the next input box-- Using keyboard TAB key or clicking with
mouse can switch to the next input box.
2) After information input, click to save patient information.
Sometimes the operator forgets to save, when he checks other sample

information, the dialog as shown in Figure 5-16 will pop up to prompt
whether to save the operation. Click "OK" to save, click "Cancel" to
cancel the operation.
49
Daily Operation
Figure 5-17 Save Dialog
3) No.: the sample number is automatically generated when the sample is

generated. No modification is required by default.
4) Case ID: Enter the patient case ID here.
5) Barcode-- Generally the bar code does not need to be input, the
analyzer can automatically access it.
6) Name-- Input patient's name in "Name" box.
7) Gender-- Select patient sex in the "Sex" drop-down list box. The
default gender is not required.
8) Age-- Select input mode in the "Age" drop-down list, and input patient
age before unit.
9) Bed ID -- Input patient bed number in "Bed No.” box.
10) Patient: select patient type in the "patient type" drop-down list or enter
patient type directly in the list box.
11) Sender Select the clinician in the "Clinician" drop-down list or enter the
clinician name directly in the list.
12) Department: In the “Department” drop-down list, select the inspection

department or enter the inspection department name directly in the list.
50
Daily Operation
13) Auditor: A user who is logged in to test. That user is the reviewer. The
logged in user is audited, and that user is the auditor.
14) Test time: This time is the system sample generation time, without
modification function.
15) Remark: Enter sample note information in the "notes" box.
51
Chapter６ IPU Setting
6.1 Settings
Overview: General settings include time format, system font and log switch
settings. The interface is shown in Figure 6-1.
Figure 6-1 General settings
6.2 User management
Overview: User management mainly manages user information, including

adding users, modifying user names and passwords, as shown in Figure 6-2.
52
IPU Setting
Figure 6-2 User management
1) Add user: the user can only be added in the login mode of admin user.
Fill in the user name and password directly in the blank line of the user
list. After filling in successfully, press the Enter key. The save button
will be grayed out. Click the Save button to complete the add user
operation.
2) Modify the user name: The admin user can log in to modify the user
name. Modify the user name directly in the user list, press the Enter
key when the fill is complete, and the Save button will light up and click
Save to complete the operation.
3) Change password: In admin user login mode, you can modify all user
passwords and admin user passwords in the user list. The user
password in the list can be directly modified. The old password can be
modified after modifying the admin password. Ordinary users can only
change their password in login mode, and the old password needs to
be confirmed when changing.
53
IPU Setting
6.3 Dictionary maintenance
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
Figure 6-3 Dictionary Maintenance
Operator can modify the information directly in the list, add the content in
the last line, or click mouse right button for delete.
6.4 Test items
Overview: Set the unit, display name, reference value, etc. of urine
sediment and dry chemistry items.
6.4.1 Dry chemistry items setting
The dry chemistry items setting include display, item, Lis communication ID,
display name, unit, reference and strip type setting to set result interface
54
IPU Setting
display and system online matching, etc., as shown in Figure 6-4.
Figure 6-4 Dry chemistry
1) Display: Check to display items in the result table. If not checked, it will
not be displayed.
2) Item: In online mode, the item name is used to match the dry chemistry
result item and can be edited.
3) Lis communication ID: In the connection LIS server mode, this item is
used to match the result item with LIS, which can be edited.
4) Display name: It is used to display the result name of the interface,

which can be edited.
5) Unit: select the displayed unit, including PLUS, SI, ENG and CONV,
and the "reference" will be automatically updated to the corresponding
set value when the unit is modified.
6) Reference: It represents the reference value when the unit is used.
55
IPU Setting
7) Gating rules: When the status of new sample is 【Gating】, measuring

Urine Sediment or not depends on the test results of Dry chemistry.( if
the test results are greater than gating rules, the Urine Sediment will
be measured; otherwise don’t measure.
8) Move up: Set the order of the results in the interface. Select the row
and click the move up button to move the row up.
9) Move down: set the order of the results in the interface. Select the row
and click the move up button to move the row down.
10) Save: After modifying the contents of the form, the save button will be
lit. Click the save button to save the modified data.
11) Cancel: Abandon the modification or exit the settings interface.
Strip types: 11FA, 12FA and 14FA represent the strip types used in the test.
This option must be corresponding to the strip used in the actual test,
otherwise the test results will be affected.
CAUTION
◆ The value of the dry chemistry "Lis communication ID" item cannot be
repeated with the urine sediment. The default urine sediment value is
less than 50, and the dry chemistry value is greater than 50.
6.4.2 Urine sediment items settings
Urine sediment items settings include display, item, Lis ID, name, unit, "-",
"+-", "+1" and "+2", which are used for display settings of the result interface
and online matching of the system, etc. The interface is shown in Figure 6-5.
56
IPU Setting
6-5 Urine sediment items settings
1) Display: Check to indicate that the item is displayed in the result table.
If it is not checked, it will not be displayed.
2) Item: English name of the item, cannot be edited.
3) Lis ID: In the connection LIS server mode, this item is used to match
the result item with LIS, which can be edited.
4) Display name: It is used to display the result name of the interface,

which can be edited.
5) Unit: Select the unit of the item, including uL, LPF, HPF, HalfRation,
Color, and Transparence. After the unit is modified, “-”, “+-”, “+1”, “+2”
will be automatically updated to the corresponding settings value. Unit
conversion：1/uL≈0.18HPF, 1/uL≈ 2.9 LPF.
6) “-”, “+-”, “+1”, “+2” indicate the semi-quantitative threshold, which is

divided into four files, namely: “-”, “+-”, “+1”, “+2” ". Fill in the result
57
IPU Setting
threshold in each file. If the result of the test is less than this value, and
the item unit is “HalfRation” , it will display the semi-quantitative result
of the file. (For example, according to the settings in the figure, if the
RBC result is 80, then "+1" will be displayed).
7) Move up: It is to set the order in which the results are displayed on the
screen, select the row and click the moving up button to move the row
up.
8) Move down: It is to set the order in which the results are displayed on
the screen, select the row and click the moving up button to move the
row down.
9) Default value: Click the default value button to restore the value set by
the production.
10) Save: After modifying the contents of the form, the save button will be
lit. Click the save button to save the modified data.
11) Cancel: Abandon the modification or exit the settings interface.
CAUTION
◆ The value of the dry chemistry "Lis communication ID" item cannot be
repeated with the urine sediment. The default urine sediment value is
less than 50, and the dry chemistry value is greater than 50.
6.5 Print
Overview: for selecting printers and printing templates, the interface is

58
IPU Setting
Figure 6-6 Print
1) Printer: click the drop-down list to select the printer, (click the refresh
button to refresh the printer).
2) Print Template: Print Template Settings.
3) Options: Print report, QC, Notes settings.
4) Save: Save your settings.
5) Cancel: Cancel modification or exit the program.
6.6 Data sending
This setting communicates to LIS mainly, see Figure 6-7.
Test mode: including full duplex and half -duplex. Full duplex indicates that
testing information is obtained from LIS server. Half-duplex indicates that
information is not obtained from LIS, only sending results.
LIS connection settings: fill in LIS server IP and port number; connect to
59
IPU Setting
LIS automatically function is checkable.
Sending rules: sending data to LIS.
Figure 6-7 Data sending
6.7 Rule
6.7.1 Test rule
Overview: for test rule in use, the interface is shown in Figure 6-8：
60
IPU Setting
Figure 6-8 Test rule
New default item: Indicates whether the automatically created sample is

tested for urinalysis and sediment by default.
1) Dry chemistry status: whether to test dry chemistry by default when

creating new.
2) Urine sediment status: whether to test sediments of urine by default

when creating new.
Automatic new rule: Indicates when the instrument will automatically

create a new sample.
1) Rule 1: A new sample record will be recorded when the rightmost

device connected to the test tube is found.
2) Rule 2: A new sample record will be recorded when there is a result

sent form instrument to IPU, but no sample in corresponding state (by
options).
61
IPU Setting
6.7.2 Prompt rules
Figure 6-9 Prompt rules
Rule of error handling: a procedure used when there is a problem with a

test tube holder or position scanned by multiple instruments.
1) Rule 1：Treating methods when the instrument on the far right did not
find a tube rack code.
2) Rule 2：Treating methods when the instrument not on the far right did
not find a tube rack code.
3) Rule 3：The tube rack barcode read by the rightmost instrument is

inconsistent with the sequential rack code.
4) Rule 4：The rightmost instrument finds that there is a gap in the test
tube.
Result prompt rule: it is for setting the results in which cases will be
highlighted in the list of reports and see what the sample prompts
62
IPU Setting
are.information is.
6.8 Storage settings
Overview: it is used to set the cleanup log and image data files, as shown
in Figure 6-10：
Figure 6-10 Storage settings
1) Log: When the file memory is larger than the set value, you can
choose to automatically clean or remind you to clean up.
2) Image data: It is like to the log, when the file memory is larger than a
certain value, you can choose to clean it automatically or remind you to
clean it.
6.9 Error prompt
Error prompt is mainly for voice broadcast settings. See Figure 6-11:
63
IPU Setting
Figure 6-11 Error prompt
1) Prompt Tone: turn on or off prompt tone
2) Voice broadcast: select broadcast content, including default prompt

content and broadcast specific error.
3) Prompt time: you can select broadcast number of times and time.
64
Chapter７ Quality Control
7.1 Overview
To understand the status of the analyzer, it is recommended to run quality

control before test every day. If the result is within the control, the analyzer is
normal. If the result is out of control, you can find reasons from the microscope
focus (see Chapter 8), the status of control materials and so on. Run quality
control after the adjustment, and the samples can be tested when the result is
within the control.
7.2 QC Interface
As shown in Figure7-1.
Figure 7-1 QC Interface
◆ Today's QC: It is located on the left side of the QC interface and is

divided into two lists. The above list is used to check whether all the
quality control have passed today, including the Lot number, analyzer,
remarks, status (untested, testing, controlled, out of control); The
following list shows the specific project results and status of the QC
65
Quality Control
selected in the above list (↑: exceeds the upper limit; ↓: below the lower
limit; √: the result is in the upper and lower limits).
◆ Historical quality control: It is in the middle and right side of the quality
control interface and is divided into three areas. Query area: You can
query by selecting the month, instrument and lot number. QC chart
area: Display the data in the query as LJ quality control chart. Result
display area: Display the data results of the query by date in the list.
7.3 Quality control setting
Figure 7-2 Quality control parameter
As shown in Figure 7-2, the quality control parameter interface is divided

into two parts. The upper part is used to fill in the quality control lot number,
applicable instrument, validity period of quality control, remarks. The table in
the lower part is used to represent the reference value, upper and lower limit of
each quality control item selected in the above table.
Operation:
66
Quality Control
◆ Add: Switch the line or click the save button after filling in the
corresponding information in the blank line.
◆ Delete: Delete all the contents of the line, or right click on the delete menu.
◆ Modify: Change the content of the selected line, switch the line or click the
save button.
7.4 Calculation method
The calculation method of the quality control test results is shown in Table
7-1.：
Table 7-1 Calculation method
Average ( x )
x i
x= i =1
Standard
SD =
 (x i − x) 2
deviation(SD) n −1
Coefficient of SD
CV =  100%
variation（CV） x
7.5 QC Test
1．Manual quality control: Click the manual quality control button on the
quality control interface, the manual quality control dialog box will pop up, as
shown in Figure 7-3. In the dialog box, select the instrument that needs to test
the quality control and the lot number of the quality control object, and click OK.
After that, test the control materials on the corresponding instrument. (You can
follow the prompts in the dialog box).
67
Quality Control
Figure 7-3 Quality control test inquiry
2.Automatic quality control test: When testing the sample, the scanned
barcode is the quality control lot number, then the sample is tested as quality
control material. Test results will appear in the quality control interface.
7.6 QC Print
Print the quality control test results. Figure 7-4 below is the printed quality
control report.
68
Quality Control
Figure 7-4 QC Report
69
Chapter８ Maintenance
This chapter describes the related operations of instrument maintenance.
The maintenance of the instrument is performed on the software built into the
instrument and can be operated directly on the touch screen. Maintenance of
the instrument includes changing the sheath fluid and detergent, maintenance
settings, maintenance records and so on.
8.1 Basic operation
The instrument maintenance interface is shown in Figure 8-1：
Figure 8-1 Maintenance interface
1. Change sheath
Chang sheath interface as shown in Figure 8-2.
When the system prompts you to change sheath, register it by the

procedure of changing sheath. The operator will operate according to the
70
Maintenance
prompts in the software interface. If the activation is successful, a cleaning

prompt will be provided. If the activation fails, the software will prompt the
failure of activation.
Figure 8-2 Change sheath
2. Chang detergent
Figure 8-3 shows the interface for changing detergent.
When the system prompts you to change detergent, register it by the

procedure of changing detergent. The operator is prompted by the software
interface. After clicking "out", the empty bottle will be popped out. The operator
can replace the new detergent bottle under the condition of ensuring his own
biological safety. Then click the "In" button to complete the replacement.
71
Maintenance
Figure 8-3 Changing detergent
3. Flush
Click the “Rinse” button, the instrument will perform the rinsing operation.
The status information prompt bar of the instrument indicates that the
instrument is rinsing.
4. Auto focus
When the microscope is out of focus or the instrument prompt for auto
focus, click the "autofocus" button, as shown in Figure 8-4.
Figure 8-4
72
Maintenance
Add focus solution into test tube and put it to emergency position. Click
"OK" to start auto focus procedure. Figure 8-5 and Figure 8-6 are the prompts
after the completion of auto focus.
Figure 8-5
Figure 8-6
“Focus success”indicates that auto focus has completed, and you

can proceed to the next step. If it prompts“Focus failed. Please manually
73
Maintenance
debug first.”, please perform Auto focus again. After 5 times, there is still no
prompt of "Focus success", please contact the after-sales engineers.
4. Tube rack induction
Tube rack sensing interface is shown in Figure 8-7.
The tube rack sensing procedure is used to test whether the test tube bar
code scanning mechanism is running normally. According to the software hint，
place the tube rack to be scanned at the test-tube rack scanning place of the
sampling platform. Click the "Scan" button, and the instrument will
automatically scan the tube rack and report the number. If the scanned number
of the is not consistent with the actual situation, it indicates that the scanning
mechanism of the test tube rack of the instrument has a fault. If multiple
scanning cannot solve the problem, please contact the after-sales engineer to
deal with it.
Figure 8-7 Test tube rack sensing
6.Tube induction
The tube sensing interface is shown in Figure 8-8.
The test tube induction procedure is a tool used to test whether the test
tube recognition mechanism is in normal operation. According to the software
74
Maintenance
hint, randomly load the test tube to be scanned into the sampling platform, and
click "Scan" button. The device will automatically scan the test tube in the tube
rack and give the tube position number. If the position number of the tube
scanned is not consistent with the actual situation, it indicates that the tube
scanning mechanism is abnormal. If the operator cannot solve the problem,
please contact the after-sales engineer to deal with it.
Figure 8-8 Tube induction
8.2 Maintenance plan
The maintenance plan is divided into three parts: daily, weekly, and
monthly, as shown in Figure 8-1.
1、Daily
The cleaning of sheath flow regulator and tubing can be set to

automatically clean after testing 150 samples. This function cannot be turned
off.
Changing sheath shows how many times of test after sheath replacement.
This function cannot be turned off.
Changing detergent shows how many times of test after detergent

replacement. This function cannot be turned off.
75
Maintenance
The condition of image focus is 7 days or the temperature change is

greater than 12 ℃. When conditions are met, the system prompts the operator
to focus manually. To ensure the normal operation of the instrument, it is
recommended that the operator manually focus the image after the instrument
is prompted. This function cannot be turned off.
The cleaning of sample probe can be set to be cleaned once a week. This
function can be turned off.
2、Weekly
The sampling platform and inductor are cleaned on every Monday morning.
Cleaning work can only be done manually by the operator. When this function
is turned on, the instrument will give you a prompt at the appropriate time. In
order to ensure the normal operation of the instrument, it is recommended that
the operator manually clean the sampling platform and inductor after the
instrument prompts.
The purpose of cleaning the tube rack is to ensure that the tube rack code
is clear and increase the test tube rack recognition rate. It’s cleaned on every
Monday morning. In order to ensure the normal operation of the instrument, it
is recommended that the operator manually clean the tube rack after the
instrument prompts.
3、Monthly
Moving parts are maintained manually in the first week of each month. In
order to ensure the normal operation of the instrument, it is recommended that
the operator manually maintain the moving parts after the instrument prompts.
8.3 Maintenance record
The maintenance record interface is shown in Figure 8-9. The system

displays daily, weekly, and monthly maintenance items. The green dot on the
date indicates that maintenance was performed on that day. The operator can
76
Maintenance
query the maintenance record through the operation area on the right side of
the interface.
Figure 8-9 Maintenance record
77
Chapter９ 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.
9.1 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
78
Troubleshooting
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.
9.2 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:
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.
9.3 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.
9.3.1 Startup Error
Probable Cause:
① Analyzer power receptacle damaged;
79
Troubleshooting
② the fuse in the rear panel melted.
Corrective Action:
① Replace the analyzer power receptacle.
② Replace the fuse on the rear panel.
9.3.2 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.
9.3.3 Mouse Error
Probable Cause:
① the cable of mouse was loose;
② the mouse was broken.
Corrective Action:
① Reconnect the cable well.
② Replace the mouse.
9.3.4 Keyboard Error
Probable Cause:
① The keyboard cable was loose;
② The keyboard was broken.
80
Troubleshooting
Corrective Action:
① Reconnect the keyboard cable well.
② Replace the keyboard.
9.3.5 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.
9.3.6 A warning message appears on the screen: the sheath/detergent

has a small amount of residual and needs to be swiped.
Probable Cause:
The detergent/sheath used up.
Corrective Action:
1) Replacing detergent/sheath
2) In the menu of instrument operation on the screen, click the key of

"sheath registration"/" change detergent ", and activate the instrument
with the matching reagent card.
81
Troubleshooting
9.3.7 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.
82
Appendix A: Instrument Icon and Symbols
Specification
Caution Biohazard Lot No.
In Vitro
Shock Diagnostic
Validity
hazard medical
device
Protect from Date of

Serial
heat and manufactur
number
radiation e
Environment
Manufactur
-friendly use Equipotential
er
period
Electronic
Protective
products Alternating
conductor
recycling current
terminal
logo
Consult
instructions Power on Power off
for use
Protect
Upward Fragile
from water
Protect from No turning

Stacking limit
heat over
Ethernet USB
Fuse
interface interface
Serial port
83
Appendix B: Instrument Specifications
Dimensions and Weight Environmental Requirements
Dimension: Temperature: 5℃~40℃
698mmx674mmx575mm （ DS Relative Humidity: ≤85%RH
module）
Barometric: 75kPa~106kPa
631mmx702mmx575mm （ SS
Power Specifications
module）
Power Supply: AC 100V ~240V
Weight: host 57.8kg
50/60Hz
AS200: 14.25kg
Fuse: T3.15A L250V
Transport and Storage
Specifications Power: 180~280VA
Temperature: -10℃~55℃
Relative Humidity: ≤95%RH
Barometric: 75kPa~106kPa
Appearance Specifications
Display: 22-inch LCD / touch screen；
Language: English/Simplified Chinese
Parameters
Abbreviation Full Name

RBC red blood cell
WBC white blood cell
SQEP squamous epithelial
NSE Non-squamous
epithelial cells
HYA Hyaline Cast

GRAN Granular Cast
CAOX Calcium oxalate crystal
84
UNCRY Unclassified crystal
URIC Uric Acid crystal
BACT Bacteria
YST Yeast
MUCS Mucus
SPRM Sperm
WBCC White blood cell cluster
Ports
（1）Network Interface （2）USB （3）DVI video interface
（4）VGA video interface（5）Serial port （6）HDMI video interface
（7）Mouse interface （8）Keyboard interface
Sample / Reagent Consumption
Urine Sediment（or the original urine）：1.2mL；
Sheath：17.5mL；
Detergent ：Use it every 150 measurements, 4-5mL/time；
Note: Reagent consumption is various according to the software version.
Contraindication：None.
85
Appendix C: Trouble List
1. Description of sample status
Code Information Type Solution Description
4 Finished - Sample test has finished.
Determine whether to test

3 Gating - urine sediment according to
dry chemistry results.
It will be tested, but haven’t
0 To be tested -
been sampled.
Samples are being tested.
1 Testing -
Waiting for the results.
2 Not to test - The sample won’t be tested.
Samples have been tested, but

-1 No results Test again
no results.
-2 No image files Test again No image files found
Image files The image file cannot be

-3 Test again
error recognized.
No test tube
-4 Test again Unsampled and no results.
found
Insufficient
Fluid system optocoupler no
-90 samples or Test again
reaction.
hematuria
Check whether the
camera connection
The camera is is normal. It is
-91 not working recommended to Anomalous camera connection
properly power off and restart
the system and test
again.
86
Trouble List
The acquisition It is recommended

card is not to power off and The acquisition card is working
-92
working restart the system abnormally
properly and test again.
The acquisition card analyses
Abnormal cell cells abnormally. It is
-93 Test again
analysis recommended to power off and
restart the system
Sheath flow error, and it ended
Sheath flow
-94 Test again unexpectedly or did not
error
execute.
The concentration is greater

High
-95 Audit manually than the upper limit of the
concentration
instrument.
Brightness Settings are
-97 Low light Test again
required.
Brightness Settings are
-98 High light Test again
required.
Bacteria and
It prompts when both bacteria
amorphous
-101 Audit manually and amorphous crystals are
crystals may
positive
interfere
87
Trouble List
2. IPU error handling
Code Message Type Solution Description
Check whether the server Network anomaly.

The server
T-I001 Error IP setting is correct in The network port is
failed to open.
Setting interface. occupied.
Check the network；
Confirm the IP and port of
LIS, and check the setup
Failed to Unable to connect to
T-I002 Error of LIS server in Setting
connect LIS. LIS.
interface.
Check whether the LIS
server is open.
Check the network

of.sub-instrument.
Communicati Check the connected IP
Sub-instrument hasn't
T-I003 on connection Error address and port.
been connected.
error
Please make sure that the
sub-instrument
communication is normal.
Sub Please solve the error on
There is an error in the
T-I004 instrument Error the corresponding
sub-instrument.
error! sub-instrument.
Recognition module
abnormal (not
external)
◆ Clear away
Please restart the loghelp.
Log module
T-I005 Error software or contact the
loading error ◆ VGA driver error.
after sale department.
◆ Whether the task
manager has
multiple running
programs.
Check whether the tube The corresponding
In bridge holder on the bridge is tube rack does not
T-I006 Error
timeout! blocked or removed. enter the target
Confirm that the instrument within 2
88
Trouble List
corresponding test tubes minutes.

are on the sub-instrument
and then click Solve.
This error occurs in
Unable to
Click Solve to stop and case of closing the IPU
T-I007 maintain the Error
eliminate errors. software without
running state
stopping last time.
89
Trouble List
3. UD-1320 error handling

1. Restart the
system； Serial port failed to
Open
2. If the fault is still open. Check the
T-D004 communication Error
unsolved, contact industrial control
port failed!
our after-sales board serial port.
service engineer.
It has been 7
Click Solve and it It has been more
days since last
T-D005 Error performs than 7 days since
focus. Please
autofocus. the last autofocus.
autofocus!
1. Check the The INC or IPU

network network Settings are
Server not connection setting incorrect；
responding. of IPU；
T-D020 Error IPU firewall
Make sure 2. If the fault is still problem；
server is on unsolved, contact
our after-sales Improper network
service engineer. connection；
Click Solve and

the instrument
Change dete. performs the Detergent has been
T-D021 Error
and active process of used up.
detergent
replacement .
Click Solve and
the instrument
Change sheath Sheath has been
T-D022 Error performs the
and active! used up.
process of sheath
replacement .
Click Solve
T-D023 Waste full Error after disposal of Waste liquid is full.
the waste liquid.
Temperature Click Solve and Instrument

variation is out the instrument temperature
T-D024 Error
of range. performs changes over 12℃
Please autofocus. since last focus.
90
Trouble List
autofocus.
Click Solve after

The left sampling
Sample loader removing the tube
T-D025 Error platform is full of
full racks on the left
tube racks.
sampling platform.
Power off and No acquisition card

Cannot found restart the system； device found.
acquisition 2. If the fault is still Acquisition card
T-D026 Error
card！Power off unsolved, contact failure；
and restart! our after-sales Industrial board
service engineer. PCIE failure；
1. Power off and Poor contact of

restart the system； acquisition card
Acquisition card golden fingers leads
T-D027 error! Power off Error 2. If the fault is still
to RD data error.
and restart! unsolved, contact
our after-sales Acquisition card
service engineer. failure；
1. Power off and Failed to open the

Open restart the system； acquisition card；
acquisition card 2. If the fault is still Acquisition card
T-D028 Error
failed! Power off unsolved, contact failure；
and restart! our after-sales Industrial board
service engineer. PCIE failure；
Click Solve and At sample probe

the instrument initial position,
resets optocoupler
automatically. detection abnormal.
2. If the fault is still The baffle of sample
unsolved, contact probe is not in place.
Needle our after-sales
T-D029 initialization Error Optocoupler is
service engineer.
error broken；
Vertical motor of
sampling
mechanism is
broken；
The sample probe
does not run
91
Trouble List
smoothly；
Main control board is
broken.
1.Click Solve and At emergency initial
the instrument position, optocoupler
resets detection abnormal.
automatically.
The baffle of
2. If the fault is still horizontal motor of
unsolved, contact sampling
our after-sales mechanism is not in
service engineer. place.
；
Optocoupler is
Emergency broken；
T-D030 initialization Error
error Horizontal motor of
sampling
mechanism is
broken；
；
The sampling
mechanism is not
smooth when
running laterally；
Main control board is
broken.
1.Click Solve and Reset optocoupler of
the instrument detergent module
resets detection abnormal.
automatically.
Optocoupler is
Detergent 2. If the fault is still broken；
T-D031 initialization Error unsolved, contact
error Motor of detergent
our after-sales
module failure；
service engineer.
Rack of guide rail of
detergent module
failure；
Detergent 1.Click Solve and After using

T-D032 Error
return error the detergent detergent, reset
92
Trouble List
module resets； optocoupler

detection abnormal.：
2. If the fault is still
unsolved, contact Optocoupler is
our after-sales broken；
service engineer.
Motor of detergent
module failure；
Rack of guide rail of
detergent module
failure；
1.Click Maint. and Detergent bottle

“Change detection switch
detergent”, and abnormal：
operate according
Detergent bottle is
to the prompts.
not in place；
Detergent bottle 2. If the fault is still
T-D033 initialization Error Travel switch is
unsolved, contact
error adjusted to a
our after-sales
rearward position so
service engineer.
that it cannot touch
the detergent bottle；
Travel switch is
broken；
1. Click Solve and Detergent bottle

operate according detection switch
to the prompts.； abnormal：
2. If the fault is still Detergent bottle is
unsolved, contact not in place；
Detergent bottle our after-sales
T-D034 Error Travel switch is
location error service engineer.
adjusted to a
rearward position so
that it cannot touch
the detergent bottle；
Travel switch is
broken；
1. Click Solve and Acquisition card

the instrument video brightness
High light, Set
T-D035 Error performs auto value is larger than
auto brightness.
brightness； 180：
2. If the fault is still Whether the
93
Trouble List
unsolved, contact connection of the

our after-sales flash is normal；
service engineer.
Camera data cable
connection problem；
Acquisition card
1. Click Solve and video brightness
the instrument value is less than
performs auto 50：
Low light, Set brightness；
T-D036 Error Whether the
auto brightness. 2. If the fault is still connection of the
unsolved, contact flash is normal；
our after-sales
service engineer. Camera data cable
connection problem；
Horizontal
T-D038 motor reset Error
error 1. Click Solve, and The optocoupler
the sampling baffle is not in the
Rack in motor
T-D039 Error mechanism resets slot switch position；
error
automatically；
Right rack out Optocoupler is
2. If the fault is still broken；
unsolved, contact
error Motor failure, not
our after-sales
Left rack out service engineer. running；
error
The number of
Click Solve and sheath use is to the
the instrument limit；
Active reagent
T-D042 Error performs the Sheath is used up
card
process of and the number of
changing sheath； use is more than
900.
Check the The tube rack is not
transmission belt. put in place within
If there is a test the time limit；
T-D043 In bridge error Error
tube rack on it,
manually remove it The test tube rack is
and click Solve； pushed askew；
94
Trouble List
1.Power off and The acquisition card

restart the is detected when
instrument； instrument is turned
PCIE DMA
on. DMA data
T-D044 error, power off Error 2. If the fault is still transmission
and restart. unsolved, contact between PCIE and
our after-sales industrial control
service engineer. board is abnormal
Click Solve； Abnormal

communication
Sample unit 2. If the fault is still between injection
T-D045 communication Error unsolved, contact mechanism board
failure our after-sales and industrial control
service engineer. CAN；
Click Solve； Abnormal
Liquid plate 2. If the fault is still communication
T-D046 communication Error unsolved, contact between fluid system
error our after-sales board and industrial
service engineer. control CAN；
The acquisition card

1.Power off and initialization state
restart the value is not 0；
PCIE instrument； Acquisition card
initialization
T-D047 Error 2. If the fault is still failure；
failed, power off
and restart. unsolved, contact Communication
our after-sales problem between
service engineer. acquisition card and
industrial control.
1.Power off and
restart the Acquisition card
Flashlight works instrument； video brightness
abnormally, value is less than 50:
T-D048 Error 2. If the fault is still
power off and check the
restart. unsolved, contact connection of the
our after-sales flash cable.
service engineer.
Temperature 1. Click Solve； Abnormal

plate communication
T-D049 Error 2. If the fault is still between
communication
unsolved, contact temperature board
error
our after-sales and industrial control
95
Trouble List
service engineer. CAN;
Acquisition card
Click Solve, and
video brightness
Set auto the instrument
T-D050 Error value is 160~180：
brightness performs auto
the exposure delay
brightness；
parameters is reset；
Fluid is empty, Click Solve, and

The fluid system is
T-D051 please Prime Error the sheath is
empty；
sheath. primed；
Click Solve and Fluid system board

the instrument didn’t execute the
T-D052 Sampling error Error
resets command sent by
automatically； INC；
The area of impurity

pixels is greater than
8000：
1.Power off and
Too many restart the system； There are dirty spots
on the camera or
impurities, 2. If the fault is still sheath flow
T-D053 Error
power off and unsolved, contact regulator. Perform
restart our after-sales rinse；
service engineer.
There is a problem
with the fluid
system；
Camera init
error，please 1.Power off and The reset value of
check whether restart the system； acquisition card
the camera 2. If the fault is still camera is not equal
T-D054 Error
connection is unsolved, contact to 0x445566：check
normal, power our after-sales the connection of
off and restart service engineer. camera cable；
the system.
1.It’s
recommended to It’s recommended to
check whether the check whether the
Maintain
T-000A Warning moving parts such moving parts such
moving parts
as lever and belt as lever and belt are
are running running normally；
normally；
96
Trouble List
2.Click Solve to
eliminate the
message；
1. It’s
recommended to
Clean sheath clean the pipes； It’s recommended to
T-D060 flow regulator Warning
2.Click Solve to clean the pipes；
and tubing
eliminate the
message；
1. It’s
recommended to
It’s recommended to
clean the the dirt
clean the the dirt left
left by the
T-D061 Clean Needle Warning by the sampling
sampling probe；
probe；
2.Click Solve to
eliminate the
message；
1. It’s
recommended to
clean the the dirt
on sampling It’s recommended to
Clean sample
platform and clean the the dirt on
T-D062 loader and Warning
inductor； sampling platform
sensor
and inductor；
2.Click Solve to
eliminate the
message；
1.It’s
recommended to
clean the dirt on It’s recommended to
Clean sample tube racks；
T-D063 Warning clean the dirt on tube
rack
2.Click Solve to racks；
eliminate the
message；
97
Trouble List
4. ST error handling

Loading rack
pushing motor M1 Click Solve and try
T-S101 Error
reset failure, click again.
"solve" to retry.
Scanning area
lever M2 reset Click Solve and try Check whether the
T-S102 Error
optocoupler again. optocoupler baffle of
failure. the corresponding
Rotating tube motor is in the slot
area motor M4 Click Solve and try switch position.
T-S103 Error
reset failure, click again. Check whether the
"solve" to retry. slot switch of the
Motor M5 reset corresponding motor
Click Solve and try is damaged.
T-S104 failure, click Error
again.
"solve" to retry.
Unload rack from
bridge motor M6 Click Solve and try
T-S105 Error
reset failure, click again.
"solve" to retry.
S1 Optocoupler Check whether there
Click Solve and try
T-S201 Does Not Detect Error are tube racks on the
again.
Tube Holder. corresponding
optocoupler.
302 optocoupler
error after Remove the tube Check whether the
scanning bar racks on scanning corresponding
T-S202 Error
code, remove channel and click optocoupler is
racks and click Solve. damaged.
"solve".
Check whether the
corresponding
Make sure the optocoupler is
Unload rack not tube rack is in the damaged.
T-S203 Error
found. right position, and
click Solve. Counting error or the
tube racks are
removed manually.
T-S301 Communication Error The optocoupler Check whether the
98
Trouble List
error in rack which detects tube sequence of

number scanning presence failure. communication line
module, click is correct.
Click Solve and try
"solve" to retry.
again. Check whether the
card reader burns
the program.
99
Trouble List
5. YC error handling

Check whether the
Loading rack
Resend the optocoupler baffle of the
pushing motor M1 corresponding motor is in
reset
reset optocoupler
T-Y101 Error command and the slot switch position.
malfunction,
clear the Check whether the slot
please click
error. switch of the corresponding
"solve" to retry.
motor is damaged.
Check if a test tube rack
Remove the covers the optocoupler.
YC Rack full,
T-Y301 Error tube racks on
please remove. Check whether the
YC module
optocoupler is damaged.
No test tube holder was
detected by the
YC Rack load Make sure the corresponding optocoupler.
over time, please tube rack is in
T-Y401 Error Optocoupler is broken or
confirm rack is in and click
not；
and click "solve". Solve.
It’s human intervention or
not.
100
Appendix D: Parts List for Replacement
Serial No. Name Remark

1 Power Supply
2 Fuse
3 Fixed size lens cone
4 Camera
5 Flashlight
6 40X objective lens
7 Image capture card
8 Three-way Solenoid
Valve
9 Two-way Solenoid Valve
10 Plunger pump Including motor
11 Plane sheath
12 Vacuum pump
13 Liquid pump
14 Air pump
15 Plastic tube
16 Silicone tube
17 Sampling unit Including motor

18 Sample loader Including motor
19 Sample probe
20 Probe wiper
21 Main control panel
22
Sample control panel
23 Power switch board
101
Parts List for Replacement
24 Temperature capture
board
25 Industrial control
computer
26 LCD
27 Mouse
28 Keyboard
29 Monitor
30 Touch screen
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.
102
Appendix E: HL7 Protocol for URIT Urine Sediment
Analyzer
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
103
HL7 Protocol for URIT Urine Sediment Analyzer
<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.
- 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|[I
nstrType]|P|2.3.1||||||UNICODE<CR>
PID|[PatType]|[PatID]|[PatBarCode]| [PatBedCode]|[PatName]|| [PatBirth]|

[PatSex]<CR>
104
OBR|[SampleType]|[REQID]|[SampleID]|[CompanyName]^[InstrName]||[S
ampleTime]|[StartTime]||||||[Symptom]||[SanpleType]|[SendDOCName]||
[SendDP]<CR>
OBX|1|[ValueType]|[ItemID]|[ItemName]|[TestResult]|[Unit]|[ConsultValue]|[Fla
g]|||F||[OD]|[ItemResultTime]|[DocDP]|[DOCName]|[Method]<CR>
OBX|1|ED|[ ItemID]|[ItemName]|[InstrID]Îmage^[FormartName]^Base64^
Qk02XgEAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA…||||||F|||[ ItemResu
ltTime]|[ DocDP]|[ DOCName]|
<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|[I
nstrType]|P|2.3.1||||||UNICODE
Identifier Meaning Format

[Company Company Name ASCII Character String
Name]
[InstrNam Instrument Name ASCII Character String
e]
[ResultTim Result Sent Time yyyyMMddhhmmss
e]
[InstrType] Instrument Type ASCII Character String
For example：
MSH|^~\&|URIT|UT-1200|LIS|PC|20101010093505||ORU^R01|URIT-USA|
P|2.3.1||||||UNICODE
E.2.4.4 Patient Data Meaning：
105
PID|[PatType]|[PatID]|[PatBarCode]| [PatBedCode]|[PatName]|| [PatBirth]|

[PatSex]<CR>

[PatID] Patient ID.（Optional） ASCII Character String
[PatType] Patient Type 1 byte ASCII Character String
1Normal
2 Emergency
[PatName Patient Name Unicode Character String

] （Optional）
[PatBarC Barcode （Optional） ASCII Character String

ode]
[PatBedC Bed code（Optional） ASCII Character String
ode]
[PatBirth] Patient Birth yyyyMMdd
（Optional）
[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]||[S
ampleTime]|[StartTime]||||||[Symptom]||[SanpleType]|[SendDOCName]||
[SendDP]<CR>

[SampleType] Sample Type 1 byte ASCII Character String
（Optional） 1Normal
2 Control 3 Calibration
[REQID] Request ID ASCII Character String
（Optional）
[SampleID] Sample ID ASCII Character String

[CompanyName] Company Name ASCII Character String
106
[InstrName] Instrument Name ASCII Character String

[SampleTime] Send Time yyyyMMddhhmmss
（Optional）
[StartTime] Start Test Time yyyyMMddhhmmss

（Optional）
[Symptom] Symptom Unicode Character String

（Optional）
[SampleType] Sample Type 1 byte ASCII Character String

（Optional） 1Normal
2 Control 3 Calibration
[SendDOCName] Send Doctor Unicode Character String
（Optional）
[SendDP] Send department ASCII Character String

ID（Optional）
For Example：
OBR|1|101009001|000001|URITÛT-1200||20101010093000|20101010093
500||||||Blood Urine||URI|Lisi||011
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>
[ValueType] Value Type NM is number，ST indicates text ED

means others.
[ItemID] Item ID ASCII Character String
[ItemName] Item Name Unicode Character String
（Optional）
[TestResult] Test Result SCII Character String

[Unit] Unit ASCII Character String
[ConsultValue] Reference SCII Character String
[Flag] Abnormal Result 1byte H is high N is normal L is

Flay low
107
[OD] Original Result ASCII Character String

（Optional）
[ItemResultTime] Item Result Send yyyyMMddhhmmss

Time（Optional）
[DocDP] Inspection Doctor

Department ID
（Optional）
[DOCName] Doctor’s Name

（Optional）
[Method] Test Method ASCII Character String

（Optional）
For Example
OBX|1|NM|001^WBC|WBC|0.4|ul|0.0-1.0|N|||F|||20101010094505|011|Wangw
u|
E.2.4.7 OBX Image Field Meaning
OBX|1|ED|[ItemID]|[ItemName]|[InstrID]Îmage^[FormartName]^Base64^
Qk02XgEAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA…||||||F|||[ ItemResu
ltTime]|[ DocDP]|[ DOCName]|

[ItemID] Item ID ASCII Character String
[ItemName] Item Name Unicode Character String
（Optional）
[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|UT1200Îmage^JPEG^Base64^Qk02XgEAAAAAAAAA
108
AAAAAAAAAAAAAAAAAAAAAAA||||||F|||20101010093515|011|Wangwu|
E.3 Integrated Example

E.3.1 Example
<SB>
MSH|^~\&|URIT|UT-1200|LIS|PC|20101010093505||ORU^R01|URIT-USA|
P|2.3.1||||||UNICODE
PID|2|1010051|A1123145|15|Zhangsan||19811011|M<CR>
OBR|1|101009001|000001|URITÛT-1200||20101010093000|2010101009350
0||||||Blood Urine||URI|Lisi||011<CR>
OBX|1|NM|001^WBC|WBC|0.4|ul|0.0-1.0|N|||F|||20101010094505|011|Wangw
u|<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|UT1200Îmage^JPEG^Base64^Qk02XgEAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAA||||||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 】
109
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-1320
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
110
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
111
Appendix F: List of attachments
Power cable 1
1
IPU host 1
2
Monitor 1
3
Keyboard and mouse suit 1
4
Eight 100M switch 1
5
3 m reticle 1
6
1.5 m reticle 1
7
3 M ground wire 1
8
External tube components 1
9
Waste container(20L hard container) 1
10
Bottle opener 1
11
Link block 1 1
12
13 Link block3 1
14 Urine analyzer tube rack( No. 11-20) 10

10ml Screw cap centrifuge tube 100
15
Operation Manual 1
16
Simple user manual 1
17
Urine sediment atlas 1
18
Product certificate 1
19
Service manual 1
20
Record chart of installation ,debugging and training 1
21 （in duplicate）
Form of the product installation and acceptance 1
22
23 Registration certificate 1
Maintenance record card cover 1
24
Maintenance record card for URIT products 1
25
Mouse pad 1
26
112
Appendix G:Toxic and Hazardous Substances or
Elements
Toxic and Hazardous Substances or Elements

Polybromi
Polybrominated
Parts Plumbum Mercury Cadmium Chromium nated
Diphenyl Ethers
（Pb）（Hg）（Cd） VI（Cr(VI)） Biphenyls
（PBDE）
(PBB)
Shell ○ ○ ○ ○ ○ ○
Printed
circuit ○ ○ ○ ○ ○ ○
board
Assembly
Sheet ○ ○ ○ ○ ○ ○
metal Parts
Plastic ○ ○ ○ ○ ○ ○
Host Parts
Machining ○ ○ ○ ○ ○ ○
parts
Hardware ○ ○ ○ ○ ○ ○
Flow
System ○ ○ ○ ○ ○ ○
Parts
Cable ○ ○ ○ ○ ○ ○
Accessories ○ ○ ○ ○ ○ ○
Packaging ○ ○ ○ ○ ○ ○
Materials
The table is compiled in accordance with SJ/T 11364.
○：The content of toxic or hazardous substance in the homogeneous materials of the parts above
is in the acceptable range of GB/T 26572.
×：The content of toxic or hazardous substance is exceed the acceptable range of GB/T 26572 in
at least one kind of homogeneous material of the parts above.
(The circuit board used lead solder in machining process and some parts of the board contain
plumb；And some sheet metal parts use chromium VI for surface ）
Memo：Printed circuit board Assembly is consist of printed circuit board, capacitance, connector
and other parts. Lithium cell is detachable and recyclable part.
113

UD-1320 user manual

Uploaded by

Copyright:

Available Formats

You might also like

UD-1320 user manual

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

UD-1320 user manual

Uploaded by

Copyright:

Available Formats

NOTE:

Copyright and Declaration .......................................................................................... i

Instructions for use

Harmonic current IEC 61000-3-2 Class A P

2, Immunity requirements for IVD medical equipment

AC power Voltage dip IEC 0 % during 1 cycle P

Surge IEC 1 kV(Line to line) / 2 P

Warning: Use of this instrument in a dry environment, especially if

URIT Medical Electronic Co., Ltd.

Address:No. D-07 Information Industry District, High-Tech Zone, Guilin,

Guangxi 541004, P. R. China

Shanghai International Holding Corp. GmbH (Europe)

01/2017-3 Appendix F was modified, and

the latest technical requirements, the

Version: 01/2017-3-C1. Compiled in January 2017, first revised in June 2018,

This user manual contains general information on the use of the

Denotes a hazard which, if not avoided, could

Denotes potential hazards that could result in

Denotes potential bio-hazard.

➢ The equipment meets the emission and anti-disturbance requirements

before the equipment is used.

UD-1320 automatic urine sediment analyzer (hereinafter referred to as

1.1.1. Product Principle

Adopting automatic recognition technology of digital imaging, planar flow

Optical system and digital camera constitutes digital imaging system. It

Intelligent recognition system can divide, identify and classify sediments.

Its highly optimized recognition algorithm guarantees accuracy of classification.

The measurement principle of the conductivity is mainly that the urine

Figure 1 Planar flow cytometry and digital imaging system

The analyzer consists of a microscopic imaging system, fluid system,

1.1.3. Measurement items

Red blood cell

Burry red blood

Red Blood Cell Coin red blood

Ghost red blood

5 White blood cell WBC

cells Renal tubular

7 Hyaline cast HYA 11 / /

12 Granular cast GRAN

13 Waxy cast WAXY

15 Mixed cast C-MIX

11 Struvite crystal Struvite 19 / /

15 Fungus Molds 26 Candida yeast Candida

Note：the test items are updated as the recognition system evolves.

2）Urine physical measurement items：

The analyzer can measure urine conductivity and osmotic pressure.

3）Body fluid measurement items：

The analyzer can be used to test cerebrospinal fluid, thoracoabdominal

Cerebrospinal fluid RBC, WBC

Thoracoabdominal fluid RBC, WBC

Gynecological secretions RBC, WBC, EP, BACT

4）RBC morphology test items

1.1.4.1. Detection limit

The detection limit of RBC and WBC should be 5 /μL.

1.1.4.2.1 Repeatability of sediment test

The coefficient of variation of test results should meet the requirements in

Table 1-1 Coefficient of variation（CV）

1.1.4.2.2 Repeatability of conductivity and osmotic pressure

The coefficient of variation of conductivity and osmotic pressure should