AVE AVE-73 Series User manual
AVE-73 Series Urine Analyzer
User’s Manual
AVE SCIENCE & TECHNOLOGY CO., LTD.
Building B6, Luguyuyuan, No.27 Wenxuan Road, Changsha Hi-tech Industrial Development Zone, Changsha,
Hunan 410205, P.R.China
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The information in this manual was correct at the time of printing.
However, AVE SCIENCE & TECHNOLOGY continues to improve its products and
reserves the right to change specifications, equipment, and maintenance procedures at
any time without notice.
Companies, names and data used in examples are fictitious unless otherwise noted. No
part of this document may be reproduced or transmitted in any form or by any means,
electronic, mechanical or otherwise, for any purpose, without the express written
permission of AVE. AVE may have patents or pending patent applications, trademarks,
copyrights or other intellectual or industrial property rights covering this document or
subject matter in this document. The furnishing of this document does not give a license to
these property rights except as expressly provided in any written license agreement from
AVE.
If this instrument is used in a manner differently than specified in this manual, the
protection provided by the equipment may be impaired.
Modification history
Version Date Modification
1.0 31.1.2021 First edition
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INDEX
1 PREFACE...........................................................................................................................1
1.1 Application Scope ............................................................................................................. 1
1.2 Product Classification ...................................................................................................... 1
1.3 How to Use User Manual................................................................................................ 1
1.4 Precaution Measures and Warning Symbols—Definitions................................. 2
1.4.1 Cautions.................................................................................................................... 2
1.4.2 Warnings................................................................................................................... 2
1.4.3 Biohazard Warning................................................................................................ 2
1.5 Symbols ................................................................................................................................ 3
1.6 Contact Information......................................................................................................... 4
1.7 Statement............................................................................................................................. 5
1.8 Warranty............................................................................................................................... 7
1.9 Limitation of Liability........................................................................................................ 8
1.10 Safety Instructions and Precautions......................................................................... 8
1.11 Intellectual Property....................................................................................................... 8
2 SYSTEM INSTRUCTION........................................................................................... 10
2.1 Working Principle............................................................................................................10
2.2 Performance and Technical Indicators ....................................................................11
2.2.1 Main Detected Parameters...............................................................................11
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2.2.2 Main Functions.....................................................................................................11
2.2.3 Perfomance Indicators.......................................................................................12
2.2.3.1 Testing Speed............................................................................................12
2.2.3.2 Repeatability..............................................................................................13
2.2.3.3 Accuracy......................................................................................................13
2.2.3.4 Stability........................................................................................................13
2.2.3.5 Carryover Contamination......................................................................13
2.3 System Structures............................................................................................................14
2.3.1 AVE-733A Urine Analyzer Host.......................................................................14
2.3.2 Data Analysis Processor ....................................................................................15
2.4 Software Function and Composition........................................................................16
2.4.1 Test Menu...............................................................................................................18
2.4.2 Inquiry Menu.........................................................................................................19
2.4.3 Setting Menu.........................................................................................................20
3 INSTALLATION............................................................................................................ 22
3.1 Summary ............................................................................................................................22
3.2 Installation Requirements ............................................................................................22
3.2.1 Space........................................................................................................................22
3.2.2 Power .......................................................................................................................22
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3.2.3 Environmental requirements ...........................................................................23
3.2.4 Installation requirement....................................................................................24
3.3 Packing list.........................................................................................................................24
3.4 Load Paper into Printer .................................................................................................25
3.5 Power cord connection .................................................................................................26
4 SETTINGS...................................................................................................................... 27
4.1 Instrument settings.........................................................................................................28
4.1.1 Parameter settings ..............................................................................................28
4.1.2 Factory information ............................................................................................29
4.1.3 Software upgrade................................................................................................30
4.2 Quality control settings.................................................................................................30
4.3 Report setting...................................................................................................................32
5 SAMPLE PROCESSING............................................................................................ 34
5.1 Power on ............................................................................................................................34
5.2 Sample Preparation ........................................................................................................34
5.2.1 Ambient temperature requirements.............................................................35
5.3 Urine chemistry strips preparation ...........................................................................35
5.4 Sample test........................................................................................................................36
5.5 Quality Control.................................................................................................................41
5.5.1 Control Frequency...............................................................................................41
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5.5.2 QC Parameters Input..........................................................................................41
5.5.3 Running QC ...........................................................................................................41
5.5.4 QC result.................................................................................................................42
5.5.4.1 QC test result.............................................................................................42
5.5.4.2 QC Inquiry ..................................................................................................42
5.5.5 Remedies on Out-of-control............................................................................44
5.6 Data inquiry.......................................................................................................................44
5.6.1 Patient data entry................................................................................................44
5.6.2 Print report ............................................................................................................45
5.6.3 Data inquiry...........................................................................................................45
5.7 Power off ............................................................................................................................47
6 MAINTENANCE AND SERVICE............................................................................. 50
6.1 Maintenance .....................................................................................................................50
6.1.1 Precautions ............................................................................................................50
6.1.2 Daily Maintenance...............................................................................................50
6.1.3 Periodic Maintenance.........................................................................................51
6.2 Daily Maintenance ..........................................................................................................51
6.2.1 Cleaning Instrument Surface...........................................................................51
6.2.2 Cleaning Waste Strip Box..................................................................................51
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6.3 Weekly Maintenance......................................................................................................53
6.3.1 Cleaning strip tray ...............................................................................................53
6.4 As Needed Maintenance ..............................................................................................54
6.4.1 Cleaning Photoelectric Sensors......................................................................54
6.4.2 Changing the Fuse ..............................................................................................54
6.5 Troubleshooting ..............................................................................................................55
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1 PREFACE
1.1 Application Scope
Used, with matched urine test strips, for semi-quantitative analysis of clinical
urine routine parameters by medical institutions.
1.2 Product Classification
AVE-73 series urine analyzers, based on Medical Devices Management
Category, belong to clinical detection and analysis analyzer and are Class II medical
devices.
Over-voltage category applied: Class II, pollution level: Class 2.
1.3 How to Use User Manual
AVE-73 series urine analyzers’eight models (including AVE-731A urine
analyzer, AVE-731B urine analyzer, AVE-731C urine analyzer, AVE-731D urine
analyzer, AVE-732A urine analyzer, AVE-732B urine analyzer, AVE-733A urine
analyzer and AVE-733B urine analyzer, hereafter called AVE-73 series urine
analyzers) only have the diffirence of product software control module. The
principles and the hardware structures are all the same. Therefore, this manual is
use AVE-733A urine analyzer as the reference to edit using instructions, completely
introduce performance and operation methods, it also can be used as training
instruction and trouble shooting by operator. Before using AVE-73 series urine
analyzer, please carefully read and understand its content to make sure use AVE-73
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series urine analyzer correctly, realize the best performace and gurantee the safety
of operator.
1.4 Precaution Measures and Warning
Symbols—Definitions
The manual include informations and warnings to which operator must pay
attention in order to make sure safe operation of software.
1.4.1 Cautions
CAUTION: Identifies situation that could lead to an accident or
equipment failure.
CAUTION: Identifies electrical caution! Unplug before handling.
1.4.2 Warnings
WARNING: Identifies potentially hazardous situation that could result
in serious injury to laboratory personnel.
1.4.3 Biohazard Warning
BIOHAZARD WARNING: Identifies potential biohazard. Please be
cautious when using , cleaning or maintaining the equipment and taking
proper protective measures.
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1.5 Symbols
The following is a list of symbols used on the nameplate, product packaging or
within the user manual and their corresponding meaning.
No. Symbol Description Location
1 Cautions User manual, nameplate
2 Cautions User manual, instrument
3 Warning User manual
4 Biological hazards
User manual, instrument,
nameplate
5
Earth terminal, the
terminal must be
connected firmly
Instrument
6 Power on User manual, instrument
7 Power off User manual, instrument
8 Date of manufacture
Nameplate, product
packaging
9
In vitro diagnostic
medical device
Nameplate
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No. Symbol Description Location
10 Manufacturer
Nameplate, product
packaging
11
Consult instructions for
use
Nameplate, product
packaging
12 Fragile Product packaging
13
Do not use when package
damaged
Product packaging
14 Stacking limits Product packaging
15 Ban rolling Product packaging
16 Upward Product packaging
17 Keep dry Product packaging
1.6 Contact Information
AVE SCIENCE & TECHNOLOGY CO., LTD.
Building B6, Luguyuyuan, No.27 Wenxuan Road
Changsha Hi-tech Industrial Development Zone,
Hunan 410205, P.R.China
Tel: +8 6-731-8892 5308
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Fax: +86-731-8890 7046
Website: http://www.c-ave.com/en.html
1.7 Statement
AVE Science & Technology Co., Ltd. (Hereafter called “AVE Science &
Tecnology”) reserves the final explanation to the manual. The product pictures and
product information involved in this manual are for reference only. Please refer to
the actual product in the end. The company reserves the right to modify the
manual and products, subject to change without notice
When all the following requirements are met, AVE Science & Technology
believes that it should be responsible for the safety, reliability and performance of
the product, namely:
a. The assembly operation, expansion, re-adjustment, improvement and repair
are all carried out by professionals approved by AVE Science & Technology;
b. All replaced spareparts involved in maintenance, supporting accessories and
consumables are the original ones from AVE Science & Technology or the ones
approved by AVE Science & Technology;
c. The relevant electrical equipment meets the national standards and the
requirements of this product manual;
d. The product operation is carried out in accordance with this product manual.
WARNING: This analyzer can only be operated and used by
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laboratory professionals, doctors and experimenters trained by AVE Science &
Technology or its distributors。
WARNING: If the hospitals or institutes carried the responsibility of
using analyzer don’t have a set of stasified repairmen or maintenance plan, it
may cause the unnormal analyzer failure and may endanger your health.
WARNING: Please make sure to use the analyzer under the use
conditions and protection measures required in the manual. If it is out of use
conditions and allowed risk levels, the analyzer may can’t run normally, the
testing results will not be reliable, and it may cause damage to the parts of
analyzer and endanger your health.
WARNING: If the moving parts will inevitably be exposed during
normal operation, the operator can operate the precudures only after they
have had enough trainings on the most safe way of these operating
procedures.
WARNIGN: If the instrument is not used, transported or handled, the
operator should abide by the laboratory safety operation regulations and wear
personal protective equipment (such as laboratory protective clothing , gloves,
etc.
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1.8 Warranty
AVE Science & Technology provides lifetime maintenance service for its
products sold by the authorized distributors or agents. For failures caused by
product quality problems under normal use conditions, AVE Science & Technology
will provide a 24-month warranty period, or replace them according to the
company's specific provisions on service commitments. During the 24-month
warranty period, maintenance service fees and accessory fees are waived; after the
warranty period, related expenses incurred will be charged according to relevant
standards.
In one of the following situations, you do not enjoy free warranty service:
a. Damages and failures caused by natural disasters and accidents (such as fire,
earthquake, lightning strike);
b. Failure caused by not operating as required, using in unacceptable working
environment and conditions (including unstable voltage of local power system, and
failure to select a good quality regulator, etc.);
c. Damage casued by the product repaired and its additional parts replaced
by persons not authorized by AVE Science & Technology;
d. The warranty does not include outer shell, accessories, consumables (such as
printing paper, etc.);
e. Damage caused by improper transportation after delivery (such as:
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appearance damage, components falling off due to shock);
f. Computer failures caused by deleting or moving computer content or loading
other software, etc.;
g. Failure to provide a valid warranty certificate or the content of the certificate
is inconsistent with the product or has been altered.
1.9 Limitation of Liability
The company is not responsible for any loss of use, income or expected profit,
nor is it responsible for any indirect or incidental damage caused by the sale or use
of this product.
1.10 Safety Instructions and Precautions
In order to minimize the failure of the instrument, the user is subject to the
following requirements.
a. The product instrument should be used by authorized personnel, and it is
forbidden to use it by others.
b. Establish good usage habits and do not insert mobile storage devices from
unknown sources that are not disinfected.
c. The upgrade of product software should be done by authorized
professionals.
1.11 Intellectual Property
The intellectual property rights of this product manual and its corresponding
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products belong to AVE Science & Technology.
Copyright: Without the written consent of AVE Science & Technology, no
individual or organization may copy, modify or translate any part of this manual.
Disclaimer: AVE Science & Technology has the final right to interpret this
product manual.
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2 SYSTEM INSTRUCTION
2.1 Working Principle
After placing urine test strip impregnated with urine sample on the test strip
holder as required, the transmission device of the instrument will transport urine
test strip directly under the detector, turn on the light source, and automatically
scan the reflected light of each test pad of urine test strip, which has finished
chemical reaction, by the detection device. Each test pad of urine test strip reacts
independently with the corresponding components in the urine, displaying
different colors, and the color depth is proportional to the concentration of the
components in the urine. The darker the color of each test pad after reaction, the
greater the value of absorbed light, and the smaller the value of reflected light, the
smaller the reflectivity. On the contrary, the lighter the color, the smaller the value
of absorbed light, and the greater the value of reflected light, the greater the
reflectivity. According to the principle of photoelectric colorimetry, the color
change produced by the reaction between the color pad of urine test strip and the
components in the urine is used to determine the concentration of each test items
in the urine (Bilirubin, Protein, Urobilinogen, Glucose, Ketones, Blood, Nitrite, PH,
Specific Gravity, Leukocytes, Ascorbic Acid, Creatinine, Calcium, Microalbumin,
etc.). Through software processing to determine the results of chemical test items,
and finally form a complete test report.
Urine analyzer is equipped with a blank board as a random standard to
correct the errors of the instrument's light source and sensor. The measured light
value of each test strip's reflected light is divided by the light value of the blank
board's reflected light to obtain the reflectance. The content of biochemical
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components in urine is determined based on reflectance.
The calculation formula of reflectance is as follows:
=
× Cs
× Cm
×100%
In the formula:
R —— Reflectivity
—— The reflection intensity of urine test strip measuring wavelength
Cs—— The reflection intensity of the blank board measuring wavelength
during the production of the instrument
—— The reflection intensity of the blank board measuring wavelength
during the test
Cm—— The reflection intensity of the white standard measuring wavelength
during the production of the instrument.
2.2 Performance and Technical Indicators
2.2.1 Main Detected Parameters
Bilirubin (BIL), Protein (PRO), Urobilinogen (URO), Glucose (GLU),
Ketones(KET), Blood (BLD), Nitrite (NIT), PH, Specific Gravity (SG), Leukocytes
(LEU), Ascorbic Acid (VC), Creatinine (CRE), Calcium (Ca), Microalbumin (MCA),
etc. The specific items are determined by the matched urine test strips.
2.2.2 Main Functions
Power-on self-checking: The analyzer can self-checking after power-on, identify
faults and report error messages.
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Reporting function: Report results include the plus sign system, common unit
system and international unit system.
Data recording function: The analyzer has the function of storing and querying test
results, and the data can still be saved after power failure.
Input function: The analyzer is equipped with buttons or touch screen, and can
input relevant information with LCD display.
Printing function: The result can be output through the built-in thermal printer; it
can be displayed through the LCD.
Data transmission function: The result can be output through the network port; it
can also be uploaded to the host computer through the serial port, so as to connect
with the hospital management system or to further analyze the test results.
Software upgrade: Through USB, serial port and special software, the analyzer
software can be easily updated and upgraded.
Alarm function: With fault alarm function.
2.2.3 Perfomance Indicators
2.2.3.1 Testing Speed
Analyzer Model Test Speed
AVE-731A
120 tests/hour
AVE-731B
AVE-731C
AVE-731D
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AVE-732A
300 tests/hour
AVE-732B
AVE-733A
514 tests/hour
AVE-733B
2.2.3.2 Repeatability
The coefficient of variation (CV,%) of the reflectance test result of the analyzer
is ≤1%.
2.2.3.3 Accuracy
The difference between the test result and the label value of the corresponding
reference solution shall not exceed one order of magnitude in the same
direction, and there shall be no reverse difference, the positive reference
solution shall not have a negative result, and the negative reference solution
shall not have a positive result.
2.2.3.4 Stability
Within 8 hours of starting the analyzer, the coefficient of variation (CV, %) of
the reflectance test results is ≤1%.
2.2.3.5 Carryover Contamination
Test the positive sample with the highest concentration of each item except the
specific gravity and PH, and then test the negative sample. The negative sample
shall not be positive.
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