Avantor A9 PDF

A9 HbA1c Analyser
User Manual
IVD
Avantor Performance Materials

Intellectual Property
Avantor Performance Materials (hereinafter “Avantor”) has the copyright of this

manual not publicly published the right to treat it as confidential materials. This
manual is merely a reference for the operation, maintenance and service of Avantor’s
products. This manual and all intellectual properties (including copyright) pertaining
to it shall reside with Avantor. Without the prior written permission of Avantor, no
person shall use, disclose or allow others to obtain this manual by any means in whole
or in part, and no one shall photograph, copy, duplicate or translate (without limitation
to the foregoing) this manual in whole or in part.
Avantor has the right of final interpretation of this Manual.
Avantor reserves the right to update product technology without prior notice;
Avantor reserves the right to modify product specifications without prior notice.
Avantor reserves the right to modify the manual without prior notice.
Statement
Avantor makes no guarantee for this document whatsoever, including (but not limited
to) implied merchantability and suitability for a particular purpose.
Avantor shall be responsible for the safety, reliability and performance of its product
only when:
The assembling, expansion, readjustment, improvement and repair are carried out
by Avantor authorized personnel;
The machine is used according to operation instructions;
Electrical devices are in compliance with national standards.
Avantor shall not be responsible for the safety, reliability and performance of its
product if:
The product has reached its lifetime limit;

Parts have been disassembled, stretched or readjusted;
The machine is not used properly according to User Manual.
I
Warranty
Repair Service
Scope of free service:
Product is entitled to free service if it is within Avantor warranty provisions.
Scope of fee-based service:
(1) Avantor will provide fee-based service if the product is not within the range of
Avantor’s warranty provisions;
(2) Within warranty period, fee-based service will be provided if the product defect is
caused by:
Misuse;
Man-made damage
Replacement with parts not approved by Avantor;
Repair of the machine by personnel not authorized by Avantor;
Grid voltage beyond equipment specifications;
Uncontrollable natural disasters.
Avantor shall not be responsible for direct, indirect or consequential damage or delay
caused by the foregoing (including but not limited).
II
Return of Product
(1) Obtain Return Material Authorization. Contact Avantor’s Customer Service Dept.
and provide the S/N of Avantor product. The S/N is marked on the package. Return of
product will not be accepted if the S/N is not clearly legible. Please note the type, S/N
of product and reason of return.
(2) Freight expense: Freight (including customs fees) of products returned to Avantor
for service shall be borne by the customer.
Contact
Avantor Performance Materials India Limited Headquarters

17th Floor, Building No. 5 Tower C
DLF Cyber City Phase - III
Gurgaon - 122002, Haryana
India
0091-129-4267000
Fax: 0091-129-4267299
III
● The system is operated and used by Avantor or designated agents trained
professionals, doctor or lab assistant;
● If hospitals or institutions can not achieve a satisfactory repair / maintenance plan,
it may cause abnormal instrument failure, and may endanger human health.
● Ensure to run the instrument under the conditions that are written in this manual.
If not, it may fail to run, result in inaccurate results, or even damage the
components and injure humans.
This manual is for and only for:
1. Daily operations personnel

2. System maintenance and troubleshooting personnel
3. Personnel that learn to use the system
IV
Content
Contact.............................................................................................................................................III
Chapter-1 Manual Brief Description......................................................................................................... 1
1.1Breif Introduction....................................................................................................................... 1
1.2 Scope of the Manual.................................................................................................................. 1
1.3 Content of the Manual........................................................................................................2
1.4 Declaration................................................................................................................................. 2
1.5 Symbols and Labels................................................................................................................... 3
Chapter 2 General Description.................................................................................................................. 1
2.1 Test Parameters......................................................................................................................... 1
2.2 Product Description...................................................................................................................2
2.2.1 LCD touch Screen.......................................................................................................................6
2.2.2 Thermal Printer.......................................................................................................................... 6
2.2.3 Computer Interface.................................................................................................................... 6
2.2.4 Bar Code Scanner Interface.......................................................................................................6
2.2.5 Printer Indicator and PF button............................................................................................... 6
2.2.6 Power Input Socket.....................................................................................................................6
2.2.7 Keypad......................................................................................................................................... 6
2.3 Operation Interface................................................................................................................... 8
2.3.1 Menu............................................................................................................................................ 8
2.3.2 Function Brief Introduction.......................................................................................................8
2.4 Reagent, column, pretreatment column, QC material and calibrator................................. 9
2.4.1Reagent......................................................................................................................................... 9
1
2.4.2 Chromatographic Column....................................................................................................... 10
2.4.3 Pretreatment Column...............................................................................................................10
2.4.4 QC Material and Calibrator....................................................................................................10
Chapter 3 Working Principle..................................................................................................................... 1
3.1 Aspirate Sample......................................................................................................................... 2
3.2 Measurement..............................................................................................................................2
3.2.1 Ion Exchange Theory..................................................................................................................2
3.2.2 Colorimetric Analysis Principle................................................................................................ 3
3.3 Resin Balance and System Rinse.............................................................................................. 5
Chapter 4 Installation.................................................................................................................................1
4.1 Installation Requirements.........................................................................................................2
4.1.1 Environment Conditions............................................................................................................ 2
4.1.2 Space............................................................................................................................................ 2
4.1.3 Power Supply...............................................................................................................................2
4.2 Open Package.............................................................................................................................3
4.2.1 Opening Steps..............................................................................................................................3
4.2.2 Move the Analyser...................................................................................................................... 3
4.3 Installation Procedure............................................................................................................... 4
4.3.1 Cut the Cable Ties.......................................................................................................................4
4.3.2 Reagent Connection....................................................................................................................6
4.3.3 Waste Bottle.................................................................................................................................7
4.3.4 Column and Pretreatment Column Installation...................................................................... 7
4.3.5 Thermal Paper Installation......................................................................................................10
2
4.3.6 Bar Code Scanner Connection................................................................................................ 10
4.3.7 Power Adapter Connection......................................................................................................11
4.4 Start-up for the First Time..................................................................................................... 11
Chapter 5 Parameter Settings.....................................................................................................................1
5.1 Printer Settings.......................................................................................................................... 2
5.2 Date and Time............................................................................................................................ 2
5.3 Auto QC...................................................................................................................................... 3
Chapter 6 Daily Operation.........................................................................................................................1
6.1 Check before Operation............................................................................................................ 2
6.2 Preparation before Operation.................................................................................................. 3
6.3 Daily QC..................................................................................................................................... 3
6.4 Preparation for Sample............................................................................................................. 4
6.4.1 Whole Blood Sample...................................................................................................................5
6.4.2 Prediluted Sample.......................................................................................................................5
6.5 Assay Whole Blood Sample.......................................................................................................6
6.5.1 Load Sample Information.......................................................................................................... 6
6.5.2 Set Start Position and End Position.......................................................................................... 7
6.5.3 Cancel Current Sample Information Input..............................................................................7
6.5.4 Cancel All Sample Information Input...................................................................................... 7
6.5.5 Sample Test................................................................................................................................. 7
6.5.6 Emergency Stop.......................................................................................................................... 9
6.5.7Add Sample During Testing........................................................................................................9
6.5.8 Emergency Sample Loading...................................................................................................... 9
3
6.6 Assay Prediluted Sample.........................................................................................................10
6.6.1 Load Sample Information........................................................................................................ 10
6.6.2 Set Start Position and End Position........................................................................................ 11
6.6.3 Sample Test............................................................................................................................... 11
6.6.4 Emergency Stop........................................................................................................................ 12
6.6.5 Add Sample During Testing.................................................................................................... 12
6.7 Power Off..................................................................................................................................13
Chapter 7 Data Query................................................................................................................................ 1
7.1 Data Exploration........................................................................................................................2
7.2 Delete Data..................................................................................................................................2
7.3 Print Result.................................................................................................................................4
Chapter 8 Quality Control..........................................................................................................................1
8.1QC Material Information Input................................................................................................ 2
8.2 Auto QC...................................................................................................................................... 3
8.3 Start QC......................................................................................................................................4
8.4 QC Statistics............................................................................................................................... 5
8.5 QC Curve....................................................................................................................................7
Chapter 9 Calibration.................................................................................................................................1
9.1 Calibration Frequency.............................................................................................................. 2
9.2 Calibration Method................................................................................................................... 2
9.3 Calibrator Information Input...................................................................................................3
9.4 Start Calibration........................................................................................................................ 4
9.5 Manual Calibration................................................................................................................... 7
4
9.6 Calibration Query......................................................................................................................8
Chapter 10 Service.....................................................................................................................................1
10.1 Maintenance Guide..................................................................................................................2
10.2 Daily Service.............................................................................................................................2
10.2.1 Column Information.................................................................................................................3
10.2.2 Pretreatment Information........................................................................................................3
10.2.3 RFID Card.................................................................................................................................4
10.2.4 Temperature of Mixing Cup....................................................................................................4
10.2.5 Temperature of Column...........................................................................................................4
10.2.6 Environment Temperature...................................................................................................... 4
10.2.7 LED Value................................................................................................................................. 4
10.2.8 Potential Detection....................................................................................................................4
10.3 System Maintenance................................................................................................................ 5
10.3.1 Prime A Eluent..........................................................................................................................5
10.3.2 Prime B Eluent.......................................................................................................................... 5
10.3.3 Prime C Eluent..........................................................................................................................5
10.3.4 Prime Hemolytic Agent............................................................................................................ 6
10.3.5 Liquid Line Rinse......................................................................................................................6
10.3.6 Drain Liquid Line..................................................................................................................... 6
10.3.7 Liquid Line Counter-rinse....................................................................................................... 6
10.3.8 Bubble Elimination................................................................................................................... 6
10.3.9 Priming...................................................................................................................................... 7
10.3.9 Mixing Cup Wash..................................................................................................................... 7
5
10.3.10 Motor Reset............................................................................................................................. 7
10.3.11 Printer Test..............................................................................................................................7
10.4Help............................................................................................................................................ 7
10.4.1 Working Principle.....................................................................................................................8
10.4.2 How to Replace Thermal Print Paper.....................................................................................9
10.4.3 Contact Us................................................................................................................................. 9
10.4.4 How to Install Pretreatment Column....................................................................................10
10.4.5 How to Install Column........................................................................................................... 11
10.4.6 How to Replace Peristaltic Pump Pipe................................................................................. 12
10.4.7 How to Judge the Liquid Line is Blocked.............................................................................13
10.4.8 How to Deal with Leakage..................................................................................................... 14
10.4.9 When to Eliminate Bubbles................................................................................................... 14
Chapter 11 Troubleshooting................................................................................................................... 1
11.1 Faults and Troubleshooting.................................................................................................... 2
11.2 System Checkout Information and Troubleshooting........................................................... 3
11.3 Optical System Faults and Troubleshooting......................................................................... 3
11.4 Temperature Fault and Troubleshooting.............................................................................. 4
11.5 Outer Connection Fault and Troubleshooting......................................................................4
11.6 Faults of Reagents, Column or Pretreatment Column and Troubleshooting.................... 5
Appendix A Specification..........................................................................................................................1
A.1 Product Classification...............................................................................................................1
A.2 Reagent Kit................................................................................................................................ 1
A.3 Column, Pretreatment Column and Peristaltic Pump Pipe..................................................1
6
A.4 QC Material...............................................................................................................................1
A.5 Calibrator.................................................................................................................................. 1
A.6 Power Input............................................................................................................................... 1
A.7 Working Environment..............................................................................................................1
A.8 Storage Temperature................................................................................................................2
A.9 Dimensions.................................................................................................................................2
A.10 Weight...................................................................................................................................... 2
A.11 Life Span.................................................................................................................................. 2
A.12 Print Report.............................................................................................................................3
Appendix B Safety Information.................................................................................................................1
B.1 Brief Description....................................................................................................................... 1
B.2 Warning..................................................................................................................................... 2
B.3 Caution....................................................................................................................................... 3
B.3 Note.............................................................................................................................................4
B.4 Bio-Hazard.................................................................................................................................6
Appendix C Communication..................................................................................................................... 1
C.1 RS232 Communication Parameters........................................................................................ 1
C.2 Communications Instructions..................................................................................................1
C.3 Sample Data Format.................................................................................................................2
C.4 QC Data Format....................................................................................................................... 3
C.5 Calibration Date Format..........................................................................................................4
7
Chapter-1 Manual Brief Description
1.1Breif Introduction
The chapter introduces how to use the A9 user manual. The user manual is
attached with mainframe and describes intend use, function and operation of A9
HbA1c Analyser in detail. Before use, read the user manual carefully, to ensure
rightful use and safety.
● Please strictly follow the instructions in the manual when operating
1.2 Scope of the Manual
This guide is intended for medical laboratory professionals, trained doctor,

nurse or lab assistant. Applicable for:
To learn the software and hardware about A9

Daily operation
System parameter settings
System maintenance and troubleshooting
1-1
1.3 Content of the Manual

The manual includes 11 chapters and 4 appendixes. The brief information of every
chapter shows below.
Chapter Description
Chapter 1 Manual Brief Brief description and framework of the manual

Description
Chapter 2 General Description Intend use, basic parameters, structures and operation interface of A9
Chapter 3 Working Principle Measuring principle and operation flow of A9
Chapter 4 Installation Installation requirements and steps of A9
Chapter 5 Parameter Settings Set system parameters like date, printer etc
Chapter 6 Daily Operation Operation steps of A9
Chapter 7 Data Query Sample result data query
Chapter 8 Quality Control QC Requirements and method of A9
Chapter 9 Calibration Calibration requirements and method of A9
Chapter 10 Service Maintenance and test method of A9
Chapter 11 Troubleshooting Failure cause and troubleshooting of A9
Appendix A Specification Specification , performance index and input/output devices of A9
Appendix B Security Security information

Information
Appendix C Communication Communication Protocol

Protocol
1.4 Declaration
All the charts and pictures in the manual are only for demonstration. Do not use it for other
purpose. And the chart, data might not be entirely consistent with real status.
1-2
1.5 Symbols and Labels
Symbols and labels in this manual
Meanings
Remind operator to follow the steps under this symbols,
otherwise it will result in personal injury
otherwise it will result in product failure, damage and inaccurate
results.
emphasize important/critical information or steps in the manual
otherwise it has bio-infectious risk.
Symbols and labels on the analyser, reagent, calibrators and QC materials
Meanings
Attention! Please refer to the manual!
the international symbol for biohazardous material
In Vitro Diagnosis
Lot number
Serial number
Expiration date
Manufacture date
Manufacturer
1-3
Storage temperature
Refer to the manual
Swipe the card
Computer interface
Computer Interface
Bar code scanner interface

Scanner Interface
A Eluent
A Eluent
B Eluent
B Eluent
C Eluent
C Eluent
Hemolytic agent
Hemolytic Agent
Waste liquid
Waste Liquid
Input voltage
DC+24V
Switch
ON/OFF
Waste electrical and electronic equipment
Keep away from rain
1-4
Fragile items
This way up
Grounding
Sticking limit by number
1-5
Chapter 2 General Description
2.1 Test Parameters
● A9 Analyser is a diagnosis device that is used for disease screening. When

diagnosing disease, clinicians should take clinical examination results or other test
result into consideration.
A9 Analyser adopts Liquid Chromatography to measuring the content of HbA1c in human

blood.
The A9 Analyser could display as much as 6 types of blood parameters and 1 type of
chromatogram result.
Item Unit Reference Standard
HbA1a+HbA1b Area% NGSP

HbA1c Area% NGSP
HbA0 Area% NGSP
HbA1c mmol/mol IFCC
Average Blood Glucose (eAG) mmol/l ADA
Average Blood Glucose (eAG) mg/dl ADA
Chromatogram — —
2-1
2.2 Product Description
②
⑥
③
⑤
④
Picture 2-1 Front View
① ---- Display Screen ② ---- Swiping Area

③ ---- Printer Indicator and PF Button ④ ---- Printer
⑤ ---- Sample Loader ⑥ ---- Sample Probe
2-2
⑳ ⑲ ⑱ ⑰ ⑯
⑮
⑭
①
⑬
⑫
②
⑪
③ ⑩
⑨
④
⑤ ⑥ ⑦ ⑧
Picture 2-2 Rear View
①---- 2D Injecting Arm ② ---- Mixing Cup

③ ---- Solenoid Valve 3 ④ ---- Injecting Pump
⑤ ---- Solenoid Valve 9 ⑥ ---- Solenoid Valve 8
⑦ ---- Solenoid Valve 7 ⑧ ---- Solenoid Valve 6
⑨ ---- Waste Liquid Line Connector ⑩ ---- Power Input Socket
⑪---- RS-232 Interface ⑫ ---- Scanner Interface
⑬ ---- Power Switch ⑭ ---- Plunger Pump
⑮ ---- Solenoid Valve 2 ⑯ ---- A Eluent Liquid Line Connector
⑰ ---- B Eluent Liquid Line Connector ⑱ ---- C Eluent Liquid Line Connector
⑲ ---- Hemolytic Agent Liquid Line Connector ⑳ ---- Solenoid Valve 1
2-3
⑦
⑥
①
⑤
②
③
④
Picture 2-3 Right Side View
① ---- Mixing Cup Heating Module ② ---- Mixing Cup Temperature Sensor
③ ---- Injecting Pump Cover ④ ---- Injecting Pump Spring
⑤ ---- Sample Probe ⑥ ---- Swap
⑦ ---- 2D Injecting Arm
2-4
①
②
③
④
⑤
⑥
⑦
⑧
⑨ ⑩ ⑪ ⑫
Picture 2-4 Left Side View
① ---- Plunger Pump ② ---- Chromatographic Column

③ ---- Column thermostat ④ ---- Column Module Temperature Sensor
⑤ ---- Photoelectric Detection Module ⑥ ---- Cuvette Fixing Leg
⑦ ---- Cuvette ⑧ ---- Waste Liquid Pump Cover
⑨ ---- Waste Liquid Pump Spring ⑩ ---- Peristaltic Pump Tube Connector
⑪---- Solenoid Valve 5 ⑫---- Solenoid Valve 4
2-5
2.2.1 LCD touch Screen
LCD touch screen is on the front side of A9 Analyser, see in picture 2-1, used for information
input and most operations.
2.2.2 Thermal Printer
Thermal Printer is on the front side of A9 Analyser, see in picture 2-1, used for print results
and other information
2.2.3 Computer Interface
RS-232 interface, for communicating with outer computers
2.2.4 Bar Code Scanner Interface
Bar code scanner interface, for communicate with scanner
2.2.5 Printer Indicator and PF button
Printer indicator indicates the status of paper consumption. Steady light indicates sufficient
paper. Flash light indicates insufficient paper.
2.2.6 Power Input Socket
Input voltage is DC+24v. Input power is 150VA
2.2.7 Keypad
There are two kinds of touch key pad for information input – numeric keypad and
comprehensive keypad, see in the below.
2-6
Picture 2-5 Numeric Keypad
Picture 2-6 Comprehensive Keypad
2-7
2.3 Operation Interface
2.3.1 Menu
After start-up process, it’s menu interface, see in picture 2-7. Press the functional areas to
enter corresponding interface.
Picture 2-7 Menu Interface
2.3.2 Function Brief Introduction
Table 2-1 Function Correspondence Table
Function Area Function

Test Load sample information, set sample loader starting and ending positions and
start testing
Query Query sample results, delete and print the results
QC Set the parameters of QC materials and start QC
Calibration Set calibrator parameters and start calibration
2-8
Settings Set time and printer
Power Off Shut down A9
2.4 Reagent, column, pretreatment column, QC material and
calibrator
Analyser, reagent, column, pretreatment column, QC material and calibrator form a complete
system, which should be used as a whole to ensure the performance of the system. Operators
should use reagent kits designated by Avantor (See specification in Appendix A). Otherwise, A9
Analyser may not be able to reach the performance level described in this manual. Use of
non-specified reagent kits will not guarantee reliable results. All the “reagent” in the manual
means the reagents designated by Avantor.
Check reagent package before use – the damage of package may affect the quality of reagents.
If there are damages, DO NOT use the reagent!
● Refer to the user manual of reagent to see how to use and store reagent
● After replace eluent, column, pretreatment column or hemolytic agent, the operator should rinse
the system to ensure ADC value in normal range
● Ensure use reagents, column and pretreatment column before expiration date
● Stand the reagents before use, to make it stable
2.4.1Reagent
A Eluent
Used to elute HbA1a and HbA1b (Hereinafter refer to as HbA1ab) those are less positively charged
B Eluent
Used to elute HbA1c that is well positively charged
C Eluent
Used to elute HbA0 that is most positively charged
2-9
Hemolytic Agent
Used to lyse erythrocytes and release glycosylated hemoglobin
2.4.2 Chromatographic Column
Chromatographic column contains cation exchange resin to adsorb glycosylated hemoglobin.

With increase of eluent concentration, HbA1ab, HbA1c, HbA0 will be eluted respectively.
Remark: Column specifically refers to chromatographic column in this manual, except as otherwise
noted.
2.4.3 Pretreatment Column
Pretreatment column contains sieve plate and a small quantity of cation exchange resin, to
filter impurities in liquid line and LHBs in blood. Keep the column from blocking, which will
slow down flow rate and increase pressure, to ensure system stable and reliable.
2.4.4 QC Material and Calibrator
QC material and calibrator are used for QC and calibration of A9. QC material is a type of
whole blood product, applied to test elution function of A9, including high level QC material and
low level QC material. Running QC program every day can detect the status of A9 and ensure
testing results reliable. Calibrator is also a type of whole blood product. Refer to the user manuals
of QC material and calibrator for the usage and storage method.
All the “QC material” and “calibrator” mentioned in this manual means the specific QC
material and calibrator designated by Avantor. Users needs to purchase from Avantor or
authorized distributors.
2-10
Chapter 3 Working Principle
In human blood, there are three kinds of hemoglobin (Hb): hemoglobin A (HbA),
hemoglobin A2 (HbA2) and hemoglobin F (HbF).
For adult, the level of HbA consists 97% of total hemoglobin. And HbA includes 2
subfractions: glycosylated hemoglobin (HbA1)(6%), un-glycosylated hemoglobin (HbA0)(94%).
Glycosylated hemoglobin is a compound that is formed in the non-enzymatic reaction
between hemoglobin and carbohydrate. Glycosylated hemoglobin is called HbA1c and
un-glycosylated hemoglobin is called HbA0.On the basis of combination with different
carbohydrate compound, glycosylated hemoglobin is divided into HbA1a1、HbA1a2、HbA1b and
HbA1c. Among of which, HbA1c is about 80% of HbA1, a stable addition compound formed by
one or two strips of β-chain amino terminal and glucose carbonyl.
See constituent of hemoglobin below.
Picture 3-1 Constituent of Hemoglobin
Synthesis process of HbA1c is slow and irreversible. And it accumulates in the 120 days
lifetime of erythrocytes. The synthesis rate is proportional to the concentration of blood glucose
and its structure is stabile. Therefore, the level of HbA1c reflects the average level of blood
glucose in the past 2-3 months. As the average amount of blood glucose increases, the fraction of
glycated hemoglobin increases in a predictable way, which is not related to blood drawing time,
whether it is fast or not and whether use insulin or not. It’s a reliable marker to indicate the control
of blood glucose levels.
A9 Analyser adopts Liquid Chromatography and Colorimetric Analysis method to measure
the level of HbA1ab, HbA1c and HbA0. And the analyser calculates the rest items.
3-1
3.1 Aspirate Sample
There are two methods to load sample – venous whole blood sample loading method and
diluted blood sample loading method.
Aspirate 10 µL whole blood sample when using venous whole blood sample loading method.
When using diluted blood sample loading method, the operator should mix 20 µL peripheral
blood sample and 500 µL deionized water first, to make a 1:25 diluted sample, then place the
diluted blood sample onto the sample loader. The analyser will aspirate 100 µL sample.
3.2 Measurement
3.2.1 Ion Exchange Theory
The glycosylation of hemoglobin will lose cation on hemoglobin surface. The ion
concentration increases and (or) PH decreases in low level cation-exchanger. When passing
through cation-exchange column, the hemoglobin will be absorbed by resin which was balanced
by acidic buffer. Since the charges of different glycosylated hemoglobin and un-glycosylated
hemoglobin, absorbing forces will be different. The less cation of glycosylated hemoglobin means
the less absorbing force. On the contrary, the cation level of un-glycosylated hemoglobin is high.
Elute those glycosylated hemoglobin with different buffer solutions in sequence, as HbA1a,
HbA1b, HbA1c. The strongest absorbing force of HbA0 will be eluted in the end. See the whole
elution process below.
Picture 3-2 Elution Process of Glycosylated Hemoglobin
3-2
3.2.2 Colorimetric Analysis Principle
According to Beer–Lambert law, when a collimated monochromatic light transit a even

solution medium, part of this light will be absorbed and the other part will be reflected by
container. Define the incident light intensity as I0, the transmission light intensity as It, the solution
concentration as c, and the thickness of liquid as b. See the absorbing schematic diagram below.
Picture 3-3 Absorbing Schematic Diagram
Written as：
I0
A = kbc= lg
It
In the equation above, A means absorbance; K is absorption coefficient. The equation means
that the absorbance of solution is in direct proportion to the product of solution concentration and
liquid thickness.
The absorption peak wavelength of glycosylated hemoglobin is 415nm. So when 415 nm
LED light transmit a cuvette, it will be absorbed by photocell after passing through a 415nm band
pass filter. Light intensity is proportion to the converted potential. See the schematic diagram
below.
Picture 3-4 Colorimetric Analysis Principle
Therefore, absorbance could be also written as:
I0 E0
A = lg = lg
It Et
In the equation above，E0 means incident light potential; Et means transmission light
potential.
Through amplifying and acquiring photocell signal by computer, measure real-time
3-3
absorbance of the eluates continuously. It will form a hemoglobin chromatogram, shown as below
Picture 3-5 Hemoglobin Chromatogram
Calculate the absorbance areas of HbA1ab, HbA1c and HbA0. The level of HbA1c is the
percentage the peak area of HbA1c of total area of the chromatogram. By that analogy, get levels
of HbA1ab and HbA0.
HbA1ab(%)=
∫A HbA1 ab
*100%
∫ AHbA1ab +∫A HbA1c + ∫ AHbA 0
HbA1c(%)=
∫A HbA1c
*100%
∫A HbA1ab +∫A HbA1c + ∫ AHbA0
HbA0(%)=
∫A HbA 0
*100%
∫ AHbA1ab +∫A HbA1c + ∫ AHbA 0
Remark: ∫A HbA1 ab is the absorbance integral area of HbA1ab
∫A HbA1c is the absorbance integral area of HbA1c
∫A HbA 0 is the absorbance integral area of HbA0
3-4
3.3 Resin Balance and System Rinse
During the elution process of the former sample, the system rinses sample probe and mixing
cup automatically. And then, the system will complete the whole process of the latter sample,
loading, hemolysis, mixing and sample probe rinse. After a complete rinse cycle, the system will
balance the column to prepare for next sample.
3-5
Chapter 4 Installation
The chapter introduces installation procedure and considerations.

To make sure the analyser function normally, installation at the time of delivery and
initializer setting ought to be conducted by authorized personnel.
● It might damage the device to unpack and install without authorized or trained personnel. So do not
unpack or install the device without present of one authorized or trained personnel.
4-1
4.1 Installation Requirements
The operator must ensure to meet the following environment, space and power requirements
before installation.
4.1.1 Environment Conditions
Temperature: 10 °C～35 °C
Humidity：≦70%
Air Pressure：75 kPa～106 kPa

Dust-free, no mechanical vibration, no noisy source and power interference
Evaluate the magnetic environment of laboratory before running the device
DO NOT let the device close to strong electromagnetic interference source, in case of
malfunction or the inaccuracy of data
DO NOT get close to brush-type motors, fluorescent flashing lights and frequent switch
electrical contact device
Avoid direct sunlight or putting in front of heat source or wild source
Maintain good ventilation
● DO NOT operate in flammable and explosive environment
● If room temperature exceeds normal operating temperature range, the obtained results will be
inaccurate
4.1.2 Space
To keep enough space for maintenance, troubleshooting, heat dissipation and liquid line
flowing normally, the installation space should be:
4-2
Distance of left/right side from the wall ≥ 50 cm
Distance of rear side from the wall ≥ 50 cm
4.1.3 Power Supply
Voltage：a.c.100～240V；
Frequency：50/60 Hz；
Input Power：150VA
● The analyser must be used in a good grounding condition

● Make sure input voltage meet the requirements.
● Make sure the switch is off (“○”) before connecting power cord of adapter
4.2 Open Package
4.2.1 Opening Steps
In order to avoid striking while transportation, the analyser has been strictly inspected before
dispatched from factory, and been packaged cautiously. Therefore, check the package carefully for
damage before opening. If it appears, please inform service department of Avantor or local
distributor of that.
Follow the steps below to remove the package if there is not any damage.
Put the box uprightly and make sure the arrow on the box is upward.
Remove the packing taper and check all the accessories referring to packing list. If anything
is missing, please inform service department of Avantor or local distributor of that.
Take out the foam cover, pull out the device and place it on a table.
4.2.2 Move the Analyser
The reagent kits on the top of the device ought to be removed before moving and transporting,
in case of falling down
Drain the liquid line of the analyser before moving
Protect the LCD screen and sample probe from external force when moving
Keep the device upright, avoid shake. DN NOT tilt it or put it on its side. Inspect and debug
before operation after moving it.
● The analyser must be placed on a sturdy and horizontal table, not placed on a slope.
● Please keep the packing box, in order to pack the analyser when moving a long distance.
4-3
4.3 Installation Procedure
Operator should wear on gloves and avoid direct contact with sample probe. Because sample
probe is sharp, sample loader, sample probe, column and pretreatment column may carry with blood
and QC material and calibrator is bio-hazard
The cloths, hair and hands should keep a certain distance from moving parts like sample probe
and sample loader, in case of crushing or stabbing
4.3.1 Cut the Cable Ties
The 2D arm will be tied to metal plate with cable ties to avoid damage. Cut the cable ties
before use. See detailed steps below.
1. Follow the direction of the arrows to open the door catches on the right and rear side. And
open the doors. As shown in picture 4-1:
Picture 4-1 Open the right and rear doors
4-4
2. Cut off the cable ties with scissor or diagonal pliers. See in picture 4-2.
X axis fixed tie
Z axis fixed tie
Picture 4-2 Cable ties
3. Push 2D arm slightly to recover to free status, the optocoupler lights of the two arms will turn
on, shown as below.
Z axis optocoupler
X axis optocoupler
Picture 4-3 2D arms recover to normal free status
4-5
4.3.2 Reagent Connection
● Operators are in duty to bound to local laws and regulations about disposing overdue reagents, waste
liquid, waste samples and consumables.
● Reagents may irritate eyes, skin and mucous membranes. Operators ought to comply with safety
regulations and wear on personal protective equipments (like protective clothing, gloves).
● Once the reagent contact with skin, wash immediately with plenty of water, if necessary, please seek
medical treatment; Once the reagent contact with eyes, rinse immediately with plenty of water and
seek medical treatment
● Must use specified reagent kits

● Ensure use reagents and columns before expiration date
● Cover the bottles after reagents and the analyser connected, in case of contamination
Place reagent kits on the top of the device, and the sequence of A elunet, B eluent, C eluent
and hemolytic agent should comply to Picture 4-4.Connect the end of reagent tube with Luer taper
to the Luer taper on the analyser. Fix the other end to regent bottle cover after passing through the
holes on reagent kit.
4-6
Reagent Kit
Picture 4-4 Reagent Connection
4.3.3 Waste Bottle
Take out the waste liquid tube with Luer taper. Place the waste bottle on the back side of the
analyser. Connect one end of waste tube to the waste connection on the rear side and the other end
to the waste bottle
4.3.4 Column and Pretreatment Column Installation
Operator should wear on gloves for safety operation due to the biohazard of column and
pretreatment column.
There might be reagents that soaked column or pretreatment column dropping on the device and
operating desk. So please prepare tissue for
cleaning.
Take out column and pretreatment column from reagent kit, clean up with a tissue. Connect
them according to the direction of the thread below.
4-7
Pretreatment Column Column
Picture 4-5 Connection of Pretreatment Column and Column
Take out connecting tubes of column and pretreatment column from reagent kit, clean up
with a tissue. Connect them according to the direction of the thread below
Screwed Joint
Luer Taper
Picture 4-6 Connection of Column and Pretreatment Column Connecting Tubes
4-8
Open left side door.
Picture 4-7 Opening Left Side Door
Install column and pretreatment column onto the device, and screw Luer tapers according to
marker No. on that. See the direction below.
Pretreatment Column
Vertically
Column Downward
Picture 4-8 Column and Pretreatment Column Installation
4-9
4.3.5 Thermal Paper Installation
Pull the holder on top right corner of printer, and open printer door. Load thermal paper
according to the direction in Picture 4-9, and leave a segment of paper outside the exit. Close the
door, and inspect thermal paper position, to ensure thermal paper aligning at the exit.
Thermal Paper
Picture 4-9 Thermal Paper Installation
4.3.6 Bar Code Scanner Connection
Connect bar code scanner to scanner port on the rear side. See in picture 4-10.
Scanner
Power Adapter
Picture 4-10 Scanner and Power Adapter Connection
4-10
4.3.7 Power Adapter Connection
Take out power adapter with three-core cord. Plug one end of power cord into power adapter
and the other end into socket. Then plug the output end of power adapter into the port on the rear
side of analyser. See in picture 4-10.
4.4 Start-up for the First Time
︱”).
Take out RFID card from standard reagent kit and Turn one the switch on the rear side( “︱
Swipe the RFID card when the screen prompts to swipe card. And the system will run self test and
system cleaning program.
Picture 4-11 Power on Self Test and System Cleaning
Click “Yes”, the system will enter menu interface in about 5 minutes.
4-11
Picture 4-12 Menu
Click “Service”, enter into service interface
Picture 4-13 Service
Press “System Maintenance”:
4-12
Picture 4-14 System Maintenance
Prime the liquid lien. Then press “Liquid Line Rinse” to keep ADC value between
17,000~19,000.
If encounter other malfunctions during operation above, refer to Chapter 11.
4-13
Chapter 5 Parameter Settings
Parameters of A9 Analyser had been initialized setting before dispatched from the factory.
All the parameters are defaulted by the system for the first start-up. To meet the actual needs of
those laboratories, user could reset those parameters.
5-1
5.1 Printer Settings
Press “Settings” to enter the mode on Menu interface,
Picture 5-1 Settings
Select Yes or no to set whether to print out the results automatically after test.
5.2 Date and Time
Press the areas to enter Year, Month, Day, Hour, Minutes, Second to update system time.
Press “Ok” when complete inputs. The dialogue below will be shown on the display,
Picture 5-2 Time Setting Dialogue
Press “Yes” to modify the time.
5-2
5.3 Auto QC
It allows operator to select Auto QC function. That is when operator place QC material and
calibrator on sample loader, the system will start QC program first and then test samples
automatically.
Press “QC” icon to enter this mode.
Picture 5-2 QC
Select “Automatically start QC program before sample test”. The circle turning to green
means selected, and gray means closed.
5-3
Chapter 6 Daily Operation
This chapter introduces daily operation method of A9, and makes a detailed thorough
introduction about whole blood sample mode and prediluted sample mode.
See the daily operation flowchart below:
Preparation
Start up
QC
Prepare sample
Test Sample
Power off
6-1
6.1 Check before Operation
Before switching on the power, operator ought to check the system according to the
following requirements.
● Sample, QC material, calibrator, column, pretreatment column and waste liquid are bio-hazardous!
Operator should comply with laboratory safe regulations and wear on personnel protective
equipments (Safe clothing, gloves) when contacting lab articles.
● Operator is obliged to comply with local and national regulations about discharging reagents, waste,
waste samples, and consumables.
● Reagents may irritate eyes, skin and mucous membranes. Operator should comply with laboratory
safe regulations and wear on personnel protective equipments (Safe clothing, gloves) when contacting
lab articles.
1. Check Rest Reagent Volume

Check whether the rest volume of A eluent, B eluent, C eluent and Hemolytic agent are adequate or
not.
2. Waste Container
Check the waste container to ensure it’s empty before operating every day.
3. Liquid Line and Power Supply

Check whether reagent and waste liquid lines are kink or not, connections are reliable or not.
Check whether there is any leakage or not
Check whether the power plug into the socket or not.
4. Thermal Printer
Check whether there are adequate papers or not and the settings are ready or not.
5. Bar Code Scanner

Check the connection between bar code scanner and the analyzer.
6-2
6.2 Preparation before Operation
Switch on the power on the rear side (“I”), the screen will be on. About 2 seconds later the screen
will show available test numbers of column and pretreatment column and promote to swipe the RFID
card. Once operator swipes, the screen will turn to system POST(Power-On-Self-Test) and
self-cleaning confirmation interface.
Press “Yes”, the system will run POST and Self-cleaning program. The process will last 5 minutes.
Once completed, the system will enter Menu interface.
Press “No” to skip POST and Self-cleaning process and enter Menu interface directly.
If failure or malfunction occurs in initialization, the corresponding information will show on the
screen and sound “De-De-De” alarm continuously. Operator should troubleshoot and then conduct next
step. Refer to Chapter 11 for the methods of troubleshooting.
● Operator should run POST and Self-cleaning program every day. Otherwise it may lead to
malfunctions that cann’t be found or wrong results.
6.3 Daily QC
Before assaying the sample, operator ought to conduct QC procedure to ensure the analyzer could
get reliable results. See details steps of QC in Chapter 8.
6-3
6.4 Preparation for Sample
●Sample, QC material, calibrator, column, pretreatment column and waste liquid are bio-hazardous!
●DO NOT contact blood sample directly.
●DO NOT reuse disposable supplies
● Operator should use clean K2EDTA or Na2EDTA anticoagulant vacutainer, siliconized glass/ plastic
tubes, EP tubes and 20uL Borosilicate glass capillary.
6-4
6.4.1 Whole Blood Sample
See preparation method of whole blood sample below:

1. Use clean K2EDTA or Na2EDTA anticoagulant vacutainer（1.5～2.2mg/mL） to collect
venous blood.
2. Quickly thoroughly mix venous blood with anticoagulant in the tube.
3. Place the tube on the positions 1-19 or STAT position.
6.4.2 Prediluted Sample
See preparation method of prediluted sample below:

1. Aspirate 500uL deionized water into EP tube
2. Add 20uL venous whole blood or peripheral blood. Cover then shake it gently
3. Place the EP tube on the positions 21～24 of sample loader.
● It’s recommended that operator uses oscillator to shake t blood collection tube or prediluted EP
tube. Otherwise it may influence testing result.
● If there are bubbles or flock in the blood of blood collection tube, sample probe can not aspirate
blood sample. It might result in 0% result. Once it appears, shake the tubes thoroughly and test
it again.
6-5
6.5 Assay Whole Blood Sample
6.5.1 Load Sample Information
Press “Test” on Menu to enter Loading Sample Information interface, see the picture below.
Cursor
ID Area
Picture 6-1 Load Sample Information
There are two ways to input sample information: bar code scanner and manual input.
Bar Code Scanner Input Steps:
1. Click SN (serial number) of every sample position, when the cursor moves to
corresponding SN, it indicates to input information.
2. Press the switch of scanner, and scan dimensional codes that are on the blood collection
tubes. The information will show on the corresponding SN area. The End position will
add 1 automatically every time that it scans dimensional code successfully.
Manual Input Steps:
1. Click SN (serial number) of every sample position (1 - 19)
2. Input sample information with keypad
6-6
●The maximum length of the sample ID number 15, if it exceeds 15, the analyser will default
before 15 as the current ID number
6.5.2 Set Start Position and End Position
Click start position and end position respectively on Loading Sample Information interface.
Enter the numbers according to the actual positions. End position should no more than 19 and
Start position should no more than End position
● Samples should be placed consecutively (one by one). DO NOT leave space between Start and
End position. Otherwise, the result of blank position will be shown as 0%.
● When the set Start position is larger than End position, or there is not any input sample
information, it will alarm when pressing “Start Test”
6.5.3 Cancel Current Sample Information Input
When it needs to cancel sample information input, press “Cancel”. Press “Yes” when
popping up “Cancel current sample information input?”.
6.5.4 Cancel All Sample Information Input
When it needs to cancel all the sample information input, press “Cancel All”. Then press
“Yes” when popping up “Cancel all sample information input?”.
6.5.5 Sample Test
Press “Start Test”, on the top of the screen it shows “Press again to start test program”. If
auto QC function is on, the promote “Please confirm QC1 low level and QC2 high level QC
material is correct” will show on the top on the screen. Operator should press “”Start Test” again
to enter “In Testing Process” interface. See in the below.
6-7
Chromatogram
Test Result
Sample SN
Sample ID Eluting Time Status ADC Absorbance
Picture 6-2 In Testing Process
From left to right, the status columns are current sample SN, ID, eluting time, system status,
ADC value, absorbance and testing result.
After starting test, the system will complete whole blood assay.
● It prohibits viewing and printing sample information during the analysis!

● DO NOT conduct other settings operations during the analysis. Otherwise malfunction will
occur!
6-8
6.5.6 Emergency Stop
If sample probe stuck or fluid leakage appears, press “Emergency Stop” .Then press “Yes”
when popping up “Stop Testing?” dialogue. Or switch off the power directly on the rear and deal
with the problems referring to Chapter 11.
6.5.7Add Sample During Testing
If it needs to add sample during testing, press “edit”. Then press “Yes” when popping up “It’s
testing, are you sure to exit current interface?” dialogue. Refer to 6.5.1 and 6.5.2 to input sample
information and set Start position and End position. After that, press “Start Test” to back to
regular test.
6.5.8 Emergency Sample Loading
If it needs to load sample emergently, press “Edit”. Then press “Yes” when popping up “It’s
testing, are you sure to exit current interface” dialogue. After that, press ST position area, the
cursor will appear in the front of ST. Input sample information with scanner or manually. Once it
has been completed, press “Start Test” to back to regular test. The analyser will assay sample in
ST position in priority.
●Sample, QC material, calibrator, column, pretreatment column and waste liquid are bio-hazardous!
Avoid direct contact with blood sample.

probe is sharp, sample loader, sample probe, column and pretreatment column may carry with
blood and QC material and calibrator is bio-hazard
DO NOT place sample or touch sample loader when sample loader turning or sample probe
aspirating, in case of failure or malfunction.
6-9
● If door temperature exceeds the normal working temperature range of the analyser, the testing
results will be unreliable
6.6 Assay Prediluted Sample
6.6.1 Load Sample Information
Press “Test” on Menu to enter Loading Sample Information interface, see the picture below.
ID Area
Cursor
Picture 6-3 Load Sample Information
There are two ways to input sample information: bar code scanner and manual input.
Bar Code Scanner Input Steps:
3. Click SN (serial number) of every sample position, when the cursor moves to
corresponding SN, it indicates to input information.
4. Press the switch of scanner, and scan dimensional codes that are on the blood collection
tubes. The information will show on the corresponding SN area. The End position will
add 1 automatically every time that it scans dimensional code successfully.
Manual Input Steps:
3. Click SN (serial number) of every sample position (1 - 19)
4. Input sample information with keypad
6-10
●The maximum length of the sample ID number 15, if it exceeds 15, the analyser will default
6.6.2 Set Start Position and End Position
Click start position and end position respectively on Loading Sample Information interface.
Enter the numbers according to the actual positions. End position should no more than 19 and
Start position should no more than End position
● Samples should be placed consecutively (one by one). DO NOT leave space between Start and
End position. Otherwise, the result of blank position will be shown as 0%.
● When the set Start position is larger than End position, or there is not any input sample
information, it will alarm when pressing “Start Test”
6.6.3 Sample Test
Press “Start Test”, on the top of the screen it shows “Press again to start test program”. If
auto QC function is on, the promote “Please confirm QC1 low level and QC2 high level QC
material is correct” will show on the top on the screen. Operator should press “”Start Test” again
to enter “In Testing Process” interface. See in the below.
6-11
Chromatogram
Test Result
Sample SN
Sample ID Eluting Time Status ADC
Picture 6-4 In Test Process
From left to right, the status columns are current sample SN, ID, eluting time, system status,
ADC value, absorbance and testing result.
After starting test, the system will complete prediluted blood assay.

● DO NOT conduct other settings operations during the analysis. Otherwise malfunction will
occur!
6.6.4 Emergency Stop
If sample probe stuck or fluid leakage appears, press “Emergency Stop” .Then press “Yes”
when popping up “Stop Testing?” dialogue. Or switch off the power directly on the rear and deal
with the problems referring to Chapter 11.
6.6.5 Add Sample During Testing
If it needs to add sample during testing, press “edit”. Then press “Yes” when popping up “It’s
6-12
testing, are you sure to exit current interface?” dialogue. Refer to 6.6.1 and 6.6.2 to input sample
information and set Start position and End position. After that, press “Start Test” to back to
regular test.
Sample, QC material, calibrator, column, pretreatment column and waste liquid are bio-hazardous!
Avoid direct contact with blood sample.

●DO NOT reuse disposable supplies
6.7 Power Off
Execute following shutdown procedures before switch off the power everyday:
1. Enter Menu interface
6-13
Picture 6-5 Menu
2. Press “Power Off”, popping up the dialogue below
Picture 6-6 Power off Dialogue
3. Press “Yes”, entering the following interface
6-14
Picture 6-7 Shutting Down
4. After 90 seconds, the shutdown program has been completed, the promotion below will
display on the screen.
6-15
Picture 6-8 Complete Shutdown Program
5. Turn off the switch on the rear of the analyzer.

6. Empty the waste bottle and discharge waste liquid properly.
●Operator is obliged to comply with local and national regulations about discharging reagents, waste,
waste samples, and consumables.
6-16
Chapter 7 Data Query
A9 will store testing results to database automatically after every single test. The maximum
storage is 10,000 testing result, including 26 parameters and 1 chromatogram. Operator could
review and query all the stored parameters and chromatograms by pressing “Prev” or “Next”.
7-1
7.1 Data Exploration
The analyser provides up and down browsing method to explore the results. Press “Query” to
enter query mode on Menu interface:
Picture 7-1 Data Query
Browsing Data
Operator could browse sample testing result. View the results one by one by pressing “Prev”
and “Next”. There are total quantities of database, current sample SN, sample ID, sample type,
test date and chromatogram shown on Data Query interface.
Encoding rule of sample SN: Sample ID – Sample Loader Position No..
7.2 Delete Data
Delete current sample data
Operator could delete testing results of current sample. Press “Delete”, popping up dialogue
box:
7-2
Picture 7-2 Dialogue Box of Deleting Current Sample Data
Press “Yes” to proceed.
Delete all sample data
Operator could delete testing results of all samples. Press “Delete All”, popping up dialogue
box:
Picture 7-3 Dialogue Box of Deleting All Samples Data
Press “Yes” to proceed.
● Once data has been deleted, they can’t be recovered. It’s recommended to print or keep data
backup by connecting to computer with RS232 serial port line. Contact the manufacturer and
authorized distributors for backup software.
7-3
7.3 Print Result
Print out current sample data
Operator could print out current sample date. Press “Print”, popping up the following
dialogue box.
Picture 7-4 Dialogue Box of Printing Current Sample Data
Press “Yes” to proceed with printing. See “Appendix A Specification” about related
description of printer format.
7-4
Chapter 8 Quality Control
A9 HbA1c Analyser may have a certain degree of error in the process of long-term use. The
existence of error could lead to mistakes or unreliable test results. QC (Quality Control) program
provides a effective method to detect possible error. Only be familiar with quality control theory
and master operation method, can operator eliminate the error influence on the test results
effectively.
In order to guarantee the reliability of the sample test results, operator should conduct QC
procedure with low level and high level QC materials every day.
8-1
8.1QC Material Information Input
Press “QC” on Menu to enter QC interface.
Picture 8-1 QC Information
There are two methods to input or change QC material information – scanner input and
manual input.
1. Scanner Input
Switch on bar code scanner, and scan dimension codes on QC material cryovial. The
dimension code information will show in corresponding area of low/high level QC material.
2. Manual Input
Press effective display area of Lot No., target value and SD value of low/high level QC
materials, to enter QC information.
Press “Cancel” to cancel information input, pop up the dialogue box below:
8-2
Picture 8-2 Cancel QC Material Information Input
Press “Yes”;
After finishing input, press “Save”. The dialogue box below pops up:
Picture 8-3 Save QC Material Information Input

Press “Yes” to confirm.
● The length of lot Nos. is 15. If exceeding, the system will default the first 15 numbers as current
lot No..
● Low level target value should be 1 integer place and 1 decimal place. High level target value
should be 2 integer places and 1 decimal place. If not, the analyser will indicate an error.
● Low level SD value should be 1 integer place and 2 decimal places. High level SD value should
be 1 integer place and 2 decimal places. If not, the analyser will indicate an error.
● Once lot Nos. being changed, all the original QC data will be overwritten. It’s recommended to
print or keep data backup by connecting to computer with RS232 serial port line. Contact the
manufacturer and authorized distributors for backup software.
8.2 Auto QC
8-3
The analyzer allows to setting auto QC function – when operator places QC material and
sample on sample loader at the same time, the analyzer will execute QC program first and then
assay sample automatically.
Select “Automatically start QC program before sample test”. The circle turning to green
means selected, and gray means closed.
8.3 Start QC
● Operator should use specific QC material designated by Avantor. Avantor takes no responsibility for
inaccurate QC result by using any other QC materials
● Refer to QC material user manual for its usage and storage methods
See test steps of QC material below:

2. Add 20uL QC material. Cover then shake it gently and thoroughly
3. Place low level EP tube on the QC1 position of sample loader, high level EP tube on QC2
position of sample loader. Then start test.
Press “Start QC”, popping up the dialogue box below.
8-4
Picture 8-4 Start QC
Press “Yes” to start QC.
● If bubbles form during QC test, the system will set related parameter to no avail and alarm. See
Chapter 11 for how to solve this problem.
● If door temperature exceeds normal working temperature range, obtained results may be unreliable.
8.4 QC Statistics
Once QC repeats 5 times, the system will start QC statistics.

Press “QC Statistic” to enter the interface.
8-5
Picture 8-5 QC Statistic
The QC statistic items include MEAN, SD and CV of low/high level QC material. Press
“Print” to print these data, popping up the dialogue box:
Picture 8-6 Print QC Statistic Record

If QC repeats less than 5 times, on the top of the screen will show: Warm Prompt: QC Test
Time <5! N=0”.
8-6
8.5 QC Curve
Press “QC Curve” to view the low level (default) QC curve.
Picture 8-7 Low Level QC Curve
The QC curves of the last 30 times can be reviewed in the analyser.

Press “High Level” to view high level QC curve if need.
If want to print out these QC curves, please press “Print”, popping up the following dialogue
box.
Picture 8-8 Print QC Curve Dialogue Box

8-7
Chapter 9 Calibration
Calibrating the analyser is to ensure the accuracy of the test results. In order to obtain reliable
results, operators should calibrate the system according to the procedures written in this chapter.
The quality of calibration depends on the quality of used column, pretreatment column,
calibrator and reagents. Users ought to use specified column, pretreatment column, calibrator and
reagents and follow the instructions and guide to use and store.
9-1
9.1 Calibration Frequency
The analyser has been calibrated before dispatched from the factory. Only in the three
circumstances, can the operator calibrate the analyser.
First installation
After replace column or pretreatment column
Long periods of inactivity, and to recover
Obvious deviation appears when running QC program
● Only after the analyser calibrated, can the measured data be used as valid data
9.2 Calibration Method
There are two kinds of calibration methods: auto calibration and manual calibration. During
auto calibration or manual calibration, all the mathematical calculation related are been executed
by the analyser. Calibrated calibration factor will be stored automatically. The system can auto
store this and last calibration factor.
Preparation before Calibration
Follow the bellowing steps to prepare. If problems were found, DO NOT calibrate. Operator
should find out the causes. Solve the problems and then determine whether it needs calibration. If
can’t solve, contact the service department of Avantor.
1. Check analyzer and reagent and ensure the reagent volume is adequate for the whole
calibration process. If the reagents run out during calibration, it needs to be calibrated another
time.
2. Check available test numbers of column and pretreatment column when starting up. If the
available number is zero, please handle according to Chapter 11.Make sure the available
numbers of column and pretreatment column meet requirements.
3. Check whether ADC value is within 17000-19000. If not, run “Rinse Liquid Line”
program. If the problems still exist, increase/decrease the LED value.
9-2
9.3 Calibrator Information Input
Press “Calibration” on Menu to enter calibrator information interface.
Picture 9-1 Calibrator Information
There are two methods to input or change calibrator information: scanner input and manual
input.
1. Scanner Input
Switch on bar code scanner, and scan dimension codes on calibrator cryovial. The dimension
code information will show in corresponding area of low/high level calibrator.
2. Manual Input
Press effective display area of Lot No., target value and SD value of low/high level
calibrators, to enter calibration information.
Press “Cancel” to cancel information input, pop up the dialogue box below:
9-3
Picture 9-2 Cancel Calibrator Information Input
Press “Yes”.
After finishing input, press “Save”. The dialogue box below pops up:
Picture 9-3 Save Calibrator Information Input

9.4 Start Calibration
9-4
● Operator should use specific calibrator designated by Avantor. Avantor takes no responsibility for
inaccurate calibration result by using any other calibrator
● Refer to calibrator user manual for its usage and storage
method
See test steps of calibrator below:

4. Add 20uL calibrator. Cover then shake it gently and thoroughly
3. Place low level EP tube on the C1 position of sample loader, high level EP tube on C2
position of sample loader. Then start test.
Press “Start Calibration”, popping up the dialogue box below.
Picture 9-4 Start Calibration
Press “Yes” to start calibration test. It will jump to calibration query interface automatically
after calibration (Picture 9-10).
To save this calibration result, operator should press “Save”, popping up the following
dialogue box:
9-5
Picture 9-5 Save Calibration Result
Press “Yes” to save the calibration factor.

Operator can press “cancel” to cancel saving the calibration result. Pop up the dialogue
below:
Picture 9-6 Cancel Calibration Result
● If bubbles form during calibration test, the system will set related parameter to no avail and alarm.
See Chapter 11 for how to solve this problem.
9-6
9.5 Manual Calibration
The analyser allows operator enter calibration factor manually. Press “Manual Calibration” to
start.
Picture 9-7 Manual Calibration
Operator press Factor/Offset area to input corresponding factors. Press “Yes”, popping up
the dialogue box below.
Picture 9-8 Save Calibration Result
9-7
Press “Yes” to save the manual calibration result.
To cancel those input factors, press “cancel” and the dialogue box pops up:
Picture 9-9 Cancel Calibration Result
Press “Yes” to cancel.
● The factor range is 0.0001～9.9999，and offset range is -9.9999～9.9999. Default as 1 integer

place and 4 decimal places. The analyser will indicates an error if beyond the ranges.
9.6 Calibration Query
Press “Calibration Query” to view the calibration records:
9-8
Picture 9-10 Calibration Query 10/11/2016
To print out calibration information, press “Print”. The following dialogue box pops up.
Picture 9-11 Print out Calibration Information
9-9
Chapter 10 Service
To keep the analyser workings accurately and effectively, operator should perform routine
maintenance according to the procedures in this chapter. The analyser provides various
maintenance functions, to facilitate the operator to complete maintenance work.
This chapter describes the various maintenance functions of A9 HbA1c analyser and some
measures when encountering failure and alarm.
● Surface of all the assembly units of A9 are bio-hazard, please take safety and protective measures
when operating and maintaining.
● Sample loader, sample probe, column and pretreatment column might be contaminate by blood. QC
material and calibrator are bio-hazardous! Operator should wear on gloves while operating and avoid
direct contact with sample probe.
● Improper maintenance may damage the analyser. Operator must follow the guidance manual for
maintenance.
● If you encounter problems that there is no clear instructions, please contact Service Department of
Avantor. Designated professionals will offer maintenance advises.
● Must use components and parts that provided by Avantor for maintenance. Any questions, please
contact Service Department of Avantor.
10-1
10.1 Maintenance Guide
Inspection before Test
Appearance No dust and scratches externally, liquid lines well connected, thermal printer
no lack of paper, no leakage and no physical damage.
Safety Well grounding and connection. The indicator light is on.
Column Available number is more than 0.
Pretreatment Column Available number is more than 0.
Reagent Use designated reagent, adequate hemolytic agent, adequate A/B/C eluent and
waste bottle has been emptied.
Operation Correct date and time, LCD screen performs well. A long time beep after
start-up, available numbers of column and pretreatment column shown on the
screen, swipe-card program is normal.
10.2 Daily Service
Press “Service” to enter the interface:
Picture 10-1 Service
The interface shows information about column and pretreatment column, temperatures of
10-2
mixing cup, column and environment, ADC value and LED value of sample aspiration system.
● Operator must use designated and specific column and pretreatment columns. Avantor takes no
responsibility for inaccurate test results by using any other columns or pretreatment columns.
● Before unsealing the columns and pretreatment columns unsealed, operator should check whether the
packaging is damaged. If damage results in column and pretreatment unusable, please contact
Service Department of Avantor immediately.
10.2.1 Column Information
The analyser will read then write the information of RFID card into system when start-up.
Column is consumable and initial available time is 420 T (not including calibration and QC).
Tested number of column means tested sample quantity by the column. Test 1 time, the system
automatically counts 1 and will keep the same with RFID card when booting. If the available
number is 0, operator should change new column and RFID card. Otherwise, the system will not
boot. Refer to Chapter10.4.5 How To Replace Column. When swiping with new RFID card, the
tested number of column clears to 0, and available time resets to 420 T.
10.2.2 Pretreatment Information
Pretreatment column is consumable and initial available time is 200 T (not including
calibration and QC). Tested number of pretreatment column means tested sample quantity by the
pretreatment column. Test 1 time, the system automatically counts 1 and will keep the same with
RFID card when booting. If the available number is 0, operator should change new pretreatment
column and RFID card. Refer to Chapter10.4.5 How To Replace Column. Once finished, press
“Reset”, popping up the following dialogue box.
Picture 10-2 Reset Pretreatment Column Tested Number
10-3
10.2.3 RFID Card
Every column matched with a RFID card. If operator use non-Avantor RFID card, or use
waste/invalid card, system will indicate an error. If RFID card lost, please contact Service
Department of Avantor.
10.2.4 Temperature of Mixing Cup
Mixing cup is used for mixing blood sample and hemolytic agent and incubation, as heating
can speed up hemolysis process. The temperature range of mixing cup is 52-54 °C, set as 53 °C
when dispatching. If the temperature can not reach to the range after 5 minutes of booting, adjust
slightly by pressing “+”or “-”. If it still can get to the range 2 minutes later, the temperature
control system of mixing cup may be broken, please contact Service Department of Avantor
immediately.
10.2.5 Temperature of Column
Function of column thermostat is to ensure elute at constant temperature 25 °C. If the

temperature can not reach to 25±1 °C after 5 minutes of booting, adjust slightly by pressing “+”or
“-”. If it still can get to the range 2 minutes later, the temperature control system of column
thermostat may be broken, please contact Service Department of Avantor immediately.
10.2.6 Enviro nment Temperature
Normal working temperature of the analyser is 15～35℃, suggest 25℃. Exceeding the range
may affect test results, please adjust the environment temperature according to real temperature.
10.2.7 LED Value
The analyser uses high-performance high-brightness LED lamp as its light source, and allows
24 hours standby. LED value reflects the brightness of LED light source, normal range is 420～
480. The greater the value is, the brighter the light is. Press “+”or “-” to adjust LED value. And
press “On/Off” to switch on/off the LED light. Check optical system of the analyser in this way.
10.2.8 Potential Detection
The analyser adopts high-precision optical sampling system. In normal state, ADC ranges
from 17,000 to 19,000. Voltage is kind of photoelectric converting analog input voltage.
10-4
Absorbance could be calculated as:
20000
ABS = lg
ADC
If the ADC value is not normal, run bubbles elimination and the liquid line cleaning program.
If LED value it still out of this range after this step, fine adjust LED value by pressing “+” or “-”.
Every time pressing “+” or “-” needs to wait 30 seconds before the 2nd hit.
10.3 System Maintenance
Press “System Maintenance” to enter the interface below:
Picture 10-3 System Maintenance
10.3.1 Prime A Eluent
Press “Prime A Eluent” to prime liquid line 1 minute by A eluent.
10.3.2 Prime B Eluent
Press “Prime B Eluent” to prime liquid line 1 minute by B eluent.
10-5
10.3.3 Prime C Eluent
Press “Prime C Eluent” to prime liquid line 1 minute by C eluent
10.3.4 Prime Hemolytic Agent
Press “Prime Hemolytic Agent” to dispose 400uL hemolytic agent by the plunger pump.
10.3.5 Liquid Line Rinse
Under the circumstances below, operator should conduct liquid line rinse procedure: Every
time that operator replaces A eluent, B eluent, C eluent, hemolytic agent, column, pretreatment
column and peristaltic pump pipe; Accidental electrical outage during normal testing; Execute
emergency stop program. Press “Liquid Line Rinse”. On the top of the screen will show
“Complete Liquid Line Rinse!” after about 6 minutes
later.
● Operator must conduct liquid line rinse procedure when: Operator replaces A eluent, B eluent, C
eluent, hemolytic agent, column, pretreatment column and peristaltic pump pipe; Accidental
electrical outage during normal testing; Execute emergency stop program. Otherwise, wrong
results will be obtained for the first test.
10.3.6 Drain Liquid Line
If it needs to drain the inner fluid, please disconnect the lines that connect with A/B/C eluent
and hemolytic agent, then press “Drain Liquid Line”. The system will run drain program that will
last about 5 minutes. On the top of the screen will show “Complete Liquid Line Drain!”.
10.3.7 Liquid Line Counter-rinse
If it needs to counter-rinse the liquid line, press “Liquid Line Counter-rinse”. System will
counter-rinse the liquid with A eluent. On the top of the screen will show “Complete Liquid Line
Counter-rinse!” about 2 minutes later.
10.3.8 Bubble Elimination
The existence of bubbles in cuvette will seriously affect the stability and reliability, and ADC
value couldn’t keep between 17,000～19,000 . Under this situation, bubbles must be eliminated.
10-6
Press “Bubble Elimination”. About 4 minutes later, on the top of the screen will show “Complete
Bubble Elimination, Please Observe ADC Value! ”. Operator should observe the ADC value
carefully. If bubbles still exist, please refer to 10.2.8.
10.3.9 Priming
When the analyser was installed firstly or reuse after draining the liquid line, Press “Priming”
to prime the whole liquid line. About 6 minutes later, on the top of the screen will show
“Complete Priming, Please Observe ADC Value! ”. Operator should observe the ADC value
carefully. If bubbles still exist, please refer to 10.2.8.
10.3.9 Mixing Cup Wash
If it needs to wash the mixing cup, press “Mixing Cup Wash”. On the top of the screen will
show “Complete Mixing Cup Wash!” after 2 minutes later.
10.3.10 Motor Reset
Press “Motor Reset”, to reset motor (pack up sample probe to the inner of the analyser).
10.3.11 Printer Test
After installing printer paper, press “Printer Test”. System will print out the content below:
“********Avantor*********”.
10.4Help
The analyser provides help information for users, such as working principle, manufacturer
contact etc. Press “Help” to enter the interface:
10-7
Picture 10-4 Help Information
10.4.1 Working Principle
Press “Working Principle” and the following interface will appear:
Picture 10-5 Working Principle
10-8
It introduces working principle that how to elute different contents of glycosylated
hemoglobin.
10.4.2 How to Replace Thermal Print Paper
Press “How to Replace Thermal Print Paper”, shown as below:
Picture 10-6 Replace Thermal Print Paper
It introduces steps to install thermal paper.
10.4.3 Contact Us
Press “Contact us”, shown as below:
10-9
Picture 10-7 Contact us
10.4.4 How to Install Pretreatment Column
Press “How to Install Pretreatment Column”, shown as below:
10-10
Picture 10-8 How to install pretreatment column
10.4.5 How to Install Column
Press “How to Install Column”, shown as below:
10-11
Picture 10-9 How to Install Column
10.4.6 How to Replace Peristaltic Pump Pipe
Press “How to Replace Peristaltic Pump Pipe”, shown as below:
10-12
Picture 10-10 How to Replace Peristaltic Pump Pipe
10.4.7 How to Judge the Liquid Line is Blocked
Press “How to Judge the Liquid Line is Blocked”, shown as below:
Picture 10-11 Judge Liquid Line is Blocked
10-13
10.4.8 How to Deal with Leakage
Press “How to Deal with Leakage”, shown as below:
Picture 10-11 How to Deal with Leakage
10.4.9 When to Eliminate Bubbles
Press “When to Eliminate Bubbles”, shown as below:
10-14
Picture 10-12 When to Eliminate Bubble
10-15
Chapter 11 Troubleshooting
In this chapter we introduce possible failures and malfunctions and provide trouble shootings
methods.
● When repairing and fixing, shut down the power! It may damage electrical components with analyser
on!
● In case of inaccurate test results, be sure to analyze samples after troubleshooting when faulty alarms
appear.
● This manual can’t be considered as repair manual. Only can be use for basic troubleshooting when
faulty alarm appears.
11-1
11.1 Faults and Troubleshooting
If there is a fault phenomena listed in the table below before or during use, please refer to the
relevant troubleshooting steps to removal. if the fault persists, please contact Service Department
of Avantor.
Faults Cause Troubleshooting Steps

Analyser fails to 1. Linkage fault 1. Examine power cord connection
run after switch 2. Adapter broken 2. Check whether adapter indicator lights
on the power 3. AC outlet no power 3. Confirm electric power supply
Fluid leakage 1. Peristaltic pump pipe is 1. Replace another peristaltic pump pipe
broken 2. Replace another Luer tapper
2. Luer tapper is broken 3. Tighten Luer tapper
3. Luer tapper aren’t screwed 4. Replace another pretreatment column
tightly 5. Screw down pretreatment column and column
4. Pretreatment column is
blocked
5. Connection between
pretreatment column and
column becomes loose
Printer fails to 1. Out of paper 1. Prepare papers
work 2. Paper jam 2. Removal the jammed paper
3. Electrical circuit is broken 3. Enter system maintenance, press “Printer Test”. If
test fails, replace for another PCB or thermal
printer
Sample loader 1. Poor contact of the 1. Pull out/in connecting line again
fails to rotate or positioning optocoupler 2. Change for another optocoupler
rotated position signal line or motor 3. Change for another motor
is not in place 2. positioning optocoupler
broken
3. Motor failure
Touch screen 1. Touch screen was installed 1. Loosen the screws
input abnormal tightly 2. Change for another screen
2. Touch screen broken
Peristaltic pump 1. Poor contact of motor 1. Pull out/in connecting line again
does not rotate signal line 2. Change for another motor
2. Motor failure 3. Change for another mainboard
3. Mainboard broken
Fail to swipe 1. Broken card 1. Change for a new card
card or swiping 2. Poor contact of RFID 2. Pull out/in connecting line again
card fault persists connecting lines 3. Change for another RFID reader
3. RFID reader broken 4. Change for another mainboard
11-2
4. Mainboard broken
Test result is 0% 1. There are bubbles, or 1. Shake the blood collection tube and then put it to
flocs in blood test again
2. Software process error 2. Contact Service Department to update software
11.2 System Checkout Information and Troubleshooting
In the process of operation, if system detects abnormal conditions, it will indicate

corresponding prompt message and sound continued “De-de-de”. Operator should solve these
problems according to the troubleshooting methods in this section. If problems persist, please
contact Service Department of Avantor for solutions.

Real-time 1. LCD screen battery had be 1. Press ”Settings”→“Time & Date”,
clock fault pulled out reset the time
2. Poor contact of battery, or 2. Change for another battery
invalid battery
Plunger pump 1. Poor contact of the 1. Pull out/in connecting line again
fault positioning optocoupler 2. Change for another optocoupler
signal line or motor 3. Change for another motor
2. Positioning optocoupler 4. Open the rear side door to check
broken whether the pump core reaches to top.
3. Motor broken If so, press “Service” –“System
4. Pump core get stuck Maintenance”, and run “Dispose
Hemolytic Agent” program
2D arm 1. Sample probe get stuck 1. Open the right side door and check
2. Poor contact of the whether sample probe has been stuck
positioning optocoupler 2. Pull out/in connecting line again
signal line or motor 3. Change for another optocoupler
3. Positioning optocoupler 4. Change for another motor
broken
4. Motor broken
11.3 Optical System Faults and Troubleshooting
If test ADC value abnormal during operation, operator should troubleshoot according to the
steps below. If the problem persists, please contact Service Department of Avantor for solutions.

ADC value is 0 1. Bad contact of acquisition 1. Pull out/in connecting line again
board or LED board signal 2. Change for another acquisition board
11-3
lines 3. Change for another LED board
2. Acquisition board broken
3. LED board broken
ADC value 1. LED value is set too high 1. Lower LED value manually
keeps above 2. Acquisition broken 2. Change for another acquisition board
20,000 3. Bubbles in the cuvette 3. Execute “Bubble Elimination” program
11.4 Temperature Fault and Troubleshooting
In the process of testing, if the system detects abnormal conditions about temperatures of
mixing cup, column or environment, operator should troubleshoot according to the steps below. If
the problems persist, please contact Service Department of Avantor for solutions.

Mixing cup temperature 1. Mixing cup temperature 1. Press “Service”, and then press “+” to
approach to environment is set too low increase mixing cup temperature
temperature 2. Heating film broken 2. Change for another heating film
Mixing cup temperature 1. Mixing cup temperature 1. Low down mixing cup temperature
is unstable is set too high 2. Change for another mixing cup
2. Temperature sensor temperature sensor
broken
Column can not be 1. Bad contact of PET 1. Pull out/in PET connecting line again
cooled or heated connecting line 2. Change for another PET
2. PET broken
Cooling fan fails to work 1. Bad contact of cooling 1. Pull out/in cooling fan connecting line
fan connecting line again
2. Cooling fan broken 2. Change for another cooling fan
Temperature is 0 1. Bad contact of 1. Plug out/in temperature sensor socket
temperature sensor signal 2. Change for another temperature
line sensor
2. Temperature sensor
broken
11.5 Outer Connection Fault and Troubleshooting
In the process of testing, if outer component connections are abnormal, operator should
troubleshoot according to the steps below. If the problems persist, please contact Service
Department of Avantor for solutions.
11-4
Communicati 1. Communication connection 1. Check whether the connections are
on fault becomes loose correct
2. Analyser communication 2. Modify software of received end
parameter isn’t compatible referring to Appendix C
with received end Communication
Bar code 1. Bar code scanner isn’t 1. Check whether bar code scanner has
scanner connected properly been connected correctly
communicati 2. Connecting line between serial 2. Check whether connection between
on failure port board and mainboard serial port board and mainboard is
becomes loose correct
Invalid bar 1. Bar code scanner couldn’t Please contact Service Department of
code match Avantor
2. Invalid bar code data
3. Baud rate of bar code scanner
is wrong
11.6 Faults of Reagents, Column or Pretreatment Column and
Troubleshooting
In the process of testing, if faults of reagents, column and pretreatment column result in
system malfunction, operator should troubleshoot according to the steps below. If the problems
persist, please contact Service Department of Avantor for solutions.

No hemolytic 1. Connecting tube of 1. Check the connection
agent hemolytic agent has not 2. Check whether hemolytic agent has
reach into fluid ran out
2. Hemolytic agent runs out
No A eluent 1. Connecting tube of A eluent 1. Check the connection
has not reach into fluid 2. Check whether A eluent has ran out
2. A eluent runs out
No B eluent 1. Connecting tube of B eluent 1. Check the connection
has not reach into fluid 2. Check whether B eluent has ran out
2. B eluent runs out
No C eluent 1. Connecting tube of C eluent 1. Check the connection
has not reach into fluid 2. Check whether C eluent has ran out
2. C eluent runs out
Bubble appears A/B/C eluent has been ran out or Check connection and the volume of
the tubes doesn’t reach into the reagents
fluid
11-5
Abnormal 1. Liquid line blocked 1. Replace column and then rinse the
chromatogram 2. Pretreatment column or system
column becomes valid 2. Replace column or pretreatment
3. Reagents become valid column
4. Environment temperature is 3. Replace reagents
4. Adjust environment temperature to
higher than 35℃ or lower

10℃-35℃
5. Eliminate bubbles
than 10℃
5. Bubbles form
Test range 1. Liquid line blocked 1. Replace column and then rinse the
exceeds 2. Pretreatment column or system
3%-18% column becomes valid 2. Replace column or pretreatment
3. Reagents become valid column
4. Environment temperature is 3. Replace reagents
4. Adjust environment temperature to
higher than 35℃ or lower than

10℃-35℃
5. Eliminate bubbles
10℃
5. Bubbles form
11-6
Appendix A Specification
A.1 Product Classification
A9 could be classified by the standard below:
China Medical Equipment Management Classification:
Belong to clinical analytical instrument hematology system, Class Ⅱ
A.2 Reagent Kit
A eluent, B eluent, C eluent and hemolytic agent
A.3 Column, Pretreatment Column and Peristaltic Pump Pipe
Designated column, pretreatment column and peristaltic pump pipe
A.4 QC Material
Designated QC material
A.5 Calibrator
Designated calibrator
A.6 Power Input
Voltage：a.c.100V—240V
Frequency：50/60Hz
Input Power：150VA
A.7 Working Environment
Environment Temperature：10℃～35℃
Humidity：≤70%
Air Pressure：75kPa～106kPa
No frost, condensation, water seepage, wet and sun
A-1
A.8 Storage Temperature
Environment Temperature：0℃~55℃；
Humidity：≤93%；
Air Pressure：75kPa～106kPa
Storage Place：Instrument should be stored in well-ventilated, and does not allow acidic,
alkaline, and other harmful gases indoor.
Storage Lift：No more than 1 year
A.9 Dimensions
Length：43cm
Width：34cm
Height：45cm
A.10 Weight
20kg
A.11 Life Span
Life span is 5 years. More than 5 year service life of the machine shall be processed in
accordance with relevant laws and regulations, please contact the manufacturer or dealer for more
information.
A-2
A.12 Print Report
Print report includes the information: Model, test date, test time, sample type, sample SN
–sample loader SN, chromatogram, names of the three peaks, appearance time, absorbance, peak
area and ratio, converted content in IFCC, average concentration of blood glucose etc.
A-3
Appendix B Safety Information
B.1 Brief Description
In this manual we use the symbols below for the information that needs attention or is
hazardous
Symbol Meaning
otherwise it will result in personal injury
otherwise it will result in product failure, damage and inaccurate
results.
emphasize important/critical information or steps in the manual
otherwise it has bio-infectious risk.
B-1
B.2 Warning
● DO NOT operate in flammable and explosive environment

● The analyser must be used in a good grounding condition
● Make sure input voltage meet the requirements.
● Make sure the switch is off (“○”) before connecting power cord of adapter
● Operator should wear on gloves and avoid direct contact with sample probe. Because sample probe is
sharp, sample loader, sample probe, column and pretreatment column may carry with blood and QC
material and calibrator is bio-hazard.
● The cloths, hair and hands should keep a certain distance from moving parts like sample probe and
sample loader, in case of crushing or stabbing
● Operators are in duty to bound to local laws and regulations about disposing overdue reagents, waste
liquid, waste samples and consumables
● Reagents may irritate eyes, skin and mucous membranes. Operators ought to comply with safety
regulations and wear on personal protective equipments (like protective clothing, gloves).
● Once the reagent contact with skin, wash immediately with plenty of water, if necessary, please seek
medical treatment; Once the reagent contact with eyes, rinse immediately with plenty of water and
seek medical treatment.
● DO NOT contact blood sample directly.
● DO NOT conduct other settings operations during the analysis. Otherwise malfunction will occur!
● DO NOT place sample or touch sample loader when sample loader turning or sample probe
● When repairing and fixing, shut down the power! It may damage electrical components with analyser
on!
● Operation of the instrument should be conducted by the personnel that received formal
training, or master safe operation skills. For clinical trials, the instrument should be used in
charge of personnel management or clinical management personnel.
● To prevent electrical shock and / or equipment damage, operator should not open three covers of
the instrument. Only maintenance staff can be allowed to complete instrument maintenance or
repair.
● If the instrument's door open, DO NOT repair with the instrument power on. Powered touch
internal circuit will cause injury.
● Instrument installation must be equipped with reliable power outlet to ensure electrical safety.
● Anomalies appear in the power-on or during operation, the operator should immediately turn off
the power, and check by a qualified professional service personnel before re-power operation.
B-2
B.3 Caution
● It might damage the device to unpack and install without authorized or trained personnel. So do not
unpack or install the device without present of one authorized or trained personnel.
● DO NOT reuse disposable supplies
● If door temperature exceeds the normal working temperature range of the analyser, the testing results
will be unreliable
● Improper maintenance may damage the analyser. Operator must follow the guidance manual for
maintenance.
● If you encounter problems that there is no clear instructions, please contact Service Department of
Avantor. Designated professionals will offer maintenance advises.
● Must use components and parts that provided by Avantor for maintenance. Any questions, please
contact Service Department of
Avantor.
B-3
B.3 Note
● This manual is for and only for:

1. Daily operations personnel
2. System maintenance and troubleshooting personnel
3. Personnel that learn to use the system
● A9 Analyser is a diagnosis device that is used for disease screening. When diagnosing disease,
clinicians should take clinical examination results or other test result into consideration.
● Refer to the user manual of reagent to see how to use and store reagent
● After replace eluent, column, pretreatment column or hemolytic agent, the operator should rinse the
system to ensure ADC value in normal range
● Ensure use reagents, column and pretreatment column before expiration date
● If room temperature exceeds normal operating temperature range, the obtained results will be
inaccurate
● The analyser must be placed on a sturdy and horizontal table, not placed on a slope.
● Please keep the packing box, in order to pack the analyser when moving a long distance.
● Must use specified reagent kits
● Cover the bottles after reagents and the analyser connected, in case of contamination
● Operator should run POST and Self-cleaning program every day. Otherwise it may lead to
malfunctions that can’t be found or wrong results.
● Operator should wear on gloves for safety operation due to the biohazard of column and pretreatment
column.
● There might be reagents that soaked column or pretreatment column dropping on the device and
operating desk. So please prepare tissue for cleaning.
● Operator should use clean K2EDTA or Na2EDTA anticoagulant vacutainer, siliconized glass/ plastic
tubes, EP tubes and 20uL Borosilicate glass capillary.
● It’s recommended that operator uses oscillator to shake t blood collection tube or prediluted EP
tube. Otherwise it may influence testing result.
● If there are bubbles or flock in the blood of blood collection tube, sample probe can not aspirate
blood sample. It might result in 0% result. Once it appears, shake the tubes thoroughly and test
it again.
● The maximum length of the sample ID number 15, if it exceeds 15, the analyser will default
● Samples should be placed consecutively (one by one). DO NOT leave space between Start and End
position. Otherwise, the result of blank position will be shown as 0%.
● When the set Start position is larger than End position, or there is not any input sample information,
it will alarm when pressing “Start Test”
● Once data has been deleted, they can’t be recovered. It’s recommended to print or keep data
B-4
backup by connecting to computer with RS232 serial port line. Contact the manufacturer and
authorized distributors for backup software.
● The length of lot Nos. is 15. If exceeding, the system will default the first 15 numbers as current
lot No..
● Low level target value should be 1 integer place and 1 decimal place. High level target value
should be 2 integer places and 1 decimal place. If not, the analyser will indicate an error
● Low level SD value should be 1 integer place and 2 decimal places. High level SD value should
be 1 integer place and 2 decimal places. If not, the analyser will indicate an error
● Once lot Nos. being changed, all the original QC data will be overwritten. It’s recommended to
print or keep data backup by connecting to computer with RS232 serial port line. Contact the
manufacturer and authorized distributors for backup software
● Operator should use specific QC material designated by Avantor. Avantor takes no responsibility for
inaccurate QC result by using any other QC materials
● Refer to QC material user manual for its usage and storage methods
● If bubbles form during QC test, the system will set related parameter to no avail and alarm. See
Chapter 11 for how to solve this problem.
● Only after the analyser calibrated, can the measured data be used as valid data
● Operator should use specific calibrator designated by Avantor. Avantor takes no responsibility for
inaccurate calibration result by using any other calibrators
● Refer to calibrator user manual for its usage and storage method
● The factor range is 0.0001～9.9999，and offset range is -9.9999～9.9999. Default as 1 integer place
and 4 decimal places. The analyser will indicates an error if beyond the ranges.
● Operator must use designated and specific column and pretreatment columns. Avantor takes no
responsibility for inaccurate test results by using any other columns or pretreatment columns.
● Before unsealing the columns and pretreatment columns unsealed, operator should check whether the
packaging is damaged. If damage results in column and pretreatment unusable, please contact
Service Department of Avantor immediately.
● Operator must conduct liquid line rinse procedure when: Operator replaces A eluent, B eluent, C
eluent, hemolytic agent, column, pretreatment column and peristaltic pump pipe; Accidental
electrical outage during normal testing; Execute emergency stop program. Otherwise, wrong results
will be obtained for the first test.
● You must smear Vaseline on the surface of peristaltic pump pipe to prolong its life span.
● Do not allow the sample to remain in the pipeline for a long time, especially in chromatography
columns. Rinse liquid line after every test. DO NOT shut down the system during test. If
abnormalities appear, clean the system before test! when not in use lines and chromatography must
be filled with reagents.
● When the instrument is operating, DO NOT touch sensitive components such as optical systems and
other devices, otherwise it will cause measurement error results
B-5
B.4 Bio-Hazard
● Surface of all the assembly units of A9 are bio-hazard, please take safety and protective measures
when operating and maintaining.
● Sample loader, sample probe, column and pretreatment column might be contaminate by blood. QC
material and calibrator are bio-hazardous! Operator should wear on gloves while operating and avoid
direct contact with sample
probe.
B-6
Appendix C Communication
C.1 RS232 Communication Parameters
Baud Rate：115200
Stop Bit：1
Data Bit：1
Odd-even Check：No
Hardware Flow：No
Software Flow：No
C.2 Communications Instructions

Code
【STX】 0x02
“S” 0x53
“Q” 0x51
“C” 0x43
“#” 0x31-0x39
“*” 0x2A
“-” 0x2D
“+” 0x2B
“.” 0x2E
【ETX】 0x03
Blood type codes have the following meanings:
Code Meaning
0x30 Venous Blood
0x31 Diluted Blood
0x32 QC Material
0x33 Calibrator
C-1
C.3 Sample Data Format
Data start flag 【STX】

Data block specifier “S”
Version No. ##
Number of parameters ##
Parameter description format number ##
Code length ##
Sample SN. ###############
Separator “-”
Sample loader position ##
Blood type #
Year ##
Month ##
Day ##
Hour ##
Minute ##
Second ##
HbA1ab appearance time ###
HbA1c appearance time ###
HbA0 appearance time ###
HbA1ab absorbance #.####
HbA1c absorbance #.####
HbA0 absorbance #.####
HbA1ab peak area ###.###
HbA1c peak area ###.###
HbA0 peak area ###.###
HbA1ab peak area ratio ##.##
HbA1c peak area ratio ##.##
HbA0 peak area ratio ##.##
HbA1c content in IFCC ###.##
Average blood glucose ##.##
concentration in ADAG
Sent chromatographic curve number ###
Sent chromatographic curve values #.####
Erro Code #
Data endflag 【STX】
C-2
C.4 QC Data Format

Data block specifier “Q”
Lot No. length of low level QC material ##
Lot No. of low level QC material ###############
Lot No. length of high level QC material ##
Lot No. of high level QC material ###############
Low level QC target value ##.#
High level QC target value ##.#
Low level SD value #.##
High level SD value #.##
Low level QC material expiration date Year ##
Low level QC material expiration date Month ##
Low level QC material expiration date Day ##
High level QC material expiration date Year ##
High level QC material expiration date Month ##
High level QC material expiration date Day ##
Tested number of QC material ##
Low level QC material test value ##.##
High level QC material test value ##.##
Low level QC material average value ##.##
High level QC material average value ##.##
Low level QC material SD value #.####
High level Qc material SD value #.####
Low level QC material CV ##.##
High level QC material CV ##.##
C-3
C.5 Calibration Date Format

Data block specifier “C”
Lot No. length of low level calibrator ##
Lot No. of low level calibrator ###############
Lot No. length of high level calibrator ##
Lot No. of high level calibrator ###############
Low level calibrator concentration ##.#
High level calibrator concentration ##.#
Current calibration factor K #.####
Current calibration offset b +#.#### or -#.####
Current calibration date Year ##
Current calibration date Month ##
Current calibration date Day ##
C-4

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A9 HbA1c Analyser

Avantor Performance Materials

Avantor Performance Materials (hereinafter “Avantor”) has the copyright of this

Avantor has the right of final interpretation of this Manual.

The product has reached its lifetime limit;

Scope of free service:

Product is entitled to free service if it is within Avantor warranty provisions.

Scope of fee-based service:

Avantor Performance Materials India Limited Headquarters

This manual is for and only for:

1. Daily operations personnel

Chapter-1 Manual Brief Description......................................................................................................... 1

1.2 Scope of the Manual.................................................................................................................. 1

1.3 Content of the Manual........................................................................................................2

1.5 Symbols and Labels................................................................................................................... 3

Chapter 2 General Description.................................................................................................................. 1

2.1 Test Parameters......................................................................................................................... 1

2.2 Product Description...................................................................................................................2

2.2.1 LCD touch Screen.......................................................................................................................6

2.2.2 Thermal Printer.......................................................................................................................... 6

2.2.3 Computer Interface.................................................................................................................... 6

2.2.4 Bar Code Scanner Interface.......................................................................................................6

2.2.5 Printer Indicator and PF button............................................................................................... 6

2.2.6 Power Input Socket.....................................................................................................................6

2.3 Operation Interface................................................................................................................... 8

2.3.2 Function Brief Introduction.......................................................................................................8

2.4 Reagent, column, pretreatment column, QC material and calibrator................................. 9

2.4.3 Pretreatment Column...............................................................................................................10

2.4.4 QC Material and Calibrator....................................................................................................10

Chapter 3 Working Principle..................................................................................................................... 1

3.1 Aspirate Sample......................................................................................................................... 2

3.2.1 Ion Exchange Theory..................................................................................................................2

3.2.2 Colorimetric Analysis Principle................................................................................................ 3

3.3 Resin Balance and System Rinse.............................................................................................. 5

4.1 Installation Requirements.........................................................................................................2

4.1.1 Environment Conditions............................................................................................................ 2

4.1.3 Power Supply...............................................................................................................................2

4.2 Open Package.............................................................................................................................3

4.2.1 Opening Steps..............................................................................................................................3

4.2.2 Move the Analyser...................................................................................................................... 3

4.3 Installation Procedure............................................................................................................... 4

4.3.1 Cut the Cable Ties.......................................................................................................................4

4.3.2 Reagent Connection....................................................................................................................6

4.3.3 Waste Bottle.................................................................................................................................7

4.3.4 Column and Pretreatment Column Installation...................................................................... 7

4.3.5 Thermal Paper Installation......................................................................................................10

4.3.7 Power Adapter Connection......................................................................................................11

4.4 Start-up for the First Time..................................................................................................... 11

Chapter 5 Parameter Settings.....................................................................................................................1

5.1 Printer Settings.......................................................................................................................... 2

5.2 Date and Time............................................................................................................................ 2

5.3 Auto QC...................................................................................................................................... 3

Chapter 6 Daily Operation.........................................................................................................................1

6.1 Check before Operation............................................................................................................ 2

6.2 Preparation before Operation.................................................................................................. 3

6.3 Daily QC..................................................................................................................................... 3

6.4 Preparation for Sample............................................................................................................. 4

6.4.1 Whole Blood Sample...................................................................................................................5

6.4.2 Prediluted Sample.......................................................................................................................5

6.5 Assay Whole Blood Sample.......................................................................................................6

6.5.1 Load Sample Information.......................................................................................................... 6

6.5.2 Set Start Position and End Position.......................................................................................... 7

6.5.3 Cancel Current Sample Information Input..............................................................................7