Autolumo Operation Manual

OPERATOR’S MANUAL
AutoLumo A2000 Plus

Automatic Luminescence Immunoassay Analyzer
VERSION : V1.1
AUTOBIO LABTEC INSTRUMENTS CO., LTD

Operator’s Manual
AutoLumo
Copyright Notice
This manual is copyrighted by Autobio Labtec Instruments Co. Ltd.(Hereinafter AUTOBIO). No
copying without AUTOBIO permission except as permitted by copyright law. Any counterfeit, pirate
will be claimed for legal liability.
AUTOBIO tries to ensure that all contents of this manual in its print publication are accurate.
However, to meet the requirements of the development, AUTOBIO still reserves the rights to
modify the manual without any notice to customers.
© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

I
Operator’s Manual
AutoLumo
Disclaimer
AUTOBIO is not responsible for any damages to the instrument result from any action of operators,
including but not limited to misoperation, using the wrong files, wrong operation not according to
the manual, no matter whether these damages are foreseeable or existed in fact, no matter
whether the liability belongs to tort (including negligence) involved in contract or not fulfilling the
Warranty, etc., such as any special, indirect and incidental damages due to data loss, anticipated
profit loss, etc. In any case, compensation amount paid by AUTOBIO is no more than the amount
received from User. The user will take full responsibility for the result obtained by using the
instrument as well as its related documents.
Contact
If you have any questions related to your AutoLumo A2000 Plus, Automatic Luminescence
Immunoassay Analyzer, please contact us by email with a short description of your question to the
address below. Any suggestions for improvements to our products and services are gladly
acceptable.
E-mail : [email protected]
Tel : [86]-400-056-9995
Website : http://www.autobio.com.cn
EC Representative
OBELIS S.A
Bd.Général Wahis, 53
1030 Brussels,
Belgium
In Vitro Diagnostic Medical Device
This product is used for In Vitro Diagnostic Purpose.
Waste Electrical and Electronic Equipment (WEEE)
II AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

Operator’s Manual
AutoLumo
In accordance with European Directive 2012/19/EU on Waste Electrical and
Electronic Equipment (WEEE), the presence of the left symbol on the product or
on its packaging indicates that this item must not be disposed of in the normal
unsorted municipal waste stream. Instead, it is the user’s responsibility to
dispose of this product by returning it to a collection point designated for the
recycling of electrical and electronic equipment waste. Separate collection of
this waste helps to optimize the recovery and recycling of any reclaimable
materials and also reduces the impact on human health and the environment.
For more information concerning the correct disposal of this product,
please contact your local authority or the dealer.

III
Operator’s Manual
AutoLumo
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION..................................................................................................1
1.1 System Description and Intended Use..............................................................................1
1.1.1 System Description............................................................................................1
1.1.2 Intended Use...................................................................................................... 1
1.2 Manual Content................................................................................................................ 1
1.3 Additive Supplies..............................................................................................................1
1.4 Technical Support............................................................................................................. 2
1.5 Manufacturer.................................................................................................................... 2
1.6 Service Provider............................................................................................................... 2
1.7 Product Information..........................................................................................................2
1.8 Precaution & Safety Symbol............................................................................................ 2
1.8.1 Safety Features..................................................................................................2
1.8.2 Protective Device............................................................................................... 3
1.8.3 Safety Symbol.................................................................................................... 3
1.8.4 Biological hazards..............................................................................................4
1.9 System Configuration and Feature................................................................................... 5
1.9.1 Space Requirement...........................................................................................5
1.9.2 Weight of Instrument......................................................................................... 5
1.9.3 Performance Parameters................................................................................. 5
1.10 Environment Requirement..............................................................................................7
1.11 Electrical Requirement................................................................................................... 8
1.11.1 Instrument......................................................................................................... 8
1.11.2 Computer...........................................................................................................8
1.11.3 Power Consumption........................................................................................ 9
1.11.4 Standby Power（UPS）.................................................................................9
1.12 Installation...................................................................................................................... 9
1.13 Warranty........................................................................................................................11
1.14 Used in Combination with other Products....................................................................13
CHAPTER 2 SYSTEM SUMMARY.........................................................................................14
2.1 System Description.........................................................................................................14
2.2 System Status & Control................................................................................................ 15
2.2.1 Status Indication...............................................................................................15
2.2.2 System Shortcut Buttons................................................................................ 15
2.2.3 System Control Button.................................................................................... 16
2.2.4 Other Buttons & Status Description.............................................................. 17
2.3 System Mode.................................................................................................................. 18
2.4 Shutdown & Restart....................................................................................................... 19
2.4.1 Shutting down instrument for a while............................................................19
2.4.2 Shutting down the PC..................................................................................................... 19
IV AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

Operator’s Manual
AutoLumo
2.4.3 Shutting down instrument for long time........................................................20
2.4.4 Sleeping instrument.........................................................................................20
2.4.5 Restarting instrument...................................................................................... 21
2.4.6 Restarting after long term shutdown.............................................................21
2.5 Function Navigation....................................................................................................... 22
2.5.1 Test Analysis..................................................................................................... 22
2.5.2 System Parameter Setting............................................................................. 26
2.5.3 Maintenance and Diagnosis................................................................... 27
CHAPTER 3 SPECIMEN OF PATIENTS...............................................................................28
3.1 Adding Rack and Specimen............................................................................................30
3.2 Editing Patient Information............................................................................................ 31
3.3 Editing Test Request.......................................................................................................32
3.4 Deleting Sample Racks and Samples............................................................................. 32
3.5 Requesting from LIS...................................................................................................... 33
CHAPTER 4 SAMPLE MANAGEMENT.................................................................................34
4.1 Requested....................................................................................................................... 34
4.2 In Progress...................................................................................................................... 35
4.3 Exception........................................................................................................................36
4.4 Work Pending................................................................................................................. 38
4.5 Daily Sample.................................................................................................................. 39
CHAPTER 5 TEST RESULTS................................................................................................. 41
5.1 Custom............................................................................................................................42
5.2 Filter............................................................................................................................... 42
5.3 Find.................................................................................................................................42
5.4 Details.............................................................................................................................42
5.5 Send to LIS..................................................................................................................... 42
5.6 Print................................................................................................................................ 42
5.7 Update.............................................................................................................................42
CHAPTER 6 CALIBRATION.................................................................................................... 43
6.1 Calibrator........................................................................................................................43
6.1.1 Add Calibrator...................................................................................................44
6.1.2 Edit Calibrator...................................................................................................45
6.2 Request Calibration........................................................................................................ 45
6.2.1 Enter “Request Calibration” Screen..............................................................45
6.2.2 Add Sample Racks & Calibrators.................................................................. 47
6.2.3 Edit Request Calibration................................................................................. 47
6.3 Calibration Result...........................................................................................................47
6.3.1 Filter................................................................................................................... 49
6.3.2 Review Data..................................................................................................... 49
CHAPTER 7 QUALITY CONTROL.........................................................................................52
7.1 Quality Control...............................................................................................................52
7.1.1 Add Control....................................................................................................... 53

V
Operator’s Manual
AutoLumo
7.1.2 Edit Control....................................................................................................... 53
7.2 QC Maintenance.............................................................................................................54
7.2.1 New Control...................................................................................................... 54
7.2.2 QC Request...................................................................................................... 55
7.3 QC Result....................................................................................................................... 57
7.3.1 Filter................................................................................................................... 58
7.3.2 Chart and Data................................................................................................. 59
CHAPTER 8 CONSUMABLE MATERIALS........................................................................... 61
8.1 On-Board Reagent.......................................................................................................... 61
8.1.1 View the reagent data..................................................................................... 62
8.1.2 Change Reagent..............................................................................................62
8.1.3 On-Board Change Reagent..................................................................................63
8.2 Reagent Inventory.......................................................................................................... 72
8.2.1 Filter................................................................................................................... 73
8.3 Reagent Alarm................................................................................................................ 74
8.3.1 Check The Reagent Alarm Information........................................................ 75
8.4 Bulk................................................................................................................................ 76
8.4.1 Change Substrate............................................................................................76
8.4.2 Add RV...............................................................................................................77
8.4.3 Clean Solid Waste........................................................................................... 77
8.4.4 Change Diluent.................................................................................................78
CHAPTER 9 SYSTEM SETTING............................................................................................79
9.1 System Setting................................................................................................................ 79
9.1.1 General Settings.............................................................................................. 80
9.1.2 Report Settings.................................................................................................81
9.1.3 LIS Communication Settings..........................................................................82
9.1.4 Administrator Password.................................................................................. 83
9.1.5 Backup Plan......................................................................................................84
9.1.6 About..................................................................................................................84
9.1.7 Circuit Version Number................................................................................... 85
9.2 Test Items........................................................................................................................86
9.2.1 Filter................................................................................................................... 87
9.2.2 Edit..................................................................................................................... 89
9.3 Test Panel........................................................................................................................90
9.4 Derived Results.............................................................................................................. 92
CHAPTER 10 MAINTENANCE............................................................................................... 94
10.1 Maintenance................................................................................................................. 94
10.2 Clean.............................................................................................................................96
10.3 Clean Inside.................................................................................................................. 98
10.4 Clean Outside............................................................................................................... 98
10.5 Debug........................................................................................................................... 99
10.6 System.................................................................................................................................. 99
VI AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

Operator’s Manual
AutoLumo
10.7 Reinitialization............................................................................................................. 99
CHAPTER 11 TEST OPERATION........................................................................................ 101
11.1 Preparation..................................................................................................................101
11.1.1 Instrument Position Check......................................................................... 101
11.1.2 Reagent Check.............................................................................................101
11.1.3 Chemiluminescent Substrate Check.........................................................103
11.1.4 Consumables Check................................................................................... 104
11.1.5 Instrument Initialization and Daily Cleaning.............................................108
11.1.6 Patient Test Request................................................................................... 112
11.1.7 Daily Maintenance....................................................................................... 116
11.1.8 Close The Instrument.................................................................................. 118
CHAPTER 12 DIAGNOSIS.................................................................................................... 119
CHAPTER 13 TROUBLESHOOTING.................................................................................. 121
CHAPTER 14 TRANSPORT AND STORAGE.................................................................... 125
14.1 Transport.....................................................................................................................125
14.2 Storage........................................................................................................................126
CHAPTER 15 EMC INFORMATION.....................................................................................127
APPENDIX 1.............................................................................................................................128
Fatal Flag............................................................................................................................ 128
Non-Fatal Flag....................................................................................................................133
APPENDIX 2............................................................................................................................. 136
APPENDIX 3............................................................................................................................. 138
APPENDIX 4............................................................................................................................. 140

VII
Operator’s Manual
AutoLumo
CHAPTER 1 INTRODUCTION
1.1 System Description and Intended Use
1.1.1 System Description
System consists of an instrument and a control unit, of which the instrument

performs all the functions of the automatic sample and analysis operation, and the
control unit through the client software to control the instrument. The whole
automation process includes the patient sample information input to the test results
output.
1.1.2 Intended Use
Automatic Luminescence Immunoassay Analyzer is an in vitro diagnostic

equipment, based on the principle of magnetic particle chemiluminescence. The
device is used in conjunction with AUTOBIO's series magnetic particle
chemiluminescent reagents, can measure for qualitative and quantitative
determination of clinical immunization programs which derived from human serum,
plasma or other body fluid samples, including tumor markers, hormone, pathogen
antigen or antibody class project.
Contraindications: None
1.2 Manual Content
This manual is mainly for instructional purpose, to guide the completion of

equipment related operation and general maintenance. It includes the following
contents: a detailed description of the instrument features and general operating
concepts, specifications, operating principles of quality control, calibration functions,
operating techniques, emergency contingency measures, product marking and
maintenance measures.
1.3 Additive Supplies
AutoLumo A2000 Plus system provides the following additional documents:

An installation CD of Automatic Luminescence Immunoassay Analyzer;
A software operation manual;

1
Operator’s Manual
AutoLumo
1.4 Technical Support
If you want any technical support, please call our service hotline, [86]-400-056-9995,
or contact our service support representatives. For Any technical support, the series
number of instrument is necessary to provide.
1.5 Manufacturer
Autobio Labtec Instruments Co., Ltd.

No.199, 15th Ave, National Eco & Tech Zone, Zhengzhou 450016, China
Tel: [86]-400-056-9995
1.6 Service Provider
Autobio Diagnostics Co., Ltd.

Tel: [86]-400-056-9995
1.7 Product Information
Product Name : Automatic Luminescence Immunoassay Analyzer

Product Model : AutoLumo A2000 Plus
Production Date : Refer to the label
Service Life : 7 years (The service life of the instrument is related to the
operating environment and frequency of usage. Regular
maintenance can prolong the service life. If there is any
question, please contact with after-sales service provider.)
1.8 Precaution & Safety Symbol
1.8.1 Safety Features
The safety symbols on the instrument remind you of caution. Read contents of the
symbols and instructions of this manual carefully when running the instrument. If
any questions, please contact our technical service department of AUTOBIO.
2 AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

Operator’s Manual
AutoLumo
1.8.2 Protective Device
AutoLumo A2000 Plus has protective device inside to avoid the user from harm.
When open the upper cover of the instrument, the protective device will stop all
moving parts. If open the upper cover when the instrument is working, the device
will stop all movements in process.
1.8.3 Safety Symbol
In case of operating AutoLumo A2000 Plus not according to the accurate safe
operation procedure, there are some areas may cause harms to body or instrument
damages. In consideration of safety, we paste the below security symbols on these
areas.
CAUTION:
Please check 1.9.3 part of operator’s manual. When you see the following symbols
on the instrument, you can understand the meaning of those symbols.
Symbol Description
Remind you of reading important information on
the label or in Operator’s manual, or of noticing
potential danger existed along with another
symbol nearby.
General Warning Sign:

Attend the potential risk of electric shock,
especially for the high voltage parts, such as
Photomultiplier (PMT), and power module. It’s
too danger to open these parts for checking and
Electrical Safety: maintenance without trained professionally.
Indicate that there is the risk of infectious human
serum or blood products left on these areas of
the instrument or consumables & Accessories.
It’s necessary to clean these areas according to
Biological Hazard: the correct regulation of Lab or dispose of these
consumables & accessories according to local
official regulation.
Biological Risks.
Biological Risks:

3
Operator’s Manual
AutoLumo
Attend the sharp element which can hurt
operator. When running instruments, don’t put
your hand or any body parts in these areas.
Sharp Element:
Watch your hand when opening or closing the
cover of the instrument.
Crushing Of Hands:
Loading of reaction vessels can not exceed the

warning line. It may cause risks of abnormal
supply of RV.
Keep away from water: Keep away from water. Please reading
operator’s manual before operation.
Emergency Sample Position When the instrument is running, if there any

emergency sample, open the sample carrier
cover, put the sample carrier with emergency
samples into the position of this sign.
Show the Emergency Stop position. During the
Emergency Stop operating of instrument, if press the button, the
instrument will stop running.
Preorde & Turnplate Function In the state of ready for work or running, press
the button can change the reagent. See the
details of 8.3.1
Button
1.8.4 Biological hazards
The material derived from human, animal, tissue culture or in vitro culture must be
handled in accordance with the principles of potential infection risk. When dealing
with biological hazardous substances, operator should always wear suitable
protective outfit, such as approved disposable gloves, waterproof lab coats and
safety goggles. Handle biological harmful substances according to the process of
equipment biological hazards.
The following items must be carried out as potential biohazards substances:

Operator’s Manual
AutoLumo
All in vitro diagnostic equipment, pretreatment equipment, patient specimens,
serum based calibration reagents, quality control (QC) products and waste
materials.
Touch these potentially harmful biological materials: such as injectors, tubes, waste
containers, storage, sample needle, reagent needle, cleaning tank, reaction plate
cover, etc.
Users should contact the manufacturer if the instrument needs to be scrapped, and
it cannot be handled as a regular item.
1.9 System Configuration and Feature
1.9.1 Space Requirement
The size of the instrument & weight of each parts are shown in the below sheet.
Instrument：when the cover and drawer of the instrument are Length=1374 mm
closed Height=1200 mm
Width=950 mm
Instrument：when the cover and drawer of the instrument are Length =1374 mm
opened Height =1700 mm
Width =1530 mm
Ventilation , safe and efficient operation， maintenance Back=340 mm
space required Top=800 mm
Front=800 mm
Space requirement for System control flat (including outer Width=600 mm
computer and go-cart) Height=1700 mm
Depth= 950 mm
1.9.2 Weight of Instrument
Instrument without any consumables and accessories 390 kg

Computer Refer to
manufacturer
document
1.9.3 Performance Parameters
Name Automated Chemiluminescence Immunoassay

Analyzer

5
Operator’s Manual
AutoLumo
Assay method Magnetic particle chemiluminescent immunoassay
(CMIA)
Analysis method Stochastic analysis test
Number of samples A batch of 100 samples (can be cyclic appended),
there is a priority channel for emergency samples.
The number of analysis 24
items at one time
The number of reagent slots 24
Test speed 200 tests / hour
Add sample method Teflon needle (with liquid level sensing and clot
detection)
Sample carrier Sample rack (5 samples / rack)
Sample container Blood collection tubes, special sample containers
Sample handling capability 192 incubation position, five times magnetic
cleaning
Sample adding amount 5 μL-150 μL
Sample tube/cup 150 μL
dead volume
Sample dilution function Inner dilution (Maximum 500 times dilution)
RV(Reaction Vessels) Continue supply
supply
The fastest time of sampling 21 minutes
The slowest time of 40 minutes
sampling
Carry contamination carrying contamination rate of the sample needle
≤10-6
Repeatability Intra-batch measurement repeatability (CV，%）≤
8%
Linearity Intra-batch linear correlation coefficient (r)≥0.99
Stability The relative bias of 8h and 4h is not more than ±
10%
Data processing method Four parameters, linear regression, logit-log, point
to point
Sound pressure level Maximum sound power is 70 dB
Temperature scope of 4℃～10℃
reagent area
Temperature scope of Accuracy：37℃±0.5℃；
reaction area Fluctuation rate is no more than ±1℃ of central
value.

Operator’s Manual
AutoLumo
Pipettor precision Accuracy:50μl±2.5；Precision rate（50μl）： CV≤2%
CAUTION:
User must use the following accessories which are combined with instrument.
Accessories for safe operation of the equipment is described as follow:
Accessories Name Description

Reagent Supplied by Autobio Labtec Instruments Co., Ltd.
Power cord Supplied by Autobio Labtec Instruments Co., Ltd.
Reaction cup Supplied by Autobio Labtec Instruments Co., Ltd.
CAUTION:
Change of analytical performance of the device:
When a message of error or a change of result comes out, please contact our
service support engineer.
1.10 Environment Requirement
AutoLumo A2000 Plus has to be operated indoor, and the environment should
meet the following standards.
Temperature Normal Working Temperature: 10℃ ～30℃
Humidity, Normal Working Humidity：≤85%
RH (No agglutination condition) Optimal Working Humidity：50%～70%
Maximum altitude 2000m
Atmospheric pressure 85kPa ～106kPa
Brightness Avoid direct Sunshine and Ultraviolet light
Operating ambient temperature 2℃ per 30 mins
change rate
Pollution degree Based on EN 61010-1-2010, AutoLumo
A2000 Plus applies to the pollution degree:
class II.
Electromagnetic interference Far from Electromagnetic interference
Other instruments interference Far from instruments and equipments with
high power, strong amplitude, strong light
Water quality requirements Sterility deionized water: < 10 cfu/mL
Conductivity:≤5μs/cm （at 25℃）
Hydraulic pressure:50~340 kpa （0.5~3.4
kg/cm²）
Water consumption: 10L/h

7
Operator’s Manual
AutoLumo
1.11 Electrical Requirement
AutoLumo A2000 Plus has two separate power supply: one is for instrument and
the other is for outer computer, printer, etc. Each power should meet the specific
requirements.
1.11.1 Instrument
Power supply should meet the following requirements in order to protect the
instrument from damage：
Input power supply AC 100V—230V, 50/60Hz, Single phase
Power cord Attributes Special (only for power supply of
AutoLumo A2000 Plus)
Connector of Power cord AC 250V,10A
Plug of Power cord AC 250V,16A
Power cord 300/500V
Power cord length Less than 2m
Voltage Fluctuation No more than ±10%
Maximum resistance of Safety Grounding No more than 0.1Ω
between instrument and the laboratory
Overvoltage category II
CAUTION：
1) Please use Power cord which supplied by our company.
2) Do not replace Power cord of the instrument by inadequately rated cords.
1.11.2 Computer
Items Requirements
Processor Intel Pentium 4 1.8G
Internal storage 1G
Hard disk 80G
Safety certificate Compliance with CE certificate
CAUTION：

Operator’s Manual
AutoLumo
The computer should conform to the specification of current version of IEC/EN
60950 -1.
1.11.3 Power Consumption
PARTS POWER CONSUMPTION

Instrument 800 VA
Computer See computer manual
1.11.4 Standby Power（UPS）
No Standby Power Supply (UPS) provided along with AutoLumo A2000 Plus. If
required, the UPS with Local Earthing Isolator and Low Battery Indicator is
recommended. For more information about UPS, please contact our technical
support department.
UPS Configuration Requirement:
Minimum Power Output 2400 VA
Output Voltage 100-230V AC
Output Frequency 50/60Hz
Output Wave Sine Wave
Working time without load 1000 VA, 15 mins at least
Certificate CE
CAUTION：
If you need to disconnect all parts of the instrument, the power supplies to the
equipment and supplies energy should be disconnected firstly.
1.12 Installation
The AutoLumo A2000 Plus can be unpacked and installed only by authorized staff
or technical person of AUTOBIO. Do not take out the instrument from its package
without engineers presenting to the site.
Interconnection of instrument and other equipment：
Number Name Number Name

1 Instrument 2 The cover of instrument
3 PC 4 LCD
5 Instrument power input 6 Network port
7 Mains supply outlet with 8 Power cord

9
Operator’s Manual
AutoLumo
protective earth
9 Network cable 10 Input device
Interconnection instruction
CAUTION：
1) The ground of instrument installation position should be flat and hard, and its
bearing capacity is not less than 300kg/ ㎡ .The dimension for floor should be:
Length is not less than 1730 mm; Width is not less than 1380 mm.

Operator’s Manual
AutoLumo
2) The instrument must be installed at the position which is easy to operate power
and emergency braking switch.
3) Contact with professional engineers before transporting or moving the
instrument.
4) Make sure that the side shell must be completely installed before the instrument
is powered on.
5) Conductor which is easy to be accessed or may cause a shock hazard should be
grounding. Please connect the Power cord supplied by manufacturer to supply
mains with a protective earth.
6) Failing to comply with the usage specified by the manufacturer may cause
damage to the protective function of the instrument.
7) The instrument can be connected to the computer by communication cable.
Please refer to the label on the instrument and corresponding that on computer.
8) Before using the instrument, please use screwdriver, hex wrench to ensure that
all screws, fasteners are fixed tightly on the instrument.
9) During normal operation of the instrument, please ensure that all covers and
doors of the instrument are closed.
10) If the door and all covers of the instrument need to be removed, please
contact with the manufacturer. Service personnel or engineer will use specifie
d screwdriver, hex wrench to remove them.
11) Drainage systems equipments
Drainage systems parts Requirements

Height of waste solution discharge < 1m
Inner diameter of waste solution discharge ≧ 12mm
Length of waste solution discharging pipe ≦ 10mm
1.13 Warranty
AUTOBIO warrants that AutoLumo A2000 Plus delivered to you will be repaired in
accordance with the warranty provisions in the purchase contract for A2000 Plus or
reagents. Clients shall be responsible for execution of the protective maintenance
and cleaning procedures. If misfunction caused by fail of execution of the above
procedures within specified time, fees of repairment and spare parts shall be born
by clients.
The following situations are not covered by warranty.
1. Loss of Warranty Label on the instrument.
2. Instrument serial number is not provided by our company or has been altered.
3. Installation, Power supply and operation of Instrument & Accessories fails to
comply with this manual and its appendix.
4. Damages caused during delivery.

11
Operator’s Manual
AutoLumo
5. Damages caused by spattering of reagent, contact with corrosive substance or
air.
6. Instrument is disassembled or spare parts are changed by any unauthorized
personnel.
7. Damages caused by unclear internal voltage.
8. Damage caused by natural disasters or force majeure.
9. Software, hardware malfunction or damage caused by improper operation and
computer viruses, etc..
Free repairs shall be supplied by Autobio if there is any malfunction during the
warranty period. Autobio shall have the right to decide which spare parts should be
changed, and the warranty period of spare parts should be same with that of the
instrument.
Warranty service is non-transferable and does not apply for any defects caused by
misuse, changes, improper delivery or maintenance by unauthorized engineer.
CAUTION：
The Instrument is designed according to related standards, and substantially
conforms to EN 61010-1-2010 Safety Standards.
It’s safe to operate according to this Operator’s Manual. Don not try to make any
changes to the instrument, otherwise, the below results will happen.
• No more quality guarantee supplied by the manufacturer.
• Not complying with the requirements of EN 61010-1-2010 Safety Standards.
• Potential safety hazards.
AUTOBIO won’t be responsible for any damages or defects caused by using the
instrument for any purpose other than the intended purpose, or repaired by any
unauthorized person.
Use period of instruments associated with the instrument operation environment,
frequency of use, etc., and regular maintenance can prolong life.
If any questions, please contact the service provider.
Parts List:
NO. NAME Quantity Instruction for use
1 PVC tube 15m Used for connection between
distilled water and waste dilution, cut
to suitable length according to
installation situation at the site
2 Φ1×Φ3 0.5m Cut to suitable length according to
Silicone maintenance
tube
3 Screw lid 10Ps Use when instrument is In short of
screw lips

Operator’s Manual
AutoLumo
4 Fuse(2A) 2Ps Change when the fuse is damaged
5 Fuse(1.3A) 3Ps Change when the fuse is damaged
6 Liquid 1Ps Used for extra position distilled water
distribution bucket
1.14 Used in Combination with other Products
The instrument needs to be used in conjunction with the reagents of Autobio

Diagnostics Co., Ltd, please read reagent instructions carefully before use.
CAUTION：
If operation can not comply with the reagent instructions or attempting to use other
company's reagents, any report results and responsibilities arise from above action
will not be borne by AUTOBIO.

13
Operator’s Manual
AutoLumo
CHAPTER 2 SYSTEM SUMMARY
2.1 System Description
1) Structure and components: This product contains three parts: main instrument,
computer(Optional) and software. The main instrument is composed by sample
transportation system, sample adding system, reaction system, reagent storehouse,
test system, bar code reader, communication interface and power device.
2) Automobile A2000 Plus System has two major subsystems: Functional
instrument executing all sample process, & system control platform providing a
human-machine interface. Interactive operation will be available at the several
points as below:
⑴ Emergency Switch ⑵ Sample Loading ⑶ RV(Reaction Vessels)

platform supplies station
⑷ Sample Pipettor ⑸ Reagent Pipettor 1 ⑹ Reaction Tray
⑺ Reagent Carousel ⑻ Reagent Pipettor 2 ⑼ Photomultiplier(PMT)
⑽ Waste Solution ⑾ Wash Buffer ⑿ Distilled Water

Operator’s Manual
AutoLumo
⒀ Special Washing Solution ⒁ Solid Waste Container ⒂ LCD
⒃ Input Device ⒄ PC
2.2 System Status & Control
2.2.1 Status Indication
AutoLumo A2000 Plus has 4 Status Symbols at the left top of software interface.
They can be controlled by 3 control buttons at the right bottom of software interface.
Status Indication Description
Ready：System is ready to use
Running ： System is running. Assays are in progress and the

instrument is operating in certain process.
Pause ： No new assay added, but current assays are still in the
process.
Not Ready ： System is not ready for work. Execute system

initialization firstly to check subsystem status and initialize motor, or
reset the motive parts. Then, further operation can be continued
only.
2.2.2 System Shortcut Buttons
Total 6 System Status Buttons are colorless during the normal running of
instruments. View each Status interface by clicking each button. In the following
cases, the button will become red or yellow, the left amount of consumables reach
alert level, or unexpected problem with Sample processing, or event Logs error. The
buttons will return back to be colorless until these problems or alarms got solved.
Status Button Description Alarm Color
Access to “Abnormal Assay” lists RED indicates One or some
shown on sample management Abnormal Assays happened in
interface by clicking. View which process.
samples were detected abnormally. If
the list got cleared, the button will

15
Operator’s Manual
AutoLumo
become colorless.
Access to “Work Pending” lists shown YELLOW indicates some
on sample management interface by samples cannot be tested and
click. View which samples are waiting still wait in line due to some
in line for being tested. If the list got reason.
cleared, the button will become
colorless.
Access to “Reagent” management YELLOW indicates that the
interface by click, where listing which reagents need to load into
reagent and its calibration are lack. reagent carousel and their
assay calibrations need to be
added to the system.
Access to “Bulk” interface for Large YELLOW indicates Substrate
volume supply of materials by click, will get expired or one liquid
showing the left volumes of Substrate, waste container gets full.
Washing solution, dilution solution and RED indicates substrates are
reaction cup as well as the left space of empty or expired or waste
solid waste container and liquid waste containers are full.
container. If the residual availability
volume of consumables is at normal
level, the button is colorless.
Access to “Quality Control” interface by RED indicates that QC result
click, where we can set QC or check is not in the expected range.
the result of QC. If the results of QC are
normal, the button is colorless.
Access to “System LOG” interface by YELLOW indicates system

click, where we can find the system generate a common alert
LOG information, including malfunction event indicating that some
removal information of warning and situation needs immediate
alert event. After viewing the notice.
information, the button will become RED indicates the system
colorless. generates a serious alert
event indicating a serious
failure or error.
2.2.3 System Control Button
Control button Description

Operator’s Manual
AutoLumo
When system stays at RUNNING or PAUSE status, select the
button for stop test operation. The system will stop processing and
cancel the existing test by click the button.
System Status： Running Pause
STOP
CAUTION
When you select “STOP”, all test requests will be cancelled,
including the assay request waiting in line. Therefore, please
confirm what you selected again. After executing “STOP”, the
systems need to be re-initialized for the following assay operation.
When the system stays at RUNNING status, press for pausing test
operation. By click the button, no new test will start after the
scheduling test is completed. However, the sample in process will
be continued.
PAUSE System Status： Running
While system stays at READY or PAUSE status, Press
“RESTART”, test will be started or recovered. .
System Status： Ready Pause
NOTE
RESTART
At the system status of READY, Attend to the below situation:
Don’t restart the system while the amount of RV, the left space of
solid waste container, left volume of dilution and substrate reach
the alert level.
Make sure the left volume of dilution is sufficient, otherwise, dilution
adding operation can’t be executed during test.
Don’t restart until the temperature of Substrate, Reaction Tray and
Reagent Carousel reach to the normal range.
2.2.4 Other Buttons & Status Description
Return back to the home page
Directly into the test request interface

17
Operator’s Manual
AutoLumo
Directly into the test result interface
System HELP Description
1. Time Display
2. Temperature Display
Normal Warning Serious Warning
2.3 System Mode
Mode Description
LIS HOST QUERY MODE：AutoLumo A2000 Plus may be interfaced to a
LAB INFORMATION SYSTEM (LIS). Through the communication with
LIS, all the information of samples as well as assay requests can be
acquired by scanning the bar code of samples.
Enable method:[ System Setup] — [LIS Communication Setup] —
[Receiving LIS Requests]—[LIS Interface]—Select[Open]
STAND-ALONE MODE：All the information of sample and assay requests
needs to be input by hand on the operational interface.
Enable method:[ System Setup] — [LIS Communication Setup] —
[Receiving LIS Requests]—[LIS Interface]—Select[Close]
NOTE
Under LIS HOST QUERY MODE, system can read sample data and test request
information input by hand, and can acquire these information from LIS system.
WARM TIP
Operator’s Manual
AutoLumo
As for the samples which system failed to scan its barcode under LIS HOST
QUERY MODE, we may enter into STAND-ALONE MODE (LIS communication
must be set “OPEN” in system setting interface), and input these samples’ barcode
by hand into the systems. Then, Open LIS communication, and perform the
operation of acquiring LIS request. These samples information and assay requests
will be acquired from LIS system.
2.4 Shutdown & Restart
During the running process of AutoLumo A2000 Plus, you need to shutdown PC or
Instrument or both of them. Please follow the below steps of SHUTDOWN &
RESTART.
WARNING
The below steps have to be followed, otherwise, the potential damage may happen
to the instrument or system database.
2.4.1 Shutting down instrument for a while
System Status： READY NOT READY
CAUTION
Press switch on the left bottom of the instrument, the power (O position) will be off.
The main interface of software on PC shows that the status of system is “NOT
READY”. It means the instrument powers off.
2.4.2 Shutting down the PC
There are two options to shut PC down.

1. User interface (UI) software of AutoLumo A2000 Plus.
2. Keyboard of PC.
NOTE
1. Use the user interface (UI) to execute standard shutdown
2. In the condition of long time do not use the instrument, select “Instrument of
dormancy” on the interface of maintenance, make the instrument to enter power
saving mode.
WARM TIP

19
Operator’s Manual
AutoLumo
Keyboard for shutdown can only be used when there are no other solutions.
1. Simultaneously Press 【Ctrl】+【Alt】+【Delete】together
2. Select “SHUTDOWN”
3. Select one of option depending on whether you want to restart PC immediately
or not.
4. Select “CONFIRM” on the POP-UP window
5. If keyboard doesn’t work, please shut PC down by pressing Power Switch of
PC for 10 seconds at least. Restart PC only after 20 seconds.
2.4.3 Shutting down instrument for long time
In case of relocation of instrument or shutdown of instrument for more than 5 days,

Please shut AutoLumo A2000 Plus down. Before shutdown, please contact our
technical support team firstly.
WARNING
During the process of the above performance, it’s possible to touch the potential
infectious materials. Please dispose of these biological hazards strictly according to
the regulation of Lab. Attend to the protection of hand, eye and face especially.
NOTE
When the instrument shut down, the cooling of Reagent Carousel shut down too.
1. Run “ROUTINE CLEAN” program.
2. Take all the RV, sample tubes and racks out from Sample Supplies Unit and RV
supplies Station.
3. Unpack all reagents out from reagents Carousel, put them to 2-8℃ warehouse.
4. Clean large volume waste solution container.
5. Clean Solid waste container.
6. Shut the instrument and PC down, and turn the power off.
2.4.4 Sleeping instrument
In “SLEEP” mode, the instrument stays at low power consumption status, and only
provides the power to thermal insulation systems for keep working, and other parts
stop working.
1. Select “MAINTENANCE” on the main interface.
2. Select “SLEEP MODE” on the “MAINTENANCE” interface.
3. Select “CONFIRM” on the POP-UP window

Operator’s Manual
AutoLumo
2.4.5 Restarting instrument
When the power of instrument is off, follow the below steps to restart AutoLumo
A2000 Plus.
Facing the instrument, and move the bottom switch to I position.
WARM TIP
The system interface of software will stay at “OFF-LINE” status when the PC just
starts.
1. Make sure upper cover of the instrument is at “Closed” status.
2. Turn on the power switch behind the instrument and confirm that the
emergency stop button is at back-out status.
3. Please perform “RESTART” if the computer is not running and start AutoLumo
A2000 Plus system.
4. If the user interface software is running, perform "reinitialization" in the
maintenance interface
5. If the instrument fails to intialize, please contact with our Technical Support
Department
6. Don’t load samples or open the cover of the instrument until the internal
temperature of instrument reach the required level. Normally, it will take 15-20
minutes for the system to recover the temperature to the level required.
7. Make sure the system enters into “READY” mode. If the system cannot get
ready after 60 minutes, please contact technical support team.
8. “Wash substrate” is suggested after “DAILY CLEAN” at the first time. Then, run
the system regularly.
2.4.6 Restarting after long term shutdown
After long term shutdown, please restart AutoLumo A2000 Plus according to the
following steps.
WARNING
System Status： Not Applicable
1. Restart the instrument
2. Restart the computer and user interface software.
NOTE

21
Operator’s Manual
AutoLumo
1. It will take almost 1 hour for the system to recover the internal temperature to
required level because of long term shutdown.
2. Don’t load samples or open the cover of the instrument before the internal
temperature reaches the required level.
3. Make sure of sufficient washing solution supplies. If necessary, replace with
larger washing solution container.
4. Make sure of enough space of waste container left, and if necessary, clean waste
solution container and solid waste container.
5. Check the amount of RV, and if necessary, add more RVs to cup supplier deck.
6. Load new substrate
7. Load the required reagents
8. Perform “DAILY CLEAN”
9. Clean the solid waste.
2.5 Function Navigation
2.5.1 Test Analysis

Operator’s Manual
AutoLumo
Test Analysis I

23
Operator’s Manual
AutoLumo
Test Analysis II

Operator’s Manual
AutoLumo
Test Analysis III

25
Operator’s Manual
AutoLumo
2.5.2 System Parameter Setting

Operator’s Manual
AutoLumo
2.5.3 Maintenance and Diagnosis

27
Operator’s Manual
AutoLumo
CHAPTER 3 SPECIMEN OF PATIENTS
“Test & Analysis” icon on the main screen of AutoLumo A2000 Plus software
provides access to “Test & Analysis” interface. Select “Test Requests” there to the
functional areas for the specimen programming.
Interface Description:
NAME DESCRIPTION
Sample Rack Code Click “?” icon below the picture of Sample Rack on the left side
to activate the input box.
Position Fixed automatic numbering from 1 to 5.
Sample ID Sample bar code or Number.
Patient ID/Control Patient ID or control name.
Sample Type Sample types include：Serum, Plasma & Urine etc., totally 10
sample types.
NOTE: Currently, the instrument only supports serum, plasma
and urine, if you need to do sample tests of other types, please
contact our technical support team.
Dilution Factor Default Factor is “1”. It’s optional depending on your
requirement.

Operator’s Manual
AutoLumo
Comment Sample Description.
Auto Number Automatically numbering the following sample series No. once
initiating this function
Batch Requests In case that a number of samples request the same tests,
please select “Batch Request” function by ticking it, so that the
system will perform the same tests for all the loaded samples
automatically.
Close Exit the current screen and display its previous “Test &
Analysis” screen or directly back to the main screen if you didn’t
open “Test & Analysis” screen before.
Delete Rack Delete the current sample rack as well as samples’ information
involved. When the Sample Rack No. is not correct or void, the
icon is inactive.
Delete Sample Delete the current sample information as well as test requests
information it includes. When the sample doesn’t exist, the icon
is inactive.
Calibration Request Switch to “Request Calibration” interface.
QC Request Load Quality Control for tests.
Request from LIS Acquire the information from LIS.
Sample Details Show more information of the sample selected. If the sample
doesn’t exist, the icon is inactive.
CAUTION
1.Maximum 5 samples tube can be put into involved in each sample rack. Both
information of sample racks and samples are empty while entering into “Test
Requests” interface. Sample rack code need to be inputted by hand, once rack
code gets identified by system, samples information on the rack will be collected
automatically. If rack code cannot be identified, it will be regarded as a new one,
and the samples information have to be re-added.
2. Please note that the required sample volume must be greater than 150 μl.
WARNING
During loading and unloading of samples and reagents, operator must wear medical
glove to protect themselves from biological hazards.

29
Operator’s Manual
AutoLumo
3.1 Adding Rack and Specimen
1. Click “?” icon below the picture of Sample Rack on the right side to activate the
inputting column of sample Rack Code
2. Input sample rack code into the column, for example, “HZ01”, then, the sample
ID column is activated too. Sample ID can be input by hand or automatically by
scanning the sample rack bar code.
3. After entering the sample number 1, you can enter the name of the medical
record number/quality control product, setup the sample type, the external
dilution factor, and whether there is any comment, etc. First of all, enter the
name of the medical record number/quality control product.
4. Sample Type Setting: Serum
5. External Dilution Factor: 5
6. Add the sample comment by clicking “Comment” button. Input the sample
information to the pop-up window, and then click “OK” button. Thus, all the
information of sample rack and samples had been input into the databases.
7. Put the sample and sample rack to their position on Sample Loading Platform.
Then, Loading sample work is over.
CAUTION
1. Don’t make any difference to input the information of samples and sample
racks firstly or put the sample rack to its position on Sample Loading Platform
firstly before test start. But, if test started, it’s necessary to input the information
of samples and sample racks firstly, and then, put the sample rack to Sample
Loading Platform. Otherwise, the system cannot identify the samples added, so
that test request is pending, and the result will be marked as “No Test” after test
is over.
2. The Sample Rack Code inputted should be the same as actual Sample Rack
Code loaded.
3. To ensure the reliability of test results, please be sure to the volume of
remaining sample before starting, be supposed to the volume of remaining
sample ≥ 150ul (inherent volume flow rate of a sample cup) + the sample
volume actual tests need.
NOTE

Operator’s Manual
AutoLumo
1. Sample Rack Code is composed of Identification Code and Series Number,
which can be four or two characters. If the code is two characters, it should be
the digit figure from 01-99. If four characters, the first two characters should be
capital Letter, A-Z, and following characters should be the digit figure from
01-99.
2. Before inputting sample information, Sample ID has to be input firstly. Except
for Sample ID, other information is optional based on request.
3. Sample ID and Patient ID have to be composed by capital letter (A-Z) and digit
figure (0-9).
4. All the information of STAT samples is in RED.
3.2 Editing Patient Information
The procedure of editing patient information is similar as the procedure of editing

specimen’s information. Herein, briefly introduce the editing method according to
the “Patient Info” interface.
1. Select patient sample that you want to edit, and click “Sample Details (or F7)”
button. The “Patient Info” window will come out.
2. Edit all the patient information you want.
3. Click “OK”, then the new edited information will be saved automatically.
Click the “Sample Details” button again, the pop-up patient information is the saved
information.

31
Operator’s Manual
AutoLumo
3.3 Editing Test Request
Select “Test Request” for current samples. One or more tests can be carried out for
each sample.
1. Select the sample which needs test request.
2. Add test request in selection box of normative test or combination box and set
Dilution Ratio.
3.4 Deleting Sample Racks and Samples
1. Deleting sample
a) Input Sample Rack code in the column.
b) Select the sample that you want to delete.
c)
Click “Delete Sample” icon on the right side of interface.
d)
Click “confirm” on the pop-up window, then, the sample and the test request
information it included got deleted, Remove the samples from the sample
rack.
2. Deleting Sample Rack
a) Input Sample Rack code in the column.
b) Click “Delete Rack” icon on the right side of interface.

Operator’s Manual
AutoLumo
c) Click “confirm” on the pop-up window, then, the Rack and the sample
information it included got deleted.
d) Remove sample rack from Sample Loading Platform if necessary.
CAUTION:
The samples under the sampling line, the software will not be able to edit, nor can it
be moved or removed.
3.5 Requesting from LIS.
1. Load sample rack on the instrument.

2. Position each samples on Rack.
3. Input sample ID.
4. Select “Requests from LIS” icon.
5. The sample rack and the sample information it included will be covered after
click “yes”.

33
Operator’s Manual
AutoLumo
CHAPTER 4 SAMPLE MANAGEMENT
4.1 Requested
Enter into “Test & Analysis” screen from the main menu screen by clicking its icon,
and then select “Requested” button within the column of “Queue”. The sample
Status is displayed on the “Requested” screen, which test had been ordered and
scheduled for processing, but without being pipetted.
Screen Description
Button Name Definition
Close Exit the current screen and return back to its previous
(Labeled F12) screen of “Test & Analysis”, “Maintenance” and
“Diagnostic” or directly back to the main menu if you didn’t
open “Test & Analysis” interface before.
Find(Labeled F2) Search for a sample of specified Sample ID.
Edit Request (Labeled F3) Switch to “Test Requests” screen for editing the samples
selected.
Test Result (Labeled F10) Switch to “Test Result” screen.
Test Request (Label F11) Switch to “Test Request” screen for editing.

Operator’s Manual
AutoLumo
1. Find (Labeled F2)

Click “Find” icon, sample searching Dialog window come out, input the Sample ID
for searching.
2. Edit Request (Labeled F3)
Select the sample, and click “Edit Request” icon. Then, “Test Request” screen
comes out for editing the sample selected.
CAUTION:
Sample Rack Code and Sample Position cannot be edited unless being deleted and
inputted again.
4.2 In Progress
and then select “In Progress” icon within the column of “Queue”. The samples which
tests are in process are displayed on the “In Progress” screen.
Screen Description

35
Operator’s Manual
AutoLumo
Close (Labeled F12) Exit the current screen and return back to its previous
screen of “Test & Analysis”, “Maintenance” and
“Diagnostic” or directly back to the main menu if you didn’t
open “Test & Analysis” interface before.
Find(Labeled F2) Search for a sample of specified Sample ID.
Details (Labeled F3) Switch to “Test Requests” screen for editing the samples
selected.
Test Request (Labeled F11) Switch to “Test Request” screen for editing.
1. Find (Labeled F2)
Click “Find” icon, sample searching Dialog window come out, input the Sample
ID for searching.
2. Details(Labeled F3)
Select the sample, and click “Details” icon, then the details of selected sample
are displayed in the pop-up window, including test name, finished time, status,
mark and running speed.
4.3 Exception
and then select “Exception” icon within the column of “Queue”. The samples which
tests are exceptional are displayed on the “Exception” screen.

Operator’s Manual
AutoLumo
Screen Description
(Labeled F12) Analysis” screen or directly back to the main menu screen
if you didn’t open “Test & Analysis” screen before.
Clear All(Labeled F2) Clear all Exception Tests on the “Exception” Interface.
Clear Selection(Labeled F3) Clear Exception Tests selected.
1. Clear all exception tests:
Click “Clear All” icon, and then all exception tests get deleted.
2. Clear Exception Tests selected
Select exception tests you want to delete, and click “Clear Selection” icon. Then, the
selected exceptional tests get deleted.
NOTE
1. Information shown “Exception” interface include “Rack”, “Position”, ”Sample ID”,
“Exception test”, “Occurred Time”, “Flag”.
2. Refer to Appendix 1, the Description of “Fatal Flag” & “Non-Fatal Flag”.

37
Operator’s Manual
AutoLumo
4.4 Work Pending
and then select “Work Pending” icon within the column of “Queue”. The samples
which tests assay errors happened in process are displayed on the “Work Pending”
screen.
Screen Description
(Labeled F12) Analysis” screen or directly back to the main menu screen if
you didn’t open “Test & Analysis” screen before.
Clear All(Labeled F2) Clear all the work pending.
Clear Selection(Labeled F3) Select the work pending listed on the screen, and click “Clear
Selection” button. Then, the selected work pending is deleted.
NOTE
1. “Work pending” interface shows all tests which assay errors happened in
process, such as “CLT(Clot of sample pipettor)”, “QNS(Quantity of sample is

Operator’s Manual
AutoLumo
not sufficient )”,”Supply Wait(Supplies not sufficient)”,”No Test(No Test
Request)”.
2. “Work pending” icon will become yellow while “work pending” tests existed.
4.5 Daily Sample
Enter into “Test & Analysis” screen from the main menu screen by clicking its icon.
Click “Daily” icon, the “Daily” window come out with all the samples information
according to specified date.
Screen Description
(Labeled F12) Analysis” screen or directly back to the main menu screen
if you didn’t open “Test & Analysis” screen before.
Find(Labeled F2) Search for the specified sample with its Sample ID.
Details (Labeled F3) Show all the samples information on the day, including
Rack, Position, Sample ID, Patient ID/Control, Status, and
Completed Time.

39
Operator’s Manual
AutoLumo
NOTE
Sample Status: Done, In Progress, Exception
Completed time indicates the time for all the tests to be done. If the time cannot
be anticipated, the column will show “--”

Operator’s Manual
AutoLumo
CHAPTER 5 TEST RESULTS
Enter into “Test & Analysis” screen from the main menu screen by clicking its icon.
Then select one of the option icons listed on the column of “Test Results”, indicating
the type of result to review.
Screen Description
Close Exit the current screen and display its previous “Test & Analysis”
(Labeled F12) screen or directly back to the main menu screen if you didn’t
open “Test & Analysis” screen before.
Custom(Labeled F2) Determine which type of results’ information to show and display
sequence.
Filter(Labeled F3) Establish the filter condition, and filter test results.
Find(Labeled F4) Search the test results from filtered results according to specified
condition.
Details(Labeled F9) Show all the detailed information of selected test result.
Send to LIS(Labeled F6) Send the test result to LIS.
Print(Labeled F7) Print the test result out.
Refresh(Labeled F5) Refresh current test results.

41
Operator’s Manual
AutoLumo
5.1 Custom
Determine which type of results’ information to show. Click “Custom” button, and
select the desired options on pop-up “Custom setting” window as well as display
sequence. After click “confirm” button, the results display on the screen according to
Custom setting.
5.2 Filter
Click “Filter” icon to enter into “Filter” screen for setting of existed filter condition or
setup of new filter condition. After setting filter condition, click “confirmation”, the test
results will show on the screen according to the filter conditions selected or
established.
5.3 Find
Click “Find” icon to search the test results among filtered results according to
specified condition.
5.4 Details
Select the test result, and click “Details” icon or double-click current row for more
information of selected result, which will be displayed on the pop-up window.
5.5 Send to LIS
Select the test result, and click “send to LIS” icon to send the result to LIS.
5.6 Print
Print the selected test result out in report format. Click “Print” icon, and the results
will be printed as report form. Refer to description of “report form” section.
5.7 Update
Update the test results to the newest state, click the refresh button to update.

Operator’s Manual
AutoLumo
CHAPTER 6 CALIBRATION
6.1 Calibrator
Open “Calibrator Setup” screen by clicking its icon on the “Test & Analysis” screen.
Get access to “Test & Analysis” screen from The Main Menu.
Screen Description
Close(Labeled F12) Exit the current screen and display its previous “Test &
Analysis” screen or directly back to the main menu screen if
Add Calibrator(Labeled F2) Select it, “Calibrator” dialog window pop up for adding new
calibrator.
Edit Calibrator(Labeled F3) Select one calibrator, and click “Edit Calibrator” button. Then,
“Calibrator” Dialog window of selected calibrator pop up for
re-editing. “Edit Calibrator” button void without calibrator
selected.
Calibration(Labeled F5) Go to the calibration results interface

43
Operator’s Manual
AutoLumo
6.1.1 Add Calibrator
1. Press “Add Calibrator” Button, “Calibrator” Dialog window pop up for adding
new calibrator.
2. Scan or input the bar code of calibrators.

3. Scan or input the bar code of standards.
4. Click “OK” Button.

Operator’s Manual
AutoLumo
6.1.2 Edit Calibrator
1. Select the calibrator you want to edit, and click “Edit Calibrator” button to
display “Calibrator” Dialog window.
2. Scan or input the bar code of calibrator.
3. Click “OK” button.
6.2 Request Calibration
6.2.1 Enter “Request Calibration” Screen
Open “Request Calibration” screen by clicking its icon on the “Test & Analysis”
screen. Get access to “Test & Analysis” screen from The Main Menu.
CAUTION:
1. Each sample rack involves 5 samples at most, but one set of calibration
requests have 5-7 standards. So, it’s possible to load two sample racks for
calibration test.
2. In the selection of calibrator, only allowed to select the one which has the same
batch with its corresponding reagent.

45
Operator’s Manual
AutoLumo
Screen Description
Sample rack Code Click “?” icon below the picture of Sample Rack on the
left side to activate the inputting column of sample rack
code
Position Automatically number from 1-5.
Calibrator Fixedly mark calibrators from S0 to S6.
Test Times “Test times” is changeable. Qualitative assay calibration
can be executed 1-3 times, and each calibrator’s assay
times can be defined separately. Quantitative assay
calibration times can be executed 1-2 times, but, each
calibrator’s assay times have to be same. Default test
times for qualitative and quantitative assay calibration
are 2.
Comment Add the description of sample.
Item Name Differentiate different test items.
Lot Manufacture date of reagent
Expiration Expire date of reagent
Left times Left times of a reagent

Operator’s Manual
AutoLumo
Analysis” screen or directly back to the main menu
screen if you didn’t open “Test & Analysis” screen
before.
Add Times (Labeled F2) Click it once, Test times of selected calibrators will be
added by 1 time.
Reduce Times (Labeled F3) Click it once, Test times of selected calibrators will be
reduced by 1 time.
Select Calibrator Add the selected “Calibrator” information to “On Board
Reagents”
Delete (Labeled F4) Delete the current selected sample rack and its sample
information involved. When sample rack don’t exist, the
button void.
Save (Labeled F11) Save the newly added calibration to the system.
6.2.2 Add Sample Racks & Calibrators
1. Dispense each calibrator to sample tube.

2. Load these sample tubes on sample rack according to its series number.
3. Select the relevant reagents on board from “On Board Reagent” column.
4. Click “Select Calibrator” button.
5. Scan or input the code of sample rack with the calibrators selected for test.
6.2.3 Edit Request Calibration
1. Scan or input the code of first sample rack with calibrators which calibration
request needs to be edited on the inputting column.
2. Select the relevant reagents on board from “On Board Reagent” column.
3. Select the calibrators scheduled for test from “Calibration” column.
4. Click “Select Calibrator” button.
5. Scan or input the code of sample rack with the calibrators selected for test.
6.3 Calibration Result
Open “Calibration” screen by clicking its icon on the “Test & Analysis” screen for
reviewing the calibration results. Get access to “Test & Analysis” screen from The
Main Menu.

47
Operator’s Manual
AutoLumo
Screen Description
Close(Labeled F12) Exit “Calibration” interface
Filter(Labeled F2) Filter the calibration results according to the defined
condition.
Review Data(Labeled F4) Review the test data and calibration curve of selected
calibration item.
Calibrator Setup(Labeled F5) Enter into “Calibrator Setup” interface.

Operator’s Manual
AutoLumo
6.3.1 Filter
1. Click “Filter” button, Filter setting window pop up.

2. Select the filtering condition.
3. Select the method of sequence.
4. Click “OK” button.
6.3.2 Review Data

49
Operator’s Manual
AutoLumo
Select the calibration, and click “Review Data” button. Then, the “Review Data”
screen appears, including basic Calibration information, Calibration data and curve.
Screen Description
Basic Information 1, Basic information: “Test Name”, ”Reagent Lot”, “Calibrated Time”,
“Expiration”, “Unit”, “Curve”, “Status”, “Reason”, “Calibrator Lot”,
“Critical(cutoff)”
2, “Calibrated Time” means the finished time of Calibration Test.
“Expiration” is calculated from the calibrated time plus the effective
days, which can be set on ”Calibrator setup” interface.
3, Default options of “Curve” are “inactive” or “active”.
4, Default options of “Status” are “Passed” or ”Failed”.
5, “Reason” column includes the following options: “Standard
result %CV over valid range”(Judged by LD program), “Data
insufficient ” (Judged by LD program), “HCV”, “Bad Fit”, “Not Fit”.
Calibration Data 1,Include “Stated Concentration”, “RLU”, “1_SD”, “CV%”, “Calculated
Concentration”, “Flag”
2, Each test value for different time is shown on different row, and the
mean value is also shown below.
3, “No Value” display in case of no calculated concentration.
Calibration Curve “Curve” is drawn by the positions of calibrators on the graph based on
their concentration and RLU value (Qualitative Assay has no
calibration curve). X axis means concentration. Y axis means RLU
value.
Minimum/Maximum Values on X axis are defined as
minimum/maximum concentration value of calibrators.
Minimum/Maximum Values on Y axis are defined by test item
parameter graph.
Calibration curve is plotted according to curve fitting.
No calibration curve will be generated for qualitative Assay. So, no
curve existed.
Close(Labeled F12) Exit the current screen, and back to “calibration” interface.
Switch Active Curve Define the current Curve as active curve.
(Labeled F2)
Delete Failed Curve Delete the failed curve.
(Labeled F3)
Comment (labeled Add comment to the current calibrated curve.
F4)
Print (Labeled F5) Print the current calibration result, including basic information,
calibration data and curve.

Operator’s Manual
AutoLumo
Switch to previous calibration result.
Switch to next calibration result.

51
Operator’s Manual
AutoLumo
CHAPTER 7 QUALITY CONTROL
Quality controls are very critical to be tested to ensure the validity of calibrated
curve. The calibrated curve will become void for a while because of mechanical
wear or other factors. Through evaluation of quality control assays, the validity of
calibrated curve will get qualified.
User need to carry out quality control every day to ensure the test results is reliable.
7.1 Quality Control
Open “QC Setup” screen for managing QC by clicking its icon on the “Test &
Analysis” screen. Get access to “Test & Analysis” screen from The Main Menu.
Screen Description
Close(Labeled F12) Exit the current screen
Add Control (Labeled F2) Add new quality control to the system.
Edit Control (Labeled F3) Edit the current quality control
QC maintenance Setup the following values: Means Value (Target Value),
(Labeled F5) SD, Test Items and other basic data.
Quality Control (Labeled F6) Switch to “Quality Control” interface.

Operator’s Manual
AutoLumo
7.1.1 Add Control
1. Enter into “QC setup” screen, and click “Add control” button. The dialog window
of “Control” comes out for adding control information.
2. Input the following information of quality controls, Bar code, name of quality
control, Lot, Expiration, in case quality controls are not manufactured by
AUTOBIO.
3. Only input Bar code of quality controls that are manufactured by AUTOBIO.
4. Select the QC rule on dialog window of “Control”.
5. Click “Ok” button.
NOTE
QC Rule：
1. 1±2s (1-2s) – Flag when one point is more than 2 SD from the mean.
2. 1±3s (1-3s) – Flag when one point is more than 3 SD from the mean.
3. 2±2s (2-2s) – Flag when 2 consecutive points are more than 2 SD from the mean in
the same direction. Only the second point is flagged
4. 4±1s (4-1s) – Flag when 4 consecutive points are more than 1 SD from the mean in
the same direction. Only the fourth point is flagged.
5. 7x (7x) – Flag when 7 consecutive points are on the same side of the mean (for
example, 7 points are above the mean). Only the seventh point is
flagged.
7.1.2 Edit Control
1. Select “Edit Control” on the screen of “QC Setup”.

2. Select “QC Rule” included in the QC item.
3. Edit QC name

53
Operator’s Manual
AutoLumo
4. Click “OK” button for saving.
7.2 QC Maintenance
Click “QC Maintenance” button on the screen of “QC Setup”, and the screen of “QC
Maintenance” appears. Here, administrator privileges can maintain third-party QC.
Screen Description
Close(Labeled F12) Exit the current screen and back to the screen of “QC Setup”.
New(labeled F2) Add the new QC.
Delete(Labeled F3) Delete the current QC selected as well as its test items
included.
Add Item(Labeled F4) Add the selected item in the column of “Item Selection” to the
current QC
Delete Item(Labeled F5) Delete the selected item included in the current QC.
7.2.1 New Control
1. Enter into the “QC Maintenance” Interface, and click “new” button for adding
new control.

Operator’s Manual
AutoLumo
2. Input “Control number” & “Control name”
3. Select the first Item included in the new control under the column of “Item
Selection”
4. Select the relevant item on the column of “Control Number List”
5. Input “Mean” value & “SD” value
6. Select “Add Item” in case the controls include other items.
7. Repeat step 4 & 5 above
8. Repeat step 1 to 7 in case of adding more controls.
NOTE
1. “Control Number” has to be 3 digits number from 100-999.
2. “Control Number” doesn’t allow to be repeated.
3. “Control Number” & “Control Name” cannot be empty.
4. Control has to include one test item at least.
7.2.2 QC Request
1. “QC Request” Window is same as the window of “Test Request”. Refer to

CHAPTER 3 of this operator’s Manual for detailed information of EDITING
SPECIMEN INFORMATION.
2. Load the sample rack with controls.
3. Input its relevant position on sample rack to the screen of “Test Request”
4. Select one control Item in “Quality control Products” Panel.
5. Select one test in “Reagent” Panel.

55
Operator’s Manual
AutoLumo

Operator’s Manual
AutoLumo
7.3 QC Result
Open “Quality Control” screen for reviewing Quality Control results by clicking its
icon on the “Test & Analysis” screen. Get access to “Test & Analysis” screen from
The Main Menu.
NOTE
The color of normal Quality Control result is blue, but for abnormal or failed Quality
control result, the color will become red.
Screen Description
Analysis” screen or directly back to the main menu screen if
Filter(Labeled F2) Filter the quality control results according to the defined
condition.
Review Chart and data Review result data and QC drawing of selected Quality
(Labeled F4) control. The button void without selecting Quality control.
QC Setting(Labeled F5) Click to switch directly to the QC setting interface.

57
Operator’s Manual
AutoLumo
7.3.1 Filter
1. Click “Filter” button on the screen of “Quality control”, the dialog window come
out for filtering QC results.
2. Select filter condition.
3. Select “Sort Order”.
4. Click “Ok”.

Operator’s Manual
AutoLumo
7.3.2 Chart and Data
Click “Review Chart and Data” button for reviewing QC result and Diagram on the
screen of “Quality Control”.
Screen Description
Basic information of 1, Basic information：”Start Date”, ”End Date”, ”Control”, “Control Lot”,
Quality Control “Expiration”, ”Reagent Lots”, “Mean”, “SD”, “%CV”, “Data Points”.
2, “Mean”: Average value of all test datum involved in calculation.
“SD”: Standard deviation of all the tests datum involved in
calculation.
“%CV”: Coefficient variation of all the tests datum involved in
calculation.
“Data Point”: Records count that participate in calculation.
Test data list of 1, Verify the test data according to QC criteria selected. In case of the
Quality Control breach of QC criteria, the criteria breached will be marked in red or “*
*”. As for the breach of the criteria of “2-2S”,”4-1S”,”7X”, only the last
data is marked as invalid.
2, Test data list only shows the test results of quality control with data,
and only mark two QC results maximum which are out of range.
3, For Qualitative Tests, the data is “S/CO” Value (Actually RLU/cutoff

59
Operator’s Manual
AutoLumo
value). Others are concentration value.
QC Diagram 1, Levey-Jennings QC diagram shows a graph of all QC data tested.
2, Y axis shows Test Result Data. Range: -3S to 3S. Step:1S
3, X axis shows date from the beginning to the end. Step: 1 day. Only
31 days show on the whole screen. For reviewing the results of other
days, just click & button.

4, The horizontal grid values as 'x' and ±1, ±2 and ±3S, and the real
line show the mean value.
Close (Labeled F12) Exit the current screen and returns to “Quality Control” screen.
Filter QC Point Filter the QC results through “Date” and “Reagent Lots”.
(Labeled F2)
Delete QC Point Delete the QC Points selected.
(Labeled F3)
Ignore The QC point ticked as “ignore” won’t be used to calculate the SD
and %CV value, and the QC Diagram won’t show this QC point.
Print (Labeled F4) Print QC results, including QC basic information, test datum and QC
diagram.
Previous day
Next day
1. Filter QC Point: Filter the QC results through “Data” and “Reagent Lots”. The
condition of “Date” includes “all dates”, “Last week”, “Last month”, “Defined
Date (“Start day”, “End day”)”. The condition of “Reagent Lots” includes “All
Lots”, and “Each Reagent Lots”.
2. “Delete QC Point”: Only administrator User has the right to delete the QC point.
Password is required while common user wants to delete QC point.
3. “Ignore”: The QC point ticked as “ignore” won’t be used to calculate the SD
and %CV value, and the QC Diagram won’t show this QC point.
4. “Comment”: Add comment for QC point. The symbol of “ ” means the
relevant QC point has comment, and “ ” means the relevant QC point doesn’t
have comment.

Operator’s Manual
AutoLumo
CHAPTER 8 CONSUMABLE MATERIALS
CAUTION
1. The test result is unreliable when using expired consumable materials. Before
using reagent, please ensure the consumable materials is within its expiration date.
2. The lid of the reagent bottle need to be pricked before use .so that the reagent
can be pipetted normally.
8.1 On-Board Reagent
Select “Test&Analysis” in the main interface menu to enter the “Test&Analysis”

wizard window, and click “Reagent Supplies” button to check the reagent data on
the machine.
Screen Description
Button Name Description
Close (Labeled F12) Exit the current screen and return to “Test & Analysis” screen.
Change (Labeled F2) Execute the operation of replacing the reagent
Reagent Inventory Switch to the reagent manage menu
(Labeled F3)

61
Operator’s Manual
AutoLumo
Refresh(Labeled F5) Refresh on-board reagents
8.1.1 View the reagent data
1. Select the reagent slot on the graph.

2. The details information of the reagent display on the right side of the graph.
8.1.2 Change Reagent
1. Open the cover of the instrument.

2. Open the cover of the reagent supply deck
3. Load or unload the reagent you need, and then close the cover of the reagent
supply deck and the instrument successively.
4. Initialize the instrument, to make it in “Ready” state.
5. Click ‘Change’ button to switch to ‘prepare to change reagent’ window.
6. Active ‘On board reagent change completed’
7. Click ‘OK’ button in the ‘prepare to change reagent’ window.
8. The instrument will scan the new reagent. All the reagents on the machine will
be displayed in the ‘reagent list’ window.
1. Select “New Reagent” button to view the new reagent list.

2. Select “Unload Reagent” button to view unload reagent list.
3. Select “Prepare to change” button.

Operator’s Manual
AutoLumo
4. If the instrument cannot identify the bar code of the reagent correctly, you can
click “Manual Login” button to supply the reagent bar code manually.
5. Click ‘OK’ button.
8.1.3 On-Board Change Reagent
Appointment to change reagent can be initiated when the instrument is in the

status of “Ready” or “Running”. The instrument can enter into the status of “Reagent
Replacement” directly if the reagent replacement function was initiated in the status
of “Ready”. The instrument will enter into the status of “Pause” and stop adding
samples if the reagent replacement function was initiated when the instrument is in
the status of “Running”, meanwhile, count down for reagent replacement will be
showed on client software and Nixie tube of instrument. The instrument can enter
into the status of “Reagent Replacement” after the countdown is completed.
1. Press “Appointment” button for more than 3s in the status of “Ready”or
Running”
As showed in the picture：

63
Operator’s Manual
AutoLumo
2. Sampling will be paused after initialize ‘Appointment to change reagent’ function

and the expected time of changing reagent is displayed on the instrument.
As showed in the picture：
3. When the appointment indicator lights up, it is showed on Nixie tube that after
XXmins and XXs change the reagent.

Operator’s Manual
AutoLumo
4. When the count down showed on Nixie tube is not up to 00:00 , press the
“Appointment” button for more than 3s to cancel the online reagent replacement.
5. After reagent replacement is cancelled, the instrument is still in the status of

“Pause”, which requires user to click “Start” button to continue the test.

65
Operator’s Manual
AutoLumo
6. User can change the reagent when it is indicated on the customer software that
“The reagent on instrument can be replaced” and the countdown is up to 00:00.

Operator’s Manual
AutoLumo
7. Open the cover on left side of reagent tray to find the position for replaced
reagent or new reagent and put them into the tray.

67
Operator’s Manual
AutoLumo
8. Press “Rotate” button to turn reagent tray if the position for new reagent can not
be found in view. Press for once, the tray turn one-third of circle (eight reagent
position).
9. Bar code reading for slot number of the reagent can be started when the operator
clicks the ‘Appointment’ for more than 3s after the reagent being put into the tray
and cover being closed.

Operator’s Manual
AutoLumo
10. The reagent information will be showed on screen after scanning is completed.

69
Operator’s Manual
AutoLumo
11. If the slot number was scanned incorrectly, the indication will be showed on the
screen.

Operator’s Manual
AutoLumo
12. User can use hand-held bar code reader to scan the reagent and add reagent,
please refer to 8.1.2 for steps.

71
Operator’s Manual
AutoLumo
13. After scanning or replenishing of registering reagent completed, click
‘confirmation’ button and complete the reagent replacement.
CAUTION
1.‘Appointment’ function can not be initiated when the instrument is under the status
of ‘Reinitialization’, ‘Daily Clean’, ‘Daily Maintenance’, ‘Substrate Tube Washing’,
‘Implementing Diagnostic Function’and ‘Changing Reagent Kit’
2. Mixing the reagent adequately by manual before putting the reagent into tray
during On-Board Change Reagent.
8.2 Reagent Inventory
Select ‘Reagent Inventory’ button to enter reagent list management window from
the reagent management screen.

Operator’s Manual
AutoLumo
Note：
1. If the reagent is unload already, the slot will display ‘--’
2. If the reagent is expired or its calibration is expired, it will be displayed in red
color.
Screen Description
Close(Labeled F12) Exit the current window and return to the secondary menu (Test
& Analysis, maintenance and Diagnosis) or directly back to the
main menu if you didn’t open the secondary menu before.
Filter(Labeled F2) Set the filter factor to filtrate reagent records
Print(Labeled F3) Print filtrated reagents and their detailed information
Refresh(Labeled F4) Refresh on-board reagents
On-board Display all reagents on the machine
Reagent(Labeled F11)
8.2.1 Filter
1. Click ‘Filter’ button to enter the filter factor window.

73
Operator’s Manual
AutoLumo
2. Select filter factor

3. Select sort factor
4. Select sort direction
5. Click ‘OK’
8.3 Reagent Alarm
In the main menu, click the "reagent" on the interface to enter the reagent alarm
form, and check the reagent alarm information.

Operator’s Manual
AutoLumo
CAUTION
1. It indicates serious alarm if the button background is red and general alarm if that
is yellow
Interface Description:
Close Drop out the interface and return to secondary navigation interface
(Detect Analysis).
Reagent Inventory Return to reagent kit list management interface.
Reagents Tray Display all existing reagent kit.
Reagent Change Carry out the operation of reagent change on the instrument.
Enable/Disable Enable or disable the operation of reagent kit on the instrument.
Disenable Mixing Disenable reagent mixing function.
Enable Mixing Enable reagent mixing function.
8.3.1 Check The Reagent Alarm Information.
1. It will display details information while clicking the button which represents
reagent kit (If there is an exception, the abnormal information column is marked in
red or yellow). If there is alarm information for the reagent kit, the alarm information
will be automatically oriented in the list.

75
Operator’s Manual
AutoLumo
8.4 Bulk
Screen Description
Close(Labeled F12) Exit the current window and return to the secondary
menu (Test & Analysis, maintenance and Diagnosis)
or directly back to the main menu if you didn’t open
the secondary menu before.
Change Substrate(Labeled F2) Change the CLIA substrate.
Switch Substrate(Labeled F3) In the “ready” state, the active substrate and the
standby substrate can be switched back and
forth;Other states are not available
Add RV(Labeled F4) Place the reaction vessel to the cup supplier deck
Clean Solid Waste(Labeled F5) Change the bag contains wasted reaction vessel
Change Diluent(Labeled F6) Change the diluent liquid
8.4.1 Change Substrate
1. Select “Change Substrate” button switch to “Change Substrate” windows.

2. There are two types of substrate for AutoLumo A2000 Plus, select one of the

Operator’s Manual
AutoLumo
substrate displayed on the screen you need (if you change substrate II, click
the check box of substrate II displayed on the screen).
3. Scan or enter the bar code on the substrate bottles.
4. Open the cover of the instrument.
5. Take down the old substrate bottles and change into the new one. Put the old
substrate bottles into biological waste bags.
6. Install the new substrate bottle.
7. Close the cover of the instrument.
8. Click ‘OK’.
9. After change completed, instrument will wash pipe automatically.
CAUTION
1. The system will prompt user to change the substrate if the substrate is not
enough when running. At this point the instrument is no longer planning a new
test, but the current test will still continue.
2. Only in “Ready” state the ‘Change Substrate’ button is active, please flush
substrate pipelines carefully after the change operation.
Warning
In the process you will be exposed to potentially infectious materials, please
execute the standard laboratory procedures for handling and disposal the biological
hazardous material. Take appropriate methods to protect hands, eyes and face.
8.4.2 Add RV
1. Click ‘Add RV’ button, switching to "Add RV" dialog.

2. Open the top cover of the cup supplier deck
3. Add new reaction vessel.
4. Close the cover of the cup supplier deck and the instrument’s.
5. Click ‘OK’.
8.4.3 Clean Solid Waste
1. Click ‘Clean Solid Waste’ button, switching to "Clean Solid Waste" dialog.
2. Open the bottom cover of the instrument.
3. Take down the container of solid waste and put the waste into biological waste
bags
4. Install the container of solid waste.
5. Close the bottom cover of the instrument.
6. Click ‘OK’.

77
Operator’s Manual
AutoLumo
CAUTION
The operation of clean solid waste should be executed when the instrument is
power off, or the system is ready.
Warning
8.4.4 Change Diluent
1. Click ‘Change Special Wash’ button, switching to “Change Special Wash” dialog.
2. Open the top cover of the instrument.
3. Take down the old wash bottle and change into a new one. Put the old one into
biological waste bags.
4. Install the new bottle.
5. Close the cover of the instrument.
6. Click ‘OK’.
CAUTION
When doing dilution experiments, please make sure that dilution position has
placed sufficient diluent, if diluent shortage during the test, instrument will alarm
automatically, right now you need to add diluent manually, and click "change
diluent" in the interface of bulk, the system will detect automatically, and cancel the
alarm.

Operator’s Manual
AutoLumo
CHAPTER 9 SYSTEM SETTING
9.1 System Setting
Tip：System Setting requires administrator privileges

The default user is common operator, and you have to enter the password when
click system setting. Password is no need if login the software with administrator
privileges.
Screen Description
General Settings General Settings includes system identification, date,
time and language
Report Settings Set the header information of the report, the printer
selection and so on.
LIS Communication Settings Set the LIS Communication parameters
Administrator Password Reset administrator password
Backup Plan Set the data backup parameters
About Display the version information of the software
1. Click ‘Save’ after achieving the settings.
2. Click ‘Close’ if you want to cancel the changes.

79
Operator’s Manual
AutoLumo
9.1.1 General Settings
The default interface is the general settings when enter the system setting.
Screen Description
System ID Set the System identification (1-12 characters)
Language The Language of the software includes:
（Chinese(Simplified, PRC)-Chinese
（Simplified, PRC)、English-English)
Date Format Set the date format (YYY/MM/DD、YYY.MM.DD、YYY-MM-DD、

MM/DD/YYY、MM.DD.YYY、MM-DD-YYY)
Time Format Set the time format(24-hour and 12-hour）

Operator’s Manual
AutoLumo
9.1.2 Report Settings
Screen Description
Organization Set the name of organization
Laboratory Set the name of laboratory
Telephone Set the telephone number
Director Set the name of director
Report comment Set the comment of the test report
Printer Select the printer
Report Select report type, click “Format Adjustments” if it need to
change

81
Operator’s Manual
AutoLumo
9.1.3 LIS Communication Settings
Screen Description
LIS Interface【ON】 Open the LIS communication interface
LIS Interface【OFF】 Close the LIS communication interface
Auto send to LIS---Result Type Select send all results or close the function
Send mode Select the mode of send to LIS(By test or by sample)
Port Set the LIS communication interface(COM0、COM1、
COM2、COM3、…）
Baud Rate Set the Baud Rate of LIS communication interface
Date Bits Set the data bits of LIS communication
Parity Set the parity parameters of LIS communication
Flow Control Set the flow control of LIS communication
Stop Bits Set the stop bits of LIS communication
LIS communication path Set LIS export data location
2. Click ‘Close’ if you want to cancel the changes

Operator’s Manual
AutoLumo
9.1.4 Administrator Password
Screen Description
Old Password Enter the old password of administrator
New Password Enter the new password of administrator
Verify Reenter the new password of administrator
2. Click ‘Close’ if you want to cancel the changes

83
Operator’s Manual
AutoLumo
9.1.5 Backup Plan
Screen Description
Frequency Set the frequency of data backup(Daily or Weekly)
Start date Set the begin date of data backup(Monday, Tuesday,
Wednesday, Thursday, Friday, Saturday, Sunday)
Start time Set the start time of data backup(0-24 hour)
Next Backup Time Display the next time of data backup
9.1.6 About
Browse the version of the software.

Operator’s Manual
AutoLumo
9.1.7 Circuit Version Number
Within the permission of maintenance staff, the user can obtain the information of
version number and CanID number in client software.

85
Operator’s Manual
AutoLumo
9.2 Test Items
Note: It requires administrator permission to operate the test item.

Operator’s Manual
AutoLumo
Screen Description
Filter test list Display test information by filter
Filter(Labeled F2) Set the filter factor to filtrate the test
Edit (Labeled F3) Edit the parameters of test items.
Print(Labeled F4) Print selected test
Update (Labeled F11) Update test items.
Click ‘Close’ if you want to cancel the operation.
9.2.1 Filter
Click ‘Filter’ button to appear this window.

87
Operator’s Manual
AutoLumo

All Tests Enter the name and search in the all tests
Range True Enter the name and search in the enabled tests
False Enter the name and search in the disenabled tests
Sort Select the parameters for sorting test (Test name, Test
ID, Enabled, Default Sample, Units, Decimal Places and
Version.
ASC Tests will be list ascending according the filter
DESC Tests will be list descending according the filter
1. Click ‘OK’ to confirm filter or ‘Cancel’ to abolish the operation.

Operator’s Manual
AutoLumo
9.2.2 Edit
Screen Description
Name Display test item name and can not be edited
Full Name Display full name of test item and can not be edited
ID Edit test item ID number and the number range is from
100 to 999.The repeat test item number is not allowed
to enter.
Places Set the places number of the test results (0-5),
Basic Settings
exceeded the range will be handled by rounding up or
rounding down.
Units Set data units of the test results（IU/mL、mIU/mL、
NCU/mL、ng/dL、ng/mL、pg/mL、U/mL、μIU/mL、
pmol/L）
Enabled Set enable the test or not.
Normal Range Min The minimum value of the normal range.
Max The maximal value of the normal range.
Reference Range Set the reference range for printing the test result
(0-60 characters) in range1 to range 6
Note：Reference range will not be printed in the
current report.
Qualitative Gray upper Set the value equal to or higher than the critical value
Judgment Gray lower Set the value equal to or lower than the critical value
Less than Set the result when the result is less than the gray
gray lower

89
Operator’s Manual
AutoLumo
lower
judgment
result
Between Set the result when the result is in the gray range
judgment
result in
gray
More than Set the result when the result is bigger than the gray
gray upper
upper
judgment
result
Critical Range Critical Define critical value 1 of quantitative item.
(quantitative) value 1
Critical Define critical value 2 of quantitative item.

value 2
Less than Set the result when it is less than critical value 1.
critical
value 1’s
results
results Set the result when it is between critical value 1 and
between critical value 2.
critical
value 1
and critical
value 2
More than Set the result when it is bigger than critical value 2
critical
value 2’s
results
2. Click ‘Close’ if you want to cancel the settings.
9.3 Test Panel
Prompt：Test Panel requires administrator
privileges

Operator’s Manual
AutoLumo
Select ‘Test&Analysis’ in the main interface menu to enter the Test&Analysis wizard
window. Click Test Panel to enter this window.
Screen Description
New Create a new test panel
Delete Selected Delete the selected test panel
Save Save after modifying test panel content
Test Panel ID The ID cannot be changed if it is existed already.
Enabled Enabled the selected test panel or not.
Sample Type Select the type of sample.
Panel Name Enter a name for a new test panel or edit the name of an
existed test panel.
Optional Test Display all tests of current sample type
Selected Test Display the tests which are added into the test panel.
Add Add the test into a test panel(multi-test and repetitive are
allowable)
Remove Remove the selected test.
2. Click ‘Cancel’ if you want to cancel the changes.
3. Click ‘Close’ if you want to close the window.

91
Operator’s Manual
AutoLumo
9.4 Derived Results
Prompt：Derived Results requires administrator
privileges
This function is used to derive a new result through four arithmetic calculate
(addition, subtraction, multiplication, and division) according to one or more existing
test results. As a new test item, the test result will creat a new data in accordance
with derivation rules after patient sample is completed with all tests.
Screen Description
Derived Results Display the existing derivation result information.
Derived Name Set the name for derived formula.
Formula Units Set the units for the test results.
Enabled Enabled the selected Derived Formula or not.
Decimal Set the decimal place of test results (0-5), exceeded the
Place range will be handled by rounding up or rounding down.
Formula Enter or edit the derived formula.
Symbol The button for derived formula.

Operator’s Manual
AutoLumo
Test Item Display current tests item which can be selected.
Save As Save current formula, and edit a new formula.
Clear Formula Clear the formula.
Save Save current derived formula.
Delete Delete the selected derived test result

93
Operator’s Manual
AutoLumo
CHAPTER 10 MAINTENANCE
This menu provides some essential maintenance items for normal working of the
instrument, and please doing the maintenance step according to the menu. The
damage caused by improper maintenance is not guaranteed.
Select Maintenance button in the main menu to enter this window.
Note:
Some command buttons may be not displayed due to different management
privileges. If you want to adjust the items, please contact with our engineers.
10.1 Maintenance
Prompt：Maintenance of the three operation
requires administrator privileges

The maintenance menu includes Immediate Backup, Recover System and Clear
Historical data.
Instant Backup：

Operator’s Manual
AutoLumo
Backup the database to prevent data loss due to database corruption or misuse.
The backup path can be designated.
You can check the detail information about the database in ‘Backup’ command after
the backup is completed. It includes backup status, backup time and backup path.
See the figure blow.
Data Clear：
The historical data can be deleted in the Data Clear menu by selecting time and
data type. This operation should be careful as the data cannot be recovered.

95
Operator’s Manual
AutoLumo
Restoration：
Choose restoration and it will give a dialog box asking whether to recover the entire
system, select Yes or No. Recovery system will initialize the system, and therefore
the database backup should be carried out first to prevent database corruption or
data loss cause by incorrect content.
10.2 Clean
Daily Clean
Cleaning procedures should be performed by operator before starting the test every
day. Due to the substrate tip has preheating function, it is recommended to clean at
least 20 times before the start of the experiment.

Operator’s Manual
AutoLumo
Enter the times for washing and then click’ Perform Routine Clean’, the progress of
cleaning will be displayed at the below of the window. Do not try to finish the
process of the clean, to avoid database damage or failure of the operation.
Notice
The substrate may affect test results if it is in high temperature for a long time, as
the substrate tips have preheating function. The operation of substrate spit out
should be executed strictly.
Routine Clean
It is suggested to run the cleaning procedures after finishing the test every day. The
instrument should be cleaned in the longest idle date if your laboratory is continuing
to run.
Wash Substrate
Replacement of substrate in two ways:
1. When changing a different batch of substrate, first pull the substrate tube out from
the substrate bottle, then emptied at least 100 times, and wipe outside of the tube
with distilled water, followed insert the substrate tube into a new bottle, last flush at
least 100 times.
2. To change the same batch of substrate or if the instrument is idle for a long time,
please flush at least 50 times. See the figure blow.

97
Operator’s Manual
AutoLumo
10.3 Clean Inside
Clean inside once every three days by operator：

Turn off the instrument first.
Open the cover of instrument.
Wipe the sample deck, reagent deck and RV supplier station with a cloth dipped
water and neutral detergent.
Wipe the sample pipettor, #1 reagent pipettor, #2 reagent pipettor and substrate
pipettor with a cloth dipped grain alcohol.
Close the cover of the instrument after cleaning and checking the safety device is
normal.
10.4 Clean Outside
Clean outside once every three days by operator：

Turn off the instrument first.
Wipe the instrument housing with a dry cloth dipped neutral detergent.
WARNING

Operator’s Manual
AutoLumo
Acid and alkaline lotion is harmful to eyes and skin, please following the correct
laboratory procedures for processing.
Turn off the instrument before operation to prevent electric shock.
CAUTION
To ensure the accuracy of experimental results, suggest that change the sample
pipettor once every half a year, change the liquid pipeline once every half a year.
10.5 Debug
Sensor List:
Display port status of each sensor, convenient for you to troubleshoot and feedback
problems.
10.6 System
Shutdown:
In case of relocation the instrument or shutdown it for more than 5 days, please
close the software and computer.
Low Power:
In the condition of do not use the instrument for a long time, select instrument
hibernated to save energy. At dormant state, instrument cannot run testing.
Reconnect:
Restart software and computer.
Close software:
Close the software.
Reset system:
Perform initialization of the control system and the operating system in the state of
“Not Ready”. During the process, the instrument will not be able to operate.
Change role:
Different user permissions switch.
10.7 Reinitialization
When the instrument cannot work normal caused by fault or other problems, you
can reinitialize the software and the operating system. Select the items you need

99
Operator’s Manual
AutoLumo
and click reinitialization button. The default items are marked and you can change
them manually.
Notice
Before the reinitialization you should perform each needle returns to the initial
position, in order to reduce the risk of striker.

Operator’s Manual
AutoLumo
CHAPTER 11 TEST OPERATION
11.1 Preparation
11.1.1 Instrument Position Check
Open the front cover to confirm:

1. Open the reaction tray cover and confirm whether there is a reaction vessel on
the plate. If there is a reaction vessel, please clean it manually.
2. Confirm the SPP, RPP1, RPP2 and RPP3 is located above the washing station.
If they are not on the position, remove them manually.
3. Confirm that CE1, CE2 is located above the discarding vessel, CE3 is above
measurement position; If they are not on the position, remove them manually.
4. Confirm that all covers of reaction tray, reagent tray, instrument front and rear are
well closed.
5. Confirm that the emergency switch button is not pressed.
11.1.2 Reagent Check
1. Click “reagent” button to enter reagent alarm interface.

101
Operator’s Manual
AutoLumo
2. Check whether the reagent kit on RDT is sufficient for test, if not please add the
reagent.（Refer to chapter 8）

Operator’s Manual
AutoLumo
Notice:
 Be sure to remove the cap sticker from the newly added reagent.
 Confirm whether there is bubble in the new added reagent bottle. Please
remove the bubble by the sample gun if available.
 The reagent requires mixing for 30 minutes before test.
 Calibrate before use the new lot of reagents.
 Confirm the reagent change before test starts. The instrument will automatically
scan the reagent by click “Reagent Kit Change” (Refer to Chapter 8.1).
11.1.3 Chemiluminescent Substrate Check
1. Click the “Bulk” button and enter into “Bulk Supplies” interface

103
Operator’s Manual
AutoLumo
2. Check whether left count of Substrate I and Substrate II can meet the
requirements of test. Please add new substrate if they are not sufficient (Refer to
the section of 8.3.1).
Notice：
 Do not place the substrate A and substrate B in contrary. Please refer to the
color of bottle cap.
 Please check whether the pipette inside of the substrate bottle is bent and use
medical gloves to straighten it before place the substrate.
11.1.4 Consumables Check
11.1.4.1 RV Check
1. Click ‘Bulk’ button and enter into ‘Bulk Supplies’ interface.

Operator’s Manual
AutoLumo
2. Check whether the left count of RV can meet the requirements of test, if it is not
sufficient, please execute the operation of ‘Adding RV’
3. Check if there are enough RV in the RV container. Please add RV without delay
and execute the operation of ‘Adding RV’
Notice：
 The number of RV in the container can not exceed 1000 and the height can not
reach up to two third of the container.
 After RV is added to the container, operation of ‘Adding RV’ will be executed.

105
Operator’s Manual
AutoLumo
11.1.4.2 Wash Buffer Check

Check whether there is enough ordinary washing lotion and that in the system
washing lotion container. Please add without delay if lotion is insufficient.
Notice：
 Change the washing lotion before test if they are not used for a long period and
clean off the container.
 Test is suspended due to lack of washing lotion. New washing lotion should be
added before click ‘Start’ button.
11.1.4.3 Distilled Water
Check whether there is enough distilled water in the container. Please add if it is
insufficient.
Note: If there is distilled water equipment, manual adding is not required.
11.1.4.4 Liquid Waste Check
Please clean off waste liquid without delay if there are too much in the waste liquid
container.
Note: If there is waste liquid discharging pipe connecting to the instrument, manual
cleaning is not required.
11.1.4.5 Solid Waste Check
1. Click ‘Bulk’ button and enter into ‘Bulk Supplies’ interface

Operator’s Manual
AutoLumo

107
Operator’s Manual
AutoLumo
2、 Check whether the solid waste cabinet I and solid waste cabinet II are stacked
with solid waste. Please clean off the cabinets if full without delay and execute the
right side function of “Clean Solid Waste”
Notice：
Cleaning off the two solid waste cabinets while executing the operation of “Clean
Solid Waste” in the software.
11.1.5 Instrument Initialization and Daily Cleaning
1. Click ‘Maintenance’ in the software interface and enter into Maintenance

interface.
2. Click ‘Reset System’ and enter into reinitializaiton interface.

Operator’s Manual
AutoLumo
3. Click ‘Reinitialization’

109
Operator’s Manual
AutoLumo
4. It indicates ‘Ready’ after reinitialization is completed.
5. Execute ‘Maintenance’- ‘Daily Clean’-‘Executing Daily Clean’ in the

software.

Operator’s Manual
AutoLumo

111
Operator’s Manual
AutoLumo
11.1.6 Patient Test Request
11.1.6.1 Sample Pretreatment

Before the experiment, the sample should be pretreated and the pretreatment
should meet
the following requirements.
1. The serum is suitable for most test items, and some tests can only use serum,
and the
sample type is referred to the instructions of the kit.
2. Sample pretreatment is of great importance. The residul fibrous protain in the
sample, caused by improper mixing, agglutination time short, sample tube not being
placed up right and insufficient centrifugation, may lead to abnormal test.
3. Severe hemolysis, severe lipid blood, turbidity, flocculent or coagulant can not be
used, which will cause the magnetic particle to be unable to disperse effectively and
seriously affect the determination result.
4. Avoid cross contamination during sample operation and use disposable SPP or
sample injection tips.
5. The samples prepared by static separation method cannot guarantee the
accuracy of the results, and the samples need to be centrifuged.

Operator’s Manual
AutoLumo
6. Samples containing lipid stratification, blood clots, blood silk, protein groups or
silk should be centrifuged after removal of impurities.
7. The proposal sample centrifuge procedure:
 Keep the sample tube under incubation at 37℃ for 30 minutes(if incubation
condition can not be realized, keep separate gel tube at 20-30℃ ambient
temperature for no less than 30 minutes and general tube for no less than 60
minutes) and centrifugation at rotation of 3500-4000 rpm for 10 minutes at
least.
8. Sample intensified centrifugation process(Apply for high sensitive sandwich
method item)
 General tube sample : keep the sample under incubation at 37 ℃ for 60
minutes, then transfer 10000 g of the serum into centrifugation tube for 10
minutes and extract the upper serum for test.
 Pro-coagulation tube sample: keep the sample under incubation at 37 ℃ for
30 minutes, then transfer 10000g of the serum into centrifugation tube for 10
minutes and extract the upper serum for test.
 Anti-coagulation tube sample: transfer 10000g of the plasma into
centrifugation tube for 10 minutes and extract upper serum for test.
 RCF value is depended on rotation speed and radius gyration(r, calculated
by mm). The following formula can be used:
9. A sample containing lipids in the upper part after centrifugation need to be

transferred to the second sample cup or test tube, which should be carefully
manipulated to ensure that the sample does not contain lipid.
10. Check whether there is bubble in the sample. Remove bubbles by using
disposable SPP or tips to avoid cross contamination.
11. If there is any sample which contains blood clot, blood streak,protein group or
streak after centrifugation, repeat the centrifugation after remove impurities.
Note: Our company will not bear any liabilities caused by the abnormal test
result due to noncompliance with requirements of pretreatment.
11.1.6.2 Edit Sample

11.1.6.2.1 There are two options to enter into the interface of “Test Request”:

113
Operator’s Manual
AutoLumo
First: Click ‘Test Request’ on bottom left and enter into the interface.
Second: Click on main menu ‘Analyse Test’--‘Patient Test Request’ and enter into
the interface of ‘Test Request’

Operator’s Manual
AutoLumo

115
Operator’s Manual
AutoLumo
11.1.6.2.2 Edit Sample Information (Please refer to ‘Chapter 3 Patient Sample’ for
details)
1. Input sample rack bar code by Bar code Scanner or manual input
2. Input sample number in ‘Position’
3.Click required items and item name will displayed on left ‘Test Request’ area, it
means adding is successful; If the item is not required, click ‘Delete Request’ in
‘Test Request’ area.
11.1.6.3 Start to test
After completion of sample edit, put the sample rack into SRK and close the SRK
cover, click ‘Start’ button and start to test.
11.1.7 Daily Maintenance
Click on main menu ‘Maintenance ’- ‘Daily Maintenance ’- ‘Perform Daily

Maintenance’.

Operator’s Manual
AutoLumo

117
Operator’s Manual
AutoLumo
11.1.8 Close The Instrument
Power off the instrument and computer after test is completed (the power switch is
on the rear of instrument).

Operator’s Manual
AutoLumo
CHAPTER 12 DIAGNOSIS
Click ‘Diagnosis’ in the main menu entering ‘Diagnosis’ screen to facilitate your
check of system malfunction. The list below is instruction of each button, please
read in detail.
Buttons Description:
Close Close the window and return to the main window
Push Rack Push out the uninitialized sample rack in the fault status
Clean Incubation Units Clear away all reaction vessels in the reaction stage and
preachment tray.
Sampler Check Check the quantity, position and bar code of sample by
scanner inside.
Liquid Check The sample pipettor and reagent pipettor will detect the
liquid level of sample, reagent and diluent to check the
liquid detection function.
Quantitative Check The difference between the test value and set value is
measured by the balance to check dispense accuracy.
Reagent Check Scan the bar code of the reagent to check the information
and liquid level
Dark Value Check Check the dark value of the detection device with nothing

119
Operator’s Manual
AutoLumo
inside to confirm the dark value not exceeding the normal
range.
Light Source Check Check the repeatability of the light source
Pressure Test Check whether the sample pipettor is blocked
BF Test Perform the injection and suction test, to judge the washing
problems encountered
AUTOBIO Light Source Perform AUTOBIO light source test, to judge whether the
Check value of light is in compliance with the requirements.
Because this operation may cause damage to the PMT, it is
necessary for the professional to perform this operation.
Mixer Test Carries on the mixing test, to judge whether the mixing
motor is normal, the mixing intensity is suitable.
Liquid Level Calibration By sending the command to the control machine, the
detection difference of the liquid surface is obtained.
According to these differences, the current operation is
determined and the threshold value of the detection is
obtained
Report Test Click “PRINT” to print the test report
Note:
Please contact with engineers of AUTOBIO before diagnosis test, make sure
whether you can diagnose or adjust those projects or not.

Operator’s Manual
AutoLumo
CHAPTER 13 TROUBLESHOOTING
Simple troubles information and solution will be stated as follow, if there are any other
problems and errors, please contact with our engineer as soon as possible.
Error 1:
Description:
Reaction vessels is not enough or slide is blocked, please check immediately.
Overtime for supplying of reaction vessels, lacking of reaction vessels.
Error analysis:
1. Software—consumables—warning of lacking of RV.
2. There is not enough RV in the container.
3. Reaction vessels slide get stuck.
4. Reaction vessels slide inlet get stuck.
Solutions:
1. Execute steps from the software: “consumables”—”adding reaction vessels”
and click “OK”.
2. Supply reaction vessels into the container in time and click ”OK”.
3. Open the cover of the container, clear off the stuck vessels in the slide, and close
the cover, then click ”OK”.
4. Open the cover of the container, clear off the stuck vessels at the inlet of slide,
and close the cover, then click ”OK”.
Error 2:
Description:
The lip of the reaction vessels alignment device is open.
Error analysis:
The cover of reaction vessels feeder is not closed.
Solution:
Closet the cover and click “OK”
Error 3:
Description:
Click “OK”, it is displayed on the screen “Disable” for test.
Error analysis:
The cover of the sample loading device is not covered.
Solution:
Reclose the cover of sample loading device and click “OK”.
Error 4:
Description:
Sample line jam

121
Operator’s Manual
AutoLumo
Error analysis:
The sampling line sensor is misfired.
Solution:
After the test is finished, the instrument is reinitialized, and put into the new samples
and Click "OK" to start the test.
Error 5:
Description:
The user presses the emergency stop button on the instrument.
Error analysis:
The emergency stop button is pressed.
Solution:
1. Open the front cover of the instrument, clean off the waste reaction vessels.
2. Reclose the cover of reaction tray, remove each pipette tip and the transfer arm
to the home position.
3. Close the front cover, click emergency stop button.
4. Reinitialize the instrument, and reedit the sample, and click “OK” to start the test
again.
Error 6:
Description:
Front cover of the instrument is open, emergency stop.
Error analysis:
Front cover of the instrument is open.
Solution:
3. Close the front cover.
4. Reinitialize the instrument, and reedit the sample, and click “OK” to start the
test again.
Error 7:
Description:
Rear cover of the instrument is open, emergency stop.
Error analysis:
Rear cover of the instrument is open.
Solution:
3. Close the front and rear cover.

Operator’s Manual
AutoLumo
4. Reinitialize the instrument, and reedit the sample, and click “OK” to start the
test again.
Error 8:
Description:
Transfer arm 1 can not put up the RV in right place constantly for 3 times, please
check if there is any problems for RV alignment device or transfer arm 1 .
Error analysis:
RV alignment device or transfer arm 1 is abnormal.
Solution:
1. Please refer to Error 1 if RV supply is abnormal.
2. If RV supply is normal, click “PAUSE” button, after the testing items is completed,
reinitialize the instrument and start test again.
Error 9:
Description:
Buffer area is full of unloaded sample racks, please clear off the sample racks
unloaded.
Error analysis:
Buffer area is full of unloaded sample racks.
Solution:
Open the cover of sample loading device, take out of the sample racks from buffer
area and close the cover, click “OK” and continue the test.
Error 10:
Description:
The instrument is not initialized and can not be started for test.
Error analysis:
Start the test in the status of “NOT READY”
Solution:
Reinitialize the instrument and click “OK” to start the test.
Error 11:
Description:
The sensor for the distilled water can not work properly, please check.
Error analysis:
Distilled water is not full in the distilled water bucket in the limit time, the outer join
for distilled water is not enough.
Solution:
Supply the distilled water without delay.
Error 12:

123
Operator’s Manual
AutoLumo
Description:
This test is coming to an end, the sample management unit stops sample injection.
Error analysis:
The ongoing test is going to be completed. It is not permitted for sample injection.
Solution:
Click “OK” and continue the test after the ongoing test is completed.
Error 13:
Description:
When RPP1V driving toward downside, the RPP1V stays above RTT/ORTT while
the PTT/ORTT are turning, or RPP1V stays above RDTT while the RDTT is turning.
Error analysis:
The reagent carousel cover is not closed.
Solution:
Circumstance 1: “PAUSE” is displayed on the screen: After the ongoing test is
completed, close the reagent carousel cover and front and rear cover of instrument,
then reinitialize the instrument and continue the test.
Circumstance 2: “NOT READY” is displayed on the screen, test is stopped:
1. Open the front cover of the instrument, clear off the waste reaction vessels in the
reaction tray.
2. Close the cover of reaction tray again, move each pipettor pin and transfer arm
to HOME position.
3. Close the front and rear cover of the instrument and reaction tray cover.
4. Reinitialize the instrument and reedit the sample, click “OK” to start test.

Operator’s Manual
AutoLumo
CHAPTER 14 TRANSPORT AND STORAGE
14.1 Transport
The transport of the instrument should be avoided of moisture, water, excessive
vibration and extrusion. Handling, loading and unloading should be executed under
the guidance of professional engineers. Temperature range between -40℃ ~ +55℃,
and relative humidity is 5% -70%RH .
Essential information of symbols on instrument’s package as below:
Symbol Description
This symbol shall be accompanied by the
manufacturer's serial number.
Serial Number：
This symbol shall be accompanied by the name

and the address of the manufacturer
Manufacturer：
Authorized Representative In The This symbol shall be accompanied by the name
European Community: and the address of the authorized representative
in the European
Community
Keep away from sunlight: Please keep away from sunlight when transport
Please keep dry when transport
Keep Dry:
Contents of the transport package are fragile
therefore it shall be handled with care
Fragile:
Indicates correct upright position of the transport
package
This way up:
Transport package shall not be rolled
Do not roll:

125
Operator’s Manual
AutoLumo
Stacking of the transport package is not allowed
and no load should be placed on the transport
Do not stack: package
Temperature limitation： The upper and lower limits of temperature when
transport
Indicate the range of humidity to which the

medical device can be safely transport
Humidity limitation:
14.2 Storage
The instrument should be stored in a room with non-chemical, non-corrosive gas,
good ventilation, sanitation, temperature range between -40 ℃ ~ +55 ℃ , and
relative humidity is 5% -70%RH.

Operator’s Manual
AutoLumo
CHAPTER 15 EMC INFORMATION
EMC safety instructions：
a) AutoLumo A2000 Plus meets emission and immunity requirements of EN
61326-2-6:2013.
b) The equipment is in accordance with the class A equipment of CISPR11 design
and testing. In the family environment, the device may cause radio interference, the
need to take protective measures.
c) It is recommended to evaluate the electromagnetic environment before the use of
AutoLumo A2000 Plus.
d) Prohibit the use of this equipment in a strong radiation source (such as
non-shielded RF source) side, as it may interfere with normal operation of the
device.
Note 1: AUTOBIO has the responsibility to provide electromagnetic compatibility

information of AutoLumo A2000 Plus to customers or users.
Note 2: The user has the responsibility to ensure device's electromagnetic
compatibility environment, so that AutoLumo A2000 Plus can work properly.

127
Operator’s Manual
AutoLumo
APPENDIX 1
Fatal Flag
Flag Explanation Correction

1. For derived results, review each
test result used in the derived result
formula. If a result failed.
Troubleshoot according to the flag for
Caused by:
that result.
●The derived formula
2. Review the Event Log and
contains a test which cannot
troubleshoot according to the error
CCR generate a result.
events with a similar date and item to
●The system is unable to
this event.
calculate the result caused
3. Repeat test
by another error.
Repeatedly export all testing results
from the formula for a certain test.
4. If the problem persists, please
contact technical support.
1、Review the Event Log and
Detect clot in the sample events with a similar date and time to
CLT tubes or in the reaction this event.
vessel. 2、Repeat the test.
3、If the problem persists, please
contact technical support

Operator’s Manual
AutoLumo
● The test result locates at
the low dose position of the
curve for sandwich assay.
The results cannot be
1. Check the event close to the date
separated from the system
of the problem happened in the
error as the RLU or
"Event Log"
concentration is too low.
Please contact technical support.
IND ●The test result locates at
2. Run QC test (Quality Control), and
the low dose position or the
test again. Eliminate this error if the
high dose position of the
QC result is not in the normal range.
curve for competitive assay.
The results cannot be
separated from the system
error as the RLU is too low or
too high.
1. Follow the troubleshooting
instruction for the QNS event in the
The sample volume is Event Log.
QNS
insufficient. 2. Repeat the test(s).
The RLU value is exceeded
events with a similar date and time to
the acceptable
RLU this event.
illuminometer measuring
2. Repeat the test.
range.
troubleshoot according to the
error events with a similar date
A device error occurred
SYS and time to this event.
during processing.
2. Repeat the test.
When test culturing， 1. Regularly monitor incubator
incubator temperature is temperature until into the acceptable
outside the acceptable range.
TRI
range, it signs reaction stage If the instrument is to be restart, or
temperature exceeds the the cover of instrument is opened,
normal range. you need to wait at most 10 minutes,

129
Operator’s Manual
AutoLumo
so that the temperature returns to
normal.
If the system power is turned off for a
long time, then you need to wait at
most an hour, so that the temperature
returns to normal.
2. Repeat test when incubator
temperature reaches an acceptable
range.
3. If the temperature does not return
to normal, or if the problem persists,
please contact technical support.
1. Regularly monitor incubator
temperature until into the acceptable
range.
If the instrument is to be restart, or
the cover of instrument is opened,
you need to wait at most 10 minutes,
When test culturing，and
normal.
incubator temperature is
TRIH outside the acceptable
range, it signs reaction stage
most an hour, so that the temperature
temperature is too high.
returns to normal.
range.

Operator’s Manual
AutoLumo
1. If the instrument is to be restart, or
the cover of analyzer is opened, you
need to wait at most 10 minutes, so
that the temperature returns to
When the substrate is normal. If the system power is turned
allotted, and the substrate off for a long time, then you need to
temperature is outside the wait at most an hour, so that the
TRS
acceptable range, it signs temperature returns to normal.
substrate temperature 2. Repeat test when incubator
exceeds the normal range. temperature reaches an acceptable
range.
the cover of instrument is opened,
When the substrate is normal. If the system power is turned
allotted, and the substrate off for a long time, then you need to
temperature is outside the wait at most an hour, so that the
TRSH
acceptable range, it signs temperature returns to normal.
substrate temperature is too 2. Repeat test when incubator
high. temperature reaches an acceptable
range.
1．If the instrument is to be restart, or
cover of the instrument is opened,
normal. If the system power is turned
Reagent storage off for a long time, then you need to
TRR temperature exceeds the wait at most an hour, so that the
normal range. temperature returns to normal.
range.

131
Operator’s Manual
AutoLumo
cover of the instrument is opened,
normal.
Reagent storage
TRRH most an hour, so that the temperature
temperature is too high.
returns to normal.
range.
1. Please check the log to find related
When dispensing substrate,
events.
tests display abnormal
QSB 2. Change substrate.
because of lacking of
substrate.
1. Reasons undetectable caused
abnormal (unplanned shutdown).
Undetectable causes Please check the log to find related
ERR
abnormal test. events.
There is a lack of lotion or
1. Please check the remaining
QWB distilled water while the test
amount of lotion.
is in progress.
1. Check the amount of reagent
There is a lack of reagent remaining after the experiment.
QNR
when allotting reagent. 2. If the remaining amount is normal,
DRK High dark value. Please contact technical support

Operator’s Manual
AutoLumo
Non-Fatal Flag
Flag Explanation Correct operation

The calibration curve or Repeat the test, and recalibrate the
CEX
cut-off value expires. assay.
The abnormal RLU is 1. Whether the instrument is abnormal
REJ rejected, and it won't when make calibrate assay in the log.
participate in the calculation. 2. Recalibrate
The result is the test result Software is already automatically
OVD
after overrun dilution multiplied by the dilution factor.
The diluted result is less
than the dilute limit. It is not Without dilution, recommended to
OLR
suggested to do the dilute re-test.
test.
Test results of patients
This is a valid test result. No
CRH exceed the upper limit of the
corrective action is necessary.
critical range.
Test results of patients
CRL exceed the lower limit of the
critical range.
1. Please replace the substrate bottle.
EXS Substrate expires.
2. Repeat test.
For qualitative or
semi-quantitative analysis, This is a valid test result. No
GRY
test results or quality control corrective action is necessary.
results are in gray area.
1. Unload the expired reagent pack
The reagent pack lot is
LEX and load a new one.
expired.
2. Repeat the test(s).
The result is above the
ORH upper limit of the reference
range.
The result is below the lower This is a valid test result. No
ORL
limit of the reference range. corrective action is necessary.
The calculated 1. Review the Event Log for error
concentration is above the events with a similar date and
highest or most time to this event.
OVR
concentrated calibrator. This ●If events occurred, follow the
flag is only used for troubleshoot instructions.
quantitative and 2. Take one of the following actions:

133
Operator’s Manual
AutoLumo
semi-quantitative assays. ●If events occurred, and you
performed troubleshooting
procedures already, run quality
controls and then repeat the test.
-If the quality controls are in
range, and the result is reported
as greater than the value of the
highest calibrator (>X), you may
be able to dilute the sample. To
identify whether the assay allows
dilutions, refer to the product
instructions.
-If the quality controls are not
in range, follow the QC
troubleshooting instructions.
●If no events occurred, take one of
the following actions:
-If the result is reported as >X,
you may be able to dilute the
sample. To determine whether to
allow dilutions, see product
instructions. If dilution is allowed,
dilute and repeat the test.
-If dilution is not allowed, no
further action is necessary.
3. If you have questions about the
result or if the problem persists,
For the reagent box, the
1. Unload the expired reagent pack
stability time of open box
and load a new one. If the lot of the
has elapsed. When the
PEX reagent pack is different from the
system first puncture it,
expired one, recalibrate.
which has started testing the
2. Repeat test.
stability of the open box.
1. Check “QC Chart and Data”
interface，and find which rule not
The results of quality control
meet.
QCF violate one or more quality
2. Please operate according to the
control rules.
explanation of quality control
troubleshooting.

Operator’s Manual
AutoLumo
The final quality control of
sample tests lose control.
1. The project is out of control the last
（Regardless of any test
LQCF time. Suggest redoing control or
lose control, follow-up
calibration.
sample test result flag is
marked as LQCF.）
Lot of quality control expired, 1. Add a new lot number of quality
QEX which is valid only for quality control which is not expired.
control tests. 2. Repeat test.
The %CV of the standard 1. Repeat test.
HCV test result is beyond the 2. If the problem persists, please
scope allowed. contact technical support.
The results come from the This is a valid test result. No
DRX
derivation formula. corrective action is necessary.

135
Operator’s Manual
AutoLumo
APPENDIX 2
1. Product specific risks may affect service personnel and corresponding protective
measures for these risks:
Risk Module Protective Measures
(1) Waste liquid and discard Other 1. When repairing instrument, service
sample cup may cause personnel must wear protective mask
biological hazard to service and glove.
personnel
2.Service personnel should get a
professional pre-service training
(2) When repairing instrument Other 1. When repairing instrument, service

some hazardous liquid may personnel must wear protective mask
splash into eyes or mouth of and glove.
service personnel and cause
2. Service personnel should get a
biological hazards
professional pre-service training.
(3) When repairing instrument Other 1. Service personnel should get a

the moving part may cause professional pre-service training.
a machine hazard to service
2. Close the cover of instrument during
personnel
instrument working.
3.Add warning symbol on instrument
(4) The risks of crushing the Frame 1. Service personnel should get a
hand by the upper, front and professional pre-service training.
back covers.
2.Add warning symbol on instrument
(5) The power indicator may not ELEC 1. Before operating the electrical
lightened when the voltage cabinet, assure that the power switch is
is 12V, which may cause the off, the Power cord is cut off and the
risk of electric shock. instrument should stay out of operation
for 10 minutes.
2. Service personnel should get a
professional pre-service training.
2. Verify the safe state after repair:

(1) To check that the corresponding circuit is connected correctly, the connectors
are fixed tightly.

Operator’s Manual
AutoLumo
(2) To check the liquid pipes are connected to the pumps properly and the joints are
fastened by nylon wires tightly.
(3) To clear and fix the circuit and pipes without contacting and friction with moving
parts.
(4) To clean off the reaction cups and bolts left inside the instrument.
(5) To check and assure that the Power cord is not loose.
(6) To check and assure that there is no spark and abnormal smell caused by the
hot or burned wires in the power box of the instruments.
(7) Check and ensure all protective earth is fixed tightly in instrument.
(8) Check and ensure supply mains are fixed tightly.

137
Operator’s Manual
AutoLumo
APPENDIX 3
Sample Tube Barcode Requirements:
Support Barcode CODE 128 （Ordinary）、CODE 39、 NW7、 ITF、CODE 93
Type
Tube Type Height: 100 mm or 75mm；Diameter: 13mm
Barcode Length of Barcode：≤70mm（100mm Tube）；≤50mm（75mm Tube）
Dimension Width of Barcode：≥8mm；（Bar Height）
Requirements Bar Width：≥0.15mm；（Width of the thinnest bar）
Empty Area：>2.5mm，Suggestion 3mm；（The empty area at the two
side of barcode, See figure 1）
Width to Narrowness：≥2:1；（Ratio between wide bar and narrow
bar）
Barcode In case of scanning error, confirm that the empty area at the two edge
Scanning Area of barcode is more than 2.5mm. Stick the label aligning with center
line of sample tube.（See figure 2）
Barcode Quality Barcode should be clean, non-contamination, bar clear, straight and
unbroken(See figure 3: Incorrect Barcode).
Figure 1：Know the barcode
Figure 2：Paste Requirements

At the position of diagram①,
blank area should be left at the
edge of label. Meanwhile,
label should be pasted on
sample tube aligning with its
cntre line.
At the diagram② area, any
other information can not be
displayed in case of bar
skinning error.

Operator’s Manual
AutoLumo
Figure 3：Incorrect Barcode：

1. Barcode smearing or contamination
2. Barcode fading
3. Barcode line wavy
4. Barcode scratching
5. Barcode tilt
6. Blank in the barcode
Other factors may influence the barcode:
Print Contrast Signal PCS Value>=75%.

Optical index of barcode symbol. The bigger of PCS value, the
better of the optical characteristics. Low PCS value may result
distinguishing black and blank bars improperly.
Barcode Coat Barcode surface is coated with protective plastic after printing.
Requirements Mate coat is suggested. The barcode reader is same with
eyes. If the reflected light is too strong, the barcode can not be
read successfully.
Barcode installation Adjust by using of tooling.
distance At the distance of 35mm（from scanning window to barcode）.
（Service staff）

139
Operator’s Manual
AutoLumo
APPENDIX 4
Explanation
There are some English words or letter abbreviation on the instruments to indicate
name, position or usage. See the following details：
Noun Description
Indication computer or interface connecting with
PC
computer
POWER Power supply indication
ON Instrument Power on
OFF Instrument Power off
EM.STOP Emergency Stop Symbol
Emergency Position, indicating position of emergency
STAT
sample racks
CC Position of Common Wash
SC Position of System Wash Container
DW Position of Distilled Water Container
WL Position of Waste Liquid Container
SW1 Position of Solid Waste 1
SW2 Position of Solid Waste 2
DW-IN Distilled Water Inlet
WL-OUT Waste Liquid Outlet
SG1 Position of Substrate Group 1
SG2 Position of Substrate Group 2

Operator’s Manual
AutoLumo
AUTOBIO LABTEC INSTRUMENTS CO.,LTD
Tel: [86]-400-056-9995 [86]-371-6798-5313
Fax: 86 371 66780883

141

Autolumo Operation Manual

Uploaded by

Copyright:

Available Formats

Autolumo Operation Manual

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Autolumo Operation Manual

Uploaded by

Copyright:

Available Formats

What is the intended use of the AutoLumo A2000 Plus?

What is the intended use of the AutoLumo A2000 Plus?

What does the manual cover?

What does the manual cover?

OPERATOR’S MANUAL

AutoLumo A2000 Plus

AUTOBIO LABTEC INSTRUMENTS CO., LTD

© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

In Vitro Diagnostic Medical Device

This product is used for In Vitro Diagnostic Purpose.

Waste Electrical and Electronic Equipment (WEEE)

II AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

IV AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

VI AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

1.1 System Description and Intended Use

1.1.1 System Description

System consists of an instrument and a control unit, of which the instrument

1.1.2 Intended Use

Automatic Luminescence Immunoassay Analyzer is an in vitro diagnostic

1.2 Manual Content

This manual is mainly for instructional purpose, to guide the completion of

1.3 Additive Supplies

AutoLumo A2000 Plus system provides the following additional documents:

© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

Autobio Labtec Instruments Co., Ltd.

1.6 Service Provider

Autobio Diagnostics Co., Ltd.

1.7 Product Information

Product Name : Automatic Luminescence Immunoassay Analyzer

1.8 Precaution & Safety Symbol

1.8.1 Safety Features

2 AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

1.8.3 Safety Symbol

General Warning Sign:

© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

Loading of reaction vessels can not exceed the

Emergency Sample Position When the instrument is running, if there any

1.8.4 Biological hazards

4 AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

1.9 System Configuration and Feature

1.9.1 Space Requirement

1.9.2 Weight of Instrument

Instrument without any consumables and accessories 390 kg

1.9.3 Performance Parameters

Name Automated Chemiluminescence Immunoassay

© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

6 AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

Accessories Name Description

1.10 Environment Requirement

© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

8 AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1

1.11.3 Power Consumption

PARTS POWER CONSUMPTION

1.11.4 Standby Power（UPS）

Number Name Number Name

© AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1 AutoLumo A2000 Plus

10 AutoLumo A2000 Plus © AUTOBIO LABTEC INSTRUMENTS CO.,LTD . Rev.V1.1