eCL8000 User Manual A5

eCL8000
Fully Automated ECL Analyzer
User Manual
eCL 8000 User Manual Contents
CONTENTS
CONTENTS..................................................... 3 3.2. Installation Steps........................... 40
Foreword.......................................................... 3 3.2.1. Unpacking........................... 40
Overview...........................................................6 3.2.2. Carrying Method................ 41
Safety Classification....................................... 7 Chapter 4 Operating Instructions............... 42
Safety Precautions..........................................8 4.1. Overview.........................................43
Annex A Names and Contents of Toxic or 4.1.1. Operation Flow...................43
Hazardous Substances or Elements......... 20 4.2. Check before Startup....................43
Chapter 1 System Overview....................... 21 4.2.1. Device Connection Check 43
1.1. Product Description...................... 22 4.2.2. Printing Paper Check........ 43
1.2. System Specification.................... 22 4.2.3. Consumables Check......... 44
1.2.1. System Parameters...........22 4.3. Switch-on........................................45
1.2.2. Technical Parameters........23 4.3.1. Startup................................. 45
1.3. System Structure...........................24 4.3.2. System Initialization...........45
1.3.1. Pretreatment Unit...............25 4.4. Preparation before Operation......46
1.3.2. Incubation Unit................... 28 4.4.1. Confirmation of Device
1.3.3. Analytical Unit.....................29 States..............................................46
1.3.4. Liquid Line Unit.................. 30 4.4.2. Loading Reagents and
1.3.5. Connection of System Water Consumables.................................49
and Waste Liquid Lines................30 4.5. Calibration Operation....................52
1.3.6. Circuit Connection............. 31 4.5.1. Calibration Operation Flow52
1.3.7. Barcode Scanner............... 31 4.5.2. Preparation for Calibration
1.3.8. Display.................................32 Test..................................................52
1.3.9. System software................ 32 4.5.3. Calibration Operation........ 53
Chapter 2 Operating Principle.................... 33 4.5.4. Calibration Result.............. 54
2.1. Measurement Principles.............. 34 4.5.5. Execute Calibration........... 54
2.1.1. Sandwich Assay.................34 4.6. QC Operation.................................55
2.1.2. Competitive Assay............. 35 4.6.1. QC Operation Flow............55
2.2. Test Methods..................................36 4.6.2. Preparation for QC Test.... 55
2.3. Calibration Methods......................37 4.6.3. QC Operation..................... 55
2.3.1. Overview............................. 37 4.6.4. QC Result............................57
2.3.2. Quantitative Analysis.........37 4.6.5. QC Statistics.......................57
2.3.3. Qualitative Analysis........... 37 4.7. Normal Sample Test..................... 59
Chapter 3 Installation Requirements and 4.7.1. Operation Flow of Normal
Steps............................................................... 38 Sample Test................................... 59
3.1. Installation Requirements............ 39 4.7.2. Preparation for Sample Test59
3.1.1. Power Requirements.........39 4.7.3. Normal Sample Test.......... 59
3.1.2. Environmental 4.7.4. Sample Result.................... 60
Requirements................................ 39 4.8. Daily Maintenance........................ 61
3.1.3. Space Requirements.........39 4.9. Shutdown........................................61
3.1.4. Liquid Discharge 4.9.1. Shutdown............................ 61
Requirements................................ 40 4.9.2. Operation after Shutdown 61
1
eCL 8000 User Manual Foreword
Chapter 5 Data Transmission..................... 62 8.2.3. System Reagent.............. 110

5.1. Overview.........................................63 8.3. Test Sample Application............. 111
5.2. Connection with LIS......................63 8.3.1. Overview........................... 111
5.3. ASTM Communication..................63 8.3.2. Sample Application.......... 111
5.4. ASTM communication option...... 65 8.3.3. Test Start........................... 114
Chapter 6 Maintenance................................67 8.4. Results.......................................... 114
6.1. Overview.........................................68 8.4.1. Overview........................... 114
6.2. Maintenance Items........................68 8.4.2. Current results..................114
6.2.1. System Initialization...........68 8.4.3. Result.................................117
6.2.2. Clean the Liquid Channel. 69 8.4.4. QC Results........................121
6.2.3. Filling the Liquid Line of 8.4.5. Calibration results............ 123
Reagent/Sample Probe................69 8.4.6. Historical results...............125
6.2.4. Filling the Liquid Line of 8.5. Reagent........................................ 126
Aspiration probe............................ 69 8.5.1. Overview........................... 126
6.2.5. Preparing the Measuring 8.5.2. Reagent information........ 126
Cell.................................................. 69 8.5.3. Item information............... 134
6.2.6. Maintaining the Measuring 8.5.4. Combination reagent.......138
Cell.................................................. 69 8.6. Quality control..............................140
6.3. Scheduled Maintenance.............. 69 8.6.1. Overview........................... 140
6.3.1. Daily Maintenance............. 69 8.6.2. Quality Control Settings.. 141
6.3.2. Weekly Maintenance......... 70 8.6.3. Quality Control Statistics 146
6.3.3. Monthly Maintenance........ 71 8.7. Faults.............................................147
6.4. On-demand Maintenance............ 71 8.7.1. Overview........................... 147
6.5. Unscheduled Maintenance.......... 72 8.7.2. Current Fault.....................147
6.6. Maintenance Log...........................78 8.7.3. Fault Log........................... 149
Chapter 7 Alarms and Troubleshooting..... 81 8.8. System Application......................150
7.1. Overview.........................................81 8.8.1. Overview........................... 150
7.2. Alarm Classification...................... 82 8.8.2. System Setup................... 151
7.3. Alarm Level..................................... 82 8.8.3. System Status.................. 156
7.4. Fault- Category................................ 82 8.8.4. System Information..........157
7.5. Alarm viewing and Troubleshooting 8.8.5. Routine Maintenance...... 158
................................................................. 83 8.8.6. Advanced maintenance.. 160
7.6. Fault Code Table.............................. 84 8.8.7. Instrument statistics.........161
Chapter 8 Software Description................104 8.8.8. User Management........... 162
8.1. User Interface.............................. 105 8.8.9. Help....................................165
8.1.1. Main Interface...................105 8.8.10. About................................165
8.1.2. Pop-up Window..................106 8.9. Print............................................... 166
8.1.3. Message box.......................107 8.9.1. Overview........................... 166
8.2. System............................................107 8.9.2. Sample Results Print Report166
8.2.1. Overview.............................107 8.9.3. Quality Control Statistics
8.2.2. Main System Interface.... 108 Print Report..................................168
2
Foreword
Production Information
Prior to use of the product, please read the content of this manual carefully to
ensure proper use of the product.
After reading, please keep this manual properly for future reference.
Product Name: Fully Automated ECL Analyzer
Product Models: eCL 8000, eCL 8000i, eCL 8000p, eCL 8000x
Intended Use: This product employs the tris (2,2’-bipyridine) ruthenium(II)-based
direct ECL method, and is used in conjunction with matched test reagents; it is
clinically intended for qualitative or quantitative testing of analytes in human-derived
serum and plasma samples, including analytes of hormones.
Structural Composition: The device mainly consists of a material preparation
module (containing assay cups and sample racks), a liquid line module, a
temperature control module, a mechanical transmission module (containing a
reagent/sample probe and an aspiration probe), an optical path detection module
(containing a measuring cell), a circuit control module and software.
Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer Address: Unit A, 4th Floor, Building 15, Yijing Estate, No.1008
Songbai Road, Nanshan District, Shenzhen City, Guangdong Province,
E-mail: [email protected]
Manufacturing Date: See the label on the device
Useful Life: 5 Years
Revision Date: October 8, 2019
Version number：A5
Intellectual Property Rights

Shenzhen Lifotronic Technology Co., Ltd. (“Lifotronic”) owns the copyright of this
non-published manual and is entitled to treat it as confidential information. This
manual provides reference information only for operation, maintenance and repair
of the product. Lifotronic owns this manual and all related intellectual property rights
(including copyright). Without the prior written permission of Lifotronic, no one shall
use, disclose or allow any other person to obtain any information, in whole or in part
and by any means, of this manual, and no one shall perform photocopy,
reproduction, duplication or translation into any other languages, etc. of any content,
in whole or in part, off this manual.
 Lifotronic reserves the right of final interpretation of this manual;
 Lifotronic reserves the right to update product technologies without prior notice;
 Lifotronic reserves the right to change product specifications without prior notice;
 Lifotronic reserves the right to modify the content of this manual without prior notice.
3
is a trademark or registered trademark of Lifotronic.
Statement
This device must be used in conjunction with matched reagents produced by
Lifotronic.
Lifotronic does not provide any form of warranty for this manual, including but not
limited to any implied warranties of merchantability and fitness of the product for a
particular purpose.
Lifotronic will be responsible for the safety, reliability and performance of the device
only under the following conditions:
 The device is installed, operated, expanded, readjusted, improved and repaired by
persons authorized by Lifotronic;
 The device is used in accordance with the operating instructions;
 Relevant electrical equipment complies with applicable national standards.
Lifotronic will assume no liability for the safety, reliability or operation condition of the
device in any of the following situations:
 The service life of the product has expired and the product should be discarded as
useless;
 The components are disassembled, reassembled, stretched or re-commissioned;
 The product is not properly used according to the Instruction Manual.
Warranty and Repair Services

The warranty period of the product you have purchased is subject to the relevant
sales contract.
Consumables: Consumable materials that should be replaced after each use or
vulnerable materials that require periodic replacement. Consumable materials are
not covered as part of this warranty, while vulnerable materials requiring periodic
replacement have a specified warranty period.
The warranty period starts from the “Installation Date” filled in the Device Warranty
Card to which the warranty period is only subject. In order to protect your rights and
interests, please complete the Warranty Card after installation of the device, and
hand over Sheet II (Sheet “Kept by Lifotronic”) to the installation personnel or mail it
to Lifotronic’s Customer Service Department.
The following circumstances will void the warranty:
1. The customer fails to fill and send back the Device Warranty Card within 30 days
after acceptance of device installation;
2. The device SN provided by the customer is incorrect (we confirm whether warranty
service can be provided based on the device SN).
You are entitled to free after-sales services within the warranty period of your device;
however, please note that Lifotronic will only provide paid services and you are
required to pay the repair charges and cost of parts if the product requires repair for
any of the following reasons:
 Man-made damage;
 Improper use;
 Grid voltage beyond the range specified for the product;
 Force majeure events such as natural disasters;
 Replacement with or use of any parts, accessories or consumables not accepted by
Lifotronic or repair by any person not authorized by Lifotronic;
 Other failures not arising from the product itself;
Upon expiration of the warranty period, Lifotronic continues to provide paid services;
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If you delay or do not pay the payment for our paid services, Lifotronic will suspend the
repair services until you make the payment.
Contact
Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Address: Unit A, 4th Floor, Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan
District, Shenzhen City, Guangdong Province, 518055, P.R.China
Tel: 86-755-29060026
Fax: 86-755-29060036
Service Line: 400-888-6089
Web: www.lifotronic.com
Email:[email protected]
Authorized European Representative

Shanghai International Holding Corp. GmbH(Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Tel.+49-40-2513175 Fax.+49-40-255726
5
eCL 8000 Instruction Manual Overview
Overview
Overview
This manual describes in detail the purpose, functions and operation of the product.
Prior to use of the product, please carefully read and understand the content of this
manual to ensure proper use and optimum performance of the device and safety of
the operator.
Scope of Application
This manual is intended for reading by professional medical testers or trained
doctors, nurses or laboratory technicians. It enables user to:
 know about hardware and software of the product
 perform routine operations
 set system parameters
 carry out system maintenance and troubleshooting
Manual Introduction
This manual consists of 8 chapters. User can consult relevant chapters for desired
information.
Table 1 Contents of the Manual
Chapter Description
Chapter 1 System Overview Introducing the device in detail including
installation, hardware, software and system
specification of the device.
Chapter 2 Operating Principle Introducing the operating principle, test and
calibration methods of the device.
Chapter 3 Installation and Introducing the device installation
Commissioning requirements and steps.
Chapter 4 Operating Instructions Introducing the basic operation process of the
device.
Chapter 5 LIS Function Introducing LIS connection and parameter
setup of the device.
Chapter 6 Maintenance Introducing the requirements for scheduled
maintenance and on-demand maintenance of
the device, and provides the Maintenance
Record Forms.
Chapter 7 Alarms and Introducing the classification, view and
Troubleshooting handling of device alarms, and provides the
detailed list of fault codes.
Chapter 8 Software Description Introducing the interface and basic operations
of the software.
Intended Readers
The following professionals are intended readers of this Instruction Manual:
 Those who operate the system daily
 Those who maintain and troubleshoot the system
 Those who learn how to operate the device
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eCL 8000 User Manual Safety Classification
Safety Classification
This section introduces relevant safety protection information in this manual. Please
get familiar with the following safety symbols which are used throughout this manual
to remind you of some safety information.
Table 2 Safety Classification
Symbol Content Meaning
Alerts the operator to operate according to the

WARNING steps indicated by this symbol, otherwise
serious injury may be caused.

instructions indicated by this symbol, and
emphasizes important information in
ATTENTION operation steps or content requiring
operator’s special attention. Operation without
following the requirements may result in minor
injury or damage to the device.
steps indicated by this symbol, otherwise
Biohazard
there may be potential hazard of biological
infection.
7
eCL 8000 User Manual Safety Precautions
Safety Precautions
Introduction
For safe use of this device, please pay attention to all safety precautions below.
Otherwise serious or fatal injury may be caused.
 Only professional testers, doctors and laboratory technicians having been
trained by Lifotronic or any agency designated by Lifotronic are allowed to operate
and use this device;
 If any hospital or organization using this device cannot implement a reasonable
repair/maintenance plan, failure of the device may be caused and personal health
endangered;
 Ensure that the device is used under operating conditions specified in the
Instruction Manual. Otherwise the device may not be able to work properly,
measuring results may be unreliable, and its components or personal safety may
be damaged.
Prevention of electric shock

In order to prevent electric shock, please observe the following precautions.
 Unauthorized maintenance personnel are not allowed to open the housing of
the device in power-on state;
 Improper use of electronic devices may result in electric shock; only authorized
qualified persons are allowed to install, service and repair the device;
 Sprinkling of any liquid into the device may result in fault of the device or even
electric shock. Do not place any sample, reagent or other liquids on the device. If
any liquid sprinkles, please power off the device immediately and contact
Lifotronic’s Customer Service Department.
Requirements on operators
Operators must be professionally trained testers in medical and health
organizations and have acquired fundamental theories and basic operation skills
in clinical testing.
Importance of maintenance
Proper maintenance ensures the functional continuity and stability of the device.
Adjustment or omission of any maintenance steps described herein may result in
degradation of system performance and reliability.
Operating environment
The analyzer can be used in laboratory departments, central laboratories,
emergency departments, outpatient departments, laboratories of physical
examination center and other departments of medical and health organizations.
 This device is designed and tested as a Class A device specified in GB 4824. In
a home environment, this device may cause radio interference, against which
protective measures should be taken.
8
 It is forbidden to use this device near sources of intense radiation (e.g.,

unshielded RF source) for they may disturb normal operation of the device.
 This device is intended for use in industrial places; Prior to use of the device in
other environments, it is suggested to evaluate the electromagnetic compatibility.
Installation and maintenance

In order to avoid damage to the device during installation and maintenance, please
observe the following precautions.
 Only professionals authorized by Lifotronic are allowed to install or maintain the
device;
 For long-distance movement of the device, please contact Lifotronic in advance
to avoid problems caused by unauthorized movement;
 Only use parts provided or specified by Lifotronic.
Prevention of personal injury from moving parts

In order to avoid damage to the device during installation and maintenance, please
 Do not wear loose clothes or jewelries which may hook onto moving parts and
thus cause personal injury or infection or damage to the device;
 Do not touch any moving parts (e.g., reagent/sample probe, aspiration probe
and reaction tray) when the device is running;
 Do not operate the sample rack when the reagent/sample probe of the device is
moving;
 Do not operate the reagent kit when the aspiration probe of the device is
moving.
Doors/covers of the device

 Close the upper cover before starting up the device; be careful to avoid
pinching your hand;
 Always keep all doors/covers closed during operation;
 Observe relevant steps provided herein when opening the housing of the
device for repair.
Prevention of personal injury from laser

Do not look directly at the laser light emitted by the barcode scanner.
Prevention of fire and explosion

Since alcohol is flammable, extreme care must be taken when using alcohol near
the device in order to prevent fire and explosion.
Disuse of the device

During repair, transportation or disposal of the device, please clean and disinfect
the surface of the device and components posing the risk of biological infection
such as reagent/sample probe and aspiration probe, and relevant personnel
9
should be alerted of existing risks of the device in order to avoid biological or other
hazards during handling or repair.
Damage to the measuring unit

Do not open the cover of the measuring unit when the device is in power-on state;
otherwise the photomultiplier tube may get damaged.
Power-off
To disconnect the device from power supply, first shut down the Windows system
to avoid possible damage to the internal memory of the device.
Prevention of sample volatilization

If a sample has been placed on the sample rack for over 2h, replace it with a fresh
sample for retesting for volatilization of the sample during this period may lead to
error in results.
Impurities in sample
Any sample loaded onto the device must be free of any insoluble impurities; any
insoluble impurities in the sample such as fiber, dust or air bubbles may cause
inaccuracy of sample aspiration amount, thus leading to inaccurate results.
QC determination
 Before accepting a sample test result, check whether the QC result is within a
specific range. The QC frequency depends on system settings and requirements
of local regulations;
 Do not use expired reagents, calibrators or QC materials; otherwise the device
may give inaccurate results;
 Inaccuracy of measured results may result in misdiagnosis, thus endangering
patient safety.
Use of reagent
 Avoid direct contact with any reagent to avoid skin irritation or injury;
 Refer to the label on the reagent kit for special treatment guidance;
 Do not use expired reagents; otherwise you may get inaccurate results;
 Do not store immunological reagents at a temperature below 2℃; do not freeze
magnetic particles;
 Before loading any reagent onto the analyzer, ensure that the reagent is free of
air bubbles or air film which may cause insufficient pipetting volume, thus resulting
in inaccuracy of results.
Replacement of assay cups
10
Do not move the assay cups when using the device unless the device enters the
“Standby” or “Sample Injection Suspended” mode.
Replacement of sample rack

Do not move the sample rack unless the device enters the “Standby” or “Sample
Injection Suspended” state.
Replacement of pinch valve hoses

When replacing a pinch valve hose, care should be taken to avoid contact with
residual liquid in the used hose which comes from the measuring cell and poses
potential biohazards. Please wear disposable gloves. If the liquid accidentally
comes into contact with your skin, flush immediately with water; use disinfectants
as required by the laboratory, and seek advice from a doctor.
Replacement of immunological reagent

 The device must be in “Standby” mode when replacing the immunological
reagent;
 If you replace the immunological reagent during operation of the device, finger
pricking or other injury may be caused.
Replacement of system reagent

 The device must be in “Standby” mode when replacing the system reagent;
 If you replace the system reagent during operation of the device, finger pricking
or other injury may be caused.
Absence of alarm
When the device is running, there may be problems not detected during
monitoring, and the device will not generate an alarm to alert the operator. In this
case, a wrong QC result indicating that the device has this type of problems.
Possible causes of these problems include wear of component, leakage of liquid
line, contamination of reagent, etc. If such problem occurs, it should be decided to
continue testing the sample or terminate the operation depending on the possibility
of damage to the device or the severity of error in results.
Biohazard protection
In order to prevent harm to human body caused by biological infection, please
 Improper use of a sample may result in infection. Do not directly touch
samples, QC materials, calibrators or waste liquid of system reagent kits with your
hands;
 When operating the device, please wear gloves, work clothes and other PPE to
prevent infection;
 If any sample accidentally comes into contact with your skin, please treat it
according to the operating standard and seek advice from a doctor.
11
Disposal of waste liquid

 The content of the waste liquid storage container and water used for
subsequent cleaning of the container both have potential biohazards; contact with
waste solution may result in infection;
 Please dispose of all waste materials and relevant mechanical components of
the waste system in accordance with the device biohazard procedure; always use
appropriate PPE;
 When any waste solution comes into contact your skin, flush immediately with
water; use disinfectants as required by the laboratory, and seek advice from a
doctor;
 Please dispose of wastes in accordance with applicable local regulations on
disposal of wastes posing biohazards;
 If the device is connected directly to the drain pipeline, please dispose of
wastes in accordance with local regulations;
 Great care should be taken when disposing of Buffer solution and Auffer
cleaning solution because they may generate toxic gases;
 When filling waste liquid in the drain pipeline, keep the faucet open to ensure
that waste liquid is diluted thoroughly.
Prevention of electromagnetic interference
 The device conforms to the requirements on emission and immunity to

interference as specified in GB/T 18268.26; see Table 1 and 2 below;
 User is responsible for guaranteeing an EMC environment for the device so that
it can work normally.
Third party software

Do not install any third party software on the device control unit otherwise improper
operation of the system may be caused. Lifotronic does not recognize or allow the
installation or use of any third party software on the device control unit. Such
installation will void the warranty.
Data backup
 In the event of voltage dip due to power interruption during use of the device,
fault of the device control unit may occur, and system software, application
software and data may get destroyed;
 Fault or misoperation of the device may destroy result data or testing
parameters. To prevent this, result data and testing parameters should be backed
up on a regular basis.
Environmental protection
In order to avoid environmental pollution or personal injury caused by any waste
liquid or waste device, please observe the following precautions during disposal.
12
 Some substances contained in immunological reagents, QC materials,

calibrators, system reagents and waste liquids are subject to pollution regulations
and emission standards. Please observe the local regulations on emission;
 When disposing of any waste liquid, please wear gloves, work clothes and
other PPE to prevent infection, and wear safety goggles when necessary;
 When disposing of any waste device, please observe the local regulations on
waste disposal.
Prevention of chemical hazards

In order to prevent harm to human body caused by chemicals, please observe the
following precautions.
Great care should be taken during the use of system reagents which may cause
skin lesions to avoid direct contact with your body. In case of accidental contact
with your body, please flush immediately with water. In case of accidental contact
with your eye, please flush immediately with plenty of water, and seek advice from
a doctor.
Table 3 List of electromagnetic emission standards

Electromagnetic emission
Emission test Compliance
IEC/CISPR 11
Group 1
RF emissions
IEC/CISPR 11
Class A
RF emissions
IEC 61000-3-2
N/A
Harmonic emissions
IEC 61000-3-3
Voltage fluctuations / flicker N/A
emissions
13
Table 4 List of electromagnetic immunity standards

+ Electromagnetic immunity
Immunity test Basic Performance

Test value
item standard criterion
Electrostatic Contact: ±2kV, ±4kV
IEC 61000-4-2 B
discharge (ESD) Air: ±2kV, ±4kV, ±8kV
RF
electromagnetic IEC 61000-4-3 3V/m, 80MHz~2.0GHz, 80%AM A
fields
Power cord: ±1kV (5/50ns, 5kHz)
Burst IEC 61000-4-4 I/O signal line: ±0.5kV (5/50ns, B
5kHz)
Line-to-ground: ±2kV
Surge IEC 61000-4-5 B
Line-to-line: ±1kV
Power cord: 3V/m,
150kHz~80MHz, 80%AM
Conducted RF IEC 61000-4-6 A
I/O signal line: 3V/m,
150kHz~80MHz, 80%AM
Power frequency
IEC 61000-4-8 3A/m, 50/60Hz A
magnetic field
1 cycle: 0%; B
Voltage dips and 5/6 cycle: 40%; C
IEC 61000-4-11
interruptions 25/30 cycle: 70%; C
250/300 cycle: 5% C
Performance criteria:
A. The performance is normal within specified limits during test.
B. The function or performance is temporarily degraded or lost during test but can be
recovered automatically.
C. The function or performance is temporarily degraded or lost during test and needs
operator intervention or system reset for recovery.
Safety Signs and Silkscreen Prints

For safe use of this device, please pay attention to all safety precautions below.
Ignorance of these safety precautions may result in serious or fatal injury.
Symbol Meaning
Biohazard warning
This sign is provided on components of
the analyzer to indicate that the potential
hazard of infection exists nearby. Please
observe relevant safety measures of the
laboratory.
14
Moving parts
This sign is provided on any moving part
of the analyzer to indicate that it is not
allowed to touch this part in order to avoid
personal injury or damage to the device.
Laser Radiation
Do not stare into beam !
Corrosive substances
the analyzer to remind the operator of
wearing safety goggles and protective
gloves during operation due to the risk of
exposure to corrosive substances.
Prevention of probe collision
the analyzer to remind the operator of not
opening the cover during operation to
avoid damaging the reagent/sample probe
or the aspiration probe.
Danger! Be careful
Read Operating Instruction thoroughly.
Danger of electric shock by touching

inside of the analyzer
Use Front cover as shown
Fuse specification
USB port
Ethernet port
RS-232 Serial port
15
System water connector
Waste liquid connector
System water sensor
Waste liquid sensor
System water bucket
Waste liquid bucket
In vitro diagnostic device

For in vitro diagnostic use only
Batch code
Serial number
Use-by date
Date of Manufacture
Manufacturer
Authorized representative in the

European Community
Indicates this device is in compliance
with Europe Directive
Consult instruction for use
16
Compliance with WEEE Standard
Storage temperature
Card swiping symbol
a.c. Alternating current
Protective earthing
Main Unit switch
Refrigeration switch
Keep upright
Fragile
Pay attention to the rain
Prohibit the rolling
Limit of stack layers
17
*Warning Labels and Meaning：

Symbol Location Meaning
1. Do not use alcohol and other organic
Front cover
solvents to wipe.
2. There are light sensitive devices In the
measuring unit,In order to prevent damage，
it is forbidden to open the cover plate for
the measuring unit in the energized state；
3. The measuring cell belongs to
consumables,Replacing on an annual basis or
after 20,000 tests；
See 6.5.Unscheduled Maintenance
Left lower
corner of
measuring
unit cover
The pinch valve hoses belongs to

consumables，Replacing when it has been used
Liquid Unit for 3 months or is obviously damaged；
（Near pinch
When replacing the pinch valve hoses, please
valve）
wear gloves to prevent infection；
See 6.5.Unscheduled Maintenance
1. Consult instruction for use；
System water 2. When connecting the waste liquid
and Waste pipeline, please wear gloves, work clothes
liquid and other PPE to prevent infection；
connector See 1.3.5.Connection of System Water and
Waste Liquid Lines
1. Consult instruction for use；
The label on 2. Please dispose of wastes in accordance
the device with applicable local regulations on
disposal of wastes posing biohazard；
18
19
eCLuser Manual Appendix A
Annex A Names and Contents of Toxic or

Hazardous Substances or Elements
Toxic or Hazardous Substances or Elements
Part
Pb Hg Cd Cr (VI) PBB PBDE
Robotic arm
○ ○ ○ ○ ○ ○
assembly
Reaction tray
○ ○ ○ ○ ○ ○
assembly
Immunological
reagent
○ ○ ○ ○ ○ ○
refrigeration
assembly
System reagent
temperature ○ ○ ○ ○ ○ ○
control assembly
Measuring
○ ○ ○ ○ ○ ○
assembly
Rack ○ ○ ○ ○ ○ ○
Syringe assembly ○ ○ ○ ○ ○ ○
Metal housing ○ ○ ○ ○ ○ ○
Plastic housing ○ ○ ○ ○ ○ ○
Water pump,
○ ○ ○ ○ ○ ○
solenoid valve
Pipeline and
○ ○ ○ ○ ○ ○
joints
Circuit board × ○ ○ ○ ○ ○
Motor ○ ○ ○ ○ ○ ○
Wires ○ ○ ○ ○ ○ ○
○: Indicates that the content of this toxic or hazardous substance in all homogeneous materials of the
corresponding part is below the limit specified in ROHS 2011/65/EU.
×: Indicates that the content of this toxic or hazardous substance in at least one homogeneous material of
the corresponding part is above the limit specified in ROHS 2011/65/EU.
20
eCL 8000 User Manual Chapter 2 Operating Principle
Chapter 1 System Overview
 1.1 Product Description

 1.2 System Specification
 1.3 System Structure
21
1.1. Product Description

eCL 8000 Fully Automated ECL Analyzer is a small-sized fully automated
immunoassay analyzer for clinical use. This device employs the tris (2,2’-bipyridine)
ruthenium(II)-based direct ECL method, and is used in conjunction with matched
test reagents. It is clinically intended for qualitative or quantitative testing of analytes
in human-derived serum, plasma and other samples, including analytes of
hormones. Compact and portable, the device can be placed on a workbench, saving
laboratory space. Information of all analytical reagents, calibrators and QC materials
matching the device can be automatically input into the software. The device
consists of an analytical unit and a control unit. The analytical unit has such
functions as adding samples and reagents required for fully automated
immunoreaction and analysis, automatic scanning of patient samples,
electrochemical measurement, result transmission, etc.. The control unit controls
the analyzer to input and output data, evaluate results, calibrate the device and
complete quality control.
1.2. System Specification

1.2.1. System Parameters
Table 1-1
Dimension and weight
The dimension and weight parameters of the device are listed
below.
Dimension L: 650cm
D: 620cm (765cm when the touch
screen is opened)
H: 650cm (1050cm when the upper
cover is opened)
Weight Net weight: 100Kg
Table 1-2
Operating conditions
Device’s operating conditions:
Power supply AC 100-240V 50/60Hz
Rated input power 800VA
Ambient temperature 10℃~30℃
Relative humidity <80% at 30℃, non-condensing
Atmospheric pressure 75kPa~106kPa
Altitude ≤2000m
Table 1-3
Storage conditions
Device’s storage conditions:
Storage temperature 0℃~55℃
Relative humidity <93% at 40℃, non-condensing
22
Table 1-4
Safety classifications
Device’s safety classifications:
Overvoltage category Category II
Class of pollution Class 2
1.2.2. Technical Parameters

Table 1-5
Main performance indicators
Device’s main performance indicators:
Accuracy and fluctuation Accuracy ≤±0.5℃
of reaction tray
temperature Fluctuation ≤±1.0℃
Stability of analyzer ±10%
Within-run repeatability
≤8%
of clinical items
Linear correlation of
≥0.99
clinical items
Residual contamination
≤10
-5
rate
Pipetting accuracy error ±5%
Variation coefficient ≤2%
Table 1-6
Pretreatment unit
Parameters of the pretreatment unit:
Sample positions ≥30 sample positions
Supporting sample and reagent level
Liquid level detection
detection
Probe blockage Supporting detection of probe
detection blockage by sample
Special reagent ≥ 10 reagent positions, supporting
cartridge magnetic bead blending
Temperature of special
4℃-15℃
reagent cartridge
Table 1-7
Analytical unit
Parameters of the analytical unit:
Tris (2,2’-bipyridine)
Reaction system ruthenium(II)-based direct ECL
method
Testing speed 86 tests/h
Reagent detection Supporting reagent level detection
Reagent cartridge
28±2℃
temperature control
Table 1-8
Incubation unit
23
Parameters of the reaction system:

Disposable assay cups, 100 assay cup
Assay cups
positions
Reaction temperature 37±0.5℃
Table 1-9
Software operating environment

Parameters of the control unit:
Processor Intel J1900
Memory 2G DDR3 1600MHZ
Hard drive 32GB MLC NAND Flash
System software Windows 7
Database software SQL Server 2008
Operating environment vcredist2010,
software .net framework4.0
Software Version 00.00.03
1.3. System Structure

The device consists of a pretreatment unit, an incubation unit, an analytical unit, and
a liquid line unit.
Fig. 1-1 Device structure
24
Fig. 1-2 Ports on the back of the device
1.3.1. Pretreatment Unit

The pretreatment unit is on the left of the device, consisting of a 3D robotic arm, a
special reagent cartridge, a sample cartridge, and a cleaning cell. The 3D robotic
arm aspirates reagent and sample respectively from the multi-component kit in the
special reagent cartridge and the sample tube in the sample cartridge, and then
injects them into the assay cups.
Fig. 1-3 Structure of pretreatment unit
25
Reagent/sample probe
The reagent/sample probe is used to aspirate reagent or sample to be
tested.
Fig. 1-4 Structure of reagent/sample probe
When the device is running, do not put your hand or any other part of your body or
place any obstacle on the movement track of the reagent/sample probe; otherwise
personal injury or damage to the device may be caused.
Cleaning of reagent/sample probe
A convectional oblique-spray cleaning cell is used for cleaning of the
reagent/sample probe; system water is used to clean the inner and outer walls of
the probe. Enhanced Washing Buffer on the device is used for intensified cleaning
of the reagent/sample probe.
Special reagent cartridge
The special reagent cartridge is arranged vertically on the left side of the
pretreatment unit, and is used to carry multi-component kits.
The special reagent cartridge has 10 reagent positions in total; it supports RFID
scanning and magnetic bead blending.
The special reagent cartridge supports 24h uninterrupted refrigeration at 4℃-15℃,
which ensures that the reagent contained in each reagent bottle is always stored in
a low-temperature environment, thus to guarantee stable performance of the
reagent.
When adding a special reagent, tear off the film and check for air bubbles which can
affect the accuracy of test results.
Multi-component kits
Multi-component kits are used to place special test reagents. Four components are
combined in each set of kits, and only one kit can be placed at each reagent
position.
26
Fig. 1-5 Multi-component kits
Magnetic bead blending

Reagent in a reagent bottle is blended by non-contact rack and pinion through
agitation by the two fins in the magnetic bead bottle.
Sample cartridge
The sample cartridge is used to place sample racks containing samples to be tested;
it supports at most three rows of 10-position sample rack.
Sample rack
Fig. 1-6 Sample rack
The sample rack contains 10 sample positions, each carrying a position

identification barcode. It supports sample vessels with the following specifications:
Micro cups
 Φ12x37mm 2mL Hitachi standard cups
 Φ12.3x42mm 1.8mL calibrator/QC vials(Use the sample rack adapter)
Primary blood collection tubes
 Φ12x68.5mm
 Φ12x99mm
 Φ12.7x75mm
 Φ12.7 x100mm
 Φ13x75mm
 Φ13x95mm
27
 Φ13x100mm
The minimum sample volume varies with respect of the specification of sample tube.
The minimum sample volume must be guaranteed for each sample tube, otherwise
sample aspiration error may be caused. If the sample volume is less than the dead
volume, please transfer the sample to a smaller sample tube prior to test.
Dead volumes of different sample tubes are listed in the table below:
Table 1-10
Sample vessels Dead volume
Φ12 x 37mm 2mL Hitachi standard cups 200 µL
Φ12.3 x 42mm 1.8mL calibrator/QC vials 200 µL
Φ12 x 68.5mm
Φ12 x 99mm
600 µL
Φ12.7 x 75mm
Φ12.7 x 100mm
Φ13 x 75mm
Φ13 x 95mm 1000 µL
Φ13 x 100mm
1.3.2. Incubation Unit

The incubation unit mainly consists of a reaction tray and assay cups. The reaction
tray is designed with a disc structure positioned in the middle of the device.
Reaction tray
The reaction tray is divided into zones A, B, C and D; a set of 25 assay cups can be
placed in each zone (100 assay cups in total).
With the temperature control function, the reaction tray can provide a
constant-temperature environment at 37±0.5℃.
Fig. 1-7 Reaction tray

Disposable plastic assay cups are used for containing reaction liquids and for
incubation. The assay cup set can be replaced manually after 25 tests are finished.
Assay cup set
A assay cup set consists of 25 assay cups which are disposable consumables and
28
cannot be separately used. It is used to contain and incubate reaction liquids. The
assay cups are loaded or replaced by set, and it is not allowed to replace a single
assay cup; the maximum volume of each assay cup is 250uL.
Fig. 1-8 Assay cups
1.3.3. Analytical Unit

The analytical unit is on the right side of the device. It mainly consists of a 2D robotic
arm, a system reagent cartridge and a cleaning cell. The 2D robotic arm carries the
aspiration probe to aspirate reaction liquid and system reagent from the assay cups
and the system reagent cartridge. Through time sequence control, the liquids enter
the measuring chamber from the liquid line, and then are discharged into the waste
liquid tank after measurement; every time before aspirating a different liquid, the
aspiration probe will enter the cleaning cell to clean any residual liquid on the outer
wall.
Fig. 1-9 Structure of analytical unit

Aspiration probe
The aspiration probe is used to aspirate reaction liquids and system
reagents.
Fig. 1-10 Structure of aspiration probe
When the device is running, do not change the system reagent, or put your hand or
any other part of your body or place any obstacle on the movement track of the
29
aspiration probe; otherwise personal injury or damage to the device may be caused.
Cleaning of aspiration probe
A fountain-type cleaning cell is used for cleaning of the aspiration probe; system
water is used to clean the outer wall of the probe.
System reagent cartridge
The system reagent cartridge is designed with a horizontally arranged structure; it is
positioned on the right side of the pretreatment unit, and is used to carry system
reagents (Buffer solution and Auffer cleaning solution).
The system reagent cartridge provides the temperature control function, which
ensures that the reagent contained in each reagent bottle is always stored in a
constant-temperature environment at 28±2℃, thus to guarantee stable performance
of the reagent.
1.3.4. Liquid Line Unit

The liquid line unit is on the right side of the device; it is mainly used for time
sequence control of liquid line, probe cleaning and waste liquid discharge.
Plunger pumps
The reagent/sample plunger pump is on the right side of the device. You can see
two syringes after opening the right-side door. The left is the reagent/sample plunger
pump, and the right is the aspiration plunger pump.
Fig. 1-11 Plunger pumps
1.3.5. Connection of System Water and Waste Liquid Lines

The connectors for system water and waste liquid lines are positioned on the rear
right side of the device. System water is used to flush the inner and outer walls of
probes and eliminate air in the liquid line, thus to ensure sampling accuracy. The
waste liquid line is mainly used to transfer waste liquid discharged by the device to
the waste liquid bucket.
30
Fig. 1-12 Liquid line connection
1.3.6. Circuit Connection

Circuit ports are positioned on the rear left side of the device; the LIS can be
connected via RS232 serial port and RJ45 network port; USB flash drive and other
standard USB peripherals can be connected via USB port.
Fig. 1-13 Circuit connection
1.3.7. Barcode Scanner

The barcode scanner is positioned on the left side of the sample cartridge inlet,
which will be started up automatically when the door of the sample cartridge is open.
Barcode types supported by the barcode scanner are listed in Table 1-11.
Table 1-11 Barcode types
Code type Data length Width Height
Codebar 1-25 0.3-0.8 10mm
Code2/5 Interleaved 2-24 0.3-0.8 10mm
Code39 1-25 0.3-0.8 10mm
31
Code93 1-25 0.3-0.8 10mm

Code128/EAN128 1-25 0.3-0.8 10mm
Code UPCA/UPCE 8 0.3-0.8 10mm
Code EAN 8/13 8/13 0.3-0.8 10mm
Note: A barcode scanner is integrated in eCL 8000 and eCL 8000i, but not in eCL
8000p and eCL 8000x.
1.3.8. Display
The device is equipped with a color touch screen; the bundled software can be used
to operate the device via both the external mouse and the touch screen.
1.3.9. System software

System software: Windows 7 Operating System in Chinese
Device software: User operating software for eCL 8000 Fully Automated ECL
Analyzer
Software version: 00.00.03
32
Chapter 2 Operating Principle
 2.1 Measurement Principles

 2.2 Test Methods
 2.3 Calibration Methods
33
2.1. Measurement Principles

Depending on the immunoreaction mode, the device mainly applies two
measurement principles: sandwich assay and competitive assay. Sandwich assay is
used to determine macromolecular antigens and antibodies such as TSH and HCG;
competitive assay is mainly used to determine micromolecular antigens such as T4.
2.1.1. Sandwich Assay

Step 1: Let macromolecular antigen (Ag) in the sample to be determined,
biotin-labeled antibody (Btd-Ab) and luminescent-marker-labeled antibody (Ru-Ab)
react in one assay cup. After incubation for a while, sandwich immune complexes of
(Btd-Ab)-Ag-(Ru-Ab) will be formed;
Step 2: Add streptavidin-coated magnetic beads (M); after incubation for a period,
magnetic bead immune complexes of M-(Btd-Ab)-Ag-(Ru-Ab) will be formed;
Step 3: Transfer the reaction
product of Step 2 to the measuring
cell; magnetic bead immune
complexes will be adsorbed onto
the working electrode by the
magnet; meanwhile, rinse the
electrode with TPA buffer solution
to remove unbound sample and
reagent;
Step 4: Remove the magnet,
apply voltage to the electrode to
start ECL reaction and record
electrochemical signals (see Fig.
2-1).
As can be seen, when the double
antibody sandwich method is used
in the reaction system of the
device, luminescence intensity
increases as more Ag in the
sample is bound to Ru-Ab.
Therefore, the ECL intensity is
directly proportional to the
concentration of antigen in the
sample to be tested.
34
2.1.2. Competitive Assay

Competitive assay is mainly used to determine micromolecular antigens following
the steps below.
Step 1: Let macromolecular antigen (Ag) in the sample to be determined and
luminescent-marker-labeled antibody (Ru-Ab) react in one assay cup and incubate
for a period;
Step 2: Add biotin-labeled antigen (Btd-Ag) and streptavidin-coated magnetic beads
(M); now antigen (Ag) in the sample and Btd-Ag will be competitively bound to
Ru-Ab. As a result of the specific affinity interaction between biotin and streptavidin,
biotin will be specifically
bound to streptavidin,
forming magnetic bead
immune complexes of
M-(Btd-Ag)-(Ru-Ab);
incubate for a while;
Step 3: Transfer the
reaction product of Step 2
to the measuring cell;
magnetic bead immune
complexes will be
adsorbed onto the working
electrode by the magnet;
meanwhile, rinse the
electrode with TPA buffer
solution to remove
unbound sample and
reagent;
Step 4: Remove the
magnet; apply voltage to
the electrode to start ECL
reaction; record
electrochemical signals
(see Fig. 2-2).
As can be seen, when
competitive assay is used
in the ECLIA reaction
system, Ag in the sample
to be determined and
Btd-Ag are competitively bound to Ru-Ab, whereas only Btd-Ag can be bound to M
and therefore attracted and fixed by the magnet, forming the complexes of
M-(Btd-Ag)-(Ru-Ab). Then the complexes are involved in TPA excited ECL reaction;
higher luminescence intensity indicates that Btd-Ag is competitively bound to more
antibodies and that Ag in the sample to be determined is bound to fewer antibodies.
Therefore, the ECL intensity is inversely proportional to the concentration of antigen
in the sample to be determined.
35
2.2. Test Methods

In chemiluminescence immunoassay, after the antibodies and the analyte form
immune complexes on the surface of magnetic beads, the complexes are carried by
buffer solution into the measuring cell.
Immune complexes formed on the surface of magnetic beads will be adsorbed by
the magnet below the measuring cell to the electrode surface; immune complexes
failing to bind magnetic beads cannot be adsorbed to the electrode surface, and are
directly flushed away from the electrical excitation zone by buffer solution.
Upon applying excitation voltage, tris (2,2’-bipyridine) ruthenium(II) in excited state
will emitted photons at 620 nm wavelength.
The intensity of optical signals detected by the photomultiplier tube above the
measuring cell is correlated with the amount of analyte captured on the surface of
magnetic beads, thus quantitative analysis of the analyte can be realized.
After the test, flow cleaning solution into the measuring cell to clean the pipeline and
prepare for the next test.
Photomultiplier tube
Electrode
Magnet
Flow path
Fig. 2-3 Schematic diagram of ECL test method
36
2.3. Calibration Methods

2.3.1. Overview
Two calibration methods are mainly applied in the device: quantitative and
qualitative methods. For quantitative calibration, two-point calibration method is
used to correct the master calibration curve matching the reagent kit and obtain the
working curve. Then the signal value in sample test is converted to a concentration
value through calculation.
2.3.2. Quantitative Analysis

Before delivery of reagents, master calibration curves corresponding to reagents for
different items and of different lot numbers will be generated.
Each master calibration curve is fitted using four parameters; the calibration
equation is given below.
ad
y d
x
1  ( )b
c
where, y is the concentration; x is the signal value of sample; a, b, c and d are
respectively the parameters related to the specific item.
Through calculation by nonlinear regression, the concentration of multi-point
calibrator and the signal values measured on several devices are fitted to obtain
parameters a, b, c and d of the four-parameter calibration equation, thus to generate
the master calibration curve matching the reagent kit.
Users can perform two-point calibration to reagents, and adjust the four-parameter
master calibration curve matching the reagent kit based on the data processing
algorithm for the respective reagent item; the calibrated working curve obtained can
be used when calculating the result of clinical samples. The calculation equation is
given below.
ad
x d
y
1  ( )c
b
2.3.3. Qualitative Analysis

Depending on the reagent item, test the signal value of single-point or two-point of
calibrators and calculate the cutoff value; judge the nature of the sample by
comparing the signal value in sample test and the cutoff value. The equation for
calculation of the cutoff value is given below.
Cutoff  a  x1  b  x2  c
where, x1 and x2 are respectively the two-point signal values of calibrators; a, b and
c are respectively parameters related to the specific item.
37
eCL 8000 User Manual Chapter 3 Installation Requirements and Steps
Chapter 3 Installation Requirements

and Steps
 3.1 Installation Requirements

 3.2 Installation Steps
38
3.1. Installation Requirements

3.1.1. Power Requirements
 Voltage: AC (100-240) V;
 Frequency: 50/60Hz;
 Rated input power: 800VA.
Please ensure that the power outlet is properly grounded, otherwise electric shock
or damage to the device may be caused. Please confirm that grounding condition in
the place where the device is used meets the requirement, and that proper circuit
breaker or fuse has been installed.
3.1.2. Environmental Requirements

 Normal operating temperature: 10℃~30℃;
 Normal operating humidity: <80% at 30℃, non-condensing;
 Atmospheric pressure: 75 kPa~106 kPa;
 Environment that free from dust, mechanical vibration, sources of big noise
and power interference as far as possible;
 Before running the device, it is suggested to evaluate the electromagnetic
environment in the laboratory;
 In order not to affect normal operation of the device, please avoid placing the
device close to sources of strong electromagnetic interference;
 Avoid placing the device near brush motors, flashing fluorescent lights and
electrical contact equipment that is frequently turned on and off;
 Keep the device away from direct sunshine or sources of heat and wind;
 Do not place the device at a position where it is difficult to turn off the switch;
 Put the device in a well-ventilated place, and do not use it in an inflammable or
explosive environment;
 The device can be used only when proper grounding is ensured.
 The surface of fitter’s bench is smooth, The tilt is less 1/200; Fitter’s bench can
bear more weight which the number of device multiple 100KG;
3.1.3. Space Requirements

Please install the device according to the following diagram.
39
Wall
Fig. 3-1 Space requirement for installation of the device
3.1.4. Liquid Discharge Requirements

 When the waste liquid bucket is used for discharge of waste liquid, it must be
emptied before and after every test to prevent overflow of waste liquid;
 When the waste liquid bucket is used for discharge of waste liquid, the pipe
connecting the device to the waste liquid bucket should not be longer than
2m;The distance between the waste liquid bucket mouth and bottom of device
is less 200mm;
 When replacing the waste liquid bucket, take care to avoid spill of waste liquid;
 When the discharge channel is used for discharge of waste liquid, the
diameter of discharge outlet should not be less than 30mm, and the discharge
outlet should be at most 200mm above the bottom of the device;
Please dispose of wastes in accordance with applicable local regulations on

disposal of wastes posing biohazards;
When connecting the waste liquid pipeline, please wear gloves, work clothes and
other PPE to prevent infection.
When connecting the device pipeline, take care not to bend or squeeze the water
pipeline.
3.2. Installation Steps

3.2.1. Unpacking
The device has been inspected strictly prior to delivery, and has been carefully
designed and packaged in order to avoid collision during transportation. Upon
arrival of the device, please carefully check its package to see if there is any
physical damage; if any, please inform Lifotronic’s Customer Service Department or
the local agent immediately. After confirming that no external damage exists, unpack
the device according to the following steps:
 Place the packaging box upright, and make sure the arrow on the packaging
40
box faces upward;

 Use a tool to open the sealing tape on the packaging box; take out the
Packing List to check the completeness of articles. In case of any shortage,
please inform Lifotronic’s Customer Service Department or the local agent
immediately;
 Remove the upper foam cover for fixing; take the device out of the packaging
box, and place it on a tabletop.
3.2.2. Carrying Method

 Prior to carrying and transportation, remove all reagent kits in the device to
avoid drop during carrying;
 Under smooth road conditions, it is allowed to use trolleys and other
transportation means for short-distance transportation;
 If the analyzer has been used, confirm that the liquid line is emptied prior to
carrying;
 During carrying and transportation, take care to protect the display screen and
the pipetting probe from external force and ensure that they will not come into
contact with other objects to avoid damage;
 During carrying and transportation, keep the device upright and avoid vibration
whenever possible; do not tilt the device or place it sidewise. After carrying,
check and commission the device before use;
The device must be placed on a solid horizontal surface instead of an inclined

surface.
Properly keep the packaging box so that it can be used to package the device for
long-distance transportation in the future.
41
eCL 8000U User Manual Chapter 4 Operating Instructions
Chapter 4 Operating Instructions
 4.1 Overview
 4.2 Check before Startup
 4.3 Switch-on
 4.4 Preparation before Operation
 4.5 Calibration Operation
 4.6 QC Operation
 4.7 Normal Sample Test
 4.8 Daily Maintenance
 4.9 Shutdown
42
4.1. Overview
This chapter describes the process for operation of the device.
4.1.1. Operation Flow
Fig. 4-1 Operation process
4.2. Check before Startup

4.2.1. Device Connection Check
 Check the power supply to confirm that voltage required by the device can be
supplied;
 Check the LIS data cable to determine that the LIS server is reliably
connected to the device.
4.2.2. Printing Paper Check

 Check whether printing paper in the printer is sufficient; if not, please replenish
printing paper;
 Pull open the printer lever outward to open the printer door. Load printing
paper into the paper cavity in the direction shown in Fig. 4-1, with the paper
end positioned outside the paper outlet. Close the printer door; check the
position of recording paper to ensure that the recording paper is flush with the
paper outlet.
43
Fig. 4-2 Loading printing paper
4.2.3. Consumables Check

 Check the system water container to see if it is sufficient;
 Check the waste liquid container to see if it is emptied;
 Check that the appearance of reagent/sample probe and aspiration probe is in
good condition, without dirt or bending;
 Check that the system water and waste liquid pipelines are not squeezed or
bent.
When checking the waste liquid container, please wear gloves, work clothes and
other PPE to prevent infection.
44
4.3. Switch-on
4.3.1. Startup
There are two power switches on the device:
 “Main Unit” switch: Controls power-on/off of the main unit;
 “Refrigeration” switch: Controls power-on/off of the special reagent cartridge.
Ensure that the device is correctly connected to a power outlet, and turn on the
“Refrigeration” and “Main Unit” power switches in sequence.
Fig. 4-3 Power switches of the device
Do not turn on and turn off switch of device at short notice so as not to damage the
device
Turn off the power immediately ，disconnect the power connection line and inform
Lifotronic’s Customer Service Department or the local agent immediately in case of
device emit smell, smoke, spark, liquid leakage, etc.
4.3.2. System Initialization

After the “Main Unit” switch of the device is turned on, the control software will
automatically start operation. During system initiation, the “Login” interface is
displayed, and each unit is reset to the original position.
45
Fig. 4-4 Software login interface
1. Enter the user name and the password in the [Login] dialog box, and click [Login];
2. When the initialization is finished, confirm that the status bar on the screen displays
the “Standby” state.
To ensure the accuracy of test results, please perform tests 30min after startup of
the device when the temperature of each temperature control unit of the device
becomes stable.
4.4. Preparation before Operation

4.4.1. Confirmation of Device States
In order to ensure smooth operation upon startup of the device, it is necessary to
confirm various states of the device, including the states of system reagent,
immunological reagent, consumables, fault alarm, maintenance alarm, etc.
When the malfunctions, maintain and troubleshoot it referring to Chapter 6
Maintenance and Chapter 7 Alarms and Troubleshooting.
1. Confirm the system reagent state
Before starting test every day, it is necessary to check the remaining volume of
Buffer solution, Auffer cleaning solution, system water and Enhanced washing buffer,
and also to confirm whether the waste liquid is full. In case of any abnormality alarm,
handle it in a timely manner.
46
Table 4-1 Illustration of system reagent state

System
Function Illustration Meaning Measure
reagent
Not loaded or Loading or changing with

used up new Buffer solution
Buffer solution
used to transfer
Buffer
test liquid to the
measuring cell
Normal None
Cleaning Not loaded or Loading or changing with

solution used to used up new Auffer solution
clean the
Auffer
aspiration probe,
analytical liquid
line and
Normal None
measuring cell
Enhanced
Washing Buffer Loading or changing with
Not loaded or
Clean used to clean the new Enhanced Washing
used up
reagent/sample Buffer
probe
Cleaning the Normal None

System
reagent/sample
water
probe Used up Replenishing system water
Not full None

Waste liquid
Waste liquid
after test
Discharging the waste
Full
liquid
2. Consumable state
47
Before requesting a sample test every day, it is necessary to check the remaining
number of assay cups; if inadequate, change or add assay cups in a timely manner.
As to how to change assay cups, refer to 4.4.2 Loading Reagents and
Consumables.
Table 4-2 Illustration of assay cup state
Reagent name Illustration Meaning Solution
Changing assay
Empty
cups
Full None
Neither empty nor

None
full
3. Immunological reagent state
1) Click the [System] menu button to enter the system interface, and view the
[Immunological Reagent] state on the left side of the interface;
2) View the immunological reagent state and color mark, as shown in the table
below;
Table 4-3 Illustration of immunological reagent state

Color State Meaning
Usable The current reagent kit is usable
The current reagent kit is faulty, which may be

caused by no calibration, calibration failure,
WARNING
reagent expiration, calibration expiration, login
time not reached, servings used up
In position Reagent is in position, but not loaded
Empty
There is no reagent kit in the current position
position
3) In case of reagent abnormality, click the [Reagent] menu button to enter the
Reagent interface, and view details of abnormal immunological reagent state.
4. Fault alarm state
48
1) Check the button in the upper part of the main interface; if the button is
displayed in red and fault information is displayed in a scrolling manner
in the fault prompt zone at the top of the window, it indicates the system is
faulty;
2) Click the button to enter the [Current Faults] interface, and view the
list of faults reported by the system upon startup.
Fig. 4-5 Alarm center
 Select any entry under [Current Faults]; click [Fault Details] to view detailed
information of and solution for this fault;
 Fix the fault according to the recommended solution; if the problem still exists,
please contact our maintenance personnel.
4.4.2. Loading Reagents and Consumables

1. Loading and changing assay cups
The device uses disposable assay cups to complete the immunoreaction incubation
process. A assay cup set is made up of 25 assay cups; totally four sets (100 assay
cups) can be placed simultaneously. Prior to test, if the [System] interface shows
that the remaining number of assay cups is inadequate or assay cups are not
loaded, please load or change assay cups according to the following steps.
1) After opening the front cover of the device, you can see the assay cup loading
zone;
2) In the assay cup Changing interface, select the zone where assay cups are to
be changed or loaded;
3) The corresponding zone of the reaction tray will move to the loading zone;
49
4) Remove the used assay cups; in case of absence of assay cups, skip this
step;
5) Place a new assay cup set in the loading zone, and click [Save];
6) To further change or load assay cups in other zones, please repeat steps 2~5.
Fig. 4-6 Assay cup Changing interface
Fig. 4-7 Loading Assay cups
2. Loading immunological reagent
Before loading any immunological reagent, it is necessary to read reagent info by

approaching the labeled side of the immunological reagent kit to the reagent
50
scanning area; put the kit in the reagent cartridge after the Reagent Info interface
pops up.
Reagent can be loaded only when the system state is “Standby”.
Fig. 4-8 Reading reagent info
Fig. 4-9 Puting the reagent kit in the reagent cartridge
51
3. Loading system reagent
Take out the system regent from regent packing, open the cap of bottle, and then
change the cap with mached silicone cover. Put the Auffer and Auffer by Fig.
4-10, when the state of system is “standby”, it can be permit to be loaded and change
system reagent.
Fig. 4-10 Buffer/Auffer
4.5. Calibration Operation

Calibration test can be requested only when the reagent to be calibrated has been
loaded and the number of test servings is sufficient.
4.5.1. Calibration Operation Flow
Fig. 4-11 Calibration operation process
4.5.2. Preparation for Calibration Test

Prepare the calibrator and the immunological reagent to be calibrated.
52
4.5.3. Calibration Operation

1) Calibrator pretreatment;
Liquid calibrator: Place the calibrator on a whirlpool mixer and mix for 10 to 20
seconds (remove the bubbles with a pipette gun if bubbles occur after mixing), and
then put them in the sample frame for 10 to 15 minutes.
Freeze-dried calibrator: According to the operation instructions of calibrator in

various reagent product specifications, the freeze-dried products were
re-dissolved. After dissolved the calibrator, put it in the sample frame for 10~15
minutes. If long-term storage is needed, it is recommended that the calibrator
should be packed separately and stored at -20 degree. To use the dissolved and
frozen calibrator, it is necessary to set them at room temperature for 10-15
minutes to melt and return to normal temperature, then mix them with a whirlpool
mixer for 10-20 seconds (if bubbles occur after mixing, remove bubbles with a
pipette gun), and put them in a sample frame for 5 minutes.
2) In the [Reagents] interface, select the immunological reagent to be calibrated,

and click [Calibration Request];
3) Select the low-value calibrator position and the high-value calibrator position
by pressing the [Select] buttons.
Fig. 4-12 Calibration request
4) Click [Save] in the interface;
5) Click to start the calibration test.
53
1.To ensure an accurate result, please start the test after the immunological reagent
is loaded 30min.
2.Put high value calibrator prior to low value calibrator.
3. When using the calibrator/QC vials for calibration, it is necessary to install the
vials into the sample rack adapter first, and make sure that the vials are pushed to
the bottom of the adapter, and then installed into the sample holder for use.
4.5.4. Calibration Result

When the calibration test is finished, enter the [Results] interface, and select
[Calibration Result] to view the calibration result.
Fig. 4-13 Viewing calibration result
4.5.5. Execute Calibration

1. In the [Reagents] interface, select the immunological reagent having been
performed the calibration test, and click [Execute Calibration];
54
Fig. 4-14 Executing calibration
2. Click [Calibrate] to execute calibration.

In case of unsuccessful calibration, you can change the L and H values and click
[Calibrate] again, or request a calibration test again.
4.6. QC Operation
QC is an important means for testing whether the device can run normally. In order
to ensure stable test performance of the device, QC test is suggested to be
performed every day.
4.6.1. QC Operation Flow
Fig. 4-15 QC operation process

4.6.2. Preparation for QC Test
Prepare the QC material and the immunological reagent for QC test
4.6.3. QC Operation
1) QC material pretreatment ;
Liquid QC material: Place the QC material on a whirlpool mixer and mix for 10 to
20 seconds (remove the bubbles with a pipette gun if bubbles occur after mixing),
and then put them in the sample frame for 10 to 15 minutes.
55
Freeze-dried QC material: According to the operation instructions of QC material

in various reagent product specifications, the freeze-dried products were
re-dissolved. After dissolved the QC material, put it in the sample frame for 10~15
minutes. If long-term storage is needed, it is recommended that the QC material
should be packed separately and stored at -20 degree. To use the dissolved and
frozen QC material, it is necessary to set them at room temperature for 10-15
minutes to melt and return to normal temperature, then mix them with a whirlpool
mixer for 10-20 seconds (if bubbles occur after mixing, remove bubbles with a
pipette gun), and put them in a sample frame for 5 minutes.
2) Select the sample rack where the QC material is placed ,Click the [Request]
menu button;
3) Select the high and low sample position where the QC material is placed;
4) Click [Sample Request] to select the immunological item requiring QC test; set
the sample attribute to “QC”;
5) Select the QC material usable for this QC item;
6) Set the test level (L or H) of current QC material, Click [OK];
7) Click to start the QC test.
1.To ensure an accurate result, please start the test after the immunological reagent
is loaded 30min.
2. When using the calibrator/QC vials for QC test, it is necessary to install the vials
into the sample rack adapter first, and make sure that the vials are pushed to the
bottom of the adapter, and then installed into the sample holder for use.
Fig. 4-16 QC request
56
4.6.4. QC Result
When the QC test is finished, enter the [Results] interface, and select [QC Results]
to view the QC result.
Fig. 4-17 View QC result
4.6.5. QC Statistics
1. QC Setup
Select [QC] and enter [QC Setup] to view the QC material state.
57
Fig. 4-18 QC setup
2. QC Statistics
Set the item name, QC level, QC month and lot number of QC material, and the
system will automatically plot the QC graph under the current conditions and obtain
the QC conclusion.
58
Fig. 4-19 QC statistics
4.7. Normal Sample Test

Prior to normal sample test, please check the system state and confirm the usability
of all reagents and consumables.
4.7.1. Operation Flow of Normal Sample Test
Fig. 4-20 Operation process of normal sample test

4.7.2. Preparation for Sample Test
Prepare the sample to be tested and the immunological reagent.
4.7.3. Normal Sample Test
Sample request
1. General request
There are three modes of sample request: Normal Mode, Barcode Mode and Online
Mode. Under different conditions, you can select the corresponding mode to request
a sample ID.
All models support manual input of sample ID. eCL 8000 and eCL 8000i support
automatic recognition of sample barcodes with the scanner integrated in the device;
eCL 8000 and eCL 8000p support manual recognition of sample barcodes with an
external barcode scanner.
1) Click [Request] to select the sample rack to be edited, and select the sample
request mode:
 Normal Mode
Enter the sample ID which can consist of digits or a combination of letters and digits;
 Barcode Mode
When the sample rack is inserted, the device will automatically read the sample ID;
 Online Mode
Acquiring edited sample info issued by the LIS; in such case, steps 2) ~7) can be
ignored.
2) Select the sample attribute: Normal or Emergency;
3) Set whether the sample is pre-diluted or not and set the pre-dilution ratio;
4) Select the sample type: Serum, Plasma, Urine, Amniotic Fluid, Other;
5) In the item list, select the test item, set the times of test (default: 1; input range:
1-100); and set whether the sample is diluted or not and set the dilution ratio;
6) Click [OK] to go back to the [Request] interface;
7) Select a sample, and click [Patient Info] to add patient info for the selected
59
sample;
8) Click to start the sample test.

Before requesting a normal sample test, confirm that the immunological reagent for
the sample test item has been calibrated and the calibration is not expired;
otherwise the system will not give the test result.
2. Additional Request
If an additional test is required, repeat all steps in “General request”.
The additional request can be made only by adding a sample rack.
4.7.4. Sample Result

When the sample test is finished, enter the [Result] interface, and select [Normal
Result] to view the sample test result.
Fig. 4-21 Sample result
1. Edit Patient Info
During sample request and test, you can input patient info in the [Request] interface.
After the sample test, patient info can be viewed and modified only in the [Normal
Results] interface:
1) Enter [Result] - [Normal Result]; select [Patient Info], and query and select the
sample requiring edition of patient info;
2) Input relevant patient info;
3) Click [Save] to save the patient info and return.
2. Sample Review
60
Select a sample having been tested, and click [Sample review].

3. Printing or Transferring
Select a sample having been tested, and click [Print] or [Transfer].
4.8. Daily Maintenance

After all tests are finished every day, daily maintenance of the device should be
performed according to the requirements on daily maintenance.
Daily maintenance items include:
 Cleaning the reagent/sample probe;
 Cleaning the aspiration probe;
 Cleaning the measuring channel.
For details of maintenance operation, please refer to Chapter 6 Maintenance.
4.9. Shutdown
4.9.1. Shutdown
1. Confirm that the system is in “Standby” state;
2. Click at the upper left corner of the main interface, and select [Shut Down
System];
3. When the display screen is turned off, first turn off the “Main Unit” power switch; then
turn off the “Refrigeration” power switch.
When both power switch are turned off, the refrigeration system of the special
reagent cartridge will stop running. Please timely take the reagents out of the
reagent cartridge and put it in a refrigerator.
If continuous running of the refrigeration system of the special reagent cartridge is
required, do not turn off the “Refrigeration” power switch.
4.9.2. Operation after Shutdown

1. Take out the calibrators, QC material and samples;
2. Check the panel. Any stains should be wiped off with a clean, soft cloth;
3. Check and empty the waste liquid bucket;
4. Check the reaction tray. Empty used assay cups.
61
eCL 8000 User Manual Chapter 5 Data Transmission Function
Chapter 5 Data Transmission
 5.1 Overview
 5.2 ASTM instruction
 5.3 ASTM Communication
 5.4 ASTM Communication option
62
5.1. Overview
This chapter introduces the connection of user’s LIS with the device and use of the
LIS.
5.2. Connection with LIS

ASTM port is new developed function which Fully Automated ECL Analyzer adapt to
booming LIS, it use connection of TCP/IP or serial port, Server of LIS can receive data of
test from local device and send information of sample request to Fully Automated ECL
Analyzer. The transmission format of this interface data is created according to the ASTM
version of E1397-97.This interface supports two-way transmission of device and LIS
systems.
5.2.1 Lifotronic’s ASTM protocol
As the port of Lifotronic’s ASTM use a part of data, some type of message, record and
other data of ASTM .
5.2.2 The Transceiver process in the protocol
The operation model of SATM protocol link is simplex model, the transmission of data at
a time point can only be in one direction, that is to say, when the device is sending the data,
the computer can only wait for receiving data and when the computer send the data, the
device can only receiving data.
The ASTM protocol specifies that when the sender needs to send data it firstly send ENQ
command of control to intentional receiver, if the receiver have resource it will answer ACK
command for sender, otherwise it will answer NAK command, sender will send data frame
after it receive the ACK command.it will send EOT command after send all data frame, it
means that the process of transmission is over.
table 5-1 control command list
command ASCII code HEX
<ENQ> 0x05
<ACK> 0x06
<EOT> 0x04
<NAK> 0x15
<STX> 0x02
<LF> 0x0A
<CR> 0x13
<ETB> 0x17
<ETX> 0x03
5.3. ASTM Communication

5.3.1 ASTM protocol format
The chapter describe the use of Lifotronic’s ASTM interface, the below describe general
rule of syntax. ASTM define 7 record of message respectively.
1. Message Header Record
63
2. Patient Information Record

3. Test Order Record
4. Result Recorcd
5. Comment Record
6. Request Information Record
7. Message Terminator Record
eCL8000 implement all the records, the sending data include some or all above
record ,such as a entire data frame of ASTM protocol for test result of sample
is as below:
Message Header Record
Patient Information Record
Test Order Record
Result Recorcd
Comment Record (optional)
Result Recorcd
Patient Information Record
Test Order Record
Result Recorcd
...
Message Terminator Record
Each ASTM message consist of some message record, and it end by CR command.
Each record consists of a record name of character, some number of field, the
field include some component, each H record of message define separators of
each component, such as
H|\^&|||ECL8000^01.03.00^123456|||||||PR|1394-97|20160910102501<CR>
Thereinto, The four character behind H distinguish from each field, repeat,
separator of component, Lifotronic’s ASTM interface use below character of
table.
table 5-1 character list
character Significance
| separator of field
\ separator of repeat
^ separator of component
& Escape character
5.3.2 ASTM data format of record
All sending ASTM format of record is as below:
<STX> FN <FRAME> <CR> <ETB> or <ETX> <CS><CR><LF>
Thereinto,
<STX> beginning data frame
64
FN: number of data frame(0~7)

<FRAME> ：data frame (separator of field|)
<CR> ：Ending character of data frame (0x0D)
<ETB> ：ending character of frame–when the request data are too long, it need
send by multiply frame, it means ending character of multiply sending frame
(0x17);
<ETX> ：ending character of frame(0x03)
<CS> ：check sum –code accumulating sum from FN to ETB or ASCII of ETX, not
calculate the sum of STX and CS and detail of CR and LF
<CR> ：ASCII enter character（0x0D）
<LF> ：ASCII linefeed（0x0A）
ASTM protocol divide into middle frame and ending frame, middle frame is not
necessary, if the message is too big data, middle frame support sending frame
data. Ending frame is necessary frame, ending frame means end of all data frame.
The format of middle frame：<STX> FN <FRAME> <ETB> <CS> <CR><LF>
The format of ending frame：<STX> FN <FRAME> <ETX><CS> <CR><LF>
Thereinto, CS is check sum of one frame, firstly calculate accumulate sum of FN
to ETB or ASCII of ETX, then accumulation sum reminder to 256,high byte put first
byte of CS, low byte put the second byte of CS.
5.3.3 ASTM code message record
Recode type Description of record
H Header Record
P Patient Record
O Order Record
R Result Record
C Comment Record
Q Request Information Record (Host query)
L Terminator Record
5.4. ASTM communication option

Application->system setting->LIS network setting, the link of Lifotronic’s LIS contains
following three kinds:
1. TCP/IP client
Device is as client, it link to designated server
2. Serial port
Serial data link it directly
65
table 5-2 serial port
option specifications
Com port
Baud rate 4800,9600,19200,34800,57600,115200
Data byte 8
Check byte None
End byte 1
66
eCL 8000 User Manual Chapter 6 Maintenance
Chapter 6 Maintenance
 6.1 Overview
 6.2 Maintenance Items
 6.3 Scheduled Maintenance
 6.4 On-demand Maintenance
 6.5 Unscheduled Maintenance
 6.6 Maintenance Record Forms
67
6.1. Overview
The content of this section involves maintenance of the device. In order to keep a
stable and good operating state of the device, please maintain the device as
scheduled or on demand according to requirements specified in this chapter.
Description of maintenance items consists of the following parts:
 Precautions
 Materials needed
 Operation process
 Do not perform maintenance operations not clearly specified in this chapter,

otherwise damage to the device or personal injury may be caused;
 During maintenance, do not splash any liquid onto any mechanical or
electrical part of the device;
 The fuses (F5L250V) of the device are replaceable; please use fuses
provided by Lifotronic for replacement.
When maintaining the device, please wear gloves, work clothes and other PPE to
prevent infection.
Table 6-1 List of accessories

Part Specification QTY Unit Period of replacement
Reagent/sample Non-scheduled; replacing
/ 1 PCS
probe when it is damaged.
Non-scheduled; replacing
Aspiration probe / 1 PCS
when it is damaged.
Replacing when it has
ID1.0mm-OD3.0
Pinch valve hose 2 PCS been used for 3 months or
mm x150mm
is obviously damaged.
Replacing on an annual
Measuring cell / 1 PCS
basis or after 20,000 tests
System water Non-scheduled; replacing
10L 1 PCS
bucket when it is damaged.
Waste liquid Non-scheduled; replacing
10L 1 PCS
bucket when it is damaged.
Non-scheduled;
Printing paper Φ50x57mm 1 Roll replenishing after it is used
up
6.2. Maintenance Items

This section lists all maintenances items and describes them briefly.
6.2.1. System Initialization

Restart the mechanical parts of this device so that they can return to their initial
positions. If the device stops due to any fault, the “System Initialization” operation
68
must be performed to reset the system position.
6.2.2. Clean the Liquid Channel

Thoroughly clean the liquid line of aspiration probe with system cleaning solution.
6.2.3. Filling the Liquid Line of Reagent/Sample Probe

Fill the liquid line of reagent/sample probe with system water according to the
frequency set in the system, thus to eliminate air in the pipeline.
6.2.4. Filling the Liquid Line of Aspiration probe

Fill the liquid line of aspiration probe with system water according to the frequency
set in the system, thus to eliminate air in the pipeline.
6.2.5. Preparing the Measuring Cell

Start a blank test of the analytical unit according to the frequency set in the system
so that the measuring cell can enter the normal state.
Before restarting the device when it has been left unused for a long period time, it is
suggested to perform this maintenance.
6.2.6. Maintaining the Measuring Cell

First fill the liquid line of aspiration probe with system water, and fill the measuring
cell with system reagent (Buffer solution). Before the device is shut down and
unused for some time, this maintenance must be performed.
6.3. Scheduled Maintenance

6.3.1. Daily Maintenance
Cleaning the probes
Dirt on the reagent/sample probe or the aspiration probe may result in
contamination or residue and further affect test results. In order to prevent
contamination, the probes should be cleaned daily.
Table 6-2 Cleaning the probes
Precautions
Turn off the “Main Unit” power switch of the device;
Wear proper protective gloves;
Take care not to damage the probes;
Materials needed
Clean gauze;
Distilled water or deionized water;
70% alcohol;
Operation process
1. Power off the device;
2. Move the probes to an area allowing easy operation;
3. Wipe the external surface of probes with gauze soaked in
69
alcohol; then wipe the surface with gauze soaked in distilled

water;
4. Switch on the device and use it after normal startup.
6.3.2. Weekly Maintenance

Cleaning the reaction tray
Liquid leakage on the reaction tray may result in adhesion among assay cups, so it
is necessary to clean this component on a regular basis.
Table 6-3 Cleaning the reaction tray
Precautions
Materials needed
Clean gauze;
70% alcohol;
Cotton swabs;
Operation process
2. Remove the protective cover of reaction tray;
3. Use cotton swabs dipped with distilled water or deionized
water to wipe assay cup holes of the reaction tray one by
one;
4. Wipe the surface of reaction tray with gauze soaked in
alcohol; then wipe the surface again with gauze soaked in
distilled water or deionized water;
5. Put the reaction tray back in the original position;
6. Switch on the device.
Cleaning the cleaning cells

There are a cleaning cell used to flush the reagent/sample probe and a cleaning cell
used to flush the aspiration probe. Dirt in the cleaning cells may result in residue. In
order to prevent contamination, the cleaning cells should be cleaned weekly.
Table 6-4 Cleaning the cleaning cells
Precautions
It is forbidden to use alcohol to wipe.
Materials needed
Clean gauze;
70% alcohol;
Cotton swabs;
Operation process
70

2. Move away the robotic arm of each probe;
3. Use cotton swabs dipped with distilled water or deionized
water to wipe the cleaning cells;
4. Switch on the device.
Cleaning the measuring cell

Contamination in the measuring system may reduce the accuracy and precision of
sample tests or even block the measuring channel. In order to keep the measuring
liquid channel clean and maintain the performance of the measuring cell, the
measuring cell should be cleaned at least once two weeks or 2500~3000 tests.
Table 6-5 Cleaning the measuring cell

Precautions
Materials needed
Measuring cell maintenance buffer
Auffer Cleaning Solution
Operation process
1. Remove the Auffer cleaning fluid from the system reagent
cartridge and put measuring cell maintenance buffer.
2.Click [General maintenance] -> [maintenance] ->
[Measuring cell maintenance]. It takes half an hours for the
performance to completed.
3. Replace the measuring cell maintenance buffer with
Auffer positions.
4.Start 10 times blank tests.
5. Complete the performance of the maintenance process.
6.3.3. Monthly Maintenance

Replacing the pinch valve hoses
Liquid leakage may be caused if old pinch valve hoses are used, further affecting
the accuracy of pipetting volume. Therefore, the hoses should be replaced at least
once every three months.
6.4. On-demand Maintenance

Long standby maintenance
After the “finalization” operation, the device is allowed to keep unused for several
hours (e.g., overnight). In the “finalization” operation, fill the liquid channel of the
device with water, and fill the measuring cell with system reagent (Buffer solution).
Before entering the standby state, the device will automatically perform the
“finalization” operation. If the “finalization” operation is not automatically performed
(due to emergency stop, for example) or cannot be performed (when an alarm is
generated, for example), or the system remains unused for several hours, manual
finalization must be performed.
71
Cleaning the system water container

Contamination of the system water container will affect the performance of the
analyzer. Clean the system water container as needed.
Liquid container or direct drain pipeline
Check and empty the waste liquid container as needed. If the waste liquid container
is full, an alarm will be generated, and operation of the analyzer will be interrupted.
This requirement applies to the internal waste liquid container and can be ignored if
a direct drain pipeline is used.
Cleaning the system reagent cartridge
Clean the system reagent cartridge when necessary to eliminate leakage or residue
of Buffer solution and Auffer cleaning solution.
Protecting the measuring cell during long shutdown
If the device is to be left unused for more than 7 days, it is very important to properly
prepare the system and carry out shutdown maintenance. Ignorance of these
suggestions may cause damage to the measuring cell. Depending on the shutdown
period, different shutdown steps are recommended.
6.5. Unscheduled Maintenance

Replacing the reagent/sample probe
1. Use a Phillips screwdriver to remove the Z-axis cover of 3D robotic arm;
2. Apply force counter-clockwise to remove the flanged edge joint on the
reagent/sample probe;
3. Unplug the reagent/sample probe from the liquid level detection plate;
4. Use a Phillips screwdriver to loosen the pan-head machine screw on the
copper-colored probe clamping block;
5. Take out the used reagent/sample probe, and insert the new reagent/sample probe
into the probe clamping block;
6. Tightly lock the pan-head machine screw on the copper-colored probe clamping
block;
7. Insert the joint on the reagent/sample probe to the liquid level detection plate;
8. Connect the flanged edge joint to the reagent/sample probe;
9. Enter the operation interface; select [System Reset] in the [Routine Maintenance]
column;
10. After confirming that the reagent/sample probe works normally, install the Z-axis
cover of 3D robotic arm.
72
Fig. 6-1 Replacing the reagent/sample probe
Steps for replacing the aspiration probe

1. Use a Phillips screwdriver to remove the Z-axis cover of 2D robotic arm;
2. Apply force counter-clockwise to remove the flanged edge joint on the aspiration
probe;
3. Unplug the aspiration probe from the liquid level detection plate;
4. Use a Phillips screwdriver to loosen the pan-head machine screw on the
copper-colored probe clamping block;
5. Take out the used aspiration probe, and insert the new aspiration probe into the
probe clamping block;
6. Tightly lock the pan-head machine screw on the copper-colored probe clamping
block;
7. Insert the joint on the aspiration probe to the liquid level detection plate;
8. Connect the flanged edge joint to the aspiration probe;
9. Enter the operation interface; select [System Reset] in the [Routine Maintenance]
column;
10. After confirming that the aspiration probe works normally, install the Z-axis cover of
2D robotic arm.
73
Fig. 6-2 Steps for replacing the aspiration probe
Replacing the pinch valve hoses

1. Prepare 2PCS of new180mm silicone hose;
2. Disconnect the used silicone hoses from the brown pagoda joints on the measuring
adapter block;
3. Connect the new silicone hoses respectively to the upper and lower pagoda joints;
4. Clamp the silicone hoses inside the corresponding pinch valve;
5. Replacement of silicone hoses is finished.
a. TAKASAGO brand pinch valve
74
b. Bio-Chem brand pinch valve
Fig. 6-3 Replacing the pinch valve hoses
Replace the measuring cell

1. Before replacement of the measuring cell, it is necessary to confirm that the device
has been disconnected from power supply, and that the measuring unit is not
exposed to strong light;
2. Use a Phillips screwdriver to loosen the combination screw in the upper cover of the
measuring unit, and remove the upper cover of the measuring unit;
3. Use a Phillips screwdriver and an Allen key to respectively loosen the combination
screw in the external side of the pulling plate and the hexagon socket limit screw in
the sliding block;
4. Apply force counter-clockwise to remove the liquid inlet and outlet pipes connected
to the measuring cell;
5. Unplug the measuring cell and the photomultiplier tube from the amplifier PCBA;
6. Take out the sliding block; use a Phillips screwdriver to loosen the combination
screw locking the measuring cell (during operation, it is forbidden to touch the mirror
surface of photomultiplier tube, or to expose the mirror surface of photomultiplier
tube to strong light, or to directly touch the glass surface of measuring cell);
7. Replace the measuring cell on the sliding block assembly with the prepared one;
8. Install the sliding block assembly into the measuring unit;
9. Plug the measuring cell and the photomultiplier tube into the amplifier PCBA;
10. Respectively connect the liquid inlet and outlet pipes to the measuring cell;
11. Use an Allen key to lock the hexagon socket limit screw in the sliding block, and use
a Phillips screwdriver to lock the combination screw in the pulling plate, thus to fix
the sliding block assembly;
12. Use a Phillips screwdriver to lock the upper cover of the measuring unit, thus to
finish the replacement of measuring cell.
75
Fig. 6-4 Replacing the measuring cell
Replacing the system water bucket

1. System water preparation;
A. Add to deionized water in clean system bucket, until the capacity is 9 liters(Refer to
the scale line on the water bucket);
B. Then add 1 liter of Concentrated Washing Buffer into the system bucket.
C. Cover the lid with system water and stand aside for a day.
2. Twist off the bottle lid of the system water for use.
3. Put the float sensor assembly of the instrument into system bucket and tighten the
bottle cap.
4. Initialize the system of instrument.
Note: the system is allowed to replace the system water only when it is in standby or
shut down.
After replacement of system water, system initialization must be carried out.
76
Fig. 6-5 Replacing the system water bucket
Replacing the waste liquid bucket

1. Loosen the cap on the waste liquid bucket;
2. Take the float sensor assembly out of the waste liquid bucket;
3. Put the float sensor assembly in the waste liquid bucket, and tighten the cap.
Fig. 6-6 Replacing the waste liquid bucket
Changing the printing paper

1. Open the housing of the printer;
2. Put the printing paper in the printer;
3. Press the printer with the roller on the housing of the printer;
4. Close the housing to finish the change of printing paper.
Fig. 6-7 Changing the printing paper
77
6.6. Maintenance Log

Table 6-6 Daily Maintenance Log
Maintenance Log
(MM/YYYY)
Maintenance items (daily) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Checking the waste liquid bucket and its
1
connection
2 Cleaning the reagent/sample probe
3 Cleaning the aspiration probe
Operator
Table 6-7 Weekly Maintenance Log
Maintenance Log
(MM/YYYY)
Maintenance items (weekly) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Cleaning the reaction tray
2 Cleaning the cleaning cells
3 Cleaning the measuring channel
Operator
Table 6-8 Monthly Maintenance Log
Maintenance Log
(MM/YYYY)
Maintenance items (monthly) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Replacing the pinch valve hoses
Operator
78
Table 6-9 Unscheduled Maintenance Log

Maintenance Log
(MM/YYYY)
Maintenance items (weekly) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Long standby maintenance
2 Cleaning the system water container
3
Operator
79
80
eCL 8000 User Manual Chapter 7 Alarms and Troubleshooting
Chapter 7 Alarms and

Troubleshooting
 7.1 Overview
 7.2 Alarm Classification
 7.3 Alarm Level
 7.4 Fault category
 7.5 Alarm viewing and Troubleshooting
 7.6 Fault Code Table
7.1. Overview
This chapter introduces troubles, the reasons of the troubles, the Solutions to solve
the troubles. Please carefully read to ensure proper use and optimum performance
81
of the device and safety of the operator.
7.2. Alarm Classification

An notification sends to user, when troubles occurs during the instrument working.
Table 7-1 Alarm Classification
Alarm
Illustrate
Classification
When the data Alarms occurred, the state of instrument
Data Alarms maybe abnormal, e.g. Insufficient-sample 、
insufficient-reagent.
Instrument This type of alarm occurred, there are some fatal
Trouble malfunctions in the instrument, such as mechanical trouble.
7.3. Alarm Level

According to the different processing methods of troubles, there are three defined
alarm levels. The details are shown in the following table.
Table 7-2 Alarm Level
Alarm Type Alarm Level Illustrate
This level trouble occurred, the instrument

will finished movement of all mechanisms
STOP STOP in this cycle. The results of the testing
sample cannot be obtained and the test
must be retested.
This type alarms occur, all mechanisms
stop moving. The results of the testing
E.STOP E.STOP
sample cannot be obtained and the test
must be retested.
This alarm corresponds to the event of the
instrument. After the event, the instrument
S.STOP S.STOP
stops sample loading and the instrument
does not stop running.
This type of warning is a failure of the
data .When the Alarms occur, the
Warn WARN instrument does not stop run by itself, the
operator should judge whether to keep on
or stop the test.
7.4. Fault- Category

According to different modules and parts，faults are divided. The details are shown
in the following table.
82
Table 7-3 Trouble Category
No Module Module code

00-Operating System
01-User Software
03-Database
01 Host system 04-LIS Communication
05 - Network
06-Power State
07-Machine State
00-3-Dimensional robotic Arm Unit
01-Sample Unit
pretreatment 02-Fluid Unit
02
system 03-Immunoreagent Unit
04-Incubation Unit
05-Communication Unit
00-2-Dimensional robotic Arm Unit
01- System Reagent Unit
03 Analysis System 02-Fluid Unit
03-Measuring Unit
04 COP Unit
01-IAP Download Unit
7.5. Alarm viewing and Troubleshooting
83
7.6. Fault Code Table

Table 7-4 Fault Code table
Fault Code Unit Level Fault Name Fault Description Remedy/Solutions
Operating There is a problem with the 1.Call local technical support for
01-00-001 E.Stop Database disconnected
System database connection assistance.
Operating The database version is 1.Call local technical support for
01-00-002 E.Stop Incorrect database version
System incorrect. assistance.
Operating The software is not authorized 1.Call local technical support for
01-00-003 E.Stop NO authorized
System to run on this computer. assistance.
1. Delete some unnecessary files,
Operating Insufficient space for the The hard disk's spare space is
01-00-004 Warn 2. If the fault is not solved, please call
System remaining hard disk not enough.
local technical support for assistance.
1. Restart system.
Operating 2. Check the relevant port and cable.
01-00-005 Warn LIS Disconnected LIS connection failed.
System 3. If the fault is not solved, please call
Operating 1.Please call local technical support
01-00-006 Warn Unkown BUG Unknown BUG occur
System for assistance.
1. Restart system.
Peripheral Failed to open serial Failed to open Serial 2. Check the relevant port and cable.
01-10-001 E.Stop
Equipment communication communication 3. If the fault is not solved, please call
1. Restart system.
Peripheral 2. Check the relevant port and cable.
01-10-002 Warn Failed to open LIS serial port Failed to open LIS serial port
Equipment 3. If the fault is not solved, please call
84
1. Restart system.
01-10-003 Warn Failed to open barcode scanner Failed to open barcode scanner
1. Restart system.
01-10-004 Warn Failed to active the printer Failed to active printer
1. Restart system.
01-10-005 Warn Failed to open the RFID reader Failed to active the RFID reader
1. Restart system.
2. Check the relevant port and cable.
01-11-001 System E.Stop Slaver system failed to start Slaver system failed to start
3. If the fault is not solved, please call
1. Restart system.
01-11-002 System Warn General-purpose fault General-purpose fault
1. Restart system.
01-11-003 System E.Stop General-purpose fault General-purpose fault
85
1. Restart system.
01-11-004 System E.Stop General-purpose fault General-purpose fault
1. Restart system.
Communicatio
01-20-001 E.Stop System communication failed System communication failed 2. If the fault is not solved, please call
n Unit
1. Restart system.
Communicatio
05-20-001 E.Stop Communication failed Communication failed 3. If the fault is not solved, please
n Unit
call local technical support for
assistance.
1. Restart system.
Communicatio
05-20-002 E.Stop CRC Error CRC Error 2. If the fault is not solved, please call
n Unit
1. Restart system.
Communicatio
05-20-003 E.Stop Unknown command Unknown command 2. If the fault is not solved, please call
n Unit
1. Restart system.
Communicatio
05-20-004 E.Stop Communication buffer overflow Communication buffer overflow 2. If the fault is not solved, please call
n Unit
1. Restart system.
Communicatio 2. If the fault is not solved, please
05-20-005 E.Stop Other Error Other Error
n Unit call local technical support for
assistance.
3D robotic The X-motor did not reach or 1.Check detector signal and replace if
06-00-001 E.Stop X motor malfunction
Arm Unit move out of the home position . defective.
86
2.Replace motor.
3.Restart system or execute initialized
program initialize the system.
4.If the fault is not solved, please call
1.Check detector signal and replace if
defective.
The Y-motor did not reach or 2.Replace motor.
3D robotic
06-00-002 E.Stop Y motor malfunction move out of the home 3.Restart system or execute initialized
Arm Unit
Position. program initialize the system.
defective.
The Z-motor did not reach or 2.Replace motor.
3D robotic
06-00-003 E.Stop Z motor malfunction move out of the home 3.Restart system or execute initialized
Arm Unit
position. program initialize the system.
defective.
3D robotic 2.Restart system or execute initialized
06-00-004 E.Stop S/R probe is hampered S/R probe is hampered
Arm Unit program initialize the system.
3D robotic The X-motor does not work, or 1.Check detector signal and replace if
06-00-005 E.Stop X-motor Failure
Arm Unit is not working properly. It is defective.
87
bunged up with something, 2.Replace motor.

did not reach or stop at 3.Restart system or execute initialized
the position correctly. program initialize the system.
4.If the fault is not solved,please call
The Y-motor does not work ,or defective.
is not working properly. It is 2.Replace motor.
3D robotic
06-00-006 E.Stop Y-motor Failure bunged up with something, 3.Restart system or execute initialized
Arm Unit
did not reach or stop at program initialize the system.
the position correctly. 4.If the fault is not solved, please call
The Z-motor does not work ,or defective.
3D robotic
06-00-007 E.Stop Z-motor Failure bunged up with something, 3.Restart system or execute initialized
Arm Unit
1.Check detector signal of motors and
replace if defective.
3D robotic The motors of the X collided 2.Restart system or execute initialized
06-00-008 E.Stop X-axis motors collided
Arm Unit during working. program initialize the system.
The pipetter does not detect a 1.Check the volume of test sample,
06-01-001 Sample Unit Warn Insufficient-Sample
liquid level at the sample replace if not enough.
88
position. The test sample is 2.If the fault is not solved,please call
insufficient or empty. local technical support for assistance.
1.Check the test sample,Remove
Sample pipetter hovering,
bubbles if have.
06-01-002 Sample Unit Warn Bubbles in the sample maybe bubbles in the test
sample.
S/R probe is hampered when 1. Check water conductivity.
pipetting sample. Maybe The 2. Replace pipetter probe.
S/R probe is hampered when pipetter does not detect a liquid 3. Check sample volume.
06-01-003 Sample Unit Warn
pipetting sample level at the sample position, or 4. Check sample position.
the pipetter stop at the 5. If not solved, call local technical
position correctly. support for assistance.
1.Check pressure sensor and replace
if defective.
The sipper pressure sensor 2.Check sample, removed blood clots.
Liquid Flow
06-02-001 Warn Abnormal Pressure detected an abnormal status 3.Restart system and clean the
System
when pipetting. pipetting liqiud Flow system.
4.If not solved, call local technical
support for assistance.
defective.
2.Replace motor.
Liquid Flow Controller error signal for the
06-02-002 E.Stop 500uL plunger pump error 3.Restart system or execute initialized
System plunger pump is detected
89
1.Check the system water, exchange if

not enough.
Liquid Flow defective.
06-02-003 Warn System water short The System water is short.
System 3.Restart system or execute initialized
1. Check liquid waste level, empty if
full.
Liquid Flow 2. Check liquid waste detector
06-02-004 Warn Waste bucket is full The liquid waste bucket is full.
System signal, and replace if defective.
1. Check liquid waste level, empty if
full.
Liquid Flow 2. Check liquid waste detector
06-02-005 Warn liquid waste tank is full The liquid waste tank is full.
System signal, and replace if defective.
1.Check system water level.
2.Check distilled water detector signal,
Liquid Flow The level of the distilled water
06-02-006 E.Stop No system water and replace.
System goes down and is short.
The assay reagent is short for 1. Check assay reagent volume.
06-03-001 Reagent Unit Warn Reagent Short
Test. 2. Check detector signal, and
90
1.Check RackPack.
Pipetter film was detected on 2.Check detector signal, and replace
06-03-002 Reagent Unit Warn Bubbles in Reagent pipetting of the assay reagent if defective.
for Test. 3.If the fault is not solved, please call
1. Check Enhanced Washing Buffer
The Cleaning Solution is short volume,1.exchange if not enough.
06-03-003 Reagent Unit Warn Cleaning Solution Short
for Test. 2. If the fault is not solved, please call
1.Check reagent Film, Remove if not.
2.Check the reagent volume.
S/R probe is hampered when 3.Check detector signal, and replace
06-03-004 Reagent Unit Warn S/R probe hampered
pipetting reagent. if defective.
1.Change the reagent.
The Reagent for the test is
06-03-005 Reagent Unit Warn Reagent overdue 2.If the fault is not solved, please call
overdue.
The mixing time of reagent is 1. Wait for the mixed complete.
Reagent Reagent mixing time
06-03-006 Reagent Unit Warn insufficient, please wait for a 2. If the fault is not solved, please call
insufficient
moment. local technical support for assistance.
The incubation disk did not 1. Check home position detector and
06-04-002 Incubation unit E.Stop Incubation motor Failure reach or stop at the home replace if defective.
position while the instrument 2. Remove any blockages.
91
was resetting itself. 3.Restart system or execute initialized

1.Check the environment temperature,
it should be between 10℃ and 30℃.
2.Check the thermistor, replace if
The temperature of the
defective.
06-04-003 Incubation unit Warn Incubation Temperature high incubator exceed the tolerance
3.Check the heater, replace if
limit for 30 min or more.
defective.
The temperature of the
Incubation Temperature Too defective.
06-04-004 Incubation unit Warn incubator exceed the tolerance
Low 3.Check the heater, replace if
limit for 30 min or more.
defective.
1.Check the front cover status, close if
open.
06-06-001 System Unit Warn Front cover is opened Front cover is opened.
2.Check the detector and replace if
defective.
The communication between 1.Check the relevant port and cable.
Communicatio
06-20-001 E.Stop Salver Communication Failure the salvers and masters is 2. Restart system.
n Unit
failed. 3. If the fault is not solved, please call
92
1.Check the relevant port and cable.

Communicatio The CRC of communication is 2. Restart system.
06-20-002 E.Stop CRC Failure
n Unit inaccuracy. 3. If the fault is not solved, please call
1.Restart system.
Communicatio
06-20-003 E.Stop Unknow Command Unknow Command 2. If the fault is not solved, please call
n Unit
1. Restart system.
Communicatio
n Unit
1. Restart system.
assistance.
Communicatio Communication timeout 2. Restart system.
06-20-006 E.Stop Timeout
n Unit detected 3. If the fault is not solved, please call
1. Check the environment
temperature, it should be between
10℃ and 30℃.
Environment temperature too The temperature of
06-60-001 System Unit Warn 2. Check the detector, replace if
high. Environment is too high.
defective.
93
1. Check the environment

temperature, it should be between
10℃ and 30℃.
Environment temperature too The temperature of
06-60-002 System Unit Warn 2. Check the detector, replace if
low Environment is too high.
defective.
1.Check the detector, replace if
The temperature detector is defective.
06-60-003 System Unit Warn Temperature sensor defective
defective. 2.If the fault is not solved, please call
1.Check count detector signal and
2D robotic Sipper is hampered, during 2.Restart system or execute initialized
07-00-001 E.Stop Sipper hampered
Arm Unit level check. program initialize the system.
1.Check home position detector
signal, and replace if defective.
The X motor did not move out of
2. Replace the motor.
2D robotic the home position or reach to
07-00-002 E.Stop X motor malfunction 3.Restart system or execute initialized
Arm Unit the home position while the
instrument was resetting itself.
The X-motor does not work ,or 1.Check detector signal and replace if
2D robotic
07-00-004 E.Stop X-motor Failure is not working properly. It is defective.
Arm Unit
bunged up with something, 2.Replace motor.
94
did not reach or stop at 3.Restart system or execute initialized

the position correctly. program initialize the system.
The Z-motor does not work ,or defective.
2-D robotic
07-00-005 E.Stop Z-motor Failure bunged up with something, 3.Restart system or execute initialized
Arm Unit
1.Check detector signal of motors and
2-D robotic The motors of the X collided 2.Restart system or execute initialized
07-00-006 E.Stop X-axis motors collided
Arm Unit during working. program initialize the system.
1. Check home position detector
The magnet motor did not reach
or stop at the home position
07-01-001 measuring unit E.Stop Magnet Drive Failure 2. Replace the motor.
while the instrument was
resetting itself.
95

The temperature of
Temperature of measurement defective.
07-01-002 measuring unit Warn measurement unit exceeds the
unit is too high 3.Check the Peltier, Replace if
tolerance limit.(28+0.5℃)
defective.
The temperature of
Temperature of measurement defective.
07-01-003 measuring unit Warn measurement unit exceeds the
unit is too low 3.Check the Peltier, Replace if
tolerance limit.(28-0.5℃)
defective.
1. Check status of fan, replace if
Fan of measurement is defective.
07-01-004 Measuring unit E.Stop Fan of measurement unit Failure
1. Check status of tempreture sensor.
Tempreture sensor of Tempreture sensor of
07-01-005 Measuring unit Warn 2. If not solved,please check with
measurement unit is not found measurement unit is not found
service support.
1. Please check the instrument project
reagents, system reagents, reaction
07-01-006 Measuring unit Warn Test signal value is abnormal Test signal value is [s]
cups, system water status to ensure
that the reagents and consumables
96
are in good condition;

2. perform routine maintenance ->
measurement pool preparation -> 5
times of execution, check the alarm
status;
3. normal shutdown, start the test after
rebooting, if the problem is still, please
inform the maintenance staff.
1. Please check the instrument high
voltage adjustment, linear calibration
07-01-007 Measuring unit Warn Test baseline value is abnormal Test baseline value is [s] signal range;
2. If the problem is still there, please
1. The background signal of the
instrument measurement unit is
abnormal;
2. Please check whether the system
Background signal value is
07-01-008 Measuring unit Warn Background signal value is [s] reagent is invalid, replace the buffer
abnormal
cleaning solution, and check the water
condition of the system;
1. Please check whether the system
reagent is invalid, replace the buffer
Measuring cell background Measuring cell background
07-01-009 Measuring unit Warn cleaning solution, and check the water
signal CV abnormal signal CV
condition of the system;
2. Check the maintenance log,
97
whether to maintain the measuring

pool as required, and replace the
silicone tube of the pinch valve;
defective.
2.Replace motor.
Liquid Flow Controller error signal for the
07-02-001 E.Stop 5ML plunger pump error 3.Restart system or execute initialized
System plunger pump is detected
1、Check the volume of buffer, and
change if short.
07-03-001 Reagent Unit E.Stop Buffer is short, less than 3% Too few Buffer, less than 3%
2、If the fault is not solved, please call
Hovering on the buffer.(The 1.Check the volume of buffer.
07-03-002 Reagent Unit Warn Buffer overmuch LLD function fails or the 2.If the fault is not solved, please call
volume overmuch) local technical support for assistance.
1.Check the volume of auffer, and
change if short.
07-03-003 Reagent Unit E.Stop Auffer is short, less than 3% Too few Auffer, less than 3%
Hovering on the auffer.(The 1.Check the volume of auffer.
07-03-004 Reagent Unit Warn Auffer overmuch LLD function fails or the 2.If the fault is not solved, please call
volume overmuch) local technical support for assistance.
98
1.Load the Buffer.

There is no buffer in the buffer
07-03-005 Reagent Unit E.Stop NO buffer 2..If the fault is not solved, please call
position.
1.Load the Buffer.
There is no auffer in the buffer
07-03-006 Reagent Unit E.Stop No auffer 2..If the fault is not solved, please call
position.
The temperature of Reagent
Temperature of Reagent unit is defective.
07-03-007 Reagent Unit Warn unit exceeds the
too high 3.Check the Peltier, Replace if
tolerance limit.(28 + 2℃)
defective.
Temperature of Reagent unit is defective.
too low 3.Check the Peltier, Replace if
tolerance limit.(28 - 2℃)
defective.
1.Check status of fan, replace if
defective.
07-03-009 Reagent Unit E.Stop Fan of Reagent unit Failure Fan of Reagent is defective.
99

07-03-010 Reagent Unit Warn Temperature sensor Failure
1.Check the volume of buffer, and
The Buffer is short,less than change if short.
07-03-011 Reagent Unit Warn Buffer is short，less than 10%
10%. 2.If the fault is not solved, please call
1.Check the volume of auffer, and
The Auffer is short,less than change if short.
07-03-012 Reagent Unit Warn Auffer is short，less than 10%
10%. 2.If the fault is not solved, please call
07-04-001 System Unit E.Stop Measure start fail Fail to start testing
1.Check the connector and PCB
contact.
07-06-001 Measure Unit E.Stop Abnormal ADC detected Abnormal ADC detected
The communication between
Communicatio 2. Restart system.
07-20-001 E.Stop Communication Failure the salvers and masters is
n Unit 3. If the fault is not solved, please call
failed.
100

1.Restart system.
Communicatio
n Unit
1. Restart system.
Communicatio
n Unit
1. Restart system.
assistance.
1.Check home position detector
The mix-motor did not reach or
stop at the home position while
08-00-001 Reagent Unit E.Stop Mix-motor Failure 2. Replace the motor.
the instrument was resetting
itself.
The temperature of assay
Temperature of assay Reagent defective.
08-00-002 Reagent Unit Warn Reagent unit exceeds the
unit is too high 3.Check the Peltier, Replace if
tolerance limit(12℃).
defective.
101

Temperature of assay Reagent defective.
unit is too low 3.Check the Peltier, Replace if
tolerance limit(4℃).
defective.
Fan 1 of assay Reagent unit Fan 1 of assay Reagent is defective.
08-00-004 Reagent Unit E.Stop
Failure defective. 2.If the fault is not solved, please call
Fan 2 of assay Reagent unit Fan 2 of assay Reagent unit defective.
08-00-005 Reagent Unit E.Stop
Failure Failure. 2.If the fault is not solved, please call
08-00-006 Reagent Unit Warn Temperature sensor Failure
1. Check short circuit of DC line.
Communicatio 2. Replace DC power supply.
08-02-004 Warn Power Supply Abnormal Power Supply is out of the limit.
n Unit 3. If the fault is not solved, please call
The communication between 1.Check the relevant port and cable.
Communicatio
08-20-001 E.Stop Communication Failure the salvers and masters is 2. Restart system.
n Unit
failed. 3. If the fault is not solved, please call
102

1.Restart system.
Communicatio
n Unit
1. Restart system.
Communicatio
n Unit
1. Restart system.
assistance.
Communicatio Communication timeout 2. Restart system.
08-20-005 E.Stop Communication Timeout
n Unit detected 3. If the fault is not solved, please call
103
eCL 8000 User Manual Chapter 8 Software Description
Chapter 8 Software Description
 8.1 User Interface

 8.2 System
 8.3 Edit
 8.4 Result
 8.5 Reagent
 8.6 QC
 8.7 Fault
 8.8 Appliation
 8.9 Print
104
8.1. User Interface

8.1.1. Main Interface
（4）（5）（7）（6）
（1）
（2）
（3）
Fig. 8-1Main Window
（1）Shut Down （2）Function Interface Area （3）Function Button Area

（4）User Area （5）Fault Info （6）Shortcut Actions
（7）Lis State
1. Shut Down
Contains: Account Management; Exit; Shutdown; restart.
2. Function Interface Area
Display the interface which corresponds to the selected function button or shortcut
button, and perform the operation.
3. Function Button Area
It contains six function buttons, which is used to open the function interface, such
as:
： Apply for test and QC test.
：Click this button ,The pop-up interfaces Show the real-time

status of reagents and assay cups.
：The test results、QC results、adjust results show in the UI.
：Load the immunological reagent and system reagent, apply for
105
Calibration test and perform the calibration.
：Load the quality control , configure quality control items , show

the quality control conclusions and data.
：This function button contains System ,setting, system status,

account management, software version, etc.
4. User Area
Show the current account and system time.
5. Fault information
Show all fault information, and the current fault.
6. Shortcut Actions
：Test start button.
：E. stop/suspend button, If the button is clicked, user can select to stop or
suspend test of sample.
8.1.2. Pop-up Window
（1）
（2）
（3）
Fig. 8-2 Pop-up Window
（1） Title （2） Function area （3） Operating area

1. Title
The information of this area is overview of the pop-up Window.
2. Function area
This area displays the detail data of the function button.
3. Operating area
Operate the current window.
106
8.1.3. Message box
（1）
（2）
（3）
Fig. 8-3 Message box
（1）Title （2）Operating area （3）Info area

1. Title
The level of message.
2. Operating area
Select the appropriate action according to the current MessageNotify.
3. Information area
The detail information shows the icon of the message level.
The detail of message is displayed in the information area.
8.2. System
8.2.1. Overview
This chapter introduces the real-time states of special reagents, system reagents,
assay cups. The details steps of changing assay cups also introduced in this
chapter.
107
8.2.2. Main System Interface
Fig. 8-4 Main System Interface
1. Immunological reagent
The detail states of immunological reagent show in the UI.
1) UI
No.：The number is from 1 to10,which corresponds to the physical location. The
mark of number also shows the detail status of reagent, The details Refer to
[Reagent].
Item name: The name of item which correspond the current reagent is displayed.
Expired date: The deadline of adjusting reagent (generally 30 days after successful
calibration) is displayed,it becomes red if expired.
Time: The time of the reagent loading(generally 30 min) is displayed in UI, the status
will change white from red,when the time reached.
Remaining times:The remaining times of the reagent display in UI.The reagent state
becomes red when it is less than 10 times. When used up, the status of reagent
becomes "Use up".
2. Assay cups
1) Incubator
The reaction tray is divided into zones A, B, C and D; a set of 25 assay cups can be
placed in each zone (100 assay cups in total). each zones has two status:
 Existence：There are assay cups in the region.
 Inexistence：There are No assay cups in this region.
2) Assay cup State
useable, using, charging, useup.
108
3) Changing Assay cups

In the assay cups changing interface, select the zone where cups are to be changed
or loaded;The corresponding zone of the reaction tray will move to the loading zone;
Remove the used cups; in case of absence of cups, skip this step;Place a new cup
set in the loading zone, and click [Save];To further change or load assay cups in
other zones, please repeat above steps.
Fig. 8-5 Changing Assay cups
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8.2.3. System Reagent

Table 8-1 Illustration of system reagent state
System
Function Illustration Meaning Measure
reagent
Not loaded or Loading or changing with

used up new Buffer solution
Buffer solution
used to transfer
Buffer
test liquid to the
measuring cell
Normal None
Cleaning Not loaded or Loading or changing with

solution used to used up new Auffer solution
clean the
Auffer
aspiration probe,
analytical liquid
line and
Normal None
measuring cell
Enhanced
Washing Buffer Loading or changing with
Not loaded or
Clean used to clean the new Enhanced Washing
used up
reagent/sample Buffer
probe
Cleaning the Normal None

System
reagent/sample
water
probe Used up Replenishing system water
Not full None

Waste liquid
Waste liquid
after test
Discharging the waste
Full
liquid
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8.3. Test Sample Application

8.3.1. Overview
This chapter introduces how to operate the sample test, the QC test and the
additional test, review the parameters of sample or QC.
8.3.2. Sample Application
Fig. 8-6 Sample Edit
1. UI description
1) Mode
Normal Mode:Enter the sample ID which can consist of digits or a combination of
letters and digits;
Barcode Mode:When the sample rack is inserted, the device will automatically read
the sample ID;
Online mode: Acquiring edited sample info issued by the LIS.
2) No.
The prefix and start number consists the sample ID,It Usually be numbered
automatically.
3) Autonumber
Select the sample frame,then check [Autonumber]. The system will numbered the
sample ID by itself.
4) Sample frame state
 Physical state:
none：No sample frame in position of sample frame.
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Idle： There is a sample frame but no sample start up test in frame.

 Test state:
none：No sample frame in position of sample frame.
Idle：There is a sample frame but no sample start up test in frame.
Testing：The sample is testing in the sample frame.
Aspirate sample Finished: Finished all operation of aspirate in the sample frame.
Finished: finished all test in the sample frame.
5) Sample state
None : default state.
Unedited: The number has been edited, but does not edit the test information.
Edited: The sample has been edited, waiting for test.
Testing：The current sample is testing.
Finished：The test is finished, there is no error occurred during the test.
Error：An error occurs during the test.
6) Sample review
Review the detail of the sample. The details display on the right.
2. Function description
1) Acquisition
It is used for obtain the information of the patient or sample from the Lis.
2) Sample Edit
Select the sample frame or sample, click [Sample Edit], the following interface will
pop-up:
Fig. 8-7 Sample Application
 Single sample Application

Selected the sample, then enter the sample ID. The test Item, dilution ratio ,test
times and etc parameters will be setted.
 Batch sample edit
Number the sample of the select sample frame, then select the samples(select by
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drag the mouse or touch). And then set the test Item, dilution ratio ,test times and
etc parameters.
3) Sample delete
Select one or more sample ,click [Delete]. The testing sample can not be delete.
4) Sample Frame delete
Select the sample frame,click[Delete], The status of the frame back to Idle.The
testing sample frame can not be delete.
5) Patient information
Add patient information for the currently selected sample.
Fig 8-8 Patient information
 Sample information
Sample ID.: The number of the current sample.
Position：The location of the sample.
Status:The Status of the sample (Unedit、edit、testing、finish、Error).
Types：The type of the sample,such as Serum, plasma, urine, amniotic fluid,and etc.
 Patient information
Patient ID：The ID of the patient.
Insurance No.:The health insurance number of patient.
Sex: The Sex of the patient.
Age: The age of the patient.
Nation:The nation of the patient.
Patient Type :The type of patient.
Bed No.: The bed number of Patient.
Department: The department of the patient.
Send Doctor: The sample which doctor send.
Send Date: The date of inspection of this sample.
Inspection physician: The test doctor of this sample.
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Inspection Date: The inspect date of the sample.

Review physician: This sample result is reviewed by the physician.
Verification comment:The comment of test result for this sample.
Clinical diagnosis:The doctor make the diagnosis for the patient,after reviewed the
test result.
Verification date: The verification date of result.
 Save
Save the current information.
8.3.3. Test Start
After all the samples have been edited, click , the test will be start.
8.4. Results
8.4.1. Overview
This chapter describes the detail of sample test, QC test , calibration test, the results,
printer ,LIS transmission, etc
8.4.2. Current results

The detail information of the test sample, QC and calibration will be show in the UI.
Fig 8-9.Current results
1. UI description
1) Sample information
Sample ID.: The number of the sample.
Position：The location of the sample.
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Property: The property of the sample(Sample, QC, calibration ).

End time: The finish time of this test.
Status: The State of the sample (idle、waiting for test、testing、finish、Error).
2) Item information
Test Status：The status of test. such as idle, waiting for loading , loading, incubating,
waiting for testing, finish, error, unknown.
Time: Show the time of this test.
Item name：The name of the item.
Result: The result of the test.
Unit: The Unit of the result.
Remark: Mark the result of sample, according to the range of the item.
2. Data Manipulation
1) Query
Fig. 8-10 Query
The information can be query by sample ID, attribute, etc.enter the query
criteria ,then click [Query].
Property: The property of the sample(Sample, QC, calibration ).
Test Status: The Status of the test (waiting testing, testing, finish, cancel, Error).
2) Clear
Delete the sample which is tested.
3) Refresh
Refresh to default status.
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4) Sample detail
Fig 8-11 Sample Detail
Item Name:The name of the test item.

Test Status：The status of the test.
R.Position: The Reagent position of the test Item.
Cup pos.: The Cup position of the current test.
End Time:The finish time of the test.
Signal:The signal of the test.
Result:The Result of the test.
Unit:The Unit of the test.
Remarks: Mark the result of sample, according to the range of the test item.
5) Test Detail
Show the details of the test which currently selected.
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Fig 8-12 Test Detail
 Item Detail
Item name:The name of the test item.
Test Status：The status of the test.
R.Position: The Reagent position of the test Item.
Start Time: The start time of the test.
End Time:The finish time of the test.
Cup pos.: The Cup position of the current test.
Signal:The signal of the test.
Result:The result of the test.
Unit:The unit of the test.
Remarks: Mark the result of sample,according to the range of the test item.
Warn Times: The times warn during the test,click[check] for the details.
Auto Remarks: The system remark during the sample test.
 Item Details
The details of the test item. [Reagent]->[Item Info]->[Item Detail].
 Reagent Details
The details of Reagent which is used for test.[Reagent]->[Reagent details].
 Save
Save the information.
 Close
Go back to the previous page.
8.4.3. Result
This section describes the results and operation of sample test.
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Fig. 8-13 common result
118
1. UI Description
 Sample ID.: The number of the sample.
 Position：The location of the sample.
 Start Time: The start time of the test.
 End time: The finish time of this test.
 Status:The Status of the sample.
 Check：The status of result check.
 Send：Whether the result is send to the Lis or not .
2) Item information
 Item name:The name of the test item.
 Result:The Result of the test.
 Unit:The Unit of the test.
 Remarks: Mark the result of sample,according to the range of the test item.
1) Query
Fig. 8-14 Query
The information can be query by patient name,sample No.,etc.enter the query

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 Patient name：The name of the patient.

 Insurance No.:The health insurance number of patient.
 Sample No.:The sample number of patient.
 Types：The type of the sample,such as Serum, plasma, urine, amniotic fluid,and
etc.
 Priority: The priority of sample, (emergency, conventional);
 Inspection date: The finish time of the test.(start time, End time).
2) Refresh
Go back to the First page.
3) Sample Review
According to the result of the sample, the physician make clinial diagnosis or
remarks for the patient.
Fig. 8-15 Sample Review
 Field Description
Sample information
Sample Types：The type of the sample,such as Serum, plasma, urine, amniotic
fluid,and etc.
Sample Status:The Status of the sample.
Review status: The status of the sample(Y, N).
Review physician: The name of the review physician.
Clinical diagnosis:Doctor make the conclusion for patient, according to the result of
the sample,
Review remarks: remarks.
Item information
Item name:The name of the test item.
Result:The result of the test.
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Unit:The unit of the test result.

Result: The result of the sample.
End Time :The finish time of the sample.
Remarks: Mark the result of sample,according to the range of the test item.
 Function Description
Audit: confirm audit.
Disapprove: Cancel the audit and clear the previous audit record.
4) Sample Detail
The details of the current samples or tested items,[results] -> [current results] ->
[sample details].
5) Delete
Delete the selected result.
6) Print
Print the selected sample result.
7) Transmission
Transfers the selected result to the LIS system.
8) Test Detail
The details of the selected Item. [results]-> [current results] -> [test details].
8.4.4. QC Results
The details of the QC result and operation elaborate in the follow chapter.
Fig. 8-16 Qc Result
1. UI Description
1) Quality control sample information
Sample ID: The number of the current quality control sample.
Sample position: The position of the current quality control sample on the sample
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rack.
QC Lot No.:The Lot number of quality control test.
QC level: The level of QC,(H or L).
End Time: The completion time of the current quality control test.
Sample status: The state of the current quality control test, see the current result
module.
Send: Send the QC Result to the LIS.
2) QC item information
Item name: The name of QC test.
Results: The result of the current quality control test .
Unit:The unit of the current quality control test.
Tip: According to the range of the test item, remark the QC result.
1) Query
Fig. 8-17 Data Manipulation
The information can be query by sample ID, QC name, etc.enter the query criteria ,
then click [Query].
Sample ID : The number of the QC test sample.
QC name: The name of the QC test name.
QC Lot No.: The Lot number of the current QC sample.
Test Data: The time of QC test. Include the Start time and end time.
2) Refresh
Go back to previous page.
3) Delete
Delete the select QC result.
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4) QC Details
View detailed parameters for the quality Control sample test, [results]->[Current
Results]->[sample Details].
5) Send
Transmit selected quality control results to the Lis system.
6) Test Details
View the current QC test details, [results]->[Current results]->[test Details].
8.4.5. Calibration results

This chapter describes the results of calibrated tests,and related operation.
Fig. 8-18 Calibrated results
1) UI Description
2) Calibrated sample information
Sample ID: The number of the current calibrated sample.

Sample position: The position of the current calibrated sample on the sample rack.
Item name: The name of the current calibrated test.
Calibrated Lot No.:The Lot number of calibrated test.
Calibrated level: The level of calibrated,(H or L).
End Time:The completion time of the current quality control test.
Sample status: The status of the current calibrated test.
3) Calibrated item information
Test signal: The signal of the current test.

Target Signal:The target signal of the calibration product for the current calibration
test.
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4) Data Manipulation
5) Query
Fig. 8-19 Data Manipulation
The information can be query by sample ID, Calibrated name, etc.enter the query
Sample ID : The number of the Calibrated test sample.
Calibrated name: The name of the Calibrated test name.
Calibrated Lot No.: The Lot number of the current Calibrated sample.
Test Data: The time of Calibrated test. Include the Start time and end time.
6) Refresh
Go back to previous page.
7) Delete
Delete the select Calibrated result
8) Calibrated details
View detailed parameters for the calibrated sample test, [results]->[Current

Results]->[sample Details].
9) Test Details
View the detailed parameters that are tested by the selected calibration item,
[results]->[Current results]->[test details].
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8.4.6. Historical results

Used for importing, exporting and printing sample results.
Fig. 8-20 Historical results
1. Interface description
Sample ID: Sample number of the current sample;
Name: The name of the patient corresponding to the current sample;
Insurance NO.: the medical insurance number of the patient corresponding to the
current sample;
Gender: The gender of the patient corresponding to the current sample;
Time: The test completion time of the current sample;
2) Project information
Project Name: The project name of the project tested in the current sample;
Results: The results of the items tested in the current sample;
Unit: Unit of project results tested by current samples;
Remarks: The results of the items tested in the current sample are higher or lower
than the reference range of this item.
2. Data manipulation
1) Import
Import the backup sample result file and display it.
2) Query
Find and display the input sample number.
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3) Print
Print all the results shown in the current list.
4) Backup files
View the backup files of all sample test results;
8.5. Reagent
8.5.1. Overview
This chapter describes the loading and viewing of the immune reagent, the
application and execution of the reagent calibration.
8.5.2. Reagent information
Fig. 8-21 Reagent information
1. UI Description
2. Reagent
 Pos.：The number is from 1 to10,which corresponds to the physical location.
The mark of number also shows the detail status of reagent, The details Refer to
[Reagent].
useable：In this status,the reagent can used for test.
Warning: if the reagent expires , the waitting time is not full 30 minutes, the reagent
does not calibrates, or remaining times less than 10 times, etc. The status of
reagent becomes warning.
Loading: Reagent is placed on the physical location but not loaded.the information
to the system.
Unknow: other status.
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 Type：Master-salver
There are some items require two of reagents for testing.
Master：Contain the main curve of the reagent.
Salver: Contain no curve of the reagent.
 Name : The name of current reagent.
 Lot No.:The Lot number of reagent.
 Kit No.: The kit number of reagent.
 Status:The Status of the reagent.
Normal: It is indicated that this reagent can be used normally.
Warning: The status indicates that there is something trouble with the reagent ,such
as the current reagent expired, the loading time less than 30 minutes, not calibrated,
the remaining test times less than 10 times.
 Times：The time of reagent loading .
 Remaining times: The remaining test times for the item, if the remaining times is
less than 10 times ,the status of reagent become red.
 Expired Date: The deadline of the current reagent.The status of reagent
becomes red if expired.
 Calibration Status: The status of current reagent calibration, (success, failure), It
becomes red,if failed.
 Use-by Date: The expired date of the current reagent calibration, recalibrated if
expired.
 Use Status: The use status of the reagent .
Using:The background is red.
Idle: The background is white.
1) Reagent details
The details of the reagent currently selected are shown below:
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Fig. 8-22 Reagent details
 Reagent details
Reagent Name: The name of the current reagent.
Item Number: The number of the tested item by the current reagent.
Lot No.:The batch number of the current reagent.
Kit No.: The box number of the current reagent.
R.Position: Where the current reagent is mounted on the instrument.
Reagent status: The status of the current reagent (available, warning, unknown),
and the position number state of the previous interface is consistent.
Date of opening: The first time the reagent is used.
Reagent type: Current reagent type (master, salve).
Production Date: Production date of the current reagent.
Use-by Date: The expiration date of the current reagent.
Calibration Date: Date time of the current reagent calibration.
Cal. Use-by Date: Date of the current reagent calibration expires.
Loading Date:The time of the current reagent was loaded.
Online time: The online time of the current reagent, if it is not full 30 minutes.
Remains: the number of tests remaining for the current reagent.
Reagent Size: The maximum number of tests for the current reagent.
Cal. Status: The calibration status of the current reagent (not calibrated,
successful, failed).
Fit type: The current Reagent calibration method (four parameters, linear, spline,
five parameters).
Cal. Curve ID:The main curve ID (reagent batch number + calibration time) After
calibration of this reagent.
Calibration concentration L: The low target concentration of the current reagent.
Calibration concentration M: The Middle target concentration of the current reagent.
Calibration concentration H: The high target concentration of the current reagent.
Calibration signal L: The low target signal of the current reagent.
Calibration signal M: The Middle target signal of the current reagent.
Calibration signal H: The high target signal of the current reagent.
Diluent Size: The diluent capacity of the current reagent.
 Curve Details
Main curve
Displays the factory main curve data before the current reagent is not calibrated.
128
Fig. 8-23 Main curve
SN：The Number of data points of the factory main curve.

Conc.: The concentration value of each data point in the main curve of the factory.
Signal: The signal value of each data point of the main curve of the factory.
Calibration signal: The signal value of main curve after calibrated. The default value
will show if the reagent does’t been calibrated.
X-Linear: X-axis is the linear coordinate.
X logarithm: x-axis is logarithmic coordinate.
Y-Linear: The y-axis is a linear coordinate.
Y logarithm: The y-axis is the logarithmic coordinate.
2) Working curve
Displays the curve data and calibration details of the current reagent calibration.
129
Fig. 8-24 Working curve
3) Calibration History
Displays all calibration records for the current reagent.
Fig. 8-25 Calibration History
Select: Current curve is main curve if the background red, otherwise white.
 Curve ID: The curve ID of the current curve.
Low value signal 1: The low value of test signal 1 for the current curve.
Low value signal 2: The low value of test signal 2 for the current curve.
Middle value signal 1: The middle value of test signal 1 for the current curve.
Middle value signal 2: The middle value of test signal 2 for the current curve.
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High value signal 1: The high value of test signal 1 for the current curve.
High value Signal 2: The high value of test signal 2 for the current curve.
Low-value deviation: The deviation of the two low value test signal for current curve
relative to the low value of the target signal .
Middle value deviation: The deviation of the two middle value test signal for current
curve relative to the low value of the target signal .
High value deviation: The deviation of the two high value test signal for current curve
relative to the low value of the target signal .
R^2: The fitting coefficient of the current curve.
Calibration time: The calibration time of the current curve.
Activation curve: Activates the curve data selected from the current list as a working
curve, the background of the list becomes red.
Curve Details: The same as the "main curve" interface, shows the calibration details
of the currently selected calibration history curve.
Delete:Deletes the unserviceable calibration history(Unactivated state)
4) Perform calibration
The system used the latest high and low value for the calibration.
Fig. 8-26 Perform calibration

 Calibration History
View all calibration records for the currently selected immune reagent, as described
in [system]->[reagent Details]->[calibration history].
 Calibration
Perform calibration.
131
5) Calibration Application
Fig. 8-27 Calibration Application
6) Select: Select the position of the high value and low value calibrator on the sample
frame, the detail as follow:
Fig. 8-28 Select
7) Cancel calibration application

If you have applied for a calibration test but have not started the test, you can cancel
the calibration request.
8) Recalculation
If the immune reagent is not calibrated before the test applied, all test will have no
results, and after the reagent calibrated, click [Recalculate] ,then the system will
132
recalculate the results for this reagent.

9) Calibration Results
Displays all calibration test results for the currently selected reagent.
Fig. 8-29 Calibration Results
10) Reagent Loading

Before loading any immunological reagent, it is necessary to read reagent info by
approaching the labeled side of the immunological reagent kit to the reagent
scanning area; put the kit in the reagent cartridge after the Reagent Info interface
pops up.
133
Fig. 8-30 Reagent Loading
put the kit in the reagent cartridge,The reagent load successfully after the interface
disappears .
8.5.3. Item information
Fig 8-31 Item information
1. UI Details
1) Item information List
 Current selection: Display the item name of currently selected.
 Auto Find:
2) Item Details
As show [Data manipulation]->[project details].
1) Item Details
The detail of item and item test time sequence display in the interface.
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Fig 8-32 Item Details
 Item parameters
English name: The abbreviative English name of the item.
English name: The name of the item.
Full Name: The full chinese name of the item.
Unit 1: Main unit of result.
Unit 2 and Factor: deputy unit and conversion factor.
Unit 3 and Factor: Deputy unit and conversion factor.
Measurement range: The linear range of the current project.
Sensitivity: reagent detection sensitivity.
Result Precision: The lowest significant number of test results for the current project.
For example, the result accuracy of a project is 3, and the output result rule is
as follows:
When the result is less than 10, the result is displayed with 3 decimal places
after the decimal point. Examples: 3.052 ng/ml, 0.052 ng/ml;
When the result is ≥10 and < 100, the result is displayed with two decimal
places after the decimal point. Example: 10.52 ng/ml;
When the result is ≥100 and < 1000, the result is displayed with a decimal
place after the decimal point. Example: 100.5 ng/ml;
When the result is ≥1000, the result is an integer. Example: 1002 ng/ml,
340102 ng/ml;
When the result precision is 2, it should be reduced by 1 decimal place, and so
on.
Recommended dilution ratio: The recommended dilution ratio for the sample when
testing the current item.
Build tool Name: The tool name of the item file generated.
Build Tool Version: The version of the tool that generated this item file.
Reagent file Version: The version of this item file.
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Remarks: make notes for the item.

Dilution Rate: the dilution ratio allocated by the current project.
 Time sequence
Describes the steps of execution during the current item test.
1) Item Settings
Fig. 8-33 item settings
 Field description
Item list: Displays the item name of all the project files that exist in the local,Enter
the item name in the textbox, the item information will displays on the right.
Current item: The name of the item that is currently selected.
Units: The units for the current test results.
Reference scope: Reference value range settings for the current project.
Quality control rules:The quality control rules setting for the current QC test, see
[Quality control]->[Quality control Settings]->[Quality control rules].
Cleaning: Set the current Item test whether to do high concentration cleaning.
 Function description：
Detailed setup: Custom Reference Conditions and Scope Settings
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Fig. 8-34 Detailed setup
Save: Save parameters for the item.

Cancel: Cancel to save of the modified value for the current item settings parameter.
2) Sort
Fig. 8-35 Sort
Sort the items in the list by mouse ,and then click [OK] to save the information.
137
8.5.4. Combination reagent
Fig. 8-36 The illustration of the Combination reagent
1. UI description
1) Combined item list
Current selection: The item name of currently selected.
Automatic Find: Find the item name based on characters entered.
2) Combination Group details
Current selection: The name of the currently selected combined item.
Remarks: Notes for the currently selected grouped item.
List of items: The list of items for the currently selected grouped item.
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3) Editor for combined items

4) New Combination
Fig. 8-37 New Combination
Combination Name: The name of the new combined item.
Remarks: Added notes for a combined item.
Combined list: A list of items that are added to a combined project.
Item list: List of items.
Emptying: Empties the list of items for the combated item.
Home: Back to the home page of the item list.
Previous: Displays the previous page of the list of items.
Next: Displays the next page of the list of items.
Save: Save the new grouped item and close the form.
Cancel: Do not save the new grouped item and close the form.
5) Delete
Deletes the currently selected group item.
6) Edit
Reedit the currently selected grouped items, the interface same to [new
combination]
7) Sort
Sorts all the combined item names.
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Fig. 8-38 Sort
Sort the items in the list by mouse ,and then click [OK] to save the information.
8.6. Quality control

8.6.1. Overview
This chapter introduces the quality control product loading. How to set QC results
and how to view the QC result statistics also gives a detailed introduction in this
chapter.
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8.6.2. Quality Control Settings
Fig. 8-39 Quality Control Settings
1. UI Description
1) Control material information
QC Name: The name of the current quality control material.
QC Lot No.: The batch number of the current quality control material.
QC Source : the current source of quality control material(lifotronic quality control,
third-party quality control).
Use-by Date: The expiration date of the current quality control product.
2) Quality Control item information
Item Name: The item name of the current quality control material.
Target value 1: Low target value of the current quality control material.
Standard deviation 1: The standard deviation of the current quality control material.
Target value 2: The high value target of the current quality control product.
Standard deviation 2: The standard deviation of the current quality control material.
Unit: The unit of the project currently being tested for quality control
products.
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1) Query
Fig. 8-40 Query
The information can be query by QC Name, QC Lot No, etc.enter the query
QC Name: The name of the Quality control material.
QC Lot No.: Quality control batch number.
QC Status: normal, expired.
QC Source: Lifotronic Quality control material.
2) Refresh
Used to back to initial page.
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3) Quality Control details
Fig. 8-41 Quality Control details
Display the information of the current quality control material and quality control item,
notes can be added for this quality control, click [Save].
4) QC Edit
Fig. 8-42 QC Edit
 Modify
Select any of the items in the item list for the quality control, and the details for this
item will be displayed in the right text box.The detail parameters can be edited.
 Delete
Delete the item which selected in the list of QC items
143
 Save
Click [Save] to save the modified data to the database.
 Add Item
Fig. 8-43 Add item
Item list : A list of quality control items

Checked: Indicates that the current item is added to the quality control list.
Item name: The item name for all items in the current system.
QC rules: whether the instrument can be controlled by the criteria of judgment, the
details as below:
Table 8-2 QC rules
QC rules Description
This rule indicate that a test result in quality control is
1-2s
more than ±2SD, but less than ±3SD
1-3s This rule indicate that QC test result exceed ±3SD
This rule indicates that two consecutive tests of the
2-2s quality control item exceed +2SD or -2SD,such as (Xn,
Xn-1)
This rule indicates that four consecutive tests of the
4-1s quality control item exceed +SD or -SD,such as (Xn,
Xn-1, Xn-2, Xn-3)
This rule indicates that 10 consecutive test results (10
1-0x data) fall on the same side of the target, such as (Xn,
Xn-1 ...). XN-9).
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5) Loading
 Loading by swiping card
Before loading any QC information, it is necessary to read info by approaching the
labeled side of the RF card to the reagent scanning area; See [Quality Control
Details] , then click [Load].
 Manual Loading
Enter the appropriate parameters, click [Load], then the loading is completed, the
QC item must be add for the manual loading QC. click [Quality Control Editor],the
details QC parameters must be save after edited,otherwise it can’t use for QC test.
Fig. 8-44 Manual loading
6) Uninstall
Deletes the currently selected quality control (deletes only the display,the data also
existed in database).
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8.6.3. Quality Control Statistics
Fig. 8-45 Quality Control Statistics
1. UI description
1) Filterable conditions
Item Name: Displays all the item name of local, selects the items which you want to
view, and then the QC rules will display below.
Quality Control Level: Set the level you want to view (Low/High).
Quality Control Month: Set the quality control time (year + month).
QC Lot No.: Set the quality control batch number that you want to view.
Note: Any change to these four conditions will redraw the quality control chart.
2) Quality control result
Displays the information of the single quality control results, The details described in
the upper right area of this graph.
3) Conclusion
QC Conclusion: Display the status of system control (controllable, out of control).
QC Results Statistics: Display average, standard deviation, CV, and number of
results of all results under this condition,the details are shown in the second area on
the upper right of this graph.
1) Quality Control Data
Displays all the quality control results for the current drawing.
2) Previous, Next
Used to move to indicate each quality control result point.
3) Print
See [chapter 8th Software description]->[print]->[Quality control statistic Print
Report].
146
8.7. Faults
8.7.1. Overview
This chapter describes all faults of the instrument,and the solutions for those faults.
8.7.2. Current Fault

View all failures that have occurred since the instrument starting up.
Fig. 8-46 Current Fault
1. UI Details
Module: The current failure of the module (System, DATA, COP, MPU1, MPU2,
MPU3).
Unit: The unit of the current fault (operating system, external equipment,
communication unit, three-dimensional root arm, sample unit, incubation unit,
two-dimensional root arm, measuring unit, Liquid Unit, reagent Unit, System).
Code: The error code for the current failure.
Time: The time when the current failure occurred.
Level: The level of the current failure (Warn, Stop, S_stop, E_stop).
Info.: Basic information about the current failure.
147
1) Query
Fig. 8-47 Query
Enter the query factor,then click [Query].

Module：SYSTEM、DATA、COP、MPU1、MPU2、MPU3。
Leve：Warn、Stop、S_Stop、E_Stop。
Code：The error code for the current failure.
2) Refresh
Back to initial state.
3) Delete
Deletes the selected single fault display without deleting the database.
4) Delete All
Clears all the current failure.
5) Details
View the failure details.
148
Fig. 8-48 The fault details
8.7.3. Fault Log

All failures occurred since the machine was viewed.
Fig. 8-49 Fault Log
1. UI Detail
See [current fault].
149
1) Query
Fig. 8-50 Query
Enter the query factor,then click [Query].

Module: System, DATA, COP, MPU1, MPU2, MPU3.
Level: Warn, Stop, S_stop, E_stop.
Code: Unique encoding for each failure.
Time: The time when the failure occurred (start time, finish time).
2) Refresh
Back to initial state.
3) Failure Details
See [Current Failure]->[failure Details].
8.8. System Application

8.8.1. Overview
This chapter describes the parameters of the system setting.
150
8.8.2. System Setup
Fig. 8-51 System Setup
1. Software Settings
Fig 8-52 Software Settings
1) System Setting
Fade Background: Switch pop-up box transparent shielding layer.
Discharge mode
151
 Bucket discharge: Emissions to the waste barrels

 Direct discharge: Direct emissions to the hospital waste liquid system
Estimate: Set whether to enable Consumables Prediction function
Item Setting: As same to Reagent Information -> Item Info ->Item Setting
Sleep Setting: Setting up A Sleep Plan for Instruments to Reduce Power
Consumption and Operating Noise
2) setting
 MPU1 Needle Cleaning: Set up the loading unit needle automatic cleaning time.
 MPU2 Needle Cleaning: Set up the analysis unit needle automatic cleaning
time.
3) Printer Setup
print method:
 Integrated printer:The printer is Heat-sensitive printer which integrated on the
instrument.
 Per-printer: An external printer.
Printer: Sets the name of the printer which used for print.
Template: Select the Template for External Printing
Auto Printer: Sets whether to print reports automatically after the results are
produced
4) Backup
Backup temporary files for database and software running
2. Dictionary settings
Fig 8-53 Dictionary settings
1) Dictionary Type
Users should use the above dictionary type to set up the commonly used data,
mnemonics, notes in order to facilitate the later use of the instrument.
152
2) Dictionary Data
Data: The data that each dictionary type contains.
Mnemonic: A simple symbol added for each data, easy to use when extracting.
Preset: default setting.
Remarks: Notes.
3) Method
 Add
Enter the corresponding parameters in the text box, click Save,the list will update if
add successful.
 Delete
Deletes the currently selected data.
 Modify
Modify the currently selected data with the following interface:
Fig. 8-54 Alter
Keywords, whether the default is read-only status, click Save to modify the
success and update the list.
153
3. LIS Networking settings
Fig. 8-55 Lis Networking settings
1) LIS enable
Turn on or off the LIS function. when LIS enabled,the following port settings and
protocol settings to be set,otherwise the parameter can’t be setted.
2) Port Settings
 Serial
Set serial port ,baud rate
 Net
IP，Port.
 None
Disable LIS.
3) protocol type
ASTM：The ASTM agreement is a standard for the standard organization of the
American Materials Laboratories Association (ASTM) to transmit information
between medical clinical laboratory instruments and computer systems, which has
multiple versions, and the version mentioned in this article is e1394-97.
4) Host Configuration
Instrument number, manufacturer name.
5) Upload Mode
Auto Upload: After the test is completed, it is automatically uploaded to Lis.
Manual upload: The result module must be manually selected after the click
Transmission.
6) LIS Connection
Set automatically connect power-on or shutdown.
154
4. Time settings
Fig. 8-56 Time settings
Set the current system time, click [Save].

5. Sound setting
Fig. 8-57 Sound setting
Turn on/off prompts, warnings, and errors when they occur.
155
6. Language setting
Fig. 8-58 Language setting
System language Settings, when selected one language,the system language

automatically switches to the language of the current selection.
8.8.3. System Status
Fig 8-59 System Status
156
1. Temperature
Display the real time temperature of each module, if the temperature exceed the
range of the temperature, the background becomes red.
2. Others
Display the status of each module of the instrument in real time.
3. Frame State
Special reagent: the status of the reagent position.
Sample frame: The status of the sample frame.
System reagent: The status of system reagent.
8.8.4. System Information

Software basic information: The basic information contains the instrument number,
software version, boot time ,etc.
Fig 8-60 System Information
157
8.8.5. Routine Maintenance

1. Maintenance
Fig. 8-61 Maintenance
1) System initialization
The system of instrument will reboot.
2) Clean liquid circuit
Clean the whole instrument liquid.
3) Empty liquid circuit
Emptying the liquid of the whole machine.
4) Fill liquid circuit
Fill the liquid of the instrument with the specified liquid.
5) measuring cell Preparation
Perform the preparatory action of the measuring cell.
6) Clean S/R probe
Clean the S/R probe .
7) Enhanced clean S/R probe
Clean the S/R probe by Enhanced Washing Buffer.
8) Clean sipper probe
Clean the sipper probe by specific reagent.
9) Measuring cell maintain
Perform the maintenance timing sequence of the measuring cell.
10) Liquid Packet
Clean the whole machine's liquid path and empty the liquid path side by side for
instrument packaging.
158
11) View History
Fig. 8-62 View History
User: The name of the user that the instrument is logged.
Name: The name of maintain. The detail see [Routine
maintenance]->[ maintenance].
Start time: The start time of the current maintenance.
End time: The completion time of the current maintenance.
Total time :Total time spent on current maintenance (finish – start).
Complete: The current maintenance is successful.
Description: Notes.
Query: User, Name, Time (Maintenance completion time, maintenance records
during a period time).
Refresh: Back to the home page,after executed query.
159
2. Detection
Fig 8-63 Detection
1) Check capacity of reagent

Detects the capacity of four reagents of a specific reagent position.
2 General reagent capacity
Detects buffer/auffer capacity.
3 System Measurement
Measurement unit System pipeline capacity [one less: detection of HC capacity].
2) Check capacity of system liquid
Detects buffer/auffer capacity.
3) Check capacity of clean solution
Testing Needle Strong Cleaning Fluid Capacity
8.8.6. Advanced maintenance

This interface is used for the maintenance engineer, which need higher authority.
160
8.8.7. Instrument statistics

1. Test statistics
Fig. 8-64 Test statistics
Select view type: All, sample, quality control, calibration.

Item Name: Select the item test statistics that need to be viewed, and ignore
the total test volume statistics of the test items.
Set viewing time: The time axis Can be moved or moved by "last month", "next
month"
161
2. Alarm statistics
Fig. 8-65 Alarm statistics
All alarms in the system are classified by the alarm’s type.
8.8.8. User Management

1. User Management
Fig. 8-66 User Management
162
1) Add User
Fig. 8-67 Add user
Enter the parameters in the text box,and click add.

2) Change Password
Fig. 8-68 Change Password
Enter the password for the current user, set the new password, confirm the new
password, and click Change.
3) Delete User
Deletes the selected user from the list of user names.
163
4) Change user
Fig. 8-69 alter User
Enter the current user's password, and to modify the name, click [Change].
2. Login History
Fig. 8-70 Login History
Display all user name and login time of this instrument.The information can be
searched by user name or login time.
164
8.8.9. Help
View Instructions Document
8.8.10. About
1. Manufacturer's information
Fig 8-71 Manufacturer's information
165
2. Software version
Fig 8-72 Software version
8.9. Print
8.9.1. Overview
This chapter describes the details of all the printed reports of the instrument
8.9.2. Sample Results Print Report

The sample results can be printed in the result module of the regular sample
interface.
166
1. Integrated Printer
Fig 8-73 Integrated Printer
167
2. External Printer
Fig 8-74 External Printer
8.9.3. Quality Control Statistics Print Report
Fig 8-75 Quality Control Statistics
168
P/N:07-IA5A001-00002 (A5)
Shenzhen Lifotronic Technology Co., Ltd.

Manufacturer Address: Unit A, 4th Floor, Building 15, Yijing Estate, No.1008 Songbai Road, Nanshan
District, Shenzhen City, Guangdong Province, 518055, P.R.China
Web: www.lifotronic.com
Email:[email protected]

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eCL8000

Fully Automated ECL Analyzer

Chapter 5 Data Transmission..................... 62 8.2.3. System Reagent.............. 110

Intellectual Property Rights

is a trademark or registered trademark of Lifotronic.

Warranty and Repair Services

Authorized European Representative

Symbol Content Meaning

Alerts the operator to operate according to the

Alerts the operator to operate according to the

Prevention of electric shock

 It is forbidden to use this device near sources of intense radiation (e.g.,

Installation and maintenance

Prevention of personal injury from moving parts

Doors/covers of the device

Prevention of personal injury from laser

Prevention of fire and explosion

Disuse of the device

Damage to the measuring unit

Prevention of sample volatilization

Replacement of assay cups

Replacement of sample rack

Replacement of pinch valve hoses

Replacement of immunological reagent

Replacement of system reagent

Disposal of waste liquid

Prevention of electromagnetic interference

 The device conforms to the requirements on emission and immunity to

Third party software

 Some substances contained in immunological reagents, QC materials,

Prevention of chemical hazards

Table 3 List of electromagnetic emission standards

Emission test Compliance

Table 4 List of electromagnetic immunity standards

Immunity test Basic Performance

Safety Signs and Silkscreen Prints

Danger of electric shock by touching

Use Front cover as shown

RS-232 Serial port

System water connector

Waste liquid connector

System water sensor

Waste liquid sensor

System water bucket

Waste liquid bucket

In vitro diagnostic device

Authorized representative in the

Consult instruction for use

Compliance with WEEE Standard

Card swiping symbol

a.c. Alternating current

Main Unit switch

Pay attention to the rain

Prohibit the rolling

Limit of stack layers

*Warning Labels and Meaning：

The pinch valve hoses belongs to

Annex A Names and Contents of Toxic or