User Manual of Aigel 300

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AUTOMATIC BLOOD

GROUPING SYSTEM

USER MANUAL
(for Aigel 100/300)

Released version:Version 1.01


Issue date: 2015.11.20

Changes for this manual are without prior notice.


AUTOMATIC BLOOD GROUPING SYSTEM USER MANUAL

Preface

Introduction
Thank you very much for becoming the user of Automatic Blood Grouping System.
Before performing any work on or with Automatic Blood Grouping System, first read the manual
carefully.
To achieve better results, you have to be familiar with the performance of Automatic Blood Grouping
System before performing any test on it.
Please keep it in good situation after reading, in order to be able to access at any time when needed

Copyright Notice
The copyright of this document is reserved by Ai Kang Medtech Co., Ltd. Any unauthorized copy,
modification and reproduction are forbidden.
◎ 2016-2020Copyright reserve all rights: (China) AiKang Medtech Co., Ltd.

Declaration
Aikang Medtech Co., Ltd. reserves the right of final interpretation of this manual.
In the case meets all of the following requirements, Aikang is considered to be responsible for product
safety, reliability and performance, namely:
■ Assembly operation, expansion, re-adjust, improvement and repair are all performed by professionals
recognized by Aikang.
■ All replacement parts and accessories, consumables are all approved by Aikang.
■Electrical equipment is in line with national standards and the requirements of the manual.
■ Operation is carried out in accordance with this manual.
■This manual is subject to change without notice.

Warranty and maintenance services


Standard warranty period for this product is ONE year; standard warranty period of major accessories is
ONE year, one year starting from the "Installation date" filled on the "Warranty Card", which is
accompanying with product. "Warranty Card" is the only evidence of the warranty period. Within the
warranty period, product can be free to enjoy the after- service. However, warranty does not cover the
following conditions cause the product needs repair,.

■ Man-made damage;
■ Misemploy;
■ Network voltage is exceeding the range of this product;
■ Irresistible natural disasters
■ Replacing or using parts, accessories, supplies without Aikang-approved or maintenance by non
Aikang-authorized personnel;

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AUTOMATIC BLOOD GROUPING SYSTEM USER MANUAL

■ Other failures caused by non-product itself.

After-sales service Operator


After-sales department of Aikang Medtech Co., Ltd
Hotline:+86 8009990929
Tel:+86 0755-25871250
fax:+86 0755-25871281

Warning
●This system is limited operated by the inspection professionals, doctors or laboratory technician, who is
trained by Aikang or Aikang’s agent.
●If each hospital or institution that use this system cannot achieve a satisfactory repair / maintenance plan,
it will likely result in abnormal equipment failure, and even may endanger human health.
●Make sure that operating this system under the conditions specified in the manual. If beyond conditions of
using, the system may not operate properly, and the measurement results will be unreliable and potentially
damaging some parts of this system or even damage to personal safety.

Notice
This manual is intended for the following laboratory professionals:
●Systematic daily operations personnel;
●System maintenance and troubleshooting personnel;
●Learn the system operation personnel.

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AUTOMATIC BLOOD GROUPING SYSTEM USER MANUAL

CONTENT
PREFACE ..................................................................................................................................I
CHAPTERⅠOVERVIEW ...................................................................................................... 1
1.1 TERMINOLOGY ........................................................... 1
1.2 SAFETY REGULATION ...................................................... 1
1.3 SYMBOLS .............................................................. 1
1.4 SYSTEM BASE APPLICATION ................................................. 2
1.5 PURPOSE AND LIMITATIONS.................................................. 3
1.6 SAFETY WARNING AND PRECAUTION............................................. 3
1.6.1 Ordinary Precaution ....................................................................................................................... 3
1.6.2 Check and Confirm ........................................................................................................................ 3
1.6.3 Security of Electricity..................................................................................................................... 4
1.6.4 Risk Factors .................................................................................................................................... 4
1.6.5 Mechanical Hazard ......................................................................................................................... 4
1.6.6 Electric Risk ................................................................................................................................... 5
1.6.7 Chemical and Biological Hazards .................................................................................................. 5
1.6.8 Software Precautions ...................................................................................................................... 5
1.6.9 Manufacturer .................................................................................................................................. 5
1.6.10 CE Conformity ............................................................................................................................. 5
CHAPTERⅡ INSTRUMENT INTENDED USE AND OVERVIEW ............................... 7
2.1 BASIC FUNCTION ......................................................... 7
2.2 BASIC CONFIGURATION ..................................................... 8
2.2.1 Module Configuration .................................................................................................................... 8
2.3 WORKING PROCESS ........................................................ 9
2.4 AUTOMATIC BLOOD GROUPING SYSTEM CONFIGURATION ............................... 9
2.5 SYSTEM MODULE ........................................................ 10
2.5.1 Robot Arm Module....................................................................................................................... 10
2.5.2 Wash Station ................................................................................................................................. 11
2.5.3Tube Rack Scanning Module ........................................................................................................ 12
2.5.4 Reagent Shaking Module ............................................................................................................. 12
2.5.5 New Cards for pipette................................................................................................................... 12
2.5.6 Incubator....................................................................................................................................... 13
2.5.7 Centrifuge module ........................................................................................................................ 14
2.5.8 Reader .......................................................................................................................................... 15
2.5.9 Weight Module ............................................................................................................................. 15
CHAPTER III INSTRUMENT INSTALLATION.............................................................. 16
3.1 AUTOMATIC BLOOD GROUPING SYSTEM INSTRUMENT ACCESSORIES ....................... 16
3.2 INSTALLATION REQUIREMENTS ............................................... 16
3.2.1 Environmental Conditions ............................................................................................................ 16
3.2.2 Power............................................................................................................................................ 17
3.2.3 Computer ...................................................................................................................................... 19
3.2.4 Anti-virus software ....................................................................................................................... 19
3.3 CONNECTED TO INSTRUMENT................................................. 19
3.3.1 Power Connection ........................................................................................................................ 19
3.3.2 Interface of Devices and Computers ............................................................................................ 20
3.3.3 Liquid Line Connection................................................................................................................ 22
CHAPTER Ⅳ OPERATION GUIDE ................................................................................ 23

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AUTOMATIC BLOOD GROUPING SYSTEM USER MANUAL

4.1 CHECK AND ADJUST BEFORE USE ............................................. 23


4.2 POWER ON ............................................................ 23
4.3 ENTER USER SOFTWARE ................................................... 23
4.4 READY TO RUN TEST ..................................................... 24
4.4.1 Loading Reagents and Scan Barcode ........................................................................................... 25
4.4.2 Loading Gel Card ......................................................................................................................... 27
4.4.3 Add Specimens and Test Project .................................................................................................. 28
4.5 RUNNING TEST ......................................................... 32
4.6 SUSPEND OR TERMINATE TEST ............................................... 33
4.7 EXIT PROGRAM ......................................................... 33
4.8 POWER OFF ............................................................ 33
CHAPTER V MAINTENANCE ........................................................................................... 34
5.1 MAINTENANCE METHODS .................................................... 34
5.1.1 Daily Maintenance Methods and Procedures ............................................................................... 34
5.1.2 Weekly Maintenance Methods and Procedures ............................................................................ 35
5.1.3 Regular Annual Maintenance ....................................................................................................... 35
5.1.4 Maintenance Record Form ........................................................................................................... 36
CHAPTER VI TRANSPORTATION AND PRESERVATION .......................................... 42
6.1 PRESERVATION OF INSTRUMENT .............................................. 42
6.2 REMOVE INSTRUMENT ..................................................... 42
6.3 INSTRUMENT PLACEMENT ................................................... 43
6.4 PACKAGING ............................................................ 43
6.4.1 Cleaning ....................................................................................................................................... 44
6.4.2 Packaging pipetting arm ............................................................................................................... 44
6.4.3 Packaging work cabin platform .................................................................................................... 44
6.4.4 Packaging equipment ................................................................................................................... 44
6.4.5 Packaging accessories .................................................................................................................. 45
6.5 TRANSPORT ............................................................ 45
CHAPTER VII TECHNICAL PARAMETERS .................................................................. 46
7.1 EQUIPMENT SIZE AND WEIGHT ............................................... 46
7.2 OPERATING AND STORAGE ENVIRONMENT ........................................ 46
7.3 MODULE PARAMETERS ..................................................... 46
7.3.1 Liquid Handling System Precision ............................................................................................... 46
7.3.2 Pipetting Speed............................................................................................................................. 46
7.3.3 Handler Parameters ...................................................................................................................... 46
7.3.4 Incubate Bit Parameters................................................................................................................ 47
7.3.5 Barcode Scanning Speed .............................................................................................................. 47
7.3.6 Puncture System Parameters ........................................................................................................ 47
7.3.7 Centrifuge Parameters .................................................................................................................. 47
7.3.8 Reader Parameters ........................................................................................................................ 47
CHAPTER VIII ABOUT ....................................................................................................... 48
8.1 USER FEEDBACK ........................................................ 48
8.2 CONTACTS ............................................................. 48
8.3 QUALIFICATION ......................................................... 48
APPENDIX I HISTORICAL RESULTS AND VIEW LOGS ............................................ 49
1.1 HISTORICAL RESULTS .................................................... 49

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AUTOMATIC BLOOD GROUPING SYSTEM USER MANUAL

1.2 LOG VIEW ............................................................ 51


APPENDIX II INSTRUMENT OPERATION AND MAINTENANCE WASH .............. 52
1.1 MACHINE INITIALIZATION ................................................. 52
1.2 DRAWER OPERATION ...................................................... 52
1.3 RINSE MAINTENANCE ..................................................... 52
1.4 PLATFORM DEBUGGER ................................................ 53
APPENDIX III SYSTEM PARAMETERS ......................................................................... 54
1.1 LIQUID PARAMETERS EDITING ............................................... 54
1.2 EXPERIMENTAL PROJECTS EDITING............................................ 55
1.2.1 Micro Gel Immunoassay Definition ............................................................................................. 56
1.2.2 Blood Dispensing Parameters ...................................................................................................... 56
1.2.3 Serum Dispensing Parameters ...................................................................................................... 57
1.2.4 Reagents Dispensing Parameters .................................................................................................. 57
1.2.5 Incubation Parameters .................................................................................................................. 57
1.2.6 Centrifugal Parameters ................................................................................................................. 58
1.3 REAGENT INFORMATION EDIT................................................ 58
1.4 SYSTEM PARAMETER SETTING................................................ 59
1.4.1 “Setting” Main Interface .............................................................................................................. 59
1.4.2 Prompt Option .............................................................................................................................. 60
1.4.3 Centrifuge and Incubator Parameter Setting ................................................................................ 60
APPENDIX 4 ERRORS AND PROMPT ............................................................................. 61
1.1 MOTOR INITIALIZATION ERROR .............................................. 61
1.2 LIQUID LEVEL DETECTION PROMPT ........................................... 62
1.3 BIG GRIPPER CATCHING CARD FAILURE ........................................ 63
1.4 CENTRIFUGE IMBALANCE ERROR .............................................. 64

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AUTOMATIC BLOOD GROUPING SYSTEM USER MANUAL

ChapterⅠOverview

Before performing any work on or with Automatic Blood Grouping System, first read the manual
carefully.
This Section includes the safety precautions about operating on Automatic Blood Grouping System 's.
In this manual, it will in detail talk about the safe specific operation. In the process of reading this manual,
reader have to pay attention to the warning sign labeled content, and must strictly comply with all the safety
instructions of this manual.
Before performing any work on or with Automatic Blood Grouping System, please read the following
safety tips and guidance, well understand and implement all the precautionary measures, to ensure the
proper use of this system, so that user can play its best features, and ensure operator safety.

1.1 Terminology
In this manual:
“Instrument”indicates Automatic Blood Grouping System.
“User Software”indicates the operating software of Automatic Blood Grouping System.
“Data base”indicates all information of user software and testing results of Automatic Blood Grouping
System.

1.2 Safety Regulation


This section describes how to ensure the safety of laboratory personnel and equipment. All precautionary
measures are aimed at ensuring the safe operation on Automatic Blood Grouping System. The operator
must not only entirely operate based on the guidance of this manual, but also comply with local laws and
regulations.
When using Automatic Blood Grouping System, user must strictly follow the instructions for before and
after maintenance work. If not, this system may doesn’t work normally, which may cause incorrect results.
It will cause damage or lost if someone untrained operate on this system, other software or system is loaded
on the computer of Automatic Blood Grouping System, or user do not follow the instructions. AiKang
does not assume any responsibility.

1.3 Symbols
There are Signs and symbols following of Automatic Blood Grouping System in this manual and
packaging. Their meanings are as follows:

Warning: General Warning, please refers to the detailed instructions on the manual, and
carefully operates.

Warning: when operating Automatic Blood Grouping System, there is squeezed,


stabbed risk of injury. Please refers to the detailed instructions on the manual, and
carefully operate.

Warning: There is an electric shock hazard; there is a risk of causing injury or damage to
the equipment. Please refers to the detailed instructions on the manual, and carefully
operate.
Warning: There is a high temperature burn hazards. Please refers to the detailed

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AUTOMATIC BLOOD GROUPING SYSTEM USER MANUAL

instructions on the manual, and carefully operate.

Warning: danger of toxic chemicals may cause operator injury or equipment damage.
Please refers to the detailed instructions on the manual, and carefully operate.

Warning: There are biologically harmful substances, which may cause operator injury or
equipment damage. Please refers to the detailed instructions on the manual, and carefully
operate.

Warning: There is a laser shot, it may cause damage to the operators’ eyes, please do not
look directly into the light emitted from the laser scanning head.

Caution: In the absence of a well understanding of this manual, it will cause damage or
data loss to this system; it is strongly recommended that the operator need to read the
relevant sections of this manual.

Note: Important information to Automatic Blood Grouping System and operating


instructions, please read carefully.

Temperature limits: Temperature Limit that transport package should comply with.

Fragile: Transport package contents fragile, handle with care when transporting.

Upright: Correct positions for transport packages are upright.

Keep dry: keep package dry.

Stacking Limit: The maximum stacking layers of the same package, 4 is the number of
limit.

IVD Vitro diagnostic device.

1.4 System Base Application


The instrument is an in vitro diagnostic medical device (IVD).
Automatic Blood Grouping System is instrument that controlled by computer, can automatically
complete technical operations of immunohematology gel tablets.

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Automatic Blood Grouping System is applicable to all hospitals, blood banks, the CDC and any other
institutions, that need automatic detection of positive and negative stereotypes ABO blood group,
cross-matching of blood, Rh (-D) and irregular antibody screening.

1.5 Purpose and Limitations


The purpose of the instrument is to automatically complete all experimental steps of immune Hematology.
 It can increase safety during the experiment via reducing possible errors of sample identification and
transmission.

 It can effectively improve the efficiency of the experiment via automated batch processing .
 All steps are performed by standardized to reduce the possibility of error handling or subjective bias
error when analyzing, increase the credibility
 It can reduce the risk of the operator being infected via reducing the operator exposure to the sample
and reagents.
Limitations of this device are:
 The instrument can only be used for immunohematology testing, but not for other nominal test
species.
 The instrument can only use cards with gel pores
 If there are doubted or uneven reactions, the operator need to acknowledge.

1.6 Safety Warning and Precaution


Incorrect operation on Automatic Blood Grouping System may cause various forms of mechanical,
electrical, thermal, chemical, and biological damage.
Strictly follow the manual, it can help operator to avoid injury or equipment damage.

Note:Please read carefully the following safety precautions before operation.

1.6.1 Ordinary Precaution


When using Automatic Blood Grouping System, please strictly abide by laboratory operation
specification; wear protective clothing, gloves and glasses. Wash your hands every time after the
experiment is completed, in order to avoid infection.
In the course of instrument running, please do not put any parts of your body stretching into
instrumentation cabin.
No smoking or take foods in the vicinity of the instrument.
During operation, avoid direct glare.
When loading micro gel card, please make sure the gel card does not have any micro debris attached (in
addition to the bar code).
Ensure the uniqueness of each micro-column gel card barcode.
Barcode label to ensure the correct position on the micro-column gel card.
1.6.2 Check and Confirm
Under normal operating conditions, the micro-column gel card can only be loaded through a new niche.
Only in exceptional circumstances that software allows, the micro-column gel card can be directly loaded
into the instrument.
After micro-column gel card loading, please do not move or exchange micro-column gel card.

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Only consumables or original parts supplied by Aikang can match with Automatic Blood Grouping
System, such as dilution plate, waste container, the system fluid bottles etc.
In the course of handling a single module or move the whole instrument, please make sure stable, do not
roll or inverted, and take the necessary protective measures.
To ensure the security and measurement data integrity during operation, please make Uninterruptible
Power Supply (UPS) available.
1.6.3 Security of Electricity
The instrument is grounded through the ground power line, in order to avoid electric shock, the power
ground wire must be grounded.
AC power must be stable; it is prohibited to share power with other high-power instruments.
During operation or maintenance, please don’t touch the power connector on the rear of the instrument pod,
or it may have a risk of electric shock.
1.6.4 Risk Factors

Warning:
Warning: Biological Movement parts
Harmfulness (pipetting channel) (Robot Arm)

Warning: Biological
Harmfulness Power Switch
(Working Platform)

Scram Button
Fig.1.1 Warning flag
1.6.5 Mechanical Hazard
Automatic Blood Grouping System is automation equipment, it may cause personal injury when moving
parts are on work.
Please note the following possible mechanical hazards:
 Robot arm may cause squeeze harm.
 Permanent pipetting needle may cause stabbing harm.
When Automatic Blood Grouping System is in work process, it is strictly prohibited to stretch any part of
body into the working cabin, unless the system has been suspended and a dialog box reminding manual
operation. If not, it may cause injury to the operator, and also Automatic Blood Grouping System
damage.

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1.6.6 Electric Risk


Operator must always comply with electrical safety specifications. Only professional personnel
can carry out electrical repairs.
Please wear anti-static wrist strap or gloves, to protect sensitive components from electrostatic
damage.
1.6.7 Chemical and Biological Hazards
There is a risk of harm to the operator during liquid processing.
 All liquids and solids within laboratory are considered biohazardous, the user must take
the laboratory universal precautions
 All clinical samples are considered possible infection。
 Toxic, corrosive chemicals or radioactive substances must be special handled.
 All treatment, closeness or emissions to dangerous biological and chemicals within
laboratories shall comply with the relevant local laws and regulations.

Note:Please pay attention to warning labels, and follow safety guidelines from reagent
vendors. Laboratory chemical effects and ultraviolet radiation etc. of environmental factors
may cause centrifuges, reader damage. In order to ensure the continued use of the instrument,
please operate strictly in accordance with Laboratory Practices specification.

1.6.8 Software Precautions


When installing the software, please use the original installation CD that provided by AiKang.
It is prohibited to change the date and time of the host when software startup or during operation.
It is prohibited to run any other applications when the user software is running.
It is prohibited to open, edit or delete the test procedure during instrument operation.
Antivirus software may disrupt the user database, for installing anti-virus software, please contact the
engineer.

1.6.9 Manufacturer

Aikang Medtech Co., Ltd.


1,3-5 F, Building B, Zhangkeng Ind. Park, Minkang Road, Minzhi, Bao’an District, Shenzhen,
Guangdong, China
Tel:+86 755 25871250
Fax:+86 755 25871281
Web: www.aikang-medical.com
1.6.10 CE Conformity
Automatic Blood Grouping System is designed to be in compliance with the requirements of the Directive

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98/79/EC on in vitro diagnostic medical devices. With the declaration of conformity the manufacturer
declares conformity with the provisions of the Directive.

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ChapterⅡ Instrument Intended Use and Overview

Automatic Blood Grouping System sets liquid distribution, incubation, reagent mixing, puncture,
centrifugation, analysis and other functions, that required in analysis experiments, in one interpretation,
with intelligent process optimization, to ensure the accuracy of the test results. It is intended to use for
Reverse& Forward tests, Cross Match tests and Antibody screen tests based on Gel cards before Blood
transfusion in Diagnostics laboratories.

2.1 Basic Function


Figure 2.1 shows the platform structure of the instrument:

Centrifuge Balancing Position

Wash Station

Reader
Liss Liquid

Tubes Rack

Reagents Rack Incubation


Mixing Dilution Plate new cards position

Fig.2. 1 Platform Structure of Automatic Blood Grouping System

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Fig.2.2 Physical Platform Structure of Automatic Blood Grouping System

It can automatically perform the whole process of Gel card Blood grouping tests on Automatic Blood
Grouping System, also separately as required pipetting, incubation, centrifugation, reading and other
activities.
Automatic Blood Grouping System main features include:
 Sample barcode scanning
 Sample distributing
 Reagent distributing
 Incubation
 Centrifugation
 Reading
User software controls all modules’ movement, processing test results, test methods setting, and instrument
maintenance. Its Key features include:
 controlling instrument operation
 statistical test results
 generating test results
 creating, editing, test methods
 Instrument System Maintenance

2.2 Basic Configuration


2.2.1 Module Configuration
Automatic Blood Grouping System is constituted by 6 main modules:
 Pipetting
 Gripper
 Incubator
 Centrifuge
 Puncture

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 Reader

2.3 Working Process


Automatic Blood Grouping System perform sample and reagent dispensing by pipetting arm, then
incubation, centrifuge, and finally reading. Then user can view results on the computer or print results.

2.4 Automatic Blood Grouping System Configuration


Tube
Robot Pipetting Sample Incubator Centrifuge
Model Rack Reader
Arms Channels Position Position Position
Scanner
Aigel 100 1 1 1 96 24 24 1

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Start switch
Front door
handle

Light switch

Scram button
Fig.2.3 External View

Communication port

power input

Fig.2.4 Back View

2.5 System Module


2.5.1 Robot Arm Module

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Fig.2.5 robot arm


Pipetting channel is located at the left side of robot arm, it mainly perform liquid dispensing as per the
program that set by user. During operation, each channel of pipetting arm can flexibly run in X, Y, Z
directions to perform liquid dispensing.
Gripper is located on the right side of robot arm.
Main function of gripper is to transfer gel card from the new card positon to incubator, centrifuge and then
reader. Gripper can move in X, Y, Z directions.

2.5.2 Wash Station


Multifunction washing station is set on the working cabin platform, with multi-washing mode, ensure the
carry-over rate reducing to 10-7 (0.1ppm).

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Fig.2.6 Wash station


2.5.3Tube Rack Scanning Module

Fig.2.7Tube rack scanning module

Tube rack scanning module’s main function is to place the specimen and scan the specimen barcode.
Specimen are placed in a single tube rack, each rack can be placed up to 16 samples. In the beginning of the
experiment, the tube rack is pushed into the tube rack carrier one by one according to prompts; the scanner
will automatically scan the barcodes.

Warning:During scanning, there is laser beam ejecting from the scanner, please don’t stare at
the scanner.

2.5.4 Reagent Shaking Module

Fig.2.8 Reagent shaking module

Reagent bottle will be placed on this shaking module to mix reagent. When pipetting is not performing, this
module will shake to mix reagents; when performing, it will stop shaking and return back to balance to
ensure well pipetting.
2.5.5 New Cards for pipette
Before running test,please Tear the aluminum film on the gel card After starting test, the gripper will get
the new card to scan, and then place on the original position. Start pipetting……

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Fig.2.9New Cards for pipette

2.5.6 Incubator

Fig.2.10 Incubator

After liquid dispensing, the gel card will be incubating. Incubating temperature and time can be set via user
software according to the reagent specification.
This incubator can place up to 24 gel cards at the same time. If some cards need incubation ,the gripper will
holding a gel card gets to the incubator, Then close the lid began to incubation.

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2.5.7 Centrifuge module

Fig.2.11 Centrifuge

The main function of this module is to centrifuge the gel card, in order to deposit the un- agglutination red
blood cells in the bottom of gel card.
This module can hold up to 24 gel cards to centrifuge.
When centrifuging, gel card tray must be trimmed. User software can calculate based on the number of test
sample, and grip the new card to make it balance.

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2.5.8 Reader

Fig.2.12 reader

The reader of Automatic Blood Grouping System, is researched and developed by Aikang, with high
reading speed, high reliability.
Reader is to read reacting card and transport the results and the original image to the system database.
2.5.9 Weight Module

Fig.2.13 System liquid module


Weight module was optional for user.The weight module is for monitor system liquid, maintenance liquid
and waste liquid volume. Three independent weight sensors measure weight of three bottles and transfer
date to across system in real-time. When there is insufficient amount of liquid, a warning message is
displayed.

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Chapter III instrument installation

The instrument must be installed by a professional technician


Operator before operating the equipment required to through professional operate training, and access to
training certificates.
When the user receives the instrument must be checked to determine within the package includes all the
components that the attached list specified models.
In the process of opening the package is subject to section 6.2, "Removing the instrument" for instructions.
In the course of the placement of the instrument is subject to Section 6.3 "instrument placed" in the
description.

3.1 Automatic Blood Grouping System Instrument Accessories


Before installing Automatic Blood Grouping System must ensure that the following materials have
arriving random device:
1) Packing List
2) Instructions
3) Warranty Card
4) Certificate

3.2 Installation Requirements


Equipment installation site requirements are as follows:
 Environmental Conditions:See section 7.2 "Operating and storage environment."
 Space Requirements:The instrument will take a 110cm (L) × 80cm (W) × 110cm (H) space.
 Do not place the device on a flat surface that made of flammable material.
 Do not place the instrument in place where is not easy to repair.
 Do not place in the place that the instrument is not easy to disconnect the main power supply.
 Do not place the instrument or flexible cables come into contact with hot surfaces that can not touch.
 Check whether the plug is grounding.
 Check whether the power supply voltage is consistent with identifies supply voltage of the instrument.
 Do not place anything on top of the instrument.
3.2.1 Environmental Conditions
The Automatic Blood Grouping System only suitable for indoor operation and indoor storage. The
following table lists the environmental parameters requirement that suitable SYSTEM operating and
storage.

Parameter Operating Environment Storage Environment


Temperature 15~32℃ -20~55℃
Relative Humidity 30~80℅Non-condensing ≤93℅Non-condensing
Pollution Index 2 -
Voltage Category ‖ -
Table 3.1The Operating Environment and Storage Environment for the Automatic Blood Grouping System
The venue place the Automatic Blood Grouping System must have sufficient stability, by order of the weight
must be greater than twice the weight of the instrument, and satisfy the space required for installation.

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Automatic Blood Grouping System size and weight:

Dimensions Weight
Model
Length × width × height(mm) (kg)
Aigel 100 1038×781×1039 145
Table 3.2 Instrument Dimensions and weight

Depending on the configuration of the instrument,working audience should be set aside area to place
auxiliary equipment.
Placement of the instrument must ensure that the operator can easily operate and maintain the instrument,
and ensure good ventilation.
Besides,Automatic Blood Grouping System installation location must also meet:
The plant operator can hear the alarm device, can see the indicator signal. When the device occurs an
exception in need of emergency stop, the operator can easily press the red emergency stop button in the left
corner of the front of the device, so that disconnect the power supply of all modules of the equipment in a
timely manner.

Notice:
In the dry environment, especially the existence of artificial materials (synthetic fabrics,
carpet, etc.) ,when using this equipment, may cause damage of electrostatic discharge, resulting
in abnormal operation.
Beside the strong radiation sources shall be forbidden to use the device, otherwise it may
interfere with the normal work of the equipment.
evaluate the electromagnetic environment before Install the equipment.

3.2.2 Power
Automatic Blood Grouping System suitable for 220V AC power,the power supply requirements are as
follows:
Power outlet should not be located at the back of the instrument, ,Shall be placed in a position that
convenient operation,current supply of the equipment should be implemented voltage control, and make
overload protection.
Automatic Blood Grouping System power as show in the following table:
Model Power Fuse Specifications

Aigel 100 350VA F6.3AL250V


Table 3.3 the Power of the Automatic Blood Grouping System
In order to ensure the safety operation, the Fuse will cut off the circuit in current abnormally
elevated to a certain height and heat, so as to protect the safe operation of the circuit.Fuse is
installed in the instrument power input port, if the fuse is damaged, please contact a professional
for replacement.

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Fig.3. 1fuse

Fig.3. 2fuse replacement

Note:The operator is not allowed to contact or replace with the fuse, If you need to replace the
fuse, to be operating by professionals.
Warning:There is high-voltage in the interface main power box of the instrument. When the
repair or maintenance of equipment, please cut off the power first.

Aikang MedTech Co.,Ltd recommends that you use UPS (3KVA) power. When experimental power
outage occurs, the machine can continue to run,to ensure experimental data and experimental processes
information is not lost, the equipment potential damage caused by power outage when running can also be
prevented.
UPS power specifications:
Technical Details Recommended values
Maximum power
3000W
consumption
Average power consumption 500-650W
Average power consumption
~300W
of the computer

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UPS output 750-2500W


UPS average output 100-240VAC
Capacity 1-2KVA
Backup time 8-15min
Input Voltage 110VAC and 220VAC
Cycle Single-cycle
Table 3.4UPS power supply specifications grounding requirements

In order to ensure safe operation of laboratory personnel,Aikang MedTech Co.,Ltd requires the equipment
grounding. Automatic Blood Grouping System is grounded through the power line ground. To avoid
electrical shock, the power supply must be connected to earth ground.
3.2.3 Computer
Install and run Automatic Blood Grouping System requires a separate computer (computer), Please do
not share your computer with other devices or systems.
Automatic Blood Grouping System equipped with a computer, fully able to meet the instrument software
to install, use requirements. For a self-made computer, the computer's configuration requirements of not
less than:
Configuration Name Parameter
CPU 2.4GHz
Memory 1GB
Monitor Color, Resolution:1280×1024
Operating system Windows XP/7, RecommendWindows7
Serial ports:RS 232
Board Connector USB:4×USB2.0
Computer I slot:2×computer I Express
Table 3.5 Computer minimum

3.2.4 Anti-virus software


When Symantec and other antivirus software working, section of the configuration file of the equipment
may be deleted or destroyed as suspicious files. It may also damage the user's software database. When the
instrument is running,Virus may slow down or even suspend the operation of the user software.
If you need to install anti-virus software to protect your computer, please contact our service engineer to
installation and setup; do not attempt to install anti-virus software on your computer.

3.3 Connected to Instrument


3.3.1 Power Connection
One of the ends of the power line to connect the power input port on the equipment, the other end connects
the power output port.

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Fig. 3.1Instrument power access port

3.3.2 Interface of Devices and Computers


The Automatic Blood Grouping System instrument has two CAN bus, follow the signs that upper end of
the port to the make corresponding connection. Side near the computer's motherboard is CAN1 bus
connection port.

Fig. 3.2Bus connection device interface

Follow the signs, use USB cable to connect the instrument to the computer corresponding port.

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Fig. 3.3Instrument video output line interface

video output line access to


the PC USB port,No order
of connection

CAN1,CAN2 Bus,
Close to the motherboard
side is CAN1

Fig. 3.4 Instrument bus, video output lines connect computer interface

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Fig. 3.5 Instrument connections

3.3.3 Liquid Line Connection


In accordance with the piping logo to connect system liquid pot, maintenance liquid pot, waste liquid pot
and equipment respectively by annex pipeline.

Fig. 3.6 The connecting port of system liquid, waste liquid pipe

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Chapter Ⅳ Operation Guide

4.1 Check and Adjust before use


In order to avoid any possible software malfunction, We recommend:
1) In addition to the stringent requirements, please do not install any additional software or hardware.
2) To confirm correct assembly of the Automatic Blood Grouping System, and computers, operating
systems, users software, and CAN card are also Installed.
Make sure the instrument is in proper operating condition according to the following steps:
 Check whether the instrument is connected to the main power supply.
 Check whether the instrument CAN bus, USB data cable is properly connected to the computer
 Check whether the switch is turned on.
 Check whether the system liquid bottle and waste liquid bottle is placed in the correct position and
whether the pipeline is bending block, and whether the waste liquid bottle is empty, whether the system
liquid was properly prepared in the system liquid bottle.
 Check whether there is sufficient dilution plate on dilution plate position.

 Double-click the icon of the Auto Blood software into the software. Click on the device
menu to initialize the machine, to view whether there are error messages or warnings to ensure that the
device is properly connected.
 The system parameters in the system parameters must be checked whether they are set correctly before
use, to ensure that the test is edited correctly.

Note:The software that Aikang provides does not allow non-professionals to make any
changes.

4.2 Power On
Users need to start with the computer equipment in the following order:
1) Press the instrument power switch to turn on the Automatic Blood Grouping System
instrument.
2) Start the computer that controls the Automatic Blood Grouping System instrument.

4.3 Enter User Software

Double-click in the path D:\ Across to open the login screen, as show as Figure 4.1:

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Fig. 4.1Login screen

Login user name is admin, login password is 0001.

4.4 Ready to Run Test


User Switch Functional button
area

Test status display area


Menu bar area

Fig. 4.2 The main interface of run

Reagent submit interface.

Gel card submit interface.

Submit sample and scan barcode interface.

Run the test. The button will be invalid during test running.

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Pause test.

Quit software.

4.4.1 Loading Reagents and Scan Barcode

In operation interface, click to enter the reagent loading interface, as show as Figure 4.3:

Fig. 4.3 Reagent loading interface

Put the corresponding reagent bottle into the reagent carrier, click , the scan head lamp lights,
then slowly push the reagent carrier to the end position. This time reagent bottle barcode scanning results
will be displayed in the list shown in Figure 4.3. Reagent scan module was optional for user.
If you need to manually enter the barcode,manually enter the barcode corresponding to the reagent bottle

in the input box, entered the position number that reagent bottles are

placed on the rack in the input box, click to loading barcode.


The reagent bottle barcode that manually input shall comply with reagent barcode rules that set in reagent
information edit in Appendix III. Barcodes that comply with the barcode rule can determined the type of
the reagent that loaded.

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Fig. 4.4LISS liquid loading interface


The barcode scanning of Liss liquid required handheld barcode scanner to scan, the cursor should be

positioned into the box before scanning; scan results are displayed in the input box,
and then placed the Liss liquid bottle into the position of Liss liquid. Enter the position number in the
Position box to specify the location that the Liss liquid is placed.

If you need to manually enter the barcode, just enter the barcode in , enter the position
number in the Position box to specify the location that the Liss liquid is placed.

Finally, click to loading bar, click to Confirm and exit.


The Liss liquid bottle barcode that manually input shall comply with reagent barcode rules that set in
reagent information edit in Appendix III. Barcodes that comply with the barcode rule can determined the
type of the reagent that loaded.

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4.4.2 Loading Gel Card

In operation interface, click to enter micro gel card loading interface, as show as Figure 4.5:

Fig. 4.5 Micro gel card loading interface


Click “Open” to open drawer, load card boxes included with gel cards into drawer plate and push drawer
back into instrument manually. Device will take and scan type of those cards and present information in
interface.
User also could submit and load cards as this way:

Enter the code in , enter the position number of the micro-gel cartridge is

placed in the drawer in , click to loading, click to confirm


and exit.
The micro gel card barcode that input manually shall comply with micro gel card barcode rules that set in
micro gel card definition in Appendix III. Barcodes that comply with the barcode rule can determined the
type of the micro gel card that loaded.

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4.4.3 Add Specimens and Test Project

In operation interface, click to enter the test project and the sample count loading
interface, as show as Figure 4.6:

Fig. 4.6 Loaded specimen interface

4.4.3.1 Scan Sample Barcode


Enter into sample loading interface, slide in sample rack into rack holder to scan barcode.

Scanned barcode will be displayed in interface automatically.

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Once there is one barcode un-scanned, please slide out corresponding sample rack, check
the integrity of sample barcode and re-scan that rack.
If there are still some barcodes not scanned perfectly, user could double click corresponding
wells and type in barcode manually.

Attention: 1. All sample barcodes direction should be same with location barcode
direction.
2. Pause a little bit at the edge of sample rack holder when sliding samples
in to trigger the laser scanner to light up, then slide the tube rack in
smoothly.
3. Please scan the sample as a uniform speed.
Warning: There is laser ejected from scanner, please do not stare at lens.

4.4.3.2 Input Barcode Manually


User could edit sample barcode in sample barcode interface.
Double click the well to switch to editing mode, input sample barcode from keyboard and

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click “Next” in interface.


For sequential barcodes which have progressive increment law or diminishing law, user can

input initial position in , input sample count in , starting

number in and barcode prefix in . Click

to create the sample barcode.

Fig 4.8 Input sample barcode manually

If urgent sample is needed, tick the frame. .

Warning:
1. For correct operation, sample barcode must be stick on sample tube and it’s not
manuscript or missed.
2. Using haemolytic, chylus, clotted or visible fibrous protein may lead to false
positive result.

Note: Please use samples after centrifugation.

4.4.3.3 Choose Assay Item


After sample scanning, click next to choose item, the horizontal row contents are test items,
the vertical column contents are sample barcode, maximum barcodes number of one column is
16, if samples are more than 16, click left and right arrows to switch different columns among A

to F column.
One sample could be selected to do multiple items, as show as figure 4.9. All selected test
item must be edited before test running. For item editing, please take the contents in appendix 3
as reference.

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When “Complete Cross Match Major & Auto” is chosen, click to use patient cursor
for selecting patient, left click in blank area in list according to sample barcode, the “P*” will be

marked after selection. Click to use donor cursor for selecting donor, left click in blank
area in list according to sample barcode, the “D*” will be marked after selection. One patient

could be matched with several donors synchronously in cross match item. Click to

select second patient, this frame will become cross 2 which means
second patient, then select corresponding sample as shown above.
If other item (not cross match) such as “Forward&Reverse ABO with DVI-/DVI+” is
selected, tick the corresponding position directly. Multiple options could be selected by
dragging mouse.

If any mistake happened, use to cancel selected sample. Left click the

icon and then left click the samples need to be deleted.

If LIS is connected, use import function to import sample and item


information. Across software will import data automatically to “D:\Across\ Data\Servers.dat”.

After all sample selected, click to submit the test.

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Figure 4.9 Select items

Warning:
For proper operation of the instrument, barcode must be firmly affixed in the sample tube wall
and cannot be handwritten or missing.
Use Hemolytic, chyle samples or with clot, visible fibrins samples may lead to interpretation of
false-positive results occur.
Note:Experiments should be used the centrifuged sample.

4.5 Running Test

Close the device front door, click to run the current test.

Note:Before the test run the front door of the equipment should be closed.

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4.6 Suspend or Terminate Test

Click then pause screen appears and suspend the current test. Click“continue”button to
continue running test.

Fig. 4.7 Pause Interface

Check the "Enable Abort button" and click on the "Abort" button to terminate the current test.

4.7 Exit Program

Click to exit the test program. It cannot exit when the process test is running, you
can exit after terminate the test.

4.8 Power Off


When test run is completed, turn off the instrument and the computer in the following order:
1) Turn off the computer that control the Automatic Blood Grouping System instrument
2) Pressed the power switch bottom right of the Automatic Blood Grouping System instrument to turn
off the instrument power.
3) Press the button of the light switch to turn off the instrument lights.
4) Turn off the main power supply.

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Chapter V Maintenance

In order to ensure the accuracy and reliability Automatic Blood Grouping System running experiment,
the user must be a regular maintenance and repair for the instrument.
Automatic Blood Grouping System equipment maintenance is divided into three different levels:
 Daily maintenance
 Weekly Maintenance
 Regular annual maintenance

Warning:To safely perform maintenance work, please wear a lab coat, wear disposable rubber
gloves and protective glasses.

5.1 Maintenance Methods


5.1.1 Daily Maintenance Methods and Procedures
Daily maintenance is divided into maintenance before the experiment and maintenance after the end of the
experiment two parts.
5.1.1.1 Maintenance before Test
1) Check the waste liquid bucket and system liquid bucket
Please check whether the waste liquid in waste liquid bucket has been emptied before the experiment. If
there is no empty, keep the waste liquid into the designated location and make the necessary disinfection.
Check whether the system liquid in the system liquid bucket is adequate.
2) Check the outer wall of the tip
Check whether the outer wall of the tip is clean. If there are stains or other attachments, with a lint-free
paper which moistened with alcohol to gently wipe, and then with a lint-free paper dipped in distilled water
to clean.
3) Check the wash station
Check whether the wash station is clean. With a cotton swab dipped in alcohol to wipe the inside wall of
the wash station, then washed it with dilute molar lotion. Finally, use distilled water rinsing.
4) Initialize System

Turn on the instrument power and open user software, click to initialize the system.
Observe whether each pipetting channel operation is normal during the initialization process. If there are air
bubbles in the pipeline,Please re-initialize the system and flick pipeline with your hand until bubbles
cleared during rinsing.
If the bubbles in the pipeline cannot be excluded, to check the interface in the pipeline whether there is
leakage, etc. and phone contact engineers to solve problems.
5.1.1.2 Maintenance after Test
1) Clean the tip

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After closing the instrument, with a lint-free paper or swabs moistened with alcohol to gently wipe the
outer wall of the tip to remove a blood clot or reagents crystallization may exist.
2) Clean the wash station
With a cotton swab dipped in alcohol to wipe the inside wall of the wash station, then washed it with dilute
molar lotion and other special lotion. Finally, use distilled water rinsing.
3) Empty waste liquid bucket
Keep the waste liquid into the designated location and make the necessary disinfection.

Warning:
Waste liquid container and pipeline with biohazardous, please take precautions : Wear
protective clothing; wear protective rubber gloves and protective glasses.
After maintenance is completed, please wash your hands with disinfectant to prevent microbial
infection.

4) Cleaning Platform
Remove the test tube rack, reagent bottles and other accessories from the work cabin platform of the
instrument. Use a wet cloth with distilled water to carefully clean the surface of work cabin platform and
each module, and then wipe them with 75% alcohol solution.
If the reagent or other liquid residue on the platform, please scrubbed with cotton dipped in alcohol. Finally,
wipe it with alcohol.
Used dedicated scanning head wipes to clean the lens of the specimen scanning head, ensure that the mirror
clean and dust-free.
5.1.2 Weekly Maintenance Methods and Procedures
1) Cleaning system liquid bucket
After the experiment is completed, empty the system liquid in the system liquid bucket. Use of distilled
water that is not higher than 50 ℃, Cleaned it with a brush Then washed three times with distilled water.
2) Soak pipeline
According to the proportion to formulate Moore lotion and loaded into the system liquid bucket. Click the
"rinse needles" under the "action" menu bar in the user software to rinse the pipetting channel three times,
each time let Moore lotion soaking in the pipeline 15 minutes.
Finally, rinse pipeline 3 times with system liquid.
3) Backup Auto Blood Folder
Exit Auto Blood user software,compressed backup Auto Blood folder which is under "D: \".
4) Check the condition of tip
After closing the instrument, check whether there is an obvious scratch on the tip of liquid handling system.
If the tip coated layer is damaged, please contact engineers to replace tip.
5) Wash all reagent bottles, dilution plates
Empty all reagent bottles, dilution plates(Excluding the single-use bottle or dilution plate), Wash them
with distilled water, and then dry naturally.
5.1.3 Regular Annual Maintenance
Regular annual maintenance performed by the engineers of Aikang MedTech Co.,Ltd or authorized agent
engineer, perform precision calibration of the instrument and thorough cleaning and maintenance.

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 Engineer to check the user's situation of daily maintenance and weekly maintenance. If find that user
did not perform a complete maintenance cycle, it is need to retraining instrument operator and stressed the
importance of the maintaining.
 Asks the user the existing problems in used, record and solve them.
 Check and clean the system solution bucket. First use water that is not higher than 50 ℃to clean, then
disinfected with disinfectant(or 75% ethanol),after soaking for 15 minutes, washed with distilled water.
 Check whether the operation of each module of pipetting arm and handler are normal. Check whether
the screws are loose or rusty; clean the two robotic arms rail. Prohibited use alcohol or other solvents to
clean the rails.
 Check whether there are damages of washable tip, etc.,and regulate verticality of the tip.
 Check whether the centrifuge tray rotor is flexible and do necessary cleaning lubricated.
 Clean-up the sample pump. Filled with system solution to the system solution bucket. Enter Auto
Blood user software to rinse tip, emptying all air bubbles in the pipe.
 Test whether probe module function of each tip is normal.
 Calibration accuracy of the liquid handling system.
 Calibration accuracy of the reader.
 Clean the entire platform of the equipment and its surface.
 Back up all motors and pumps hardware parameters and hardware version information.
 Check the Ghost of the system whether exist. If not, redo system Backup.
 After the instrument maintenance engineer need to fill < Regular Annual Maintenance Record Form >
carefully.
5.1.4 Maintenance Record Form

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Daily Maintenance Record Form(Ⅰ)


Modification date:
Please tick √ in the related maintenance projects and signed after complete maintenance.
Maintenance items and Anomalies
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
methods recorded

Check whether the system liquid


bucket and waste liquid bucket are
empty before the experiment

Check whether the outer wall of the


tip is clean before the experiment
Check whether the wash station is
clean before the experiment
Initialize system before the
experiment
Clean the reader after the
experiment
System maintenance after the
experiment

Clean the tip after the experiment

Clean the wash station after the


experiment
Empty the waste liquid bucket after
the experiment
Clean the platform after the
experiment

Maintenance
personnel Signature
Please carefully complete the periodic maintenance procedures specified in this table, and complete maintenance records. If you find equipment malfunction, please
immediately contact service engineer that Aikang authorized. Telephone service: 800 999 0929.

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Daily Maintenance Record Form(Ⅱ)


Modification date:
Please tick √ in the related maintenance projects and signed after complete maintenance.
Maintenance items and Anomalies
16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
methods recorded
Maintenance items and
methods
Check whether the system
liquid bucket and waste liquid
bucket are empty before the
experiment
Check whether the outer wall
of the tip is clean before the
experiment
Initialize system before the
experiment
Clean the glass of the reader
after the experiment
System maintenance after the
experiment
Clean the tip after the
experiment
Clean the wash station after
the experiment
Empty the waste liquid bucket
after the experiment
Clean the platform after the
experiment
Maintenance personnel
Signature
Please carefully complete the periodic maintenance procedures specified in this table, and complete maintenance records. If you find equipment malfunction, please
immediately contact service engineer that Aikang authorized. Telephone service: 800 999 0929.

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Weekly Maintenance Record Form


Modification date:
Please tick √ in the related maintenance projects after complete maintenance or make relevant records and please sign after completion.
Maintenance items and Month Month Month Month Month Month Month Month Month Month
methods Day Day Day Day Day Day Day Day Day Day
Lubricated centrifuge
rotor tray
Clean system liquid
bucket and base

Soak pipeline

Backup Auto Blood


directory
Check the tip (Whether
there are apparent rub
scratches)
Lubricating the rails of
drawer tray

Maintenance
personnel
Signature
Please carefully complete the periodic maintenance procedures specified in this table, and complete maintenance records. If you find equipment malfunction, please
immediately contact service engineer that Aikang authorized. Telephone service: 800 999 0929.

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Regular Annual Maintenance Record Form


Modification date:
Please tick √ in the related maintenance projects after complete maintenance or make relevant records and please sign after completion.
Maintenance items and
Completion Remark
methods
Engineer to check the user's
situation of daily maintenance
and weekly maintenance. If
find that user did not perform a
complete maintenance cycle, it
is need to retraining instrument
operator and stressed the
importance of the maintaining
Asks the user the existing
problems in used, record and
solve them

Check and clean system liquid


bucket and its base

Replacement pipeline of
the liquid handling system
Check whether the operation
of each module of pipetting
arm and handler are normal.
Check whether the screws are
loose or rusty, clean the two
robotic arms rail
Check whether there are
damages of washable tip, etc.,
and regulate verticality of the
tip

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Check whether the centrifuge


tray rotor is flexible and do
necessary cleaning lubricated

Check whether the reader is


clean and make the necessary
cleaning

Clean-up the sample pump


Test probe module of each tip
Calibration accuracy of the
liquid handling system
Calibration accuracy of the
reader
Clean the entire platform of the
instrument and its surface
Back up all motors and pumps
hardware parameters and
hardware version information
Backup computer operating
system

Maintenance
personnel Signature

Equipment
Authorized Signature
Please carefully complete the periodic maintenance procedures specified in this table, and complete maintenance records. If you find equipment malfunction, please
immediately contact service engineer that Aikang authorized. Telephone service: 800 999 0929.

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Chapter VI Transportation and Preservation

6.1 Preservation of Instrument


To long-term storage Automatic Blood Grouping System,suggested that it can be packaged in the way of
transport packaging.
Preservation of the environment conditions for equipment was defined in section 7.2 "operating and storage
environment".
The instrument storage space requirement is:170cm(L) ×79cm(W) ×116cm(H)。
Weight:225Kg.

Note:When transporting the instrument, use only the original packing material.

Warning:Before transport, please note that the instrument be cleaned.

6.2 Remove Instrument


When removing the instrument, you need to follow these steps:
 Unscrew the screws that fixing the wooden lid, remove the wooden cover.
 Remove the panel screws around the wooden and then remove the panels around the
wooden.
 Cut fixed tie on the base of the box that used to fix the equipment, dedicated bickering
handle screwed on the base ends of the device.

Warning:
Prohibited crawling robotic arms of the Instrument, glass plate or platform trunk to lift the
equipment.
Note:
Please keep the packaging material after disassembly, so that packaging equipment to the next.

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Fig. 6.1Bickering handle

Fig. 6.2Bickering handle installation


6.3 Instrument Placement
Before Automatic Blood Grouping System packaging does not open, it should be together with shelves
placed from where you want to install it on the floor as close as possible.
 Before moving the instrument, attached the four handles in the box to the four positions in
the bottom of the instrument.
 Keep the instruments upright, while lifting all sides, in order to put Automatic Blood
Grouping System in the required place.
 When lifting equipment needs four or more people collaborative, each person hold a
bickering handle, smoothly lifted the device, placed on the workbench, make the four feet
cup fall in the corresponding anchor point.
 Loosen the table caster lock tight snap, move along the table together with equipment to the
mounting position.
 Remove the PE protective plastic film on equipment acrylic glass.
 With scissors carefully cut PE packaging film on the pipetting arm and platform module
components, remove the foam board. While cutting, please pay close attention to the
equipment line and shell; beware of false cut lines, piping or equipment damage.

Warning:The heavier the weight of the instrument, while handling should pay attention to
safety.

Note:Do not turn on the main power immediately after placement instrument; please operate
according to this manual follow.
When removing the packaging film, to handle with care, it can not scratch.

6.4 Packaging
When packing equipment, we recommend that you use the original foam blocks and boxes. If the original
carton and foam block lost or damaged, please contact your supplier or Aikang MedTech Co.,Ltd to
re-order.

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6.4.1 Cleaning
Before packaging, transportation equipment, instruments should first conduct a comprehensive clean.

Warning: When cleaning, there may be a potentially dangerous liquid spilled from the
instrument process, including infectious clinical sample, biological hazard.
Cleaning and decontamination equipment and modules before transport packaging, please
wear protective clothing, gloves and glasses to prevent infection.

 System liquid pot installed with distilled water, for all pipetting channels and pipeline
flushing operation.
 With a cotton swab dipped in 75% alcohol to clean the ends of each pipetting tip.
 With a cotton swab dipped in 75% alcohol to wipe the inside and outside of grip shrapnel.
 With a cotton swab dipped in 75% alcohol to clean equipment work cabin platform
6.4.2 Packaging pipetting arm
 Together pipetting tip adapters for each pipetting channel, and moved to the middle position
in the Y direction of pipetting arm.
 With thicker foam blocks to protect pipetting tip adapter, and use PE packaging film fixed
on the cover of pipetting arm.
 Move the pipetting arm to the left, close to the left side plate of the instrument work cabin,
and plus foam board apart between the left side plate of work cabin and pipetting arm.
 Below the ends of the Y direction in the pipetting arm plus foam blocks to support,Prevent
pipetting arm sliding along the rails.

Note:Use PE packaging film to fixed pipetting channel together,Z direction should use foam
board fixed to the home position, Otherwise, may cause pipetting channel vertical deformation,
thus affecting the pipetting accuracy.
6.4.3 Packaging work cabin platform
 Remove the test tube rack module, incubate module, kit, dilution plate and carrier,
centrifuge, reader on the work cabin platform, wrapped with foam packaging film to protect,
place into the special box to packaging.
 Covering a thin sheet of foam on the platform, then tightly wrapped with PE packaging film
fasten it to the floor on the table.
6.4.4 Packaging equipment
 Installation the equipment acrylic glass and wrapped with PE packaging film.
 Transport handle fitted to the instrument, lift the equipment,carefully placed on the wooden

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pallet of packing crate, let the structural frame in the bottom of the device fall on the foam
blocks on the wood care of the box.
 Remove the transport handle, packaged devices to save.

Fig. 6.3 Instrument Packing


 Plus foam board around and on the side of the instrument, to ensure that each directions are
protected.
 Installation box side panels and roof.

Fig. 6.4 Instrument Packing


 With screws to tightly fixed the side plates and wooden pallet of the box.
6.4.5 Packaging accessories
The other accessories packing with shockproof foam box and put into the corresponding box.

6.5 Transport
When transporting the instrument, the transportation Precautions on the instrument package must be
meeting. When handling the instrument, it must be placed vertically upwards, prohibit rollover, collision or
fall and to prevent rain.

Note:During transport, even moving short distances, pipetting arm of the instrument must be
fixed in the side panels of the work cabin. Meanwhile, pipetting channel should be placed in
the origin position of Z direction.
Before transport, if you do not take the right package of instruments, the damage caused will
not warranty.

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Chapter VII Technical Parameters

7.1 Equipment Size and Weight


Dimensions 1038mm(L)x781mm(W)x1039mm(H)
Weight 145kg

7.2 Operating and Storage Environment


Parameter Operating Store
Temperature 15-32℃ -20-50℃
Relative Humidity 30~80℅Non-condensing ≤93℅Non-condensing
Pollution Degree 2 --
Overvoltage category ‖ --
Table.7.1 Environmental parameters of instrument
7.3 Module Parameters
7.3.1 Liquid Handling System Precision
Add Sample Repeatability Accuracy
Volume (μl) (CV)% %
10 ≤3.0 ≤±5.0range
50 ≤2.0 ≤±1.0range
100 ≤1.0 ≤±1.0range
Table 7.2 Liquid Handling System parameters
7.3.2 Pipetting Speed
 Using 4 channel distribution of samples and reagents to 24 gel of time≤20min
7.3.3 Handler Parameters
Positioning accuracy ±0.2mm
Grasping quality ≥500g
Stepping Adjustment 0.1mm
Table.7.3 Handler parameters

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7.3.4 Incubate Bit Parameters


Incubation temperature range Room temperature to 60℃
Incubation temperature accuracy ±0.5℃
Incubation time 0~240min adjustable
Adjustment Stepping 0.1℃
Capacity ≤24 Card/batch
Table7.4 Incubate bit parameters
7.3.5 Barcode Scanning Speed
 Sample barcode scanning speed≤70s/96 sample
 Micro gel card barcode scanning speed≤30s/1 Card
7.3.6 Puncture System Parameters
Puncture channel 6 channels or 8 channels optional
Puncture speed >80 Hole/min
Table.7.5 Puncture system parameters
7.3.7 Centrifuge Parameters
Capacity ≤24 Card/batch
Centrifugal Speed 0~2000 Rev/min
Speed relative deviation ≤±2.5%
Table7.6 Reader parameters
7.3.8 Reader Parameters
Imaging principle CCD digital imaging technology
Interpretation speed 24 micro gel cards/8min
Table7.7 Reader parameters

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Chapter VIII About

8.1 User Feedback


Automatic Blood Grouping System is a continuous improvement instrument. We look forward to your
feedback; we will improve the software according to your suggestions. If you have any suggestions or ideas
please:
(1)Visit Aikang MedTech Co.,Ltd web site and leave a message.
(2)Send e-mail to aikang@aikang-medical.com and indicate“Automatic Blood Grouping System
user feedback”in the subject.
We will read every piece of information on user feedback, and appropriate to adopt them, thank you again.

8.2 Contacts
Company Name:Aikang MedTech Co.,Ltd
Registered Address:Building B, Zhangkeng Industrial Park, Minkang Road, Minzhi, Bao’an District,
Shenzhen, Guangdong, China
Production Address:Building B, Zhangkeng Industrial Park, Minkang Road, Minzhi, Bao’an District,
Shenzhen, Guangdong, China
Phone:0755-25871250 Toll-free:800-999-0929
Fax:0755-25871281
Technical Support:Service@aikang-medical.com
Product Sales:Sales@aikang-medical.com

8.3 Qualification
Manufacturing Enterprise License for medical device No.:粤食药监械生产许20030835号
Registration certificate for medical device No.:
Product Standard No.:YZB/粤 2100-2013
Online Website:http://www.aikang-medical.com
Instant Messaging
Phone:0755-25871250 Toll-free:8009990929
Fax:0755-25871281

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Appendix I Historical Results and View Logs

In the historical results interface can view the historical results data and the run log information,as shown
as figure 9.1:

Fig. 9.1 Enter historical results and View logs interface


1.1 Historical Results

Click to go into historical results view interface, can filter the results of history by date or
project, and can,And can printout etc., as shown as figure 9.2:

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Fig. 9.2View historical results

Select one result and double click, the coming window will represent detailed information
and result picture of current sample. User can check patient information, reanalyze, save result,
print result and send result in this page as show as figure 9.3.

Fig. 9.3 Updating patient information

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1.2 Log View

Click to go into the Longview interface; user can open history running log, save the
current log, etc. as below:

Fig. 9.4 Log view

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Appendix II instrument operation and maintenance wash

Select "Device" in the left column to go into the instrument operation and maintenance interface, as shown
below:

Fig. 10.1 Equipment operation and maintenance


1.1 Machine Initialization

Click to initialize the machine.

Note:After the first turn on, it request on this to initialize the machine.

1.2 Drawer Operation

Click can open the drawer,users need to manually close the drawer. This button is grayed
during test running, and it can not be manipulated.

1.3 Rinse Maintenance

Click can open rinse tip interface,as shown below. After setting the appropriate parameters
can rinse the tip.

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Fig. 10.2 Tip rinse parameters


1.4 Platform Debugger

Click Into the platform position debug Interface.

Note:Maintenance Engineer has been complete the calibration for the platform position,
non-professionals here can not do any changes for the platform position information.

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Appendix III System Parameters

Select "System" in the left column to go into the instrument system parameter interface, as shown below:

Fig. 11.1 System Parameters


1.1 Liquid Parameters Editing

Click to go into the interface of liquid parameters editing.

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Fig. 11.2 Liquid parameter editing

Here, you can create, delete, and modify the parameters of various types of liquid. In the parameters
interface you can set the detailed parameters of suction, liquid injection and rinse. These parameters setting
will affect the absorption, liquid injection precision, as well as the degree of sample cross-contamination.
So, these liquid parameters were tested and verified by experiment should be set to the default parameters
that cannot be altered.

1.2 Experimental Projects Editing

Click to the experimental projects editing interface.

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Fig. 11.3 Experimental project definition

You can create, delete, modify and save the Experimental projects in this interface.
1.2.1 Micro Gel Immunoassay Definition

Fig.
11.4 Blood Card information definition
Ref NO: Delimit the micro gel card number that the test project uses.
Product barcode:Delimit barcode rules of micro-gel card.
Card Name:Delimit the name of micro-gel card that is the name of the test project.
Test/Card :Delimit the number of detected specimens of such micro-gel card.
Cell Definition:Setting the holes mark of micro-gel cards and use“|”to block off them.

: Choose whether you want to do the cross match process.


1.2.2 Blood Dispensing Parameters

Fig. 11.5 Blood pipetting parameters setting


Sample Vol(ul):Set uptake of blood specimens for dilution.
LISS Vol(ul):Set uptake of LISS solution for dilution.
Sample Liquid:Select liquid parameters that the sample used.
LISS Liquid:Select liquid parameters that the LISS solution used.
Mix Vol(ul):Set the mixing liquid volume of the dilution.
Mix Cycle:Set the mixing times.

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Mix Liquid:Select liquid parameters that the mixture used.


Asp Vol(ul):Setting the fluid volume that added to each micro-gel pores.
Cell sequence:Setting the pipette holes of blood samples, If the test is cross-matching of blood, here can set
the pipette holes of blood samples for donee and use“/”to block off them.
Donor sequence:When do cross-matching of blood test, setting the pipette holes of blood samples for
donor and use“/”to block off them.
1.2.3 Serum Dispensing Parameters

Fig. 11.6 Serum pipetting parameters setting


Sample Vol(ul):Setting the sample volume of serum samples
Serum Liquid:Setting liquid parameters that used to add serum samples.
Cell sequence:Setting the pipette holes of serum samples, If the test is cross-matching of blood, here can
set the pipette holes of serum samples for donee and use“/”to block off them.
Donor sequence:When do cross-matching of blood test, setting the pipette holes of serum samples for
donor and use“/”to block off them.
1.2.4 Reagents Dispensing Parameters

Fig. 11.7 Reagents pipetting parameters setting

Full in pipetting volume of reagents in ,select liquid parameters that used for

reagents pipetting in ,full in the pipette holes of reagents in


( Use“/”to block off them when there are a plurality of holes ) , select reagent names

in and then click to add reagents pipetting parameters to the list.


1.2.5 Incubation Parameters

Fig. 11.8 Incubation parameters setting


If the test does not need incubation, then set unchecked state in . If some test need incubation
steps,then check in and full in target temperature of incubation in ,full in
Incubation time in .

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1.2.6 Centrifugal Parameters

Fig. 11.9 Centrifugal parameters setting

If the test requires centrifugal,fill in the centrifugation speed, centrifugation time that the test required in
the centrifugal parameters setting interface, and then click to add centrifugal parameters to the list.
You can also check the centrifugal parameters in the list and click the "Delete" button to delete them.

1.3 Reagent Information Edit

Click to go into the interface of reagent information definition.

Fig. 11.10 Reagent Information setting

In this interface,you can create new reagent types and information, or to delete the existing reagent types.
As follow there are meanings of each reagent information in the formula bar:
Ref.NO:Reagents type number.
Reagent Name:Delimit reagents name.
Barcode:Delimit the barcode rules of reagents.
Volume(ml):Delimit the maximum capacity of this type of reagent bottles.
Type:To delimit the type of this reagent belongs.
Token Color:Set the color of the reagent displays in the interface.

Click ,fill in the appropriate information in the reagent information bar,and then click ,
you can complete the definition of an agent.

Selected a reagent in the left column and then click to delete this reagent.

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1.4 System Parameter Setting

Click “System Setting” to get into system setting page.

Fig 6.2 Setting page

1.4.1 “Setting” Main Interface

Default value is 1000,this parameter is called by system when device is washing probe
during initialization period.

: The interval time of liquid level


detection of system liquid bottle and waste liquid bottle. The default value is 1 minute, it’s could
be customized.

: Whether prompting user to reset LISS bottle


after putting bottle into slot.

: Use probe to mix reagent before aspirating.

: Use blender to mix reagent.

: Setting the result files


export directory. Default directory is “D:\ OUTPUT\”.

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1.4.2 Prompt Option

The prompt option is shown as below, the options in this setting page are prompt for test
preparing or test running.

Fig6. 3 Prompt option

: The default waste liquid warning volume is 95%


of whole range, if waste liquid volume is more than this threshold, system will give warning and
pause test until user pour out the waste liquid. The default system and maintenance liquid
warning volume is 10% of whole range, if system or maintenance liquid volume is less than this
threshold, system will give warning and pause test until user fill liquid.

1.4.3 Centrifuge and Incubator Parameter Setting

: If this option is selected, before centrifugation,


system will calculate according some rules to judge whether to wait next batch cards to
centrifuge with current cards together.

Centrifuge speed and centrifuge time should be set according to specification of gel card.

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Fig 6.4 Centrifuge and incubator parameter

Appendix 4 Errors and Prompt

Across System has excellent error-correction system, when there is error occur, system will
apply user to give order to correct current faulty movement and continue to work remaining test.

1.1 Motor Initialization Error


During running, if bellow information window comes out, it means corresponding motor
initialized unsuccessfully.

Note: During pipette Arm Z motor initialization, the blocking sheet failed to move out from
optical sensor.

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Note: During initialization, optical sensor doesn’t sense the blocking sheet.

1.2 Liquid Level Detection Prompt


Example 1: If probe doesn’t detect liquid level for one time, it will go to detect 2 more
times, if it detects liquid successfully in these period, it will continue to work, if it still couldn’t
detect liquid, system will show this hint:

Click , probe will detect again.

Click , system will skip the sample, the sample will be


displayed failed in interface and big gripper will transfer this card to waste bucket.

If user has no any operation with , after 60 seconds, system


will skip this sample and the sample will be displayed failed in interface and big gripper will

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transfer this card to waste bucket.

If user needs to deal with this sample, user could move the cursor and left click any other
area in this hint window, the countdown will be aborted, after sample dealing, click “retry” to
continue test.

Example 2: If there is nothing detected or not enough liquid detected when probe is
detecting reagent, system will show this warning:

Click , probe will detect again, if enough liquid is detected, system will
continue to work, if no, this hint window will come out again.

Click , probe will go to z-max position to aspirate liquid and continue


to run test.

1.3 Big Gripper Catching Card Failure


Example 1: If there is no card caught in drawer, system will show this widow:

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Click , gripper will grip card again at same position.

Click , big gripper will skip this position and move to next card and catch.

Click , gripper will ignore this error and continue next step.

1.4 Centrifuge Imbalance Error


When imbalance occurs during centrifugation due to imbalance card or other issues, system
will stop centrifugation and give this information:

Click “OK”, big gripper will transfer the cards in centrifuge to original position and
continue next batch of sample.

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