LD-500/LD-520

Automated HbA1c Analyzer

Operation Manual

For In Vitro Dianostic Use

LABNOVATION TECHNOLOGIES, INC.

General Description
Thank you for choosing our LD-500/LD-520 Automated HbA1c Analyzer.
Before using, please read this operation manual carefully for the proper use of this product.
After reading this operation manual, please make sure it is properly kept so that it is readily available
for future reference.

Product Name: Automated HbA1c Analyzer

Model: LD-500/LD-520
Shelf Life: 5 years
Manufacturing Date: See the label

Product Registration Number: GDFDA (A) No. 20142400220

Product Standard Number: YZB/GD 2067-2014
Product License Number: GDFDAPL No. 20010427

Manufacturer: Shenzhen Labnovation Technologies Inc.

Registered Address: F1 East, W2-B, Keji South 2nd Road, Hi-tech Industrial Park, Nanshan,
Shenzhen, China
Production Address: F2 East B, Gaofa Plant Building No. 7, Maotoushan Gaofa Industrial District,
Beihuan Road, Nanshan, Shenzhen, China
After Service Provider: Shenzhen Labnovation Technologies Inc.
After Service Address: F2 East B, Gaofa Plant Building No. 7, Maotoushan Gaofa Industrial District,
Beihuan Road, Nanshan, Shenzhen, China

Tel: 0755-86667926 Fax：0755-86667510-805

Release Date: March 10, 2015

Version Number: V1.8

Intellectual Property
Shenzhen Labnovation Technologies Inc. (hereinafter referred to as Labnovation) owns the copyright
of this unpublished manual and has the right to treat the manual as confidential information. This
manual is only intended to assist the user in the use of LD-500/LD-520.

This manual and all of the intellectual property rights related to this manual (including copyright) are
kept by Labnovation. Without prior written consent of the manufacturer, any materials contained in
this manual shall not be photocopied, reproduced or translated into other languages. Labnovation
has the authority regarding to the final interpretation of this manual;
Labnovation reserves the right to upgrade the product technology without prior notice;
Labnovation reserves the right to modify the product specifications without prior notice;
Labnovation reserves the right to revise the instruction manual without prior notice;
Declaration
Labnovation shall not provide warranty of any kind for this information, including (but not limited to)
any implied merchantability or suitability warranties for certain purposes.

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The LD-500/LD-520 analyzer described in this manual is subject to continuous improvement and
perfection. Labnovation shall reserve the right to modify the device structures, reagent types, and
technical details at any time.

Labnovation shall not bear any responsibility for result errors, instrument failures, or other problems
caused by the user‟s failure to adhere to the procedures and warnings.
Labnovation is only considered responsible for the safety, reliability, and performance of this
instrument under the conditions as follows:
All installation operations, modifications, and repairs of this product are conducted by the
Labnovation authorized professionals;
The instrument is operated in accordance with the instructions in the operation manual;
The relevant electrical installation shall comply with the applicable national requirements.

Labnovation shall not be responsible for the safety, reliability, and performance of the product if any
of the following occurs:
The product has reached the expiration date;
Any assembly has been removed and/or re-commissioned;
The product has not been operated in accordance with the operation manual.

Warranty
Scope of the Free Maintenance Services:
Free service is provided for any devices that are within the scope specified by the Labnovation
warranty rules.
Scope of Paid Services
Labnovation offers paid service for any devices that are beyond the scope specified by the
Labnovation warranty rules;
Even during the warranty period, Labnovation shall only offer paid services for the products that are
in need of repair due to the following causes:
Improper use;
Human caused damage;
Replacement of parts unapproved by Labnovation;
Repair of the instrument by personnel unauthorized by Labnovation;
Usage of grid voltage beyond the specified range of the device;
Force majeure natural disasters.

Labnovation shall bear responsibility for the safety, reliability, and performance of this instrument only
under the conditions as follows:

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This instrument is only intended for use by the physicians or qualified professionals trained by
Labnovation or Labnovation‟s agents.
It is important for the hospital or organization that uses this instrument to execute a reasonable
service/maintenance plan. Neglect of service/maintenance may cause instrument breakdown or
injury to human health.
If any problem occurs, please perform the troubleshooting procedures in accordance with Chapter 8.
If the problem still exists, please contact the Labnovation service department for help.
Please make sure that this analyzer is used under the conditions specified in the instruction manual.
The incorrect instruction may result in abnormal operation of the analyzer, unreliable measuring
results, and possibly cause damage to parts of the analyzer or even personal injury.

The instrument should be inspected strictly before unpacking. In order to avoid breakage in
transportation, the instrument is carefully packaged. When receiving the analyzer, please carefully
check if there is physical damage in the packaging. If the packaging is damaged, please contact our
services personnel.
Please always keep it upward when unloading and delivering the instrument.. Never tilt or roll the
instrument. The foam inside the box can prevent shock to a certain extent during the handling of the
instrument. Minimize the vibration during handling. After handling, perform checks and debugging.
Do not use the device in close proximity to any sources of strong electromagnetic interference.
Make sure the analyzer is properly grounded before switch on power.

Note
This user manual is intended for the following professionals:
Personnel who perform the daily operation of the system;
Personnel who perform system maintenance and troubleshooting procedures;
Personnel who are learning to operate the system;

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Symbols
Symbols used in this manual:

Symbols Meaning
The operator is required to follow the procedures under this symbol.
The incorrect operation may result in personal injury.
The operator is required to follow the procedures under this symbol.
The incorrect operation may cause malfunctions or damages to the
product or affect the test results.
The operator is required to follow the instructions under this symbol.
The instructions will emphasize important information or information
that requires particular attention of the operator.
The operator is required to follow the procedures under this symbol.
The incorrect operation may risk the operator under biohazard.
The package should be always kept upright during the transportation

The transport package should be kept dry

The transport package contains fragile components and should be

handled with care.

This symbol indicates the maximum number of layers that the

transport packages of this category can be stacked

Do not dispose in domestic waste. Device contains Li-ion batteries.

Dispose of the device only according to the regulations obtained in
the country at hand.

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 Table of Contents
Chapter 1 Introduction ................................................................................................................ 1
1.1 Product Usage .................................................................................................................. 1
1.2 Principles .......................................................................................................................... 2
1.3 Basic Parameters .............................................................................................................. 3
1.4 Specification ...................................................................................................................... 4
1.5 Product Features ............................................................................................................... 4
1.6 Operation Conditions ......................................................................................................... 4
1.7 Reagent ............................................................................................................................ 4
1.8 Accessories ....................................................................................................................... 5
Chapter 2 System Introduction.................................................................................................... 6
2.1 Instrument Appearance ..................................................................................................... 6
2.2 Front View of the Instrument.............................................................................................. 6
2.3 Rear panel of the Instrument ............................................................................................. 7
Chapter 3 Installation .................................................................................................................. 9
3.1 Installation Conditions ....................................................................................................... 9
3.2 Unpacking and Installation ................................................................................................ 9
3.3 Tubing Connection and Reagents Installation ................................................................. 10
3.4 Pump Tubing Installation ................................................................................................. 10
3.5 Column Installation .......................................................................................................... 12
3.6 Printer Paper Installation ................................................................................................. 12
3.7 Power Connection ........................................................................................................... 12
3.8 Change Reagents ........................................................................................................... 13
Chapter 4 User Menu ............................................................................................................... 14
4.1 Main Menu ...................................................................................................................... 14
4.2 Calibration ....................................................................................................................... 15
4.2.1 Circumstances requiring calibration ......................................................................... 16
4.2.2 Calibration Options .................................................................................................. 16
4.2.3 Calibration screen .................................................................................................... 16
4.2.4 Manual Calibration ................................................................................................... 17
4.2.5 Automatic Calibration ............................................................................................... 17
4.2.6 Calibration Data ....................................................................................................... 19
4.3 Run ................................................................................................................................. 20
4.3.1 Sample Info Edit Screen .......................................................................................... 21
4.4 Search............................................................................................................................. 25
4.5 QC .................................................................................................................................. 28
4.5.1 Enter the QC Screen................................................................................................ 28
4.6 Maintenance.................................................................................................................... 29
4.6.1 Cleaning .................................................................................................................. 29
4.6.2 Sterilization .............................................................................................................. 30
4.6.3 Change Reagents .................................................................................................... 30

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 4.7 Diagnosis ........................................................................................................................ 31
4.8 Settings ........................................................................................................................... 32
4.8.1 Date/Time setup....................................................................................................... 32
4.8.2 Language Setup ...................................................................................................... 33
4.8.3 Printer Setup ............................................................................................................ 33
4.8.4 Parameter setup ...................................................................................................... 33
4.8.5 Engineer .................................................................................................................. 34
4.9 System Info ..................................................................................................................... 35
Chapter 5 Operation ................................................................................................................. 36
5.1 Preparation Before Operation .......................................................................................... 36
5.2 Turn on the Analyzer ....................................................................................................... 36
5.3 Quality Control ................................................................................................................ 37
5.4 Sample Preparation......................................................................................................... 37
5.4.1 Preparation method of whole blood samples ........................................................... 37
5.4.2 Preparation method for the pre-diluted samples....................................................... 37
5.5 Sample and QC Analysis ................................................................................................. 37
5.6 Turn Off the Analyzer ....................................................................................................... 38
Chapter 6 Precautions .............................................................................................................. 39
6.1 Warning ........................................................................................................................... 39
6.2 Precautions ..................................................................................................................... 39
6.3 Sample Requirements ..................................................................................................... 39
6.4 Calibration and QC Requirements ................................................................................... 40
Chapter 7 Maintenance and Service ......................................................................................... 41
7.1 Maintenance.................................................................................................................... 41
7.1.1 Daily Maintenance ................................................................................................... 41
7.1.2 Weekly Maintenance................................................................................................ 41
7.2 Service ............................................................................................................................ 42
7.2.1 Replace the fuse ...................................................................................................... 42
Chapter 8 Troubleshooting........................................................................................................ 43
8.1 Software and Hardware Malfunctions and Solutions ........................................................ 43
8.2 Abnormal Chromatographic Peaks and Correction Solutions .......................................... 44
Chapter 9 Communication Protocol .......................................................................................... 45
9.1 Communication Protocol for sample results..................................................................... 45
9.2 Communication Protocol for QC results........................................................................... 46

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 Chapter 1 Introduction

1.1 Product Usage

Glycosylated hemoglobin (GHb), also known as HbA1, is a compound formed through the
non-enzymatic action of blood corpuscular hemoglobin and carbohydrate. Depending on the
combined carbohydrate type, GHb can be divided into HbA1a, HbA1b, and HbA1c; where HbA1c
accounts for approximately 80% of HbA1. HbA1c is a stable addition compound formed by the
amino-terminus of one or two β chains of Hb and glucose carbonyl. Due to its obvious positive
correlation with blood glucose concentration, the HbA1c content can directly reflect the blood
glucose control of patients with elevated blood glucose in the past 1 to 3 months, and this has
therefore become the golden standard for the blood glucose control of patients with diabetes.

In 2010, ADA defined HbA1c≥6.5% as the diagnostic criteria for diabetes. People with HbA1c from
5.7% to 6.4% are treated at a high risk of diabetes. IFCC recommends that the results should be
reported both in percentage
and in mmol/mol Hb. NGSP and IFCC suggest that the normal reference interval
of HbA1c should be 4% to 6% and 20 to 42 mmol/mol, and the control objective for patients with

diabetes should be ＜7% and ＜53 mmol/mol, respectively.

LD-500/LD-520 is an automatic instrument used to separate human hemoglobin subtypes and

variants from hemolysed whole blood. This instrument only requires a small volume of sample and is
easy to operate.

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1.2 Principles

LD-500/LD-520 Automated HbA1c Analyzer uses cation exchange chromatography with gradient
elution, to separate human hemoglobin subtypes and variants from hemolysed whole blood.
The glycosylation of hemoglobin will cause loss of cation from the hemoglobin molecule surfaces,
resulting in different positive charges between the various subcomponents
of the glycated hemoglobin and non-glycated hemoglobin. Glycated hemoglobin
has less positive charges and lower binding force, while non-glycated hemoglobin
has more positive charges and higher binding force. When the whole blood solution passes through
the chromatography column, various hemoglobin will combine with the cation exchanger. Eluents
with different pH and ionic strength are used to elute two kinds of hemoglobins with glucose
successively, that is,HbA1(a+b)and HbA1c. Subsequently, the non-glycated hemoglobin (HbA0) that
has the highest binding force is eluted. The separated hemoglobin eluent flows consecutively
through the colorimetric cell. The separated hemoglobin fractions are monitored by means of
spectrometer absorption of flight at 415nm. The internal computer is used to record and store the
chromatogram and software is then used to perform analysis of the chromatogram and generates
the result report on a thermal printer. The content of each component is represented by the
percentage of its peak area within the entire blood hemoglobin peak area, i.e., NGSP units. The
IFCC units and average blood glucose concentration can be obtained using the formula from the
NGSP units.
1. The total peak area (Stotal):

Stotal  S HbA1( ab)  S HbA1c  S HbA0

2. HbA1 (a+b) content (%):
S HbA1( a b )
HbA1(a  b)（%）  100
Stotal
3. HbA1 content (%): NGSP units
S HbA1c
HbA1c（%）  100
S total

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4. HbA0 content (%):
S HbA0
0 %）
HbA（  100
S total

5. Total content of glycated hemoglobin (HbA1):

HbA1(%) = HbA1(a+b) content (%) + HbA1c content (%)
6. IFCC units (mmol/mol Hb):
HbA1c mmol/mol = (HbA1c % - 2.15) × 10.929
7. Average blood glucose concentration (eAG):
eAG (mmol/L) = 1.59 × HbA1C% - 2.59

Figure 1-1. Chromatographic analysis of hemoglobin

1.3 Basic Parameters

Test modes: whole blood and pre-dilute mode

Minimal sample volume in sample tube: 1.5 mL.
EDTA-K2 is the recommended anticoagulant.
Sample volume: 15 μL for whole blood mode and 20 μL for pre-dilute mode.
Dilution ratio(pre-diluted mode): Whole blood: Hemolysis = 1:50(20ul whole blood+1000ul
Hemolysis).
Detection wavelength: 415 nm.
Analysis time: 5 min.

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1.4 Specification

Linearity range: 3%-18% for HbA1c; correlation coefficient: r ≥ 0.99.

Reference interval: HbA1c 4%-6% (NGSP units)
Accuracy: The measured results can trace back to the IFCC standard, and the measured values of
controls are within the specified range.
Reproducibility: CV ≤ 3.0%
This product conforms to the requirement of IEC(EN)61326-1 :2013 and IEC(EN) 61326-2-6:2013
for launching noise immunity.

1.5 Product Features

Device type of the tested product: laboratory

Device type: fixed
Overvoltage category: class II
Environmental conditions: standard
Grid connection: removable power cord
Power supply: AC
Input power: 150VA
Operating conditions: continuous
Pollution degree: 2
Instrument weight: 27kg
Instrument dimensions: 610(L) ×435(W)×H425(H)mm

1.6 Operation Conditions

Ambient temperature: 15ºC to 35ºC.

Relative humidity: ≤80%.
Atmospheric pressure: 79kPa to 106kPa.
Power requirements: AC 100-240V, 50-60Hz, 150VA. A 2KVA uninterruptible power supply that is
well grounded (zero voltage <2V).
Miscellaneous: Avoid direct sunlight, dust, corrosive gases, vibrations, and strong electromagnetic
interference.

1.7 Reagent

The contents of the reagents are:

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Description Volume Function
Adjust the PH in the chromatography column to separate
Eluent A 1150ml*2 for 400tests
hemoglobin fractions together Eluent B.
Adjust the PH in the chromatography column to separate
Eluent B 800ml*2 for 400tests
hemoglobin fractions together Eluent A.
Hemolysis 2600ml*2 for 400tests Break red blood cell walls and release the hemoglobin.

1.8 Accessories

Description Test volume Function

Pretreatment Column 400tests Used to filter the particles in the sample.
Chromatography Contains cation resins for hemoglobin fractions
400tests
Column exchange.
Installed on the six-way valve to adjust the flow of Eluent
Pump Tubings 800tests
A and Eluent B.

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 Chapter 2 System Introduction
LD-500/LD-520 Automated HbA1c Analyzer is fully automated instrument for hemoglobin analysis. It
features a color touch screen, high capacity autoloader, and only requires a small volume of sample.
It‟s ideal for mid-sized laboratory.

2.1 Instrument Appearance

Automated HbA1c Analyzer consists of an auto loader, a chromatography system, a signal

processing and control system, and a display and printing system. The accessories include
chromatography columns and pump tubing.

Figure 2-1. Instrument Appearance

Section Description and function

① Thermal printer: Used to print the results.
Display: An touch screen with a LCD display. The operation of the analyzer is entirely via
②
the touch screen.
Sample process unit: The instrument can automatically aspirate, mix and analyze the
③
samples. 4 racks can be put in one time and continuously loading is supported.

④ Auto-loader: 4 racks can be loaded at one time, with 10 samples on each rack.

2.2 Front View of the Instrument

Open the left front panel of the instrument to see the components shown in the figure as below:

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 Figure 2-2. Front view of the instrument

Section Description and function

① Peristaltic pump: A multi-channel peristaltic pump is used to drawing in and dispensing
reagents for column elution and wash the probe. The pump also controls the flow of waste
to the waste container.
② Six-way valve: Switching between sample and reagent.
③ Pre-column and holder: a holder which has a threaded clamp to hold the column in place;
the pre-column is for preliminary filter.
④ Column and holder: a holder which has a threaded clamp to hold the column in place; the
column contains cation exchange resin for the separation of glycated hemoglobin.
⑤ Detector:Used to record and convert the detectable electric signal so that a chromatogram
can be obtained.
⑥ Sample probe: Used to pierce the vacuum tube cap and aspirate the blood sample.
⑦ Mixer: Grab the tube and mix the sample if mode is selected as whole blood.
⑧ Syringe: Used to meter and aspirate the sample as well as aspirate the hemolysis.

2.3 Rear panel of the Instrument

Figure 2-3. Rear panel of the instrument

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Section Description and function

① Power switch: The instrument is “ON” when the top of the switch („︱‟) is pressed down.

② Fuse: It is used to prevent damage from over-current or overheating,include two 2A fuse.

③ Power connector: It is used to connect the power cord.
④ RS232: It is used for data transmission.
Waste outlet tube: It is used to dispense waste from LD-500/LD-520. The outlet tube
⑤
should be connected directly to a proper waste container.
⑥ Hemolysis inlet tube: It is used to dispense the hemolysis into LD-500/LD-520.
⑦ Eluent A inlet tube: It is used to dispense the eluent A into LD-500/LD-520.
⑧ Eluent B inlet tube: It is used to dispense the eluent B into LD-500/LD-520.

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 Chapter 3 Installation

Please read the manual carefully before operating the instrument. Incorrect operation may cause
damages to the analyzer and the software.

3.1 Installation Conditions

Automated HbA1c Analyzer should be installed under the following conditions:

 Away from direct sunlight and is dust free.
 Room temperature should between 15ºC and 35ºC.
 Approximately 4inchs (100mm) of clearance behind the analyzer for the waste and reagent
tubing and connection of the power cable.
 The system requires the minimum bench top space of 43.5cm(W)*61cm(L)*42.5cm(H) to allow
for system and plus proper clearances.
 The work bench should have a flat, level surface that is free from vibrations and is capable of
supporting a weight of more than 50kg.
 System input voltage: AC 100-240V; frequency: 50-60Hz; maximum input power: 150VA.

Make sure the analyzer is properly grounded.

Before power on the analyzer, make sure the input voltage meets the requirements.
Before connecting the power cord, make sure the power switch is in “O”.

If the ambient temperature is out of the specified operating range, the analyzer will alarm you for the
abnormal ambient temperature and the analysis results may be unreliable.

3.2 Unpacking and Installation

Please carefully inspect the outer box for any damage. Please contact your local distributor if the
packaging is damaged. The packaging must be opened by qualified engineers. Due to the weight of
LD-500/LD-520, “team lifting” is encouraged, In preventing personal injury or accident. It‟s suggested
that one person be placed left and right, when handling the analyzer.

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3.3 Tubing Connection and Reagents Installation

Please carefully inspect the reagent tubing on the back side of the instrument.
Direct the waste pipe to an appropriate point or our waste bottle. If the waste bottle is missing, a
plastic bottle with the same functionality can be used instead.

Dispose of the waste in accordance with local regulations.

Connecting the different reagent tubing with the analyzer respectively, remove the caps from the
reagent bottles and place the reagent tubing into the bottles. Ensure that they are fitted correctly.

Only the reagents specified by the manufacturer can be used.

Before use, Stewing the reagent for a while and wait for stabilization.
Please make sure that the reagents and columns are used before the expiration date.
After connecting the reagents and the analyzer, cap the reagent bottle to prevent contamination of
the reagents.

3.4 Pump Tubing Installation

1. Open the left front panel of the instrument to find the peristaltic pump components, as shown in
Figure 3-1.

Figure 3-1 Peristaltic pump components

2. Undo the 5 white plastic clips which hold the pump tube cassette in place. At the top right of each
clip. There‟s a lever which when lowered, frees the clip.
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3.

Figure 3-2. White clip on the peristaltic pump

4. Take each clip from out.
5. When replacing an used pump tube, pull the black strips( which fit into holes either side of the
base tray) upwards out of the tray.
6. Place the new pump tube over the rollers of the pump. The black tagged tubing should be at the
front with the red at the back. Ensure that the colored tabs are on the right hand side, when
facing the instrument.
7. Insert the black strips into the base tray on both sides of the pump. Working from the back
forwards, place the plastic clips one at a time over the tubing. Ensure that the levers are down
and are installed at the right hand side of the pump.
8. Pull the tubing through the sides of the clip from right to left to secure it. Ensure that the colored
tag engages the lug.
9. When the tubing is in place, move the lever upwards and push fully across, then fasten the
control lever to horizontal position in 110~120°, as shown in Figure 3-4.

Figure 3-3. Peristaltic pump tubing

Figure 3-4. Peristaltic pump

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3.5 Column Installation

The instrument can be left powered on when replacing the column.

Open the left front panel of the instrument to find the column and its bracket component, as shown in
Figure 3-5.

Figure 3-5. Column holder

1. The instrument is shipped with a blue and an orange column blank in place. Unscrew the knurled
nut counter-clockwise. When the nut has been raised sufficiently, remove the blank column.
2. Take the pre-column (blue) and the column (orange) out from the reagent kit. The column
consists of a short length chromatography column mounted in a color coded orange, plastic
housing. Install the blue column on the left, and the orange column on the right.
3. Position the column so that the bottom of the column (narrower section) fits into an indentation
on the place the bottom tray (as shown in Figure 3-5).
4. Finger tighten the knurled nut, until it fits securely into top of the column.

3.6 Printer Paper Installation

Paper width: 80 mm
Take the thermal printer tray out of the instrument.
With the printer in the correct orientation, feed the edge of the paper through the stainless steel
rollers at the back of the printer head.
Press the reprint icon on the main menu screen and use the paper feed facility to feed the paper
through the printer head.

3.7 Power Connection

1. Connect the power cord to the power outlet.

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2. Switch on the main switch of the power outlet.
3. Turn the power supply on(switch to (I) position).

A reliable grounded power source should be used for LD-500/LD-520.

3.8 Change Reagents

1. Go to “MAINTAIN-CHANGE KIT” interface, click Eluent A, Eluent B, COLUMN and

HEMOLYSIS and then click PRIME to change reagents.
2. After prime finished, go to “RUN” to check whether the AD valve on the top right corner is stable
and within 20000~36000. If yes, the analyzer is ready to do test; if AD valve is not stable and
less than 20000, keep priming again. When change reagents in different lot number, 3 times of
priming is suggested.

Figure 3-6 Changing Reagents

Figure 3-7 Testing Interface

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 Chapter 4 User Menu
This chapter mainly introduces the operation menu in the software of LD-500/LD-520.

4.1 Main Menu

After startup, the screen is light up and the system automatically perform self-test and reagent
priming (as shown in Figure 4-1). Then the main menu is displayed (as shown in Figure 4-2),
indicating that Automated HbA1c Analyzer is ready. Pressing an icon to enter submenus.

Figure 4-1. System self-test and reagent priming

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 Figure 4-2. Main menu

Button Function
Description
Run Initiates the process and begin an analytical run.
Data Enter the Search menu to view the test data information for samples and
controls.
Calibration Enter calibration menu screen to perform calibration.
QC Enter the QC menu to set the quality control level and relevant data.

Maintenance Accesses the maintenance menu.

Diagnosis Enter the Diagnosis menu to perform the system diagnosis operations.
Set: Enter the Set screen to set the system parameters, such as date, quality
control, language, and printing.
System Info Display the system information.
Shut down Shut down the analyzer.

4.2 Calibration

The purpose for calibration is to ensure the accuracy of analyzer. Please follow the requirements to
perform calibration program.
After replacing the reagents or column, we suggest calibration or entry the calibration parameters
provided by the manufacturer.

The test results by automated HbA1c analyzer can be used as valid data only after calibration.

15
4.2.1 Circumstances requiring calibration

Under the following conditions, the operator must calibrate the analyzer:
■ First time installation;
■ The column is replaced;
■ New pump tubing is installed or the pump tubing has been used for a long period so that the fluid
flow is unstable;
■ Change a new batch of reagent kits.
■ The analyzer is unused for a long time.
■ Obvious deviation is found in the system when running the QC.

4.2.2 Calibration Options

The automated HbA1c analyzer allows users to perform either automatic calibration or manual
calibration.

4.2.3 Calibration screen

Press the Calibration icon on the main menu to enter the Calibration menu as shown in Figure 4-3.

Figure 4-3 Calibration menu

Button Function
Description
Manual Enter the Manual Calibration screen and input the calibration parameters.
Auto Enter the Automatic Calibration screen and perform the automatic calibration
program
Search Enter the Calibration data Search screen

The symbol“ ” on the top right of the screen is the Back icon. Press it to return to the main menu.

16
4.2.4 Manual Calibration

The operator has the option to manually input the calibration parameters to calibrate the analyzer.
Press the “Manual” icon on the Calibration screen to enter manual calibration (Figure. 4-4).

Figure 4-4 Manual Calibration screen

Press Edit icon to enter required information. Use the number keys to enter new values.

Figure 4-5. Manual Calibration Edit screen

Check the newly entered value and then press OK button to save the data.
Press Cancel button to abandon the edition.

Press “ ” on the top right of the screen to return to the previous screen.

4.2.5 Automatic Calibration

Press “Automatic” icon to enter the Automatic Calibration screen (Figure. 4-6) and perform the
automatic calibration.

17
 Figure 4-6. Automatic Calibration screen

Press Edit button to entry second level menu, use number keys to enter the values for Low calibrator
value and High calibrator value(Figure 4-7).

Figure 4-7. Automatic Calibration Edit screen

Press Start button to enter the automatic calibration program. A prompts message will be displayed
as below.

Figure4-8 Prompts in auto calibration screen

Ensure that the 3 pre-diluted blood samples, low level calibrators and high level calibrators are put
on the rack in sequence, as shown in Figure4-8.

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● Calibrators are potentially infectious. To protect your safety, please wear proper personal
protective gears (lab coat, gloves, etc.) and follow the laboratory operation procedures when
performing calibration in the laboratory.

● Operator should use the specified calibrators for calibration; Labnovation shall not be
responsible for the calibration results errors caused by the use of other brand calibrators.
● Please refer to the instructions for the use and storage of the calibrators.

The calibration procedures are as follows:

1. Put 5 empty tubes in the sample rack in sequence (here we defined as No1, 2, 3, 4, 5tubes).
2. Add 1000 μL of hemolysis in each tube. The tube should not contain EDTA-K2,otherwise it should
be washed twice by 1ml hemolysis befor using.
3. Prepare 3 patients samples, respectively add 20ul blood sample into No1,2,3 tubes. Respectively
add 20ul low level calibrators in No.4 tube and high level calibrators in No.5 tubes, properly put
on the cap and gently shake the tube.
4. Enter the assigned value of the low level and high level calibrators via number keys on the
screen.
5. Press OK button to start the calibration process. After the analysis is completed, the new slope
and new intercept will be automatically calculated and displayed.
Attention:
1. You have to press accept button to use the new intercept and slope after calibrated. If the new
intercept and slope are abnormal, press the return button to use the old intercept and slope or
calibrate it again.
2. If you choose Calibrate Double Sample, the calibrator of 4th and 5th tube will be aspirated and
tested two times. The slope and intercept will be calculated by the mean value.
3. If the Mean value(low) is more than 20% compare to Low value, the calibration will fail. The same
as High value.

4.2.6 Calibration Data

Press the Calibration Search button to find the historic calibration factors as shown in Figure 4-9.

19
 Figure 4-9. Historic calibration parameters

Press the symbol“ ”on the top right of the screen to return to previous menu.

4.3 Run

Press Run icon on the main menu to initiate the process and begin an analytical run. See Figure 4-10

Figure 4-10. Sample run screen

20
Button Description Function
No. Indicates the sample sequence number.
Rack Indicates the rack number in the auto-loader
Tube Indicates the tube position in the sample rack
Mode Display the sample type: whole blood or pre-dilute.
Status Display the working status of the analyzer.
Sample info edit Enter the Sample information.
Run Start the sample processing in the auto-loader according to the sequence
number.
Stop Stop the current test.
Return Return to the previous menu.

4.3.1 Sample Info Edit Screen

Press the Sample info edit icon to enter the Sample info edit screen as shown in Figure 4-11. The
sample ID; rack number, tube number are input, and the sample mode as whole blood or prediluted
mode is selected on this screen.

Figure 4-11. Sample info edit screen

Button Description Function
Sample ID The sample identification is entered automatically by the barcode reader.
Quantity Enter the quantity of samples.
Rack Enter or display the sequence number of the sample rack
Tube Enter or display the sequence number of the tube in the rack.
Mode Select test mode as whole blood, pre-dilute, or QC.
Add Add a sample for testing.
OK Confirm the input of this batch and return to the Test screen.

On the Sample info edit screen, press the white box beside “Mode” to enter the Sample mode screen
(as shown in Figure 4-12) and select the sample mode as whole blood, pre-dilute, or QC.

21
 Figure 4-12 Select test mode

Press the white box beside the Sample ID,(as shown in Figure 4-13). A soft keyboard will be
displayed. Use the numeric key or alphabetic characters in the keyboard to enter the sample ID. After
the entry is completed, press Ok button to confirm the entry and return to the previous menu.

Figure 4-13. Entry sample ID

Press the white box beside Quantity, select the number of samples and press Add button to batch
input sample information.(as shown in Figure 4-14)

22
 Figure 4-14. Entry sample ID

Press the white box beside Rack, select the correct rack number. (as shown in Figure 4-15)

Figure 4-15. Rack No. Entry Screen

Press the white box beside the Tube No and select the correct tube No.(as shown in Figure 4-16)

Figure 4-16. Tube No. Entry Screen

After selection of the sample mode, sample ID, rack No, tube No, press OK to confirm the entry and
enter next sample information. Meanwhile, the entered sample information will be displayed in the
worklist, as shown in Figure 4-17). Attention: sample information could be edited or deleted before
pressing OK; but once have pressed OK, sample information can‟t not be edited or deleted again.

23
 Figure 4-17. The entered sample information

If any error occurs in the sample information, press Modify icon in the sample information table and a
prompt box will be displayed (Figure 4-18). Press OK button to perform modification, press cancel to
abandon. (Figure 4-19). After the modification, press Save button to confirm the changes and return
to the previous screen as shown in Figure 4-17;

Figure 4-18. Sample information modification prompt

Figure 4-19. Modification of the sample information

If any sample information should be deleted, press delete icon in the sample information table and a
prompt box will be displayed (Figure 4-20). Press OK button to delete the existing sample
identification information. Press Cancel to abandon the deletion and return to the previous screen.

24
 Figure 4-20. Sample information deletion prompt

Press OK button to store the entered data. The following screen will be displayed in Figure 4-21.
Press Run to start sample processing. Press Add button to add the new sample information. Press
Return button to return to the main screen. While testing the samples, press “Chromatrogram” on the
top left to find the sample chromatogram and the analysis process. Press Stop button to stop test,
analyzer will finish present test and stop next test.
Attention: adding sample is effective before the last rack is pushed out, the analyzer will continue
testing new samples; but once all of rack have been pushed out, although the analyzer may still
running, adding sample is ineffective and analyzer won‟t conduct testing. Therefore, if user need to
add new samples, please input sample info before the last rack is pushed out.

Figure 4-21. Sample run Screen

4.4 Search

Press the Search icon on the main screen to enter the search screen (as shown in Figure 4-22) to
inquire the sample results.

25
 Figure 4-22. Search Screen

Button Function
Search Query the sample data and view the chromatogram of the selected sample.
Print Print the selected data
Print all Print all the selected results in the results table
Export Export the data to computer or LIS
Export all Export all of the data in the results table to computer or LIS
Delete Delete the selected data in the results table.
Exit search screen and return to the main screen

Press search icon on the bottom of the search screen to display the stored sample results sorted by
date in the results table.
If you need to query the test result on a certain day, please follow the below steps:
(1) Check the box beside the date.
(2) Press the white box after the date to indicate the calendar and select the date as shown in Figure
4-23. The left and right arrow at the top of the calendar can be used to select the year and month.
Select the inquiry date in the calendar. Press the “×” on the top right of the calendar to save the date.
(3) Press the Search icon on the bottom of the Search screen to display the test results within the
specified date range in the right box in a chronological order.

Figure 4-23. Select the query date

If you need to query the test result within a certain period, please follow the below steps:
26
(1) Check the box beside the date.
(2) Press the white box after the date to select the start date.
(3) Check the box beside the end date;
(4) Press the white box after the end date to select the end date.
(5) Press the Search icon on the bottom of the Search screen to display the test results within the
specified time period in the right box in a chronological order. If you know the specific information of
the stored sample, such as sample ID, test sequence number, then: (1) Check the box beside the
medical sample ID,test sequence number. (2) Press the white box after the sample ID, test sequence
number and a keypad will appear. Enter the specific information, as shown in Figure 4-24. (3) Press
the Search icon on the bottom of the Search screen to display the test results corresponding to the
sample ID, test sequence number in the right box.

Figure 4-24. Enter and query specific sample information

In the right box, press “Search” to display the test results (Figure 4-25) or press the “Chromatogram”
to show the chromatogram (Figure 4-26).

Figure 4-25. Display the test query results

27
 Figure 4-26. Display the test query figures

4.5 QC

The error may occur during the test process, which will cause a unreliable test results. In order to
ensure the reliability of the sample results, the user is recommended to perform QC on the glycated
hemoglobin with the low and high controls on a daily basis.

4.5.1 Enter the QC Screen

Press the “QC” icon on the main screen to enter the QC screen as shown in Figure 4-27.

Figure 4-27. QC Screen

Enter the assigned value,SD,lot No.,exp. date of the level1 and level2 via number keys on the
screen.
Press the “Search” icon to enter the QC Search screen, you can print QC chart and export QCresults
on the screen as shown in Figure 4-28.You can press any result to edit or delete the QC result.

28
 Figure 4-28 QC Screen
The QC procedures are as follows:
1. Put 2 empty tubes in the sample rack in sequence (here we defined as No.1, 2tubes).
2. Add 1000 μL of hemolysis into each tube. The tube should not contain EDTA-K2,otherwise it
should be washed twice by 1ml hemolysis befor using.
3. Respetively add 20ul level1 and level2 in No.1 and No.2 tubes, properly put on the cap and
gently shake the tube.
4. Enter the Sample Info Edit Screen, choose the “QC mode” to start the QC process.

4.6 Maintenance

Press the “Maintenance” icon on the main screen to enter this screen (as shown in Figure 4-29).
Periodic maintenance is required to maintain the optimum system performance. In this interface, the
system counts usage times of column and pretreatment column which are being used presently.
Press the “Pack up” icon on the main screen to drain the reagent for long-distance transport.

Figure 4-29. Maintenance Screen

4.6.1 Cleaning

In the Maintenance screen, press the “Clean” icon and a prompt box will appear. Press OK icon to
return to the Maintenance screen automatically and a “Cleaning...” message will appear as shown in
Figure 4-30. The display will return to the Maintenance screen after the cleaning is completed.

29
 Figure 4-30. Clean the Tubes

4.6.2 Sterilization

In the Maintenance screen, press the “Decontamination” icon. The Decontamination icon will dim
and “Decontamination...” will appear below as shown in Figure 4-31. The display will return to the
Maintenance screen after the sterilization is completed.

Figure 4-31. Tube sterilization

4.6.3 Change Reagents

Press the “Change Reagents” icon on the Maintenance screen to show the Change Reagents
screen. Press eluent or column button, words under each button will turn white.
Attention: if press column or pretreatment column, and then press Prime, the usage times of column
will return to zero, therefore, do not press column and pretreatment column if only need to prime
reagents. Both column and pretreatment column can do 400 tests, so change new columns the count
is up to 400; press Column and Precolumn and then press Prime to make usage times return to zero.

30
 Figure 4-32. Change the reagents

4.7 Diagnosis

Press the “Diagnosis” icon on the main screen to enter this screen (as shown in Figure 4-33), and
various tests can be performed in this screen.

Figure 4-33. Diagnosis screen

Button Description Function

ADC Display the ADC value detected by the analyzer in real time
LED Press to turn on/off the LED on the analysis head.
Autoloader Press to start the automatic sampling test.
Probe test Press to enter the Sample Probe Test screen.
Syringe Press to enter the Syringe Test screen.
Mixer Press to mix the sample
Pump test Press to go to the Pump Test screen.
Metering valve Press to go to the Metering Valve Test screen.
Temp View the current temperature of the hemolysis bath.
Log Press to go to the Log screen.
Solenoid valve Press to enter the Solenoid Test screen.

31
4.8 Settings

Press the “Settings” icon on the main screen to enter the Setup screen as shown in Figure 4-34.

Figure 4-34. Settings Screen

Button Description Function

Date/Time Press to enter the Date/Time Setup screen.
Communication Press to enter the Communication Setup screen.
Language Press to enter the Language Setup screen.
Printer Press to enter the Printer Setup screen.
Parameter Press to enter the Test Parameters Setup screen.
Engineer Press to enter the Engineer Setup screen.

4.8.1 Date/Time setup

Press the “Date/Time” icon on the Setup screen to enter the Date/Time Setup screen as shown in
Figure 4-35.

Figure 4-35. Date/time setup screen

Press on the displayed values. The value will become red, indicating that it can be modified now.
Press the “Increase” or “Decrease” icon to increase or decrease
the red value to the desired value. After the date and time are correctly set, press OK icon.

32
4.8.2 Language Setup

Press the “Language” icon on the Setup screen to enter the Language Setup screen as shown in
Figure 4-36.

Figure 4-36. Language setup screen

Check the white box before “Chinese” or English, then a “√” symbol appears. Press the “OK” icon.
Press the Back icon on the top right of the screen to return to the Setup screen.

4.8.3 Printer Setup

Press the “Printer” icon on the Setup screen to enter the Printer Setup screen as shown in Figure
4-37.

Figure 4-37. Print setup screen

Check the white box before Automatic Print, then a “√” symbol appears. Then press the “OK” icon,
and the system will automatically print the result after sample run. You can print IFCC unit and HbA1c
normal range, the title of report can be changed. Press the Return icon on the top right of the screen
to return to the Setup screen.

4.8.4 Parameter setup

Press the “Parameter” icon on the Setup screen to enter the Parameter Setup screen as shown in
Figure 4-38. The A1c tag value, A1c normal range, peak distance, and total peak area can be

33
entered and the residual tests of the column can be displayed on this screen.

Figure 4-38. QC parameter setup screen

Press the “Edit” icon and the value in the center of the screen will become highlighted and editable.
Press a value box, press the “X” on the right to delete the existing value or press “0-9” and “•” to enter
new values. When completed, press “OK” to save the newly edited parameters.

4.8.5 Engineer

Press the “Engineer” icon on the Setup screen. A password input box appears. Enter the correct user
name and password to enter the Engineer screen as shown in Figure 4-39.

Figure 4-39. Engineer screen

34
4.9 System Info

Press the “System Info” icon on the main screen to enter the System information screen (as shown in
Figure 4-40). This screen will indicate the instrument model, serial number, software
version,manufacturer, address, telephone number, number of tests, and other related information.

Figure 4-40. System Info screen

35
 Chapter 5 Operation
Please read the instruction manual carefully before operating the instrument in order to avoid any
failure or damages caused by improper operations.

5.1 Preparation Before Operation

Before turning on the power of the analyzer, perform checks in accordance with the following
requirements to make sure the system is ready.
(1) Check whether the eluent A, eluent B, and hemolysis reagents are sufficient.
(2) Check the waste tank to ensure that it is emptied before turning on the analyzer.
(3) Check the fluid line and power supply
-Check if the reagent and waste fluid lines are bent properly connected.
-Check if there is any liquid leak in the analyzer.
-Check if the power plug of the analyzer is inserted safely into the power outlet.
(4) Check the printer
Check if the printing paper is sufficient and that the installation is proper.

● Samples, controls, calibrators, columns, pre-columns, and wastes are potentially infectious.
Please wear the proper personal protective gears and follow the safe laboratory procedures when
handling products in the laboratory.

● The operator has the obligation to dispose of the reagents, waste, samples, consumables, etc.,
in accordance with local and national regulations.
● The reagents are irritating to eyes, skin, and mucosa. Please wear the proper personal
protective gears (lab coat, gloves, etc.) and follow the safe laboratory procedures when handling
reagent related products in the laboratory.

5.2 Turn on the Analyzer

The power switch is located in the lower right corner at the back of the analyzer. Toggle down to turn
off the analyzer and toggle up to turn on the analyzer.
After the startup, the analyzer will first perform the self-test and automatically clean the system for 5
minutes.
After passing the self-test, the main screen appears and the analyzer is ready to work.

● Self-test and startup initialization must be performed during the initial startup each day;
36
otherwise, the analyzer may malfunction or produce the wrong results.

5.3 Quality Control

In order to ensure reliable results, QC analysis shall be performed on the analyzer each day before
sample analysis. See Chapter 4 for specific information on QC analysis operations.

5.4 Sample Preparation

The samples include whole blood samples and pre-dilute samples.

Whole blood samples are collected from vein blood and kept in a vacuum tube containing the
EDTA-K2 anticoagulant.
For pre-diluted samples, calibrators, controls, or pre-diluted sample should be lysed outside the
machine.

5.4.1 Preparation method of whole blood samples

(1) Use a EDTA-K2 (1.5mg/mL to 2.2mg/mL blood) anticoagulating.

(2) vacuum blood collection tube to obtain the venous blood samples.
(3) Quickly mix the venous blood and the anticoagulant in the tube.
Place the sample tube into the rack for testing.

5.4.2 Preparation method for the pre-diluted samples

(1) Insert 1000 μL of hemolysis into a test tube. The tube should not contain EDTA-K2,otherwise it
should be washed twice by 1ml hemolysis befor using.
(2) Add 20 μL of venous whole blood or finger peripheral blood. Properly put on the led and gently
shake the tube.
(3) Place the tube into the sample holder for testing.

5.5 Sample and QC Analysis

Place the whole blood samples and controls in the rack separately.
Enter the information such as sample ID, and initiate the analyzer to perform the analysis.
After the analysis is completed, the HbA1c values will be displayed in the results table and can be
queried or printed as required.

37
● When the analyzer is running, do not open the front cover or put your hand under the piercing
needle; otherwise, you may be stabbed and injured.

5.6 Turn Off the Analyzer

Remove the sample holders and samples.

Enter the “Maintenance” screen from the main screen and select “Clean.”
After the cleaning is finished, press the power switch icon on the back of the analyzer.

38
 Chapter 6 Precautions
During the analyzer operation process, strictly follow the operation requirements and pay close
attention to the key points of this chapter.

6.1 Warning

(1) All of the samples shall be treated with caution. Please wear gloves before handling samples and
waste materials.
(2) The reagents provided by the reagent kit contain 0.02% sodium azide. Avoid skin or eye contact
or oral ingestion. When there is accidental contact with skin or eyes, wash thoroughly with water and
seek medical attention. If accidentally ingested, wash the mouth thoroughly with water, drink plenty
of water, and seek medical attention.
(3) Dispose of the waste safely in accordance with the local regulations. Prevent the waste
containing sodium azide from contact with heavy metals in order to prevent the formation of
explosive ingredients, and prevent the waste containing sodium azide from contact with acids in
order to prevent the release of toxic gases.

6.2 Precautions

(1) Uses AC 100-240V AC power source. The equipments connected to the external ports must
comply with the national security certification.
(2) Do not use expired reagents and columns. Do not use the column anymore after specified
number of tests by Labnovation.
(3) If the analyzer will be left unused for a long period, discharge the fluid in the lines (remove Eluent
A, Eluent B, and hemolysis and perform cleaning for 3-5 times purge the lines), turn off the power
switch, and disconnect the power cord.

6.3 Sample Requirements

The sample can be venous blood or peripheral blood.

EDTA-K2 is the recommended anticoagulant. The anti-coagulating whole blood samples can be
stored for 7 days at 2ºC to 8ºC.
Sample tubes with caps must be used; otherwise, the sample mixer will not work.
The 13mm×75mm vacuum blood collection tubes containing EDTA-K2 anticoagulant is
recommended.

39
6.4 Calibration and QC Requirements

Please refer to the calibrator instruction manual for the calibrators.

Please refer to the control instruction manual for the controls.

40
 Chapter 7 Maintenance and Service

The user may replace the pump tubing, reagents, printing paper, and fuses on this analyzer. The
other components cannot be replaced with alternatives; otherwise, the company shall not be
responsible for any problem that may occur.

7.1 Maintenance

7.1.1 Daily Maintenance

(1) Before startup and during the tests, visually inspect if there is any fluid leak. If any leak is found,
please contact the engineer.
(2) Before analysis, test the analyzer and confirm that the printing paper is sufficient.
If the paper is not sufficient, please replace a new roll of paper.
(3) Check if the reagents are sufficient and if the waste fluid is overflowing. Add reagents and empty
the waste bottle if needed.

7.1.2 Weekly Maintenance

(1) Clean the analyzer on a regular basis. Use distilled water or 75% alcohol to clean
the analyzer housing, autosampler component, sample holders, and sample probes.
(2) Check if the peristaltic pump is working properly. If not, please contact a local engineer.

Wear gloves when cleaning the analyzer. Use gauze dipped in distilled water or
75% alcohol to clean the analyzer. When wiping, prevent the liquid from flowing
into the instrument and result in damage to the analyzer.

41
7.2 Service

7.2.1 Replace the fuse

Install the fuse in the fuse box for the power supply part.
1. First, disconnect the power cord and then open the fuse box.
2. Insert a screwdriver into the edge of the fuse box and pry it open gently.
3. Remove the fuse tube and replace it when needed.
WARNING: To avoid fire, only the fuse with the same model as the original fuse of the analyzer
(T1AL250V) can be used.

42
 Chapter 8 Troubleshooting

If any of the problem listed below occurs before or during the application of the analyzer, please
troubleshoot it in accordance with the relevant procedures. If the problem persists, please contact
the Labnovation service department for solutions.

Repair of this instrument can only be conducted by the manufacturer, maintenance organizations, or
engineers approved by the manufacturer.

8.1 Software and Hardware Malfunctions and Solutions

Problem Possible Causes Recommended Solutions
After turning on 1. Power failure 1. Check the power supply conditions
the power switch, 2. Main power fuse for the power input source and the
the analyzer does failure main board.
not work and the 3. Main power 2. Replace the fuse.
LED does not switch failure 3. Seek technical support.
light up
Software Fail to start the Turn off the power and restart.
problems system or error Seek technical support if the problem
during the persists.
operations
Data exporting 1. The printer 1. Seek technical support.
papers do not heads are not 2. Use the paper supplied by this
show arranged company
some lines or the in rows or need
lines are too light to be replaced
2. Incorrect use
of paper
The tube holder is 1. The tube holder 1. Place the tube holder so that it is
stuck in the is not properly parallel to the analyzer front
sample loading positioned 2. Seek technical support
slot 2. The holder
loading valve runs
too fast

43
8.2 Abnormal Chromatographic Peaks and Correction Solutions
Problem Possible Causes Recommended Solutions
No peaks in the 1. There is air in the 1. Perform system priming for 1
chromatogram syringe line or the system to
No data is is not properly primed 2 times.
displayed on the 2. The sample is clotted 2. Check if the sample is
report or missing condensed or too low.
3. Leak in the lines Re-prepare and run the
4. Blocked sample probe samples.
5. The metering valve is 3. Seek technical support.
not in position 4. Seek technical support.
5. Use the metering operation in
the diagnosis screen to
diagnose the problem.
Abnormal peak 1.Expired, contaminated, 1. Replace the reagent kit.
shape or damaged reagent kit 2. Replace the column.
2.Expired or damaged
column
Calibration failure 1. Wrong data entry 1. Input the correct fixed values
2. Use of wrong of the calibrator.
calibrators 2. Use the calibrators correct. .
3. Wrong position of the 3. Check the position of
calibrator on the tube calibrators on the tube holder.
holder 4. Check to ensure sufficient
4. Calibrator is too low calibrators
5. Air bubbles in the 5. Prime the system and run the
detector and/or pump cleaning program.
system

44
 Chapter 9 Communication Protocol

9.1 Communication Protocol for sample results

The default baud rate is 19200、8data bit、No odd-even bit、1stop bit.

1、If users want to modify the baud rate, please go to “set up”—“communication” to change and then

restart the analyzer to valid the modification.

2、data transmission format:

<TRANSMIT><M>LD500|LD500-001<I>sample|2014-05-12
22:34:54|3105|10|1|10|0</I><R>HbA1ab|1.04HbA1c|7.19</R></M></TRANSMIT>

Field Description and meaning

<TRANSMIT> Message start symbol
</TRANSMIT> Message end symbol
Separator and tag of the instrument model name
<M>、|、</M>

LD500|LD500-001 Instrument model name and sequential number

Separator and tag of the sample information
<I>、|、</I>

Sample sample

0,1,2,3 0: Whole blood

1: Pre-diluted
2: QC mode
3: Calibration
2014-05-12 22:34:54 The time and date when each test finished.
3105|10|1|10|0 3105: Sequential No
10: sample ID
1: rack No
10: tube No
0: sample type
Separator and tag of the test results
<R>、|、</R>

HbA1ab:1.04 The test result of HbA1ab

HbA1c:7.19 The test result of HbA1c

45
9.2 Communication Protocol for QC results

if CanTransmint then
begin
SendOutStr('<TRANSMIT>');
SendOutStr('<M>');
SendOutStr('LD500|');
SendOutStr(gMachineSN);
SendOutStr('<Q>');

s:=ComboBox_Year.Text+'|'; //year
SendOutStr(s);
s:=ComboBox_Month.Text+'|'; //month
SendOutStr(s);

s:=ComboBox_LotNO.Text+'|'; //Lot No.

SendOutStr(s);

s:=IntToStr(ComboBox_QcLevel.ItemIndex)+'|'; //QC level(0=level1，1=level2，

2=level3，it can't be other value)

SendOutStr(s);

s:=StringGrid_QCFileInfo.Cells[1,1]+'|'; //average value

SendOutStr(s);

s:=StringGrid_QCFileInfo.Cells[1,2]+'|'; //SD
SendOutStr(s);

s:=StringGrid_QCFileInfo.Cells[1,3]+'|'; //CV
SendOutStr(s);

SendOutStr('</Q>');
;
for arow:=1 to StringGrid_QC.RowCount-1 do
begin
SendOutStr('<X>');
SendOutStr('date|');
s:=StringGrid_QC.Cells[0,arow]; //date
SendOutStr(s);

SendOutStr('HbA1c|');
46
 s:=StringGrid_QC.Cells[1,arow]; //A1C value
SendOutStr(s);

SendOutStr('NO|'); //No.
s:=StringGrid_QC.Cells[2,arow];
SendOutStr(s);

SendOutStr('</X>');
end;

SendOutStr('</M>');
SendOutStr('</TRANSMIT>');
end;

47
Manufacturer’s information

1F,W2-B Bldg, Keji 2nd Road South, Hi-Tech Industrial Park,Shenzhen,518057 ,P.R.C
LABNOVATION TECHNOLOGIES,INC.

Tel：+86 755-86368328，+86 755-86368398

Fax：+86 755-86368318
E-mail:[email protected]
http://www.labnovation.com/