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H100 Service Manual

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0% found this document useful (0 votes)
2K views129 pages

H100 Service Manual

Uploaded by

Ahmed Maaouia
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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H100 Service Manual

H100
Hemoglobin Analyzer (HPLC)

Service Manual

Customer Service
Prepared by
Department
Date 28 Feb. 2023

Document No.

Rev. A0 (2023. Feb. 28)


H100 Service Manual

Introduction

The Lifotronic H100 is manufactured according to rigorous quality


controls and, though it is a precision instrument, the failure of a
single part can jeopardize reliable results. Moreover, because it
is a high-end analyzer, usage trouble may affect measurement
results. If trouble of this kind occurs, take appropriate action to
remedy it as explained in this Service Manual and the User
Manual.

CAUTION !!

This Service Manual is prepared for service engineers who have completed special training.
Other persons should only use this as a reference. LIFOTRONIC assumes no responsibility
whatsoever for the instrument if serviced by unqualified persons. Moreover, any unauthorized
servicing shall forfeit any guarantees explicit or otherwise.
Contents H100 Service Manual

Contents
................................................................................................................................................................ 1
Chapter 1 Overview ......................................................................................................................... 6
1.1. Features ...................................................................................................................................6
1.2. Specifications .........................................................................................................................7
1.3. Assay Principal.......................................................................................................................8
1.4. Assay Appearance ............................................................................................................. 10
1.5. Common Spare part ......................................................................................................... 12
Chapter 2 Instrument Installation ..............................................................................................13
2.1. Instrument Installation ..................................................................................................... 13
2.2. Parameter adjustment ......................................................................................................28
2.3. Basic Performance Validation ........................................................................................ 28
Chapter 3 Instrument Operation ...............................................................................................30
3.1. Instrument Operation .......................................................................................................30
Chapter 4 Machinery .....................................................................................................................33
4.1. Appearance ..........................................................................................................................33
4.2. Module Introduction .........................................................................................................37
Chapter 5 Electric ........................................................................................................................... 42
5.1. Main control board........................................................................................................... 42
5.2. Interface board assembly ................................................................................................42
5.3. Detection board assembly..............................................................................................43
5.4. Driver board of auto sampler ........................................................................................ 43
Chapter 6 Liquid Flowing .............................................................................................................45
6.1. Sample test liquid line......................................................................................................45
6.2. Whole blood / anemia sample aspiration liquid line .............................................47
6.3. Diluted sample aspiration line .......................................................................................47
6.4. High-pressure pump cleaning line .............................................................................. 48
6.5. L reagent dispose .............................................................................................................. 48
Chapter 7 software .........................................................................................................................50
7.1. Start up ..................................................................................................................................50
7.2. Login ...................................................................................................................................... 50
Contents H100 Service Manual

7.3. Test ......................................................................................................................................... 51


7.4. Calibration ............................................................................................................................52
7.5. QC ...........................................................................................................................................53
7.6. Result ..................................................................................................................................... 54
7.7. Log..........................................................................................................................................56
7.8. System -> Maintenance ..................................................................................................68
7.9. System -> Settings............................................................................................................72
7.10. System -> Statistics ...................................................................................................... 74
7.11. System -> About ...........................................................................................................75
7.12. System -> Help ..............................................................................................................75
7.13. System -> Service ......................................................................................................... 75
7.14. System -> Service-> Pump and valve test ...........................................................75
7.15. System -> Service-> Motor test ..............................................................................75
7.16. System -> Service-> Optical sensor test .............................................................. 76
7.17. System -> Service-> 2D arm setting ..................................................................... 77
7.18. System -> Service-> Loader->Parameter ........................................................... 82
7.19. System -> Service-> Loader->Threshold............................................................ 90
7.20. System -> Service-> General Setting-> Parameter ......................................... 91
7.21. System -> Service-> General Setting-> Function .............................................92
7.22. System -> Service-> Performance Testing ..........................................................93
7.23. System -> Service-> User management .............................................................. 93
7.24. Software upgradation .................................................................................................. 94
7.25. Backup instrument data ............................................................................................100
7.26. Import instrument data.............................................................................................102
Chapter 8 Assembly .................................................................................................................... 104
8.1. Constant column heating module.............................................................................104
8.2. High-pressure pump assembly .................................................................................. 108
Chapter 9 Maintenance............................................................................................................. 112
9.1. Daily maintenance ...........................................................................................................112
9.2. Weekly maintenance...................................................................................................... 112
9.3. Monthly maintenance....................................................................................................113
9.4. Semestral maintenance................................................................................................. 115
Contents H100 Service Manual

Chapter 10 Trouble shooting...................................................................................................119


10.1. Pressure too high ........................................................................................................119
10.2. Pressure too low..........................................................................................................120
10.3. Error Code E1 ............................................................................................................... 122
10.4. Error Code E2 ............................................................................................................... 122
10.5. Error Code E3 ............................................................................................................... 122
10.6. Error Code E4 ............................................................................................................... 122
10.7. Error Code E5 ............................................................................................................... 122
10.8. Error Code E6 ............................................................................................................... 122
10.9. Error Code E7 ............................................................................................................... 122
10.10. Error Code E8 ............................................................................................................... 122
10.11. Error Code E9 ............................................................................................................... 123
10.12. Error Code E10 .............................................................................................................123
Chapter 11 Lis communication ................................................................................................124
B.1 LIS Communication Parameters ........................................................................................... 124
B.2 Communications Instructions ................................................................................................124
B.3 Sample Data Format.................................................................................................................125
Chapter 12 instrument packing...............................................................................................127
12.1. Drain liquid line ............................................................................................................127
12.2. Remove auto sampler ............................................................................................... 127
Chapter 1 Overview H100 Service Manual

Chapter 1 Overview
1.1. Features
96 seconds per sample measurement in the Variant mode, and 380 seconds in the
Thalassemia mode.
It takes 96 seconds to measure HbA1c and HbF and detect HbE/HbD/HbS/HbC (Variant mode).
Tests for HbA1c /HbF/HbA2 and HbE/HbD/HbS/HbC variants are completed in 380 seconds
(Thalassemia mode).
Measurements for up to 50 samples
The instrument can measure a maximum of 50 consecutive samples. During transporting the
samples racks, the auto sampler will mix the whole blood samples thoroughly for three times
before testing to make total area and results more stable and reliable.
Managing column/reagent information
By scanning column/reagent Bard code or entering the serial numbers, you can store the
expiration dates and lot numbers of the column/reagents (eluents, hemolysis washing solution,
calibrator and QC) in the instrument. An error message appears on the screen if you try to enter
an incorrect or invalid bar code.
Easy to use
Priming before measurements is automated, so no action is needed from the time when power is
activated to the time when measurements start. A large color LCD makes measurement
conditions and menu settings easy to read and identify, which makes operation easy.
Measurement results, instrument status and operating procedures are displayed, while the
remaining volume of reagent is shown on electronic graphs.
Chromatograms can also be viewed along with measurement results.
Highly accurate measurement results
Measurements are performed by high performance liquid chromatography (HPLC), a technique
that provides accurate data on HbA1c. A pre-column and column is used to remove labile HbA1c.
Stable HbA1c values, HbF values and chromatograms can be obtained.
Test mode switching
The instrument allows the switch between Variant and Thalassemia programs via a software command
resulting in the automatic replacement of eluent C (Variant mode) with eluent D (Thalassemia mode) in
the liquid line and vice versa.
Easy maintenance
Daily maintenance can usually be performed without tools as parts can be easily replaced and
tightened by hand. In addition, the prefilter is incorporated into the pre-column, removing the
need for prefilter replacement.
On-the-spot STAT measurement
A port specifically for STAT measurements is provided. So normal measurements can be
interrupted to measure one specific sample. STAT measurement can also be performed while the
standby screen is displayed.
Fluid level detection sensor to prevent reagent shortages during measurement
Reagent levels can be measured and when low levels are detected, messages shall be displayed
on screen to notify the user. Two reagent containers for each eluent are designed, in order to
allow the substitution of the empty container without interrupting the measurement routine.
LIS communications
The analyzer can be fully interfaced to laboratory IT (RS-232, RJ45 Ethernet).
Wide array of options available
Lifotronic makes available a wide array of options including hand-held barcode readers, and a
side sampler.
Chapter 1 Overview H100 Service Manual

1.2. Specifications
Instrument specifications
Product H100
Configuration Main body, auto sampler (with sample tube mixing unit) and
accessories
Measurement objects Whole blood or hemolysis sample
Column H100 analytical column
Reagents H100 eluent A, H100 eluent B, H100 eluent C, H100 eluent D,
H100 hemolysis solution L
Measurement items HbA1c and HbF, HbE/ HbD/ HbS/ HbC variants can be detected in
Variant mode.
HbA1c, HbF and HbA2, HbE/ HbD/ HbS/ HbC variants can be
detected and reported in Thalassemia mode.
Quantitative range HbA1c: 3 - 20%, 9 - 195 mmol/mol
HbF: 0 - 100%
Measurement principle Reversed-phase cation exchange chromatography
Measurement wavelength 415 nm/500 nm (Dual-wavelength colorimetry)
Sample supply Auto Sampler
Resolution 0.01% or 0.1% Ratio, 0.1mmol/mol
Processing speed Variant mode: 96 seconds/test
Thalassemia mode: 380 seconds/test
Sample consumption Whole blood samples: 5-10 µL
Pre-hemolyzed samples: 200-500 µL
Required sample volume Sample tube: 1 mL in standard whole blood containers Sample
cup: 500 μL or more
Sample container Whole blood sample tube: (12.3-15 mm diameter) × (75-100 mm
height)
Mixing function only with tubes of regular size: (12.3-13.2 mm
diameter) × (75-85 mm height), with software option to process
tubes without mixing function if necessary.
Compatible rack type Lifotronic racks
Number of measurement Maximum 50 samples
samples
Column temperature 25~40°C,35°C as default
Warm-up time <5 minutes from standby
Display Large color LCD with backlight
Printer For use with 58-mm width thermal printer paper
Memory capacity 10000 measurement results (including calibration results)
External output Serial port and Ethernet port
Operating environment Temperature: 10 - 30°C; Humidity: 20 - 80% RH (No condensation)
Measurement environment Temperature: 10 - 30°C; Humidity: 20 - 80% RH (No condensation)
Storage environment Temperature: 0 - 55°C; Humidity: 0 - 93% RH (No condensation)
Environment during transport Temperature: 0 -55°C; Humidity: 0 - 93% RH (No condensation)
Dimensions 450 (W) × 361 (D) × 540 (H) mm
(Not including the hemolysis washing solution bottle)
Net Weight Approximately 55 kg
Power requirements 100 - 240 V AC ± 10%, 50/60 Hz
Power input Maximum 200 VA
Sound pressure level Less than 80 dB
Location of use For indoor use only
Altitude Up to 2000 m
Pollution degree 2
Over voltage category II
Expected life 5 years (According to company data)
Chapter 1 Overview H100 Service Manual

1.3. Assay Principal


1.3.1. Overview

In human blood, there are three kinds of hemoglobin (Hb): hemoglobin A (HbA),
hemoglobin A2 (HbA2) and hemoglobin F (HbF).
For adult, the level of HbA consists 97% of total hemoglobin, and HbA includes
2 subfractions: glycosylated hemoglobin (HbA1)(6%), un-glycosylated
hemoglobin (HbA0)(94%).
Glycosylated hemoglobin is a compound that is formed in the non-enzymatic
reaction between hemoglobin and carbohydrate. Glycosylated hemoglobin is
called HbA1 and un-glycosylated hemoglobin is called HbA0.On the basis of
combination with different carbohydrate compound, glycosylated hemoglobin is
divided into HbA1a1、HbA1a2、HbA1b and HbA1c. Among of which, HbA1c is
about 80% of HbA1, a stable addition compound formed by one or two strips of
β-chain amino terminal and glucose carbonyl.
See constituent of hemoglobin below.

Picture 1-1 Constituent of Hemoglobin


Synthesis process of HbA1c is slow and irreversible. And it accumulates in the
120 days lifetime of erythrocytes. The synthesis rate is proportional to the
concentration of blood glucose and its structure is stable. Therefore, the level of
HbA1c reflects the average level of blood glucose in the past 2-3 months. As the
average amount of blood glucose increases, the fraction of glycated hemoglobin
increases in a predictable way, which is not related to blood drawing time,
whether it is fast or not and whether use insulin or not. It’s a reliable marker to
indicate the control of blood glucose levels.
H100 Hemoglobin Analyzer adopts Liquid chromatographic method to
measure the level of HbA1a, HbA1b, LA1c, HbA1c ,HbA0 and HbA2.
Chapter 1 Overview H100 Service Manual

1.3.2. Measurement

1.3.2.1. Iron exchange

The glycosylation of hemoglobin will lose cation on hemoglobin surface. The


ion concentration increases and (or) pH decreases in weak cation-exchanger.
When passing through cation-exchange column, the hemoglobin will be absorbed
by resin which was balanced by acidic buffer. Since the charges of different
glycosylated hemoglobin and un-glycosylated hemoglobin, absorbing forces will
be different. The less cation of glycosylated hemoglobin means the less
absorbing force. On the contrary, the cation level of un-glycosylated hemoglobin
is high. Elute that glycosylated hemoglobin with different buffer solutions in
sequence, as HbA1a, HbA1b, HbA1c. The strongest absorbing force of HbA0 and
HbA2 will be eluted in the end.

1.3.2.2. Colorimetric Analysis Principle

According to Lambert-Beer law, when a collimated monochromatic light transit


a even solution medium, part of this light will be absorbed and the other part will
be reflected by container. Define the incident light intensity as I0, the transmission
light intensity as It, the solution concentration as c, and the thickness of liquid as b.
See the absorbing schematic diagram below.

Picture 1-2 Absorbing Schematic Diagram


Written as:

I0
lg
A = kbc= It

In the equation above, A means absorbance; K is absorption coefficient. The


equation means that the absorbance of solution is in direct proportion to the
product of solution concentration and liquid thickness.
The absorption peak wavelength of glycosylated hemoglobin is 415nm. So
when 415 nm LED light passes through a cuvette, it will be absorbed by photocell
Chapter 1 Overview H100 Service Manual

after passing through a 415nm band pass filter. Light intensity is proportion to the
converted potential. See the schematic diagram below.

Picture 1-3 Colorimetric Analysis Principle


Therefore, absorbance could be also written as:

I0 E0
lg lg
A= It = Et

In the equation above, E0 means incident light potential; Et means


transmission light potential.
Through amplifying and acquiring photocell signal by computer, measure
real-time absorbance of the eluates continuously.

1.4. Assay Appearance

1.Touch Screen

4.Auto Sampler

Picture 1-4 Front Appearance


Chapter 1 Overview H100 Service Manual

2.Card Swiping Area

4.Auto Sampler

Picture 1-5 Left Appearance

3.Thermal Printer

4.Auto Sampler

Picture 1-6 Left Appearance


1. Touch screen
Chapter 1 Overview H100 Service Manual

The touch screen is in the front of the main unit of the analyzer. The analyzer
uses a 10.1-inch capacitive screen for interface operation and information
display.

 Do not use any sharp objects or apply too much force on the touch screen.
 Use a clean, soft cloth to clean the touch screen; neutral cleanser or alcohol is
recommended. It is forbidden to use chemical solvents or acid and alkali liquids.

2. Card Swiping Area


The Card swiping area is used to replace the chromatographic Column.

3. Thermal Printer
The thermal printer is used to print results of sample tests, fault information,
device parameters, etc.

4. Auto Sampler
The auto sampler is used to loading the sample rack and unloading the sample
for the apparatus.

1.5. Common Spare part

1.5.1. Chromatographic Column

Cation exchange resin inside the Chromatographic Column can adsorb


glycated and other hemoglobin molecules. As the ion concentration of the eluent
increases, the glycated hemoglobin HbA1a and HbA1b, fetal hemoglobin HbF,
unstable glycated hemoglobin LA1c, stable glycated hemoglobin HbA1c and
non-glycated hemoglobin HbA0 and HbA2 are eluted off, respectively.

1.5.2. In-line Filter

The In-line filter is used to intercept the filtrate lumps or floccules in blood
samples, protect and prolong the life of chromatographic column.
Chapter 2 Instrument Installation H100 Service Manual

Chapter 2 Instrument Installation


2.1. Instrument Installation
2.1.1. Product Composition

This analyzer mainly consists of a main unit, a sample introduction system,


Chromatographic Column, filters, and an analysis system.
The main unit mainly consists of a liquid chromatography separation system, a
liquid chromatography detection system, a mechanical system and a hardware
and software system.
The packing list of the analyzer is shown below, subject to the actual packing
list.

Classification No. Name Quantity Unit


Entire analyzer 1 Main unit 1 EA
2 Sample Loader 1 PCS
3 Sample Rack 5 PCS
4 Calibration Rack 1 PCS
5 QC Rack 1 PCS
6 Anemia Rack 1 PCS
7 Calibration Rack Label 6 PCS
8 QC Rack Label 6 PCS
9 Sample Rack Label 30 PCS
10 Anemia Rack Label 6 PCS
11 Diluted Sample Holder 10 PCS
12 10L Waste Bottle 1 PCS
Standard
13 Liquid Path Accessory 1 PCS
configuration
14 Power Cord 1 PCS
15 Barcode Scanner 1 PCS
16 Spanner(8-10) 2 PCS
17 Spanner(1/4) 1 PCS
18 Spanner(φ3mm) 1 PCS
19 Thermal Paper 1 PCS
20 Fuse Protector 2 PCS
21 Pan Head Screw M6*20mm 4 PCS
22 Reagent Tray 1 PCS
23 User Manual 1 PCS
24 Operation Guide 1 PCS
Chapter 2 Instrument Installation H100 Service Manual

2.1.2. Installation Environment Requirement

● Please store and use the analyzer under specified environmental conditions.
● If the room temperature is beyond the range of normal operating temperature
for the analyzer, the analysis result obtained will be unreliable.

Operating conditions Storage conditions


Ambient temperature 10℃~30℃ 0℃~55℃
Relative humidity ≤80% (non-condensing) ≤93%
Atmospheric pressure 75kPa~106kPa 75kPa~106kPa

 The ambient environment should be free from dust, mechanical vibration,


pollution, noise sources and power interference.
 Evaluate the electromagnetic field in the laboratory before running the analyzer.
 Keep the analyzer away from sources of strong electromagnetic field to ensure
optimal performance.
 Do not place the analyzer near brush type motors, flashing fluorescent lights and
electrical equipment that is frequently turned on and off.
 Avoid direct exposure to strong light and keep the analyzer away from sources of
heat and wind.
 Keep the analyzer at a well-ventilated place.
 Do not place the analyzer on an inclined plane.
 Good grounding should be available.
 Indoor use.

2.1.3. Installation Step

● The sampling needle is sharp. Bio-contaminated blood samples may remain on


the sample compartment, sampling needle, Chromatographic Column and filter. The
operator should wear gloves during installation to avoid direct contact with the above
components.
● The operator’s clothes, hair and hands must be kept at a safe distance from the
sampling needle, 2D arms and other moving parts to prevent injury.

2.1.3.1. Install the auto sampler


Chapter 2 Instrument Installation H100 Service Manual

1. Remove the screws of auto sampler’s front cover and STAT protective

cover (5 screws)

2. Remove the ribbon of auto sampler’s shaker

3. Press auto sampler’s back side fixture screws, and remove auto

sampler’s front cover

4. Remove 4 screws which fixed inside of auto sampler


Chapter 2 Instrument Installation H100 Service Manual

5. Install auto sampler into instrument and plug the wire

6. Install back the front cover and STAT position protective cover

2.1.3.2. Removal of Metal Slice Fixing the 2D arm

In order to avoid damage of the 2D arm during transportation, a metal slice is


used to fix the 2D arm before delivery. Prior to use, the metal slice must be
removed following the steps below:
1. Open the right door, as shown in Picture 2-1:
Chapter 2 Instrument Installation H100 Service Manual

Metal Slice

Picture 2-1 View after Opening the Right Door


2. Use a screwdriver to unscrew the two screws that fixed the 2D arm to the
metal slice, and then, remove the metal slice.

Metal Slice

Picture 4-2 View of the Metal Slice and Fixed 2D Arm


Chapter 2 Instrument Installation H100 Service Manual

2.1.3.3. Reagent Connection

Insert bottle cap components to eluents A, B, C and D respectively, then tighten


the cap firmly on the instrument back side, as shown in Picture 4-3.

2. Hemolytic Agent L
Connector
1. Eluent A/B/C/D
Connector

3. Waste Liquid
Sensor & Liquid
Connector

Picture 4-3 View of Eluent A, B, C, D, Hemolytic Agent L and Waste liquid

● Reagents may irritate eyes, skin and mucosa. When contacting reagent-related
materials in the laboratory, the operator should comply with the requirements for safe
operation in the laboratory and wear personal protective equipment (e.g., laboratory
protective clothing and gloves).
● If your skin comes into contact with any reagent, flush immediately with plenty of
water, and seek advice from a doctor if necessary. If in eye, please flush immediately
with plenty of water, and seek advice from a doctor.

● DO NOT mix different batches of reagents together.


● Ensure that the reagent and Chromatographic Column are used within shelf life.
Chapter 2 Instrument Installation H100 Service Manual

● After the reagent is connected to the analyzer, firmly cap the reagent bottle to
prevent contamination of the reagent.

Take the Hemolytic Agent L connecting component from the accessories;


connect one end to the hemolysis reagent connector on the back of the analyzer (as
shown in Picture 4-3) and insert the other end into the Hemolytic Agent L bucket.
Take the waste liquid connecting component from the accessories; connect one
end to the waste liquid connector on the back of the analyzer (as shown in Picture
4-3) and insert the other end into the waste liquid bucket.

● Two modes are available for connection of waste liquid: use of waste liquid
bucket, or direct discharge.
● Ensure that the waste liquid bucket is placed at a height not above the surface
where the analyzer is placed. If direct discharge of waste liquid is selected, make
sure the position of waste liquid pipe is below the waste liquid outlet of the
analyzer.
Chapter 2 Instrument Installation H100 Service Manual

2.1.3.4. Installation of In-line filter

1) Take the filter out of the packaging box, rotate the handle and pull out the filter
bracket, then take off the old filter, put in the new filter. Make sure that the liquid
delivery direction of the filter. Then, insert the filter bracket back. Finally, tighten
the handle.

Handle

Filter Bracket

Fig 2-4 The Liquid Delivery Direction of the Filter


2) Enter the “Test” interface, press the “Filter” icon, a prompt will show up as Picture
2-5.

Picture 2-5 View of Filter Installation Procedure (1)


Chapter 2 Instrument Installation H100 Service Manual

3) Press “Replace”, a prompt will show up as Picture 2-6.

Picture 2-6 View of Filter Installation Procedure (2)


4) Waiting about 10 minutes, the replacement process is completed.

2.1.3.5. Installation of Chromatographic Column

Before installing the Chromatographic Column, please read relevant chapters in


the instructions, and then follow the steps below:

1) Take the Chromatographic Column out of the packaging box, and remove the
retaining plugs connected at both ends of the column. Please keep the retaining
plugs properly for future use. Open the chromatographic Column oven after
confirming that the analyzer has stopped delivering liquid, take off the plastic
hose which both sides are connected to the plugs and connect the both sides of
the chromatographic Column with the plugs. Make sure that the liquid delivery
direction of the chromatographic Column (the arrow direction indicated on the
label attached to the chromatographic Column) is consistent with the label on the
column oven, then tighten the plugs on both sides and close the chromatographic
oven.
Chapter 2 Instrument Installation H100 Service Manual

Liquid flow direction

Chromatographic
Column

Picture 2-7 the Liquid Delivery Direction of the Chromatographic Column


2) Enter the “Test” interface, press the “Column” icon, a prompt will show as Picture
2-7 below. Press “Replace”, a prompt will show as Picture 2-8.

Picture 2-8 View of Chromatographic Column Installation Procedure (1)


Chapter 2 Instrument Installation H100 Service Manual

Picture 2-9 View of Chromatographic Column Installation Procedure (2)


3) Take the card out of the packaging box and swipe the card on the left side of the
analyzer to read the new serial number. A prompt will show as Picture 2-10. Then
press “Yes”. You also could enter the serial number of the new column which is
attached to the packaging box, and press “Yes”. A prompt will show as Picture
2-11.

Picture 2-10 View of Chromatographic Column Installation Procedure (3)


4) Input the temperature attached to the column, press “Yes” and a prompt will show
as Picture 2-11.
Chapter 2 Instrument Installation H100 Service Manual

Picture 2-11 View of Chromatographic Column Installation Procedure (4)

Picture 2-12 View of Chromatographic Column Installation Procedure (5)


5) To complete column installation procedure, two protocols are possible.
Protocol A:
Step 1: Place 40 µL of WB in a 1.5 EP tube,
Step 2: Place the tube in the STAT port,
Step 3: Prompt will show as Fig. 4-8, click “Yes” to dispense 600 µL of
solution H through the analyzer, a prompt will show as Fig. 4-9,
Step 4: Mix manually,
Step 5: Click NEXT,
Chapter 2 Instrument Installation H100 Service Manual

The chromatographic Column has been successfully installed.

Protocol B:
Step 1: Prepare an EP tube with 40 µL of WB+600 µL of solution H, mix,
Step 2: Place the tube in the STAT port,
Step 3: Prompt will show as Fig. 4-8, click NEXT,
The chromatographic Column has been successfully installed.

Picture 2-13 View of Chromatographic Column Installation Procedure (6)

2.1.3.6. Installation of paper

Pull the printer lever outward to open the printer door. Load recording paper into
the paper cavity in the direction shown in Picture 2-14, with the paper end positioned
outside the paper outlet. Close the printer door; check the position of recording paper
to ensure that the recording paper is aligned with the paper outlet.

Recording Paper

Picture 2-14 Loading of Recording Paper


Chapter 2 Instrument Installation H100 Service Manual

2.1.3.7. Installation of the Power Cord

Take the power cord form the accessory package, insert one end of the power
cord into the power input port on the back of the analyzer, and the other end into the
power outlet

2.1.4. Initial startup


Switch on the power switch on the back of the analyzer. The system will enter the
login interface (Picture 2-15). Enter the account password and choose the Variant or
Thalassemia mode, then press “Login”, the analyzer will automatically execute
self-check and system cleaning process, and then enters the test interface (Picture
2-16).

Picture 2-15 View of Login Interface


Chapter 2 Instrument Installation H100 Service Manual

Picture 2-16 View of Test Interface

In the test interface, the remaining volumes of the eluent A/B/C/D and
Hemolytic Agent L, the number of available tests of the Chromatographic Column and
the filter are displayed.

 Number of Tests per Chromatographic Column

Chromatographic Column are consumable materials; the number of available


tests is 3000 tests (not including calibration analysis). Every time a sample is
analyzed, the available test number of the Chromatographic Column automatically
decreases by one. If the number of available tests by the Chromatographic Column
reaches the lower limit, the Chromatographic Column should be replaced by a new
one. Otherwise, the test cannot be started.

 Number of Tests per Filter

Filters are consumable materials; the number of available test are 800 tests (not
including calibration analysis). Every time a sample is analyzed, the available test
number of the filter automatically decreases by one. If the number of available tests by
the filter reaches lower limit, the filter should be replaced. Otherwise, the test cannot
be started.

Press “System” to enter the system interface:

Picture 2-17 View of the System Interface

Press “Prime Liquid Line” and wait, when the priming process is completed,
Chapter 2 Instrument Installation H100 Service Manual

Press “Bubble Elimination” to eliminate air bubbles in the high pressure pump. In
case of other malfunctions during operation, please see “Chapter 11 Trouble
shooting” in this manual.
2.2. Parameter adjustment
2.2.1. Auto sampler adjustment

Please check chapter 7 software for adjust auto sampler

2.2.2. Probe adjustment

Please check chapter 7 software for adjust Probe

2.2.3. Mixing compartment adjustment

Please check chapter 7 software for mixing compartment

2.3. Basic Performance Validation

2.3.1. Calibration and QC test

The operation of the calibration and QC operation, please go to H100 user


manual’s Chapter 8 Quality Control and Chapter 9 analyzer calibration.

For calibration test, the valid range of the calibration factor K should be in range:
0.8000~1.2000 and the factor B should be in range: -2.0000~2.0000.

For QC test, the operator should follow QC’s Westgard rules to operate daily
quality control test.

2.3.2. TP valve

TP: Theoretical plate


Function: TP value is to indicate the theoretical plate of the column by calculating
the target peak to show the column efficiency.
Meaning: The theoretical plate depends on the type and nature of the column
stationary phase, like particle size and its distribution, column length, column type,
flow rate. To analyze the column efficiency during the test of the device, it is monitored
the target peak by calculating its peak sharpness, symmetry, height, whether the
elution is complete, etc. which will help the user understand more about the column
state and column efficiency during the tests. The acceptable range is from 30-100.

2.3.3. Chromatographic checking


Chapter 2 Instrument Installation H100 Service Manual

The operator can check the chromatographic in instrument’s result interface. The
message on the Picture 2-18 is displayed as below.

Picture 2-18 Details of Single Sample Result Interface


Click on the chromatogram area to enlarge it and the full chromatogram of the
selected sample will be displayed.

About the detection of variants

The analyzer can detect 4 kinds of variants, including HbE, HbD, HbS, HbC.
When a variant is detected, the result is shown in the “ V_Win ” line and the result of
HbA1c will be marked with * and marked red. It is recommended that the operator
combine with other indicators to make judgments. Example of variant detected is as
e.g. Picture 2-20 Test Result of Variants.

Picture 2-20 Test Result of Variants


Chapter 3 Instrument Operation H100 Service Manual

Chapter 3 Instrument Operation


3.1. Instrument Operation
3.1.1. Overview

This chapter introduces the whole process of routine operations from start up to
shutdown of the analyzer, and especially focuses on the operation process of analysis
of whole blood sample and diluted blood sample.
Below is the process of routine operations:

Preparation before
operation

Power-on
self-test/cleaning

QC analysis

Sample preparation Activation

Sample analysis

Standby

Shutdown

Sleep

3.1.2. Instrument Status List

3.1.3. Review of Results

This system allows review of analysis results in the form of list; 10 samples are
listed on each page. Click the “Result” button on the menu interface below to enter
the list result query interface.
In the top left of Result interface, click the "Result" option, you could review the
Chapter 3 Instrument Operation H100 Service Manual

Variant or Thalassemia mode analysis results by choose.

Picture 3-1 Result Interface

Key Functions

: Return to result interface

: Display the previous page

: Display the next page

: Display the last page

: Delete the selected result

: Delete all results

: Print the selected result

: Display the details of selected sample result

: Export sample results to U-disk


Chapter 3 Instrument Operation H100 Service Manual

Display content

1.Number Test SN
2.Sample No. Sample ID
3.Type Sample type
4.Date and time Analysis time
5.HbF(%) HbF ratio
6.HbA1c(%) HbA1c ratio
7.HbA2 (%) HbA2 ratio (in 380s Result)
8.Remark Remark

The operator can click “Previous” or “Next” button to review analysis results in
the form of list. Data shown in the list includes sample SN, sample ID, sample type,
analysis date, analysis time, HbF ratio, HbA1c ratio, HbA2 ratio, and remark. After
selecting a result entry, click for Details. Also, the system allows query of results by
sample ID and date.
During the testing, only the results of the current page are allowed to be viewed,
and no other actions are allowed.

About the explanation of abnormal results

If the test results are abnormal, the “Remark “column will display the corresponding
code (e1 ~ e10).

The meaning of the codes can check “Chapter 7 Software”


.
Chapter 4 Machinery H100 Service Manual

Chapter 4 Machinery
4.1. Appearance
4.1.1. Front Appearance

In-line filter
2D arm assembly

Six-way
valve
Post filter

Constant column
Evacuation valve
heating module

SATA position
Sample unloading
side Sample loading
side

Auto sampler

1. In-line filter, “In-line filter” is used to prevent the sediment of liquid flow into the
column to affect the chromatographic.
2. Six-way valve, it is the connection of sampling pipeline and test pipeline, it is
helping the instrument transfer the sample from sampling pipeline into test
pipeline.
3. Constant column heating module, provide a stable working environment for
column.
4. Sample unloading side, the instrument will be unloading sample rack which is
finished sample test in this side of “Auto sampler”.
5. Auto sampler, the place where the operator placed and taken the sample rack.
6. Sample loading side, the place where the operator places the sample rack on
“Auto sampler”.
7. SATS position, the place of where operator place the sample which need
emergency test.
8. Evacuation valve, it is used to help instrument create the pressure to test
sample.
9. Post filter, it is used to prevent the sediment of the liquid flow into “wasted pump”.
10. 2D arm assembly, it will carry puncture probe moving in “STAT position”, whole
blood tube, and “diluted tank”.
Chapter 4 Machinery H100 Service Manual

4.1.2. Back Appearance

RS232 port

Power switch
Network port

USB port
Power input
port
Eluent A,B,C,D

Hemolytic agent
L connector
Sampler loading side

Sampler unloading

Auto sampler

Waste liquid
sensor &
liquid
1. RS232 port, “RS232 port” is the place where connect with RS-232 wire.
2. Network port, the network port can be used for online debugging, and the
networking function of LIS/HIS system.
3. USB port, the double-layer USB port can be used for upgrade of system
application and external connection with USB scanner gun, mouse, keyboard,
laser printer, etc.
4. Eluent A,B,C,D, for connection with eluent A/B/C/D.
5. Sample loading side, the place where the operator places the sample rack on
“Auto sampler”.
6. Auto sampler, the place where the operator placed and taken the sample rack.
7. Waste liquid sensor & liquid, it is used to connect with external 10L waste liquid
bottle and sensor.
8. Hemolytic agent L connector, it is connected with external 5L hemolytic L bottle
and the sensor.
9. Power input port, this is the place where connect the power wire.
10. Power switch, it is controlling the power of the instrument.
Chapter 4 Machinery H100 Service Manual

4.1.3. Left Appearance

Main control board

Six-way
valve
Touching
screen
Constant column
heating module

Card swiping area

100uL
plunger pump Sampler
unloading side

High-pressure
Auto
pump assembly
sampler

1. 100uL plunger pump, it is used to add the whole blood sample into test liquid
line.
2. High-pressure pump assembly, this is the main power source of test pipeline.
3. Auto sampler, the place where the operator placed and taken the sample rack.
4. Sample unloading side, the instrument will be unloading sample rack which is
finished sample test in this side of “Auto sampler”.
5. Card swiping area, this is the place where swap the RFID card.
6. Constant column heating module, provide a stable working environment for
column.
7. Touching screen, the operator can control instrument and monitor the test result
from this screen.
8. Six-way valve, it is the connection of sampling pipeline and test pipeline, it is
helping the instrument transfer the sample from sampling pipeline into test
pipeline.
9. Main control board, this is the electric board used to control and analyze
hardware and analog signal.
Chapter 4 Machinery H100 Service Manual

4.1.4. Right Appearance

Main control board

Touching
screen

2D arm assembly
SATA position Diluted tank

Two-way valve

Sampler 5mL plunger pump


loading side
Degasser

Waste filter
Auto
Wasted pump
sampler

1. Touching screen, the operator can control instrument and monitor the test result
from this screen.
2. SATS position, the place of where operator place the sample which need
emergency test.
3. Sample unloading side, the instrument will be unloading sample rack which is
finished sample test in this side of “Auto sampler”.
4. Auto sampler, the place where the operator placed and taken the sample rack.
5. Wasted pump, it is the main power source to pipe out the wasted reagent.
6. Waste filter: it is the filter to clean the sediment to prevent damage the waste
pump.
7. Degasser, this is the spare part to eliminate the air bubble of the reagent.
8. 5mL plunger pump, aspirate the sample into test pipeline to analyze the sample.
9. Two-way valve, this is the spare part to control the liquid flowing direction
10. Diluted tank, the instrument will dilute the whole blood sample in this place, to
broken RBC.
11. 2D arm assembly, it will carry puncture probe moving in “STAT position”, whole
blood tube, and “diluted tank”.
Chapter 4 Machinery H100 Service Manual

12. Main control board, this is the electric board used to control and analyze
hardware and analog signal.

4.2. Module Introduction

4.2.1. Auto sampler


Barcode
Rack detection sensor
Tube collector scanner
Rack shift-in device
Tube mixer
Rack belt STAT position
Rack shift
out
Motor driver
device

Driver board

Auto sampler is used to loading and unload the sample from instrument

1. Rack shift out device: this is “auto sampler’s” part to collect the sample rack
which is done the sample test.

2. Rack belt: this is “auto sampler’s” part to load and unload the sampler in and
out of instrument.

3. Tube mixer: this is “auto sampler’s” part to mix the whole blood sample before
start the sample test.

4. Tube collector: this is “auto sampler’s” part to remove the probe with whole
blood tube while instrument finished collect the sample.

5. Barcode scanner: this is “auto sampler’s” part to scan the bar code of sample.

6. Rack detect sensor: this is “auto sampler’s” part to detect whether have
sample rack in “auto sampler’s” sample loading side.

7. Rack shift-in device: this is “auto sampler’s” part to sent the sample rack into
“rack belt”.

8. STAT position: this is “auto sampler’s” part to place emergency sample.

9. Motor driver: this is “auto sampler’s” part to drive the motor of “auto sampler”
movement.

10. Driver board: this is “auto sampler’s” part to control all the movement of “auto
sampler”.
Chapter 4 Machinery H100 Service Manual

4.2.2. 2D arm Assembly

Z Axis zero Drag chain


optocoupler

Z Axis slider Z Axis motor

X Axis zero
optocoupler
Puncture
X Axis driving
sample probe
wheel

X Axis belt
Swab

2D arm assembly is used to aspirate the whole blood sample and transfer the diluted
sample inside of the instrument. On 2D arm assembly, there is a puncture probe used to
aspirate the whole blood and diluted sample into the instrument analyze pipeline.

1. Z Axis zero optocoupler, this is the sensor tell the “2D arm assembly” where is
the original Z axis arm position.

2. Z Axis slider, it is the part of Z axis.

3. Puncture sample probe, this is the spare part that instrument aspirate the
sample, it is used to aspirate the whole blood sample and diluted sample into
instrument pipeline to analyze the sample.

4. Z Axis motor, this motor is the power source of 2D arm working in Z axis.

5. X Axis zero optocoupler, this is the sensor tell the “2D arm assembly” where is
the original X axis arm position.

6. X Axis driving wheel, it is the spare part help the X axis transfer the power which
generated by motor into 2D arm to let the 2D arm moving in X axis direction.

7. X Axis belt, it is the spare part help the X axis transfer the power which generated
by motor into 2D arm to let the 2D arm moving in X axis direction.

4.2.3. Six-way valve

Six-way valve is used to help instrument transfer the diluted sample into test pipeline,
this spare part served as transfer sample.
Chapter 4 Machinery H100 Service Manual

1. Rotor: it is the spare part to switch the status of “six-way valve” status.

2. Stator: it is the part to fix the rotor with “six-way valve”

4.2.4. Constant column heating module

Flow cell

Pre-heating tube

Heat sink

Constant column heating module is used to keep the column working in constant
temperature, and colorimetric analysis principle will happen in here to analyze the sample.

1. Flow cell, the detect sample will be pass through in here

2. Pre- heating tube, it is helping the instrument keep column working in stable
temperature environment.

3. Heating sink, it is helping the instrument keep column working in stable


Chapter 4 Machinery H100 Service Manual

temperature environment.

4.2.5. Degasser

Degasser is used to eliminate the bubble of the pipeline; it is the spare part help to
make sure the chromatographic stable.

4.2.6. High-Pressure pump

One-way Pre-filter
assembly

High-pressure
pump head

High-pressure pump is used to provide constant, stable liquid flow in instrument


pipeline, to help instrument analyze the sample.

1. High-pressure pump head, it is helping the instrument creating a closed space


to pipe out the reagent into test pipeline.

2. One way assembly, it is let the liquid flow in one direction.

3. Pre-filter, this is the spare part prevent the sediment of the reagent get into test
Chapter 4 Machinery H100 Service Manual

pipeline.
Chapter 5 Electronics H100 Service Manual

Chapter 5 Electric
5.1. Main control board
Main control board is used to control the motor of the instrument, analyze the
analog signal from detection board and analyze the chromate graphic to give the
result of the sample

UART for MCU Optical sensor


Driver Driver MPU
Negative Plunger board board Jtag for Solenoid Backup
and waste pump sensor valve MCU valve Printer signal
pump and power
supply
Coil cell battery
Waste
liquid
Backup for
sensor
Backup for RFID
Interface
board Touch

LCD
Core control
board Micro SD

Power supply Six-way valve

Speaker
Auto sampler
power supply Backup

Led and detector


Backup

Fan
Auto sampler
signal Barcode Peltier Z axis High Backup High pressure
Negative
scanner motor Pressure sensor
Pressure
pump Ambient
Z axis X axis
temerature
optocoupler motor

5.2. Interface board assembly


Interface board assembly is used to build up the communication of RS-232,
Lan wire and USB port with main control board
Chapter 5 Electronics H100 Service Manual

To main
RS-232 Serial Port Ethernet port USB Port control board

5.3. Detection board assembly


Detection board assembly is used to detect the changes of sample, to give
the board analog signal

To main board J25

5.4. Driver board of auto sampler


Driver board of auto sampler is used to control the movement of the auto
sampler
Chapter 5 Electronics H100 Service Manual

Barcode Mixing up and


STAT unit VR4 Mixing unit
scanner down unit

Assembly
line power
supply
VR3
Power
supply

Backup

Backup
CAN bus

CAN bus
With main
board

VR1 Motor Backup


VR2 Sample
Loading unit driver
delivery
Clamping
optocoupler
unit
Chapter 6 Liquid Flowing H100 Service Manual

Chapter 6 Liquid Flowing


6.1. Sample test liquid line
The instrument will input eluent A, B, C and D passthrough degasser to eliminate
bubbles of eluent.

Valve
Pressure
Sensor
Degasser

Eluent

After eliminate the bubble of eluent, instrument will sent eluent into High-pressure
pump.

Six-way valve

Valve 19~22

High-pressure pump assembly

High pressure pump will pipe the eluent into six-way valve (Inject) and sent the
sample into test compartment. The flow direction is, from High-pressure pump ->
sample ring -> In-line filter.

High-pressure pump In-line filter

Sample ring

5mL plunger pump


Sample probe

After the instrument pipe the eluent into six-way valve, the reagent will pipe out from
Chapter 6 Liquid Flowing H100 Service Manual

six-way valve No.2 position and get into in-line filter. Then the eluent will flow into test
liquid line with sample by the power create by high-pressure pump. The eluent flowing
direction is from In-line filter -> pre-heating tube -> column -> detector.

Six-way valve No.2


connector

Diluted tank

After the eluent passed through Boost pressure tube, will flow into diluted tank. The
eluent flow direction is: diluted tank -> bottom wasted filter -> wasted pump -> wasted
tank.

Boost
pressure tube
SV 6

High-pressure
pump
Chapter 6 Liquid Flowing H100 Service Manual

6.2. Whole blood / anemia sample aspiration liquid line

The instrument will use 100uL plunger pump to aspirate whole blood sample and
diluted the sample in diluted tank. The flow direction is whole blood tube -> puncture probe
-> 100uL plunger pump -> puncture probe -> diluted tank.

High-pressure pump In-line filter

Sample ring

5mL plunger pump


Sample probe

After the instrument diluted the sample in diluted tank. The instrument will aspirate
sample into 5uL sample ring. The flow direction of diluted sample is: diluted tank ->
puncher probe -> six-way valve -> sample ring -> 5mL plunger pump.

6.3. Diluted sample aspiration line


The instrument will aspirate the diluted sample directly into 5uL sample ring. The only
power source for diluted sample is 5mL plunger pump. And the sample flow direction is:
diluted sample -> puncture probe -> six-way valve -> 5uL sample ring -> 5mL plunger
pump.
Chapter 6 Liquid Flowing H100 Service Manual

6.4. High-pressure pump cleaning line

Diluted tank

SV 5

The instrument will cleaning the HP pump after instrument finished. The flow direction
is: L reagent -> 5mL plunger pump -> SV 5 -> High pressure pump ->diluted tank ->
bottom wasted filter -> wasted pump -> wasted tank.

6.5. L reagent dispose


The instrument will aspirate the L reagent from bottle into diluted tank to diluted the
whole blood and anemia sample.

The instrument will aspirate the L reagent from L reagent bottle into diluted tank to
diluted whole blood sample for prepare for testing. The flow direction of L reagent is: L
reagent bottle -> SV9 -> 5mL plunger pump -> SV6 -> diluted tank.
Chapter 6 Liquid Flowing H100 Service Manual

Evacuation valve

High-pressure pump
SV 6
Chapter 7 software H100 Service Manual

Chapter 7 software
7.1. Start up

Picture 7-1 Start up

When the operator starts up the instrument, the instrument will be showing “Start up”
procedure, and get into “Login” interface.

7.2. Login

Picture 7-2 Log in

Operator log in instrument from this interface, we have three account to log in the
system.
Chapter 7 software H100 Service Manual

Account Password Level

1 h100 123 *

2 lifo 661166 **

3 maintain 661166 ***


H100 Account List
We have three level account for H100, h100, lifo, maintain.
1. Account h100: this account is for operator, used for daily used
2. Account lifo: this account is for engineer, under this account, the operator have the
function of below.
1 Create * level account
2 Able to choose skip system cleaning

3. Account maintain: this account is for engineer, under this account, the operator has
the function of below.
1 Create * and ** level account
2 Able to log in service interface
3 Able to delete single test result
4 Able to delete all test result
5 Able to delete single “Log” record
6 Able to delete all “Log” record
7 Direct skip system cleaning

7.3. Test
Sample Warning error Chromatographic Test details
Test mode Sample Type Sample result Time and date

No. of test

ST sample
Start bottom
result
ST sample
type
ST sample Instrument
ID reagent details

Picture 7-3 Test Interface


Chapter 7 software H100 Service Manual

1. Test mode: on H100, we have two test mode, Variant and thalassemia. In here will
show the instrument is test the sample under which test mode.
2. Sample ID: in this line, it will be showing sample’s ID.
3. Sample type: H100 can test two type sample, whole blood and pre-diluted sample. For
whole blood, will showing “W.B.”, for pre-diluted sample, will showing “D.B.”
4. Warning error: in here, the instrument will showing the instrument’s system error.
5. Sample result: after sample test finished, the result will be showing in here.
6. Chromatographic: when instrument doing the sample test, the sample graphic will be
showing the chromatographic in this area.
7. Time and date: in here, the instrument is showing system time and date.
8. No. of test: In this line, it is showing the No. of the sample.
9. ST sample result: in here, it is showing ST’s sample result.
10. ST sample type: in here, it is showing ST’s sample type. For whole blood, will showing
“W.B.”, for pre-diluted sample, will showing “D.B.”
11. ST sample ID: in here, it is showing ST sample’s ID.
12. Start bottom: after operator click this bottom, the instrument will start the sample test.
13. Instrument reagent details: in here, the instrument is showing the instrument’s reagent
details. And operator can reset the reagent in this area.

7.4. Calibration

Two times
calibration
details

Manual
Calibrator adjustment
information

Picture 7-4 Calibration Interface

1. Two times calibration details: in instrument, will be showing two times calibration result
which is done by instrument is recently.

2. Calibrator information: in this area, will showing calibrator information. Include


calibrator lot number, target valve, and test result.

3. Manual adjustment: the valid range of the calibration factor K should be in range:
0.8000~1.2000 and the factor B should be in range: -2.0000~2.0000.
Chapter 7 software H100 Service Manual

7.5. QC

Specific day QC Present Month


information QC

Monthly QC
history

QC
L-J data

Picture 7-5 QC Interface

1. Monthly QC history: the operator can check the specific month and level of QC’s

target valve, SD and CV.

2. L-J graphic: after you choose the level and month of QC in “Monthly QC history”,

the monthly QC result will be showing in this “L-J graphic”.

3. Specific day QC information: after the operator choose the details in “Monthly QC

history” and the point of “L-J graphic”, in this area will be showing the details of QC

point, include QC’s level, target, deviation and result.

4. Present Month QC information: in this area, the instrument will be calculating mean

value, SD and CV result of the monthly which you choose in “Monthly QC history”.

5. QC data: in this area, the operator show enter the lot number of the QC, and the target

valve and deviation of the QC. Also, the QC’s test result will be showing in this area.
Chapter 7 software H100 Service Manual

7.6. Result

Error remark

Picture 7-6 Result Interface

Key Functions

: Return to result interface

: Display the previous page

: Display the next page

: Display the last page

: Delete the selected result

: Delete all results

: Print the selected result

: Display the details of selected sample result

: Export sample results to U-disk

Display content

1.Number Test SN
2.Sample No. Sample ID
3.Type Sample type
4.Date and time Analysis time
Chapter 7 software H100 Service Manual

5.HbF(%) HbF ratio


6.HbA1c(%) HbA1c ratio
7.HbA2 (%) HbA2 ratio (in 380s Result)
8.Remark Remark

The operator can click “Previous” or “Next” button to review analysis results in
the form of list. Data shown in the list includes sample SN, sample ID, sample type,
analysis date, analysis time, HbF ratio, HbA1c ratio, HbA2 ratio, and remark. After
selecting a result entry, click for Details. Also, the system allows query of results by
sample ID and date.
During the testing, only the results of the current page are allowed to be viewed,
and no other actions are allowed.

About the explanation of abnormal results

If the test results are abnormal, the “Remark “column will display the corresponding
code (e1 ~ e10).

The meaning of the codes are as follows:


e1:Total area less than 50,000;
e2:Total area more than 270,000;
e3:Result more than 15%;
e4:Result less than 4%;
e5:Variants detected;
e6:ADC415 value reach max value during testing;
e7:A0 Total area less than 80%;
e8:Target peak is out of range;
e9:Pressure is abnormal;
e10:TP is too low
Chapter 7 software H100 Service Manual

7.7. Log

Picture 7-7 Log Interface

Key Functions

: Return to result interface

: Display the previous page

: Display the next page

: Display the last page

: Delete the selected result

: Delete all results

Instrument error code:

Error code Details


0x1001 Eluent A limit
0x1002 Eluent B limit
0x1003 Eluent C limit
0x1004 Hemolytic L limit
0x1005 In-line filter limit
0x1006 Column limit
0x1007 Wasted full
Chapter 7 software H100 Service Manual

0x1008 Pressure low


0x1009 Pressure high
0x100A Fan blocking
0x100B Eluent D limit
0x100C Front cover open

Hardware error code:

Error
Failure module Details
code
1 / Unknown command
2 / Instruction parameter error
3 / The instruction stream is executing
5 / Memory insufficient
6 / Z axis movement affected by X axis movement

7 / The instruction queue was cleared


Z-axis motor interferes when
8 /
returning the sample rack
When returning the sample rack,
9 /
the door interferes
0XC8 / parameter error
0XC9 / Default parameter
0xFF / Will stop over 255
0XFE / Operation failed
0xFD / Open ST position failed
0x0102 High-pressure pump motor Try to operate the motor which is moving
0x0103 High-pressure pump motor The disk lost its step
0x0104 High-pressure pump motor Target location is out of the maximum limit
0x0105 High-pressure pump motor Sensor reset error
0x0106 High-pressure pump motor Wait for movement to end timeout
0x0107 High-pressure pump motor The controller is not initialized
0x0202 5mL plunger pump motor Try to operate a running motor
0x0203 5mL plunger pump motor The disk lost its step
0x0204 5mL plunger pump motor Target location is out of the maximum limit
0x0205 5mL plunger pump motor Sensor reset error
0x0206 5mL plunger pump motor Wait for movement to end timeout
Chapter 7 software H100 Service Manual

0x0207 5mL plunger pump motor The controller is not initialized


0x0302 100mL plunger pump motor Try to operate a running motor
0x0303 100mL plunger pump motor The disk lost its step
0x0304 100mL plunger pump motor Target location is out of the maximum limit
0x0305 100mL plunger pump motor Sensor reset error
0x0306 100mL plunger pump motor Wait for movement to end timeout
0x0307 100mL plunger pump motor The controller is not initialized
0x0402 X axis motor Try to operate a running motor
0x0403 X axis motor The disk lost its step
0x0404 X axis motor Target location is out of the maximum limit
0x0405 X axis motor Sensor reset error
0x0406 X axis motor Wait for movement to end timeout
0x0407 X axis motor The controller is not initialized
0x0502 Z axis motor Try to operate a running motor
0x0503 Z axis motor The disk lost its step
0x0504 Z axis motor Target location is out of the maximum limit
0x0505 Z axis motor Sensor reset error
0x0506 Z axis motor Wait for movement to end timeout
0x0507 Z axis motor The controller is not initialized
0x0602 loading motor Try to operate a running motor
0x0603 loading motor The disk lost its step
0x0604 loading motor Target location is out of the maximum limit
0x0605 loading motor Sensor reset error
0x0606 loading motor Wait for movement to end timeout
0x0607 loading motor The controller is not initialized
The motor is running.
0X0701 Transfer motor
Try to start the running motor
0X0702 Transfer motor parameter error
0X0703 Transfer motor The target position is set
0X0704 Transfer motor Target location exceeds maximum travel
0X0705 Transfer motor Lost step
Example Reset an optical
0X0706 Transfer motor
coupler exception
0X0707 Transfer motor Communication anomaly
0X0708 Transfer motor Wait timeout
Chapter 7 software H100 Service Manual

Over number sample rack


0X0710 Transfer motor
on sampler unloading side
The motor is running.
0X0901 Scanning rotary machine
Try to start the running motor
0X0902 Scanning rotary machine parameter error
0X0903 Scanning rotary machine The target position is set
0X0904 Scanning rotary machine Target location exceeds maximum travel
0X0905 Scanning rotary machine Lost step
Example Reset an
0X0906 Scanning rotary machine
optical coupler exception
0X0907 Scanning rotary machine Communication error
0X0908 Scanning rotary machine Overtime waiting
The motor is running.
0X0A01 Scanning and clamping motor
Try to start the running motor
0X0A02 Scanning and clamping motor parameter error
0X0A03 Scanning and clamping motor The target position is set
0X0A04 Scanning and clamping motor Target location exceeds maximum travel
0X0A05 Scanning and clamping motor Lost step
Example Reset an
0X0A06 Scanning and clamping motor
optical coupler exception
0X0A07 Scanning and clamping motor Communication error
0X0A08 Scanning and clamping motor Overtime waiting
The motor is running.
0X0D01 Shake left right motor
Try to start the running motor
0X0D02 Shake left right motor parameter error
0X0D03 Shake left right motor The target position is set
0X0D04 Shake left right motor Target location exceeds maximum travel
0X0D05 Shake left right motor Lost step
Example Reset an
0X0D06 Shake left right motor
optical coupler exception
0X0D07 Shake left right motor Communication error
0X0D08 Shake left right motor Overtime waiting
0x0D09 Shake left right motor Crushing before moving
0x0D0A Shake left right motor Lost step when moving into reset position
The motor is running.
0X0E01 Shake up down motor
Try to start the running motor
0X0E02 Shake up down motor parameter error
Chapter 7 software H100 Service Manual

0X0E03 Shake up down motor The target position is set


0X0E04 Shake up down motor Target location exceeds maximum travel
0X0E05 Shake up down motor Lost step
Example Reset an
0X0E06 Shake up down motor
optical coupler exception
0X0E07 Shake up down motor Communication error
0X0E08 Shake up down motor Overtime waiting
Motor is lost step or stuck
0X0E0A Shake up down motor
when it is moving up
Motor is lost step or stuck
0x0E09 Shake up down motor
when it is moving down
The motor is running.
0X0F01 Sample bit clamp motor
Try to start the running motor
0X0F02 Sample bit clamp motor parameter error
0X0F03 Sample bit clamp motor The target position is set
0X0F04 Sample bit clamp motor Target location exceeds maximum travel
0X0F05 Sample bit clamp motor Lost step
Example Reset an
0X0F06 Sample bit clamp motor
optical coupler exception
0X0F07 Sample bit clamp motor Communication error
0X0F08 Sample bit clamp motor Overtime waiting
The motor is running.
0X1F01 Unloading motor
Try to start the running motor
0X1F02 Unloading motor parameter error
0X1F03 Unloading motor The target position is set
0X1F04 Unloading motor Target location exceeds maximum travel
0X1F05 Unloading motor Lost step
Example Reset an
0X1F06 Unloading motor
optical coupler exception
0X1F07 Unloading motor Communication error
0X1F08 Unloading motor Overtime waiting
0X1F09 Unloading motor The offloading platform is full
The unloading motor is stuck
0X1F0A Unloading motor
when pushing out
0X1F0B Unloading motor Data errors
0X1F0C Unloading motor The sample rack is busy
0X2000 Driver board Acquisition of the actuated
Chapter 7 software H100 Service Manual

analog optocoupler ADC1 failed


Driver board Acquisition of the actuated
0X2001
analog optocoupler ADC2 failed
Driver board Acquisition of the actuated
0X2002
analog optocoupler ADC3 failed
Driver board Acquisition of the actuated
0X2003
analog optocoupler ADC4 failed
0X2004 Driver board Failed to get driver board version status
Failed to get SVN version
0X2005 Driver board
status of driver board
Failed to get the hardware version
0X2006 Driver board
status of the driver board
Failed to get loading side
0X2020 Driver board
board version status
Failed to get SVN version
0X2021 Driver board
status of loading side board
Failed to get the hardware version
0X2022 Driver board
status of the loading side board
Failure to acquire the injector to
0X2023 Driver board
simulate the optocoupler ADC1
Failure to acquire the injector to
0X2024 Driver board
simulate the optocoupler ADC2
Failure to acquire the injector to
0X2025 Driver board
simulate the optocoupler ADC3
Failure to acquire the injector to
0X2026 Driver board
simulate the optocoupler ADC4

Error board image

High-pressure pump
Chapter 7 software H100 Service Manual

5mL plunger pump

100uL plunger pump


Chapter 7 software H100 Service Manual

2D arm assembly X axis motor


Chapter 7 software H100 Service Manual

2D arm assembly Z axis motor

loading motor
Chapter 7 software H100 Service Manual

Transfer motor

Scanning rotary machine


Chapter 7 software H100 Service Manual

Scanning and clamping motor

Shake left right motor


Chapter 7 software H100 Service Manual

Shake up down motor

Sample bit clamp motor


Chapter 7 software H100 Service Manual

Unloading motor

7.8. System -> Maintenance

Picture 7-8 System Interface

Bubble Elimination
When air bubbles appear in high pressure pump, system pressure cannot
increase to the normal range of 5-8MPa and meanwhile eluents cannot flow. The
analyzer will activate an error alarm indicating low pressure of the high pressure pump.
At this moment, bubble elimination should be performed. Please click “Bubble
Chapter 7 software H100 Service Manual

Elimination”, and turn on the evacuation valve as prompted on the interface. The
analyzer will execute bubble elimination then. After air bubbles are eliminated, please
re-tighten the evacuation valve.

Empty Test
Empty Test is used to test whether the elution process of the analyzer is correct.
Meanwhile, empty test can also eliminate reagent peaks. Please click “Empty Test” to
perform the procedure after removing the sample from the sample loader. The
acceptance criterion for empty test is that the red and blue lines are smooth and
highly coincide with each other.
When the pump speed of the analyzer, reagent and column change, empty test
should be executed again.

Dispose Reagent L
Reagent L is Hemolytic Agent L. Before disposing Hemolytic Agent L, please
place an EP tube with holder at STAT. position. After that, please click “Dispose
Reagent L” to perform the procedure. The analyzer will automatically aspirate 1500μL
from the Hemolytic Agent L bucket, and inject the Hemolytic Agent L into the EP tube
via the sampling needle for future use during calibration or QC operation or to pre-dilte
samples.
Reset Loader
Please click “Reset Loader” to reset the sample loader to original situation after
removing the sample rack from the sample loader.

Maintain Probe
If the probe need to be maintained, please click “Maintain Probe ” button and a
prompt will show “Confirm to maintain probe?”. Click “Yes”, and a prompt will show
“please place a W.B. tube with 5 ml cleaning solution in STAT Port”. Place 5mL
Cleaning Solution (HPLC) specified by manufacturer and designated agent as
required and start the probe maintenance procedure. The instrument automatically
absorbs the cleaning fluid and carry out the probe maintenance operation. The
sampling probe automatically resets after the completion of the maintenance. Finally,
dispose of used cleaning solution complying with local laws and regulations.
 The Cleaning Solution (HPLC) can not be reused.

Cleaning
Cleaning function helps to the cleaning of H.P. pump, diluted tank, probe inner
Chapter 7 software H100 Service Manual

wall, probe outer wall and (liquid line) system. This section takes “Diluted Tank”
cleaning as an example to introduce this function. The operation steps are as follows:

1) Click “Diluted Tank” on the System interface.


2) Click “Yes” button and it will enter the cleaning procedure.
3) After cleaning, it will automatically return to the system interface.
4) The same goes for the cleaning of H.P. pump, probe inner wall, probe outer wall
and (liquid line) system cleaning function.

Replacement
 Replacement function helps to replace eluent A/B/C/D and Hemolytic Agent L.
 This section takes the replacement of eluent A as an example to illustrate this
function. The operation steps are as following:

1) Prepare aluminum foil bag with eluent A, connect the liquid line and screw up the
lid of the bag.
2) Click ”A” button, it will display eluent A replacement interface.
3) Click “Replace” button.
4) Input correct eluent A Lot.
5) Click “Yes”.
6) If not, click “Cancel” to quit the procedure.

Prime Liquid Line


When installing the analyzer, please prime the liquid line to ensure proper sample
sucking during sample analysis. Please click “Prime Liquid Line” and open the
evacuation valve as prompted on the interface.
Please execute this step with caution as it consumes much hemolysis reagent
and may lead to a lack of hemolysis reagent in the following operation.

Empty The Liquid Line


Before emptying the liquid line, please disconnect Hemolytic Agent L and eluents
A、B、C and D. After emptying the liquid line, the liquid path of the entire analyzer is
empty.
Chapter 7 software H100 Service Manual

Pack
1) Empty the liquid path;
2) Perfuse the liquid path with deionized water;
3) Empty the liquid path again.
This operation applies when the analyzer is to be left unused for a long period or
be transported for a long distance.

(Col.Temp)Temperature of Chromatographic Column


It is suggested that the column temperature should be set 30~40 ℃ . If the
analyzer is at an abnormal operating temperature, it may affect the column
temperature and further the peak appearance time of HbA1c. The higher the
temperature is, the sooner the peak appearance will be, vice versa. The column
temperature is suggested to be adjusted to make the peak appearance time fall within
the specified range to ensure accurate test results.

(Amb.Temp) Ambient Temperature


The ambient temperature for normal operation of the analyzer is between
10~30℃, and 25℃ is recommended. Beyond this range, the analysis results may be
affected.

ADC415
The analyzer uses a high-precision photoelectric sampling system, and also
employs the dual-wavelength detection technique to eliminate system interference
and non-specific absorption of hemoglobin. In normal status, the ADC415 value is
within the range of 24000~28000; the ADC value is determined by the LED value and
the gain. The ADC value is in direct proportion to the LED value — the higher the LED
value is, the higher the ADC value will be. The ADC value is inversely proportional to
the gain — the higher the gain is, the smaller the ADC value will be.
If the ADC value cannot fall within the normal range after adjusting the LED value
and the gain, please confirm whether there are air bubbles in the cell and whether the
illuminating surface of the cell is dirty under the precondition that the system pressure
is normal.

ADC500
Similar to ADC415, the ADC500 value in normal status is within the range of
16000~20000. It is also affected by the LED value and the gain; the ADC value
debugging method is identical to that for ADC415.
Chapter 7 software H100 Service Manual

Pressure
The system pressure can reach above 5-8MPa, which increases as the number
of test increases. If the pressure is 4MPa above the pressure indicated on the product
delivery identification of the chromatographic Column, please first replace the filter. If
the pressure does not drop, please replace the chromatographic Column. The
analyzer will activate an alarm and the test will be interrupted if the system pressure is
beyond the set range.

7.9. System -> Settings

Screen Brightness/Target Temperature


The range of screen brightness is 0~100%. Users can adjust it as needed.
Temperature setting is used to set the temperature in the column oven. Peak
appearance time of target proteins relates to the temperature. It is suggested that
target temperature should be set in the range of 25~40℃.

Print Mode
Before printing test results, please prepare a printer. Two print modes are
available: Auto Print and Manual Print. If you click “Auto”, test results selected will be
printed automatically after each sample test. If you click “Manual”, test results
selected can be printed only in the result interface.

Print Items
To save printing paper, users can selectively print the following three items:

 Test Items: print the peak appearance time, absorbance, total area and
Chapter 7 software H100 Service Manual

results in percentage of each hemoglobin component.

 Graph: print the chromatogram of the current sample.

 Result: print the IFCC concentration in the analysis result of the current

sample and the estimated blood glucose level expressed in two units.

Waste Discharge
 Barreled: please ensure that a waste barrel is connected before clicking

“Barreled”. Please dispose of the waste in the waste liquid barrel when

the analyzer activates the alarm that the barrel is full.

 Direct Discharge: please obey the laws and regulations about direct

discharge to implement this procedure.

Eluent
 Double: you can activate the eluents on the left or right side as needed.

 1st channel: you can only activate the eluents on the left side.

 2st channel: you can only activate the eluents on the right side.

Network
This function is used to set the IP address and network port of the analyzer and
realize LIS/HIS transmission. Please refer to Annex B.
Chapter 7 software H100 Service Manual

DateTime
This operation is used to set system time. After resetting, the system time will be
updated at the upper right of the screen. Because QC data are stored according to the
current system time and the analyzer only records one-year QC data, if system time is
set wrong and the QC operation is executed, the correct QC data will be deleted.
Please operate with caution.

7.10.System -> Statistics

Total test
The operator can calculate the total test in this interface. The operator can
calculate the sample test numbers about all the test result, sample result, calibration
result and QC result. the operator can also calculate the number by choose specific
Chapter 7 software H100 Service Manual

time, and the total test number will be showing in “Sum”. Average number will be
calculated automatically in “Averange”.

Reagent status
In this interface, the instrument will calculate the reagent remaining, and showing
in “Statistics” interface.

7.11.System -> About

In this interface, the instrument will be showing the instrument’s software version
details.

7.12.System -> Help

In this interface, the instrument is showing user manual.

7.13.System -> Service

In this interface, the operator can get into service interface, the account and
password, please find Lifotronic service team or agent.

7.14.System -> Service-> Pump and valve test

In this interface, the operator can control the instrument all the valve and pump’s
open and close to check these spare part’s working status.

7.15.System -> Service-> Motor test


Chapter 7 software H100 Service Manual

In this interface, the operator can control the movement of 2D arm assembly, 5mL
plunger pump and 100uL plunger pump. To check the status of these spare part.

7.16.System -> Service-> Optical sensor test

In this interface, the operator can control and monitor the status of some spare
part.
X Motor Reset: reset the X motor into original place.
Z Motor Reset: reset the X motor into original place
5mL Top: when 5mL plunger pump is on the top, this choice will be chosen.
100uL Top: when 100uL plunger pump is on the top, this choice will be chosen.
H.P.: High-pressure pump is using coded disk to check the status of the status.
When the sensor detect coded disk is not reflash the sensor, Block will be chosen,
otherwise Unblock will be chosen.
Waste Liquid: the instrument will use backside waste sensor to check the waste
reagent. When it is full, full will be chosen. Otherwise, not full will be chosen.
Chapter 7 software H100 Service Manual

Fan: the instrument using fan to cooling the inside of the instrument, when the fan
is working, on will be chosen. Otherwise, off will be chosen.
Normal position W.B. and D.B.: it is used to check the 2D arm’s depth. When
operator choose W.B., the aspiration probe will go to the bottom of Auto sampler
side’s whole blood tube. When operator choose D.B., the aspiration probe will go to
the bottom of Auto sampler side’s EP tube.
STAT position W.B. and D.B.: it is used to check the 2D arm’s depth. When
operator choose W.B., the aspiration probe will go to the bottom of STAT position’s
whole blood tube. When operator choose D.B., the aspiration probe will go to the
bottom of STAT position’s EP tube.
STAT position Exit and Empty:
Load position: when auto sampler loading position has sample rack, then exist
will be chosen. Otherwise, Empty will be chosen.
Unload position: when auto sampler unloading position is full with sample rack,
then

7.17.System -> Service-> 2D arm setting

1. Dilution tank

Click ,the 2D arm will move to the dilution tank position as below.

Pr obe wipe r is
in the ce nte r
of dil utio n
Chapter 7 software H100 Service Manual

Click <++,+,-,--> to make the probe wiper more centered, then click <Save>.

2. Top of dilution tank

Click <Next>, the probe will move to the top of dilution tank position as below.

Pr obe and
Pr obe is in dilutio n tan k
th e ce nte r of are at th e
dilutio n hol e same he ight
Chapter 7 software H100 Service Manual

Click <++,+,-,--> to make the probe and dilution tank ar e at the sam e

height , then click <Save>.

3. Probe Wiper

Click <Next>, the probe will move upward to the wiper position.
Click <++,+,-,--> to set Probe Wiper value to 100 as default, then click <Save>.

4. Normal port

Click <Next>, the probe will move to the normal rack position. Put a rack with an

empty tube to normal position:

Center

Click <++,+,-,--> to set probe X axis in the center of tube, then click <Save>.

5. Diluted blood sample

Put a mic ro- EP tube and dilution sample holder int o #10 of rack, move

the EP tube to aspir ation pos it ion.

Click <Next>, the probe will move downward:

2m m fr om th e
Mov e th e mi cr o-E P pr o be and
tu be up and do wn mic r o-E P tube
by man ual to che c k. bo tto m

Click <++,+,-,--> to set probe Z axis to make sure there is 2m m from the pr obe
Chapter 7 software H100 Service Manual

and mic ro EP

tub e bo ttom . Move the micro -EP tu be up and do wn by ma nu al to ch eck ,

then click <Save>. Take out the rack.

6. Whole blood sample

Put an empt y whole blood tube without cap int o #10 of rack, move the

rack to as pir ation posit ion.

Click <Next>, the probe will move downward:

2m m fr om th e
Mov e the who le
pr o be and who le
bl oo d tu be up and
bl oo d tu be
do wn by man ual to
bo tto m
che ck .

Click <++,+,-,--> to set probe Z axis to make sure there is 2m m from the pr obe

and whole blood tube bot t om. Mov e the whole blood tube up and dow n by

manual to check,

then click <Save>.Take out the rack.

7. STAT Position

Put an empt y whole blood tube without cap int o ST A T pos it ion.

Click <Next>, the probe will move outward:

Cen ter
Chapter 7 software H100 Service Manual

Click <++,+,-,--> to set probe X axis o make sure it is center of tube.

then click <Save>.Take out the tube.

8. STAT Diluted blood sample

Put a mic ro- EP tube and holder int o ST AT pos it ion.

Click <Next>, the probe will move downward:

Mo v e th e mi cr o-E P 2m m fr om th e
tube up and do wn pro be and
by man ual to che c k . mi cr o-E P tu be
botto m

Click <++,+,-,--> to set probe Z axis to make sure there is 2mm from the probe

and micro EP

tube bottom. Move the micro-EP tube up and down by manual to check, then

click <Save>.

Take out the holder.

9. STAT Whole blood sample

Put an empt y whole blood tube without cap int o ST A T pos it ion.

Click <Next>, the probe will move downward:

Mov e th e who le 2m m fr om th e
bloo d tu be up an d pr obe and who le
dow n by man ual to blo o d tu be bo tto m
che c k.
Chapter 7 software H100 Service Manual

Click <++,+,-,--> to set probe Z axis to make sure there is 2mm from the probe

and whole blood tube bottom. Move the whole blood tube up and down by manual to

check, then click <Save>.Take out the tube

7.18.System -> Service-> Loader->Parameter

1. Before testing, prepare a normal sample rack, place 2 empty

whole blood tubes on positions 1 # and 5 #, and the sample rack and tubes shall be

affixed with normal bar code.

2. Place the sample rack in the inlet of auto sampler and place an empty

whole blood tube in STAT position.

3. Click <Start> to enter auto sampler adjustment mode, and

will highlight.

4. adjustment

click to adjust 2 protruding parts on the belt,

Make it align with the inlet of auto sampler, center in the left and right, and click

<Save> to save the parameters. As shown below:


Chapter 7 software H100 Service Manual

5. adjustment:

Select ,rack shift in device will move the rack to the belt position,

click to adjust the space between rack and micro switch:

Micro switch should be


pressed just to the bottom

Micro switch should be pressed just to the bottom by the rack.

Click <Save> to save the parameters.

6. adjustment:

Select ,rack will move to the scanning position,

Click ,belt will drive the sample rack to the central scanning
Chapter 7 software H100 Service Manual

position.

1 # tube
occupies Loosen these two screws
highest to adjust position of
point of scanner
middle
roller

Click <Save> to save the parameters.

Select<Test>, Scanner starts working and emits a white light as indicator.

Loosen these two screws to adjust position of scanner, make it in the middle of

tube.

Tighten it finally.

7. adjustment:

Select ,rotator will start getting close the tube,

Click ,make rotator right next to the tube, click <+> for 5 times,

Then click <Test> for 10 times, tube can be rotated smoothly, then Click <Save> to

Rotator

save the parameters.


Chapter 7 software H100 Service Manual

8. adjustment:

Select ,belt will push the rack to the aspiration position.

Click to adjust the belt position, make tube is in the

middle of clamping jaw and baffle.

Then click <Save> to save the parameters.

Clamping jaw

Middle position
Baffle

9. adjustment:

Select ,the clamping block will press the tube.

Click to adjust the clamping position, make sure tube will not

fall down after raising it by hand.

Then click <Save> to save the parameter.

Clamping block
pressing the tube
Chapter 7 software H100 Service Manual

10. adjustment:

Select ,2-D arm will move the probe to the aspiration position.

Click to adjust the aspiration position, make sure probe is

placed in the middle.

Then click <Save> to save the parameter.

Center

11. adjustment:

Select ,the belt will move the rack to the left clamping position.

Click to adjust the rack position, make sure tube is placed in

the middle.

Then click <Save> to save the parameter.

Left clamping block

Center
Chapter 7 software H100 Service Manual

12. adjustment:

Select ,the mixing unit will go up.

Click to adjust the height of mixing unit, make sure it is 3mm

higher than the rack.

Then click <Save> to save the parameter.

Tube is
clamped in the 3mm between
rack and mixing
unit

13. adjustment:

Select ,the mixing unit will go back to original position.

Click to adjust the angle of mixing unit, make sure it is

horizontal with rack.

Then click <Save> to save the parameter.

Mixing unit horizontal with


rack
Chapter 7 software H100 Service Manual

14. adjustment:

Select ,the mixing unit will go forward to clamp the tube.

Click to adjust the angle of mixing unit, make sure the tube is

clamped in the center.

Then click <Save> to save the parameter.

Tube is
clamped in the

15. adjustment:

Select ,the mixing unit will go up with the tube.

Click to adjust the height of mixing unit, make sure there is 3mm

between tube and rack.

Then click <Save> to save the parameter.

3mm between
rack and tube
Chapter 7 software H100 Service Manual

16. adjustment:

Select ,the belt will push the rack to the outlet of auto sampler.

Click to adjust the position of rack, make sure the rack is in the

center of outlet.

Then click <Save> to save the parameter.

17. adjustment:

Select ,the load off unit will push the rack to the outlet of auto sampler.

Click to adjust the position of rack, make sure the rack is on the

metal floor.

Then click <Save> to save the parameter.

Load-off unit
Chapter 7 software H100 Service Manual

7.19.System -> Service-> Loader->Threshold

Set this AD 1000


as default

Remove all the rack and whole blood tubes from the auto sampler before setting.

Set Barcode scanning position Benchmark AD to 1000 as default. Click <Save>. All the

Current AD should be between 3400 - 3500.

If out of range, need to adjust the adjustable resistance in driver board of auto sampler

as below (Increase clockwise and decrease counterclockwise):


Adjustable resistance position Optocoupler
VR4 STAT sample position
VR1 Barcode scanning position
VR2 Mixing unit position

VR4

VR2 VR1
Chapter 7 software H100 Service Manual

7.20.System -> Service-> General Setting-> Parameter

1. W.B. Var (uL): this is the place set the whole blood aspiration for Variant test

mode.

2. W.B. Tha (uL): this is the place set the whole blood aspiration for thalassemia

test mode.

3. Anemic (uL): this is the place set the whole blood anemic sample rack’s

sample.

4. HbA1c> : the reference range low valve setting place.

5. HbA1c< : the reference range high valve setting place.

6. DAC_LED: this is the place where adjust 415nm and 500 nm wavelength’s

strength.

7. Gain415: this is the place where adjust 415nm ADC valve.

8. Gain500: this is the place where adjust 500nm ADC valve.

9. HP_Var: this is the place where adjust the high pressure pump speed for

variant test mode.

10. HP_Tha: this is the place where adjust the high pressure pump speed for

thalassemia test mode.

11. Pressure Cal: this is the place where adjust pressure sensor’s detected
Chapter 7 software H100 Service Manual

pressure at that moment into 0 valve.

12. Last time: Pressure Cal’s last time pressure sensor adjustment result.

13. This time: Pressure Cal’s this time pressure sensor adjustment result.

14. Pressure (Mpa)> : Pressure waring range’s low limit valve.

15. Pressure (Mpa)< : Pressure waring range’s high limit valve.

16. Primer count: Primer count number setting place.

17. Sleep (min): Instrument get into sleeping time.

18. Reference line: turn on and off graphic reference line.

19. Printer: using internal printer or external printer.

20. Language: choosing Chinese or English version of software.

21. Precision: choose HbA1c result is in 1 decimal or 2 decimals.

22. Stop when cover open: choose “on” the instrument will stop when operator

open the front cover. Choose “off” the instrument will continue working when

operator open the front cover.

7.21.System -> Service-> General Setting-> Function

1. Cal. Format:

2. QC Format:

3. Consume Format:

4. Update MCU: press this bottom then will upgrade the MCU.

5. Export Log: press this bottom then will export the instrument all log
Chapter 7 software H100 Service Manual

information.

6. Backup Data: press this bottom will backup the instrument’s all the data in to

flash disk.

7. Import Data: press this bottom will import all the backup data which you

backup previously from flash disk into instrument.

8. Screen Cal: calibrate the screen.

9. Auto E.T.: when operator turn on this function, then the instrument will doing a

empty test before sample test.

10. HbJ: open the HbJ detection window.

11. HbS: open the HbS detection window.

12. 3-Zero Stop: the instrument will stop test the sample when detect continue 3

sample result are all 0.

7.22.System -> Service-> Performance Testing

W.B.: the operator can choose to do repeatability test in this interface, the

number behind the repeatability is repeat sample time. Before you start the

sample test, please place a whole blood sample which operator ready to test in

sample rack 1st place. Then press the start bottom can start the repeatability test.

7.23.System -> Service-> User management


Chapter 7 software H100 Service Manual

1. Account Info: The operator can check log in account in this interface.

2. Register Account: the operator can create account in this interface.

3. Change Password: the operator can change the password of created

account.

4. Account List: the operator can check the account which is lower than the

account which operator log in.

7.24.Software upgradation

1. Upgrade SYS system software

Upgrade SYS software will be cleaning all the instrument test data,

before the operator upgrade SYS, please follow 7.25 backup data,

backup all the instrument data. After finished upgradation, please follow

7.26 reloading data.

Tool list of upgradation:

Tool name Number

Laptop/Computer 1

TF card (please find Lifotronic’s partner to purchase) 1

Card reader (For loading software in TF card) 1

Operation:

a) Copy the SYS system software in TF card’s root directory, and check did

operator copy correct software file into TF card (show as picture below).
Chapter 7 software H100 Service Manual

b) Plug in the TF card into instrument main control board (check the picture

where the TF card should plug in)

c) Turn on the instrument, and wait for about 120S, and wait for yellow light

signing, that means the instrument upgrade successfully.


Chapter 7 software H100 Service Manual

d) Turn off the instrument, and remove the TF card. Upgrade SYS system

is finished.

Attention: after the operator upgrade the SYS system, the instrument is

working under without analyze software (APP and MCU), the operator

need to follow the software upgradation step to upgrade APP and MCU

to start the instrument’s sample analyze.

2. Upgrade APP and MCU

Tool list of upgradation:

Tool name Number

Laptop / PC 1

Flash disk 1

Operation:

a) Copy the APP and MCU software in flash disk’s root directory (update),

and check did operator copy correct software file into update root

directory (show as picture below).

b) Plug in the flash disk in back side instrument’s USB port, and turn on the

instrument

c) After turn on the instrument, the system will showing the interface let you
Chapter 7 software H100 Service Manual

choose whether upgrade the software, please click the screen and

proceed. If you don’t want to upgrade the software, please turn off the

instrument.

d) After the operator click the screen, wait for about 10-20S, and the screen

will turn into this picture show as below. Which means the APP software

upgrade successfully.

e) Turn off the instrument and remove the flash disk, upgrade APP

software is done.

f) Turn on the instrument, after the instrument get into software (show as

picture below), continue plug in the same flash disk as Step b.


Chapter 7 software H100 Service Manual

g) Go to service interface -> General Setting, press update MCU. And wait

for about 1 min, and wait for main control board’s yellow light sighting.

Which means MCU software upgrade finished.


Chapter 7 software H100 Service Manual

h) Turn off the instrument, remove the flash disk, and turn on the instrument

again, in About interface, check the software version.

3. Upgrade auto sampler

Tool list of upgradation:

Tool name Number

Laptop / PC 1

Auto sampler upgradation wire (please find 1

Lifotronic or Lifotronic’s partner for this tools)

RS-232 to USB wire 1

Operation:

a) Connect RS-232 to USB wire and Auto sampler upgradation wire

together, and connect Auto sampler upgradation wire

S1 and S2

Upgrade

b) Open the flyMCU upgrade software, and check the port is same as

RS-232 to USB wire’s port.


Chapter 7 software H100 Service Manual

c) Press the Start ISP bottom

d) After the operator press the Start ISP, press and hold S1 bottom on the

board, then press S2 bottom on the board for 5S and release S2 bottom.

Finally release S1 bottom. Then the software upgradation procedure will

start. If not proceed, continue this step again.

e) Wait for software upgradation finished, then close the flyMCU software.

Turn on the instrument and check the Auto sampler’s software version.

7.25.Backup instrument data

Please backup date before you upgrade the instrument software.

Tool list of backup data:

Tool name Number

Laptop / PC 1

Flash disk 1

Operation:

a) Plug in a empty flash disk on back side USB, and press Backup data of

General setting interface.


Chapter 7 software H100 Service Manual

b) The system will let the operator confirm whether backup data, press Yes

and continue.

c) After successful message appear, means instrument backup date is

done successfully.

d) Remove the flash disk, and plug in the flash disk in laptop / PC, check

the backup data show as picture below.


Chapter 7 software H100 Service Manual

7.26.Import instrument data

Please import the data after you upgrade the instrument software.

Tool list of backup data:

Tool list of backup data:

Tool name Number

Laptop / PC 1

Flash disk 1

Operation:

a) Plug in the flash disk with backup data on back side USB, and press

Import data of General setting interface.

b) The system will let the operator confirm whether Import data, press Yes

and continue.
Chapter 7 software H100 Service Manual

c) After successful message appear, means instrument import data is done

successfully.

d) Go to result interface, check the data.


Chapter 8 Assembly H100 Service Manual

Chapter 8 Assembly

8.1. Constant column heating module

8.1.1. Installing LED PCBA and convex lens

LED PCBA Convex lens Convex lens holder

Convex lens Complex

Install the convex lens complex in constant column heating module, like this picture
show, install the convex lens complex lens side inside of the module inside.

Convex lens Complex

After install the convex lens complex, install the LED board on the constant column
heating module.
Chapter 8 Assembly H100 Service Manual

LED board

8.1.2. Installing 415 nm optical filter and 415 nm acceptor

415 nm
Optical
filter
415 nm
Filter
holder

415 nm optical filter assembly 415 nm acceptor

415 nm filter holder 415 nm optical filter

The engineer should install the 415 nm filter holder on constant column

heating module first, then install the 415 nm filter holder on column heating

module. Before you install the 415 nm optical filter, please use glass special
Chapter 8 Assembly H100 Service Manual

cleaning paper clean the optical filter clean, and not finger print on the surface of

the filter.

415 nm accepter

Install the 415 nm accepter on the constant column heating module.

415 nm
Optical
415 nm
filter
Filter
holder

500 nm optical filter assembly 500 nm acceptor

500 nm filter holder 500 nm optical filter

8.1.3. Installing 415 nm optical filter and 415 nm acceptor

The engineer should install the 500 nm filter holder on constant column

heating module first, then install the 500 nm filter holder on column heating
Chapter 8 Assembly H100 Service Manual

module. Before you install the 500 nm optical filter, please use glass special

cleaning paper clean the optical filter clean, and not finger print on the surface of

the filter.

500 nm accepter

Install the 500 nm accepter on the constant column heating module.

8.1.4. Install two direction mirror

Two direction mirrorr

Install the two direction mirror in constant column heating module, and

make sure before the engineer install this spare part, make sure this spare part is

clean and without any dust

8.1.5. Install the flow cell


Chapter 8 Assembly H100 Service Manual

Install the flow cell and screw it’s fix screws. The flow cell’s in side connector

connect with column, and out side connect with waste filter.

8.2. High-pressure pump assembly

8.2.1. Install the plunger robe connector assembly

Spring Plunger rob assembly

Shaft ring Plunger rob connector assembly

The engineer should install the spring, plunger rob assembly and shaft

ring into plunger rob connector assembly.


Chapter 8 Assembly H100 Service Manual

Diagram Diagram plunger rob assembly

The engineer should install the plunger rob connector assembly on

diagram

8.2.2. Install the diagram connection assembly

Diagram connection assembly Diagram connection assembly on high pressure pump

The engineer should install the four screws to fix the diagram connection

assembly

8.2.3. Install the spring seal


Chapter 8 Assembly H100 Service Manual

Spring seal High pressure pump head

The engineer should install the spring seal on the high pressure pump

head.

8.2.4. Install the high-pressure pump head

The engineer should install the four screws to fix the high-pressure pump

head

8.2.5. Install the one-way assembly

Reagent in Reagent out


(big head) (small head)

One way
assembly
Chapter 8 Assembly H100 Service Manual

Upper one-way assembly lower one-way assembly


(big head) (small head)

The engineer should install the two one-way assembly on the high-pressure

pump head. because of the one-way assembly have the liquid direction requirement,

so when the engineer install the one-way assembly should attention of the direction

of one-way assembly.

For one-way assembly, the small head is reagent get-out side, the big head is

reagent get-in side. for this requirement, the lower side of high-pressure pump

head’s one-way assembly, should install it’s small head to upper direction. the

higher side of high-pressure pump head’s one-way assembly, should install it’s big

head to upper direction.


Chapter 9 Maintenance H100 Service Manual

Chapter 9 Maintenance

Overview
The content of this section involves the maintenance of the device. In order to
keep a stable and good operating state of the device, please maintain the device
as scheduled or on demand according to requirements specified in this chapter.

The spare part which needs to be maintained is listed in the software. Here is the
information below. These spare parts need to be maintained or replaced after
certain amount of testing.

Spare Part Maintenance (Tests) Replacement (Tests)


Probe 1500 30000
Six-way Valve rotor 6000 18000
Sample Loop / 7000
Diluted Tank 1600 /
Pre-Filter 15000 /
Waste Filter 20000 30000
Wiper Filter 10000 10000

9.1. Daily maintenance

1) Check A, B, C, D eluent, column and filter remain, make sure the

instrument have enough reagent remain to do the sample test.

9.2. Weekly maintenance

1) Clean the probe


Dirt in the probe will affect aspiration which may result in incorrect total area. Clean
this part to prevent block and carryover.

Recommended Frequency: Every 2 week


Operator time: Approximately 3 minutes.
Precautions: /

Materials Required
Clean Gauze obtain locally
Distilled or Deionized Water -------
Chapter 9 Maintenance H100 Service Manual

sodium hypochlorite solution -------

Procedure:

1. Go to “System”— “Maintenance”.

2. Put 5ml 0.5% sodium hypochlorite solution in a tube. Put the tube in the STAT

position. Then executive the probe maintenance.

9.3. Monthly maintenance

1) Clean the Diluted Tank


Dilution is the place where the whole blood is diluted. Besides, waste will be
discharged through the dilution tank. It is suggested to maintain the cleanness of
dilution tank.

Recommended Frequency: Every month


Operator time: Approximately 3 minutes.
Precautions: Wear proper protective gloves; All power switches must be
OFF.

Materials Required
Clean Gauze obtain locally
Distilled or Deionized Water -------
0.5% sodium hypochlorite solution -------
Cotton Swab -------
Chapter 9 Maintenance H100 Service Manual

Procedure:

1. Use a cotton swab with 0.5% sodium hypochlorite solution to clean the dilution tank.

Then use a cotton swab with distilled water to clean the dilution tank.

2. Perform the “Diluted Tank Cleaning”.

2) Clean the Wiper filter


Wiper filter is the filter prevent the sediment get into wasted pump to damage it

Recommended Frequency: Every month


Operator time: Approximately 15 minutes.
Precautions: Wear proper protective gloves; All power switches must be
OFF.

Materials Required
Screw Driver -------
Distilled Water -------
Chapter 9 Maintenance H100 Service Manual

Procedure:

1. Use a cotton swab with 0.5% sodium hypochlorite solution to clean the dilution tank.
Then use a cotton swab with distilled water to clean the dilution tank.

2. Use a cross screwdriver to open the wiper filter, remove the diaphragm inside and
place it under running water to rinse.

3. Install back the filter and observe whether there is liquid leakage when the machine
is running.

9.4. Semestral maintenance

1) Clean the Pre-filter


Recommended Frequency: Every 6 months
Operator time: Approximately 3 minutes.
Precautions: Wear proper protective gloves; All power switches must be
OFF.

Materials Required
Distilled or Deionized Water -------
Wrench -------

Procedure:

1. Verify that the system is in standby state and enter the system operation interface.

2. Open the left door of the machine

3. Open the brown joint on the left side of the auxiliary pump of the high-pressure
pump manually.
Chapter 9 Maintenance H100 Service Manual

4. Use a wrench to open the connector and remove the prefilter.

5. If it is not very dirty, wipe with paper towel and rinse with deionized water;

6. Install the prefilter back to the auxiliary pump and twist the connector.

7. Start the high-pressure pump again for 1 minute, visually check whether the
pressure is stable and whether there is leakage in other joints.

2) Clean the Six-way Valve


Recommended Frequency: Every 6 months
Operator time: Approximately 15 minutes.
Precautions: Wear proper protective gloves; All power switches must be
OFF.

Materials Required
Internal hexagonal wrench -------
75% alcohol -------
Non-dust cloth -------

Procedure:

1. Power off the device. Open the front cover.

2. Unscrew the 5 hexagonal socket screws that fix the valve-head of the six-way valve.
Chapter 9 Maintenance H100 Service Manual

3. (Note: if necessary, unscrew the four M4*8 combination screws that fix the six-way
valve. But do not loosen the 6 stainless-steel joints on the steel stator);

4. Rinse the black rotor with a syringe (preferably 75% alcohol), and then wipe it dry
with a dust-free cloth (if you use tissue, dry it gently)

5. The stainless-steel stator should be wiped with a dust-free cloth and 75% alcohol,
and finally wiped with a dry dust-free cloth (if you use tissue, wipe it gently);

6. Install the rotor, and tighten the 5 hexagon socket screws of the stainless-steel
stator in the star-shaped sequence (1-2-3-4-5) as shown in the figure below.

3) Clean the Pre-filter


Recommended Frequency: Every 12 months
Operator time: Approximately 15 minutes.

Materials Required
Screw Driver -------
Distilled Water -------

Procedure:

1. Open the right cover of the device. Then find the waste filter.
Chapter 9 Maintenance H100 Service Manual

2. Use a cross screwdriver to open the waste filter, remove the diaphragm inside and
place it under running water to rinse.

3. Install back the filter and observe whether there is liquid leakage when the machine
is running.
Chapter 10 Trouble shotting H100 Service Manual

Chapter 10 Trouble shooting

10.1. Pressure too high

The pressure was created when the liquid arrives the column. The column will give
resistant force to the liquid and create the pressure. So, before the liquid arrives the column,
the pressure should be 0-1Mpa, because the filter will also create little pressure but not too
much. The flow speed of the instrument is 1.8mL ± 0.02mL/min. Follow the step show as
below and open the HP pump, when you found the certain point, its pressure is 0, and
previous point’s pressure is greater than 1Mpa, then there is crystal in the pipeline between
these two points.

Step 1: check the pressure and flow speed on


column’s liquid in side (the position show as picture
10-1 on the instrument), the pressure should be
0-1Mpa (Filter will create the pressure, and it is the
pressure of the filter if the pressure is 0-1Mpa), The
flow speed should be 1.8mL±0.02mL/min.

Picture 10-1
Step 2: Check the pressure and flow speed on
filter’s liquid in side (the position show as picture
10-2). The pressure should be 0Mpa and the flow
speed should be 1.8mL±0.02mL/min.

Picture 10-2
Step 3: Check the
pressure of the sample ring.
Remove the filter (same as
picture 10-3 shows) Open
the HP pump with SV19 for

Picture 10-3
Chapter 10 Trouble shotting H100 Service Manual

10 seconds to wait the pressure is stable, after that switch the status of six-way valve (Switch
the VICI status load and dis-pose as picture 10-3). In these two statuses, both pressures
should be 0. If the pressure in load status is 0 and dis-pose status is higher than 2Mpa, then
there is block in sample ring.

Step 4: Remove the


pipeline on the upper side of
pre-filter and test the flow
speed and pressure (the
position show as picture
10-4 shows), The pressure
should be 0Mpa and the flow
speed should be
1.8mL±0.02mL/min.

Picture 10-4

10.2.Pressure too low

Step 1: Check is there any leakage in the pipeline, and check did the evacuation valve is
close

Step 2: Remove the pre-filter to


test the pressure and flow speed from
HP pump, the reagent should come
out when you open the HP pump (the
position show as picture 10-5)

Step 3: Remove the one-way Picture 10-5


assembly on the upper side of the HP
pump, the reagent should come out
when you open the HP pump (the
position show as picture 10-6).

If the reagent come out in this


step and don’t come out in step 2,
please cleaning the one-way assembly
on the upper side (the connection of

Picture 10-6
Chapter 10 Trouble shotting H100 Service Manual

one-way assembly show as picture 10-7).

Picture 10-7

Step 4: Remove the connector show as picture


10-8, and set the AB reagent bag on the top of the
instrument. Switch the SV19 on and off, to check
whether the reagent was come out or not (there is
no need to open the HP pump). If the reagent come
out in this step and didn’t come out in previous step.
Please cleaning the one-way assembly on below of
the HP pump and HP pump head (the way how to
install the one-way assembly show as picture 10-9).

Picture 10-8

Picture 10-9
Chapter 10 Trouble shotting H100 Service Manual

10.3.Error Code E1

e1:Total area less than 50,000, for this sample, please load the sample in
anemia sample reck and test this sample again.

10.4.Error Code E2

e2:Total area more than 270,000; this is usually happened in column activation,
when this is happened in column activation’s diluted sample, please ignore it. If this
happened in whole blood sample, please test this sample as diluted sample. The
diluted rate for diluted sample is 10uL sample : 1500uL L reagent.

10.5.Error Code E3

e3:Result more than 15%; If sample test result report E3 error, then this sample
A1c result is more than 15%.

10.6.Error Code E4

e4:Result less than 4%; If sample test result report E4 error, then this sample
A1c result is less than 4%.

10.7.Error Code E5

e5:Variants detected; if the sample is report E5 error, please retest this sample
once again, and click the chromatographic in result interface, to check did
chromatographic is eluent variant peak.

10.8.Error Code E6

e6:ADC415 value reach max value during testing; please retest this sample, if
result is still reporting this error, please contact Lifotronic team.

10.9.Error Code E7

e7:A0 Total area less than 80%;

10.10. Error Code E8


Chapter 10 Trouble shotting H100 Service Manual

e8:Target peak is out of range; please follow column installation, set correct
column temperature show as column box.

10.11. Error Code E9

e9:Pressure is abnormal; please follow this chapter 10.1 and 10.2 to find the
blockage and leakage.

10.12. Error Code E10

e10:TP is too low, please check the column remaining test, and change the new
column in time.
Chapter 11 LIS communication H100 Service Manual

Chapter 11 Lis communication

B.1 LIS Communication Parameters

 Analyzer IP Address: 192.168.5.55


 Analyzer Port: 8000
 PC IP Address: 192.168.5.56
 TCP Communication Mode on PC: TCP Server
 TCP Port on PC: 8000

B.2 Communications Instructions

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

Error codes have the following meanings:


Code Meaning
0x31 E1 error code,Total area is less
than 50,000
0x32 E2 error code,Total area is more
than 300,000
0x33 E3 error code, Result is more than
Chapter 11 LIS communication H100 Service Manual

15%
0x34 E4 error code, Result is less than
4%
0x35 E5 error code, Variants are
detected
0x36 E6 error code,ADC415 value
reaches max value during testing
0x37 E7 error code,A0 Total area is less
than 80%
0x38 E8 error code, Target peak is out
of range
0x39 E9 error code, Pressure is
abnormal
0x40 E10 error code, TP is too low

B.3 Sample Data Format

Data start flag 【STX】


Data block specifier "S"
Version No. ##
Number of parameters ##
Parameter description format number ##
Code length ##
Sample ID. ###############
Test Temperature(T*10). ####
Sample rack position ##
Series No. ####
Blood type #
Year ##
Month ##
Day ##
Hour ##
Minute ##
Second ##
HbA1a appearance time ##
HbA1b appearance time ##
HbF appearance time ##
Chapter 11 LIS communication H100 Service Manual

LA1c appearance time ##


HbA1c appearance time ##
HbA0 appearance time ##
HbA1a absorbance #.####
HbA1b absorbance #.####
HbF absorbance #.####
LA1c absorbance #.####
HbA1c absorbance #.####
HbA0 absorbance #.####
HbA1a peak area ##.###
HbA1b peak area ##.###
HbF peak area ##.###
LA1c peak area ##.###
HbA1c peak area ##.###
HbA0 peak area ##.###
HbA1a peak area ratio ##.##
HbA1b peak area ratio ##.##
HbF peak area ratio ##.##
LA1c peak area ratio ##.##
HbA1c peak area ratio ##.##
HbA0 peak area ratio ##.##
HbA1c content in IFCC(mmol/mol) ###.#
Average blood glucose(mmol/L) ##.#
Average blood glucose(mg/dl) ###.#
Sent chromatographic curve number ###
Sent chromatographic curve values #.####
Test error code #
Data end flag 【ETX】
Chapter 12 Instrument packing H100 Service Manual

Chapter 12 instrument packing

12.1.Drain liquid line

Before you start packing the instrument, please empty the liquid line first. Press

“Empty liquid line” bottom in system -> maintenance interface, and follow the

guidance of instrument do the operation of empty liquid line.

12.2.Remove auto sampler

1. remove the fixture screws of STAT position’s protective cover.

2. Remove the STAT position’s protective cover


Chapter 12 Instrument packing H100 Service Manual

3. Remove the fixture screws of auto sampler’s front cover

4. Press the auto sampler’s back side fixture and take out the front cover

5. Install back 4 fixture screws of auto sampler inside and take out the auto sampler
Chapter 12 Instrument packing H100 Service Manual

from instrument

6. Install the ribbon of auto sampler shaker and install back auto sampler all cover

7. Take the instrument noumenon and auto sampler into instrument backage box.

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