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H618 HbA1c Analyzer

Operating/Technical Manual

Shenzhen Xilaiheng Medical Electronics Co., Ltd.

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Content

Chapter 1 Overview.......................................................................................................................1
Chapter 2 Product information....................................................................................................2
2.1Working principle.......................................................................................................................2
2.2 Main features.............................................................................................................................2
2.3 Product structure........................................................................................................................2
2.4 Reagents application..................................................................................................................3
Chapter 3 The equipment installation.........................................................................................4
3.1 Operating environment requirements........................................................................................4
3.2 Installation steps........................................................................................................................4
3.3 Installation inspection................................................................................................................5
Chapter 4 Operation......................................................................................................................6
4.1 Power on....................................................................................................................................6
4.2 Calibration.................................................................................................................................6
4.3 Sample testing............................................................................................................................7
4.4 QC............................................................................................................................................11
4.5 Setting......................................................................................................................................11
4.6 Review.....................................................................................................................................12
Chapter 5 Attention.....................................................................................................................13
5.1Attentions during operation......................................................................................................13
5.2Attentions while collecting and processing samples................................................................13
5.3 Attentions for Sample of serum and plasma............................................................................13
Chapter 6 Package, Storage and Transportation......................................................................14
6.1 Transportation..........................................................................................................................14
6.2 Normal storage conditions.......................................................................................................14
6.3 Special storage conditions and methods..................................................................................14
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Product information
Product model: H618
Product name: HbA1c Analyzer
Manufacturing site: No. B of 3/F, Xinghua Industry Building 7, Shekou Industry Road,
Nanshan District, Shenzhen 518066, China
Version information
This version is subject to change or upgrade without prior notice.
Version:
Issue date:
Declaration:
Shenzhen Xilaiheng Medical Electronics Co., Ltd. reserves the right to change the product
described in this Operating Manual.
All information contained in this Operating Manual is subject to change without prior notice.

Manufacturer’s Responsibilities
Xilaiheng Medical is responsible for the safety, reliability and performance of the device under
the following conditions:
1. Operating this device follows this Manual.
2. Assembling, upgrading, resetting, and repairing are performed by Xilaiheng’s authorized
personnel.
3. Product storing, operating and electrical environment are described in this manual.
4. Product serial number and labels are intact to verify the product identity as manufactured by
Shenzhen Xilaiheng Medical Electronics Co., Ltd.
5. Any damage that is not caused by miss-use or accidental dropping.
Free services apply to those products with applicable items within warranty period. For those
beyond the description of warranty conditions, Xilaiheng Medical will charge for service. Any
returned goods to Xilaiheng Medical for service, customers should pay for the transportation and
any applicable customs fees.
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Return Procedures
If return is necessary, take the following steps:
1. Obtain return merchandise authorization from Xilaiheng Customer Service Department.
2. Inform Xilaiheng of the serial number and mark this serial number on the cartons. If the
serial number cannot be recognized, the return cannot be accepted.
3. Describe briefly reasons for return.
4. Freight Charge: customer is responsible for freight charges (including customs) for any
returns.
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Chapter 1 Overview

H618 series of HbA1c analyzer, based on Affinity Chromatography and fluorescence

immunoassay technology by control of microcomputer, is a clinical testing equipment which is
rapid, accurate, convenient, practical.
Hemoglobin (Hb) is composed by a variety of sub-components and derivatives. Therefore, a
variety of glycosylated hemoglobin (GHb) produced after scarification is collectively referred to
as HbA1. HbA1 is a mixture with subtypes such as a, b, c and d. HbA1c constitutes the majority
and the most stable part of it. HbA1c is formed during non-enzymatic reaction in glucose and
adult's Hb (HBA) of amino-N-terminal (B link) through two steps.
The first step is reversible and produces unstable HbA1c, after which it will slowly change
into the stable HbA1c during the second-stage reaction. The relative proportion of HbA that
changes into stable HbA1c will increase with the average blood glucose concentration in
erythrocytes. As erythrocyte's life cycle is about 100-120 days, HbA1c can reflect the average
blood glucose levels within the last 2-3 months. Therefore, HbA1c is also suitable for long-term
monitoring of blood sugar levels for the patients of diabetes. In case of serious metabolic
disorder, the risk of the occurrence of diabetic complications (such as diabetic nephropathy and
retinopathy) will be increased accordingly.
As an indicator of average blood sugar levels, HbA1c can predict the risk of diabetes
complications. For clinical routine examination, it is sufficient to have HbA1c examination every
3-4 months. In some cases, such as in pregnancy or major change for treatment programs, it is
very helpful to have HbA1c examination once every 2-4 weeks.

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Chapter 2 Product information

2.1 Working principle

H618 analyzer is based on the principle of affinity chromatography. On the basis of this
principle, the blood cells will be rapidly pyrolyzed and release the hemoglobin after mixing the
test sample with the hemolysin. When the hemolysis sample is dropped to the detection area, it
can adsorb chemically the glycosylated hemoglobin from the sample that has been dissolved
with the hemolysin under the condition of the pH value of the eluent B. Through the 430-nm
illuminant of the analyzer, quantitative detection of hemoglobin is taken by use of 415 nm
absorbance peak. At the same time, the light reflected in the test strip surface can be detected by
the photodiode where the reflected light value has a direct and certain proportion with the
glycosylated hemoglobin concentration of the sample.

2.2 Main Features

a) Measuring method: Affinity Chromatography
b) Test parameters: HbA1c, eAG
c) Sample type: Whole blood or peripheral blood
d) Measuring range: HbA1c 4.0%-15.0%
e) Test time: 3-5 minutes
f) Display: LCD display
g) Dimension：205×130×70mm，1Kg
h) Power：AC100-240V,50/60Hz，60VA
Internal battery optional 12V, 2600mAh

2.3 Product structure

H618 Series HbA1c analyzer is composed of microprocessor, LCD display, light source, light
receiving system, RFID receiving system.
All the operations are applied for man-machine touch communication.

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2.4 Reagents application

H618 Series HbA1c analyzer reagents contains hemolytic A and eluent B. The reagents of
H618 series is used only as In Vitro Diagnostic reagents. Reagent should be stored at room
temperature 18℃ -25℃, can be cold, but not frozen. If out from the fridge, should be placed more
than 30 minutes, temperature should up to room temperature before using. All the
reagents should be used within the period of validity.

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Chapter 3 The equipment installation

3.1 Operating environment requirements

Environment temperature: 10℃-30℃

Power voltage: AC100-240V, 50/60Hz, 60VA, internal battery is optional 12V
Relative humidity range: ≤80％
Keep away from strong electromagnetic interference source.
Avoid direct light exposure.
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The equipment must have good grounding.

This equipment should not be put in the same room or with same power supply socket such

as centrifuge, refrigerator, oven, large power and large jamming equipments.

Ventilation requirements:
The instrument should be placed in good ventilation indoors.
Placement should be avoided fan, air conditioning and other direct blowing instrument, so as
not to affect the precision of temperature control.
Strong vibration should be avoid during working process.

3.2 Installation Steps

1. Open the instrument package first, please follow the packing list at the end of operation
manual to check if listed component is complete and check if there is damage of
components due to improper transportation.
2. If there is any damage during transportation, please immediately notify the supplier.
Attention: If equipment is damaged, do not use it to ensure safety.

3. If any problems, take out of the equipment carefully; put it in the working table smoothly.
4. Installation of printer: This product uses external printer. Connect interface 1 to the back
of the instrument on the 232-2 interface, connect the plug 2 to power supply.

3.3 Installation
inspection
1. After turning on the
power, equipment will
be self-checking, and
then to standby.
2. Enter to each menu

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to operate according to the operation steps to make sure every step is works normally.
3. Using QC solution to do the test, if result meets the demand, the equipment is qualified.

Chapter 4 Operation

4.1 Power on
Turn on the power switch ， system will be preheating. The main menu will be showed as
follows.

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4.2 Calibration
Press the “Cal” button，system will show as follows:

Put the RF card onto the zone，press “Read”. The read position is showed as below：

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4.3 Sample testing

Sample tests for
H618 Analyzer can
be divided into 2
kinds of testing
mode--- 'Need not reading blank' & 'Need reading blank'. Compared with 'Need not reading
blank', 'Need reading blank' can make sure the stability and precision of results but spend more
time. On the contrary, under 'Need not reading blank' mode, testing speed can be faster but the
results will be less stable and precise. It depends on the choice of the user.
Preparation for ‘Need not reading blank’ (see ‘setting menu’)
1) After reading the card, press “Test” button and the screen will show as below.

Add sample (10ul blood) into the hemolytic (50ul) and mix to standby. Get 3ul sample
out and press” Start” button.

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2) Drop 3ul sample to the right position of cartridge and insert it into the instrument.

3) When the warning tone sounds again, drop the eluent B (35ul) to the left position of
cartridge and wait.

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4) Wait for 200 seconds, system calculates the testing result automatically, the value of HbA1c
and eAG. The screen displays as follows. Click “New” to start a new sample.

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Preparation for ‘Need reading blank’ (see ‘setting menu’)

1) After reading the card, press “Test” button and the screen will show as below.

Insert a new cartridge. then add sample (10ul blood) into the hemolytic (50ul) and mix to
standby. Get 3ul sample and press” Start” button.

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2) Drop 3ul sample to the right position of cartridge and push it back into the instrument.

3) When the warning tone sounds again, drop the eluent B (35ul) to the left position of
cartridge and wait.

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4) Wait for 200 seconds, system calculates the testing result automatically, the value of HbA1c
and eAG. The screen displays as follows. Click “New” to start a new sample.

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4.4 QC
Click “QC” in the main menu to enter the interface of QC, screen display as follows.

You can
modify the
QC value,
print QC
chart, and
do One-
point and
Two-point
correction from this page.
4.5 Setting
Click “Set” in the main menu to enter the interface of Setting

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If you
need to set
the time,
click "RT
C" button
. Click
"save” to
complete
the setting.

To modify
system
time pleas
e click the
part
of gray sh
adow.

4.6 Review
If users need to view the history test records, click on “Data” in the main menu. The screen
displays as followings.

Input the
testing
time of the
sample
you want
to check,
then click
“Query”
to find the testing result.

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Chapter 5 Attention

5.1 Attentions during operation

1.1 Pay attention not to absorb coagulated blood, to prevent blockage of pipeline.
1.2 Do not to absorb bubbles, which may affect the precision of test result.
1.3 Do not use solution with mildew and precipitate, should be abandoned once be found.
1.4 All the reagents should be tightened immediately after taking, avoid long time open
placed.
1.6 This instrument do not contain any component capable of self-repair, do not disassemble
it when break down.
1.7 Ensure the power supply environment and ground environment are of good stability.
5.2 Attentions while collecting and processing samples
Sample collecting and processing should be done by professional persons, to avoid affect of
rest result.
5.3 Attentions for Sample of serum and plasma
1．Serum and plasma refrigerated can be analyzed, but make it back to room temperature
before testing.
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2．When making the serum sample, some materials which may affect test result can not be
added ( such as surface active agent, anti-coagulant, ect,) it may disturb the test and even damage
the sensor.

Chapter 6 Package, Storage and Transportation

6.1 Transportation
During transportation, the instrument should be kept away from rain, snow and mechanical
collision, and should not be mixed with or transported together with corrosive substances.
Simple shockproof facilities should be set up in the packing case, making it suitable for air, rail,
highway and sea transports. Rain and snow splash, inversion and collision should be avoided.

6.2 Normal storage conditions

The instrument should be stored in a place or warehouse that satisfies the following conditions.
Ambient temperature: 0-40℃; relative humidity: ≤80%; Clean and ventilated; sunshine, rain and
hazardous gases with chemical corrosion can be avoided.

6.3 Special storage conditions and methods

When the device has been stored for more than 6 months, it should be taken out from the packing
case and energized for 4h; then put the instrument in the packing case again according to the
direction shown on the case and place it in the warehouse. Do not stack up instruments, and do
not place them close to the ground, walls and roof.
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