【Zybio】IFU-Lepgen 96

Full automatic medical PCR analyse system (Model:Lepgen 96) Operating Specification
Full automatic medical PCR analyse system

(Model:Lepgen 96)
Operating Specification
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Content
1 Full automatic medical PCR analyse system introduce..................................................................5
1.1System description........................................................................................................................5
1.1.1Product summary........................................................................................................................5
1.1.2Product performance..................................................................................................................5
1.2Application range..........................................................................................................................9
1.3Application crowds.......................................................................................................................9
1.4 Main structure form.....................................................................................................................9
1.5 Product package list.....................................................................................................................9
1.6 Panel profile...............................................................................................................................10
1.6.1Front panel profile....................................................................................................................10
1.6.2Sample pool profile..................................................................................................................10
1.6.3Rear panel profile.....................................................................................................................11
1.7 Full automatic medical PCR analyse system working, transporting and storage condition......11
1．8 Fittings list.................................................................................................................................12
2 Installation of full automatic medical PCR analyse system..........................................................12
2.1Installation environment requirements........................................................................................12
2.2System installation......................................................................................................................12
2.2.1Power supply connect wire installation...................................................................................12
2.2.2Software installation................................................................................................................13
2.2.3Drive installation.....................................................................................................................16
2.2.4Software uninstall....................................................................................................................17
3 Full automatic medical PCR analyse system operating introduce................................................18
3.1Experiment design.................................................................................................................... 18
3.1.1Sample preparation................................................................................................................. 18
3.1.2Create experiment..................................................................................................................18
3.1.2.1Basic setting.........................................................................................................................19
3.1.2.2Plate holes edit.....................................................................................................................20
3.1.2.3 Sample information.............................................................................................................21
3.1.2.4Experiment running...............................................................................................................22
3.1.2.5Experiment analyse...............................................................................................................24
3.1.3 Running last time experiment...............................................................................................26
3.1.4 Open experiment.....................................................................................................................27
3.1.5 Running quick experiment......................................................................................................27
3.2 Project setting............................................................................................................................28
3.2.1Project management.................................................................................................................28
3.2.2 Create project..........................................................................................................................30
3.2.3 Project output and input.........................................................................................................35
3.3 Software application..................................................................................................................35
3.3.1Qualitative/Absolute quantify..................................................................................................35
3.3.1.1Qualitative/Absolute quantify experiment process...............................................................37
3.3.1.2Qualitative/Absolute quantify experiment analyse...............................................................40
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3.3.2 Standard melt curve experiment.............................................................................................42

3.3.2.1Standard melt curve experiment process..............................................................................42
3.3.2.2 Standard melt curve analyse................................................................................................44
4 Warning, notices and contraindication..........................................................................................44
4.1Operating notices........................................................................................................................44
4.2 Power supply voltage, connection and grounding.....................................................................44
4.3 Operating process of full automatic medical PCR analyse system............................................45
4.4 Contraindication.........................................................................................................................45
5 Failure appearance and handle......................................................................................................45
6 Repair, clean and maintenance......................................................................................................46
6.1 Repair and calibration................................................................................................................46
6.1.1Repair.......................................................................................................................................46
6.1.2Calibration................................................................................................................................47
6.2Clean and maintenance of full automatic medical PCR analyse system....................................47
6.3 Renewal fuse.............................................................................................................................47
6.4 Other notices.............................................................................................................................47
7 Medical treatment apparatus label used figure, symbol and abbreviation instruction..................48
8 Electromagnetic compatible(EMC) instruction ...........................................................................48
8.1 Electromagnetic radiation..........................................................................................................49
8.2 Electromagnetic disturb.............................................................................................................49
8.3 Calculating the interval distance between communication equipment and system...................50
8.4 Interval distance between communication equipment and system...........................................51
9 Electric safety..............................................................................................................................52
10 Manufacture information...........................................................................................................52
Appendix 1: Patient report format template...................................................................................54
1Patient report manage device.......................................................................................................54
2 Newly create patient report template..........................................................................................54
3 Patient report template setting.....................................................................................................57
Appendix 2: Software reminding error information summary.......................................................59
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Specification Introduce
The full automatic medical PCR analyse system specification introduce formed with the below
parts:
•Introduce: overall introduce full automatic medical PCR analyse system
•Install operation: guide users process each part installation of full automatic medical PCR analyse
system;
•Test and setting:guide users process test and setting full automatic medical PCR analyse system;
•Warning, failure and maintain: guide maintain full automatic medical PCR analyse system,
handle the common failure and warning introduce label and manufacturer information.
Attention the notices under this mark.
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1 Full automatic medical PCR analyse system introduce

1.1System description
1.1.1Product summary
Full automatic medical PCR analyse system used to process real time PCR (Real time PCR)
experiment and analyse the experiment data. The instrument assisted by the corresponding reagent
to make the target ribotide of test object generate expansion increase and melt appearance and
represent assisted by fluorescence type. Realize the qualitative and quantify judge the target
ribotide through analyse the fluorescence signal which generated in the experiment, or process
corresponding research at melt curve and gene parting at target ribotide.
The working principle of full automatic medical PCR analyse system is make the probe which
marked fluorescence perssad mix with unknown gene template, finish high temperature
denaturation, low temperature renaturation, heat circulating at suitable temperature extension, and
follow the polymerize ferment chain reaction rules, the probe which complementary pairing with
unknown gene template been cut off, fluorescence perssad dissociate in the reaction system, send
out fluorescence under special light excited, the expansion increased target gene part present index
regular increasing along with the increasing circulate times, the fluorescence strength of reaction
system also corresponding strengthen. Get Ct value through real time test and the corresponding
fluorescence signal strength, at the same time, utilize several known gene template concentration
standard product produced the standard curve to process quantify analyse the gene template then
can the copied number of target gene of waiting test sample.
The main application of this instrument is used in clinical lab to utilize the fluorescence
polymerize ferment chain reaction method to qualitative or quantify analyse multiply gene.
1.1.2 Product performance
Temperature control
1）Temperature rising speed
The average temperature rise ratio:from 48℃ to 90℃, shouldn’t lower than 1.5℃/s.
2）Temperature reduce speed
The average temperature reduce ratio:from 90℃ to 50℃, shouldn’t lower than 1.5℃/s.
3）Module temperature control precision shouldn’t bigger than 0.5℃
4）Temperature accuracy
The absolute value between measure value and setting temperature difference shouldn’t bigger
than 0.5℃.
5）Module temperature uniformity
The temperature difference should be in ±1 ℃ range.
6）Temperature continuation time accuracy
The opposite deviation between temperature continuation time and draw up temperature time in
the ±5% range.
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The fluorescence strength test

1）The fluorescence strength test repetitiveness
Use each high, middle and low concentration calibrate colorant repeat test, it’s variation
coefficient (CV%) shouldn’t bigger than 3%.
2）The fluorescence strength test density
Randomly select 10 pieces test holes in the instrument test range, use each high, middle and low
concentration calibrate colorant repeat test, it’s variation coefficient (CV%) shouldn’t bigger
than 3%.
3）The fluorescence disturb in different passageway
The intersecting disturb in the fluorescence passageway of other passageways lower than 1.00%.
Sample test repetitiveness
Test high, middle and low concentration ribotide sample, CV of Ct value (or concentration
logarithm value) shouldn’t bigger than 3%.
Linear
1）Sample linear
Test series thinning gradient concentration samples (5 gradient), the absolute value of linear
regression coefficient r between each concentration Ct value and concentration logarithm value
not lower than 0.980.
2）The fluorescence linear
Test series thinning gradient concentration samples (5 gradient), the absolute value of linear
regression coefficient r between each concentration fluorescence test value and thinning ratio not
lower than 0.990.
Appearance
a) The figure symbol on the panel and words need correct, clear and even, can’t has scratches;
b) The fasten parts connection should be firm and reliable, can’t loosen;
c) The motion parts should be stable, shouldn’t blocked, suddenly jump and obvious empty back,
key group return jump should be flexible.
Common requirements of software
1Handle objects
Real time fluorescence PCR experiment data
2The max complication number
The mas complication users number:1
3Data interface
The data interface of full automatic medical PCR analyse system is RS232 series.
4Special software and hardware
Windows office Word/Excel 2007-20 16 version.
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5 Clinical function
The main function of software mainly include two major items: experiment design and project
setting.
A.Experiment design
The experiment design include create experiment (experiment guide), running last time
experiment, open experiment and running quick experiment.
1）Create experiment (experiment guide): guide users to create one new experiment. Include the
below functions:
Basic setting: display equipment information, set experiment information and equipment setting;
Hole plate edit: include three steps at select reaction hole, select project and define reaction hole;
Sample information:the information of sample which input the reaction hole;
Experiment running: real time monitor and collect the experiment data;
Experiment analyse: check and analyse experiment result, experiment data output and print patient
report
2）Running last time experiment: running one experiment, all settings on this experiment
accordance with the last time running experiment of user;
3）Open experiment: open one already ran experiment file and process analyse;
4）Run quick experiment: quickly running one experiment.
B.Project setting
The project setting include output and input project management device, create project and
project.
1）Project management device: manage all created experiment projects in the management system
(edit, rename and delete one special project);
2）Create project: create one new project. Include the below functions:
Basic information: set the information of project, include: project name, project type, reaction
system, unit, remark information, test target;
Experiment procedure: edit the experiment procedure;
Experiment parameters: modify the basic parameters, fix quantity test range and intersecting
disturb coefficient.
3）Project output and input: input the early saved well project document into software system,
provide to use in the experiment; output the saved well experiment project to the appointed
catalog at the document type, convenient for save and quote this experiment project.
6 Use limit
(1)The range of sample reaction system is 15 ~100 microlitre;
(2)The temperature setting range of experiment procedure is 4.0-99.0°;
(3)The duration time of temperature range is 00:00 ~99:59;
(4)The running section of experiment procedure max 9 pieces, the max in each running period has
9 steps;
(5)Each running period max set 99 pieces circulating;
(6)Each running period only has one step can set at the step of fluorescence test, and temperature
duration time of this step must bigger than 14S, the sum circulating times of all running period
need bigger than 3 times;
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(7)The start point range of datum line:1~(datum line end point-1); the datum line end point
range:(datum line end point+1)~set the sum circulating times of all running period.
7 User visit control
The user can directly visit the software, needn’t verify identification.
8 Copyright protection
The software sales along with equipment at disc type, the installation of software need use the
provided serial number. Can indefinite duration use after software installed, no limit at use time
and use time.
9 User interface
Menu interface: icon menu, text and icon mixed menu;
Dialogue interface: must reply type and warning type;
Data input interface;
Data display interface
10 Message
The message type of software shown as below:
Common reminding message:must input data then can process the next step reminding message
(during project setting, must input test object fist then can edit experiment procedure), delete
reminding (delete project), file change save reminding when closing, withdraw reminding.
Error reminding message: communication error reminding, heat cover not push on position
reminding.Equipment status information: it will real time display current real time temperature,
real time fluorescence data and current running status and running time during running the
experiment.
11 Reliability
1） The software process the reliability protection at error of user input boundary value and
semantics.
The software process recover protection at user abnormal operation error:
2）If forced to close the software (interrupt process or computer power off) during running the
experiment, the user can select whether continue running after restart software.
If plug off the series wire during running the experiment, the user can select whether continue
running after connect the communication again.
3）The user data can output and backup any time.
12 Maintain performance
PCR host computer provide maintain information through log daily record type, the log daily
record at the log document folder in the software root catalogue, log document name is
LogXXXXXXXX.txt (XXXXXXXX is the daily record generated data,
example:Log20160817.txt, represent the log information in the day of August 17th, 2016).
The log content include the below information: experiment record calling information (include
experiment record name and calling time), the time of newly created experiment, the time of start
and finish experiment, communication and equipment abnormal information (include
communication abnormal information).
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13 Efficiency
During the experiment running process, the real time temperature data and fluorescence signal
data (example test fluorescence) receive time interval not bigger than 150ms. The time from
communication broken to reminding error not exceed 18s.
14 Running environment
1）Hardware configuration
Processor: Intel or AMD double core 2.8GHz
Memory: above 4G
Hard disk capacity: above 128GB
Outer terminal: USB terminal
2）Software environment:
System software: Windows 7 (32bytes)/8(32 bytes)/8.1(32bytes)
Quality requirements
Are in accordance with requirements in Chapter 5, GB/T 25000.51
1.2 Application range

This product based on polymerize ferment chain reaction principle (PCR) and real time
fluorescence monitor technology, mutually use with the assorted reagent, process qualitative or
quantify test or dissolve curve test the analyse material ribotide sample (DNA/RNA) from human
body on clinical, include pathogenicity pathogen ribotide, human gene and other projects.
1.3Application crowds
Target patient crowds: the clinicians regarded adult, children or neonates who need process real
time fluorescence PCR test.
Patient select standard: need patient provide enough clinical sample to meet test requirements.
1.4Main structure form

This product formed with control module, power supply module, temperature control module,
light path test module, outer shell module, heat cover module, support module, host computer
software (version V2) of full automatic medical PCR analyse system and imbed type software
(version V1).
1.5Product package list

Product package list
Package assembly Assembly number
Full automatic medical PCR analyse system 1
(Model:Lepgen-96)
Power supply wire 1
USB adapt series wire (USB-9 needles) 1
Maintain guarantee card 1
Operating specification 1
Air blow ball (option) 1
Software install disk 1
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Fuse(Φ5*20mm, 10A,250V) 2
Qualification certificate 1
Loading list 1
1.6 Panel profile

1.6.1Front panel profile
The front panel diagram as below:
The running indicate lamp
The power supply indicate lamp

The test indicate lamp
Picture 1-1 Front panel

Shown as the picture 1-1, the power supply indicate lamp lighting when instrument start; the
running indicate lamp will open when finish edit experiment running, extinct after program
running finished; the test indicate lamp will lighting when each time fluorescence testing, the test
indicate lamp will extincted when fluorescence test finished. The running indicate lamp will
normally lighting during the whole procedure running process, the test indicate lamp will some
time lighting some time extinct along with the test period.
1.6.2 Sample pool profile
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Picture 1-2 Sample pool

Shown as the picture 1-2, the instrument test adopt warm bath and fluorescence test, the sample
pool total has 96 pieces trial pipe hole positions, each hole position all will process the
corresponding rise temperature, constant temperature and reduce temperature process along with
user edited temperature procedure. Each hole position also will process different passageway test
along with the edited temperature procedure. Attention the temperature in the reaction pool maybe
higher when experiment finished, the user should attention at prevent scald when pick and place
sample.
1.6.3 Rear panel profile
The rear panel include: power supply socket, switch, fuse, COM1 port, COM2 port.
Among, the power supply socket, switch and fuse are uniform type, used in start and close the
equipment power supply.
COM1 port can outer connect LIS system.
Picture 1-3 Rear panel
1.7 Full automatic medical PCR analyse system working, transporting
and storage condition

Specification introduce
Power supply AC220V～、50Hz
Input power 800VA；
Size 490mm x355mm x284mm；
Weight 20Kg；
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Working condition 1) Temperature: 10～30℃

2） The relative humidity: <85%；
3） Atmosphere: 78.9 kPa～101.3 kPa
Storage condition Storage temperature: -20℃~55℃, The relative humidity: ≤90%, no corrode gas, in
better air venting environment.
Transporting condition Transporting temperature: +10℃~+40℃, The relative humidity: 0%~75%, should
prevent seriously impact, shock, raining and sunshine.
1.8 Fittings list

Fittings Quantity Remark
Power supply wire (3GTJ1+3GTJA 1 Purchase according to specification and model ff damaged.
10A 250V～)
USB adapt series wire (USB-9 1 Purchase according to specification and model ff damaged.
needles)
Air blow ball (option) 1 Self purchase if damaged.
Software install disk 1 Please contact manufacturer for it if damaged.
Fuse（Φ5*20mm，10A，250V） 2 Purchase according to specification and model ff damaged.
2 Installation of full automatic medical PCR analyse system

2.1Installation environment requirements
◆ Hardware environment requirements:
1）PCR equipment main machine must level and firm on the working platform surface, at the same
time, avid sunshine, far away heating equipment, far away powder dust;
2）The equipment main machine keep above 12cm distance with the around objects to guarantee
the equipment air venting and heat radiation normally running, at the same time, convenient for
user start and close instrument power supply or connect the computer and other equipment;
3）The equipment should far away the instrument which has strong electromagnetic disturb or has
high sense coefficient, example high speed centrifuge machine and oscillator, etc.
◆ Software environment requirements:
1）Hardware configuration
Processor:Intel or AMD double core 2.8GHz
Memory: above 4G
Hard disk capacity: above 128GB
Outer set terminal: USB terminal
Note: if hardware configuration lower than above requirement then will affect the software
operating efficiency and user experiment.
2）System software: Windows 7/8/8.1, 32bytes version.
Special software:Windows office Word/Excel 2007-2016 version
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2.2 System installation

2.2.1 Power supply connect wire installation
1） Pick out the power supply connect wire which configure along with machine from the
package box;
2）Inset one end of power supply connect wire into the outer power supply with grounding
protection;
3）Insert another end of power supply connect wire into the power supply joint which behind the
full automatic medical PCR analyse system;
4）Make ensure the power supply switch of full automatic medical PCR analyse system be at
broken status during installation process.
2.2.2 Software installation
1) Read software installation disk, open the Zybio full automatic medical PCR analyse system
installation folder in the disk.
2) Double click “ Zybio full automatic medical PCR analyse system software (version number:
2.0.2.6) installation folder\Setup Files\Zybio full automatic medical PCR analyse system software
(version number: 2.0.2.6) installation folder.exe” file, jump out the installation dialog box, shown
as the below picture:
Picture 2-1
3)Click “Next step”
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Fill user name, organize and product serial number (the product serial number in the installation
folder license.txt file), click the next step
Picture 2-2
Click “View”, select the software install catalog, generally, keep default catalog the OK.
4）Click “Next step”
Picture 2-3
5）Click “Installation”, occur the below installation interface and waiting installation finished then
OK.
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Picture 2-4
Picture 2-5
6）Click finish then OK, now, software installation finished.
Note:
Windows 7 and above system need running software through administrator identification, the
operation as below: table software icon right key->property->compatibility
Will tick before “Running this procedure through administrator identification”, click to confirm.
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Picture 2-6
2.2.3Drive installation
1) First, the series not connect computer
2)Double click “ Full automatic medical PCR analyse system 2.0.2.6 installation
folder\Drivers\ZybioUSBInstaller.vbs”file, jump out the below window:
Picture 2-7
Click confirm then occur the below interface:
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Picture 2-8
3）Connect USB wire to computer, click “Confirm”, waiting till drive installed successfully,
shown as the below picture.
Picture 2-9
2.2.4 Software uninstall
1）Close Zybio f ull automatic medical PCR analyse system software
2）Click Windows “Start” menu->All programs->Full automatic medical PCR analyse system
software 2.0.2.6->uninstall Zybio f ull automatic medical PCR analyse system, shown as the
below picture:
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3）Select “Yes” in the pop out window, shown as the below picture:
4）Waiting uninstall finished then OK.
3 Zybio full automatic medical PCR analyse system operating introduce

Connect the power supply connect wire of full automatic medical PCR analyse system to the
220V socket, close the power supply switch at the same time, open full automatic medical PCR
analyse system. The equipment enter into Windows system interface after start machine, open
Zybio full automatic medical PCR analyse system software to test. The so ftware main menu
interface formed with two module group at experiment design and project setting. The operating
procedure of Zybio full automatic medical PCR analyse system as below:
3.1Experiment design
3.1.1 Sample preparation
Matching according to the specification of reagent and dop the matched well solution sample into
reagent pipe, and tightly covered the reagent bottle cover, required the sample capacity in the
reagent pipe bigger than 15uL. Put the sample into sample pool of equipment.
3.1.2 Create experiment
Open Zybio full automatic medical PCR analyse system software and enter into the software main
interface, shown as the below picture 3-1.
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Picture 3-1 Main interface

Experiment guide: can easy and convenient to create one experiment according to guidance
Click “Experiment guide” on the main interface and enter into experiment guide interface, the
experiment guide conduct users create one new experiment through flow chart type, and process
experiment running and analyse.
3.1.2.1 Basic setting
The basic setting mainly used to edit and display the basic information of experiment and
instrument setting information. Shown as the below picture:
Picture 3-2 Experiment basic setting

Equipment information: display the current equipment model and equipment number.
Experiment name:default as experiment create time (default format is
year-month-day-hour-minute-second), the users can click here to edit according to requirements.
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Save pathway:the experiment document save pathway can be click “View” modified by users
according to requirements.
Experiment types: can select the suitable experiment types in the drop-down menu, can select
“qualitative/Absolute quantify” and “Standard melt curve”.
Operator and auditor: optionally fill
Heat cover setting: if select “Use heat cover” then the heat cover temperature will be maintain at
105℃ during experiment; if not select use heat cover then must cover olefin oil on the reagent,
avoid the reagent solution evaporation and condensation caused error experiment result.
Passageway scan setting: select “only scan project selected passageway” means the optic system
of instrument process passageway scan according to experiment project setting, not configured
passageway in project document not process scanning; “Full passageway scan” means optic
system scanning equipment’s 4 passageways during experiment.No matter select “only scan
project selected passageway” or select “Full passageway scan”, the software displayed expansion
increase curve and original curve all are only corresponding to the colorant passageways which set
in the project, example, the setting in project is FAM passageway (first passageway), the software
displayed expansion increase curve and original curve only display FAM passageway. Default as
“only scan project selected passageway”.
3.1.2.2 Plate holes edit
Click “Plate hole edit” option card, enter into plate hold edit interface (Picture 3-3). Select the
pending edit holes in “Step1: select reaction hole” interface. If has multiply pipes sample then
need select the reaction holes at least bigger than the multiply pipe number at the same time.
Plate hole edit mainly edit and display the reaction hole information, include calling project and
define the reaction holes property, etc.
Picture 3-3 Plate hole edit

1）Select the reagent corresponding reaction holes at “Step1: select reaction hole” option card, the
background of selected reaction hole change to be deep gray.
Can single click 1 piece reaction hole on the reaction hole plate, also can press ctrl key and click
multiply reaction holes at the same time, can select non continuous multiply reaction holes, also
can use mouse drag to select the corresponding are on the reaction hole plate, press direction key
can process up, down, left and right movement.
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2）The user select the tested items on the “Step 2: select project” optional card.
The project list displayed the project information which saved in the software by users. If project
list no user required project information then need contact the reagent manufacturer’s technical
service staffs, or create the project according to clause 3.2 in this specification.
3）Can click the corresponding projects on the “Step 3: define reaction holes” optional card,
modify the sample types, property, sample name, set at combine pipe and combine pipe number.
The user can select the suitable sample types (pending test sample, standard products, positive
contrast, critical positive contrast, negative contrast, no template contrast, calibrated sample and
re-test sample) in the “Select sample types” drop-down menu.
The user can modify the sample’s property information according to requirements in the “Property”
frame.
Select reaction hole and click the “Delete” option on the top of interface, or right key “Delete
sample” then can delete the selected reaction holes.
If need define combine pipe, select “Set as combine pipe” tick frame and input combine pipe
number. If the same concentration reaction materials which react in several reaction holds then
can set these several reaction holes as combine pipe.
Note: the sample types and property information maybe different under different experiment
modes. The details please reference 3.3 software application.
3.1.2.3 Sample information
Mainly used in the patient information of sample which user input into reaction holes, example:
name, sex, ages, number and other information. The patient information represent through table
type.
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Picture 3-4 Sample information

Note: the unique mark used in the unique mark sample, help users discriminate different samples.
3.1.2.4Experiment running
Main function: start running experiment, monitor and collect the real time data to display on the
interface.
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Picture 3-5 Experiment running
Click the “Start” option on the menu column, the experiment start running (imitate
mode unable to start experiment). The up left corner of experiment running interface displayed the
temperature procedure, temperature tendency and status information,
The down left corner displayed the real time fluorescence curve, include expansion increase curve
and original curve.
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Note: if occur abnormal situation caused experiment interrupted (example suddenly power off, etc)
during experiment, it will pop out dialog frame and ask whether continue running from the broken
points after restart software. If select continue running from the power off position then the
experiment will call out the last time interrupt data and continue running, this operation maybe
caused unsatisfied experiment result.
3.1.2.5 Experiment analyse
It will automatically jump to the experiment analyse interface after experiment running finished or
open one experiment record document.
A. Check and analyse experiment result
Right side of interface are reaction hole information table, basic parameter setting and hole plate
selector respectively; the left side is standard curve, experiment procedure, expansion increase
curve and original curve, the user can check the corresponding reaction curve through select some
reaction holes.
Picture 3-7
“Hole plate information table” form and left side window will display the selected sample data
information and curve information after select all or partial sample on “Hole plate selector”.
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Sample, curve or data can link display, the relate all information of this information will process
heavier emphasis display when the user hovering the mouse at above of one information, and, it
also display the detail information of this curve when user hovering the mouse at above of curve.
Right key click the curve to select “Save picture...” can make the current curve will save at the
special format (BMP and JPG).
Right key click the curve to select “Copy picture” can make the current curve form picture and
save to the shearing plate, used in the file edit and other operations.
Right key click the curve to select “Output data...” can make the current curve’s data to save
through the Excel file type.
B. Output experiment data
Click the “Experiment data” in the “Output” option at the top of interface, output the
current file data. The output file format are xlsx, csv or txt.
The user can self define what output data, the down table displayed the output content, different
analyse types can output item maybe different.
Basic information: experiment name, experiment type, auditor/operator, passageway scan setting
information
Reaction hole information table: all information in the reaction hole information table
Expansion increase curve: the expansion increase curve data of all samples
Standard curve: standard product and standard curve information (only exist in the absolute
quantify analyse)
Click the “Quick experiment” menu in the “Output” menu, output the current experiment
as quick experiment. Input document name and confirm in the pop out frame (as the below
picture), means set the current experiment document as quick experiment. The user also can input
the remark information of experiment in the full name or remark frame.
C. Print the patient report

Select waiting print sample on the reaction hole selector, click the “Patient report” in the “Printing”
option at top of interface then pop out print patient report dialogue box. Shown as the below
picture:
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Click “Print” and print the selected all reports; click “Print current page” and print the preview
report; click “Up page” or “Down page” to check the report.
Note: (1) only the sample type are “Waiting test sample/re-test sample” reaction report then can
print patient report.
(2)About the “Newly create patient report template, edit patient report template, patient report
template manager and patient report setting” function which contain in the “Print” option at top of
interface, the details check appendix 1.
3.1.3 Running last time experiment
Click “Running last time experiment” option to running one experiment in the main interface, all
settings of this experiment same to user’s last time running experiment.
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3.1.4 Open experiment

Click “Open experiment” option card in the main interface, can open one experiment file which
already finish running, directly process experiment analyse.
3.1.5 Running quick experiment

Single click any one quick experiment in the quick experiment area in the main interface, can
quickly running this experiment, shown as the below picture.
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3.2 Project setting

Experiment project document is the special experiment configure document in the full automatic
medical PCR analyse system software, it contains all experiment setting information except the
hole plate setting, means passageway information, PCR expansion increase procedure and
experiment parameter, etc. Draw up the project document based in the reagent specification, it
provide mostly big convenience for users, the user can create or edit projects according to reagent
specification, also can contact reagent manufacturer to obtain project files. Mainly include the
below contents:
►Project management
►Create projects
►Input and output project
3.2.1 Project management
Select “Project setting” option card then enter into project management page. The project
management used in all experiment items in the manage system, example check, edit, rename
project or input/output project documents, etc.
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Menu
Project list
Project preview
Picture 3-8 Project management page

Menu created item: click this option and create one test item;
Input project: save the project document in the project file folder;
Output project: save the project document in the project file folder to the appointed address
(picture 3-9). Select the waiting output project and suitable pathway, click “Output” to output this
project, click “All output” can output all project in the project list.
Picture 3-9 Output project

Project list: the list indicated all project documents in the project file folder, classify according to
experiment types. Preview the detail information of project under the interface after clicked the
project name.
Edit project: edit the selected project document;
Rename: rename document in the pop out box after select one project and clicked “Rename”.
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Delete project: delete the selected project.

Project information preview:preview the selected detail information of project.
3.2.2 Create project
The steps of user create one new test item as below:
Click the “Create project” at left side of project set interface and enter into the below interface,
edit the corresponding information.
Picture 3-10 Basic information

1）Basic information
Project basic information
Project name: self define the input of project name
Project type: appoint the experiment project types (qualitative/absolute quantify and standard melt
curve)
Reaction system: reagent reaction volume, the allowed reaction volume is 15~100ul, recommend
volume is 15~50ul(option) if has required input unit and remark information
Test object
Configure each pipe according to the required test target ribotide, include this pipe used colorant
and it’s corresponding passageway, additionally, also can set the curve displayed color of each test
object when testing. The blow table list out this product supported probe/colorant
Test passageway Excite-launched wave length Suitable colorant
Passageway 1 470nm-510nm FAM，SYBR-Green
Passageway 2 530nm-565nm HEX，JOE，VIC，TET
Passageway 3 585nm-620nm ROX，Texas-Red
Passageway 4 630nm-665nm CY5
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The sample can be divided into single pipe and multiply pipe samples according to the quantity of
tested target. The single pipe sample is one sample which has fewer waiting test ribotide orders
(example 1 piece or 2 pieces test target) and can finished in one reaction system (PCR test pipe).
Along with the development of real time PCR technology, more and more experiment need test
the target ribotide above 10 pieces at the same time, but limited by the colorant light spectrum, the
test passageway of real time PCR is limit, under this situation, the user need add the same sample
into multiply reaction system (test pipe) to test in the same time, this sample called multiply pipes
sample; example, 13 type high dangerous sub types to condyloma virus.
Edit the test target of single pipe sample:
►The user select suitable test passageway according to reagent used colorant, tick the select box
under the test passageway;
►Input test target name, the test target name can’t repeat;
►（(Option) If need modify the colorant information then click the probe/colorant information,
select the suitable colorant name in the drop-down menu, the user also can self definition input
colorant or probe name.
Edit multiply pipes sample’s test target:
►Input suitable multiply pipe number in the “Single sample contained test pipe number”
according to reagent specification; the newly added test pipe default name as
“Pipe1”, “Pipe 2”....., click can modify pipe name.
►Select the layout sequence of multiply pipe sample, it has 2 layout sequences;
Transverse rank: multiply test pipes in one sample arrange on the reaction selector (hole plate)
according to the method from left to right;
Vertical rank: multiply test pipes in one sample arrange on the reaction selector (hole plate)
according to the method from up to down;
►Tick the suitable test passageway;
►Input test target name, the test target name can’t repeat; example one test passageway in one
pipe no test target then click the drop-down menu and select “N/A”.
Note: each test passageway at least input one test target
2）Experiment procedure
Click “Experiment procedure” option then can edit the experiment procedure which adopted by
this project.
Shown as the below picture, one PCR experiment procedure divided into several running period,
each running period include several steps, can set the temperature and it’s undergo time of each
steps of each running period, at the same, can appoint the fluorescence test of equipment process
in one period.
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Picture 3-11 Temperature procedure

The below list out one common PCR running period related detail contents.
Field name Description Valid value
Running period The temperature cycle which formed 1-9 pieces
by one or multiply steps
Circulating number Current running period required repeat 1-99 pieces
times
Steps Formed with target temperature and 1-99 pieces
it’s maintain time
Target temperature The need achieved target temperature. 4℃-99℃
Example the denaturation temperature,
extension temperature and anneal
temperature
Maintain time The required maintain time after the 00:01 -99:99
temperature achieved the target
temperature.
Test fluorescence The need collect fluorescence signal Each running period only has one step able to
when running at this step select the test fluorescence
Melt curve running period This is sample slowly rise to another 1 piece
temperature value from one
temperature value, at the same time,
wholly scan the fluorescence signal
Experiment procedure common edit

Insert running period: click the “Insert running period menu” on the menu, add one running period
behind the currently selected running period (red background); also click to insert the running
period drop-down menu, can select to insert the new running period before or behind the currently
selected running period or end of the experiment procedure. Insert of running period also can
through right key single click in the selected running period, then select the method that insert
running period in the pop put menu.
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Picture 3-12
Picture 3-13
Modify the running period name: double click running period name then
can edit and modify the running period name.
Modify circulating number: click the circulating number box which under
the running period, input the circulating number insert steps: click insert step menu, this will insert
one new step after the currently select step. Click insert step drop-down menu also can select to
insert the new step before or behind the selected steps or insert the new step into the final of
current running period. The insert of step also can through right key single click the selected step,
then process through select insert step method in the pop out menu, the detail operations similar to
insert procedure.
Picture 3-13
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Picture 3-14
Modify the step name: double click step name then can edit and modify the step name.
Modify target temperature: the user click the temperature box , input temperature
value, or drag the blue line under the temperature box to modify the temperature.
Modify maintain time: the user click time box , input time value.
Set test fluorescence: can set the collect fluorescence in one step through single click the button
under the time. Click under it’s time box then icon change to be blue , this means
collect fluorescence at the current step.
Note: one procedure period only has one step to collect fluorescence. The step which maintain
time lower than 15s unable to collect fluorescence.
Save picture: right click the experiment procedure and select “Save as picture” then will save the
current experiment procedure as picture.
Default experiment procedure:right click the experiment procedure preview or edit interface in
the software, select “Set as project’s default experiment procedure” then can set this experiment
procedure as default procedure.
3）Experiment parameter
Click “Experiment parameter” experiment card, the user can modify the experiment parameters.
The software provided default parameters suitable to most of reagent box, but users also can edit
or modify the experiment parameters according to actual situation.
If need copy and paste parameters, select copy menu after clicked the parameter cell; then
select waiting paste cell and click paste menu , also can operating through right key order
Recover default parameter: click “Recover default parameter” menu then can recover the
current parameter as default value.
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Picture 3-15
Save and close project
Picture 3-16
Note: must close it first after user create or edit the project documents well, otherwise, can’t quote
this project in the experiment.
3.2.3 Project output and input
The project output and output function of software can save and quote the project through
computer file type, then make the use of project more flexible.
Click “Input project” at project management page,this can input the early saved well project
document in the software system, provide for experiment use.
Click “Output project” at project management page, this can save the saved well experiment
project to the appointed catalog, convenient for save and quote this experiment project.
3.3 Software application

Current version Zybio full automatic medical PCR analyse system software only support
qualitative /absolute quantify and standard melt curve analyse. The user can process
the detail experiment operation according to guidance in this part after carefully read
and understand the front partial contents.
3.3.1Qualitative/Absolute quantify
Qualitative /absolute quantify is the basic and commonly used functions in full
automatic medical PCR analyse system. Qualitative analyse used in test whether
waiting test sample contain the target gene, means process the negative and positive
judgment at sample. Absolute quantify analyse used in test the absolute content
(example the copy quantity of each ml)of waiting test gene in the unknown sample,
commonly used in external diagnose gene content in clinical. The below introduced
the theory base of qualitative /absolute quantify analyse, and explained the means of
refer analyse parameter in software.
About real time quantify PCR experiment
The expansion increase initial period of PCR reaction and target order DNA part present index
method increasing, but along with the increase of reaction circulating numbers, because affected
by the factors like increase of expansion increase outputs, enzyme energy reduce and
pyrophosphate molecule gather, the reaction enter into platform period. The full automatic medical
PCR analyse system real time monitor and record the whole PCR reaction process and draw up to
be expansion increase curve. The below picture displayed the typical real time PCR expansion
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increase curve.
From the above picture we can see that real time fluorescence PCR expansion increase curve
divided into three periods:
Datum line period: the datum line period means the the earliest one part flat area of PCR
expansion increase curve, roughly as 10~15 cycle of expansion increase, it been used in
standardizing fluorescence data. In the initial period of PCR expansion increase, because few
expansion increase outputs, lower generated fluorescence signal and basic submerged in the
fluorescence background, so the datum line period basic reflex the background situation of the
whole system (include instrument and reagent).
Linear period:the fluorescence signal value continue increasing along with processing of PCR
reaction, finally jump out fluorescence background and enter into linear period, present as one
incline upward period area on the expansion increase curve diagram, the inline of linear period
able to basic reflex the expansion increase efficiency. The expansion increase efficiency means the
ratio between output increase quantity after one cycle and template value of this cycle, range 0~1.
At initial linear period, the fluorescence value separate from the background line and achieved one
threshold value, this called fluorescence threshold value, the fluorescence threshold value
commonly are 10 times of datum line fluorescence signal average value add standard difference.
The corresponding cycle number when PCR increase expansion to fluorescence threshold value
called Ct value, C represent Cycle, t represent threshold. The Ct and original template value of
sample at negative reference, can calculate the quantity of original template through function
relation between Ct value and original template.
Platform period: because affected by the unfavourable reaction factors like increase of expansion
increase outputs, enzyme energy reduce and pyrophosphate molecule gather along with the
increase reaction cycle numbers, PCR expansion increase efficiency start descending and the
reaction enter into platform period finally.
About absolute quantify experiment and standard curve
In the real time fluorescence PCR, Ct value of each template and the logarithm of initial copy
number of this template exist linear relation, more initial copy number more smaller Ct value.
Absolute quantify analyse is use a group gradient thinning known concentration standard product
and clinical waiting test sample process test at the same time, get the standard product and Ct
value of waiting test sample after experiment finished; the use the standard concentration LOG
value as axis X, use standard product Ct value as axis Y and draw up the standard curve in the
coordinate diagram. Utilize the standard curve can convenient for calculate it’s waiting initial
concentration after waiting test sample measured Ct value through experiment. This method is
suppose all standard product and waiting test sample has similar expansion increase efficiency, the
concentration of gradient thinning standard product should include the concentration range of
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clinical sample, and in the linear range of real time PCR instrument and test reagent method.
3.3.1.1Qualitative/Absolute quantify experiment process
1）Click the “Newly create project” at left side of “Project setting” interface and create one new
project. For the detail information of create project, please reference 3.2.2 to create project
2）Click “Basic information”, select “Qualitative/Absolute quantify” in the drop-down menu under
the project type; if need then modify project name, reaction system and other information.
3）Input test target information at “Test target” area
4）Click “Experiment procedure” option card and edit experiment procedure

5）Click “Experiment procedure” option card, modify experiment parameter according to reagent
specification. Qualitative/Absolute quantify analyse parameter include basic parameter, quantify
test range and intersecting disturb, the below introduced various experiment parameter function.
Basic parameters
The above picture is basic parameter table interface. From the picture we can see that each test
target all has one set analyse parameters, include:
Analyse type: qualitative or quantify analyse the current target. If select “Quantify” analyse, the
software will calculate the current target concentration value through interior or external standard
curve; when select “Qualitative” analyse, the software judge the negative and positive of waiting
test sample through calculate Ct value.
Datum line:confirm the datum line start point, datum line end point and datum line optimize
method of current target. The datum line will occur a little upward or downward incline when
some reagent in the PCR expansion process because affected by probe or other factors, this datum
line area non linear incline will affect user judge the result. Datum line optimize used in flat
optimize handle these types datum line, make the experiment result recover normal. The selection
of datum line:the datum line need select more flat period in the datum line period, the datum line
start point should avoid several cycles with unstable fluorescence value at experiment start time;
the datum line end point should select one expansion increase curve at the max start concentration
and enter into early several cycles in linear area. Example, suppose the cycle of expansion
increase curve enter into linear area is 15 (one expansion increase curve with max start
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concentration separate off the background line, start “Lift up” circulating value), the datum line
should select number 1~12 cycle, but because it at the start several cycles so reaction system
maybe not stable, the measured fluorescence value sometime not stable, so the datum line can
select number 6~12 cycles.
Datum line optimize: have three options, default value automatically optimize is that software
automatically select suitable datum line start point and end point for each expansion increase
curve and process optimize respectively, this mode suitable to most of reagent box; manual
optimize means the user manually input datum lime start point/end point, not optimize means not
optimize the datum line.
Threshold value: default select automatic threshold value, users also can cancel ticked automatic
threshold value, and input suitable threshold value in the manual threshold value box, the set value
of fluorescence value generally set at 0.01~0.20, recommend tyro select automatic threshold value
or input suitable threshold value according to reagent specification. The setting principle of
threshold value as below:
a）The fluorescence threshold value must set at index expansion increase area (linear area);
b）If set fluorescence threshold value too low then result sensitivity at test error, easy to be
affected by error;
c）If set fluorescence threshold value too high then difference among pipes more bigger affect the
result, and maybe leak test weak positive;
d）The setting value of common fluorescence threshold value at about 10 times of datum line
fluorescence value standard error;
e）The selection of fluorescence threshold value need make the linear of standard curve at best.
The datum line and fluorescence threshold value can repeat adjusted till the best result ( the linear
of standard curve to be best). Need explain that adjustment of parameter is to reduce the
sensitivity of result to measure error and reduce calculate error, but can’t change the original
measure data of experiment, that’s to say, the bad or better of experiment result finally based on
measured the original data, parameter adjustment only be the optimize process.
Digit filtering wave: process smooth filtering wave handle at measured fluorescence data,
eliminate the occur shake disturb error during measurement. Generally, used under the situation
that smaller measured fluorescence signal value.
Quantify test range
Quantify test range used in the highest/lowest test limit at set reagent. The quantify range of
fluorescence quantify PCR test reagent generally from 500IU/ml to 50,000,000IU/ml, if sample
exceed test limit then sample concentration will display “>The highest test limit”, or “<The lowest
test limit”. The user need input the quantify test linear range according to the reagent specification
which provided by manufacturer
Intersecting disturb
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Intersecting disturb table used in calibrate the possibly exist intersecting disturb of multiply color
experiment (multiply passageway experiment) among passageways, The user need input the
suitable intersecting disturb correct value in the table according to the specification which
provided by reagent manufacturer. The intersecting disturb means in the multiply experiment,
because the wave band of excite light which generated by colorant or probe has light overlap
caused the fluorescence signal among each passageway existing light mutually disturb, different
reagent different reagent disturb degree, the user can eliminate the disturb among passageways
through set the intersecting disturb correct value (unit is %) among each passageway, also called
color compensate correction. If the project has multiply test target and analyse parameter value are
same then the user can simply the input through right key order “Copy” and “Paste”.
6）Save and close project.
7）Click “Experiment guide” on the experiment homepage interface to create one experiment. For
more information how to create experiment, please reference 3.1.2 to create experiment.
8）Select “Qualitative/Absolute quantify” of the experiment type in “Basic setting” option card,
input basic information of experiment, and set instrument according to requirements.
9）Click “Hole plate edit” option and select reaction hold on the reaction hole selector, and select
the early created project in the up right project list, then define the reaction hole at down right. The
sample type and property of Qualitative/Absolute quantify experiment check the below table.
Sample type Description Property
Standard product The known DNA concentration sample used in generate Input concentration value
standard curve and quantify unknown sample
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Waiting test sample Waiting test unknown sample Input comment

Repeat test sample The sample need repeat test (if first time test the sample Input comment
which fall in the test gray area, need process re-test
according to actual specification)
Negative contrast Negative quality control Input comment:example 1
Positive contrast Positive quality control Input comment, example +/++

Quality control product Known concentration positive quality Input comment
control
No template contrast The reaction system without template Input comment:example 1
10）Click experiment running option card and click the “Start” at right side of menu, start running
experiment
11）The system will pop out dialog box remind the experiment already finished after experiment
finished, the result file will automatically saved to early appointed file folder. Push out the sliding
cover and pick out the reaction pipe then close the sliding plate and cover the dust proof cover.
3.3.1.2Qualitative/Absolute quantify experiment analyse
The software automatic analyse the experiment result and jump to “Experiment analyse” option
after running finished. Check the experiment data on the experiment analyse interface, up right at
interface indicate the reaction hole information table, if the analyse type of test target is qualitative
analyse,the table display the Ct value and conclusion of test target; if test target is quantify analyse,
the table will display Ct value, concentration, conclusion information. The left side display curve
diagram include expansion increase curve, original curve, experiment procedure and standard
curve.
Expansion increase curve: the expansion increase curve displayed the selected sample’s
expansion increase curve and it’s threshold line after standardizing, if need hide the threshold line
then click right key, cancel ticked “Displayed threshold line in expansion increase curve diagram”.
Original curve: the original curve diagram displayed the original fluorescence curve of selected
sample, this is instrument actual tested fluorescence signal.
More content relate to check experiment information please refer to 3.1.2.5 experiment analyse.
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Standard curve:if the analyse type pf test target is quantify then the software will calculate
it’s concentration value according to standard curve and display the standard curve
chart.
According to different source of standard curve, it can be divided into interior standard curve and
external standard curve. The interior standard curve means that user set standard product (at least
above 2 pieces and different concentration)on the reaction hole plate, the software will
automatically draw the Ct and property value (concentration value) of standard product into
standard curve after experiment finished, and use this standard curve quantify waiting test sample.
Up left of interface displayed the standard curve which all analyse types are quantify test target of
current experiment. Right click this area and select output data then can output the standard curve
information to EXCEL.
If the user selected samples are in the linear range of standard curve then this sample will
displayed on the standard curve. If need save the standard curve, click the “Save” on the external
standard curve menu, tick before the waiting save standard curve project name and input suitable
document name and reagent batch information, finally click save. The standard curve use the
project as unit to save. If not set standard product in experiment or qualified standard product
lower than 2 pieces, the software will remind user calling the external standard products.
Click the external standard curve management at drop-down menu of standard curve, open the
below window, the list display the saved all standard curve )std file folder) which saved in the
software. Click “Input” to save other standard curve in this file folder; select one standard curve in
the list and click output then can save this standard curve into other address.
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3.3.2 Standard melt curve experiment

Melt curve is the double helix structure degrade degree curve which rise DNA along with
temperature. DNA double helix gradually release chain along with rising of temperature during
the PCR expansion increase output heating, it will occur large quantity output release chain when
achieved one temperature, at the same time, the fluorescence rapidly reduced. The temperature at
the total DNA double helix structure half degraded called melt temperature (Tm), different orders
DNA different Tm value. The melt curve process specificity verify the PCR expansion increase
output through utilize the difference of melt appearance of different template and different Tm
value. The melt curve analyse can be used in test the specificity of expansion increase output.
3.3.2.1 Standard melt curve experiment process
1）Click the “Newly create project” at left side of “Project setting” interface and create one new
project. For the detail information of create project, please reference 3.2.2 to create project
2）Click basic information card, select “Standard melt curve” in the drop-down menu under the
project type; if need then modify project name, reaction system and other information.
3）Input test target information at “Test target” area
4）Click “Experiment procedure” option card and edit experiment procedure.

Click insert procedure period drop-down menu and before select current procedure section, add
PCR expansion increase procedure section before default melt procedure section, edit PCR
expansion increase procedure.
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Modify the melt procedure section according to reagent specification. Full automatic medical PCR
analyse system software provided two scanning mode, Continuous scanning and Step scanning,
the below are instruction of two modes:
Scan type Describe Parameter Instruction
Continuous The reaction module of instrument rise Temperature rise The input range of temperature rise
temperature at a certain speed, at the same speed speed of reaction module are 0.01
time, the scan system continue scan the whole ~0.06℃/s
hole plate without interval
Step The scan system scan the hole plate each Scan interval The input range of temperature scan
interval a certain temperature, now the reaction interval of scan system are 0.1 ~1℃
module keep constant temperature at this
temperature point and continue a period time
Constant temperature The maintain time of reaction module at one certain
temperature are 8~99s
5）Click experiment parameter option card, modify the experiment parameter according to reagent
specification. If process PCR expansion increase during experiment then need input basic
parameters; if experiment is multiply color melt curve , some time need input intersecting disturb
correct value.
Click the melt curve parameter option card, input suitable parameter value according reagent
specification. The below introduced the parameter function of standard melt curve:
The min temperature:definite the min temperature of melt curve, all melt peak which lower than
this temperature will be regard as invalid peak;
The max temperature:definite the max temperature of melt curve, all melt peak which higher
than this temperature will be regard as invalid peak;
Noise threshold: means the peak high threshold, used to eliminate the noise and non specificity
varied peaks.
6）Save
and close project
7）Click “Experiment guide” on the experiment homepage interface to create one experiment. For
more information how to create experiment, please reference 3.1.2 to create experiment.
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8）Select “Standard melt curve” of the experiment type in “Basic setting” option card, input basic
information of experiment, and set instrument according to requirements.
9）Click “Hole plate edit” option and select reaction hold on the reaction hole selector, and select
the early created project in the up right project list, then define the reaction hole at down right.
10）Click “experiment running” option card and click the “Start” at right side of menu, start
running experiment
11）The system will pop out dialog box remind the experiment already finished after experiment
finished, the result file will automatically saved to early appointed file folder. Push out the sliding
cover and pick out the reaction pipe then close the sliding plate and cover the dust proof cover.
3.3.2.2 Standard melt curve analyse
The software automatic analyse the experiment result and jump to “Experiment analyse” option
after running finished. Check the experiment data on the experiment analyse interface, up right at
interface indicate the reaction hole information table, it displayed the Tm value and Rm value of
test target; The left side display curve diagram include melt peak value curve, original melt curve,
expansion increase cure, original curve and experiment procedure.
Note:More content relate to check experiment information please refer to 3.1.2.5 experiment
analyse.
Original melt curve: the original melt curve displayed the actually measured temperature Vs
fluorescence value curve of selected sample.
Melt peak value curve: means the derivative melt curve, displayed the max/min temperature
threshold line in the picture. Move the mouse to the temperature threshold line then can leftward
or rightward mdrag.
4 Warning, notices and contraindication

Warning: only used in external diagnose, please read the below notices carefully before use, and
strictly follow.
4.1Operating notices
The staffs who operate this product should been professionally trained at ecsomatics and have the
test operating qualification. The staffs who not been trained can’t operate it. The patient can’t use
it as self inspection.
Can’t use this product in non predicted item test, can’t use the other principle test reagent which
not mentioned by the specification. The test result can’t be used in non predict disease diagnose,
also can’t use in non statement clinical application
4.2 Power supply voltage, connection and grounding

Never insert the power supply plug into the power supply socket out of 220V. Otherwise, it maybe
caused fire or electric shock.
Must make ensure the power supply of equipment broken when installing full automatic medical
PCR analyse system. The power supply must connect at the power supply wire with grounding
protection.
Any operation of broken tester internal and external grounding device or broke the grounding
protection all maybe hurt operator.
Never damage the power supply insulate protection skin, can’t force drag power supply wire or
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hanging heavy object on it. Otherwise, it maybe caused short circuit or broken circuit then caused
electric shock or fire.
If meet suddenly power off during operating, advise process test operation again after recover
supply power.
4.3 Operating process of full automatic medical PCR analyse system

Should cut off the power supply if generate abnormal smell or fog, and plug off the power supply
plug from the power supply socket. Now, should propose the test application to the distributor and
agent company of our company. If continue use under this situation then maybe caused fire,
electric shock or people hurt and dead.
The test sample or reagent, chemical liquid and metal objects shouldn’t fall in full automatic
medical PCR analyse system, otherwise, it maybe caused broke circuit or generate smoke and fire.
The operator can’t touch the internal electric circuit of full automatic medical PCR analyse system,
especially that wet hand touch more possible to electric shock.
The operator don’t touch internal equipment during test process of full automatic medical PCR
analyse system, avoid touched the motion parts.
The rejected material, residual, equipment and fittings should be field handled according to local
hygiene administrate department and environment protection charge department requirements.
Must wear rubber gloves when maintain and check full automatic medical PCR analyse system,
and use the stipulated tools and part. Please use disinfect solution wash hands after task finished.
4.4 Contraindication
Currently not found
5 Failure appearance and handle

Many type reasons happen failure, maybe exist foreign objects affect full automatic medical PCR
analyse system normally working, maybe environment change or operation caused full automatic
medical PCR analyse system can’t normally working, etc, please handle according to the below
advised handle process when occur failure.
Failure type Reason analyse Handle advise
First Full automatic medical Power supply socket not connect power or not Please connect power supply and close the full
PCR analyse system not connect connect power supply or full automatic medical automatic medical PCR analyse system switch, now, the
power PCR analyse system switch not closed power supply indicate lamp will lighting
Equipment failure Shut off the switch, contact the manufacture technical
service staffs
Second The software unable to Windows operating system has error or some New re-install Window operating system
install or unable to open after relate documents already damaged
installed and affect normally use
Third System report error when Instrument internal failure Please the distributor or manufacture technical service
close the heat cover staffs
Fourth The heat cover heating Instrument internal failure Please the distributor or manufacture technical service
temperature exceed range staffs
Fifth Heat cover unable to rise Instrument internal failure Please the distributor or manufacture technical service
temperature staffs
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Sixth Equipment connect Instrument power supply not opened Open the instrument power supply
communication error RS232 series wire or USB adapt RS22 connect Check the RS232 series communication connection
wire not normally connected
Seventh Module temperature rise Air venting port blocked Clean the blocks air venting hole
and reduce speed obviously very
Semi conductor refrigerate sheet damaged Please the distributor or manufacture technical service
slow or temperature display
staffs
incorrect Temperature sensor damaged
Eighth Module exceed Instrument internal failure Please the distributor or manufacture technical service
temperature error or can’t rise and staffs
reduce temperature
Ninth Bad standard curve relate Reagent manufacturer provided standard Contact reagent manufacture
coefficient product concentration value happen deviation
The temperature procedure setting of reagent Contact instrument or reagent manufacture service
not match with instrument staffs
Operation occur deviation Operating according to specification standard
Tenth Signal serial disturb among Because the difference at each passageway Can process the measurement at signal series disturb
passageways colorant, the disturb of different passageways among passageways, and calibrate the bigger signal
lower than 1% unacceptable disturb
Eleventh Expansion increase Sample handle not clean Need remove the varias before handle the sample
curve error Not process sample pretreatment according to Need standard handle sample according to reagent
reagent specification specification
Twelfth Fluorescence test value External strong light source shine The instrument required normal light shine
occur abnormal environment when move indoor
Interior optic-light system damaged Please the distributor or manufacture technical service
staffs
The above failure handle method only been used for user self check and solve the problem, if the
problem still exist after adopted the above method, please contact the technical service department
of our company to handle, never self disassemble the equipment or change on the equipment parts.
Note: please record the relate information or appearance if occur abnormal during test, then close
full automatic medical PCR analyse system power supply and restart equipment. If failure still
existing after finish check above all options, or this abnormal situation occur frequently, please
record error information and contact the local maintain engineers of Zybio Inc. Please use camera shooting the
equipment reminding error information if necessary, convenient for describe the detail situation of error information.
6 Repair, clean and maintenance

6.1 Repair and calibration
6.1.1Repair
The maintain guarantee period of this equipment is one year, can be freely maintain by the
maintain staffs of our company in the maintain guarantee period.
Forbid to renewal fuse when instrument not power off.
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The staffs not authorized by our company can’t disassemble the interior device and elements in
the equipment.
Any operations like adjustment, repair and maintain the equipment interior elements under the
situation with power must be processed by the engineers with experience.
Note:any adjustment, repair and equipment adjustment at other respects must be processed by the
technicians who are authorized by Zybio
professionally trained. If users self process any operation which break this stipulates, all generated
bad result will be undertake by users.
Note: the fittings refer to equipment maintain and repair must use our company sales fittings to
guarantee equipment normally running. For that use the fittings which not sales by our company
and happen un-estimated result, our company will not undertake the responding maintain
responsibilities.
6.1.2Calibration
The calibration of equipment need send to various regions metering institute for calibration
according to user’s requirements or user self calibrate. The calibration according to Polymerize
ferment chain reaction analyse instrument calibrating standard, JJF 1527, the user can self confirm
the re-check time interval according to actual use situation, advise not exceed one year.
6.2Clean and maintenance of full automatic medical PCR analyse system

This equipment easy to maintain, please clean the equipment after equipment power off, the
operation as below:
The exterior surface of equipment can use dustless cloth wet by fresh water and wash, then use the
dry dustless cloth wipe dry it, finally drop few 75% alcohol wipe clean it. Please use dustless cloth
clean the corner of equipment.
The reaction hole will affect PCR expansion increase and fluorescence test after stick dust or
varias so need fix time clean, generally one time each three months, can use dust blow ball lightly
blow wipe it.
The instrument must close sliding plate and cover dust proof cover when not use, to prevent the
dust enter into reaction holes.
If has reagent enter into reaction holes, should use dustless cloth add 75% alcohol wipe clean it.
Please don’t open equipment to clean;
The clean maintain period: advise one time clean and maintain equipment each two weeks, the lab
can self stipulate the clean maintain period.
Warning: the normally test process maybe pollute the equipment, please wear the gloves when
cleaning equipment.
Forbid to clean instrument when equipment not power off.
6.3 Renewal fuse

The instrument installed one F5A fuse used in instrument over current protection. The user can
renewal the fuse according to the below instruction after found the fuse damaged. Close the
47
equipment and plug off the power supply wire from the grid power supply and equipment power
supply switch base.
Use straight screw driver lightly prize out from the fuse box, pick out the damaged fuse and
renewal new fuse, then press the fuse box cover into equipment power supply switch base. Finally
insert the power supply wire and paralleling connect to grid power supply, start equipment.
Warning: must shut off the power supply and plug off the power supply wire before renewal
fuse.
6.4 Other notices

Must wear the safety protection glasses and gloves when handle poisonous, corrode or infectious
materials.
Though we touched high purified ribotide but still need be carefully attention at the potential harm
at all bio materials. Must follow the local safety standards when handle or discard these samples.
Should use suitable disinfectant disinfect if unexpected happen splash or leakage, to prevent lab
staffs and equipment pollution.
Strictly operating according to the safety reminding on the instrument.
The equipment power supply adapter should keep a certain distance with wall, convenient for
power supply adapter connect and break operations.
Can’t push out the heat cover when instrument running.
Strictly touch metal module when instrument running and running finished in a certain period,
avoid scald.
7 Medical treatment apparatus label used figure, symbol and

abbreviation instruction
The used figure, symbol and abbreviation instruction on the label and package mark as the below
table:
Symbol Instruction Symbol Instruction
Upward Fragile materials
Anti proof External diagnose medical treatment equipment
Attention high temperature This symbol used to represent: must prevent

carefully when touch the materials with potential
infect danger
The product has place nee be attention,
the detail contents check the specification
document along with goods
8 Electromagnetic compatible(EMC) instruction

The users should make ensure that only can be used in the suitable environment to guarantee
correctly use equipment, so propose the below several notices aim to system electromagnetic
48
radiation, maintain and electromagnetic anti disturb ratio:

a) The equipment are in accordance with the launch and anti disturb ratio requirements which
stipulate in GB/T 18268.1 and GB/T 18268.26.
b) This equipment design and test according to grade A equipment in GB4824. In the family
environment, this equipment maybe caused radio disturb, need adopt protection actions. (If it is
grade B then needn’t)
c)Advise evaluate the electromagnetic environment before use the equipment.
d)Forbid to use this equipment beside the strong radiation source (example non shield radio
frequency source), otherwise, it maybe disturb the equipment normally working.
e) The environment of install and put in use full automatic medical PCR analyse system
(Model:Lepgen-96) need have special prevention and actions to EMC, need be in accordance with
the EMC information provided in the below table.
f) Portable and moveable ratio frequency communication equipment maybe affect the full
automatic medical PCR analyse system (model:Lepgen-96).
g) Full automatic medical PCR analyse system (model:Lepgen-96) aim at all cable and the max
length cable, sensors and other fittings in the system all need be in accordance with
electromagnetic compatible requirements.
Note: for the use of fittings, except the sensor and able which sales by full automatic medical PCR
analyse system (Model:Lepgen-96) manufacturer can be as replace parts of interior assemblies,
the sensors and cables of other manufacturer which not appointed by us maybe caused full
automatic medical PCR analyse system (Model:Lepgen-96) add electromagnetic discharge or
reduce anti disturb capacity when used in this product.
8.1 Electromagnetic radiation

Table A-1 detail introduce the electromagnetic radiation accordance and guide advise of full
automatic medical PCR analyse system (Model:Lepgen-96).
Table A-1 Manufacturer statement and guide advise-electromagnetic discharge
Discharge test Test Electromagnetic environment-guide
requirements
Radio radiation One group Full automatic medical PCR analyse system
CISPR 11 (Model:Lepgen-96) only use the radio frequency energy at it’s
interior function. So, it’s very low radio frequency radiation,
never disturb the nearby electric equipment.
Radio radiation Category A Full automatic medical PCR analyse system
CISPR 11 (Model:Lepgen-96) suitable to all place, include all the places
Harmonic wave discharge Unsuitable that domestic directly connect to public low voltage supply
GB/T 18268.1 power network, can be used in the family indoor.
Voltage wave/flashing launch GB/T Unsuitable
18268.1
8.2 Electromagnetic disturb

Table A-2 used in introduce the electromagnetic disturb ratio and guide advise of full automatic
medical PCR analyse system (Model:Lepgen-96).
49
Table A-2 Manufacturer statement and guide advise-electromagnetic disturb ratio

Anti disturb test GB/T 18268.26 Experiment Electromagnetic environment-guide
Test level requirements
Static electricity Contact electric discharge±2 Contact electric The equipment should be placed on
discharge (ESD) kV discharge ±2 kV wood, concrete or ceramic. If
GB/T18268.26 ±4 kV ±4 kV equipment placed on the combine
Air electric discharge±2 kV Air electric discharge materials then the relative humidity
±4 kV ±2 kV should be at least 30%
±8 kV ±4 kV
±8 kV
49
Electric quickly AC/DC power supply wire trial AC/DC power supply trial The power supply quality
transient pulse group electric level±1 kV L/N/PE electric level±1 kV L/N/PE should be typical commerce
anti disturb ratio Signal cable trial electric level ±0.5 Signal cable trial electric level or hospital environment
GB/T18268.26 kV ±0.5 kV
Surge AC/DC power supply wire AC/DC power supply wire

GB/T18268.26 grounding electric level grounding electric level
±0.5 kV ±0.5 kV
±1 kV ±1 kV
±2 kV ±2 kV
AC/DC power supply wire to wire AC/DC power supply wire to
electric level wire electric level
±0.5 kV ±0.5 kV
±1 kV ±1 kV
Voltage sags, short Voltage sags Voltage sags The power supply quality
time interrupt and 0 % UT， 1 period 0 % UT， 1 period should be typical commerce
voltage change anti 0 % UT，0.5 period 40%UT， 5 periods or hospital environment. If
disturb ratio on the 40%UT， 5 periods 70 % UT， 25 periods equipment users need
power supply input 40% UT， 6 periods Voltage interrupted continue running during
wire, GB/T18268.26 70 % UT， 25 periods ≤5 % UT，250 periods power supply interrupted,
70 % UT， 330 periods advise use non interrupt AC
Voltage interrupted power supply.
≤5 %UT， 250 periods
≤5 % UT， 300 periods
Industry frequency Trial frequency Trial frequency Industry frequency magnetic

magnetic field anti 50 Hz 50 Hz field should be the
disturb (50/60 Hz) 60 Hz 60 Hz characteristic level of typical
GB/T18268.26 Trial level Trial level position (example commerce
3A/m 3A/m or hospital)
50
8.3 Calculating the interval distance between communication equipment and

system
Table A-3 is provide the guide advise for correctly use full automatic medical PCR analyse system
(Model:Lepgen-96) under the situation with communication equipment, provide the calculate
formula of the distance among them.
Table A-3 Manufacturer statement-Electromagnetic anti disturb ratio of communication equipment and system
Disturb test IEC 60601 Accordance level Electromagnetic environment-guide advise
Test level
Input ratio Except 3Vrms [V1] V The use distance from them to full automatic
frequency 150kHz ~80 MHz ISM medical PCR analyse system (Model:Lepgen-96)
GB/T 17626.6 frequency band can’t lower than recommended interval distance
Within 10Vrms [V2] V when using any portable and moveable radio
150kHz ~80 MHz frequency communication equipment. This interval
ISM frequency band distance calculating formula unsuitable to
transmitter
Recommend interval distance is d=[3.5V1]√�
d=[12V2]√�
Radio frequency Within 10V/m [E1] V/m Recommend interval distance:

radiation 80MHZ~ 2.5 GHz d=[12E1]√�80 MHz to 800 MHz
GB/T 17626.3 d= [23E1]√�800 MHz to 2,5 GHz
P is the max output rated power of transmitter which
provided by transmitter manufacturer, use Watt (W)
as unit. d is the recommended interval distance, use
metre (m) as unit.
The magnetic field strength from the fixed radio
frequency transmitter, formed with one
electromagnetic station service, should be lower
than each frequency range and accordance the
stipulated level. The disturb maybe happened nearby
the equipment which marked the below symbol:
Note 1 Suitable in the more higher frequency range when at 80 MHz and 800 MHz.
Note 2 These rules maybe unsuitable to all situation. The electromagnetic transmit easily affected by the structure, absorb
and reflect by objects and human.
8.4 Interval distance between communication equipment and system

Full automatic medical PCR analyse system (Model:Lepgen-96) able to suitable in the
electromagnetic environment where control the radiation disturb. According to the max output
power of communication equipment, the propose which provided in table A-4 assist to help
51
equipment user keep the min distance between portable and moveable radio frequency equipment
(launcher) and full automatic medical PCR analyse system (Model:Lepgen-96) to anti
electromagnetic disturb.
Table A-4 the recommend interval distance between portable and moveable radio frequency equipment (launcher) and
full automatic medical PCR analyse system (Model:Lepgen-96)
The rated max Transmitter frequency interval distance (m)
output power of d=[3.5V1]√� d=[12V2]√� in 80 MHz~800 800 MHz ~2.5 GHz
transmitter (W) except 150kHz~80MHz ISM MHz d= [23E1]√
150kHz~80MHz frequency band d=[12E1]√�
ISM frequency band
0.01 0.035 0.12 0.12 0.23
0.1 0.11 0.38 0.38 0.73
1 0.35 1.2 1.2 2.3
10 1.1 3.8 3.8 7.3
100 3.5 12 12 23
The above table not list out the data of max output power transmitter, the recommend interval distance d meter(m) can
use equation estimate the frequency suitable to transmitter, among, P is the max output rated power of transmitter which
provided by transmitter manufacturer, use Watt (W) as unit, d is the recommended interval distance, use metre (m) as
unit.
Note 1 Suitable to interval distance at higher frequency range when at 80 MHz and 800 MHz.
Note 2 The frequency band of ISM (industry, science and medical treatment)from 150 MHz to 80 MHz are 6.765 MHz
to 6.795 MHz; 13.553MHz to 13.567MHz; 26.957MHz to 27.283MHz;and 40.660MHz to 40.700MHz.
Note 3 When calculating the ISM frequency band from 150 kHz to 80 MHz and the transmitter recommend interval
distance from 80 MHz to 2.5 GHz frequency band, can use 10/3 additional coefficient, to reduce the possibility that
moveable portable communication equipment (unexpected bring into patient area) maybe caused disturb.
Note 4 These rules maybe unsuitable to all situation. The electromagnetic transmit easily affected by the structure,
absorb and reflect by objects and human.
Note 5 V1= 10 Vrms, V2= 10 Vrms, E1= 10 V/m.
9 Electric safety
Electric safety requirement are in accordance with safety requirements of measure, control and lab
used electric equipment, GB 4793.1-2007, part1: general requirements, safety requirements of
measure, control and lab used electric equipment, GB 4793.6-2008, part 6: lab used analyse and
the special requirements of automatic and semi automatic equipment at other propose and safety
requirements of measure, control and lab used electric equipment, YY0648-2008, part 2-101:
suitable clauses requirements in Exterior diagnose (IVD) medical treatment equipment special
requirements.
10 Working life
This working life confirmed the working life at 6 years after process speed up working life
experiment refer to Product speed up experiment method, GB/T 34986-2017,
52
AcceleratedLifeTestingReference of ReliaSoft company and commonly used speed up model in

source medical treatment apparatus. During use, the user should repair and maintain according to
product specification. The products which been confirmed that still be able to maintain basic
safety and availability after repaired and maintained can be normally use.
11 Manufacture information
[Medical treatment apparatus register certificate number/product technical requirements number]
[Product name]full automatic medical PCR analyse system
[Model and specification]Lepgen-96
[Register/manufacturer name]Zybio Inc
[Address] Floor 1 to Floor 4, Building 30, No. 6 Taikang Road,Block Cof Jianqiao Industrial Park,
Dadukou District, Chongqing, China 400082
[Manufacture address] : Floor 1 to Floor 4, Building 30, No.6 of Taikang Road, Block C of Jianqiao
Industrial Park, Dadukou District, Chongqing, China 400082.
Contact phone: +86(0)23 6865 5509 Fax: +86(0)23 6869 9779
Website: www.zybio.com
[Manufacture certificate number] Beijing food&drug supervise apparatus manufacture certificate
NO.20100056
[Produce date] check the product data plate or exterior package
[Draw up or modify data of specification]
53
Appendix 1: Patient report format template

1Patient report manage device
Click the “Print” drop-down menu at the “Experiment design” option, select “Patient report
template management” menu and enter into patient report template management. Shown as the
below picture:
The software provided multiply patient report’s pattern template, click the left side “Patient report”
pattern list then can preview patient report pattern. Click “Input” then save other patient report
pattern template to default file folder (Report file folder); click “Output” to save the pattern
template to other pathway. If need delete the pattern template then select the waiting delete pattern
in the list then click “Delete”.
2 Newly create patient report template

Click “Print” drop-down menu at the “Experiment design” option, select “Newly create patient
report template”, input the document name in the pop out box, it will open one blank Microsoft
word file after confirmed, the users can create patient report pattern template in this file.
54
\
Zybio full automatic medical PCR analyse system software fix information through search/replace
key word, the below table displayed all information and key words in the patient report list.
Name Key words
Name $name#
Sample number $label#
Sex $sex#
Age $age#
Hospital name $hospital#
Medical record number $caseid#
Sampling date $collectdate#
Test date $testdate#
Report date $reportdate#
Send test office $office#
Clinical diagnose $diagnosis#
Sample types $sampletype#
Send test doctor $doctor#
Operator $operator#
Auditor $assessor#
Expansion increase curve $curve#
Project name $project#
Remark $remark #
The below introduce how to create patient report list pattern template through one typical
fluorescence quantify PCR test report list sampling introduce, shown as the below picture. This
report list include hospital information, patient information, patient diagnose conclusion and PCR
expansion increase curve of patients.
55
Input the information and key words according to the below picture in the Word file:
Insert any one picture at the suitable position, right click to select “Size....” menu on the picture,
open the below dialog box, click can select word option card, input “$curve#” in optional word
box.
If user used Microsoft office word 2010 then select the right key menu “Set picture format” in the
picture and select “Optional word” option card and input “$curve#” in introduce.
It shown as below after finish pattern template edited:
56
3 Patient report template setting

Click “Print” drop-down menu at the “Experiment design” option, select “Patient report setting”
menu.
Input hospital information in “Hospital name”. Select “Patient report template of setting project”
option, and match suitable print report list template for project.
57
Select “Print setting” option, can set pattern of curve.
58
Appendix 2: Software reminding error information summary
Reminding error information Error reason

Click “Experiment guide” then occur the below 1. The equipment not power on running
error: 2. Series port not connected or series port wire damaged
Occur error during experiment running 1. Equipment power off

2. Series port wire plug off or series port wire damaged
Occur error when click “Start” to run experiment The sliding cover of instrument not tightly pushed, need
tightly pushed
59

【Zybio】IFU-Lepgen 96

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Full automatic medical PCR analyse system (Model:Lepgen 96) Operating Specification

Full automatic medical PCR analyse system

3.3.2 Standard melt curve experiment.............................................................................................42

Attention the notices under this mark.

1 Full automatic medical PCR analyse system introduce

The fluorescence strength test

1.2 Application range

1.4Main structure form

1.5Product package list

1.6 Panel profile

The running indicate lamp

The power supply indicate lamp

Picture 1-1 Front panel

Picture 1-2 Sample pool

Picture 1-3 Rear panel

1.7 Full automatic medical PCR analyse system working, transporting

and storage condition

Power supply AC220V～、50Hz

Input power 800VA；

Size 490mm x355mm x284mm；

Working condition 1) Temperature: 10～30℃

1.8 Fittings list

2 Installation of full automatic medical PCR analyse system

2.2 System installation

4）Waiting uninstall finished then OK.

3 Zybio full automatic medical PCR analyse system operating introduce

Picture 3-1 Main interface

Picture 3-2 Experiment basic setting

Picture 3-3 Plate hole edit

Picture 3-4 Sample information

Picture 3-5 Experiment running

C. Print the patient report

3.1.4 Open experiment

3.1.5 Running quick experiment

3.2 Project setting

Picture 3-8 Project management page

Picture 3-9 Output project

Delete project: delete the selected project.

Picture 3-10 Basic information

Picture 3-11 Temperature procedure

Experiment procedure common edit

3.3 Software application

3）Input test target information at “Test target” area

4）Click “Experiment procedure” option card and edit experiment procedure

6）Save and close project.

Waiting test sample Waiting test unknown sample Input comment

Positive contrast Positive quality control Input comment, example +/++

3.3.2 Standard melt curve experiment

3）Input test target information at “Test target” area

4）Click “Experiment procedure” option card and edit experiment procedure.

4 Warning, notices and contraindication

4.2 Power supply voltage, connection and grounding

4.3 Operating process of full automatic medical PCR analyse system

5 Failure appearance and handle

6 Repair, clean and maintenance

6.2Clean and maintenance of full automatic medical PCR analyse system

6.3 Renewal fuse

6.4 Other notices

7 Medical treatment apparatus label used figure, symbol and

Anti proof External diagnose medical treatment equipment

Attention high temperature This symbol used to represent: must prevent

8 Electromagnetic compatible(EMC) instruction

radiation, maintain and electromagnetic anti disturb ratio:

8.1 Electromagnetic radiation