Handheld Coagulation Analyzer

Model：LA-100

USER MANUAL

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 Preface

Respected customers:

This manual is suitable for handheld coagulation analyzer and used clinically with blood coagulation
test strip for blood coagulation test of human samples.

The sample flows to the reaction area due to the capillary force when the blood sample is dripped into

the test strip. Each reaction interval contains a pair of metal electrodes. The handheld coagulation

analyzer generates a constant voltage output to the metal electrode. In the reaction area, the blood

sample combine with the immobilized reagent to induce a series of biochemical reactions to start to

coagulate. The device monitors the process of blood coagulation and the change of current signal, then

generates the coagulation curve with the change of current and time. In the coagulation curve, the

current signal rises and reaches its peak at the beginning due to the connected two electrodes with the

flow of the sample. With the activation of coagulation factors during the process of coagulation and the

conversion of fibrinogen into fibrin, the curve changes accordingly and produces corresponding

characteristics (height, area, etc.). The supporting device analyzed the coagulation characteristics of this

curve and calculate the time of the coagulation item of the sample.

All the consequences caused by the failure to use the product in accordance with the user manual shall be

undertaken by the user!

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 Catalog

1. Product Name and Model…………………………………………......................................………………………4

2. Registrants, Manufacturer and After-sales Service…………….....................................……………....4

3. Performance Characteristics…………………………………………....................................…….…………......4

4. Main Structure Composition………………………………………....................................….……………………5

5. Application Scope……………………………………………………………..........................................….…………5

6. Contraindication………………...…………………………………………….........................................…………....5

7. Attention Matters, Warnings and Precautions………..……………………..............................…………...5

8. Operation………..................................................................................………………………….……….…..7

9. Cleaning, Calibration and Maintenance…………………….......……………...............................…....…..13

10. Storage and Transportation……………………………………………………...............................................14

11. Production Date and Expiry Time……………………………………….................................……..….........15

12. Label………………………..……………………………………………………….............................................……...15

13. Packing List…………………………………………………...……………..........................................…………..…..16

14. Electromagnetic Compatibility…………………………....................................……………….…………….…17

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1. Product Name and Model
1.1 Product Name: Handheld Coagulation Analyzer
1.2 Model：LA-100
1.3 Model Division Explanation
L A-100

Indicate product model;

Indicate product type: handheld device;
Indicate company code
1.4 Software
Software Name: Handheld Coagulation Analyzer
Model：LA-100
Release Version: V1.2

2. After-sales Service
Address: No.2 Qiande Road, Jiangning District, Nanjing
Origin: Nanjing, China
Manufacture Address: No.2 Qiande Road, Jiangning District, Nanjing
Tel:0086 15817012363
Manual Revision Date: April 30, 2021

3. Performance Characteristics
3.1 Performance indicators
Accuracy: ≤5%
Repeatability: CV≤5%
Stability: The stability of the analyzer should be within ±5%.
Linearity: Within the test range (1.5-6.5 g/L) of fibrinogenstrip(FIB), the linear correlation
coefficient r≧0.98.
3.2 Other parameters are shown in the below table.

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 Sheet 1-Main Parameters

Item Parameters
Detection speed of a single
1-12min
specimen
Test item Support PT, APTT, TT, FIB, ACT single or multiple
Average time of trouble-free
≥1000h
work
Communication RS232、4G、WIFI、Bluetooth
Storage ≥3000
Incubation temperature 37.0±1℃
Working temperature 10-30℃
Print Function External Bluetooth thermal printer (optional)
Injection Mode Manual Sampling
Screen 5’ color touch LCD; Resolution: 720*1280
Device Size（L×W×H） 194×93×37 mm
Packaging Size（L×W×H） 242×137×111 mm
Weight N.W.: 0.23kg
Power Supply 18650 lithium battery：DC 3.6V, 3350mAh

(a) Adapter input voltage: 100-240VAC 50/60Hz 0.2A MAX

Power Adapter
(b) Output Voltage：DC 5.0V 5.0A

4. Main Structure Composition

This product is composed of electrochemical detection module, display module, scanning module, power
module and external communication module.

5. Application Scope
The handheld coagulation analyzer is used in conjunction with the electrochemical kit and can be
used for quantitative measurement of prothrombin time (PT) and activated partial thromboplastin time
(APTT), fibrinogen (FIB), thrombin time (TT), activated clotting time (ACT) in human whole blood or
peripheral blood. The test results are used for assisting clinical diagnosis.

6. Contraindication
There isn’t known contraindication yet.

7. Attention Matters, Warnings and Precautions

7.1 Tips and Warnings
The user manual contains two categories of hazards, which are represented by hazard, warning:

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 The reagents and specimens used in the device may be corrosive or
Biohazard contagious. Please pay attention to the self-protection when operating
the instrument and waste centralized for processing.

Before operating the instrument, please check the instructions first

Warning
and strictly operate it by steps.

7.2 Attention Matters of Starting and Working

Connect the installed device to the power line and turn on the power switch. The device enters
self-checking. If normal, a short sound will be sounded and the interface for scanning code will be
displayed. If abnormal, the error code appears in the prompt box of the instrument. Please refer to the
fault list.

7.3 Operation Precautions

a) This instrument is a medical device for in vitro diagnosis. It does not support household use and is only
for professional use.
b) Ensure the table clean and tidy. The samples to be measured and containers are properly put aside and
the samples are numbered.
c) Ensure the device connected to the correct power supply.
d) Ensure the used test kits not placed in the sampling parts.
e) Confirm the good quality of the test kits and samples, no deterioration and the enough quantity.
f) Please pay attention to safety protection, safety signs and instructions before and during operation.
g) The operator needs to wear gloves in the operation.
h) This instrument is only matched with Coagulation Panel Prothrombin time/ Activated partial
thromboplastin time/ Fibrinogen/ Thrombin time/ Activated clotting time Combo (Electrochemical
method) produced by Lansion
i) The instrument is installed in an environment that is dust-proof and has an indoor temperature of
5-37℃, supposed to be equipped with air conditioner.
j) All components and parts except printing paper and consumables must be provided by our company.
Otherwise, our company won’t be responsible.
k) Power Supply: lithium battery DC 3.6V, 3350mAh.
l) If there is something wrong with the instrument, please contact us in time. Without permission, anyone
who are not authorized as professional maintenance staff by our company can't check and disassemble
any parts of the instrument. Otherwise, our company won’t be responsible for any problem.
m) In the case of standardized operation and reasonable maintenance, the service life of the instrument is
3 years (no more than 8 hours per day).

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7.4 Warning and Prompting
a) The handheld coagulation analyzer is only suitable for the in-vitro analysis of human blood samples, no
other specific use.
b) Only the test strip mentioned in this manual can be adopted, otherwise the obtained results might be
unreliable.
c) The device should be used in accordance with the prescribed method, otherwise the protection
provided by the equipment may be damaged.
d) Please read this manual carefully before operating the device, and keep it in a safe place for future use.
e) If the device gives off an unusual smell or smoke, cut off the power and contact with after-sales
engineers immediately, otherwise it would result in a fire, electric shock or personal injury.
f) If any liquid enters in the interior of the instrument, cut off the power and contact with service
engineers immediately, otherwise it would result in a fire, electric shock or personal injury.
g) Please comply with all national health and safety standards, including, but not limited to, gloves and
appropriate laboratory equipment when operating and maintaining the instrument.
h) The operator or charge person of the instrument shall be trained upon attention matters and operation
guidance of the instrument by the after-sale engineer, and the device only can be operated after the
training.
I) If the instrument is out of service due to maintenance and disposal, the user should mark the
instrument in a timely manner to prevent misuse; for the instrument that has been used, it is
recommended to use 75% medical alcohol cotton on the outer surface of the instrument and the
inspection port before stopping use. After disinfection, subsequent processing or transportation can be
carried out. As the samples involved may have potential biosafety risks, the operator or person
responsible for the instrument shall not disassemble or assemble the instrument privately to avoid
infection. Be sure to wear gloves, work clothes, and protective glasses when necessary.

7.5 Waste disposal

The processing of instrument packs, used test strip and waste scrap apparatus refer to local laws and
regulations; If the equipment is out of service due to maintenance or treatment, the user shall take
disinfection and other preventive measures during transportation, treatment or destruction of the
analyzer to minimize biological hazards. It is suggested that the user disposal or destruction it according
to the Type B electronic instrument regulations. The used test cards should be destroyed according to the
local biological hazardous material handling regulations.

8. Installation and Operation

8.1 Installation

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Carefully unpack the analyzer and check the appearance. Please make a statement immediately if
there is any transport damage. Check the analyzer and confirm the packing list to ensure the complete
configuration. Please contact with our after-sales department or the regional agent if you find that the
configuration is not complete.
Place the mainframe of the handheld coagulation analyzer on the platform. Connect the power adapter
and open the machine normally.
After the installation is completed, test with QC card and compare the result with the target value. It turns
out the successful installation of the analyzer if the result is correct.

a) Avoid direct sunlight or near heat source and wind regime.

b) Not used in a strong magnetic and wet field.
c) The instrument should avoid excessive dust erosion.
d) The staff for installation and operation of the instrument must be
trained professionally.

Attention e) Correctly use the power adapter configured in this instrument,

connect the power line and attach the power plug.
f) If encountering the resistance as installing the components, please find
out the cause, and avoid violence to prevent damage to the instrument.
g) Please do not use other power adapters instead of the originally
equipped power adapter, so as to ensure the suitable power supply
socket.

8.2 Operation
8.2.1 Software Module and Function
This product can be divided into 3 modules according to its functions and applications (see P1):

Test This function can be used for sample test, patient information input and so on.

This function can search historical data and print selected records. Users can
Query
search through sample No. and time.

This function is used for the basic setting of the instrument and QC
System Setting
management setting.

On/Off This function can realize the one-switch turning on or off the instrument.

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 P1- Scan Interface
8.2.2 On/Off
This function is realized by the main control key on the panel. Short pressing to turn on and long pressing
for 2 seconds to turn off.
8.2.3 Test
a) Enter the Scan Code Interface after the initialization is completed (see P1).
b) Remove the reagent strip and place it on the workbench. Click ‘Start Scanning’ button. Align the scan
module on the lower part of the device with the QR code on the test strip to read the batch number of
the test strip. If the batch number is valid, a prompt “Insert the strip” pops up, otherwise an alarm
prompt pops up and return to Scan Interface;
c) Insert the test strip to enter the information entry interface
d) The information (name, gender, age) of the inspected person can be manually entered on the
Information Input Interface. The information is automatically saved in the sample list after information
input is completed.
e) The loading device is used to adding the sample when the reminder “Please add the sample” is
displayed on the screen. The device automatically starts to test when the sample enters the sample ports
of the test strip.
f) The test result pops up after the test is completed. The user can upload the test report and print the
test result on the interface of testing result.
8.2.4 Query
a) Click “Query” button on the Scan Code Interface after the initialization is completed, enter into the
Record Query Interface (See P2).
b) The user can manually input the required query conditions and click “Query” on the query interface.
The sample view interface pops up after selecting the records that need to be printed or uploaded, then
corresponding button can be clicked to print or upload.

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 P2 Record Query
8.2.5System Settings
The System Setting interface is shown in P3. It mainly includes the following functions: functional settings
(including Printing, WIFI, Bluetooth, Language/time setting), QC Management, Engineering Debugging.
1) Click on the print setting switch to select whether to print the test result automatically.
2) Click on the “Setting” button to enter the WIFI setting interface. The internal users of the interface
can obtain the available WIFI nearby and connect to the user-specified WIFI by entering the password.
3) Click on the “Bluetooth” button to enter the Bluetooth setting interface. The internal user can
obtain the available Bluetooth devices nearby and connect to the user-specified Bluetooth by entering
the PIN code.
4 ） Click the "4G" button to enter the 4G setting interface, where internal users can set the server
address and connect;
5) Click on the “Language Time” button to enter the language and time setting interface. The user can
manually select the language, time and date, and click on return to save the settings.

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 P3 System Setting

6) Device QC
a) Click on the ‘Device QC’ button in the system setting interface and enter the QC interface (see
P4);
b) The user can manually input the query conditions, click “Query” button to check the
corresponding QC record.
c) Click on “Test” button to proceed QC after inserting the QC strip. QC results are added to the QC
list, Whether or not the details of the quality control process work normally will be displayed. If
not, please contact the manufacturer.

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 P4 Device QC

8.2.6External Bluetooth thermal printer(Optional)

The handheld device is gently pushed in along the base card slot until the connector male is fully inserted.
8.3 Network Security
8.3.1 Hardware configuration
Processor: STM32f407, MSM8909
External memory: FLASH
Internal memory: DDR3
Code scanner: MJ-2000
Power supply: 5V power supply
Screen: 5-inch capacitive screen
8.3.2 Software environment
Editing environment: Android
Writing language: Java
Debugging tool: OTG
Download tool: OTG
8.3.3 Network security
a) Communication: Bluetooth, WiFi, 4G, RS232 serial port.
Bluetooth transmission adopts 4.2 and above protocols, which is only used to connect customized
external printers, and the effective transmission distance is no more than 1m;
WiFi and 4G are used for remote upgrade programs;

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RS232 serial port transmission is a serial port protocol, which is used to upload data with the
hospital LIS system.
b)User access control
User identity authentication method: need to log in with a user name and password.
A) Ordinary users: sample testing, record query, quality control management, data upload functions;
B) Engineer: In addition to ordinary user functions, you can enter the engineer to debug.
8.3.4Software environment and security software updates
The product does not support partial updates of system software or clinical application software. Before
the updated software arrives on site, all changes will undergo rigorous testing to ensure that the system
meets safety, reliability, and performance standards. The software update is performed by an authorized
Lanyu company's on-site maintenance engineer. This is the only way to update the product software.
The company regularly evaluates software security, monitors security vulnerabilities, and conducts impact
assessments. If unacceptable risks that pose a threat to product safety and effectiveness are discovered,
the company will implement software updates.

9. Cleaning, Calibration and Maintenance

9.1Cleaning
1) Wipe the exterior of the instrument with clean and damp cloth after each use. Mild detergent or
disinfectant (eg 5% bleach or 70% medical alcohol) can be used.
2) Use medical alcohol sponge (75%) to wipe area around the detection port of the device.

The device must be stopped before cleaning, please refer to the operation
Attention
procedures, methods and precautions for shutdown.

9.2 Calibration
The device shall be calibrated on a regular basis of using a QC card (recommended once for one month) to
ensure the accuracy of the test.
9.3 Maintenance
9.3.1 Monitor Maintenance
Due to temperature, power supply voltage changes or other factors, the monitor may not display, or the
handwriting shown is too light or too dark. The person concerned should be requested to maintain the
service.
9.3.2 Printer maintenance
Replace the printer paper according to the software prompts.
9.4 Maintenance and repair for longtime shutdown
Firstly remove the reagent strip and clean the device refer to the daily cleaning procedures , and then
stored in a dry and shady place with a dust cover for the device.
Note: The instrument has a built-in lithium battery. When it is not used for a long time, please charge
the battery to 50% and store it at least once every six months.
9.5 Alarm analysis and processing methods
If you receive an error code, please re-test. If you receive an error code again, please contact
regional distributor and use the laboratory method to test. Under no circumstance should the
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 error code be used as patient test result.

Troubles Resolvent

Restart. if the problem persists, please contact

LCD is not on or does not work.
after-sales service

The serial port communication is abnormal,

Can't enter the main interface by clicking
please shut down and restart. if the problem
login
persists, please contact after-sales service

Scanning code shows illegal calibration QR

Scan the code again after changing the QR code
code
Please scan the code within 5 seconds and re-scan
Scanner timeout the code. if the problem persists, please contact
after-sales service

Battery level is less than 10% Please test after charging

Check whether the network connection is normal.

Remote update read exception if the problem persists, please contact after-sales
service

Sample addition timeout Please add samples within 10 minutes

The test result is disturbed Interference during detection

The detection process is abnormal, please test

Abnormal test results
again

If the above phenomenons occur, the customer can not deal with the trouble themselves, please contact
Lansionbio’s technical support team timely. The problem, involve instrument parts, should be determined
by Lansionbio’s engineers to provide replacement parts.

10. Storage and Transport

10.1 Working environment:

a) Temperature: 10℃~30℃;
b) Relative humidity: <90%，no condensate;
c) Air pressure: 86.0kPa～106.0kPa;

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d) Altitude environment: The altitude environment where the product is expected to be used is
≤2000 m.
e) Battery conditions：Charging Temperature: 0℃—+45℃, Working Temperature: -20℃-50℃，Optimum
Working Temperature: 20℃-40℃, above 100 ° C will be dangerous, generally 140 ° C will burn or explode.
f) Other instructions：Workplace should try to avoid dust;
Keep away from strong electromagnetic interference sources;
Avoid direct exposure to strong light and keep it well ventilated.
10.2 Storage and transportation conditions
a)Temperature：-20℃~55℃；
b)Relative humidity：≤90%，No condensate；
c)Air pressure：50.0kPa~106.0kPa；
d)Other instructions：
Non-corrosive gas and well-ventilated place；
The packaged analyzer shall be transported according to the conditions stipulated in the contract;
Hoisting and transporting should be handled with care;
To ensure the integrity of the master carton, pay attention to waterproof and moisture;

This instrument is a precision laboratory equipment, please use both

hands to hold the bottom of the instrument when moving. The
Attention
instrument must be placed in the carton to be transported by crash
roll package.

The instrument should be prepared for the special waste containers,

the waste is only to be thrown into the container, the waste in the
container discharged shall be treated according to the laboratory
Biological risks which has biological risks provisions. For the risk of potential biological
infectivity, such as samples, reagents etc. Users should wear standard
laboratory protective clothing and gloves, and comply with the
laboratory safety operation regulations.

11. Production Date and Expiry Time

Date of production: See the lable
Service period: 3 years

12. Label

Symbols Description Symbols Description

Warning Fragile items

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 Biological risks Avoid moisture and keep dry

This direction up Referring to User Manual.

Manufacturer Electronic equipment waste

Double insulation Limit of humidity ≤90%

Limit of Temperature: Limit of atmospheric

-20℃～55℃ pressure: 50.0kPa~106.0kPa

For in vitro diagnostic use

Direct current
only

Serial port: used for LIS

RS232
transmission

13. Packing list

No. Description of goods Qty‘ Remarks

1 Main unit 1 unit LA-100

2 Power adapter 1 pcs AC 100~240V to DC5V 5.0A

3 QC card 1 set

4 Serial line 1 unit

5 Certificate of inspection 1 pcs

6 User Manual 1 pcs

7 Warranty Card 1 pcs

8 Packing List 1 pcs

14. Electromagnetic compatibility

Electromagnetic compatibility (EMC) is defined as a product, device, or system in normal work in its
electromagnetic environment and not to constitute an unsustainable electromagnetic disturbance to
anything in the environment.
Anti-EMI is the ability of a product, device or system in normal work in the presence of electromagnetic
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interference (EMI).
Handheld coagulation analyzer is designed and manufactured according to the existing standards of
electromagnetic compatibility and related requirements. Using an analyzer in the presence of an
electromagnetic field may result in reduced performance such as repeatability or accuracy. If this
phenomenon occurs frequently, it is recommended to check the analyzer's use environment to identify
possible sources of disturbance. The disturbances may come from other electrical devices used in the
same room or neighboring rooms, or from mobile phones, walkie-talkie, portable and mobile RF
communication equipment, or from nearby radio equipment, television or microwave transmission
equipment. If EMI interferes with the analyzer, it may be necessary to move the analyzer to another
location or take the appropriate EMI suppression measures.
The analyzer conforms to the requirements of the emission and anti-interference stipulated in national
standard GB/T 18268.It is recommended that the electromagnetic environment be evaluated before the
equipment is used.
14.1Prompt
The equipment is designed and tested according to the device of class A in GB4824. The device may cause
radio interference, and protective measures should be taken in the home environment.

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