LEPU MEDICAL PT-M1-11 Coagulation Analyzer Instruction Manual

PT-M1-11 Coagulation Analyzer
Instruction Manual Coagulation Analyzer
Instructions for use
Lepu Medical Technology (Beijing) Co. Ltd.

Statement

Thank you for choosing products manufactured by Lepu Medical Technology (Beijing) Co., Ltd.
Before installing or using the Coagulation Analyzer for the first time, please be sure to read all the documents accompanying the product carefully. This will be helpful for you to use this product better.
If this product is not operated according to the instructions and requirements of this manual, or the product is misused due to misunderstanding or other reasons, Lepu  Medical Technology (Beijing) Co., Ltd. (hereinaf­ ter referred to as “Lepu”) will not be liable for any loss arising therefrom.
Lepu has carefully reviewed and verified this manual, but we cannot guarantee that this manual has no errors or omissions. If any errors and inadequacies are found, please  contact the company’s customer service staff.
Lepu is committed to continuously improve product performance and service quality, and reserves the right to make changes to any product and software program described  in this manual and the contents of this manual without prior notice.
The purpose of this manual is to guide use of the product correctly. It does not represent any description of the hardware and software configuration of this product. For  product configuration, please check the contract (if any) related to this product, the packing list of the product, or consult the dealer who sold the product. The pictures in this manual are for reference only. If there is any discrepancy between an individual picture and the actual state of the product, the actual state of the product will prevail.
The contents of this manual are protected by copyright laws and regulations. Without prior written permission of Lepu, photocopies or written copies of this manual may not be made in any way. Transmis­sion of this manual in any form through any wired or wireless network, or translation of this manual into other languages are also prohibited.
During use, any inconsistency between the actual status of this product and the content described in this manual or inquires about any issues related to use this product and  the latest product information or to provide valuable opinions and suggestions, please contact the company directly. The contact method is as follows:
Lepu Medical Technology (Beijing) Co., Ltd.
Address: No. 37, Chaoqian Road, Changping District, Beijing
Production address: Building 7-1, No. 37, Chaoqian Road, Science
Park, Changping District, Beijing
Postcode: 102200
Customer service hotline: 010-80120666
Website: http://www.lepumedical.com

Product Introduction

1.1 Product description
Product name: Coagulation Analyzer
Product model: PT-M1-11
1.2 Intended use
This product is an in-vitro diagnostic medical device, which is used in conjunction with a prothrombin time test card. Clinically, prothrombin time (PT) is used to reflect the  status of extrinsic coagulation pathways and common pathways. This product is used to test prothrombin time (PT).
Patient population: people with abnormal blood coagulation or are administered oral anticoagulants over a long period and have their blood coagulation function needing to  be monitored regularly.
Intended user:

• Medical professionals can use the product.
• Non-professionals (or their families) should use the product under the guidance of professional doctors. Test results should not be used
  for diagnostic or therapeutic decisions. Consumers should communi­cate relevant questions or doubts with medical personnel after obtaining test results.
  Intended use environment: Hospitals or home.

Operating environment:

• Ambient temperature: 10-35C;
• Relative humidity: <80%;
• Atmospheric pressure range: 86 kPa–106 kPa;
  Contraindications: None found.

1.3 Operating principle
When a whole blood sample is dripped on the test card, the blood sample gradually coagulates, its electrical conductivity changes accordingly, and as a result, the current value changes. The analyzer tests this process and calculates the prothrombin time of the sample and then displays the results on the screen.
The prothrombin time test will vary greatly depending on test method used, and the test results will be different. In order to balance this difference, the World Health  Organization (WHO) has established the international normalized ratio (INR) as a standardized reporting method for monitoring the PT of the patients administered oral anticoagulant drugs for treatment, so the results measured with different thromboplastin reagents are comparable.
When performing the prothrombin time test, the Coagulation Analyzer reports the prothrombin time (PT) and the international normalized ratio(INR).

1.4 Safety instructions

• Please read the operation manual carefully before use.
• The blood coagulation analyzer is used in conjunction with the matching prothrombin time test card (dry chemistry method) (the matching test card is manufactured by  Lepu Medical Technology (Beijing) Co., Ltd. and is sold separately).
• Keep the blood coagulation analyzer and the matching test card out of the reach of children.
• Disinfect non-disposable blood collection devices and blood collection units.
• Do not reuse the test card.
• The used test card and lancet should be disposed of properly.
• The blood coagulation analyzer is only applicable to in-vitro tests.
• Do not use the blood coagulation analyzer if it does not work properly or has been damaged.
• Do not use the blood coagulation analyzer outdoors.

1.5 Precautions, limitations, and the statement on electromag­netic compatibility
1.5.1 Precautions

• Observe routine safety operation rules of a laboratory. The used test card should be disposed of as biological waste.
• Remove the batteries if it is unlikely the equipment will be used for a period of time.
• Used batteries should be recycled according to local regulatory requirements.
• Do not touch the surface of the test area during use.
• For in-vitro diagnosis only.

1.5.2 Sample collection

• Use fresh capillary blood in the test.

• When collecting fingertip blood, do not over-squeeze the fingertip.
  Otherwise, interstitial fluid will be released into the blood, resulting in inaccurate test results.

• When collecting fingertip blood, be sure that the fingertip is dry.
  Otherwise, residual alcohol will cause hemolysis and result in inaccurate test results.

1.5.3 Limitations of the test method

• Like all experimental tests, any diagnosis or treatment decision cannot be based on a single test result or method.
• Prevent liquid from flowing into the analyzer.
• The analyzer is a precision instrument. Damage or improper use may cause malfunction. Be careful to use it.
• The analyzer should be placed in a carry bag or secure container during transportation.
• Do not place the analyzer in an environment below -20°C or above 55°C.
• When performing the test, do not insert any other brands of test cards into the analyzer

1.54 Statement on electromagnetic compatibility

• The device meets the emission and immunity requirements of EN 61326 1.2013 and EN 61326-2-6.2013
• Evaluate the electromagnetic environment before using the device
• Do not use this device near strong radiation sources (such as unshielded RF sources). Otherwise, normal operation of the device may be interfered

Product Composition

2.1 Accessories
The product includes the following accessories
A Coagulation Analyzer, quick operation card, warranty card, instructions for use, Certificate of Conformity, and four AA1.5V alkaline batteries
Notes
Do not use other power adapters to connect this instrument, otherwise it may be damaged four standard AA/1.5\¥ alkaline batteries are used as the power supply for the  instrument
2.2 Product diagram ![LEPU MEDICAL PT-M1-11 Coagulation Analyzer

• Diagram 2](https://manuals.plus/wp-content/uploads/2023/05/LEPU-MEDICAL- PT-M1-11-Coagulation-Analyzer-Diagram-2.png)

Operation flowchart

Preparations for the test

Before using the Coagulation Analyzer, prepare the following items

• Coagulation Analyzer
• Peotvombin time (PT)test card
• Lancet
• Alcohol swab

Turning the Instrument On/Off

5.1 Connect the power supply
Place four AA/1.5V alkaline batteries in the battery chamber on the back of the instrument.
5.2 Turn on the instrument
After the instrument is turned on for the first time, the time setting interface will start after a “beep”. In the settings interface, you can set parameters. See 6.2 for details of that operations.

To perform the test immediately, insert a CODE card that matches the Prothrombin time (PT) test card into the CODE card slot of the analyzer. If no CODE card is  inserted, the screen will display a prompt to remind you of inserting a CODE card.

If a CODE card has been inserted, the analyzer will display the value of the CODE card, and enters the card insertion interface after 1s.
Under the card insertion interface, press the left key to quickly enter the time setting interface, and press the right key to quickly query historical data. See 6.4 for details of  these operations. If you do not do any test now, you can press “Power Off’ to turn off the instrument.

Note: The current battery level is displayed in real time in the upper right corner of the card insertion interface. If the battery level is low, the instrument will prompt “E001”  and the battery icon will blink constantly.
If the instrument is in sleep state, it can be awaked in the following way:

• When the On/Off button is pressed, the screen will show the card insertion interface

5.3 Turn off the instrument
In the card insertion interface, press “Power Off’, and the instrument will be turned off.
Note: The instrument automatically enters sleep state after it has been idle for more than 3 minutes.
In the sleep state, press the “On/Off button, and the instrument will enter the card insertion interface.

Set the instrument

6.1 Menu interface
When the instrument is in a sleep state, press the “On/Off’ button, and the system will enter the card insertion interface. Press the “Menu” button, and the menu interface  will appear.

6.2 Basic settings
In the basic settings interface, you can use the left and right buttons to set backlight, prompt tone and time. Press “OK” to start setting. Press “ESC” to return to the menu settings interface.

1. Backlight setting
   In the backlight setting interface, press the left or right button to turn the backlight on or off. Press “OK” to complete the setting and return to the basic settings  interface. If you want to cancel the setting, press “ESC.

2. Prompt tone setting
   In the prompt tone setting interface, press the left or right button to turn the prompt tone on or off. Press “OK” to complete the setting and return to the basic settings  interface. If you want to cancel the setting, press “ESC”.

3. Time setting
   In the time setting interface, you need to set year, month, day, hour, minute and second in sequence. The item to be set will blink. Press the left button, and the number  will decrease. Press the right button, and the number will increase. Press “OK”, and the setting of this item is completed. Press “Local Time”, and then the correct  numbers will be displayed.

6.3 User setting
In the user setting interface, you can carry out user modification and user selection settings.

1. User modification
   In the user modification interface, press the left or right button to select a user. After pressing “OK”, the selected user can be deleted or modified. If delete is chosen,  user data will be cleared. If modify is chosen, the user modification interface will start. See the “User modification” operation below for details.

2. User selection
   In the user setting interface, user selection can also be performed, so the user can identify the tester.
   If there is no record of current user, select “+” to add user and enter the username setting interface.
   In the username setting interface, the user can select an appropriate username consisting of 0-9 or A-Z by pressing the left and right button. A username cannot be  blank, otherwise the interface will display “Invalid username”. If the currently set username has already existed, the interface will display “Existing username”, you need  to reset the new username.

6.4 Data browsing
In the data browsing interface, historical data will be arranged in chronological order. You can use the left or right button to select the data to be viewed, and press “OK” to confirm the viewing.

6.5 Control test
The PT control solution is used in conjunction with the prothrombin time (PT) test card to verify the performance of the system.
It is recommended to perform two levels of testing for each control. See the control liquid manual for details of the control test operation information.
Please use the control liquid provided by Lepu Medical Technology (Beijing) Co., Ltd. to perform the control test.
6.6 Data deletion
In the data deletion interface, you can press the left or right button to choose whether to delete the data. If “Yes”, the product will perform data deletion, and the interface  will display the deletion progress bar.
If “No”, the product will return to the menu settings interface.

Test

7.1 Preparations

• If the product is used for the first time, place four AA/1.5V batteries in the chamber, and close the battery cartridge cover. Please pay attention to the battery polarity.
• Insert the CODE card from the prothrombin time test card packaging box into the CODE card slot of the instrument. (A CODE card is provided in each box of test  cards. Please be sure to use the CODE card with a matching number of the prothrombin time test card.)
• Press the “On/Off button. After test interface appears, the code will be displayed at the top right of the display. Please check whether the code displayed on the LCD is  consistent with that on the prothrombin time test card. If not, first, check whether the inserted CODE card and prothrombin time test card are taken from the same  box. If yes and the codes are still inconsistent, stop the test and unpack a new prothrom­ bin time test card for a new test.
• Take out a prothrombin time test card and insert the test card in the direction indicated by the arrow on the interface. If the card is inserted successfully, the system will  automatically enter the user selection interface. If the test card has been inserted into the instrument before it is turned on, the system will directly enter the user selection interface.

7.2 Heating
After the user identity is validated, the system will automatically enter a heating state.

After heating is complete, the screen will prompt to add the blood sample. You must complete the sample addition within 3 minutes.
Otherwise, it will cause an E008 error (sample addition timeout).

7.3 Blood sample collection
Blood can be collected with a disposable lancet (sold separately).
7.3.1 Improve blood circulation
Before blood collection, warm hands with hot water or near a hot plate. or massage the finger while keeping the hand below heart level.
7.3.2 Sample collection
Wipe the fingertip with alcohol. Collect blood after the alcohol has evaporated.

• Remove the lancet cap and firmly attach the end of the lancet to the part that has been disinfected.

• Gently press the ejector, and then with a sound of spring release, puncture is completed.
  Put the used lancet in an appropriate container.

• After the blood sample is added to the test card, use a sterile swab to press the puncture site to stop bleeding.

Notes:

• Collect capillary blood from the lateral edge of a finger because the least pain will be suffered in this way.
  After puncture, massage the finger from which blood will be collected until a blood droplet forms. Do not squeeze the finger forcibly.
  The addition of the blood droplet to the test strip must be completed within 15s after the finger is punctured. Blood sample addition beyond that time will result in false  test results because blood coagulation has already started.

7.4 Test
Keep the instrument level. Collect a blood droplet hanging from the fingertip and add it to the sample addition port of the test card. The instrument automatically starts  testing. During this test, do not move the instrument or test card and do not press the operation buttons on the panel

When the test is completed, the instrument will issue a beep” and then display the test results along with the patient number on the screen. Press ESC the instrument will  return to the main interface f the test card is not removed, it will prompt you to remove the test card

Note Test results, patient numbers, batch numbers, and date and time settings are automatically saved.The system can save up to 200 sets of results

7.5 Test results and notes

• Normal range
  Through a large number of healthy samples tested, the normality range of testing: INR is between 0.7-1.4.

• Abnormality range
  The treatment range for patients varies from person to person. The appropriate treatment range: INR is between 2 and 4.5, and may be below or above this range.

• Unexpected results
  When the test result is not in the expected range, it may be due to some special causes.
  Solution: When unexpected results are obtained, retest with a new test card. If you get repeated results, contact the doctor immediately.

7.6 End of test
After the test is completed, place the used test card in an appropriate container. When the instrument is not used, it is recommended to turn it off to save power.

Bluetooth function

When the Coagulation Analyzer completes a test, click the “Upload” button, and the Bluetooth on the instrument will be turned on automati­ cally to enable the instrument to  be connected to a phone.
Alternatively, after the test is completed, return to the card insertion interface and click the “Record” button to display the historical data.
Use the left and right buttons to select the data you want to view.
Press the “OK” button to view the data. After the data are displayed, click on “Upload”, and the Bluetooth of the instrument will be turned on automatically and the  instrument can be connected to the phone.

Cleaning

• Wipe the surface of the instrument gently with a damp cloth.
  If necessary, use a swab with a small amount of alcohol, absorbent paper, and a cloth to clean the instrument appropriately.

• The wiped portion should be completely air-dried and any lint or fluff remaining on the surface of the instrument should be removed.
  Note: To avoid system damage, please observe the following:
  1. Prevent liquid from flowing into the instrument.
  2. Do not spray anything into to the instrument. Do not immerse it in any liquid: it may damage the internal components of the instrument and as a result, it will not work properly.

Main technical parameters

2.0-4.5 (Deviation: ±0.8; r=>0.95)
4.6-6.0 (Deviation: ±1; r>0.95)
Repeatability (CV%)| INR: 0.7-6.0(=10.0%)
Preheating time| <3min
Temperature control| 37.0C±1.0C
Sample addition quantity| = 10uL
Test time| 90s
Power supply| 4 AA/1.5V alkaline batteries
Storage| 200 sets of data and the test date and time
Power-saving mode| The instrument will turn off
automatically if there is no any operation within 3 minutes.
Instrument dimension| 145mm69 mm33 mm (lengthwidthheight)
Display| 128128 LCD
Weight| About 160g (excluding the AA batteries)
Operating environment| 10-35C; humidity: <80%
Storage environment| 20–55C; humidity: <90% (no mist)
Service life| Three years
Production date| See the label

Interpretation of symbols

| Description
---|---
Manufacturer
Authorized representative in the European Community
Date of manufacturer
Use-by date
Serial number
Biological hazard
In vitro diagnostic medical device
Consult instructions for use
Temperature limit
Caution
Fragile, handle with care
Keep away from sunlight
Keep dry
Direct(battery) current

Maintenance

• The Pharmaceutical Affairs Law stipulates that the modification of medical instruments is prohibited.
• Maintenance personnel not authorized by the company shall not disassemble the instrument and perform maintenance.

Warranty

Lepu Medical Technology (Beijing) Co., Ltd. warranties for defects in materials and technologies within one year from the date of purchase.
This warranty cannot guarantee uninterrupted operation of the instrument.
Lepu Medical Technology (Beijing) Co., Ltd. does not make any other warranties and expressly disclaims any implied warranties of merchantability, non- infringement, or  applicability to a particular purpose.
The only parts which the user can replace or dismount are the batteries and the back cover of the battery cartridge. Tampering with other parts of the instrument, misuse of  the instrument or not using the instrument in accordance with the instructions for use will make the warranty invalid. This warranty does not apply to any damage arising from improper preservation, or accidents, alteration, tampering or misuse. Before returning any defective instrument, you must obtain an “Authorized Return” and return  directives given by Lepu Medical Technology (Beijing) Co., Ltd. Please phone us for technical support. The shelf life of this product: Three years.
Production date: See the label.
All liabilities of Lepu Medical Technology (Beijing) Co., Ltd. relating to the instrument, no matter any legal claims or any claims based on the fair use statement, are not  limited to the purchase price of the instrument. In any circumstances, Lepu Medical Technology (Beijing) Co., Ltd.’s joint liabilities include accidental, indirect, special, consequential, punitive damages or compensation, or any remedial measures taken by its distributors aware of the possibility of such claims or losses.

The manufacturer and after sales service unit

Manufacturer: Lepu Medical Technology (Beijing) Co., Ltd.
Address: No. 37, Chaoqian Road, Changping District, Beijing
Production address: Building 7-1, No. 37, Chaoqian Road, Science
Park, Changping District, Beijing
After-sale service: Lepu Medical Technology (Beijing) Co., Ltd.
Postcode: 102200
Tel: 010-80120666
Fax: 010 80120600
Website: http://www.lepumedical.com

Lepu Medical (Europe) Cooperatief U.A.
Address: Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The
Netherlands
Tel.: +31-515 573399
Fax: +31-515 760020
Document Number: CE-NXY-ln-0001
Preparation Date: 2019-8-1
Manual Version: Rev.02

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