Coagulation Analyzer PT-M1-11

Coagulation Analyzer PT-M1-11  
  • Coagulation Analyzer PT-M1-11
274,50€ Including VAT(249,55€ without VAT)
 

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Reference: LP-P1M111

Description

The Coagulation analyzer PT-M1-11   is a portable in vitro diagnostic medical device, used in conjunction with a prothrombin time test strip, to measure the prothrombin time of fingertip capillary whole blood without anticoagulant treatment.

The Portable Coagulation Analyzer does NOT include test strips.

Technical characteristics:

- Comfortable: 1 drop of blood on the fingertip, result in 90 seconds

- Smart: Bluetooth connection, wireless transmission

- Memory: 200 sets of memory values, healthy control at all times

- Mobile Internet: Support mobile APP data analysis and management

- Size: 145mm × 69mm × 33mm

- Just 1 drop of whole blood For in vitro quantitative determination of CHOL, HDL, TRIG, LDL, CHOL/HDL

- Lepu PT-M1-11 Fingertip Blood PT Meter

- Bluetooth transmission 200 numbers of data storage

Indicated use:

The prothrombin time dipstick is used to clinically measure the level of the exogenous coagulation system and to monitor oral anticoagulant medications.

Patients :

People with abnormal blood coagulation or who are given oral anticoagulants for a long time and whose blood coagulation function needs to be monitored regularly.

Intended user:

- Medical professionals can use the product.
- Non-professionals (or their relatives) should use the product under the guidance of professional doctors. Test results should not be used to make diagnostic or therapeutic decisions.

Consumers should discuss any relevant questions or concerns with medical personnel after obtaining the test results.

Intended use environment : Hospitals or home

Operating environment:

- Ambient temperature: 10-35°C;
- Relative humidity: ≤80%;
- Atmospheric pressure range: 86kPa~106kPa;

Contraindications: None found.

Instructions:


- When a whole blood sample is dropped on the test strip, the blood sample gradually coagulates, its electrical conductivity changes accordingly, and as a result, the current value changes. The analyzer checks this process and calculates the prothrombin time of the sample, then displays the results on the screen.
- The prothrombin time test will vary greatly depending on the test method used, and the test results
they will be different. To balance this difference, the World Health Organization (WHO) has established the international normalized ratio (INR) as a standardized reporting method for monitoring PT in patients receiving oral anticoagulant drugs for treatment, therefore that 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).


Security instructions

- Read the instruction manual carefully before using it.
- The coagulation analyzer is used together with the corresponding prothrombin time test strip of prothrombin (electrochemical method) (the corresponding test strip is manufactured by Lepu Medical Technology (Beijing) Co., Ltd. and is sold separately).
- Keep the coagulation analyzer and the corresponding test strip out of the reach of children.
- Disinfect non-disposable blood collection devices and blood collection units.
- Do not reuse the test strip.
- The used test strip and lancet must be disposed of properly.
- The coagulation analyzer is only applicable to in vitro tests.
- Do not use the Coagulation Analyzer if it is not working properly or is damaged.
- Do not use the Coagulation Analyzer outdoors.

Precautions, limitations and the declaration of electromagnetic compatibility:

precautions

Follow the routine safety rules of laboratory operation. The test strip used must be
The used test strip must be disposed of as biological waste.
Remove the batteries if the equipment is unlikely to be used for any length of time.
Used batteries must be recycled in accordance with local regulatory requirements.
Do not touch the surface of the test area during use. For in vitro diagnostic use only.


sample collection

Use fresh capillary blood in the test.
When collecting blood from the fingertip, do not squeeze the fingertip too tightly.
Otherwise, interstitial fluid will be released into the blood, leading to inaccurate test results.
When collecting blood from the fingertip, make sure the fingertip is dry. Otherwise, residual alcohol will cause hemolysis and lead to inaccurate results.

Limitations of the test method

Like all experimental tests, any diagnosis or treatment decision cannot be based on a test result or method.
Prevent liquid from flowing into the analyzer.
The analyzer is a precision instrument. Damage or improper use may cause a malfunction. Be careful when using it.
The analyzer must be placed in a transport bag or secure container during transport.
Do not place the analyzer in an environment below -20°C or above 55°C.
When testing, do not insert any other brand of test strips into the analyzer.


Declaration on electromagnetic compatibility

The device complies with the emission and immunity requirements of EN 61326-1:2013 and EN61326-2-6:2013.
Evaluate the electromagnetic environment before using the device.
Do not use this device near strong radiation sources (such as unshielded RF sources). Otherwise, the normal operation of the device may be interfered with.

Accessories

The product includes the following accessories:
A coagulation analyzer, express operation card, instructions for use, Certificate of
Compliance, and four AA/1.5V alkaline batteries.


Grades:

Do not use other power adapters to connect this instrument, otherwise it may be damaged.
Four standard AA/1.5V alkaline batteries are used to power the instrument.

Warranty:

The product has a one year warranty

 

 


Attached files

 

Spare parts and accessories for this product

  • Prothrombin Reagent Strips for Coagulation Analyzer PT-M1-11 (25 tests)
  • Prothrombin Reagent Strips for Coagulation Analyzer PT-M1-11 (25 tests) Reference: LP-PTS101
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