Clinical evaluation of SPO2 accuracy/blood pressure/respiration/temperature

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  • Clinical evaluation of SPO2 accuracy/blood pressure/respiration/temperature: Product Name: Clinical evaluation of SPO2 accuracy/blood pressure/respiration/temperature Brand: Medlinket OEM/ODM: Yes *For more product details, check out the information below or contact us directly
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    Medlinket  has 17 years of experience in the medical device industry, focusing on clinical consultation and evaluation of blood oxygen/blood pressure/respiration/temperature for many years. Our professional technical and regulatory teams have decades of industry experience, and can carry out clinical evaluation of SPO2 accuracy in accordance with the regulatory requirements of  FDA, CE, and NMPA. We provide critical solutions for clinical evaluation of SPO2 accuracy, and manage all clinical research issues before and after the launch of a series of medical devices.

     

    Why do clinical evaluation of blood oxygen accuracy?

    Can’t the accuracy of SpO2 be verified with a blood oxygen simulator?

    ISO9919:2005 FF.4 shows: No simulator has proven to be competent as a calibrator for pulse oximeter equipment, because the process of light passing through human tissues is very complicated, and some attempts to create a more effective simulation of this complexity Work on the process calibrator is in progress, but no effective results have been achieved so far. Therefore, the most effective way to confirm the accuracy of blood oxygen measurement is to compare the reading with the value of blood gas analysis (the value of blood gas is determined by the concentration of several oxygenated hemoglobins in arterial blood).

    For details, please refer to EE.2.

     

    The blood oxygen clinical trial ”Med-linket” is not a clinical institution. Is the report valid?

    Medlinket took 3 years to develop a dedicated oxygen level (FiO2) simulator, SaO2 stability evaluation system and data acquisition system, and invested nearly one million yuan in precision instruments and equipment, and cooperated with the First Affiliated Hospital of Sun Yatsen University and the People’s

    Hospitals and other clinical institutions cooperate to conduct invasive and noninvasive clinical evaluation of SPO2 accuracy. Clinical institutions can produce reports in both Chinese and English for FDA, CE and NMPA  certification and registration.

    Clinical evaluation of SPO2 accuracy/blood pressure/respiration/temperature

    Compared with American laboratories, what advantages does Med-linket have?

    1) It can assist in the preliminary test to reduce the probability of failure in the formal test;

    2) The cost of the same test project is only half that of the US; American laboratories also charge consulting fees on time;

    3) The cycle, generally3or4months,reduces the communication time and equipment transportation time compared to the US;

    4) There is no issue of declaration of equipment entering or leaving the customs;

    5) 16 years of professional experience in the medical device industry, many years of experience in clinical consultation and verification of blood oxygen.

    Clinical evaluation of SPO2 accuracy/blood pressure/respiration/temperature

    What services can Med-linket provide?

    1) Algorithm verification and accuracy verification in research and development;

    2) Non-invasive SpO2 accuracy, blood pressure/respiration/temperature clinical evaluation consultation;

    3) Consultation on clinical evaluation of invasive SpO2 accuracy and blood pressure.

     

    Clinical trial process:

    Blood oxygen clinical accuracy clinical trial process

     [Clinical evaluation of the accuracy of blood oxygen SPO2]

    Guidelines for registration of blood oxygen accuracy: Guidelines for technical review of pulse oximeter registration (2017 revision)

    Clinical accuracy verification of blood oxygen accuracy: Appendix CC in YY0784-2010

    In addition to the clinical evaluation of blood oxygen accuracy, we can also provide a series of clinical evaluation consulting services for parameters such as blood pressure BP, body temperature TEMP, and respiratory RR, and provide a complete set of clinical marketing solutions~

     

     [Clinical Evaluation of Blood Pressure BP]

    Guidelines for registration of blood pressure: Guidelines for technical review of registration of electronic sphygmomanometers (oscillometric method) (2016 revision)

    Clinical verification of blood pressure: YY0670-2008 chapter G1 auscultation method

     

    [Clinical Evaluation of Respiratory RR]

    Respiratory clinical guidelines specifically refer to clinical evaluation guidelines

     

    [Clinical evaluation of body temperature TEMP]

    Clinical guidelines for body temperature specifically refer to guidelines for clinical evaluation.

    Contact us now to speed up the project~

    Let’s talk about your goals and challenges together, and see how Med-linket can help you.

     

    As a professional manufacturer of various quality medical sensors & cable assemblies, Med-linket is also one of the leading suppliers of Clinical evaluation of SPO2 accuracy/blood pressure/respiration/temperature in China. Our factory is equipped with advanced equipment and many professionals. With FDA and CE certification, you can rest assured to buy our products made in China at reasonable price. Also, OEM / ODM customized service are also available.

     

    If you need more information, please feel free to contact us: marketing@med-linket.com.

     

    *Disclaimer: All the registered trademarks, product names, models, etc. shown in the above contents are owned by the original holder or the original manufacturer. This is only used to explain the compatibility of the MED-LINKET products, and nothing else! All the above information is for reference only, and should not be used as a working guide for medical institutions or related units. Otherwise, any consequences will be irrelevant to the company.

     

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