Testing, trials, usage and disclaimers missing on documentation.

[kny5]

Hi Electronic Cats team,

I would like to contribute to the project by helping on the documentation process for the trials, testing for the design process, and for the documentation related to Open-Source medical devices, and regulations.

Key questions:
Is there any material available detailing the light source calibration, contrasting and trials used by the design team?
Is there a working paper relating the design, trials and usage?
Is the testing process and trials data opened and detailing how does the device reduces the risks or increases the success in medical I.V. interventions?

Notes:
As a medical related device an assessment on risks and responsibilities in the usage and proper instructions are needed with the release.

References:
https://www.appropedia.org/Open-source_3-D_printable_autoinjector:_Design,_testing,_and_regulatory_limitations
https://www.appropedia.org/IV_placement_and_Management

Kind regards,

[Marcelol52]

Hi @kny5,

We love to hear you are interested in contributing to our Vein Finder project.

We understand the value and importance of correct documentation, trials, and usage. We would greatly appreciate your input in these areas. 

To answer your questions:

• Both questions 1 and 2 can be answered together. We researched a few papers (linked below), but we mainly focused on the number of LEDs used and the wavelengths of the LEDs. We didn't go into much depth for calibration; our intention was to use PWM to control the brightness of each LED color and use that for real time calibration during usage. 
• As for trials, they were all internal and relatively basic. The benefits of using the device seemed apparent, so they were also not measured or documented. The device functioned to be able to see the veins on the patient, and that was all that we measured. 

I hope I have answered your questions.

Papers:

• https://pubmed.ncbi.nlm.nih.gov/31426370/
• https://www.researchgate.net/publication/340094027_RESEARCH_ON_VEIN_FINDER_INSTRUMENT_DESIGN_USING_TWOWAVELENGTH_OPTICAL_METHOD
• https://revistas.anahuac.mx/masciencia/article/view/1489/1472
• https://www.sciencedirect.com/science/article/pii/S2211379718318874
• https://iopscience.iop.org/article/10.1088/1742-6596/853/1/012019/pdf

[sabas1080]

Hola @kny5 gusto verte por aqui, estamos abiertos a tus contribuciones, el proyecto fue hecho para la makerfaire de cdmx como un proyecto DIY, estamos abiertos a colaborar

[Marcelol52]

We will be closing this incident for now. You can always reopen it or create a new one if you want to continue with the conversation. Thanks you.

[kny5]

Hi @ElectronicCats team,

Thank you for your responses and for sharing the relevant references. I appreciate the time taken to address my questions. @Marcelol52

However, I noticed that while the issue has been closed, the requested updates to the documentation have not been implemented. Proper documentation is critical, especially for a medical-related device, to ensure clarity, usability, and adherence to open-source principles. This includes:

Testing and Trials: Even if the trials were internal and basic, including a summary of the testing process and any observations (e.g., success rates, challenges, or limitations) in the documentation would help build trust and provide a foundation for others to contribute.

Risk and Usage Assessment: Documentation should include disclaimers and guidance on risks, responsibilities, and proper usage to align with best practices for medical devices.

Calibration and Design Details: While PWM calibration is a practical approach, detailing the design decisions (e.g., LED wavelengths and brightness control) in the documentation will help others understand and possibly improve upon the design.

It would be great to see these additions reflected in the repository's documentation so that future contributors and users can build upon the work. If there's anything specific you'd like me to help with, such as drafting or organizing the documentation, I’d be happy to contribute further.

Thank you for considering these suggestions, and I look forward to your response.

Kind regards,

[Marcelol52]

@kny5

Thank you for your feedback, we really appreciate your interest in the project. This project was made for a Maker Fair and therefore was only intended for educational and demonstration purposes. It was conceived as a proof of concept. We plan to continue with the project, but we don't have a defined timeline yet. We will try to add the relevant information that we already have for the time being.

[kny5]

@Marcelol52 Thanks for your quick response.
Better reasons I can't find to include in the documentation the testing, trials and risk assessment, since it's a global community the MakerFaire, the scope is for educational purposes, and the project is already available as a product in Hackster.io, it means more people would find the project and would like to use it and contribute.

Please add a section in your documentation listing the very basics of your procedures, It doesn't have to be an extensive entry.

For an easy to go action just copy paste the content from your hakster.io project entry inside the readme file in this repository. It won't be any burden, moreover it would serve for the portability and openness of your project.

If needed be I could add the entries in a pull request.

Kind regards,

For more on how to document open hardware take a look at:
https://curriculum.openhardware.space/articles/00-ohbasics/
You'll find my old profile there:
https://openhardware.space/community/mentors/antonio

[stale]

This is a message to remind you that your request has been pending for 5 days and awaits your comments.
Our agent would like to hear from you about your previous request to see if the difficulty you were facing has been resolved or if we can provide further assistance. Otherwise, if we do not hear back from you within the next three days, the issue will be closed.
Kind regards, Electronic Cats Support Team

[Marcelol52]

Requested information has been added. We will close this incident for now. If you have any other requests, comments or issues, let us know.

Once again, thanks a lot for your interest in the poject.