operator manual & MR compatibility
I ordered your product and I have some questions, I would appreciate if you could help.
I see that on your website the operator manual/ Labelling of the device with its intended use (e.g. placement on the patient) is not shared, I only found the electronic specification.
Could you please share any formal vendor document that would show that the MMR device intended for use as a wearable sensor for human motion sensing?
Is the MMR a medical device?
Is it possible to use the device in an MR environment?
MMR is not a medical device.
We are currently working on getting a Class 1 and Class 2 certification for one of our MMR kits (but it is not necessary for you).
You can use the MMR in an MR environment; many of our users have done so. Just understand it can be used to measure but it cannot be used for assessments (as a medical device).
As far as labels, since it is an electronic measuring device, the only label you need is the FCC/CE/IC IDs and paperwork already provided. The CE certs are in our documentation section. The FCC/IC labels are inside the case of the MMR. You need to make sure those #s and certs are available in your product.
Let me know if you have any other questions.
Thank you Laura for your reply,
I found the FCC/CE/IC labels but I did not manage to download the CE certificate from the documentation section.
Could you please share it?
You can download it but I think you have to copy paste the link in a separate window without the #s after the .zip.
It's weird! I will see if I can fix the links soon.
Ok thank you.
I tried the following link but it still does not work.
Right click and save link as
Thank you but it still does not work.
I would appreciate if you could send me the document as attachment to this conversation.
Thank you very much,
This has already been updated on the website.
About bio compatibility, does the MMR device external surface made from standard materials acceptable for casual contact? What are those materials?
We don't do direct contact to the body with our sensors. That's why we sell accessories.
All body contact is either made with our bands (which are made of safe materials such as silicone or neoprene) or single use adhesives which are made by 3M and are FDA cleared.
The cases are made of ABS plastic.
You are welcome to add materials that are safe to the body yourself. Many of our customers make their own cases for example (or coat the PCBs in epoxy).
The MMR has been lab tested and is safe to be "near" the body. This test is focused on radiation (for the bluetooth antenna) and NOT bio compatibility.
I have two other questions:
1. About the Neoprene Sleeve that you provide, did you make tests to prove that this accessory doesn't change the output data from the sensor and it is reliable as much as the sensor by itself?
2. Is it possible that there is a difference in the Bluetooth signal reception between iphone and android?
It found out that with two iphone devices the iphone could not read the signal from the sensor from 3-4m whereas with the android it was from more than 10m, as expected.
Do you have any authorization on standards for tests performed on a Lithium battery?
Our CE certification included the battery safety test.
Additionally, the battery vendors we work with provide us with their MSDS and other available certifications.
That being said, we change batteries often as battery vendors availability fluctuates in the supply chain.
Firstly the MMRL is working super well, congrats on that! I would like to have the MSDS for the battery inside the MMRL (15 units bought on March of this year). Currently, I cannot transport the sensors to another country without it (CE certificate is not accepted). Thank you!
Br, Pedro Valadao.
Here you go.
Thank you Laura!