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Medical watch Class II (AP Type CF) with USB connection

#1
Hello all,

I was looking in the forum because there are so many medical device topics using a USB interface. Unfortunately, I'm not sure if I was able to answer my own question. Your help would be much appreciated.

We have a watch that contains an electrode (ECG measurement) on the wrist side. So, definitely, it would be a CF applied part. There is only one interface in it, the USB connection that will allow charging a lithium battery and the USB interface to transfer data from the device. The device is intended to be self-powered while being in use.

I intended to provide a certified external AC-DC power supply, 2 MOPP compliant for charging the device. For the data transfer, it would require the watch to be connected to a PC.

The way the connection is located will prevent the patient from using it while the watch is charging. We intend to use some pogo pins connector to reach 4 exposed pads under the watch (+5, GND, D+, D-). However, the electrode could still be reached if used during the charge.

I'm trying to keep the watch as small as possible.

Here my questions,

1- Knowing that the personal computer should at least be compliant with IEC 60950-1, I presume that we still have to have one MOPP between the electrode and the USB connection?

2- If I'm able to hide the electrode underneath the watch while charging it completely, should it be enough to remove the need for additional isolation?

3- If I replace the USB data transfer with a Bluetooth connection and use a connector for a dedicated power inlet with a medical-grade PSU, it would be the easiest solution, I presume?

Thank you for your help !
 
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#2
Hello all,

I was looking in the forum because there are so many medical device topics using a USB interface. Unfortunately, I'm not sure if I was able to answer my own question. Your help would be much appreciated.

We have a watch that contains an electrode (ECG measurement) on the wrist side. So, definitely, it would be a CF applied part. There is only one interface in it, the USB connection that will allow charging a lithium battery and the USB interface to transfer data from the device. The device is intended to be self-powered while being in use.

I intended to provide a certified external AC-DC power supply, 2 MOPP compliant for charging the device. For the data transfer, it would require the watch to be connected to a PC.

The way the connection is located will prevent the patient from using it while the watch is charging. We intend to use some pogo pins connector to reach 4 exposed pads under the watch (+5, GND, D+, D-). However, the electrode could still be reached if used during the charge.

I'm trying to keep the watch as small as possible.

Here my questions,

1- Knowing that the personal computer should at least be compliant with IEC 60950-1, I presume that we still have to have one MOPP between the electrode and the USB connection?

2- If I'm able to hide the electrode underneath the watch while charging it completely, should it be enough to remove the need for additional isolation?

3- If I replace the USB data transfer with a Bluetooth connection and use a connector for a dedicated power inlet with a medical-grade PSU, it would be the easiest solution, I presume?

Thank you for your help !
I found an isolated DC-DC converter that seems to provide two MOPP (LTM2894CY#PBF ). I think having a docking with this digital and power isolator would solve my problem. It would guarantee protection from any other devices from my USB protector.

Any thought, anyone?
 
#3
You probably already noticed that LTM2894 supports only Full/Low Speed USB. If data speed is not a problem then it would make sense to use it.
 

sreibs

Starting to get Involved
#4
Hi @SebastienBoisvert . For a different I have the same issue. We have an applied part, not able to isolate 1 MOPP. We started with a USB connector to charge the battery which involve a risk to use "non medical" power supply (we do not need data transfert). We decided to move to a dedicated medical power supply with a DC jack as a connector, but the lab said that it is still a too common connector and the risk to use a "non medical" power supply is still not mitigated.

You said "dedicated power inlet with a medical-grade PSU, would be the easiest solution ", what kind of dedicated power inlet do you talk about ? Do you have any ref to share ?

Thank you !
 
#5
Hello @sreibs,

In our application, I plan to use the LTM2894 from Analog Device to isolate my device from any power supply. We were thinking to provide a custom docking station for our watch. In this case, the docking can have pogo pins and the watch would require only have some exposed pads.


Having a docking station may help you if you can afford it. We were thinking also to hide the 'applied part' while charging (the metal electrode could be hidden by the docking).


Good luck !
 

sreibs

Starting to get Involved
#8
We are considering it also. We don't know this technology, we have to learn first. If you have some knowledge, I would be interested to have your feedback as a starting point.

Best regards
 
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