Consumer or Medical Grade Tablet to Receive Data from a Recording Module via WIFI

[Joho Zollo]

Dear All,

We need to use a tablet to receive data from a recording module via WIFI, and process the data. The medical tablets are rugged and quite expensive. I wondering if a consumer tablet such as iPAD would be accepted by IEC 60601 in any way.

Thanks in advance!

 

[Loekje]

Hi Joho,

I guess the reason you did not receive an answer yet is because you question seems a bit too general. As always it depends on your situation.

1) first the intended use, basic safety and essential performance: If there is any way that the software on your tablet could interfere with the essential performance or hamper the safety then yes, you must adhere to all applicable parts of the 60601. That means you do (amongst other test) the drop tests and end up with a rugged tablet.
We faced a somewhat same problem and just defined the recording module to have no essential performance whatsoever. Also the software could not interfere with the safety: the recording device was designed with intrinsic safety.
The basic operator safety of a tablet is not likely to pose a problem for a tablet of a renowned manufacturer. (Watch out if the tablet can be operated with a connected USB power supply though).

2) Then there is the place where your tablet is to be used. It is likely a part of your Medical Electrical System so your Tablet must comply to to the applicable standards concerning EMC and IP rating for OR/ICU/Home Use. Your consumer model must pass these tests. You will get your final answer at the test house, and hey: we even had certified medical PC's that were radiating 20dB above limits, so do not trust labeling. Only trust test reports.

I'm sure others can fill in gaps in this answer.

Bottom line is: there is a lot to be won at defining your system. After that, if it is critical, you might end up with a lot more cost by choosing the cheap solution.

Regards,
Loek

 

[shimonv]

Hi there,
The fundamental question is: does your tablet meet the definition of Medical Electrical equipment as per IEC 60601-1 or not?

If the answer is 'yes', then most likely the iPAD will not pass the electrical safety test. For instance, it's not likely that the Apple power supply will pass the dialectic strength test because it wasn't design for it.

If the answer is 'No', then you only need to comply with the standards for IT equipment, and the iPad should be good.

Attached is an extract of the relevant definitions from the IEC 60601-1 standard. It's form my private collection of RA/QA tips along the years.

Goodluck,
Shimon

P.S. Using WiFi is cool technology but it creates a lot of challenges in terms of data integrity and cybersecurity. That's why I wrote 'Good luck'.

 

[Joho Zollo]

Hi Loek,

Thank you very much for your help!

We have a battery powered Recording Module and a Dock Station (DS). Originally we wanted the tablet can be removable from the DS. Now the tablet is integrated into the DS and not removable. I guess now it is just a part of the medical device, and will not be treated specially.

Regards,
Joho

 

[Pads38]

Hi Joho,

As you suggest, with the tablet integrated into other parts of the medical device it becomes more likely that it would have to satisfy al of the 60601 requirements.

But remember, for electrical safety a device (medical or IT) must provide 2 MEANS OF PROTECTION (defined term). If, by risk analysis, you can be sure that only an OPERATOR will be in contact with your device then 2 x MOOP (operator protection) would be sufficient. If your device comes into patient contact then you would need 2 x MOPP (patient protection).

In the case of 2 x MOOP - these requirements are aligned with the requirements of 60950 (the IT standard), so electrically the consumer tablet could be used.

However, you would also need to consider other risks - say, liquid spillage. Depending on where your device was being used would drive this requirement. Operating theatres, for instance, are often wet, often with things like saline - would that rule out the use of a consumer grade tablet? For ward use think of the cleaning / disinfection requirements - would a consumer grade item be OK?

As an example - I would not now consider supplying a hospital cart computer with anything other than a fully cleanable keyboard. They are a known cross-infection risk.

 

[Joho Zollo]

Hi Joho,

But remember, for electrical safety a device (medical or IT) must provide 2 MEANS OF PROTECTION (defined term). If, by risk analysis, you can be sure that only an OPERATOR will be in contact with your device then 2 x MOOP (operator protection) would be sufficient. If your device comes into patient contact then you would need 2 x MOPP (patient protection).

In the case of 2 x MOOP - these requirements are aligned with the requirements of 60950 (the IT standard), so electrically the consumer tablet could be used.

We'll use an external medical grade AC/DC adapter and a switching regulator to bring the DC voltage down to +5V to charge the tablet. the AC/DC adapter has 2 x MOPPs.

 

[Joho Zollo]

The fundamental question is: does your tablet meet the definition of Medical Electrical equipment as per IEC 60601-1 or not?

Hi Shimon, it is not clear to me that if the tablet is ME because itself does have Applied Parts. The battery powered Recording Module does have AP, and it communicates with the tablet via wireless. Maybe if the tablet is used in patient environment, the it is ME. If the tablet is limited to use outside patient environment, then it is not ME? I really don't know. What is your answer?

 

[shimonv]

Hi Joho,
From what you are describing the tablet is not a medical electrical equipment because it's not in the patient environment. The whole purpose of IEC 60601-1 standard is to dictate additional safety requirements for a medical device that comes in contact ("applied part") with the patient and subsequently exposes him to risks associated with electricity.

To be sure, I advise you to consult with the testing lab.


BR,
Shimon

 

[Joho Zollo]

Many thanks to Loek, Shimon and Pads38.

You guys are very helpful. Now I have a clearer picture in terms of using a tablet in ME.

 

[Pads38]

Can I highlight that medical devices can still be medical devices if they are outside the patient environment.

Medical devices can still be medical devices even if they have no applied parts.

In the case of 60601 the definition is 3.63 - MEDICAL ELECTRICAL EQUIPMENT

electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and
b) intended by its MANUFACTURER to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability

NOTE 1 ME EQUIPMENT includes those ACCESSORIES as defined by the MANUFACTURER that are necessary to enable
the NORMAL USE of the ME EQUIPMENT.

I would suggest that your tablet still needs to meet the applicable requirements as being an accessory to a medical device.