Electrosurgery Emission Compatibility - Patient monitoring equipment

R

royal77

#1
Hi,
We are developing a patient monitoring equipment(ECG, NIBP) which we intend to use along with Electrosurgery equipment. As per 60601-2-27 (ECG) and 60601-2-30 (NIBP) standards, we need to meet a couple of testsfor Electr-surgery compatibility. And we are complying with these tests. These standards also have 60601-2-2 (HF surgical equipment) as normative reference. In 60601-2-2 standard, some tests are given as guidance tests in annexure (Anex-BB) which manufacturer can use to check compatibility with the emissions from Electrosurgical equipments.

I was told that, we have to mandatorily qualify these tests also in order to comply with Electr-surgery compatibility. Can anybody provide information on whether these tests are mandatory or voluntary for complaince.

Thanks
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Can any medical device folks here help with this one? My Thanks in advance!
 

Peter Selvey

Staff member
Super Moderator
#3
In modern regulations, there are no mandatory standards, but you would have to justify if you don't comply with a harmonised or recognised standard. This might be tough to do for some subjects.

However, there is some conflicting information in the particulars on this subject that might be sufficient evidence to say that protection is optional (for reference, I have been heavily involved in the assessment of patient monitors for CB scheme, MDD and voluntary test reports, and I am working on equipment for testing against particulars like IEC 60601-2-27, IEC 60601-2-30 etc, if you are interested in information on, for example, pacemaker related tests, let me know via the contact section).

Note that new term for electrosugery is "HF surgical equipment"; all IEC based standards are being updated to use this term, but I will use "ESU".

The summary as I can see is:

IEC 60601-2-27:2005 (ECG) states that you must have protection against ESU noise; normal operation should resume normal operation within 10s. The draft standard (2009) does not change this aspect.

IEC 60601-2-30:1999 (NIBP) says this is optional, if claimed you test, using the same test as in IEC 60601-2-27. This standard has been replaced (IEC 80601-2-30:2009, not yet recognised in regulations), but the new standard is unchanged for this point.

IEC 60601-2-34:2005 (IBP) says again optional; if claimed, test (10s return).

IEC 60601-2-49:2001 (patient monitor) has no requirement. A new draft standard (dated 2009) has again the optional 10s recovery test.

ISO 9919:2005 (SpO2) has no requirement in this regard.

EN 12470-4:2000 (Temp) has no requirement for ESU noise.

So, all the standards apart from IEC 60601-2-27 refer to this as optional, or have no requirement. I do not know why IEC 60601-2-27 is "mandatory" and it makes no sense that one function of a multiparameter monitor must withstand ESU noise, but other functions are optional.

I also know that most patient monitor manufacturers have optional ECG cables (ESU type, non-ESU type), the ESU type having series inductors to limit HF currents (e.g. 400kHz and above). It could be interpreted that the non-ESU types might be illegal in Europe, but as far as I am aware, they are still being sold.

Finally note that ESU noise immunity is only one aspect. Protection against ESU burns is also important. This appears to be optional in all standards (including IEC 60601-2-27); but there is no test for this. If you are interested I can suggest tests based on IEC 60601-2-2 that would show your equipment restricts HF current to below, say 50mA @ 400kHz, which should be more than enough to limit the risk of burns.

Hope this helps - Peter
 
R

royal77

#4
Thankyou for your elaborate reply.
Actually, we do have input impedance to restrict from defibrillation and HF surgery currents. I am not sure if we have done some testing regarding that. I request you to please suggest the test from -2-2 to make sure that the protection is sufficient. I understand that this is also a voluntrary test.

Also, can you please clarify that, if we want to claim compatibility with HF surgical equipment and if we want to add this statement as part of the IFU (user manual), then whether we should mandatorily comply with the tests given in Annexure-BB (involving using an actual generator and wrapping the cord of the monopolar hf surgical instrument: 1) around the enclosure of the equipment being tested, 2) around the power cord and 3) around the accessory cables).

Thanks for your time and suggestions.
 

Peter Selvey

Staff member
Super Moderator
#5
For a test for burns, I would need to prepare some research and diagrams, so out of the scope of this thread - can you contact me directly at "peter.selvey(at)medteq.jp"

The testing specified in Annex BB of IEC 60601-2-2:2006 is informative, so it has no mandatory basis. However, under the MDD (for example), if you claim compatibility with HF surgical equipment, you would still need to have to evidence to back the claim; this would almost certainly involve some kind of verification testing with a real ESU. In the absence of a standard, Annex BB makes sense.

Note that test results can be highly dependent on the HF surgical equipment used. Valleylab, for example, produce a high quality stable output with fewer harmonics, whereas lower cost ESU manufacturers outputs are extremely noisy, unstable and unpredictable. I would use Valleylab, on the grounds that there is also an obligation on the ESU side to limit the noise as far as possible.
 
Last edited by a moderator:
R

royal77

#6
Thankyou for your suggestions.
I will suggest my team to verify the tests given in 60601-2-2 and have the record. I will confirm if the tests against burns are already done or not and contact you if required at your email.
 
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