Re: [bmelist] Trumpf Pendants

[Michael Smith]

Hi all,

If the device is treated as a permanently connected medical device (with 
auxiliary power outlets like, say a ventilator might), then perhaps it may be 
tested under AS3551, which allows:

"B8.1 (General) ...In the performance of these tests on Class I equipment 
during acceptance testing, where instances are encountered of exposed metal 
that appears to be inadequately earthed, ...consultation shall occur with the 
manufacturer to determine if this is an intended outcome of the design."

Whether the earth pin counts as "exposed metal" in this context, and whether 
the auxiliary outlets are sufficiently labelled etc. may be debatable.

Regards,

Michael C. Smith, PhD
Service Manager - Central Australia
Medical Equipment Management Australia Pty Ltd
Ph - 08 8951 7883
Mob - 0418 446 988
The information contained in this message is confidential and may be legally 
privileged. The message is intended solely for the addressee(s). If you are not 
the intended recipient, you are hereby notified that any use, dissemination, or 
reproduction is strictly prohibited and may be unlawful. If you are not the 
intended recipient, please contact the sender by return e-mail and destroy all 
copies of the original message.



-Original Message-
From: bmelist-boun...@bme.asn.au [mailto:bmelist-boun...@bme.asn.au] On Behalf 
Of Michael Flood
Sent: Tuesday, 24 January 2017 8:57 AM
To: Trevor Riessen; 'Porter, John R (THS)'
Cc: bmelist@bme.asn.au
Subject: Re: [bmelist] Trumpf Pendants

Good morning all

I think it's questionable whether they are a medical device, but if the 
manufacturer believes they are and includes them on the ARTG, then so be it.

However, just because they believe the pendants are a medical device, that 
certainly does not exclude them from the requirements of AS/NZS3003, regardless 
of what the company may think.  3003 is all about ensuring the safety of the 
environment, and compliant earthing is a part of that.

Regards

Michael Flood

Principal
Locus Consulting Pty Ltd
Email:  m...@locusconsulting.net.au
Phone:  +61 (0)2 6112 8325
Mob:+61 (0)40 1147 605



-Original Message-
From: bmelist-boun...@bme.asn.au [mailto:bmelist-boun...@bme.asn.au] On Behalf 
Of Trevor Riessen
Sent: Tuesday, January 24, 2017 9:34 AM
To: Porter, John R (THS) 
Cc: bmelist@bme.asn.au
Subject: Re: [bmelist] Trumpf Pendants

Hi John

While I am not familiar with the Trumpf brand, (interesting resemblance to 
TRUMP), and I am not aware if the connection between the EPJ and the top of the 
pendent is compliment, I do agree with your interpretation for a second 
connection to the metal surrounds.
Does the pendant itself have TGA approval as a medical device?

We had similar issues with the earthing of Stryker pendant, signal outlet metal 
surrounds, but were advised that as they had TGA approval as a medical device 
it was outside the scope of 3003:2011. (The LV outlets did however comply in 
that pendent, and I believe they were still within the scope of
3003)

I would be checking out the compliance of connections at the top of the pendent 
and earthing conductors/connections within the pendent?

Good luck

Trevor Riessen
Sent from my iPhone

> On 24 Jan 2017, at 7:32 am, Porter, John R (THS)
 wrote:
> 
> Hi,
> 
> I'm looking for some feedback on Trumpf pendants, the ones we have are 
> a
TruPort Supply Unit.
> 
> The issue we are finding is that it is difficult to get the earth in 
> the
socket outlet to pass AS/NZS 3003:2011 value required of 0.1 ohm.
> 
> Has anyone else experienced this problem? If so how did you improve 
> the
earthing?
> 
> Also the way the socket outlets are earthed don't appear to me to meet 
> the
requirements of AS/NZS 3003:2011 page 42 Figure 10. Only one earth has been 
used to earth the socket outlet and the metal surround that holds the socket 
outlet. To me the socket outlet modules in the pendant contact structural steel 
through the metal in the pendant, therefore there should be an earth from EP 
junction to the socket outlet earth and a separate earth from the EP junction 
to the metal surround that holds the socket outlet.
> 
> Please correct me if my interpretation is wrong. Any advice would be
appreciated.
> 
> 
> Regards,
> 
> John
> 
> 
> John Porter
> Team Leader Engineering Services
> Building & Engineering
> Launceston General Hospital
> 
> Mob: 0419146979
> Ph: 03 67776433
> Fx: 03 6348 7430
> 
> Email: john.por...@ths.tas.gov.au<mailto:john.por...@ths.tas.gov.au>
> 
> 
> 
> 
> 
> CONFIDENTIALITY NOTICE AND DISCLAIMER
> The information in this transmission may be confidential and/or 
> protected
by legal professional privilege, and is intended only for the person or persons 
to whom it is addressed. If you are not such a person, you are warned tha

Re: [bmelist] Trumpf Pendants

[Michael Flood]

Good morning all

I think it's questionable whether they are a medical device, but if the
manufacturer believes they are and includes them on the ARTG, then so be it.

However, just because they believe the pendants are a medical device, that
certainly does not exclude them from the requirements of AS/NZS3003,
regardless of what the company may think.  3003 is all about ensuring the
safety of the environment, and compliant earthing is a part of that.

Regards

Michael Flood

Principal
Locus Consulting Pty Ltd
Email:  m...@locusconsulting.net.au
Phone:  +61 (0)2 6112 8325
Mob:+61 (0)40 1147 605



-Original Message-
From: bmelist-boun...@bme.asn.au [mailto:bmelist-boun...@bme.asn.au] On
Behalf Of Trevor Riessen
Sent: Tuesday, January 24, 2017 9:34 AM
To: Porter, John R (THS) 
Cc: bmelist@bme.asn.au
Subject: Re: [bmelist] Trumpf Pendants

Hi John

While I am not familiar with the Trumpf brand, (interesting resemblance to
TRUMP), and I am not aware if the connection between the EPJ and the top of
the pendent is compliment, I do agree with your interpretation for a second
connection to the metal surrounds.
Does the pendant itself have TGA approval as a medical device?

We had similar issues with the earthing of Stryker pendant, signal outlet
metal surrounds, but were advised that as they had TGA approval as a medical
device it was outside the scope of 3003:2011. (The LV outlets did however
comply in that pendent, and I believe they were still within the scope of
3003)

I would be checking out the compliance of connections at the top of the
pendent and earthing conductors/connections within the pendent?

Good luck

Trevor Riessen
Sent from my iPhone

> On 24 Jan 2017, at 7:32 am, Porter, John R (THS)
 wrote:
> 
> Hi,
> 
> I'm looking for some feedback on Trumpf pendants, the ones we have are a
TruPort Supply Unit.
> 
> The issue we are finding is that it is difficult to get the earth in the
socket outlet to pass AS/NZS 3003:2011 value required of 0.1 ohm.
> 
> Has anyone else experienced this problem? If so how did you improve the
earthing?
> 
> Also the way the socket outlets are earthed don't appear to me to meet the
requirements of AS/NZS 3003:2011 page 42 Figure 10. Only one earth has been
used to earth the socket outlet and the metal surround that holds the socket
outlet. To me the socket outlet modules in the pendant contact structural
steel through the metal in the pendant, therefore there should be an earth
from EP junction to the socket outlet earth and a separate earth from the EP
junction to the metal surround that holds the socket outlet.
> 
> Please correct me if my interpretation is wrong. Any advice would be
appreciated.
> 
> 
> Regards,
> 
> John
> 
> 
> John Porter
> Team Leader Engineering Services
> Building & Engineering
> Launceston General Hospital
> 
> Mob: 0419146979
> Ph: 03 67776433
> Fx: 03 6348 7430
> 
> Email: john.por...@ths.tas.gov.au<mailto:john.por...@ths.tas.gov.au>
> 
> 
> 
> 
> 
> CONFIDENTIALITY NOTICE AND DISCLAIMER
> The information in this transmission may be confidential and/or protected
by legal professional privilege, and is intended only for the person or
persons to whom it is addressed. If you are not such a person, you are
warned that any disclosure, copying or dissemination of the information is
unauthorised. If you have received the transmission in error, please
immediately contact this office by telephone, fax or email, to inform us of
the error and to enable arrangements to be made for the destruction of the
transmission, or its return at our cost. No liability is accepted for any
unauthorised use of the information contained in this transmission.
> ___
> bmelist mailing list
> bmelist@bme.asn.au
> http://lists.bme.asn.au/mailman/listinfo/bmelist
___
bmelist mailing list
bmelist@bme.asn.au
http://lists.bme.asn.au/mailman/listinfo/bmelist

___
bmelist mailing list
bmelist@bme.asn.au
http://lists.bme.asn.au/mailman/listinfo/bmelist

Re: [bmelist] Trumpf Pendants

[Trevor Riessen]

Hi John

While I am not familiar with the Trumpf brand, (interesting resemblance to 
TRUMP), and I am not aware if the connection between the EPJ and the top of the 
pendent is compliment, I do agree with your interpretation for a second 
connection to the metal surrounds.
Does the pendant itself have TGA approval as a medical device?

We had similar issues with the earthing of Stryker pendant, signal outlet metal 
surrounds, but were advised that as they had TGA approval as a medical device 
it was outside the scope of 3003:2011. (The LV outlets did however comply in 
that pendent, and I believe they were still within the scope of 3003)

I would be checking out the compliance of connections at the top of the pendent 
and earthing conductors/connections within the pendent?

Good luck

Trevor Riessen
Sent from my iPhone

> On 24 Jan 2017, at 7:32 am, Porter, John R (THS)  
> wrote:
> 
> Hi,
> 
> I'm looking for some feedback on Trumpf pendants, the ones we have are a 
> TruPort Supply Unit.
> 
> The issue we are finding is that it is difficult to get the earth in the 
> socket outlet to pass AS/NZS 3003:2011 value required of 0.1 ohm.
> 
> Has anyone else experienced this problem? If so how did you improve the 
> earthing?
> 
> Also the way the socket outlets are earthed don't appear to me to meet the 
> requirements of AS/NZS 3003:2011 page 42 Figure 10. Only one earth has been 
> used to earth the socket outlet and the metal surround that holds the socket 
> outlet. To me the socket outlet modules in the pendant contact structural 
> steel through the metal in the pendant, therefore there should be an earth 
> from EP junction to the socket outlet earth and a separate earth from the EP 
> junction to the metal surround that holds the socket outlet.
> 
> Please correct me if my interpretation is wrong. Any advice would be 
> appreciated.
> 
> 
> Regards,
> 
> John
> 
> 
> John Porter
> Team Leader Engineering Services
> Building & Engineering
> Launceston General Hospital
> 
> Mob: 0419146979
> Ph: 03 67776433
> Fx: 03 6348 7430
> 
> Email: john.por...@ths.tas.gov.au
> 
> 
> 
> 
> 
> CONFIDENTIALITY NOTICE AND DISCLAIMER
> The information in this transmission may be confidential and/or protected by 
> legal professional privilege, and is intended only for the person or persons 
> to whom it is addressed. If you are not such a person, you are warned that 
> any disclosure, copying or dissemination of the information is unauthorised. 
> If you have received the transmission in error, please immediately contact 
> this office by telephone, fax or email, to inform us of the error and to 
> enable arrangements to be made for the destruction of the transmission, or 
> its return at our cost. No liability is accepted for any unauthorised use of 
> the information contained in this transmission.
> ___
> bmelist mailing list
> bmelist@bme.asn.au
> http://lists.bme.asn.au/mailman/listinfo/bmelist
___
bmelist mailing list
bmelist@bme.asn.au
http://lists.bme.asn.au/mailman/listinfo/bmelist