Another consideration. This device, because of the huge magnetic fields
has to go into a fully shielded room, correct. Isn't that going to
provide relief from a regulatory perspective? From an operational
standpoint doesn't all of the monitoring and driving equipment have to
reside outside this room. Hope I'm not just being dense here. Obviously
not my bailiwick but it is an interesting scenario to me.
Topologically speaking I would say that the energy is still external to
the machine, even though the intention is to focus the energy into a
confined area "within" the equipment or more correctly within the
patient. In fact just like the emissions tests I have to perform on my
ITE equipment, the test is really confirming that you have focused the
energy as evidenced by no emissions present at the test receiving
antenna.
>From a purely personal perspective I'm certainly glad that the
configuration is as described - People go into a hole in the equipment -
rather than the reverse!
Gary McInturff
-----Original Message-----
From: [email protected] [SMTP:[email protected]]
Sent: Wednesday, July 01, 1998 10:10 AM
To: [email protected]
Cc: Lyle Luttrell
Subject: Re: NMR device classification
For those of you who haven't seen one, an NMR is a machine that
uses RF energy
to scan patients, who slide (almost entirely) into a hole inside
the machine.
The hole has an RF transmitting and receiving antenna.
If the energy stays within the scanning 'hole', and within the
outside
boundaries of the machine, is the energy still considered
'internal' to the
equipment?
Or is the fact that the system has an RF antenna beaming energy
into the hole,
mean that the energy is 'external' to the machine.?
On Wed, 1 Jul 1998 07:58:07 -0600, "Lyle Luttrell"
<[email protected]>
wrote:
>In classification for CISPR 11, one should consider whether the
RF
>energy is intended to perform a function related to the
intended use of the
>device. For Group 1 the RF energy is "necessary for internal
functioning
>of the equipment ", which implies that any external RF
radiation would be
>unintentional. While the Group 2 definition specifies
"treatment of
>material", it can be appropriate in many other cases where RF
energy is
>intentionally generated to perform the equipment function. For
an NMR
>diagnostic device, I think that a good case can be made that
the device
>should be Group 2.
>
>Lyle Luttrell
>Luttrell & Associates
>
>-----Original Message-----
>From: [email protected] <[email protected]>
>To: [email protected] <[email protected]>
>Date: Tuesday, June 30, 1998 11:47 AM
>Subject: NMR device classification
>
>
>>
>>
>>
>>We have some trouble about the classification according to
CISPR 11 of a
>>diagnostic NMR device. In my opinion the radio frequency
energy is NOT
>>genereted for treatment of material (human body). This
condition applies
>>only to therapy equipment that produce some change in the
body. For that
>>reason this is a group 1 device. Someone else disagree with
me, of course.
>>Does anybody have any opinion or experience about the matter?.
>>Thanks.
>>-------------------------------------------------------
>>ESAOTE S.p.A. Massimo Polignano
>>Research & Product Development Regulatory Affairs
>>Via di Caciolle,15 tel:+39.055.4229402
>>I- 50127 Florence fax:+39.055.4223305
>> e-mail: [email protected]
>>
>
>
>
--
Patrick Lawler
[email protected]
