__________________ 

Hello emc-pstc list, 

I have a question concerning the integration of an RF tag reader or
Short-Range-Device operating in the 13,56MHz band 
in a medical printer. 

In order to understand the full issue one needs complete product information. 

It concerns a medical printer, that is, a printer that is is used in
hospitals, healthcare centers and 
possible at residential areas. For residential areas the printer operation is
by a healthcare specialist 
(e.g. radiologist that operates his own radiology business, but these cases
are limited). 

The printer is not portable (weight 75kg), but it is a  model. 

The printer is a complex machine that provides: 
- a twisted-pair LAN (Ethernet) interface 
- queueing and storage for images 
- image processing 
- manages many sensors, DC and stepper motors and electromagnetic clutches for
film transport 
- and a wirelessshort range RF system for the identification of the film type
(batch nr, film type, film processing data, ...) 

The RF device operates at 13.56MHz and is a small printed circuit board (PCB)
of 11cmx7cm. The antenna is 
integrated on the PCB (and is not removable). The interface to the printer is
over a RS232 interface. 
The RF tag reader is mounted in the film input cassette and is positioned to
align the tag in the film pack 
with the antenna of the reader. The maxiumum power of the RF device is 100mW(
and, by means of a relay, 10mW for Japan). 
The RF reader is part of the printer, it is just a module. 

>From a regulatory point of view we have Europ. The printer + RF device is
tested according to IEC60601-1-2:1993, class A 
for emissions. The RF device is tested according to ETSI (EN) standards. 


Our main focus is now on the US and we need to apply FCC rules. The code of
federal regulations part 47 part 15 
subpart A (=definitions), B (=unintentional radiators) and C (=intentional
radiators). 

I reference the FCC standard clause 15.3 (K), which concerns the definition of
a digital device. 

It states somewhere halfway: 

A radio frequency device that is specifically subject to an emanation
requirement in any other FCC Rule part 
or an intentional radiator subject to subpart C of this part that contains a
digital device is not subject to the standards for 
digital devices, provided the digital device is used only to enable operation
of radio frequency devicea nd the 
digital device does not control additional functions or capibilities. 

In this case the digital device  is the printer and the main operation is that
of a printing device. The RF device is a small 
internal part. The digital device (= the printer electronics) has many more
functions and control functions 
besides controlling the operation of the RF device and therefor it seems to
qualify (?) as a digital device. 
The RF device should be tested according to clause 15.225 of part 47 part  15
subpart C, which has details about the testing of the 
radio parameters of RF devices operating in the band 13.553-15.567MHz. 
The printer with the RF device should comply with emission limits of  part 47
subpart B class A or B. If one follows the 
classification then one can use class A. 

The above, however, is my line of reasoning. It has a focus on the fact that
the printer is a commercial non-portable digital device, which 
happens to include a RF device of which the radio type parameters have been
tested. 

However, there is an alternative line of reasoning: by including an RF device,
which requires class B emisison limits (see clauses 
15.207 & 15.209), the whole printer becomes a class B device. However, the
class B limits are for intentional radiators and not for 
digital devices! 


The question is simple: can we use class A emission limits for the printer +
RF tag reader? If we can not, what are the 
arguments why class A can not be used? 


I hope that you can help me to figure this one out. 


Kind regards, 

Jan Vercammen 
EMC engineer 






I have asked the RF device maufacturer and the maintain that the device should
be tested as   






Kind regards, 

Jan Vercammen 
Agfa-Gevaert NV, Belgium

Reply via email to