Kodak DryView 8300 Service Bulletins page 46

CE Marking:
This equipment is part of a medical system and conforms to the medical safety and EMC in
EN60601-1-1, EN60601-1-2, and the 93/42/EEC, MDD (Medical Device Directive).
A Technical File and Declaration of Conformity with the Essential Requirements of the Medical Device
Directive have been prepared and signed by the appropriate personnel and are located at:
Kodak AG
Quality Services and Product Safety
70323 Stuttgart Germany
Telephone 49-0711-40-06-5291
FCC:
This device complies with the limits for a Class B digital device listed in Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause
undesired operation.
Industry Canada:
This Class B digital apparatus meets all requirements of the Canadian Interference-Causing
Equipment Regulations.
Cet appareil numérique de la Classe B respecte toutes les exigences du Règlement sur le matérial
brouilleur du Canada.
EU:
This equipment complies with the January 1996 EU Community EMC Requirements, per EN55011
Class B.
2. Installation
2-1. General
The 8600 is sold as the preferred printing choice for many Full Field Digital Mammography (FFDM)
OEMs. Currently, the big players in this market are GE, Lorad (Trex) and Fischer. While the basic
hardware installation is the same for all FFDM modalities, the image quality parameters established
during OEM qualifications may be different. The basic hardware installation (see Figure 1) consists of
a 9410 Print Server that is connected to the customer's network and receives FFDM DICOM images.
The 9410 then converts the images using 952 host protocol and sends them via a COPCIL board to
the 8600 digital input module.
The reason that the 9410 is being used as a print server between the modality and the 8600, is to
ensure maximum throughput. The Network Input Module used in the 8300 will work in the 8600.
However, the DICOM data transfer rate of the 8300 Network Input Module is too slow to handle the
very large FFDM images, which can be as large as 30 Mb. The typical ultrasound image is only
1/4 Mb, so the transfer rate is not an issue when using the 8300 Network Input Module in that
application. Because the 8600 printing speed is greatly reduced from that of the 8300 (see paragraph
1-8, Output), the data transfer rate needs to be optimum.