GE Advantium CT9800, Technical Publications

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GE MEDICAL SYSTEMS CT 9800 QUICK SYSTEM
Rev. 3
Direction 18000
4-1-2
1-2. System and Option Component Identification
Table 4-1-1 lists system component model numbers. The table should be used as follows;
(a) to determine the components that require product locator cards
(b) to determine which components are H.H.S. certified
Table 4-1-2 lists component model numbers of options to the CT system. Its use is the same as Table 4-1-1.
Table 4-1-3 lists option nameplates which are added to a system or option component to identify that the
component has been modified by the addition of a cataloged option. Option nameplates are not serialized, and
are not tracked with product locator cards.
Product Locator Cards are shipped with all items listed under the columns labeled COMPONENT and MODEL
FOR SERIALIZATION (Table 4-1-1). The procedure for handling the product locator cards is published in P & P
bulletin P-3-2. Installation cards are to be mailed to;
General Electric Medical Systems Operation
Product Locator File W-507
P.O. Box 414
Milwaukee, WI 53201
1-3. H.H.S. Certification; Field Tests; and Record Forms
For H.H.S. certified components, refer to the column in the component identification tables labeled H.H.S.
Certification. All components with an X in this column have a nameplate with the statement or its equivalent
“COMPLIES WITH RADIATION PERFORMANCE STANDARDS . 21CFR SUBCHAPTER J ” This column is
further subdivided into three columns labeled TV, LASER, and X-RAY. An X in the ’TV’ column indicates that the
nameplate statement relates to Part 1020.10 of the regulations. An X in the ’LASER’ column indicates that the
nameplate statement relates to Part 1040 of the regulations. Neither of these sections require special reporting
by the assembler. A letter in the ’X-RAY’ column, however, means that the respective component is certified
under section 1020.30 as ’Diagnostic X-Ray systems and their major components’, and must be reported on form
FD-2579. The letter designates the code for the type of certified component. Specific instructions on reporting of
these certified components are contained n the notes to Table 4-1-1.
On August 31, 1984, 21 CFR sections 1020.30 were revised and a sub-section 1020.33 titled “Computed
tomography (CT) equipment” added. On November 29, 1984 part of the revised regulations requiring publication
of Dose Information became effective. On September 3, 1985 all of the revisions to 1020.30 including 1020.33
became effective. The additional requirements include providing a Quality Assurance Phantom, means to
measure image performance, representative images, CTDI information, cradle accuracy, scan plane indication,
and a system level nameplate.
To identify CT systems which have been manufactured after September 3, 1985, and are subject to the new
regulations; the top level nameplate of the Gantry (Model 46-220800Gx) has been H.H.S. certified and serialized.
This is now used as a system level nameplate. The new regulations apply if the manufactured date on this
namplate is September, 1985 or later. This is irregardless of the manufactured date on any of the other certified
components that are part of a particular CT system.
Table 4-1-4 lists H.H.S. Field Tests for the CT-9800 and CT-9600. Use this table as a reference to locate the
specific test procedure in the CT Service Documentation. Note that some tests are not applicable to systems
which were manufactured before September, 1985; or after August, 1985. Note also that the 2% SID test
requirement was discontinued in November, 1986 for systems manufactured before September, 1986.