MAMMOMAT Novation DR
SP
Update Instructions SP014/04/S
Title: Fixation of control console
Reason for update: X Safety
Urgency: Immediate X Within two (2) weeks
Update materials required? X Yes No
Materials free of charge? Yes X No
Return of parts? Yes X No
Estimated completion time: two (2) hours Number of CSE’s: one (1)
Customer application training? Yes X No
Systems/Products affected/System identifying IVK
Name Material No. Serial No.
MAMMOMAT Novation DR 06646900 1002 - 1006,1008 - 1009
1011 - 1016,1018 - 1022
Remark: n.a.
Components affected/to be modified/IVK
Name Material No. Serial No. Component status
affected
Radiation protec-
tion and console 06438894 n.a. n.a.
support
Remark: n.a.
© Siemens AG 2004
Chg. Ref. No.: TDSP-CR-03/04 0012 The reproduction, transmission or use
of this document or its contents is not
Name: St. Gyönyör permitted without express written
authority. Offenders will be liable for
Dept.: CS PS 24 damages. All rights, including rights
created by patent grant or registration
of a utility model _or_ design,_are_
reserved.
Print No.: SPB7-250.896.02.01.02 Doc. Gen. Date: 07.04
Replaces: n.a. Version 2.1; January 14, 2003 Page 1 of 6
2 Update Instructions SP014/04/S
Document Revision Level 0
This document corresponds to the version/revision level effective at the time of system
delivery. Revisions to hardcopy documentation are not automatically distributed.
Please contact your local Siemens office to order current revision levels.
Disclaimer 0
The installation and service of equipment described herein is to be performed by qualified
personnel who are employed by Siemens or one of its affiliates or who are otherwise
authorized by Siemens or one of its affiliates to provide such service.
Assemblers and other persons who are not employed by or otherwise directly affiliated
with or authorized by Siemens or one of its affiliates are directed to contact one of the
local offices of Siemens or one of its affiliates before attempting installation or service pro-
cedures.
Systems/Products Affected 0
Following MAMMOMAT Novation DR Digital Mammography systems, System identifying
IVK No: 066 46 900 are affected:
The range of serial numbers: 1002 - 1006, 1008 - 1009, 1011 - 1016 and 1018 - 1022.
Reason for the Update 0
The analysis of the incoming Installation Reports has shown that at some sites the Radia-
tion shield and console carrier wasn't properly fixed to the floor.
It was observed that neither the corresponding wording within the former Revision (01) of
the Planning Guide, nor the analogical wording in the Revision 04 of the Installation
Instruction - Radiation shield - Print number SPB7-230.031.07.04.02 can be considered
as completely clear. In order to ensure that the installation of this component (06438894)
gets carried out properly, i.e. in accordance with the IEC 60601-2-32, not only the said
documents were revised and actualised, but this safety-related Update Instruction is being
issued, requiring:
1. an immediate crosscheck of fixation of the floor plate of the console carrier,
2. the rectification of fixation according to the revision 02 of the Planning Guide
without delay wherever necessary, and
3. the reporting of this issue through due process.
Prerequisites 0
(Materials für Update)
Suitable dowels / anchor bolts according to data and to the description/ instruction in the
actually applicable and valid Planning Guide (at the time when this instruction is being
issued it is the Document Print number: SPB7-250.891.01.02.02 - Page 3-2. The dowels
have to be procured on site. Application of sanitary silicone - as sealant around the floor
plate - is recommended.
MAMMOMAT Novation DR SPB7-250.896.02 Page 2 of 6 Siemens AG
Rev. 01 07.04 CS PS 24 Medical Solutions
Update Instructions SP014/04/S 3
Special Tools / Documents 0
Suitable dowels / anchor bolts - see in Section Prerequisites (Materials for update).
Sanitary silicone,
Hammer drill,
Planning Guide, Print No: SPB7-250.891.01.02...
Ordering Information 0
No update kit is intended to be supplied with this instruction. Proceed according to infor-
mation in Section Prerequisites (Materials for update) above.
Contents of the Update Kit 0
n.a. (see remark in Section Ordering Information above).
Return of Parts 0
n.a.
Siemens AG SPB7-250.896.02 Page 3 of 6 MAMMOMAT Novation DR
Medical Solutions Rev. 01 07.04 CS PS 24
4 Update Instructions SP014/04/S
Work Steps 0
General information 0
There are two sales Items with two sales material numbers for the "Radiation shield and
control console carrier":
>> 044 94 345,
incorporating the MatNo: 6431774 - Lead glass with lead equivalent of 0.1 mm, and
>> 044 94 352,
incorporating the MatNo: 6551356 - Lead glass with lead equivalent of 0.3 mm.
Both sales items incorporate also the material number 064 38 894, i.e. the "Console car-
rier kit" itself. The console carrier kit (to be assembled at site) consists of different parts,
important for this UI are:
the material number 063 43 508 - Levelling screw, hollow, and
the material number 061 40 391 - Cover plate.
Two (2) of each should have been delivered to the site.
• Check whether the Radiation shield and console carrier has been installed in
accordance with the corresponding description on the Page 3 - 2 of the Planning Guide.
• If yes, report this fact in manner usual for reporting about the Update Instructions, stating
that the UI SP014/04/S has been complied with, (see under Final Work Steps).
• If not, proceed with correct fastening of the Radiation shield and console carrier. Level
the carrier horizontally and vertically by means of the hollow levelling screws in the
mounting plate and by means of the levelling bolt under the other side of the Radiation
shield lead glass, apply the two dowels / anchors and tighten them. Cover the two
openings by cover plates.
• Apply suitable sealant, e.g. sanitary silicone, around the mounting plate.
MAMMOMAT Novation DR SPB7-250.896.02 Page 4 of 6 Siemens AG
Rev. 01 07.04 CS PS 24 Medical Solutions
Update Instructions SP014/04/S 5
• Report the performance in the manner customary for reporting on the Update
Instructions, stating that the UI SP014/04/S has been complied with, (see under Final
Work Steps).
Final Check 0
• When the fixation work on the carrier / support is finished, perform a test exposure.
Through this you can check that the work just performed on the console carrier didn’t
cause any possible damage to the Novation DR system.
Customer Information 0
Inform the Customer about the fixation of the console carrier.
Final Work Steps 0
• Update the system documentation. - not applicable.
• This update doesn’t include an IVK.
• Updates that have already been completed prior to publication of this UI must also be
reported.
• The Update is reported as follows: usually by the authorized personnel using an on-line
application on the Intranet, or - for some regional units - in writing directly to Department
CS PS 1 in the Headquarters in Erlangen.
Changes to Previous Version 0
n.a. - first Version.
Siemens AG SPB7-250.896.02 Page 5 of 6 MAMMOMAT Novation DR
Medical Solutions Rev. 01 07.04 CS PS 24
6 Update Instructions SP014/04/S
Completion Protocol 0
The update instruction with the number SP014/04/S has been completed.
Material number: ...6646900................
Serial number: ................................
Customer: ................................ Functional Location:................................
Customer No.: ................................
Name ( CSE ): ................................ Telephone: ................................
Country: ................................ Location: ................................
Date: ................................ Signature: ................................
Remark: ....................................................................................................
....................................................................................................
NOTE After completing the update, make a copy of this page, fill it out and file
it in the corresponding System Binder/User Handbook.
MAMMOMAT Novation DR SPB7-250.896.02 Page 6 of 6 Siemens AG
Rev. 01 07.04 CS PS 24 Medical Solutions
