Siemens Mammomat 1000 Update Instructions

Mammomat 1000

SP

Update Instructions

Title:

Reason for Update: Performance

Urgency: Immediate Within 6 months
Update material required? Yes No
Materials free of charge? Yes No
Return of parts? Yes (See page 3) No
Estimated completion time: 1 h Number of CSE’s: one (1)
Customer application training? Yes No

Systems/Products affected/System identifying IVK

Name Material No. Serial No.

Exchange of Diaphragm

X
X
X

SP017/02/P

X

X

X

Mammomat 1000 61 34 709 8601 - 9131

Remark: Affected units delivered to different countries within the serial number inter­val, see table on page 2.

Components affected/to be modified

Name Material No. Serial No. Component status

affected

n.a. n.a. n.a. n.a.

Remark:

© Siemens AG 2002

Chg. Ref. No.: RBN S2050785
Name: Engman/Sundkvist/Lindström
Dept.: CS PS 24/SPS

Print No.: SPB7-230.896.11.01.02 Doc. Gen. Date: 10.02

Replaces: n.a. 66 31 803 Page 1 of 6

The reproduction, transmission or use
of this document or its contents is not
permitted without express written
authority. Offenders will be liable for
damages. All rights, including rights
created by patent grant or registration
of a utility model _or_ design,_are_
reserved.

2 Update Instructions SP017/02/P

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 pro­cedures.

Systems/Products Affected 0

Mammomat 1000 (mat. no. 61 34 709) within serial number interval 8601 - 9131. See
table below for detailed designation of affected units.

Country Number of

Update Kits

Austria 1 9054

France 1 8636

Germany 6 8680

India 1 8611

Italy 1 8725

Japan 2 9033

Pakistan 1 9108

Philippines 1 9038

Portugal 1 9053

South Korea 1 9037

Spain 3 8601

The Netherlands 1 8699

Turkey 4 8640

Uruguay 1 9008

Tab. 1 Designation of affected units

Serial No.

Mammomat 1000

9014

9059

9060

9083

9105

9051

8639

8641

9056

9057

9131

Mammomat 1000 SPB7-230.896.11 Page 2 of 6 Siemens AG
Rev. 01 10.02 CS PS 24/SPS Medical Solutions

Update Instructions SP017/02/P 3

Reason for the Update 0

A number of faulty diaphragms have been delivered together with the Mammomat 1000 in
the mentioned serial number interval.

These diaphragms can be mounted in the wrong position giving a white stripe along the
chest wall.

These faulty diaphragms must be exchanged to the ones delivered in the Update Kit.

18 x 24 CM

SID 65 CM

MODEL No.:

SERIAL/LOT No.:

This product complies with DHHS regulations
21 CFR Subchapter J, applicable at date of
manufacture:
Manufactured:

Siemens Aktiengesellschaft

Wittelsbacherplatz 2. D-8 Munchen 2

Germany

R 8 mm x 2

R 4 mm x 2

18 x 24 CM

SID 65 CM

MODEL No.:

SERIAL/LOT No.:

This product complies with DHHS regulations
21 CFR Subchapter J, applicable at date of
manufacture:
Manufactured:

Siemens Aktiengesellschaft

Wittelsbacherplatz 2. D-8 Munchen 2

Germany

R 8 mm x 4

MAM00950

Fig. 1 Difference between right and faulty diaphragm

Prerequisites 0

No special prerequisites.

Special Tools / Documents 0

No special tools needed.

Ordering Information 0

The following update kit has to be ordered from CSML (SAP Distribution Chan nel, factory

2050):
Update Kit Diaphragm M1000 66 33 148 X041E

Siemens AG SPB7-230.896.11 Page 3 of 6 Mammomat 1000
Medical Solutions Rev. 01 10.02 CS PS 24/SPS

4 Update Instructions SP017/02/P

Contents of the Update Kit 0

The Update Kit 66 33 148 contains the following parts:

Pos. Quan. Material No. Name

1 1 64 83 692 Diaphragm, 18x24, deep
2 1 64 83 700 Diaphragm, Magnification, deep
3 1 66 31 803 Update Instructions, UI SP017/02/P

Tab. 2 Contents of the Update Kit

Return of Parts 0

There is no requirement on return of faulty diaphragms back to CSML for scrapping. The
diaphragms can be scrapped by the CSE at the Regional Unit.

Work Steps 0

• Exchange the faulty diaphragms at site with the ones delivered with the Update kit.

• Scrap the faulty diaphragms.

Customer Information 0

n.a.

Final Work Steps 0

• Update the system documentation.

Update the revision level, the operating instructions and the technical documentation.
Fill out, and if needed, make a copy of the attached "Completion Protocol/ Update
Completion Form" and file it in the corresponding System Binder/User Handbook.

• This update includes an IVK.

- Changes in the IVK structure must be reported to the management system to correct
the installed volume.

• Updates that have already been completed prior to publication of this UI must also be

reported.

• The update is reported as follows:

- The modification reply cards (Type 606) previously distributed with the publication of
updates no longer apply.

- The modification reply report has to be prepared by authorized personnel using an
application on the Intranet.

Mammomat 1000 SPB7-230.896.11 Page 4 of 6 Siemens AG
Rev. 01 10.02 CS PS 24/SPS Medical Solutions

Update Instructions SP017/02/P 5

Completion Protocol/Update Completion Form 0

The update with the number SP017/02/P has been completed.

Material Number: 61 34 709

Serial Number: ................................

Customer: ................................ Site: ................................

Customer No.: ................................

Name ( CSE ): ................................ Telephone: ................................

Country: ................................ Location: ................................

Date: ................................ Signature: ................................

Remark: ....................................................................................................

....................................................................................................

NOTE

Siemens AG SPB7-230.896.11 Page 5 of 6 Mammomat 1000
Medical Solutions Rev. 01 10.02 CS PS 24/SPS

After completing the update, make a copy of this page, fill it out and file
it in the corresponding System Binder/User Handbook

.

6 Update Instructions SP017/02/P

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Mammomat 1000 SPB7-230.896.11 Page 6 of 6 Siemens AG
Rev. 01 10.02 CS PS 24/SPS Medical Solutions