Stryker SwitchPoint III User manual

UNITED STATES PATENT AND TRADEMARK OFFICE
________________________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
STRYKER CORPORATION,
Petitioner
v.
KARL STORZ ENDOSCOPY-AMERICA, INC.,
Patent Owner
Patent No. 8,069,420
Issue Date: November 29, 2011
Title: SYSTEM FOR CONTROLLING THE COMMUNICATION OF
MEDICAL IMAGING DATA
IPR Number 2015-00677
DECLARATION OF STEVEN MAULICK
1
Stryker Exhibit 1009
Stryker Corp. v. KSEA, Inc.
IPR2015-00677

Petition for Inter Partes Review of U.S. Patent No. 8,069,420 IPR2015-00677
1
I, Steven Maulick, hereby declare and state as follows:
1. I am the Associate Director of Engineering Services at Stryker
Endoscopy, located at 5900 Optical Court, San Jose, California 95138.
2. I submit this declaration in support of Stryker’s Petition for Inter
Partes Review of U.S. Patent No. 8,069,420. I have been asked to provide
information regarding the SwitchPoint III Operations and Maintenance Manual
(“the SP3 Manual”) attached hereto as Exhibit A and the SDC Pro 2 Digital
Capture Operating and Maintenance Manual (“the SDC Pro 2 Manual”) attached
hereto as Exhibit D. The SP3 Manual describes the operation and functionality of
Stryker’s SwitchPoint III product, which is a video router system for use in
operating rooms. The SDC Pro 2 Manual describes the operation and functionality
of Stryker’s SDC Pro 2 product, which is a digital documentation system for use in
operating rooms. I am familiar with the facts of this matter, and this declaration is
based on my personal knowledge and information.
3. I have been employed at Stryker Endoscopy (a division of Stryker
Corporation) since 2000, and have been the Associate Director or Manager of
Engineering Services here since 2003. My responsibilities as the Associate
Director of Engineering Services include Document Control, Technical
Publications and Test Engineering.
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Petition for Inter Partes Review of U.S. Patent No. 8,069,420 IPR2015-00677
2
4. Prior to my position in Engineering Services, I was employed as
Manufacturing Process Engineer. My responsibilities included product transfer to
production, electronic troubleshooting and repair, and post-launch cost
improvements.
5. As the Associate Director of Engineering Services at Stryker
Endoscopy, I have personal knowledge regarding the records, documents, and
manuals relating to the SwitchPoint III products made and kept by Stryker
Endoscopy.
6. For as long as I have worked here, Stryker Endoscopy has regularly
maintained, in the course of its ordinary business, records of the released versions
of the manuals that accompany its SwitchPoint products when those products are
shipped to customers. Stryker Endoscopy has also maintained records of
“Engineering Change Notices,” which are documents that establish the process for
requesting and controlling changes to Stryker Endoscopy documents.
7. Attached hereto as Exhibit A is Revision D of the SP3 Manual, which
bears a date of October 21, 2002. I located this document in Stryker’s records as
follows: First, I accessed Stryker Endoscopy’s legacy document storage system
(called Sarnoff), which is used to store company files and records that pre-date
Stryker’s current electronic document management system. Next, I looked in a
sub-folder labeled “Obsolete Docs.” It is my understanding that the Document
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Petition for Inter Partes Review of U.S. Patent No. 8,069,420 IPR2015-00677
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Control Group at Stryker Endoscopy stores only previous released versions of
product manuals in this folder. Within the folder, I located the version of the SP3
Manual (Rev. D, dated October 21, 2002) that is attached hereto as Exhibit A.
Accordingly, it is my belief that the accompanying SP3 Manual was indeed a
released version that was shipped to customers as of October 2002.
8. I have also confirmed that the SP3 Manual attached hereto as Exhibit
A is the version that was released in October 2002 as follows. In addition to its
electronic records, Stryker Endoscopy maintains off-site storage of physical copies
of its legacy documents. For example, Stryker maintains hard copies of its legacy
ECN documents and its legacy released product manuals.
9. Attached hereto as Exhibit B is a true and correct copy of Engineering
Change Notice #619 (“ECN #619”), dated September 24, 2002. As shown in the
“Description of change” field, ECN #619 is directed toward “Modify[ing] the
Switchpoint III Operations and Maintenance manual as indicated in the attached
document.” (Ex. B.) In the “Document File Name” field appears the text “0100-
000-595; User’s Manual, Switchpoint III.” (Id.) The “Revision Level” fields
indicate that the revision level of the manual was changed from level C to level D.
(Id.) This revision is deemed “Permanent” in the “Change Type” field. (Id.) In
the “Time to Implement Change” field, the “Immediate Change” option is selected.
(Id.)
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Petition for Inter Partes Review of U.S. Patent No. 8,069,420 IPR2015-00677
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10. Stryker Endoscopy maintains a paper record of ECN #619, along with
the relevant attachments to that ECN, in its off-site storage facility. More
specifically, because ECN #619 authorized the release of Revision D of the SP3
Manual, Stryker maintains a copy of both ECN #619, itself, and a copy of the SP3
Manual that ECN #619 officially released. These documents are stored together,
per Stryker’s usual recordkeeping practices.
11. On February 10, 2015, I contacted the off-site storage facility and
requested copies of ECN #619 and its attachments. These documents were
provided on February 11, 2015. As expected, and in keeping with Stryker’s
regular practice, ECN #619 was supplied to me along with Revision D of the SP3
Manual, which ECN #619 officially released for public dissemination. Attached
hereto as Exhibit C is a true and correct copy of the paper record of ECN #619 and
the accompanying SP3 Manual that I received from Stryker’s off-site storage
facility on February 11, 2015.
12. I have reviewed the version of the SP3 Manual provided to me by the
off-site storage facility in conjunction with ECN #619. I affirm that the SP3
Manual attached hereto as Exhibit A is a true and correct copy of that document. I
also affirm that the SP3 Manual I located in Stryker’s electronic files, as described
above in ¶ 7, is a true and correct copy of the SP3 Manual provided to me by the
off-site storage facility.
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Petition for Inter Partes Review of U.S. Patent No. 8,069,420 IPR2015-00677
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13. Attached hereto as Exhibit D is Revision A of the SDC Pro 2 Manual,
which bears a copyright date of 2002 and is referred to as Document No. 1000-
400-612 in Stryker’s records, and a cover sheet referencing ECN # 21816, which
released Revision A of the SDC Pro 2 Manual as of January 23, 2002. I located
this document in Stryker’s records by accessing Stryker’s electronic document
management system, and searching for the released version of Document No.
1000-400-612, which is the SDC Pro 2 Manual. It is my understanding that the
Document Control Group at Stryker Endoscopy stores only released versions of
product manuals in this manner. Accordingly, it is my belief that the
accompanying SDC Pro 2 Manual was indeed a released version that was shipped
to customers as of January 2002.
14. I declare under penalty of perjury that to the best of my knowledge,
information, and belief, the foregoing statements are true and correct.
Dated: February 17, 2015
______________________________
Steven Maulick
6

EXHIBIT A
7

OPERATIONS AND MAINTENANCE MANUAL
™
ThisOperations andMaintenanceManualcontains
confidentialinformationthat shall not bedisclosed
or duplicated for any reason other than to use and
maintain a SwitchPoint III installation. This
restrictiondoes notlimitthe rightto useinformation
contained in this manual if it is obtained from
anothersource without restriction.The information
subject to this restriction is contained in all pages
of this manual.
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SwitchPoint III
Operations and Maintenance Manual
Part # 0100-000-595 Rev D
Dated: October 21, 2002
© Copyright 2002 Stryker Communications Corporation
Interactive Campus Telemedical System™, ICTS™, Video Network Hub™, Electronic Presentation Podium™,
Stryker TeleHealth Network™, and SwitchPoint™ III are trademarks of Stryker Communications Corporation.
Endosuite® OR is a registered trademark of Stryker Endoscopy. All Rights Reserved.
Stryker Communications
1100 North Magnolia Avenue, Suite A
El Cajon, CA 92020
Telephone: [phone]
Toll Free: 877-789-8106
Fax: [phone]
E-mail: [email protected]
www.strykercom.com
Video# [phone] (calls to 1.472 Mbps)
System Install Date: __________________________
Software Version Installed: ____________________
Note: The serial number for the Switch-
Point III is located on an ID plate
on the front panel of the unit.
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Stryker Communications Corporation © Copyright 2002 - All Rights Reserved 877-789-8106
INTRO-3 SWITCHPOINT III - OPERATIONS AND MAINTENANCE MANUAL
WARNINGS AND CAUTIONS
TO AVOID POTENTIAL SERIOUS INJURY TO THE
USER AND THE PATIENT AND/OR DAMAGE TO THIS
DEVICE, THE USER MUST:
1. Carefully unpack the unit and check if any damage
occurred during shipment. If damage is detected,
please see Damage Claims in the Appendix.
2. Read this operating manual thoroughly, and be fa-
miliar with its contents prior to using this equipment.
3. Be a qualified physician, having complete knowl-
edge of the use of this equipment.
4. Test this equipment prior to a surgical procedure.
This product was fully tested at the factory before
shipment.
5. Avoid removing covers on the product to avoid elec-
tric shock.
6. Attempt no internal repairs or adjustments unless
specifically instructed to do so in this operating
manual.
7. Pay close attention to the care, cleaning, steriliza-
tion, and disinfection instructions in this manual. A
deviation may cause damage. DO NOT STERIL-
IZE OR DISINFECT THE CONTROL UNIT OR THE
TOUCHPANEL DISPLAY.
8. Disconnect the unit from the electric outlet before
inspecting system components.
9. Read the entire instruction manual before assem-
bling or connecting the unit.
The warranty on this product is void if any of these
warnings are disregarded.
Stryker Communications accepts full responsibility
for the effects on safety, reliability, and performance of
the equipment only if:
•Readjustments, modifications, and/or repairs are
carried out by persons authorized by Stryker Com-
munications and
•The electrical installation of the relevant operating
room complies with the applicable IEC, CEC, and
NEC requirements.
WARNING: Federal law (United States of America)
restricts this device to use by, or on
the order of a physician.
Please read this manual and follow its instructions
carefully. The words WARNING, CAUTION, and NOTE
carry special meanings and should be carefully reviewed:
WARNING: The personal safety of the patient may
be involved. Disregarding this informa-
tion could result in injury to the patient.
CAUTION: Special service procedures or precau-
tions must be followed to avoid dam-
aging the instrument.
NOTE: Special information to make mainte-
nance easier or important information
more clear.
Denotes Class 1 and TYPE B EQUIPMENT.
Class 1 Equipment; Equipment in
which the protection against electric
shock does not rely on Basic insula-
tion only, but includes an additional
safety precaution in such a way that
means are provided for the connection
of Accessible Conductive Parts to Pro-
tective (Earth) Conductor in the fixed
wiring of the installation in such a way
that Accessible Conductive Parts can-
not become Live in the event of a fail-
ure of the Basic Insulation.
Type B Equipment, Type B Equipment
is suitable for intentional external and
internal application to the patient ex-
cluding Direct Cardiac Application.
An exclamation point within a triangle
is intended to alert the user to the pres-
ence of important operating and main-
tenance (service) instructions in the
literature accompanying the product.
A lightning bolt within a triangle is in-
tended to warn of the presence of haz-
ardous voltages. Refer all service to
authorized personnel.
Denotes Compliance to CSA Std. C22.2
No. 601.1-M90 and UL 2601-1. 2nd Edi-
tion
Denotes Compliance with CE Std. IEC
601-1
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