SSH-XFC2Crossfire 2 Console

Crossfire™ 2 REF0475100000 DRAFT EN-1 Contents Warnings and Cautions......................................................................3 Product Description/Intended Use.................................................7 Package Contents.................................................................................8 Available Accessories............................................................................8 The Crossfire 2 Console.........................................................................9 The Crossfire 2 Interface......................................................................11 Arthroscopy Mode.............................................................................12 Indications for Arthroscopic Use..........................................................12 Setup and Device Connections............................................................13 Adjusting User and System Settings.....................................................17 Arthroscopic Shaver Controls...............................................................19 RF Ablation Controls...........................................................................25 Dual Controls......................................................................................30 Laparoscopy Mode............................................................................32 Indications for Laparoscopic and General Surgery Use..........................32 Setup and Device Connections............................................................33 Adjusting User and System Settings.....................................................36 Vessel Sealing Controls........................................................................38 Troubleshooting................................................................................44 Error Codes.........................................................................................46 Cleaning and Maintenance.............................................................47 Cleaning.............................................................................................47 Maintenance......................................................................................47 Disposal.............................................................................................48 Technical Specifications...................................................................49 Generator Output...............................................................................50 Electromagnetic Compatibility............................................................55 Symbol Glossary.................................................................................59 EN-3 DRAFT Warnings and Cautions Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meanings and should be carefully reviewed: WarningWarnings indicate risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user. CautionCautions indicate risks to the equipment. Failure to follow cautions may result in product damage. NoteNotes provide special information to clarify instructions or present additional useful information. To avoid potential serious injury to the user and the patient and/or damage to this device, the user must obey the following warnings. The warranty is void if any of these warnings is disregarded. 1. Caution: Federal law (USA) restricts this device to use by, or on order of, a physician. 2. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. Refer any readjustments, modifications, and/or repairs to Stryker Endoscopy or its authorized representatives. 3. Pay close attention to the care and cleaning instructions in this manual. Failure to follow these instructions may result in product damage. 4. Install this device in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices. 5. DO NOT use the Crossfire 2 system on patients with cardiac pacemakers or other electronic device implants. Doing so could lead to electromagnetic interference and possible death. Fire/Explosion Warnings 1. DO NOT use this device in the presence of flammable anaesthetics, other flammable gases or objects, near flammable fluids such as skin prepping agents and tinctures, or oxidizing agents. Observe appropriate fire precautions at all times. 2. DO NOT use this device in oxygen-enriched atmospheres, nitrous oxide (N₂O) atmospheres, or in the presence of other oxidizing agents, to prevent risk of explosion. Ensure that oxygen connections are not leaking. EN-4 DRAFT 3. Electrosurgical components, such as the probe, may remain hot following activation. Keep all electrosurgical equipment away from flammable materials to avoid combustion. 4. To prevent the risk of fire, DO NOT replace console fuses. If it is suspected that fuses are damaged, return console to Stryker for repair. Prior to Surgery 1. The operator of the Crossfire 2 system should be a qualified physician, having complete knowledge of the use of this equipment and awareness of the risks associated with arthroscopic and laparoscopic electrosurgical procedures. 2. The operator of the Crossfire 2 system should be experienced in arthroscopic and electrosurgical practices and techniques. 3. The operator of the Crossfire 2 system should read this manual thoroughly and be familiar with its contents prior to operating the equipment. 4. The operator of the Crossfire 2 system should be sure that the system functions as outlined in this manual prior to a surgical procedure. The Crossfire 2 system was fully tested at the factory before shipment. 5. Crossfire 2 system components are designed to be used together as a system. Use only the appropriate footswitch, handpiece, and disposable attachments described in this manual. 6. Carefully unpack the unit and ensure that all componen…

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775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: [email protected] Project and Product Certification Representative Authorization Letter Reason for Amendment (current / obsolete) Revision History Approved Date From To Initial Release (obsolete) 1.0 1.0 Nov-14-2006 Revised wording (obsolete) 1.0 2.0 Sept–25-2007 Updated company template (current) 2.0 3.0 Jan-31-2012 5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2505 www.stryker.com Endoscopy SCS-F18: Project and Product Certification Representative Authorization Letter Page 2 of 2 Rev 3.0 May 2, 2012 To: SIEMIC, INC. 775 Montague Expressway, Milpitas, CA 95035 USA Dear Sir/Madam, Re: Project and Product Certification Representative Authorization Letter We, Stryker Endoscopy, hereby authorize SIEMIC, INC. to act as a Certification Body for certifying for the following project(s): Crossfire 2 Console, p/n: 0475100000 We affirm that between SIEMIC and Stryker Endoscopy, any difference in understanding, including test plan, measurement methods, applicable standards and relevant procedures and processes have been resolved prior to commencement of testing activities. Sincerely, Client’s signature: Client’s name/title: Steven Maulick, Associate Director of R&D Contact information/address: Stryker Endoscopy, 5900 Optical Ct, San Jose, CA 95138

775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: [email protected] Confidentiality Request Letter Reason for Amendment (current / obsolete) Revision History Approved Date From To Initial Release (obsolete) 1.0 1.0 Nov-14-2006 Adding CFR 2.459 (obsolete) 1.0 2.0 August – 11 - 2008 Updated company template & Added text box (current) 2.0 3.0 Jan-31-2012 5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2505 www.stryker.com Endoscopy SCS-F19: Confidentiality Request Letter Page 2 of 2 Rev 3.0 May 2, 2012 To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD Subject:Permanent Confidentiality Request for FCC ID: SSH-XFC2 We hereby request confidential treatment of information accompanying this application as outlined below: -RFID Block Diagram -System Level Block Diagram -RFID Schematic -System Level Schematic -Operational Description -Antenna Information The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 & 0.459 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Client’s signature : Client’s name / title : Steven Maulick, Associate Director of R&D Contact information / address: Stryker Endoscopy, 5900 Optical Ct, San Jose, CA 95138

SAN JOSE, CA 95138 5900 OPTICAL COURT STRYKER ENDOSCOPY NOTES: 1. INTERPRET DRAWING PER AMERICAN SOCIETY OF MECHANICAL ENGINEERS (ASME) Y14.5M-1994 STANDARD. 2. ALL GRAPHICS AND LINE RULES IN BLACK, EXCEPT WHERE NOTED. 3. PRINT IN COLOR. USE ARTWORK FILE. 4. PRINT IS FOR REFERENCE ONLY. USE .AI FILES FOR ACTUAL PRINTING UNLESS OTHERWISE SPECIFIED DIMENSIONS ARE IN INCHES DECIMALS .XX.01 XXX.005 ANGLES.5 REQUIREMENTS FOR FINISHED PARTS UNLESS OTHERWISE SPECIFIED ALL DIMENSIONS APPLY AFTER COATING ON ALL PLATED PARTS CORNERS MUST BEND SMOOTHLY TOLERANCES FRACTIONAL.......................................................1.64 CORNER BREAK (EXTERNAL)(DEBUR)..... ...............................002 TO 0.20R (OR EQUIVALENT) FILLET RADII (INTERNAL)............ ................................................002 TO 0.20R THREAD CHAMFER (OR CSK).....................................................1 TO 1/2 THREADS DEEP SURFACE INTERSECTIONS..........................................................010 MAX HOLES AND FEATURES TO BE ON THE...................... .010 MAX GENERAL FINISH........................................................................... 63 MAX CONCENTRICITY .006 TIR PERPENDICULARITY .006 IN/IN TOTAL (MAX) PARALLELISM .010 (MAX) ROUNDNESS .006 (MAX) FLATNESS .006 IN/IN (MAX) STRAIGHTNESS .001 IN/IN (MAX) SYMMETRY .020 (MAX) SIZE REV. DWG. NO. TITLE: SHEET1 OF 1 THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF STRYKER ENDOSCOPY, SAN JOSE. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, USED, OR DISCLOSED TO OR FOR THE BENEFIT OF ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER. THIRD ANGLE PROJECTION DRAWN BY: F. TURPO 03/05/12 P13830 ARTWORK; CROSSFIRE 2 REAR CHASSIS SILKSCREEN DATE BD -DO NOT SCALE DRAWING- REVISIONS APPROVEDDATEDESCRIPTIONLTR . i A ECO # 37654 - NEW RELEASE 11/15/10 S/C. BENNETT 12.54" 4.51" B ECO # 41803 - MOVE STICKER BOX AWAY FROM SPEAKER HOLES 02/08/11 S/C. BENNETT C ECO # 51797 - UPDATE SYMBOLS 01/18/12 S/C. BENNETT Stryker European Rep. - RA/QA Manager ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, France Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA RF OUTPUT POWER 400W @ 200Ω OPERATING FREQUENCY 200kHz Made in USA FCC ID: SSH-XFC2 This device complies with 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. NOTE: FCC regulations provide that changes or modifications not expressly approved by Stryker Endoscopy could void authority to operate this equipment. IC: 4919C-XFC2 D ECO # 53258 ADD FCC AND IC ID INFORMATION 03/05/12 S/C. BENNETT 3 NOTES: 1. INTERPRET DRAWING PER AMERICAN SOCIETY OF MECHANICAL ENGINEERS (ASME) Y14.5M-1994 STANDARD. UNLESS OTHERWISE SPECIFIED DIMENSIONS ARE IN INCHES DECIMALS .XX.01 XXX.005 ANGLES.5 REQUIREMENTS FOR FINISHED PARTS UNLESS OTHERWISE SPECIFIED ALL DIMENSIONS APPLY AFTER COATING ON ALL PLATED PARTS CORNERS MUST BEND SMOOTHLY TOLERANCES FRACTIONAL..............1.64 CORNER BREAK (EXTERNAL)(DEBUR)..... .002 TO 0.20R (OR EQUIVALENT) FILLET RADII (INTERNAL)............ .002 TO 0.20R THREAD CHAMFER (OR CSK)........... 1 TO 1/2 THREADS DEEP SURFACE INTERSECTIONS...............010 MAX HOLES AND FEATURES TO BE ON THE ..010 MAX GENERAL FINISH..................... 63 MAX CONCENTRICITY .006 TIR PERPENDICULARITY .006 IN/IN TOTAL (MAX) PARALLELISM .010 (MAX) ROUNDNESS .006 (MAX) FLATNESS .006 IN/IN (MAX) STRAIGHTNESS .001 IN/IN (MAX) SYMMETRY .020 (MAX) THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF STRYKER ENDOSCOPY, SAN JOSE. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, OR DISCLOSED TO OR FOR THE BENEFIT OF ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER. SHEET1 OF 1 P13828 SAN JOSE, CA 95138 5900 OPTICAL COURT STRYKER ENDOSCOPY DRAWN BY: DATE SIZE DWG. NO. REV. TITLE: THIRD ANGLE PROJECTION REVISIONS APPROVEDDATEDESCRIPTIONLTR A ECO# 40684 NEW RELEASE 01/17/11 S/C. BENNETT A 01/17/11 -DO NOT SCALE DRAWING- i F. TURPO SERIAL NUMBER LABEL, CROSSFIRE 2 CONSOLE A 100-240V~50/60 Hz 6-10A 0475100000 2. MATERIAL: .002 BRIGHT SILVER POLYESTER LAMINATED W/.001 IMPRINTABLE POLYESTER (COMPUCAL OR EQUIV.) 3. ADHESIVE: FLEXCON V 23 OR EQUIV. PSA BACK SIDE 4. GRAPHIC: BLACK ON SIVLER 5. TEXT: HELVETICA 6 MANUFACTURING DATE TO BE PRINTED AT TIME OF PRODUCTION. USE FORMAT: YYYY-MM P13828 Rev. A CUT LINE 6 PT 2.00" ±.05 1.00" ±.05 0.10" ±.01 0.125" ±.010 0.125" ±.010 C C YYYY-MM 8 PT 6

Cover Off PCB Board A-Top View PCB Board A-Top View PCB Board B-Top View PCB Board B-Bottom View Antenna View

STRYKER ENDOSCOPY CROSSFIRE™ 2 Model: 0475100000 April 26, 2012 R eport No.: SL12022701-STR-005(FCC,IC)rev 1.0 (This report supersedes: SL12022701-STR-005(FCC,IC) Modifications made to the product : None This Test Report is Issued Under the Authority of: Choon Sian Ooi Compliance Engineer Leslie Bai Director of Certification This test report may be reproduced in full only. Test result presented in this test report is applicable to the representative sample only. Title: RF Test Report of Stryker Endoscopy Model : 0475100000 To FCC 15.225 2010, RSS 210 Issue 8 Serial# SL12022701 STR 005(FCC,IC)rev 1.0 Issue Date April 26, 2012 Page 2 of 66 www.siemic.com Laboratory Introduction ATION SIEMIC, headquartered in the heart of Silicon Valley, with superior facilities in US and Asia, is one of the leading independent testing and certification facilities providing customers with one stop shop services for Compliance Testing and Global Certifications. In addition to testing and certification, SIEMIC provides initial design reviews and compliance management through out a project. Our extensive experience with China, Asia Pacific, North America, European, and international compliance requirements, assures the fastest, most cost effective way to attain regulatory compliance for the global markets. Accreditations for Conformity Assessment Country/Region Accreditation Body Scope USA FCC, A2LA EMC , RF/Wireless , Telecom , SAR Canada IC, A2LA, NIST EMC, RF/Wireless , Telecom , SAR Taiwan BSMI , NCC , NIST EMC, RF, Telecom , Safety Hong Kong OFTA , NIST RF/Wireless ,Telecom Australia NATA, NIST EMC, RF, Telecom , Safety Korea KCC/RRA, NIST EMI, EMS, RF , Telecom, Safety , SAR Japan VCCI, JATE, TELEC, RFT EMI, RF/Wireless, Telecom Mexico NOM, COFETEL, Caniety Safety, EMC , RF/Wireless, Telecom Europe A2LA, NIST EMC, RF, Telecom , Safety, SAR Accreditations for Product Certifications Country Accreditation Body Scope USA FCC TCB, NIST EMC , RF , Telecom Canada IC FCB , NIST EMC , RF , Telecom Singapore iDA, NIST EMC , RF , Telecom EU NB EMC & R&TTE Directive Japan MIC, (RCB 208) RF , Telecom HongKong OFTA (US002) RF , Telecom Title: RF Test Report of Stryker Endoscopy Model : 0475100000 To FCC 15.225 2010, RSS 210 Issue 8 Serial# SL12022701 STR 005(FCC,IC)rev 1.0 Issue Date April 26, 2012 Page 3 of 66 www.siemic.com This page has been left blank intentionally. Title: RF Test Report of Stryker Endoscopy Model : 0475100000 To FCC 15.225 2010, RSS 210 Issue 8 Serial# SL12022701 STR 005(FCC,IC)rev 1.0 Issue Date April 26, 2012 Page 4 of 66 www.siemic.com CONTENTS 1 EXECUTIVE SUMMARY & EUT INFORMATION ............................................................................................................. 6 2 TECHNICAL DETAILS .................................................................................................................................................. 7 3 MODIFICATION ............................................................................................................................................................ 8 4 TEST SUMMARY .......................................................................................................................................................... 9 5 MEASUREMENTS, EXAMINATION AND DERIVED RESULTS ...................................................................................... 10 ANNEX A. TEST INSTRUMENT & METHOD......................................................................................................................... 21 ANNEX B. TEST SETUP PHOTOGRAPHS .......................................................................................................................... 25 ANNEX B. I. EUT INTERNAL PHOTOGRAPHS .................................................................................................................... 26 ANNEX B. II. EUT EXTERNAL PHOTOGRAPHS .................................................................................................................. 27 ANNEX C. SUPPORTING EQUIPMENT DESCRIPTION ........................................................................................................ 28 ANNEX D. EUT OPERATING CONDITIONS ........................................................................................................................ 31 ANNEX E. USER MANUAL, BLOCK & CIRCUIT DIAGRAM .................................................................................................. 32 ANNEX E SIEMIC ACCREDITATION ................................................................................................................................... 33 ANNEX F. TEST PLOTS....................................................................................................................................................... 61 Title: RF Test Report of Stryker Endoscopy Model : 0475100000 To FCC 15.225 2010, RSS 210 Issue 8 Serial# SL12022701 STR 005(FCC,IC)rev 1.0 Issue Date April 26, 2012 Page 5 of 66 www.siemic.com This page has been left blank intentionally. Title: RF Test Report of Stryker Endoscopy Model : 0475100000 To FCC 15.225 2010, RSS 210 Issue 8 Serial# SL12022701 STR 005(FCC,IC)rev 1.0 Issue Date April 26, 2012 Page 6 of 66 www.siemic.com 1 Executive Summary & EUT information The purpose of this test programmed was to demonstrate compliance of the Stryker Endoscopy Model: 0475100000 against the current Stipulated Standards for FCC or IC.The equipment under test radio operating frequency is 13.56 MHz.The test has demonstrated that this unit complies with stipulated standards. EUT Information EUT Description : The Crossfire™ 2 console Integrated Resection and Sealing Systems is a combination powered shaver system/ electrosurgical generator that powers arthroscopic shaver handpieces, RF surgical probes, and vessel sealing handpieces for use in a variety of arthroscopic, orthopedic, and general laparoscopic surgeries. The Crossfire™ 2 console consisted of a chassis meant for table top…

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Radiated Emission (>30MHz) – Front View Radiated Emission (>30MHz) – Rear View Radiated Emission (<30MHz) – Front View Radiated Emission (<30MHz) – Rear View AC Line Conducted Emission Set up