CVOR20S21ASmartTools Pod

SmartKnee Surgical Technique 1 of 58 SmartTools Knee User Guide & Surgical Technique Rev A draft SmartKnee Surgical Technique 2 of 58 Table of Contents 1. Overview ......................................................................................................................................................................... 4 1.1 Indication for use .................................................................................................................................................... 4 1.2 System Overview ..................................................................................................................................................... 4 1.3 Implant indications ................................................................................................................................................. 5 1.4 Contraindications .................................................................................................................................................... 6 1.5 Complications .......................................................................................................................................................... 6 2. Surgery Planning .....................................................................................................................Erreur ! Signet non défini. 3. Pre-Operative Guide ....................................................................................................................................................... 7 3.1 Computer Setup ...................................................................................................................................................... 7 3.2 Surgical preferences and Application Launch ......................................................................................................... 8 3.3 Pods: Power-up and Calibration ........................................................................................................................... 11 3.4 Instrumentation assembly .................................................................................................................................... 12 3.4.1 Instrumentation Assembly for Tibia First ...................................................................................................... 13 3.4.2 Instrumentation Assembly for Femur First ................................................................................................... 14 4. Intra-Operative Guide ................................................................................................................................................... 16 4.1 Distal Femur Cut .................................................................................................................................................... 16 4.1.1 Femoral Landmarks ....................................................................................................................................... 16 4.1.2 Femoral Cut Guide Alignment ....................................................................................................................... 18 4.1.3 Femoral Validation ........................................................................................................................................ 21 4.2 Proximal Tibial Cut ................................................................................................................................................ 23 4.2.1 Tibial Landmarks ........................................................................................................................................... 23 4.2.2 Tibial Cut Guide Alignment ........................................................................................................................... 27 4.2.3 Tibial Validation............................................................................................................................................. 28 5. Post-Operative Guide .................................................................................................................................................... 30 5.1 How to clean and disinfect the System Controller? .............................................................................................. 30 5.2 How to safely dispose Pod’s batteries? ................................................................................................................ 30 5.3 How to retrieve surgical procedures archives? .................................................................................................... 30 5.4 How to record snapshots during a surgical procedure? ....................................................................................... 31 SmartKnee Surgical Technique 3 of 58 5.5 How to shut down the System Controller? ........................................................................................................... 31 6. Appendices .................................................................................................................................................................... 32 6.1 Material information, cleaning and sterilization .................................................................................................. 32 6.1.1 Instruments Sterilization / Cleaning methods .............................................................................................. 33 6.1.2 Sterilization Parameters ................................................................................................................................ 33 6.1.3 Master Instrumentation kit ........................................................................................................................... 33 6.1.4 Implant specific instrumentation .................................................................................................................. 40 6.1.5 Disposables .................................…

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Zimmer CAS 20-8011-000-01 Internal Photos Top View Bottom View Right Side View Left Side View FCC ID: CVOR20S21A IC: 10254A-R20S21A MODEL: 20-8011-000-01

Zimmer CAS 20-8011-000-01 Internal Photos Top View Bottom View Right Side View Left Side View FCC ID: CVOR20S21A IC: 10254A-R20S21A MODEL: 20-8011-000-01 Zimmer CAS 20-8011-000-01 (02) (03) Label Four devices are always packaged together in a box as shown in the picture below. The packaging is sealed and sterilized. The product is used for orthopaedic surgeries. Because the content must be kept sterile, it can only be opened during a surgery, inside the sterile field of the operating room. The devices are disposable, so they are only used once. Because of these reasons, the necessary markings are located on the outer box, where the medical personnel can access it before using the product. Devices inside the packaging

Zimmer CAS 20-8011-000-01 Internal Photos Main Board Zimmer CAS 20-8011-000-01 Internal Photos Radio Board Zimmer CAS 20-8011-000-01 Internal Photos Flexible Board User Interface Membrane Zimmer CAS 20-8011-000-01 Internal Photos Unfolded boards assembly Boards inside enclosure

This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Emissions Report for Zimmer CAS on the Cut Guide POD and Reference POD Page 1 of 77 EMISSIONS TEST REPORT Report Number: 100652281BOX-001 Project Number: G100652281 Report Issue Date: 02/29/2012 Product Designation: Cut Guide POD and Reference POD Standards: CFR47 FCC Part 15 Subpart C 15.247:2012 CFR47 FCC Part 15 Subpart B:2012 IC RSS-210 Issue 8 December 2010 Annex 8 IC RSS-Gen Issue 3 December 2010 IC ICES-003 Issue 4 February 2004 IC RSS-102 Issue 4 March 2010 Tested by: Client: Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, MA 01719 Zimmer CAS 75 rue Queen Suite 3300 Montréal QC H3C 2N6 Report prepared by Reviewer Report reviewed by Vathana F. Ven/Senior Project Engineer Nicholas Abbondante/Staff Engineer Intertek Report Number: 100652281BOX-001 Issued: 02/29/2012 Emissions Report for Zimmer CAS on the Cut Guide POD and Reference POD Page 2 of 77 1 Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 4.0. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product tested complies with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. 2 Test Summary Section Test full name Result 3 Client Information 4 Description of Equipment Under Test 5 System Setup and Method 6 RF Output Power, Duty Cycle, and Human RF Exposure (CFR47 FCC Part 15 Subpart C 15.247(b)(3), KDB 447498, IC RSS-210 A8.4(4), IC RSS-102 Issue 4 March 2010) Pass 7 6 dB Bandwidth (CFR47 FCC Part 15 Subpart C 15.247(a)(2), IC RSS-210 A8.2(a), IC RSS-Gen Section 4.6.2, KDB 558074v01 01/18/2012 Section 5.1) Pass 8 Peak Power Spectral Density (FCC 15:2011 Subpart C Section 15.247 (e), RSS-210 Issue 8 December 2010, A8.2 (b), KDB 558074v01 01/18/2012 Section 5.3) Pass 9 Band Edge Compliance (FCC 15:2011 Subpart C Section 15.247 (d), RSS-210 Issue 8 December 2010, A8.5, KDB KDB 558074v01 01/18/2012 Section 5.4.2.2.4) Pass 10 Transmitter Radiated Spurious Emissions (CFR47 FCC Part 15 Subpart C 15.247(d), IC RSS-210 A8.5, KDB 558074v01 01/18/2012 Section 5.4) Pass 11 Receiver Radiated Spurious Emissions (CFR47 FCC Part 15 Subpart B 15.109, IC RSS-Gen Sections 4.10 & 6.0) Pass 12 AC Line Conducted Emissions (CFR47 FCC Part 15 Subpart B 15.207, IC RSS-Gen Section 7.2.4) Not Required* 13 Revision History * - The EUT is battery powered and does not have facility to connect to the AC mains, directly or indirectly. Intertek Report Number: 100652281BOX-001 Issued: 02/29/2012 Emissions Report for Zimmer CAS on the Cut Guide POD and Reference POD Page 3 of 77 3 Client Information This EUT was tested at the request of: Company: Zimmer CAS 75 rue Queen Montréal QC H3C 2N6 Contact: Mr. Mathieu Chevrier Telephone: (514) 861-4074 Fax: (514) 866-2197 Email: [email protected] 4 Description of Equipment Under Test Equipment Under Test Description Manufacturer Model Number Serial Number POD Cutter Guide Zimmer CAS 20-8011-000-02 Z204004 POD Reference Zimmer CAS 20-8011-000-01 Z204001 Receive Date: 02/02/2012 Received Condition: Good Type: Prototype Description of Equipment Under Test (provided by client) Medical devices (called pods) used on orthopaedic surgical instruments. The pods are disposable and will be delivered in sterile packaging. Will only be used in operating rooms by trained personnel. Battery operation only (non-rechargeable, non-replaceable). Power source is a Lithium-manganese primary battery, CR-1/3N size. Plastic enclosure. No external connections or cables. Three versions of the pods: - 20-8011-000-01 Pod Reference - 20-8011-000-02 Pod Cut Guide TRFL - 20-8011-000-03 Pod Cut Guide TLFR The two cut guide versions are considered identical for certification purposes. Wireless communication to a host via an internal chip antenna. With respect to IEC 60601-1, the pods are considered: - Portable ME equipment - Applied parts - Programmable electrical medical system (PEMS) Equipment Under Test Power Configuration Rated Voltage Rated Current Rated Frequency Number of Phases 3 VDC (Lithium Battery) N/A N/A N/A Operating modes of the EUT: No. Descriptions of EUT Exercising 1 The device was in transmit mode 2 The device was also tested in receive mode Intertek Report Number: 100652281BOX-001 Issued: 02/29/2012 Emissions Report for Zimmer CAS on the Cut Guide POD and Reference POD Page 4 of 77 5 System Setup and Method Cables ID Description Length (m) Shielding Ferrites Termination 1 RJ45 13 None None Laptop 1 USB 1 Foil None Prog 1 USB 1 Foil None Laptop Support Equipment Description Manufacturer Model Number Serial Number Laptop Dell Latitude 2120 27528210001 5.1 Method: Configuration as required by ANS…

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Intertek Report Number: 100652281BOX-001 Issued: 02/29/2012 Emissions Report for Zimmer CAS on the Cut Guide POD and Reference POD Page 68 of 77 11.4 Setup Photographs: Intertek Report Number: 100652281BOX-001 Issued: 02/29/2012 Emissions Report for Zimmer CAS on the Cut Guide POD and Reference POD Page 69 of 77