ROSA Knee User Manual & Surgical Technique V1.2 May 2022

Table of Contents

1. General Information...1 1.1 Conventions... 1 1.2 ROSA Knee System Description... 1 1.3 Contact... 2 1.4 Training... 2 1.5 Intended Use... 2 1.6 Indications for Use... 2 1.7 Contraindications... 3 1.8 Complications... 3 1.9 Restrictions for Use... 3 1.10 Patents... 3 2. About This Manual...4 2.1 Safety... 4 2.1.1 Warnings, Cautions, and Remarks... 4 3. Description...8 3.1 Overview... 8 3.2 Operating Principle... 9 3.2.1 Case Information... 9 3.2.2 Pre-operative Planning... 9 3.2.3 OR Setup... 9 3.2.4 Robotic Unit Registration... 10 3.2.5 Bony Landmarks & Navigation... 11 3.2.6 Planning... 11 3.2.7 Surgery... 11 3.3 System Description... 11 3.3.1 Robotic Unit... 11 3.3.1.1 Robotic Arm... 13 3.3.1.2 Touchscreen... 14 3.3.1.3 Immobilization System... 14 3.3.1.4 Vigilance Device (Foot Pedal)... 14 3.3.2 Optical Unit... 15 3.3.3 Instrumentation... 16 3.3.3.1 ROSA Arm Instrument Interface... 17 3.3.3.2 ROSA Arm Reference Frame... 17 3.3.3.3 ROSA Base Reference Frame... 18 3.3.3.4 ROSA TKA Cut Guide... 18 3.3.3.5 ROSA Registration Pointer... 18 3.3.3.6 Universal Validation Tool Body... 18 3.3.3.7 Distal & Posterior Condyles Digitizer... 18 3.3.3.8 Patient References... 19 3.3.3.8.1 Femoral Reference Frame... 19 3.3.3.8.2 ROSA Tibia Reference A/B... 19 3.3.3.8.3 Offset 2 Pins Reference Tibia... 20

3.4 Instrumentation Assembly... 21 3.4.1 ROSA Arm Instrument Interface on the Robotic Arm... 21 3.4.2 ROSA Arm Reference Frame on the Robotic Arm... 22 3.4.3 ROSA Base Reference Frame on the Robotic Unit... 22 3.4.4 ROSA TKA Cut Guide on the Robotic Arm... 22 3.4.5 Universal Validation Tool Body and Distal & Posterior Condyles Digitizer Validation... 23 3.5 Disposables... 23 3.5.1 Reflective Trackers (NavitrackER®) Installation... 23 3.5.2 Pins... 24 3.5.3 Drapes... 24 4. Installation...25 4.1 Warnings and Cautions About Robotic Unit Installation... 25 4.2 Device Start Up... 26 4.3 Camera Errors... 26 4.3.1 Camera Temperature is Too Low/High... 26 4.3.2 Camera was Bumped... 26 4.4 Emergency Procedure... 27 4.5 Reverting to Standard Instrumentation... 27 4.6 Case Management Application... 28 4.6.1 Case Management Application-Interface Overview... 28 4.6.2 Starting a Case... 28 5. Intra-operative Guide/Surgery...29 5.1 Welcome Screen... 29 5.2 ROSA Knee Software-User Interface Overview... 29 5.2.1 Top Task Bar... 30 5.2.1.1 Panel Buttons... 30 5.2.1.2 Case Information... 30 5.2.2 Bottom Task Bar... 31 5.2.2.1 Menu... 31 5.2.2.2 Camera... 32 5.2.2.3 Snapshot... 32 5.2.2.4 HKA... 32 5.3 Robotic Modes... 33 5.4 Robotic Positions... 33 5.5 Software Audible Notifications... 34 5.6 Software Visual Notifications... 35 5.7 ROSA Knee Software-Surgeon Panel... 35 5.7.1 Femoral Rotation Axis Display... 36 5.7.2 Knee State Evaluation... 36 5.7.3 Femoral Rotation Tool... 36 5.7.4 Flexion Angles for Stress Test... 36

6. ROSA Knee Software-SETUP Panel...37 6.1 OR Setup... 37 6.2 Calibration of Sensor... 37 6.3 Draping... 38 6.4 Touchscreen Monitor Draping... 39 6.5 ROSA Positioning... 39 6.6 Camera Positioning... 40 6.7 ROSA Registration... 41 6.8 Bone References... 41 6.8.1 Patient Femoral Reference... 42 6.8.2 Patient Tibial Reference... 42 6.8.2.1 ROSA Tibia Reference A/B... 42 6.8.2.2 Offset 2 Pins Reference Tibia... 43 7. ROSA Knee Software-Femur Panel...44 7.1 Femoral Head Center... 44 7.2 Femoral Canal Entry... 45 7.3 Posterior Condyles... 45 7.4 Anterior and Posterior Trochlear Groove... 45 7.5 Medial and Lateral Epicondyles... 45 7.6 Medial and Lateral Distal Condyles... 46 7.7 Anterior Cortex... 46 7.8 Femur Panel-Error Notifications... 46 8. ROSA Knee Software-Tibia Panel... 47 8.1 Malleoli... 47 8.2 Medial Third Tubercle... 47 8.3 Tibial Canal Entry... 47 8.4 PCL Insertion Point... 48 8.5 Medial and Lateral Plateau Resection References... 48 8.6 Tibia Panel-Error Notifications... 48 9. ROSA Knee Software-Evaluation Panel (Optional)...49 10. ROSA Knee Software-Planning Panel... 51 10.1 Planning Panel Overview... 51 10.1.1 Implant Selection... 51 10.1.2 Implant Manipulator... 52 10.1.3 Frontal View... 53 10.1.4 Lateral View... 53 10.1.5 Tibia Axial View... 54 10.2 Viewing Options... 54 10.3 Balance Tool... 55 10.4 Femoral and Tibial Components Planning... 56 10.5 Planning Panel-Error Notifications... 57

11. ROSA Knee Software-Resections Drawer...58 11.1 Resections Drawer Overview... 58 11.2 ROSA TKA Cut Guide Installation and Checkpoint... 60 11.3 Femoral Distal Resection... 60 11.4 Tibial Proximal Resection... 61 11.5 Femoral Rotation (Optional)... 63 11.6 Femoral 4-in-1 Resection... 64 11.7 Implant Confirmation Window... 66 11.8 Resections Drawer-Error Notifications... 66 11.9 Final Knee Evaluation (optional)... 66 12. Robotic Errors...67 13. Post-operative Guide/Maintenance...69 13.1 Retrieval of Post-Surgical Log File... 69 13.1.1 Surgeon Report... 69 13.1.2 Investigation Logs... 69 13.2 Shutdown... 70 13.3 Cleaning, Disinfection, and Sterilization... 70 13.3.1 Cleaning the Robotic and Optical Units... 70 13.3.2 Cleaning the Optical Camera... 71 13.3.3 Instruments Reprocessing (Cleaning and Sterilization Methods)... 71 13.3.3.1 Sterilization Parameters... 72 13.3.3.2 ROSA Knee System Instrument Kit... 72 13.3.3.3 ROSA Knee System Instrument Lifetime Expectancy... 74 13.4 Storage and Transport... 75 13.4.1 Storage and Protection... 75 13.4.1.1 Device Storage and Protection... 75 13.4.1.2 Instruments Storage and Protection... 75 13.4.1.3 Care of Cables and Connectors... 75 13.4.2 Device Transport... 76 13.5 Maintenance Operations... 76 13.5.1 Installation... 76 13.5.2 Daily Checks... 76 13.5.3 Periodic Maintenance... 77 13.6 Troubleshooting... 78 13.7 Safe Disposal... 81 14. Product Security Customer Control Considerations... 81 14.1 Records Retention & Purging Historical Data... 81 14.2 Physical & Environment Security Controls... 81 15. Technical Data...82

15.1 Labels & Symbols... 82 15.1.1 Labels... 82 15.1.2 Symbols on the Labels... 85 15.1.3 Other Symbols on the Device... 87 15.2 Technical Specifications... 89 15.2.1 Environmental Specifications... 89 15.2.2 Device Performances... 89 15.2.3 Device Dimensions... 90 15.2.4 Robotic Arm Working Range... 91 15.3 Safety Classifications & Standards... 91 15.3.1 Cable Lengths... 92 15.4 Electromagnetic Compatibility... 93 15.4.1 Electromagnetic (EM) Emissions... 93 15.4.2 Electromagnetic Immunity... 94 15.4.3 Electromagnetic and Magnetic Immunity... 94 15.4.4 Electromagnetic Immunity and Portable and Mobile Radio Frequency (RF) Communication Equipment... 96 15.4.5 Recommended Separation Distances... 97 16. Software Licenses...98 16.1 Boost... 98 16.2 VTK... 98 16.3 GDCM... 99 16.4 ITK... 99 16.5 Open SSL... 101 Appendix A: Supported Implants and A/P Referencing by the ROSA Knee System...103 Appendix B: Implant Compatibility Between Femoral and Tibial Component Brands...106 Appendix C: Implant Compatibility Between Femoral and Tibial Component Sizes...106

1. General Information

1.1 Conventions This document employs the following conventions: WARNING: This symbol is present when a warning alerts you to a potential danger to health or life. CAUTION: This symbol is present to prevent a risk of deterioration of the equipment in case of a handling error. REMARK: This symbol is present to provide a general observation or information related to procedures, events or practices which are recommended or essential for a successful operation.

1.2 ROSA Knee System Description The ROSA Knee System is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.

The ROSA Knee System uses a Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of the surgical case. The case resides on the portal until it is uploaded to the ROSA Knee System before surgeries. If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (uses X-ray or MRI imaging inputs) to create a model of the patient’s femur/tibia and allows the preparation of a pre-operative surgical plan.

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1.2 ROSA Knee System Description (cont.) The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery and based on the surgical plan, the system mainly assists the surgeon in determining reference alignment axes in relation to anatomical landmarks, in planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry, in assisting in joint balancing and in precisely positioning the Cut Guide relative to the planned orthopedic implant location by using a Robotic Arm. CAUTION: Federal Law restricts this device to sale by or on the order of a physician.

1.3 Contact Zimmer CAS 75, Queen Street, Suite 3300 Montreal (Quebec), H3C-2N6 CANADA Tel.: 1 (514) 396-5422 ROSA Knee System Customer service: 1-855-ROSA-BOT zimmerbiomet.com

1.4 Training This device is a surgery assistance tool. It should only be used by authorized surgeons and healthcare professionals trained in the use of the device by Zimmer Biomet or by personnel authorized by Zimmer Biomet. It is not a replacement for the surgeon’s expertise and experience.

1.5 Intended Use The ROSA Knee System is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic surgery procedures. The system can also be used to assist in joint balancing techniques. The device must only be used for its intended use.

1.6 Indications For Use The ROSA Knee System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The Robotic Arm placement is performed relative to anatomical landmarks as recorded using the system intra-operatively, and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools. It includes a Robotic Arm, an optical tracking system and accessories, software system, surgical instruments and accessories. The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona IQ® The Smart Knee™, Vanguard® CR, and Vanguard PS.

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1.7 Contraindications The ROSA Knee System may not be suitable for use in case of: • Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum) • Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation) • Active infections of the knee joint area • Knee replacement revision surgery • Presence of strong infrared sources or infrared reflectors in the vicinity of the NavitrackER devices • Implants that are not compatible with the system • Contraindications for the implant as given by the implant manufacturer

1.8 Complications Possible complications associated with the use of the ROSA Knee System may include but are not limited to the following: • Infection • Implant misalignment • Unstable joint due to erroneous soft tissue balancing

1.9 Restrictions For Use The ROSA Knee System described in this user manual should not be used in combination with other products or components unless such other products or components are expressly recognized as compatible with ROSA Knee System. The list of compatible instruments are listed in section 3.3.3. • ROSA Knee system should not be used to perform surgery in applications other than those specified in this user manual. The device must only be used after reading this user manual and after receiving the appropriate training. Please contact Zimmer Biomet’s Customer Service if unsure on how to use the device. MR Unsafe: Keep away from Magnetic Resonance Imaging (MRI) Equipment.

1.10 Patents zimmerbiomet.com/patents

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2. About This Manual

This User Manual provides detailed information about the ROSA Knee System. Further, in this document, the ROSA Knee System can be referred to as “the device”. This manual is considered as the reference document for users. It is not a technical maintenance or service manual. For technical instructions about the device, please contact Zimmer Biomet’s Customer Service or one of its approved representatives. A troubleshooting guide is provided in Chapter 13- Post-operative Guide/Maintenance of this manual (section 13.6). The device must only be used after reading this user manual and after receiving the appropriate training. Please contact Zimmer Biomet’s Customer Service if unsure on how to use the device.

2.1 Safety 2.1.1 Warnings, Cautions and Remarks The correct use of this equipment implies that all the operating staff are familiar with the Instructions for Use. This manual must be carefully studied before using the device. Particular attention must be paid to the safety instructions related to people and the device. Training, Use and Maintenance Only properly trained, qualified personnel with appropriate credentials should operate the device. Users must follow safety guidelines and warnings. The device must only be used for its intended use. The device must only be used after reading this user manual and after having received the appropriate training. Please contact Zimmer Biomet’s Customer Service if unsure how to use the device. Do not open the device. In case of any issue or breakdown, do not intervene. Maintenance and service operations must only be carried out by Zimmer Biomet’s Customer Service or any of its approved representatives. Do not modify the device. Never attempt to clean the device when it is connected to a power supply. To avoid electrical discharges, always unplug the device from the wall outlet before cleaning or disinfecting it. A knee positioner, such as the De Mayo Knee Positioner®, is recommended to be used with the ROSA Knee System, otherwise accuracy may be impacted. When used in compliance with the indications for maintenance, the device can be run in permanent operation. Electrical Safety In order to avoid any risk of electric shock, the device must only be connected to an electric power network equipped with grounding. Device is class I, type BF. Do not simultaneously touch the patient and any component of the device other than those attached to the electrical isolation interface part.

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2.1.1 Warnings, Cautions and Remarks (cont.) IPX0 Protection: Device without special protection against the penetration of liquids. Do not pour any liquid over the device. Do not exceed the recommended input voltage for the device. Plugging the device to a higher voltage supply could damage the device. In order to prevent accidental detachment of connectors, ensure the metallic ring is attached to the Robotic Unit’s hook. Verify the metallic ring of the Optical Unit cable is attached to the hook on the Rear Panel of the Robotic Unit to ensure electromagnetic compatibility (EMC) protection. Do not connect to the Robotic Unit other elements than those provided with the device. Radiation Safety Risks generated by laser beam exposure: The device uses a laser integrated into the navigation camera. This laser is of class 2 (power inferior to 1 mW, eye protection by the palpebral reflex). Do not orient the laser beam to the eyes or to any light reflecting surfaces such as mirrors to avoid any direct or indirect exposure to laser beam. Do not orient the laser towards the patient’s eyes, the user’s eyes or anyone else’s eyes. MR Unsafe: Keep away from Magnetic Resonance Imaging (MRI) Equipment. The device requires specific precautions regarding the EMC. It must be set up and initiated according to the EMC information provided in this User Manual. Portable and mobile radio frequency communication devices might affect the operation of the device. Usage of accessories, transducers and cables other than those specified in the User Manual, with the exception of the transducers and cables sold by Zimmer Biomet (as spare parts of internal components), might cause increased emissions or decreased immunity of the device. The device must not be used adjacent to or stacked on top of any other equipment. If necessary, verify its correct operation in the corresponding configuration. Risks Related to Transport and Immobilization Ensure that the Robotic Unit is not moving once the immobilization system is locked. Risk of pinching: Do not place fingers or feet under the stabilization feet before immobilization of the system. Verify the position of the device and its environment when using the Robotic Unit immobilization system. During transportation, the device can be immobilized by activating the immobilization pedal. Do not install the device on an inclined surface, unless stability is guaranteed. Mechanical Safety Ensure that the Foot Pedal is operating correctly before beginning a procedure. Visually inspect the device and perform a test for interruption/resumption of a Robotic Arm movement.

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2.1.1 Warnings, Cautions and Remarks (cont.) Risks of collision: When the Robotic Unit is in Automatic mode, stay clear of the Robotic Arm and its path to the next position. Risks of arm dropping-off: Do not lean on the Robotic Arm. Risk of pinching: Do not place fingers in accessible parts of the plastic covers of the Robotic Arm. Risk of tracking interruption: Avoid passing obstacles between the camera and the patient reference or the Robotic Unit reference. Risk of navigation camera motion: Do not lean on the camera support arm. Verify the proper fixation of the navigation camera on the Optical Unit. The operating table must not be moved once an instrument guided by the Robotic Unit is connected to the patient anatomy. Test the Tracking mode before any instrument guided by the Robotic Unit is connected to the patient anatomy. Instruments Before every surgery, the user must verify that all instruments have been sterilized. Verify the integrity of all the instruments prior to each surgery. Visually inspect the instruments for damages Verify the proper fixation of the NavitrackER devices on each instrument (ROSA Base & Arm Reference Frame, ROSA Registration Pointer, Tibial & Femoral Reference Frame and Universal Validation Tool Body). Always use the NavitrackER pliers for installation. Verify the proper fixation of the percutaneous pins in the patient’s bone anatomy (femur and tibia). Verify the proper fixation of the patient references on the pins (femur and tibia). The femur and tibia references are secured on the pins, close to the patient’s skin (without compression), using two hexagonal screws. Bone references MUST be firmly attached to the bone and MUST NOT move at any point during surgery. In the case of a bone reference has moved, the landmarks digitized on that bone must be digitized again. Always verify the proper installation of an instrument to the Robotic Unit or Robotic Arm by making sure screws are firmly tightened. Verify the proper assembly of the Universal Validation Tool Body and the Distal & Posterior Condyles Digitizer before the acquisition of the posterior condyles or before validating the tibial proximal resection. Handle instruments with care. Avoid dropping instruments. Damage to an instrument can have a significant effect on the accuracy of the procedure and consequently, on the post-operative surgical outcome. At the end of the procedure, instruments are placed in their tray for sterilization. Do not apply excessive torque on screws when installing an instrument. Do not use power tools.

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2.1.1 Warnings, Cautions and Remarks (cont.) Contamination The device must be used with sterile drapes. These drapes must be installed in accordance with the instructions detailed in this User Manual. Verify the setup of the sterile drapes before beginning a surgery to ensure the asepsis of the surgical field. Use of the Software Continue pressing the Foot Pedal when pinning or drilling in Collaborative mode to enable the Bone Tracking mode, otherwise accuracy may be impacted. Visual and audio notifications are provided if the Foot Pedal is released in Collaborative mode. Specific Warning for the United States of America CAUTION: Federal Law restricts this device to sale by or on the order of a physician.

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3. Description

3.1 Overview The ROSA Knee System is a robotic platform that aims at assisting orthopedic surgeons with the bony resections as well as assessing the state of the soft-tissues to facilitate implant positioning during a total knee arthroplasty. Surgical planning software can be used pre-operatively by the surgeon to plan implant positioning and sizing. The surgeon may also use the imageless option within the ROSA Knee System to achieve the same goal as an image-based case. The device is composed of two units, one positioned on each side of the operating table: • A Robotic Unit consisting of a compact Robotic Arm and a Touchscreen • An Optical Unit and a Touchscreen The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery and based on the surgical plan, the system mainly assists the surgeon for: • Determining reference alignment axes in relation to anatomical landmarks • Planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry • Assisting in joint balancing • Precisely positioning the Cut Guide relative to the planned orthopedic implant location by using a Robotic Arm Optical Camera Robotic Arm Touchscreen

Touchscreen

Optical Unit

Robotic Unit

ROSA Knee System

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3.2 Operating Principle The operating principle for a total knee arthroplasty procedure is described below. 3.2.1 Case Information The case is launched with a USB drive plugged to the Robotic Unit using the case management application. The welcome screen of the software confirms the patient ID, procedure laterality, implant family and instrumentation. Once the user has confirmed the information, the ROSA Knee Software can be launched. 3.2.2 Pre-operative Planning Image-based cases The patient’s knee, reconstructed in 3D using pre-operative X-rays or MRI, can be used pre-operatively by the surgeon to plan the surgery. In this case, a 3D bone model will be displayed in some panels. If the registration of the landmarks taken intra-operatively and the patient knee reconstructed in 3D is unsuccessful, the user will have the possibility to redo the landmarks, or switch to an imageless case. Imageless cases If desired, the surgeon can decide not to plan the surgery prior to the surgery date, and use the ROSA Knee System directly intra-operatively. In this case, generic bone schematics will be displayed in the user interface. If a Persona IQ implant is used, please refer to the Persona IQ Surgical Technique in the Pre-operative Planning section. 3.2.3 OR Setup The patient is placed on the surgical table in supine position. The Robotic Unit is positioned approximately at the patient’s hip and approximately 45° relative to the surgery table. Two patient bone references are installed on the patient’s femur and tibia as a reference for leg movements. A third reference is located on the Robotic Unit (on the post of the ROSA Base Reference Bar closest to the surgical table), to track where the Robotic Unit is relative to the patient’s leg during the surgery. During the surgery, the surgeon must always stay on the same side as the Robotic Unit. The maximum height of the patient on the OR table should be 44 inches to minimize tracker visibility problems. In case of a patient with a high BMI, lower the table to avoid visibility problems. There are four possible OR setups: • Operating a right knee, with the surgeon on the same side as the operated knee • Operating a right knee, with the surgeon on the opposite side of the operated knee • Operating a left knee, with the surgeon on the same side as the operated knee • Operating a left knee, with the surgeon on the opposite side of the operated knee

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Right Knee

Left Knee

Surgeon same side as the operated knee

Surgeon opposite side of the operated knee

Possible OR Setups

44 in 111.76 cm

Maximum height of patient to minimize tracker visibility problems.

3.2.4 Robotic Unit Registration A registration of the Robotic Unit is performed with a fourth reference mounted on the Robotic Arm prior to the start of the surgery. This ensures the functional verification of the Robotic Arm prior to the start of the surgery. The patient should be in the OR for this step.

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3.2.4 Robotic Unit Registration (cont.) Risks of collision: When the Robotic Unit is in Automatic mode, stay clear of the Robotic Arm and its path to the next position. 3.2.5 Bony Landmarks & Navigation Using a registration pointer, the surgeon will digitize the bony landmarks to record the patient leg coordinate system (HKA alignment). Throughout the surgery, real-time tracking of patient movements is provided by the optical tracking system. 3.2.6 Planning If not done pre-operatively, the surgeon can set his surgical plan intra-operatively, i.e. the femur and tibia bone cuts according to preferences and the chosen implant components. If a Persona IQ implant is used, please refer to the Persona IQ Surgical Technique in the Pre-operative Planning and Sizing and Drilling of Tibia sections. 3.2.7 Surgery Based on the intra-operative planning values, the Robotic Arm will move to reach the appropriate positions to execute the bone resections. Risks of collision: When the Robotic Unit is in Automatic mode, stay clear of the Robotic Arm and its path to the next position. If the Femoral Rotation Assessment (optional) is selected, the ROSA Knee System provides clinical information to assist the surgeon in setting up the femoral rotation, taking into consideration the condition of the knee (medial and lateral gaps, as well as ligament laxity).

3.3 System Description 3.3.1 Robotic Unit The Robotic Unit is composed of the following main components: • The Robotic Arm • The Touchscreen for operating the device • The immobilization system • The Foot Pedal • The computer and software The Robotic Unit is equipped with swivel wheels and handles allowing the device to be easily moved from one operating room to the other by a single person. The wheels are equipped with foot pressure brakes to lock the unit in place and with cable pushers to avoid rolling on cables. It has lateral openings and a sliding shelf providing storage for various items. A fixed bar (ROSA Base Reference Bar) on the front side of the Robotic Unit is used to install the ROSA Base Reference Frame.

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3.3.1 Robotic Unit (cont.) The Robotic Unit is powered by the operating room power supply by plugging the power cable from the Rear Panel to a power plug compatible with the device characteristics. The Foot Pedal is linked to the Robotic Unit by plugging the cable to the dedicated connector on the Rear Panel. The Robotic Unit power cable and Foot Pedal cable can be rolled around rollers on the Rear Panel. The Foot Pedal may also be stored in the storage area.

Robotic Arm Touchscreen

Robotic Unit Base Sliding Shelf

Storage Areas

Wheels with Cable Pushers and Brakes

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Touchscreen Red EMERGENCY Button Sliding Shelf

Handle

CD/DVD Reader (optional)

USB Ports and RJ45 Port

Reset/Vigilance ON/OFF Switch Circuit Breaker

Rollers for Power Cable Optical Unit Connectors

Immobilization Pedal

Rear Panel

3.3.1 Robotic Unit (cont.) The Rear Panel includes: • The main ON/OFF switch to turn on and off the device • The RESET button to restart the PC • The CIRCUIT BREAKER button to restart the device after it has been turned off further to an overvoltage • The connectors to plug the Optical Unit and the Foot Pedal • The USB ports to import cases. CD/DVD reader is unplugged and non-functional. One USB port is available in the storage area beneath the sliding shelf to connect a mouse. • The RJ45 port to connect the system to an intra-operative imaging system (deactivated) • Controller servicing port (deactivated) • Laser button (deactivated) Do not connect to the Robotic Unit other elements than those provided with the device. In order to prevent accidental detachment of connectors, ensure the metallic ring is attached to the Robotic Unit’s hook. Make sure the metallic ring of the Optical Unit cable is attached to the hook on the Rear Panel of the Robotic Unit in order to ensure EMC protection. 3.3.1.1 Robotic Arm The Robotic Arm is equipped with a Force Sensor that manually moves the Robotic Unit to the desired location by measurement of forces exerted at the end of the arm and a compensation principle, regardless of the instrument used.

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3.3.1.2 Touchscreen The device includes two Touchscreens displaying the user interface, one on the Robotic Unit and one on the Optical Unit. 3.3.1.3 Immobilization System The Robotic Unit is equipped with a system immobilizing it to the ground. This system is composed of four stabilization feet, activated by a pedal. Two positions are available: the unit is immobilized when the pedal is down, the unit is mobile when the pedal is up. Additionally, each wheel of the Robotic Unit can be locked individually.

Pedal in down position immobilized

Pedal in up position mobile

Risk of pinching: Do not place fingers or feet under the stabilization feet before immobilization of the system. Verify the position of the device and its environment when using the Robotic Unit immobilization system. Make sure cables or wires are cleared from the area of the stabilization feet to prevent damage. 3.3.1.4 Vigilance Device (Foot Pedal) The device is equipped with a Foot Pedal for monitoring the Robotic Arm movements. The Robotic Arm will only move if the user presses the Foot Pedal. This operating principle applies to the SETUP and RESECTIONS panels. The Robotic Arm movement is interrupted as soon as the user releases the Foot Pedal.

Vigilance Device (Foot Pedal)

Ensure that the Foot Pedal is operating correctly before beginning a procedure. Visually inspect the device and perform a test for interruption/resumption of a Robotic Arm movement.

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