ROSA Partial Knee User Manual V1.1.1

Table of Contents

1. General Information... 2 1.1 Conventions... 2 1.2 ROSA Partial Knee System Description... 2 1.3 Contact... 3 1.4 Training... 3 1.5 Intended Use... 3 1.6 Indications For Use... 3 1.7 Targeted Population... 4 1.8 Implant Indication... 4 1.9 Contraindications... 4 1.10 Complications... 4 1.11 Restrictions For Use... 4 1.12 Patents... 4 2. About This Manual... 5 2.1 Safety: Warnings, Cautions and Remarks... 5 3. Description... 9 3.1 Overview... 9 3.2 Operating Principle... 10 3.3 System Description... 12 3.4 Instrument Assembly... 22 3.5 Disposables... 24 4. Installation... 26 4.1 Warnings and Cautions About Robotic Unit Installation... 26 4.2 Device Start Up... 27 4.3 Camera Errors... 27 4.4 Emergency Procedure... 28 4.5 Reverting to Standard Instrumentation... 28 4.6 Case Management Application... 29 5. Intra-operative Guide/Surgery... 30 5.1 Welcome Screen... 30 5.2 ROSA Partial Knee Application-User Interface Overview... 30 5.3 Robotic Modes... 33 5.4 Robotic Positions... 34 5.5 Application Audible Notifications... 34 5.6 Application Visual Notifications... 34 5.7 ROSA Partial Knee Application-Surgeon Panel... 36 6. ROSA Partial Knee Application-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... 42 7. ROSA Partial Knee Application-LANDMARKS Panel... 46 7.1 Femoral Head Center... 46 7.2 Malleoli... 47 7.3 Femoral Canal Entry... 47 7.4 Tibial Canal Entry... 47

7.5 Flexion Pose... 48 7.6 Extension Pose... 48 7.7 Tibial Tuberosity-PCL Axis... 48 7.8 Tibial Plateau Edge... 49 7.9 Tibial Plateau Resection Reference... 49 7.10 Tibial Sagittal Resection Reference... 49 7.11 Femoral Distal Condyle... 49 7.12 Femoral Posterior Condyle... 50 7.13 Landmarks Panel-Error Notifications... 50 7.14 Landmark Panel after Tibial Cut... 52 8. ROSA Partial Knee Application-EVALUATION Panel... 53 9. ROSA Partial Knee Application-PLANNING Panel in Image-based... 55 9.1 Planning Panel Overview... 9.2 Viewing Options... 58 9.3 HKA (Hip-Knee-Ankle) Angle & Plan Laxity Tool... 59 9.4 Femoral and Tibial Components Planning... 60 9.5 Validated Values... 62 10. ROSA Partial Knee Application-Resections Drawer... 66 10.1 Resections Drawer Overview... 66 10.2 ROSA Persona Partial Knee Cut Guide Installation and Checkpoint... 68 10.3 Tibial Proximal Resections... 68 10.4 Femoral Distal Resection... 70 10.5 Laxity Assessment (optional)... 72 10.6 Implant Confirmation Window... 74 10.7 Resections Drawer-Error Notifications... 74 10.8 Final Knee Evaluation... 75 11. Robotic Errors...76 11.1 Drifting of the Robotic Arm... 78 12. Post-operative Guide-Maintenance... 79 12.1 Retrieval of Post-Surgical Log File... 79 12.2 Shutdown... 80 12.3 Cleaning, Disinfection and Sterilization... 81 12.4 Storage and Transport... 84 12.5 Maintenance Operations... 85 12.6 Troubleshooting... 87 12.7 Product Security Customer Control Considerations... 90 13. Technical Data...91 13.1 Labels and Symbols... 91 13.2 Technical Specifications... 97 13.3 Safety Classifications and Standards... 100 13.4 Electromagnetic Compatibility... 101 13.5 Electromagnetic Immunity... 102 14. Software Licenses...106 14.1 Boost... 106 14.2 VTK... 106 14.3 GDCM... 107 14.4 ITK... 107 14.5 Open SSL... 109 14.6 JSON...110 15. APPENDIX A: Implants Supported by the ROSA Partial Knee System... 111

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 Partial Knee System Description The ROSA® Partial Knee System, for use with the ROSA Recon platform is used to assist surgeons in performing Partial Knee Arthroplasty (PKA) in the medial compartment 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 Partial 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 Partial Knee System before surgeries. If the case is based on pre-operative imaging (X-ray or MRI imaging modalities), patient specific bone models of the femur and tibia are generated by the PSI (Patient Specific Instrumentation) systems. The virtual patient case resides on the portal until it is uploaded to the ROSA Partial Knee System before surgeries.

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1.2 ROSA Partial Knee System Description (cont.) The intra-operative workflow and surgical steps of the system follow closely to conventional PKA surgery. As such, the system mainly assists the surgeon intra-operatively 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, and in precisely positioning the alignment instruments 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 (QC) H3C 2N6, Canada +1 514 396 5422 1 866 3D ORTHO http://www.zimmerbiomet.com

1.4 Training This device is a surgery assistance tool. It should only be used by authorized surgeons 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 Partial Knee System, for use with the ROSA Recon platform, 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 Partial Knee System, for use with the ROSA Recon platform, is indicated as a stereotaxic instrument system for Partial Knee Arthroplasty (PKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference to identifiable anatomical structures for the accurate placement of the knee implant components. The robotic placement is performed relative to anatomical landmarks as recorded using the system intra-operatively, and optionally based on a three-dimensional representation of the bone structures determined pre-operatively using compatible X-ray or MRI-based imaging technologies. It includes a Robotic Arm, an optical sensor navigation system and accessories, application system, surgical instruments and accessories.

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1.7 Targeted Population The ROSA Partial Knee System is designed for use on skeletally mature patient population. The targeted population, with the addition of the below contraindications, has the same characteristics of the population aimed by the implants compatible with the ROSA Partial Knee System.

1.8 Implant Indication The only implant compatible with the system is Persona® Partial Knee.

1.9 Contraindications The ROSA Partial 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 trackers. • Implants that are not compatible with the system. • Contraindications for the implant as given by the implant manufacturer.

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

1.11 Restrictions For Use The ROSA Partial 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 Partial Knee System. The list of compatible instruments is listed in section 3.3.3. The device must only be used after reading this user manual and after receiving the appropriate training. Please contact Zimmer Biomet Customer Service if unsure how to use the device. MR Unsafe: Keep away from Magnetic Resonance Imaging (MRI) Equipment.

1.12 Patents https://labeling.zimmerbiomet.com/

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2. About This Manual

This user manual provides detailed information about the ROSA Partial Knee System. Further, in this document, the ROSA Partial 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 Customer Service or one of its approved representatives. A troubleshooting guide is provided in Section 12- Post-operative Guide/Maintenance of this manual.

2.1 Safety: Warnings, Cautions and Remarks The correct use of this equipment implies that the operating staff is 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. 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 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 and thigh bump are recommended to be used with the ROSA Partial 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. The 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. IPX0 Protection: The device does not have any 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.

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2.1 Safety: Warnings, Cautions and Remarks (cont.) 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 any elements to the Robotic Unit other than those provided with the device. Radiation Safety Risks generated by laser beam exposure: the device uses a laser that is integrated into the Navigation Camera. This laser is of Class II (power inferior to 1 mW, eye protection by the palpebral reflex). Do not orient the laser beam toward 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 the device 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 Safety: 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 references or the Robotic Unit reference. Risk of Navigation Camera motion: Do not lean on the Camera Support. 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 damage. Verify the proper fixation of the NavitrackER devices on each instrument (ROSA Base & Arm Reference Frame, ROSA Registration Pointer, Tibial & Femoral Reference Frames, ROSA PKA Validation Tool). 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. If 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. 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 Safety: 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 Application Continue pressing the Foot Pedal when pinning or drilling in Collaborative mode to enable 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 Partial Knee System, with the ROSA Recon platform aims to assist orthopedic surgeons with bony resections and assessment of the state of soft tissues to facilitate implant positioning during a partial knee arthroplasty. The surgeon may also use the image-free option within the ROSA Partial 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 Touchscreen • An Optical Unit and Touchscreen The intra-operative workflow and surgical steps of the system closely follow those of conventional PKA surgery. As such, the system mainly intra-operatively assists the surgeon with: • Determining reference alignment axes in relation to anatomical landmarks. • Planning the orthopedic implant 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 the Robotic Arm.

Optical Camera Robotic Arm Touchscreen

Touchscreen

Optical Unit

Robotic Unit

ROSA Partial Knee System

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3.2 Operating Principle The operating principle for a PKA procedure is described below. 3.2.1 Case Information The case is launched with a USB drive plugged into the Robotic Unit using the case management application. The Welcome screen of the ROSA Partial Knee application confirms the patient ID, the procedure laterality and the implant. Once the user has confirmed this information, the ROSA Partial Knee application 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 to display a 3D bone model in some panels of the user interface. Images of the knee joint are taken pre-operatively and a reconstruction application is used to generate a 3D model of the patient’s bones. If the registration of the landmarks taken intra-operatively and the patient knee 3D bone model is unsuccessful, the user will have the possibility to retake the landmarks or switch to an image-free case. Image-Free Cases The ROSA Partial Knee System can be used without pre-operative X-rays or MRIs. In this case, generic bone schematics will be displayed on the user interface. A case on the Portal needs to be created to be able to download the case intra-operatively. 3.2.3 OR Setup The patient is placed on the OR 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 leg, one on the femur and one on the tibia, as a reference for leg movements. A third reference is placed on the Robotic Unit (on a surgical drape using the ROSA Base Reference Bar post closest to the surgical table), to track where the Robotic Unit is relative to the patient’s leg during the surgery.

44 in 111.76 cm 32 in 81.28 cm

Maximum and minimum height of patient to optimize tracker visibility.

During the surgery, the surgeon must always stay on the same side as the Robotic Unit.

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3.2 Operating Principle (cont.) 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. The minimum height of the patient on the OR table should be 32 inches to ensure the ability to reach the distal femur in full extension. There are four possible OR setups: • Operating on a right knee, with the surgeon on the same side as the operated knee • Operating on a right knee, with the surgeon on the opposite side of the operated knee • Operating on a left knee, with the surgeon on the same side as the operated knee • Operating on a left knee, with the surgeon on the opposite side of the operated knee Right Knee

Left Knee

Surgeon same side as the operated knee

Surgeon opposite side of the operated knee

Possible OR Setups

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 on the OR table for this step.

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3.2 Operating Principle (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’s leg coordinate system. Throughout the surgery, real-time tracking of patient movement is provided by the Optical Tracking System. 3.2.6 Planning The surgeon can only set the surgical plan intra-operatively. No pre-operative plan is available. 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 LAXITY ASSESSMENT feature (optional) is selected, the ROSA Partial Knee System provides clinical information to assist the surgeon in assessing the soft tissue condition of the knee between and after the cuts.

3.3 System Description 3.3.1 Robotic Unit The Robotic Unit is composed of the following main components: • Robotic Arm • Touchscreen for operating the device • Immobilization System • Foot Pedal • Computer and Software The Robotic Unit is equipped with swivel wheels and handles allowing the device to be easily moved between operating rooms 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. The Robotic Unit is powered by the operating room power supply by plugging the power cable from the rear panel to an outlet 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.

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3.3.1 Robotic Unit (cont.)

Robotic Arm

Touchscreen

Robotic Unit Base Sliding shelf

Storage areas

Wheels with cable pushers and brakes

Touchscreen 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 of the ROSA Robotic Unit

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3.3.1 Robotic Unit (cont.) The rear panel includes: • Main ON/OFF switch to turn the device on and off • Reset button to restart the computer • Circuit breaker button to restart the device after it has been turned off due to an overvoltage • Connectors to plug in the Optical Unit and Foot Pedal • USB ports to import cases • CD/DVD reader (unplugged and non-functional) • One USB port in the storage area beneath the sliding shelf to connect a mouse • RJ45 port to connect the system to an intra-operative imaging system (deactivated) • Controller servicing port (deactivated) • Laser button (deactivated) Do not connect any elements to the Robotic Unit other than those provided with the device. In order to prevent accidental detachment of connectors, ensure that 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 allows the surgeon to manually move 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.

3.3.1.2 Touchscreen The device includes two Touchscreens that display the user interface: one on the Robotic Unit and one on the Optical Unit.

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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.

Immobilized: Pedal in down position

Mobile: Pedal in up position

Risk of pinching: Do not place fingers or feet under the stabilization feet before immobilizing 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 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.

New

Original 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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3.3.2 Optical Unit The Optical Unit is composed of: • Optical Camera • Camera Positioning Arm • Touchscreen Risks generated by laser beam exposure: the device uses a laser integrated into the Optical Camera. This laser is Class II (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 toward the patient’s eyes, the user’s eyes or anyone else’s eyes. The Optical Unit is powered by the Robotic Unit by plugging the cable into the connector on the Robotic Unit’s rear panel. A roller is included to properly store the Optical Unit cable. The Optical Unit is equipped with swivel wheels and a handle allowing the device to be easily moved between operating rooms by a single person. Each wheel has a brake and a cable pusher system. A laser is integrated into the camera to facilitate the camera positioning and orientation adjustments during the device installation in the operating room. Positioning Arm

Optical Camera

Touchscreen

Handle

Wheels

ROSA Optical Unit 16 | ROSA® Partial Knee System

3.3.3 Instrumentation

All reusable instruments need to be sterilized before each use. ROSA Knee General Instruments Component Name

Part Number

3.5MM HEX SCREWDRIVER

00-5120-087-00

2 PINS REFERENCE FEMUR TS3

20-8000-010-33

ROSA TIBIA REFERENCE A

20-8020-028-00

ROSA TIBIA REFERENCE B

20-8020-029-00

CAS NAVITRACKER PLIERS

20-8000-070-05

ROSA BASE REFERENCE FRAME

20-8020-002-00

ROSA ARM INSTRUMENT INTERFACE

20-8020-004-00

ROSA REGISTRATION POINTER

20-8020-013-00

ROSA ARM REFERENCE FRAME

20-8020-015-00

ROSA Modular Instruments Component Name

Part Number

ROSA PKA VALIDATION TOOL

20-8020-034-00

ROSA PERSONA PARTIAL KNEE MEDIAL Cut Guide A-L (Left)

20-8020-030-00

ROSA PERSONA PARTIAL KNEE MEDIAL Cut Guide A-R (Right)

20-8020-031-00

ROSA PERSONA PARTIAL KNEE MEDIAL Cut Guide B-L (Left)

20-8020-032-00

ROSA PERSONA PARTIAL KNEE MEDIAL Cut Guide B-R (Right)

20-8020-033-00

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3.3.3 Instrumentation (cont.)

Disposables Disposable Name for Bone References Installation

Part Number

Fixed Fluted Pin 3.2x150 mm (non-sterile)

20-8000-000-01

Fixed Fluted Pin 3.2x80 mm (non-sterile)

20-8000-000-02

Fixed Fluted Pin 3.2x150 mm

20-8000-000-10

Fixed Fluted Pin 3.2x80 mm

20-8000-000-11

Disposable Name for Pinning Cut Guides

20-8020-033-00

Trocar Tipped Drill Pin (2.5 mm hex) 3.2x75 mm (Persona)

00-5901-020-00

CAS 3.2 mm Headless Trocar Drill Pin

20-8000-000-16

Disposable Name for Pinning Cut Guides

Part Number

NavitrackER Kit A: Knee

20-8000-000-07

ROSA Robotic Unit Drape

20-8020-080-00

ROSA Arm Drape

ROSAS00055

Monitor Drape

ROSAS00056

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. 3.3.3.1 ROSA Arm Instrument Interface The ROSA Arm Instrument Interface is attached to the Robotic Arm in sterile conditions using three captive screws. It enables maintaining sterile conditions when changing tools. This part must be sterilized before each use. To avoid touching the non-sterile part of the Robotic Unit and to preserve sterility, always use the handles to hold the ROSA Arm Instrument Interface in place during installation. 3.3.3.2 ROSA Arm Reference Frame The ROSA Arm Reference Frame is attached to the Robotic Arm Interface with two captive screws. It is used during the Robotic Unit registration prior to the start of the surgery. This part must be sterilized before each use.

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