ROSA Hip User Manual and Surgical Technique V1.0 Dec 2021

Table of Contents

1. General Information... 1 1.1 Conventions... 1 1.2 ROSA® Hip 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... 7 3.1 Overview... 7 3.2 Operating Principle... 8 3.2.1 Case Information... 8 3.2.2 ROSA Tablet and ROSA Communication Setup... 8 3.2.3 Surgeon’s Preferences and Pre-operative Planning... 8 3.2.4 Reference Fluoroscopic Images Acquisition... 8 3.2.5 OR Setup... 8 3.2.6 Acetabular Component Impaction... 9 3.2.7 Trial and Validation... 9 3.3 System Description... 9 3.3.1 Robotic Unit... 9 3.3.2 Optical Unit... 12 3.3.3 ROSA Tablet... 14 3.3.4 Instrumentation... 15 3.4 Instrument Assembly... 17 3.4.1 ROSA Quick Connect... 17 3.4.2 ROSA Cup Inserter Assembly (Straight and Offset)... 18 3.5 Instrument Installation on the Robotic Arm... 21 3.5.1 ROSA Quick Connect on the Robotic Arm... 21 3.5.2 Instrument Installation... 21 3.5.3 Drapes... 22

4. Installation... 23 4.1 Warnings and Cautions About Robotic Unit Installation... 23 4.2 Device Start Up... 24 4.3 Emergency Procedure... 24 4.3.1 Moving the Robotic Arm Away Using ROSA Application Interface... 24 4.3.2 Moving the Robotic Arm Away if Application is Unresponsive... 25 4.4 Reverting to Standard Instrumentation... 25 4.5 Case Management Application... 26 4.5.1 Case Management Application-Interface Overview... 26 4.5.2 Starting a Case... 26 5. ROSA Tablet Handling... 27 5.1 Battery Charger Installation... 27 5.2 Charging Procedure... 28 5.3 ROSA Tablet Battery Removal/Installation Procedure... 28 5.4 Turning ON the ROSA Tablet... 29 5.5 Intra-operative Battery Swap... 30 5.6 Turning OFF the ROSA Tablet... 30 6. Intra-operative Guide/Surgery... 31 6.1 Welcome Screen... 31 6.2 ROSA Hip Application-User Interface Overview... 31 6.2.1 Top Task Bar... 31 6.2.2 Bottom Task Bar... 31 6.3 Robotic Modes... 34 6.4 Robotic Positions... 35 6.5 Application Audible Notifications... 35 6.6 Application Visual Notifications... 35 7. ROSA Hip Application-MOBILE Panel... 37 8. ROSA Hip Application-SURGEON Panel... 38 9. ROSA Hip Application-SETUP Panel... 39 9.1 DRAPING... 39 9.2 Touchscreen Monitor DRAPING... 40 9.3 Calibration of Sensor... 41 9.4 Reference Images Acquisition... 41 9.5 ROSA Positioning... 46

10. ROSA Hip Application-IMPACTION Panel... 48 10.1 Attach Instrument... 48 10.2 Calibration Image Acquisition... 49 10.3 Navigation Image Acquisition... 51 10.4 Target Orientation... 54 10.5 Impaction... 54 10.6 Out... 55 11. ROSA Hip Application-CUP VERIFICATION Panel... 56 12. ROSA Hip Application-TRIAL Panel... 58 12.1 Trial Image Acquisition... 58 12.2 Leg Length and Offset Discrepancies Computation... 60 12.3 Final Image Acquisition... 61 12.4 Current Implant System... 63 12.5 Leg Length and Offset Discrepancies Computation... 63 13. Robotic Errors... 64 13.1 Collision Detection... 64 13.2 Excessive Force on the Robotic Arm... 64 13.3 Emergency Red Button... 65 13.4 Unknown Robotic Error... 65 13.5 Drifting of the Robotic Arm... 65 14. Post-operative Guide/Maintenance... 66 14.1 Retrieval of Post-Surgical Log File... 66 14.1.1 Surgeon Report... 66 14.1.2 Investigation Logs... 66 14.2 Shutdown... 67 14.3 Cleaning, Disinfection and Sterilization... 67 14.3.1 Cleaning the Robotic and Optical Units... 67 14.3.2 Cleaning the ROSA Tablet... 68 14.3.3 Cleaning the Optical Camera (if Optical Unit touchscreen was used)... 68 14.3.4 Instrument Reprocessing (Cleaning and Sterilization Methods)... 68 14.3.4.1 ROSA Hip System Instrument Kit... 69 14.3.4.2. ROSA Hip System Instrument Lifetime Expectancy... 70 14.4 Storage and Transport... 70 14.4.1 Storage and Protection... 70 14.4.1.1 Device Storage and Protection... 70 14.4.1.2 Instrument Storage and Protection... 70 14.4.1.3 Care of Cables and Connectors... 71 14.4.2 Device Transport... 71 14.5 Maintenance Operations... 71 14.5.1 Installation... 71 14.5.2 Daily Checks... 72 14.5.3 Periodic Maintenance... 72 14.6 Troubleshooting... 73

15. Technical Data... 75 15.1 Labels and Symbols... 75 15.1.1 Labels... 75 15.1.2 Symbols on the Labels... 76 15.1.3 Other Symbols on the Device... 78 15.2 Technical Specifications... 81 15.2.1 Robotic and Optical Units Environmental Specifications... 81 15.2.2 ROSA Tablet and Battery Environmental Specifications... 81 15.2.3 Device Dimensions... 82 15.2.4 Robotic Arm Working Range... 83 15.3 Safety Classification and Standards... 83 15.3.1 Cable Lengths... 85 15.4 Electromagnetic Compatibility... 85 15.4.1 Electromagnetic (EM) Emissions... 86 15.5 Electromagnetic Immunity... 86 15.5.1 Electromagnetic and Magnetic Immunity... 86 15.5.2 Electromagnetic Immunity and Portable and Mobile Radio Frequency (RF) Communication Equipment... 88 15.5.3 Recommended Separation Distances... 89 16. Application Licenses... 90 16.1 Boost... 90 16.2 Open SSL... 90 16.3 OpenCV... 92 16.4 JSON... 92 16.5 Libgit2... 93 17. Product Security Customer Control Considerations... 94 17.1 Records Retention and Purging Historical Data... 94 17.2 Cybersecurity... 94 Appendix A: Supported Implants Supported by the ROSA Hip System...95 Appendix B: Leg Length and Offset Measurements Method... 102 Appendix C: Image Acquisition, Landmarking and Overlay Guidelines...104

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 Hip System Description The ROSA Hip System (RHS) for use with the ROSA RECON platform (PN 20-8020-100-01/17/26) is used to assist surgeons in performing Total Hip Arthroplasty (THA) with features to assist with the acetabular shell impaction for the direct anterior approach, as well as assessing the leg length discrepancy and the femoral offset. The ROSA Hip System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal, which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA RECON Platform before surgeries. The ROSA Hip System utilizes the robotic arm of the ROSA RECON Platform cleared in K182964, but does not add new stereotaxic or robotic components The system uses fluoroscopic images to determine the instruments’ orientation in relation to the patient anatomy and as a guide for acetabular component orientation. The system allows the surgeon to input the case’s surgical pre-operative planning values and preview the acetabular component orientation intra-operatively. Throughout the surgical workflow, fluoroscopic images are acquired with a C-Arm. Fluoroscopic images are then captured with the ROSA Tablet and transferred onto ROSA. The current instruments’ orientation is computed from the image capture and is adjusted to match the surgeon’s planning values using the ROSA RECON Robotic Arm. The system provides pre, intra and post-operative measurements relative to patient anatomy and does not provide infrared-based stereotaxic navigation for implant placement. The Robotic Arm is maintained stationary to keep the instruments in a fixed orientation during acetabular component impaction. The system also provides component selection options based on leg length and offset discrepancies measurements. The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional THA direct anterior approach workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) determining reference alignment axes and cup orientation using image-to-image and robotic registration, (2) precisely orienting the cup inserter relative to the desired orthopedic implant angle by using a Robotic Arm, and (3) providing leg length and offset discrepancies measurements based on fluoroscopic image references. CAUTION: Federal Law restricts this device to sale by or on the order of a physician.

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1.3 Contact Zimmer CAS 75, Queen Street, Suite 3300 Montreal (Quebec), H3C-2N6 CANADA Tel.: 1 (514) 395-8883; Fax: 1 (514) 878-3801 ROSA Hip System Customer Service: 1-855-ROSA-BOT www.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 Hip System, for use with the ROSA RECON platform, is intended to assist the surgeon in providing application-defined spatial boundaries for orientation and reference information to anatomical structures during hip orthopedic surgery procedures. The device must only be used for its intended use.

1.6 Indications For Use The ROSA Hip System, for use with the ROSA RECON platform, is indicated as a fluoroscopic-guided system for total hip arthroplasty (THA). It is used to assist the surgeon in providing application-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of hip implant components provided that the points of interest can be identified from radiology images. The intra-operative cup placement is performed relative to anatomical landmarks as recorded using the system intra-operatively, and based on pre-operative planning values optionally determined using compatible X-Ray based surgical planning tools. The ROSA Hip System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Hip System. The ROSA Hip System is not for primary image interpretation and is applicable for the direct anterior approach. The ROSA Hip System is to be used with the following hip replacement systems in accordance with their indications and contraindications: G7® Acetabular System, Avenir® Hip System, Avenir Complete® Hip System, Taperloc® Complete Hip System, Echo® Hip System.

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1.7 Contraindications The ROSA Hip 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). • Active infections of the hip joint area. • Hip replacement revision surgery. • Presence of undesirable radio-opaque element during intra-operative image acquisition. • Contraindications for the implant as given by the implant manufacturer. • Implants that are not compatible with the system.

1.8 Complications Possible complications associated with the use of the ROSA Hip System may include but are not limited to the following: infection, implant misalignment.

1.9 Restrictions For Use The ROSA Hip 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 the ROSA Hip System. The list of compatible instruments are listed in section 3.3.4. MR Unsafe: Keep away from Magnetic Resonance Imaging (MRI) Equipment.

1.10 Patents Patents available online at zimmerbiomet.com/patents

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2. About This Manual

This user manual provides detailed information about the ROSA Hip System. Further in this document, the ROSA Hip 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 section 14 of this manual: Post-operative Guide/Maintenance.

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 these 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 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. 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’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. Make sure the ROSA Tablet has sufficient battery charge before starting surgery. Avoid dropping the ROSA Tablet. Damage to the ROSA Tablet can affect its proper function during surgery. Regarding C-Arm compatibility, only Image Intensifier of 9’’ or 12’’ diameter can be used. Flat-panel detectors are not supported by the system. 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 into 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 any other elements to the Robotic Unit 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.

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2.1.1 Warnings, Cautions and Remarks (cont.) 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 Robotic Arm movement. 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. Instruments Before every surgery, the user must verify that all instruments are clean and sterilized as per instructions. Verify the integrity of all instruments prior to each surgery. Visually inspect the instruments for damages. Make sure that the quick connect interface screws are firmly tightened. Handle instruments with care. Avoid dropping instruments. Damage to an instrument can have a significant effect on the function and 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 cleaning and sterilization. Do not apply excessive torque on screws when installing an instrument. Do not use power tools. Contamination The device must be used with sterile drapes. These drapes must be installed in accordance with the instructions detailed in section 9.1 of this User Manual. Verify the setup of the sterile drapes before beginning a surgery to ensure the asepsis of the surgical field. 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 A part of the ROSA RECON robotic platform, the ROSA Hip System is an application that assists orthopedic surgeons with acetabular component impaction, inclination and version measurements, as well as assessing the leg length and offset discrepancies based on fluoroscopic images acquired intra-operatively during a total hip arthroplasty. The ROSA Tablet is utilized to capture the fluoroscopic images and transfer data onto the robotic platform. Pre-operative planning values related to implant positioning and sizing can be entered in the system as an option. The device is composed of three units: • A Robotic Unit consisting of a compact Robotic Arm and touchscreen • An Optical Unit and touchscreen (optional) • A ROSA Tablet with a touchscreen The intra-operative workflow and surgical concepts implemented in the system are aligned with the conventional THA direct anterior approach workflow. As such, at the time of the surgery and based on the surgical plan, the system assists the surgeon in determining the reference alignment axis in relation to anatomical landmarks, in positioning the corresponding instruments relative to the planned orthopedic implant orientation and in assessing the leg length and offset discrepancies. Robotic Arm Touchscreen

ROSA Tablet

Robotic Unit

Figure 1: ROSA Hip System

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3.2 Operating Principle The operating principle for a total hip arthroplasty procedure is described below. 3.2.1 Case Information The case is launched with a USB drive that is plugged into the Robotic Unit using the case management application. The welcome screen of the ROSA Hip application confirms the patient ID, procedure laterality and surgeon’s name. Once the user has confirmed the information, the ROSA Hip application can be launched on the robotic platform. The ROSA Hip application is launched on the ROSA Tablet directly without launching a specific case. 3.2.2 ROSA Tablet and ROSA Communication Setup The communication between the ROSA Tablet and robotic platform can be established when the ROSA Hip application is launched on both devices and Wi-Fi is turned on. The ROSA Tablet is operated by a non-sterile operator and used to capture fluoroscopic images from the C-Arm monitor and transfer them to the Robotic Unit. It can also be used to control the ROSA Hip application throughout the workflow. 3.2.3 Surgeon’s Preferences and Pre-operative Planning The surgeon’s preferences are automatically selected when launching the ROSA Hip application if they were defined in the Zimmer Biomet Drive Case Management System (DCMS). The preferences can be modified intra-operatively in the ROSA Hip application. Optional pre-operative planning values can be selected when launching the ROSA Hip application if pre-operative planning was performed with X-ray based surgical planning tools. The implant sizing values and target values can be modified intra-operatively in the ROSA Hip application. 3.2.4 Reference Fluoroscopic Images Acquisition Reference fluoroscopic images are acquired using the ROSA Tablet and transferred to the Robotic Unit through a wireless connection. The images are used to define the patient’s reference axis in relation to anatomical landmarks and to determine the pre-operative leg length and offset measurements. 3.2.5 OR Setup The patient is placed on the operating table in supine position. It is recommended to use standard OR stabilization devices to limit pelvis movement. The Robotic Unit is positioned on the operative side, at approximately the patient’s hip level and approximately 90° relative to the operating table. The maximum height of the patient on the OR table should be 48 inches to ensure adequate Robotic Arm movement. During the surgery, the surgeon must always stay on the same side as the Robotic Unit. These recommendations are also applicable when the use of a traction table is preferred.

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3.2.6 Acetabular Component Impaction Acetabular component target angles can be modified prior to cup insertion. Based on the intra-operative planning values and intra-operative fluoroscopic images, the Robotic Unit provides live feedback on the instrument orientation to guide the acetabular component orientation during impaction. Based on cadaveric testing, the system achieved cup placement accuracy within the Lewinnek and Callanan safe zones in 100% of cases for both inclination and version. Risks of collision: When the Robotic Unit is in automatic mode, stay clear of the Robotic Arm and its path to the next position. 3.2.7 Trial and Validation Based on intra-operative fluoroscopic images, the ROSA Hip application will determine the intra-operative leg length and offset discrepancies for the selected trial components and final implants. The ROSA Hip application also shows the projected leg length and offset values for compatible combination of components. Based on cadaveric testing, the system achieved measurement accuracy of ±5 mm of leg length discrepancy in 88% of cases and ±5 mm of offset discrepancy in 87% of cases.

3.3 System Description 3.3.1 Robotic Unit The Robotic Unit (PN 20-8020-110-01/17/26) is composed of the following main components: • Robotic Arm • Touchscreen for Operating the Device • Immobilization System • Foot Pedal • Computer and Application The Robotic Unit is equipped with swivel wheels and handles allowing the device to easily move 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 cable pushers to avoid rolling on cables. It has lateral openings and a sliding shelf that provides storage for various items. 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. When not in use, 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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Robotic Arm Touchscreen

Sliding shelf Robotic Unit base

Storage areas

Wheels with cable pushers and brakes

Figure 2: Front View of ROSA Unit

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

Figure 3: 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 that turns the device on and off • Reset button to restart the PC • Circuit breaker button to restart the device after it has been turned off due to an overvoltage • Connectors that plug in the Optical Unit and the foot pedal • USB ports to import cases. One USB port is available in the storage area beneath the sliding shelf to connect a mouse. • CD/DVD reader (unplugged and non-functional) • RJ45 port to connect the system to an intra-operative imaging system (deactivated) • Controller servicing port (deactivated) • Laser button (deactivated) Do not connect any other elements besides those provided with the device to the Robotic Unit. 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 Unit is equipped with a force sensor in the Robotic Arm that allows it to be manually moved 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 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, activated by a pedal.

Stabilization Foot

Pedal in down position: unit immobilized

Pedal in up position: unit mobile

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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. 3.3.1.3 Vigilance Device (Foot Pedal) The device is equipped with a foot pedal (PN RF 2PW-MED or MKF 2S-MED) for monitoring the Robotic Arm movements. The Robotic Arm will only move if the user presses down on the foot pedal. This operating principle applies to the SETUP and IMPACTION panels. The Robotic Arm movement is interrupted as soon as the user releases the foot pedal.

Figure 4: 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 Robotic Arm movement. 3.3.2 Optical Unit The Optical Unit (PN 20-8020-120-01) is composed of: • Optical camera • Camera positioning arm • Touchscreen The optical camera is not used for the Direct Anterior approach with the ROSA Hip system since the system relies on fluoroscopic images. The Optical Unit can be optionally connected to the Robotic Unit for usage of the touchscreen. The Optical Unit is powered by the Robotic Unit by plugging the cable to the connector on the Robotic Unit 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 from one operating room to the other by a single person. Each wheel has a brake and a cable pusher system. A laser is integrated into the camera but is not used with the ROSA Hip System.

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3.3.2 Optical Unit (cont.)

Positioning arm

Optical camera

Touchscreen

Handle

Wheels with cable pushers and brakes

Figure 5: Vigilance Device (Foot Pedal)

Risks generated by laser beam exposure: The device uses a laser integrated into the optical camera. This laser is of class 2 (power inferior to 1 W, 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.

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3.3.3 ROSA Tablet The ROSA Tablet is a non-sterile digital tablet approved for use in surgical environment. It is provided with the following non-sterile electronic accessories: • Tablet Battery, corresponding to the battery of ROSA Tablet. • Battery Bay Charger, corresponding to the 6-slotted battery charger. • Power Cord, corresponding to the country-associated power cable for Battery Bay Charger. Two Tablet Batteries, one Battery Bay Charger and one Power Cord provided in the initial package with the ROSA Tablet.

The ROSA Tablet has a wireless connection to the Robotic Unit, established after the ROSA Hip application is launched. The Battery Bay Charger is not approved for use in a surgical environment.

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3.3.4 Instrumentation

ROSA Instruments All reusable instruments need to be sterilized before each use. Component’s Name

Part Number

ROSA Quick Connect Interface

20-8060-001-00

ROSA Quick Connect Sleeve

20-8060-002-00

ROSA Cup Inserter Handle

20-8060-301-00

ROSA STRT Cup Inserter Shaft

20-8060-302-00

ROSA OFFST Cup Inserter Shaft

20-8060-303-00

ROSA Cup Inserter Adaptor

20-8060-304-00

ROSA Cup Inserter Screw

20-8060-305-00

ROSA Hip Impaction Instrument Case

20-8060-306-00

Instrument Case Lid

110031221

Disposables Component’s Name

Part Number

ROSA Robotic Unit Drape (box of 20)

20-8020-080-00

Monitor Drape (box of 20)

ROSAS00056

ROSA Tablet Component’s Name

Part Number

ROSA Tablet

20-8060-400-00

Tablet Battery

20-8060-402-00

Tablet Battery Bay Charger

20-8060-403-00

Tablet Power Cord Type (I)

20-8060-400-02

Tablet Power Cord Type (B)

20-8060-400-03

Tablet Power Cord Type (G)

20-8060-400-04

Tablet Power Cord Type (L)

20-8060-400-05

Tablet Power Cord Type (M)

20-8060-400-06

Tablet Power Cord Type (J)

20-8060-400-07

Tablet Power Cord Type (H)

20-8060-400-08

Tablet Power Cord Type (N)

20-8060-400-09

Tablet Power Cord Type (E–F)

20-8060-400-10

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