ROSA Knee Hospital Launch Guide

TABLE OF CONTENTS ROSA Knee System Overview...2 ROSA Launch Summary Guide...3 Delivery and Installation...4 OR Staff In-Service Training...5 ROSA Knee X-Atlas™ Imaging Process...6 ROSA Knee X-Atlas Protocol Checklist...7 Central Sterile Services Department (CSSD) In-Service Training...8 Surgeon Credentialing...9 Appendix... 10

ROSA KNEE SYSTEM OVERVIEW Optical Camera Robotic Arm

Touchscreen

Touchscreen The ROSA Knee System is a robotic platform that is designed to assist orthopaedic surgeons with the bony resections as well as assessing the state of the soft-tissues to facilitate implant positioning. 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 User Interface of the ROSA Knee System is intuitive and guided throughout the procedure via a touchscreen. Optical Unit Robotic Unit

ROSA Knee System

2 | ROSA Knee System

ROSA LAUNCH SUMMARY GUIDE Choosing the ROSA Knee System will not just give you access to a distinctive medical technology but also a differentiated customer experience. We want to be your trusted partner in robotic technology and we have established a standardised process to support you with different initiatives and activities.

1. Welcome Letter

2. Kick-off Meeting

Our ROSA implementation program starts with a detailed welcome letter as soon as commercial contracts have been signed. You will be introduced to the ROSA team which will be personally responsible for your integration every step of the way. We will explain, in detail, next steps to ensure proper planning and alignment between your hospital and our team.

At your earliest convenience, our Clinical Support Team will organise a kick-off meeting with the Nurse Unit Manager (NUM) to inform about pre-delivery activities, training curriculum, pre-operative planning process and first case support. This meeting is intended to inform you about all relevant steps in the ROSA Knee onboarding process. The NUM will then be provided with all paperwork such as instrument IFU, TGA letter, quick reference guides etc.

3. Technical Installation and Support Our Technical Support Team will get in contact with all relevant stakeholders at your hospital to make sure we comply with internal processes when installing the ROSA Knee System. The team will run various validation tests and will inform you once the system is ready for clinical use. You should then expect to receive regular technical services support throughout your time with ROSA. This is expected to be every 3 months, in addition to software updates that will be installed as they become available.

4. Hospital Staff Training It is critical that the hospital staff is fully trained on the system to support a smooth procedure in the OR. Our onboarding training curriculum ensures that the hospital staff receives the necessary theoretic and hands-on training. Our Clinical Support Team is dedicated to provide various high quality training sessions to various specialists in the hospital.

5. Clinical Case Support

6. Utilisation Plan

Our Clinical Support Team is manned by specialists trained in robotic surgeries who are responsible for providing onsite guidance and assistance during first surgical procedures to overcome the learning curve. The Clinical Support Team provides you with feedback on the use of the product to provide you with a differentiated user experience.

Together with you, the ROSA Sales Team will create a monthly utilisation plan which will be reviewed periodically. This way we can make sure utilisation is to your fullest satisfaction. If not, we can identify challenges early in the process and can have an open discussion about how to strengthen our commercial partnership.

3 | ROSA Knee System

DELIVERY AND INSTALLATION •

Implants will be supplied by your Zimmer Biomet representative through the normal process. Ensure PO is submitted for initial consumables with appropriate stocking levels in time for first scheduled cases.

650

1205 1020

•

771

845

Robotic Unit Dimensions (cm)

1945

Please confirm where the ROSA installation will take place in your facility with your local ROSA representative. Installation Sign Off • Your Biomed department may need to review the ROSA installation prior to use, please liaise with them if this is a requirement at your facility. • The ROSA installation documents will require your review, and signature once complete. A copy of the installation documents will be provided upon completion. Delivery of Implants & Consumables • Your Regional Sales Manager (RSM) is your primary contact for questions regarding disposables. • Please note an order for the required ROSA consumables will need to be placed during your installation and before cases can commence at your facility. A full consumable order list can be found in the appendix of this document.

•

1500

Delivery of your ROSA Knee System • Two large crates and one pallet will arrive to your specified loading dock on the date you indicate − Crate Dimensions: Robot Crate: 157 x 89 x 170cm (62 x 35 x 67 in) − Camera Crate: 107 x 92 x 215 cm (42 x 36 x 85 in) • Please confirm your preferred delivery location, time & date to your local Zimmer Biomet representative. • Please let us know of any special requirements for delivery your facility may have to ensure smooth delivery of your ROSA system. ROSA Knee System Installation Requirements • A ROSA Field Service Engineer (FSE) will be on-site to unpack and install the ROSA system on the date specified. • The FSE will require access to the loading dock and a space the size of an OR or conference room for one to two days to complete the full installation of your robot.

761

Optical Unit Dimensions (cm)

Robotic unit weight: Approximately 320kg (705 lb) Optical unit weight: Approximately 140 kg (309 lb)

4 | ROSA Knee System

OR STAFF IN-SERVICE TRAINING Identify a Robotics Coordinator • It is recommended to identify a robotics coordinator within your facility. This person would be the primary point of contact with whom the Zimmer Biomet representative can coordinate all ROSA Program Launch activities. • Identify key stakeholders in the hospital in order to help establish key OR staff for initial in-service training. • Please coordinate with your local Zimmer Biomet representative if you require further training for staff following the initial launch. In-service Training for OR Staff • During the launch activities the ROSA launch team will provide training for your OR staff. This training requires around 2 hours during which we will review: − Back table set up with instruments and disposables − Setting up & draping − OR logistics − Best practices for a successful ROSA program

5 | ROSA Knee System

ROSA KNEE X-ATLAS™ IMAGING PROCESS A Zimmer Biomet representative will liaise with the surgeon(s) to identify an appropriate radiology site where patients will receive pre-operative X-rays. A Zimmer Biomet X-Atlas Technician will setup and complete in-servicing of the nominated radiology site. Following setup and in-servicing, the surgeon(s) may begin referring the patient for X-Atlas X-Rays. NOTE – no assistance is required from OR staff during the radiology process.

•

•

•

•

Zimmer Biomet Reconstructive Team will complete the ROSA X-Atlas Imaging Registration Form with appropriate contacts from the imaging facility and send it to the Zimmer Biomet Personalised Solutions ROSA team. Personalised Solutions will reach out to the appropriate contacts to schedule a conference call to go over the imaging protocol and options for IT connection. Imaging facility must submit a test scan (Reference ROSA X-Atlas Protocol, 2535.2-GLBL-en to approve the imaging facility for ROSA imaging). After test scan submitted, Personalised Solutions will contact imaging facility to schedule on-site training during the first ROSA patient x-rays.

6 | ROSA Knee System

ROSA KNEE X-ATLAS PROTOCOL CHECKLIST Step #

Activity

1

Order XPSI Calibration Kit (#20-8085-020-00)

REC

2

Meet with surgeon and determine Scan Centre location(s)

REC

Complete and submit forms included in Welcome Packet

REC

Email PS the Scan-Site Registration Form

REC

Email PS MedEd training form and Surgeon Preferences Sheet

REC

4

Train Scan Centre on X-Ray/X-Atlas protocols and go over IT protocol options via Webex *Refer to X-Ray Protocol and Guide

PS

5

Send test x-ray scans to PS for image processing

PS

Process test scans to determine pass/fail status

PS

If test x-ray scans pass, send success confirmation email to Scan Centre (“Cc’d” REC, RSM, PDM)

PS

If test x-ray scans fail send rejection notification email to Scan Centre (“Cc’d” REC, RSM, PDM) and provide additional training in area(s) required. Monitor Imaging Centre’s progress. If additional training is not successful (i.e., two failed scans) then schedule a group call with the REC, RSM, and PDM to decide if on-site training needs to be scheduled.

PS

Create new ROSA case on SMS and provide all required patient information (upload patient x-ray scans manually if required)

REC

Process patient x-ray scans to determine pass/fail status

PS

If patient x-ray scans pass, send success confirmation email. Upload ROSA plans to SMS

PS

If patient x-ray scans fail, send rejection notification email to Scan Centre (“Cc’d” REC, RSM, PDM). Contact Scan Centre directly to provide additional training in area(s) required. Monitor Imaging Centre’s progress. If additional training is not successful (i.e., two failed scans) then schedule a group call with the REC, RSM, and PDM to decide if on-site training needs to be scheduled.

PS

Download ROSA plan from SMS onto USB drive for the surgery

PDM/REC

3

6

7

8

9

Complete

Action Item

REC: Zimmer Biomet Reconstructive Sales Representative • PS: Personalised Solutions • PDM: ROSA Program Development Manager

7 | ROSA Knee System

Due Date

Owner

CENTRAL STERILE SERVICES DEPARTMENT (CSSD) IN-SERVICE TRAINING Central Sterile Services in-service training will take place on the same day as the OR staff in-service training. Multiple CSSD in-services can be carried out during the launch event to cover all shifts if needed. Please work with the local Zimmer Biomet representative to schedule. • The ROSA CSSD in-service will cover: − Review instrument trays − Cleaning and assembly / disassembly requirements for robotic instruments − Review sterilisation protocol and cleaners • Laminated pictures of the ROSA Tray with instrument details will be provided.

8 | ROSA Knee System

SURGEON CREDENTIALING ROSA Knee Medical Education Program At the centre of every successful ROSA program launch is an appropriately equipped surgeon. The ROSA Medical Education program prepares each surgeon for clinical procedures through required participation in didactic and hands-on cadaveric based experiences centred around the following focus areas: • Analog vs. Digital - Instrumented techniques compared to digital technology • X-Atlas 2D to 3D X-Ray Protocol and Process • Pre-operative Planning • ROSA Set-up – Preferences, Positioning, Draping, Calibration and Arm Registration • NavitrackER® Placement – Pin Positioning for Array Visibility • Landmark Registration – Importance of Landmarks, Locations and Troubleshooting • ROSA Surgical Planning – Knee State Evaluation, Balance Tool and Resection Planning • ROSA Resections – Cut Block Selection and Attachment, Arm Movements and Modes, Resection Selections and Validation, Femoral Rotation Tool • Adapting ROSA to Surgeon Workflow

Resources There are many additional resources for you to support the use and implementation of the ROSA Knee System, including an onboarding kit with documentation, videos and more. Please contact your Zimmer Biomet Representative for this information.

Unlike advanced robotic applications used in general surgery applications, ROSA does not represent a new knee procedure. It is an enabling technology that adapts to each surgeon’s work flow. Performing multiple cases on a surgical day soon after completion of certification training is advisable to shorten the adoption curve for each surgeon, the surgeon’s team and to elevate the use of ROSA to routine.

9 | ROSA Knee System

ROSA KNEE UNIT INSTRUMENTS V1.2 Product

Component’s Name

Part Number

20-8020-007-00

ROSA Arm Reference Frame

20-8020-015-00

ROSA Persona TKA Cut Guide B

20-8020-008-00

ROSA Knee Persona ID Plate (must order two)

20-8020-060-01

ROSA NexGen® TKA Cut Guide A

20-8020-009-00

ROSA Knee NexGen ID Plate (must order two)

20-8020-061-01

ROSA NexGen TKA Cut Guide B

20-8020-010-00

ROSA Knee Vanguard ID Plate (must order two)

20-8020-062-01

ROSA Vanguard® TKA Cut Guide A 20-8020-011-00

ROSA Knee Instrument Case

20-8020-063-00

ROSA Vanguard TKA Cut Guide B

20-8020-012-00

ROSA Knee Tray

20-8020-064-00

ROSA Registration Pointer

20-8020-013-00

Instrument Case Lid

110031221

Component’s Name

Part Number

ROSA Persona® TKA Cut Guide A

Product

11 | ROSA Knee System

ROSA KNEE UNIT INSTRUMENTS V1.2 Disposables for Pinning Cut Guides

X-Atlas Imaging Instrumentation Product

Component’s Name

Part Number

X-PSI™ Calibration Kit

20-8085-020-00

Product

Component’s Name

Qty

Part Number

Headless Trocar Drill Pin 75mm

4

00-5901-020-00

CAS 3.2 mm Headless Trocar 1 Drill Pin

20-8000-000-16

Vanguard Quick Release Trocular Pin

2

32-486255

Vanguard Sterile Quick Release Drill Pin

2

32-486265

Disposables Product

Component’s Name

Qty

Part Number

Fix Fluted Pin 3.2x150mm (non-sterile)

1

20-8000-000-01

Fix Fluted Pin 3.2x80mm (non-sterile)

1

Fix Fluted Pin 3.2x150mm

2

Fix Fluted Pin 3.2x80mm*

20-8000-000-02

Other Disposables

2

20-8000-000-10

Product

Component’s Name

Part Number

NavitrackER Kit A: Knee

20-8000-000-07

ROSA Robotic Unit Drape - Box 20

20-8020-080-00

Monitor Drape - Box 20

ROSAS00056

20-8000-000-11

1 ROSA consumables Single Use Instrument Kit is opened per case. This includes: 2 x2 fluted pins packs, 4 trocar pins, NavitrackERs, 2 drapes (robotic unit, monitor), Kit A - 80mm pins (item code TPAU-ROSAKT80) Kit B 150mm pins (item code TPAU-ROSAKT150) *

12 | ROSA Knee System

INSTRUMENT SETS

Instrument Sets Component’s Name

Part Number

Qty

Component’s Name

Part Number

Qty

Universal Validation Tool Body

20800001006

1

ROSA Registration Pointer

20802001300

1

Distal & Posterior Condyles Digitiser

20800001017

1

ROSA Arm Reference Frame

20802001500

1

Femoral Reference Frame

20800001033

1

3.5mm Hex Head Screwdriver

00-5120-087-00

1

ROSA Tibia Reference A

20802002800

1

ROSA Knee Persona ID Plate

20-8020-060-01

2

ROSA Tibia Reference B

20802002900

1

Lid

110031221

1

NavitrackER Pliers

20800007005

1

ROSA Knee Instrument Case

20-8020-063-00

1

ROSA Base Reference Frame

20802000200

1

ROSA Knee Tray

20-8020-064-00

1

ROSA Arm Instrument Interface

20802000400

1

ROSA Persona TKA Cut Guide A

20802000700

1

ROSA Persona TKA Cut Guide B

20802000800

1

13 | ROSA Knee System

INSTRUMENT SETS

Instrument Sets Component’s Name

Part Number

Qty

Component’s Name

Part Number

Qty

Universal Validation Tool Body

20800001006

1

ROSA Registration Pointer

20802001300

1

Distal & Posterior Condyles Digitiser

20800001017

1

ROSA Arm Reference Frame

20802001500

1

Femoral Reference Frame

20800001033

1

3.5mm Hex Head Screwdriver

00-5120-087-00

1

ROSA Tibia Reference A

20802002800

1

ROSA Knee NexGen ID Plate

20-8020-061-01

2

ROSA Tibia Reference B

20802002900

1

Lid

110031221

1

NavitrackER Pliers

20800007005

1

ROSA Knee Inst. Case

20-8020-063-00

1

ROSA Base Reference Frame

20802000200

1

ROSA Knee Tray

20-8020-064-00

1

ROSA Arm Instrument Interface

20802000400

1

ROSA NexGen TKA Cut Guide A

20802000900

1

ROSA NexGen TKA Cut Guide B

20802001000

1

14 | ROSA Knee System

INSTRUMENT SETS

Instrument Sets Component’s Name

Part Number

Qty

Component’s Name

Part Number

Qty

Universal Validation Tool Body

20800001006

1

ROSA Registration Pointer

20802001300

1

Distal & Posterior Condyles Digitiser

20800001017

1

ROSA Arm Reference Frame

20802001500

1

Femoral Reference Frame

20800001033

1

3.5mm Hex Head Screwdriver

00-5120-087-00

1

ROSA Tibia Reference A

20802002800

1

ROSA Knee Vanguard ID Plate

20-8020-062-01

2

ROSA Tibia Reference B

20802002900

1

Lid

110031221

1

NavitrackER Pliers

20800007005

1

ROSA Knee Inst. Case

20-8020-063-00

1

ROSA Base Reference Frame

20802000200

1

ROSA Knee Tray

20-8020-064-00

1

ROSA Arm Instrument Interface

20802000400

1

ROSA Vanguard TKA Cut Guide A

20802001100

1

ROSA Vanguard TKA Cut Guide B

20802001200

1

15 | ROSA Knee System

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