VELYS Robotic-Assisted System User Guide Ver 1.6 Rev J

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

1.0 Introduction 1.0

General Information

1.0–Introduction 2.0 System Overview 1.1

Key Surgical Steps Summary

General Information

8 9 9 11 12

Method of Operation Key Features Hardware Components Overview Software Interface Overview VELYS™ Robotic-Assisted Solution Application for Total Knee – Flowchart Compatibility with Medical Device

13 3.0

9.0

4

Technical Characteristics 14 16 17 17 18

23 23 24

System Information System Specification Detachable Parts Accessories Operating, Storage and Transportation Environment Electromagnetic Emissions Electromagnetic Immunity Proximity to System and Radio Frequency Communications Equipment: IEC 60601-1-2 Test Levels Electrical Shock Protection Electromagnetic Disturbances External Connections

19 20 22

4.0

Warning for Use

25

Warning for Use

5.0

Base Station

26 28 28

Description Surgical Procedure Use Transport and Storage

6.0

Satellite Station

29 30 31

Description Surgical Procedure Use Processing, Transport and Storage

7.0

Robotic-Assisted Device Assembly

32 33 37 40 41

Description Robotic-Assisted Device Holding Arm Robotic-Assisted Device Assembly Draping Transport and Storage

42 43 43

Description Saw Assembly Duty Cycle

Instrumentation

46

46 49 51 10.0 Application User Interface 53 57 59

Saw Handpiece

59 Surgeon Account

61 62 64

Create Account Edit Account Export Case Report

12.0 Administrator Account

65

Administrator Account

13.0 System Setup

68 69 72 73

96

System Setup Setup Summary System Positioning in OR Cable Connections for the System System Start-up System Connections Surgeon Account Selection Patient Information Entry Robotic-Assisted Device Initialization Saw Assembly and Pointer Check Saw Blade Calibration System Draping Device Array Assembly with the Device Array Interface Saw Mounting on the Saw Interface Robotic-Assisted Device Check Robotic-Assisted Device Transfer to the Bedrail Setup Completion

98 99 99

Introduction Pre-Operative Setup Checklist Surgical Profile Selection

11.0

74 75 75 76 76 77 79 80 89 89 90 93

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Reusable Instruments – System-Specific Reusable Instruments – ATTUNE™ and INTUITION™ CAS Ligament Tensor Kit Single-Use Sterile Instruments Instrument Trays Assemble Array to Clamp Graphical User Interface Navigation Volume, Brightness and Time Zone Settings Pop-ups

14.0 Intraoperative Use 8.0

44

2

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101 101 102 105 107 108 115 118 122 123 126 134 135 137 137

Surgical Profile Values Bone Checkpoints Creation Bone Arrays Setup Camera Adjustment Bone Checkpoints Acquisition Landmarks Acquisition Initial Leg Alignment and ACCUBALANCE™ Graph Recording PROADJUST™ Surgical Planning Femur Checkpoint Verification Robotic-Assisted Device Positioning Performing Resections Leg Alignment and ACCUBALANCE™ Graph Recording with Trial Implants Recuts (If Necessary) Balance After Insertion of Final Implants (Optional) Export Case Report

15.0 System Tear-Down

139 Robotic-Assisted Device Removal 142 Single-Use Instruments Disposal 144 Drape Disposal 146 Preparation of Reusable Instruments for Processing 147 Preparation of Saw Handpiece for Processing 148 System Shutdown

16.0 Processing – Stations and Robotic-Assisted Device Assembly

149 Processing – Stations and Robotic-Assisted Device Assembly 150 Satellite Station and Robotic-Assisted Device Assembly Processing 151 Base Station Processing

17.0

Storage and Transport

18.0 Service and Maintenance 155 General Information 156 System Components Disposal 156 Contact Information 19.0 Cybersecurity

157

20.0 Glossary

159 TKA: Total Knee Arthroplasty

21.0 Appendix 1: System Troubleshooting

160 163 168 179

Cybersecurity

General Troubleshooting Information General System Issues Pre-Op Troubleshooting Intra-Op Troubleshooting

22.0 Appendix 2: 196 Drill Preparation Drill Preparation for Array Drill Pin Insertion 23.0 Appendix 3: Processing – Reusable Instrumentation

197 198 198 200 200 202

Instructions Introduction Warnings and Cautions Limitations on Processing Processing Workflow Point of Use Care, Containment and Transportation, Preparation Before Cleaning for All Reusable Instruments 203 Saw Handpiece Cleaning, Thermal Disinfection and Drying 205 System-Specific Instruments Cleaning, Thermal Disinfection and Drying 208 Maintenance and Inspection, Packaging, Sterilization and Storage of All Reusable Instruments 211 Additional Information

24.0 Appendix 4: 212 Disassembly Instructions Disassembly Instructions

152 System-Specific Reusable Instruments 153 Base Station, Satellite Station and Robotic-Assisted Device Assembly

25.0 Appendix 5: Staff Positioning and Retractors

Page 3 of 217

214 Staff Positioning and Retractors

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VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

1.0 General Information

General Information

The VELYS™ Robotic-Assisted Solution User Guide is the approved reference document for use of the VELYS™ Robotic-Assisted Solution. These Instructions for Use include detailed instructions and additional user information and should be referenced during the use of the VELYS™ Robotic-Assisted Solution.

Purpose

4

This manual provides comprehensive information on the system functions and components. It details the instructions for setting up, using, transporting, processing, and storing the VELYS™ Robotic-Assisted Solution.

Manufacturer

This VELYS™ Robotic-Assisted Solution User Guide is meant for use with Software Version 1.6. Information about which version of the Software is installed on the system is available via the Home Screen. Tap on the “Toolbox” button and select “System Information”. The Software Version installed on the system is indicated by the first two digits in the “clinicalapplication” number (e.g. 1.6).

DePuy Ireland UC Loughbeg, Ringaskiddy Co. Cork, Ireland

General Information This manual provides information about the VELYS™ Robotic-Assisted Solution only and is not intended to serve as medical advice. Further, the information contained herein does not recommend or otherwise suggest the use of a particular procedure, product or surgical technique. It is the treating physician’s responsibility, not the responsibility of DePuy Synthes, to select the appropriate procedure, product or sterile technique for his or her patients. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Patents Reference: US Patents www.depuysynthes.com/patentmarking

Indications for Use The VELYS™ Robotic-Assisted Solution is intended for stereotaxic surgery to help the surgeon to identify the relative position and orientation of anatomical structures, plan the position of the femoral and tibial implant components intraoperatively, and prepare the bones during total knee arthroplasty. The VELYS™ Robotic-Assisted Solution is indicated for use with the ATTUNE™ Total Knee System and its cleared indications for use.

Page 4 of 217

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1.0

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

General Information

5

General Information Implant Compatibility

Patients with insufficient bone density to support the array pins and implants should not be treated using the VELYS™ Robotic-Assisted Solution.

The VELYS™ Robotic-Assisted Solution is compatible with the following implant systems for the indication of a Primary Total Knee Arthroplasty only: ATTUNE™ Total Knee System: – ATTUNE™ Femoral Components CR/PS Cemented – ATTUNE™ Femoral Components CR/PS Cementless – ATTUNE™ Tibial Inserts CR/PS FB – ATTUNE™ Tibial Inserts CR/PS RP – ATTUNE™ Tibial Inserts Medial Stabilized FB – ATTUNE™ Tibial Bases FB/RP Cemented – ATTUNE™ Tibial Bases FB/RP Cemented S+ – ATTUNE™ Tibial Bases FB/RP Cementless – ATTUNE™ Revision Tibial Bases Fixed Bearing, which may be used in combination with 14 mm x 30 mm and 14 mm x 50 mm ATTUNE™ Revision Cemented Stems* – ATTUNE™ Revision Tibial Bases Rotating Platform, which may be used in combination with 14 mm x 30 mm ATTUNE™ Revision Cemented Stem* – ATTUNE™ Tibial Bases CR/PS ALL POLY* – ATTUNE™ Medialized Dome/Anatomic Patella

Environment of Use

* All Poly and Revision tibial bases used with cemented stems are not recommended with patient specific alignment techniques

The following list describes symbols used throughout this document and their meanings.

The VELYS™ Robotic-Assisted Solution is intended for use in operating rooms within hospitals, private clinics, outpatient surgical centers and other clinical environments.

A full set of manual instruments should be available to permit the completion of manual implantation of ATTUNE™ implants in case VELYS™ Robotic-Assisted Solution cannot be used to complete the case.

Copyright and Trademark © DePuy Synthes 2020. All rights reserved. DEPUY SYNTHES, VELYS™ and ATTUNE™ are trademarks of DePuy Synthes.

User Guide Symbols

This list represents the final implant constructs permitted for use with the VELYS™ Robotic-Assisted Solution, though additional preparation may be required.

Warning boxes indicate instructions to follow to avoid potential serious injury to the patient/user or system malfunctions which may lead to serious injury to the patient/user.

Additional ATTUNE™ Knee System Components may have been cleared for use with the VELYS™ Robotic-Assisted Solution since the last publication of this IFU.

Caution boxes indicate instructions to follow to avoid a potentially hazardous situation which may lead to a minor patient/user injury or damage of the system.

Contraindications In addition to contraindications specified by the ATTUNE™ Total Knee System implant system used by the surgeon, contraindications for using VELYS™ Robotic-Assisted Solution for certain patient populations are as follows: – –

Patients for whom a hip center of rotation cannot be established using the VELYS™ Robotic-Assisted acquisition protocols Patients in whom the necessary bony landmarks needed for acquisition are not present or accessible

Note boxes indicate useful information for the user to increase workflow efficiency.

Page 5 of 217

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1.0

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

General Information

6

General Information Product Labelling

Symbol

Description

Symbol

Description

Symbol

Description

Caution

Use-by Date

ETL Listed Mark

Consult Instructions for Use

Do Not Use if Package is Damaged

Regulatory Compliance Mark

Follow Instructions for Use

Do Not Re-Use

Separate Collection

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician

Do Not Resterilize

Temperature Limit

Serial Number

Sterilized Using Irradiation

Humidity Limit

Batch Number

Sterilized Using Ethylene Oxide

European Conformity

Non-Sterile

UK Conformity Assessed

Keep Dry

UK Responsible Person

Mass of Mounted Part

Unique Device Identifier

Country of Manufacturing

Equipotentiality

Maximum Total Loading

Manufacturer

Protective Earth (Ground)

Contains Hazardous Substance

Date of Manufacture

Type B Applied Part

Catalogue Number

NON STERILE

Quantity

Medical Device

= kg

Page 6 of 217

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1.0

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

General Information

7

General Information Available Documentation

Name

Read all documentation carefully. Refer to these documents when operating the VELYS™ Robotic-Assisted Solution. The information contained in these documents is based on the most current information available at the time of printing. Figures are representative.

VELYS™ Satellite Station Sterile Drape IFU

Description –

Instructions for Use of the VELYS™ Robotic-Assisted Solution

ATTUNE™ Primary Knee System INTUITION™ Instruments Surgical Technique

–

Comprehensive information on system functions and components

System Installation

–

Overview of treatment planning and image-less navigation

–

Guidelines for the implantation of the ATTUNE™ Primary Knee System using the VELYS™ Robotic-Assisted Solution

–

Follows a “Femur First” workflow

–

Guidelines for the implantation of the ATTUNE™ Primary Knee System using the VELYS™ Robotic-Assisted Solution

–

Follows a “Tibia First” workflow

VELYS™ Robotic-Assisted Solution for Total Knee Surgical Technique Femur First Approach

VELYS™ Robotic-Assisted Solution for Total Knee Surgical Technique Tibia First Approach

Guidelines for the implantation of the ATTUNE™ Primary Knee System using the VELYS™ Robotic-Assisted Solution

–

Follows a “Hybrid” workflow

–

Instructions for Use of the Robotic-Assisted Device Sterile Drape Legal manufacturer: Microtek Medical, Inc.)

–

Instructions for Use of the Satellite Station Sterile Drape Legal manufacturer: Microtek Medical, Inc.)

–

Guidelines for the manual implantation of ATTUNE™ Knee System Family of Knee Implants with the INTUITION™ Instrumentation

VELYS™ Device Sterile Drape IFU

VELYS™ Robotic-Assisted Solution Documentation

VELYS™ Robotic-Assisted Solution for Total Knee User Guide

– VELYS™ Robotic-Assisted Solution for Total Knee Surgical Technique, Hybrid Approach

It is important to review these documents thoroughly before operating the VELYS™ Robotic-Assisted Solution. Additional information, training, and product servicing are available from DePuy Synthes. When using VELYS™ Robotic-Assisted Solution accessories, please refer to the appropriate Instructions for Use (IFUs).

Name

Description

DO NOT use the VELYS™ Robotic-Assisted Solution prior to a proper installation and system check by authorized DePuy Synthes personnel. Only authorized DePuy Synthes personnel should assemble, install, maintain and service the VELYS™ Robotic-Assisted Solution. Contact your DePuy Synthes VELYS™ representative. Refer to Chapter 18, “Service and Maintenance” for contact information.

Page 7 of 217

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VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

2.0 System Overview

8

Method of Operation The VELYS™ Robotic-Assisted Solution is a robotic-assisted surgery solution for Total Knee Arthroplasty (TKA). It uses established surgical navigation principles with an infrared Camera to track system components and patient bones in real-time. The system assists the surgeon in assessing the anatomy of the patient’s knee, planning the position of the implant components intraoperatively, and preparing the bones. The system guides the surgeon through intraoperative acquisition of bony landmarks and generates a surgical plan based on the surgeon’s preferences, without requiring pre-operative CT scans. The surgeon can perform real-time kinematic measurements and adjust the proposed position of the implant, if desired. After the surgeon validates the surgical plan, the system positions the Robotic-Assisted Device at the defined cutting plane for each resection and maintains the blade of the surgical Saw within the plane, while tracking and responding to patient movement. The system allows the surgeon to actuate and manipulate the surgical Saw within the defined planes.

Page 8 of 217

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2.0

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

System Overview

Key Features

9

Hardware Components Overview Main Components The main components of the VELYS™ Robotic-Assisted Solution are shown below. The system is presented in an operating room, prepared for a TKA surgery on the right leg.

The VELYS™ Robotic-Assisted Solution is an imageless Robotic-Assisted surgery solution for Total Knee Arthroplasty to aid the surgeon in the following steps: Assessing patient anatomy –

The assessment is performed intraoperatively without the need for pre-operative CT scans

–

The patient’s femur and tibia are localized based on navigation Arrays fixed to the bones and bony landmarks that the surgeon identifies using a Pointer Array

–

5 6 1 3

The kinematic measurements (including limb alignment, knee range of motion, and laxity) are evaluated in real-time

2

Planning position of implant components –

The surgical plan is generated intraoperatively, based on the surgeon’s defined preferences

–

The surgeon can interactively adjust the proposed plan, including the implant size and position

4

Preparing the bones –

The Robotic-Assisted Device positions and maintains the Saw Blade within defined cutting planes by tracking a navigation array on the Saw

–

The surgeon actuates and manipulates the Saw while the Robotic-Assisted Device constrains the position of the Saw Blade inside the defined cutting plane

–

The system prevents actuation of the Saw if the Saw Blade is outside the defined cutting plane

1. Base Station

2. Satellite Station

3. Robotic-Assisted Device

4. Holding Arm

5. Instrumentation

6. Saw Handpiece

Functional Use The main function of the Robotic-Assisted Device is to maintain the Saw Blade within the planned resection planes. To accomplish this, the system functions as summarized below. Throughout the procedure, the surgeon and/or clinical staff navigate through the surgical workflow using the Footswitch or the Touchscreens on the Base and Satellite Stations. The Holding Arm enables the draped Robotic-Assisted Device to be fixed to the OR bedrail on the operative knee side for resections. Once positioned on the bedrail, the Holding Arm is used to adjust the position of the Robotic-Assisted Device.

Page 9 of 217

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2.0

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

System Overview

10

Hardware Components Overview Functional Use The Saw is attached to the Planar Articulation of the draped Robotic-Assisted Device via the sterile Saw Interface.

4 1

The surgeon presses the Footswitch to control the movement of the motorized Robotic-Assisted Device and positions the Saw in each resection plane. During a resection step, the surgeon releases the Planar Articulation, makes the Saw visible to the Camera on the Base Station and actuates the Saw to complete the planned resection. The Planar articulation enables the NATURAL CONTROL™ Technology which provides free movement of the Saw within the resection plane. This plane is set using the ADAPTIVE TRACKING™ Technology, where the Robotic-Assisted Device adjusts and controls the plane using the position of the PURESIGHT™ Reflectors tracked by the Camera.

5

2

3

6 7

The required PURESIGHT™ Reflectors must remain visible to the Camera. –

–

Any debris (blood or tissue) on the Reflectors obscure their visibility to the Camera. Minimize touching the Reflectors directly and wipe any debris from them. Maintain a clear line of sight between the Arrays and the Camera.

In the event of system failure, the user can complete the case using manual instruments.

1. Saw held by the Surgeon

2. Saw Blade maintained within planned resection plane

3. Bone Array continuously tracked to adjust blade position

4. Planar Articulation released by the Surgeon

5. Robotic-Assisted Device adjusting Saw position

6. Extended and secured Holding Arm

7. Holding Arm clamped on bedrail at hip center

The figures in this guide represent the system components to aid in understanding the components and steps. Nevertheless, the figures should always be used in conjunction with the written instructions. The Robotic-Assisted Device should always be draped for resection and before transfer onto the bedrail, even if some figures present the Robotic-Assisted Device not draped so that components can be identified.

Page 10 of 217

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2.0

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

System Overview

11

Software Interface Overview The system follows a predefined surgical workflow that includes the following steps:

This section outlines the key functions of the VELYS™ Robotic-Assisted Solution Application for Total Knee. From the Home screen, the surgeon or clinical staff can begin a procedure or access system and account settings. Surgical procedures can only be initiated from the Home screen. General system settings and account settings are only accessible from the Home screen, before or after a surgical procedure, but not while the surgical procedure is in-progress.

–

System setup

–

Creating or selecting a surgical profile

–

Acquisition of the bony landmarks

–

Initial leg alignment and gap assessment

–

Surgical planning

–

Robotic resections (order varies based on selection of surgical procedure)

–

Final alignment and gap assessment

1a 1b

2

1. Select and start a surgical workflow: 1a: TKA Femur First 1b: TKA Tibia First

2. Account Management for: - Surgeons - Accounts administrators - Service

3

4

3. System Settings: - Display settings - System information

4. Shut Down System

Page 11 of 217

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2.0

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

System Overview

12

VELYS™ Robotic-Assisted Solution Application for Total Knee – Flowchart Home

Setup

Workflow selection – (e.g., Femur First, Tibia First) – Account settings – System settings – Shut down

Operative Knee Side selection (Workflow is updated to reflect the selected operative leg) – Gender specification

Components connection

Intraoperative

–

– – – – –

Intraoperative

– –

Camera positioning Checkpoint and Landmarks acquisition

–

Robotic-Assisted Device initialization Pointer check Saw Blade calibration System draping Robotic-Assisted Device check

End of Procedure

Initial Leg Alignment and ACCUBALANCE™ Graph Recording – PROADJUST™ Surgical Planning – Resections (Order varies based on selected workflow)

– –

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Leg Alignment and ACCUBALANCE™ Graph Recording Recuts (Optional)

–

Export Case Report

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2.0

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

System Overview

13

Compatibility with Medical Device D40

66.40

.90

D37

Using equipment not specified in this manual with the system may result in malfunctions, leading to patient/user injury.

.00

22.25

Only use instruments specified by DePuy Synthes. Using unauthorized instruments may adversely affect safety and/or effectiveness of the system.

47.40

Hardware Symbols

Symbol

Description

Symbol

62.40

Description

Direction for Unfolding Satellite Sterile Station Drape and Device Sterile Drape

22.20

Consult Instructions for Use .90

IPX4

66.40

Batch Number

Do Not Submerge

Indicator for Hand Placement During Robotic-Assisted Device Draping

43.40

White “Tear Here” Label D40

.90

D37

.00

Direction of the Camera Relative to the Array Clamp

Blue “Tear Here” Label

S9

47.40 LEFT/RIGHT KNEE

Protected Against Splashing Water Duty Cycle Type According to IEC 60034-1.

Knee Side Indicator 66.40

Detailed Information Available in the “Duty Cycle” Section of Chapter 8, “Saw Handpiece”.

0

0.9

D4

Open Lock Orientation Cue

Type B Applied Part

62.40

22.25

Robotic-Assisted Device Cable Connector Location

47.40

Station Cable Connector Location

43.40

Orientation Indicator for Robotic-Assisted Device Draping 22.20

VELYS™ Logo 47.40

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STOP

Emergency Stop

62.40

22.25

Starting Position Indicator for Satellite Station Draping

Do Not Push

Saw Power Cable Connector Location 66.40

22.20

D37

Saw Assembly with Saw Interface Cue

.00

Dismantle for Cleaning

Description Separate Collection

D40

Do Not Re-Use

22.25

Symbol

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VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

14

3.0 Technical Characteristics

System Information

The technical characteristics of the VELYS™ Robotic-Assisted Solution, including software, main components, detachable parts and accessories, are described in this chapter.

For access to the System Information screen, tap on the “Toolbox” button from the Home Screen then tap on “System Information” (B).

(A)

The Home Screen is the main page of the system, displayed prior to the selection of a surgical workflow or when the surgical procedure is completed and exited.

B A

The System Information screen enables access to software version, case logs export and system data export.

1

2

1. Software Version

2. Case Count Logs to USB

3

3. System Data to Network

Software Version The version of the software installed on the system is listed on the System Information screen (1). Refer to the first two digits in the “clinical-application” number (e.g. 1.6).

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VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

3.0 Technical Characteristics

15

3.0 Technical System Information Characteristics The technical characteristics of USB the VELYS™ Robotic-Assisted Solution, Case Count Logs Export to including software, main components, detachable parts and accessories, The Case Count Logs file contains information about the number of cases are described in this chapter. performed on the system as well as date and case ID. Case Count Logs can be exported from the System Information screen. For exporting Case Count Logs to USB, insert a USB flash drive, then tap on the “Case Logs to USB” button (2).

System Data Export to Network The System data contain Saw Handpiece logs and Case Count Logs described above. For exporting System data to network, connect the system to the network then tap on the “Transmit Data to Network” button (3). Refer to the “External Connections” section for more information on the connection. Note that the export may take up to an hour depending of the size of the data.

The case reports cannot be exported from the System Information screen. Refer to the “Export Case Report” section in Chapter 11 for information on case report export.

Page 15 of 217

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VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

3.0 Technical Characteristics

16

System Specification Table 1: Main components of the VELYS™ Robotic-Assisted Solution – Technical Characteristics

Base Station

Satellite Station

Robotic-Assisted Device

Holding Arm

Saw Handpiece

Weight

~92 kg (~203 lb)

~89 kg (~196 lb)

~7 kg (~15 lb)

~11 kg (~24 lb)

~1.7 kg (~3.7 lb)

Power Requirements

100-240V~ 12-6A 50-60Hz

N/A

N/A

N/A

N/A

Electrical Safety

IEC 60601-1

IEC 60601-1

IEC 60601-1

N/A

IEC 60601-1

IP Classification

IPXX, Except for the Footswitch: IPX8

IPXX

IPXX

N/A

IPX4

Materials

Aluminum/Steel/ Stainless Steel/ Elastomer/Plastic/ Polyester/Urethane

Aluminum/Steel/ Stainless Steel/ Elastomer/Plastic/ Polyester/Urethane

Aluminum/Titanium/ Stainless Steel/ Plastic/Silicon

Aluminum/ Stainless Steel/ Titanium/Plastic

Aluminum/Stainless Steel/Silicon

Sterility Status

Non-Sterile (Use Out of Sterile Field)

Non-Sterile (Use of Sterile Cover)

Non-Sterile (Use of Sterile Cover)

Non-Sterile (Use of Sterile Cover)

Non-Sterile (To be Sterilized)

Mode of Operation

Continuous

Continuous

Continuous

N/A

Non-Continuous

Duty Cycle

N/A

N/A

N/A

N/A

8 Cycles of: 30s on/10s off

Cool Down Time After Case Completion

N/A

N/A

N/A

N/A

50 min

1800 Cases

300 Cases

200 Cases* (per Handpiece)

Reusable

Reusable

Reusable

Housing

Sterility and Usability

Service Intervals

Usability

300 Cases

Reusable

Reusable

* This assumes one reprocessing cycle per surgical procedure Additional technical descriptions can be found in the VELYS™ Robotic-Assisted Solution Install Manual and/or VELYS™ Robotic-Assisted Solution Maintenance Manual.

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3.0 Technical Characteristics

VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

Detachable Parts

Accessories

Cables

In addition to the main components and detachable parts described above;

The VELYS™ Robotic-Assisted Solution has to be used with the following cables provided:

–

All the instrumentation described in Chapter 9, “Instrumentation”, are available for use with the VELYS™ Robotic-Assisted Solution

–

Surgeon’s preferred leg holder and/or leg support may be used, if it does not inhibit the function of the VELYS™ Robotic-Assisted Solution

–

Surgeon’s preferred retractors must be used during the resection to protect the soft tissues from damage by the Saw Blade

–

The VELYS™ Robotic-Assisted Solution is compatible with the implant systems listed in the “Implant Compatibility” section of the Chapter 1, “General Information.”

Technical Description

Length (m)

Shielding

Ferrites

Termination

Satellite Station Cable

6m (~19 ft. 8 in.)

Braid shield

None

Base Station

Base Station Power Cable

6.1 m (~20 ft.)

None

None

AC Source

17

Footswitch The Footswitch is provided with the Base Station and has to be connected to the back of the Base Station during the setup of the VELYS™ Robotic-Assisted Solution. Refer to Chapter 13, “System Setup” for detailed information on connections.

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VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

3.0 Technical Characteristics

18

Operating, Storage and Transportation Environment The conditions for operating and storing the system at the hospital are: Base Station

Satellite Station

Robotic-Assisted Device

Holding Arm

Temperature

15.5°C ≤ T ≤ 23.9°C (60°F ≤ T ≤ 75°F)

Relative Humidity

20% ≤ RH ≤ 60%

Atmospheric Pressure

70.5 kPA ≤ AP ≤ 103 kPA (~0.7 bar ≤ AP ≤ ~1.0bar)

Maximum Altitude

3000 m (~9843 ft)

Saw Handpiece

The conditions for transporting the system are: Base Station

Satellite Station

Robotic-Assisted Device

Temperature

-20°C ≤ T ≤ 50°C (-4°F ≤ T ≤ 122°F)

Relative Humidity

25% ≤ RH ≤ 90%

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Holding Arm

Saw Handpiece

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VELYS™ Robotic-Assisted Solution for Total Knee Surgical Technique - User Guide

3.0 Technical Characteristics

19

Electromagnetic Emissions The VELYS™ Robotic-Assisted Solution is CISPR 11 group 1, class A equipment.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The VELYS™ Robotic-Assisted Solution is intended for use in the electromagnetic environment below. Users should ensure that the system is used accordingly. Emissions Test

Compliance

RF Emissions CISPR 11

Group 1

RF Emissions CISPR 11

Class A

AC Mains Conducted Emissions CISPR11

Class A

Harmonic Emissions IEC 61000-3-2

Class A

Flicker Emissions IEC 61000-3-3

Complies

Electromagnetic Environment – Guidance The VELYS™ Robotic-Assisted Solution uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The VELYS™ Robotic-Assisted Solution is suitable for use in a Professional Healthcare Facility environment. NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Page 19 of 217

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VELYS™ Robotic-Assisted Solution for Total Knee - User Guide

3.0 Technical Characteristics

20

Electromagnetic Immunity

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The VELYS™ Robotic-Assisted Solution is intended for use in the electromagnetic environment below. Users should ensure that the system is used accordingly. Immunity Test Electro-Static Discharge IEC 61000-4-2 Radiated, Radio-Frequency, Electromagnetic IEC 61000-4-3 Proximity fields from RF wireless communications equipment IEC 61000-4-3

IEC 60601-1-2 Test Levela

Port

Compliance Level

Electromagnetic Environment – Guidance

±2,4,6,8 kV contact ±2,4,8,15 kV air

Enclosure

Complies

Floors should be wood, concrete, or ceramic tile. If floors are synthetic, then r/h should be at least 30%

Enclosure

Compliesb

10V/m 80MHz to 2700MHz 80 % AM at 1 kHz

See IEC 60601-1-2 clause 8.10 Table 9

0.5kV,1kV,2kV Electrical Fast Transient/ Burst IEC

-------------------------------

IEC 61000-4-4

0.25kV,0.5kV,1kV

Surges Line-to-ground IEC 61000-4-5

Communications device transmitters, antennas and cables should be located more than 30 cm away from VELYS™ Enclosure

Complies

AC Mains 100VAC 50Hz 230VAC 50Hz ----------------

100 kHz repetition frequency

Signal input/output parts

0.5kV,1kV,2kV

AC Mains

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Complies Mains power quality should be that of a typical commercial or hospital environment

Complies

This document is valid only on the date printed. If unsure of the print date, please reprint to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.