COVVI Nexus Manual 

Technical Manual THE NEXUS HAND

continue to create leading prosthetic designs. The human hand is amazing and the level of functionality which can be restored through prosthetics has historically been very low; but as engineers and designers we see this as a challenge to continuously improve our designs to meet the needs of users. COVVI started with a blank sheet of paper and a mission to address some of the most prevalent deficiencies of current prosthetic hands. Fast forward to present day and we now have the fastest, strongest, and best-looking prosthetic hand in the market. The COVVI Team

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 Introduction 06 1.1 What Defines Us? 06 1.2 The Path to the Nexus Hand 06 1.3 Engineering Behind Nexus 07 What’s Inside 10 2.1 The Hand Kit 10 2.2 The Hand Kit Part Numbers 11 2.3 The Advantage Kit 12 2.4 The Advantage Kit Part Numbers 13 Technical Information 14 3.1 Nexus Glove Overview 14 3.2 Nexus Hand Overview 15 The Nexus Hand 17 Environmental Conditions 18 Safety Guidelines 19 6.1 Abuse & Neglect 19 6.2 IP44 19 6.3 Harsh Chemicals/Abrasives 19 6.4 Operating a Vehicle 20 6.5 Firearms 20 6.6 Sporting Activities 20 6.7 Safety Precautions 21 The Nexus Hand Overview 22 7.1 Connecting/Disconnecting the Nexus Hand 22 7.2 E-Paper Screen 24 Why Nexus? 26 8.1 Passively Flexing Fingers and Thumb 26 8.2 Integrated Flex Wrist 27 8.3 Intuitive Thumb Control/Smart Switching 28 8.4 Water and Dust Resistant (IP44) 28 8.5 The Index Fingertip is Touch Screen Compatible 29 8.6 Remote Firmware Updates 29 8.7 Various Grip Switch Triggers 29 Grip Patterns 30 9.1 Opposed Grips 30 9.2 Non-opposed Grips 32 The Nexus Thumb 34 Contents

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Contents 11.0 12.0 13.0 14.0 15.0 16.0 17.0 18.0 19.0 20.0 The COVVI Power Supply 36 11.1 Contents 36 11.2 Warnings 39 11.3 Power Supply Overview 40 11.4 The Batteries 41 11.5 Activating the System 42 11.6 Changing the Display Mode 43 11.7 Charge Indication 44 11.8 Fitting the COVVI Power Supply 46 11.9 System Specification 48 11.10 System Compatibility 52 11.11 Battery Replacement 52 11.12 Maintenance 53 Component Compatibility 54 COVVI Go App 58 13.1 COVVI Go 58 13.2 Registration 59 13.3 Hand Selection 59 13.4 Input Settings 61 13.5 Setup Wizard 65 13.6 Sensor Interface Screen 65 13.7 Operating Modes 66 13.8 Grip Tables 68 13.9 Grip Switch Triggers 69 13.10 Additional Setup 72 13.11 Changes 75 13.12 Advanced Configuration 76 13.13 Config History 77 13.14 Report a Bug 77 13.15 Reset to Default 77 13.16 Remote Firmware Updates 78 13.17 Custom Firmware Update 79 Maintenance 80 Warranty 81 15.1 24-Month Manufacturer’s Warranty 81 15.2 Optional Extended Warranty of up to 36 Additional Months 82 Warranty Service and Repairs 83 16.1 Limited Liability 83 Returns 84 Disposal 85 Symbols Used 86 EU Declaration of Conformity 87

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 1.0 Introduction Our name was formulated to reflect our single driving intention to change multiple lives together forever through harnessing endless connections to make anything possible. With our name came our ‘delta’ logo, which also has meaningful origins as a symbol of change and doing things differently. 1.1 What Defines Us? COVVI is a portmanteau of the Latin ‘Coperor’ and ‘Vita’, translating as ‘working together’ and ‘life’. 1.2 The Path to the Nexus Hand The Nexus Hand was born from a genuine passion for prosthetics and helping others. Through 10 years of working in the industry alongside clinicians and listening to users we have developed a sincere appreciation for how difficult prosthetics are to use and how poor devices do not address or resolve this. After the initial excitement of a new device, these frustrations frequently result in the prosthetic device being rejected, which we see as a personal failure. In today’s world there are so many products and designs that we simply do not need, yet in the field of prosthetics so much is still to be done. As a team we could not envisage more rewarding work than developing a cutting-edge prosthetic hand that overcomes as many of these issues as possible, so we made it our absolute mission to do so. We truly want to reduce the restrictions and limitations prosthetic users face every day. We designed the Nexus Hand with your patient in the forefront of our minds and we want it to be an invaluable tool in their life. Our two main goals were to make it functional and robust and we are confident it not only enables the easy performance of daily tasks but can withstand anything life throws at it! We always aim to develop desirable products, which is why we use only the best materials and pride ourselves on our unrivalled industrial design. After years of hard work, drive, and passion it makes us immensely proud to see our design working as intended and actively simplifying people’s lives.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 1.0 Introduction 1.3 Engineering Behind Nexus Stainless Steel Finger Pivot E-Paper Screen High Impact Polymer Chassis Stainless Steel Knuckle Cast Aluminium Digit Components Stainless Steel Finger Link Stainless Steel Finger Chassis Machined Aluminium Wrist Housing High Chromium Steel Wrist Plate ESD Pathway Stainless Steel Thumb Pivot

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 1.0 Introduction Our hand size range is suitable for all adults and most adolescents. At COVVI, we started with the small Nexus Hand and built bigger. This ensured we did not compromise on any functionality across the size range where in the past engineers had always started big and tried to shrink their design down, which was challenging to do without losing some of the hand’s function. We are extremely proud of our compact design and cannot wait to see your patient bring it to life! Note: This infographic below should only be used as a guide. Please take measurements of hands from clinical data. Note: TASKA is owned by 5TH ELEMENT LIMITED, Bebionic is owned by Otto Bock HealthCare GmbH, i-Limb is owned by Touch Bionics Limited. i-Limb XS Bebionic Medium Nexus Small Bebionic Small Michelangelo Nexus Medium Nexus Large i-Limb Large TASKA (8¼”)

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 The Nexus Hand was designed to withstand the necessities of daily activities; however, it should not be subject to excessive force. Please refer to section 6.0 for more information on our safety guidelines. As seen in section 12.0, please note that the Nexus Hand is recommended with COVVI products. The Nexus Hand should only be fitted by a Certified Prosthetist. This symbol is used in instances to warn about hazardous or dangerous materials and/or objects and will be used throughout this document. We do not recommend the use of carbon fibre materials in a fabricated socket unless it is grounded to the carbon fibre lamination. CAUTION PRECAUTIONS FOR HANDLING ELECTROSTATIC SENSITIVE DEVICES. This product uses semiconductors that can be damaged by electrostatic discharge (ESD). The Nexus Glove can be removed, but no further disassembly can be done. All disassembly and/or repairs below this level can only be conducted by certified technicians with training from COVVI. Any disassembly performed by unauthorised personnel will not be covered under warranty. 1.0 Introduction

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 2.0 What’s Inside 2.1 The Hand Kit To remove the Nexus Hand from its packaging, first slide foam piece 1 vertically out of the box, then slide the rest of the foam pieces along into the gap left by foam piece 1. Lift the hand from the box by foam piece 2 and 5 and slide both off from the EQD and fingertips, respectively. To replace the Nexus Hand back into the box, follow the steps in reverse. Please take care with the orientation of the foam pieces. Right Knuckle Foam Order of Disassembly Removable Insert for Medium & Large Left 2 3 5 4 1

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 2.0 What’s Inside 2.2 The Hand Kit Part Numbers Example Part Numbers: CV1LSQBLCA21#### CV1 | L | S | Q | BL | CA | 21 | #### Fixed Part Numbers CV1 Product Code Q EQD BL Glove Colour (Black) 21 Year Manufactured #### 4 Digit Serial Number Customisable Part Numbers CA WH White CA Carbon Black RG Rose Gold TG Titan Grey Cover Colours S S Small M Medium L Large Size L L Left Hand R Right Hand Hand Type

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 CCOUP Coupling Piece CAXCOR Coaxial Core & CLAMRG-## Lamination Ring *These are located on the underside of the foam with the electrodes **COVPS-1600 Shown CEL-## 2x Electrodes COVSWC Wall Charger Gain Adjuster & CELCAB-### Electrode Cables* Control Panel Nexus Hand COVPS-1600 - Prismatic** COVPS-2600 - Cylindrical 2.0 What’s Inside 2.3 The Advantage Kit

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 2.0 What’s Inside 2.4 The Advantage Kit Part Numbers Example Part Numbers: AK140E316 AK1 | 40 | E | 3 | 16 Fixed Part Numbers AK1 Product Code Customisable Part Numbers Note: The Advantage Kit is only sold with a Nexus Hand. Note: CEL 60 designed for the following regions, use CEL 50 in all other regions. United States, Brazil, Canada, Colombia, Mexico, West Japan, Saudi Arabia, South Korea, Guyana, Haiti, American Samoa, Anguilla, Antigua and Barbuda, Aruba, Bahamas, Belize, Bermuda, British Virgin Islands, Cayman Islands, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, French Polynesia, Guam, Guatemala, Honduras, Micronesia, Montserrat, Nicaragua, Palau, Panama, Peru, Philippines, Puerto Rico, Saint Martin (French), Sint Maarten (Dutch), St. Kitts and Nevis, Suriname, Taiwan, Trinidad & Tobago, U.S. Virgin Islands, Venezuela, Liberia, North Korea 3 X 1000mm 6 600mm 3 300mm 1 100mm Cable 40 40 40mm 45 45mm 50 50mm Wrist Size E U CEL-60 E CEL-50 Electrode Filter 16 16 COVPS-1600 26 COVPS-2600 Battery

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 3.0 Technical Information Flexible Glove EQD - Electric Quick Disconnect Palm Grip Surface E-Paper Screen Rigid Covers Dorsal Button Wrist Lock Button 3.1 Nexus Glove Overview

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 3.0 Technical Information Dimensions Small Medium Large Key Inches mm Inches mm Inches mm Middle Fingertip to Hand Base A 6.61 165 7.25 184 7.75 196 Thumb Tip to Hand Base B 4.46 110 4.5 114.5 4.8 124 Max Chassis Width C 2.76 70 3 75 3.1 80 Diameter of Chassis at Wrist D 1.85 47 1.85 47 1.9 50 Palm Circumference G 7.3 190 7.6 195 7.8 200 Maximum Opening Width - Tripod Grip H 4.4 110 4.4 115 4.8 120 Thumb Swing Through Angle 81° 81° 81° 81° 81° 81° Middle Fingertip to Flex Axis E 6.2 158 6.8 175 7.4 187 Thumb Tip to Flex Axis F 4 102 4.1 103.5 4.4 113 EQD Only X 0.98 3 0.98 3 0.98 3 Wrist Flexion Axis 3.2 Nexus Hand Overview C G A B E H F D X

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Maximum Hand Load Limit (A) with force applied upwards 90 kg / 198 lbs over the knuckles Maximum Hand Load Limit (B) picking weight up 32 kg / 70.5 lbs Avoid pressure on thumb 3.0 Technical Information Nexus Hand Voltage 7 to 8.4V Maximum Current Consumption 5A Device Weight 0.57kg / 1.25 lbs Maximum Hand Load Limit (A) 90kg / 198 lbs across knuckle Maximum Finger Load Limit 16kg / 35 lbs Full Open to Full Close 0.7 seconds to achieve grip Tripod Grip 0.4 seconds to achieve grip Tripod Grip Force 45N / 10 lbf Power Grip Force 80N / 18 lbf Key Grip Force 22N / 5 lbf

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 4.0 The Nexus Hand Prosthetic devices are very personal, the hand especially as it is always on show. We tirelessly reviewed current technology and always came back to the same conclusion: there is a big compromise between looks and function when it comes to a hand cosmesis. High-definition cosmetic gloves look very lifelike, but they are extremely expensive and limit hand dexterity. As the gloves get thinner, the function improves, but the realism decreases, ultimately negating the purpose of a cosmetic glove. With the Nexus Hand we went down a radical route to design something that users can customise in a way that speaks to their personality. Something that is undeniably them. We designed the Nexus Hand based on measured data collated from human hands to give it a more anatomically proportionate and natural form with novel colours and materials to create a concept that users will be proud to wear. We offer a black glove with four striking cover colours for them to choose from: Rose Gold Carbon Black Grey Titan White

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Maximum Temperature 104°F / 40°C Minimum Temperature -4°F / -20°C Humidity Maximum 80%, non-condensing Pressure 101.3kPa / 14.7psi The Nexus Hand is to be used exclusively for prosthetic fittings of upper limbs. Based on the environmental conditions below, the user should not use, transport, or store the Nexus Hand outside of the boundaries listed below. 5.0 Environmental Conditions

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 6.1 Abuse & Neglect We designed the Nexus Hand to be robust, but it still cannot withstand intentional abuse. The Nexus Hand cannot sustain excessive impacts or excessive water damage. 6.3 Harsh Chemicals/Abrasives The Nexus Hand is made up of a variety of materials which may be vulnerable to damage by various chemicals, such as solvents, acids, alkalis, corrosive substances, detergents, and similar chemicals. Please avoid exposing the Nexus Hand to any harsh chemicals that may cause damage. If your patient chooses to clean their Nexus Hand, please ensure they use mild soap and water. Abrasive cleaners and cleaning cloths will scratch the cover. 6.2 IP44 The Nexus Hand has been tested and certified with IP44 rating, which classifies the degree of protection that is provided against solids and water. The Nexus Hand is protected against solid objects over 1 mm in diameter and is also protected against sprays or splashes from all directions. The wrist interface is not IP44 water or dust resistant as it is highly dependent on the individual socket build. The wrist area on the hand should be kept dry at all times. 6.0 Safety Guidelines

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 6.0 Safety Guidelines 6.6 Sporting Activities The Nexus Hand is not suitable to be worn whilst undertaking extreme sports. These include, but are not limited to: base jumping, sky diving, downhill/enduro mountain biking, motocross, rock climbing, abseiling, bouldering and powerlifting. Any sport that would involve the Nexus Hand getting wet must be avoided. These include, but are not limited to: diving, swimming, snorkelling, surfing, kayaking and canoeing. Avoid using the Nexus Hand for a sporting event to a competitive level. There is likely to be a specific terminal device which would be better suited. 6.4 Operating a Vehicle Although the Nexus Hand can be used for many day-to-day activities, please ensure your patient checks with their local regulations regarding the operation of a motorised vehicle with their Nexus Hand. Please ensure your patient has notified their insurance provider and consult with your patient before they decide to operate a vehicle. If your patient should choose to operate a vehicle, we recommend that their prosthesis is fully charged. In the event of an accident occurring while operating a vehicle with a Nexus Hand or any other COVVI product; COVVI Ltd. shall not be liable under any circumstances. 6.5 Firearms The Nexus Hand should not be used to operate a firearm.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 • COVVI has the right to void the warranty of all products that have any type of modification or damage caused by any unauthorised or untrained personnel. • Individuals who are exposed to hazardous environments that contain flammable liquid or gas should NOT operate the Nexus Hand when in those environments. • Please make sure the Power Supply is OFF before connecting/disconnecting the Nexus Hand to and from the prosthesis as this will avoid any unpredictable spikes in the electric current from the batteries. Power on the Power Supply once the Nexus Hand is properly connected to the prosthesis. • Do NOT expose the Nexus Hand to an open flame or submerge it in water. • Do NOT attempt to use the Nexus Hand while the batteries are charging. When the batteries are charging, the power will automatically turn off. If for any reason the power does not turn off while charging, using the Nexus Hand can be potentially unsafe. • Do NOT use the Nexus Hand without the integrated glove as this could result in increased electromagnetic emissions or decreased electromagnetic immunity of the Nexus Hand and result in improper operation. • Do NOT use the Nexus Hand if the glove is punctured. • Do NOT use the Nexus Hand if a failure occurs, as it could cause damage to your patient or others. • The Essential Performance is to move the digits only when an input signal is applied. Should the fingers and/or thumb move without an input, the patient should stop using the Nexus Hand immediately and contact Customer Services. 6.7 Safety Precautions Please read the following safety precautions prior to using the Nexus Hand. 6.0 Safety Guidelines

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Turning the Nexus Hand on and off is as simple as connecting it to the arm socket via the electronic quick- disconnect. Please see the following diagram for instructions on how to connect the Nexus Hand to the patient’s socket. 7.1 Connecting/Disconnecting the Nexus Hand 7.0 The Nexus Hand Overview If ball bearings are locked out radially, the Nexus Hand will not plug in. Remove protective cap Ensure no debris is inside the core of the Nexus Hand before connecting it to the arm socket.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Connect the Nexus Hand to the socket by pushing the connector into its receiving end on the socket until an audible click is heard. Test the connection by twisting the Nexus Hand 90° clockwise and 90° anticlockwise, then give it a light pull in the opposite direction. When the Nexus Hand powers up you will hear the start-up beep and the screen will display ‘Nexus’ for a second. To disconnect the Nexus Hand from the socket, please rotate the Nexus Hand within the socket until the connection becomes loose. This works either clockwise or anti-clockwise. 7.0 The Nexus Hand Overview If the Nexus Hand is not used for a long period, protect the EQD from debris with the cap. DO NOT use the Nexus Hand if it is visibly damaged.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 To activate and deactivate standby mode, press the dorsal button. 7.0 The Nexus Hand Overview FW: The high-level firmware. The image shows Version 2 followed by the date it was created. GW: The low-level firmware. The image shows Version 2 followed by the date it was created. The Nexus Hand has an E-Paper screen designed to show device information such as current grip, battery life and system notifications. It can also be used to diagnose any issues users may have in a useful way so either you or a COVVI representative can give them a quick solution. The E-Paper screen will always display the following: 7.2 E-Paper Screen Grip Table Estimated Battery Life Bluetooth is enabled Auto Grip is enabled Current Grip

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 7.0 The Nexus Hand Overview When the Nexus Hand is too hot, outside of its normal operating temperature (see section 5.0), the following warning message and icon will appear. If this message appears, please disconnect the hand, and allow it to cool down. When the Nexus Hand is too humid, outside of its normal operating humidity (see section 5.0) the following warning message and icon will appear. If this message appears, please disconnect the hand, and allow it to dry in a warm, dry environment. This may happen if the hand is submerged in water. Any function that refreshes the screen, for example a grip change, will change the message displayed but the warning icon will remain visible. These notifications will appear when downloading a remote firmware update to update the Nexus Hand.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 8.0 Why Nexus? The Nexus Hand combines an extraordinary level of functionality with a captivating design to offer you the best prosthetic hand on the market. 8.1 Passively Flexing Fingers and Thumb From our previous design, we saw how popular the passively flexing fingers were for a prosthetic hand as they played an important role in protecting the expensive actuators. So, we decided to take this one step further and applied it to the thumb. We designed all the digits to be durable by manufacturing them from a combination of stainless steel and aluminium and the spring-loaded feature provides great impact protection as they all fold out of the way reducing the likelihood of damage and repairs.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 8.0 Why Nexus? 8.2 Integrated Flex Wrist Every Nexus Hand comes with an integrated flex wrist which has been a market favourite. By being spring-loaded it makes the wrist faster and more instinctive for the user to use as they do not have to think about moving it, the wrist will move with them. This combined with the passively flexing fingers creates a more natural embodiment of the Nexus Hand as it is not rigid but rather provides organic movements. Another great benefit is that when using the wrist in flex state, if the user were to fall, trip or accidentally knock into something, it is less likely there will be catastrophic damage to the hand as it flexes out of the way. It is also the lowest profile flex wrist on the market with the mechanism incorporated into the hand chassis adding no additional build height. This has been great for those users with a long residual limb as it does not affect symmetry with their sound side. It features a passive spring flex with a single locking button mechanism to lock the wrist into one of three positions: 30° flexion, 30° extension or neutral. This is very useful for users as it reduces shoulder compensation when performing certain tasks such as eating, driving, or using a computer. The flexion position is ideal for when eating, the extension position is ideal for when using a computer while the neutral position provides a stable platform for heavy lifting. 0° Neutral -30° Extension 30° Flexion

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 8.0 Why Nexus? As more functions have been added to prosthetic hands, the more complicated using them has become. An apparent problem arose which was the time it was taking users to access all these new functions with the two main grip switch triggers available. Therefore, we designed our thumb to give users a quick, intuitive, and novel way to change grips via our smart switching option. It works by tapping the side of the thumb which activates the powered rotation and will swing the thumb between opposed and non-opposed positions and can be assigned to whichever action the user would like. We have seen this be incredibly valuable to bilateral users who can simply tap the thumb on the side of their leg, or a hard surface and it will give them fast access to all the grips. 8.4 Water and Dust Resistant (IP44) The Nexus Hand has an integrated medical grade silicone glove with a soft touch coating. This provides the hand with IP44 rated dust and water resistance, giving users that extra protection whilst going about their daily life. We made sure the glove is as durable as possible with thicker integrated fingertips to reduce wear and tear and customisable polycarbonate covers to provide another layer of protection. These covers are painted on the inside for increased durability and make the hand much easier to clean. We believe the combination of the glove and covers gives a look that stands out from the crowd, and the best part; both are easily replaceable in clinic and inexpensive to do so. 8.3 Intuitive Thumb Control/Smart Switching

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 8.0 Why Nexus? Several prosthetic hands are still not touch screen compatible and in some cases a wand is needed to type on a normal keyboard. Thinking of how prosthetics need to respond to modern day life, we designed the Nexus Hand to be compatible with these new technologies. 8.6 Remote Firmware Updates 8.7 Various Grip Switch Triggers To keep the Nexus Hand up to date with the latest features, we are periodically providing new firmware updates. We are the first company in the industry to offer remote firmware updates. We know this is somebody’s hand and a day without it is a massive inconvenience. Our technology now allows users to update their Nexus Hand from the comfort of their home. The Nexus Hand has numerous switching options to give users fast access to a multitude of grips. There is no need for external Bluetooth, accelerometers, or RFID triggers. To change grips or tables users can assign an open/open, long hold open or co-contraction signal, use the dorsal button, the force sensitive resistors in the fingertips and the pronate/supinate thumb tap. We have 14 available grips to help users go about their daily life. 8.5 The Index Fingertip is Touch Screen Compatible

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 9.1 Opposed Grips Trigger Grip This grip is for the use of trigger operated objects such as hairdryers, spray bottles, a power drill or electronic garden tools. When a close signal is sent fingers 2, 3 and 4 will close around an object followed by the thumb to maintain it steady. If the close signal is maintained the index finger will then flex activating the trigger. Power Grip In response to a close signal all four fingers flex towards the palm around an object with the thumb completing the grip by locking over fingers 1 and 2. This is a stable grip for when holding heavier items, but it is also great for daily and manual tasks such as carrying bags, pushing a shopping trolley, or mowing the lawn. 9.0 Grip Patterns Precision Grip (Open & Close) These two grips use the thumb and index finger to give a reliable and fast method of picking up, holding, and using small objects with precision which aids the user as it does not require simultaneous movement of the arm and the fingers. In precision open the thumb moves to a known resting position and the index finger comes to meet the tip of the thumb. The rest of the fingers remain extended allowing the user to get the hand close to the object. In precision closed, fingers 2, 3 and 4 close first, the thumb moves to the known resting position and then the index finger meets the tip of the thumb. This grip is designed to offer the user better visibility of the object they are picking up.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Glove Grip This grip is to aid dressing and undressing as it helps the hand slide through sleeves without catching. The fingers flex slightly and the thumb flexes in towards the palm to put the hand in the slimmest position possible. 9.0 Grip Patterns Rock Grip This grip is not a functional grip. The index and little finger remain extended, while the middle two fingers flex in towards the palm with the thumb closing over them to give the rock gesture. Tripod Grip This grip uses the thumb and first two fingers to hold objects. The thumb and four fingers move simultaneously, but if uninterrupted, fingers 3 and 4 will flex in towards the palm and fingers 1 and 2 will clamp against the tip of the thumb. Active finger tracking ensures a reliable and stable grip.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Key/Card Grip This grip is ideal for holding thin objects like keys, credit cards or paper, but it can also be used in domestic tasks such as carrying plates or holding a knife. In response to a close signal all four fingers partially flex and the thumb closes to meet the distal section of the index finger. Finger Point Grip This grip enables the user to press buttons, ring a doorbell, use a smartphone, or point out directions. Fingers 2, 3 and 4 flex in towards the palm, the thumb closes to a fully flexed position and the index finger remains extended. Tap Grip This grip is very similar to the finger point grip but has the additional function of an active button press. When the close signal is maintained the index finger partially flexes and when the signal is released the index finger extends. This allows the user to keep the wrist static and press a button. 9.2 Non-opposed Grips 9.0 Grip Patterns

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Mouse Grip This grip is specifically designed for using a mouse. When a close signal is received the thumb and little finger move simultaneously to hold the mouse. Reapplying the close signal will partially flex the index finger to tap the mouse and releasing the close signal will extend the index finger again. Only applying an open signal will fully open the hand again. Relaxed Grip This grip provides a natural resting position for when the hand is not in use. The hand is open, but the fingers and thumb are slightly flexed. Phone Grip This grip is not a functional grip. It is to imitate holding a phone. The thumb and little finger remain extended, and the rest of the fingers flex in towards the palm. Column Grip This grip is ideal for a variety of tasks such as pressing buttons, calling lifts, or turning light switches on and off. When a close signal is sent, the thumb flexes to a fully closed position, then all four fingers close simultaneously over the thumb. 9.0 Grip Patterns

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 The Nexus Hand features a two-axis thumb which provides powered thumb flexion and powered thumb rotation. It has a spring-loaded rocker switch which can be used as a grip switch trigger designed to give users fast access to a multitude of grips. In the default setup, Table A starts with opposed grips and Table B starts with non-opposed grips and the thumb pronate/supinate grip switch triggers are for next table and previous table, respectively. However, the thumb can be mapped to any function depending on user preference. The thumb has two open parked positions, opposed and non-opposed. If the thumb is in a non-opposed position and thumb tap pronate is mapped to next grip and the next grip is opposed, the powered rotation will rotate the thumb into an opposed position. The thumb can also be manually rotated. The rocker switch additionally has an impact protection feature, if the user were to fall with the hand in an opposed position, the impact will trigger the rocker switch and move the thumb into a non-opposed position to prevent as much damage as possible. 10.0 The Nexus Thumb Central Axis 7.5° 7.5°

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 10.0 The Nexus Thumb Thumb Tap Pronate at Opposed Thumb Tap Supinate Thumb Tap Pronate For a Left Hand Opposed to Non-Opposed - Tap the Right side of the thumb to move it left Non-Opposed to Opposed - Tap the Left side of the thumb to move it right For a Right Hand Opposed to Non-Opposed - Tap the Left side of the thumb to move it right Non-Opposed to Opposed - Tap the Right side of the thumb to move it left Thumb Tap Supinate at Non- Opposed

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply At COVVI we know that keeping prosthetic devices charged throughout the day can be a challenge, we also understand the fatigue caused by carrying large bulky battery systems all day. We feel the new COVVI Power Supply addresses a number of these issues. We have designed the system around a very compact in-arm Control Panel which includes a USB-C charge socket, on/off button, and a screen to provide accurate power levels. We have coupled this with some extremely slim batteries which fit within the socket avoiding visible lumps on the outer socket. Existing flexible battery systems on the market rely on physically bending the lithium cell, this limits the angle of flex/bend but also affects the amount of charge the battery can hold. Our batteries circumvent this issue as the construction has two solid battery sections linked with a flexible web, delivering 1600mAh. This means the battery can be folded in half without affecting the performance. We kept the weight as low as possible, our system only uses the two batteries which connect directly to the Control Panel without the need for an internal connecter. With a system weight of 84 grams, we have market leading power density which will keep the user powered up all day, but if they do find themselves running short on power, they have the convenience of USB-C charging on the go. For users who need more power and have the room available in their socket, we are offering a high-capacity version which is based on 2 cylindrical cells delivering 2600mAh with a system weight of 130 grams. This system is ideal for users who have a short residual limb. The low weight version of the Power Supply is 1 battery with 4 individual cells joined by a web which allows the system to follow the contours of the inside surface of the prosthetic socket. This system is ideal for users with a long residual limb. Once fitted in a limb, the COVVI power supply is splash resistant and is tested to IP44. If there is water in the USB-C port, please fully dry this out before attempting to charge. 11.1 Contents

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply 2 Batteries Silicone Adhesive 2 Battery Dummies Velcro Control Panel Cutting Template (Located in the front of this manual)

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply AU EU AC USB-C Plug Adaptor UK US CAUTION PRECAUTIONS FOR HANDLING ELECTROSTATIC SENSITIVE DEVICES. Only use with COVVI Batteries

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply • The COVVI Power Supply should be fitted by a certified prosthetist. • This product uses semiconductors that can be damaged by electrostatic discharge (ESD). • This product is not designed to be disassembled or serviced. Damage due to inappropriate handling is not covered by the warranty. • COVVI has the right to void the warranty of all products that have any type of modifications or damage caused by any unauthorised or untrained personnel. • Individuals who are exposed to hazardous environments that contain flammable liquid or gas should NOT operate the COVVI Power Supply. • Please make sure the Power Supply is OFF before connecting/disconnecting the prosthetic device as this will avoid any unpredictable spikes in the electric current from the batteries. Power on the Power Supply once the prosthetic device is properly connected to the prosthesis. • Do NOT expose the COVVI Power Supply to an open flame or submerge it in water. • Do NOT attempt to use the prosthetic device while the batteries are charging. Once the batteries are charging, the power automatically turns off. If for any reason the power does not turn off while charging, using the prosthetic device can be potentially unsafe. • Do NOT use the Power Supply if there is any visible sign of damage to the Power Supply charger, Power Plug and/or Cables. • Do NOT fit the batteries into a small, enclosed space. The batteries are designed to inflate when they fail. Stopping this inflation may cause the generation of excessive heat, injury, or death. • Ensure access to wall plug to enable easy isolation if required. • The COVVI Power Supply should only be used with COVVI batteries. 11.2 Warnings

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply 11.3 COVVI Power Supply Overview 2-pin Output Power Connector to EQD Battery Cell Battery Web Display Screen Power Button Control Panel Battery Connections USB-C Charge Point 1600mAh Option 2600mAh Option

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply The 1600mAh batteries can be bent either way as the brown web is between the four cells. 11.4 The Batteries

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 00-32-0000 CAL 11.0 The COVVI Power Supply 11.5 Activating the System System Capacity Charge Level Calibration Firmware Press and hold the Power Button for two seconds to turn the Power Supply on. The screen will display the COVVI logo followed by the battery capacity, the Power Supply Firmware, and a confirmation of calibration for two seconds in total. Then the screen will show the current battery charge level for five seconds before going blank (with the USB unplugged). The system is now providing power to the hand. To turn the Power Supply off, press and hold the Power Button for two seconds. 1600mAh In normal operation the screen is blank. This is to reduce power consumption. At any time, you will be able to see the remaining battery life by pressing the Power Button. This will show the battery charge level on the screen for five seconds and then go blank again. Press to show for 5 seconds

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply 11.6 Changing the Display Mode It is possible for the user to choose between two display modes, simple bars, or a percentage charge. When the USB is connected and powered, press and hold the Power Button until the display starts to alternate between the two display styles. To select a display style, release the Power Button when your preferred display is shown. Please Note: The screen will not turn off while the USB is plugged in.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply 11.7 Charge Indication 10 blocks equals 100% 9 blocks greater than or equal to 90% 8 blocks greater than or equal to 80% 7 blocks greater than or equal to 70% or or or or 6 blocks greater than or equal to 60% or 5 blocks greater than or equal to 50% 4 blocks greater than or equal to 40% 3 blocks greater than or equal to 30% or or or

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 2 blocks greater than or equal to 20% 1 block greater than or equal to 10% No blocks less than 10% When the system is charging, it will show this screen. 11.0 The COVVI Power Supply Should there be a fault with the Power Supply, the following screen will appear. Please turn off the Power Supply and contact COVVI Customer Services. Press and hold the Power Button to turn off the Power Supply (with the USB unplugged). or or or to

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply 11.8 Fitting the COVVI Power Supply The information below is to be used as a guide, individual prostheses will differ from patient to patient. We would recommend the Control Panel is placed on the upper side of the prosthetic socket for ease of use, but also away from any area which may be loadbearing when carrying heavy items. The batteries are flexible and are designed to conveniently fit between the inner and outer socket wall and retained in place with the Velcro provided. Lamination dummies are also provided if recesses are required in the outer socket wall. The dimensions of the Control Panel are approximately: 45mm x 20mm x 12mm / 1.77” x 0.8” x 0.47” Control Panel Aperture The Control Panel can be inserted into an aperture created in your patient’s prosthetic socket. We have provided a cutting template in the Power Supply Kit for you to follow. Apply the cutting template to the top side of the prosthetic socket then carefully cut along the highlighted red outline with a cutting disc. File down any sharp edges.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply Remove the remaining cutting template and apply a small bead of silicone adhesive to the edge of the aperture. Insert the wires through the aperture before gently pressing the Control Panel into place. The batteries can either be connected to the Control Panel prior to being fitted to the limb or after it is fitted if there is sufficient access space. Position the Control Panel on the limb where it allows easy access to the mains when charging. Removing the plug from the mains socket will isolate the prosthetic device from the mains supply.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply Li-ion Battery COVPS-1600 Typical Capacity 1600mAh Nominal Voltage 7.4V Maximum Current Draw 5A Peak Battery Unfolded (Inches) 3.9 x 1.8 x 0.28 Battery Unfolded (mm) 99 x 46 x 7 Battery Folded (Inches) 3.9 x 0.7 x 0.7 Battery Folded (mm) 99 x 18 x 18 System Weight 84 grams (Including Control Panel) Humidity Maximum 80% humidity, non-condensing Charge Temperature Range 0°C to +45°C Discharge Temperature Range -20°C to +60°C 11.9 System Specification 99mm 46mm 46mm 19mm

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 46mm 19mm 11.0 The COVVI Power Supply Li-ion Battery COVPS-2600 Typical Capacity 2600mAh Nominal Voltage 7.4V Maximum Current Draw 5A Peak Battery Size (Inches) 2.8 x 1.56 x 0.78 Battery Size (mm) 72 x 40 x 20 System Weight 130 grams (Including Control Panel) Humidity Maximum 80% humidity, non-condensing Charge Temperature Range 0°C to +45°C Discharge Temperature Range -20°C to +60°C 72mm 40mm

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply COVPS-1600 Shown CEL-50 CEL-60 CLAMRG-40 CLAMRG-45 CLAMRG-50 CWAK-40 CWAK-45 CWAK-50 COVPS-1600 COVPS-2600 CAXCOR CCOUP

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Ensure the M4 retaining bolt is used to secure the electrode and power cables to CAXCOR. The grounding contact on the coaxial core shown in the picture above can be used for earthing carbon sockets. Please do NOT cut any system cables while the power is ON. This will short the batteries and can cause damage to the system resulting in your warranty being void. 11.0 The COVVI Power Supply Ground Contact Power Input 2 (E2) Input 1 (E1) CAN BUS

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply 11.10 System Compatibility The COVVI Power Supply is compatible with all 7.4V nominal powered upper limb systems and can deliver a peak current of 5.0A. The system should only be used with COVVI batteries and the wall charger provided. Using generic USB-C cables may affect the ability to charge or charge times. Any modification to the COVVI Power Supply can cause injury or death. WARNING: Use of accessories, transducers, and cables other than those specified or provided by COVVI Ltd. could result in increased electromagnetic emissions or decreased electromagnetic immunity of the COVVI Power Supply and result in improper operation. 11.11 Battery Replacement As with all batteries the capacity will degrade overtime, we expect this to become noticeable after 12 months of use. The COVVI Power Supply will support 300 charge and discharge cycles. After this, the time it takes to fully flatten the batteries will become shorter. Replacement cells are available for the COVVI Power Supply, but both batteries must be changed at the same time. There are two versions of spare batteries depending on which version of the Power Supply you ordered. It is imperative that you replace the cells with those of the same capacity, COVSB-1600 is only compatible with the 1600mAh Power Supply and COVSB-2600 is only compatible with the 2600mAh Power Supply. Deplete the old batteries until flat and the limb no longer moves. Then disassemble the limb and replace the cells. Reassemble the limb, connect the batteries to the USB-C charger and allow them to fully charge. If this initial charge is not conducted properly it can negatively affect how the system calculates the remaining charge. Check your local waste regulations to safely dispose of your old batteries.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 11.0 The COVVI Power Supply 11.12 Maintenance The COVVI Power Supply does not require any specific maintenance. The Control Panel can be wiped clean using a damp soft cloth and left to dry. Do not use any solvents or abrasives as they may damage the paint finish, the clarity of the screen aperture or integrity of the silicone moulding. To ensure correct function it is important to inspect the Control Panel carefully and ensure that the USB-C port is free of debris. If debris is discovered please carefully remove this with a thin, but non-metallic object to ensure the port is not damaged. Do not expose the Control Panel or batteries to excessive heat or naked flames as this can cause damage to both the screen and the batteries ability to hold a charge. The COVVI Power Supply is IP44 rated and so will withstand contact with water but should not be submerged in water. If liquid is visible in the screen aperture, please stop using the system and it to your supplier.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 The use of incompatible prosthetic components can cause injury due to unexpected errors. See the table below to show what products are compatible with each other. Any device or component that is not listed below is NOT recommended to be used with the Nexus Hand. 12.0 Component Compatibility Company Product Part Number Compatibility Recommendations Electrodes Ottobock Electrode 13E200=50 Yes Ottobock Electrode 13E200=60 Yes Ottobock Suction Socket Electrode 13E202=50 Yes Ottobock Suction Socket Electrode 13E202=60 Yes Steeper Electrode Elec 50 Yes Steeper Electrode Elec 60 Yes Steeper Seal-in Electrode ELSK50 Yes Steeper Seal-in Electrode ELSK60 Yes Ossur Compact Electrode Kit, 50Hz (300mm cable) PL091050 Yes Ossur Compact Electrode Kit, 50Hz (600mm cable) PL091127 Yes Ossur Compact Electrode Kit, 60Hz (300mm cable) PL091060 Yes Ossur Compact Electrode Kit, 60Hz (600mm cable) PL091127 Yes IBT Element 80101-1 Please see COVVI website

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 12.0 Component Compatibility Company Product Part Number Compatibility Recommendations Elbow Fillauer Utah Arm 3 Base 5010112 (black) Please see COVVI website Fillauer Utah Arm 3 5010038 (black) Please see COVVI website Fillauer Utah Arm 3+ 5010041 (black) Please see COVVI website Fillauer Utah Hybrid Arm 5010044 (black) Please see COVVI website Steeper Espire Pro Elbow Please see COVVI website Steeper Espire Hybrid Elbow Please see COVVI website Steeper Espire Classic Elbow Please see COVVI website Steeper Espire Classic Plus Elbow Please see COVVI website Steeper Espire Basic Elbow Please see COVVI website Ottobock ErgoArm Hybrid Plus 12K44 (all sizes) Please see COVVI website Ottobock ErgoArm Electronic Plus 12K50 (all sizes) Please see COVVI website Ottobock DynamicArm Elbow 12K100N (all sizes) Yes with an Analog Adapter Ottobock DynamicArm Plus Elbow 12K110N (all sizes) Yes with an Analog Adapter Ottobock Analog Adapter 13E100 Yes

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 12.0 Component Compatibility Company Product Part Number Compatibility Recommendations Wrist Ottobock MyoRotronic 13E205 Please see COVVI website Ottobock Electric Wrist Rotator 10S17 Please see COVVI website Fillauer MC Standard Wrist Rotator 5010045 (black) Please see COVVI website Fillauer MC ProWrist Rotator 5010056 (black) Please see COVVI website Pattern Recognition COAPT GEN2 BEMF / AEMF Yes Must use Motion Control wrists IBT Sense 70101-2 Please see COVVI website Ottobock Myo Plus TR 13E520 Please see COVVI website Charger Ottobock MyoCharge Integral 757L35 No Lamination Rings Ottobock Lamination Rings 10S1 (all sizes) Yes Coaxial Plug Ottobock Coaxial Plug 9E169 Yes Coupling Piece Ottobock Coupling Piece 10S4 Yes

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 All systems which are compatible with a standard EQD and can deliver 0 to 5V input signals and 7 to 8.4V power supply. WARNING: Use of the Nexus Hand adjacent to or stacked with other equipment not listed should be avoided because it could result in improper operation. If such use is necessary, the Nexus Hand and the other equipment should be observed to verify that they are operating normally. WARNING: Use of accessories, transducers, and cables other than those specified or provided by COVVI Ltd. could result in increased electromagnetic emissions or decreased electromagnetic immunity of the Nexus Hand and result in improper operation. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Nexus Hand, including cables specified by COVVI Ltd. as this could result in degradation of the performance of this equipment. 12.0 Component Compatibility Company Product Part Number Compatibility Recommendations Batteries Ottobock MyoEnergy Integral 757B35=5 Yes Steeper S-Charge System SCBP2200 Yes Ossur Replaceable Battery Assembly Kit PL238149 Yes Ossur Replaceable Battery Assembly Kit w/ switch block PL238163 Yes IBT FlexCell 1027204-OB Yes Vincent Vincentaccu Flex Flex1290 Yes Connection Cables Ottobock Electrode Cable 13E129 (all sizes) Yes Ossur 3-Way Cable 300mm PL091029 Yes Ossur 3-Way Cable 600mm PL091030 Yes

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 The COVVI Go App has been designed to facilitate you and your patient when configuring their Nexus Hand for the first time. Our primary objective was for it to be easy to use and follow. If your patient is an experienced user, the Nexus Hand has a default setup combining the functionality of other prosthetic devices on the market for efficient interchangeability. If your patient is a new user, as they become more familiar and confident with their Nexus Hand, they can test out different setups and make any changes in the App to best suit their daily activities and lifestyle. This manual will cover ‘version 1.1.x’ of the COVVI Go App. All updates will be available through the Apple App Store and Google Play Store. COVVI Go is compatible with Apple devices running iOS v12.0 and Android devices running Android v8.0. 13.1 COVVI Go 13.0 COVVI Go App

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Basic user functionality is available without having to register. This allows users to view the settings, update the firmware and report bugs. To change settings on a Nexus Hand you need an approved account. New accounts are created on an invite-only basis. You can request access from your supplier who is responsible for approving you. When the App has been downloaded and installed, the icon will appear on the mobile device’s home screen. Select the icon to run the App. The ‘Hand Selection’ screen will show. 13.3 Hand Selection The Nexus Hand communicates with the mobile device via Bluetooth. Bluetooth will need to be enabled on both the Nexus Hand and the mobile device before scanning can begin. If Bluetooth is disabled on the mobile device, the App will notify you. When the Nexus Hand is turned on Bluetooth will be enabled for 60 seconds and then turn off to save battery life. To reactivate Bluetooth, you will need to turn the hand on and off again. If you experience connectivity issues you can reset the Bluetooth communication by erasing the data in the BLE module and resetting it. This will set the communication channel back to default and fix all damaged connections. Press and hold the dorsal button for 10 seconds until you feel a vibration and hear the beep sound. The E-Paper screen will display ‘RESET?’. Press the dorsal button for a further two seconds to clear the memory and reset the communication channels. 13.0 COVVI Go App 13.2 Registration

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Once Bluetooth is enabled on both devices, the serial number will show up on the App, for example “CV1LSQBLWH200010”. Serial numbers may differ if your patient changes the colour of their glove or covers. Click ‘Connect’ to connect to your patient’s Nexus Hand. The first screen is ‘Device Summary’ which summarises the key information about the Nexus Hand. The Input Settings are to tailor the input thresholds to the signals your patient can comfortably achieve. The Setup Wizard is to configure a new hand and the ‘Advanced’ option takes you to the Advanced Configuration to modify the setup without passing through all the stages of the Setup Wizard again. 13.0 COVVI Go App

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.4 Input Settings Clicking on ‘Input Settings’ takes you to a graph where you can see your patient’s inputs in real time and change the thresholds to map the speed of the hand to their signals. This allows your patient to maximise performance of their Nexus Hand. There is the option of one input reading or two input readings. If the user selects single site in operating modes, the signal is shown on Input A. If the user selects dual site, the signals are shown on Input A and B. Example Input Graph 13.0 COVVI Go App On Threshold - This shows the signal strength needed for the hand to move. Max Threshold - This shows the signal strength at which the hand will move at full speed. Any signals above this level will make no difference to speed. There are four primary thresholds: 1. Input A On Threshold 2. Input A Max Threshold 3. Input B On Threshold 4. Input B Max Threshold

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 High Control and Easy Speed are typical threshold setups with the aim being that the user can exceed the Max threshold without excessive strain. The ‘On’ threshold needs to be set above any potential baseline interference, as this is a highly sensitive sensor, to stop any inadvertent movement of the hand. High control has a large difference between the ‘On’ and Max thresholds and offers great control over a wide speed range but does require the ability to achieve high magnitude signals without fatigue. Easy Speed has a small difference between the ‘On’ and Max thresholds and offers high speed without the need for high magnitude signals, but this setup can make it more challenging to get fine control at lower speeds. The closer the ‘On’ and ‘Max’ thresholds are, the less speed control the user will have of the hand. The ‘Triggers’ at the bottom of the screen advise when a successful grip switch trigger has been achieved. This is a useful tool for users to practice the grip switch triggers to ensure they can successfully do them without over exertion. When the box is black, the system is waiting for the grip switch trigger to be applied, when the box turns green it signifies a successful one has been made. The grip switch trigger must be activated for this training tool to work. If the grip switch trigger is disabled, you can activate it in the advanced configuration screen by selecting grip switch triggers and mapping the disactivated one to a specific action. Return to the input settings screen to practice the new trigger. 13.0 COVVI Go App High Control Easy Speed

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 If the option ‘Input Gain’ is selected, another set of bars will appear which allows users to amplify or reduce their input signals to better control their Nexus Hand. For example, a user with dual site control could have a very weak Input A signal but a very strong Input B signal and the option to modify the input gain allows them to increase channel A and at the same time reduce channel B to balance the speed output. If a user has two weak inputs, both can be increased so the user does not get tired from overexerting themselves. It is also useful for the interchangeability between different hands as you can make a Nexus Hand perform the same as other prosthetic devices without having to adjust the electrodes. 13.0 COVVI Go App SUCCESSFUL TRIGGER AWAITING TRIGGER TRIGGER NOT ACTIVE

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.0 COVVI Go App Digital Gain increased to 7 on channel A and decreased to 2.6 on channel B. The Display Period shows the data for ‘5’, ‘10’ or ‘20’ seconds. All changes to the values will be immediately reflected on the Nexus Hand to allow users to test different options in real time and set up their hand to suit their preferences. Please Note: There is a prompt to check if you want to continue with the selected settings or revert back to the previous configuration prior to leaving this section. Default Input Gain Thresholds

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.5 Setup Wizard 13.6 Sensor Interface Screen The Setup Wizard allows you and your patient to configure their Nexus Hand according to their preferences and requirements. Available options have an orange border. All options in grey are features that will be available soon through remote updates. Selecting ‘Exit Setup Wizard’ at the top left of the screen in this section will allow you to leave without making any changes. You need to select the input type. The Nexus Hand can be controlled by different sensor transducers. Electrodes: These are sensors that detect the user’s muscle contractions. A proportional voltage controls the opening and closing of the Nexus Hand with variable speed and force. 13.0 COVVI Go App Force Sensitive Resistors: These are resistive devices that vary their electrical signal with the applied force and are useful when you are short on space in the prosthetic socket. Linear Transducer: These devices offer proportional control of myo-electric components for users with little or no myo-electric signals. These would normally be coupled to a harness and provide an electrical output in response to a linear extension of the device.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Number of Inputs: The Nexus Hand has control strategies for both single or dual site control and these should be selected on the operating modes screen. Input Layout: If your patient uses dual site control, the default setup is Input A for an open signal and Input B for a close signal but these can be reversed if the patient’s electrodes are wired the other way around. 13.0 COVVI Go App The Nexus Hand can be controlled using three different operating modes. The modes available will depend on the user’s selection in the previous section. When the user only has one myo-electric electrode site, a strategy is required to open and close the Nexus Hand. Single Site Fast Open/Slow Close: Single Site Fast Open/Slow Close works by the user giving a signal and the time taken for the signal to exceed the ‘on threshold’ is what determines whether it is an open or close action. A short and long burst time need to be set by your patient. The short time is interpreted as an open signal and the long time is interpreted as a close signal. Once the on threshold is exceeded the direction is locked and the speed is proportional to the magnitude of the input signal, which works the same as dual site. 13.7 Operating Modes

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Single Site Alternating: Single Site Alternating works by alternating signals from the same input using a certain amount of time, customisable by the user, as a reference for the direction of the hand. This mode switches the single input signal between an open action and close action, depending on whether the second signal sent is received before or after the stipulated time. This is the direction change time, which by default is set to 1 second, but can be adjusted in the additional setup screen. The hand is initially assigned to a close action; the first signal will cause the hand to move, after the initial movement has stopped, the direction change time will start. If a second signal is received before the time reaches 1 second, the hand will continue to close; but if a signal is received after 1 second the signal is assigned to an open action. The grip switch triggers open/open and long hold open both work with single site alternating and the trigger duration can be adjusted in the additional setup screen. To change grips, the user must open the hand and when fully open either release the signal and reapply the signal within the stipulated amount of time for an open/open signal or maintain the open signal for a long hold open signal. 13.0 COVVI Go App Dual Site Open/Close: This is the most common operating mode used with the Nexus Hand. It has two input sites, and the default setup has channel A mapped to an open action, and channel B mapped to a close action, but this can be swapped around according to user preference. All grip switch triggers work in this mode and give the user the most flexibility.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.8 Grip Tables A user can have up to four Grip Tables that can be populated with up to six different grips. There are 14 grips to choose from. Tables B, C and D can be empty, but Table A must contain at least one grip, so the hand always has a grip to go into. If the hand is to be used with a COAPT system, remove all grips from tables except the primary grip. The patterns can then be mapped to the grips within the COAPT software. Default Grip Tables: Factory defaults provides two tables populated with the following grips. These are a small mix of opposed and non-opposed grips. Tables C & D are empty and are disabled. A B C D Tripod Key Empty Empty Power Finger Point Empty Empty Key Tripod Empty Empty Finger Point Power Empty Empty Empty Empty Empty Empty Empty Empty Empty Empty 13.0 COVVI Go App

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.9 Grip Switch Triggers Once the grip tables are populated, a method of switching between tables and grips can be configured. As you can see from the figure to the right, there are several options to choose from. A description of the Trigger and Action parameters is also available to help the user decide which is the best option for them. The available Grip Switch Triggers are: Open/Open - An Open/Open signal are two open signals sent one after the other, or an open signal is sent when the hand is fully open, to change grips. Long Hold Open - A Long Hold Open signal is an open signal used to open the hand but is maintained after the hand is fully open to change grips. Adding Grips: To populate a table, click on the plus (+) symbol next to the table name (as shown by the figure on the previous page) and a list of grips appear. Selecting the grips will bring up an image showing you the grip. After selecting a grip and pressing ‘Done’, it will appear in the table in the next available position. If the Table is full, the plus (+) symbol will be disabled. Removing Grips: When a grip has been added it will have a minus (-) symbol to the left of it; clicking this will remove the grip from the table. The minus (-) symbol will be disabled when you only have one grip in Table A. 13.0 COVVI Go App

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.0 COVVI Go App Co-Contraction - Co-contraction is when both inputs pass the ‘Co-contraction’ thresholds within a stipulated amount of time from the ‘On’ threshold being reached. In the input graph the user must set their ‘On’ and ‘Co-contraction’ thresholds for both inputs, but the ‘Co-contraction’ thresholds must be higher than the ‘On’ thresholds. Co-contraction will only work if the hand is fully open. The first input to pass the ‘On’ threshold initiates a timer and if both inputs pass their ‘Co-contraction’ thresholds within this stipulated amount of time there will be a successful co-contraction trigger. Co-contraction can be mapped to any action, however, we would recommend that it is mapped to switching between devices, for example, an elbow to a wrist. If one or both signals do not pass the ‘Co-contraction’ threshold within the magnitude and time criteria stated above, the input with the highest magnitude will be acknowledged as either an open or close signal. If the hand is fully open, a co-contraction is outside of the required criteria, and the signal with the highest magnitude is the open signal; it will be interpreted as an open/open signal. If open/open is mapped as a grip switch trigger, its action will be carried out. Thumb Tap Pronate - Trigger: The thumb is tapped inwards and will move into an opposed position, unless assigned to switch to a non-opposed grip where it will remain in a non-opposed position. Thumb Tap Supinate - Trigger: The thumb is tapped outwards and will move into a non-opposed position, unless assigned to switch to an opposed grip where it will remain in an opposed position. Thumb Tap Pronate at Opposed - The thumb is tapped inwards but will remain in an opposed position. If this trigger is assigned to switch to a non-opposed grip, the thumb will move to a non-opposed position. Thumb Tap Supinate at Non-Opposed - Trigger: The thumb is tapped outwards but will remain in a non-opposed position. If this trigger is assigned to switch to an opposed grip, the thumb will move to an opposed position.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.0 COVVI Go App The available actions are: Trigger Off - No action is assigned. Next Grip - The next grip in the table is selected. Previous Grip - The previous grip in the table is selected. Next Table - The first grip in the next table is selected. Previous Table - The first grip in the previous table is selected. Switch to Table A / B / C / D - The first grip in Table A, B, C or D is selected. Map to Grip - This action allows you to assign a specific grip. Auto Grip - This action only works in tripod grip. If the fingers sense objects are starting to slip, they reapply a small continuous force or pulse to gently grasp objects. It monitors the grip every half a second. This icon signifies that auto grip function is enabled. Index Hold - The Force Sensitive Resistor in the thumb can be configured to activate a Grip Switch Trigger when held for a specific amount of time, customisable to suit user preference. Thumb Hold - The Force Sensitive Resistor in the thumb can be configured to activate a Grip Switch Trigger when held for a specific amount of time, customisable to suit user preference. Four Finger Hold - The Force Sensitive Resistors in the fingers can be configured to activate a Grip Switch Trigger when held for a specific amount of time, customisable to suit user preference. Dorsal Button Hold - The dorsal button can be configured to activate a Grip Switch Trigger when held for a specific amount of time, customisable to suit user preference.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.0 COVVI Go App The additional setup has more features for the user to enable or disable for increased comfort with their Nexus Hand. In mode specific, you and your patient must establish the times for the grip switch triggers chosen in the previous section. An advanced user will most likely have shorter times, a new user will need an adjustment period. Beep - There is an audible alert that notifies the user when the hand is turned on, but it can be mapped to all functions such as standby mode and changing grips and tables. Vibration - There is also the option to be alerted with a vibration. This can be mapped to all functions. Auto Relax - When this feature is enabled, after 30 seconds the hand goes back to an open position. Display Options - This is to enable or disable the display altogether. The display gives the user information about the current state of their Nexus Hand including battery life or warnings. The display uses very little battery power, so we recommend keeping this option enabled. Switch to Primary Grip - The primary grip is the first grip in table A. If the hand is inactive for a certain amount of time, the current grip will change back to the primary grip. This time can be altered to suit user preference. If this time is set to 0 then the default switch back time is disabled. Maximum Finger Strength - As a safety feature, the maximum force of the fingers can be reduced if required. This is useful whilst the user familiarises themselves with their Nexus Hand. Maximum Thumb Strength - As a safety feature, the maximum force of the thumb can be reduced if required. This is useful whilst the user familiarises themselves with their Nexus Hand. 13.10 Additional Setup

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.0 COVVI Go App The operating mode and grip switch triggers that the user chooses will determine what parameters need to be established. For Dual Site Open/Close the following parameters can be established: Open/Open Time - This is the time in which a second open signal must be applied after a first open signal or after the hand is fully opened for it to be interpreted as a grip switch trigger. Long Hold Open Time - This is the time an open signal must be maintained after the hand is fully open for it to be interpreted as a grip switch trigger. Co-Contraction Time - This is the time in which both inputs must pass the ‘Co-contraction’ thresholds after the ‘On’ threshold has been reached. The minimum co-contraction time is 20ms, the default co-contraction time is 50ms, and the maximum co-contraction time is 250ms seconds. Input A Speed & Input B Speed - The maximum speed of the fingers and thumb can be reduced. This is a feature designed to aid new users who are still adapting to using a prosthetic device. Mode Specific

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.0 COVVI Go App For Fast Open/Slow Close the following parameters can be established: Fast Open / Slow Close Time - A signal sent within this time is interpreted as an open signal and a signal sent after this time is interpreted as a close signal. For Single Site Alternating the following parameters can be defined: Direction Change Time - This is the time needed to pass for the signal to have a direction change. Any signal sent within this time will keep the direction of the hand the same. Open/Open Time - This is the time in which a second open signal must be applied after a first open signal or after the hand is fully opened for it to be interpreted as a grip switch trigger. This time must be shorter than the direction change time for it to work. Long Hold Open Time - This is the time an open signal must be maintained after the hand is fully open for it to be interpreted as a grip switch trigger.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 The final screen in the Setup Wizard is the ‘Changes’ screen. Here the user will be able to view all their configuration changes, highlighting their before and after values. To finalise the changes, press ‘Finish’ at the top right of the screen. This will send the changes to their Nexus Hand and the user will have the option to ‘Exit Setup Wizard’ or go to ‘Input Settings’. Exit Setup Wizard: Selecting ‘Exit Setup Wizard’ will simply return you to the Device Summary Screen. 13.11 Changes 13.0 COVVI Go App

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 The Advanced Configuration is an overview of the user’s set up. It also allows users to edit specific settings and features directly rather than going through the Setup Wizard again. Its primary use is when you have an established set up and you want to make an adjustment. All changes are made in real time. 13.12 Advanced Configuration 13.0 COVVI Go App

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 The Config History is a backup option which allows users to save their current configuration and revert to it later. Selecting the ‘+’ button near the top right corner of the Config History screen will allow the user to name and upload their current configuration. All previously saved configurations can be downloaded if you are connected to the internet. Click on ‘Config History’, select the ‘View’ button next to the configuration you would like to restore and click ‘Restore’ to send the previous configuration to your Nexus Hand. All changes are made in real time. This feature enables the user to report any issues they may be having with their Nexus Hand. Clicking the ‘Report A Bug’ option in the Device Summary screen will display a form for the user to fill out and submit to COVVI. When submitting this form, the hand’s configuration will automatically be sent as well. This feature allows the user to reset their Nexus Hand’s configuration to the default configuration the hand had when they first received it. The user can select this option by connecting to their Nexus Hand, shaking their mobile device and selecting ‘Reset Config to Default’. The user will have a list of options to choose from, whether it be a one, a couple, or all parameter groups. 13.13 Config History 13.14 Report a Bug 13.15 Reset to Default 13.0 COVVI Go App

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 13.16 Remote Firmware Updates To continuously improve the Nexus Hand, an integrated update feature runs on the device firmware. These updates will be improvements, new features, bug fixes, etc. All updates must be downloaded before the update process can begin. Click on ‘Firmware Update’ to check if an update is available; if no update is available you will be notified. If an update is available, a box will appear with the new version number and a summary of the changes the update contains. Click ‘Start Update’ to download the new update to the Nexus Hand. Once the update has finished downloading, an option will appear to ‘Update / Restart’ the Nexus Hand. Selecting this will cycle the power and begin the update process. The screen on the dorsal will change to indicate an update is taking place. The Nexus Hand needs to remain connected to a power source during this process. The update takes around 10-15 minutes, we recommend keeping the hand close to the mobile device to keep a strong Bluetooth connection as this will optimise the download speed. When the update is complete, the hand will turn on. 13.0 COVVI Go App

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 A custom firmware update allows a user to download a tailored firmware update for their specific needs. COVVI will provide a unique code for the user to input into the App. This can be done by connecting to their Nexus Hand, shaking their mobile device, selecting ‘Custom Firmware Update’ and inputting the code. Clicking ‘Okay’ and ‘Start Update’ will download the firmware update and initiate the update process. If at any point any errors occur, then please get in contact with COVVI Customer Services: [email protected] 13.17 Custom Firmware Update 13.0 COVVI Go App

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 It is recommended to service the Nexus Hand every year. If the user notices any problems with their Nexus Hand, please contact Customer Services so COVVI Ltd. can perform a service and assist with any maintenance issues. 14.0 Maintenance Do NOT use the Nexus Hand if the glove is punctured.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 The Nexus Hand has a 24-month manufacturer’s warranty included with the purchases of the hand which takes effect from the date of fitting. Products are subject to be evaluated for warranty. COVVI is not responsible for normal wear, and/or damage caused by excessive force, and/or excessive usage beyond the technical design and/or beyond its reasonable means. COVVI warrants its products against defects in material and workmanship within the warranty period. Limitation in those instances where changes, alterations or modifications are made in materials at the request or instruction of the customer, the customer agrees not to claim or commence suit against COVVI based on any such disclaimed warranties. Our obligation is limited only to the repair or replacement of defective parts within the warranty period or, at the sole discretion of COVVI, to refund the purchase price of a full refund, partial refund, or no refund, depending on the condition of the return. The possible refund will be given subject to our Quality Department. Our obligation is limited only to the repair or replacement of defective parts within the warranty period. The original warranty period resumes when the defective part is replaced. Please read these Warranty Terms and Conditions carefully before using all COVVI products and services. We may modify these Terms, for any reason at any time, by posting a new version on our website; these changes do not affect rights and obligations that were defined prior to such changes. There are various limited warranties that apply to manufactured products and goods purchased from COVVI. 15.1 24-Month Manufacturer’s Warranty 15.0 Warranty

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 The Nexus Hand has the option of an extended warranty for up to 36 months which will be added on top of any remaining warranty you have left at that point. The extended warranty can be purchased with the hand or at any time within the 24-month Manufacturer’s Warranty period. Products are subject to be evaluated for warranty. COVVI is not responsible for normal wear, and/or damage caused by excessive force, and/or excessive usage beyond the technical design and/or beyond its reasonable means. COVVI warrants its products against defects in material and workmanship within the warranty period. Limitation in those instances where changes, alterations or modifications are made in materials at the request or instruction of the customer, the customer agrees not to claim or commence suit against COVVI based on any such disclaimed warranties. Our obligation is limited only to the repair or replacement of defective parts within the warranty period or, at the sole discretion of COVVI, to refund the purchase price of a full refund, partial refund, or no refund, depending on the condition of the return. The possible refund will be given subject to our Quality Department. Our obligation is limited only to the repair or replacement of defective parts within the warranty period. The original warranty period resumes when the defective part is replaced. 15.2 Optional Extended Warranty of up to 36 Additional Months 15.0 Warranty

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Only the Nexus Hand is serviceable, all COVVI supporting products are designed to be maintenance free. When any COVVI product is sent in for repairs or to be evaluated for faults, it must be returned to COVVI completely assembled and not tampered with. COVVI has the right to void the warranty of all products that have any type of modifications or damage caused by any unauthorised or untrained personnel. Any form of abuse, neglect, and excessive damage that is caused by usage outside the intended design and technical specifications, and/ or any modifications made towards COVVI products will null and void all warranties. All products received will go through COVVI’s Quality Department to assess the condition of the product sent in. The products are evaluated in the order that they are received. Should the product be under warranty and have any manufacturing and/or workmanship defects, the part(s) will be replaced at no charge. The warranty holder will be informed of any and all defects that are covered and not covered under warranty. Any product out of warranty that is sent in to COVVI will be evaluated by our Quality Department and quoted with repair parts and labour as required. Once the repair estimate is sent to the customer, they will have a 60-day approval period. Once the 60-day approval period expires, COVVI has the right to ship the device back to the customer. 16.0 Warranty Service and Repairs To the fullest extent permitted by law COVVI Ltd. and its affiliates, directors, officers, employees, partners, contractors or agents will not be liable for any losses or damages whether direct, indirect, incidental, special, punitive or consequential resulting from the use of the Nexus Hand and associated products, irrespective of whether or not the Clinician or User has been advised or otherwise might have anticipated the possibility of such loss or damage. COVVI Ltd. and its affiliates, directors, officers, employees, partners, contractors or agents shall not be responsible for strikes, labour slowdowns, war, terrorism, riots, severe weather conditions, natural disasters, acts of God or any other forces beyond the reasonable control of COVVI which may result in direct, indirect, incidental, special, punitive or consequential losses or damage. 16.1 Limited Liability

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 If the user notices any problems with their Nexus Hand, please contact Customer Services so COVVI Ltd. can perform a service and assist with any maintenance issues. Clinicians will need to fill out a Repair Form and obtain a COVVI Repair Number. Get in touch with us via: 020 3949 9500 Phone 17.0 Returns www.covvi.com Website facebook.com/covvi instagram.com/covvi twitter.com/covvi linkedin.com/company/covvi Social Media

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 18.0 Disposal Please check your local regulations prior to disposing any items to avoid having a detrimental impact on health and the environment.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. • United States/FCC ID: A8TBM71S2 • Canada IC: 12246A-BM71S2 • Europe/CE • China/SRRC: CMIIT ID: 2016DJ5890 注意 ! 依據 低功率電波輻射性電機管理辦法 第十二條 經型式認證合格之低功率射頻電機， 非經許可， 公司、商號或使用者均不得擅自變更頻率、加大 功率或變更原設計 之特性及功能。 第十四條 低功率射頻電機之使用不得影響飛航安 全及干擾合法通信； 經發現有干擾現象時，應立即停用，並改善至無 干擾時方得繼續使用。 前項合法通信，指依電信規定作業之無線電信。 低功率射頻電機須忍受合法通信或工業、科學及 醫療用電波輻射性 電機設備之干擾。 R 005-101150 MSIP-CRM-mcp-BM71BLES1FC2 CCAN16LP0011T7 19.0 Symbols Used Li-ion IP44

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 20.0 EU Declaration of Conformity Declaration of Conformity for: The COVVI Wrist Kit Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning Medical Devices. The undersigned declares that the products described in this document meet the Council Directive provisions that apply to them and the CE Mark may be affixed. Edward Varley, CEO December 22nd 2020 Who is the natural and legal person with responsibility for the design, manufacture, packaging and labelling before the device is placed on the market under this manufacturer’s name regardless of whether these operations are carried out by the manufacturer or on his behalf by a third party. General Product Name: COVVI Wrist Kit Legal Manufacturer: (Name on Label) Covvi Ltd., Unit 4 (Direct House), Quayside Business Park, George Mann Road, Leeds, LS10 1DJ, United Kingdom Manufacturers SRN: N/A (Not Yet Available) Basic UDI-DI: 506072613GMN003WY GMDN Code 41086 Variants: As per Appendix II (Available on Request) - Product Listing/Schedule Intended Purpose: To mechanically and electrically connect the patients hand endoprosthesis to their socket, batteries system and electrodes (or other input devices). MDR Classification: Class 1 [Rule 13] Notified Body: N/A EC Certificate: N/A EU Authorised Representative: Advena Limited. Tower Business Centre, 2nd Floor., Tower Street, Swatar, BKR 4013, Malta EU Authorised Representative SRN: MT-AR-000000234 Medical Device Regulation Assessment Route: In conformity with Annexes II and III and have drawn up the DoC in accordance with Article 19 of the Medical Device Regulation.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 20.0 EU Declaration of Conformity Declaration of Conformity for: The COVVI Power Supply Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning Medical Devices. The undersigned declares that the products described in this document meet the Council provisions that apply to them and the CE Mark may be affixed. Edward Varley, CEO January 21st 2021 Who is the natural and legal person with responsibility for the design, manufacture, packaging and labelling before the device is placed on the market under this manufacturer’s name regardless of whether these operations are carried out by the manufacturer or on his behalf by a third party. General Product Name: COVVI Power Supply Legal Manufacturer: (Name on Label) Covvi Ltd., Unit 4 (Direct House), Quayside Business Park, George Mann Road, Leeds, LS10 1DJ, United Kingdom Manufacturers SRN: N/A (Not Yet Available) Basic UDI-DI: 506072613GMN004X2 GMDN Code 36534 Variants: As per Appendix II (Available on Request) - Product Listing/Schedule Intended Purpose: The COVVI Hand is to be used exclusively for exoprosthetic fittings of the upper limbs MDR Classification: Class 1 [Rule 13] Notified Body: N/A EC Certificate: N/A EU Authorised Representative: Advena Limited. Tower Business Centre, 2nd Floor., Tower Street, Swatar, BKR 4013, Malta EU Authorised Representative SRN: MT-AR-000000234 Medical Device Regulation Assessment Route: In conformity with Annexes II and III and have drawn up the DoC in accordance with Article 19 of the Medical Device Regulation.

www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500 Declaration of Conformity for: The NEXUS Hand Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning Medical Devices. The undersigned declares that the products described in this document meet the Council provisions that apply to them and the CE Mark may be affixed. 20.0 EU Declaration of Conformity Edward Varley, CEO December 22nd 2020 Who is the natural and legal person with responsibility for the design, manufacture, packaging and labelling before the device is placed on the market under this manufacturer’s name regardless of whether these operations are carried out by the manufacturer or on his behalf by a third party. General Product Name: NEXUS Hand Legal Manufacturer: (Name on Label) Covvi Ltd., Unit 4 (Direct House), Quayside Business Park, George Mann Road, Leeds, LS10 1DJ, United Kingdom Manufacturers SRN: N/A (Not Yet Available) Basic UDI-DI: 506072613GMN001WU GMDN Code 41497 Variants: As per Appendix II (Available on Request) - Product Listing/Schedule Intended Purpose: The COVVI Hand is to be used exclusively for exoprosthetic fittings of the upper limbs. MDR Classification: Class 1 [Rule 13] Notified Body: N/A EC Certificate: N/A EU Authorised Representative: Advena Limited. Tower Business Centre, 2nd Floor., Tower Street, Swatar, BKR 4013, Malta EU Authorised Representative SRN: MT-AR-000000234 Medical Device Regulation Assessment Route: In conformity with Annexes II and III and have drawn up the DoC in accordance with Article 19 of the Medical Device Regulation.

Quayside Business Park, Leeds, LS10 1DJ Phone: +44 (0)20 3949 9500 Email: [email protected] Website: www.covvi.com v1.2.7 June 2021 Advena Ltd. Tower Business Centre, 2nd Flr., Tower Street, Swatar, BKR 4013 Malta