Mobius Bionics 10112 Prosthetic Arm User Manual DEKA Arm User Guide
Mobius Bionics LLC Prosthetic Arm DEKA Arm User Guide
Users Manual
LUKE Arm User Guide Part Number: LU-09012-001 Revision: 1.8 Date: December 05, 2016 Manufactured by: Mobius Bionics 470 Commercial Street Manchester, NH 03101 www.mobiusbionics.com Copyright Copyright © 2016, Mobius Bionics LLC. All rights reserved. Mobius Bionics LLC proprietary rights are included herein. This document contains Mobius Bionics confidential information and may not be copied, transferred, or disclosed, except as authorized by Mobius Bionics. Trademarks Bluetooth® is a registered trademark of Bluetooth SIG. Wi-Fi® is a registered trademark of Wi-Fi Alliance. Contents Contents About This Guide How to Use This Guide ................................................................................ Conventions ................................................................................................ Terminology................................................................................................ Acronyms ................................................................................................... Contacting Technical Support ....................................................................... Chapter 1 LUKE Arm System Indications for Use ....................................................................................... LUKE Arm System ...................................................................................... Arm Types ............................................................................................ Shoulder Configuration (SC) .............................................................. Humeral Configuration (HC).............................................................. Radial Configuration (RC).................................................................. Batteries and Holster .............................................................................. Internal Battery ................................................................................ External Battery ............................................................................... External Battery Holster .................................................................... Battery Chargers and Charging Dock....................................................... Charging Pad ................................................................................... AC Adapter ..................................................................................... Charging Dock................................................................................. ACI (Arm Control Interface) Module......................................................... Input and Output Control Devices............................................................ IMUs (Inertial Measurement Units)...................................................... EMG (Surface EMG Electrodes).......................................................... Pressure Switches ............................................................................. Rocker Switches ............................................................................... Pressure Transducers ........................................................................ Linear Transducers ........................................................................... Tactor ............................................................................................. Chapter 2 11 12 14 14 15 17 18 19 19 19 19 21 21 22 22 23 24 24 25 26 27 27 27 28 28 29 29 30 Safety Safety Guidelines - Arm ................................................................................ 31 Electromagnetic Interference (EMI) Safety....................................................... 34 Safety Guidelines - Battery ............................................................................ 35 Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/163 Contents Chapter 3 Arm Types and User Controls System Battery Types................................................................................... User Controls and Wrist Display.................................................................... Power ON/OFF Button Location............................................................. Turning the Arm ON and OFF ................................................................ Wrist Display ......................................................................................... Low Battery Icon and Low Battery Alert ......................................... System Fault Icon .......................................................................... Arm Mode LED and Grip Select LEDs ............................................ Display Button ................................................................................. Displaying the Battery Charge Level................................................... Changing the Display Brightness........................................................ Swapping IMUs................................................................................ IMU LED Status ..................................................................................... Hand Open Button................................................................................. Orienting The Arm While Pressing The Hand Open Button ................. Chapter 4 Setting Up the Arm Installing IMUs ............................................................................................. Installing the IMU to the Shoe Clip .......................................................... Installing the Shoe Clip to Your Shoe....................................................... Location and Orientation of the IMUs ...................................................... Waking a Sleeping IMU ................................................................................ Donning (Putting On) the Arm ...................................................................... Chapter 5 49 50 52 53 53 54 Using the Arm Key Concepts .............................................................................................. Switching vs. Motion .............................................................................. Operating Modes ................................................................................... IMU - Walk Detect.................................................................................. IMU - Angle Limit Detect ........................................................................ Mode Change Interlock........................................................................... Zeroing the IMUs ................................................................................... Safe Operation of the System ....................................................................... What To Do If the Arm Is Not In Proper Working Order............................ Arm Is Not in Proper Working Order ................................................. Unsure When Using the Arm............................................................. Grasp Release .................................................................................. Doffing the Arm ............................................................................... Safe Motions ......................................................................................... Taking It Slow........................................................................................ Practicing Safe Operation of the System .................................................. Lifting Heavy Objects ............................................................................. Initializing the Arm....................................................................................... Re-Initializing the Arm .................................................................................. Improper Shutdowns.................................................................................... 38 38 39 40 40 41 41 42 43 43 44 44 45 47 48 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 56 56 57 58 58 59 59 60 60 60 60 61 61 62 62 63 63 64 65 65 -- Rev 1.8 Contents Operating Modes and Motions ...................................................................... Standby Mode (No Motion) ..................................................................... Hand Mode Motions............................................................................... Opening or Closing the Hand............................................................ Compound Wrist Motions ................................................................. Rotating the Wrist ............................................................................ Selecting a Grip ..................................................................................... Power Grip (Grip Select LED 1)......................................................... Tool Grip (Grip Select LED 2) ........................................................... Fine Pinch Closed Grip (Grip Select LED 3) ........................................ Fine Pinch Open Grip (Grip Select LED 4).......................................... Lateral Pinch Grip (Grip Select LED 5) ............................................... Chuck Grip (Grip Select LED 6)......................................................... Grip Detents .................................................................................... Arm Mode Motions ................................................................................ SC Arm Motions .............................................................................. Elbow Flexion - Extension (HC Arm) .................................................. Humeral Internal - External Rotation (HC Arm) ................................... Doffing (Removing) the Arm ......................................................................... Chapter 6 Charging the Batteries Battery Charging Safety ............................................................................... Testing the Internal Battery Charge Level....................................................... Charging the Internal Battery ........................................................................ Testing the External Battery Charge Level...................................................... Charging the External Battery ....................................................................... Removing the External Battery from the Holster ................................. Installing the External Battery in the Holster........................................ Testing the IMU Battery Charge Level ........................................................... Charging the IMU Battery............................................................................. Chapter 7 66 66 66 67 67 69 69 70 71 72 72 73 75 75 75 76 79 80 80 82 82 83 85 86 88 88 89 90 Maintaining and Troubleshooting the Arm Maintaining the Arm .................................................................................... 93 Removing and Replacing the Fingernails, Finger Covers and Hand Cover ... 94 Removing and Replacing Fingernails .................................................. 95 Removing and Replacing Finger Covers ............................................. 96 Removing and Replacing Hand Cover ................................................ 97 Cleaning the Arm................................................................................... 98 Troubleshooting the Arm............................................................................ 100 LUKE Arm System Alerts ..................................................................... 100 Troubleshooting ................................................................................... 101 Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/165 Contents Appendix A Technical Specifications Arm Specifications ..................................................................................... Battery Specifications ................................................................................. AC Adapter Specifications .......................................................................... Charging Pad Specifications........................................................................ Arm Radio Specifications............................................................................ Appendix B Guidance and Manufacturer’s Declaration Electromagnetic Environment...................................................................... Electromagnetic Emissions .................................................................... Electromagnetic Immunity..................................................................... Recommended Separation Distances ........................................................... Essential Performance ................................................................................ 107 112 113 114 115 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 117 117 118 121 122 -- Rev 1.8 Contents List of Figures Figure 1. Figure 2. Figure 3. Figure 4. Figure 5. Figure 6. Figure 7. Figure 8. Figure 9. Figure 10. Figure 11. Figure 12. Figure 13. Figure 14. Figure 15. Figure 16. Figure 17. Figure 18. Figure 19. Figure 20. Figure 21. Figure 22. Figure 23. Figure 24. Figure 25. Figure 26. Figure 27. Figure 28. Figure 29. Figure 30. Figure 31. Figure 32. Figure 33. Figure 34. Figure 35. Figure 36. Figure 37. Figure 38. Figure 39. Figure 40. Figure 41. Figure 42. Figure 43. Figure 44. Figure 45. Arm Types ............................................................................ 20 Internal Battery ...................................................................... 21 External Battery ..................................................................... 22 External Battery Holster.......................................................... 23 Charging Pad for IMU Battery................................................. 24 AC Adapter........................................................................... 24 Charging Dock ...................................................................... 25 ACI Module ........................................................................... 26 Example Inertial Measurement Unit ......................................... 27 Example EMG ....................................................................... 27 Example Pressure Switch ........................................................ 28 Example Rocker Switch .......................................................... 28 Example Pressure Transducer ................................................. 29 Example Linear Transducer .................................................... 29 Example Tactor Output Device................................................ 30 Pinch Point Areas .................................................................. 34 Power Button and LED - SC, HC, and RC Arms With External Battery Only .......................................................................... 39 Power Button and LED - SC and HC Arms with Internal Battery 40 Wrist Display ......................................................................... 41 Hand Open Button ................................................................ 47 Attaching the IMU to the Shoe Clip ......................................... 51 Attaching the Shoe Clip to the Shoe........................................ 52 Hand Open Button ................................................................ 61 Hand Open and Hand Closed ................................................. 67 Compound Wrist Motions ....................................................... 68 Rotating the Wrist .................................................................. 69 Power Grip............................................................................ 70 Tool Grip .............................................................................. 71 Fine Pinch Closed Grip........................................................... 72 Fine Pinch Open Grip ............................................................ 72 Lateral Pinch Grips ................................................................ 74 Chuck Grip............................................................................ 75 Moving the Hand Up or Down ................................................ 77 Moving the Hand Left or Right................................................ 77 Moving the Hand Forward or Backward ................................... 78 Voluntary Elbow Positioning (VEP) .......................................... 79 Elbow Flexion - Extension ....................................................... 79 Humeral Internal - External Rotation........................................ 80 Internal Battery Charging Port and Status Icon ......................... 84 Testing the External Battery Charge Level................................ 85 External Battery Charging Dock and Status LEDs ..................... 87 Removing and Replacing the External Battery .......................... 89 Charging the IMU Battery....................................................... 90 Lateral Pinch Grip - Fully Open ............................................... 94 Removing and Replacing the Fingernails .................................. 96 Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/167 Contents Figure Figure Figure Figure Figure 46. 47. 48. 49. 50. Lace - Securing Hand Cover ................................................... 97 Removing and Replacing the Finger and Hand Covers .............. 98 Dimensions of Shoulder Configuration (In Centimeters) ........... 110 Dimensions of Humeral Configuration (In Centimeters)............ 111 Dimensions of Radial Configuration (In Centimeters) ............... 111 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Contents List of Tables Table 1. Table 2. Table 3. Table 4. Table 5. Table 6. Table 7. Table 8. Table 9. Table 10. Table 11. Table 12. Table 13. Table 14. Table 15. Table 16. Table 17. Table 18. Table 19. Table 20. Table 21. Table 22. Table 23. Table 24. Table 25. Table 26. Table 27. Table 28. Table 29. Table 30. Table 31. Table 32. Table 33. Table 34. Table 35. Table 36. Table 37. Table 38. Arm System Icons ................................................................. 12 Text Conventions.................................................................. 13 Terminology ......................................................................... 14 Acronyms............................................................................. 14 Arm and Battery Types ......................................................... 38 Arm Mode and Grip Select LEDs............................................ 42 Wrist Display Battery Charge Levels ....................................... 43 IMU LED Status.................................................................... 45 Control Types - Switching vs. Motion ..................................... 56 Arm and Operating Modes..................................................... 57 Hand Mode — Motions ......................................................... 66 Grip Select LEDs .................................................................. 69 Arm Mode — Motions........................................................... 76 Internal Battery Charging Port and Status Icon ........................ 84 External Battery Charge Level ................................................ 86 External Battery Charging Dock Status LEDs........................... 87 IMU Battery Charging LED Status .......................................... 91 Troubleshooting - Try This First............................................ 101 Troubleshooting - Wrist Display and System Faults................. 102 Troubleshooting - Arm Function ........................................... 104 Troubleshooting - Power and Battery Charging...................... 105 Arm System Specifications................................................... 107 Operating Environmental Range........................................... 107 Transport and Storage Environmental Range......................... 108 Service Life Specifications.................................................... 108 Mass of Arm Configurations................................................. 109 Dimensions of Arm Configurations ....................................... 109 Battery Charge and Operation Times.................................... 112 Power Specifications - Internal Battery .................................. 112 Power Specifications - External Battery ................................. 112 Power Specifications - IMU Battery....................................... 113 AC Adapter Specifications ................................................... 113 Charging Pad Specifications................................................. 114 Arm Radio Specifications..................................................... 115 Guidance and Manufacturer’s Declaration Electromagnetic Emissions ................................................... 117 Guidance and Manufacturer’s Declaration Electromagnetic Immunity.................................................... 118 Recommended Separation Distances (Part I) .......................... 121 Recommended Separation Distances (Part II) ......................... 122 Rev. 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document Contents 10 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.8 About This Guide The intent of this guide is to help guide you in the use of the LUKE arm system. Read this guide before using the arm. This guide is shipped with the LUKE arm system. How to Use This Guide To learn about the arm and how to use the arm read the chapters in the table below. Read To Learn About... Chapter 1 Overview — Provides a summary of the arm and arm parts. Chapter 2 Safety — Provides WARNINGS and CAUTIONS on using the arm and batteries. Chapter 3 Arm Types and User Controls — Provides information about arm types, batteries, and user controls and displays. Chapter 4 Setting Up the Arm— Tells you how to install the IMUs and don the arm. Chapter 5 Using the Arm— Provides information on key concepts as well as how to safely initialize the arm, change operating modes, and command hand and arm motions. Chapter 6 Charging the Batteries — Provides steps on how to charge all batteries. Chapter 7 Maintenance and Troubleshooting — Tells you how to maintain the arm as well as troubleshoot problems. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document r11 About This Guide Conventions Table 1 describes the arm system icons and Table 2 describes text conventions used throughout this guide. Table 1. Arm System Icons Icon 12 Meaning Description Alert Alerts you to potential injury hazards. Obey all safety messages that follow this symbol to avoid possible injury. Information Note Notice is used to address practices not related to personal injury. CAUTION Cautions indicate a hazardous situation which, if not avoided, could result in minor or moderate injury. WARNING Warnings indicate a hazardous situation which, if not avoided, could result in death or serious injury. Read This Guide Used to instruct you to refer to this guide prior to using the LUKE arm system. Electrically Isolated Equipment Indicates Type BF equipment which is electrically isolated and can safely contact a person’s skin without the risk of electric shock. Radio Transmitter Indicates that equipment contains a radio transmitter. Disposal of Equipment Indicates that equipment should not be disposed of in the trash. Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Conventions Icon Table 2. Meaning Description Recycle Equipment Indicates that equipment should be recycled. Use Indoors Identifies electrical equipment designed for indoor use and should be kept dry. Meets Class II Safety Requirements Identifies equipment that meets the safety requirements specified for Class II equipment according to IEC 61140. MR Unsafe Indicates that equipment is not compatible with magnetic resonance (MRI) environment. Text Conventions Convention Appearance in Text Example Key concepts and emphasized text Appear in bold type. Inertial Measurement Unit Book titles, directories, pathnames, and filenames Appear in italic typeface. LUKE Arm User Guide Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1613 About This Guide Terminology Table 3 describes the terminology used in this guide to describe the arm, socket, and accessories. Table 3. Terminology Term Description Arm Refers to the arm hardware in isolation. Prosthesis Refers to the combination of the socket and the arm. Arm System Refers to the socket, arm, and all related accessories. Acronyms Table 4 lists the acronyms used in this guide. Table 4. Acronyms Acronym 14 Description ACI Arm Control Interface — Controls the interface between you and the Master Arm Controller. EMG Electromyograph — A sensor that is placed on the skin and senses the activation signal of a muscle. EMI Electromagnetic Interference — Interference to the arm’s electronics caused by external electrical sources. HC Humeral Configuration — A type of arm. IMU Inertial Measurement Unit — A control input that is placed on top of a foot or lower appendage. LED Light Emitting Diode — A light that displays a status. MAC Master Arm Controller — The main processing unit of the arm. RC Radial Configuration — A type of arm. SC Shoulder Configuration — A type of arm. SOC State of Charge — The battery charge level. USB Universal Serial Bus — A standard way for a computer to talk to other devices. VEP Voluntary Elbow Positioning — A type of arm motion of the LUKE arm. Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Contacting Technical Support Contacting Technical Support To contact technical support use the following address, web site URL or telephone: Mobius Bionics 470 Commercial Street Manchester, NH 03101 www.mobiusbionics.com 603-239-3834 855-MOBIUS1 (855-662-4871) Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1615 About This Guide 16 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 1 LUKE Arm System This chapter provides an overview of the LUKE arm system which includes the socket, arm, batteries, AC Adapter, charging pad, and arm inputs and outputs. Prior to using the LUKE arm system you must have met with your prosthetist. During the meeting(s) the prosthetist will have performed a number of steps such as: • design and build a custom socket to attach the arm • pick the arm configuration and arm parts to best fit your needs • set up and configure the arm • allow you to test the arm system in a controlled setting Once the prosthetist feels that you have met all demands in order to use the arm they will allow you to use the arm. You should clearly understand how the prosthetist has set up your arm prior to using the arm. Indications for Use The LUKE arm system consists of a prosthetic arm and accessories which are used by a certified prosthetist to create a full upper extremity prosthesis indicated for individuals, age 18 years and older, who have partial or full upper limb amputations or congenital defects. The device is used to assist in activities of daily living (ADLs). Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document r17 Chapter 1: LUKE Arm System LUKE Arm System The LUKE arm system is comprised of a specific arm type and several accessories depending on the arm type. The arm system is described below. RISK OF DEATH OR SERIOUS HARM Do not take apart or change the arm or connected parts. This could lead to harm. Based on your arm’s type and setup you may not have some of the following parts. Note the following concerning the LUKE arm system: • The arm is internally powered (when under battery power). • The arm is designated Class II (when plugged into the AC Adapter). • The arm and all body worn accessories are Type BF applied parts. The IMUs have an IP57 rating. The other body worn components of the arm system, when installed and covers are in place, have an IP52 rating. The IP rating specifies the strength of the enclosure against solids (such as dust) and liquids. An IP52 rating provides resistance to light rain and fine dust. An IP57 rating provides resistance to fine dust and submersion to depths of 1 m. 18 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 LUKE Arm System Arm Types Your LUKE arm is one of the three types listed below and shown in Figure 1. Your prosthetist will have chosen the arm type that best fits your needs and set up the arm for the right or left side as well as proper length. Shoulder Configuration (SC) This arm type is for those amputees with little or no residual limb or for those amputees with limited movement or other restricting factors in their residual limb. Humeral Configuration (HC) This arm type is for those amputees with a residual limb below the shoulder but not including the elbow. Radial Configuration (RC) This arm type is the shortest of the three and is for amputees with a residual limb below the elbow. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1619 Chapter 1: LUKE Arm System Figure 1. Arm Types Shoulder Configuration (SC) Humeral Configuration (HC) Radial Configuration (RC) 20 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 LUKE Arm System Batteries and Holster There are two battery types used to power the arm. Which battery type is used depends on your arm type and how your prosthetist configured the power to the arm. The two batteries are: Internal Battery This battery may be used to power the SC and HC arms and is located within the arm’s forearm. See Figure 2. Depending on how your prosthetist configured your arm you may not have an internal battery. Figure 2. Internal Battery Internal Battery (Inside the Arm) SC and HC Arms Shoulder Configuration (SC) Humeral Configuration (HC) Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1621 Chapter 1: LUKE Arm System External Battery This battery, see Figure 3, is normally worn on a belt or in a pocket and is used in one of two ways: • In SC and HC arms, with an internal battery, it may be used to supplement power to the arm. • In RC arms and in SC and HC arms, without an internal battery, it is used standalone to power the arm. The external battery is used with an external battery holster to power the arm. See External Battery Holster for more information. Figure 3. External Battery External Battery (Outside the Arm) SC, HC, and RC Arms External Battery Holster The external battery is mounted in a holster which in turn can be clipped to a belt or worn in a pocket. See Figure 4. The belt clip can be attached to the holster so that the external battery is in either the vertical or horizontal position. There are two versions of the holster; one with an ON/OFF button and power LED and one without. For more information see Power ON/OFF Button Location. 22 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 LUKE Arm System Figure 4. External Battery Holster Battery Holster with ON/OFF button Battery Holster without ON/OFF button Battery Chargers and Charging Dock There are three components used for charging the batteries: a charging pad, an AC Adapter, and a charging dock. The AC Adapter is used with the charging dock to charge the external battery. To charge an internal battery, the AC Adapter plugs directly into the arm. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1623 Chapter 1: LUKE Arm System Charging Pad A wireless charging pad is provided in order to charge the IMU battery. Figure 5 shows the charging pad. Figure 5. Charging Pad for IMU Battery Charging Pad AC Adapter The AC Adapter is used with the external battery charging dock and to directly charge the internal battery within the arm. The AC Adapter comes with a line cord for use in your country. Figure 6 shows the AC Adapter. Figure 6. AC Adapter AC Adapter 24 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 LUKE Arm System Charging Dock The charging dock is used to charge the external battery. The charging dock has two slots allowing you to charge two batteries at once and is powered by the AC Adapter. When charging the battery you should remove the battery from its holster and place it in the charging dock. Figure 7 shows the charging dock. Figure 7. Charging Dock Charging Dock Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1625 Chapter 1: LUKE Arm System ACI (Arm Control Interface) Module The ACI Module, see Figure 8, receives signals from user inputs (e.g., surface EMG electrodes and pressure transducers) and sends them to the MAC which in turn controls the arm. The ACI Module provides four user inputs and connects to the arm. The arm supports up to four IMU/ACI modules at a time in multiple combinations, with a maximum of two IMUs. For example, your prosthetist may configure the arm to support two IMU modules and two wired ACI modules or four wired ACI modules and no IMUs. Figure 8. ACI Module ACI Module 26 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 LUKE Arm System Input and Output Control Devices The arm uses several input devices and a single output device to control the arm. The following sections describe these devices. IMUs (Inertial Measurement Units) IMUs are placed on top of your shoes and command motion or grip selection by having you tilt your foot. See Figure 9. To install the IMUs see Installing IMUs. Figure 9. Example Inertial Measurement Unit Inertial Measurement Unit EMG (Surface EMG Electrodes) EMGs are placed on your skin or embedded into your socket to maintain contact against your skin. EMGs are used to read electrical signals from underlying muscle contractions. EMGs command motion by having you contract the selected muscle. Figure 10 shows an example of a type of EMG. Figure 10. Example EMG Surface EMG Electrodes When donning the arm system, static electricity discharge to EMGs can damage them. To minimize the chance of EMG damage, touch any metal on the arm before touching the EMGs. If you think the EMG is not working correctly, see Troubleshooting the Arm. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1627 User Controls and Wrist Display IMU LED Status The IMU LED shows the functions of the IMU. Pressing the display button for less than one second causes the IMU battery to blink showing the charge level. Table 8 describes the functions of the IMU LEDs. Table 8. IMU LED Status Function Color Status Description Normal Operation Blue One blink every five (5) seconds IMUs are operating normally and are communicating with the arm. Walk Detect Blue Solid Indicates walk detect mode. For more information see IMU - Walk Detect and Zeroing the IMUs. Fault Amber Blinking Indicates a sensor self-test has failed. Try resetting the IMU by removing it from the charging pad, waiting five (5) seconds, and then placing the IMU on the charging pad. If the condition continues contact Technical Support. See Contacting Technical Support. Solid Indicates charging has been paused. The system should recover from this condition. If after 30 minutes charging does not continue, contact Technical Support for service on the charger or the IMU. See Contacting Technical Support. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1645 Chapter 3: Arm Types and User Controls Table 8. 46 IMU LED Status Function Color Status Description Checking Battery Charge Level or Shaking to Wake Blue 5 blinks every 5 seconds (3 times) Fully charged (80% to 100%) 4 blinks every 5 seconds (3 times) Charge level is dropping (60% to 80%) 3 blinks every 5 seconds (3 times) Charge level is dropping (40% to 60%) 2 blinks every 5 seconds (3 times) Charge level is dropping (20% to 40%) 1 blink every 5 seconds (3 times) Low battery (0% to 20%). See Charging the IMU Battery. Sleep Mode Off No blinks IMU is in sleep mode. See Waking a Sleeping IMU. Discharged Battery Off No blinks IMU battery is discharged. See Charging the IMU Battery. Awake and Waiting Off No blinks IMU is awake and waiting to connect to the arm. Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 4 Setting Up the Arm This chapter provides information on how to set up the arm. Based on how your prosthetist configured your arm, you may need to install some arm parts and then don the arm to ensure proper fit prior to using the arm. Topics in this chapter include: • Installing IMUs • Donning (Putting On) the Arm Before installing the arm parts and donning the arm be sure to visually inspect all the arm parts and the arm for any sign of damage. If there is any sign of damage, contact Technical Support. See Contacting Technical Support. Installing IMUs If your arm’s control scheme calls for IMUs with shoe clips, you can install them at this time. There are two steps to installing the IMU: 1. Attaching the IMU to the shoe clip. 2. Attaching the shoe clip to your shoe. If you need help putting on and taking off the IMUs with shoe clips, have your caregiver available at this time. The IMUs have an IP57 rating. The IP rating specifies the strength of an enclosure against solids (such as dust) and liquids. An IP57 rating provides resistance to water at depths up to 1 m (39 inches) and resistance to fine dust. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document r49 Chapter 4: Setting Up the Arm The IMUs will not provide data if dramatically tipped (close to vertical). Be sure to position the IMU as close to level as possible when installing the IMU. If you attach the IMU to your shoe at a severe angle to begin with, the IMU will not provide the full range of motion after zeroing. Installing the IMU to the Shoe Clip To install the IMU to the shoe clip see Figure 21 and perform the following steps: Be sure to install the IMU(s) onto the correct foot as configured by your prosthetist. DO NOT SWAP THE IMU(s) DURING INSTALLATION. 1. Slide the tabbed end of the IMU into the open end of the shoe clip. When installing the IMU onto the shoe clip, please ensure the following: • The Front Arrow label on the bottom of the IMU is facing towards your toes. • Keep the IMU aligned with the direction of movement. This will prevent any cross talk from occurring. 2. Press down on the IMU until the shoe clip retention tab snaps into the IMU slot. Ensure the IMU is fastened securely to the shoe clip. 50 • The shoe clip can be put on the shoe either before or after the IMU is installed on the shoe clip. • You can attach the IMU to the shoe by alternate means (i.e., straps or pockets) as long as it is securely attached. Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Installing IMUs Figure 21. Attaching the IMU to the Shoe Clip IMU Tab Front Label Open End of Shoe Clip Part 1 Press Down On IMU IMU Tab Part 2 Front Open End of Shoe Clip Part 3 Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1651 Chapter 4: Setting Up the Arm Installing the Shoe Clip to Your Shoe To install the shoe clip to your shoe see Figure 22 and perform the following steps: • Note that the shoe clip can be installed onto your shoe with the shoe off your foot or on your foot. • Once you have installed the shoe clip, the shoe clip can remain on the shoe. 1. Orient the shoe clip so that the open end of the clip is facing towards your toes. 2. Slide the shoe clip under the laces of the shoe (left or right). When installing the shoe clip to the shoe, please ensure the following: • The shoe clip passes through at least two of the shoe’s laces to ensure the clip is secure and stable. • The Front Arrow label on the bottom of the IMU is facing towards your toes. 3. Tighten the laces to secure the IMU and shoe clip to the shoe. 4. If you have not already done so put on the shoe. 5. Once you have installed the IMUs you can don (put on) the arm. See Donning (Putting On) the Arm. Figure 22. Attaching the Shoe Clip to the Shoe Open End of Shoe Clip NOTE: IMU is shown attached to shoe clip. 52 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Waking a Sleeping IMU The IMUs do not contain an ON/OFF button. An IMU that is awake and set up to communicate with an arm will do so once the arm is powered ON. See Waking a Sleeping IMU and Initializing the Arm. Location and Orientation of the IMUs During the configuration process your prosthetist will have located and oriented the IMUs to ensure proper operation of the arm. Be sure to locate and orient the IMUs per your prosthetist’s instructions. Waking a Sleeping IMU When an IMU has not communicated with the arm for more than 30 minutes, the IMU reverts to a sleep mode to conserve the battery. When in sleep mode the IMU is not listening for arm communication. As a result, if the IMU is in sleep mode when the arm is turned on, it will not connect with the arm. This results in the Grip Select LEDs sweeping while the arm is trying to find the IMUs. If no IMUs are found, the System Fault Icons on the wrist display blink along with an “IMU Comm Lost” fault code. Shaking your foot with the IMU attached wakes the IMU from sleep mode so that the IMU is ready to communicate with the arm once the arm system is powered up. An IMU that has been shaken awake is waiting to communicate with the arm. IMUs that are not actively communicating with an arm blink the battery state of charge whenever they are shaken, regardless of whether they are sleeping or not. If the IMU does not communicate with the arm within five (5) minutes of being shaken awake, the IMU reverts back to sleep mode to conserve the battery. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1653 Chapter 5: Using the Arm IMU - Walk Detect The IMUs are designed to detect rapid foot movements (such as those seen while walking) and not use these movements as arm commands. For example, if you shake your feet the IMUs would detect this as motion other than a normal command. When walk detect is active, the white Arm Mode LED blinks rapidly and the blue IMU LED is solid. Note that when walk detect is active you will not be able to move the arm using the IMUs, however, non-IMU controls will continue to function as configured. If you are concerned about arm movement while walking (or at other times) put the arm in Standby mode prior to walking. When you stop walking and the IMUs come to rest, the arm reverts back to the previous mode (Arm or Hand) the arm was in prior to entering walk detect and resumes normal operation. This happens automatically when the IMU commands return to zero. If the walk detect LED continues to blink, this indicates that the arm is still receiving a command from one of your inputs. To resolve this issue, make sure your IMUs are positioned correctly, your feet are flat/normal to the ground and you are not activating any other inputs. If you cannot resume normal operation of the arm and the white Arm Mode LED continues blinking with your feet flat on the ground, the IMU zero point is incorrect and the current signal level is above a set threshold. To fix this issue you need to re-position the IMUs on your feet or zero the IMUs by going into Standby mode. See Zeroing the IMUs. IMU - Angle Limit Detect The IMUs are designed to detect when you exceed the IMUs’ angle limit. This occurs when you tip the IMUs more than 45 degrees since the last time the IMUs were zeroed or were out of range. As a result, the white Arm Mode LED on the Wrist Display blinks rapidly informing you of the problem. If the IMUs exceed 45 degrees, you will not be able to move the arm with the IMUs, however, non-IMU controls will continue to function as designed. To resume normal operation you need to return your foot/feet to the rest or zero position. If the white Arm Mode LED continues to blink, you need to reposition the IMUs, re-position your feet, or zero the IMUs by going into Standby mode. See Zeroing the IMUs. 58 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Key Concepts Mode Change Interlock If you are in the process of switching modes (Standby to Hand mode or Hand to Arm mode) and the system detects a command to move, the mode change interlock becomes active. As a result, the white Arm Mode LED on the Wrist Display blinks rapidly informing you of the problem. You can switch modes when mode change interlock is active, however you will not be able to command the arm. When the IMUs are returned to the zero position or the wired input falls below the activation threshold you will be able to command the arm. If the problem does not clear automatically and the white Arm Mode LED continues to blink, you need to re-position the IMUs/feet or zero the IMUs by going into Standby mode (See Zeroing the IMUs) or you need to ensure the wired inputs are not activated. Zeroing the IMUs Zeroing the IMUs establishes a neutral position. When you take the arm out of Standby mode the system zeros the IMUs by taking a snapshot of the IMU’s position and identifies that position as neutral. For example, if you should take the arm out of Standby mode while your feet and attached IMUs are in an inclined position the IMUs will be zeroed at that position. If you should then place your feet and IMUs in a different position without zeroing the IMUs the result could be unintended arm motion. To ensure this does not occur re-zero the IMU s by performing the following steps: 1. Using the designated mode input place the arm in the Standby mode. 2. Place your feet at the position you want to zero the IMUs (usually feet flat on the ground). 3. Using the designated mode input take the arm out of Standby mode. 4. The IMUs are now zeroed for that position and the IMU LED blinks blue once every five (5) seconds. If you have to continually re-zero the IMUs while not changing the neutral position you should check to ensure the IMUs and shoe clips are securely attached to your shoes. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1659 Chapter 6: Charging the Batteries Charging the IMU Battery To charge the IMU battery you need to remove the IMU from its shoe mounting clip and place the IMU on the charging pad. Note the following when charging the IMU battery: • IMUs cannot be charged during use. The prosthesis stops functioning and the System Fault Icon on the wrist display illuminates if this is attempted. • Do not place any objects on the charging pad other than the IMUs. • Mobius Bionics suggests that you charge the IMU battery overnight. • The estimated time to recharge an empty IMU battery to 80% capacity is less than 2.0 hours. • You can charge up to two IMUs at a time on the charging pad. See Figure 43 to see how the IMU is placed on the charging pad and Table 17 for a description of the IMU charging status LEDs. Figure 43. Charging the IMU Battery Power Cord Charging Pad Status LEDs IMUs Charging Pad 90 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Charging the IMU Battery Table 17. IMU Battery Charging LED Status Function Color Status Description Charging Blue Slow Blinking IMU is performing a self-test. Fast Blinking Battery is charging. NOTE: A fully discharged IMU may need to partially charge before the LED will blink blue. When the IMU is on the charging pad, the charging pad’s status LEDs will be blue. Fault Solid Battery is fully charged. Amber Blinking Indicates a sensor self-test has failed. Try resetting the IMU by removing it from the charging pad, waiting five (5) seconds, and then placing the IMU on the charging pad. If condition continues contact Technical Support. See Contacting Technical Support. Amber Solid Indicates charging has been paused. The system should recover from this condition. If after 30 minutes charging does not continue, contact Technical Support for service on the charger or the IMU. See Contacting Technical Support. To charge the IMU battery perform the following steps: 1. Turn OFF the arm. 2. Plug the charging pad’s AC Adapter into an electrical outlet. 3. Remove the IMU from its shoe mounting clip. 4. Set the IMU on the charging pad circle. (One IMU per circle). Ensure the IMU is placed on the pad with the LED facing up, so you can view the IMU LEDs. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/1691 Chapter 6: Charging the Batteries 5. Ensure the charging pad status LEDs are ON when charging the IMUs. See Figure 43. 6. View the status of the IMU battery charge status LEDs. See Table 17. 7. Reattach the IMU to its shoe clip. The IMU is now ready for use. You cannot replace the IMU battery. If there is a problem with the IMU battery, turn the arm power OFF, doff the arm, and contact Technical Support. See Contacting Technical Support. IMUs are awake and waiting for communication from the arm once it is removed from the charging pad. However, the IMU goes into sleep mode if it has not communicated with the arm within 30 minutes. See Waking a Sleeping IMU. 92 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Chapter 7: Maintaining and Troubleshooting the Arm Troubleshooting the Arm This section provides basic troubleshooting steps to help you find and resolve possible problems that may occur with the arm. It also describes how alerts are generated and indicated to identify possible problems. If at any time you feel the arm is not in proper working order (e.g., slow to move, hard to control, making odd sounds, etc.) turn the battery power OFF and contact Technical Support at once. See Contacting Technical Support. LUKE Arm System Alerts The arm system generates alerts to indicate possible problems. Many of these alerts are indicated by LEDs. The LED may blink or turn a certain color to indicate the alert. The arm system may also sound a tone to indicate an alert. All alerts are low priority alarms and technical alarms. Alerts may be generated when: • A battery is discharged • Hardware is damaged Alerts are generated when: • Communication with an IMU is lost • You attempt to charge an IMU when the prosthesis is in operation To learn more about these alerts see User Controls and Wrist Display and Chapter 6, “Charging the Batteries”. 100 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Troubleshooting the Arm Troubleshooting The following tables provide solutions to solving problems with the arm. Table 18. Troubleshooting - Try This First These basic tips may help you quickly solve problems with the arm: TRY THIS FIRST 1. Put the arm into Standby Mode. 2. Check and secure the IMUs on your feet. 3. Take the arm out of Standby Mode. 1. Power the arm off. 2. Shake the IMUs to wake them. Look for the blinking blue LEDs. 3. Make sure all cables are securely connected. 4. Put your feet flat on the ground 5. Power the arm on. See the tables below to help you in troubleshooting problems with the arm system: • Table 19, Troubleshooting - Wrist Display and System Faults – • Table 20, Troubleshooting - Arm Function – • Use this table for help when Wrist Display LEDs are on or flashing Use this table for help with moving the arm or changing grips Table 21, Troubleshooting - Power and Battery Charging – Use this table for help with powering the arm on and charging batteries If the solutions in these troubleshooting tables do not solve the problem with the arm, contact Technical Support. See Contacting Technical Support. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/16101 Chapter 7: Maintaining and Troubleshooting the Arm Table 19. Troubleshooting - Wrist Display and System Faults Problem Cause Solution System Fault Icons Blinking IMU not awake 1. Power the arm off 2. Shake the IMUs to wake them Fault Code: 3 3. Power the arm on IMU battery low 1. Power the arm off 2. Shake the IMU to check the IMU battery charge level and charge if necessary 3. Power the arm on Ham radios, walkie talkies, theft detectors, or metal detectors are affecting the arm 1. Power the arm off 2. Move the arm at least 0.5 m (20 inches) away from any ham radios, walkie talkies, theft detectors, or metal detectors 3. Power the arm on System Fault Icons Blinking Fault Code: 36 ACI not talking to arm 1. Power the arm off 2. Check and tighten all system cables 3. Power the arm on System Fault Icons Blinking Fault Codes: 25, 26, 34, 256 Arm motors warm 1. Power the arm off 2. Move to a cooler location if possible 3. Wait 15 minutes 4. Power the arm on System Fault Icons Blinking Contact Technical Support. See Fault Code Not Listed Contacting Technical Support. 102 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Troubleshooting the Arm Table 19. Troubleshooting - Wrist Display and System Faults Problem Cause Solution Low Battery Icon On Battery is low Replace the external battery in the holster with a fully charged battery. Plug the AC Adapter into the forearm charging port Grip Select LEDs Sweeping Sweeping Arm Mode LED Blinking External battery not connected 1. Check that the external battery is properly seated in the holster 2. Check and tighten the cables between the arm and the holster IMU not talking to arm Shake the IMUs to wake them IMU battery is low Charge the IMUs Ham radios, walkie talkies, theft detectors, or metal detectors are affecting the arm Move the arm at least 0.5 m (20 inches) away from any ham radios, walkie talkies, theft detectors, or metal detectors Walk Detect 1. Stop walking 2. Put your feet flat on the ground 3. Check that the Arm Mode LED has stopped blinking IMU tilted too far 1. Put the arm into Standby Mode 2. Check and secure the IMUs on your feet 3. Put your feet flat on the ground 4. Take the arm out of Standby Mode Input device not working Contact Technical Support. See Contacting Technical Support. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/16103 Chapter 7: Maintaining and Troubleshooting the Arm Table 20. Troubleshooting - Arm Function Problem Cause Solution Arm moving without command IMU zero position changed 1. Put the arm into Standby Mode 2. Check and secure the IMUs on your feet. 3. Put your feet flat on the ground 4. Take the arm out of Standby Mode Sweat near EMGs 1. Put the arm into Standby Mode 2. Wipe the sweat from the EMG electrode and skin with a dry cloth 3. Take the arm out of Standby Mode Ham radios or walkie talkies are affecting the arm 1. Put the arm into Standby Mode 2. Move the arm at least 0.5 m (20 inches) away from any ham radios or walkie talkies 3. Take the arm out of Standby Mode Arm not moving Arm is in Standby Mode Put the arm into Hand Mode Arm is off 1. Shake the IMUs to wake them 2. Power the arm on Arm is faulted See Table 19, Troubleshooting - Wrist Display and System Faults. Input device not connected 1. Power the arm off 2. Check and tighten all connections at the ACI 3. Power the arm on Cannot change Modes Input device not connected 1. Power the arm off 2. Check and tighten all connections at the ACI 3. Power the arm on Input device not working Contact Technical Support. See Contacting Technical Support. Cannot change grips Hand is not fully open 1. Put the arm into Hand Mode 2. Fully open the hand 3. Change grips Input device not working Contact Technical Support. See Contacting Technical Support. 104 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Troubleshooting the Arm Table 21. Troubleshooting - Power and Battery Charging Problem Cause Solution Arm does not power on Internal battery too low 1. Plug the AC Adapter into the forearm charging port 2. The charging status icon first blinks yellow for a few minutes. Wait until the charging status icon blinks blue. 3. Power the arm on External battery too low 1. Replace the external battery in the holster with a fully charged one 2. Power the arm on External battery not connected 1. Check that the external battery is properly seated in the holster 2. Check and tighten the cables between the arm and the holster 3. Power the arm on Internal Battery Charging Charging Status Icon Blinking Yellow Internal battery charging paused 1. Move the arm to a cooler location 2. Wait up to 2 hours. You can keep the arm on and the AC adapter connected while waiting. 3. Charging should continue on its own. If it does not, contact Technical Support. See Contacting Technical Support. Charging Status Icon On Solid Yellow Internal battery charging fault Contact Technical Support. See Contacting Technical Support. Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/16105 Chapter 7: Maintaining and Troubleshooting the Arm Table 21. Troubleshooting - Power and Battery Charging Problem Cause Solution Charging Dock Fault Status Blinking Yellow Charging paused 1. Wait up to 2 hours. You can keep the charging dock on and the battery in the charging dock while waiting. 2. Charging should continue on its own. If it does not, contact Technical Support. See Contacting Technical Support. Charging Dock Fault Status On Solid Yellow Charging fault Contact Technical Support. See External Battery Charging Contacting Technical Support. IMU Charging IMU Yellow LED On Solid Charging paused 1. Wait up to 30 minutes. You can keep the charging pad on and the IMU on the charging pad while waiting. 2. Charging should continue on its own. If it does not, contact Technical Support. See Contacting Technical Support. IMU Yellow LED Blinking Self test failure 1. Remove the IMU from the charging pad 2. Wait 5 seconds 3. Place the IMU on the charging pad 4. If the error persists, contact Technical Support. See Contacting Technical Support. IMU LED off IMU not talking to charging pad 1. Clean the top of the charging pad. 2. Clean the bottom of the IMU. 3. Place the IMU, LED side up, on the charging pad’s center circle. If the solutions in these troubleshooting tables do not solve the problem with the arm, contact Technical Support. See Contacting Technical Support. 106 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 A Technical Specifications This appendix provides technical specifications for the LUKE arm, battery, AC Adapter and charging pad. Arm Specifications Table 22. Arm System Specifications Parameter Range/Explanation Compliance The LUKE arm system complies with IEC 60601-1:2005 Power Type The arm is internally powered when under battery power Designation The arm is designated Class II when plugged into the AC Adapter Parts Type The arm and all body worn accessories are Type BF applied parts Table 23. Operating Environmental Range Parameter Operating Temperature Range/Explanation • 10 °C to 40 °C (50 °F to 104 °F) with no degradation in performance • -10 °C to 50 °C (14 °F to 122 °F) with reduced arm speed and/or load capacity Humidity 15% to 93% (non-condensing) Pressure 700 hPa to 1060 hPa Arm and body worn Mobius Bionics supplied accessories IP rating IP52 Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 107 Appendix A: Technical Specifications Table 23. Operating Environmental Range (Continued) Parameter Range/Explanation IMU IP Rating IP57 When using the arm continuously in a hot environment (40°C, 104°F) and while charging the internal battery, portions of the forearm and upper arm (if applicable) could reach temperatures of 54°C - 57°C (130°F - 135°F), when evaluated as directed in IEC60601-1: 2005-12. Table 24. Transport and Storage Environmental Range Parameter Range Storage Temperature (excluding battery) -25 °C to 70 °C (-13 °F to 158 °F) Humidity 15% to 93% (non-condensing) Pressure 700 hPa to 1060 hPa Table 25. Service Life Specifications Part Service Life Arm Expected to function for up to three (3) years with an 18 month service interval Internal and External Batteries Expected to provide at least 80% of new capacity for up to a year of typical use IMU Battery Expected runtime is at least 18 hours for up to a year of use AC Adapter and Charging Pad Expected to function for up to three (3) years External Battery Holster and External Battery Charging Dock Expected to function for up to three (3) years ACI and Cables Expected to function for up to three (3) years 108 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Arm Specifications Table 26. Mass of Arm Configurations Arm Configuration Mass Shoulder Configuration (SC) 4.7 kg Humeral Configuration (HC) 3.4 kg Radial Configuration (RC) 1.4 kg Table 27. Dimensions of Arm Configurations Arm Configuration Dimensions Shoulder Configuration (SC) See Figure 48 Humeral Configuration (HC) See Figure 49 Radial Configuration (RC) See Figure 50 Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/16109 Appendix A: Technical Specifications Figure 48. Dimensions of Shoulder Configuration (In Centimeters) 9.8 23 23.2323 See Note 23aa 26.4 See Note 2 4.3 23.4 38.6 26.4 14.5 19.5 110 • NOTE 1: Upper arm length configurations in 1 cm increments from 26.4 to 31.4 cm. See Arm Types. • NOTE 2: Forearm length configurations in 1 cm increments from 23.4 cm to 27.4 cm. See Arm Types Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Arm Specifications Figure 49. Dimensions of Humeral Configuration (In Centimeters) 14.5 12.7 17.3 23.4 19.5 See Note 3 • NOTE 3: Forearm length configurations in 1 cm increments from 23.4 cm to 27.4 cm. See Arm Types. Figure 50. Dimensions of Radial Configuration (In Centimeters) 12.1 31.6 14.5 Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/16111 Appendix A: Technical Specifications Battery Specifications Table 28. Battery Charge and Operation Times Arm System Configuration Battery Type One (1) Hour Charge Operation Time1 SC/HC Internal Battery One (1) Hour Two (2) Hours SC/HC External Battery Two (2) Hours Five (5) Hours RC External Battery Four (4) Hours Ten (10) Hours IMU Not Applicable Not Applicable One (1) Day Full Charge2 Operation Time1 NOTES: 1. Actual use time may vary from stated figures based on use patterns, battery age, and arm configuration. Contact Technical Support for additional information. See Contacting Technical Support. 2. See Chapter 6, “Charging the Batteries” for charging time. Table 29. Power Specifications - Internal Battery Parameter Range/Explanation Battery Type Lithium-Ion Capacity 30 Watt-Hours Charging time (approximate) 80% capacity in less than 2.0 hours Storage Life Three (3) months without recharging Storage Temperature Short Term (24 Hours Maximum): -25°C to 70°C (-13°F to 158°F) Long Term: -10°C to 50°C (14°F to 122°F) Table 30. Power Specifications - External Battery Parameter Range/Explanation Battery Type Lithium-Ion Capacity 74 Watt-Hours Charging time (approximate) 80% capacity in less than 2.0 hours Storage Life Three (3) months without recharging 112 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 AC Adapter Specifications Table 30. Power Specifications - External Battery (Continued) Parameter Range/Explanation Storage Temperature Short Term (24 Hours Maximum): -25 °C to 70 °C (-13 °F to 158 °F) Long Term: -10 °C to 50 °C (14 °F to 122 °F) Table 31. Power Specifications - IMU Battery Parameter Range/Explanation Battery Type Lithium-Polymer Capacity 190 mAh Charging time (approximation) 80% capacity in less than two (2.0) hours Storage Life Three (3) months without recharging Storage Temperature Short Term (24 Hours Maximum): -25 °C to 70 °C (-13 °F to 158 °F) Long Term: -10 °C to 50 °C (14 °F to 122 °F) AC Adapter Specifications Table 32. AC Adapter Specifications Parameter Range/Explanation Input Voltage 100 VAC - 240 VAC Input Frequency 50/60 Hz Input Current 1.5 Amps Operating Temperature 0 °C to +70 °C (32 °F to 158 °F) Operating Humidity 10% to 95% RH, non-condensing Storage Temperature -40 °C to +80 °C (-40 °F to 176 °F) Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/16113 Appendix A: Technical Specifications Charging Pad Specifications Table 33. Charging Pad Specifications Parameter Range/Explanation Input Voltage 100 VAC - 240 VAC Input Frequency 50/60 Hz Current Rating 1 Amp Maximum Transmit Frequency Range 100 kHz - 205 kHz Transmit Power <5 W Protocol Qi version 1.1, Wireless Power Consortium Effective Range 10 mm or less Wireless Security Qi version 1.1 Quality of Service Provisions Any debris or clutter between the bottom of the IMU and the Charging Pad may prevent IMU charging. Any increase in the distance between the IMU and Charging Pad will increase communication interference. This interference, however, will not cause any incorrect data to be sent and will not cause any harm to the LUKE arm system. Loss or corruption of data between the IMU and Charging Pad for more than 2 seconds can result in the interruption of charging. In these cases, communication problems can usually be resolved by ensuring the top of the Charging Pad is clean and clear of clutter, the IMU is clean and its label is free of wrinkles, and that IMUs are placed label side down and placed as close as possible to the center of the charging pad targets. 114 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 Arm Radio Specifications Arm Radio Specifications Table 34. Arm Radio Specifications Parameter Range/Explanation Transmit and Receive Frequency Range 2.4 - 2.5 GHz Effective Radiated Power <10 mW Modulation Direct Sequence Spread Spectrum per IEEE 802.15.4-2006 Protocol Proprietary Frequency Hopping Communication Protocol FCC Compliance 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. Pursuant to FCC 15.21 of the FCC rules, changes not expressly approved by Mobius Bionics might cause harmful interference and void the FCC authorization to operate this product. This product complies with FCC OET Bulletin 65 radiation exposure limits set forth for an uncontrolled environment. Effective Range (Arm/IMU) 3 m or less Effective Range (Arm/Dongle) 1 m or less Wireless Security Proprietary Frequency Hopping Communication Protocol Rev 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document 12/5/16115 Appendix A: Technical Specifications Table 34. Arm Radio Specifications (Continued) Parameter Range/Explanation Quality of Service Provisions Interruption or corruption of communication between the Arm and IMUs can lead to interruptions in arm motion. Interruption of communication for more than 2 seconds may lead to the system reverting to Standby mode. Interruption of communication for more than 8 seconds results in the system declaring a fault. Common consumer electronic devices that transmit in the same frequency band used by the LUKE arm system may prevent the Arm and IMUs from communicating. Microwave ovens, Bluetooth® devices, Wi-Fi® networks and 2.4 GHz cordless phones, when transmitting or receiving, can cause interruption of communication between the Arm and IMUs. During testing, the LUKE arm system experienced occasional communication interruptions in the presence of Bluetooth mice. It is likely that other devices operating in similar frequency ranges can have a similar effect. This interference, however, will not cause any incorrect data to be sent and will not cause any harm to the LUKE arm system. Some metal detectors and anti-theft detection systems at store exits transmit in the same frequency band used by the LUKE arm system. These devices can cause interruption of communication between the Arm and IMUs. Again, this interference will not cause any incorrect data to be sent and will not cause any harm to the LUKE arm system. In each of these cases, communication problems can usually be resolved by turning off or moving away from other RF transmitting devices. 116 Use or Disclosure of Data Contained on this Page is Subject to the Restrictions on the Inside Title Page of this Document -- Rev 1.8 B Guidance and Manufacturer’s Declaration This Appendix details information on the electromagnetic environment and recommended spacing between portable and mobile RF communications equipment (transmitters) and the LUKE arm system. Electromagnetic Environment The LUKE arm system is intended for use in the electromagnetic environment specified in Table 35 and Table 36. The user of the LUKE arm system should assure that it is used in such an environment. Electromagnetic Emissions Table 35. Guidance and Manufacturer’s Declaration - Electromagnetic Emissions Emissions Test RF emissions Compliance Group 1 The LUKE arm system 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. Class B The LUKE arm system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. CISPR 11 RF emissions CISPR 11 Electromagnetic Environment - Guidance Rev. 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 117 Appendix B: Guidance and Manufacturer’s Declaration Electromagnetic Immunity Table 36. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test Electrostatic discharge (ESD) IEC 60601 Test Level Compliance Level +/- 6 kV contact +/- 6 kV contact +/- 8 kV air +/- 8 kV air Electrical fast transient/burst +/- 2 kV for power +/- 2 kV for power supply lines supply lines IEC 61000-4-4 +/- 1 kV for input/output +/- 1 kV for input/output lines lines Surge +/- 1 kV line(s) to +/- 1 kV line(s) to IEC 61000-4-5 line(s) line(s) +/- 2 kV line(s) to earth +/- 2 kV line(s) to earth <5% UT <5% UT (>95% dip in UT) (>95% dip in UT) for 0,5 cycle for 0,5 cycle 40% UT 40% UT (60% dip in UT) (60% dip in UT) for 5 cycles for 5 cycles 70% UT 70% UT (30% dip in UT) (30% dip in UT) for 25 cycles for 25 cycles <5% UT <5% UT (>95% dip in UT) (>95% dip in UT) for 5 s for 5 s 3 A/m 3 A/m IEC 61000-4-2 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 Electromagnetic Environment - Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the LUKE arm system requires continued operation during power mains interruptions, it is recommended that the LUKE arm system be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. 118 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.8 Electromagnetic Environment Table 36. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the LUKE arm system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance: Conducted RF 3 Vrms 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz Radiated RF 3 V/m 10 V/m IEC 61000-4-3 80 MHz to 2.5 GHz 26 MHz to 80 MHz (continued on next page) 3 V/m d = 1.2 P d = 0.35 P d = 1.2 P 80 MHz to 460 MHz 10 V/m d = 0.35 P 460 MHz to 470 MHz 3 V/m d = 1.2 P 470 MHz to 690 MHz 20 V/m d = 0.18 P 690 MHz to 800MHz 20 V/m d = 0.35 P 800MHz to 965 MHz (continued on next page) where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Rev. 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 119 Appendix B: Guidance and Manufacturer’s Declaration Table 36. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Radiated RF 3 V/m 3 V/m IEC 61000-4-3 80 MHz to 2.5 GHz 965MHz to 1.39 GHz Electromagnetic Environment - Guidance d = 2.3 P (continued) 20 V/m d = 0.35 P 1.39 GHz to 6.0 GHz Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: Magnetic Fields generated by: N/A 0.1 kHz - 3.5 kHz 300 A/m No special precautions required. • Metal Detectors 10 kHz - 60 kHz • EAS Systems and Tag Deactivators (No Standard Applied) 50 A/m 50 kHz - 150 kHz 30 A/m NOTE 1: At 80 MHz, 460 MHz, 470 MHz, 690 MHz, 800 MHz, 965 MHz, and 1.39 GHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LUKE arm system is used exceeds the applicable RF compliance level above, the LUKE arm system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the LUKE arm system. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 120 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.8 Recommended Separation Distances Recommended Separation Distances The LUKE arm system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the LUKE arm system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LUKE arm system as recommended below, according to the maximum output power of the communications equipment. Table 37 and Table 38 defines the recommended separation distances between portable and mobile RF communications equipment and the LUKE arm system. Table 37. Recommended Separation Distances (Part I) Rated Maximum Output Power of Transmitter Separation Distance According to Frequency of Transmitter 150 kHz 80 MHz 26 MHz 80 MHz 80 MHz 460 MHz 460 MHz 470 MHz 470 MHz 690 MHz d = 1.2 P d = 0.35 P d = 1.2 P d = 0.35 P d = 1.2 P 0.01 0.12 0.035 0.12 0.035 0.12 0.1 0.37 0.11 0.37 0.11 0.37 1.2 0.35 1.2 0.35 1.2 10 3.7 1.1 3.7 1.1 3.7 100 12 3.5 12 3.5 12 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz, 460 MHz, 470 MHz, 690 MHz, 800 MHz, 965 MHz, and 1.39 GHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Rev. 1.8 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 121 Appendix B: Guidance and Manufacturer’s Declaration Table 38. Recommended Separation Distances (Part II) Rated Maximum Output Power of Transmitter Separation Distance According to Frequency of Transmitter 690 MHz 800 MHz 800 MHz 965 MHz 965 MHz 1.390 GHz 1.390 GHz 6.0 GHz d = 0.18 P d = 0.35 P d = 2.3 P d = 0.35 P 0.01 0.018 0.035 0.23 0.035 0.1 0.055 0.11 0.74 0.11 0.18 0.35 2.3 0.35 10 0.55 1.1 7.4 1.1 100 1.8 3.5 23 3.5 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz, 460 MHz, 470 MHz, 690 MHz, 800 MHz, 965 MHz, and 1.39 GHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Essential Performance The following items are the Essential Performance of the LUKE arm system. The LUKE arm system: 122 • is able to safely power on and off. • enters Standby mode at power on. • hand open button operates normally. • gross motor movements are slowed within the slowdown region. • low battery alert operates normally. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.8 LUKE Arm Prosthetist Reference Guide Part Number: LU-09015-001 Revision: 1.5 Date: December 05, 2016 Manufactured by: Mobius Bionics 470 Commercial Street Manchester, NH 03101 www.mobiusbionics.com Copyright Copyright © 2016. Mobius Bionics LLC. All rights reserved. Mobius Bionics LLC. (Mobius) proprietary rights are included herein. This document contains Mobius confidential information and may not be copied, transferred, or disclosed except as authorized by Mobius. Trademarks Bluetooth® is a registered trademark of Bluetooth SIG. Wi-Fi® is a registered trademark of Wi-Fi Alliance. Windows® is a registered trademark of Microsoft Corporation. Contents Contents About This Guide Intended Audience ....................................................................................... How to Use This Guide ................................................................................ Conventions ................................................................................................ Terminology................................................................................................ Acronyms ................................................................................................... Contacting Technical Support ....................................................................... Chapter 1 Overview The Client ................................................................................................... Indications For Use................................................................................. Contraindications For Use....................................................................... LUKE Arm System ...................................................................................... Arm Configurations................................................................................ Shoulder Configuration (SC) .............................................................. Humeral Configuration (HC).............................................................. Radial Configuration (RC).................................................................. Batteries................................................................................................ Internal Battery ................................................................................ External Battery ............................................................................... External Battery Holster.......................................................................... Battery Chargers and Charging Dock....................................................... AC Adapter ..................................................................................... Charging Pad ................................................................................... Charging Dock................................................................................. ACI (Arm Control Interface) Modules ....................................................... Input/Output Control Devices ................................................................. The Fitting Arm ..................................................................................... Chapter 2 17 18 20 22 23 24 27 28 28 29 30 30 30 30 32 32 33 34 35 35 36 36 37 38 38 Safety Safety Guidelines - Arm ................................................................................ 39 Electromagnetic Interference (EMI) Safety....................................................... 45 Safety Guidelines - Battery ............................................................................ 45 Chapter 3 User Inputs/Outputs and the Control Scheme Arm Controls — Switching vs. Motion ........................................................... User Inputs.................................................................................................. IMUs (Inertial Measurement Units) ........................................................... Description ...................................................................................... Places Used ..................................................................................... Arm Controls ................................................................................... How They Are Used ......................................................................... Restrictions ...................................................................................... EMG - Electromyography (Surface EMG Electrodes) ................................. Description ...................................................................................... Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 47 48 48 48 49 49 49 49 50 50 Contents Places Used ..................................................................................... Arm Controls ................................................................................... How They Are Used ......................................................................... Restrictions ...................................................................................... Pressure Switches................................................................................... Description ...................................................................................... Places Used ..................................................................................... Arm Controls ................................................................................... How They Are Used ......................................................................... Restrictions ...................................................................................... Rocker Switches..................................................................................... Description ...................................................................................... Places Used ..................................................................................... Arm Controls ................................................................................... How They Are Used ......................................................................... Restrictions ...................................................................................... Pressure Transducers.............................................................................. Description ...................................................................................... Places Used ..................................................................................... Arm Controls ................................................................................... How They Are Used ......................................................................... Restrictions ...................................................................................... Linear Transducers................................................................................. Description ...................................................................................... Places Used ..................................................................................... Control Types .................................................................................. How They Are Used ......................................................................... Restrictions ...................................................................................... User Output - Tactor .................................................................................... Chapter 4 Battery Types and User Controls System Battery Types................................................................................... User Controls and Wrist Display.................................................................... Power ON/OFF Button Location............................................................. Turning the Arm ON and OFF ................................................................ Wrist Display ......................................................................................... Low Battery Icon and Low Battery Alert ......................................... System Fault Icon .......................................................................... Arm Mode LED and Grip Select LEDs ............................................ Display Button ................................................................................. Displaying the Battery Charge Level................................................... Changing the Display Brightness........................................................ Swapping IMUs................................................................................ IMU LED Status ..................................................................................... Hand Open Button................................................................................. Orienting The Arm While Pressing The Hand Open Button ................. Arm System and Wrist Display Button Durability............................................. 50 50 50 50 51 51 51 51 51 51 52 52 52 52 52 52 53 53 53 53 53 53 54 54 54 54 54 54 55 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 57 59 59 61 61 62 62 63 64 64 65 65 66 68 69 70 -- Rev. 1.5 Contents Chapter 5 Arm System Installation and Setup Installation and Setup Overview..................................................................... 73 Chapter 6 Fabricating the Socket System and Mounting the Arm The Fitting Arm ........................................................................................... 76 Adjusting the Fitting Arm ........................................................................ 77 Modifying the Fitting Arm for a Specific Configuration .............................. 78 Socket System and Arm Mounting Overview .................................................. 79 Mounting the Arm ....................................................................................... 80 Mounting Point of View .......................................................................... 80 Mounting the RC (Radial Configuration) Arm ................................................. 81 Installing and Connecting the RC Cable ................................................... 84 Tightening the Cable Connections to the Radial Interface Box.................... 88 Mounting the RC Arm ............................................................................ 89 Mounting the HC (Humeral Configuration) Arm ............................................. 91 Mounting the HC Cable .................................................................... 94 Mounting the SC (Shoulder Configuration) Arm.............................................. 96 SC Bend Bracket Mounting..................................................................... 96 Attaching the Fitting Arm ..................................................................... 101 Laminating the SC Socket Adapter ........................................................ 102 Mounting the SC Arm .......................................................................... 103 Sealing of the Shoulder Bellows ....................................................... 103 Attaching the SC Arm .................................................................... 104 Configuring the Shoulder’s Neutral Position ...................................... 106 Mounting the SC Cable................................................................... 106 Chapter 7 Installing/Connecting ACI Modules and User Inputs ACI (Arm Control Interface) Module Overview .............................................. Locating ACI Modules ............................................................................... Mounting the ACI Module........................................................................... Screwing the Module to the Socket .................................................. Laminating the ACI Module to the Socket ........................................ Attaching the Module Using Hook and Loop Fasteners...................... Attaching the Module Using Mounting Loops.................................... Connecting the ACI Module, User Inputs and Tactor..................................... Connecting the Power and Communications Line ................................... Connecting User Inputs ........................................................................ Connecting User Inputs - Surface EMG Electrodes .................................. Connecting the Tactor.......................................................................... Tightening the Cable Connections to the ACI ......................................... Securing the ACI Cables ....................................................................... Assigning an ACI Module ID ....................................................................... Chapter 8 108 108 108 108 108 109 109 109 110 111 112 113 114 115 115 Installing IMUs Installing the IMU in the Shoe Clip .............................................................. 118 Installing the IMU/Shoe Clip on the Client’s Shoe ........................................ 120 Waking a Sleeping IMU .............................................................................. 121 Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document Contents Chapter 9 Installing, Connecting, and Charging the System Batteries Battery Charging Safety ............................................................................. Connecting the External Battery Holster to the Arm ..................................... Disconnecting the External Battery Extension Cable...................................... Testing and Charging the Batteries .............................................................. Testing the Internal Battery Charge Level ............................................... Charging the Internal Battery ................................................................ Testing the External Battery Charge Level .............................................. Charging the External Battery ............................................................... Removing the External Battery from the Holster ............................... Installing the External Battery in the Holster...................................... Testing the IMU Battery Charge Level ................................................... Charging the IMU Battery ..................................................................... Chapter 10 Key Concepts and Operating Modes Motion vs. Switching .................................................................................. Operating Modes ....................................................................................... IMU - Walk Detect................................................................................ IMU - Angle Limit Detect ...................................................................... Mode Change Interlock......................................................................... Zeroing the IMUs ................................................................................. Operating Modes and Motions .................................................................... Standby Mode (No Motion) ................................................................... Hand Mode Motions............................................................................. Opening or Closing the Hand.......................................................... Compound Wrist Motions ............................................................... Rotating the Wrist .......................................................................... Selecting a Grip ................................................................................... Power Grip (Grip Select LED 1)....................................................... Tool Grip (Grip Select LED 2) ......................................................... Fine Pinch Closed Grip (Grip Select LED 3) ...................................... Fine Pinch Open Grip (Grip Select LED 4)........................................ Lateral Pinch Grip (Grip Select LED 5) ............................................. Chuck Grip (Grip Select LED 6)....................................................... Grip Detents .................................................................................. Arm Mode Motions .................................................................................... SC Arm Motions .................................................................................. Moving the Hand Up or Down (SC Arm) .......................................... Moving the Hand Left or Right (SC Arm).......................................... Moving the Hand Forward or Backward (SC Arm) ............................. Voluntary Elbow Positioning - Medial/Lateral (SC Arm) ..................... HC Arm Motions ....................................................................................... Elbow Flexion - Extension (HC Arm) ...................................................... Humeral Internal - External Rotation (HC Arm)....................................... Chapter 11 124 125 126 126 127 127 129 130 133 133 134 134 139 140 141 141 142 142 143 143 143 144 144 146 146 147 148 149 149 150 152 152 153 153 154 154 155 155 156 156 157 Configuring the Arm Using the Prosthetist Interface Installing the Prosthetist Interface ................................................................ 159 Installing the Prosthetist Interface Software............................................. 159 Installing the FTDI (Windows) Drivers ..................................................... 161 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Contents If Connected to the Internet............................................................. If NOT Connected to the Internet .................................................... Opening the Prosthetist Interface ................................................................ Navigating The Prosthetist Interface............................................................. Arm PI Menus...................................................................................... Settings Menu ................................................................................ Configuration Menu........................................................................ Configuration Steps and Dynamic Configuration Screen .......................... Update Arm ........................................................................................ Save Configuration to File..................................................................... Virtual Reality Environment................................................................... View Input Signals................................................................................ Status.................................................................................................. Arm Illustration .................................................................................... Tool Tips............................................................................................. Using the Prosthetist Interface..................................................................... STEP 1: Discover and Select Master Arm Controller (MAC)........................... Discovering and Selecting the MAC ....................................................... STEP 2: Client Configuration...................................................................... Initial Configuration ........................................................................ Existing Configurations ................................................................... Create a New Configuration.................................................................. Select the Arm Assembly ...................................................................... Zero the Shoulder (if fitting an SC arm) .................................................. Clear the Arm Configuration ................................................................. Read the Current Configuration from the Arm........................................ Load a Configuration from File.............................................................. STEP 3: Configure ACI Modules ................................................................. Wired ACIs .................................................................................... Wireless IMUs ................................................................................ Configuring a New ACI for the First Time......................................... Understanding Thresholds and Gains ........................................................... Thresholds........................................................................................... Gains .................................................................................................. Setting Joint or Motion Speed Limits........................................................... Input Gains.......................................................................................... Input Thresholds .................................................................................. Output Gains ....................................................................................... Step 4: Configure Inputs ............................................................................ Step 5: Configure Arm Actions ................................................................... Selecting and Activating an Action......................................................... Configuration Screens - Arm Actions ............................................... Tool Tips and Keyboard Shortcuts............................................................... What’s Next .............................................................................................. Chapter 12 161 162 166 167 167 167 169 173 173 174 175 175 176 176 177 177 178 179 179 179 180 181 182 182 183 184 185 185 187 187 187 190 190 190 190 191 191 191 192 196 199 199 202 202 Virtual Reality Environment and Viewing Input Signals Using the Virtual Reality Environment.......................................................... Controlling the VRE Image ......................................................................... Viewing Input Signals ................................................................................. Troubleshooting Connection Problems......................................................... What’s Next .............................................................................................. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 203 207 208 208 208 Contents Chapter 13 Using the Arm Safe Operation of the System ..................................................................... What To Do If the Arm Is Not In Proper Working Order.......................... Arm Is Not in Proper Working Order ............................................... Unsure When Using the Arm........................................................... Releasing the Hand/Arm Using the Hand Open Button..................... Doffing the Arm ............................................................................. Safe Motions ....................................................................................... Taking It Slow...................................................................................... Practicing Safe Operation of the System ................................................ Carrying Heavy Objects ........................................................................ Initializing the Arm..................................................................................... Re-Initializing the Arm ................................................................................ Improper Shutdowns.................................................................................. LUKE Arm User Guide............................................................................... What’s Next .............................................................................................. Chapter 14 Maintaining and Troubleshooting the Arm Maintaining the Arm .................................................................................. Removing and Replacing the Fingernails, Finger Covers and Hand Cover . Removing and Replacing Fingernails ................................................ Removing and Replacing Finger Covers ........................................... Removing and Replacing Hand Cover .............................................. Cleaning the Arm................................................................................. Troubleshooting the Arm............................................................................ LUKE Arm System Alerts ..................................................................... Troubleshooting ................................................................................... Appendix A Prosthetist Checklist Appendix B Technical Specifications Arm Specifications ..................................................................................... Battery Specifications ................................................................................. AC Adapter Specifications .......................................................................... Charging Pad Specifications........................................................................ Arm Radio Specifications............................................................................ Appendix C 219 220 221 222 222 224 225 225 226 241 245 247 248 249 Manufacturers and Part Numbers LUKE Arms .............................................................................................. Hand and Finger Covers............................................................................. General Accessories ................................................................................... User Inputs................................................................................................ Optional Accessories .................................................................................. External Cables.......................................................................................... Socket Fabrication Components.................................................................. 211 211 212 212 212 213 213 214 214 215 215 216 216 217 217 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 251 252 253 254 254 255 256 -- Rev. 1.5 Contents Appendix D Guidance and Manufacturer’s Declaration Electromagnetic Environment...................................................................... Electromagnetic Emissions .................................................................... Electromagnetic Immunity..................................................................... Recommended Separation Distances ........................................................... Essential Performance ................................................................................ Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 257 257 258 261 262 Contents 10 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Contents List of Figures Figure 1. Figure 2. Figure 3. Figure 4. Figure 5. Figure 6. Figure 7. Figure 8. Figure 9. Figure 10. Figure 11. Figure 12. Figure 13. Figure 14. Figure 15. Figure 16. Figure 17. Figure 18. Figure 19. Figure 20. Figure 21. Figure 22. Figure 23. Figure 24. Figure 25. Figure 26. Figure 27. Figure 28. Figure 29. Figure 30. Figure 31. Figure 32. Figure 33. Figure 34. Figure 35. Figure 36. Figure 37. Figure 38. Figure 39. Figure 40. Figure 41. Figure 42. Figure 43. Arm Configurations................................................................ 31 Internal Battery/Power Interface Location ................................ 32 External Battery ..................................................................... 33 External Battery Holster.......................................................... 34 AC Adapter........................................................................... 35 Wireless Charging Pad for IMU Battery .................................... 36 Charging Dock ...................................................................... 36 ACI Module ........................................................................... 37 Pinch Point Areas .................................................................. 44 Inertial Measurement Unit....................................................... 48 Example Surface EMG Electrode ............................................. 50 Pressure Switches .................................................................. 51 Rocker Switches .................................................................... 52 Pressure Transducer ............................................................... 53 Linear Transducer .................................................................. 54 Tactor................................................................................... 55 Power Button and LED - SC, HC, and RC Arms With External Battery Only .......................................................................... 59 Power Button and LED - SC and HC Arms with Internal Battery 60 Wrist Display ......................................................................... 61 Hand Open Button ................................................................ 68 Arm and Wrist Display Button Durability .................................. 70 Fitting Arm............................................................................ 76 Adjusting the Fitting Arm for Range of Motion ......................... 77 Modifying the Fitting Arm for a Specific Configuration .............. 78 Point of View - Mounting the Arm ........................................... 80 RC Socket Adapter ................................................................ 81 R-TOP and L-TOP Mounting Reference Points and Cable Exit Port ...................................................................... 82 Left Hand RC Arm in Neutral Supination/Pronation Position .... 82 Orientation of Socket Adapter for Right Hand Arm or Left Hand Arm Mounting ....................................................................... 83 RC Cable .............................................................................. 84 Inserting the RC Cable Connector Through the Cable Exit Port . 85 Positioning the RC Cable Within the Socket Adapter ................ 85 Aligning the Raised Lip of the Over-Mold ................................. 86 Inserting the Over-Mold Into Place........................................... 86 Properly Seated Over-Mold ..................................................... 87 Installing and Connecting the Cables to Radial Interface Box...... 88 Tightening the Cable Connections to the Radial Interface Box ... 88 Identifying the Long Reference Mounting Pin - RC Arm ............ 89 RC Arm Attached to Socket Adapter ....................................... 90 HC Socket Adapter................................................................ 91 FRONT Mounting Reference Point - HC Socket Adapter........... 92 Identifying the Mounting Pins - HC Arm .................................. 93 HC Arm Attached to Socket Adapter....................................... 94 Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 11 Contents Figure 44. Figure 45. Figure 46. Figure 47. Figure 48. Figure 49. Figure 50. Figure 51. Figure 52. Figure 53. Figure 54. Figure 55. Figure 56. Figure 57. Figure 58. Figure 59. Figure 60. Figure 61. Figure 62. Figure 63. Figure 64. Figure 65. Figure 66. Figure 67. Figure 68. Figure 69. Figure 70. Figure 71. Figure 72. Figure 73. Figure 74. Figure 75. Figure 76. Figure 77. Figure 78. Figure 79. Figure 80. Figure 81. Figure 82. Figure 83. Figure 84. Figure 85. Figure 86. Figure 87. Figure 88. Figure 89. Figure 90. Figure 91. Figure 92. 12 Mounting the HC Cable.......................................................... 95 SC Bend Bracket ................................................................... 96 Attaching the Socket Adapter to the Bend Bracket.................... 97 Attaching the Form Shoulder to the Bend Bracket .................... 98 Aligning the Bend Bracket Perpendicular to Ground.................. 98 Aligning the Shoulder Flex Axis of Rotation.............................. 99 Shoulder Flexion Alignment Correction Indexing ...................... 99 Removing Excess Bend Bracket Legs ..................................... 100 Example Fitting Arm - Hand to Mouth Alignment ................... 101 Finished Laminated SC Socket Adapter ................................. 102 Sealing of the Shoulder Bellows............................................. 103 SC Arm Notch Orientation ................................................... 104 Attaching the SC Arm .......................................................... 105 SC Arm Attached to Socket .................................................. 105 Mounting the SC Cable ........................................................ 106 ACI Module - Power and Communications Line Connectors .... 110 ACI Module - User Input Connectors ..................................... 111 Example - Connecting the Pressure Transducer to the ACI Module ......................................................................... 112 EMG - Proper Alignment of Ribbon Cable To Electrode .......... 112 Connecting the Tactor to the ACI Module .............................. 113 Tightening the Cable Connections to the ACI ......................... 114 Attaching the IMU to the Shoe Clip ....................................... 119 Attaching the IMU/Shoe Clip to the Client’s Shoe .................. 120 Connecting the External Battery to the Arm Cable .................. 125 Disconnecting the External Battery Extension Cable ................ 126 Internal Battery Charging Port and Status Icon ....................... 128 Testing the External Battery Charge Level.............................. 129 External Battery Charging Dock and Status LEDs ................... 131 Removing and Replacing the External Battery ........................ 133 Charging the IMU Battery..................................................... 135 Hand Open and Hand Closed ............................................... 144 Compound Wrist Motions ..................................................... 145 Rotating the Wrist ................................................................ 146 Power Grip.......................................................................... 147 Tool Grip ............................................................................ 148 Fine Pinch Closed Grip......................................................... 149 Fine Pinch Open Grip .......................................................... 149 Lateral Pinch Grip................................................................ 151 Chuck Grip.......................................................................... 152 Moving the Hand Up or Down .............................................. 154 Moving the Hand Left or Right.............................................. 154 Moving the Hand Forward or Backward ................................. 155 Voluntary Elbow Positioning (VEP) ........................................ 156 Elbow Flexion - Extension ..................................................... 156 Humeral Internal - External Rotation...................................... 157 Welcome to the ARM PI Setup Wizard................................... 160 Select Installation Folder Screen ............................................ 160 Installing Device Driver Software ........................................... 161 Your Device Is Ready To Use................................................ 161 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Contents Figure 93. Figure 94. Figure 95. Figure 96. Figure 97. Figure 98. Figure 99. Figure 100. Figure 101. Figure 102. Figure 103. Figure 104. Figure 105. Figure 106. Figure 107. Figure 108. Figure 109. Figure 110. Figure 111. Figure 112. Figure 113. Figure 114. Figure 115. Figure 116. Figure 117. Figure 118. Figure 119. Figure 120. Figure 121. Figure 122. Figure 123. Figure 124. Figure 125. Figure 126. Figure 127. Figure 128. Figure 129. Figure 130. Figure 131. Figure 132. Figure 133. Figure 134. Figure 135. Figure 136. Figure 137. Figure 138. Figure 139. Figure 140. Device Driver Installation Status............................................. 162 Device Driver Software Not Successfully Installed .................... 162 Details - Device Driver Software Not Successfully Installed ....... 163 Update Driver Software ........................................................ 163 Browse for Folder ................................................................ 164 Update Driver Software - Unknown Device ............................ 164 Successful Driver Update ...................................................... 165 Prosthetist Interface Main/Welcome Screen ........................... 166 Arm PI Menus ..................................................................... 167 Power Save Mode ................................................................ 168 Real Time Clock .................................................................. 168 Print Summary Example ....................................................... 169 Print IMU Actions ................................................................ 170 Event Logs Example............................................................. 171 Usage Stats Example............................................................ 172 Configuration Steps and Configuration Screen ....................... 173 Save Configuration to File..................................................... 174 Power Cycle the Arm ........................................................... 174 Status ................................................................................. 176 Arm Illustration .................................................................... 176 Example - Tool Tip .............................................................. 177 Step 1: Discover and Select MAC.......................................... 178 Step 2 - Client Configuration ................................................ 180 Configuring the Shoulder’s Neutral Position............................ 183 Change to Current Configuration .......................................... 183 Save Config to File............................................................... 184 Saved Client Configuration Files ............................................ 185 Write Configuration to Arm .................................................. 185 Step 3: Configure ACI Modules............................................. 186 Configure Wired ACI Module ID............................................ 188 Successful Assignment of Wired ACI Device ........................... 188 Power Cycle the Arm ........................................................... 189 Step 4: Configure Inputs....................................................... 192 Activate/Zero IMUs.............................................................. 194 Step 5: Configure Arm Actions (SC Arm Shown).................... 196 Example Configure Action Screen - Toggle Grip Select ........... 200 Example - Tool Tip .............................................................. 202 Virtual Reality Environment and View Input Signals Buttons .... 204 Virtual Reality Environment................................................... 205 View Input Signals ............................................................... 208 Hand Open Button .............................................................. 213 Lateral Pinch Grip - Fully Open ............................................. 220 Removing and Replacing the Fingernails ................................ 221 Lace - Securing Hand Cover ................................................. 223 Removing and Replacing the Finger and Hand Covers ............ 224 Dimensions of Shoulder Configuration (In Centimeters) ........... 244 Dimensions of Humeral Configuration (In Centimeters)............ 244 Dimensions of Radial Configuration (In Centimeters) ............... 245 Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 13 Contents 14 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Contents List of Tables Table 1. Table 2. Table 3. Table 4. Table 5. Table 6. Table 7. Table 8. Table 9. Table 10. Table 11. Table 12. Table 13. Table 14. Table 15. Table 16. Table 17. Table 18. Table 19. Table 20. Table 21. Table 22. Table 23. Table 24. Table 25. Table 26. Table 27. Table 28. Table 29. Table 30. Table 31. Table 32. Table 33. Table 34. Table 35. Table 36. Table 37. Table 38. Table 39. Table 40. Table 41. Table 42. Table 43. Table 44. Table 45. Table 46. Table 47. Arm System Icons ................................................................. 20 Text Conventions.................................................................. 21 Terminology ......................................................................... 22 Acronyms............................................................................. 23 Arm Controls........................................................................ 47 Arm Configurations and Batteries........................................... 58 Arm Mode and Grip Select LEDs............................................ 63 Wrist Display Battery Charge Levels ....................................... 64 IMU LED Status.................................................................... 66 LUKE Arm System Installation and Setup Overview ................. 74 ACI Connection Types ........................................................ 109 Internal Battery Charging Port and Status Icon ...................... 128 External Battery Charge Level .............................................. 130 External Battery Charging Dock Status LEDs......................... 131 IMU Battery Charging Status LEDs....................................... 135 Control Types - Switching vs. Motion ................................... 139 Arm and Operating Modes................................................... 140 Hand Mode — Motions ....................................................... 143 Grip Select LEDs ................................................................ 146 Arm Mode — Motions......................................................... 153 Step 1: Discover and Select MAC - Fields and Buttons ........... 179 Step 2: Client Configuration - Fields and Buttons ................... 180 Arm Control Interface - Fields and Buttons ............................ 186 IMU Setup - Fields and Buttons ............................................ 193 Configurable Arm Actions.................................................... 197 Configure Actions Settings Glossary ..................................... 200 Virtual Reality Settings......................................................... 205 VRE Image Control Keys ..................................................... 207 Troubleshooting - Try This First............................................ 226 Troubleshooting - Wrist Display and System Faults ............ 227 Troubleshooting - Arm Function ...................................... 231 Troubleshooting - Power and Battery Charging ................. 232 Troubleshooting - Arm and PI Computer Communication .. 234 Arm System Specifications................................................... 241 Operating Environmental Range........................................... 242 Transport and Storage Environmental Range......................... 242 Service Life Specifications.................................................... 243 Mass of Arm Configurations................................................. 243 Dimensions of Arm Configurations ....................................... 243 Battery Charge and Operation Times.................................... 245 Power Specifications - Internal Battery .................................. 246 Power Specifications - External Battery ................................. 246 Power Specifications - IMU Battery....................................... 246 AC Adapter Specifications ................................................... 247 Charging Pad Specifications................................................. 248 Arm Radio Specifications..................................................... 249 LUKE Arm Manufacturers and Part Numbers ........................ 251 Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 15 Contents Table Table Table Table Table 48. 49. 50. 51. 52. Table 53. Table 54. Table 55. Table 56. Table 57. 16 Hand and Finger Cover Manufacturers and Part Numbers....... General Accessories Manufacturers and Part Numbers............ User Inputs Manufacturers and Part Numbers ........................ Optional Accessories Manufacturers and Part Numbers .......... External Cable Manufacturers, Part Numbers, and Maximum Length................................................................ Socket Fabrication Components ........................................... Guidance and Manufacturer’s Declaration Electromagnetic Emissions ................................................... Guidance and Manufacturer’s Declaration Electromagnetic Immunity.................................................... Recommended Separation Distances (Part I) .......................... Recommended Separation Distances (Part II) ......................... Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 252 253 254 254 255 256 257 258 261 262 -- Rev. 1.5 About This Guide This guide provides setup and configuration information for the LUKE arm and system components. This information includes step by step procedures on how to install, set up, and configure the arm as well as the system components. Also included is conceptual and operational information on the arm and system components which you and your client need to understand prior to setting up the arm and configuring the arm. This guide is shipped with the LUKE arm system. Intended Audience This guide is intended for prosthetists who will be setting up and configuring the arm to ensure safe and effective use of the arm. Read this guide carefully and be sure to follow all directions. At the end of this guide, there is a checklist. See Appendix A, “Prosthetist Checklist”. Prior to sending the client home with the LUKE arm system, complete this checklist to ensure the client is able to operate the arm appropriately. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document r17 About This Guide How to Use This Guide The following table summarizes the information in this guide. Read To Learn About... Section I — Arm System Overview Chapter 1, “Overview” Overview — Provides introductory information about the client needs as they relate to the LUKE arm and system components used to fit, set up, and configure the arm. Chapter 2, “Safety” Safety — Provides all safety WARNINGS, CAUTIONS, and notices you and your client must read prior to setting up and configuring the arm and system components. Chapter 3, “User Inputs/Outputs and the Control Scheme” Determining the Control Scheme — Provides information on the types of user inputs which you will use to determine the arm’s control scheme. Chapter 4, “Battery Types and User Controls” Arm Configurations — Provides information on the battery types used in specific arm configurations as well as information on the display and buttons used to control the arm. Section II — Mounting and Setting Up the Arm System Chapter 5, “Arm System Installation and Setup” Setting Up the LUKE Arm — Provides high-level steps you need to perform to install and set up the LUKE arm. These high-level steps are cross-referenced to specific chapters where detailed information is provided. Chapter 6, “Fabricating the Socket System and Mounting the Arm” Fabricating the Socket and Harness — Provides information about fabricating and building the socket as well as how to attach the arm types to the socket. Chapter 7, “Installing/Connecting ACI Modules and User Inputs” Installing and Connecting ACI Modules — Provides information on installing and connecting ACI Modules. Chapter 8, “Installing IMUs” Installing and Connecting the User Inputs — Provides information on connecting the user inputs to the ACI Modules. Chapter 9, “Installing, Connecting, and Charging the System Batteries” Selecting the Battery — Provides information on selecting the battery that will be used to power the arm. Section III — Configuring the Arm Chapter 10, “Key Concepts and Operating Modes” Understanding Arm Concepts — Provides conceptual and operational information about the arm. Chapter 11, “Configuring the Arm Using the Prosthetist Interface” Configuring the Arm Using Prosthetist Interface — Provides information on using the Prosthetist User Interface software to configure the arm. 18 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document --Rev. 1.5 How to Use This Guide Read To Learn About... Chapter 12, “Virtual Reality Environment and Viewing Input Signals” Virtual Reality Environment and Viewing Input Signals — Provides information on checking the arm configuration using the Virtual Reality Environment. Section IV — Using and Maintaining the Arm Chapter 13, “Using the Arm” Using the Arm — Provides information on how to use the arm in a safe manner. Also provides information on what to do if the arm is not working properly. Chapter 14, “Maintaining and Troubleshooting the Arm” Maintaining and Troubleshooting the Arm — Provides information on how to maintain the arm and perform basic troubleshooting steps to diagnose problems with the LUKE arm system. Section V— Appendices Appendix A, “Prosthetist Checklist” Prosthetist Checklist — Provides a checklist of items to review before allowing the client to use and take home the arm. Appendix B, “Technical Specifications.” Technical Specifications — Provides technical specifications for the arm and batteries. Appendix C, “Manufacturers and Part Numbers” Manufacturers and Part Numbers — Provides a list of manufacturers and part numbers for specific arm system parts. Appendix D, “Guidance and Manufacturer’s Declaration” Guidance and Manufacturers Declaration — Provides information on the electromagnetic environment and recommended spacing between portable and mobile RF communications equipment (transmitters) and the LUKE arm system. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 19 About This Guide Conventions Table 1 describes the Arm System icons and Table 2 describes text conventions used throughout this guide. Table 1. Arm System Icons Icon 20 Meaning Description Alert Alerts you and your client to potential injury hazards. Obey all safety messages that follow this symbol to avoid possible injury. Information Note Notice is used to address practices not related to personal injury. CAUTION Cautions indicate a hazardous situation which, if not avoided, could result in minor or moderate injury. WARNING Warnings indicate a hazardous situation which, if not avoided, could result in death or serious injury. Read This Guide Instructs you to refer to this guide prior to using the LUKE arm system. Electrically Isolated Equipment Indicates Type BF equipment which is electrically isolated and can safely contact a person’s skin without the risk of electric shock. Radio Transmitter Indicates that equipment contains a radio transmitter. Disposal of Equipment Indicates that equipment should not be disposed of in the trash. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document --Rev. 1.5 Conventions Icon Table 2. Meaning Description Recycle Equipment Indicates that equipment should be recycled. Use Indoors Identifies electrical equipment designed for indoor use and should be kept dry. Meets Class II Safety Requirements Identifies equipment that meets the safety requirements specified for Class II equipment according to IEC 61140. MR Unsafe Indicates that equipment is not compatible with magnetic resonance (MRI) environment. Text Conventions Convention Appearance in Text Example Key concepts and emphasized text Appear in bold type Inertial Measurement Unit User input Appears in bold courier typeface user input Screen display (Information that appears on your monitor) Appears in courier typeface screen display Book titles, directories, pathnames, and filenames Appear in italic typeface LUKE Arm Prosthetist Reference Guide Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 21 About This Guide Terminology The terminology used in this guide to describe the arm, socket, and accessories is described in Table 3. Table 3. Terminology Term 22 Description Arm Refers to the prosthetic arm only (no socket or accessories). Prosthesis Refers to the combination of the socket and the arm. Arm System Refers to the socket, arm, and all related accessories. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document --Rev. 1.5 Acronyms Acronyms See Table 4 for a list of acronyms used in this guide. Table 4. Acronyms Acronym Description ACI Arm Control Interface — Connects client input devices to the arm. EMG Electromyograph — A surface EMG electrode is a sensor placed on the skin that senses the activation signal of a muscle. EMI Electromagnetic Interference — Interference to the arm’s electronics caused by external electrical sources. HC Humeral Configuration— A type of arm configuration. IMU Inertial Measurement Unit — A control input that is placed on top of the client’s foot or lower appendage. LED Light Emitting Diode — A light that displays a status. MAC Master Arm Controller — The main processing unit of the LUKE arm. PI Prosthetist Interface — The user interface software used to configure a new arm or adjust the client’s current configuration. RC Radial Configuration — A type of arm configuration. USB Universal Serial Bus — A standard way for a computer to talk to other devices. VEP Voluntary Elbow Positioning — A type of arm motion of the LUKE arm. SC Shoulder Configuration — A type of arm configuration. VRE Virtual Reality Environment — Allows the client to practice using the arm with the selected control scheme. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 23 About This Guide Contacting Technical Support To contact technical support use the following address, web site URL or telephone: Mobius Bionics 470 Commercial Street Manchester, NH 03101 www.mobiusbionics.com 603-239-3834 855-MOBIUS1 (855-662-4871) 24 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document --Rev. 1.5 Section I — Arm System Overview This section provides an overview of the LUKE arm and system components. It defines all safety guidelines that you and your client must follow while setting up and configuring the arm. It provides information on user inputs and how you will use these inputs to determine the client’s control scheme used to control the arm. It also provides information on the correlation between the arm configurations and system components which you need to understand prior to setting up and configuring the arm. Chapters in this section include: • Chapter 1, “Overview” • Chapter 2, “Safety” • Chapter 3, “User Inputs/Outputs and the Control Scheme” • Chapter 4, “Battery Types and User Controls” Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 25 Section I — LUKE Arm Overview 26 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 1 Overview This chapter provides an overview defining the client needs as they relate to the LUKE arm and system components in order to fit, set up, and configure the arm. Topics in this chapter include: • The Client • LUKE Arm System The Client The first and foremost task in fitting, setting up, and configuring the arm is to meet with the client and determine their needs as they relate to the LUKE arm. As each client is different, you need to work with them to determine the appropriate arm configuration and system components that best fit them. You need to determine their physical and mental abilities as they relate to controlling and using the arm. Once you have determined the arm configuration and system components, you then need to examine the client and determine the type of socket and harness needed to securely attach the arm to them. Once you have determined the arm configuration and fabricated the socket and harness, you need to determine the input control scheme for the client. Again, as each client is different you need to work with them to determine the types of user inputs they can use in the control scheme in order to control the arm. Finally, you and/or a therapist should evaluate the strength and range of motion of the client as related to their prosthetic arm treatment and, if indicated, prescribe a home exercise program to address any limitations prior to the client engaging in active use of the prosthesis. This program could include exercises to strengthen the shoulder muscles including the rotator cuff, and the muscles of the upper arm if indicated. It is suggested that the client advance their activities with the LUKE arm on a gradual basis to minimize muscle soreness associated with using their new prosthesis. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 27 Chapter 1: Overview This initial meeting with the client to clearly define their physical and mental ability, the arm configuration, socket type and harness, user inputs, and to evaluate their strength and range of motion is a critical first step in the setup and configuration of the arm. Indications For Use The LUKE arm system consists of a prosthetic arm and accessories which are used by a certified prosthetist to create a full upper extremity prosthesis indicated for individuals, age 18 years and older, who have partial or full upper limb amputations or congenital defects. The device is used to assist in activities of daily living (ADLs). Contraindications For Use The LUKE arm system may only be fit by an accredited prosthetist experienced in the setup and configuration of powered prostheses. The following list of contraindications is included to provide guidelines for client evaluation/consideration. With clients having one or more of the conditions listed below, further evaluation/consideration may be required. The client’s healthcare providers should provide the final decision as to whether the client is suitable to use the prosthesis. Some clients may require more extended training or a longer period of time to adapt to using the device. Areas to consider in the evaluation of prosthesis suitability or which may require special consideration during the fitting of an arm system for a specific client include: 28 • Skin conditions of their residuum such as burns, poor skin coverage, and severe contractures that prevent current or prior wearing of a prosthetic arm. • Significant peripheral neuropathy, uncontrolled diabetes, inadequate extremity sensory perception, severe phantom pain or a history of skin ulcers. • Significant comorbidities which in the opinion of the clinician would interfere with the client’s ability to control the prosthesis. • Severe circulatory problems including peripheral vascular disease and pitting edema. • Clients undergoing chronic renal dialysis with co-morbidities associated with skin changes and poor wound healing deficits. • Communication deficits, neurocognitive deficits, or mental health problems that would limit their ability to properly learn and control the prosthesis. • Significant uncorrectable visual deficits that would impair the ability to see prosthesis movement, its controls or its indicators. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 LUKE Arm System Do not fit this system for a client unable to properly interpret your instructions or the LUKE Arm User Guide. In addition, the anatomy of the individual’s residuum may impact the suitability of the prosthesis, including excessive length – elbow disarticulation, wrist disarticulation and partial hand amputations, or inadequate residual limb length deficits may require further evaluation or special consideration. LUKE Arm System The LUKE arm is an upper-extremity prosthesis that accommodates Transradial through interscapulothoracic (including Shoulder Disarticulation and short Transhumeral) amputees. The arm provides a wide range of degrees of freedom and several control options for controlling arm movement. The LUKE arm is available in several different configurations and the system components used to support the arm are dependent on the arm’s configuration. One LUKE arm system may be used at a time by an individual. For each arm that is to be fit on a client Mobius Bionics offers all the materials, aside from 3rd party supplied input sensors, to configure the arm system. Materials that are typically used to fabricate sockets and fit conventional prosthetics are not supplied by Mobius Bionics. Depending on the client’s arm configuration you will need to order certain components from Mobius Bionics. Prior to setting up and configuring the arm you should review and understand the components available from Mobius Bionics. RISK OF DEATH OR SERIOUS HARM Do not disassemble or modify any of the provided modules. Do not connect any type of sensor not described in this guide without authorization of the manufacturer. Please connect and configure the LUKE arm system per instructions. Failure to do so could lead to injury. The LUKE arm configurations and system components are described in the following sections. • Arm Configurations • Batteries • External Battery Holster • Battery Chargers and Charging Dock • ACI (Arm Control Interface) Modules • Input/Output Control Devices • The Fitting Arm Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 29 Chapter 1: Overview Arm Configurations The arm is available in the three configurations listed below and shown in Figure 1. Once you have determined which arm configuration best fits your client’s needs, you need to specify if the arm is for the right or left side and the proper length as well as which battery type will power the arm. For more information on arm configurations and battery type used to power the arm see System Battery Types. Shoulder Configuration (SC) This arm is configured for those amputees with little or no residual limb or for those amputees with limited movement or other restricting factors in their residual limb. In most instances this arm configuration is powered by an internal battery located inside the forearm of the arm and with an external battery used to supplement power. Humeral Configuration (HC) This arm is configured for those amputees with a residual limb below the shoulder but not including the elbow. In most instances this arm configuration is powered by an internal battery located inside the forearm of the arm and with an external battery used to supplement power. Radial Configuration (RC) The radial configuration is the shortest of the three configurations and is for amputees with a residual limb below the elbow. Radial arm configurations are powered by the external battery. 30 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 LUKE Arm System Figure 1. Arm Configurations Shoulder Configuration (SC) Humeral Configuration (HC) Radial Configuration (RC) Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 31 3 User Inputs/Outputs and the Control Scheme Prior to setting up and configuring the arm you need to determine which types of user inputs the client can and will use to control the arm. To determine this control scheme, you and the client need to decide which types of inputs the client can physically operate in order to manage arm controls. This section provides information on the arm controls as well as the types of user inputs used to control the arm. Topics in this chapter include: • Arm Controls — Switching vs. Motion • User Inputs • User Output - Tactor Arm Controls — Switching vs. Motion User inputs are used to select the two arm controls, switching and motion. You need to identify and configure a specific user input to control switching of arm operating modes while configuring the remaining user inputs to control hand and arm motion. Table 5 lists the arm controls and provides a description of the control. Table 5. Arm Controls Arm Controls Description Switching A user input used to change or toggle through the operating modes: Standby mode, Hand mode, and Arm mode (if available). Motion A user input used to vary the speed and position of a joint or series of joints within the hand and arm. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 47 Chapter 3: User Inputs/Outputs and the Control Scheme User Inputs Listed below are the user inputs used to control the arm. Following the list is a description of each of the inputs, a description of how they are used, and any restrictions when using the inputs. • IMUs (Inertial Measurement Units) • EMG - Electromyography (Surface EMG Electrodes) • Pressure Switches • Rocker Switches • Pressure Transducers • Linear Transducers IMUs (Inertial Measurement Units) Description IMUs command motion by having the client tilt their foot to control the configured arm motions. See Figure 10. The IMUs have an IP57 rating. The IP rating specifies the strength of an enclosure against solids (such as dust) and liquids. An IP57 rating provides resistance to water at depths up to 1 m (39 inches) and resistance to fine dust. Figure 10. Inertial Measurement Unit Inertial Measurement Unit 48 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 User Inputs Places Used Inertial Measurement Units (IMUs) are installed on top of client’s shoes using a shoe clip or custom fabricated strap or pocket. For detailed information on installing and setting up the IMUs see Chapter 8, “Installing IMUs”. Arm Controls IMUs are used to control arm motion and certain switching functions other than mode select. See Restrictions below. How They Are Used If you intend to use IMUs, the first task you need to perform is to examine the client’s feet and decide if they can be used for viable control inputs. The client has to have the physical mobility to move their feet with enough dexterity to operate the IMU. The IMU designated for motion controls uses all four directions: anterior (toe), posterior (heel), medial (inside), and lateral (outside). You and the client determine which of these four motions are used to perform a specific arm motion. You configure this using the Prosthetist Interface (PI). When configuring the IMUs using the Prosthetist Interface you can adjust the output gains to vary the speed of the arm’s motion. The Prosthetist Interface allows you to configure up to two (2) sets of IMUs. The client is able to switch between sets. This is useful when an IMU battery runs low; the client can switch to the second set of IMUs while charging the first set. For instructions on switching between IMUs, see Swapping IMUs. The arm supports up to four IMU/ACI modules at a time in multiple combinations, with a maximum of 2 IMUs. For example, you may set up and configure the arm to support two IMU modules and two wired ACI modules or four wired ACI modules and no IMUs. Up to two pairs of IMUs can be assigned to an arm system, however only one pair may be used at a time. See Swapping IMUs for more information about switching between pairs of IMUs. Restrictions The IMUs CANNOT be used to control Switching (Mode Select) of the arm. The system will not allow Mode Select to be assigned to an IMU input. This is to eliminate the risk that the client can activate or deactivate the arm inadvertently through the simple act of walking. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 49 8 Installing IMUs Once the ACI Modules have been installed and connected you can then install the IMUs. The IMUs can be installed on a client's shoe or lower appendage using either the shoe clips or an alternate means such as custom straps or pockets in the shoe. There are two steps to install the IMUs on a shoe: attaching the shoe clip to the client’s shoe and attaching the IMU to the shoe clip. If your client needs help putting on and taking off the IMUs/shoe clips have the person who is providing the help available at this time. IMUs can be installed on a lower appendage by alternate means, as long as they are securely attached. If you create a label to indicate which IMU your client uses on the left or right side or to designate IMU sets, avoid covering the LED on the IMU. The IMUs will not provide data if tipped more than 83 degrees. Be sure to position the IMU as close to level as possible when installing the IMU. If you mount the IMU at an angle of more than 38 degrees to begin, the IMU will not provide the full range of +/- 45 degrees after zeroing because they are out of range when they reach the 83 degree limit. See IMU - Angle Limit Detect. Note that IMUs connect to the arm through a wireless connection. This wireless connection is configured through software using the Prosthetists Interface. See Chapter 11, “Configuring the Arm Using the Prosthetist Interface”. Topics in this chapter include: • Installing the IMU in the Shoe Clip • Installing the IMU/Shoe Clip on the Client’s Shoe Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 117 Chapter 8: Installing IMUs Installing the IMU in the Shoe Clip To install the IMU in the shoe clip, see Figure 65 and perform the following steps: 1. Slide the tabbed end of the IMU into the open end of the shoe clip. 2. Press down on the IMU until the shoe clip retention tab snaps into the IMU slot. Ensure the IMU is fastened securely to the shoe clip. 118 • The shoe clip can be put on the shoe either before or after the IMU is installed in the shoe clip. • You can attach the IMU by alternate means (straps/pocket/etc.) as long as it is securely attached. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Installing the IMU in the Shoe Clip Figure 65. Attaching the IMU to the Shoe Clip IMU Tab Open End of Shoe Clip Front Arrow Label Part 1 Press Down On IMU IMU Tab Part 2 Front Open End of Shoe Clip Part 3 Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 119 Chapter 8: Installing IMUs Installing the IMU/Shoe Clip on the Client’s Shoe To install the shoe clip on client’s shoe, see Figure 66 and perform the following steps: • Note that the shoe clip can be installed onto the shoe with the shoe on or off the client’s foot. • Once the shoe clip is installed, the shoe clip can remain on the shoe. • If the IMU is in the clip, make sure to attach the clip and IMU to the correct foot per the client's configuration. 1. Orient the shoe clip so that the open end of the clip is facing towards the client’s toes. 2. Slide the shoe clip under the laces of the shoe. When installing the shoe clip to the shoe, please ensure the following: • The shoe clip passes through at least two of the shoe’s laces to ensure the clip is secure and stable. • The Front Arrow label on the bottom of the IMU is facing towards the client’s toes. See Figure 65. 3. Tighten the laces to secure the IMU and shoe clip to the shoe. 4. If the client has not already done so, have them put on the shoe. Figure 66. Attaching the IMU/Shoe Clip to the Client’s Shoe Open End of Shoe Clip NOTE: IMU is Shown Attached to Shoe Clip. 120 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Waking a Sleeping IMU The wireless IMUs do not contain an ON/OFF button. An IMU that is awake and set up to communicate with an arm will do so once the arm is powered ON. See Waking a Sleeping IMU and Initializing the Arm. Waking a Sleeping IMU When an IMU has not communicated with the arm for more than 30 minutes, the IMU reverts to a sleep mode to conserve the battery. When in sleep mode the IMU is not listening for arm communication. As a result, if the IMU is in sleep mode when the arm is turned on, it will not connect with the arm. This results in a sweeping pattern on the Grip Select LEDs while the arm tries to connect with the IMUs. If the arm doesn’t connect with the IMUs after about 10 seconds, an “IMU Comm Lost” fault will occur. Having the client shake their foot with the IMU attached wakes the IMU from sleep mode so that the IMU is ready to communicate with the arm once the arm system is powered on. See Swapping IMUs for details on switching between sets of IMUs or Troubleshooting the Arm for troubleshooting information. An IMU that has been shaken awake is waiting to communicate with the arm. IMUs that are not actively communicating with an arm blink the battery state of charge LED whenever they are shaken, regardless of whether they are sleeping or not. After shaking the IMU awake if it does not communicate with the arm within five (5) minutes the IMU reverts back to sleep mode to conserve the battery charge. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 121 Chapter 8: Installing IMUs 122 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 11 Configuring the Arm Using the Prosthetist Interface The Prosthetist Interface (PI) is a graphical user interface used to configure the LUKE arm. This user interface allows you to collect and display real-time data from the arm and stores this data as specific arm configurations. The Prosthetist Interface obtains this information by communicating with the arm’s MAC (Master Arm Controller) via a wireless connection. Installing the Prosthetist Interface The Prosthetist Interface (PI) software is provided on several types of media. The first time you want to use the Prosthetist Interface on your computer, you need to install the PI software and FTDI (Windows) drivers onto the computer. If the Prosthetist Interface has already been installed on this PC, you must uninstall the program prior to reinstallation. Click Start ->Programs and Features ->Select “Arm PI” ->Choose uninstall Installing the Prosthetist Interface Software To install the PI software perform the following steps: The system requirements for the computer are as follows: • Windows® 7 • USB 2.0 Capability 1. Insert the PI media onto your computer. 2. Open the drive where the Arm PI Install resides. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 159 Chapter 11: Configuring the Arm Using the Prosthetist Interface 3. Double-click the Arm PI setup file. The Welcome to the Arm PI Setup Wizard window opens. See Figure 89. Figure 89. Welcome to the ARM PI Setup Wizard 4. Click Next. The Select Installation Folder screen appears. See Figure 90. Figure 90. Select Installation Folder Screen 5. You can choose to install the Arm PI in the default directory or browse to a directory of your choice. 6. Click Next twice. The Arm PI is installed. 7. Once the Arm PI installation is complete, click the Close button. 160 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Installing the Prosthetist Interface 8. Next, install the FTDI (Windows) drivers. See Installing the FTDI (Windows) Drivers. Installing the FTDI (Windows) Drivers The following sections provide information on how to install the FTDI (Windows) drivers depending if the computer is connected to or not connected to the internet. If Connected to the Internet When inserting the Mobius Bionics supplied PC dongle into the computer for the first time, the driver software automatically starts installing. To install the driver software, when connected to the internet, perform the following steps: 1. Insert the PC dongle into a USB port on your computer. Two pop-ups will appear in the following order on the bottom right of the desktop: a. Installing device driver software. See Figure 91. Figure 91. Installing Device Driver Software b. Your device is ready to use. See Figure 92. Figure 92. Your Device Is Ready To Use For details on the status of the installation, click on either of the pop-ups (shown in Figures 90 and 91) to make the Driver Software Installation window appear. See Figure 93. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 161 Chapter 11: Configuring the Arm Using the Prosthetist Interface Figure 93. Device Driver Installation Status 2. Once the device software installation is complete, restart your computer if instructed to do so. The Prosthetist Interface and drivers are now installed on your computer and an Arm PI Icon is displayed on the desktop. You can now begin to use the Prosthetist Interface. See Opening the Prosthetist Interface. If NOT Connected to the Internet If the computer is not connected to the internet, you need to manually link the FTDI (Windows) drivers (Serial Converter and Serial Port) that were installed during the installation of the PI. To link to the drivers, perform the following steps: 1. Insert the Mobius Bionics supplied PC dongle into a USB port on the computer. A pop-up appears notifying you that the Device driver software was not successfully installed. See Figure 94. Figure 94. Device Driver Software Not Successfully Installed For details on the status of the installation, click on the pop-up (shown in Figure 93) to make the Driver Software Installation window appear. See Figure 95. 162 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Installing the Prosthetist Interface Figure 95. Details - Device Driver Software Not Successfully Installed 2. Click Start ->Device Manager. 3. Under Other Devices, right click on the Unknown Device icon and choose Update Driver Software. The Update Driver Software window appears. See Figure 96. Figure 96. Update Driver Software 4. Click Browse my computer for driver software. The Browse For Folder window appears. See Figure 97. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 163 Chapter 11: Configuring the Arm Using the Prosthetist Interface Figure 97. Browse for Folder 5. Navigate to C:\Program Files(x86)\Mobius Bionics\Arm PI. 6. Select FTDI driver and click OK. The Update Driver Software - Unknown Device window appears. See Figure 98. Figure 98. Update Driver Software - Unknown Device 7. Verify that Include subfolders is checked. 8. Click Next. A message appears stating Windows has successfully updated your driver software. See Figure 99. 164 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Installing the Prosthetist Interface For the driver software update to take effect you need to restart your computer. Figure 99. Successful Driver Update 9. Click Close. 10.Repeat Steps 2 through 9 if: Depending on the Microsoft updater configuration of the PC, the device may first install the “USB Serial Converter” and read as “USB Serial Port” under “Other Devices”. Repeat Steps 2 through 9 so the “USB Serial Port” appears as “USB Serial Port (COM#)” under “PORTS” in the device manager. The Prosthetist Interface and drivers are now installed on your computer and an Arm PI icon is displayed on the desktop. You can now begin to use the Prosthetist Interface. See Opening the Prosthetist Interface. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 165 Chapter 11: Configuring the Arm Using the Prosthetist Interface Opening the Prosthetist Interface 1. Insert the PC Dongle into a USB port of your computer (if there isn't one already there). 2. Double click the Arm PI icon. The PI Welcome screen appears. See Figure 100. Figure 100. Prosthetist Interface Main/Welcome Screen 166 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Navigating The Prosthetist Interface Navigating The Prosthetist Interface The Prosthetist Interface (PI) contains PI menus, several buttons, and a configuration screen used to configure the arm. These items are described in the following sections. Arm PI Menus The PI menu has three drop down selections which allow you to change settings, view and print the configuration summary as well as events and statistics, and view the version of the PI. Figure 101. Arm PI Menus Settings Menu The Settings drop down menu contains three selections: • Change Settings • Power Save Mode • Real Time Clock Change Settings Change Settings allows you to manually change the Command Port and Data Port settings, if necessary. Note that the Command Port and Data Port are automatically detected during installation of the PI. Power Save Mode Power Save Mode configures the arm to engage the brakes when the arm stops moving. Engaging the brakes saves battery power by not running the motors. Power Save Mode is not used for RC arms. The Power Save Mode value is not cleared or saved with the PI arm configuration. You can set the delay, in seconds, between when the arm stops moving and when the brakes engage. With a delay of zero (0) seconds, Power Save Mode is turned OFF. When Power Save Mode is OFF, the brakes are disengaged and the motors are on whenever the arm is on. To set the Power Save Mode perform the following steps: 1. From the Settings menu select Power Save Mode. The Power Save Mode screen opens. See Figure 102. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 167 Chapter 11: Configuring the Arm Using the Prosthetist Interface Figure 102. Power Save Mode 2. Enter the new delay value (in seconds), and click Update Arm with New Delay. 3. Click Done. Real Time Clock Selecting the Real Time Clock function sends the computer’s clock settings to the arm system. This sets the arm's clock. The arm's clock is set at the factory. The arm’s clock is used to put a time stamp on the event log. The factory sets the arm's clock to Eastern time, and the clock does not automatically adjust for daylight savings time. To get or set the Real Time Clock perform the following steps: 1. From the Settings menu select Real Time Clock. The Real Time Clock screen opens. See Figure 103. Figure 103. Real Time Clock 2. To get the arm’s current clock setting, click Get Real Time Clock. 3. To send the computer’s clock settings to the arm, click Set Real Time Clock. 4. Click OK. 168 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Navigating The Prosthetist Interface Configuration Menu The Configuration drop down menu contains four selections. • Print Summary • Print IMU Actions • View Events • View Usage Stats Print Summary Print Summary allows you to view and print a summary of the arm configuration. To view or print the arm configuration summary perform the following steps: 1. From the Configuration menu select Print Summary. The Print Summary screen opens. See Figure 104. Figure 104. Print Summary Example Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 169 Chapter 11: Configuring the Arm Using the Prosthetist Interface 2. To print the summary configuration click Print. The Print dialog box opens. 3. Select the appropriate printer from the drop down list. 4. Click OK. Print IMU Actions After configuring the IMUs to perform certain arm actions, use the Print IMU Actions function to print out a single sheet reference card for the client. The card will show both IMUs and which actions they perform. The arrow points to the direction in which the client tilts their foot. To view or print the IMU configuration perform the following steps: 1. From the Configuration menu select Print IMU Actions. The Print IMU Actions screen opens. See Figure 105. Figure 105. Print IMU Actions 2. To print the IMU Actions click Print. The Print dialog box opens. 3. Select the appropriate printer from the drop down list. 4. Click OK. 170 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Navigating The Prosthetist Interface View Events View Events allows you to view a list of events that have occurred within the arm. Events include faults that have occurred and can be used for troubleshooting. See LUKE Arm System Alerts for more information. To view events perform the following steps: 1. From the Configuration menu select View Events. The Event Logs screen opens. See Figure 106. Figure 106. Event Logs Example 2. View events as needed to aid in troubleshooting. 3. To save the Event Logs to a file click Save Events. 4. When done viewing the Event Logs click Done. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 171 Chapter 11: Configuring the Arm Using the Prosthetist Interface View Usage Stats View Usage Stats allows you to view a list of arm usage statistics. To view statistics perform the following steps: 1. From the Configuration menu select View Usage Stats. The Usage Statistics screen opens. See Figure 107. Figure 107. Usage Stats Example 2. View the usage statistics as needed. 3. To save the Usage Stats to a file click Save Stats. 4. When done viewing the statistics click Done. 172 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Navigating The Prosthetist Interface Help Menu The Help drop down menu contains one selection: About. Selecting About opens the About PI dialog box which provides the PI version and copyright information. Configuration Steps and Dynamic Configuration Screen The PI contains five configuration steps located to the left of the Dynamic Configuration screen. Clicking on any of the steps opens the configuration screen for that step. If you are performing the initial configuration of the arm these five steps should be performed in sequential order. If you are changing an existing configuration you can click on the specific step you need to change. Figure 108. Configuration Steps and Configuration Screen Configuration Steps 1 - 5 Update Arm When you use the PI to make changes to a client configuration, at first these changes are only made on the computer. Clicking on the Update Arm button sends the client configuration information from PI to the arm. As you make changes to a client configuration in the PI, the Update Arm button pulses blue to notify you that the configuration needs to be sent to the arm. When updating the arm, you have the option to save the configuration to a file. To update the arm with the client configuration from PI and save the configuration to a file, perform the following steps: Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 173 Chapter 11: Configuring the Arm Using the Prosthetist Interface 1. Click the Update Arm button. The Save Configuration to File dialog box opens. See Figure 109. Figure 109. Save Configuration to File 2. To update the arm and save the configuration changes to a file click Yes. If you click No to save the current configuration to file, the configuration file will still be sent to the arm. IMPORTANT: Changes made to configuration settings in PI are not sent to the arm until you click the Update Arm button. 3. If prompted, power cycle the arm. See Figure 110. Figure 110. Power Cycle the Arm Power cycling is only needed after changes are made to the ACI module configuration. See STEP 3: Configure ACI Modules. Save Configuration to File Clicking the Save Configuration to File button at any time saves the client configuration to a file. Saving the configuration to a file does not update the arm. For information on sending a client configuration from the PI to the arm, see Update Arm. To save the client configuration to a file on the computer, perform the following steps: 1. Click the Save Configuration to File button. The Save As dialog box opens. 174 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Navigating The Prosthetist Interface 2. Navigate to the directory where you want to save the file. When you save the configuration to a file, a default file name appears in the File name box. This suggested file name is based on the Client ID and the current date and time. You can use this default file name or change it to one of your choosing. 3. Accept the default file name or enter your own file name. 4. Click Save to save the file. Virtual Reality Environment Clicking on the Virtual Reality Environment button opens the Virtual Reality Environment screen. For information on using the Virtual Reality Environment see Chapter 12, “Virtual Reality Environment and Viewing Input Signals”. View Input Signals Clicking on the View Input Signals button opens the Preview Live Dialog screen. For information on viewing input signals see Chapter 12, “Virtual Reality Environment and Viewing Input Signals”. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 175 Chapter 11: Configuring the Arm Using the Prosthetist Interface Status The configuration status is displayed in the Status box to the right of the Configuration pane. See Figure 111. As you configure the arm the status information changes. The following status information is displayed: • Client ID — The current client’s identification. • MAC — The wireless address of the arm currently connected to the PI. • Current Arm Configuration — The current selected arm configuration. • Joint Control — The type of control being used to control motion. Figure 111. Status Arm Illustration The arm illustration to the right of the configuration pane changes depending on the arm assembly selected in the Client Configuration screen. See Figure 112. Note that a right handed arm is always shown regardless of the handedness of the arm system. The possible illustrations are: • Shoulder Configuration • Humeral Configuration • Radial Configuration Figure 112. Arm Illustration Shoulder Configuration Shown 176 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Using the Prosthetist Interface Tool Tips As you scroll over specific areas within the configuration screens tool tips will pop up. These tips provide helpful information on configuring the arm. See Figure 113 for a tool tip example. Figure 113. Example - Tool Tip Tool Tip Using the Prosthetist Interface The Prosthetist Interface (PI) graphical user interface provides step by step procedures for configuring the arm. Initially, you need to sequentially perform all five steps to configure the arm. After the initial configuration you can access any of the steps in order to change the arm’s configuration. Once you have configured the arm you and the client can then test the arm’s configuration using the Virtual Reality Environment prior to actually moving the arm. Then you can move on to controlling the arm directly. The five configuration steps are described in the following sections. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 177 Chapter 11: Configuring the Arm Using the Prosthetist Interface STEP 1: Discover and Select Master Arm Controller (MAC) The first step in configuring the arm is to discover and select the MAC. The MAC is the main computer in an arm system. It has the wireless radio that communicates to the PI through the PC dongle. Step 1: Discover and Select MAC in the configuration process opens the Discover and Select Master Arm Controller (MAC) screen. This screen allows you to discover all Master Arm Controllers in the area and select the MAC for your client’s arm. The arm must be ON for the MAC to be discovered by the PI. See Figure 114. • Ensure the PC dongle is inserted into a USB port on your computer before opening the Prosthetist Interface • Ensure the arm is ON before discovering and selecting the Master Arm Controller To open the Discover and Select Master Arm Controller (MAC) screen, click the Step 1: Discover and Select MAC button from the PI main screen. See Figure 114 and Table 21 for more information. Figure 114. Step 1: Discover and Select MAC Step 1 178 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 STEP 2: Client Configuration Table 21. Step 1: Discover and Select MAC - Fields and Buttons Field/Button Description MACs Discovered A list of Master Arm Controllers discovered when you click the Refresh Discovered MAC List button. Current MAC box The MAC currently selected. This selection is saved and appears the next time the PI is opened. Clear Current MAC Disconnects the MAC from the system. Refresh Discovered MAC List Discovers all MACs within the area. Discovering and Selecting the MAC To discover and select the MAC for your client’s arm, perform the following steps: 1. Click Refresh Discovered MAC List to discover the MACs within the area. The MACs Discovered box is populated with the discovered MACs. 2. Locate the serial number label on the wrist and read the arm’s MAC address. 3. If a MAC icon already exists in the Current MAC box from a previous connection, click clear current MAC to clear the box. 4. To select and establish a connection with the MAC for your client's arm, either double click on the MAC icon or drag and drop the MAC icon into the Current MAC box. STEP 2: Client Configuration The next step in configuring the arm is to create and save a new client configuration file or load a previously saved client configuration file. You will also need to select the arm assembly to be used by the client. Step 2 also allows you to read a client’s configuration file directly from the arm or clear the current loaded configuration. The Client Configuration screen allows you to configure the following parameters: Initial Configuration When completing an initial configuration set the following parameters: • Create a New Configuration • Select the Arm Assembly • Zero the Shoulder (if fitting an SC arm) Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 179 Chapter 11: Configuring the Arm Using the Prosthetist Interface Existing Configurations When working with existing configurations the following parameters are available: • Clear the Arm Configuration • Read the Current Configuration from the Arm • Load a Configuration from File To open the Client Configuration screen, click the Step 2: Client Configuration button from the PI main screen. See Figure 115 and Table 22 for more information. Figure 115. Step 2 - Client Configuration Step 2 Table 22. Step 2: Client Configuration - Fields and Buttons Field/Button Create New Configuration: Description • Client ID: The personal identification of the client. The client ID can be up to 32 characters long. • Notes: Allows you to attach any related notes to the client’s configuration file. 180 Select Arm Assembly: A drop down list that allows you to select the client’s arm configuration. Zero Shoulder Configures the shoulder’s neutral position. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 STEP 2: Client Configuration Table 22. Step 2: Client Configuration - Fields and Buttons Field/Button Description Clear the Current Configuration: Clears the configuration from the PI environment. NOTE: Clearing the configuration from the PI environment does not clear the configuration from the arm. Read the Configuration from the Arm: Click the Read Configuration button to read the current configuration loaded on the arm. Load a Configuration from File: Click the Load Configuration button to load a previously saved client configuration file. NOTE: Loading a configuration into the PI environment with this command does not load the configuration onto the arm. Create a New Configuration To create a new configuration perform the following steps: 1. In the Client ID field, enter in the client’s identification. The Client ID can contain up to 32 characters. The following characters can’t be used: / \: *? “< > | It is recommended that the Client ID field not contain any personal information (e.g., name, initials). When entering any information into a configuration file, refer to the HIPAA (Health Insurance Portability and Accountability Act) guidelines about confidentiality. See http://www.hhs.gov/ocr/privacy. 2. In the Notes field, enter any information you would like to relate to the client’s configuration file. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 181 Chapter 11: Configuring the Arm Using the Prosthetist Interface Select the Arm Assembly From the Select Arm Assembly drop down list, select the correct arm configuration for the client. The possible values are: • Shoulder Configuration • Humeral Configuration • Radial Configuration When you select an arm assembly, a picture of the arm’s configuration is displayed in the arm illustration box on the PI main screen each time the client file is opened. Zero the Shoulder (if fitting an SC arm) After initially mounting the SC arm to the socket, see Mounting the SC Arm, you must configure the shoulder to the neutral position. To zero the shoulder or configure the arm’s neutral position, perform the following steps: 1. Have the client don the Arm System and stand up straight. 2. Click the Zero Shoulder button. The Configure the Shoulder’s Neutral Position screen opens. See Figure 116. 182 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 STEP 2: Client Configuration Figure 116. Configuring the Shoulder’s Neutral Position 3. Follow the step by step instructions in this screen to zero the shoulder. 4. If completing an initial configuration, you can continue to STEP 3: Configure ACI Modules. Clear the Arm Configuration To clear the arm configuration perform the following steps: 1. Click the Clear Configuration button. The OK to lose changes to current configuration screen opens. See Figure 117. Figure 117. Change to Current Configuration Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 183 Chapter 11: Configuring the Arm Using the Prosthetist Interface 2. Click OK to lose changes to current configuration. Note that at this point, the configuration is cleared from the computer only and is not cleared from the arm. Update Arm must be performed to send the cleared configuration to the arm. Once the configuration is cleared from the arm, the arm will not operate until a new configuration is loaded. 3. Click Update Arm to load a cleared, blank configuration to the arm. The Save Configuration to File screen opens. See Figure 118. Figure 118. Save Config to File 4. Click Yes if you would like to save a copy of the cleared, blank configuration for future reference. 5. Click No to continue to update the arm without saving a copy of the configuration. 6. Power cycle the arm. See Re-Initializing the Arm. Read the Current Configuration from the Arm To read the current arm configuration perform the following steps: 1. Click the Read Configuration button. The current arm configuration is read to the system. 184 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 STEP 3: Configure ACI Modules Load a Configuration from File To load a saved client arm configuration perform the following steps: 1. Click the Load Configuration button. The directory of the saved configuration files opens. See Figure 119. Figure 119. Saved Client Configuration Files 2. Double click the client configuration file you want to load. The Write Configuration to Arm dialog box opens asking if you want to update the arm with the current configuration. See Figure 120. Figure 120. Write Configuration to Arm 3. Click Yes to update the arm with the selected configuration. STEP 3: Configure ACI Modules Step 3 in the configuration process is to configure the ACI Modules. In the Main PI screen click Step 3: Configure ACI Modules to open the Configure Arm Control Interface (ACI) Modules. You can configure up to four ACI Modules per arm. To configure the ACI Modules perform the following steps: 1. In the PI main screen click the Step 3: Configure ACI Modules button. The Configure Arm Controller Interface (ACI) Modules configuration screen opens. See Figure 121 and Table 23 for more information. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 185 Chapter 11: Configuring the Arm Using the Prosthetist Interface Figure 121. Step 3: Configure ACI Modules Step 3 Table 23. Arm Control Interface - Fields and Buttons Fields/Buttons Description Read Current Settings from Arm Reads the current ACI configuration from the arm. Apply Changes to Arm Applies configuration changes to the arm. Comm Mode (Module 1 - 4) The Communications Mode used by the ACI Module. The possible values are: • No Module • Wireless IMU • Wired Input Type (Wireless IMU) The types of wireless inputs used to control the arm. The possible values are: • None • Right IMU • Left IMU 186 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 STEP 3: Configure ACI Modules Table 23. Arm Control Interface - Fields and Buttons Fields/Buttons Input Type (Wired) Description This field is used to identify which inputs on an ACI are EMG sensors. The possible values are: • None • CH 1 • CH 2 • CH 3 • CH 4 Refresh Discovered Device List Updates the list of discovered devices. Discovered Devices Displays list of discovered devices. Wired ACIs 2. If configuring a wired ACI Module, select Wired from the Comm Mode drop down menu. The Module number (1-4) will be the Module ID assigned to the wired ACI device. 3. Identify any EMG Channels from the Input Type drop down list. Configuring wired ACI modules unlocks EMG specific configuration options. Wireless IMUs 4. If configuring a wireless IMU, select Wireless IMU from the Comm Mode drop down menu and right or left IMU from the Input Type drop down menu. 5. Click the Refresh Discovered Device List button to search for wireless IMUs. 6. Drag and drop the selected device from the Discovered Devices list into the appropriate “Set #1” or “Set #2” Wireless Device box. If configuring the system to have two sets of IMUs, be sure to clearly label each set of IMUs for the client. Configuring a New ACI for the First Time To configure a new ACI perform the following steps: Assigning an ACI Module ID is only required if more than one ACI Module is being used. Note that all ACI Modules are shipped with a default ID of 1. In almost every case, the ACI should be assigned to Module 1 in Step 3. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 187 Chapter 11: Configuring the Arm Using the Prosthetist Interface 1. Click the Configure Module ID button. The Configure Wired ACI Module ID configuration screen opens. See Figure 122. Figure 122. Configure Wired ACI Module ID 2. To assign the Module ID to the wired ACI device, first remove the label on the ACI covering the USB port, then connect the wired ACI device to your computer using a USB cable. 3. Click Connect to automatically detect and specify the COM port associated with the connected ACI. 4. Click the Assign ID button. The Configure Wired ACI Module screen will state you have successfully assigned the wired ACI device an ID. This ID will automatically match the Module number you have already assigned the ACI in Step 3. See Figure 123. Figure 123. Successful Assignment of Wired ACI Device 188 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 STEP 3: Configure ACI Modules 5. Click Done. Once you have completed configuring the ACI module ID you need to ensure the USB port on the ACI is covered. Locate the label that covers the port in the materials kit and apply the label over the port. Covering the port is required to maintain the IP52 rating for the arm system. Saving the ACI Configuration To save the ACI configuration perform the following steps: 1. After completing ACI assignments click the Apply Changes to Arm button which will be illuminated in blue. You will be prompted to power cycle the hardware. See Figure 124. Figure 124. Power Cycle the Arm 2. Turn OFF the arm by pressing the ON/OFF button. The power LED, next to the ON/OFF button, is turned OFF when power is off. 3. Turn ON the arm by pressing the ON/OFF button and holding it down until the power LED next to the ON/OFF button lights blue. 4. Click OK. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 189 Chapter 11: Configuring the Arm Using the Prosthetist Interface Understanding Thresholds and Gains Thresholds and gains are two terms used in configuring the arm. These terms are described below. Thresholds A threshold is the signal level which specifies the point at which the signal commanded by the client is translated into motion or switching command by the arm. Upper and Lower Thresholds in the PI are represented by a pair of horizontal bars on the vertical scale in the configuration screen. Gains Gain is the amplification or scaling factor of the input signal. Gain is calculated as the ratio of output over input. When you adjust the gain using the gain dial, you are changing how the arm responds to a user input signal. Setting Joint or Motion Speed Limits When setting joint or motion speed limits you need to note the following: 190 • Mobius Bionics recommends that clients NOT watch the Prosthetist Interface configuration screens while configuring the arm. Allowing the client to watch the screens prompts them to respond to the signal level intensity by visual response. This can interfere with the clients response of inputs to outputs and affect their comfortable exertion levels. • Reassess the configuration based on client comfort throughout the configuration process. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Setting Joint or Motion Speed Limits Input Gains When setting Input Gains note the following: • Mobius Bionics recommends an IMU range of motion of +/- 35 degrees from zero reference. Note that any client inputs above 45 degrees will be ignored. • Set input gains based on comfortable exertion levels. • The input gains should be adjusted so that the client can reach 100% input signal at comfortable exertion levels. Performing the steps above for Input Gains caps the maximum input signal at these exertion levels. Input Thresholds When setting Input Thresholds note the following: • Start with an input threshold setting of 15 to 20 above the resting signal level when the axes are configured independent or coupled. • Only decrease these settings as the client develops proficiency in using the arm. Output Gains The output signal level represents a fraction of the maximum joint speed the client is allowed to use. The output gain is the final control you should use to define the output speed. When setting Output Gains note the following: • Adjust the output gains so that the output signal at the client’s comfortable maximum exertion level produces the desired joint or motion output speed. • Mobius Bionics recommends starting with an output signal level of 30 to 50%. • Only increase these settings as the client develops proficiency in using the arm. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 191 Chapter 11: Configuring the Arm Using the Prosthetist Interface Step 4: Configure Inputs To configure the IMUs you must select the Activation Channel and set the Thresholds and Gains for the left IMU anterior/posterior, left IMU medial/lateral, right IMU anterior/posterior, and right IMU medial/lateral. If you have configured the client’s system to have two sets of IMUs, these settings will apply to both sets. Prior to configuring the inputs you need to verify that the input signals are functioning properly by viewing the View Input Signals screen. See Viewing Input Signals. To configure the IMUs perform the following steps: 1. In the PI main screen click the Step 4: Configure IMUs button. The IMU Setup screen opens. See Figure 125 and Table 24 for more information. Figure 125. Step 4: Configure Inputs Step 4 192 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Step 4: Configure Inputs The full red bar, as shown in Figure 125, is an indication that the IMUs have not been zeroed. After zeroing the IMUs the red bar will be displayed as shown in Figure 126. Table 24. IMU Setup - Fields and Buttons Fields/Buttons Input Type Description The type of input used to control the arm. The selections on the screen are: • IMU • Rate Sensitive • Pattern Recognition NOTE: Selections that are not available are grayed out. Activate/Zero IMUs Activates and zeros the IMUs. Independent Allows output of only the intended command axes with the greater signal intensity on an IMU. Coupled Allows for simultaneous output of both axes of an IMU. Walk Detect Enables (active) or disables (inactive) walk detect. Walk detect ignores commands from the IMU when the client is walking. 2. Select the corresponding motion for the correct IMU as indicated in the IMU Setup screen. The input level should hover or “zero” somewhere around the midpoint of the scale. If it does not, perform the following to “re-zero” the IMUs: a. Have the client stand with the IMUs in the desired zero position (usually feet flat on the floor). b. Press the Activate/Zero IMUs button. See Figure 126. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 193 Chapter 11: Configuring the Arm Using the Prosthetist Interface Figure 126. Activate/Zero IMUs The client should be standing during IMU configuration as there is less freedom of movement when the client is bearing weight on their feet. 3. Communicate and demonstrate to your client that the IMUs, mounted on each foot, function by measuring the pitch (anterior/posterior movements) and roll (medial/lateral movements) of the client’s foot. 4. Configure the Upper and Lower Gains for the Left IMU. Adjust the Upper and Lower Gain dials so that full signal is displayed on the bar graph when the client pitches and rolls the IMU at a comfortable maximum position. 5. Configure the Thresholds for the left IMU. Start with an input threshold setting of 15 to 20 above the resting signal level and the IMU axes configured to coupled. When configuring Thresholds in a coupled configuration the goal is to set thresholds to prevent unintended crosstalk of pitch and roll commands while making the activation range as symmetrical as possible in the coupled movement directions (anterior/posterior and medial/lateral). This is accomplished by: a. Setting the Anterior and Posterior Thresholds such that Medial and Lateral movements do not cause the Anterior/Posterior signal level to cross the thresholds and cause unintended motions. 194 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Step 4: Configure Inputs b. Setting the Medial and Lateral Thresholds such that Anterior and Posterior movements do not cause the Medial/Lateral signal level to cross the threshold and cause unintended motions. c. Setting the Thresholds by entering the threshold value in the threshold box or by dragging the corresponding threshold sliders. 6. Repeat Steps 4 and 5 for the Right IMU. 7. If the client is unable to independently actuate each motion of the IMU with modest thresholds, the independent option for the IMU axes should be selected. This allows for command of one axis at a time. If the independent option is selected repeat steps 1 through 7 above. 8. Click the Update Arm button. If, after configuring the action (STEP 5 in the configuration process), the arm moves due to crosstalk of the pitch and roll commands, check that the IMUs are properly positioned then increase the Threshold until the unintended motion stops. As an alternative, selecting the independent option allows for command of only one axis at a time. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 195 Chapter 11: Configuring the Arm Using the Prosthetist Interface Step 5: Configure Arm Actions Configuring Arm Actions allows you to configure arm and hand control and well as selected grips. To configure the arm actions perform the following steps: 1. In the PI main screen click the Step 5: Configure Arm Actions button. The Arm Action screen opens. The Arm Action screen changes based on the type of arm configuration (RC, HC, SC) selected in Step 2. See Figure 127 and Table 25 for more information. Note that the Arm Action screen will change based upon the type of arm configuration selected in Step 2. Figure 127. Step 5: Configure Arm Actions (SC Arm Shown) Step 5 196 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Step 5: Configure Arm Actions Table 25. Configurable Arm Actions Control Action Arm Control (SC Arm Only) Voluntary Elbow Positioning Configures the medial/lateral positioning of the elbow. This moves the elbow in space medially towards the center of the client’s body or laterally away from the client’s body by rotating the elbow about an axis. This axis is between the shoulder and the current hand position. Hand Forward/Backward Configures moving the hand forward or backward. Hand Up/Down Configures moving the hand up or down. Hand Left/Right Configures moving the hand left or right. Humeral Rotation Configures moving the humeral rotator. Elbow Flexion/Extension Configures moving the elbow. Pronation/Supination Configures the rotation of the wrist. Pronation is the internal rotation resulting in the palm moving posteriorly or down. Supination is the external rotation resulting in the palm moving anteriorly or up. Compound Wrist Configures the wrist flexion, wrist extension, ulnar deviation, and radial deviation of the wrist. Hand Open/Close Configures the opening and closing of the hand. Include in Arm Control Allows you to configure up to three hand actions to be performed in Arm control. Arm Control (HC Arm Only) Hand Control Description Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 197 Chapter 11: Configuring the Arm Using the Prosthetist Interface Table 25. Configurable Arm Actions Control Action Toggle Grip Select Selectable Grip — Activates one or more grips from the Selectable Grips configuration box. Description Toggled Grips = Allows you to select a grip by inserting a check next to the grip. The possible grips are: • 1 = Power Grip • 2 = Tool Grip • 3 = Fine Pinch Grip Closed • 4 = Fine Pinch Grip Open • 5 = Lateral Pinch Grip • 6 = Chuck Grip Mode Select Delay — Sets the delay for the mode select from the Delay configuration box Turn Off Delay = The amount of time, in seconds, the client needs to hold a command in order to put the arm into Standby mode. InterActivation Delay = The amount of time between commands before the next command is recognized. Tactor Activation Trigger 198 Tactile Feedback Provides feedback as to how much pressure is applied through the arm’s fingers. Mode Select Provides a pulsed feedback when changing arm modes. Both Provides both tactile feedback and mode select feedback to the client. Activate/Zero IMUs Activates/Deactivates and Zeros IMUs Clicking this button activates the IMU and resets the IMU to the neutral or zero position. When you activate the IMU, this button changes to Deactivate. Clear Current Action NA Erases the settings for the current selected action. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Step 5: Configure Arm Actions Selecting and Activating an Action To select, configure, and activate an action perform the following steps: 1. Select the action you want to configure. When you click the action the dynamic configuration screen changes for that action. 2. Configure the action using the dynamic configuration screen. 3. Once you have configured the action, activate the action by clicking the Activate check box next to the action and click the Update Arm button. If the Activate check box is already checked, do not click it again. This will deactivate the action. Note that when you un-click the Activate check box the action is not deleted, it is just deactivated. To activate the action, click the Activate check box next to the action. Configuration Screens - Arm Actions When you click the Configure Action button the configuration screen for the selected arm action is displayed. The configuration screen sets the threshold and gain and is similar to the process performed in STEP 4. See Figure 128 and Table 26 for more information. You may need to work through the configuration process with the client a couple of times to let them experiment with different configurations until they settle on one setup that is intuitive and is most easily controlled. When you select an IMU for a particular action, changing the input gains and thresholds requires returning to the IMU configuration. See Step 4: Configure Inputs. If, after configuring the action, the arm moves due to crosstalk of the pitch and roll commands, the thresholds should be increased until the unintended motion stops. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 199 Chapter 11: Configuring the Arm Using the Prosthetist Interface Figure 128. Example Configure Action Screen - Toggle Grip Select If you remove a grip in Toggle Grip Select while that grip is currently selected, that grip will remain selected until you toggle out of the grip. Table 26. Configure Actions Settings Glossary Setting 200 Description Single Site Configures both positive and negative direction motion in a joint with a single channel that provides for both positive and negative signal levels, such as a linear transducer. Dual Site Configures both a positive and negative direction motion in a joint using two separate channels each with unique gains and thresholds. IMU Configures an existing IMU channel for both the positive and negative direction motion in a joint. Input Channel An input signal source, connected to a specific type of sensor the client uses to signal control intent. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Step 5: Configure Arm Actions Table 26. Configure Actions Settings Glossary Setting Description Input Gain For Single Site and Dual Site inputs, this should be adjusted so that the client can reach 100% input signal at a comfortable exertion level. Threshold Value Input signals below this level are ignored by the system. Select Activation Mode (Single Site only) This parameter selects how the system reacts to command signals when the system transitions from Standby to Hand or Arm (if applicable) modes. The Active Zero option allows you to set a “zero” point at a selected level of the input signal. Changes relative to the “zero” of the input signal are treated as command inputs. The Conventional option turns off this feature in single site inputs. Active Zero is built into IMU input functions, and can be selected for Single Site inputs, but not Dual Site inputs. Note that the Active Zero function of the IMUs cannot be shut off. Output Gain Allows you to increase or decrease the amount of output gain in order to achieve an ideal response after you have properly set up the input gains. This effectively sets the velocity response of the joint being configured. Switch Direction Allows you to change the direction of movement that occurs when an input is active. Velocity Control Allows you to configure the controls in velocity mode where the velocity of the joint is controlled based on how hard the client presses on the sensor. This control is similar to using a joystick. Position Control Allows you to configure the controls in position mode where the joint is controlled to a desired position commanded by the client. This control is similar to using a mouse or a touchpad. Go to each appropriate Action and configure settings according to what the client wants (the process is similar to the steps used in Step 4). You may go through this process a couple of times to let the client experiment with different configurations until they settle on one setup that is intuitive to them and is most easily controlled. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 201 Chapter 11: Configuring the Arm Using the Prosthetist Interface Tool Tips and Keyboard Shortcuts As you scroll over specific areas within the configuration screens tool tips will pop up. These tips provide helpful information on configuring the arm. See Figure 113 for a tool tip example. When you scroll over the VRE Image Control keys a tool tip pops up providing you with the keyboard shortcut for that movement. Figure 129. Example - Tool Tip Tool Tip What’s Next The next step is to check and confirm the arm’s configuration using the Virtual Reality Environment (VRE) and View Input Signals. The VRE allows the client to practice moving the arm using the selected control scheme. The View Input Signals allows you to view channel signals. For detailed information on the Virtual Reality Environment and View Input Signals see Chapter 12, “Virtual Reality Environment and Viewing Input Signals”. 202 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Chapter 14: Maintaining and Troubleshooting the Arm Troubleshooting The following tables provide solutions to solving problems with the arm. Table 29. Troubleshooting - Try This First These basic tips may help you quickly solve problems with the arm: TRY THIS FIRST 1. Put the arm into Standby Mode. 2. Check and secure the IMUs on your feet. 3. Take the arm out of Standby Mode. 1. Power the arm off. 2. Shake the IMUs to wake them. Look for the blinking blue LEDs. 3. Make sure all cables are securely connected. 4. Put your feet flat on the ground 5. Power the arm on. See the tables below to help you in troubleshooting problems with the Arm System: • Table 30, Troubleshooting - Wrist Display and System Faults – • Table 31, Troubleshooting - Arm Function – • Use this table for help with moving the arm or changing grips Table 32, Troubleshooting - Power and Battery Charging – • Use this table for help when Wrist Display LEDs are on or flashing Use this table for help with powering the arm on and charging batteries Table 33, Troubleshooting - Arm and PI Computer Communication – Use this table for help with arm to PI computer communication problems If the solutions in these troubleshooting tables do not solve the problem with the arm, contact Technical Support. See Contacting Technical Support. 226 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Troubleshooting the Arm Table 30. Troubleshooting - Wrist Display and System Faults Problem Cause Solution System Fault Icons Blinking IMU not awake 1. Power the arm off 2. Shake the IMUs to wake them Fault Code: 3 3. Power the arm on IMU battery low 1. Power the arm off 2. Shake the IMU to check the IMU battery charge level and charge if necessary 3. Power the arm on Arm trying to talk to wrong set of IMUs (if two sets are configured) 1. Power the arm off 2. Shake both sets of IMUs to wake them 3. Power the arm on 4. If no fault, the arm is talking to the IMUs that are blinking blue Ham radios, walkie talkies, theft detectors, or metal detectors are affecting the arm 1. Power the arm off 2. Move the arm at least 0.5 m (20 inches) away from any ham radios, walkie talkies, theft detectors, or metal detectors 3. Power the arm on System Fault Icons Blinking Fault Code: 36 ACI not talking to arm 1. Power the arm off 2. Check and tighten all system cables, and replace any damaged cables 3. Power the arm on ACI failure 1. Power the arm off 2. Replace the ACI 3. Power the arm on and set the ACI module ID if necessary Tactor failure 1. Power the arm off 2. Replace the Tactor 3. Power the arm on Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 227 Chapter 14: Maintaining and Troubleshooting the Arm Table 30. Troubleshooting - Wrist Display and System Faults Problem Cause Solution System Fault Icons Blinking Fault Codes: 6, 456 Client configuration invalid 1. Load a configuration from a file into PI 2. Update the arm 3. Power the arm off 4. Power the arm on Client configuration invalid and file corrupt 1. Clear the configuration in PI 2. Update the arm 3. Power the arm off 4. Power the arm on 5. Create a new configuration or load a known good configuration using PI and update the arm System Fault Icons Blinking Arm motors warm Fault Codes: 25, 26, 34, 256 1. Power the arm off 2. Move to a cooler location if possible 3. Wait 15 minutes 4. Power the arm on System Fault Icons Blinking Fault Code: 2346 Shoulder mount angles invalid Zero the shoulder. See Zero the Shoulder (if fitting an SC arm). System Fault Icons Blinking Contact Technical Support. See Fault Code Not Listed Contacting Technical Support. 228 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Troubleshooting the Arm Table 30. Troubleshooting - Wrist Display and System Faults Problem Cause Solution Low Battery Icon On Battery is low 1. Replace the external battery in the holster with a fully charged battery. 2. Plug the AC Adapter into the forearm charging port External battery not connected 1. Check that the external battery is properly seated in the holster 2. Check and tighten the cables between the arm and the holster, and replace any damaged cables if necessary IMU not talking to arm Shake the IMUs to wake them IMU battery is low Charge the IMUs Arm trying to talk to wrong set of IMUs (if two sets are configured) While the LEDs are still sweeping, press the wrist display button Ham radios, walkie talkies, theft detectors, or metal detectors are affecting the arm Move the arm at least 0.5 m (20 inches) away from any ham radios, walkie talkies, theft detectors, or metal detectors Grip Select LEDs Sweeping Sweeping Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 229 Chapter 14: Maintaining and Troubleshooting the Arm Table 30. Troubleshooting - Wrist Display and System Faults Problem Cause Solution Arm Mode LED Blinking Walk Detect 1. Stop walking 2. Put your feet flat on the ground 3. Check that the Arm Mode LED has stopped blinking IMU tilted too far 1. Put the arm into Standby Mode 2. Check and secure the IMUs on your feet 3. Put your feet flat on the ground 4. Take the arm out of Standby Mode Thresholds or gains need adjustment 1. Put the arm into Standby Mode 2. Ask the client to be at a resting position 3. Use PI to check that all non-IMU inputs are below the threshold 4. Adjust the input device thresholds or gains as necessary 5. Update the arm 6. Take the arm out of Standby Mode Input device not working 1. Power the arm off 2. Replace the input device 3. Power the arm on 4. Use PI to check the thresholds and gains for the new input device and adjust if necessary 230 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Troubleshooting the Arm Table 31. Troubleshooting - Arm Function Problem Cause Solution Arm moving without command IMU zero position changed 1. Put the arm into Standby Mode 2. Check and secure the IMUs on your feet. 3. Put your feet flat on the ground 4. Take the arm out of Standby Mode Sweat near EMGs 1. Put the arm into Standby Mode 2. Wipe the sweat from the EMG electrode and skin with a dry cloth 3. Take the arm out of Standby Mode Ham radios or walkie talkies are affecting the arm 1. Put the arm into Standby Mode 2. Move the arm at least 0.5 m (20 inches) away from any ham radios or walkie talkies 3. Take the arm out of Standby Mode Arm not moving Arm is in Standby Mode Put the arm into Hand Mode Arm is off 1. Shake the IMUs to wake them 2. Power the arm on Arm is faulted See Table 30, Troubleshooting - Wrist Display and System Faults. Input device not connected 1. Power the arm off 2. Check and tighten all connections at the ACI 3. Power the arm on Cannot change Modes Input device not connected 1. Power the arm off 2. Check and tighten all connections at the ACI 3. Power the arm on Input device not working 1. Power the arm off 2. Replace the input device 3. Power the arm on 4. Use PI to check the thresholds and gains for the new input device and adjust if necessary Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 231 Chapter 14: Maintaining and Troubleshooting the Arm Table 31. Troubleshooting - Arm Function Problem Cause Solution Cannot change grips Hand is not fully open 1. Put the arm into Hand Mode 2. Fully open the hand 3. Change grips Input device not working 1. Power the arm off 2. Replace the input device 3. Power the arm on 4. Use PI to check the thresholds and gains for the new input device and adjust if necessary Table 32. Troubleshooting - Power and Battery Charging Problem Cause Solution Arm does not power on Internal battery too low 1. Plug the AC Adapter into the forearm charging port 2. The charging status icon first blinks yellow for a few minutes. Wait until the charging status icon blinks blue. 3. Power the arm on External battery too low 1. Replace the external battery in the holster with a fully charged one 2. Power the arm on External battery not connected 1. Check that the external battery is properly seated in the holster 2. Check and tighten the cables between the arm and the holster 3. Power the arm on Internal Battery Charging Charging Status Icon Blinking Yellow Internal battery charging paused 1. Move the arm to a cooler location 2. Wait up to 2 hours. You can keep the arm on and the AC adapter connected while waiting. 3. Charging should continue on its own. If it does not, contact Technical Support. See Contacting Technical Support. 232 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Troubleshooting the Arm Table 32. Troubleshooting - Power and Battery Charging Problem Cause Solution Charging Status Icon On Solid Yellow Internal battery charging fault Contact Technical Support. See Contacting Technical Support. AC adapter failure Replace AC adapter Charging Dock Fault Status Blinking Yellow Charging paused 1. Wait up to 2 hours. You can keep the charging dock on and the battery in the charging dock while waiting. 2. Charging should continue on its own. If it does not, contact Technical Support. See Contacting Technical Support. Charging Dock Fault Status On Solid Yellow Charging fault External Battery Charging Contact Technical Support. See Contacting Technical Support. IMU Charging IMU Yellow LED On Solid Charging paused 1. Wait up to 30 minutes. You can keep the charging pad on and the IMU on the charging pad while waiting. 2. Charging should continue on its own. If it does not, contact Technical Support. See Contacting Technical Support. IMU Yellow LED Blinking Self test failure 1. Remove the IMU from the charging pad 2. Wait 5 seconds 3. Place the IMU on the charging pad 4. If the error persists, contact Technical Support. See Contacting Technical Support. IMU LED off IMU not talking to charging pad 1. Clean the top of the charging pad. 2. Clean the bottom of the IMU. 3. Place the IMU, LED side up, on the charging pad’s center circle. If the solutions in these troubleshooting tables do not solve the problem with the arm, contact Technical Support. See Contacting Technical Support. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 233 Chapter 14: Maintaining and Troubleshooting the Arm Table 33. Troubleshooting - Arm and PI Computer Communication Problem PI can’t connect to arm and no LEDs on PC dongle Cause Dongle failure Solution 1. Close the PI application 2. Remove the PC dongle from the USB port 3. Insert the PC dongle into the USB port 4. If no LEDs on PC dongle, replace the PC dongle 5. Open the PI application 6. Discover and select MAC PI can’t connect to arm and • PC dongle green LED on solid • PC dongle yellow LED off Dongle communication failure 1. Close the PI application 2. Remove the PC dongle from the USB port 3. Insert the PC dongle into the USB port 4. Open the PI application 5. Discover and select MAC PI can’t connect to arm and • PC dongle green LED on solid • PC dongle yellow LED flashing Dongle communication failure 1. Close the PI application 2. Remove the PC dongle from the USB port 3. Insert the PC dongle into the USB port 4. Open the PI application 5. Discover and select MAC PI can’t connect to arm and • PC dongle green LED on solid • PC dongle yellow LED on solid Dongle communication failure 1. Close the PI application 2. Remove the PC dongle from the USB port 3. Insert the PC dongle into the USB port 4. Open the PI application 5. Discover and select MAC 234 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 B Technical Specifications This appendix provides technical specifications for the LUKE arm, battery, AC Adapter and charging pad. Topics in this Appendix include: • Arm Specifications • Battery Specifications • AC Adapter Specifications • Charging Pad Specifications • Arm Radio Specifications Arm Specifications Table 34. Parameter Arm System Specifications Explanation Compliance The LUKE arm system complies with IEC 60601-1:2005 Power Type The arm is internally powered when under battery power Designation The arm is designated Class II when plugged into the AC Adapter Parts Type The arm and all body worn accessories are Type BF applied parts Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 241 Appendix B: Technical Specifications Table 35. Operating Environmental Range Parameter Range Operating Temperature • 10 °C to 40 °C (50 °F to 104 °F) with no degradation in performance • -10 °C to 50 °C (14 °F to 122 °F) with reduced arm speed and/or load capacity Humidity 15% to 93% (non-condensing) Pressure 700 hPa to 1060 hPa Arm and body worn Mobius Bionics supplied accessories IP rating IP52 IMU IP Rating IP57 When using the arm continuously in a hot environment (40 °C, 104 °F) and while charging the internal battery, portions of the forearm and upper arm (if applicable) could reach temperatures of 54 °C - 57 °C (130 °F - 135 °F), when evaluated as directed in IEC 60601-1: 2005-12. Table 36. Transport and Storage Environmental Range Parameter Range Storage Temperature (excluding battery) -25 °C to 70 °C (-13 °F to 158 °F) Humidity 15% to 93% (non-condensing) Pressure 700 hPa to 1060 hPa 242 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Arm Specifications Table 37. Service Life Specifications Part Service Life Arm Expected to function for up to three (3) years with an 18 month service interval Internal and External Batteries Expected to provide at least 80% of new capacity for up to a year of typical use IMU Battery Expected runtime is at least 18 hours for up to a year of use AC Adapter and Charging Pad Expected to function for up to three (3) years External Battery Holster and External Battery Charging Dock Expected to function for up to three (3) years ACI and Cables Expected to function for up to three (3) years Table 38. Mass of Arm Configurations Arm Configuration Mass Shoulder Configuration (SC) 4.7 kg Humeral Configuration (HC) 3.4kg Radial Configuration (RC) 1.4 kg Table 39. Dimensions of Arm Configurations Arm Configuration Dimensions Shoulder Configuration (SC) See Figure 138 Humeral Configuration (HC) See Figure 139 Radial Configuration (RC) See Figure 140 Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 243 Appendix B: Technical Specifications Figure 138. Dimensions of Shoulder Configuration (In Centimeters) 9.8 23 23.2323 See Note 23aa See Note 2 26.4 4.3 23.4 26.4 38.6 14.5 19.5 • Note 1: Upper arm length configurations in 1 cm increments from 26.4 cm to 31.4 cm. See Arm Configurations. • Note 2: Forearm length configurations in 1 cm increments from 23.4 cm to 27.4 cm. See Arm Configurations. Figure 139. Dimensions of Humeral Configuration (In Centimeters) 14.5 12.7 17.3 23.4 19.5 See Note 3 244 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Battery Specifications • Note 3: Forearm length configurations in 1 cm increments from 23.4 cm to 27.4 cm. See Arm Configurations. Figure 140. Dimensions of Radial Configuration (In Centimeters) 12.1 31.6 14.5 Battery Specifications Table 40. Battery Charge and Operation Times Arm System Configuration Battery Type One (1) Hour Charge Operation Time1 SC/HC Internal Battery One (1) Hour Two (2) Hours SC/HC External Battery Two (2) Hours Five (5) Hours RC External Battery Four (4) Hours Ten (10) Hours IMU Not Applicable Not Applicable One (1) Day Full Charge2 Operation Time1 NOTES: 1. Actual use time may vary from stated figures based on use patterns, battery age, and arm configuration. Contact Technical Support for additional information. See Contacting Technical Support. 2. See Chapter 9, “Installing, Connecting, and Charging the System Batteries”for charging time. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 245 Appendix B: Technical Specifications Table 41. Power Specifications - Internal Battery Parameter Range/Explanation Battery Type Lithium-Ion Capacity 30 Watt-Hours Charging time (approximate) 80% capacity in less than 2.0 hours Storage Life Three (3) months without recharging Storage Temperature Short Term (24 Hours Maximum): -25 °C to 70 °C (-13 °F to 158 °F) Long Term: -10 °C to 50 °C (14 °F to 122 °F) Table 42. Power Specifications - External Battery Parameter Range/Explanation Battery Type Lithium-Ion Capacity 74 Watt-Hours Charging time (approximate) 80% capacity in less than 2.0 hours Storage Life Three (3) months without recharging Storage Temperature Short Term (24 Hours Maximum): -25 °C to 70 °C (-13 °F to 158 °F) Long Term: -10 °C to 50 °C (14 °F to 122 °F) Table 43. Power Specifications - IMU Battery Parameter Range/Explanation Battery Type Lithium-Polymer Capacity 190 mAh Charging time (approximation) 80% capacity in less than 2.0 hours Storage Life Three (3) months without recharging Storage Temperature Short Term (24 Hours Maximum): -25 °C to 70 °C (-13 °F to 158 °F) Long Term: -10 °C to 50 °C (14 °F to 122 °F) 246 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 AC Adapter Specifications AC Adapter Specifications Table 44. AC Adapter Specifications Parameter Range/Explanation Input Voltage 100 VAC - 240 VAC Input Frequency 50/60 Hz Input Current 1.5 Amps Operating Temperature 0 °C to 70 °C (32 °F to 158 °F) Operating Humidity 10% to 95% RH, non-condensing Storage Temperature -40 °C to 80 °C (-40 °F to 176 °F) Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 247 Appendix B: Technical Specifications Charging Pad Specifications Table 45. Charging Pad Specifications Parameter Range/Explanation Input Voltage 100 VAC - 240 VAC Input Frequency 50/60 Hz Current Rating 1 Amp Maximum Transmit Frequency Range 100 kHz - 205 kHz Transmit Power <5 W Protocol Qi version 1.1, Wireless Power Consortium Effective Range 10 mm or less Wireless Security Qi version 1.1 Quality of Service Provisions Any debris or clutter between the bottom of the IMU and the Charging Pad may prevent IMU charging. Any increase in the distance between the IMU and Charging Pad will increase communication interference. This interference, however, will not cause any incorrect data to be sent and will not cause any harm to the LUKE arm system. Loss or corruption of data between the IMU and Charging Pad for more than 2 seconds can result in the interruption of charging. In these cases, communication problems can usually be resolved by ensuring the top of the Charging Pad is clean and clear of clutter, the IMU is clean and its label is free of wrinkles, and that IMUs are placed label side down and placed as close as possible to the center of the charging pad targets. 248 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Arm Radio Specifications Arm Radio Specifications Table 46. Arm Radio Specifications Parameter Range/Explanation Transmit and Receive Frequency Range 2.4 - 2.5 GHz Effective Radiated Power <10 mW Modulation Direct Sequence Spread Spectrum per IEEE 802.15.4-2006 Protocol Proprietary Frequency Hopping Communication Protocol FCC Compliance 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. Pursuant to FCC 15.21 of the FCC rules, changes not expressly approved by Mobius Bionics might cause harmful interference and void the FCC authorization to operate this product. This product complies with FCC OET Bulletin 65 radiation exposure limits set forth for an uncontrolled environment. Effective Range (Arm/IMU) 3 m or less Effective Range (Arm/Dongle) 1 m or less Wireless Security Proprietary Frequency Hopping Communication Protocol Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 249 Appendix B: Technical Specifications Table 46. Arm Radio Specifications (Continued) Parameter Quality of Service Provisions Range/Explanation Interruption or corruption of communication between the Arm and IMUs can lead to interruptions in arm motion. Interruption of communication for more than 2 seconds may lead to the system reverting to Standby mode. Interruption of communication for more than 8 seconds results in the system declaring a fault. Common consumer electronic devices that transmit in the same frequency band used by the LUKE arm system may prevent the Arm and IMUs from communicating. Microwave ovens, Bluetooth® devices, Wi-Fi® networks and 2.4 GHz cordless phones, when transmitting or receiving, can cause interruption of communication between the Arm and IMUs. During testing, the LUKE arm system experienced occasional communication interruptions in the presence of Bluetooth mice. It is likely that other devices operating in similar frequency ranges can have a similar effect. This interference, however, will not cause any incorrect data to be sent and will not cause any harm to the LUKE arm system. Some metal detectors and anti-theft detection systems at store exits transmit in the same frequency band used by the LUKE arm system. These devices can cause interruption of communication between the Arm and IMUs. Again, this interference will not cause any incorrect data to be sent and will not cause any harm to the LUKE arm system. In each of these cases, communication problems can usually be resolved by turning off or moving away from other RF transmitting devices. 250 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 C Manufacturers and Part Numbers This appendix lists the Manufacturer and Part Numbers for LUKE arm types, accessories, and user inputs within the LUKE arm system. Topics in this appendix include: • Hand and Finger Covers • General Accessories • User Inputs • Optional Accessories • External Cables LUKE Arms Table 47. LUKE Arm Manufacturers and Part Numbers Arm Type Manufacturer Part Number SC (with Internal Battery) Mobius Bionics LU-105A1-BCD SC (without Internal Battery) Mobius Bionics LU-105A2-BCD HC (with Internal Battery) Mobius Bionics LU-103A1-0CD HC (without Internal Battery) Mobius Bionics LU-103A2-0CD RC Mobius Bionics LU-101A2-00D NOTES: • A designates hand type. 1 = Right Hand, 2 = Left Hand • B designates upper arm length • C designates forearm length • D designates hand length Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 251 Appendix C: Manufacturers and Part Numbers Hand and Finger Covers Table 48. Hand and Finger Cover Manufacturers and Part Numbers Description Manufacturer Part Number Hand Cover, Right Mobius Bionics LU-38012-001 Hand Cover, Left Mobius Bionics LU-38012-002 Nylon Tape for Securing Hand Cover Mobius Bionics LU-41091-001 Finger Cover, Thumb, Right Mobius Bionics LU-38013-001 Finger Cover, Thumb, Left Mobius Bionics LU-38013-002 Finger Cover, Index Mobius Bionics LU-38014-001 Finger Cover, Middle Mobius Bionics LU-38015-001 Finger Cover, Ring Mobius Bionics LU-38016-001 Finger Cover, Pinky Mobius Bionics LU-38017-001 Fingernail, Thumb Mobius Bionics LU-36352-001 Fingernail, Index Mobius Bionics LU-36434-001 Fingernail, Middle and Ring Mobius Bionics LU-36407-001 Fingernail, Pinky Mobius Bionics LU-36403-001 Screw, Fingernail, All Except Pinky Mobius Bionics LU-41005-20060 Screw, Fingernail, Pinky Mobius Bionics LU-41005-20050 252 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 General Accessories General Accessories Table 49. General Accessories Manufacturers and Part Numbers Accessory Manufacturer Part Number ACI Mobius Bionics LU-20264-001 ACI USB Port Cover Mobius Bionics LU-38021-001 External Battery Charging Dock Mobius Bionics LU-20272-001 External Battery Holster (without Power Button)1 Mobius Bionics LU-20273-001 External Battery Holster (with Power Button)2 Mobius Bionics LU-20273-002 PC Dongle Mobius Bionics LU-20275-001 RC Battery Adapter3 Mobius Bionics LU-20311-001 External Battery Mobius Bionics LU-70154-001 AC Adapter Mobius Bionics LU-70214-001 NOTES: 1. Used with all arm types that have an internal battery. 2. Used with all arm types that have no internal battery. 3. Only used with RC arms. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 253 Appendix C: Manufacturers and Part Numbers User Inputs The LUKE arm system has been evaluated with the following input signal sources. Table 50. User Inputs Manufacturers and Part Numbers Input Manufacturer Part Number IMU Mobius Bionics LU-20260-001 Pressure Transducer Mobius Bionics LU-20276-001 EMG Otto Bock 13E200 Linear Transducers Otto Bock 9X50 Liberating Technologies LT01/LT02 Pressure Switch Otto Bock 9X37 Rocker Switch Otto Bock 9X25 Optional Accessories Table 51. Optional Accessories Manufacturers and Part Numbers Accessory Manufacturer Part Number IMU Shoe Clips Mobius Bionics LU-40128-001 Tactor Mobius Bionics LU-20274-001 Tactor Mounting Clips Mobius Bionics LU-40130-001 LU-40176-001 Wireless Charging Pad1 Mobius Bionics LU-70388-001 NOTES: 1. Used to charge up to two IMUs. 254 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 External Cables External Cables Table 52. External Cable Manufacturers, Part Numbers, and Maximum Length Cable Manufacturer Part Number Maximum Length ACI & Tactor Extension Cable Mobius Bionics LU-60068-0000 500 mm External Battery Extension Cable Mobius Bionics LU-60072-0000 1000 mm ACI Straight to Flat Ribbon Cable Mobius Bionics LU-60099-001 500 mm 1 Channel ACI Straight to Otto Bock 9E185 Cable Mobius Bionics LU-60100-000 300 mm 2 Channel ACI Straight to Otto Bock 9E185 Cable Mobius Bionics LU-60101-000 300 mm ACI Right Angle to Flat Ribbon Cable Mobius Bionics LU-60103-001 500 mm 1 Channel ACI Right Angle to Otto Bock 9E185 Cable Mobius Bionics LU-60104-000 300 mm 2 Channel ACI Right Angle to Otto Bock 9E185 Cable Mobius Bionics LU-60105-000 300 mm AC Adapter Line Cord, USA Mobius Bionics LU-70261-001 1830 mm RC Arm Power & CAN Harness Mobius Bionics LU-60119-001 200 mm RISK OF DEATH OR SERIOUS HARM The use of accessories, transducers, and cables other than those specified may result in increased emission or decreased immunity of the LUKE arm system. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 255 Appendix C: Manufacturers and Part Numbers Socket Fabrication Components Table 53. Socket Fabrication Components Description Manufacturer Part Number RC Socket Adapter Mobius Bionics LU-20269-001 RC Socket Adapter Cable Hole Plug Mobius Bionics LU-38035-001 RC Socket Adapter Thread Protector Mobius Bionics LU-38033-001 HC Socket Adapter Mobius Bionics LU-20283-001 HC Socket Adapter Thread Protector Mobius Bionics LU-38034-001 SC Socket Adapter Mobius Bionics LU-37158-001 SC Socket Adapter Screws, M3 x 0.5, 6 mm Long, Flat Head Mobius Bionics LU-41003-30061 SC Bend Bracket Mobius Bionics LU-37156-001 SC Arm Mounting Screws, M4 x 0.7, 12 mm Long, Socket Head Mobius Bionics LU-41000-040121 Spanner Wrench Mobius Bionics LU-80203-001 Fitting Arm Mobius Bionics LU-20293-001 Form Shoulder Mobius Bionics LU-20305-001 256 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 D Guidance and Manufacturer’s Declaration This Appendix details information on the electromagnetic environment and recommended spacing between portable and mobile RF communications equipment (transmitters) and the LUKE arm system. Electromagnetic Environment The LUKE arm system is intended for use in the electromagnetic environment specified in Table 54 and Table 55. The user of the LUKE arm system should assure that it is used in such an environment. Electromagnetic Emissions Table 54. Guidance and Manufacturer’s Declaration - Electromagnetic Emissions Emissions Test RF emissions Compliance Group 1 The LUKE arm system 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. Class B The LUKE arm system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. CISPR 11 RF emissions CISPR 11 Electromagnetic Environment - Guidance Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 257 Appendix D: Guidance and Manufacturer’s Declaration Electromagnetic Immunity Table 55. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test Electrostatic discharge (ESD) IEC 60601 Test Level Compliance Level +/- 6 kV contact +/- 6 kV contact +/- 8 kV air +/- 8 kV air Electrical fast transient/burst +/- 2 kV for power +/- 2 kV for power supply lines supply lines IEC 61000-4-4 +/- 1 kV for input/output +/- 1 kV for input/output lines lines Surge +/- 1 kV line(s) to +/- 1 kV line(s) to IEC 61000-4-5 line(s) line(s) +/- 2 kV line(s) to earth +/- 2 kV line(s) to earth <5% UT <5% UT (>95% dip in UT) (>95% dip in UT) for 0,5 cycle for 0,5 cycle 40% UT 40% UT (60% dip in UT) (60% dip in UT) for 5 cycles for 5 cycles 70% UT 70% UT (30% dip in UT) (30% dip in UT) for 25 cycles for 25 cycles <5% UT <5% UT (>95% dip in UT) (>95% dip in UT) for 5 s for 5 s 3 A/m 3 A/m IEC 61000-4-2 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the LUKE arm system requires continued operation during power mains interruptions, it is recommended that the LUKE arm system be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. 258 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Electromagnetic Environment Table 55. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the LUKE arm system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance: Conducted RF 3 Vrms 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz Radiated RF 3 V/m 10 V/m IEC 61000-4-3 80 MHz to 2.5 GHz 26 MHz to 80 MHz (continued on next page) 3 V/m 80 MHz to 460 MHz 10 V/m 460 MHz to 470 MHz 3 V/m 470 MHz to 690 MHz 20 V/m 690 MHz to 800MHz 20 V/m d = 1.2 P d = 0.35 P d = 1.2 P d = 0.35 P d = 1.2 P d = 0.18 P d = 0.35 P 800MHz to 965 MHz (continued on next page) where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 259 Appendix D: Guidance and Manufacturer’s Declaration Table 55. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Radiated RF 3 V/m 3 V/m IEC 61000-4-3 80 MHz to 2.5 GHz 965MHz to 1.39 GHz Electromagnetic Environment Guidance d = 2.3 P (continued) 20 V/m d = 0.35 P 1.39 GHz to 6.0 GHz Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: Magnetic Fields generated by: • Metal Detectors • EAS Systems and Tag Deactivators (No Standard Applied) N/A 0.1 kHz - 3.5 kHz No special precautions required. 300 A/m 10 kHz - 60 kHz 50 A/m 50 kHz - 150 kHz 30 A/m NOTE 1: At 80 MHz, 460 MHz, 470 MHz, 690 MHz, 800 MHz, 965 MHz, and 1.39 GHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LUKE arm system is used exceeds the applicable RF compliance level above, the LUKE arm system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the LUKE arm system. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 260 Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5 Recommended Separation Distances Recommended Separation Distances The LUKE arm system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the LUKE arm system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LUKE arm system as recommended below, according to the maximum output power of the communications equipment. Table 56 and Table 57 defines the recommended separation distances between portable and mobile RF communications equipment and the LUKE arm system. Table 56. Recommended Separation Distances (Part I) Rated Maximum Output Power of Transmitter Separation Distance According to Frequency of Transmitter 150 kHz 80 MHz 26 MHz 80 MHz 80 MHz 460 MHz 460 MHz 470 MHz 470 MHz 690 MHz d = 1.2 P d = 0.35 P d = 1.2 P d = 0.35 P d = 1.2 P 0.01 0.12 0.035 0.12 0.035 0.12 0.1 0.37 0.11 0.37 0.11 0.37 1.2 0.35 1.2 0.35 1.2 10 3.7 1.1 3.7 1.1 3.7 100 12 3.5 12 3.5 12 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz, 460 MHz, 470 MHz, 690 MHz, 800 MHz, 965 MHz, and 1.39 GHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Rev. 1.5 -- Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document 261 Appendix D: Guidance and Manufacturer’s Declaration Table 57. Recommended Separation Distances (Part II) Rated Maximum Output Power of Transmitter Separation Distance According to Frequency of Transmitter 690 MHz 800 MHz 800 MHz 965 MHz 965 MHz 1.390 GHz 1.390 GHz 6.0 GHz d = 0.18 P d = 0.35 P d = 2.3 P d = 0.35 P 0.01 0.018 0.035 0.23 0.035 0.1 0.055 0.11 0.74 0.11 0.18 0.35 2.3 0.35 10 0.55 1.1 7.4 1.1 100 1.8 3.5 23 3.5 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz, 460 MHz, 470 MHz, 690 MHz, 800 MHz, 965 MHz, and 1.39 GHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Essential Performance The following items are the Essential Performance of the LUKE arm system. The LUKE arm system: 262 • is able to safely power on and off. • enters Standby mode at power on. • hand open button operates normally. • gross motor movements are slowed within the slowdown region. • low battery alert operates normally. Use or Disclosure of Data Contained on this Page is Subject to the Copyright Restrictions on the Inside Title Page of this Document -- Rev. 1.5
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