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Andante Medical Devices SmartStep Clinic User Manual

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SmartStep™ Clinic
User's Manual
Andante Medical Devices Ltd
© Andante Medical Devices Ltd
http://www.andante.co.il

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Summary of Contents for Andante Medical Devices SmartStep Clinic

  • Page 1 SmartStep™ Clinic User’s Manual Andante Medical Devices Ltd © Andante Medical Devices Ltd http://www.andante.co.il...

  • Page 2: Legal Notice

    Legal Notice Legal Notice This manual contains information that is proprietary to Andante Medical Devices Ltd. (“Andante”). No part of this publication may be reproduced in any form without prior written approval by Andante. Right, title and interest, all information, copyrights, patents, know-how, trade...

  • Page 3: About This Document

    About this Document About this Document This document describes the SmartStep™ insole, Control Unit, and software, used for the assessment and training of walking pathologies. The document is intended for therapists treating patients with walking pathologies. Chapters and Contents Introduction SmartStep™...
  • Page 4 About this Document Warnings, which indicate potentially damaging user operations and explain how to avoid them. 4 | SmartStep™ Version 2.1.1 Revision A2...

  • Page 5: Table Of Contents

    Table of Contents Table of Contents LEGAL NOTICE ................... 2 ABOUT THIS DOCUMENT ................3 TABLE OF CONTENTS ................. 5 INTENDED USE ..................8 TECHNICAL SPECIFICATION ……………………………………………………………... 9 WARNINGS, PRECAUTIONS AND LIMITATIONS........11 ..................11 IMITATIONS ............... 12 ARNING AND RECAUTIONS CLASSIFICATION..................
  • Page 6 Table of Contents DEFINED ’ ....... E EMOVE THE PATIENT S SHOE RROR OOKMARK NOT DEFINED ..E NSERT THE INFLATED INSOLE INTO THE SHOE RROR OOKMARK NOT DEFINED ’ ....E UT THE PATIENT S SHOE BACK ON RROR OOKMARK NOT DEFINED ..
  • Page 7 Table of Contents 8.3.1 Zooming In and Out ....Error! Bookmark not defined. 8.3.2 Measuring Time ......Error! Bookmark not defined. 8.3.3 Measuring Weight...... Error! Bookmark not defined. 8.3.4 Erasing Session Segments ... Error! Bookmark not defined......E OMPARISON TATISTICS RROR OOKMARK NOT DEFINED ........E...

  • Page 8: Intended Use

    Table of Contents Intended Use SmartStep™ is intended to measure the weight applied to the plantar surface of the affected limb during rehabilitation. The device alerts the patient and/or therapist with a beeping sound when the weight exceeds a pre-determined maximum level. SmartStep™ produces objective examination, training and monitoring of gait outcomes, using accurate analysis as well as audio and visual feedback.

  • Page 9: Technical Specification

    Table of Contents Technical Specifications Dimensions 110 x 68 x 48 mm Control Unit General Weight 215 g Operating Time Approx. 5 Hours (Full battery, max load) Charging Time Approx. 10 Hours (Empty battery) Operating Voltage 3.6 VDC Battery Type Ni-MH Rechargeable battery Capacity 700 mAh...
  • Page 10 Table of Contents Manufacturer GlobTek Inc. Charger General Model GT-A81051-0509UW2 Dimensions 54.0 x 40.0 x 29.5 mm Weight 90 g Input Voltage 90 Vac to 264 Vac Output Voltage 9 VDC Max. Output Power Standard UL 60950, CUL, CLASS II FCC Part 15 CLASS B Type Silicon Pressure Sensor...

  • Page 11: Warnings, Precautions And Limitations

    Andante Medical Devices Ltd is NOT responsible for any damages that occur as a result of the misuse of this device.

  • Page 12: Warning And Precautions

    The Control Unit should be operated, transported, and stored within a temperature range of 10-40°C, (50-86°F) and a relative humidity of 30-75%. Do not open the Control Unit case. Only an Andante Medical Devices technician is authorized to disassemble the device.
  • Page 13 Following this rule will reduce the risk of electric shock, fire, or serious personal injury. Do not disassemble the charger. Only an Andante Medical Devices technician is authorized to take the device a part.
  • Page 14 Table of Contents The therapist must not touch the computer and the patient simultaneously Insole The insole must fit the shoe size. Shoes that are too tight may result in inaccurate readings. Please note that shoe sizes vary according manufacturers. It is advised to change the insole once every three months.

  • Page 15: Classification

    Classification Classification Type of protection against electric shock – When the unit is at normal operation: Internally powered equipment. When the unit is at charging: Class ll. Degree of protection against electric shock – Type BF applied part. Classification according to the degree of protection against ingress of water – Ordinary.

  • Page 16: Regulatory Compliance

    Regulatory Compliance Regulatory Compliance The SmartStep system was tested and found to be in compliance with the following standards: Safety IEC 60601-1 IEC 60601-1-1 EMC (Electromagnetic Compatibility) IEC 60601-1-2 ETSI EN 301 489-1 V1.5.1 (2004-09) EN 55011 : 2003 FCC Part 15.247 FCC Statements: This device complies with part 15 of the FCC Rules.

  • Page 17: Care And Maintenance

    Care and Maintenance Care and Maintenance Keep Control Unit and accessories out of reach of small children. Keep Control Unit and accessories dry. Precipitation, humidity, and liquids contain minerals that will corrode electronic circuits. Do not use or store Control Unit or accessories in dusty or dirty areas. Do not store Control Unit or accessories in hot areas.

  • Page 18: Introduction

    Introduction Objective Assessment 1 Introduction SmartStep™ was developed to assist clinicians to accurately assess, treat, and track the rehabilitation of patients who are undergoing gait training, following orthopedic or neurological impairment. Objective Assessment SmartStep™ improves the objective assessment of different aspects of gait outcomes, by accurately measuring the ground reaction force exerted by the patient during different kinds of exercises.

  • Page 19: System Description

    System Description SmartStep™ Kit Contents 2 System Description SmartStep™ Kit Contents The SmartStep™ Kit The SmartStep™ kit contains the following items: 1. 3 insoles in: European sizes 37/8, 41/2 and 43/4 US sizes 6/7, 8.5/10 and 10.5/11.5. 2. Control Unit with strap (which includes a plastic cover for the Charging connector).

  • Page 20: Smartstep™ Components

    System Description SmartStep™ Components SmartStep™ Components SmartStep™ consists of four main components: An insole, Control Unit, software and a manual pump. The following sections explain each of these components in more detail. 2.2.1 Insole Insole The SmartStep™ insole is placed inside the patient’s shoe, and is used to measure the force exerted by the patient on the foot, during an assessment or a training session.

  • Page 21: Control Unit

    System Description Control Unit 2.2.2 Control Unit The Control Unit The SmartStep™ Control Unit serves three purposes: Data relay to a computer via wireless (Bluetooth) communication. The computer must have the SmartStep™ software installed (see 3.2). Connecting the Control Unit to a computer allows you to view a graph of the gait pattern, as the patient performs an online workout.
  • Page 22 System Description Control Unit Control Unit Modes of Operation Operation Name Description mode Control Unit is on. Online assessment mode (when no weight thresholds are determined) Online with graphic visual feedback of patient performance. Assessment Offline assessment mode (when no weight thresholds are determined). Offline Data is collected.

  • Page 23: Smartstep™ Software

    System Description SmartStep™ Software 2.2.3 SmartStep™ Software The desktop software is used to perform the following functions: Monitor gait parameters. Display visual feedback. Show results and statistics from Online/Offline sessions. Track rehabilitation progress. 2.2.4 Manual Pump The Manual Pump The manual pump is designed to inflate the two compartments with air. The manual pump is not connected directly to the insole.

  • Page 24: Installation

    Installation System Requirements 3 Installation System Requirements ® Microsoft Windows XP Professional or Home Edition. 128 MB of RAM minimum, 256 MB or greater recommended. Up to 20 MB of available hard-disk space. SmartStep Software Installation 1. Insert the SmartStep Installation disk into the CD-ROM drive. 2.
  • Page 25 Installation SmartStep Software Installation 3. Click Next. 4. It is recommended to use the default destination folder. Click Next. SmartStep™ Version 2.1.1 Revision A2 | 25...
  • Page 26 Installation SmartStep Software Installation 5. It is recommended to check the Create a desktop icon check-box. Click Next. 6. Click Install. 26 | SmartStep™ Version 2.1.1 Revision A2...
  • Page 27 Installation SmartStep Software Installation 7. Click Finish. SmartStep installation is now complete. The next step is the Bluetooth USB Adapter installation. SmartStep™ Version 2.1.1 Revision A2 | 27...

  • Page 28: Bluetooth Usb Adapter Driver Installation

    Installation Bluetooth USB Adapter Driver Installation Bluetooth USB Adapter Driver Installation To avoid software installation problems, please do NOT insert the Bluetooth USB Adapter until the installation displays a message to do so (step8). 1. Insert the USB Adapter installation disk into the CD-ROM drive. The Setup program should launch automatically.
  • Page 29 Installation Bluetooth USB Adapter Driver Installation 3. Choose the I accept… option, and click the Next button. 4. In this screen it is possible to change the destination folder by clicking the Change… button. It is recommended to use the default destination folder. Click Next.
  • Page 30 Installation Bluetooth USB Adapter Driver Installation 5. Click Install. The installation might take several minutes. 6. If the dialog below opens, click Cancel. 30 | SmartStep™ Version 2.1.1 Revision A2...
  • Page 31 Installation Bluetooth USB Adapter Driver Installation 7. If the dialog below opens, click on the Continue Anyway button. 8. A message box indicating that No Bluetooth device was detected should popup. Please insert the Bluetooth USB adapter and click OK. SmartStep™...
  • Page 32 Installation Bluetooth USB Adapter Driver Installation 9. Click Finish. 10. Click Exit. 32 | SmartStep™ Version 2.1.1 Revision A2...
  • Page 33 Installation Bluetooth USB Adapter Driver Installation 11. Double click on the My Bluetooth Places icon on the desktop. It is also possible to double click the Bluetooth icon that is located in the notification area of the taskbar, or to right click it and select Start Using Bluetooth. 12.
  • Page 34 Installation Bluetooth USB Adapter Driver Installation 13. Click Next. 14. Click Next. 34 | SmartStep™ Version 2.1.1 Revision A2...
  • Page 35 Installation Bluetooth USB Adapter Driver Installation 15. Leave the default settings. Click Next. 16. Click Skip. SmartStep™ Version 2.1.1 Revision A2 | 35...
  • Page 36 Installation Bluetooth USB Adapter Driver Installation 17. Click Finish. 18. Double click the My Bluetooth Places icon on the desktop. 36 | SmartStep™ Version 2.1.1 Revision A2...
  • Page 37 Installation Bluetooth USB Adapter Driver Installation 19. Turn the Control Unit on. In the Bluetooth Tasks menu, click the View Devices in Range option. 20. The list should contain only devices that were already connected to the computer. In the Bluetooth Tasks menu click the Search for Devices in Range option. SmartStep™...
  • Page 38 Installation Bluetooth USB Adapter Driver Installation 21. Right-click the icon marked with the circle (the icon with the question mark on) . Choose the Properties option. 22. Make sure that the device address matches the address on the back of the Control Unit.
  • Page 39 Installation Bluetooth USB Adapter Driver Installation 23. Right click the icon marked with the circle (the icon with the question mark on). Choose the Pair Device option. 24. Enter the four letter Bluetooth Pin Code (marked in the screenshot in step 22). Use capital letters only.
  • Page 40 Installation Bluetooth USB Adapter Driver Installation 25. Double click the icon marked with a circle (the icon with the question mark on). 26. Right click the icon below and choose the Create Shortcut option. 40 | SmartStep™ Version 2.1.1 Revision A2...
  • Page 41 Installation Bluetooth USB Adapter Driver Installation 27. Click the OK button. 28. Choose the My Bluetooth Places option, in the Other Places menu. 29. Right-click the marked icon, and Rename it for later easy recognition. SmartStep™ Version 2.1.1 Revision A2 | 41...
  • Page 42 Installation Bluetooth USB Adapter Driver Installation 30. Right-click the marked icon again, and choose the Properties option. 31. Uncheck the Secure Connection checkbox. Click OK. 32. In the Taskbar notification area right-click the marked icon. Choose the Advanced Configuration option. 42 | SmartStep™...
  • Page 43 Installation Bluetooth USB Adapter Driver Installation 33. Select the Client Applications tab. Select the Bluetooth Serial Port list item and click the Properties… button. 34. Uncheck the Secure Connection checkbox. Click OK. SmartStep™ Version 2.1.1 Revision A2 | 43...
  • Page 44 Installation Bluetooth USB Adapter Driver Installation 35. Choose the Local Services tab. Select the Bluetooth Serial Port list item and click the Properties… button. 36. Uncheck the Secure Connection and the Startup Automatically checkboxes. Click OK. 44 | SmartStep™ Version 2.1.1 Revision A2...
  • Page 45 Installation Bluetooth USB Adapter Driver Installation 37. Double-click the My Bluetooth Places icon on the desktop. 38. Double-click the icon you named in step 29. 39. The location of the serial port number that is required by the SmartStep program is marked in the screenshot.

  • Page 46: Configure Smartstep™ For Bluetooth Usage

    Installation SmartStep™ Antenna Installation Instructions The Bluetooth icon that is located in the notification area of the taskbar can be one of the following colors: White - The adapter is Red - The adapter is not connected to Green - Bluetooth communication connected and enabled.
  • Page 47 Installation Configure SmartStep™ for Bluetooth Usage 2. The Login dialog box opens. 3. Select your User Name from the drop-down menu and type your Password in the edit box. 4. Click the OK button to log in. 5. In the Select Patient window, go to the System menu and select System Configuration. 6.

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