Andante Medical Devices SmartStep Clinic User manual

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

Legal Notice
2| SmartStep™ Version 2.1.1 Revision A2
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
secrets and other intellectual property or other proprietary rights relating to this
manual and to the SmartStep™ System (“the Product”), and any software
components contained therein, are proprietary products of Andante protected under
international copyright and patent law and shall be and remain solely with Andante.
SmartStep™ is a trademark of Andante. No right, license, or interest to such
trademark is granted hereunder.
You shall not copy, reverse compile or reverse assemble all or any portion of the
Manual or the Product. You are prohibited from, and shall not, directly or indirectly,
develop, market, distribute, license, or sell any product that supports substantially
similar functionality as the Product, based on or derived in any way from the Product.
All brand and product names mentioned in this manual are trademarks and/or
registered trademarks of their respective holders.

About this Document
SmartStep™ Version 2.1.1 Revision A2 | 3
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
1 Introduction SmartStep™ functions and usage. Pg. 18
2 System Description SmartStep™ kit contents and system components. Pg. 19
3 Installation How to install the SmartStep™ software. Pg. 24
4 Preparing a Session How to prepare patient, hardware components and
SmartStep™ software for a session. Pg. 48
5 Starting a Session How to begin a session, connect to the Bluetooth USB
adapter, and perform calibration. Pg. 53
6 Online Work How to define an online session. Pg. 62
7 Offline Work How to define an offline session and download data to the
computer. Pg. 68
8 Tracking the
Rehabilitation Progress How to open saved sessions, understand and compare session statistics, and manipulate session charts. Pg. 73
9 Turning the Control Unit
Off How to turn the Control Unit off. Pg. 89
10 Maintenance and
Administration How to create users, change passwords, recharge batteries, change insoles, and keep SmartStep™ clean. Pg. 90
11 Troubleshooting How to deal with various operating problems. Pg. 93
Style Conventions
Convention Used for
Verdana Regular text.
Arial Bold Names of menus, commands, buttons, and other elements of the user interface.
Arial Italics Special terms, the first time they appear.
Monospace Text entered by a user, values of parameters, and usage examples.
Notes, which offer an additional explanation or a hint on how to overcome a common
problem.

About this Document
4| SmartStep™ Version 2.1.1 Revision A2
Warnings, which indicate potentially damaging user operations and explain how to
avoid them.

Table of Contents
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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
LIMITATIONS .......................................................................................... 11
WARNING AND PRECAUTIONS ....................................................................... 12
CLASSIFICATION.....................................................................................15
REGULATORY COMPLIANCE .....................................................................16
CARE AND MAINTENANCE........................................................................17
1INTRODUCTION.................................................................................18
1.1 OBJECTIVE ASSESSMENT ..................................................................... 18
1.2 TRAINING ...................................................................................... 18
1.3 REHABILITATION TRACKING.................................................................. 18
1.4 USING SMARTSTEP™IN ONLINE AND OFFLINE MODE.................................... 18
2SYSTEM DESCRIPTION.......................................................................19
2.1 SMARTSTEP™KIT CONTENTS ............................................................... 19
2.2 SMARTSTEP™COMPONENTS ................................................................ 20
2.2.1 Insole................................................................................ 20
2.2.2 Control Unit........................................................................ 21
2.2.3 SmartStep™ Software.......................................................... 23
2.2.4 Manual Pump...................................................................... 23
3INSTALLATION ..................................................................................24
3.1 SYSTEM REQUIREMENTS...................................................................... 24
3.2 SMARTSTEP SOFTWARE INSTALLATION..................................................... 24
3.3 BLUETOOTH USB ADAPTER DRIVER INSTALLATION....................................... 28
3.4 CONFIGURE SMARTSTEP™FOR BLUETOOTH USAGE ...................................... 46
4PREPARING A SESSION ........................ERROR! BOOKMARK NOT DEFINED.
4.1 CHECK AIR PRESSURE -INFLATE THE INSOLE IF NECESSARY.ERROR!BOOKMARK NOT

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DEFINED.
4.2 REMOVE THE PATIENT’S SHOE .......................ERROR!BOOKMARK NOT DEFINED.
4.3 INSERT THE INFLATED INSOLE INTO THE SHOE.....ERROR!BOOKMARK NOT DEFINED.
4.4 PUT THE PATIENT’S SHOE BACK ON..................ERROR!BOOKMARK NOT DEFINED.
4.5 ATTACH THE CONTROL UNIT TO THE ANKLE........ERROR!BOOKMARK NOT DEFINED.
4.6 CONNECT THE INSOLE TO THE CONTROL UNIT.....ERROR!BOOKMARK NOT DEFINED.
4.7 INSERTING THE BLUETOOTH USB ADAPTER .......ERROR!BOOKMARK NOT DEFINED.
4.8 TURN ON THE CONTROL UNIT .......................ERROR!BOOKMARK NOT DEFINED.
4.9 LAUNCHING THE SMARTSTEP™SOFTWARE........ERROR!BOOKMARK NOT DEFINED.
5STARTING A SESSION........................... ERROR! BOOKMARK NOT DEFINED.
5.1 PATIENT FILE ..........................................ERROR!BOOKMARK NOT DEFINED.
5.1.1 Creating a New Patient File.......... Error! Bookmark not defined.
5.1.2 Opening an Existing Patient File ... Error! Bookmark not defined.
5.2 STARTING A SESSION ................................ERROR!BOOKMARK NOT DEFINED.
5.3 CONNECTING TO THE BLUETOOTH USB ADAPTER.ERROR!BOOKMARK NOT DEFINED.
5.4 PERFORMING CALIBRATION ..........................ERROR!BOOKMARK NOT DEFINED.
6ONLINE WORK...................................... ERROR! BOOKMARK NOT DEFINED.
6.1 DEFINING WORKOUT PLAN AND OPERATION MODEERROR!BOOKMARK NOT DEFINED.
6.2 PERFORMING THE WORKOUT.........................ERROR!BOOKMARK NOT DEFINED.
7OFFLINE WORK..................................... ERROR! BOOKMARK NOT DEFINED.
7.1 DEFINING WORKOUT PLAN AND OPERATION MODEERROR!BOOKMARK NOT DEFINED.
7.2 PERFORMING THE WORKOUT.........................ERROR!BOOKMARK NOT DEFINED.
7.3 DOWNLOADING DATA TO THE COMPUTER ..........ERROR!BOOKMARK NOT DEFINED.
8TRACKING THE REHABILITATION PROGRESS...... ERROR! BOOKMARK NOT
DEFINED.
8.1 OPENING PREVIOUSLY RECORDED SESSIONS......ERROR!BOOKMARK NOT DEFINED.
8.2 UNDERSTANDING SESSION RESULTS ...............ERROR!BOOKMARK NOT DEFINED.
8.2.1 Switching Between Absolute and Relative WeightError! Bookmark
not defined.
8.2.2 Charts ...................................... Error! Bookmark not defined.
8.2.3 Statistics................................... Error! Bookmark not defined.
8.2.4 Viewing Stance/Swing Composition for Specific Steps..........Error!
Bookmark not defined.
8.2.5 Comments ................................ Error! Bookmark not defined.
8.3 MANIPULATING SESSION CHARTS...................ERROR!BOOKMARK NOT DEFINED.

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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.
8.4 COMPARISON STATISTICS............................ERROR!BOOKMARK NOT DEFINED.
8.5 SESSION DELETION...................................ERROR!BOOKMARK NOT DEFINED.
9TURNING THE CONTROL UNIT OFF........ERROR! BOOKMARK NOT DEFINED.
10 MAINTENANCE AND ADMINISTRATION.ERROR! BOOKMARK NOT DEFINED.
10.1 CREATING USERS AND CHANGING PASSWORDS...ERROR!BOOKMARK NOT DEFINED.
10.2 RECHARGING BATTERIES.............................ERROR!BOOKMARK NOT DEFINED.
11 TROUBLESHOOTING..............................ERROR! BOOKMARK NOT DEFINED.
PARTS AND ACCESSORIES ..........................ERROR! BOOKMARK NOT DEFINED.

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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.

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Technical Specifications
Control Unit General Dimensions 110 x 68 x 48 mm
Weight 215 g
Operating Time Approx. 5 Hours (Full battery, max load)
Charging Time Approx. 10 Hours (Empty battery)
Battery Operating Voltage 3.6 VDC
Type Ni-MH Rechargeable battery
Capacity 700 mAh
Power Consumption 0.5 W
Indicators
Mode of Operation 7 Segment
Charging Green LED
Low Battery Orange LED
Memory
Capacity 128 KB
Type Rewritable
Max record time Approx. 10 Minutes
No. of Logged files 1
Connectors
Input Type RJ-11
Input Uses Charging
Communication
Type Wireless
Protocol Bluetooth ver. 1.1 certified
Transmission frequency 2.4 GHz
Output Power 0 dBm (Class 2)
Maximum distance 10 m / 30 ft
Environmental
Conditions Operating Temperature 10 ºC to 40 ºC
Storage Temperature -5 ºC to 50 ºC
Operating Humidity 30% - 75%

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Charger General Manufacturer GlobTek Inc.
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 5 W
Standard UL 60950, CUL, CLASS II
FCC Part 15 CLASS B
Sensors General Type Silicon Pressure Sensor
Compensation Temperature Compensated Over –40° to
+125°C
Operating
Characteristics Pressure Range 0 – 250 kPa
Supply Voltage 5 VDC
Supply Current 7 mA
Sensitivity 18 mV/kPa