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

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Warnings, Precautions and Limitations
Please read, understand, and follow the precautionary and operating instructions:
Limitations
SmartStep™ is a biofeedback device and does not prevent injury. Therefore if the
patient feels any pain or discomfort while using the device he should stop using the
device immediately and consult a physician.
Andante Medical Devices Ltd is NOT responsible for any damages that occur as
a result of the misuse of this device.
Physician or therapist must check very high arches in their patients. In cases of
a high arch, system accuracy will be reduced.
SmartStep™ should only be used in accordance with the exercise options
provided in the software and should not be used while running, jumping, etc.
Weight limits should be set by qualified personal and not by the patient.
A patient with hearing loss, particularly in the higher frequencies should not use
this device as he may not be able to hear the audio feedback tone.
SmartStep™ is designed for use with sports shoes only. Do not use with other
types of shoes.
Patients must wear socks during sessions. SmartStep™ should not be used by
barefoot patients.
SmartStep™ should not be used in cases of:
oNon-weight bearing prescription.
oActivity limitations due to medical disorder, medication, or emotional
conditions.
oVascular insufficiencies or infection.
oSevere cognitive disabilities.

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Warning and Precautions
Control Unit
Never try to connect any other device and/or cable to the Charging connector
of the Control Unit (e.g. telephone device or cables).
The plastic cover used to seal the Charging connector should never be
removed while the unit is on the patient’s leg. The cover should only be
removed when charging the unit.
When charging the Control Unit, the unit and its strap must be removed from
the patient’s leg.
This equipment has been approved for mobile applications where the
equipment should be used at distances greater than 20cm from the human
body (with the exception of hands, wrists, feet and ankles). Operation at
distances less than 20cm is strictly prohibited.
Protect the Control Unit from any contact with water, such as dampness from
sinks, bathtubs and shower stalls, or wet weather such as rain or snow. Do
not use water or any other liquids to clean the Control Unit.
Shock or impact may damage the Control Unit.
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.
Important Charging Information
Only use the charger provided with your SmartStep™ system. Do not substitute
with any other charger. Use of another charger could cause batteries to explode
and possible serious injury.

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Charging must be done outside the patient environment and should be obtain in
the medical used room.
Do not operate the charger with a damaged cord or plug. If damaged, have
the charger replaced immediately by a qualified service technician. 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.
Do not use the charger if it has received a sharp blow, been dropped, or
otherwise damaged in any way. Consult an Andante service technician to
replace the charger. Following this rule will reduce the risk of electric shock,
fire, or serious personal injury.
When the charger is not in use, disconnect it from the power source. Do not
leave the battery connected to charger for longer than a week, since
overcharging may shorten its lifespan. If left unused, a fully charged battery
will discharge itself over time.
Important Battery Information
There is a risk of explosion if battery is replaced by an incorrect type.
For disposal and replacement of a used battery, consult an authorized Andante
service technician.
The Control Unit is powered by a rechargeable NiMH battery. Note that a new
NiMH battery’s full performance is achieved only after two or three complete
charge and discharge cycles.
The battery can be charged and discharged hundreds of times but it will
eventually wear out. When the operating time is noticeably shorter than
normal, it is time to replace the battery.
Do not try to remove the battery. Contact qualified service personnel to
change the battery when needed.
Computer
The computer should be at least 1.5m away from the patient.

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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 to
manufacturers.
It is advised to change the insole once every three months. If insole use
extends beyond three months, system accuracy may be affected. You will find
a replacement parts order form at the end of this document.
Due to risk of transferable infections, it is highly recommended not to transfer
this insole to other users.
General
The SmartStep™ system is to be used under the supervision of a physician or
licensed health care provider such as a physiotherapist in rehabilitation units or
clinics.
The system is intended for indoor operation only.
Use of SmartStep™ outside the optimal range of operation (15-80 Kg) may lead
to reduced accuracy of about 10%.
Always ensure that shoelaces are tightly tied and do not become tangled up
with the pneumatic tubes or other components.
An improperly fitted shoe could result in distorted readings or injury.
Only use SmartStep™ on solid surfaces. Avoid rugged, uneven terrain or steep
inclines.
Do not operate SmartStep™ on slick or wet surfaces.
Environments with excessive dirt, humidity, dust or debris may damage
SmartStep™.
US Federal Law restricts this device to sale by or on the order of a physician.

Classification
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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.
Sterilization or disinfection – Not required.
Equipment not suitable for use in presence of flammable mixture with air, or with
oxygen, or with nitrous oxide.
Mode of operation – Continuous operation.

Regulatory Compliance
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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. 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.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment
The antenna(s) used for this transmitter must not be co-located or operating in
conjunction with any other antenna or transmitter.
FCC ID: TWMSMARTSTEP0106

Care and Maintenance
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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. High temperatures can
shorten the lifespan of electronic devices, damage batteries, and warp or melt
certain plastics.
Don’t store Control Unit or accessories in cold areas. When the Control Unit
warms up (to its normal temperature), moisture can form inside the Control
Unit, which may damage electronic circuit boards.
Don’t drop, knock, or shake the Control Unit. Rough handling can break internal
circuit boards.
Don’t use harsh chemicals, cleaning solvents, or strong detergents to clean
parts or accessories. Wipe with a soft cloth slightly dampened in a mild soap
and water solution.

Introduction
Objective Assessment
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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.
1.1 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.
1.2 Training
SmartStep™ provide precise feedback in both visual and audio modes. This procedure
enhances the learning process and improves movement control (weight and timing)
and helps to normalize gait patterns.
1.3 Rehabilitation Tracking
The SmartStep™ system records the assessment and training sessions. Historical
data is collected and saved in each session for future examination.
The system allows you to:
1. Easily retrieve past sessions.
2. Analyze past sessions.
3. Compare patient sessions in order to track rehabilitation.
1.4 Using SmartStep™ in Online and Offline Mode
In assessment as well as training, the SmartStep System can be used in online or
offline mode.
In online mode, SmartStep™ communicates with your computer to provide
real-time visual feedback. Audio feedback is also possible. During an online
session, it is recommended to work in the vicinity of the computer (in a 7m
radius).
In offline mode, SmartStep™ provide real-time audio feedback. It is possible
to records session data, and downloaded it to the computer for later analysis.

System Description
SmartStep™ Kit Contents
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2 System Description
2.1 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
or 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).
3. Manual pump.
4. Battery charger for the Control Unit
5. SmartStep software CD.
6. Bluetooth USB adapter.
7. Bluetooth USB adaptor driver installation CD.
8. Quick User’s guide.
If any of the above items are missing, or appear damaged, please contact your
supplier.

System Description
SmartStep™ Components
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2.2 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.
The insole contains two inflatable compartments – the forefoot and the hind foot.
Each compartment is connected, via a tube, to a pressure sensor. When a patient
exerts force on the leg, increased air is driven out of the air pockets and is detected
by the pressure sensors and converted into uneven weight in Kg/lb.
SmartStep™ sessions are performed on a single foot at a time. The insole is suitable
for both left and right feet. It is supplied in a range of sizes (see details in 2.1 above).