Argo Medical Technologies 30-30-0002 ReWalk P INF User Manual

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User Guide
Argo
™
Designed for Personal Use
Overcoming Mobility Impairment
User Guide
Important
The user of this product has sole responsibility for any malfunction that results from improper use, faulty
maintenance, improper repair, unauthorized service, damage, or alteration by anyone other than Argo
Medical Technologies.
The safety, reliability, and performance of this product can only be assured under the following
conditions:
The product has been used according to the accompanying operating instructions.
All updates, extensions, readjustments, changes, or repairs have been carried out by Argo Medical
Technologies' authorized representatives.
Document Information
User Guide Revision 1, February 2014. Document Number: 60-70-0015.
© Copyright 2012-2014 Argo Medical Technologies, Inc. All rights reserved.
This User Guide is subject to periodic review, update and revision.
No part of this document may be reproduced or transmitted in any form or by any means,
electronic or mechanical, for any purpose, without the express written permission of Argo
Medical Technologies Ltd. Under the law, reproducing includes translating into another language
or format. Every effort has been made to ensure that the information in this manual is accurate.
Argo Medical Technologies Ltd. is not responsible for printing or clerical errors. Information in this
document is subject to change without notice. Argo Medical Technologies, Inc. reserves the right
to change or improve its products and accompanying technical literature without specific notice
of changes or improvements.
Trademarks and Software Information
ReWalk ™ is a registered trademark of Argo Medical Technologies Ltd. All other trademarks are the
property of their respective owners.
Software Protection
As between the parties, Argo Medical Technologies Ltd. retains title to, and ownership of, all
proprietary rights with respect to the software contained within its products. The software is
protected by United States copyright laws and international treaty provision. Therefore, you must
treat the software like any other copyrighted material (e.g. a book or sound recording).
Patent pending
Notification Regarding Training
Warning: Training is mandatory. Use this document as a guide during training and as a
reference after training.
This manual is not a substitute for training.
Page 2 of 66
User Guide
Caution: Before using the ReWalk, read this Guide carefully to attain a solid understanding
of its functions and operations.
Keep this Guide handy so that it can be referred to whenever needed. Follow the operating
procedures and usage described in this Guide.
Do not modify the device, replace parts (with the exception of the batteries), use nonspecified parts, or remove protection devices, as these actions could result in a hazardous
situation.
PLEASE READ THIS USER GUIDE BEFORE
OPERATING THE SYSTEM
Page 3 of 66
User Guide
Israel ◦ Argo Medical Technologies, Ltd.
Kochav Yokneam Building, 6th Floor
P.O. Box 161
Yokneam Ilit 20692
Phone: +972-4-959-0123
Fax: +972-4-959-0125
email: info@rewalk.com
web: www.rewalk.com
United States Office ◦ Argo Medical Technologies, Inc.
33 Locke Drive, 2nd Floor
Marlborough, MA 01752
Phone: +01-508 251-1154
Germany Office ◦ Argo Medical Technologies, GmbH
Potsdamer Platz 11
107585 Berlin
Phone: +49(0)30/25895080
Fax: +49(0)/3025894110
EU Authorized Representative
Gerrit van der Veenstraat 84 HS
1077 EL Amsterdam
Netherlands
Phone: +31(0)20811-0550
Your
Dealer’s
Contact
Information
Disclaimer
Information provided by Argo Medical Technologies is believed to be accurate and reliable. However,
Argo Medical Technologies assumes no responsibility for the use of such information, nor for any
infringements of patents or other rights of third parties, that may result from its use.
Page 4 of 66
User Guide
TABLE OF CONTENTS
1. Introduction
1.1. ABOUT THIS USER GUIDE ..................................................................................................................... 6
1.2. GLOSSARY AND ABBREVIATIONS ............................................................................................................ 6
2. System Description
2.1. INTENDED USE ................................................................................................................................... 7
2.2. INDICATIONS...................................................................................................................................... 7
2.3. CONTRAINDICATIONS........................................................................................................................... 7
3. Safety
3.1. TYPES OF WARNINGS, CAUTIONS AND NOTES .......................................................................................... 8
3.2. GENERAL SAFETY INSTRUCTIONS ............................................................................................................ 9
3.3. SAFETY STANDARDS .......................................................................................................................... 11
3.4. SYMBOLS USED IN THIS GUIDE ............................................................................................................ 11
4. System Components
12
4.1. THE COMMUNICATOR ....................................................................................................................... 13
4.2. THE EXOSKELETON ............................................................................................................................ 16
4.3. THE BACKPACK................................................................................................................................. 16
5. Moving Into the ReWalk
20
5.1. PREPARATION .................................................................................................................................. 20
5.2. SECURING THE REWALK™- P .............................................................................................................. 22
5.3. ACTIVATING THE REWALK_P .............................................................................................................. 24
5.4. REMOVING THE REWALK ................................................................................................................... 25
6. Using the Argo ReWalk
26
6.1. TWO RULES OF THE COMMUNICATOR................................................................................................... 26
6.2. STANDING UP .................................................................................................................................. 27
6.3. SITTING DOWN ................................................................................................................................ 29
6.4. WALKING ........................................................................................................................................ 30
7. Manual and Bypass Mode
32
7.1. MANUAL MODE ............................................................................................................................... 32
7.2. BYPASS MODE ................................................................................................................................. 33
8. The ReWalk™ Companion
35
8.1. PREPARATION .................................................................................................................................. 36
8.2. ACCOMPANYING THE USER ................................................................................................................. 38
8.3. THE COMPANION'S ROLE DURING A GRACEFUL COLLAPSE ........................................................................ 39
9. Cleaning and Maintenance
10. Troubleshooting
11. Repair Policy
12. Technical Specifications
40
48
51
52
12.1. CAPACITIES .................................................................................................................................... 52
12.2. ELECTROMAGNETIC IMMUNITY .......................................................................................................... 53
12.3. RECOMMENDED SEPARATION DISTANCES ............................................................................................ 56
12.4. ELECTROMAGNETIC EMISSIONS ......................................................................................................... 58
12.5. RADIO FREQUENCY (RF) COMMUNICATION SPECIFICATIONS .................................................................... 58
12.6. QUALITY OF SERVICE (QOS) ............................................................................................................. 59
12.7. DATA SECURITY .............................................................................................................................. 59
12.8. COMMUNICATOR DISPLAY SIZE ......................................................................................................... 59
12.9. DAMAGE DUE TO RADIATION............................................................................................................ 59
12.10. FCC COMPLIANCE ........................................................................................................................ 60
12.11. RF INTERFERENCE FROM OTHER DEVICES.......................................................................................... 61
13. Clinical Studies
14. Warranty and Disclaimer
Page 5 of 66
62
66
‎1. Introduction
User Guide
1. INTRODUCTION
1.1. ABOUT THIS USER GUIDE
This User Guide provides the information necessary to operate the Argo ReWalk™ P System.
PLEASE READ THIS USER GUIDE BEFORE OPERATING THE SYSTEM. If any part of this User
Guide is not clear, contact Customer Support for assistance.
1.2. GLOSSARY AND ABBREVIATIONS
BACKPACK
The shoulder-mounted carrying case for the ReWalk computer and other
components
COMPANION
A specially-trained friend or caregiver who can help an independent
ReWalk user in the day-to-day use of the device
COMMUNICATOR
The remote control device used to control the ReWalk
EXOSKELETON
The metal framework that is strapped to the user and which assists the
user in sitting, standing and walking
MODE
The current method of operation of ReWalk. Examples of modes are SIT,
STAND, and WALK.
THERAPIST
A specially-trained medical professional who adjusts the ReWalk to the
individual user, and who helps the user to use the device
USER
The person wearing the ReWalk
Page 6 of 66
User Guide
‎2. System Description
2. SYSTEM DESCRIPTION
2.1. INTENDED USE
The Argo ReWalk™ orthotically fits to the lower limbs and part of the upper body and is intended to
enable individuals with lower limb disabilities to perform routine ambulatory functions in an urban
terrain (stand, walk on level surfaces and mild slopes) to increase their activity level. The ReWalk is
not intended for sports, aggressive use, or stair climbing.
2.2. INDICATIONS
Before using the device, confirm that the following prerequisites are met by the user:







Hands and shoulders can support crutches or a walker.
Healthy bone density.
Skeleton does not suffer from any fractures.
Able to stand using a device such as EasyStand.
In general good health.
Height is between 160 cm and 190 cm (5' 3" - 6' 2").
Weight does not exceed 100 kg (220 lbs).
2.3. CONTRAINDICATIONS
People with the following conditions should not use the ReWalk™- P:








History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc).
Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores.
Severe spasticity (Ashworth 4)
Unstable spine or unhealed limbs or pelvic fractures.
Heterotopic ossification.
Significant contractures.
Psychiatric or cognitive situations that may interfere with proper operation of the device
Pregnant women.
Warning: Crutches are required when using ReWalk™- P.
Page 7 of 66
User Guide
‎3. Safety
3. SAFETY
3.1. TYPES OF WARNINGS, CAUTIONS AND NOTES
Three types of special message appear in this User Guide:
Warning: A warning indicates precautions to avoid the possibility of personal injury or
death.
Caution: A caution indicates a condition that may lead to damage to equipment, or a lower
quality of treatment.
Note: A note provides other important information.
Page 8 of 66
User Guide
‎3. Safety
3.2. GENERAL SAFETY INSTRUCTIONS
General Warnings
DO NOT USE BEFORE READING THIS OPERATION GUIDE.
Changes or modifications not expressly approved by Argo Medical Technologies Ltd. can
affect the safety and effectiveness of the device and will void the system's warranty.
Users must be trained to use the ReWalk™ R. Use of the device without training can
result in serious injury.
The ReWalk™ R must be custom fitted to the User. Software settings must be
customized per User. Use of the device without fitting and customizing can result in
serious injury.
Improper adjustment of device size to suit the user could cause skeletal fractures and
injury to the patient.
The System can collapse due to power cut-off such as a battery malfunction or a
disconnected wire. To minimize the risk of injury, the unit is designed to execute a
graceful collapse as the user has been trained to perform.
Battery malfunctions—such as current leakage, electrical shock during charging, battery
overheating, excessive charging current, etc.—can result in serious injury. To ensure that
this does not occur, do not charge the battery while wearing the device.
To ensure continuous power during use, always charge the battery at the end of the day.
Charge the battery when the ReWalk™ R is turned off but do not charge batteries prior
to air travel – batteries should be minimally charged prior to flight. An indication of
medium charge is when the remote communicator’s icon for the system battery displays
in yellow.
Changing the main and auxiliary batteries should only be done by a trained user or
Companion, following the instructions given in 9.2.2. Inserting the Main Battery and the
Auxiliary Battery. Battery replacement by inadequately trained personnel can result in a
hazard, such as excessive temperatures, fire, or explosion.
The batteries supplied by Argo are specially designed for the ReWalk system. Do not use
other types of batteries.
To avoid system malfunction during use, always test the system’s functionality before
using the device. See 5.3. Activating the ReWalk_P.
Electromagnetic Emissions Interference (EMI) from other electronic devices may cause
loss of system functionality.
Do not attempt to use the device if a software malfunction has caused a total loss of
functionality or if there is a general mechanical failure.
Unintentional mode selection can cause loss of functionality and loss of user control.
This may result in injury.
Using the device on irregular surfaces could result in loss of balance and possible injury.
Do not try to walk on sand, in stony areas, or on any surface that isn’t appropriate for
crutches. Do not use the device on a ramp.
Do not use the device if you are distracted or not paying careful attention to your
operation of the system.
Page 9 of 66
User Guide
‎3. Safety
General Warnings
The device is designed for use with crutches.
Use the device on paved surfaces or on dry, grassy surfaces.
Do not use on an escalator, even with assistance. Escalator irregularities will cause a fall.
Do not attempt to dismantle, open, service, or modify the device, accessories, or
charger. Doing so could present the risk of electric shock or other hazard. Any evidence
of any attempt to open and/or modify this device, including removal of any of the labels,
will void the Limited Warranty.
If a failure is detected while changing from a sitting position to a standing position, the
system automatically returns the user to a sitting position.
The device must be fitted over clothing to prevent skin abrasions. Where necessary, use
the extra padding provided with the device.
Ensure that the device does not put pressure on bony prominences or other bony-like
protrusions.
When removing the ReWalk after use, both the user and where appropriate, the
therapist and Companion, should examine the user’s skin, particularly in those areas
where the device might have been pressing on the user’s body.
If there are signs of abrasions these should be reported to any or all of the following
people: therapist, Companion, trainer, and/or the health care professional if the latter is
involved.
ByPass mode should be used with caution and only if the communicator has
malfunctioned.
Changes or modifications not expressly approved by Argo Medical Technologies Ltd. can
affect the safety and effectiveness of the device and will void the system's warranty.
Changes or modifications not expressly approved by Argo Medical Technologies Ltd. can
affect the safety and effectiveness of the device and will void the system's warranty.
The device contains no user-serviceable components.
Electrical shock and flammability hazard – Cleaning the device should be limited to the
simple procedure discussed in Section Error! Reference source not found.. For any
additional cleaning or servicing, always consult Argo Medical Technologies Ltd.
Electrical shock hazard – Do not remove the cover from any components of the
system. An operator may only perform maintenance procedures specifically
described in this Operation Guide. Refer servicing to qualified service personnel
trained in the repair of this equipment.
Page 10 of 66
User Guide
‎4. System Components
General Cautions
Disposal of this device should be performed in accordance with local regulations.
If the device is not working correctly, discontinue use and refer servicing to qualified
service personnel.
Do not disassemble any part of the system components. This system is not userserviceable.
3.3. SAFETY STANDARDS
The device complies with the following standards for general requirements of medical electrical
equipment safety:
IEC 60601-1 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and
Essential Performance
IEC 60601-1-2 – Medical Electrical Equipment - Part 1: General Requirements for Safety 2. Collateral
Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-11 – Medical Electrical Equipment -- Part 1-11: General Requirements for Basic Safety
and Essential Performance -- Collateral Standard: Requirements for Medical Electrical Equipment
and Medical Electrical Systems Used in the Home Healthcare Environment
IEC 61000-4 – Transient Immunity Standards
FCC 47 CFR Part 15 –Telecommunication/Radio Frequency Devices
3.4. SYMBOLS USED IN THIS GUIDE
Symbol
Symbol Meaning
Caution , consult accompanying documents
US federal law restricts this device for sale by or on the order
of a physician
Consult instructions for use
Manufacturer
Not for general waste
Shock protection (B, BF, CF)
RF radiation
Page 11 of 66
User Guide
‎4. System Components
4. SYSTEM COMPONENTS
WHAT ARE THE PARTS OF THE ARGO REWALK?
This section of the User Guide describes the various components of the system.
The Argo system consists of three main components:
 Communicator
 Exoskeleton
 Backpack.
In addition, the system includes a Charger for recharging the batteries when the system is not in use.
The Exoskeleton is the
flexible supporting
framework that helps
you to sit, stand and
walk.
The Communicator is a
lightweight remote
control that provides
instructions and
guidance in using the
system. It is worn on the
wrist.
Page 12 of 66
The Backpack contains
most of the system's
electronic parts and
batteries. It is worn like
a conventional
backpack.
The Battery Charger
is used to charge the
system. It is typically
used for overnight
charging.
‎4. System Components
User Guide
The following sections discuss each component in detail.
4.1. THE COMMUNICATOR
The Communicator is the wireless remote control for the ReWalk. It is worn on the wrist.
Details of front panel:
1.
2.
3.
4.
Mode icons
Previous button
Select button
Next button
Note: The Communicator enters Sleep mode when it is not used for a period of time. Press
the large Select button to wake the Communicator. The icons will flash briefly.
4.1.1. COMMUNICATOR WARNINGS AND INDICATORS
The Communicator has several Warning signals that indicate a system requirement or a required
action.
COMMUNICATION FAILURE/GENERAL WARNING
This signal indicates that the Communicator cannot communicate with the system.
It is possible that the system battery is not charged, or their could be some other
problem with the device. Try charging the system. If that does not clear up the
problem, contact Argo support.
BATTERY INDICATORS
The system contains two sets of batteries: the Communicator batteries, located inside the
Communicator, and the system batteries, located inside the backpack.
Communicator battery indicator
System battery indicator
Page 13 of 66
‎4. System Components
User Guide
BATTERY INDICATIONS
The following table explains the meaning of the various battery indicator values.
COMMUNICATOR BATTERY INDICATIONS
Indicator Color
Communicator
Battery
System Battery
Action
Green
Battery normal
Battery normal
None
Yellow
Battery medium
Battery medium
None
Red
Battery low
Battery low
10 minutes remaining.
Exit system and charge
batteries
Red flashing
Battery very low
Battery very low
Exit system
immediately and
charge batteries
Flashing red, or
red and green
or green with
charger
connected to
communicator
Charging
NA
None
Note: A flashing RED Warning Icon indicates the loss of communication
between the Communicator and the Onboard Computer (see 4.3.1. The
Onboard Computer).
A solid RED Warning Icon, displayed with any other icon, indicates a stuck
leg that must be released by the therapist/user. If, after releasing the leg,
the Red warning icon stays on, this could indicate a malfunction. You should
contact technical support.
Page 14 of 66
‎4. System Components
User Guide
4.1.2. SELECTING A COMMUNICATOR MODE
The following table shows the icons that represent the various modes for the ReWalk™- P.
Note: Movement between modes is restricted. You can only move to a mode that the
ReWalk™- P can accommodate. For example, you can move from SIT to STAND. However,
you cannot move from SIT to WALK.
Communicator Icons and Components
SIT
STAND
WALK
MANUAL
When in the above modes, you can move to the
following modes:
STAND
or MANUAL
WALK
or SIT
STAND
mode only
MANUAL
mode only
available*
* With the system in Manual mode, to exit Manual
mode, reselect the Manual icon. The system will exit
Manual mode and the Communicator will display the
Sitting mode.
To select a mode:
Press any button to activate the Communicator. The icon of the current mode is colored green.
Press the Next/Previous button. One icon flashes. This represents the mode that the ReWalk™- P
will shift to and the mode that you most likely want to select. The icons of other available modes are
solid yellow.
There are two possibilities:
 If the flashing icon is the mode you want to move to, press Select.
 If the flashing icon is not the mode you want to move to, use the Previous and Next buttons.
When the icon of the mode you want to select is flashing, press Select.
The Onboard Computer emits a beep and a short vibration confirming that it has received the
communication and enters the new mode, which is displayed in green.
Page 15 of 66
User Guide
‎4. System Components
4.2. THE EXOSKELETON
The exoskeleton is the flexible supporting
structure that allows you to sit, stand and walk.
Components of the Exoskeleton
Item
Description
Backpack
Chest Strap
Waist Strap
Thigh Straps
Upper Knee Straps
Lower Knee Straps
Ankle Straps
Tilt Sensor
4.3. THE BACKPACK
The backpack is worn like a regular backpack or knapsack and contains most of the ReWalk™- P
electrical components.
Components of the Backpack
Page 16 of 66
Item
Description
Vibrator
Main Battery
Backup Battery
Onboard Computer
‎4. System Components
User Guide
4.3.1. THE ONBOARD COMPUTER
The Onboard Computer provides audible alerts and vibrations to tell you what is happening in the
system.
Audible Alerts and Vibrations Before Use
Alert
Cause
Long beep and vibration after
turning on the ReWalk™- P
Response
Internal test failed. Wait a few seconds. If the beeper does not
stop beeping, turn off and on the device. If
the situation repeats itself, report it to a
service center.
Ensure that the system batteries are charged.
Warning: One of the batteries is disconnected or discharged.
Audible Alerts and Vibrations During Use
Alert
Cause
Response
One short vibration and beep
repeated every 5 seconds
Low battery
10 minutes remaining. Exit system and charge
batteries.
One beep and vibration
during use
-High power usage
-High power usage
could be caused by
excessive friction
between floor and
the user’s foot.
While standing up or sitting down, the unit
switches to SIT mode and sits the user down.
Obstacle in path or
limb is dragging.
Overheating
batteries.
Withdraw limb. If this does not help, seek
help and contact technical support.
Long beep and
vibration
User notes that system relaxes pressure on
the affected joints. User should reseat
himself/herself firmly on chair to avoid falling.
While in manual mode the system freezes.
Select Manual mode on RC - the device exits
Manual mode & transfers to SIT mode.
One short vibration and beep Technical fault.
repeated every 1 or 5 seconds Very low battery
depending on whether the
level.
batteries are low or very low
Exit the system immediately and charge
batteries.
Three repeating beeps while
walking
Tilt your body to release the immobilized leg.
Page 17 of 66
High power usage
‎4. System Components
User Guide
NORMAL USE in STANDARD ORDER
Alert
Indication
Response
One short vibration and beep
Device power ON
One short vibration and beep
Received new mode
and activated
Three short vibration and beeps
Device is about to
stand
Perform sit-to-stand procedure
One short vibration and beep
during a walk
Ready for tilt
Perform a tilt as instructed
Three short vibration and beeps
Device is about to sit
Perform stand-to-sit procedure
4.3.2. CHARGING THE SYSTEM BATTERIES AND THE COMMUNICATOR
The ReWalk™- P uses three types of batteries: the Communicator batteries, the primary system
battery, and the backup system battery. In order to prolong battery life and get the maximum use of
the system, the batteries should be fully charged after use. A full battery charge takes about seven
hours.
Warning: If any of the batteries is not functional (connection problem, low charge or other
difficulty) the system will not operate. Do not attempt to proceed.
Warning: Charge the battery when the ReWalk™- P is turned off. Do not charge batteries before
air travel - batteries should be minimally charged prior to flight. An indication of medium charge
is when the remote communicator’s icon for the system battery displays in yellow.
Warning: Use only the charging units provided with the Argo ReWalk P.
CHARGING THE SYSTEM BATTERIES
Warning: Do not charge the batteries when the ReWalk™- P
is on. Doing so will damage the ReWalk™- P.
Note: Both the main battery and the backup battery are
charged via the single charging port on the Onboard
Computer in the backpack.
To charge both system batteries:
1. Ensure that the ReWalk™- P is turned off.
2. Ensure that the charger is unplugged from the wall-socket.
3. Open the backpack’s On/Off and Charging window.
4. Observe that the 8-pin connector has an alignment node.
5. Align the 8-pin connector with the charging port within the backpack.
6. Connect the charger to the Onboard Computer within the backpack.
Page 18 of 66
‎4. System Components
User Guide
Alignment Node
Eight Pin Connector
Attached to the Onboard
Computer through the
On/Off and Charging
Window
7. Connect the charger to the wall socket. The charger can be plugged into either a 110V (United
States) or a 220V outlet.
8. Continue charging procedure until the the green LED indicator displays (no damage can be
caused if the onboard computer is still connected to the charger at this stage).
9. When charging is completed, first disconnect the charger from the wall socket and only then
disconnect it from the Onboard Computer.
LED Behavior/
Color
Off
Explanation
Batteries are not connected to the charger or the charger is not
plugged into the outlet.
Yellow, transitioning to green
The batteries are charging. As the battery becomes more fully
charged, the yellow shade gradually turns to a darker shade of green.
Green
Finished charging. The batteries are full.
CHARGING THE COMMUNICATOR
Charging the Communicator takes about five hours. The Communicator charger is a regular charging
device, as shown below.
Warning: Use only wall-mounted 110V-240V mains.
To charge the Communicator:
1. Plug the charging unit into an outlet.
2. Plug the Communicator into the charging unit.
Communicator Charging Unit
Communicator Charging Port
The Communicator battery icon will flash green as the Communicator is charging. When it is fully
charged, the icon will be solid green.
Page 19 of 66
User Guide
‎5. Moving Into the ReWalk
5. MOVING INTO THE REWALK
This section of the User Guide explains how to put on and secure the Argo Rewalk. It also
explains how to activate the device, and how to remove it.
Your Companion will adjust the size of the ReWalk™- P to match your body and secure your
designated ReWalk™- P shoes in the foot supports. The therapist will also configure the sensors and
other software parameters.
Warning: The device must be fitted over clothing to prevent skin abrasions. Where
necessary, use the extra padding provided with the device.
Warning: Ensure that the device does not put pressure on bony prominences or other
bony-like protrusions.
Note: Remember to bring your specially fitted ReWalk™- P straps and shoes with you.
5.1. PREPARATION
Following the fitting and configuration process, you must learn how to get into, and out of, the unit.
1. Before beginning the move:
• Ensure that your crutches are within arms reach. Crutches are required when using ReWalk™- P.
• Ensure that your clothing is appropriate. Wear clothing that is neither tight nor loose. Do not
wear dresses, skirts or other long clothing.
• Affix the Communicator to your wrist.
Communicator on Wrist
2. Ensure that the ReWalk™- P is placed on a chair with a width of at least 50 cm (24 inches).
The characteristics of an appropriate chair are:
• No arm-rests
• Does not tip forward
• Sturdy enough to support the user and the system which weighs 25 kg (55 lbs)
Page 20 of 66
User Guide
‎5. Moving Into the ReWalk
3. Ensure that the straps of the ReWalk™- P are open and that the thigh straps are dangling.
Thigh straps in preparation for move
4. Place the wheelchair alongside the ReWalk™- P.
5. Engage the wheelchair’s brakes.
6. Test the stability of the chair.
7. While doing the following action, if necessary, request your Companion to stabilize the device: lift
your body and move from the wheelchair to the ReWalk™- P.
You might need to rest on a segment of the ReWalk as you are moving: take care not to damage the
ReWalk™- P.
8. Remove your shoes and place your feet into your ReWalk shoes.
9. Align your legs and make sure that both your feet are in firm contact with the floor prior to
standing.
Your Position in the ReWalk™- P
Page 21 of 66
User Guide
‎5. Moving Into the ReWalk
5.2. SECURING THE REWALK™- P
Several straps secure the ReWalk™- P to your body. When securing the straps ensure that you use
adequate padding (supplied) to prevent abrasions and skin injury that could occur if the padding is
insufficient. The straps should be fastened snuggly to your body.
Warning: Excessive tightening may cause discomfort, vascular occlusion, and edemas or
pressure wounds. For catheter users, excessive tightening could cause blockage. Ensure
there are no kinks in the tubing.
1. Close your shoes and secure the ankle straps.
2. Secure the straps below the knees.
3. Secure the straps above the knees.
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User Guide
‎5. Moving Into the ReWalk
4. Secure the thigh straps.
5. Secure the waist and chest straps.
6. Put on the backpack and secure the backpack straps.
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‎5. Moving Into the ReWalk
5.3. ACTIVATING THE REWALK_P
Turn on the ReWalk™- P, as pictured below. The ReWalk™- P On/Off switch is located in the
backpack.
Turning on the ReWalk-P
Warning: If a continuous beep is heard when activating the ReWalk , prepare yourself for
sitting and switch off the device.
Warning: When you turn on the device, the system vibrates to indicate that it is
functioning normally. If you do not feel this vibration, do not use the device. Contact
Argo support for assistance.
Warning: If the On/Off switch cannot be moved freely to the ON or OFF position, do not
use the device.
In the context of a continuous beep being heard, the RC will display an error message. Having
switched off the device, attempt to restart the ReWalk. If the restart is not successful, contact Argo
technical services.
If the system restarts, this is an indication that the error was caused by improper use.
Note The system passes through various pretests as it starts up. If there is a system
failure a red triangle and the manual icon will display. If this happens, call your service
center.
Warning: Do not charge the batteries when the ReWalk™- P is on. Doing so will damage
the ReWalk™- P.
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‎5. Moving Into the ReWalk
5.4. REMOVING THE REWALK
Warning: When removing the ReWalk after use, both the user and where appropriate,
the therapist/Companion, should examine the user’s skin particularly in those areas
where the device might have been pressing on the user’s body. If there are signs of
abrasions, these should be reported to any or all of the following people: therapist,
Companion, trainer, and/or the health care professional if the latter is involved.
To remove the ReWalk™- P:
1. Sit down. Do not try to remove the ReWalk™- P while standing.
2. Remove the backpack.
3. Remove the straps from chest to ankle, in this order:
a. Remove the chest strap.
b. Remove the waist strap.
c. Remove both thigh straps.
d. Remove both upper knee straps.
e. Remove both lower knee straps.
f. Remove the ankle straps.
4. Remove your feet from the shoes.
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User Guide
‎6. Using the Argo ReWalk
6. USING THE ARGO REWALK
This section of the User Guide shows you how to use the Argo ReWalk to sit, stand and walk.
Now that you are familiar with the Argo ReWalk, you can begin to operate the system.
6.1. TWO RULES OF THE COMMUNICATOR
The Communicator is very easy to use once you learn these two rules:
1. 100% of the time, you must press at least twice.
First, you press the Select button to activate the Communicator. Next, you must make a selection.
2. The flashing icon is the one that will be selected.
After you activate the Communicator:
• The icon of the current mode is colored solid green.
• One icon flashes yellow; it represents the mode that the ReWalk™- P will shift to—and the mode that
you most likely want to select—if you push the Select button.
• The icons of other available modes are solid yellow.
There are two possibilities:
• If the flashing icon is the mode you want to move to, press the Select button right away.
• If the flashing icon is not the mode you want to move to, use the Previous and Next buttons. When the
icon of the mode you want to select is flashing, press the Select button.
The Onboard Computer emits a beep confirming that it has received the communication. As the ReWalk™P is entering the new mode, the icon flashes.
We recommend that you familiarize yourself with the mode icons and the operation buttons on the
Communicator. These are explained in the table "Communicator Icons and Components" in 4.1.2.
Selecting a Communicator Mode.
Note: Movement between modes is restricted. You can only move to a mode that the
ReWalk™- P can accommodate. For example, you can move from SIT to STAND.
However, you cannot move from SIT to WALK.
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‎6. Using the Argo ReWalk
User Guide
6.2. STANDING UP
To stand up:
1. Ensure that your feet touch the ground. If they do not, adjust the position of the legs using
MANUAL Mode (see 7.1. Manual Mode).
2. Ensure that you are in SIT mode. You can only stand up from SIT mode.
3. Take the crutches. The crutches need to be behind you as you stand up.
4. Set the Communicator to STAND mode:
a. Press any button to activate the Communicator.
b. Press the Next/Previous button, the STAND icon flashes yellow.
c. Press the Select button to confirm the choice.
5. Place the crutches behind you.
6. Ensure that there is adequate ROM (range of motion) for your shoulders. Before standing you up, the
following occurs:
• The unit waits three seconds to allow you to position the crutches.
• After three seconds, the Onboard Computer emits three short beeps and vibrates.
Note: While the device stands you up, the STAND mode icon flashes green.
Once it has entered STAND mode, the STAND icon changes to solid green.
Note: If the device does not perform as expected, a beep is sounded indicating
a problem. This could be due to the position of your legs on the floor. Ensure
that your knee alignment is within the 70-100 degree range. Restart the
standing procedure.
7. The ReWalk™- P stands you up and enters STAND mode. Stabilize yourself.
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Standing up
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User Guide
‎6. Using the Argo ReWalk
6.3. SITTING DOWN
To sit down:
1. Ensure that you are in STAND mode. You can only sit from STAND mode.
2. Set the crutches behind you. Ensure that there is adequate ROM (range of motion) for your
shoulders.
3. Set the Communicator to SIT mode:
a. Press any button to activate the Communicator.
b. Use the Previous and Next buttons to shift focus to the SIT mode. When in focus, the SIT icon
flashes yellow.
c. Press the Select button to confirm the choice.
4. Prepare to sit down. Before sitting you down the following occurs:
• The unit waits three seconds to allow you to position the crutches.
• After three seconds, the Onboard Computer emits three short beeps and vibrates.
Note: While the device is sitting you down, the SIT mode icon flashes green. Once it has
entered SIT mode, the SIT icon changes to solid green
5. The ReWalk™- P sits you down and remains in SIT mode.
Note: While in SIT mode, if a beep is sounded this indicates that you are not sitting
correctly. You should be seated well back on the chair so that there is no pressure on
your knees. Ensure that your feet are together, firmly on the floor.
Sitting down
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‎6. Using the Argo ReWalk
6.4. WALKING
Warning: Do not try to walk on sand, in stony areas, or on any surface that isn’t
appropriate for crutches. The device is designed for use with crutches. Use it on paved
surfaces or on dry, grassy surfaces.
Do not try to get on an escalator, even with assistance. Escalator irregularities will cause
a fall.
Do not use the ReWalk™- P in the rain. Water will cause significant damage to the
system.
To walk:
1. Stand up (see 6.2. Standing Up).
2. Set the Communicator to WALK mode:
a. Press any button to activate the Communicator.
b. Press Next/Previous button, the WALK mode icon flashes yellow.
c. Press the Select button to confirm the choice. The WALK icon changes to green and stops
flashing.
3. Activate WALK by moving both crutches forward. This action is called a "tilt". ReWalk™- P senses
the tilt and moves the right leg first. Again, move both crutches forward. ReWalk™- P moves the left
leg in front of the right leg.
4. Repeat step 3. Each movement of the crutches (tilt) results in a ReWalk™- P step.
Note: In the event you bump into something, the system reverts to STAND mode.
Similarly, if you pause or if ReWalk™- P does not sense a tilt within the time specified on
the user interface, the system will automatically revert to STAND mode.
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‎7. Manual and Bypass Mode
User Guide
7. MANUAL AND BYPASS MODE
Argo-ReWalk provides two special modes of operation for the user: MANUAL mode and BYPASS mode:


MANUAL mode is only accessible from SIT mode and is used to control the joints manually without
relying on the automated system.
BYPASS mode is used if there is a problem with the Communicator but the user must still operate
the system.
Warning: Manual mode should be used only for adjusting the leg position while sitting or
in an emergency situation. Do not remain in manual mode longer than needed for the
adjustment and when the adjustment is completed, change back to sit mode.
Warning: While in SIT mode, if a beep is sounded this indicates that the device has
detected "high power" and the device will relax pressure on the affected joints.
7.1. MANUAL MODE
1. Set the Communicator to MANUAL:
a. Press any button to activate the Communicator.
b. Use the Previous and Next buttons to shift focus to the MANUAL mode. When in focus, the MANUAL
mode icon flashes yellow.
c. Press the Select button to confirm the choice. The MANUAL mode icon changes to green and stops
flashing.
2. Each of the four ReWalk™- P segments has two manual buttons. Press one of the buttons.
• The upper button moves the segment forward.
• The lower button moves the segment back.
Upper Button
Lower Button
Manual Mode buttons
3. To exit MANUAL mode, select the Manual icon (see step 1 above).
Note: If there is excessive friction between the floor and your foot while performing this
procedure, a beep will sound and you will feel some vibration due to the device using
high current. The device stops working. Proceed as follows: Change to SIT mode, ensure
there is no friction with the floor and then revert to MANUAL mode.
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‎7. Manual and Bypass Mode
User Guide
7.2. BYPASS MODE
BYPASS mode is intended to handle situations when there is a loss of communication and the user
realizes that he/she cannot operate the ReWalk.
Bypass enables the user to operate the system without using the Communicator. Bypass mode can only be
activated when in a sitting/standing position or while in Manual mode.
Warning: BYPASS mode should be used with caution and only if the communicator has
malfunctioned.
The Bypass buttons are located on the device’s hip and knee segments, as shown below.
Hip Up button - Walk
Hip Down button - Sit/Stand
Knee Up button
Knee Down button
Bypass manually-operated buttons
7.2.1. MODE SELECTION
Bypass Mode
• On the hip segment (either left or right), press both buttons simultaneously for two seconds; a long beep
is sounded. The system enters Bypass mode.
Sitting/Standing Mode Selection
• Press lower hip button twice for two seconds to bring the system to a sitting\standing position
depending on the system’s current position i.e. if the system is in a standing position, the system enters a
sitting position and visa versa.
Note: Complete activation of the hip buttons within 10 seconds.
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‎7. Manual and Bypass Mode
Walking Mode
1. Proceed to walk mode from a standing position.
2. Press the upper hip button for two seconds. A beep is sounded.
3. Start walking.
Manual Mode
Manual mode enables you to operate each segment of the system individually and can only be invoked
from a sitting position.
Press the upper knee button for two seconds. A beep is sounded and the system enters manual mode.
Exiting Manual Mode
• On the knee segment (either left or right), press both buttons simultaneously for two seconds; a long
beep is sounded. The system exits Manual mode.
Exiting Bypass mode
• On the hip segment (either left or right), press both buttons simultaneously for two seconds; a long beep
is sounded. The system exits Bypass mode and reestablishes communication with the Communicator.
7.3. GRACEFUL COLLAPSE
Warning: Graceful Collapse is a critical safety feature and requires careful execution. The
User and/or Companion should be prepared to have a chair and appropriate padding on
hand to protect the user if Graceful Collapse is invoked.
If the ReWalk encounters a fatal error, the device will power off and enter a "Graceful Collapse". Graceful
Collapse will also occur if the power is switched off.
During Graceful Collapse, the device will support the user's weight while slowly lowering the user to a seat
or the ground. The user’s Companion can then assist the user by positioning a seat under the ReWalk. The
user can then remove the ReWalk and transfer to a wheelchair.
See 8.3. The Companion's Role During a Graceful Collapse for an explanation of the Companion's actions
during a Graceful Collapse.
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User Guide
‎8. The ReWalk™ Companion
8. THE REWALK™ COMPANION
FOR THE COMPANION …
This section of the User Manual explains how the user's Companion can help him to use the
Argo ReWalk.
The ReWalk is designed for independent use, however we recommend that every ReWalk user, no matter
how skilled, should have a trained ReWalk Companion such as a family member, friend or caregiver.
The first role of the Companion, after completing a basic training course at a trainer center, is to
accompany and assist the user in practicing and using the ReWalk.
The Companion’s second role is to assist the user in situations where the potential risk is high, e.g. walking
on an uneven surface.
The user is responsible for deciding whether to use the ReWalk with or without a Companion, based on
self-judgment of her/his ability and confidence.
In this section, specifically written for the Companion:


The Companion is the person assisting the user
The friend is the ReWalk user.
Warning: This section is intended for reference only. It does not constitute a Companion
training course and cannot substitute for adequate Companion training. The Companion
must undergo training in a formal Argo Companion Training course
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‎8. The ReWalk™ Companion
8.1. PREPARATION
The user should wear appropriate clothing that is neither tight nor loose. Clothing that may interfere
with wearing and using the ReWalk™ such as dresses, skirts or other long items should not be worn.
To secure the ReWalk™ device on the user, the device is supplied with customized straps specially
prepared for the user. For more information about the straps, see 5.2. Securing the ReWalk™- P.
8.1.1. THE SHOES
During training, specific shoes were approved for use with the ReWalk™. Make sure your friend is
using only those specifically approved for use with the device. You will need to attach the shoes to
the ReWalk™- P. Following is a summary of the procedure:
1. Remove the inner soles from the shoes.
2. Put the shoes on the unit's shoe-support bases.
3. Attach the shoes to the unit’s shoe supports.
4. Return the inner soles to their position in the shoes.
8.1.2. DRESSING THE UNIT ON THE USER
Warning: Ensure that the device does not put pressure on bony prominences or other bonylike protrusions.
The ReWalk™ has previously been sized to fit your friend and so the next step is to move the user
into the unit and fasten the unit on your friend.
Before you start:
1. Place the ReWalk™ on a sturdy chair that does not have arm supports and that cannot tip
forward easily.
2. Arrange the ReWalk™ straps so that the user does not sit on them during the positioning
process.
Your friend has already been trained to move from the wheelchair to the chair that the device is
resting on. However, you need to know how your friend is going to make the move so that you can
help if the need arises.
There are two ways of moving from the wheelchair into the supporting chair. Some users will be able
to swing themselves over onto the chair. Other users will need your assistance.
DRESSING THE UNIT ON THE USER – FOR INDEPENDENT USERS
Briefly explain the transferring movement that your friend is now going to perform, which involves
lifting oneself and swinging over to the supporting chair.
1. Place the wheelchair alongside the ReWalk™ and ensure that the wheelchair's brakes are now
engaged.
2. Shoes should be removed so be ready to assist as needed.
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3. If necessary, stabilize the chair during this maneuver.
4. Ensure that the user does not place his/her grip on a segment of the ReWalk™ that could be
damaged.
5. Assist your friend placing their feet into their shoes and fasten the shoe laces.
6. Align legs on the ReWalk™.
7. Fasten your friend to the ReWalk™ using each of the eleven straps provided for this purpose
ensuring that each of them is fastened snuggly but comfortably.
Warning: Be very careful not to over-tighten the straps. Excessive tightening may cause
discomfort, vein or artery occlusion, and edemas or pressure wounds.
Warning: For catheter users, ensure that the tubing is not kinked.
8. Finally, assist your friend putting on the backpack and secure it.
DRESSING THE UNIT ON THE USER – FOR USERS REQUIRING ASSISTANCE
Some ReWalk™ users are not able to transfer independently from their wheelchair to the chair
supporting the ReWalk™. In this instance, you will need to assist your friend. You should review this
procedure with your local ReWalk™ trainer.
Once your friend is positioned in the ReWalk™, proceed with Steps 5 through 8 above.
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User Guide
‎8. The ReWalk™ Companion
8.2. ACCOMPANYING THE USER
This section describes what you need to know when you are out on a ReWalk excursion.
8.2.1. THE COMMUNICATOR
From time to time, you may have to operate the Communicator. We strongly recommend that you
familiarize yourself with the Communicator and its various operational modes. For a complete
explanation of the Communicator, see 4.1. The Communicator and see 6.1. Two Rules of the
Communicator. Following is a brief description of how to use the Communicator:




Press any button to activate the Communicator.
o The icon of the current mode is colored green.
Press the Next/Previous button.
o One icon flashes. This represents the mode that the ReWalk™- P will shift to and the
mode that you most likely want to select.
o The icons of other available modes are solid yellow.
There are two possibilities:
o If the flashing icon is the mode you want to move to, press Select
o If the flashing icon is not the mode you want to move to, use the Previous and Next
buttons. When the icon of the mode you want to select is flashing, press Select.
The Onboard Computer emits a beep and a short vibration confirming that it has received
the communication and enters the new mode, which is displayed in green.
COMMUNICATOR – MANUAL MODE
Your friend has been trained to use the RC. Manual Mode is additional functionality which can be
activated only while in SIT mode. This controls the ReWalk segments independently of the device’s
software.
To set the Communicator to Manual mode:
1. Press the large Select button to activate the Communicator.
2. Use the Previous/Next buttons to scroll to the MANUAL mode. The MANUAL mode icon flashes
yellow.
3. Press the Select button to confirm the choice. The MANUAL mode icon changes to green and
stops flashing.
Each of the four ReWalk segments has two manual buttons. The upper button moves the segment
forward. The lower button moves the segment back.
8.2.2. MECHANICAL AND MEDICAL ALERTNESS
As the Companion accompanying your friend, you should be in tune with your friend’s general
condition of health prior to beginning and should assess the surrounding area before setting out on
a ReWalk™ outing.
When removing the ReWalk after use, both the user and the Companion, should examine the user’s
skin particularly in those areas where the device might have been pressing on the user’s body. If
there are signs of abrasions these should be reported to any or all of the following people: therapist,
Companion, trainer, and/or the health care professional if the latter is involved.
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‎9. Cleaning and Maintenance
In particular:


When accompanying your friend, it is important to walk next to the individual and choose
to walk with your dominant (stronger) hand adjacent to the ReWalk.
Be aware of and alert your friend with regard to obstacles, rugs, doors, and ramps etc.
that lie ahead. Give your friend ample time to adjust to changes in the pathway as you
proceed.
ALERTS FOR MECHANICAL MALFUNCTION
In the unlikely event of a mechanical malfunction, first and foremost secure your friend offering
physical support and give assurance to maintain your friend’s confidence.
Do the following:
1. If the ReWalk™ device does not respond, power down the device and assist your friend to sit
on a chair.
2. While assisting your friend, hold on to the pelvic belt section of the ReWalk™.
3. Assess the malfunction as per the user guide illustrations and determine how to get the unit
operational.
8.3. THE COMPANION'S ROLE DURING A GRACEFUL COLLAPSE
Warning: Graceful Collapse is a critical safety feature and requires careful execution. The
user and/or Companion should be prepared to have a chair and appropriate padding on
hand to protect the user if Graceful Collapse is invoked.
If the ReWalk encounters a fatal error, the device will power off and enter a "Graceful Collapse".
Graceful Collapse will also occur if the power is switched off.
During Graceful Collapse, the device will support the user's weight while slowly lowering the user to
a seat or the ground. The Companion can then assist the user by positioning a seat under the
ReWalk. The user can then remove the ReWalk and transfer to a wheelchair.
Graceful Collapse notes for the Companion
1. The user stands wearing the ReWalk with crutches providing support.
2. The user is accompanied by the Companion, who locates himself behind the user to
ensure the user’s safety.
3. The Companion provides a verbal cue to the user that the unit will be temporarily
switched off.
4. The Companion switches off the ReWalk and allows the user to slowly descend until a sitting
position is reached.
5. The Companion then assists the user to remove the device and transfer to a wheelchair.
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User Guide
‎9. Cleaning and Maintenance
9. CLEANING AND MAINTENANCE
9.1. CLEANING
Note: Do not use acetone-based products to clean the ReWalk™- P.
System surfaces that touch the body may be cleaned periodically using a dampened cloth with an
alcohol-based disinfectant.
Warning: If the device is used by more than one user, it is essential to clean the device with
disinfectant before use.
Straps that are torn, worn, or contaminated should be discarded and replaced with new ones.
9.2. BATTERY CARE
Correct battery care is essential for providing safe use of the ReWalk for the maximum useful battery
life.
9.2.1. BATTERY CHARGING
Follow these guidelines for optimum battery charging:
• Charge batteries before each use.
o The preferred method is to charge the battery overnight after each use.
• In the event that the ReWalk is not to be used for an extended period of time,
the system should be charged overnight once a week. You may also leave the battery pack
in the charger.
Warning: Battery malfunctions—such as current leakage, electrical shock during
charging, battery overheating, excessive charging current, etc.—can result in serious
injury. To ensure that this does not occur, do not charge the battery while wearing the
device.
Warning: To ensure continuous power during use, always charge the battery at the end
of the day.
Warning: Charge the battery when the ReWalk™ R is turned off but do not charge
batteries prior to air travel – batteries should be minimally charged prior to flight. An
indication of medium charge is when the remote communicator’s icon for the system
battery displays in yellow.
Changing the main and auxiliary batteries should only be done by a trained user or
Companion, following the instructions given in 9.2.2. Inserting the Main Battery and the
Auxiliary Battery. Battery replacement by inadequately trained personnel can result in a
hazard, such as excessive temperatures, fire, or explosion.
The batteries supplied by Argo are specially designed for the ReWalk system. Do not use
other types of batteries.
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‎9. Cleaning and Maintenance
9.2.2. INSERTING THE MAIN BATTERY AND THE AUXILIARY BATTERY
1. Locate the Main Battery you will be installing into the backpack.
2. Gently slide the Main Battery into the large pouch with the left side opening, taking care to
ensure the battery cable is exiting at the bottom left corner of the pouch.
3. Close the Velcro flap to secure the Main Battery in its pouch and route the battery cable
down towards the INF Computer.
Caution: Improper battery connections can result in device damage or failure. Please follow
the next steps very carefully!
4. Locate the Main and Aux Battery connector terminals on the INF Computer.
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‎9. Cleaning and Maintenance
5. Insert the connector for the Main Battery cable into the terminal labeled “Main” on
the INF Computer. You will hear a “click” when the connector is fully seated.
6. Now locate the Aux Battery you will be installing into the backpack.
7. Gently slide the Aux Battery into the small pouch on top of the Main Battery
pouch, taking care to guide the battery cable connector through the hole in
the upper right corner at the back of the pouch.
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‎9. Cleaning and Maintenance
8. Close the Velcro flap to secure the Aux Battery in its pouch and route the battery cable down
to the INF Computer.
9. Insert the connector for the Aux Battery cable into the terminal labeled “Aux” on the INF
Computer. You will hear a “click” when the connector is fully seated.
10. Once both Main and Aux Batteries are installed, double check your connections and the
security of the battery packs in their pouches. The correct final install should look like this:
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‎9. Cleaning and Maintenance
11. Close the backpack cover taking care not to pinch the cables in the zippers.
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‎9. Cleaning and Maintenance
9.2.3. REMOVING THE MAIN BATTERY AND THE AUXILIARY BATTERY
Note: The Main Battery and the Auxiliary Battery should be removed by the user when
the device is being prepared for shipping, or if the device will be stored for a long period
of time.
1. Open the Backpack to gain access to battery packs.
2. Locate Main and Aux battery connections on the INF Computer (grey box).
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‎9. Cleaning and Maintenance
3. Disconnect the Aux Battery connector from the INF Computer by
depressing the tab on the top of the connector while gently
pulling the connector out.
4. Open the Velcro flap holding the Aux Battery in its pouch to allow for removal
5. Carefully guide the Aux Battery cable through the opening at the
back of the pouch as you slowly pull the Aux Battery out of the
pouch so as to avoid damaging the wiring or connector
6. Once the Aux Battery is completely removed, disconnect the Main
Battery cable from the INF computer using the same procedure as with
the Aux Battery
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‎9. Cleaning and Maintenance
7. Once the Main Battery cable is disconnected, open the Velcro flap
holding the Main Battery in and gently pull it out of its pouch.
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User Guide
‎10. Troubleshooting
10. TROUBLESHOOTING
This section includes a guide to troubleshooting various operational incidents, describes the
symptoms, possible causes and gives an explanation how to fix them if these occur.
Symptom
Cause
Fix
Rewalk system battery does
not charge
Onboard computer (INF)
Verify that system is off.
Connection to charger
Verify charging connector is
properly connected.
Charger failure
Verify both charger LEDs are
orange and green after 8 hours.
Battery failure
If problem persists contact your
distributor or technical support.
Connection to charger
Verify that plug is OK and
properly inserted in unit.
Charger failure
Swap chargers/RC if more than
one unit is used.
Charger is connected to
INF
Disconnect charger from INF and
from mains.
Batteries low
Charge batteries.
System does not stand
Knee alignment out of
70-100 degree range
Move knee to 90 degrees.
System does not walk
Communication error
See Communication
error below.
Tilt error
On user interface from Online data
tab, click "Collect Data" to "On"
and verify that the Tilt settings
update. If the settings do not
update, contact your distributor or
technical support.
Low current walk
threshold
Increase current threshold in
interface.
Low batteries
Charge batteries
Remote Communicator
battery does not charge
System does not power up
High frequency beeps every
5 seconds
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‎10. Troubleshooting
User Guide
Symptom
Cause
Fix
Noisy system during
operation
Loose screws
Check all system screws and
tighten as needed.
Noisy ankle joint
Lubricate ankle joint
Start Up self test failure long beep after power up
Tilt failure, or one of the
connectors not correctly
inserted into the
onboard computer
Check all connectors.
Communicator does not
power up
Communicator battery is
not charged
Charge communicator unit. If
problem persists, contact your
distributor or technical support.
Communication error flashing red triangle
Communicator unit
Verify that the correct paired
Communicator unit is being used.
If problem persists, contact your
distributor or technical support.
Communicator out of
range
Test near unit
Communication error constant red triangle with
green walk mode icon
High current in one of
the
joints
User should manipulate his/her
body to release weight on the leg.
The leg will return to standing
position. If problem recurs,
increase the walk current
threshold on interface.
Communication error constant red triangle with
green manual or stand mode
icon
Global error
Verify user is in a safe position and
restart the system. If problem
persists, turn the system off and
let the user safely sit on a chair.
Contact your distributor or
technical support.
Page 49 of 66
On user interface from the Online
data tab, click "Collect Data" to
"On" and verify that the Tilt
settings update.
User Guide
Symptom
Continuous beep
‎10. Troubleshooting
Cause
Missing or discharged
battery if this occurs
during system power up.
RC displays a flashing
red battery icon.
Fix
Turn off system and replace the
battery. Restart the device. If this
fails, see technical fault below.
User did not release leg
Restart system, if this fails see
technical fault below.
Technical fault
Connect the system to the GUI, an
error message will display and a
log file sent to Technical Support
(given that there is Internet communication). System should not
be used until it is certified for safe
use by Technical Support.
System needs to be
restarted
Restart the system
(turn off and on).
USB cable
Verify cable is properly connected
or replace cable.
USB driver
Install USB driver from
installation CD.
1. Insert the CD in the CD disk
drive.
2. Open the "host_driver"
directory and double click Install.
3. Follow the instructions on the
screen.
System does not operate
after connecting to interface
System needs restart
Disconnect USB cable from
system and restart system
(turn off and on).
RC prevents the user from
selecting a new mode
The device is connected
to the PC.
Disconnect the device from the
PC.
When powering up, the
device was in an
incorrect position.
Select "Sit" mode on the RC.
Interface does not
communicate with system
Page 50 of 66
User Guide
‎11. Repair Policy
11. REPAIR POLICY
When under warranty, repair and service must be performed by Argo Medical Technologies Ltd.
When the Argo Medical Technologies warranty is not applicable, repairs may be made by Argo
Medical Technologies or an authorized representative.
For details, refer to the Warranty that is supplied with the Argo ReWalk system.
Warning: Do not remove the covers of the device components. Only perform maintenance
procedures specifically described in this User Guide.
Page 51 of 66
User Guide
‎12. Technical Specifications
12. TECHNICAL SPECIFICATIONS
12.1. CAPACITIES
Capacities
User weight
100 kg max.
User height
160 to 190 cm
Pelvic band width
29 to 37 in 2 cm increments
System weight
total: 25 kg (55 lbs)
Performance
Walking
Maximum Speed
2 km/Hr.
Joint movement
Hip
34 degrees extension; 104 degrees flexion
Knee
110 degrees flexion; 2 degrees extension
Main & Auxiliary Batteries
(Batteries have the same specifications except where noted)
Materials
Li-Ion (Main) / Li-Polymer (Auxiliary)
Voltage
25.9 V DC
Capacity
10.4 AH (2 AH for Auxiliary battery)
Working time
Minimum 3 Hr. (15 min. for Auxiliary battery)
of continuous walk
Charging temperature
0–45 degrees
Charging time
Minimum 4 hours
Power source
220 V or 110 V
Communicator
Mode
Half duplex
RF signal
2.4 GHz (ISM band)
FCC
Complies with 47 CFR Part 15
ReWalk System Charger Specifications (Main and Auxiliary / Communicator)
Input power
90-264 VAC @ 47-63 Hz / 100-240V AC @5060Hz
Max. output power for 2 channels
60 W / 8 W
Temperature range
Operating:
Storage:
Output connector
Output cable length
Safety
EMC standards
Page 52 of 66
-25 to +40°C / -40 to +70°C
-25 to +85°C / -40 to +70°C
09-0571-00-08 (Output Male connector) / R108 (Male match to PJ-041-SMT)
1.5–2 m / 1.83 m
EN60950-1,EN 60601-1,EN 60335-2-29 /
IEC60601-1, ES60601-1
EMC med. EN 60601-1-2 /Emission EN 610006-3/ Immunity EN 61000-6-1
User Guide
‎12. Technical Specifications
Environmental
Water resistant
Broad band random vibration
Environmental shock to other than handheld ME Equipment, parts and mounting
accessories
Operating range
Storage range
IP22- Per 60601-1-11, IEC:2010,
EN 60529:1991, IEC 60529:1989
6060068-2-64: 2008, IEC 60601-1-11 10.1.3c
6060068-2-27: 2008, 60601-1-11 10.1.3b
-10 degrees C to 42 degrees C
-20 degrees C to 60 degrees C
12.2. ELECTROMAGNETIC IMMUNITY
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Argo ReWalk is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should make sure that it is used in such an environment.
Immunity Test
IEC 60601Test
Compliance
Electromagnetic EnvironmentLevel
Level
Guidance
Electrostatic
±6 kV contact
±8 kV contact
The Argo ReWalk system should not
±15 kV air
discharge(ESD)IEC
±8 kV air
be affected by electrostatic discharge
(<5%
relative
61000-4-2
that might occur under normal
humidity)
conditions of use.
Electrical fast
±2 kV for power Not applicable Not applicable
transient/burst
supply lines
IEC 61000-4-4
±1 kV for
input/output
lines
Surge
±1 kV line(s) to Not applicable Not applicable
IEC 61000-4-5
line(s)
±2 kV line(s) to
earth
Page 53 of 66
‎12. Technical Specifications
User Guide
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Argo ReWalk is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should make sure that it is used in such an environment.
Voltage dips, short
<5 % UT
Not applicable Not applicable
(>95
%dip
in
interruptions and
for
0.5
cycle
voltage variations on
power supply lines
40 % UT
(60 % dip in UT)
for 5 cycles
<5 % UT
IEC 61000-4-11
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
For Charger only
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
<5 % UT
(>95 % dip in
UT)
for 5 s
3 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical public low-voltage power
supply network that supplies buildings
used for domestic purposes,
commercial or hospital, clinic
environment. Was considered also
other high levels until H=30 V/m
Recommended separation distance
R = I/2H=I/188
NOTE: UT is the AC mains voltage prior to application of the test level.
Page 54 of 66
User Guide
‎12. Technical Specifications
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Argo ReWalk is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should make sure that it is used in such an environment.
Portable and mobile RF
communications equipment should be
used no closer to any part of the Argo
ReWalk, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150kHz to 80MHz
Radiated RF
IEC 61000-4-3
3 V/m
80MHz to 2.5GHz
Not applicable
d = 1.17√P
d = 0.35√P
80 M Hz t o 800 MHz
10 V/m
d= 0.7√P
800 MHz t o 2.5 GHz
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).
Field strengths from fixed R F
transmitters, as determined by an
electromagnetic site survey a, 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:
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption, and reflection from structures, objects and people.
Page 55 of 66
User Guide
‎12. Technical Specifications
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Argo ReWalk is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should make sure that it is used in such an environment.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be
predicted theoretically with accuracy. To access 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 Argo ReWalk is used exceeds the applicable RF compliance level above, the
Argo ReWalk should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating Argo ReWalk.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
12.3. RECOMMENDED SEPARATION DISTANCES
Recommended separation distances between portable and mobile RF communications
equipment and the ReWalk system
This section provides information on the recommended separation distance between portable and
mobile RF communications equipment and Argo ReWalk. Argo ReWalk is intended for use in an
electromagnetic environment in which radiated RF disturbances are controlled. Argo ReWalk users
can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Argo ReWalk as
recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to the frequency of transmitter (m)
Rated maximum output
80MHz to 800MHz
800MHz to 2.5GHz
power of transmitter (W)
d = 0.35 √P
d = 0.70 √P
0.01
0.035
0.07
0.1
0.11
0.22
0.35
0.7
10
1.1
2.2
100
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: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Page 56 of 66
User Guide
‎12. Technical Specifications
Recommended separation distances between Power bus or an appliance wire and the ReWalk
system
Separation distance (in meters)
Rated maximum current (I) in a
power bus or an appliance wire
Amperes [A]
Meters [m]
R = I/2H=I/188
0.1
0.0005
0.005
10
0.05
100
0.53
1000
5.3
NOTE 1 The power frequency magnetic field immunity of H=30 A/m is met.
Page 57 of 66
User Guide
‎12. Technical Specifications
12.4. ELECTROMAGNETIC EMISSIONS
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Argo ReWalk is intended for use in the electromagnetic environment specified below. The
customer or the user of the Argo ReWalk system should make sure that it is used in such an
environment.
Emissions Test
Compliance
Electromagnetic Environment Guidance
RF emissions
Group 1
Argo ReWalk uses RF energy
Test: CISPR 11
only for system communication
functions. Therefore, its RF
emissions are very low and are
not likely to cause any
interference in nearby
electronic equipment.
RF emissions
Class B
Argo ReWalk is suitable for use
CISPR 11
in all establishments other than
domestic and those directly
Harmonic emissions
Not applicable
connected to the public lowIEC 61000-3-2
voltage power supply network
that supplies buildings used for
Voltage fluctuations/flicker
Not applicable
domestic purposes.
emissions
NOTE: The preceding
IEC 61000-3-3
statement is required by IEC
60601-1-2 for Group 1, Class B
devices. However, since Argo
ReWalk is battery powered, its
emissions will not be affected
by the establishment power
supply and there is no evidence
of any issues associated with
the use of the system in
domestic establishments.
12.5. RADIO FREQUENCY (RF) COMMUNICATION SPECIFICATIONS
Radio frequency (RF) communication specifications
 Communicator to INF frequency: 2.4 GHz; proprietary Argo protocol; range up to 6 feet
(1.8 meters)
Page 58 of 66
User Guide
‎12. Technical Specifications
12.6. QUALITY OF SERVICE (QOS)
Quality of service
Common consumer electronic devices that transmit in the same frequency band used by the
transmitter may prevent the INF from receiving the commands sent by the Communicator.
Adherence to the following guidelines will result in a consistent and reliable quality of service:
 Cell phone 12 inches away from Communicator and INF
 Communicator and INF within 4 feet of each other
12.7. DATA SECURITY
Data security
Argo is designed to only accept radio frequency (RF) communications from recognized and linked
devices (you must program your INF to accept information from a specific Communicator).
Argo and system components (Communicator and INF) ensure data security via proprietary means,
and ensure data integrity using error checking processes, such as cyclic redundancy checks.
12.8. COMMUNICATOR DISPLAY SIZE
Communicator display size
 Inches
o Height approximately 2.0 inches
o Width approximately 3.2 inches
o Depth (thickness) approximately 0.77 inches
 Centimeters (cm)
o Height approximately 5.1 cm
o Width approximately 8.1 cm
o Depth (thickness) approximately 2.0 cm
12.9. DAMAGE DUE TO RADIATION
Damage due to radiation
If you are going to have an X-ray, CT scan, MRI, or be exposed to other types of radiation, REMOVE
YOUR COMMUNICATOR AND BACKPACK, and leave them outside the radiation area. The Argo
ReWalk Communicator and INF are designed and tested to tolerate common electromagnetic
interference, including microwave ovens.
Page 59 of 66
User Guide
‎12. Technical Specifications
12.10. FCC COMPLIANCE
12.10.1. COMPLIANCE WITH FCC AND INTERNATIONAL STANDARDS
FCC Compliance Statement
This device has been tested and found to comply with the limits for a Class B digital device, pursuant
to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference in residential installations. This equipment generates uses and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio and television reception.
However, there is no guarantee that interference will not occur in a particular installation. If this
device does cause such interference, which can be verified by turning the device off and on, the user
is encouraged to eliminate the interference by one or more of the following measures:
– Re-orient or re-locate the receiving antenna.
– Increase the distance between the device and the receiver.
– Connect the device to an outlet on a circuit different from the one that supplies power to the
receiver.
– Consult the dealer or an experienced radio/TV technician.
WARNING! Changes or modifications to this unit not expressly approved by the party responsible
for compliance could void the user’s authority to operate the equipment.
This device complies with FCC Rules Part 15 and with Industry Canada licence-exempt RSS
standard(s). Operation is subject to two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference that may be received or that may
cause undesired operation.
Le present appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio
exempts de licence. L'exploitation est autorisee aux deux conditions suivantes :(1) l'appareil ne doit
pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage
radioelectrique subi, meme si le brouillage est susceptible d'en compromettre le fonctionnement.
12.10.2. COMPLIANCE WITH FCC SECTION 1.1310
FCC Section 1.1310 Compliance Statement
To comply with FCC Section 1.1310 for human exposure to radio frequency electromagnetic fields,
implement the following:
 A distance of at least 1 cm between the P Communicator and all persons should be
maintained during the operation of the equipment.
 A distance of at least 5 cm between the P INF and all persons should be maintained during
the operation of the equipment.
Page 60 of 66
User Guide
‎12. Technical Specifications
12.11. RF INTERFERENCE FROM OTHER DEVICES
Warning: Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
RF interference from other devices
Common consumer electronic devices that transmit in the same frequency band used by the
Communicator transmitter may prevent the INF from receiving the commands sent by the
Communicator. Most cellular (mobile) phones and 900 MHz cordless phones, when transmitting or
receiving, may cause significant interruption of Communicator – INF communication. It is likely that
other devices operating in similar frequency ranges will have a similar effect. This interference,
however, will not cause any incorrect data to be sent and will not cause any harm to your
Communicator.
Argo ReWalk includes a programmable WEAK SIGNAL alert that notifies you when one or more
expected transmissions were not received as expected by the INF. (The Communicator will also
issue a LOST SENSOR alert if communication is interrupted.)
Communication problems can usually be resolved by:
 Ensuring that there is less than 6 feet (1.8 meters) between the Communicator and INF;
 Turning off or moving away from other RF transmitting devices; or
 Reorienting or relocating the Communicator and INF, or both.
Communications problems may also occur due to cellular telephone interference. Testing
conducted with several different cellular telephones indicates that, while a command is being
transmitted, using a cell phone within 12 inches (31 cm) of receiving devices, transmitters can
interfere with reception of the transmitted values. In the event of such interference, normal
communication can be re- established by:
 Turning the cell phone off; or
 Keeping the cell phone at least 12 inches away from the Communicator or INF when an
instruction is being transmitted.
If you have questions, please contact your local representative for assistance.
This device complies with FCC Rules Part 15 and with Industry Canada licence-exempt RSS
standard(s). Operation is subject to two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference that may be received or that may
cause undesired operation.
Le present appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio
exempts de licence. L'exploitation est autorisee aux deux conditions suivantes :(1) l'appareil ne
doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage
radioelectrique subi, meme si le brouillage est susceptible d'en compromettre le fonctionnement.
Page 61 of 66
User Guide
‎13. Clinical Studies
13. CLINICAL STUDIES
Clinical Study Overview
Clinical testing consisted of a pilot study and multi-center open, non-comparative, non –randomized
studies evaluating the safety and performance of the ReWalk device. All subjects were diagnosed
with complete spinal cord injury per the American Spinal Injury Association (ASIA) guidelines. The
level of injuries ranged for T2 to L1. A total of 39 subjects were enrolled and 30 completed the study
and were considered performance-evaluable. All of the performance-evaluable subjects were able to
complete the performance outcome measures. There were no serious device related adverse events
during the course of the two studies. The adverse events reported were all skin related, such as
abrasions, which occurred in approximately 4% of the training sessions and were all resolved with
adjustments to the fit of the device.
Pilot Study Summary
Title of Study:
Performance Evaluation of ReWalk™ Reciprocating Gait Orthosis
Objectives:
Primary Objective: Establish the safety and performance of the ReWalk™ device to enable people with
lower limb disabilities to carry out routine ambulatory functions.
Secondary Objectives: Extend the safety assessment to establish the performance of the
ReWalk™ device by examining device functionality, such as device ergonomics, user friendliness,
and satisfaction.
Methodology:
An open, non-comparative, non-randomized study of the safety and performance of the ReWalk™
device.
Number of Subjects:
Enrolled: 7
Completed: 6
Diagnosis and Main Criteria of Inclusion:
Male/Female subjects of any race, ages 18-55, with chronic (at least 6 months after the injury)
complete cervical (C7-8) or thoracic (T1-T12) spinal cord injury according to American Spinal
Injury Association (ASIA) guidelines.
Duration of Treatment/Exposure:
Approximately 24, 60 – 90 minute sessions over the course of approximately 8 weeks.
Criteria for Evaluation:
“Intent-to-Evaluate” (ITE) subjects were defined as those who provided written informed consent (i.e.,
those who “enrolled”).
Performance: “Performance-Evaluable” subjects were defined as those who used the ReWalk™ device
during user training and completed the performance testing.
Safety: “Safety-Evaluable” subjects were defined as those who had any exposure to the ReWalk™
device.
Page 62 of 66
User Guide
‎13. Clinical Studies
Statistical Methods:
Investigational Product Primary Performance Endpoints: Ability of a trained subject to, at final visit,
complete:
• Six minute walk; and
• Ten meter walk.
Secondary Performance Endpoint:
• Spasticity (Ashworth Scale); and
• The device’s ability to carry a load.
Primary Safety Endpoints:
• No expected or
unexpected adverse events. Secondary
Safety Endpoints:
• Frequency of autonomic dysreflexia; and
• Multiple systems complications (e.g., skin abrasions and joint integrity).
Summary Conclusions:
PERFORMANCE RESULTS:
Primary Performance Endpoints:
• 100% of performance-evaluable subjects, who completed training, were able to
complete the six minute walk.
• 100% of performance-evaluable subjects, who completed training, were able to
complete the ten meter walk.
Secondary Performance Endpoints:
• Sixty-seven percent of performance-evaluable subjects (4/6) demonstrated no
change in Ashworth value; thirty-three percent (2/6) demonstrated a decrease in
Ashworth value.
• No device failures or malfunctions were reported in association with a subject
whose weight approached the device’s upper limit of load specification.
SAFETY RESULTS:
Primary Safety Endpoints:
• There were no expected or unexpected adverse events reported for this study.
There were no serious adverse events reported for this study.
Secondary Safety Endpoints:
• No incidents of autonomic dysreflexia were reported for any subject during this
study. Further, no incidents of autonomic dysreflexia were suggested by the
complications reported.
• No incidents of multi-system complications were reported for any subject
during this study. CONCLUSIONS:
This study demonstrates that the ReWalk™ device is safe and well-tolerated in enabling people with
lower limb disabilities to carry out routine ambulatory functions (e.g., stand and walk).
Page 63 of 66
User Guide
‎13. Clinical Studies
Multi-Center Study Summary
Title of Study:
Performance Evaluation of ReWalk™ Reciprocating Gait Orthosis
Objectives:
Primary Objective: Establish the safety and performance of the ReWalk device to enable
people with lower limb disabilities to carry out routine ambulatory functions.
Secondary Objectives: Extend the safety assessment to establish the performance of the
ReWalk device by examining device functionality, such as device ergonomics, user
friendliness, and satisfaction.
Methodology:
An open, non-comparative, non-randomized study of the safety and performance of the
ReWalk device.
Number of Subjects:
Enrolled: 32
Completed: 24
Diagnosis and Main Criteria of Inclusion:
Male/Female subjects of any race, ages 18-55, with chronic (at least 6 months after the injury) complete
cervical (C7-8) or thoracic (T1-T12) spinal cord injury according to American Spinal Injury Association
(ASIA) guidelines.
Duration of Treatment/Exposure:
Approximately 16 - 24, 60 – 90 minute sessions over the course of approximately 8 weeks.
Criteria for Evaluation:
“Intent-to-Evaluate” (ITE) subjects were defined as those who provided written informed consent
(i.e., those who “enrolled”).
Performance: “Performance-Evaluable” subjects were defined as those who used the ReWalk
device during user training and completed the performance testing.
Safety: “Safety-Evaluable” subjects were defined as those who had any exposure to the ReWalk device.
Statistical Methods:
Investigational Product Primary Performance Endpoints: Ability of a trained subject at the final visit
to complete:
• Six minute walk; and
• Ten meter walk.
Secondary Performance Endpoint:
• Spasticity (Ashworth Scale); and
• The device’s ability to carry a load.
Primary Safety Endpoints:
• The incidence of adverse events.
Secondary Safety Endpoints:
• The incidence of autonomic dysreflexia; and
• The incidence of multi-system complications (e.g., skin abrasions and joint integrity).
Page 64 of 66
User Guide
‎13. Clinical Studies
Summary Conclusions:
PERFORMANCE RESULTS:
Primary Performance Endpoints:
 100% of performance-evaluable subjects for the six minute walk (20/20), who
completed training, were able to complete the six minute walk.
 100% of performance-evaluable subjects for the ten meter walk (22/22), who
completed training, were able to complete the ten meter walk.
Secondary Performance Endpoints:
 In the performance-evaluable (for spasticity) population, as measured with average
Ashworth Scale: 8/13 demonstrated no change; 1/13 demonstrated an increase; and
4/13 demonstrated a decrease in spasticity after use of the device.
 The device is able to carry a patient load near the upper limit of the device’s load
specification.
SAFETY RESULTS:
Primary Safety Endpoints:
 The most frequent adverse events involved skin.
 All adverse events resolved uneventfully.
 No device-related or study-related serious adverse events were reported during this
study.
Secondary Safety Endpoints:
 No incidents of autonomic dysreflexia were reported for any subject during this
study.
 No incidents of autonomic dysreflexia were suggested by the complications
reported.
 Skin abrasions and related skin complications were reported in approximately 4% of
all training sessions.
CONCLUSIONS:
This study demonstrates that the ReWalk™ device is safe and well-tolerated in enabling
people with lower limb disabilities to carry out routine ambulatory functions (e.g., stand and
walk).
Conclusions:
The Pilot and Multi-center studies both support the conclusion that the ReWalk™ device is safe and
well-tolerated in enabling people with lower limb disabilities to carry out routine ambulatory
functions (e.g., stand and walk).
Page 65 of 66
User Guide
‎14. Warranty and Disclaimer
14. WARRANTY AND DISCLAIMER
Service Support
Repairs of the ARGO REWALK P System under warranty must be made by authorized repair
centers. If the device needs repair, contact Argo Medical Technologies Ltd. service
department or your local distributor for Warranty details.
If you need to ship the device, pack the device and its accessories carefully to prevent shipping
damage.
Caution: Always transport the system in the original shipping container.
Caution: Always ship the system with the batteries removed.
Page 66 of 66

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