ExoAtlet ExoAtlet-II User manual

ExoAtlet
®
-
II
User’s
Manual
이 사용설명서는 사전 통보 없이 제품의 개선을 위해 개정될 수 있습니다. 이 사용설명서의
이미지는 실제 제품과 다를 수 있습니다.

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 1 / 84 Ver 1.0 (2019.03.29.)
Contents
1. About User's Manual ················································································································ 3
1.1. General Information ······················································································································ 3
1.2. Warranty ··········································································································································· 3
1.3. Revision history ······························································································································ 3
1.4. Safety sign ······································································································································· 4
2. Safety sign ·································································································································· 5
2.1. General instructions ······················································································································ 5
2.2. General caution ······························································································································ 6
2.3. General warning ····························································································································· 8
2.4. General prohibition ······················································································································· 9
3. Main functions and appearance, specifications ······························································ 10
3.1. Intended Use ································································································································ 10
3.2. Working principle ························································································································ 10
3.3. Intended patient population and use environment ··························································· 11
3.4. Eligibility ········································································································································· 11
3.5. Frequently used functions ········································································································· 12
3.6. Specifications ································································································································ 15
3.7. Applied safety standards ··········································································································· 17
3.8. Appearance and function ·········································································································· 18
3.9. Operating Environment ·············································································································· 21
3.10. Storage Environment ················································································································ 21
3.11. Transportation condition ········································································································· 21
3.12. Symbol (Include safety sign) ·································································································· 22
3.13. Label ············································································································································· 25
4. Size adjustment ······················································································································· 26
4.1. Shoe insole/Shoe sole ················································································································ 26
4.2. Calf length adjustment ·············································································································· 27
4.3. Calf depth adjustment ··············································································································· 27
4.4. Thigh length adjustment ··········································································································· 28
4.5. Thigh depth adjustment ············································································································ 28
4.6. Pelvic floor depth control ········································································································· 29
4.7. Adjust pelvic floor area ············································································································· 29
4.8. Hip Abduction / Adduction ······································································································ 30
4.9. Ankle joint angle adjustment ··································································································· 31

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 2 / 84 Ver 1.0 (2019.03.29.)
4.10. Height adjustment of back ·································································································· 31
5. Wearing ······································································································································ 33
5.1. Precautions before wearing ······································································································ 33
5.2. Clothes recommendation ··········································································································· 33
5.3. Getting ready ································································································································ 33
5.4. Transferring to exoskeleton ······································································································ 34
5.5. Putting on exoskeleton ·············································································································· 36
6. Operation ··································································································································· 39
6.1. Preparation before use ·············································································································· 39
6.2. General functions ························································································································ 39
6.3. Emergency Stop Function ········································································································· 40
6.4. How to clean and store after use ························································································· 41
7. Tablet PC operating ··············································································································· 42
7.1. Starting ··········································································································································· 42
7.2. Trainings ········································································································································· 44
7.3. Service ············································································································································ 65
7.4. Settings ·········································································································································· 66
7.5. About ·············································································································································· 67
7.6. Exit ··················································································································································· 67
8. ExoCrutch operation ··············································································································· 68
8.1. ExoCrutch structure ····················································································································· 68
8.2. ExoCrutch available motions: ··································································································· 69
8.3. ExoCrutch operation ··················································································································· 70
8.4. ExoCrutch operation ··················································································································· 71
8.5. Error reset ····································································································································· 73
9. Charging the battery ·············································································································· 74
9.1. Charging exoskeleton ················································································································· 74
9.2. Charging Tablet PC ····················································································································· 75
9.3. Charging ExoCrutch ···················································································································· 76
10. Trouble Shooting ·························································································································· 77
11. Maintenance ··························································································································· 78
11.1. Maintenance ······························································································································· 78
11.2. Disposal of equipment ············································································································ 78
12. Appendix ································································································································· 79
12.1. Product quality assurance policy ·························································································· 79
12.2. Instructions and manufacturer declarations ······································································· 80

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 3 / 84 Ver 1.0 (2019.03.29.)
1. About User's Manual
1.1. General Information
This document contains proprietary information protected by copyright.
This user manual is provided with the Powered Lower Extremity Exoskeleton
(ExoAtlet®-II).
This user's guide explains how to use and precautions, and explains the possible
hazards that you should be aware of and be aware of while using the Powered
Lower Extremity Exoskeleton (ExoAtlet®-II).
If you have any questions about the product or need more information about
the product, please contact the Customer Service Center using the contact
information.
1.2. Warranty
The contents of this document are subject to change without notice.
The manufacturer is not responsible for any resulting problems, losses, or
damages that result from the use of other performance specifications or other
information other than those contained in this manual.
1.3. Revision history
The document and revision numbers shown in this document represent the
current version.
When there is a significant change in the document number or the technical
content of the document, the version number may change.

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 4 / 84 Ver 1.0 (2019.03.29.)
1.4. Safety sign
Symbols for safety signs are shown on the enclosure, on the packaging of the
product and in this manual.
Symbols provide users with important information such as caution, warning, and
prohibition. Carefully read the symbols shown below and make good use of this
information for product use and storage.
Caution
Caution
This safety sign means caution. This indicates a potentially
hazardous situation which, if not avoided, could result in minor
injury. It can also be used to warn of unsafe use or potential
damage to equipment.
Warning
Warning
These safety signs indicate warnings. This indicates a potentially
hazardous situation which, if not avoided, could result in serious
injury, including death or serious injury.
Notice This safety label indicates mandatory action. This means that the
user or patient must follow mandatory instructions.
prohibition This safety label indicates general prohibitions. This is a
mandatory requirement that you or your patient must obey.
* When it is deemed necessary, the manufacturer is not obligated to apply the same
specification changes as those already sold in relation to the improvement to improve
the performance of the product.

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 5 / 84 Ver 1.0 (2019.03.29.)
2. Safety sign
2.1. General instructions
Notice
1
Pilot recommended requirements
- Use for patients over 18 years old.
- Please use it for the use of patient whose height is 160 cm ~ 190 cm.
- Please use it for patients weighing less than 100 kg.
2
Pilot Dress Recommendations
- It is recommended to use sneakers with straps or Velcro.
- Put on comfortable clothes that fit well.
- When using an insole, the pilot must use a pair of 1-2 cm size (10-15 mm)
shoes that is larger than the pilot's shoe size. We recommend shoes with
removable insole.
- Do not wear boots or shoes with heels.
- It is recommended to use gloves for weight training or cycling.
- We recommend using an armband to prevent wrist injuries.
# "Pilot" means the user(patient) wearing an exoskeleton.

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 6 / 84 Ver 1.0 (2019.03.29.)
2.2. General caution
Caution
Precautions before use
1 If you use this unit, be sure to read and understand the instruction manual.
2
Make
sure
that
the
power
of
the
main
unit
and
the
tablet
PC
are
charged
and that the dedicated software of the product is installed and operating
properly on the tablet PC.
3 Please use under the prescription and guidance of a specialist.
4 It is recommended to use in an independent space where it is not distracting.
5 Before using this unit, please use it in a psychologically stable condition.
6Make sure that the battery of all devices (body, smart crutches, tablet PC) is
fully charged.
7
Arbitrary disassembly and replacement of internal parts is not permitted. All
information regarding the repair and replacement of the equipment shall be
provided to our A / S team and carried out by our designated personnel.
8
Use
accessories,
adapters,
and
cables
that
are
not
provided
by
our
company,
which may increase the electromagnetic radiation or reduce the
electromagnetic immunity of this unit, so please be sure to connect the
components supplied by us. .
9When not using the product, turn off the power and store it in an
environment suitable for the storage environment.
10
Other devices may malfunction due to the electromagnetic interference
generated by this unit. In addition, this unit may malfunction due to
electromagnetic interference from other equipment (equipment that emits RF
energy such as an electric cauter or electrosurgical instrument). Do not use it
near other devices.
11
This device is a body wearable medical device that can be worn on the body.
When transporting, please put it in designated storage box and carry it with
care. Failure to do so may result in damage or malfunction of the unit.
12
Do
not
disassemble
or
repair
or
modify
it.
Only
qualified
technicians
can
inspect and repair the product. If the product is disassembled at will, the
service will not be available within the warranty period. If technical Support
necessary, contact your nearest customer support center.

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 7 / 84 Ver 1.0 (2019.03.29.)
Caution
Precautions when using
1 Use the exoskeleton on a flat surface.
2 Do not tap or touch the moving parts of the exoskeleton during operation.
3 Do not use the equipment if the parts are damaged.
4
Be
careful
not
to
let
water
or
foreign
matter
come
into
the
exoskeleton
or
into the inside of the exoskeleton .
5
Avoid
places
with
high
temperature,
dust,
and
salt,
and
use
in
a
well
ventilated place.
Caution
Storage Precautions
1
Do
not
expose
the
unit
to
direct
sunlight,
heat
sources,
water,
high
humidity,
or mechanical shocks. Please keep in the storage environment conditions
specified in this document.
2Do not store it in a place where water or foreign matter can enter the
equipment when storing it.
3Do not subject the product to strong impacts such as falling over or stepping
on the product. It may cause malfunction.
Caution
Charging Precautions
1
You must connect the appropriate power source to charge the device. Do not
disassemble the unit for service or repair while in use. For safe use, the Tablet
PC and Adapter must be periodically inspected and replaced in case of failure.
2Be careful not to touch the equipment or the cord with liquid such as water.
It may cause electric shock.
3Be careful not to damage the power cord and the cables of the adapter. If it
is damaged, remove the cord immediately and ask the seller for repair.
4Do not wrap or cover the product with a fabric such as a blanket, cloth, or
cloth during charging. It may cause fire.

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 8 / 84 Ver 1.0 (2019.03.29.)
2.3. General warning
Warning
Warning
1
If any abnormality is found in the device or patient, stop operation
immediately, take the patient to a safe condition and consult the
manufacturer or specialist.
2Depending on the patient's pelvis, thigh, calf, and foot size, adjust the
exoskeleton area to suit.
3 After using the exoskeleton, check the patient's body for scratches or injury.
4All movements of the exoskeleton begin after three beeps. When the beep
sounds, the pilot must be ready to move.
5 Do not wear the exoskeleton too tightly.
6 Do not use hard objects in your pocket.
7Do not store any part of the equipment in places that are too cold (-20 ° C
or less).
8When connecting or disconnecting power to the unit, do not combine or
remove it with wet hands.
9Do not use the product for any purpose other than its intended use. Misuse
can cause injury to the pilot (or patient).
10
Do
not
use
liquids
or
detergents
directly
on
the
exoskeleton
when
cleaning
the machine.
(Clean according to the specified cleaning and storage methods.)
11
The
battery
requires
regular
inspection
or
replacement,
and
if
the
ME
equipment is not used for a certain period of time, it is requested by the
manufacturer to remove the battery or to be inspected by the manufacturer
prior to re-use.

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 9 / 84 Ver 1.0 (2019.03.29.)
2.4. General prohibition
prohibition
1Do not use patients who can not normally communicate with their doctor or
physical therapist due to cognitive and language disorders.
2
Do not use a patient with a muscle contracture in the hip, knee or ankle, or
a patient with severe muscle cramps in the leg (Modified Ashworth Scale
Grade 3 or higher).
3 Do not use a patient with low bone density or osteoporosis [BMD (t≥ -3.5)].
4Do not use in patients with fractures or incomplete bone joints in the spine,
pelvis and lower extremities.
5Do not use in patients with severe arthritis, acute arthritis or synovitis after
total or partial lower extremity joint formation.
6Do not use in patients with dermatological conditions such as hip, leg, etc.,
where fixing devices are worn.
7Do not use patients with orthostatic hypotension, essential hypertension, or
conditions in which blood pressure can not be controlled.
8Do not use in patients with myocardial infarction, angina, or ischemic heart
disease within the last 6 months.
9Do not use tachycardia, bradycardia, arrhythmia, or other patients with
uncontrolled cardiac function.
10 Do not use for patients whose diabetes is not controlled.
11 Do not use in patients with infectious diseases or other serious complications.
12 Do not use patients with paralyzed whole bodies.
# If you have other injuries or illnesses, please consult your doctor before using the
device.

User’s Manual http://www.exoatletasia.com
ExoAtletⓇ II 10 / 84 Ver 1.0 (2019.03.29.)
3. Main functions and appearance, specifications
3.1. Intended Use
The ExoAtlet®-II is a gait training device that improves gait performance of
patients with neurological or muscular injury, disease or disability, rebuilds
muscles, and restores joint motion.
The ExoAtlet®-II is a battery-powered, bionic, lower-limb orthosis system
designed to assist a patient with a walking disability (neurogenic, muscular, or
osseous in origin) regain lost motor function by manipulating the legs through a
normal walking pattern during ambulation including stand, walk, ascend and
descend stairs. The system includes an exoskeleton structure made of metal with
electric motors, mechanical actuators, an on-board computer, controls; it is
typically strapped to the patient over clothing. The ExoAtlet®-II is intended for
multiple-patient use, typically in a controlled clinical setting (e.g., gait lab,
rehabilitation centre) under professional supervision.
3.2. Operating principle
Normal gait movements rely on the functional integrity and interactions of
sensory neural networks at the spinal and vertebral levels. This complex system
can be hampered by a number of neurological conditions, such as stroke or
spinal cord injury (SCI), in limited mobility or gait, which is a major challenge in
nerve rehabilitation. Intensive, iterative task-based training can lead to beneficial
nerve regeneration, improve functional recovery, and improve end results.
Treadmill training and gait machine training, which partially support weight or
not support, have been used to improve walking after SCI and SCI, among
which repetitive walking exercises and more active involvement of pilots An
exoskeleton gait training device is designed to allow induction, voluntary,
autonomous motion modes and various training programs.
This product is designed for walking (walking) with deceleration (flexion) and
increase (extension) extension of the angle between the two joints of the Knee
joint around the hip joint of the human body Training equipment. It consists of
a control box that controls the physical energy by controlling the electric left
and right gait joints, a smart control device for start / stop control, a built-in
rechargeable battery, and crutches, etc..

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3.3. Intended patient population and use environment
Powered Lower Extremity Exoskeleton (ExoAtlet®-II) is designed for adults 18
years and older who have no mental disability and can read and understand the
characters on the display screen. They can be used by a clinic or hospital under
the prescription and guidance of a specialist.
This product is not intended for use as a rehabilitation device. The pilot is for a
group of patients with at least 4/5 (Harrison) upper limb movement in both
arms and is performing a walking exercise at the rehabilitation center under the
supervision of a trained physical therapist.
It is used to improve the gait function of patients with neurological or muscular
injuries, diseases or disabilities, to rebuild muscles, and to restore joint motion.
3.4. Eligibility
This product may only be handled by a professional trainee (such as a physical
therapist) or an expert assigned to the task. The user of the product must
observe the following when handling.
3.4.1. You must be a certified professional (physiotherapist, doctor, etc.) who can read,
understand, and perform the user's manual.
3.4.2. Be familiar with the basic structure and functions of the product.
3.4.3. You should be able to detect abnormal behavior and take action if necessary.

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3.5. Frequently used functions
Primary function SECONDARY FUNCTION
Exoskeleton:
- Execution of the
rehabilitation exercises
Back:
- Mechanical connection of the right and left femoral drive.
- Fastening of the spine-sacral corset.
- Fastening of shoulder straps.
- Battery placement.
- Location of the central microcontroller. Location of the
central computer module
- Placement of handles to insure the patient with an
accompanying person (assistent).
- Placing control buttons exoskeleton, incl. emergency stop
buttons.
- Placement of indicators of the state of the exoskeleton.
- Adjusting the height of the straps.
- Adjust the width of the pelvis.
- Adjustment of the angle of lead / hip reduction.
- Supporting element.
Thigh:
- Mechanical connection with back and shin.
- Flexion / extension of the legs of the patient in the knee
and hip joints
- Adjust the length of the thigh of the exoskeleton.
- Fixation of the thigh bindings.
- Adjustment of the position of the femoral mounts along
the sagittal axis (forward-backward).
- Mounting the sciatic harness.
- Supporting element.
Shin:
- Mechanical hip joint and exoskeleton foot.
- Adjustment of the length of the shin of the exoskeleton.
- Fixation the shin bindings.
- Adjustment of the position of the shin bindings along the
sagittal axis (forward-backward).
- Adjustment of the position of the shin bindings along the
front axis to the left and to the right).
- Providing a hinged connection with a stack of exoskeleton
with adjustable elasticity.
- Supporting element.
Foot:

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Primary function SECONDARY FUNCTION
-
Mechanical
connection
with
the
exoskeleton
shin.
- Fastening the patient's foot (together with shoes).
- Support function.
Central computer module software:
- Monitoring the state of all electronic modules;
- Database management;
- Setup trajectories for drives;
- Update firmware of all electronic modules;
Calculation of statistical information about the current
training;
- Connection with exoskeleton control modules via Bluetooth;
- Web-interface for configuring the settings of all exoskeleton
modules, displaying the status of modules, connecting new
Bluetooth control modules, downloading firmware, a
command for service launch of the exoskeleton.
Central microcontroller software:
- Integrity control of the onboard computer network;
- Control of the state of all electronic modules;
- Accept and processing commands to control the movement
of the exoskeleton from the central cleaning module;
- Generation of control signals for engine control modules;
- Control of the means of light and sound indication of the
skeleton;
- Processing of button presses exoskeleton.
Engine control module software:
- Receiving data for controlling the drive motor from the bus
interface from the central microcontroller;
- Drive motor control;
- Functions of drive control electronics self-testing;
- Indication of module operation;
- Update firmware to a new one, received from the central
device.
Set
of
the
belts:
- Fixation of the patient
in the exoskeleton.
Thigh
fixing
kit:
- Fixation of the patient's thigh.
- Adjustment to the patient's thigh.
Shin fixing:
- Adjustment to the patient's shin..
Lumbosacral corset:
- Fixation of the lumbosacral region of the patient.

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Primary function SECONDARY FUNCTION
-
Adjustable
to
the
waist
circumference
of
the
patient.
- Adjusting the depth of the pelvis (due to replaceable liners)
Shoulder straps:
- Fixation of the thoracic part of the patient.
- Adjustment for different patient growth
Sciatic band:
- Holding the torso from falling through with a sciatic strap
while standing up.
Set of insoles:
- Function of the support surface for the patient's foot.
- Adjusting the size of the foot
“Smart”
crutch:
- support
- remote control
Crutch:
- Support function for maintaining balance
Remote Control:
- Management of exoskeleton
- System status indication
“Smart” crutch software:
- Connect to the exoskeleton via the Bluetooth module;
- Receive and display information about the state of the
skeleton, the level of battery power and supported models
of traffic;
- Giving the user the ability to select by the control buttons
the necessary motion model and send an exoskeleton
command to launch the desired motion model.
Tablet
PC:
- Display of information
on last training
- Exoskeleton
management, execution
training
- System status indication
- Software update via
Web-based interface
Android
app:
Bluetooth connection to the exoskeleton;
Obtaining information about the state of the exoskeleton,
the level of charge of its batteries;
Receiving and displaying the training base on the
exoskeleton; establishment of new training; an integer for
changing the exoskeleton poses, triggering and motion
remains.

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3.6. Specifications
Product name Powered Lower Extremity Exoskeleton
Model
name
/
Type
Ref. ExoAtlet®-II / EA2010
Protection
against
electric shock INTERNALLY POWERED, B type applied part
Applied parts Corset and strap for fixing the body
Device classification
Class
IIa
(According to council Directive 93/42/EEC AnnexⅨ Rule 9)
Packing unit 1 set
Expected Life Time 5 years
Rated Power
1.
Main
Body
- Charger Input: 100-240 V~, 50-60 Hz, 3 A
- Input Power: 29.4 V-, max. 7.0 A
- Rechargeable batteries: 25.55 V-, 5700 mAh x 2PCs
2. Remote control crutch
- Charger Input: 100-240 V~, 50-60 Hz, 0.2 A
- Input Power: 5.0 V-, max. 1.0 A
- Rechargeable battery: 3.63 V , 2600 mAh
Communications Bluetooth Ver. 4.0, Wifi Ver. 802.11 b/g/n
Dimensions of outer
shape
1.
Main
body:
43~80
cm(W)
x
27~50
cm(D)
x
110~160
cm(H)
2. Crutch Size: 74 ~ 94 cm
Weight Main Body: Appr. 25 kg, Crutch: Appr. 615 g
Classification
of
installation and use Body-Worn(신체착용형)
Maximum
continuous
operating time < 4 hour
Charging time < 4 hour(At 100% full charge.)
Exercise range
specification
1.
Hip
joint
- Flexion 108°, Extension 21°
- Adjustment of abduction angle 0°-3°
- Adjustment of adduction angle 0°-4°
2. Knee joint
- Flexion 112°, Extension 2°
3. Ankle joint
- Plantar flexion 25°

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-
Dorsiflexion
15°
- Adjustment of eversion angle 0°-5°
- Adjustment of dorsiflexion limit 0°-15°
Tablet PC requirements
Mobile software is compatible with tablet PC that meet the
following specifications.
- Operating system: Android v5.1 (Lollipop) or higher
- CPU: Quad core, 1.5 Ghz or higher
- RAM / Internal memory: 1.5 GB / 16 GB or higher
- Display resolution: 1280 x 800 (16:10)
- Blue-tooth version: v4.0
- Wifi version: 802.11 b/g/n
- Adaptor set: Certified EN/IEC 60950-1

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3.7. Applied safety standards
IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
IEC 60601-1-2:2014
Medical
electrical
equipment
-
Part
1-2:
General
requirements
for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and
tests
IEC 60601-1-6:2016 Medical electrical equipment – Part 1-6: General requirements
for safety – Collateral standard :
IEC 62304:2008
EN 62304:2006/AC:2008 Medical device software - Software life-cycle processes
IEC
62366:2007
EN 62366:2008
Medical
devices
-
Application
of
usability
engineering
to
medical devices
EN ISO 15223-1:2016
Medical
devices
-
Symbols
to
be
used
with
medical
device
labels, labelling and information to be supplied - Part 1:
General requirements
EN 50581:2012
Technical
documentation
for
the
assessment
of
electrical
and
electronic products with respect to the restriction of
hazardous substances
IEC 62321:2008
Electrotechnical
products
-
Determination
of
levels
of
six
regulated substances (lead, mercury, cadmium, hexavalent
chromium, polybrominated biphenyls, polybrominated
diphenyl ethers)

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3.8. Appearance and function
3.8.1. Main Body
No.
Name
Function
1
Emergency
stop
button
In
the
event
of
an
emergency,
the
button
can
be
used
to
stop the operation of the device.
2 Handle
It
is
a
handle
that
an
assistant
can
hold
when
supporting
the product.
3
Thigh
fastener.
It
is
a
device
that
can
fix
the
user's
thighs.
4
Shank
binding.
It
is
a
device
that
can
fix
the
user's
calf.
5 Insole
Secure
the
shoes
with
the
sole
that
is
adjusted
to
fit
the
foot size of the pilot.
6 Stop button
When
the
button
is
pressed
during
operation
with
the
button for temporarily stopping the operation of the
machine, the machine stops in the state where both feet
are standing upright.
7 Shoulder straps
It
is
worn
on
the
shoulder
with
a
strap
that
can
fix
the
user's upper body.
8 Corset
It
is
worn
on
the
body
as
a
belt
that
can
fix
the
body
of
the user.
9 Cam levers
Adjust
the
thigh,
calf
and
pelvic
size
to
the
correct
position for your body and turn the lever to fix it.

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3.8.2. Remote control crutch
: A left / right 1 set is provided as a crutch for supporting the patient's body.
➐➏
No. Name Function
1 display
A
screen
to
check
the
mode
or
connection
status
of
the
product.
2
Run
/
Stop
button(Left
button)
Button used to instruct the operation of the product or to
stop the device in operation.
3
Mode
change
button
(Right button)
Button to select the operation of the product.
4 Power button Button to turn on / off the product power.
5 Charge connector Port used to charge the product.
6 handle A handle that can be held by the user.
7 support fixture Supports to support the user's load or adjust the length.