TREXO Plus User manual

Trexo Plus User Manual
QMS-USR-753.006 Rev 1- Trexo Plus Manual

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Table of Contents
Important Safety Instructions 4
Introduction 6
Recommended use 7
Device specification 8
What comes with the Trexo device 9
Familiarize yourself with the Trexo robotic legs 10
Familiarize yourself with the Rifton Dynamic Pacer 11
1. Trexo app
Trexo interface – connect your Trexo Home to wi-fi 12
Trexo interface – user profile & activity information 13
Trexo interface – user session 17
Trexo joint LED guide 18
Trexo interface – setting and modifying gait 19
Trexo interface – settings 20
Trexo interface – user information 21
2. Device use
Starting the Trexo Home device 22
Setting the Trexo leg lengths 23
Running a session 24
Readjusting device height 26
Resetting the gait pattern 28
Conducting an inspection check 30
Turning 31
3. Features 
Trexo battery box LED guide 32
Warranty 33
Response procedures for faults 34
Maintenance & cleaning instructions 36
Charging Best Practices 37
Assistance information 38
QMS-USR-753.006 Rev 1 - Trexo Plus Manual

Important Safety Instructions
ALL OPERATORS OF THE TREXO PLUS DEVICE MUST UNDERSTAND THAT
POTENTIALLY SEVERE INJURY MAY OCCUR FROM MISUSE. TREXO ROBOTICS
INC. IS NOT RESPONSIBLE FOR ANY INJURY, LOSS, OR DAMAGE THAT OCCURS IN
CONNECTION WITH YOUR USE OF THE DEVICE.
Please read this entire user manual carefully before you use the device and keep the
manual for future reference. Additional copies are available on request.
BASIC TERMINOLOGY
The Trexo Device - Your Trexo robot attached to the Rifton Dynamic Pacer
The Trexo User - The individual using the Trexo device
The Trexo Trained Supervisor - The individual who are trained and certified by the
Trexo Robotics Customer Success team, to operate the Trexo device for Trexo users
WARNING – To reduce the risk of fire, electric shock, or injury to persons:
•Treat the Trexo Device with care. Do not drop it or expose it to any heavy shocks.
•Do not operate the device if the power supply battery, power and control cables, or
the device itself have been damaged in any way, there is liquid spilling out, or objects
have fallen into the device.
•In the case that the device has been dropped or damaged, start the device and run it
without a Trexo User. Discontinue use of the Trexo Device if it does not operate
normally and inform the Trexo Robotics Customer Success team using the Trexo
Chat App.
•Do not use the device if any separate Trexo Device components or the device in its
entirety have been exposed to rain or moisture and it does not operate normally.
•Do not use the Trexo Device in wet surroundings (e.g. in the rain, near a swimming
pool, by the lake) as battery exposure to water can be dangerous.
•Do not immerse any Trexo Device components, including the robotic leg
attachments, battery and cables in water or rinse under the tap. Refer to cleaning
instructions (page 38) on how to care for your device properly
•Do not use the Trexo Device if there is visible damage, broken components, or
missing parts.
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Important Safety Instructions
Please read this entire user manual carefully before you use the device and keep the
manual for future reference. Additional copies are available on request.
WARNING – To reduce the risk of fire, electric shock, or injury to persons (continued)
:
•Do not operate the Trexo Device if the power supply battery, power and control
cables, or the device itself have been damaged in any way, there is liquid spilling
out, or objects have fallen into the device.
•Only use the original battery and chargers provided. If either component is
damaged, contact Trexo Robotics at the Trexo Chat app for assistance.
•Check that the voltage indicated on the charger corresponds to your power
outlet voltage before you charge the Trexo Device.
•Do not use or run the Trexo Device while the charger is plugged into the device.
•Make sure the cables remain unobstructed during the use of the device. Protect
all cables from being pinched, particularly the plugs at the outlet and cables
where they exit the joints.
•Do not expose the device to rain or liquid spills.
•In the event the Trexo User is caught in the rain, the Trexo Trained Supervisor
must turn off the device immediately, and seek shelter. Once in shelter, do not
turn on the device or charge the device. Inform the Trexo Robotics team that the
Trexo Device has sustained water damage.
•Do not store the device outdoors
•If experiencing any interference or difficulty operating another device in the
vicinity of a Trexo device, move away and/or turn off the Trexo device.
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CAUTION - To ensure the Trexo device is used correctly and safely:
•The Trexo Device must be used under the supervision of a Trexo Trained
Supervisor.
•Trexo Users must be within 3 meters of a Trexo Trained Supervisor at all times. The
Trexo User must never be left unattended in the Trexo Device. Trexo Users left
unattended and unsupervised in the Trexo Device may be liable to injury.
•All new operators must be trained by a member of the Trexo Robotics Customer
Success team. The Trexo Device must never be operated by individuals who have
not been certified by the Trexo Robotics Customer Success team to operate the
device.
•The Trexo Device is not capable of turning by itself and requires assistance from
the Trexo Trained Supervisor.
•Use the device on stable, even, and non-slippery surfaces without any obstacles in
the way. Do not use the device on grassy surfaces, carpeted surfaces, muddy
surfaces, rocky surfaces, hilly surfaces and/or other similar terrains.
•All four Rifton wheels must be firmly planted on solid ground at all times. The locks
on the wheels must be unlocked with the wheels in a non-ratcheting position.
•Do not use the Trexo Device in areas which could lead to injury or harm, including
near stairwells and inclined or elevated surfaces.
•Do not attach the Trexo Robotic legs to other pacers, gait-trainers, or walkers. The
Trexo Device is only meant to be used with the provided Rifton Dynamic Pacer Gait
Trainer.
•The Trexo User must be using the Rifton Chest prompt anytime they are using the
device.
•The Trexo Device is not meant to be used for extensive periods of time. The Trexo
Device must only be used to a maximum of 2 times daily for 1 hour per session.
•The Trexo Device can be used with an Trexo Certified Treadmill (Optional)
•The Trexo Device must never be used in conjunction with any treadmills or similar
equipment other than the Trexo Certified Treadmill created by the Trexo Robotics
team. Using a non-Trexo Certified Treadmill may result in serious injury.
•Trexo Trained Supervisors must be familiar with the Trexo User’s displays of pain,
discomfort, fatigue and any signs of distress so when they display it, the Trexo
Trained Supervisor must stop the device.
Important Safety Instructions
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CAUTION - To ensure the Trexo device is used correctly and safely:
•All Trexo Users must be consulted by a Physical Therapist or Physician prior to
their Trexo Use
•In the event the Trexo User is in any significant pain, discomfort, or is displaying a
high degree of spasticity, the Trexo Trained Supervisor must stop the device
immediately and discontinue use.
•The Trexo Trained Supervisor must discontinue use if the Trexo User experiences
any allergic reaction, skin irritation, abrasions, or burns at any points of contact
with the Trexo Device.
•The Trexo Trained Supervisor is responsible for ensuring the Trexo User is using the
Trexo Device in a safe environment at all times.
•Trexo Users with any open abrasions, or wounds should not use the Trexo Device to
minimise the chance of further infection or injury and/or cross-infection with
another Trexo User.
•To prevent infection, the Trexo Device must be cleaned using alcohol based wipes
prior to each session.
•The Trexo User must wear long trousers which cover the user’s knees when using
the Trexo Device to avoid friction burns and minimize the effects of hot surfaces.
•The Trexo User must wear shoes and/or AFOs to prevent injury or harm to the
User’s feet.
•The Trexo Device will perform when operating between 5° C - 35° C degrees (41° F
- 95° F).
•The Trexo Device has an emergency stop for use in the event of a dangerous
situation. The Trexo Trained supervisor must be within reach to stop it at all times.
•The Trexo User must be removed and strapped into the Trexo Device correctly
based on the training provided by the Trexo Robotics Customer Success team.
•The Trexo User must be reassessed by their Primary Care Physician and Physical
Therapist on an annual basis to ensure that the Trexo Device is appropriate for
usage.
Important Safety Instructions
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Introduction
Welcome to the Trexo Plus family!
About the Trexo Plus
The Trexo Plus is a wearable lower limb robotic device that is attached to a Rifton
Dynamic Pacer Gait Trainer. It utilizes principles of powered lower limb robotics to
enhance gait training and locomotion training. Motors power the device joints at the
hip and knee while motion is controlled through a tablet interface operated by a
Trexo trained individual.
Trexo Robotics does not claim/guarantee clinical benefits. Results may vary.
For more information about the Trexo Plus, visit us at www.trexorobotics.com.
Audience
This manual is intended to be read and used as a reference by care providers and/or
individuals who have received training in the correct use of the Trexo Plus. The
trained individual is responsible for the correct operation of the Trexo device.
FDA Information
The Trexo Plus is a Class II medical device.
Health Canada Information
The Trexo Plus is a Class I medical device.
Trexo Device Weight Restrictions
The Trexo Device weight restrictions exist for the safety of the Trexo User. Please
ensure the Trexo User is using the correct size Trexo Device for their weight.
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Trexo Device Sizes
Small/Medium Large X-Large
Weight (lbs) 80 125 150
Weight (kg) 36.3 56.7 68
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Recommended Use
The Trexo Device enables children to receive gait training using robot-assisted
technology in a mobile and stable manner. The Trexo Device is intended to be used as
an exercise tool, operated under close supervision by a Trexo Trained Supervisor.
The Rifton frame should be fitted to the child’s height and the Trexo legs should be
fitted to the child’s thigh and shin length. Please ensure you are using the correct
height device. User height requirements can be found on page 10 (next page) of this
manual.
Any individuals exhibiting the following, may not be candidates for the Trexo Device:
❑Knee flexion contracture > 20°
❑Knee valgus > 40°
❑Hip subluxation > 40% migration percentage with pain during walking
❑Hip subluxation > 50% migration percentage unless with orthopedic clearance
for weight bearing with the Trexo
❑Hip extension < -10°
❑Spasticity, resistance, or behavioural concerns that interfere with the use of the
device may limit use
❑Weight bearing restrictions (including from any recent Orthopaedic surgery,
e.g. soft tissue releases and lower limb bony surgery)
❑Moderate to severe Osteogenesis Imperfecta
Trexo Device Users should be monitored by their physical therapist and cleared for
Trexo Device use annually.
Facilities with more than one Trexo Device should configure their tablet to only
remember one device's network, and each tablet should be labelled with device serial
number.
May contain contraindications for users and each user needs to get contraindications
reviewed by their physician every year.
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Device specifications
Technical specs
Small/Medium Large X-Large
Dimensions of device
(cm) 76 x 66 91 x 71 101 x 80
Height of device (cm) 55 - 69 72 - 98 79 - 104
Weight of device (kg) 43 45 47
Minimum Maximum
Speed 10 steps/min 70 steps/min
Extension Flexion
Hip joints 30° 50°
Knee joints 0° 90°
User Sizes (cm) Small Medium Large X-Large
Min Max Min Max Min Max Min Max
Hip to floor 40 47 43 53 29 76 62 94
Hip to knee 18 18 21 24 26 34 29 39
Knee to floor 22 29 22 29 29 42 33 55
Hip width 20 33 20 33 20 35 22 41
Thigh girth 20 38 20 50 20 70 20 70
Shin girth 12 30 12 38 12 50 12 50
Weight (kg) 0 36 0 36 0 56 0 68
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What comes with the Trexo device
The Trexo Plus comes fully equipped with everything required for operation. Trexo
Plus is designed to work with a Rifton Pacer Gait Trainer K630 or K640 or K650
(included) for which additional accessories may be purchased separately.
A fully assembled and ready for use Trexo Plus is displayed in the image
above.
The device consists of the following parts:
1. Two robotic legs
2. Set of straps for calves and thighs (large only)
3. Ankle joints of different sizes
4. Emergency stop button
5. Battery, Wi-Fi transceiver & Charger
6. Tablet with preinstalled Trexo app
7. Rifton Pacer Gait Trainer (K630 or K640 or K650) with saddle and
select accessories
8. Maintenance kit
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Robotic leg components
Your Trexo device comes equipped
with two robotic legs which can be
attached to the Rifton walker.
Each leg consists of several parts
displayed in the figure to the left.
The components are as follows:
1. Powered hip joint
2. Cable receptible to connect battery
3. Straps
a) Thigh strap (removable)
b) Calf strap (removable)
4. Strap cuff fasteners
5. Powered knee joint
6. Ankle joint (removable)
7. Ankle strap
8. Height adjustment clamps
a) Thigh clamp
b) Shin clamp
9. Power and control cable
10. Leg attachment slider
11. Rifton leg width adjustment knob
12. Rifton post
Inspect the Trexo legs each time you
use the device for any visible damage.
If you find any components that are
missing or are damaged, do not
proceed with the use of the device.
*Shoes are not included. Pictured for
display purposes.
Familiarize yourself with the Trexo robotic legs
1
4
5
8a
10
2
3a
3b
9
7
11
6
8b
12
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This guide is for quick reference on Rifton
features. For full user guide and
instructions on using your Rifton, please
refer to the manual encloser with the
Rifton Dynamic Pacer.
The components are as follows:
1. Dynamic upper frame
2. Standard base
3. Swivel wheel
4. Swivel release
Familiarize yourself with the Rifton Dynamic Pacer
1
8
23
54
6
7
9
10
11
13
12
14
5. Swivel lock
6. Brake
7. Direction lock
8. Multi-position saddle
9. Seat location adjustment
10. Saddle tilt adjustment
11. Saddle height adjustment
12. Side-to-side movement lock
13. Dynamic movement lock
14. Frame height adjustment
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Connect your Trexo Plus to Wi-Fi
Select “Internet Settings” in your login
screen.
1
The tablet should auto-connect to the Wi-Fi network called “Trexo
Device”. If unable to connect automatically, check Settings > Wi-Fi in
the tablet and try to connect to “Trexo Device” manually.
Please do not connect your tablet directly to your local wi-fi. The
tablet should only connect to the Trexo device. Internet access
should be connected through the Trexo app only.
The tablet comes pre-loaded with the network information needed to
connect with the device. If you are having trouble connecting, please
contact Trexo at [e-mail] for assistance.
Provide you wi-fi network credentials
and select “connect to Wi-Fi”
2
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Trexo interface – user profile
4
5
3
2
1
6
1. Search by first or last name.
2. List of current profiles.
3. User information.
4. User picture.
5. Edit user information.
6. See previous activity and session information history.
7. Start a new session for selected user.
8. Activity summary since start of usage.
Add new user.
1
2
3
4
5
6
7
8
9
8
9
7
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Trexo interface – user profile
3
2
1
1. Provide user information.
2. Save once ready.
3. Exit without saving.
1
2
3
Note: you may add user picture to the profile after it has been created.
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Trexo interface – activity information
4
5
3
2
1
6
1. Selected user.
2. Summary graphs of the last ten sessions.
3. Session specific history.
4. Menu for summary graphs.
5. Graph summarizing selected usage data.
6. Back to patient profile and selector screen.
1
2
3
4
5
6
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Trexo interface – activity information
43
2
1
1. Selected user.
2. Total number of steps taken during the session.
3. Active walking time.
4. Average cadence during session.
5. Average initiation during session.
6. Total number of sessions and steps taken in a month.
1
2
3
4
5
6
18
6
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Trexo interface – user session
1. Set Trexo legs to standing position.
2. Use to set and adjust gait and support force of device.
3. Take user profile picture.
4. Open Patient Info containing measurements.
5. Current status of device.
Initiation: how often the user is actively helping the Trexo take steps.
6. Speed adjustment controls.
7. Walking time
1
2
3
4
5
6
7
8
19
4
5
3
8
2
17
6
ID / Name
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Quick Trexo joint LED guide
Rotating purple
Joint is powered, not ready to run
due to E-Stop/ not calibrated/ error.
Purple
Joint is ready or running.
Orange
Joint is detecting resistance. Check for
spasticity and stop session if persists.
Blue (hips only)
Child is actively participating.
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