ORTHOPUS SUPPORTER User manual

ORTHOPUS
SUPPORTER
USER MANUAL
ORTHOPUS
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SYMBOL EXPLANATION 2
INTRODUCTION 3
BACKGROUND 4
WHO ARE THE INTENDED USERS OF THIS DEVICE? 4
USE OF DEVICE 5
INTENDED USE OF DEVICE AND RECOMMENDATIONS 5
CONTRAINDICATIONS 6
TECHNICAL ELEMENTS 6
TECHNICAL INFORMATION 6
DESCRIPTION 7
USAGE 8
INSTALLATION AND UNINSTALLATION 8
Arm cradle adjustments 8
Mounting and dismounting the arm cradle 9
Wheelchair installation 10
Table installation 12
OPERATION 12
SETTING AN IDEAL COMPENSATION FORCE IN FREE MODE 13
SETTING THE UPPER AND LOWER SWING LIMITS IN STATIONARY MODE 14
ACCESSORIES 16
BOX INTERFACE 17
CONTROL BUTTONS 17
MAINTENANCE INSTRUCTIONS 18
CLEANING 18
STORAGE 18
REUSE 18
WARRANTY 19
APPENDICES 19
BROOKE UPPER EXTREMITY RATING SCALE 19
APPLICABLE STANDARDS 20
CE MARKING 21
LABEL 21
TECHNICAL ELEMENTS 21
BOX CONTENTS AND PACKAGING 23
CONTACT INFORMATION 24
ORTHOPUS
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SYMBOL EXPLANATION
In combination with the word, "Warning", this symbol is used to relay vital
information on how to prevent certain actions that may lead to equipment
failure or dangerous practices.
In combination with the word, "Hazard", this symbol is used to relay vital
information that may help you avoid a risk of equipment failure, serious
injury and/or death.
This symbol indicates that the product is not to be disposed of with your
household waste, in accordance with the EEEW (Electrical and Electronic
Equipment Waste) Directive (2002/96/CE) and your country’s legislation.
Improper handling of this type of waste may have a negative impact on the
environment and human health due to potentially-hazardous substances
generally associated with EEE. For more information on where you can
recycle your used equipment, please contact your City Hall, Waste authority,
approved EEEW program or Household Waste Disposal Department.
ORTHOPUS
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INTRODUCTION
This document is the User Manual for the ORTHOPUS Supporter, a dynamic arm support
system manufactured by ORTHOPUS. This manual contains information for installation
and use of this medical device, its safety and contact details. Prior to using it, please
ensure that you read through this document carefully and keep it in a convenient
location where you may refer back to it as needed.
BACKGROUND
The ORTHOPUS Supporter alleviates the weight of the arm so as to facilitate mobility for
those individuals with a reduced range of arm movement. This support system is directly
mounted to an electric wheelchair, as well as to a table or workstation. Non-invasive, this
device is indicated in the case of upper extremity muscle weakness.
The ORTHOPUS Supporter arm support system is a CE-certified, Class I medical device
in accordance with Rule 13 of Appendix VIII of European Regulation 2017/745 on
medical devices.
This device is to be installed by an individual trained specifically for that purpose. We
recommend that users be monitored by a healthcare professional to ensure proper
use of the ORTHOPUS Supporter.
WHO ARE THE INTENDED USERS OF THIS DEVICE?
The ORTHOPUS Supporter has been developed for individuals with:
Residual mobility in the
elbow and shoulder
Mobility in the horizontal
plane (moving the arm
from left to right)
Everyday hand
function
Examples of which may be found below:
●Individuals suffering from muscle weakness, resulting in the inability to carry out
basic day-to-day activities (eating, drinking, using a computer, etc.) and for which
mechanical arm support systems lack sufficient compensation;
●Individuals suffering from arm, neck and/or shoulder pain due to difficult work
conditions (repetitive tasks, heavy loads, static posture, etc.).
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The Brooke Upper Extremity Rating Scale (diagram in the appendix of this document)
may serve, for information purposes, as a frame of reference: The ORTHOPUS Supporter is
intended primarily for individuals at levels 2-4.
USE OF DEVICE
INTENDED USE OF DEVICE AND RECOMMENDATIONS
The ORTHOPUS Supporter is to be mounted to an electric wheelchair, table
or any other similar surface that is both sturdy and of rigid frame with a
thickness ranging between 1 cm and 5.5 cm.
If the ORTHOPUS Supporter cannot be mounted to a table or wheelchair, it
must remain in its packaging and box at all times to avoid falls or other
impacts that may damage the support system. The box is to be kept should
the device need to be returned.
Prior to removing the user’s arm from the support, please always ensure
that the ORTHOPUS Supporter is in STATIONARY or SLEEP mode. The
ORTHOPUS Supporter is designed exclusively to support the arm: it is not
to be used as an aid when standing up or sitting down, or for any other
purpose.
The user may experience joint pain given the newly-acquired ranges of arm
movement from use of the device. To avoid this, it is recommended that the
user become acclimated to the device gradually and be monitored by a
qualified healthcare professional.
In the event of faulty or damaged casings, cables, connectors,
power-operated parts or battery connection, please refrain from using the
device. Should you have doubts regarding the safety of the electronic
devices, the product is no longer to be used, and must be removed from the
wheelchair. Failure to do so may result in loss of warranty. Please contact
your ORTHOPUS Supporter Country Representative for any maintenance
issues.
The ORTHOPUS Supporter does not have parts that may be modified or
repaired by the user or other individuals, except for the custom inlay
components and images on the logo disc. Please do not modify any part of
this equipment without permission from the manufacturer. Failure to do so
may result in a malfunction and the loss of warranty.
When mounting the device, the screws are to be sufficiently tightened and
the appropriate adjustments made. To ensure this, only an individual
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trained specifically for this purpose is authorized to install the ORTHOPUS
Supporter.
This equipment has potential pinch point areas. Please ensure that those
individuals present, children namely, keep their fingers away from the
motor unit when the device is in use.
Please use the device in an appropriate setting:
- Do not place the device in direct sunlight or directly near a source of heat
for an extended period of time.
- The device is water-resistant, but not waterproof. Do not expose it to heavy
rainfall or significant ambient air humidity.
CONTRAINDICATIONS
For those conditions generating joint pain from arm movement, device use
is to be verified and validated by a healthcare professional.
Individuals whose cognitive or behavioral disorders are likely to compromise
proper follow-through of recommendations.
History of dominant upper extremity fractures in the three (3) months prior
to fitting.
Any impairment or injury that may interfere with use of the device.
ORTHOPUS
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TECHNICAL ELEMENTS
TECHNICAL INFORMATION
ORTHOPUS SUPPORTER SETTINGS
Dimensions
Max. length: 765 mm – Min. length: 530 mm
Width: 200 mm
Height at 90°: 320 mm
Load weight
4 kg (includes weight of arm and object held)
Movement speed
0 to 100 mm/s
Average power consumption
4 W for basic usage
Maximum power
consumption
15 W during peak demand
Range of motion
Two (2) symmetrical ranges of motion on arm cradle
possible (Left/Right)
ORTHOPUS
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DESCRIPTION
●The arm cradle (3) is the main part of the ORTHOPUS Supporter in contact with the
user. The user’s arm is positioned in this component lined with an orthopedic fabric
to ensure comfort. The shape and size of the arm cradle are adaptable to each user.
The fastening velcro (5) provides further stability of the arm in the arm cradle.
●The elbow support (4) enables the upper part of the user’s arm to be held in place
when using the device. It helps to keep the arm from slipping out when the user
bends his/her elbow or lifts his/her arm.
●The extender (2) enables the user to move about freely in the horizontal plane.
●The body (1) of the ORTHOPUS Supporter is made up of:
- The actuator (motor unit) (6), enabling movements to be made; and
- The On/Off (Rear) button (7), enabling the user to switch from one mode to
the other, set the position swing limits, and activate the sleep mode on the
device.
●The inlay components and logo disc (8) are the elements that may be customized
based on the user’s preferences.
USAGE
This device features two (2) operating modes. The user has the choice between assisted
movements (FREE mode), mobilizing the residual force, and a STATIONARY mode that
accompanies the arm at all times (STATIONARY mode), enabling movements that
require no effort on behalf of the user.
The ORTHOPUS Supporter may be mounted to the right and/or the left side: an
appropriate arm cradle is available for each side. This allows both arms to be equipped
alternately.
⚠
To fully leverage ORTHOPUS Supporter functionality, it is vital to not only
choose the right size of arm cradle and elbow support, but also adjust
them accordingly. See section below.
Should the user encounter any issues when using the ORTHOPUS Supporter,
please contact your ORTHOPUS Supporter Country Representative or a
healthcare professional as soon as possible.
ORTHOPUS
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INSTALLATION AND UNINSTALLATION
Arm cradle adjustments
To take full advantage of all that the ORTHOPUS Supporter has to offer, proper
adjustments of the arm support are of utmost importance.
Please ensure that:
➔The arm is stabilized in the arm cradle; and
➔The arm is always in contact witch the elbow support. Should you notice that the
arm is not securely in place, or tends to slip out, reposition it accordingly.
To adjust the position of the arm cradle, loosen the adjusting screws, slide the adjustment
bar until the position desired, and then tighten the screws again.
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The elbow support may be adjusted in two (2) directions:
1. Rotation of elbow support: Loosen the elbow support bearing until the elbow
support can be rotated. Adjust the elbow support.
2. Position of elbow support: Loosen one or several screw(s) on the adjustment bar.
Adjust the elbow support by sliding it in the direction of the arrow. Once the
desired distance between the arm cradle and elbow support has been reached,
tighten the adjustment screws again.
The position of both the arm cradle and elbow support is vital to ensuring
optimal user-device interaction and performance. Poor adjustments to these
positions may result in a significant decrease in the performance or even a
malfunction of the ORTHOPUS Supporter. Therefore, only individuals trained
specifically for this purpose are authorized to modify the settings on the arm
cradle and elbow support.
📘
To ensure optimal arm cradle adjustments, please refer to the "Choosing
and Installing the Arm Brace"document on
orthopus.com/en/documentation.
Mounting and dismounting the arm cradle
Please follow the steps below on how to mount the arm cradle, as well as dismount it by
undoing all of the mounting actions.
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The ORTHOPUS Supporter may be mounted to the right and/or left side. An appropriate
arm cradle is available for each side.
Wheelchair installation
⚠
Pictures below are an example with a Permobil wheelchair. To find the
installation details on other wheelchair brands, please refer to the
"Wheelchair installation"document on orthopus.com/en/documentation
1. Take the regular user’ position on the armrest in
picture: please write the inclination down and
mark the arm pad on the armrest in order to
replace it at the exact same place when
reassembling.
2. Dismount the armrest from the wheelchair
(corresponding to the "to-mount" side or side
chosen for device installation).
3. Place the wheelchair attachment with cam
lever ("Wheel-Cam") on the slotted metal plate
underneath the armrest using the screws
already there.
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4. Remount the armrest as per the instructions
provided by the wheelchair manufacturer.
5. The connection to the wheelchair is done
using a cable plugged directly into the Box
interface. (Depending on the model of the
electric wheelchair, connectors may differ.
Please refer to the "WheelchairInstallation"
document.)
6. Plug the cable into the socket along the white
arrow.
📘
For complete instructions on wheelchair installation and the list of
compatible wheelchairs, please refer to the "Wheelchair Installation"
document on orthopus.com/en/documentation.
⚠
If need be, once the ORTHOPUS Supporter has been mounted, lower the
height of the armrest by a few centimeters so as to keep the shoulder from
shifting upwards when using the device.
⚠
Should the armrest be tilted upwards, raise the device to where it is attached,
enabling it to move about freely without touching the armrest.
The Box interface is to be stored on the back of the wheelchair to avoid
contact with water.
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Table installation
Install the table support by tightening the screw (1), and place the ORTHOPUS Supporter
in it (2). Once the device is solidly in place and stabilized, plug in the cables (3).
The ORTHOPUS Supporter is to be mounted to a table or any other similar
surface that is both sturdy and of rigid frame with a thickness ranging
between 1 cm and 5.5 cm.
OPERATION
The ORTHOPUS Supporter is operated using the buttons on the control pad and Rear
button.
Control pad
Rear button
⚠
Prior to removing the user’s arm from the support, please always ensure
that the ORTHOPUS Supporter is in STATIONARY or SLEEP mode.
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STARTING
⚠
While starting the ORTHOPUS Supporter, don’t touch the control pad and
don’t install an arm in the arm brace.
As soon as the device is plugged, it’s automatically in SLEEP mode
Rear button
blinking WHITE
OPERATION
To switch from one mode to the other: 1 LONG click on both buttons of the control pad
(user) or 1 CLICK on the Rear button (caregiver).
A short vibration indicates the switch of mode.
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SETTING AN IDEAL COMPENSATION FORCE IN FREE MODE
1. Switch to FREE MODE.
2. Determine the ideal compensation force using the control
pad (click to increase or decrease in increments of 100 g using
the + and - signs).
3. 1 LONG CLICK on the Rear button to set the ideal force.
4. The short vibration indicates that the force has been set.
Once the compensation force has been set, the user may move the arm without having to
use the buttons.
➔The set compensation force remains in the memory even when the user switches
from one mode to the other, or when the device is off.
➔To modify the force set, repeat the operation with the new force chosen.
➔By default, the compensation force is set at 500g at the first use
SETTING THE UPPER AND LOWER SWING LIMITS IN STATIONARY MODE
1. Switch to STATIONARY MODE.
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2. 1 LONG CLICK on the Rear button to enter in configuration
process
3. Rear button blinking YELLOW = set the UPPER SWING LIMIT
4. Position yourself where you would like to set the upper swing
limit
5. To SET, 1 LONG CLICK on the Rear button
Long vibration = OK
To skip WITHOUT setting, 1 SHORT CLICK
6. Rear button blinking PURPLE = set the LOWER SWING LIMIT.
7. Position yourself where you would like to set the upper swing
limit.
8. To SET, 1 LONG CLICK on the Rear button
Long vibration = OK
To skip WITHOUT setting, 1 SHORT CLICK
9. Back in STATIONARY MODE.
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➔We recommend setting an upper swing limit inferior to the default upper swing
limit so as to keep the arm from slipping out of the arm cradle when raised very
high (image below).
➔Warning: The swing limits may not be set at less than 10° from the horizontal
position of the ORTHOPUS Supporter: gray area on the diagram below.
PARKING POSITION ON ELECTRIC WHEELCHAIR
In STATIONARY mode, pull down the ORTHOPUS Supporter on
the armrest: the device stays blocked in place.
This position can be used for parking the ORTHOPUS
Supporter when it isn’t used or while driving the wheelchair. To
go out of the Parking position, click on the +button of the
control pad.
Rear button
blinking blue
Parking position
activated 🆗
SAFETY IN FREE MODE
If the device is switched in FREE mode without arm in the arm
brace, the ORTHOPUS Supporter puts itself in safety: the Rear
button blinking in green to mark the stop.
The safety is deactivated as soon as an arm is placed in the
arm brace.
Rear button
blinking green
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WARNING LIGHTS
Unplug the device and wait a few minutes before using it
again.
If the Rear button stays red, please contact your ORTHOPUS
Supporter Country Representative.
Rear button
Blinking red
⚠
If this error is repeated several times, please contact your ORTHOPUS
Supporter Country Representative.
ACCESSORIES
BOX INTERFACE
The Box interface refers to the casing that links the various power supply and control
elements to the ORTHOPUS Supporter.
Two (2) types of connections exist depending on how the device is used:
●Use on a table or any other stationary surface requiring a connection to a power
outlet; or
●Use on an electric wheelchair requiring a direct connection to the wheelchair
battery.
ORTHOPUS
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CONTROL BUTTONS
➔The ➕ enables the user to MOVE UP in
STATIONARY MODE or INCREASE the
COMPENSATION FORCE in FREE MODE.
➔The ➖ enables the user to MOVE DOWN in
STATIONARY MODE or DECREASE the
COMPENSATION FORCE in FREE MODE.
The buttons come assembled on the same pad. Should this configuration not be adapted
as needed, it is possible to separate the buttons by unscrewing them from the pad so as to
reconfigure them in a way that is best suited to the user.
Connection of the buttons to the Box interface must be done in accordance
with the ➕ and ➖ symbols appearing on the image below.
Our device functions with standard control buttons found in stores. That said, please
contact your Country Representative to ensure compatibility.
CUSTOM ELEMENTS
The device is made up of elements that may be chosen by the user:
●a set of interchangeable custom inlays (eight (8) colors possible); and
●the image, or logo disc, found on each side of the motor unit that may be changed
as often as the user likes.
📘
Please find all the information related to changing the image on each logo
disc (size, orientation, etc.) on orthopus.com/documentation.
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➔Magnets may be found underneath the custom inlays and each logo disc, enabling
easy removal of them. These elements do not allow access to the critical parts of
the device (circuit board, motor unit, etc.), and may, therefore, be handled without
any risk to the user.
MAINTENANCE INSTRUCTIONS
CLEANING
The ORTHOPUS Supporter may be cleaned using a damp towel and gentle, non-abrasive
product. Do not put the ORTHOPUS Supporter in water.
STORAGE
The device is to be stored in a dry, dust-free location.
Whether for transport, storage or returns, the packaging and cut-to-size foam are to be
used.
REUSE
For the purposes of reuse, the ORTHOPUS Supporter is to be disassembled and reviewed
by an ORTHOPUS-trained professional or its distributor.
The ORTHOPUS Supporter is to be cleaned and disinfected between users.
The plastic parts of the buttons may be removed and replaced with new ones. The
orthopedic fabric lining the arm cradle, as well as the custom inlays, may be changed.
The ORTHOPUS Supporter will be refurbished and repackaged so as to comply with the
essential safety and performance requirements in accordance with enforceable
regulations.
ORTHOPUS
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