Focal Balancer User manual

Identifier: 606688
Version: 1.0
Date: 1 April 2021
User manual
Balancer

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Disclaimer
The content of this manual is for informational use only and is subject to change without
notice. Focal Meditech BV assumes no responsibility or liability for any errors or inaccuracies
that may appear in this document.
Periodically, changes may be made to the information in this manual; these changes will be
incorporated into new editions of this publication. Focal may make improvements and/or
changes in the products and/or software programs described in this publication at any time.
Copyright Notice
© Focal Meditech BV. All rights reserved.
This manual may only be copied or used within accordance with the terms of the sale
agreement of this product. Except as permitted by agreement, no part of this publication may
be reproduced, stored in any retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, recording, or otherwise, without prior written consent of
Focal Meditech BV.
Address comments about this publication to: [e-mail].
Trademarks and Design
Focal Meditech is a registered trademark of Focal Meditech BV.
Content
Disclaimer 2
Copyright Notice 2
Trademarks and Design 2
Content 3
Manual introduction 5
Symbol explanation 6
Certification Notices 7
Safety notices 8
Contact information 9
Intended use and operation of the device 10
Intended use 10
Intended users 10
Operation of the device 10
Usage of the device 11
Risks and contra-indications 11
Technical information 13
Description 13
Connect and disconnect the wrist strap and or the elbow strap 14
Adjusting the tilting point 15
Connect and disconnect the Human Interface 16
Folding and unfolding the Balancer 17
Adjust the balancing force 18
Rotation 19
Controls 20
Accessories 20
Mounting instructions 21
Maintenance instructions 22
Maintenance hardware 22
Cleaning 22
Reuse 22
Decommissioning 22
Appendix 1 Technical specifications 23
Specifications Balancer 23
Dimensions 24
Appendix 2 Part numbers 25
Appendix 3 Used materials 26
Appendix 4 Declaration of conformity 27
Appendix 5 Conditions and Warranty 28
Conditions and Warranty: Balancer supplied through a representative of Focal Meditech 28
Conditions and Warranty: direct supply by Focal Meditech to consumers 28

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Manual introduction
This is the user manual for Balancer a dynamic arm support system. This product is developed,
manufactured and distributed by Focal Meditech B.V. or one of its authorized representatives.
This manual contains important information regarding Balancer, its intended use and possible
consequences of usage. The aim of this information is to ensure successful, safe and effective
use of the device. This manual contains essential information for using Balancer, information
about safety issues and contact information.
Please read this information carefully: increase of knowledge will result in an increase of
effectiveness. You should also tell people close to you about the main features, for example,
the person who looks after the wheelchair or those who help you with transfers.

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Certification Notices
This is a CE Class I medical device
Do not remove this label. If the label is removed, the
warranty will be void.
This label is positioned at the bottom side of Balancer
Do not remove this label. If the label is removed, the
warranty will be void.
This label is positioned at the bottom side of Balancer
Heavy duty
Symbol explanation
Symbols used in this manual
Danger
This symbol in combination with the word “Danger” is used when there is
important information which can help you avoid the risk of an equipment failure
and serious personal injury or death.
Warning
This symbol in combination with the word “Warning” is used when there is
important information to avoid certain actions that can lead to an equipment
failure.
Caution
This symbol in combination with the word “Caution” is used to warn about
possible unsafe practices. Extra attention is required.
Disposal
This symbol indicates that this product is not to be disposed of with your
household waste, according to the WEEE Directive (2002/96/EC) and your
national law. This product should be handed over to a designated collection
point, e.g., on an authorized one-for-one basis when you buy a new similar
product or to an authorized collection site for recycling waste electrical and
electronic equipment (EEE). Improper handling of this type of waste could
have a possible negative impact on the environment and human health due
to potentially hazardous substances that are generally associated with EEE.
At the same time, your cooperation in the correct disposal of this product will
contribute to the effective usage of natural resources. For more information
about where you can drop off your waste equipment for recycling, please contact
your local city office, waste authority, approved WEEE scheme or your household
waste disposal service.
Packaging
Fragile This way up
Keep away from water Do not stack
Non-sterile product Do not use if package is
damaged

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Contact information
Balancer is manufactured and sold by
Focal Meditech BV
Droogdokkeneiland 19
5026 SP Tilburg
Netherlands
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Internet: www.focalmeditech.nl
Safety notices
Danger: Prevent direct contact with water or any other liquid. Failure of this can lead to
malfunctioning of device or bodily harm.
Danger: Prevent extreme temperature (see environment conditions). Failure of this can
lead to malfunctioning of the device or bodily harm.
Danger: In accordance with the Code VVR, the device must be disconnected from the
wheelchair when the user is transported in the wheelchair by means of transport that is
accessible for wheelchairs. Failure of this can lead to malfunctioning of device or bodily
harm.
Warning: Check for each use that the hinges are properly fixed.
Warning: Do not modify any part of this equipment without authorization of the
manufacturer. Failure of this can lead to malfunctioning and will void the warranty.
Warning: In case of faulty device contact Focal Meditech. Do not try to fix it yourself.
Failure of this will void the warranty.
Warning: In case of doubt about safety of the device contact Focal Meditech.
Warning: In case of a serious incident when using the device, contact Focal Meditech
and the national authority of your country.

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The user of Balancer can use this device in various environments like home, workplace, school
or institutional setting. A restricted tolerance of environmental humidity exists.
Balancer can be mounted on a wheel/working chair or stand.
Balancer is not designed to be used in combinations of large forces. Balancer cannot be used
as a support when standing up or getting seated or as an autonomous lifting device (without
supporting the human arm).
Balancer is not designed to withstand impacts that can be introduced during collisions with a
wall or other objects. Also Balancer is not constructed to withstand high external vertical forces
that can be introduced for example by (abnormal use of) patient hoist systems.
Usage of the device
Balancer supports the execution of numerous daily activities like eating, drinking, tooth
brushing, typing or scratching one’s nose. Independence in lifting and manipulating objects
and in personal care is possible again. In general, it is desirable for users to use their remaining
capacities as much as possible. The device adds force to the user’s arm when lifting objects in
the vertical plane, if well-adjusted no more force is added than strictly is needed. The principle
at work here is called ‘Assist as needed’. Application of this principle is both beneficial from
a health perspective and for one’s self esteem, furthermore it is also cost effective. Balancer
operates on the basis of compensation of the weight of the arm. This is called ‘balancing the
arm’. The large horizontal movements hardly require any effort anymore. The construction
enables easy and quick reach of the mouth and face and easier task performance at the
workplace. Balancer returns the natural freedom of movement to the user.
Danger: In accordance with the Code VVR, the device must be disconnected from the
wheelchair when the user is transported in the wheelchair by means of transport that is
accessible for wheelchairs. Failure of this can lead to malfunctioning of device or bodily
harm.
Warning: If the user experience problems using Balancer, please contact Focal Meditech
or a healthcare professional as soon as possible.
Risks and contra-indications
No essential user risks are known while using Balancer. Balancer is an aid which should be used
by the intended users. However, there are no known contra-indications for Balancer. To be able
to use Balancer the following warnings must be considered.
Intended use and operation of the device
Intended use
Balancer is a dynamic arm support. It is designed for persons having a need for considerable
compensation against gravity during movements of the human arm.
Intended users
The intended users of the dynamic arm support Balancer are users in need of a function device
requiring limited learning efforts:
1 Persons challenged by considerable muscular weakness causing the inability to perform
essential Activities of Daily Living (ADL) activities including eating, drinking, facial care,
computer use, wheelchair control. No problem solving through application of simple arm
supports possible.
2 Persons challenged by excessive muscle functioning.
3 Persons in the need of redistribution of pressure/forces.
4 persons who are at risk for Complaints of Arm Neck and-or Shoulder (CANS), overload or
strong fatigue due to challenging working conditions, which may be due to continuous or
frequent task performance above shoulder level or performance of many static manual
activities.
5 Combinations of these.
Operation of the device
The dynamic arm support system Balancer is a system that consists of several beams which are
interconnected via pivoting points. The beams are connected to a manually adjustable gravity
compensation mechanism. At the distal end of the system an arm fitting and elbow fitting
attached. Balancer is mounted on the ‘solid’ world (wheel or working chair or stand). The lower
arm of the user is placed in the arm fitting, and Balancer can support the weight of the under
and partly the upper arm. The rotatable beam will support movements of the human underarm
and hand.
Balancer has a robust design combined with low friction and low play. This is realised by using
high quality bearing systems combined with high accuracy mechanical parts which results
in a smoothly running system. Therefore, little energy is required to introduce the intended
movements. The smooth-running Balancer combined with the accurate fit of the arm fitting
results in little muscle forces required of the user. The setup of the rotation axis and use of
rope to transmit the balancing force results in a large range of motion. Gravity compensation
characteristics of the device can depend on individual requirements easily be adjusted
Balancer can be used one- or two sided. Several properties of the user being the personal
limitations, possibilities combined with the needs of the user determine if one or two Balancers
are required.

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Technical information
Clamping levers
Human interface
Knob balancing force
Balancing mechanism
Tube for mounting
Mountingloop
Link vertical
Horizontal tube
Vertical tube
Rotation axis
Link rotation
Description
The following parts of Balancer are described
•From a user perspective, the contact point with Balancer is the Human Interface (wrist strap
or wrist with elbow strap) in which the lower arm of the user’s is located. Therefore, the
Human Interface is a component that is individually determined for the user. During use, the
user’s arm must continue to maintain in the Human Interface.
•The cord is used to transfer the forces of the balancing mechanism to the Human Interface.
•The horizontal tube brings the arm fitting into the user’s working area.
•Link rotation can be used to level the horizontal tube or to fold the Balancer. It also provides
a pivoting point in the horizontal plane.
•The vertical tube brings the horizontal tube above the user.
•Both link rotation and link vertical can be used to fold the Balancer.
•The balancing mechanism contains the spring system which generates the balancing force.
In addition, the balancing force can be set using the knob balancing force.
Warning: The arm support system cannot be used by the user as a support when
standing up and sitting down. During the evaluation attention is required to determine
if the user is able to sit in a stable position and if one can stand-up without using a
support.
Warning: Balancer is before all intended to be used by persons challenged by limited
muscle force in their arms and shoulder girdle. Due to diminished use of their
musculoskeletal functions prior to the supply of Balancer and also due to the limited
ability to stabilise and control joints, the risk of initial overburden is present. The user is
at risk of possible overburden of the arm and shoulder, but the possible risk exists for the
whole kinetic chain. The risk of overburden is considered to be the largest shortly after
supply of the device when the user experiences new freedom of movement of arm and
hand. It is advised to gradually build up deployment of the device in cooperation with a
skilled healthcare professional. In collaboration with Focal the user may choose to select
settings that initially protect joints that are at risk for overburden.
Warning: In case of doubt about the safety of the device, the product should not be
used anymore and should be removed from the (wheel)chair. Do not try to fix it yourself
but contact Focal Meditech or its authorized representative. Failure to do this will void
the warranty.
Warning: Balancer does not have parts that can be modified or repaired by the user or
other persons. Do not modify any part of this equipment without the manufacturer’s
authorization. Failure of this can lead to malfunctioning and void the warranty.

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Adjusting the tilting point
Although the Balancer can be used with only a wrist strap, Balancer is most likely equipped
with a wrist strap and elbow strap on a slide bar together also called the Human Interface.
This gives the ability to balance the forearm. To move the arm freely the weight of the arm is
balanced.
Warning: The settings of the tilting point are of great importance for the functioning of
Balancer. Changing these positions can result in a severe decrease of the performance or
even malfunction of Balancer. Therefore, only trained persons are allowed to change the
settings of the tilting point.
The desired tilting point of the forearm can be adjusted by shifting the rod to the front or back.
Find such a balance that the forearm in the Human Interface can easily be tilted forwards and
backwards.
The shifting of the rod can be done after loosening the bolt (in the circle) on the bottom of the
bracket. Shift the rod into the desired position, and tighten the bolt.
The more the rod is slid backwards (towards the elbow), the easier arm and hand are tilted
upwards. If the rod is slid more forward (towards the wrist), then the arm and hand are more
easily tilted down.
Connect and disconnect the wrist strap and or the elbow strap
To make it easier to position the users arm in the Human Interface it is recommended to
disconnect the wrist strap and the elbow strap.
Warning: After connecting the straps make sure that the snap hook is well closed.

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Folding and unfolding the Balancer
The Balancer can be folded when it is not used. This provides a safe setting for the user and the
device. There are to options to fold the Balancer, only the horizontal tube for a quick folding
option or both the horizontal and vertical tubes for a more compact setting.
Warning: Before folding the Balancer make sure that the Human Interface is removed
from the system.
Warning: After folding back, the Balancer make sure that the levers are tighten firmly
however do not overtighten the levers or replace them with a nut.
To fold Balancer, make sure that Human
Interface is removed from the system and
follow the steps.
Folding horizontal bar:
STEP 1: Loosen the lever of the rotation link.
STEP 2: Hold with one hand the vertical tube
and with the other hand the horizontal tube.
STEP 3: Move the horizontal tube 90° down.
STEP 4: Tighten the lever of the rotation link.
Folding vertical bar:
STEP 1: Loosen the lever of the Vertical link.
STEP 2: Hold with one hand the combination
of the vertical with horizontal tube and with
the other hand the mounting tube.
STEP 3: Move the combination 180°
backwards.
STEP 4: Tighten the lever of the vertical link.
Connect and disconnect the Human Interface
When the user wants to fold Balancer, it is recommended that the Human Interface is
disconnected from the system.
Warning: Before disconnecting the Human Interface make sure that the user’s arm
is removed from Balancer.
Warning: After connecting the Human Interface make sure that the snap hook
is well closed
To disconnect the Human Interface, make
sure that the user’s arm is removed out of
the interface and follow the steps.
STEP 1: Make sure that the balance force is set
to the minimum.
STEP 2: Hold with one hand the rope just
above the mounting loop and with the other
hand the slide bar.
STEP 3: Pull the rope with mounting loop to a
comfortable height.
STEP 4: Clip and hold open the snap hook.
STEP 5: Lift the Human Interface in an 45°
angle out of the mounting loop.
STEP 6: Let the rope slowly retract into the
Balancer.
To connect the Human Interface, follow the
steps.
STEP 1: Make sure that the balance force is set
to the minimum.
STEP 2: Hold with one hand the rope just
above the mounting loop and with the other
hand the slide bar.
STEP 3: Pull the rope with mounting loop to a
comfortable height.
STEP 4: Clip and hold open the snap hook.
STEP 5: Lower the Human Interface in an 45°
angle in the opening of the mounting loop.
STEP 6: Let the rope slowly retract into the
Balancer.

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Warning: Adjusting the balancing force can result in forces that are higher than the mass
of the arm, resulting in an upwards movement of the arm.
Rotation
The Balancer has a rotation of 30° to the left and 30° to the right which provide the user to be
able to make the needed horizontal movement.
Warning: Do not change the rotation limitation by yourself inform always a Focal or a by
Focal authorized representative.
Warning: Please note that if the rotation exceeds the footprint of the wheelchair, there
is a risk of collisions against, for example, a door post
The rotation of the Balancer can be changed, however this is depending on couple of variables.
For example the adapter that is used or the type of wheelchair. Detailed information and
installation instructions (how to fixate the adapter) comes with the adapter.
To fold back Balancer, follow the steps.
Fold back vertical bar:
STEP 1: Loosen the lever of the Vertical link.
STEP 2: Hold with one hand the combination
of the vertical with horizontal tube and with
the other hand the mounting tube.
STEP 3: Move the combination 180° forwards.
STEP 4: Tighten the lever of the vertical link.
Fold back horizontal bar:
STEP 1: Loosen the lever of the rotation link.
STEP 2: Hold with one hand the vertical tube
and with the other hand the horizontal tube.
STEP 3: Move the horizontal tube 90° up.
STEP 4: Tighten the lever of the rotation link.
Adjust the balancing force
The upwards balancing force can be adjusted by turning the adjustment knob. The force
required to rotate the adjustment knob can change depending on the position of the Human
Interface. This is normal behaviour and can be used to adjust the system using little force.
Rotating the knob clockwise will give more balancing force, counter clock wise will give less
force.

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Mounting instructions
In order to make stable and safe use of Balancer, there are a couple of mounting brackets
developed for Balancer. The installation instructions (how to fixate the adapter) comes with
the adapter. Most of those adapters will be mounted to the backrest of the wheelchair, the key
point is to find an angle position of the backrests where the user sits comfortably and has the
best possible moving range. The adapter will need to be installed to meet those needs.
Controls
There are no electrical / software controls available for Balancer.
Accessories
There are no accessories available for Balancer.

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Appendix 1 Technical specifications
Specifications Balancer
Mass
• Mass Balancer 2.5 [kg]
Dimensions (in default position)
• Height 778 [mm]
• Width 120 [mm]
• Depth 499 [mm]
Range of motion
• Up/Down At least 800 [mm]
• Forward backward stroke it’s a pendulum [mm]
• Horizontal rotation ± 30 [º]
Balance mass
• Up/Down
• Mass 0...1.5 [kg]
• Mass (heavy duty) 0...3 [kg]
• Mechanic adjustable 0...100 [%]
Mounting position
• Maximum allowed mounting angle -20...20 [º]
Storage conditions
• Temperature -40...85 [ºC]
• Humidity 35...85 [%] non-condensing
Operation conditions
• Temperature -10...+50 [ºC]
• Humidity 35...85 [%] non-condensing
Degree of protection
• IP-class IP40 (IEC60529)
Maintenance instructions
Maintenance hardware
Do not place the device in direct sunlight or in the direct vicinity of a heat source, otherwise
this might result in discolouration or scorching of plastic parts. Direct sunlight may reduce the
lifetime of system parts and interfere with operation.
All housings must be regularly inspected. If any housing is visibly damaged, do not use the
device. It is prohibited to physical modify Balancer. There are no serviceable parts inside
Balancer. Contact Focal Meditech for any maintenance issues.
Cleaning
Maintenance of Balancer is limited. Balancer can be cleaned using a moist cloth and a non-
aggressive cleaning agent.
Reuse
To reuse Balancer, it must be disassembled and reviewed by Focal Meditech or an authorized
professional that is approved by Focal Meditech. Balancer must intensively be cleaned and
inspected. The plastic parts of the buttons can be removed and replaced by new button parts.
The arm fitting and elbow fitting have to be replaced.
Focal Meditech will refurbish and repackage the reused Balancer in such a way that it will meet
the safety and performance requirements according to applicable regulations.
Decommissioning

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Appendix 2 Part numbers
Article number Description
600236 Balancer
600235 Balancer heavy duty
600923 Elbow strap (Small)
600920 Elbow strap (Medium)
600917 Elbow strap (Large)
600926 Elbow strap (X-Large)
603501 Wrist strap (Small)
603499 Wrist strap (medium)
603497 Wrist strap (Large)
603503 Wrist strap (X-Large)
600156 Mounting rod (Small)
600155 Mounting rod (Medium)
600154 Mounting rod (Large)
600157 Mounting rod (X-Large)
601198 Wrist strap with thumb cut-out (Type 1 left)
601200 Wrist strap with thumb cut-out (Type 1 right)
601202 Wrist strap with thumb cut-out (Type 2 left)
601204 Wrist strap with thumb cut-out (Type 2 right)
600616 Adapter clamp ring 20mm (Male)
600615 Adapter clamp ring 20mm (Female)
604932 Adapter clamp ring 22mm (Male)
600618 Adapter clamp ring 22mm (Female)
604292 Mount bracket Sedeo
Dimensions
Dimensions are variable. This is because it is a product with moving parts and it is a product
with different configurations.
499
778
90°
-
0°
90°
90°
-
0°
180°
120
90°
+
-
30°
30°

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Appendix 4 Declaration of conformity
Appendix 3 Used materials
Article number Description Materials used
600236 Balancer Aluminium 6082-T6 +
RVS(AISI 304)
600235 Balancer heavy duty
600923 Elbow strap (Small) Neoprene
600920 Elbow strap (Medium)
600917 Elbow strap (Large)
600926 Elbow strap (X-Large)
603501 Wrist strap (Small) Neoprene
603499 Wrist strap (medium)
603497 Wrist strap (Large)
603503 Wrist strap (X-Large)
600156 Mounting rod (Small) Aluminium 6082-T6 + Mild
steel 1.0038 (S235JRC+C)
600155 Mounting rod (Medium)
600154 Mounting rod (Large)
600157 Mounting rod (X-Large)
601198 Wrist strap with thumb cut-out (Type 1 left) Neoprene
601200 Wrist strap with thumb cut-out (Type 1 right)
601202 Wrist strap with thumb cut-out (Type 2 left)
601204 Wrist strap with thumb cut-out (Type 2 right)
600616 Adapter clamp ring 20mm (Male) Mild steel 1.0038 (S235JRC+C)
600615 Adapter clamp ring 20mm (Female)
604932 Adapter clamp ring 22mm (Male)
600618 Adapter clamp ring 22mm (Female)
604292 Mount bracket Sedeo Mild steel 1.0038 (S235JRC+C)

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Appendix 5 Conditions and Warranty
Conditions and Warranty: Balancer supplied through
a representative of Focal Meditech
Conditions and Warranty in the case of supply through a representative of Focal Meditech are
subject to conditions of the national or local representative and in accordance with national
law.
Conditions and Warranty: direct supply by Focal Meditech to consumers
In the case of direct supply by Focal Meditech to end users, Conditions and Warranty are
subject to the Consumer General Terms and Conditions issued by Koninklijke Metaalunie and in
accordance with Dutch law.

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