Focal Balancer, User Manual

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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.