Focal Meditech SLING User manual

Identifier: 606691
Version: 1.0
Date: 1 April 2021
User manual
Sling

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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 12
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 Sling 17
Adjust the balancing force 18
Rotation 19
Removing and placing 20
Adjusting the Level unit 21
Controls 22
Accessories 22
Mounting instructions 23
Maintenance instructions 24
Maintenance hardware 24
Cleaning 24
Reuse 24
Decommissioning 24
Appendix 1 Technical specifications 25
Specifications Sling 25
Dimensions 26
Appendix 2 Part numbers 27
Appendix 3 Used materials 28
Appendix 4 Declaration of conformity 29

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Manual introduction
This is the user manual for Sling 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 Sling, 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 Sling, 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.
Appendix 5 Conditions and Warranty 30
Conditions and Warranty: supplied through a representative of Focal Meditech 30
Conditions and Warranty: direct supply by Focal Meditech BV to consumers 30

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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 of the vertical
tube of the Sling
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
Sling 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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Usage of the device
Sling 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. Sling 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. Sling
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 Sling, please contact Focal Meditech or a
healthcare professional as soon as possible.
Intended use and operation of the device
Intended use
Sling 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 Sling 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 Sling is a set of axes equipped with a string. The string connects an
arm-fitting (Human Interface) with a counterweight. The Sling will always be attached to the
'fixed' world (chair, wheelchair or frame). The forearm rests in the Human Interface, the Sling
can now largely bear the weight of the arm and relieve the pectoral girdle. The counterweight
will allow every movement of the arm and hand against gravity. Dynamic arm supports are
mainly used by people with limited strength in the pectoral girdle or arm due to neurological
or orthopaedic state of these areas. By using their own residual capabilities, these people can
move their hands to where it is useful. Reaching, grasping, moving things and all kinds of
everyday activities are now possible. The Sling works in both the horizontal and the vertical
way and requires no electrical power. A typical feature of the Sling is that the whole suspension
approaches the user’s arm from above. In this way, unlike other types of arm support, there
are no parts under the arm that may occupy space. Arm support systems of this type are very
suitable in case the device could come into conflict with objects such as the working table,
joystick, armrest or keyboard. As a result, the Sling is used by people with their own capabilities
and desires.

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Technical information
Level unit
Lock-out rotation
Rotation head
Vertical tube
Lock knob
Lock knobs slider
Slider
Lineair translation
Human interface
Mountingloop
Carrier
Description
The following parts of Sling 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 counter weight in the vertical tube to the
Human Interface.
•The linear translation combined with the carrier brings the arm fitting into the user's
working area.
•The Slider can be used to unblock the fold axis, it will be hold in place by two thumbscrews.
•Rotation head provides a pivoting point in the horizontal plane it can be locked out by
lockout knob.
Risks and contra-indications
No essential user risks are known while using Sling. Sling is an aid which should be used by
the intended users. However, there are no known contra-indications for Sling. To be able to use
Sling the following warnings must be considered.
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: Sling 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 Sling 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: Sling 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 Sling can be used with only a wrist strap, Sling 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 arm fitting are of great importance for the functioning of
Sling. Changing these positions can result in a severe decrease of the performance or
even malfunction of Sling. Therefore, only trained persons are allowed to change the
settings of the Human Interface.
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 arm fitting 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.
•The vertical tube brings the linear translation above the user and provides room and
guidance for the counter weight.
•The lock knob can be used to easily take of Sling.
•Level unit can be used to level the vertical tube perpendicular to the gravity plane.
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 hooks are well closed.

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Folding and unfolding Sling
The Sling can be folded when it is not used. This provides a safe setting for the user and the
device.
Warning: Before folding the Sling make sure that the Human Interface is removed from
the system.
Warning: After folding back, the Sling make sure that the thumbscrews are tighten
firmly however do not overtighten the screws or replace them with a bolt.
To fold Sling, make sure that Human Interface is removed
from the system and follow the steps.
Folding linear translation:
STEP 1: Loosen the two thumbscrews.
STEP 2: Hold with one hand the linear translation and slide
with the other hand the slider away from the rotation
head.
STEP 3: Move the linear translation 90° down.
STEP 4: Tighten the thumbscrews to prevent losing them.
Folding back linear translation:
STEP 1: Loosen the two thumbscrews.
STEP 2: Move the linear translation 90° up.
STEP 3: Hold with one hand the linear translation and slide
with the other hand the slider towards the rotation head.
STEP 4: Tighten the thumbscrews to lock the slider.
Connect and disconnect the Human Interface
When the user wants to fold Sling, 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 the system.
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: Hold with one hand the rope just
above the mounting loop and with the other
hand the slide bar.
STEP 2: Pull the rope with mounting loop to a
comfortable height.
STEP 3: Clip and hold open the snap hook.
STEP 4: lift the Human Interface in an 45°
angle out of the mounting loop.
STEP 5: let the rope slowly retract into the
balancer.
To connect the Human Interface, follow the
steps.
STEP 1: Hold with one hand the rope just
above the mounting loop and with the other
hand the slide bar.
STEP 2: Pull the rope with mounting loop to a
comfortable height.
STEP 3: Clip and hold open the snap hook.
STEP 4: lower the Human Interface in an 45°
angle in the opening of the mounting loop.
STEP 5: let the rope slowly retract into the
balancer.

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Rotation
The Sling has a rotation of 45° to the left and 45° 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 please contact Focal
Meditech or a by Focal authorized healthcare professional.
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
Although the rotation of the system can be
changed, this should be done Focal Meditech
or a by Focal authorised professional. Always
keep in mind that the linear translation does
not exceeds the footprint of the wheelchair.
Adjust the balancing force
The balancing force in Sling consists of a counter weight which is placed in the vertical tube.
However, the possibility to change the counter weight is limited.
Warning: Adjusting the counter weight can result in forces that are higher than the mass
of the arm, resulting in an upwards movement of the arm
The balancing force can be adjusted by
removing or adding addable weights. To
change the counterweight, it is necessary to
fold the Sling first.
To add weight, couple the weight by tighten
the setscrew above the relevant weight. And
loosen the setscrew below the weight.

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Adjusting the Level unit
The optimal performance of Sling will be reached when the linear translation is perpendicular
to the gravity plane. However, it is in some cases needed or desirable to use an off-level setup.
Warning: The settings of the level unit are of great importance for the functioning of
Sling. Changing these settings can result in a severe decrease of the performance or even
malfunction of Sling. Therefore, only trained persons are allowed to change the settings
of the level unit.
Warning: After adjusting the level unit make sure that the centre bolt is tighten firmly
however do not overtighten the bolt.
The required angle of the level unit depends on a number of factors. For example, a correction
must be made for the angular error that arises during mounting. But even when the user
cannot move in as well, it is an option to set the angle so that the linear translation falls slightly
inward.
Before the level unit can be adjusted, the Sling must be removed from it. There is a bolt in
the middle of the level unit. The three level bolts on the outside can be turned after the bolt
in the middle has been loosened. Turning in the level bolts (viewed clockwise from above)
shifts the center of gravity in the direction of the respective level bolt. By loosening a level bolt
(counter clockwise seen from above) the centre of gravity shifts in the direction opposite to the
respective level bolt. Any angle can be set with the three level bolts together.
After adjusting the level unit make sure that the centre bolt is tighten firmly however do not
overtighten the bolt.
Removing and placing
The Sling can be removed if it is not used for a longer time. This provides a safe setting for the
user and the device.
Warning: Before removing Sling make sure that the Human Interface is removed from
the system and Sling is folded.
Warning: After replacing Sling make sure that the bolts are tighten firmly however do
not overtighten the them.
Removing Sling:
STEP 1: Loosen the wing screw.
STEP 2: Lift the Sling in a vertical movement so that it is released from the level unit.
STEP 3: Tighten the wing screw to prevent losing it.
Placing Sling:
STEP 1: Loosen the wing screw.
STEP 2: Lower the Sling in a vertical movement so that it is slides into the level unit.
STEP 3: Tighten the wing screw to lock the sling into place.

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Mounting instructions
In order to make stable and safe use of Sling, there are a couple of mounting brackets
developed for Sling. 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 Sling.
Accessories
There are no accessories available for Sling.

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Appendix 1 Technical specifications
Specifications Sling
Mass
• Mass Sling 2.5 [kg]
Dimensions (in default position)
• Height 712 [mm]
• Width 80 [mm]
• Depth 579 [mm]
Range of motion
• Up/Down depends on counterweight
• Forward backward stroke 220 [mm]
• Horizontal rotation ± 45 [º]
Balance mass
• Up/Down
• Mass 0.20...3 [kg]
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 Sling. There are no serviceable parts inside Sling.
Contact Focal Meditech for any maintenance issues.
Cleaning
Maintenance of Sling is limited. Sling can be cleaned using a moist cloth and a non-aggressive
cleaning agent.
Reuse
To reuse Sling, it has to be disassembled by a professional. Sling must intensively be cleaned
and inspected. The plastic parts of the buttons can be removed and replaced by new button
parts.
The Human Interface have to be replaced.
Focal Meditech will refurbish and repackage the reused Sling 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
Focal number Description
603900 till
603908
Sling (mechanical)
603909 till
603917
Sling (electrical)
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. All dimensions are given in [mm] millimetres.
215
-
0
215
579
90°
+
-
45°
45°
90°
-
0°
90°
712
80

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Appendix 4 Declaration of conformity
Appendix 3 Used materials
Focal number Description Materials used
603900 till
603908
Sling (mechanical) Aluminium 6082-T6
+ RVS(AISI 304)
603909 till
603917
Sling (electrical)
600923 Elbow strap (Small) Neoprene
600920 Elbow strap (Medium)
600917 Elbow strap (Large)
600926 Elbow strap (X-Large)
600923 Elbow strap (Small) Neoprene
600920 Elbow strap (Medium)
600917 Elbow strap (Large)
600926 Elbow 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: 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 BV to consumers
In the case of direct supply by Focal Meditech BV 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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