Focal Meditech Dowing User manual

User manual
Identifier
872FOCPDWG00ABB876
Version:
0
Date:
30-9-2015
Dowing
User manual

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Disclaimer
The content of this manual is furnished for informational use only, is subject to change without notice,
and should not be construed as a commitment by Focal Meditech BV. Focal assumes no responsibility
or liability for any errors or inaccuracies that may appear in this document. Changes are periodically
made to the information herein; 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.
Dowing is a registered trademark of Focal Meditech BV.
Dowing Model Design is registered by Focal Meditech BV.

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Content
Disclaimer................................................................................................................................................ 2
Copyright Notice...................................................................................................................................... 2
Trademarks and Design.......................................................................................................................... 2
Content.................................................................................................................................................... 3
Manual introduction ................................................................................................................................. 4
Symbol explanation ................................................................................................................................. 5
Certifications Notices............................................................................................................................... 6
Safety notices.......................................................................................................................................... 6
Contact information ................................................................................................................................. 6
Intended use and operation of the device............................................................................................... 7
Operation of the device.................................................................................................................... 7
Intended use of the device............................................................................................................... 7
Usage of the device.......................................................................................................................... 8
Risks and contra-indications ............................................................................................................ 8
Technical information .............................................................................................................................. 9
Description ....................................................................................................................................... 9
Adjusting the arm swing, arm fitting and elbow fitting.................................................................... 10
Disconnect the lever....................................................................................................................... 10
Remove Dowing............................................................................................................................. 11
Controls ................................................................................................................................................. 12
Accessories ........................................................................................................................................... 12
Mounting instructions............................................................................................................................. 12
Maintenance instructions....................................................................................................................... 12
Maintenance hardware................................................................................................................... 12
Cleaning ......................................................................................................................................... 12
Reuse............................................................................................................................................. 12
Decommissioning........................................................................................................................... 12
Appendix 1 Technical specifications ..................................................................................................... 13
Specifications ................................................................................................................................. 13
Appendix 2 Part numbers...................................................................................................................... 14
Appendix 3 Used materials.................................................................................................................... 15
Appendix 4 Mounting instructions Dowing ............................................................................................ 16
Appendix 7 Declaration of conformity.................................................................................................... 17
Appendix 8 Conditions and Warranty.................................................................................................... 18
Conditions and Warranty: supply through a representative of Focal Meditech ............................. 18
Conditions and Warranty: direct supply by Focal Meditech BV to consumers .............................. 18

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Manual introduction
This is the user manual for Dowing, a dynamic arm support system. This product is developed,
manufactured and possibly distributed by Focal Meditech B.V. This manual contains the information
regarding Dowing, the intended use and the consequences of usage. The aim of this information is to
ensure successful, safe and effective use of the device. This manual contains the essential information
for using Dowing, safety issues and contact information.
Please read this information carefully: the increase of knowledge of the arm support will result in an
increase of the effectiveness. Remark: always keep this user manual in a convenient location for easy
reference.

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Symbol explanation
Symbols used in user manual
Warning!
This symbol is used when there is important information which
can help you avoid the risk of serious personal injury or death.
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

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Certifications Notices
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:
During installation ensure there is at least a fuse of 5A between power supply
and Dowing. Failure of this can lead to malfunctioning of the device and bodily
harm
Warning:
Do not modify any part of this equipment without authorization of the
manufacturer. Failure of this can lead to malfunctioning and loss of warranty
Warning:
In case of faulty device contact Focal. Do not try to fix it yourself. Failure of this
can lead to loss of warranty
Warning:
In case of doubt about safety of the device contact Focal
Contact information
Dowing is manufactured and sold by
Focal Meditech BV
Droogdokkeneiland 19
5026SP Tilburg
Netherlands
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Internet: www.focalmeditech.nl
This is a CE Class I medical device
Classification cf. Dutch Cliq 2013:
241827030309
Dynamic Arm Supports, compensation of diminished muscle function and
change of range of motion, load arm construction, hybrid actuation
241827060309
Dynamic Arm Supports, managing excessive muscle functioning, hybrid
actuation
241827090309
Dynamic Arm Supports, redistribution of pressure/forces, hybrid actuation
241827990306
Forearm support
241827990900
Axis locking

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Intended use and operation of the device
Operation of the device
The dynamic arm support system Dowing is a system that consists of several axes which are
interconnected via pivoting points. The axes are connected to a manually adjustable gravity
compensation mechanism. At the distal end of the system an arm fitting, elbow fitting and optional a
wrist support are attached. Dowing is mounted on the ‘solid’ world (table or working chair). The under
arm of the user is placed in the arm fitting, and Dowing can support the weight of the under and partly
the upper arm. The axes of Dowing will support movements of the human underarm and hand.
Dowing 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 Dowing combined with the accurate fit of the arm fitting results in little muscle forces required
of the user. The kinematic chain of the axes results in a large range of motion. Gravity compensation
characteristics of the device can depending on individual requirements easily be adjusted
The intended users of the dynamic arm support Dowing are:
1. Persons challenged by muscular weakness causing the inability to perform essential Activities
of Daily Living (ADL) activities including eating, drinking, facial care, computer use. Dowing’s
users are not requiring frequent or dynamic adjustments.
2. Persons challenged by excessive muscle functioning –ditto.
3. Persons in the need of redistribution of pressure/forces - ditto.
4. Combinations of these.
5. Persons who do not suffer from one or more of the above mentioned medical conditions but
who are at risk for such conditions e.g. due to repetitive movements, work above shoulder
height or precision work. Being at risks may include the consequences of Complaints of Arm
Neck and-or Shoulder (CANS) and similar work related disorders.
In the need of a functional device requiring limited learning efforts.
Intended use of the device
Dowing is a medical device. It is primarily designed for persons having a need for compensation of
muscle force. Depending upon personal (dis)abilities Dowing may also diminish the effects of
excessive muscle functioning (guide spastic movements). Further, Dowing will redistribute pressures
and forces of the arm and shoulder concerned and can possibly diminish pain in the shoulder girdle .
Dowing 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 Dowings are required.
The user of Dowing can use this device in various environments like home, workplace, school or
institutional setting. A restricted tolerance of environmental humidity exists.
Dowing can be mounted on a table or working chair. Due to safety and functional reasons, Dowing
should not be mounted on a (electric) wheelchair.
The intended use of Dowing also includes the application as an ergonomic aid for 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.
Dowing is not designed to be used in combinations of large forces. Dowing cannot be used as a
support when standing up or getting seated or as an autonomous lifting device (without supporting the
human arm).
Dowing is not designed to withstand impacts that can be introduced during collisions with a wall or
other objects. Also Dowing is not constructed to withstand high external vertical forces that can be
introduced for example by (abnormal use of) patient hoist systems.

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Usage of the device
Dowing 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. Dowing 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. Dowing returns the natural freedom of movement to the user.
Risks and contra-indications
No essential user risks are known while using Dowing. Dowing is an aid which should be used by the
intended users. However there are no known contra-indications for Dowing. To be able to use Dowing
the following warnings must be taken into account.
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:
Dowing 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 Dowing 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:
Dowing 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 authorization of
the manufacturer. Failure of this can lead to malfunctioning and loss of
warranty
Warning:
For safety reasons, Dowing can only be removed from the locking position
when the user’s arm is correctly positioned in the arm fitting.

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Technical information
Description
The following parts of Dowing are described
From a user perspective the contact point with Dowing is the arm fitting where the under arm
of the user is positioned in..
The elbow fitting. The upper arm of the user should be in contact with this part during the use
of Dowing.
The optional wrist support. This part can be used to support the wrist and hand. This wrist
support can be shifted and can be removed. The support itself can rotate.
The arm swing with pivoting base plate which holds the arm fitting, elbow fitting and the wrist
support.
Locking pawl.
The lever is connecting the arm, elbow fittings and the wrist support to the body of Dowing.
At the top of Dowing there are two red buttons. Pressing these two buttons towards each other
makes it possible to remove the lever, arm swing containing the arm fitting, elbow fitting and
the optional wrist support.
Body of Dowing. The body of Dowing contains: -the balancing system including the possibility
to adjust the balancing force.
Balancing force adjustment knob.
Swivel arms
Level rotation head
Clamp
Armfitting
Elbow fitting
Lever
Body
Locking pawl
Arm swing with pivoting base plate
Wrist support
Buttons
Level rotation head
Balancing force
adjustment knob
Swivel arms
Clamp

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Adjusting the arm swing, arm fitting and elbow fitting
Warning:
The positions of arm fitting and elbow fitting are crucial for the performance of
Dowing. Changing these positions can result in a severe decrease of the
performance or even malfunction of Dowing. Therefore only trained persons are
allowed to change the settings of the arm fitting and elbow fitting.
Warning: adjusting the arm fitting can
result in malfunction of Dowing.
The arm fitting can be adjusted in one direction
Adjusting the position of the arm fitting. Loose
one or multiple screws (A). Adjust the arm fitting
by shifting this fitting. Fasten all screws (A).
Warning: adjusting the elbow fitting can
result in malfunction of Dowing for the
user.
The elbow fitting can be adjusted in two
directions:
1. Adjusting the rotation of the elbow
fitting: loose screw (B) until the fitting
can be rotated. Adjust the fitting and
fasten the screw (B).
2. Adjusting the position of the elbow
fitting: loose one or multiple screws (C).
Adjust the elbow fitting by shifting this
fitting. Fasten all screws (C).
Disconnect the lever
The lever including the arm swing, arm fitting,
elbow fitting and wrist support can be removed
easily. To disconnect the lever, press both red
buttons at the top of Dowing, and move the lever
away from the body in the upwards direction.
Replacing the lever can be done by pushing the
lever into the body. The buttons do not have to
be pushed. When the lever is in position, it
cannot be removed without pressing the buttons.
Screw B
Screws C
Screws A
Red buttons

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Remove Dowing
Dowing can easily be removed from the table or
chair clamp.
Remove Dowing
Step 1: Lock Dowing in the parking position
Step 2: Remove the user’s arm
Step 3: Remove Dowing from the parking
position. Warning: the arm fitting will move
upwards due to the spring
Step 4: Remove the lever
Step 5: Hold with one hand the body of Dowing;
lift with the other hand the lower extension arm
from the clamp
Step 6: Store Dowing in its case
Replace Dowing
Step 1: Position Dowing above the clamp
Step 2: Lower Dowing
Step 3: Attach the lever
Step 4: Position the user’s arm in the arm fitting

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Controls
--
Accessories
--
Mounting instructions
-
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 Dowing. There are no serviceable parts inside Dowing. Contact Focal for
any maintenance issues.
In case Dowing is not mounted on the mounting base it should always be stored in the case to prevent
falling or other impacts that can damage the system.
Cleaning
Maintenance of Dowing is limited. Dowing can be cleaned using a moist cloth and a non-aggressive
scour.
Reuse
To reuse Dowing, it has to be disassembled by a professional. Dowing 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.
Decommissioning

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Appendix 1 Technical specifications
Specifications
Dowing
Range of motion
Up/Down
490
[mm] @ end of lever
Forward/Backward stroke
390
[mm] @ end of lever
Horizontal rotation
unlimited
Balance mass
Up/Down
Mass
0.25 to 5
[kg] @ end of lever
Rotation block tilt function
Angle
-20 .. 20
[°]
Mass
Dowing body
6.8
[kg]
Storage
Temperature
-40 .. 85
[°C]
Humidity
35 .. 85
[%] non condensing
Mounting position
Maximum allowed mounting angle
-20..20
[°]
Operating
Temperature
-10 .. 50
[°C]
Humidity
35 .. 85
[%] non condensing
Degree of protection (DIN 40050)
IP40

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Appendix 2 Part numbers
872FOCSADWG**ABB817
Dowing
872FOCSADWG**ABB819
Table mount
872FOCSADWG**ABB885
Chair mount
872FOCSAGWG**ABB122
Loadarm with arm swing right (Large)
872FOCSAGWG**ABB123
Loadarm with arm swing left (Large)
872FOCSAGWG**ABB212
Loadarm with arm swing left (X-Large)
872FOCSAGWG**ABB213
Loadarm with arm swing right (X-Large)
872FOCSAGWG**ABB144
Subassembly wrist support (Right)
872FOCSAGWG**ABB145
Subassembly wrist support (Left)
872FOCSAGWG**ABB140
Subassembly Elbow fitting Left (Large)
872FOCSAGWG**ABB141
Subassembly Elbow fitting Right (Large)
872FOCSAGWG**ABB214
Subassembly Elbow fitting Left (Small)
872FOCSAGWG**ABB215
Subassembly Elbow fitting Right (Small)
872FOCSAGWG**ABB130
Subassembly Armfitting size 1 Right
872FOCSAGWG**ABB131
Subassembly Armfitting size 1 Left
872FOCSAGWG**ABB132
Subassembly Armfitting size 2 Right
872FOCSAGWG**ABB159
Subassembly Armfitting size 2 Left
872FOCSAGWG**ABB133
Subassembly Armfitting size 3 Right
872FOCSAGWG**ABB134
Subassembly Armfitting size 3 Left
872FOCSAGWG**ABB135
Subassembly Armfitting size 4 Right
872FOCSAGWG**ABB136
Subassembly Armfitting size 4 Left
872FOCSAGWG**ABB631
Subassembly Armfitting size 5 Right
872FOCSAGWG**ABB630
Subassembly Armfitting size 5 Left
**) means each number between 00 and 99 (for internal use Focal)

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Appendix 3 Used materials
Part
Focal number
Material
872FOCSADWG**ABB878
Subassembly Dowing
Aluminium 6082T6+
RVS(AISA 304)
872FOCSADWG**ABB819
Subassembly Table clamp
Aluminium 6082T6+
RVS(AISA 304)
872FOCSADWG**ABB885
Subassembly Chair clamp
Aluminium 6082T6+
RVS(AISA 304)
872FOCSAGWG**ABB122
Load arm with arm swing
Aluminium 6082T6+Aisi +
RVS(AISA 304)
872FOCSAGWG**ABB123
872FOCSAGWG**ABB212
872FOCSAGWG**ABB213
872FOCSAGWG**ABB144
Subassemblies wrist support
Aluminium 6082T6+Aisi +
RVS(AISA 304) +
NEOPRENE+
Celrubber+
POM
872FOCSAGWG**ABB145
872FOCSAGWG**ABB140
Subassemblies Elbow fitting
Aluminium 6082T6+Aisi +
RVS(AISA 304) +
NEOPRENE+
Celrubber+
POM
872FOCSAGWG**ABB141
872FOCSAGWG**ABB214
872FOCSAGWG**ABB215
872FOCSAGWG**ABB130
Subassemblies Arm fitting
Aluminium 6082T6+Aisi +
NEOPRENE+
POM
872FOCSAGWG**ABB131
872FOCSAGWG**ABB132
872FOCSAGWG**ABB159
872FOCSAGWG**ABB133
872FOCSAGWG**ABB134
872FOCSAGWG**ABB135
872FOCSAGWG**ABB136
872FOCSAGWG**ABB630
872FOCSAGWG**ABB631

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Appendix 4 Mounting instructions Dowing
Assembly of a left arm support.

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Appendix 7 Declaration of conformity
WE:
MANUFACTURER:
Focal Meditech B.V.
ADDRESS:
Droogdokkeneiland 19
5026 SP Tilburg Netherlands
TEL:
[phone]
FAX:
[phone]
WEBSITE:
www.focalmeditech.nl
HEREBY DECLARE THAT THE DEVICE:
DEVICE (MODEL):
DESCRIPTION
872FOCSADWG**ABB817
Subassembly Dowing
872FOCSADWG**ABB819
Subassembly Table clamp
872FOCSADWG**ABB885
Subassembly Chair clamp
872FOCSAGWG**ABB122
Loadarm with arm swing right (Large)
872FOCSAGWG**ABB123
Loadarm with arm swing left (Large)
872FOCSAGWG**ABB212
Loadarm with arm swing left (X-Large)
872FOCSAGWG**ABB213
Loadarm with arm swing right (X-Large)
872FOCSAGWG**ABB144
Subassembly wrist support Right
872FOCSAGWG**ABB145
Subassembly wrist support (Left)
872FOCSAGWG**ABB140
Subassembly Elbow fitting Left (Large)
872FOCSAGWG**ABB141
Subassembly Elbow fitting Right (Large)
872FOCSAGWG**ABB214
Subassembly Elbow fitting Left (Small)
872FOCSAGWG**ABB215
Subassembly Elbow fitting Right (Small)
872FOCSAGWG**ABB130
Subassembly Armfitting size 1 Right
872FOCSAGWG**ABB131
Subassembly Armfitting size 1 Left
872FOCSAGWG**ABB132
Subassembly Armfitting size 2 Right
872FOCSAGWG**ABB159
Subassembly Armfitting size 2 Left
872FOCSAGWG**ABB133
Subassembly Armfitting size 3 Right
872FOCSAGWG**ABB134
Subassembly Armfitting size 3 Left
872FOCSAGWG**ABB135
Subassembly Armfitting size 4 Right
872FOCSAGWG**ABB136
Subassembly Armfitting size 4 Left
872FOCSAGWG**ABB631
Subassembly Armfitting size 5 Right
872FOCSAGWG**ABB630
Subassembly Armfitting size 5 Left
COMPLY WITH THE FOLLOWING STANDARDS:
NUMBER
TITLE
EN ISO 14971
Medical devices - Application of risk management to medical
ISO 10993-1
Biological evaluation of medical devices - evaluation and testing
EN12182
Assistive products for persons with disability - General requirements and test methods
IEC 60601-1
Medical electrical equipment : General requirements for basic safety and essential
performance
IEC 62079
Preparation of instructions
AND IF APPLICABLE, COMPLY WITH THE FOLLOWING DIRECTIVES:
NUMBER
TITLE
93/42/EEC
Medical Device Directive
89/336/EEC
Electromagnetic Compatibility Directive
73/23/EEC
Low Voltage Equipment Directive
93/68/EEC
CE Marking Directive
WITH LVFS 2001:6 TRANSPONDING THE EUROPEAN MEDICAL DEVICE DIRECTIVE 93/42/EEC.
SIGNED AT:
Tilburg, The Netherlands
P.C.M. Groenland
Directeur
DATE:
1-10-2014
SIGNATURE:

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Appendix 8 Conditions and Warranty
Conditions and Warranty: supply 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 paying parties being consumers, Conditions and
Warranty are subject to the Consumer General Terms and Conditions V. 2014 issued by Koninklijke
Metaalunie and in accordance with national law.