Focal Meditech Dowing User Manual

Identifier

872FOCPDWG00ABB876

Version:

0

Date:

30-9-2015

Dowing

User manual

User manual

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: [email protected]

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

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

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

Safety notices

Contact information

Dowing is manufactured and sold by
Focal Meditech BV

Droogdokkeneiland 19
5026SP Tilburg
Netherlands
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]
Internet: www.focalmeditech.nl

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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

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.

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 well­adjusted 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.

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Technical information

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

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

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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).

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

Disconnect the lever

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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

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

Specifications

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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.

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