Company
Document:
Clinical Evaluation for
Power add-ons
Page of total:
1 / 17
Change date:
---
Clinical Evaluation
Version:
1
ULRICH ALBER GMBH, ALBSTADT, GERMANY
Clinical Evaluation
for
power add-ons
The document is established
according to the MEDDEV 2.7.1
„Evaluation of clinical data: A
guide for Manufacturers and Notified
Bodies“
Author:
Date :
M. Brunner
24.08.2011
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Clinical Evaluation for
power add-on viamobil V25
Clinical Evaluation
Document:
Page of total:
2 / 17
Change date:
---
Version:
1
1. General Details
The power add-on unit viamobil V25 is classified as a Class I
product according to the Medical Device Directive 93/42/EEC.
viamobil V25 is a push and brake aids for manual wheelchairs.
Its purpose is to make pushing and braking a manual
wheelchair easier and safer for the attendant. viamobil is
not used by the wheelchair driver. All manual wheelchairs
tested and approved for combination are mentioned in the
Alber bracket list. The product is basically sold worldwide.
Viamobil V25 is assembled at the Ulrich Alber GmbH, Vor dem
Weißen Stein 21, 72461 Albstadt-Tailfingen, Germany.
Due to the fact that viamobil V25 has no therapeutic or
diagnostic purpose as it is not used by the wheelchair driver
himself, the evaluation was directed toward the state of the
art, existing, well-established technologies on powered
wheelchair design, safety, conform use and reporting of
negative side effects known in literature.
2. Description of the device
The product described does not perform any therapeutical or
diagnostic purpose.
The product is used to:
 Compensate a mobility impairment by allowing the
wheelchair driver´s attendant to push the wheelchair
easier.
2.1 Clinical
Intended use:
No clinical use for wheelchair driver.
Contradictions:
None known
Author:
Date :
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Clinical Evaluation for
power add-on viamobil V25
Clinical Evaluation
Document:
Page of total:
3 / 17
Change date:
---
Version:
1
Application range:
Powered wheelchairs are medical devices due to the MDD
93/42/EEC, in accordance with article 1, paragraph 2a they
are ranked as devices to the compensation of injuries and/or
handicaps. According to appendix IX of the MDD 93/42/EEC
powered wheelchairs are class 1 devices. CE marking applies
to all powered wheelchairs in accordance with appendix VII of
the guideline.
Moreover, the product is classified according to EN 12184 as
class B mobility product (for use in indoor and outdoor
areas). These class B indoor and outdoor products are able to
overcome many obstacles in outdoor areas. All technical data,
such as speed, turning radius, range, safe climbing ability,
maximum obstacle height and permissible operating conditions
can be found in the user manual, chapter "Technical Data"
(chapter 1.6). The vehicle is successfully tested according
to German and international standards concerning its safety.
Place of application:
The place of application is related to the class according to
EN 12184, which is for viamobil class B (for use in indoor
and outdoor areas). Dangerous ground and dangerous situations
as described in the user manual (chapter 10) are to be
avoided.
User group:
For the viamobil V25 the maximum person weight is 160kg. The
permissible overall weight is 210kg. Slopes and gradients up
to 18% can be safely traversed (depending on the user´s
weight). For example with 160 kg the maximum slope possible is
11,5%. Values of the manual wheelchair must be observed for
all of the combinations.
Age of user group:
No restrictions known. Viamobil makes pushing every
wheelchair driver easier by every attendant. Due to the fact
that also many older people are wheelchair users also their
attendants are often older persons.
Physiology:
viamobil products are not used by handicapped persons. The
attending person operating the viamobil is not handicapped.
Author:
Date :
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Clinical Evaluation for
power add-on viamobil V25
Clinical Evaluation
Document:
Page of total:
4 / 17
Change date:
---
Version:
1
2.2 Technical
Conditions of use:
The vehicle is currently tested according to German and
international standards as to their safety. They were also
tested successfully according to EN60529 IPX4 as to their
resistance to spray water, and are therefore well suited for
typical middle European weather conditions. When equipped with
an appropriate lighting system, the vehicles are suitable for
use on public roads. Appropriate environmental conditions
(like climbing ability, max. obstacle height,…) of use are
described in the user manual for every model.
Design:
viamobil V25 is an add-on unit which can be easily mounted to
almost every standard wheel-chair. A small bracket must be
mounted to the frame of the chair to pick up the drive unit.
The control unit of the V25 is either directly attached to
the wheelchair handles or via additional handlebars to the
V25 drive unit.
For transportation purposes or if the manual wheelchair is
needed, the components can be easily dismantled. The heaviest
component does not weight more than 10,3 kg, which makes
transportation simple.
The light product design compared with the powerful motors
makes viamobil very manoeuvrable for indoor and outdoor use
(Class B, EN 12184).
An electric motor in the drive unit is responsible for
propulsion of the viamobil. The steering is done manually by
the attendant like with a manual wheelchair.
Author:
Date :
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Clinical Evaluation for
power add-on viamobil V25
Clinical Evaluation
Document:
Page of total:
5 / 17
Change date:
---
Version:
1
Specifications:
All technical data, such as speed, turning radius, range, safe
climbing ability, maximum obstacle height and permissible
operating conditions can be found in the user manual, chapter
"Technical Data" (chapter 1.6).
Technical Data
Battery pack
Battery charger (input)
Battery charger (output)
Operating voltage
Speed
Motor rating
Climbing capability
Range per single charge
Max. permitted total
weight
Weight of components
Drive unit
Control unit
Battery pack
36V, 6,6 Ah
90 - 240V AC
45V DC
36V
1 - 5,5 km/h
150W
Max. 18%
20 km
210 kg
10,3 kg
0,6 kg
2,3 kg
The add-on units includes:
- Drive unit
- Control unit
- Battery pack
- Battery charger
- Bracket set for drive unit
- Bracket set for control unit or additional handlebars
- User manual
2.3 Biological
Main points addressed are biological compatibility with skin
touching surfaces. Cytotoxicity tests according to ISO 12184
and 10993 have been carried out and successfully passed for
all fabrics and plastics which could get in contact with the
skin during use.
Author:
Date :
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Document:
Clinical Evaluation for
power add-on viamobil V25
Page of total:
6 / 17
Change date:
---
Clinical Evaluation
Version:
1
3. Results from risk assessment
3.1 Potential risks from risk assessment
Risks originate mainly from technical, material, foreseeable
misuse and mechanical characteristics of the product. Basis
for the review was the risk analysis due to DIN EN ISO 14971.
Main points considered are:
Electrical risks:
 Electric shocks
 Malfunction of electronic

Heat and burns
Mechanical risks:
 Squeezing risk
 Risk of sharp components and edges
 Corrosion of metal parts

Breakage of backrest, legrest, armrest, …
Biological risk:
 Toxic components used
Foreseeable not intended use:
 Wrong approach of obstacles
 Breakage of aged product due to missing or incorrect
maintenance
 Use of other chargers
 Use of non authorised parts
 User weight above the defined maximum weight
 Max. slope over the allowed limits
For all the risks mitigation actions were defined and
implemented where the risks were not acceptable to the user.
The potential risk associated with the use of a push and brake
aid is generally significantly lower than the risk associated
with the use of a powered wheelchair or power add-on that is
operated by the handicapped person himself. Viamobil is always
and only operated by the attendant of the wheelchair driver,
thus by persons without handicap.
Author:
Date :
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Clinical Evaluation for
power add-on viamobil V25
Clinical Evaluation
Document:
Page of total:
7 / 17
Change date:
---
Version:
1
3.2 Post market information on claims, complaints and
vigilance reporting
The findings are supported by the report ‘Device Bulletin,
Adverse Incident Reports 2008, DB2009(02), March 2009’. This
medical device adverse incident annual report, published as
Device Bulletin DB 2009(02), provides an overview of medical
device related adverse incidents reported to the MHRA in 2008,
and records recent developments in incident reporting.
Concerning powered mobility the following results were
reported:
Wheelchairs and children’s buggies
Adverse incident reports concerning all types of powered and
non powered wheelchairs used by children and adults decreased
in 2008 by 17% to 703.
Investigations led to many changes in designs and instructions
for use and
11 Medical Device Alerts were issued. MDAs 2008/014, 035, 050,
052,
070, 072 and 077 involved issues concerning the wheelchair
being used as
a seat in a motor vehicle, MDAs 2008/029 and 076 covered
problems with
stability and MDAs 2008/044 and 078 involved failure of the
wheelchair
backrests.
Author:
Date :
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Clinical Evaluation for
power add-on viamobil V25
Clinical Evaluation
Document:
Page of total:
8 / 17
Change date:
---
Version:
1
4. Method
4.1
General
Identification, selection, collection and evaluation are
described for evaluation of the studies.
4.2
Target
The document has the purpose to prove the efficiency and
effectives of powered wheelchairs.
The conformity assessment is done following the requirements
of the Medical Device Directive 93/42/EEC and the update
2007/47/EEC.
Functional tests and user assessment proved the effectiveness
of viamobil V25 as a technical aid that meets the needs of
persons pushing and braking a manual wheelchair.
Experience can also be drawn from the viamobil V10, the first
push and brake aid produced by the Ulrich Alber GmbH from 1996
– 2002, and the viamobil V15 which has been produced from 2002
- 2011. In addition to the long experience in production, use
and reconditioning of this product and other add-on drives
like e-fix and e-motion Alber performs customer surveys on a
regular basis.
All required standards and technical documents for medical
products were applied. The listing of all engineer standards
applied for viamobil V25 can be found in the “norm matrix” of
the Alber Quality Handbook.
Nevertheless, further evaluation is done by a literature
search that is described from chapter 4.3 to chapter 6 of
this Clinical Evaluation.
Due to the fact, that products as a powered wheelchair have
no therapeutic or diagnostic purpose, the application
(mechanism of action) cannot be accessed. Therefore, the
target of the clinical evaluation was to assess:
 The safety of the product
 Technological aspect and
 Possible negative side effects
4.3
Author:
Date :
Identification
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
of
data
Updated by:
Date:
Company
Document:
Clinical Evaluation for
power add-on viamobil V25
Page of total:
9 / 17
Change date:
---
Clinical Evaluation
Version:
1
For the review main focus for the literature search was on
“pier reviewed” articles.
Database used:
 www.pubmed.de and
 www.medline.de
To ensure the medical relevance of the findings.
The key word used for the desk research was: “powered
wheelchair”.
If the search on above mentioned databases had not led to
relevant findings, additional research would have been
performed in the following databases, using the same key word:
 DIMDI: http://www.dimdi.de/static/de/db/index.htm
 Biomed Central: www.biomedcentral.com
 Medpilot. www.medpilot.de
 PEDro (Physiotherapies Evidence Database):
www.Ppedro.org.au
4.4
Data
evaluation
The reviewed documents are evaluated according the internal
ranking system:
Ranking
1
2
3
4
5
6
Description
Intended use, application and technology identical
Intended use, application and technology similar
Intended use, application and technology
comparable
Technology comparable
Eventually comparable
Not comparable
5. Literature search
Find the listing of articles found with the search criteria:
Nr.
Author
1
Subhadra
Evans, Andrew
O. Frank,
Claudius
Neophytou,
Lorraine de
Souza
Author:
Date :
M. Brunner
10.06.2010
Title
Published
Older adults’ use Age and Ageing
of, and
2007; 36: 431–
satisfaction
435
with, electric
powered
indoor/outdoor
wheelchairs
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Remark
Rank
1
Company
Document:
Clinical Evaluation for
power add-on viamobil V25
10 / 17
Change date:
---
Clinical Evaluation
2
3
4
5
6
Nicolas
Vignier, MD;
Jean-François
Ravaud, MD,
PhD; Myriam
Winance, PhD;
FrançoisXavier
Lepoutre, PhD;
Isabelle
Ville, PhD
Anna-Liisa
Salminen,
PhD1, Åse
Brandt, PhD2,
Kersti
Samuelsson,
PhD; Outi
Töytäri, Msc;
Antti
Malmivaara,
PhD
Brad E.
Dicianno, MD;
Sara
Sibenaller,
MS; Claire
Kimmich; Rory
A. Cooper,
PhD; Jay Pyo,
DO
Dan Ding, PhD;
Elizabeth
Leister, MS;
Rory A.
Cooper, PhD;
Rosemarie
Cooper, MPT,
ATP;
Annmarie
Kelleher, MS,
OTR/L, ATP;
Shirley G.
Fitzgerald,
PhD; Michael
L. Boninger,
MD
Michael
Dvorznak, MS;
Author:
Date :
M. Brunner
10.06.2010
Demographics of
wheelchair users
in France:
Results of
national
community-based
handicapsIncapacitésDépendance
surveys
Page of total:
Version:
1
J Rehabil Med
2008; 40: 231–
239
3
Mobility devices
J Rehabil Med
to promote
2009; 41: 697–
activity and
706
participation: A
systematic review
3
Joystick use for
virtual power
wheelchair
driving in
individuals with
tremor: Pilot
study
JRRD, Journal
of
Rehabilitation
Research &
Development
Volume 46,
Number 2, 2009
Pages 269–276
1
Usage of tilt-inspace, recline,
and elevation
seating functions
in natural
environment of
wheelchair users
JRRD, Journal
of
Rehabilitation
Research &
Development
Volume 45,
Number 7, 2008
Pages 973–984
2
Kinematic
analysis for
JRRD, Journal
of
2
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Clinical Evaluation for
power add-on viamobil V25
Clinical Evaluation
Rory Cooper,
PhD; Michael
Boninger, MD
7
Richard C.
Simpson, PhD,
ATP; Edmund F.
LoPresti, PhD;
Rory A.
Cooper, PhD
8
Richard C.
Simpson, PhD,
ATP
Document:
Page of total:
11 / 17
Change date:
---
Rehabilitation
Research &
Development
Volume 42,
Number 3,
Pages 343–352
May/June 2005
How many people
JRRD, Journal
would benefit
of
from a smart
Rehabilitation
wheelchair?
Research &
Development
Volume 45,
Number 1, 2008
Pages 53–72
Smart
JRRD, Journal
wheelchairs: A
of
literature review Rehabilitation
Research &
Development
Volume 42,
Number 4,
Pages 423–436
July/August
2005
Version:
1
determination of
bioequivalence of
a modified
Hybrid III test
dummy and a
wheelchair user
2
2
.
6. Critical Evaluation
6.1
General Comments
Of all abstracts found in the data bases using the key word
“powered wheelchair”, for further evaluation of the viamobil
V25 only the abstracts were used originating from sources
that dealt with similar or identical products. Abstracts
considered relevant had to have the following similarities:
- Intended use (powered wheelchair, ..)
- Usage is similar (powered mobility, similar technology, …)
For the evaluation itself, only abstracts were considered with
a ranking from 1-3. Studies with very view probands (<5
people) were excluded, because of the reduced validity.
Studies in non-English language were
consideration. As the outcome of the
bases was rather limited, and due to
wheelchairs as such have been on the
Author:
Date :
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
not taken into
research in the data
the fact that powered
market for a long time
Updated by:
Date:
Company
Document:
Clinical Evaluation for
power add-on viamobil V25
Page of total:
12 / 17
Change date:
---
Clinical Evaluation
Version:
1
without having to undergo significant changes in the basic
design principles, all otherwise relevant studies published
within the last 30 years have been taken into consideration.
Short summaries of the abstracts and articles taken into
account are presented in the following chapter are presented
in the next part of the evaluations.
6.2 Abstracts/Summaries of relevant articles
Nr. 1
Abstract
Source: Age and
Ageing 2007; 36:
431–435
Remark:
Author(s): Subhadra
Evans, Andrew O.
Frank, Claudius
Neophytou, Lorraine
de Souza
Title: Older adults’
use of, and
satisfaction with,
electric powered
indoor/outdoor
wheelchairs
All but one user said they had been given safety training,
including driving tests and pamphlets. Some users felt
insecure in the chair, especially using kerb climbers.
Three users had accidents and two minor mishaps. No
injuries resulted, but experiences often left users shaken:
‘The state of our pavements and roads, they’re not good,
and quite honestly it shakes me to hell (using the chair
outdoors)’. Sixty-five percent of users felt secure in
their chairs, although this often related to their caution
when in the chair. Weather conditions, crowded pavements,
kerbs and uneven terrain were all avoided. Users
consistently reported concern over batteries and other
people. Battery life was often unknown with the fear that
it would run out leaving the user stranded. The social
environment was another concern with reports that
pedestrians were rarely mindful of the chair. As expressed
by this 64-year-old with arthritis, children were
especially prone to colliding with chairs: ‘Christmas time
is full of people and they all sort of looking up, and mums
and dads are not careful with their children. I’m always
very, very slow and my hand is always out, and I’m always
sort of holding children because parents don’t teach their
children now, how to walk’. Users compensated by moving
slowly through crowds, but stopping suddenly was associated
with risks for users and pedestrians: ‘You’ve got some
button to stop, and you do whack people’s ankles and it
hurts. It’s like a car with stopping distance on it, it’s
not that quick’ (user 13)…
In this article, we explore outdoor activity as a safety
issue for elderly, being concerned about battery capacity
and the use of kerb climbers.
Nr. 2
Abstract
Source: J Rehabil
Med 2008; 40: 231–
239
Remark:
Author(s): Nicolas
Vignier, MD; JeanFrançois Ravaud, MD,
PhD; Myriam Winance,
PhD; François-Xavier
Author:
Date :
M. Brunner
10.06.2010
The HID surveys are the first to have provided national
data on the use of assistive devices in France, and on
wheelchair use in particular. These surveys show that the
population of manual and/or powered wheelchair users in
France can be estimated at 62 persons for 10,000
inhabitants. The prevalence of wheelchair users is thus
lower in France than in other western countries such as UK
(12) (3 times as many users), Canada (6) (1.5 times as many
users among people 12 years old and older living at home)
and the USA (7) (twice as many home users). This more
limited use in France might be due to various factors, such
as a less adapted environment, a historical delay in
developing wheelchair use, and stronger negative social
representations of the wheelchair leading to resistance
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Document:
Clinical Evaluation for
power add-on viamobil V25
13 / 17
Change date:
---
Clinical Evaluation
Lepoutre, PhD;
Isabelle Ville, PhD
Title: Demographics
of wheelchair users
in France: Results
of national
community-based
HandicapsIncapacitésDépendance surveys
Page of total:
Version:
1
from potential users and lower levels of prescription by
healthcare professionals. Further studies will be needed to
more accurately assess the impact of these different
factors. Yet when one examines previous estimates (14, 15)
one can see that even though the prevalence of wheelchair
use in France may be lower than in other countries, it is
increasing strongly, and this change is part of a general
phenomenon that has been documented in several developed
countries…
Also, with regard to marital status, widowhood goes hand in
hand with increased wheelchair use, which might be
interpreted as being an alternative technique to replace
natural helpers. The link between widowhood and life in
institutions already being known (31, 32), the difficulty
in a wheelchair user living alone at home may be one
explanation for the high number of users living in
institutions.
Looking at the majority of the users, ease of use is a
determining factor when choosing a powered wheelchair.
Nr. 3
Abstract
Source: J Rehabil
Med 2009; 41: 697–
706
Remark:
Author(s): AnnaLiisa Salminen,
PhD1, Åse Brandt,
PhD2, Kersti
Samuelsson, PhD;
Outi Töytäri, Msc;
Antti Malmivaara,
PhD
The best study in methodological terms (20, 21) showed that
powered wheelchairs clearly increased activity and
participation as well as quality of life in stroke
patients. Three studies reported adverse effects, i.e.
difficulty in disassembly (26), low accident rate (25) and
slightly increased falls (29). The outcomes are presented
in Table IV.
In this article we learned that stroke patients have a low
accident rate but had difficulties to disassemble the
products.
Title: Mobility
devices to promote
activity and
participation: A
systematic review
Nr. 4
Abstract
Source: JRRD,
Journal of
Rehabilitation
Research &
Development Volume
46, Number 2, 2009
Pages 269–276
Author:
Date :
M. Brunner
10.06.2010
People with disabilities such as multiple sclerosis and
Parkinson’s disease have difficulty operating conventional
movement-sensing joysticks (MSJs) because of varying levels
of tremor. We developed an isometric joystick (IJ) that has
performed as well as a conventional MSJ when used by
persons with upper-limb impairments in real and virtual
wheelchair driving tasks. The Weighted-Frequency Fourier
Linear Combiner (WFLC) filter has been used to cancel
tremor effectively in microsurgery. In this study, we
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Document:
Clinical Evaluation for
power add-on viamobil V25
14 / 17
Change date:
---
Clinical Evaluation
Remark:
Author(s): Brad E.
Dicianno, MD; Sara
Sibenaller, MS;
Claire Kimmich; Rory
A. Cooper, PhD; Jay
Pyo, DO
Page of total:
Version:
1
compared an MSJ, IJ, and IJ with the WFLC filter in
individuals performing a virtual driving task. Although the
WFLC filter did not improve driving performance in this
study, the IJ without a filter yielded better results than
the conventional MSJ and thus may be a potential
alternative to the MSJ in minimizing the effects of tremor.
Hence, individually customized isometric devices may be
superior to commercially available proportional control for
individuals with tremor. The tested joysticks as IJ with
WFLC filter did not improve wheelchair driving as expected.
Title: Joystick use
for virtual power
wheelchair driving
in individuals with
tremor: Pilot study
Nr. 5
Abstract
Source: JRRD,
Journal of
Rehabilitation
Research &
Development Volume
45, Number 7, 2008
Pages 973–984
Remark:
Author(s): Dan Ding,
PhD; Elizabeth
Leister, MS; Rory A.
Cooper, PhD;
Rosemarie Cooper,
MPT, ATP; Annmarie
Kelleher, MS, OTR/L,
ATP; Shirley G.
Fitzgerald, PhD;
Michael L. Boninger,
MD
Title: Usage of
tilt-in-space,
recline, and
Author:
Date :
M. Brunner
10.06.2010
This study examined the usage of powered seating functions,
including tilt-in-space, backrest recline, and seat
elevation, among a group of wheelchair users during their
typical daily activities. Twelve individuals who used a
power wheelchair with seating functions participated in the
study. They drove their own wheelchair and used the seating
functions as needed in their community environment for
about 2 weeks while the seating function usage was recorded
with a portable device. We found that subjects occupied
their wheelchair for 11.8 +/– 3.4 hours a day (all data
shown as mean +/– standard deviation). While occupying
their wheelchairs, they accessed tilt-in-space, backrest
recline, and seat elevation 19 +/– 14 times a day for 64.1%
+/– 36.8%, 12 +/– 8 times for 76.0% +/– 29.8%, and 4 +/– 4
times for 22.5% +/– 34.9%, respectively. Subjects chose to
stay in tilted and reclined positions in their wheelchair
for 39.3% +/– 36.5% of their time each day. They spent
little time in a fully upright position. Subjects changed
their seating positions every 53.6 +/– 47.0 minutes. Time
spent in positions of different seating pressures varied
among subjects. The information collected could enhance
clinical practice of wheelchair provision, resulting in
better compliance with clinical instructions and
appropriate use of seating functions among wheelchair
users.
The study showed that subjects consistently accessed the
seating functions throughout the day and spent most of
their time in tilted and/or reclined positions; however,
most did not reposition themselves as frequently as
recommended in the clinical practice guideline.
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Document:
Clinical Evaluation for
power add-on viamobil V25
Page of total:
15 / 17
Change date:
---
Clinical Evaluation
Version:
1
elevation seating
functions in natural
environment of
wheelchair users
Nr. 6
Abstract
Source: JRRD,
Journal of
Rehabilitation
Research &
Development Volume
42, Number 3, Pages
343–352 May/June
2005
Remark:
Author(s): Michael
Dvorznak, MS; Rory
Cooper, PhD; Michael
Boninger, MD
Title: Kinematic
analysis for
determination of
bio-equivalence of a
modified Hybrid III
test dummy and a
wheelchair user
We investigated whether a modified 50th-percentile Hybrid
III test dummy (HTD) (First Technology Safety Systems,
Plymouth, MI) would have motion similar to a wheelchair
test pilot (TP) with T8 paraplegia. Test cases were seated
in a Quickie P100 electrically powered wheelchair (Sunrise
Medical, Inc., Phoenix, AZ) driven at three speeds (0.8,
1.4, and 2.0 m/s). Three braking conditions—joystick
release, joystick full reverse, and emergency power-off—
were used to stop the wheelchair. The subsequent upper-body
motion was recorded for the creation of kinematic exposure
profiles of the wheelchair riders. The maximum
concentration (Cmax) and area under the trunk angular
displacement, velocity, and acceleration curves (AUC0–Cmax)
were calculated. Assessments of average, individual, and
population bioequivalence were conducted after data were
subjected to natural logarithmic transforms. Only the Cmax
of the trunk angular acceleration of the HTD and TP was
average bioequivalent (0.82–1.04). Both Cmax and AUC0–Cmax
measures for all kinematic exposures between the TP and HTD
were individual and population bioequivalent (95% upperconfidence bound < 0, linearized bioequivalence criteria).
This indicates that the HTD is a suitable surrogate for a
wheelchair user in low-speed, low-impact wheelchair
studies.
The conclusions of this study are mixed, depending on the
BE criterion used. ABE methods would tend to indicate that
further modifications would be necessary to the HTD for
accurate assessment of wheelchair user kinematics during
tips and falls.
Nr. 7
Abstract
Source: JRRD,
Journal of
Rehabilitation
Research &
Development Volume
45, Number 1, 2008
Pages 53–72
Remark:
Author(s): Richard
C. Simpson, PhD,
ATP; Edmund F.
LoPresti, PhD; Rory
A. Cooper, PhD
Title: How many
people would benefit
Author:
Date :
M. Brunner
10.06.2010
Independent mobility is important, but some wheelchair
users find operating existing manual or powered wheelchairs
difficult or impossible. Challenges to safe, independent
wheelchair use can result from various overlapping
physical, perceptual, or cognitive symptoms of diagnoses
such as spinal cord injury, cerebrovascular accident,
multiple sclerosis, amyotrophic lateral sclerosis, and
cerebral palsy. Persons with different symptom combinations
can benefit from different types of assistance from a smart
wheelchair and different wheelchair form factors. The sizes
of these user populations have been estimated based on
published estimates of the number of individuals with each
of several diseases who (1) also need a wheeled mobility
device and (2) have specific symptoms that could interfere
with mobility device use.
An estimated 2.3 million people aged 15 and older used a
wheelchair or electric scooter in 1999 [104]. The projected
population of smart powered wheelchair users of 1.4 to 2.1
million represents 61 to 91 percent of all wheelchair
users. This projection does not mean, of course, that 61 to
91 percent of wheelchair users need a smart wheelchair all
the time. It simply means that 61 to 91 percent of
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Document:
Clinical Evaluation for
power add-on viamobil V25
16 / 17
Change date:
---
Clinical Evaluation
from a smart
wheelchair?
Page of total:
Version:
1
individuals would benefit from a smart wheelchair at least
some of the time. The number of wheelchair users has grown
at an average annual rate of 5.9 percent a year [104]. At
that rate, by 2010, wheelchair users will increase to 4.3
million, with 2.6 million to 3.9 million of these users
benefitting from a smart wheelchair. Much like cruise
control or Global Positioning Systems in automobiles, which
people use a fraction of the time they are driving, the
capabilities of a smart wheelchair may initially be sold as
a luxury for high-end wheelchairs and slowly move toward
greater market penetration.
Nr. 8
Abstract
Source: JRRD,
Journal of
Rehabilitation
Research &
Development Volume
42, Number 4, Pages
423–436
July/August 2005
Remark:
Author(s): Richard
C. Simpson, PhD, ATP
Title: Smart
wheelchairs: A
literature review
Several studies have shown that both children and adults
benefit substantially from access to a means of independent
mobility. While the needs of many individuals with
disabilities can be satisfied with traditional manual or
powered wheelchairs, a segment of the disabled community
finds it difficult or impossible to use wheelchairs
independently. To accommodate this population, researchers
have used technologies originally developed for mobile
robots to create “smart wheelchairs.” Smart wheelchairs
have been the subject of research since the early 1980s and
have been developed on four continents. This article
presents a summary of the current state of the art and
directions for future research.
Clinicians indicated that 9 to 10 percent of patients who
receive power wheelchair training find it extremely
difficult or impossible to use the wheelchair for ADL. When
asked specifically about steering and maneuvering tasks,
the percentage of patients who reported these tasks
difficult or impossible jumped to 40 percent. Eighty-five
percent of responding clinicians reported seeing some
number of patients each year who cannot use a power
wheelchair because they lack the requisite motor skills,
strength, or visual acuity. Of these clinicians, 32 percent
(27% of all respondents) reported seeing at least as many
patients who cannot use a power wheelchair as who can.
Nearly half of patients unable to control a power
wheelchair by conventional methods would benefit from an
automated navigation system according to the clinicians who
treat them.
6.3 Product Literature and Instructions for Use
We found our product literature and operating instruction to
be consistent with the clinical data, covering all hazards
and other clinically relevant information that might have an
impact on the use of the viamobil V25.
7. Conclusions
Author:
Date :
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date:
Company
Clinical Evaluation for
power add-on viamobil V25
Clinical Evaluation
Document:
Page of total:
17 / 17
Change date:
---
Version:
1
According to all tests performed and all literature
evaluated, push and brake aids as the viamobil V25 bear
neither additional positive therapeutical side effects nor
risks for their users . The quotations highlight:
 the clinical evidence demonstrates conformity with
relevant Essential Principles;
 the performance and safety of the device as claimed have
been established;
 the risks associated with the use of the device are
acceptable when weighed against the benefits to the
patient and user; and
 the risk associated with the use of a push and brake aid
is to be regarded as significantly lower then the risk
associated with the use of a power wheelchair or power
add-on which is used by the wheelchair driver himself.
The viamobil is always used by the attendant of the
wheelchair driver thus an assisting person is always
present.
(To support the understanding the positive aspects are
highlighted in green and the negative aspects in red)
As a central remark, it has to be kept in mind that the
purpose of the product was not to create a therapeutical
benefit, neither has its design a diagnostic purpose.
The devices evaluated in this study were designed for
attendants of persons whose ability to walk is impaired. Using
a push and brake aid lightens the load for the attendant and
allows pushing and braking a wheelchair more easily and
safely. By this the wheelchair driver is enabled to
participate in the community’s day-to-day life better. As the
wheelchair driver does not use a push and brake aid by
himself, it would have been a surprise if any therapeutical
benefit had been found in the course of this clinical
evaluation.
Author:
Date :
M. Brunner
10.06.2010
Checked:
Date :
C. Hauschel
14.06.2010
Updated by:
Date: