Vendlet BASIC Manuale utente

VALUE IN CARING
MANUAL
BASIC

We, Vendlet ApS hereby declare that the devices menoned below comply with the
Medical Device Regulaon (EU) 2017/745.
Legal manufacturer Vendlet ApS, Egelund 33, 6200 Aabenraa, DK
Product Product no. and name
VENDLET Basic
UDI-DI:
05714038001056
Designaon VENDLET Basic is an electromechanical turning aid.
Classicaon, rule Class I acc. to rule 1 and 13 of annex VIII in (EU)
2017/745.
The product is tested
according to the standard
EN 60601-2-52:2010 Medical electrical equipment –
Part 2-52: Parcular requirements for basic safety and
essenal performance of medical beds
This declaraon of conformity is valid from the date of signature.
Aabenraa, 23.05.2019
Peter Maindal
Director

Congratulaons on your new VENDLET.
The VENDLET is used for handling bedridden clients, for
example:
• turning to lateral, prone or supine posions
• moving from one side of the bed to the other
• reposioning the client up in the bed
• transferring the client from one bed to another
This manual covers the VENDLET Basic.
Max. user weight is 150 kg
The instrucons in this manual must be followed. Vendlet
ApS shall not be liable should the VENDLET Basic be used,
modied, or assembled in a way that is not described in this
manual.
This manual is divided into three parts:
Part 1 contains general informaon that is useful to everyone
responsible for the purchasing, examinaon, use, assembly,
and maintenance of the VENDLET Basic.
Part 2 is a user manual containing informaon about the
operaon and daily maintenance of the VENDLET Basic.
Part 3 is a technical manual containing informaon about the
assembly, maintenance, and service of the VENDLET Basic.

Prone posion 15
Side rail 16
Aaching the turning sheet before use 18
What should I do if the turning sheet is rolled askew on the bars? 18
Cleaning of electric and mechanical parts 21
Washing instrucons, slide sheet 21
Washing instrucons, turning sheet w. quick tag 21
Turning 11
Moving from one side of the bed to the other 12
Reposioning the client up in the bed 13
Applying a sling 14

Tools 24
Overview of bolts 24
Dimensional requirements, side rails 24
Maximum loads 25
Aaching a side 25
Height adjustment 26
Mounng the control unit 27
Connecon of power cables 28
Connecng the control unit 28
Mechanical parts 30
Sheets 30
Funconal tests 30
Electrical parts 30
Recharging during storage: 32

PART 1 - General information
6
VENDLET Basic may be used for moving clients to a lateral,
prone, or supine posion, from one side of the bed to the
other, or, to reposion them further up in bed.
VENDLET Basic protects the caregiver from physical strain
and heavy liing in connecon with the handling of immobile
clients. Clients are turned/handled by pressing a hand control
whereby the caregiver may support a client and ensure their
correct and comfortable posioning. This provides room for
increased awareness in the care, which boosts employee job
sasfacon and client well-being.
To the client, the turning process becomes uniform and
steady as the sheet supports the body over its full length.
The target group is adult clients who are being cared for,
dressed, washed etc. in bed. This will oen be clients who
are lied in and out of bed or clients who are mobilized using
a standing aid. Hence, the user will typically be clients with
few physical and/or cognive resources and palliave clients.
VENDLET Basic is also suitable for clients at risk of developing
pressure ulcers in that the uniform and steady transfer in the
sheet minimizes fricon and the associated shear that can
damage the ssue and cause pressure ulcers. Furthermore,
the VENDLET is oen seen to have a posive eect on clients
suering from spaal awareness.
The VENDLET Basic is intended for adult clients weighing be-
tween 40 and 150 kg, with a height above 146 cm and a body
mass index (BMI) above 17.
Prior to the rst use of the VENDLET, it is important to assess
whether the VENDLET is suitable for the client in queson. It
may be necessary to take special precauons, for example if
a client is very restless in bed or has an untypical anatomy.
VENDLET Basic is not designed to be operated by the clients
themselves. However, if a risk assessment made by the re-
sponsable healthcare professional evaluate, that the client is
able to take part in the moving and handling procedures, e.g.
by operang the hand control, it can be a part of the rehabil-
itave eort.
The risk assessment should evaluate the clients physical, cog-
nive and palliave resources. The risk assessment must be
available by the bed and must be updated on a regular basis.
Vendlet cannot be held responsible for the risk assessment
or conclusions based on this.
Before using VENDLET Basic, it must be ensured that the
care givers have been trained in proper use of the VENDLET
system.
Environment
VENDLET Basic can be used in applicaon environment 1-5,
e.g. hospitals, nursing homes and domesc / private homes.
VENDLET Basic and rehabilitaon
It is not the intenon to pacify the client with the VENDLET
system. Therefore, you should always use the resources of
the client. For example, if the client can move his/her arm to
the side, he or she should do so. You should also consider let-
ng the client operate the hand control and thereby involve
him/her in the process if this is feasible.
Operang the hand control by the client requires a risk as-
sessment made by the responsible healthcare professional.
VENDLET Basic consist of two bars ed with motors. The
bar on the le side of the client has a blue color marking and
the bar on the right side of the client has a red color marking.
Each motorized bar has a groove which makes it possible to
aach the edge strip of the turning sheet to the bars. When
bars are running, the turning sheet will be dragged between
the two bars, making it possible to move it from side to side.
A slide sheet is inserted under the turning sheet in order to
reduce the fricon of the turning sheet against the maress.
The bars are raised manually by liing the bar unl the cor-
ner post clicks leaving the bar locked in the upper posion.
The bar can be raised one end at the me or simultaneously
by a grip on the middle of the bar.
The bars are lowered manually by liing the end of the bar
while clicking the grey buon at the top of the corner post.
This releases the bar which can now be lowered.
Furthermore, the VENDLET consist of a control unit and a
hand control. The control unit is placed underneath the bed,
normally on the base frame.
When the bars are raised VENDLET Basic works as side rails.
VENDLET Basic is telescopic in length and can be extended
from 201 to 221 cm.

PART 1 - General information
7
Red corner post
Head end
Red corner post
Foot end
Blue corner post
Head end
Blue corner post
Foot end
Turning sheet
Blue bar
Red bar
VENDLET Basic
VENDLET Basic is switched on by double-clicking the on
the hand control. VENDLET Basic produce a “beep” upon
acvaon and the green diode over the power symbol turns
on.
When VENDLET Basic hasn’t been used for 90 seconds, the
system produces a “beep-beep” sound, the diode turns o,
and then VENDLET Basic is turned o.
When VENDLET Basic has been turned on, the bars can be
turned in both direcons. The colour coding on the bars
relates to the colours on the hand control buons.
Press and hold the individual buons long enough to obtain
the desired operaon; the motors will stop when the buon
is released. Likewise, you may stop an acvated funcon by
clicking the .
Tighten the sheet
on the blue bar
Slacken the sheet
on the blue bar
Tighten the sheet
on the red bar
Slacken the sheet
on the red bar
Power with
light / stop buon
VENDLET Basic hand control
The bars on the VENDLET Basic turn together. If the red bar
pulls, the blue bar starts slackening, and vice versa. If you
don’t want the sheet to be slackened at the opposite bar,
press both + simultaneously or + simultaneously.
Roll the sheet on
the red bar without
slackening the sheet
on the blue bar by
pressing +
simultaneously
Roll the sheet on
the blue bar without
slackening the sheet
on the red bar by
pressing +
simultaneously

PART 1 - General information
8
When the bar is up on the side where the turning sheet is
being ghtened, the client will be turned. If, on the other
hand, the bar is down on the side where the turning sheet is
being ghtened, the client will be moved towards the edge
of the bed. These fundamental principles provide you with
a number of ways to move and/or transfer clients. See the
“How to Use the VENDLET” secon in Part 2 – User Manual
for further details.
VENDLET Basic can be operated by only one carer.
As it is recommended that the clients does not
operate the VENDLET themselves, the hand
control must be placed on the outside of the bed
before leaving the client.
The client must not operate VENDLET Basic on
their own unless a qualied risk assessment has
been carried out. Vendlet ApS cannot be held
responsible for the risk assesment or conclusions
based on this.
Always, keep focus on the client when using
VENDLET Basic.
If the client has long and loose hanging hair, the
hair could in some situaons be rolled onto the
bar. Therefore, long loose hair should be collect-
ed before moving and handling the client.
Be aware, that the client does not get too close
to the edge of the bed, as there is a risk of falling
out of the bed.
Do not use VENDLET Basic if the bars can not be
elevated properly.
The power buon also funcons as a stop
buon.
If the hand control buon controlling the ght-
ening of the sheet fails, the operaon can be
stopped by pressing the buon.
Addional hand control:
An addional hand control can be connected if a hand con-
trol is required on both sides of the bed.
Wider sheets:
Wider turning sheets and slide sheets are also available if the
VENDLET is to be used on wider beds.
Baery backup:
Addionally, a baery backup is available to operate VEND-
LET Basic without a connecon to the supply network. See
page 32 for technical informaon on the baery backup.

PART 1 - General information
9
VENDLET Basic is intended for mounng on a wide range of
hospital and care beds and with a wide range of maresses.
The following bed and maress requirements must be met.
The bed must meet the EN 60601-2-52 standard or the ex-
pired EN 1970 or EN 60601-2-38 standards.
The bed must have a square steel frame (dimensions H 45-78
mm, W min. 20 mm, L min. 1840 mm without protrusions).
Inner distance between the head- and foot board must be
at least 201 cm. The bed width is not crucial as extra wide
turning sheets and slide sheets are available.
VENDLET Basic can be mounted on most beds with these
dimensions. But situaons where VENDLET Basic cannot be
mounted can occur.
The maximum user weight and safe working load
requirements of the bed manufacturer must not
be exceeded following the installaon of VEND-
LET Basic.
The maress must meet the bed manufacturers
requirements and be suitable for the bed.
The maximum user weight specicaon of the maress must
not be exceeded.
Following the mounng of the VENDLET Basic, the distance
between the maress sides and side rails must be minimum
2.5 cm and maximum 4 cm, see page 24.
If the maress is so and easily compressible, it must be
ensured that there is no entrapment hazard due to extra
compression at the edge of the maress.
When alternang air maresses are used, it should be possi-
ble to inate the maress to a rm state before the VENDLET
is operated. So maresses will increase the fricon against
the maress and create an uneven base for the client which
will be uncomfortable for the client when the VENDLET sys-
tem is operated.
If the client changes maress, the VENDLET
installaon must be evaluated. A new maress
might change the condions and necessitate the
reinstallaon of the VENDLET system to reduce
the risk of entrapment.
Vendlet ApS provides a 1-year factory warranty on all electric
parts. Opening the control unit or the hand control will void
the warranty.
Vendlet ApS provides a 3-year warranty on all mechanical
parts (except the sheets).
The VENDLET Basic service life is 5 years. The service life may
be signicantly extended if the product is used and handled
with care and maintained in accordance with the guidelines
in this manual.
The VENDLET Basic must be serviced by a qualied techni-
cian annually, see page 30.
In case of an adverse event or a near-accident involving
VENDLET Basic, the accident must be reported to the compe-
tent authority in the country in which the accident happened
and to the Danish Health and Medicines Authority.
Likewise, Vendlet ApS must also be informed on phone
+45 9631 0050 or vendlet@vendlet.dk.

PART 1 - General information
10
CE marking: The product complies with the Medical Device Regulaon (EU) 2017/745
MD This product is a medical device
Legal manufacturer
Date of manufacture
Serial number
Item no. / Catalogue number: 7 digits
Operang instrucons
Warning triangle indicates when special aenon is necessary
For indoor use
This product is a class ll equipment (IEC 61140)
The product is a type B equipment according to EN 60601-1
Max. user weight
Electronic scrap. When disposing of the products, sub-components should be recycled
IPX 6 This product is washable
0
+50
This product must be stored between 0 and + 50° C
20
90%
This product must be stored between 20 and 90 % humidity at 30° C
Keep dry (when stored)
Rev. Revision no. of the label
Power / stop buon
Tighten the sheet on the red or blue bar
Slacken the sheet on the red or blue bar
The component contains a thermal fuse
The component complies with the Australien EMC regulaon.
China RoHS
The component contains a safety isolaon transformer
Type + item Product no/catalogue no
Max load Push force for actuator in Newton
Power Rate Max power supply 24 V DC or AC
U In
I In
U In = Voltage used
I in = Current used
Date Date of producon
Duty cycle/
Int 10%, 2 min use and 18 min rest
W/O Work order
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