Vendlet BASIC User manual
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
PART 2 - User manual
11
The turning sheet on VENDLET Basic can only be operated
with the hand control. The turning motors lock in posion
when not used.
The bars are raised and lowered manually.
During operaon, the bars must always be
horizontal in the highest or lowest posion.
Remember to slacken the turning sheet by pressing the
or buon before raising the bar.
Should the turning sheet be too loose on one side, you can
ghten the sheet by pressing + simultaneously or
+ simultaneously.
Turning
VENDLET Basic may be used to turn clients. Follow this
procedure to move a client from a supine posion to lying on
his/her right side.
1. Turn VENDLET Basic on by double clicking the buon.
Press the buon to slacken the turning sheet.
7. The client now lies on his/her right side.
8. Press the and buon to slacken the sheet before
the client is le unaended in the bed.
The red bar does not necessarily have to be raised. But if this
makes the client or the care giver feel more safe, the red bar
could be raised during the process.
4. Place the le arm of the client on his/her stomach or
chest the moment before he/she starts turning.
6. Then shi the le leg in parallel above the right leg.
2. Raise the blue bar by liing unl it locks in both corner
posts.
3. Press the buon to ghten the turning sheet on
the blue bar.
5. Immediately aer this, guide the right arm of the client
to the side.
PART 2 - User manual
12
Moving from one side of the bed to the other
VENDLET Basic may also be used to move clients to the side
of the bed.
In many situaons, this will give the care giver a beer work
posture, for example in connecon with examinaons, train-
ing, care tasks, dressing, etc.
Moving the client to the edge also improves the contact with
the client.
2. Do the same at the foot end.
3. Turn VENDLET Basic on by double clicking the buon.
4. Press the or buon on the hand control to drag
the client to the side towards you.
5. When your work is done, press the or buon to
reposion the client in the middle of the bed.
1. Lower the bars if they are raised: Li the bar and press
the grey buon on the corner post. When it is released
you can lower the head end of the bar.
6. Press the and buon to slacken the sheet before
the client is le unaended in the bed.
PART 2 - User manual
13
Reposioning the client up in the bed
It is a well-known problem that clients oen slide down to
the foot end, for example when the back support has been
raised – even if the knee break on the bed was acvated
before the back support.
Typically, when a client slides towards the foot end, the turn-
ing sheet follows the body of the client. In such situaons,
you may use VENDLET Basic to move the client up in the bed
again.
Work in a zig zag paern moving the client diagonally from
side to side of the bed pulling the turning sheet on to the bar,
whilst guiding the sheet to the upper end of the bar.
1. Lower the bars if they are raised.
2. Turn VENDLET Basic on by double clicking the buon.
3. Stand next to the headboard and press the buon to
slacken the turning sheet on the blue bar to allow you
to roll the turning sheet back on to the blue bar on the
upper end.
4. Gently guide the turning sheet to the upper end of the
blue bar while pressing the buon to pull the client
to the side of the bed.
5. Stop when the client reaches the side of the bed and
repeat the procedure on the opposite side.
6. Connue this process unl the client has been reposi-
oned up in the bed.
7. Press the and buon to slacken the sheet before
the client is le unaended in the bed.
PART 2 - User manual
14
Applying a sling
It is easy to apply a sling on the client when VENDLET Basic is
used.
1. Turn VENDLET Basic on by double clicking the buon.
2. Use the turning funcon of the VENDLET system to move
the client onto his/her side.
3. Place the sling along the back of the client and make
sure that the sling is centered and correctly placed in ac-
cordance with the instrucons of the sling manufacturer.
4. Use the VENDLET turning funcon to move the client
onto his/her back again.
5. Free the straps on the opposite side.
6. Place all straps in such a way that they are ready to be
placed on the liing beam of the hoist.
PART 2 - User manual
15
Prone posion
VENDLET Basic can also be used to turn a client to a prone
posion.
1. Place the clients right arm closely along his/her body
with the palm of the hand facing the hip. Move the pil-
low and place it close to the right upper arm so that the
client comes to lie with his chest on top of the pillow.
2. Turn VENDLET Basic on by double clicking the buon.
Press the buon to slacken the turning sheet.
3. Raise the blue bar by liing unl it locks in both corner
posts.
4. Press the buon to wind the turning sheet onto the
blue bar. The VENDLET system now turns the client. Hold
your hands on the client’s shoulder and hip to provide a
sense of safety during the procedure. Gently support the
client as he/she is being turned to prone posion.
5. Check that the clients head is comfortable and that there
is room for breathing.
6. To return to a supine posion, raise the red bar and
press the buon to wind the turning sheet onto the
red bar. The VENDLET now turns the client to supine
posion.
7. Press the and buons to slacken the sheet before
the client is le unaended in the bed.
PART 2 - User manual
16
Side rail
If it is assessed that the client must use side rails, VENDLET
Basic has integrated side rails.
1. Press the and buons to slacken the turning
sheet. Raise the bars by liing unl it locks in both cor-
ner posts
2. Press the and buons to slacken the sheet before
the client is le unaended in the bed.
3. Should the turning sheet be too loose on one side, you
can ghten the sheet by pressing + simultane-
ously or + simultaneously.
See page 24 for further informaon on side rail dimensions.
VENDLET Basic does not interfere with the funconality of
the bed. Slacken the turning sheet suciently before raising
the back, thigh, and/or foot part of the bed.
Under normal circumstances, the bed surface must be level
before you use the VENDLET.
In some situaons, however, it may be advantageous to use
the back or foot part of the bed when moving or turning
clients. For example, if the client has wide hips and frail
shoulders, he/she will rest more comfortably on the bed if
the head and foot parts are raised a lile before the process.
VENDLET Basic does not reduce the eect of either pres-
sure-relieving maresses or alternang air maresses. We
have performed pressure measurements which unambigu-
ously show that VENDLET Basic does not have a negave im-
pact on the pressure-relieving properes of the maresses.
To prevent interference with the funcon of alternang air
maresses, the turning sheet must be suciently slackened
before a client is le unaended in the bed.
At the same me, the velcro strap on the slide sheet must
not be fastened too ghtly on to the steel frame under the
maress.
We recommend that alternang air maresses are rmly
inated before paent handling as this brings higher comfort
to the client during the process.
VENDLET Basic can also be used for clients using incon-
nence sheets. The inconnence sheet should have a min-
imum width of 125 cm so that it can follow the client’s
movements during turning. You should not use two small
inconnence sheets as the client in this case will lie on a
double edge, which increases the risk of developing pressure
ulcers.
The inconnence sheet must not be wrapped around the
bars, but instead must hang loosely out over the bars.
If the client has a catheter or a drainage tube, it may be nec-
essary to adjust the tubes, etc. individually.
Placing the urine bag or drainage tube at the foot end will
oen be an opmal soluon. Should this not be possible,
however, you could use long tubes to hang the urine bag or
drainage bag on the outer surface of the VENDLET system.
In such cases, the bag should be placed on the bed frame by
the footboard and the tube routed between the footboard
and the VENDLET bracket. Be careful to avoid squeezing the
tube.
PART 2 - User manual
17
Place a slide sheet directly on top of the maress, followed
by the turning sheet which is then aached to the two bars.
Slide sheets and turning sheets are available for standard bed
sizes and oponally with increased width which makes the
VENDLET systems suitable for wider beds as well.
Slide sheet width Fits maress widths
95 cm (standard) 80 - 90 cm
115 cm 95 - 110 cm
135 cm 110 - 130 cm
Turning sheet width Fits maress widths
270 cm (standard) 80 - 100 cm
320 cm 100 - 130 cm
1. Fold the slide sheet corner elasc straps around the mat-
tress. Check that the surface is smooth and even without
creases and folds. Make sure that the slippery side is
facing upwards.
2. Fasten the velcro straps around the maress support
frame.
It is important that the straps are fastened around the frame
under the maress and not around the bed frame as this will
prevent the back, thigh, and foot parts of the bed from being
raised. The straps are long enough for thick maresses.
The slide sheet is subject to extensive wear and must be
checked regularly. The fricon of the turning sheet against
the maress will increase and the comfort of the client will
be reduced during moving and other forms of handling if the
bed is not ed with a slide sheet or the slide sheet has been
damaged.
When an alternang air maress is ed with a slide sheet,
it is important that the velcro straps are not fastened too
ghtly around the frame under the maress as this could
disrupt the funcon of the alternang air maress. Conse-
quently, the maress should be fully inated while ng the
slide sheet.
PART 2 - User manual
18
Aaching the turning sheet before use
What should I do if the turning sheet is rolled askew on the
bars?
Occasionally, the turning sheet will roll askew on the bars. As
such, this is insignicant and the VENDLET system will sll be
operable.
This could result in creases in the turning sheet under the
client which is undesirable. Hence, we recommend that you
aim to smooth the turning sheet if the sheet is askew by
more than a hand’s width on the bars.
In this situaon, you will have to slacken the sheet that
has been pulled askew and pull it in again while guiding /
smoothing it with your hand.
1. Place the turning sheet in the middle of the bed
2. Press the edge strip of the turning sheet into the groove
on one of the bars; begin at the head end of the bed and
work your way down to the foot end.
3. The turning sheet must always be placed OVER the bars
to prevent ngers, hair etc. of the client from geng
caught under the sheet. If the sheet is placed under the
bars, the pulling power will be reduced and the motors
will switch o when the turning sheet is pulled in by the
bar.
4. Press the or buon on the hand control and
allow approx. two-thirds of the sheet to be pulled in by
the bar.
5. Press the edge strip at the opposite edge of the turning
sheet into the groove on the other bar.
6. Use this bar to pull in the turning sheet by pressing the
or , buon unl the sheet covers the maress
evenly with the red line at the centre of the maress.
7. 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 oppo-
site bar, press both + simultaneously or +
simultaneously.
PART 2 - User manual
19
Changing the turning sheet on an occupied bed
1. Posion the client on his/her side and then move him/
her to the centre of the bed.
Evacuaon of persons with VENDLET Basic mounted should hap-
pen via the end of the bed, or via the side of the bed.
1. Remove the footboard.
2. Cut the turning sheet between the maress and the bar.
3. Evacuate the client via the end of the bed.
In case you have power:
1. Lower the bar on the evacuaon side.
2. Use the VENDLET to pull the client to the side of the bed and
evacuate.
In case you do not have power:
1. Lower the bar on the evacuaon side.
2. Cut the turning sheet between maress and the bar.
Pull the bed occupant to the side of the bed and evacuate.
2. Remove the old turning sheet from the bar facing the
back of the client and fold the sheet in layers or roll it.
Tuck it underneath the client.
6. Remove the old turning sheet and aach the replace-
ment sheet to the bar.
4. Allow approx. half of the new turning sheet to roll onto
the bar and stop when the red line on the sheet is at the
centre of the maress. Fold the remaining part of the
new turning sheet in layers or roll it. Tuck it under the
turning sheet being replaced.
3. Aach the new turning sheet to the bar and press or
buon to roll the new turning sheet onto the bar.
5. Use the opposite bar to move the client to a supine posi-
on on top of the new and the old turning sheets.
PART 2 - User manual
20
VENDLET Basic is a reusable medical device intended for
long-term use, requiring safe procedures in connecon with
cleaning and maintenance as well.
VENDLET Basic must be checked daily in accordance with the
checklist below. If a ”Yes” checkbox is marked, this indicates
a desired result. If a ”No” checkbox is marked, this indicates a
risk in which case the VENDLET system must not be used.
In case of malfuncons, faults, missing parts, or improper t-
ng, contact a qualied technician for an inspecon or repair.
1 Is VENDLET Basic free from visible damage and crooked brackets and ngs? Yes No
2 Does the bars lock in both corner posts, when the bars are lied? Yes No
3 Are the nylon straps aached to the bed frame and all the support bars? Yes No
4 Is the condion of the turning sheet sound and does the sheet run over the bars? Yes No
5 Is the slide sheet fastened around the frame under the maress and in good condion? Is the slippery side facing upwards? Yes No
6Double-click the on the hand control. Does the green diode on the hand control illuminate?
Does everything work when you press the matching hand control buons?
Yes No
7 Has it been veried that the condion of the client and the maress/bed/client combinaon have not changed relave to
when VENDLET Basic was mounted?
Yes No
8 Are the care givers familiar with the instrucons of this manual and have they received training in the use of VENDLET Basic? Yes No
9 Is the quick guide located at an easily accessible spot near the bed? Yes No
10 Has it been veried that the date of the next annual inspecon has not come and gone? Yes No
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