Rebotec Verona User manual

REBOTEC®Rehabilitationsmittel GmbH
DE-49610 Quakenbrück, Artlandstr. 57- 59
Telephone: [phone]
Fax: [phone]
Web: www.rebotec.de
BA-Nr.: 02.08.076/2021-01-A01 Email: [e-mail]
Read this User Manual before using the device for the first time and keep it at hand for the
user as well as for future use and subsequent sales.
EN
User Manual
Shower stool
Figure similar
Verona
368.00.30
175 kg

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Table of contents
1. Product description .......................3
1.1. Introduction ............................................3
2. Features ..........................................3
2.1. Intended purpose ...................................3
2.2. Conditions of use...................................3
2.3. Storage & transport................................3
2.4. Equipment & functions..........................3
2.5. Packaging ...............................................3
2.6. Disposal ..................................................3
3. Symbols & nameplates..................4
4. Safety instructions.........................4
5. Incident reporting...........................5
6. Warranty..........................................5
6.1. Complaint................................................5
7. Reuse, lifetime................................5
8. Scope of delivery............................5
9. Setting up for use...........................5
9.1. Assembling the tube sets......................5
9.2. Adjusting the seat height ......................6
10. Product data ...................................6
11. Operation of the product ...............6
11.1. Sitting down............................................6
11.2. Getting up ...............................................6
12. Care and maintenance...................6
12.1. Cleaning and care ..................................6
12.2. Maintenance............................................7
13. Spare parts & accessories.............7
14. Drawing & dimensions...................8

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1. Product description
Figure shows:
A
Seat plate
B
Plug
C
Tube set
D
Tube holder with union nut
E
Adjustment clip
F
Foot cap
G
Guide bush
H
End plug
I
Nameplate
1.1.Introduction
•The product described here is a medical device of
risk class I according to (EU) 2017/745 MDR.
•In this user manual, you will find information on the
safe and proper initial operation, use, maintenance
and care of this product.
•Carefully read this user manual before using the
device. Follow the safety instructions and act ac-
cordingly.
2. Features
2.1.Intended purpose
•The product is intended for the care of patients
with limited ability to stand. It allows you to shower
while sitting down. The patient must have sufficient
sitting ability and upper body musculature. If nec-
essary, a nurse must be present during use. The
product is not intended for prolonged sitting.
Specification:
•Maximum user weight: 175kg
•Stool
•Indoor use
Indication
•If it is impossible for patients to safely stand in the
shower, due to damage to the function of the lower
extremities with limited or eliminated mobility and
muscle strength and/or damage to the vestibular
functions or tendency to fall due to other causes,
while at the same time maintaining a sufficiently
stable thorax posture for sitting and sufficient re-
sidual functions of the upper extremities.
•Objective: Enabling independent or more inde-
pendent showering.
Example diagnoses:
•The spectrum of possible diagnoses is extensive.
It ranges from general old age weakness to arthro-
sis of the lower extremities.
2.2.Conditions of use
•Temperature range: 10°C to +40°C; direct radiant
heat on the product must be avoided.
•Relative humidity: 20%-60%. Outside of these
conditions, the product must only be used for a
short time.
•The product is not suitable for use in swimming
pools or saunas, as surface discolouration and lim-
itations of mechanical strength may occur.
•Disassembly for transport or storage is possible.
•There must be a flat surface of sufficient size for
the stool to be placed on. See 14.
2.3.Storage & transport
•Temperature range: 0° C to +40° C; direct radiant
heat on the product must be avoided.
•Store the product in dry rooms with a humidity of
20-55%.
2.4.Equipment & functions
•Can be height-adjusted to 7 positions
2.5.Packaging
•We recommend you keep the packaging for a later
transport.
•Dimensions: 425mm x 425mm x 150mm
2.6.Disposal
•Disposal and recycling of used products and pack-
aging must be carried out in accordance with cur-
rently valid regulations. Please contact a disposal
company for further information.
•The Infection Protection Act must be observed.
•Please observe any labels and information on
packaging material and act accordingly.
A
B
C
D
F
E
G
H
I

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3. Symbols & nameplates
Figure similar.
The nameplate must not be removed!
For ordering spare parts and processing
complaints, the device name, serial number and
year of manufacture will be required.
Symbol
Meaning
Symbol
Meaning
Read the
manual!
Year of
manufac-
ture Device
Serial num-
ber
Important
information!
Article num-
ber
Maximum
user weight
in kg
Care in-
structions
Mainte-
nance in-
structions
Applicable
for indoor
use only.
Manufac-
turer
Visual sig-
nal
Language
Read the
User Man-
ual!
Do not dis-
pose of as
household
waste.
Product complies with (EU) 2017/745
MDR
Caution!
Observe the safety instructions
Unique Device Identifier
(Data: GTIN / LOT (SN) / year of man-
ufacture)
Medical device label
This product is a medical device.
4. Safety instructions
Please observe the following safety in-
structions:
•Before using the device for the first time, the User
Manual must be read completely in order to avoid
damage caused by fault operation or hazards.
•Before each use, check the device for visible dam-
age or deficiencies.
•In case of malfunctions or damage of any kind, the
device must not be used.
Caution: Danger of falling!
•Be sure to check the following aspects before use:
Stability of the product (after complete assem-
bly).
Seat plate for damage.
Adjustment clips of the height adjustment for
tight fit.
Tight fit of the union nuts.
•Do not carry the product with the patient seated.
•Only use the product indoors and on a flat surface.
•Only use the product if completely assembled.
•Do not slump carelessly on the product.
•The user must sit completely on the seat.
•Avoid excessively leaning over the product.
•Avoid wobbling or tilting with the product.
•During use, all legs of the product must be in con-
tact with the floor.
•Adjust all four sets of pipes to the same height.
•Only use the height adjustment in the holes pro-
vided for it.
•Attention! Never use the product without the ad-
justment clips in place.
Caution: Danger of breakage!
•The product is only suitable as a seat for persons.
Observe the permitted user weight (2.1).
•Do not expose the product to great temperature
fluctuations (2.2 & 2.3).
Caution: Danger of pinching or catching!
•Never use the product without the plug.
Caution: Risk of injury!
•There is a risk of injury with surface temperatures
> 40°C. Therefore, do not expose the product to
EN

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high temperatures (e.g. sunlight, radiators, hot wa-
ter). Allow the product to cool before use.
If the product is used by patients with in-
sensitive skin (no temperature perception
or skin damage), a heat check (e.g. touching with
the back of the hand) must be carried out by the
nursing staff.
5. Incident reporting
•Serious incidents in connection with the product
must be reported immediately to the manufacturer
and BfArM.
BfArM: www.bfarm.de/DE
▪Use the reporting functions and provided
forms.
Manufacturer: [e-mail]
6. Warranty
•For this product the manufacturer grants a war-
ranty of 12 months. Compliance with the general
terms and conditions(www.rebotec.de/agbs), as
well as the intended use, are a basic prerequisite.
The statutory warranty provisions shall apply.
•Unauthorised modifications to this product will void
the product’s conformity and the warranty.
6.1.Complaint
•Please contact us before returning the product.
•To reduce transport damage, use the original
packaging if possible.
•The Infection Protection Act must be complied
with.
Please make sure that the product does not
pose a risk of infection when returned.
Enclose the information sheet on safety with the
product.
Costs may incur for returns that are not marked
non-objectionable.
7. Reuse, lifetime
•The product is suitable for reuse. How often the
product can be reused depends on the frequency
and nature of use.
•Before reuse, the product must be reprocessed hy-
gienically and the technical and functional safety
and reliability of the product must be checked and
restored if necessary. See 12.
For more detailed information, please see the
reprocessing instructions (02.12.159) and the
maintenance instructions (02.11.163).
The documents can be downloaded from the fol-
lowing link.
▪www.rebotec.de/downloads
•If the product is used as intended, its lifetime is 3
years. The effective lifetime may vary depending
on the frequency and intensity of use and the gen-
eral condition.
8. Scope of delivery
•1x 368.00.30 shower stool Verona
1x seat plate
4x tube set
•1x user manual (02.08.076)
•1x maintenance instructions (02.11.163)
•1x reprocessing instructions (02.12.159)
•The reprocessing and maintenance instructions
can be ordered or viewed and downloaded at
www.rebotec.de/downloads.
9. Setting up for use
•The product has been carefully inspected in the
factory for freedom from defects and complete-
ness. Please check the product for any possible
damage which may have occurred during transport
and for completeness of the scope of delivery upon
receipt.
9.1.Assembling the tube sets
•Place the seat plate on a clean and flat surface
with the underside facing upwards.
If necessary, use a soft pad to avoid scratches.

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•Remove all union nuts from the sockets (1) by turn-
ing in anticlockwise direction.
•Slide the union nuts onto the tube sets (2) from the
top.
•Hold the union nut together with the tube set and
then push the tube set into the socket (3) to the
end stop.
•Turn the tube set to the desired position.
•Tighten the union nuts hand tight in clockwise di-
rection (2).
•After all tube sets are assembled, turn the article
over.
Make sure that none of the tube sets fall out.
If correctly assembled, this product must not
wobble or tilt on a flat surface.
•The product is now ready for use.
9.2.Adjusting the seat height
•Remove the adjustment clips by lightly pressing
against the flanks.
•Pull out the inner tube to the desired position.
The hole spacing between the individual posi-
tions is 25mm.
Attention! Never use the product without the ad-
justment clips in place.
All tube sets must be set to the same height.
•Now mount the adjustment clips.
Make sure that the inner tube is not pulled out
too far. The adjustment clip must always engage
in one of the holes of the inner tube.
10. Product data
•We reserve the right to make technical develop-
ments and improvements with respect to the de-
sign shown in this User Manual.
•See 14.
Characteristic
Value
1.
User weight
max. 175 kg
2.
Product weight*
2.6 kg
3.
Total weight*
3.1 kg
Skin compatibility
DIN EN 10993-1/-5
*Without accessories.
11. Operation of the product
Attention: Danger of falling!
•Observe the safety instruction (0).
•Before use, it must be ensured that the product is
in proper condition.
•A stable position with no risk of slipping or tipping
over must be ensured.
11.1. Sitting down
•The user must position themselves as close as
possible to the product. If necessary, they can ori-
entate or support themselves with their hands on
the edge of the seat plate.
•If this is not possible due to their physical limita-
tions, the user must seek the assistance of a com-
petent person. This can be done with the help of
an assistive device.
11.2. Getting up
•To get up, the feet must be in contact with the floor.
•Then, slightly shift your weight forward and slowly
rise from the seat.
•Do not lean your body too far forward to avoid the
risk of falling. If necessary, the user must seek help
to get up from the stool.
12. Care and maintenance
12.1. Cleaning and care
The product can be cleaned using a mild
conventional cleaning and disinfecting
agent. After cleaning, wipe the product with a clean,
moist cloth and then wipe it dry with a dry cloth.
•Do not use scouring agents or cleaning agents
with aggressive ingredients (acids, thinners), as
1
2
3

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well as hard cleaning objects (brushes), as other-
wise the surfaces may be damaged or deposits
may form on the materials.
•The product is suitable for machine cleaning and
disinfection. Please observe the reprocessing in-
structions (02.12.159).
12.2. Maintenance
•Wear and tear that is not recognised in time and /
or improper handling, as well as irregular or no
maintenance may result in accidents.
For safety reasons, the product must be
professionally maintained at least once a
year.
•Check product for visible damage
(cracks, breakage, loose parts)
•Check stability before use
•If you have any questions concerning the mainte-
nance of the product, please contact an authorised
dealer or a medical and healthcare supplies store.
•In the event of damage and/or repairs, contact
your authorised dealer immediately.
•Never attempt anyunauthorised modifications or
conversions to the product. These may impair the
safety and proper functioning of the device. In
such cases, REBOTEC will not assume any lia-
bility.
•Only use OEM spare parts for repairs. See 6.
•Please note section 13 and 7.
•After maintenance or repair work has been carried
out, we recommend you clean the product before
using it again.
•Please observe the maintenance instructions
(02.11.163).
13. Spare parts & accessories
No.
Art. no.
Designation
-
02.08.076
User Manual Verona
-
02.12.159
Reprocessing Instructions
-
02.11.163
Maintenance Instructions
1
456.00.25
Foot cap
2
201.90.28
Adjustment clip
3
463.90.40
Union nut
4
442.00.25
End plug
5
468.00.05
Plug
-
284.00.30
Travel bag
Use only REBOTEC spare parts and accessories to ensure the proper and safe functioning of the
device.
1
2
3
4
5

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14. Drawing & dimensions
No.
Designation
Dimensions in
mm
a1
Height min.
410
a2
Height max.
560
b
Depth
390
c
Width
390
d
Seat width
340
Seat depth
340
e
Floor space min.
410 x 410
f
Floor space max.
560 x 560
Dimensions and weights may vary depending on the equipment. There might be minor deviations due
to production tolerances. Subject to change without notice
REBOTEC®
Rehabilitationsmittel GmbH
D-49610 Quakenbrück, Artlandstr. 57- 59
Telephone: [phone]
Fax: [phone]
Web:
www.rebotec.de
Email:
[email protected]
EN