Rebotec 363.00.20 User manual

REBOTEC®Rehabilitationsmittel GmbH
DE-49610 Quakenbrück, Artlandstr. 57- 59
Telephone: [phone]
Fax: [phone]
Web: www.rebotec.de
BA-Nr.: 02.08.204/2021-01-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
Cannes
363.00.20
130 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 ...............................................4
2.6. Disposal ..................................................4
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. Assembling the armrests ......................6
9.3. Adjusting the seat height ......................6
10. Product data ...................................7
11. Operation of the product ...............7
11.1. Sitting down............................................7
11.2. Getting up ...............................................7
12. Care and maintenance...................7
12.1. Cleaning and care ..................................7
12.2. Maintenance............................................7
13. Spare parts & accessories.............8
14. Drawing & dimensions...................9

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1. Product description
Figure shows:
A
Seat plate
B
Armrests
C
Clips
D
Tube set
E
Tube holder with union nut
F
Adjustment clip
G
Foot cap
H
Guide bush
I
End plug
J
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: 130kg
•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
•Seat plate with hygiene cutout
•Armrests
•Removable
A
B
C
D
F
E
G
H
I
B
J

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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.
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.
Symbol
Meaning
Symbol
Meaning
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.
Check armrests for damage.
Check the backrest for damage.
Clips of the height adjustment for tight fit.
Clips the backrest and armrests 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.
EN

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•Attention! Never use the product without the 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!
•Do not reach between the clamping elements (9.2)
during assembly.
Caution: Risk of injury!
•There is a risk of injury with surface temperatures
> 40°C. Therefore, do not expose the product to
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 363.00.20 shower seat Cannes
1x seat plate
4x tube set
2x armrest
4x clips in bag
•1x user manual (02.08.204)
•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
•No tools are required for assembly.