Rebotec Verona Manual de usuario

REBOTEC®Rehabilitationsmittel GmbH

DE-49610 Quakenbrück, Artlandstr. 57- 59

Telephone: +49 (0) 5431/9416-0

Fax: +49 (0) 5431/9416- 66

Web: www.rebotec.de

BA-Nr.: 02.08.076/2021-01-A01 Email: info@rebotec.de

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.

User Manual

Shower stool

Figure similar

Verona

368.00.30

175 kg

 REBOTEC / BA-Nr.: 02.08.076/2021-01-A01
 
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EN 
Table of contents 
Product description .......................3 
1. Introduction ............................................3 
Features ..........................................3 
1. Intended purpose ...................................3 
2. Conditions of use...................................3 
3. Storage & transport................................3 
4. Equipment & functions..........................3 
5. Packaging ...............................................3 
6. Disposal ..................................................3 
Symbols & nameplates..................4 
Safety instructions.........................4 
Incident reporting...........................5 
Warranty..........................................5 
1. Complaint................................................5 
Reuse, lifetime................................5 
Scope of delivery............................5 
Setting up for use...........................5 
1. Assembling the tube sets......................5 
2. Adjusting the seat height ......................6 
Product data ...................................6 
Operation of the product ...............6 
1. Sitting down............................................6 
2. Getting up ...............................................6 
Care and maintenance...................6 
1. Cleaning and care ..................................6 
2. Maintenance............................................7 
Spare parts & accessories.............7 
Drawing & dimensions...................8 
 

REBOTEC / BA-Nr.: 02.08.076/2021-01-A01

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1. Product description

Figure shows:

Seat plate

Plug

Tube set

Tube holder with union nut

Adjustment clip

Foot cap

Guide bush

End plug

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.

REBOTEC / BA-Nr.: 02.08.076/2021-01-A01

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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

REBOTEC / BA-Nr.: 02.08.076/2021-01-A01

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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: pms@rebotec.de

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.

REBOTEC / BA-Nr.: 02.08.076/2021-01-A01

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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

User weight

max. 175 kg

Product weight*

2.6 kg

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

REBOTEC / BA-Nr.: 02.08.076/2021-01-A01

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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

456.00.25

Foot cap

201.90.28

Adjustment clip

463.90.40

Union nut

442.00.25

End plug

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.

REBOTEC / BA-Nr.: 02.08.076/2021-01-A01

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14. Drawing & dimensions

No.

Designation

Dimensions in

Height min.

410

Height max.

560

Depth

390

Width

390

Seat width

340

Seat depth

340

Floor space min.

410 x 410

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: +49 (0) 5431/9416-0

Fax: +49 (0) 5431/9416- 66

Web:

www.rebotec.de

Email:

[email protected]

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