Schuchmann BIBI User manual

Instructions for use.
bibi. The lightweight and compact bath seat.
bibi.

Many thanks.
Dear Customer
At this point we would like to thank you for placing your trust in our company and
for purchasing our product. We ask you to read through the Instructions for use carefully
prior to initial commissioning of the product, and to observe them. Please note that
guidelines and representations in these Instructions for use may deviate from your product
due to diering equipment. We reserve the right to make technical modifications.
Important information!
Ensure that these Instructions for use remain with the product.
Your schuchmann Team

03 Contents.
1. Preparation. .................................................................................. 04
1.1 Delivery............................................................................................................................04
1.2 Safety measures prior to use..............................................................................04
1.3 Safe disposal...............................................................................................................04
1.3.1 Packaging...........................................................................................................04
1.3.2 Product................................................................................................................04
1.4 Where to store the instructions for use..........................................................04
2. Product description. ...................................................................... 05
2.1 Material information ................................................................................................05
2.2 Transport / handling ..............................................................................................05
2.3 Application areas, use according to the intended purpose .............05
2.3.1 Indication ...........................................................................................................05
2.3.2 Contraindications .........................................................................................05
2.4 Use not in accordance with the intended purpose / warning gui-
delines............................................................................................................................06
2.5 Equipment for basic model.................................................................................06
2.6 List of accessories....................................................................................................06
2.7 Product overview......................................................................................................06
3. Settings. ....................................................................................... 07
3.1 Back angle ................................................................................................................... 07
3.2 Cover ..............................................................................................................................07
4. Cleaning and maintaining. ............................................................ 08
4.1 Cleaning and disinfecting....................................................................................08
4.1.1 Cleaning..............................................................................................................08
4.1.2 Disinfection........................................................................................................08
4.2 Servicing.......................................................................................................................08
4.3 Maintenance ..............................................................................................................08
4.4 Spare parts.................................................................................................................09
4.5 Duration of use and re-use ................................................................................09
5. Technical data. .............................................................................. 10
6. Guarantee. .................................................................................... 10
7. Identication. ............................................................................... 11
7.1 EU Declaration of Conformity................................................................................ 11
7.2 Serial number / date of manufacture............................................................. 12
7.3 Product version ........................................................................................................... 12
7.4 Issue of the document ............................................................................................ 12
7.5 Name and address of the manufacturer, specialist dealer supplying
the product................................................................................................................... 12

04 1. Preparation.
1.1 Delivery
On receiving the product, please check it for completeness, lack of faults
and any transport damage. Inspect the goods in the presence of your
forwarder. Should transport damage have occurred, please arrange for
an inventory (determination of the faults) to be made in the presence of
the forwarder. Please send a complaint in writing to the specialist dealer
responsible.
1.2 Safety measures prior to use
The correct use of the product requires a detailed and careful instruction
of the user or the accompanying person. We ask you to read through the
Instructions for use carefully prior to initial commissioning of the product,
and to observe them. It is possible that product parts that get in contact
with the skin may heat up in the sun. Cover these areas or protect the de-
vice from direct sunlight.
1.3 Safe disposal
In order to preserve and protect the environment, to prevent environmental
pollution and to improve the recycling of raw materials, please note the
disposal instructions in points 1.3.1 and 1.3.2.
1.3.1 Packaging
The packaging of the product should be kept for any future transport that
might be required. Should you have to return the product for repairs or in
case of a guarantee claim, please if possible use the original box so that
the product is optimally packaged. Otherwise, separate the packaging
materials for recycling according to their classification.
Do not leave packaging materials unattended, as they are a possible source of
danger.
1.3.2 Product
Attheendoftheproductlifecycle,recycletherawmaterialsusedintheproduct
according to their nature (see material information under point 2.1).
1.4 Where to store the instructions for use
Please store these Instructions for use carefully and ensure that these inst-
ructions for use remain with the product in case of re-use. Should you lose
the instructions, you can always download an updated version at www.
schuchmann.de .

05 2. Product description.
2.1 Material information
Theframeismadefromaluminium,freefromcorrosionandpowder-coated in
black. The internal structure of the ratchet joints is made of stainless steel and
is free from corrosion. The removable and washable net cover is made from
100% polyester.
2.2 Transport / handling
Due to the low weight, bibi. can be handled with ease. You can lift the
bath seat at any point. To transport the bath seat, adjust the settings to
the most compact dimensions.
2.3 Application areas, use according to the intended purpose
The bibi mobile bath seat is a medical product of risk class 1 and is suited
exclusively for use in bathtubs, showers, in the sandbox and on the beach.
It supports the user who cannot sit freely and oers additional support
thanks to retaining straps. Any other use or use over and above this pur-
pose shall be considered not in accordance with the intended purpose.
2.3.1 Indication
The bibi. bath seat is suitable for:
• Users who are unable to sit or lie down in the bathtub due to
dysfunction of the lower limb with significantly reduced or
complete failed joint mobility
• Users with limitation to the muscular strength of the lower
extremities
• Users with damage to the nervous system, damage to
neuromusculoskeletal functions
• Users with damage to the movement-related function and/or muscle
function and/or with damage to the neurological function
• Users with movement patterns with significantly reduced or failed trunk
control or reduced or failed body control
2.3.2 Contraindications
In general, the indication should be accompanied by a doctor/
orthopaedist. It should therefore be clarified prior to procurement whether
contraindications exist for the patient. In general, any type of pain
represents a contraindication.

06 2. Product description.
2.4 Use not in accordance with the intended purpose / warning guidelines
• Make sure that the bath seat is used by only one user.
• Never leave the user unattended in the bath seat.
• The correct use of the bath seat requires precise and careful training of
the attending caregiver.
• The max. load of 30 kg must not be exceeded.
• Do not use the bath seat with defective, worn or missing parts.
• For fire safety reasons, the bath seat must not be placed near an open
fire or other strong heat source such as an electric or gas heater.
• Use only accessories and spare parts made by Schuchmann, otherwise
you will compromise the safety of the user.
• Use the bath seat only if all components have been correctly fitted and
adjusted.
• The bath seat is not suitable to transport persons.
• Users with reading diculties must have the instructions read to them to
understand handling the bath seat.
2.5 Equipment for basic model
• Aluminium frame with removable cover
• Backrest can be adjusted at an angle
• incl. lap belt
2.6 List of accessories
• additional lap belt
2.7 Product overview
The fig. below is intended to show you the designation of the most import-
ant components as well as the terms which you will find in these Instruc-
tions for use.
Backrest
Back angle adjustment
Lap belt
Seat
Frame, black
powder-coated

07 3. Settings.
Settings and adjustments to the product or accessories may only be made
by people who have been given the necessary instructions by a medical
product advisor. Please ensure that none of the user's extremities are in
the respective area when making adjustments of any kind to minimise the
risk of injury.
3.1 Back angle
The backrest can be adjusted at an angle.
To this end, press the two ratchet joints (A)
simultaneously and put the backrest in the
desired position. After the positioning, release
the ratchet joints and ensure that the ratchet
joints have engaged.
bibi.canbefoldedinaspace-savingmannerfor
transport.
The ratchet joints must engage after each
adjustment!
3.2 Cover
The cover can be adjusted via the belt loops
in the back or seat area. To this end, you can
use two belt loops for the back area (B) and
two for the seat area (C).
Make sure that the hook and loop closures are
closed!
A
A
B
C

08 4. Cleaning and maintaining.
4.1 Cleaning and disinfecting
4.1.1 Cleaning
Please clean all frame elements regularly with a spon-
ge or damp cloth; making sure that water droplets are
removed. Please clean with a mild household deter-
gent for severer dirt. Thorough drying of the cleaned
areas is important.
All fabrics that cannot be removed can be wiped with
a moist cloth. For all removable fabrics please pay at-
tention to the sewn-in care labels (such as A+ B) on the
respective element.
Please also pay attention to our general clea-
ning and hygiene advice. This can be found at
www.schuchmann.de/mediathek.
4.1.2 Disinfection
Various products can be used for surface disinfection of metal and plastic
parts.
Liquid disinfectants are available as ready-to-use solutions that are spray-
ed on and evenly applied with a soft cloth. Alternatively, wipes pre-soaked
with disinfectant can be used to wipe the products over the entire surface.
In both cases, care must be taken to ensure complete wetting. Disinfection
in fully automatic disinfection systems is also possible and recommended.
The exposure times may vary and can be found in the manufacturer's ins-
tructions for the products used.
4.2 Servicing
Please carry out a visual inspection on a daily basis and regularly check
the product for cracks, breaks, missing parts and malfunctions. In case of a
defect or malfunction, please contact the specialist dealer who supplied
you with the product (see Point 7.5).
4.3 Maintenance
The product does not require maintenance.
7190045
A
Obermaterial/
top cloth/dessus:
100% Polyester
B

09
4.4 Spare parts
Use only original accessories and original spare parts from Schuchmann,
as otherwise the safety of the user is endangered and the warranty
expires.
To order spare parts, please contact the supplying specialist dealer (see
point 7.5) stating the serial number of the product. Necessary spare parts
and accessories must only be installed by trained personnel.
4.5 Duration of use and re-use
The expected duration of use of our product, dependent on the usage in-
tensity and amount of re-use, totals up to "8" years if the usage takes place
in accordance with the information in these Instructions for use. It may be
possible to use the product over and above this time period if it is in a
safe condition. The expected duration of use does not refer to wear parts,
such as for example wheels, gas pressure springs,... . The maintenance and
evaluation of the condition, and if applicable the potential for re-use, must
be decided by the specialist dealer.
The product is suited for re-use. Prior to forwarding, please follow the clea-
ning and disinfection instructions stated in point 4.1. Accompanying docu-
ments such as these Instructions for use are part of the product and must
be passed on to the new user. No disassembly is required prior to re-use. In
the case of storage, it is recommended to fold the product to the smallest
dimension to save space.
Should a serious incident occur during the service life of the product despite
being used as intended
, this must be reported immediately to the manufactu-
rer and the competent authority.
4. Cleaning and maintaining.

10
Dimensions
5. Technical data.
bibi. bibi. with long backrest
ASeat depth 30cm 30 cm
B Seat width 36cm 36 cm
C High back 45cm 55cm
D Total length 60cm 60 cm
Back angle 90° - 180 ° 90° - 180 °
max. load 30kg 30kg
Weight 2.3kg 2.3kg
6. Guarantee.
The two-year statutory guarantee period shall apply for all products.
It starts with the delivery or handover of the goods. Should a verifiable
material or manufacturing fault occur within this time period, we shall, after
carriage paid return to us, view the indicated damage and, if applicable,
either repair or deliver a new product at our discretion.

11 7. Identication.
7.1 EU Declaration of Conformity
EU Konformitätserklärung
EU Declaration of Conformity
Firma / Company Schuchmann GmbH & Co. KG
Rudolf-Runge-Str. 3 · 49143 Bissendorf · Deutschland / Germany
Tel. [phone] / 40 71 00 · Fax [phone]
erklärt in alleiniger Verantwortung, dass das nachfolgend genannte Produkt der Risikoklasse 1
declares under our sole responsibility that the following product(s) of Class 1 Medical Devices
Datei: Konformitätserklärung bibi Stand: Rev. 2.0 Seite: 1
„bibi.“Badesitz / bathing seat
Art.-Nr. / Item-No.: 55 01 000, 56 01 001, 55 01 002
Basis UDI-DI /
Basic UDI-DI: 4251040200004000550XXXXBG
den einschlägigen Bestimmungen der im folgenden aufgeführten Richtlinien und Standards entspricht:
is / are in conformity with the requirements of the below listed directives and standards:
Verordnung (EU) 2017/745 über Medizinprodukte vom 05. April 2017
Regulation (EU) 2017/745 on medical devices of 5 April 2017
DIN EN 12182:2012 Technische Hilfen für behinderte Menschen
T
echnical aids for disabled persons
DIN EN ISO 14971:2013 Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte
Medical devices - Application of risk management to medical devices
Diese Konformitätserklärung gilt nur für Produkte mit den oben genannten Artikelnummern und
ist gültig bis zum 31.12.2023.
This declaration of conformity applies only for products with above-named Item-numbers
and is valid until 31.12.2023.
Datum / Date: 01.04.2020
Unterschrift /
Sign:
Name /
Name: Torsten Schuchmann
Funktion /
Function: Sicherheitsbeauftragter für Medizinprodukte / Safety officer for medical devices

1212 7. Identication.
7.2 Serial number / date of manufacture
The serial number, the date of manufacture and other information can be
found on the type plate, which is located on all of our products (A).
7.3 Product version
The bath seat bibi. is available in two sizes and can be complemented by
accessories (see point 2.6).
7.4 Issue of the document
Instructions for use bibi. - Change status G; issue 09.2020
7.5 Name and address of the manufacturer, specialist dealer supplying
the product
This product was manufactured by:
A
Product name
Item number
Serial number
schuchmann.de • [e-mail] • Fon +49 (0) 5402 / 40 71 00
Rudolf-Runge-Str. 3 • 49143 Bissendorf • Germany
Barcode UDI-DI Barcode UDI-PI
UDI-DI
SN / UDI-PI
Type
Product
Max. load
Size
MD
Size
max. load
Date of manufacture
Product labelling in accordance with MDR
GA 55 - EN_1.0
This product has been delivered by the following specialist dealer:
Schuchmann GmbH & Co. KG
Rudolf-Runge-Str. 3 · 49143 Bissendorf · Germany
Phone [phone] / 40 71 00 · Fax [phone]
[e-mail] · www.schuchmann.de