Rebotec Big 250 User manual

REBOTEC®Rehabilitationsmittel GmbH
DE-49610 Quakenbrück, Artlandstr. 57-59
Telephone: [phone]
Fax: [phone]
Web: www.rebotec.de
BA-Nr.: 02.01.120/2022-06-A01 Email: [email protected]
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
Big 250 & Big 250 Extra long
1. Product description
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 prod-
uct. Carefully read this user manualbefore using the device. Fol-
low the safety instructions and act accordingly.
2. Features
2.1. Intended purpose
•The product is used for support and relief in case of restrictions
of the lower extremities. It allows the user to pursue their desire
for mobility. There mustbe sufficient upper body musculature for
safe use. Persons with sensory impairments may not be able to
use this item. The article does not impose any special require-
ments on the education of the user.
Specification:
a=Height-adjustable / c=Indoor & outdoor use
1=standard clip
2= clamping clip
2.2. Conditions of use
•Temperature range: -10°C to +35°C; direct radiant heat on the
product must be avoided. Relative humidity: 40% to 85%. Out-
side 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 limitations of mechanical strength
may occur.
2.3. Storage & transport
•Temperature range: 5 °C to 25 °C; direct radiant heat on the
product must be avoided. Store the product in dry rooms with a
humidity of up to 65%.
2.4. Disposal
•Disposal and recycling of used products and packaging must be
carried out in accordance with currently 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
Symbol
Meaning
Symbol
Meaning
Read the manual!
Year of manufac-
ture of Device
Article number
Manufacturer
Language
Maximum user
weight in kg
Important infor-
mation!
Product complies
with (EU)
2017/745 MDR
4. Warranty
•For this product the manufacturer grants a warranty of 12
months. Compliance with the general terms and condi-
tions(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.
4.1. 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 infec-
tion when returned. Enclose an information sheet on safety with
the product. Costs may incur for returns that are not marked
non-objectionable.
5. Safety instructions
Please observe the following safety instructions:
•Before using the device for the first time, the
User Manual must be read completely in order to avoid
hazards or damage caused by maloperation. Before each use,
check the device for visible damage or deficiencies. In case of
malfunctions or damage of any kind, the device must not be
used. Regularly check the suction foot for damage and wear;
replace if necessary.
•The walking aid must be placed on the floor as vertically as pos-
sible when walking. Therefore, never position the walking aid too
far away from the body or forward in the walking direction. Grasp
the handle completely and firmly with one hand. If possible,have
an assistant accompany and support you so that they can catch
you if you fall.
•The walking aid must not be used for any other purpose. There-
fore, only use them to support your ability to walk and not, for
example, as a stand-up aid, for levering, moving furniture or
other objects. Do not attach anyobjects (bag, pouch, etc.) to the
walking aid.
•After a long period of disuse: Have the walking aid checked by
qualified personnel or a specialist dealer. Do not perform any
unauthorised mechanical modifications (product liability!). Do
not expose the walking aid to sunlight for a longer period of time
(at the window, at the heater, in the car). Heat can lead to
changes in material properties and durability.
•Attention, danger of slipping: Be careful when walking over
damp tiles, floors or crossing loose carpeting. Never clean han-
dles or suction caps with substances containing oil. Be careful
with unevenness, holes in the ground and loose subsoil, be-
cause the walking aid can slip away unexpectedly or sink in.
Designation
106.00…
Big 250
1
2
250 kg
c
a
106.04…
Big 250, extra long
1
2
250 kg
c
a
EN

REBOTEC / BA-Nr.: 02.01.120/2022-06-A01
EN
•There is a risk of injury with surface temperatures > 40°C. Do
not expose the product to high temperatures (e.g. sunlight, radi-
ators, hot water). Allow the product to cool before use.
If the product is used by patients with insensitive 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.
6. Incident reporting
•Serious incidents in connection with the product must be re-
ported immediately to the manufacturer ([email protected]) and
BfArM (www.bfarm.de/DE). Use the BfArM reporting functions
and provided forms.
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 re-
use, the product must be reprocessed and the technical and
functional safety and reliability of the product must be checked
and restored if necessary. For more information, please see the
reprocessing instructions (02.12.154). The reprocessing instruc-
tions and the present operating instructions are available for
download from www.rebotec.de/downloads.
•When used as intended, the product has a lifetime of 2 years.
The effective lifetime may vary depending on the frequency and
intensity of use and the general condition.
8. Setting up for use
•The product has been carefully inspected in the factory for free-
dom from defects and completeness. Please check the product
for any possible transport damage and the completeness of the
scope of delivery upon receipt.
8.1. Adjustment to body height
•Have the product adjusted to your body height by the competent
qualified personnel. The height is adjusted by means of a tele-
scopic aluminium tube with a clip (1). If the
product has a screw connection, this must be
loosened by turning to the left before adjust-
ment. After adjustment, the screw connection
must be tightened again.
8.2. Height adjustment of the armrests (triple)
•To adjust / mount the armrest, press the push
button and slide the armrest into the desired po-
sition until the push button clicks into place.
•Completely press the spring bolt (1) into the
hole.
•Move the armrest (2) to the desired position
•Have the spring bolt snap into the hole.
8.3. Handle height adjustment (10-fold)
•Press the clamping lever down to the stop (1).
•Completely press out the clip from the hole (2).
•Slide the tube to the desired hole position (3).
•Press the clip and fold the clamping lever completely (4).
9. Product data
•We reserve the right to make technical developments and im-
provements with respect to the design shown in this User Man-
ual.
10. Cleaning and care
•The device can be cleaned using a mild conventional cleaning
and disinfecting agent. After cleaning, wipe the device with clean
water and a cloth and then wipe the walking aid dry with a clean
cloth. Do not use scouring agents or cleaning agents with ag-
gressive solvent additives (observe the product information!), as
well as hard cleaning objects, as otherwise the surfaces may be
damaged or deposits may form.
11. Maintenance
•Have your walking aid checked by your specialist dealer at least
1x every six months. Worn suction feet (wearing part) must be
replaced immediately. Pay attention to the diameter (see 9). Pull
the suction foot off the end of the tube. Push on the new suction
foot as far as it will go and check that it is firmly seated.
Spare parts & accessories:
A / mm
B / mm
C / mm
α
106.00…
225-250
745-970
22
20°
106.04…
225-250
845-1070
22
20°
Art. no.
Designation
201.00.25
Adjustment clip 25mm, grey
201.10.25
Adjustment clip 25mm, black
02.01.120
User Manual
0.12.154
Reprocessing Instructions
160.02.03
Arm rest padding, Big
160.01.03
Handle padding, Big
168.10.22
Big Foot, PU anti-slip buffer
167.00.10
REBOflex
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1
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