Rebotec 133 Series User manual

REBOTEC®Rehabilitationsmittel GmbH
DE-49610 Quakenbrück, Artlandstr. 57- 59
Telephone: [phone]
Fax: [phone]
Web: www.rebotec.de
BA-Nr.: 02.03.006/2021-09-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
Walking canes
1. Product description
1.1. Introduction
•The product described here is a medical device of risk class I ac-
cording 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. Care-
fully read this user manual before using the device. Followthe safety
instructions and act accordingly.
2. Features
2.1. Intended purpose
•The product is used for light support and relief in case of restrictions
of the lower extremities.
•It allows the user to pursue their desire for mobility. There must be
sufficient musculature for safe use. Persons with sensory impair-
ments may not be able to use this item. The article does not impose
any special requirements on the education of the user.
Specification:
a=Height adjustable / b=Continuous tube, can be shortened
c=Indoor & outdoor use
1=Standard clip / 2=Squeeze pressure / 3=Squeeze clip
4=Standard pressure
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%. 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 limitations of mechanical strength may
occur.
2.3. Storage & transport
•Temperature range: 5 °Cto 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 car-
ried out in accordance with currently valid regulations. Please con-
tact a disposal company for further information. The Infection Pro-
tection Act must be observed. Please observe any labels and infor-
mation on packaging material and act accordingly.
3. Symbols & nameplates
Symbol
Meaning
Symbol
Meaning
Read the man-
ual!
Year of manufacture
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 conditions(www.rebo-
tec.de/agbs), as well as the intended use, are a basic prerequi-
site. 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 de-
vice 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 possible
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. Therefore,
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 any objects (bag, pouch, etc.) to the walking aid.
•After a long period of disuse: Have the walking aid checked by qual-
ified personnel or a specialist dealer. Do not perform any unauthor-
ised mechanical modifications (product liability!). Do not expose the
Designation
133…
Simplex
3
125 kg
c
a
136…
Handy, left
3
125 kg
c
a
138…
Handy, right
3
125 kg
c
a
142…
Anatom, left
3
125 kg
c
a
144…
Anatom, right
3
125 kg
c
a
146…
Cane with Fischer handle, left
3
125 kg
c
a
147…
Cane with Fischer handle, left
-
125 kg
c
b
148…
Cane with Fisher handle, right
3
125 kg
c
a
149…
Cane with Fisher handle, right
-
125 kg
c
b
133.22.15
Simplex 150
3
150 kg
c
a
133.22.16
Simplex 150, extra long
3
150 kg
c
a
133.22.17
Simplex 175
3
175 kg
c
a
142.22.15
Anatom 150, left
3
150 kg
c
a
144.22.15
Anatom 150, right
3
150 kg
c
a
142.22.16
Anatom 150, extra long, left
3
150 kg
c
a
144.22.16
Anatom 150, extra long, right
3
150 kg
c
a
142.22.17
Anatom 175, left
3
175 kg
c
a
144.22.17
Anatom 175, right
3
175 kg
c
a
121.20.10
Hemi, small, left
3
100 kg
c
a
121.20.20
Hemi, small, right
3
100 kg
c
a
121.10.10
Hemi, large, left
3
100 kg
c
a
121.10.20
Hemi, large, right
3
100 kg
c
a
EN

REBOTEC / BA-Nr.: 02.03.006/2021-09-A01
EN
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 proper-
ties and durability.
•Attention, danger of slipping: Never walk with the walking aid on
snow or ice-covered ground without the anti-skid device (ice claw).
Be careful when walking over damp tiles, floors or crossing loose
carpeting. Never clean handles or suction caps with substances
containing oil. Be careful with unevenness, holes in the ground and
loose subsoil, because the walking aid can slip away unexpectedly
or sink in.
•There is a risk of injury with surface temperatures > 40 °C. Do not
expose theproductto hightemperatures (e.g.sunlight, radiators, 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 ([e-mail]) 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 re-
used depends on the frequency and nature of use. Before reuse, the
product must be reprocessed and the technical and functional safety
and reliability of the product must be checked and restored if neces-
sary. For more information, please see the reprocessing instructions
(02.12.154). The reprocessing instructions and the present oper-
ating instructions are available for download from www.rebo-
tec.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 freedom
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 telescopic aluminium tube with
a clip (2). Before adjustment, the screw connection must be loos-
ened by turningit tothe left. Afteradjustment,the
screw connection must be tightened again.
•Products with a continuous tube must be cut to fit.
9. Product data
•We reserve the right to make technical developments and improve-
ments with respect to the design shown in this User Manual.
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 aggressive solvent
additives (observe the product information!), as well as hard clean-
ing 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 0). Pull the suc-
tion 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:
b / mm
a / mm
133…
730- 955
17
136…
710- 935
17
138…
710- 935
17
142…
720- 945
17
144…
720- 945
17
146…
700- 925
17
147…
up to 1055
22
148…
700- 925
17
149…
up to 1055
22
133.22.15
745- 970
19
133.22.16
845- 1070
19
133.22.17
745- 970
19
142.22.15
740- 965
19
144.22.15
740- 965
19
142.22.16
840- 1065
19
144.22.16
840- 1065
19
142.22.17
740- 965
19
144.22.17
740- 965
19
121.20.10
1210- 1610
19
121.20.20
1210- 1610
19
121.10.10
1460- 1880
19
121.10.20
1460- 1880
19
Art. no.
Designation
200…10
Suction foot 17 mm
200…00
Suction foot 19 mm
200…20
Suction foot 22 mm
201…00
Adjustment clip 22 mm
201…20
Adjustment clip 20 mm
02.03.006
User Manual
02.12.154
Reprocessing Instructions
2