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1.2 Symbols and markings:
Meaning of symbols that can be found on Rehadapt
products, accessories, in instructions for use or on the packaging:
CE is an abbreviation for European Community and this marking provides
customs authorities in the European Union with the information that the
product complies with one or more EC Directive(s).
Comply with the instructions for use.
Article number
Batch designation
Protect against moisture.
Date of manufacture
Manufacturer
Serial number
Medical device
Unique Device Identifier
Chocking hazard. Small parts
1.3 Intended purpose
Intended use: Rehadapt floorstands are self standing stands consisting of a chassis,
a column and an articulated arm. They are intended to hold adaptive technology
devices in position to be used for a beneficiary who sits, stands or lies in front of or
under the stand. While connecting to the payload device with an interface that allows
for quick detachment of the piece of adaptive technology, the adjustable articulated
arm and the column allow for flexible and precise positioning of the device, to ensure
the user‘s operation of the device in spite of possible motor impairments or specific
device requirements. The quick connection interface mates with a semi-permanently
fixated device attachment plate or spigot by Rehadapt or the device manufacturer.
Rehadapt floorstands are not life-sustaining nor life-supporting but they are intended
to be used solely indoors. All necessary technical specifications (including
dimensions and load capacity) are included in the respective assembly instructions
and product description.
Indication: Persons who rely on adaptive technology to communicate (AAC), access
ICT, or operate environmental control units.
Contraindications: None
Patient target group: Patients with hereditary, congenital, degenerative, or acquired
movement disorders, specifically in conjunction with limitations in communication.
Conditions include, but are not limited to:
- Cerebral Palsy
- Neuromuscular diseases such as ALS, SMA, or MS
- Acquired Brain Injuries such as Stroke, TBI or aneurysms
- Rett or Angelman syndrome, or other severe multiple disabilities
Intended users: Rehadapt products are intended to be installed by a qualified
distributor and to be operated by the care personal of the patient (family, caregiver,
teacher, therapist, nursing staff, etc.). In some cases, it might be operated by the
patients themselves if they possess sufficient motor control to do so.
1.4 Scope of delivery:
Please compare the scope of delivery with the instructions for
use of the respective product. Other supplementary products might be necessary, in
order to benefit from full use of the product. These should be included in the delivery
from your supplier. Should you have any questions in this regard, please contact your
supplier.
2. Safety
Rehadapt products have been tested and comply with all specifications and standards
for medical products. However, to ensure safe operation of the Rehadapt products,
you should comply with the following safety instructions and warnings:
2.1 General Safety Instructions and Warnings
Use of unauthorised accessories or unauthorised changes to the product.
Unauthorised accessories or any unauthorised changes made to the product can
result in danger and/or injury to persons and to material damage.
Only ever use accessories approved by Rehadapt for combination with the product
or that have standardised interfaces.
Only make changes to the product if these have been approved by Rehadapt.
Make sure the individual components are assembled correctly. Incorrect assembly
can impair the stability and operation of the product and can cause damage to the
communication aid and as a consequence result in physical injury.
Small parts included in the scope of the delivery and packaging must be stored out
of the reach of children. Risk of suffocation.
Comply with the max. permissible load capacity of the product and the mobility aid,
in order to prevent damage to the Rehadapt product or the mobility aid.
Never use force or excessive strength. This could damage the Rehadapt product
or your communication aid.
Risk of pinching. When using Rehadapt products make sure you keep body parts
well away from moving parts.
We recommend that you do not allow the communication aid to protrude over the
stand space (movable base) of the floorstand. If the communication aid protrudes
over the stand space of the floorstand, it must be borne in mind that there is a
higher risk of tipping and collision, e.g. when passing through door frames.
Do not roll the floorstand over uneven surfaces if a communication aid is attached
to it. When rolling the floorstand always hold the column with both hands in order
to stabilise it.
Only ever use the floorstand on even surfaces.
The floorstand is only suitable for use indoors.
The ends of the legs of the moveable base protrude quite far and could have sharp
edges. Leave sufficient space when walking around the floorstand to prevent
tripping and injury.
If the locking mechanism on the column is released or the communication aid
removed from the projecting arm, parts of the product could suddenly move
upwards due to the gas pressure. Keep body parts well away from the top of the
product when adjusting the column or the communication aid.
Only ever use the floorstand with the brakes on the casters locked. Always make
sure to lock the brakes on the casters after moving the floorstand.
Always pay attention to the moveable base when moving the floorstand, in order
to prevent collisions with objects or persons.
Rehadapt products are delivered ready for use. The use of additional grease or
solvents is not necessary and may only be carried out by trained medical product
advisers. See chapter “Maintenance and Service”
Remove all attached communication aids before transporting the mobility aid or
removing the screws and levers, in order to prevent these from dropping and being
damaged.
Do not attach any decorations or the like permanently to the Rehadapt product that
are not included in the scope of delivery and scope of use, as these could impair
the operation and the stability of the product. Make sure that any safety instructions
or warnings on the product are clearly visible.
2.2 Assembly
The user and the specialist staff of the supplier are responsible for safety and
operation. Make sure the product is assembled correctly and firmly, to ensure
reliable operation. Rehadapt excludes any liability for improper assembly.
2.3 Service life
Using the device after expiry of its specified service life leads to an increase in the
residual risks and should only be undertaken after careful consideration by
qualified specialist staff of the supplier. Once the service life has expired, the user
or a responsible person should contact the supplier. The supplier can then decide
whether the product can be reconditioned or its use extended.
2.4 Safety of children
Always bear in mind that Rehadapt products are not toys and should therefore
never be used by children or persons with limited judgement capacity as play
things, as this could result in the risk of personal injury or the risk of damaging the
communication aid or the Rehadapt product. Rehadapt products consist of several
individual parts that are assembled to produce a complete device. If the individual
parts of the product are removed, the danger of swallowing these removed parts
could arise or other risks of accident arising from the now open mounting points.
Small children or persons with limited judgement capacity should not be permitted
to modify the Rehadapt products unless under the supervision of caregivers.
2.5 Reporting of serious cases:
Please report all incidents to the following email
([email protected]). “Incident” means a malfunction or deterioration of the
properties or performance of the Rehadapt product, including use errors due to
ergonomic features, as well as any inadequacy in the information provided by
Rehadapt or the supplier or any undesirable side-effects. All serious incidents that
occur in connection with the product must be reported to Rehadapt.
3. Assembly
Rehadapt product must be assembled as indicated in the instructions for use. All
general safety instructions and warnings must be complied with. Communication aids
may only be attached to the Rehadapt product in compliance with the specifications of
the device manufacturer or in compliance with the specification of Rehadapt. Other
supplementary products might be necessary for this, in order to benefit from full use of
the product. Improper assembly of Rehadapt products might impair the safety and
operation of mobility, seat or stretcher aids (e.g. centre of gravity of the mobility aid
shifted by the mounting of additional communication aids on the Rehadapt products).
Please contact the supplier of the mobility, seat or stretcher aid if you are in any doubt
about the maintenance of the safety and performance ability of the other aid.
4. Maintenance and Service
4.1 Maintenance and Care:
A damaged product or damaged components could injure
the user or a third party. Only use a product and components if you are sure they are
not faulty. If you are in any doubt, please contact your supplier. Repairs, maintenance
and safety inspections may only be carried our by trained and qualified personnel. We
recommend you have your Rehadapt product serviced at least once a year by qualified
personnel. Contact your supplier to arrange this.
4.2 Check of intended use:
In order to ensure intended use all connections on the
Rehadapt products must be made in compliance with the instructions for use. Whereby
screw connections must not be tightened to the maximum permissible torque. Check
regularly that safe use is ensured. You can obtain detailed information and help with
all questions concerning maintenance and service from your supplier or directly from
Rehadapt.
4.3 General Cleaning Instructions:
All Rehadapt products should be cleaned at
regular intervals, in order to ensure flawless hygiene and operation. Cleaning
requirements depend on the type of use and usage environment of the product. The
user or his/her caregivers bear sole responsibility for the cleaning of a product. Failure
to carry out the necessary cleaning could result in loss of the product warranty as well
as impairment of the clinical condition and safety of users and/or caregivers.
Attention!
All guidelines listed here are indicative only. More detailed “Cleaning and
Disinfection Guidelines” can be found on our website (www.rehadapt.com) for each
product. We recommend you wear gloves during cleaning. Make sure no water can
penetrate the tubes, bearings or joints.
