Basko Healthcare BINKY Manuel Technique page 5

BINKY
Please read these instructions carefully before using the product.
Pay particular attention that the safety instructions are followed.
Usage guidelines
The product may only be fitted by or under the supervision of a competent professional
Special precautions must always be taken for patients with a visual impairment, cognitive
limitations and/or reduced sensibility in the upper and/or lower extremity
Changes, modifications and adjustments to the product that are not described in these
instructions, are done at the sole responsibility of the person carrying them out
Intended use / Application
These universal joints without flexion and / or extension stops are used pairwise for the production
of orthoses made out of thermoplastics or separately as a free motion joint. BINKY joints are
suitable for use by both children and adults in orthoses for wrist, elbow, and ankle joint. The
physician is the one who determines the indications and also determine the duration of treatment.
Indications
Paralytic syndromes (other) (ICD 10: G83.-).
Contraindications:
There are no known contraindications.
General safety instructions
Risk of injury due to excessive load on the joints: structural limits and specific values i.e. body
weight may determine size selection of the joints. Excessive flexion loads may lead to breakage of
the joints.
Risk of injury due to joint alignment deviations: during fabrication, correct joint alignment must be
assured in the frontal and sagittal plane to ensure smooth movement of the joints.
Risk of injury by using the wrong materials: the joints have been developed for usage in orthoses
made of thermoplastic material. The use of the joint in orthotics made of other materials is not
recommended.
Risk of injury as a result of incorrect use: the professional should verify correct functioning of the
joints prior to delivery of the orthosis to the user. The patient and his/her care giver(s) should
also be instructed on donning and doffing. Any settings may only be changed by the technician,
therapist or doctor.
Used materials
Stainless steel
Joint selection
BINKY joints are available in 2 sizes. Directive is to apply the 814101 when used on small joints and
the 814102 for larger joints. Other than that, it is up to the professional judgment of the technician
to select the desirable joint based on knowledge and experience.
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Size chart
Art. Nr. Unit Length
814101 1 pair 62 mm
814102 1 pair 76 mm
Maintenance recommendation
We recommend a service check on functionality, wear and tear once every six months.
Cleaning instructions
The joint may be cleaned with naphtha or similar. Try to keep the joint free from dust and dirt as
much as possible.
Package content
1 set BINKY joints
1 alignment tool
Technical instructions
Check the package label to make sure the article number corresponds with the content of the
package.
Handling
All general applicable technical and anatomical directives should be taken into account when
manufacturing the plaster model, determination of pivot points, alignment, assembly and
orthosis construction
Each joint needs to be mounted onto the orthosis at all 4 markings on the joint itself
It's up to the professional's own preferences and understanding which assembly technique
(drilling, tapping, riveting or otherwise) to use for mounting the joints to the orthosis
Liability
Basko Healthcare as the manufacturer is solely liable if the product is used in accordance with the
prescribed conditions and the purpose for which it is intended. Basko Healthcare recommends
handling the product in accordance with applicable rules and performing maintenance as
described in these user instructions. Non-compliance with the above may cause the BINKY joints to
not function or function inadequately and may impact guarantee.
CE-conformity
These products meet requirements in Directive 93/42/EEC for medical devices. These products
have been included in Class I based on classification criteria for medical devices as per annex IX
of the Directive. Basko Healthcare therefore wrote up this conformity statement entirely at its own
responsibility as per annex VII of the Directive.
Width Thickness Body weight
12 mm 2,5 mm < 35 kg
18 mm 2,5 mm < 100 kg
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