Basko Healthcare MultiMotion Manuel Technique page 47

Please note: There must be no tension on the spring during the fitting
phase. It should only be adjusted during rehabilitation, taking into ac-
count that the patient may have to get used to wearing the orthotics
first. The duration of habituation is determined by the sensibility and
is therefore patient-dependent and can vary from hours to days and is
determined by the treating specialist/therapist.
Patient documentation form
A patient documentation form is included in the package on which the
progression of the active and passive range of motion, spring tension
and wearing time can be recorded. Be sure to give this form to the pa-
tient/carer or therapist concerned.
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 mainte-
nance as described in these user instructions. Non-compliance with the
above may cause the MultiMotion joints to not function or function in-
adequately and may impact the guarantee. Changes, adjustments and
modifications to the product not described in these instructions, are
the responsibility and liability of the person who performs them.
CE conformity
These products meet the requirements in Directive (EU) 2017/745 for
medical devices. These products have been included in Class I based
on classification criteria for medical devices as per annex VIII of the Di-
rective. Basko Healthcare therefore wrote up this conformity statement
entirely at its own responsibility as per annex XI of the Directive.
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