The product is intended exclusively for use on one patient. Use of the product by another person
is not approved by the manufacturer.
The product is to be used solely for upper limb prosthetic fittings.
•
For patients with unilateral and bilateral amputations.
•
For patients with transcarpal and transradial amputation.
3.3 Contraindications
•
For patients with transhumeral amputation.
•
For patients with partial hand amputation.
•
For patients with shoulder disarticulation.
•
For patients who are not able to generate an adequately separable pattern.
3.4 Qualification
Fitting a patient with the product may only be carried out by O&P professionals who have been
authorised by Ottobock after completion of a corresponding training course. The O&P profes
sional also has to have the technical qualifications required for the alignment of a prosthesis with
all required settings and adjustments.
The "O&P professional mode" of the adjustment app may only be used by qualified personnel,
therapists and nursing staff after participating in the relevant product training and obtaining certi
fication for the application. Additional product training courses may become necessary to qualify
for app updates.
4 Safety
4.1 Explanation of warning symbols
Warning regarding possible serious risks of accident or injury.
WARNING
Warning regarding possible risks of accident or injury.
CAUTION
NOTICE
Warning regarding possible technical damage.
4.2 Structure of the safety instructions
CAUTION
The heading describes the source and/or the type of hazard
The introduction describes the consequences in case of failure to observe the safety instruc
tions. Consequences are presented as follows if more than one consequence is possible:
>
E.g.: Consequence 1 in case of failure to observe the hazard
>
E.g.: Consequence 2 in case of failure to observe the hazard
►
This symbol identifies activities/actions that must be observed/carried out in order to avert
the hazard.
4.3 General safety instructions
WARNING
Operating the product near medical devices critical for safety
Interference with life-sustaining medical devices (e.g., pacemaker, defibrillator, heart-lung
machine, etc.) due to electromagnetic interference of the product.
►
When operating the product in the immediate vicinity of life-sustaining medical devices,
ensure that the minimum distances stipulated by the manufacturer are observed.
►
Make sure to observe the operating conditions stipulated by the manufacturer and the safety
notices.
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