Restrictions For Use; Legal Information - Otto Bock 28R16 Instructions For Use Manual

belt (4) at the detachable end. To adjust the circumference in the chest area, the screws on the
sternal bar can be shifted (Fig. 4) or the side rails can be moved (Fig. 5).
With the orthosis placed on the patient, check the following:
• Pressure, placement and fitting of supports and pelvic band (3)
• Proper tension and fit of the waist belt and orthotic frame
• Fit and hyperextension effect in the sitting position
The orthosis can be easily applied and removed using the locking lever (5). To apply the orthosis,
open the locking lever (5) on the left side of the orthosis (Fig. 6), hook the loose handle onto the
right side of the orthosis (Fig. 7) and fix the orthosis to the body by closing the locking lever (5)
(Fig. 8).
6 Tips for use and care
To ensure the effectiveness of this relatively lightweight device, the orthosis must always be
applied with adequate pressure. Patient acceptance and cooperation play key roles in the ef-
fectiveness along with proper application, periodic examination and orthosis adjustment.
Patients must consistently follow physician guidelines.
The orthosis is fully waterproof to allow the patient to shower or bathe without removing the
orthosis. The orthosis can be cleaned with a damp piece of cloth and neutral soap. The pads (7)
are removable and may be replaced if they are excessively worn.

7 Restrictions for use

The 28R16 Hyperextension Orthosis is designed for use on the patient. This orthosis is designed
for contact with intact skin only. Parts that are shaped for a particular patient and those parts that
come into contact with the skin may present functional or hygienic risks when used by another
person. Functional risks include:
• Formation of cracks in the material (may be invisible to the eye if the paint is undamaged)
• Material fatigue due to alternating shock loading
• Reduced elongation at rupture (strain hardening) after work hardening has occurred several
times
The application period or wearing time of the orthosis depends on medical indication.

8 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary ac-
cordingly.
8.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descriptions
and instructions provided in this document. The manufacturer will not assume liability for damage
caused by disregard of this document, particularly due to improper use or unauthorised modification
of the product.
8.2 CE conformity
This product meets the requirements of the European Directive 93 / 42 / EEC for medical devices. This
product has been classified as a class I device according to the classification criteria outlined in Annex
IX of the directive. The declaration of conformity was therefore created by the manufacturer with sole
responsibility according to Annex VII of the directive.
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