4
5
4. Side effects
There are no known side effects.
5. General safety instructions
•
This medical product is designed for: single patient, multiple use.
•
Fitting/service of this medical device is only allowed by a certificated orthopedic
professional.
•
Improper modification or application to the product is not allowed. In case of non-
observance, the function of the product may be impaired, so that product liability
is excluded.
•
Only approved screws may be used.
•
The maximum weight loads are listed under “2. Technical Data”. Additional loads
must be taken into account when calculating the weight.
6. Installation
6.1 A1, A2 und A40 Tube clamp Adapters
Before fitting the tube, first loosen the Hexagon socket head cap screw (M33) with two
turns.
Always position the tube clamp adapter proximal to the tube adapter. It is
not permitted to pull out the tube from the tube clamp adapter to adjust the
length.
Tighten Hexagon Socket Head Cap Screw (M33) with a Torque Wrench.
Tightening torque A1 and A2: 10 Nm
Tightening torque A40:
8 Nm
6.1.1 Instructions of Use - Headless Screws (A1 and A2 only)
By using the adjusting screws M28-12 or M28-16, static corrections are possible at any
time. If a module has to be replaced or removed the previously adjusted position is
maintained if only two adjacent adjusting screws (not opposite), the ones screwed in
at the deepest, are removed.
If the adjusting screws are, too long (damage of the foam cover) or too short
(reduced stability) these have to be replaced with appropriate ones.
Use a toque wrench to tighten the adjusting screws.
Tightening torque: 12 Nm.
Secure the various screws, used for assembly, with Loctite 222.
6.2 A30 Reducation Adapter
The A30 Reducation Adapter with the outer tube attachment (ø 34 mm) is inserted into
the distal attachment of a JT09, JT20, JT20S, JT22 or JT22S (Uniprox knee joints) as
far as possible.
The clamp adapter is aligned distally/dorsally and screwed to the respective tube
clamp adapter of the modular knee. Use the torque wrench provided.
The distally aligned 30 mm tube attachment accepts a 30 mm modular tube adapter.
Tightening torque: 8 Nm
The various screws used for assembly purposes must be secured with
Loctite Loctite® 243.