6
5
Note:
The valves are positioned in a housing that seals securely against
the inner surface of the hard socket near the distal end. The valves expel
air under positive pressure when entering a socket. For configurations
L-544611, L-544621, L-544613 and L-544641 the push button needs to be
pressed during removal of the prosthesis to allow air back into the hard
socket.
Warning:
Never use configurations with an expulsion valve (L-544612,
L-544620, L-544640) or other valves without a functional release button
when combined with Iceross Seal-In
®
or other solutions where liner is
sealed against the inside wall of a socket. Some means of allowing air
back in the socket must be in place.
Note:
The device must be fitted and adjusted by a healthcare
professional.
Note:
Intended users of the device are healthcare professionals and
patients.
GENERAL SAFETY INFORMATION
Caution:
The device is for single patient use.
Warning:
In case of functional change or functional loss, the patient
should stop using the device and contact a healthcare professional.
Warning:
If the device shows signs of damage or wear hindering its
normal functions, the patient should stop using the device and contact a
healthcare professional.
Note:
This device has been tested according to ISO 10328 standard to
three million load cycles. Depending on patient activity, this may
correspond to 3–5 years of use.
Warning:
If combined with products with different maximum user weight,
the maximum loading corresponds to that of the weakest product.
Caution:
Össur products and components are designed and tested
according to the applicable official standards or an in-house defined
standard when no official standard applies. Compatibility and
compliance with these standards are achieved only when Össur products
are used with other Össur components.
PRODUCT SELECTION
The device is for moderate impact use, e.g. walking.
The weight limit for the device is 136 kg.
ISO 10328 - P6 - 136 kg *)
*) Body mass limit not to be exceeded!
For specific conditions and limitations of use
see manufacturer’s written instructions on
intended use!
ASSEMBLY
Icelock L-544 Series can either be set up on a thermoplastic socket for
temporary test fit purposes or laminated directly into a socket.
Thermoplastic Socket Procedure
1. Drape a thermoplastic socket with conventional methods. Roughen
distal area.
Note:
Distal area must be clean of dirt, dust, and grease, as otherwise
the bonding connection may not work.
