Orthofix GALAXY UNYCO SYSTEM, Инструкция

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NOTE: UNYCO Screws and UNYCO Cancellous Screws must always be used in association with the Large Multiscrew Clamp for UNYCO Screws in a pin cluster. If faced with a
segmental fracture, the most proximal and most distal bone segments are held using the Large Multiscrew Clamp for UNYCO Screws and the intermediate segment can be held
using a UNYCO Screw in a Galaxy Large Clamp attached to the same connecting rod that links the two Large Multiscrew Clamps for UNYCO Screws.
CONTRAINDICATIONS
The Orthofix Galaxy UNYCO Diaphyseal Tibia Kit is not designed or sold for any use except as indicated.
Use of the system is contraindicated in the following situations:
• Patients with mental or physiological conditions who are unwilling or incapable of following postoperative care instructions
• Patients with severe osteoporosis
• Patients with malignancy in the fracture area
• Patients with foreign body sensitivity. Where material sensitivity is suspected, tests should be made prior to implant insertion
WARNINGS & PRECAUTIONS
1. Fracture stabilization has to be done following correct fracture reduction.
2. The arms of the Large Multiscrew Clamp for UNYCO Screws can be disassembled to allow the most suitable configuration (M or U) while the other components cannot be
disassembled.
3. Before fixator application, make sure that the Large Multiscrew Clamps for UNYCO Screws are fully loosened.
4. UNYCO Screws must be inserted at right angles to the bone surface using a steady force to ensure optimal bone purchase.
5. Once the first screw has been inserted freehand and its correct position on the bone has been checked, apply the Galaxy UNYCO Tibia Clamp (93566) on the first screw and
tighten the metal ring on the arm clockwise.
6. The system stability is guaranteed only with a minimum of 3 UNYCO screws (2 of them must be UNYCO screws 93507) coupled with the Large Multiscrew Clamp for UNYCO
Screws in each segment. The use of four UNYCO screws is to be preferred. The Large Multiscrew Clamp for UNYCO Screws should never be applied across the fracture line.
7. Frame stability must be checked intra-operatively before the patient leaves the operating theatre. If one UNYCO screw is perceived as unstable, re-insert it in a new bone area,
using the 10° freedom of movement to find the new insertion point.
8. Depending upon the clinical and radiological findings, the surgeon will decide on the number of UNYCO Screws (93507) and UNYCO Cancellous Screws (93508) needed to
achieve the appropriate frame stability. Remember that the first screw determines the position of the remaining screws in the Large Multiscrew Clamp for UNYCO Screws with
±10° of freedom, therefore safe corridors have to be considered in advance for correct and safe screw insertion. Note: Once converging UNYCO screws have been inserted, the
Large Multiscrew Clamps for UNYCO Screws can no longer slide on the screw shafts. It is therefore important to determine the final distance of the fixator from the skin before
inserting the second screw in the clamp unless screws are inserted parallel to each other.
9. UNYCO Screws and UNYCO Cancellous Screws should be selected in accordance with bone type (cortical or cancellous).
10. At the end of surgery, check screw insertion both in the AP and lateral planes, using image intensification.
11. The UNYCO screw may protrude beyond the first cortex or sit close to the insertion point of a nail. In this case pay attention when reaming or inserting a nail at a later stage.
12. Compression is never recommended in a fresh fracture.
13. Particular care should be taken that screws do not enter the joints.
14. The kit is for “single use only’’: therefore
IT MUST NOT BE RE-USED.
15. For more stable fixation of a fracture with a fixator, we recommend that the nearest bone screw is applied fairly close to the fracture margin (a minimum of 1 cm is
recommended) and that these distances are equal on both sides of the fracture.
16. UNYCO Screws and UNYCO Cancellous screws must be applied ONLY by drilling the screw using the Power Drill Torque Limiter (99-93568) inserted into the power drill or
by hand using the Limited Torque Wrench (99-93567). When using the Limited Torque Wrench, it should be held steady so that the direction is maintained throughout the
procedure. During insertion of UNYCO Screws stop drilling when the Power Drill Torque Limiter stops turning and a rattle noise is heard. During insertion of UNYCO Cancellous
Screw stop drilling when its soft tissue reference line reaches the skin or, when the Power Drill Torque Limiter stops turning, whichever comes first. The power drill must be used
at its lowest speed. The Power Drill Torque Limiter (99-93568) is provided in the sterile kit; the Limited Torque Wrench (99-93567) is available upon request. It is mandatory
NOT to apply UNYCO screws in cancellous bone so it is advisable to use always UNYCO Cancellous screws close to the joint.
17. All equipment in the Galaxy UNYCO Diaphyseal Tibia Kit (99-93506) should be carefully examined prior to use to assure proper working condition. If a component or
instrument is believed to be faulty, damaged or suspect, it should NOT BE USED.