Contraindications - Orthofix Galaxy Unyco System Anleitungsfaltblatt

The product is indicated for non-weight-bearing use.

CONTRAINDICATIONS

The Orthofix Galaxy UNYCO System 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
PRECAUTIONS
1. Fracture stabilization has to be done following correct fracture reduction.
2. The arms of the Large Multiscrew Clamp for UNYCO Cancellous 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 Cancellous Screws must be inserted perpendicular to the bone surface using low rotation speed and a steady thrust 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. A cluster of UNYCO Cancellous Screws should never sit across the fracture line. Consider the four screws inserted in the Large Multiscrew Clamp as a cluster as well as the three
screws connected to the Radiolucent Foot Unit.
7. Frame stability must be checked intra-operatively before the patient leaves the operating theatre.
8. If repositioning of UNYCO Cancellous Screw is necessary, re-insert it in a new bone area avoiding any overlap with existing hole.
9. Remember that the first screw determines the position of the remaining screws in the Large Multiscrew Clamp for UNYCO Cancellous Screws with ±10° of freedom, therefore
safe corridors have to be considered in advance for correct and safe screw insertion. Once converging UNYCO Cancellous 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 .
10. UNYCO Cancellous Screws must be applied ONLY by drilling the screw using the Power Drill Torque Limiter (99-93568) inserted into the power drill. Make sure the Power Drill
Torque Limiter is coaxially inserted. During insertion of UNYCO Cancellous Screws stop drilling when the Power Drill Torque Limiter stops turning and a rattle noise is heard. In
cancellous bone stop drilling when its soft tissue reference line reaches the skin or when the Power Drill Torque Limiter stops turning, whichever comes first.
11. All equipment in the Galaxy UNYCO System 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.
12. The fixator should be applied at a sufficient distance from the skin to allow for post-operative swelling and for cleaning, remembering that the stability of the system depends
upon the bone-fixator distance. It is recommended to apply the clamp for UNYCO Screws 4 cm from the skin.
13. In case of knee spanning, stabilization in the femur must be performed with bicortical screws in conjunction with Galaxy Fixation System.
14. If the system is perceived as impediment for application of the definitive treatment, remove the system parts where needed.
15. Meticulous screw site hygiene is required.
16. Do not use components of the Orthofix Galaxy UNYCO System in conjunction with products of other manufacturers, unless otherwise specified, as the combination is not
covered by the necessary validation.
17. It is not allowed to cut UNYCO Cancellous Screws. Do not connect additional clamps to screw shafts.
18. In presence of prosthetic implants or internal fixation, use caution when inserting screws.
19. The Radiolucent Foot Unit must be used with three UNYCO Cancellous Screws.
20. The Large Multiscrew Clamp must be used with four UNYCO Cancellous Screws.
WARNINGS
1 Screw and frame stability should be monitored at regular intervals.
3