Orthofix Galaxy-TL-HEX, Руководство пользователя

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GALAXY TL-HEX CONNECTING POSTS
Part# Description
93031 Galaxy TL-HEX Connecting
Post L50mm, D12mm
93032 Galaxy TL-HEX Connecting
Post L100mm, D12mm
PQ GTC B 03/19
EN
ORTHOFIX SRL, via Delle Nazioni 9, 37012 Bussolengo (VR) Italy
Tel. 0039 (0) 45 6719000 - Fax 0039 (0) 45 6719380
Important information - please read prior to use
Galaxy - TL-HEX Connection System
93031 Galaxy TL-HEX Connecting Post L50mm, D12mm - 93032 Galaxy TL-HEX Connecting Post L100mm, D12mm
Instructions For Use are subject to change; the most current version of each Instruction For Use is always available online.
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A. The Galaxy - TL-HEX Connection System is compatible with TL, TL-HEX and Galaxy.
B. For important medical information and maintenance consult Instructions for Use PQ TLK, PQ TLH and PQ GAL.
Application of Galaxy - TL-HEX Connection System (Refer to pictures PQGTC1)
1. Apply the TL-HEX ring (full or 5/8) and the Large or the Medium Double Multiscrew Clamp to the bone as described in operative technique GF-1102-OPT, TL-1405-OPT and TL-1001-OPT.
If the connection of the 5/8 ring with the 3/8 ring is envisaged, it is strongly recommended to apply the additional 3/8 ring before tensioning the wires in order to avoid ring deformations that could
impede the procedure completion.
2. Secure the end of the Galaxy TL-HEX connecting Post (length 50mm or 100mm and diameter 12mm; hereinafter “Post”) to the ring in the standard manner with the provided nut. It is recommended
to connect the two Posts to the ring in opposite position with respect to the ring center, as far as possible one from each other. The positions of the Posts may vary depending from ring diameter and wire
placement. The use of the short Post (50mm) is suggested for more stability.
3. Tighten the nut with two wrenches.
4. Place the second Post in the most appropriate position (ideally on the opposite side of the ring) compared to the first Post and the previously assembled frame components. It is necessary to close the
Double Multiscrew Clamp before the positioning of the rod.
5. The Double Multiscrew Clamp and the first Post are connected by a rod of a suitable length and diameter. Tighten the nut of the clamps fully by hand and then with Wrench. If the Large Double Multiscrew
Clamp is used, then a single blue clamp must be used (diameter of the rod is 12mm) and if the Medium Double Multiscrew Clamp is used, then a transition clamp yellow/blue must be used
(diameter of the rod is 9mm).
6. Connect the second Post and the Double Multiscrew Clamp with another rod of a suitable length and diameter and tighten clamps as above.
Optional Additional Step
7. The use of a third Post is optional when using the Large Double Multiscrew Clamp and 12mm rods, whereas it is mandatory in combination with the Medium Double Multiscrew Clamp and 9mm rods.
8. Place the third Post in a central position between the other two.
9. Connect the third Post with a Galaxy Large Clamp and use it as a template to insert the bone screw in the most appropriate direction. Then tighten the Galaxy Large Clamp as described above.
Galaxy - TL-HEX Connection System Final Check (Warning & Precautions)
The Galaxy - TL-HEX Connection System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment.
The safety of the Galaxy - TL-HEX Connection System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
In case TL is the preferred choice, it is necessary to use two rings connected one to each other on the proximal part of the frame as described in operative technique TL-1001-OPT.
Instruments
Part# Description Qty.
54-1154 Wrench, Combo 10mm 2
30017 Allen Wrench 5mm 1
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