Orthofix Ltd
TrueLok Wire Tensioner Instructions for Use
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PQWTN F 03/21 (0421217)
EN
Instructions For Use are subject to change; the most current version of each Instruction For Use is always available online.
Important information - please read prior to use. See also instruction leaflet PQTLK for the TrueLok™ Systems and PQRMD for reusable medical devices. Keep this leaflet: you may need to read it again
TrueLok WIRE TENSIONER (54-1139)
Manufacturer name ORTHOFIX SRL, via Delle Nazioni 9, 37012 Bussolengo (VR) Italy Tel. 0039 (0) 45 6719000 - Fax 0039 (0) 45 6719380
1) The Wire Tensioner (54-1139) allows tensioning wires up to 130kg. An indication of the applied tension can be read from a scale (fig. 1).
Figure 1 2) Only when tensioning 1.5mm diameter wires, apply the specific Tension Limiter (54-1141) to physically limit the applied tension to 90kg. Make sure to insert the Tension Limiter correctly, paying attention to the laser mark (fig. 2).
Figure 2 3) To exchange the different types of Wire Tensioner Tips, remove the Wire Tensioner’s Tip by loosening the locking set-screw with the hex-driver (52-1018) (fig. 3). Do not remove the locking set-screw for any reason.
20116735
54-1151 54-1152
20116736
54-1251 54-1252
54-1151 54-1152
20116731 Figure 3
54-1251 54-1252
4) Using appropriate tools thoroughly clean the whole cannulation (fig. 4) to remove any debris that might be present. Additional information on cleaning and reprocessing can be found in the leaflet PQRMD.
Figure 4 5) Apply one drop of medical grade lubricant on moving elements when needed. NOTE: Products that show excessive fading of marked product code and lot, thus preventing clear identification and traceability, must NOT BE USED.
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All Orthofix internal and external fixation products should be used together with their corresponding Orthofix implants, components and accessories. Their application should be performed with the specific Orthofix instrumentation, following carefully the surgical technique recommended by the manufacturer in the appropriate Operative Technique Manual.
Description
Symbol
Medical Device Consult instructions for use or consult electronic instructions for use
Caution: Consult instructions for use for important cautionary information
Single Use. Do not re-use
Orthofix note: discard appropriately after the use (treatment) on patient Sterile. Sterilised by irradiaton Non-sterile Double sterile barrier system
Catalogue number
Batch code Use-by date (year-month-day)
0123
CE marking in conformity to applicable European Medical Device Directives/Regulations Date of manufacture
Manufacture
Do not use if package is damaged and consult instructions for use Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
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