Tedan UL-0360S-05 Mode D'emploi page 3

3. Using a TSI Screwdriver (such as ML-0055), first insert and then screw
until seated. The Phantom ATP Sterile Screw should go through a
Phantom UL Blade Cannulation.
4. Remove the screwdriver.
5. Repeat steps 1 through 4 if a second Phantom ATP Sterile Screw is
desired. Only one screw per cannulated blade is recommend.
6. The above procedure ensures correct placement of the screws. Do not
bend the screws as this may cause failure of the screw.
7. Remove the Phantom ATP Sterile Screws after use with a TSI Screwdriver
(such as ML‐0055).
8. TSI Phantom ATP Sterile Screws are single use only products. After the
procedure, dispose of the screws in an approved sharps container.
9. If needed, the screw or any fragment thereof can be located by means
of an X Ray.
Reporting Serious Incidents:
Any serious incidents that has occurred in relation to the device should be
reported to TSI and the Competent Authority of the Member State in which the
user and/or patient is established. Adverse events and incidents can be reported
to TSI per contact information on the device packaging.
Warning/Precautions:
1. CAUTION: US Federal law restricts this device to sale by or on the order
of a physician.
2. This product is supplied STERILE and Single Use Only. Do not reuse.
Reuse may compromise the structural integrity of the device and/or
lead to device failure. Reuse also presents biological hazards associated
with disease transmission and immune/allergy issues, some of which
could cause severe illness or be fatal.
3. Do not bend the screws as this may cause failure of the screw.
4. The decision to use Phantom ATP Sterile Screws is based upon
suitability of the patient's bone condition.
5. Phantom ATP Sterile Screws are only compatible with TSI screwdrivers.
6. Do not use this device for any purpose other than the stated intended
use.
7. Potential Adverse Events / Residual Risks: Infection / Adverse Reaction,
Delay in Surgery, Injury.
8. Use of this instrument for any purpose, or in any manner other than
those described here may cause instrument damage or failure which
could result in serious patient injury or death. If needed, all TSI metal
products or fragments thereof can be located by means of an X-Ray.
9. TSI Phantom ATP Sterile Screws are for use only with the TeDan
Phantom UL Retractor system and may not be used with other
manufacturer's products.
Sterilization and Shelf Life:
Phantom ATP Sterile Screws are STERILE single use only and are sterilized by
ethylene oxide. They may not be re-sterilized or re-used. Sterile packages have a
five (5) year shelf life and should be stored at room temperature.
See www.tedansurgical.com/symbolsglossary for the Symbol Glossary.
TSI-0102008 © 2022 TEDAN SURGICAL INNOVATIONS/ Rev01
www.tedansurgical.com
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