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Product Description:
The TeDan Surgical Innovations, LLC (TSI) Sterile Light Cable (ML-0046) is supplied sterile in
individual sterile pouches and 5 pouches per box.
Intended Use:
The TSI Sterile Light Cable (ML-0046) is intended for use only with our retractor blades and our
Light Sources (ML-0050 & ML-0051) to illuminate the surgical field. The Sterile Light Cable is
specifically designed to angle light into the surgical wound.
Instructions for use:
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1. Inspect package prior to use and do not use if the package is damaged or sterility has
been compromised.
2. Remove the Light Cable from the sterile packaging.
3. Plug the end of the Sterile Light Cable into the 24W Metal Halide TSI Light Source (ML-0050)
or the LED TSI Light Source (ML-0051).
4. Once the Sterile Light Cable is plugged in to the light source, open the light source shutter
to confirm that the Sterile Light Cable is transmitting light. Once confirmed, close the light
source shutter. The light source shutter must remain closed until the Sterile Light Cable is
plugged into the retractor blades.
5. Choose the desired length blades from the Retractor Set and gently insert the bifurcated end
into the holes located on top of the retractor blades.
6. Open the light source shutter and confirm that the Sterile Light Cable is transmitting light.
The light source can remain on once the Sterile Light Cable is inserted into the retractor
blades.
7. The attenuator on the Light Source (ML-0050 or ML-0051) may be adjusted to provide the
amount of light preferred.
8. Close the light source shutter prior to removing the Sterile Light Cable from the retractor
blades. The light source shutter must remain closed until the light source power is turned off.
9. Once the surgical procedure is completed, dispose of the disposable Light Cable in
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accordance with approved hospital practices.
Warning/Precautions:
1. CAUTION: US Federal law restricts this device to sale by or on the order of a physician.
2. Do not reuse. For single use only. Reuse of single-use devices creates a potential risk of
patient or user infections. Contamination of the device may lead to injury, illness or death of
the patient.
3. Only use with TSI Light Source (ML-0050 or ML-0051).
4. The light source shutter must remain closed until the Sterile Light Cable is inserted into the
TeDan retractor blades.
5. Place the light source away from items that are flammable.
6. Do not place the Sterile Light Cable that is connected to the light source on drapes, sponges,
or anything else that is flammable.
7. Do not allow the Sterile Light Cable that is connected to the light source to hang over the
side of the sterile field if the light source is on.
8. When performing a procedure that requires only a single lighted blade, use only TSI Item
#ML-0047, Phantom Light Cable, Single Ended with TeDan Connector.
TSI-0202030
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© 2016 TEDAN SURGICAL INNOVATIONS/ Rev4
www.tedansurgical.com
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