Medtronic ML-0714 Instructions for Use
GENERAL STERILIZATION AND CLEANING INSTRUCTIONS
Quality Statement
TeDan Surgical Innovations’, LLC (TSI) dedication to delivering state of the art surgical
retractor systems has allowed TSI to become the leader in an ever advancing medical
industry. TSI strives to meet our customer needs and market demands in a timely manner
through our experienced and innovative management team.
Warranty
All reusable products oered by TeDan Surgical Innovations, LLC, are guaranteed by
a Lifetime Warranty against defects in materials and workmanship from the date of
purchase. TSI’s Lifetime Warranty does not cover damages caused by normal wear, failure
to follow instructions, misuse and products that have been repaired or modied in ways
not approved by TSI. Prepackaged sterile products are warranted to be free from defect
until expiration date. Any product that proves to be defective during this period will
be repaired or replaced at no charge. TeDan Surgical Innovations, LLC shall not be held
responsible for consequential or indirect damage arising from the sale or use of any
product.
Please note:
• The color of TSI’s Titanium and Aluminum instruments may vary due to the
anodizing process or alloy used. Shading or loss of color may also occur after
sterilization. This is not a defect in the instrument or material and will not aect
the performance of your high quality TSI
instrument.
• When loosening, do not force the knob
of the articulating arm past the stop.
Doing so could damage the ball joint and
aect the rigidity of the articulating arm
(Figure 1).
• Do not over turn the pivoting mechanism
located on the retractor frames. Forcing
the pivoting mechanism past stop may
cause damage to the device (Figure 2).
The procedure tested by TSI should be used for sterilization and cleaning. A hospital may
choose to follow another procedure in the event that the procedure is validated. In either
case, the eectiveness of the procedure should be established. TSI utilized biological
indicators to establish the eectiveness of the procedure. Other methods can be found in
ISO 17665-1:2006 Standard.
Cleaning Instructions:
Please note in preparation of cleaning:
1. Automated cleaning is not suitable for instruments with long lumens, ball joints, or
stainless steel cables (e.g. suction tubes, surgical arms and exible surgical arms).
Such instruments should undergo a manual cleaning prior to sterilization.
2. When applicable, instruments should be cleaned in the open or unlocked position.
3. Flexible Arms: Turn tightening knob counter-clockwise to loosen the internal cable
to enable movement of the surgical arm beads to allow uid to ow between
each link prior to placing arm in sonicator. Articulating Arms: Turn tightening knob
clockwise to tighten ball joint prior to placing arm in sonicator.
4. Black coated and color anodized components may be negatively aected if
aggressive cleaning mediums or appliances (e.g. extreme acidic/alkaline, abrasives)
are used. A pH neutral cleaner, which may or may not contain enzymes, (such as
Prolystica manufactured by STERIS Corp.) is recommended. Exposure to chlorides
or hydrogen peroxide may negatively aect the coating or colorization of the
components.
Manual cleaning instructions:
1. Rinse each instrument individually with a steady stream of tap water until gross
contaminants are removed. Depending on the complexity of the device, this
process should take approximately 1-2 minutes.
2. Place each instrument into a sonicator containing an enzymatic, pH neutral
detergent solution prepared according to the manufacturer’s instructions and
Figure 1 Figure 2
TSI-0101001 1
© 2017 TEDAN SURGICAL INNOVATIONS/ Rev11
www.tedansurgical.com
sonicate for 10 minutes.
3. Prepare a wash solution using an enzymatic, pH neutral detergent, in a wash
container with tap water using the concentration recommended by the detergent
manufacturer.
4. Transfer each instrument to a manual wash container and fully immerse in the
cleaning solution prepared in Step 3.
5. While still submerged, any visible contamination and debris should be removed
by scrubbing each instrument with an appropriately-sized soft nylon bristle brush
until visibly clean, paying particular attention to hard-to-clean areas such as
crevices and joints. Depending on the complexity of the device, this process should
take approximately 1-2 minutes.
Using an appropriately sized syringe, ush cannulations at least three times with
50mL of cleaning solution each time. See below for additional instrument specic
instructions.
a. For shafted instruments with cannulae, ush with cleaning solution
by inserting the ushing cannula and attaching an appropriately sized
syringe lled with cleaning solution.
b. For applicable instruments, such as Suction Tubes, insert the supplied
mandrel into the suction tube lumen to dislodge potentially trapped
debris.
c. For ex arms, turn the tightening knob counter-clockwise to loosen the
internal cable to enable movement of the surgical arm beads to allow uid
6. Rinse each instrument with deionized water for 30-60 seconds.
7. Dry each instrument using clean, absorbent, low lint wipes to remove excess rinse
Automated cleaning instructions:
Use only washer/disinfector machines that have been validated in accordance with ISO
15883.
1. Perform pre-cleaning to remove gross contaminants as follows:
2. While still submerged, remove visible soil by scrubbing with an appropriately sized
3. Rinse with owing deionized water for a minimum of 30 seconds for each
4. Load instruments into washer/disinfector in accordance with the manufacturer’s
5. Arrange instruments with curved surfaces and cannulations facing downward to
6. Operate the washer/disinfector cycle according to the manufacturer’s instructions.
Recommended minimal washer/disinfector parameters:
• Heated wash at 140°F (60°C) for 2 minutes
• Heated tap water rinse at 140°F (60°C) for 20 seconds
• Heated deionized water rinse at 180°F (82°C) for 1 minute
• Forced air drying at 240°F (116°C) for 9 minutes
Surgical arm inspection before use:
Articulating Arms
1. Inspect entire assembly for damage.
2. Hold arm assembly at column and turn central tightening knob clockwise.
3. Check to make sure that arm is rigid at all three joints.
4. Insert arm column into table clamp, turn column tightening lever clockwise and
Flexible Arms
1. Inspect entire assembly for damage.
2. Turn the ex arm tightening knob clockwise and ensure the arm is suciently rigid
to ow between each link.
water.
a. Prepare a wash solution using a pH neutral detergent, in a wash container
with tap water using the minimum concentration recommended by the
detergent manufacturer.
b. Submerge and soak in wash solution for a minimum of 1 minute.
c. Flush any cannulations that may be present two times with 50 ml of
cleaning solution each time.
soft nylon bristle brush for a minimum of 4 minutes until no visible soil is observed.
instrument.
instructions.
prevent pooling of water.
ensure that it holds securely.
© 2017 TEDAN SURGICAL INNOVATIONS/ Rev11
www.tedansurgical.com
TSI-01010012