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Adverse Effects

None known.
Instructions for Use
1. Inspect the packages and products for damage and expiration date.
If undamaged and unexpired, open the packages and transfer the
Starfish Evo Heart Positioner onto the sterile field utilizing aseptic
technique.
2. Suction circuit hook-up:
a. Attach the tubing (not supplied) from the operating room suction
source to the back of the regulator. Turn the regulator on and set
vacuum to (-)400 mm Hg.
b. Utilizing aseptic technique, connect the tubing from the Starfish
Evo Heart Positioner to the luer connection of the canister tubing
set (Figure 2). Connect the other end of the canister tubing set
to the regulator. Utilize the stopcock on the sterile field to control
the vacuum (on-off) during the procedure.
Note: Canister must be oriented in a vertical position.
Note: Do not fill past the Maximum Capacity line on canister.
3. Attach the device to the retractor (Figure 3).
a. With the clamp lever in the unlocked position, slide open the
mounting clamp.
b. Place the mounting clamp onto the retractor, ensuring the clamp
contact with the retractor is flush.
c. Move the lever to the locked position to secure the clamp to the
retractor. Check that the clamp is securely fastened to the
retractor.
4. Position the turret and arm (Figure 3).
a. Rotate the turret to the desired position.
b. Turn the knob clockwise to tighten the arm. If necessary, turn the
knob counterclockwise to loosen and reposition the arm. The
tension indicator appears red when the arm reaches maximum
tension.
5. Prior to turning on the vacuum, place the positioning head on the apex
or on the left ventricle immediately proximal to the apex. Turn the
stopcock to the on position to activate suction. Position the heart only
after the device has reached its full vacuum of (-)400 mm Hg.
6. Position the heart by holding onto the headlink with one hand while
supporting the heart with the other hand.
7. To disengage the device, support the heart and terminate suction by
turning the stopcock to the off position.
8. When finished, remove the device from the retractor and discard
according to approved hospital procedures.
Instructions for Use
English
11

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