Contraindications; Adverse Effects - Medtronic OCTOPUS 4 Gebrauchsanweisung

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2008/MAY/21 at 2:50 p.m. Doc number: M931091A001 Rev. A [0YO]
Instructions for Use
OCTOPUS 4/4.3 Tissue Stabilizer
Model
29400, 29403
Description
The product is a disposable, retractor-based stabilizer that consists of two
tissue stabilizers attached to an articulating arm (arm). The arm fastens
to a retractor by use of a mounting clamp. A stopcock provides on-off
control of suction (Figure 1 and Figure 2). With the tissue stabilizers
placed on either side of the anastomotic site, suction is applied to stabilize
the tissue. The arm is tightened and loosened by the knob. As the arm
tightens, the tissue stabilizers spread in an arc fashion.
Sterile, Nonpyrogenic, Disposable, Single use only.
Note: The mounting clamp has been designed to be compatible with most
adult median sternotomy retractors. Retractor compatibility should be
confirmed prior to beginning the procedure.
Indications
This product is intended to stabilize and minimize the motion of selected
areas of the beating heart during cardiac surgery.

Contraindications

This product is not intended for use except as indicated above. Do not
position the tissue stabilizers over a coronary artery, newly infarcted or
aneurysmal heart tissue.
Warnings
Patient and procedure selection is the responsibility of the medical
professional and the outcome is dependent on many variables, including
patient anatomy, pathology and surgical techniques.
Precautions
Caution: Federal law (USA) restricts this device to sale by or on the order
of a physician.
The directions for use are furnished for information purposes only.
The product is designed and intended for single use only: DO NOT
RESTERILIZE OR REUSE.
The initial spacing between the right and left tissue stabilizers is important
for optimal performance. The initial spacing between the tissue stabilizers
will affect stabilization and tension on the tissue and should be chosen at
the surgeon's discretion.
Canister must be oriented in a vertical position.
Do not fill past the Maximum Capacity line on canister.
Do not exceed (-)400 mm Hg of suction.

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
tissue stabilizer onto the sterile field utilizing aseptic technique.
2. Suction circuit hook-up:
a. Attach tubing (not supplied) from the operating room suction
source to the back of the regulator. Turn regulator on and set
vacuum to (-) 400 mm Hg.
b. Utilizing aseptic technique, connect the tubing from the tissue
stabilizer to the luer connection of the canister tubing set
(Figure 3). Connect other end of canister tubing set to the
regulator. Utilize the stopcock on the sterile field to control
vacuum (on-off) during the procedure.
10 Instructions for Use English