Directions For Use - Medtronic STARFISH 2 Instrucciones De Uso

200147_RevE_ch.fm 8/9/04
UC200202762c ML
Size: 3.75" x 8.5" (95.25 mm x 215.9 mm)

Directions for Use

Starfish™ 2 Heart Positioner
Model
29800
Description
The product is a disposable, retractor-based device that incorporates a
silicone suction apparatus, an articulating arm (arm) and a mounting
clamp (see Figure 1). The silicone apparatus is attached to the surface of
the heart by the application of a regulated vacuum (-) 400 mm Hg.
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 for use during coronary artery bypass grafting
operations. The intended function of this product is for positioning the
heart.
Contraindications
This product is not intended for use except as indicated above.
Do not attach device to:
Newly infarcted tissue.
■
■ Aneurysmal tissue.
Directly over a coronary artery.
■
Fragile 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.
The Starfish™ 2 Heart Positioner is to be used only on the apex and on
the left ventricle immediately proximal to the apex.
Do not use on atrial tissue or on the right ventricle.
Always support the heart when re-positioning the heart.
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.
Avoid placing the device directly over a deep sulcus in the epicardial fat
as this may disrupt the vacuum seal and lead to a loss of heart capture.
The product is designed and intended for single use only: DO NOT
RESTERILIZE OR REUSE.
Canister must be oriented in a vertical position.
Do not exceed (-)400 mm Hg of suction.
Do not use this device as a suction source to remove blood from the
operative field.
Do not fill past line on canister.
FULL
Adverse Effects
None known.
200147 Rev E
Medtronic Confidential
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