Directions For Use - Medtronic STARFISH NS HP102 Gebrauchsanweisung

Directions for Use

Starfish™ NS Heart Positioner
Model
HP102
Description
This product consists of 6 single-use, disposable components:
Flex-arm
■
Handle/shaft
■
Suction head
■
Tunneling tip
■
Wrench
■
Canister tubing set
■
Note: A reusable mounting rail is sold separately. It is secured to the
surgical table rail with a standard table rail clamp (not included). See
Figure 1.
The product is a disposable device that utilizes a detachable silicone
suction apparatus and vacuum pressure to position the beating heart.
Sterile, Nonpyrogenic, Disposable, Single use only.
Indications for Use
The Starfish™ NS Heart Positioner is intended to enable manipulation of
the beating heart in cardiac surgery procedures that utilize a thoracotomy
of at least 4 cm for access.
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™ NS Heart Positioner is to be used only on the apex and on
the left ventricle immediately lateral to the apex.
Do not use on atrial tissue or on the right ventricle.
Do not attempt to insert shaft in thoracic cavity without tunneling tip
attached.
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 the canister.
FULL
Directions for Use English 9