Adverse Effects - Medtronic STARFISH NS HP102 Gebrauchsanweisung

Adverse effects

None known.
Directions for Use
1. Inspect the packages and products for damage and expiration date. If
undamaged and unexpired, open the packages and transfer the
Starfish™ NS Heart Positioner onto the sterile field utilizing aseptic
technique.
2. Set regulated vacuum to (-) 400 mm Hg. Utilizing aseptic technique,
connect the tubing from the Starfish™ NS Heart Positioner to the luer
connection of the canister tubing set (see Figure 2). 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.
Note: Canister must be oriented in a vertical position.
Note: Do not fill past
3. Secure mounting rail to the surgical table rail clamp and insert flex-arm
turret post into the mounting rail. Secure the flex-arm in the mounting
rail by tightening the knob on the mounting rail.
4. Use the wrench to securely tighten the tunneling tip onto the end of the
shaft.
5. Make an incision for the insertion of the shaft and tunneling tip.
6. Under video assistance, insert shaft and tunneling tip into the thoracic
cavity.
Warning: Do not attempt to insert shaft into the thoracic cavity without
the tunneling tip attached.
7. Advance shaft to externalize the tunneling tip through the thoracotomy
(minimum 4 cm) and remove the tunneling tip.
Note: Keep tunneling tip and wrench within the sterile field. The
tunneling tip will be placed back onto the shaft prior to removing shaft
from thoracic cavity.
8. Use the wrench to securely attach the suction head to the shaft.
9. Prior to turning on the vacuum, place the suction head on the apex or
on the left ventricle immediately lateral to the apex. Turn the suction on
by turning the stopcock to the "ON" position. Position the heart only
after the device has reached full vacuum ((-) 400 mm Hg).
10. Snap the end of the flex-arm onto the handle.
11. Gently position the heart to expose the targeted tissue to the operative
view.
12. When the desired position is obtained, tighten the whale tail on the
flex-arm to immobilize the turret and articulating links and to fixate the
Starfish™ NS Heart Positioner in its desired position.
13. To disengage device, loosen the whale tail on the flex-arm and place
the heart in the anatomical position and terminate suction by turning
the stopcock to the "OFF" position.
14. Remove the flex-arm from the mounting rail and the handle of the
Starfish™ NS Heart Positioner.
15. Advance shaft to externalize suction head. Using the wrench, replace
the suction head with the tunneling tip.
16. Remove the device from the thoracotomy and discard according to
approved hospital procedures.
The Following Disclaimer Of Warranty Applies To United States
Customers Only:
Le déni de garantie ci-après vaut uniquement pour les clients des Etats-
Unis : / Der nachfolgende Haftungsausschluß gilt nur für Kunden in den
Vereinigten Staaten: / La siguiente renuncia de responsabilidad se aplica
sólo a los clientes de los Estados Unidos: / De volgende uitsluiting van
garantie geldt uitsluitend voor klanten in de Verenigde Staten: / La
seguente esclusione dalla garanzia è valida solo per i clienti negli Stati
Uniti: / Seuraava takuun vastuuvapauslauseke koskee vain Yhdysvaltojen
asiakkaita: / Nedanstående friskrivning från ansvar är endast tillämplig på
kunder i USA: / H ακόλουθη παύση ισχύος της εγγύησης ισχύει µόνον για
πελάτες εντός των Hνωµένων Πολιτειών: / Nedenstående
10 English
line on canister.
FULL
Directions for Use