How Supplied; Accessories - Medtronic Open Pivot Gebrauchsanweisung

gently turning the valve handle/holder. Each device size has a specific rotator. If rotating is desired after the
device has been seated and removed from the holder, carefully remove the rotator from the holder by turning
the rotator counterclockwise. The rotator seats properly into the valve orifice when the radial ridge (Figure 2)
on the rotator head is aligned with the straight edge of the leaflets. The rotator head is designed to contact
the flat surfaces of the orifice near the pivot areas. The orifice may be rotated in a clockwise or
counterclockwise direction. After orientation of the valve orifice and leaflets in the patient's annulus, leaflet
mobility may be determined with the blue leaflet actuator.
Caution: Use only the rotator supplied with the device. Do not use any other instrument to rotate the valve.
Use of instruments other than those provided may cause damage to the orifice and leaflets and may result
in valve malfunction.
7. Postoperative Information
7.1. Anticoagulation
The medical literature indicates that patients with mechanical heart valves should be routinely maintained
on anticoagulants to reduce the risk of valve thrombosis and thromboembolism.
7.2. Magnetic Resonance Imaging (MRI) Testing
The AVG was determined to be MR-conditional according to the terminology specified in the American
Society for Testing and Materials (ASTM) International, Designation: F2503-05. Standard Practice for
Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM
International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, Pennsylvania, 2005.
Nonclinical testing demonstrated that the AVG is MR Conditional. A patient with this device can be scanned
safely immediately after placement under the following conditions:
7.3. Static Magnetic Field
■
Static magnetic field of 3 Tesla or less
■ Maximum spatial gradient magnetic field of 720 Gauss/cm or less
7.4. MRI-Related Heating
In nonclinical testing, the AVG produced the following temperature rise during MRI performed for 15 minutes
in the 3 T (3 T/ 128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR
system: Highest temperature change: +1.6°C.
Therefore, the MRI-related heating experiments for the AVG at 3 T using a transmit/receive RF body coil at
an MR system reported whole body averaged SAR of 2.9 W/kg (ie, associated with a calorimetry measured
whole body averaged value of 2.7 W/kg) indicated that the greatest amount of heating that occurred in
association with these specific conditions was equal to or less than +1.6°C.
7.5. Artifact Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to
the position of the AVG.
Pulse Sequence
Signal Void Size
Plane Orientation
Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be
necessary.

8. How Supplied

8.1. Packaging
The AVG is packaged and sterilized in a transparent double barrier container. The aortic valve is premounted
on a holder attached to a handle/rotator. All package labeling is color-coded blue. The handle/rotator
accessories are color coded green to identify the aortic valve.
The valve package (Figure 1) includes:
■
Outer Tray
■
Inner Container
■
Aortic Valved Graft, Valve Holder, Handle/Rotator Assembly
■
Instructions for Use
■
Patient Registration Form
■
Green Leaflet Actuator
All packaging material is recyclable. Manage disposal in accordance with local statutory regulations.
8.2. Storage
For maximum protection and product identification, it is recommended that the valve be stored in its original
packaging. The storage environment should be clean, cool, and dry, the sterility and nonpyrogenicity of the
valve is validated to remain unaffected until the Use By date printed on the product, provided the seals and
containers are not opened or damaged.
8.3. Returned Product Information
For detailed information on the Medtronic Return Product Policy, please contact your local representative.

9. Accessories

A green color-coded rotator is included with each AVG (Figure 2). Only use the rotator that is supplied in the
package. The rotator supplied is matched to the valve size.
10 Instructions for Use
T1-SE T1-SE
1,213 mm 2 486 mm
Parallel Perpendicular
English
GRE
2 2,189 mm
Parallel
GRE
2 1,369 mm 2
Perpendicular