Registration Information - Medtronic Hancock II Gebrauchsanweisung

9.2. Storage
Store the Hancock II bioprosthesis between 5°C and 25°C (41°F and 77°F). Refrigeration is not required, and
freezing may damage the bioprostheses. Room temperature storage up to 25°C (77°F) is satisfactory provided the
bioprosthesis is not exposed to sunlight or other ultraviolet light sources, or placed where significant temperature
fluctuations may occur.
Maintain appropriate inventory control so that bioprostheses with earlier Use-by dates are implanted first to avoid
expiration dates.
9.3. Return of explanted bioprostheses
Medtronic would like to obtain recovered Hancock II bioprostheses. When determined to be appropriate, explants
will be studied by a consulting pathologist. A written report summarizing the findings will be returned to the
physician. Product return kits, including an explant information form, are available by contacting Medtronic
distribution centers or a Medtronic sales representative. It is important that the explant form is filled out completely.
If a kit is not available, place the explanted bioprosthesis in a container of glutaraldehyde or 10% buffered formalin
immediately after excision. For further instructions on the return of an explanted device, contact a Medtronic sales
representative.
10. Patient information

10.1. Registration information

Note: Patient registration does not apply in countries where patient privacy laws conflict with providing patient
information, including countries from the EU.
A Patient Registration Form is included in each device package. After implantation, please complete all requested
information. The serial number may be found on the package and on the identification tag attached to the retainer.
Return the original form to the Medtronic address indicated on the form and provide the temporary identification
card to the patient before discharge.
An Implanted Device Identification Card is provided to the patient. The card contains the name and telephone
number of the patient's physician, as well as information that medical personnel would require in the event of an
emergency.
11. Postoperative information
11.1. MRI safety information
Nonclinical testing has demonstrated the Hancock II bioprosthesis is MR Conditional. A patient with this device can
be safely scanned immediately after implantation in an MR system meeting the following conditions:
■
Static magnetic field of 1.5 T or 3 T
Instructions for Use English 29