On-X On-X Aortic Heart Valve and Extended Holder Скачать руководство пользователя

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Prosthetic Heart Valve

Instructions for Use
English

On-X

Aortic Heart Valve with Standard Sewing Ring - REF ONXA

On-X

Mitral Heart Valve with Standard Sewing Ring - REF ONXM

On-X

Aortic Heart Valve with Conform-X

Sewing Ring - REF ONXAC

On-X

Mitral Heart Valve with Conform-X

Sewing Ring - REF ONXMC

On-X

Aortic Heart Valve with Anatomic Sewing Ring - REF ONXAN

On-X

Aortic Heart Valve and Extended Holder - REF ONXAE

On-X

Aortic Heart Valve with Conform-X

Sewing Ring and Extended Holder - REF ONXACE

On-X

Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder - REF ONXANE

On-X

Содержание On-X Aortic Heart Valve and Extended Holder

Страница 1: ...eart Valve with Conform X Sewing Ring REF ONXAC On X Mitral Heart Valve with Conform X Sewing Ring REF ONXMC On X Aortic Heart Valve with Anatomic Sewing Ring REF ONXAN On X Aortic Heart Valve and Ext...

Страница 2: ...SSMENT AND VALVE ROTATION 11 9 7 VALVE ORIENTATION 12 10 POSTOPERATIVE INFORMATION 12 10 1 MAGNETIC RESONANCE IMAGING MRI COMPATIBILITY 12 10 2 RETURNED GOODS 12 11 PATIENT INFORMATION 12 11 1 PATIENT...

Страница 3: ...eplica sizers verify the aortic valve 10 Figure 12 Supra annular valve positioning 11 Figure 13 Sewing ring cross sections 11 Figure 14 Removing the valve holder 11 Figure 15 Insert valve rotator 12 F...

Страница 4: ...a travel arc of 50 to the closed position The orifice is composed of graphite substrate coated with On X Carbon a pure unalloyed form of pyrolytic carbon The leaflets consist of On X Carbon deposited...

Страница 5: ...esis regurgitation prosthesis structural dysfunction prosthesis thrombosis stroke thromboembolism It is possible that these complications could lead to reoperation explantation permanent disability de...

Страница 6: ...rded on the outer package label Appropriate inventory control should be maintained so that prostheses with earlier expiration dates are preferentially implanted and expiration is avoided To protect th...

Страница 7: ...YES Intrasupra annular 23 Aortic Cylindrical YES Intrasupra annular 25 Aortic Cylindrical YES Intrasupra annular 27 29 Aortic Conical YES Intra annular 19 Aortic Conform X Cylindrical YES Intrasupra...

Страница 8: ...n and Resterilization The On X Prosthetic Heart Valve is provided sterile If the sterility expiration date has passed or if upon removal from the outer box the valve container is damaged or the steril...

Страница 9: ...the patient or place it in the patient s records Figure 7a Twist off outer lid Figure 7b Remove by pull tab Figure 7c or invert on sterile field 4 Open the outer container Twist off outer lid package...

Страница 10: ...thetic Heart Valve sizers when sizing the annulus Sizers contain cylindrical conical and aortic replica ends Refer to Table 2 to facilitate sizer selection Cylindrical sizers correspond to the valve s...

Страница 11: ...mplanted using a pledgetted or non pledgetted everting mattress suture technique although non everting and continuous suture techniques have also been used with success CAUTION When seating the valve...

Страница 12: ...e to rotation is encountered The torque required to rotate the valve in situ should be about the same as that required when testing rotation before implantation If noticeably greater torque is require...

Страница 13: ...mplete the card and carry it with them at all times 11 3 Patient Information Booklet On XLTI has made available a patient information booklet that the physician may choose to provide to the patient pr...

Страница 14: ...s in an international multicenter prospective non randomized study with retrospective controls Patients requiring isolated mitral heart valve replacement were enrolled from 1996 to 2001 at 16 centers...

Страница 15: ...d as linearized rates based on total patient years 3 Freedom from event was calculated based on the method of Kaplan Meier SE Standard Error 4 n number of patients in each category N total number of s...

Страница 16: ...3 0 7 99 0 0 7 99 0 0 7 Explant 1 0 4 3 0 7 98 0 1 0 98 0 1 0 Hemolysis5 0 0 0 0 0 0 100 0 0 100 0 0 Hemorrhage6 all 4 1 8 6 1 4 96 4 1 3 94 4 2 0 Hemorrhage major 4 1 8 2 0 5 97 0 1 2 97 0 1 2 Periv...

Страница 17: ...tis 18 7 8 Gastroinestinal Ulcer 18 7 8 Chronic Kidney Failure 13 5 6 Carotid Artery Disease 12 5 2 Coronary Artery Bypass Graft 10 4 4 Cancer 10 4 4 Previous Mitral Valve Replacement 9 3 9 Cardiomyop...

Страница 18: ...ts followed reproduced from Figure 2 Nd number of patients for which NYHA data were collected not including missing 3 n number of patients in each category 4 Undetermined means data were collected but...

Страница 19: ...2 0 4 3 Regurgitation Nd 20 Nd 37 Nd 68 Nd 36 Nd 25 n n Nd n n Nd n n Nd N n Nd n n Nd 0 5 25 0 9 24 3 27 39 7 17 47 2 7 28 0 1 2 12 60 0 25 67 6 37 54 4 16 44 4 17 68 0 3 2 10 0 0 0 0 3 4 4 2 5 6 1 4...

Страница 20: ...Bldg B Austin Texas 78752 U S A TEL 512 339 8000 FAX 512 339 3636 WEB www onxlti com EMAIL onx onxlti com CryoLife Europa Ltd Bramley House The Guildway Old Portsmouth Road Guildford Surrey GU3 1LR Un...

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