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950000-001 Rev. 004

SynCardia Systems Inc.

temporary Total Artificial

Heart (TAH-t)

INSTRUCTIONS FOR USE

1992 E. Silverlake Road
Tucson, AZ 85713 USA
(520) 545-1234
(866) 771-9437

STERILE EO

0086

16 MAY 2005

CAUTION: Federal (USA) law restricts this device to sale by
or on order of a physician.

Содержание TAH-t

Страница 1: ...temporary Total Artificial Heart TAH t INSTRUCTIONS FOR USE 1992 E Silverlake Road Tucson AZ 85713 USA 520 545 1234 866 771 9437 STERILE EO 0086 16 MAY 2005 CAUTION Federal USA law restricts this devi...

Страница 2: ...Procedures 10 7 1 Materials Needed but not Provided 10 7 2 Preparation 11 7 3 Removal of Native Ventricles 11 7 4 Preparing the Atria 13 7 5 Outflow Connectors 15 7 6 Connect Artificial Ventricles 16...

Страница 3: ...tificial ventricle to fill and then eject blood when compressed by air from the external console Mechanical valves mounted in the inflow 27mm and outflow 25mm ports of each artificial ventricle contro...

Страница 4: ...r electrical supply The controller is the major component of the external console and supplies pulses of pneumatic pressure to the right and left drivelines which connect into the air chambers of the...

Страница 5: ...cardiomyopathies has not been established 6 Do not use this device if the implantable artificial ventricles cannot fit in the chest area vacated by the natural ventricles Inferior vena cava and left...

Страница 6: ...fibinolitic agent like Aprotinine or Amicar with an active clotting agent like FEIBA 5 Use only water soluble antiseptic cleaners around the exit site Ointments may delay tissue in growth into the dri...

Страница 7: ...l insertion of a VAD through the left ventricle 10 failure to wean from cardiopulmonary bypass with bi ventricular injury 4 left right ventricular or mural thrombus 3 or septal defect 3 All patients w...

Страница 8: ...s During Device Implantation in Decreasing Order of Frequency Represents 17 6 years or 6411 days on the device Adverse Event Number of Events Number of Patients n 81 Any Adverse Event 400 76 93 8 Infe...

Страница 9: ...as initiated using three TAH t units which had expired their 3 year sterilization expiration date This provided information about the effects of long term storage on the fatigue resistance properties...

Страница 10: ...rin After exposure to the blood approx 30 cc for each connector each time stretch connector let dry for about 5 minutes and preclot again The connectors are coated on the outside with biologic glue cr...

Страница 11: ...way to clot 7 3 Removal of the Native Ventricles Cannulation of the aorta and both superior and inferior vena cava is done in a standard fashion Umbilical tape chokers are used on the cavae Dissection...

Страница 12: ...rimmed away and a 2 mm edge of valve tissue along with the annulus is left intact The atrial cuff generally extends 1 cm beyond the AV valves and consists of residual ventricular muscle and fat in the...

Страница 13: ...erative field while the SynCardia TAH t is implanted 7 4 Preparing the Atria The outer walls of the entire right and left atrial cuff complex are encircled with Teflon felt buttresses These are placed...

Страница 14: ...position Figure 5 Figure 5 Inflow connector inverted for suturing left finished normal position right Check for hemostasis with the plastic leak tester made to fit within the inflow connector A syrin...

Страница 15: ...s is made with a running 4 0 polypropylene suture in an end to end fashion beginning with lateral wall and running the back wall of the anastomosis from the inside Figure 6 Figure 6 Outflow Connector...

Страница 16: ...ial left ventricle is placed within the connector and the operator pulls with the Mayo clamps and pushes the artificial left ventricle into the inflow connector The position in which the heart sits fo...

Страница 17: ...pulmonary outflow connection is made again taking care not to twist Before connecting the pulmonary outflow connector graft the chokers on the superior and inferior vena cava should be removed This al...

Страница 18: ...ring together the edges of the Gortex sheets to form a tent or neo pericardium Take care to make a loose fit without impingement upon the cavae and tension on the device Prior to closure of the cephal...

Страница 19: ...SynCardia TAH t Instructions for Use SynCardia Systems Inc Page 19 Figure 9 Solution to a Fit Problem...

Страница 20: ...and console replacement Specifications Describes the SynCardia TAH t physical and performance specifications Routine Maintenance and System Checkout Describes console checkout batteries cleaning and c...

Страница 21: ...wo consoles should be in ready standby mode Ensure that backup batteries are fully charged Verify that each system has been connected to AC power with the SYSTEM POWER switch in the ON 1 position Conf...

Страница 22: ...VACUUM are zero Turn primary CONTROLLER key switch On and press controller ALARM RESET button Turn ALARM SYSTEM key switch to ON Mute console hardware alarms until LDP 90 mmHg and RDP 20 mmHg Verify...

Страница 23: ...m Remove key from the primary controller key switch before moving patient Pneumatic drive ejection pressures should be set to achieve full ejection Pressure tracings on the monitoring computer can be...

Страница 24: ...and the SynCardia TAH t is turned off The artificial ventricles are separated from the atrial inflow cannula The great vessels outflow connectors are amputated at the level of the connector great vess...

Страница 25: ...t plug outflow pressure test plug locking ties and 2 de airing needles all sterile All sterile components are packaged in double aseptic transfer packages Surgical Spares Kit Part 500177 Sterile Conta...

Страница 26: ...an average device output of 6 5 7 5 LPM should be achieved with a CVP of 8 12 mmHg The SynCardia TAH t is specified for patients with body surface areas of at least 1 7 m At a cardiac index of 2 5 l m...

Страница 27: ...sitive ASA is started at 81 mg per day The dipyridamole is adjusted according to the results of Platelet Factor 4 and Beta Thromboglobulin If these tests are elevated the platelets are very active and...

Страница 28: ...stem Overview 3 Implant Procedures 4 Operation of the console 5 Explant Procedures 6 Patient Management 7 Summary of Clinical Studies 8 Animal Procedure a minimum of one implant needs to be performed...

Страница 29: ...st requirements of ISO 10993 Biological Evaluation of Medical Devices SynCardia TAH t Patient Contacting Materials Matrix Component Material Ventricle and diaphragm Segmented polyurethane Nylon Inflow...

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