Overview of SynCardia CardioWest™
TAH‑t Training
The start-up training is conducted in four primary phases
that are generally described as follows:
Phase I - Training for implant team members at a SynCardia
Training Center. The training involves an animal implant procedure, lectures,
orientation to the patient simulator, and rounds on TAH‑t patients (if available.)
Phase II - Training is continued at the trainee implant
hospital to prepare the implant team for the first on-site TAH‑t implant
and to certify the hospital as implant-ready. CSS Consoles and the patient simulator
are shipped to the implant center prior to this phase, so the implant team can
practice and train other team members who may not have been present at Phase I
training.
Phase III - Proctored training during the first human
TAH‑t implant performed at the trainee hospital.
Phase IV (Europe Only) - Training includes supervision
of the transfer of a suitable stable patient within the hospital to a portable
driver from the Big Blue drive. The hospital's staff is also trained on patient
discharge procedures with the portable driver.
The members of the implant team will be assigned one
or more of the following areas of responsibility:
(1) implant surgery (surgeons)
(2) surgery support (scrub nurse or physicians assistant, perfusionist or anesthesiologist)
(3) anticoagulation (hematologist, pharmacist or anesthesiologist)
(4) driver support (biomedical engineer, device coordinator or perfusionist)
(5) post-operative patient management (ICU nurse, nurse trainer, or device coordinator)
(6) heart failure cardiology (intensivist or cardiologist)
The implant team roster must indicate
which areas of functional responsibility are assigned to each implant team member
for mastery along with a complete curriculum vital for each member.
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