SynCardia Companion 2 Driver System, Руководство оператора

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SynCardia Systems, LLC
Companion 2 Driver System Operator Manual
Page 20 of 132
touch screen. This is performed through driver touch screen calibration
procedure (see
Section 8.1.10 ).
4.14 Always keep the Companion 2 Driver System away from any ignition
source including open flame and smoldering cigarettes.
4.15 If a docked Driver user interface displays the following in the Power Status
Window:
- Both External Batteries Missing
- and no AC Power Icon
- and there are External Batteries and/or AC power applied
remove the External Batteries and AC power. Reconnect AC Power and
reinsert the External Batteries.
4.16 Preliminary data on the use of the Companion 2 Driver versus the
Circulatory Support Console (CSS) with the TAH-t for patients who
received circulatory rescue intervention (
e.g. , extracorporeal membrane
oxygenation [ECMO] or intra-aortic balloon pump [IABP]) prior to implant
suggest a higher mortality for the Companion 2 Driver compared to the
CSS. A mortality difference was not observed among patients not initially
treated with a pre-implant circulatory intervention.
4.17 If upon docking the Driver into a Hospital Cart or Caddy, the Driver screen
flickers, flashes black and white, or turns off, immediately undock the
Driver and DO NOT attempt to dock the Driver again into the same
Hospital Cart or Caddy. A malfunction of the Hospital Cart or Caddy may
exist and it must be returned to SynCardia for evaluation. The Driver
should be docked into another Hospital Cart or Caddy.