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The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be a defective temperature cable.However, this could not be confirmed.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿patient therapy selection use the patient therapy selection screen to initiate a new patient, continue a current patient, or access the advanced setup screen.New patient - normothermia select normothermia if the therapy goal is to maintain a patient temperature at a pre-defined target temperature for an indefinite period of time.Press the normothermia button to display the normothermia therapy screen.New patient - hypothermia select hypothermia to reduce and maintain a patient temperature at a set target temperature for a defined period of time, then slowly re-warm the patient at a controlled re-warming rate.Press the hypothermia button to display the hypothermia therapy screen.Additional protocol option two additional protocols (hypothermia or normothermia) may be visible on the patient therapy selection screen.Current patient the continue current patient button and the date and time that the current therapy was paused will display on the patient therapy selection screen if a patient therapy was paused within the past 6 hours.Press the continue current patient button to resume a paused patient therapy.Initiate normothermia (control patient & rewarm patient) normothermia therapy is initiated and managed, and patient temperature is automatically controlled to a set target temperature from the control patient window in the normothermia therapy screen.The control patient window displays the patient target temperature and the duration since the initiation of normothermia therapy.To initiate normothermia therapy: 1) from the patient therapy selection screen, press the normothermia button to display the normothermia therapy screen.2) the default patient target temperature will display in the control patient window.3) to modify the patient target temperature, press the adjust button to display the control patient-adjust window.4) control patient to: use the up and down arrows to set the desired patient target temperature to control the patient.5) rewarm at a rate of: use the up and down arrows on the right of the screen to set the rewarming rate.6) press the save button to save the new settings and close the control patient-adjust window 7) press start, in the control patient window to initiate therapy.You will hear a tone and then a voice stating ¿therapy started¿.Additionally, the control patient window and the arctic sun® temperature management system icon will blink, indicating that therapy is in progress.Initiate hypothermia (cool patient and rewarm patient) hypothermia therapy is initiated and managed, and patient temperature is automatically controlled to a set target temperature from the cool patient and rewarm patient windows in the hypothermia therapy screen.The cool patient window displays the cooling phase patient target temperature and the length of time remaining in the cooling phase of the hypothermia therapy.The rewarm patient window displays the rewarming phase patient target temperature and the length of time remaining in the rewarming phase of the hypothermia therapy.To initiate hypothermia therapy: from the patient therapy selection screen, press the hypothermia button to display the hypothermia therapy screen.1.Cool patient settings ¿ the default patient target temperature and duration will display in the cool patient window.¿ ¿ to modify the patient target temperature and duration, press the adjust button to display the cool patient-adjust window.¿ cool patient to: use the up and down arrows on the left side to set the desired patient target temperature to cool the patient ¿ cool patient for: use the up and down arrows on the right side to set the cooling duration to cool the patient before rewarming begins.¿ press the save button to save the new settings and close the cool patient-adjust window 2.Rewarm patient settings ¿ the default patient target temperature and duration will display in the rewarm patient window.¿ to change the rewarming phase patient target temperature and rewarming rate, press the adjust button in the rewarm patient window to display the rewarm patient-adjust screen.Use the up and down arrows on the left side to set the desired final patient target temperature.¿ rewarm patient to: use the up and down arrows on the right side to set the desired final patient target temperature.¿ rewarm at a rate of: use the up and down arrows in the center of the screen to set the rewarming rate.¿ rewarm patient from: when cooling a patient, adjustment of the rewarm patient from setting on the left side of the screen is disabled and defaults to the cool patient target temperature.¿ when rewarming a patient, the rewarm patient from adjustment is enabled and the value can be modified.The rewarm patient from setting is the temperature to which the system is currently controlling the patient.The rewarm patient from temperature will automatically increase as the rewarming process continues.This feature allows the rewarming procedure to be optimized by allowing complete control of the rewarming ramp.¿ using the rewarm patient from temperature, the rewarm patient to temperature and the rewarming rate settings, the system will calculate and display the rewarming duration and the date/time at which the patient will reach the final rewarming target temperature.¿ press the save button to save the new settings and close the rewarm patient-adjust window.3.Initiate patient cooling ¿ press start, in the cool patient window to initiate therapy.You will hear a tone and then a voice stating ¿therapy started¿.Additionally, the cool patient window and the arctic sun® temperature management system icon will blink, indicating that therapy is in progress.4.Initiate patient rewarming ¿ upon completion of the cooling phase, there are two options for initiation of patient rewarming, either automatically or manually, depending on the rewarming begins setting in hypothermia settings.¿ if rewarming begins is set to automatically, the rewarming process starts automatically when the cool patient therapy is complete and the duration reaches zero.¿ if rewarming begins is set to manually, the rewarming process starts when the start button is pressed in the rewarm patient window.The cooling process will continue until the rewarm patient start button is pressed.An alert will occur when the cool patient duration reaches zero.When the rewarm patient duration timer reaches zero, the system will continue to control the patient to the target temperature until the stop button is pressed.Once in normothermia, the timer will reset and begin tracking the duration of normothermia therapy.End therapy ¿ from the normothermia therapy or hypothermia therapy screen, press the stop button to terminate water circulation to the pads.¿ press the empty pads button, and follow the instructions to purge the pads of water.¿ disconnect the pads from the fluid delivery line.¿ slowly and carefully remove pads from the patient skin.¿ discard the used pads in accordance with hospital procedures for medical waste.¿ press the power switch off.If power is lost while the power switch is in the on position, an audible alert will be issued until it is switched off.This alerts the user that the treatment may have been accidentally stopped." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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