The eli 380 is intended to be a high-performance, multichannel resting electrocardiograph.As a resting electrocardiograph, the eli 380 simultaneously acquires data from each lead.Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted.It is a device primarily intended for use in hospitals but may be used in medical clinics and offices of any size.· device is indicated for use to provide interpretation of the data for consideration by a physician.· device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.It is not intended as a sole means of diagnosis.· the interpretations of ecg offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.· device is indicated for use on adult and pediatric populations.· the device is not intended to be used as a vital signs physiological monitor.Remote troubleshooting into the reported issue, determined that the issue was likely due to a faulty radio card.The customer will order a replacement radio card to resolve the issue.Based on this information, no further actions are necessary at this time.If the eli 380 device loses connection to the wireless network, the device is unable to transmit or receive ecg¿s.This failed connection may result in a delay of patient treatment which may cause or contribute to a serious injury or death.Therefore, hillrom is reporting this connection failure as a product malfunction.
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