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HemoSphere Advanced Monitor 2 Safety and Symbols
• This system is rated for use with defibrillators. To ensure proper defibrillator-proof operation, only
use undamaged patient cables and accessories connected as specified in this operators manual.
(chapter 3)
• All IEC/EN 60950 equipment, including printers, to be positioned no closer than 1.5 meters to the
patient’s bed. (chapter 3)
• Make sure the battery is fully inserted and the battery door is properly latched. Falling batteries
could seriously injure patients or clinicians. (chapter 3)
• Only use Edwards approved batteries with the HemoSphere advanced monitor. Do not charge the
battery pack outside of the monitor. Doing so can damage the battery or injure the user. (chapter 3)
• To prevent any interruptions to monitoring during power loss, it is recommended to use the
HemoSphere advanced monitor with the battery inserted. (chapter 3)
• In cases of power failure and battery depletion, the monitor will go through a controlled shut off
procedure. (chapter 3)
• Do not use the HemoSphere advanced monitoring platform without an installed power cord entry
cover. Failure to do so may result in fluid ingress. (chapter 3)
• Do not use extension cords or multiple socket devices to connect the power cord. Do not use
detachable power cords other than the power cord provided. (chapter 3)
• To avoid the risk of electric shock, the HemoSphere advanced monitor can only be connected to a
supply mains with grounding (protective earth). Do not use three prong to two prong power
adaptors. (chapter 3)
• Grounding reliability can only be achieved when the instrument is connected to a receptacle marked
“hospital only”, “hospital grade”, or its equivalent. (chapter 3)
• Disconnect the monitor from the AC source by unplugging mains power cable from the AC Mains.
The On/Off button on the monitor does not disconnect the system from the AC mains supply.
(chapter 3)
• Only use HemoSphere advanced monitor accessories, cables and or components that have been
supplied and labeled by Edwards. Using other unlabeled accessories, cables and or components may
affect patient safety and measurement accuracy. (chapter 3)
• Upon initiation of a new patient session, the default high/low physiological alarm ranges should be
checked to ensure that they are appropriate for the given patient. (chapter 6)
• Perform New Patient or clear the patient data profile whenever a new patient is connected to the
HemoSphere advanced monitor. Failure to do so may result in previous patient data in the historical
displays. (chapter 6)
• The analog communication ports of the HemoSphere advanced monitor share a common ground
that is isolated from the catheter interface electronics. When connecting multiple devices to the
HemoSphere advanced monitor, all devices should be provided with isolated power to avoid
compromising the electrical isolation of any of the connected devices. (chapter 6)
• Risk and Leakage current of the final system configuration must comply with IEC 60601-1:2005/
A1:2012. It is the responsibility of the user to ensure compliance. (chapter 6)
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14
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