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HemoSphere Advanced Monitor 2 Safety and Symbols
• Refer to the directions provided with each accessory for specific instructions on placement and use,
and for relevant WARNINGS, CAUTIONS, and specifications. (chapter 10)
• When the pressure cable is not in use, protect the exposed cable connector from fluid. Moisture
within the connector may result in the cable malfunctioning or in inaccurate pressure readings.
(chapter 10)
• Do not use the HemoSphere advanced monitoring platform as a pulse rate or blood pressure
monitor. (chapter 10)
• Do not wrap the main body of the oximetry cable in fabric or place directly on the patient's skin
for long periods of time (>10 min). The surface does get warm (up to 45 °C) and needs to dissipate
heat to maintain its internal temperature level. A software fault will trigger if the internal
temperature exceeds its limits. (chapter 11)
• Before touching Yes to recall oximetry data, confirm that the displayed data matches the current
patient. Recalling incorrect oximetry calibration data and patient demographics will result in
inaccurate measurements. (chapter 11)
• The Hypotension Probability Indicator feature, P(↓BP), should not be used exclusively to treat
patients. A review of the patient’s hemodynamics is recommended prior to initiating treatment.
(chapter 12)
• Only use approved HemoSphere advanced monitor accessories, cables and or components that
have been supplied and labeled by Edwards. Using unapproved accessories, cables and or
components may affect patient safety and measurement accuracy. (appendix B)
• The HemoSphere advanced monitor contains no user-serviceable parts. Removing the cover or any
other disassembly will expose you to hazardous voltages. (appendix F)
• Shock or fire hazard! Do not immerse the HemoSphere advanced monitor, modules, or platform
cables in any liquid solution. Do not allow any fluids to enter the instrument. (appendix F)
• Explosion Hazard! Do not open battery, dispose of in fire, store at high temperature or short
circuit. It may ignite, explode, leak or get hot, causing serious personal injury or death. (appendix F)
• Use of accessories, sensors, and cables other than those specified may result in increased
electromagnetic emissions or decreased electromagnetic immunity. (appendix G)
• No modification of the HemoSphere advanced monitor is allowed. (appendix G)
• Portable and mobile RF communication equipment can potentially affect all electronic medical
equipment, including the HemoSphere advanced monitor. Guidance on maintaining appropriate
separation between communications equipment and the HemoSphere advanced monitor is
provided in table G-3. (appendix G)
2.3 Cautions
The following are cautions that are used in the HemoSphere advanced monitor operator’s manual. They are
introduced in the manual where relevant to the function or procedure being described.
• Federal (USA) law restricts this device to sale by or on the order of a physician.
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14
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