Edwards HemoSphere

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HemoSphere Advanced Monitor 2 Safety and Symbols
2.2 Warnings
The following are warnings 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.
• Read this operator's manual carefully before attempting to use the Edwards HemoSphere advanced
monitor.
• Refer to the instructions for use provided with each compatible accessory before using it with the
HemoSphere advanced monitor.
• To prevent injury to patient or user, damage to platform, or inaccurate measurements, do not use
any damaged or non-compatible platform accessories, components or cables.
• Improper use of the HemoSphere advanced monitor could present a hazard to the patient.
Carefully read the “warnings” section of this manual, located in chapter 2, before using the
platform. (chapter 1)
• The HemoSphere advanced monitor is intended for use only in patient assessment. This instrument
must be used in conjunction with a bedside physiological monitor and/or patient clinical signs and
symptoms. If hemodynamic values obtained from the device are not consistent with the clinical
presentation of the patient, consider troubleshooting before initiating treatment options. (chapter 1)
• ECG signal input and all parameters derived from heart rate measurements have not been evaluated
for pediatric patients and are therefore not available for that patient population. (chapter 1)
• Shock hazard! Do not attempt to connect/disconnect system cables while hands are wet. Ensure
that hands are dry prior to disconnecting system cables. (chapter 3)
• Explosion Hazard! Do not use the HemoSphere advanced monitor in the presence of flammable
anesthetic mixture with air or with oxygen or nitrous oxide. (chapter 3)
• Make sure the HemoSphere advanced monitor is securely positioned or mounted and that all cords
and accessory cables are appropriately arranged to minimize the risk of injury to patients, users or
the equipment. (chapter 3)
• Do not stack additional equipment or items on top of the HemoSphere advanced monitor. (chapter
3)
• The HemoSphere advanced monitor must be positioned in an upright position to ensure IPX1
ingress protection. (chapter 3)
• Do not allow any liquids to splash onto the monitoring screen. Liquid buildup may disable the
touchscreen functionality. (chapter 3)
• Do not position the monitor so that it is difficult to access rear panel ports or power cord. (chapter
3)
• Equipment is rated for use with high-frequency surgical equipment. Inaccurate parameter
measurements can be caused by interference from high-frequency surgical equipment. To reduce
hazards that can arise from the use of high-frequency surgical equipment, only use undamaged
patient cables and accessories connected as specified in this operator’s manual. (chapter 3)
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14