Edwards Lifesciences

Vigileo Monitor Operator’s Manual Addendum May 2007


5 Pages

Operator’s Manual Addendum  Vigileo Monitor Cardiac Output/Oximetry Monitor Update to Chapter 1, Section 1.1 – Indications for Use The Vigileo monitor allows the clinician to continuously measure hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter the monitor measures oximetry in adults and pediatrics.  Update to Chapter 2, Table 2-4, Monitor Back Symbols and Connectors Change Figure Number 20 to add a symbol for Refurbished Unit. Figure Number 20  Symbol  Description  P/N  Part Number  REF  Model Designation Refurbished Unit (if applicable)  Update to: Chapter 4, Section 4.4.1 - Table 4-2 Environmental Specifications Appendix A, Table A-2 - Environmental Specifications The Operating temperature without Optical Module has been corrected to 0 to 45°C. Parameter Operating temperature without Optical Module Operating temperature with Optical Module Storage Temperature Relative Humidity, Operating and Storage Operating Atmospheric Pressure  Value 0 to 45 °C 10 to 37 °C -25 to 70 °C 10% to 95%, non-condensing 696 to 1013 hPa  Update to Chapter 4, Section 4.9.1, Starting the Monitor A description for the Power-On Clear Patient Data Screen as follows: Upon successful completion of the Power-On Self Tests, if any patient data exists that is less than 8 hours old, the Vigileo monitor asks if that patient’s data should be cleared (see Figure 4-2). If all patient data is more than eight hours old, the data is automatically deleted and the monitor displays the Power-On Patient Information Screen (See Figure 4-3). Edwards Lifesciences 1
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