Edwards Lifesciences

Vigilance II Operator’s Manual Addendum July 2008


9 Pages

Operator’s Manual Addendum  Vigilance II Monitor Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor This addendum contains the following: • Update to Patent Information in Preface • Modification to the general monitor description • Update to CAUTION – “Conduct periodic inspections …” • Update to CAUTION – “The accuracy of continuous …” • Addition of the WEEE symbol to the rear label • New Norwegian, Polish, Czech, Hungarian and Greek language support • New Patient Height & Weight Default values • New feature: Operational Pause Screen • New feature: Power Off Confirmation Screen • Change to Japanese Date format • Change to Japanese alarm handling • Event Review Log Expanded • “Service Required” message in Time/Date Frame • Correction – ICO (Bolus CO) Range Specification • Correction – CCO/CCI Alarm Setting Specification • Correction – CCO/CCO STAT and CCI/CCI STAT Red Line Setting Specification • Preventive Maintenance Update  Update to Preface Patents This product is manufactured and sold under one or more of the following US patent(s): US Patent No. 5,146,414; 5,305,760; 5,553,622; 5,634,470; 5,701,908; 5,755,670; 5,588,438; 5,687,733; 5,720,293; 6,045,512; 6,371,923; 6,387,052 and corresponding foreign patents. Additional patents pending. Modification to the general monitor description Update to Chapter 1, Section 1.1 - General The Vigilance II monitor measures cardiac output (CO) both continuously (CCO) and intermittently (ICO) using the bolus thermodilution method. The monitor may also be configured to measure continuous oxygen saturation (SvO2, ScvO2) as well as continuous end diastolic volume (EDV). When connected to an Edwards oximetry catheter, the monitor measures oximetry in adult and pediatric patients. The Vigilance II monitor also calculates hemodynamic and oxygenation parameters.  Edwards Lifesciences  1
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