Vigilance II Operator’s Manual Addendum July 2008

CAUTION – “Conduct periodic inspections…” Update to Chapter 2, Section 2.2.2 – Cautions – 2nd caution The "Conduct periodic inspections …" caution statement is being replaced to provide additional information:



CAUTION Inspect all cables (70CC2 patient cable, EKG slave cable, patient monitor interface cables, Optical Module) before each use. Pay particular attention to the cable jacket, strain relief and cable connectors. If the cable insulation is compromised or the cable is frayed, connector pins recessed or bent, or the connector itself is chipped or cracked, immediately discontinue use of the cable. Do not store cables tightly coiled.

CAUTION – “The accuracy of continuous …” Update to Chapter 2, Section 2.2.2 – Cautions – 12th caution Update to Chapter 12, Section 12.2.2.1 – Procedure (Analog Input Calibration Procedure) “The accuracy of continuous …” caution statement is being replaced to provide additional information:



CAUTION The accuracy of continuous SVR, SVRI, LVSWI, RVSWI, VO2, VO2I, DO2, DO2I, VQI, O2EI, CaO2, Ca-vO2, and O2ER depends upon the quality and accuracy of the MAP, CVP, and SaO2 data transmitted from the external monitors. Since MAP, CVP, and SaO2 analog signal quality from the external monitor cannot be validated by the Vigilance II monitor, actual values and the values (including all derived parameters) displayed by the Vigilance II monitor may not be consistent. The accuracy of continuous SVR, SVRI, LVSWI, RVSWI, VO2, VO2I, DO2, DO2I, VQI, O2EI, CaO2, Ca-vO2, and O2ER measurement, therefore, cannot be guaranteed. To aid in determining the quality of the analog signals, regularly compare the MAP, CVP, and SaO2 values displayed on the external monitor to the values displayed on the Vigilance II monitor. Refer to the external input device Operator's Manual for detailed information regarding accuracy, calibration, and other variables which may impact the analog output signal from the external monitor.

Addition of the WEEE symbol to the rear label Update to Chapter 2, Section 2.3 – Monitor Case Symbols The Vigilance II Monitor complies with the EC Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE). The WEEE symbol (Item 20) has been added to the rear of the monitor.

2

Edwards Lifesciences

Figure 2-2 Vigilance II Monitor Rear Panel Symbols

20

Separate collection for electrical and electronic equipment in accordance with EC Directive 2002/96/EC.

New Norwegian, Polish, Czech, Hungarian and Greek language support Update to Chapter 4, Section 4.8.2 – Startup Procedure and Chapter 6, Section 6.5, Table 6-2 Display Formation Option Descriptions and Appendix C, Section C3 The Vigilance II Monitor now supports the Norwegian, Polish, Czech, Hungarian and Greek languages. Please choose the appropriate language.

Edwards Lifesciences

3

Figure 4-5 Vigilance II Language Selection Display Screen

New Patient Height & Weight Default values Update to Chapter 6, Section 6.3.1 – Patient Data Entry – Height and Weight and Section 6.3.2 – Patient Data Entry -- BSA The default values for Height, Weight and BSA have been changed to more closely match average patient values.

4

English Default

International Default

Height

67 in.

170 cm

Weight

183 lbs.

83 kg

BSA

1.95 m2

1.95 m2

Edwards Lifesciences

New feature: Operational Pause Screen Overview: The Operational Pause Screen provides a quick and simple way for you to suspend CCO & Oximetry monitoring, with the attendant alarms, while the patient is on cardiopulmonary bypass. During cardiopulmonary bypass, CCO and Oximetry monitoring should not be performed since the blood flow is not sufficient to acquire accurate measurements. Consequently, alarms may sound as the catheter shifts within the patient interoperatively. These alarms are not relevant while the patient is on cardiopulmonary bypass. Initiating Operational Pause will stop CCO and Oximetry monitoring and will keep the alarms from disturbing the operating room personnel. Accessing Operational Pause: Press and hold the Alarm Silence keypad button for at least 3 seconds.

The Operational Pause Screen: Once the Alarm Silence button has been pressed and held for at least 3 seconds, the Operational Pause screen will be displayed in the Secondary Frame of the monitor (see Figure 1). While this screen is being displayed, CCO and Oximetry monitoring will be stopped. Therefore, all Large Parameter Frame values will be reduced in size and a time stamp will be placed below the value indicating the time that the last value was recorded.

Figure 1 - Operational Pause Screen

Returning to CCO Monitoring Mode: When the patient has been removed from cardiopulmonary bypass and you want to restart CCO and/or Oximetry monitoring, select Exit by pressing the navigation knob. If CCO was configured to a Large Parameter Frame prior to entering Operational Pause, you will be asked if you want to re-start CCO monitoring (see Figure 2).

Figure 2 - Operational Pause Screen – CCO Question Edwards Lifesciences

5

Select Yes if you are ready to begin CCO monitoring. Select No if you want to terminate Operational Pause but do not want to start CCO monitoring. Once you have made your selection, if Oximetry monitoring was being performed when Operational Pause was initiated, you will be asked if you want to re-calibrate Oximetry (see Figure 3). Hemoglobin may have changed interoperatively.

Figure 3 - Operational Pause Screen – Oximetry Question Selecting Yes will take you directly to the Oximetry Frame Menu, allowing you to proceed with calibration. Selecting No will re-start Oximetry monitoring and return you to the general CCO monitoring display that was active when Operational Pause was initiated.

Returning to ICO Monitoring Mode: When the patient has been removed from cardiopulmonary bypass and you want to begin ICO and/or Oximetry monitoring of the patient again, select Exit by pressing the navigation knob. If Oximetry monitoring was being performed when Operational Pause was initiated, you will be asked if you want to re-calibrate Oximetry (see Figure 4). Hemoglobin may have changed interoperatively.

Figure 4 - Operational Pause Screen – Oximetry Question Selecting Yes will take you directly to the Oximetry Frame Menu, allowing you to proceed with calibration. Selecting No will re-start Oximetry monitoring and return you to the general ICO monitoring display that was active when Operational Pause was initiated.

6

Edwards Lifesciences

New feature: Power Off Confirmation Screen Update to Chapter 5, Section 5.15.1 – ON/OFF (Keypad Function) The ON/OFF push button is pressed to change the status from Power ON to Power STANDBY. In order to prevent accidentally powering off the monitor by pressing the wrong keypad button, a Power Off Confirmation Screen is displayed in the Secondary Frame when the ON/OFF button is pressed (see Figure 5-14).

Figure 5-14 - Power Off Confirmation Screen Selecting Yes will power the monitor off. Selecting No will return you to your last monitoring screen.

Change to Japanese Date format Update to Appendix C, Section C3 – Display Settings The default setting for the Date Format is “MM/DD/YYYY” for English and Japanese and “DD.MM.YYYY” for all other languages. Change to Japanese alarm handling Update to Chapter 5, Section 5.5.1.2 – Disabling/Enabling the Alarm



Note Vigilance II monitors that are not configured to English (U.S.) or Japanese will sound an audible tone for 3 seconds every 3 minutes when an alarm is disabled in one or all of the Large Parameter Frames.

Event Review Log Expanded Update to Chapter 11, Section 11.3.3 – Add an Event to the Trend Graph The monitor can now store up to 64 operator-selected and automatically recorded events (clinical interventions) (increased from 32).

Edwards Lifesciences

7

“Service Required” message in the Time/Date Frame When the monitor’s clock battery power becomes low, the message “Service Required” will alternate with the current date and time in the Time/Date Frame. The monitor must be returned to an authorized Edwards service center for battery replacement. The clock battery is expected to have approximately a 10 year life. When the clock battery no longer has power, the monitor will shut down with an error screen.

Correction – ICO (Bolus CO) Range Specification Update to Appendix A, Section A2 – Measurement Specifications – Table A-2 Base Parameters The ICO Measurement Specification should be:

Parameter

Specification

ICO

Range

0 to 20 l/min

Interrmittent (Bolus) Cardiac Output

Reproducibility1

±3% or 0.1 l/min, whichever is greater

Notes: 1. Coefficient of variation – measured using electronically generated data.

Correction – CCO/CCI Alarm Setting Specification Update to Appendix C, Section C2.1 – Alarms Upper Limit Specification Update to Appendix C, Section C2.2 – Alarms Lower Limit Specification The CCO & CCI Alarms Upper Limit Specification should be:

Upper Limit Range

Setting Increment

Default Value

Units

CCO

2.0 to 20.0

0.1

14.0

l/min

CCI

1.0 to 20.0

0.1

7.0

l/min/m2

Lower Limit Range

Setting Increment

Default Value

Units

CCO

1.0 to 19.0

0.1

2.0

l/min

CCI

0.0 to 19.0

0.1

1.0

l/min/m2

Parameter

The CCO & CCI Alarms Lower Limit Specification should be:

Parameter

8

Edwards Lifesciences

Correction – CCO/CCO STAT and CCI/CCI STAT Red Line Setting Specification Update to Appendix C, Section C6.2.3 –Upper Red Line Value Limits Specification Update to Appendix C, Section C6.2.4 –Lower Red Line Value Limits Specification The CCO/CCO STAT & CCI/CCI STAT Upper Red Line Value Limits Specification should be:

Parameter

Upper Limit Range

Setting Increment

Default Value

Units

CCO/CCO STAT

2.0 to 20.0

0.1

14.0

l/min

CCI/CCI STAT

1.0 to 20.0

0.1

7.0

l/min/m2

The CCO/CCO STAT & CCI/CCI STAT Lower Red Line Value Limits Specification should be:

Parameter

Lower Limit Range

Setting Increment

Default Value

Units

CCO/CCO STAT

1.0 to 19.0

0.1

2.0

l/min

CCI/CCI STAT

0.0 to 19.0

0.1

1.0

l/min/m2

Preventive Maintenance Addition to Appendix F, Section F7 Inspect all cables (70CC2 patient cable, EKG slave cable, patient monitor interface cables, Optical Module) before each use. Pay particular attention to the cable jacket, strain relief and cable connectors. If the cable insulation is compromised or the cable is frayed, connector pins recessed or bent, or the connector itself is chipped or cracked, immediately discontinue use of the cable. Do not store cables tightly coiled.

Edwards Lifesciences, the stylized E logo and Vigilance II are trademarks of Edwards Lifesciences Corporation; Edwards Lifesciences and the stylized E logo are registered in the U.S. Patent and Trademark Office.

Edwards Lifesciences Services GmbH Edisonstr. 6 85716 Unterschleissheim, Germany 7/08 P/N 195780004 A ©Copyright 2008, Edwards Lifesciences LLC All rights reserved.

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686 USA Made in USA

Edwards Lifesciences

9