Vigileo Monitor Operator’s Manual Addendum –II April 2008

Update to Chapter 2, Section 2.2.2, Table 2-2 “Cautions” Table 2-2 Cautions Monitor Operation CAUTION Inaccurate cardiac output measurements can be caused by factors such as: • Improperly zeroed and/or leveled sensor/transducer • Over or under damped pressure lines • Excessive variations in blood pressure. Some examples that cause BP variations include, but are not limited to: * Post cardiopulmonary bypass surgery status * Intra-aortic balloon pumps • Any clinical situation where the arterial pressure is deemed inaccurate or not representative of aortic pressure; including but not limited to * Extreme peripheral vasoconstriction * Hyperdynamic conditions as seen in post liver transplant • Excessive patient movement • Electrocautery or electrosurgical unit interference (Chapter 3)

Update to Chapter 3, Section 3.5, Item 6 “Caution” CAUTION Inaccurate cardiac output measurements can be caused by factors such as: • Improperly zeroed and/or leveled sensor/transducer • Over or under damped pressure lines • Excessive variations in blood pressure. Some examples that cause BP variations include, but are not limited to: * Post cardiopulmonary bypass surgery status * Intra-aortic balloon pumps • Any clinical situation where the arterial pressure is deemed inaccurate or not representative of aortic pressure; including but not limited to * Extreme peripheral vasoconstriction * Hyperdynamic conditions as seen in post liver transplant • Excessive patient movement • Electrocautery or electrosurgical unit interference

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New feature: Norwegian Language Update to Chapter 4, Section 4.10, Figure 4-2 “Language Selection Screen” The Vigileo monitor now supports the Norwegian language:

Figure 4-2 Language Selection Screen

Update to Chapter 4, Section 4.10, Table 4-3 “Language Default Settings” Update to Chapter 8, Section 8.2.4, Table 8-3 “Language Default Settings” Addition of the Norwegian Language to the table: Table 4-3 Language Default Settings

Language Norsk

2

Height Units

Weight Units

International Units

Date Format

Time Format

cm

kg

Yes

DD.MM.YYYY

24 hour

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New feature: SV, SVI, SVV Display and Trending Overview SV, SVI, and SVV can now be displayed in the CO Frame or Oximetry Frame. They must be configured as secondary parameters as described below. When monitoring SV, SVI, and/or SVV, the Vigileo monitor continuously displays the secondary CO Frame and/or Oximetry Frame parameter. SV, SVI, and SVV are time-averaged values and are calculated at approximately 20-second intervals. SV is displayed in milliliters/beat (ml/b), SVI is displayed in milliliters/beat/body surface area (ml/b/m2), and SVV is displayed in percent (%). Selecting Secondary Parameters Use the CO Menu or the Oximetry Menu to configure a secondary parameter to the desired frame. The CO Menu is displayed when the CO Frame is selected and the Oximetry Menu is displayed when the Oximetry Frame is selected. Select the Parameter option. Selecting SV, SVI, or SVV will configure the secondary parameter and update the frame. The screen displayed in the Multipurpose Frame will also be updated to reflect the change in configuration. Limit alarms monitoring will be activated on the displayed parameter and inactivated on the removed parameter.

Figure 1 CO Menu

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NOTE

SV, SVI, and SVV are all CO Monitoring related parameters. Therefore, all of the conditions necessary to monitor CO/CI are also necessary to monitor SV, SVI, and SVV. The Patient Data and Zero Arterial Pressure can be selected on the CO Frame and performed while one of these secondary parameters is configured in order to start monitoring.

NOTE

If Oximetry has been calibrated and is being monitored, then it will continue monitoring in the background if SV, SVI, or SVV is being displayed in the Oximetry Frame.

SV, SVI, and SVV Trend Setup Menu Select Trend Setup to: • • • •

Set the Alarm limits Enable or disable audible alarms Set the vertical scales for use in Graphical Trends Set the Averaging Time (in the CO Frame only)

WARNING

Do not turn off the alarms in situations in which patient safety could be compromised.

Figure 2 SVV Trend Setup Screen 4

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Table 1 – SV, SVI, & SVV Trend Setup Options Option

Description

Selection Parameters

Return

Returns to the CO Menu.

None

Averaging Time

Sets the amount of time that CO/CI, 20 seconds SVR/SVRI, SV/SVI, and SVV are 5 minutes averaged. Select 20 seconds (default) to see rapid trending characteristics. Select 5 minutes to see smoother trend changes in values. Only available when accessed through the CO Frame.

Alarm (icon)

Toggle between Alarm Sounds Enabled and Alarm Sounds Disabled.

Scale Upper Limit

Scale Lower Limit

Set the scale for SV, SVI, or SVV on the Graphical Trend Screen

Alarm Upper Limit

Alarm Lower Limit

Set the alarm limits for SV, SVI, or SVV. An alarm will be triggered if the parameter goes outside of the set limits.

Enabled Alarm Icon Disabled Alarm Icon SV – 40 to 300 by 20 SVI – 40 to 200 by 20 SVV – 20 to 100 by 10 SV – 0 to 140 by 20 SVI – 0 to 140 by 20 SVV – 0 to 60 by 10 SV – 20 to 300 by 5 SVI – 20 to 200 by 5 SVV – 15 to 100 by 1 SV – 0 to 140 by 5 SVI – 0 to 100 by 5 SVV – 0 to 40 by 1

Update to Chapter 2, Section 2.4, Table 2-5 “Monitor Display Symbols” Addition of the SV/SVI Trend symbol and the SVV Trend symbol. Symbol

Description

Color

SV/SVI Trend Symbol

Peach

SVV Trend Symbol

Salmon

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Update to Chapter 4, Section 4.3, Table 4-1 “Accessories” Addition of the SVV parameter to the table: Monitored and Calculated Parameters Accessory

CO

Oximetry

SVR

SV

SVV

Edwards approved power cord

•

•

•

•

•

Edwards FloTrac Sensor

•

•

•

•

Optical Module

•

Analog Input Cable(s)

•

Update to Chapter 5, Section 5.5, CO Frame Additional Information: CO or CI is the CO Frame’s primary parameter. Alternately, the CO Frame can be configured to display a secondary parameter of SV, SVI, or SVV by going to the CO Menu.

Update to Chapter 5, Section 5.6, Oximetry Frame Additional Information: SvO2 or ScvO2 is the Oximetry Frame’s primary parameter. Alternately, the Oximetry Frame can be configured to display a secondary parameter of SV, SVI, or SVV by going to the Oximetry Menu.

Update to Chapter 5, Section 5.11.1, Limit Alarms

Addition to the description:

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NOTE

Limit alarms are active on the parameters currently being displayed in the CO Frame and the Oximetry Frame only.

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Update to Chapter 6, Section 6.2, CO Frame Additional Information: The CO Frame displays the most recently measured value for Cardiac Output or Cardiac Index (primary parameters). Alternately, the CO Frame can display the most recently measured value for Stroke Volume, Stroke Volume Index, or Stroke Volume Variation (secondary parameters). The frame includes the following: • • • •

Label field Trend symbol (“ Value field Alarm icon

” for CO or CI, “

” for SV or SVI, and “

” for SVV)

If the monitor is unable to calculate the current CO value, the CO, CI, SV, SVI, or SVV value is frozen at the last value and the time of the last value is shown.

Figure 6-2 Time-Stamped CO Frame

Update to Chapter 7, Section 7.2, Oximetry Frame Additional Information: The Oximetry Frame displays the most recently measured value for central or mixed venous oxygen saturation (primary parameters). Alternately, the Oximetry Frame can display the most recently measured value for Stroke Volume, Stroke Volume Index, or Stroke Volume Variation (secondary parameters). The frame includes the following: • • • • •

Label field Trend symbol (“ ” for ScvO2, “ Value field Alarm icon Signal quality index (SQI) bar

” for SvO2, “

” for SV or SVI, and “

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” for SVV)

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If an Oximetry parameter is being displayed and the monitor is unable to calculate the current oximetry value, the oximetry value is frozen at the last value and the time of the last value is shown. If the SV, SVI, or SVV parameter is being displayed and the monitor is unable to calculate the current CO value, the SV, SVI, or SVV value is frozen at the last value and the time of the last value is shown.

Figure 7-2 Time Stamped Oximetry Frame

Update to Chapter 10, Section 10.3, Graphical Trends Updates to the Graphical Trends section as follows: The Graphical Trend Screen contains a graph of the patient’s monitored parameters by time. The colors of the trend lines and the scales in the graph match the parameter colors of the parameters currently configured in the CO and Oximetry Parameter Frames. The Alarm Limits for the CO/CI and oximetry parameters are displayed as colored tick marks on the scales of the graph. If an alarm limit falls outside of the graph, a colored arrow is displayed at the top or bottom of the graph. The Graphical Trend Screen is initially displayed with the most recent data at the right. You can scroll forward and backward through time by using the Scroll Keypad Button. The time scale and vertical scales can be customized so you can zoom in or out to get a better picture of what occurred at any particular time.

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Update to Appendix C-1, Trend Scales Addition to Table C-1 as follows: Table C-1 Upper Trend Scale Limits Parameter

Upper Limit Range

Setting Increment

Default Value

Units

Oximetry

20 to 100

10

100

%

CO

4 to 20

1

12

l/min

CI

4 to 20

1

12

l/min/m2

SV

40 to 300

20

160

ml/beat

SVI

40 to 200

20

80

ml/beat/m2

SVV

20 to 100

10

50

%

Addition to Table C-2 as follows: Table C-2 Lower Trend Scale Limits Parameter

Lower Limit Range

Setting Increment

Default Value

Units

Oximetry

0 to 60

10

0

%

CO

0 to 10

1

0

l/min

CI

0 to 10

1

0

l/min/m2

SV

0 to 140

20

0

ml/beat

SVI

0 to 140

20

0

ml/beat/m2

SVV

0 to 60

10

0

%

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Update to Appendix C-2, Alarm Limits Addition to Table C-3 as follows: Table C-3 Upper Alarm Limits Parameter

Upper Limit Range

Setting Increment

Default Value

Units

Oximetry

20 to 99

1

99

%

CO

2 to 20

0.1

14

l/min

CI

1 to 20

0.1

7

l/min/m2

SV

20 to 300

5

120

ml/beat

SVI

20 to 200

5

60

ml/beat/m2

SVV

15 to 100

1

30

%

Addition to Table C-4 as follows: Table C-4 Lower Alarm Limits Parameter

Lower Limit Range

Setting Increment

Default Value

Units

Oximetry

0 to 60

1

10

%

CO

1 to 19

0.1

2

l/min

CI

0 to 19

0.1

1

l/min/m2

SV

0 to 140

5

20

ml/beat

SVI

0 to 100

5

10

ml/beat/m2

SVV

0 to 40

1

0

%

10

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New feature: SVV Filtering Exceeded Indicator When displaying SVV in the CO Frame or Oximetry Frame (see New Feature: SV, SVI, SVV Display and Trending in this addendum), the SVV Filtering Exceeded Indicator symbol “ “ will be displayed in the Frame when a high degree of pulse rate variability that could affect the SVV value is detected.

Update to Chapter 2, Section 2.4, Table 2-5 “Monitor Display Symbols” Addition of the SVV Filtering Exceeded Indicator symbol. Symbol

Description

Color

SVV Filtering Exceeded Indicator: High degree of pulse rate variability may be impacting SVV values.

Yellow

Update to Chapter 6, Section 6.2, CO Frame Additional Information If SVV is configured to the CO Frame, the SVV Filtering Exceeded Indicator symbol “ “ will be displayed in the Frame when a high degree of pulse rate variability that could affect the SVV value is detected. The FloTrac algorithm will typically filter a certain amount of pulse rate variability which may be a result of arrhythmias (i.e. up to 2 aberrant beats every 20 seconds); therefore, the symbol signifies that the amount of variability has exceeded the algorithm’s capacity for filtering.

Update to Chapter 7, Section 7.2, Oximetry Frame Additional Information If SVV is configured to the Oximetry Frame, the SVV Filtering Exceeded Indicator symbol “ “ will be displayed in the Frame when a high degree of pulse rate variability that could affect the SVV value is detected. The FloTrac algorithm will typically filter a certain amount of pulse rate variability which may be a result of arrhythmias (i.e. up to 2 aberrant beats every 20 seconds); therefore, the symbol signifies that the amount of variability has exceeded the algorithm’s capacity for filtering.

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Update to Chapter 10, Section 10.5, All Data Screen Addition of the description of the SVV Filtering Exceeded Indicator as follows: Each box in the All Data Screen will contain a parameter label with a value and the units of measure for the parameter. In addition, if the SVV parameter is displayed, its box will contain the SVV Filtering Exceeded Indicator symbol “ “ when a high degree of pulse rate variability that could affect the SVV value is detected. The FloTrac algorithm will typically filter a certain amount of pulse rate variability which may be a result of arrhythmias (i.e. up to 2 aberrant beats every 20 seconds); therefore, the symbol signifies that the amount of variability has exceeded the algorithm’s capacity for filtering. When the symbol is displayed, the value will be displayed in yellow.

Update to Chapter 10, Section 10.6, Tabular Trends Addition to the first paragraph of the Tabular Trends section as follows: Use Tabular Trends to review the patient’s past parameter values. The parameter values are shown in table format with the values for each parameter arranged by time. Up to five parameters are contained in the table. If the SVV parameter is displayed, each value box will contain the SVV Filtering Exceeded Indicator symbol “ “ when a high degree of pulse rate variability that could affect the SVV value is detected. The FloTrac algorithm will typically filter a certain amount of pulse rate variability which may be a result of arrhythmias (i.e. up to 2 aberrant beats every 20 seconds); therefore, the symbol signifies that the amount of variability has exceeded the algorithm’s capacity for filtering. When the symbol is displayed, the value will be displayed in yellow.

New feature: Edit Indicator in Derived Value Calculator Update to Chapter 6, Section 6.5, Derived Value Calculator Update to the third paragraph of the Derived Value Calculator description as follows: To enter or change an entry, highlight the name of the entry and then select the units and the amount. When a value is edited, its label will have an asterisk (*) appended. Derived values will automatically be displayed when their dependent values are available.

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New feature: Selectable Waveform Confirmation Period Update to Chapter 6, Section 6.6, Waveform Confirmation Changes to the Waveform Confirmation screen description as follows: Select the Waveform Confirmation option to display the arterial pressure waveforms in the Waveform Screen. The Waveform Confirmation screen allows the clinician to assess the quality of the arterial waveform and perform a frequency response test. The vertical axis is auto-scaled to the Average BP value ±50 mmHg. The horizontal axis can be set to a 5 second or 10 second period. To change the horizontal axis period, highlight the horizontal axis label and press the knob. The graph will start displaying using the new horizontal axis period. The Average Pulse Rate (PR) and Average Blood Pressure (BP) values are displayed above the waveform. The Average PR and Average BP numbers are updated every 20 seconds. If a value is out of range, the parameter value fields display “-----”.

New feature: Continuous Percent Change Fields Update to Chapter 10, Section 10.3, Graphical Trends Just above the graph are the Continuous % Change fields for the parameters being trended. The fields show the direction of the parameter value’s change (↑ increasing or ↓ decreasing), the time interval that the change encompasses (configurable from 5 to 30 minutes), and the amount of change in the parameter’s value as a percentage over the past time interval. CO/CI, SV/SVI, and SVV values are updated approximately every 20 seconds. Oximetry values are updated approximately every 2 seconds. Changing the time interval. 1. From the Graphical Trend Screen, rotate the knob until the Graphical Trend Screen is highlighted. 2. Press the knob. The Graphical Trend Setup Screen displays. 3. Rotate the knob until Continuous % Change Interval is highlighted and then press the knob. 4. A pop-up menu displays with the time scale choices. 5. Rotate the knob to highlight your choice for the new time interval and then press the knob. 6. To return to the Graphical Trend screen, rotate the knob, highlight Return and then press the knob.

NOTE

Changes to the Continuous % Change Interval in the Graphical Trend Screen will also change the interval in the Tabular Trend Screen.

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Figure 10-2 Graphical Trend Data Screen

Update to Chapter 10, Section 10.6, Tabular Trends Just above the table are the Continuous % Change fields for the parameters in the CO Frame and Oximetry Frame. The fields show the parameter label, direction of the parameter value’s change (↑ increasing or ↓ decreasing), the time interval that the change encompasses (configurable from 5 to 30 minutes), and the amount of change in the parameter’s value as a percentage over the past time interval. CO/CI, SV/SVI, and SVV values are updated approximately every 20 seconds. Oximetry values are updated approximately every 2 seconds.

Figure 10-9 Tabular Trend Data Screen 14

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You can change the time interval. 1. From the Tabular Trend Screen, rotate the knob until the Tabular Trend Screen is highlighted. 2. Press the knob. The Tabular Trend Setup Screen displays. 3. Rotate the knob until Continuous % Change Interval is highlighted and then press the knob. 4. A pop-up menu displays with the time scale choices. 5. Rotate the knob to highlight your choice for the new time interval and then press the knob. 6. To return to the Tabular Trend screen, rotate the knob, highlight Return and then press the knob.

NOTE

Changes to the Continuous % Change Interval in the Tabular Trend Screen will also change the interval in the Graphical Trend Screen.

Figure 10-11 Tabular Trend Menu

New feature: Percent Change Calculator The percent change calculator is a new screen that you can select from either the Graphical Trend Setup Menu or the Tabular Trend Setup Menu. Select the % Change Calculator option to compute the percent change in parameter values between a start time and an end time. The % Change Calculator provides a convenient way to display changes in parameter values over any time period.

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Figure 10-5A % Change Calculator Screen

The screen initially shows the changes in the patient’s parameter values between the Continuous % Change Interval prior to the current time and the current time. To enter a new time or date for the starting or ending time, highlight Time T1 or Time T2 and press the knob. Rotate the knob to move to a time or date field to change and press the knob. Rotate the knob to change the value and press the knob. When you rotate right out of the last field, the % Change Calculator will be updated based on the entered times. To exit the screen, select the Return option.

Update to Appendix B-1, Overview Addition to Table B-1 as follows: Table B-1 Cardiac Profile Equations Parameter

Description and Formula

Units

% Change

Percent Change in a Parameter between Time T1 and Time T2 % Change = (VT2 – VT1) / VT1 * 100

%

where: VT1 – 1 minute average of the value of the parameter at Time T1 VT2 – 1 minute average of the value of the parameter at Time T2

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New feature: Event Review – New Events Update to Chapter 10, Section 10.4, Event Review Update of the description of the Event Review Screen as follows: Use the Event Review Screen to view past events for the patient. Up to 128 events are recorded. Addition of three new events to Table 10-2 Event Types as follows:

Table 10-2 Event Types Event

Logging Time

BSA Change

When the BSA for the patient changes.

Averaging Time – 20

When the Averaging Time in the CO Trend Setup Menu is changed to 20 seconds.

Averaging Time – 5

When the Averaging Time in the CO Trend Setup Menu is changed to 5 minutes.

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

Edwards Lifesciences Services GmbH Edisonstr. 6 85716 Unterschleissheim, Germany Manufacturer Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686 USA Made in USA

2/09 P/N 197082002 A ©Copyright 2009, Edwards Lifesciences LLC All rights reserved.

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