HemoSphere Advanced Monitoring Platform Setup guide

Parameter tile

Navigation bar Main windowPowerbutton

Status bar Visual alarm indicator

Information bar

HemoSphere advanced monitor screen features

Monitoring mode

Start/stop monitoring

Time-in-Target software

Zero and Waveform

Intervention analysis

Continuous blood pressure waveform, available on the following screens:• Graphical trend screen• Main monitoring screen

The settings icon provides access to: • Clinical tools • Settings• Select screens • Help

Silence audible alarm/pause mode

Information bar (located at the top of the screen)

Swan-Ganz mode only

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Acumen IQ mode only

Clinical actions

Changing parameters1. Touch the displayed parameter label located

inside the parameter tile to change it to a different parameter.

2. The tile configuration menu will show the selected parameter highlighted and other parameters currently being displayed outlined. Available parameters appear on the screen without highlight.

3. Select desired parameter to display.

Changing targets and alarms1. Touch the parameter value on a

parameter tile.2. Adjust target values using arrows or select

value and type in parameter target. 3. Select Target to disable or enable colors

in target ranges.4. To silence parameter alarms, select

Audible Alarm button.

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oSphere clinical actions

Pause monitoring1. Hold the Silence Alarm button until monitoring

pause confirmation pop-up appears.2. Confirm suspension of monitoring operations.3. To resume monitoring, touch the Monitoring

Pause Exit button.

ZeroingZero with the stopcock off to the patient and open to air:1. Hold down zero button on the pressure

cable to pull up zero screen.2. Hold down zero button until a tone is

heard to complete zeroing. or Zeroing can be completed by selecting the Quick Zero button to pull up the zero screen, then select Zero.

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1. Turn on monitor and connect the HemoSphere pressure cable to the HemoSphere monitoring platform.

2. Select language if prompted, then enter patient demographics.

3. Select minimally-invasive technologythen select Start Monitoring.

4. Open the Acumen IQ sensor packaging and inspect contents. Replace all caps with non-vented caps and ensure that all connections are tight.

5. With gravity only (no pressure in pressure bag), flush the Acumen IQ sensor holding pressure tubingin upright position as the columnof fluid raises through the tubing,pushing air out of the pressure tubing until the fluid reaches the end ofthe tubing.

6. Ensure air has been removed from the IV bag. To prime the IV bag and the Acumen IQ sensor: Insert IV bag into the pressure bag and hang on IV pole (do not inflate).

7. Mount the Acumen IQ sensor on an IV pole using the appropriate holder.

Acumen IQ Sensor Setup guide

Acum

en IQ sensor

7. Plug green connector from Acumen IQ sensor to HemoSphere pressure cable.

8. Plug red connector from Acumen IQsensor to bedside cable.

9. Level the Acumen IQ sensor to thephlebostatic axis. Note: It is important to keep the Acumen IQ sensor stopcock level to the phlebostatic axis at all times to ensure accuracy of cardiac output.

10. To zero, turn stopcock off to the patient and open to air: 1. Hold down zero button on the

pressure cable to pull up zero screen.2. Hold down zero button until a tone is

heard to complete zeroing. or Zeroing can also be completed by selecting the Quick Zero button to pull up thezero screen, then select Zero.

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HemoSphere advanced monitor setup

1. Slide the HemoSphere tissue oximetrymodule into the monitor.

2. Connect the ForeSight Elite tissue oximetry module cable into theHemoSphere tissue oximetrymodule (Figure 1). Note: ForeSight Elite module LED illuminates green when connected to port A, and blue when connected to port B.

3. Select Continue Same Patient or New Patient, enter patient data.Select corresponding patient mode. Note: Tissue oximetry works with both invasive and minimally-invasive modes.

4. Ensure StO2 parameter tiles are displayed for tissue oximetry.

ForeSight Elite sensor setup

1. Open ForeSight Elite sensor packagingand inspect for damage (Figure 2).

2. Clean patient’s skin and ensure area is dry prior to sensor application.

3. Remove protective liner andapply sensors.

4. Apply pressure around the edges of thesensor to ensure adequate adhesion.

5. Connect sensors to ForeSight Elite tissue oximetry module cable. Ensure each sensor is connected with a tactile click (Figure 3).

ForeSight Elite Tissue Oximetry System Setup guide

Figure 1

Figure 2

Figure 3

ForeSight Elite

Sensor location setup

1. Touch the patient figure (Figure 4) to access Sensor Location tab.

2. Ensure correct body location is selectedwith corresponding sensor channel inSensor Location tab (Figure 4).

3. Sensor channel appears in the upper left ofthe parameter tile (Figure 4). Select channel. Then select the appropriate StO2 channel from tile configuration menu (Figure 5).

4. Select the patient monitoring mode: adult or pediatric.

Figure 4

A B

Figure 5

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Parameter tile area (Figure 6)

1. StO2 reading displays current StO2% level (a).2. Sensor Location displays location and side

of body sensor is placed (b).3. Channel Location displays which

channel each sensor is connected (c).4. Parameter displays which parameter

is being monitored (d).5. Reference Value displays the reference

value from timepoint which menuselection is made (e).

6. Signal Quality Indicator displays the quality of the signal (f).

Display reference value

1. Select parameter tile, then select Intervals/Averaging tab (Figure 7).

2. Select Change Interval tab and select Reference.

3. Select % Changed or Value Difference in Change Display button.

Figure 7

Figure 6

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Skin check assessment

1. Select parameter tile, then selectSensor Location tab.

2. Select Skin Check Reminder button to choose a time interval between skin check notifications.

3. When performing skin checkassessment lift the sensor to assess the skin integrity under the sensor. Move sensor if circulatory condition or skin integrity has deteriorated.

1. Turn on monitor and connect the HemoSphere pressure cable to the HemoSphere monitoring platform.

2. Select language if prompted, then enter patient demographics.

3. Select minimally-invasive technologythen select Start Monitoring.

4. Open the FloTrac sensor packaging and inspect contents. Replace all capswith non-vented caps and ensurethat all connections are tight.

5. With gravity only (no pressure inpressure bag), flush the FloTrac sensor holding pressure tubing in uprightposition as the column of fluid raises through the tubing, pushing air outof the pressure tubing until the fluid reaches the end of the tubing.

6. Ensure air has been removed from the IV bag. To prime the IV bag and the FloTrac sensor: Insert IV bag into the pressure bag and hang on IV pole (do not inflate).

7. Mount the FloTrac sensor on an IV pole using the appropriate holder.

FloTrac Sensor Setup guide

FloTrac sensor

7. Plug green connector from FloTrac sensor to HemoSphere pressure cable.

8. Plug red connector from FloTrac sensorto bedside cable.

9. Level the the FloTrac sensor to thephlebostatic axis. Note: It is important to keep the the FloTrac sensor stopcock level to the phlebostatic axis at all times to en sure accuracy of cardiac output.

10. To zero, turn stopcock off to the patient and open to air: 1. Hold down zero button on the

pressure cable to pull up zero screen.2. Hold down zero button until a tone is

heard to complete zeroing. or Zeroing can also be completed by selecting the Quick Zero button to pull up thezero screen, then select Zero.

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Swan-Ganz Module Setup guide

1. Ensure the HemoSphere Swan-Ganz module is inserted into the monitor. The module will click when properlyengaged.

2. Connect the patient CCO cable to the HemoSphere Swan-Ganz module.

3. Attach the thermistor and thermal filament catheter connections to the patient CCO cable by aligning arrows.

4. Touch the Start monitoring icon.

A countdown timer will appear indicating CO data is being collected.

After approximately 5 to 12 minutes, when sufficient data has been obtained,a CO value will appear.

For longer time spans betweencalculations, select STAT CO (sCO)as a key parameter. Estimate of theCO value updated every 60 seconds.

Swan-G

anz module

Oximetry (SvO2 / ScvO2) connection overviewNote: Swan-Ganz catheter should not be primed prior to In Vitro calibration.

1. Connect the HemoSphere oximetry cable to the HemoSphere advanced monitor.

2. Connect the HemoSphere oximetry cable to the oximetry portof the Swan-Ganz catheter.

3. Select Settings on navigation bar.

4. Select Oximetry Calibration.

5. Select In Vitro Calibration or In Vivo Calibration as desired and follow prompts.

Pause monitoring1. Hold the Silence Alarm button until monitoring pause

confirmation pop-up appears.

2. Confirm suspension of monitoring operations.

3. To resume monitoring, touch the Monitoring Pause Exit button.

EDV/RVEF monitoring Right ventricular end diastolic volume (EDV) monitoring is available in conjunction with CO monitoring mode when using a Swan-Ganz CCOmbo V catheter and ECG signal input.

1. Ensure patient CCO cable is connected to Swan-Ganz catheter.

2. Connect the ECG interface cable’s 1/4 inch miniature phone plug to the ECG monitor input on the rear panel of the HemoSphere advanced monitor.

3. Change parameter tiles to reflect EDV/RVEF parameters as desired.

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In Vitro Calibration Note: Swan-Ganz catheter should not be primed prior to In Vitro calibration.

1. Touch the Settings icon and select Oximetry Calibration.

2. At the top of the Oximetry Calibration screen, select OximetryType: SvO2 or ScvO2.

3. Touch In Vitro Calibration icon. On the In Vitro calibration screen, enter either the patient’s hemoglobin(HGB) or hematocrit (Hct).

4. Touch Calibrate button to start thecalibration process.

5. When the calibration successfully completes, the following message appears: In Vitro Calibration OK, insert catheter.

6. Insert the catheter as described in the catheter instructions for use.

Oximetry (SvO2/ScvO2) Calibration Setup guide

Oxim

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For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

Edwards devices placed on the European market meet the requirements for bearing the CE marking of conformity.

ForeSight Elite tissue oximetry system is manufactured by CAS Medical, Inc., a subsidiary of Edwards Lifesciences Corporation.

Edwards, Edwards Lifesciences, the stylized E logo, Acumen, Acumen IQ, CCOmbo V, FloTrac, ForeSight, ForeSight Elite, HemoSphere, Swan, Swan-Ganz, and Time-in-Target are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

© 2019 Edwards Lifesciences Corporation. All rights reserved. E10545/12-19/CC.

Edwards Lifesciences • Route de l'Etraz 70, Nyon 1260 Switzerland • edwards com

edwards.com

In Vivo Calibration 1. Touch the Settings icon and select

Oximetry Calibration.

2. At the top of the Oximetry Calibration screen,select Oximetry Type: SvO2 or ScvO2.

3. Touch In Vivo Calibration button.Touch Continue button to proceed tothe draw operation.

4. When baseline calibration is successful,touch Draw button and perform blood draw.

5. Draw the blood sample slowly (2 mL or 2 cc over 30 seconds) and send the blood sample to the lab for measured analysis by co-oximeter.

6. When lab values are received, touch HGB button to enter the patient’s hemoglobin or Hct button to enter the patient’s hematocrit.Enter the lab oximetry value (SvO2 or ScvO2).

7. Touch Calibrate button to complete.

Note: This process requires approved personnel to draw waste blood (clearing volume) and a blood sample for laboratory processing.

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