noninvasive advanced hemodynamic monitoring · 2020-03-11 · see chapter 14, "ev1000 clinical...

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Noninvasive advanced hemodynamic monitoring Smart. Innovation. ClearSight system

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Page 1: Noninvasive advanced hemodynamic monitoring · 2020-03-11 · See Chapter 14, "EV1000 Clinical Platform NI AdvancedFeatures" , for more infor-mation. Physio Relationship The Physio

Noninvasive advanced hemodynamic monitoringSmart. Innovation.

ClearSight system

Page 2: Noninvasive advanced hemodynamic monitoring · 2020-03-11 · See Chapter 14, "EV1000 Clinical Platform NI AdvancedFeatures" , for more infor-mation. Physio Relationship The Physio

Navigating the EV1000 Clinical Platform NI 5-4

If there are 4 Key Parameters being displayed when theART display button is touched, display of the 4th key parameter is temporarily removed and the ART graph is placed at the top of the remaining 3 Key Parameter trend graphs.

Intervention EventsWhile in the Graphical Trend screen, selecting the Intervention button provides a menu of Inter-vention types, details and a notes section.

To enter a new Intervention:

1 Select the Intervention Type from the New Interventionmenu on left.

2 Select Detail from right menu tab. Unspecified is set as a default.

3 Select the Keyboard icon to enter notes (optional).

4 Touch the Enter button.

To enter a previously used Intervention:

1 Select the Intervention from the Recents list tab.

2 To add, edit or remove a note, touch theKeyboard icon.

3 Touch the Enter button.

Table 5-1 Intervention Events

After selection of the intervention type, markers indicatingthe intervention are visually displayed on all graphs except the real-time ART display. These markers can be selected for more information. Upon touching the marker, an informationballoon will appear. See Figure 5-6: Graphical Trend Screen - Intervention information balloon. The information balloondisplays the specific intervention, date, time and notes pertaining to the intervention. Touching the edit button allowsthe user to edit intervention time, date, and note. Touching theexit button closes the balloon.

The Information balloon has a 2 minute time out.

Intervention Editing. The time, date, and associated note for each intervention can be edited after initial entry:

1 Touch the Intervention Event Indicatorassociated with the intervention to be edited.

Figure 5-4 Graphical Trend Screen - Arterial Waveform Display

Figure 5-5 Graphical Trend- Intervention

Intervention Indicator TypeIntervention

(green)

Inotrope Vasodilator

VasopressorPEEP

Positional

(purple)

Passive Leg RaiseTrendelenburg

Fluids

(blue)

Red Blood CellsColloid

Crystalloid

Custom

(grey)

Custom Event

5-7 Navigating the EV1000 Clinical Platform NI

Cockpit ScreenThis monitoring screen, shown in Figure 5-11, displaysglobes with the values of the parameter being monitored.They graphically indicate target, out of range and target values with needle indicators to show where the patient’s parameter falls. In addition, the value within the globe willflash when the parameter is alarming.

The Key Parameters display a more complex target and alarm indicator. The full display range of the parameter is used tocreate a gauge from the graphical trends minimum to maximum settings. A needle is used to indicate the current value on the circular gauge scale. When target ranges are enabled, red, yellow and green are used to indicate the target and alarm regions within the circular gauge. When targetranges are not enabled, the circular gauge area is all gray incolor and target or alarm indicators are removed. The value indicator arrow changes to indicate when the values are out of the gauge scale limits.

Goal Positioning ScreenThe Goal Positioning Screen allows the user to monitor andtrack the relationship of two key parameters by plotting themagainst each other on an XY plane. See Chapter 14, "EV1000 Clinical Platform NI Advanced Features" , for more infor-mation.

Physio RelationshipThe Physio Relationship screen, as shown in Figure 5-12,displays most of the parameters available on the system andtheir relationship to each other. The screen displays lines connecting the parameters highlighting the relationship of the parameters to each other.

Line colors correspond to the lanterns to draw your eye to problem areas. If a lantern turns yellow and the one above is green, the vertical line above and the horizontal line belowturn yellow. See Chapter 8 “Physiology and PhysioRelationship Monitoring Screens” for more information.

Status IndicatorsThe lantern at the top of each parameter globe indicates thepatient’s current status. The color changes as the patient’s status changes. The globes may display additional infor-mation:

Figure 5-11 Cockpit Monitoring Screen

Figure 5-12 Physio Relationship Screen

Figure 5-13 Parameter Globe

SVV Filtering Exceeded Indicator

Audible alarm indicator

Continuous % ChangeIndicator

Target StatusIndicator

Parameter Value

Units

Parameter Name

Visual clinical decision support screens allow for beat-to-beat recognition of rapidly changing clinical situations.

Continuous access to your choice of parameters on the EV1000 clinical platform, when used with the noninvasive ClearSight system, enables you to maintain your patients in the optimal volume range.

EV1000 clinical platform Color-based indicators communicate patient status at a glance, and visual clinical support screens allow for immediate recognition and increased understanding of rapidly changing clinical situations to help you make better decisions.

Easy-to-use touch screens allow selection of the parameters most meaningful for each clinical situation.

Advanced hemodynamic parameters help guide you to individualized fluid management in the OR and ICU.

Heart Reference Sensor The ClearSight system Heart Reference Sensor (HRS) compensates for hydrostatic pressure changes due to height differences between finger and heart. The HRS compensates for clinician repositioning of the patient’s hand during a procedure or for patient movement.

Page 3: Noninvasive advanced hemodynamic monitoring · 2020-03-11 · See Chapter 14, "EV1000 Clinical Platform NI AdvancedFeatures" , for more infor-mation. Physio Relationship The Physio

The ClearSight system is a noninvasive solution that offers you proactive decision support to help optimize perfusion.

Continuous data offered by the validated ClearSight system enables you to proactively optimize perfusion through hemodynamic management.

A versatile approach to continuous monitoring Upon starting a measurement, the finger cuff can be used and re-applied for up to 72 hours on one patient. To increase comfort, two ClearSight finger cuffs may be connected simultaneously to alternate the measurement between two fingers. This allows uninterrupted continuous monitoring.

The ClearSight system provides advanced hemodynamic parameters and continuous noninvasive blood pressure from a noninvasive finger cuff.

Extends hemodynamic monitoring The ClearSight system gives you noninvasive access to automatically calculated, beat-to-beat hemodynamic information for a broad patient population, including patients in whom an arterial line would not typically be placed.1

Noninvasive hemodynamic monitoring offered by the ClearSight system provides information to enable you to make proactive clinical decisions across the continuum of care, including moderate- to high-risk surgery patients, and can be utilized to manage patients’ changing clinical situations in surgical, as well as acute care settings.

Advanced hemodynamic parameters • Cardiac Output (CO)• Stroke Volume (SV)• Stroke Volume Variation (SVV)

• Systemic Vascular Resistance (SVR)

• Mean Arterial Pressure (MAP)

Page 4: Noninvasive advanced hemodynamic monitoring · 2020-03-11 · See Chapter 14, "EV1000 Clinical Platform NI AdvancedFeatures" , for more infor-mation. Physio Relationship The Physio

5-7 Navigating the EV1000 Clinical Platform NI

Cockpit ScreenThis monitoring screen, shown in Figure 5-11, displaysglobes with the values of the parameter being monitored.They graphically indicate target, out of range and target values with needle indicators to show where the patient’s parameter falls. In addition, the value within the globe willflash when the parameter is alarming.

The Key Parameters display a more complex target and alarm indicator. The full display range of the parameter is used tocreate a gauge from the graphical trends minimum to maximum settings. A needle is used to indicate the current value on the circular gauge scale. When target ranges are enabled, red, yellow and green are used to indicate the target and alarm regions within the circular gauge. When targetranges are not enabled, the circular gauge area is all gray incolor and target or alarm indicators are removed. The value indicator arrow changes to indicate when the values are out of the gauge scale limits.

Goal Positioning ScreenThe Goal Positioning Screen allows the user to monitor andtrack the relationship of two key parameters by plotting themagainst each other on an XY plane. See Chapter 14, "EV1000 Clinical Platform NI Advanced Features" , for more infor-mation.

Physio RelationshipThe Physio Relationship screen, as shown in Figure 5-12,displays most of the parameters available on the system andtheir relationship to each other. The screen displays lines connecting the parameters highlighting the relationship of the parameters to each other.

Line colors correspond to the lanterns to draw your eye to problem areas. If a lantern turns yellow and the one above is green, the vertical line above and the horizontal line belowturn yellow. See Chapter 8 “Physiology and PhysioRelationship Monitoring Screens” for more information.

Status IndicatorsThe lantern at the top of each parameter globe indicates thepatient’s current status. The color changes as the patient’s status changes. The globes may display additional infor-mation:

Figure 5-11 Cockpit Monitoring Screen

Figure 5-12 Physio Relationship Screen

SVV Filtering Exceeded Indicator

Audible alarm indicator

Continuous % ChangeIndicator

Target StatusIndicator

Parameter Value

Units

Parameter Name

Advanced hemodynamic parameters can alert you to hemodynamic instabilityThe ClearSight system provides you access to advanced hemodynamic parameters, including continuous noninvasive blood pressure, allowing you to evaluate hemodynamic instability and guide appropriate treatment.

Episodes of hypotension may be decreased through continuous monitoring Cleveland Clinic researchers recently showed that continuous noninvasive monitoring reduced the amount of intraoperative hypotension by nearly half (P = 0.039) when compared to intermittent blood pressure monitoring.2

Early detection of hypotension by continuous hemodynamic monitoring allows for timely remedial actions, thereby reducing intraoperative hypotension.2

Enabling you to proactively manage intraoperative hypotension (IOH) Clarity through advanced hemodynamic parameters CO, SV, SVV, and SVR can help you determine if the cause of IOH is preload, afterload, or contractility.

If the underlying cause of hemodynamic instability is related to decreased flow, continuous parameters can help you determine whether fluid is the appropriate therapy.

Additionally, continuous monitoring of advanced hemodynamic parameters can help you determine whether to augment vascular volume, reduce anesthetic administration, or use vasopressors or inotropes.2

Enables you to make proactive clinical decisions based on insights into pressure and flow parameters.

Physio-Relationship Screen

Blood flow through the tissue (capillary blood flow)

Heart Rate Stroke Volume

Tissue Perfusion

Cardiac Output

=

Tissue Perfusion Pressure

= Pressure at

arterial end (PA )

Pressure at

venous end (PV)-

Artery (PA)

Vein (PV)

SV

Preload Contractility Afterload

SV

Continuous assessment of pressure and flow parameters offers decision support to help proactively manage the duration and severity of IOH episodes.

Page 5: Noninvasive advanced hemodynamic monitoring · 2020-03-11 · See Chapter 14, "EV1000 Clinical Platform NI AdvancedFeatures" , for more infor-mation. Physio Relationship The Physio

When managing perfusion, stroke volume can be optimized using the patient’s own Frank-Starling curve.

The patient’s response to a fluid challenge may be assessed by changes in SV, as indicated by location on the curve. Dynamic and flow-based parameters provide a comprehensive hemodynamic assessment and may help guide individualized fluid administration to avoid over and under resuscitation.3

For additional clarity into whether a ventilated patient will respond positively to fluid, stroke volume variation (SVV) has been proven to be a highly sensitive and specific indicator of preload responsiveness.4-7

Hemodynamic parameters help you manage volume administration Advanced hemodynamic parameters provided by the ClearSight system may be used in perioperative goal-directed therapy (PGDT) protocols.

PGDT analytics is a PC only desktop application designed to organize and visualize data download files from the EV1000 clinical platform.

Helps you comply with 3-hour and 6-hour CMS sepsis bundle guidelines The noninvasive ClearSight system allows continuous assessment of your patient’s physiological needs and helps you recognize hemodynamic instability from sepsis.8

Manage the flow component of perfusion to help you guide individual fluid management.

Frank-Starling relationship between preload and stroke volume (SV)

Preload

Hypo Hyper

Target Zone

Stro

ke v

olu

me

The ClearSight finger cuff can be used to measure flow-based parameters continuously prior to, during, and after the fluid administration portion of the 3-hour and 6-hour CMS sepsis bundles.

Page 6: Noninvasive advanced hemodynamic monitoring · 2020-03-11 · See Chapter 14, "EV1000 Clinical Platform NI AdvancedFeatures" , for more infor-mation. Physio Relationship The Physio

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Edwards, Edwards Lifesciences, the stylized E logo, ClearSight, and EV1000 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. PP--US-3530 v2.0

Edwards Lifesciences • One Edwards Way, Irvine CA 92614 USA • edwards.com

References1. Truijen, J et al. Noninvasive Continuous Hemodynamic Monitoring. Journal of Clinical Monitoring and Computing 2012;26(4):267–268.2. Maheshwari, K et al. A Randomized Trial of Continuous Noninvasive Blood Pressure Monitoring During Noncardiac Surgery. Anesthesia & Analgesia,

2018 Aug;127(2)424-431.3. Cannesson, M. (2010) Arterial pressure variation and goal-directed fluid therapy. Journal of Cardiothoracic and Vascular Anesthesia, 24(3), 487-97.4. McGee, W. T. (2009). A simple physiologic algorithm for managing hemodynamics using stroke volume and stroke volume variation: Physiologic

optimization program. Journal of Intensive Care Medicine, 24(6), 352-360.5. Peng, K., Li, J., Cheng, H., Ji, FH. (2014) Goal-directed fluid therapy based on stroke volume variations improves fluid management and gastrointestinal

perfusion in patients undergoing major orthopedic surgery. Medical Principles and Practice, 23(5), 413-20.6. Berkenstadt, H., et al. (2001) Stroke Volume Variation as a Predictor of Fluid Responsiveness in Patients Undergoing Brain Surgery.

Anesthesia & Analgesia, 92, 984-9.7. Cheng L, Fu-qing L, et al. Stroke Volume Variation for Prediction of Fluid Responsiveness in Patents Undergoing Gastrointestinal

Surgery. Int J of Med Sciences. (2013): 148-155.

8. Marik, et al: Hemodynamic parameters to guide fluid therapy. Annals of Intensive Care 2011 1:1.

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The ClearSight system is comprised of the ClearSight finger cuff and EV1000 clinical platform.

1. EV1000 monitor2. EV1000 pump-unit3. Pressure controller4. ClearSight finger cuff5. Heart reference sensor

Enabling proactive clinical decisions.For more than 40 years, Edwards Lifesciences has been helping you make proactive clinical decisions in advancing the care of acutely ill patients across the continuum of care. Through ongoing collaboration with clinicians, providing continuous education, and our dedication to purposeful innovation, Edwards continues to develop smart hemodynamic management solutions that enable proactive decision support.

Know More. Know Now.

Visit Edwards.com/ClearSight or contact your Edwards representative.

ClearSight finger cuff small multi pack

ClearSight finger cuff medium multi pack

ClearSight finger cuff large multi pack

EV1000 clinical platform

CSCS

CSCM

CSCL

EV1000NI

Connectivity via IFM out through a serial connection, HL7 through an Ethernet connection or HL7 Integration Engine.

ModelDescription

ClearSight system

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