Critical Care Product Catalogue - Edwards...

Critical CareProduct Catalogue

ClearSightFloTrac

PreSep/PediaSatVolumeView

Swan-GanzTruWave

VAMPEV1000

SystemSensorOximetry CatheterSetCatheterPressure TransducerClosed Blood Sampling SystemClinical Platform

2

VolumeView Set(CO, SV, SVV, GEDV, GEF and EVLW)

TruWave Transducer and VAMP System (Arterial Pressure, CVP, RAP, PAP and ICP)

ClearSight System (CCO, SV and SVV)

The Continuum of Critical CareThe critical care portfolio of Edwards Lifesciences consists of tools for monitoring patients of varying clinical complexity. Each product and system employs advanced technologies to provide optimum1 insight and maximum2 efficiency within the clinical workflow. The following products and more are covered within this catalogue:

ClearSight System

The ClearSight system provides continuous hemodynamic monitoring to a broader patient population. The ClearSight Nonin-vasive System displays key hemodynamic parameters including; CO, SV, SVV, SVR, cBP.

VolumeView Set

Intended for use in treating acutely ill patients, the VolumeView set provides informative volumetric parameters (EVLW, PVPI, GEDV and GEF) that can be used specifically in the treatment of pulmonary oedema, acute lung injury (ALI) or acute respiratory distress syndrome (ARDS).

PreSep and PediaSat Oximetry Catheter

Continuous ScvO2 monitoring with the PreSep and PediaSat oximetry catheters can reveal occult tissue hypoxia that tradi-tional vital signs can miss3-9.

FloTrac Sensor

Providing the latest standards in ease-of-use, practicality and continuity, the FloTrac system provides continuous cardiac output (CCO), stroke volume (SV), stroke volume variation (SVV), and systemic vascular re-sistance (SVR) through an existing arterial line.

Monitoring Platforms

The EV1000 clinical platform presents a holistic view of clinically validated parame-ters provided by the ClearSight system, the FloTrac sensor, the PreSep and PediaSat oximetry catheters and the VolumeView set.

Swan-Ganz Catheter

Thermodilution PA catheters (base and advanced technology) providing right heart information to determine hemody-namic pressures, volumes, CO and mixed venous oxygen saturation (SvO2).

VAMP System

Safe, easy and accurate blood sampling systems that offer the flexibility to fulfill the needs of the OR and ICU.

TruWave Transducer

A high-fidelity disposable pressure trans-ducer with an ergonomically designed cable connector and convenient snap-tab.

3

ClearSight System p 4

FloTrac Sensor p 6

PreSep & PediaSat Oximetry Catheters p 10

VolumeView Set p 16

Monitors & Accessories p 52

Notes p 60

TABLE OF CONTENTS

Swan-Ganz Catheters p 20

Pressure Monitoring p 36

4

ClearSight System

1 ClearSight System

The ClearSight system extends continuous hemodynamic monitoring to a broader patient popula-tion, including moderate to high-risk patients10-20. By leveraging proven ccNexfin system technology, the ClearSight system provides clinicians clarity without the barriers of complexity or invasiveness.

The ClearSight system is a simple, noninvasive approach to monitoring key hemodynamic parameters:

• Stroke Volume (SV)

• Stroke Volume Variation (SVV)

• Cardiac Output (CO)

• Systemic Vascular Resistance (SVR)

• Continuous Blood Pressure (BP)

2

1

5

3

EV1000 Clinical Platform NI:

1 - EV1000 Monitor2 - EV1000 Pump-Unit3 - Pressure Controller4 - ClearSight Finger Cuff5 - Heart Reference Sensor

Simple application10

The ClearSight system quickly connects to the patient by wrapping an inflatable cuff around the finger, giving you continuous noninvasive hemodynamic information.

Leverages validated technologyUsed as the standard for monitoring in space for decades21, ccNexfin noninvasive technology (volume clamp 22, Physiocal 12) has been extensively validated against gold standard monitoring technologies 16,17,19,20.

Advanced hemodynamic monitoring extended to moderate-risk patientsIncluding elderly or obese patients 10, 20, 24 — enabling you to make more informed decisions regarding volume administration 25.

4

5

ClearSight System

2 Educational Resources 31

CatalogueNumber

Description Pack Size

CSCS ClearSight Finger Cuff Small Multi Pack (Green) 5

CSCM ClearSight Finger Cuff Medium Multi Pack (Blue) 5

CSCL ClearSight Finger Cuff Large Multi Pack (Red) 5

CatalogueNumber


EV1000NI EV1000 Clinical Platform NI 1

EVNIUPG Noninvasive upgrade to EV1000A (excludes monitor) 1

EVHRS Heart Reference Sensor 1

EVHRSBP Heart Reference Sensor Body Pads 100

EVPMAC Patient Monitor Adaptor Cable 1

PC2CCC Pressure Controller Cuff Connector Cap 1

PC2B Pressure Controller Band Multi Pack 5

• ClearSight System Brochure AR11578

• ClearSight System Technology Overview AR10482

• ClearSight System Setup Guide AR10424

• ClearSight System Technology Animation www.edwards.com/eu/clearsight

• ClearSight System Training Video www.edwards.com/eu/clearsight

ClearSight System Disposables

ClearSight System & Accessories

6

Sensor Vent Port

Snap-Tab Device

To EV 1000 monitor (green)

ToIV Set

To PatientTo Pressure monitor (red)

FloTrac Sensor

1 FloTrac Sensor

The FloTrac sensor is a less invasive hemodynamic monitoring device that provides key flow para-meters (CO, SV, SVV, SVR) from an existing arterial catheter using continuous automatic vascular tone adjustment 26,27.

The FloTrac sensor can be used with the Vigileo monitor or the EV1000 clinical platform. The complete system will calculate and display key flow parameters.

The FloTrac sensor is accurate, easy to use and less invasive 28,29.

• Connects to existing arterial catheter.

• Requires no additional catheters, boluses or chemical indicators, enabling rapid set-up.

• Continuously monitors changes in the patient’s vascular tone (compliance and resistance) 30.

• Validated against the clinical gold standard Swan-Ganz pulmonary artery catheter 26.

• Compatible with the Vigileo monitor and the EV1000 clinical platform.


• FloTrac sensor brochure AR10320

• FloTrac sensor 4.0 Algorithm AR10317

• FloTrac sensor pocket card AR08052

• Setup guide: FloTrac/Vigileo AR07449

• Setup Guide: FloTrac/EV1000 AR07457

• In-Service Video www.edwards.com/eu/flotracinservice

7

CatalogueNumber

Length A(cm)*

Length B(cm)*


MHD6R 120 30 FloTrac sensor (150 cm) pressure line 1

MHD6AZR 90 60 FloTrac sensor (150 cm) pressure lineand VAMP adult system

1

MHD8R 180 30 FloTrac sensor (210 cm) pressure line 1

MHD6R5 120 30 FloTrac sensor (150 cm) pressure line 5

MHD6AZR5 90 60 FloTrac sensor (150 cm) pressure lineand VAMP adult system

5

MHD8R5 180 30 FloTrac sensor (210 cm) pressure line 5

APC09 FloTrac sensor connecting cable 1

FloTrac Sensor - Disposables and Accessories

FloTrac Sensor

*Lenghts are rounded up from inches to centimeters.

Total length274

AA

BB

8

Cardiac Output / Cardiac Index

Pulse Rate SV/SVI

Preload Afterload Contractility

∆ SV Response SVR/SVRI

SVV

FloTrac Sensor

1 Clinical Application of Flow Parameters 32

2 Outcome studies performed with the ClearSight System

ClearSight System

Author& Year

Title Surgery type

Garson 2014 56

Implementation of a total joint replacement-focused perioperative surgical home: a management case report

Orthopedic

Chen2012 18

Impact of non invasive and beat-to-beat arterial pressure monitoringon intraoperative hemodynamic management

AbdominalOrthopedic

9

3 Outcome studies performed with the FloTrac Sensor

FloTrac Sensor ClearSight System

Author& Year

Title Surgery type

Colantonio2015 35

A randomized trial of goal directed vs standard fluid therapy in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

Abdominal

Peng2014 23

Goal-directed fluid therapy based on stroke volume variations im-proves fluid management and gastrointestinal perfusion in patients undergoing major orthopaedic surgery.

Orthopedic

Zeng 2014 49

The influence of goal-directed fluid therapy on the prognosis of elderly patients with hypertension and gastric cancer surgery.

Abdominal

Zheng 2013 2

Goal-directed fluid therapy in gastrointestinal surgery in older coronary heart disease patients: randomized trial

Abdominal

Zhang 2013 59

Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thora-coscopy lobectomy operations: a pilot study

Thoracic

Ghneim 2013 57

Goal directed fluid resuscitation decreases time for lactate clearance and facilitates early fascial closure in damage control surgery

Damage controlOpen

Abdomen

Scheeren 2013 50

Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study

Abdominal

Ramsingh 2013 33

Outcome impact of goal directed fluid therapy during high risk abdomi-nal surgery in low to moderate risk patients: a randomized controlled trial

Abdominal

Cecconi 2011 58

Goal-directed haemodynamic therapy during elective total hip arthro-plasty under regional anaesthesia

HipOrthopedic

Benes 2010 54

Intraoperative fluid optimization using stroke volume variation in high risk surgical patients: results of prospective randomized study

AbdominalVascular

10

Proximal Lumen

Distal Lumen

Medial Lumen

Suture Ring

Suture Wings

Sheath

Optical ModuleConnector

PreSep & PediaSat Oximetry Catheters

1 PreSep Oximetry Catheter 3,5,36

PreSep oximetry catheters are triple lumen central venous catheters with the added capability for continuously monitoring central venous oxygen saturation (ScvO2). It is integral to Early Goal-Directed Therapy (EGDT) for the management of sepsis. EGDT yields significant reductions in sepsis-related mortality 34.

• Continuous ScvO2 monitoring to assess the balance of oxygen delivery and consumption.

• Easy to insert using same insertion technique as that of central lines.

• Pressure monitoring (Central Venous Pressure) and high flow rates.

• Perioperative hemodynamic optimization based on ScvO2.

• Compatible with Edwards oximetry monitors (*) and optical module, and now available

with the Philips SO2 module.

(*) Edwards oximetry monitors include Vigileo and Vigilance II monitors and EV1000 clinical platform.

11

CatalogueNumber

Length(cm)

No. ofLumens

FrenchSize


X3820HS 20 3 8.5 PreSep oximetry catheter (Vigileo, EV1000)

1

X3820HSP 20 3 8.5 PreSep oximetry catheter (Philips SO2 module)

1

CatalogueNumber

Length(cm)


OM2E 335 Edwards oximetry module 1


Triple Lumen PreSep Catheter

PreSep Catheter - Accessory

12


2 PediaSat Oximetry Catheter 37-40

PediaSat oximetry catheters are pediatric central venous catheters with the added capability forcontinuously monitoring central venous oxygen saturation (ScvO2).

• Continuously monitors ScvO2 to assess the balance of oxygen delivery and consumption.

• Sized for pediatrics.

• Easy to insert using same insertion technique as that of central lines.

• Offers high flow rates and convenient administration of fluids.

• Compatible with Edwards oximetry monitors (*) and optical module, and now available

with the Philips SO2 module.

(*) Edwards oximetry monitors include Vigileo and Vigilance II monitors and EV1000 clinical platform.

13

CatalogueNumber

Length(cm)

No. ofLumens

FrenchSize


XT358HSP 8 3 5.5 PediaSat oximetry catheter (Philips SO2 module)

1


1

CatalogueNumber

Length(cm)

No. ofLumens

FrenchSize



1


1

CatalogueNumber

Length(cm)


OM2E 335 Edwards oximetry module 1

Double Lumen PediaSat Catheter

Triple Lumen PediaSat Catheter

PediaSat Catheter - Accessory


14

Oxygen Delivery

Cardiac Output

Optimal HR

BleedingFluid Shift

VascularResistance

HeartDisease

Preload Afterload Contractility

HeartRate

StrokeVolume

BleedingHemodilution

Anemia

SaO2FiO2

Ventilation

FeverAnxiety

PainShivering

Muscle Activity

Hemoglobin Oxygenation Metabolic Demand

Oxygen Consumption

ScvO2

70

....

... .

. .. . . . . . . . . . . .....

Mo

rtal

ity R

ate

(%)

Control EGDT

-52%

50

40

30

20 Mul

tiple

Org

an D

ysfu

nctio

n S

core

(M

OD

S)

Control EGDT

-25%

6.5

6

5.5

5

4.5

3 Clinical Application of ScvO2 41

In sepsis management

RIVERS et al. 34

Early goal-directed therapy (EGDT) has been used for severe sepsis and septic shock in the intensive care unit. This approach involves adjustments of cardiac preload, afterload, and contractility to balance oxygen delivery with oxygen demand. Targeting ScvO

2 at a value 70% and measuring it continuously,

together with other parameters, helps with the application of the EGDT treatment protocol.


15


ScvO2

73

....

... .

. .. . . . . . . . . . . .....

Org

an F

ailu

res

Control GDT

67%

30

20

10

0 Ho

spita

l Day

s

Control GDT

16%

14

13

12

11

10

PreSep Oximetry Catheter

The security of an early warning

PediaSat Oximetry Catheter

The smaller the patient, the earlier you need to know.


• PediaSat catheter brochure AR05978

PreSep Oximetry Catheter

Perioperative optimization

PediaSat Oximetry Catheter

DONATI et al.42

A trial was performed in nine hospitals in Italy on 135 high-risk patients scheduled for major abdominal surgery. The patients of the GDT group were managed to keep O2ER < 27% (or ScvO2 >73%). Early treatment directed to maintain O2ER < 27% reduced organ failures and hospital stay.

• PreSep catheter brochure E2639/02-12/CC

• Setup Guide: PreSep/Vigileo AR07450

• Setup Guide: PreSep/EV1000 AR07451

• In-Service Video www.edwards.com/eu/presepinservice

• EGDT e-learning module www.edwards.com/eu/EGDT

16

The VolumeView set consists of 45-47:

VolumeView Set

1 VolumeView Set

The next advancement in volumetric parameters: the VolumeView set from Edwards Lifesciences allows the clinician to access valuable volumetric information needed to manage the critically ill patient in the ICU.

The VolumeView set:

• Provides informative volumetric parameters (EVLW, PVPI, GEDV and GEF). • Can be used specifically in the treatment of pulmonary oedema, acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) 43,44.

• The volumetric parameters are provided via transpulmonary thermodilution (TPTD).

The VolumeView sensor, which allows mea-surement of continuous hemodynamic para-meters and can also be calibrated through intermittent transpulmonary thermodilution.

The VolumeView femoral artery catheter, which is soft and flexible allowing easier inser-tion and helping to reduce vessel trauma.

The VolumeView thermistor manifold, which allows closed bolus delivery helping minimise infection risk.

1

3

2

1

2

3

17 17

CatalogueNumber

FrenchSize

Product Description Pack Size

VLV8R520 5 20 cm catheter / VolumeView sensor /Venous Injectate Kit / TruWave

1


5


1


5

VLVFC5205 5 20cm VolumeView Femoral Catheter 5

CatalogueNumber

Product Description Pack Size

VLV8R5 VolumeView sensor 5

VLVCVT5 VolumeView venous injectate kit 5

VolumeView Set

VolumeView Set - All Product Codes

VolumeView Set - All Product Codes

1

3

2

18

2 Clinical Application of Volumetric Parameters

Evolving beyond numbers: the Physio Relationship screen helps identify the source of problem clearly through the hierarchy of parameters. The Physiology screen enables quick treatment decision-making through visual clinical decision support.

The VolumeView set from Edwards Lifesciences in combination with the EV1000 clinical platform enables the display of valuable volumetric parameters in a meaningful way. Delivered via the EV1000 clinical platform, the VolumeView set is able to offer you a clear and visual depiction of patient physiologic status – including extravascular lung water (EVLW).

Applications in the intensive care unit.

The VolumeView set can help bring clarity in determining possible causes of hemodynamic instability, pulmonary oedema and cardiac dysfunction if used at the right time in the right patient 34,43.

• Severe sepsis

• Septic shock

• ARDS/ALI

• Cardiogenic shock

• Severe burns

Applications in the surgical environment.

The VolumeView set can also be used in some perio-perative situations to provide valuable hemodynamic information:

• Liver surgery

• Hepatic surgery

• Cardiac surgery

• Transplantation

VolumeView Set

19

• VolumeView set brochure (E4711/03-14/CC)

• Parameters card (AR10523)

VolumeView Set


• The VolumeView set is intended for use in treating your acutely ill patients, providing informative volumetric parameters 46-48: • EVLW - Extra vascular Lung Water • PVPI - Pulmonary Vascular Permeability Index • GEDV - Global End Diastolic Volume • GEF - Global Ejection Fractio

• The volumetric parameters are provided via transpulmonary thermodilution (TPTD) 46-48.

• Set-up guide (AR07460)

20

The Single, Continuous and Comprehensive Solution for Assessing Hemodynamic Status

Oxygen delivery is the key to patient survival

Oxygen Flow-Consumption Diagram

Swan-Ganz CCOmbo V VIP catheter Model: 777HF8

The ability to take continuous measurements of two or more crucial physiological parameters will make the PAC a unique monitoring tool for years to come.

–Jean-Louis Vincent. A reappraisal for the use of pulmonary artery catheters.

Critical Care, 2006;10(Suppl 3):S1.

PAOP

Celebrating 40 years of collaboration

The Single, Continuous and ComprehensiveSolution for Assessing Hemodynamic Status

Hemodynamic Monitoring - Swan-Ganz Catheters

21


*All model numbers with an “H” contain AMC THROMBOSHIELD coating (an antimicrobial † heparin coating) . Antimicrobial activity associated with AMC THROMBOSHIELD coating has been demonstrated using in vitro diffusion agar assays against the following organisms: Staphylococcus epidermidis, Staphylococcus aureus, Streptococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, and Acinetobacter calcoaceticus.

† Decreases viable microbe count on surface of product during handling and placement.

2 Swan-Ganz CCO Catheters

Swan-Ganz CCO catheters allow for continuous calculation of cardiac output.

1 Swan-Ganz CCOmbo CathetersSwan-Ganz CCOmbo catheters are designed to enable continuous monitoring of hemodynamic pressures, continuous cardiac output, mixed venous oxygen saturation (SvO2), and continuous end-diastolic volume (EDV).

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size 744HF75 110 6 7.5F Continuous cardiac output catheter with SvO2* 1

746HF8 110 7 8F Continuous cardiac output VIP catheter with SvO2* 1

774F75 110 6 7.5F Continuous cardiac output catheter with SvO2and EDV 1

774HF75 110 6 7.5F Continuous cardiac output catheter with SvO2 and EDV* 1

777HF8 110 7 8F Continuous cardiac output VIP catheter with SvO2 and EDV* 1

Thermal FilamentConnector

Thermistor Connector

Balloon Inflation Valve

Thermistor@ 4 cm

Balloon

Thermal Filament

PA DistalLumen

VIP Port @ 30 cmProximal InjectatePort @ 26 cm

Proximal InjectateLumen Hub

VIP Lumen HubPA Distal Lumen Hub

Optical ModuleConnector

CCOmbo 777

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size 139F75 110 6 7.5F Continuous cardiac output (CCO) VIP catheter 5

139HF75P 110 6 7.5F Continuous cardiac output (CCO) VIP catheter* 5

177HF75 110 6 7.5F Continuous cardiac output catheter with EDV* 1


PA DistalLumen Hub



Thermal FilamentConnector

VIP Lumen HubProximal InjectatePort @ 26 cm

VIP Port @ 30 cm

Thermal FilamentThermistor@ 4 cm

PA Distal Lumen

Balloon

CCO 139

22


3 Swan-Ganz Oximetry Thermodilution Catheters


Distal LumenHub


Balloon Inflation ValveOptical ModuleConnector

RV PaceportLumen Hub(Pacing/Infusion)

RV Port @ 19 cm

Proximal InjectatePort @ 30 cm

Thermistor

Distal Lumen

Balloon

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size 631HF55 75 5 5.5F Pediatric oximetry thermodilution catheter* 1

040HF4 40 2 4F Small French oximetry catheter* 1

015HF4 25 2 4F Small French oximetry catheter* 1

741HF75P 110 5 7.5F Swan-Ganz Oximetry 1 Thermodilution Catheter*

780HF75P 110 6 7.5F Swan-Ganz Oximetry Paceport 1 Thermodilution Catheter*

782HF75 110 6 7.5F Swan-Ganz VIP Oximetry 1 Thermodilution Catheter*

Swan-Ganz oximetry thermodilution catheters continuously monitor mixed venous oxygen saturation.

• Swan-Ganz oximetry thermodilution catheters enable monitoring of hemodynamic pressures, cardiac output, and continuous mixed venous oxygen saturation (SvO2).

• Swan-Ganz VIP oximetry thermodilution catheters provide an additional (VIP) lumen that allows for continuous infusion.

• Swan-Ganz Paceport oximetry thermodilution catheters are intended for use in patients who require hemodynamic monitoring when temporary transvenous pacing is anticipated.

• The oximetry thermodilution catheters with the suffix ”P” are compatible with both the Vigilance II monitor as well as the Philips IntelliVue SO2 module.



SvO2 780

23


4 Swan-Ganz Thermodilution Catheters

5 Swan-Ganz VIP & VIP+ Catheters

Swan-Ganz thermodilution catheters are designed to rapidly determine hemodynamic pressures and cardiac output.

• The Swan-Ganz VIP catheters have an extra lumen in addition to the standard distal and injectate lumens to provide direct access to the right atrium.

• The Swan-Ganz VIP+ catheters are equipped with two right atrium lumens.

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size 132F5 75 4 5F Standard thermodilution catheter 1

096F6P 110 4 6F Standard thermodilution catheter 5

131F7P 110 4 7F Standard thermodilution catheter 5

131HF7P 110 4 7F Standard thermodilution catheter* 5

131HVF7P 110 4 7F Standard thermodilution catheter 5 with contamination shield*

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size

831F75P 110 5 7.5F VIP Swan-Ganz catheter 5

831HF75P 110 5 7.5F VIP Swan-Ganz catheter* 5

831HVF75P 110 5 7.5F VIP Swan-Ganz catheter with contamination shield* 5

834HF75 110 6 7.5F VIP+ Swan-Ganz catheter* 5



ThermistorConnector


Distal Lumen Hub

Balloon Inflation ValveProximal InjectatePort @ 30 cm Balloon

Distal Lumen

Thermistor

MODEL 131

ThermistorConnector


PA DistalLumen Hub

Balloon InflationValve (Gate Valve)


Thermistor

Balloon

PA DistalLumen

RA Infusion Lumen

RV Infusion Lumen HubRA InfusionPort @ 31 cm

RV InfusionPort @ 19 cm

MODEL 834

Swan-Ganz thermodilution VIP & VIP+ catheters are designed for a variety of hemodynamic applications.

24


6 Swan-Ganz Non-Latex Catheter and Introducer

Physicians have all the components needed to insert a Swan-Ganz catheter without latex components offered together in the same package.

• Catheter and introducer sheath are packaged together for maximum convenience.• Swan-Ganz ControlCath thermodilution catheters are made from a proprietary polymer blend and offer improved

torque control and maneuverability over the standard Swan-Ganz thermodilution catheter.• Swan-Ganz ControlCath catheters offer improved column strength for easy passage through the introducer

sheath.• The Swan-Ganz ControlCath thermodilution catheter “C-Tip” allows for both femoral vein or superior vena

cava (SVC) approaches.• Swan-Ganz ControlCath catheters will not lose their torque properties at body temperature as found with

thermodilution catheters made from PVC, resulting in excellent handling characteristics and consistent wave-form fidelity throughout the procedure.

No latex components or PVCThe synthetic Swan-Ganz ControlCath thermodilution catheters do not contain any natural latex rubber ornatural dry rubber components, including the balloon, which is made from a proprietary synthetic elastomer.

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size S9FC146F7 110 4 7F Non-latex catheter and introducer 1

25


7 Swan-Ganz Femoral Vein Insertion Catheters


Distal Lumen Hub

Injectate Lumen Hub



Thermistor

Distal Lumen Port

Balloon


Thermistor

Distal Lumen Port

Balloon

“S-Tip”

“C-Tip”


Distal Lumen Hub

Injectate Lumen Hub



Thermistor

Distal Lumen Port

Balloon


Thermistor

Distal Lumen Port

Balloon

“S-Tip”

“C-Tip”

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size

141F7 110 4 7F Hi-Shore catheter 5141HF7P 110 4 7F Hi-Shore catheter* 5

151F7 110 4 7F “S-Tip” catheter 1

151HF7 110 4 7F “S-Tip” catheter* 1

C144F7 110 4 7F ControlCath catheter, polymer blend, “C-Tip” 1

C144HF7 110 4 7F ControlCath catheter, polymer blend, “C-Tip”* 1

S144F7 110 4 7F ControlCath catheter, polymer blend, “S-Tip” 1

S144HF7 110 4 7F ControlCath catheter, polymer blend, “S-Tip”* 1

Swan-Ganz ControlCath, Hi-Shore and CardioCath catheters offer improved torque control and maneuverability.

• Swan-Ganz ControlCath thermodilution catheters are made from a proprietary polymer blend and will not lose their torque properties at body temperature.

• Swan-Ganz Hi-Shore thermodilution catheters are slightly stiffer than the standard Swan-Ganz catheter, and may be used when more torque control and maneuverability is needed.

• The “S-Tip” configurations are designed specifically for femoral vein insertion.

• The “C-Tip” configurations allow for both femoral vein or superior vena cava (SVC) approaches.



S144/C144

26


8 Swan-Ganz Thermodilution Pacing Catheters

Swan-Ganz thermodilution pacing catheters can perform right atrial, pulmonary arterial, and pulmo-nary artery wedge pressure measurements; as well as blood sampling, solution infusion, and cardiac output measurements.

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size D200F7 110 4 7F Pacing-TD catheter 1

D200HF7 110 4 7F Pacing-TD catheter* 1



• Multi-functional thermodilution catheters that contain three atrial and two ventricular electrodes for atrial and ventricular pacing, and antrioventricular (A-V) sequential pacing.

• Fast to setup with no need to insert probes in order to pace.

ThermistorConnector


ProximalAtrial

Central AtrialDistal Atrial

Distal Ventricular

Proximal Ventricular

Balloon Inflation Hub

Distal Lumen Hub

Atrial ElectrodesProximal InjectatePort

Stylet AnchorBushing

VentricularElectrodes

Balloon

Thermistor(Back Side)

#5 #4 #3#2

#1

#5#4 #3

#2#1

PACING TD 200

27




9 Swan-Ganz Bipolar Pacing Catheters

• Effective bipolar ventricular pacing when hemodynamic monitoring is not needed.

• Has two electrodes, one at the catheter tip and one 1 cm proximal, providing capabilities for bipolar pacing.

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size D97120F5 90 3 5F For SVC insertion, catheter only (straight tip) 1

D97130F5 90 3 5F For Femoral insertion, catheter only (“J-Tip”) 1

Swan-Ganz bipolar pacing catheters are designed for temporary right ventricular endocardial pacing. The balloon tip facilitates insertion by flow-direction. A “J-Tip” configuration is available for femoral insertion.

Gate Valve

Distal Electrode Connector

Proximal Electrode

Distal Electrode

Balloon

ProximalElectrodeConnector

D97 Bipolar Pacing

28


11 Swan-Ganz Monitoring Catheters


Distal LumenHub

PA Distal Lumen Port

Balloon

Proximal Lumen Hub


Distal Lumen Hub

PA Distal Lumen Port

Balloon

Double Lumen Monitoring Catheter

Triple Lumen Monitoring Catheter

Proximal Lumen Port

Swan-Ganz flow-directed monitoring catheters provide a rapid, simple, and effective method for monitoring right heart pressures.

• In double lumen catheters, the lumen terminates at the distal tip of the catheter and is used to monitor pulmonary artery and wedge pressures.

• Triple lumen monitoring catheters have the same capabilities as double lumen catheters with an additional (proximal) lumen for central venous pressure monitoring.

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size 110F5 110 2 5F Double lumen catheter 5

123F6P 110 2 6F Double lumen catheter 5

111F7P 110 2 7F Double lumen catheter 5

114F7P 110 3 7F Triple lumen catheter, 30 cm exit proximal lumen 5

114 MONITORING

10 Swan-Ganz Paceport Catheters and Chandler ProbesSwan-Ganz Paceport catheters can be used for simultaneously obtaining hemodynamic parameters and reliable ventricular pacing on demand by using the Chandler V-Pacing and/or the Flex-Tip A-Pacing probes.

• The ability to be prepared for any of the numerous indications for temporary cardiac pacing, many of which cannot be diagnosed at the time of catheter selection and insertion.

• Fast and easy pacing access that requires only one insertion site, thus reducing the risk of complications.

Catalogue Length (cm) No. of French Description PackNumber Lumens Size Size 931F75 110 5 7.5F Ventricular paceport thermodilution catheter 1

931HF75 110 5 7.5F Ventricular paceport thermodilution catheter* 1

D98100 135 none 2.4F Chandler transluminal V-pacing probe 1

D98100H 135 none 2.4F Chandler transluminal V-pacing probe* 1

931 PACEPORT PACING PROBE 100

Tuohy-BorstAdapter

Contamination Sheath(Slips over Tuohy-Borst Adapter)

Green CoatingNOTE: Depth marksindicated on clearnumbered RV lumencatheter extension.

ReferenceMarker

Pulse GeneratorConnectors

ProximalElectrode

DistalElectrode

Thermistor


Distal Lumen HubProximal InjectateLumen Hub

Balloon InflationValve Balloon

Distal Lumen


RV PaceportLumen Hub(Pacing/Infusion)

RV Port@ 19 cm

29

Hemodynamic Monitoring - CO-Set+ System

12 CO-Set+ Closed Injectate Delivery SystemGet a better handle on cardiac output.

CO-Set+ closed injectate delivery system works effectively with room temperature or cold injectate for the measurement of bolus thermodilution cardiac output.

• Established contamination shield is integrated into the reinforced plunger to help close the system. • Palm pad provides a large surface area and contoured shape designed for comfort, facilitating smooth and

rapid bolus injection. • Multi-position finger grips are designed for most hand sizes and a variety of injection techniques. • Volume-limited syringe (10cc) aids in obtaining accurate cardiac output by simplifying filling and eliminating

the variability from differences in filling techniques.

CO-Set+ System IcedCO-Set+ System Room Temperature

Catalogue Description Pack SizeNumber 93600 CO-Set+ Delivery System for Cold Injectate 10

93610 CO-Set+ Delivery System for Room Temperature Injectate 10

93650 CO-Set+ Syringe – 10cc 5

93505 CO-Set+ Flow-Through Injectate Housing 8

93520 CO-Set+ Cooling Containers 6

93521 CO-Set+ Cooling Container Bracket for IV Pole 1

93522 CO-Set+ In-Line Injectate Temperature Probe for Edwards Cardiac Output Computers and most Mennen and Spacelabs Cardiac Output Computers – Cable Length 240cm 1

93523 CO-Set+ In-Line Injectate Temperature Probe for use with most Hewlett Packard/Philips Cardiac Output Monitors – Cable Length 240cm 1

93528 CO-Set+ In-Line Injectate Temperature Probe for use with most Nihon Koden Cardiac Output Monitors – Cable Length 240cm 1

Our CO-Set+ portfolio is not limited to these products and accessories. For more information contact your Edwards sales representative or call our Customer Service office in your country.

30

AVA 3Xi DeviceTwice the convenience. A one-of-a-kind design.

Every day we have one goal: to focus our

energies on developing better products that

will help you provide the best patient care.

With the introduction of the Edwards

Advanced Venous Access (AVA) device

came a new approach to central

venous access.

Engineered specifically for routine

cardiac patients, the Edwards AVA 3Xi

device meets all your central venous access

needs. The first triple lumen device with a

detachable introducer valve — all in one.


31

Hemodynamic Monitoring - Central Venous Access

13 AVA 3Xi Device

Offers advantages of a triple lumen device, with three infusion lumens, and convertibility to insert a Swan-Ganz catheter.

• Transitions from an introducer to a triple lumen device with detachable introducer valve as treatment changes. • A Swan-Ganz catheter can be inserted for hemodynamic monitoring if needed. • Provides multiple central venous access in a single insertion site for increased efficiency and patient comfort. • With AMC Thromboshield treatment, an antimicrobial* heparin coating.

AVA 3Xi Device Catalogue Sheath No. French Description Pack SizeNumber Length (cm) of Lumens Size

M3L85FHSI 11 3 8.5F AVA 3Xi Device with Heparin and 5 with injection caps*

AVA 3Xi Device - Accessories Catalogue Length (cm) Description Pack SizeNumber

IOBCAP 2 Obturator with short Snap Lock Design 10 for use with 6-9F Introducers

MCL80G2 80 Locking contamination shield for AVA 3Xi 10

*All model numbers with an “H” contain Edwards AMC THROMBOSHIELD coating (An Antimicrobial† Heparin Coating). Antimicrobial activity associated with AMC THROMBOSHIELD coating has been demonstrated using in vitro diffusion agar assays against the following organisms: Staphylococcus epidermidis, Staphylococcus aureus, Streptococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, and Acinetobacter calcoaceticus.

†Decreases viable microbe count on surface of product during handling and placement.

Proximal Lumen Slide Clamp

Slide Clamp

Anti-Bleed BackSeptum

Suture Ring

Suture Wings

Proximal Infusion Port

Medial Infusion Port

Medial Lumen

Distal Lumen

Introducer Valve

Sideport

AVA 3Xi DeviceTwice the convenience. A one-of-a-kind design.

32

AVA High-Flow DeviceAdvanced Venous Access

Increase Your Options

•Combine advantage of TRIPLE lumen infusion with sheath for catheter insertion.

•Employ only one insertion site which may reduce device complications and infections.

•Maximize flow rates with FLEXIBLE lumen walls.

•Increase flexibility for rapid response to patients requiring a second catheter insertion.


33

14 AVA High-Flow Device

Your patient’s needs may change by the minute, but their central venous access shouldn’t.

• The Advanced Venous Access (AVA) design integrates the capabilities of an introducer and multi-lumen central venous access into a single device.

• Insert an Edwards Swan-Ganz catheter when hemodynamic monitoring is required.

• Proprietary design includes flexible lumen walls that quickly adapt to fluid delivery needs.

• With AMC Thromboshield treatment, an antimicrobial* heparin coating.

AVA High-Flow Device Catalogue Sheath No. French Description PackNumber Length (cm) of Lumens Size Size

M3L9FHSI 11 3 9F AVA High-Flow Device with Heparin 5 and with injection caps*

AVA High-Flow Device - Accessories Catalogue Length (cm) Description PackNumber Size

MCT80L 80 AVA High Flow Catheter Contamination Shield 10

MO02F7P 2 AVA High Flow Short Obturator 10

MO13F7P 13 AVA High Flow Long Obturator 10




PROXIMAL115GA

PROXIMAL215GA

DIST AL 9F

Proximal 2 Lumen

Proximal 2 Infusion Port

Proximal 1 Infusion PortLumen ClampsSuture Wings

Suture Ring

Hemostasis Valve

Proximal 1 Lumen

Distal Lumen

AVA High-Flow DeviceAdvanced Venous Access

•Maximize flow rates with FLEXIBLE lumen walls.

•Increase flexibility for rapid response to patients requiring a second catheter insertion.

34


15 IntroFlex Percutaneous Sheath Introducer

IntroFlex introducers are the perfect companion for your Swan-Ganz catheters.

• Specifically designed to optimize insertion of Swan-Ganz catheters.

• Sheath material resists kinking and sheath collapse.

• Single-handed guidewire device allows for faster insertion.

• A grand range of insertion trays make the IntroFlex introducer a welcome addition to the critical care environment.

• Available with automatic (non-adjustable) and Tuohy Borst (adjustable) hemostasis valves that close when the Swan-Ganz catheter is pulled out to prevent blood leakage.

• Model numbers with an “H” contain Edwards AMC THROMBOSHIELD which is an antimicrobial heparin coating, that decreases viable microbe count on the surface of this product during handling and placement.

Tissue

Catheter

Sideport

SheathIntroducer Valve Housing

Distal Locking Adapter

Tuohy-Borst Proximal Adapter

Contamination Shield

Strain Relief



35

Accessories Catalogue Description PackNumber Size

GW3569I IntroFlex Guidewire – length 69cm 10

CC0280 Catheter Contamination Shield (Length 80cm) for IntroFlex Introducer 40 Automatic (Non-Adjustable) Valve Products

CC5280 Catheter Contamination Shield (Length 80cm) for IntroFlex Introducer 40 Tuohy Borst (Adjustable) Valve Products

IOBCAP Obturator with short Snap Lock Design for use with 6-9F Introducers 10

Automatic (Non-Adjustable) Hemostasis Valve Catalogue Size PackNumber Size

I301F6 6F 10

I301F7 7F 10

I301F8 8F 10

I300F85 8.5F 10

I301BF85H 8.5F 10

I305BF9 9F 10

Tuohy Borst (Adjustable) Hemostasis Valve Catalogue Size PackNumber Size

I451BF6 6F 10

I351BF7 7F 10

I451BF8 8F 10

I350BF85 8.5F 10

I351BF85H 8.5F 10

I355BF9 9F 10


36

Pressure Monitoring

1 Single TruWave Pressure Monitoring Sets

Catalogue Length Length Length Length Pack Specialties Number A (cm) B (cm) C (cm) D (cm) Size T001619A 30 - - - 20 -

T100202A 90 15 - - 20 -

T100209A 120 30 - - 20 -

T100214A 150 30 - - 20 -

T100215A 180 30 - - 20 -

T001631A 120 30 - - 20 -

T001645A 150 15 - - 20 Has second stopcock after the TruWave transducer

T005002A 150 30 - - 20 Has stopcocks on both sides of the TruWave transducer, loop system compatible

T001775A 180 15 - - 20 -

T433803A 180 30 180 - 20 Can switch between continuous arterial and venous pressure

T005052A 180 30 - - 20 Has second stopcock after the TruWave transducer

T005004A - - 120 30 20 Has stopcocks on both sides of the TruWave transducer, loop system compatible

150cm Clear

1 Single

37

Pressure Monitoring Pressure Monitoring

2 Double and Triple TruWave Pressure Monitoring Sets

2 Triple2 Double

Catalogue Length Length Length Length Length Length Pack Specialties Number A (cm) B (cm) C (cm) D (cm) E (cm) F (cm) Size T001702A 120 15 120 15 - - 10 -

T001650A 120 30 120 30 - - 10 -

T001658A 150 30 150 30 - - 10 -

T001786A 180 15 180 15 - - 10 -

T001712A 180 15 180 - - - 8 Third TruWave transducer can be attached

T001709A 180 30 180 30 - - 10 -

T001657A 180 30 180 30 - - 10 Third TruWave transducer can be attached, has second red stopcock after the TruWave transducer

T001713A 180 - 180 - - - 10 -

T001660A 120 30 120 30 120 30 8 -

T395606B 120 30 120 - 120 - 8 Has Swan-Ganz injectate housing

T493Y02B 180 15 150 - 150 - 10 -

38

Pressure Monitoring

3 TruWave Add-On Pressure Monitoring Sets

Catalogue Length Length Length Length Length Pack Specialties Number A (cm) B (cm) C (cm) D (cm) E (cm) Size

PX600F30 - - - - - 20 Standalone (30cc) transducer for use with mechanical infusion pump

PX600F - - - - - 20 Standalone 3cc transducer

PX600 - - - - - 20 Standalone transducer without snap-tab

T001789B 120 30 - 15 - 20 Has a stopcock before the TruWave transducer, loop system compatible

T001624A 150 - - - - 20 Has a stopcock before the TruWave transducer, loop system compatible

T005025A 150 30 - 15 - 20 Has a stopcock before the TruWave transducer, loop system compatible

PXMK1940 150 - - - - 10 -

T005005A 150 30 - 15 - 20 Has a stopcock before the TruWave transducer, loop system compatible

T001725A 120 30 - - - 20 -

T001797B 120 30 - 15 - 20 Has a stopcock before the TruWave transducer, loop system compatible

T001724A 180 30 - - - 20 -

Packaged without IV-tubing. With 3cc transducer unless indicated otherwise.

4 Standalone VAMP Adult Systems

Catalogue Length Length Length Length Total Pack Specialties Number A (cm) B (cm) C (cm) D (cm) Length Size 48VMP120 20 15 25 - 60 20 Arm mounted, 1 Sampling Site

48VMP160 125 15 25 - 165 20 Arm mounted, 1 Sampling Site



48VMP260 15 120 25 - 160 20 Pole mounted, 1 Sampling Site



Packaged without TruWave transducers and IV-tubing.

39

Pressure MonitoringPressure Monitoring

3 Add-On

4 VAMP Adult

40

Pressure Monitoring

5 VAMP Adult Blood Sampling SystemVenous Arterial blood Management Protection (VAMP) system is a needleless closed blood sampling system.

Triple TruWave/VAMP Adult Combo Sets Catalogue Length Length Length Length Length Length Length Length PackNumber A (cm) B (cm) C (cm) D (cm) E (cm) F (cm) G (cm) H (cm) Size

T005050B 150 15 25 30 150 30 150 30 8

T001746A 150 15 25 - 120 30 120 30 8

Single TruWave/VAMP Adult Combo Sets Catalogue Length Length Length Length Length Pack Specialties Number A (cm) B (cm) C (cm) D (cm) E (cm) Size

T100500A 20 15 25 - - 20 -

T001670A 125 15 25 - - 20 -

T001671A 150 15 25 - - 20 -

T001745A 150 15 25 - 150 20 Has second stopcock after the TruWave transducer

T005048B 150 15 25 30 - 20 -

T001744A 175 15 25 - - 20 -

Double TruWave/VAMP Adult Combo Sets Catalogue Length Length Length Length Length Pack Specialties Number A (cm) B (cm) C (cm) D (cm) E (cm) Size T001673A 125 15 25 120 30 10 -

T001741A 150 15 25 120 30 10 -

T434303A 175 15 25 180 30 10 -

VAMP Adult system

• The 5cc reservoir and shut-off valve provide safe and reliable sampling when proximal sampling is required.

• Self-sealing mechanism provides infection control and great convenience.

• Blunt, needleless cannula helps prevent accidental needle sticks for maximum safety.

• Needleless Z-site sampling port reduces blood buildup for collection of undiluted samples.

• Designed for use with all TruWave disposable pressure transducers.

• Comes in two variants; one to be mounted in a bracket on an IV pole and one to be mounted on a patient’s arm.

41


Single

Double

Triple

42

6 VAMP Plus Blood Sampling SystemVenous Arterial blood Management Protection (VAMP) Plus system allows the withdrawal of blood samples from pressure monitoring systems.

Triple TruWave/VAMP Plus Combo Sets Catalogue Length Length Length Length Length Length Length Length PackNumber A (cm) B (cm) C (cm) D (cm) E (cm) F (cm) G (cm) H (cm) Size T100671B 15 15 105 35 120 30 120 30 8

Standalone VAMP Plus Systems Catalogue Length Length Length Length Total Pack Specialties Number A (cm) B (cm) C (cm) D (cm) Length Size

VP1 15 15 140 - 170 10 Pole mounted, 1 Sampling Site

VP2 15 15 105 35 170 10 Pole mounted, 2 Sampling Sites

Single TruWave/VAMP Plus Combo Sets Catalogue Length Length Length Length Length Length Pack Specialties Number A (cm) B (cm) C (cm) D (cm) E (cm) F (cm) Size

T001691A 15 15 105 35 - - 8 -

T001765A 15 15 105 35 15 - 8 -

Double TruWave/VAMP Plus Combo Sets Catalogue Length Length Length Length Length Length Pack Specialties Number A (cm) B (cm) C (cm) D (cm) E (cm) F (cm) Size T430023B 15 15 160 25 150 30 10 -

T001760A 15 15 105 35 120 30 10 Second stopcock after both TruWave transducers

T001759A 15 15 105 35 120 30 8 Third TruWave transducer can be attached

T005074A 15 20 110 30 180 15 8 -

VAMP Plus system

• Large, 12cc reservoir is designed to conserve blood by eliminating the need to discard the clearing volume.

• Convenient, one-handed operation simplifies sampling and clearing volume reinfusion.• Audible, click-lock confirms that the reservoir is secure.• Choice of one or two Z-site sample ports provides sampling flexibility between

surgery and intensive care.• A variety of tubing lengths are available to meet most clinical needs.• Versatile reservoir design can be mounted on an IV pole next to a pressure transducer. • Integrated into disposable pressure transducer sets but also available individually.

Pressure Monitoring

43

Single Double

Triple Standalone


Pressure Monitoring

44

7 VAMP Flex Blood Sampling System

The VAMP Flex system builds upon the proven blood conservation and infection protection of the other VAMP systems, but now the 10cc reservoir is directly attached to the transducer for convenience. The VAMP Flex system is an excellent choice for providing clinician and patient safety in both the OR and ICU environments.

• Has two Z-site sampling ports to provide flexibility to sample either close to the patient or close to the pressure transducer, meeting the needs of clinicians in both OR and ICU.

• Self-sealing, Z-site sample ports reduce fluid path contamination common to stopcocks.

• Uniform sampling methodology ensures clinician accuracy and consistency.

• Blunt, needleless cannula helps prevent needlestick injuries for maximum safety.

Single TruWave/VAMP Flex Combo Sets Catalogue Length Length Length Length Length Pack Specialties Number A (cm) B (cm) C (cm) D (cm) E (cm) Size T005021A 80 70 30 - - 10 Second TruWave transducer can be attached (Loop System)

T005021G 30 120 30 - - 10 Second TruWave transducer can be attached (Loop System)

Double TruWave/VAMP Flex Combo Sets Catalogue Length Length Length Length Length Pack Specialties Number A (cm) B (cm) C (cm) D (cm) E (cm) Size T005089A 30 120 30 150 30 10 Third TruWave transducer can be attached (Loop System)

VAMP Flex system


45

Single

Double

Pressure Monitoring

46

8 VAMP Jr. Blood Sampling SystemThe VAMP Jr. system is designed to meet the volume-critical requirements of pediatric and neonatal patients.

Single Pediatric TruWave/VAMP Jr. Combo Sets Without IV-tubing. To be used with a mechanical infusion pump.

Catalogue Length Length Length Length Sampling Total Pack Specialties Number A (cm) B (cm) C (cm) D (cm) Sites Length Size VMP448PX 73 2 45 - 1 120 10 1.14mm inner Ø

VMP426PX 40 15 10 - 1 65 10 1.14mm inner Ø

Single Pediatric TruWave Pressure Monitoring Sets Without IV-tubing. To be used with a mechanical infusion pump.

Catalogue Length Length Length Length Total Pack Specialties Number A (cm) B (cm) C (cm) D (cm) Length Size

T432105A 120 15 - 90 135 20 1.14mm inner Ø

T001767A 120 30 - 150 150 20 1.14mm inner Ø with spike and drip chamber

Standalone VAMP Jr. Systems Come without TruWave transducers and IV-tubing.

Catalogue Length Length Length Length Sampling Total Pack Specialties Number A (cm) B (cm) C (cm) D (cm) Sites Length Size VMP306 8 + 2 2 3 - 2 15 20 1.14mm inner Ø

VMP406 8 4 5 - 1 15 20 1.14mm inner Ø

VMP426 40 15 10 - 1 65 20 1.14mm inner Ø

VAMP Jr. system

• Smaller (3cc) reservoir reduces patient blood loss and optimizes clearing volumes, while providing safe infu-sion and undiluted, accurate blood samples.

• Special hood helps reduce contamination risk.• Available in a variety of tubing lengths to accommodate

patient size requirements.


47

Standalone

Single

Combo Sets

Luer-activated sampling site

Pressure Monitoring

48

9 Luer-activated sampling siteLuer-activated sampling site (LASS) can be accessed with any luer-slip or luer-lock device, negating the need for a cannula.

Efficient Sampling and Pressure Monitoring • Allows priming/flushing in a closed system; no need

to flush the side port.• Side port can be closed to assure accurate pressure

monitoring without signal damping.• Enables in-line flushing with minimal internal volume

(0.25ml) after blood sampling.

TruWave/VAMP Plus Combo Sets

Catalogue Number

TruWaves Length A (cm)

Length B (cm)

Length C (cm)

Length D (cm)

Length E (cm)

Length F (cm)

Length G (cm)

Length H (cm)

Length I (cm)

Pack Size

T001691M 1 15 15 145 25 15 - - - - 10

T430023M 2 15 15 145 25 15 150 30 - - 10

T100671M 3 15 15 145 25 15 150 30 150 30 10

TruWave/VAMP Adult Combo Sets

Catalogue Number


Length B (cm)

Length C (cm)

Length D (cm)

Length E (cm)

Length F (cm)

Length G (cm)

Length H (cm)

Pack Size

T001744M 1 180 15 25 15 - - - - 20

T001741M 2 180 15 25 15 150 30 - - 10

T005050M 3 180 15 25 15 150 30 150 30 10

TruWave/VAMP Flex Combo Sets

Catalogue Number


Length B (cm)

Length C (cm)

Length D (cm)

Length E (cm)

Length F (cm)

Length G (cm)

Length H (cm)

Pack Size

T005021M 1 30 120 30 15 - - - - 10

T005089M 2 30 120 30 15 150 30 - - 10

T005091M 3 30 120 30 15 150 30 150 30 10


Catalogue Number


Length B (cm)

Length C (cm)

Length D (cm)

Length E (cm)

Pack Size

T470411M 1 8 3 3 3 15 20

Pediatric Truwave / VAMP Flex Combo Set without dripchamber

Catalogue Number


Length B (cm)

Length C (cm)

Pack Size

T311058M 1 150 30 15 10

49


49

TruWave/VAMP Plus Combo Sets

TruWave/VAMP Adult Combo Sets


50

Pediatric TruWave/VAMP Flex Combo Set

Pediatric TruWave/VAMP Jr Combo Set

Pressure Monitoring

51 51


10 VAMP Blood Sampling System – Accessories

11 TruWave Pressure Transducer – Accessories

TruClip holder

Catalogue Description Pack SizeNumber

VMP400 VAMP system needleless cannula 200

VMP700 VAMP system direct draw unit for direct line blood sampling 50

Catalogue Description Pack SizeNumber DTH1 TruWave Modular Backplate (each can hold 1 transducer/VAMP system) 20

DTH4 TruWave Backplate (holds up to 4 transducers and/or VAMP systems) 10

DTSC TruWave IV Pole Clamp for DTH1 and DTH4 Backplates 1

DTSS TruWave Velcro Arm Strap 10

TruClip Single-handed mounting - Holds up to 6 devices 1 (transducers/ VAMP/ FloTrac/ VolumeView)

VAMP System Needleless Cannula

TruClip holder - Easily attaches and adjusts with one hand

• Its intuitive design allows the TRUCLIP holder to be quickly and reliably attached to an IV pole or bed railing using just one hand.

52

Monitors & Accessories

1 EV1000 Clinical Platform

The EV1000 clinical platform from Edwards Lifesciences presents the physiologic status of the pa-tient in an intuitive and meaningful way. Designed in collaboration with and validated by clinicians, the EV1000 clinical platform offers you scalability and adaptability in both the OR and ICU.

The EV1000 clinical platform:

• Displays the parameters provided by the FloTrac sensor, the PreSep and PediaSat oximetry catheters, the VolumeView set and the ClearSight system.

• Utilises colour-based indicators which communicate patient status at a glance.

• Displays visual clinical support screens to allow for immediate recognition and increased understanding of rapidly changing clinical situations for improved decision enablement.

53

Continuous oximetry withPreSep or PediaSatcatheters

Fluid management with theFloTrac sensor

Volumetric insight with theVolumeView set

Fluid management with theClearSight system


MonitorThe EV1000 clinical platform offers you scalability and adaptability in both the OR and ICU. Experience the EV1000 clinical platform and the choice of the parameters you want, how you want to view them and bring clarity to every moment.

EV1000 DataboxThe EV1000 Databox is part of the EV1000A clinical platform, which mea-sures key hemodynamic parameters with FloTrac and VolumeView tech-niques, as well as oximetry saturation.

EV1000 Pump-UnitThe EV1000 Pump-Unit is part of the EV1000 Clinical Platform NI, which noninvasively measures blood pressure and key hemodynamic parameters. The Pump-Unit is one of the main units of the EV1000 Clinical Platform NI, providing air to the Pressure Controller.

Edwards Critical Care System

54


Visualised physiology in real time The EV1000 clinical platform’s intuitive interface pres-ents patient physiologic information clearly and simply. 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 for improved deci-sion enablement.

Perioperative optimizationMonitoring and optimizing Stroke Volume (SV) by vo-lume loading during the surgical procedure or in the immediate postoperative period is a key strategy for reducing postoperative complications. As an accurate marker of the position on the Frank-Starling curve, mechanically ventilated, induced SVV measured by the FloTrac system can be used to tailor fluid therapy. Car-diac output measured continuously by the FloTrac sys-tem can be used (in combination with SaO2 and hemo-globin) to monitor and optimize DO2 with fluid (including red blood cells) and inotropic agents. During surgery, as long as oxygen consumption is stable, ScvO2 can be used as a surrogate for DO2. The PreSep oximetry catheter provides continuous measurement of ScvO2. An ScvO2 value >73% can be targeted using fluid (in-cluding red blood cells) and inotropic agents.

Real patient positionon Frank-Starling curve

Flow of blood cells representsactual cardiac output

Heart size reflectspatient volumetric status

%Direction

of Change

Alarm & TargetRange

DynamicPatientStatus

Indicator

LargeValue

Display

Heart beats reflect current heart rate

Vasculature can depict vasoconstriction or vasodilation

5 levels of lung water shown in lungs

53-55

55

CatalogueNumber

Product Description

EV1000NI EV1000 Clinical Platform Noninvasive (Monitor, Pump Unit, Pressure Controller)

EVNIUPG EV1000 Clinical Platform Upgrade

EV1000A EV1000 Databox and Monitor

CatalogueNumber

Product Description

EV1000M EV1000 Clinical Platform Monitor

EVPMP EV1000NI Pump-unit

PC2K EV1000NI Pressure Controller kit

PC2B EV1000NI Pressure Controller Band Multi Pack

EVHRS EV1000NI Heart Reference Sensor

EVNIPCL3 EV1000NI Monitor Power Cable 3Ft

EVNIPCL12 EV1000NI Monitor Power Cable 12Ft

EVNIDBAC EV1000NI Databox Power Apaptor Cable

EVPMAC Patient Monitor Pressure Adaptor Cable

EVFTC1 FT/CVP Cable 1Ft

EVFTCL FT/CVP Cable 15Ft

EVVVTC1 VV Cable 7Ft

EVEC1 EV1000 Ethernet Cable 6Ft (DB-Monitor)

EVECL EV1000 Ethernet Cable 15Ft (DB-Monitor)

EVEC3FT EV1000 Ethernet Cable 3Ft (PU-Monitor)

EVEC12FT EV1000 Ethernet Cable 12Ft (PU-Monitor)

EVDTH4 Transducer Holder

PC2CCC EV1000 NI Pressure Controller Cuff Connector Cap

EVMB1 Monitor Bracket

EVPMPBRKT Pump Unit Bracket

EVBB1 Databox Mounting Bracket

EVPB1 Power Adaptor Bracket

EVRS Roll Stand

EVS1 Table Stand

EVNISWUPG EV1000 NI Panel Software Upgrade

EVPSB220 Power Supply 220V

EVPSB220L Power Supply 220V 15 Ft

EV1000 Clinical Platform - Accessories

EV1000 Clinical Platform - All Product Codes


56


2 Vigileo Monitor 27,28,30,51,52

The Vigileo monitor allows for the continuous monitoring of essential hemodynamic information, pro-viding rapid insight on a minimally invasive, easy-to-use platform. The Vigileo monitor may be used with the FloTrac sensor and PreSep and PediaSat oximetry catheters providing a single monitoring solution for advanced hemodynamic management.

• A single monitor solution for fluid optimization and tissue oxygenation.

• Simply requires patient age, gender, height and weight to initiate CCO monitoring.

• Provides immediate hemodynamic insight that may be missed using traditional vital signs alone 60.

• When used with the FloTrac sensor, the Vigileo monitor measures and displays key flow parameters such as CCO, SVV / SV, SVR.

• When used with the PreSep and PediaSat oximetry catheters, the Vigileo monitor measures and displays continuous ScvO2 (central venous oxygen saturation).

All Data Screen Derived Value Calculator Screen Tabular Trends Screen Graphical Trends Screen

57

Required Accessories CO / CI SV / SVI SVV ScvO2 SVR / SVRI

Edwards Approved Power Cord

APC09 (CCO Cable)

OM2E (ScvO2 optical module)

Central Venous Pressure slave cable

CatalogueNumber

Product Description Comments

MHM1E Vigileo Monitor

MHA-PLMNT

Vigileo Pole Mount Kit

VIG2S Roll Stand

APC09 Vigileo FloTrac CCO Cable

OM2E Edwards oximetry module (ScvO2)

MHAND Analog Slave Cable (Central Venous Pressure) From Datex AS/3 (44 pins)

MHANM1 Analog Slave Cable (Central Venous Pressure) From GE/Marquette Eagle, 3000, 7000 Series s/w 202 or 203 (20 pins)

MHANM3 Analog Slave Cable (Central Venous Pressure) From GE/Marquette RAC4/TRAM in slot 3 (12 pins)

MHANM4 Analog Slave Cable (Central Venous Pressure) From GE/Marquette RAC4/TRAM in slot 6 (12 pins)

MHANM5 Analog Slave Cable (Central Venous Pressure) From GE/Marquette RAC4/TRAM in slot 1-4 (15 pins)

MHANM6 Analog Slave Cable (Central Venous Pressure) From GE/Marquette RAC4/TRAM Module in slot 1-4/ 7000 BP

Module in position 6 (15 pins)

MHANM7 Analog Slave Cable (Central Venous Pressure) From GE/Marquette RAC4/TRAM Module in slot 1-4/ 7000 BPModule in position 6 (15 pins) - (Waveform B configuration)

MHANNK Analog Slave Cable (Central Venous Pressure) From Nihon Kohden BSM 8000 (37 pins)

Vigileo Monitor - All Product Codes


58

Complex cases require more than basic monitoring.

The Vigilance II monitor gives you the ability to present complex hemodynamic data in a simplified way to paint a clearer picture of the patient’s hemodynamic status.

• Continuous CO, SvO2, EDV, and other measured or derived parameters are presented on customized displays selected by the clinician.

• Onscreen, customized trend, data relationship, and STAT displays provide a complete picture of blood flow and tissue oxygenation for precision patient management.

• Interface with the bedside monitor for convenience and display of additional measured and derived parameters such as continuous SVR, DO2, DO2I, VO2, VO2I, and SaO2.

• The Vigilance II monitor is the ideal clinical tool for teaching the principles of advanced hemodynamic monitoring to clinical staff.

Four primary continuous display windows with cor-responding color-coded trend plot•Choose4of10available parameters•Scrollbackthrough historical data using time/date and event markers

Data relationship plot compares any 2 of 21 available parameters•Usethesplit-screen setting to show continuous data relationship in Frank-Starling curve format

Small, secondary continuous display window•Showupto8additional measured or derived parameters•Upto4datasetscanbe customized and selected for display on demand

Split-screen STAT box display window•Showsfasttrendestimates of CCO/CCI, EDV/EDVI

Catalogue Description Pack Number Size VIG2E Vigilance II Continuous Cardiac 1 Output Computer Includes: - Power Cord - Operator’s Manual

Simplify complex information using customized displays.


3 Vigilance II Monitor

59

Catalogue Description Pack Number Size VIG2E Vigilance II Continuous Cardiac 1 Output Computer Includes: - Power Cord - Operator’s Manual

Catalogue Product Description Pack SizeNumber 70CC2 Patient CCO Cable 1

OM2E Oximetry Optical Module for SvO2 Monitoring 1

VIG2S Roll Stand 1

VIG2AP Mounting Adaptor Plate 1

9850A Bath Temperature Probe 1

Accessories Required for Monitoring ParametersMonitored and Calculated Parameters

Required Accessory SvO2

Edwards Approved Power Cord

Edwards Patient CCO Cable

•

•••

•

•

CCO SVR ICO SV

Optical Module

ECG Cable

Analog Input Cable(s)

Injectate Temperature Probe

• • • • • • •

• • • • • •

CEDV REVF


Vigilance II Monitor - Accessories

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1. Bellamy MC.Wet, dry or something else? Br J Anaesth 2006; 97(6): 755-757.

2. Zheng H, et al.Goal-directed fluid therapy in gastrointestinal surgery in older coronary heart disease patients: randomized trial. World J Surg 2013; 37(12): 2820-2829.

3. van Beest PA, et al.The incidence of low venous oxygen saturation on admission to the intensive care unit: a multi-center observational study in The Netherlands. Crit Care 2008; 12(2): R33.

4. Perz S, et al.Low and “supranormal” central venous oxygen saturation and markers of tis-sue hypoxia in cardiac surgery patients: a prospective observational study. Intens Care Med 2011; 37: 52-59.

5. Reinhart K, et al.Continuous central venous and pulmonary artery oxygen saturation monito-ring in the critically ill. Intens Care Med 2004; 30(8): 1572-1578.

6. Rivers EP, et al.Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Crit Care 2001; 7(3): 204-211.

7. Ingelmo P, et al.Importance of monitoring in high risk surgical patients. Minerva Anestesiol 2002; 68(4): 226-230.

8. Scalea TM, et al.Central venous oxygen saturation: a useful clinical tool in trauma patients. J Trauma 1990; 30(12): 1539-1543.

9. Ander DS, et al.Undetected cardiogenic shock in patients with congestive heart failure pre-senting to the emergency department. Am J Cardiol 1998; 82(7): 888-891.

10. Eeftinck Schattenkerk D, et al.Nexfin noninvasive continuous blood pressure validated against Riva-Rocci/Korotkoff. Am J Hypertens 2009; 22(4): 378-383.

11. Martina JR, et al.Noninvasive continuous arterial blood pressure monitoring with Nexfin®. Anesthesiology 2012; 116(5): 1092-1103.

12. Wesseling KH, et al.Physiocal, calibrating finger vascular physiology for Finapres. Homeostasis 1995; 36: 67-82.

13. Kalmar AF, et al.Validation of Continuous Noninvasive Arterial Blood Pressure Measurements During General Anesthesia. Abstract presented at the Anesthesiology Annual Meeting, 2012.

14. Kalmar AF, et al.Technology report: ccNexfin monitor. Nederlands tijdschrift voor anesthesio-logie 2013; 26(3): 4-8.

15. Sterr J, et al.Comparison of the continuous noninvasive Nexfin monitoring system with conventional invasive methods to measure arterial blood pressure in high risk hip surgery, abstract presented at Euroanesthesia, 2013.

16. Broch O, et al.A comparison of the Nexfin® and transcardiopulmonary thermodilution to esti-mate cardiac output during coronary artery surgery. Anaesthesia 2012; 67(4): 377-383.

17. Chen G, et al.Comparison of noninvasive cardiac output measurements using the Nexfin mo-nitoring device and the esophageal Doppler. J Clin Anesth 2012; 24(4): 275-283.

18. Chen G, et al.Impact of non invasive and beat-to-beat arterial pressure monitoring on in-traoperative hemodynamic management. J Clin Monit Comput 2012; 26(2): 133-140.

19. Bubenek-Turconi SI, et al.Noninvasive continuous cardiac output by the Nexfin before and after pre-load-modifying maneuvers: a comparison with intermittent thermodilution cardiac output. Anesth Analg 2013; 117(2): 366-372.

REFERENCES

20. Truijen J, et al.Noninvasive continuous hemodynamic monitoring. J Clin Monit Comput 2012; 26: 267-278.

21. Hughson RL, et al.Cardiovascular regulation during long-duration spaceflights to the Internatio-nal Space Station. J Appl Physiol 2012; 112(5): 719-727.

22. Peñáz J.Photoelectric measurement of blood pressure, volume and flow in the finger. Digest of the 10th international conference on medical and biological enginee-ring - Dresden 1973; p. 104.

23. Peng K, et al. Goal-directed fluid therapy based on stroke volume variations improves fluid management and gastrointestinal perfusion in patients undergoing major or-thopedic surgery. Med Princ Pract 2014; 23: 413-420.

24. Maguire S, et al.Respiratory variation in pulse pressure and plethysmographic waveforms: in-traoperative applicability in a North American academic center. Anesth Analg 2011; 112: 94-96.

25. Michard F, et al. Rational fluid management: dissecting facts from fiction. Br J Anaesth 2012; 108(3): 369-371.

26. De Backer D, et al. Arterial pressure-based cardiac output monitoring: A multicenter validation of the third-generation software in septic patients. Intens Care Med 2011; 37: 233-240.

27. Biancofiore G, et al.Evaluation of a new software version of the FloTrac/Vigileo (version 3.02) and a comparison with previous data in cirrhotic patients undergoing liver transplant surgery. Anesth Analg 2011; 113: 515-522.

28. Manecke GR. Edwards FloTrac sensor and Vigileo monitor: easy, accurate, reliable cardiac output assessment using the arterial pulse wave. Expert Rev Med Devices 2005; 2(5): 523-527.

29. Manecke GR Jr, et al. Cardiac output determination from the arterial pressure wave: clinical testing of a novel algorithm that does not require calibration. Journal of Cardiothora-cic and Vascular Anesthesia 2007; 21(1): 3-7.

30. Walker R, et al. Vigileo™/FloTrac™ System: Stroke Volume Variation and hemodynamic trends are beneficial for acute care management of perioperative patients. The Internet Journal of Anesthesiology 2012; 30(2).

31. For educational materials to supplement this product visit www.Edwards.com/Education or contact your Edwards Lifesciences sales representative.

32. Edwards own elaborationBased on the ECCE Edwards Critical Care Education booklet: “Quick guide to Cardiopulmonary care”, 3rd Edition, 2014; p. 13-18. Ref: AR11206.

33. Ramsingh DS, et al. Outcome impact of goal directed fluid therapy during high risk abdominal sur-gery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput 2013; 27: 249-257.

34. Rivers EP, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001; 345(19): 1368-1377.

35. Colantonio L, et al. A randomized trial of goal directed vs standard fluid therapy in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. J Gastrointest Surg 2015; Jan 17 [Epub ahead of print].

36. Zaja J. Venous oximetry. Signa Vitae 2007; 2(1): 6-10.

37. Krahn G, et al. Continous central venous saturation during pericardial tamponade case re-port. Pediatr Crit Care Med 2007; 8(2): 18.2.153.

Helping to advance the care of the critically ill for 40 years, Edwards Lifesciences seeks to provide the valuable information you need, the moment you need it. Through continuing collaboration with you, ongoing education and our never-ending quest for advancement, our goal is to deliver clarity in every moment

For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/ECC bear the CE marking of conformity.

Edwards, Edwards Lifesciences, the stylized E logo, Advanced Venous Access, AMC Thromboshield, AVA 3Xi, CardioCath, CCOmbo, ccNexfin, Clarity in Every Moment, ClearSight, ControlCath, CO-Set+, Edwards Critical Care System, EV1000, FloTrac, Hi-Shore, IntroFlex, Nexfin, PediaSat, PreSep, Swan-Ganz, TruWave, VAMP, VAMP Flex, VAMP Jr, VAMP Plus, Vantex, Vigilance, Vigilance II, Vigileo, VIP, VIP+ and VolumeView are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

© 2015 Edwards Lifesciences Corporation. All rights reserved. E5400/02-15/CC

38. Krahn G, et al. Early clinical evaluation of the Edwards PediaSat™ oximetry catheter in pedia-tric patients. Pediatr Crit Care Med 2007; 8(3): 18.2.152.

39. Spenceley N, et al. Continuous central venous saturation monitoring in pediatrics: a case report. Pediatr Crit Care Med 2008; 9(2): e13-e16.

40. Mohseini-Bod H, et al. Evaluation of a new pediatric continuous oximetry catheter. Pediatr Crit Care Med 2011; 12(4): 437-441.

41. Edwards own elaborationBased on the ECCE Edwards Critical Care Education booklet: “Quick guide to Cardiopulmonary care”, 3rd Edition, 2014; p. 107-108. Ref: AR11206.

42. Donati A, et al.Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patitens. Chest 2007; 132: 1817-1824.

43. Monnet X, et al.Assessing pulmonary permeability by transpulmonary thermodilution allows differentiation of hydrostatic pulmonary edema from ALI/ARDS. Intens Care Med 2007; 33: 448-453.

44. Michard F, et al.Bedside assessment of extravascular lung water by dilution methods: Temp-tations and pitfalls. Crit Care Med 2007; 35(4): 1186-1192.

45. Kiefer N, et al.Clinical validation of a new thermodilution system for the assessment of car-diac output and volumetric parameters. Crit Care 2012; 16: R98.

46. Bendjelid K, et al.Validation of a new transpulmonary thermodilution system to assess global end-diastolic volume and extravascular lung water. Crit Care 2010; 14(6): R209.

47. Bendjelid K, et al.Performance of a new pulse contour method for continuous cardiac output monitoring: validation in critically ill patients. Gr J Anaesth 2013; 111(4): 573-579.

48. Campos MLM, et al.Techniques available for hemodynamic monitoring. Advantages and limita-tions. Med Intensiva 2012; 36(6): 434-444.

49. Zeng K, et al.The influence of goal-directed fluid therapy on the prognosis of elderly pa-tients with hypertension and gastric cancer surgery. Drug Des Devel and Ther 2014; 8: 2113-2119.

50. Scheeren TWL, et al.Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput 2013; 27: 225-233.

51. Scheeren TWL, et al.Performance of a minimally invasive cardiac output monitoring system (Flo-trac/Vigileo). Br J Anaesth 2008; 101: 279-280.

52. Cannesson M, et al.The ability of stoke volume variations obtained with Vigileo/FloTrac system to monitor fluid responsiveness in mechanically ventilated patients. Anesth Analg 2009; 108(2): 513-517.

53. Giglio MT, et al.Goal-directed hemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth 2009; 103: 637-646.

54. Benes J, et al.Intraoperative fluid optimization using stroke volume variation in high risk surgi-cal patients: results of prospective randomized study. Crit Care 2010; 14: 1–15.

55. van Beest PA, et al.Tissue oxygenation as a target for goal-directed therapy in high-risk surgery: a pilot study. BMC Anesthesiology 2014; 14: 122.

56. Garson L, et al.Implementation of a total joint replacement-focused perioperative surgical home: a management case report. Anesth Analg 2014; 118(5): 1081-1089.

57. Ghneim M, et al.Goal-directed fluid resuscitation decreases time for lactate clearance and facilitates early fascial closure in damage control surgery. Am J Surg 2013; 206(3): 995-1000.

58. Cecconi M, et al.Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care 2011; 15: R132.

59. Zhang J, et al.Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobec-tomy operations: a pilot study. Clinics 2013; 68(7): 1065-1070.

60. Le Manach Y, et al.Can changes in arterial pressure be used to detect changes in cardiac output during volume expansion in the perioperative period? Anesthesiology 2012; 117(6): 1165-1174.

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