CARDIOHELP BASIC TRAINING

NOTE:

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PRESENTATION OVERVIEW

Topic 2 – Areas of Application with CARDIOHELP

Topic 3 – Different Therapy Application with CARDIOHELP

Topic 4 – CARDIOHELP System Components

Topic 5 – Differences between CARDIOHELP and CARDIOHELP-i

Topic 6 – Modes of CARDIOHELP

Topic 7 – Disposable for CARDIOHELP

Topic 8 – HLS Set

Topic 9 – CARDIOHELP Sensors (Flow / Bubble / Level / Venous probe)

Topic 1 – CARDIOHELP Movie Presentation

CARDIOHELP VIDEO PRESENTATION

CARDIOHELP System is the world’s smallest portable heart-lung support system.

It is ideal for use in:

Intensive care units

cardiac catheter laboratory

operating room

trauma room

Furthermore, it is the perfect solution for safe and effective patient transport. There are, therefore, now new areas of use and treatment possibilities for extracorporeal circulation.

AREAS OF APPLICATION WITH CARDIOHELP

© MAQUET 6

Intensive care medicine:

CARDIOHELP System opens up new treatment options in intensivecare medicine which put far less stress on the patient and are alsocomparatively inexpensive. In cases of respiratory failure, the deviceprovides the oxygen supply.

Further areas of use include:

Acute respiratory distress syndrome (ARDS)

Septic shock

Pulmonary embolism

AREAS OF APPLICATION WITH CARDIOHELP

© MAQUET 7© MAQUET 7

Cardiology:

In the event of cardiogenic shock, a frequent consequenceof a heart attack, it is crucial to provide circulatory supportas quickly as possible. This must be guaranteed until thebody is able to resume this function itself. CARDIOHELPSystem can prevent organ damage resulting frominsufficient oxygen supply to the vital organs.

Areas of application include:

Cardiogenic shock

As stand-by or prophylactic support during high risk PCI

As a bridging system (bridge to recovery, bridge to bridge, bridge to decision, etc.), e. g., for myocarditis

AREAS OF APPLICATION WITH CARDIOHELP

© MAQUET 8© MAQUET 8

Cardiac surgery:

At the end of the 1990s, MAQUET developed the minimizedextracorporeal circulation system (MECC System). Its clinicaluse in the operating room led to new applications ofextracorporeal life support (ECLS) which required immediate orextended circulatory support. This principle has been perfectedwith CARDIOHELP System and the compact, integrateddesign of the HLS Modules. Thanks to the system’s mobility,patients can undergo further therapeutic measures (e. g.,intensive care) and diagnostic investigations (e. g., CT) duringextracorporeal life support.

The areas of use:

Pre-operative heart-lung support (e. g., cardiogenic shock)

Post-operative heart-lung support (e. g., low cardiac output syndrome)

As a bridging system (bridge to recovery, bridge to bridge, bridge to decision, etc.)

AREAS OF APPLICATION WITH CARDIOHELP

Emergency medicine:

CARDIOHELP Device weighs in at approx. 11 kg and caneasily be carried by one person and is sufficientlycompact to be used during transport. The system is usedin emergencies to restore and stabilize the atient’scardiopulmonary functions. It may have to be used duringcardiopulmonary resuscitation caused by, amongst others:

Anaphylactic shock

Intoxication

Hypothermia

AREAS OF APPLICATION WITH CARDIOHELP

The individual operating modes and the disposables make the CARDIOHELP life support system suitable for

all indications where cardiac and/or respiratory support is needed. Thus, the principle of ECLS for supplying

the heart and/or lungs with oxygen is now available in new areas as a means of life support and to save lives.

During open heart surgery, for example minimal extracorporeal circulation (MECC) with the CARDIOHELP life

support system, ECLS is less stressful for the patient than the use of a conventional heart-lung machine. In

cases of respiratory failure without cardiac impairment CARDIOHELP provides respiratory assistance with

veno-venous ECLS. During veno-arterial ECLS the life support system provides cardiopulmonary support. In

cases of severe respiratory failure CARDIOHELP can also be used for pump assisted lung protection (PALP)

with extracorporeal CO2 removal to enable protective ventilation.

DIFFERENT THERAPY APPLICATIONS

WITH CARDIOHELP

Veno-venous ECLSRespiratory assistance for lung disorders:

This form of ECLS is mostly used when the heart is still able to pump blood through the circulatory system without any

additional support, as in the case of acute respiratory failure or a massive pulmonary embolism. The blood is removed

from the jugular vein or a femoral vein for enrichment with oxygen, after which it is returned to a vein.

Place of use: ICU

Fields of applications:

Respiratory failure without cardiac impairment:

ARDS

Septic shock

Bridge to lung transplant

Customer and Patient value:

Little complexity, safe to use and more security due to little to no change of components during entire system run.

Special feature: Enables CO2 removal and oxygenation for up to 30 days.

Access to Patient: percutaneous cannulation of jugular and femoral veins

DIFFERENT THERAPY APPLICATIONS

WITH CARDIOHELP

Veno-arterial ECLS Cardiac and respiratory support:

Veno-arterial ECLS is used with patients whose hearts are not adequately supporting the circulation, or have stopped.

This occurs with a myocardial infarction (heart attack). It is vitally important to ensure cardiopulmonary support as early

as possible to prevent organ damage. Furthermore, the CARDIOHELP life support system can increase the patient’s

chances of survival by enabling examination in the cardiac catheter laboratory and revascularization by means of

catheters or cardiac surgery.

Place of use: ICU, Cath. Lab, ER, OR

Fields of application: respiratory and circulatory failure:

Cardiogenic shock

During cardiopulmonary resuscitation

As preventive left ventricular support in the event of low cardiac output During PTCA

In cases of acute cardiac arrest or severe cardiogenic shock during the intervention

As standby during high-risk PTCA

In cases of acute post-infarction VSD

Customer and patient value:

One system fits all, from a fast deployable emergency life saving circulatory support system

to a long term VAD with oxygenation possibility.

Special feature: for a cardiac support and respiratory assistance up to 30 days

Access to patient: percutaneous cannulation of the femoral vein and femoral or subclavian artery

DIFFERENT THERAPY APPLICATIONS

WITH CARDIOHELP

CO2 Removal Pump Assisted Lung Protection (PALP)

In severe cases of respiratory failure the CARDIOHELP life support system can be used in combination with

protective ventilation for pump assisted lung protection (PALP) to reduce the CO2 level in the blood. In these cases,

protective ventilation focuses on 6 ml/kg (instead of 12 ml/kg BW) tidal volume within the limits of a certain airway

pressure and respiratory rate. These ventilation limits cause higher CO2 levels than normal, which is acceptable in

many situations(concept of permissive hypercapnia). However, in some cases complications due to high CO2 levels

(acidosis, pulmonary hypertension) occur and some patients need low to normal CO2 levels to protect the brain.

Places of use: ICU

Fields of applications:

Severe respiratory failure, e.g. ARDS;

Severe COPD (chronic obstructive pulmonary disease)

Customer and patient value: extracorporeal CO2 removal enables protective ventilation to be used

Special feature: allows CO2 removal for up to 30 days of ECLS

Access to patient: percutaneous cannulation of either jugular or subclavian and femoral veins

DIFFERENT THERAPY APPLICATIONS

WITH CARDIOHELP

RevascularizationMinimized Extracorporeal Circulation for cardiac surgery (MECC)

Minimal extracorporeal circulation (MECC) with the CARDIOHELP life support system makes ECLS for

cardiopulmonary support during open heart surgery less stressful for the patient than when a conventional heart-lung

machine is used. With the compact, integral design of the QUADROX-iR oxygenator-pump module, the priming volume

and blood surface contact are kept as small as possible. Combined with the exceptionally small pressure drop plus the

BIOLINE Coating of the disposable, trauma is minimized.

Moreover, the CARDIOHELP life support system is an intuitively operated system, which is ready for use in minutes for

emergency situations. Thanks to the system’s mobility, the patient can undergo further therapeutic measures and

diagnostic investigations during ongoing circulatory support.

Place of use: OR

Procedure: minimally-invasive perfusion system with full support for heart and gas exchange for up to 6 h

Fields of application:

On-pump CABG surgery.

Postoperative "low cardiac output" syndrome

Patient transport from and into the cardiac operating room, from the emergency/trauma room,

from and into the catheterization laboratory

Customer and Patient Value: minimally invasive, less blood product use¹, shorter stay in ICU²

Special feature: no blood to air contact, minimal hemodilution

Access to Patient: surgical cannulation of right atrium and aorta

DIFFERENT THERAPY APPLICATIONS

WITH CARDIOHELP

CARDIOHELP SYSTEM COMPONENTS

CARDIOHELP SYSTEM COMPONENTS

CARDIOHELP CARDIOHELP-i

QUADROX-iR adult QUADROX-iR small adult

HLS Set Advanced 7.0

HLS Set 7.0

HLS Set Advanced 5.0

HLS Set 5.0

DIFFERENCES BETWEEN

CARDIOHELP AND CARDIOHELP-i

No venous probe available

No internal sensors from disposable available

Internal sensors from disposable available

Venous probe available

Differences Hardware

CARDIOHELP-i

Depending on the CARDIOHELP version, different applications are available. Essentially, they differ in the information

displayed and available functions .The user is only provided with the functions needed for his/her area of work, thus

keeping the system clear, simple and quick to operate.

OR application (“Operation Room”): designed for use in the operating room

ICU application (“Intensive Care Unit”): designed for use in the intensive care unit (only CARDIOHELP-i)

TM application (“Transport Mode”): designed for interhospital patient transport (only CARDIOHELP-i)

If more than one application is available, you can switch between the applications The OR, ICU and TM applications are

designed and optimized for the environments mentioned above. Nevertheless, the intended use of the applications is not

limited to the specific environment. Within the intended environment of the CARDIOHELP System, you can use any

available application that is suitable and safe for the patient and the current situation

CARDIOHELP

Differences Hardware

DIFFERENCES BETWEEN

CARDIOHELP AND CARDIOHELP-i

Differences Overview

CARDIOHELP CARDIOHELP-i

Support of disposable´s sensors --- YES

Applications OR OR, ICU, TM

“Blood parameters” screen --- YES

Offline recording --- YES

Monitor blood parameters

SVO2, Hb, Hct--- YES

Flow/bubble sensor YES YES

Venous probe

with connection cable--- YES

Disposable connection cable --- YES

USB Stick --- YES

DIFFERENCES BETWEEN

CARDIOHELP AND CARDIOHELP-i

User interface – Differences between software applications : STARTUP SCREEN

OR software application ICU software application TM software application

Alarm delay button

only in ICU application available !

DIFFERENCES BETWEEN

CARDIOHELP AND CARDIOHELP-i

MODES OF CARDIOHELP

RPM and LPM MODES

The CARDIOHELP can be operated in LPM or RPM mode:

RPM mode (speed control, “revolutions per minute”)

In RPM mode, you can set the pump’s setpoint speed. The CARDIOHELP operates the pump constantly at the set speed. This enables the flow to be varied, according to the resistance of the extracorporeal circulation.

LPM mode (flow control, “liters per minute”)

In LPM mode, you can set the setpoint flow. The CARDIOHELP operates the pump in such a way that the set flow is maintained. This enables the speed to be varied, according to the resistance of the extracorporeal circulation.

To activate the “Global Override” mode, hold down the “safety” button and press the “Global Override”

Symbol . . The color of symbol changes .

In the zero flow mode, the CARDIOHELP aims at a flow of 0 l/min by controlling the pump accordingly. In this way,

a backflow can be prevented.

The zero flow mode can be activated manually or is activated automatically by backflow prevention.

To activate the zero flow mode, hold down the “safety” button and press the “Zero flow mode” button .

MODES OF CARDIOHELP

Zero flow MODE

Backflow Prevention

The backflow prevention can detect and react to a backflow of blood. For this, the CARDIOHELP

monitors the blood flow, displays any necessary alarms and activates the zero flow mode automatically,

to prevent any backflow.

Global Overwrite MODE

In “Global Override” mode, all interventions, acoustic alarms and backflow prevention are disabled.

HLS Module Advanced, the disposable:

The core of the complete HLS Set integrates not only a cutting-

edge VAD centrifugal pump and a special gas exchanger, but also

sensors for three pressure parameters and arterial temperature.

Equipped with a high-quality diffusion membrane with a

biocompatible, blood-friendly BIOLINE Coating, the module can

be used for up to 30 days of continuous function. This is the

world’s first disposable combination of VAD and gas exchanger

incorporating a high-tech sensor for measuring venous oxygen

saturation, hematocrit, hemoglobin and venous temperature.

DISPOSABLE FOR CARDIOHELP

Integrated gas exchanger with diffusion membrane

Integrated heat exchanger

Integrated cutting edge VAD centrifugal pump

Approval for 30 days and transportation approval

BIOLINE Coating

HLS Module Advanced 7.0:

Unprecedented integrated sensors for:

Venous pressure (Pven),

Internal pressure (Pint),

Arterial pressure (Part),

Arterial temperature (Tart)

Integrated cell to connect venous probe to measure:

Venous oxygen saturation

Hemoglobin / Hematocrit

Venous temperature (Tven)

HLS Module Advanced 7.0:

DISPOSABLE FOR CARDIOHELP

DISPOSABLE FOR CARDIOHELPHOW DOES IT WORK?

Gas (O2)

Water from

heater cooler unit

Blood from patient

(Low in oxygen)

Blood to patient

(Rich in oxygen )

Blood goes through

centrifugal pump into

the membrane of

oxygenator.

Venous blood flows via

gravity to the pump

Step 1:

Step 2:

Step 3:

In the membrane venous blood will enriched with

oxygen and will cool down or heated up by the water.

Blood flows around the hollow fibers.

Water and gas flows through the hollow

fibers.

HLS Module Advanced 7.0:

Integrated VAD pump on the blood inlet side of the gas-exchanger

[1] Gas inlet

[2] De-airing membrane

[3] Centrifugal pump

[4] Water connectors

[5] Venous cell

[6] Connection for internal sensors

[7] Quick de-airing

2

7

6

5

4

3

1

DISPOSABLE FOR CARDIOHELP

HLS Module Advanced 7.0:

Integrated VAD pump on the blood inlet side of the gas-exchanger

[1] Blood inlet

[2] Blood outlet

[3] Temperature sensor

[4] Gas outlet

1

2

3

4

DISPOSABLE FOR CARDIOHELP

OVERVIEWDISPOSABLE TYPES FOR CARDIOHELP

Name QUADROX-iR HLS Module HLS Module Advanced

Picture

5 Liter/min Version YES (QUADROX-iR small adult) YES (HLS Module 5.0) YES (HLS Module Advanced 5.0)

7 Liter/min Version YES (QUADROX-iR adult) YES (HLS Module 7.0) YES (HLS Module Advanced 7.0)

BIOLINE COATING YES YES YES (HIT Set with

SOFTLINE COATING available*)

Internal temperature

sensorsNO

YES (1x Arterial Infrared Sensor)

YES(1x Arterial Infrared Sensor)

Internal pressure

sensorsNO

YES

(pInt / pVen / pArt)

YES

(pInt / pVen / pArt)

Venous probe

connectionNO NO YES

Approval(s) 6 hours 30 days 30 days / transport

(* HIT Set with 6 hour approval)

HLS SET FOR CARDIOHELP

HLS SET

CARDIOHELP FLOW/BUBBLE SENSOR

Flow and bubble monitoring :

The flow of blood is measured by a flow/bubble sensor.

This means, in one housing we have a combined

measuring tool for the flow and a sensor to detect air

bubbles. A detected air bubble stops immediately the

centrifugal pump (called intervention) to prevent an air

embolism. The sensor have to be fitted so that the

blood flows in the direction of the arrow on the cover.

NOTE:

Only 3/8” x 3/32” PVC tubes approved for this system.

[1] Cover with flow indicator

[2] Connection cable to CARDIOHELP

[3] Tube retainer

[4] Locking mechanism

Rx Tx

reflector

Flow

Tx

reflector

Flow

Rx

Measurement against flow t2 Measurement flow direction t1 = ∆t flow

reflector reflector

ULTRASONIC FLOWMETER BASICS

Hose wall

The transit-time method

The transit-time method exploits the fact that the propagation rate of an

ultrasonic signal depends on the flow rate of the carrier medium. Like a swimmer

swimming against the current, the ultrasonic signal moves more slowly against

the flow direction than in the flow direction of the medium. The transit time of the

sonic signals which flow through the medium in flow direction is shorter than the

transit time of the sonic signals which flow through it against flow direction. By

measuring the difference in flow rate Δt, it is possible to calculate the mean flow

rate on the path taken by the ultrasonic impulse.

This process involves transmitting one ultrasonic impulse in flow direction and a second impulse in the opposite

direction through the medium. The sensors work alternately as transmitters (Tx) and receivers (Rx).

Since ultrasonic waves also penetrate solid objects, the sensors can be attached to the outer wall of the hose.

Therefore measuring is not invasive and inserting the sensors does not require any intrusion into the system.

Capacitive level sensor monitoring :

The blood level in the reservoir is measured by a

capacitive level sensor.

The level pad will be attached to the lowest level limit of

reservoir. If the liquid´s surface falls below this limit, the

CARDIOHELP gives an optical and an acoustical alarm

and stops the pump.

The level pad must be attached with the double-faced

Scotch® tape horizontally to the desired position on the

blood reservoir.

NOTE:

Sensor pad must be replaced after every perfusion.

LEVEL SENSOR

1

2

[1] Level pad (disposable)

[2] Level Sensor

Distance holder

Capacitive level sensor monitoring :

Front side:

At the front side of level pad are a lot of distance holder

mounted to avoid influences from front side.

The detecting area of the sensor pad is same as the

height of the pad self.

Back side:

Behind the double-faced Scotch® tape the sensor

surface area is located. This sensor surface area is

made of a thin aluminium foil.

J

Dete

ctin

gare

a

LEVEL SENSOR

VENOUS PROBE

Blood parameter measurement:

The venous probe of the CARDIOHELP-i measures

the venous blood parameters:

SVO2 Oxygen saturation

Hb Hemoglobin

Hct Hematrocrit

TVen Venous blood temperature[1] LEDs

[2] Optical sensors

[3] Infrared temperature sensor

1

2 3

VENOUS PROBE

Blood measurement Principe:

The probe has three LEDs which irradiate the blood

through the BMU Cell at different wavelengths. An

optical sensor measures Hb and Hct concentration

without contact. A second optical sensor measures the

SvO2 value in the same way.

The temperature TVen is measured by a non-invasive,

thermopile infrared sensor.

Probe fixation:

For measurement, the probe is connected to the

disposable´s measuring cell.

When the probe is not in use, it is hooked into the

holder on the safety bar to protect the sensors.

THANK YOU!

MAQUET Cardiopulmonary AG

Hechinger Strasse 38

D-72145 Hirrlingen, Germany

Phone: +49 (0) 7478 921-414

Your support contact:

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