CARDIOHELP BASIC TRAINING

NOTE:

The hole presentation can be downloaded as a PDF-document with the button

.

This button is located at the right upper corner of the window.

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)

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.

© MAQUET 6

Intensive care medicine:

CARDIOHELP System opens up new treatment options in intensive

care medicine which put far less stress on the patient and are also

comparatively inexpensive. In cases of respiratory failure, the device

provides the oxygen supply.

Further areas of use include:



Acute respiratory distress syndrome (ARDS)



Septic shock

© MAQUET 7

© MAQUET 7

Cardiology:

In the event of cardiogenic shock, a frequent consequence

of a heart attack, it is crucial to provide circulatory support

as quickly as possible. This must be guaranteed until the

body is able to resume this function itself. CARDIOHELP

System

can

prevent

organ

damage

resulting

from

insufficient 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

© MAQUET 8

© MAQUET 8

Cardiac surgery:

At the end of the 1990s, MAQUET developed the minimized

extracorporeal circulation system (MECC System). Its clinical

use in the operating room led to new applications of

extracorporeal life support (ECLS) which required immediate or

extended circulatory support. This principle has been perfected

with CARDIOHELP System and the compact, integrated

design 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) during

extracorporeal 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)

Emergency medicine:

CARDIOHELP Device weighs in at approx. 11 kg and can

easily be carried by one person and is sufficiently

compact to be used during transport. The system is used

in emergencies to restore and stabilize the

atient’s

cardiopulmonary functions. It may have to be used during

cardiopulmonary resuscitation caused by, amongst others:



Anaphylactic shock



Intoxication



Hypothermia

The individual operating modes and the disposables make theCARDIOHELP life support systemsuitable 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 extracorporealCO₂removalto enable protective ventilation.

Veno-venous ECLS

Respiratory assistance for lung disorders:

This form of ECLSis 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 CO₂removal 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 thepatient’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

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

Revascularization

Minimized 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

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.

ORapplication (“Operation Room”): designed for use in the operating room

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

TMapplication (“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

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

S

O

, Hb, Hct

---

YES

Flow/bubble sensor

YES

YES

Venous probe

with connection cable

---

YES

Disposable connection cable

---

YES

USB Stick

---

YES

DIFFERENCES BETWEEN

User interface – Differences between software applications :

STARTUP SCREEN

ORsoftware application ICUsoftware application TMsoftware application

Alarm delay button

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 .

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

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



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

DISPOSABLE FOR CARDIOHELP

HOW 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.

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

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

DISPOSABLE FOR CARDIOHELP

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

sensors NO

YES

(1x Arterial Infrared Sensor)

YES

(1x Arterial Infrared Sensor)

Internal pressure

sensors NO

YES (p_Int / p_Ven/ p_Art)

YES (p_Int/ p_Ven/ p_Art) Venous probe

connection NO NO YES

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

HLS SET FOR CARDIOHELP

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

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.

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.

1

2

[1]

Level pad (disposable)

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

LEVEL SENSOR

Blood parameter measurement:

The venous probe of the CARDIOHELP-i measures

the venous blood parameters:



S

O



Oxygen saturation



Hb



Hemoglobin



Hct



Hematrocrit



T



Venous blood temperature

[1]

LEDs

[2]

Optical sensors

[3]

Infrared temperature sensor

1

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 T

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.

Hechinger Strasse 38

D-72145 Hirrlingen, Germany

Phone: +49 (0) 7478 921-414