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CARDIOHELP INTERFACE PRESENTER (CIP) USER GUIDE GENERAL INFORMATION ABOUT THE CIP:

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CARDIOHELP INTERFACE PRESENTER (CIP)

USER GUIDE

GENERAL INFORMATION ABOUT THE CIP:

• The CARDIOHELP Interface Presenter is a sales support tool. It gives sales staff the chance to get to

know the new CARDIOHELP software and, at the same time, offers the possibility of demonstrating the intuitive and user-friendly operating concept of the new CARDIOHELP software without taking the CARDIOHELP-i along. The CIP is not a simulation tool as it is not possible to manipulate values.

• The CARDIOHELP Interface Presenter is run in the browser of your computer/laptop. Versions for

Internet Explorer/Google Chrome and Mozilla Firefox/Safari are available to download. Please note that if you download the wrong version or if you use an old browser version, it might not be possible to run some features of the Presenter correctly.

• When the CIP files are downloaded a folder named “maquet-cip-fs” or “maquet-cip-ec” respectively will

be created. To run the CIP you have to unzip the files first. You need the content of the whole folder so keep all the files together. Don’t rename the files and folders as they are linked with each other.

• In addition to the browser versions, an iPad version is alsoavailable. Should you have any questions on

how to install the CIP on your iPad and the differing operating features of the iPad version, please consult the document “Installation Manual iPad”.

• The Presenter includes all the screens you need to present the software. However, it must be noted that

the CIP does not show all the functions of the new CARDIOHELP software 100% identically. For this

reason, we strongly recommend that you familiarize yourself with the program beforepresenting the CIP

for the first time.

• The original audio tones are included both when you start the CIP and in the integrated simulations.

Please remember to turn on the speakers on your machine when doing the presentation. For

information on how to play the audio tones in the iPad version, please read the document “Installation Manual iPad”.

• For the computer/laptop versions, we recommend “clicking through” the CIP once before holding your

first presentation for a customer. This saves the screens in the cache, accelerating the loading of the pages the next time they are opened.

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STARTING THE CIP:

• As the CIP is run in the browser, the standard browser controls are visible. To minimize these during the

presentation, press “F11”.

• Activating the power-on button starts up the CARDIOHELP-i. At this stage, the device performs a self

test. The status is displayed via the progress bar:

• Once the device has started, the thApp menu is shown. This does not correspond to what actually

happens on the CARDIOHELP-i. The device usually always starts in the last-used therapyapplication.

• The required application can be selected in the thApp menu. Realistic values are shown for every

application. These reflect a typical patient condition for the application in question. There are 5 applications available:

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Veno-arterial circulatory and pulmonary support (v-a ECLS) Ventricular support with a centrifugal pump (VAD)

Extracorporeal circulation for interventions lasting up to 6 hours employing systems with reduced foreign surfaces (MECC)

Veno-venous pulmonary support (v-v ECLS)

Extracorporeal CO2 elimination with low blood flow rates (PALP)

ADDITIONAL INFORMATION SCREEN

• In addition to reproduction of the original CARDIOHELP user interface, the CIP also features an

integrated screen with information about all aspects of CARDIOHELP. You can access this screen by clicking on the “thApp” icon in the top left corner of the respective screen:

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• Disposables & Accessories:

This section contains information on the sets that can be operated with the respective thApp in addition to images and videos on the topics of Catheters & Cannulae and Transport, as well as a picture of a fully equipped sprinter cart. When the fully equipped sprinter cart is opened, the individual components are named by means of mouse-over effects.

• CARDIOHELP Front Connectors:

Clicking on the Front Connector image enlarges it. Mouse-over effects are also integrated here to name the different connectors on the CARDIOHELP-i.

• Simulations:

This section can be used to directlyselect the simulations integrated in the CIP. Further information on

the topic of simulations can be found in the “Background Information on Simulations” section of this guide.

• Link to CARDIOHELP microsite:

To make it simple to access further information concerning CARDIOHELP, a direct link to the

CARDIOHELP microsite isintegrated in the CIP. This link is not enabled in the iPad version as the iPad

is not capable of displaying the microsite.

BACKGROUND INFORMATION ON SIMULATIONS:

There are eight simulations integrated in the CIP. These simulations show possible events that might arise when using the respective thApp. The simulations can be selected via the additional information screen or directly within the respective application:

Below you will find some background information on the individual simulations. This information can be used as a basis for what to say in your presentation:

Backflow Prevention, can be selected via:

Especially during the start phase or during the process of weaning a patient off extracorporeal support, a backflow may occur against the foreseen direction of flow due to the higher pressure in the arterial vascular system. This will be detected by the CARDIOHELP-i. A negative flow first triggers a low-priority alarm. After 6 seconds, the Backflow Prevention is initiated automatically. The CARDIOHELP-i will

select the necessary RPMautomatically to maintain the flow whilst stopped. A high-priority alarm will be

triggered simultaneously. This scenario is demonstrated in the simulation.

Additional information on “Backflow Prevention”: The user can cancel the Backflow Prevention by pressing the zero flow button and setting the required flow with the rotary knob. With the Backflow Prevention function we prevent an arteriovenous short circuit and thus guarantee an improved flow and pressure situation in the arterial vascular system.

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Battery supply, can be selected via:

When the mains current is interrupted, the internal batteries automatically assume the task of supplying the CARDIOHELP-i with power. The switching to battery operation is accompanied by a low-priority alarm in order to rule out accidental interruption of the mains current. The battery display (below right) flashes yellow and indicates the remaining battery life in hh:mm. Touching the field acknowledges the alarm and opens the battery menu. The user is then informed about the battery status and can return to the application after confirming via the confirm button.

Additional information on the battery supply: When the remaining battery life is down to 20%, a medium-priority alarm is triggered. This is confirmed in the same way. When the remaining battery life is down to 10%, a high-priority alarm is triggered. This alarm can only be stopped by restoring the mains power supply.

Emergency mode, can be selected via:

If the touchscreen fails (e.g., breakage) or the sensor bridge malfunctions, it might not be possible to control the CARDIOHELP-i and the perfusion system would have to be temporarily operated with the CARDIOHELP Emergency Drive. The Emergency Mode can be enabled to avoid manual operation. Pressing the illuminated Emergency Mode button disconnects the sensorbridge from the drive. All the

interventions are now turned off, the buttons on the CARDIOHELP-i have no function, and the RPMcan

be set with the rotary knob. The user can determine the current RPMsetting using the LED bar. Two

LEDs provide further information about the mains power supply and battery status. The Emergency Mode button is covered with a protective cap and is only activated after being held depressed for a

period of time. Theactivation is accompanied by two warning tones and a third longer tone announces

the start of the Emergency Mode. From now on, the user is informed via flashing of the Emergency Mode button and a reminder tone every minute that the device is running in Emergency Mode, as shown in the simulation.

Additional information on “Emergency Mode”: When in Emergency Mode, the CARDIOHELP-i can only be switched off by pressing the Emergency button until 9 short and one final longer tone are heard. • Bubble detected, can be selected via:

If a bubble is detected by the arterial flow/bubble sensor, the pump is stopped. This is accompanied by a high-priority alarm. Once the bubble has been removed, the arterial bubble sensor can be reset. The CARDIOHELP-i starts automatically with the last-set RPM flow rates.

The optional venous bubble sensor would also trigger immediate Backflow Prevention. • Zero flow, can be selected via:

This function is usually activated together with the safety button. In the simulation it is sufficient to press the zero flow button. The zero flow mode can be activated in veno-arterial perfusion during an

intervention to allow clamping of the aorta under low pressure conditions. In zero flow mode the

CARDIOHELP-i selects the RPMthat will stop the blood flow. This prevents arterio-venous backflow

through the perfusion system. When the zero flow button is pressed, the CARDIOHELP-i automatically

returns to the originally set RPMand flow rates.

pVen below alarm limit, can be selected via:

To prevent excessive suction in the venous section of the perfusion system or on the venous vascular wall, the user can set individual intervention limits. If anything changes concerning the volume status or an occlusion arises in the venous section of the perfusion system, CARDIOHELP-i reduces the RPM rate automatically and continues to run at the set pressure limit. This is accompanied by a medium-priority alarm. This avoids stopping perfusion completely, not to mention the associated disadvantages of stasis. In addition, if the user sets the warning limits close to the current pressure value, he can be informed early of any volume changes and implement appropriate countermeasures to avoid reducing the perfusion flow unnecessarily.

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• Global Override, can be selected via:

The Global Override can only be activated together with the safety button. It is generally used to avoid

interventions and acoustic alarms during the primingprocedure. It can also be used if it proves

necessary to switch off all of the interventions if the sensors should malfunction. The red coloring of the Global Override button and the reminder tone every 60 seconds alert the user to the fact that the Global Override mode is activated.

• System locked, can be selected via:

To avoid accidentally changing the set perfusion values, the interface in all thApps is automatically locked after 3 minutes. In addition, the user can lock the interface immediately by pressing the locking button. To unlock it, the user need only press the locking button for one second. If the locking button were to malfunction, it would no longer be possible to control the CARDIOHELP-i. To avoid this, a

back-up isincluded on the touchscreen making it possible to unlock the interface via two buttons. This

process is demonstrated in the simulation.

Additional information on “System locked”: The automatic lock of the control unit can only be deactivated in the thApp MECC in order to guarantee continuous unimpeded access to the perfusion values. The automatic lock is deactivated in the thApp MECC as standard when delivered.

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