Page 1 ® EXCOR Ventricular Assist Device ® EXCOR Active driving system Instructions for Clinical Use Edition 4.0 EXCOR Adult EXCOR Pediatric ® ®...
Page 2 1015002x03...
Page 3 Component Label on the component Driving unit (for model-dependent scope of functionality, see Tab. 3-2 , page 22) Depending on approval region; not all models available. Ask Berlin heart or your distributor about model availability Driving unit 1502200 Driving unit...
Page 4 These instructions for use may not be reproduced, forwarded, transmitted by electronic media, stored in a data processing system, or translated into another language, either wholly or in part, without the written consent of Berlin Heart GmbH. These instructions for use are intended for information purposes only. The contents of the instructions for use may be supplemented, modified or updated at any time without prior notice.
Page 5: Table Of Contents
2.5.1 Safety Symbols ......................17 2.5.2 Symbols........................18 General Information EXCOR Active System Overview – Driving Unit with EXCOR VAD ............21 Components and Locations of Use .................. 22 Scope of Driving Unit Functionality................... 22 Intended Use ........................23 3.4.1 Use ..........................
Page 6 Table of contents 5.2.2.7 Connecting the Adapter for External Alarm............46 5.2.3 The Flow Sensor ......................47 5.2.3.1 Setup ........................47 5.2.3.2 Measurement Precision and Alarms ..............50 5.2.3.3 Attaching Flow Sensors to Cannulae and Blood Pumps........50 5.2.3.4 Removing the Flow Sensor from the Cannula............51 5.2.3.5 Replacing the Sensor Quick Connect ..............
Page 7 Table of contents Connecting the Panel PC to a Driving Unit............... 79 6.7.1 Connection via USB ....................79 User Interface General..........................81 7.1.1 File and Menu Bar ....................... 82 7.1.2 Status Bar........................83 7.1.3 Buttons ........................84 Functions of the Menu Bar ....................85 7.2.1 User Login ........................
Page 8 Table of contents 8.6.1 De-Airing the Blood Pump ..................117 8.6.2 LVAD and RVAD ....................... 117 8.6.3 BVAD......................... 118 8.6.4 Setting Rate and Synchronization ................119 8.6.5 Optimizing the Filling and Emptying of the Blood Pumps.......... 119 8.6.5.1 Blood Pump Phases..................... 120 8.6.5.2 Basic Procedure ....................
Page 9 Table of contents Performing Trainings 11.1 Target Group for Trainings ..................... 147 11.1.1 Qualified Medical Personnel..................147 11.1.2 Lay Users ......................... 147 11.2 Safety Information ......................147 11.3 Training Content Checklists.................... 148 11.3.1 Operating Components ..................... 148 11.3.2 Behavior and Safety ....................149 11.4 Training Protocols......................
Page 10 User Interface Too Dark or Not Reacting ............... 194 Maintenance, Cleaning and Disinfection 18.1 Safety Information ......................195 18.2 Maintenance ........................195 18.2.1 Maintenance Personnel..................... 195 18.2.2 Maintenance by Berlin Heart / Distributor..............195 18.2.2.1 Intervals........................ 195 18.2.3 Inspections by the Operator ..................196 18.2.3.1 Intervals........................ 196 1015002x03...
Page 11 Table of contents 18.2.3.2 Panel PC ......................196 18.2.3.3 Power Supply Units ....................197 18.2.3.4 Docking Station ....................197 18.2.3.5 Battery Charging Unit ................... 197 18.2.3.6 Stroller Board ....................... 197 18.3 Cleaning and Disinfection....................197 18.3.1 General Rules ......................198 18.3.2 Cleaning Agents and Disinfectants, Resources ............
Page 12 Table of contents 1015002x03...
Page 13: Contact
Contact Hotline +49 (0)30 81 87 27 72 Medical and technical assistance for 24 hours a day, every day medical personnel Manufacturer Berlin Heart GmbH Telephone: +49 (0)30 8187 2600 Wiesenweg 10 Mon–Fri 8:00 am–6:00 pm 12247 Berlin Germany Fax: +49 (0)30 8187 2601 www.berlinheart.de...
Page 14 Contact 1015002x03...
Page 15: Introduction
Active system. EXCOR Active can be used as a mobile driving system of the EXCOR VAD ventricular assist device. The correct use of the sterile components of the EXCOR VAD system is described in the “EXCOR VAD Sterile Components” in- structions for use.
Page 16: Explanation Of Key Terms
EXCOR Ikus Stationary driving system for the EXCOR VAD (hereinafter referred to as Ikus) Driving unit Driving system for EXCOR VAD – EXCOR Active or Ikus, depending on context (usually EXCOR Active in these instructions for use) Replacement driving unit EXCOR Active driving unit configured with the cur- rent settings for the BVAD patient.
Page 17: Meaning Of Text Markups
Introduction Meaning of Text Markups Instructions: Read the instructions completely. Carry out steps as instructed. Explanations of emphases Formatting Meaning Parameter Denotes a parameter (except in headers or directories) Denotes a menu or a button on the user interface Denotes a button <Button>...
Page 18: Symbols
Introduction 2.5.2 Symbols Electrical or electronic device; Article number do not dispose with household waste. Only use and store in a dry Lot number environment. Defibrillation-proof applied M-ID part, type CF (cardiac floating type) Manufacturer Distribution partner Date of manufacture Use by Temperature threshold, lower temperature threshold dis-...
Page 19 Introduction The FCC label certifies that device electromagnetic inter- ference is below the threshold Energy efficiency level values permitted by the Fed- eral Communications Commis- sion. Specifies the environment friendly use period (EFUP) for the device. The number 10 refers to the number of years Notice within which it is unlikely that the device will leak or have...
Page 20 Introduction 1015002x03...
Page 21: General Information Excor Active
4 Driving tubes and sensor cables, connected 2 Flow sensors to the cable wrap 3 Blood pumps 5 EXCOR Active driving unit 6 Caddy Fig. 3-1 EXCOR VAD cannulae and blood pumps on the EXCOR Active driving system – BVAD 1015002x03...
Page 22: Components And Locations Of Use
General Information EXCOR Active Components and Locations of Use Mobile components for use in hospi- Stationary components for use in tals and healthcare environments, hospitals, suitable for indoor use suitable for indoor and outdoor use Driving unit Battery charging unit Flow sensor with cable wrap Power supply unit for driving unit and battery charging unit...
Page 23: Intended Use
General Information EXCOR Active Intended Use 3.4.1 The EXCOR VAD is an extracorporeal ventricular assist device used for support of the left ventricle, the right ventricle, or both. The EXCOR Active system is an electro-pneumatic driving system for the EXCOR VAD ventricular assist device.
Page 24: Clinical Benefits
General Information EXCOR Active Intended conditions and environments of use The EXCOR VAD and EXCOR Active are suitable for use in indoor and outdoor areas in professional healthcare facilities. The device may be operated on mains power or using the batteries included. The sys- tem can switch between power sources with no interruption of operation.
Page 25: Combination With Other Products And Procedures
Combination with Other Products and Procedures Permitted combinations Only operate the EXCOR Active system with EXCOR VAD components. Take all in- dications, contraindications, and instructions for use into account. An overview of the blood pumps and cannulae to be used, as well as information on their possible com- binations, can be found in the “EXCOR Sterile Components”...
Page 26: Disposal Of Components
General Information EXCOR Active for use can be requested from the manufacturer. You can also download the instruc- tions for use from the manufacturer’s website. See Chapter 1: Contact, page 13. Disposal of Components General Electronic components may be returned to the manufacturer for professional disposal. Appropriate disposal of all other components is the responsibility of the operator.
Page 27 General Information EXCOR Active Component Product life in years USB cable USB stick Tab. 3-3 Product life – Components Reaching the specified product life depends on adherence to the specified inspection and maintenance intervals and use of the product as intended. For more information, see Chapter 18: Maintenance, Cleaning and Disinfection, page 195.
Page 28 General Information EXCOR Active 1015002x03...
Page 29: Safety Information
Do not make any changes to components. Do not open or disassemble any components! Only use EXCOR Active together with components of the EXCOR VAD system. Components from other manufacturers may only be used to- gether with the EXCOR Active if they are specified in the instructions for use, and if the components are delivered by Berlin Heart.
Page 30: Caregivers
Safety Information Have an EXCOR Active driving unit or an Ikus on hand in the hospital at all times as a backup. Medical personnel must be trained in the use of the backup system. Medical personnel must be available in the hos- pital at all times.
Page 31: Diagnostic Procedure, Emc
Safety Information Do not use the EXCOR Active in the vicinity of flammable gases! Oth- erwise, there is a risk of explosion from ignition of the gas mixture. Maintain and monitor correct storage conditions for all EXCOR System components, see Section 20.9.2: Storage Conditions, page 223. Fail- ure to maintain correct storage conditions could damage components, shorten product life, and delay usability in emergency situations.
Page 32: Power Supply
Safety Information Only connect electrical components to fixed mains socket-outlets. Do not use extension cables. Take into account the protection class of the power outlet and components! Do not touch the electrical contacts on a component and the patient at the same time.
Page 33: Setup And Function
Driving unit Driving unit Setup and Function 5.1.1 Principal Function The driving unit includes two pneumatic units. Each pneumatic unit consists of one cyl- inder, inside of which a piston moves. The piston motion alternately produces driving and suction pressures. These alternating pressures are transferred to the blood pump via the driving tube.
Page 34: Setup
Driving unit The driving unit can be operated using mains power or two batteries. An integrated emergency battery is available as reserve. 5.1.2 Setup 1 Control Panel 2 Handle 3 Batteries 4 Seal cap for USB cable connector (connection to panel PC) 5 Seal cap for connector for external alarm (nurse call) 6 Ventilation openings...
Page 35: Connections And User Controls
Driving unit Connections and User Controls 5.2.1 Control Panel The control panel is divided into two sides. The red side is used to control left circula- tory support, and the blue side controls right circulatory support. The connection for the power supply unit is located in the middle. The red and blue driving unit sides are laid out identically.
Page 36: Display
Driving unit Navigation through The display switches to the next the views view. Navigation through The next alarm is displayed. the alarm list Switching off the driv- Press both <but- view is displayed. HUTDOWN ing unit tons> simultane- The driving unit can be turned off by ously for approx.
Page 37 Driving unit Status bar symbols The status bar provides information on current driving unit status. Information is shown using symbols. Symbol Meaning LARM An alarm condition is in place. The driving unit emits audible signals. Once the alarm condition has been rectified, the symbol disappears. If the <button>...
Page 38 Driving unit ELATIVE STATE OF CHARGE AND CHARGING DISPLAY FOR BATTERIES EMERGENCY BATTERY Shows the relative state of charge of the battery as well as ATTERY the charging display. If the battery is charging, the symbol will be animated. If the battery is not charging, the charge level will be displayed.
Page 39 Driving unit Operation view After start-up and when in error-free operation, the display appears as shown in Fig. 5-7 . If an alarm condition occurs, the display will indicate the alarm code, the message, and the total number of alarms. Fig.
Page 40 Driving unit Flow display view Displays the current flow for the left and / or right blood pump. 1 Display of the current flow left in [l/min] 2 Display of the current flow right in [l/min] Fig. 5-9 Display view – flow; LVAD Info view Display showing the current driving unit parameters.
Page 41 Driving unit 1 Driving unit software version 2 Expected Maintenance date 3 Pump cycles Fig. 5-11 Display view – Maintenance The following is displayed: Pump cycles conducted / number of cycles after which maintenance is required Expected date of next maintenance Driving unit software version Regularly scheduled maintenance must be performed as soon as at least one pneu- matic unit has performed 34 million pump cycles or one year has elapsed since main-...
Page 42 Driving unit Shutdown 1 Countdown: time to disconnect the power supply in seconds 2 Shutdown symbol Fig. 5-13 Display view – Shutdown If both <buttons> are pressed for five seconds, the symbol appears. The HUTDOWN driving unit can now be disconnected from the power supply. The driving unit switches off after the disconnection.
Page 43: Connections
Driving unit A driving unit that has not yet been configured will automatically perform a start test when starting up, see Section 5.4: Start Test for the Driving Unit, page 56. An hourglass will be shown for the duration of the start test. 5.2.2 Connections WARNING...
Page 44: Connections For Lvad, Rvad And Bvad Operating Modes
Driving unit 5.2.2.2 Connections for LVAD, RVAD and BVAD Operating Modes LVAD The red marked driving tube and the flow sensor are connected to the red-marked drive side on the left. The right driving tube connector remains closed. RVAD The blue marked driving tube and the flow sensor are connected to the blue-marked drive side on the right.
Page 45: Connecting The Power Supply Unit On The Driving Unit
Driving unit To pull out the connector plug, grasp the ribbed area and pull upwards. 5.2.2.4 Connecting the Power Supply Unit on the Driving Unit Open the cap. Grasp the plug by its ribbed body (1). Align the markings on the plug and the connection socket (2).
Page 46: Connecting The Adapter For External Alarm
Driving unit Open the top cover. Plug the USB cable into the driv- ing unit. 1 Cover 2 USB connector Connect the USB cable to the panel PC / the docking station. 3 USB cable on panel PC 5.2.2.7 Connecting the Adapter for External Alarm The adapter for the external alarm connects the driving unit with a hospital alarm sys- tem.
Page 47: The Flow Sensor
Driving unit 5.2.3 The Flow Sensor WARNING Flow measurement is only active when the flow sensors are connected to the driving unit and the cannulae. Flow alarms are only emitted if a flow alarm threshold has been set. If no flow sensors are connected or no flow alarm threshold has been set, monitor the blood pumps to ensure that they are filling and empty- ing completely.
Page 48 Driving unit Color marking 1 Sensor locking clip 2 Protective cap 3 Sensor quick connect 4 Stop 5 Sensor cable 6 Underside with vent slots Fig. 5-20 Flow sensor and color marking, protective cap 1 Cannula 2 Flow sensor 3 Sensor locking clip 4 Protective cap 5 Mirror 6 Sensor quick connect...
Page 49 Driving unit FS12-012-C Fig. 5-23 Flow sensors for blood pumps with bileaflet valves (FS09-12-C not shown) 1 Cannula diameter 2 Connector diameter 3 Blood pump type, pursuant to information on flow sensor and blood pump: P10P-001 or P50C-001 FS06 - 06 - P Fig.
Page 50: Measurement Precision And Alarms
Driving unit Cannula diameter Blood pump For blood pumps connector with diameter FS09-12-C 9 mm/12 mm with use 12 mm Bileaflet valve of staging FS12-12-C 12 mm 12 mm Bileaflet valve Tab. 5-1 Flow sensor model overview 5.2.3.2 Measurement Precision and Alarms As with all measurement processes, flow measurements have a certain degree of pre- cision.
Page 51: Removing The Flow Sensor From The Cannula
Driving unit Attach the flow sensor to the cannula. The cable always points toward the blood pump. Positioning: Flow sensors for blood pumps with PU valves have a defined stop position. The stop must be positioned precisely where the step of the connector will prevent the can- nula from being pushed any fur- Fig.
Page 52: Replacing The Sensor Quick Connect
Driving unit Removing the sensor locking clip Open the sensor quick Simultaneously press the When the snap-in tabs are connect. To release a sen- top of the sensor locking free, remove the sensor sor locking clip, lightly clip with the other hand so locking clip.
Page 53: Connecting / Disconnecting The Flow Sensor To / From The Driving Unit
Driving unit Replace worn or lost sensor quick connects. Matching sensor quick con- nects are available for all sizes of flow sensors. Fig. 5-29 Sensor quick connect for flow sen- sors FS06, FS09, FS12 5.2.3.6 Connecting / Disconnecting the Flow Sensor to / from the Driving Unit Grasp the connector plug under- neath by the ring.
Page 54: Removing The Cable Wrap
Driving unit Attach the cable wrap to the wrapping tool Slowly guide the wrapping tool along the cable wrap with one hand, while grasping the cable wrap with the other. Avoid creat- ing tensile force on the blood pump or the cannulae. At the end, guide the driving tube and sensor cable out of the wrapping tool.
Page 55: Carrying System And Locking Mechanism
Driving unit 5.2.4 Carrying System and Locking Mechanism WARNING Only lift and carry the driving unit using the handles intended for that purpose, meaning the handle on the driving unit and the handle on the caddy. Otherwise, safe and proper operation of the EXCOR is not guar- anteed.
Page 56: Setup Of Mobile Components
Driving unit 5.2.4.2 Setup of Mobile Components 1 Mounting hook 2 Mount Switching On the Driving Unit The driving unit will switch on as soon as it is connected to a power supply. Its power supply sources include: • connection to the mains via a power supply unit •...
Page 57: Switching Off The Driving Unit
Driving unit sages like S1 because messages will not disturb patients while they AINTENANCE DUE are awake. Switching Off the Driving Unit The following procedure should be used to switch off the driving unit. Initial state: The driving unit is connected to mains power; batteries are inserted.
Page 58: Batteries
Driving unit If mains and battery operation are both unavailable, the emergency battery will supply power. A secure power supply is fundamental to uninterrupted operation. Select locations and plan mobile use such that the power supply is guaranteed at all times. Keep in mind that mains power, batteries, or the power supply unit could potentially fail.
Page 59: Removing The Batteries
Driving unit 1 Locking plate 3 Lower guide 2 Upper guide 4 Contacts Fig. 5-31 Inserting the battery into the battery slot 5.7.1.2 Removing the Batteries To remove a battery, reach into the recessed grip. Press the button inside the recess upwards. Pull the battery upwards to remove it.
Page 60: Charging Time
Driving unit 5.7.1.6 Charging Time Batteries charge most quickly at room temperature. Cold batteries will not charge. Bat- teries may be cold as a result of having been transported at temperatures below 0 °C or brought along during mobile operation. Allow the batteries to acclimatize. The bat- teries will begin charging at 5 °C.
Page 61: Determining Charge Level
Driving unit 5.7.1.8 Determining Charge Level Charge level provides a basis for estimating the driving unit’s approximate runtime. Charge level is displayed on components as follows: Relative Driving unit and Battery Battery Emer- Battery Charge level Panel PC dis- charging gency charging charging...
Page 62 Driving unit LVAD 10 ml Driving unit oper- ating time during battery operation 6 mm/5 mm cannulae, rate 70 bpm, systole 50 %, min. 10:45 h preload 15 mm Hg, afterload 75 mm Hg LVAD 80 ml Driving unit oper- ating time during battery operation 12 mm/12 mm cannulae, rate 70 bpm, systole 50 %,...
Page 63: Notes On Replacing The Batteries
Driving unit Influencing factors Driving unit operating time in battery operation BVAD, LVAD or RVAD In BVAD operating mode, both pneumatic units are operating mode operated, whereas only one is operated in LVAD or RVAD mode. As such, system operating time is com- paratively longer in LVAD and RVAD operating modes.
Page 64: Power Supply Unit
Driving unit 5.7.2 Power Supply Unit Power supply units supply power to the driving unit or battery charging unit. The same power supply unit is used for the driving unit and the battery charging unit. The mains operation indicator illuminates green as soon as the power supply unit is supplied with power.
Page 65: The Battery Charging Unit
Driving unit Initial state: driving unit without mains power or batteries Prepare the power supply unit. Press and hold one of the two <but- tons> on the control panel of the driv- ing unit. At the same time, connect the driving unit to mains power.
Page 66: Setup
Driving unit 5.8.1 Setup The battery charging unit can charge two batteries separately and simultaneously. 1 Battery charging unit 4 Battery status LEDs for the battery slot 2 Battery inserted Battery slot ready and Battery slot 3 Charge activity indicator defective / too warm Battery charging and Battery defective 5 Battery slot...
Page 67: Function
Driving unit 5.8.2 Function Batteries charge the fastest at room temperatures of between 19 °C and 23 °C. Al- ways charge batteries completely whenever possible. Connecting the battery charging unit Connect the power supply unit to the battery charging unit. Check readiness for operation.
Page 68: Connecting Electrical Components
Driving unit Connecting Electrical Components 1 Power supply unit 8 Docking station 2 Adapter for external alarm 9 Panel PC power supply unit 3 Batteries 10 Battery charging unit 4 Driving unit 11 Flow sensor, right 5 USB cable 12 Flow sensor, left 6 USB stick 13 Power cable (country-specific) 7 Panel PC...
Page 69 Driving unit Compare the patient ID information on the driving unit and the replacement driving unit. The patient ID can be found on the rear side of the driving unit. Check whether the selected replacement driving unit is intended for the patient.
Page 70: Replacing Driving Units For Lvad And Rvad Patients
Driving unit 5.10.2 Replacing Driving Units for LVAD and RVAD Patients 5.10.2.1 Checking the Function of the Unconfigured Driving Unit and Panel PC Have the panel PC and driving unit ready. Connect the panel PC to the mains and switch it on. Supply the driving unit with power.
Page 71: Performing A Driving Unit Replacement
Driving unit If settings need to be changed, switch to the corresponding view. Make the necessary changes. If all settings are correct, press . The settings are transferred to the driv- PPLY ing unit. Open the left driving tube connector for LVAD, the right driving tube connector for RVAD.
Page 72: Bvad Emergency Operation
Driving unit In the view, select the but- ETTINGS BLOOD PUMPS LOW ALARM THRESHOLD ton. Set the Flow alarm threshold. 10. Switch off the driving unit that is no longer in use. Switching off, see Section 5.6: Switching Off the Driving Unit, page 57. Close any open connec- tions.
Page 73: Panel Pc And Docking Station
Panel PC and Docking Station Panel PC and Docking Station Safety Information WARNING The panel PC is intended for mains operation. Battery operation should only be used for transportation within the hospital. The panel PC must not be connected to a driving unit that is supporting a patient while the batteries are being replaced.
Page 74 Panel PC and Docking Station Front view and rear view 1 Cover for connections 7 HDD display 2 USB 3.0 8 Touchscreen 3 USB 2.0 9 Power On / Off 4 Cover closed 10 Connections for docking station 5 Locking mechanism 11 Power connector 6 Charge level display 12 Centering for docking station...
Page 75: Supplying Power With The Panel Pc Power Supply Unit
Panel PC and Docking Station Touchscreen The panel PC offers a touch screen. It recognizes entries made wearing surgical gloves. Tapping Tap an element to activate a button. Sliding Tap and slide an element to select a value. Swiping Swipe across the screen using one or more fingers to move to the next view.
Page 76: Supplying Power Using Batteries
Panel PC and Docking Station 1 Panel PC power supply unit 2 Plug for panel PC 3 Power supply unit On / Off display 4 Mains power connector Fig. 6-3 Panel PC power supply unit Connecting the power supply unit to the panel PC Open the panel PC cap.
Page 77: Docking Station
Panel PC and Docking Station Inserting the battery Open the locking mechanism. To do so, slide the lock toward the right. Place the battery in the mount. Close the locking mechanism. To do so, slide the lock toward the 1 Bolt, right = open left.
Page 78: Panel Pc And Docking Station
Panel PC and Docking Station 1 unlocked 2 locked 3 Charge level display for the battery in the docking station • Green: battery charged (> 95 %) • Orange: battery is charging 4 Display for the panel PC – docking station connection •...
Page 79: Connecting The Panel Pc To A Driving Unit
Panel PC and Docking Station Pressing the <Power On / Off> button for a longer period will also power down the panel PC. Only use this method in the event of errors. This method does not allow the software and the operating system to be shut down safely. Restarting the panel PC If the user interface does not respond or cannot be read, restart the panel PC.
Page 80 Panel PC and Docking Station 1015002x03...
Page 81: User Interface
User Interface User Interface General The user interface starts when the panel PC is switched on. The user interface allows users to adjust driving unit and panel PC settings. Inactive functions and information are grayed out or hidden. Information on the status of the driving unit and the panel PC is shown in the status bar.
Page 82: File And Menu Bar
User Interface 7.1.1 File and Menu Bar pull-down menu is located on the top left. The File menu contains general functions for operating and configuring the panel PC and driving unit. The menu bar offers access to the most important functions and views of the user in- terface.
Page 83: Status Bar
User Interface CTIVE ALARM High-priority alarms: flashing red bell symbol, error shown along with troubleshooting instructions. Only visible when a high-priority alarm is being emitted. Active medium-priority alarm: flashing yellow bell symbol, error shown along with troubleshooting instructions. Only visible when a medium-priority alarm is emitted and a high-priority alarm is not present at the same time.
Page 84: Buttons
User Interface Displays the user logged in ]. If no user EDICAL XPERT OCAL is logged in, nothing will be shown. ANEL DATA TRANSMISSION DISPLAY Animated depiction of data transmission from the driving unit to the panel PC. Only shown if data transfer takes longer than three seconds.
Page 85: Functions Of The Menu Bar
User Interface Some buttons show the value of a parameter. If the button is pressed, a window opens. The value of the parameter can be set in the win- dow. Views Menus with multiple views are displayed using dots. The active view is marked and labeled. Slider control Slider controls allow parameters to be set by sliding the bar.
Page 86 User Interface User Use case Display and analysis of historical data, driving unit not con- OCAL nected to the panel PC Performance of medical procedures such as implantation, XPERT explantation, revision, weaning, or blood pump replacement. Precondition: Driving unit and panel PC are connected via USB cable.
Page 87: Passwords
User Interface User Access rights possesses access to all functions of the driving unit EDICAL EDICAL and the panel PC. Exceptions and special circumstances: • is automatically logged off if no action is taken on EDICAL the user interface for 10 minutes. •...
Page 88: Monitoring
User Interface Monitoring Monitoring is the view used to monitor the patient. The parameters Flow, Rate, and Flow alarm threshold are displayed. The current values for the blood pump on the left side of the heart are displayed on the left. Those for the blood pump on the right side of the heart are displayed on the right.
Page 89 User Interface Fig. 7-3 Settings for the blood pumps – Parameters – Manual pressure control view Parameter Overview Pressure curves Display of Pressure Curves Pressure control Manual / Automatic pressure control Synchronization Synchronous / Asynchronous / Separate mode Start / Stop Starting and stopping of blood pumps Counter Time until the driving unit finishes self-regulation;...
Page 90 User Interface Parameters for setting the blood pumps Parameter Description Manual pressure con- Manual pressure control is only intended for sup- trol porting the patient temporarily during procedures such as implantation, explantation, revision, and blood pump replacement. In particular, manual pres- sure control should be used while the patient’s tho- rax is open.
Page 91 User Interface Parameter Description Piston stroke The piston stroke indicates what percentage of the possible distance the piston covers within the pneu- matic unit. The piston stroke determines the air vol- ume that is driven into or suctioned out of the blood pump.
Page 92 User Interface Selection of synchronization Parameter Description Synchronization Synchronization of the blood pumps can only be selected in BVAD operating mode. These settings determine whether the right and left blood pumps are operated in Synchronous mode, Asynchronous mode, or Separate mode (independently of one another).
Page 93: Display Of Pressure Curves
User Interface Fig. 7-5 Settings – Start-Stop Step left With each press of this button, the left blood pump is filled or emptied. Pressing 2x equals one pump cycle. Auto / Pause Starts or stops the continuous operation of the left blood pump.
Page 94 User Interface Fig. 7-6 View with manual pressure control active Fig. 7-7 View with automatic pressure control active 1015002x03...
Page 95: Settings For The Driving Unit
*. Without entering a weight, a recommendation cannot be shown and an indication can also not be made for recom- mended Berlin Heart pump-cannula combinations. The weight parameter can be changed at a later time. Implantation date Date of implantation.
Page 96 User Interface Parameter Description Child lock Switching the child lock on and off Pausing of acoustic alarms can be delayed by 15 s. To do this, the child lock must be activated. The child lock ensures that children or unauthorized persons cannot pause acoustic alarms before hospital personnel or caregivers have a chance to notice them.
Page 97: Blood Pumps And Cannulae
User Interface 7.5.2 Blood Pumps and Cannulae Fig. 7-9 Blood pumps and cannulae First, select the operating mode in the window. Next, se- LOOD PUMPS AND CANNULAE lect the size of the implanted blood pumps and cannulae. The values entered here are critical for the correct regulation of the suctioning and driving pressures.
Page 98: Data
User Interface Fig. 7-10 Settings Data 7.6.1 File The File button opens a menu bar with the following items: • Files..., see Section 7.6.2, Page 99 • Options..., see Section 7.6.3, Page 99 • System information, see Section 7.6.4, Page 101 •...
Page 99: Files
User Interface 7.6.2 Files Fig. 7-12 Files... menu opens a menu in which ILES • log files can be imported from the driving unit to the panel PC • log files can be exported from the panel PC to a USB stick •...
Page 100 User Interface Setting the language opens a window containing a list of available languages. The ANGUAGE FOR PANEL language can be selected by pressing the corresponding button. Setting date and time opens a window for setting the date and time on the panel PC. ATE AND TIME The time is set using two rotary knobs (hours and minutes).
Page 101: System Information
User Interface 7.6.4 System Information 1 Manufacturer’s specifications 2 Pump cycle counter 3 Maintenance due: calculated maintenance date 4 Information on the software versions of the individual driving unit components The calculated date of next maintenance is not a fixed value. The date of next main- tenance is estimated based on the current rate.
Page 102: Switching Off The Panel Pc
User Interface The driving unit settings can only be reset when the blood pumps are stopped / have not yet been started. 7.6.6 Switching Off the Panel PC Fig. 7-15 Switch off panel PC... menu button shuts down the user interface and switches off the WITCH OFF PANEL panel PC.
Page 103: Trend Info
User Interface All past messages can be found under Progression. Tapping the column header will make an arrow appear. Tapping the arrow allows alarms to be sorted according to the corresponding categories. If the panel PC is connected to a driving unit, the alarms for the connected driving unit are displayed.
Page 104: Active Alarms
User Interface Navigating within the Trend info window – moving To move the displayed area, tap the screen once. Arrows will appear at the edges of the image. Use one finger to move the displayed area. Tapping the screen again will hide the arrows;...
Page 105: Audio Paused
User Interface Fig. 7-19 Alarm message Audio Paused Mutes the alarm for a designated period of time (Chapter 17.3.7: Acoustic Alarms on the Driving Unit, page 180). Fig. 7-20 Audio paused button 7.10 Ackowledged WARNING When using : Monitor visual signals by the driving unit CKOWLEDGED and the panel PC, the filling and emptying of the blood pumps, and the status of the patient.
Page 106: Messages
User Interface 7.11 Messages The information appearing in the window concerns the panel PC or com- ESSAGES munication between the panel PC and the driving unit. Messages that concern the safety of the patient are not shown in the window. ESSAGES When a message arrives, it is briefly shown on the bottom right.
Page 107: Configuring And Operating The Driving Unit
Configuring and Operating the Driving Unit Configuring and Operating the Driving Unit General This section describes all procedure steps that must be performed on the EXCOR Ac- tive system. Handling of the sterile components such as the blood pumps is described in the “EXCOR Sterile Components”...
Page 108: Checking The Functionality Of A Configured Replacement Driving Unit
Configuring and Operating the Driving Unit Check the following items on the driving unit: • Did the start test complete without errors? • Are the displays active? • Can an acoustic alarm be heard when the buttons are pressed? Check the following items on the panel PC: •...
Page 109: Blood Pumps - Cannulae - Maximum Rate
Configuring and Operating the Driving Unit Parameter Default setting Language English Child lock Synchronization type Synchronous mode Pressure control Manual left right Systole [mm Hg] 100 mm Hg 80 mm Hg Diastole [mm Hg] 0 mm Hg 0 mm Hg Rate 20 bpm 20 bpm...
Page 110: Selection Of Blood Pumps And Cannulae
Configuring and Operating the Driving Unit Influence of elevation on maximum rates The ambient atmospheric pressure influences the performance of pneumatic systems. The driving unit is equipped with pressure sensors that allow it to measure and com- pensate for ambient air pressure. Depending on the status of the patient and the can- nulation selected, it may not be possible to fully compensate for the influence of low atmospheric pressure at great altitudes.
Page 111: Configuration Options - Overview
Configuring and Operating the Driving Unit Acoustic alarm signals are only emitted during the start test and when the blood pumps are operating in automatic mode. An acoustic alarm is not emitted in single-step mode or when one or both blood pumps are stopped.
Page 112: Configuring The Driving Unit - Manual
Configuring and Operating the Driving Unit 8.5.2 Configuring the Driving Unit – MANUAL 8.5.2.1 Starting Configuration Initial state: The driving unit is connected to the panel PC. Both devices are on. The driving unit is not yet configured or the driving unit was reset. The panel PC will log in automatically as user XPERT In the...
Page 113: Selecting Settings For The Driving Unit
*. If no weight is entered, a recommendation cannot be dis- played. There may not be any information provided to the effect that the selected pump-cannula combination does not conform to the recommenda- tions of Berlin Heart. Accept entry. Press MPLANTATION DATE Select the date of implantation in the calendar.
Page 114 Configuring and Operating the Driving Unit For the parameter settings • Operating mode, • Blood pump, and • Cannula inflow I outflow always open the respective window and confirm the setting by pressing . This PPLY applies even if the parameter setting is already correct and does not need to be changed.
Page 115: Checking The Settings And Transferring To The Driving Unit
Configuring and Operating the Driving Unit 10. If the pump-cannula combination selected does not conform to Berlin Heart recommendations, a message will appear. Nonetheless, any permissible combination can be selected. 11. Proceed to Chapter 8.5.2.5: Checking the Settings and Transferring to the Driving Unit, page 115.
Page 116: Selecting Manual / Automatic Pressure Control
Configuring and Operating the Driving Unit In the view, press the button. ONFIGURE DRIVING UNIT ROM FILE The available configuration files will be displayed. Select configuration files and confirm. Proceed to Chapter 8.5.2.5: Checking the Settings and Transferring to the Driving Unit, page 115.
Page 117: Airing, Starting, And Setting The Blood Pumps
Configuring and Operating the Driving Unit De-Airing, Starting, and Setting the Blood Pumps WARNING Do not set blood pumps solely on the basis of achievable and displayed flow. Always also make sure that the blood pump/s is/are filling and emptying completely. Select a suitable systolic duration. The goal is to generate sufficient flow for the patient’s needs.
Page 118: Bvad
Configuring and Operating the Driving Unit Ensure complete de-airing in single-step mode. Check the tightness of the connections. Check the anastomosis and the connections between the com- ponents (cannulae to blood pump; connecting set and extension set, if appli- cable). After conducting one step, the blood pump can be started with .
Page 119: Setting Rate And Synchronization
Configuring and Operating the Driving Unit 8.6.4 Setting Rate and Synchronization WARNING Only select rates below 60 bpm during implantation, explantation and weaning. Do not set rates below 60 bpm on a long-term basis. When using rates below 60 bpm, monitor blood pump filling and emptying, and conduct visual inspections for deposits and thrombi.
Page 120: Blood Pump Phases
Configuring and Operating the Driving Unit 8.6.5.1 Blood Pump Phases Filling of blood pump through movement of the membrane to the diastolic end posi- tion. 1. Suctioning of blood 2. Diastolic end position Emptying of blood pump. 3. Ejection of blood pump 4.
Page 121: Manual Pressure Control - Optimizing Filling And Emptying
Configuring and Operating the Driving Unit brane can reach the end position very quickly and pause in the respective end position. This can increase the risk of the formation of deposits. • Manual pressure control: Adjust pressure levels in [mm Hg] for Systole Diastole step by step, see Section 8.6.5.3: Manual Pressure Control –...
Page 122: Switching From Manual To Automatic Pressure Control
Configuring and Operating the Driving Unit Repeat the setting process until the membrane is crease-free in both end positions. In doing so, take into account that the settings for one end position can also have an effect on the opposite end position. Keep the pressure set- tings as low as possible.
Page 123 Configuring and Operating the Driving Unit figured while the patient is lying down. In the course of mobilization, conduct gradual adjustments. Baseline situation: The blood pump is connected, de-aired, and has been started. The driving unit is connected to the panel PC and the user is logged Goal: The blood pump fills and empties completely.
Page 124: Displaying The Pressure Curves
Configuring and Operating the Driving Unit 8.6.6 Displaying the Pressure Curves In the work area, a pressure curve is displayed for each blood RESSURE CURVES pump. In BVAD operating mode, the button can be used to select ISPLAY CURVES whether the pressure curves for the left, right, or both sides are displayed. Swipe to switch quickly between the views.
Page 125: Setting A Flow Alarm Threshold
Configuring and Operating the Driving Unit porting the patient and the patient’s thorax is closed. The flow sensor can be attached to both the inflow cannula as well as the outflow cannula. Among BVAD patients, po- sitioning on the outer cannulae is preferred. Any orientation is possible. After the intraoperative initial start of the blood pumps, the EXCOR Active system needs the flow sensors to be connected once 4 hours have passed.
Page 126: Postoperative
Configuring and Operating the Driving Unit Call up the view. Set the value for the Flow LOOD PUMPS ARAMETERS alarm threshold for each flow sensor separately. 1 Lower threshold for the flow alarm 2 Currently selected value 3 Upper threshold for the flow alarm Set the value for the flow alarm threshold and press to confirm.
Page 127: Mobilizing Patients
Configuring and Operating the Driving Unit Parameter Blood pumps Blood pumps stopped started – continu- ous operation Patient information and driving unit settings Parameter settings for the blood pumps Blood pump size Operating mode Operating modes can only (BVAD, LVAD, RVAD) be changed after the driving unit is reset.
Page 128: Changing The Blood Pump Size
Configuring and Operating the Driving Unit Checking the support while sitting Ask the patient to sit on the edge of the bed for 5 to 10 min and check the fill- ing behavior of the blood pumps. If filling / emptying worsens, adjust the parameters. Checking the support while standing Ask the patient to get up out of bed for 5 min.
Page 129: Changing The Operating Mode
Configuring and Operating the Driving Unit Tap the button and use the rotary field to select the desired size LOOD PUMP of the blood pump or blood pump combination. Press to confirm. PPLY Switch to the view and operate the blood pump(s) in LOOD PUMP SETTINGS single-step mode.
Page 130: Driving Unit Configuration Not Yet Complete
Configuring and Operating the Driving Unit 10. Adjust the settings for Operating mode, Blood pump Cannula inflow | outflow. Apply the settings. 11. Switch to the view and de-air the blood pump(s) in LOOD PUMPS SETTINGS single-step mode. After de-airing completely, start the blood pump(s). 12.
Page 131: Replacing And Upgrading The Blood Pump
Configuring and Operating the Driving Unit Replacing and Upgrading the Blood Pump Heed the instructions for use on EXCOR sterile components! WARNING Before switching to a different blood pump size, check whether a differ- ent flow sensor will be required. Information on which sensors can be used with which blood pumps and cannulae is available here: Tab.
Page 132: Replacing The Blood Pump - Bvad Right
Configuring and Operating the Driving Unit Perform de-airing in single-step mode. Check that the system is completely de-aired. Do not start the blood pump until the system has been completely de-aired. Check the tightness of the connections. In the event of a blood pump upgrade: See Chapter 8.8.4: Changing the Blood Pump Size, page 128, steps 5 and 6.
Page 133: Replacing The Driving Tube
Configuring and Operating the Driving Unit 10. In the event of a blood pump upgrade: See Chapter 8.8.4: Changing the Blood Pump Size, page 128, steps 5 and 6. 11. Start the blood pumps. Adjust the rates. 12. Check blood pump filling and emptying; optimize if necessary. 13.
Page 134: Replacing The Driving Tubes - Bvad Right
Configuring and Operating the Driving Unit 10. Mount the flow sensor and cable wrap. 11. Log off. 8.10.2 Replacing the Driving Tubes – BVAD Right Initial state: System is in operation. The panel PC is connected to the driving unit. Driving tube with blue color marking is ready. Log on as user XPERT Remove the cable wrap.
Page 135: Replacement Driving Unit - Updating Configuration
Configuring and Operating the Driving Unit Go to the view and press the ONFIGURATION EPLACE button. MENT DRIVING UNIT Replacement driving units can only be configured using function. This is the only EPLACEMENT DRIVING UNIT function that will yield a driving unit that starts pump operation as soon as it is supplied with power in an emergency.
Page 136: Switching Off And Restarting The Driving Unit
The driving unit monitors and logs a variety of driving unit parameters and saves them in logs. Logs contain, for example, pressure and flow curves or messages. The logs can help Berlin Heart with error analysis. The following logs are created: •...
Page 137: Importing Logs
PC, the data must first be imported from the driving unit. Even if logs are to be sent to Berlin Heart for error analysis, they must first be copied from the driving unit to the panel PC.
Page 138: Exporting Logs
Configuring and Operating the Driving Unit Automatically import logs This function copies long-term logs and event logs onto the panel PC as soon as the panel PC is connected to the driving unit. Log files that are already on the panel PC are not re-imported.
Page 139: Exporting Configurations
Configuring and Operating the Driving Unit 8.13.5 Exporting Configurations The Exporting configuration... function copies the selected configuration to a connect- ed USB stick. The selected configuration is always one that is saved on the panel PC. Log in. Connect the USB stick to the panel PC. Only one USB stick may be con- nected to the panel PC.
Page 140 Configuring and Operating the Driving Unit 1015002x03...
Page 141: Replacing The Driving System
Replacing the Driving System Replacing the Driving System General This section describes all steps that must be performed on the driving unit of the EX- COR Active system. Make sure to consult the Ikus instructions for use regarding ac- tions to take on the Ikus and configuration of that driving system. Heed the instructions for use on the EXCOR driving system! For information and specifications on blood pumps and cannulae, be sure to consult the “EXCOR Sterile Components”...
Page 142: Switching To The Excor Active
Replacing the Driving System Configuring the driving unit, see Abschnitt 8.5: Configuring the System, Seite 110. Transfer the following parameters from the Ikus to the EXCOR Active (for both supported sides if using in BVAD mode): • Operating mode • Cannula sizes •...
Page 143: Excor Active To Ikus
Replacing the Driving System EXCOR Active to Ikus 9.3.1 Preparing the Ikus Switch on and configure the Ikus, see the Ikus instructions for use. Transfer the parameters from the EXCOR Active driving unit to the Ikus. The following information is transferred (for each supported side in BVAD mode): •...
Page 144 Replacing the Driving System 1015002x03...
Page 145: Weaning And Explantation
Weaning and Explantation Weaning and Explantation 10.1 General This section describes all procedure steps that must be conducted on the driving unit. Handling of the sterile components such as the blood pumps is described in the “EX- COR Sterile Components” instructions for use. 10.2 Weaning the Patient Longer periods of blood pump stoppage or blood pump operation at a very low rate are both unfavorable in terms of hemostasis and risk of thrombogenesis.
Page 146 Weaning and Explantation 1015002x03...
Page 147: Performing Trainings
Performing Trainings 11.1 Target Group for Trainings 11.1.1 Qualified Medical Personnel Berlin Heart offers training sessions for qualified medical personnel. Contact Berlin Heart or the Distributor to schedule training dates, see Chapter 1: Contact, page 13. 11.1.2 Lay Users The EXCOR Active is suitable for use by users without specialist medical knowledge.
Page 148: Training Content Checklists
Performing Trainings 11.3 Training Content Checklists 11.3.1 Operating Components Training of patient and caregivers Check Function Functionality of the driving unit Connecting components Calling up display views and knowing what they mean Connecting the driving unit to mobile components Positioning cannulae, blood pumps, and driving tubes Attaching driving tubes and sensor cables to mobile components Power Supply Charging batteries in the driving unit...
Page 149: Behavior And Safety
Performing Trainings Training of patient and caregivers Check Attaching and detaching the cable wrap Sensor locking clip – flow sensor color marking Corrective action in the event of a defective flow sensor (Contact the hospital and have the defective flow sensor replaced) Information on components by other manufacturers Using the stroller / baby carrier components Safety information regarding stroller / baby carrier...
Page 150: Training Protocols
Performing Trainings Safety Check Psychological support Caregiver Special ambient conditions – recognizing dangers Stairs Bathroom Kitchen Mobility Maneuvering in public areas and recognizing dangers 11.4 Training Protocols Training Check Section 11.3.1: Operating Components, page 148 Section 11.3.2: Behavior and Safety, page 149 Contents and instructions as described in the “Instructions for Patients and Caregivers”...
Page 151: Mobile Use Of The Excor Active
Mobile Use of the EXCOR Active Mobile Use of the EXCOR Active 12.1 Help with Mobilization The following components are available for use when mobilizing the patient: • Caddy, Chapter 13: Caddy, page 153 • Baby buggy, Chapter 15: Baby Buggy – Stroller Board, page 165 Fig.
Page 152 Mobile Use of the EXCOR Active 1015002x03...
Page 153: Caddy
Caddy Caddy 13.1 Setup Fig. 13-2 Caddy with stand Fig. 13-1 Caddy with caster wheels 1 Handle 7 Stand 2 Hand strap 8 Locating pin to release the locking mecha- 3 Clip for driving tubes nism 4 Mounting hook 9 Mount 5 Mounting bracket for accessory bag 10 Wheel locking mechanism 6 Brake...
Page 154: Caddy - Mounting The Caster Wheels
Caddy 13.2.2 Caddy – Mounting the Caster Wheels 1 x caster wheel with support arm, left 1 x caster wheel with support arm, right 4 x Torx screws 1 x Torx wrench T30 Screw on the right (1) and left (2) support arm.
Page 155: Inflating The Wheels
Caddy Pull out the locating pin. Unfold the stand to the stop posi- tion and allow the locking handle to snap into place. Then mount the wheels, see Section 13.2.1: Assembling / Disassembling the Wheels, page 153. 13.2.4 Inflating the Wheels The caddy is available in versions with pneumatic tires and without pneumatic tires.
Page 156: Fastening The Hand Strap
Caddy Hang the accessory bag from the hook below and the fasteners from the crossbar above. Release the handle. Make sure that the accessory bag is seated firmly. 13.2.6 Fastening the Hand Strap The hand strap can be used to secure the caddy more safely, e.g. when climbing stairs.
Page 157: Conversion Of Caddy
Caddy 13.3 Conversion of Caddy 13.3.1 Caddy with Stand into Caddy with Caster Wheels 13.3.1.1 Components 1 x caster wheel with support arm, left 1 x caster wheel with support arm, right 4 x Torx screws 1 x Torx wrench T30 13.3.1.2 Assembly Only assemble and disassemble the caddy without driving unit and...
Page 158: Caddy With Caster Wheels Into Caddy With Stand
Caddy The caster wheel suspension is  set to the hardest level. Do not change this setting. Bag dismantled components and tools and store them in the com- ponent box for later reconver- sion. 13.3.2 Caddy with Caster Wheels into Caddy with Stand 13.3.2.1 Components 1 x stand 2 x clamping piece...
Page 159: Using The Caddy
Caddy Secure the stand (1) with the clamping pieces (2) and screw on the clamping pieces. The locating pin (3) should be posi- tioned as shown in the figure. Put the caddy upright. Bag screws and tools and store them together with the disman- tled support arms in the compo- nent box for later reconversion.
Page 160: Securing And Releasing Driving Tubes
Caddy 13.4.3 Securing and Releasing Driving Tubes Lay the driving tubes such that they will not tangle in the wheels or drag on the ground when in motion. Press the driving tubes into the clips. To release the driving tubes, pull them out of the clips.
Page 161 Caddy Remove the driving unit. Remove the wheels. Fold and lock the stand. Slide the handle downwards. Fig. 13-3 Caddy in transport position 1015002x03...
Page 162 Caddy 1015002x03...
Page 163: Accessory Bag
Accessory Bag Accessory Bag 14.1 Setup and Function 1 Flaps with magnetic closure 4 Closure 2 Battery compartment 5 Handle and opening contact for the locking 3 Pump compartment mechanism 6 Grommets for mounting bracket 14.2 Packing the Accessory Bag WARNING The accessory bag contains components that increase safety during mobile use.
Page 164 Accessory Bag 1 Two charged batteries 2 Manual pump 3 Short instructions for use 4 Air pump for the caddy (for version with pneumatic tires) 1015002x03...
Page 165: Baby Buggy - Stroller Board
15.1 Safety Information WARNING The stroller board may only be connected to a stroller that has been ob- tained from Berlin Heart. Otherwise, secure connections and safe us- age cannot be guaranteed. Activate the locking brake when parking the transportation system. The brake prevents the caddy from rolling away accidentally.
Page 166: Assembling The Stroller Board
Baby Buggy – Stroller Board 15.4 Assembling the Stroller Board 15.4.1 Checking the Scope of Delivery After unpacking, check the scope of delivery and lay out the parts. Name Units Body Carrier Wheel Countersunk screw Hook for bag Hexagon screw Sleeve Spacer set Stroller clip...
Page 167: Overview - Assembly
Baby Buggy – Stroller Board 15.4.2 Overview – Assembly 1 Hexagon screw 5 Countersunk screw 2 Hook for bag 6 Cap 3 Sleeve 7 Body 4 Carrier 8 Wheel Fig. 15-2 Stroller board assembly 1015002x03...
Page 168: Assembling The Stroller Board
The manufacturer’s instructions for use are included with each compo- nent. Take note of all instructions and safety information given in the in- structions for use. Strollers and child seats that are compatible with the stroller board can be ordered from Berlin Heart. 1015002x03...
Page 169: Set 1 - Frame
Baby Buggy – Stroller Board The stroller is designed for patients weighing up to 17 kg. Select either the child seat or the baby seat depending on the size and weight of the patient. Follow manufacturer recommendations. 15.4.5.1 Set 1 – Frame 1 Base frame 3 Sunshade 2 Set of wheels...
Page 170: Using The Child Seat And Baby Seat
Baby Buggy – Stroller Board 15.4.5.4 Using the Child Seat and Baby Seat Always mount the child seat / the baby seat in the direction of motion. Make sure that the child’s feet are facing forward. Do not put the child seat / the baby seat in a com- pletely horizontal position.
Page 171: Using The Stroller Board
Baby Buggy – Stroller Board 15.5 Using the Stroller Board Prerequisite • The stroller board is fully assembled. • The stroller board and stroller are connected to one another. • The stroller clips are mounted on the stroller. Before handling the patient or any components, the locking brakes on the stroller must be set.
Page 172 Baby Buggy – Stroller Board Fig. 15-3 Guiding of the driving tubes 1015002x03...
Page 173: Manual Pump
Manual Pump Manual Pump 16.1 General In a case of emergency, the manual pump can temporarily replace a driving unit. The manual pump is to be operated by qualified medical personnel trained in the use of the manual pump. Pumping for long periods of time is strenuous. Ideally, two persons should alternate operating the manual pump.
Page 174: Setup
Manual Pump 16.3 Setup 1 Handle 2 Driving tube connector for blue driving tube 3 Valves; one underpressure valve and one overpressure valve per side 4 Base plate 5 Driving tube connector for red driving tube 6 Plug Fig. 16-2 Setup of the manual pump 1 Color marking –...
Page 175: Supporting The Patient With The Manual Pump
Manual Pump 16.4 Supporting the Patient with the Manual Pump Two-handed operation One-handed operat Fig. 16-4 Support from the manual pump The patient should lie down. Remove the seal plugs from the driving tube connections. Always remove both plugs. This makes pumping easier. Detach the flow sensor(s) from the driving unit.
Page 176 Manual Pump 1015002x03...
Page 177: Identifying Errors And Troubleshooting
Caregivers treating hospital → Hospital Berlin Heart Hotline 17.2.2 Reporting Serious Incidents Serious incidents that occur in relation to the product are to be reported to Berlin Heart, as well as to the government office responsible in that country. 1015002x03...
Page 178: Driving Unit And Panel Pc Alarms
Identifying Errors and Troubleshooting 17.3 Driving Unit and Panel PC Alarms 17.3.1 Alarms If an alarm condition develops, an alarm will be emitted: Driving unit Panel PC External alarm Message Message and Detailed mes- Forwarding of instructions on sage and high- and the display instructions on...
Page 179: Noticing Alarms Reliably
Identifying Errors and Troubleshooting Priority Driving unit Panel PC medium System LED or battery Bell flashing yellow, alarm LED flashing yellow code on yellow back- ground Slow tone sequence every 7.5 seconds System LED, battery Bell continuously illumi- LED, or maintenance nated yellow, alarm code LED continuously illumi- on white background...
Page 180: Acoustic Alarms On The Driving Unit
Identifying Errors and Troubleshooting There is an LED for each group. If an alarm condition occurs, the corresponding LED illuminates. Display and meaning twice per sec- LASHING RED High priority alarm every two LASHING YELLOW seconds Medium priority alarm Continuous LLUMINATED YELLOW Low priority alarm Tab.
Page 181: Audio Off
Identifying Errors and Troubleshooting 17.3.8 Audio Off Acoustic alarms are switched off ) when the user is logged in as UDIO OFF XPERT and one or both blood pumps is paused / has not yet been started. EDICAL Fig. 17-2 Audio off 17.3.9 Saving Configurations and Logs Driving unit The driving unit is equipped with internal storage.
Page 182: Alarms For The Driving Unit
Identifying Errors and Troubleshooting Notice the alarm. Pause the audio. Do this by pressing the <button> on the driving unit. Read the message and instructions on the display. If the setting has been selected VERBAL for the drive, the alarm code is displayed, but not the message and instruction.
Page 183 Identifying Errors and Troubleshooting Alarm Message Instructions Information in the code and instructions for priority Pressure loss Check driving tube and Section 5.2.2.3, plug Page 44 Section 17.7, Page 187 Flow too low Check the driving tube, Section 17.7, blood pump and cannulae Page 187 Battery dis- Replace battery or con-...
Page 184 Identifying Errors and Troubleshooting Alarm Message Instructions Information in the code and instructions for priority Maintenance Notify contact person Emergency hotline Manual Pres- Switch to Automatic if Section 8.6.5.4, sure Control possible Page 122 active Driving unit Replace driving unit and Section 5.10, defective notify contact person...
Page 185: Panel Pc Alarms
Identifying Errors and Troubleshooting Alarm Message Instructions Information in the code and instructions for priority Flow sensor Disconnect flow sensor Section 5.2.3.6, too hot temporarily; notify con- Page 53 tact person Emergency hotline 17.5.2 Panel PC Alarms If the panel PC is connected to the driving unit, all alarms detected by the driving unit are also displayed on the panel PC.
Page 186 Identifying Errors and Troubleshooting Alarm Message Instructions code and priority Time limit for Manual End Manual Pressure Control if possi- Pressure Control ble. Using Manual Pressure Control reached! shortens the maintenance interval. Driving unit defective! Replace the driving unit and notify your contact person.
Page 187: Panel Pc Messages
Identifying Errors and Troubleshooting 17.6 Panel PC Messages Error message Solution The entry could not be applied. When troubleshooting, please proceed in this Please repeat the process. If order this occurs again, contact Berlin • Repeat the process; if this does not fix the Heart.
Page 188: Battery
Identifying Errors and Troubleshooting 1 +5 Fig. 17-3 alarms 17.8 Battery Battery errors are • displayed on the driving unit when the battery is in the driving unit • displayed by the battery charging unit when the battery is in the battery charging unit.
Page 189: S5 Pressure Build-Up Not Possible
Identifying Errors and Troubleshooting 17.11 S5 Pressure build-up not possible Self-test for <left / right> driving unit failed. Check the <left / right> driving tube con- nector and, if necessary, seal it with the seal plug. The test run is repeated. If the error cannot be rectified, there may be a leak inside the driving unit.
Page 190: Flow Sensor - Temperature Alarms
Identifying Errors and Troubleshooting Display Meaning Solution Error display The temperature of the Place the battery is perma- battery slot is too high. charging unit in a cooler nently illumi- location. nated. The battery slot is defec- tive. The battery charging unit must be replaced.
Page 191: Errors Without Messages
Identifying Errors and Troubleshooting In the event of a flow sensor temperature alarm, protect the skin of the patient. Follow the recommended instructions given in the warnings. Doing so will prevent skin dam- age. When treating patients whose ability to perceive heat is impaired as a result of medi- cations or comorbidities, position the flow sensor such that the underside with the vent slots is facing away from the body / is not touching the body.
Page 192: Functions Of The
Identifying Errors and Troubleshooting Error Solution Clamping or tight components Notify your contact person. Missing or illegible inscriptions or safety Notify your contact person. symbols Failure of a display Replace the driving unit. Display frozen, activity symbol showing Failure of backlight <Button>...

Page 193: Analyzing Driving Unit Logs
Identifying Errors and Troubleshooting Electromagnetic radiation as the cause • Are other electronic devices in the patient environment active, for example as part of therapy? • Is the patient in a different environment? • Do the changes in functionality occur during mobile use? Corrective actions •...
Page 194: User Interface Too Dark Or Not Reacting
Identifying Errors and Troubleshooting 17.21 User Interface Too Dark or Not Reacting User interface does not react If the user interface does not react or cannot be read, the panel PC can be switched off by pressing and holding <Power On/Off>. Briefly press <Power On/Off> to switch on again.
Page 195: Maintenance, Cleaning And Disinfection
Do not conduct service or maintenance work on components that are actively being used on patients. Otherwise, safe patient care cannot be guaranteed. Maintenance on the EXCOR Active is performed by Berlin Heart or the distributor. Do not perform any maintenance or repair work yourself. 18.2 Maintenance 18.2.1 Maintenance Personnel...
Page 196: Inspections By The Operator
Maintenance, Cleaning and Disinfection 18.2.2.2Shipment Place the components inside their intended packaging and send them to Berlin Heart / the distributor. If the original packaging is no longer available, additional packaging can be ordered from Berlin Heart. Component Packaging Driving unit and batteries...
Page 197: Power Supply Units
Disconnect the panel PC from mains power and operate it in battery opera- tion for at least 30 min. If the battery capacity is not sufficient to operate the driving unit for at least 30 min, contact Berlin Heart. 18.2.3.3 Power Supply Units Electrical test •...
Page 198: General Rules
Maintenance, Cleaning and Disinfection Prevent liquids penetrating into electrical components such as the driv- ing unit, panel PC, battery charging unit, docking station, batteries, and cables. Otherwise, there will be a risk of an electric shock and the com- ponents malfunctioning. 18.3.1 General Rules 1.
Page 199: Cleaning Agents And Disinfectants, Resources
All the specifications listed apply to CaviCide disinfectant. The time specifications for the clean- ing processes validated by Berlin Heart take into account an additional application time of one minute. Please bear in mind that other disinfectants may require different application times. To ensure reliable disinfection, add an additional application time of one minute to the application time specified by the manufacturer.
Page 200: Cleaning Intervals
Maintenance, Cleaning and Disinfection Non-approved cleaning agents and disinfectants × Colored and corrosive cleaning agents and disinfectants are not approved. Highly acidic or alkaline cleaning agents are not approved. Do not use any cleaning agents or disinfectants containing the following: •...
Page 201: Cleaning And Disinfecting The Driving Unit, Batteries, And Manual Pump
Maintenance, Cleaning and Disinfection Component When? Cleaning / Disinfection Flow sensor including pro- tective cap, sensor quick connect, and sensor locking See the Sterile Compo- clip nents instructions for use during each dressing change Cable wrap The cable wrap may only be used on one patient.
Page 202 Disinfection All the specifications listed below apply to CaviCide disinfectant. The time specifica- tions for the cleaning processes validated by Berlin Heart take into account an addi- tional application time of one minute. Please bear in mind that other disinfectants may require different application times. To ensure reliable disinfection, add an additional application time of one minute to the ap- plication time specified by the manufacturer.
Page 203 Maintenance, Cleaning and Disinfection Moisten a cloth with disinfectant. For 4 minutes, wipe down all external sur- faces that are accessible during use. Make sure that the surfaces are visibly damp for the duration of the required application time. Spray the handle (3) and the mounts for the seal plugs (1) directly with disin- fectant.
Page 204: Cleaning And Disinfecting The Flow Sensor
Maintenance, Cleaning and Disinfection 18.3.5 Cleaning and Disinfecting the Flow Sensor General The cable wrap may only be used on one patient. Dispose of the cable wrap after use on a patient. If the flow sensor is to be used on multiple patient, the flow sensor must be cleaned in an ultrasonic bath before switching from one patient to another, see work step 4 in the section that follows.
Page 205 Disinfection All the specifications listed below apply to CaviCide disinfectant. The time specifica- tions for the cleaning processes validated by Berlin Heart take into account an addi- tional application time of one minute. Please bear in mind that other disinfectants may require different application times. To ensure reliable disinfection, add an additional application time of one minute to the ap- plication time specified by the manufacturer.
Page 206: Caddy, Accessory Bag, And Stroller Board
Disinfection All the specifications listed below apply to CaviCide disinfectant. The time specifica- tions for the cleaning processes validated by Berlin Heart take into account an addi- tional application time of one minute. Please bear in mind that other disinfectants may require different application times. To ensure reliable disinfection, add an additional application time of one minute to the ap- plication time specified by the manufacturer.
Page 207: Panel Pc, Docking Station, Power Supply Units, Battery Charging Unit, Cable
Dry the surfaces with a cloth. Disinfection All the specifications listed below apply to CaviCide disinfectant. The time specifica- tions for the cleaning processes validated by Berlin Heart take into account an addi- tional application time of one minute. 1015002x03...
Page 208: Performing Functional Tests
Maintenance, Cleaning and Disinfection Please bear in mind that other disinfectants may require different application times. To ensure reliable disinfection, add an additional application time of one minute to the ap- plication time specified by the manufacturer. Moisten a cloth with disinfectant. Wipe down all external surfaces for 4 minutes.
Page 209: Overview Of Regular Activities
Maintenance, Cleaning and Disinfection 18.5 Overview of Regular Activities Fig. 18-1 Overview of regular activities When? What / where? Activity Every 4 hours Cannulae Check for deposits and defects Blood pump Check for deposits and defects Check for complete filling and emptying Driving unit Check if alarms have occurred Flow sensor...
Page 210 Maintenance, Cleaning and Disinfection When dressing Transcutaneous Cleaning and disinfection is changed: exit site Dressing change interval varies; see EXCOR Sterile Compo- Cannulae under Cleaning and disinfection nents instruc- the dressing Check for deposits and defects tions for use Flow sensor Cleaning and disinfection Weekly Contact and...
Page 211: Scope Of Delivery And Transport Cases
Scope of Delivery and Transport Cases Scope of Delivery and Transport Cases WARNING System components must only be transported or shipped in their in- tended transport cases / packaging. Otherwise, safe and proper trans- portation of the components is not guaranteed. 19.1 Contents of the Components Case Item Component...
Page 212: Contents Of Driving Unit Case
Scope of Delivery and Transport Cases 11 12 Fig. 19-1 Contents of the components case Pack the case for shipment as shown in the figure. 19.2 Contents of Driving Unit Case The driving unit case contains a driving unit, the batteries, and the manual pump. The specific model varies by approval region.
Page 213: Contents Of The Flow Sensor Set
Scope of Delivery and Transport Cases Pack the driving unit, the batteries, and the manual pump into the driving unit case as shown in the figure. 1 Manual pump 2 Driving unit 3 Battery 1 Pull-out handle 2 Grommet for sealing the case 3 Closure Fig.
Page 214 Scope of Delivery and Transport Cases Flow sensor set Quantity Cable wrap including wrapping tool 1505100 Accompanying documentation Flow sensor set 2 – FS09-09-P 1505010 Flow sensor FS09-09-P Replacement part set FS09 consisting 1505120 - Sensor quick connect FS09 - Sensor locking clip FS09 - Protective cap Cable wrap including wrapping tool 1505100...
Page 215: Optional Components
Scope of Delivery and Transport Cases Flow sensor set Quantity Cable wrap including wrapping tool 1505100 Accompanying documentation Flow sensor set 5 – FS12-12-P 1505030 Flow sensor FS12-12-P Replacement part set FS12 consisting 1505130 - Sensor quick connect FS12 - Sensor locking clip FS12 - Protective cap Cable wrap including wrapping tool 1505100...
Page 216: Replacement Part Sets For Flow Sensors
Scope of Delivery and Transport Cases Item Component Quantity Child seat fixture with accessories 1550203 Baby carrier fixture 1550202 Tab. 19-4 Optional Components 19.5 Replacement Part Sets for Flow Sensors Item Component Quantity Replacement part set FS06 1505110 Replacement part set FS09 1505120 Replacement part set FS12 1505130...
Page 217: Technical Data
Technical Data Technical Data 20.1 Driving Unit Parameter Value Weight Around 12 kg Weight with batteries Around 14.4 kg Dimensions (L x W x H) 326 mm x 218 mm x 398 mm Protection class (Protection against electric shock) Input voltage 19 V DC Power consumption 110 VA...
Page 218: Flow Sensor
Technical Data Nominal voltage 14.4 V DC 14.8 V DC Nominal capacity 6000 mAh Capacity 86.4 Wh 88.8 Wh Charging time max. 7 h in driving unit max. 3 h in battery charging unit Protection type, ingress pro- IP 53 (protected against dust and spraying tection water) Tab.
Page 219: Panel Pc And Docking Station
Technical Data 20.5 Panel PC and Docking Station Parameter Value Model MIT-W101 MIT-W102 Weight 1.2 kg Dimensions (L x W 295 mm x 199 mm x 23 mm x H) Input voltage 18 V DC 19 V DC Input current max.
Page 220: Battery Charging Unit
Technical Data Model MIT-W101 MIT-W102 Docking station Docking station Weight approx. 1.1 kg Dimensions (L x W 261 mm x 185 mm x 104 mm x H) Input voltage 18 V DC 19 V DC Input current 3.5 A 3.15 A Protection class Tab.
Page 221: Packaging
Technical Data Weight approx. 1.0 kg approx. 1.0 kg Dimensions 157 mm x 328 mm x 157 mm x 328 mm x (L x W x H) 346 mm 346 mm Weight 3.6 kg 3.6 kg 559 mm x 542 mm x 559 mm x 542 mm x Measurements 652 mm...
Page 222: Ambient Conditions
Technical Data 20.9 Ambient Conditions All specified air humidity values refer to non-condensing environmental conditions. 20.9.1 Operating Conditions The following operating conditions apply to the EXCOR Active. Components Temperature Air humidity Pressure Mobile: 1060 hPa 98 % 40 °C Driving unit includ- ing battery - 10 °C 15 %...
Page 223: Storage Conditions
Technical Data 20.9.2 Storage Conditions The following storage conditions apply to the EXCOR Active. The storage conditions are meant as conditions under which components are kept at the ready for immediate use. Temperature Air humidity Pressure 1060 hPa 90 % 40 °C 5 °C 600 hPa...
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Page 225: Overview - Parameters
Overview – Parameters Overview – Parameters Depending on the driving unit model (see Section 3.3: Scope of Driving Unit Function- ality, page 22) and the parameters selected, not all values will always be available for selection. Example: If a 10 ml blood pump has been selected, a 12 mm cannula can- not be selected.
Page 226: Permitted Combinations Of Blood Pumps And Cannulae
Overview – Parameters 21.3 Permitted Combinations of Blood Pumps and Cannulae Size of the blood pump Inflow cannula Outflow cannula [ml] [mm] [mm] 6 with connecting set 5 with connecting set 6 with connecting set 6 with connecting set 6 with connecting set 6 with connecting set 6 with connecting set 6 with connecting set...
Page 227: Use Of The External Alarm
Use of the External Alarm Use of the External Alarm 22.1 Assembling the Adapter for the External Alarm Before using the external alarm, the hospital must provide a connection. The required device connection plug is included in delivery and can be assembled by the hospital’s qualified personnel.
Page 228 Use of the External Alarm Conductor diameter 4.5 … 10 mm / 0.18... 0.39” Electrical data The contacts are deenergized. Rated voltage maximum 60 V Rated current maximum 3 A 1015002x03...
Page 229: Emc
If in doubt, contact Berlin Heart. 23.2 Essential Performance Characteristics The following essential performance characteristics were tested, and are also valid under the influence of electromagnetic interference: •...
Page 230: Electromagnetic Emissions
higher deviation of the measured flow, wherein the deviation shall have returned to the range of + 15 % / - 10 % no later than 5 s after the interference. • Synchronization does not deviate by more than ± 8 %. Even under the influence of electromagnetic interference, the following applies: •...
Page 231: Electromagnetic Immunity, Part 1
23.4 Electromagnetic Immunity, Part 1 Guidelines and manufacturer’s declaration – electromagnetic immunity The EXCOR Active is intended for use in an electromagnetic environment as described below. The customer or user of the EXCOR ACTIVE should ensure that the EXCOR Active is used in such an environment.
Page 232: Electromagnetic Immunity, Part 2
23.5 Electromagnetic Immunity, Part 2 Guidelines and manufacturer’s declaration – electromagnetic immunity The EXCOR Active is intended for use in an electromagnetic environment as described below. The customer or user of the EXCOR ACTIVE should ensure that the EXCOR Active is used in such an environment.
Page 233 Guidelines and manufacturer’s declaration – electromagnetic immunity The EXCOR Active is intended for use in an electromagnetic environment as described below. The customer or user of the EXCOR ACTIVE should ensure that the EXCOR Active is used in such an environment. Interference immu- IEC 60601 test Level of compli-...
Page 234 Guidelines and manufacturer’s declaration – electromagnetic immunity The EXCOR Active is intended for use in an electromagnetic environment as described below. The customer or user of the EXCOR ACTIVE should ensure that the EXCOR Active is used in such an environment. Interference immu- IEC 60601 test Level of compli-...
Page 235 Guidelines and manufacturer’s declaration – RFID magnetic fields Interference immu- Test level Level of compli- Electromagnetic nity tests ance environment – Guide- lines Immunity to RFID 134.2 kHz 65 A/m 134.2 kHz 65 A/m If you are using an RFID magnetic fields device in the immediate 13.56 MHz 7.5 A/m...
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Page 237: Patient Id Labels
Patient ID Labels Patient ID Labels Configured replacement driving units must be labeled so that each replacement driv- ing unit can be unambiguously associated with a patient. There is a tray for the patient ID card on the rear side of the driving unit. If the original tray is already in use, you can copy this label template and use it instead.
Page 238 Patient ID Labels 1015002x03...
Page 239: Abbreviations
Abbreviations Abbreviations BVAD: Biventricular Assist Device CF: Cardiac Floating – Electrically connected applied parts suitable for direct contact with the heart or for intrave- nous use are classified according to type CF. CISPR: Special International Committee on Radio Interference (comité international spécial des perturbations ra- dioélectriques) CPB: Cardiopulmonary bypass EMC: Electromagnetic Compatibility...
Page 240 Abbreviations 1015002x03...
Page 241 Print Control A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Ä Ö Ü a b c d e f g h i m n o p q r u v w x y z ß...
Page 242 1015002x03...

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