Maquet CARDIOHELP System Instructions For Use Manual
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Maquet CARDIOHELP System Instructions For Use Manual

Maquet CARDIOHELP System Instructions For Use Manual

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INSTRUCTIONS FOR USE
CARDIOHELP System

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  • Page 1 INSTRUCTIONS FOR USE CARDIOHELP System...
  • Page 2 All rights reserved. No part of this publication may be duplicated, adapted or translated without prior written permission, except under the terms of the copyright laws. © Copyright Maquet Cardiopulmonary GmbH Subject to technical changes Owing to our policy of continuous product development, the illustrations and technical data contained in this document may differ slightly from the current version of the device.

  • Page 3: Table Of Contents

    | CARDIOHELP System | Contents | 3 | Contents General ........................10 Information on these Instructions for Use ............10 1.1.1 Symbols ....................10 1.1.2 Definitions ....................10 Environmental Protection..................11 1.2.1 Packaging ....................11 1.2.2 Batteries ....................11 1.2.3 Disposal ....................11 Abbreviations ....................11 Safety .........................13 Intended Purpose .....................13 2.1.1...
  • Page 4 | 4 | Contents | CARDIOHELP System | 3.2.1 Connectors...................33 3.2.2 Controls....................34 Control Panel ....................35 3.3.1 LED Speed Indicator ................35 3.3.2 Keypad ....................35 3.3.3 Rotary Knob ..................38 3.3.4 Touchscreen ..................38 Sensors......................38 3.4.1 Flow/Bubble Sensor ................38 3.4.2 Bubble Sensor..................38 3.4.3 Venous Probe ..................39 3.4.4...
  • Page 5 | CARDIOHELP System | Contents | 5 | 3.13.5 Using a Selection List................57 System Preparation ....................58 Installing the Holder ..................58 4.1.1 Holder for CARDIOHELP-i ..............58 Installing Accessories for Intra-hospital Patient Transport........58 4.2.1 Securing the Disposable with the Transport Guard for CARDIOHELP Disposables..................59...
  • Page 6 | 6 | Contents | CARDIOHELP System | 4.10.3 Save Hospital Configuration..............83 4.10.4 Calibrate Touchscreen .................84 4.10.5 Calibrating the Batteries...............85 4.11 User Functions....................90 4.11.1 Switching thApp ...................90 4.11.2 Activating LPM/RPM Mode ..............92 4.11.3 "Global Override" Mode ...............95 4.11.4 Data Recording ..................96 Preparing Application ....................101...
  • Page 7 | CARDIOHELP System | Contents | 7 | Defining Monitoring Settings ................126 6.2.1 Flow Monitoring..................127 6.2.2 LPM Mode: Speed Monitoring..............129 6.2.3 Pressure Monitoring ................130 6.2.4 Bubble Monitoring ................133 6.2.5 Pressure Drop Monitoring ..............136 6.2.6 Temperature Monitoring...............137 6.2.7 Blood Parameter Monitoring ..............138 User Modes and User Functions ..............139...
  • Page 8 | 8 | Contents | CARDIOHELP System | Cleaning and Disinfection ...................184 10.1 Surface Cleaning and Disinfecting After Each Use ..........184 10.1.1 Surface Cleaning..................184 10.1.2 Surface Disinfection ................184 10.2 Clean the Venous Probe...................184 Maintenance .......................187 11.1 Maintenance by the Operator ................187 11.1.1 Calibrating the Batteries...............187...
  • Page 9 | CARDIOHELP System | Contents | 9 | 14.8 Measured Data and Displayed Data ..............201 14.8.1 Flow......................202 14.8.2 Pressure....................202 14.8.3 Temperature..................202 14.9 Components Supplied ..................203 14.10 Possible Settings and Factory Settings ............203 14.10.1Speed/Flow ..................203 14.10.2Warning Limits, Alarm Limits and Interventions ........203 14.10.3General Settings ..................205...

  • Page 10: General

    | 10 | 1 General | CARDIOHELP System | 1 General 1.1 Information on these Instructions for Use These Instructions for Use will familiarize you with the features of the device. 1.1.1 Symbols References References to other pages in these Instructions for Use begin with the arrow sign "⇨".

  • Page 11: Environmental Protection

    1.2 Environmental Protection 1.2.1 Packaging All packaging materials are made of environmentally safe materials. On request, Maquet will be happy to dispose of the packaging materials. 1.2.2 Batteries Batteries can be disposed of via the local recycling center. 1.2.3 Disposal...
  • Page 12 | 12 | 1 General | CARDIOHELP System | Venous oxygen saturation thApp Therapy application WARNING! Only use thApp “Cardiopulmonary Support”. The thApp “Circulatory Support”, “Pulmonary Support”, and “CO Removal” are not to be used with the current indications for use as there is not sufficient data to support the safety and effectiveness of these applications with the CARDIOHELP System.

  • Page 13: Safety

    2.1 Intended Purpose 2.1.1 Indications for Use The CARDIOHELP System are devices that use a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: Partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during...
  • Page 14 The system must be monitored and operated by qualified medical staff trained in cardiopulmonary bypass (⇨ "Intended User", page 13). ‒ Patients who are supported by the CARDIOHELP System must be continuously monitored by a monitoring system and qualified medical staff. ‒...

  • Page 15: Position Of Use And Operation And Positioning Of The Cardiohelp-I15

    | CARDIOHELP System | 2 Safety | 15 | WARNING! During surgical use of the CARDIOHELP-i, the medical personnel must always be able to resuscitate and intubate the patient. Given the risk of negative pressure in the venous vascular system, all artificial venous vascular accesses (e.g., catheters and cannulae) must be protected...

  • Page 16: Handling The Cardiohelp-I

    | 16 | 2 Safety | CARDIOHELP System | WARNING! The use of this device directly next to other devices or stacked with other devices should be avoided since this could result in malfunction. If use as described above is nonetheless necessary, this device and the other devices should be observed to ensure that they are working properly.

  • Page 17: General Precautionary Measures During Use

    Maintenance work and repairs on the device and changes or modifications to it may only be performed by service personnel authorized by Maquet Cardiopulmonary. In order to ensure the safe use of the device, it is imperative that regular inspections are carried out.
  • Page 18 | 18 | 2 Safety | CARDIOHELP System | Only use the CARDIOHELP-i with a valve or other adequate systems or methods (e.g., tube clamp) which prevent a backflow. WARNING! If the pump stops or the backflow prevention or the zero flow mode is activated during an application, the blood flow will be interrupted and supply to the patient will cease.

  • Page 19: Monitoring And Sensors

    | CARDIOHELP System | 2 Safety | 19 | If the pump is running, only clamp the tube leading away from the patient (venous side) if the tube leading to the patient (arterial side) has already been clamped. If the flow stops during application, the heat of the motor can be transferred to the blood in the pump.
  • Page 20 | 20 | 2 Safety | CARDIOHELP System | Flow monitoring WARNING! Only use the CARDIOHELP-i with flow monitoring which triggers an alarm. Pressure monitoring WARNING! Only use the CARDIOHELP-i with activated pressure monitoring which triggers an alarm and, if necessary, an intervention.
  • Page 21 Using contrast agents with microbubbles can lead to venous air embolism or arterial air embolism via veno-arterial shunt in the patient. Using contrast agents with microbubbles can lead to arterial air embolism during veno-arterial application of the CARDIOHELP System. Blood Gas Values WARNING! Please note the possible failure of the venous probe.

  • Page 22: Extended Applications

    (⇨ "Flow Off-Set Calibration of the Flow/Bubble Sensor", page 117). 2.3 Intra-hospital Patient Transport The CARDIOHELP System can be used for intra-hospital patient transport. Intra-hospital patient transport is conveyance of the patient within the hospital, which does not involve leaving the surgical environment (e.g. transport from catheter laboratory to operating room).
  • Page 23 CARDIOHELP-i out of service after use, and have the CARDIOHELP-i checked by authorized service personnel. WARNING! The entire CARDIOHELP System can tolerate ESD pulses of up to ± 15 kV. The controls (touchscreen, rotary knob, buttons) can withstand ESD impulses up to ± 15 kV.

  • Page 24: Electromagnetic Compatibility

    2 Safety | CARDIOHELP System | 2.4 Electromagnetic Compatibility The CARDIOHELP System complies with the requirements of the IEC 60601-1-2 standard on electromagnetic compatibility. The system and all accessories and sensors meet the EMC requirements of a surgical environment (⇨...

  • Page 25: Symbols

    | CARDIOHELP System | 2 Safety | 25 | Only use RPM mode for intra-hospital patient transport. In LPM mode, the pump control can be impaired by incorrect flow values. Please note that flow values may be displayed with reduced accuracy.
  • Page 26 | 26 | 2 Safety | CARDIOHELP System | The device meets Canadian and American safety standards. Tested by the Nationally Recognized Test Laboratory SGS North America, Inc. 710165 Protection type in accordance with IEC 60529: Protection against vertically dripping wa- Protection type in accordance with IEC 60529: Protection against splashing water from...
  • Page 27 | CARDIOHELP System | 2 Safety | 27 | Front connections "Alarm outlet" connection Not fail-safe as defined by the IEC 60606-1-8 standard ⇨ "Connecting an External Alarm System", page 69 Ethernet connection Not used "Emergency mode" button ⇨ "Using the Emergency Mode", page 147 USB port ⇨...

  • Page 28: Rating Plate

    | 28 | 2 Safety | CARDIOHELP System | Connection for clamp Not used Connection for bubble ⇨ "Connecting the Venous Bubble Sensor", page 107 sensor Connection for venous ⇨ "Connecting the Venous Probe", page 70 probe Connection for level sensor Note: Level monitoring only in thApp „MECC“.

  • Page 29: System Description

    3 System Description 3.1 System Definition 3.1.1 CARDIOHELP System The CARDIOHELP System is a compact perfusion system with which cardiopulmonary bypass can be driven, controlled, monitored and recorded. The CARDIOHELP System consists of the following components: CARDIOHELP-i device (CARDIOHELP Device)

  • Page 30: Activatable Modes

    | 30 | 3 System Description | CARDIOHELP System | thApps Car- Circula- MECC Pul- diopul- tory sup- monary moval monary port support support Δ Screens: "Transport" screen Parameter list Other functions: Night mode Deactivate automatic locking 3.1.3 Activatable Modes...

  • Page 31: System Modes

    | CARDIOHELP System | 3 System Description | 31 | Zero flow mode In the zero flow mode, the CARDIOHELP-i aims at a flow of 0 l/min by controlling the pump accordingly. In this way, both forward and backward flow can be prevented.

  • Page 32: Data Recording

    | 32 | 3 System Description | CARDIOHELP System | 3.1.5 Data Recording The CARDIOHELP-i can make data available for online recording or save it offline: Online recording Online recording continuously makes data available at the Type B USB port.

  • Page 33: Connectors

    | CARDIOHELP System | 3 System Description | 33 | 15 Rating plate 16 Security seal 17 Pump drive ventilation opening 18 Sled for mobile holder HKH 8860 3.2.1 Connectors Front connections "Alarm outlet" connection Ethernet connection (cannot be used)

  • Page 34: Controls

    | 34 | 3 System Description | CARDIOHELP System | 3.2.2 Controls Safety bar "Emergency mode" release mechanism (CAR- DIOHELP Emergency Drive) Holder for venous probe "Disposable" release mechanism Holder for "disposable" connection cable "Safety bar" release mechanism Safety bar The safety bar protects the CARDIOHELP-i and the attached disposable.

  • Page 35: Control Panel

    | CARDIOHELP System | 3 System Description | 35 | 3.3 Control Panel LED speed indicator Keypad Rotary knob Touchscreen 3.3.1 LED Speed Indicator The speed indicator LED on the top of the CARDIOHELP-i displays the speed independently of the touchscreen. Use the values of the LED speed indicator in emergency mode (⇨...
  • Page 36 | 36 | 3 System Description | CARDIOHELP System | "Battery" and "AC/DC power supply" LEDs The "Battery" and "AC/DC power supply" LEDs display the status of the battery and the power supply, independently of the touchscreen. Element Meaning "Battery" LED LED illuminated: Battery is being charged.
  • Page 37 | CARDIOHELP System | 3 System Description | 37 | "Lock/Unlock" LED and Button The controls (rotary knob, buttons and touchscreen) are locked automatically after 3 minutes of inactivity. This prevents settings being inadvertently altered or functions inadvertently called up. WARNING! The thApp “MECC”...

  • Page 38: Rotary Knob

    | 38 | 3 System Description | CARDIOHELP System | 3.3.3 Rotary Knob The rotary knob enables you to change the setpoint speed or the setpoint flow (⇨ "RPM mode: changing the speed", page 93 and ⇨ "LPM mode: changing the flow", page 95).

  • Page 39: Venous Probe

    | CARDIOHELP System | 3 System Description | 39 | WARNING! Do not open the rear of the bubble sensor. This damages the sensor and it can no longer be used. 3.4.3 Venous Probe Optical sensors Connection for venous probe sensor cable The venous probe of the CARDIOHELP-i measures the venous blood parameters , Hb, Hct and temperature.

  • Page 40: Pressure Sensor

    The transport guard secures a HLS Set Advanced. Cardiohelp Mobile Holder HKH 8860 The mobile holder serves as a support for the CARDIOHELP System and the connected disposable. It can be attached to a stretcher with two lockable hooks. A telescopic infusion pole for bags or bottles is optionally available.

  • Page 41: System Components

    | CARDIOHELP System | 3 System Description | 41 | 3.6.1 System Components Lock Fixing hooks for CARDIOHELP-i Transport Guard for CARDIOHELP Disposables Attachment point for stretcher Infusion pole (optional) Attachment point for CARDIOHELP-i Cardiohelp Mobile Holder HKH 8860 3.7 User Interface...

  • Page 42: Status Bar

    | 42 | 3 System Description | CARDIOHELP System | 3.7.1 Status Bar The top of the touchscreen displays the status bar with the following information: Current thApp (⇨ "thApp-specific Parameters and Functions", page 29) Alarm signal (only for alarm) "Lock"...

  • Page 43: Toolbar

    | CARDIOHELP System | 3 System Description | 43 | 3.7.2 Toolbar The touchscreen displays the toolbar on the right. This allows you to navigate between different screens, call up functions, as well as activate and deactivate settings. Symbol Meaning "Startup screen"...

  • Page 44: Parameter Display

    | 44 | 3 System Description | CARDIOHELP System | Symbol Meaning "Startup screen" Switch to startup screen (⇨ "Startup Screen", page 48) "Parameter list" Switch to parameter list (⇨ "Parameter List", page 53) "Blood parame- Switch to "Blood parameters" screen (⇨ ""Blood Parameters"...
  • Page 45 | CARDIOHELP System | 3 System Description | 45 | Values displayed WARNING! Check the pressure values for plausibility. Implausible pressures of -500 mmHg, 0 mmHg and "outside of measuring range" can occur due to a malfunction or a short circuit of the cable.
  • Page 46 | 46 | 3 System Description | CARDIOHELP System | Parameter Description Temperatures: Venous Disposables with integrated sensors: Disposables with venous mea- temperature suring cell. Disposables without integrated sensors: Temperature at external ve- nous temperature sensor. Arterial Disposables with integrated sensors: Temperature at blood outlet.
  • Page 47 | CARDIOHELP System | 3 System Description | 47 | Example: Symbol Meaning Parameter symbol No alarm situation, the intervention for the parameter is deactivated. Additional symbol Intervention for the parameter is activated. "Intervention acti- vated" Red parameter High-priority alarm: The status bar displays a message (⇨ "Physio- symbol logical Alarms", page 158).

  • Page 48: Startup Screen

    | 48 | 3 System Description | CARDIOHELP System | Display Meaning LPM in white figures on LPM mode active, the actual flow is displayed. blue background LPM in light-blue figures LPM mode active, the currently desired flow set- on blue background point is displayed (⇨...

  • Page 49: Menu Screen

    | CARDIOHELP System | 3 System Description | 49 | 3.9 Menu Screen In the menu, the touchscreen displays symbols with which you can select further functions. To switch to the menu, touch the "Menu" symbol. Symbol Meaning "Settings" Changing general settings (⇨ "General Settings", page 50).

  • Page 50: General Settings

    | 50 | 3 System Description | CARDIOHELP System | 3.9.1 General Settings To set the general settings, touch the [Settings] symbol in the "Menu" screen. ▶ The "General settings" screen opens. Function Meaning System Informa- ⇨ "Displaying System Information", page 79...

  • Page 51: Emergency Mode

    | CARDIOHELP System | 3 System Description | 51 | NOTE When you switch thApp, the alarm pause for current acoustic alarms ends (⇨ "Switching thApp", page 90). When alarms are paused, the alarm is only displayed optically. The acoustic alarm pause lasts for a maximum of one minute.

  • Page 52: Functioning Of Individual Controls In Emergency Mode

    | 52 | 3 System Description | CARDIOHELP System | WARNING! All of the alarms and interventions are deactivated in emergency mode. There is a risk of dangerous situations not being recognized and endangering the patient. When the locking of the controls is deactivated, there is a risk that settings may be inadvertently changed, resulting in an unsuitable setpoint speed being set.

  • Page 53: Screens In The Tab Bar

    | CARDIOHELP System | 3 System Description | 53 | 3.12 Screens in the Tab Bar 3.12.1 Parameter List In this screen, the touchscreen displays the pressure and temperature parameters as well as the pressure drop. To switch to this screen, tap the "Parameter list" symbol.

  • Page 54: Transport" Screen

    | 54 | 3 System Description | CARDIOHELP System | thApp "Cardiopulmonary support" thApp "MECC" NOTE Do not use thApp “Circulatory support”, thApp “Pulmonary support”, thApp “CO removal”, or thApp “MECC”. 3.12.3 "Transport" Screen In this screen, the touchscreen displays parameters in large digits.

  • Page 55: Timer Screen

    | CARDIOHELP System | 3 System Description | 55 | In this screen, the touchscreen displays different parameters, depending on the thApp. Consult the table in chapter ⇨ "thApp-specific Parameters and Functions", page 29 for further information. thApp "Cardiopulmonary support"...

  • Page 56: Basic Handling Information For Software

    | 56 | 3 System Description | CARDIOHELP System | Once the countdown time has elapsed, the countdown timer issues a low-priority alarm. The symbol turns yellow. The status bar shows the following message: [Countdown time elapsed]. When the maximum runtime of the timers 1 to 3 has elapsed, the timer stops and is reset to 0.

  • Page 57: Using A Selection List

    | CARDIOHELP System | 3 System Description | 57 | With the "Speed" symbol, you can adjust the speed setpoint by touching the symbol. (⇨ "RPM mode: changing the speed", page 93). 3.13.5 Using a Selection List The touchscreen displays selection lists in which you can select a value using the arrow buttons or by touch- ing directly.

  • Page 58: System Preparation

    | 58 | 4 System Preparation | CARDIOHELP System | 4 System Preparation 4.1 Installing the Holder 4.1.1 Holder for CARDIOHELP-i WARNING! Please note the requirements regarding position of use and operation and positioning (⇨ "Position of Use and Operation and Positioning of the CARDIOHELP-i", page 15).

  • Page 59: Securing The Disposable With The Transport Guard For Cardiohelp Disposables

    | CARDIOHELP System | 4 System Preparation | 59 | 4.2.1 Securing the Disposable with the Transport Guard for CARDIOHELP Disposables The disposable can come loose from the CARDIOHELP-i due to strong mechanical forces. Use the SPRINTER CART or SPRINTER CART XL for intra- hospital patient transport.

  • Page 60: Attaching The Cardiohelp To The Mobile Holder Hkh 8860

    | 60 | 4 System Preparation | CARDIOHELP System | Make sure that both fixing hooks are properly attached and the lock is securely closed. Removing the Transport Guard for CARDIOHELP Disposables Open the fastener of the Transport Guard for CARDIOHELP Disposables and remove the fixing hooks from the openings.

  • Page 61: Attaching And Adjusting The Infusion Mast (Optional)

    | CARDIOHELP System | 4 System Preparation | 61 | Ensure that the sled on the underside of the CARDIOHELP-i slides into the retainer [2]. Lock the CARDIOHELP-i: Set the locking lever to the [Locked] symbol [3]. Ensure that the locking device has correctly clicked into place and that the CARDIOHELP-i is securely fixed.

  • Page 62: Attaching The Mobile Holder To A Stretcher

    | 62 | 4 System Preparation | CARDIOHELP System | Set the upper part of the mast to the desired height and release the plastic ring. Make sure that the upper part of the mast has engaged. 4.2.4 Attaching the Mobile Holder to a Stretcher You can attach the mobile holder to a stretcher using the two lockable hooks.

  • Page 63: Positioning The Cardiohelp Emergency Drive

    | CARDIOHELP System | 4 System Preparation | 63 | Press on the locking button, to close the lock again. ▶ The hook is locked. Make sure that both hooks are properly attached to the stretcher and securely locked. 4.3 Positioning the CARDIOHELP Emergency Drive 4.3.1 Fitting the CARDIOHELP Emergency Drive Holder...

  • Page 64: Fitting The Cardiohelp Emergency Drive

    | 64 | 4 System Preparation | CARDIOHELP System | To detach the holder, follow the same procedure in reverse order. Holder for mast HKH 9101-M Undo the wing bolt [1] on the mast retainer [2]. Position the holder so that the mast fits into the mast retainer and tighten the wing bolt.

  • Page 65: Setting Up And Connecting The Cardiohelp-I

    | CARDIOHELP System | 4 System Preparation | 65 | Insert the CARDIOHELP Emergency Drive into the coupling on the holder or on the CARDIOHELP-i. Holder for CARDIOHELP Emergency Drive HKH 9101-R or HKH 9101-M: Coupling for CARDIOHELP Emer- gency Drive Coupling release mechanism Ensure that the coupling clicks properly into place.
  • Page 66 | 66 | 4 System Preparation | CARDIOHELP System | Ensure that the sled on the underside of the CARDIOHELP-i slides into the retainer [2]. Lock the CARDIOHELP-i: Set the locking lever to the [Locked] symbol [3]. Ensure that the locking device has correctly clicked into place and that the CARDIOHELP-i is securely fixed.

  • Page 67: Opening The Safety Bar

    | CARDIOHELP System | 4 System Preparation | 67 | NOTE Equipotential bonding conductor When the CARDIOHELP-i is connected to an external power supply, ensure that the protective ground equipotential bonding is assured and the equipotential bonding conductor is connected.

  • Page 68: Connecting The Sensors

    If you are using the CARDIOHELP-i together with other medical devices, check the total leakage currents. Only connect the device to interfaces that are specified by Maquet. Ensure that devices which are connected to the digital interface of the CARDIOHELP-i fulfill the following specifications: ‒...

  • Page 69: Connecting A Data Recording System

    | CARDIOHELP System | 4 System Preparation | 69 | Only use the type B USB port to connect an external data recording system for recording data online. Not all data displayed by the CARDIOHELP-i will be transferred to the external data recording system. Therefore, do not rely on the recorded data to make treatment decisions.

  • Page 70: Connecting The Venous Probe

    | 70 | 4 System Preparation | CARDIOHELP System | NOTE In order to connect an external alarm system, the operator must use a specially adapted cable (plug type RJ22, max. line voltage 40 V, max. rated capacity 500 mAh). You can connect an external alarm system to monitor and transmit alarms.

  • Page 71: Switching On The Cardiohelp-I, Self-Test

    | CARDIOHELP System | 4 System Preparation | 71 | Fix the venous probe in its holder on the safety bar of the CARDIOHELP-i. Ensure that the venous probe has clicked into place. 4.7 Switching on the CARDIOHELP-i, Self-Test WARNING!

  • Page 72: Display Following Successful Self-Test

    | 72 | 4 System Preparation | CARDIOHELP System | Check that the speaker and warning buzzer generate acoustic signals. ▶ The CARDIOHELP-i will automatically perform a self-test after being switched on. ▶ The CARDIOHELP-i initializes the venous probe against the black reference surface on its holder.

  • Page 73: System Configuration

    | CARDIOHELP System | 4 System Preparation | 73 | Touch the symbol [Confirm] to close the failure report. Carry out the actions suggested in the relevant chapter (⇨ "Self-Test Failure Report", page 183). Take the CARDIOHELP-i out of service and have it tested by the authorized service personnel.

  • Page 74: Changing And Testing The Brightness/Volume

    | 74 | 4 System Preparation | CARDIOHELP System | To accept the changes, touch the [Confirm] symbol. To reject the changes, tap the [Reject] symbol. AutoLock sym- Meaning Deactivated The controls are not locked automatically. To activate the automatic lock, touch the symbol.

  • Page 75: Activating Night Mode

    | CARDIOHELP System | 4 System Preparation | 75 | Testing the speaker/warning buzzer To test the speaker and warning buzzer, touch the [Test speaker] symbol. ▶ The speaker and alarm buzzer of the CARDIOHELP-i generate acoustic signals with which the function and volume can be checked.

  • Page 76: Changing The Display Language

    | 76 | 4 System Preparation | CARDIOHELP System | NOTE If night mode is active and you switch to thApp "MECC", night mode is deactivated automatically. If you return to another thApp, night mode remains deactivated. 4.8.4 Changing the Display Language...
  • Page 77 | CARDIOHELP System | 4 System Preparation | 77 | Change time Touch the [Settings] symbol in the menu. Touch [Time/date] in the "Settings" screen. To change the current time, touch the button under the [Time] symbol. ▶ The touchscreen displays the [Time] screen.
  • Page 78 | 78 | 4 System Preparation | CARDIOHELP System | ▶ The touchscreen displays the [Date] screen. In this example the format DD.MM.YYYY. Set the current date. To do this, touch the fields and adjust the values. To accept the changes, touch the [Confirm] symbol.

  • Page 79: System Information

    | CARDIOHELP System | 4 System Preparation | 79 | To accept the changes, touch the [Confirm] symbol. To reject the changes, touch the [Reject] symbol. ▶ The touchscreen shows the [Time/date] screen again. To close the screen, touch the [Confirm] symbol.
  • Page 80 | 80 | 4 System Preparation | CARDIOHELP System | ▶ "Battery" window during battery operation. Charging and power supply status (not visible) Battery compartment 1 (corresponds to label on battery compartment) Battery compartment 2 (corresponds to label on battery compartment)

  • Page 81: Key User Functions

    | CARDIOHELP System | 4 System Preparation | 81 | Battery status Meaning Remaining capacity Approximate remaining capacity. Calibration required ⇨ "Calibrating the Batteries", page 85 Battery not detected Have CARDIOHELP-i checked by authorized service per- sonnel. 4.10 Key User Functions...
  • Page 82 | 82 | 4 System Preparation | CARDIOHELP System | ▶ The touchscreen displays a virtual keyboard: Input field Switch between upper and lower case Example: Button for the characters 6, K and L Selection window with the three char-...

  • Page 83: Define The Alarm Configuration

    | CARDIOHELP System | 4 System Preparation | 83 | 4.10.2 Define the Alarm Configuration With this function you can define whether the CARDIOHELP-i generates reminder signals. If the reminder signal is disabled, the user is not reminded acoustically that the "Global Override" or the emergency mode is active, for example.

  • Page 84: Calibrate Touchscreen

    | 84 | 4 System Preparation | CARDIOHELP System | NOTE Clinic configuration The following settings are part of the clinic configuration: Deactivation of the automatic lock (⇨ "thApp "MECC": Deactivate Automatic Locking", page 73) Language (⇨ "Changing the Display Language", page 76) Recording interval (⇨...

  • Page 85: Calibrating The Batteries

    | CARDIOHELP System | 4 System Preparation | 85 | Call up the "Service" screen (⇨ "Calling Up the "Service" Screen", page 81). In the "Service" screen, touch [Calibration]. Touch [Touchscreen calibration]. If the touchscreen is wrongly calibrated, you may not be able to access the "Service"...
  • Page 86 The calibration cycles are performed automatically and are displayed below "Cycle". The first number shows the current cycle of the CARDIOHELP System. The second number shows the maximum number of calibration cycles. In the case of two or more cycles, only the last cycle is concluded with step 3. If more than 3 cycles are necessary, the batteries must be replaced.
  • Page 87 | CARDIOHELP System | 4 System Preparation | 87 | Battery Calibration Unit (optional) The time required for calibration can be significantly reduced with the Battery Calibration Unit. This cuts the time needed for discharging by about three quarters. The Battery Calibration Unit has no effect on discharging or remaining battery life except during calibration.
  • Page 88 | 88 | 4 System Preparation | CARDIOHELP System | Call up the "Service" screen (⇨ "Calling Up the "Service" Screen", page 81). In the "Service" screen, touch [Calibration]. Touch [Battery calibration]. ▶ The CARDIOHELP-i shows the following message: [Battery calibration takes several hours.
  • Page 89 | CARDIOHELP System | 4 System Preparation | 89 | WARNING! Charge level after calibration is completed If you confirm calibration prematurely (battery charge status approx. 40%), the batteries are not fully charged. Connect the CARDIOHELP-i to the external power supply.

  • Page 90: User Functions

    | 90 | 4 System Preparation | CARDIOHELP System | To close the "Battery calibration" window, touch the [Reject] symbol. Start calibration again (⇨ "Calibrating", page 87). If calibration fails again, have the batteries replaced by authorized service personnel. WARNING!
  • Page 91 | CARDIOHELP System | 4 System Preparation | 91 | WARNING! Ensure that the selected thApp is suitable and safe for the patient and the current situation. If you switch to another thApp, only the warning and alarm limits and interventions that are available in the new thApp are applied.

  • Page 92: Activating Lpm/Rpm Mode

    | 92 | 4 System Preparation | CARDIOHELP System | NOTE In order not to change the thApp, you can abort the procedure at any time with [Reject] symbol. Touch the "thApp" symbol in the menu. Touch the symbol of the desired thApp.
  • Page 93 | CARDIOHELP System | 4 System Preparation | 93 | NOTE When changing from LPM to RPM, an RPM intervention, if set, is deactivated. When changing again to LPM mode, the intervention is still deactivated and must be activated again manually.
  • Page 94 | 94 | 4 System Preparation | CARDIOHELP System | You can change the setpoint value using the touchscreen or the rotary knob. Change using the rotary knob To change the setpoint value, turn the rotary knob. ▶ The touchscreen displays the specified setpoint value in gray and switches back to display the measured value after 2 seconds.

  • Page 95: Global Override" Mode

    | CARDIOHELP System | 4 System Preparation | 95 | LPM mode: changing the flow In LPM mode, the setpoint flow can be changed in all screens. The value of the flow parameter is shown on a blue background. The touchscreen displays the currently measured value.

  • Page 96: Data Recording

    | 96 | 4 System Preparation | CARDIOHELP System | NOTE Deactivated reminder signal and "Global Override" Authorized persons can specify in the alarm configuration whether the CARDIOHELP-i is to generate reminder signals. If the reminder signal is not activated, you will not be acoustically reminded that the CARDIOHELP-i is in "Global Override"...
  • Page 97 | CARDIOHELP System | 4 System Preparation | 97 | The touchscreen displays the following window: Interval Offline recording Export data You have the following options: Change the interval for data recording. Record data offline. Export recorded data. Change the interval for data recording This function changes the interval for data recording.
  • Page 98 | 98 | 4 System Preparation | CARDIOHELP System | ▶ If the capacity of the internal memory has been reached, the CARDIOHELP-i stops the recording and displays the following message: [Internal memory full – Offline recording stopped]. To close the...
  • Page 99 | CARDIOHELP System | 4 System Preparation | 99 | NOTICE! If the USB stick already contains a file of the same name, it will be overwritten. NOTE No switching of the thApp during USB export During the USB export, the thApp cannot be changed (⇨ "Switching thApp", page 90).
  • Page 100 | CARDIOHELP System | NOTE Converting a chp file The Maquet CSV converter for converting the exported chp file is provided on the USB memory stick supplied. You will also find the Instructions for Use as a pdf file on the USB stick.

  • Page 101: Preparing Application

    | 101 | 5 Preparing Application 5.1 Application Overview for Disposables Various disposables are available from Maquet Cardiopulmonary for the CARDIOHELP-i. They are tailored for different fields of application, and differ in their integrated sensors, among other things. Pump drive...
  • Page 102 | 102 | 5 Preparing Application | CARDIOHELP System | Do not route connecting cables or tubes over the safety bar or though the lower protective frame. This ensures you will be able to switch the disposable over to the emergency drive quickly in an emergency (⇨ "Using the Emergency Drive with the Disposable HLS Retainer", page 148).

  • Page 103: Connecting The Integrated Sensors Of The Disposable

    | CARDIOHELP System | 5 Preparing Application | 103 | 5.2.2 Connecting the Integrated Sensors of the Disposable NOTE Only for disposables with integrated sensors The connecting cable can only be connected to disposables with integrated sensors. WARNING! Only use the disposable connecting cable listed as an accessory and which is suitable for the disposable used (⇨...
  • Page 104 | 104 | 5 Preparing Application | CARDIOHELP System | For measurement, the probe is connected to the disposable's measuring cell. The measuring cell is integrated in the oxygenator pump unit (HLS Set Advanced). NOTE Set breaking point of the integrated measuring cell...

  • Page 105: Connecting The Sensors

    | CARDIOHELP System | 5 Preparing Application | 105 | Press the release mechanism fold the safety bar down. Ensure that both release mechanisms of the safety bar click into place. Ensure that the measuring cell is recognized correctly (⇨ "Checking the Status of the Venous Probe and Measuring Cell", page 112).

  • Page 106: Connecting The Combined Arterial Flow/Bubble Sensor

    | 106 | 5 Preparing Application | CARDIOHELP System | You can also connect a sensor while the device is in operation. The CARDIOHELP-i recognizes it automatically. If you disconnect a sensor from the CARDIOHELP-i while it is operating, the CARDIOHELP-i generates an alarm and deactivates the interventions of the relevant parameter if necessary.

  • Page 107: Connecting The Venous Bubble Sensor

    | CARDIOHELP System | 5 Preparing Application | 107 | Press on the locking device [3] and open the cover [1]. Secure the flow/bubble sensor so that the tube fits into the retainer [2] and the arrows on the flow/bubble sensor point in the direction of flow.
  • Page 108 | 108 | 5 Preparing Application | CARDIOHELP System | Prior to operation, ensure that the tube is inserted correctly and that the locking device of the bubble sensor has clicked into place. Otherwise bubbles are not recognized and there is a risk of potentially fatal air embolisms.

  • Page 109: Connecting External Temperature Sensors

    | CARDIOHELP System | 5 Preparing Application | 109 | Close the cover so that the locking device clicks into place. Connect the sensor to the "Bubble sensor" interface [4]. Ensure that the cover and the locking device are closed properly and the tube is fixed securely.

  • Page 110: Connecting External Pressure Sensors

    | 110 | 5 Preparing Application | CARDIOHELP System | 5.3.4 Connecting External Pressure Sensors WARNING! It is the user's responsibility to position the connected sensors at suitable places in the system. Only use the sensors listed as accessories (⇨ "Accessories", page 194).

  • Page 111: Function Test

    | CARDIOHELP System | 5 Preparing Application | 111 | 5.4 Function Test 5.4.1 Switching on the CARDIOHELP-i, Self-Test WARNING! Attaching the venous probe to the holder The holder on the safety bar of the CARDIOHELP-i contains a black reference surface against which the venous probe can be initialized.

  • Page 112: Checking The Status Of The Venous Probe And Measuring Cell

    | 112 | 5 Preparing Application | CARDIOHELP System | Check that initialization of the venous probe was successful ⇨ "Checking the Status of the Venous Probe and Measuring Cell", page 112. ▶ The touchscreen displays the startup screen (⇨ "Display Following Successful Self-Test", page 72).
  • Page 113 | CARDIOHELP System | 5 Preparing Application | 113 | Check that the venous probe is [Initialized successfully]. If the venous probe could not be initialized, carry out initialization of the venous probe again (⇨ "Initializing the Venous Probe", page 114).

  • Page 114: Initializing The Venous Probe

    | 114 | 5 Preparing Application | CARDIOHELP System | Probe status Message Meaning Task Initialization suc- Venous probe is compatible and cessful successfully initialized. Initialization failed Venous probe was not connected Use original venous probe of the to the reference surface during corresponding CARDIOHELP-i.

  • Page 115: Bubble Monitoring: Function Test

    | CARDIOHELP System | 5 Preparing Application | 115 | Touch the symbol of one of the blood parameters (S , Hb or Hct) in the "Blood parameters" screen. ▶ The "Alarm settings ..." window is opened. Touch the "Initialize probe" symbol.

  • Page 116: Calibration

    | 116 | 5 Preparing Application | CARDIOHELP System | Close the venous bubble sensor. 10 Reset the bubble monitoring. ▶ The pump revolutions increase. 11 Switch the arterial bubble intervention off 12 Open the venous bubble sensor. ▶ The pump stops. The CARDIOHELP-i indicates bubble detection and generates a visual and acoustic high-priority alarm.

  • Page 117: Flow Off-Set Calibration Of The Flow/Bubble Sensor

    | CARDIOHELP System | 5 Preparing Application | 117 | 5.5.2 Flow Off-Set Calibration of the Flow/Bubble Sensor WARNING! If, after switching off, the flow display of a flow sensor located on a tube filled with liquid shows a value of > ± 1 lpm with the pump stopped, you should have the device checked by authorized service personnel to rule out flow inaccuracies.

  • Page 118: Checklists

    | 118 | 5 Preparing Application | CARDIOHELP System | Carry out the calibration for all the external pressure sensors. Observe the Instructions for Use for the external pressure sensor used. To calibrate a sensor, touch the "Zero calibration" symbol in the...

  • Page 119: Check Before Every Use In Intra-Hospital Transportation

    | CARDIOHELP System | 5 Preparing Application | 119 | Ensure that the flow/bubble sensor is positioned as described (⇨ "Connecting the Combined Arterial Flow/Bubble Sensor ", page 106). Ensure that the bubble sensor is positioned as described (⇨ "Connecting the Venous Bubble Sensor", page 107).
  • Page 120 | 120 | 5 Preparing Application | CARDIOHELP System | ▶ Check that a spare disposable set is available. ▶ Check that the emergency priming line is fully functional. Check the battery function before transportation. ▶ Disconnect the CARDIOHELP-i from the external power supply.

  • Page 121: During The Application

    | CARDIOHELP System | 6 During the Application | 121 | 6 During the Application WARNING! Only operate the CARDIOHELP-i with activated pressure and temperature sensors. Ensure that the warning and alarm limits, as well as interventions, are suitable for the patient and current situation (⇨ "Physiological Alarms and Interventions", page 121).

  • Page 122: Warning Limits, Alarm Limits And Interventions

    | 122 | 6 During the Application | CARDIOHELP System | WARNING! Do not remove any components during operation of the CARDIOHELP-i. CAUTION! If you do remove a component during operation, an alarm is triggered which can only be reset by switching the CARDIOHELP-i off and back on again.

  • Page 123: Pump Control Priorities

    | CARDIOHELP System | 6 During the Application | 123 | Intervention This function enables you to specify whether an intervention is triggered if the intervention condition is fulfilled. The following interventions are possible: – Increase or reduce the speed so that the parameter value is within the alarm limits again.

  • Page 124: Deactivating Warning/Alarm Limits

    | 124 | 6 During the Application | CARDIOHELP System | Priority Criterion Possible causes Setpoint speed (in RPM RPM Mode: User-defined setpoint speed > 0 rpm (⇨ mode) or setpoint flow (in "RPM mode: changing the speed", page 93)

  • Page 125: Activating/Deactivating Interventions With Button Combinations

    | CARDIOHELP System | 6 During the Application | 125 | The touchscreen displays [– – –] instead of a value for deactivated warning and alarm limits. Deactivating upper limit NOTE The upper alarm limit can only be deactivated following deactivation of the upper warning limit.

  • Page 126: Defining Monitoring Settings

    | 126 | 6 During the Application | CARDIOHELP System | Example: Symbol for Meaning arterial pressure Intervention deacti- To activate the intervention, hold down the safety but- vated ton and touch the symbol [pArt]. Intervention activated To deactivate the intervention, hold down the safety button and touch the symbol [pArt].

  • Page 127: Flow Monitoring

    | CARDIOHELP System | 6 During the Application | 127 | NOTE Interventions end when sensor is disconnected A malfunction in the touchscreen may prevent interventions from being deactivated in some circumstances. To deactivate them, disconnect the relevant sensor's connecting cable from the CARDIOHELP-i.
  • Page 128 | 128 | 6 During the Application | CARDIOHELP System | NOTE Confirming zero calibration With zero calibration, the CARDIOHELP-i displays a message, which you must confirm in order to carry out zero calibration (⇨ "Flow Off-Set Calibration of the Flow/Bubble Sensor", page 117).

  • Page 129: Lpm Mode: Speed Monitoring

    | CARDIOHELP System | 6 During the Application | 129 | WARNING! Backflow prevention triggered through negative flow To reset the backflow prevention, press the "Zero flow mode" button. If the backflow continues, the backflow prevention is activated again after 6 seconds.

  • Page 130: Pressure Monitoring

    | 130 | 6 During the Application | CARDIOHELP System | Limits Upper alarm limit To change a limit value, touch the field and adjust the value. Lower alarm limit To change a limit value, touch the field and adjust the value.
  • Page 131 | CARDIOHELP System | 6 During the Application | 131 | The pump starts again and the alarm ends as soon as the measured value is within the alarm limits again. – If the measured value is 10 mmHg at the most outside the alarm limits, the CARDIOHELP-i generates a medium-priority alarm and controls the pump in such a way that the pressure is within the alarm limits again.
  • Page 132 | 132 | 6 During the Application | CARDIOHELP System | NOTE Monitoring p : Only in thApp "MECC" The parameter p is only monitored in the thApp "MECC". In other thApps the CARDIOHELP-i does not generate any alarms, nor does it...

  • Page 133: Bubble Monitoring

    | CARDIOHELP System | 6 During the Application | 133 | Zero calibration External Pressure Sensors: Carrying out zero calibration (⇨ "External Pressure Sensors: Carrying Out Zero Calibration", page 117) Integrated Pressure Sensors: Carrying out zero calibration (⇨ "Integrated Pressure Sensors: Carrying Out Zero Calibration", page 116)
  • Page 134 | 134 | 6 During the Application | CARDIOHELP System | WARNING! The measurement of a flow/bubble sensor or optional bubble sensor which is not fitted or not fitted on the appropriate tube is interpreted as "Arterial bubble detected" or "Venous bubble detected" and triggers the corresponding alarms and interventions.
  • Page 135 | CARDIOHELP System | 6 During the Application | 135 | During a pump stop, retrograde blood flow may occur. Ensure that trained medical personnel are always present and able to respond to a bubble alarm immediately, remove the cause and reset the bubble alarm.

  • Page 136: Pressure Drop Monitoring

    | 136 | 6 During the Application | CARDIOHELP System | 6.2.5 Pressure Drop Monitoring This function monitors the calculated pressure drop between p and p . For this purpose, warning limits must be set. If the calculated value is outside of the warning limits, the CARDIOHELP-i generates a low-priority alarm.

  • Page 137: Temperature Monitoring

    | CARDIOHELP System | 6 During the Application | 137 | ▶ The field to be changed is highlighted in blue. Adjust the value with or [-]. To accept the changes, touch the [Confirm] symbol. To reject the changes, tap the [Reject] symbol.

  • Page 138: Blood Parameter Monitoring

    | 138 | 6 During the Application | CARDIOHELP System | Warning limits for venous temperature. Analogous for arterial temperature. Limits Upper warning limit To change a limit value, touch the field and adjust the value. Lower warning limit To change a limit value, touch the field and adjust the value.

  • Page 139: User Modes And User Functions

    | CARDIOHELP System | 6 During the Application | 139 | Save reference values Save reference values (⇨ "Saving reference values", page 139). Recalibrate values Enter the determined blood parameters (⇨ "Entering the Deter- mined Blood Parameters", page 140). Initialize probe Initialize venous probe (⇨...
  • Page 140 | 140 | 6 During the Application | CARDIOHELP System | Touch the symbol of one of the blood parameters (S , Hb or Hct) in the "Blood parameters" screen. ▶ The "Alarm settings…" window is opened. Touch the [Save reference values] symbol.

  • Page 141: Zero Flow Mode

    | CARDIOHELP System | 6 During the Application | 141 | Touch the [Recalibrate values] symbol. The touchscreen displays the following window: Saved reference values When saved Fields for laboratory values ▶ If no valid reference values have been saved, the touchscreen displays [–...

  • Page 142: Using The Timers

    | 142 | 6 During the Application | CARDIOHELP System | Deactivating the zero flow mode Press the "Zero flow mode" button. ▶ Zero flow mode is deactivated. 6.3.3 Using the Timers WARNING! Do not use for diagnosis Do not use the timers for diagnostic purposes. The timers are intended for providing additional information.

  • Page 143: Global Override" Mode

    | CARDIOHELP System | 6 During the Application | 143 | Touch the [Timer] symbol. ▶ The "Timer" screen is opened. Touch the [Countdown timer] symbol. ▶ The "Settings countdown timer" window is opened. Set the desired start time. To do this, touch the fields and adjust the values with and [-].

  • Page 144: Emergency Procedures

    | 144 | 6 During the Application | CARDIOHELP System | Interventions (⇨ "Physiological Alarms and Interventions", page 121) Backflow prevention (⇨ "Backflow Prevention", page 128) In "Global Override" mode, the CARDIOHELP-i generates a reminder signal once per minute if the "Reminder signal" option has been activated (⇨ "Define the Alarm Configuration", page 83).
  • Page 145 | CARDIOHELP System | 6 During the Application | 145 | WARNING! When the device is off When the CARDIOHELP-i is connected to the external power supply and is not switched on, the batteries are fully charged once. If stored for a prolonged period (with or without being connected to the external power supply), the batteries can discharge slowly.

  • Page 146: Resetting The Bubble Stop

    | 146 | 6 During the Application | CARDIOHELP System | 6.4.2 Resetting the Bubble Stop WARNING! If the pump stops during an application, the blood flow will be interrupted and supply to the patient will cease. Please ensure that the cause of the interruption to the pump is remedied as quickly as possible and that the pump is started up again as quickly as possible.

  • Page 147: Using The Emergency Mode

    | CARDIOHELP System | 6 During the Application | 147 | ▶ The CARDIOHELP-i starts the pump again and displays the "Interventions" screen. Touch the [Reject] symbol instead. ▶ The bubble stop is not reset, i.e., the pump remains at a standstill or in backflow prevention.

  • Page 148: Using The Emergency Drive With The Disposable Hls Retainer

    | 148 | 6 During the Application | CARDIOHELP System | In the emergency mode, the status bar continually displays the message [EMERGENCY MODE] and no other alarms. The CARDIOHELP-i generates a reminder signal once per minute, the LED ring of the "Emergency mode" button flashes.
  • Page 149 | CARDIOHELP System | 6 During the Application | 149 | WARNING! A speed of more than 5000 rpm may lead to increased blood trauma or to increased pressure in the perfusion system. Pay attention to the LED speed indicator (⇨ "CARDIOHELP Emergency Drive", page 199).
  • Page 150 | 150 | 6 During the Application | CARDIOHELP System | Press the disposable's locking device to the middle, turn the disposable clockwise slightly and remove from the CARDIOHELP-i. Fix the disposable to the CARDIOHELP Emergency Drive: ▶ Fit the disposable under the upper locating lug [1]...
  • Page 151 | CARDIOHELP System | 6 During the Application | 151 | Removing the disposable from the CARDIOHELP Emergency Drive Open the lower locking device. Remove the disposable and release the lower locking device. Instructions for Use | 2.3 | en | 09...

  • Page 152: Concluding The Application

    | 152 | 7 Concluding the Application | CARDIOHELP System | 7 Concluding the Application 7.1 On Completion of the Application 7.1.1 Switch Off the CARDIOHELP-i Press the "On/Off" button for at least 3 seconds. Shutting down... ▶ The touchscreen displays the following message:...

  • Page 153: Removing The Disposable With Hls Drive

    | CARDIOHELP System | 7 Concluding the Application | 153 | Open the cover of the bubble sensor and remove the tube from the sensor. ▶ Press down the round button on the probe. Remove the probe from the measuring cell and pull it out of the tab of the measuring cell.

  • Page 154: Check List: Concluding The Application

    | 154 | 7 Concluding the Application | CARDIOHELP System | Dispose of the disposable according to your hospital's rules and national regulations. Clean and disinfect the CARDIOHELP-i and the accessories used (⇨ "Cleaning and Disinfection", page 184). 7.2 Check list: Concluding the Application Switch off the CARDIOHELP-i (⇨...

  • Page 155: Troubleshooting

    | CARDIOHELP System | 8 Troubleshooting | 155 | 8 Troubleshooting WARNING! Contact authorized service personnel If you detect a fault or failure of controls, display elements or sensors, have the CARDIOHELP-i checked by authorized service personnel. Error Description/possible conse-...
  • Page 156 | 156 | 8 Troubleshooting | CARDIOHELP System | Error Description/possible conse- Possible remedies quences "Zero flow mode" button failure The zero flow mode cannot be Switch to LPM mode and activated. set a setpoint flow of 0 l/ min. This causes the CARDIOHELP-i to aim at a flow of 0 l/min.

  • Page 157: Messages

    | CARDIOHELP System | 9 Messages | 157 | 9 Messages 9.1 Saving Alarms Alarms, interventions, measurements and events (e.g., pressed buttons) are saved and can be read out after the device has been switched off and back on. NOTE Alarm List The last 6 alarms can be displayed in the alarm list (⇨...

  • Page 158: Alarm List

    | 158 | 9 Messages | CARDIOHELP System | NOTE Data recording in emergency mode In the emergency mode, offline recording on the internal memory is switched off. User events, service events and online recording still function (⇨ "Using the Emergency Mode", page 147).

  • Page 159: High-Priority

    | CARDIOHELP System | 9 Messages | 159 | Low-priority: Physiological alarm conditions which lead to a warning or an alarm without intervention Higher priority alarms generate more alarm tones than alarms with lower priority. Higher priority alarm tones are repeated at shorter intervals than alarms tones with lower priority.
  • Page 160 | 160 | 9 Messages | CARDIOHELP System | above stop limit Medical grounds, blockage in Replace disposable. the gas transfer module and/or Removal of blockage behind the pump outlet, incor- Adjust limit. rect measurement or incorrectly Calibrate pressure set limit. Consequence: Pump transducer.
  • Page 161 | CARDIOHELP System | 9 Messages | 161 | WARNING! Monitoring of pAux only in the thApp "MECC" The thApp “MECC” is not to be used as there is currently no compatible disposable product available in the United States for use with the thApp “MECC”.
  • Page 162 | 162 | 9 Messages | CARDIOHELP System | LPM below limit Medical grounds, blockage up- Removal of blockage. stream or downstream of the Increase RPM. pump, blockage in the gas Correct the flow sensor. transfer module, incorrect mea- Reduce the peripheral surement or incorrectly set limit, resistance.

  • Page 163: Medium Priority

    | CARDIOHELP System | 9 Messages | 163 | 9.3.2 Medium Priority Message Possible causes/conse- Possible remedies quences below alarm limit Medical grounds, blockage on Volume administration as the venous side, incorrect mea- per volume status. surement or incorrectly set limit.
  • Page 164 | 164 | 9 Messages | CARDIOHELP System | above alarm limit Medical grounds, blockage Check position of the downstream of the pressure pressure transducer. measurement point, incorrect Replace disposable. measurement or incorrectly set Removal of blockage. limit. Adjust limit.
  • Page 165 | CARDIOHELP System | 9 Messages | 165 | Pressure drop above limit Blockage in the oxygenator, in- Replace disposable. correct measurement or incor- Removal of blockage. rectly set limit. Adjust limit. Calibrate pressure transducer. Replace pressure transducer. RPM above limit Medical grounds, incorrect Removal of blockage.

  • Page 166: Low Priority

    | 166 | 9 Messages | CARDIOHELP System | 9.3.3 Low Priority Message Possible causes/conse- Possible remedies quences outside of measuring range Measured value outside of valid Check plausibility. range. Replace sensor cable. Calibrate pressure transducer. Replace pressure transducer. Dry pressure transducer.
  • Page 167 | CARDIOHELP System | 9 Messages | 167 | outside of measuring range Measured value outside of valid Check plausibility. range. Replace sensor cable. Calibrate pressure transducer. Replace pressure transducer. Dry pressure transducer. above warning limit Medical grounds, blockage on the arterial side, incorrect mea- surement or incorrectly set limit.
  • Page 168 | 168 | 9 Messages | CARDIOHELP System | below warning limit Medical grounds, incorrect Check position of the measurement or incorrectly set pressure transducer. limit. Replace disposable. Removal of blockage. Adjust limit. Calibrate pressure transducer. Replace pressure transducer. Use larger cannula.
  • Page 169 | CARDIOHELP System | 9 Messages | 169 | below limit. Medical grounds, incorrect Check plausibility. measurement or incorrectly set Adjust limit. limit. Replace sensor. Check sensor position. outside of measuring range Measured value outside of valid Check plausibility. range.
  • Page 170 | 170 | 9 Messages | CARDIOHELP System | Venous bubble detected Gas bubbles in the system or Clamp, de-air or replace bubble sensor removed from system. Reset the bubble tubing. alarm (⇨ "Resetting the Bubble Stop", page 146). WARNING: Risk of air...

  • Page 171: Technical Alarms

    | CARDIOHELP System | 9 Messages | 171 | Hct outside of measuring range Measured value outside of valid Check plausibility. range. Check and correct hemoglobin level Calibrate blood parameter measurement. Check measuring cell detection. Hb above limit Medical grounds, incorrect Check plausibility.

  • Page 172: High Priority

    | 172 | 9 Messages | CARDIOHELP System | Higher priority alarms generate more alarm tones than alarms with lower priority. Higher priority alarm tones are repeated at shorter intervals than alarms tones with lower priority. The touchscreen displays technical alarm situations via the status bar (⇨ "Status Bar", page 42) and the "Menu"...
  • Page 173 | CARDIOHELP System | 9 Messages | 173 | No batteries detected No batteries detected. Battery Use other power supply. operation is not possible. Replace the CARDIOHELP-i as quickly as possible. Notify authorized service. RPM control error Speed control error. Drive Taking the CARDIOHELP-i restarts.

  • Page 174: Medium Priority

    | 174 | 9 Messages | CARDIOHELP System | 9.4.2 Medium Priority Message Possible causes/conse- Possible remedies quences Device defective (0x00000) Serious technical fault. Continually check 0x00000 defines an error code. perfusion on the This varies depending on the CARDIOHELP-i and by cause of the fault and is re- monitoring the patient.
  • Page 175 | CARDIOHELP System | 9 Messages | 175 | Battery defective Battery defective. Do not operate the CARDIOHELP-i using batteries. Do not disconnect the CARDIOHELP-i from external power supply. Replace the CARDIOHELP-i as quickly as possible. Notify authorized service. No disposable detected...
  • Page 176 | 176 | 9 Messages | CARDIOHELP System | Battery 2 not charging Battery 2 not charging Only operate the CARDIOHELP-i with the external power supply. Restart the CARDIOHELP- Taking the CARDIOHELP-i out of service. Notify authorized service. Call Service Check alarm set-...

  • Page 177: Low Priority

    | CARDIOHELP System | 9 Messages | 177 | 9.4.3 Low Priority Message Possible causes/conse- Possible remedies quences pVen sensor disconnected Sensor was disconnected. Reconnect sensor to CARDIOHELP-i or replace external sensor or cable for the sensors. pVen sensor defective Replace external sensor or cable for sensor system.
  • Page 178 | 178 | 9 Messages | CARDIOHELP System | Flow sensor disconnected Sensor was disconnected. Reconnect sensor to CARDIOHELP-i. Flow sensor defective Replace external sensor No flow signal No valid flow signal Correct positioning of flow sensor. If necessary replace flow sensor.
  • Page 179 | CARDIOHELP System | 9 Messages | 179 | Switched to battery operation No external power supply. If necessary, acknowledge CARDIOHELP-i has automati- acoustic signal via battery cally switched to battery opera- dialog. tion. Ext. TVen not calibrated Temperature sensor not cali- Notify authorized service.
  • Page 180 | 180 | 9 Messages | CARDIOHELP System | Battery 2 not charging Battery cannot be charged. Bat- NOTICE! Do not use DC power tery power is not guaranteed. supply. With DC power supply: Voltage below 11 V. With DC power supply:...

  • Page 181: Messages

    | CARDIOHELP System | 9 Messages | 181 | Internal memory full Offline Memory for perfusion data is recording stopped full. Data recording was stopped. Continuing to save data will delete existing data. Operating time limit is reached Operating time limit reached.
  • Page 182 | 182 | 9 Messages | CARDIOHELP System | Overwrite? ⇨ "Recalibrating Blood Parameters", page Really overwrite already saved reference val- 139. ues? Cancel = keep saved values At least one of the values is outside the ex- pected range. Save anyway? Is the tube clamped upstream and downstream ⇨...

  • Page 183: Self-Test Failure Report

    | CARDIOHELP System | 9 Messages | 183 | 9.6 Self-Test Failure Report The CARDIOHELP-i will automatically perform a self-test after being switched on. Should an error occur during the self-test, the touchscreen displays a self-test failure report: Touch the symbol [Confirm] to close the failure report.

  • Page 184: Cleaning And Disinfection

    | 184 | 10 Cleaning and Disinfection | CARDIOHELP System | 10 Cleaning and Disinfection 10.1 Surface Cleaning and Disinfecting After Each Use WARNING! Switch off the device and disconnect it from the external power supply before cleaning. WARNING! Do not use chemical solvents and do not spill anesthetics.
  • Page 185 | CARDIOHELP System | 10 Cleaning and Disinfection | 185 | Remove the connection cable from the venous probe. Hold down the round knob [1] on the probe. Undo the screw [2] with a hexagon socket wrench and unscrew from the probe.
  • Page 186 | 186 | 10 Cleaning and Disinfection | CARDIOHELP System | 11 Securely tighten the screw with a hexagon socket wrench. 12 Connect the connection cable to the venous probe. Instructions for Use | 2.3 | en | 09 Copyright Maquet Cardiopulmonary GmbH...

  • Page 187: Maintenance

    | CARDIOHELP System | 11 Maintenance | 187 | 11 Maintenance Maintenance includes all measures that ensure the device is functioning properly and is free of damage, in order to enable safe use for the intended purpose: Maintenance by the operator...

  • Page 188: Changing Fuses

    | 188 | 11 Maintenance | CARDIOHELP System | 11.2 Changing Fuses WARNING! Check that you are using correct and suitable fuses (⇨ "CARDIOHELP-i Device", page 196). Disconnect the CARDIOHELP-i from the external power supply. Press the lever on the fuse module and pull the fuse module out.

  • Page 189: Repair

    Repairing restores the proper functioning of the device and ensures it is free from damage. It is necessary if, for example, a fault has occurred in the device. WARNING! Repairs may only be carried out by a service technician authorized by Maquet. 11.4.1 Send Device to Authorized Service Point Switch off the device.

  • Page 190: Initial Set-Up

    | 190 | 12 Initial Set-Up | CARDIOHELP System | 12 Initial Set-Up 12.1 Overview Initial set-up includes all measures required to make the device ready for use and ensure its initial use is safe and as intended. WARNING! Before the initial setup, read the Instructions for Use and all documents included with the delivered device.

  • Page 191: Checking Setup Prerequisites

    | CARDIOHELP System | 12 Initial Set-Up | 191 | 12.3 Checking Setup Prerequisites Ensure that the following prerequisites have been met: The initial setup training for this or an identical device has been completed. The EoL report for the device delivered is present.

  • Page 192: Function Test

    | 192 | 12 Initial Set-Up | CARDIOHELP System | 12.5 Function Test 12.5.1 Checking Mechanical Components Check the mechanical function of the following components: Locking/release mechanism of the safety bar (⇨ "Closing the Safety Bar", page 67) Locking/release mechanism of the holder for the CARDIOHELP Emergency...

  • Page 193: Checking The Controls

    | CARDIOHELP System | 12 Initial Set-Up | 193 | Check successful initialization of the venous probe (⇨ "Checking the Status of the Venous Probe and Measuring Cell", page 112). If the self-test does not proceed as described, do not operate the device and have it tested by authorized service personnel.

  • Page 194: Accessories

    | 194 | 13 Accessories | CARDIOHELP System | 13 Accessories 13.1 Overview Sensors Flow/bubble sensor FBS 3/8" x 3/32" L0.9 (standard accessory) Bubble sensor BS 3/8" x 3/32" L1.7 Venous probe Venous probe Connection cable for venous probe CC-VP L0.32 Connection cable for disposable: for HLS Set / QUADROX-iR (simple cable,...

  • Page 195: Battery Calibration Unit (Optional)

    | CARDIOHELP System | 13 Accessories | 195 | Storage and non-operating transport Protection cover CARDIOHELP Protection Cover (included with Cardiohelp Mobile Holder HKH 8860) Transport box Transport case for CARDIOHELP-i Trolley Transport System Data exchange USB 2.0 cable type A / type B Length 1.8 m...

  • Page 196: Technical Data

    | 196 | 14 Technical Data | CARDIOHELP System | 14 Technical Data 14.1 CARDIOHELP-i Device Classification in accordance Class IIb with Council Directive 93/42/ EEC concerning medical de- vices, Appendix IX Degree of protection in accor- IPX1 (protection against vertically dripping water) dance with IEC 60529...
  • Page 197 | CARDIOHELP System | 14 Technical Data | 197 | Rear connections 4 external pressure sensors Sensors of disposable Clamp (not used) Bubble sensor Venous probe Level sensor 2 external temperature sensors Flow/bubble sensor Battery Calibration Unit Speaker for acoustic signals Volume depends on the priority of the alarm (⇨ "Messages", page 157) and the volume set by the user (⇨...

  • Page 198: Applied Parts

    | 198 | 14 Technical Data | CARDIOHELP System | Power supply Charging time 5 h max. 7 h max. a. The specified charging time relates to devices with 0 rpm or when the device is switched off. b. Depending on the set speed (rpm), the charging time can increase during operation of the CARDIOHELP-i.

  • Page 199: Sensors

    | CARDIOHELP System | 14 Technical Data | 199 | 14.4 Sensors Bubble sensor BS 3/8" x 3/32" L1.7 / BS 3/8" x 1/16" - 1/4" x 3/32" L1.7 Bubble sensor Ultrasound Backflow prevention (with activated intervention) Air bubbles dia. ≥ 5 mm Flow/bubble sensor FBS 3/8"...

  • Page 200: Ambient Conditions

    | 200 | 14 Technical Data | CARDIOHELP System | Dimensions W x H x D Cardiohelp Mobile Holder HKH 8860 465 x 264 x 374 mm Transport Guard for CARDIOHELP Disposables 250 x 150 x 50 mm Weights Cardiohelp Mobile Holder HKH 8860 4.2 kg CARDIOHELP-i Approx. 12 kg Infusion bag Max. 2 kg per bag Max. 4 kg in total...

  • Page 201: Measured Data And Displayed Data

    | CARDIOHELP System | 14 Technical Data | 201 | 14.8 Measured Data and Displayed Data NOTE Measuring accuracies related to the entire system The measuring accuracies named each relate to the entire measurement system, consisting of the sensor and the CARDIOHELP-i device.

  • Page 202: Flow

    | 202 | 14 Technical Data | CARDIOHELP System | 14.8.1 Flow Measuring accuracy Flow 0 … 1 l/min ± 0.16 l/min Flow > 1 l/min ± 7% of the measured value ± 0.06 l/min 14.8.2 Pressure External sensors Measuring accuracy Pressure range -30 … +100 mmHg ± 3 mmHg device accuracy ± 3 mmHg sensor accuracy Pressure range +101 …...

  • Page 203: Components Supplied

    | CARDIOHELP System | 14 Technical Data | 203 | Ambient temperature Blood temperature Flow rate Measuring accuracy +15 … +30°C +18 … +28 °C 3.0 ... 7.0 l/min -0.4 ... +1.3 °C 0.5 ... 3.0 l/min -1.6 ... +1.6 °C A. Outside of the ranges listed, larger measurement inaccuracies are possible.
  • Page 204 | 204 | 14 Technical Data | CARDIOHELP System | Parameter Possible settings Factory setting Limits Resolution Lower / upper Intervention limit Flow 0 … 9.9 l/min 0.0 / 8.0 deactivated Speed 0 … 5000 rpm 0 / 4500 deactivated Pressures: -500 … +900 mmHg Warning: – / 400 deactivated Alarm: –...

  • Page 205: 3General Settings

    | CARDIOHELP System | 14 Technical Data | 205 | 14.10.3 General Settings Option Possible settings Factory setting thApp Cardiopulmonary support, cardiac MECC support, MECC, pulmonary support, elimination WARNING! Only use thApp “Cardiopulmonary Support”. The thApp “Circulatory Support”, “Pulmonary Support”, and “CO Removal”...

  • Page 206: 4Recalibrating Blood Gas Values

    | 206 | 14 Technical Data | CARDIOHELP System | Option Possible settings Factory setting Time/date: Date format DD.MM.YYYY, MM/DD/YYYY DD.MM.YYYY Time format hh:mm:ss, hh:mm hh:mm:ss 12 h, 24 h 24 h a. Depending on the thApp used (⇨ "thApp-specific Parameters and Functions", page 29).

  • Page 207: Applied Standards

    | CARDIOHELP System | 15 Applied Standards | 207 | 15 Applied Standards 15.1 Electromagnetic Compatibility (EMC) The objective of the EMC declaration is to enable the responsible organization to decide whether the CARDIOHELP-i is suitable for its electromagnetic environment.
  • Page 208 | 208 | 15 Applied Standards | CARDIOHELP System | Immunity test IEC 60601 test Compliance level Electromagnetic environment – level guidance Surges ±1 kV differential ±1 kV differential Mains power quality should be that of IEC 61000-4-5 mode mode the environment of professional healthcare facilities or the environment ±2 kV common...
  • Page 209 | CARDIOHELP System | 15 Applied Standards | 209 | Immunity test IEC 60601 test Compliance level Electromagnetic environment – level guidance Radiated RF 10 V/m 80 MHz to 10 V/m WARNING! Portable RF communica- IEC 61000-4-3 2.7 GHz tions equipment (including its acces- sories such as antenna cables and ex- High-frequency 380 - 390 MHz...
  • Page 210 | 210 | 15 Applied Standards | CARDIOHELP System | Separation distances from RF communication equipment. WARNING! Portable RF communications equipment (including its accessories such as antenna cables and external antennas) should not be used within 30 cm (or 12 inches) or manufacturer-designated parts and cables of the CARDIOHELP-i device.
  • Page 212 For local contact: Please visit our website www.getinge.com Maquet Cardiopulmonary GmbH Kehler Strasse 31 76437 Rastatt GERMANY www.getinge.com info.cp@getinge.com...

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