HL 20 HEART-LUNG MACHINE User Manual Aug 2014

Copyright 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 AG 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. Manufacturer MAQUET Cardiopulmonary AG Kehler Straße 31 76437 Rastatt GERMANY Phone: +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com

| HL 20 | Content | 3 |

Content 1

2

3

General ...8 1.1

Information on these Instructions for Use ...8 1.1.1 Symbols ...8 1.1.2 Definitions ...8

1.2

Environmental Protection...9 1.2.1 Packaging ...9 1.2.2 Batteries ...9 1.2.3 Disposal ...9

1.3

Abbreviations ...9

Safety ...11 2.1

Intended Purpose...11 2.1.1 Intended Use ...11 2.1.2 Intended User ...11 2.1.3 Intended Patients...11 2.1.4 Intended Environment ...11 2.1.5 Indications ...11 2.1.6 Contraindications ...11 2.1.7 Side Effects ...11

2.2

General Safety Instructions...11 2.2.1 General risks in the use of heart-lung machines ...12 2.2.2 Position of Use and Operation and Positioning of the HL 20 ...14 2.2.3 Handling the HL 20 ...16 2.2.4 General Precautionary Measures During Use ...17 2.2.5 External Devices...18

2.3

Electromagnetic Compatibility...21

2.4

Symbols ...22

2.5

Rating Plate ...24

System Description ...25 3.1

Disposables ...25

3.2

System Definition ...25

3.3

Base console ...27 3.3.1 Base Console Sockets ...28 3.3.2 Control and Display Elements on the Base Console ...29 3.3.3 Status Display of the Console Power Supply ...29 3.3.4 Battery Operation ...30 3.3.5 Status of the Power Supply During Battery Operation ...32 Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| 4 | Content | HL 20 |

3.4

Module Rack ...32 3.4.1 Console Modules for Monitoring (Optional) ...33 3.4.2 Status Display on the Console Modules ...33 3.4.3 Status Display on the Power Supply Module...34

3.5

Sensors...34 3.5.1 Temperature Sensor...35 3.5.2 Pressure Sensor ...35 3.5.3 Bubble Sensor ...36 3.5.4 Level Sensor...36

3.6

System Control Panel (SCP) ...36 3.6.1 Basic Functionality...38 3.6.2 Pulsatile Control ...39 3.6.3 Power Supply Monitoring...41 3.6.4 Timer ...41 3.6.5 Pressure Monitoring ...42 3.6.6 Temperature Monitoring ...44 3.6.7 Level Monitoring ...45 3.6.8 Bubble Monitoring...46

3.7

Cardioplegia Monitor Unit (CMU)...47

3.8

Pump Modules ...48 3.8.1 Roller Pump Module (RPM)...49 3.8.2 Twin Pump Module (TPM) ...50 3.8.3 Pump Head (RPM/TPM)...50

3.9

Operating Panel (RPM/TPM) ...51

3.10 Permitted External Devices...53 3.11 Physiological Alarms and Interventions ...55 3.11.1 Overview...55 3.11.2 Alarm Limits and Interventions ...55 3.11.3 Interventions in General ...56 3.11.4 Speed Criteria...56 4

System Preparation...58 4.1

Setting Up and Connecting ...58 4.1.1 Setting Up the HL 20 ...58 4.1.2 Opening the Module Flap ...58 4.1.3 Setting the Flexible Holder for the SCP ...59 4.1.4 Fitting the Additional Pole System ...59 4.1.5 Fitting the LED Lamp ...59 4.1.6 Connecting the HL 20 ...60

4.2

Using a Multiple Socket ...61

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| HL 20 | Content | 5 |

5

4.3

Connecting External Devices (Optional) ...62 4.3.1 Connecting the HCU 20 Up To the SYS-COM Port ...62 4.3.2 Connecting Devices to the Digital Communication Module (DIO) ...63

4.4

Switching On the HL 20, Self-Test...63 4.4.1 Switching the LED Lamp On and Off...64

4.5

Pump Configuration ...64 4.5.1 Positioning the Pump...64 4.5.2 Switching the Pump On ...65 4.5.3 Initializing the Pump ...65 4.5.4 Removing the Pump ...65 4.5.5 Operating Modes ...66 4.5.6 Changing Mode ...67 4.5.7 Defining the Tube Size ...67 4.5.8 Switching Information Tone On/Off ...68 4.5.9 Display Brightness ...68

4.6

Pump Modes (Perfusion) ...69 4.6.1 Starting the Pump ...69 4.6.2 Reversed Pumping ...69 4.6.3 Operation as Master/Slave Pumps ...70 4.6.4 Internally Controlled Pulsatile Pumping ...71

4.7

Configuring Cardioplegia Pumps ...72 4.7.1 Cardioplegia with a Twin Pump Module (TPM) ...73

Preparing Application ...75 5.1

Preparing Roller Pumps...75 5.1.1 Roller Pump Module (RPM): Changing Tubing Guide Inserts ...75 5.1.2 Roller Pump Module (RPM): Inserting the Tube...76 5.1.3 Twin Pump Module (TPM): Changing Tubing Guide Inserts ...77 5.1.4 Twin Pump Module (TPM): Inserting the Tube ...78 5.1.5 Adjusting the Occlusion ...80 5.1.6 Pump Modules: Performing Flow Calibration ...81

5.2

Preparing Monitoring Modules ...82 5.2.1 Determining Interventions...82

5.3

Bubble Monitoring ...83 5.3.1 Preparing Bubble Monitoring ...84

5.4

Level Monitoring...85 5.4.1 Preparing Level Monitoring...86

5.5

Pressure Monitoring...88 5.5.1 Preparing Pressure Monitoring and Inserting the Pressure Sensors ...89

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| 6 | Content | HL 20 |

6

7

8

9

5.6

Temperature Monitoring...93 5.6.1 Preparing Temperature Monitoring and Inserting the Temperature Sensor ...93

5.7

Function Tests ...95 5.7.1 Switching On the HL 20, Self-Test ...95 5.7.2 Bubble Detection: Function Test ...95 5.7.3 Level Monitoring: Function Test ...96 5.7.4 Pressure Monitoring: Function Test...96 5.7.5 Defining the Charge Level of the Batteries ...97 5.7.6 Master/Slave Cardioplegia Pump: Function Test ...97 5.7.7 Arterial Pump Stop Connection To the Cardioplegia Pump Function Test...98 5.7.8 Master/Slave Arterial Pump: Function Test ...98

5.8

Checklists...98 5.8.1 Check Before Every Application ...98

During the Application ...101 6.1

Using the HL 20 ...101 6.1.1 "Override" Button ...101 6.1.2 Disabling Acoustic Alarms ...102

6.2

Performing Cardioplegia ...102

6.3

Emergency Procedures ...103 6.3.1 Switched Off System Control Panel ...103 6.3.2 Using the Hand Crank ...103

Concluding the Application...106 7.1

After Use ...106 7.1.1 Switching off the HL 20...106 7.1.2 Removing Sensors and Disposables...106 7.1.3 Cleaning the HL 20 ...106

7.2

Checklist: Concluding the Application...106

Messages...107 8.1

High-Priority Alarms ...107 8.1.1 Physiological Alarms ...107 8.1.2 Technical Alarms ...107 8.1.3 Temperatures ...111

8.2

Pump Self-Test ...112

Cleaning and Disinfection ...113 9.1

Cleaning...113

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| HL 20 | Content | 7 |

9.2 10

Disinfection ...113

Maintenance...114 10.1 Inspection and Maintenance by the Operator ...114 10.1.1 Checking the Guide Rollers for Tubing...114 10.1.2 Checking Battery Capacity ...115 10.2 Inspection and Maintenance by Authorized Service Personnel...115 10.2.1 Inspection ...115 10.2.2 Changing the Batteries ...115 10.3 Repair ...115 10.4 Authorized Service...116

11

Initial Installation...117

12

Accessories...118 12.1 HL 20 ...118 12.1.1 Base Console ...118 12.1.2 Pump Modules...119 12.1.3 Monitoring System ...120 12.2 Additional Medical Devices ...121

13

Technical Data ...122 13.1 Base Console...122 13.1.1 Console Modules ...123 13.1.2 DIO pin assignment ...125 13.2 Power Supply...126 13.3 Acoustic Signals (SCP)...127 13.4 Pump Modules ...127 13.4.1 Tubing...128 13.4.2 Overflow Protection ...128 13.4.3 Flow Diagram ...129 13.5 Ambient Conditions...130 13.6 Measured Data and Displayed Data ...130 13.6.1 Pumps and Consoles ...130 13.7 Factory Settings ...131 13.8 Additional Connectible Devices ...131

14

Applied Standards...132 14.1 Safety Information...132 14.2 Electromagnetic Compatibility (EMC) ...132

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| 8 | 1 General | HL 20 |

1 General 1.1 Information on these Instructions for Use These Instructions for Use will familiarize you with the features of the MAQUET product. 1.1.1 Symbols References References to other pages in these Instructions for Use begin with the arrow sign "⇨". Action and reaction The user's actions are identified with numbered paragraphs "1", while the "▶" symbol identifies the reaction triggered in the system. Example: n Switch the light switch on. Buttons and menus The buttons and menus are shown in square brackets. Example: n Press the [DOWN] button in the [Operation] menu. 1.1.2 Definitions DANGER! Identifies an immediate, serious risk to people which will result in death or serious injury. WARNING! Identifies a general, serious risk to people which can result in death or serious injury. CAUTION! Identifies a possible risk which can result in injury.

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| HL 20 | 1 General | 9 |

NOTICE! Identifies a possible risk to property which can result in equipment damage and/ or data loss. Structure of the other information Information concerning events without personal injury or equipment damage is indicated as follows: NOTE Additional support and other helpful information.

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 To ensure optimal utilization of the raw materials, the product as well as the components and accessories must not be disposed of with normal domestic waste. Keep separate from domestic waste and dispose of in an environmentally safe way in compliance with local regulations. n Before disposal, decontaminate all parts in accordance with the procedures applicable in clinical practice. n In order to prevent risks during disposal, contact the authorized service personnel.

1.3 Abbreviations Abbreviation

Meaning

ABS

Air Bubble Sensor

AEP

Bubble/level monitoring module (Air emboli Protection Module)

CCM

Console Control Module

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| 10 | 1 General | HL 20 |

CLS

Capacitive Level Sensor

DIO

Digital Communication Module

DPM

Dual Pressure Module

HEC

Hexadecimal Error Code

LEMO

Special contact plug for data transmission

lpm

Liters per minute

MDD

Medical Device Directive as per the Directive 93/42/EEC for Medical Devices

ODU

Connector for data and power supply to the pump modules

PSM

Power Supply Module

QTM

Quad Temperature Module

REF

Reference number

rpm

Revolutions per minute

RPM

Roller Pump Module (single)

SCP

System Control Panel

TPM

Twin Pump Module

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| HL 20 | 2 Safety | 11 |

2 Safety 2.1 Intended Purpose 2.1.1 Intended Use The HL 20 (device) is intended for use in maintaining or assisting in extracorporeal blood circulation. It is most commonly used during surgical procedures when the heart and circulation have to be stopped to perform the procedure. 2.1.2 Intended User The HL 20 may only be operated by medical personnel that are deemed competent in performing extracorporeal circulation based on regional regulatory and recognized certification authorities. 2.1.3 Intended Patients The HL 20 can be used for all patients, irrespective of age, size, and weight. 2.1.4 Intended Environment The HL 20 is intended for use inside a clinical institution. 2.1.5 Indications The indication for use of the HL 20 must be made by the responsible physician. Careful consideration of all possible treatment options includes an assessment of the risks and benefits. 2.1.6 Contraindications No contraindications are known when the HL 20 is used as specified. 2.1.7 Side Effects A possible side effect when using the HL 20 is hemolysis.

2.2 General Safety Instructions WARNING! n Prior to using the system, please read these Instructions for Use and the Instructions for Use of all the approved disposables and accessories used.

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| 12 | 2 Safety | HL 20 |

NOTICE! n Keep the Instructions for Use with the unit so that you can refer to them in case of emergency or uncertainty. 2.2.1 General risks in the use of heart-lung machines Technical resources alone cannot ensure the safe use of a heart-lung machine. Because of this, the knowledge and skills of the user are decisive.

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| HL 20 | 2 Safety | 13 |

WARNING! n The system must be operated by medical staff who, on the basis of regional laws and approval from the recognized authorities, are regarded as qualified for performing extracorporeal circulation (⇨ "Intended User", page 11). n The system must be monitored and documented by medical staff who, on the basis of regional laws and approval from the recognized authorities, are regarded as qualified for performing extracorporeal circulation. Clinical procedures and methods are the responsibility of the physician. n A preliminary test of the system must be carried out before use (⇨ "Check Before Every Application", page 98). n To maintain operational safety, regular maintenance must be carried out. Maintenance may only be carried out by a service technician authorized by MAQUET. n Ensure that all components have compatible software and hardware versions, which are verified by a service technician authorized by MAQUET during the installation and maintenance. n You should always keep a replacement unit on standby in order to ensure continuous operation in the event of a complete system failure. n The improper use of a heart-lung machine can lead to insufficient patient care (e.g., with insufficiently oxygenated blood or insufficient blood flow) or to other life-threatening situations for the patient. The system must only be used in accordance with the respective Instructions for Use of the components used. n The use of an improper extracorporeal circuit can lead to the ingress of air into the patient, to insufficient patient care or to other life-threatening situations for the patient. Check the integrity, completeness and proper connection of the extracorporeal circuit before starting operation. With regard to the handling of the disposables, please observe their Instructions for Use. For the de-airing of the extracorporeal circuit, observe the Instructions for Use for the disposables used. Always have disposables readily available to enable quick replacement during application.

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| 14 | 2 Safety | HL 20 |

WARNING! n During clinical use of the system, the medical personnel must always be able to resuscitate and intubate the patient. n Given the risk of negative pressure in the vascular system during extracorporeal circulation, all artificial vascular accesses must be protected against the ingress of air. Before placing the artificial vascular access, it must be de-aired. Particular care must be taken to ensure that intravenous medications are administered free of air bubbles. Given the risk of negative pressure, a safety measure (ligature or similar) must be taken prior to the surgical opening of the venous vessel to prevent the ingress of air. n When handling blood, please observe the hospital's applicable safety regulations and hygiene protocol. n If you use halogen lamps, do not position these next to blood-carrying tubes due to the heat generated by the halogen lamp. 2.2.2 Position of Use and Operation and Positioning of the HL 20 The HL 20 must be positioned so that the user can see all of the displays at all times, can operate all of the controls and components and access interfaces, and so that the HL 20 is not interfered with by other devices or vice versa. WARNING! n Ensure that the operating position requirements of the attached disposable are complied with (⇨ Instructions for Use of the disposable). n Ensure that you can see the system control panel and displays of the HL 20's pumps as well as any optical warning signals at all times. In noisy environments, there is a risk that acoustic warning signals emitted by the HL 20 may not be heard. n Ensure that the patient does not come into contact with the housing, plug connections or conducting parts when additional measures are being performed, e.g., defibrillation. n Do not use the system in the presence of escaping flammable or combustible gases.

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| HL 20 | 2 Safety | 15 |

WARNING! n Only operate the HL 20 within the specified ambient conditions(⇨ "Ambient Conditions", page 130). Ambient temperatures outside the specified specification (especially temperatures) can disrupt the sensors' measurements. This may result in incorrect measurements, which may cause incorrect values to be displayed and trigger alarms. There must be no risk of condensation. Condensation may occur when the device is taken from a cold environment into a warm room. n Only attach the intended components to the HL 20. Otherwise, the limits of the safe workload may be exceeded and the mechanical stability of the HL 20 may be affected. n Observe the load limits of the top shelf and poles (⇨ "Base Console", page 122 ). n All connected parts, devices, and modules must be firmly and correctly connected. Check the mechanical stability. n Make sure that the ventilation openings are not obstructed and the HL 20 is not covered. There is a risk that the HL 20 will overheat. Ensure a minimum distance of 50 cm to other devices, objects, or the wall. n Avoid kinking tubes and cables. n In order to protect the patient and the operator, the HL 20 must be connected to an external power supply with a functional protective ground conductor. Make sure that the device can be disconnected from the power supply (actuation of the mains circuit breaker and removal of the power cord) at all times.

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| 16 | 2 Safety | HL 20 |

2.2.3 Handling the HL 20 WARNING! n Use an independent power source which is protected by an appropriate fuse. n Only use devices and equipment which are functioning perfectly. Check the devices and equipment before use. Defective devices or equipment must be replaced. n Only use heat exchangers (disposables) that are resistant to voltage discharges. n Additional equipment must be correctly secured. n To ensure patient safety, only use tested devices, parts, accessories, and disposables which are approved for the HL 20. n Take damaged devices out of service immediately and have them tested by the authorized service personnel. n Maintenance work, repairs, changes, and modifications to the device may only be performed by the authorized service personnel. In order to ensure safe use of the device, regular inspections are essential. n The operator is not permitted to change or modify the device. n The user is responsible for ensuring that the extracorporeal circulation is set up properly and that its function is tested before use. n Do not sit on the side guard. n Ensure that the modules and accessories are correctly mounted and securely fixed. Check the mechanical stability of the entire system. WARNING! n Load the optional infusion pole evenly. Check that the pole clamps are tightened before use and after height adjustment. n Switch the master switch "Console" off before maintaining, cleaning, preparing, storing or replacing modules. WARNING! n Do not use the machine in the event of problems with the guide rollers for tubing as otherwise the tube could be damaged. n Only use the optional lamp which is available as an accessory. Do not operate more than one lamp.

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| HL 20 | 2 Safety | 17 |

WARNING! n Observe the ROTAFLOW Console Instructions for Use. n The ROTAFLOW Console should only be used with a retrograde flow safety valve or other adequate systems or methods (e.g., two tube clamps), which prevent a backflow. n Do not use the ROTAFLOW System as a suction device in the area of operation. n The Emergency Drive can be used to manually drive the centrifugal pump if the ROTAFLOW Console should fail. WARNING! n Do not touch the sockets of the modules and pumps. This could otherwise result in damage due to electrostatic charging and moisture. n Keep the rear flap of the base console closed in order to protect the electronics. 2.2.4 General Precautionary Measures During Use WARNING! n Use the system and accessories in accordance with the Instructions for Use and tried and tested medical practice. n It is the operator's responsibility to ensure that the system is used, tested and maintained in accordance with all updates of the product specification and Instructions for Use. n During use, the system, extracorporeal circulation, and reservoir must be continuously monitored by the intended user (⇨ "Intended User", page 11). n 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. n Pay attention to the minimum and maximum approved values of the disposable for blood flow and pressure (⇨ Disposable's Instructions for Use). n Avoid extreme and sudden changes in the flow rate, especially during pulsatile pumping. n Keep clamps ready to prevent a possible air embolism in the patient caused by rising air during a pump stop n Always keep a hand crank to hand during the treatment. n The hand crank can be used to drive the pump manually if the HL 20 should fail. Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| 18 | 2 Safety | HL 20 |

WARNING! n Do not touch the patient and the external interfaces of the device at the same time. n Do not bend or clamp the tube while the pump is running to avoid damage to blood and cavitation. n If the arterial pump stops inadvertently, hypovolemia may occur. To avoid this, close the venous clamp or leave it closed. n If a roller pump with insufficient occlusion or the ROTAFLOW Centrifugal Pump stops, flow reversal may occur. To avoid this, clamp or occlude the vascular accesses. n The use of silicone pump tubes in roller pumps can lead to spallation and an inflammatory response. n To avoid unintentional venous drainage when using a venous clamp quick or venous clamp standard, an additional tube clamp should be applied to the venous line. n Reset the fuse of the HL 20 if the power consumption is too high, e.g., due to blocked pumps. WARNING! To avoid the potential for air embolisms when using a microporous membrane oxygenator, the pressure on the blood side should always be higher than that on the gas side of the membrane. The user must, among other things, observe the following precautionary measures: n Do not exceed the specified gas flow. n Do not occlude the gas outlet of the oxygenator. n Do not affix the oxygenator above the level of the reservoir or the patient. n Do not open clamps upstream and downstream of a centrifugal pump when at high rpm. 2.2.5 External Devices If the system is made up of several devices, the operator is responsible for ensuring system safety. WARNING! n Check that all devices comply with IEC 60601-1. n Check that all devices connected to the digital interface of the system satisfy the IEC standards (IEC 60950 for data processing equipment located more than 1.5 meters from the operating table and IEC 60601-1 for data processing equipment within 1.5 meters of other medical devices). Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| HL 20 | 2 Safety | 19 |

Patient Monitoring WARNING! The following vital parameters of the patient must be monitored by an external monitoring system and the intended user during use (⇨ "Intended User", page 11): n Continuous measurements: - Central venous pressure - Verified temperature measurement - Arterial pressure - ECG n Regular measurements: - Activated clotting time (ACT) - Blood gas analysis n Regular measurements for applications which last more than 6 hours: - Antithrombin 3 - Partial thromboplastin time (PTT) n In addition, the following continuous measurements are recommended: - Pulmonary arterial pressure (PAD) - Venous oxygen saturation - Hemoglobin - Hematocrit Pressure Monitoring WARNING! When using the pump modules of the HL 20, the pressure in the extracorporeal circuit can increase to dangerous levels. n Only use the HL 20 with activated pressure monitoring which triggers an alarm or intervention as necessary.

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG

| 20 | 2 Safety | HL 20 |

Bubble Monitoring WARNING! n Only use the HL 20 with activated bubble monitoring which triggers an alarm or an intervention when bubbles are detected. n Install the bubble monitoring system according to the instructions. n An arterial filter is no replacement for bubble monitoring. Use more than one procedure to prevent bubbles developing. The responsibility for taking precautions lies with the user. n When the intervention is activated, the detection of bubbles by the bubble sensor causes the pump to stop. Micro bubbles ≤ 5 mm can also cause the pump to stop. n The pump starts again when the user actively resets the bubble alarm. During the intervention, the blood flow will be interrupted and supply to the patient will cease. Whilst the pump is stopped, a backflow may occur. n Ensure that an intended user (⇨ "Intended User", page 11) is always present and able to respond to a bubble alarm immediately, remove the cause and reset the bubble alarm. n Prevent large movements and strain on the tube during perfusion in order to ensure the functioning of the sensor. n Only start the application if bubble monitoring is fully functional. Before each use, perform a function test together with the oxygenator filled with liquid (Bubble Detection: Function Test). NOTE A bubble stop malfunction may occur with initially imperfect mixing of blood and priming liquid due to a difference in the acoustic properties of the fluids.

Instructions for Use | 3.2 | EN | 10 Copyright MAQUET Cardiopulmonary AG