HCU 40 HEATER-COOLER UNIT Instructions for Use Rev 1.1 sw rel 1.2.1.0 or higher Dec 2018

Validity of this document Revision 1.1, issue date 2018-12 This document applies to the device HCU 40 with software release 1.2.1.0 or higher. Documents for lower software releases do not apply to the device HCU 40 with software release 1.2.1.0 or higher.

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 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. Manufacturer Maquet Cardiopulmonary GmbH Kehler Strasse 31 76437 Rastatt GERMANY Phone: +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com

| HCU 40 | Contents | 3 |

Contents 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 Disposal ...9

1.3

Abbreviations ...9

Safety ...11 2.1

Intended Use ...11 2.1.1 Indications ...11 2.1.2 Intended Use...11 2.1.3 Intended User...11 2.1.4 Intended Patient ...12 2.1.5 Intended Environment ...12 2.1.6 Contraindications ...12

2.2

General Safety Instructions ...12 2.2.1 Precautionary Measures ...12 2.2.2 Position of Use and Operation and Positioning of the HCU 40...12 2.2.3 Handling the HCU 40 ...13 2.2.4 Water Circuits and Heat Exchangers ...14 2.2.5 Monitoring and Sensors ...15 2.2.6 Extended Applications...16 2.2.7 Electromagnetic Compatibility...16

2.3

Symbols ...17

2.4

Rating Plates ...19

System Description...21 3.1

How the HCU 40 Functions ...21

3.2

System Overview ...22

3.3

Water Circuit Controls...23

3.4

Controls for Electrical Connections...23 3.4.1 Status of the On/Off switch ...23

3.5

Control Unit CU...24 3.5.1 Rotary Knob with Button Function...24 3.5.2 Touchscreen ...24

3.6

Touchscreen, Display Areas ...24 Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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3.6.1 3.6.2 3.6.3 3.6.4 3.6.5

Status Bar ...25 Toolbar ...26 "Warming" and "Cooling" Hotkeys ...26 Parameter Display...27 Pump Control ...28

3.7

Main Screen...28

3.8

Functions ...29 3.8.1 De-airing the Circuits...30 3.8.2 Emptying Tubes ...31 3.8.3 Compressor Control ...31

3.9

Settings ...32 3.9.1 System Settings ...33

3.10 Pausing the Current Alarm ...34 3.11 Basic Handling Information for Software ...34 3.11.1 Confirming or Rejecting Inputs/Changes ...34 3.11.2 Switching Functions On and Off...35 3.11.3 Changing Numerical Settings...35 3.11.4 Using a Selection List...36 3.11.5 Using a Wizard...36 3.11.6 Locked Controls ...36 4

Operation ...38 4.1

Positioning and Connecting the Device ...38 4.1.1 Setting up and Connecting the HCU 40 ...38 4.1.2 Connecting a Control Unit ...39 4.1.3 Connecting External Devices (Optional) ...39 4.1.4 Connecting External Temperature Sensors (Optional) ...39 4.1.5 Securing Set of Slide Rails for Tubing Holder (Optional) ...40 4.1.6 Opening/Closing Stopcocks ...40 4.1.7 Filling/Topping Up Water...41 4.1.8 Connecting/Removing Water Tubes ...42

4.2

Using the System...43 4.2.1 Switching On the HCU 40, Self-Test...43 4.2.2 Setting and Changing Setpoint Temperatures ...45 4.2.3 Starting/Stopping Circulation...46 4.2.4 Using Hotkeys ...47 4.2.5 Setting the Warning Limits for the External Temperature ...47 4.2.6 Gradient Mode ...49

4.3

Water Circuits ...52 4.3.1 Creating a Water Circuit...52

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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4.3.2 4.3.3 4.3.4

5

4.4

System Configuration ...59 4.4.1 Changing the Hotkey Settings...59 4.4.2 Changing the Setpoint Ice Block Size ...60 4.4.3 Changing the Water Flow...61 4.4.4 Changing the Settings for Locking the Controls...62 4.4.5 Changing the Brightness/Volume...62 4.4.6 Changing the Time, Date and Formats ...63 4.4.7 Changing the Display Language ...65

4.5

System Information ...65 4.5.1 Displaying the Tank Status ...65 4.5.2 Displaying the Ice Block Size ...66 4.5.3 Displaying the Pressure Limits...68 4.5.4 Testing the Functioning of the Speaker and Warning Buzzer...68 4.5.5 Testing Alarm Functions ...69 4.5.6 Cleaning/Emptying System Status...69 4.5.7 Displaying the Power Supply Status ...69 4.5.8 Displaying System Information...70

4.6

Putting into Operation ...71 4.6.1 Before First Use ...71 4.6.2 Check Before Every Application...71 4.6.3 During the Application ...72 4.6.4 On Completion of the Application...73

4.7

Emergency Procedures ...73 4.7.1 De-airing in an Emergency During Perfusion...74

4.8

Key User Functions ...75 4.8.1 Calling Up the "Service" Screen...75

Troubleshooting ...77 5.1

6

Connecting a Heat Exchanger ...52 De-airing the Circuits...56 Emptying Water Circuits...58

Causes of Faults and Measures to Take ...77

Messages ...80 6.1

Alarms...80 6.1.1 Duration and Intervals for Acoustic Alarms ...80

6.2

Alarm List ...80

6.3

Physiological Alarms...81 6.3.1 Medium Priority ...81

6.4

Technical Alarms ...81 Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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6.4.1 6.4.2 6.4.3 6.5 7

8

High Priority...82 Medium Priority ...83 Low Priority ...86

Messages ...89

Cleaning, descaling and disinfection ...90 7.1

Surface Cleaning and Disinfecting the Device after Each Use ...90

7.2

Descaling and disinfection of the water circuits ...91 7.2.1 Performing Descaling...93 7.2.2 Performing weekly routine disinfection...104 7.2.3 Performing highly effective disinfection and biofilm removal...114 7.2.4 Emptying the Tank ...123

7.3

Cleaning the Air Filter ...126

Maintenance ...127 8.1

Maintenance by the Operator ...127 8.1.1 Daily Inspection by the Operator...127 8.1.2 Perform Diagnosis...127

8.2

Inspection and Maintenance by Authorized Service Personnel...129 8.2.1 Inspection...129 8.2.2 Maintenance...129

8.3

Repair ...130 8.3.1 Send Device to Authorized Service Point ...130

8.4

Authorized Service...130

9

Initial Installation ...131

10

Accessories ...132

11

Technical Data...134 11.1 HCU 40 Device ...134 11.2 Control Unit CU...135 11.3 Permissible Heat Exchangers...135 11.3.1 Oxygenator and Cardioplegia Heat Exchangers...135 11.3.2 Blanket Connection Kit (incl. Pressure Reducer) ...136 11.4 Components Supplied ...136 11.5 Ambient Conditions...136 11.6 Measured Data and Displayed Data ...137 11.7 Possible Settings and Factory Settings ...137 11.7.1 Temperatures and Water Flows...137 11.7.2 Accuracy of the Temperature Control ...138

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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11.7.3 Hotkeys ...138 11.8 Availability of Physiological Alarms for External Devices ...139 11.9 Essential Performance Characteristics ...139 11.10 Solution Concentration with Different Tube Lengths ...140 11.10.12 per cent citric acid concentration for descaling various tube lengths 140 11.10.22 per cent Chloramine-T concentration for weekly routine disinfection of various tube lengths ...140 11.10.35 per cent Chloramine-T concentration for highly effective disinfection and biofilm removal of various tube lengths...141 12

Applied Standards ...142 12.1 Electromagnetic Compatibility (EMC) ...142

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

| 8 | 1 General | HCU 40 |

1 General 1.1 Information on these Instructions for Use These Instructions for Use will familiarize you with the features of the Maquet device. 1.1.1 Symbols References References to other pages in these Instructions for Use begin with the arrow sign "⇨". Action and reaction The operator's actions are identified with numbered paragraphs "1", while the "▶" symbol identifies the reaction triggered in the system. Example: 1 Switch the light switch on. ▶ The lamp lights up. 2 Switch the light switch off. 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 | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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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 Disposal To ensure optimal utilization of the raw materials, the device 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

CAN

Controller Area Network

CPLG

Cardioplegia

CU

Control unit

HCU

Heater-cooler unit

HF

High frequency

Text

Temperature measured at the external sensor

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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Tout

Temperature measured at the water outlet

Tset

Setpoint temperature

Ttank

Temperature measured in the tank

USB

Universal serial bus

ΔT

Setpoint gradient

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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2 Safety 2.1 Intended Use NOTE Heat exchanger Please observe the Instructions for Use for the employed heat exchangers with regard to the indications, intended use, intended user, intended patient, intended environment, and contraindications. 2.1.1 Indications The intended purpose of the heater-cooler unit HCU 40 is cooling and warming a patient and maintaining the patient temperature at the required level during cardiovascular interventions. Temperature changes are effected by means of a combined oxygenator with heat exchanger in the extracorporeal perfusion circuit. The system comprises two separate water circuits with temperature regulation. The first circuit is for connecting the oxygenator heat exchanger and/or the warming/cooling blanket; the second circuit is intended for connecting the cardioplegia heat exchanger. Heat exchange between the patient and the cardioplegic fluid occurs by the temperature-regulated water flowing through the heat exchanger and/or the warming/cooling blanket. The water temperature of the patient water circuit and the cardioplegia water circuit can be regulated independently of each other. The water temperature can be set between 1°C and 40.5°C. External temperature sensors can be optionally combined with the HCU 40, and can be used to operate the HCU 40 in gradient mode. The purpose of this mode is to provide physiologically optimized warming and cooling of the patient. 2.1.2 Intended Use The heater-cooler unit HCU 40 is intended for cooling or warming a patient connected to the extracorporeal perfusion circuit and keeping the required patient temperature constant. The temperature transfer occurs via a heat exchanger in the patient perfusion circuit and/or cardioplegia water circuit and/or via a warming/ cooling blanket. 2.1.3 Intended User The HCU 40 may only be operated by trained specialist medical staff.

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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2.1.4 Intended Patient The device can be used for all patients irrespective of age, body weight and gender. 2.1.5 Intended Environment The HCU 40 is used in a clinical environment. 2.1.6 Contraindications When the heater-cooler unit HCU 40 is used by specially trained personnel under the supervision of a physician and in compliance with the intended use, no contradictions are to be expected.

2.2 General Safety Instructions 2.2.1 Precautionary Measures WARNING! n The system must be monitored by a trained member of specialist medical staff. Clinical procedures and methods are the responsibility of the physician. 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 Prior to using the system, please read these Instructions for Use and the Instructions for Use of all the disposables and supplies used. n The HCU 40 and all the system components used must comply with the requirements of IEC 60601-1: 2005, section 16. In case of doubt, contact the manufacturer of the system components used. WARNING! n It is not permitted to change or modify the device or its accessories. n Switch the unit off and disconnect it from the external power supply before maintenance, cleaning, or storage. n Only use the stated substances for descaling/disinfection (⇨ "Cleaning, descaling and disinfection", page 90). n If a defective warming/cooling blanket is used with an electrosurgical unit which is either not grounded or incorrectly grounded, this may result in burns to the patient (⇨ "Connecting a Heat Exchanger", page 52). 2.2.2 Position of Use and Operation and Positioning of the HCU 40 The HCU 40 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 HCU 40 is not interfered with by other devices or vice versa. Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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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 touchscreen of the HCU 40 as well as any optical warning signals at all times. In noisy environments, there is a risk that acoustic warning signals emitted by the HCU 40 may not be heard. n Do not use the system in the presence of escaping flammable or combustible gases. n Only operate the HCU 40 within the specified ambient conditions (⇨ "Ambient Conditions", page 136). Ambient temperatures outside of the specified conditions can disrupt the sensors' measurements. n Whenever the device is moved, the mains voltage must be checked by personnel authorized for this purpose. In the event of any extreme difference in voltage from the rated voltage (lower/higher: see rating plate), adjustment may be carried out by authorized service personnel. WARNING! n Only attach the intended components to the HCU 40. Otherwise, the limits of the safe workload may be exceeded and the mechanical stability of the HCU 40 may be affected. n The standard slide rail on the rear of the HCU 40 has a maximum load capacity of 15 kg. Ensure that you do not exceed this load limit. n All connected parts, devices, and modules must be firmly and correctly connected. Check mechanical stability. n Ensure that the speaker openings are not covered. There is a risk that acoustic warning signals may not be heard. n Make sure that the ventilation openings are not obstructed and the HCU 40 is not covered. There is a risk that the HCU 40 will overheat and fail. Ensure a minimum distance of 50 cm from other devices, objects, or the wall. 2.2.3 Handling the HCU 40 WARNING! n During an application, only use devices and equipment which are functioning perfectly. n Do not connect equipment which does not form part of this system. n Do not touch the touchscreen with sharp or pointed objects. n Only use the approved liquids as per the Instructions for Use in and on the HCU 40. Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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n Do not touch the plugs of the HCU 40 as electrostatic charges and moisture may cause damage. n Do not disconnect any plugs or cables from the HCU 40 or the control unit (CU) during operation. n If the CAN connection cable between HCU 40 and control unit (CU) is not connected during operation, immediately reconnect the cable (⇨ "Connecting a Control Unit", page 39). n If a cable proves to be defective, replace it with a cable which functions correctly. n If a plug is faulty, do not operate the device. n If the touch screen of the control unit (CU) does not display anything or fails to react, the CU must be reset. Disconnect and reconnect CAN connection cable between HCU 40 and CU. Check the set values. n If, during a power failure, no visual or acoustic alarms are emitted by the HCU 40, it is possible that the independent power supply (UPS) is defective. Have the device checked/repaired by authorized service personnel. Use a replacement device in an emergency. 2.2.4 Water Circuits and Heat Exchangers WARNING! n Switch the device off before intra-hospital transportation. Remove all connected cables. n Observe the shipping information (⇨ "Send Device to Authorized Service Point", page 130). WARNING! n Observe the Instructions for Use for the heat exchangers employed. n Observe the permissible values for heat exchangers (⇨ "Permissible Heat Exchangers", page 135). n The pressure limit must be set by the authorized service personnel in accordance with the permissible pressure of the heat exchangers. Have the pressure limit adjusted by the authorized service personnel if you use other heat exchangers with a lower permissible maximum pressure than the set pressure limit. n Use the HCU 40 and heat exchanger at the same height in order to avoid an increase in pressure between the HCU 40 and the heat exchanger. n The water tank must only be filled with sterile filtered water and other substances which have been specified by Maquet. n Check all water tubes and tube connections for leaks prior to the application.

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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n Keep the tubes away from sources of heat. n The length of the tube from the HCU 40 to the heat exchanger must be at least 1 m. WARNING! n Turn the cardioplegia water circuit pump off if no cardioplegic solution is required. n If the tubes are not connected to a heat exchanger, connect the ends of the tubes to the cleaning connector. 2.2.5 Monitoring and Sensors WARNING! n The water quality can influence the ice sensors which, in turn, can influence ice formation. Perform a visual inspection of the actual ice size and adjust the setpoint ice block size should the actual ice size differ from the setpoint size. n The following parameters must be monitored continually by an independent monitoring and alarm system during application. - Temperature of the patient - Blood temperature in the perfusion system - Contact surface temperature of the warming/cooling blanket n The external temperature sensors are intended for operating the HCU 40 in gradient mode. They must not be used for measuring the patient's core body temperature, and their use does not replace independent, external monitoring of the blood temperature in the perfusion system. n The precision of external temperature measurement depends on the temperature sensor and the disposable. n External temperature sensors must not be autoclaved. n Only use the external temperature sensors, with shielding, listed under "Supplies" for the HCU 40. n When operating the unit in gradient mode, the user can set temperature limits. An alarm is given if the temperature either falls below or exceeds the limit value. n The temperature limits must be set on the basis of physiological criteria. n If an alarm occurs, the setpoint and actual temperatures of the water and the patient's temperature must be checked. n After data have been input by the user, the HCU 40 must not be switched off immediately, as saving the data may take up to 10 seconds.

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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2.2.6 Extended Applications WARNING! While performing longer normothermal applications, avoid abrupt hypothermia, which could endanger the patient's health, by employing the following measures: n Do not add any ice; n Deactivate the ice formation or do not use any ice (⇨ "Changing the Setpoint Ice Block Size", page 60). 2.2.7 Electromagnetic Compatibility In order to satisfy the essential performance criteria and therefore the intended use of the HCU 40, the pump, motor and software must not fail during operation due to electromagnetic interference. If the essential performance features are limited or fail, the HCU 40 can no longer provide temperature-regulated water. The HCU 40 complies with the requirements of the IEC 60601-1-2 standard on electromagnetic compatibility. The system and all accessories and sensors fulfill the EMC requirements of a professional healthcare facility (⇨ "Electromagnetic Compatibility (EMC)", page 142). The HCU 40 can be used in the industrial sector and in clinics. When used in domestic establishments, the HCU 40 may not provide adequate protection of radiocommunication services due to its emissions. If necessary, the user must take corrective action, e.g., placing the HCU 40 at another installation location. The user is responsible for ensuring that the clinical environment complies with the limits prescribed in IEC 60601-1-2. Exceeding these limits may impair the system's efficiency and safety. WARNING! n Do not use the HCU 40 in the vicinity of devices that emit high-frequency signals (e.g., cell phones or HF surgical devices). These can cause excessively strong electromagnetic interference that exceeds the compliance level of the HCU 40. n Do not use the HCU 40 and its tubes directly next to, on or under other electrical devices. If this is unavoidable, monitor all devices continuously to ensure that they are operated properly. n Observe normal precautions regarding relative humidity and the electrical conductivity of clothing in order to minimize the build-up of electrostatic charges.

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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n To ensure safe use, the length of all connection cables of the HCU 40 must not be changed. n Only use the specified accessories (⇨ "Accessories", page 132). The use of other devices, systems, or accessories may increase RF emissions or reduce the immunity to interference.

2.3 Symbols Symbols on the rating plates of the HCU and control unit (CU) Notice! Observe the warnings and safety precautions given in the accompanying documentation. Warning: Dangerous voltage

Observe the instructions in the Instructions for Use!

Protection type in accordance with IEC 60529: Protection against ingress of solid foreign objects larger than 12.5 mm and dripping water when tilted up to 15°. Classification in accordance with IEC 60601-1: Type B applied part.

Alternating current Date of manufacture: Month-Year in which the device was made.

Manufacturer as defined by Directive 93/42/EEC concerning medical devices.

Top

Fragile

Do not expose to direct sunlight

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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Store in a dry place

Temperature restriction

Air humidity restriction

Air pressure restriction

Separate collection of electric and electronic devices in accordance with Directive 2012/19/EU: Do not dispose of the device with normal domestic waste. Keep separate from domestic waste and dispose of in an environmentally safe way in compliance with local regulations. The device meets the essential requirements of Directive 93/42/EEC concerning medical devices. 0124 is the number of the notified body involved (DEKRA Certification GmbH)

710165

The device meets Canadian and American safety standards. Tested by the Nationally Recognized Test Laboratory SGS North America, Inc. Follow the Instructions for Use!

Symbols on HCU "Control unit (CU)" connection

Patient water circuit 1

Patient water circuit 2

Cardioplegia water circuit

Water outlet

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

| HCU 40 | 2 Safety | 19 |

Water inlet (backflow)

Port for external power supply

Equipotential bonding

Symbols on the housing of the control unit (CU) "Text" connection for cardioplegia water circuit "HLM" connection (not used)

"HCU" connection

USB port "Text" connection for patient water circuit Symbols on the supply to the warming/cooling blanket Classification in accordance with IEC 60601-1: Type BF applied part

2.4 Rating Plates HCU 40 The rating plate is on the rear of the HCU 40. 1

2

6

5

4

3

1 2 3 4 5 6

Order number Device-specific serial number Device-specific date of manufacture Power consumption Frequency AC power supply Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

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The values on the rating plate shown are examples and may differ from the rating plate on the device. Control unit (CU) The rating plate is on the rear of the control unit (CU). 1

2

3

Instructions for Use | 1.1 | EN | 02 Copyright Maquet Cardiopulmonary GmbH

1 2 3

Order number Device-specific serial number Device-specific date of manufacture