HU 35 HEATER UNIT Users Manual March 2017

Validity of this document This document is valid for the 230 V version from serial number 90031800 and for the 115 V version from serial number 90034500.

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

| HU 35 | Content | 3 |

Content 1

2

General ...5 1.1

Information on these Instructions for Use ...5 1.1.1 Symbols ...5 1.1.2 Definitions ...5

1.2

Environmental Protection...6 1.2.1 Packaging ...6 1.2.2 Disposal ...6

1.3

Abbreviations ...6

Safety ...8 2.1

Intended Use...8

2.2

Intended User ...8

2.3

Intended Use Environment ...8

2.4

Intended Patient...8

2.5

Indication...8

2.6

Contraindications ...8

2.7

General Safety Instructions...9 2.7.1 General Risks When Using the Device ...9 2.7.2 Position of Use and Operation and Positioning of the Device ...9 2.7.3 Handling the Device ...10

2.8

Electromagnetic Compatibility...10

2.9

Symbols ...11

2.10 Rating Plate ...14 3

4

5

System Description ...15 3.1

System Definition ...15

3.2

System Overview ...15

Preparing Application ...17 4.1

Setting Up the HU 35 ...17

4.2

Filling the HU 35 with Water ...19

4.3

Connecting Tubes and Oxygenator ...21

4.4

Switching On the HU 35...22

4.5

Changing the Display Language...23

During the Application ...25 5.1

Checking Function and Safety ...25 Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| 4 | Content | HU 35 |

5.2

Setting Temperature ...25

5.3

Checking Heat Emission...25

5.4

On completion of the application...26

6

Troubleshooting ...27

7

Messages...28

8

9

7.1

High-Priority Alarms ...28

7.2

Power Failure Alarm ...30

Cleaning and Disinfection ...31 8.1

Surface Cleaning and Disinfecting the Device after Each Use ...31

8.2

Descaling and disinfection of the water circuit ...32 8.2.1 Descaling Process for HU 35 ...37 8.2.2 Disinfection Process for HU 35...41 8.2.3 High Level Disinfection and Biofilm Removal Process for HU 35...45

Maintenance...49 9.1

Maintenance by the Operator ...49 9.1.1 Checking Ventilation Slots ...50 9.1.2 Maintaining Tube Couplings ...50

9.2

Inspection and Maintenance by Authorized Service Personnel...50 9.2.1 Inspection ...50

9.3

Repair ...50 9.3.1 Send Device to Authorized Service Point ...50

9.4

Authorized Service...50

10

Accessories...51

11

Technical Data ...52

12

Applied Standards...54 12.1 Safety Information...54 12.2 Electromagnetic Compatibility (EMC) ...54

13

Brief Instructions ...58

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| HU 35 | 1 General | 5 |

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 The type of risk and how it can be prevented are described in the text of the safety instructions. 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.

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| 6 | 1 General | HU 35 |

CAUTION! Identifies a possible risk which can result in injury. 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

AC

Alternating current

DC

Direct current

HLS

Heart Lung Support System

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| HU 35 | 1 General | 7 |

HU

Heater Unit

PLS

Heart and/or lung support system (Permanent Life Support)

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| 8 | 2 Safety | HU 35 |

2 Safety 2.1 Intended Use The HU 35 acts as a heat supply in order to maintain the patient's body temperature via a heat exchanger of a PLS Oxygenator or HLS Module or other oxygenator-heat exchangers as part of extracorporeal circuits.

2.2 Intended User The device may only be operated by trained medical staff experienced in extracorporeal circulation.

2.3 Intended Use Environment The device is intended to be used at intensive care units only.

2.4 Intended Patient The device can be used for all patients irrespective of age, body weight and gender.

2.5 Indication The HU 35 is indicated to be used in extracorporeal circuits with a oxygenator heat exchanger, in particular with a PLS Oxygenator or HLS Module. The device is intended to be used as part of ECMO/ECLS applications only.

2.6 Contraindications No contraindications are known if the device is used for the intended use and in accordance with the stated operating conditions.

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| HU 35 | 2 Safety | 9 |

2.7 General Safety Instructions 2.7.1 General Risks When Using the Device WARNING! n The power supply of the HU 35 must be protected by a ground fault circuit interrupter (GFCI/RCD). n You should always keep a replacement unit on standby in order to ensure continuous operation in the event of a complete system failure, and to maintain the patient's body temperature. 2.7.2 Position of Use and Operation and Positioning of the Device WARNING! n If possible, operate the HU 35 more or less at the same height as the oxygenator due to the water pressure. The HU 35 must not be operated at more than 1 m above or below the oxygenator. n Do not connect units that are not part of the system to the HU 35. n Operate the HU 35 only in a horizontal position. It must be placed on a surface or installed in an arrangement that is stable, secure and able to support the weight. n There must be a clearance of at least 20 cm behind the HU 35 and also sufficient space above it, to ensure adequate ventilation. Ensure that the ventilation slots on the bottom and rear are not covered. n Observe the ambient conditions. (⇨ "Technical Data", page 52). n Consider the electromagnetic compatibility and take special precautionary measures in this regard (⇨ "Electromagnetic Compatibility", page 10). n Do not spray the unit with liquids. n Do not operate the HU 35 in the presence of flammable gases. n Do not position any other electronic equipment on or next to the HU 35. If this cannot be avoided, check before use that the HU 35 is functioning normally. n Do not operate the HU 35 close to heat sources (spotlights, direct sunlight, heating elements, radiant heaters, etc.). n Observe the information on transportation of the unit. n Switch off the unit and remove all cable connections prior to intra-hospital transportation. n Defective cables must be replaced immediately.

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| 10 | 2 Safety | HU 35 |

2.7.3 Handling the Device WARNING! n The output of the HU 35 is designed to maintain the body temperature of a patient. Active warming or cooling is not possible. n The maximum water temperature of the HU 35 is 40°C. n Do not use the unit if the temperature gradient between the body temperature of the patient and the water outlet temperature of the HU 35 is > 8°C. n Before putting into operation, make sure that both the HU 35 (power cable, housing, couplings, etc.) and the applied part (oxygenator) are in proper working order. n Observe the automatic function test when switching on the unit and, if the unit is used continuously, carry out the test at least once daily. If the function test does not proceed as described, switch off the HU 35 and have it tested by authorized service personnel. n Check the flow and water level at the HU 35 prior to every use and at least every eight hours during continuous use. n Do not kink the tubes. Do not touch the tubes with pointed or sharp objects. n The oxygenator heat exchanger used must meet at least the following requirements: Water pressure: at least 0.75 bar Water temperature: not above 40°C n During the application, monitor the patient's body temperature and ECG using an external independent monitoring system. Monitor the blood temperature at the oxygenator. n Carry out maintenance in accordance with the chapter ⇨ "Maintenance", page 49.

2.8 Electromagnetic Compatibility In order to satisfy the essential performance criteria and therefore the intended use of the HU 35, the pump, motor and software must not fail during operation due to electromagnetic interference. The HU 35 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 typical clinical environment (Electromagnetic Compatibility (EMC))

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| HU 35 | 2 Safety | 11 |

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! Excessive electromagnetic interference may cause errors on the display. n Do not use the HU 35 in the vicinity of devices that emit high-frequency signals (e.g., cell phones or high frequency devices). These can cause excessively strong electromagnetic interference that exceeds the compliance level of the HU 35. n Do not position any other electronic equipment on or next to the HU 35 and its tubing. n Only use the accessories specified (⇨ "Accessories", page 51) as other accessories may cause increased electromagnetic stray radiation or reduce the immunity to interference of the HU 35. No accessories have been specified for the HU 35 that could disrupt electromagnetic compatibility or reduce immunity to interference according to 60601-1-2 when used with other medical devices.

2.9 Symbols Notice! Observe the warnings and safety precautions given in the accompanying docu­ mentation. Warning: Dangerous voltage

Observe the instructions in the Instructions for Use!

Order number Serial number

Protection type in accordance with IEC 60529: Protection against vertically dripping wa­ ter Classification in accordance with IEC 60601­1: Type B applied part.

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| 12 | 2 Safety | HU 35 |

Alternating current Date of manufacture: Month­Year in which the device was made.

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

Top

Fragile

Do not expose to direct sunlight

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 product 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 requirements of Council Directive 93/42/EEC concerning medical products. Follow the Instructions for Use!

Equipotential bonding

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| HU 35 | 2 Safety | 13 |

Fuse Protective ground

Water level indicator: Maximum marking

Water level indicator: Minimum marking

Alarm lamp

Actual temperature display

Setpoint temperature display

Flow display

"Function test" key

"Alarm tone break" key

"Increase setpoint temperature" key

"Decrease setpoint temperature" key

Release key for setpoint temperatures above 38°C

On/off switch

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| 14 | 2 Safety | HU 35 |

2.10 Rating Plate The rating plate is located on the rear of the HU 35. Rating plate HU 35 115 V

1 2 3 4 5 6 7

Order number Device­specific serial number UDI code Device­specific date of manufacture Power consumption Mains frequency Power supply

1 2 3 4 5 6 7

Order number Device­specific serial number UDI code Device­specific date of manufacture Power consumption Mains frequency Power supply

Rating plate example

Rating plate HU 35 230 V

Rating plate example

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| HU 35 | 3 System Description | 15 |

3 System Description 3.1 System Definition The warming unit HU 35 works on the principle of heat conduction to the blood stream via the impervious membrane of an oxygenator. In the HU 35, water is heated up in a water tank. This water is electronically regulated and pumped continuously by a centrifugal pump. The HU 35 has self-closing couplings so that tubes can be connected and disconnected while the unit is in operation. The setpoint temperature can be set to between 35°C and 39°C, enabling the body temperature to be maintained. The HU 35 monitors the internal water level, the difference between setpoint temperature and actual temperature of the water circuit, the external power supply and operational safety. It generates alarms in the event of malfunctions. Various displays on the front of the HU 35 indicate the status.

3.2 System Overview

1 2 3 4 5 6 7 8 9 10 11

Water level indicator Alarm lamp Status display Actual temperature display Buttons Flow display On/off switch Coupling pair for tube connections Not used Setpoint temperature display Threaded holes for optional clamp mounting

Front

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| 16 | 3 System Description | HU 35 |

1

2

3

4

5 6 8 Rear

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

7

1 2 3 4 5 6 7 8

Outflow point with screw cap Ventilation slots Filler neck with screw cap Rating plate Equipotential bonding pin Line fuses Connector plug for power cable Threaded holes for optional clamp mounting

| HU 35 | 4 Preparing Application | 17 |

4 Preparing Application WARNING! Danger to life due to the combination of water and electricity. n Fill the HU 35 with water before connecting the HU 35 to the external power supply.

4.1 Setting Up the HU 35 WARNING! Please note the requirements regarding position of use and positioning of the HU 35 (⇨ "Position of Use and Operation and Positioning of the Device", page 9 ). Table-top operation The HU 35 is designed for use on a table top. It can be placed on any flat, horizontal, hard surface that can support the weight. For safety reasons, do not operate the HU 35 on the floor.

WARNING! When used on the SPRINTER CART or on the SPRINTER CART XL, the fixing of HU 35 must be used.

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| 18 | 4 Preparing Application | HU 35 |

Operation on SPRINTER CART The HU 35 can be operated on the SPRINTER CART from Maquet (⇨ SPRINTER CART Instructions for Use). For this you require a clamp mounting ( ⇨ "Accessories", page 51).

Operation on SPRINTER CART XL The HU 35 can be operated on the SPRINTER CART XL from Maquet (⇨ Instructions for Use SPRINTER CART XL). For positioning, you need the extendable shelf for hyperthermia devices (⇨ "Accessories", page 51).

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| HU 35 | 4 Preparing Application | 19 |

Wall mounting on slide rail The HU 35 can be attached to standard slide rails (25 × 10 mm). For this you require a clamp mounting (⇨ "Accessories ", page 51). 1 Secure the clamping mount to the rear of the HU 35 using two screws. 2 Fasten the HU 35 to the rail using the star screw of the clamp mounting.

Tubing holder (optional) You can attach the optional tubing holder to the right-hand side of the HU 35 using the knurled screws located there.

4.2 Filling the HU 35 with Water Checking the water level WARNING! The indicated water level must be between the minimum and maximum markings, and preferably at or near the maximum marking. The difference between the two markings is 0.7 liters. Check the water level before switching on the HU 35 and connecting the tubes. Top up the water under any of the following conditions: Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH

| 20 | 4 Preparing Application | HU 35 |

n The water level is below the minimum marking. n The status display shows [WATER LEVEL!?] or [TEMP >= 40]. n The water level is below the maximum marking and the tubes and the oxygenator have not been filled. Filling with water WARNING! The HU 35 tank shall be filled with sterile filtered water with a water hardness of ≤ 14 °dH (2.5 mmol/l CaCO3). Do not use deionized water. WARNING! n If water overflows when filling the HU 35, dry the HU 35 thoroughly. The HU 35 must be completely dry before you connect it to the external power supply and switch the HU 35 on. WARNING! The HU 35 is not a sterile device. CAUTION! Change the water at least every two weeks (⇨ "Maintenance by the Operator", page 49). 1 2 3 4

Switch off the HU 35 and disconnect the HU 35 from the power supply. Unscrew the filler neck screw cap (e.g., using a coin). Make sure that you do not lose the cap's sealing ring. Fill the HU 35 with water until the water level is just below the maximum marking. Maquet recommends using a funnel. De-air the system.

De-airing the system 1 2

3

4

Unscrew the filler neck screw cap (e.g., using a coin). Make sure that you do not lose the cap's sealing ring. Make sure that the HU 35 is completely dry and the ends of the hoses are connected to the cleaning connector (double Hansen coupling). Connect the HU 35 to the power supply and switch the HU 35 on. Let the HU 35 run with the filler neck open for two minutes so that air in the circuit can escape. NOTE: After de-airing, air bubbles may be visible in the flow display. This does not mean that there are air bubbles in the tube system. Put the cap back onto the filler neck and screw it hand-tight.

Instructions for Use | 5.1 | EN | 05 Copyright Maquet Cardiopulmonary GmbH