Livanova 3T User Manual

Heater-Cooler System 3T Operating Instructions

Heater-Cooler System 3T • Operating Instructions

Tel.: +49/(0)89/32301-0 Fax: +49/(0)89/32301-555

All rights reserved, especially the right to reproduction and distribution as well as translation. No part of this document may be reproduced – by photocopy, microfilm or any other process – nor may any part of it be stored, edited, duplicated or distributed by electronic means without the written permission of LivaNova Deutschland GmbH.

Trademarks used in these operating instructions: The name “Stöckert®” is a registered trademark. Minncare® is a registered trademark of the Minntech Corporation, a Cantel Medical Company. Clorox® is a registered trademark of the Clorox Company. Pall-Aquasafe™ is a registered trademark of the Pall Corporation. CaviWipesTM and CaviCideTM are registered trademarks of Metrex Research, LLC.

Indications for use

The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Distributed in the U.S.A. by:

LivaNova USA, Inc. 14401 West 65th Way Arvada, CO 80004

phone: 800.221.7943 phone: 303.425.5508 fax: 303.467.6584

Operating Instructions Version 02/2020 - CP_IFU_16-XX-XX_USA_021

Firmware version No. 2.07

2 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Table of contents

Table of contents

1 Introduction 5

1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2 Safety 13

2.1 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3 System description 19

3.1 General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

3.2 Structure of the heater-cooler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

4 Preparing the heater-cooler for a procedure 33

4.1 General technical requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4.2 Conducting any required disinfection and maintenance . . . . . . . . . . . . . . . . . 36

4.3 Connecting the procedural tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

4.4 Connecting the potential equalization cable and the power supply . . . . . . . . 40

4.5 Connecting the aerosol collection set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

4.6 Connecting to the S5/C5 System (if applicable) . . . . . . . . . . . . . . . . . . . . . . . . 49

4.7 Filling and mixing water tanks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

5 Using the heater-cooler during a procedure 57

5.1 Positioning the heater-cooler in the OR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

5.2 Connecting the procedural tubing to external devices . . . . . . . . . . . . . . . . . . . 61

5.3 Powering on and checking the panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

5.4 Performing a functional check prior to operation . . . . . . . . . . . . . . . . . . . . . . . 68

5.5 Priming the complete circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

5.6 Using the device controls during a procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 74

5.7 Completing a procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

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Heater-Cooler System 3T • Table of contents

6 Maintaining the heater-cooler 91

6.1 General maintenance precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

6.2 Maintenance schedule and checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

6.3 Cleaning and disinfecting external surfaces, connectors, and fittings . . . . . . 99

6.4 Disinfecting the water circuits every 14 days . . . . . . . . . . . . . . . . . . . . . . . . . 104

6.5 Monitoring the tank water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

6.6 Changing the water and adding hydrogen peroxide . . . . . . . . . . . . . . . . . . . . 140

6.7 Preparing the heater-cooler for storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

6.8 Cleaning the heater-cooler interior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

6.9 Replacing the tubings once a year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

7 Technical specifications 153

7.1 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

7.2 Icons and labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

7.3 Part numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

7.4 Tested accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

7.5 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

7.6 Information on electromagnetic compatibility (EMC)

according to IEC 60601-1-2 (4th edition) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

8 Troubleshooting 175

8.1 Control panel warnings and error code displays . . . . . . . . . . . . . . . . . . . . . . . 176

8.2 Troubleshooting or returning the 3T Aerosol Collection Set . . . . . . . . . . . . . . 185

4 CP_IFU_16-XX-XX_USA_021

1 Introduction

This chapter provides an overview of the device, including indications for use and contraindications. This chapter also provides an explanation of each chapter, technical terms and symbols used in this operating manual, and a definition of the filtered water required for use in the heater-cooler.

CP_IFU_16-XX-XX_USA_021 5

Heater-Cooler System 3T • Introduction Introduction

1.1 Introduction

1.1.1 Device summary

The Heater-Cooler System 3T is an independent 3-circuit-heating/cooling system which is suitable for continuous use.

The heater-cooler has three circuits that you control from the control display panel:

● Cardioplegia circuit, whose temperature can be controlled from independent

heating and cooling tanks.

● Patient 1 circuit and patient 2 circuit, which can be used with the oxygenator

and/or the single-use heating/cooling blanket. The temperature for these two circuits can be controlled from one heating/cooling tank.

The heater-cooler is a non-sterile device. No part of the heater-cooler is provided sterile or can be sterilized.

Control panel

Cardioplegia circuit

Patient 1 circuit

C°C°C°

pascals

TANK VACUUM

100

CALIBRATED FOR VERTICAL POSITION

MAX

PRESS

URE

100

kPa

C°C°

° C

C°

° C

Patient 2 circuit

6 CP_IFU_16-XX-XX_USA_021

1.1.2 Indications for use

The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

1.1.3 Contraindications

There are no known contraindications for the Heater-Cooler System 3T. The attending physician is solely responsible for the use of the system.

1.1.4 Legal disclaimer

LivaNova Deutschland GmbH will not assume any liability for any injuries and/or damage to property caused by failure to observe the safety or operating instructions or by failure to exercise due care. This also applies even if the duty to exercise due care has not been expressly stated.

Heater-Cooler System 3T • Introduction

Introduction

1.1.5 About these operating instructions

● These operating instructions are intended for clinical and maintenance

personnel, and provide instructions for using, operating, and maintaining the Heater-Cooler System 3T.

● To ensure the safety of patients and the operators, read these operating

instructions thoroughly before using the heater-cooler for the first time.

● These operating instructions provide valuable information. They describe

operational steps and also contain information on how to avoid dangerous situations and errors. These operating instructions also provide troubleshooting instructions.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Introduction Introduction

1.1.6 Symbols used in these operating instructions

WARNING

Indicates a hazardous situation that, if not avoided, could result in death or serious injury.

CAUTION

Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.

NOTICE

Indicates a hazardous situation that, if not avoided, may result in damage to the device or other property.

Important

Indicates information considered important but not hazard related.

NOTE: Provides additional information that can help you better understand a specific instruction of function.

1 Checkmark: Used to indicate an item to check before or after completing a task.

These items are for reference and do not replace detailed instructions.

8 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Introduction

Introduction

1.1.7 The chapters in these operating instructions

1 Introduction

This chapter provides an overview of the device, including indications for use, contraindications. This chapter also provides an explanation of each chapter, technical terms and symbols used in this operating manual, and a definition of the filtered water required for use in the heater-cooler.

2 Safety

This chapter provides general safety information that you must follow to ensure safe and effective use. Additional safety information, such as Warnings and Cautions, are included throughout the instructions in this manual.

3 System description

This chapter describes the system’s features and components, and the controls that you will use to control the system’s circuits.

4 Preparing the heater-cooler for a procedure

This chapter provides instructions for preparing the heater-cooler for use.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Introduction Introduction

5 Using the heater-cooler during a procedure

This chapter provides instructions for positioning the heater-cooler in the OR and using the heater-cooler’s controls during a procedure. This chapter also provides the basic steps you will conduct after a procedure.

6 Maintaining the heater-cooler

This chapter provides instructions for the routine maintenance that is part of the operating conditions for the heater-cooler. This applies to the routine maintenance performed by the responsible organization as defined in IEC 60601-1 or the equivalent national standard, as well as to the preventive maintenance and safety checks performed by LivaNova representatives or competent service personnel.

7 Technical specifications

This chapter provides technical specifications including information about the heater-cooler’s physical characteristics, labeling, part numbers, accessories, and electromagnetic compatibility. This chapter also includes warranty information.

8 Troubleshooting

This chapter provides troubleshooting for warnings and error codes you might see on the control panel, and troubleshooting related to the aerosol collection set.

10 CP_IFU_16-XX-XX_USA_021

1.1.8 Terminology and abbreviations

Terminology

Abbreviated term Full term

Heater-cooler Stöckert Heater-Cooler System 3T S5 System Stöckert S5 System, modular heart-lung

machine

C5 System Sorin Compact 5 System, compact heart-

lung machine

Aerosol collection set 3T Aerosol Collection Set

Abbreviations

Heater-Cooler System 3T • Introduction

Introduction

Abbreviated term Full term

ACS Aerosol Collection Set 3T AL Allowable Limit CAN Controller Area Network (CAN bus)

cc Cubic centimeter (cm CFU Colony Forming Unit EMC Electromagnetic Compatibility EPA Reg. No. Registration number of the United States

Environmental Protection Agency (applies

to the United States only) HC3T Heater-Cooler System 3T HLM Heart-Lung Machine L Liters LPM Liters per minute mL Milliliters NTM Non-tuberculous Mycobacteria

)

OR Operating Room Pa Pascal kPa Kilopascal ppm Parts per million RF Radio Frequency UDI Unique Device Identifier

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Introduction Introduction

1.1.9 Requirement for filtered tap water

Tap water used to fill the heater-cooler must be filtered using the following filter and specifications:

Disposable Pall-Aquasafe water filter with an 0.2 μm membrane (Pall part reference in the U.S.: “AQINA”; “AQIN” in other countries) or a filter of equivalent performance that meets the requirements for bacterial retention of Brevundimonas diminuta to ≥ 10

For instructions on filter management and disposal after the specified use period please refer to the manufacturer’s instructions for use.

CFU/cm2 of effective filtration area.1

1 American Standard Test Method F838-15ae1 “Determining Bacterial Retention of Membrane

Filters Utilized for Liquid Filtration”

12 CP_IFU_16-XX-XX_USA_021

2 Safety

This chapter provides general safety information that you must follow to ensure safe and effective use.

Additional safety information, such as Warnings and Cautions, are included throughout the instructions in this manual.

CP_IFU_16-XX-XX_USA_021 13

Heater-Cooler System 3T • Safety Safety information

2.1 Safety information

2.1.1 General safety

● Read and understand the instructions for use before operating the heater-

cooler.

● Disinfect the external surfaces and water circuits per chapter 6 prior to first use.

● Do not place any objects (including the portable vacuum source) on top of the

heater-cooler.

● Maintain at least 70 cm clearance from walls and other devices while operating

the heater-cooler to prevent the heater-cooler from overheating.

● Do not operate the heater-cooler in the presence of explosive substances.

● Do not modify any of the mechanical or electrical systems of the heater-cooler.

● Do not remove the side or rear panels of the heater-cooler. Contact with the

internal components can cause serious injury or death.

● A list of approved accessory devices is contained in chapter 7. Do not use any

unapproved accessory devices with the heater-cooler.

● Do not use self-closing tubing connectors or connectors that incorporate a

valve. These connectors can reduce water flow to the external circuits.

● Drain heater-cooler water tanks outside the OR.

● Do not replace the aerosol collection canister in the OR environment.

● Avoid splashing heater-cooler water in the OR environment during use and

when making water circuit connections.

● Remove water spills from the OR floor using suitable disinfectants as

recommended by hospital procedures.

● Do not perform any maintenance activities while the heater-cooler is in use or

connected to an oxygenator or other heat exchanger device.

14 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Safety

Safety information

2.1.2 Information on diffusion of hydrogen peroxide through the oxygenator heat exchanger

The water in the heater-cooler contains approximately 330 ppm of hydrogen peroxide when prepared per these operating instructions. Contact the manufacturer of the disposable oxygenator for information specific to the hydrogen peroxide permeability of the heat exchanger for concentrations at or below this level.

Do not use the heater-cooler with disposable oxygenators that have a heat exchanger with a permeability rate that exceeds the daily allowable limit (AL) as defined in the following table:

Allowable mass of hydrogen peroxide

) in mg/day the can be transferred

202

in patient blood for:

Allowable limit (AL)

in mg/day per kg of Duration of exposure to H

Up to 6 hours 0.21 12.60 0.63

202

patient body

weight

An adult

(typical body weight is 60 kg)

A neonate

(typical body weight is 3 kg)

Over 6 hours 0.034 2.02 0.10

Although allowable limits (AL) for hydrogen peroxide diffusion are provided, actual performance may vary in individual cases. Monitor and manage all patients.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Safety Safety information

2.1.3 Procedural safety

● The heater-cooler does not monitor the temperature of the patient’s blood or

the cardioplegia solution.

● Do not empty the external circuits until the patient has been discharged from

the OR.

● LivaNova recommends always having a replacement heater-cooler available in

case the heater-cooler in use is no longer functional (e.g., due to a total system failure). The replacement heater-cooler must have compatible connectors.

2.1.4 Electrical safety

● Do not modify any of the electrical systems of the heater-cooler.

● The heater-cooler should only be connected to a hospital-quality power source

with an integrated protective conductor (ground).

● To avoid the risk of electric shock, the heater-cooler must only be connected to

a supply mains with protective earth.

● Check the condition of the power cable and plug regularly and do not use the

heater-cooler if the cable or plug shows signs of wear or damage.

● Do not position the heater-cooler where it will block access to the mains power

plug. Removing the mains plug from the receptacle isolates the heater-cooler from mains voltage and the plug must remain accessible at all times.

2.1.5 Integrating the HC3T into your facility

As part of the integration of the Heater-Cooler System 3T into your facility, LivaNova strongly recommends the following:

● Ensure that all operators and maintainers of the heater-cooler read the

instructions and familiarize themselves with the use and maintenance of the device (chapters 4, 5 and 6), with special emphasis on the critical tasks listed in the table below.

● Integrate all maintenance activities listed in chapter 6.2.1 into your facility’s

preventative maintenance scheduling system. This includes the cleaning and disinfection of the heater-cooler before first use. Failure to perform the maintenance tasks as indicated can lead to bacterial growth inside the device and an increased risk of exposing the patient to harmful bacteria.

● Implement regular bacterial sampling of the water in the heater-cooler into your

preventative maintenance scheduling system. This testing is critical to understanding if the disinfection and water preservation activities are being completed effectively. This testing can also indicate if an external source of contamination (e.g. a contaminated water hose) is present.

16 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Safety

Safety information

If you have any questions about the integration of the Heater-Cooler System 3T into your facility, please contact your LivaNova sales representative.

Human Factors Testing and clinical experience have shown that operators are most likely to have issues understanding or performing the critical tasks in the following table. This table provides the task description, where to locate the instructions related to this task, and the consequences of failing to perform the task correctly.

Task Location of

instructions

Do not use the HC3T without

Chapter 4.5 Failure to use the ACS may result in the

the ACS attached. Cap unused ports on the ACS. Chapter 4.5

Task 3,  3

Write the installation date on the ACS.

Replace the ACS after the disinfection procedure.

Clean and disinfect the HC3T

Chapter 4.5 Task 4,  7

Chapter 6.4.2 Task 11

Chapter 6.2.1 Bacteria may be present on or in the heater-

prior to first use.

Potential consequences of incorrect task performance or omission

emission of aerosol. Failure to cap the tandem and pour ports

may lead to a loss of vacuum in the ACS, potentially reducing the effectiveness in preventing the emission of aerosol.

Failure to write down the installation date can lead to use of the ACS beyond 7 days, potentially clogging the filter and reducing the effectiveness in preventing the emission of aerosol.

Failure to replace the ACS after the disinfection procedure could lead to disinfectant vapor entering the vacuum system.

cooler if the packaging was damaged during transport or storage.

Disinfect the connectors and tubing fittings prior to each connection.

Drain water tanks prior to adding disinfectant.

During disinfection, fill the water tanks to the Patient level second green LED after adding disinfectant.

Circulate disinfectant by pressing the WARM CP, Patient 1, and Patient 2 buttons.

Chapter 6.3.2 Chapter 6.3.3

Chapter 6.4.2 Task 2

Chapter 6.4.2 Task 4,  4

Chapter 6.4.2 Task 8,  1

Failure to disinfect the connectors and/or fittings could lead to bacterial growth that can be transferred to other parts of the heater-cooler or the OR.

Failure to drain the tanks prior to adding disinfectant could reduce the disinfectant’s effectiveness.

Failure to completely fill the tanks during disinfection could lead to a low level in one tank, potentially resulting in incomplete disinfection.

Failure to circulate disinfectant using Patient 1, Patient 2, and the WARM CP buttons could lead to incomplete disinfection of one or more tanks.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Safety Safety information

Task Location of

instructions

Do not use disinfectant during

Chapter 6.4.1 Use of disinfectant in the water during a

a procedure.

Mix chemicals (disinfectant or hydrogen peroxide) by connecting a tube between the INLET of the CP circuit and the INLET of the Patient 1 circuit.

Chapter 4.7 Task 3 & 4

Chapter 6.4.2 Task 6

Chapter 6.6 Task 4 & 5

Mix chemicals (disinfectant or hydrogen peroxide) using the COLD CP button.

Change the water in the heatercooler every 7 days.

Chapter 6.4.2 Task 6,  1 and Task 6,  2

Chapter 6.2.1 Section 6.6

Potential consequences of incorrect task performance or omission

procedure could lead to failure of the heater-cooler and the attached accessory devices.

Failure to properly connect the tubing prior to mixing could lead to one or more tanks not being exposed to the correct amount of the chemical, potentially reducing the effectiveness of the water preservation process.

Failure to use the COLD CP button to mix disinfectant could result in insufficient exposure of one or more tanks to the required quantity of disinfectant.

Failure to change the water can lead to ineffective prevention of bacterial growth.

Add 150 ml of 3% medicalgrade hydrogen peroxide when filling the heater-cooler.

Performing the monthly bacterial monitoring procedure.

Chapter 4.7 Task 2,  3

Chapter 6.6

Failure to add hydrogen peroxide when filling the water tanks can lead to ineffective prevention of bacterial growth.

Task 3,  3 Chapter 6.5.2 Failure to properly sample the water in the

heater-cooler can lead to an inability to identify potentially harmful levels of bacterial growth in the device.

18 CP_IFU_16-XX-XX_USA_021

3 System description

This chapter describes the system’s features and components, and the controls that you will use to control the system’s circuits.

CP_IFU_16-XX-XX_USA_021 19

Heater-Cooler System 3T • System description General description

3.1 General description

3.1.1 Device summary

The Heater-Cooler System 3T is an independent 3-circuit-heating/cooling system which is suitable for continuous use.

The heater-cooler has three circuits that you control from the control display panel:

● Cardioplegia circuit, whose temperature can be controlled from independent

heating and cooling tanks.

● Patient 1 circuit and patient 2 circuit, which can be used with the oxygenator

and/or the single-use heating/cooling blanket. The temperature for these two circuits can be controlled from one heating/cooling tank.

Control panel

Cardioplegia circuit

Patient 1 circuit

C°C°C°

pascals

TANK VACUUM

100

CALIBRATED FOR VERTICAL POSITION

MAX

PRESS

URE

100kPa

C°C°

° C

C°

° C

Patient 2 circuit

20 CP_IFU_16-XX-XX_USA_021

3.1.2 System components

Below are lists of standard components, mandatory components, and optional components that can be used with the heater-cooler. To obtain additional components, contact LivaNova Deutschland GmbH or your local LivaNova distributor.

Standard components (included in delivery)

● Heater-Cooler System 3T

● Aerosol collection container holder

● 1/2" tubing connectors, straight (3 pieces)

● 1/2" tubing connectors, 90° angle (3 pieces)

● CAN cable for connection to the S5/C5 System

● Potential equalization cable

Heater-Cooler System 3T • System description

General description

● Screwdriver for zeroing the vacuum gauge

● Operating instructions

Mandatory components (not included in delivery)

● 3T Aerosol Collection Set

Optional components (not available from LivaNova)

● Tubing sets and/or adapters for connecting single-use heating/cooling

blankets

● Single-use heating/cooling blankets for adults (55 x 150 cm)

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Heater-Cooler System 3T • System description General description

3.1.3 Explanation of the heater-cooler circuits and tanks

The heater-cooler has three circuits: the cardioplegia circuit, the patient 1 circuit, and the patient 2 circuit.

See chapter 3.2.2 for more details on the control panel which you will use to control each circuit.

The cardioplegia circuit uses two tanks

● There is one cardioplegia circuit, accessed from the inlet and outlet valves on

the back of the heater-cooler.

● This circuit can be switched between either the heating tank or the cooling tank

inside the heater-cooler. The heating and cooling tanks are separate so that water can be kept at desired temperatures even when not being accessed:

Cold cardioplegia tank

Temperature range: 2 °C to 10 °C Tank volume: 3 L

Warm cardioplegia tank

Temperature range: 15 °C to 41 °C Tank volume: 3 L

Cardioplegia circuit (inlet and outlet)

● The cardioplegia circuit can only be circulating from one of these tanks at a

time. For example, if the warm cardioplegia pump is running and you power on the cold cardioplegia pump, the heater-cooler will circulate water from the cold cardioplegia tank and stop circulating water from the warm cardioplegia tank.

22 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • System description

General description

The two patient circuits use one tank

● There are two patient circuits, accessed from the patient 1 and patient 2 inlet

and outlet valves on the back of the heater-cooler. These circuits can be used with the oxygenator and/or the single-use heating/cooling blanket.

● The patient 1 and patient 2 circuits can be run at the same time or one at a time.

● Both patient circuits access the same tank (i.e., one tank) inside the heater-

cooler. As such, both patient circuits will always be set to the same temperature.

Patient tank

Temperature range: 2°C to 41°C

Tank volume: 6 L

Patient 2 circuit

(inlet and outlet)

Patient 1 circuit

(inlet and outlet)

● The circuits for the patient and the circuit for cardioplegia can be switched off

separately to increase the heating and cooling performance of active circuit(s). See chapter 5.6 for details.

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Heater-Cooler System 3T • System description General description

How the heater-cooler’s three tanks fill

As you pour water into the single filler neck, all three tanks will fill in the following order:

1. Cold cardioplegia tank

2. Warm cardioplegia tank

3. Patient tank

Additional information about water tank levels:

● The cardioplegia tanks must fill completely before the patient tank begins to fill.

● After filling, and during operation, the system will equalize the water levels

between the two cardioplegia tanks. Therefore, running one pump (i.e., the warm or cold pump) will reduce the water level in both tanks.

24 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • System description

3.2 Structure of the heater-cooler

3.2.1 Heater-cooler overview

Structure of the heater-cooler

1 3

pascals

TANK VACUUM

100

CALIBRAT

ED FOR

VERTICAL POS

ITION

MAX

PRESS

URE 100

kPa

C°C°

° C

C°

° C

1720

7 8 9 10

18 19

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • System description Structure of the heater-cooler

Items depicted in heater-cooler overview

Item Name Function

1 Mains power switch ● For powering the heater-cooler on/off

● Integrated automatic circuit breaker

2 Control panel For separated operation and configuration

of the three circuits

● Two patient circuits

● One cardioplegia circuit

3 Vacuum gauge with scale Indicates the vacuum level inside the tanks 4 Vacuum gauge service port For removing potential obstructions within

the internal pressure monitoring line 5 Filler neck with cap For filling all tanks with filtered tap water 6 CAN jack with cover For connecting the heater-cooler to the S5/

C5 System 7 Patient 2 circuit outlet connector with

valve lever

For connecting the tubing, all inlets and

outlets with 1/2" tubing connectors

8 Patient 2 circuit inlet connector 9 Patient 1 circuit outlet connector with

valve lever 10 Patient 1 circuit inlet connector 11 Cardioplegia circuit inlet connector 12 Cardioplegia circuit outlet connector

with valve lever 13 Patient tank drain valve For emptying the tanks 14 Cardioplegia tank drain valve 15 Overflow outlet For draining excessive water from the tanks

and for connecting the aerosol collection

container 16 Fan For ventilation of the heater-cooler 17 Ventilation grill 18 Potential equalization point For connecting the potential equalization

cable 19 Power cable Power supply of the heater-cooler 20 Castors Castors with brakes 21 Bumper Protects the valves, drains, etc. against

accidental crashes 22 Aerosol collection set (with tubing) For collecting aerosol

26 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • System description

Structure of the heater-cooler

Items depicted in heater-cooler overview (continued)

Item Name Function

23 Connection line (short line) For connecting the aerosol collection

container to the heater-cooler

24 Vacuum port (V) Connection point on the aerosol collection

container for the vacuum source line

25 Vacuum source line (long line) For connecting the aerosol collection

container to the external vacuum source

26 Patient port (P) Connection point on the aerosol collection

container for the connection line 27 Tandem port (T) Unused (capped at all times) 28 Pour spout (S) Port for emptying the aerosol collection

container (capped during normal use)

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • System description Structure of the heater-cooler

3.2.2 Heater-cooler control panel overview

The control panel manages all control and monitoring functions of the heatercooler. Specifically, the control panel:

● Is used to adjust the temperature set values

● Is used to start and stop the circuit pumps

● Displays all set and actual temperatures

● Displays water level in the three tanks

The control panel is divided into two sections:

Cardioplegia circuit controls, which include the warm tank and the cold tank. Patient 1 and patient 2 circuit controls, which includes one tank for the two

patient circuits.

Cardioplegia circuit

Cold

Warm

Patient 1 circuit,

Patient 2 circuit

C°C°C°

28 CP_IFU_16-XX-XX_USA_021

Cardioplegia circuit controls

Cold Warm

1 8 1 8 9

Heater-Cooler System 3T • System description

Structure of the heater-cooler

C°C°C°

54 46 5 6 7 10

C°C°C°

Item Name Function

1 Actual temperature display Display the actual tank temperatures 2 Cold cardioplegia circuit Stop/Stop

button

3 Warm cardioplegia circuit Stop/Stop

button

For starting and stopping the circuit and for

switching from the warm to the cold tank

For starting and stopping the circuit and for

switching from the cold to warm tank

4 Set temperature display Displays the tank set temperatures 5 Set value down button For decreasing the set temperature 6 Set value up button For increasing the set temperature 7 Standby button For switching the cardioplegia circuit on

and off

8 High temperature indicator Illuminates red if high tank temperature

detected

9 Water level display Displays the water level in the tanks

10 Pause audio button (global control) Pauses the audible tone for a maximum of

2 minutes. Pressing the button again

switches the audible tone back on.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • System description Structure of the heater-cooler

Patient 1 and patient 2 circuit controls

1 8 9

C°C°C°

4 5 6 710

C°C°C°

Item Name Function

1 Actual temperature display Display the actual tank temperatures 2 Patient 1 circuit Start/Stop button For starting and stopping the patient 1

circuit

3 Patient 2 circuit Start/Stop button For starting and stopping the patient 2

circuit 4 Set temperature display Displays the set temperatures 5 Set value down button For decreasing the set temperature

6 Set value up button For increasing the set temperature 7 Standby button For switching the patient 1 and patient 2

circuits on and off. 8 High temperature indicator Illuminates red if high tank temperature

detected 9 Water level display Displays the water level in the tanks

10 Pause audio button (global control) Pauses the audible tone for a maximum of

2 minutes. Pressing the button again

switches the audible tone back on.

30 CP_IFU_16-XX-XX_USA_021

Explanation of the water level display

Heater-Cooler System 3T • System description

Structure of the heater-cooler

Water level displays

C°C°C°

Display Segment color Water level meaning

Second green Maximum capacity

First green Full

Orange Solid: Low level

Blinking: Low level warning. Refill recommended.

Red Must be refilled. Pump(s) and heating/

cooling functions stop until refilled. Circuit will not operate.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • System description Structure of the heater-cooler

Explanation of special Set value button operations

● For the cardioplegia Set values, pressing and holding a Set value button

changes the temperature value by 1°C. Continuing to hold the Set value button will increase or decrease the set value more rapidly.

● For the patient set value, pressing and holding a Set value button initially

changes the temperature value by 0.1 °C, then changes the temperature value by 1 °C. If you then release the Set value button and immediately press it once, the temperature value will still change by 1 °C.

C°C°C°

Set value buttons

● You can increase the temperature value change increment by pressing and

holding one Set value button and pressing its counterpart (i.e., up or down) once.

3.2.3 Control panel S5/C5 System

The CAN port allows the heater-cooler to be connected to an S5 or C5 HLM. Operating the heater-cooler with the S5/C5 System does not require additional remote control modules. You do not need to make additional connections or perform additional steps besides connecting the CAN cable between the heatercooler and the S5/C5 System.

You may control the heater-cooler with the S5/C5 System menu or directly on the base unit of the heater-cooler.

NOTE: Do not connect the heater cooler’s CAN port to any other device. The heatercooler is only compatible with the S5/C5 System.

Refer to the S5/C5 System’s operating instructions for information about the heater-cooler’s displays when in use with the S5/C5 System.

Important

The length of water circuit tubing between the heater-cooler and accessory devices must not exceed 5 m.

32 CP_IFU_16-XX-XX_USA_021

4 Preparing the

heater-cooler for a procedure

Read the following chapter thoroughly heater-cooler for the first time.

before operating the

This chapter provides instructions for preparing the heater-cooler for use.

See chapter 5 for detailed instructions for positioning and using the heater-cooler during a procedure.

See chapter 6 for detailed instructions for conducting scheduled maintenance activities.

CP_IFU_16-XX-XX_USA_021 33

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure General technical requirements

4.1 General technical requirements

4.1.1 General use requirements

● Operate the heater-cooler only at ambient temperatures between 10 °C and

30 °C.

● Operate the heater-cooler in a spacious area. The heater-cooler can overheat if

operated in a confined space. Maintain a separation of at least 70 cm between the ventilation grills and walls or other devices.

● Do not position the heater-cooler where it will block access to the mains power

plug. Removing the mains plug from the receptacle isolates the machine from mains voltage and the plug must remain accessible at all times.

● The heater-cooler must be connected to a potential equalization point for the

safety of operators and patients.

● Electrical installations must abide by the requirements stated in

IEC 60364-7-710, or the corresponding equivalent local regulations.

● A central hospital vacuum source or a portable vacuum source must be

available for operating the 3T Aerosol Collection Set.

○ Operate the heater-cooler with an applied vacuum source. Aerosol will not be

collected from the water tanks without a vacuum source.

○ The vacuum source must be capable of a flow of 20 LPM or greater

(ISO 10079-1 for Medical Suction Equipment).

○ Portable vacuum sources must be specified for medical applications and

meet the requirements of IEC 60601-1 and IEC 60601-1-2.

○ The power supply for the vacuum source must be connected to a back-up

power generator to avoid power loss during use.

34 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

General technical requirements

4.1.2 Materials you will need (not provided with the heater-cooler)

● Tubing sets compatible for connecting:

○ the oxygenator ○ the cardioplegia heat exchanger ○ a single-use heating/cooling blanket, if used

● 3T Aerosol Collection Set (part number 050900100)

Important

LivaNova recommends always having a replacement heater-cooler available in case the heater-cooler in use is no longer functional (e.g., due to a total system failure). The replacement heater-cooler must have compatible connectors.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure Conducting any required disinfection and maintenance

4.2 Conducting any required disinfection and maintenance

Before first-time use of the heater-cooler

Complete the following procedures per the maintenance schedule in chapter 6.2.1 “Schedule: Disinfection and maintenance”:

1 Disinfect the external surfaces 1 Disinfect the water circuits

Before each use of the heater-cooler, verify that device maintenance is up to date

Verify that, if necessary, the following maintenance procedures have been completed per the maintenance schedule in chapter 6.2.1 “Schedule: Disinfection and maintenance”:

1 Disinfect the external surfaces 1 Monitor the hydrogen peroxide concentration 1 Replace the aerosol collection set 1 Change the water and add hydrogen peroxide 1 Disinfect the water circuits 1 Monitor the water quality for total bacteria count 1 Monitor the water quality for NTM 1 Replace the tubings used with the heater-cooler

36 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Connecting the procedural tubing

4.3 Connecting the procedural tubing

Important

● Follow your hospital’s policies regarding the use of personal protective

equipment (PPE).

● Before connecting any tubings to the heater-cooler: ○ Disinfect all heater-cooler connectors, tubing fittings, and tubing

connectors.

○ Disinfect all connectors and fittings on the tubings as well as the

connectors for the water circuits.

● Do not use self-closing connectors. They will reduce water flow.

● Check all tubings, connectors, and accessories to ensure all water

connections are properly sealed. Replace damaged components immediately.

● Check that all tubings are free of bends and kinks.

● Close inactive circuits with short-circuit tubing.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure Connecting the procedural tubing

Connect tubing to the water circuits

 1 Before connecting any tubing to

the heater-cooler, disinfect the following items:

○ all heater-cooler connectors ○ all tubing fittings and connectors

Important

Disinfect connectors and fittings every time you make a connection according to chapter 6.3.2 and chapter 6.3.3.

Continue step on next page ▸

38 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Gentle t

Connecting the procedural tubing

 2 Connect the procedural tubing to

the circuit inlet and outlet ports:

○ Push and hold the quick release

ring back.

○ Insert the tubing fitting into the

quick release ring.

○ Release the quick release ring

which will click back into place and lock the tubing.

rcuit inlet and outlet ports

Quick release ring

Insert tubing fitting

Release to lock

 3 Check that the connection is

secure by gently pulling on the tubing fitting.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure Connecting the potential equalization cable and the power supply

4.4 Connecting the potential equalization cable and the power supply

Summary of steps you will complete in this section

1 Connect the potential equalization cable

2 Connect the power cable

Connect the potential equalization cable

 1 Connect the potential equalization

cable to the heater-cooler’s potential equalization point.

 2 Connect the potential equalization

cable’s other end to the potential equalization point at the OR's central ground.

Potential equalization point

40 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Connecting the potential equalization cable and the power supply

Connect the power cable

 1 Connect the AC power cable

to an appropriate outlet.

Power cable

WARNING

Do not connect the heater-cooler to a heart-lung machine’s auxiliary outlet. The heater-cooler should be connected to a separate dedicated AC line.

To avoid the risk of electric shock, the heater-cooler must only be connected to a supply mains with protective earth.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure Connecting the aerosol collection set

4.5 Connecting the aerosol collection set

WARNING

Operation of the heater-cooler without an applied vacuum source will stop the collection of aerosol from the water tanks.

Summary of steps you will complete in this section

1 Dispose of the aerosol collection set after 7 days

2 Prepare the heater-cooler

3 Prepare the aerosol collection canister

4 Connect the aerosol collection set to the heater-cooler

42 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Connecting the aerosol collection set

Dispose of the aerosol collection set after 7 days

If an aerosol collection set is already attached to the heater-cooler (e.g., from a previous procedure), check the installation date written on the aerosol collection canister lid:

● If the aerosol collection set is more

than 7 days old, bring the aerosol collection set to the disposal area, and dispose of in accordance with your hospital’s policies. Be sure to dispose of all components:

○ Canister ○ Canister lid ○ Heater-cooler connection line ○ Vacuum source line ○ Vacuum source extension line (if

applicable)

Installation date

● If the aerosol collection set is less

than 7 days old, you may empty the canister according to chapter 5.7.2 and reconnect the emptied canister following the applicable steps in this chapter. Or, you may replace the entire aerosol collection set.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure Connecting the aerosol collection set

Prepare the heater-cooler

 1 Make sure that the heater-cooler

is powered off.

 2 Verify that the vacuum gauge

reads 0 Pa.

If the vacuum gauge does not read 0 Pa, use the provided screwdriver to turn the adjustment screw near the bottom of the gauge. Turn the adjustment screw until the indicator needle is set to 0 Pa.

Off

C°C°

C°

C°C°

C°

Vacuum = 0 Pa

pascals

TANK VACUUM

CALIBRATED FOR VERTICAL POSITION

M AX PRESSU

RE 1

° C

100

00 kPa

 3 Attach the aerosol collection

canister holder to the heatercooler by inserting the two top tabs of the holder into the vent slots on the heater-cooler. Release the holder and allow it to rest in a horizontal position.

NOTE: Make sure that the holder is positioned such that the aerosol collection canister does not touch the floor or any part of the heatercooler.

44 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Connecting the aerosol collection set

Prepare the aerosol collection canister

 1 Gather a new aerosol collection

set, and remove the components from the packaging:

○ Aerosol collection canister ○ Canister lid ○ Vacuum source line (with right-

angle connector)

○ Heater-cooler connection line

CAUTION

Prior to use, visually inspect the 3T Aerosol Collection Set to ensure that

connections, seals, and components were not damaged during shipment. Do not use the 3T Aerosol Collection Set if any defects are found.

 2 Place the lid on the aerosol

collection canister, and secure the lid around the entire perimeter.

 3 Apply the following caps over their

respective openings:

○ Pour spout ○ Tandem port

 4 Place the aerosol collection

canister into the holder.

our spou

Tandem port

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Right

Connecting the aerosol collection set

Connect the aerosol collection set to the heater-cooler

 1 Connect the heater-cooler

connection line (the short line) to the heater-cooler overflow outlet.

CAUTION

Do not connect the heater-cooler connection line to the vacuum service port or the drain valve. This will limit the vacuum flow to the aerosol collection canister.

 2 Connect the other end of the

heater-cooler connection line (the short line) to aerosol collection canister lid’s PATIENT port (P) .

Heater-cooler overflow outlet

Heater-cooler connection line

PATIENT port (P)

Important

Pushing the connection line too far onto port will make the line very difficult to remove later.

 3 Connect the vacuum source line’s

(the long line) right angle connector to the aerosol collection canister lid’s VACUUM port (V).

 4 Check that the vacuum source line

acuum source line

is free of kinks.

ACUUM port

(V)

Continue step on next page ▸

angle connecto

46 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Connecting the aerosol collection set

 5 Connect the vacuum source line’s

(the long line) other end to the external vacuum source.

NOTE: LivaNova recommends connecting an overflow safety trap to the external vacuum source. This will avoid liquid introduction into the external vacuum source’s system.

NOTE: If additional length is needed to access the external vacuum source, attach a vacuum extension line to the vacuum source line. Order this part separately (part number

050900111).

CAUTION

External vacuum source

Vacuum source line

You must connect the vacuum source line to a vacuum regulator. This will control and adjust the flow to the aerosol collection canister.

Continue step on next page ▸

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

lid

Connecting the aerosol collection set

 6 Check that all lid caps and

connections are secure:

1 Vacuum source line (a) 1 Heater-cooler connection line (b) 1 Tandem port cap (c) 1 Pour spout cap (d) 1 Vacuum source extension line (if

applicable)

 7 Write the date of installation on

the lid’s label.

 8 The aerosol collection set is now

ready for use.

op view of

48 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Connecting to the S5/C5 System (if applicable)

4.6 Connecting to the S5/C5 System (if applicable)

Connect the heater-cooler to the S5/C5 System

Connect the heater-cooler to the S5/C5 System according to the separate S5/C5 System’s operating instructions.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure Filling and mixing water tanks

4.7 Filling and mixing water tanks

Important

● Follow your hospital’s policies regarding the use of personal protective

equipment (PPE).

● Do not use de-ionized or reverse osmosis processed water. These types of

water can cause deterioration of the refrigeration system.

Summary of steps you will complete in this section

1 Prepare for filling

2 Fill the water tanks

3 Prepare for mixing

4 Mix the tank contents

50 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Filling and mixing water tanks

Prepare for filling

 1 Make sure that you have access to filtered tap water that has been filtered

using the following filter and specifications:

Important

(*American Standard Test Method F838-15ae1 “Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration”)

 2 Gather the following materials:

○ 150 mL of medical grade 3% hydrogen peroxide solution ○ Measuring cup

 3 Check to ensure that hydrogen peroxide solution is not expired.

CFU/cm2 of effective filtration area.*

 4 If the water tanks have been

drained (i.e., are empty), the red segment on both water level displays will be illuminated.

NOTE: Confirm that the water level displays function correctly after performing a water change or disinfection.

 5 Make sure that the aerosol

collection canister is empty. Refer to chapter 5.7.2 for instructions on emptying the aerosol collection canister.

Empty

C°

Continue step on next page ▸

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

TANK VACUUM

CALIBRATED FOR

VERTICAL POSITION

M AX P

RES

SURE

100

k Pa

pascals

100

Filling and mixing water tanks

 6 Make sure that both drain valves

are fully closed so that water does not flow out when filling the water tanks.

 7 Press the mains power switch to

power on the heater-cooler.

NOTE: A tone will sound indicating that the heater-cooler tanks are empty. You can press the Pause Audio button to pause the tone.

Pause audio

C°C°

° C

C°C°

 8 Turn the filler neck cap

counterclockwise to remove.

 9 Apply four sprays of disinfectant

on the cap until all surfaces are wet, including the cap’s underside and sealing surface.

 10Wait for 5 minutes. Ensure that all

surfaces remain wet with disinfectant during this time. Apply additional disinfectant if necessary.

Wipe all surfaces with a disinfectant wipe for 2 minutes to remove excess disinfectant.

Wait for 5 minutes, then wipe off excess for 2 minutes

52 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

filt

TANK VACUUM

CALIBRAT

ED FOR

VERTICAL POSITION

MAX

PRES

SUR E

0kPa

pasc

als

100 100

Filling and mixing water tanks

Fill the water tanks

Important

As you pour water into the single filler neck, all three tanks will fill in the following order:

● Cold cardioplegia tank

● Warm cardioplegia tank

● Patient tank

If the water tanks are not empty:

● Prepare a mixture of hydrogen

peroxide and filtered tap water at a ratio of 1:91. For example: 10 mL of hydrogen peroxide and 910 mL of filtered tap water

● Fill the water tanks with the mixture

until the second green segments of both circuit water level displays light up.

1:91 mixture hydrogen peroxide to tap water

C°

36.8

ered

pasc

TANK VACUUM

100

C ALIBRA

D F V E

I C AL

OSITION

M AX

P RE

SS UR

0k P a

36.8

C°C°C°

C°C

● Continue to step 3, Prepare for

mixing.

If the water tanks

are empty, complete

the rest of step 2:

 1 Begin filling the water tanks with

filtered tap water.

NOTE: The use of any other liquid is not recommended.

Continue step on next page ▸

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

150 mL hyd

TANK VACUUM

CALIBRAT

ED FOR

ERTICAL POSITION

A X PRESS

URE

00kP

pascals

100

Filling and mixing water tanks

 2 Pause filling when the orange

segment on the patient circuit

water level display lights up.

 3 Pour 150 mL of medical grade 3%

hydrogen peroxide solution into the tank.

 4 Continue filling the tanks with

filtered tap water until the second

green segment of the patient

circuit water level display lights

up.

C°

rogen peroxide

C°

36.8

C°C

C°

C°C°C°

Patient circuit

pas

al s

TANK

100

VACUUM

C ALIBRA

TE D

I C AL

P O SITION

M AX

P RE

UR E 10

P a

Patient circuit

 5 Attach the filler neck cap, and turn

clockwise to secure.

54 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Patient 1C

Filling and mixing water tanks

Prepare for mixing

 1 On the back of the heater-cooler,

make sure that the three red valve levers are closed. Turn clockwise to close.

 2 Disinfect the heater-cooler

connectors and short-circuit tubing fittings.

Important

Disinfect connectors and fittings every time you make a connection according to chapter 6.3.2 and chapter 6.3.3.

 3 Connect short-circuit tubing

between the cardioplegia circuit inlet and the patient 1 circuit inlet.

ose all valves

ardioplegia

 4 To avoid triggering a high temperature warning while mixing:

Set the cold cardioplegia circuit to 10 °C.

CP_IFU_16-XX-XX_USA_021

Set the warm cardioplegia circuit to 20 °C.

Set the patient circuit to

20.0 °C.

C°C°C°

Heater-Cooler System 3T • Preparing the heater-cooler for a procedure

Filling and mixing water tanks

Mix the tank contents

 1 Press the cold cardioplegia circuit

Start/Stop button to start mixing.

NOTE: The green LEDs will flash alternately to indicate the circuit is running.

CAUTION

Operate ONLY the cold cardioplegia circuit to ensure proper mixing.

 2 After 5 minutes, press the cold

cardioplegia circuit Start/Stop

button again to stop mixing.

ress cold cardioplegia to star

ter 5 minutes, press to stop

C°C°

The mixing process is now complete.

C°C°

 3 Disconnect the short-circuit

tubing.

Tank filling is now complete.

56 CP_IFU_16-XX-XX_USA_021

5 Using the

heater-cooler during a procedure

Read the following chapter thoroughly heater-cooler for the first time.

before operating the

This chapter provides instructions for positioning the heater-cooler in the OR and using the heater-cooler’s controls during a procedure.

See chapter 4 for detailed instructions for preparing the heatercooler for use.

This chapter also provides the basic steps you will conduct after a procedure.

See chapter 6 for detailed instructions for conducting scheduled maintenance activities.

CP_IFU_16-XX-XX_USA_021 57

Heater-Cooler System 3T • Using the heater-cooler during a procedure Positioning the heater-cooler in the OR

5.1 Positioning the heater-cooler in the OR

Important

● Do not cover the ventilation grills.

● Maintain at least 70 cm clearance from walls and other devices to prevent the

heater-cooler from overheating.

● The length of water circuit tubing between the heater-cooler and accessory

devices must not exceed 5 m.

Summary of steps you will complete in this section

1 Bring the heater-cooler into the OR

2 Place the heater-cooler in a safe position

3 Connect a portable vacuum source, if needed

Bring the heater-cooler into the OR

 1 If the heater-cooler is not already

in the OR, bring the heater-cooler to the OR.

 2 Place the heater-cooler on a level,

even floor.

Even floor

58 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Positioning the heater-cooler in the OR

Place the heater-cooler in a safe position

pascals

 1 Place the heater-cooler at a

sufficient distance (at least 70 cm) from walls and other devices.

C°C°

Make sure that the ventilation grills are not covered.

 2 Position the heater-cooler’s and portable vacuum source’s (if applicable)

exhaust flow away from the operating field and toward the exhaust vent system.

Exhaust (on back)

TANK VACUUM

100

CAL IBR

ATED FOR

VERTIC

AL POSIT

I ON

M A X PR

ESS URE 100kPa

°C°C° C

° C

Ventilation grills

WARNING

Do not position the heater-cooler’s and portable vacuum source’s (if applicable)

exhaust flow toward the operating field. Position the exhaust flow away from the operating field and toward the exhaust vent system.

Continue step on next page ▸

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Positioning the heater-cooler in the OR

 3 Step down on the brakes and lock the castors.

Lock brakes

pasca

TANK VACUUM

100

CAL

I BR

ATED FOR

VERTIC

A L POSIT

I O N

M AX PR

ESSU R

E 100 kP a

C°C°

° C

C°

° C

Connect a portable vacuum source, if needed

 If you are using a portable vacuum source, mount and operate the device

according to its instructions for use. Pay special attention to the instructions related to use of the vacuum source in the OR.

60 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Connecting the procedural tubing to external devices

5.2 Connecting the procedural tubing to external devices

Summary of steps you will complete in this section

1 Connect the procedural tubing to the external devices

2 Check the procedural tubing and connections to all devices

Connect the procedural tubing to the external devices

 1 Before making any connections,

disinfect the connectors on the procedural tubing.

Important

● Disinfect the connectors and fittings every time you make a connection

according to chapter 6.3.2 and chapter 6.3.3.

● Do not apply disinfectant to the fittings on the external devices.

 2 Connect the procedural tubing to the external devices.

CP_IFU_16-XX-XX_USA_021

Check the procedural tubing and connections to all devices

 Inspect the heater-cooler procedural tubing and make sure:

● Tubing is free of kinks

● Tubing is not damaged

● Connections to devices in the OR are secure

Heater-Cooler System 3T • Using the heater-cooler during a procedure Connecting the procedural tubing to external devices

Overview of a typical circuit

Cardioplegic solution

Heating/cooling blankets (single-use)

Oxygenator

Oxygenator heat exchanger

Patient

Cardioplegia heat exchanger

Connection patient circuit 1

Connection patient circuit 2

Rear view Heater-Cooler System 3T

Connection cardioplegia circuit

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Heater-Cooler System 3T • Using the heater-cooler during a procedure

Powering on and checking the panel

5.3 Powering on and checking the panel

WARNING

Operation of the heater-cooler without an applied vacuum source will stop the collection of aerosol from the water tanks.

Summary of steps you will complete in this section

1 Connect the vacuum source

2 Power on the heater-cooler and observe the self-test

3 Check the control panel to confirm the heater-cooler is ready for

use

Connect the vacuum source

 1 Verify that the vacuum gauge

reads 0 Pa.

If the vacuum gauge does not read 0 Pa, use the provided screwdriver to turn the adjustment screw near the bottom of the gauge. Turn the adjustment screw until the indicator needle is set to 0 Pa.

Continue step on next page ▸

C°C°

C°

Vacuum = 0 Pa

° C

pascals

TANK VACUUM

100

CALIBRATED FOR

VERTICAL POSITION

M AX PR

ESSU

RE 100

kPa

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Powering on and checking the panel

 2 Check the installation date on the

aerosol collection canister.

If more than 7 days have passed since the installation date, dispose of the aerosol collection canister and install a new one according to chapter 4.5.

 3 Power on the external vacuum

source and set the vacuum regulator to full open flow.

o more than 7 days o

Full open flow

 4 Make sure that the heater-cooler’s

vacuum gauge reads greater than 50 Pa.

NOTE: With full open vacuum flow, the heater-cooler’s vacuum gauge might read greater than 100 Pa. The vacuum gauge can accept full vacuum flow.

Vacuum > 50 Pa

C°C°

° C

C°C°

° C

pascals

TANK VACUUM

100

CALIBRATED FOR VERTIC

AL POSITION

M AX PR

ESSURE 100

kPa

64 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Powering on and checking the panel

Power on the heater-cooler and observe the self-test

 1 Press the mains power switch to

power on the heater-cooler.

C°C°

C°

 2 The heater-cooler will run a self-test while powering up. All of the control

panel’s LEDs and 7-segment displays will illuminate for 2 seconds, and a tone will sound.

Check that all LEDs and 7-segment displays are properly illuminated before use.

C°

° C

 3 After the control panel lights up,

the device’s software version number (EPROM) will display for 1 second in the patient circuit display.

 4 The heater-cooler is now finished

powering on and will display the last set temperature values. The heater-cooler is now actively controlling the tank temperatures, but the circuit pumps are not running.

C°C°C°

C°

Version number appears in patient circuit display

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Powering on and checking the panel

Check the control panel to confirm the heater-cooler is ready for use

Important

Do not use the heater-cooler if the elements on the control panel are flashing. If the control panel is flashing, the heater-cooler is in service mode. Power off the heater-cooler and power it on again to exit service mode.

 1 Once the self-test is complete, confirm the following:

○ The green LEDs of the Standby buttons are not illuminated (i.e., the circuits

are not in standby mode).

○ The control panel displays the last set temperature values. ○ Both circuit water level displays are illuminated to the second green

segment.

 2 The heater-cooler is ready for use.

C°C°C°

66 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

If errors EE(E) appear on control panel

If a circuit’s set point display flashes between “EE(E)” and a number, this is an error code:

● Error code E08, E19, or E23 might

display during priming, but should clear when priming completes (all air is removed from the circuit).

● Do not use a circuit if an error code

remains after priming. Refer to chapter 8.1.4 for error code definitions, and notify your authorized service technician as soon as possible.

NOTE: You may use the unaffected circuits even if one circuit displays an error code.

Powering on and checking the panel

Flashes between error and code number

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Performing a functional check prior to operation

5.4 Performing a functional check prior to operation

Important

● Perform the steps outlined in this chapter before every time you use the

heater-cooler.

● Address any error codes immediately. Depending on the error code, you

might not be able to use a particular circuit, or you might not be able to use the heater-cooler at all. Refer to chapter 8.1.4 for error code descriptions.

● The heater-cooler is ready for operation after you have performed the

functional check.

Summary of steps you will complete in this section

1 Check the setup

2 Check when first switching power on

68 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Performing a functional check prior to operation

Check the setup

1 Confirm the heater-cooler’s and portable vacuum source’s (if applicable)

exhaust is pointed away from the operating field.

WARNING

Do not position the heater-cooler’s and portable vacuum source’s (if applicable)

exhaust flow directed toward the operating field. Position the exhaust flow away from the operating field and toward the exhaust vent system.

1 Confirm that the heater-cooler is positioned on a level, even floor. 1 Confirm that the castor brakes are locked. 1 Confirm that the power cable and potential equalization cable have been

connected according to applicable regulations.

1 Confirm that the mains plug is completely dry. 1 Confirm that the power cable is free of damage. 1 Confirm that all tubing connectors are secure and locked. 1 Confirm that all procedural tubings are free of damage and leaks. 1 Confirm that the aerosol collection set is less than 7 days old. 1 Confirm that the aerosol collection canister is holding less than 0.5 L of fluid. 1 Confirm that the heater-cooler’s vacuum gauge reads greater than 50 Pa with

full open vacuum flow applied.

1 Confirm that a replacement heater-cooler with compatible connectors is

available.

1 Confirm that the CAN cable is properly connected (if you are operating the

heater-cooler with a S5/C5 System).

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Performing a functional check prior to operation

Check when first switching power on

1 Confirm that all LEDs and temperature displays on the control panel are

illuminated.

1 Confirm that a tone sounded. 1 Confirm that the control panel is reflective of a functioning heater-cooler (i.e.,

the heater-cooler is not in service mode and does not display errors). If the heater-cooler displays an error, refer to chapter 8.1.4 for error code descriptions.

1 Confirm that the water level indicators on the patient and cardioplegia circuit

displays are not blinking orange or solid red.

70 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Up butt

5.5 Priming the complete circuit

Summary of steps you will complete in this section

1 Adjust the set values as needed

2 Place unused circuits in standby mode

3 Prime the external circuits

Priming the complete circuit

Adjust the set values as needed

Important

The heater-cooler will begin adjusting temperatures to the set values 2 seconds after the last Set value button press.

 To adjust the set values:

○ Press the Set value up button to

raise the circuit temperature.

C° C° C°

○ Press the Set value down button to

lower the circuit temperature.

Down buttons

ons

CP_IFU_16-XX-XX_USA_021

Place unused circuits in standby mode

 If not being used, press the

circuit’s Standby button to place the circuit on standby.

NOTE: The other circuit will continue to function and the heating/cooling performance will be increased.

Standby buttons

Heater-Cooler System 3T • Using the heater-cooler during a procedure

O U

Priming the complete circuit

Prime the external circuits

Important

Prime the circuits’ tubings and heat exchanger before using the heater-cooler.

● When you power on a circuit for the first time, an error code might appear

indicating that air is present in the tubings.

● Do not use the heater-cooler until you have resolved the errors by completely

priming the external circuits.

 1 On the back of the heater-cooler,

for any circuits with tubing connected, turn the red levers counterclockwise to open the valves.

pen valves connected to tubing

 2 Prime the cardioplegia circuit

using the cold cardioplegia tank.

NOTE: Do not use the warm cardioplegia tank to prime. This will trigger an error code and stop the circuit pump.

Continue step on next page ▸

se cold cardioplegia circuit to prime

C°C°

72 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Pri

Priming the complete circuit

 3 Prime the patient circuit(s) using

the associated pump(s).

NOTE: Do not run a pump if there is no tubing connected.

 4 Depending on the volume of the

circuit tubing, you might need to refill the water tanks after priming. Check the water level displays:

○ Make sure the first or second

green segments on both water level displays are illuminated.

○ If not, refill the water tanks before

use according to chapter 4.7, step 1 and step 2.

me patient 1 and patient 2 circuits

C°

cceptable volume

Cardioplegia or patient circuits

Unacceptable volume

Cardioplegia or patient circuits

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Using the device controls during a procedure

5.6 Using the device controls during a procedure

5.6.1 Checking the vacuum

Checking the vacuum

Adjust the external vacuum source to full open vacuum flow to check that the

Vacuum > 50 Pa

heater-cooler operates at vacuum levels

pascals

greater than 50 Pa.

C°C°

° C

C°C°

° C

TANK VACUUM

100

CALIBRATED FOR VERTIC

AL POSITION

M AX PRESSU

RE 1

00 kPa

WARNING

Operating the heater-cooler with the vacuum level indicated on the tank vacuum gauge in the red solid zone limits the aerosol collection set’s ability to collect aerosol from the water tanks. Refer to chapter 8.2.1 for possible remedies.

74 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Using the device controls during a procedure

5.6.2 Opening and closing the circuit valves

Important

● To fill the tubing and to run water through the circuits, the valves must be

open.

● To drain tubing, the valves must be closed.

Opening a valve

On the back of the heater-cooler, for any circuits with tubing connected, turn the red levers counterclockwise to open the valves.

Closing a valve

On the back of the heater-cooler, turn the red valve lever clockwise to close the valve.

pen valves connected to tubing

ose valves

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Up b

Using the device controls during a procedure

5.6.3 Using the circuit controls

Adjusting the set values

Important

The heater-cooler will begin adjusting temperatures to the set values 2 seconds after the last Set value button press.

To adjust the set values:

● Press the Set value up button to raise

the circuit temperature.

● Press the Set value down button to

C° C° C°

uttons

lower the circuit temperature.

Down buttons

Special Set value button operations:

Cardioplegia: Pressing and holding a Set value button changes the temperature value by 1 °C. Continuing to hold the Set value button will increase or decrease the set value more rapidly.

Patient: Pressing and holding a Set value button initially changes the temperature value by 0.1 °C, then changes the temperature value by 1 °C. If you then release the Set value button and immediately press it once, the temperature value will still change by 1 °C.

You can increase the temperature value change increment by pressing and holding one Set value button and pressing its counterpart (i.e., up or down) once.

76 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Operating the cardioplegia circuit

Using the device controls during a procedure

How the cardioplegia circuit works: The cardioplegia circuit has two tanks: a

warm tank and a cold tank. The warm and cold cardioplegia tanks operate using a single circuit. Only one cardioplegia circuit (warm or cold) can run at a time.

You can control each tank’s temperature independently so that warm and cold water sources are available on demand during a procedure.

The temperature range for the cold

cardioplegia tank is: 2 °C to 10 °C.

The temperature range for the warm

cardioplegia tank is: 15 °C to 41 °C.

Starting the cardioplegia circuit:

Press the Start/Stop button of your desired cardioplegia circuit to run the circuit.

One circuit

Cold cardioplegia Warm

cardioplegia

C°C°

Cold cardioplegia Warm

cardioplegia

The water from the selected cardioplegia circuit’s tank (warm or cold) will fill the cardioplegia circuit.

NOTE: The green LEDs will flash alternately to indicate the circuit is running.

LEDs flash

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

ill

Using the device controls during a procedure

Switching between cardioplegia tanks (warm or cold):

Press the Start/Stop button of the inactive cardioplegia tank to run the circuit.

Within 5 seconds, the active cardioplegia circuit will stop running, and the water from the selected cardioplegia circuit’s tank (warm or cold) will fill the cardioplegia circuit.

NOTE: The green LEDs will flash alternately to indicate the circuit is running.

Stopping the cardioplegia circuit: Press the Start/Stop button of the active

cardioplegia circuit to stop the circuit. The cardioplegia circuit will stop

running. NOTE: The green LEDs will go out when

the cardioplegia circuit stops running.

tart one cardioplegia circuit and the other w

stop

C°C°

Cold cardioplegia Warm

cardioplegia

OFF

LEDs off

OFF

LEDs off

Important

Put the cardioplegia circuit in standby when it is not in use. Leaving the cardioplegia circuit active

Cardioplegia Standby button

reduces the patient circuits’ heating/cooling performance.

78 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Pati

Operating the patient circuits

Using the device controls during a procedure

How the patient circuits work: The patient 1 and patient 2 circuits

operate using separate circuit valves and pumps. Both patient circuits can run at the same time.

The patient 1 and patient 2 circuits use the same water tank. The temperature of both patient circuits will always be the same.

The temperature range for the patient tank is 2 °C to 41 °C.

Starting the patient circuit(s): Press the Start/Stop button of your

desired patient circuit to run the circuit. NOTE: The green LEDs on the patient(s)

circuit(s) will flash alternately to indicate the circuit is running.

ent 1

Patient 1 Patient 2

LEDs flash

ent

C°

LEDs flash

Stopping the patient circuit(s):

Press the Start/Stop button of the active patient circuit(s) to stop the circuit(s).

NOTE: The green LEDs will go out when the patient(s) circuit(s) stops running.

Important

Put the patient circuits in standby when they are not in use. Leaving the patient circuits active reduces the cardioplegia circuits’ heating/cooling performance.

Patient 1 Patient 2

OFF

LEDs off

Patient Standby button

OFF

LEDs off

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Completing a procedure

5.7 Completing a procedure

WARNING

Do not empty the external circuits until the patient has been discharged from

the OR environment to reduce the potential of exposure to aerosol.

5.7.1 Drain and disconnect tubing

Summary of steps you will complete in this section

1 Confirm the patient is not in the room

2 Prepare the heater-cooler for draining

3 Drain the external circuits

4 Disconnect the tubing from the external devices

5 Power off the heater-cooler

80 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Completing a procedure

Confirm the patient is not in the room

 Confirm that the patient has been discharged from the OR before

conducting any further steps.

Patient must NOT be in

the room

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Completing a procedure

Prepare the heater-cooler for draining

 1 Make sure that the heater-cooler

is powered on when draining. If needed, press the mains power switch to power on the heatercooler.

 2 Make sure that the aerosol

collection set is connected and the vacuum source is connected and set to maximum.

Vacuum source

connected

C°C°

° C

C°

WARNING

Do not shut off the applied vacuum source until you have drained the circuits

and powered off the heater-cooler. Operate the heater-cooler with an applied vacuum source to ensure that aerosol continues to be collected from the water tanks.

Important

If you are draining longer tubes with high volumes, there is a potential for overflowing the aerosol container. If the volume in the container exceeds 0.5 L, pause the draining of the circuit and empty the aerosol container according to chapter 5.7.2, then continue draining.

Continue step on next page ▸

82 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

t/St

 3 To prevent excess overflow, drain

water from the patient circuit tank until the orange segment on the patient circuit water level display flashes.

Close the drain valve after draining this amount from the tank.

Drain patient circuit until orange segment displays

C°

Completing a procedure

Drain the external circuits

WARNING

Do not close all valves at once when draining water circuits. Always close one circuit valve at a time. Failure to close the external water circuit valves in the order specified below may result in increased levels of aerosol emission.

 1 Make sure that the circuit pumps

are running on any circuits that are connected. Press the Start/Stop buttons if needed.

NOTE: The green LEDs will flash alternately to indicate the circuit is running.

Continue step on next page ▸

xample of Star

Warm

cardioplegia

LEDs flash

op buttons:

Patient 1

LEDs flash

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

t/St

Completing a procedure

 2 With either cardioplegia pump

running, turn the cardioplegia circuit’s red valve lever clockwise to close the valve.

Allow the external water circuit volume to enter the tank before closing the next valve.

 3 Turn the patient 1 circuit’s red

valve lever clockwise to close the valve.

Allow the external water circuit volume to enter the tank before closing the next valve.

ose cardioplegia valve, wait to drain

ose patient 1 valve, wait to drain

 4 If in use, turn the patient 2

circuit’s red valve lever clockwise to close the valve.

The water from the external circuit will return to the patient circuit tank.

 5 Press the Start/Stop button of the

active circuit(s) to stop the circuit(s).

NOTE: The green LEDs will go out when the circuit(s) stops running.

ose patient 2 valve, wait to drain

xample of Star

Warm

cardioplegia

OFF

LEDs off

op buttons:

Patient 1

OFF

LEDs off

84 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Completing a procedure

Disconnect the tubing from the external devices

 1 Make sure that the circuits are

drained before disconnecting any tubing.

 2 Disconnect all procedural tubing

from external devices.

 3 Disconnect the procedural tubing

from the heater-cooler OR Disinfect the tubing connectors and suitable short-circuit connectors (part number 73-300-160). Then, short-circuit the procedural tubing.

Important

Disinfect the connectors and fittings every time you make a connection according to chapter 6.3.2 and chapter 6.3.3.

Connect tubing

Power off the heater-cooler

 Press the mains power switch to

power off the heater-cooler. The vacuum source may now be shut off and/or disconnected.

Off

C°C°

° C

C°

° C

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Completing a procedure

5.7.2 Emptying and/or disposing of the aerosol collection set

Summary of steps you will complete in this section

1 Empty the aerosol collection canister

2 Dispose of and replace, or reconnect the aerosol collection set

based on the date it was installed

Empty the aerosol collection canister

WARNING

The aerosol collection canister contents are potentially hazardous due to collection of bacteria. Use appropriate Personal Protection Equipment (PPE), and handle the contents accordingly.

CAUTION

Do not expose the aerosol collection canister’s hydrophobic lid filter to the water inside the aerosol collection canister. This will seal the filter, which will stop vacuum flow and limit the aerosol collection canister’s ability to collect aerosol from the heater-cooler’s water tanks.

If the hydrophobic lid filter has been exposed to water, replace the aerosol collection set according to the steps in this chapter.

 1 Make sure that the heater-cooler

is powered OFF. If needed, press the mains power switch to power

Off

off the heater-cooler.

C°C°

° C

C°

Continue step on next page ▸

86 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

DO NOT lift by lid

Completing a procedure

CAUTION

Do not disconnect the vacuum source if the heater-cooler is powered on.

 2 Disconnect the vacuum source

line (the long line) from the

vacuum regulator.

Disconnect vacuum

 3 Disconnect the heater-cooler

connection line and vacuum source line from the canister lid.

 4 If you are disposing of the aerosol

collection set (instead of only emptying), also disconnect the heater-cooler connection line from the back of the heater-cooler.

 5 Lifting from the canister body,

carefully remove the aerosol collection canister from the holder.

NOTE: Do not lift the aerosol collection canister by the lid, as the weight of the contents might cause the lid to separate from the aerosol collection canister.

eater-cooler connection

acuum source line

Lift canister body

Continue step on next page ▸

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Completing a procedure

 6 Uncap the pour spout on the

Uncap pour spot

aerosol collection canister.

CAUTION

Do not expose hydrophobic filter in Canister Lid to water when emptying the

canister. Exposure to water will block filter and cause it to not function.

 7 Empty the aerosol collection

canister in accordance with your hospital’s policies.

NOTE: Empty the aerosol collection canister outside of the OR, if possible.

 8 Recap the pour spout on the

aerosol collection canister.

DD/MM/YYYY

Recap pour spot

Empty

88 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure

Completing a procedure

Dispose of and replace, or reconnect the aerosol collection set based on the date it was installed

 1 Check the installation date written

on the aerosol collection canister lid:

○ If the aerosol collection set is less

than 7 days old, you may reconnect the emptied canister using the same heater-cooler connection line and vacuum source line. Or, you may replace the entire aerosol collection set.

○ If the aerosol collection set is

more than 7 days old, replace the entire aerosol collection set including all its components and lines.

 2 Follow the applicable steps in

chapter 4.5 to connect a new or emptied aerosol collection set to the heater-cooler.

Installation date

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Using the heater-cooler during a procedure Completing a procedure

5.7.3 Conducting any required maintenance according to schedule

Clean and disinfect the heater-cooler surfaces after every use

 Clean and disinfect the heater-

cooler surfaces after every use according to the instructions in chapter 6.3.

C°C°

C°

pascals

TANK VACUUM

100

CALI BRATED FOR VER TIC

AL P

O SI

TIO N

M AX PRE

SSU

RE 1 00

k Pa

° C

Review the schedule for disinfection and maintenance

 Review the schedule for disinfection and maintenance in chapter 6.2.1 to

determine if any additional maintenance, cleaning, and/or disinfection tasks are required.

90 CP_IFU_16-XX-XX_USA_021

6 Maintaining the

heater-cooler

Regular maintenance is an important factor for the operation of the heater-cooler as it results in operational safety, reliability and increased service life.

CP_IFU_16-XX-XX_USA_021 91

Heater-Cooler System 3T • Maintaining the heater-cooler General maintenance precautions

6.1 General maintenance precautions

6.1.1 Safety instructions for routine maintenance

WARNING

It is important to follow the cleaning and disinfection process described in these operating instructions to help reduce the risk of contamination.

Personnel and preparation:

● Only individuals trained to use the heater-cooler should perform

maintenance on the heater-cooler.

● Only service technicians authorized by LivaNova may repair the heater-cooler

system.

● Only refrigerant systems experts are authorized to repair the cooling circuit.

● Do not service the internal components of the heater-cooler. Only LivaNova

representatives — or other service personnel deemed qualified by LivaNova — are authorized to maintain, service, and repair internal components of the heater-cooler.

Materials and protective equipment:

● When performing any maintenance activities on the heater-cooler, follow

your hospital’s personal protection equipment (PPE) policy to protect against exposure to hazardous materials, such as bacteria and/or disinfectant chemicals.

92 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Maintaining the heater-cooler

General maintenance precautions

CAUTION

Materials and protective equipment:

● Use only cleaning agents and disinfectants that are approved for use in the

concentrations specified in chapter 6.3 and 6.4.1. Deviating from the labeling could cause damage to the heater-cooler.

Timing:

● Conduct regular maintenance of the heater-cooler. Doing so will result in

operational safety, reliability, and increased service life.

● Perform all cleaning and disinfecting procedures according to the

maintenance schedule provided in chapter 6.2.

● Disinfect the heater-cooler before using it for the first time. Disinfect the

heater-cooler before storage.

NOTICE

● Adhere to local regulations related to documenting all maintenance

procedures, as required by European Directive 93/42, and any operating failures in a medical device log. The medical device log should be presented to authorized service personnel upon request.

NOTE: LivaNova recommends documenting this information regardless of local regulations. Providing this information to LivaNova will assist with maintenance and support activities.

● Exposing the heater-cooler to disinfectant for longer than its intended

exposure time will increase the wear on the device and might lead to premature failure of the heater-cooler.

● All ventilation grills must be cleaned at regular intervals to avoid

contamination. Detailed information on this subject is provided in chapter 6.8.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Maintaining the heater-cooler Maintenance schedule and checklists

6.2 Maintenance schedule and checklists

This chapter includes a schedule of maintenance tasks and several checklists you should use to make sure that the heater-cooler is properly maintained, disinfected, and functioning.

6.2.1 Schedule: Disinfection and maintenance

Timing Task Chapter

Before first-time use, before storing

Upon every connection Disinfect connections and fittings 6.3.3 After every use Clean and disinfect external surfaces 6.3.1 Daily, before use

Daily, when in storage Every 7 days Replace the aerosol collection set 5.7.2 Every 7 days Change the water and add hydrogen peroxide 6.6 Every 14 days (including

when in storage) Once a month ● Monitor the water quality for total bacteria count

Once a year Replace the tubings used with the heater-cooler 6.9

Clean and disinfect external surfaces, connectors, and fittings

Disinfect the water circuits 6.4

Monitor the hydrogen peroxide concentration 6.5.1

Disinfect the water circuits 6.4

● Monitor the water quality for NTM

NOTE: Conduct before and after disinfecting the water circuits

6.3

6.5.2

Once a year or 1,000 hours (which ever comes first)

94 CP_IFU_16-XX-XX_USA_021

Schedule a maintenance check after every 1,000 operating hours or at least once every 12 months, whichever comes first.

6.2.4

Heater-Cooler System 3T • Maintaining the heater-cooler

Maintenance schedule and checklists

6.2.2 Checklist: Daily or with every use

Perform these checks daily or every time you use the heater-cooler

1 Check the maintenance schedule in 6.2.1 to determine whether any

maintenance activities are due. Perform the required maintenance activities according to their corresponding instructions.

1 Make sure that the daily monitoring of the hydrogen peroxide concentration has

been completed per 6.5.1.

1 Dispose of used single-use items according to local environmental regulations

and the manufacturer’s instructions.

1 Check the installation date on the aerosol collection canister.

○ If more than 7 days have passed, replace the aerosol collection canister.

Refer to chapter 5.7.2 for instructions on replacing the aerosol collection set.

○ If 7 days or fewer have passed, check the fill level on the aerosol collection

set and empty it if needed, according to instructions in chapter 5.7.2.

1 Contact LivaNova if the heater-cooler or any of its components are defective or

damaged.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Maintaining the heater-cooler Maintenance schedule and checklists

6.2.3 Checklist: Mechanical checks

● Perform regular checks to ensure that the heater-cooler is in proper working

condition, and to reduce or eliminate the chance of malfunction.

● Do not use the heater-cooler if the heater-cooler does not meet all the

conditions listed in this chapter.

● Contact LivaNova if the heater-cooler or any of its components are damaged or

require service.

Check the heater-cooler’s main power, potential equalization, and CAN cable

 Make sure:

1 The cables are free of damage (e.g., cracks, cuts, kinks) along the entire length

of the cable

1 All contacts are clean 1 The plugs are free of mechanical damage (e.g., no damage to housing and no

bent pins)

1 The mains power connection to the heater-cooler is secure with no movement

between cable and strain relief

Check the water circuits

 Make sure:

1 Water tubing is free of damage and leaks 1 Water circuit connections are free of damage and leaks 1 Water circuit connectors lock and unlock smoothly

96 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Maintaining the heater-cooler

Maintenance schedule and checklists

6.2.4 Checklist: Regular maintenance from LivaNova

You/your organization is responsible for scheduling maintenance checks from a

LivaNova service technician. Only LivaNova representatives — or other service personnel deemed qualified by

LivaNova — are authorized to perform maintenance checks of the heater-cooler. Maintenance checks by LivaNova service technicians include, but are not limited

to, the following:

● Status checks

● Electrical safety checks

● Operational safety checks

● Status of the water circuits/tanks for calcification and biofilm

● Status of cooling coils for corrosion

● Decalcification and/or disinfection

Important

As a preventive measure, contact LivaNova service personnel to schedule a maintenance check of the water tank cooling coils if you observe either of the following:

● Dark gray liquid is observed during the water circuit disinfection process.

● Excessive hydrogen peroxide consumption is observed during the daily

monitoring of hydrogen peroxide concentration.

Note: The rate of decrease in hydrogen peroxide concentration is expected to vary by device, and depends on several factors such as age or overall condition of the device, past maintenance practices, and local water conditions.

Important

The expected service life of the Heater-Cooler System 3T is 10 years. Use of the device beyond the expected service life, improper maintenance practices, or the incorrect use of disinfection and water preservation chemicals may lead to excessive corrosion damage of the water circuit components.

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Maintaining the heater-cooler Maintenance schedule and checklists

Record or estimate the operating hours

1 Where required by local regulations, record the operating hours of the heater-

cooler.

1 If local regulations do not require tracking of operating hours, LivaNova

recommends estimating the operating hours.

Schedule a maintenance check

 Schedule a maintenance check with a LivaNova service technician every

1,000 operating hours or every 12 months, whichever comes first.

6.2.5 Checklist: Proper disposal

Dispose of the heater-cooler and/or accessories according to your local environmental regulations and hospital policy

1 Dispose of used single-use items according to local environmental regulations

and the manufacturer’s instructions. Wear appropriate personal protection equipment (PPE) while disposing of these items.

1 The heater-cooler must not be disposed of in accordance with Directive

2012/19/EU or its national transpositions as the system is to be regarded as potentially infectious at the end of its service life.

1 Dispose of all heater-cooler accessories according to your hospital’s policy,

local environmental regulations, and the accessories’ instructions.

1 Only refrigerant systems experts are authorized to dispose of the cooling

circuit’s refrigerant (CFC-free HFC-[hydrofluorocarbons]) refrigerant. The refrigerant system service information is contained on the refrigerant system label.

1 As required by European Directive 93/42 and/or local regulation

98 CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Maintaining the heater-cooler

Cleaning and disinfecting external surfaces, connectors, and fittings

6.3 Cleaning and disinfecting external surfaces, connectors, and fittings

Cleaning and disinfecting schedule

● After every use, clean and disinfect the device surfaces

● Upon every connection, disinfect the tubing connectors on the heater-cooler

● Upon every connection, disinfect the fittings and connectors on the tubing

Important

● Make sure the CAN jack cover is closed before cleaning and disinfecting.

● Use only disinfectant wipes and sprays that are approved for use with the

heater-cooler. See the table below for a list of approved cleaning supplies.

Approved pre-soaked disinfectant wipe

Product name Manufacturer

CaviWipes Metrex

Approved disinfectant spray

Product name Manufacturer

CaviCide Metrex

CP_IFU_16-XX-XX_USA_021

Heater-Cooler System 3T • Maintaining the heater-cooler

Disinfect

Cleaning and disinfecting external surfaces, connectors, and fittings

6.3.1 Cleaning and disinfecting heater-cooler external surfaces

Summary of steps you will complete in this section:

1 Clean and disinfect the vacuum gauge

2 Clean all accessible device surfaces

3 Disinfect all accessible device surfaces

Clean and disinfect the vacuum gauge

 1 Using only approved disinfectant

wipes, clean the vacuum gauge,

removing any surface contamination and liquid spills.

 2 Using only approved disinfectant

wipes, disinfect the vacuum

gauge.

Important

Using other disinfectants may result in damage or a shortened lifetime of the gauge face.

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TANK VACUUM

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TANK VACUUM

100

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100 CP_IFU_16-XX-XX_USA_021

Livanova 3T User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction

1.1 Introduction

1.1.1 Device summary

1.1.2 Indications for use

1.1.3 Contraindications

1.1.4 Legal disclaimer

1.1.5 About these operating instructions

1.1.6 Symbols used in these operating instructions

1.1.7 The chapters in these operating instructions

1.1.8 Terminology and abbreviations

1.1.9 Requirement for filtered tap water

2 Safety

2.1 Safety information

2.1.1 General safety

2.1.2 Information on diffusion of hydrogen peroxide through the oxygenator heat exchanger

2.1.3 Procedural safety

2.1.4 Electrical safety

2.1.5 Integrating the HC3T into your facility

3 System description

3.1 General description

3.1.1 Device summary

3.1.2 System components

3.1.3 Explanation of the heater-cooler circuits and tanks

3.2 Structure of the heater-cooler

3.2.1 Heater-cooler overview

3.2.2 Heater-cooler control panel overview

3.2.3 Control panel S5/C5 System

4.1 General technical requirements

4.1.1 General use requirements

4.1.2 Materials you will need (not provided with the heater-cooler)

4.2 Conducting any required disinfection and maintenance

4.3 Connecting the procedural tubing

4.4 Connecting the potential equalization cable and the power supply

4.5 Connecting the aerosol collection set

4.6 Connecting to the S5/C5 System (if applicable)

4.7 Filling and mixing water tanks

5.1 Positioning the heater-cooler in the OR

5.2 Connecting the procedural tubing to external devices

5.3 Powering on and checking the panel

5.4 Performing a functional check prior to operation

5.5 Priming the complete circuit

5.6 Using the device controls during a procedure

5.6.1 Checking the vacuum

5.6.2 Opening and closing the circuit valves

5.6.3 Using the circuit controls

5.7 Completing a procedure

5.7.1 Drain and disconnect tubing

5.7.2 Emptying and/or disposing of the aerosol collection set

5.7.3 Conducting any required maintenance according to schedule

6.1 General maintenance precautions

6.1.1 Safety instructions for routine maintenance

6.2 Maintenance schedule and checklists

6.2.1 Schedule: Disinfection and maintenance

6.2.2 Checklist: Daily or with every use

6.2.3 Checklist: Mechanical checks

6.2.4 Checklist: Regular maintenance from LivaNova

6.2.5 Checklist: Proper disposal

6.3 Cleaning and disinfecting external surfaces, connectors, and fittings

6.3.1 Cleaning and disinfecting heater-cooler external surfaces