LivaNova 3T Heater-Cooler System User manual

Heater-Cooler System 3T
Operating Instructions

2 CP_IFU_16-XX-XX_USA_023
Heater-Cooler System 3T • Operating Instructions
Copyright © 2007-2023
LivaNova Deutschland GmbH
Lindberghstrasse 25
D-80939 Munich, Germany
Tel.: [phone]
Fax: [phone]
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:
Operating Instructions
Version 07/2023 - CP_IFU_16-XX-XX_USA_023
Firmware version No. 2.07
LivaNova USA, Inc.
14401 West 65th Way
Arvada, CO 80004
phone: [phone]
phone: [phone]
fax: [phone]

Heater-Cooler System 3T • Table of contents
CP_IFU_16-XX-XX_USA_023 3
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

Heater-Cooler System 3T • Table of contents
4CP_IFU_16-XX-XX_USA_023
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

CP_IFU_16-XX-XX_USA_023 5
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.

Heater-Cooler System 3T • Introduction
Introduction
6CP_IFU_16-XX-XX_USA_023
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.
0
20
40
TANKVACUUM
CALIBRATEDFOR
VERTICALPOSITION
MAXPRESSURE 100kPa
pascals
60
80
100
C
°
C°C°
C
°
C°
C°
12
C°C°C°
C°C°C°
12
Cardioplegia circuit
Patient 1 circuit
Patient 2 circuit
Control panel

Heater-Cooler System 3T • Introduction
Introduction
CP_IFU_16-XX-XX_USA_023 7
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.
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.

Heater-Cooler System 3T • Introduction
Introduction
8CP_IFU_16-XX-XX_USA_023
1.1.6 Symbols used in these operating instructions
NOTE: Provides additional information that can help you better understand a
specific instruction of function.
1Checkmark: Used to indicate an item to check before or after completing a task.
These items are for reference and do not replace detailed 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.
i

Heater-Cooler System 3T • Introduction
Introduction
CP_IFU_16-XX-XX_USA_023 9
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.

Heater-Cooler System 3T • Introduction
Introduction
10 CP_IFU_16-XX-XX_USA_023
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.