sorin 3T User manual

Heater-Cooler System 3T
Operating Instructions

CP_IFU_16-XX-XX_USA_015
Heater-Cooler System 3T • Operating Instructions
Copyright © 2007 - 2015
SORIN GROUP DEUTSCHLAND GMBH
Lindberghstrasse 25
D-80939 Munich, Germany
phone: +49 - 89 - 32301-0
fax: +49 - 89 - 32301-555
All rights reserved. No part of this manual may be reproduced or copied in any form or by any
means - be it graphic, electronic or mechanical, including photocopying, typing, or information
and retrieval systems - without written permission of SORIN GROUP DEUTSCHLAND GMBH.
The name “Stöckert®” is a Registered Trademark.
“Clorox®” is a Registered Trademark of the Clorox Company.
“Minncare®” is a Registered Trademark of the Minntech Corporation, a Cantel Medical Company.
Pall-Aquasafe™is a Registered Trademark of the Pall Corporation
Indications for use
The Stöckert Heater-Cooler System 3T is used with a Stöckert S3 heart-lung machine and/or any
other heart-lung-machine featuring a separate temperature control for extracorporeal
perfusion of durations of up to 6 hours.
!
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:
Sorin Group USA, Inc.
14401 W. 65th Way, Arvada, CO 80004,
phone: [phone]
phone: [phone]
fax: [phone]
Operating Instructions
Version 09/2015 - CP_IFU_16-XX-XX_USA_015
Firmware version No. 2.XX

Heater-Cooler System 3T • Table of Contents
CP_IFU_16-XX-XX_USA_015 1
Table of Contents
1Introduction
1.1 About these operating instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1
1.1.1 Symbols used in these operating instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1
1.1.2 The chapters in these operating instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2
2Safety
2.1 Safety requirements and certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1
2.2 Regulations and safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2
2.2.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2
Instructions for use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2
2.2.2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2
2.2.3 General safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3
2.2.4 Operational safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4
2.2.5 Electrical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5
2.2.6 Safety instructions for routine maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6
2.3 Safety features of the heater-cooler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7
3 System description
3.1 General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1
3.1.1 Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1
Standard components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1
Optional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1
3.2 Structure of the heater-cooler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2
3.2.1 Complete overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2
3.2.2 Overview - control panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4
3.2.3 Overview - control panel S5/C5 System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5

Heater-Cooler System 3T • Table of Contents
2CP_IFU_16-XX-XX_USA_015
4 Installation
4.1 Preparing the installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.1
4.1.1 General and technical requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.1
4.2 Performing the installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.2
4.2.1 Placing the heater-cooler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.2
4.2.2 Water connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.3
Connecting tubings to the water circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.3
Connecting the overflow tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.5
Opening/closing the venting valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.7
Disconnecting the tubings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.7
4.2.3 Electrical connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.8
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.8
4.2.4 Operation with the S5/C5 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.9
5Operation
5.1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.1
5.2 Filling the water tanks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.2
5.3 Powering up and configuring the heater-cooler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.6
5.3.1 Power-up and self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6
5.3.2 Displays after power-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.7
Displays after successful completion of the self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.7
Error displays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.8
5.3.3 Function check prior to operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.9
Check list: check during installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.9
Check list: check during and after powering up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.9
5.4 Operation of the heater-cooler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.10
5.4.1 Adjusting the set values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.10
Adjusting the set values on the heater-cooler. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.10
5.4.2 Starting and stopping circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.11
Priming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.11
The cardioplegia circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.11
The patient circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.12
5.5 Alarm and error displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.13
5.5.1 Alarm displays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.13
Water level alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.13
Temperature alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.14
5.5.2 Error displays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.15
Error displays on the heater-cooler (base unit). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.15

Heater-Cooler System 3T • Table of Contents
CP_IFU_16-XX-XX_USA_015 3
6 Routine maintenance
6.1 General instructions for maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.2
6.1.1 Safety instructions for routine maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.2
6.1.2 Timelines for disinfection and related tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3
6.1.3 Regular maintenance checks by authorized service technicians . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.4
6.1.4 Disposal in accordance with environmental regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.4
6.2 Cleaning and disinfection of surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.5
Required material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.5
6.3 Disinfection of the water circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.6
Required material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.7
6.3.1 Disinfection procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.8
6.4 Changing the water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.12
6.5 Preparing the heater-cooler for storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.13
6.6 Cleaning the interior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.14
6.7 Instructions for handling the tubings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.15
6.8 Safety checks and functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.16
6.8.1 Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.16
6.9 Check lists: maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.17
Check list: daily or every time the device has been used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.17
Check list: additional maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.17
7Appendix
7.1 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1
7.1.1 Dimensions, weights, operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1
7.1.2 Electrical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1
7.1.3 General performance data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2
7.1.4 Information about Global Warming Potentials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3
7.2 Labeling and tagging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.4
7.3 Part numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.5
7.4 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.6
7.5 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.6
7.6 Information about electromagnetic compatibility (EMC) for 240 V ~ and 208 V ~ System . . . . . . . . . . . . . 7.7
7.6.1 Guidance and manufacturer's declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.7
7.7 Information about electromagnetic compatibility (EMC) for 120 V ~ System . . . . . . . . . . . . . . . . . . . . . . . . 7.12
7.7.1 Guidance and manufacturer's declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.12
7.8 Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.16

Heater-Cooler System 3T • Table of Contents
4CP_IFU_16-XX-XX_USA_015
Notes:

Heater-Cooler System 3T • Introduction
CP_IFU_16-XX-XX_USA_015 1.1
1 Introduction
1.1 About these operating instructions
These operating instructions are solely intended for qualified perfusionists as the basis for using,
operating, and maintaining the heater-cooler. Therefore, in the interest of the safety of both, the
patient and the operator:
!
Read these operating instructions thoroughly before using the heater-cooler for the first time!
These operating instructions provide valuable information even for the experienced user. Apart from
purely describing operational steps they also contain information on how to avoid dangerous
situations and errors. Moreover, they supply instructions for quick troubleshooting.
1.1.1 Symbols used in these operating instructions
The symbols are intended to help the user find special text passages. The meaning of the symbols is as
follows:
!Danger! Failure to pay attention may cause danger to the patient’s
and/or the operator’s life and health.
!Warning! Failure to pay attention may cause damage to the machine
or other equipment.
✓A check list for a quick and safe follow up on whether operational
steps have been carried out completely.
◗Primary list (main groups)
➜Secondary list (subgroups)

Heater-Cooler System 3T • Introduction
1.2 CP_IFU_16-XX-XX_USA_015
1.1.2 The chapters in these operating instructions
In chapter... you will find the following information:
1 Introduction ➜Symbols used in these operating
instructions
➜Overview on chapters (this table)
2Safety ➜Important safety instructions for the
operation and maintenance of the heater-
cooler
3Systemdescription ➜Complete overview
➜Delivery scope
4 Installation ➜Installation of the base unit
5Operation ➜Initial operation
➜Function checks
➜Usage
➜Instructions for troubleshooting
6 Routine maintenance ➜Cleaning and disinfecting
➜Maintenance intervals and instructions
➜Safety checks
7Appendix ➜Specifications
➜Part numbers
➜Warranty

Heater-Cooler System 3T • Safety
CP_IFU_16-XX-XX_USA_015 2.1
2Safety
2.1 Safety requirements and certification
The Heater-Cooler System 3T is a class IIb medical device (MDD 93/42/EEC). A Declaration of
Conformity has been issued for the heater-cooler.
This device complies with the requirements of EU Directive 93/42/EEC
of the European Council for Medical Devices.

Heater-Cooler System 3T • Safety
2.2 CP_IFU_16-XX-XX_USA_015
2.2 Regulations and safety instructions
2.2.1 Intended use
!
◗In accordance with the applicable regulations, the heater-cooler is intended for use with a
Stöckert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a
separate temperature control for extracorporeal perfusion of durations of up to 6 hours. The water
circuits are used for cooling/heating blood (in the oxygenator), hypothermia blankets or
cardioplegic solutions.
Instructions for use
◗Any use beyond this specification is not in accordance with the regulations and
SORIN GROUP DEUTSCHLAND GMBH will not assume any liability for damage in such a case. Usage
in accordance with regulations also includes compliance with the operating instructions, as well as
repair and maintenance according to the maintenance instructions.
◗Relevant accident prevention measures according to existing local policy and employees’ health
and safety regulations must be complied with. SORIN GROUP DEUTSCHLAND GMBH will not
assume any liability for damage due to non-compliance with these regulations.
◗SORIN GROUP DEUTSCHLAND GMBH will not assume any liability for injuries and/or damage
caused by failure to observe the safety instructions or by the operator not taking due care. This
also applies if the operator’s duty to take due care has not been specifically expressed to the user.
2.2.2 Contraindications
◗There are no known contraindications for the heater-cooler.
The attending physician is solely responsible for the use of the system.

Heater-Cooler System 3T • Safety
CP_IFU_16-XX-XX_USA_015 2.3
2.2.3 General safety instructions
◗The heater-cooler has been designed according to current state-of-the art technology and accepted
safety standards. Although this is the case, danger may arise for the patient, the user or for other
equipment during operation.
◗The heater-cooler may only be used by trained and qualified perfusionists and may only be
maintained by trained and qualified personnel.
!
◗The heater-cooler must not be used in the presence of explosive substances.
Usage in
accordance with:
See chap. 2.2.1 on
page 2.2
◗The heater-cooler may only be operated when the equipment is in good technical running order
and, when used, in accordance with the applicable regulations and the operating instructions. Be
sure to take note of cautions and warnings.
◗The operating instructions must be available close to the heater-cooler at all times. Incomplete or
illegible operating instructions must be replaced immediately.
◗According to the European Directive 93/42 and the national standards based on this directive, the
heater-cooler must be subjected to a regular maintenance check by an authorized service
representative. The maintenance check must be performed after every 1,000 operating hours or at
least once every 12 months, whichever comes first.
◗In addition to the operating instructions, the relevant legal, general and binding regulations
concerning the prevention of accidents must be observed.
◗In order to take situations into account which are clinic-specific and outside of normal routines,
e.g. certain working procedures, the operating instructions must be supplemented with relevant
instructions (supervision and registration requirements, etc).
◗Personnel operating the heater-cooler must have acquainted themselves thoroughly with the
operating instructions prior to working on the system!
◗If modifications affecting safety or system performance are noticed when the heater-cooler is not in
use in the O.R., power it down immediately and have it checked by an authorized service
technician.
◗Do not perform any modifications or extensions to the heater-cooler unless they have been tested
and approved by SORIN GROUP DEUTSCHLAND GMBH, or else SORIN GROUP DEUTSCHLAND GMBH
cannot assume any liability or responsibility.
◗Keep the heater-cooler clean! Doing so will prevent possible contact errors and faults due to dirt.
◗Remove water spills from the OR floor using suitable disinfectants.

Heater-Cooler System 3T • Safety
2.4 CP_IFU_16-XX-XX_USA_015
2.2.4 Operational safety
◗Prior to working with the heater-cooler, the user must have thoroughly read the operating
instructions and have become familiar with the device functions!
◗Ensure that the heater-cooler is placed on a horizontal surface and the castor brakes have been
locked prior to operation.
◗Pay attention to hand hygiene and protective barriers by disinfecting your hands and using
disposable gloves prior to connecting tubing or filling the tanks.
◗Use filtered tap water that has been filtered by using e.g. a disposable Pall-Aquasafe water filter
with an 0.2 µm membrane (Pall part reference in the U.S.: “AQINA”; “AQIN” in other countries).
Alternatively, use a filter of equivalent performance that meets the requirements for bacterial
retention according to the ASTM standard*, i.e. which retains Brevundimonas diminuta to
≥10
7CFU/cm2of effective filtration area.
* (American Standard Test Method F838-05 “Determining Bacteria Retention of Membrane Filters Utilized for Liquid
Filtration”)
◗If available, use demineralized tap water.
◗Check the water level of the tanks prior to each operation. Only operate the heater-cooler, if the
water level is sufficient, i.e., is above the minimum water level (one segment of the bar graph
display).
!
◗Prior to operation, check all cables, tubings, connectors and other accessories in view of correct
connections, leaks and proper function. Replace all damaged components at once.
◗Check the actual temperature displays on the heater-cooler regularly.
!
◗Check the patient’s blood temperature and the temperature of the cardioplegic solution with an
appropriate temperature measurement system regularly, independent of the displays on the
heater-cooler (e.g. at the HLM).
!
◗For emergencies, e.g. in case of a total failure, ensure that a replacement with compatible
connectors is ready for operation.
◗Activate the pumps of the primed and filled system prior to its first operation. Watch the water level
display on the heater-cooler control panel and monitor the connected heat exchanger (e.g.
oxygenator, heating/cooling blanket). A leakage in a water circuit will influence the water level in
the connected tank.
◗Do not use self-closing tubing connectors. Compared to “open” connectors, self-closing
connectors reduce the water flow.
◗Ensure that the cables and tubings are laid out as straightly as possible and do not kink or twist
them. Kinked or twisted cables or tubings could pose a hazard for personnel (who could stumble,
or get caught on the tubing).
◗A primed and filled heater-cooler must not exceed a total weight of 125 kg (275.5 lbs.).

Heater-Cooler System 3T • Safety
CP_IFU_16-XX-XX_USA_015 2.5
◗Ensure optimum ventilation at the ventilation grills and the fan. Insufficient ventilation may result
in excessive heating of the heater-cooler.
◗The minimum distance of 70 cm to the wall or other devices must be observed!
◗Modifications or extensions to the device, as well as the use of spare parts which have not been
tested and approved by SORIN GROUP DEUTSCHLAND GMBH, may have negative effects on the
safety and function of the system. SORIN GROUP DEUTSCHLAND GMBH cannot accept any liability
or responsibility in such cases.
◗Accessories and supplementary devices which have not been tested and approved by
SORIN GROUP DEUTSCHLAND GMBH must prove that their use does not pose a safety hazard (see
chap. 7.4 “Accessories” on page 7.6).
2.2.5 Electrical safety
◗Accessories and supplementary devices must comply with the relevant IEC or ISO standards (e.g.
IEC 60950 regarding information technology equipment). In addition, any configuration must meet
the requirements for medical electrical systems (see IEC 60601-1-1 or paragraph 16 of IEC 60601-1,
3rd edition). Any person connecting additional devices to medical electrical equipment is
considered a system configurer and is thus responsible for ensuring that the system meets the
standard-related requirements for systems. Please note that local legislation takes precedence
over the above-mentioned standard-related requirements.
◗Check the functional safety of all electrical connections, cables and sockets regularly!
◗Mains power quality should be that of a typical commercial or hospital environment.
!
◗The heater-cooler must be connected to a power supply network with protective conductor (earth)
to protect the device against electric shock.

Heater-Cooler System 3T • Safety
2.6 CP_IFU_16-XX-XX_USA_015
2.2.6 Safety instructions for routine maintenance
◗Routine maintenance work must only be performed by qualified personnel.
◗The heater-cooler must be cleaned completely prior to operating it for the first time.
◗The water circuits must be disinfected prior to operating the heater-cooler for the first time and
when placing the system in storage. The disinfection cycle must then be repeated every 14 days
(even on systems in storage).
!
◗Disconnect the heater-cooler from the power supply prior to performing routine maintenance.
◗Do not fail to observe the regulations concerning routine maintenance, as well as the prescribed
maintenance intervals stated in these operating instructions.
◗Ensure that no liquids or cleaning agents enter the housing through the vents or other openings.
◗Use recommended cleaning agents and disinfectants. Follow the instructions of the chemical
manufacturer for storage and use condition.
◗Repair work on the heater-cooler must only be carried out by authorized service personnel. Only
original spare parts from SORIN GROUP DEUTSCHLAND GMBH must be used in order to guarantee
the proper functioning of the system.
◗The repair work of the cooling circuit and the disposal of the refrigerant must only be performed by
an expert for refrigerant systems. Please see chap. 6.1.3 “Regular maintenance checks by
authorized service technicians” on page 6.4.
◗Routine decalcification is not required. If needed, decalcification must be carried out by
authorized service personnel.

Heater-Cooler System 3T • Safety
CP_IFU_16-XX-XX_USA_015 2.7
2.3 Safety features of the heater-cooler
◗The heater-cooler runs a self-test during power-up. Check whether all LEDs, the 7-segment displays
and the beep alarm function correctly.
◗Visual and audible alarms indicate when an internal error has occurred.
◗The water pumps are stopped if the water level is too low. This is indicated by a corresponding
alarm.

Heater-Cooler System 3T • Safety
2.8 CP_IFU_16-XX-XX_USA_015

Heater-Cooler System 3T • System description
CP_IFU_16-XX-XX_USA_015 3.1
3 System description
3.1 General description
The Stöckert Heater-Cooler System is an independent (i.e. independent of the water supply)
3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as:
◗Two circuits for the patient (for the heating/cooling blanket, the oxygenator),
common temperatures ranging from 2°C to 41°C, tank volume 6 l
◗Interchangeable heating/cooling circuit for cardioplegia,
temperatures ranging from 2°C to 10°C (cooling) and/or from 15°C to 41°C (heating),
volume 2 x 3 l
If required, the circuits for the patient and the circuit for cardioplegia can be switched off separately, in
order to increase the activated functional group’s heating and/or cooling performance.
3.1.1 Components
The common delivery scope contains the standard components stated below. For further components
(“optional components”), please contact SORIN GROUP DEUTSCHLAND GMBH, or your local
SORIN GROUP DEUTSCHLAND GMBH distributor.
Standard components
◗Heater-cooler base unit
◗3 pcs. tubing connectors 1/2", 90° angle, with venting valve
◗3 pcs. tubing connectors 1/2", straight
◗Potential equalization cable
◗Operating instructions
Optional components
◗Heating/cooling blanket (dim. 55 x 150 cm)

Heater-Cooler System 3T • System description
3.2 CP_IFU_16-XX-XX_USA_015
3.2 Structure of the heater-cooler
3.2.1 Complete overview
Fig. 1: Overview
1 32
4
5 6 7 8 910 12
15
16
19
13
11
18 17
14
20

Heater-Cooler System 3T • System description
CP_IFU_16-XX-XX_USA_015 3.3
Item Designation Function
1Mains power switch ➜Powering the heater-cooler up/down
➜Integrated automatic cutout
2Control panel ➜For separated operation and
configuration of the two functional
groups (3 water circuits)
– patient circuits and
– cardioplegia circuit
3Filler neck with cover ➜For filling all tanks with filtered tap
water.
4CAN-Bus connector with cover
5Outlet patient circuit 2
with venting valve
➜All inlets and outlets with fast
(Hansen-type) connectors 1/2"
6Inlet patient circuit 2
7Outlet patient circuit 1
with venting valve
8Inlet patient circuit 1
9Outlet cardioplegia circuit
with venting valve
10 Inlet cardioplegia circuit
11 Drain valve of the patient circuits
➜Emptying of the tanks
12 Drain valve of the cardioplegia circuit
13 Overflow outlet
14 Overflow bottle (with tubing) ➜For collecting the excess water
(during filling)
15 Fan
➜Ventilation of the heater-cooler
16 Ventilation grill
17 Potential equalization point ➜Connection of the potential
equalization cable
18 Power cable ➜Power supply of the heater-cooler
19 Castors ➜Front castors with brakes
20 Bumper Mounting upon delivery (by Sorin service
staff).

Heater-Cooler System 3T • System description
3.4 CP_IFU_16-XX-XX_USA_015
3.2.2 Overview - control panel
The control panel manages all control and monitoring functions of the heater-cooler. These are:
◗Adjusting the set values,
◗Starting and stopping the pumps,
◗The display of all set and actual temperatures,
◗The display of the water level and the alarm.
Fig. 2: Control panel
°C °C °C
°C °C °C
1 2
36.8
36.838
37
7
5
24
25
21 22 23
33
32
26 27 28 29
30
31
Item Designation Function
21 Cardioplegia cooling circuit elements
➜Displays and controls all settings of
the individual circuits
22 Cardioplegia heating circuit elements
23 Elements of the patient circuits
24 7-segment displays Actual temperatures ➜Displays the actual and the set
temperatures
25 7-segment displays Set temperatures
26 Keys Lower set temperature ➜for increasing and/or decreasing the
set value gradually (in steps)
27 Keys Raise set temperature
28 Keys Standby ➜Switching on and off the functional
group (standby mode)
29 Key Audio alarm off ➜Switches off the audio alarm (in case
of alarm) for a maximum of 2 minutes,
press the key again to switch the
alarm back on.
30 Keys Circuit Start/Stop
(patient circuits)
➜Starting and stopping the circuit in
question individually.
31 Keys Circuit Start/Stop
(cardioplegia circuit)
heating tank: red dot
cooling tank: blue dot
➜Starting and stopping the circuit as
well as switching between the
heating and the cooling tanks.
32 Bar graph display Water level ➜Display of the water level
33 Display Alarm ➜Red LED lights up in case of alarm