Heater-Cooler System 3T Operating Instructions

Heater-Cooler System 3T • Operating Instructions Copyright © 2007-2020 LivaNova Deutschland GmbH Lindberghstrasse 25 D-80939 Munich, Germany Tel.: Fax: 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®...

Heater-Cooler System 3T • Table of contents System description 3.1 General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 3.2 Structure of the heater-cooler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Preparing the heater-cooler for a procedure 4.1 General technical requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 4.2 Conducting any required disinfection and maintenance . . . . . . . . . . . . . . . . . 36 4.3 Connecting the procedural tubing . . . . . ....

Heater-Cooler System 3T • Table of contents 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...

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 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...

Heater-Cooler System 3T • Introduction Introduction 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...

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...

Heater-Cooler System 3T • Introduction Introduction 1.1.7 The chapters in these operating instructions 1 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. 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...

Heater-Cooler System 3T • Introduction Introduction 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. 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...

Heater-Cooler System 3T • Introduction Introduction 1.1.8 Terminology and abbreviations Terminology Abbreviated term Full term Stöckert Heater-Cooler System 3T Stöckert S5 System, modular heart-lung machine Sorin Compact 5 System, compact heartlung machine Abbreviations Abbreviated term Full term Allowable Limit Controller Area Network (CAN bus) Colony Forming Unit Electromagnetic Compatibility Registration number of the United States Environmental Protection Agency (applies to the United States only) Heart-Lung Machine Non-tuberculous Mycobacteria Operating Room Radio Frequency Unique Device...

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 ≥ 107 CFU/cm2 of effective filtration area.1 For instructions on filter management and disposal after the specified use period please refer to the manufacturer’s...