Elios2 Patient Monitor Operating Manual Edition 1 Nov 2011

© Copyright by KONTRON MEDICAL SAS, 2001 ALL RIGHTS RESERVED PRINTED IN FRANCE The information contained in this publication may not be used for any purpose other than that for which it was originally supplied. The publication may not be reproduced in part or in whole without written consent of KONTRON MEDICAL SAS. In order to maintain and improve standards of manufacturing, methods of functioning and reliability, KONTRON MEDICAL SAS equipments are periodically reviewed. For this reason, the content of this publication is subject to change without any notice. The equipment described is manufactured by: KONTRON MEDICAL S.A.S. Boite Postale 97 78373 PLAISIR CEDEX FRANCE Internet: www.kontronmedical.com

Revision: July, 2001

TABLE OF CONTENTS Section 1 Introduction Chapter 1 What You Should Know Manual Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changes in Default Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Prescription Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1-1 1-1 1-1 1-2 1-2

Chapter 2 Warnings and Precautions Minimizing Electrosurgical Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How Electrosurgery Interference Affects Patient Monitoring . . . . . . . . . . . . . . . . Conduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Explosion Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Connection of Other Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Use of Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Responsibility of Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrode and Transducer Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General Use of Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-1 2-1 2-2 2-3 2-3 2-3 2-3 2-3 2-4 2-4 2-6 2-6

Chapter 3 System Description Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Features and Capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monitor and Main Processing Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Chapter 4 Installation Unpacking and Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Setting Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Installation Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Site Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Wall Mounting Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Cable Interconnection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Grounding the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Equipotential Grounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Electrosurgery, Diathermy and Defibrillation Protection . . . . . . . . . . . . . . . . . . . . 4-5 Accidental Wetting of the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Patient Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Recommended Setup for Neonatal Applications . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Chapter 5 Maintenance And Cleaning Cleaning the Elios2 Bedside Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Calibration and Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Chapter 6 Controls and Functions Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 AC Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Power Interruptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1 Main Screen Display Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Global Header Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Patient Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Main Display Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 Quick Keys Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 Main Processing Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7 Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11 Module Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 Inserting a Module into the Module Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 Working With Menus and Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14 Types of Menus and Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14 Moving Between Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16 Common Panel Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17 Other Panel Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18 Accessing Menus and Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19

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Section 2 Patient Monitoring Procedures Chapter 7 Alarms General Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Alarm Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Visual Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Audio Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Alarm Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Alarm Response Priority Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Upgrading of Alarm Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Setting Up Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 Alarm Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 Alarm Silence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 Alarms Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 Latched Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5 Alarm Volume Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 Multi-Parameter Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 SpO2 Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 Asystole Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 Alarm Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 Accessing the Alarm Status Dialog Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 What To Do When an Alarm Occurs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9 Alarm Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9 Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10 Chapter 8 Setting Up the Patient Display Display Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adjusting Sweep Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selecting a Special Display Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cardio Respiratory Graph (CRG) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CRG Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8-1 8-2 8-2 8-3 8-4

Chapter 9 Connecting a Patient to the Elios2 Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Admission, Discharge and Transfer Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The ADT Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Patient Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Clinibase Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9 Setting up Monitoring Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10 Showing/Hiding the Monitoring Profile on the Main Screen . . . . . . . . . . . . . . . . 9-11 Changing the Position of a Monitoring Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11 Clearing a Monitoring Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12 Chapter 10 Reviewing Patient Data Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1 Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 Chart Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 Chart Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4 Viewing Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5 Full Disclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7 Ten Minute Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7 Ten Second Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12 Remote View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15 Setting Remote Bed Alarms to Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17 Printing and Recording Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17 Returning to Local Viewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17 Event Strips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18 Chapter 11 Performing ClInical Calculations Viewing the Calculation Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hemodynamics Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Respiratory Mechanics Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Oxygenation Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Renal Clearance Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11-1 11-3 11-4 11-5 11-6

Chapter 12 Performing Medication Calculations Accessing Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Using The Medication Calculation Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Infusion Rate Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Drug Concentrate Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Injection Amount Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12-1 12-2 12-3 12-4 12-6

Chapter 13 Recording Vital Sign Data Waveform Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1 IV

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Recorder Status Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Anatomy of the Recorder Strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assigning a Chart Recorder to the Elios2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Recording Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manual Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Vital Sign Alarm Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Multi-ECG Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Selective Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . All Waveform Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13-3 13-3 13-5 13-5 13-5 13-5 13-6 13-6 13-7

Section 3 Vital Signs Monitoring Chapter 14 ECG Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1 Multi Lead ECG/RSP Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2 Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2 Adult Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3 Neonatal Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-5 ECG Monitoring Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-5 ECG Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-6 Accessing the ECG Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-7 Setting ECG Leads & Gain Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-8 Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-8 Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-8 Show Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-9 Set All to Same Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-9 Setting ECG Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-10 Activating ECG Alarms and Setting ECG Alarm Limits . . . . . . . . . . . . . . . . . . 14-10 Setting ECG Alarm Response Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-12 Setting ECG Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-14 Setting QRS Tone Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-15 Detecting a Pacemaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-17 Setting the Heart Rate Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-18 Selecting a Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-20 Chapter 15 Arrhythmia Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accessing the Arrhythmia Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activating and Setting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activating and Setting Individual Arrhythmia Alarms . . . . . . . . . . . . . . . . . . . . .

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Activating Arrrhythmia Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15-9 Chapter 16 ST Segment Analysis Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accessing the ST Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activating ST Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting ST Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting ST Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting ST Alarm Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Manually Determining the ISO an ST Measuring Points . . . . . . . . . . . . . . . . . . . Determining ST Variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16-2 16-2 16-3 16-3 16-3 16-5 16-6 16-7 16-8

Chapter 17 Respiration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-1 Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-2 Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-2 Accessing the Resp Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-3 Setting Respiration Leads and Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-3 Setting Respiration Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-5 Setting Resp Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-5 Setting the Respiration Alarm Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-7 Setting Resp Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-8 Setting the Heart Rate Coincidence Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17-10 Activating and Deactivating Respiration Monitoring . . . . . . . . . . . . . . . . . . . . . . . 17-12 Chapter 18 Invasive Blood Pressures (BP) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-1 Dual BP and CO/2 TMP Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-3 Preparatory Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-4 BP Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-4 Accessing the BP Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-5 Zeroing BP Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-5 Selecting the BP Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-7 Setting BP Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-8 Setting BP Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-8 Setting BP Alarm Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-10 Setting BP Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-12 Deriving the PCWP Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-14 Measuring the Central Venous Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-15

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Activating and Deactivating BP Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-17 Chapter 19 Cardiac Output (C.O.) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-1 Clinical Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-2 Preparatory Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-2 Measuring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-3 Accessing the Cardiac Output Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-3 Acquiring Data for Determining Cardiac Output . . . . . . . . . . . . . . . . . . . . . . . . . 19-4 Defining Catheter Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-6 Entering Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-7 Editing Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-8 Cardiac Output Fick Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19-10 Chapter 20 Temperature Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparatory Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Temperature Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accessing the Temperature Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting Temperature Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting Temperature Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting Temperature Alarm Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting Temperature Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activating Temperature Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting Delta Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20-1 20-1 20-2 20-2 20-3 20-3 20-5 20-6 20-7 20-8

Chapter 21 Non-Invasive Blood Pressure (NIBP) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-1 NIBP Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-2 Limitations of the Oscillometric Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-3 Preparatory Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-4 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-4 Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-5 Accessing the NIBP Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-6 Setting Reading Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-6 Selecting the Cuff Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-9 Setting NIBP Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-10 NIBP Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-10 Setting NIBP Alarm Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-12 Setting NIBP Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-13 Activating NIBP Measuring and Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21-14

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Chapter 22 Pulse Oximetry (Sp02) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-1 Pulse Oximetry (SpO2) Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-2 Patient Preparation Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-2 Interfering Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-3 Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-4 Accessing the Sp02 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-5 Setting Sp02 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-5 Setting Sp02 Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-5 Setting Sp02 Pulse Rate Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-7 Setting Sp02 Alarm Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-8 Setting Sp02 Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-10 Activating and Setting Sp02 Pulse Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-11 Setting Sp02 Response Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-13 Activating Sp02 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-14 Neonatal Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-14 Chapter 23 End Tidal CO2 (etCO2) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-2 CO2 Sensor (Mainstream) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-2 End Tidal CO2 (etCO2) Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-3 Patient Preparation Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-3 Cautions and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-4 Interfering Gasses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-5 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-6 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-6 Intubated Mainstream Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-7 Non-intubating Sidestream Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-8 Intubated Sidestream Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-9 Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-10 Accessing the EtCO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-10 Setting EtCO2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-11 Setting EtCO2 Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-11 Setting EtCO2 Alarm Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-13 Setting EtCO2 Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-14 Activating EtCO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-16 Service Calibration Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-16 Service Pneumatic Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-17 etCO2 Monitoring Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23-18

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Chapter 23A End Tidal CO2 (etCO2) Mainstream - NK901T Sensor Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-2 CO2 Sensor (Mainstream) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-2 End Tidal CO2 (etCO2) Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-2 Patient Preparation Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-3 Cautions and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-3 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-4 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-4 Intubated Mainstream Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-5 Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-6 Accessing the etCO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-7 Setting etCO2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-7 Setting etCO2 Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-7 Setting etCO2 Alarm Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-9 Setting etCO2 Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-10 Activating etCO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-11 Service Calibration Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-12 etCO2 Monitoring Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23A-13 UIM Auxiliary Devices Chapter 23B Uniport Interface Module (UIM) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23B-1 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23B-1 UIM Auxiliary Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23B-2 UIM Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23B-2 Cautions and Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23B-3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23B-4 Setting Up the Elios2 for Different Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23B-7 Chapter 23C Multigas Anesthesia Analyzer Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-2 Anesthetic Gas Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-2 Patient Preparation Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-3 Cautions and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-4 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-4 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-4 Anesthetic Gas Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-6 Patient Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-7

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Setting the Pump Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23B-4 Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-8 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-10 Module Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-10 Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23C-12 Chapter 24 Transcutaneous O2/CO2 (tcGas) Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . tcGas Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . tcGas Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accessing the tcGas Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting tcGas Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting tcGas Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting tcGas Alarm Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting tcGas Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activating and Deactivating tcGas Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24-1 24-1 24-2 24-2 24-3 24-3 24-5 24-6 24-8

Chapter 25 Ventilator Monitoring Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-1 Ventilator Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-1 Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-2 Ventilator Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-3 Setting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-4 Setting Ventilator Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-4 Setting Ventilator Alarm Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-5 Setting Ventilator Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-7 Activating and Deactivating Ventilator Monitoring . . . . . . . . . . . . . . . . . . . . . . . . 25-10 Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25-11 Chapter 26 Anesthetic Gas Monitoring Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-1 Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-1 EtCO2 Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-2 Accessing the EtCO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-2 Setting EtCO2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-3 Setting EtCO2 Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-4 Setting EtCO2 Alarm Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-6 Setting EtCO2 Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-8 Setting the Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-10 Activating EtCO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-11 O2, N2O, And Anesthetic Agent Monitoring Procedures . . . . . . . . . . . . . . . . . . . . 26-12

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Accessing the O2, N2O and Anesthetic Agent Menu . . . . . . . . . . . . . . . . . . . . . . . Setting O2, N2O and Anesthetic Agent Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting O2, N2O and Agent Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting O2, N2O or Agent Alarm Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting O2, N2O and Anesthetic Agent Display Options . . . . . . . . . . . . . . . . . . . . Selecting the O2, N2O and Anesthetic Agent Scale . . . . . . . . . . . . . . . . . . . . . . . . Activating Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activating O2 and N2O Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Activating Anesthetic Agent Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

26-13 26-13 26-13 26-15 26-17 26-19 26-20 26-20 26-21 26-22

Section 4 Appendixes Appendix A Accessories Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7 Appendix B Troubleshooting ECG/Respiration Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 Invasive Blood Pressure Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 Cardiac Output Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3 Errors in Measurement: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3 etCO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 Addendum for SW Version 3.0 New Features List of new features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ad3.0-1 Heart RateVariability (HRV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ad3.0-3

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SECTION 1 INTRODUCTION This section contains the following chapters: 1. What You Should Know 2. Warnings and Safety Precaution 3. System Description 4. Installation 5. Maintenance and Cleaning 6. Controls and Functions

Chapter 1 WHAT YOU SHOULD KNOW Manual Structure The manual is divided into four major sections. •

Section 1 introduces the Elios2 bedside monitor and provides a general overview of the system, including standard operating techniques.

•

Section 2 includes a general discussion of alarms. It also provides information about setting up the patient display, admission and discharge procedures and reviewing patient data.

•

Section 3 describes vital sign monitoring procedures performed by the Elios2 bedside monitor.

•

Section 4 includes appendixes referring to available accessories and troubleshooting.

Changes in Default Configuration This manual describes the standard default configuration of all parameter functions in the Elios2 bedside monitor as provided by KONTRON MEDICAL. This configuration can be changed according to your hospital’s needs by your Biomedical Engineering department, System Administrator or a KONTRON MEDICAL service engineer. If any deviation from the description provided in this manual is apparent, consult your hospital’s Biomedical Engineering department or System Administrator.

Intended Use The Elios2 bedside monitor is intended for use as a multi-parameter physiological patient monitoring system.

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The Elios2 bedside monitor can monitor ECG/Heart Rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration and noninvasive blood pressure. This effectively allows the Elios2 bedside monitor to monitor a wide range of patient conditions in many different areas of the hospital. Functions include display of multi-parameter waveforms, vital signs, alarm and status messages. The Elios2 bedside monitor is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. The following are examples of intended clinical applications: •

Critical care patients

•

Cardiac stepdown/telemetry units

•

Emergency departments

•

Intra-operative (anesthesia) monitoring

•

Post-anesthesia care

Prescription Notice Federal United States law restricts the sale and use of this instrument to qualified medical personnel only.

Compliance The Elios2 bedside monitor is designed to comply with the international safety requirements for medical electrical equipment IEC 60601-1, IEC 60601-1-2, IEC 60601-2-23, IEC 60601-2-27, IEC 601-2-34, and AAMI voluntary performance standards for cardiac monitors. European Directive 93/42/EEC classifies the Elios2 bedside monitor as a Class IIb device. The NIBP and SpO2 modules are classified as Type BF equipment. The ECG and Dual BP and CO/2 Tmp modules are classified as Type CF equipment for direct cardiac application. (See page 2-4 for the relevant symbols used on the modules.) The modules have floating inputs and are protected against the effects of defibrillation and electrosurgery. If the correct electrodes are used and applied in accordance with the manufacturer’s instructions, the screen display will recover within 10 seconds of defibrillation. Type CF equipment is designed to have special protection against electric shocks (particularly regarding leakage current) and is defibrillator-proof.

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Chapter 2 WARNINGS AND PRECAUTIONS The Elios2 bedside monitor is designed to comply with international safety requirements for medical electric equipment, and AAMI voluntary performance standards for cardiac monitors. WARNING!!!:

Do not use the unit in an atmosphere with flammable anesthetic mixtures.

The system is designed to have special protection against electric shocks and is defibrillator-proof. WARNING!!!:

Do not touch the patient, bed or instrument during defibrillation.

Minimizing Electrosurgical Interference How Electrosurgery Interference Affects Patient Monitoring An electrosurgery (ES) device uses voltages which may interfere with the monitored ECG. Radio Frequency (RF) voltages ranging from hundreds to thousands of volts generated by these ES devices are present at the active electrode and are transferred directly to the patient’s body during electrosurgery. This produces ES interference in one, or both, of two possible modes. The most important is “conduction”, in which case the RF signal is carried on and through the patient’s body. The other, “radiation”, occurs when RF noise is transmitted through the air and induced in the monitoring devices and their cables. Suppose that an ES device is set so that the voltage at the active electrode in 100 volts (approximately the minimum setting). Assuming a reduction (attenuation) of the signal by 100,000 times through the body’s natural impedance and by electrical filtering, the ES signal at the ECG lead connection would still be 1 millivolt - just equal to the magnitude to the ECG signal. Complicating the situation is the fact that some electrosurgery devices are designed to superimpose other signals on the RF to generate different cutting or coagulating effects.

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These superimposed signals are often at the same frequencies as ECG components, making it difficult to separate the unwanted interference from the ECG signal with electronic filters. Good monitoring techniques, however, may be used to enhance the quality of the signal, reducing the burden on the filtering.

Conduction The electrosurgery RF signal flows through the patient from the active electrode to the return plate. If the return plate is directly opposite the active electrode, most, but not all, of the energy goes directly to the return plate. The stray ES voltage spreads out over and through the body, becoming smaller as it moves away from the active electrode. Sites farther from the active electrode have smaller RF signals than those which are close. Another aspect of interference is caused by the way in which this RF electrosurgical signal spreads away from the active electrode. Because the spread of the signal is basically symmetrical, two sites equidistant from the active electrode will receive basically the same signal, or will be at basically the same RF voltage. Elios2 amplifiers measure the difference in voltage between their positive and negative inputs. If the ECG electrodes are placed at equal distances from the active electrode, they will have equal RF voltages. With no voltage difference between the positive and negative inputs, the ECG amplifier will have no RF voltage difference to measure and, therefore, no interference. In actual practice, it is probably impossible to place the electrodes exactly equidistant from the active ES electrode. The effort in attempting to do so, however, is well spent, as it tends to minimize the magnitude of “difference mode” interference. In summary, conduction interference can be minimized by: 1. Using the lowest possible ES power setting. 2. Placing the return plate directly under the surgical site. 3. Placing the ECG electrodes as far from the ES site as possible. 4. Placing the ECG electrodes equally distant from the ES site. 5. Placing the ECG electrodes on the frontal or all on the posterior surface.

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Warnings and Precautions

Radiation Radio frequency (RF) voltage always generates an electromagnetic. The intensity of the radiated field, at any point in space, is directly proportional to the source’s voltage and inversely proportional to the distance from the source. In the case of electrosurgery, the active electrode, return plate, and their cables act as transmitting antennas. Electromagnetic fields radiate perpendicular to their associated cables. Therefore, susceptibility of the ECG cable to this RF is maximum when the ECG cable is parallel to the ES cable. Separating or placing cables perpendicular to one another will minimize radiation coupling effects. In summary, radiation interference can be minimized by: 1. Using the lowest possible ES power setting. 2. Keeping ECG cables as far from ES cables as possible. 3. Keeping ECG cables at right angles to ES cables.

Explosion Hazard This device is not intended for use in the presence of flammable anesthetic agents.

Connection of Other Medical Devices Connection of other medical devices to the Elios2, unless specifically recommended by KONTRON MEDICAL, may compromise the performance and/ or patient safety of the unit. When in doubt, contact the company for specific compatibility data.

Use of Manual The instructions for use presented in this manual should in no way supersede established medical protocol concerning patient care.

Responsibility of Manufacturer KONTRON MEDICAL considers itself responsible for the effects on safety, reliability, and performance of the equipment only if: • •

Repairs are carried out by authorized KONTRON MEDICAL personnel only. Electrical installation of the relevant room complies with the appropriate requirements.

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The equipment is used in accordance with instructions for use.

Labeling Symbols The following is a short description of the meaning of the various symbols which appear on the Elios2 and their location on the equipment. Symbol

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Description

Location of Symbol

Alternating Current

Rear of the Processing unit, Isolation Transformer, and Module Rack

Equipotential

On the rear of the Processing unit

Attention, consult accompanying documents (Service to be performed by qualified technician, consult service manual before removing cover)

On Isolation Transformer and Processing unit.

Off (power disconnection from main power supply)

On right of Processing unit

On (power connection to the main power supply)

On the right of the Processing unit.

Type BF applied part defibrillator-proof

On NIBP and Sp02 modules.

Type CF applied part - direct cardiac application defibrillator-proof

On ECG, and Dual BP and CO/2 TMP modules

Fuse

On rear of Processing unit and Isolation Transformer

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Warnings and Precautions

Identification Label The Identification label is located on the Processing unit and the Isolation Transformer.

KONTRON MEDICAL 200-230 50/60

Elios 2 554-000-000 B0288

z Warning: Avertissement: Achtung:

0459

OCTOBER, 1998

Figure 2-1: The Indentification Label The label includes warnings and compliance information as follows: •

Identification information: Part Number (P/N), Serial Number (S/N), and model name

•

Electrical power information: Voltage, Current, and Frequency

•

Warnings: Disconnect supply before servicing, replace fuse as marked

Warning and Compliance Labels The following warning labels appear on the Elios2: •

Isolation Transformer: 1.

•

Caution electrical shock hazard. Do not remove the cover.

Monitor: 1.

Complies with DHHS radiation performance standards, 21 CFR subchapter J

2.

Complies with Part 15 of FCC rules

3.

Place of manufacture

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Electrode and Transducer Protection The Electrodes and Blood Pressure Transducers recommended for use with the equipment and the equipment itself are provided with protective means against burns to the patient when used with high frequency surgical equipment. Immunity requirements of IEC Collateral Standard 60601-1-2 for Electromagnetic Compatibility are met with the transducers recommended for use with the unit (see Appendix A).

General Use of Accessories

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•

Use only KONTRON MEDICAL approved accessories with the Elios2. This includes, but is not limited to, those accessories approved for use with the Vital Signs Modules: ECG, BP/CO/Temp, NIBP, SpO2, and EtCO2.

•

Do not use a damaged accessory. Always refer to the instructions for use included with each accessory.

•

A disposable (single patient) accessory should not be sterilized or cleaned for reuse.

•

Use care when installing accessories such as adapters and cables. Do not use force. Do not cause tension in cables when connecting them to the vital signs modules.

KONTRON MEDICAL

Chapter 3 SYSTEM DESCRIPTION Overview The Elios2 bedside monitor is a modular standalone bedside unit consisting of a main processing unit, a mountable color monitor, and a module rack housing the various KONTRON MEDICAL plug-in modules. The modules monitor the patient’s vital signs. Up to six internal and two external modules can be plugged into each module rack. The vital sign data derived from the modules by the Elios2 are presented on the monitor as waveform and numeric displays. The Elios2’s user interface is especially designed for user-friendly operation. The fixed buttons and unique QuicKnob control on the front panel of the main processing unit enables quick and direct access to system parameters and functions.

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Monitor (Main Screen Display)

Main Screen Key Escape Key Front Panel QuicKnob Fixed Keys Modules

Module Rack

Figure 3-1: The Elios2 Bedside Monitor

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System Description

System Features and Capabilities The Elios2 displays a wide range of vital sign clinical parameters derived from KONTRON MEDICAL modules. These modules include: •

ECG/Respiration multi-lead module for monitoring ECG and respiration.

•

Dual BP & CO/2TMP module for monitoring two invasive blood pressures and either Thermodilution cardiac output or two temperatures.

•

Dual BP for monitoring two invasive blood pressures.

•

Dual Temp for monitoring two temperatures.

•

NIBP module for monitoring non-invasive blood pressure using the oscillometric method.

•

Pulse Oximetry (SpO2) module for monitoring SpO2.

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End Tidal CO2 (etCO2) module for monitoring CO2 during exhalation (etCO2) and inhalation (inCO2).

•

Universal Interface Module (UIM), either Uniport or Multiport, for communication and interface with an external, auxiliary device.

The Elios2’s main monitoring features include: •

Continuously updated vital sign parameter data displayed as numeric values and continuous waveforms.

•

Flexible parameter configuration for each Elios2 provided by the easily transferable plug-in modules.

•

Clinical and technical alarm detection as well as alarm notification in audio and visual formats.

•

Easy access to collected data in the form of tabular charts and graphical trends as well as various types of clinical reports.

•

Patient data output to a recorder or a printer, if connected.

You can interact with the Elios2: •

Using interactive panels These panels include menus and dialog panels that enable you to configure system and monitoring parameters.

•

Responding to Events Fixed keys on the front panel of the main processing unit enable you to respond quickly to events such as alarms.

•

Reviewing Clinical Data

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System Description

Elios2 Operating Manual

Charts, Trends, Full Disclosure and Overview enable you to view and compare data in different formats and over selected time periods.

Monitor and Main Processing Unit The Elios2 can display up to eight traces, depending on how the vital sign display is configured. For monitor control procedures, refer to the User’s Manual. All clinical data collected from the modules are stored in the main processing unit. This data includes waveforms, vital signs, trends, charts and beat-to-beat data. The main processing unit can store at least 36 hours of patient data for review purposes. The front panel of the main processing unit contains 12 fixed keys and the Quicknob. These features enable you to interact with the system. The back panel contains connectors to connect the main processing unit to other components in the system (the display monitor and the module rack) and to the power supply. For a detailed description of the functions and controls of the main processing unit, see “Main Screen Display Features” on page 6-2.

Monitor (main screen display)

Main Processing Unit

Figure 3-2: The Elios2 Display Monitor and Main Processing Unit

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Elios2 Operating Manual

System Description

Display Features

Figure 3-3: The Elios2 Main Screen Display The main screen display is divided into four areas: •

Global Header Area

•

Patient Area

•

Patient Display Area

•

QuicKeys

For a description of all monitor display features and functions, see “Main Screen Display Features” on page 6-2.

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System Description

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Modules The Vital Signs modules are housed in the module rack. They include: •

Multi Lead ECG/RSP

•

Dual BP and CO/2TMP

•

Dual BP

•

Dual Temp

•

NIBP

•

SpO2

•

EtCO2

•

UIM

The module rack acts as the communication link between the modules and the main processing unit. It transfers all messages and continuous data from the modules to the main processing unit.

Figure 3-4: The Elios2 Module Rack with Modules For a detailed description of the module rack, see “Module Rack” on page 6-13.

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Elios2 Operating Manual

System Description

System Specifications General

• • • • •

CPU Details

• • • • •

Intel X86 family main CPU Sound Blaster, 4W audio power Mass storage: 2GB fixed disk, optional expansion available Operating system: QNX Window manager: Photon

User Controls

• •

Fixed Keys QuicKnob™

CPU Dimensions (not including CRT)

• • • •

Height: Width: Depth: Weight:

Power Requirements (not including CRT)

• • •

120 VAC, 2 A, 60 Hz (factory set) 230 VAC, 1 A, 50 Hz (factory set) Fuse rating 3.15 A

Network

•

Physical: IEEE 802.3 Ethernet interface with Category 5, 10BaseT and 100BaseT twisted pair media. Other media available. Protocol: TCP/IP

•

KONTRON MEDICAL

Component-style monitor with Modular Front End CPU with user controls 15, 17, or 20” CRT Module rack and Modules Class I Equipment (Enclosure Grounded) Ordinary equipment continuous operation Applied Part Type BF for: NIBP, SPO2, etCO2 - Defibrillation-proof Applied Part Type CF for: ECG, BP, CO/2 - Defibrillation-proof

9.0 cm/3.625 in 33.0 cm/13.0 in 37.0 cm/14.5 in 8 kg/17.6 lb

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System Description

Color Display

Elios2 Operating Manual

•

• Vital Signs Modules

•

•

Multi Lead ECG/RSP Module

ECG

Single Module: - Height: 10.0 cm (4.0 in) - Width: 4.0 cm (1.6 in) - Depth: 14.0 cm (5.5 in) Double Module: - Height: 10.0 cm (4.0 in) - Width: 8.0 cm (3.2 in) - Depth: 14.0 cm (5.5 in)

• • •

Multi-lead ECG module Includes respiration monitoring and O.R. filter LED for function indication

•

Sampling Rate and Resolution - 640Hz sampling rate - 22 bit resolution Frequency Response - 0.05 to 150 Hz - 0.5 to 40 Hz - 1.0 to 25 Hz QRS Detection Range - 0.25 to 5.0 millivolt height - 70 to 120 milliseconds width Heart Rate Counting - 20 to 300 BPM - Accuracy: ± 2 BPM Note: Values below 20 are forced to zero. Heart Rate Alarm Settings - High and low rate: 20 - 250 BPM non-overlapping

•

•

•

•

3-8

Size: 17” (15”and 20” optional); 15” and 18” Flat TFT display. Traces: 1 to 8, depending on parameter-specific setup choices Resolution: 1024 x 768

KONTRON MEDICAL

Elios2 Operating Manual

System Description

•

•

Respiration

• • • • •

KONTRON MEDICAL

Leads analyzed for: - Heart Rate and Arrhythmia Configuration •Top two displayed •Fixed: I, II, III, Va - Common Mode Rejection •120 dB, minimum - Lead Fault Detection: based on impedence - Pacemaker Detection and Rejection •Amplitude: 2 mV to 700 mV •Width: 0.1 ms to 2.0 ms •Pacemaker flag inserted into displayed waveform •Pacemaker pulse rejection present for Neonatal Data Storage - Patient identification - Parameter settings - Cycle time and measurement time markers - All measurements for 36 hrs. - S/D/M and pulse rate values - Alarm event markers Lead Selection - RA-LA or RA-LL Respiration Sensitivity Range - 0.2 oHm to 5.0 oHm Impedance Range - 100 to 3,000 oHm @ 100 kHz Respiration Rate Counting Range - 8 to 150 BPM Respiration Frequency Response - 0.13 to 2.5 Hz (-3 dB) - Sampling rate: 38 Hz

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System Description

Elios2 Operating Manual

•

•

Dual BP and CO/2 TMP Module

Blood Pressure

3-10

Respiration Alarm Settings - Low rate: 0 - 150 BPM - High rate: 8 - 150 BPM - Apnea: User configurable duration and reset - Cardiac coincidence alarm Data Storage (in mainframe): - Patient identification - Waveform labels and annotations - Instantaneous resp. rate - Alarm event markers

• • • •

Single module size 2 invasive blood pressures Thermodilution Cardiac Output, or 2 temperatures LED for function indication

•

Site Labels: - BPX, ART, PAP, CVP, RAP, LAP, ICP

•

Input Sensitivity 5 microVolt/mmHg

•

Dynamic Range - Pressure range: -50 to +300 mmHg - Zero range: ±150 mmHg - Total dynamic range: -200 to +450 mmHg

•

Transducer Excitation Voltage - +7.5 VDC - Separate excitation driver for each channel

•

Zero Accuracy - ±0.2 mmHg

•

Zero Drift - Less than ±0.2 mmHg in 24 hours (at constant temperature)

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Elios2 Operating Manual

Cardiac Output and Temperature

KONTRON MEDICAL

System Description

•

Blood Pressure Accuracy - ±2 mmHg or ±2%, whichever is greater, exclusive of transducer

•

Blood Pressure Linearity - within 1% across entire range

•

Waveform Frequency Response - 0 - 15 Hz

•

Sampling Rate - 320 Hz

•

Fault Detection - Shorted transducer - Transducer in/out - cable out

•

Data Storage (in mainframe): - Patient identification - Beat labels and annotations - Beat to beat S/D/M values - Alarm event markers

•

Adapter and Compatability Cables - COSet™ Interface cable - Ice Bath Cardiac Output interface cable - Dual temperature interface cable (ysi-400)

•

Temperature Ranges - Blood temperature: 27 degrees C to 45 C - Injectate temperature: 0 degrees C to 25 C - Body temperature: 0 degrees C to 43 C

•

Accuracy - Blood temperature: ±0.1°C - Injectate temperature: ±0.1°C

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System Description

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Elios2 Operating Manual

•

Excitation - 10µA, maximum

•

Cardiac Output Determination Range - 0 to 20 liters per minute

•

Injectate Volumes - 1, 3, 5, and 10cc

•

Computation Constants - Table built as new values are used

•

Displayed Data - Cardiac Output, Cardiac Index, Stroke Volume, Stroke Volume Index, Blood Temperature, Injectate Temperature, Trial Number

•

Data Storage (in mainframe): - Patient identification - Parameter settings - Waveform segments used in procedures - Hemodynamics procedure results - Temperature trends, 1 min. resolution

Dual BP

• • •

Single module size 2 invasive blood pressures LED for function indication

Dual Temp

• • •

Single module size 2 temperatures LED for function indication

KONTRON MEDICAL

Elios2 Operating Manual

Non-Invasive Blood Pressure Module

System Description

• •

Double module size LED for function indication

•

Oscillometric Method

•

Displayed Parameters - Systolic, Diastolic, Mean pressure values - Time of last measurement, measurement interval, cuff size, and heart rate

•

Cuff Size - Adult, Pediatric, Infant, Neonatal

•

Inflation Rate - within 5 sec. - initial inflation target: 150 mmHg, Adult/Pediatric - initial inflation target: 70 mmHg, Neonatal

•

Cuff Pressure Limits - Adult/Pediatric - Automatic Over Pressure Limit: 280 mmHg - Redundant: 300 mmHg Cuff Pressure Limits - Neonatal - Automatic Over Pressure Limit: 158 mmHg - Switch Operating Limit: 165 mmHg

•

KONTRON MEDICAL

•

Cycle Times - Deflation time (typical): 30 sec - BP time-out: 60 - 180 sec.

•

Determination Time (excluding cuff pressure time) - 18 seconds typical; 60/[email protected] BPM

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System Description

Elios2 Operating Manual

•

•

Pulse Oximetry (Sp02) Module

3-14

Measurement Ranges (in mmHg) Adult/Pediatric - Systolic: 25-265 - Diastolic: 12-220 - Mean: 18-245 Measurement Ranges (in mmHg) Neonatal - Systolic: 25-155 - Diastolic: 12-110 - Mean: 18-130

•

Modes: Adult, Auto, Manual, STAT, SelfTest, Neonatal

•

Pressure (Transducer) Accuracy - ±3 mmHg or ±2%, whichever is greater

•

Heart Rate - 40-140 BPM Adult/Pediatric - 40-240 BPM Neonatal

•

Data Storage (in mainframe): - Patient identification - Parameter settings - Measurement modes - Beat labels and annotations - Cycle time and measurement time markers - S/D/M and HR values - Alarm event markers

•

Single module size (Nellcor Technology - MP204P)

•

Saturation Range - 1% to 100% Sp02

•

Sp02 Accuracy - % SpO2 ± 1 standard deviation

•

Pulse Rate Range - 20 to 250 BPM ±3 BPM

KONTRON MEDICAL

Elios2 Operating Manual

End Tidal CO2 (etCO2) Module

KONTRON MEDICAL

System Description

•

Low saturation alarm limits: 70% to 100%

•

Data Storage (in mainframe): - Patient identification - Waveform labels and annotations - Heart rate and O2 saturation - Alarm event markers

• • •

Double module size LED for function indication Air outlet for sidestream monitoring

•

Displayed Data - Waveform labels and annotations - etCO2, inCO2 and respiration rate values

•

CO Display Range: 0-100 mmHg

•

Measurement Accuracy: - ±2 mmHg for 0-40 mmHg - ±5 mmHg for 41-76 mmHg - ±10 mmHg for 77-100 mmHg

•

Stability: <1% outside specifications after 12 months

•

Rise Time (Sidestream): 240 msec (10% - 90%)

•

CO2 Alarm Limits: 0 to 100 mmHg/0 - 10%/0-15 kPA

•

Accuracy: - for % measurement: 0.1% - for mmHg measurement: 1mm

•

Respiration Rate Alarm Limits: - Neonatal: 0 to 150 BMP - Adult: 0-50 BPM

•

Sidestream Flow Rate: 130 mml/min

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System Description

UIM - Uniport or Multiport (3 ports)

Elios2 Operating Manual

•

Start-up Time: - <30 sec typical in sidestream - <80 sec in Mainstream mode @ 25° C

•

Pressure Compensation: continuous and automatic in mainstream and sidestream mode

•

Ambient Temperature: - 5-40° C Sidestream - 10-40° C Mainstream

•

Humidity: 15-95% RH, non-condensing

•

Barometric Pressure: 428-790 Hg (1150 - 15,000 ft.)

•

Data Storage (in mainframe): - Patient identification - Waveform labels and annotations - etCO2, inCO2 and respiration rate values - Alarm event markers

• •

Single module size Serial data interface for asynchronous communication with an external monitor or other device Database of interface codes for up to 31 external devices Displays vital signs and waveform data of external device/s Displays alarms of the external device/s Cable In/Out detection Led for function indication

• • • • • Clinical Software Features

3-16

•

Waveform Display - 175mm horizontal area - 7 sec. @ 25mm/sec - Up to 8 traces - Overlapping traces - Expanded display

KONTRON MEDICAL

Elios2 Operating Manual

System Description

Numeric Display

• • • •

85mm horizontal area 25mm Heart Rate 20mm Sp02 “Big Numbers”

Default Alarms

• •

User defined Fixed or calculated values

Data Display

• •

Tabular charts Graphic trends

Environmental

• • • •

Ambient Temperature: 5° C to 40° C Humidity: 10-95%, non-condensing Altitude: -400 to 3050 meters (-1300 to 10,000 ft.) Storage:

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Chapter 4 INSTALLATION AND SETUP Unpacking and Inspection Before unpacking the Elios2 bedside monitor, the packaging should be visually inspected for any signs of damage or abuse which may have resulted during shipment. If any signs of external damage are visible, you should contact your nearest KONTRON MEDICAL agent before proceeding to unpack the unit. Failure to do so could invalidate the warranty. During unpacking, each item should be unpacked carefully and should be visually inspected for any signs of damage which may have resulted during shipment. All components should be checked against the packing list to confirm their availability. Should any damage be apparent or any part found missing, contact your KONTRON MEDICAL agent immediately. Do not attempt to set up the system if any damage to a component is apparent.

Setting Up the System The Elios2 consists of three parts: the Display Monitor, the Computer Processor Unit, and the Vital Signs Module Rack. These should be set up according to system description. Care should be taken when handling the components. The display monitor can be placed either on top of the processor unit or on a wall mount. A variety of different types of wall mounts can be used. Select the wall mount according to your hospital’s individual requirements. Wall mounts obtained from KONTRON MEDICAL are supplied with detailed instructions.

Installation Procedures Proper installation of the Elios2 is divided into three phases: Site survey, physically mounting the monitor and cable interconnection. If your hospital has special installation requirements, these may call for special planning and materials that must be furnished by your hospital and are not covered by this manual.

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Installation and setup

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Site Survey Performing a site survey ensures that all environmental, electrical, and cabling requirements are taken into consideration. This ensures that the actual installation proceeds as smoothly as possible and that the installed equipment will run reliably. A site survey should be performed every time an Elios2 bedside monitor is installed. The hospital Biomedical Engineer and Facilities Engineer should participate in any discussion which must include: •

Reviewing details and drawings of hospital layout and architecture.

•

Planning of all cable ducts, raceways, runs, wall plates, pull boxes and other interconnection details.

•

Establishing length of cable runs.

•

Reviewing AC power requirements, locations and types of outlets.

•

Discussing the type of emergency (backup) AC power supply to be used, time of transfer (periodic test), degree of transient introduced into the power line (how long is power interrupted?), frequency and voltage of emergency power.

•

Reviewing environmental considerations, such as ambient temperature, humidity control, potential static charge, and expected tolerances in the area planned for the Elios2.

Measure AC power disturbances over a period of at least 24 hours with a power line analyzer. It is important to perform this test over the period of emergency power transfer to measure the severity of transients during the transfer.

Environmental Requirements The location selected for the Elios2 should be out of direct sunlight and in a clean-air atmosphere. Avoid dusty areas or areas where there are airborne dirt particles. Avoid static build-up and discharge which may result in disruptions of operation and loss of data. Reasonable environmental parameters are: •

Temperature: 10° to 32° C (50° to 90° F)

•

Relative Humidity: 30% to 95% (non-condensing)

Wall Mounting Instructions To properly mount your Elios2 bedside monitor, refer to the wall mounting instructions supplied with your wall mounting kit. It is the responsibility of the hospital, its consultants, and/or contractors to determine that the wall is adequate to safely mount instrumentation. This includes the selection of appropriate fasteners and the proper installation of the same.

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Elios2 Operating Manual

Installation and setup

Cable Interconnection Connect the monitor and the module rack to the main processing unit according to Figure 4-1: To connect the monitor to the main processor: 1.

Use a video AC power cord to connect between the AC inlet on the monitor and the monitor AC outlet (female) on the main processing unit.

2.

Connect the data display cable between the RGB input on the monitor and the video input on the main processing unit.

To connect the module rack to the main processor: •

Use the module data cable to connect between the data outlet on the side of the module rack to the data inlet on the main processing unit.

To connect the main processing unit to the power supply: •

Connect the power cable to a hospital-grade power outlet.

Grounding the System To protect the patient and hospital personnel, the Elios2 system must be grounded. Accordingly, the system is equipped with a detachable 3–wire cable which grounds the instrument to the power line ground (protective earth) when plugged into an appropriate 3–wire receptacle. If a 3–wire receptacle is not available, consult the hospital electrician. WARNING!!!:

Do not use a 3–wire to 2–wire adapter with this instrument.

If the processor and the display module are set up together, connect the grounded wire to the equipotential grounding terminal on the display. If the processor and the display module are separated, connect the grounding wire to the display as well as to the processor. WARNING!!!:

If it is not evident from the instrument specifications whether a particular instrument combination is hazardous or not, for example due to summation of leakage currents, the user should consult the manufacturers concerned or an expert in the field to ensure that the necessary safety of all instruments concerned will not be impaired by the combination.

Note: The module data cable includes a grounding shield which automatically

provides grounding protection between the module rack and the main processing unit.

KONTRON MEDICAL

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Installation and setup

Elios2 Operating Manual

Figure 4-1: Elios2 Cable Interconnection

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Elios2 Operating Manual

Installation and setup

Equipotential Grounding Protection class 1 instruments are already included in the protective grounding (protective earth) system of the room by way of grounding contacts in the power plug. For internal examination on the heart or the brain, the Elios2 must have a separate connection to the equipotential grounding system. One end of the equipotential grounding cable (potential equalization conductor) is connected to the equipotential grounding terminal on the instrument’s rear panel and the other end to one point of the equipotential grounding system. The equipotential grounding system assumes the safety function of the protective grounding conductor if ever there is a break in the protective grounding system. Examinations in or on the heart (or brain) should only be carried out in medically used rooms incorporating an equipotential grounding system. Check each time before use that the instrument is in perfect working order. The cable connecting the patient to the instrument must be dry and clean. CAUTION!

When performing examinations in or on the heart (or brain), the conductive parts of electrodes and associated connectors, including the neutral electrode, should not contact other conductive parts including earth.

Electrosurgery, Diathermy and Defibrillation Protection Neither electrosurgery and diathermy instruments nor defibrillation will damage the monitor. If the correct electrodes are used and applied according to the manufacturer’s instructions, the screen display will recover within 10 seconds of defibrillation. The modules have floating inputs are defibrillator-proof. For most efficient monitoring when electrosurgery is in use, see “Minimizing Electrosurgical Interference” in “Warnings and Precautions”. WARNING!!!:

DO NOT TOUCH THE PATIENT, BED OR INSTRUMENT DURING DEFIBRILLATION.

Accidental Wetting of the Equipment If, for whatever reason, the equipment accidentally gets wet, remove all patient connections and turn the unit off. Thoroughly wipe all wet areas and then allow sufficient time to ensure that the equipment is completely dry before proceeding.

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Patient Connections All patient connections on the Elios2 Vital Signs modules have special keys to prevent user error. The rear panels of the Processor, Display module and Module rack have no patient connections.

CAUTION!

Recommended Setup for Neonatal Applications KONTRON MEDICAL recommends the following setup for Neonatal. Setup for Neonatal should be entered via the System Setup. This should be performed by the System Administrator or requested as a Factory Setup.

Table 1: Recommended Setup Parameters Module

Low Alarm

High Alarm

Display

ECG

100

200

Waveform - 1 lead

Respiration

30

100

Waveform

Apnea

20 sec

NIBP Sys/Dia/M

50/20/20 mmHg

90/60/70

Big Numbers

BP-Art Sys/Dia/M

50/20/30 mmHg

90/60/70

Wavefrom - option

BP-PAP Sys/Dia/M

24/-4/12 mmHg

60/4/26

Waveform -option

BP-CVP Mean

2

10

BP-ICP Mean

2

10

SpO2

80%

95%

EtCO2

35 mmHg

45 mmHg

Temperature

36.0 C (96.8 F)

39.0 C (102.2 F)

Big Numbers - T1

TcpO2 / TcpCO2

60/35 mmHg

90/45 mmHg

Big Numbers - Opt

Recommended Display Options for CRG

In Respiration

Waveform -option Waveform -option Waveform -option Waveform -option

CRG1 = HRT, Resp CRG 2 = SpO2, BP

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Elios2 Operating Manual

Installation and setup

Note: Optimal parameters will be included in Neonatal Admit key only if they

areincluded in Neonatal Admit key only if they are included inthe prucchased monitor configuration. Height: Select cm or inch Weight: Select gram or ounce

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Chapter 5 MAINTENANCE AND CLEANING Cleaning the Elios2 Bedside Monitor The Elios2 bedside monitor can be cleaned with most common hospital cleaning solutions and detergents. Be careful not to use caustic detergents or ammonia or acetone-based cleaning solutions. These may damage the bedside monitor. Â

To clean the Elios2 bedside monitor and accessories: 1.

Switch the monitor off and disconnect from the power supply before cleaning.

2.

Dust the monitor regularly. Clean with a lint-free cloth or sponge dampened with cleaning solution. Abrasive scouring powders and pads should be avoided to prevent damage to the monitor.

3.

Clean the display screen with non-abrasive glass cleaners, such as “Ajax” or “Windex”. Use a lint-free cloth. A paper towel may damage the screen.

4.

Clean patient cables and all exposed surfaces with mild soap solution only. Using alcohol or any type of concentrated cleaning solution may impair patient cable flexibility.

5.

Remove any adhesive used to attach the cable to the patient. To remove adhesive residue, use a plaster remover solution made up of one-third alcohol, twothirds water, or use a commercial tape remover such as Scholl Double Seal tape remover. Do not use strong solvents (acetone, straight alcohol, ammonia, etc.). These will damage the cable.

6.

Do not autoclave patient leads, transducer components or other sensors. Autoclaving permanently damages these instruments. If you need to sterilize accessories, we recommend Et0 gas sterilization.

KONTRON MEDICAL

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