Elios2 Patient Monitor Operating Manual Edition 1 Nov 2011

Revision: July, 2001

TABLE OF CONTENTS Section 1 Introduction Chapter 1 What You Should Know Manual Structure... 1-1 Changes in Default Configuration... 1-1 Intended Use... 1-1 Prescription Notice... 1-2 Compliance... 1-2 Chapter 2 Warnings and Precautions Minimizing Electrosurgical Interference... 2-1 How Electrosurgery Interference Affects Patient Monitoring... 2-1 Conduction... 2-2 Radiation... 2-3 Explosion Hazard... 2-3 Connection of Other Medical Devices... 2-3 Use of Manual... 2-3 Responsibility of Manufacturer... 2-3 Labeling... 2-4 Symbols... 2-4 Electrode and Transducer Protection... 2-6 General Use of Accessories... 2-6 Chapter 3 System Description Overview... 3-1 System Features and Capabilities... 3-3 Monitor and Main Processing Unit... 3-4 Modules... 3-6 System Specifications... 3-7

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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... 8-1 Adjusting Sweep Speed... 8-2 Selecting a Special Display Format... 8-2 Cardio Respiratory Graph (CRG)... 8-3 CRG Display... 8-4 Chapter 9 Connecting a Patient to the Elios2 Patient Preparation... 9-1 Admission, Discharge and Transfer Procedures... 9-1 The ADT Menu... 9-1 Patient Transfer... 9-6

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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... 11-1 Hemodynamics Calculations... 11-3 Respiratory Mechanics Calculations... 11-4 Oxygenation Calculations... 11-5 Renal Clearance Calculations... 11-6 Chapter 12 Performing Medication Calculations Accessing Medications... 12-1 Using The Medication Calculation Panels... 12-2 Infusion Rate Calculation... 12-3 Drug Concentrate Calculation... 12-4 Injection Amount Calculation... 12-6 Chapter 13 Recording Vital Sign Data Waveform Recording... 13-1 IV

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Recorder Status Indication... 13-3 Anatomy of the Recorder Strip... 13-3 Assigning a Chart Recorder to the Elios2... 13-5 Recording Types... 13-5 Manual Recording... 13-5 Vital Sign Alarm Recording... 13-5 Multi-ECG Recording... 13-6 Selective Recording... 13-6 All Waveform Recording... 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... 15-3 Accessing the Arrhythmia Menu... 15-4 Activating and Setting Alarms... 15-4 Activating and Setting Individual Arrhythmia Alarms... 15-6

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Activating Arrrhythmia Monitoring... 15-9 Chapter 16 ST Segment Analysis Monitoring Procedures... 16-2 Accessing the ST Menu... 16-2 Activating ST Monitoring... 16-3 Setting ST Alarms... 16-3 Setting ST Alarm Limits... 16-3 Setting ST Alarm Responses... 16-5 Setting Display Options... 16-6 Manually Determining the ISO an ST Measuring Points... 16-7 Determining ST Variations... 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... 20-1 Preparatory Checklist... 20-1 Temperature Monitoring Procedures... 20-2 Accessing the Temperature Menu... 20-2 Setting Temperature Alarms... 20-3 Setting Temperature Alarm Limits... 20-3 Setting Temperature Alarm Response... 20-5 Setting Temperature Display Options... 20-6 Activating Temperature Monitoring... 20-7 Setting Delta Temperature... 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... 24-1 tcGas Module... 24-1 tcGas Monitoring Procedures... 24-2 Accessing the tcGas Menu... 24-2 Setting tcGas Alarms... 24-3 Setting tcGas Alarm Limits... 24-3 Setting tcGas Alarm Response... 24-5 Setting tcGas Display Options... 24-6 Activating and Deactivating tcGas Monitoring... 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... 26-13 Setting O2, N2O and Anesthetic Agent Alarms... 26-13 Setting O2, N2O and Agent Alarm Limits... 26-13 Setting O2, N2O or Agent Alarm Response... 26-15 Setting O2, N2O and Anesthetic Agent Display Options... 26-17 Selecting the O2, N2O and Anesthetic Agent Scale... 26-19 Activating Monitoring... 26-20 Activating O2 and N2O Monitoring... 26-20 Activating Anesthetic Agent Monitoring... 26-21 Alarm Messages... 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.

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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.

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

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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

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Cardiac stepdown/telemetry units

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Emergency departments

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Intra-operative (anesthesia) monitoring

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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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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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