VITALOGIK Configured Patient Monitor User Manual 641-OPT-114 December 2006

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices Manufacturer’s Name: Mennen Medical Ltd. 4 Hayarden Street, Yavne, 81228 P.O. Box 102, Rehovot, 76100, Israel Tel.: +972-8-9323333 Fax: +972-8-9328510 European Representative: Charter-Kontron Limited Unit 18 Avant Business Centre 21 Denbigh Road Milton Keynes MK1 1DT England Tel.: 01908 646070 Fax: 01908 646030 US Representative: Mennen Medical Corp 101 Witmer Road Suite100 Horsham, PA 19044 Phone: 215-259-1020X1026 Fax: 215-675-6212

Toll Free: 800-223-2201

Publication No.641-OPT-114 Ver. 3.8b Revision: December 2006 Copyright © Mennen Medical Mennen Medical Ltd. 2006. All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders.

TABLE OF CONTENTS 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 Explosion Hazard... 2-3 Connection of Other Medical Devices... 2-3 Use of Manual... 2-3 Responsibility of Manufacturer... 2-3 Labeling... 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... 3-2 System Specifications... 3-5 Chapter 4: Installation and setup Unpacking and Inspection... 4-1 Setting Up the System... 4-1 Installation Procedures... 4-1 Chapter 5: Maintenance and Cleaning Cleaning the VitaLogik Bedside Monitor... 5-1 Calibration and Preventive Maintenance... 5-2

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Chapter 6: Controls and Functions Power On... 6-1 AC Operation... 6-2 Power Interruptions... 6-2 Main Screen Display Features... 6-3 Main Processing Unit... 6-8 Working With Menus and Panels... 6-15 Section 2 Patient Monitoring Procedures Chapter 7: Alarms General Features... 7-1 Alarm Notification... 7-1 Alarm Priority... 7-3 Setting Up Alarms... 7-5 Alarm Controls... 7-5 Multi-Parameter Alarms... 7-7 Alarm Status... 7-7 What To Do When an Alarm Occurs... 7-9 Alarm Messages... 7-10 Chapter 8: Setting Up the Patient Display Display Controls... 8-2 Cardio Respiratory Graph (CRG)... 8-5 Remote View... 8-9 Chapter 9: Connecting a Patient to the VitaLogik Patient Preparation... 9-1 Admission, Discharge and Transfer Procedures... 9-1 Setting up Monitoring Profiles... 9-17 Chapter 10: Reviewing Patient Data Trends... 10-1 ST Watch... 10-3 Charts... 10-10 Full Disclosure... 10-13 Overview... 10-19 Event Strips... 10-21 Reports... 10-25

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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 Recording Types... 13-5 Section 3 VITAL SIGNS MONITORING Chapter 14: ECG Overview... 14-1 ECG LED Indicator... 14-1 Patient Preparation... 14-2 ECG Monitoring Checklist... 14-5 ECG Monitoring Procedures... 14-5 Setting ECG Leads & Gain Parameters... 14-7 Setting ECG Alarms... 14-10 Setting ECG Display Options... 14-14 Setting QRS Tone Volume... 14-15 Detecting a Pacemaker... 14-17 Pacer Alarms... 14-19 Setting the Heart Rate Source... 14-20 Selecting a Filter... 14-21 Chapter 15: Arrhythmia Monitoring Procedures... 15-3 Accessing the Arrhythmia Menu... 15-4

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Activating and Setting Alarms... 15-4 Activating Arrhythmia Monitoring... 15-8 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 Chapter 17: Respiration Overview... 17-1 Patient Preparation... 17-1 Monitoring Procedures... 17-2 Setting Respiration Leads and Gain... 17-3 Setting Respiration Alarms... 17-4 Setting Resp Display Options... 17-7 Setting the Heart Rate Coincidence Alarm... 17-9 Activating and Deactivating Respiration Monitoring... 17-11 Chapter 18: Invasive Blood Pressures (BP) Overview... 18-1 Warnings... 18-2 Preparatory Checklist... 18-3 BP Monitoring Procedures... 18-3 Accessing the BP Menu... 18-4 Zeroing BP Transducers... 18-4 Selecting the BP Scale... 18-6 Setting BP Alarms... 18-7 Setting BP Display Options... 18-11 Deriving the PCWP Value... 18-13 Measuring the Central Venous Pressure... 18-14 Activating and Deactivating BP Monitoring... 18-16 Chapter 19: Cardiac Output (C.O.) Overview... 19-1 Preparatory Checklist... 19-2 Measuring Procedures... 19-2 Cardiac Output Measurement... 19-5 Cardiac Output Fick Method... 19-10 Chapter 20: Temperature Overview... 20-1 Preparatory Checklist... 20-1

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Temperature Monitoring Procedures... 20-2 Setting Temperature Alarms... 20-3 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 Limitations of the Oscillometric Method... 21-2 Preparatory Checklist... 21-3 Warnings... 21-3 Monitoring Procedures... 21-4 Accessing the NIBP Menu... 21-5 Setting Reading Intervals... 21-5 Selecting the Cuff Type... 21-8 Setting NIBP Alarms... 21-9 Setting NIBP Display Options... 21-12 Activating NIBP Measuring and Monitoring... 21-13 Technical Messages... 21-14 Chapter 22: Pulse Oximetry (Sp02) Overview... 22-1 Patient Preparation Checklist... 22-2 Monitoring Procedures... 22-4 Accessing the Sp02 Menu... 22-5 Setting Sp02 Alarms... 22-5 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 Masimo Technology... 22-14 Chapter 23: End Tidal CO2 (EtCO2) Microstream Principles of Operation... 23-1 Intended Use... 23-2 Microstream EtCO2 Circuits... 23-2 Patient Preparation Checklist... 23-3 Cautions and Warnings... 23-4 Interfering Gasses... 23-4 Cleaning... 23-4 Calibration... 23-4 Non-intubating Sidestream Monitoring... 23-5 Intubated Sidestream Monitoring... 23-5

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Monitoring Procedures... 23-5 Accessing the EtCO2 Menu... 23-6 Setting EtCO2 Alarms... 23-6 Setting EtCO2 Display Options... 23-10 Activating EtCO2 Monitoring... 23-12 Points to Consider and Possible Causes of Error... 23-12 Chapter 24: MULTIGAS ANESTHESIA ANALYZER Overview... 24-1 Model 4800 Principle of Operation... 24-1 Intended Use... 24-2 Anesthetic Gas Module... 24-2 Cautions and Warnings... 24-2 Cleaning... 24-3 Calibration... 24-3 Anesthetic Gas Module... 24-5 Patient Connection... 24-5 Alarm Messages... 24-6 Accessories... 24-6 Module Specifications... 24-7 Chapter 25: MULTIGAS ANESTHESIA ANALYZER - IRMA Overview... 25-1 IRMA Principle of Operation... 25-1 Intended Use... 25-2 Connection... 25-2 Pre- use Check... 25-4 Room Air Calibration... 25-4 IRMA LED Status... 25-5 Cautions and Warnings... 25-5 Cleaning... 25-6 Preventive Maintenance... 25-6 Alarm Messages... 25-8 Specifications... 25-9 Chapter 26: Anesthetic Gas Monitoring Overview... 26-1 Monitoring Procedures... 26-1 EtCO2 Monitoring Procedures... 26-1 Accessing the EtCO2 Menu... 26-2 Setting EtCO2 Alarms... 26-3 Setting EtCO2 Display Options... 26-7 Setting the Scale... 26-8

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Activating EtCO2 Monitoring... 26-9 O2, N2O, and Anesthetic Agent Monitoring Procedures... 26-10 Accessing the O2, N2O and Anesthetic Agent Menu... 26-11 Setting O2, N2O and Anesthetic Agent Alarms... 26-12 Setting O2, N2O and Anesthetic Agent Display Options... 26-15 Selecting the O2, N2O and Anesthetic Agent Scale... 26-16 Activating Monitoring... 26-18 MAC (Minimum Alveolar Concentration )... 26-19 ... 26-20 Chapter 27: Ventilator Overview... 27-1 Ventilator Parameters... 27-2 Monitoring Procedures... 27-2 Ventilator Menu... 27-3 Setting Alarms... 27-4 Setting Ventilator Display Options... 27-7 Activating and Deactivating Ventilator Monitoring... 27-10 Alarm Messages... 27-11 Section 4 Appendixes Appendix A: ACCESSORIES Appendix B: Trouble Shooting ECG/Respiration Monitoring... B-1 Invasive Blood Pressure Monitoring... B-2 EtCO2... B-3 Response to Single Lead Fault... B-4 Appendix C: Auto-Set Dynamic Alarm Limits Appendix D: Chapter 5 of Service Manual Introduction... D-2 Date & Time Setup... D-7 General Settings... D-11 Alarm Volume and Controls... D-14 Sound Event... D-17 Default Alarm Limits... D-18 Event Setup... D-20 Vital Sign (VS) Setup... D-22 Parameter Hierarchy... D-53

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Monitor Profiles Setup... D-54 Admit by Default... D-57 Report Setup... D-58 Network Setup... D-64 Recorder Setup... D-65 Trends Setup... D-67 See page 5-78 at the end of this chapter... D-67 Quick Keys Setup... D-67 Tabular Charts... D-68 Software Version... D-72 Parallel Port Setup... D-73 Envoy Interface Setup... D-74 Change Password... D-75 Check Disk... D-76 Permission Editor... D-76 Remove Saved Patients... D-77 Trends Setup... D-78 Touch Screen Calibration... D-79

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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

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

Section 1 introduces the VitaLogik 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.

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Section 3 describes vital sign monitoring procedures performed by the VitaLogik 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 VitaLogik bedside monitor as provided by Mennen Medical. This configuration can be changed according to your hospital’s needs by your Biomedical Engineering department, System Administrator or a Mennen 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 VitaLogik bedside monitor is intended for use as a multi-parameter physiological patient monitoring system. The VitaLogik bedside monitor can monitor ECG/Heart Rate, two invasive blood pressure channels, Cardiac Output, temperature, pulse oximetry, respiration noninvasive blood pressure and End tidal CO2. This effectively allows the VitaLogik

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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 VitaLogik 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

The VitaLogik monitor is supplied in two models: •

VitaLogik 5000 provides the non-invasive vital signs: ECG, NIBP, SpO2, and Temperature with optional EtCO2

•

VitaLogik 5500 has full monitoring capacity and includes: ECG, NIBP, SpO2, Temperature, 2 BP and CO/2 Temp with optional EtCO2

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

Compliance The VitaLogik 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 60601-2-34, IEC 60601-2-30 and AAMI voluntary performance standards for cardiac monitors. European Directive 93/42/EEC classifies the VitaLogik bedside monitor as a Class IIb device. The NIBP and SpO2 are classified as Type BF equipment. The ECG and Dual BP and CO/2 Tmp are classified as Type CF equipment for direct cardiac application. (See page 2-4 for the relevant symbols used on the inputs.) The inputs are 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

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against electric shocks (particularly regarding leakage current) and is defibrillatorproof.

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CHAPTER 2: WARNINGS AND PRECAUTIONS The VitaLogik 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. These superimposed signals are often at the same frequencies as ECG components,

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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. VitaLogik 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:

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Using the lowest possible ES power setting.

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Placing the return plate directly under the surgical site.

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Placing the ECG electrodes as far from the ES site as possible.

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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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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. 2. 3.

Using the lowest possible ES power setting. Keeping ECG cables as far from ES cables as possible. 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 VitaLogik, unless specifically recommended by Mennen Medical, Ltd., 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 Mennen Medical, Ltd. considers itself responsible for the effects on safety, reliability, and performance of the equipment only if: • •

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Repairs are carried out by authorized Mennen 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 VitaLogik and their location on the equipment. Symbol

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Description

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Alternating Current

Alternating Current Rear of the Processing unit and Isolation Transformer.

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.

Type CF applied part - direct cardiac application defibrillator-proof

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

Fuse

On rear of Processing unit and Isolation Transformer.

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