VITALOGIK 4000 and 4500 User Manual Rev G Nov 2014

Conformity according to the Council Directive 93/42/EEC concerning Medical Devices Manufacturer’s Name : Mennen Medical Ltd. 4 Hayarden Street, Yavne, 8122804 P.O. Box 102, Rehovot, 7610002, 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

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US Representative: Mennen Medical Corp. 290 Andrews Road Feasterville-Trevose, PA 19053-3480 Phone 215 259-1020 Fax 215 357-2010 Publication No. DDM-000-003 Ver. 7.0 Revision G November 2014 Copyright © Mennen Medical Ltd. 2014. All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders.

VitaLogik 4000/6000 Series® Operating Manual

TABLE OF CONTENTS Table of Contents Section 1 Introduction Chapter 1: What You Should Know Training ... 1-1 Service ... 1-1 Prescription Notice ... 1-1 User Capability ... 1-1 VitaLogik 4000/4500 Part Numbers ... 1-2 VitaLogik 6000 Part Numbers ... 1-2 Manual Structure ... 1-4 Changes in Default Configuration ... 1-4 Intended Use ... 1-4 Compliance ... 1-5 Network – Mennen-Net ... 1-6 Chapter 2: Warnings and Precautions Power Failure ... 2-1 Minimizing Electrosurgical Interference ... 2-2 Electrical Shock Hazard ... 2-3 Connection of Other Medical Devices ... 2-3 Explosion Hazard ... 2-4 Environmental Status ... 2-4 Monitor Storage ... 2-4 Use of Manual ... 2-4 Responsibility ... 2-4 Labeling ... 2-5 Electrode and Transducer Protection ... 2-7 General Use of Accessories ... 2-7 Disposal of Monitors and Accessories ... 2-8 Chapter 3: System Description Overview ... 3-1 System Features and Capabilities ... 3-2 System Specifications ... 3-6 Chapter 4: Installation and setup Unpacking and Inspection ... 4-1

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Setting Up the System ... 4-1 Installation Procedures ... 4-1 Chapter 5: Maintenance and Cleaning Cleaning the VitaLogik 4000/6000 Series Bedside Monitor ... 5-1 Calibration and Preventive Maintenance ... 5-2 Battery Conditioning ... 5-2 Equipment End of life ... 5-3 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 ... 6-13

Section 2 Patient Monitoring Procedures Chapter 7: Setting Up the Patient Display Display Controls ... 7-2 Cardio Respiratory Graph (CRG) ... 7-5 Remote View ... 7-9 Chapter 8: Alarms General Features ... 8-1 Alarm Notification ... 8-2 Alarm Priority ... 8-5 Setting Up Alarms ... 8-7 Alarm Controls ... 8-7 Alarm Status ... 8-9 What To Do When an Alarm Occurs ... 8-11 Alarm Messages ... 8-12 Chapter 9: Connecting a Patient to VitaLogik 4000/6000 Series Patient Preparation ... 9-1 Admission, Discharge and Transfer Procedures ... 9-1 Setting up Monitoring Profiles ... 9-21 Chapter 10: Reviewing Patient Data Trends ... 10-2 ST Watch ... 10-5

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Charts ... 10-12 Full Disclosure ... 10-15 Overview Panel ... 10-21 Event Strips ... 10-23 Reports ... 10-27 Heart Rate Variability - HRV ... 10-31 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 Calculation Formulas ... 12-1 Accessing Medications ... 12-3 Using The Medication Calculation Panels ... 12-4 Infusion Rate Calculation ... 12-4 Drug Concentrate Calculation ... 12-6 Injection Amount Calculation ... 12-7 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 Deactivation ... 14-1 QRS Detection ... 14-2 ECG LED Indicator ... 14-2 Patient Preparation ... 14-2 ECG Monitoring Checklist ... 14-6 ECG Monitoring Procedures ... 14-6 Setting ECG Leads & Gain Parameters ... 14-8 Setting ECG Alarms ... 14-12 Setting ECG Report ... 14-16 Setting ECG Display Options ... 14-17 Setting QRS Tone Volume ... 14-18 Detecting a Pacemaker ... 14-20

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Pacer Alarms ... 14-22 Setting the Heart Rate Source ... 14-23 Selecting a Filter ... 14-24 PR / QT Measurement ... 14-26 Chapter 15: Arrhythmia Introduction ... 15-1 Monitoring Procedures ... 15-4 Accessing the Arrhythmia Menu ... 15-4 Activating and Setting Alarms ... 15-5 Activating Arrhythmia 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 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 ... 17-8 Setting the Heart Rate Coincidence Alarm ... 17-10 Activating and Deactivating Respiration Monitoring ... 17-12 Chapter 18: Invasive Blood Pressures (BP) Overview ... 18-1 Caution ... 18-2 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.)

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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 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 ... 21-14 Technical Messages ... 21-15 Chapter 22: Pulse Oximetry (SpO2) Overview ... 22-1 Patient Preparation Checklist ... 22-3 Monitoring Procedures ... 22-6 Accessing the SpO2 Menu ... 22-7 Setting SpO2 Alarms ... 22-7 Setting SpO2 Display Options ... 22-12 Activating and Setting SpO2 Pulse Tones ... 22-13 Setting SpO2 Response Time ... 22-15 Activating SpO2 Monitoring ... 22-16 Masimo Technology ... 22-16 SpO2 Specification ... 22-18 Chapter 23: End Tidal CO2 (EtCO2) Microstream /MicroPod™ Principles of Operation ... 23-1 Intended Use ... 23-2

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Microstream EtCO2 Circuits ... 23-3 Using the MicroPod™ ... 23-4 Patient Preparation Checklist ... 23-5 Cautions and Warnings ... 23-5 Interfering Gasses ... 23-5 Cleaning ... 23-6 Calibration ... 23-6 Sidestream Monitoring for Intubated Patients ... 23-6 Sidestream Monitoring of Non-Intubated Patients ... 23-7 Intubated Sidestream Monitoring ... 23-7 Monitoring Procedures ... 23-7 Accessing the EtCO2 Menu ... 23-8 Setting EtCO2 Alarms ... 23-9 Setting EtCO2 Display Options ... 23-12 IPI ... 23-14 Activating EtCO2 Monitoring ... 23-17 Points to Consider and Possible Causes of Error ... 23-18 Warnings and Precautions ... 23-21 EtCO2 Specifications ... 23-24 Patents ... 23-26

Section 4 Universal Input Module UIM 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: Anesthetic Gas Monitoring Overview ... 25-1 Monitoring Procedures ... 25-1 EtCO2 Monitoring ... 25-2 O2, N2O, and Anesthetic Agent Monitoring Procedures ... 25-9 Activating Monitoring ... 25-16 MAC (Minimum Alveolar Concentration ) ... 25-17

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Chapter 26: Ventilator Overview ... 26-1 Ventilator Parameters ... 26-2 Monitoring Procedures ... 26-2 Ventilator Menu ... 26-3 Setting Alarms ... 26-4 Setting Ventilator Display Options ... 26-7 Activating and Deactivating Ventilator Monitoring ... 26-10 Alarm Messages ... 26-11 Chapter 27: BIS - Bispectral Index Introduction ... 27-1 Installation and Preparation for Use ... 27-4 Operating the VitaLogik 4000/6000 Series BIS ... 27-9 Monitoring Procedures ... 27-11 BIS Monitoring Profile ... 27-22 BIS Cleaning and Preventive Maintenance ... 27-25 Service ... 27-26 BIS Trouble Shooting ... 27-27 Chapter 28: CO/CCO/SvO2 Overview ... 28-1 UIM Input as Vigilance/Vigileo/PiCCO ... 28-3 CO/CCO Monitoring Procedures ... 28-4 SvO2 Monitoring Procedures ... 28-7 Trend ... 28-10 Chart ... 28-10 Chapter 29: Radical 7 – Masimo CO-Oximeter Overview ... 29-1 Technical Alarms ... 29-2 Calibration ... 29-2 Monitoring Procedures ... 29-2 Setting SpO2 Alarms limits ... 29-3 Setting SpHb Alarm Limits ... 29-3 Setting SpCO Alarm Limits ... 29-3 Setting SpMet Alarm Limits ... 29-3 Display Options ... 29-3 Sensors ... 29-4 Chapter 30: CerebraLogik- aEEG and EEG Introduction ... 30-1 CerebraLogik Label ... 30-4 CerebraLogik - Waveforms and Display Modes ... 30-5

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Operating VitaLogik Monitor with CerebraLogik ... 30-6 Technical Alarm ... 30-8 Monitoring Procedures ... 30-8 CerebraLogik Display Modes ... 30-12 aEEG History ... 30-16 EEG Sections ... 30-19 Data Storage and Export ... 30-21 Recording ... 30-25 Printing ... 30-26 Routine Maintenance ... 30-26 Chapter 31: Train Of Four [TOF] Introduction ... 31-1 Interfacing with TOF-Watch ... 31-2 Chapter 32: Recording and Printing Introduction ... 32-1 Network Printer ... 32-1 Enscribe – Network Strip Chart Recorder. ... 32-2 Built-in Strip Chart Recorder. ... 32-6

Section 5 Appendixes Appendix A: Accessories Appendix B: Trouble Shooting ECG/Respiration Monitoring ... B-1 Response to Single Lead Fault ... B-2 Invasive Blood Pressure Monitoring ... B-2 EtCO2 ... B-3

Appendix C: Auto-Set Dynamic Alarm Limits Appendix D: Setting Up the System Introduction ... D-2 Date & Time Setup ... D-8 General Settings ... D-11 Alarm Volume and Controls ... D-14 Sound Event ... D-18 Default Alarm Limits ... D-19 Event Setup ... D-21

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Vital Sign (VS) Setup ... D-23 Parameter Hierarchy ... D-53 Monitor Profiles Setup ... D-55 Admit by Default ... D-58 Report Setup ... D-59 Network Setup ... D-65 IP Address Setup ... D-66 Recorder Setup ... D-66 Trends Setup ... D-68 QuicKeys™ Setup ... D-69 Tabular Charts ... D-70 Software Version ... D-74 Enmove™ Interface Setup ... D-75 Change Password ... D-76 Check Disk ... D-77 Permission Editor ... D-78 Remove Saved Patients ... D-79 Touch Screen Calibration ... D-79 Demo Activation ... D-79 Copy Configuration Utility ... D-80

Appendix E: Setting Up the Interface Between Vigileo and VitaLogik Appendix F: Declaration of conformity to IEC 60601-2-27

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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 Training Mennen Medical or it's authorized distributer will provide training for the system user as per the intended use of the device or system. The training may be personal or by training the trainers. The scope of the training is part of the agreement between Mennen Medical or it's authorized distributer and the end user. It is the responsible of the hospital management that only users that were trained to use the equipment efficiently and safely, should operate the equipment

Service Only Service Engineers trained and approve by Mennen Medical are allowed to perform service to Mennen-Net equipment. Monitor configuration is password protected and is allowed to users that have received permission by the hospital System Manager or administrator. "VitaLogik 4000 and VitaLogik 6000 Service manual" will be provided to Service Engineers trained and approve by Mennen Medical.

Prescription Notice CAUTION!

Federal law restricts this device to sale by or on the order of qualified medical personnel only.

User Capability Patient monitors are used by nurses under the supervision of physicians. System Setup, is password protected and should be modified only by the System Manager authorized by the department director (a Physician)

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What You Should Know

VitaLogik 4000/4500 Part Numbers Table 1: VitaLogik 4000/4500 Part Numbers

Part Number

Description

681-000-010

VitaLogik4000 - Non-Invasive (Nellcor SpO2)

681-000-020

VitaLogik4000 - Non-Invasive (Masimo SpO2)

681-000-110

VitaLogik4500 - Full 2BP (Nellcor SpO2)

681-000-120

VitaLogik4500 - Full 2BP (Masimo SpO2)

681-000-210

VitaLogik4500 - Full 4BP (Nellcor SpO2)

681-000-220

VitaLogik4500 - Full 4BP (Masimo SpO2)

681-OPT-200

Option, EtCO2

681-OPT-001

Flash Memory - 1GB

681-OPT-040

Flash Memory - 8GB

681-OPT-010

Option One Battery

681-OPT-020

Option, Two Battery

681-OPT-014

Option (NON T.S)

681-OPT-012

Option Touch Screen

681-OPT-400

Option RECORDER ASSY

681-OPT-119

Option, Wireless (EU)

681-OPT-219

Option, Wireless (US)

VitaLogik 6000 Part Numbers Table 2: VitaLogik 6000 Part Numbers

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Part Number

Description

781-01E/U-012

VitaLogik 6000: ECG/Resp, SpO2 (Nellcor), NIBP, 2Temp, (EU/US)

781-02E/U-012

VitaLogik 6000: ECG/Resp, SpO2 (Masimo), NIBP, 2Temp (EU/US)

781-03E/U-012

VitaLogik 6000: ECG/Resp, SpO2(Nellcor), NIBP, 4Temp, 2BP, CO (EU/US)

781-04E/U-012

VitaLogik 6000, ECG/Resp, SpO2(Masimo), NIBP, 4Temp, 2BP, CO (EU/US)

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VitaLogik 4000/6000 Series® Operating Manual Table 2: VitaLogik 6000 Part Numbers

Part Number

Description

781-05E/U-012

VitaLogik 6000, ECG/Resp, SpO2(Nellcor), NIBP, 4Temp, 4BP, CO (EU/US)

781-06E/U-012

VitaLogik 6000, ECG/Resp, SpO2(Masimo), NIBP, 4Temp, 4BP, CO (EU/US)

781-OPT-200

Option, EtCO2

781-OPT-001

Flash Memory - 1GB

781-OPT-008

Flash Memory - 8GB

781-OPT-016

Flash Memory - 16GB

781-OPT-010

Option One Battery

781-OPT-020

Option, Two Battery

781-OPT-014

Option (NON T.S)

781-OPT-012

Option Touch Screen

781-OPT-400

Option RECORDER ASSY

781-OPT-119

Option, Wireless (EU)

781-OPT-219

Option, Wireless (US)

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What You Should Know

VitaLogik 4000/6000 Series® Operating Manual

Manual Structure The manual is divided into four sections. •

Section 1 introduces the VitaLogik 4000/6000 Series 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 VitaLogik 4000/6000 Series 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 VitaLogik 4000/6000 Series 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 4000/6000 Series bedside monitor is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik 4000/6000 Series bedside monitor can monitor ECG/Heart Rate, two (four - optional) invasive blood pressure channels, Cardiac Output, temperature, pulse oximetry, respiration non-invasive blood pressure and End tidal CO2. This effectively allows the VitaLogik 4000/6000 Series 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 4000/6000 Series 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:

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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

•

Post-anesthesia care

The VitaLogik 4000/6000 Series monitor is supplied in two models: VitaLogik 4000/6000 Series provides the non-invasive vital signs: ECG, NIBP, SpO2, and Temperature with optional EtCO2. It also has options for full monitoring capacity including: 2 BP (4 - optional) and CO/2 Temp •

VitaLogik 6000 6500 has full monitoring capacity and includes: ECG, NIBP, SpO2, Temperature, 2 (4 - optional) BP and CO/2 Temp with optional EtCO2

Compliance The VitaLogik 4000/6000 Series bedside monitor is designed to comply with the international safety requirements for medical electrical equipment IEC 60601-1, IEC 60601-1-8 , IEC 60601-2-27, IEC 60601-2-49 and AAMI voluntary performance standards for cardiac monitors.. The VitaLogik 4000/6000 Series bedside monitor is also designed to comply with the international EMC requirements for medical electrical equipment IEC 606011-2. European Directive 93/42/EEC as amended by 2007/47/EC, classifies the VitaLogik 4000/6000 Series 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 2-5 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 5 seconds of defibrillation. The VitaLogik 4000/6000 Series is designed as a Type CF equipment to have special protection against electric shocks (particularly regarding leakage current) and is defibrillator proof.

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VitaLogik 4000/6000 Series® Operating Manual

What You Should Know

Network – Mennen-Net VitaLogik 4000/6000 Series and all other Mennen Medical monitors can be connected to a Local Area Network – LAN by wired or wireless connection (optional). The Network enables the Ensemble – Central Nurse Station and the Enguard – Remote Monitor to view patient data at the central station or doctor's room. It also enables each monitor to view remote monitors that are on the Mennen-Net. Interface to Hospital Information System – HIS is also available via a server router.

Figure 1-1: Mennen-Net

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CHAPTER 2: WARNINGS AND PRECAUTIONS The terms Warning, Caution, and Note have specific meanings in this chapter. WARNING!!! advises against certain actions or situations that could result in personal injury or death. CAUTION! advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure, although personal injury is unlikely. NOTE provides useful information regarding a function or procedure. The VitaLogik 4000/6000 Series 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. CAUTION!

Connect the monitor to the main power whenever available. Note that when the monitor works on battery a "Battery" label appears on the display

Power Failure The monitor is equipped with battery backup to ensure continuous monitoring in case of a power failure. However , if a prolonged power failure is expected, it is strongly recommended to use Un Interrupted Power Supply - UPS to ensure continuous monitoring in case of power failure.

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