IntelliVue Patient Monitor - Medaval

11IntroductionThese Instructions for Use are for clinical professionals using the IntelliVue MX400/MX450, MX500/MX550, and MX600/MX700/MX800 patient monitor.This basic operation section gives you an overview of the monitor and its functions. It tells you how toperform tasks that are common to all measurements (such as entering data, switching a measurementon and off, setting up and adjusting wave speeds, working with profiles). The alarms section gives anoverview of alarms. The remaining sections tell you how to perform individual measurements, andhow to care for and maintain the equipment.Familiarize yourself with all instructions including warnings and cautions before starting to monitorpatients. Read and keep the Instructions for Use that come with any accessories, as these containimportant information about care and cleaning that is not repeated here.This guide describes all features and options. Your monitor may not have all of them; they are not allavailable in all geographies. Your monitor is highly configurable. What you see on the screen, how themenus appear and so forth, depends on the way it has been tailored for your hospital and may not beexactly as shown here.In this guide: A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure toobserve a warning may result in death or serious injury to the user or patient. A caution alerts you to where special care is necessary for the safe and effective use of theproduct. Failure to observe a caution may result in minor or moderate personal injury or damageto the product or other property, and possibly in a remote risk of more serious injury.MX400/ Whenever a monitor's identifier appears to the left of a heading or paragraph, it means that theMX450 information applies to that monitor only. Where the information applies to all models, no distinction ismade.For installation, repair, testing and troubleshooting instructions, refer to the Service Guide for yourmonitor model.Rx only: U.S. Federal Law restricts this device to sale by or on the order of a physician.13

1 IntroductionSafety InformationThe following warnings apply to the monitors in general. Warnings that apply to specificmeasurements or procedures can be found in the corresponding chapters.Electrical Hazards and InterferenceWARNINGGrounding: To avoid the risk of electric shock, the monitor must be grounded during operation. If athree-wire receptacle is not available, consult the hospital electrician. Never use a three-wire to twowire adapter.Electrical shock hazard: Do not open the monitor or measurement device. Contact with exposedelectrical components may cause electrical shock. Refer servicing to qualified service personnel.Leakage currents: If multiple instruments are connected to a patient, the sum of the leakage currentsmay exceed the limits given in IEC/EN 60601-1, IEC 60601-1-1, UL 60601-1. Consult your servicepersonnel.Radio frequency interference: The monitor generates, uses and radiates radio-frequency energy, andif it is not installed and used in accordance with its accompanying documentation, may causeinterference to radio communications.Use EnvironmentWARNINGExplosion Hazard: Do not use in the presence of flammable anesthetics or gases, such as aflammable anesthetic mixture with air, oxygen or nitrous oxide. Use of the devices in such anenvironment may present an explosion hazard.Positioning Equipment: The monitor should not be used next to or stacked with other equipment.If you must stack the monitor, check that normal operation is possible in the necessary configurationbefore you start monitoring patients.Environmental Specifications: The performance specifications for the monitors, measurements andaccessories apply only for use within the temperature, humidity and altitude ranges specified in“Environmental Specifications” on page 458.Liquid Ingress: If you spill liquid on the equipment, battery, or accessories, or they are accidentallyimmersed in liquid, contact your service personnel or Philips service engineer. Do not operate theequipment before it has been tested and approved for further use.Prohibited Environments: The monitors are not intended for use in an MRI environment or in anoxygen-enriched environment (for example, hyperbaric chambers).14

1 IntroductionAlarmsWARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarmvolume to a low level or off during patient monitoring may result in patient danger. Rememberthat the most reliable method of patient monitoring combines close personal surveillance withcorrect operation of monitoring equipment. Be aware that the monitors in your care area may each have different alarm settings, to suitdifferent patients. Always check that the alarm settings are appropriate for your patient before youstart monitoring.AccessoriesWARNINGPhilips' approval: Use only Philips-approved accessories. Using other accessories may compromisedevice functionality and system performance and cause a potential hazard.Reuse: Never reuse disposable transducers, sensors, accessories and so forth that are intended forsingle use, or single patient use only. Reuse may compromise device functionality and systemperformance and cause a potential hazard.Electromagnetic compatibility: Using accessories other than those specified may result in increasedelectromagnetic emission or decreased electromagnetic immunity of the monitoring equipment.Damage: Do not use a damaged sensor or one with exposed electrical contacts.Cables and tubing: Always position cables and tubing carefully to avoid entanglement or potentialstrangulation.MR Imaging: During MR imaging, remove all transducers, sensors and cables from the patient.Induced currents could cause burns.Security InformationProtecting Personal InformationProtecting personal health information is a primary component of a security strategy. Each facilityusing the monitors must provide the protective means necessary to safeguard personal informationconsistent with country laws and regulations, and consistent with the facility’s policies for managingthis information. Protection can only be realized if you implement a comprehensive, multi-layeredstrategy (including policies, processes, and technologies) to protect information and systems fromexternal and internal threats.As per its intended use, the patient monitor operates in the patient vicinity and contains personal andsensitive patient data. It also includes controls to allow you to adapt the monitor to the patient's caremodel. To ensure the patient's safety and protect their personal health information you need a securityconcept that includes:15

1 Introduction Physical security access measures - access to the monitor must be limited to authorized users.It is essential that you consider physical security measures to ensure that unauthorized userscannot gain access. Operational security measures - for example, ensuring that patients are discharged aftermonitoring in order to remove their data from the monitor. Procedural security measures - for example, assigning only staff with a specific role the right touse the monitors.In addition, any security concept must consider the requirements of local country laws and regulations.Always consider data security aspects of the network topology and configuration when connectingpatient monitors to shared networks. Your medical facility is responsible for the security of thenetwork, where sensitive patient data from the monitor may be transferred.Note: Log files generated by the monitors and measurement modules are used for systemtroubleshooting and do not contain patient data.About HIPAA RulesIf applicable, your facility’s security strategy should include the standards set forth in the HealthInsurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United StatesDepartment of Health and Human Services. You should consider both the security and the privacyrules and the HITECH Act when designing policies and procedures. For more information, pleasevisit http://www.hhs.gov/ocr/privacy/.About the EU DirectivesIf applicable, your facility’s security strategy should include the practices set forth in the Directive onthe protection of individuals with regard to the processing of personal data and on the free movementof such data (Directive 95/46/EC of the European Parliament and of the Council of24 October 1995). In addition, your facility should also take into account any additional, morestringent standards put forward by any individual EU countries; that is, Germany, France, and so on.For more information, please visit http://eur-lex.europa.eu/en/dossier/dossier 27.htm.Philips Product Security Policy StatementAdditional security and privacy information can be found on the Philips product security web site ufacturer Disclosure Statement for Medical Device Security –MDS2You can view the Manufacturer Disclosure Statements for Medical Device Security (MDS2) forspecific devices at ducing the MonitorThe IntelliVue MX400/MX450, MX500/MX550, and MX600/MX700/MX800 patient monitoroffers a monitoring solution optimized for the high-end surgical, cardiac, medical and neonatal careenvironments. Combining patient surveillance and data management, it allows multi-measurementmonitoring by linking separate modules. The MX600 uses the navigation knob as primary input device16

1 Introductionand the MX400/MX450, MX500/MX550, and MX700/MX800 use the touch screen as primary inputdevice. All monitors have a remote control for convenient access to the five main keys and numericdata input.The monitor stores data in trend, event, and calculation databases. You can see tabular trends (vitalsigns) and document them on a printer. You can view measurement trend graphs, with up to threemeasurements combined in each graph, to help you identify changes in the patient's physiologicalcondition. You can view fast-changing measurement trends with beat to beat resolution and see up tofour high resolution trend segments. Event surveillance enhances documentation and review ofphysiologically significant events by automatically detecting and storing up to 50 user-defined clinicalevents over a 24 hour period.MX600/700/ With the optional Integrated PC, you have computer functionality directly in the monitor. You can use800 standard applications (e.g. Web browsers), connect to the hospital network or intranet, and run asecond independent display with content from the patient monitor.An IntelliVue X2 can be connected to your monitor, where it acts as a multi-measurement module,acquiring measurements for the host monitor. When the X2 is disconnected from the original hostmonitor, it continues to monitor the patient as a fully independent, battery powered patient monitor,eliminating the need for a separate transport monitor. On connection to a new host monitor, the X2resumes its role as multi-measurement module, ensuring fully continuous monitoring.Major Parts and KeysMX400/450/500/550The MX400/450/500/550 monitors have the same parts, controls and indicators. Here the MX400 isshown.12345678Color coded alarm lampsAlarms Off lampPower on/Standby switch withintegrated LED: Green - On/Standby, Red - ErrorAC power LEDBattery LEDMounting quick-release lever(when this is pressed themonitor is not fixed on themounting)Service number and serialnumberDevice type17

1 IntroductionMX600/70012345678Color coded alarm lampsAlarms Off lampPower on/Standby switch withintegrated LED: Green - On/Standby, Red - ErrorAC power LEDMounting quick-release lever(when this is pressed themonitor is not fixed on themounting)Part number and serial numberHardkeys (Silence, Alarms Off,Main Screen)Navigation knobMX800123456Color coded alarm lampsAlarms Off lampPower on/Standby switch withintegrated LED: Green - On/Standby, Red - ErrorAC power LEDMounting quick-release lever(when this is pressed themonitor is not fixed on themounting)Part number and serial numberDevices for Acquiring MeasurementsThe patient monitor acquires patient measurements using the devices described in this section. Youcan also extend the measurement capabilities of your monitor with such devices. Of thesemeasurement devices, only the X2 has its own power on/standby switch, and can be powered from anexternal power supply or a rechargeable battery when not directly connected to the monitor (refer tothe IntelliVue X2 Instructions for Use for details). All the rest take their power exclusively from the18

1 Introductionmonitor, and switch on automatically when you turn on the monitor. A green power-on LED indicateswhen they are drawing power from the monitor. A permanently illuminated, or flashing, red LEDindicates a problem with the unit that requires the attention of qualified service personnel.All symbols used on the front panels are explained in “Symbols” on page 445.WARNINGWhen connecting devices for acquiring measurements, always position cables and tubing carefully toavoid entanglement or potential strangulation.Flexible Module Rack (M8048A)MX600/ The 8-slot flexible module rack (FMS-8) lets you use up to eight plug-in physiological measurementMX700/ modules. For the MX800, you can connect two FMSs to use up to 10 measurement modules.MX800 The maximum number of specific module types that can be used simultaneously in an FMS-8 is: fivepressure modules, four temperature modules, four VueLink or IntelliBridge modules (anycombination).When two FMSs are used, in total a maximum of 10 pressure modules can be used.Connect the FMS to the monitor via the measurement link cable (MSL). Use the MSL connector onthe left-hand side to connect an additional MMS. Use the connector on the right to connect to themonitor.12345X1 Multi-Measurement ModuleMulti-Measurement ModulemountFlexible Module Rack FMS-8Power on LEDInterruption indicator4-Slot Flexible Module Rack (FMS-4)MX600/ The 4-Slot flexible module rack (FMS-4) lets you use up to four plug-in physiological measurementMX700/ modules.MX80019

1 IntroductionThe maximum number of specific module types that can be used simultaneously in an FMS-4 is: fourpressure modules, four temperature modules, four VueLink or IntelliBridge modules (anycombination).Connect the FMS to the monitor via the measurement link cable (MSL). Use the MSL connector onthe left-hand side (if you have the appropriate option) to connect an additional MMS. Use theconnector on the back to connect to the monitor.Measurement ModulesMX500/ You can use up to three plug-in modules in the optional module slots. Available modules are:MX550 Invasive blood pressure (M1006B) Temperature (M1029A) Oxygen saturation of arterial blood (SpO2) (M1020B) Cardiac output (M1012A), and Continuous cardiac output with M1012A Option #C10 Intravascular Oxygen Saturation - ScvO2 or SvO2 (M1011A) Spirometry (M1014A) EEG (M1027A) NMT (865383) IntelliBridge EC10 (865115) Recorder (M1116B/C)MX600/ You can use up to eight measurement modules with the Flexible Module Rack (M8048A). AvailableMX700/ modules are:MX800 Invasive blood pressure (M1006B) Temperature (M1029A) Oxygen saturation of arterial blood (SpO2) (M1020B) Cardiac output (M1012A), and Continuous cardiac output with M1012A Option #C10 Transcutaneous gas (M1018A) Mixed venous oxygen saturation - SvO2 (M1021A) Intravascular Oxygen Saturation - ScvO2 or SvO2 (M1011A) EEG (M1027A) Bispectral Index - BIS (M1034A) Spirometry (M1014A) NMT (865383) VueLink device interface (M1032A) IntelliBridge EC10 (865115) Recorder (M1116B/C)MX500/550/ You can plug in and unplug modules during monitoring. Insert the module until the lever on the600/700/800 module clicks into place. Remove a module by pressing the lever upwards and pulling the module out.A measurement automatically switches on when you plug the module in, and switches off when you20

1 Introductionunplug it. Reconnecting a module to the same monitor restores its label and measurement settings,such as alarms limits. If you connect it to a different monitor, the module remembers only its label.The connector socket on the front of each module is the same color as the corresponding connectorplug on the transducer or patient cable.Press the Setup key on the module's front to display the measurement's setup menu on the monitorscreen. When the setup menu is open, a light appears above the key. Some modules have a second key.On the pressure module, for example, it initiates a zeroing procedure.Example Module (SpO2)MX500/550/600/700/8001Module name2Setup key LED3Setup key to enter setup menu of measurement modules orexternal device data window. Some modules have a secondmodule-specific key next to this one, for example Zero.4Connector socket for patient cable/transducerX1 Multi-Measurement Module (M3001A)The X1 Multi-Measurement Module (MMS) can simultaneously monitor 3-, 5-, 6- or 10-lead ECG(including arrhythmia and ST monitoring), respiration, SpO2, NBP and either invasive pressure ortemperature.You can connect it to the monitor via a cable or mount it on the left side of the FMS.21

1 IntroductionX1 Connectors and Symbols1White ECG/Resp connector2Blue SpO2 connector3Red NBP connector4Combined pressure (red) and temperature(brown) connector - connect either invasivepressure transducer or temperature probe.You might have a version of the MMS thatdoes not have this connector.5NBP STAT key - starts NBP STAT seriesof measurementsorZero key - initiates a zero procedure for theconnected pressure transducer whenpressed and held for a second6NBP Start/Stop key - starts or stops NBPmeasurements7Silence: acknowledges all active alarms byswitching off audible alarm indicators andlampsX2 Multi-Measurement Module (M3002A)The X2 Multi-Measurement Module (MMS) can simultaneously monitor 3-, 5-, 6- or 10-lead ECG(including arrhythmia and ST monitoring), respiration, SpO2, NBP and either invasive pressure andtemp

Changing Monitor Settings 47 Checking Your Monitor Revision 48 Getting Started 48 Disconnecting from Power 49 Networked Monitoring 50 Using the Integrated PC 50 Using Your Monitor with a Monitor in Companion Mode 52 2 What's New? 55 What's New in Release K.1 (for MX400/450/500/550 only) 55 What's New in Release K.0 55 What's New in Release J.0 .