Instructions for Use Vista 120 WARNING To properly use this medical device, read and comply with these Instructions for Use. Patient Monitor Software 1.n Release date April 25 2011 Screen images Schematic renderings of screen images are used, which may differ in appearance or in configuration from the actual screen images. Definition of Safety Information This guide is designed to give key concepts on safety precautions. WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property. NOTE: A NOTE provides additional information intended to avoid inconvenience during operation. Abbreviations and Symbols For explanations refer to sections “Abbreviations” and “Symbols” in chapter “Overview”. Table of Contents For Your Safety and that of Your Patients....................................................................... 1 General safety information.......................................................................................................1 Strictly follow these Instructions for Use ........................................................................1 Maintenance.......................................................................................................................1 Accessories ........................................................................................................................1 Connected devices............................................................................................................2 Not for use in areas of explosion hazard .......................................................................2 Safe connection with other electrical equipment..........................................................2 Patient safety .....................................................................................................................2 Information on Electromagnetic Compatibility ..............................................................3 Sterile accessories ............................................................................................................3 Installing accessories........................................................................................................3 Product-specific safety information.........................................................................................3 Application......................................................................................................................... 6 Intended use...............................................................................................................................6 Restrictions for use ...................................................................................................................6 Overview ............................................................................................................................ 7 Front view ...................................................................................................................................8 Side view...................................................................................................................................10 Back view.................................................................................................................................. 11 Abbreviations ...........................................................................................................................12 Symbols ....................................................................................................................................14 Vista 120 configuration ...........................................................................................................15 Getting started................................................................................................................. 16 Initial inspection .......................................................................................................................16 Installing the monitor...............................................................................................................16 Installing the monitor on a flat surface .........................................................................16 Installing the monitor on a wall ......................................................................................16 Installing the monitor on a roll stand/trolley .................................................................16 Connecting the power cord ....................................................................................................16 Checking the monitor ..............................................................................................................16 Checking the strip recorder....................................................................................................17 Setting the date and time .......................................................................................................17 System Configuration..................................................................................................... 18 Opening User Maintain Menu................................................................................................18 Entering Demo Mode ..............................................................................................................18 Selecting Lead Placement .....................................................................................................18 I Operation ......................................................................................................................... 19 Using keys ................................................................................................................................20 Changing monitor settings .....................................................................................................21 Adjusting screen brightness...........................................................................................21 Changing date and time .................................................................................................22 Adjusting volume .....................................................................................................................22 Adjusting key volume ......................................................................................................22 Adjusting alarm volume ..................................................................................................22 Adjusting beat volume ....................................................................................................22 Checking the monitor version ................................................................................................22 Setting languages....................................................................................................................22 Understanding screens...........................................................................................................23 Calibrating screens .................................................................................................................23 Alarms.............................................................................................................................. 24 Alarm category.........................................................................................................................24 Physiological alarms .......................................................................................................24 Technical alarms ..............................................................................................................24 Prompts.............................................................................................................................24 Alarm levels ..............................................................................................................................24 Controlling alarm .....................................................................................................................25 Switching the individual alarm off..................................................................................25 Temporary alarm mute....................................................................................................25 Alarm mute .......................................................................................................................25 Setting alarm limits ..........................................................................................................25 Latching alarms........................................................................................................................26 Testing alarms ..........................................................................................................................26 Alarm information ........................................................................................................... 27 Physiological alarm information ............................................................................................27 Technical alarm information ...................................................................................................30 Prompts.....................................................................................................................................35 Adjustable range of alarm limits ............................................................................................37 Managing patients........................................................................................................... 39 Admitting a patient...................................................................................................................39 Patient category and paced status ...............................................................................39 Quick admit...............................................................................................................................40 Editing patient information......................................................................................................40 Update a patient ......................................................................................................................40 User interface .................................................................................................................. 41 Setting interface style .............................................................................................................41 Selecting display parameters ................................................................................................41 Changing waveform position .................................................................................................41 Changing interface layout ......................................................................................................41 Viewing short trend screen ....................................................................................................41 Viewing OxyCRG screen........................................................................................................41 Viewing large font screen.......................................................................................................42 II Monitoring ECG............................................................................................................... 43 Overview ...................................................................................................................................43 ECG safety information ..........................................................................................................43 ECG display..............................................................................................................................44 Changing the size of the ECG waveform ....................................................................44 Changing the ECG filter settings...................................................................................45 Using ECG alarms...................................................................................................................45 Selecting calculation lead.......................................................................................................45 Monitoring procedure ..............................................................................................................46 Preparation .......................................................................................................................46 Connecting ECG cables .................................................................................................46 Selecting lead type ..................................................................................................................46 Installing electrodes ................................................................................................................46 Electrode placement for 3-lead .....................................................................................47 Electrode placement for 5-lead .....................................................................................47 Recommended ECG lead placement for surgical patients .......................................49 ECG menu setup .....................................................................................................................50 Setting alarm source .......................................................................................................50 Smart lead off...................................................................................................................50 Setting beat volume ........................................................................................................50 ECG display......................................................................................................................50 Setting pace status..........................................................................................................51 ECG calibration................................................................................................................51 ECG waveform settings..................................................................................................51 ST segment monitoring ..........................................................................................................51 Setting ST analysis..........................................................................................................52 ST display .........................................................................................................................52 ST analysis alarm setting ...............................................................................................52 About ST measurement points......................................................................................52 Adjusting ST and ISO measurement points ................................................................53 Arrhythmia monitoring.............................................................................................................53 Arrhythmia analysis.........................................................................................................53 ARR ANALYSIS menu ....................................................................................................55 Monitoring RESP............................................................................................................. 56 Overview ...................................................................................................................................56 RESP safety information ........................................................................................................56 Resp display.............................................................................................................................56 Electrode placement for monitoring resp.............................................................................56 Cardiac overlay ........................................................................................................................57 Chest expansion ......................................................................................................................57 Abdominal breathing ...............................................................................................................57 Selecting resp lead..................................................................................................................57 Changing hold type .................................................................................................................58 Changing the size of the respiration waveform ..................................................................58 Using Resp alarms ..................................................................................................................58 Changing the apnea time .......................................................................................................58 III Monitoring SpO2 .............................................................................................................. 59 Overview ...................................................................................................................................59 SpO2 safety information..........................................................................................................59 Measuring SpO2 .......................................................................................................................60 Measurement procedure ........................................................................................................60 Understanding SpO2 alarms ..................................................................................................61 Adjusting alarm limits ..............................................................................................................61 Setting SpO2 as pulse source................................................................................................61 Setting pitch tone.....................................................................................................................61 Setting sensitivity.....................................................................................................................61 Monitoring PR.................................................................................................................. 62 Overview ...................................................................................................................................62 Setting PR volume...................................................................................................................62 Using pulse alarms..................................................................................................................62 Selecting the active alarm source.........................................................................................62 Monitoring NIBP .............................................................................................................. 63 Overview ...................................................................................................................................63 NIBP safety information..........................................................................................................63 Measurement limitations ........................................................................................................64 Measurement methods...........................................................................................................64 Measurement procedures ......................................................................................................65 Operation prompts...................................................................................................................66 Correcting the measurement if limb is not at heart Level .................................................66 NIBP alarm ...............................................................................................................................66 Resetting NIBP ........................................................................................................................66 Calibrating NIBP ......................................................................................................................67 Leak test ...................................................................................................................................67 Procedure for leak testing ..............................................................................................67 Monitoring TEMP............................................................................................................. 68 Overview ...................................................................................................................................68 TEMP safety information ........................................................................................................68 TEMP monitoring setup ..........................................................................................................68 Calculating temp difference ...................................................................................................68 Monitoring IBP (optional)................................................................................................ 69 Overview ...................................................................................................................................69 IBP safety information.............................................................................................................69 Monitoring procedures ............................................................................................................69 Selecting a pressure for monitoring......................................................................................70 Zeroing the pressure transducer...........................................................................................70 Troubleshooting the pressure zeroing (taking art for example) .......................................71 IBP pressure calibration .........................................................................................................71 Troubleshooting the pressure calibration.............................................................................72 IBP alarm ..................................................................................................................................73 IV Monitoring CO2 (optional) ............................................................................................... 74 Overview ...................................................................................................................................74 CO2 safety information............................................................................................................74 Monitoring procedures ............................................................................................................75 Zeroing the sensor ..........................................................................................................75 C5 CO2 module................................................................................................................75 Setting CO2 waveform setup .................................................................................................77 Setting CO2 corrections ..........................................................................................................77 Changing CO2 alarms.............................................................................................................77 Changing apnea alarm ...........................................................................................................78 Freeze............................................................................................................................... 79 Overview ...................................................................................................................................79 Entering/exiting freeze status ................................................................................................79 Entering freeze status.....................................................................................................79 Exiting freeze status........................................................................................................79 Reviewing frozen waveform...................................................................................................80 Review.............................................................................................................................. 81 Trend graph review .................................................................................................................81 Selecting trend graph of specific parameter................................................................81 Setting resolution.............................................................................................................81 Scrolling the screen.........................................................................................................81 Switching to the trend table............................................................................................82 Record...............................................................................................................................82 Trend table review ...................................................................................................................82 Setting resolution.............................................................................................................82 Scrolling the screen.........................................................................................................82 Switching to trend graph.................................................................................................82 Recording .........................................................................................................................83 NIBP review..............................................................................................................................83 Scrolling the screen.........................................................................................................83 Recording .........................................................................................................................83 Alarm review.............................................................................................................................83 Scrolling the screen.........................................................................................................83 Selecting alarm event of specific parameter ...............................................................83 Setting time index ............................................................................................................83 Recording .........................................................................................................................84 Arr review..................................................................................................................................84 Selecting specific arrhythmia event ..............................................................................84 Scrolling the screen.........................................................................................................84 Deleting arrhythmia events ............................................................................................84 Recording .........................................................................................................................84 Calculation and titration table........................................................................................ 85 Drug calculation .......................................................................................................................85 Calculation procedures...................................................................................................85 Calculation unit ................................................................................................................86 Titration table............................................................................................................................86 V Strip recording ................................................................................................................ 87 General information.................................................................................................................87 Performance of the recorder..................................................................................................87 Recording type.........................................................................................................................87 Starting and stopping strip recording....................................................................................88 Recorder operations and status messages.........................................................................89 Record paper requirement .............................................................................................89 Proper operation ..............................................................................................................89 Paper out ..........................................................................................................................89 Installling paper................................................................................................................89 Removing paper jam.......................................................................................................91 Other Functions .............................................................................................................. 92 Nurse call ..................................................................................................................................92 Using battery ................................................................................................................... 93 Battery power indicator...........................................................................................................93 Battery status on the main screen ........................................................................................93 Checking battery performance ..............................................................................................93 Replacing the battery ..............................................................................................................94 Recycling the battery ..............................................................................................................95 Care and cleaning ........................................................................................................... 96 General points..........................................................................................................................96 Cleaning ....................................................................................................................................96 Cleaning the monitor.......................................................................................................96 Cleaning the accessories ...............................................................................................97 Sterilization ...............................................................................................................................98 Disinfection ...............................................................................................................................98 Maintenance .................................................................................................................... 99 Inspecting .................................................................................................................................99 Maintenance task and test schedule ....................................................................................99 Replacing fuse .......................................................................................................................100 Disposal ......................................................................................................................... 101 Service policy ................................................................................................................ 102 Accessories ................................................................................................................... 103 ECG accessories...........................................................................................................103 SpO2 accessories ..........................................................................................................104 NIBP accessories ..........................................................................................................104 Temp accessories..........................................................................................................105 IBP accessories .............................................................................................................105 CO2 accessories ............................................................................................................105 Device accessories .......................................................................................................105 Spare parts .....................................................................................................................105 VI Technical Data ............................................................................................................... 106 Classification ..........................................................................................................................106 Device specifications ............................................................................................................106 Ambient conditions ................................................................................................................106 Leakage current.....................................................................................................................106 Power supply..........................................................................................................................107 Display.....................................................................................................................................107 Recorder .................................................................................................................................107 Review.....................................................................................................................................108 ECG .........................................................................................................................................108 3-, 5-lead monitoring .....................................................................................................108 RESP....................................................................................................................................... 111 NIBP ........................................................................................................................................ 112 SpO2 ........................................................................................................................................ 113 TEMP....................................................................................................................................... 114 IBP ........................................................................................................................................... 114 CO2 .......................................................................................................................................... 114 EMC Declaration.............................................................................................................116 General information............................................................................................................... 116 Electromagnetic emissions .................................................................................................. 116 Electromagnetic environment .............................................................................................. 116 Electromagnetic immunity .................................................................................................... 117 Recommended separation distances to portable and mobile RF telecommunication devices ....................................................................................................................................120 Default settings ............................................................................................................. 121 Patient information default settings ....................................................................................121 Alarm default settings ...........................................................................................................121 ECG default settings .............................................................................................................121 RESP.......................................................................................................................................123 SpO2........................................................................................................................................123 PR ............................................................................................................................................123 NIBP ........................................................................................................................................124 TEMP.......................................................................................................................................124 IBP ...........................................................................................................................................125 CO2 ..........................................................................................................................................125 Passwords ..................................................................................................................... 128 VII Instructions for Use Vista 120 Patient Monitor For Your Safety and that of Your Patients General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these Instructions for Use or in the Instructions for Use of another product being used with this device. Strictly follow these Instructions for Use WARNING Any use of the medical device requires full understanding and strict observation of all sections of these Instructions for Use. The medical device must only be used for the purpose specified under "Intended Use". Strictly observe all WARNING and CAUTION statements throughout these Instructions for Use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use. Maintenance WARNING The medical device must be inspected and serviced regularly by professionals who possess the required qualifications due to their training and their experience. Repair of the medical device must also be performed by trained personnel with additional product-specific DrägerService training. Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. Dräger further recommends that only authentic Dräger repair parts are used for maintenance. If the above are not complied with, the correct functioning of the medical device may be compromised. See chapter "Maintenance". Accessories WARNING Only the accessories indicated on the chapter “Accessories” have been tested and approved for use with the medical device. Therefore, it is strongly recommended that only these accessories are used in conjunction with the medical device. Otherwise, the correct functioning of the medical device may be compromised. -1- Instructions for Use Vista 120 Patient Monitor Connected devices WARNING Risk of electric shock and of device malfunction. Any connected devices or device combinations not complying with the requirements mentioned in these Instructions for Use may compromise the correct functioning of the medical device. Before operating any combination of devices, refer to and strictly comply with the Instructions for Use for all connected devices and device combinations. Not for use in areas of explosion hazard WARNING Not for use in areas of explosion hazard This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur. Safe connection with other electrical equipment CAUTION Risk of patient injury Electrical connections to equipment not listed in these Instructions for Use or these Assembly Instructions must only be made when approved by each respective manufacturer. Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to professionals, and that certain inherent characteristics of the medical device are known to the user. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. These Instructions for Use do not contain references to various hazards which are obvious to professionals who operate this medical device as well as references to the consequences of medical device misuse, and to potentially adverse effects in patients with different underlying diseases. Medical device modification or misuse can be dangerous. CAUTION Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring parameters. -2- Instructions for Use Vista 120 Patient Monitor Information on Electromagnetic Compatibility General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2: Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided in this Instructions for Use. Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Do not connect connectors with an ESD warning symbol and do not touch the pins of such connectors without implementing ESD protective measures. Such protective measures may include antistatic clothing and shoes, touching a ground stud before and during connection of the pins, or using electrically insulating and antistatic gloves. All relevant personnel must be instructed in these ESD protective measures. Sterile accessories CAUTION Do not use sterile-packaged accessories if the packaging has been opened, is damaged or there are other signs of non-sterility. Disposable articles must not be reprocessed and resterilized. Reuse, reprocessing, or resterilization can lead to a failure of the medical device and cause injury to the patient. Installing accessories CAUTION Install accessories to the basic device in accordance with the Instructions for Use of the basic device. Make sure that there is a safe connection to the basic device system. Strictly observe Assembly Instructions and Instructions for Use. Product-specific safety information WARNING Before using Vista 120, patient cables, electrodes etc. should be checked. Replacement should be taken if there is any evident defect or signs of aging which may impair the safety or performance. WARNING The power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet. -3- Instructions for Use Vista 120 Patient Monitor WARNING Route all cables away from patient’s throat to avoid possible strangulation. WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. WARNING When interfacing with other equipment, a test for leakage current must be performed by qualified hospital technical personnel before using with patients. WARNING During monitoring, if the power supply is off and there is no battery for standby, the monitor will be off. After reconnecting the power supply, the user should turn on the monitor for monitoring. WARNING Keep away from fire immediately when leakage or foul odor is detected. WARNING The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, contact your local Dräger sales representative. WARNING This equipment is not intended for home usage. WARNING Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g., IEC 60950 “Safety standards for information technology equipment” and IEC 60601-1 “Safety standards for medical electrical equipment”) The system configuration must meet the requirements of the IEC 60601-1-1 “Medical electrical systems” standard. Any personnel who connect devices to the equipment’s signal input/output port is responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1-1. CAUTION Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid pouring fluids directly on the transducer. -4- Instructions for Use Vista 120 Patient Monitor CAUTION Do not use autoclave or gas to sterilize the monitor, recorder or any accessories. CAUTION Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur. CAUTION Remove a battery whose life cycle has expired from the monitor immediately. CAUTION Avoid liquid splash on the device. The temperature must be kept between 5 and 40 °C while working. And it should be kept between -20 and +55°C during transportation and storage. NOTE • Position the device in a location where the operator can easily see the screen and access the operating controls. • The monitor can only be used on one patient at a time. • If the monitor gets damp, put it in dry circumstance to dry it until it can work normally. If liquid pours on the monitor, contact DrägerService. • Do not use this monitor for diagnostic purposes. • When the monitor is shut off, only the patient information and alarm settings can be saved. • The pictures and dialog boxes in these Instructions for Use are for reference only. • Regular preventive maintenance should be carried every two years. The user is responsible for any requirements specific to their country. -5- Instructions for Use Vista 120 Patient Monitor Application Intended use The Vista 120 monitors parameters such as ECG (3-lead or 5-lead selectable), respiration (RESP), functional arterial oxygen saturation (SpO2), invasive or non-invasive blood pressure (dual-IBP, NIBP), temperature (dual-TEMP), and expired CO2. Vista 120 is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility. Restrictions for use CAUTION Device for use in health care facilities only and exclusively by persons with specific training and experience in its use. -6- Instructions for Use Vista 120 Patient Monitor Overview Vista 120 is optimized for surgical, cardiac, medical and neonatal care environments, and can store data for both trends and events. The user can also view and record graphical and tabular trends (vital signs). Vista 120 has a 15-inch TFT color flat panel display. Up to 11 waveforms can be displayed on the screen. -7- Instructions for Use Vista 120 Patient Monitor Front view A B C D E F G H J I A B Alarm indicator Alarm Mute When an alarm occurs, the alarm indicator will light or flash. The alarm level is color coded. Press this button to pause the alarm. All audio alarms stop and the are displayed in the Temporary Alarm Mute **s and the symbol information area. If the user presses the button again or if the pause time ends, the system will resume normal monitoring status and the Temporary Alarm Pause **s and icon will clear. D E NIBP measurement Trend Freeze F Recording G H Menu Rotary Knob C The symbol is displayed in the information area. Pressing or holding the button again resumes the alarm. Press to inflate the cuff and perform NIBP measurement. Press again to stop the measurement and deflate the cuff. Press this button to enter trend table review dialog box. In normal mode, press this button to freeze all the waveforms on the screen. In Freeze mode, press this button to restore the waveform refreshing. Press this button to start a real-time recording. Press again to stop recording. Press to return to the main dialog box. The user can turn the rotary knob clockwise or counter-clockwise to -8- Instructions for Use Vista 120 Patient Monitor highlight the desired item. Press the rotary knob to select the item. Mains/Battery Refer to chapter “Battery power indicator” for details. I indicator On/Off When connected to the AC power supply, press the key to turn the monitor J on. Press the key again to turn the monitor off. Further Alarm Mute information can be found in the chapter “Audio Off”. -9- Instructions for Use Vista 120 Patient Monitor Side view A B C D I E F G H J A B C D E F G H I J NIBP port ECG port etCO2 port SpO2 port T1 port T2 port IBP 1 port IBP 2 port Recorder Battery compartment door - 10 - Instructions for Use Vista 120 Patient Monitor Back view A L K J B I C H G A B C D E F G H I J K L F E D Fan Speaker Equipotential grounding terminal. If the monitor is used with other devices, connect this terminal to eliminate potential ground differences between devices. Security lock. Used to prevent the power cord from detaching. Ventilation grid Anti-theft lock USB interface. This port is used to connect the USB device. RJ45 network interface RS232 interface VGA output Analog output. Vista 120 outputs the waveform through the auxiliary output port. Nurse Call port. This port may be connected to an external nurse call system, not provided by Dräger. - 11 - Instructions for Use Vista 120 Patient Monitor Abbreviations Abbr. Explanation Abbr. Explanation AC Alternating current Adu Adult AHA American Heart Association Art Arterial aVF Left foot augmented lead aVL Left arm augmented lead aVR Right arm augmented lead awRR Airway respiration rate BP Blood pressure BTPS Body temperature and pressure, saturated CISPR International Special Committee on Radio Interference CO2 Carbon dioxide COHb Carboxyhemoglobin CVP Central venous pressure DC Direct current Dia Diastolic ECG Electrocardiogram EEC European Economic Community EMC Electromagnetic compatibility EMI Electromagnetic interference ESU Electrosurgical unit et End-tidal etCO2 End-tidal carbon dioxide FCC Federal Communication Commission FiCO2 Fraction of inspired carbon dioxide Hb Hemoglobin Hb-CO Carboxyhemoglobin HR Heart rate IBP Invasive blood pressure ICP Intracranial pressure ICU Intensive care unit ID Identification IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronic Engineers LA Left arm LAP Left arterial pressure LCD Liquid crystal display LED Light emitting diode LL Left leg MAP Mean arterial pressure MDD Medical Device Directive MetHb Methemoglobin N/A Not applicable Neo Neonate NIBP Non-invasive blood pressure O2 Oxygen oxyCRG Oxygen cardio-respirogram PA Pulmonary artery PAWP Pulmonary artery wedge pressure Ped Pediatric Pleth Plethysmogram PR Pulse rate PVC Premature ventricular complex R Right - 12 - Instructions for Use Vista 120 Patient Monitor Abbr. Explanation Abbr. Explanation RA Right arm RAP Right arterial pressure Resp Respiration RHb Reduced hemoglobin RL Right leg RR Respiration Rate SYS Systolic pressure TD Temperature difference USB Universal serial bus TEMP Temperature - 13 - Instructions for Use Vista 120 Patient Monitor Symbols Alarm Pause USB port NIBP measurement RS232 port Trend graph VGA output, External Monitor Freeze Signal output port Recording Signal output port Menu Nurse call port Locked position Protection class type CF (defibrillation-protected) Battery indicator Defibrillation-proof type BF applied part Alternating current Mains indicator Serial number Power supply switch Equipotential bonding Disposal instructions Caution Recycle Network port Part number Manufacturer Conformitè Europèenne Directive 93/42/EEC concerning medical products Date of manufacture China RoHS (Restriction of Hazardous Substances) label GOST label Consult Instructions for Use - 14 - Instructions for Use Vista 120 Patient Monitor Vista 120 configuration Size (L×W×H) Shape Function Configuration 408 mm × 157 mm × 316 mm Square ECG, RESP, SpO2, NIBP, TEMP, IBP, CO2 - 15 - Instructions for Use Vista 120 Patient Monitor Getting started Initial inspection Before unpacking, check the packaging and check that there are no signs of mishandling or damage. If the shipping cartons are damaged, contact your local supplier for assistance. Open the package carefully and remove the monitor and accessories. Check that all correct options and accessories are included. If you have any question, contact your local supplier. Installing the monitor Installing the monitor on a flat surface Place the monitor on a flat surface. Make sure the surface does not vibrate and is free of corrosive medicine and dust. Installing the monitor on a wall Refer to Wall-Mounting Bracket Assembly Instruction. Installing the monitor on a roll stand/trolley An Assembling Instruction will be delivered with the roll stand/trolley. Refer to that Assembly Instruction for details of installing the monitor on a roll stand/trolley. Connecting the power cord 1. Make sure the AC power supply complies with the following specifications: 100 V to 240 V~, 50 Hz/60 Hz. 2. Connect the power cord provided with the monitor to the power input of the monitor. Connect the other end of the power cord to a grounded 3-phase power output. Checking the monitor Make sure there is no damage to the measurement accessories and cables. Turn on the monitor and verify that the monitor starts normally. Make sure all alarm lamps light up and the alarm sound is heard when turning on the monitor. WARNING Do not use the device if you detect any damage or if the monitor displays error messages. Contact your hospital technical personnel or Customer Service Center immediately. - 16 - Instructions for Use Vista 120 Patient Monitor NOTE • Check that all monitor functions are operating correctly. • If rechargeable batteries were provided, charge them each time before using the device to ensure adequate power. • If you power the monitor off, wait at least 60 seconds before powering it on again. Checking the strip recorder If your monitor is equipped with a strip recorder, verify that paper is properly installed in the strip recorder by opening the strip recorder’s door. Refer to the chapter “Recording” for details regarding installing paper. Setting the date and time To set the date and time: 1. Select Menu > System Setup > Date Time Setup. 2. Adjust the date display format as desired. 3. Set the correct time of Year, Month, Day, Hour, Min and Sec from the pop-up menu and press Exit. - 17 - Instructions for Use Vista 120 Patient Monitor System Configuration The user can not change the system configuration of the monitor. After the monitor is installed and checked properly, a service engineer needs to change the system configuration. Opening User Maintain Menu 1. Select the Menu item on the main interface. 2. Select Maintenance > User Maintain 3. Type the password into the displayed dialog box and press OK to enter the User Maintain menu. Entering Demo Mode WARNING The Demo Mode is for demonstration purposes only. You must not change to Demo Mode during patient monitoring. In Demo Mode, all stored trend information is deleted from the monitor’s memory. To change from operating mode to demo mode: 1. Select Menu > Common Function > Demo Mode from the pop-up dialog box. 2. Type the password into the displayed dialog box. After entering the Demo Mode, the monitor will perform the following: • Stops detecting alarms and generating alarm signals. • Stops storing data and clears previously stored data from memory. • All real-time data and historical data are simulated rather than actual patient data. To exit the Demo Mode, select Menu > Common Function > Demo Mode Selecting Lead Placement ECG lead names have two styles: American standard (AHA) and European standard (EURO). To set the correct style: 1. Select User Maintain > Lead Placement 2. Select AHA or EURO from the list and press the knob to confirm the selection. - 18 - Instructions for Use Vista 120 Patient Monitor Operation Everything the user needs to operate the monitor is displayed on its screen. Nearly every element on the screen is interactive. Screen elements include measurement numerics, waveforms, screen keys, information fields, alarms fields and menus. The monitor can be configured in a number of different ways. For example, the user can access an item through the on-screen setup menu, via a hard key, or via a shortcut key. This Instructions for Use describes how to access items via an on-screen menu. 1 2 3 4 5 6 16 7 15 14 1 2 3 4 5 6 7 8 9 12 11 13 Department Bed number Patient name Patient type Alarm status area Alarm off Measurement value Menu Scroll right to display more shortcut keys 10 11 12 13 14 15 16 - 19 - 10 9 8 Date and time Battery status symbol AC power supply symbol Shortcut key area Scroll left to display more shortcut keys Mute key Parameter waveform Instructions for Use Vista 120 Patient Monitor Using keys The monitor has four different types of keys: Permanent keys A permanent key is a graphical key that is permanently located at the bottom of the main screen allowing fast, direct access to functions. Menu Display the main setup menu Mute Permanently silences auditory alarm signals Shortcut keys A shortcut key is a configurable graphical key located at the bottom of the main screen. It gives the user direct access to functions. The selection of shortcut keys available on the monitor depends on the monitor configuration and options purchased. The following functions are available: Admission Admit a patient Trend Graph Access the trend graph review dialog box Trend Table Access the trend table review dialog box AlarmReview Access the alarm event review dialog box NIBP Review Access the NIBP review dialog box ARR Review Access the ARR review dialog box Standard Access the standard dialog box TrendScreen Access the Trend Screen dialog box OxyCRG Access the OxyCRG dialog box Large Font Access the Large Font dialog box ModulSwitch Access the module switch dialog box Key Volume Change the key volume - 20 - Instructions for Use Vista 120 Patient Monitor Brightness Adjust the screen brightness Touch Calib Calibrate the touch screen IBP Zero Zero the IBP sensor Alarm Setup Access the alarm setup dialog box Beat Volume Change the beat volume Menu Enter the menu Mute Mute the alarm Standby Standby mode Hardkeys Hardkeys are the physical keys on the front panel of the monitor. The Vista 120 has the following hardkeys: Mute, NIBP, Trend, Freeze, Recording, and Menu. Refer also to the chapter “Front view”. Pop-up keys Pop-up keys are task-related graphical keys that appear automatically on the screen when required. For example, the confirmation pop-up key appears only when the user need to confirm a change. Changing monitor settings Adjusting screen brightness To change the screen brightness: 1. Press the Brightness key on the screen directly or. 2. Select Menu > Common Function > Brightness, and select the appropriate setting for the screen brightness. 10 is the brightest, 1 is the least bright. The monitor can be configured with lower brightness in standby mode and also for transport to conserve battery power. - 21 - Instructions for Use Vista 120 Patient Monitor Changing date and time To change the date and time, refer to chapter “Setting the date and time”. WARNING Changing date and time will affect the storage of trend data. Adjusting volume Adjusting key volume The key volume is audible when the user selects any field on the monitor screen or when the user turns the knob. To adjust the key volume: 1. Select the Key Volume key on the screen directly or 2. Select Menu > System Setup > Key Volume, then select the appropriate setting: Five is the loudest and Zero is the quietest. Adjusting alarm volume The monitor provides five levels of alarm volume: 1, 2, 3, 4 and 5. To change the alarm volume: 1. Select Menu > Alarm Setup > Alarm Volume, and select the desired setting from the pop-up dialog box. Adjusting beat volume To change the beat volume, press the Beat Volume key on the screen directly or refer to chapter “Adjusting beat volume”. Checking the monitor version To check the monitor version, select Menu > Common Function > About to check the monitor revision menu. Setting languages To change the language: 1. Select Menu > Maintenance > User Maintain, then type the maintenance password into the displayed dialog box. 2. Select the Language option on the pop-up dialog box to display the language list. 3. Select the desired language from the list. To make the change permanent, restart the monitor. - 22 - Instructions for Use Vista 120 Patient Monitor Understanding screens The monitor has a set of preconfigured screens, which are optimized for common monitoring scenarios such as OR adult or ICU neonatal. A screen defines the overall selection, size and position of waveforms, numerics and shortcut keys displayed when the user starts the monitor. The user can switch between different screens during monitoring. Screens do not affect alarm settings, patient category etc. If the user changes from a complex to a less complex screen layout, some measurements may not be visible but are still monitored in the background. For detailed information, refer to chapter “User Interface”. Calibrating screens To calibrate the screen: 1. Select the Touch Calib shortcut key on the screen directly or select Menu > Maintenance > User Maintain, then type the maintenance password into the displayed dialog box, then select TouchScr Calibration from the pop-up dialog box. 2. The symbol appears on the screen. 3. Click the center of the symbol . 4. After calibration, the message Screen Calibration completed appears on the screen. Select Exit to finish the calibration. - 23 - Instructions for Use Vista 120 Patient Monitor Alarms The following alarm information is applicable for all measurements. Refer to chapters on specific alarms for more information. WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in different areas, e.g., an intensive care unit or an cardiac operating room. Alarm category The monitor has physiological, technical, and prompt alarms. Physiological alarms If one or more physiological parameters monitoring the patient exceed the predefined alarm limit (for example: APNEA and SpO2 value exceed the alarm limit), the monitor alarms. For more information, refer to chapter “Physiological alarm information”. Technical alarms If, for example, the device has a low battery or defective lead the monitor will initiate a technical alarm. Technical alarms cannot be disabled. For more information, refer to chapter “Technical Alarm Information”. Prompts The device monitors processes and other functions, such as: ARR Relearning. For more information, refer to chapter “Prompts”. Alarm levels There are three alarm levels consisting of high, medium, and low. 1. High level alarms A life threatening situation exists and emergency treatment is required. 2. Medium level alarms The patient’s vital signs or system status is abnormal. Response is required. 3. Low level alarms The patient’s vital signs or system status is abnormal. Attention is required. - 24 - Instructions for Use Vista 120 Patient Monitor Alarm sound The high/medium/low-level alarms have the following audible characteristics: Alarm level High Medium Low Prompt Mode is “DO-DO-DO------DO-DO, DO-DO-DO------DO-DO”, which is triggered once every 5 seconds. The alarm indicator flashes in red, with a frequency of 1.4Hz~2.8Hz. Mode is “DO-DO-DO”, which is triggered once every 25 seconds. The alarm indicator flashes in yellow, with a frequency of 0.4Hz~0.8Hz. Mode is “DO-”, which is triggered once every 30 seconds. The sound pressure range for audible alarm signals is from 45 dB to 85 dB. Controlling alarm Switching the individual alarm off To switch the alarm off, select XX Setup > Alarm Setup (XX stands for parameter name) and set the alarm from the pop-up list. Temporary alarm mute If the monitor is in temporary alarm mute status, the monitor will: • Not generate an auditory alarm signal. • Visually display alarm information. The temporary alarm mute symbol a red colored background. is displayed and the remaining pause time is displayed on The user can set the audio pause to 60 s, 120 s, or 180 s. Alarm mute To mute the alarm, select Menu > Maintenance > User Maintain > Alarm Setup, and set Mute to On. Press the key on the front panel for more than three seconds or the shortcut key Mute on the screen to mute the alarm. Setting alarm limits WARNING Prior to monitoring, make sure that the alarm limit settings are appropriate for your patient. - 25 - Instructions for Use Vista 120 Patient Monitor WARNING Setting alarm limits to extreme values may cause the alarm system to become ineffective. To change individual measurement alarm limits: 1. Select the HR Parameter area. 2. Select HR Setup > Alarm Setup. Then set the alarm limit to the desired value from the pop-up dialog box. See the following figure: High Alarm Limit Upper arrow or lower arrow to increase or decrease the alarm limit Setting value of high alarm limit Setting value of low alarm limit Low Alarm Limit Latching alarms To set the alarm latch function, select Menu > Maintenance > User Maintain > Alarm Setup and set Alarm Latch from the pull-down list. If set to On, when an alarm occurs, the monitor will display the alarm message of the parameter in the alarm status area. If several parameters latch alarms, each message is displayed in two second intervals. To deselect the alarm latch, set Alarm Latch to Off. When Alarm Latch is set to Off, the latch function is invalid. Testing alarms When the user switches the monitor on, a self test is started. Verify that the alarm indicator lights and emits a single tone. The self test verifies that the visible and audible alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on a subject or use a simulator. If necessary, adjust the alarm limits and check that the system is operating correctly. - 26 - Instructions for Use Vista 120 Patient Monitor Alarm information Physiological alarm information Message Cause Alarm level ECG Too Weak Cannot detect the signal in designated time period. High ST-X high ST value is above the upper alarm limit. (X stands for I, II, III, aVR, aVL, aVF, V) User-selectable ST-X low ST value is below the lower alarm limit. (X stands for I, II, III, aVR, aVL, aVF, V) User-selectable ASYSTOLE No QRS is detected for 4 consecutive seconds User-selectable VFIB/VTAC Ventricular tachycardia: The fibrillation waveform lasts for 4 consecutive seconds; or the number of continuous Vent beats is larger than the upper limit of cluster Vent beats (>5). The RR interval is less than 600 ms. User-selectable VT>2 3< the number of cluster PVCs < 5 User-selectable COUPLET 2 consecutive PVCs User-selectable BIGEMINY Vent bigeminy User-selectable TRIGEMINY Vent trigeminy User-selectable R ON T A type of single PVC under the condition that HR<100, R-R interval is less than 1/3 the average interval, followed by a compensating pause of 1.25X the average R-R interval (the next R wave advances onto the previous T wave). User-selectable PVC Single PVCs not belonging to the type of above mentioned PVCs. User-selectable TACHY 5 consecutive QRS complex, RR interval is less than 0.5 s. User-selectable BRADY 5 consecutive QRS complex, RR interval is longer than 1.5 s. User-selectable MISSED BEATS When HR is less than 100 beats/min., no heart beat is detected during the period 1.75 times of the average RR interval; or User-selectable When HR is higher than 100beat/min, no beat is detected within 1 second. IRR IRREGULAR RHYTHM: The patient has irregular heart rate, check patient’s condition, electrodes, cables and leads. - 27 - User-selectable Instructions for Use Vista 120 Patient Monitor Message Cause Alarm level PNC PACE NOT CAPTURE: After the pacemaker is paced, QRS complex can not be detected during 300 ms. User-selectable PNP PACER NOT PACED: After the QRS complex, no pace is detected during 1.75 times of RR interval. User-selectable VBRADY VENTRICULAR BRADYCARDIA: The patient has irregular HR, and his average HR is less than 60 bpm. Check his condition, electrodes, cables and leads. User-selectable VENT VENTRICULAR RHYTHM: The patient has irregular heart rate, check patient’s condition, electrodes, cables and leads. User-selectable RESP APNEA RESP cannot be measured within specific time interval. High RR High RESP value is above upper alarm limit. User-selectable RR Low RESP value is below lower alarm limit. User-selectable HR High HR value is above the upper alarm limit. User-selectable HR Low HR value is below the lower alarm limit. User-selectable SpO2 High SpO2 value is above upper alarm limit. User-selectable SpO2 Low SpO2 value is below lower alarm limit. User-selectable SpO2 No Pulse The signal of the measurement site is too weak, so the monitor can not detect the pulse signal. High PR High PR value is above upper alarm limit. User-selectable PR Low PR value is below lower alarm limit. User-selectable T1 High Value of T1 channel is above upper alarm limit. User-selectable T1 low Value of T1 channel is below lower alarm limit. User-selectable T2 High Value of T2 channel is above upper alarm limit. User-selectable T2 Low Value of T2 channel is below lower alarm limit. User-selectable TD High Value of TD channel is above upper alarm limit. User-selectable TEMP High Value of TEMP is above upper alarm limit. User-selectable TEMP Low Value of TEMP is below lower alarm limit. User-selectable SYS High SYS value is above upper alarm limit. User-selectable SYS Low SYS value is below lower alarm limit. User-selectable DIA High DIA value is above upper alarm limit. User-selectable DIA Low DIA value is below lower alarm limit. User-selectable MAP High MAP value is above upper alarm limit. User-selectable - 28 - Instructions for Use Vista 120 Patient Monitor Message Cause Alarm level MAP Low MAP value is below lower alarm limit. User-selectable Art SYS High Art SYS value is above upper alarm limit. User-selectable Art SYS Low Art SYS value is below lower alarm limit. User-selectable Art DIA High Art DIA value is above upper alarm limit. User-selectable Art DIA Low Art DIA value is below lower alarm limit. User-selectable Art MAP High Art MAP value is above upper alarm limit. User-selectable Art MAP Low Art MAP value is below lower alarm limit. User-selectable PA SYS High PA SYS value is above upper alarm limit. User-selectable PA SYS Low PA SYS value is below lower alarm limit. User-selectable PA DIA High PA DIA value is above upper alarm limit. User-selectable PA DIA Low PA DIA value is below lower alarm limit. User-selectable PA MAP High PA MAP value is above upper alarm limit. User-selectable PA MAP Low PA MAP value is below lower alarm limit. User-selectable CVP MAP High CVP MAP value is above upper alarm limit. User-selectable CVP MAP Low CVP MAP value is below lower alarm limit. User-selectable ICP MAP High ICP MAP value is above upper alarm limit. User-selectable ICP MAP Low ICP MAP value is below lower alarm limit. User-selectable LAP MAP High LAP MAP value is above upper alarm limit. User-selectable LAP MAP Low LAP MAP value is below lower alarm limit. User-selectable RAP MAP High RAP MAP value is above upper alarm limit. User-selectable RAP MAP Low RAP MAP value is below lower alarm limit. User-selectable P1 SYS High P1 SYS value is above upper alarm limit. User-selectable P1 SYS Low P1 SYS value is below lower alarm limit. User-selectable P1 DIA High P1 DIA value is above upper alarm limit. User-selectable P1 DIA Low P1 DIA value is below lower alarm limit. User-selectable P1 MAP High P1 MAP value is above upper alarm limit. User-selectable P1 MAP Low P1 MAP value is below lower alarm limit. User-selectable P2 SYS High P2 SYS value is above upper alarm limit. User-selectable P2 SYS Low P2 SYS value is below lower alarm limit. User-selectable P2 DIA High P2 DIA value is above upper alarm limit. User-selectable P2 DIA Low P2 DIA value is below lower alarm limit. User-selectable - 29 - Instructions for Use Vista 120 Patient Monitor Message Cause Alarm level P2 MAP High P2 MAP value is above upper alarm limit. User-selectable P2 MAP Low P2 MAP value is below lower alarm limit. User-selectable EtCO2 High EtCO2 value is above upper alarm limit. User-selectable EtCO2 Low EtCO2 value is below lower alarm limit. User-selectable FiCO2 High FiCO2 value is above alarm limits. User-selectable AWRR High AwRR value is above upper alarm limit. User-selectable AWRR Low AwRR value is below lower alarm limit. User-selectable CO2 APNEA In a specific time interval, no RESP were detected by the CO2 module. High Technical alarm information NOTE The lead names in the table below use the AHA (American Heart Association) denomination. For the corresponding IEC lead names, refer to chapter “Installing Electrodes”. Message Cause Alarm Level Action Taken ECG Lead Off More than one ECG electrode is off the skin or ECG cable is disconnected from the monitor. Low Make sure that all electrodes, lead wires and patient cables are properly connected. ECG V Lead Off ECG electrode V is off the skin or that lead wire is disconnected. Low ECG LL Lead Off ECG electrode LL is off the skin or that lead wire is disconnected. Low ECG LA Lead Off ECG electrode LA is off the skin or that lead wire is disconnected. Low ECG RL Lead Off ECG electrode RL is off the skin or that lead wire is disconnected. Low ECG RA Lead Off ECG electrode RA is off the skin or that lead wire is disconnected. Low - 30 - Instructions for Use Vista 120 Patient Monitor Message Cause Alarm Level Action Taken ECG Signal Exceed ECG value is beyond measuring range. High Check lead connection and patient condition ECG Comm Fail ECG module failure or communication failure High ECG Noise ECG signal is too noisy. Low Stop monitoring ECG and notify hospital technical personnel or customer support. Check lead connection and patient condition ECG Signal Overflow The amplitude of ECG is too tall. Low Modify the ECG gain. RESP Comm Fail RESP module failure or communication failure High SpO2 Sensor Off SpO2 sensor may be disconnected from the patient or the monitor. Low Stop monitoring RESP, and notify hospital technical personnel or customer support. Ensure the sensor is properly connected to the patient’s body. SpO2 No Sensor SpO2 sensor was not connected well or connected to the monitor, or the connection is loose. Low Ensure the monitor and sensor are properly connected. Reconnect the sensor. SpO2 Low Perfusion The pulse signal is too weak or the perfusion of the measurement site is too low. Low Reconnect the SpO2 sensor and change the measurement site. If the problem continues, notify hospital technical personnel or customer support. SpO2 Comm Fail SpO2 module failure or communication failure High NIBP Comm Fail NIBP module failure or communication failure High Stop monitoring SpO2 and notify hospital technical personnel or customer support Stop monitoring NIBP and notify hospital technical personnel or customer support - 31 - Instructions for Use Vista 120 Patient Monitor Message Cause Alarm Level Action Taken NIBP Loose Cuff Cuff is no properly wrapped or no cuff exists Low Rewrap the cuff NIBP Weak Signal Cuff is too loose or patient pulse is too weak. Low Use a different method to measure blood pressure. NIBP Excessive Motion Due to arm motion, signal noise is too large or pulse rate is not regular Low Ensure that the patient being monitored is still. NIBP Excessive Pressure Pressure has exceeded the specified upper safety limit Low Measure again, if failure persists, stop monitoring NIBP and notify hospital technical personnel or customer support. NIBP Signal Saturated Signal amplitude too strong Low Stop the patient from moving. NIBP Init Pressure High The initial pressure is too high during measuring High Measure again, if failure persists, stop monitoring NIBP and notify hospital technical personnel or customer support. NIBP Invalid Reset The hardware pressure is too high Low Measure again, if failure persists, stop monitoring NIBP and notify hospital technical personnel or customer support. NIBP Time Out Measuring time has exceeded 120 seconds (adult/pediatric) or 90 seconds (neonatal). Low Measure again or use other measuring method. NIBP Tube Leak NIBP cuff or pump has a leakage Low Check the NIBP cuff and pump for leakages NIBP Cuff type Error The cuff type used is inconsistent with the patient type Low Confirm the patient type and change the cuff - 32 - Instructions for Use Vista 120 Patient Monitor Message Cause Alarm Level Action Taken Air Pressure Error Environment atmospheric pressure abnormal or system pressure abnormal Low Check whether the airway is occluded or pressure sensor works properly in pressure meter mode. If the problem still exists, contact your service personnel. NIBP Self Test Error Sensor or other hardware errors High Contact your service personnel. NIBP Pneumatic Leak NIBP cuff or pump has a leakge Low Check the NIBP cuff and pump for leakages NIBP System Failure Hardware abnormal High Contact your service personnel. NIBP Cuff Leak Cuff, pumnp or airway has a leakage Low NIBP cuff is not properly connected, or there is a leak in the airway. NIBP Leak Test Error Hardware abnormal High Check whether the airway is occluded or pressure sensor works properly in pressure meter mode. If the problem still exists, contact your service personnel. NIBP Range Exceeded The patient’s blood pressure is beyond the measurement range Low The patient’s blood pressure is beyond the measurement range NIBP Air Leak The cuff pressure cannot reach the set value within 60 sec. or 20 sec. Neo mode Low Check the connections and the wrapped cuff to see whether they are all well prepared. - 33 - Instructions for Use Vista 120 Patient Monitor Message Cause Alarm Level Action Taken NIBP Pressure Low The module is unable to detect the SYSTOLIC. Measure the pressure again. Low Inflate gain and retry three times. Check whether the patient has an overly high blood pressure or it is interfered by movement. NIBP Pulse Abnormal Abnormal oscillometric waveform Low Retry twice. Check for hyperkinesia or arrhythmia. NIBP Pulse Signal Weak Pulse is too low to measure Low Check the patient’s condition or the wrapped cuff. TEMP T1 Sensor Off Temperature cable of TEMP channel 1 may be disconnected. Low Make sure that the cable is properly connected TEMP T2 Sensor Off Temperature cable of TEMP channel 2 may be disconnected. Low Make sure that the cable is properly connected. Excessive T1 TEMP1 measuring value is beyond measuring range. High Check sensor connection and patient condition Excessive T2 TEMP2 measuring value is beyond measuring range. High TEMP Comm Fail TEMP module failure or communication failure High YY Sensor Off (YY stands for the IBP label name) IBP sensor falls off monitor. Low Check sensor connection and patient condition Stop monitoring TEMP and notify hospital technical personnel or customer support. Make sure that cable is properly connected. YY Comm Fail (YY stands for the label name) IBP module failure or communication failure High CO2 Out Of Range The CO2 concentration exceeds the accuracy range of the gas module High - 34 - Stop monitoring IBP and notify hospital technical personnel or customer support. Reduce CO2 concentration Instructions for Use Vista 120 Patient Monitor Message Cause Alarm Level Action Taken CO2 Sensor Faulty CO2 module failure High Stop monitoring CO2 and notify hospital technical personnel or customer support. CO2 Comm Fail CO2 module failure or communication failure High CO2 Ram Error CO2 module failure High CO2 Rom Error CO2 module failure High CO2 Zero Required Zero calibration failure Low CO2 Check Adapter The cannula is off or disconnected Low Battery Low Battery low High Change the battery or recharge it Recorder Out Of Paper Recorder out of paper Low Insert new paper Recorder setup needed The user presses the RECORD button when the monitor is not installed with a recorder. Low Notify hospital technical personnel or customer support to install and set the recorder. CO2 Sensor Over Temp Prompts Message Cause ECG Arr Learning The QRS template building required for Arr. Analysis is in process. SpO2 Search Pulse When the sensor is connected to the patient, the SpO2 is analyzing the patient signal and searching for the pulse to compute the saturation. Manual Measuring In manual measuring mode Continual Measuring In continuous measuring mode Auto Measuring In automatic measuring mode - 35 - Instructions for Use Vista 120 Patient Monitor Message Cause Measure Abort Measurement over Calibrating During calibrating Calibrate Abort Calibration over Leak Testing During pneumatic test Leak Test Ok NIBP module has passed leak test Leak Test Abort Pneumatic test over Resetting NIBP module in resetting Please Start NIBP module is in idle status Done NIBP measurement successfully done Continual Measuring NIBP module performs continuous measuring Stat Measuring NIBP module performs STAT measurement Please Switch To Maintain Mode NIBP module is in normal mode, the user can not start leak test and pressure calibration. Enter User Maintain > NIBP Maintain and switch to Maintain Mode to perform leak test or pressure calibration. Please Switch To Normal Mode NIBP module is in maintain mode, the user can not start blood pressure measurement. Enter User Maintain > NIBP Maintain and switch to Normal Mode to perform blood pressure measurement. CO2 Standby Changing from measuring to standby mode places the module in energy-saving status. CO2 Sensor Warm Up The CO2 module is in warm-up state. - 36 - Instructions for Use Vista 120 Patient Monitor Adjustable range of alarm limits ECG alarm limits are listed as follows (unit bpm): HR Patient Type ALM HI ALM LO ADU 300 15 PED 350 15 NEO 350 15 ST analysis alarm limits are listed as follows (unit mV): ST ALM HI ALM LO 2.0 -2.0 PVCs alarm upper limits are listed as follows: ALM HI PVCs ALM LO 10 RESP alarm limits are listed as follows (unit rpm): Patient Type ALM HI ALM LO ADU 120 6 PED 150 6 NEO 150 6 SpO2 alarm limits are listed as follows (unit %): SpO2 ALM HI ALM LO 100 0 PR alarm limit is listed as follows (unit bpm): PR ALM HI ALM LO 300 30 NIBP alarm limits are listed as follows (unit mmHg): Patient Type ADU ALM HI ALM LO SYS 270 40 DIA 215 10 - 37 - Instructions for Use Vista 120 Patient Monitor PED NEO MAP 235 20 SYS 200 40 DIA 150 10 MAP 165 20 SYS 135 40 DIA 100 10 MAP 110 20 TEMP alarm limits are listed as follows: ALM HI ALM LO T1 50 °C (122 °F) 0 °C (32 °F) T2 50 °C (122 °F) 0 °C (32 °F) TD 50 °C (90 °F) 0 °C (0 °F) IBP alarm limits are listed as follows (unit mmHg): ALM HI ALM LO Art 300 0 CVP 40 -10 ICP 40 -10 LAP 40 -10 P1 300 -50 P2 300 -50 PA 120 -6 RAP 40 -10 CO2 alarm limits are listed as follows: ALM HI ALM LO EtCO2 150 mmHg 0 FiCO2 50 mmHg 3 mmHg AwRR 150 rpm 2 rpm - 38 - Instructions for Use Vista 120 Patient Monitor Managing patients Admitting a patient The monitor displays patient physiological data and records the information in trends. This allows the user to monitor unadmitted patients. It is recommended, however, that the user admit patients to record their information in reports. During admission, the patient category setting determines the algorithm that the monitor uses to process and calculate measurements. These include safety limits that are applied for specific measurements and alarm limit ranges. To admit a patient: 1. Select the Admission shortcut key on the screen or 2. Select Menu > Patient Setup > New Patient, then a message is displayed to ask the user to confirm to update patient. 3. Click No to cancel this operation; click Yes, the Patient Info window is displayed. 4. Enter the patient information: • Serial No: Enter the patient’s medical record number (MRN), for example 12345678. • Last name: Enter the patient’s last name (family name), for example Smith. • First name: Enter the patient’s first name, for example Joseph. • Gender: Choose Male or Female. • Type: Choose the patient type, either Adult, Pediat, or Neonat. • BloodType: Choose the patient type N/A, A, B, AB, or O. • Pace: Choose On or Off (The user must use On if the patient has a pacemaker). • Date of Birth: Enter the patient’s date of birth. • Date of Admission: Enter the patient’s date of admission. • Height: Enter the patient’s height. • Weight: Enter the patient’s weight. • Doctor: Enter any extra information about the patient or treatment. 5. Select Exit to save the changes and exit this screen. Patient category and paced status The patient category setting determines which algorithm the monitor uses for specific measurements, the safety limits that are applied for specific measurements, and the alarm limit range. The paced setting determines whether the monitor shows pacemaker pulses. When Pace is set to Off, pace pulses are filtered and do not show in the ECG waveform. Refer to chapter “Setting Pace Status”. - 39 - Instructions for Use Vista 120 Patient Monitor WARNING Changing the patient category may change the arrhythmia and NIBP alarm limits. Always check alarm limits to make sure that they are appropriate for your patient. WARNING For paced patients, you must set Pace to On. If it is incorrectly set to Off, the monitor could mistake a pace pulse for a QRS and fail to alarm during asystole. Quick admit If the user does not have the time or information to fully admit a patient, fill in the rest of the patient information later. The user can quickly admit a patient as follows: 1. Select Menu > Patient Setup > Quick Admit, a message is displayed requesting that the user confirm the patient update. 2. Click No to cancel this operation; click Yes to continue and the Patient Info window is displayed, choose Type and Pace and set them to the correct mode. 3. Select Exit to save the changes and exit this screen. Editing patient information To edit the patient information after a patient has been admitted, select Menu > Patient Setup > Patient Info, and make the desired changes through the pop-up dialog box. Update a patient The user should always perform an update before starting monitoring for a new patient. To update a patient: • Select Menu > Patient Setup > New Patient or Menu > Patient Setup > Quick Admit, a menu is displayed. • If the user selects Yes, the monitor will update the patient information. • If the user selects No, the monitor won’t update the patient information and returns to patient setup dialog box. NOTE Discharging a patient will clear all associated data in the monitor. - 40 - Instructions for Use Vista 120 Patient Monitor User interface Setting interface style The user can set the interface style. The following options are available: • Waveform sweep • Monitored parameters Only authorized personnel should set the interface style. Selecting display parameters The user can select the display parameters based on specific monitoring and measurement requirements. To select the parameter: 1. Select Menu > System Setup > Module Switch. 2. Select the parameters from the pop-up dialog box. 3. Press Exit to exit the menu. The screen will adjust the parameters automatically. Changing waveform position The user can exchange the waveform positions of parameter A and parameter B as follows: 1. Select waveform A and display the setup menu of waveform A. 2. Select Change from the pop-up menu and select the desired label name of waveform B from the pull-down list. Changing interface layout To change the interface layout: 1. Select Menu > Display Setting. 2. Select one dialog box from the pop-up menu. 3. The user can implement one kind of function screen based on the requirements. If the user selects the Large Font option, there is no function screen to be selected. Viewing short trend screen To view the short trend screen, press the Trend Screen key on the screen directly or select Menu > Display Setting > View Selection > TrendScreen. Viewing OxyCRG screen To view the oxyCRG screen, press the OxyCRG key on the screen or select Menu > Display Setting > View Selection > OxyCRG. - 41 - Instructions for Use Vista 120 Patient Monitor This is a NICU only feature. Monitoring of SpO2, HR and Resp is different for neonates than for adults. Viewing large font screen To display the large font screen: 1. Select the Large Font key on the screen directly or. 2. Select Menu > Display Setting > View Selection > Large Font to select this display mode. To view the large font dialog box of specific parameter, select the parameter pull-down dialog on the dialog box (the red rectangle shown in the following figure). - 42 - Instructions for Use Vista 120 Patient Monitor Monitoring ECG Overview The electrocardiogram (ECG) measures electrical activity in the heart and displays it both numerically and as a waveform. This chapter also describes arrhythmia and ST segment monitoring. ECG safety information WARNING Do not touch the patient, table, or the monitor during defibrillation. WARNING Use only compatible ECG cables for monitoring. WARNING When connecting the cables and electrodes, make sure no conductive part is in contact with the ground. Verify that all ECG electrodes, including the neutral electrode, are securely attached to the patient but not a conductive part or ground. WARNING Check every day whether there is skin irritation resulted from the ECG electrodes. If yes, replace electrodes every 24 hours or change their sites. WARNING Place the electrode carefully and ensure a good contact. WARNING Check if the lead connection is correct before monitoring. If you unplug the ECG cable from the socket, the screen will display the error message “ECG LEAD OFF” and an audible alarm sounds. WARNING When using the monitor with the defibrillator or other high-frequency equipment, use defibrillator-proof ECG leads to avoid burns. WARNING When using electrosurgery (ES) equipment, do not place an electrode near the grounding plate of the electrosurgery device: otherwise, more interference will be evident on the ECG waveform. WARNING For paced patients, you must set Pace to On. If it is incorrectly set to Off, the monitor could mistake a pace pulse for a QRS and fail to alarm during asystole. WARNING The simultaneous use of cardiac pacemaker and other patient-connected equipment may cause a safety hazard. - 43 - Instructions for Use Vista 120 Patient Monitor CAUTION If patients may be defibrillated, be sure to use defibrillation-proof ECG cables, otherwise, the ECG cables will be damaged. NOTE • Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform. • IEC/EN60601-1-2 (protection against radiation is 3 V/m) specifies that the electrical field density exceeding 1V/m may cause measurement error in various frequencies. It is accordingly suggested to not use equipment generating electrical radiation near ECG/RESP monitoring devices. • In the default settings of the monitor, the ECG waveforms are the first two waveforms from the top in the waveform area. • For measurements in or near the heart connect the monitor to the potential equalization system. • For protecting the environment, the used electrodes must be recycled or disposed of properly. ECG display The figure below is for reference only. The symbol “①” indicates the lead name of the displayed waveform; refer to chapter “Selecting calculation lead”. The symbol “②” indicates waveform gain; refer to chapter “Changing the size of the ECG waveform”. The symbol “③” indicates Filter setting; refer to chapter “Changing the ECG filter setting”. Changing the size of the ECG waveform If any of the displayed ECG waveforms are too small or clipped, the size can be changed. Select ECG Waveform Setup > ECG Gain, then select an appropriate factor from the pop-up box to adjust the ECG waveform. X0.125 to make strength of ECG signal waveform of 1 mV become 1.25 mm; - 44 - Instructions for Use Vista 120 Patient Monitor X0.25 to make strength of ECG signal waveform of 1 mV become 2.5 mm; X0.5 to make strength of ECG signal waveform of 1 mV become 5 mm; X1 to make strength of ECG signal waveform of 1 mV become 10 mm; X2 to make strength of ECG signal waveform of 1 mV become 20 mm; Auto let the monitor choose the optimal adjustment factor for all the ECG waveforms. Changing the ECG filter settings The ECG filter setting defines how ECG waveforms are smoothed. An abbreviation indicating the filter type is shown under the lead label on the monitor display. Filter settings do not affect ST measurement. To change the filter setting in the ECG Setup menu, select Filter and then select the appropriate setting. • Monitor: Use this mode under normal measurement conditions. • Surgery: The filter reduces interference to the signal. It should be used if the signal is distorted by high- or low-frequency interference. High frequency interference usually results in large amplitude spikes making the ECG signal look irregular. Low-frequency interference usually leads to a wandering or rough baseline. In the operating room, the Filter reduces artifacts and interference from HF surgical equipment. Under normal measurement conditions, selecting Surgery may distort the QRS complexes too much and thus interfere with the clinical evaluation of the ECG displayed on the monitor. • Diagnos: Use when diagnostic quality is required. The unfiltered ECG waveform is displayed so that changes such as R-wave notching or discrete elevation or depression of the ST segments are visible. Using ECG alarms ECG alarms can be switched on and off. Changes to high and low alarm limits can be made using the same methods used in other measurement alarms. Refer to chapter “Alarms” for more information. Only ECG special alarm features are described in this chapter. Selecting calculation lead On the Normal dialog box, the user can select either 3 LEADS or 5 LEADS for this item. Normal QRS complex is defined as: • The normal QRS should be either completely above or below the baseline and it should not be biphasic. For paced patients, the QRS complexes should be at least twice the height of pace pulses. • The QRS should be tall and narrow. • The P-waves and the T-waves should be less than 0.2 mV. - 45 - Instructions for Use Vista 120 Patient Monitor Monitoring procedure Preparation Skin is a poor conductor of electricity. Prepare the patient's skin to facilitate good electrode conductivity. • Select sites with intact skin, without impairment of any kind. • Shave hair from sites, if necessary. • Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, because this increases skin impedance). • Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease. Connecting ECG cables 1. Attach a clip or snap to the electrodes prior to placement. 2. Place the electrodes on the patient. Before attaching, apply some conductive jelly on the electrodes if the electrodes are not electrolyte self-supplied. 3. Connect the electrode lead to the patient's cable. Selecting lead type To change the lead type: 1. Select the ECG parameter area, display the ECG Setup menu; 2. Set Lead Type to 3 Leads or 5 Leads based on the lead used. Installing electrodes NOTE The following table gives the corresponding lead names according to IEC (used in Europe) and the AHA (USA) respectively. AHA (American Standard) Electrode Color Labels White RA IEC (Europe Standard) Electrode Labels Color R Red LA Black L Yellow LL Red F Green RL Green N Black V Brown C White - 46 - Instructions for Use Vista 120 Patient Monitor Electrode placement for 3-lead For the AHA standard for example, see the following figure: • RA: directly below the clavicle and near the right shoulder. • LA: directly below the clavicle and near the left shoulder. • LL: on the left hypogastrium. Electrode Placement for 3-lead Electrode placement for 5-lead For the AHA standard for example, see the following figure: • RA: directly below the clavicle and near the right shoulder. • LA: directly below the clavicle and near the left shoulder. • RL: on the right hypogastrium. • LL: on the left hypogastrium. • V: on the chest, the position depends on the desired lead selection. - 47 - Instructions for Use Vista 120 Patient Monitor Electrode Placement for 5-lead NOTE To ensure safety, all leads must be attached to the patient. For 5-lead, attach the V electrode to one of the indicated positions as below: • V1 On the 4th intercostal space at the right sterna margin. • V2 On the 4th intercostal space at the left sterna margin. • V3 Midway between V2 and V4 electrodes. • V4 On the 5th intercostal space at the left clavicular line. • V5 On the left anterior axillary line, horizontal with V4 electrode. • V6 On the left middle axillary line, horizontal with V4 electrode. • V3R-V6R On the right side of the chest in positions corresponding to those on the left. • VE Over the xiphoid position. • V7 On the 5th intercostal space at the left posterior axillary line of back. • V7R On the 5th intercostal space at the right posterior axillary line of back. - 48 - Instructions for Use Vista 120 Patient Monitor V-Electrode Placement for 5-lead Recommended ECG lead placement for surgical patients WARNING When using HF surgical equipment, leads should be placed in a position in equal distance from the cautery knife and the electrosurgery grounding plate to avoid burning the patient. HF surgical equipment wires and ECG cable must not be tangled up. ECG leads are used mainly for monitoring patient vital signs. When using the patient monitor with other HF surgical equipment, use defibrillator-proof ECG leads. The placement of the ECG leads depends on the type of surgery. For example, during open heart surgery the electrodes can be placed laterally on the chest or back. In the operating room, artifacts may affect the ECG waveform due to the use of ES (electrosurgery) equipment. To help reduce this interference, the electrodes can be placed on the right and left shoulders, the right and left sides near the abdomen and the chest lead on the left side at mid-chest. Avoid placing the electrodes on the upper arms, which might result in a small waveform. NOTE • If an ECG waveform is not accurate (with electrodes are tightly attached), change the lead. • Interference from a non-grounded instrument near the patient can cause inaccurate waveforms. - 49 - Instructions for Use Vista 120 Patient Monitor ECG menu setup Setting alarm source To change the alarm source, select ECG Setup > Alarm Source. Select from the following options: HR: HR is HR/PR alarm source; PR: PR is HR/PR alarm source; AUTO: If the Alarm Source is set to Auto, the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on. At least one ECG lead can be measured. The monitor will automatically switch to Pulse for the alarm source if: • a valid ECG lead can no longer be measured and • a Pulse source is switched on and available. The monitor uses the pulse rate from the currently active measurement as system pulse. While Pulse is the alarm source, all arrhythmia and ECG HR alarms are switched off. If an ECG lead becomes available again, the monitor automatically uses HR as alarm source. Smart lead off In 5 LEADS mode, if CH1 and CH2 are disabled due to lead off for example, the system selects other modes to collect an ECG waveform. To change the smart lead off setting, select ECG Setup > Smart Leadoff. Select options from the pop-up menu. Setting beat volume Beat volume is derived from HR or PR, depending on the HR alarm setting. To change the beat volume, select ECG Setup > Beat Volume, and select the desired volume from the pop-up menu. Six selections are available: 0, 1, 2, 3, 4, 5. 5 is maximum volume. 0 is mute. ECG display The ECG display varies with the Lead Type. When Lead Type is set to 3 Leads, Display can be set to Normal, and displays one ECG waveform on the main screen. When Lead Type is set to 5 Leads, Display can be set to Normal, Full-Scr and Half-Scr. Select Normal to display two ECG waveforms on the main screen. Select Full-Scr to display seven ECG waveforms. Half-Scr displays seven ECG waveforms on the screen in an area of four waveforms. NOTE If 3 Leads is selected in the ECG Setup menu, only Normal can be selected for Display in the sub-menu. - 50 - Instructions for Use Vista 120 Patient Monitor Setting pace status Set the paced status correctly when starting ECG monitoring. To change the paced status in the Setup ECG menu, select Pace to toggle between On or Off. When Pace is set to On: - Pace Pulse Rejection is switched on. This means that pacemaker pulses are not counted as extra QRS complexes. - Paced symbol is displayed as | on the main screen. NOTE • When monitoring a patient with a pacemaker, set Pace to On. If monitoring a patient without a pacemaker, set Pace to Off. • If Pace is set to On, the system will not perform some types of ARR analysis. WARNING Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Keep pacemaker patients under close observation. ECG calibration Selecting this item from the ECG Setup menu inserts a square wave into the ECG waveform that can be used to estimate the amplitude accuracy of that waveform. Select the item again to turn off the square wave. NOTE The patient is not monitored while this square wave is displayed. ECG waveform settings To change the speed, select ECG Wave Setup > Sweep, then select from the pop-up list. The bigger the value, the wider the waveform. ST segment monitoring The monitor performs ST segment analysis on normal and atrially paced beats and calculates ST segment elevations and depressions. This information can be displayed in the form of ST numerics and snippets on the monitor. ST segment monitoring function is shut off by default. It can be switched to On when necessary. When using the ST analysis function, the result is displayed on the main screen. Refer to the following figure. - 51 - Instructions for Use Vista 120 Patient Monitor Setting ST analysis To change ST analysis, select ECG Setup > ST Setup > ST Analysis, then select On or Off from the pop-up list. ST display The screen may look different from the illustrations. ST I 0.08 aVR -0.09 II 0.10 aVL 0.03 III 0.02 aVF 0.06 V 0.04 NOTE • ST Analysis can be used only in Adu mode. • If ST Analysis is on, the monitor must be in Diagnos mode. • ECG monitoring must be in Diagnos mode. ST analysis alarm setting The user can select Alarm > ST Alarm Setup > ST Setup to set the upper and lower alarm limit. ALM HI can be set to 0.2 to 2.0 mV, and ALM LO to -2.0 to +0.2 mV. ALM HI must be higher than ALM LO. About ST measurement points The ST value for each beat complex is the vertical difference between the isoelectric (ISO) point and the ST point, as shown in the diagram below. The ISO point provides the baseline, and the ST point is at the midpoint of the ST segment. The J point is where the QRS complex changes its slope. It is a fixed distance away from the ST point and can be useful during positioning. DEF POINT - 52 - Instructions for Use Vista 120 Patient Monitor The ST and ISO measurement points need to be adjusted when monitoring is started, and if the patient's heart rate or ECG morphology changes significantly. Always ensure that ST measurement points are appropriate for the patient. Abnormal QRS complexes are not considered in ST segment analysis. Adjusting ST and ISO measurement points Depending on the monitor’s configuration, the ST point can be positioned as well. These two points can be adjusted by turning the knob. When adjusting ST measurement point, the system shows the ST measurement point window. The system displays the QRS complex template in the window and can be adjusted using the highlight bar. The user can select ISO or ST by switching the knob left or right to move the cursor line. When the cursor is at the desired position, the base point or the measurement point can be selected. Arrhythmia monitoring Arrhythmia analysis The arrhythmia algorithm is used to monitor clinical neonatal and adult ECG. It also detects heart rate and ventricular rhythm changes, arrhythmia events, and generates alarm information. The arrhythmia algorithm can monitor paced and non-paced patients. Qualified personnel can use arrhythmia analysis to evaluate patient condition (such as heart rate, PVCs frequency, rhythm and ectopic beat). The arrhythmia algorithm can also monitor patients and generate arrhythmia specific alarms. The monitor can support up to 16 different arrhythmia analyses. ARR Types Occurring Condition ASYSTOLE No QRS is detected for 4 seconds VFIB/VTAC Ventricular tachycardia: The fibrillation waveform lasts for 4 consecutive seconds; or the number of continuous Vent beats is larger than the upper limit of cluster Vent beats (>5). The RR interval is less than 600 ms. VT>2 3< the number of cluster PVCs < 5 COUPLET 2 consecutive PVCs BIGEMINY Vent bigeminy TRIGEMINY Vent trigeminy R ON T A type of single PVC when HR<100,R-R interval is less than 1/3 the average interval, followed by a compensating pause of 1.25X the average R-R interval (the next R wave encroaches on the previous T wave). PVC All other single PVCs. - 53 - Instructions for Use Vista 120 Patient Monitor TACHY 5 consecutive QRS complex, RR interval is less than 0.5 s. BRADY 5 consecutive QRS complex, RR interval is longer than 1.5 s. MISSED BEATS When HR is less than 100 beats/min. no heart beat is detected during the period 1.75 times of the average RR interval; or When HR is higher than 100 beats/min. no beat is detected within 1 second. IRR The patient has an irregular heart rate. Check patient condition, electrodes, cables and leads. PNC After the pacemaker fires, QRS complex was not be detected for 300 ms. PNP After the QRS complex, no pacemaker activity is detected during 1.75 times of RR interval. VBRADY The patient has an irregular HR, and his average HR is less than 60 bpm. Check patient condition, electrodes, cables and leads. VENT The patient has an irregular heart rate. Check patient condition, electrodes, cables and leads. - 54 - Instructions for Use Vista 120 Patient Monitor ARR ANALYSIS menu Switching ARR analysis on and off To switch ARR Analysis on or off: From the ARR Analysis Setup menu, select ARR Analysis and toggle between On and Off. PVCs alarm Select On in the menu to enable the prompt message when an alarm occurs. Select Off to disable the alarm function. The symbol appears. WARNING When the PVCs Alarm is set to OFF, the monitor won’t give an alarm prompt even if an alarm occurs. In order to avoid endangering the patient’s life, the user should use this function cautiously. ARR relearning Select this item to start a learning procedure. ECG ARR LEARNING is displayed on the screen. The ECG ARR LEARNING will start automatically the following: • Changing lead type; • Connecting leads; • Updating the patient category; • Starting ARR learning manually; • After the ARR analysis is switched on; • The module is set to on; • Calibration mode is changed to normal measurement mode; • Exiting the Demo mode; • Exiting the standby mode; ARR alarm The user can switch on or off all arrhythmia alarms by selecting ECG Setup > ARR Analysis > ARR Setup > ARR Alarm. Individual arrhythmia alarms can be turned on or off. These are: ASYSTOLE, VFIB/VTAC, R-ON-T, VT>2, COUPLET, PVC, BIGEMINY, TRIGEMINY, TACHY, BRADY, MISSED BEATS, IRR, PNC, PNP, VBRADY and VENT. To switch individual alarms on or off, select ECG Setup > ARR Analysis > ARR Setup > ARR Alarm. - 55 - Instructions for Use Vista 120 Patient Monitor Monitoring RESP Overview The monitor measures respiration from the amount of thoracic impedance between two ECG electrodes. The change of impedance between the two electrodes, (due to the thoracic movement), produces a respiratory waveform on the screen. RESP safety information WARNING If you do not set the detection level for the respiration correctly in manual detection mode, it may not be possible for the monitor to detect apnea. If you set the detection level too low, the monitor is more likely to detect cardiac overlay, and to falsely interpret cardiac overlay as respiratory activity in the case of apnea. WARNING The respiration measurement does not recognize obstructive and mixed apneas - it only initiates an alarm when a pre-adjusted time has elapsed since the last detected breath. WARNING If operating under conditions according to the EMC Standard EN 60601-1-2 (Radiated Immunity 3 V/m), field strengths above 1 V/m may cause erroneous measurements at various frequencies. Therefore it is recommended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit. NOTE The RESP monitoring is not recommended to be used on patients who are very active, as this can cause false alarms. Resp display Resp 14 30 8 Electrode placement for monitoring resp Correct patient skin preparation for electrode placement is important for Resp measurement. Refer to the chapter on ECG for more information. - 56 - Instructions for Use Vista 120 Patient Monitor The Resp signal is always measured between two of the ECG electrodes. There are two standard ECG leads for selection: I lead (RA and LA) and II lead (RA and LL). Electrodes Placement for 5-lead Cardiac overlay Cardiac activity that affects the Resp waveform is called cardiac overlay. This occurs when Resp electrodes detect impedance changes caused by rhythmic blood flow. Correct electrode placement can reduce cardiac overlay. Chest expansion Some patients, especially neonates, expand their chests laterally. In this case, place the two respiratory electrodes in the right midaxillary and left lateral chest areas at the maximum expansion point. This placement optimizes respiratory waveform results. Abdominal breathing Some patients with restricted chest movement breathe mainly abdominally. In this case, place the LL electrode on the left abdomen at the point of maximum abdominal expansion. This placement optimizes respiratory waveform results. NOTE Place the red and green electrodes diagonally to optimize the respiration waveform. Do not position electrodes over the liver or the heart’s ventricles. This is an especially important safety procedure for neonates. Selecting resp lead To change Resp lead: From the Resp Setup menu, select Resp Lead, then choose the appropriate lead from the pop-up list. - 57 - Instructions for Use Vista 120 Patient Monitor Changing hold type To change the calculation mode: From the Resp Setup menu, set Hold Type to Manual or Auto. When set to AUTO mode, Hold High and Hold Low are unavailable, and the monitor calculates the respiration rate automatically. When set to Manual mode, the broken lines in RESP area can be adjusted by using Hold High and Hold Low. Changing the size of the respiration waveform Select the Resp waveform area to display the Resp waveform menu: • Select AMP and select the desired value. Larger values increase the waveform amplitude. • Select Sweep: Select an appropriate setting from the pop-up list. Using Resp alarms The User can turn Resp alarms on and off and set high and low alarm limits using the same procedures as described in the chapter “Alarms”. Changing the apnea time The apnea alarm is a high priority red alarm. The apnea alarm delay time is the period between no detected respiratory activity and alarm activation. 1. In the Resp Setup menu, select RESP APNEA. 2. Select the desired setting from the pop-up list - 58 - Instructions for Use Vista 120 Patient Monitor Monitoring SpO2 Overview The SpO2 value is derived from the absorption of pulse blood oxygen by red and infrared light using a finger sensor and a SpO2 measuring unit. SpO2 Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood. If, for example, 97 % of the hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has a SpO2 oxygen saturation of 97 %. The SpO2 numeric on the monitor will read 97 %. The SpO2 numeric shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin. The SpO2/PLETH parameter can also provide a pulse rate signal and a plethysmogram waveform. SpO2 safety information WARNING If the SpO2 sensor does not work properly, reconnect the sensor or use a new one. WARNING Do not use sterile supplied SpO2 sensors if the packaging or the sensor is damaged. WARNING Prolonged and continuous monitoring may increase the risk of unexpected change of dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive putrescence, and so on. It is especially important to check the sensor placement of neonatal patients and patients with poor perfusion or immature dermogram by light collimation and proper attaching strictly according to changes of the skin. More frequent examinations may be required for different patients. WARNING Tissue damage may be caused by incorrect application or prolonged measurement duration using the sensor (more than 4 hours). Inspect the sensor periodically according to the sensor user manual. WARNING Neonate SpO2 sensor can only be used when required, no more than 20 min at a time. WARNING Use only Dräger permitted sensors and extension cables with the oximeter. Other sensors or extension cables may cause improper monitor performance and/or minor personal injury. NOTE • Make sure the fingernail covers the light window. The wire should be placed on the backside of the hand. • The amplitude of the SpO2 waveform is not proportional to the pulse volume. - 59 - Instructions for Use Vista 120 Patient Monitor • Avoid placing the sensor on extremities with an arterial catheter, or intravascular venous infusion line. • Do not use a functional tester to access the SpO2 accuracy. • The function of SpO2 measurement does not require calibration. • The materials with which the patient or any other person can come into contact must be conforming to standard ISO10993. Measuring SpO2 1. Select the correct patient category setting (adult/pediatric and neonatal). This is used to optimize the calculation of the SpO2 and pulse numerics. 2. During measurement, ensure that the application site: - has a pulsatile flow, ideally with a good circulation perfusion. - has not changed in its thickness, causing an improper fit of the sensor. Measurement procedure 1. Switch on the monitor. 2. Attach the sensor to the appropriate site of the patient finger. 3. Plug the sensor extension cable connector into the SpO2 socket on the SpO2 module. Mounting of the Sensor WARNING Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. NOTE Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. - 60 - Instructions for Use Vista 120 Patient Monitor Interference can be caused by: • High levels of ambient light or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material.) • Electromagnetic interference. • Excessive patient movement and vibration. Understanding SpO2 alarms This chapter describes SpO2 specific alarms. See the chapter “Alarms” for general alarm information. SpO2 alarms are adjustable and have high and low limits. Adjusting alarm limits In SpO2 Setup menu: • Select the SpO2 High Alarm Limit and chose the desired high alarm limit. • Select the SpO2 Low Alarm Limit and chose the desired low alarm limit. WARNING High oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration do not set the high alarm limit to 100 %, which is equivalent to switching the alarm off. Setting SpO2 as pulse source 1. In the PR Setup menu, select PR Source; 2. Select SpO2 from the pop-up list. Setting pitch tone If tone modulation is on, the PR sound lowers when the SpO2 level drops. In SpO2 Setup menu, select pitch tone to toggle between On and Off. Setting sensitivity Sensitivity allows the user to set the refresh frequency. High is the highest SpO2 refresh frequency value. To change the sensitivity: 1. Select the SpO2 Setup menu; 2. Select Sensitivity and set the desired sensitivity from the pop-up list. - 61 - Instructions for Use Vista 120 Patient Monitor Monitoring PR Overview The pulse numeric counts the arterial pulsations that result from heart mechanical activity in beats per minute (bpm) from the measured SpO2 signal. Setting PR volume Six selections are available: 0, 1, 2, 3, 4, and 5. 5 is the maximum volume. 0 is mute. PR Volume can be changed in the PR Setup menu. Using pulse alarms The user can change pulse rate alarm limits in the PR Setup menu by selecting PR Alarm Limit. Pulse alarms are only generated when the active alarm source is set to Pulse. The pulse source is set as system pulse and pulse alarms are switched on. Selecting the active alarm source In most cases, the HR and Pulse numerics are identical. To avoid simultaneous alarms on HR and Pulse, the monitor uses either ECG or Pulse as its active alarm source. To change the alarm source, select Alarm Source in the ECG/Pulse Alarms menu, then select • HR: If HR should be the alarm source for HR/Pulse. • PR: If Pulse is selected as the active alarm source, the monitor will prompt the user to confirm his choice. If Pulse is selected as the alarm source, all arrhythmia and ECG HR alarms are switched off. • AUTO: If the Alarm Source is set to Auto, the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without a technical alarm condition. The monitor will automatically switch to Pulse as the alarm source. - 62 - Instructions for Use Vista 120 Patient Monitor Monitoring NIBP Overview This monitor uses the oscillometric method for measuring NIBP. It can be used for adult, pediatric and neonatal patients. Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. In adult and pediatric mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10-1992) in relation to mean error and standard deviation, when compared to auscultatory measurements in a representative patient population. For the auscultatory reference, the fifth Korotkoff sound was used to determine the diastolic pressure. In neonatal mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10-1992) in relation to mean error and standard deviation, when compared to intra-arterial measurements in a representative patient population. NIBP safety information The monitor and peripheral devices are protected against high-frequency interference from defibrillators and electrosurgical units and against 50- and 60-Hz power line interference. WARNING Do not measure NIBP on patients with sickle-cell disease or any condition where skin damage has occurred or is expected. WARNING Use clinical judgment to decide whether to perform frequent unattended blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff. WARNING Before starting a measurement, verify that you have selected a setting appropriate for your patient (adult, child, or neonate). An incorrect setting may be dangerous for children, because of higher measurement pressures. WARNING Do not apply the cuff to a limb that has an intravenous infusion or catheter in place. This could cause tissue damage around the catheter when infusion is slowed or blocked during cuff inflation. - 63 - Instructions for Use Vista 120 Patient Monitor WARNING Make sure that the air tubing connecting the blood pressure cuff and the monitor is neither blocked nor tangled. NOTE • Do not start NIBP measurements during low battery conditions (the monitor may turn off automatically). • If an alarm occurs or measurement fails, discontinue the measurement. • If you spill liquid onto the equipment or accessories, particularly if there is a chance that it can get inside the tubing or the measurement device, contact your service personnel. • Continuous use of the automatic measuring mode for short intervals may lead to the discomfort of the patient. Measurement limitations Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 240 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible in the following situations: • A regular arterial pressure pulse is hard to detect. • Patients with cardiac arrhythmias. • Patients with excessive and continuous movement such as shivering or convulsions. • Patients with rapid blood pressure changes. • Patients with severe shock or hypothermia that reduces blood flow to the periphery. • Obese patients, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery. • Patients with an edematous extremity. Measurement methods There are three methods of measuring NIBP: • Manual - measurement on demand. • Auto - continually repeated measurements (between 1 and 480 minute adjustable interval). • Continual - NIBP measurements run consecutively in five minutes, and then the monitor switches to manual mode. - 64 - Instructions for Use Vista 120 Patient Monitor WARNING Prolonged non-invasive blood pressure measurements in Auto mode may be associated with purport, ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color, warmth and sensitivity. If any abnormality is observed, stop the blood pressure measurements. Measurement procedures 1. Connect the air hose and switch on the monitor. 2. Attach the blood pressure cuff to the patient's arm or leg and follow the following instructions. Ensure that the cuff is completely deflated. Attach the appropriate size cuff to the patient (For information about cuff size selection, refer to the chapter “NIBP accessories”), and ensure the symbol "Φ" is over the artery. Ensure that the cuff is not wrapped too tightly around the limb. Excessive tightness can cause discoloration and ischemia of the extremity. NOTE The width of the cuff should be either 40 % of the limb circumference (50 % for neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 50-80 % of the limb. The wrong size of cuff can cause erroneous readings. If you are unsure what size to use, consult a physician or use a large size cuff. Cuff Usage 3. Connect the cuff to the air tubing. 4. Check if the patient mode is appropriate. Access the Patient Setup menu from Menu and select Type. Turn the knob to select the desired patient Type. 5. Select a measurement mode in the NIBP Setup menu. Refer to chapter “Operation Prompts” for information. 6. Press the button on the front panel to start a measurement. - 65 - Instructions for Use Vista 120 Patient Monitor Operation prompts 1. Manual measurement - Access the NIBP Setup menu and set the Measure Mode item to Manual. Press the - button on the front panel to start a manual measurement. During the idle period between AUTO measurements, press the button on the front panel at any time to start a manual measurement. Press the button again to stop the manual measurement. This allows the system to continue to take AUTO measurements according to the selected time interval. 2. Automatic Measurement Access the NIBP Setup menu and set the Measure Mode item to Auto. button on the front panel to start the AUTO measurement according to the Press the selected time interval. 3. Continuous measurement Access the NIBP Setup menu and select the Continual item to start a continuous measurement. The continuous measurement will last 5 minutes. 4. Stopping continuous measurement During continuous measurement, press the stop. button on the front panel at any time to Correcting the measurement if limb is not at heart Level The following measurement corrections should be applied if the limb is not at heart level: Add 0.75 mmHg (0.10 kPa) for each cm higher or Subtract 0.75 mmHg (0.10 kPa) for each cm lower or Add 1.9 mmHg (0.25 kPa) for each inch higher Subtract 1.9 mmHg (0.25 kPa) for each inch lower NIBP alarm When NIBP Alarm is On, the physological alarm occurs if any measurement value of Systolic pressure, Mean pressure, Diastolic pressure is outside the alarm limits. The user can adjust the alarm limit by accessing NIBP Setup > Alarm Setup > Sys Alarm/Mean Alarm/Dia Alarm. Resetting NIBP When NIBP does not work properly and the system does not generate an error message, select Reset in the NIBP Setup menu to activate the self-test procedure. This function restores the system. - 66 - Instructions for Use Vista 120 Patient Monitor Calibrating NIBP NIBP is not user-calibrated. Cuff-pressure transducers must be verified and calibrated, if necessary, at least once every two years by a qualified service professional. See the Service Guide for details. Leak test This item is used for the leak test. Turn the knob to select the Leak Test item in the User Maintain > NIBP Maintain menu to start the air leakage test. When the item is selected, it will change to Stop. If this item is selected again, the system will stop air leakage test and the item returns to Leak Test. WARNING This pneumatic test, other than being specified in the EN 1060-1 standard, is to be used by the user to simply determine whether there are air leaks in the NIBP airway. If, at the end of the test, the system gives the prompt that the NIBP airway has air leaks, contact the manufacturer for repair. Procedure for leak testing 1. Connect the cuff securely with the socket for NIBP air hole. 2. Wrap the cuff around the cylinder of an appropriate size. 3. Access User Maintain > NIBP Maintain 4. Turn the knob to the Leak Test item and press the item. Then the prompt of Leak Testing will appear indicating that the system has started performing the leak test. 5. The system will automatically inflate the pneumatic system to about 180 mmHg. 6. After 20 seconds, the system will automatically open the deflating valve, which marks the completion of a pneumatic measurement. If the prompt of Leak Test OK appears, it indicates that the airway is in good condition and no air leaks exist. However if the alarm information of NIBP Cuff Leak appears, it indicates that the airway might have air leaks. In this case, the user should check for loose connections. After confirming secure connections, the user should re-perform the pneumatic test. If the failure prompt still appears, contact DrägerService. Diagram of NIBP Air Leakage Test - 67 - Instructions for Use Vista 120 Patient Monitor Monitoring TEMP Overview Body temperature is measured using a thermistor probe (a semiconductor whose resistance changes with temperature) placed appropriately on the patient. Two TEMP probes can be used simultaneously to measure two TEMP values. The monitor automatically calculates the temperature difference. The default configuration is axilla sensor for adult. TEMP safety information WARNING Verify probe cables fault detection before using the probe to monitor the patient. If you unplug the temperature probe cable of channel 1 from the socket, the screen will display the error message TEMP1 SENSOR OFF and the audible alarm is activated. It is the same for the other channel. WARNING Handle the TEMP probe and cable carefully. When they are not in use, you should coil the probe and cable into a loose circle. Pulling the wire inside the cable may mechanically damage the probe and the cable. NOTE Disposable TEMP probe can only be used once per patient. TEMP monitoring setup • If disposable TEMP probes are used, connect the TEMP cable to the monitor and then connect the probe to the cable. With a reusable TEMP probe the probe can be connected directly to the monitor. • Apply the TEMP probes securely to the patient. • Switch on the monitor It takes 2 to 3 min for the body temperature to stabilize. Calculating temp difference The monitor can calculate and display the difference between two temperature values by subtracting the second value from the first. The difference is labeled TD. - 68 - Instructions for Use Vista 120 Patient Monitor Monitoring IBP (optional) Overview IBP is measured by means of a catheter inserted into the circulatory system. A pressure transducer connected to the catheter converts the mechanical force exerted by the blood into an electrical signal. This is displayed graphically as pressure versus time and as numerics on the monitor screen. The monitor measures direct blood pressure of one selected blood vessel through two channels and displays waveforms and numerics for the measured direct blood pressure (SYS, DIA and MAP). For further information on the IBP Kit, refer to the accompanying Instructions for Use of the manufacturer. IBP safety information WARNING The operator should avoid contact with the conductive parts of the device when it is connected to the patient. WARNING When the monitor is used with HF surgical equipment, avoid conductive connections of the transducer and the cables to the HF surgical equipment. This is to protect against burns to the patient. WARNING Disposable IBP transducer or domes should not be reused. WARNING If any kind of liquid, other than solution to be infused in pressure line or transducer, is splashed on the equipment or its accessories, or enters the transducer or the monitor, contact your service personnel immediately. NOTE • Use only the pressure transducer listed in the IBP accessories Monitoring procedures Preparatory steps for IBP measurement: 1. Connect the pressure cable to the corresponding socket and switch on the monitor. 2. Flush the system with a normal saline solution. Ensure that the system is free of air bubbles. 3. Connect the patient’s catheter to the pressure line. Ensure there is no air present in the catheter or pressure line. 4. Position the transducer so that it is at the same level as the patient’s heart, approximately mid-axillary line. - 69 - Instructions for Use Vista 120 Patient Monitor 5. For the label name selection, refer to chapter “Selecting a Pressure for Monitoring”. 6. To zero the transducer, refer to chapter “Zeroing the Pressure Transducer”. WARNING If there are air bubbles in the pressure line or the transducer, flush the system with the infused solution. Selecting a pressure for monitoring The user can assign a pressure label to uniquely identify each pressure. The monitor then uses that label’s stored settings (i.e., for color, scale and alarm settings) and selects which algorithm is used to process the pressure signal. An incorrect label can lead to incorrect pressure values. To select the label, refer to the following table: Label Description ART Arterial blood pressure PA Pulmonary artery pressure CVP Central venous pressure ICP Intracranial pressure LAP Left atrial pressure RAP Right atrial pressure P1-P2 Alternative non-specific pressure labels Zeroing the pressure transducer To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with your hospital’s policy (at least once per day). Zeroing must be performed: • When a new transducer or tubing is used; • Every time the transducer cable is reconnected to the monitor; • If the monitor’s pressure readings seem to be incorrect. When using a pressure module, the zero information is stored in the module. To zero a pressure measurement: 1. Turn off the stopcock to the patient. 2. Vent the transducer to atmospheric pressure. This compensates for the static and atmospheric pressure exerted on the transducer. 3. In the setup menu for pressure, select Zero <Press>. 4. When the message <Press> zero done is displayed, close the stopcock to atmospheric pressure and open the stopcock to the patient. - 70 - Instructions for Use Vista 120 Patient Monitor Troubleshooting the pressure zeroing (taking art for example) The status message lists the probable cause of an unsuccessful calibration. Message Corrective Action Art ZERO FAIL Make sure that the transducer is not attached to the patient Art SENSOR OFF, FAIL Make sure that transducer is not off, and then proceed zeroing IN DEMO, FAIL Make sure that the monitor is not in DEMO mode. Contact service technician if necessary PRESSURE OVER RANGE, FAIL Make sure that the stopcock is vented to atmosphere. If the problem persists, contact service technician PULSATILE PRESSURE ZERO FAIL Make sure that the transducer is vented to air, not connected to a patient, and try again. IBP pressure calibration • Mercury calibration should be performed by the hospital technical personnel either whenever a new transducer is used, or as frequently as dictated by your hospital’s policy. • The purpose of the calibration is to ensure that the system gives accurate measurements. • Before starting a mercury calibration, a zero procedure must be performed. If the user needs to perform this procedure himself, he will need the following equipment: • standard sphygmomanometer • 3-way stopcock • tubing (approx. 25 cm long). The Calibration Procedure: 1. Close the stopcock that was open to atmospheric pressure for the zero calibration. 2. Attach the tubing to the sphygmomanometer. 3. Ensure that connection to patient is off. 4. Connect the 3-way connector to the 3-way stopcock that is not connected to the patient catheter. 5. Open the port of the 3-way stopcock to the sphygmomanometer. 6. Select the channel to be calibrated in the menu and select the pressure value to which the IBP is to be adjusted. - 71 - Instructions for Use Vista 120 Patient Monitor 7. Inflate to make the mercury bar rise to the setup pressure value. 8. Adjust repeatedly until the value in the menu is equal to the pressure value shown by the mercury calibration. 9. Press the Start button, the device will begin calibrating. 10. Wait for the calibrated result. Corresponding measures should be taken based on the prompt information. 11. After calibration, disassemble the blood pressure tubing and the attached 3-way valve. 4 3 2 5 1 6 1: Hydrargyrum pressure meter; 2: 3-way connector; 3: 3-way stopcock; 4: Pressure transducer; 5: Pressure transducer interface cable; 6: Monitor IBP Calibration Troubleshooting the pressure calibration The status line lists the probable cause of an unsuccessful calibration. Message Corrective Action Art SENSOR OFF, FAIL Make sure that sensor is not off, and then start the calibration. Contact service technician if necessary. IN DEMO, FAIL Make sure that the monitor is not in DEMO mode. Contact service technician if necessary. PRESSURE OVER RANGE, FAIL Make sure that transducer value has been selected in IBP CAL, and then start the calibration. Contact service technician if necessary. Pulsatile Pressure Calibration Fail Make sure that pressure value shown by hydrargyrum pressure meter is changeless. Contact service technician if necessary. - 72 - Instructions for Use Vista 120 Patient Monitor IBP alarm When Alarm Switch is On, the physological alarm occurs if any measurement value of Systolic pressure, Mean pressure, or Diastolic pressure is outside the alarm limits. The alarm limit can be adjusted by accessing XX Options (XX stands for the label name) > Setup > SYS Alarm > MEAN Alarm > DIA Alarm. - 73 - Instructions for Use Vista 120 Patient Monitor Monitoring CO2 (optional) Overview The monitor uses a Capnostat 5 CO2 module (c5) as the means for MainStream method CO2 monitoring. MainStream measurement uses a CO2 sensor attached to an airway adapter that is directly inserted into the patient’s breathing system. The principle of CO2 measurement is primarily based on the fact that CO2 molecules absorb 4.3μm infrared rays. Absorption intensity is proportional to the CO2 concentration of the patient sample. CO2 safety information WARNING Do not use the device in the environment with flammable anesthetic gas. WARNING The device should be used by trained and qualified medical personnel. WARNING Nitrous oxide, elevated levels of oxygen, helium, xenon, halogenated hydrocarbons, and barometric pressure can influence the CO2 measurement. WARNING The monitor will be damaged if any tube from the CO2 module is disconnected, or the air tube/the air inlet/the air outlet are plugged by water or other materials. WARNING The accuracy of the CO2 measurement will be affected by the following reasons: the airway was highly obstructed; a leaky airway connection or quick variation of environment temperature. WARNING Follow precautions for electrostatic discharge (ESD) and electromagnetic interference (EMI) to and from other equipment. WARNING In the presence of electromagnetic devices (e.g., electrocautery), patient monitoring may be interrupted due to electromagnetic interference. Electromagnetic fields up to 20V/m will not adversely affect module performance. WARNING Do not place the sensor cables or tubing in a way that may cause tangling or strangulation. WARNING Do not store the CO2 Module at temperatures less than -40 ºC or greater than +70 ºC. Do not operate the CO2 Module at temperatures less than 0 ºC or greater than 40 ºC. - 74 - Instructions for Use Vista 120 Patient Monitor NOTE After the low battery alarm appears, do not start the CO2 measurement. The monitor may turn off from lack of battery power. Monitoring procedures Zeroing the sensor Zeroing must be performed according to the following procedure when using a new airway adapter: 1. Expose the sensor to room air, but not to any source of CO2. This includes the ventilator, patient, and operator. 2. Select CO2 Setup, and change Work Mode from Standby to Measure. 3. In the CO2 Setup menu, select Zero Calibration. 4. If the system briefly displays Zeroing, the process is successful. After the zeroing calibration is finished, you can start CO2 Monitoring. If the system displays Breath detected or Zero required, zeroing has failed. Zero calibration must be performed again. C5 CO2 module NOTE You must perform a zero calibration as described in this procedure each time you use a new airway adapter. C5 CO2 module Measurement steps 1. Attach the sensor connector to the CO2 connector on the monitor. 2. Wait two minutes, allowing the sensor to reach its operating temperature and a stable thermal condition. 3. Choose the appropriate airway adapter and connect it to the sensor head. The airway adapter clicks into place when seated correctly. - 75 - Instructions for Use Vista 120 Patient Monitor Connecting Sensor 4. To zero the sensor, refer to zeroing the sensor; 5. Install the airway adapter at the proximal end of the circuit between the elbow and the ventilator Y-section. Connecting Airway Adapter WARNING Accuracy is affected by temperature and barometric pressure. WARNING Installing or removing the CO2 module when the monitor is working may make the monitor unstable. If you do it inadvertently, turn off the module in menu immediately. The module enters STANDBY mode if you reconnect it to monitor which it is powered on. If the readings are inaccurate, you should do calibration. NOTE • Replace the airway adapter if excessive moisture or secretions are observed in the tubing or if the CO2 waveform changes unexpectedly without a change in patient status. - 76 - Instructions for Use Vista 120 Patient Monitor • To avoid infection, use only sterilized, disinfected, or disposable airway adapters. • Inspect the airway adapters prior to use. Do not use if airway adapter appears to have been damaged or broken. Observe airway adapter color coding for patient population. • Periodically check the flow sensor and tubing for excessive moisture or secretion buildup. Removing exhaust gases from the system WARNING Anesthetics: when using the CO2 measurement on patients who are receiving or have recently received anesthetics connect the outlet to a scavenging system, to avoid exposing medical staff to anesthetics. Use an exhaust tube to remove the sample gas to a scavenging system. Attach the tube to the mainstream sensor at the outlet connector. Setting CO2 waveform setup Select the CO2 waveform area to display the CO2 waveform menu: 1. Set Mode to Curve or Filled as desired. 2. Set Sweep to an appropriate value from the pop-up list. The larger the value, the faster the speed. Setting CO2 corrections Temperature, water vapor in the patient’s breath, barometric pressure, and the proportions of O2, N2O and Helium in the mixture all influence CO2 absorption. If values seem inaccurately high or low, check that the monitor is using the appropriate corrections. Baro Press, O2 Compens, Balance Gas and Anes Agent can be selected. Changing CO2 alarms This chapter describes specific CO2 alarms. See the chapter “Alarms” for general alarm information. To change the alarm, refer to the following steps: 1. Select the CO2 Setup menu to display that menu. 2. Select etCO2 Alarm Setup, FiCO2 Alarm Setup or AwRR Alarm Setup to adjust the alarm limit. - 77 - Instructions for Use Vista 120 Patient Monitor Changing apnea alarm This function allows the user to set an apnea alarm that monitors a time limit if a patient ceases breathing. 1. Select the CO2 Setup menu. 2. Select Apnea Alm. 3. Choose the apnea alarm time from the pop-up list. WARNING Safety and effectiveness of the respiration measurement method in the detection of apnea, particularly the apnea of prematurity and apnea of infancy, has not been established. - 78 - Instructions for Use Vista 120 Patient Monitor Freeze Overview When monitoring a patient, the user can freeze waveforms and examine them. Generally, the user should not view frozen waveforms for longer than 60 seconds. The Freeze function has the following features: • Freeze status can be activated on any operating screen. • Upon freezing, the system exits all other operating menus. The system freezes all waveforms in the Waveform area of the Basic Screen, the Full Lead ECG waveforms and extra waveforms on the Full Lead ECG interface (if any). The Parameter area refreshes normally. • The frozen waveforms can be reviewed and recorded. Entering/exiting freeze status Entering freeze status In the non-Freeze status, press the hardkey on the monitor control panel to exit the current menu. Freeze status is entered and the pop-up Freeze menu is displayed. In Freeze status, all waveforms are frozen and will not be refreshed. Exiting freeze status Executing any of the following operations will exit Freeze status: 1. Select Exit option in/from the Freeze menu; 2. Press hardkey on the control panel again; 3. Execute any operation that triggers the adjustment of the screen or displays a new menu. After exiting Freeze status, the system will clear screen waveforms and resume displaying real-time waveforms. In the Screen Refresh mode, the system will sweep the waveforms from left to right in the Waveform Area. Press the hardkey on the control panel, and the Freeze menu will appear on the bottom part of the screen. At the same time, the system freezes the waveforms. • REC WAVE: can be set to any waveform of 8 s, such as IBP1, CO2, PLETH etc. It can also be set to OFF. • Review: Used to review frozen waveforms. • Exit: The system closes the Frozen menu and exits Freeze status. NOTE Pressing the hardkey repeatedly over a short period of time may result in discontinuous waveforms on the screen. - 79 - Instructions for Use Vista 120 Patient Monitor Reviewing frozen waveform By moving the waveform, the user can review 120 seconds of the waveform before it was frozen. For a waveform of less than 60 seconds, the remaining part is displayed as a straight line. The rotary knob on the control panel can be used to move the cursor to the Review option in the Freeze menu. Press the knob. By turning the knob left or right, frozen waveforms on the screen will move left or right correspondingly. There is an arrow indicating upward on the right side of the last waveform. - 80 - Instructions for Use Vista 120 Patient Monitor Review The monitor provides 120-hour trend data of all parameters, storage of 1200 NIBP measurement results and 60 alarm events. This chapter gives detailed instruction for review of all data. Trend graph review • The latest 1-hour trend displays data taken every 1 or 5 seconds. • The latest 120-hour trend displays data taken every 1, 5 or 10 minutes. To review the Trend Graph, press the Trend hardkey on the front panel or select Menu > Review > Trend Graph. In the trend graph, the y-axis is the measurement value and x-axis represents time. Selecting trend graph of specific parameter The monitor can display trend graphs of different parameters. To select a different parameter’s trend, select Menu > Review > Trend Graph and select the desired parameter name from the pop-up list (as shown in red text on the above figure). Setting resolution To set an appropriate resolution, select Menu > Review > Trend Graph. Choose Resolution to display the list and select a resolution ranging from 1 sec, 5 sec, 1 min, 5 min and 10 min. Scrolling the screen Not all trend graphs are displayed on the current screen. To see other trend graphs, press the symbols and displayed on the trend graph. - 81 - Instructions for Use Vista 120 Patient Monitor Switching to the trend table To switch to the trend table, select Trend Table. Record The monitor can print the data in the current trend window. For more information, refer to chapter “Strip recording”. Trend table review To review the trend table, press the Trend Table shortcut key on the screen or select Menu > Review > Trend Table. Setting resolution To set an appropriate resolution, select Menu > Review > Trend Table. Choose Resolution to display the list and select a resolution ranging from 1 sec, 5 sec, 1 min, 5 min and 10 min, 30 min and 60 min. Scrolling the screen Not all trend tables can be displayed on the current screen. To see other measurement trend tables, press the symbols , , and displayed on the trend graph. Switching to trend graph The user can switch to the trend graph on the Trend Table dialog box. Select Menu > Review > Trend Graph and select the Trend Graph option from the pop-up dialog box. - 82 - Instructions for Use Vista 120 Patient Monitor Recording The monitor can make a tabular trend recording of the data in the current trend graph window. The report uses the current trend interval settings. For more information, refer to chapter “Recording”. NIBP review To review the NIBP measurement data, select the NIBP Review key on the screen or select Menu > Review > NIBP Review. The NIBP Review window is displayed. Scrolling the screen Not all measurement data is displayed on the current screen. To see other measurement data, press the symbols and displayed on the NIBP Review dialog box. Recording The monitor can record the measurement data in the NIBP review window. For more information, refer to chapter “Recording”. Alarm review The monitor can store up to 60 alarm events and displays the last 10 alarm events. To review the alarm event, select the Alarm Review key on the screen or select Menu > Review > Alarm Review. The Alarm Review dialog box is displayed. Scrolling the screen Not all alarm events are displayed on the current screen. To see other alarm events, press the symbols and displayed on the Alarm Review dialog box. Selecting alarm event of specific parameter The monitor can review an alarm event of a specific parameter. To view the alarm event of the specific parameter, select Menu > Review > Alarm Event and choose Event Type to select the desired parameter name from the pop-up list. Setting time index The user can set End time of alarm review by selecting the Time Index option displayed on the Alarm Event Review dialog box. If the user selects Current Time on the pop-up dialog box, the alarm events occurring before the current time are displayed on the alarm event review dialog box. - 83 - Instructions for Use Vista 120 Patient Monitor If the user selects User Define, he can define the review time by setting Year, Month, Day, Hour, Min and Sec. The alarm events occur before the User Define option is displayed on the alarm event review dialog box. Recording The monitor can record the alarm event in the alarm event review window. For more information, refer to chapter “Recording”. Arr review Select ECG Setup > Arr Analysis> Arr Review or Menu > Review > Arr Review to display the Arr Review dialog box. The dialog box displays the latest arrhythmia events. Selecting specific arrhythmia event The monitor can review a specific arrhythmia event. To view the specific arrhythmia event, select Menu > Review > Arrhythmia Review > Rename and choose the desired name from the pop-up list. Scrolling the screen Not all arrhythmia events can be displayed on the current screen. To see the other arrhythmia events, press the symbol and displayed on the Arrhythmia Review dialog box. Deleting arrhythmia events The user can delete the arrhythmia events displayed on the current screen by selecting Delete on the Arrhythmia Review dialog box. Recording The monitor can record the waveforms of the arrhythmia events displayed on the current screen. For more information, refer to chapter “Recording”. - 84 - Instructions for Use Vista 120 Patient Monitor Calculation and titration table The monitor provides a calculation function and titration table. Calculations are patient data that are not directly measured but calculated by the monitor. The monitor can perform drug calculations. Hemodynamic calculations are not described in this Instructions for Use. To perform a calculation, select Menu > Common Function > Drug Cal. NOTE The drug calculation function acts only as a calculator. The patient weights in Drug Calculation menu and in Patient Information menu are independent of each other. Therefore changing the Weight in Drug Calculation menu will not change the weight in the Patient Information menu. Drug calculation Calculation procedures 1. The drug calculation window is displayed by selecting Menu > Common Function > Drug Calc. 2. Select the right pull-down Drug Name option and select the desired drug name among the 15 drugs which are listed as follows. The names of drug Drug A, Drug B, Drug C, Drug D and Drug E can be defined by the user. • Drug A, Drug B, Drug C, Drug D and Drug E • AMINOPHYLLINE • DOBUTAMINE • DOPAMINE • EPINEPHRINE • HEPARIN • ISUPREL • LIDOCAINE • NIPRIDE • NITROGLYCERIN • PITOCIN 3. The system generates default values that cannot be treated as calculation results. The user must input the correct parameter values. 4. Input the patient’s weight. 5. Input the correct parameter value. 6. Confirm if the calculation result is correct. - 85 - Instructions for Use Vista 120 Patient Monitor Calculation unit Each drug has the fixed unit or unit series that is used for it. Within the same unit series, the numeric value is automatically scaled up or down as needed. The calculation units of the drugs are as follows: Drug Unit DRUG A, DRUG B, DRUG C, AMINOPHYLLINE, g, mg, mcg DOBUTAMINE, DOPAMINE, EPINEPHRINE, ISUPREL, LIDOCAINE, NIPRIDE, NITROGLYCERIN DRUG D, PITOCIN, HEPARIN Ku, mu, Unit DRUG E mEq When defining a drug, select Drug A, Drug B, Drug C, Drug D, and Drug E based on the unit series. NOTE • The drug calculation is displayed as invalid prior to data entry. • Drip Rate and Drop Size are invalid in neonatal mode. Titration table After completing the drug calculation, the user can display the Titration on the Drug Calc dialog box. The user can change the following items in the titration table: • Basic • Step • Dose Type The data in the trend table will vary with the changes above. The user can perform the following: • Scroll up and down the screen by selecting the symbol graph. • Record the data displayed in the current dialog box by selecting the button Record. - 86 - and displayed on the trend Instructions for Use Vista 120 Patient Monitor Strip recording General information A thermal dot matrix recorder is used for the monitor and can support a number of recording types and output patient information, measurement data, and review data waveforms. 1 4 3 2 1 Start/Stop key. Press this key to start or stop recording task. 2 Recorder door 3 Paper outlet 4 Recording indicator Performance of the recorder • Waveform record printed at the rate of 25 mm/s or 50 mm/s. • 48 mm wide printout paper. • Record up to three waveforms. • User-selectable real-time recording time and waveform. • Auto recording interval is set by the user and the waveform displays in real time. NOTE You should not use the strip recorder with a low battery as recorder usage will more quickly deplete the battery. Recording type The monitor provides several types of strip recordings: • Continuous real-time recording - 87 - Instructions for Use Vista 120 Patient Monitor • Time recording • Alarm recording • Trend graph, trend table recording • Arrhythmia review recording • Drug calculation titration recording • NIBP review recording • Alarm review recording Starting and stopping strip recording The strip recording can be started and stopped in the following ways: Continuous real-time recording Press the Start/Stop hardkey on the printer or the Recording hardkey on the monitor to start the strip recording, and repress it to stop the strip recording. Auto recording Record the three waveforms selected in the Record menu for the duration defined in the Record menu. The strip recording automatically stops in 8 seconds. Alarm recording When alarm recording is ON, it automatically starts when alarm occurs. Trend graph recording Display the Trend Graph menu, and then press the Record button in the dialog box to start strip recording. Trend table recording Display the Trend Table menu, then press the Record button in the dialog box to start strip recording. Arrhythmia review recording Display the ECG Setup menu via shortcut key, select ARR Analysis > ARR Review, and then press the Record button in the dialog box to start strip recording. Alarm review recording Display the Alarm Review menu, then press the Record button in the dialog box to start strip recording. NIBP review recording Display the NIBP Review menu, then press the Record button in the dialog box to start recording. Titration table recording Display the Drug Calc menu from the Menu. Pick the Titration button in the menu to access the Titration window. Press the Record button to print out the currently displayed titration table. - 88 - Instructions for Use Vista 120 Patient Monitor The recorder will stop recording in the following situations: • The strip recording task is finished. • When the Start/Stop button on the front panel of the printer is pressed while the printer is printing. • No paper in the recorder. • Because of malfunction. Recorder operations and status messages Record paper requirement CAUTION Only use standard thermo-sensitive record paper. If non-standard record paper is used, the recorder might not function, the recording quality may be poor, and the thermo-sensitive printhead could be damaged. Proper operation • When the strip recorder is operating, do not pull the paper. • Do not operate the strip recorder without record paper. Paper out When the Recorder Out Of Paper alarm is displayed, the strip recorder will not start. Installling paper 1. Pull out the upper arc of the strip recorder casing as shown in the following figure. - 89 - Instructions for Use Vista 120 Patient Monitor 2. Insert a new roll of paper into the paper cassette, printing side facing upwards. 3. Position the paper correctly. 4. Pull 2 cm of paper out and close the strip recorder casing. NOTE Be careful when inserting paper. Avoid damaging the thermo-sensitive print head. Do not leave the strip recorder door open except to insert paper or troubleshoot printing problems. - 90 - Instructions for Use Vista 120 Patient Monitor Removing paper jam When the strip recorder malfunctions, open the strip recorder door to check for a paper jam. Remove the paper jam in the following way: • Cut the record paper from the feeding edge. • Open the strip recorder door. • Re-install the paper. NOTE • If the monitor is not installed with a strip recorder, it will indicate RECORDER SETUP NEEDED after pressing the Record button in the dialog box. • Do not touch the thermo-sensitive print head when performing continuous recording. - 91 - Instructions for Use Vista 120 Patient Monitor Other Functions Nurse call The monitor provides a dedicated nurse call port which can be connected to the hospital’s nurse call system. - 92 - Instructions for Use Vista 120 Patient Monitor Using battery Battery power indicator The indicator labeled Battery on the front panel of the monitor illuminates green when the monitor is battery powered and yellow when being charged. The indicator is not illuminated when the monitor is not powered or when using AC power. Battery status on the main screen The Battery Status shows the status of each battery detected and the combined battery power remaining. It also includes an estimate of the monitoring time remaining. Icon is shown when the battery is being charged. The yellow section represents the battery charge level. When fully charged, the section turns green. Icon is shown when the monitor is not equipped with a battery. Icon is shown is there is insufficient power. When the monitor is battery powered, the monitor switches off automatically if there is no power. Checking battery performance NOTE Remove the battery from the monitor when the monitor is not used for a long periods of time. The performance of rechargeable batteries may deteriorate over time. The battery should be conditioned regularly as follows: 1. Disconnect the patient from the monitor and stop all monitoring and measurement. 2. Switch the monitor power on and charge the battery for more than 6 hours continuously. 3. Disconnect the monitor and let it run until there is no battery power remaining and the monitor shuts off. 4. Reconnect the monitor to mains. This should improve the battery running time. If the running time is less than listed in the specification, change the battery or contact the customer service. WARNING Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to read these Instructions for Use and follow all safety precautions. WARNING Do not destroy, disassemble or modify the battery in any way. Do not short circuit the battery, or its terminals, to a metal object. - 93 - Instructions for Use Vista 120 Patient Monitor WARNING Do not unplug the battery while the monitor is monitoring a patient. WARNING Do not heat or throw battery into a fire. WARNING Do not store the battery at temperatures above 60 °C. WARNING Do not immerse, throw, or wet battery in water/seawater. WARNING Use the battery only in the monitor. Do not connect battery directly to an electric outlet or cigarette lighter charger. WARNING If liquid leaking from the battery gets into your eyes, do not rub your eyes. Wash them well with clean water and go to see a doctor immediately. If liquid leaks of the battery splash onto your skin or clothes, wash well with fresh water immediately. WARNING Keep away from fire immediately when leakage or foul odor is detected. WARNING Stop using the battery if abnormal heat, odor, discoloration, damage, deformation, or abnormal condition is detected during use, charge, or storage. Keep it away from the monitor. Replacing the battery To install or replace the battery: Battery door 1. Pull the battery door downwards to open it. 2. Pull the metal retainer until the battery can be removed. - 94 - Instructions for Use Vista 120 Patient Monitor 3. Insert the new battery into the battery compartment. 4. Pull the metal retainer downward to fix the battery and close the battery door. Recycling the battery When the battery no longer holds a charge, it should be replaced. Remove the old battery from the monitor and recycle it properly. NOTE To prolong the life of rechargeable battery, charge it at least once every six months for a charging time of about five hours. - 95 - Instructions for Use Vista 120 Patient Monitor Care and cleaning Use only the Dräger-approved substances and methods listed in this chapter to clean or disinfect the equipment. The warranty does not cover damage caused by using unapproved substances or methods. Dräger makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Contact infectious disease experts in your hospital for details. General points WARNING Before cleaning, sterilizing, or disinfecting the monitor or any accessory, make sure that the equipment is switched off and disconnected from the power line. Keep the monitor, cables, and accessories free of dust and dirt. CAUTION To prevent the device from damage, follow this procedure: • Always dilute cleaning, sterilizing, or disinfecting agents according to the manufacturer’s instructions or use the lowest possible concentration. • Do not immerse any part of the equipment or any accessory in liquid or pour liquid onto them. • Never use bleach. • Do not allow liquid to enter the case. • Never use abrasive material (such as steel wool or silver polish). CAUTION If you spill liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact your service personnel or DrägerService. Cleaning Cleaning the monitor Regular cleaning of the monitor shell and the screen are strongly recommended. Use only non-caustic detergents such as soap and warm water (40 °C maximum) to clean the monitor shell. Do not use strong solvents such as acetone or trichloroethylene. Exercise caution when cleaning the monitor screen. Do not permit liquids to enter the monitor case. Do not allow water or cleaning solution to enter the measurement connectors. Examples of disinfectants that can be used on the instrument casing are as follows: • Tenside; • Diluted Ammonia Water < 3%; - 96 - Instructions for Use Vista 120 Patient Monitor • Diluted Sodium Hypochlorite (Bleaching agent); • Diluted Formaldehyde 35 to 37 %; • Hydrogen Peroxide 3 %; • Alcohol; • Isopropanol. NOTE • The diluted sodium hypochlorite from 500 ppm (1:100 diluted bleaching agent) to 5000 ppm (1:10 bleaching agents) is very effective. The concentration of the diluted sodium hypochlorite depends on how many organisms (blood, mucus) on the surface of the chassis to be cleaned. • The monitor and sensor surface can be cleaned with hospital-grade ethanol and allowed to air dry or dried using a clean cloth. Cleaning the accessories Cleaning the Cables and Lead Wires CAUTION Do not use acetone or ketone solvents for cleaning; do not use an autoclave or steam cleaner. CAUTION The decision to sterilize must be made per your hospital’s policy with an awareness of the effect on the integrity of the cable and leadwire. Cables and leadwires can be cleaned with a warm, damp cloth and mild soap, or isopropyl alcohol wipes. Refer to the previous page for safe cleaning techniques. Cleaning the blood pressure cuff Use a soft brush to wash the cuff surface and clean as follows: NOTE • Do not immerse the rubber tube or allow liquid to enter either the cuff or the tube when washing it. • Do not scrub or knead the cuff. Cleaning the CO2 sensor Clean the sensor surface with a damp cloth. Ensure the sensor windows are clean and dry. • Do not immerse the sensor. • Do not attempt to sterilize the sensor. - 97 - Instructions for Use Vista 120 Patient Monitor An adapter can be cleaned by rinsing in a warm soapy solution, followed by soaking in a liquid disinfectant, pasteurized, or cold sterilized (glutaraldehyde). It should then be rinsed with sterile water and dried. Before reusing any adapter, ensure the windows are clean and free of any residue. For other applied parts, the manufacturer must be consulted for cleaning, sterilization, or disinfecting methods. Other accessories For cleaning other accessories, contact the manufacturers for details. Sterilization To avoid extended damage to the equipment, sterilization is only recommended when stipulated as necessary in the hospital’s policy. Sterilization facilities should be cleaned first. Recommended sterilization material: Ethylate and Acetaldehyde. Appropriate sterilization materials for ECG lead and blood pressure cuff are described in those chapters. WARNING Sterilize and disinfect as needed to prevent cross infection between patients. CAUTION Use a moistened cloth to wipe up any agent remaining on the monitor. Disinfection WARNING Mixing bleach and ammonia (or other disinfecting solutions) may produce hazardous gases. To avoid extended damage to the equipment, disinfection is only recommended when stipulated as necessary in the hospital’s policy. Disinfection facilities should be cleaned first. Appropriate disinfection materials for ECG leads, SpO2 sensor, blood pressure cuff, TEMP probe, IBP sensor are described in those chapters. Recommended types of disinfecting agents are: • Alcohol • Aldehyde CAUTION Do not use etO gas or formaldehyde to disinfect the monitor. - 98 - Instructions for Use Vista 120 Patient Monitor Maintenance WARNING Failure on the part of the responsible institution to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. WARNING If the monitor is mechanically damaged, or if it is not working properly, do not use it. Contact your technical personnel. WARNING If you discover a problem with any of the equipment, contact your service personnel or your authorized supplier. Inspecting The overall check of the monitor, including the safety check, should be performed by qualified personnel every 24 months, and following repair. The following items should be checked: • If the environmental condition and power supply meet requirements. • If the power supply cord is damaged and the insulation is not cut. • If the device and accessories are damaged. • Specified accessories. • If the alarm system works properly. • If the recorder works properly and there is sufficient paper. • Battery performance • If all monitoring functions are in good condition. • If grounding resistance and leakage function properly. If any damage or abnormality is found, do not use the monitor and contact customer support. Maintenance task and test schedule The following maintenance tasks are for Dräger-qualified service professionals only. Contact a Dräger-qualified service provider if the monitor needs a safety or performance test. Clean and disinfect equipment before testing or maintaining it. Maintenance and Test Schedule Frequency Safety checks. Selected tests on the basis of IEC 62353 At least once every two years, or as needed, following any repairs where the power supply is removed or replaced, or if the monitor has been dropped. - 99 - Instructions for Use Vista 120 Patient Monitor Maintenance and Test Schedule Frequency Check ECG synchronization of the At least once every two years, or as needed. monitor NIBP leakage inspection and calibrations At least once every two years, or as specified by local laws. CO2 calibration and performance test At least once every two years, or if you suspect the measurement values are incorrect. Replacing fuse To replace the blown fuse: 1. Switch off the monitor and unplug the power cable. 2. Carefully place the monitor upside down on a flat surface covered with cloth or other protecting pad. 3. Pull ot the fuse box from the groove and you will see the fuse. 4. Remove the old fuse. Take out a new fuse with the following specifications: Ф 5 mm x 20 mm: Model: T1.6AL 250 V. 5. Place the new fuse in the fuse socket and push the box back into position. - 100 - Instructions for Use Vista 120 Patient Monitor Disposal CAUTION The device and its components must be disinfected and cleaned before disposal! For countries subject to EU Directive 2002/96/EC: This device is subject to EU directive 2002/96/EC (WEEE). In order to comply with its registration according to this directive, it may not be disposed of at municipal collection points for waste electrical and electronic equipment. Dräger has authorized a company to collect and dispose of this device. To initiate take-back or for further information, visit us on the Internet at www.draeger.com and navigate to the DrägerService area where you will find a link to “WEEE”. If you have no access to our website, contact your loacal Dräger organization. - 101 - Instructions for Use Vista 120 Patient Monitor Service policy Repair of the device may only be carried out by trained service personnel otherwise the correct functioning of the device may be compromised. Regular bi-annual maintenance (functional and safety test) according to IEC 62353 is recommended, in addition to national regulations and laws (for example, accident prevention regulations). Connecting the medical device to other medical devices could result in additional maintenance requirements. Consult the documentation for these other devices to identify additional requirements. Dräger recommends contracting with DrägerService for any repairs. Use only authentic Dräger repair parts during maintenance. Using non-Dräger repair parts may adversely affect the operation of the device. If the product fails to function properly, or if assistance is needed, for service and for spare parts, contact Dräger’s service center. A representative will assist in troubleshooting the problem and will make every effort to solve it over the phone or e-mail, avoiding potential unnecessary returns. In case a return can not be avoided, the representative will record all necessary information and will provide a Return Material Authorization (RMA) form that includes the appropriate return address and instructions. An RMA form must be obtained prior to any return. If you have any questions about maintenance, technical specifications, or malfunctions of devices, contact your local distributor. - 102 - Instructions for Use Vista 120 Patient Monitor Accessories Accessories can be ordered from your local Dräger representative. WARNING Never reuse disposable transducers, sensors or other accessories that are intended for single-use or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard. WARNING Only use accessories that are approved by Dräger. Using accessories that are not approved by Dräger may compromise device functionality and system performance and cause a potential hazard. WARNING Do not use a sterilized accessory if its packaging is damaged. NOTE Transducers and sensors have a limited shelf life. Refer to the package labeling. The following cables may not all be available in all countries. Check availability with your local Dräger supplier. ECG accessories The following table lists the optional configuration for the monitor: Part Number Accessory 2606185 ECG trunk cable, 5-lead, Defib, IEC, 2.6 m, reusable 2606186 ECG limb wires, 5-lead, snap, IEC, 0.9 m, reusable 2606187 ECG limb wires, 5-lead, clip, IEC, 0.9 m, reusable 2606192 ECG cable, 5-lead, snap, Defi, AHA, 3.5 m, reusable 2606193 ECG cable, 5-lead, clip, AHA, 3.5 m, reusable 2606195 ECG cable, 3-lead, snap, AHA, 3.5 m, reusable 2606196 ECG trunk cable, 3-lead, Defib, IEC, 2.6 m, reusable 2606197 ECG limb wires, 3-lead, clip, IEC, 0.9 m, reusable 2606245 ECG Electrodes, adult, disposable, 30 pieces 2606200 ECG Electrodes, adult, disposable, 100 pieces 2606246 ECG Electrodes, child, neo disposable, 50 pieces - 103 - Instructions for Use Vista 120 Patient Monitor SpO2 accessories Part Number Accessory 2606201 SpO2 Finger Sensor, adult, 2.5 m, reusable 2606202 SpO2 Finger Sensor, adult, 1 m, reusable 2606205 SpO2 Silicone Soft-tip Sensor, adult, 1 m, reusable 2606206 SpO2 Silicone Soft-tip Sensor, pediatric, 1 m, reusable 2606207 SpO2 Extension cable, 2m 2606208 SpO2 Sensor, adult, 0.5 m, disposable, 25 pieces 2606209 SpO2 Sensor, pediatric, 0.5 m, disposable, 25 pieces 2606210 SpO2 Sensor, Infant, 0.5 m, disposable, 25 pieces 2606211 SpO2 Sensor, Neonate, 0.5 m, disposable, 25 pieces NIBP accessories Part Number Accessory 2606212 NIBP Cuff, Adult, 25 cm – 35 cm, reusable 2606213 NIBP Cuff, Larger Adult, 33 cm – 47 cm, reusable 2606214 NIBP Cuff, Child, 18 cm – 26 cm, reusable 2606215 NIBP Cuff, Infant, 10 cm – 19 cm, reusable 2606271 NIBP Cuff, Neonatal #1, 3 cm – 6 cm, disposable 2606272 NIBP Cuff, Neonatal #2, 4 cm – 8 cm, disposable 2606273 NIBP Cuff, Neonatal #3, 6 cm – 11 cm, disposable 2606274 NIBP Cuff, Neonatal #4, 7 cm – 13 cm, disposable 2606275 NIBP Cuff, Neonatal #5, 8 cm – 15 cm, disposable 2606218 NIBP Tube, 3 m 2606219 NIBP Tube, for neonatal cuff, 3 m - 104 - Instructions for Use Vista 120 Patient Monitor Temp accessories Part Number Accessory 2606220 Temperature Probe Skin, adult, 3 m, reusable 2606221 Temperature Probe, rectal / oral, 3 m, reusable IBP accessories Part Number Accessory 2606224 IBP Pressure transducer interface cable, BD 2606225 IBP Pressure transducer kit, BD, disposable, 5 pieces CO2 accessories Part Number Accessory 2606226 EtCO2 Module with disp. Adult airway adapter 2606227 CO2 Airway Adapter, Adult, disposable, 10 pieces 2606228 CO2 Airway Adapter, Neonatal (infant/pediatric), 10 pcs. Device accessories Part Number Accessory 2606229 Vista 120 Rechargeable Lithium-Ion Battery 2606231 Vista 120 Printing paper, 4 rolls 2606232 Vista 120 Ground Cable 2606233 Vista 120 Mounting adaptor Spare parts Part Number Accessory 2606229 Vista 120 Rechargeable Lithium-Ion Battery 2606260 Fuse - 105 - Instructions for Use Vista 120 Patient Monitor Technical Data Classification Protection class Class I equipment and internal powered equipment EMC class Group I, Class A Degree of protection against electric shock CF: ECG (RESP), TEMP, IBP BF: SpO2, NIBP, CO2 Liquid ingress protection IPX1 Disinfection/sterilization method Refer to chapter “Care and Cleaning” for details. Mode of operation Continuous Device specifications Size 408 mm (L) × 157 mm (W)× 316 mm (H) Weight 7 kg Ambient conditions Temperature Operating +5 to +40 °C Transport and storage -20 to +55 °C Relative humidity Operating 25 to 80 % (non-condensing) Transport and storage 25 to 93 % (non-condensing) Altitude Operating 860 to 1060 hPa Transport and storage 700 to 1060 hPa Leakage current Applied part Normal condition Single fault condition Earth leakage current <0.5 mA <1 mA Enclosure leakage current <0.1 mA <0.5 mA CF AC: <0.01 mA DC: <0.01 mA AC: <0.05 mA DC: <0.05 mA BF AC: <0.1 mA AC: <0.5 mA Patient leakage current - 106 - Instructions for Use Vista 120 Patient Monitor DC: <0.01 mA Patient leakage current (Mains on applied parts) Patient auxiliary current DC: <0.05 mA CF < 0.05 mA BF < 5 mA CF AC: <0.01 mA DC: <0.01 mA AC: <0.05 mA DC: <0.05 mA BF AC: <0.1 mA DC: <0.01 mA AC: <0.5 mA DC: <0.05 mA Power supply Power supply 100 to 240 V~, 50 Hz/60 Hz Pmax = 110 VA FUSE T 1.6 AL, 250 V Battery (optional) Quantity 1 Capacity 4.2 Ah Battery life 120 min (At 25 °C, continuous SpO2 measuring mode and NIBP automatic measuring mode) Battery charge time 320 min (Monitor is on or in standby mode.) Display Display Messages Display screen: 15” color TFT A maximum of 11 waveforms Resolution: 1024 × 768 One power LED Two alarm LEDs One charge LED Recorder Record width 48 mm Paper speed 25 mm/s, 50 mm/s Trace Up to 3 - 107 - Instructions for Use Vista 120 Patient Monitor Recording types 8 second real-time recording Auto 8 second recording Parameter alarm recording Trend recording Titration table recording Review Trend review Short 1 hr, 1 sec. resolution Long 120 hrs, 1 min. resolution Review 1200 sets NIBP measurement data ECG 3-, 5-lead monitoring Lead mode 3-Lead: I, II, III 5-Leads: I, II, III, aVR, aVL, aVF, V Waveform 3-Lead: 1-channel waveform 5-Lead: 2-channel waveform, max. seven waveforms; Lead naming style AHA, IEC Display sensitivity 1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1), 20 mm/mV (×2), AUTO gain Sweep 12.5 mm/s, 25 mm/s, 50 mm/s Bandwidth (-3dB) Diagnosis: 0.05 to 150 Hz Monitor: 0.5 to 40Hz Surgery: 1 to 20Hz CMRR (Common Mode Rejection Ratio) Diagnosis: >95 dB (the notch filter is off) Monitor: >105 dB (the notch filter is on) Surgery: >105 dB (the notch filter is on) Notch 50 Hz/60 Hz (notch filter can be selected manually) Differential input impedance >5 MΩ Input signal range ±8 mVPP - 108 - Instructions for Use Vista 120 Patient Monitor Electrode offset potential Tolerance ±500 mV Auxiliary current (Leads off detection) Active electrode: <100 nA Input offset current ≤0.1 μA Recovery time after defibrillation <5 s Patient leakage current <10 μA (normal condition) Scale signal 1 mVPP, accuracy is ±5 % System noise <30 μVPP ESU protection Cut mode: 300 W Reference electrode: <900 nA Coagulation mode: 100 W Recovery time: ≤10 s Meets the requirements of ANSI/AAMI EC13-2002: Sect. 4.1.2.1 a) ESU noise suppression Tested according to the test method in EC13: 2002 Sect.5.2.9.14, it complies with the standard. Pace pulse Pulse indicator Pulses are marked if the requirements of ANSI/AAMI EC13:2002, Sect. 4.1.4.1 are met: Amplitude: ±2 to ±700 mV Width: 0.1 to 2 ms Rise time: 10 to 100 μs Pulse rejection For heart rate meter, pulse is rejected if the requirements of ANSI/AAMI EC13:2002, Sect. 4.1.4.1 are met: Amplitude: ±2 to ±700 mV Width: 0.1 to 2 ms Rise time: 10 to 100 μs Heart rate Range ADU: 15 to 300 bpm PED/NEO: 15 to 350 bpm Accuracy ±1 % or ±1 bpm, whichever is greater Resolution 1 bpm - 109 - Instructions for Use Vista 120 Patient Monitor Sensitivity ≥300 μVPP PVC Range ADU: 0 to 300 PVCs/ min PED/NEO: 0 to 350 PVCs/ min Resolution 1 PVCs/min or 2% of measurement, whichever is greater ST value Range -2.0 to +2.0 mV Accuracy The max. of ±0.02 mV or 10% (-0.8 to +0.8 mV) Resolution 0.01 mV HR averaging method Method 1 Normally, heart rate is computed by averaging the 12 most recent RR intervals. Method 2 If each of three consecutive RR intervals is greater than 1200 ms, then the four most recent RR intervals are averaged to compute the HR. Range of sinus and SV rhythm Brady ADU: 120 to 300 bpm PED/NEO: 160 to 350 bpm Normal ADU: 41 to 119 bpm PED/NEO: 61 to 159 bpm Tachy ADU: 15 to 40 bpm PED/NEO: 15 to 60 bpm Range of ventricular rhythm Ventricular tachycardia The interval of 5 consecutive ventricular beats is less than 600 ms Ventricular rhythm The interval of consecutive ventricular beats ranges from 600 ms to 1000 ms Ventricular bradycardia The interval of 5 consecutive ventricular beats is more than 1000 ms Time to alarm for tachycardia Ventricular tachycardia Gain 1.0: 10 s 1 mV 206bpm Gain 0.5: 10 s Gain 2.0: 10 s - 110 - Instructions for Use Vista 120 Patient Monitor Ventricular tachycardia Gain 1.0: 10 s 2 mV 195 bpm Gain 0.5: 10 s Gain 2.0: 10 s Response time of heart rate meter to change in HR HR range: 80 to 120 bpm Range : 7 to 8 s, average is 7.5 s HR range: 80 to 40 bpm Range : 7 to 8 s, average is 7.5 s Tall T-wave rejection Exceeds ANSI/AAMI EC13:2002, Sect. 4.1.2.1 c) minimum recommended 1.2 mV T-Wave amplitude Accuracy of heart rate meter and response to irregular rhythm According with ANSI/AAMI EC13:2002, Sect.4.1.2.1 e) The HR value after 20s: Ventricular bigeminy: 80 ±1 bpm Slow alternating ventricular bigeminy: 60 ±1 bpm Rapid alternating ventricular bigeminy: 120 ±1 bpm Bidirectional systoles: 90 ±1 bpm 16 different arrhythmia analyses Non-paced patient Paced patient ASYSTOLE R on T ASYSTOLE VFIB/VTAC PVC TACHY COUPLET TACHY BRADY VT>2 BRADY PNC BIGEMINY MISSED BEATS PNP TRIGEMINY VWNT IRR VBRADY RESP Method Impedance between RA-LL, RA-LA Baseline impedance range 200 to 2500 Ω (cable resistance = 0 K) 2200 to 4500 Ω (leads cables 1KΩ resistance) Measuring sensitivity 0.3 Ω (baseline impedance 200 to 4500 Ω) Noise < 0.1 Ω (3, 5-lead monitoring) Max. dynamic range 500 Ω resistance, 3 Ω variable resistance, no clipping Waveform bandwidth 0.2 to 2.5 Hz (-3 dB) - 111 - Instructions for Use Vista 120 Patient Monitor RR measuring range: Adult 0 to 120 rpm Neo/Ped 0 to 150 rpm Resolution 1 rpm Accuracy ±2 rpm Gain selection ×0.25, ×0.5, ×1, ×2, ×3, ×4, ×5 Respiration excitation waveform < 400 μA, sinusoid, 62.8 kHz (± 10%) NIBP Method Oscillometric Mode Manual, Auto, Continuous Measuring interval in AUTO mode 1/2/3/4/5/10/15/30/60/90/120/240/480 min Continuous 5 min, interval is 5 s Measuring type Systolic Pressure, Diastolic Pressure, Mean Pressure Alarm type SYS, DIA, MAP Measuring and alarm rang Adult mode SYS: 40 to 270 mmHg DIA: 10 to 215 mmHg MAP: 20 to 235 mmHg Pediatric mode SYS: 40 to 200 mmHg DIA: 10 to 150 mmHg MAP: 20 to 165 mmHg Neonatal mode SYS: 40 to 135 mmHg DIA: 10 to 100 mmHg MAP: 20 to 110 mmHg Cuff pressure measuring range 0 to 300 mmHg Pressure resolution 1 mmHg Maximum standard deviation 8 mmHg - 112 - Instructions for Use Vista 120 Patient Monitor Maximum measuring period Adult/Pediatric 120 s Neonate 90 s Typical measuring period 30 to 45 s (depend on HR/motion disturbance) Overpressure protection (Dual overpressure protection) Adult 297 ±3 mmHg Pediatric 240 ±3 mmHg Neonatal 147 ±3 mmHg Measuring range 40 to 240 bpm Accuracy ±3 or 3.5%, whichever is larger PR SpO2 Measuring Range 0 to 100 % Alarm Range 0 to 100 % Resolution 1% Accuracy Adult (including Pediatric) ±2 % (70 to 100 % SpO2) Undefined (0 to 69 % SpO2) Neonate ±3 % (70 to 100 % SpO2) Undefined (0 to 69 % SpO2) Pulse Rate Measuring range 25 to 300 bpm Alarm range 30 to 300 bpm Accuracy ±2 bpm Data update period 1s Wave length Red light 660±3 nm Infrared light 905±5 nm - 113 - Instructions for Use Vista 120 Patient Monitor TEMP Channel 2 Measuring range 0 to 50 °C Alarm range 0 to 50 °C Sensor type YSI-10K Resolution +0.1 °C Accuracy (without sensor) ±0.1 °C Refresh time Every 1 to 2 s IBP Pressure measuring range -50 to +300 mmHg Resolution 1 mmHg Accuracy (without sensor) ± 2 % or ±1 mmHg, whichever is larger Pressure sensor Sensitivity 5 (μV/V/mmHg) Impedance 300 to 3000 Ω Frequency response d.c. to 12.5 or 40 Hz Zero Range: ±200 mmHg Accuracy: ±1 mmHg Measuring and alarm range Art 0 mmHg to 300 mmHg PA -6 to +120mmHg CVP/RAP/LAP/ICP -10 to +40 mmHg P1/P2 -50 to +300 mmHg Volume displacement of MSI 4.5 x 10-4 in3 / 100 mmHg CO2 Method Infra-red Absorption Technique Unit mmHg, %, kPa Measuring range EtCO2 0 to 150 mmHg - 114 - Instructions for Use Vista 120 Patient Monitor FiCO2 3 to 50 mmHg AwRR 0 to 150 rpm (MainStream) Resolution EtCO2 1 mmHg FiCO2 1 mmHg AwRR 1 rpm EtCO2 Accuracy ± 2 mmHg, 0 to 40 mmHg ± 5 % of reading, 41 to 70 mmHg ± 8 % of reading, 71 to 100 mmHg ± 10 % of reading, 101 to 150 mmHg AwRR Accuracy ± 1 rpm Apnea Alarm Delay 10 s, 15 s, 20 s (default), 25 s, 30 s, 35 s, 40 s Calculation Method BTPS (Body Temperature Pressure Saturated) Sample Gas Flowrate 50 ml/min Stability Short Term Drift Drift over 4 hours < 0.8 mmHg Long Term Drift 120 hour period O2 Compensation Range 0 to 100 % Resolution 1% Default 16 % Response time 60 ms - 115 - Instructions for Use Vista 120 Patient Monitor EMC Declaration General information The EMC compliance of the medical device is also applicable to the external cables, transducers, and accessories specified in the list of accessories. In addition, accessories which do not affect EMC compliance may be used if no other reasons forbid their use (see other sections of the Instructions for Use). The use of non-compliant accessories may result in increased emissions or decreased immunity of the medical device. The medical device may only be used adjacent to or stacked with other devices when the configuration is approved by Dräger. If adjacent or stacked use of non-approved configurations is inevitable, the medical device must be observed to verify normal operation in the said configuration. In any case, strictly observe the Instructions for Use of the other devices. Electromagnetic emissions When selecting wireless systems (wireless communication devices, pager systems, etc.) for use in installations where wireless networking is used, ensure that operating frequencies are compatible. Low-level signals such as ECG are particularly susceptible to interference from electromagnetic energy. While the equipment meets the testing described below, it will not ensure perfect operation. The ‘quieter’ the electrical environment the better. In general, increasing the distance between electrical devices decreases the likelihood of interference. Electromagnetic environment The medical device is intended for use in an electromagnetic environment as specified below. The user must ensure its use in such an environment. Emissions Radio frequency emissions (CISPR 11) Compliance according to Group 1 Class A Class A Harmonic emissions (IEC 61000-3-2) Voltage fluctuations/flicker Complies emissions (IEC 61000-3-3) - 116 - Electromagnetic environment The medical device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The medical device is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Instructions for Use Vista 120 Patient Monitor Electromagnetic immunity The medical device is intended for use in an electromagnetic environment as specified below. The user must ensure its use in such an environment. Immunity against Electrostatic discharge (ESD) (IEC 61000-4-2) Electrical fast transients/ bursts (IEC 61000-4-4) Surge on AC mains lines (IEC 61000-4-5) Power frequency magnetic field (50/60 Hz) (IEC 61000-4-8) Test level (IEC 60601-1-2) Contact discharge: ±6 kV Air discharge: ±8 kV Compliance level Power supply lines: ±2 kV Longer input / output lines: ±1 kV Common mode: ±2 kV Differential mode: ±1 kV 3 A/m Voltage dips and short interruptions on AC mains input lines (IEC 61000-4-11) Dip >95 %, 0.5 periods Dip 60 %, 5 periods Dip 30 %, 25 periods Dip >95 %, 5 seconds Radiated RF (IEC 61000-4-3) 80 MHz to 2.5 GHz: 3 V/m Electromagnetic environment Contact discharge: Floors should be wood, ±6 kV concrete or ceramic tile. If floors are covered Air discharge: with synthetic material, ±8 kV the relative humidity should be at least 30 %. Power supply lines: Mains power quality ±2 kV should be that of a Longer input / output typical commercial or hospital environment. lines: ±1 kV Common mode: Mains power quality ±2 kV should be that of a typical commercial or Differential mode: hospital environment. ±1 kV 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Dip >95 %, 0.5 Mains power quality periods should be that of a typical commercial or Dip 60 %, 5 periods hospital environment. If Dip 30 %, 25 periods Dip >95 %, 5 seconds the user of the medical device requires continued operation during mains power supply interruptions, it is recommended that the medical device be powered from an uninterruptible power supply or a battery. 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of Vista 120, including cables, than the recommended - 117 - Instructions for Use Vista 120 Patient Monitor Immunity against Conducted RF (IEC 61000-4-6) Test level (IEC 60601-1-2) 150 kHz to 80 MHz: 3 VRMS Compliance level 3 VRMS Electromagnetic environment separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance ⎡ 3 .5 ⎤ d =⎢ ⎥ P ⎣ V1 ⎦ ⎡ 3 .5 ⎤ d = ⎢ ⎥ P 80 MHz ⎣ E1 ⎦ to 800 MHz ⎡7⎤ d = ⎢ ⎥ P 800 ⎣ E1 ⎦ MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of equipment marked with the following symbol: - 118 - Instructions for Use Vista 120 Patient Monitor Immunity against Test level (IEC 60601-1-2) Compliance level Electromagnetic environment NOTE At 80 MHz and 800 MHz, the higher frequency range applies. NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 1 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Vista 120 is used exceeds the applicable RF compliance level above, Vista 120 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating Vista 120. 2 Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m. - 119 - Instructions for Use Vista 120 Patient Monitor Recommended separation distances to portable and mobile RF telecommunication devices The separation distances below are in accordance with IEC 60601-1-2. Rated maximum output power of transmitter Separation distance according to frequency of transmitter(m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz (W) ⎡ 3 .5 ⎤ d =⎢ ⎥ P ⎣ V1 ⎦ ⎡ 3 .5 ⎤ d =⎢ ⎥ P ⎣ E1 ⎦ ⎡7⎤ d =⎢ ⎥ P ⎣ E1 ⎦ 0.01 0.12 0.12 0.23 0.1 0.36 0.37 0.74 1 1.16 1.17 2.33 10 3.69 3.69 7.38 100 11.67 11.67 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. - 120 - Instructions for Use Vista 120 Patient Monitor Default settings This appendix documents the most important default settings of the monitor as it is delivered from the factory. Note: If the monitor has been ordered preconfigured to your requirements, the settings at delivery will be different from those listed here. Patient information default settings Patient information settings Patient type Adult Pace Off Alarm default settings Alarm settings Pause time 120 s Alarm Mute On Sensor off alarm On Alarm latch Off ECG default settings ECG settings ADU PED Alarm switch On Alarm record Off Alarm level Medium Alarm high limit 120 160 200 Alarm low limit 50 75 100 Pace Off Lead type 5 Leads Display Normal Filter Monitor Smart lead off Off Heart volume 3 - 121 - NEO Instructions for Use Vista 120 Patient Monitor ST analysis ADU ST analysis On Alarm switch Off Alarm level Medium Alarm record Off Alarm high limit (ST-X) 0.2 Alarm low limit (ST-X) -0.2 PED NEO X stands for I, II, III, aVR, aVL, aVF, V. ARR analysis ARR analysis Off PVCs alarm level Medium PVCs alarm switch Off PVCs alarm record Off ARR alarm settings Alarm switch Alarm level Alarm record ASYSTOLE On Medium Off VFIB/VTAC On Medium Off R ON T On Medium Off VT > 2 On Medium Off COUPLET On Medium Off PVC On Medium Off BIGEMINY On Medium Off TRIGEMINY On Medium Off TACHY On Medium Off BRADY On Medium Off MISSEDBEATS On Medium Off IRR On Medium Off PNC On Medium Off PNP On Medium Off VBRADY On Medium Off VENT On Medium Off - 122 - Instructions for Use Vista 120 Patient Monitor RESP RESP settings ADU PED NEO Alarm switch On Alarm record Off Alarm level Medium Alarm high limit 30 30 100 Alarm low limit 8 8 30 Apnea time 20 s Calculation type Auto Resp hold type Auto Sweep 12.5 mm/s Amplitude 1 PED NEO SpO2 SpO2 settings ADU Alarm switch On Alarm record Off Alarm level Medium Alarm high limit 100 100 95 Alarm low limit 90 90 88 Pitch tone Off Sweep 12.5 mm/s PED NEO PR PR settings ADU PR source SpO2 Alarm switch On Alarm record Off Alarm level Medium Alarm high limit 120 160 200 Alarm low limit 50 75 100 Pulse volume 3 - 123 - Instructions for Use Vista 120 Patient Monitor Alarm source Auto NIBP NIBP settings ADU PED NEO Alarm switch On Alarm record Off Alarm level Medium Alarm high limit (SYS) 160 120 90 Alarm low limit (SYS) 90 75 40 Alarm high limit (Mean) 110 90 70 Alarm low limit (Mean) 60 50 30 Alarm high limit (Dia) 90 70 60 Alarm low limit (Dia) 50 40 20 Inflation value 160 140 100 Unit mmHg Interval Manual PED NEO TEMP TEMP settings ADU Alarm switch On Alarm record Off Alarm level Medium Alarm high limit (T1) 39.0 39.0 39.0 Alarm low limit (T1) 36.0 36.0 36.0 Alarm high limit (T2) 39.0 39.0 39.0 Alarm low limit (T2) 36.0 36.0 36.0 Alarm high limit (TD) 2.0 2.0 2.0 Unit °C - 124 - Instructions for Use Vista 120 Patient Monitor IBP IBP settings ADU PED NEO Alarm switch On Alarm record Off Alarm level Medium Unit mmHg Filter 12.5 Hz SYS, DIA, MEAN SYS, DIA, MEAN SYS, DIA, MEAN Alarm high limit (ART, P1, P2) 160, 90, 110 160, 90, 110 160, 90, 110 Alarm low limit (ART, P1, P2) 90, 50, 70 90, 50, 70 90, 50, 70 Alarm high limit (PA) 35, 16, 20 35, 16, 20 35, 16, 20 Alarm low limit (PA) 10, 0, 0 10, 0, 0 10, 0, 0 MEAN MEAN MEAN Alarm high limit (CVP, RAP, LAP, ICP) 10 10 10 Alarm low limit (CVP, RAP, LAP, ICP) 0 0 0 CO2 CO2 settings ADU PED Alarm switch On Alarm record Off Alarm level Medium Work mode Measure Unit mmHg Apnea time 20 s O2 compensate 16 % Anes agent 0% Alarm high limit (EtCO2) 50 50 45 Alarm low limit (EtCO2) 15 20 30 - 125 - NEO Instructions for Use Vista 120 Patient Monitor Alarm high limit (FiCO2) 4 4 4 Alarm high limit (AWRR) 30 30 100 Alarm low limit (AWRR) 8 8 30 Sweep 12.5 mm/s Amplitude Low - 126 - Instructions for Use Vista 120 Patient Monitor - 127 - Instructions for Use Vista 120 Patient Monitor Passwords The following dialog boxes are protected by a password to prevent unauthorized changes: • • User Maintain Demo Mode The password can be found on this page of these Instructions for Use. Cut out this section and store it in a safe place to keep it from unauthorized persons. If the section with the password has been removed, ask the person responsible for the device about the possibility of making changes in the above mentioned dialog boxes. If the password is lost, contact DrägerService. Passwords for Vista 120 Cut out this section and store it in a safe place to keep it from unauthorized persons. The following dialog boxes are protected by a password to prevent unauthorized changes: Dialog box Password Menu > Maintenance > User Maintain ABC Menu > Common Function > Demo Mode 3045 - 128 - These instructions for use apply only to Vista 120 SW 1.n with the Serial No.: If no Serial No. has been filled in by Dräger, these Instructions for Use are provided for general information only and are not intended for use with any specific machine or unit. This document is provided for customer information only, and will not be updated or exchanged without customer request. Directive 93/42/EEC concerning Medical Devices Manufacturer: Dräger Medical GmbH Moislinger Allee 53-55 D-23542 Lübeck Germany +49 451 8 82-0 FAX +49 451 8 82-20 80 http://www.draeger.com 2606251 – GA 6498.020 enUS © Dräger Medical GmbH Edition: 3 – 2011-06 (Edition: 1 – 2010-12) Dräger reserves the right to make modifications to the equipment without prior notice.