Heyer Vizor 15 - Manual 1.0 en
Heyer Vizor 15 - Manual 1.0 en
PATIENT MONITORING
                 Operator’s Manual
                         Rev. 1.0 – 09/09
        Table of contents
        1    Details of the Manufacturer .......................................................................................................................... 5
        2    Introduction.................................................................................................................................................... 6
          2.1     General Warning...................................................................................................................................... 6
          2.2     General information ................................................................................................................................. 7
          2.3     Screen Display......................................................................................................................................... 9
          2.4     Button Functions.................................................................................................................................... 10
          2.5     Interfaces............................................................................................................................................... 11
          2.6     Built-in Battery ....................................................................................................................................... 13
        3    Configuration ............................................................................................................................................... 14
          3.1     SIGMA ................................................................................................................................................... 14
          3.2     TREND .................................................................................................................................................. 14
          3.3     ALARM .................................................................................................................................................. 16
          3.4     SETUP................................................................................................................................................... 16
          3.5     PATIENT INFORMATION ..................................................................................................................... 17
          3.6     RECORDER .......................................................................................................................................... 17
          3.7     ABOUT .................................................................................................................................................. 18
        4    Alarm ............................................................................................................................................................ 19
          4.1     Alarm Modes ......................................................................................................................................... 19
             4.1.1      Alarm Level And Setup .................................................................................................................. 19
          4.2     Alarm Modes ......................................................................................................................................... 19
          4.3     Alarm Verification During Power On ...................................................................................................... 19
          4.4     Alarm Cause.......................................................................................................................................... 19
          4.5     Alarm Silence Button Function .............................................................................................................. 19
          4.6     Parameter Alarm.................................................................................................................................... 19
          4.7     When An Alarm Occurs ......................................................................................................................... 20
        5    ECG Monitoring ........................................................................................................................................... 21
          5.1     General.................................................................................................................................................. 21
          5.2     ECG Window ......................................................................................................................................... 24
          5.3     ECG Alarm Message ............................................................................................................................. 25
          5.4     ECG Cable Cleaning ............................................................................................................................. 26
        6    RESP Monitoring ......................................................................................................................................... 27
          6.1     General.................................................................................................................................................. 27
          6.2     RESP Window ....................................................................................................................................... 27
          6.3     RESP Alarm Message ........................................................................................................................... 28
        7    SpO2 Monitoring .......................................................................................................................................... 29
          7.1     General.................................................................................................................................................. 29
          7.2     SpO2 Window ........................................................................................................................................ 32
          7.3     SpO2 Alarm Message ............................................................................................................................ 33
          7.4     SpO2 Probe Cleaning ............................................................................................................................ 33
        8    NIBP Monitoring .......................................................................................................................................... 34
          8.1     General.................................................................................................................................................. 34
          8.2     NIBP Window ........................................................................................................................................ 36
          8.3     NIBP Alarm Message ............................................................................................................................ 37
          8.4     NIBP Cuff Cleaning................................................................................................................................ 37
        9    TEMP Monitoring ......................................................................................................................................... 38
          9.1     General.................................................................................................................................................. 38
          9.2     TEMP Window....................................................................................................................................... 38
          9.3     TEMP Alarm Message........................................................................................................................... 39
          9.4     TEMP Sensor Cleaning And Storage .................................................................................................... 39
        10 IBP Monitoring ............................................................................................................................................. 40
          10.1       General.............................................................................................................................................. 40
          10.2       IBP Window ....................................................................................................................................... 41
          10.3       IBP Alarm Message ........................................................................................................................... 43
          10.4       IBP Transducer Cleaning................................................................................................................... 44
        11 GAS Monitoring (Mainstream) .................................................................................................................... 45
          11.1       General.............................................................................................................................................. 45
          11.2       GAS Window ..................................................................................................................................... 49
          11.3       GAS Alarm Message ......................................................................................................................... 52
          11.4       IRMA Sensor Cleaning ...................................................................................................................... 53
        12 Cerebral State Monitoring........................................................................................................................... 54
          12.1       General.............................................................................................................................................. 54
          12.2       CSM On Patient Monitor.................................................................................................................... 54
        13 ST Monitoring .............................................................................................................................................. 56
          13.1       General.............................................................................................................................................. 56
          13.2       ST Analysis Window .......................................................................................................................... 56
          13.3       ST Alarm Message ............................................................................................................................ 58
         14 ARRYTHMIA Monitoring.............................................................................................................................. 58
           14.1    General.............................................................................................................................................. 58
           14.2    ARR ANALYSIS Window................................................................................................................... 59
         15 RECORDING................................................................................................................................................. 62
           15.1    General.............................................................................................................................................. 62
           15.2    Recording Type ................................................................................................................................. 62
           15.3    Recorder Operation And Status Messages ....................................................................................... 62
           15.4    Recorder Paper ................................................................................................................................. 63
           15.5    Recorder Status Message ................................................................................................................. 63
           15.6    Recorder Cleaning............................................................................................................................. 63
         16 Patient Safety............................................................................................................................................... 64
         17 Care And Cleaning ...................................................................................................................................... 65
           17.1    Cleaning ............................................................................................................................................ 65
           17.2    Sterilization ........................................................................................................................................ 65
           17.3    Disinfection ........................................................................................................................................ 65
         18 Getting Started............................................................................................................................................. 66
           18.1    Open The Package And Check ......................................................................................................... 66
           18.2    Place The Battery Fuse ..................................................................................................................... 66
           18.3    Connect The Power Cables............................................................................................................... 66
           18.4    Power On The Monitor....................................................................................................................... 66
           18.5    Connect Patient Sensors ................................................................................................................... 66
         19 Technical Specification............................................................................................................................... 67
         20 Trouble Shooting......................................................................................................................................... 71
         21 Warranty....................................................................................................................................................... 72
         APPENDIX I .......................................................................................................................................................... 73
         APPENDIX II ......................................................................................................................................................... 76
         APPENDIX III ........................................................................................................................................................ 81
                                            E-Mail: info@heyermedical.de
                                            Internet: http://www.heyermedical.de
         2     Introduction                                             Warning
                                                                     To prevent EMC effect on the monitor, the
         ■ For an overall safety instruction, please refer           system should not be used adjacent to or
           to 2.1 General Warning.                                   stacked with other equipment and that if
         ■ For an overall introduction to the monitor,               adjacent or stacked use is necessary, the
           please refer to 2.2 General Information.                  equipment should be observed to verify normal
         ■ For various messages displayed on the                     operation in the configuration in which it will be
           screen, please refer to 2.3 Display Screen.               used.
         ■ For basic operating instructions, please refer
                                                                       Warning
           to 2.4 Button Function And Basic
                                                                     The user must check that equipment and
           Operation.
                                                                     accessories function safely and see that it is in
         ■ For allocation of interface sockets, please
                                                                     proper working condition before being used.
           refer to 2.5 Peripheral Interfaces.
         ■ For important facts to be noted during the                   Warning
           battery recharging procedure, please refer to             Alarm must be set up according to different
           2.6 Built-in Rechargeable Battery.                        situation of individual patient. Make sure that
                                                                     audio sounds can be activated when alarm
         2.1    General Warning                                      occurs.
           Warning                                                     Warning
         Portable Patient Monitor is intended for clinical           Do not use cellular phone in the vicinity of this
         monitoring application with operation only                  equipment. High level of electromagnetic
         granted to appropriate medical staff.                       radiation emitted from such devices may result
                                                                     in strong interference with the monitor
            Warning                                                  performance.
         Before use, carefully read this manual,
         directions for use of any accessories, all                    Warning
         precautions, and all specifications.                        Do not touch the patient, table nearby, or the
                                                                     equipment during defibrillation.
           Warning
         The vital sign monitor is intended for use only                Warning
         as an adjunct in patient assessment .It must be             The equipment and devices connected to it
         used in conjunction with clinical signs and                 should form an equipotential body to ensure
         symptoms.                                                   effective grounding.
             Warning                                                    Warning
         If the accuracy of any measurement does not                 The doctor shall consider all well-known side-
         seem reasonable, first check the patient's vital            effects when using the patient monitor.
         signs by alternate means and then check the
                                                                        Warning
         monitor for proper functioning.
                                                                     There will be some risks of polluting the
            Warning                                                  environment associated with the disposal of
         Do not use the patient monitor during magnetic              the device and cables at the end of their useful
         resonance imaging (MRI) scanning. Induced                   lives. The device and accessories shall be
         current could potentially cause burns. The                  disposed in accordance with national laws after
         monitor may affect the MRI image, and the                   their useful lives. Contact your municipality to
         MRI unit may affect the accuracy of monitor                 check where you can safely dispose of old
         measurements.                                               batteries.
           Warning                                                     Warning
         Do not place the monitor in any position that               Do not expose the system near any local
         might cause it to fall on the patient.                      heating item such as the direct radiation.
            Warning                                                     Warning
         There could be hazard of electrical shock by                Do not use one monitor for two or more patient
         opening the monitor casing. All servicing and               at the same time.
         future upgrading to this equipment must be                      Warning
         carried out by personnel trained and
                                                                     It is possible to increase leakage current when
         authorized by manufacturer.
                                                                     several systems are connected to the patient
            Warning                                                  simultaneously.
         Equipment not suitable for use in the presence
         of a flammable anesthetic mixture with air or
         with oxygen or nitrous oxide.
          Warning
        Monitor software is designed in a way that
        hazards arising from errors in the software
        programmed are minimized.
           Warning
        Do not connect items not specified as parts of
        the monitor.
           Warning
        Vital sign monitor needs to be installed and put
        into service according to the EMC information
        provided in the APPENDIX III
        General instruction:
        Portable Patient Monitor (Figure 1) is
        adaptable to adult and neonatal usage. It can
        monitor vital signals as ECG, Respiratory Rate,
        SpO2, NIBP, Dual IBP, CO2, O2, N2O,
        Anesthesia Agent, Dual-TEMP and Cerebral
        State Index .It integrates parameter measuring
        modules, display and recorder in one device,
        featuring in compactness, lightweight and
        portability.    Built-in    battery   facilitates
        transportation of patient. Large high-resolution
        display provides clear view of waveforms.
        The POWER switch is on the front panel ( in
        Figure 1). Three indicators for power and alarm
        and battery are on the front panel of system.
        The green indicator lights, when the device is
        powered on (       in Figure 1). The ALARM
        indicator, flashes or lights when alarm occurs
        ( in Figure 1).The battery indicator is green,
        when the battery is charged otherwise it is
        orange. ( in Figure 1). The sockets of the
        sensors are at the left side of system. Other
        sockets and power plug-in are at the back.
           Warning
        During the system is powered on, the
        indicators light. If all indicators light, it will show
        proper functioning of all indicators.
         Portable patient monitor performs monitoring                    Vital sign monitor provides extensive functions
         of:                                                             as visible & audible alarm, storage and report
                                                                         printout, trend data, NIBP measurements
         ECG                   Heart Rate (HR)                           Depending on customer's order, MASIMO or
                               ECG Waveforms                             STANDARD modules can be installed on vital
         RESP                  Respiratory Rate (RR)                     sign monitor optionally.
                               Respiration Waveform                      Depending on customer's order, mainstream or
         SpO2                  Saturation Pulse oximetery                sidstream CO2 module can be installed on
                               (SpO2), Pulse Rate (PR)                   system optionally.
                               SpO2 Plethysmogram                        Vital sign monitor is a user-friendly device with
         NIBP                  Systolic Pressure, Diastolic              operations conducted by a few buttons on the
                               Pressure, Mean Arterial                   front panel and a rotary knob. Refer to 2.4
                               Pressure (MAP)                            Button Functions for details.
         TEMP                  Channel-1 Temperature (T1),
                               Channel-2 Temperature (T2),
                               Differential Temperature
                               between two channels (DT)
         IBP                   Channel-1 IBP (IBP1), Channel-
                               2 IBP (IBP2)
         CO2                   EtCO2, FiCO2, AWRR
         Multi-gas             EtN2O, FiN2O, EtO2, FiO2,
                               EtAA, FiAA
                               AA is included 5 anesthesia
                               agent (DES, ISO, SEV, HAL,
                               ENF)
         CSM                   CSI%, BS%, SQI%, EMG%
        2.3        Screen Display                                 The size of the menu is also fixed, covering the
                                                                  lowest 2, 3, 4 or 5 waveforms.
        Vital sign monitor has a color TFT display. The
        patient    Parameters,     waveforms,     alarm           Parameter Area
        messages, bed number, date, system status                 Parameters are displayed at a fixed position.
        and error messages is displayed on the                    The monitoring results are displayed in the
        screen.                                                   Parameter Area. The parameters refresh every
        The screen is divided into three areas: Header            second, except that the NIBP values refresh
        Area; Waveform Area; Parameter Area (Figure               each time the measurement is over.
        2)
                                                                  Alarm indicator:
                                                                  In normal mode, the alarm indicator is not lit.
                                                                  In alarm mode, the alarm indicator lights or
                                                                  flashes.
                                                                     Warning
                                                                  Always verify the audible and visible (LED)
                                                                  alarms when monitor powers on.
                                                                  Please refer to chapter 4 for details.
        Header Area:
        The Header Area is at top of the screen
        displaying operating state of the monitor and
        status of the patient.
        The parameters in Header Area are bed
        number, type of patient (adult or neonate),
        current date and time
        The above messages appear on the screen
        throughout the monitoring process.
        Other information of the Header Area comes
        up only with respective monitoring status.
        They are:
         ■       Signs indicating the remaining battery
            charge
         ■ "ALARM SILENCE" appears when the
            alarm silence button is pressed.
         ■ "NETWORK" appears when the system is
            connected to central system.
        Waveform / Menu Area:
        All waveforms can be displayed at the same
        time. The waveforms from top to bottom are:
        ECG, SpO2, IBP1, IBP2, EEG (for 12’’ or
        larger) and RESP/CO2/Multi-gas (coming from
        ECG module or CO2 module or Multi-gas
        module).
        Gain, filter and lead of the ECG are displayed
        as well .The three dotted lines from top to
        bottom show the highest scale, reference scale
        and lowest scale of IBP waveform. These
        values can be manually set.
        All menus in monitor always appear at fixed
        areas on the screen. When the menu is
        displayed, some waveforms become invisible.
          2.4     Button Functions                                    When you move the cursor to a certain item:
                                                                         1. A menu pops up, by pressing the
          All the operations to monitor are executed                        knob.
          through buttons and knob at the right of the                   2. You can move the cursor frame to
          front panel. The names of the buttons are                         related parameter in opened menu by
          above them. They are (Figure 3):                                  turning the knob.
                Rotary Knob                                              3. You can change the content by
                This knob can be used to select and                         pressing the knob on the special
                change settings. Operations can be                          parameters and choose your setting
                performed by turning clockwise, counter                     and confirm your selection by pressing
                clockwise or pressing it down. The square                   it.
                frame that moves with the knob turning is               Warning
                referred to as “cursor”.                              Before using the system on the patient, the
                                                                      user must check the buttons function and be
                Power
                                                                      sure that it is in proper working functionality as
                Press to power on or off the system.
                                                                      described above.
                HOME/MENU
                Press to call up the HOME WINDOW.
                Refer to chapter 3 HOME WINDOW.
                START/STOP
                Press to inflate the cuff to start a blood
                pressure measurement. When measuring,
                press again to stop the measurement and
                deflate the cuff.
                REC/STOP
                Press to start a real time recording from
                ECG signal and all monitoring parameters.
                Press during recording to stop the
                recording f.
                Freeze
                When in normal mode, press to freeze all
                waveforms on the screen. When in freeze                Fig. 3 - Monitor’s buttons and knob
                mode, press to restore the waveform
                refreshing.
          NOTE:
          If new alarm occurs under Alarm Suspension /
          Silence state, Suspension / Silence state will
          remove.
                Alarm Silence
                Press to suspend alarm for 120 seconds
                and disable all sound signals.
                ("ALARM SILENCE" appears in the
                Header Area). Press this key again to
                restore all sound signals and remove the
                message.
          .
          When no menu is displayed, turning the knob
          clockwise can locate the cursor at: ECG, NIBP,
          SpO2, IBP, EEG and RESP/CO2/Multi gas
          Parameter Area of screen.
          When the cursor is placed at any area, the
          user can change the current setting. When at
          any of the last items, related parameters menu
          can be called up for setting changes.
          Operation is as follows:
        2.5        Interfaces
        For the verity of operation, different kinds of
        interfaces are in different parts of the monitor.
        At the right side is the recorder's paper inlet
        cover (if the system has a recorder).
        At the left side are the connectors to patient
        cables and the sensors, as shown in figure 4.
          Warning
                                                                               This symbol means "BE CAREFUL". Refer to
        For STANDARD SpO2, the shape of ECG and                                the manual.
        SpO2 connectors are the same. The user
        should be note to place the ECG and SpO2                               Indicates that the instrument is IEC-601-1 Type
        cables in corresponding connectors.                                    CF equipment. The module with this symbol
                                                                               contains an F-Type isolated (floating) patient
            Warning                                                            applied part providing a high degree of
                                                                               protection against shock, and is usable during
        It is essential that white sign of ECG connector                       defibrillation.
        on the side panel should be in front of the
        white sign of the ECG cable connector.                                 Indicates that the instrument is IEC-601-1 Type
                                                                               BF equipment which is defibrillator proof. The
           Warning                                                             module with this symbol contains an F-Type
        For STANDARD SpO2, that white sign of SpO2                             isolated (floating) patient applied part which
                                                                               contains an adequate degree of protection
        connector on the side panel should be in front                         against shock, and is suitable for use during
        of the white sign of the SpO2 probe connector.                         defibrillation.
                                                                                 Warning
                                                                              If DC-INPUT power supply in cars like
                                                                              ambulances is used (ambulances with
                                                                              body that is connected to the negative pole
                                                                              of the battery), for safety requirements, DC
                                                                              to DC converter with the isolation of
                                                                              1500VAC (at least), must be used. Using
                                                                              220V of power supply in ambulances is
                                                                              recommended. Preparing mentioned DC to
                                                                              DC converter, please contact technical
          Fig. 5 - Rear panel
                                                                              department of manufacturer.
          How to use:
          1. Install the VGA slave monitor in the same
             room with the patient but keep it away from
             the patient for more than 1.5m. The
             monitor is intended to be used as an
             assistant monitoring device.
          3     Configuration
          ■     For last saved ECG signal, please refer to
                3.1 SIGMA
          ■     For    previous   value     of   measured
                parameters, please refer to 3.2 TREND.
          ■     For alarm setting and a alarm volume
                adjustment, please refer to 3.3 ALARM
                                                                       Fig. 6 - HOME window
          ■     For date and time setting please refer to
                3.4 SETUP
          Portable patient monitor features flexible
          configurations. The configuration is done
          through operations on the HOME WINDOW
          (figure 6) by pressing the HOME/MENU button
          on the front panel of monitor.
          3.1     SIGMA
          Patient monitor is able to save at the last 160
          second ECG signal and it is visible in 10 trace
          in SIGMA WINDOW.
          Pick "SIGMA" in HOME WINDOW to call up
          the following menu: ⇒
          In this window there are ECG current settings,
          like ECG LEAD, ECG GAIN and SIGMA
          SWEEP.       Refer   to   chapter  5     ECG
          MONITORING for details.
                                                                      CALENDAR
                                                                      Available options are "SOLAR" and
                                                                      “CHRISTIAN".
                                                                      DATE
          Fig. 8 - Alarm window                                       Set the current date of monitoring
          ■     PERIODIC TRACE1
                Choose the first trace of print out record
                while automatic recording.
                Available options are ECG, SpO2, IBP1,
                IBP2 and RESP
          ■     PERIODIC TRACE2
                Choose the second trace channel of print
                out record while automatic recording.
                Available options are ECG, SpO2, IBP1,
                IBP2, RESP and OFF.
          ■     PERIODIC INTERVAL
                For choosing interval time in periodic
                recording mode .Available selections are
                15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h and
                OFF.
          ■     ALARM RECORD
                While alarm recording for each parameter
                is set ON, it automatically starts recording
                when alarms happened.
          3.7     ABOUT
          After choosing "ABOUT" in HOME WINDOW
          menu, the following menu will be called up:
                                                                                   NOTE:
                                                                                   To ensure patient safety, all leads must be
                                                                                   attached to the patient.
                    S (660) = S1 + N1                                 NOTE:
                    S (905) = S2 + N2                                 A pulseoximetry is a early warning device.
                    R= S1 / S2                                        Use lab co-oximeter to understand the
                                                                      patient's condition completely.
          Again, R is the ratio of two arterial pulse-added
          absorbance signals and its value is used to                    Warning
          find the saturation SpO2 in an empirically                  Use only the recommended manufacturer
          derived equation into the oximeter's software.              SpO2 sensor for monitoring. Other SpO2
          The values in the empirically derived equation              sensors may cause improper monitor
          are based upon human blood studies against a                performance.
          laboratory co-oximeter on healthy adult
          volunteers in induced hypoxia studies.                         Warning
                                                                      Regarding    the    selected    module,  use
                                                                      accessories specified for each SpO2 module.
          The above equations are combined and a
          noise reference (N') is determined:                            Warning
                                                                      While choosing sensor, consider sensor
                     N' =S (660) - S (905) × R                        direction for use, written on the package such
                                                                      as patient's age and weight or if the sensor is
          If there is no noise N' = 0: then S (660) = S               reusable or disposable.
          (905) × R which is the same relationship for
          the traditional pulse oximeter.                                 Warning
                                                                      Pulseoximetry can overestimate the SpO2
                                                                      value in the presence of Hb-CO, Met-Hb or dye
          The equation for the noise reference is based
                                                                      dilution chemicals.
          on the value of R, the: value being seeked to
          determine the SpO2. The MS-7 software                          Warning
          sweeps through possible values of R that                    ESU wire and SpO2 cable must not be tangled
          correspond to SpO2 values between 1% and.                   up.
          100% and generates an N' value for each of
          these R values. The S (660) and S (905)                        Warning
          signals are processed with each possible N'                 Do not use the sensor on extremities with
          noise     reference  through    an    adaptive              arterial catheter or venous syringe.
          correlation canceller (ACC) which yields an
          output power for each possible value of R (i.e.,            SpO2 measurement
          each possible SpO2 from 1% to 100%). The
          result is a Discrete Saturation Transform                   1. Turn on the monitor.
                TM
          (DST ) plot of relative output power versus                 2. Attach the sensor to the appropriate site of
          possible SpO2 value as shown in the following                  the patient finger. Refer to Figure 24 for the
          figure where R corresponds to SpO2 = 97%:                      proper method.
                                                                      3. Plug the connector of the sensor extension
                                                                         cable into the SpO2 socket on the left side of
                                                                         the device.
                                                                          Warning
                                                                      High ambient light sources such as surgical
                                                                      lights (especially those with a xenon light
                                                                      source), bilirubin lamps, fluorescent lights,
                                                                      infrared heating lamps and direct sunlight can
                                                                      interfere with the performance of an SpO2
                                                                      sensor. To prevent interference from ambient
                                                                      light, ensure that the sensor is properly applied
                                                                      .and cover the sensor site with opaque
                                                                      material. Failure to take this action in high
          Fig. 23 - MASIMO energy output                              ambient light conditions may result in
                                                                      inaccurate measurements.
          The DST plot has two peaks: the peak
          corresponding to the higher saturation is                   NOTE:
          selected as the SpO2 value. This entire                     SpO2 module updates SpO2 parameter
          sequence is repeated once every two seconds                 every 1 sec.
          on the most recent four seconds of raw data.
          The MS'-7 SpO2 therefore corresponds to a
          running average of arterial hemoglobin
          saturation that is updated every two seconds.
          NIBP Measuring
                                                                      NOTE:
             Warning                                                  The width of the cuff should be either 40%
          ■ Before starting a measurement, verify that                of the limb circumference (50% for
            you have selected a setting appropriate for               neonates) or 2/3 of the upper arm length.
            your patient (adult or neonate.)                          The inflatable part of the cuff should be
          ■ Do not apply the cuff to a limb that has an               long enough to encircle 50-80% of the limb.
            intravenous infusion or catheter in place.                The wrong size of cuff can cause
            This could cause tissue damage around the                 erroneous measurement. If the cuff size is
            catheter when infusion is slowed or blocked               in question, then use a larger cuff.
            during cuff inflation.
        3. Connect the cuff to the air hose. The limb               Measurement Limitations
           chosen for taking the measurement should                 In different patient conditions, the oscillometric
           be placed at the same level as the patient's             measurement has certain limitations. The
           heart.                                                   measurement is in search of regular arterial
                                                                    pressure pulse. In those circumstances, when
        4. Check whether the patient mode is                        the patient's condition makes it difficult to
           appropriately selected. To change the                    detect, the measurement becomes unreliable
           patient mode, choose SETUP from the                      and measuring time increases. The user
           HOME WINDOW, the HOME/SETUP                              should be aware that the following conditions
           WINDOW menu will pop up. Pick                            could interfere the measurement and make the
           ADULT/NEONATE to make necessary                          measurement unreliable or longer. In some
           changes.                                                 cases, the patient's condition will make a
        5. Select a measurement mode in the NIBP                    measurement impossible.
           WINDOW menu. Refer to the following                      ● Patient Movement
           instructions, "Operation Hints", for details.            Measurements will be unreliable or may not be
        6. Press the START/STOP button on the front                 possible if the patient is moving, shivering or
           panel to start a NIBP measurement.                       having convulsions. These motions may
                                                                    interfere the detection of the arterial pressure
        Operation Hints                                             pulses. In addition, the measurement time will
                                                                    be prolonged.
        1. To start a MANUAL measuring:
           Press the START/STOP button on the front                 ● Cardiac Arrhythmia's
           panel                                                    Measurements will be unreliable and may not
                                                                    be possible if the patient's cardiac arrhythmia
        2. To stop a MANUAL measuring                               causes an irregular heart beat. Thus the
           Repress the START/STOP button on the                     measuring time will be prolonged.
           front panel
                                                                    ● Heart-lung Machine
        3. To start AUTO measuring:                                 Measurements will not be possible if the
           Select NIBP WINDOW menu and pick AUTO                    patient is connected to a heart-lung machine.
           for measuring interval setting, then press
           START/STOP button on the front panel.                    ● Pressure Changes
                                                                    Measurements will be unreliable and may not
           Warning                                                  be possible if the patient's blood pressure
        Prolonged    non-invasive     blood    pressure             changes rapidly over the period of time during
        measurements in Auto mode may be                            which the arterial pressure pulses are being
        associated with ischemia and neuropathy in                  analyzed to obtain the measurement.
        the limb wearing the cuff. When monitoring a
        patient, examine the limb frequently for normal             ● Severe Shock
        color, warmth and sensitivity. If any                       If the patient is in severe shock or
        abnormality is observed, stop the blood                     hypothermia, measurements will be unreliable
        pressure measurements.                                      because of reduced pulsation of the arteries.
          ■ NIBP UNIT
            Pick this item to adjust measurement unit
            (Options: mmHg or kPa).
          ■ ALARM LEVEL
            Selectable between 1 and 2. Level 1
            represents the most serious case.
          ■ NIBP ALARM
            Pick "ON" to enable NIBP alarm functions                  Fig. 29 - NIBP list window
            such as parameters blinking, audio alarm
            and light indicator. Pick "OFF" to disable the              By pressing the first left item you can select
            alarm functions and there will be a                         a line of NIBP recorded data and you will be
            " "symbol instead of alarm limits in                        able to delete a line of data in NIBP LIST by
            Parameters Area.                                            pressing the "DELETE" (second left item).
          ■ SYS LIMIT                                                ■ MODULE CHECK
            SYS alarm is activated when the systolic                   Available options are "NIBP MANOMETER",
            pressure exceeds adjusted ALARM HIGH                       "NIBP LEAKAGE", "MODULE SELF TEST",
            value or falls below adjusted ALARM LOW                    "MODULE STOP".
            value (min: 30 and max: 240).
                                                                     NIBP MANOMETER
          ■ DIA LIMIT                                                Wrap the cuff around a rigid cylinder. Connect
            DIA alarm is activated when the diastolic                a calibrated reference manometer and a ball
            pressure exceeds adjusted ALARM HIGH                     pump by means of a T-piece connector and
            value or falls below adjusted ALARM LOW                  hoses to the monitor. Set the monitor in "NIBP
            value (min: 20 and max: 180).                            MANOMETER" mode. Inflate the pneumatic
                                                                     system to 0, 50 and 200 mmHg by ball pump
          ■ MAP LIMIT
                                                                     separately. The difference between the
            MAP alarm is activated when the mean
                                                                     indicated pressure of the reference manometer
            arterial pressure exceeds adjusted ALARM
                                                                     and the indicated pressure of the monitor
            HIGH value or falls below adjusted ALARM
                                                                     should not exceed ±3 mmHg.
            LOW value (min: 25 and max: 200).
                                                                     NIBP LEAKAGE
                                                                     Wrap the cuff around a cylinder of an
                                                                     appropriate size, and the circumference of the
                                                                     applied cuff does not exceed that of the
        cylinder more than 7%. Set the monitor in                                         8.4     NIBP Cuff Cleaning
        "NIBP LEAKAGE" mode.
        The monitor inflates the cuff up to 170mmHg                                          Warning
        and keeps it constant for 15 sec. If air leakage                                  Do not press the cuff and tubing with a hot
        result is satisfactory, "NIBP LEAK OK"                                            iron.
        message is displayed; otherwise you will                                          ■ Cleaning
        receive "PNUMATIC LEAK" message.                                                    Durable one-piece cuffs may be safely
        NOTE:                                                                               cleaned with a damp cloth (70% alcohol or
        These test must only done by personnel                                              0.5% bleach solution may be used) or
        trained and authorized by manufacturer.                                             washed in water (140ºF, 60ºC maximum)
                                                                                            with soap or detergent.
        8.3        NIBP Alarm Message                                                     ■ Sterilization
                                                                                            Do not use steam or heat to sterilize the cuff.
        Alarm occurs when the pressure (SYS. DIA or                                         Gas sterilization may be used if necessary.
        MAP) exceeds the alarm limit
                                                                                          ■ Disinfection
                                                                        Audio
           Alarm             Situation            Visual prompt
                                                                        sound
                                                                                            Glutaraldehyde type liquid disinfectants may
                       SYS violates             ● SYS value                                 be used on durable cuffs. Prolonged used of
                       adjusted alarm limits      blinks
         SYS ALARM
                       or violates lower than   ● alarm indicator
                                                                       Activated            these disinfectants at full strength may cause
                       50mmHg                     flashes.
                                                ● DIA value
                                                                                            discoloration of the white cuff marking.
                       DIA violates adjusted      blinks
         DIA ALARM                                                     Activated
                       alarm limits             ● alarm indicator
                                                  flashes.
                       MAP violates             ● MAP value
                       adjusted alarm limits      blinks
        MAP ALARM                                                      Activated
                       or violates lower than   ● alarm indicator
                       30mmHg                     flashes.
Message Cause
                                                                               ■ IBP1/IBP2 ALARM
                                                                                 Pick "ON" to enable alarm functions such as
         Fig. 32 - IBP window                                                    parameters blinking, audio alarm and light
                                                                                 indicator. Pick "OFF" to disable the alarm
                                                                                 functions and there will be a " " symbol
        ■ IBP1/IBP2 UNIT
                                                                                 instead of alarm limits in Parameters Area.
          Pick this item to adjust measurement unit.
          (Options: mmHg, kPa, cmH2O)                                          ■ IBP1/IBP2 ALARM LEVEL
                                                                                 Selectable between 1, 2. Level 1 represents
        ■ IBP1/IBP2 LABLE
                                                                                 the most serious case.
          Suitable label should be selected, regarding
          the place of measurement. The available                              ■ SYS LIMIT
          pressure labels are:                                                   SYS alarm is activated when the systolic
                                                                                 pressure exceeds adjusted ALARM HIGH
                   Label        Definition
                   ART          Arterial Blood Pressure
                                                                                 value or falls below adjusted ALARM LOW
                   LVP          Left Ventricle Pressure                          value.
                   PAP          Pulmonary Artery Pressure
                   RVP          Right Ventricle Pressure
                   CVP          Central Venous Pressure
                                                                               ■ DIA LIMIT
                   LAP          Left Atrium Pressure                             DIA alarm is activated when the diastolic
                   RAP          Right Atrium Pressure
                                                                                 pressure exceeds adjusted ALARM HIGH
                                                                                 value or falls below adjusted ALARM LOW
           Warning
                                                                                 value.
        IBP algorithm will vary according to the
        selected label. Therefore in the case of                               ■ MEAN LIMIT
        improper label selecting, the accuracy of the                            MEAN alarm is activated when the mean
        measurement may be decreased.                                            pressure exceeds adjusted ALARM HIGH
                                                                                 value or falls below adjusted ALARM LOW
        ■ IBP SWEEP
                                                                                 value.
          Available options for IBP SWEEP are 3, 6,
          12.5 and 25mm/s.                                                     NOTE:
                                                                               The alarm High/Low limits for SYS, DIA and
        ■ IBP GRID
                                                                               MEAN of ART, LVP, PAP, RVP, CVP, LAP,
          Select "ON" to divide each IBP signal to 5
                                                                               RAP are listed as follow. Note that the CVP,
          parts with white dot lines.
                                                                               LAP and RAP only have MEAN pressure,
        ■ IBP FILTER                                                           therefore the alarm limit are only for MEAN.
          In order to have a more clear and detailed
                                                                               The alarm occurs when the value exceeds the
          waveform, 3 filter types can be selected:
                                                                               set limits.
          Available options are 22Hz, 16Hz, and 8Hz.
          22Hz: Recommended in normal use and the                                             Min Alarm High   Min Alarm High     Step
                                                                                  Lable
          most clinical situation. It has the most                                               (mmHg)           (mmHg)        (mmHg)
                                                                                  IBP               -50             300            5
          measuring accuracy among the called filters.                            ART               -50             300            5
          16Hz: When the signal is a bit noisy.                                   LVP               -50             300            5
                                                                                  PAP               -50             120            1
          8Hz: This mode is recommended to reduce                                 RVP               -50             100            1
                                                                                  CVP               -50             100            1
          noise and interface resulted from ESU and                               LAP               -50             100            1
          also when the system has a high noise level                             RAP               -50             100            1
          or doesn’t have equipotential earth. While
          using this filter the measuring accuracy
          might be decreased.
        ■ ALARM
          Pick "IBP ALARM" in IBP WINDOW to call
          up the following menu:
          NOTE:
          Since transducers need to be warmed to
          achieve   the     best   accuracy it is                   Fig. 35 - IBP / calib window
          recommended to zero the system at least
          15 minutes after connecting the IBP
          transducer to the system.
          NOTE:
          Zero procedure should be performed before
          starting the monitoring and at least once a
          day    after  each    disconnection    and
          connection of the cable.
           Zero the transducer:
           1 The transducer should be placed at mid-
             heart level.
           2 Turn off patient stopcock.
           3 The transducer must be vented to
             atmospheric pressure.
                                                                    Fig. 36 - IBP calibration
           4 Select < IBP1/IBP2 ZERO > to start
             zeroing procedure for each channel.
        7. Press the rotary knob to start the                                      in this state.              ● Follow hospital
                                                                                   This message can be           procedure for
           calibration.                                                            caused by the                 dislodging
                                                                                   following reason:             catheter.
        The message "PLEASE WAIT" will display                                     ● A physiological
                                                                                     condition e.g.
                                                                                                               ● Follow hospital
                                                                                                                 procedures for
        during      the     procedure.       "IBP1/IBP2                              asystole.                   clotted catheters.
                                                                                   ● Transducer turned
        CALIBRATION OK" indicates that the                                           off to the patient.
        calibration     procedure     is      completed                            ● A catheter tip lodged
                                                                                     against a vessel
        successfully. The last calibration time will be                              wall.
                                                                                   ● A clot on the
        saved and displayed in its corresponding                                     catheter tip.
        place.                                                     IBP1/IBP2
                                                                   SEARCH
                                                                                   IBP signal can’t be
                                                                                   processed by the
                                                                                                               ● Check all IBP
                                                                                                                 measurement
                                                                                   software because the          setup is suitable
        The following messages may prompt up in                                    signal is weak or less        or not.
                                                                                   pulsatile.                  ● Check patient
        CALIB WINDOW:                                                                                            and treat if
                                                                                                                 necessary.
        ■ "IBP1/IBP2 NO SENSOR, UNABLE TO
          CALIBRATE"
          Make sure that the transducer is connected
          or not, then start calibration procedure.
        ■ "IBP1/IBP2 OVERANGE, UNABLE TO
          CALIBRATE"
          Verify that adjusted pressure in menu and
          sphygmomanometer pressure are equal. If
          the problem persists, contact after sale
          service.
        ■ "IBP1/IBP2      UNSTABLE          PRESSURE,
          UNABLE TO CALIBRATE"
          Make sure that the transducer is not
          attached to the patient or perhaps the tubing
          system is hited accidentally .If the problem
          persists, contact after sales service.
        8. Remove the sphygmomanometer tubing
           and extra connector.
             Warning                                                                                 Warning
          Oxygen sensor for replacement should be                                                 Do not use the IRMA adapter if adapter or its
          stored in a cold environment (+2°C ~ +8°C)                                              package is damaged and return it to the
          and should be taken into operation before the                                           vendor.
          expired date printed on the package.
                                                                                                     Warning
          Replace the oxygen sensor every four months,                                            Use only the recommended IRMA airway
          when the system warns to change the sensor                                              adapters for monitoring .Other airway adapters
          with "REPLACE O2 SENSOR" message or                                                     may cause improper performance. (Refer to
          when the oxygen readings are questionable.                                              chapter 20 for detail)
             Warning                                                                                 Warning
          Use only the recommended oxygen sensor for                                              Do not use the adult/pediatric airway adapter
          O2 monitoring .Other oxygen sensors may                                                 with infants as the adapter adds 6ml dead
          cause improper performance. (Refer to chapter                                           space to the patient circuit.
          20 for detail)
                                                                                                     Warning
             Warning                                                                              Do not use the infant airway adapter with
          Depleted oxygen sensors shall be disposed of                                            adults as this may cause excessive flow
          in accordance with local regulations for                                                resistance.
          biologically hazardous materials.
                                                                                                  The infant airway adapter has specially
              Warning                                                                             designed connectors for minimizing the dead
          Do not leave depleted oxygen sensors                                                    space and can be used even for very small
          mounted in the IRMA probe, even if the probe                                            patients. The infant adapter is available without
          is not in use.                                                                          an oxygen port only.
             Warning
          Do not try to open the oxygen sensor                                                    Preparatory steps for gas measurement
          assembly. The oxygen sensor is a disposable                                             (Figure 39-44):
          product and contains a caustic electrolyte and                                          1. Plug the IRMA connector into the bedside
          lead.                                                                                      monitor side panel.
             Warning
          Disposable airway adapters shall not be
          reused. Used disposable airway adapters shall
          be disposed of in accordance with local
          regulations for contaminated and biologically
          hazardous fluids.
                                                                Pre-use check:
                                                                Before connecting the IRMA airway adapter to
                                                                the breathing circuit, verify the O2 calibration
                                                                by checking that the O2 reading on the monitor
                                                                is correct (21%). See Room air calibration
                                                                section for instructions on how to perform room
                                                                air calibration.
                                                                Perform the tightness check of the patient
                                                                circuit with the IRMA sensor head snapped on
         Fig. 41 - Preparatory step 3
                                                                the IRMA airway adapter.
                                                                Verify that there has not been any
        5. Connect the IRMA airway adapter 15 mm                accumulation of gas between the IRMA sensor
           female connector to the patient’s endo-              head and the XTP windows by checking that
           tracheal tube.                                       the CO2 readings on the monitor are correct
                                                                before connecting a patient to the breathing
                                                                circuit.
                                                                Check that the connections have been made
                                                                correctly by verifying an actual CO2 waveform
                                                                on the monitor display.
                                                                NOTE:
                                                                There is no drift of measurement accuracy.
                                                                NOTE:
                                                                Variations in barometric pressure do not
                                                                have any effects due to internal barometric
         Fig. 42 - Preparatory step 4                           pressure compensation.
                                                                NOTE:
        NOTE:                                                   There are no adverse effects on stated
        Alternatively, connect an HME (Heat                     performance due to cycling pressure of up
        Moisture Exchanger) between the patient’s               to 10 kPa.
        endotracheal tube and the IRMA probe.                   Room air calibration of oxygen sensor:
        Placing an HME in front of the IRMA probe               Room air calibration of oxygen sensor will be
        protects the airway adapter from secretions             performed automatically at regular intervals
        and effects of water vapour and eliminates              whenever the IRMA sensor head is
        the need of changing the adapter. It allows             disconnected from the IRMA airway adapter.
        free positioning of the IRMA probe as well.             If IRMA sensor is kept in operation for a long
                                                                time period without being disconnected from
                                                                the airway adapter, or if the operating
                                                                temperature for oxygen sensor changes
                                                                significantly, the IRMA sensor will indicate that
                                                                a new room air calibration is required and the
                                                                message will appear on the screen.
                                                                Use the following procedure to perform a room
                                                                air calibration of the sensor:
         Fig. 43 - HME option
          personnel of manufacturer.)
                                                                        NOTE:
             Warning                                                    Do not use the IRMA airway adapter with
          The device can only be operated by personnel                  nebulized medications because this may
          who have passed professional training and are                 affect the light transmission of the airway
          familiar with this manual.                                    adapter windows.
             Warning                                                    NOTE:
          Don’t use the device in the environment which                 Do not apply tension to the sensor cable.
          contains flammable anesthetic gas.
                                                                        NOTE:
             Warning                                                    Do not operate the device at temperature
          Before any interpretations are made of                        outside operating range as a below:
          parameters readings and waveforms one,                         IRMA ICU/OR/OR+: 10~35°C
          assure that the multi-gas probe is functioning                 IRMA AX/AX+:         10~40°C
          correctly. Partial obstruction of airway with                  IRMA CO2:            0~40°C
          water can result in distorted waveforms. A leak
          in the airway may result in low parameters                       Warning
          measurements. Check the monitor to see if it is               Verify sensor detection before starting GAS
          functioning properly.                                         monitoring. Unplug the sensor from IRMA
                                                                        connector to verify that the error message "NO
             Warning                                                    SENSOR "is displayed.
          Measurements can be affected by mobile and
          RF communications equipment. It should be
          assured that the IRMA sensor is used in the
          electromagnetic environment specified.
             Warning
          Do not place the IRMA airway adapter
          between the ET tube and an elbow, as this
          may allow patient secretions to block the
          adapter windows.
        NOTE:                                                           Warning
        FiAA and EtAA have different alarm ranges                    For accurate measurements, IRMA sensor
        for every anesthesia agent as a follow:                      should be set zero to room air.
          13 ST Monitoring                                            NOTE:
                                                                      If there are not at least 5 normal complexes
          13.1 General                                                in the last 50 beats of ECG signal, the ST
                                                                      value will not be displayed.
          ST segment deviation is defined as the
          displacement above or below the isoelectric                 ST monitoring function is “OFF” as a default.
          level. The measurement of deviation compares                You can switch it “ON”, when this monitoring is
          the isoelectric point to the ST measurement                 necessary.
          point.
                                                                      When ST monitoring is enabled, current ST
          The isoelectric point defines the point of zero
                                                                      values are trended and can be reviewed on the
          voltage (no electrical activity) with a default
                                                                      TREND window.
          position of 80ms from R wave as 0msec in the
          horizontal (time) axis. The ST point occurs in              NOTE:
          the ST segment between J-point and the T                    Measurement unit of ST segment is “mV”.
          wave, at a default position of 110 ms after R
          wave. The following figure illustrates a typical
          QRS complex.
        ■ ST LIMIT
          ST alarm is activated when the ST segment
          value exceeds adjusted ALARM HIGH value
          or falls below adjusted ALARM LOW value.
          (Range: -2 ~ +2 - step 0.1)
          Default for upper limit is +0.2 and for lower
          limit is -0.2.
        ■ EVENT DURATION
          Pick this item to determine the time that a
          potential ST alarm condition must persist on
          ECG waveform before the monitor classifies
          it as a valid alarm condition.                            Fig. 54 - ECG/ST ANALYSIS/DEFAULT POINT window
          Available options for EVENT DURATION are
          OFF, 15s, 30s, 45s and 60s. The default is                 As shown above, the DEFAULT POINT
          OFF and alarm will be activated immediately                WINDOW shows the dominant QRS
          if alarm condition happens.                                complex template. Two vertical lines indicate
                                                                     the positions of the ISO and ST points.
        ■ ST REALERN
          Pick to start a learning procedure. The                    ISO: It is the base point, used to indicate the
          “RELEARN” message is displayed in the                      baseline point of the ST analysis. The default
          ECG waveform area of the screen. It takes                  is 80ms.
          usually about 20 seconds                                   ST: It is the ST measurement point. The
                                                                     default is 110ms.
           During relearn procedure the following action             (Selectable between 5 to 400 ms by step of
           will be done:                                             5ms)
           - Blanks average stored dominant QRS                      The reference point is the position where the
             complex currently displayed on the                      peak of R-wave locates.
             DEFAULT POINT Window.
           - Learns and identifies the new dominant                NOTE:
             QRS complex template.                                 It is good clinical practice to check the
           - New complex is displayed on DEFAULT                   position of ISO and ST measuring points
             POINT Window.                                         before starting ST monitoring and finishing
                                                                   learning procedure.
        NOTE:
        You can do relearn procedure by selecting                  NOTE:
        <ARR RELEARN> in ECG/ARR ANALYSIS                          In practice, the accurate determination of
        window.                                                    ISO and ST measuring points requires
                                                                   careful clinical evaluation.
        NOTE:
        The monitor automatically begins to learn a                NOTE:
        reference template whenever you execute                    The ST measurement point should be
        any of the following tasks (If ST ANALYSIS                 adjusted if patient’s HR or ECG morphology
        is ON and there is no technical ECG alarm                  changes significantly.
        active, like CHECK LEAD):
        - Turning on the monitor                                   If the template is not established, a horizontal
        - Connecting ECG cable.                                    line will display. And if the ST ANALYSIS is
        - Changing an ECG lead configuration.                      “OFF”, the message “ST ANALYSIS KEY IS
                                                                   OFF” appears in this window.
        NOTE:                                                      You may select ISO or ST, and then switch the
        A yellow vertical marker with “LRN” label                  knob left or right to move the cursor line. When
        On ST in TREND window shows the time in                    the cursor is at the required position, you may
        which the learning procedure has been                      select the base point or the measurement
        done.                                                      point.
        ■ DEFAULT POINT                                            NOTE:
          Pick "DEFAULT POINT" in the ST                           Abnormal QRS complex is not considered
          ANALYSIS WINDOW to adjust the position                   in ST segment analysis.
          of both ISO and ST measurement points.
          When you change the ST and ISO                           NOTE:
          measuring point on the DEFAULT POINT                     If pace is on (for patient with pacemaker) or
          Window, the monitor recomputes the ST                    while learning procedure, there is no
          deviation value accordingly.                             waveform in DEFAULT POINT Window and
                                                                   you can see just ISO and ST line. In this
                                                                   condition, ST value will not be measured.
          NOTE:                                                                         NOTE:
          A red vertical marker with “CHG” label On                                     Arrhythmia monitoring is available for adult
          ST in TREND window shows the time in                                          and pediatric patient and it is not
          which the measuring point has been                                            recommended for neonates.
          changed.
                                                                                            Warning
                                                                                        The ARR monitor can only be operated by
          13.3 ST Alarm Message                                                         personnel who have passed professional
          Alarm limit is activated as a follow:                                         training and are familiar with this manual.
        The following table describes available beat                                  14.2 ARR ANALYSIS Window
        classifications:
                                                                                      Pick "ARR ANALYSIS“in the ECG WINDOW to
          Arrhythmia            Event and Beat Classification                         call up the following menu:
                                5 seconds pass without the detection of valid
          ECG ASYSTOLE
                                QRS complex.
                                Ventricular Fibrillation: The monitor identifies
                                a sinusoidal waveform with fibrillation
                                characteristics.        (Certain      ventricular
                                tachycardias have sinusoidal waveforms
          VFIB ARRHYTHMIA       closely resembling those of ventricular
                                fibrillation. Because of the similarity of these
                                waveforms, the monitor may classify such
                                types of ventricular tachycardia as
                                ventricular fibrillation.)
                                Ventricular Tachycardia: N or more PVC’s
                                are detected in a time interval T= (60*(N-
          VTAC ARRHYTHMIA
                                1))/R, where N is defined as the VTAC count
                                                                                       Fig. 56 - ECG/ARR ANALYSIS WINDOW
                                and R is defined as the VTAC rate.
                                Ventricular Run: Series of 3 to N-1
          RUN ARRHYTHMIA        consecutive PVCs with a beat to beat rate ≥
                                the VTAC rate.                                        ■ ARR ANALYSIS
                                Accelerated Idioventricular Rhythm: Series              Pick this item to enable or disable arrhythmia
          AIVR ARRHYTHMIA       of 3 or more PVCs with a beat to beat rate
                                less than the VTAC rate.                                monitoring. The default is “OFF”. When the
                                Ventricular Bigeminy: Sequence of beats
          BIGEMINY ARRHYTHMIA   with the pattern : normal ,PVC ,normal ,PVC,
                                                                                        Arrhythmia monitoring is disabled “PVCs
                                normal, PVC                                             OFF” is displayed in ECG parameters area.
                                Ventricular Trigeminy: Sequence of beats
          TRIGEMINYARRHYTHMIA   with the pattern : normal , normal ,PVC
                                ,normal , normal ,PVC                                 ■ ARR SETUP
          COUPLET ARRHYTHMIA
                                Ventricular Couplet: Sequence of beats with
                                the pattern : normal, PVC, PVC, normal,
                                                                                        Pick “ARR SETUP” in ARR ANALYSIS
                                PVC, PVC                                                Window to call up the following menu:
                                Sinus Tachycardia: N or more consecutive
                                normal beats, with a beat to beat rate ≥
                                TACHY rate setting. “N” is the event count
          TACHY ARRHYTHMIA
                                set in the ARR SETUP WINDOW.A PVC or
                                other abnormal beat breaks the analysis
                                sequence and restarts analysis.
                                Sinus Bradycardia: N or more consecutive
                                normal beats, with an average rate ≤ to
                                sinus bradycardia rate setting. N” is the
          BRADY ARRHYTHMIA      event count set in the ARR SETUP
                                WINDOW. A PVC or other abnormal beat
                                breaks the analysis sequence and restarts
                                analysis.
          PAUS ARRHYTHMIA       Actual R-R interval more than 2.1 times of
                                the average R-R interval.
          FREQUENT PVCs         More than N (event count set in the ARR
                                SETUP WINDOW) PVC per minute.
        When ARR analysis is enabled, current PVC                                       The ARR SETUP table allows you to
        values are trended every 20 second and can                                      configure arrhythmia monitoring accordingly
        be reviewed on the TREND window.                                                to your patient’s needs. All detectable
                                                                                        arrhythmia events listed in the first column of
            the table .Using the remaining columns, you               TACHY: Selectable between 5 and 12 by
            can modify the attributes of each event.                  step of 1.
            Fields that are not applicable for certain                BRADY: Selectable between 5 and 12 by
            event category are shown with dash symbol,                step of 1.
            while those that cannot be modified are                   FREQUENT PVCs: Selectable between 1
            ghosted.                                                  and 15 by step of 1.
            Modifying arrhythmia settings:                          ● ARCHIVE
            1. Scroll the cursor frame to parameters                  You can determine whether the selected
               whose arrhythmia functions you wish to                 event is stored, recorded automatically or
               configure and click.                                   both. You can view stored events on ARR
            2. Scroll to the function you wish to modify.             EVENT RECALL Window.
               (The first column, “ALARM LEVEL “, is                  STR: Stores selected arrhythmia event.
               highlighted when you first click on a                  REC: Automatically generates a recording of
               parameter.)                                            selected event.
            3. Click to access settings of the selected               STR/REC: Event stored and recorded.(even
               arrhythmia function.                                   when event alarm is turned off)
            4. Dial through settings and click to confirm             OFF: No action if arrhythmia event activates.
               your selection.
            5. Repeat step 1-4 to configure additional              ● ALL ALARM LEVEL
               arrhythmia functions or parameters.                    Press to set the level of all arrhythmia alarms
                                                                      to the same value.
          ● ALARM LEVEL
            Available options are 1, 2 and OFF to set the           ● ALL ARCHIVE
            grade of alarm for every arrhythmia event.                Press to set all arrhythmia                   ARCHIVE
            (For more detail about alarm levels refer to              condition to the same state.
            chapter 3.)
            Pick "OFF" to disable the alarm functions of            ■ ARR EVENT RECALL
            selected arrhythmia.                                      Pick " ARR EVENT RECALL” in ARR
            ALARM LEVEL for “ASYSTOLE” cannot be                      ANALYSIS WINDOW to call up the following
            modified and always is in level 1.                        menu:
          ● RATE
            With count, you can determine the point at
            which an event call is triggered.
            You can’t modify the rate for “ASYSTOLE”
            ,”VFIB”,      ”COUPLET”,          ”BIGEMINY”
            ,”TRIGEMINY”, “PAUS” and “FREQUENT
            PVCs”.
            “RUN” and “AIVR” derive their settings from
            “VTAC” and cannot be modified. They are
            included to quantify their derivation, based
            on current “VTAC” values.
            VTAC: Selectable between 100 and 200 by
            step of 10.
            RUN: Same as VTAC rate
                                                                     Fig. 58 - ECG/ARR ANALYSIS /ARR EVENT RECALL
            AIVR: ≤ VTAC rate-1
            TACHY: Selectable between 100 and 200 by                You can review any stored arrhythmia event
            step of 10.                                             (maximum 80 events) in this menu.
            BRADY: Selectable between 30 and 105 by
            step of 5.                                              ■ To review different event pages:
                                                                      Maximum of 8 arrhythmia events can be
          ● COUNT                                                     displayed in the window simultaneously.
            With rate, you can determine the point at                 When there is more than 8 events, different
            which an event call is triggered.                         pages are available. Pick the most left item
            You can’t modify the count for “ASYSTOLE”,                to review different pages.
            ”VFIB”,       ”COUPLET”,          ”BIGEMINY”,
            ”TRIGEMINY” and “PAUS”.                                 ■ To select an arrhythmia event:
            VTAC: Selectable between 5 and 12 by step                 Pick the second left item to select an
            of 1.                                                     arrhythmia event displayed in the window.
            RUN: Selectable between 3 and VTACcount
            -1 by step of 1.
            AIVR: Count≥3
                                                                              NOTE:
                                                                              The monitor automatically begins to learn a
                                                                              reference template whenever you execute
                                                                              any of the following tasks (If ARR
                                                                              ANALYSIS is ON and there is no technical
                                                                              ECG alarm active, like CHECK LEAD):
                                                                                - Turning on the monitor
                                                                                - Connecting ECG cable.
                                                                                - Changing an ECG lead configuration.
                                                                              NOTE:
         Fig. 59 - ECG/ARR ANALYSIS /ARR EVENT RECALL/WAVE window
                                                                              It is recommended to perform relearn
           In this window, waveform and time of                               procedure under the following conditions:
           selected arrhythmia event are displayed as                           - A lead is reconnected or electrodes
           well as the parameter values at the event                               are repositioned.
           time.                                                                - Eight hours have passed since last
                                                                                   reference complex learned.
        ● UP-DOWN                                                               - Other significant changes appear on
          This option allows you to page up and down                               the morphology of the patient’s ECG.
          to review the waveform and the parameters
          of other arrhythmia events.
        ■ ARR RELEARN
          Pick to start a learning procedure. The
          “RELEARN” message is displayed in the
          ECG waveform area of the screen.
        NOTE:
        You can do relearn procedure by selecting
        <ST RELEARN> in ECG/ST ANALYSIS
        window.
        NOTE:
        In most situations the learning phase takes
        about 20 second.
        17 Care And Cleaning                                      3. Don't let the cleaning agent enter into
                                                                     the chassis of the system.
        Before using the monitor, do the following:               4. Don't leave the cleaning agents on any
        ■ Check if there is any mechanical damage on                 part of the equipment.
          the system and accessories.
                                                                  The monitor and sensor surface can be
        ■ Check if all the power cable and accessories
                                                                  cleaned with hospital-grade ethanol and dried
          are firmly connected.
                                                                  in air or with a clean cloth.
        ■ Check if all the functions of keyboard and
          modules to make sure that the monitor is in
          proper condition.                                       17.2 Sterilization
        If you find any damage on the monitor, stop               To avoid extended damage to the equipment,
        using the monitor on patient, and contact the             sterilization is only recommended when
        biomedical engineer of the hospital or local              stipulated as necessary in the Hospital
        after sale service.                                       Maintenance Schedule.
        The overall check of the monitor, including the           Recommended sterilization material: Activated
        safety check, should be performed only by                 dialdehyde (Cidex).
        qualified personnel.
        All the checks that need to open the monitor                 Caution
        and the safety check and maintenance should               ■ Do not let liquid enter the monitor.
        be performed by after sales service.                      ■ No part of the monitor can be subjected
                                                                    to immersion in liquid.
        Note:                                                     ■ Do not pour liquid onto the monitor
        It is recommended to calibrate the system                   during sterilization.
        by manufacturer every 2 years. The IBP and                ■ Use a moistened cloth to wipe up any
        capnography modules should be calibrated                    agent remaining on the monitor.
        every 6 month.
           Warning                                                17.3 Disinfection
        If users do not follow a satisfactory
                                                                  Examples of disinfectants that can be used for
        maintenance schedule, the monitor may
                                                                  the case of monitor are listed below:
        become invalid, and human health may be
                                                                  ■ Hydrogen Peroxide 3%
        endangered.
                                                                  ■ Alcohol 70%
        Note:                                                     ■ Isopropanol
        To ensure maximum battery life, it is                     ■ Enpropanol
        recommended that, at least once a month,
                                                                  To avoid extended damage to the equipment,
        the monitor be run on battery until it turns
                                                                  disinfection is only recommended when
        itself off and then recharged (for details
                                                                  stipulated as necessary in the Hospital
        about battery care see 2.6).
                                                                  Maintenance Schedule.
        19 Technical Specification
        CLASSIFICATION
        Protection against electroshock                  Class I, Type CF for all modules (except Multi-gas module that is BF)
                                                         (based on IEC 60601-1)
        Mode of operation                                Continues operation equipment
        Harmful liquid proof degree                      Ordinary equipment (without liquid proof)
        Method of sterilization and disinfection         Refer to each module's chapters and chapter 17 for detail.
        Safety of anesthetic mixture                     Not suitable for use in the presence of a flammable anesthetic mixture
                                                         with air or with oxygen or nitrous oxide.
DISPLAY
ECG
ARRHYTHMIA ANALYSIS
ST ANALYSIS
NIBP
TEMPERATURE
RESPIRATION
          Method                                   Impedance
          Base resistance                          250 -1250 Ohm
          Dynamic range                            0.2 - 2 Ohm
          Breath rate range                        6 - 150 BrPM
          Accuracy                                 ±2% or 2 BrPM
IBP
          Channel                                  2
          Measurement Range                        SYS -50 ~ 300 mmHg
                                                   DIA     -50 ~ 300 mmHg
                                                   MAP -50 ~ 300 mmHg
          Pressure Filter                          8 Hz,16 Hz, 22Hz selectable
          Press Sensor Sensitivity                 5 µV / V / mmHg
          Press Sensor Impedance                   300 ~ 2500 Ohm
          Resolution                               1 mmHg
          Accuracy                                 2 % or 2 mmHg each one is greater
Multi-gas (Mainstream)
        Note 1: The accuracy specification is valid for all specified environment conditions, and includes effects from the following
        interfering gases: N2O, O2, HAL, ISO, ENF, SEV, DES, Ethanol, Isopropyl alcohol, Acetone, Methane, He. See Appendix IV for
        effects from water vapour partial pressure on gas reading.
        Note 2: The accuracy specification is not valid if more than one gas for IRMA OR and more than two gases for IRMA AX+ are in
        the gas mixture.
RECORDER
ALARM
TREND
        Sources                                               HR, PVCs, ST, SPO2, NIBP, RR, T1, T2, IBP1 (SYS, DIA, MAP), IBP2
                                                              (SYS, DIA, MAP), EtCO2, FiCO2, AWRR (sidestream, mainstream),
                                                              EtN20, FiN2O, EtO2, FiO2, EtAA, FiAA (ISO, DES, ENF, HAL, SEV)
        Trend time                                            1, 2, 4, 8, 16, 24 hours
        Resolution                                            20 sec
INPUT/OUTPUT
GENERAL
ENVIRONMENTAL
          Temperature              Operating:   5 to 40 °C
                                   Storage:     -20 to 60 °C
          For gas module           Operating:   10-35 °C
                                   Storage:     -20 to 50 °C
          Humidity                 20-90 % (non condensing)
          Altitude                 -200 to 3000 m
0044
        20 Trouble Shooting
        Repairing the internal parts of the monitor must be only done by trained and authorized personnel
        of after sale service; otherwise manufacturer will not take any responsibility for any possible
        hazard to the patient and the monitor.
        Troubleshooting guide is intended to help users to solve minor problems caused by incorrect use
        of the monitor or failure of accessories.
        When you face any problem, please be sure that you have followed all procedure mentioned in
        correct action column before you contact with after sale service.
21 Warranty
           1.   Within the warranty period we will eliminate free of charge any defects or damages on the device that are shown to be
                caused by a manufacturing or material error. The warranty does not include easily breakable parts, e.g. glass or
                consumable parts.
           2.   Warranty services can only claimed upon submission of a delivery note (bill of delivery or invoice); the type and method
                of damage remedy (repair or replacement) shall be at the discretion of HEYER MEDICAL AG. Warranty services do not
                result in an extension of the warranty period, nor do they entail a new warranty being granted. There is no independent
                warranty period for installed spare parts.
           3.   Excluded from the warranty are: Damages caused by improper use, operating errors, mechanical stress or non-
                observance of the operating instructions, as well as damages caused by force majeure or by extraordinary
                environmental conditions.
           4.   Warranty services may only be claimed if proof is submitted to confirm that all service and maintenance work has been
                carried out by authorized staff.
           5.   The warranty includes all faults that impair a faultless functioning of the device on the basis of technical defects of
                individual components. The warranty obligation can only be recognized by us if the device has been used properly and
                according to its intended use and no repair attempts have been undertaken by the client himself or by third parties. The
                warranty claim does not include faults caused by mechanical damages or if the device is being operated with
                accessories originating from third parties.
6. The warranty is also void if changes, alterations or repairs are made to the device by persons not authorized to do this.
7. The warranty claim only applies to customers of HEYER MEDICAL AG; it cannot be transferred to third parties.
           8.   The rejected device is to be shipped back to our plant postage free. In case of a request by our customer service
                department, the costs for shipping to the plant are to be initially generally borne by the customer. After successful repair,
                we will send the device back freight collect. If HEYER MEDICAL AG confirms the existence of a warranty claim, the
                customer will receive reimbursement for the costs of delivery and/or transport of the apparatus. Repair parts that do not
                fall under the warranty claim will be billed by us. The shipping of the device to us always counts as a complete
                assignment to eliminate all faults and/or replace missing parts, unless the customer expressly excludes partial services.
                Additional claims to transfer or reduce and replace damages of any kind in particular also of damages not incurred on
                the object of delivery itself are excluded.
        APPENDIX I
        List of monitor’s parameters (selection and defaults)
                                  3min,5min,10min,15min,30min,1hr
         AUTO/MANUAL                                                           MANUAL
                                  2hr,4hr,MANUAL
          APPENDIX II
          Monitor error messages
          ECG DEFECT        ECG module failure               Alarm level 2             Pressing ALARM SILENCE, alarm
                                                             The message is blinking   will be disabled and ignore this fault.
          ECG               Heart beat is not detected in    Alarm level 1             Pressing ALARM SILENCE, alarm is
          ASYSTOLE          last 10 seconds.                 The message is blinking   suspended for at least 120s.
          CHECK RL OR       RL or other leads are not        Alarm level 2             Pressing ALARM SILENCE, alarm
          ALL               properly connected when          The message is blinking   will be disabled and ignore this fault.
                            ECG lead is V, aVR, aVF or
                            aVR.
          CHECK LL OR       LL or other leads are not        Alarm level 2             Pressing ALARM SILENCE, alarm
          ALL               properly connected when          The message is blinking   will be disabled and ignore this fault.
                            ECG lead is I
          CHECK LA OR       LA or other leads are not        Alarm level 2             Pressing ALARM SILENCE, alarm
          ALL               properly connected when          The message is blinking   will be disabled and ignore this fault.
                            ECG lead is II
          CHECK RA OR       RA or other leads are not        Alarm level 2             Pressing ALARM SILENCE, alarm
          ALL               properly connected when          The message is blinking   will be disabled and ignore this fault.
                            ECG lead is III
                                                   RESP ERROR MESSAGES
          RESP CHECK        The RESP leads are not           Alarm level 3             Alarm is activated when RR ALARM
          LEADS             properly connected.              The message is blinking   is "ON". Pressing ALARM SILENCE,
                                                                                       alarm will be disabled and ignore
                                                                                       this fault.
          APNEA             Non-respiration condition        Alarm level 1             Pressing ALARM SILENCE, alarm is
                            overruns adjusted time           The message is blinking   suspended for at least 120s.
                                                   SPO2 ERROR MESSAGES
          SPO2 NO           SPO2 probe is disconnected       Alarm level 3             Pressing ALARM SILENCE, alarm
          PROBE             from the monitor.                The message is blinking   will be disabled and ignore this fault.
          SPO2 PROBE        SPO2 probe may be                Alarm level 2             Pressing ALARM SILENCE, alarm
          OFF               detached from the patient        The message is blinking   will be disabled and ignore this fault.
          SPO2 CHECK        SPO2 probe is not properly       Alarm level 2             Alarm is activated when SPO2
          PROBE             positioned to the patient        The message is blinking   ALARM is "ON". Pressing ALARM
                                                                                       SILENCE, alarm is suspended for at
                                                                                       least 120s.
          SPO2 HIGH         This may be caused by            Alarm level 2             Alarm is activated when SPO2
          AMBIENT           entering environmental light     The message is blinking   ALARM is "ON". Pressing ALARM
          LIGHT             into the probe                                             SILENCE, alarm is suspended for at
                                                                                       least 120s.
          SPO2 SEARCH       SPO2 is not calculable due to
                            some reasons such as long
                            time motions.
          SPO2 SIGNAL       The SPO2 signal amplitude is     Alarm level 2             Pressing ALARM SILENCE, alarm is
          WEAK              too weak or undetectable.        The message is blinking   suspended for at least 120s.
          SPO2 PROBE     The SPO2 probe is damaged        Alarm level 2              Pressing ALARM SILENCE, alarm
          DEFECT                                          The message is blinking.   will be disabled and ignore this fault.
                                                NIBP ERROR MESSAGES
          SELF-TEST      NIBP hard ware module            Alarm level is set in      Pressing ALARM SILENCE, alarm
          FAILED         failure                          NIBP WINDOW.               will be disabled and ignore this fault.
                                                          The message is blinking
          LOOSE CUFF     Cuff is completely               Alarm level is set in      Pressing ALARM SILENCE, alarm
                         unwrapped, no cuff attached      NIBP WINDOW.               will be disabled and ignore this fault.
                                                          The message is blinking
          MODE ERROR     Use adult cuff instead of        Alarm level is set in      Pressing ALARM SILENCE, alarm
                         neonate cuff or occlusion        NIBP WINDOW.               will be disabled and ignore this fault.
                         happened in air way              The message is blinking
          AIR LEAK       Air leak in cuff, tube or        Alarm level is set in      Pressing ALARM SILENCE, alarm
                         connector                        NIBP WINDOW.               will be disabled and ignore this fault.
                                                          The message is blinking
          AIR PRESSURE   Unstable pressure value (e.g.    Alarm level is set in      Pressing ALARM SILENCE, alarm
          ERROR          kinked hoses) because valve      NIBP WINDOW.               will be disabled and ignore this fault.
                         cannot open normally.            The message is blinking
           SIGNAL WEAK   Very weak patient signal due     Alarm level is set in      Pressing ALARM SILENCE, alarm
                         to a loosely wrapped cuff or     NIBP WINDOW.               will be disabled and ignore this fault.
                         extremely weak pulse from        The message is blinking
                         patient.
          RENG           Measuring pressure is more       Alarm level is set in      Pressing ALARM SILENCE, alarm
          EXCEEDED       than upper limit (255mmHg)       NIBP WINDOW.               will be disabled and ignore this fault
                         for adult or (135mmHg) for       The message is blinking
                         neonate
          EXCESSIVE      Arm movement, noisy signal       Alarm level is set in      Pressing ALARM SILENCE, alarm
          MOTION         or irregular pulse(e.g.          NIBP WINDOW.               will be disabled and ignore this fault.
                         arrhythmia)                      The message is blinking
          OVER           Measuring pressure               Alarm level is set in      Pressing ALARM SILENCE, alarm
          PRESSURE       exceeded safe software limit,    NIBP WINDOW.               will be disabled and ignore this fault.
          SENSED         290 mmHg for adult and           The message is blinking
                         145mmHg for neonate.
          SIGNAL         Large motion artifact that       Alarm level is set in      Pressing ALARM SILENCE, alarm
          SATURATE       saturates the amplifier's        NIBP WINDOW.               will be disabled and ignore this fault.
                         amplitude handling capability    The message is blinking
          PNEUMATIC      Leakage during leak test         Alarm level is set in      Pressing ALARM SILENCE, alarm
          LEAK                                            NIBP WINDOW.               will be disabled and ignore this fault.
                                                          The message is blinking
          TIME OUT       Measuring time exceeds 120       Alarm level is set in      Pressing ALARM SILENCE, alarm
                         seconds for adult or 90          NIBP WINDOW.               will be disabled and ignore this fault.
                         seconds for neonate              The message is blinking
          SYSTEM          Error occurs in pump, A/D       Alarm level is set in      Pressing ALARM SILENCE, alarm
          FAILURE        sampling, pressure               NIBP WINDOW.               will be disabled and ignore this fault.
                         transducer or software.          The message is blinking
          NIBP DEFECT    NIBP module failure              Alarm level is set in      Pressing ALARM SILENCE, alarm
                                                          NIBP WINDOW.               will be disabled and ignore this fault.
                                                          The message is blinking
          STOP           NIBP stop key has been
          PRESSED        pressed during
                         measurement.
          IBP1/IBP2      This condition occurs when        Alarm level 3             Pressing ALARM SILENCE, alarm
          STATIC         the maximum and minimum           The message is blinking   will be disabled and ignore this fault.
          PRESSURE       values of a pulsatile pressure
                         signal (Just for IBP, ART,
                         PAP, RVP and LVP labels)
                         differ by less than 3mmHg.In
                         this case, only Mean
                         pressure is displayed in this
                         state.
                         This message can be caused
                         by the following reason:
                         ● A physiological condition
                           e.g. asystole
                         ● Transducer turned off to
                           the patient.
                         ● A catheter tip lodged
                           against a vessel wall.
                         ● A clot on the catheter tip.
          IBP1/IBP2      IBP signal can’t be               The message is blinking
          SEARCHING      processed by the software
                         because the signal is weak
                         or less pulsatile.
          NO ADAPTOR     There is no adaptor connect       Alarm level 3.            Pressing alarm silence, alarm will
                         to the sensor.                    The message is blinking   be disabled and ignore this fault.
          CO2 INVALID.   CO2 outside specified             Alarm level 2.            Pressing alarm silence, alarm will
          PLEASE ZERO    accuracy range.                   The message is blinking   be disabled and ignore this fault.
          O2 INVALID.    O2 outside specified              Alarm level 2.            Pressing alarm silence, alarm will
          PLEASE ZERO    accuracy range.                   The message is blinking   be disabled and ignore this fault.
          N2O             N2O outside specified             Alarm level 2.             Pressing alarm silence, alarm will
          INVALID.PLEAS   accuracy range.                   The message is blinking.   be disabled and ignore this fault.
          E ZERO
          AGENT           Agent outside specified           Alarm level 2.             Pressing alarm silence, alarm will
          INVALID.        accuracy range.                   The message is blinking.   be disabled and ignore this fault.
          PLEASE ZERO
          ACCURACY        Two or more agent are out         Alarm level 2.             Pressing alarm silence, alarm will
          INVALID.        of range except O2                The message is blinking.   be disabled and ignore this fault.
          PLEASE ZERO
          O2 PORT         Clogged or plugged                Alarm level 2.             Pressing Alarm silence, alarm is
          FAILURE                                           The message is blinking.   suspended for at least 120S
          REPLACE O2      Replace O2 sensor every 4         Alarm level 2.             Pressing alarm silence, alarm will
          SENSOR          month.                            The message is blinking.   be disabled and ignore this fault.
          INVALID         Ambient pressure outside          Alarm level 2.             Pressing alarm silence, alarm will
          AMBIENT         operating range.                  The message is blinking.   be disabled and ignore this fault.
          PRESSURE
          INVALID         Internal temperature outside      Alarm level 2.             Pressing alarm silence, alarm will
          AMBIENT         operation range.                  The message is blinking.   be disabled and ignore this fault.
          TEMPERATURE
          AA1,AA2         Anesthetic mixture detected       Alarm level 2.             Pressing Alarm silence, alarm is
          AGENT           by module                         The message is blinking.   suspended for at least 120s.
          MIXTURE
          APNEA           No breath detect                  Alarm level 1.             Pressing Alarm silence, alarm is
                                                            The message is blinking.   suspended for at least 120s.
          ROOM AIR        If the sensor operate for a       Alarm level 2.             Pressing alarm silence, alarm will
          CALIB           long time period without          The message is blinking.   be disabled and ignore this fault.
          REQUIRED        being disconnected from the
                          adapter or the operating
                          temperature for oxygen
                          sensor changes significantly
          NO SENSOR       Sensor is disconnected from       Alarm level 3.             Pressing alarm silence, alarm will
                          system                            The message is blinking.   be disabled and ignore this fault.
          SENSOR          Manual setting and if no
          STANDBY         breath is detected for 30 min
          MODE            and EtCO2 is less than 4
                          mmHg for more than 30 min
          CSM SQI LOW    If the impedance of the white   Alarm level 3.             Pressing alarm silence, alarm will
                         or black sensors exceeds        The message is blinking.   be disabled and ignore this fault.
                         1kΩ, the SQI will fall
                         gradually. Poor impedance
                         conditions may cause the
                         SQI to fall to 50%. Artefacts
                         can have many causes: high
                         frequency instrument, EMG,
                         etc. are typical causes. If
                         SQI falls because of
                         extensive use of high
                         frequency instrument, it will
                         rise as soon as the high
                         frequency instrument is
                         stopped
          CSM            If sensor impedance is >        Alarm level 3.             Pressing alarm silence, alarm will
          IMPEDANCE      5kΩ the CSI, BS and EMG         The message is blinking.   be disabled and ignore this fault.
          HIGH           will be blanked
          CSM LINK OFF   CSM module is off or it is on   Alarm level 3.             Pressing alarm silence, alarm will
                         but wireless communication      The message is blinking.   be disabled and ignore this fault.
                         is not established.
        APPENDIX III
        EMC
           Warning
        Use only the recommended bedside monitor accessory. Using the accessory other than in relevant
        chapter may cause to increase the EMISSION or decrease the IMMUNITY of system.
           Warning
        Measurements can be affected by mobile and RF communications equipment. It should be assured
        that the bedside monitor is used in the electromagnetic environment specified.
            Warning
        To prevent EMC effect on the monitor, the system should not be used adjacent to or stacked with
        other equipment and that if adjacent or stacked use is necessary, the equipment should be observed
        to verify normal operation in the configuration in which it will be used.
          Warning
        Do not use cellular phone in the vicinity of this equipment. High level of electromagnetic radiation
        emitted from such devices may result in strong interference with the monitor performance.
      RF emissions
                               Class B
      CISPR 11
                                                       The VizOR is suitable for use in all establishments,
      Harmonic emissions                               including domestic establishments and those directly
                               Class A                 connected to the public low-voltage power supply
      IEC 61000-3-2
                                                       network that supplies buildings used for domestic
      Voltage fluctuations/                            purposes.
      flicker emissions        Complies
      IEC 61000-3-3
                                <5% UT
                                (>95% dip in UT)
                                for 0.5 cycle
                                40% UT                                             Mains power quality should be that of a
          Voltage dips, short
                                (>60% dip in UT)                                   typical commercial or hospital
          interruptions and
                                for 5 cycles                                       environment. If the user of the VizOR
          voltage variations
                                                                                   requires continued operation, it is
          on power supply       70% UT                                             recommended that the VizOR be
          input lines           (30% dip in UT)                                    powered from an uninterruptible power
          IEC 61000-4-11        for 25 cycles                                      supply or a battery.
                                <5% UT
                                (>95% dip in UT)
                                for 5 sec
d = 1.17 P
    NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
    NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
    absorption and reflection from structures, objects and people.
    a
        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 the VizOR is used exceeds the applicable RF compliance level above, the VizOR should be
      observed to verify normal operation. If abnormal performance is observed, additional measures may necessary, such as reorienting
      or relocating the VizOR.
    b
      Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
Notes:
Notes: