Mallinckrodt NPB-190 Betreibershandbuch

Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.To contact Mallinckrodt’s representative: In the United St

Safety Information2combinations of equipment must be in compliance with IECStandard 601-1-1 systems requirements. Anyone whoconnects additional equip

Data Port Protocol92Data SourceN-395 VERSION 2.0.0.0 CRC: XXXX SpO2 Limit: 70-100% PR Limit: 60-160BPMTIME %SpO2 BPM PA StatusData in the highlighted

Data Port Protocol93Patient Data and Operating StatusTimeTIME %SpO2 BPM PA Status12-NOV-99 14:00:05 100 120 50The Time column represents the N-395 rea

Data Port Protocol94Table 11: Status CodesCode MeaningAOAlarm OffASAlarm SilenceLBLow BatteryLMLoss of Pulse w/ MotionLPLoss of PulseMOPatient MOtion

Data Port Protocol95N-395 VERSION 2.0.0.0 TREND SpO2 Limit: 70-100% PR Limit: 60-160BPMTIME %SpO2 BPM PA Status12-NOV-99 14:00:05 100 120 15012-NOV-99

Data Port Protocol96alarm determine the voltage between these pins. The nurse callpolarity is set by using the procedures in the Start-up and Usesect

Data Port Protocol97ANALOG OUTPUTSThe N-395 data port also provides analog voltage outputsbetween pins 6, 13, 14, and ground (pins 5 or 10), which can

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99INDEX440-Second Trend Table · 50AAccessories · 12AdjustableSettings · 38Agilent (HP) Communications · 54Alarm LimitsChanging · 43Viewing Current · 4

Index100FFront Panel · 5GGCX Mounting Plate · 13GCX Poly-mount · 14, 15GCX Roll Stand Poly-mount · 16GCX Utility Basket · 17GRAPH MODE · 52HHistogram

Index101PPacking List · 11Patient CosiderationsImpact of Readings · 62Patient Movement · 26Performance Considerations · 25, 62Performance Verification

3INTRODUCTIONIntended UseGeneral Operating Principles and ConditionsThe latest version of this manual is available on the Internet at:http://www.malli

Index102Pulse Rate · 74SpO2 · 73Start Up and Use · 27Status Codes · 94SymbolsDate of Manufaqcture · 6Equipotential (Ground) Terminal · 6Fuse Replaceme

Introduction4Bone, tissue, pigmentation, and venous vessels normally absorb aconstant amount of light over time. The arteriolar bed normallypulsates

5CONTROLS, INDICATORS, AND SYMBOLSDisplays, Controls, Indicators, and ConnectorsN-395 SymbolsDescription of ControlsDescription of Displays and Visual

Controls, Indicators, and Symbols61. Equipotential (ground) Terminal 3. Fuse Receptacle2. Data Port Connector 4. Supply Voltage SelectorSwitchFigure

Controls, Indicators, and Symbols7DESCRIPTION OF CONTROLSFunction ButtonsThe Power On/Off Button. Used to turn the N-395monitor on or off.The ALARM S

Controls, Indicators, and Symbols8DESCRIPTION OF DISPLAYS AND VISUAL INDICATORSThe %SpO2 Display. Shows the saturation ofhemoglobin oxygen. The disp

Controls, Indicators, and Symbols9The Alarm Silence Indicator. Lights continuouslywhen an audible alarm has been silenced. It flasheswhen the alarm

Controls, Indicators, and Symbols10Low Priority Alarm A low-pitched, slow-pulsing toneindicating a sensor disconnect,sensor off, low battery, or monit

11SETUPUnpacking and InspectionPerformance VerificationList of ComponentsMonitor SetupLanguage SelectionUNPACKING AND INSPECTIONNotify the carrier if

Mallinckrodt Inc.675 McDonnell BoulevardP.O. Box 5980St. Louis, MO 63134Telephone 314.654.2000Toll Free 1.800.635.5267MallinckrodtEurope BVHambakenwet

Setup12Optional AccessoriesSeveral mounting configurations, a utility basket, and a carryingcase are offered with the N-395. Contact Mallinckrodt’sTe

Setup13GCX Mounting PlateAn optional mounting plate is available from Mallinckrodt for theN-395. This mounting plate fits standard, commercially avai

Setup14GCX Poly-mount (vertical wall mount with 19-inch channel)An optional vertical wall mount with 19-inch channel is availablefrom Mallinckrodt for

Setup15GCX Poly-mount (horizontal wall mount with rail adapter)An optional horizontal wall mount with rail adapter is availablefrom Mallinckrodt for t

Setup16GCX Roll Stand Poly-mountAn optional GCX roll stand poly-mount is available fromMallinckrodt for the N-395.The GCX roll stand poly-mount attach

Setup17GCX Utility BasketAn optional GCX utility basket is available from Mallinckrodtfor the N-395.The GCX utility basket attaches to the GCX roll st

Setup18Soft-Sided Carrying CaseAn optional soft-sided carrying case is available fromMallinckrodt for the N-395. See Figure 8. The padded carryingca

Setup19WARNING: Disconnect the N-395 and Nellcor sensor fromthe patient during magnetic resonance imaging (MRI)scanning. Induced current could poten

Setup20The battery may discharge during prolonged storage or shipment.If the monitor has been in storage for more than 2 months, it isimportant to plu

Setup21WARNING: Do not use a sensor cable with theN-395 monitor (other than the SCP-10 or MC-10 sensorcable). Use of another sensor cable will have

iiiCONTENTSFiguresTablesContents ... iiiFigures ...

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23SENSORSSelecting a SensorBiocompatibility TestingPerformance ConsiderationsSELECTING A SENSORWARNING: Before use, carefully read the sensor directi

Sensors24Table 1: Nellcor SensorsSensor Model PatientSizeOxisensorâ II oxygen transducers (Sterile,single-use only)N-25/N-25LFI-20D-20D-25/D-25LR-15

Sensors25PERFORMANCE CONSIDERATIONSWARNING: Pulse oximetry readings and pulse signal can beaffected by certain ambient environmental conditions, sens

Sensors26Note: Failure to take this precaution in high ambient lightconditions may result in inaccurate measurements.If patient movement presents a pr

27START-UP AND USEBasic OperationAlarmsAdjustable SettingsMenuLimitsTrendSetupBattery OperationDisposal of Device ComponentsPerformance Considerations

Start-Up and Use28WARNING: Each time the monitor is used, check alarmlimits to ensure that they are appropriate for the patientbeing monitored.Import

Start-Up and Use293. During the POST, the entire display lights and then theNellcor brand with model number and software version aredisplayed for appr

Start-Up and Use30Figure 9: Monitoring Mode Display - Pleth ViewFigure 10: Monitoring Mode Display – Blip(Magnified) ViewAdult-Pediatric and Neonata

Start-Up and Use31Note: The default power-on operating mode can be changed tothe neonatal patient setting by qualified servicepersonnel using the conf

ContentsivAt Initial Power-Up(Sensor Attached to Monitor) ...32At Initial Power-Up(No Sensor Attached to Monitor)...32A

Start-Up and Use32Note: Verify that indicators, display information, and audiblesounds including alarms are operational, indicating thatthe monitor is

Start-Up and Use33After Taking MeasurementsIf a pulse was previously acquired and then lost, the N-395enters Pulse Search, and the Pulse Search indica

Start-Up and Use34ALARMSThe following paragraphs describe the three levels of audioalarms and discuss the management of the loss-of-pulse alarm.Descri

Start-Up and Use35SatSeconds Alarm ManagementWith traditional alarm management, upper and lower alarmlimits are set for monitoring oxygen saturation.

Start-Up and Use36%SpO2 SecondsSatSeconds2 x 2 = 44 x 3 = 126 x 6 = 36Total SatSeconds =52After approximately 10.9 seconds the SatSeconds alarm woulds

Start-Up and Use37During such fluctuation, the N-395 integrates the number of%SpO2 points, both positive and negative, until either theSatSeconds limi

Start-Up and Use38SatSeconds DisplayWhen the N-395 SatSeconds technology detects an SpO2 valueoutside the alarm limit, the SatSeconds indicator begins

Start-Up and Use39Alarm VolumeTo view the current volume of the audible alarm, press and holdthe ALARM SILENCE Button for more than 3 seconds. Thecur

Start-Up and Use40If the alarm condition is still present when the alarm silenceduration has elapsed, the alarm will sound.WARNING: Do not silence an

Start-Up and Use41MENUMenu StructureThe four softkeys on the front panel are used to view or adjustthe following N-395 settings or functions:• %SpO2

ContentsvDefault Settings ... 58Nurse Call Feature ...

Start-Up and Use42A description of each menu item is included in the followingparagraphs.LIMITSWARNING: Each time the monitor is used, check alarmlim

Start-Up and Use43Changing Alarm LimitsUse the SELECT softkey to select the parameter that is to bechanged. Use the ADJUST UP/DOWN Buttons to change

Start-Up and Use44Table 3: Trend Menu

Start-Up and Use45Table 4: Setup Menu

Start-Up and Use46Alarm Limits Changed IndicatorIf alarm limits are changed from the N-395’s power-on defaults,a decimal point appears after the displ

Start-Up and Use47Figure 13: SpO2 TrendPeriods of time when no measurements were acquired areindicated by blank spaces in the graph as shown in Figur

Start-Up and Use48Scrolling past the limits of the right or left edges of the screencauses the viewing area to shift, relocating the cursor to themidd

Start-Up and Use49SpO2 Trend DisplayThe SpO2 trend display provides information on the %SpO2trend. See Figure 15.Figure 15: SpO2 Trend DisplayPulse

Start-Up and Use50NEXTVIEW EXIT12HR HISTOGRAM%SPO2 BPM25JUL 04:02--25JUL 16:0296-10091-9586-9081-850-8068%7%0%0%25%201-250151-200101-15051-1000-50

Start-Up and Use51back in time as the DOWN ARROW button is pressed andforward in time as the UP ARROW button is pressed.Figure 19: 40-Second TrendsWh

ContentsviMeasured versus Calculated Saturation ...84Data Port Protocol ...

Start-Up and Use52GRAPH MODE: The graph mode disables all printouts exceptfor trend printouts. Pressing the PRINT softkey from the trendmenu will pr

Start-Up and Use53Note: The N-395 will time out in 5 minutes when the SET andEXIT softkeys are displayed. However, it will time outin 10 seconds afte

Start-Up and Use54Agilent (HP) CommunicationsThe N-395 sends SpO2, pulse rate, and alarm status data to theAgilent monitor.The Agilent monitor require

Start-Up and Use55Figure 20: SpaceLabs ConnectionCaution: The SpaceLabs monitor must be turned on beforethe N-395 monitor is turned on.The SpaceLabs

Start-Up and Use56WARNING: Do not silence the N-395 audible alarm ordecrease its volume if patient safety could be compromised.The SpaceLabs monitor

Start-Up and Use57Datex-Ohmeda CommunicationsThe Datex-Ohmeda monitor AS/3 must be configured forcommunications with the Nellcor N-200 monitor in orde

Start-Up and Use58Press the NEXT softkey to access the LANG softkey. Afterpressing the LANG softkey, use the ADJUST UP/DOWNButtons to select English,

Start-Up and Use59Table 6: Factory Default Settings (Adult)Monitoring Mode Adult%SpO2 Lower Alarm Limit: 85%%SpO2 Upper Alarm Limit: 100%Alarm Silenc

Start-Up and Use60Table 7: Factory Default Settings (Neonate)Monitoring Mode NeonateNote: There are different default settings for the neonate mode.

Start-Up and Use61BATTERY OPERATIONThe N-395 has an internal battery that may be used to power themonitor during transport or when AC power is not ava

ContentsviiFIGURESFigure 1: N-395 Front Panel Display (Pleth View) ... 5Figure 2: N-395 Rear Panel ...

Start-Up and Use62Note: If the AC voltage selector switch on the rear panel doesnot match the AC voltage source, the monitor may runon battery power,

Start-Up and Use63Inaccurate measurements can be caused by:• prolonged patient movement• venous pulsations• intravascular dyes, such as indocyanine

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65TROUBLESHOOTING AND MAINTENANCETroubleshootingEMI (Electromagnetic Interference)Obtaining Technical AssistanceReturning the N-395MaintenanceTROUBLES

Troubleshooting and Maintenance66Table 8: Error Codes and MessagesErrorCodeErrorMessageAction4LOWBATTERYThe battery is discharged to a critically low

Troubleshooting and Maintenance67SENSOR OFF - The sensor has become disconnected from thepatient. Press the ALARM SILENCE Button to silence thealarm.

Troubleshooting and Maintenance68• If operating on battery power, the battery may bemissing or discharged. If the battery is discharged,notify servi

Troubleshooting and Maintenance69• The sensor may be too tight, there may be excessiveambient light, or the sensor may be on an extremitywith a blood

Troubleshooting and Maintenance70EMI (ELECTROMAGNETIC INTERFERENCE)Caution: This device has been tested and found to complywith the limits for medica

Troubleshooting and Maintenance71OBTAINING TECHNICAL ASSISTANCEThe latest version of this manual is available on the Internet at:http://www.mallinckro

ContentsviiiTABLESTable 1: Nellcor Sensors ...24Table 2: Limits Menu ...

Troubleshooting and Maintenance72The N-395 requires no routine service or calibration other thanchanging the battery at least every 24 months.If servi

73SPECIFICATIONSPerformanceElectricalEnvironmental ConditionsPhysical CharacteristicsCompliancePERFORMANCEMeasurement RangeSpO2 1 - 100%Pulse Rate 20

Specifications74Pulse Rate1Without Motion 20 - 250 ±3 digitsWith Motion Normal physiologic range (e.g., 55 – 125bpm) ±5 digitsELECTRICALInstrumentPowe

Specifications75ENVIRONMENTAL CONDITIONSTransport and Storage (in shipping container)Temperature -20 to 70°C (-4°F to +158°F)Altitude/BarometricPressu

Specifications76COMPLIANCEEmissions Compliance EN55011, CISPR 11, Group 1,Class BEquipmentClassificationIEC 60601-1 / CSA 601.1 / UL 2601-1Type of Pro

77QUICK GUIDE TO OPERATIONIntroductionSettings AdjustmentsINTRODUCTIONThis Quick Guide to Operation is intended for use byexperienced N-395 users. Fi

Quick Guide to Operation78Table 9: Settings AdjustmentsTo Adjust Action ButtonAlarm SilenceDurationPress and hold(for less than 3seconds)then,Pressor

Quick Guide to Operation79Table 9: Settings AdjustmentsTo Adjust Action ButtonBedside MonitorInterfacePressPressPressPressPressTo select AGILENT,SPAC

Quick Guide to Operation80Table 9: Settings AdjustmentsTo Adjust Action ButtonLanguage PressPressPressPressPressor , Pleth or Blip(magnified) ViewPr

Quick Guide to Operation81Table 9: Settings AdjustmentsTo Adjust Action ButtonSatSeconds PressPressPressPress to selectSatSecondsor

1SAFETY INFORMATIONGeneral Safety InformationGENERAL SAFETY INFORMATIONThis section contains important safety information related togeneral use of the

Quick Guide to Operation82Table 9: Settings AdjustmentsTo Adjust Action ButtonTime and DateSettingsPressPressPressPress(to select setting)PressPress

83PRINCIPLES OF OPERATIONOximetry OverviewOXIMETRY OVERVIEWPulse oximetry is based on two principles: that oxyhemoglobinand deoxyhemoglobin differ in

Principles of Operation84During monitoring, the instrument’s software reads this resistorvalue and selects coefficients that are appropriate for thewa

Principles of Operation85Figure 21: Oxyhemoglobin Dissociation Curve

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87DATA PORT PROTOCOLOverviewConnecting to the Data PortBaud RateSetting Data Port ProtocolReal-Time Display FormatTrend Data Printout (ASCII Mode)Tren

Data Port Protocol88(Information Technology Equipment) device must be certified toUL-1950 or IEC-60950.The cable used must have a braided shield provi

Data Port Protocol89The pin layouts (as viewed from the rear panel of the N-395) areillustrated in Figure 22. The conductive shell is connected toear

Data Port Protocol90Note: Selections for Agilent, SpaceLabs, GE Marquette, andDatex are included in N-395 software versions 1.7 andhigher.The protocol

Data Port Protocol91N-395 VERSION 2.0.0.0 CRC: XXXX SpO2 Limit: 70-100% PR Limit: 60-160BPMTIME %SpO2 BPM PA Status12-NOV-99 14:00:05 100 120 5012-NOV