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Classifications and Standards

The Camino ICP monitor has been designed for continuous operation. The Camino ICP Monitor meets the

electrical safety requirements for:

•

IEC 60601-1 4th edition and applicable particular and collateral standards

EMI / EMC

•

IEC 60601-1-2:2014

•

IEC 60601-2-49:2011

Electrical Safety

•

IEC 60601-1:2005/A1:2012

•

AAMI ES60601-1:2005+A1:2012

•

IEC 60601-2-49:2011

Содержание Camino ICP

Страница 1: ...1 Camino ICP Monitor Intracranial Pressure and Temperature Monitor User s Manual 025870 Rev 00 01 2019...

Страница 2: ...2...

Страница 3: ...d Johnson Tyvec is a registered trademark ofE I duPont Kimguard and One Stepare registered trademarks ofKimberly Clark Worldwide Inc Copyright Information 2018 Natus Medical Incorporated All rights re...

Страница 4: ...ro fortechnicalservice Domestic Natus Neurology Incorporated 3150 Pleasant View Road Middleton WI USA 53562 1 800 356 0007 madison helpdesk natus com International Natus Europe GmbH Phone 0049 0 89 83...

Страница 5: ...stem Overview 17 Indications for Use Intended Use 17 Contraindications 17 Intended User 17 Intended Patient Population 17 Description of the Camino ICP Monitor 18 Key Functions of Monitor 18 Reviewing...

Страница 6: ...r 35 Attaching to Equipment Pole if applicable 36 Powering the System On and Off 37 Turning On the System 37 Turning Off the System 38 Using the Battery for Power 38 Battery Power Indicator 39 Storing...

Страница 7: ...Data 62 Scaling Time Ranges for Trend Data 63 Scaling the ICP Ranges for Trend Data 63 Conditions that Reset Trend Data 63 Setting the High ICP Alarm Limit 64 About the High ICP Alarm Limit Calculati...

Страница 8: ...Alarms 81 Responding to ICP Catheter Failure Alarm 81 Silencing the Catheter Failure Alarm Temporarily 81 Responding to Temperature Sensor Failure Alarm 82 Silencing the Catheter Failure Alarm Tempora...

Страница 9: ...g Guidelines 94 Sterilizing the Camino Fiber Optic Catheter Cable 96 Limits on Sterilization 96 Sterilization Parameters 96 Sterilization cycle parameters for the fiber optic cable 97 Following Steril...

Страница 10: ...g 112 Using a Pressure Simulator preferred method 116 Testing Pressure Output 118 Testing Temperature Input 119 Temperature Transducer Connector Test Circuit Diagram 120 Testing Temperature Output 121...

Страница 11: ...X A Technical Specifications 133 List of Technical Specifications 133 Classifications and Standards 135 Manufacturer s Declaration Table 136 General Notes 136 APPENDIX B Natus Medical Incorporated War...

Страница 12: ...12 Blank page...

Страница 13: ...ofa physician Class II equipment Serial number WasteElectronics and Electrical Equipment Batchcode USB connection Manufacturer Safetyinformationfortransporting lithium ionbatteries Date ofmanufacture...

Страница 14: ...efinition Active alarm On Off power Audiopaused ACpower not being used available Inactivealarm Batterycharge indicator AlarmOff Nobatteryconnectedor faulty battery High ICPalarm limit Batterybeingchar...

Страница 15: ...Current DMM DigitalMultimeter EtO Ethylene oxide F Fahrenheit FLEX FlexCatheter FLEXEXT Flex Extension Cable hPA Hectopascal pressure unit ICP Intracranialpressure ICT Intracranial temperature IPA Iso...

Страница 16: ...16 Blank page...

Страница 17: ...ould perform the placement and handling ofthe catheters Designated qualified hospital staff e g neurosurgeon nurse intensivist trauma physician or physician s assistant should perform the operation of...

Страница 18: ...y functions tofacilitatetheprocess formonitoring andanalyzingpatient data Touch screeninterface forevaluatingpatient ICP ICTdata andsettingpatient parameters Physiologicalalarmthat activates ifthe pat...

Страница 19: ...nitor alwayshandle withcare If damageissuspected contact Natus Neuro Read the user smanual from the patient bedside monitor s manufacturer before connecting the Camino ICP Monitortoapatient bedside mo...

Страница 20: ...diately ifthelow batteryalarm is activated Whenusingthe battery Do notheat above 80 C Do notopen battery Do notdispose ofinfire Do notshortcircuitas batterymayignite explode leak or gethot causing per...

Страница 21: ...mino FlexCatheter hasbeen initialized i e autozeroed by the Camino ICP Monitor do not transfer this initialized cathetertoany other monitor Transferring aninitialized catheter toa different monitor ma...

Страница 22: ...Thefrontpanel contains Number Item Description 1 Handle Handle usedforcarryingthe monitor 2 Touch Screen Provides softwaretoolsforviewing dataand controlling parametersformonitoring the patient s ICPa...

Страница 23: ...n port forthe AC power cord 3 PMIO Port Connection portforPMIOcable This cable isusedto connect the Camino ICP Monitor to a patient bedside monitor 4 Pole Clamp Clamping systemforsecuring monitorto an...

Страница 24: ...erature Port Connectionportforthetemperatureconnectoron the FiberOptic Catheter Cable 2 Pressure Port Connection port for the ICPconnector on the Natus Camino Flex Extension Cable pressure only 3 Pres...

Страница 25: ...ompanel contains Number Item Description 1 Battery DoorCover Removablecover foraccessing replacing the 14 4Vlithium ion battery 2 Air Vent Gratedopening thatallows air being circulated by the internal...

Страница 26: ...26 About the Left Panel Theleftpanel doesnotcontain anyusableconnector ports or buttons...

Страница 27: ...pping boxand verify thefollowing itemsare included Warning OnlyuseNatusNeurosuppliedaccessoriesontheCaminoICPMonitor Thisappliesin particulartocatheters cathetercables battery ACpoweradapter andUSB to...

Страница 28: ...1 Camino Flex Extension Cable REF FLEXEXT Quantity 1 USB to RS232adaptercable REF 025440 Quantity 1 User manual REF 025870 Quantity 1 After unpacking the contents inspect the shipment foranysigns ofd...

Страница 29: ...ndle isfacing downward 3 Removethe 2 screws to take off the batterycover 4 Verifythe Natus Neurologo on the batteryisfacing up andinsert the battery A Align the battery sconnectors on the frontoftheba...

Страница 30: ...region specific adapterplug tothe backside ofthe AC power adapter Backside of AC power adapter US UK Europe Australia A Align the two slots on the adapter plug over the two prongs on the AC power adap...

Страница 31: ...31 C Gentlyslidethe adapterplug forward untilit snaps intoplace 2 Toremovethe adapterplug pressthe releasebutton on the AC power adapter and pull the plug awayfrom the adapter...

Страница 32: ...ndofthe ACpower adapter intoagrounded AC wall outlet 3 Turnon the monitor Onthe frontofthe monitor pressthe power button the Camino ICPMonitor will displaythe Natus Neuro logo before initiating the mo...

Страница 33: ...tingthem in the following step 3 Press Accept the Camino ICP Monitor will display the selectedtime date onthetouchscreen Step 6 Specify the Language 1 Onthe touch screen press the Settingstab fourth t...

Страница 34: ...Keepthe Camino ICPMonitoron ACpower withthemonitor turnedoff for5hours This will re chargethe batteryto full capacity 3 After 5hours turn on the monitor by pressingthe power button 4 Onthe touch scree...

Страница 35: ...urfaceor securely clamped toan equipment pole or bed support next tothe patient Thedistance between the patientandthe monitor is restricted by the lengthofthe Natus catheter cable Itisnotpermittedtoex...

Страница 36: ...pole 1 Clamp 2 Pole Note that the pole clamp supports equipment polesbetween 0 5 and1 2inches 12 7and 30 5mm in diameter Warning Topreventinjury tothepatient user or other persons or damagetothemonit...

Страница 37: ...n AC power outlet A On the backofthe monitor attach the connector endofthe ACpower adapter intotheportlabeled Input 18 V 1 AC power adapter 2 AC power adapter connector B Insert the plug endofthe ACpo...

Страница 38: ...and doesnotturnoff pressand hold the Power button forseveral seconds to perform aforced shutdown ofthesystem Using the Battery for Power The Camino ICPMonitor includes arechargeable 14 4Vlithium ionb...

Страница 39: ...ak orgethotcausingpersonalinjury Replacebatterywithsamepartnumberonly REF 026950 Useofanotherbatterymaypresentariskoffireorexplosion Warning Topreventinjury tothe patient user or other persons makesur...

Страница 40: ...nitor prior tostoringthemonitor Ensure the batteryis stored in acool dry and well ventilatedarea Notice If theCaminoICPMonitorisnotusedforalongdurationoftime thebatterywilllosecharge Alwaysmakesurethe...

Страница 41: ...ed catheters Camino Flex ICP A silicon strain gauge pressure transducer tipped 9 10 FR catheter For complete instructions on usingcatheters seethe directionsforuse supplied by Natus Neuro witheach res...

Страница 42: ...ient Inparticular alwaysmakesuretoadjustthenewFiberOptic Catheter sICPvaluetozerobeforeimplantationwhilethecatheterisintheair Neverattemptto changethezero adjustmentwhilethecatheterisinsidethepatient...

Страница 43: ...hemonitor before proceeding 2 When operatingin the sterilefield selectthe desired Camino Pressure Monitoring Kit model 110 4 series For instructions on usingthe kit see the directionsforusesupplied wi...

Страница 44: ...e reads 0mmHgon the monitor To verify presstheMaintabonthetouchscreen and view the ICPvalue Ifthe ICP value doesnotread 0mmHg A Pressthe Scale button onthe Main tab to select awaveform rangeof 10to 20...

Страница 45: ...OpticCatheterCable beingusedforpatientmeasurement ReplacingtheFiberOpticCatheterCablewithadifferentcableaftertheICPcatheter hasalreadybeenzeroedmayresultininaccuratepatientmeasurements Warning Oncethe...

Страница 46: ...wCaminoFlexCatheterintothepatient Inparticular alwaysleavetheFlexCatheterintheairuntilthemonitor completestheautozero i e initialization processsuccessfully To connect 1 Onthe monitor s rightside atta...

Страница 47: ...nector Male endof FlexCatheter Female end of FlexExtension Cable 4 When attached correctly the Camino ICP Monitor will display Catheter is initializing in the statusbar 5 Verifythe following message a...

Страница 48: ...er alarms caused by the sudden changesin pressure seethefollowing section fordetails 8 After implanting the catheterintothe patient reconnect the FlexCatheter to the FlexExtension Cable Warning Onceth...

Страница 49: ...smayoccur while the catheter istraveling Dependingon the levelofpressure change theICP measurements may temporarilyexceedthe ICPaccuracy range forthemonitor between 10 mmHg and125mmHg andtrigger oneof...

Страница 50: ...dside monitor Monitor Adapter Cable ICPXX and ICTXX Adapter cables that fit between the PMIO cable and the vendor specific patient bedside monitor Todetermine which monitoradaptercablesarerequired for...

Страница 51: ...the CaminoICP Monitor becomesdisconnected from apatient bedside monitor e g due topatient transport toCT or OR and then needs tobe re connected If during use the reported ICP valuesbetween the Camino...

Страница 52: ...nd adaptercable to thetemperature pressure modules on the patient bedside monitor Notice TheCamino ICPMonitordoesnotmeasureCerebral PerfusionPressure CPP ranges Asaresult the CPP connector on the PMIO...

Страница 53: ...CP value Ifyou arenot checking additional values proceed tothefinal step Completethe SynchronizationProcess in Chapter 3 A On the Camino ICPMonitor s touchscreen pressthe Check Additional Valuesbutton...

Страница 54: ...CP Monitor s measurements over the patient bedside monitor s measurements If drift occurs between the two monitors use the Camino ICP Monitor s ICP values for the patient s measurements and repeat the...

Страница 55: ...ensing Also ensure the storage location is safefrom any liquids that may drip inside the monitor and damageits internal components Using the Cable Strap to Wrap the AC Power Adapter The Camino ICPMoni...

Страница 56: ...56 Blank page...

Страница 57: ...end Provides tools for monitoring for up to a 5 day history of the patient s intracranial pressure values For details see Chapter 4 Alarm Provides tools for specifying a high ICP alarm limit the monit...

Страница 58: ...the statusbaron the bottomofthe touchscreen willdisplay messagesto indicate the current statesofalarms catheters andAC batterypower Status bar Verifying Status of Battery and AC Power The Camino ICP M...

Страница 59: ...utes or less the monitor will display an error message on the status bar Ifthe levelofbattery chargefalls to 5minutes or less themonitor will activate a technical alarm Formore information see Chapter...

Страница 60: ...Hg versus time as an animated waveform solid or line To specify the waveform type press the Settings tab For instructions see Chapter 4 2 Displays the Mean ICP in mmHg as numerical values 3 Displays t...

Страница 61: ...e ICP Waveform Ranges IftheICPwaveformson the Mainpanelrequire resizing forclarity pressthe Scalebutton tospecify differentwaveform ranges The ranges include Ranges mmHg Increments mmHg 0to 30 5 0to 5...

Страница 62: ...d to the USB port on the rear of the monitor 2 Data Streaming Enabled Indicates that the feature for streaming patient trend data digitally to another media type has been activated This feature requir...

Страница 63: ...rend Data Ifthe ICPwaveformsonthe Trendpanelrequire resizing foroptimal viewing pressthe ICP Scale button tospecify differentwaveform ranges The ranges include Ranges mmHg Increments mmHg 0to 30 5 0to...

Страница 64: ...n alarm if the patient s displayed MeanICPexceeds the specified high ICPalarm limit for more than 5 seconds Bydefault this option isselectedand set to 20 mmHg 2 Alarm Off Deactivatesthe physiological...

Страница 65: ...asnumerical values 6 Temperature Displays tissue temperaturein degrees Celsius C About the High ICP Alarm Limit Calculation The Camino ICPMonitor bases the high alarm limitonthepatient s Mean ICPvalue...

Страница 66: ...Inthe High ICP Alarm Limitfield usethe arrows to specify the high ICPalarm limit value forthe patient Note thatthe range limits arebetween 10to 125 mmHgin 1 mmHgincrements 4 Press Accept If the patie...

Страница 67: ...e alarmlimitspecified in step3appears intheMainandTrendscreens asthefollowing indicator labels Ahorizontal line in thegraph corresponding to the specifiedhigh ICPalarm limit Anumerical valuenext to th...

Страница 68: ...ctive alarm symbol on the status bar Thiswillsilence the alarm for either 3minutes or untilthe patient sMean ICP valuefalls within the specifiedlimit In this silencedstate the status bar willdisplay A...

Страница 69: ...waveform lineor fill that isdisplayedon the Main panel 2 Set Time and Date Specifiesthe time and date that isdisplayed on the monitor The purpose ofthe time date displayisfortheExtract Data feature 3...

Страница 70: ...laying the ICP waveform aseither aline or filled graph 1 Waveform settoFillmode 1 Onthe touch screen pressthe Settingstab 2 Press Set Waveform 3 Specifythe waveform typeby selecting either Line or Fil...

Страница 71: ...n pressthe Settingstab 2 Press the Set Time and Datebutton 3 On the displayed panel pressthe desired field hour minutes date month or year and usethe arrows to specifythe appropriate setting Note that...

Страница 72: ...ench Japanese Chinese Simplified Italian Russian Portuguese Brazilian German Danish Spanish Polish To change the language 1 Onthe touchscreen pressthe Settingstab 2 Onthe left side ofthe panel pressSe...

Страница 73: ...tton only appears on the System Information panel if a USB drive is connected to the Natus Camino ICP Monitor Note that when attaching a USB drive this button may take several seconds to appear Pressi...

Страница 74: ...74 Blank page...

Страница 75: ...These technical alarms include Irreversible System Failures ICP catheter failure Temperature sensor failure Low battery level 5 minutes or less Monitor overheating Cooling fan failure Mean ICP is out...

Страница 76: ...description ofthe error thatactivatedthe alarm crossed outyellow borders Audio Paused Indicates an active physiological or technical alarm that has been paused temporarily by pressing the active alarm...

Страница 77: ...ofthree pulses with apulse separation of180milliseconds and a burst separationof3 seconds Thevolume ofeachalarm pulse measures asound pressure of70 dB Amessage will appear on the status bar that iden...

Страница 78: ...ystem failure which results in the monitorbeing unusable Theremaining technicalalarms willonly become announced after the physiological alarmisresolved How the Monitor Prioritizes Between Two Technica...

Страница 79: ...ition seeChapter 5 Thefollowing tableliststhe priorities ofeachalarm condition Alarm Priority Type of Error Condition Type of Clinical Priority 1 Irreversible System Failures Medium 2 High ICP alarm M...

Страница 80: ...h the Mean ICPvalue in yellow on the Main Trend andAlarmscreens To silence the alarm temporarily pressthe flashing alarm symbol on the touch screen This willsilence the alarm foreither 3minutes or unt...

Страница 81: ...ncompatible firmware error For acomplete listoferror codes see Chapter 8 Pleasenote that each ofthese alarmconditions are irreversible Ifanyofthese alarmsoccur tendtothepatient s need note the specifi...

Страница 82: ...msymbol on the touchscreen This willsilencethe alarmfor 3minutes Ifthecatheter isnot disconnected within3minutes the alarm will reactivate Responding to Low Battery Alarm The Camino ICPMonitor include...

Страница 83: ...ACpower outlet immediately Thisalarm willstoponce themonitor is connected toAC power Warning ConnectthemonitortoanACpowersupplyimmediatelyifthelowbatteryalarmisactivated Silencing the Low Battery Ala...

Страница 84: ...ns Ifthetemperature inside the monitor doesnotfall below 80 C within3minutes the alarm will reactivate Responding to Cooling Fan Failure Alarm The Camino ICPMonitor contains aninternal fanthat circula...

Страница 85: ...rm containing aburst ofone single pulse every16seconds Display one ofthefollowing messages on the statusbar ICP is out of accuracy range or Temperature is out of accuracy range Display the Mean ICPor...

Страница 86: ...ossed out Displaysthefollowing messageon the status bar Battery Failure Ifthis batteryfailure alarmactivates do notrun the monitoron batterypower If necessary plug themonitor into an ACoutlet tomainta...

Страница 87: ...ingviathe USB to RS232adaptercable Both mediatypesare connectedtothe monitor viaa USB connectionthat is located on the rearpanel Notice The USBconnector port on the CaminoICPMonitor isonlyintendedforc...

Страница 88: ...his csv file records the date time and Mean ICP values in one minute intervals and displays the information as ASCII text The following text provides a sample csv trend data entry 2011 04 20 13 38 18...

Страница 89: ...raction is based on the monitor s date time settings that are specified on the Settings tab In countries where daylight savings are observed the time must be adjusted manually For instructions see Cha...

Страница 90: ...SB to RS232adapter cabledelivers the information as9600 baud 8 data bits 1 stop bit even parity configurations To connecttheUSB to RS232adapter cabletoa computer you needafemaleto female null modem RS...

Страница 91: ...on Batterydischargescompletely resulting in the monitoring being turnedoff andthen turned backon The current ICPcatheterisdisconnected from themonitorand thenre connected Thecurrent temperature cathet...

Страница 92: ...92 Blank page...

Страница 93: ...sk ofshock follow all safetynotices and never open the monitor case Themonitor isdesigned forsurface cleaning only do NOTimmerse Never spraycleaning agents or other fluids directly onto themonitor Use...

Страница 94: ...agents listed in this section forcleaning and disinfecting the Camino ICPMonitor system Using solvents or cleaning agents not listed in the cleaning guidelines may damage the plastic exterior of the C...

Страница 95: ...or equivalent solution thoroughly wipe all surfaces at least three 3 times and then inspect the surfaces for visible residues If residues remain use a new Super Sani Cloth or equivalent solution or li...

Страница 96: ...ion Parameters The Camino FiberOptic CatheterCable supportsEtOandSterrad sterilization methods Notice PriortoEtOsterilization the cableshould beindividuallypackagedin aself sealingsterilization pouchw...

Страница 97: ...monitoring process Before eachuse visually inspect the sterilized cablesforanypossible defects Do notusedefective cables Sterilizing the CaminoFlex Extension Cable The FlexExtension Cable REF FLEXEXT...

Страница 98: ...sterilization wraps sterilization pouches chemical indicators biological indicators andsterilization containers that havebeen cleared by the US FDA forthe selectedsterilization cycle specifications t...

Страница 99: ...mponents Unless stipulatedotherwise in the sales contract the end of life Camino ICPMonitor cables and AC power adapter must be returnedtoNatus Neuro fordisposalor disposed according tothe hospital re...

Страница 100: ...100 Blank page...

Страница 101: ...tem Message Cause Recommendation Battery failure Battery scontrol system hasfailed Plug Camino ICPMonitorintoAC power outlet After patient treatment turnoff Camino ICPMonitor and then turnbackon Repla...

Страница 102: ...us Neuro Data export failed Could not detect or write to a USB drive Problem withconnection or compatibility of USB drive No transferoftrend data via USBconnection ICP above alarm limit Patient s Mean...

Страница 103: ...onnected to CaminoICP Monitor Connect ICP catheter seeChapter 3 Temperature is out of accuracy range Temperature value hasfallen under rangethat the Camino ICP Monitor can measure accurately between 3...

Страница 104: ...stto ensure ACpower works Contact Natus Neuro to order new ACpower adaptercord Camino ICP Monitor doesnot operate on battery power Batterynotinstalled AttachACpower adapter toCamino ICP Monitor Ontouc...

Страница 105: ...onitor Make surethe cableisproperly connected to the Camino ICP Monitor Poorconnection between Fiber Optic Catheter Cable or Flex ExtensionCable and the catheter Replace the catheter seedirectionsforu...

Страница 106: ...ageis displayed Choice oflanguage isset incorrectly On touch screen pressSettingstab and selectSet Languageto specify language Discrepancy ofICP measurements between the Camino ICP Monitor andthe pati...

Страница 107: ...Camino ICPMonitor and patientbedside monitor Patient bedsidemonitor has malfunctioned Referto manufacturer s troubleshooting guide forthe patient bedsidemonitor Notransfer oftrend data via digital str...

Страница 108: ...The USBdrive is not formatted withthe FAT FAT16or FAT32 file system Insert a USBdrive withFAT FAT16or FAT32 formatted file system USBdrive has been removed beforecompletion ofdata transfer Re connect...

Страница 109: ...E2041 E2042 E2044 E2045 E2046 E2047 E2048 E2049 E2051 E2057 E2061 E2101 E2103 E2104 E2105 Sensor board failure Not resolvable contact Natus Neuro E0012 E1002 E1003 E1004 E1008 E1032 E1033 E1041 E1042...

Страница 110: ...110 Blank page...

Страница 111: ...no ICP Monitorisoperating safely and effectively Somechecksmay be helpful to diagnoseproblems thatmayoccur withthe system None ofthese checksrequire disassembling the monitor Notice Theoperationalchec...

Страница 112: ...testguidelines Guidelines Requirements Maintenance Interval Onceevery three months issuggested Equipment Natus Camino FiberOptic Catheter Cable New Natus Camino FiberOptic Catheter 110 4series ICP me...

Страница 113: ...e ofthe monitor attach the FiberOptic Catheter Cableand a functional FiberOptic Catheter to theICP CAMCABL port 3 Fillhalf ofthe I V bag withwater 4 Connect one endofthetubingto the I V bag and the ot...

Страница 114: ...fy thatair bubbles arenot present and replacethe end cap 8 Verifythat the waterlevelfrom the I V bag and the tip ofthe FiberOptic Catheterare atthe samelevel In this example the catheter s tipandthe w...

Страница 115: ...led withthe6 inch markofruler Note the following unitconversion 1 inch H20 1 8683 mmHg Onthe touchscreen verify the ICPvalue reads 7 2mmHg 11 RaiseI V bag foranother 6inches 12 Onthe touch screen veri...

Страница 116: ...d Equipment Natus Camino FiberOptic Catheter Cable New Natus Camino FiberOptic Catheter part 110 4BT ICP temperature measurements Pressuresimulator between 0and 125mmHg e g Delta Cal 650 950 Tubing an...

Страница 117: ...rOptic Catheter intothemanifold 5 Connect the other endofthe manifold to the pressuresimulator 6 Ifnecessary adjust the pressure simulator to 0mmHg 7 Verify thatthe ICPvalues on both the pressuresimul...

Страница 118: ...rnal patient bedside monitor 3 Using the DCbench power supply and the Digital Multimeter DMM do the following A Set DCpower supply to 10 0 1 volts andconnect and leadsto pins 1 and 4 ofthe sixpin cann...

Страница 119: ...he CaminoICP Monitor to an AC wall outlet 2 Onthe rightside ofthe monitor connecta Fiber Optic Catheter Cableto the ICP andTemperature connectors 3 Using afunctionalFiberOptic Catheter firmly connect...

Страница 120: ...ntiometerto produce areading onthe DMM of0 350 VDC On the touchscreen theTemperature value should read30 0 0 3 C 9 Adjust the 10K potentiometerto produce areading on the DMM of0 438 VDC T On the touch...

Страница 121: ...t 025420 Notice Beforeperformingthistest verifythattheCaminoICPMonitoristurnedoffandnotconnectedtoanycables 1 Plugthe CaminoICP Monitor to an AC wall outlet 2 Onthe rightside ofthe monitor connecta Fi...

Страница 122: ...0 verify that the measured resistance isbetween the low and high limits forthe displayed temperaturevalue 8 Fill awater bath or beakerwithwarm water at approximately38 Cand do the following A Place th...

Страница 123: ...84 1716 37 5 1310 1344 31 6 1676 1708 37 6 1305 1334 31 7 1676 1700 37 7 1300 1329 31 8 1668 1700 37 8 1295 1324 31 9 1660 1692 37 9 1290 1319 32 1652 1684 38 1285 1314 32 1 1635 1684 38 1 1280 1309 3...

Страница 124: ...s 1 Plugthe CaminoICP Monitor to an AC wall outlet 2 Onthe rightside ofthe monitor connecta Fiber Optic Catheter Cableto the ICP andTemperature connectors 3 Using afunctionalFiberOptic Catheter firmly...

Страница 125: ...hecurrent ICPvalue in yellow on the Main Trend andAlarmscreens 8 Silencethe alarm temporarily Onthe touchscreen pressthe flashing alarm symbol andverify the monitor Silencesthe alarm Changesthe active...

Страница 126: ...of the monitor check that the LED AC power indicator that appears above the power button is illuminated Onthetouchscreen verifytheplugiconappearsinthestatusbar 4 On the rearofthe monitor disconnect th...

Страница 127: ...ing tothe chargelevel that displaysthe Battery is low message 2 Keep running the monitor onbatterypower foranother 10minutes After 10 minutes verify that the monitor will Sound analarm containing a bu...

Страница 128: ...that appearson the status bar displaysthe electrical charge symbol 4 Pressthe power button again to turnoff the monitor Continue charging the batteryto full capacity The time forre chargingthe battery...

Страница 129: ...rdingto local regulations 5 Insertthe newbattery A Verifythe Natus Neuro logo on the batterylabel isfacing up B Align the battery sconnectors on the frontofthe batteryto theconnector slotson the monit...

Страница 130: ...Version Onthe touchscreen pressthe Settingstab andselectSystem Information Testing Synchronizing to Patient Bedside Monitor Performthe proceduresforsynchronizing the Camino ICP Monitor toa patient bed...

Страница 131: ...chnicalservice Domestic and International Natus Neurology Incorporated 3150 Pleasant View Road Middleton WI USA 53562 1 800 356 0007 madison helpdesk natus com Forservice and repairs outside the Unite...

Страница 132: ...r During this process Natus Neuro will also evaluate the battery susage number ofre charge cycles andcalibrationstatus andreplaceit withanew one if necessary To determine the nextduedate for annual ma...

Страница 133: ...0 Chargetime No more than 5hours while the monitor isplugged intoan AC power outlet andthe monitor isturnedoff Operationtime 1 5 hours Principle Technology Pressure Sensor Type Fiber optic pressuretra...

Страница 134: ...ange 51to 125mmHg 6 Temperature catheter 0 3 C Rated ICP Accuracy Range 10 to 125mmHg RatedTemperatureAccuracy Range Direct Mode measurement 30 Cto 42 C ProtectionAgainst Electric Shock Class II type...

Страница 135: ...operation The Camino ICPMonitor meetsthe electrical safetyrequirements for IEC 60601 14th edition andapplicable particular andcollateral standards EMI EMC IEC 60601 1 2 2014 IEC 60601 2 49 2011 Elect...

Страница 136: ...disabling ofthemonitor Portableandmobile RF communications equipment can affect medical electrical equipment Cables and accessories not specified within the instructions for use are not authorized Usi...

Страница 137: ...RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The EMISSIONS characteristics of Camino ICP Monitor make it suitabl...

Страница 138: ...nt Surge IEC 61000 4 5 0 5 kV 1 kV line s to line s 0 5 kV 1 kV 2 kV line s to earth 1 kV 2kV Mainspower quality should bethat ofa typical commercial or hospital environment Voltage dips short interru...

Страница 139: ...eters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vi...

Страница 140: ...GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5240 5500 5785 5100 5800 WLAN...

Страница 141: ...transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800MHz d 1 17 P 800 MHz to 2 7 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 1...

Страница 142: ...142 Blank page...

Страница 143: ...BELIABLE FOR ANYINCIDENTAL INDIRECT CONSEQUENTIAL ORPUNITIVE DAMAGES IN CONN ECTION WITH THE ACQUISITION ORUSEOFANY NATUS MEDICAL INCORPORATED PRODUCT Further this warrantyshallnot applyto andNatus N...

Страница 144: ...very opportunity toinspect andremedydefects 3 Repair Parts and Services 3 1 Included under the Warranty arethefollowing services 3 1 1 Modifications toCovered Equipment From time totime at itssole dis...

Страница 145: ...uro or its representatives Customer shallbe fully responsiblefor all treatments performed or attemptedwiththeEquipment NATUS MEDICAL INCORPORATED MAKES NO REPRESENTATION OR WARRANTY AS TO THE EFFICACY...

Страница 146: ...146 Blank page...

Страница 147: ...93 Conditions that Reset Trend Data 63 Connecting to a Patient Bedside Monitor 50 Contact Information 4 Contraindications 17 Copyright Information 3 Customizing the User Settings 69 Data Extraction 87...

Страница 148: ...ical Support and Annual Maintenance 131 Temperature 65 Testing and Preventative Maintenance 111 Temperature Transducer Connector Test Circuit Diagram 120 Testing AC Power and Battery Charge 126 Testin...

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