Nellcor OXIMAX N-600X Series Operator'S Manual Download Page 210

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Index

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N-600x Operator’s Manual

Summary of Contents for OXIMAX N-600X Series

Page 1: ......

Page 2: ...anadian ICES 001 Cet appareil ISM est conforme la norme NMB 001 Canada To obtain information about a warranty if any contact Nellcor s Technical Services Department or your local representative Purcha...

Page 3: ...y 11 Blip Display 12 Real Time Trend Display 14 SpO2 and Pulse Rates 14 About the Visual Indicators 16 About the Audible Indicators 19 Setting Up the Monitor 21 List of Components 23 Connecting to an...

Page 4: ...dult Pediatric or Neonatal Settings 61 Setting Patient Adult Pediatric or Neonatal Modes 62 Alarm Limit Changed Indicator 63 Setting Alarm Limits 63 Setting SatSeconds Alarm Limit 65 Setting Monitor R...

Page 5: ...e Display Printout Format 103 Column Headings 105 Data Source 105 Software Version 106 Alarm Limits 106 Monitor Mode 106 Response Mode 107 Data Column Headings 107 Time 108 Patient Data 108 Operating...

Page 6: ...Single Topics 143 Error Codes 145 Prompts and Error Messages 148 Primary Speaker Failure 151 Help and Support 153 EMI Electromagnetic Interference 158 Obtaining Technical Assistance 159 Returning you...

Page 7: ...easured versus Calculated Saturation 174 OXIMAX Technology 175 Functional Testers and Patient Simulators 176 Specifications 177 Performance 177 Electrical 178 Environmental Conditions 180 Physical Cha...

Page 8: ...Contents vi...

Page 9: ...of the date time is the responsibility of the N 600x It is recommended that the N 600x user set the time date to the correct value before a sensor event record enabled sensor is connected and that thi...

Page 10: ...d pulse signals can be affected by certain environmental conditions OXIMAX sensor application errors and certain patient conditions See the appropriate sections of this manual for specific safety info...

Page 11: ...for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 60601 1 1 systems requirements Anyone who connects additional equipment to the signal input port or...

Page 12: ...Safety Information 4 N 600x Operator s Manual...

Page 13: ...nd home environments For prescription use only Note Hospital use typically covers such areas as general care floors operating rooms special procedure areas intensive and critical care areas within the...

Page 14: ...All users should read this manual thoroughly More experienced users of the N 600x can directly go to the topics for the information they require This manual is available on the Internet at http www m...

Page 15: ...er Indicator page 16 14 Neonate Mode Indicator page 18 4 ON STANDBY Button page 10 15 HELP CONTRAST Button page 11 5 Battery Fuel Gauge Indicator page 34 16 Fast Response Mode Indicator page 18 6 Wave...

Page 16: ...icators 8 N 600x Operator s Manual About the Rear Panel Figure 2 Rear Panel Components 1 Equipotential Terminal Ground 2 AC Power Connector page 24 3 Data Port Connector page 112 4 Fuse Holder 5 Suppl...

Page 17: ...Symbols The symbols located on the rear panel of the N 600x are as follows Table 1 Symbols and Descriptions Symbol Description See Instructions for Use Fuse Replacement Equipotential Terminal ground D...

Page 18: ...ualified service personnel ALARM SILENCE Button Silences current alarms for the alarm silence duration period When an alarm has been silenced pressing the button again reactivates or unsilences the al...

Page 19: ...LP CONTRAST button launches the on screen help Pressing and holding the HELP CONTRAST button while simultaneously pressing the ADJUST UP and ADJUST DOWN buttons lightens or darkens the display screen...

Page 20: ...rent measurement When the monitor is powered by the internal battery the pleth display includes a horizontal battery fuel gauge positioned in the upper left corner which shows the remaining charge ope...

Page 21: ...battery fuel gauge positioned in the upper left corner that shows the remaining charge operating hours on battery If a monitor reporting a low battery is connected to AC power the battery fuel gauge s...

Page 22: ...nabled the real time trend display includes the SatSeconds indicator Decimal points after the displayed SpO2 or pulse rate indicate that the respective limits have been changed from the power on defau...

Page 23: ...00x algorithm automatically extends the amount of data required beyond 7 seconds If the resulting dynamic averaging time exceeds 20 seconds the pulse search indicator is lit solid and SpO2 and Pulse R...

Page 24: ...each pulse This indicator is available only in the blip view Plethysmographic Waveform Display Displays a non normalized waveform in real time sensor signals The relative pulsatile strength and qualit...

Page 25: ...et to Off Interference Indicator Lights whenever the N 600x algorithm detects the incoming signal quality is degraded Note Degradation can be caused by ambient light electrical noise electro surgical...

Page 26: ...the indicator is full a medium priority alarm sounds Fast Response Mode Indicator Determines the response time 2 to 4 seconds in fast mode and 5 to 7 seconds in normal mode applied by the OXIMAX algo...

Page 27: ...rrent state of the monitor Valid Button Press Short medium pitched tone indicating an appropriate button has been pressed High Priority Alarm High pitched fast pulsing tone indicating loss of pulse No...

Page 28: ...age 20 Piezo Tone A high pitched piezo tone is sounded if there is no user response to an audible alarm or if the monitor detects a failure of the primary speaker See High Medium and Low Priority Alar...

Page 29: ...lt in an inaudible alarm tone WARNING Disconnect the N 600x and Nellcor OXIMAX sensor from the patient during magnetic resonance imaging MRI scanning Objects containing metal can become dangerous proj...

Page 30: ...tlet controlled by a wall switch because the pulse oximeter may be accidentally turned off WARNING Use only the Nellcor pulse oximetry cable DOC 10 with the N 600x pulse oximeter Use of another pulse...

Page 31: ...em 1 N 600x Pulse Oximeter 1 Nellcor OXIMAX Sensor or Assortment Pack 1 DOC 10 Pulse Oximetry Cable 1 N 600x Operator s Manual applicable to country of sale and or compact disc 1 Power Cord applicable...

Page 32: ...on The Supply Voltage Selector switch must be set to the correct voltage 115 or 230 to avoid equipment damage and ensure battery charging Caution Use only the hospital grade power cord provided by Nel...

Page 33: ...qualified electrician to examine the outlet for ground connections 4 Verify the monitor s AC power indicator is lit Note If the AC power indicator is not lit check the power cord supply voltage select...

Page 34: ...only Nellcor approved OXIMAX sensors and pulse oximetry cables Note Physiological conditions medical procedures or external agents that may interfere with the monitor s ability to detect and display m...

Page 35: ...used when the battery is depleted unless the monitor is connected to an AC power source A warning message displays and must be cleared by pressing the ALARM SILENCE button before the monitor can be us...

Page 36: ...d battery and the AC power is subsequently lost the monitor will shut down immediately When all of the following conditions are present for 15 minutes the N 600x automatically shuts down Monitor is ru...

Page 37: ...off during a low battery condition the backlight cannot be turned back on Nellcor recommends that a qualified service personnel replace the internal battery every 24 months Replaced batteries should b...

Page 38: ...ttery AC Power Operation 1 No No Yes SpO2 normal AC Battery charge LED on LOW BATTERY LED off LOW BATTERY message off Audible alarm off Error code none Effect of ALARM SILENCE key normal Shutdown N A...

Page 39: ...audio alarm second press cancels LOW BATTERY message LED stays on until Low Battery Condition is corrected Shutdown Imminent 4 No Yes Yes SpO2 normal AC Battery charge LED on LOW BATTERY LED on LOW BA...

Page 40: ...No SpO2 not displayed AC Battery charge LED off LOW BATTERY LED on flashing LOW BATTERY message on Audible alarm high priority Error code displayed and logged Effect of ALARM SILENCE key none Shutdown...

Page 41: ...w UNIT WILL SHUT DOWN IF AC POWER LOST Audio alarm low priority Error code logged Affect of Silence key One press silences the audible alarm Pressing the Affect Silence key twice cancels the LOW BATTE...

Page 42: ...evels in Table 5 are based on a brand new battery As a battery is used and recharged over time it may provide only 75 of the capacity of brand new battery For example a battery that is two years old m...

Page 43: ...includes BACK softkey options that enable you to move back to the previous menu level without exiting the Trend menu entirely Trend data must be compiled on entry reentry to the Trends menu When the s...

Page 44: ...XIT to Main menu BACK back to Monitor Trend View menu EXIT to Main menu ZOOM Monitor Trend Zoom Menu TIME Cycle through 48h 36h 24h 12h 8h 4h 2h 1h 30m 15m 40s 20s for current view SCALE Cycle through...

Page 45: ...scroll through events in order show previous graph only available when there is a previous graph show next graph only available when there is a next graph PRINT BACK back to Sensor menu TABLE Table Me...

Page 46: ...nsor sensor are SPO2 SPO2 BPM DEFAULT On screen options for SENSOR RW rewritable sensor are SPO2 SPO2 BPM DEFAULT SELECT toggles SENSOR R or SENSOR RW sensor type up down keys scroll through options i...

Page 47: ...uration Menu SELECT BACK back to Communication Language menu EXIT to Main menu NCALL Nurse Call Menu NORM NORM BACK back to Communication Nurse Call menu EXIT to Main menu NEXT Analog Mode Menu ANALOG...

Page 48: ...n individual basis by the clinician and these settings remain in effect until the monitor is turned off Table 6 Parameter Ranges Parameter Ranges Selections Factory Adult Defaults Factory Neonate Defa...

Page 49: ...al Time Trend Pleth Pleth Display Contrast Low to high Medium Medium Language English Danish Dutch Finnish French German Norwegian Portuguese Spanish Italian Swedish English English Limits Adult Neona...

Page 50: ...se Call Polarity Normally High Normally Low Normally Low Normally Low SatSeconds Off 10 25 50 100 Off Off Allow SatSeconds Yes No Yes Yes Sensor Event Date Format SENSOR R and SENSOR R W SpO2 SpO2 Pul...

Page 51: ...cal procedures or external agents that may interfere with the monitor s ability to detect and display measurements include dysfunctional hemoglobin arterial dyes low perfusion dark pigment and externa...

Page 52: ...s often needed when calling Nellcor s Technical Services Department or your local Nellcor representative for technical assistance Record the software version number and have it available prior to cont...

Page 53: ...unds cannot be heard OXIMAX Sensor Attached WARNING Do not use any other cables to extend the length of the DOC 10 Pulse Oximetry Cable Increasing the length of the DOC 10 cable will degrade signal qu...

Page 54: ...pe settings are SpO2 and SPO2 BPM Note The type of data recorded is only displayed when data is present in the OXIMAX sensor The monitor displays zeros in the SpO2 and Pulse Rate displays while the N...

Page 55: ...thysmographic waveform or beating heart indicating the monitor is displaying real time data Listen for the pulse beep tone If the pulse beep tone does not sound with each pulse it is an indication the...

Page 56: ...and a poor signal condition message displays on the monitor screen At this point the monitor displays 3 dashes 3 dashes and remains in the Pulse Search Mode for five seconds before displaying the poo...

Page 57: ...ched Upon successful completion of the POST process the monitor sounds a one second tone indicating that the monitor has passed the POST or The monitor displays dashes and the Pulse Search indicator i...

Page 58: ...M SILENCE button any alarm Adjusting the Screen Contrast 1 With the monitor in the normal monitoring mode press and hold the HELP CONTRAST button while pressing the ADJUST UP or ADJUST DOWN button unt...

Page 59: ...tion of the pleth waveform 1 With the monitor in the normal monitoring mode press the SETUP softkey 2 Press the VIEW softkey 3 Press the PLETH softkey The pleth view displays Selecting the Blip View T...

Page 60: ...displays the SpO2 and or pulse rate trend data The real time trend submenu enables you to select the trend data display set the trend time scale display and set the trend amplitude scale display 1 Wi...

Page 61: ...the VIEW softkey 5 Press any of the trend softkeys DUAL SPO2 or PULSE Setting the Trend Time Scale Display 1 Press the SETUP softkey 2 Press the VIEW softkey 3 Press the TREND softkey 4 Press the ZOOM...

Page 62: ...e newest rightmost trend data point Note You can set the trend amplitude scale to AUTO by pressing the AUTO softkey The maximum trend data point is rounded up to the nearest multiple of 10 shown at th...

Page 63: ...just the volume of alarm tones 1 With the monitor in the normal monitoring mode press the ALARM SILENCE button until the alarm volume level displays and sounds on the monitor 2 While continuing to pre...

Page 64: ...sensor is connected and that this date time not be changed while the sensor remains connected Since a sensor with sensor event record data can be transported from one monitor to another having discre...

Page 65: ...ess the SELECT softkey to select the TIME and DATE fields as shown in the graphic below TIME HOURS MINUTES SECONDS 16 46 05 DATE DAY MONTH YEAR 02 JAN 06 6 Use the ADJUST UP or ADJUST DOWN buttons to...

Page 66: ...button until the alarm silence duration setting displays The alarm silence durations available are 30 60 90 and 120 seconds 2 Press and hold the ALARM SILENCE button and the ADJUST UP button to incre...

Page 67: ...600x Service Manual is available on the Internet at http www mallinckrodt com respiratory resp Serv_SuppProductManuals html WARNING Do not disable the audible alarm function or decrease the audible a...

Page 68: ...standby mode setting is used when a patient has to temporarily leave the monitor 1 Verify the N 600x is monitoring a patient and the alarm limits are configured to the patient being monitored 2 Disco...

Page 69: ...factory default power on setting is for adult pediatric patients This default setting can be changed to neonatal by qualified service personnel using the procedures indicated in the N 600x Service Ma...

Page 70: ...de press the LIMITS softkey The monitor displays the ADULT LIMITS or NEONATE LIMITS screen depending on the patient setting used 2 Press the NEO or ADULT softkey to select ADULT LIMITS or NEONATE LIMI...

Page 71: ...lower saturation and pulse rate limits It also enables you to adjust the SatSeconds limit The Alarm Limit display is accessed by pressing the LIMITS softkey on the main menu The Alarm Limit display i...

Page 72: ...or Neonatal alarm limits screen 3 Press the SELECT softkey to select the parameter to be adjusted 4 Use the ADJUST UP or ADJUST DOWN buttons to increase or decrease the selected limit parameter 5 Rep...

Page 73: ...ed service personnel by following the procedures outlined in the N 600x Service Manual Setting SatSeconds Alarm Limit Refer to Using SatSeconds on page 163 for more information on the SatSeconds featu...

Page 74: ...correspond with the SpO2 calculation response time The response mode automatically programs the N 600x algorithm to record and display monitor trend information at 2 second intervals Fast Mode up to 2...

Page 75: ...E softkey Note When the monitor is in the fast response mode the monitor may produce more SpO2 and pulse rate alarms than you are accustomed to experiencing 4 Use the ADJUST UP or ADJUST DOWN buttons...

Page 76: ...various languages The languages available are ENGLISH DANSK Danish DEUTSCH German ESPA OL Spanish FRANCAIS French ITALIANO Italian NEDERLANDS Dutch NORSK Norwegian PORTUG Portuguese SUOMI Finnish SVE...

Page 77: ...sensor adjust messages which when enabled are displayed when the monitor is not able to display saturation When OXIMAX sensor messages are displayed it is an indication that the OXIMAX sensor is funct...

Page 78: ...eens may be required to display all of the messages When multiple screens are required navigation between screens can be accomplished by using the NEXT BACK and EXIT softkeys OXIMAX sensor messages ma...

Page 79: ...R SENSOR SITE Message EAR FOREHEAD SENSOR Message NASAL EAR SENSOR Message OXIMAX ADHESIVE SENSOR Message SECURE CABLE Message HEADBAND Message WARM SITE Message BANDAGE ASSEMBLY Message NAIL POLISH M...

Page 80: ...Using the Monitor 72 N 600x Operator s Manual...

Page 81: ...is stored in the monitor Monitor trend displays are accessed by pressing the TREND softkey on the main menu and selecting the MONITR softkey option The monitor trend submenu enables you to choose whic...

Page 82: ...allows you to view one hour of trend information By using the scrolling feature any one hour of trend data can be viewed up the 48 hours of trend information The ADJUST DOWN button scrolls the displa...

Page 83: ...itional alarm limit changes will take space reserved for trend data Caution Changing alarm limit settings uses up trend memory space Change alarm limits only as needed Note Trend memory always contain...

Page 84: ...messages in the OXIMAX sensor message s function This display is the first message displayed when an OXIMAX sensor is connected to the monitor Selecting the Trend Data Display Scale The trend scale i...

Page 85: ...ints 25 points 30 points 35 points 40 points and 50 points above and below the data point under the cursor The saturation graphical monitor trend display vertical scale default setting is from 10 to 1...

Page 86: ...the screen Settings available are 20 and 40 seconds 15 and 30 minutes 1 2 4 8 12 24 36 and 48 hours 2 Date represented by the cursor item 5 3 No trend data recorded during this time 4 Time represented...

Page 87: ...trend data display shows both oxygen saturation SpO2 levels and pulse rate bpm trend data 1 With the monitor in the normal monitoring mode press the TREND softkey 2 Press the MONITR softkey 3 Press t...

Page 88: ...normal monitoring mode press the TREND softkey 2 Press the MONITR softkey 3 Press the VIEW softkey 4 Press the SPO2 softkey SpO2 trend data displays Pulse Rate Trend Display 1 With the monitor in the...

Page 89: ...on SpO2 and pulse rate bpm The data displayed represents the trend data stored over the period of time indicated on the display Refer to OXIMAX Sensor Type on page 76 to set up the desired trend data...

Page 90: ...e amplitude trend data display shows the amplitude of the patient s pulse rate over the period of time indicated on the display Refer to OXIMAX Sensor Type on page 76 to setup the desired trend data s...

Page 91: ...e The cursor moves right or left using the ADJUST UP right and ADJUST DOWN left buttons Clearing Trend Information 1 With the monitor in the normal monitoring mode press the TREND softkey 2 Press the...

Page 92: ...Using Monitor Trend Data 84 N 600x Operator s Manual...

Page 93: ...inate this possible problem all monitors within an institution should be set to the same time The adhesive OXIMAX sensors are capable of storing patient alarm event data A sensor event record allows a...

Page 94: ...d by pressing the TREND softkey on the main menu and selecting the SENSOR softkey option Sensor event record can be viewed in graphical form GRAPH or in a summary table TABLE Note Once the OXIMAX sens...

Page 95: ...or disable the OXIMAX sensor message feature When disabled neither the SENSOR NOT POSTING nor the RECOMMENDED ACTION messages display 1 With the monitor in the normal monitoring mode press the SETUP...

Page 96: ...e monitor turned on and no cables attached to the SpO2 OXIMAX sensor port press the SETUP softkey 2 Press the SENSOR softkey 3 Press the DATA softkey Note OXIMAX sensor data type settings are displaye...

Page 97: ...X sensor with no previously recorded patient data is connected to the OXIMAX monitor a DATA TYPE message is displayed briefly at the bottom of the display after the OXIMAX sensor type message The mess...

Page 98: ...approximately 60 seconds or until the OXIMAX sensor is disconnected or until the sensor trend data is displayed by pressing TREND then SENSOR A corresponding DATA IN SENSOR message is also displayed...

Page 99: ...MAX sensor is disconnected OXIMAX Sensor Event Record Not Available If you select the TREND SENSOR option when a connected OXIMAX sensor single patient use OXIMAX sensors only does not contain data be...

Page 100: ...e equals or exceeds the alarm threshold The duration of an event is determined by the number of data points in the event Each data point is stored at 30 second intervals Events end due to one of the f...

Page 101: ...graph The first data point is the alarm threshold Events are displayed one at a time and one per graph Graphs are displayed in chronological sequence with the most recent event shown first when acces...

Page 102: ...istory data The monitor protocol must be set to GRAPH to print the in sensor event history data Refer to Printing Monitor Trend Data on page 99 1 Connect an OXIMAX sensor containing patient data to th...

Page 103: ...of SpO2 BPM saturation plus pulse rate dual view event graphs are shown below The dual view graph is the same as a single graphical event history graphs except the graphs are compressed horizontally...

Page 104: ...tabular Event Summary display is first accessed Four events can be displayed simultaneously the table must be scrolled to view additional events You can move to the next screen view of the table the n...

Page 105: ...s TREND SENSOR submenu level Viewing and Printing In Sensor Tabular Event History Data 1 With the monitor in the normal monitoring mode press the TREND softkey 2 Press the SENSOR softkey 3 Press the T...

Page 106: ...Using OXIMAX Sensor Event Records 98 N 600x Operator s Manual...

Page 107: ...to a serial printer Note The protocol settings must be set to ASCII MODE for printing text data or GRAPH MODE for printing graphical data Printing 1 With the monitor in the normal monitoring mode con...

Page 108: ...on 6 Press the SELECT softkey to select PROTOCOL 7 Set the PROTOCOL to ASCII for text printing or GRAPH for graph printing using the ADJUST UP button 8 Press the EXIT softkey 9 Press the TREND softkey...

Page 109: ...Printing Monitor Trend Data N 600x Operator s Manual 101 12 Press the PRINT softkey ASCII printout GRAPH printout...

Page 110: ...displayed in 2 or 4 second intervals depending on the response mode selected The values on each row are an average of the response mode selected period At the end of the printout an Output Complete l...

Page 111: ...through the data port by connecting the monitor data port to a PC or serial printer When a real time printout or display is being transmitted to a printer or PC a new line of data is displayed every 2...

Page 112: ...Printing Monitor Trend Data 104 N 600x Operator s Manual An example of real time data output is shown in Figure 5 Figure 5 Real Time Printout...

Page 113: ...here are three column heading lines shown in the printout Using the top row as the starting point there are 25 lines before the second row of column headings is printed The third row of column heading...

Page 114: ...may change if the monitor is serviced and receives a software upgrade Alarm Limits The last data field in the top line indicates the upper and the lower alarm limits for SpO2 and for the pulse rate P...

Page 115: ...nse mode NORMAL or FAST is identified on the printout Data Column Headings Actual column headings are in the second row of the column heading line Patient data presented in the chart from left to righ...

Page 116: ...00 and the pulse rate is 190 beats per minute The next to the 190 indicates that 190 beats per minute is outside of the alarm limits indicated in the top row for pulse rate If no data for a parameter...

Page 117: ...codes can be displayed at one time in the Status column Note An OXIMAX sensor disconnect causes three dashes to be displayed in the patient data section of the display or printout Code Definition AO...

Page 118: ...Printing Monitor Trend Data 110 N 600x Operator s Manual...

Page 119: ...grounded AC power outlet The N 600x protocol setting must be ASCII Any printer or PC connected to the monitor s data port must be certified according to IEC Standard 950 All combinations of equipment...

Page 120: ...0 The cable used must have a braided shield that provides 100 coverage such as a Belden cable Belden part number 9609 or equivalent The shield must have a 360 degree connection to the metal shell on t...

Page 121: ...vide data in RS 422 format TxD and TxD are the differential transmit data pair RxD and RxD are the differential receive data pair 5 Signal Ground isolated from Earth Ground 6 AN_SpO2 analog saturation...

Page 122: ...lay to set the baud rate and the protocol of the data port on the N 600x The Data Port Setup display is accessed by pressing the COMM softkey on the Setup menu 1 With the monitor in the normal monitor...

Page 123: ...s Manual 115 5 Press the ADJUST UP or ADJUST DOWN buttons to select the desired protocol The available protocols are ASCII CLINICAL GRAPH OXINET PHILIPS SPACELBS Spacelabs MARQ GE Marquette DATEX Dat...

Page 124: ...or 15 as indicated in Table 8 The N 600x provides two different types of nurse call interfaces an RS 232 level and relay closure The RS 232 level nurse call function operates when the monitor is conne...

Page 125: ...monitor displays 3 dashes in the SpO2 and pulse rate display One way to test the nurse call function is to create an alarm condition for example sensor disconnect and verify that your facility s nurse...

Page 126: ...6 13 14 and ground pin 10 which can be used to calibrate instruments such as a chart recorder The voltage represents a specific measured parameter s current value The voltage differential varies propo...

Page 127: ...r at pins 6 13 or 14 as referenced to ground pins 5 and 10 Selecting the STEP softkey causes the voltage to increase from 0 to 1 volt at 1 10th volt increments with each step lasting at least 1 second...

Page 128: ...Using the Data Port 120 N 600x Operator s Manual...

Page 129: ...in the date time between monitors and the sensor event record data will affect the order the sensor event record data appears To eliminate this possible problem all monitors within an institution shou...

Page 130: ...es with this pulse oximeter Other sensors or pulse oximetry cables may cause improper N 600x performance WARNING Do not attach any cable to the OXIMAX sensor port connector that is intended for comput...

Page 131: ...esive OXIMAX sensors are intended for single patient use only Do not transfer an adhesive sensor containing sensor trend data from one patient to a second patient Doing so may result in data from the...

Page 132: ...135 for more information on OXIMAX sensor performance Table 10 Nellcor OXIMAX Sensor Models and Patient Sizes OXIMAX Sensor Model Patient Size OXIMAX MAX FAST adhesive reflectance oxygen sensor MAX F...

Page 133: ...r clip Reusable nonsterile Pedi CheckTM pediatric spot check clip Reusable nonsterile D YS D YSE D YSPD 1 kg 30 kg 3 to 40 kg OXIMAX Softcare nonadhesive sensor single patient use preterm infant SC PR...

Page 134: ...sting Biocompatibility testing has been conducted on Nellcor OXIMAX sensors in compliance with ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing The OXIMAX sensors hav...

Page 135: ...rtment or your local Nellcor representative for information about these accessories GCX Mounting Plate See Figure 7 on page 128 GCX Vertical Wall Mount Arm See Figure 8 on page 129 GCX Roll Stand See...

Page 136: ...ally available GCX mount brackets and is used to securely mount the N 600x to a wall bracket or a roll stand The mounting plate attaches to the bottom of the N 600x as shown in Figure 7 For further in...

Page 137: ...available and can be ordered separately for the N 600x The vertical wall mount arm attaches to the N 600x GCX mounting plate as in in Figure 8 For further instructions regarding connecting the vertica...

Page 138: ...with an attached handle is available from Nellcor for the N 600x The GCX roll stand attaches to the N 600x GCX mounting plate as shown in Figure 9 For further instructions regarding connecting the GCX...

Page 139: ...ng case is available from Nellcor for the N 600x See Figure 10 The padded carrying case protects the N 600x while transporting the monitor The carrying case contains two pockets for OXIMAX sensors cab...

Page 140: ...OXIMAX Sensors and Accessories 132 N 600x Operator s Manual...

Page 141: ...onditions See the appropriate sections of the manual for specific safety information Safety Information on page 1 OXIMAX Sensors and Accessories on page 121 Performance Considerations on page 133 Over...

Page 142: ...nctional hemoglobins poor peripheral perfusion excessive patient activity venous pulsations intravascular dyes such as indocyanine green or methylene blue externally applied coloring agents nail polis...

Page 143: ...ys pulse rates between 20 and 250 bpm Detected pulse rates above 250 bpm are displayed as 250 Detected pulse rates below 20 are displayed as 0 OXIMAX Sensor Performance Considerations WARNING Pulse ox...

Page 144: ...s the one with the OXIMAX sensor attached there is arterial occlusion proximal to the OXIMAX sensor poor peripheral profusion Select an appropriate OXIMAX sensor apply it as directed and observe all w...

Page 145: ...X sensor is properly and securely applied move the OXIMAX sensor to a less active site use an adhesive OXIMAX sensor that improves patient skin contact use a new OXIMAX sensor with fresh adhesive back...

Page 146: ...Performance Considerations 138 N 600x Operator s Manual...

Page 147: ...ages and how to obtain technical help and support WARNING If you are uncertain about the accuracy of any measurement check the patient s vital signs by alternate means then make sure the pulse oximete...

Page 148: ...the on screen help Accessing Multiple Topics You can access multiple on screen help topics and select a specific topic to view Follow the example described below to access the SatSeconds help topic 1...

Page 149: ...IN window press ADJUST DOWN t to select SATSECONDS and then press SHOW The HELP SATSECONDS window appears The SatSeconds help topic contains a total of six consecutive help windows 4 Press the NEXT so...

Page 150: ...42 N 600x Operator s Manual 6 Press NEXT 7 Press NEXT 8 Press NEXT 9 Press BACK to view the previous windows Continue to press BACK to return to the HELP MAIN window 10 Press EXIT to return to the mon...

Page 151: ...e example described below to access the SatSeconds help topic 1 Press LIMITS on the monitor Main menu and then SELECT to highlight SAT S SatSeconds 2 Press the HELP CONTRAST button The HELP LIMITS win...

Page 152: ...BACK 6 Press ADJUST DOWN t to highlight NEO and then press SHOW The HELP LIMITS NEO window appears 7 Press BACK 8 Press ADJUST DOWN t to highlight ADULT and the press SHOW The HELP LIMITS ADULT window...

Page 153: ...hen an error code other than the ones listed in Table 12 is displayed turn the instrument off and back on again If the error code reappears record it and notify service personnel Below Table 12 lists...

Page 154: ...lt settings turn the monitor off and back on again and reenter the desired settings 82 CLOCK SETTING LOST The date and time settings have been lost Reenter the date and time Recharge or replace the ba...

Page 155: ...is being operated within specified environmental conditions Notify a qualified service technician 717 718 BATTERY FAILURE The monitor has detected a battery open or short condition The monitor will s...

Page 156: ...aximum time that the message remains displayed If Time out is None the message remains displayed until the condition is corrected or until an exit event occurs Some messages close when the ALARM and o...

Page 157: ...TA IN SENSOR 5 No Yes When a sensor containing data is connected to the monitor On time out sensor disconnect or pressing the ALARM SILENCE button whichevercomes first DATA TYPE SPO2 BPM 5 No Yes When...

Page 158: ...any audible tone and the second press clears the message READING TRENDS None Yes Yes When the N 600x needs more than 4 to 6 seconds to retrieve trend data from memory When sensor data is completely r...

Page 159: ...the ALARM SILENCE button to silence the slow pulsing piezo tone Note Once the monitor is silenced the N 600x sounds a piezo tone every three minutes as a reminder of the primary speaker failure condi...

Page 160: ...NG If an N 600x reports a primary speaker failure do not use the monitor longer than necessary to ensure patient safety Contact a qualified service personnel your local Nellcor representative or Nellc...

Page 161: ...rect it contact qualified service personnel or your local Nellcor representative The N 600x Service Manual which is for use by qualified service personnel provides additional troubleshooting informati...

Page 162: ...If the battery is discharged charge the battery see Operating on Battery Power on page 27 If the battery does not charge notify a service personnel to replace the battery One or more display elements...

Page 163: ...er type of OXIMAX sensor Interference may be preventing the N 600x from tracking the pulse Keep the patient still if possible Verify that the OXIMAX sensor is securely applied and replace it if necess...

Page 164: ...is securely applied and replace it if necessary Change the OXIMAX sensor site Use a type of OXIMAX sensor that tolerates more patient movement for example an adhesive OXIMAX sensor Electromagnetic in...

Page 165: ...e battery discharges to a critically low level Ensure the SUPPLY VOLTAGE SELECTOR switch on the rear panel is set to the proper voltage based on your location Press the ON STANDBY button and allow the...

Page 166: ...vice The N 600x is designed for use in environments in which the pulse can be obscured by electromagnetic interference During such interference measurements may seem inappropriate or the monitor may n...

Page 167: ...es the power on self test Write the number down and have it available whenever requesting technical assistance Returning your Monitor Contact Nellcor s Technical Services Department 1 800 635 5267 or...

Page 168: ...Troubleshooting 160 N 600x Operator s Manual...

Page 169: ...emoved only by qualified service personnel There are no user serviceable parts inside The N 600x requires no calibration The battery should be replaced at least every 24 months Refer to the N 600x Ser...

Page 170: ...her a commercial nonabrasive cleaner or a solution of 70 alcohol in water and lightly wiping the surfaces of the monitor The N 600x may be disinfected using a soft cloth saturated with a solution of 1...

Page 171: ...per and lower alarm limits are set in the same way as with traditional alarm management The clinician also sets a SatSeconds limit that allows the monitoring of SpO2 below the selected low alarm limit...

Page 172: ...ints and remains there for a period of 2 seconds 2 points x 2 seconds 4 SatSeconds The SpO2 then drops to 86 for 3 seconds and then to 84 for 6 seconds The resulting SatSeconds are After approximately...

Page 173: ...w the limit but not staying below the limit long enough for the SatSeconds time setting to be reached When 3 or more limit violations occur within 60 seconds an alarm sounds even if the SatSeconds tim...

Page 174: ...Using SatSeconds 166 N 600x Operator s Manual...

Page 175: ...an change default settings Neonate Default Settings Table 15 Neonate Factory Defaults Parameter Setting Monitoring Mode Neo SpO2 Lower Alarm Limit 85 SpO2 Upper Alarm Limit 95 Allow silence duration t...

Page 176: ...e Trend Display SpO2 Real Time Trend Scale 30 Minutes Response Mode Normal SatSeconds Off Allow SatSeconds Yes Trend Display SpO2 Trend Scale 2 Hours Table 15 Neonate Factory Defaults Parameter Settin...

Page 177: ...st Midrange Display Format Pleth Language English Nurse Call Polarity Normally Low Pulse Beep Volume 5 of 6 Pulse Rate Lower Alarm Limit 40 bpm Pulse Rate Upper Alarm Limit 170 bpm Real Time Trend Dis...

Page 178: ...Factory Default Settings 170 N 600x Operator s Manual...

Page 179: ...Because a measurement of SpO2 is dependent upon light from the OXIMAX sensor excessive ambient light can interfere with this measurement Specific information about ambient conditions OXIMAX sensor ap...

Page 180: ...t absorption by pulsatile arterial blood eliminating the effects of nonpulsatile absorbers such as tissue bone and venous blood Automatic Calibration Because light absorption by hemoglobin is waveleng...

Page 181: ...tect significant amounts of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin In contrast hemoximeters such as the IL482 report fractional saturation oxygenated hemoglobin expressed...

Page 182: ...calculated value may differ from the SpO2 measurement of a pulse oximeter This usually occurs because the calculated saturation was not properly corrected for the effects of variables that shift the r...

Page 183: ...chip checks it to make sure that there are no errors and then loads the data to begin monitoring As the pulse oximeter reads the information it displays the OXIMAX sensor model number This process on...

Page 184: ...ucing the complex optical interaction of the sensor and the patient s tissue These capabilities are beyond the scope of known bench top testers SpO2 measurement accuracy can only be evaluated in vivo...

Page 185: ...ange SpO2 1 to 100 Pulse Rate 20 to 250 beats per minute bpm Perfusion Range 0 03 to 20 Accuracy Tolerance Saturation Adult1 70 to 100 2 digits Neonate1 70 to 100 3 digits Low Perfusion2 70 to 100 2 d...

Page 186: ...ies to N 600x monitor performance Reading accuracy in the presence of low perfusion detected IR pulse modulation amplitude 0 03 1 5 was validated using signals supplied by a patient simulator SpO2 and...

Page 187: ...lly charged battery when monitor is placed in Shelf mode by qualified service personnel using the procedures indicated in the N 600x Service Manual After 4 months storage in Shelf mode the N 600x will...

Page 188: ...y 15 to 95 non condensing to be compliant with IEC 60601 1 sub clause 44 5 Transport and Storage not in shipping container Temperature 20 C to 60 C 4 F to 140 F Altitude 390 m to 5 574 m 1 280 ft to 1...

Page 189: ...AX N 52 5 mW OXIMAX MAX I 52 5 mW OXIMAX MAX P 52 5 mW OXIMAX MAX A 52 5 mW OXIMAX MAX AL 52 5 mW OXIMAX MAX R 52 5 mW OXIMAX Oxiband OXI A N 52 5 mW OXIMAX Oxiband OXI P I 52 5 mW OXIMAX Durasensor D...

Page 190: ...d on battery power Degree of protection Type BF Applied part Mode of operation Continuous N 600x resistant to liquid ingress IEC 60601 1 sub clause 44 6 for class IPX1 Drip Proof equipment Degree of S...

Page 191: ...1 sub clause 36 IEC EN 60601 1 2 second edition Radiated and conducted emissions EN 55011 Group 1 Class B Operation with electrical line voltage variations FDA Reviewer s Guide Magnetic field suscept...

Page 192: ...est IEC 60601 1 2 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floor should be wood concrete o...

Page 193: ...common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial and or hospital environment Table 18 Electromagnetic Immunity The N 600x is suitable for...

Page 194: ...erruptible power supply or battery 40 UT 60 dip in UT for 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds 5 U...

Page 195: ...d be measured in the intended installation location to assure that it is sufficiently low Table 18 Electromagnetic Immunity The N 600x is suitable for use in the specified electromagnetic environment...

Page 196: ...Note 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 pred...

Page 197: ...e 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 survey accuracy To assess the e...

Page 198: ...ordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with survey accuracy To assess the electromagnetic environment due...

Page 199: ...ance in Meters Separation Distance in Meters Separation Distance in Meters 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output p...

Page 200: ...61000 4 2 Electric fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Software download cable RS 232 serial 15 to 9 pin D 10 0 ft 3 m Non termi...

Page 201: ...SPR 11 Class B Group 1 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emission IEC 61000 3 3 Electrostatic discharge ESD IEC 61000 4 2 Electric fast transient burst IEC 61000 4 4 Surge...

Page 202: ...roup 1 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emission IEC 61000 3 3 Electrostatic discharge ESD IEC 61000 4 2 Electric fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Co...

Page 203: ...ons IEC 61000 3 2 Voltage fluctuations flicker emission IEC 61000 3 3 Electrostatic discharge ESD IEC 61000 4 2 Electric fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Conducted RF IEC 61000 4...

Page 204: ...Specifications 196 N 600x Operator s Manual...

Page 205: ...Gauge Indicator 34 capacities 34 Baud Rate Set 114 Biocompatibility Testing 126 Blip Display 12 Blip View 51 C Cables 192 Calculated Saturation 174 Calibration 161 Carrying Case Soft Sided 131 Cautio...

Page 206: ...ttons and Symbols 7 Functional Saturation 173 G GCX Mounting Plate 128 German 68 Graph Mode Printout 103 Graphical Sensor Event Record Data 92 H Help accessing single topics 143 multiple topics 140 Hi...

Page 207: ...etry Overview 171 P Parameter Ranges 40 Performance Considerations Pulse Oximeter 134 Sensor 135 Performance Verification 133 PH 109 PL 109 Pleth Display 12 Plethysmographic Waveform Display 16 Portug...

Page 208: ...6 Sensor Event Record Available 90 Sensor Event Record Not Available 91 Sensor Message Enable Disable 87 Sensor Message Setup 87 Sensor Off 109 Sensor Type 150 Setting SatSeconds Alarm Limit 65 Settin...

Page 209: ...utton Press 19 Volume Setting Tone 20 Transport Relative Humidity 180 Temperature 180 Trend Data Operation 75 Trend Data Display Reading 78 Trend Display Dual Trend 79 Histogram 81 Pulse Amplitude 82...

Page 210: ...Index 202 N 600x Operator s Manual...

Page 211: ......

Page 212: ...vision 4280 Hacienda Drive Pleasanton CA 94588 U S A Telephone Toll Free 1 800 635 5267 Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS U K Rx ONLY 2007 Nellcor Puri...

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