Nellcor N-395 Operator'S Manual Download Page 1

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Summary of Contents for N-395

Page 1: ...OPERATOR S MANUAL N 395 Pulse Oximeter Caution Federal law U S restricts this device to sale by or 011 the order of a physiciatl ...

Page 2: ... and Visual Indicators 8 Description of Audible Indicators 9 Setup 11 Unpacking and Inspection 11 Performance Verification 11 List Of Components I 1 Optional Accessories 12 Monitor Setup 18 General Warnings 18 Connecting The N 395 To AC Power 19 Operating on a Discharged Battery j 9 Language Selection 21 Sensors 23 Selecting a Sensor 23 Biocompatibility Testing 24 Performance Considerations 25 Sta...

Page 3: ...Net 37 Determining the Satseconds 37 Satseconds Display 38 Adjustable Settings 38 Pulse Beep Volume 38 Alarm Volume 39 Alarm Silence Duration 39 Disabling Audible Alarms 40 Alarm Silence Reminder 40 Menu 41 Menu Structure 41 Limits 42 Overview 42 Viewing Current Alarm Limits 42 Changing Alarm Limits 43 Alarm Limits Changed Indicator 46 Trend 46 View 48 Zoom 50 40 Second Trends Table 50 Next 51 Del...

Page 4: ...ce 71 Returning the N 395 71 Maintenance 71 Service 71 Periodic Safety Checks 72 Performance Verification 72 Cleaning 72 Specifications m m m 73 Performance 73 Measurement Range 73 Accuracy 73 Electrical 74 Instrument 74 Battery 74 Environmental Conditions 75 Transport And Storage in Shipping Container 75 Transport And Storage Not in Shipping Container 75 Operation 75 Physical Characteristics 75 C...

Page 5: ...rview 89 Connecting to the Data Port 89 Baud Rate 89 Setting Data Port Protocol 89 Real Time Display Format 90 Column Headings 91 Patient Data and Operating Status 93 Trend Data Printout ASCII Mode 94 Trend Data Printout Graph Mode 95 Nurse Call 95 Analog Outputs 97 lndex 99 ...

Page 6: ...leth View 30 Figure 10 Monitoring Mode Display Blip Magnified View 30 Figure 11 Alarm Response with Satseconds 36 Figure 12 Alarm Limits Selection 46 Figure 13 Sp02 Trend 47 Figure 14 Dual Trend Display 48 Figure 15 Sp02 Trend Display 49 Figure 16 Pulse Rate Trend Display 49 Figure 17 Histogram 50 Figure 18 AMP Trend Display 50 Figure 19 40 Second Trends 51 Figure 20 SpaceLabs Connection 55 Figure...

Page 7: ...u 45 Table 5 Trend Scale 47 Table 6 Factory Default Settings Adult 59 Table 7 Factory Default Settings Neonate 60 Table 8 Error Codes and Messages 66 Table 9 Settings Adjustments 77 Table 10 Data Port Pinouts 88 Table 11 Status Codes 94 Table 12 Voltage Between Pins 10 and I 1 96 Table 13 Analog Pinouts 97 ...

Page 8: ...a prescription device and is to be operated by qualified personnel only WARNING Pulse oximetry readings and pulse signal can be I affected by certain ambient environmental conditions sensor 1 application errors and certain patient conditions See the Iappropriate sections of the manual for specific safety information IWARNING Chemicals from a broken LCD display panel 1 1 are toxic when ingested Use...

Page 9: ...complies with the requirements of system standard IEC Standard 6011 1 8 and the electromagnetic compatibility system standard IEC Standard 601 1 2 The N 395 accuracy may degrade if it is connected to secondary 110 devices when the instrument is not connected to earth refereaace To ensure accurate readings consider the environmental conditions that are present and the condition of the patient See t...

Page 10: ... use only Hospital use typically covers such areas as general care floors operating rooms special procedure areas intensive and critical care areas within the hospital plus hospital type facilities such as surgicenters sub acute centers special nursing facilities and sleep labs outside of the hospital Intra hospital transport includes transport of a patient within the hospital or hospital type fac...

Page 11: ...lated into a measurement of functional oxygen saturation Sp02 Note For an explanation of functional versus fractional saturation refer to Principles of Operation Because a measurement of Sp02 is dependent upon light from the sensor excessive ambient light can interfere with this measurement Specific inforination about ambient environmental conditions sensor application and patient conditions is co...

Page 12: ... the front and rear views of the N 395 and identify displays controls and connectors SpO2 Sensor Port 10 AC Power Indicator 11 Power OdOff Button 12 Low Battery Indicator 13 Waveforin Display 14 SatSecona s Timer 15 SpOz Display 16 Pulse Rate Display 17 Alarm Silence Indicator 18 ALARM SILENCE Button ADJUST UP Button ADJUST DOWN Button CONTRAST Button Softkeys Menu Bar Motion Indicator Pulse Searc...

Page 13: ...rminal 3 Fuse Receptacle 2 Data Port Connector 4 Supply Voltage Selector Switch Figure 2 N 395 Rear Panel N 395 SYMBOLS i See Instructions for Use Fuse Replacement T 025A 250V Type BF Applied Part Not defibrillator proof wT Date of Manufacture Data Interface ...

Page 14: ...ST UP Button Used to increase alarm limit values alarin silence duration pulse beep voluine alarin volume contrast date and time values data port baud rate and to move the cursor to the right in the trend view The ADJUST DOWN Button Used to decrease alarm limit values alarin silence duration pulse beep volume alarm volume contrast date and time values data port baud rate and to move the cursor to ...

Page 15: ...displayed value flashes zeros during loss of pulse alarms and flashes the pulse rate value when pulse rate is outside of the alarm limits During Pulse Search the monitor continues to update the display If alarm limits have been changed from their power on defaults a decimal point is displayed after the pulse rate value 95 BpM 86 The Pulse Rate Display Shows the pulse rate in beats per minute It fl...

Page 16: ...system approaches the Satseconds alarm limit threshold DESCRIPTION OF AUDIBLE lNDllCATORS Followiiig are descriptions of N 395 audible indicators Power On Self Test Pass A l second tone indicating that the N 395 has been turned on and successfully coinpleted the power on self test Valid Button Press A short medium pitched tone indicating that an appropriate button has been pressed Invalid Button P...

Page 17: ...larms are silenced with the alarm silence duration set to OFF Pulse Beep A single beep sounds for each detected pulse The pitch changes as inonitored SpOz values increase or decrease Volume Setting Tone A continuous tone that is used to adjust the alarin volume Confirination Tone Three beeps sound to indicate that default settings have been saved or reset to factory defaults or trend data has been...

Page 18: ...r local Mallinckrodt representative PERFORMANCE VERIFICATION The N 395 performance can be verified by following the procedures outlined in the Performance Vevzjicationsection of the N 395 service manual Qualified service persoilnel should perform this procedure before using the monitor for the first time in a clinical setting LIST OF COMPONENTS 1 N 395 Pulse Oximeter 1 ellcor sensor or assortment ...

Page 19: ...nckrodt representative for infonnatioil about these accessories GCX Mounting Plate See Figure 3 page 13 e GCX Poly mount vertical wall mount with 19 inch channel See Figure 4 page 14 GCX Poly mount horizontal wall mount with rail adapter See Figure 5 page 15 GCX Roll Stand Poly mount See Figure 6 page 16 CCX Utility Basket See Figure 7 page 17 Soft Sided Carrying Case See Figure 8 page 18 ...

Page 20: ...ble GCX inount brackets and is used to securely mount the inonitor to a wall or roll stand The plate attaches to the bottom of the N 395 monitor as shown in Figure 3 For further instructions regarding connecting the plate to GCX brackets refer to the illustrated directioils for use included with the GCX mounting plate Figure 3 GCX Mounting Plate ...

Page 21: ...cal wall mount with 19 inch channel attaches to the N 395 monitor GCX mountiilg plate as shown in Figure 4 For further instructions regarding connecting the vertical wall mount with 19 inch channel refer to tl e illustrated directions for use included with the vertical wall mount with 19 inch channel Figure 4 GCX Poly mount vertical wall mount with 19 inch channel ...

Page 22: ...rizontal wall inount with rail adapter attaches to the N 395 monitor GCX mounting plate as shown in Figure 5 For further instructions regarding connecting the horizontal wall mount with rail adapter refer to the illustrated directions for use included with horizontal wall inount with rail adapter Figure 5 GCX Poly mount horizontal wall mount with rail adapter ...

Page 23: ...e W 395 The GCX roll stand poly mount attaches to the N 395 monitor GCX mounting plate as shown in Figure 6 For further instructions regarding connecting the GCX roll stand poly mount refer to the illustrated directions for use included with GCX roll stand poly mount Figure 6 GCX Roll Stand Poly mount ...

Page 24: ...rodt for the N 395 The CCX utility basket attaches to the GCX roll stand poly mount as shown in Figure 7 For further instructions regarding connecting the GCX utility basket refer to the illustrated directions for use included with GCX utility basket Figure 7 GCX Utility Basket ...

Page 25: ...he carrying case coiitains two pockets for sensors cables and operator9 s manual Figure 8 Soft Sided Carrying Case MONITOR SETUP General Warnings WAWZNG To ensure patient safety do not place the monitor in any position that might cause it to fall on the patient WARWING As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation ...

Page 26: ...the readings may be inaccurate during use and shortly thereafter Connecting the N 395 to AC Power The N 395 operates on AC power when the hospital grade power cord is connected to both the inonitor and an AC power source wall outlet The supply voltage selector switch allows connection of the monitor to AC power ranging from 100 volts AC to 240 volts AC The switch has two positions one for 100 120 ...

Page 27: ...allinckrodt the monitor may be attached to a GCX Poly mount bracket 2 Plug the female connector end of the power cord into the rear of the monitor Use only the hospital grade power cord provided by Mallinckrodt 3 Plug the male connector end of the power cord into a properly grounded AC outlet 4 Verify that the AC Power Indicator is lit If it is not ensure that the supply voltage selector switch ma...

Page 28: ...he SCP 10 or MC 10 directions for use 7 Plug the SCP 10 or MC 10 cabl e into the sensor port located on the front of the N 395 LANGUAGE SELECTION The languages available for display on the screen are English French Gennan Dutch Portuguese Spanish and Italian The N 395 is shipped with tlie factory default English language displayed To select tlie appropriate language after the unit is powered on pr...

Page 29: ... SCP I0 or MC 10 sensor cable Use of another sensor cable will have an adverse effect on performance Do not attach any cable that is intended for computer use to the sensor port Do not connect any device other than a Nekcsr approved sensor to the sensor connector WARNING Tissue damage can be caused by incorrect 1 application or duration of use of a SpOz sensor Inspect the sensor site periodically ...

Page 30: ...er Reusable nonsterile For use with the Dusa Y sensor Ear clip Reusable nonsterile Pedi CheckTM pediatric spot check Bioco npatibility testing has been conducted on Nellcor sensors in compliance with IS0 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation ai d Testing The sensors have passed the recoimneilded biocoinpatibility testing and are therefore in compliance with IS0 10993 1...

Page 31: ...or sensors and sensor cables Select an appropriate sensor apply it as directed and observe all warnings and cautions presented in the directions for use accoinpanying the sensor Clean and remove any substances such as nail polish from the application site Periodically check to ensure that the sensor remains properly positioned on the patient WARNING Tissue damage can be caused by incorrect applica...

Page 32: ...nsor it obtains measurements froin the nasal septa1anterior ethmoid artery an artery supplied by the internal carotid This sensor may obtain measurements when peripheral perfusion is relatively poor For low peripheral perhsioii consider using the Nellcor RS 10 sensor which is applied to the forehead or temple These are sites that may be spared during peripheral vasoconstriction Note The preceding ...

Page 33: ...isconnect from the monitor causing the monitor to drop on the patient IWARNING The N 395 is intended only as an adjunct in 1 patient assessment It must be used in conjunction with 1 Iclinical signs and symptoms WAmLNG Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions See the appropriate sect...

Page 34: ... contained in the Monitoring Mode paragraph of this section Ensure that the supply voltage selector switch on the rear panel matches the AC voltage at your location Power On Self Test POST WARNING Ensure that the speaker is clear of any obstruction Failure to do so could result in an inaudible alarm tone 1 Plug an appropriate Nellcor sensor firmly into the SCP 10 or MC 10 cable aizd lower the SCP ...

Page 35: ...the screen may be blank or the low priority alarm may not sound Refer to the Tvo bleshooting section for a list of correctable error messages 5 Upon successful completion ofthe POST the N 395 sounds a 1 second tone indicating that the monitor has passed the test WARNING If you do not hear the POST pass tone do not use the monitor 6 If a sensor is connected to the monitor and the patient the Pulse ...

Page 36: ...in the patient setting adult pediatric or neonatal appropriate for the patient being monitored The default power on setting from the factory is for adult and pediatric patients To determine which patient setting the N 395 is in press the LIMITS softkey If the monitor is in the adult pediatric setting the Adult Limits screen appears in the display To change the N 395 from the adult pediatric settin...

Page 37: ...e In Monitoring Mode Pleth View Figure 9 tlie N 395 displays SpO2 readings pulse rate readings and a pletli waveform In the Monitoring Mode Blip Magnified View Figure lo the Pulse Amplitude Indicator and a larger SpOz and pulse rate reading are displayed The pleth waveform is not displayed Instructions on how to select one of the two views by using the softkeys are given later in this section The ...

Page 38: ...itoring the N 395 enters Pulse Search During Pulse Search the monitor attempts to detect a pulse from which to take a measurement At initial Power Up Sensor Attached to Monitor Immediately after POST is completed and the N 395 displays its software version nuinber the monitor enters Pulse Search Mode and the Pulse Search Indicator lights If an attached sensor is not connected to a patient the disp...

Page 39: ...or or the monitor during monitoring a low priority alarm sounds values for SpOz and pulse rate are replaced with dashes and SENSOR DISCONNECTED is displayed on the screen Sensor Off If the sensor becomes disconnected froin the patient during monitoring a low priority alarm sounds values for SpOz and pulse rate are replaced with dashes and SENSOR OFF is displayed on the screen Automatic Shutdown Wh...

Page 40: ...ured patient parameter moves outside the set alann limits and if enabled the SatSeconds limit has been exceeded During a medium priority alarm the display flashes with the patient parameter that violated the limit Sp02 or Pulse Rate If the alarm is a SatSeconds alarm the SatSeconds indicator will be full 3 Low priority alarm Indicated by a slow low pitched pulsing tone A low priority alann sounds ...

Page 41: ... time before an audible alarm sounds The SatSeconds limit controls the time that the SpOz level may fall below the alarm limit before an audible alarm sounds The method of calculation is as follows The number of percentage points that the PO falls outside the alarm limit is multiplied by the iluinber of seconds that the SpOz level remains outside that limit This can be stated as an equation Poiilt...

Page 42: ...ecause 50 SatSeconds had been exceeded See arrow in Figure 5 0 1 2 3 4 5 6 7 8 9 1 0 1 1 SECONDS Figure 11 Alarm Response with Satseconds Saturation levels may fluctuate rather than remaining steady for a period of several seconds Often Sp02 levels may fluctuate above and below the alarm limit re entering the non alann range several times ...

Page 43: ... if the SatSeconds setting has not been reached Determining the SatSeconh The SatSeconds setting may be set at 10 25 50 or 100 SatSeconds or it inay be set to OFF The factory default setting is OFF The decision to utilize the SatSeconds feature and at what liinit or not to use it at all must be made based on the medical assessment of tlie patient s clinical signs and symptoms To set the SatSeconds...

Page 44: ...ay in the blip view Wlien the graph is completely filled indicating that the selected SatSeconds liinit has been reached an audible alarm sounds and the displayed SpOz value flashes As with traditional alarm management the audible alarm may be silenced by pressing the ALARM SILENCE button ADJUSTABLE SETTINGS The following adjustments can be made using the Adjust UpIDowii and ALARM SILENCE Buttons ...

Page 45: ...n 3 seconds and use the ADJUST UP or ADJUST DOWN Buttons to increase or decrease the value Possible values are 30 60 90 or 120 seconds or OFF The OFF selection is discussed later in this section The audible alarm silence duration begins when the ALARM SILENCE Button is pressed Subsequently if any alarm condition other than a low battery alarm occurs while the alarm is silenced the alann will not s...

Page 46: ...d The Alarm Silence Indicator flashes indicating that audible alarms have been disabled To re enable audible alanns the duration must be set to something other than OFF Visual indications of an alarm condition are not affected by disabling the audible alarms The ability to set the alarm silence duration to OFF can be enabled or disabled by qualified service personnel as described in the service ma...

Page 47: ...nds limits Language displayed on screen or data port Nurse call settings Analog output calibration voltage settings Display backlight odoff Menu items are selected by pressiilg and releasing the corresponding softkey directly below the item Refer to Table 2 Limits Meiiu to access menu items Note If after accessing a submenu no buttons are pressed for 10 seconds the display will time out and return...

Page 48: ...the instructions described in the N 395 service manual may change power on default alarm limits Alarm limits inay be changed froin their power on default values if necessary as described below Liinit changes made will remain in effect until changed again or until the N 395 is turned off Viewing Current Alarm Limits To view the current alarm limit values froin the main menu press the LIMITS softkey...

Page 49: ...to select the parameter that is to be changed Use the ADJUST UPIDOWN Buttons to change the settings The setting takes effect iinrnediately and remains in effect when the alarm setting menu is exited Table 2 Limits Menu LIMITS 1 SELECT 1 NEO ADULT ...

Page 50: ...Star UD and Use Table 3 Trend Menu TREND VIEW DUAL SP02 PULSE NEXT HlST VIEW NEXT DELETE DELETE TRENDS YES NO PRINT NEXT EXlT EXlT AMP NEXT ZOOM NEXT DELETE DELETE TRENDS YES NO PRINT NEXT EXlT EXIT ...

Page 51: ...Table 4 Setup Menu SETUP VIEW CLOCK NEXT EXIT PLETH BLIP SET EXlT SELECT EXlT SELECT EXlT LANG EXIT NEXT NCALL ANALOG EXIT NORM NORM EXlT 0 VOLT 1 VOLT STEP EXIT ...

Page 52: ...collectiilg the trend data I 96 _ BPM 79 The monitor stores up to 48 hours of trend data The amount of trend data displayed on the screen is determined using the ZOOM softkey Settings available are 40 seconds 15 or 30 minutes and 1 2 4 8 12 24 36 or 48 hours All data are displayed in a graph fonnat except the 40 second setting which is shown in tabular forinat SELECT NEO ADULT EXIT When the trends...

Page 53: ...rently displayed on the screen is indicated in the upper left corner The date and time indicate the location of the cursor on the top middle and right of the screen The cursor is moved right or left by using the ADJUST UPIDOWN Buttons Each press ofthe button causes the cursor to move a certain period of time depending on the trend scale as indicated in Table 5 Table 5 Trend Scale ...

Page 54: ... to the right of the screen an invalid tone would sound If only 3 hours of data was to the right of the screen the cursor would relocate to approximately 314 of the way to the right of the screen at the tiine period 14 58 05 Note The screen will return to the monitoring mode if an alarm sounds the ALARM SILENCE Button is pressed or a trend or histogram has been displayed for 5 iniiiutes with no bu...

Page 55: ...grain view is illustrated in Figure 17 Thehistogram graphically illustrates the percentage of time a given range of values has been measured The period of tiine covered is given in the upper left comer of tlie display Only points with data are included in the histogram For example in Figure 17 the histogram is for tlie last 12 hours During those 12 hours 68 of the Sp02 measurements were from 96 to...

Page 56: ...rsor as indicated by the time in the upper right hand comer of the screen remains the same A table is used to display 40 second trends The ZOOM softkey is not displayed for the histogram trend view 40 Second Trends n b l e The 40 second trends table is available by continuing to press the ZOOM softkey As indicated in Figure 19 the time indicated on trend graphs by the cursor is displayed in the up...

Page 57: ...g on the screen is highlighted and the UP ARROW button is pressed the screen shifts to display a newer column of readings Next The NEXT softkey provides access to the DELETE and PRINT softkeys Delete Pressing the DELETE softkey presents two options YES or NO YES deletes all trend information from the N 395 ineinoiy and the display NO returns the N 395 to the previous menu Print Note The protocol s...

Page 58: ...e displayed on the screen data port nurse call normally high or normally low setting data port analog calibration voltage Press the SETUP softkey once to display VIEW and CLOCK Then press NEXT to display COMM and LANG Press NEXT again to display NCALL and ANALOG The VIEW softkey allows selection of the screen to be displayed PLETH or BLIP magnified The pleth view displays tlie pleth waveform The B...

Page 59: ...rs GRAPH is used for graphical trend printouts when connected to a serial printer Select OXINET when connecting to an Oxinet 1 1central station network or Score software The Bedside Monitor Interface selections are contained in N 395 software versioils 1 7 and higher AGILENT for Agilent HP monitors SPACELBS for SpaceLab monitors MARQ for Marquette monitors and DATEX for Datex Ohmeda AS13 monitors ...

Page 60: ...ank screen on the Agilent monitor will indicate corrupt data The Agilent monitor will detect corrupt data in less than 100 milliseconds Wlieii the N 395 is in the Agilent mode of operation tlie interface baud rate must be set to 19 200bits per second Press tlie SETUP softkey then the NEXT softkey and then the COMM softkey to select BAUD Use the ADJUST UP or ADJUST IDOW buttons to select the correc...

Page 61: ...inmended for this interface Note Spare parts for the N 395 are listed on the Internet confirm the cable part number before orderiiig a cable The Internet address is http mallinckrodt corn respirator resp Serv Supp Apa rtweb inain PartAcceMenu litrnl Corrupt data will be indicated by a Communications Error displayed 011 the SpaceLabs monitor The SpaceLabs monitor will detect corrupt data in less th...

Page 62: ... cable has a DB 15 connector for the N 395 and the applicable connector for the Marquette Octanet TM interface module cable Nellcor cable part number 902254 is recoinmended for this interface Note Spare parts for the N 395 are listed on the Internet confirm the cable part nuinber before ordering a cable The Internet address is Corrupt data will be indicated by a Communications Error displayed on t...

Page 63: ...is http llmallinckrodt codrespiratoryiresp erv SupplApa rtweb inaii PartAcceMei u htinl Corrupt data will be indicated by a Commui ications Error displayed on the Datex monitor The Datex moilitor will detect compt data in less than 11 seconds When the N 395 is in the Datex mode of operation the interface baud rate must be set to 2 400 bits per second Pressing the SETUP softkey then the NEXT softke...

Page 64: ...e ANALOG softkey provides the capability to produce variable calibrating voltages to calibrate instruinents such as a chart recorder Refer to the Analog Outputs heading of Data Port Protocol for a more thorough explanation of these settings The LIGHT softkey turns the backlight on or off When the backlight is off pressing any softkey turns the backlight on Also the CONTRAST and ALARM SILENCE keys ...

Page 65: ...Table 6 Factory Default Settings Adult ...

Page 66: ...n exists The nurse call feature of the N 395 works in conjunction with the nurse call system of the institution when the monitor sounds an audible alarrn It is accessed through the data port pins 7 8 10 11 or 15 as indicated in Table 10 WAWING The nurse call feature is not functional whenever the monitor alarms are silenced The nurse call feature is available when the N 395 is operated 011 AC powe...

Page 67: ...y charge has been depleted first plug the monitor into an AC outlet to allow the battery to charge for a few minutes The monitor may then be powered on To charge a dead battery connect the monitor to AC power A full charge takes 14 hours while the monitor is turned off When all of the following conditions are present for 15 minutes the N 395 will automatically shut down Monitor is running on batte...

Page 68: ...ed back on It is recommended that qualified service personnel replace the internal battery every 24 months Caution If the N 395 is to be stored for a period of 3 months or longer notify service personnel to remove the battery from the monitor prior to storage Recharge the battery when it has not been charged for 2 or more months DISPOSAL OF DEVICE COMPONENTS Caution Follow local governing ordinanc...

Page 69: ...nctional hemoglobins defibrillation Ambient environmental conditions and sensor application errors which can affect pulse oximetry readings are discussed in the Sensors and Accessories section of this manual and in the sensor directions for use The effects of electromagnetic interference on oximetry readings are discussed in the Troubleshooting and Maintenance section of this manual ...

Page 70: ...ould be removed only by qualified service personnel There are no user serviceable parts inside Error Codes When the N 395 detects an error condition it may display the letters EEE followed by an error code When an error code other than the ones listed in Table 8 is displayed turn the instrument off and back on again If the error code reappears record it and notify service personnel Error messages ...

Page 71: ...e monitor off and let it charge for approximately 10 minutes and then reattempt to turn the unit on If the error code is still present turn the unit off and let it continue to charge If the monitor has been charged for 30 minutes and the error code is still present notify service personnel The current power on default settings have been lost and returned to factory defaults Qualified service perso...

Page 72: ...larm silence duration power on default to OFF The power on default cannot be set to OFF INVALID Sp02 LIMIT An attempt has been made to set either the upper or lower alarm limit power on default below 80 The power on default cannot be set below 80 Suggested Corrective Actions If you experience a problem while using the N 395 and are unable to correct it contact qualified service personnel or your l...

Page 73: ...quipment on the same AC circuit 4 The Pulse Search Indicator is lit for more than 10 seconds before any measurements are taken Check the sensor directions for use to determine if an appropriate sensor is being used and if it is applied properly Check sensor and sensor cable connections Test the sensor on someone else Try another sensor or sensor cable Perfusion may be too low for the N 395 to trac...

Page 74: ... of sensor Prolonged patient motion may be preventing the N 395 from tracking the pulse Verify that the sensor is securely applied and replace it if necessary Change the sensor site Use a type of sensor that tolerates more patient movement for example an adhesive sensor The sensor may be too tight there may be excessive ambient light or the sensor may be on an extremity with a blood pressure cuff ...

Page 75: ...395 is not 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 not seein to operate correctly Erratic readings cessation of operation or other incorrect functioning inay evidence disruption If this occurs the site of use should be surveyed to determine the source of this ...

Page 76: ...nitor display each time the monitor successfully completes the power on self test Write the number down and have it available whenever requesting technical assistance RETURNING THE N 395 Contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative for shipping instructions including a Returned Goods Authorization RGA number Unless otherwise instructed by Mallinckrod...

Page 77: ... service personnel should perforin the procedure in the Performance VeriJicationsection of the service manual Cleaning WARNING Do not spray pour or spill any Liquid on the N 395 its accessories connectors switches or openings in the chassis For surface cleaning and disinfecting follow your institution s procedures or The N 395 may be s trface cleaned by using a soft cloth dainpened with either a c...

Page 78: ...or minus X digits oxygen saturation percentage points between saturation of 70 and 100 This variation equals plus or minils one standard deviation I SD which encompasses 68 of the population All accuracy specifications are based on testing the subject monitor on healthy adult volunteers in induced hypoxia studies across the specified range Adult accuracy is detennined with Oxisensor 11 D 25 sensor...

Page 79: ... the following conditions no alanns and no analog or serial output devices attached A coinpletely discharged battery can be fully recharged in approximately 14 hours while unit is turned off or 18hours while tunled on Chargeldischarge cycles at least 400 Sensor The wavelength range of the light emitted is within the range of 250 nm to 1 000 nm with the energy not exceeding 10 rnw Pulse Rate accura...

Page 80: ...0 C 4 F to 140 F AltitudelBaroinetric 390 in to 4 572 m Pressure 1280 ft to 15 000ft 106kPa to 50 kPa 31 3 in Hg to 14 in Hg Relative Humidity 15 95 noncondeiising over temperature range of 20 C to 60 C 4 F to 140 F Operation Temperature 5 C to 40 C 41 F to 104 F Altitude Barsmetric 390 m to 3 658 in Pressure 1280 ft to 12 000ft 106kPa to 70 kPa 31 3 in Hg to 20 6 in Hg Relative Humidity 15 95 noi...

Page 81: ...601 1 CSA 601 1 UL 2601 Classification 1 Type of Protection Class 1 on AC power Internally powered on battery power Degree of Protection Type BF Applied part Enclosure Degree of IPX1 Ingress Protection from SolidsiLiquids Mode of Operation Coiitinuous EM1 Compatibility IEC 60601 1 1 ...

Page 82: ... by experienced N 395 users First time users of the monitor should read the entire Operator s Manual before use To turn the monitor on or off press Table 9 contains the procedures necessary to adjust or view the basic N 395 settings In general press EXIT to return to the main menu Table 9 Settings Adjustments ...

Page 83: ...m Voluine Baud Rate Action Press and hold for less than 3 seconds then Press Press and hold for more than 3 seconds while continuing to hold Press Press Press Press Press To select the desired baud rate Press Button or or EXIT a r s c 3 g g gg j fg cb 3 y2t t t a k Zb a ...

Page 84: ...Table 9 Settings Adjustments To select ACILENT MARQ or DATEX ...

Page 85: ...Table 9 Settings Adjustments ...

Page 86: ...Table 9 Settings Adjustments Button SELECT r i id to select SatSeconds or EXIT To Adjust SatSeconds Action Press Press Press Press ...

Page 87: ...Table 9 Settings Adjustments Press to return to I I ...

Page 88: ... by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of artevial hemoglobin the monitor uses the pulsatile nature of arterial flow Duriiig systole a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The monitor bases its Sp02 ineasurements on...

Page 89: ...einoglobin or methemoglobin In contrast hernoximeters such as the IL482 report fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin including measured dysfunctioilal hemoglobins To compare functioilal saturation measureineizts to those from an instrument that measures fractional saturation fractional measurements must be converted as follows fractional s...

Page 90: ...Figure 21 Oxyhemoglobin Dissociation Curve ...

Page 91: ...section Ally printer or PC coniiected to the monitor s data port must be certified according to IEC Standard 950 All combinations of equipment must be in compliaiice with IEC Standard 601 1 1 systems requirements Anyolie who coiinects a printer or PC to the data output port configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of syste...

Page 92: ...alent The shield must have a 360 degree connection to the metal shell on the N 395 s DB 15 coilnector and to the connector on the PC or serial printer Do not create sharp bends in the cable as this may tear or break the shielding The pinouts as illustrated in Figure 22 for the data port are listed in Table 10 Table 40 Data Port Pinouts GND is ground TxD represents the Transmit Data line and RxD is...

Page 93: ...re the differential receive pair No hardware flow control is used However in the ASCII mode XONIXOFF flow control is supported BAUD RATE Pressing the SETUP softkey and then the COMM softkey can change the baud rate Use the ADJUST UPIDOWN Buttons to select a baud rate of 2400 9600 or 19200 depending on the capabilities of the attached equipment SETTING DATA POR bPROT0COL The available data port pro...

Page 94: ...o not use the CLINICAL setting unless instructed to do so by Mallinckrodt s Technical Services personnel REAL TIME DISPLAY FORMAT While the N 395 data port protocol setting is set to ASCII refer to Start Up and Use section real time data is continuously sent to the data port on the back of the N 395 Patient data can be obtained through the data port by doiinecting it to an attached PC or serial pr...

Page 95: ...95 1 VERSION TIME 12 NOV 99 14 00 05 12 NOV 99 14 00 07 12 NOV 99 14 00 09 12 NOV 99 14 00 11 12 NOV 99 14 00 13 12 NOV 9914 00 15 12 NOV 99 14 00 17 12 NOV 99 14 OO 19 12 NOV 99 14 00 21 12 NOV 9914 00 23 12 NOV 99 14 00 25 12 NOV 99 14 00 27 12 NOV 99 14 00 29 12 NOV 99 14 00 31 12 NOV 99 14 00 33 12 NOV 99 14 00 35 12 NOV 99 14 00 37 12 NOV 99 14 00 39 12 NOV 99 14 00 41 12 NOV 99 14 00 43 12 N...

Page 96: ...iced and receives a software upgrade Alarm Limits N 395 VERSION 2 0 0 0 CRC XXXX Sp02 Limit 70 100 PR Limit 60 16OBPM TIME SpQ2 BPW PA Status The last data field in the top line indicates the high and the low alarm limits for Sp02 and for the pulse rate PR In the example above the low alarm liinit for Sp02 is 70 and the high alarm liinit is 100 Pulse Rate alarm limits are 60 and 160 bpin Column He...

Page 97: ...cated in the top row for pulse rate If no data for a parameter is available three dashes will be displayed PA is an indication of pulse amplitude The number can range from 0 to 254 There are no alarm parameters for this value It can be used for trending infoilnation as an indication of a change in pulse volume relative pulse strength or circulation Operating Status The Status colu nn indicates ala...

Page 98: ...ection of the display or printout TREND DATA PRINTOUT ASCII MODE The fornat of data displayed when a trend printout Figure 24 is requested is similar to that of the real time data The only differences are that TREND is displayed in the top row instead of the GRC XXXX software verification number and there is no Status columa Readings are displayed in 4 second intervals The values on each row are a...

Page 99: ... 14 35 05 SF302 80 70 Figure 25 Trend Data Printout GRAPH MODE NURSE CALL WAWING The nurse call feature should not be used as the primary source of alarm notification The audible and visual alarms of the monitor used in conjunction with clinical signs and symptoms are the primary source for notifying medical personnel that an alarm condition exists The N 395 provides two different types of nurse c...

Page 100: ...tput between pins 11 and 10 will be 5 to 12 volts DC When the setting is normally low NORM 1 the readings are opposite as indicated in Table 12 These voltages are present only when the monitor is operating on AC power If the audible alann has been turned off or silenced the nurse call alarm is also silenced Table 12 Voltage Between Pins 10 and 11 Pins 7 and 15provide a solid state relay that close...

Page 101: ... example as the current value of SpO2 varies from 0 to loo the voltage froin pin 6 to ground pin 10 would vary from 0 to 1volt A voltage of 94 volts indicates a current SpO2 value of 94 The analog output calibration function can be accessed from the main menu by pressing SETUP NEXT NEXT ANALOG Selecting 0 VOLT or 1 VOLT causes that voltage to appear at pins 6 3 or 10 Selecting STEP9 causes the vol...

Page 102: ...ASCII MODE 51 Auto natic Shutdown 33 Basic Operation 28 Battery Operation 61 Biocoinpatibility Testing 24 Buttons Adjust Down 7 Adjust Up 7 Alarrn Silence 7 Contrast 7 Changing Alarin Liinits 43 Cleaning 72 CLOCK 52 Codes Error 65 COMM 53 Connecting the N 395 19 Connecting to the Data Port 87 Contrast 31 Coxrective Actions 67 Data Port Baud Rate 89 Connection To 87 Pin Layout 89 Pinouts 88 Data Po...

Page 103: ...te 8 Pulse Search 9 SatSeconds 9 Valid Button Press 9 Volu ne Setting Tone 10 Initial Power Up 32 Inspection 11 Intended Use 3 LANG 57 Language Selection 21 LIGHT 58 Liinits 42 Liinits Menu 43 Loss of pulse 25 Low Batte y Indicator 61 Low Peripheral Perfilsion 26 Maintenance 7 2 Marquette Communicatioi s 56 Men l Stluchire 4 1 Messages Disallowed on Batte y 67 Disallowed on Low Batte y 67 Invalid ...

Page 104: ... Alarin Management 35 Deterinining Setting 37 Display 38 Safety Net 37 Saturation Calculated 84 Fractional 84 Functional 84 Measured 84 Selecting a Sensor 23 Sensor Selection 23 Sensor Disconnected 33 Sensor Off 33 Sensors 23 Service 72 Settings Adult Pediatric 30 Ajustable 38 Alarin Silence Duration 39 Alarin Silence Reminder 40 ASarrn Voluine 39 Default 58 Disabling Audible Alartns 40 Neonatal 3...

Page 105: ...Fuse Replacement 6 u See Insti uctions 6 rype BF Equip nent 6 Sy nbopls Data Interface 6 Taking Measurelnents 33 Technical Assistance 71 Trend 46 Histograin 49 Unpacking 11 Verification Perfol nance 11 72 View 52 Trend 48 Viewing Current Alarm Limits 42 Voltage Selector Switch 19 View 48 ZOOM 50 Trend Data Printout ASCII Mode z 94 Trend Data Printout GRAPH Mode ZOOM 50 95 Trend Menu 4 4 ...

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Nellcor N-395, Operator'S Manual

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