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Nellcor N-200 Operating Manual

1. 3 Interface powerbase is connected to AC power but the N 2009BATT IN USE indicator stays on Check the N 200 interface powerbase connection The BATT IN USE indicator turns off to confirm correct connection Replace the power cord check the connections or try another AC outlet Check fuse Troubleshooting General Oximetry Subsystem Problems 4 PULSE SEARCH indicator is on SpO2and pulse rate not displayed Check the patient The patient may be experiencing shock hypotension severe vasoconstriction severe anemia hypothermia arterial occlusion proximal to the sensor or cardiac arrest The sensor may be improperly applied for example too tight or it may not be plugged in There may be excessive ambient light cover the sensor site with opaque material The sensor may be placed on an extremity with a blood pressure cuff arterial catheter or intravascular line Move the sensor to an alternate site that is not affected The patient s perfusion may be too low for the N 200 to detect an acceptable pulse Use C LOCK ECG synchronization test the N 200 on someone else try another sensor site or try another sensor see the NELLCOR Sensors section for suggestions The sensor may be damaged replace it The patient module may be damaged try another patient module The pulse amplitude indicator tracks a pulse but there is no oxygen saturation or pulse rate Check the patient 79 Troubleshoo
2. Switch Section Function 1 Adult neonatal alarm settings 2 3 4 5 RS 232 format 6 Not used 7 8 Baud rate select C 13 200 and C 20 200 Patient Modules Caution Use only an N 200 patient module Using an N 100 patient module may adversely affect oximeter performance Ae NEUCOR a 34 36 35 Figure 4 C 13 200 and C 20 200 Patient Modules 34 Self adhering strap 35 Sensor connector F or NELLCOR sensors 36 ECG connector For a Nellcor approved ECG cable 20 Setup C 13 200M Patient Module Figure 5 C 13 200M Patient Module 37 Sensor lock and connector F or NELLCOR sensors includes lock to hold sensor in place 21 NELLCOR SENSORS Selecting a NELLCOR Sensor Cleaning and Reuse Performance Considerations WARNING Use only NELLCORoxygen transducers sensors Other oxygen transducers may cause improper oximeter performance WARNING Before use carefully read the sensor directions for use SELECTING A NELLCOR SENSOR When selecting a sensor consider the patient s weight and activity the adequacy of perfusion the available sensor sites the need for sterility and the anticipated duration of monitoring For more information refer to Table 2 or your local Nellcor representative 23 NELLCOR Sensors Table 2 Selected NELLCOR Sensors Oxygen Transducer Model OXISENSOR Il o OXISENSOR N 25 sterile single use 1 20 D 20 D 25 L R 15 OXICLIQ sterile single
3. good pulses and minimizes the effect of random artifacts associated with motion and low perfusion Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LE Ds varies an oximeter must know the mean wavelength of the sensor s red LED to accurately measure SpO2 During manufacturing the mean wavelength of the red LED is encoded in a resistor in the sensor During monitoring the instrument s software reads this resistor and selects coefficients that are appropriate for the wavelength of that sensor s red LED these coefficients are then used to determine SpO2 This resistor is read when the monitor is turned on periodically thereafter and each time a new sensor is connected Additionally to compensate for differences in tissue thickness the intensity of the sensor s LEDs are adjusted automatically Functional versus Fractional Saturation This monitor measures functional saturation oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen It does not detect significant amounts of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin In contrast laboratory hemoximeters report fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin including measured dysfunctional hemoglobins To compare functional saturation measurements to those from an instrument that measures fra
4. Trend memory is disabled TROUBLESHOOTING GUIDE This section discusses potential difficulties and suggestions for resolving them If the difficulty persists contact qualified service personnel or your local Nellcor representative The service manual provides additional troubleshooting information which is for use by qualified service personnel This section is divided into three troubleshooting categories Items 1 through 3 describe general system problems Items 4 through 13 describe general oximetry subsystem problems Item 14 describes trend memory problems 77 Troubleshooting General System Problems 78 1 N 200 does not turn on Check the AC and N 200 interface powerbase connections for proper AC power supply Check battery operation If the battery is discharged connect the N 200 to the interface powerbase Plug the power cord into an outlet supplying the appropriate mains voltage The interface powerbase requires a minimum of 14hours to recharge the N 200 battery completely Check AC fuse 2 N 200 operates on AC power but not on battery The battery may be discharged To recharge the battery connect the N 200 to the interface powerbase Plug the power cord into an appropriate AC power outlet and confirm that the BATT IN USE indicator is off A minimum of 14 hours is required to recharge the battery completely The battery pack or battery charger circuit may be defective or the battery fuse may be open
5. 40 The following automatic markers appear on Think et trend graphs Occurrence Marker Alarm limit event User defined event Power turned off Pulse signal is lost Clock is reset Signal is acquired rOWuMmMr Whenever an A marker appears the trend graph ends anda new one begins If less than 5 minutes elapse no A marker is printed instead the period during which the power was off or the signal was lost is represented on the trend graph by missing data points Data is plotted using a fixed time scale on the horizontal axis The time and date of data acquisition are printed below that axis Each event is marked by a tick on the horizontal axis Identifiers for the events appear in up to four additional lines of text that are printed below the time and date lines Each identifier consists of a letter that indicates the type of event and its onset time for example L3 47 indicates an alarm limit event that began at 3 47 a m As many identifiers as possible are packed into these four lines of text with each identifier approximately aligned with its tick mark on the axis If events are very frequent and too closely spaced so that all four lines of text are filled some identifiers do not print however all events are still identified by tick marks If more than 60 events occurred during the period of time covered by the trend memory only the last 60 will be identified by type of event and time of occurrence The remaining event
6. Switch selectable 1200 2400 9600 and 19 200 Formats Full Conditional Full Computer Alternate Computer Conversation and Beat to Beat Fiber optic transmitter Baud rate 2400 Formats Compatible with N 9000 recorder interface N 7500 pulse oximetry network and N 7000 interface Analog Data Output 4 each 3 32 inch phone jacks Outputs SpO2 Pulse Rate Pulse Wave Output Input ECG wave out or ECG wave defib sync input Voltage 0 1 V or 0 10 V switch selectable Range Set SpO2 0 100 or SpO2 50 100 switch selectable Accuracy 20 mV at zero 0 5 of full scale referred to front panel display ENVIRONMENTAL CONDITIONS Temperature N 200 41 107 6 F 5 42 C operating 32 122 F 0 50 C storage 88 Specifications Sensor Within physiologic range 82 4 107 6 F 28 42 C for accurate measurement Humidity Any humidity temperature combination without condensation Altitude 0 10 000 ft 0O 3 048 m ELECTRICAL CHARACTERISTICS Protective Class Class I mains supplied unit using a protective ground Degree of Protection Type BF patient electrically isolated Voltage 100 VAC 10 to 120 VAC 10 50 60 Hz Power Consumption Maximum rating 25 VA Mains Fuse Rating 1x T0 5 A slow blow 250 V Leakage Current 50 uA maximum power line to ground 10 pA maximum patient connector to ground 10 pA maximum patient connector to power line 89 Specifications Battery Type Lead acid batt
7. directions for use all precautionary information and specifications The user must check that the equipment functions safely and see that it is in proper working condition before being used The N 200 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms Do not use NELLCOR pulse oximeters during magnetic resonance image MRI scanning Adverse reactions include potential burns to patients as a result of contact with attachments heated by the MRI RF pulse potential degradation of the MR image and potential reduced accuracy of oximeter measurements Always remove oximetry devices and attachments from the MR imaging environment before scanning a patient For preamplification requirements only an N 200 patient module should be used with the N 200 pulse oximeter Do not use any other patient module for example the N 100 patient module Safety Information Alarms Do not silence the audible alarm or decrease its volume if patient safety could be compromised Check the audible alarm silence duration before temporarily silencing the audible alarm Each time the monitor is used check alarm limits to ensure they are appropriate for the patient being monitored Electrical Electric shock hazard Cover to be removed only by qualified service personnel There are no user serviceable parts inside Note Do not connect to an electrical outlet controlled by a wall
8. safety could be compromised To adjust audio alarm volume press and hold both the HIGH SAT and LOW SAT buttons and turn the control knob clockwise to increase the volume or counterclockwise to decrease it Silencing the Audio Alarm Temporarily WARNING If the operator silences the audio alarm during a pulse search alarm then the audio alarm will not resume at the end of the alarm silence period even if the pulse search event is continuing If the alarm has been silenced the operator should continue to visually check whether a pulse is being displayed To silence the audio alarm for 60 seconds press the AUDIO ALARM OFF button once The AUDIO ALARM OFF indicator lights steadily to show that the audio alarm has been silenced temporarily After 60 seconds the alarm sounds again if the alarm state continues Adjusting the Temporary Silence Period To change the period during which the audio alarm is silenced temporarily press and hold the AUDIO ALARM OFF button and turn the control knob until the desired period appears in the OXYGEN SATURATION display Release the button This period can be set for any value between 30 and 120 seconds Guide to Operation Disabling the Audio Alarm WARNING In normal operation the AUDIO ALARM OFF button temporarily silences the alarm Although the audible alarm can be disabled as described do NOT disable it if patient safety could be compromised To disable the audio alarm pres
9. scale to zero voltage deflections Time when the signal is A 2 second zero voltage acquired output Time when the pulse signal A full scale to current value islost deflection Time when the N 200 is A full scale to current value turned off deflection The event output can be stopped at any time by again pressing the EVENT button To restart the output push the EVENT button again if fewer than 30 seconds have elapsed the output continues from the point at which it was stopped if more than 30 seconds have elapsed the output starts again at the beginning While the event output is stopped there is a zero voltage output signal Do not attempt to print event data on a NELLCOR N 9000 recorder interface Sending Trend and Event Data to ASCII Devices Trend and event data collected by the N 200 is available to ASCII devices through the SERIAL COMM connector See Connecting to Other Instruments section for more information on trend and event data and RS 232 formats To Stop an Ongoing Output of Trend or Event Memories press and hold both TREND and EVENT buttons End Prt appears while continuing to press and hold the buttons turn the control knob clockwise until Prt End flashes Release the buttons Prt End lights steadily and the output is canceled Guide to Operation To avoid canceling the output after starting to do so before releasing the buttons turn the control knob to the left until Prt appears To Erase the Stored Tr
10. switch because power to the monitor could be inadvertently turned off Sensors Before use carefully read the sensor Directions for Use Use only NELLCORoxygen transducers sensors Use of other oxygen transducers may cause improper oximeter performance Tissue damage can be caused by incorrect application or use of a sensor for example wrapping the sensor too tightly or applying supplemental tape Inspect the sensor site routinely to ensure skin integrity and correct positioning and adhesion of the sensor If skin integrity changes move the sensor to another site Inspect the sensor and cable for fraying cracking breakage or other damage If defects are noted do not use the sensor Do not immerse sensor completely in water solvents or cleaning solutions because the connector is not waterproof Do not sterilize by irradiation steam or ethylene oxide Safety Information Measurements Loss of pulse signal can occur for the following reasons The sensor is too tight There is excessive illumination such as from sunlight or a surgical or bilirubin lamp The sensor is placed on an extremity with a blood pressure cuff arterial catheter or intravascular line The patient is in shock has hypotension severe vasoconstriction or anemia hypothermia arterial occlusion proximal to the sensor or cardiac arrest Inaccurate measurements may be caused by Incorrect application or use of a sensor Signi
11. the N 200 software version press the HIGH SAT and AUDIO ALARM OFF buttons A two digit version number appears in the PULSE RATE display For example version 2 7 appears as 27 It may be necessary to turn the control knob until 0 appears in OXYGEN SATURATION display To determine the powerbase software version press the HIGH SAT and AUDIO ALARM OFF buttons again and turn the control knob to the left until Pb appears in the OXYGEN SATURATION display the version number appears in the PULSE RATE display TECHNICAL ASSISTANCE 72 For technical information or to order parts or a service manual contact Nellcor s Technical Services Department or your local Nellcor representative The service manual includes circuit diagrams and a spare parts list which may be required by qualified personnel when servicing the N 200 Maintenance RETURNING THE N 200 If it is necessary to return the monitor to Nellcor call Nellcor s Technical Services Department for shipping instructions To repack the N 200 disconnect the patient module and wrap each separately If necessary the powerbase may be disconnected from the monitor Each should be wrapped separately Pack them in the original shipping carton In case the original carton is not available use a suitable box with an appropriate amount of packing material It is not necessary to return sensors or power cords 73 TROUBLESHOOTING Status Messages Troubleshooting Guide STATUS MESSAGE
12. 16 CONTE ina a EE E E TAAN 16 Front Panel cccccceeeeeeeeeeeeeeeneeeeeeeeeeeeeeeteeeneenaneees 16 Interface Powerbase Rear Panel 18 Contents Rear Panel Switches c cccccceeeeeeeeeeeeeeeeneeeeeneeeees 20 C 13 200 and C 20 200 Patient Modules 0 20 C 13 200M Patient Module cccceeceeeeeeeeeeeneees 21 NELLCOR Sensors ccccccccccecceeeeeeee eects eeceeeseeeeseneeeeeaas 23 Selecting a NELLCOR Sensor 23 Cleaning and Reuse ccccceeeeeeeeeeeeeeeeeeeseneeesenaeesteaeeee 24 Performance Considerations cccceceeteeeeeeeeeeeeeteaes 25 Guide to Operation cccccccccceceeeeecee cette eeeeeeeteeeeteneeeseaes 27 Basic Operation cccccecececeseeeeeeeeeeeaeeeeseeeeseneeeteeeeeeeaees 27 Pulse Oximetry Subsystem Features 28 Pulse Tonen iann arene te ainda aaae T 28 Alarm Functions ccccceceeeeeeeeeeeeeenaeeeeeeeeeeeeeeeeee 29 Oximetry Operating Modes s 33 C LOCK ECG Synchronization 34 Trend and Event Memories eese 38 User Defined Events sssssessrsrsssrirrssrrrnrererrnnessrrnnnns 43 Limit EventS erin ae aniidae faves ines 44 Communications Formats 2 ccccccceeeeeeeeeeeeeeneeeeeee 49 Interface Powerbase eseeeseeeseeeeeeerereereisrrrerrsee 58 Battery Operation 0 cccccceceeseeeeeeeeeeeeeneeeeeeeeseneeeeeaes 59 Connecting to Other Instruments a 61 OE E E AE A E ET 61 RS 232 C
13. ARM OFF buttons UdE n appears with n representing the number of minutes that remain in the ongoing event 43 Guide to Operation Turn the control knob until the desired number of minutes appears Then release the buttons To end a user defined event prematurely press and hold the HIGH RATE and AUDIO ALARM OFF buttons and turn the control knob to the left until UdE OFF appears Then release the buttons Limit Events 44 Setting the Limits that Trigger an Event Limit Normally the established alarm limits determine when a limit event occurs that is data is stored in the event memory whenever the saturation or pulse rate falls outside the alarm limits To set event limits that differ from the alarm limits the N 200 must be operating on AC power Press and hold the applicable alarm button HIGH SAT LOW SAT HIGH RATE or LOW RATE and the rear panel EVENT button while continuing to press and hold the buttons turn the control knob until the desired setting appears in the display The saturation event limits may be set for any value from 20 to 100 and the pulse rate event limits may be set for any value from 20 to 250beats per minute To make an event limit equal to the alarm limit again while the N 200 is operating on AC power press and hold the applicable alarm button and the EVENT button and at the same time turn the control knob to the right until AL appears in the display When the N 200 is turned off and b
14. NELLCOR OPERATOR S MANUAL NELLCOR N 200 Pulse Oximeter To contact Nellcor s representative In the United States call 1 800 NELLCOR or 510 463 4000 outside of the United States call Nellcor s local representative Caution Federal law U S restricts this device to sale by or on the order of a physician 2003 Nellcor Incorporated All rights reserved 066515 0203 Tyco Healthcare Group LP Authorized Representative Nelicor Puritan Bennett Division Tyco Healthcare UK LTD 4280 Hacienda Drive 154 Fareham Road Pleasanton CA 94588 USA Gosport PO13 OAS U K Toll Free 1 800 NELLCOR To obtain information about a warranty if any for this product contact Nellcor Technical Services or your local Nellcor representative NELLCOR DURASENSOR DURA Y OXIBAND OXICLIQ OXISENSOR OXISENSOR II OXINET C LOCK and the Nellcor knob configuration are trademarks of Nellcor Incorporated Think et is a trademark of Hewlett Packard Company Covered by one or more of the following U S Patents and foreign equivalents 4 621 643 4 653 498 4 700 708 4 770 179 4 869 254 4 911 167 4 928 692 4 934 372 5 078 136 CONTENTS Figures Tables Safety Information 0 ccccccctc cette eeens 1 Wangs couen arn aA r A eee teas 1 General arae r n E 2 Aarne ieed sea T A 2 Electrical seie irea eave unt A aiie ieai 2 SENSON a a Oa a S 2 Measurements 2 ccccccceeceeeeeeeeeeeeeeennaeeeeeeeeeeeeeeeees 3
15. NTER The P 200 printer may be used to print the contents of the trend and event memories as well as to record ongoing saturation pulse rate pulse amplitude and monitor status To use the P 200 with the N 200 1 Set the N 200 oximeter DIP switches as follows Switches 2 4 5 and 8 up Switches 3 and 7 down Switches 1 and 6 either up or down On the bottom of the P 200 set the DIP switches as follows On the row of eight switches set 1 2 and 6 down all others are up On the row of six switches set 4 5 and 6 down all others are up Connect the printer to the N 200 using the interface cable provided with the P 200 printer Turn on the printer and verify proper operation see the P 200 operator s manual 69 MAINTENANCE Service Cleaning Battery Testing Determining Software Version Technical Assistance Returning the N 200 SERVICE WARNING For continued protection against fire replace fuses only with those of the same type and rating The N 200 requires no routine service other than periodic battery replacement and any performance testing mandated by the operator s institution The Troubleshooting section discusses potential difficulties their possible causes and suggestions for resolving them Complete service instructions including performance tests checks are contained in the NELLCOR N 200 service manual CLEANING Caution Do not immerse the N 200 in liquid or use caustic or abr
16. Operation section If a difficulty occurs refer to the Troubleshooting section If that does not resolve the difficulty contact qualified service personnel or your local Nellcor representative 15 Setup COMPONENTS Display Two three digit red alphanumeric displays for oxygen saturation and pulse rate Sixteen segment bar graph for pulse amplitude indicator Indicators for LOW BATT PULSE SEARCH HIGH SAT LOW SAT HIGH RATE and LOW RATE alarms ECG LOST and AUDIO ALARM OFF Annunciators for BATT IN USE and ECG IN USE Controls Control knob to adjust volume and set alarm limits and five buttons to select alarm limits and disable audio alarm Rear panel switches for adult neonatal alarm settings analog voltage output range 0 1 V or 0 10 V analog saturation output scale 0 100 or 50 100 RS 232 format baud rate rear panel buttons for printing trend and event data analog full scale output and analog zero output Front Panel HIGH SAT Low SAT NEULCOR PULSE OXIMETER BA on IN gow PULSE EN RATION SEARCH SATURATIO ECG ECG CN me SS he Q PULSE RATE BEATS PER MINUTE HIGH RATE Low RATE AUDIO ALARM OFF TUL 15 14 13 12 11 10 9 8 Figure 2 N 200 Front Panel 16 10 11 12 13 14 15 Setup ON STDBY switch BATT IN USE indicator LOW BA
17. OrMANCe e E E ET EN A E E 85 ECG inaina aeiia i a a ae 86 Environmental Conditions ccceesceeeeseeeeeeeeeeeeneeeeenees 87 Electrical Characteristics 0 ccccccceceeeseeeeeeeeeeeeeeeeeeeeee 88 Physical Characteristics cccccceeeeeseceeeeeseeeeeteeeeeeeeee 89 FIGURES 1 Oxyhemoglobin Dissociation Curve s 13 2 N 200 Front Panel ccceeeeeeeeeeeeneeeeeeeeeneeeeeeeeaeeeeeeeaae 16 3 Interface Powerbase Rear Panel 18 4 C 13 200 and C 20 200 Patient Modules eee 20 5 C 13 200M Patient Module ceceeeeeeeseeeeeeeeeeeteeeeeees 21 6 Standard Limb Lead Selection cceceeeeeceeeteeeeeeees 36 7 Sample ThinkJet Trend Graph c cceeeeeseeeeeeeeeeneeees 41 8 Sample ThinkJet Event Graph ssssesesessesssrrerrrrerreesresne 46 TABLES 1 Rear Panel Dip Switch c ec eeceeeeeeeeeeeeeeeeseeeeseneeeeeaes 20 2 Selected NELLCOR Sensors 24 3 Default Alarm Settings cccceseeeeeeeeeeeeeeeeeeeteneeeteneees 31 4 SERIAL COMM Connector Pin Assignments 62 5 Output Format Switch Settings ccceeeeeeeeeeeeeeeeneeees 63 6 Baud Rate Switch Settings 0 ceeeeeseeeseeeseteeeeneeeeaes 65 SAFETY INFORMATION Warnings WARNINGS General DANGER Explosion hazard Do not use in the presence of flammable anesthetics The N 200 is to be operated by qualified personnel only Before use carefully read this manual accessory
18. S This section lists status messages along with the actions that the operator should take If the recommended actions do not cause the message to disappear contact qualified service personnel or your local Nellcor representative The service manual describes additional suggested actions for use by qualified service personnel ALL clr Trend and event memory has been erased The N 200 erases and reinitializes the memories if data has been corrupted or were erased The memories can also be manually cleared and reinitialized In both cases the ALL clr appears No further action is necessary Note When ALL clr appears because the memory data was corrupted or erased a simultaneous 5 second alarm sounds Note If the N 200 erases the trend and event memory a message header appears on the trend graph indicating that the oldest portion of the memory was erased CLrtE Stored trend and event data has been erased by the operator 75 Troubleshooting 76 Err Pb The powerbase is not communicating with the N 200 Disconnect the powerbase from AC power turn the N 200 off and back on again and reconnect the powerbase to AC power If this does not solve the problem contact qualified service personnel Note Theinstrument will clear the Err Pb message if any front panel button is pushed while the N 200 displays Err Pb but rear panel buttons and connectors may not operate properly Errl Defective data memory Contact qualified s
19. SYMDOINS ea Ae eh iain Ades 5 Quick Guide to Operation 1 ccccccccccecceeeteeeseeteeeeeeetenees 7 Basic Operation cccccccecceeeeeeeeeneeeseeeeeeeaeeeseneeeeeneeeeennees 7 Alarm Function Sosnin neni aaia teien Maaari ianei 7 Check Alarm Limits cccccsseeeeesseseeeeesesneeeeeeseeas 7 Adjust Alarm Limits 0 0 eccceeeeneeeeeeeenneeeeeeenneeeeeeneeas 7 Adjust Alarm Volume ccceesseeeeeeeenneeeeeeeeneeeeeeeeeaes 8 Silence Alarm Temporarily cccccceeeeeeseeeeeeeteeees 8 Adjust Alarm Silence Period s e 8 Pulse Tone VOlUMG 2 ccceceeeeeeeeeeeeeeennneeeeeeeeeeeeeeteees 8 Featur S accenno shed ee a a 9 OVET EW eieaa a ea Ln oii in led he ee 9 Automatic Self Test and Startup ecececeeeeeeees 9 Oximeter Configurable Settings ccccceeeeeeeeee 10 Principles Of Operation ccccccccccccecceeeeeneeeteteeeteneeetennees 11 Operating Principles ccceceeeeeeeeeeeeeeeeeeeneeeeeeeeeeieeenas 11 C LOCK ECG Synchronization 11 Automatic Calibration 0 ccccccsccceesssssteeeeesesneeeeeesees 12 Functional versus Fractional Saturation 0008 12 Measured versus Calculated Saturation 00 13 SOlUP EE EE ei Sa Gi hee Ge ase 15 Unpacking and Inspection 00 2 cceeeeeeeeeeetneeeeeteeneeeeeee 15 TOSUN eaa aara E AE AATA FA 15 Component ieri niaii iiaae i oa i i ed EA 16 Display criin sinian R aena a En RENAA n AERE TAERAA
20. TIONS Check Alarm Limits Press the appropriate alarm button HIGH SAT LOW SAT HIGH RATE or LOW RATE When the button is pressed the selected limit will show in the display Adjust Alarm Limits Press the appropriate alarm button HIGH SAT LOW SAT HIGH RATE or LOW RATE and turn the control knob until the desired setting appears Quick Guide to Operation Adjust Alarm Volume Simultaneously press the LOW SAT and HIGH SAT buttons Turn the control knob until the desired setting appears in OXYGEN SATURATION display Pushing the LOW SAT and HIGH SAT buttons activates the audible alarm to indicate volume Silence Alarm Temporarily Press the AUDIO ALARM OFF button The ALARM OFF indicator lights steadily during the alarm off period Do not silence the alarm if patient safety could be compromised Adjust Alarm Silence Period Press and hold AUDIO ALARM OFF button and turn the control knob until the desired setting 30 120 seconds appears in the OXYGEN SATURATION display PULSE TONE VOLUME Turn the control knob to adjust the pulse tone volume FEATURES Overview OVERVIEW The NELLCOR N 200 pulse oximeter measures functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate The system consists of three components the N 200 pulse oximeter an interface powerbase and a patient module The N 200 monitors SpO2 and pulse rate continuously and noninvasively with measurements updated at each pulse beat The i
21. TT indicator Flashes when five or fewer minutes of battery power remain PULSE SEARCH indicator F lashes when the N 200 is attempting to locate the patient s pulse OXYGEN SATURATION display Control knob Changes instrument settings or limits HIGH SAT LOW SAT HIGH RATE LOW RATE indicators Flash during an alarm state HIGH SAT LOW SAT HIGH RATE LOW RATE buttons Display alarm limits AUDIO ALARM OFF button Temporarily silences audible alarms AUDIO ALARM OFF indicator Lights steadily when the audio alarm has been temporarily silenced flashes when the audio alarm has been disabled PULSE RATE display Pulse amplitude indicator Vertical column of light bars that qualitatively indicates pulse amplitude ECG IN USE indicator Flashes when the N 200 locates an ECG signal lights steadily when the N 200 locks onto the signal ECG LOST indicator Patient module connection socket 17 Setup Interface Powerbase Rear Panel 16 17181920 21 NELLCOR INCORPORATED zeho INTERFACE POWERBASE SERIAL NO on A WARNING Oe TL A neptace rust AS MARKED ii DATA SERIAL T T T si e i apr 33 3231 3029 28 27 26 PEEHI 25 24 23 Figure 3 Interface Powerbase Rear Panel 16 ZERO button Provides a zero volt signal on PULSE SAT and RATE analog out
22. ack on again the event limits are reset to the alarm limit values Printing Event Data Data in the event memory may be printed graphically on a Thinkj et printer with an RS 232 serial interface model 2225D or a strip chart recorder as described in this section To print the contents of the event memory the N 200 must be operating on AC power The N 200 continues to function as a monitor while the event data is being printed The data is retained in memory after printing unless they are erased as described at the end of this section Guide to Operation Using a Think et Printer Connect the Think et printer to the N 200 as described in the Connecting to Other Instruments section To print event data in graphic form set the RS 232 format switches to graphics mode or as described in the same section To print events in graphic form press the EVENT button on the back of the N 200 The events are printed when the button is released When event data is output on a Think et printer the earliest data is in the top left of the page The graph begins 30 seconds before the beginning of each event and an automatic marker identifies the type of event alarm limit L or user defined E Each marker consists of a tick mark on the horizontal axis along with a letter that indicates the type of event and the time of onset for example E 15 10 identifies a user defined event that began at 3 10 p m New scales are printed for each even
23. ailable 49 Guide to Operation 50 Full and Conditional Full Formats These formats are designed for ASCII printer or CRT display output There are two format variations chosen by switch section 2 see Table 1 e If switch section 2 is in the DOWN position Full format the once a minute RATE SAT PULSE line is displayed regardless of alarm conditions e If switch section 2 is in the UP position Conditional Full format MONITOR STATUS ALARM ACTIVE and LIMITS are displayed immediately upon any changein monitor status limit settings or alarms Note Once monitor status has been displayed because of a change in limits or because of an alarm the RATE SAT PULSE line returns to once a minute output In Full format the following lines appear once a minute HH MM SS MONITOR RATE nnn 02 SAT nnn PULSE AMPL FS nnn or HH MM SS MONITOR NO PULSE DATA HH MM SS is the time set on the N 200 s internal clock and F S is the pulse amplitude expressed as a percentage of full scale In Conditional Full format if alarm status monitor status or limits change one of the preceding lines appears again with the following message preceded by an asterisk to identify which variable has changed Guide to Operation MONITOR STATUS NORMAL or SEARCH SENSOR OFF AUDIO ALARM OFF and ECG IN USE or ECG NOT IN USE Note If the message ECG UNKNOWN appears instead of ECG IN USE or ECG NOT IN USE this indicates mismatched sof
24. asive cleaners To clean the N 200 s surfaces dampen a cloth with a commercial nonabrasive cleaner and wipe the top bottom and front surfaces lightly Do not spray or pour any liquid directly on the N 200 interface powerbase or their accessories Do not allow any liquid to come in contact with the power connector fuse holder or switches Do not allow any liquid to penetrate the connectors or openings in the chassis BATTERY TESTING The N 200 is equipped with sealed lead acid batteries Battery capacity decreases over time due to several factors such as temperature depth of discharge and number of charge discharge cycles 71 Maintenance Replacing the battery periodically ensures battery operation when needed A periodic battery check is also recommended The interval for this check is at the user s discretion Depending on how the monitor is used the user may wish to perform a battery check as often as every 6 months This check should also include inspecting the battery s physical condition Any batteries showing leakage or corrosion should be replaced Qualified service personne should check the battery following instructions given in the N 200 service manual Regardless of periodic test results Nellcor recommends battery replacement every 2 years Replacement batteries can be purchased through Nellcor s Technical Services Department or your local Nellcor representative DETERMINING SOFTWARE VERSION To determine
25. ave become dislodged from the ECG IN OUT connector on the rear panel of the N 200 Trend Memory Problems 14 Trend data is not available The N 200 may not be plugged into a functional outlet supplying mains power Data in the trend memory may have been erased The memory battery may be defective Contact qualified service personnel Try a different powerbase if one is available 84 SPECIFICATIONS Performance ECG Environmental Conditions Electrical Characteristics Physical Characteristics PERFORMANCE Range Saturation 0 100 Pulse Rate 20 250 bpm beats per minute 85 Specifications P 1 2 Accuracy and Motion Tolerance Saturation Without Motion Adults 70 to 100 2 digits Without Motion Neonate 70 to 100 3 digits With Motion Adults and Neonates 70 to 100 3 digits Low Perfusion 70 to 100 2 digits Pulse Rate Without Motion 20 to 250 bpm 3 digits With Motion normal physiologic range 55 125 bpm 5 digits Low Perfusion 20 to 250 bpm 3 digits i Applicability D 25 D 25L and N 25 sensors 2 Definition of Nellcor Standard Motion Tapping 1 2 cm amplitude at an aperiodic frequency between 1 4 Hz Rubbing 1 2 cm amplitude at an aperiodic frequency between 1 4 Hz Note aperiodic is a randomly changing frequency gt Adult specification is shown for D 25 and N 25 sensors with the N 200 Neonate specification shown for N 25 sensors wi
26. ccurred The host device must wait for a minimum of 30 seconds after sending the V stop sending command before sending another command 55 Guide to Operation 56 Data Packet Descriptions The following data packets may be received in trend or event data transmission For V W X and Z packets the first field n n has variable length E Packet lt STX gt E lt CRLF gt lt ETX gt This is the last record sent to indicate end of data in normal completion V Packet lt STX gt Vnnn lt CRLF gt lt ETX gt This is sent only if the N 200 stops before the requested data transmission is complete It indicates why the N 200 stopped nnn Reason for Stop 4 Timeout error 8 Data error 16 Timed out error 32 Communications lost 64 Data recall error 128 By operator request W Packet lt STX gt Wn nSnnnRnnn lt CRLF gt lt ETX gt These are the actual trend data points Data is sampled every second so each packet represents 5 seconds of saturation and pulse rate data Wn n Trend data point n n current index up to 4 digits Snnn Saturation Rnnn Pulse rate X Packet lt STX gt Xn nSnnnRnnnPnnn lt CRLF gt lt ETX gt These are the actual event data sampled every second Thereis no averaging so each packet represents 1 second of saturation pulse rate and pulse amplitude data Guide to Operation Xn n Event data point n n current index up to four digits Snnn Saturation Rnnn Puls
27. ct ECG capabilities conform to AAMI standards For optimal performance position the RA right arm and LA left arm electrodes below the lateral aspect of each clavicle Position the LL left leg electrode at the left costophrenic margin in the mid axillary line Attach the lead wires to the electrodes and connect the lead wire pins tothe ECG cable observing correct limb connections Finally plug the ECG cable into the patient module s direct ECG connection socket This is a standard three lead ECG connector a Nellcor approved three lead ECG cable should be used 35 Guide to Operation 36 II HI LL Figure 6 Standard Limb Lead Selection High Level ECG Input To use the signal from a bedside ECG monitor connec either the defibrillator sync pulse output or the analog E CG waveform output high level output from the external ECG monitor to the interface powerbase ECG IN OUT connector Use only a Nellcor supplied or Nellcor approved ECG patch cord and connect the patch cord as described in its Directions for Use It is important to select the appropriate patch cord for each ECG monitor If questions arise contact qualified service personnel or your local Nell cor representative Refer to the operator s manual for the ECG monitor before attempting any connection When using the signal from an ECG monitor the signal must be connected to the interface powerbase and it must be operating on AC power Testing ECG Patch Cor
28. ctional saturation fractional measurements must be converted as follows fractional saturation functional saturation x1 100 carboxyhemoglobin methemoglobin 12 Principles of Operation Measured versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen PO2 the calculated value may differ from the SpO2 measurement of a pulse oximeter This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO2 and saturation Figure 1 pH temperature the partial pressure of carbon dioxide PCO2 2 3 DPG and fetal hemoglobin 100 ee Pf atthe ene Q E pH 2 50o t Temperature t PCO2 gt t 2 3 DPG T 0 T T T 50 100 PO2 mmHg Figure 1 Oxyhemoglobin Dissociation Curve 13 SETUP Unpacking and Inspection Testing Components UNPACKING AND INSPECTION Notify the carrier immediately if the N 200 shipping carton is damaged Carefully unpack the instrument and its accessories Confirm that the following items are included 1 N 200 pulse oximeter 1 __interface powerbase 1 hospital grade power cord 1 patient module 1 operator s manual 1 guide to operations Inspect each component If any component is missing or damaged contact Nellcor s Customer Service Department or your local Nellcor representative TESTING Verify all functions as described in the Guide to
29. ctor Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial hemoglobin the monitor uses the pulsatile nature of arterial flow During 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 SpO2 measurements on the difference between maximum and minimum absorption that is measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating the effects of nonpulsatile absorbers such as tissue bone and venous blood C LOCK ECG Synchronization C LOCK ECG synchronization read through motion to provide valid readings for many types of motion During C LOCK signal processing the monitor requires two signals that reflect cardiac activity the electrical pulse from the ECG and the optical pulse from the oximetry sensor 11 Principles of Operation The delay between the electrical ECG pulse and the optical pulse at the sensor site is relatively stable for a given patient and sensor site C LOCK processing takes advantage of this temporal relationship using the QRS complex as a reference point for identifying the oximetry pulse and for timing SpO2 measurements This enhances
30. d WARNING Before use confirm that the ECG patch cord connector is compatible with the ECG monitor and test the patch cord as described in the patch cord Directions for Use If the patch cord is fabricated at the user institution also perform a continuity test before clinical use Guide to Operation For each ECG monitor to be used with the N 200 test instrument and patch cord function on someone as follows 1 Position conventional disposable ECG electrodes in the configuration that will be used clinically The ECG output signal must have the characteristics previously described Use the ECG patch cord to connect the appropriate output of the ECG monitor ECG out or defibrillator sync to the interface powerbase ECG IN OUT connector Turn on both instruments Verify that a normal tracing is displayed on the ECG monitor that the pulse rate displayed by the N 200 is accurate and that the ECG IN USE indicator lights steadily Apply a NELLCOR sensor to that same person following the Directions for Use Connect the sensor to the NELLCOR patient module and verify that a saturation value is displayed by the N 200 and that the ECG IN USE indicator lights steadily Test all instrument functions under both normal and alarm conditions for example ECG leads off to ensure appropriate operation before clinical use see the operator s and service manuals of the N 200 and the external ECG monitor Should problems arise dur
31. e rate Pnnn Pulse amplitude Y Packet lt STX gt YnDnnnnnnnn lt CRLF gt lt ETX gt This is the time marker description indicating the type of marker and the time it occurred Yn Event Type User defined event Alarm limit exceeded Patient signal lost Unused Time mark on hour for trend on min for event Power turned off Patient signal acquired Clock reset NOUBWNEF OO Dnnnnnnnn Time Date format mmhhDDMM Z Packet lt STX gt Zn nSnnnsnnanRnannrnnn lt CRLF gt lt ETX gt This defines the number of data packets and the maximum and minimum values in the following trend or event information This can be used for scaling purposes Zn n Starting scale n n number of data points or number of data packets minus 1 the last W or X packet is a throwaway Snnn MAX saturation snnn MIN saturation Rnnn MAX pulse rate rnnn MIN pulse rate 57 Guide to Operation No Real Time Output Graphics Format In this mode there is no output of real time saturation and pulse rate data Trend and event data can be transmitted to an output device in low resolution graphic format if one is connected The sign on message from the powerbase is printed when AC power is first connected Graphics Modes I and II In these modes the sign on message is Suppressed and there is no output of real time saturation and pulse rate data Trend and event data is transmitted to an output device if oneis connected Data can be ou
32. e surgical site as possible The sensor may be damp or may have been reused too often Replace it If using a sensor extension cable remove it and connect the sensor directly to the patient module 8 ECG LOST is displayed Check the patient If the ECG signal is provided through the patient module There may bea loose unplugged or defective ECG electrode or electrode cable Check the connections If the problem persists replace the electrodes and or ECG cables If ECG is provided through the patient module the module may be defective Try another patient module R wave amplitude may be insufficient Check the ECG electrode position to verify proper lead configuration Select LEAD SELECT limb lead with greatest R wave amplitude ECG signal provided via the rear panel connector is inadequate There may bea loose unplugged or defective ECG cable Check the connections If the problem persists replace the electrodes and or ECG cables 81 Troubleshooting 82 10 Theinput signal from the ECG monitor may be incorrect Use high level 0 5 to 15 V ECG analog output or defibrillator sync pulse wave AC power tothe N 200 may have been interrupted An ESU may beinterfering Refer to discussion in Item 7 When ECG is connected pulse rate displays but not saturation e Check the patient e The sensor may be improperly applied or connected check it The patient s perfu
33. end and Event Data press and hold the HIGH SAT and HIGH RATE buttons CLr t E appears in the display at the same time turn the control knob to the right until ALL clr appears in the display Then release the buttons The contents of both memories will be erased To preserve the data after starting to erase the memories while still pressing and holding the buttons turn the control knob to the left until not clr appears Then release the buttons To Disable Trend and Event Memories simultaneously press the HIGH SAT HIGH RATE and AUDIO ALARM OFF buttons and turn the control knob until a flashingt E dis appears If the memories are disabled reactivate them by pressing and holding the buttons and turning the control knob until a flashing t E On appears When the memories are disabled the operator can still trigger a user defined event as previously described When the N 200 is turned off and back on again the memories are made active again Communications Formats Of the nine RS 232 formats used with the N 200 six produce ASCII trend and event data output Full Conditional Full Computer Alternate Computer Conversation and Beat to Beat Conversation format is recommended for accessing trend and event data WARNING In Full Computer or Beat to B eat Formats real time data output is inhibited while the trend and event data are being transferred to the ASCII device The current monitored data for this period is not av
34. ervice personnel Err2 Defective program memory Contact qualified service personnel Err3 WARNING Continue to use the N 200 only in an urgent situation and only if the defective segment or segments have been identified If a defective segment cannot be identified do not continue to use the N 200 Defective display or indicator or possibly a circuit malfunction Contact qualified service personnel Note The N 200 may operate if any front panel button is pressed while Err 3 is showing However if any numeric display segment or indicator is missing the display or warning indicators may be incorrect Err4 The N 200 lost power without going through the normal shutdown procedure Turn the ON STDBY switch to STDBY and back to ON Contact qualified service personnel if error persists Troubleshooting Err5 Hardware error Contact qualified service personnel Note The N 200 may operate if any button is pressed while Err 5 is displayed Err6 Battery backed memory contents have been lost and the trend memory was erased and reinitialized The trend memory operates normally as long as the N 200 is turned on but when the ON STDBY switch is set toSTDBY the trend memory will be erased Contact qualified service personnel Note This message may also appear briefly when the N 200 is first turned on after software has been replaced with a different version No action is required tE On Trend memory is active tE diS
35. ery pack 2 4 AH Battery Life 90 minutes typical on new fully charged battery age and usage affect battery performance Recharge Period 14 hours minimum 80 charge after 8 hours Charger Type Float voltage 450 mA current limit PHYSICAL CHARACTERISTICS Dimensions N 200 only 2 5 high x 10 wide x 7 in deep 64 x 254 x 178 mm With powerbase 6 5 high x 10 wide x 10 in deep 165 x 254 x 254 mm Weight N 200 only 5 lb 2 3 kg With powerbase 8 lb 8 7 kg Patient Module 90 Cable length 13 ft 4 m cable C 13 200 C 13 200M 20 ft 6 m cable C 20 200 Connector Lemo B series mates with 12 pin connector on N 200 front panel
36. es are used to set the communication port format as shown in Table 5 The serial communication format of the N 200 is eight data bits no parity bit and one stop bit Table 5 Output Format Switch Settings Format Name Switch Sections Description 2 3 4 Conversation Full Conditional Full Computer Alternate Computer Beat to Beat Up or down This feature is only available for monitor and powerbase software Request for x Down parameter Full readable Down Down strings for CRT or printer Full readable Up Down strings for CRT or printer only in alarm condition or when status changes Single identifier Down Down character plus values normal format Variation of Up Down computer format above for Spacelabs 90600 series ECG monitors Outputs rate and i Up saturation once per beat versions 2 5 0 and higher Up Down Down Up Up Down Up Up Up Down Down Up 63 Connecting to Other Instruments Table 5 Output Format Switch Settings continued Format Switch Sections Name Description 2 3 4 5 N 9000 Used with Down Down Down Recorder and NELLCOR N 7000 N 9000 and Interface N 7000 recorder interface units Graphics Suppresses sign Up Up Down Mode on message and real time data output trend is output in low resolution graphic form if a printer iS connected Event data is automatically printed in high res
37. ficant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin Significant levels of indocyanine green methylene blue or other intravascular dyes Exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight Exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material Excessive patient movement Venous pulsations High frequency electrosurgical interference and defibrillators Placement of the sensor on an extremity that has a blood pressure cuff arterial catheter or intravascular line SYMBOLS UN Attention Refer to Manual Fuse Replacement Symbol AN Caution Shock Hazard QUICK GUIDE TO OPERATION Basic Operation Alarm Functions Pulse Tone Volume BASIC OPERATION 1 Select the appropriate NELLCOR sensor and apply it to the patient following sensor directions for use Connect the sensor to the patient module 2 Plug the N 200 into a properly grounded AC outlet using a hospital grade power cord Alternatively operate the N 200 on its internal battery Turn on the system switch the ON STDBY switch tothe ON position 3 For C LOCK ECG synchronization connect an appropriate ECG signal source to the N 200 4 Check alarm limits If necessary adjust them to suit the patient s needs ALARM FUNC
38. hanging Operating Mode Press and hold the HIGH RATE and LOW RATE buttons Turn the control knob until the desired value appears in the PULSE RATE display C LOCK ECG Synchronization 34 WARNING An ECG monitor output that is delayed by more than 40 milliseconds from the actual QRS complex may prevent the N 200 from calculating and displaying saturation or may display inaccurate measurements If this condition is observed disconnect the patch cord and use the N 200 without C LOCK ECG synchroniza tion or substitute a different ECG monitor or connect the patient ECG leads directly to the connector on the NELLCOR C 13 200 or C 20 200 patient module To provide reliable saturation measurements in a high motion environment or when a patient has poor perfusion the N 200 can use an ECG R wave signal to identify the pulse and synchronize the saturation measurements Connecting the ECG Signal The N 200 monitor can receive an ECG signal either directly from the patient by a conventional three lead ECG cable connected to a patient module connection or from a bedside ECG monitor by the proper patch cord For proper operation only a Nellcor approved three lead ECG cable from the monitored patient should be connected to a C 13 200 or C 20 200 patient module ECG connector Do not connect any other signal such as the output from an ECG monitor to this connector Signal Requirements For signals from a bedside ECG monitor the peak of
39. hat enhances oximetry signal processing during patient movement or for patients with low perfusion e Three oximetry operating modes that change measurement averaging time to suit varied clinical applications e Oximetry trend memory with up to 12 hour SpO2 and pulse rate trend data storage e Oximetry and pulse rate event memory with 1 hour event data storage Data storage of event memory markers includes alarm limit defined events and user defined events e Analog and digital output of saturation pulse rate and pulse waveform data When an ECG signal is provided to the patient module three lead ECG connector the N 200 provides an analog output of the ECG waveform WARNING Do not use the ECG analog output as a trigger for synchronous defibrillation 10 PRINCIPLES OF OPERATION Operating Principles OPERATING PRINCIPLES Pulse oximetry is based on two principles that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light that is spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse that is plethysmography A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low power light emitting diodes LEDs in the oximetry sensor serve as light sources a photodiode serves as the photodete
40. hat is established whenever the monitor and powerbase are connected and AC power is supplied Saturation pulse rate pulse waveform and monitor and alarm status data are transmitted from the monitor to the powerbase where they are translated into analog or digital outputs ECG input as well as status requests are transmitted from the powerbase to the monitor Disconnecting the Powerbase from the Monitor The monitor can be disconnected from the powerbase for portable use To doso place the instrument on a flat stable surface and firmly push the latches on each side of the monitor which allows the units to be separated The analog digital and fiber optic outputs and ECG defib sync inputs from the external monitor are not available when the powerbase is detached from the monitor or when AC power is not supplied To reconnect the units place them on a flat stable surface and position them so that the groove on the powerbase is aligned with the rib on the monitor Push the powerbase straight in until the latches on the monitor engage Battery Operation If AC power is lost or the interface powerbase is disconnected the N 200 operates on its internal battery typically 90 minutes for a new fully charged battery When the battery level is too low to power the instrument reliably an internal switch turns off the N 200 automatically The battery recharges whenever the instrument is plugged into AC power A minimum of 14 hours is req
41. he EVENT button The event is then printed Also pressing the EVENT button for at least 3 seconds and then turning the control knob until the identifier for the desired event appears causes that event to be printed The identifiers for events are the same as those printed on the Think et output a letter that indicates the type of event and the hour and minute at which the event started Using an Analog Strip Chart Recorder Connect the strip chart recorder to the N 200 as described in the Connecting to Other Instruments section Calibrate the recorder adjust the settings as necessary and confirm proper operation If the N 200 is also connected to a graphics printer that printer must be turned off Otherwise the event data will be printed by the graphics printer rather than the strip chart recorder To Print the Event Memory press the EVENT button on the back of the N 200 Approximately 10 minutes of data is printed each minute Events are separated by a zero voltage output on each channel The earliest event and earliest data are presented first The following automatic markers appear on the event graphs printed by an analog strip chart recorder 47 Guide to Operation 48 Occurrence Marker Beginning of the event output A 1 second zero voltage which is 30 seconds before output followed by one full the beginning of the event scale deflection and another 1 second zero voltage output Beginning of the event Two full
42. he corresponding pin assignments for a 25 pin RS 232 connector 61 Connecting to Other Instruments 62 Table 4 SERIAL COMM Connector Pin Assignments Output Output Connector Signal Device Device Pin Direction Pin Signal 1 not used none none none 2 Rx data e 2 Tx data 3 Tx data gt 3 Rx data 4 DTR gt 6 DSR 5 Signal Ground lt e 7 Signal Ground 6 DSR lt 4 RTS 7 RTS gt 5 CTS 8 CTS lt 20 DTR 9 Alarm Out gt 25 see warning WARNING Pin 9 only gives notice of alarm limit violations It will not alert a remote system of signal loss or sensor disconnection Do not use this Pin to activate a remote alarm system Note Thelogic level output of Pin 9 is not intended to activate a remote alarm system Its use is intended to allow remote sensing of alarm limit events only Pin 9 output is less than 0 3 V when noalarm limit is violated and greater than 4 0 V when an alarm limit violation exists This pin should be connected to a high impedance circuit greater than 1 megohm and protected against transient voltages Pin 6 DSR must be held high by the connected device if trend and event data are to be output in ASCII format to that device Pin 8 CTS may be used to control transmission data When held high positive voltage data transmission takes place When low negative voltage data transmission is suspended temporarily Connecting to Other Instruments Communications Formats The RS 232 format switch
43. incorrect sensor application or use significant levels of dysfunctional hemoglobins intravascular dyes bright light excessive patient movement venous pulsations electrosurgical interference and placement of a sensor on an extremity that has a blood pressure cuff arterial catheter or intravascular line Observe all instructions warnings and cautions in this manual and in the sensor Directions for Use 12 Oxygen saturation does not correlate with laboratory hemoximeter Fractional measurements may not have been converted to functional measurements before the comparison was made The N 200 as well as other two wavelength oximeters measure functional saturation Multi wavelength oximeters such as the Instrumentation Laboratory282 CO Oximeter and Corning CO oximeters measure fractional saturation Fractional measurements must be converted to functional measurements for comparison Refer to the equation for this conversion in the Principles of Operation section Close correlation requires simultaneous blood sampling and pulse oximeter measurements from the same arterial supply 83 Troubleshooting 13 OXYGEN SATURATION display is erratic ECG LOST indicator is flashing The ECG electrodes may be displaced dislodged or disconnected from the ECG cable The ECG cable may be disconnected from the patient module or powerbase interface connector If the ECG signal is coming from an ECG monitor the input cable may h
44. ing any test procedure first check all connections If that does not resolve the problem contact qualified service personnel or your local Nellcor representative Operation with an ECG Signal TheECG IN USE indicator flashes when the N 200 locates an ECG signal When the N 200 locks on to an adequate signal the ECG IN USE indicator lights steadily The ECG R waveis then being used to identify the pulse and synchronize saturation measurements 37 Guide to Operation Trend and Event Memories 38 Determining Whether Memories Are Enabled To determine if trend or event memories are enabled press HIGH SAT HIGH RATE and AUDIO ALARM OFF buttons simultaneously If trend and event memories are disabled t E dis appears in OXYGEN SATURATION and PULSE RATE displays If trend and event memories are enabled t E on appears in the displays Setting the Clock Before storing data in the memories initially set the internal clock as described below 1 Press and hold the LOW SAT and HIGH RATE buttons simultaneously The flashing numbers in the OXYGEN SATURATION display are the last two digits of the existing year While pressing and holding the buttons turn the control knob until the display shows the correct year Release the buttons and repeat this step for month day hour and minute Note Day and minute settings appear in the PULSE RATE display The N 200 sets the year month day hour and minute sequentially If more than 5
45. log output connectors mproper loading distorts the correspondence between the measured voltage and the intended output voltage 67 Connecting to Other Instruments CONNECTING THE THINKJET PRINTER The Think et printer with an RS 232 serial interface model 2225D may be used to print the contents of the trend and event memories as well as to record ongoing saturation pulse rate pulse amplitude and monitor status Connect the Think et printer to the N 200 as follows 1 Set the N 200 s baud rate to 19 2 K using the baud rate switches 7 and 8 up 2 Set the N 200 format using the RS 232 format switches 3 4 up 5 down Graphics Mode or to another desired format 3 Set the printer s MODE SELECTION switches 1 5 down 6 up 7 8 down 4 Set the printer s RS 232 switches 1 up 2 4 down 5up 5 Connect the printer to the N 200 using the interface cable provided by Nellcor with the Think et printer WARNING Provide the Think et with isolated power If isolated power is not incorporated in the Thinkj et use a standalone isolation transformer 6 Provide isolated power if appropriate turn on the printer verify proper operation and position the paper to start printing near the top of the page Note If the printer s switch settings are changed while it is turned on it must be turned off and back on again to implement those changes 68 Connecting to Other Instruments CONNECTING THE P 200 PRI
46. n the N 200 powerbase Connect the blue end to the unlabeled data input connector on the side of the N 7000 Push each connector in until it snaps into place Route the fiber optic cable without bending it poor transmission may occur if the cable is kinked 65 Connecting to Other Instruments CONNECTING TO THE N 7500 NETWORK Refer to the N 7500 operator s manual for full instructions Nellcor s OXINET N 7500 pulse oximetry network is a radio frequency telemetry system that displays data from as many as eight NELLCOR pulse oximeters such as the N 200 on its central monitoring station The installed N 7500 includes radio interfaces connected NELLCOR pulse oximeters and the central monitoring station To connect the N 7500 to the N 200 set the rear panel DIP switches as follows switches 3 4 5 and 7 down switch 8 up CONNECTING THE N 9000 RECORDER INTERFACE 66 Connect the N 9000 to the N 200 as follows 1 Set the N 200 baud rate switches to 2400 switch 7 down 8 up 2 Set the N 200 RS 232 FORMAT switches to the N 7000 N 9000 recorder format switch sections 3 5 down 3 Connect the gray end of the fiber optic cable provided with the N 9000 to the DATA connector on the N 200 powerbase Connect the blue end to the N 9000 connector labeled DATA INPUT Push each connector in until it snaps into place Route the fiber optic cable without bending it poor transmission may occur if the cable is kinked Refer
47. nection the unit must be operated from its internal battery The N 200 can operate on battery power Typically a new fully charged battery will provide 90 minutes of operation Age and usage will affect battery performance The interface powerbase operates only on AC power Align the red dot on the patient module connector with the red dot on the patient module connection socket Push the connector straight in until it locks do not twist Use only NELLCOR C 13 200 C 20 200 or C 13 200M patient modules If using C LOCKECG synchronization provide an appropriate ECG signal See C LOCK ECG Synchronization later in this section for instructions Apply an appropriate NELLCOR sensor in accordance with its Directions for Use Plug the sensor into the patient module With a C 13 200M patient module close the sensor lock over the plug 27 Guide to Operation 6 Turn on the N 200 using the ON STDBY switch After a few seconds following successful completion of the self test measurements are displayed A beep signals each pulse beat and its pitch increases and decreases to reflect changes in SpO2 If the oximetry pulse signal is lost and pulse is measured only from the ECG the pulse tone changes from a beep to a warble 7 Check the alarm limits each time the N 200 is used by sequentially pressing the HIGH SAT LOW SAT HIGH RATE and LOW RATE buttons 8 Adjust the alarm limits if necessary Press and hold the appropria
48. nterface powerbase is a detachable AC power supply and external interface for the N 200 It provides isolated power for operating the monitor and charging its internal batteries In addition the interface powerbase provides analog and digital outputs for external data recording devices and an input for C LOCK ECG synchronization A fiber optic output can be used to connect the N 200 toa NELLCOR N 7500 pulse oximetry network The patient module models C 13 200 C 20 200 or C 13 200M provides a connector for the oximetry sensor and provides initial oximetry signal processing models C 13 200 and C 20 200 also provide an ECG input connector Automatic Self Test and Startup The N 200 provides immediate use after startup without need for operator calibration or configuration It offers e Automatic self test and error messages e Automatic oximetry calibration e Visible oximetry display e An early warning system that provides an audible indicator for both SpO2 and pulse rate a tone sounds on each pulse and its pitch varies with changes in SpO2 e Operator configured visible and audible oximetry alarms with default alarm limits preset for adults or neonates Features Oximeter Configurable Settings The N 200 provides the operator with the capability to tailor the system for specific clinical applications Capabilities include e Audible alarms that can be silenced the alarm has adjustable volume e C LOCK ECG synchronization t
49. nts occurred The Y packets are not includedin theZn n count lt STX gt E lt CRLF gt lt ETX gt End of data normal completion Command SEND EVENTS Device Sends X lt CRLF gt N 200 Responds lt STX gt X lt CRLF gt lt ETX gt Sent once when command received Z X Y1 Note Square brackets indicate optional items 54 Guide to Operation One or more Z packets each followed by a number of X and Y packets Each Z packet marks the beginning of an event period The number of X packets that follows each Z packet is given by the first parameter Zn n in the Z packet plus one The very last Zn n 1 packet sent is a guard packet used for spacing graphics output The data in this last packet is invalid and should be discarded Hence Zn n gives the number of valid X packets of data points for each event period Thirty seconds that is 30 X packets precede the first Y packet marking the first event There may be more events following each represented by a Y packet spaced among the X packets at the time that the events occurred lt STX gt E lt CRLF gt lt ETX gt End of data normal completion Command STOP SENDING Device Sends V lt CRLF gt N 200 Responds lt STX gt V128 lt CRLF gt lt ETX gt Sent once when command received Note TheY data packets may occur at any time during the trend or event dump The positions of the Y packets indicate when the associated event o
50. olution form Graphics Same as Graphics Up Up Up Model Model but trend data is output only in high resolution graphic form if a printer iS connected NoReal Time Suppresses real Up Down Down Output time data output Graphics low resolution Mode trend and event data is output in graphic form if a printer is connected a Up or down This feature is only available for monitor and powerbase software versions 2 7 3 and higher 64 Connecting to Other Instruments Setting Baud Rate Identify the baud rate required by the device that is to be connected and set the N 200 baud rate using the rear panel baud rate switches switch sections 7 and 8 Refer to Table 6 Table 6 Baud Rate Switch Settings Baud Rate Switch Sections 7 8 1200 Down Down 2400 Down off Up 9600 Up on Down 19200 Up on Up CONNECTING THE N 7000 INTERFACE Note The NELLCOR N 7000 is not available outside the United States The N 7000 provides RS 232 or RS 485 interface capabilities to the N 200 Data from the N 200 is transmitted through a fiber optic cable to the N 7000 The N 7000 outputs data viaa standard 25 pin Dconnector Connect the N 7000 to the N 200 as follows 1 Set the N 200 BAUD RATE switches to 2400 switch 7 down 8 up Set the N 200 RS 232 FORMAT switches to the N 7000 N 9000 format Switches 3 5 down Connect the gray end of the fiber optic cable provided with the N 7000 to the DATA connector o
51. ommunication Protocol sseseeseeseeseeereee 61 Serial Data Connector Pin Assignments 05 61 Communications Formats cccecceeeseeeeeteeeeneeeeees 63 Setting Baud Rate eccceceeeeeeeeeeeeeeeeneeeesneeeeenaees 65 Connecting the N 7000 Interface ceceeeeeeeteeeeeeeees 65 Connecting to the N 7500 Network 66 Connecting the N 9000 Recorder Interface 0 66 Connecting Other Strip Chart Recorders 67 Connecting the Thinkjet Printer 68 Connecting the P 200 Printer seenen 69 Maintenance cccccccccceeeeencceeeeeeeeeeeeeeeneaeneeeeenaeaenseeneaaeees 71 MONVICES TAEPO L T TEATE A ETE ER 71 CleaniN gra a ana iae iiaa a i hin 71 Battery Testing eeccecceeeesseeeeeeeeenneeeeeeeeeeeeeeseneeeeeseenaeeees 71 Determining Software Version s s s 72 Technical Assistance ccccceceeeeeeeeeeeeeeeeeneeeeeetenaeeeeetees 72 Returning the N 200 ccccssceeeeeeeeneeeeeeesneeeeeeeesaeeeeeeeaes 73 Contents Troubleshooting 0 cccccicee te etie eee teneee eee tnnaeeeeetenaeeeeeeniae 75 Status Messages cceeeeeeeeeeeeeteeeeeeeeeeeeeeeeeeaeeeeeaeeeseeeete 75 Troubleshooting Guide c cccceceeeeeeeeeeneeeeeneeeseneeeteneeeee 77 General System Problems ccceceeeeeeeeeeeeeeeneeees 78 General Oximetry Subsystem Problems 0008 79 Trend Memory Problems e 84 Specifications essien un neiinik inisiasie arrine 85 POrf
52. onitor parameters N 9000 Recorder Format This mode is used to communicate with a NELLCOR N 9000 recorder interface Beat to Beat Format This mode transmits saturation and pulse rate data once per beat in the following format STXRnnnSnnnCRLF Trend and Event Command Format The following information describes the data that will be sent to and received from the N 200 The monitor responds to these commands in any of the six ASCII modes Common parameters in these expressions are Text Marker Hexadecimal Meaning of Marker lt STX gt 02H Start of transmission text lt ETX gt 03H End of transmission text lt CRLF gt ODH OAH Carriage return and line feed N 200 data packets are described later in this section 53 Guide to Operation The host device can send one of three commands Command SEND TREND Device Sends W lt CRLF gt N 200 Responds lt STX gt W lt CRLF gt lt ETX gt Sent once when command received Z W Y A Z packet followed by a number of W and Y packets The number of W packets is given by the first parameter Zn nin the Z packet plus one The very last Zn n 1 W packet sent is a guard packet used for spacing graphics output The data in this last W packet is invalid discard them Hence Zn N gives the number of valid W packets or data points If events have occurred during the trend period then Y packets will appear spaced among the W packets at the time that the eve
53. ons WARNING When the AUDIO ALARM OFF button has been pressed and the AUDIO ALARM OFF indicator is illuminated no audio alarm sounds in the event of an adverse patient condition The AUDIO ALARM OFF button must not be used in situations in which patient safety could be compromised Audio and visual alarms can be set for high and low oxygen saturation high and low pulse rate loss of pulse and visual alarm for loss of ECG Audio alarms are interrupted briefly for detected pulses and the volume is adjustable Audio alarms can be disabled for a 60 second period by pressing the AUDIO ALARM OFF button the disable period is adjustable between 30 120 seconds or disabled indefinitely by setting the alarm silence period to OFF The alarm silence indicator blinks continuously when the audible alarm has been disabled Alarm States If the oxygen saturation level or pulse rate moves beyond the alarm limits the corresponding alarm indicator flashes the appropriate display flashes and an audio alarm sounds unless or until it has been silenced If the alarms activate because the pulse signal is lost the OXYGEN SATURATION and PULSE RATE displays flash 0 the PULSE SEARCH indicator flashes and an audio alarm sounds unless or until it has been silenced If C LOCK ECG synchronization is in use and an ECG signal can still be detected PULSE RATE continues to be displayed 29 Guide to Operation 30 If alarms activate because the sens
54. or or patient module is disconnected the displays become blank the PULSE SEARCH indicator flashes and an audio alarm sounds unless or until it has been silenced If C LOCK is in use only the OXYGEN SATURATION display becomes blank If the alarm activates because the ECG signal is lost the ECG LOST indicator flashes This is accompanied by a single low pitch beep to alert the user The audio alarm function can be altered in several ways it can be silenced temporarily it can be disabled and its volume can be adjusted The visible alarm cannot be turned off Checking Alarm Limits Check the alarm limits each time the N 200 is used by sequentially pressing the HIGH SAT LOW SAT HIGH RATE and LOW RATE buttons The unit displays each limit in turn Adjusting Alarm Limits To adjust the alarm limits to meet a specific patient s needs press and hold the appropriate button HIGH SAT LOW SAT HIGH RATE or LOW RATE and turn the control knob until the display shows the desired value Oxygen saturation alarm limits may be set for any value from 20 to 100 and the pulse rate alarm limits may be set for any value from 20 to 250beats per minute The upper limit must be higher than the lower limit Note When the operator turns the N 200 off and back on again alarm limits return to default values Guide to Operation Default Alarm Limits Default alarm limits arein effect when the N 200 is turned on There are two sets of defaul
55. ormat lt STX gt RnnnSnnnPnnnLnnnH nnnOnnnAnnnMnnntTnannnnn Qnnn lt CR gt lt _F gt lt CHKSM gt lt ETX gt R Pulse Rate S Saturation P Pulse Amplitude current sample Low Rate Alarm Limit H High Rate Alarm Limit O Low Saturation Alarm Limit A Alarm Status in ASCI I coded decimal logic 1 alarm condition Bit 0 High Rate Bit 1 Low Rate Bit 2 Low Sat Bit 3 High Sat For example ASCII 005 binary 0101 low sat and high rate alarms M Monitor Status in ASCI coded decimal Bit O Pulse Search Status 1 Locked 0 Search Bit 1 Sensor Status 1 Attached 0O Off Bit 2 Audio Alarm Status 1 Enabled 0 Disabled Bit 3 ECG Status 1 NotinUse 0 InUse Bit 7 Monitor 1 Lost 0 I ntact Communication Guide to Operation For example if the monitor status byte is ASCII 015 binary 00001111 this means that the monitor is locked on pulse sensor attached audio alarms enabled and ECG not in use T Time hhmmss Q High Saturation Alarm Limit n ASCII character normally a number lt CRLF gt Carriage Return and Line Feed lt CHKSM gt 1 Byte Binary Checksum uncoded Conversation Format In this mode the output is a single parameter sent by request only For example the computer requests the current pulse rate by sending an R The interface responds with STX Rnnn CR LF where nnn is the pulse rate Other request codes are listed in the preceding section Conversation Format is available for all m
56. otion or use a new sensor with fresh adhesive backing If the patient is unavoidably active consider using C LOCK ECG synchronization If this is not possible consider using Mode 3 refer to Oximetry Operating Modes in the Guideto Operation section If poor perfusion affects performance consider using an OXISENSOR R 15 adult nasal sensor or a NELLCORRS 10 reflectance sensor The R 15 obtains measurements from an artery supplied by the internal carotid the nasal septal anterior ethmoid artery therefore the R 15 may obtain measurements during low peripheral perfusion The RS 10 obtains measurements from the forehead or temple areas that may be spared when peripheral perfusion is poor 25 GUIDE TO OPERATION Basic Operation Pulse Oximetry Subsystem Features BASIC OPERATION 1 Place the interface powerbase on a flat stable surface Align the N 200 with the interface powerbase Push the N 200 straight in until its latches engage Note The manual applies to all N 200 monitors and powerbases having software versions 2 7 3 or higher see Determining Software Version in the Maintenance section Plug in the power cord to the N 200 power inlet and to an outlet supplying the appropriate mains voltage Use only an outlet that has a grounding connection and the original hospital grade plug and cord or an equivalent hospital grade plug and cord If in doubt about the integrity of the grounding of the mains supply con
57. ow resolution or output to an external device capable of printing ASCII characters or processing and formatting data See the Connecting to Other Instruments section for further information on available formats There are two kinds of events limit events that occur each time the saturation or pulse rate moves beyond the established limits and user defined events that the operator initiates For a limit event the snapshot starts 30 seconds before the beginning of the alarm state and ends 30 seconds after the end of the alarm state If a limit event lasts longer than 60minutes only the first 60 minutes of data are recorded F or a user defined event the snapshot starts 30 seconds before the event is initiated and lasts from 1 to 60 minutes the operator selects the duration User Defined Events Initiating a Fixed Duration User Defined Event A user defined event allows the operator to select times during which event data is acquired Starting 30 seconds before the event is initiated 1 to 60 minutes of data is stored To initiate a user defined event press and hold the HIGH RATE and AUDIO ALARM OFF buttons UdE 0 appears Turn the control knob until the o is replaced by the desired event duration 1 to 60 minutes Then release the buttons The data that is stored in the event memory begins 30 seconds before the buttons are released To change the duration of an ongoing user defined event press and hold the HIGH RATE and AUDIO AL
58. puts 17 FULL button Provides a full scale signal on PULSE SAT and RATE analog outputs The voltage depends on VOLT switch setting 18 SpO2 SCALE switch Sets the analog output scale for oxygen saturation at 0 100 or 50 100 19 VOLT switch Sets the voltage output range for the analog outputs 20 TREND button Initiates a trend memory output sequence 21 EVENT button Initiates an event memory output sequence 22 ECG IN OUT connector Provides an analog ECG output signal or can be used for an input from an external ECG monitor 18 23 24 25 26 27 28 29 30 31 32 33 Setup Baud Rate switches Set the baud rate for serial communications RS 232 Format switches Set the RS 232 format Adult Neonatal Alarm switch Sets the default alarm limits for adults or neonates RATE connector Provides analog voltage output of pulse rate in beats per minute with a range of 0 250 bpm SERIAL COMM connector Provides RS 232 digital interface via a 9 pin D connector SAT connector Provides analog output of oxygen saturation data DATA connector Provides a digital signal via fiber optic output PULSE connector Provides analog output of pulse waveform AC power inlet Fuse compartment Fuse label 19 Setup Rear Panel Switches The rear panel includes eight switches for digital output and adult neonatal alarm limits Table 1 Rear Panel Dip Switch
59. rend data are identified by zero voltage outputs e Thetrend output can be stopped at any time by again pressing the TREND button To restart it push the TREND button again if less than 30 seconds have elapsed the output continues from the point at which it was stopped if more than 30 seconds have elapsed the output starts again at the beginning The following automatic markers appear on the trend graphs printed by an analog strip chart recorder Occurrence Beginning of trend output End of trend output Time when signal is acquired Time when pulse signal is lost Time when N 200 is turned off Event limit or user defined event Marker A 1 second zero voltage output followed by two full scale deflections A 2 second zero voltage output A full scale to current value deflection A full scale to current value deflection A full scale to current value deflection A full scale to zero voltage deflection Note Themonitor can only store 60 events if more than 60 occur only the last 60 will be retained Guide to Operation Events The event memory stores a snapshot of concurrent oxygen saturation pulse rate and pulse amplitude measurements During the snapshot measurements are obtained once every second resulting in a data display that has higher resolution than the trend memory Up to 1 hour of event data may be stored Both trend and event data can be printed in graphic form with either high or l
60. rinter Set up the printer and connect it to the N 200 rear panel SERIAL COMM connector according to the instructions in the Connecting to Other Instruments section To print trend data in graphic form set the N 200 RS 232 format switches to graphics mode or I1 as described in the same section In graphics mode I high resolution or graphics mode I low resolution select either by setting the RS 232 format switches appropriately Low resolution produces a graph that contains one data point for every 50 seconds of saturation and pulse rate data high resolution produces a graph that contains one data point for every 5seconds of saturation and pulse rate data Press the TREND button on the back of the N 200 to begin printing When trend data is printed on a Think et printer up to 12hours of data is printed on one page with the earliest data in the top left portion of the page When low resolution is used each point on the printout represents 50 seconds When high resolution is selected the graph will necessarily be more than one page as each dot represents 5 seconds The oxygen saturation scale is automatically selected based on the range of the data the maximum value is always 100 the minimum value is 50 25 or 0 The pulse rate scale is 0 to 250 beats per minute a narrower range is automatically selected if the data is suited toit Time date hour minute is presented along the horizontal axis 39 Guide to Operation
61. s and hold the AUDIO ALARM OFF button and turn the control knob clockwise until OFF appears on the OXYGEN SATURATION display The AUDIO ALARM OFF indicator light flashes continuously while the audio alarm is disabled The audio alarm can be reactivated by pressing the AUDIO ALARM OFF button again Note When the operator turns the N 200 off and back on again the audio alarm is automatically reenabled and the alarm silence period returns to the default of 60seconds Oximetry Operating Modes The three operating modes of the N 200 enable it to make accurate measurements despite differing levels of patient activity In all three modes the N 200 updates its measurements with every pulse beat Data from the most recent beat replaces data from the oldest beat and new averages are determined and displayed Mode 1 the default operating mode uses a 5 to 7 second averaging time and is useful in situations in which the patient is relatively inactive If the patient is unavoidably active use C LOCK ECG synchronization If this is not possible use Mode3 Mode 2 uses a 2 to 3 second averaging time and therefore is more affected by patient motion It is useful for special applications that require a fast response time such as sleep studies Mode 3 uses a 10 to 15 second averaging time and consequently is least affected by patient motion In this mode pulse rate is not displayed and there is no pulse tone 33 Guide to Operation C
62. s are identified only by tick marks on the horizontal axis Additionally there is a limit of 60 minutes of data that can be stored in event memory regardless of the number of events Guide to Operation Figure 7 illustrates the trend output from a Think et printer 3 Bey a a D R 70 g amp S o 60 we i m z s A 130 130 2 110 110 e E A fad E E Z amp 90 90 aa bes x wa a cn a 3 70 705 a a 50 so 30 30 r1t 18 2 00 3 00 4 00 5 00 6 00 7 09 3725 L2 53 55 586 Figure 7 Sample ThinkJet Trend Graph Note The graph shows an alarm limit event at 2 53 a m on 3 25 L2 53 and the signal lost at 5 58 a m on 3 25 S5 58 Using an Analog Strip Chart Recorder Connect the strip chart recorder to the N 200 as described in the Connecting to Other Instruments section Calibrate the recorder adjust the settings as necessary and confirm proper operation If the N 200 is also connected to a graphics printer that printer must be turned off Otherwise the trend memory will be printed by the graphics printer rather than the strip chart recorder Do not attempt to print trend data on a NELLCOR N 9000 recorder interface 41 Guide to Operation 42 e Toprint the trend memory press the TREND button Data is printed at the rate of approximately 1 hour of data per minute If prior to printing the trend memory the strip chart recorder was printing real time data the beginning and end of the t
63. seconds elapse between any of the steps listed above the changes made so far are stored and the N 200 starts the sequence again beginning with year 2 Allow at least 5 seconds to elapse check settings by pressing the LOW SAT and HIGH RATE buttons simultaneously five times in succession Trends Oxygen saturation and pulse rate measurements are sampled every second and the average of the sampled values is computed every 5seconds That average is then stored in the trend memory Up to 12hours of this data can be stored Both trend and event data can be printed in graphic form with either high or low resolution or output to an external device capable of printing ASCII characters or processing and formatting data Guide to Operation See the Connecting to Other Instruments section for further information on available formats Printing Trend Data Data in the trend memory may be printed graphically on a Hewlett Packard Think et printer with an RS 232 serial interface model 2225D or on an analog strip chart recorder or by using a NELLCOR N 50 powerbase display module Trend data may also be output in ASCII form toa printer or computer To print the contents of trend memory the N 200 must be connected to AC power The instrument continues to function as a monitor while the trend data is being printed The data is retained in memory after printing unless they are erased as described at the end of this section Using a Think et P
64. sion may be inadequate test the monitor on someone else try another sensor see the NELLCOR Sensors section for suggestions Displayed pulse rate does not agree with that of ECG monitor e Excessive patient motion may be making it impossible for the N 200 to find a pulse pattern If possible keep the patient still check whether the sensor is applied securely and properly and replace if necessary use C LOCK ECG synchronization move the sensor toa new site use a sensor that tolerates more motion or set the N 200 for Mode 3 e The patient may have a pronounced dicrotic notch which causes the pulse rate measurement to double Try another sensor site e If C LOCK ECG synchronization is in use an artifact or low quality signal may be present on the ECG monitor Adjust ECG leads to improve quality of ECG signal Refer to the manual for that monitor e An ESU may be interfering Refer to discussion under Item 7 Troubleshooting 11 Oxygen saturation measurement does not correlate with the value calculated from a blood gas determination The SpO2 calculation may not have correctly adjusted for the effects of pH temperature PaCO2 or 2 3 DPG Check whether calculations have been corrected appropriately for relevant variables See the Principles of Operation section for more information In general calculated saturation values are not as reliable as direct laboratory hemoximeter measurements Accuracy can be affected by
65. t The oxygen saturation scale is automatically selected based on the range of the data the maximum value is 100 the minimum value is 50 25 or 0 The pulse rate scale is based on the range of the measurements 45 Guide to Operation 46 Figure 8 illustrates event output on a Thinkj et printer SAT Sa02 PATIENT EVENT GRAPH by NELLCOR PULSE BPM PLS AMPL Note 4 100 98 80 70 68 se 145 100 T a 125 105 85 65 A PULSE BPM 45 16 38 16 39 16 48 16 41 SAT Sa02 PLS AMPL 100 1 98 8a 70 60 se 135 135 115 9s 95 to 75 5S 35 115 Ll 3724 L14 26 Figure 8 Sample ThinkJet Event Graph A user defined event started at 4 37 p m on 3 22 E 16 37 and an alarm limit event started at 2 20p m on 3 24 L14 20 To Determine the Number of Events in Memory press and hold the LOW SAT and LOW RATE buttons If no events are stored in event memory no E is displayed if 60 or fewer events are stored in event memory nn E is displayed If more than 60 events occur only the last 60 are available o SAT Sa02 a 50 5S 35 PULSE BPM PLS ANPL Guide to Operation To Print a Specific Event press the LOW SAT and LOW RATE buttons and turn the control knob until the identifier for the desired event appears in the display Then release the buttons and within 10 seconds press t
66. t alarm limits one for adults and one for neonates as shown in Table 3 Table 3 Default Alarm Settings Adult Neonatal Adjustable Alarm Limit Setting Setting Range High oxygen saturation 100 95 20 100 Low oxygen saturation 85 80 20 100 High pulse rate 140bpm 200 bpm 20 250 Low pulse rate 55 bpm 100 bpm 20 250 Note When the operator turns the N 200 off and back on again alarm limits return to default values To determine whether the default alarm limits are set for an adult or a neonate press the HIGH SAT button immediately after turning on the N 200 If the instrument is set for an adult 100 appears in the OXYGEN SATURATION display if it is set for a neonate 95 appears Changing From Adult to Neonatal Alarm Limits To change the adult neonatal setting move the adult neonatal alarm switch UP to change the setting to adult default limits DOWN for neonatal default limits Turn the N 200 off and back on to reset default settings refer to Table 1 Note When changing settings the N 200 must be operating on AC power for the change to be implemented 31 Guide to Operation 32 Adjusting Audio Alarm Volume WARNING Do not set the alarm volume too low to be heard WARNING When the AUDIO ALARM OFF button has been pressed and the AUDIO ALARM OFF indicator is illuminated no audio alarm sounds in the event of an adverse patient condition The AUDIO ALARM OFF button must not be used in situations in which patient
67. te alarm button and turn the control knob until the desired value is displayed SpO2 alarm limits may be set from 20 to 100 Pulse rate alarm limits may be set from 20 to 250 beats per minute The upper limit must be higher than the lower limit Note When the N 200 is turned off and back on all operator adjustable features return to their default state PULSE OXIMETRY SUBSYSTEM FEATURES The pulse oximetry subsystem of the N 200 measures and displays SpO2 and pulse rate and provides data for alarms and for the trend memory Pulse Tone 28 When a NELLCOR sensor is connected to the N 200 and a patient the pulse beat is signaled by a beep that varies in pitch to reflect changes in oxygen saturation rising as saturation increases and falling as it decreases When the N 200 is receiving only an ECG derived signal no sensor derived optical signal each detected R wave is signaled by a high pitched tone that has a slight warble This tone is distinct from any beep heard when a sensor derived signal is present The pitch of the warbling tone that accompanies an ECG derived signal is not related to oxygen saturation Guide to Operation The pitch of the warbling tone is also significantly higher than any beep that reflects oxygen saturation Changing Pulse Tone Volume Turn the control knob to adjust pulse tone volume When the N 200 is turned off and back on again the pulse tone returns to its default volume Alarm Functi
68. th the N 200 Validation testing of D 25 and N 25 sensors was conducted on adult volunteers Saturation accuracy will vary by sensor type Refer to the Sensor Accuracy Grid 4 Definition of Low Perfusion Low perfusion in the context of oximetry is generally used to mean that the detected signal modulation pulsatility is low at the monitoring site Low percent modulation is defined as a value of 1 5 modulation or less for the infrared IR signal Specification applies to monitor performance and was validated with Biotek and Nellcor simulators 86 Specifications ECG Direct ECG input Via C 13 200 or C 20 200 patient module Input Defibrillator protected differential Lead II only Bandwidth 0 5 40 Hz monitoring bandwidth CMRR Greater than 100 dB at 50 or 60 Hz with 5 kilohms source imbalance Input Range 0 5 5 0 mV for QRS detection Input Impedance greater than 10 megohms Via Rear Panel ECG IN OUT Connector Input Defibrillator sync or ECG output waveform from bedside ECG monitor Defibrillator protected differential standard Lead II configuration For optimum performance waveform with positive deflection recommended Input Range 0 5 V minimum input signal should not exceed 15 V Minimum of 10 ms wide at 50 of peak amplitude delayed by no more than 40 ms from actual QRS complex 87 Specifications Digital Data Output RS 232 Connector 9 pin D type subminiature female Baud Rate
69. the ECG signal must be between 0 5 and 15volts The QRS complex must be at least 10 milliseconds wide at 50 of peak amplitude To ensure optimal performance the output signal should be delayed by no more than 40milliseconds from the actual QRS complex For direct patient connected ECG signals the R wave amplitude must be between 0 5 and 5 0millivolts Guide to Operation Lost ECG Signal If the ECG signal is lost or deteriorates to the extent that the N 200 can no longer track it the ECG LOST indicator flashes When the ECG signal is lost oximetry measurements will continue to be derived from the optical sensor signal During this time the N 200 continues to search for an ECG signal and when it finds an adequate signal C LOCK ECG synchronization again becomes active To cancel the ECG LOST indication press the AUDIO ALARM OFF button When using C LOCK ECG synchronization either an electrosurgical unit or significant upper body muscular activity may disrupt the ECG signal and cause the N 200 to begin using the optical signal alone for obtaining measurements When an adequate ECG signal is again available C LOCK ECG synchronization resumes functioning automatically Direct Low Level ECG Input To use direct ECG input position three conventional electrodes in the standard limb lead configuration as illustrated in Figure6 When applying the electrodes follow all appropriate instructions and observe institutional standards Dire
70. ting 80 Excessive patient motion may be making it impossible for the N 200 to find a pulse pattern If possible keep the patient still check whether the sensor is applied securely and properly and replace if necessary use C LOCK ECG synchronization move the sensor toa new site use a sensor that tolerates more motion or set the N 200 for Mode 3 The sensor may be damaged replace it The patient s perfusion may be too low to allow the N 200 to measure saturation and pulse rate Patient module cannot be connected Use only a NELLCORC 13 200 C 20 200 or C 13 200M patient module Connector pins may be bent replace the patient module SpO2 or pulse rate change rapidly pulse amplitude indicator is erratic ECG waveform is noisy Check the patient Excessive patient motion may be making it impossible for the N 200 to find a pulse pattern If possible keep the patient still check whether the sensor is applied securely and properly and replace it if necessary use C LOCK ECG synchronization move the sensor toa new site use a sensor that tolerates more motion or set the N 200 for Mode 3 An electrosurgical unit ESU may be interfering with performance Move the N 200 the patient module and the cables as far from the electrosurgical unit as possible Plug the N 200 and the electrosurgical unit into different AC power supply Troubleshooting Move the electrosurgical unit ground pad as close to th
71. to the N 9000 operator s manual for complete operating instructions Connecting to Other Instruments CONNECTING OTHER STRIP CHART RECORDERS A general purpose strip chart recorder may be connected to the N 200 to provide a permanent record of oxygen saturation pulse rate pulse waveform ECG data and or data in the trend and event memories The N 200 analog output connectors are standard 3 32 in subminiature phone plugs The output voltage range required by the recorder 0 1 V or 0 10 V is set with the N 200 VOLTAGE switch The oxygen saturation output can be set for a 0 100 display or an expanded 50 100 display using the N 200 SpO2 SCALE switch The pulse rate output is 0 1 V or 0 10 V with a range of 0 255 bpm and a resolution of 3 9 or 39mV per beat To print oxygen saturation and pulse rate use the SAT and RATE connectors Usethe ZERO and FULL buttons to generate zero and full scale voltage signals in order to adjust the recorder controls To print the pulse plethysmographic waveform use the PULSE connector to print the ECG waveform use the ECG IN OUT connector Use the ZERO and FULL buttons to generate zero and full scale voltage signals at the PULSE connector in order to adjust the recorder controls To print trend data on a strip chart recorder use the SAT and RATE connectors to print event data usethe SAT RATE and PULSE connectors Note Connect only a high impedance device 1 megohm or higher to the ana
72. tput in either high or low resolution Transmission of trend and event information can be initiated either by an external command or with the rear panel TREND and EVENT buttons Similarly transmission can be stopped either by external command or with the rear pane buttons Upon receiving a command to output either trend or event information the N 200 checks the serial communications port to see if an ASCII device is connected If the DSR signal input pin 6 on the SERIAL COMM connector is not true no output occurs Hence any ASCII device connected to the N 200 must drive the DSR pin 6 toa logic true to output trend and event data to the serial communications port Interface Powerbase 58 The interface powerbase is the detachable AC power supply and external interface for the N 200 It provides isolated power for operating the monitor and for recharging the batteries Also the powerbase contains the circuits required to communicate with the monitor The powerbase provides analog outputs of pulse waveform oxygen saturation and pulse rate data ECG waveform and a digital output connector RS 232 serial interface In addition it also provides a fiber optic output connector for use with the NELLCOR N 7000 interface the OXINET N 7500 pulse oximetry network or the N 9000 recorder interface Guide to Operation Because the N 200 is patient isolated the monitor and powerbase communicate through a bidirectional optical link t
73. tware versions in the powerbase and monitor To determine the powerbase and N 200 software version refer to the Maintenance section ALARMS ACTIVE NONE or LOW SATURATION HIGH SATURATION LOW RATE HIGH RATE LIMITS LOW RATE nnn HIGH RATE nnn LOW SAT nnn HIGH SAT nnn If the N 200 is turned off or the interface power base is detached from the monitor the following sequence is transmitted immediately and again once each minute HH MM SS COMMUNICATIONS WITH MONITOR LOST Computer and Alternate Computer Format Two computer compatible digital output formats are available Format is selected on the rear panel DIP switch see Table 1 1 Select Computer Format by setting switch section 3 down 4 up 5 down 2 Set switch section 2 up when the N 200 is transmitting data to a Spacelabs 90600 series ECG monitor Alternate Computer F ormat Otherwise set switch section 2 down Computer F ormat 51 Guide to Operation 52 3 Switch section 2 up Alternate Computer F ormat and to some Spacelabs monitors Once every 10 seconds and when the status or limits change the following data is transmitted lt STX gt RnnnSnnnPnnnLnannH nnnOnnnAnnnMnnntTnannnnn Qnnn lt CR gt lt _F gt lt ETX gt lt CHKSM gt lt ETX gt Note STX start of transmission and ETX end of transmission are shown in hexadecimal equivalents above their positions in the string CHKSM stands for checksum 4 Switch section 2 down normal computer f
74. uired to fully recharge the battery If C LOCK ECG synchronization is used when the N 200 is operating on battery power the ECG signal must be supplied directly from the patient through an ECG cable attached to the C 13 200 or C 20 200 patient module When using battery power a signal from a bedside ECG monitor cannot be used 59 CONNECTING TO OTHER INSTRUMENTS Overview RS 232 Communication Protocol Connecting the N 7000 Interface Connecting the N 7500 Network Connecting the N 9000 Recorder Interface Connecting Other Strip Chart Recorders Connecting the ThinkJet Printer Connecting the P 200 Printer OVERVIEW WARNING When connecting this monitor to any instrument verify proper operation before clinical use Refer to the other device manual for full instructions Accessory equipment connected to the monitor analog or digital outputs must be certified according to the respective standards that is IEC 950 for data processing equipment or IEC 601 1 for electromedical equipment and must comply with the requirements for medical systems IEC 601 1 1 If in doubt contact Nellcor Technical Services Department or your local Nellcor representative This section contains information to allow the user to provide serial communications between the N 200 and external digital devices RS 232 COMMUNICATION PROTOCOL Serial Data Connector Pin Assignments Table 4 lists pin assignments on the rear panel SERIAL COMM connector and t
75. use A P DURA Y nonsterile reusable D YS OXIBAND nonsterile reusable OXI A N OXI P I DURASENSOR nonsterile DS 100A reusable NELLCOR reflectance sensor RS 10 nonsterile limited reuse CLEANING AND REUSE 24 Patient Weight lt 3 kg gt 40 kg 3 to20 kg 10 to 50 kg gt 30 kg gt 50 kg gt 30 kg 10 to 50 kg gt l kg lt 3 kg 0 kg 3 to 40 kg gt 40 kg gt 40 kg Caution Do not sterilize any NELLCORsensor or adhesive by irradiation steam or ethylene oxide and do not immerse in water or cleaning solutions Clean the surface of reusable sensors by wiping with an agent such as 70 isopropyl alcohol When using adhesive sensors use a new adhesive sensor wrap or bandage for each patient NELLCOR Sensors PERFORMANCE CONSIDERATIONS Always select an appropriate sensor apply it as directed and observe all warnings and cautions If ambient light affects performance ensure that the sensor is properly applied and cover the sensor site with opaque material Failure to do so may result in inaccurate measurements Light sources that can affect performance include surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight If patient movement presents a problem verify that the sensor is properly and securely applied move the sensor to a less active site use an adhesive sensor that tolerates some patient m

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