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1. c 4 Press the Pulse Rate Alarm Limit button twice to view the current Pulse Rate lower alarm limit 32 Using the N 550 psa d t Seo A 5 Press the SatSeconds Alarm Limit button to view the current SatSeconds setting pa Spaz Kt LA SatSeconds units are being reviewed The SatSeconds 12 9 Note The SatSeconds 12 O clock indicator lights indicating that O clock indicator lights for all SatSeconds except Off Alarm Limits Changed Indicator N 550 If an alarm limit is changed from the N 550 s power on default setting a decimal point appears after the applicable displayed value during patient monitoring and when alarm limits are viewed The decimal point remains on the display until the N 550 is turned off or the limit is returned to the default value pa e 8 E E 990 33 Using the N 550 Alarm limits that have been changed from the default setting are identified by a decimal point after the displayed reading SpO2 or Pulse Rate Setting Alarm Limits Discussion Alarm limits determine the upper and lower points of patient data at which the N 550 will sound an alarm Procedure With the N 550 in the normal monitoring mode 1 Press SpO2 Alarm Limit button to view the current SpO2 upper alarm limit C 2 Press the Adjust Up button or Adjust Down button to increase or G2 decrease the alarm limit set
2. Figure 1 Front Panel Buttons and Symbols 1 SpO Sensor Port 12 SatSeconds Alarm Limit Button 2 Power On Off Button 13 SpO2 Alarm Limit Button 3 96SpO2 Display 14 Motion Indicator 4 Pulse Amplitude Indicator 5 Pulse Rate Display 15 Sensor Off Indicator 16 Sensor Message Indicator 6 Alarm Silence Button 17 Pulse Search Indicator 7 Alarm Silence Indicator 18 Data In Sensor Indicator 8 Adjust Up Button 19 Low Battery Indicator 9 Adjust Down Button 20 AC Power Indicator 10 Pulse Rate Alarm Limit Button 2 Speaker 11 SatSeconds Display Description of Controls Indicators and Symbols Identification of Rear Panel Components 1 Data Port Connector 3 AC Power Connector 2 Foot Switch and Visual 4 Equipotential Connector Alarm Connector ground Figure 2 Rear Panel Symbols N 550 Symbols The symbols that are located on the rear panel of the N 550 are as follows Data Interface 3 Foot Switch 2 Caution Do not connect 4 Equipotential Terminal while power is on ground Description of Controls Indicators and Symbols The symbols that are located on the front panel of the N 550 are as follows s 9 gt 1 Type BF Applied Part 6 Pulse Search Not Defibrillator Proof
3. seeeeeesse 27 Setting the Alarm Volume oreet rnt itus 28 Setting Alarm Silence Duration esses 28 DiscussiOn cccccccececcecaesesssecececeececeusaaeseseeeeeeseaeaanees 28 Proced tr i d RI eoErate Pn Perse 29 Disabling Audible Alarms eene 30 DISCUSSION iiti REIHE EMI 30 Proced re 5 nne eret iion tiras 30 Verify Patient Settings eeeseseseseseeeeeeee 31 Alarm Limits Changed Indicator sesssssssss 33 Setting Alarm Limits cati steterit ta npe Etettdo net eret 34 DISCUSSION c cccecececcecaesesssecececeeceseuaeeuseseseeeeseaeaagees 34 Procedure n Lum 34 Setting SatSeconds Duration sss 36 DISCUSSIOTnL 2 pco teret eee odo eut Rad 36 Proced l tette thee dete Peru 36 Setting the Data Port Baud Rate sssssussss 37 DISCUSSION ii DERI EMI MEN 37 PROCCQUNC EE 37 Setting the Data Port Protocol eeesssssssssss 39 Clearing Trend Information ssssssseeseeeeeesses 40 N S90 TODO uusderauesdeiteXxs qao FERREA T RCLARS DAVE ECT eens 43 Trend Data Operation sesessseeeseeeee 43 Trend Data iin erede etie tens 43 1 Trend Pr eio rorem Mae 44 42 Trend Cleat uh E MERE 44 32 Not Used nn nein 44 4 Baud Rate ccccccecccecccecsesesseeeeeecescaeseaeaseeeeeeeeeees 44 5 Da
4. f 5 f 5 9 M t e CJ 4 Press the Adjust Up button or Adjust Down button to select the desired protocol Possible settings are e 1 ASCII 2 External equipment communications Refer to the external equipment manuals for the interfacing instructions Clearing Trend Information With the N 550 in the normal monitoring mode 1 Simultaneously press and hold the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for at least 3 seconds Option 1 will be displayed 2 Press the Adjust Up button to select Option 2 40 Using the N 550 som TR 3 Press the SatSeconds Alarm Limit button to clear the trend data The N 550 emits 3 beeps indicating that data is cleared N 550 41 Blank Page N 550 Trend Trend Data Operation From the initial measurement of a patient trend data a data point is stored in memory every 4 seconds Up to 50 alarm limit changes can also be stored in trend data The N 550 can store up to 24 hours of trend data The N 550 trend data will be lost if the coin cell battery fails or is removed The coin cell battery is located on the main circuit board CAUTION Changing alarm limit settings uses trend memory space Change alarm limits only as needed data with newly collected data overwriting the oldest data on a rolling basis The N 550 continues to record data points as long as the N 550 is powered on and an initial patient measurement has been
5. e If the N 550 is operating on AC power the fuse may be blown Notify service personnel to check and if necessary replace the fuse e If the N 550 is on battery power the battery fuse may require replacement the battery may be missing or the battery may be discharged Charge the battery or notify service personnel to replace the battery or the battery fuse as required One or more display segments or indicators do not light during the power on self test e Do not use the N 550 contact qualified service personnel or your local Nellcor representative The N 550 does not sound a tone indicating successful completion of the Power On Self Test POST e The N 550 has failed the power on self test Do not use the N 550 This tone not only indicates the successful completion of POST but it confirms that the audible alarm is functional Contact qualified service personnel or your local Nellcor representative The Pulse Search indicator is lit for more than 10 seconds while the sensor is connected to the patient e Check the sensor directions for use to determine if an appropriate sensor is being used and if it 1s applied properly Check sensor and sensor cable connections Test the sensor on someone else Try another sensor or sensor cable 79 Troubleshooting 80 e Perfusion may be too low for the N 550 to track the pulse Check the patient Test the N 550 on someone else Change the sensor site Try another type of sens
6. Operation during vibration TEC 60068 2 6 and IEC 60068 2 34 Cleaning IEC 60601 1 sub clause 44 7 Case surface made of non toxic materials Case resistant to heat and fire IEC 60601 1 sub clause 48 IEC 60601 1 sub clause 59 2 b N 550 power entry module fuse holder IEC 60601 1 sub clause 59 3 N 550 exterior markings Front panel and case labeling IEC 60601 1 sub clause 6 1 6 3 and 6 4 EN 865 clause 6 IEC 60878 EN 980 ISO 7000 EN 60417 1 EN 60417 2 N 550 button spacing ISO 7250 Year of manufacture symbol EN 980 Electromagnetic Compatibility IEC 60601 1 sub clause 36 IEC EN 60601 1 2 1993 Radiated and conducted emissions EN 55011 Group 1 Class B Harmonic emissions IEC 61000 3 2 N 550 Item Specifications Compliant With Voltage fluctuations flicker emissions IEC 61000 3 3 Electrostatic discharge immunity EN 61000 4 2 level 3 table top equipment Radiated radio frequency electromagnetic field immunity IEC 61000 4 3 3 V m 1 kHz Electrical fast transient burst immunity Surge immunity IEC 61000 4 4 0 5 kV signal cable 1 kV AC mains IEC 61000 4 5 level 3 Conducted EMI susceptibility IEC 61000 4 6 3 Vrms 1 kHz Power frequency magnetic fields IEC 61000 4 8 100 A m 50 Hz Operation with line voltage variations IEC 61000 4 11 107 Blank Page I
7. Saturation Without Motion Adults 70 to 100 2 digits Without Motion Neonate With Motion Adults and Neonates 70 to 100 3 digits 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 physiological range 55 125 bpm 5 digits Low Perfusion N 550 20 to 250 bpm 3 digits 97 Specifications 98 Accuracy and Motion Tolerance Adult specifications are shown for OxiMAx MAX A and MAX N sensors with the N 550 Neonate specifications are shown for OxiMAx MAX N sensors with the N 550 Saturation accuracy will vary by sensor type Refer to the Sensor Accuracy Grid 2 Applicability Ox Max MAX A MAX AL MAX P MAX I and MAX N sensors x Specification applies to N 550 performance Table 6 Tone Definition Audible Indicator Parameter Value Alarm Silence Volume level Not changeable Reminder Pitch 30 Hz 784 Hz Pulse width 20 msec 150 msec Pulse repetition interval 150 msec 20 msec double burst Repetitions 3 Confirmation of Volume level Not changeable Button Pressed Pitch 30 Hz 784 Hz Pulse width 20 msec 150 msec Pulse repetition interval 150 msec 20 msec double burst Repetitions 3 N 550 Audible Indicator Table 6 Tone Definition Parameter Specifications Value High Priority Alarm Volume level Ad
8. limits If no data for a parameter is available three dashes are displayed PA represents pulse amplitude The number can range from 0 to 254 There are no alarm parameters for this value It can be used for trending information as an indication of a change in pulse volume relative pulse strength or circulation N 550 Version 1 00 00 CRC XXXX SpO2 Limit 85 100 PR Limit 40 170 bpm ADULT 0 SAT S TIME 9 6SpO2 PR bpm PA Status 30 Sep 03 16 00 00 100 190 220 PH The Status column indicates alarm conditions and operating status of the N 550 In this example Pulse High PH means that the pulse rate upper alarm limit has been exceeded The status codes are listed below As many as four codes can be displayed at one time in the Status column Code Meaning AO Alarm Off 63 Printing 64 Code Meaning AS Alarm Silence LB Low Battery LM Loss of Pulse w Motion LP Loss of Pulse MO Patient MOtion PH Pulse Rate Upper Limit Alarm PL Pulse Rate Lower Limit Alarm PS Pulse Search SH Saturation Upper Limit Alarm SL Saturation Lower Limit Alarm SD Sensor Disconnect SO Sensor Off to be displayed in the patient data section of the printout 9 Note A sensor disconnect and sensor off will also cause three dashes Sensors and Accessories Sensors and Accessories Selecting a Sensor N 550 A g
9. vi Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Data Port Pinouts ccccccescsssseseseeeeseseeeseeeeeeeees 48 Nellcor Oximetry Sensor Models and Patient Weights eeeeeeeees 66 Operator s Menu 1ssioscecus cen tonc Sex PEE cv ooo a dpa ERO ERE 75 Error Codes cette ERR IER RES 78 Factory Default Settings sssssses 88 Tone Definition sirsiran 98 Safety Information Warnings A A A N 550 A Warnings are identified by the WARNING symbol shown above Warnings alert the user to potential serious outcomes death injury or adverse events to the patient or user WARNING Explosion hazard Do not use the N 550 pulse oximeter in the presence of flammable anesthetics or gases WARNING Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions See the appropriate sections of the manual for specific safety information WARNING Ensure that the speaker is clear of any obstruction Failure to do so could result in an inaudible alarm tone Safety Information Cautions e Cautions are identified by the CAUTION symbol shown above Cautions alert the user to exercise care necessary for the safe and effective use of the N 550 CAUTION When connecting the N 550 to any instrument verify proper operation before clinical use Bo
10. 2 Pulse Rate 7 Data In Sensor 3 Motion 8 Low Battery 4 Sensor Off 9 AC Power Battery Charge 5 Sensor Message Description of Controls result in either a valid or an invalid button tone If the button pressed fails to emit a tone contact qualified service personnel The Power On Off button is used to turn the N 550 on or off 9 Note Each button press except the Power On Off button should N 550 Description of Controls Indicators and Symbols 10 IN 2 is The Alarm Silence button is used to silence current alarms for the alarm silence duration period When an alarm has been silenced pressing the button again reactivates or unsilences the alarm It is also used to view and adjust alarm silence duration and alarm volume The Adjust Up button is used to increase alarm limit values alarm silence duration pulse beep volume alarm volume and data port baud rate The Adjust Up button is used to select the communication protocol and time settings Press the Adjust Up button one time to increase the display by one digit Holding the Adjust Up button down for more than one second cause the display digits to scroll The Adjust Down button is used to decrease alarm limit values alarm silence duration pulse beep volume alarm volume and data port baud rate The Adjust Down button is used to select the communication protocol and time settings Press the Adjust Down b
11. 30 Hz 296 Hz to 662 Hz varies with saturation Pulse width 20 msec 40 msec Pulse repetition interval N A msec 20 msec double burst Repetitions 1 100 Electrical N 550 Table 6 Tone Definition Specifications Audible Indicator Parameter Value Valid Button Press Volume level Not changeable Pitch 30 Hz 784 Hz Pulse width 20 msec 30 msec Pulse repetition interval 20 msec double burst N A Repetitions 1 Volume Setting Volume level Adjustable alarm volume Pitch 30 Hz 752 Hz Pulse width 20 msec Infinite Pulse repetition interval N A 20 msec double burst Repetitions N A Instrument Power 100 to 240 volts AC 18 to 26 volt amps to Requirements be compliant with IEC 60601 1 sub clause 10 2 2 Fuses qty 2 2 A 250 volts slow blow IEC 5 x 20 mm Battery The battery provides at least 1 5 to 2 hours of battery life when new and fully charged with no alarms no serial data and no nurse call outputs while using a pulse simulator set for 200 bpm high light and low modulation Type Lead acid 101 Specifications Battery Voltage 12 Volts DC 1 2 AH Recharge e 11 hours with N 550 turned off e 12 hours with N 550 operating Shelf Life e 2 months new fully charged battery e After 2 months storage the N 550 will run for 50 of stated battery life Sensors Wavelength The wavele
12. Do not make any clinical judgments based on the oximeter s measurements only Intended Use for the N 550 N 550 The N 550 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate The N 550 is intended for use with neonatal pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospitals hospital type facilities intra hospital transport and home environments For prescription use only Note Hospital use typically covers such areas as general care floors operating rooms special procedure areas intensive and critical care areas within the hospital plus hospital type facilities Hospital type facilities include physician office based facilities sleep labs skilled nursing facilities surgicenters and sub acute centers Intra hospital transport includes transport of a patient within the hospital or hospital type facility Use with any particular patient requires the selection of an appropriate oxygen transducer sensor as described in this Operator s Manual Motion performance claims are applicable to models MAX A MAX AL MAX P MAX N and MAX I Nellcor OxiMax oximetry sensors Blank Page Description of Controls Indicators and Symbols Identification of Front Panel Buttons and Symbols N 550 N t san aes if I eo Co Co
13. N 550 will produce no audible alarms Visual indications of an alarm condition are not affected by disabling the audible alarms The ability to set the alarm silence duration to OFF can be enabled or disabled by qualified service personnel as described in the service manual WARNING Do not silence the audible alarm or decrease its volume if patient safety could be compromised Procedure With the N 550 in the normal monitoring mode 30 Using the N 550 E 1 Press the Alarm Silence button until XX SEC is displayed 2st890 2 While pressing the Alarm Silence button press and hold the Adjust Up button until OFF is displayed Release buttons m gos Rl 3 The Alarm Silence indicator will flash indicating that the alarm sounds are disabled The N 550 will sound three beeps approximately every three minutes to warn the user that the alarm sound has been silenced Verify Patient Settings With the N 550 in the normal monitoring mode 1 Press the SpO2 Alarm Limit button to view the current SpOz2 upper alarm limit N 550 31 Using the N 550 2l mt f gt a v oy 2 Press the SpO2 Alarm Limit button twice to view the current SpO2 lower alarm limit 2l i T 9I I 990 3 Press the Pulse Rate Alarm Limit button to view the current Pulse Rate upper alarm limit 2l i g gt f ooo
14. TXD RS 422 negative output 13 NC 14 NC 15 Nurse Call Common The pin layouts as viewed from the rear panel of the N 550 are illustrated in Figure 3 The conductive shell is connected to earth ground when connected to a PC or printer 9 10 11 12 13 14 15 23 45 67 8 1 Figure 3 Data Port Pin Layout Pins 2 3 5 and 11 provide data in RS 232 format Pins 1 4 9 and 12 provide data in RS 422 format TXD and TXD are the differential transmit data pair RXD and RXD are the differential receive pair Use the Data Port Setup procedure to configure the N 550 data port baud rate and protocol 49 Using the Data Port Procedure With the N 550 in the normal operating mode 1 Simultaneously press and hold the SpOz Alarm Limit button and Pulse Rate Alarm Limit button for at least 3 seconds Option 1 will be displayed in e j Just 2 Press the Adjust Up button until Option 4 is displayed na i Hj E stS900 3 Press the SatSeconds Alarm Limit Button to select Option 4 The selected baud rate will be displayed 50 Using the Data Port pa dt t Seo f Note The available selections are e 24 2400 baud rate e 96 9600 baud rate e 192 19200 baud rate 4 Press the Adjust Up button or the Adjust Down button to select the desired baud rate rate TR 5 Press the SatSeconds Alarm Limit bu
15. as carboxyhemoglobin or methemoglobin In contrast hemoximeters such as the IL482 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 fractional saturation fractional measurements must be converted as follows fractional saturation functional saturation 1hHJmMHH x1 100 96 carboxyhemoglobin methemoglobin 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 pH temperature the partial pressure of carbon dioxide PCO2 2 3 DPG and fetal hemoglobin See Figure 7 on page 96 N 550 95 Principles of Operation 96 Saturation 100 50 t pH Temperature PCO2 7 2 3 DPG m t Fetal Hb di pH t Temperature t PCO2 t 2 3 DPG 50 100 PO mmHg Figure 7 Oxyhemoglobin Dissociation Curve Specifications Performance Measurement Range SpO2 Pulse Rate 1 to 100 0 and 20 beats per minute bpm to 250 bpm Perfusion Range 0 03 to 20 Accuracy and Motion Tolerance
16. made with blank data points collected if no sensor is connected to the N 550 or patient Blank data will overwrite older patient data if the memory becomes full Therefore if you want to save old patient data it is important that you turn your N 550 off when you are not monitoring a patient and that you download the trend memory before it fills up and overwrites the old data with new data or blank data 9 Note Trend memory always contains the most recent 24 hours of Trend Data Trend data information may be retrieved or cleared through the N 550 data port using options available in a display menu N 550 43 N 550 Trend To access the menu options simultaneously press the SpO2 Alarm Limit and Pulse Rate Alarm Limit buttons until Option 1 appears on the display er con 25558 4 E L Then using the Adjust Up button and Adjust Down button you may G2 scroll through the available menu options as follows 1 Trend Print on a PC using the Hyper Terminal program You must press the SatSeconds Alarm Limit button to initiate printing Refer to Trend Data Printout on page 59 Le Allows printing of the existing trend data The output may be viewed 2 Trend Clear Clears the existing trend data To activate press the SatSeconds Alarm Limit button 3 Not Used 4 Baud Rate Allows the interconnection to various printers Refer to Setting the Data Port Baud Rate o
17. sensor single pateint use adult 52 5 mW OXIMAX adhesive sensor single pateint use adult 52 5 mW longer cable 36 inches 91 44 cm OXIMAX adhesive sensor single pateint use neonatal 52 5 mW adult OXIMAx adhesive sensor single pateint use pediatric 52 5 mW OXIMAX adhesive sensor single pateint use infant 52 5 mW 103 Specifications Ox1Max Sensor Power Dissipation Physical Characteristics 104 OxiMAx Sensor Dissipation OXIMAX adhesive sensor single pateint use adult nasal 52 5 mW OXIMAX OxiCliq nonadhesive sensor single patient 52 5 mW use adult reusable cable OXIMAX OxiCliq nonadhesive sensor single patient 52 5 mW use neonatal adult reusable cable OXIMAX OxiCliq nonadhesive sensor single patient 52 5 mW use pediatric reusable cable OXIMAX OxiCliq nonadhesive sensor single patient 52 5 mW use infant reusable cable OXIMAX Durasensor finger clip sensor reusable adult 52 5 mW OxIMAX Oxiband sensor reusable neonatal adult 52 5 mW OXIMAX Oxiband sensor reusable pediatric infant 52 5 mW OXIMAX Dura Y multisite sensor reusable 52 5 mW Weight 3 07 Ibs 1 39 kg without pole mount Dimensions 2 87 in x 7 87 in x 5 in 7 3 cm x 20 cm x 12 7cm Compliance N 550 Item Specifications Compliant With Equipment classification Safety Standards IEC 60601 1 same as EN60601 1 EN475 EN865 EN IEC 60
18. shorter It is recommended that qualified service personnel replace the internal battery every 24 months CAUTION If the N 550 is to be stored for 2 months or longer notify service personnel to remove the battery from the N 550 prior to storage Recharge the battery when it has not been charged for 2 or more months The Low Battery Indicator flashes and a high priority alarm begins to sound when the battery reaches the lowest battery voltage at which an N 550 can support normal operation This alarm cannot be silenced while running on battery power If the N 550 is not connected to AC power the N 550 will shut off after 10 seconds Using the N 550 Turning on the N 550 Discussion Procedure N 550 96 Before using the N 550 in a clinical setting you must verify that the N 550 is working properly and is safe to use Proper working condition can be verified by successful completion of the Power On Self Test POST described in the following section WARNING The N 550 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the N 550 should be observed to verify normal operation in the configuration in which it is used CAUTION If any indicator or display element does not light or the speaker does not sound do not use the N 550 Instead contact qualified service personnel your local Nellcor representative or Nellcor s Technical Services Department 1 800 635 52
19. silence duration the alarm silence duration is ended and the audible alarms are re enabled Visual indications of an alarm condition cannot be turned off For example if the SpOz2 lower alarm limit is exceeded the alarm can be silenced for the alarm silence duration but the SpO2 value will continue to flash If the alarm condition is still present when the alarm silence duration has elapsed the alarm will sound The power on default setting for audible alarm silence duration is set at the factory to 60 seconds The default setting can be adjusted by service personnel as described in the N 550 service manual Procedure With the N 550 in the normal monitoring mode 1 Press the Alarm Silence button until XX SEC is displayed A Durations are OFF 30 60 90 and 120 seconds Note For steps 2 and 3 the Adjust Up and Adjust Down buttons RE must be pressed while pressing the Alarm Silence button N 550 29 Using the N 550 2 While pressing the Alarm Silence button press and hold the Adjust Up button to increase alarm silence duration to Off 30 60 90 or 120 seconds 3 While pressing the Alarm Silence button press and hold the Adjust Down button to decrease alarm silence duration to OFF 30 60 90 or 120 seconds Note Releasing the Adjust Up or Adjust Down button sets the alarm silence duration Disabling Audible Alarms Discussion Setting the alarm silence duration to OFF means that the
20. solution of 10 chlorine bleach in tap water Before attempting to clean an SpO sensor read the directions for use enclosed with the sensor Each sensor model has cleaning instructions specific to that sensor 86 Technical Information Description of Alarms The N 550 has three levels of audible alarms 1 High priority alarm A high pitched fast pulsating tone indicating loss of pulse with no patient motion 2 Medium priority alarm A medium pitched normal pulsating tone indicating an SpOz or pulse rate limit violation During a medium priority alarm the green display turns red and flashes with the patient parameter that violated the limit SpOz or Pulse Rate If the alarm is a SatSeconds alarm the SatSeconds indicator clock will flash 3 Low priority alarm A low pitched slow pulsating tone indicating a sensor disconnect low battery or N 550 failure During a low battery alarm the Low Battery indicator illuminates and the alarm tone sounds immediately even if the alarms are silenced or set to OFF N 550 87 Technical Information Factory Defaults 88 The N 550 is shipped with factory default settings Authorized technical personnel using the procedures described in the N 550 service manual can change default settings Table 5 Factory Default Settings Factory Parameter Range Default Setting SpO2 Upper Alarm Lower Alarm Limit 100 Limit plus 1 to 100 SpO2 Lower
21. the rear of the N 550 Pole mount bracket 70 Performance Considerations WARNING Pulse oximetry readings and pulse signals can be A affected by certain ambient environmental conditions sensor application errors and certain patient conditions See the appropriate sections of the manual for specific safety information Performance Verification The performance of the N 550 can be verified by following the procedures outlined in the Performance Verification section of the N 550 service manual Qualified service personnel should perform these procedures before using the N 550 for the first time in a clinical setting N 550 Performance Considerations N 550 Certain patient conditions can affect the measurements of the N 550 and cause the loss of the pulse signal Inaccurate measurements can be caused by e prolonged patient movement venous pulsations e intravascular dyes such as indocyanine green or methylene blue defibrillation 71 Performance Considerations Dysfunctional Hemoglobins Anemia Saturation Pulse rates Dysfunctional hemoglobins such as carboxyhemoglobin methemoglobin and sulphemoglobin are unable to carry oxygen SpO2 readings may appear normal however a patient may be hypoxic because less hemoglobin is available to carry oxygen Further assessment beyond pulse oximetry is recommended Anemia causes decreased arterial oxygen content Although SpO2 readings may ap
22. your local Nellcor representative for technical assistance Write down the numbers and have them available prior to requesting technical assistance 6 Ifthe N 550 detects an internal problem during the self test an alarm tone sounds and the N 550 displays an Error Code and the corresponding number See Troubleshooting on page 77 N 550 23 Using the N 550 Se K 7 Upon successful completion of the POST the N 550 sounds a one second tone indicating that the N 550 has passed the test WARNING If you do not hear the POST pass tone do not use the N 550 WARNING Ensure that the speaker is clear of any obstruction Failure to do so could result in an inaudible alarm tone 9 Note In addition to serving as the POST pass verification the POST pass tone also functions as an audible confirmation that the speaker is performing properly If the speaker does not function the alarm sounds cannot be heard Sensor Attached The Pulse Search indicator and the Sensor Off indicator light and the N 550 displays dashes in the SpOz and Pulse Rate displays while the N 550 is searching for a valid pulse 24 N 550 Using the N 550 1 Sensor Off 2 Pulse Search Indicator When a valid pulse is detected the N 550 enters the Monitoring Mode and displays patient parameters Look for movement of the blip bar and if the pulse beep volume is not 0 listen for pulse beeps to verify that displayed measurement values are
23. 0 bpm ADULT 0 SAT S TIME 96SpO2 PA Status 30 Sep 03 18 24 24 SD 30 Sep 03 18 24 26 SD 30 Sep 03 18 24 28 98 30 Sep 03 18 24 30 98 30 Sep 03 18 24 32 99 Figure 4 Real Time Data Printout Trend Data Printout The format of data displayed when a trend printout is requested is the same as the real time data The only differences are that TREND is displayed in the top row instead of the CRC XXXX software verification number and there is no Status column Readings are displayed in 4 second intervals The values on each row are an average for the 4 second period At the end of the printout an Output Complete line indicates that the transmission was successful If the Output Complete line is not present a corruption of the data may have been detected and the data should be ignored N 550 59 Printing N 550 VERSION 1 00 00 TREND SpO2 Limit 85 100 PR Limit 40 170 bpm ADULT 0 SAT S TIME SpO2 BPM PA 10 Nov 03 21 26 53 98 53 10 Nov 03 21 26 57 98 53 10 Nov 03 21 30 01 98 110 53 N 550 VERSION 1 00 00 TREND SpO2 Limit 80 100 PR Limit 40 170 bpm ADULT 0 SAT S TIME SpO2 BPM PA 10 Nov 03 21 30 05 98 53 10 Nov 03 21 30 09 95 51 10 Nov 03 21 30 13 93 50 10 Nov 03 21 30 17 91 49 10 Nov 03 21 30 21 85 47 10 Nov 03 21 30 25 80 42 10 Nov 03 21 30 29 78 41 10 Nov 03 21 30 33 78 41 Output Complete Figure 5 Trend Data Printout Once a trend printout has begun the N 550 mu
24. 550 2 Connect an SpO2 Sensor to the other end of the DOC 10 pulse oximetry cable 3 Place the SpOz Sensor on the patient or yourself Turn on the N 550 wn Press and hold the Adjust Up or Adjust Down button to increase or decrease the pulse beep tone volume S N 550 27 Using the N 550 Setting the Alarm Volume With the N 550 in the normal monitoring mode Press and hold the Alarm Silence button until the alarm volume ANY display appears pe mt Sea Ki 2 While continuing to press the Alarm Silence button press the Adjust Up button or Adjust Down button to increase or decrease GO the alarm volume Setting Alarm Silence Duration Discussion WARNING Do not silence an audible alarm or decrease its volume if patient safety could be compromised Alarms can be silenced for a preset period called alarm silence duration To view the current setting press and hold the Alarm Silence button until 30 SEC 60 SEC 120 SEC or OFF is displayed To adjust the settings press and hold the Alarm Silence button until 30 SEC 60 SEC 120 SEC or OFF is displayed Continue holding the 28 Using the N 550 Alarm Silence button and use the Adjust Up button or Adjust Down button to increase or decrease the value Possible values are 30 60 90 or 120 seconds or OFF The OFF selection is discussed under Disabling Audible Alarms on page 30 If the Alarm Silence button is pressed during the alarm
25. 601 1 2 1993 CAN CAS C22 2 No 601 1 UL 2601 1 ISO 10993 1 Type of protection Class I on AC power Internally powered on battery power Degree of protection Type BF Applied part Mode of operation Continuous N 550 resistant to liquid ingress IEC 60601 1 sub clause 44 6 for class IPX1 Drip Proof equipment Degree of Safety in presence of a flammable anaesthetic IEC 60601 1 Sub clause 37 5 Not suitable Applied sensor label to indicate Type BF applied part IEC 60601 1 Symbol 2 of Table DII of Appendix D Equipotential lug symbol to indicate a potential equalization conductor IEC 60601 1 Symbol 9 of Table DI of Appendix D Attention symbol consult accompanying documentation IEC 60601 1 Symbols 14 of Table DI of Appendix D External case made with non conductive plastic IEC 60601 1 sub clause 16 a No holes in case top IEC 60601 1 sub clause 16 b Rigid case IEC 60601 1 sub clause 21 a Case mechanically strong IEC 60601 1 sub clause 21 b 105 Specifications 106 Item Compliant With Case handle IEC 60601 1 sub clause 21 c N 550 resistant to rough handling IEC 60601 1 sub clause 21 6 N 550 resistant to liquid ingress due to spills Environmental IEC 60601 1 sub clause 44 3 as modified by EN 865 clause 4 IEC 60601 1 sub clause 44 5 Operation during physical shock IEC 60068 2 27
26. 67 Note The N 550 should complete the POST function within 12 seconds 1 Turn on the N 550 by pressing and holding the Power On Off button for more than one second 21 Using the N 550 2 The N 550 displays sounds Display Sound 5 in pulse rate left window one beep tone 5 in pulse rate center window one beep tone 0 in pulse rate right window one beep tone n in SpO2 left window none n in SpO2 center window none 3 The N 550 automatically starts the Power On Self Test POST which tests N 550 circuitry and functions CAUTION During POST immediately after power up confirm that all display segments and indicators light and the speaker sounds a 1 second pass tone 4 While performing POST the self test display appears for approximately 2 to 4 seconds During this time e All indicators illuminate e All segments of all numeric digits light and change from red to green 22 Using the N 550 e All segments of the Pulse Amplitude Display light All segments of the SatSeconds indicator light 5 Once the display test portion of POST is complete the N 550 software version is displayed for approximately 2 seconds Sco Kt Note The device version illustrated is only a sample The device version identifies the hardware configuration and the software revision Device version numbers are often needed when calling Nellcor s Technical Services Department 1 800 635 5267 or
27. Accessories e ien ett ei tii abuse et iria eap crate 68 germen 69 Visual Alarm Indicator eseseeeeeseees 69 Pole Mount Bracket ccccccsseeeeeseeeseeeseeenseesenensenes 70 Performance Considerations creer 71 Performance Verification cccceceescccecesseeeetenseseersneeseeteaes 71 N 550 Performance Considerations es 71 Dysfunctional Hemoglobins essssssssss 72 Anemia See a a NUMEN TII 72 SalbllatiOni enrera cere rdiet sert er ea do 72 Pulse rates sssesssseeeeseenereemneneennennnen nnn 72 Sensor Performance Considerations 72 N 550 iii Contents Operator S IIO 4 06 uade we ae rece eee RA dU Ra aon X V dr RE GA ean 75 TIOUDIBE BODIE uakaxadetnhauamendaERRR ER ER REqESAaE RE E Rad 77 Error GOd S oet i tree ten iG erbe 77 Corrective ACIIOn itte rete rese kel pP a bild Ide 78 EMI Electro magnetic Interference 81 Obtaining Technical Assistance eseessssssss 82 PONCE ou uadit 3299 3 8 808 2 3 0 ardeo o C DR CRCRCRC RC E EU aen aO RR 85 Returning the N 550 Liu ea uode asit inn etri ere Ere sid ruere des 85 SEVICE ecd tee chere ie rec detente 85 Periodic Safety Checks ccccsscseeceeeeeeeseneeeeeeeessessessneeeeees 86 CHI RP r 86 Technical Informall
28. Alarm 20 to Upper Alarm 85 Limit Limit minus 1 Pulse Rate Upper Lower Alarm Limit 170 bpm Alarm Limit plus 1 to 250 bpm Pulse Rate Lower 30 bpm to Upper 40 bpm Alarm Limit Alarm Limit minus 1 Alarm Silence On or Off On Reminder Alarm Silence Off 30 60 90 120 60 seconds Duration seconds Alarm Silence e Audible reminder Audible Restrictions i reminder e No audible reminder e Donot allow alarms off Alarm Sound Selector 1 2 3 1 Alarm Volume 1 to 10 4 Data Port Baud Rate 2400 9600 19200 19200 Data Port Protocol 1 2 1 ASCID Technical Information Table 5 Factory Default Settings Factory Parameter Range Default Setting Display 0 1 0 On In Sensor Trend Mode 0 1 2 0 Event SpO2 Language English English Pulse Beep Volume 0 to 10 4 RS 232 Nurse Call Normally high Normally low Priority normally low SatSeconds Off 10 25 50 100 Off Silence Alarms 0 1 1 Off SatSeconds Display When the N 550 SatSeconds technology detects an SpO2 value outside the alarm limit the SatSeconds indicator LEDs begin to light fill clockwise When the SpO2 value is within the set limits the SatSeconds indicator LEDs will extinguish counterclockwise When all of the SatSecond indicator LEDs are lit indicating that the SatSeconds setting has been reached an audible alarm sounds and the SatSeconds indicator LEDs flash As with traditional alarm management the audible alarm may be silenced by press
29. Net is for patients whose saturation levels frequently go below the limit but do not stay below the limit long enough for the SatSeconds setting to be reached When 3 or more limit violations occur in 60 seconds an alarm will sound even if the SatSeconds setting has not been reached Principles of Operation Oximetry Overview N 550 The N 550 uses pulse oximetry to measure functional oxygen saturation in the blood Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed such as a finger or toe The sensor contains a dual light source and a photo detector Bone tissue pigmentation and venous vessels normally absorb a constant amount of light over time The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations The ratio of light absorbed is translated into a measurement of functional oxygen saturation SpO2 Because a measurement of SpO2 is dependent upon light from the sensor excessive ambient light can interfere with this measurement Specific information about ambient conditions sensor application and patient conditions is contained throughout this manual Pulse oximetry is based on two principles that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse plethysmography A pulse oximeter
30. Operator s Manual D 09 E gt lt O oD w 5 am 00N RENES This ISM device complies with Canadian ICES 001 Cet appareil ISM est conforme la norme NMB 001 Canada Nellcor Puritan Bennett Inc is an affiliate of Tyco Healthcare Nellcor Oxiband Durasensor OxiCliq OxiBand Dura Y MAX FAST SatSeconds PediCheck Oxismart and OxiMax are trademarks of Nellcor Puritan Bennett Inc To obtain information about a warranty if any contact Nellcor s Technical Services Department or your local representative Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett 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 Re 35 122 4 802 486 4 869 254 4 928 692 4 934 372 5 078 136 5 351 685 5 368 026 5 485 847 5 533 507 5 662 106 5 853 364 and 6 083 172 Contents COMENS ee ee ee er ene aE eee ee ree ee eT pee mee re en i FR MES ons ck heer dGane SNE EE E d dd WE RE RAE A Rd E d ES RR d VR wew es V Tables ous daa d rr vi Salely Informati n cides ctu ra daAWARARRARRRRGRRERREEPAAE AE ERAT 1 Warnings pieren n io i tos dedii pastu diateedt cuius 1 BUTS ie uidi Pon sab odoris medo aud ced coches that ach Donius 2 Plc EEUU EET 3 EDGE BON 3a Xdcedcari c Es dad AA A Ide ae dowd E
31. UER Crees wears 5 Intended Use for the N 550 nece hens eene 5 Description of Controls Indicators and Symbols 7 Identification of Front Panel Buttons and Symbols 7 Identification of Rear Panel Components 8 N 550 Symbols t 8 Description of Controls seseseen 9 Description of Displays and Indicators 11 Description of Audible Indicators sessesssss 13 bU UR Ihe PB sid ka d A Ses RERO RAO OC ACAG ROROR OR RR d e ded 15 List of Components 1 tn rx eth ii secon X FEE en oS 16 Connecting the N 550 to AC Power ssesseeees 17 Connecting a Sensor to the N 550 essssss 17 Hallory DDSPAUOR iua nau wach ce cede d o RR ERROR OCA Urn e RD d RR 19 Operating the N 550 on Battery Power ssss 19 Low Battery Indicator 3 redis ker ento heit tege ipd c saeua unes 20 sind Th N OOU assured arie x RR ER ES dE CR n RrRR WARE es ce a ur CR wens 21 Turning on the N 550 irure iiii Eno teii oet Sc Rei oiu ans 21 Discussion ssssssse mnes 21 Procedure iei iae xy x hia ed a en ava eA en eas 21 Sensor Attached 1st iter ebbe tin tides 24 No Sensor Attached sssseessssse 26 Sensor Message 2 eut co Ga ELI Deum 26 N 550 Contents Setting the Pulse Beep Volume
32. art number 1 747579 2 and compatible pins AMP part number 66570 2 The cable should be no more than 25 feet 7 6 meters in length The external ITE Information Technology Equipment device must be certified to UL 1950 or IEC 60950 47 Using the Data Port The cable used must have a braided shield providing 100 coverage such as a Belden cable Belden part number 9609 or equivalent The shield must have a 360 degree connection to the metal shell on the N 550 s DB 15 connector and to the connector on the PC or serial printer Do not create sharp bends in the cable as this may tear or break the shielding No hardware flow control is used However in the ASCII mode XON XOFF flow control is supported Data Port Pinouts 48 TXD represents the Transmit Data line and RXD is the Receive Data line The pinouts for the data port are listed in Table 1 Table 1 Data Port Pinouts Pin Signal Name 1 RXD RS 422 positive input 2 RXD RS 232 input 3 TXD RS 232 output 4 TXD RS 422 positive output 5 Signal Ground isolated from Earth Ground 6 NC No connection 7 Normally Open relay closure nurse call normally open 8 Normally Closed relay closure nurse call normally closed 9 RXD RS 422 negative output 10 Signal Ground isolated from earth ground 11 Nurse Call RS 232 level output Data Port Setup Using the Data Port Table 1 Data Port Pinouts Pin Signal Name 12
33. ator and the pulse search indicator are simultaneously lit it is an indication that the artifact is significant and or has been persistent The Pulse Search Indicator Lights continuously prior to initial acquisition of a pulse signal and during prolonged and challenging monitoring conditions It flashes during a loss of pulse signal The Sensor Off Indicator is lit when either the sensor is invalid or no longer on the patient s finger It usually indicates that the sensor is not on the patient The Sensor Message Indicator Lights when the N 550 cannot determine an SpO2 level or a pulse rate The Sensor Message recommendations for improving the signal are Reposition sensor e Check or change adhesive wrap Choose alternate site e Warm site e Cover sensor e Use forehead nasal or ear sensor adult patients only e Use OxiMax adhesive sensor e Secure cable e Secure with headband Max Fas7 e Remove nail polish e Loosen sensor too tight e Isolate external interference electrosurgical device cell phone e Clean site MAX R Description of Controls Indicators and Symbols The Data In Sensor Indicator The indicator blinks for approximately one minute when initially connected to the N 550 to indicate that the attached OxiMAx sensor contains a patient sensor event record The indicator lights continuously to indicate that the attached sensor memory is full The indicator does not light when there is no data in th
34. ause of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in health care environments for example electrosurgical units cellular phones mobile two way radios electrical appliances and high definition television it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device 81 Troubleshooting The N 550 is designed for use in environments in which the pulse can be obscured by electromagnetic interference During such interference measurements may seem inappropriate or the N 550 may not seem to operate correctly Disruption may be evidenced by erratic readings cessation of operation or other incorrect functioning If this occurs the site of use should be surveyed to determine the source of this disruption and the following actions taken to eliminate the source e Turn equipment in the vicinity off and on to isolate the offending equipment e Reorient or relocate the interfering equipment Increase the separation between the interfering equipment and this equipment The N 550 generates uses and can radiate radio frequency energy and if not installed and used in accordance with these instructions may cause harmful interference with other devices in the vicinity If assistance is required contact Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor re
35. ble for use at any time The N 550 cannot operate with a dead battery even when plugged in Before attempting to turn on an N 550 with a depleted battery first plug the N 550 into an AC outlet to allow the battery to charge for a few minutes The N 550 may then be powered on To charge a low or dead battery connect the N 550 to AC power A full charge of a dead battery takes 11 hours while the N 550 is turned off or 12 hours while the N 550 is on When all of the following conditions are present for 15 minutes the N 550 will automatically shut down e N 550is running on battery power e No buttons have been pressed e No pulse has been detected for example when no patient is connected to the sensor or the sensor is disconnected 19 Battery Operation e No alarms are present other than low battery or a non correctable error Low Battery Indicator 20 e E The Low Battery Indicator lights and a low priority alarm begins to o e c sound when 15 minutes but not more than 20 minutes of monitoring time remain on the existing battery charge This alarm cannot be silenced while running on battery power Connecting the N 550 to AC power will silence the alarm If the N 550 is not connected to AC power within approximately 15 minutes the N 550 will shut off Note As the battery is used and recharged over a period of time the amount of time between the onset of the low battery alarm and the N 550 shut off may become
36. bs single pateint use adult nasal OXIMAX OxiCliq nonadhesive sensor OxiCliq A 230 kg 66 lbs single patient use adult reusable cable OXIMAX OxiCliq nonadhesive sensor OxiCliq N lt 3 kg or gt 40 kg single patient use neonatal adult 6 6 lbs or gt 88 Ibs reusable cable OXIMAX OxiCliq nonadhesive sensor OxiCliq P 10 to 50 kg 22 to single patient use pediatric reusable 110 Ibs cable OXIMAX OxiCliq nonadhesive sensor OxiClig I 3 to 20 kg 6 6 to single patient use infant reusable 44 1 lbs cable OXIMAX Durasensor finger clip sensor DS 100A gt 40 kg 88 Ibs reusable adult OXIMAx Oxiband sensor reusable OXI A N lt 3 kg or 240 kg neonatal adult 6 6 lbs or gt 88 Ibs OXIMAX Oxiband sensor reusable OXI P I 3 kg to 40 kg pediatric infant 6 6 Ibs to 88 Ibs 67 Sensors and Accessories Table 2 Nellcor Oximetry Sensor Models and Patient Weights Patient Size OxiMAx Sensor Model zgreater than zless than OXIMAX Dura Y multisite sensor D YS gt l kg 22 2 lbs reusable For use with the Dura Y sensor Ear clip Reusable nonsterile D YSE 230 kg 66 Ibs Pedi Check pediatric spot check i T 3 kg to 40 k clip Reusable nonsterile D YSPD 6 Pies io E Ibs Biocompatibility Testing Biocompatibility testing has been conducted on Nellcor sensors in compliance with ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing The sensors have passed the reco
37. ccuracy Grid posted on the Internet at http www mallinckrodt com respiratory resp Serv_Supp ProductManuals html Follow the sensor sterilization procedures in the applicable sensor directions for use DFU Table 2 Nellcor Oximetry Sensor Models and Patient Weights Patient Size Ox Max Sensor Model gt greater than lt less than OXIMAX MAX FAST adhesive forehead MAX FAST gt 10 kg 22 lbs sensor single patient use OXIMAX Softcare nonadhesive sensor SC PR single patient use preteen infant lt 1 5 kg 3 3 Ibs OXIMAX Softcare nonadhesive sensor SC NEO single patient use adult 1 5 to 5 kg 3 3 to 11 Ibs OXIMAX Softcare nonadhesive sensor SC A gt 40 kg 88 Ibs single patient use preteen infant OXIMAX adhesive sensor MAX A gt 30 kg 66 lbs single pateint use adult OXIMAX adhesive sensor MAX AL gt 30 kg 66 Ibs single pateint use adult longer cable 36 inches 91 44 cm OxiMAx adhesive sensor MAX N lt 3 kg or gt 40 kg single pateint use neonatal adult 6 6 lbs or gt 88 lbs Sensors and Accessories Table 2 Nellcor Oximetry Sensor Models and Patient Weights Patient Size OxiMax Sensor Model gt greater than lt less than OXIMAx adhesive sensor MAX P 10 to 50 kg 22 to single pateint use pediatric 110 lbs OXIMAx adhesive sensor MAX I 3 to 20 kg 6 6 to single pateint use infant 44 1 Ibs OXIMAX adhesive sensor MAX R gt 50 kg 110 I
38. current and accurate When a sensor is connected to the N 550 and is not connected to a patient the display reads dashes and the N 550 remains in the Pulse Search mode ra mt t g 9 9h I 2sESTD 25 Using the N 550 No Sensor Attached x f es ca ww I o Ld gt gt N When the sensor is not attached the N 550 displays dashes and the Pulse Search indicator is not lit indicating that the N 550 failed to detect a sensor Sensor Message 26 The Sensor Message feature is an indication that the sensor position or site needs to be considered The Sensor Message indicator lights when the N 550 cannot determine an SpO level or a pulse rate The e w Sensor Message recommendations for improving the signal are Reposition sensor Check or change adhesive wrap Choose alternate site Warm site Cover sensor Use forehead nasal or ear sensor adult patients only Use OxiMAx adhesive sensor Secure cable Secure with headband Max Fasr Remove nail polish Loosen sensor too tight Using the N 550 e Isolate external interference electrosurgical device cell phone e Clean site MAX R Setting the Pulse Beep Volume nri con 1 SpO2 Sensor Port WARNING Use only Nellcor approved sensors and sensor A cables 1 Connect a DOC 10 pulse oximetry cable to the SpO2 Sensor Port 1 on the front of the N
39. d into a properly grounded AC outlet ec 3 Verify that the AC POWER INDICATOR is lit Connecting a Sensor to the N 550 N 550 Use of another sensor cable will have an adverse effect on performance Do not attach any cable that is intended for computer use to the sensor port Do not connect any device other than a Nellcor approved sensor to the sensor connector WARNING Use only the DOC 10 pulse oximetry cable with the N 550 17 Setting up the N 550 1 SpO2 Sensor Port 1 Connect a DOC 10 pulse oximetry cable to the SpO2 Sensor Port 1 on the front of the N 550 2 Connect an SpO2 Sensor to the other end of the DOC 10 pulse oximetry cable Plug the sensor connector firmly into the DOC 10 pulse oximetry cable 18 Battery Operation A WARNING Dispose of an old battery by following local guidelines for disposal of lead acid batteries Operating the N 550 on Battery Power N 550 Q The N 550 has an internal battery that may be used to power the N 550 during transport or when AC power is not available A new fully charged battery will provide at least 1 5 to 2 hours of monitoring time under the following conditions no audible alarms sound and no serial output devices are attached Note Whenever the N 550 is connected to AC power the battery is being charged Therefore it is recommended that the N 550 remain connected to AC power when not in use This will make a fully charged battery availa
40. 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 voltage light emitting diodes LED in the oximetry sensor serve as light sources a photo diode serves as the photo detector 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 N 550 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 93 Principles of Operation During diastole blood volume and light absorption reach their lowest point The N 550 bases its SpO2 measurements on the difference between maximum and minimum absorption 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 There are various matrixes within the OxiMax algorithm Some are used to assess the severity of conditions presented to the N 550 in measuring SpO2 and pulse rate These individual matrixes or combinations of these matrixes are used to drive the LED indicators on the N 550 front panel During challenging measurement conditions which could be caused by low perfusio
41. e sensor even though a valid sensor is connected to the N 550 The SatSeconds Indicator Fills in clockwise as the SatSeconds alarm management approaches the SatSeconds alarm limit threshold All segments of the SatSeconds indicator flash during a SatSeconds alarm When a SatSeconds setting other than OFF is selected the green LED at the top of the SatSeconds indicator will light The green LED at the 12 o clock position indicates that SatSeconds alarm management is engaged Description of Audible Indicators N 550 Following are descriptions of N 550 audible indicators Power On Self Test A 1 second tone indicating that the N 550 Pass has been turned on and has successfully completed the power on self test Valid Button Press A short medium pitched tone indicating that an appropriate button has been pressed Invalid Button Press A short low pitched tone indicating that a button has been pressed that is not appropriate for the current state of the N 550 High Priority Alarm A high pitched fast pulsating tone indicating loss of pulse with no patient motion Medium Priority A medium pitched normal pulsating tone Alarm indicating an SpO2 or pulse rate limit violation 13 Description of Controls Indicators and Symbols Low Priority Alarm A low pitched slow pulsating tone indicating a sensor disconnect low battery or N 550 failure Alarm Silence Three beeps that sound approximately Reminder e
42. ected and observe all warnings and cautions presented in the directions for use accompanying the sensor Clean and remove any substances such as nail polish from the application site Periodically check to ensure that the sensor remains properly positioned on the patient application or inappropriate duration of use of an SpO sensor WARNING Tissue damage can be caused by incorrect Inspect the sensor site as directed in the sensor directions for use N 550 73 Performance Considerations 74 e High ambient light sources such as surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight can interfere with the performance of an SpO2 sensor To prevent interference from ambient light ensure that the sensor is properly applied and cover the sensor site with opaque material Caution Failure to cover the sensor site with opaque material in high ambient light conditions may result in inaccurate measurements If patient movement presents a problem try one or more of the following remedies to correct the problem e verify that the sensor is properly and securely applied e move the sensor to a less active site e use an adhesive sensor that tolerates some patient motion e use a new sensor with fresh adhesive backing If poor perfusion affects performance consider using the OXIMAX MAX R sensor it obtains measurements from the nasal septal anterior et
43. he display If alarm limits have been changed from their power on defaults a decimal point is displayed after the SpO2 value 100 The Pulse Rate Display Shows the pulse rate in beats per minute It flashes zeros during loss of pulse alarms and flashes the beats per minute value in red when the pulse rate is outside of the alarm limit During pulse search the N 550 continues to update the display Pulse rates outside of the pulse rate range 20 to 250 bpm are displayed as the closest value within the range If alarm limits have been changed from their power on defaults a decimal point is displayed after the pulse rate value 112 The AC Power Indicator Lights continuously when the N 550 is connected to AC power It also indicates that the battery is charging It is off when the N 550 is being powered by its internal battery The Low Battery Indicator Lights continuously to indicate that 15 or fewer minutes of battery capacity remain The Low Battery indicator flashes when the battery is critically low 11 Description of Controls Indicators and Symbols 12 The Alarm Silence Indicator Lights continuously when an audible alarm has been silenced It flashes when the alarm silence duration has been set to OFF The Motion Indicator Lights continuously whenever the OxiMAx algorithm detects the presence of artifact independent of its severity or the impact on the SpO2 or pulse rate values Whenever the motion indic
44. hmoid artery an artery supplied by the internal carotid artery This sensor may obtain measurements when peripheral perfusion is relatively poor Operator s Menu N 550 This operator s menu provides a quick reference to the functions on the N 550 The functions that are Bold are the default settings Table 3 Operator s Menu Sub Reference Menu Function Menu Paragraph 1 Trend print tabular Trend Data Printout N 550 trend only on page 59 2 Trend clear Clearing Trend Information on page 40 3 Language English 4 Baud rate Setting the Data Port Baud Rate on page 37 24 2400 baud 96 9600 baud 192 19200 baud 5 Data Port Protocol Setting the Data Port Protocol on page 39 1 ASCII 2 External equipment Refer to the external communications equipment manuals for the interfacing instructions 75 Blank Page Troubleshooting A A e Error Codes N 550 WARNING If you are uncertain about the accuracy of any measurement check the patient s vital signs by alternate means then make sure the N 550 is functioning correctly WARNING The cover should be removed only by qualified service personnel There are no user serviceable parts inside CAUTION Do not spray pour or spill any liquid on the N 550 its accessories connectors switches or openings in the chassis When the N 550 detects an error condition it may display the letters EEE f
45. indicator 12 N N 550 returning 85 Nurse Call Relay Contacts 54 Using 53 O Operating relative humidity 102 temperature 102 Operator s menu 75 OXIMAX technology 5 Oximetry overview 93 P Patient motion 64 Patient settings verifying 31 Performance considerations 71 Performance verification 71 110 PH 64 PL 64 Print trend 44 Printing trend information 57 PS 64 Pulse amplitude indicator 11 Pulse beep volume setting 27 Pulse rate display 11 Pulse rate high limit alarm 64 Pulse rate low limit alarm 64 Pulse search 64 Pulse search indicator 12 R Rear panel 8 Returning the N 550 85 S Safety checks 86 Safety information 1 SatSeconds duration setting 36 Saturation high limit alarm 64 Saturation low limit alarm 64 Saturation calculated 95 Saturation fractional 95 Saturation measured 95 SD 64 Selecting a sensor 65 Sen Err 77 Sensor disconnect 64 Sensor messages indicator 13 Sensor off 64 Sensor off indicator 12 Sensor selection 66 Sensor selecting 65 Service 85 Setting pulse beep volume 27 SH 64 Shut down automatic 19 SL 64 SO 64 Specifications 97 battery 101 compliance 105 electrical 101 electrical instrument 101 environmental 102 performance 97 physical 104 Storage relative humidity 103 N 550 Index temperature 102 Symbols 8 T Technical assistance 82 Transport relative humidity 103 temperature 102 Trend clear 44 Trend data operation 43 Trend pr
46. ing the N 550 must be turned off and then turned back on When connecting the N 550 to a printer or computer verify proper operation before clinical use Both the N 550 and the printer or PC must be connected to a grounded AC outlet Any printer or computer connected to the N 550 s data port must be certified according to IEC Standard 60950 All combinations of equipment must be in compliance with IEC Standard 60601 1 1 systems requirements Anyone who connects a printer or PC to the data output port configures a medical system and is therefore responsible that the system complies with the requirements of system standard IEC Standard 60601 1 1 and the electromagnetic compatibility system standard IEC Standard 60601 1 2 57 Printing 1 Data Port Connector 1 Connect the serial printer to the N 550 s Data Port connector 1 2 Turn on the printer 3 Connect the N 550 to an AC outlet 4 Turnon the N 550 The printer will start printing real time trend data or the PC will start displaying real time data at a rate of one line every 2 seconds 58 Printing N 550 VERSION 1 00 00 CRC XXXX SpO2 Limit 85 100 PR Limit 40 170 bpm ADULT 0 SAT S TIME SpO2 BPM PA Status 30 Sep 03 16 00 00 100 120 220 30 Sep 03 16 00 02 100 124 220 30 Sep 03 16 00 04 100 170 220 30 Sep 03 16 00 06 120 220 30 Sep 03 18 00 43 Le e SD 30 Sep 03 18 00 45 sD N 550 VERSION 1 00 00 CRC XXXX SpO2 Limit 80 100 PR Limit 40 17
47. ing the Alarm Silence button green LED at the top of the SatSeconds indicator will light The 3 Note When a SatSeconds setting other than OFF is selected the green LED indicates that SatSeconds have been engaged N 550 89 Technical Information Describing SatSeconds 90 With traditional alarm management upper and lower alarm limits are set for monitoring oxygen saturation During monitoring as soon as an alarm limit is violated by as little as one percentage point an audible alarm immediately sounds When the SpOz2 level fluctuates near an alarm limit the alarm sounds each time the limit is violated Such frequent alarms can be distracting The N 550 utilizes Nellcor SatSeconds alarm management With the SatSeconds technique upper and lower alarm limits are set in the same way as traditional alarm management However the clinician also sets a SatSeconds limit that allows monitoring of SpO2 below the selected lower alarm limit and above the selected upper alarm limit for a period of time before an audible alarm sounds The SatSeconds limit controls the time that the SpOz level may fall below the alarm limit before an audible alarm sounds The method of calculation is as follows The number of percentage points that the SpO2z falls outside the alarm limit is multiplied by the number of seconds that the SpOz level remains outside that limit This can be stated as an equation Points x Seconds SatSeconds Where P
48. int 44 111 Blank Page Blank Page NELLCOR Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton CA 94588 U S A Telephone Toll Free 1 800 563 5267 Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS UK 2003 Nellcor Puritan Bennett Inc All rights reserved Rx ONLY CE 0123 067856B 1103 tyco Healthcare
49. justable alarm volume Pitch 30 Hz 932 Hz Pulse width 20 msec Nellcor 255 msec IAW IEC 60601 1 8 120 msec IAW EN 475 150 msec Pulse repetition interval Nellcor 320 20 msec double burst msec IAW IEC 60601 1 8 6940 msec IAW EN 475 7500 msec Repetitions Continually Invalid Button Press Volume level Not changeable Pitch 30 Hz 180 Hz Pulse width 20 msec 70 msec Pulse repetition interval N A 20 msec double burst Repetitions 1 Low Priority Alarm Volume level Adjustable alarm volume Pitch 30 Hz 500 Hz Pulse width 20 msec 200 msec Pulse repetition interval 15000 msec 20 msec double burst Repetitions Continually 99 Specifications Table 6 Tone Definition Audible Indicator Parameter Value Medium Priority Volume level Adjustable alarm Alarm volume Pitch 30 Hz 752 Hz Pulse width 20 msec Nellcor N A IAW IEC 60601 1 8 160 msec IAW EN 475 200 msec Pulse repetition interval Nellcor N A 20 msec double burst IAW IEC 60601 1 8 7600 msec IAW EN 475 20000 msec Repetitions Continually POST Pass Volume level Not changeable Pitch 30 Hz 784 Hz Pulse width 20 msec 1000 msec Pulse repetition interval N A 20 msec double burst Repetitions 1 Pulse Beep Volume level Adjustable Pitch
50. l for the procedure Pins 7 and 15 provide a relay that closes when an alarm is sounding on the N 550 Pins 8 and 15 provide a relay that opens when an alarm is sounding Pin 15 is a common lead for both relays Note When the relay is closed there is approximately 27 ohms of resistance Setting Nurse Call RS 232 Polarity The nurse call polarity can be set to a high signal on an N 550 alarm condition or a low signal on an N 550 alarm condition Refer to the N 550 service manual for setting the Nurse Call RS 232 polarity Setting Nurse Call Relays Normally Open Closed Data port pins 7 and 15 provide a relay that closes nominally 27 ohms when an alarm is sounding on the N 550 Pins 8 and 15 54 Using the Data Port provide a relay that opens when an alarm is sounding Pin 15 is a common lead for both relays The relay operates whether the N 550 is operating on AC power or battery N 550 55 Blank Page Printing Printing N 550 Real Time Data N 550 Real time data is continuously sent to the data port on the back of the N 550 Patient data can be obtained through the data port by connecting to a computer or serial printer When a real time printout or display is being transmitted to a printer or computer a new line is printed displayed every 2 seconds Column headings are printed displayed every 25 lines or if one of the values in the column heading is changed Note If the data output stops transmitt
51. mmended biocompatibility testing and are therefore in compliance with ISO 10993 1 Optional Accessories Several optional accessories are offered with the N 550 Contact Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative for information about these accessories e Foot switch e Visual alarm indicator e Pole mount bracket 68 Sensors and Accessories Accessories for the N 550 are listed on the Internet at http www mallinckrodt com respiratory resp Serv_Supp Apartweb main PartAcceMenu html Foot Switch An optional foot switch is available for the N 550 The foot switch may be used to silence N 550 alarms The foot switch is connected to the rear of the N 550 CAUTION The N 550 must be turned off when connecting or disconnecting the foot switch 1 Foot switch connector Visual Alarm Indicator An optional visual alarm indicator is available for the N 550 The visual alarm indicator mounted on the top of the N 550 with double back tape The visual alarm indicator is connected to the rear of the N 550 CAUTION The N 550 must be turned off when connecting or disconnecting the visual alarm indicator N 550 69 Sensors and Accessories 1 Visual alarm indicator Pole Mount Bracket An optional pole mount bracket is available for the N 550 The pole mount bracket may be used to attach the N 550 to an IV pole The pole mount bracket is attached to
52. n motion external interference like ambient light or a combination of these the OxiMAx algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate If the resulting dynamic averaging time exceeds 20 seconds the pulse search indicator is lit solid and SpO2 and pulse rate will continue to be updated every second As these conditions become even more challenging the amount of data required continues to extend If the dynamic averaging time reaches 40 seconds the pulse search indicator begins flashing the SpO2 and pulse rate displays flash zero indicating a loss of pulse condition Automatic Calibration 94 Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies an oximeter must know the mean wavelength of the sensor s red LED to accurately measure SpO2 During monitoring the N 550 s software selects coefficients that are appropriate for the wavelength of that individual sensor s red LED these coefficients are then used to determine SpO2 Additionally to compensate for differences in tissue thickness the light intensity of the sensor s LEDs is adjusted automatically Principles of Operation Functional versus Fractional Saturation This N 550 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
53. n page 37 The baud rate selections are e 24 2 400 baud rate 44 N 550 Trend e 96 9 600 baud rate e 192 default 19 200 baud rate 5 Data Port Printout Selections are as follows Option 1 Printout in ASCII characters Option 2 External equipment communications Refer to the external equipment manual for the interfacing instructions N 550 45 Blank Page Using the Data Port Overview Patient data can be obtained through the data port on the back of the N 550 by connecting it to an attached PC or serial printer When connecting the N 550 to a printer or PC verify proper operation before clinical use Both the N 550 and the printer or PC must be connected to a grounded AC outlet The N 550 protocol setting must be ASCII Any printer or PC connected to the N 550 s data port must be certified according to IEC Standard 60950 All combinations of equipment must be in compliance with IEC Standard 60601 1 1 systems requirements Anyone who connects a printer or PC to the data output port configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC Standard 60601 1 1 and the electromagnetic compatibility system standard IEC Standard 60601 1 2 Connecting to the Data Port N 550 The N 550 data port may be connected to the printer or PC by using a cable terminated with an AMP connector AMP part number 747538 1 ferrule AMP p
54. ndex Symbols 96SpO2 display 11 A AC power indicator 11 Adjust down button 10 Adjust up button 10 Alarm limits setting 34 Alarm off 63 Alarm priorities 87 Alarm silence 64 Alarm silence button 10 Alarm silence duration setting 28 Alarm silence indicator 12 Alarm volume setting 28 Altitude 102 103 Anemia 72 AO 63 AS 64 Audible indicators 13 Audio alarms disabling 30 Automatic calibration 94 Automatic shut down 19 B Barametric pressure 102 103 Battery charging 19 Battery disposal 19 Battery use 19 Baud rate 44 Blipbar 11 C Calculated saturation 95 N 550 Calibration automatic 94 Cleaning 86 Components list of 16 Connecting a sensor 17 Connecting to the data port 47 Corrective action 78 D Data port pinouts 48 Data port printout Option 1 45 Data port printout Option 2 45 Data port connecting to 47 Decimal point 34 Default factory 88 Disinfecting 86 Disposal battery 19 Dysfunctional hemoglobins 72 E Electromagnetic interference 81 EMI 81 Error codes 77 F Factory defaults 88 Fractional saturation 95 Front panel 7 Functional saturation 95 Functional versus fractional saturation 95 H Hospital type environments 5 109 Index L LB 64 LM 64 Loss of pulse 64 Loss of pulse with motion 64 Low battery 64 Low battery indicator 11 LP 64 M Measured saturation 95 MO 64 Monitor accuracy and motion tolerance 97 measurement range 97 Motion
55. ngth range of the light emitted are near 660 nm and 890 nm Environmental Conditions Operation Temperature 10 C to 45 C 50 F to 113 F Altitude 390 m to 3 012 m 1 254 ft to 9 882 ft Barometric Pressure 70 kPa to 106 kPa 20 6 in Hg to 31 3 in Hg Relative Humidity 10 to 95 non condensing to be compliant with IEC 60601 1 sub clause 44 5 Transport and Storage not in shipping container Temperature 20 C to 60 C 4 F to 140 F 390 m to 5 574 m 1 254 ft to 18 288 ft Altitude 102 N 550 Specifications Transport and Storage not in shipping container Barometric Pressure 50 kPa to 106 kPa 14 7 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing Transport and Storage in shipping container Temperature 20 C to 70 C 4 F to 158 F Altitude 390 m to 5 574 m Barometric Pressure 1 254 ft to 18 288 ft 50 kPa to 106 kPa 14 7 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing Ox1Max Sensor Power Dissipation OxiMAx Sensor Dissipation OXIMAX MAX FAST adhesive forehead sensor single 52 5 mW patient use OXIMAX Softcare nonadhesive sensor single patient 52 5 mW use preteen infant OxiMAx Softcare nonadhesive sensor single patient 52 5 mW use adult OXIMAX Softcare nonadhesive sensor single patient 52 5 mW use preteen infant OXIMAX adhesive
56. oints SpO2 percentage points outside of the limit Seconds number of seconds that SpO2 remains at that point outside of the limit The alarm response time assuming a SatSeconds limit set at 50 and a lower alarm limit set at 90 is described and illustrated below Technical Information In this example the SpOz level drops to 88 2 points and remains there for a period of 2 seconds 2 points x 2 seconds 4 The SpO2 then drops to 86 for 3 seconds and then to 84 for 6 seconds The resulting SatSeconds are SpO2 Seconds SatSeconds 2x 2 4 4x 3 12 6x 6 36 Total SatSeconds 52 After approximately 10 9 seconds the SatSeconds alarm will sound because 50 SatSeconds will have been exceeded See arrow 1 in Figure 6 90 88 SpO2 86 84 50 Second SatSeconds Alarm Point 0123 45 6 7 8 9 10 11 SECONDS Figure 6 Alarm Response with SatSeconds N 550 91 Technical Information Saturation levels may fluctuate rather than remaining steady for a period of several seconds Often SpO2z levels may fluctuate above and below the alarm limit reentering the non alarm range several times During such fluctuation the N 550 integrates the number of SpOz points both positive and negative until either the SatSeconds limit SatSeconds setting is reached or the SpO2 level returns within a normal range and remains there SatSeconds Safety Net 92 The SatSeconds Safety
57. ol iussa ko ORE CROR ORA RR CR ICH E c 87 Description of Alarms uisoccacipugsi ieu itededa e acaanineeddetes riot 87 Factory aU i d quem LT 88 SatSeconds Display M Mc n 89 Describing SatSeconds cssseccceceeeesesseeeeeeeeeeeeseesnsaeees 90 SatSeconds Safety Net nennen 92 Principles of Operation cere wckec rau rh REIR yuan 93 Oximetry OVEIVIEW saccsiissccuiisist essc teta qe k raqutaaaetea n tih tae 93 Automatic Calibration eeeeeee 94 Functional versus Fractional Saturation 95 Measured versus Calculated Saturation 95 SDOUIDONUDNS LaadeuadAEEARSASARERCARARRRRATRRGRRA Y A RE RR RRAA X AE 97 Performance eet e bootie nets 97 Electrical eeeesssesssssseeeeeeenennennnnnnne nnne 101 Environmental Conditions eeeee 102 Physical Characteristics rrr oia 104 oum o V nnne enn ene 105 pii EBERT ES TNT TET t ees 109 Figures N 550 Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Contents Front Panel Buttons and Symbols 7 Rear Panel Symbols eet rico ttn 8 Data Port Pin Layout eeen 49 Real Time Data Printout ccccccceeceeteeeteees 59 Trend Data Printout sess 60 Alarm Response with SatSeconds 91 Oxyhemoglobin Dissociation Curve 96 Contents Tables
58. ollowed by an error code Sea f When an error code is displayed turn the N 550 off wait 10 seconds and turn the N 550 on If the error code is listed in Table 4 follow the action s listed If the action does not correct the error condition notify service personnel If the error code is not listed in Table 4 notify service personnel When the N 550 detects a defective sensor connected to the N 550 the N 550 displays an error code of Sen Err The sensor should be replaced and the N 550 power should be recycled 77 Troubleshooting et E o hj Table 4 Error Codes Error Code Action 513 1 Charge battery 2 Notify service personnel 514 1 Restart the N 550 2 Notify service personnel 525 1 Restart the N 550 2 Notify service personnel 526 1 Restart the N 550 2 Notify service personnel 528 1 Restart the N 550 2 Notify service personnel Corrective Action If you experience a problem while using the N 550 and are unable to correct it contact Nellcor s Technical Services Department or your local Nellcor representative The N 550 service manual which is for use by qualified service personnel provides additional troubleshooting information Following is a list of possible problems and suggestions for correcting them 78 N 550 Troubleshooting There is no response to the Power On Off button
59. or e Excessive patient motion may be preventing the N 550 from tracking the pulse Keep the patient still if possible Verify that the sensor is securely applied and replace it if necessary Change the sensor site Use a type of sensor that tolerates more patient movement for example an adhesive sensor e The sensor may be too tight there may be excessive ambient light or the sensor may be on an extremity with a blood pressure cuff arterial catheter or intravascular line Reposition the sensor as necessary e Excessive environmental motion or electromagnetic interference may be preventing the N 550 from tracking the pulse Remove the source of interference or try to stabilize the environment or do both The Pulse Search indicator lights after successful measurements have been made Check the patient e Perfusion may be too low for the N 550 to track the pulse Test the N 550 on someone else Change the sensor site Try another type of sensor Refer to Sensor Performance Considerations on page 72 e Prolonged patient motion may be preventing the N 550 from tracking the pulse Verify that the sensor is securely applied and replace it if necessary Change the sensor site Use a type of sensor that tolerates more patient movement for example an adhesive sensor e The sensor may be too tight there may be excessive ambient light or the sensor may be on an extremity with a blood pressure cuff arterial catheter or intra
60. pear normal an anemic patient may be hypoxic Correcting anemia can improve arterial oxygen content The pulse oximeter may fail to provide an SpO2 if hemoglobin levels fall below 5 gm dl The N 550 will only measure saturation levels between 1 and 100 The N 550 will only measure pulse rates between 20 and 250 beats per minute Detected pulse rates outside the range of 20 to 250 beats per minute are displayed as the closest value within the range Sensor Performance Considerations 72 WARNING Pulse oximetry readings and pulse signal can be affected by certain ambient conditions sensor application errors and certain patient conditions Performance Considerations Inaccurate measurements can be caused by incorrect application of the sensor e placement of the sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line ambient light prolonged patient movement Loss of pulse signal can occur for the following reasons e the sensor is applied too tightly e ablood pressure cuff is inflated on the same extremity as the one with the sensor attached e there is arterial occlusion proximal to the sensor Use only Nellcor sensors and sensor cables than those specified may result in increased emission and or decreased immunity and inaccurate readings of the N 550 pulse oximeter WARNING The use of accessories sensors and cables other Select an appropriate sensor apply it as dir
61. presentative Obtaining Technical Assistance 82 For technical information and assistance or to order parts or a service manual contact Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative The service manual includes block diagrams and a parts list required by qualified personnel when servicing the N 550 When calling Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative you may be asked to tell the representative the software version number of your N 550 The device version appears in the N 550 display each time the N 550 successfully completes the power on self test Write the number down and have it available whenever requesting technical assistance Troubleshooting The most recent revision of this manual and the service manual are available on the Internet at http www mallinckrodt com respiratory resp Serv_Supp ProductManuals html N 550 83 Blank Page Maintenance CAUTION Follow local governing ordinances and recycling instructions regarding the disposal or recycling of device components and accessories Returning the N 550 Service N 550 A Contact Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative for shipping instructions including a Returned Goods Authorization RGA number Unless otherwise instructed by Nellcor s Technical Services Department it is not nece
62. red SatSeconds setting Setting the Data Port Baud Rate Discussion The baud rate determines the speed at which the N 550 sends data to the attached equipment printer or portable computer The baud rate is determined by the capabilities of the attached equipment Procedure With the N 550 in the normal monitoring mode 1 Simultaneously press the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for 3 seconds Menu option 1 will be displayed N 550 37 Using the N 550 38 pa I g Lal i 4 w 590 2 Press the Adjust Up button until menu item option 4 is displayed r et e EID 5 3 Press the SatSeconds Alarm Limit button Current baud rate is displayed ntiuscon 2l mt t gt PTS t C2 Press the Adjust Up button or Adjust Down button to select the desired baud rate Possible settings are e 24 2 400 bps e 96 9 600 bps e 192 default 19 200 bps Using the N 550 Setting the Data Port Protocol With the N 550 in the normal monitoring mode 1 Simultaneously press the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for 3 seconds Menu option 1 will be displayed ra mt t E i ez e st990 3 Press the SatSeconds Alarm Limit button Current protocol is displayed N 550 39 Using the N 550 d
63. rm limit is 100 Pulse Rate alarm limits are 40 to 170 bpm SatSeconds alarm limit is set to off N 550 61 Printing N 550 Mode N 550 VERSION 1 00 00 CRC XXXX SpO2 Limit 85 100 PR Limit 40 1708PM ADULT 0 SAT S TIME SpO2 BPM PA Status The N 550 mode is ADULT Data Column Headings N 550 VERSION 1 00 00 CRC XXXX SpO2 Limit 85 100 PR Limit 40 170BPM ADULT 0 SAT S TIME 96SpO2 BPM PA Status Actual column headings are in the third row of the column heading line Patient data that is presented in the chart from left to right are the time that the patient data on the row was obtained the current SpO2 value being measured the current Pulse Rate in beats per minute bpm the current Pulse Amplitude PA and the operating status of the N 550 Time TIME 6SpO2 BPM PA Status 30 Sep 03 16 00 00 100 120 220 The Time column represents the N 550 real time clock Refer to the N 550 service manual to set the N 550 real time clock 62 Patient Data Operating Status N 550 Printing N 550 Version 1 00 00 CRC XXXX SpO2 Limit 85 100 PR Limit 40 170 bpm ADULT 0 SAT S TIME SpO2 BPM PA Status 30 Sep 03 16 00 00 100 190 220 PH Patient data is highlighted in the display above Parameter values are displayed directly beneath the heading for each parameter In this example the SpOz is 100 and the pulse rate is 190 beats per minute An asterisk indicates that the parameter is outside the set
64. ssary to return the sensor or other accessory items with the N 550 Pack the N 550 in its original shipping carton If the original carton is not available use a suitable carton with appropriate packing material to protect it during shipping Return the N 550 by any shipping method that provides proof of delivery WARNING The cover should be removed only by qualified service personnel There are no user serviceable parts inside The N 550 requires no routine service or calibration other than changing the battery at least every 24 months Refer to the N 550 service manual for the battery changing procedure If service is necessary contact qualified service personnel or your local Nellcor representative 85 Maintenance Periodic Safety Checks It is recommended that the following checks be performed every 24 months e Inspect the equipment for mechanical and functional damage e Inspect the safety relevant labels for legibility Cleaning CAUTION Do not spray pour or spill any liquid on the N 550 its accessories connectors switches or openings in the chassis For surface cleaning and disinfecting the N 550 follow your institution s procedures or e The N 550 may be surface cleaned by using a soft cloth dampened with either a commercial nonabrasive cleaner or a solution of 70 alcohol in water and lightly wiping the surfaces of the N 550 e The N 550 may be disinfected using a soft cloth saturated with a
65. st be turned off and back on again before a new trend printout can begin Column Headings N 550 VERSION 1 00 00 CRC XXXX SpO2 Limit 85 100 PR Limit 40 170BPM ADULT 0 SAT S TIME SpO2 BPM PA Status Column headings are displayed or printed after every 25 lines or if one of the values in the column heading changes 60 Printing Data Source N 550 VERSION 1 0 0 0 CRC XXXX SpO2 Limit 85 100 PR Limit 40 160BPM ADULT 0 SAT S TIME SpO2 BPM PA Status Data in the highlighted box above represents the model number of the N 550 in this case the N 550 Device Software Revision Level N 550 VERSION 1 00 00 CRC XXXX SpO2 Limit 85 100 PR Limit 40 170BPM ADULT 0 SAT S TIME SpO2 BPM PA Status The next data field tells the user the software level Version 1 00 00 and a software verification number CRC XXXX Neither of these numbers should change during normal operation The numbers may change if the N 550 is serviced and receives a software upgrade Alarm Limits N 550 VERSION 1 00 00 CRC XXXX SpO2 Limit 85 100 PR Limit 40 170BPM ADULT 0 SAT S TIME SpO2 BPM PA Status The last data field in the top line indicates the upper and lower alarm limits for SpO2 and for the pulse rate PR and the SatSeconds alarm setting OFF The SatSeconds setting may be OFF 10 25 50 or 100 depending on the SatSeconds alarm setting In the example above the low alarm limit for SpO2 is 85 and the upper ala
66. t gt gt PP WARNING Before use carefully read the sensor directions for use including all warnings cautions and instructions WARNING Do not use a damaged sensor or pulse oximetry cable Do not use a sensor with exposed optical components WARNING Use only Nellcor sensors and pulse oximetry cables with the N 550 Other sensors or pulse oximetry cables may cause improper N 550 performance WARNING Use only one pulse oximetry cable to increase the length of the sensor Use of more than one pulse oximetry cable may have an adverse effect on performance Do not attach any cable that is intended for computer use to the sensor port WARNING Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions WARNING Tissue damage can be caused by incorrect application or duration of use of an SpO sensor Inspect the sensor site as directed in the sensor directions for use 65 Sensors and Accessories 66 WARNING Do not immerse or wet the sensor When selecting a sensor consider the patient s weight and activity level the adequacy of perfusion and the available sensor sites the need for sterility and the anticipated duration of monitoring For more information refer to Table 2 or contact your local Nellcor representative For a complete and up to date listing of all sensors applicable to the N 550 refer to the Sensor A
67. ta Port Printout eeseeeeeeerenenenn 45 RDO Mr 45 el Mr 45 Using the Data POM 6 664 khao a OREOR CRM ROORODR RR CIO RR RC RR ORO 47 e p 47 Connecting to the Data Port sssssssssseeeees 47 Data Port Pino ts eese a eren 48 Contents Data Port Setup eicere nere ases Ub tis tuccerneussseecvsgcants 49 DISCUSSION darti Et eb E eH ILE UIS 49 irepeieW e REERETTUUM 50 Nurse Call Interface sssssssee 53 Setting Nurse Call RS 232 Polarity 54 Setting Nurse Call Relays Normally Open Closed 54 PIMOS Laxzdaus sqadCRAaAPAdERAAR RR RAE PARRRCSAR RARE ELC eee gd d Rd 57 Printing N 550 Real Time Data sssssss 57 Trend Data Printout eesseeeeesseeeennnrer 59 Column Headings d eeu E PE MERE be ER A aie 60 Data SOUIce enne epe o taies 61 Device Software Revision Level 61 Alarm DImlts sssoseibtt cin te Etat Iba tenta E este 61 N55 0 MOC MP 62 Data Column Headings seseseess 62 Bst e MU E 62 Patient Data cesarea sa inr re Ea ER eR 63 Operating STATUS i ttr e bei ae iin E 63 Sensors and Accessories 0000 eee e eee eee eee eee eee 65 Selecting a Sensor assaxitsiexantirisate o S tetra mp bc ERATES KE 65 Biocompatibility Testing d reci dated Gide 68 Optional
68. ted from the patient the N 550 remains in the Pulse Search Mode for awhile then the N 550 displays 3 dashes in the SpOz and pulse rate display One way to test the nurse call function is to create an alarm condition for example sensor disconnect and verify that your facility s nurse call system is activated WARNING The nurse call feature is not functional whenever the N 550 53 Using the Data Port The nurse call feature of the N 550 is operational when the N 550 is powered by AC power or battery power The nurse call feature of the N 550 works in conjunction with the nurse call system of your institution when the N 550 sounds an audible alarm The N 550 provides two different types of nurse call interfaces an RS 232 format and relay closure Both interfaces function when the N 550 is operating either on AC power or battery power The remote location is signaled anytime there is an audible alarm If the audible alarm has been turned off or silenced the nurse call function is also turned off Pin 11 on the data port is the RS 232 level nurse call signal and pin 5 or 10 is ground see Table 1 on page 48 When there is no alarm condition the voltage between pins 10 and 11 is 5 to 12 VDC Whenever the N 550 is in an alarm condition the output between pins 10 and 11 is 5 to 12 VDC This is the default condition normally low There is a service menu to change the default condition Refer to the N 550 service manua
69. th the N 550 and the instrument connected to it must be connected to a grounded outlet Accessory equipment connected to the N 550 s data interface must be certified according to IEC Standard 60950 for data processing equipment or IEC Standard 60601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 60601 1 1 systems requirements Anyone who connects additional equipment to the signal input port or signal output port N 550 data port connector configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC Standard 60601 1 1 and the electromagnetic compatibility system standard IEC Standard 60601 1 2 The N 550 accuracy may degrade if it is connected to secondary I O devices when the instrument is not connected to earth reference CAUTION Do not lift the N 550 by the sensor cable or power cord because the cable or cord could disconnect from the N 550 causing damage to the N 550 or injuring the patient CAUTION Federal law U S A restricts this device to sale by or on the order of a physician Safety Information Notes Notes are identified by the Note symbol shown above Notes provide additional useful information N 550 3 Blank Page Introduction A WARNING The N 550 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms
70. ting Note When an alarm limit is changed from power on default the LA N 550 displays a decimal point after the changed parameter 34 Using the N 550 pa mi t Seo Ri 3 Press the SpO2 Alarm Limit button twice to view the current C N 550 SpO2 lower alarm limit pa d 5 gt 4 Press the Adjust Up button or Adjust Down button to increase or decrease the alarm limit setting 5 Press the Pulse Rate Alarm Limit button to view the current upper alarm limit for Pulse Rate pa d sts00 6 Press the Adjust Up button or Adjust Down button to increase or decrease the alarm limit setting 35 Using the N 550 7 Press the Pulse Rate Alarm Limit button twice to view the current C lower alarm limit for Pulse Rate D g 9 BA if stSn C 8 Press Adjust Up button or Adjust Down button to increase or C2 decrease the alarm limit setting Setting SatSeconds Duration Discussion Refer to Describing SatSeconds on page 90 for a description of the SatSeconds function Procedure With the N 550 in the normal monitoring mode 1 Press the SatSeconds Alarm Limit button The current SatSeconds setting is displayed 36 Using the N 550 on v 9 Lg gt y A Note The possible settings for SatSeconds are Off 10 25 50 and LA 100 seconds 2 Press the Adjust Up button or Adjust Down button to select the C2 desi
71. tton to save the desired baud 6 Simultaneously press and hold the SpO Alarm Limit button and Pulse Rate Alarm Limit button for at least 3 seconds Option 1 will be displayed N 550 51 Using the Data Port E e g 2 44z600 2l d Es II Anesa selected protocol will be displayed TR 8 Press the SatSeconds Alarm Limit Button to select Option 5 The 52 ra e ES I 44208 H Note The available selections are e Real time ASCII e 2 External equipment communications Refer to the external equipment manuals for the interfacing instructions Using the Data Port 9 Press the Adjust Up button or the Adjust Down button to display G2 the desired protocol 10 Press the SatSeconds Alarm Limit button to save the desired protocol Nurse Call Interface WARNING The nurse call feature should not be used as the primary source of alarm notification The audible and visual alarms of the pulse oximeter used in conjunction with clinical signs and symptoms are the primary sources for notifying medical personnel that an alarm condition exists pulse oximeter alarms are silenced Caution The nurse call function needs to be tested after it has been set up in your facility The nurse call feature should be tested whenever setting up the N 550 pulse oximeter in a location that uses nurse call If an attached OxiMax sensor is disconnec
72. ubject the N 550 to extreme moisture such as direct exposure to rain Such exposure may cause inaccurate performance or device failure 15 Setting up the N 550 gt gt PP WARNING Do not use an N 550 sensor cables or connectors that appear to be damaged WARNING The N 550 is not defibrillator proof However it may remain attached to the patient during defibrillation or while an electrosurgical unit is in use but the readings may be inaccurate during use and shortly thereafter WARNING In the USA do not connect the N 550 to an electrical outlet controlled by a wall switch because the N 550 may be accidentally turned off WARNING Use only the DOC 10 pulse oximetry cable with the N 550 Use of another sensor cable will have an adverse effect on performance Do not attach any cable that is intended for computer use to the sensor port Do not connect any device other than a Nellcor approved sensor to the sensor connector List of Components 1 N 550 Pulse Oximeter 1 Nellcor Sensor or Assortment Pack 1 DOC 10 Pulse Oximeter Cable 1 N 550 Operator s Manual 1 Hospital Grade Power Cord or power cord appropriate for country of sale 1 Sensor Accuracy Grid 1 Quick Guide Setting up the N 550 Connecting the N 550 to AC Power 1 Power Connector 1 Plug the female connector of the power cord into the N 550 AC power connector 1 2 Plug the male connector of the power cor
73. utton one time to decrease the display by one digit Holding the Adjust Down button down for more than one second cause the display digits to scroll The SpO2 Alarm Limit button is used to view the SpO2 alarm limit When the SpO Alarm Limit button is pressed at the same time as the Pulse Rate Alarm Limit button for approximately three seconds the menu options are enabled The Pulse Rate Alarm Limit button is used to view the pulse rate alarm limit When the Pulse Rate Alarm Limit button is pressed at the same time as the SpO2 Alarm Limit button for approximately three seconds the menu options are enabled The SatSeconds Alarm Limit button is used to view the SatSeconds alarm limit When pressed the menu options are enabled The Adjust Up and Adjust Down buttons are used to change the SatSeconds limit settings Description of Controls Indicators and Symbols Description of Displays and Indicators N 550 M SpO2 O min ecc Sec R I E IE I The Pulse Amplitude Indicator blip bar A 10 segment LED that indicates pulse beat and shows the relative pulse amplitude As the detected pulse becomes stronger more bars light with each pulse The SpO2 Display Shows the saturation level of oxygenated hemoglobin The display value flashes zero during loss of pulse alarms and flashes the SpO2 value when the SpOz is outside the alarm limits During pulse search the N 550 continues to update t
74. vascular line Reposition the sensor as necessary e Excessive environmental motion or electromagnetic interference may be preventing the N 550 from tracking the Troubleshooting pulse Remove the source of interference or try to stabilize the environment or do both 6 The letters EEE followed by a number appear on the display e This is an error code To confirm press the Power On Off button to turn the N 550 off then press the button again to turn it back on If the display shows the error code once again record the number and provide that information to qualified service personnel or your local Nellcor representative e Error Code EEE 513 is displayed when the battery is discharged to a critically low level Turn the N 550 off and let it charge for about 10 minutes and then turn the N 550 back on If the error code is still present turn the N 550 off and let it continue to charge If the N 550 has been charged for 30 minutes and the error code is still present notify service personnel Refer to the N 550 service manual for a complete listing of error codes EMI Electro magnetic Interference N 550 e CAUTION This device has been tested and found to comply with the limits for medical devices to the IEC 60601 1 2 EN60601 1 2 and the Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful interference in a typical medical installation However bec
75. very 3 minutes when alarms are silenced with the alarm silence duration set to OFF Pulse Beep A single beep sounds for each detected pulse The pitch changes as monitored SpO2 values increase or decrease Volume Setting Tone A continuous tone that is used to adjust the alarm volume Confirmation Tone Three beeps sound to indicate that default settings have been saved or reset to factory defaults or trend data has been deleted 14 Setting up the N 550 N 550 P PPP PP WARNING Explosion hazard Do not use the N 550 pulse oximeter in the presence of flammable anesthetics or gases WARNING Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions See the appropriate sections of the manual for specific safety information WARNING To ensure patient safety do not place the N 550 in any position that might cause it to fall on the patient WARNING As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation WARNING Disconnect the N 550 and Nellcor sensor from the patient during magnetic resonance imaging MRD scanning Induced current could potentially cause burns The N 550 may affect the MRI image the MRI unit may affect the accuracy of oximeter measurements WARNING To ensure accurate performance and prevent device failure do not s

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