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OPERATOR`S MANUAL

1. Alarm Summary 42 L AUDIBLE ALARM OFF button has not been pressed after alarm occurs e Alarm condition present Audible alarm Flashing display e Alarm condition ceases to exist non latching option Audible alarm stops Display stops flashing e Alarm condition ceases to exist latching option Audible alarm and Flashing display continues until AUDIBLE ALARM OFF button is pressed Start Up and Use 2 AUDIBLE ALARM OFF button has been pressed after alarm occurs e Alarm condition still present Ee Noaudible alarm for silence duration AUDIBLE ALARM OFF indicator lights Flashing display continues e Alarm condition ceases to exist Noaudible alarm Noflashing display NoAUDIBLE ALARM OFF indicator 3 Audible alarm silence duration set to OFF e Noalarm condition is present No audible alarm Audible alarm off reminder at 3 minute intervals AUDIBLE ALARM OFF indicator flashes e Alarm condition occurs Noaudible alarm Audible alarm off reminder at 3 minute intervals AUDIBLE ALARM OFF indicator flashes Display flashes continuously for out of limit parameter ADJUSTING ALARM LIMITS Overview When the N 3000 is first turned on alarm limits will be set to their power on default values Power on default alarm limits can be changed by qualified personnel with the N 3000 in the configuration mode described in the N 3000 service manual You can change alarm limits from de
2. e Accuracy can be affected by incorrect sensor application and use significant levels of dysfunctional hemoglobins intradermal or intravenous dyes bright light excessive patient movement venous pulsations electrosurgical interference placement of a sensor on an extremity that has a blood pressure cuff arterial catheter or intravascular line e Observe all instructions warnings and cautions in this manual and in the sensor directions for use EMI INTERFERENCE The N 3000 has been tested and found to comply with the limits for medical devices to the EN60601 1 2 1993 EN60601 1 2 1994 Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful electromagnetic interference EMI in a typical medical installation In addition the device contains alarms which notify the user when EMI is detected although detection cannot be assured in all cases 57 Troubleshooting and Maintenance 58 Because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in the health care environment for example cellular phones mobile two way radios electrical appliances it is possible that high levels of EMI interference due to close proximity or strength of a source may result in disruption of performance of the N 3000 The N 3000 generates uses and can radiate radio frequency energy and if not installed and used in accordance
3. Start Up and Use To adjust neonatal alarm limits switch to neonatal mode then follow the procedures in the Adjusting Alarm Limits paragraph ysi 6uR PATIENT TREND DATA N 3000 patient trend data is available to be displayed as waveforms or in a tabular format on a stacked and active N 3200 Refer to the N 3200 operator s manual to display and print N 3000 trend data Additionally the data is available for viewing on a PC attached to the N 3000 serial port Contact Nellcor Puritan Bennett s Technical Services Department or your local Nellcor Puritan Bennett representative for serial port protocol information Data stored includes SpO2 percent pulse rate pulse amplitude and alarm status The N 3000 uses one of three selectable formats to record samples of parameters of patient data Format 1 is the default format The configuration mode as detailed in the N 3000 service manual can be used by qualified service personnel to change the default format setting Format 1 Patient data is sampled for 10 seconds and the average of the measurements during that period is recorded Trend data is available for the last 24 hours of actual monitoring during the previous 5 days If an alarm occurs anytime during that period it is recorded Format 2 Patient data is sampled for 20 seconds and the maximum and minimum values during that period are recorded Trend data is available for the last 32 hours of actual monitoring during
4. 3000 If a failure occurs the N 3000 will display an error code as indicated in the Troubleshooting and Maintenance section N 3000 Turn On Procedure 32 The safe and proper working condition of the N 3000 can be verified through the completion of the power on self test in the following procedure 1 Ensurethat the SpO2 cable with sensor is connected to the N 3000 Press the ON STANDBY button You will hear three consecutively higher pitched beeps and the POWER ON indicator will light 2 All indicators light for a few seconds Caution If any indicator or display element does not light do not use the monitor Instead contact qualified service personnel your local Nellcor Puritan Bennett representative or the Nellcor Puritan Bennett s Technical Services Department If segments of the digital displays or other indicators do not light notify service personnel and do not use the N 3000 3 Digital displays individually light in a scanning test pattern Following a successful self test you will hear a 1 second tone and all indicators will light while the tone sounds If a self test fails you will hear an alarm and you may see an error code in the digital display If this occurs press the ON STANDBY button to turn the unit off Attempt to restart If the unit again fails the self test refer to the Troubleshooting and Maintenance section Start Up and Use Note The bottom segment of the pulse amplitude indicator
5. Biocompatibility testing has been conducted on NPB s sensors in compliance with ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing which suggests cytotoxicity sensitization and irritation or intracutaneous reactivity testing be performed on devices falling into this category The sensors have passed the recommended biocompatibility testing and are therefore in compliance with ISO 10993 1 ELECTRICAL CLASSIFICATION IEC 601 1 Protection Class Class per I E 601 1 clause 2 2 4 Degree of Protection Type CF per I E 601 1 clause 2 2 26 Enclosure Degree of Protection Ordinary IP X0 63 Specifications Mode of Operation Continuous Emissions Compliance EN55011 E missions Classification CISPR II Group Class B Battery Type Rechargeable sealed lead acid internal battery Operating Time 4 hours minimum from a new fully charged battery in stand alone configuration age and usage affect battery performance Recharge Period 14 hours for full charge 6 hours for 1 hour operating time Expected Battery Life Age and usage patterns will affect the capacity of the N 3000 battery If the monitor is operated primarily from auxiliary power supplies its battery will maintain nominal capacity for at least two years In situations of intensive battery use where the monitor is operated frequently in portable applications for example battery life can be as short as six months
6. Factory Alarm Default Settings cesceeseeeee cee 65 Factory General Default Settings cccseeeeeeee 66 Hertormance cececeaaeeeeeeeeseeanaeeeeeeeeeqenaees 66 Measurement Range c ceeeeeeeeeeeeeeeee caeeeeenaeeeeeenas 66 Pulse Rate Display Update Frequency sssessseneen 66 Alarm Limit Range Adult Pediatric and Neonate 66 Alarm Characteristics c cccccceccecesseeese eener eerren 67 AEEHISEN EPEE EEEE EER TEE T 67 Environmental Conditions c cceeceeeeeeeeeee ceeeeeeeeeeeeeees 68 Transport and Storage in shipping container 68 Transport and Storage not in shipping container 68 OPOAUON RE 68 Appendix Principles of Oximetry ccccccccce cette A 1 Pulse Oximetry Overview ceeeeeeeeeteeeeees A 1 Automatic Calibration s es ceeeeseteeesaeeseeeeees A 2 Functional Versus Fractional Saturation 0 ceeeee A 2 Measured Versus Calculated Saturation 0 ceeeeeee A 3 vii Ee Contents FIGURES 1 N 3000 Front Panel North American AA 7 2 N 3000 Front Panel International 0 cesses eee 8 3 N 3000 Rear Panel 8 4 N 3000 Right Side Panel North American 9 5 N 3000 Right Side Panel International ccceeee 9 6 N 3000 Top Panel oecniinnisuniues niini A NA 10 7 N 3000 Left Side Panel 10 8 Connecting to the SPS External Power Supply 19 9 Connecting Power Con 19 10 Connecting to the
7. In these applications it is recommended that the battery operating time be tested every six months and the battery replaced if the capacity is less than two hours of operating time Avoiding deep discharge and operating from auxiliary power supplies where possible will prolong battery life and preserve capacity N 3000 Input Voltage 15V DC Specifications External Power Supplies Input Voltage Current Model SPS N or N1 100 120 VAC 500 mA max 50 60 Hz Model SPS I or 11 100 240 VAC 1 3 amps 50 60 Hz Model PSS lor 1I 100 240 VAC 1 3 amps 50 60 Hz Ee Output Voltage 15V DC PHYSICAL CHARACTERISTICS Dimensions Height when used standalone 6 8 cm 2 68 in Height excluding docking pedestal 5 4 cm 2 13 in Width 23 9 cm 9 41 in Depth 14 7 cm 5 79 in Weight 1 8 kg 4 0 Ib FACTORY SETTINGS Factory Alarm Default Settings Adult Pediatric Neonate SpO2 Upper Alarm Limit 100 95 SpO2 Lower Alarm Limit 85 80 Pulse Rate Upper Alarm Limit 170 bpm 190 bpm Pulse Rate Lower Alarm Limit 40 bpm 90 bpm 65 Specifications Factory General Default Settings Operating M ode Pulse Beep Volume Audible Alarm Volume Audible Alarm Silence Duration Alarm Silence Reminder Latching Alarms Serial Port Baud Rate Trend Format PERFORMANCE Measurement Range SpO2 0 100 Pulse Rate 20 250 bpm Pulse Rate Display Update Frequency Adult Pediatric 57 5 dB A at 1 meter
8. measured by an SpO2 sensor The monitor is intended for use on adult pediatric and neonatal patients in all hospital areas hospital type facilities and home environments It may be used during intra hospital transport when powered by its internal battery The N 3000 can operate as a standalone monitor or it can be connected to stacked with other Nellcor Symphony instruments such as the N 3100 blood pressure monitor and N 3200 display printer When used with the N 3200 display printer the instruments can display and print out plethysmographic waveforms and SpO2 and pulse rate tabular data WARNING The N 3000 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms ABOUT THIS MANUAL This manual explains how to set up and use the N 3000 pulse oximeter Important safety information relating to general use of the N 3000 appears before this introduction Other important safety information is located throughout the text where appropriate Read the entire Safety Information section before you operate the monitor In addition to the safety section this manual includes the following sections e Controls Indicators and Symbols shows the monitor locates all controls indicators and symbols and explains their functionality Ee Introduction Setup explains how to set up the monitor and connect it to other Ndlcor Symphony instruments and accessories Sen
9. 0cc an 53 TFroubleShooting sarts renet eas ee d ses Reer EEE RRE 58 Error COGS EH 58 EEN 54 EEE DEE ee a a ee 54 EEE OB Piiale aaraa aeaaea aana eataa a iara enkaa 54 Error Condgons c cccccccccccecsseceeees ceeeeeeseeeeessaeeeeeeaaes 54 EMI Interferences EN 57 Compliance with Test Limits for a Class B Digital Device 59 Periodic Safety Checks cccccceeeeeeeneeee ceeeeeaeeeeeeeeeeees 59 ele 60 Gleanings EEN 60 Battery Maintenance AAA 60 Obtaining Technical Assistance 0 cccceeeeceeseeee eee 61 Returning System Components sssesseesseeseeesieesrree nrsrrnees 61 SPOCCiTICALIONS EE 63 General asea EEA AEAN 63 SONSOMS o reee ee e eetas ER EEEE EE EERS 63 vi Contents Electrical Classification cc cccccecseeeeesee ceeeeeeeeeeeeeeeeseees 63 Protection Class cccccceesceceeeeeseeeee caeeeeeeeeseaeeesaeeeenees 63 Degree Of Protection ledene i a ea 63 Enclosure Degree of Protection seceeeeeeeeee eee 63 Mode of Operation 2 cccccceccceeceeeteee ceseeeeeeeeseeeeenaees 64 Emissions Compliance ccscceeeceeeeeeee ceeeeeneeeeees 64 attente EES E 64 N 3000 Input Voltage isseire ienen 64 External Power Supplies cccecccseeeseeeeseeeeneeeeees 65 Physical Characteristics c cccccecessceeeeeeeeceeeesseeeeneeeeees 65 DIMENSION sek cecil ve Mar ath A tate has estate cele ba 65 NN EE ee ttn nie et sa one ei ete nts 65 Factory e E 65
10. Indicators and Symbols Control knob Audible Alarm Off button Figure 6 N 3000 Top Panel Speakers Handle Figure 7 N 3000 Left Side Panel N 3000 SYMBOLS Rear Panel EK New Patient Neonatal Button Data Interface Attention Refer to Manual 10 Right Side Panel SpO2 w Controls Indicators and Symbols SpO2 Cable Input Ee Type CF Equipment SPS EXTERNAL POWER SUPPLY SYMBOLS gt Input Voltage Output Voltage Equipotential Ground Terminal Caution Shock Hazard Power Available Indicator DESCRIPTION OF CONTROLS PRINT Pi Hai The ON STANDBY button is used to turn the N 3000 on or off Three consecutively higher pitched beeps sound when turning the N 3000 on and three consecutively lower pitched beeps sound when turning the N 3000 off The NEW PATIENT NEONATAL button on the rear panel is used to clear stored patient data or to switch between adult pediatric and neonatal modes The AUDIBLE ALARM OFF button is used to silence current audible alarms for the selected alarm silence duration period The PRINT button is used when the N 3000 and the N 3200 display printer are stacked to cause the N 3200 to begin printing current N 3000 data The UPPER ALARM LIMIT button is used to view and set upper alarm limits 11 Controls Indicators and Symbols G N The LOWER ALARM LIMIT button is used to view and set lower a
11. PSS External Power Supply 0 20 11 Removing the N 3100 Top Cover 22 12 Connecting oeh 2100 22 13 Removing the N 3000 From the N 3100 0 eeeeeeeee 23 14 Serial Port Interface 0 ec eceeceeeeeeeeeee ceeeeeeeeeeeeseeeeeseeeeeas 24 15 Connecting SpO2 Sensor to SCP 10 Cable 0008 29 16 Monitoring Conditions and Alarm Responses 00s100 37 17 Selecting Smart Pulse Rate Alarm Lime 46 18 Setting Audible Alarm Silence Duration to On 48 A 1 Oxyhemoglobin Dissociation Curve cceesseseseeeeeee ees A 3 TABLES 1 Compatible Nellcor Puritan Bennett Sensors eeeeeeeae 28 Audible Alarm Off Duration 40 viii SAFETY INFORMATION General Safety Information ysi 6uR GENERAL SAFETY INFORMATION This section contains important safety information related to the general use of the Nelicor Symphony N 3000 Pulse Oximeter Other important safety information appears throughout in sections that relate specifically to the precautionary information Read all text surrounding all precautionary information Important Before use carefully read this manual accessory directions for use all precautionary information in boldface type and specifications WARNING Explosion hazard Do not use the N 3000 pulse oximeter in the presence of flammable anesthetics WARNING The N 3000 is to be operated by qualified personnel only Before use carefully read this manual accessory dire
12. at the end of the alarm silence duration To deactivate the feature before the alarm silence duration has expired press the AUDIBLE ALARM OFF button twice within 2 seconds Again three beeps indicate that this feature has been deactivated The AUDIBLE ALARM OFF indicator is extinguished While in the all alarm silence mode no alarms will sound during the alarm silence duration including those of a higher priority The appropriate parameter displays or indicators however will flash Similarly if any alarm condition is corrected and then recurs during the alarm silence duration no alarms will sound but the appropriate parameter displays or indicators will flash 41 Start Up and Use Latching Alarm Option Qualified service personnel can configure your system to have latching alarms The factory default is non latching alarms Latching alarms The parameter display flashes and an audible alarm sounds even after the alarm condition no longer exists until you press the AUDIBLE ALARM OFF button Note If the N 3000 is configured for latching alarms and the AUDIBLE ALARM OFF button is pressed during a high or medium priority alarm the parameter display will stop flashing when the alarm condition is no longer present Non latching alarms The parameter display flashes only until the alarm condition no longer exists The audible alarm sounds until the condition no longer exists or until you press the AUDIBLE ALARM OFF button
13. changed by qualified service personnel using the configuration mode described in the service manual for the instrument needing to be changed 51 Start Up and Use BATTERY OPERATION 52 In case of loss of external power the N 3000 operates on its internal battery that provides at least 4 hours of operation from a new fully charged battery when operating independently of the N 3100 and N 3200 When operating in the stacked configuration with the N 3200 either the N 3000 battery or N 3200 battery provides power to the stack depending on which battery has the higher charge voltage When stacked with the N 3100 battery life varies depending primarily on the frequency of N 3100 blood pressure measurements Recharge the N 3000 after extensive battery use or after the BATTERY IN USE BATTERY LOW indicator has been flashing If the monitor is not recharged the monitor may fail to operate or stop operating suddenly When the N 3000 is connected to an external power supply or is stacked with an N 3200 connected to AC power or stacked with an N 3100 connected to an active SPS or PSS external power supply the self contained battery automatically recharges whether the N 3000 is on or off A complete recharge of a fully drained battery requires 14 hours Caution If the N 3000 is to be stored for a period of 24 months or longer notify service personnel to remove the battery from the monitor prior to storage Recharge the batter
14. detected and the data display is routinely updated ysi 6uR Pulse search mode during which the PULSE SEARCH indicator lights the data display alternates between data and dashes and the data evaluation period is ongoing The data display is updated when a qualified pulse is detected Loss of pulse mode during which an alarm sounds the PULSE SEARCH indicator flashes and the data displays flash zeroes Alarm Descriptions The N 3000 has five levels of audible alarms 1 High priority alarm Indicated by a high rate high pitched pulsing tone A high priority alarm sounds after loss of pulse is detected refer to the Management of the Loss of Pulse Alarm paragraph in this section Medium priority alarm Indicated by a medium rate medium pitched pulsing tone A medium priority alarm sounds and the corresponding parameter display flashes when any measured patient parameter moves outside the set alarm limits A medium priority alarm also sounds during battery operation when 15 minutes or less battery capacity remains Low priority alarm Indicated by a low rate low pitched pulsing tone A low priority alarm sounds during the following conditions e When an SpO 2 cable has disconnected this alarm function is inactive from the time the N 3000 is turned on until the cable is connected e 50 seconds after loss of pulse is detected in the presence of continuous motion Microprocessor failure alarm Indicated by
15. in the N 3000 service manual The setting OFF can not be selected as a power on default setting To view the current audible alarm silence duration press and hold the AUDIBLE ALARM OFF button for less than 3 seconds The setting is displayed similarly to that shown below Sp02 PULSE RATE min L6e sec WARNING If an alarm condition except those for low battery power failure and microprocessor failure occurs while the audible alarm silence period is set to OFF the only alarm indication will be visual displays related to the alarm condition You can set the audible alarm silence period to 30 60 90 or 120 seconds or to OFF To adjust the audible alarm silence period press and hold the AUDIBLE ALARM OFF button Within 3 seconds after pressing the AUDIBLE ALARM OFF button turn the control knob until you see the desired alarm silence duration in the PULSE RATE display The displayed setting takes effect when you release the AUDIBLE ALARM OFF button When operating in the stacked configuration setting the audible alarm silence period for one instrument causes any other active instrument in the stack to be set to the same period 47 Start Up and Use Shortcut to Select OFF for Audible Alarm Silence Duration To quickly select OFF for the N 3000 audible alarm silence period simultaneously press the AUDIBLE ALARM OFF button and the UPPER ALARM LIMIT button as shown in Figure 16 Figure 18 Setting Audible A
16. mounting adapter such as the Ndlcor Symphony DB 1 mounting kit the N 3000 may be attached to an IV pole bed rail wall mount or headboard 2 Placethe SPS power supply on a flat surface near the N 3000 so the power supply cable will reach the N 3000 Caution For AC operation use only the Nedlicor Symphony SPS N1 North America SPS I1 international PSS 1 North America or PSS 1I international external power supplies Use of other power supplies may result in damage to or improper operation of the N 3000 3 Plug the SPS power supply cable into the socket on the right side of the N 3000 The connector will engage only one way with the cable toward the rear of the monitor as illustrated in Figure 8 18 Setup SpO2 connector N 3000 right side External power supply Equipotential terminal Ee External power supply cable Figure 8 Connecting to the SPS External Power Supply 4 Connect the Nellcor Puritan Bennett power cord to the external power supply as shown in Figure 9 Power available indicator Nellcor Puritan Bennett hospital grade power cord External power supply Figure 9 Connecting Power Cord WARNING In the USA do not connect to an electrical outlet controlled by a wall switch because the device may be accidentally turned off 5 Plug the power cord into a properly grounded AC outlet 6 Useonly the original hospital grade AC power cord provi
17. oxygen transducer OXI A N lt 3 or gt 40 kg reusable with disposable non OXI P I 3 40 kg sterile shee Durasensor oxygen transducer Kg 100A ee reusable non sterile Nellcor Puritan Bennett Bae 10 a g reflectance oxygen transducer Taaa oa sterile Dura Y multisite oxygen transducer non sterile reusable For use with Dura Y sensors Ear clip reusable non sterile Pedi Check pediatric spot check clip reusable non sterile oxygen transducers sterile single use only lt 3 or gt 20 kg 3 to 40 kg gt 30 kg BIOCOMPATIBILITY TESTING 28 Biocompatibility testing has been conducted on Nellcor Puritan Bennett sensors in compliance with ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing The sensors have passed the recommended biocompatibility testing and are therefore in compliance with SO 10993 1 Sensors and Accessories CONNECTING SPO2 SENSORS Use only notched Nellcor Puritan Bennett sensors such as those indicated in Table 1 which are compatible with the SCP 10 cable Connect the sensor to the SCP 10 cable locking it into place as illustrated in Figure 15 Notice that the sensor connector and SCP 10 connector are shaped to fit together only one way with the NELLCOR name on the upper side of the connector OXISENSOR II SCP 10 connector Figure 15 Connecting SpO2 Sensor to SCP 10 Cable 29 Ee Sensors and Accessories PERFORMANCE CONSIDERATIO
18. stack press the docking release button on the rear pane of the bottom instrument and slide the top instrument off the bottom instrument Figure 13 Removing the N 3000 From the N 3100 23 Setup SERIAL INTERFACE 24 WARNING To ensure patient electrical isolation connect only to other equipment with electrically isolated circuits The N 3000 serial interface provides patient data output using EIA 232 or RS 422 signal levels and is located on the rear panel When data is requested by a computer connected to the serial interface port requested data is checked to ensure integrity and then sent out through the port in a proprietary format The serial port is functional only when the N 3000 is operating on AC power Use of the port by a qualified programmer requires an ElA 232 Nellcor Puritan Bennett cable purchased separately to connect the N 3000 with the computer as illustrated in Figure 14 The cable and directions for use are available by contacting Nellcor Puritan Bennett Technical Services or your local Nellcor Puritan Bennett representative Figure 14 Serial Port Interface This output port can also be configured to provide an alarm active function instead of serial data Noe When the N 3000 is configured for the alarm active function the serial data interface connector is ded
19. the rear pane of the N 3200 21 Setup 2 Press the docking release button on the rear of the N 3100 or N 3200 to remove the top cover and expose the docking connector N 3100 illustrated in Figure 11 Docking release button on rear panel NELLCOR Symphony N 3100 Figure 11 Removing the N 3100 Top Cover 3 Slide the N 3000 onto the N 3100 or N 3200 until the docking connectors firmly engage and you hear a click See Figure 12 SYSTOLIC DIASTOLIC mmHg mmHg Figure 12 Connecting to the N 3100 4 Operate the N 3000 as indicated in the Start up and Use section of this manual 22 Setup Note TheSTACKED indicators on the N 3000 the N 3100 and N 3200 in a stack will light while the instruments are stacked communicating and power is turned on If the STACKED indicator does not light refer to the Troubleshooting and Maintenance section Ee Read the N 3100 or N 3200 operator s manual before using the stacked configuration REMOVING THE N 3000 FROM THE N 3100 OR N 3200 Note When operating on battery power you may remove the N 3000 from the N 3100 while the N 3000 is ON However the N 3100 must be off prior to removal from the stack in order to avoid a power failure alarm If a power failure alarm occurs press the N 3100 AUDIBLE ALARM OFF button to silence the alarm To remove a Ndlcor Symphony instrument from the
20. with these instructions may cause harmful interference with other devices in the vicinity Disruption may be evidenced by erratic readings cessation of operation or incorrect functioning of other devices If this occurs the site of use should be surveyed to determine the source of this disruption The following actions may be taken to eliminate the source e Turn equipment in the vicinity off and on to isolate the source of interference e Reorient or relocate the N 3000 or the receiving device e Increase the distance between the N 3000 and the other equipment e Select alternative power receptacle A C power outlet If assistance is required contact Nellcor Puritan Bennett s Technical Services Department or your local Nellcor Puritan Bennett representative Troubleshooting and Maintenance COMPLIANCE WITH TEST LIMITS FOR A CLASS B DIGITAL DEVICE This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 103 of the FCC Rules and CISPR II Class B These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur ina particular installation If this equi
21. ANCE For technical information and assistance or to order a service manual contact Nellcor Puritan Bennett s Technical Services Department or your local Nellcor Puritan Bennett representative The service manual includes information required by qualified service personnel when servicing the N 3000 RETURNING SYSTEM COMPONENTS If it is necessary to return the N 3000 or the external power supply for service call Nellcor Puritan Bennett s Technical Services Department or your local representative for shipping instructions Have all equipment serial numbers available when calling To pack the N 3000 for return disconnect the sensor sensor cable and external power supply It is not necessary to return the sensor To pack the SPS power supply disconnect the power cord Pack items to be returned in their original shipping carton if available If not use a suitable carton with appropriate packing material to protect the item or items during shipping 61 SPECIFICATIONS General m Electrical Classification a Physical Characteristics e Factory Settings Performance Environmental Conditions Environmental Protection GENERAL Designed to meet safety requirements of UL 2601 1 CSA C22 2 No 601 1 M 90 EN60601 1 1995 ISO 9919 EMC per EN60601 1 2 1993 ISO 10993 1 Sensors Sensors Nellcor Puritan Bennett s oxygen transducers sensors can be categorized as surface devices contacting skin for a limited duration of time
22. MOTION indicator lights when patient motion is detected by the N 3000 NEONATAL or NEO LINKED zO amp Controls Indicators and Symbols The NEONATAL indicator lights when the N 3000 is in neonatal mode Ee The LINKED indicator lights when data is being transmitted from the N 3000 to a remote monitoring station The POWER ON indicator to the right of the ON STANDBY button lights continuously while the N 3000 is on The AUDIBLE ALARM OFF indicator lights steadily to signify that the current audible alarm has been temporarily silenced If the alarm condition ceases prior to the end of the alarm silence duration the light goes out While the condition exists the indicator remains lit for the selected duration or until a higher priority alarm condition arises in which case the AUDIBLE ALARM OFF indicator is no longer illuminated and an alarm sounds The indicator flashes when the audible alarm silence duration is set to OFF When the N 3000 or an attached N 3100 has the audible alarm silence duration set to OF F during an alarm condition the AUDIBLE ALARM OFF indicator flashes and the audible alarm off reminder will sound at 3 minute intervals The latter occurs only if the N 3000 or any attached N 3100 has had the audible alarm off reminder enabled using the service mode as described in the N 3000 service manual The BATTERY IN USE BATTERY LOW indicator lights continuously when the bat
23. NS WARNING Pulse oximetry readings and pulse rate signals can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions Use only Nellcor Puritan Bennett sensors and sensor cables Select an appropriate sensor apply sensor as directed and observe all warnings and cautions presented in the directions for use accompanying the sensor 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 cover the sensor site with opaque material Failure to take this action 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 Movethe sensor toa less active site e Usean adhesive sensor that tolerates some patient motion e Usea new sensor with fresh adhesive backing 30 START UP AND USE Power on and Self Test Clearing Data Neonatal Mode Patient Trend Data Description of Alarms Adjusting Alarm Limits Selecting Smart Pulse Rate Alarm Limits Adjusting Audible Alarm Silence Duration Adjusting Audible Alarm Volume Adjusting Pulse Beep Volume Technical Staff Adjustable Fe
24. Troubleshooting and Maintenance BATTERY IN USE indicator lights steadily while the N 3000 is connected to its external power supply and AC outlet e Make sure that the external power supply is properly connected to the N 3000 and to the hospital grade power cord e Confirm that the Power Available indicator on the external power supply is on If it is not and connections are good the external power supply may be defective Notify your service personnel e Check to see if power is available to other equipment on the same AC circuit The PULSE AMPLITUDE indicator seems to indicate a pulse but the digital displays show zeroes e Check the patient e Excessive patient motion may be making it impossible for the N 3000 to acquire a good pulse signal If possible keep the patient still Check whether the sensor is applied securely and properly and replace if necessary or move the sensor to a new site e Thesensor or cable may be damaged replace it e Thesignal may be too low to allow the N 3000 to measure oxygen saturation and pulse rate 55 Ee Troubleshooting and Maintenance 56 4 SpO2or pulse rate values change rapidly pulse amplitude indicator is erratic Check the patient Excessive patient motion may be making it impossible for the N 3000 to acquire a good pulse signal If possible keep the patient still Check whether the sensor is applied securely and properly and replace if necessary or move the sens
25. You turn the instrument off and then back on where limits revert to power on defaults e You use standard alarm setting procedures to select new pulse rate alarm limits e You reactivate the Smart pulse rate alarm limits setting as described above e You see an error code displayed indicating current limits have been lost ADJUSTING AUDIBLE ALARM SILENCE DURATION 46 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 the audible alarm silence duration The audible alarm silence duration starts when you press the AUDIBLE ALARM OFF button Start Up and Use If an alarm of the same or lower priority occurs during the audible alarm silence duration it will not be heard until the end of the duration If the alarm condition is still present or a new alarm occurs after the audible alarm silence duration has elapsed an audible alarm will sound Ee An alarm with a higher priority will sound regardless of whether the duration has ended Also if alarm condition ceases to exist before the audible alarm silence duration has ended any alarm condition will cause an alarm to sound The power on default audible alarm silence duration setting is in effect unless it is changed The power on default set at the factory is 60 seconds The power on default setting can be adjusted by service personnel using the configuration mode as indicated
26. a shrill continuous tone A microprocessor alarm sounds when the microprocessor has failed 39 Start Up and Use 40 5 Powe failurealarm Indicated by a shrill pulsing tone A power failure alarm sounds when the N 3000 loses power for any reason other than when the ON STANDBY button is pressed As shown in the Alarm Summary paragraph later in this section alarm pitch time between beeps and the type of visual indication depend on the alarm condition Note Beeps that indicate valid and invalid keypresses pulse beep patient data cleared and selection on Smart pulse rate alarm limits will also be heard during audible alarms There will be no upper lower alarm limit loss of pulse or sensor cable disconnect alarms if the N 3000 is turned on before the cable or SpO2 sensor is attached These alarms sound only after a pulse has been monitored Press the AUDIBLE ALARM OFF button once to silence an alarm The alarm will be turned off for an amount of time as described in Table 2 Table 2 Audible Alarm Off Duration When AUDIBLE ALARM OFF button is pressed alarm will remain off until High priority 1 Alarm silence duration setting expires Parameter outside of set 1 Alarm silence duration setting alarm limits expires or 2 A higher priority alarm occurs 50 sec after loss of pulse with continuous motion SpO 2 cable sensor 1 Thesituation is corrected then disconnect recurs or Low battery
27. any liquid on the N 3000 its accessories connectors switches or openings in the chassis Toclean the N 3000 dampen a cloth with a commercial non abrasive cleaner and wipe the top bottom and front surfaces lightly Wipe the sensor extension cable with a damp cloth F or sensors follow cleaning instructions in the directions for use accompanying the sensor If liquid is accidentally spilled on the N 3000 clean and dry thoroughly before reuse BATTERY MAINTENANCE 60 Caution If the N 3000 is to be stored for a period of 24 months or longer notify service personnel to remove the battery from the monitor prior to storage Recharge the battery when it has not been charged for 6 months or more If the N 3000 has not been used for a long period of time the battery will need charging To charge the battery connect the N 3000 to an SPS or PSS external power supply or an N 3200 which is connected to an AC outlet refer to the Setup section It may be necessary to briefly turn on the N 3000 to start battery charging Troubleshooting and Maintenance Note Storing the N 3000 for a long period without charging the battery may degrade the battery capacity A complete battery recharge requires 14 hours Ee Nellcor Puritan Bennett recommends that the N 3000 battery be replaced at 2 year intervals Refer to the N 3000 service manual for battery replacement and general service instructions OBTAINING TECHNICAL ASSIST
28. atures Nellcor Symphony Instruments in Stack Ee WARNING The N 3000 is to be operated by qualified personnel only for non prescription device Before use carefully read this manual accessory directions for use all precautionary information and specifications WARNING The N 3000 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms WARNING Pulse oximetry readings and pulse rate signals can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions WARNING For pacemaker patients the N 3000 may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias Do not rely entirely upon N 300 alarms Keep pacemaker patients under close surveillance WARNING Do not silence the audible alarm or decrease its volume if patient safety could be compromised POWER ON AND SELF TEST WARNING Ensure that the speaker is clear of any obstructions Failure to do so could result in an inaudible alarm tone 31 Start Up and Use Automatic Self Tests When the N 3000 is turned on it performs automatic self tests A 1 second beep indicates that self tests were performed successfully While in use the N 3000 performs self tests every 4 to 5 minutes without interrupting normal operation If these self tests are successful you will see no changes in the operation of the N
29. ce 3 avenue du Canada Batiment Sigma LP851 Les Ulis 91975 Courtaboeuf Cedex France Tel 33 01 69 82 14 00 Nelicor Puritan Bennett Italia Srl Via dei Tulipani 3 20090 Pieve Emanuele M1 Italy Tel 39 2 90786404 Nellcor Puritan Bennett Finland Oy Kappelitie 8 02200 Espoo Finland Tel 358 9 270 92 900 To obtain information about a warranty if any for this product contact Nellcor Puritan Bennett Technical Services or your local Nellcor Puritan Bennett 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 The following are trademarks of Nellcor Puritan Bennett Inc Durasensor Nelicor Symphony Oxisensor II Dura Y Oxismart OxiCliq and the Nellcor Puritan Bennett knob configuration Covered by one or more of the following U S Patents and foreign equivalents 4 621 643 4 700 708 4 770 179 4 653 498 5 078 136 5 351 685 4 869 254 and 5 368 026 CONTENTS Figures Tables Safety Information ccccccccecee cece eenen reenen a 1 General Safety Information cccccecceeseeeeese ceteeeeeeeeees 1 Measurements eeeeeeeeeaeeeeeeeeeseesenaees 2 N 3000 and Other Equipment eters 3 introduction ue hei nei o beaches beeline eeu DEE es 5 Intended Ulee ceneeeeeeeeeaeaeeeeseeenineeeee aaant 5 About This Manual 5 Controls I
30. ctions for use all precautionary information and specifications WARNING Pulse oximetry readings and pulse rate signals can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions CAUTION When connecting the N 3000 to any instrument verify proper operation before clinical use Both the N 3000 and the instrument connected to it must be connected to a grounded outlet Accessory equipment connected to the monitor s data interface must be certified according to IEC Standard 950 for data processing equipment or IEC Standard 601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 601 1 1 system requirements Anyone who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of system standard IEC Standard 601 1 1 Safety Information Nellcor Puritan Bennett s oxygen transducers sensors can be categorized as surface devices contacting skin for a limited duration of time Biocompatibility testing has been conducted on Nellcor Puritan Bennett s sensors in compliance with ISO 10993 1 which suggests cytotoxicity sensitization and irritation or intracutaneous reactivity testing be performed on devices falling into this category The sensors have passed the recommended biocompatibility testing and are t
31. ctrosurgical unit isin use but the readings may be inaccurate during use and shortly thereafter WARNING Disconnect the N 3000 and Nellcor sensor during magnetic resonance imaging MRI scanning Use during MRI could cause burns or adversely affect the MRI image or the monitors accuracy Also to avoid burns remove the N 3000 sensor from the patient before conducting MRI WARNING Do not lift the monitor by the sensor cable lead or power cord because the cable lead or cord could disconnect from the monitor causing the monitor to drop on the patient 17 Setup PERFORMANCE VERIFICATION The N 3000 performance can be verified by following the procedures outlined in the Performance Verification section of the N 3000 service manual Qualified service personnel should perform this procedure before using the monitor for the first time in a clinical setting CONNECTING TO AN EXTERNAL POWER SUPPLY The N 3000 may be used alone or stacked with the N 3100 blood pressure monitor the N 3200 display printer or both If connected to the N 3200 it is not necessary to connect to an external power supply If transporting the monitor or if AC power is not available you may operate the N 3000 on battery power for a limited amount of time In that case it is not necessary to connect to an external power supply CONNECTING THE N 3000 TO THE SPS POWER SUPPLY 1 Place the N 3000 on a flat surface near the patient With an optional
32. ded by Nellcor Puritan Bennett Ensure that the power available indicator on the external power supply lights 19 Setup CONNECTING THE N 3000 TO THE PSS POWER SUPPLY 1 Placethe PSS on a flat surface near the patient 2 Connect the PSS to the N 3000 as shown in Figure 10 Figure 10 Connecting to the PSS External Power Supply 3 Slidethe monitor onto the PSS until the docking connectors firmly engage and you hear a click WARNING In the USA do not connect to an electrical outlet controlled by a wall switch because the device may be accidentally turned off A PlugthePSS into an AC outlet 5 Using the PSS rear panel rocker switch turn the power supply on Ensure that the green LED on the front of the PSS is lit BATTERY OPERATION In case of loss of external power the N 3000 operates on its internal battery that provides at least 4 hours of operation from a new fully charged battery when operating independently of the N 3100 and N 3200 When operating in the stacked configuration with the N 3200 either the N 3000 battery or N 3200 battery provides power to the stack depending on which battery has the higher charge voltage When stacked with the N 3100 battery life varies depending primarily on the frequency of N 3100 blood pressure measurements Recharge the N 3000 after extensive battery use or after the BATTERY IN USE BATTERY LOW indicator has been flashing If the m
33. dure ss sssssssnesssnnsnesnneeennn meserna 32 Clearing Datared a ad N 33 Ee Contents Neonatal MOOG ss chess cccetebsanetheegecee Bieeieskia ege Dee aaar 34 Patient Trend Data cccccccseseeceeee ceeeeneeaeeeeeeseesenaeeeeess 35 FORMAL EE 35 El E 35 FOMMAat ugesi eege Edge eege eebe terest sett 35 Description Of Alarms 0 ccceeeeeeeeeeenteeeeeeceeeeeenaeeeeenaeeeeeeaes 36 Management of Loss of Pulse Alam 36 Alarm Descriptions 0 ccc eeeeeeeeeeeeeeee ceeeeeeaeeeeeaaeeeeeaas 39 All Alarm Silence cccceccccecesseceeeee ceeeesnaeeeesssaeeseeaaes 41 Latching Alarm Option cecceeesceseeeeeenee ceeeeeneeeeneees 42 Alarm SUMMARY EE 42 Adjusting Alarm Limits 20 0 0 ceceeeeeseeeeeee ceeeeeenaeeeeenaeeeeneas 43 Melen esic cadet e i ran eaea Seel duet Seege eebiei og eer 43 Selecting Alarm Limit to be Adlueted 44 Alarm Limits Changed Indicator s sesseeeeeeeeeeeeeee ee 45 Selecting Smart Pulse Rate Alarm Limits c00 45 Adjusting Audible Alarm Silence Duration 46 Shortcut to Select OFF for Audible Alarm Silence RTL E 48 Adjusting Audible Alarm Volume A 48 Audible Alarm Off Reminder ssssnnnsennnnnennnne nne naene 49 Adjusting Pulse Beep Volume nesre 50 Technical Staff Adjustable Features 0ccecssceecseee a 51 Nellcor Symphony Instruments in Stack 0 ccccceeeeeees 51 Battery Operation 51 Troubleshooting and Maintenance
34. e NEW PATIENT NEONATAL button twice within 2 seconds When the N 3000 is in neonatal mode the NEONATAL MODE indicator lights the indicator does not light when the N 3000 is in the adult pediatric mode To change back to adult pediatric mode press the NEW PATIENT NEONATAL button twice within 2 seconds The NEONATAL MODE indicator should no longer be lit Noe The default power on operating mode can be changed to the neonatal mode by qualified service personnel using the configuration mode described in the N 3000 service manual When you change operating modes adult pediatric to neonatal or vice versa alarm limits return to power on defaults for the respective modes and previous patient data is cleared from the displays When the N 3000 is stacked with the N 3100 the initial power on default operating mode may be different for the two instruments Both instruments in the stack should be in the same operating mode neonatal or adult pediatric If active instruments in the stack arein different operating modes when power is turned on press the NEW PATIENT NEONATAL button twice 2 presses within 2 seconds on the active instrument that is in the incorrect mode as needed to place all active instruments in the same operating mode Note The default power on operating mode can be changed by technically qualified service personnel using the configuration mode described in the service manual for the instrument needing to be changed
35. etect at least one qualified pulse during any 10 second period it enters pulse search mode the PULSE SEARCH indicator lights the displays alternate between data and dashes and the data evaluation period starts During the 50 second data evaluation period e Ifthe patient is not moving for example because of cardiac arrest shock paralysis anesthesia and has no qualified pulse for 6 seconds a high priority alarm immediately sounds the PULSE SEARCH indicator flashes and the data displays flash zeroes e Ifthe patient is constantly moving the N 3000 searches for qualified pulses for up to 50 seconds Each timea qualified pulse is detected even during motion the data displays are updated The N 3000 returns to normal operation as soon as it detects one of the following three consecutive qualified pulses when there is no motion five consecutive qualified pulses when thereis motion or a total of 10 qualified pulses Otherwise at the end of the data evaluation period the data displays flash zeroes and if motion is still present a low priority alarm sounds if there is no motion a high priority alarm sounds If during the 50 second data evaluation period motion stops and no qualified pulse is found for 6 seconds a high priority alarm sounds immediately Start Up and Use N 3000 loss of pulse alarm management can therefore be considered a three tier system Normal mode during which qualified pulses are being
36. fal NELLCOR PURITAN BENNETT OPERATOR S MANUAL Nellcor Symphony N 3000 Pulse Oximeter Caution Federal law U S restricts this device to sale by or on the order of a physician To contact Nellcor Puritan Bennett s representative In the United States call 1 800 NELLCOR or 510 463 4000 outside of the United States call your local Nellcor Puritan Bennett representative 1997 Nellcor Puritan Bennett Inc All rights reserved 035502A 1097 Corporate Headquarters Nelicor Puritan Bennett Inc 4280 Hacienda Drive Pleasanton California 94588 USA Tel 510 463 4000 1 800 NELLCOR European Office Nellcor Puritan Bennett Europe BV Hambakenwetering 1 5231 DD s Hertogenbosch The Netherlands Tel 31 73 6485200 Asia Pacific Office Nellcor Puritan Bennett HK Ltd Room 1602 Evergo House 38 Gloucester Road Wanchai Hong Kong Tel 852 2529 0363 Latin American Office Nelicor Puritan Bennett Inc 1750 University Drive Suite 216 Coral Springs Florida 33071 USA Tel 954 346 7977 Regional Local Offices Nellcor Puritan Bennett UK Ltd 10 Talisman Business Centre London Road Bicester Oxfordshire OX6 OJ X United Kingdom Ted 44 1869 322700 Nellcor Puritan Bennett Germany GmbH Black amp Decker Strasse 28 65510 Idstein Germany Tel 49 6126 5930 Nellcor Puritan Bennett Belgium NV SA Interleuvenlaan 62 8 Zone 2 B 3001 Heverlee Belgium Tel 32 16 400467 Nellcor Puritan Bennett Fran
37. fault values if necessary as described below Changes you make will remain in effect until you change them again or turn the N 3000 off WARNING Each time the monitor is used check alarm limits to ensure that they are appropriate for the patient being monitored 43 Start Up and Use When monitored patient values appear in the digital displays or dashes are displayed before a measurement is taken the N 3000 is in normal patient monitoring mode When either the UPPER or the LOWER ALARM LIMIT button is pressed the N 3000 is in view adjust alarm limits mode While in the view adjust alarm limits mode current alarm limits will be displayed but patient parameter values will not be displayed The N 3000 automatically returns from view adjust alarm limits mode to normal mode if you do not press a limit button or adjust a setting within 3 seconds It also returns to normal mode if you press the AUDIBLE ALARM OFF or NEW PATIENT NEONATAL button Any alarm limit changes made will take effect Selecting Alarm Limit to be Adjusted To select an upper alarm limit to view or adjust press the UPPER ALARM LIMIT button When the UPPER ALARM LIMIT button is pressed the upper alarm limit for SpO2 is displayed Subsequent pressing of the UPPER ALARM LIMIT button will cycle through the displays showing upper alarm limit for pulse rate and back again to the SpO2 display The display of an upper alarm limit is indicated by dashes in the u
38. fter the displayed parameter value during patient monitoring or when alarm limits are viewed The decimal point remains until you change modes adult or neonatal turn the N 3000 off or until the value is adjusted back to the default value SELECTING SMART PULSE RATE ALARM LIMITS The Smart feature automatically sets pulse rate alarm limits as follows e Lower Alarm Limit 75 of the patient s current pulse rate at time of setting or 30 bpm whichever is larger e Upper Alarm Limit 150 of the patient s current pulse rate or 250 bpm whichever is smaller For example if the patient s pulse rate is 80 bpm when you select the Smart feature the upper alarm limit would be set at 120 bpm and the lower limit would be set at 60 bpm Note Smart pulse rate alarm limits can be set only when the N 3000 is displaying a pulse rate value other than zero 45 Start Up and Use Figure 17 Selecting Smart Pulse Rate Alarm Limits To select Smart pulse rate alarm limits press and hold the UPPER and LOWER ALARM LIMIT buttons simultaneously for 3 seconds as shown in Figure 15 Three beeps indicate that the new limits are set based on a valid pulse A single invalid keypress beep after the 3 seconds indicates that Smart pulse rate alarm limits were not set for lack of a qualified pulse Once Smart pulse rate alarm limits are activated alarm limits will not change unless one of the following occurs e
39. gs may have returned to power on defaults due to an internal instrument reset Turn the instrument off and back on again Check and if necessary readjust alarm limits Notify service personnel if it is necessary to reconfigure power on defaults EEE 058 Alarm and beep volume audible alarm silence duration and operating mode may have returned to power on defaults due to an internal instrument reset Turn the instrument off and back on again Check and if necessary readjust alarm and pulsatile beep volume setting audible alarm silence duration and operating mode Notify service personnel if it is necessary to reconfigure power on defaults EEE 081 The N 3000 is unable to interface with the sensor Check the sensor and SCP 10 cables and the connections To clear the error disconnect and reconnect the sensor If the error code remains replace the sensor and or the cable If the error code still persists notify service personnel Error Conditions 54 L A pulsing shrill alarm sounds and the N 3000 does not start up e Thereis no power available to the N 3000 Press the AUDIBLE ALARM OFF button to stop the alarm The battery has discharged below the shutdown point and either AC power is not available or the external power supply has failed Notify your service personnel e The ON STANDBY button may be inoperable in which case the N 3000 may attempt to restart until the battery is discharged or removed
40. herefore in compliance with I SO 10993 1 Measurements If the accuracy of any measurement does not seem reasonable first check the patient s vital signs by alternate means and then check the N 3000 for proper functioning Inaccurate measurements may be caused by e incorrect sensor application or use e significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin e intravascular dyes such as indocyanine green or methylene blue e exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight e excessive patient movement e venous pulsations e placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line You can continue to use the N 3000 on a patient during defibrillation but the readings may be inaccurate for a short time Safety Information Loss of pulse signal can occur in any of the following situations e the sensor is too tight Ee e there is excessive illumination from light sources such as a surgical lamp a bilirubin lamp or sunlight e ablood pressure cuff is inflated on the same extremity as one to which an SpO2 sensor is attached e the patient has hypotension severe vasoconstriction severe anemia or hypothermia e thereis arterial occlusion proximal to the sensor e the patient isin cardiac arrest
41. icated to the alarm active function and patient data will not be available Refer to the N 3000 service manual Setup The alarm active function also located in the serial port connector may be used to monitor N 3000 alarms from a remote location The alarm active function remains active whether the monitor is operating from an AC source or the internal battery The alarm active function allows use of a nurse call light Alarm monitoring also applies to an attached active N 3100 or N 3200 Refer to the N 3000 service manual for information concerning the required serial port configuration to activate the alarm active function ysi 6uR WARNING The alarm active function will not be activated by alarms from other stacked instruments unless all instruments are communicating with each other For proper operation verify that the STACKED indicator on each stacked instrument is on WARNING The nurse call feature should not be used as the primary source of alarm notification The audible and visual alarms of the N 3000 monitor used in conjunction with clinical signs and symptoms are the primary sources for notifying medical personnel that an alarm condition exists 25 SENSORS AND ACCESSORIES Selecting a Nellcor Puritan Bennett Sensor Biocompatibility Testing Connecting SpO2 Sensors Sensor Performance Considerations Ee WARNING Use only one extension cable to increase the length of the sensor Use of more than one
42. iority alarm sounds PULSE SEARCH PULSE SEARCH indicator flashes indicator lights continuously SpO2 and pulse rate SpO2 and pulse rate flashes zeros alternates between previous display and dashes oO 0 seconds 10 seconds 16 seconds 60 seconds 6 seconds 50 seconds It during motion the N 3000 detects a qualified pulse the values on the display are updated If motion stops at any time during the pulse search mode and no qualified pulse is detected the high priority alarm will immediately sound after 6 seconds Figure 16 Monitoring Conditions and Alarm Responses 37 Start Up and Use 38 When an N 3000 is stacked with an N 3100 blood pressure monitor and the N 3100 begins a blood pressure measurement the N 3000 is notified Blood perfusion at the SpO 2 sensor on the same limb as an N 3100 blood pressure cuff will be momentarily interrupted during a blood pressure measurement Therefore an N 3000 stacked with an N 3100 will be inhibited from producing a loss of pulse alarm when the N 3100 begins a blood pressure measurement This happens even if the N 3000 SpO 2 sensor and the N 3100 blood pressure cuff are on different extremities The N 3000 will resume monitoring for loss of pulse after the N 3100 has completed its measurement including any needed measurement re attempts The N 3000 manages Ioss of pulse alarms as follows and as illustrated in Figure 16 If the N 3000 fails to d
43. larm Silence Duration to Off When operating in the stacked configuration using the shortcut method to set the N 3000 audible alarm silence duration to OFF does not affect the audible alarm silence duration of other instruments in the stack To return to the previous alarm silence duration selection or to the power on default if no change was made simultaneously press the AUDIBLE ALARM OFF button and the LOWER ALARM LIMIT button ADJUSTING AUDIBLE ALARM VOLUME 48 To adjust the audible alarm volume for alarms other than microprocessor and power failure press and hold the AUDIBLE ALARM OFF button for at least 3 seconds without turning the knob or pressing any other buttons until you hear a tone Observe the audible alarm volume range expressed in a value from 1 to 10 in the AUXILIARY display A 1 represents the lowest volume and a 10 represents the highest volume setting Turn the control knob to adjust the volume Sp02 PULSE RATE min L decl s Start Up and Use When operating in the stacked configuration the audible alarm volume level setting for each instrument remains as it was before being stacked Setting the audible alarm volume on one active instrument in a stack sets the audible alarm volume on any other active instrument in the stack to the same level Ee Audible Alarm Off Reminder An audible alarm off reminder sounds three beeps at 3 minute intervals when the audible alarm silence duratio
44. larm limits When used by itself the knob adjusts pulse beep volume on the N 3000 It is also used with other controls to adjust alarm limits audible alarm silence duration and alarm volume DESCRIPTION OF VISIBLE INDICATORS AND DISPLAYS 12 Sp02 E E E E PULSE RATE min OQ min PULSE SEARCH or MOTION or d The Sp02 display shows patient arterial hemoglobin oxygen saturation level It is updated with each pulse The Sp02 display flashes and an alarm sounds when Sp0O2 is outside the alarm limits During Pulse Search the display will alternate between dashed lines and the last qualified oxygen saturation measurement The PULSE AMPLITUDE indicator is a 10 segment display that shows the relative pulse amplitude The bottom segment remains lit as long as an SpO2 cable and SpO2 sensor are connected to the N 3000 As the detected pulse becomes stronger more contiguous segments light with each pulse The PULSE RATE display shows the pulse rate in beats per minute It is updated with each pulse It flashes and an alarm sounds when the pulse rate is outside the alarm limits During pulse search the display alternates between dashed lines and the last detected pulse rate If the detected pulse is lost a flashing zero is displayed and an alarm sounds The PULSE SEARCH indicator lights during power up prior to initial acquisition of a pulse signal and during pulse search mode The
45. mits Audible alarm volume Audible alarm silence duration Pulse beep volume Serial port baud rate Trend format Values that can be adjusted in the service mode include the following e Alarm silence reminder e Alarm latching NELLCOR SYMPHONY INSTRUMENTS IN STACK 50 When NdIcor Symphony N 3000 and N 3100 or N 3200 instruments are connected together or stacked certain functions are shared Active instruments are those that are connected together and are on e TheAUDIBLE ALARM OFF button on any active instrument silences the current audible alarm on all active instruments in the stack However only the AUDIBLE ALARM OFF button on the N 3000 is accessible when the instruments are stacked e Changing the audible alarm silence period and alarm volume on one instrument in the stack will affect all active instruments in the stack unless using the shortcut method described previously in this section e When an instrument is added to a stack of instruments it will retain its audible alarm silence period and alarm volume settings until manually changed Start Up and Use During operation when the operating mode neonatal or adult pediatric is adjusted on one instrument all active instruments in the stack are automatically set to that mode The knob on the N 3000 may be used to perform adjustments on the N 3100 or N 3200 when a knob related function is activated Ee One Nellcor Puritan Bennett external powe
46. n has been set to OFF The AUDIBLE ALARM OFF indicator continues to flash until the silence duration is changed The volume of the audible alarm off reminder is equal to the alarm volume setting or if stacked with another instrument equal to the highest current audible alarm volume setting for any active instrument in the stack Note Theaudible alarm off reminder may be disabled using the service mode as indicated in the N 3000 service manual ADJUSTING PULSE BEEP VOLUME The N 3000 beeps with each detected pulse The beep pitch varies proportionately with percentage of saturation rising as SpO 2 increases toward 100 and falling as it decreases EN Whilein normal patient monitoring mode turn E the knob to adjust pulse beep volume When the N 3000 is turned off and back on again the pulse beep returns to its power on default volume Pulse beeps will continue during an audible alarm 49 Start Up and Use TECHNICAL STAFF ADJUSTABLE FEATURES When the N 3000 is placed in the configuration mode by qualified service personnel they may adjust power on default values of N 3000 features Instructions for activating the configuration and service modes and making these adjustments are found in the N 3000 service manual Power on default values that can be adjusted or set in the configuration mode include the following Operating mode adult or neonatal SpO 2 upper and lower limits Pulse rate upper and lower li
47. ndicators and Symbols 00aaaaaanaaaaaaaena aaaea 7 Displays Controls Indicators and Connectors 7 N 3000 Symbols AAA EE 10 Rear Kamelle ereeschen Eed 10 Right Side Panel 11 SPS External Power Supply Symbols c cceeeeeeees 11 Description Of Controls ccccceeeeeeeeeeeeeee eeeeeeeeeeeeeeeeeeaees 11 Description of Visible Indicators and Displays 0 10020 12 Description of Audible Indicators eeeenaes 15 Setup E 17 Performance Verification cccccccscceeceeee ceeseeteeeeeeeeeeees 18 Connecting to an External Power Supply sssesseesseeseee 18 Connecting the N 3000 to the SPS Power Supply 18 Connecting the N 3000 to the PSS Power Supply 20 Battery Operation ccccceececeeeceeeeeee caeeeeeeeeseeeesaeeeeeeteaes 20 Stacking with the N 3100 or N 3200 es 21 Connecting the N 3000 to the N 3100 orhN 2200 21 Removing the N 3000 From the N 3100 or N 3200 23 Serial NGM ACCS wc haveccewesttsctesand capchor Seed EE 24 Sensors and Accessories ceeeeteeeteneeeeaees 27 Selecting a Nellcor Puritan Bennett Sensor nssnasnanaaens 28 Biocompatibility Testing ec eeeeeeeeeesneeeee caeeeeeenaeeeeeeaaes 28 Connecting SpO2 Sensors ceeeeeessteeeees 29 Performance Considerations sesseeeeeeees 30 Start Up and Use eee eeee ce eeeeeeeeeeeeeeeseeeeeaeeeeaas eee 31 Power On and Get Test 31 Automatic Get Tests 32 N 3000 Turn On Proce
48. ns are based on testing the subject monitor on healthy adult volunteers in induced hypoxia studies across the specified range Adult accuracy is determined with Oxisensor II D 25 sensors Neonatal accuracy is determined with Oxisensor N 25 sensors In addition the neonatal accuracy specification is adjusted to take into account the theoretical effect of neonatal blood on oximetry measurements Pulse Rate 20 250 bpm 3 bpm 67 Specifications ENVIRONMENTAL CONDITIONS Transport and Storage in shipping container Temperature 40 C to 70 C 40 F to 158 F Altitude B arometric Pressure 390 m to 6 096 m 1 280 ft to 20 000 ft 1 060 hPa to 500 hPa 31 3 in Hg to 14 in Hg Relative Humidity 15 relative humidity to 95 relative humidity noncondensing Transport and Storage not in shipping container Temperature 20 C to 60 C 4 F to 140 F Altitude B arometric Pressure 390 m to 6 096 m 1 280 ft to 20 000 ft 1 060 hPa to 500 hPa 31 3 in Hg to 14 in Hg Relative Humidity 15 relative humidity to 95 relative humidity noncondensing Operation 68 Temperature 5 C to 40 C 441 F to 104 F Altitude B arometric Pressure 390 m to 43 048 m 1 280 ft to 10 000 ft 1 060 hPa to 700 hPa 31 3 in Hg to 20 6 in Hg Relative Humidity 15 relative humidity to 95 relative humidity noncondensing APPENDIX PRINCIPLES OF OXIMETRY Pulse Oximetry O
49. nt Button Battery in Use Battery Low Indicator Battery Charging Indicator Linked Indicator RF Lock Indicator Lower Alarm Limit Button Upper Alarm Limit Button Leads Off Indicator Pulse Search Indicator Patient Motion Indicator Controls Indicators and Symbols 20 19 18 17 16 151413 1211 10 Figure 2 N 3000 Front Panel International 1 SpO2 Display 11 2 Pulse Amplitude Indicator 12 3 ECG Heart Rate Indicator 13 4 Pulse Rate Display 14 5 Auxiliary Display 15 q 16 7 Audible Alarm Off Indicator 17 8 On Standby Button 18 9 Power On Indicator 19 10 Stacked Indicator 20 Not used on this model New patient and neonatal adult pediatric mode button Print Button Battery in Use Battery Low Indicator Battery Charging Indicator Linked Indicator RF Lock Indicator Lower Alarm Limit Button Upper Alarm Limit Button Leads Off Indicator Pulse Search Indicator Patient Motion Indicator Serial interface connector Figure 3 N 3000 Rear Panel Controls Indicators and Symbols SpO2 cable connector SCP 10 Ee W A CONNECTIONS ELECTRICALLY ISOLATED External power supply or docking connector Figure 4 N 3000 Right Side Panel North American SpO2 cable connector SCP 10 External power supply or docking connector Figure 5 N 3000 Right Side Panel International Controls
50. o those from an instrument that measures fractional saturation fractional measurements must be converted as follows s fractional saturation functional saturation x100 100 carboxyhemoglobin methemoglobin Appendix Principles of Oximetry MEASURED VERSUS CALCULATED SATURATION When arterial saturation SpOz 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 derived from a blood gas analyzer was not appropriately corrected for the effects of variables that shift the relationship between PO2 and saturation Figure A 1 pH temperature the partial pressure of carbon dioxide PCO 2 2 3 DPG and fetal hemoglobin t pH EE Temperature X T Ee 100 PCO2 2 3 DPG Fetal Hb E lt pH 2 50 S Temperature H PCO2 E 2 3 DPG on 50 100 PO2 mmHg Figure A 1 Oxyhemoglobin Dissociation Curve A 3
51. onitor is not recharged the monitor may fail to operate or stop operating suddenly 20 Setup When the N 3000 is connected to an external power supply or is Stacked with an N 3200 connected to AC power or stacked with an N 3100 connected to an active SPS or PSS external power supply the self contained battery automatically recharges whether the N 3000 is on or off A complete recharge of a fully drained battery requires 14 hours Ee STACKING WITH THE N 3100 OR N 3200 If you wish to operate in the stacked configuration use the following instructions to connect the N 3000 to the N 3100 or N 3200 These procedures assume that you have read the appropriate N 3100 or N 3200 operator s manual When operating stacked with the N 3100 ensure that both instruments are in the same operating mode neonatal or adult pediatric and check all configurable settings If the active instruments in the stack are in different operating modes when power is turned on press the NEW PATIENT NEONATAL button on any of the active instruments twice two presses within 2 seconds as needed to place all active instruments in the same operating mode CONNECTING THE N 3000 TO THE N 3100 OR N 3200 The N 3000 must be the top unit in the stack 1 Connect the external power supply and power cable to the N 3100 as indicated in the N 3100 operator s manual If stacking with the N 3200 plug the power cord directly into the power input connector on
52. or 2 A higher priority alarm occurs microprocessor power failure Start Up and Use If the alarm condition ceases prior to the end of the alarm silence duration the AUDIBLE ALARM OFF indicator is extinguished While the condition exists the indicator remains lit for the duration of the selected alarm silence period or until a higher priority alarm condition arises in which case the AUDIBLE ALARM OFF indicator goes out and an alarm sounds Ee If the audible alarm silence duration is set to OFF the AUDIBLE ALARM OFF indicator flashes and no audible alarms will occur except those for low battery power or microprocessor failure and sensor or sensor cable disconnect Silence duration selection including OFF does not affect low battery power or microprocessor failure or sensor or sensor cable disconnect alarms All Alarm Silence Theall alarm silence feature is available only in models with a software version of 3 4 3 or later Qualified service personnel can determine the software version using the procedures in the configuration mode section of the service manual Press the AUDIBLE ALARM OFF button twice within 2 seconds to silence all alarms for the alarm silence duration whether an alarm is currently sounding or not Three beeps indicate that this feature has been activated and the AUDIBLE ALARM OFF indicator lights continuously until the end of the alarm silence duration The all alarm silence mode is automatically exited
53. or is in shock N 3000 and Other Equipment When connecting the N 3000 to any instrument verify proper operation before clinical use Refer to the other device s manual for full instructions Accessory equipment connected to the monitor s data interface must be certified according to IEC Standard 950 for data processing equipment or IEC Standard 601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 601 1 1 systems requirements Anyone who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of system standard IEC Standard 601 1 1 If in doubt consult Nellcor Puritan Bennett s Technical Services Department or your local Nellcor Puritan Bennett representative Noninvasive blood pressure monitors may interrupt N 3000 pulse rate measurements creating false alarms A stacked N 3100 Nellcor Symphony blood pressure monitor informs the N 3000 of an inflation in progress reducing the likelihood of false alarms It is recommended that only a stacked N 3100 blood pressure monitor be used with the N 3000 INTRODUCTION Intended Use About this Manual INTENDED USE The purpose and function of the Nellcor Symphony N 3000 pulse oximeter is to continuously and noninvasively measure functional arterial oxygen saturation of arterial hemoglobin SpO2 and pulse rate
54. or leads to a new site The sensor may be damp or may have been reused too many times replace it An electrosurgical unit ESU may be interfering with performance Move the N 2000 cables and sensor as far from the ESU as possible Plug the N 3000 power supply and the ESU into different AC circuits MovetheESU ground pad as close to the surgical site as possible and as far away from the sensor as possible 5 Displayed SpO2 pulse rate does not correlate with that of an ECG monitor connected to the patient The patient may have a dysrhythmia All beats counted by the ECG monitor may not be perfused Excessive patient motion may be making it impossible for the N 3000 to acquire a good pulse signal If possible keep the patient still check whether the sensor is applied securely and properly and replace if necessary move the sensor to a new site The patient may have a pronounced dicrotic notch which could cause the pulse rate measurement to double Try another sensor site Troubleshooting and Maintenance e An ESU may be interfering with performance Refer to the discussion above e Interference artifact or patient motion may be affecting the accuracy of the ECG monitor ysi 6uR 6 Oxygen saturation SpO2 measurement does not correlate with the value calculated from a blood gas determination e Calculated saturation values are inherently and slightly different from pulse oximeter measurements
55. pment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help 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 Inspec the safety relevant labels for legibility 59 Ee Troubleshooting and Maintenance SERVICE The N 3000 requires no routine maintenance other than cleaning battery maintenance and that which is mandated by your institution If the monitor has been visibly damaged or subjected to mechanical shock for example when dropped qualified service personnel should perform the procedure in the Performance Verification section of the service manual If problems cannot be corrected by your service personnel the N 3000 should be returned to Nellcor Puritan Bennett for service Contact Nellcor Puritan Bennett s Technical Services Department or your local representative for return instructions CLEANING WARNING Do not spray pour or spill
56. pper portion of the displays that are not selected An example of a pulse rate upper alarm limit is shown below Sp02 PULSE RATE min To select a lower alarm limit press the LOWER ALARM LIMIT button When the LOWER ALARM LIMIT button is pressed the lower alarm limit for SpO2 is displayed Pressing of the LOWER ALARM LIMIT button again whilein the view adjust alarm limits mode will display the lower alarm limit for pulse rate and back to the SpO2 display when pressed again The display of a lower alarm limit is indicated by dashes in the lower portion of the displays that are not selected An example of a pulse rate lower alarm limit is shown below Sp02 PULSE RATE min E USCH Start Up and Use If the LOWER ALARM LIMIT button is pressed while an upper alarm limit is displayed the lower alarm limit for that parameter will then be displayed ysi 6uR While the upper alarm limit or the lower alarm limit is displayed and before 3 seconds have elapsed turn the knob on the top of the N 3000 to adjust the displayed alarm limit Note Ifthe SpO2 limits are set to their minimum 20 or maximum 100 values the SpO2 alarm is disabled and will not sound However if the pulse rate limits are set to their maximum 250 bpm or minimum 30 bpm the alarms are enabled and will alarm normally Alarm Limits Changed Indicator Sporx If alarm limits have been changed from the N 3000 s power on defaults a decimal point will appear a
57. r supply connected to AC power can supply power to the N 3000 and N 3100 If the N 3200 is used it can be directly connected to AC power and provide power to any combination of stacked instruments Pressing the NEW PATIENT NEONATAL button for 3 seconds on either the N 3000 or N 3100 clears data for both active instruments in the stack When the N 3100 is connected to the N 3000 it informs the N 3000 of blood pressure cuff inflation The N 3000 may then correctly process pulse signals affected by cuff inflation to prevent a nuisance alarm N 3000 SpO2 alarms will be silenced for the entire time the N 3100 is taking a blood pressure measurement When the N 3000 is connected to the N 3200 the N 3000 provides data for plethysmographic waveforms The N 3000 also provides SpO2 percentage pulse rate and pulse amplitude for display in a tabular format on the N 3200 When the N 3000 is connected to the N 3100 the initial power on default operating mode may be different for the two instruments Both instruments in the stack should be in the same operating mode neonatal or adult pediatric If the active instruments in the stack are in different operating modes when power is turned on press the NEW PATIENT NEONATAL button twice 2 presses within 2 seconds on the active instrument that is in the incorrect mode as needed to place all active instruments in the same operating mode Note The power on default operating mode can be
58. remains lit as long as the N 3000 is powered on and connected to a sensor cable and SpO2 sensor Other segments may light briefly Ee While the SpO2 cable with sensor is attached to the monitor or any time the N 3000 is attempting to acquirea pulse signal the first and third first and fifth or first and seventh segments of the pulse amplitude indicator may light briefly as shown below UNI a DR RR Q UD If the SpO2 cable with sensor is attached to the monitor but not attached to the patient when you first power up the N 3000 the SpO2 and PULSE RATE displays indicate 0 Sp02 PULSE RATE min Note Other combinations for example the SpO2 cable without sensor will result in different initial displays CLEARING DATA Caution Pressing and holding the NEW PATIENT NEONATAL button 3 seconds or more until three beeps sound clears all previously stored patient data If the N 3000 is being applied to a new patient press and hold the NEW PATIENT NEONATAL button for 3 seconds until you hear three beeps to indicate that stored patient data is cleared Alarm limits are not affected 33 Start Up and Use NEONATAL MODE 34 WARNING Each time the monitor is used check alarm limits to ensure that they are appropriate for the patient being monitored The default power on mode set at the factory is the adult pediatric mode To change the N 3000 from the adult pediatric mode to the neonatal mode press th
59. se is lost because of deteriorating patient condition the oximeter should alarm quickly However normal interference can obscure the pulsatile signal If interference is short lived no alarm should sound Such alarms are distracting and potentially time consuming However if interference persists an alarm should notify the attendant The N 3000 loss of pulse alarm is designed for use in environments in which the pulse can be obscured by interference Most loss of pulse alarms are attributable to interference from patient motion which typically is brief When the pulsatile signal is lost the N 3000 s ability to identify interference from motion becomes particularly important because the response of the monitor is determined by the presence or absence of interference from patient motion Start Up and Use Because a spontaneously moving patient can be assumed to have a pulse as long as continuous motion is detected the N 3000 continues to search for the pulse m J Qe SPORADIC OR LOST PULSE WITH CONTINUOUS MOTION e Low priority alarm sounds PULSE SEARCH indicator lights continuously PULSE SEARCH indicator flashes SpO 2 and pulse rate Data display alternates between previous flashes zeros display and dashes MOTION indicator lights continuously 0 seconds 10 seconds 16 seconds 60 seconds m 6 seconds gt 50 seconds SPORADIC OR LOST PULSE WITHOUT CONTINUOUS MOTION High pr
60. sensor extension cable may have an adverse effect on performance Do not attach to the sensor port any cable that is intended for computer use WARNING Before use carefully read the sensor directions for use including all warnings cautions and instructions WARNING Do not use a damaged sensor such as one with exposed optical components WARNING Use only Nellcor Puritan Bennett sensors and sensor cables with this monitor Other sensors or sensor cables may cause improper N 3000 performance WARNING Tissue damage can be caused by incorrect application or duration of use of an SpO2 sensor Inspect the sensor site periodically as directed in the sensor directions for use WARNING Pulse oximetry readings and pulse rate signals can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions 27 Sensors and Accessories SELECTING A NELLCOR PURITAN BENNETT SENSOR When selecting a sensor consider the patient s weight and activity the adequacy of perfusion the available sensor sites the need for sterility and the anticipated duration of monitoring For more information refer to Table 1 or contact your local Nellcor Puritan Bennett representative Table 1 Compatible Nellcor Puritan Bennett Sensors Oxygen Transducer Model Patient Size Oxisensor I1 oxygen transducer sterile single use 3 to 20 kg 10 to 50 kg gt 30 kg gt 50 kg Oxiband
61. sors and Accessories describes Nellcor Puritan Bennett sensors and accessories used with the monitor Start up and Use explains how to operate the monitor Troubleshooting and Maintenance provides information about servicing the monitor and obtaining technical assistance Specifications lists technical specifications for the monitor default alarm limit settings and performance ranges Appendix Principles of Oximetry presents a clinical explanation of the how pulse oximetry works CONTROLS INDICATORS AND SYMBOLS Displays Controls Indicators and Connectors N 3000 Symbols SPS External Power Supply Symbols Description of Controls Description of Visible Indicators and Displays Description of Audible Indicators Ee DISPLAYS CONTROLS INDICATORS AND CONNECTORS Figures 1 through 5 show the front rear side and top views of the N 3000 and identify displays controls and connectors E LI ttt HULSE RA min N PULSE SEARCH 1 woar E3 18 17 1615 14131211 10 Figure 1 N 3000 Front Panel North American SpO02 Display Pulse Rate Display Auxiliary Display Neonatal Mode Indicator On Standby Button Power On Indicator Stacked Indicator OANOARWD CH Not used on this model Pulse Amplitude Indicator ECG Heart Rate Indicator Audible Alarm Off Indicator 11 12 13 14 15 16 17 18 19 20 Pri
62. stablished Controls Indicators and Symbols DESCRIPTION OF AUDIBLE INDICATORS Audible indicators listed previously in this section have symbols associated with them The following list represents tones for which there is no accompanying symbol or button Valid keypress Invalid keypress Power on self tests passed Smart Pulse Rate Alarm Limits Set Pulse beep Ee 1 high pitched beep 1 low pitched beep 1 one second medium pitched beep 3 medium pitched beeps Beeps that are synchronous with each measured pulse 15 SETUP Performance Verification Connecting to an External Power Supply Connecting the N 3000 to the SPS Power Supply Connecting the N 3000 to the PSS Power Supply Battery Operation Stacking with the N 3100 or N 3200 Connecting the N 3000 to the N 3100 or N 3200 Removing the N 3000 from the N 3100 or N 3200 Serial Interface Ee WARNING In the USA do not connect to an electrical outlet controlled by a wall switch because the device may be accidentally turned off WARNING Do not subject the N 3000 to extreme moisture such as direct exposure to rain Such exposure may cause inaccurate performance or device failure WARNING As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation WARNING The N 3000 is not defibrillator proof However it may remain attached to the patient during defibrillation or while an ele
63. tery is in use When 15 minutes or less battery capacity remains the indicator flashes and a medium priority alarm sounds 13 Controls Indicators and Symbols 14 WARNING If the unit is turned off while the BATTERY IN USE BATTERY LOW indicator is flashing and then turned on again without recharging the indicator may take up to 30 seconds to begin flashing even though the battery has less than 15 minutes of use left Always recharge the battery after turning off an N 3000 with a flashing PRINT BATTERY IN USE BATTERY LOW indicator The BATTERY CHARGING indicator is always lit when the N 3000 is connected to AC power and turned on When the N 3000 is connected to AC power and the monitor is turned off the BATTERY CHARGING indicator will remain lit for approximately 14 hours and then turns off If there are any power interruptions the 14 hour charging period begins again when power is restored An illuminated BATTERY CHARGING indicator is not necessarily an indication that the battery contains less than a full charge It is merely used as a timer to indicate that the battery has been continuously charging for less than 14 hours The N 3000 may be used with a less than fully charged battery but with a corresponding decrease in operating time from that charge The STACKED indicator lights when the N 3000 is stacked with the N 3100 the N 3200 or both and communication between the instruments is e
64. the effects of nonpulsatile absorbers such as tissue bone and venous blood ysi 6uR Appendix Principles of Oximetry AUTOMATIC CALIBRATION 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 manufacturing the mean wavelength of the red LED is encoded in a resistor in the sensor During monitoring the instrument s software reads this resistor and selects coefficients that are appropriate for the wavelength of that sensor s red LED these coefficients are then used to determine SpO 2 This resistor is read when the monitor is turned on periodically thereafter and each time a new sensor is connected Additionally to compensate for differences in tissue thickness the intensity of the sensor s LEDs are adjusted automatically FUNCTIONAL VERSUS FRACTIONAL SATURATION A 2 This monitor measures functional saturation oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen It does not detect significant amounts of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin In contrast CO oximeters such as the L 482 report fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin including measured dysfunctional hemoglobins To compare functional saturation measurements t
65. the previous 5 days If an alarm occurs anytime during that period it is recorded Format 3 Patient data is sampled for 5 seconds and the last measurement during that period is recorded Trend data is available for the last 12 hours of actual monitoring during the previous 5 days An alarm is recorded only if the alarm was active during the last measurement 35 Start Up and Use The sample period for all three formats does not necessarily have to be continuous When the N 3000 is removed from the patient the sample period is stopped and then continued when the N 3000 is again applied to the patient For all three formats however any sample data that is over 5 days old is discarded Note Only the data from the last format used is available For example if format 1 was used continuously for an hour then format 2 was used for 2 hours only the 2 hours of format 2 data is available DESCRIPTION OF ALARMS Management of Loss of Pulse Alarm 36 Nalcor Symphony N 3000 Oxismart signal processing is designed to reduce the adverse effects of normal interference associated with motion low patient perfusion and spurious electrical or optical signals Figure 16 illustrates monitor response in sporadic or lost pulse situations with and without continuous motion Loss of pulse presents an alarm management challenge for any oximeter sometimes it is caused by a clinical emergency sometimes by signal distortion When the pul
66. verview Automatic Calibration Functional versus Fractional Saturation Measured versus Calculated Saturation PULSE OXIMETRY OVERVIEW The N 3000 uses pulse oximetry based on two principles that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light i e spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse e plethysmography A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low voltage light emitting diodes LEDs 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 monitor uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood enters the arteriolar bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The monitor bases its Sp02 measurements on the difference between maximum and minimum absorption i e measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating
67. volume setting of 4 62 5 dB A at 1 meter volume setting of 5 60 seconds On Off 19 200 bits per second 10 second averaged format 1 The PULSE RATE display updates in less than 2 5 seconds with a 1 second change in SpO2 derived pulse rate from 30 pulses per minute ppm to 200 ppm Alarm Limit Range Adult Pediatric and Neonate SpO 2 Upper Alarm Limit SpO 2 Lower Alarm Limit Pulse Rate Upper Alarm Limit Pulse Rate Lower Alarm Limit 66 20 100 20 100 30 250 bpm 30 250 bpm Specifications Alarm Characteristics Audible Characteristics Ee Pulse Repetition Alarm Pitch Pulse Width Interval Priority 30 Hz 20 msec 20 msec High oz Medium nm Low 500 Hz 3600 msec Rise fall time for pulses is 16 milliseconds 3 milliseconds Flashing Display Characteristics During high or medium priority alarms the 5 inch red front panel display with a parameter outside the alarm limits flashes at the following rates High priority 300 milliseconds ON 150 milliseconds OF F Medium priority 750 milliseconds ON 600 milliseconds OF F Accuracy SpO2 Adults 70 100 2 digits 0 69 unspecified Neonatal 70 100 3 digits 0 69 unspecified Accuracies are expressed as plus or minus X digits saturation percentage points between saturations of 70 100 This variation equals plus or minus one standard deviation 1SD which encompasses 68 of the population All accuracy specificatio
68. y when it has not been charged for 6 months or more Caution Follow local government ordinances and recycling instructions regarding disposal or recycling of device components including batteries TROUBLESHOOTING AND MAINTENANCE Troubleshooting D EMI Interference oy Compliance with Test Limits for a Class B Digital Devece e Periodic Safety Checks Service Obtaining Technical Assistance Returning System Components WARNING The cover should be removed only by qualified service personnel There are no internal user serviceable parts WARNING Do not spray pour or spill any liquid on the N 3000 its accessories connectors switches or openings in the chassis WARNING If you are uncertain about the accuracy of any measurement check the patient s vital signs by alternate means then make sure the monitor is TROUBLESHOOTING Error Codes When the N 3000 detects an error condition it displays an error code similar to the illustration below PULSE RATE min Sp02 K RI Sp02 If the number is other than one of those listed below turn the instrument off and back on again If the error code reappears record it press the AUDIBLE ALARM OFF button to silence the alarm if present and notify your service personnel Error codes that begin with a 0 are user correctable The following N 3000 error codes are user correctable 53 Troubleshooting and Maintenance EEE 055 SpO2 alarm limits and other settin

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