OPERATOR’S MANUAL N-395 Pulse Oximeter Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician. To contact Mallinckrodt’s representative: In the United States, call 1.800.635.5267 or 314.654.2000; outside of the United States, call your local Mallinckrodt representative. 2000 Mallinckrodt Inc. All rights reserved.
Mallinckrodt Inc. 675 McDonnell Boulevard P.O. Box 5980 St. Louis, MO 63134 Telephone 314.654.2000 Toll Free 1.800.635.5267 Mallinckrodt Europe BV Hambakenwetering 1 5231 DD’s-Hertogenbosch The Netherlands Tel +31.73.6485200 Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588 Nellcor Puritan Bennett Inc. is a wholly owned subsidiary of Mallinckrodt, Inc. Nellcor and Nellcor Puritan Bennett are trademarks of Mallinckrodt Inc.
CONTENTS Figures Tables Contents ................................................................................... iii Figures ................................................................................vii Tables ................................................................................ viii Safety Information....................................................................... 1 General Safety Information .................................................. 1 Introduction .....................
Contents At Initial Power-Up (Sensor Attached to Monitor) .....................32 At Initial Power-Up (No Sensor Attached to Monitor)................32 After Taking Measurements....................................33 Sensor Disconnected..............................................33 Sensor Off...............................................................33 Automatic Shutdown ...............................................33 Alarms ............................................................................
Contents Default Settings ...................................................... 58 Nurse Call Feature ................................................. 60 Battery Operation ............................................................... 61 Low Battery Indicator .............................................. 61 Disposal Of Device Components ....................................... 62 Performance Considerations ............................................. 62 Impact of Patient Conditions on Monitor Readings..
Contents Measured versus Calculated Saturation .................84 Data Port Protocol .....................................................................87 Overview.............................................................................87 Connecting to the Data Port ...............................................87 Baud Rate...........................................................................89 Setting Data Port Protocol ..................................................
Contents FIGURES Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Figure 8: Figure 9: Figure 10: Figure 11: Figure 12: Figure 13: Figure 14: Figure 15: Figure 16: Figure 17: Figure 18: Figure 19: Figure 20: Figure 21: Figure 22: Figure 23: Figure 24: Figure 25: N-395 Front Panel Display (Pleth View) ...................... 5 N-395 Rear Panel ........................................................ 6 GCX Mounting Plate ..................................................
Contents TABLES Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10: Table 11: Table 12: Table 13: viii Nellcor Sensors ...........................................................24 Limits Menu .................................................................43 Trend Menu .................................................................44 Setup Menu .................................................................45 Trend Scale .......................................
SAFETY INFORMATION General Safety Information GENERAL SAFETY INFORMATION This section contains important safety information related to general use of the N-395 pulse oximeter. Other important safety information appears throughout the manual in sections that relate specifically to the precautionary information. Read all text surrounding all precautionary information.
Safety Information 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 (N-395 data port connector) configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC Standard 601-1-1 and the electromagnetic compatibility system standard IEC Standard 601-1-2.
INTRODUCTION Intended Use General Operating Principles and Conditions The latest version of this manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ ProductManuals.html INTENDED USE The N-395 is a portable pulse oximeter intended for use as a continuous non-invasive monitor of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The intended patient population comprises adult, pediatric, and neonatal patients.
Introduction Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed is translated into a measurement of functional oxygen saturation (SpO2). Note: For an explanation of functional versus fractional saturation, refer to Principles of Operation.
CONTROLS, INDICATORS, AND SYMBOLS Displays, Controls, Indicators, and Connectors N-395 Symbols Description of Controls Description of Displays and Visual Indicators Description of Audible Indicators DISPLAYS, CONTROLS, INDICATORS, AND CONNECTORS Figure 1 and Figure 2 show the front and rear views of the N-395 and identify displays, controls, and connectors.
Controls, Indicators, and Symbols 1. Equipotential (ground) Terminal 2. Data Port Connector 3. Fuse Receptacle 4.
Controls, Indicators, and Symbols DESCRIPTION OF CONTROLS Function Buttons The Power On/Off Button. Used to turn the N-395 monitor on or off. The ALARM SILENCE Button. Used to silence current alarms for the alarm silence duration period. When an alarm has been silenced, pressing the button again reactivates, or “unsilences,” the alarm. It is also used to view and adjust alarm silence duration and alarm volume. The ALARM SILENCE button clears “Sensor Off” and “Sensor Disconnect” messages from the display.
Controls, Indicators, and Symbols DESCRIPTION OF DISPLAYS AND VISUAL INDICATORS The %SpO2 Display. Shows the saturation of hemoglobin oxygen. The displayed value flashes zeros during loss-of-pulse alarms and flashes the SpO2 value when SpO2 is outside of the alarm limits. During Pulse Search, the monitor continues to update the display. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the SpO2 value (100.). The Pulse Amplitude Indicator (blip bar).
Controls, Indicators, and Symbols The Alarm Silence Indicator. Lights continuously when an audible alarm has been silenced. It flashes when the alarm silence duration has been set to OFF. The Motion Indicator. Lights when the monitor detects motion artifact. The Pulse Search Indicator. Lights continuously prior to initial acquisition of a pulse signal, and during prolonged and challenging monitoring conditions. It flashes during a loss-of-pulse signal. The SatSeconds Indicator.
Controls, Indicators, and Symbols 10 Low Priority Alarm A low-pitched, slow-pulsing tone indicating a sensor disconnect, sensor off, low battery, or monitor failure Alarm Silence Reminder Three beeps that sound approximately every 3 minutes when alarms are silenced with the alarm silence duration set to OFF Pulse Beep A single beep sounds for each detected pulse. The pitch changes as monitored SpO2 values increase or decrease.
SETUP Unpacking and Inspection Performance Verification List of Components Monitor Setup Language Selection UNPACKING AND INSPECTION Notify the carrier if the shipping carton is damaged. Unpack the N-395 and components. If anything is missing or damaged, contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative.
Setup Optional Accessories Several mounting configurations, a utility basket, and a carrying case are offered with the N-395. Contact Mallinckrodt’s Technical Services Department or your local Mallinckrodt representative for information about these accessories. 12 • GCX Mounting Plate. See Figure 3, page 13. • GCX Poly-mount (vertical wall mount with 19-inch channel). See Figure 4, page 14. • GCX Poly-mount (horizontal wall mount with rail adapter). See Figure 5, page 15.
Setup GCX Mounting Plate An optional mounting plate is available from Mallinckrodt for the N-395. This mounting plate fits standard, commercially available GCX mount brackets, and is used to securely mount the monitor to a wall or roll stand. The plate attaches to the bottom of the N-395 monitor as shown in Figure 3. For further instructions regarding connecting the plate to GCX brackets, refer to the illustrated directions for use included with the GCX mounting plate.
Setup GCX Poly-mount (vertical wall mount with 19-inch channel) An optional vertical wall mount with 19-inch channel is available from Mallinckrodt for the N-395. The vertical wall mount with 19-inch channel attaches to the N-395 monitor GCX mounting plate as shown in Figure 4. For further instructions regarding connecting the vertical wall mount with 19-inch channel, refer to the illustrated directions for use included with the vertical wall mount with 19-inch channel.
Setup GCX Poly-mount (horizontal wall mount with rail adapter) An optional horizontal wall mount with rail adapter is available from Mallinckrodt for the N-395. The horizontal wall mount with rail adapter attaches to the N-395 monitor GCX mounting plate as shown in Figure 5. For further instructions regarding connecting the horizontal wall mount with rail adapter, refer to the illustrated directions for use included with horizontal wall mount with rail adapter.
Setup GCX Roll Stand Poly-mount An optional GCX roll stand poly-mount is available from Mallinckrodt for the N-395. The GCX roll stand poly-mount attaches to the N-395 monitor GCX mounting plate as shown in Figure 6. For further instructions regarding connecting the GCX roll stand poly-mount, refer to the illustrated directions for use included with GCX roll stand poly-mount.
Setup GCX Utility Basket An optional GCX utility basket is available from Mallinckrodt for the N-395. The GCX utility basket attaches to the GCX roll stand polymount as shown in Figure 7. For further instructions regarding connecting the GCX utility basket, refer to the illustrated directions for use included with GCX utility basket.
Setup Soft-Sided Carrying Case An optional soft-sided carrying case is available from Mallinckrodt for the N-395. See Figure 8. The padded carrying case protects the N-395 while transporting the monitor. The carrying case contains two pockets for sensors, cables, and operator’s manual. Figure 8: Soft Sided Carrying Case MONITOR SETUP General Warnings WARNING: To ensure patient safety, do not place the monitor in any position that might cause it to fall on the patient.
Setup WARNING: Disconnect the N-395 and Nellcor sensor from the patient during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The N-395 may affect the MRI image and the MRI unit may affect the accuracy of oximeter measurements. WARNING: To ensure accurate performance and prevent device failure, do not subject the N-395 to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure.
Setup The battery may discharge during prolonged storage or shipment. If the monitor has been in storage for more than 2 months, it is important to plug the monitor into an AC outlet and allow the battery to charge for approximately 30 minutes before attempting to operate the instrument on AC power. To charge a low battery, connect the monitor to AC power. A full charge of a completely discharged battery takes 14 hours while the monitor is turned off. 1. Place the N-395 on a flat surface near the patient.
Setup WARNING: Do not use a sensor cable with the N-395 monitor (other than the SCP-10 or MC-10 sensor cable). Use of another sensor cable will have an adverse effect on performance. Do not attach any cable that is intended for computer use to the sensor port. Do not connect any device other than a Nellcor approved sensor to the sensor connector. 6.
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SENSORS Selecting a Sensor Biocompatibility Testing Performance Considerations SELECTING A SENSOR WARNING: Before use, carefully read the sensor directions for use, including all warnings, cautions, and instructions. WARNING: Do not use a damaged sensor or sensor cable. Do not use a sensor with exposed optical components. WARNING: Use only Nellcor sensors and sensor cables with this monitor. Other sensors or sensor cables may cause improper N-395 performance.
Sensors Table 1: Nellcor Sensors Sensor Model Patient Size N-25/N-25LF I-20 D-20 D-25/D-25L R-15 <3 or >40 kg 3 to 20 kg 10 to 50 kg >30 kg >50 kg Oxibandâ oxygen transducer (Reusable with disposable nonsterile adhesive) OXI-A/N OXI-P/I <3 or >40 kg Oxi 1-2-3 oxygen sensor (Multiuse, nonsterile) Ox123-A/N <3 or >40 kg Ox123-P/I 3 to 40 kg Durasensorâ oxygen transducer (Reusable, nonsterile) DS-100A >40 kg Nellcor reflectance oxygen transducer (reusable, nonsterile) RS-10 >40 kg Dura-Yâ
Sensors PERFORMANCE CONSIDERATIONS WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions.
Sensors Note: Failure to take this precaution 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.
START-UP AND USE Basic Operation Alarms Adjustable Settings Menu Limits Trend Setup Battery Operation Disposal of Device Components Performance Considerations BASIC OPERATION WARNING: The N-395 is a prescription device and is to be operated by qualified personnel only. WARNING: Do not lift the monitor by the sensor cable or power cord because the cable or cord could disconnect from the monitor, causing the monitor to drop on the patient.
Start-Up and Use WARNING: Each time the monitor is used, check alarm limits to ensure that they are appropriate for the patient being monitored. Important! Prior to using the N-395, carefully read this manual, accessory directions for use, all precautionary information in boldface type, and all specifications. Before using the N-395 in a clinical setting, verify that the monitor is working properly and is safe to use.
Start-Up and Use 3. During the POST, the entire display lights and then the Nellcor brand with model number and software version are displayed for approximately 3 seconds. All indicator lights illuminate briefly. Caution: If any indicator or display element does not light, do not use the monitor. Instead, contact qualified service personnel, your local Mallinckrodt representative, or the Mallinckrodt Technical Services Department. 4.
Start-Up and Use Figure 9: Monitoring Mode Display - Pleth View Figure 10: Monitoring Mode Display – Blip (Magnified) View Adult-Pediatric and Neonatal Settings WARNING: Each time the monitor is used, check alarm limits to ensure that they are appropriate for the patient being monitored. Before monitoring, ensure that the N-395 is in the patient setting (adult-pediatric or neonatal) appropriate for the patient being monitored.
Start-Up and Use Note: The default power-on operating mode can be changed to the neonatal patient setting by qualified service personnel using the configuration mode described in the N-395 service manual. When the patient setting (adult-pediatric or neonatal) is changed, alarm limits return to power-on defaults for the respective settings and previous patient data is cleared from the display. In the neonate mode, there are different default settings used. Refer to Default Settings, page 58.
Start-Up and Use Note: Verify that indicators, display information, and audible sounds including alarms are operational, indicating that the monitor is functioning. Each valid button press should generate an appropriate audible or visual action. Observe movement of the Pulse Amplitude Indicator or pleth waveform, and listen for pulse beeps to verify that measurements are being made. Note: If any action does not seem appropriate, do not use the monitor.
Start-Up and Use After Taking Measurements If a pulse was previously acquired and then lost, the N-395 enters Pulse Search, and the Pulse Search indicator lights. The last detected readings are displayed while the monitor searches for a valid pulse. When the monitor considers the pulse “lost,” it displays zeroes and a high priority alarm sounds. When a valid pulse is detected, the N-395 exits the Pulse Search Mode and displays the current readings. The Pulse Search indicator goes out.
Start-Up and Use ALARMS The following paragraphs describe the three levels of audio alarms and discuss the management of the loss-of-pulse alarm. Description of Alarms The N-395 has three levels of audible alarms. 1. High-priority alarm: Indicated by a fast-rate, high-pitched, pulsing tone. A high-priority alarm sounds after loss-ofpulse is detected. During a high-priority alarm, the display flashes with the patient parameter that violated the limit. 2.
Start-Up and Use SatSeconds Alarm Management With traditional alarm management, upper and lower alarm limits are set for monitoring oxygen saturation. During monitoring, as soon as an alarm limit is violated by as little as one percentage point, an audible alarm immediately sounds. When the %SpO2 level fluctuates near an alarm limit, the alarm sounds each time the limit is violated. Such frequent alarms can be distracting. The N-395 utilizes Nellcor SatSeconds alarm management technique.
Start-Up and Use %SpO2 2x 4x 6x Seconds 2= 3= 6= Total SatSeconds = SatSeconds 4 12 36 52 After approximately 10.9 seconds the SatSeconds alarm would sound, because 50 SatSeconds had been exceeded. See arrow (é) in Figure 5. Figure 11: Alarm Response with SatSeconds Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Often, %SpO2 levels may fluctuate above and below the alarm limit, re-entering the non-alarm range several times.
Start-Up and Use During such fluctuation, the N-395 integrates the number of %SpO2 points, both positive and negative, until either the SatSeconds limit (SatSeconds setting) is reached, or the %SpO2 level returns within a normal range and remains there. SatSeconds "Safety Net" The SatSeconds "Safety Net" is for patients with saturation having frequent excursions below the limit, but not staying below the limit long enough for the SatSeconds setting to be reached.
Start-Up and Use SatSeconds Display When the N-395 SatSeconds technology detects an SpO2 value outside the alarm limit, the SatSeconds indicator begins to “fill” clockwise. When the SpO2 value is within the set limits, the SatSeconds indicator will empty counter-clockwise. As seconds pass and are compared against the alarm-limit and the SatSeconds setting, the graph fills or empties proportionately.
Start-Up and Use Alarm Volume To view the current volume of the audible alarm, press and hold the ALARM SILENCE Button for more than 3 seconds. The current volume level is indicated in the Pulse Rate Display as a value from 1 (lowest) to 10 (highest). A tone at the displayed level sounds. To adjust the volume, press and hold the ALARM SILENCE Button until VOL is displayed. Continue pressing the ALARM SILENCE Button and press the ADJUST UP or ADJUST DOWN Button to change the setting.
Start-Up and Use If the alarm condition is still present when the alarm silence duration has elapsed, the alarm will sound. WARNING: Do not silence an audible alarm or decrease its volume if patient safety could be compromised. Disabling Audible Alarms Setting the alarm silence duration to OFF means that the monitor will produce no audible alarms.
Start-Up and Use MENU Menu Structure The four softkeys on the front panel are used to view or adjust the following N-395 settings or functions: • %SpO2 and pulse rate alarm limits • Pleth or Blip view • Time and date settings • Data port baud rate settings • Trend data viewed (%SpO2, pulse, or both) • “Zoom” factor of trend data • Graph of trend data (histogram) • Delete all trend data • Print trends • SatSeconds limits • Language displayed on screen or data port • Nurse call settin
Start-Up and Use A description of each menu item is included in the following paragraphs. LIMITS WARNING: Each time the monitor is used, check alarm limits to ensure that they are appropriate for the patient being monitored. Overview When the N-395 is first turned on, alarm limits are set to their power-on default values. Qualified service personnel, using the instructions described in the N-395 service manual, may change power-on default alarm limits.
Start-Up and Use Changing Alarm Limits Use the SELECT softkey to select the parameter that is to be changed. Use the ADJUST UP/DOWN Buttons to change the settings. The setting takes effect immediately and remains in effect when the alarm setting menu is exited.
Start-Up and Use Table 3: Trend Menu 44
Start-Up and Use Table 4: Setup Menu 45
Start-Up and Use Alarm Limits Changed Indicator If alarm limits are changed from the N-395’s power-on defaults, a decimal point appears after the displayed value and in the %SpO2 and Pulse Rate Display as illustrated in Figure 12. The decimal point remains on the display until the N-395 is turned off or the limit is returned to its default value. Figure 12: Alarm Limits Selection TREND The N-395 can graphically display trends for SpO2, pulse rate, or both. Trend data is stored at 4-second intervals.
Start-Up and Use Figure 13: SpO2 Trend Periods of time when no measurements were acquired are indicated by blank spaces in the graph as shown in Figure 13. The number of trend hours or minutes currently displayed on the screen is indicated in the upper left corner. The date and time indicate the location of the cursor on the top middle and right of the screen. The cursor is moved right or left by using the ADJUST UP/DOWN Buttons.
Start-Up and Use Scrolling past the limits of the right or left edges of the screen causes the viewing area to shift, relocating the cursor to the middle of the screen if enough trend data is available. For example, suppose the time represented by the right-hand edge of the screen in Figure 13 is 14:54:05. Scrolling one time period to the right (4 minutes) results in the cursor relocating to the center of the screen at the time period 14:58:05, with 6 hours of data on both sides of the cursor.
Start-Up and Use SpO2 Trend Display The SpO2 trend display provides information on the %SpO2 trend. See Figure 15. Figure 15: SpO2 Trend Display Pulse Rate Trend Display The pulse rate trend display provides information on the pulse rate trend. See Figure 16. Figure 16: Pulse Rate Trend Display Histogram The histogram view is illustrated in Figure 17.The histogram graphically illustrates the percentage of time a given range of values has been measured.
Start-Up and Use 12HR HISTOGRAM %SPO2 96-100 91-95 86-90 81-85 0-80 VIEW 68% 7% 0% 0% 25% EXIT 25JUL 04:02--25JUL 16:02 BPM 201-250 0% 151-200 0% 101-150 18% 51-100 57% 0-50 25% NEXT Figure 17: Histogram AMP (Amplitude) Trend Display The AMP trend display provides trend information on the pulse amplitude. See Figure 18. Figure 18: AMP Trend Display Zoom Pressing the ZOOM softkey changes the period of time displayed on a trend graph.
Start-Up and Use back in time as the DOWN ARROW button is pressed and forward in time as the UP ARROW button is pressed. Figure 19: 40-Second Trends When the oldest reading on the screen is highlighted and the DOWN ARROW button is pressed again, the screen shifts to display an older column of readings. Similarly, if the newest reading on the screen is highlighted and the UP ARROW button is pressed, the screen shifts to display a newer column of readings.
Start-Up and Use GRAPH MODE: The graph mode disables all printouts except for trend printouts. Pressing the PRINT softkey from the trend menu will print a graphical printout of the displayed graphical trend data. The amount of data printed is the same as the trend being displayed. Contact Mallinckrodt’s Technical Services Department for a list of compatible printers. Refer to Data Port Protocol of this manual for more information concerning the data port.
Start-Up and Use Note: The N-395 will time out in 5 minutes when the SET and EXIT softkeys are displayed. However, it will time out in 10 seconds after the SET button is pressed if there are no further button presses. Press the EXIT button to accept the new settings. Press EXIT again to return to the previous menu. COMM Press the NEXT softkey to access the COMM softkey. The COMM softkey provides selection of the baud rate and the protocol of the data port.
Start-Up and Use Agilent (HP) Communications The N-395 sends SpO2, pulse rate, and alarm status data to the Agilent monitor. The Agilent monitor requires an Agilent VueLink Aux Plus B interface module to interface with the N-395 pulse oximeter. The RS-232 hardwire interface cable has a DB-15 connector for the N-395 and the applicable connector for the Agilent monitor. Nellcor cable part number 902256 is recommended for this interface.
Start-Up and Use Figure 20: SpaceLabs Connection Caution: The SpaceLabs monitor must be turned on before the N-395 monitor is turned on. The SpaceLabs monitor requires a Universal FlexPort interface module to interface with the N-395 pulse oximeter. The RS-232 hardwire interface cable has a DB-15 connector for the N-395 and the applicable connector for the SpaceLabs FlexPort interface module cable. Nellcor cable part number 036341 is recommended for this interface.
Start-Up and Use WARNING: Do not silence the N-395 audible alarm or decrease its volume if patient safety could be compromised. The SpaceLabs monitor provides both audible and visual alarm indications. Silencing the N-395 alarm will also silence the SpaceLabs monitor alarms. The monitors must be able to sound an audible alarm in order to maintain patient safety. Marquette Communications The N-395 sends SpO2, pulse rate, and alarm status data to the Marquette monitor.
Start-Up and Use Datex-Ohmeda Communications The Datex-Ohmeda monitor AS/3 must be configured for communications with the Nellcor N-200 monitor in order to communicate with the N-395 monitor. Refer to the AS/3 operator’s manual for instructions on configuring the AS/3 monitor. The N-395 sends SpO2, pulse rate, and alarm status data to the Datex AS/3 monitor. The RS-232 hardwire interface cable has a DB-15 connector for the N-395 and the applicable connector for the Datex monitor.
Start-Up and Use Press the NEXT softkey to access the LANG softkey. After pressing the LANG softkey, use the ADJUST UP/DOWN Buttons to select English, French, German, Italian, Spanish, Dutch, or Portuguese. If the language is changed and EXIT is pressed (or a 10-second timeout occurs), the monitor begins displaying data in the selected language. NCALL The NCALL softkey provides the capability of setting the alarm voltage at a normally high (NORM +) or normally low (NORM -).
Start-Up and Use Table 6: Factory Default Settings (Adult) Monitoring Mode Adult %SpO2 Lower Alarm Limit: 85% %SpO2 Upper Alarm Limit: 100% Alarm Silence Duration OFF Setting: Enabled Alarm Silence Duration: 60 seconds Alarm Silence Reminder: Enabled Alarm Volume: 75 dB(A) peak at 1 meter (volume setting of 5) Data Port Baud Rate: 9600 Data Port Protocol: ASCII Display Contrast: Midrange Display Format: Pleth Language: English Nurse Call Polarity: Normally Low Pulse Beep Volume:
Start-Up and Use Table 7: Factory Default Settings (Neonate) Monitoring Mode Neonate Note: There are different default settings for the neonate mode. %SpO2 Lower Alarm Limit: 80% %SpO2 Upper Alarm Limit: 95% Pulse Rate Lower Alarm Limit: 90 beats per minute Pulse Rate Upper Alarm Limit: 190 beats per minute SatSeconds: Off Nurse Call Feature WARNING: The nurse call feature should not be used as the primary source of alarm notification.
Start-Up and Use BATTERY OPERATION The N-395 has an internal battery that may be used to power the monitor during transport or when AC power is not available. A new, fully charged battery will provide at least 2 hours of monitoring time under the following conditions: no audible alarms sound, and no analog or serial output devices are attached. Note: Whenever the monitor is connected to AC power, the battery is being charged.
Start-Up and Use Note: If the AC voltage selector switch on the rear panel does not match the AC voltage source, the monitor may run on battery power, even though it is plugged in, which will eventually result in a low priority alarm and a lighted low battery indicator. Ensure that the switch setting matches the AC voltage. If the monitor is not connected to AC power within approximately 15 minutes, it will shut down.
Start-Up and Use Inaccurate measurements can be caused by: • prolonged patient movement • venous pulsations • intravascular dyes, such as indocyanine green or methylene blue • significant levels of dysfunctional hemoglobins • defibrillation Ambient environmental conditions and sensor application errors, which can affect pulse oximetry readings, are discussed in the Sensors and Accessories section of this manual and in the sensor directions for use.
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TROUBLESHOOTING AND MAINTENANCE Troubleshooting EMI (Electromagnetic Interference) Obtaining Technical Assistance Returning the N-395 Maintenance TROUBLESHOOTING 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 functioning correctly. WARNING: The cover should be removed only by qualified service personnel. There are no user-serviceable parts inside.
Troubleshooting and Maintenance Table 8: Error Codes and Messages Error Code 4 Error Message LOW BATTERY Action The battery is discharged to a critically low level. Check to ensure that the voltage selector switch on the rear panel is set to the proper voltage. Turn the monitor off and let it charge for approximately 10 minutes and then reattempt to turn the unit on. If the error code is still present, turn the unit off and let it continue to charge.
Troubleshooting and Maintenance SENSOR OFF - The sensor has become disconnected from the patient. Press the ALARM SILENCE Button to silence the alarm. Check the sensor to patient connection. If this does not correct the problem, replace the sensor. DISALLOWED ON BATTERY - An attempt to print or download data port information while operating on battery power has been made. Connect to AC power and retry.
Troubleshooting and Maintenance • If operating on battery power, the battery may be missing or discharged. If the battery is discharged, notify service personnel to charge or replace the battery. 2. One or more display elements or indicators do not light during the power-on self-test. • Do not use the N-395; contact qualified service personnel or your local Mallinckrodt representative. 3. The monitor is operating on battery power, even though it is connected to AC.
Troubleshooting and Maintenance • The sensor may be too tight, there may be excessive ambient light, or the sensor may be on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. Reposition sensor, as necessary. • Excessive environmental motion or electromagnetic interference may be preventing the N-395 from tracking the pulse. Remove the source of interference or try to stabilize the environment, or do both. 5.
Troubleshooting and Maintenance EMI (ELECTROMAGNETIC INTERFERENCE) Caution: This device has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1993, EN 60601-1-2:1994, Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
Troubleshooting and Maintenance OBTAINING TECHNICAL ASSISTANCE The latest version of this manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ ProductManuals.html For technical information and assistance, or to order parts or a service manual, contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative. The service manual includes block diagrams and a parts list required by qualified personnel when servicing the N-395.
Troubleshooting and Maintenance The N-395 requires no routine service or calibration other than changing the battery at least every 24 months. If service is necessary, contact qualified service personnel or your local Mallinckrodt representative. Periodic Safety Checks It is recommended that the following checks be performed every 24 months. • Inspect the equipment for mechanical and functional damage. • Inspect the safety relevant labels for legibility.
SPECIFICATIONS Performance Electrical Environmental Conditions Physical Characteristics Compliance PERFORMANCE Measurement Range SpO2 Pulse Rate 1 - 100% 20 - 250 beats per minute (bpm) Accuracy1 Saturation (%SpO2 ±1 SD) Without Motion: Adults Neonates 70 - 100% ±2 digits 70 - 100% ±3 digits 1 - 69% unspecified With Motion:2 Adults and Neonates 70 - 100% ±3 digits 1 - 69% unspecified 1 Accuracies are expressed as plus or minus “X” digits (oxygen saturation percentage points) between saturation of 7
Specifications Pulse Rate1 Without Motion With Motion 20 - 250 ±3 digits Normal physiologic range (e.g., 55 – 125 bpm) ±5 digits ELECTRICAL Instrument Power Requirements Fuses 100 - 120 VAC, 200 - 240 VAC, 50/60 Hz, 20 VA switch selectable 2 qty, 0.5 A, 250 volts, slow-blow, IEC (5 x 20 mm) Battery Type Lead-Acid Battery Capacity A minimum of 2 hours with a new, fully charged battery under the following conditions: no alarms, and no analog or serial output devices attached.
Specifications ENVIRONMENTAL CONDITIONS Transport and Storage (in shipping container) Temperature Altitude/Barometric Pressure -20 to 70°C (-4°F to +158°F) -390 m to 4,572 m (-1280 ft. to 15,000 ft.) 106 kPa to 50 kPa (31.3 in. Hg to +14 in. Hg) 15 – 95% noncondensing Relative Humidity Transport and Storage (not in shipping container) Temperature Altitude/Barometric Pressure -20°C to +60°C (-4°F to +140°F) -390 m to 4,572 m (-1280 ft. to 15,000 ft.) 106 kPa to 50 kPa (31.3 in. Hg to +14 in.
Specifications COMPLIANCE Emissions Compliance Equipment Classification Type of Protection Degree of Protection Enclosure Degree of Ingress Protection from Solids/Liquids Mode of Operation EMI Compatibility 76 EN55011, CISPR 11, Group 1, Class B IEC 60601-1 / CSA 601.
QUICK GUIDE TO OPERATION Introduction Settings Adjustments INTRODUCTION This Quick Guide to Operation is intended for use by experienced N-395 users. First-time users of the monitor should read the entire Operator’s Manual before use. To turn the monitor on or off press SETTINGS ADJUSTMENTS Table 9 contains the procedures necessary to adjust or view the basic N-395 settings. In general, press EXIT to return to the main menu.
Quick Guide to Operation Table 9: Settings Adjustments To Adjust Alarm Silence Duration Action Press and hold (for less than 3 seconds) then, Press Alarm Volume or Press and hold (for more than 3 seconds) while continuing to hold, Press Baud Rate Button or Press Press Press Press To select the desired baud rate Press 78 or
Quick Guide to Operation Table 9: Settings Adjustments To Adjust Bedside Monitor Interface Action Button Press Press Press Press Press To select AGILENT, SPACELBS, MARQ, or DATEX or Press Contrast Press and hold Press or 79
Quick Guide to Operation Table 9: Settings Adjustments To Adjust Language Action Button Press Press Press Press Press Pleth or Blip (magnified) View or , Press Press Select or Press Pulse Beep Volume 80 Press and hold or
Quick Guide to Operation Table 9: Settings Adjustments To Adjust SatSeconds Action Button Press Press to select SatSeconds Press or Press 81
Quick Guide to Operation Table 9: Settings Adjustments To Adjust Time and Date Settings Action Button Press Press Press Press (to select setting) Press Press (to return to main menu) Trends Press Press Select desired view 82 or , ,
PRINCIPLES OF OPERATION Oximetry Overview OXIMETRY OVERVIEW Pulse oximetry is 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 (i.e., plethysmography).
Principles of Operation During monitoring, the instrument’s software reads this resistor value and selects coefficients that are appropriate for the wavelength of that individual sensor’s red LED; these coefficients are then used to determine SpO2. This resistor value 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 light intensity of the sensor’s LEDs is adjusted automatically.
Principles of Operation Figure 21: Oxyhemoglobin Dissociation Curve 85
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DATA PORT PROTOCOL Overview Connecting to the Data Port Baud Rate Setting Data Port Protocol Real-Time Display Format Trend Data Printout (ASCII Mode) Trend Data Printout (Graph Mode) Nurse Call Analog Outputs OVERVIEW Patient data can be obtained through the data port on the back of the N-395 by connecting it to an attached PC or serial printer. When connecting the N-395 to a printer or PC, verify proper operation before clinical use.
Data Port Protocol (Information Technology Equipment) device must be certified to UL-1950 or IEC-60950. The cable used must have a braided shield providing 100% coverage, such as a Belden cable (Belden part number 9609) or equivalent. The shield must have a 360-degree connection to the metal shell on the N-395’s DB-15 connector and to the connector on the PC or serial printer. Do not create sharp bends in the cable, as this may tear or break the shielding.
Data Port Protocol The pin layouts (as viewed from the rear panel of the N-395) are illustrated in Figure 22. The conductive shell is connected to earth ground when connected to a PC or printer. Figure 22: Data Port Pin Layout Pins 2, 3, and 5 provide data in RS-232 format. Pins 1, 4, 9, and 12 provide data in RS-422 format. TxD+ and TxD- are the differential transmit data pair. RxD+ and RxD- are the differential receive pair. No hardware flow control is used.
Data Port Protocol Note: Selections for Agilent, SpaceLabs, GE Marquette, and Datex are included in N-395 software versions 1.7 and higher. The protocol settings allow the N-395 to communicate with various devices. ASCII is used during normal operation and for serial printers. GRAPH is used for graphical trend printouts when connected to a serial printer that supports Epson ESC protocol. Select OXINET when connecting to an Oxinetâ II central station network or Score software.
Data Port Protocol N-395 VERSION 2.0.0.
Data Port Protocol Data Source N-395 TIME VERSION 2.0.0.0 CRC: XXXX %SpO2 BPM SpO2 Limit: 70-100% PA Status PR Limit: 60-160BPM Data in the highlighted box above represents the model number of the monitor, in this case the N-395. Software Revision Level N-395 TIME VERSION 2.0.0.0 CRC: XXXX %SpO2 BPM SpO2 Limit: 70-100% PA Status PR Limit: 60-160BPM The next data field tells the user the software level, (Version 2.0.0.0) and a software verification number (CRC: XXXX).
Data Port Protocol Patient Data and Operating Status Time TIME 12-NOV-99 14:00:05 %SpO2 100 BPM 120 PA 50 Status The Time column represents the N-395 real-time clock. Patient Data N-395 VERSION 2.0.0.0 CRC: XXXX TIME %SpO2 BPM 12-NOV-99 14:00:05 100 120 SpO2 Limit: 70-100% PA Status 50 PR Limit: 60-160BPM Patient data is highlighted in the display above. Parameter values are displayed directly beneath the heading for each parameter.
Data Port Protocol Table 11: Status Codes Code Meaning AO Alarm Off AS Alarm Silence LB Low Battery LM Loss of Pulse w/ Motion LP Loss of Pulse MO Patient MOtion PH Pulse Rate High Limit Alarm PL Pulse Rate Low Limit Alarm PS Pulse Search SH Sat High Limit Alarm SL Sat Low Limit Alarm SD Sensor Disconnect Note: A sensor disconnect will also cause three dashes (- - -) to be displayed in the patient data section of the display or printout.
Data Port Protocol N-395 VERSION 2.0.0.0 TREND TIME %SpO2 BPM 12-NOV-99 14:00:05 100 120 12-NOV-99 14:00:07 100 121 12-NOV-99 14:00:09 100 120 Output Complete SpO2 Limit: 70-100% PA Status 150 154 150 PR Limit: 60-160BPM Figure 24: Trend Data Printout (ASCII MODE) Once a trend printout has begun, it cannot be aborted without turning off the N-395 or the printer. TREND DATA PRINTOUT (GRAPH MODE) The graph mode (Figure 25) disables all printout functions except trend data.
Data Port Protocol alarm determine the voltage between these pins. The nurse call polarity is set by using the procedures in the Start-up and Use section. To access the nurse call menu from the main menu, press softkeys SETUP, NEXT, NEXT and NCALL. When the nurse call polarity setting is normally high (NORM +) and there is no alarm condition, the voltage between pins 11 and 10 will be +5 to +12 volts DC.
Data Port Protocol ANALOG OUTPUTS The N-395 data port also provides analog voltage outputs between pins 6, 13, 14, and ground (pins 5 or 10), which can be used to calibrate instruments such as a chart recorder. The voltage represents a specific measured parameter’s current value. The voltage differential varies proportionally from 0 to 1 volt as the pin’s parameter varies over its full range of values, as indicated in Table 13.
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INDEX 4 40-Second Trend Table · 50 A Accessories · 12 Adjustable Settings · 38 Agilent (HP) Communications · 54 Alarm Limits Changing · 43 Viewing Current · 42 Alarm Limits Changed Indicator · 46 Alarm Management SatSeconds · 35 Alarm Silence Duration · 39 Alarm Silence Reminder · 40 Alarm Volume · 39 Alarms Description · 34 High-Priority · 34 Low-Priority · 34 Medium-Priority · 34 ANALOG · 58 Analog Output · 97 ASCII Mode · 94 ASCII MODE · 51 Automatic Shutdown · 33 B Basic Operation · 28 Battery Operati
Index F L Front Panel · 5 LANG · 57 Language Selection · 21 LIGHT · 58 Limits · 42 Limits Menu · 43 Loss-of-pulse · 25 Low Battery Indicator · 61 Low Peripheral Perfusion · 26 G GCX Mounting Plate · 13 GCX Poly-mount · 14, 15 GCX Roll Stand Poly-mount · 16 GCX Utility Basket · 17 GRAPH MODE · 52 H Histogram · 49 I Inaccurate measurements · 25, 63 Indicators AC Power · 8 Alarm Limits Changed · 46 Alarm Silence · 9 Alarm Silence Reminder · 10 Confirmation Tone · 10 High Priority Alarm · 9 Invalid Butto
Index P Packing List · 11 Patient Cosiderations Impact of Readings · 62 Patient Movement · 26 Performance Considerations · 25, 62 Performance Verification · 11, 72 Periodic Maintenance · 72 Poor Perfusion · 26 Power-On Self-Test (POST) · 28 Principles of Operation · 83 PRINT · 51 Printout Alarm Limits · 92 ASCII Mode · 94 Column Headings · 91 Data Source · 92 GRAPH Mode · 95 Operating Status · 93 Patient Data · 93 Software Revision Level · 92 Pulse Beep Volume · 38 Pulse Search · 32 Q Quick Guide to Opera
Index Pulse Rate · 74 SpO2 · 73 Start Up and Use · 27 Status Codes · 94 Symbols Date of Manufaqcture · 6 Equipotential (Ground) Terminal · 6 Fuse Replacement · 6 See Instructions · 6 Type BF Equipment · 6 Symbopls Data Interface · 6 T Taking Measurements · 33 Technical Assistance · 71 Trend · 46 Histogram · 49 View · 48 ZOOM · 50 Trend Data Printout (ASCII Mode) · 94 Trend Data Printout (GRAPH Mode) · 95 Trend Menu · 44 102 Trend Scale · 47 Trends 40-Second Trend Table · 50 Troubleshooting · 65 U Unpack
