Operator’s Manual Nellcor™ OxiMax N-560 Pulse Oximeter
COVIDIEN, COVIDIEN with logo, the Covidien logo and "positive results for life" are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2011 Covidien. U.S. Patents 5,485,847; 5,676,141; 5,743,263; 6,035,223; 6,226,539; 6,411,833; 6,463,310; 6,591,123; 6,708,049; 7,016,715; 7,039,538; 7,120,479; 7,120,480; 7,142,142; 7,162,288; 7,190,985; 7,194,293; 7,209,774; 7,212,847; 7,400,919.
Contents Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Warnings ...............................
Contents No Sensor Attached ......................................................................................... 26 Sensor Message .................................................................................................... 26 Setting the Pulse Beep Volume .............................................................................. 27 Setting the Alarm Volume ..................................................................................... 28 Setting Alarm Silence Duration ..............
Contents Using the Data Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Overview ...............................................................................................................47 Connecting to the Data Port ..................................................................................47 Data Port Pinouts ...................................................................................................48 Data Port Setup .......................
Contents Sensor Performance Considerations ...................................................................... 70 Operator’s Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Error Codes ........................................................................................................... 75 Corrective Action .................................
Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Front Panel Buttons and Symbols ............................................................ 5 Rear Panel Symbols ................................................................................. 6 Data Port Pin Layout .............................................................................. 49 Real-Time Data Printout ........................................................................ 56 Trend Data Printout ............
Tables Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10: vi Data Port Pinouts .....................................................................................48 Nellcor Oximetry Sensor Models and Patient Weights ...............................64 Operator’s Menu .....................................................................................73 Error Codes ..............................................................................................
Safety Information Warnings Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user. WARNING: Explosion hazard. Do not use the N-560™ pulse oximeter in the presence of flammable anesthetics or gases. WARNING: Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions.
Safety Information CAUTION: When connecting the N-560 to any instrument, verify proper operation before clinical use. Both the N-560 and the instrument connected to it must be connected to a grounded outlet. Accessory equipment connected to the N-560's data interface must be certified according to IEC Standard 60950 for data-processing equipment or IEC Standard 60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements.
Introduction Introduction WARNING: The N-560 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. Do not make any clinical judgments based on the oximeter's measurements only. Intended Use for the N-560 The N-560 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
Introduction How to Use this Manual All users should read this manual thoroughly. More experienced users of the N-560 can directly go to topics for the information they require. This manual is available on the internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ ProductManuals.
Description of Controls, Indicators, and Symbols Description of Controls, Indicators, and Symbols Identification of Front Panel Buttons and Symbols Figure 1: Front Panel Buttons and Symbols 1. SpO2 Sensor Port 12. SatSeconds Alarm Limit Button 2. Power On/Off Button 13. SpO2 Alarm Limit Button 3. %SpO2 Display 14. Interference Indicator 4. Pulse Amplitude Indicator 15. Sensor Off Indicator 5. Pulse Rate Display 16. Sensor Message Indicator 6. Alarm Silence Button 17. Pulse Search Indicator 7.
Description of Controls, Indicators, and Symbols Identification of Rear Panel Components 1. Data Port Connector 3. AC Power Connector 2. Visual Alarm Connector 4. Equipotential Connector (ground) Figure 2: Rear Panel Symbols N-560 Symbols The symbols that are located on the rear panel of the N-560 are as follows: 1. Data Interface 2. Caution - Do not connect while power is on 6 3.
Description of Controls, Indicators, and Symbols The symbols that are located on the front panel of the N-560 are as follows: 1. Type BF Applied Part - Not Defibrillator Proof 6. Pulse Search 2. Pulse Rate 7. Data In Sensor 3. Interference 8. Low Battery 4. Sensor Off 9. AC Power/Battery Charge 5. Sensor Message Description of Controls Note: Each button press, except the Power On/Off button, should result in either a valid or an invalid button tone.
Description of Controls, Indicators, and Symbols The Alarm Silence button is used to silence current alarms for the alarm silence duration period. When an alarm has been silenced, pressing the button again reactivates, or “unsilences” the alarm. It is also used to view and adjust alarm silence duration and alarm volume. The Adjust Up button is used to increase alarm limit values, alarm silence duration, pulse beep volume, alarm volume, and data port baud rate.
Description of Controls, Indicators, and Symbols Description of Displays and Indicators The Pulse Amplitude Indicator (blip bar). A 10-segment LED that indicates pulse beat and shows the relative (non-normalized) pulse amplitude. As the detected pulse becomes stronger, more bars light with each pulse. The %SpO2 Display. Shows the saturation level of oxygenated hemoglobin.
Description of 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 Interference Indicator. Lights whenever the OXIMAX software detects that the incoming signal quality is degraded due to interference (see Interference Explained on page 11).
Description of Controls, Indicators, and Symbols • Secure with headband (MAX-FAST) • Remove nail polish • Loosen sensor (too tight) • Isolate external interference (electrosurgical device, cell phone) • Clean site (MAX-R) The Data In Sensor Indicator. The indicator blinks for approximately one minute when initially connected to the N-560 to indicate that the attached OXIMAX sensor contains a patient sensor event record.
Description of Controls, Indicators, and Symbols Factors which may result in interference include but are not limited to: • incorrect sensor application – sensor placement on an extremity with a blood pressure cuff, arterial catheter, or intravascular line – sensor applied too tightly – incorrect sensor for placement site • intravascular dyes, such as indocyanine green or methylene blue • externally applied coloring agents, such as nail polish, dye, or pigmented cream • failure to cover the sensor with opa
Description of Controls, Indicators, and Symbols Description of Audible Indicators Following are descriptions of N-560 audible indicators.
Description of Controls, Indicators, and Symbols 14
Setting up the N-560 Setting up the N-560 WARNING: Explosion hazard. Do not use the N-560 pulse oximeter in the presence of flammable anesthetics or gases. WARNING: Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. See the appropriate sections of the manual for specific safety information.
Setting up the N-560 WARNING: Do not use an N-560, sensor, cables, or connectors that appear to be damaged. WARNING: The N-560 is not defibrillator-proof. However, it may remain attached to the patient during defibrillation or while an electrosurgical unit is in use, but the readings may be inaccurate during use and shortly thereafter. WARNING: In the USA, do not connect the N-560 to an electrical outlet controlled by a wall switch because the N-560 may be accidentally turned off.
Setting up the N-560 Connecting the N-560 to AC Power 1. Power Connector 1. Plug the female connector of the power cord into the N-560 AC power connector (1). 2. Plug the male connector of the power cord into a properly grounded AC outlet. 3. Verify that the AC Power Indicator is lit. Connecting a Sensor to the N-560 WARNING: Use only the DOC-10 pulse oximetry cable with the N-560. Use of another sensor cable will have an adverse effect on performance.
Setting up the N-560 . 1. SpO2 Sensor Port 1. Connect a DOC-10 pulse oximetry cable to the SpO2 Sensor Port (1) on the front of the N-560. 2. Connect an SpO2 Sensor to the other end of the DOC-10 pulse oximetry cable. Plug the sensor connector firmly into the DOC-10 pulse oximetry cable.
Battery Operation Battery Operation WARNING: Dispose of an old battery by following local guidelines for disposal of nickel metal hydride batteries. Operating the N-560 on Battery Power The N-560 has an internal battery that may be used to power the N-560 during transport or when AC power is not available. A new, fully charged battery will provide at least 8 hours of monitoring time under the following conditions: no audible alarms sound and no serial output devices are attached.
Battery Operation Low Battery Indicator The Low Battery Indicator lights and a low priority alarm begins to sound when 15 minutes but not more than 20 minutes of monitoring time remain on the existing battery charge. This alarm cannot be silenced while running on battery power. Connecting the N-560 to AC power will silence the alarm. If the N-560 is not connected to AC power within approximately 15 minutes, the N-560 will shut off.
Using the N-560 Using the N-560 Turning on the N-560 Discussion Before using the N-560 in a clinical setting, you must verify that the N-560 is working properly and is safe to use. Proper working condition can be verified by successful completion of the Power-On Self-Test (POST), described in the following section. WARNING: The N-560 should not be used adjacent to or stacked with other equipment.
Using the N-560 Procedure 1. Turn on the N-560 by pressing and holding the Power On/Off button for more than one second. 2. The N-560 displays/sounds: Display Sound 5 (in pulse rate left window) one beep tone 6 (in pulse rate center window) one beep tone 0 (in pulse rate right window) one beep tone n (in SpO2 left window) none n (in SpO2 center window) none 3. The N-560 automatically starts the Power-On Self-Test (POST), which tests N-560 circuitry and functions.
Using the N-560 • All indicators illuminate • All segments of all numeric digits light and change from red to green • All segments of the Pulse Amplitude Display light • All segments of the SatSeconds indicator light 5. Once the display test portion of POST is complete, the N-560 software version is displayed for approximately 2 seconds. Note: The device version illustrated is only a sample. The device version identifies the hardware configuration and the software revision.
Using the N-560 6. If the N-560 detects an internal problem during the self-test, an alarm tone sounds and the N-560 displays an Error Code and the corresponding number. See Troubleshooting on page 75. 7. Upon successful completion of the POST, the N-560 sounds a one-second tone indicating that the N-560 has passed the test. WARNING: If you do not hear the POST pass tone, do not use the N-560. WARNING: Ensure that the speaker is clear of any obstruction.
Using the N-560 Sensor Attached The Pulse Search indicator and the Sensor Off indicator light and the N-560 displays dashes in the %SpO2 and Pulse Rate displays while the N-560 is searching for a valid pulse. 1. Sensor Off Indicator 2. Pulse Search Indicator When a valid pulse is detected, the N-560 enters the Monitoring Mode and displays patient parameters.
Using the N-560 When a sensor is connected to the N-560 and is not connected to a patient, the display reads dashes and the N-560 remains in the Pulse Search mode. No Sensor Attached When the sensor is not attached the N-560 displays dashes (---) and the Pulse Search indicator is not lit, indicating that the N-560 failed to detect a sensor. Sensor Message The Sensor Message feature is an indication that the sensor position or site needs to be considered.
Using the N-560 • Use forehead, nasal, or ear sensor (adult patients only) • Use OXIMAX adhesive sensor • Secure cable • Secure with headband (MAX-FAST) • Remove nail polish • Loosen sensor (too tight) • Isolate external interference (electrosurgical device, cell phone) • Clean site (MAX-R) Setting the Pulse Beep Volume 1. SpO2 Sensor Port WARNING: Use only Nellcor-approved sensors and sensor cables. 1.
Using the N-560 3. Place the SpO2 Sensor on the patient or yourself. 4. Turn on the N-560. 5. Press and hold the Adjust Up or Adjust Down button to increase or decrease the pulse beep tone volume. Setting the Alarm Volume With the N-560 in the normal monitoring mode: 1. Press and hold the Alarm Silence button until the alarm volume display appears. 2. While continuing to press the Alarm Silence button, press the Adjust Up button or Adjust Down button to increase or decrease the alarm volume.
Using the N-560 Setting Alarm Silence Duration Discussion WARNING: Do not silence an audible alarm or decrease its volume if patient safety could be compromised. Alarms can be silenced for a preset period called alarm silence duration. To view the current setting, press and hold the Alarm Silence button until 30 SEC, 60 SEC, 120 SEC, or OFF is displayed. To adjust the settings, press and hold the Alarm Silence button until 30 SEC, 60 SEC, 120 SEC, or OFF is displayed.
Using the N-560 Procedure With the N-560 in the normal monitoring mode: 1. Press the Alarm Silence button until XX SEC is displayed. Durations are: OFF, 30, 60, 90, and 120 seconds. Note: For steps 2 and 3, the Adjust Up and Adjust Down buttons must be pressed while pressing the Alarm Silence button. 2. While pressing the Alarm Silence button, press and hold the Adjust Up button to increase alarm silence duration to Off, 30, 60, 90, or 120 seconds. 3.
Using the N-560 Disabling Audible Alarms Discussion Setting the alarm silence duration to OFF means that the N-560 will produce no audible alarms. Visual indications of an alarm condition are not affected by disabling the audible alarms. The ability to set the alarm silence duration to OFF can be enabled or disabled by qualified service personnel as described in the service manual. WARNING: Do not silence the audible alarm or decrease its volume if patient safety could be compromised.
Using the N-560 2. While pressing the Alarm Silence button, press and hold the Adjust Up button until OFF is displayed. Release buttons. 3. The Alarm Silence indicator will flash, indicating that the alarm sounds are disabled. The N-560 will sound three beeps approximately every three minutes to warn the user that the alarm sound has been silenced. Verify Patient Settings With the N-560 in the normal monitoring mode: 1. Press the SpO2 Alarm Limit button to view the current %SpO2 upper alarm limit.
Using the N-560 2. Press the SpO2 Alarm Limit button twice to view the current %SpO2 lower alarm limit. 3. Press the Pulse Rate Alarm Limit button to view the current Pulse Rate upper alarm limit. 4. Press the Pulse Rate Alarm Limit button twice to view the current Pulse Rate lower alarm limit. 5. Press the SatSeconds Alarm Limit button to view the current SatSeconds setting.
Using the N-560 Note: The SatSeconds (12 O’clock) indicator lights, indicating that SatSeconds units are being reviewed. The SatSeconds (12 O’clock) indicator lights for all SatSeconds except Off. Alarm Limits Changed Indicator If an alarm limit is changed from the N-560’s power-on default setting, a decimal point appears after the applicable displayed value, during patient monitoring and when alarm limits are viewed.
Using the N-560 Setting Alarm Limits Discussion Alarm limits determine the upper and lower points of patient data at which the N-560 will sound an alarm. Procedure With the N-560 in the normal monitoring mode: 1. Press SpO2 Alarm Limit button to view the current %SpO2 upper alarm limit. 2. Press the Adjust Up button or Adjust Down button to increase or decrease the alarm limit setting. Note:When an alarm limit is changed from power-on default, the N-560 displays a decimal point (.
Using the N-560 3. Press the SpO2 Alarm Limit button twice to view the current %SpO2 lower alarm limit. 4. Press the Adjust Up button or Adjust Down button to increase or decrease the alarm limit setting. 5. Press the Pulse Rate Alarm Limit button to view the current upper alarm limit for Pulse Rate. 6. Press the Adjust Up button or Adjust Down button to increase or decrease the alarm limit setting. 7. Press the Pulse Rate Alarm Limit button twice to view the current lower alarm limit for Pulse Rate.
Using the N-560 8. Press Adjust Up button or Adjust Down button to increase or decrease the alarm limit setting. Setting SatSeconds Duration Discussion Refer to Describing SatSeconds on page 87 for a description of the SatSeconds function. Procedure With the N-560 in the normal monitoring mode: 1. Press the SatSeconds Alarm Limit button. The current SatSeconds setting is displayed.
Using the N-560 Note:The possible settings for SatSeconds are Off, 10, 25, 50, and 100 seconds. 2. Press the Adjust Up button or Adjust Down button to select the desired SatSeconds setting. Setting the Data Port Baud Rate Discussion The baud rate determines the speed at which the N-560 sends data to the attached equipment (printer or computer). The baud rate is determined by the capabilities of the attached equipment. Procedure With the N-560 in the normal monitoring mode: 1.
Using the N-560 2. Press the Adjust Up button until menu item option 4 is displayed. 3. Press the SatSeconds Alarm Limit button. Current baud rate is displayed. Press the Adjust Up button or Adjust Down button to select the desired baud rate. Possible settings are: N-560 Operator’s Manual • 24 (2,400 bps) • 96 (9,600 bps) • 192 default (19,200 bps).
Using the N-560 Setting the Data Port Protocol With the N-560 in the normal monitoring mode: 1. Simultaneously, press the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for three seconds. Menu option 1 will be displayed. 2. Press the Adjust Up button until menu item option 5 is displayed. 3. Press the SatSeconds Alarm Limit button. Current protocol is displayed.
Using the N-560 4. Press the Adjust Up button or Adjust Down button to select the desired protocol. Possible settings are: 1 - ASCII 2 - External equipment communications. Refer to the external equipment manuals for the interfacing instructions. Clearing Trend Information With the N-560 in the normal monitoring mode: 1. Simultaneously press and hold the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for at least three seconds. Option 1 will be displayed. 2.
Using the N-560 3. Press the SatSeconds Alarm Limit button to clear the trend data. 4. The N-560 emits 3 beeps, indicating that data is cleared.
N-560 Trend N-560 Trend Trend Data Operation From the initial measurement of a patient, trend data (a data point) is stored in memory every 4 seconds. Up to 50 alarm limit changes can also be stored in trend data. The N-560 can store up to 24 hours of trend data. The N-560 trend data will be lost if the coin cell battery fails or is removed. The coin cell battery is located on the main circuit board. CAUTION: Changing alarm limit settings uses trend memory space. Change alarm limits only as needed.
N-560 Trend Trend Data Trend data information may be retrieved or cleared through the N-560 data port using options available in a display menu. To access the menu options, simultaneously press the SpO2 Alarm Limit and Pulse Rate Alarm Limit buttons until Option 1 appears on the display. Then, using the Adjust Up button and Adjust Down button, you may scroll through the available menu options as follows: #1: Trend Print Allows printing of the existing trend data.
N-560 Trend #4: Baud Rate Allows the interconnection to various printers. Refer to Setting the Data Port Baud Rate on page 38. The baud rate selections are: • 24 (2,400 baud rate) • 96 (9,600 baud rate) • 192 default (19,200 baud rate) #5: Data Port Printout Selections are as follows: Option 1 Printout in ASCII characters. Option 2 External equipment communications. Refer to the external equipment manual for the interfacing instructions.
N-560 Trend 46
Using the Data Port Using the Data Port Overview Patient data can be obtained through the data port on the back of the N-560 by connecting it to an attached PC or serial printer. When connecting the N-560 to a printer or PC, verify proper operation before clinical use. Both the N-560 and the printer or PC must be connected to a grounded AC outlet. The N-560 protocol setting must be ASCII. Any printer or PC connected to the N-560's data port must be certified according to IEC Standard 60950.
Using the Data Port No hardware flow control is used. However, in the ASCII mode, XON/ XOFF flow control is supported. Data Port Pinouts TXD represents the Transmit Data line, and RXD is the Receive Data line. The pinouts for the data port are listed in Table 1.
Using the Data Port Figure 3: Data Port Pin Layout Pins 2, 3, 5, and 11 provide data in RS-232 format. Pins 1, 4, 9, and 12 provide data in RS-422 format. TXD+ and TXDare the differential transmit data pair. RXD+ and RXD- are the differential receive pair. Data Port Setup Discussion Use the Data Port Setup procedure to configure the N-560 data port baud rate and protocol. Procedure With the N-560 in the normal operating mode: 1.
Using the Data Port 2. Press the Adjust Up button until Option 4 is displayed. 3. Press the SatSeconds Alarm Limit Button to select Option 4. The selected baud rate will be displayed. Note: The available selections are: • 24 = 2400 baud rate • 96 = 9600 baud rate • 192 = 19200 baud rate 4. Press the Adjust Up button or the Adjust Down button to select the desired baud rate.
Using the Data Port 5. Press the SatSeconds Alarm Limit button to save the desired baud rate. 6. Simultaneously press and hold the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for at least 3 seconds. Option 1 will be displayed. 7. Press the Adjust Up button until Option 5 is displayed.
Using the Data Port 8. Press the SatSeconds Alarm Limit Button to select Option 5. The selected protocol will be displayed. Note: The available selections are: • 1 = Real time ASCII • 2 = External equipment communications. Refer to the external equipment manuals for the interfacing instructions. 9. Press the Adjust Up button or the Adjust Down button to display the desired protocol. 10. Press the SatSeconds Alarm Limit button to save the desired protocol.
Using the Data Port Nurse Call Interface WARNING: The nurse call feature should not be used as the primary source of alarm notification. The audible and visual alarms of the pulse oximeter, used in conjunction with clinical signs and symptoms, are the primary sources for notifying medical personnel that an alarm condition exists. WARNING: The nurse call feature is not functional whenever the pulse oximeter alarms are silenced.
Using the Data Port Pin 11 on the data port is the RS-232 level nurse call signal and pin 5 or 10 is ground (see Table 1 on page 48). When there is no alarm condition, the voltage between pins 10 and 11 is -5 to -12 VDC. Whenever the N-560 is in an alarm condition, the output between pins 10 and 11 is +5 to +12 VDC. This is the default condition (normally low). There is a service menu to change the default condition. Refer to the N-560 service manual for the procedure.
Printing Printing Printing N-560 Real-Time Data Real-time data is continuously sent to the data port on the back of the N-560. Patient data can be obtained through the data port by connecting to a computer or serial printer. When a real-time printout or display is being transmitted to a printer or computer, a new line is printed/displayed every 2 seconds. Column headings are printed/ displayed every 25 lines, or if one of the values in the column heading is changed.
Printing 1. Connect the serial printer to the N-560's Data Port connector (1). 2. Turn on the printer. 3. Connect the N-560 to an AC outlet. 4. Turn on the N-560. The printer will start printing real time trend data or the PC will start displaying real time data at a rate of one line every 2 seconds.
Printing Trend Data Printout The format of data displayed when a trend printout is requested is the same as the real-time data. The only differences are that “TREND” is displayed in the top row instead of the “CRC: XXXX” software verification number and there is no “Status” column. Readings are displayed in 4-second intervals. The values on each row are an average for the 4-second period. At the end of the printout, an “Output Complete” line indicates that the transmission was successful.
Printing Column Headings Column headings are displayed or printed after every 25 lines, or if one of the values in the column heading changes. Data Source Data in the highlighted box above represents the model number of the N-560, in this case the N-560. Device/Software Revision Level The next data field tells the user the software level (Version 1.00.00) and a software verification number (CRC: XXXX). Neither of these numbers should change during normal operation.
Printing The last data field in the top line indicates the upper and lower alarm limits for %SpO2 and for the pulse rate (PR), and the SatSeconds alarm setting (OFF). The SatSeconds setting may be OFF, 10, 25, 50, or 100 depending on the SatSeconds alarm setting. In the example above, the low alarm limit for SpO2 is 85% and the upper alarm limit is 100%. Pulse Rate alarm limits are 40 to 170 bpm. SatSeconds alarm limit is set to off. N-560 Mode The N-560 mode is ADULT.
Printing The Time column represents the N-560 real-time clock. Refer to the N-560 service manual to set the N-560 real-time clock. Patient Data Patient data is highlighted in the display above. Parameter values are displayed directly beneath the heading for each parameter. In this example, the %SpO2 is 100, and the pulse rate is 190 beats per minute. An asterisk indicates that the parameter is outside the set limits. If no data for a parameter is available, three dashes (- - -) are displayed.
Printing Code Meaning AO Alarm Off AS Alarm Silence LB Low Battery LM Loss of Pulse w/Interference LP Loss of Pulse MO Interference Detected PH Pulse Rate Upper Limit Alarm PL Pulse Rate Lower Limit Alarm PS Pulse Search SH Saturation Upper Limit Alarm SL Saturation Lower Limit Alarm SD Sensor Disconnect SO Sensor Off Note: A sensor disconnect and sensor off will also cause three dashes ( - - - ) to be displayed in the patient data section of the printout.
Printing 62
Sensors and Accessories Sensors and Accessories 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 pulse oximetry cable. Do not use a sensor with exposed optical components. WARNING: Use only Nellcor sensors and pulse oximetry cables with the N-560. Other sensors or pulse oximetry cables may cause improper N-560 performance.
Sensors and Accessories WARNING: Do not immerse or wet the sensor. When selecting a sensor, consider the patient's weight and activity level, the adequacy of perfusion and the available sensor sites, the need for sterility, and the anticipated duration of monitoring. For more information, refer to Table 2 or contact your local Nellcor representative. For a complete and up-to-date listing of all sensors applicable to the N-560, refer to the Sensor Accuracy Grid posted on the Internet at: http://www.
Sensors and Accessories Table 2: Nellcor Oximetry Sensor Models and Patient Weights (Cont.) OXIMAX Sensor Model Patient Size1 OXIMAX adhesive sensor, single-patient-use, infant MAX-I 3 to 20 kg (6.
Sensors and Accessories Biocompatibility Testing Biocompatibility testing has been conducted on Nellcor OxiMax sensors in compliance with ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. The OxiMax sensors have passed the recommended biocompatibility testing and are therefore in compliance with ISO 10993-1. Optional Accessories Several optional accessories are offered with the N-560. Contact Nellcor's Technical Services Department, 1.800.635.
Sensors and Accessories 1. Visual alarm indicator Pole Mount Bracket An optional pole mount bracket is available for the N-560. The pole mount bracket may be used to attach the N-560 to an IV pole. The pole mount bracket is attached to the rear of the N-560.
Sensors and Accessories 68
Performance Considerations Performance Considerations WARNING: Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. See the appropriate sections of the manual for specific safety information. Performance Verification The performance of the N-560 can be verified by following the procedures outlined in the Performance Verification section of the N-560 service manual.
Performance Considerations Dysfunctional Hemoglobins Dysfunctional hemoglobins such as carboxyhemoglobin, methemoglobin, and sulphemoglobin are unable to carry oxygen. SpO2 readings may appear normal; however, a patient may be hypoxic because less hemoglobin is available to carry oxygen. Further assessment beyond pulse oximetry is recommended. Anemia Anemia causes decreased arterial oxygen content. Although SpO2 readings may appear normal, an anemic patient may be hypoxic.
Performance Considerations • ambient light • excessive patient movement Loss-of-pulse signal can occur for the following reasons: • the sensor is applied too tightly • a blood pressure cuff is inflated on the same extremity as the one with the sensor attached • there is arterial occlusion proximal to the sensor Use only Nellcor sensors and sensor cables.
Performance Considerations Caution: Failure to cover the sensor site with opaque material in high ambient light conditions may result in inaccurate measurements. If patient movement presents a problem, try one or more of the following remedies to correct the problem.
Operator’s Menu Operator’s Menu This operator’s menu (Table 3) provides a quick reference to the functions on the N-560. The functions that are in Bold are the default settings.
Operator’s Menu 74
Troubleshooting 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 N-560 is functioning correctly. WARNING: The cover should be removed only by qualified service personnel. There are no user-serviceable parts inside. CAUTION: Do not spray, pour, or spill any liquid on the N-560, its accessories, connectors, switches, or openings in the chassis.
Troubleshooting Table 4: Error Codes Error Code Action 513 1 — Charge the battery. 2 — Notify service personnel. 514 1 — Restart the N-560. 2 — Notify service personnel. 525 1 — Restart the N-560. 2 — Notify service personnel. 526 1 — Restart the N-560. 2 — Notify service personnel. 528 1 — Restart the N-560. 2 — Notify service personnel.
Troubleshooting • If the N-560 is operating on AC power, the fuse may be blown. Notify service personnel to check and, if necessary, replace the fuse. • If the N-560 is on battery power, the battery fuse may require replacement, the battery may be missing, or the battery may be discharged. Charge the battery or notify service personnel to replace the battery or the battery fuse, as required. 2. One or more display segments or indicators do not light during the power-on self-test.
Troubleshooting • Interference may be preventing the N-560 from tracking the pulse. Verify that the OXIMAX sensor is securely applied and replace it if necessary. Change the OXIMAX sensor site. Use a type of OXIMAX sensor that maintains better contact with the patient’s skin, such as an adhesive OXIMAX sensor. • Electromagnetic interference may be preventing the N-560 from tracking the pulse. Remove the source of interference (e.g., isolate the electromagnetic source or stabilize the sensor site).
Troubleshooting with a blood pressure cuff, arterial catheter, or intravascular line. Reposition the sensor, as necessary. 6. The letters EEE, followed by a number, appear on the display. • This is an error code. To confirm, press the Power On/Off button to turn the N-560 off, then press the button again to turn it back on. If the display shows the error code once again, record the number and provide that information to qualified service personnel, or your local Nellcor representative.
Troubleshooting The N-560 is designed for use in environments in which the pulse can be obscured by electromagnetic interference. During such interference, measurements may seem inappropriate or the N-560 may not seem to operate correctly. Disruption may be evidenced by erratic readings, cessation of operation, or other incorrect functioning.
Troubleshooting The most recent revision of this manual and the service manual are available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ ProductManuals.
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Maintenance Maintenance CAUTION: Follow local governing ordinances and recycling instructions regarding the disposal or recycling of device components and accessories. Returning the N-560 Contact Nellcor’s Technical Services Department, 1.800.635.5267, or your local Nellcor representative for shipping instructions including a Returned Goods Authorization (RGA) number.
Maintenance 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. Cleaning CAUTION: Do not spray, pour, or spill any liquid on the N-560, its accessories, connectors, switches, or openings in the chassis.
Technical Information Technical Information Description of Alarms The N-560 has three levels of audible alarms. 1. High-priority alarm: A high-pitched, fast-pulsating tone indicating loss of pulse with no patient motion. 2. Medium-priority alarm: A medium-pitched, normal-pulsating tone indicating an SpO2 or pulse rate limit violation. During a medium-priority alarm, the green display turns red and flashes with the patient parameter that violated the limit (%SpO2 or Pulse Rate).
Technical Information Factory Defaults The N-560 is shipped with factory default settings. Authorized technical personnel using the procedures described in the N-560 service manual can change default settings.
Technical Information Table 5: Factory Default Settings (Cont.) Parameter Silence Alarms Range 0, 1 Factory Default Setting 1 (Off) SatSeconds Display When the N-560 SatSeconds technology detects an SpO2 value outside the alarm limit, the SatSeconds indicator LEDs begin to light (fill) clockwise. When the SpO2 value is within the set limits, the SatSeconds indicator LEDs will extinguish counterclockwise.
Technical Information The SatSeconds limit controls the time that the %SpO2 level may fall below the alarm limit before an audible alarm sounds. The method of calculation is as follows: The number of percentage points that the %SpO2 falls outside the alarm limit is multiplied by the number of seconds that the %SpO2 level remains outside that limit.
Technical Information Figure 6: 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, reentering the non-alarm range several times. During such fluctuation, the N-560 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.
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Principles of Operation Principles of Operation Oximetry Overview The N-560 uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed, such as a finger or toe. The sensor contains a dual light source and a photo detector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time.
Principles of Operation point. The N-560 bases its SpO2 measurements on the difference between maximum and minimum absorption (measurements at systole and diastole). By doing so, it focuses on light absorption by pulsatile arterial blood, eliminating the effects of nonpulsatile absorbers such as tissue, bone, and venous blood. There are various matrixes within the OXIMAX algorithm. Some are used to assess the severity of conditions presented to the N-560 in measuring SpO2 and pulse rate.
Principles of Operation Functional versus Fractional Saturation This N-560 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, hemoximeters such as the IL482 report fractional saturation -- oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobins.
Principles of Operation Measured versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen (PO2), the calculated value may differ from the SpO2 measurement of a pulse oximeter. This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO2 and pH, temperature, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin. See Figure 7.
Principles of Operation accuracy of the SpO2 measurements requires, at a minimum, accommodating the wavelength characteristics of the sensor and reproducing the complex optical interaction of the sensor and the patient’s tissue. These capabilities are beyond the scope of known bench top testers.
Principles of Operation 96
Specifications Specifications Performance Measurement Range SpO2 1% to 100% Pulse Rate 0 and 20 beats per minute (bpm) to 250 bpm Perfusion Range 0.03% to 20% Accuracy and Interference Tolerance Saturation Adults1 70 to 100% ±2 digits Neonate 70 to 100% ±3 digits Low Perfusion2 70 to 100% ±2 digits Pulse Rate Adult and Neonate1 20 to 250 bpm ±3 digits Low Perfusion2 20 to 250 bpm ±3 digits 1 Adult specifications are shown for OXIMAX MAX-A and MAX-N sensors with the N-560.
Specifications Table 6: Tone Definition Audible Indicator Alarm Silence Reminder Confirmation of Button Pressed High Priority Alarm Parameter Value Volume level Not changeable Pitch (±30 Hz) 784 Hz Pulse width (±20 ms) 150 ms Pulse repetition interval (±20 ms) (double burst) 150 ms Repetitions 3 Volume level Not changeable Pitch (±30 Hz) 784 Hz Pulse width (±20 ms) 150 ms Pulse repetition interval (±20 ms) (double burst) 150 ms Repetitions 3 Volume level Adjustable alarm volume P
Specifications Table 6: Tone Definition (Cont.
Specifications Table 6: Tone Definition (Cont.
Specifications Electrical Instrument Power Requirements 100 to 240 volts AC, 25 to 39 volt/amps to be compliant with IEC 60601-1 sub-clause 10.2.2 Fuses qty 2, 2 A, 250 volts, slow-blow, IEC (5 x 20 mm) Battery The battery provides at least eight hours of battery life when new and fully charged with no alarms, no serial data, while using a pulse simulator set for 60 bpm, high light and low modulation. Type Nickel metal hydride Voltage 9.6 volts DC, 3.
Specifications Environmental Conditions Operation Temperature 50 ºF to 113 ºF (10 ºC to 45 ºC) Altitude/Barometric Pressure -390 m to 3,012 m (-1,280 ft. to 9,882 ft.) 70 kPa to 106 kPa (20.6 in. Hg to 31.3 in. Hg) Relative Humidity 15% to 95% non-condensing to be compliant with IEC 60601-1, sub-clause 44.5 Transport and Storage (not in shipping container) -4 ºF to 140 ºF (-20 ºC to 60 ºC) Temperature Altitude/Barometric Pressure -390 m to 5,574 m (-1,280 ft. to 18,288 ft.
Specifications Sensor Power Dissipation (Cont.) Sensor Dissipation OXIMAX MAX-P 52.5 mW OXIMAX MAX-A 52.5 mW OXIMAX MAX-AL 52.5 mW OXIMAX MAX-R 52.5 mW OXIMAX Oxiband OXI-A/N 52.5 mW OXIMAX Oxiband OXI-P/I 52.5 mW OXIMAX Durasensor DS-100A 52.5 mW OXIMAX OxiCliq P 52.5 mW OXIMAX OxiCliq N 52.5 mW OXIMAX OxiCliq I 52.5 mW OXIMAX OxiCliq A 52.5 mW OXIMAX Dura-Y D-YS 52.5 mW OXIMAX MAX-FAST 52.5 mW OXIMAX Softcare SC-PR 52.5 mW OXIMAX Softcare SC-NEO 52.
Specifications Physical Characteristics Weight 3.07 lbs. (1.39 kg) without pole mount Dimensions 2.95 " (H) × 9.06 " (W) × 5.04" (D) 75 mm (H) × 230 mm (W) × 128 mm (D) Compliance Item 104 Standard Description Quality System EN ISO 13485: 2000, ISO 13485: 1996 Quality system — Medical Devices, Particular Requirements for application of ISO 9001: 2000 EC Directive 93/42/EEC Medical Device Directive (Europe + Int.) FDA Guidance FDA RG (Nov.
Specifications Item Standard Description Safety ISO 9919: 2005(E) Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. EMC EN 60601-1-2 Medical Electric Equipment, Collateral Standard: EMCRequirements and Test, 2nd Edition, 2001 EMC EN 55011, Class B/ Group 1 EMC Disturbance Characteristics — Limits and Methods of Measurement, Industrial Scientific and Medical (ISM) RF Equipment, Edition 3.
Specifications Manufacturer’s Declaration This product complies with EN/IEC 60601-1-2:2001. WARNING: The use of accessories, sensors, and cables other than those specified may result in increased emission and/or create invalid readings of the N-560. Table 7: Cable Compliance Cables Comply With: • RF emissions, EN 55011, Class B/Group 1 • EN 60601-1-2; 2001 Cables and OxiMax Sensors 106 Maximum Length OxiCliq-OC-3 cable 3 ft. (0.9 m) DOC-10 pulse oximeter cable 10 ft. 10 in. (3.
Specifications Table 7: Cable Compliance (Cont.) Cables Comply With: (Cont.) • RF emissions, EN 55011, Class B/Group 1 • EN 60601-1-2; 2001 Cables and OxiMax Sensors (Cont.) Maximum Length MAX-P sensor 1.5 ft. (0.5 m) MAX-R sensor 1.5 ft. (0.5 m) SC-PR sensor 3 ft. (0.9 m) SC-NEO sensor 3 ft. (0.9 m) SC-A sensor 3 ft. (0.9 m) DS-100A sensor 3 ft. (0.9 m) OXI-A/N sensor 3 ft. (0.9 m) OXI-P/I sensor 3 ft. (0.9 m) D-YS sensor 4 ft. (1.2 m) D-YSE sensor 4 ft. (1.2 m) D-YSPD sensor 4 ft.
Specifications Table 8: Electromagnetic Emissions The N-560 is intended for use in the electromagnetic environment specified below. The customer or the user of the N-560 should assure that it is used in such an environment.
Specifications Table 9: Electromagnetic Immunity (Cont.) The N-560 is intended for use in the electromagnetic environment specified below. The customer or user of the N-560 should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment — Guidance Surge IEC 61000-4-5 ±1 kV differential mode ±2 kV common mode Complies Mains power quality should be that of a typical commercial or hospital environment.
Specifications Table 9: Electromagnetic Immunity (Cont.) The N-560 is intended for use in the electromagnetic environment specified below. The customer or user of the N-560 should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Conducted RF IEC 61000-4-6 3 Vrms 150 kHZ to 80 MHz 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.
Specifications Table 9: Electromagnetic Immunity (Cont.) The N-560 is intended for use in the electromagnetic environment specified below. The customer or user of the N-560 should assure that it is used in such an environment.
Specifications Table 10: Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the N-560 The N-560 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Index Symbols C %SpO2 display 9 Calculated saturation 94 Calibration, automatic 92 Components, list of 16 Connecting a sensor 17 Connecting to the data port 47 Corrective action 76 A AC power indicator 9 Adjust down button 8 Adjust up button 8 Alarm limits, setting 35 Alarm off 61 Alarm priorities 85 Alarm silence 61 Alarm silence button 8 Alarm silence duration, setting 29 Alarm silence indicator 10 Alarm volume, setting 28 Anemia 70 AO 61 AS 61 Audible indicators 13 Audio alarms, disabling 31 Automati
Index H Hospital type environments 3 I interference detected 61 Interference indicator 10 L LB 61 LM 61 Loss of pulse 61 loss of pulse with Interference 61 Low battery 61 Low battery indicator 9 LP 61 M Measured saturation 94 MO 61 Monitor accuracy and interference tolerance 97 measurement range 97 relative humidity 102 temperature 102 Operator’s menu 73 Oximetry overview 91 P Patient settings, verifying 32 Performance considerations 69 Performance verification 69 PH 61 PL 61 Print, trend 44 Printing tren
Index Selecting a sensor 63 Sen Err 75 Sensor disconnect 61 Sensor messages indicator 11 Sensor off 61 Sensor off indicator 10 sensor power dissipation 102 Sensor, selecting 63 Service 83 Setting pulse beep volume 27 SH 61 Shut down, automatic 19 SL 61 SO 61 Specifications 97 performance 97 specifications battery 101 compliance 106 electrical 101 electrical, instrument 101 N-560 Operator’s Manual environmental 102 physical 104 storage altitude 102 barometric pressure 102 relative humidity 102 temperature
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