Nellcor N-560 Pulse Oximeter Operator's Manual PDF

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Nellcor pulse oximeter medical device manual pulse oximetry medical equipment

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This document is a user manual for the Nellcor N-560 Pulse Oximeter, a medical device used for monitoring oxygen saturation in patients. It explains the device's features, functions, and safety precautions. It also covers topics like setting up the device, connecting sensors, and troubleshooting common issues.

Full Transcript

Ops.ai 1/24/06 9:31:41 AM C M Y CM MY CY CMY K This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 Canada. Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, OxiBand, Dura-Y, MAX...

Ops.ai 1/24/06 9:31:41 AM C M Y CM MY CY CMY K This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 Canada. Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, OxiBand, Dura-Y, MAX-FAST, SatSeconds, PediCheck, Oxismart and OXIMAX are trademarks of Nellcor Puritan Bennett Inc. To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department, or your local representative. Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett. Covered by one or more of the following US patents and foreign equivalents: 4,802,486; 4,869,254; 4,928,692; 4,934,372; 4,960,126; 5,078,136; 5,485,847; 5,743,263; 5,865,736; 6,035,223; 6,298,252; 6,463,310; 6,591,123; 6,675,031; 6,708,049; 6,801,797; Re 35,122. Contents Contents.....................................................i Figures..................................................... v Tables......................................................vi Safety Information............................................ 1 Warnings................................................................................................................1 Cautions.................................................................................................................2 Notes......................................................................................................................3 Introduction................................................. 5 Intended Use for the N-560....................................................................................5 How to Use this Manual.........................................................................................6 Description of Controls, Indicators, and Symbols.................. 7 Identification of Front Panel Buttons and Symbols................................................7 Identification of Rear Panel Components...............................................................8 N-560 Symbols.......................................................................................................8 Description of Controls...........................................................................................9 Description of Displays and Indicators.................................................................11 Interference Explained....................................................................................13 Description of Audible Indicators..........................................................................15 Setting up the N-560.......................................... 17 List of Components..............................................................................................18 Connecting the N-560 to AC Power.....................................................................19 Connecting a Sensor to the N-560.......................................................................19 Battery Operation............................................ 21 Operating the N-560 on Battery Power................................................................21 Low Battery Indicator...........................................................................................22 Using the N-560............................................. 23 Turning on the N-560...........................................................................................23 Discussion.......................................................................................................23 Procedure........................................................................................................24 Sensor Attached..............................................................................................26 N-560 Operator’s Manual i Contents No Sensor Attached........................................................................................ 28 Sensor Message.................................................................................................. 28 Setting the Pulse Beep Volume........................................................................... 29 Setting the Alarm Volume.................................................................................... 30 Setting Alarm Silence Duration............................................................................ 30 Discussion....................................................................................................... 30 Procedure....................................................................................................... 31 Disabling Audible Alarms..................................................................................... 32 Discussion....................................................................................................... 32 Procedure....................................................................................................... 32 Verify Patient Settings......................................................................................... 33 Alarm Limits Changed Indicator.......................................................................... 35 Setting Alarm Limits............................................................................................. 36 Discussion....................................................................................................... 36 Procedure....................................................................................................... 36 Setting SatSeconds Duration.............................................................................. 38 Discussion....................................................................................................... 38 Procedure....................................................................................................... 38 Setting the Data Port Baud Rate......................................................................... 39 Discussion....................................................................................................... 39 Procedure....................................................................................................... 39 Setting the Data Port Protocol............................................................................. 41 Clearing Trend Information.................................................................................. 42 N-560 Trend.................................................45 Trend Data Operation.......................................................................................... 45 Trend Data........................................................................................................... 46 #1: Trend Print................................................................................................ 46 #2: Trend Clear............................................................................................... 46 #3: Not Used................................................................................................... 46 #4: Baud Rate................................................................................................. 47 #5: Data Port Printout..................................................................................... 47 Option 1................................................................................................... 47 Option 2................................................................................................... 47 Using the Data Port...........................................49 Overview.............................................................................................................. 49 ii Contents Connecting to the Data Port.................................................................................49 Data Port Pinouts.................................................................................................50 Data Port Setup....................................................................................................51 Discussion.......................................................................................................51 Procedure........................................................................................................52 Nurse Call Interface.............................................................................................55 Setting Nurse Call RS-232 Polarity.................................................................56 Setting Nurse Call Relays Normally Open/Closed..........................................56 Printing.................................................... 59 Printing N-560 Real-Time Data............................................................................59 Trend Data Printout..............................................................................................61 Column Headings............................................................................................62 Data Source....................................................................................................63 Device/Software Revision Level......................................................................63 Alarm Limits.....................................................................................................63 N-560 Mode.....................................................................................................64 Data Column Headings...................................................................................64 Time................................................................................................................64 Patient Data.....................................................................................................65 Operating Status.............................................................................................65 Sensors and Accessories..................................... 67 Selecting a Sensor...............................................................................................67 Biocompatibility Testing.......................................................................................70 Optional Accessories...........................................................................................70 Visual Alarm Indicator.....................................................................................70 Pole Mount Bracket.........................................................................................71 Performance Considerations.................................. 73 Performance Verification......................................................................................73 N-560 Performance Considerations.....................................................................73 Dysfunctional Hemoglobins.............................................................................74 Anemia............................................................................................................74 Saturation........................................................................................................74 Pulse rates......................................................................................................74 Sensor Performance Considerations...................................................................74 N-560 Operator’ Manual iii Contents Operator’s Menu.............................................77 Troubleshooting.............................................79 Error Codes......................................................................................................... 79 Corrective Action................................................................................................. 80 EMI (Electro-magnetic Interference).................................................................... 83 Obtaining Technical Assistance.......................................................................... 84 Maintenance.................................................87 Returning the N-560............................................................................................ 87 Service................................................................................................................. 87 Periodic Safety Checks....................................................................................... 88 Cleaning.............................................................................................................. 88 Technical Information.........................................89 Description of Alarms.......................................................................................... 89 Factory Defaults.................................................................................................. 90 SatSeconds Display............................................................................................ 91 Describing SatSeconds....................................................................................... 92 SatSeconds “Safety Net”..................................................................................... 94 Principles of Operation........................................95 Oximetry Overview.............................................................................................. 95 Automatic Calibration.......................................................................................... 96 Functional versus Fractional Saturation.............................................................. 97 Measured versus Calculated Saturation.............................................................. 97 Functional Testers and Patient Simulators.......................................................... 98 Specifications..............................................101 Performance...................................................................................................... 101 Electrical............................................................................................................ 105 Environmental Conditions.................................................................................. 106 Physical Characteristics.................................................................................... 108 Compliance........................................................................................................ 108 Manufacturer’s Declaration................................................................................ 111 Index......................................................119 iv Figures Figure 1: Front Panel Buttons and Symbols......................................................... 7 Figure 2: Rear Panel Symbols.............................................................................. 8 Figure 3: Data Port Pin Layout............................................................................ 51 Figure 4: Real-Time Data Printout...................................................................... 61 Figure 5: Trend Data Printout............................................................................. 62 Figure 6: Alarm Response with SatSeconds...................................................... 93 Figure 7: Oxyhemoglobin Dissociation Curve..................................................... 98 N-560 Operator’s Manual v Ta b l e s Table 1: Data Port Pinouts................................................................................... 50 Table 2: Nellcor Oximetry Sensor Models and Patient Weights........................... 68 Table 3: Operator’s Menu.................................................................................... 77 Table 4: Error Codes............................................................................................ 80 Table 5: Factory Default Settings......................................................................... 90 Table 6: Tone Definition..................................................................................... 102 Table 7: Cable Compliance................................................................................ 111 Table 8: Electromagnetic Emissions.................................................................. 113 Table 9: Electromagnetic Immunity.................................................................... 114 Table 10: Electromagnetic Immunity.................................................................... 116 Table 11: Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the N-560.................... 118 vi 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. See the appropriate sections of the manual for specific safety information. WARNING: Ensure that the speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm tone. N-560 Operator’s Manual 1 Safety Information Cautions Cautions are identified by the CAUTION symbol shown above. Cautions alert the user to exercise care necessary for the safe and effective use of the N-560. 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. Anyone who connects additional equipment to the signal input port or signal output port (N-560 data port connector) configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC Standard 60601-1-1 and the electromagnetic compatibility system standard IEC Standard 60601-1-2. The N-560 accuracy may degrade if it is connected to secondary I/O devices when the instrument is not connected to earth reference. CAUTION: Do not lift the N-560 by the sensor cable or power cord because the cable or cord could disconnect from the N-560, causing damage to the N-560 or injuring the patient. CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. 2 Safety Information Notes Notes are identified by the Note symbol shown above. Notes provide additional useful information. Note: Sensor LED light emissions fall within Class 1 level, according to IEC 60825-1:2001. No special safety precautions are required. N-560 Operator’s Manual 3 Safety Information 4 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. The N-560 is intended for use with neonatal, pediatric, and adult patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only. Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office -based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers. Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility. Use with any particular patient requires the selection of an appropriate oxygen transducer (sensor) as described in this Operator's Manual. N-560 Operator’s Manual 5 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.html 6 Description of Controls, Indicators, and Sym- Desc ription of Controls, Indic ators , and Symbols Identification of Front Panel Buttons and Symbols Figure 1: Front Panel Buttons and Symbols 1 — SpO 2Sensor Port SatSeconds Alarm Limit 12 — Button 2 — Power On/Off Button 13 — SpO2 Alarm Limit Button 3 — %SpO2 Display 14 — Interference Indicator 4 — Pulse Amplitude 15 — Sensor OffIndicator Indicator 5 — Pulse Rate Display 16 — Sensor Message Indicator 6 — Alarm Silence Button 17 — Pulse Search Indicator 7 — Alarm Silence Indicator 18 — Data In SensorIndicator 8 — Adjust Up Button 19 — Low BatteryIndicator 9 — Adjust Down Button 20 — AC Power Indicator 10 — Pulse Rate Alarm 21 — Speaker Limit Button 11 — SatSecondsTM Display N-560 Operator’s Manual 7 Description of Controls, Indicators, and Symbols Identification of Rear Panel Components 1 — Data Port Connector 3 — AC Power Connector 2 — Visual Alarm 4 — Equipotential Connector 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 3 — Equipotential Terminal (ground) 2 — Caution - Do not connect while power is on 8 Description of Controls, Indicators, and Sym- The symbols that are located on the front panel of the N-560 are as follows: 1 — Type BF Applied Part - 6 — Pulse Search Not Defibrillator Proof 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. If the button pressed fails to emit a tone, contact qualified service personnel. The Power On/Off button is used to turn the N-560 on or off. N-560 Operator’s Manual 9 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. The Adjust Up button is used to select the communication protocol and time settings. Press the Adjust Up button one time to increase the display by one digit. Holding the Adjust Up button down for more than one second cause the display digits to scroll. The Adjust Down button is used to decrease alarm limit values, alarm silence duration, pulse beep volume, alarm volume, and data port baud rate. The Adjust Down button is used to select the communication protocol and time settings. Press the Adjust Down button one time to decrease the display by one digit. Holding the Adjust Down button down for more than one second cause the display digits to scroll. The SpO2 Alarm Limit button is used to view the SpO2 alarm limit. When the SpO2 Alarm Limit button is pressed at the same time as the Pulse Rate Alarm Limit button for approximately three seconds, the menu options are enabled. The Pulse Rate Alarm Limit button is used to view the pulse rate alarm limit. When the Pulse Rate Alarm Limit button is pressed at the same time as the SpO2 Alarm Limit button for approximately three seconds, the menu options are enabled. The SatSeconds Alarm Limit button is used to view the SatSeconds alarm limit. When pressed, the limit options are enabled. The SatSeconds Adjust Up and Adjust Down buttons are used to change the SatSeconds limit settings. 10 Description of Controls, Indicators, and Sym- 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. The display value flashes zero during loss-of-pulse alarms and flashes the SpO2 value in red when the SpO2 is outside the alarm limits. During pulse search, the N-560 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 Rate Display. Shows the pulse rate in beats per minute. It flashes zeros during loss-of-pulse alarms and flashes the beats per minute value in red when the pulse rate is outside of the alarm limit. During pulse search, the N-560 continues to update the display. Pulse rates outside of the pulse rate range (20 to 250 bpm) are displayed as the closest value within the range. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the pulse rate value (112.). The AC Power Indicator. Lights continuously when the N -560 is connected to AC power. It also indicates that the battery is charging. It is off when the N-560 is being powered by its internal battery. The Low Battery Indicator. Lights continuously to indicate that 15 or fewer minutes of battery capacity remain. The Low Battery indicator flashes when the battery is critically low. N-560 Operator’s Manual 11 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 XI AX software O M detects that the incoming signal quality is degraded due to interference (seeInterference Explained on page 13). An intermittently lit Interference indicator is common during patient monitoring, and indicates that the XI AX algorithm is dynamically O M adjusting the amount of data required for measuring SpO2 and Pulse Rate. When lit continuously, it indicates that the XI AX algorithm has O M extended the amount of data required for measuring SpO2 and Pulse Rate, and, consequently, fidelity in tracking rapid changes in these values may be reduced (see Description of Displays and Indicators on page 11). The Pulse Search Indicator. Lights continuously prior to initial acquisition of a pulse signal and during prolonged and challenging monitoring conditions. It flashes during a loss-of-pulse signal. The Sensor Off Indicator is lit when either the sensor is invalid, or no longer on the patient’s finger. It usually indicates that the sensor is not on the patient. The Sensor Message Indicator. Lights when the N-560 cannot determine an SpO2 level or a pulse rate. The sensor message recommendations for improving the signal are: Reposition sensor Check or change adhesive wrap Choose alternate site Warm site Cover sensor Use forehead, nasal, or ear sensor (adult patients only) Use XI AX adhesive sensor O M Secure cable Secure with headband ( AX- AST) M F Remove nail polish 12 Description of Controls, Indicators, and Sym- 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 OXIM AX sensor contains a patient sensor event record. The indicator lights continuously to indicate that the attached sensor memory is full. The indicator does not light when there is no data in the sensor, even though a valid sensor is connected to the N-560. The SatSecondsTM Indicator. Fills in clockwise as the SatSeconds alarm management approaches the SatSeconds alarm limit threshold. All segments of the SatSeconds indicator flash during a SatSeconds alarm. When a SatSeconds setting other than OFF is selected, the green LED at the top of the SatSeconds indicator will light. The green LED at the 12-o'clock position indicates that SatSeconds alarm management is engaged. Interference Explained Interference is a term that was formally introduced in ISO9919:2005, “Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use”. Interference may arise from a number of sources, alone or in combination, and the term refers to the effects on the incoming red and IR signals caused by physiological conditions, medical procedures, or external agents. The effect of interference on a pulse oximeter is due only to the amount of interference, and is generally non-discriminatory as to its source. Interference may or may not affect the accuracy of measurements, depending upon its severity, nature, or duration. Factors which may result in interference include but is not limited to: incorrect sensor application N-560 Operator’s Manual 13 Description of Controls, Indicators, and Symbols – 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 opaque material in high ambient light conditions, for example, conditions created from one or more of the following sources: – surgical lights, especially xenon light sources – bilirubin lamps – fluorescent lights – infrared heating lamps – direct sunlight physical movement, either patient or imposed activity venous pulsation dysfunctional hemoglobin low perfusion intermittent pulsatility or arrhythymia electromagnetic interference (EMI) ventilator-induced pressure changes 14 Description of Controls, Indicators, and Sym- Description of Audible Indicators Follow ing are descriptions of N - 560 audible indicators. Power-On Self-Test A 1-second tone indicating that the N-560 Pass has been turned on and has successfully completed the power-on self-test Valid Button Press A short, medium -pitched tone indicating that an appropriate button has been pressed Invalid Button Press A short, low -pitched tone indicating that a button has been pressed that is not appropriate for the current state of the N-560 High Priority Alarm A high-pitched, fast-pulsating tone indicating loss of pulse Medium Priority A medium -pitched, normal-pulsating tone Alarm indicating an SpO2 or pulse rate limit violation Low Priority Alarm A low -pitched, slow -pulsating tone indicating a sensor disconnect, low battery, or N-560 failure Alarm Silence Three beeps that sound approximately Reminder 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. Volume Setting Tone A continuous tone that is used to adjust the alarm volume Confirmation Tone Three beeps sound to indicate that default settings have been saved or reset to factory defaults or trend data has been deleted N-560 Operator’s Manual 15 Description of Controls, Indicators, and Symbols 16 Setting up the N-560 Se tting 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. WARNING: To ensure patient safety, do not place the N-560 in any position that might cause it to fall on the patient. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: Disconnect the N-560 and Nellcor sensor from the patient during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The N-560 may affect the MRI image; the MRI unit may affect the accuracy of oximeter measurements. WARNING: To ensure accurate performance and prevent device failure, do not subject the N-560 to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure. N-560 Operator’s Manual 17 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. 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. Do not attach any cable that is intended for computer use to the sensor port. Do not connect any device other than a Nellcor-approved sensor to the sensor connector. List of Components 1 — N -560 Pulse Oximeter 1 — Nellcor Sensor or Assortment Pack 1 — DOC-10 Pulse Oximeter Cable 1 — N -560 Operator's Manual 1 — Hospital-Grade Power Cord or power cord appropriate for country of sale 1 — Sensor Accuracy Grid 1 — Quick Guide 18 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. 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. N-560 Operator’s Manual 19 Setting up the N-560. 1 — SpO 2 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. 20 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. Note: Whenever the N-560 is connected to AC power, the battery is being charged. Therefore, it is recommended that the N-560 remain connected to AC power when not in use. This will make a fully charged battery available for use at any time. The N-560 cannot operate with a dead battery. Before attempting to turn on an N-560 with a depleted battery, first plug the N-560 into an AC outlet. The N-560 may then be powered on. To charge a low or dead battery, connect the N-560 to AC power. A full charge of a dead battery takes 6 hours. When all of the following conditions are present for 15 minutes, the N-560 will automatically shut down: N-560 is running on battery power No buttons have been pressed No pulse has been detected (for example, when no patient is connected to the sensor or the sensor is disconnected) No alarms are present (other than low battery or a non-correctable error) N-560 Operator’s Manual 21 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. Note: As the battery is used and recharged over a period of time, the amount of time between the onset of the low battery alarm and the N-560 shut-off may become shorter. It is recommended that qualified service personnel replace the internal battery every 24 months. CAUTION: If the N-560 is to be stored for 2 months or longer, notify service personnel to remove the battery from the N-560 prior to storage. Recharge the battery when it has not been charged for 2 or more months. The Low Battery Indicator flashes and a high priority alarm begins to sound when the battery reaches the lowest battery voltage at which an N-560 can support normal operation. This alarm cannot be silenced while running on battery power. If the N-560 is not connected to AC power, the N-560 will shut off after 10 seconds. 22 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. If adjacent or stacked use is necessary, the N-560 should be observed to verify normal operation in the configuration in which it is used. CAUTION: If any indicator or display element does not light, or the speaker does not sound, do not use the N-560. Instead, contact qualified service personnel, your local Nellcor representative, or Nellcor's Technical Services Department, 1.800.635.5267. Note: The N-560 should complete the POST function within 12 seconds. N-560 Operator’s Manual 23 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. CAUTION: During POST (immediately after power-up), confirm that all display segments and indicators light, and the speaker sounds a 1-second pass tone. 24 Using the N-560 4. While performing POST, the self-test display appears for approximately 2 to 4 seconds. During this time: 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. Device version numbers are often needed when calling Nellcor's Technical Services Department, 1.800.635.5267, or your local Nellcor representative for technical assistance. Write down the numbers and have them available prior to requesting technical assistance. N-560 Operator’s Manual 25 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 79. 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. Failure to do so could result in an inaudible alarm tone. Note: In addition to serving as the POST pass verification, the POST pass tone also functions as an audible confirmation that the speaker is performing properly. If the speaker does not function, the alarm sounds cannot be heard. Sensor Attached The Pulse Search indicator and the Sensor Off indicator light and the N-560 displays dashes in the %SpO2 and Pulse Rate displays while the N-560 is searching for a valid pulse. 26 Using the N-560 1 —Sensor Off 2 — Pulse Search Indicator When a valid pulse is detected, the N-560 enters the Monitoring Mode and displays patient parameters. Look for movement of the blip bar and, if the pulse beep volume is not 0, listen for pulse beeps to verify that displayed measurement values are current and accurate. 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. N-560 Operator’s Manual 27 Using the N-560 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. The Sensor Message indicator lights when the N-560 cannot determine an SpO2 level or a pulse rate. The Sensor Message recommendations for improving the signal are: Reposition sensor Check or change adhesive wrap Choose alternate site Warm site Cover sensor Use forehead, nasal, or ear sensor (adult patients only) Use OXIMAX adhesive sensor Secure cable Secure with headband (MAX-FAST) Remove nail polish Loosen sensor (too tight) Isolate external interference (electrosurgical device, cell phone) Clean site (MAX-R) 28 Using the N-560 Setting the Pulse Beep Volume 1 — SpO 2 Sensor Port WARNING: Use only Nellcor-approved sensors and sensor cables. 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. 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. N-560 Operator’s Manual 29 Using the N-560 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. Setting Alarm Silence Duration Discussion WARNING: Do not silence an audible alarm or decrease its volume if patient safety could be compromised. Alarms can be silenced for a preset period called alarm silence duration. To view the current setting, press and hold the Alarm Silence button until 30 SEC, 60 SEC, 120 SEC, or OFF is displayed. To adjust the settings, press and hold the Alarm Silence button until 30 SEC, 60 SEC, 120 SEC, or OFF is displayed. Continue holding the Alarm Silence 30 Using the N-560 button, and use the Adjust Up button or Adjust Down button to increase or decrease the value. Possible values are 30, 60, 90, or 120 seconds, or OFF. The OFF selection is discussed under Disabling Audible Alarms on page 32. If the Alarm Silence button is pressed during the alarm silence duration, the alarm silence duration is ended and the audible alarms are re -enabled. Visual indications of an alarm condition cannot be turned off. For example, if the %SpO2 lower alarm limit is exceeded, the alarm can be silenced for the alarm silence duration, but the %SpO2 value will continue to flash. If the alarm condition is still present when the alarm silence duration has elapsed, the alarm will sound. The power-on default setting for audible alarm silence duration is set at the factory to 60 seconds. The default setting can be adjusted by service personnel as described in the N-560 service manual. 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. N-560 Operator’s Manual 31 Using the N-560 2. While pressing the Alarm Silence button, press and hold the Adjust Up button to increase alarm silence duration to Off, 30, 60, 90, or 120 seconds. 3. While pressing the Alarm Silence button, press and hold the Adjust Down button to decrease alarm silence duration to OFF, 30, 60, 90, or 120 seconds. Note: Releasing the Adjust Up or Adjust Down button sets the alarm silence duration. Disabling Audible Alarms Discussion Setting the alarm silence duration to OFF means that the 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. Procedure With the N-560 in the normal monitoring mode: 32 Using the N-560 1. Press the Alarm Silence button until XX SEC is displayed. 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. N-560 Operator’s Manual 33 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. 34 Using the N-560 5. Press the SatSeconds Alarm Limit button to view the current SatSeconds setting. 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. The decimal point remains on the display until the N-560 is turned off or the limit is returned to the default value. N-560 Operator’s Manual 35 Using the N-560 Alarm limits that have been changed from the default setting are identified by a decimal point (.) after the displayed reading (%SpO2 or Pulse Rate). Setting Alarm Limits Discussion Alarm limits determine the upper and lower points of patient data at which the N-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 (.) after the changed parameter. 36 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. N-560 Operator’s Manual 37 Using the N-560 7. Press the Pulse Rate Alarm Limit button twice to view the current lower alarm limit for Pulse Rate. 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 92 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. 38 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. Simultaneously, press the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for 3 seconds. Menu option 1 will be displayed. N-560 Operator’s Manual 39 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: 24 (2,400 bps) 96 (9,600 bps) 192 default (19,200 bps). 40 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. N-560 Operator’s Manual 41 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. Press the Adjust Up button to select Option 2. 42 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 Operator’s Manual 43 Using the N-560 44 N-560 Trend N-560 Tre n d 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. Note: Trend memory always contains the most recent 24 hours of data, with newly collected data overwriting the oldest data on a rolling basis. The N-560 continues to record data points as long as the N-560 is powered on and an initial patient measurement has been made, with “blank” data points collected if no sensor is connected to the N-560 or patient. “Blank” data will overwrite older patient data if the memory becomes full. Therefore, if you want to save old patient data, it is important that you turn your N-560 off when you are not monitoring a patient, and that you download the trend memory before it fills up and overwrites the old data with new data (or “blank” data). N-560 Operator’s Manual 45 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. The output may be viewed on a PC using the Hyper Terminal program. You must press the SatSeconds Alarm Limit button to initiate printing. Refer to Trend Data Printout on page 61. #2: Trend Clear Clears the existing trend data. To activate, press the SatSeconds Alarm Limit button. #3: Not Used 46 N-560 Trend #4: Baud Rate Allows the interconnection to various printers. Refer to Setting the Data Port Baud Rate on page 39. 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 Operator’s Manual 47 N-560 Trend 48 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. All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements. Anyone who connects a printer or PC to the data output port configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC Standard 60601-1-1 and the electromagnetic compatibility system standard IEC Standard 60601-1-2. Connecting to the Data Port The N -560 data port may be connected to the printer or PC by using a cable terminated with an AMP connector (AMP part number 747538-1), ferrule (AMP part number 1-747579-2), and compatible pins (AMP part number 66570-2). The cable should be no more than 25 feet (7.6 meters) in length. The external ITE (Information Technology Equipment) device must be certified to UL-1950 or IEC-60950. N-560 Operator’s Manual 49 Using the Data Port The cable used must have a braided shield providing 100% coverage, such as a Belden cable (Belden part number 9609) or equivalent. The shield must have a 360-degree connection to the metal shell on the N-560's DB-15 connector and to the connector on the PC or serial printer. Do not create sharp bends in the cable, as this may tear or break the shielding. No hardware flow control is used. However, in the ASCII mode, XON/ XOFF flow control is supported. Data Port Pinouts TXD represents the Transmit Data line, and RXD is the Receive Data line. The pinouts for the data port are listed in Table 1. Table 1: Data Port Pinouts Pin Signal Name 1 RXD+ (RS-422 positive input) 2 RXD (RS-232 input) 3 TXD (RS-232 output) 4 TXD+ (RS-422 positive output)) 5 Signal Ground (isolated from Earth Ground) 6 NC (No connection) 7 Normally Open (relay closure nurse call, normally open) 8 Normally Closed (relay closure nurse call, normally closed) 9 RXD- (RS-422 negative output) 10 Signal Ground (isolated from earth ground) 11 Nurse Call (RS-232 level output) 50 Using the Data Port Table 1: Data Port Pinouts (Cont.) Pin Signal Name 12 TXD- (RS-422 negative output) 13 NC 14 NC 15 Nurse Call Common The pin layouts (as viewed from the rear panel of the N -560) are illustrated in Figure 3. The conductive shell is connected to earth ground when connected to a PC or printer. Figure 3: Data Port Pin Layout Pins 2, 3, 5, and 11 provide data in RS-232 format. Pins 1, 4, 9, and 12 provide data in RS-422 format. TXD+ and TXD- are the differential transmit data pair. RXD+ and RXD- are the differential receive pair. Data Port Setup Discussion Use the Data Port Setup procedure to configure the N-560 data port baud rate and protocol. N-560 Operator’s Manual 51 Using the Data Port Procedure With the N-560 in the normal operating mode: 1. Simultaneously press and hold the SpO2 Alarm Limit button and Pulse Rate Alarm Limit button for at least 3 seconds. Option 1 will be displayed. 2. Press the Adjust Up button until Option 4 is displayed. 3. Press the SatSeconds Alarm Limit Button to select Option 4. The selected baud rate will be displayed. 52 Using the Data Port 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. 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. N-560 Operator’s Manual 53 Using the Data Port 7. Press the Adjust Up button until Option 5 is displayed. 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. 54 Using the Data Port 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. 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. Caution: The nurse call function needs to be tested after it has been set up in your facility. The nurse call feature should be tested whenever setting up the N-560 pulse oximeter in a location that uses nurse call. If an attached OXIMAX sensor is disconnected from the patient, the N-560 remains in the Pulse Search Mode for awhile, then the N-560 displays “--- “ (3 dashes) in the %SpO2 and pulse rate display. One way to test the nurse call function is to create an alarm condition (for example, sensor disconnect) and verify that your facility's nurse call system is activated. N-560 Operator’s Manual 55 Using the Data Port The nurse call feature of the N-560 is operational when the N-560 is powered by AC power or battery power. The nurse call feature of the N-560 works in conjunction with the nurse call system of your institution when the N-560 sounds an audible alarm. The N-560 provides two different types of nurse call interfaces: an RS-232 format and relay closure. Both interfaces function when the N-560 is operating either on AC power or battery power. The remote location is signaled anytime there is an audible alarm. If the audible alarm has been turned off or silenced, the nurse call function is also turned off. Pin 11 on the data port is the RS-232 level nurse call signal and pin 5 or 10 is ground (see Table 1 on page 50). 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. Pins 7 and 15 provide a relay that closes when an alarm is sounding on the N-560. Pins 8 and 15 provide a relay that opens when an alarm is sounding. Pin 15 is a common lead for both relays. Note: When the relay is closed there is approximately 27 ohms of resistance. Setting Nurse Call RS-232 Polarity The nurse call polarity can be set to a high signal on an N-560 alarm condition or a low signal on an N-560 alarm condition. Refer to the N-560 service manual for setting the Nurse Call RS-232 polarity. Setting Nurse Call Relays Normally Open/Closed Data port pins 7 and 15 provide a relay that closes (nominally 27 ohms) when an alarm is sounding on the N-560. Pins 8 and 15 provide a relay 56 Using the Data Port that opens when an alarm is sounding. Pin 15 is a common lead for both relays. The relay operates whether the N-560 is operating on AC power or battery. N-560 Operator’s Manual 57 Using the Data Port 58 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. Note: If the data output stops transmitting, the N -560 must be turned off and then turned back on. When connecting the N-560 to a printer or computer, verify proper operation before clinical use. Both the N -560 and the printer or PC must be connected to a grounded AC outlet. Any printer or computer connected to the N-560's data port must be certified according to IEC Standard 60950. All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements. Anyone who connects a printer or PC to the data output port configures a medical system and is therefore responsible that the system complies with the requirements of system standard IEC Standard 60601-1-1 and the electromagnetic compatibility system standard IEC Standard 60601-1-2. N-560 Operator’s Manual 59 Printing 1 — Data Port Connector 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. 60 Printing Figure 4: Real-Time Data Printout Trend Data Printout The format of data displayed when a trend printout is requested is the same as the real-time data. The only differences are that “TREND” is displayed in the top row instead of the “CRC: XXXX” software verification number and there is no “Status” column. Readings are displayed in 4-second intervals. The values on each row are an average for the 4-second period. At the end of the printout, an “Output Complete” line indicates that the transmission was successful. If the “Output Complete” line is not present, a corruption of the data may have been detected and the data should be ignored. N-560 Operator’s Manual 61 Printing Figure 5: Trend Data Printout Once a trend printout has begun, the N-560 must be turned off and back on again before a new trend printout can begin. Column Headings Column headings are displayed or printed after every 25 lines, or if one of the values in the column heading changes. 62 Printing 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. The numbers may change if the N-560 is serviced and receives a software upgrade. Alarm Limits 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 Operator’s Manual 63 Printing N-560 Mode The N-560 mode is ADULT. Data Column Headings Actual column headings are in the third row of the column heading line. Patient data that is presented in the chart, from left to right, are the time that the patient data on the row was obtained, the current %SpO2 value being measured, the current Pulse Rate in beats per minute (bpm), the current Pulse Amplitude (PA), and the operating status of the N -560. Time 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. 64 Printing 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. PA represents pulse amplitude. The number can range from 0 to 254. There are no alarm parameters for this value. It can be used for trending information as an indication of a change in pulse volume, relative pulse strength, or circulation. Operating Status The Status column indicates alarm conditions and operating status of the N-560. In this example, Pulse High (PH) means that the pulse rate upper alarm limit has been exceeded. The status codes are listed below. As many as four codes can be displayed at one time in the Status column. Code Meaning AO Alarm Off N-560 Operator’s Manual 65 Printing Code Meaning (Cont.) 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. 66 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. WARNING: Use only one pulse oximetry cable to increase the length of the sensor. Use of more than one pulse oximetry cable may have an adverse effect on performance. Do not attach any cable that is intended for computer use to the sensor port. WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. WARNING: Tissue damage can be caused by incorrect application or duration of use of an SpO2 sensor. Inspect the sensor site as directed in the sensor directions for use. N-560 Operator’s Manual 67 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.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html Follow the sensor sterilization procedures in the applicable sensor directions for use (DFU). Table 2: Nellcor Oximetry Sensor Models and Patient Weights OXIMAX Patient Size Sensor Model >=greater than 10 kg (>22 lbs) sensor, single-patient-use OXIMAX Softcare nonadhesive sensor, SC-PR 88 lbs) single-patient-use, adult OXIMAX adhesive sensor, single-patient- MAX-A >30 kg (>66 lbs) use, adult OXIMAX adhesive sensor, single-patient- MAX-AL >30 kg (>66 lbs) use, adult, longer cable 36 inches (91.44 cm) OXIMAX adhesive sensor, single-patient- MAX-N 40 kg use, neonatal/adult (88 lbs) OXIMAX adhesive sensor, single-patient- MAX-P 10 to 50 kg use, pediatric (22 to 110 lbs) 68 Sensors and Accessories Table 2: Nellcor Oximetry Sensor Models and Patient Weights (Cont.) OXIMAX Patient Size Sensor Model >=greater than 50 kg (>110 lbs) use, adult nasal OXIMAX OxiCliq nonadhesive sensor, ® OxiCliq A >30 kg (>66 lbs) single-patient-use, adult, reusable cable OXIMAX OxiCliq nonadhesive sensor, OxiCliq N 40 kg single-patient-use, neonatal/adult, (88 lbs) reusable cable OXIMAX OxiCliq nonadhesive sensor, OxiCliq P 10 to 50 kg single-patient-use, pediatric, reusable (22 to 110 lbs) cable OXIMAX OxiCliq nonadhesive sensor, OxiCliq I 3 to 20 kg single-patient-use, infant, reusable cable (6.6 to 44 lbs) OXIMAX Durasensor finger-clip sensor, ® DS-100A >40 kg (>88 lbs) reusable, adult OXIMAX Oxiband sensor, reusable, ® OXI-A/N 40 kg neonatal/adult (88 lbs) OXIMAX Oxiband sensor, reusable, OXI-P/I 3 kg to 40 kg pediatric/infant (6.6 lbs to 88 lbs) OXIMAX Dura-Y multisite sensor, ® D-YS >1 kg (>2.2 lbs) reusable For use with the Dura-Y sensor: Ear clip (Reusable, nonsterile) D-YSE >30 kg (>66 lbs) Pedi-CheckTM pediatric spot -check 3 kg to 40 kg

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