Nellcor OxiMax N-65 Operator's Manual
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Nellcor OxiMax N-65 Operator's Manual

Hendheld pulse oximeter
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  • Page 2 Services Department, or your local representative. Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett. Covered by one or more of the following U.S. Patents and foreign equivalents: 4,802,486;...

  • Page 3: Table Of Contents

    Warnings ................... 1 Cautions .................... 4 Notes ....................5 Introduction ................. 7 Intended Use for the OXIMAX N-65 ..........7 How to Use this Manual ..............7 Symbols, Controls, Displays, and Indicators ......9 Front Panel Description ..............9 Front Panel Symbols ............... 13 Rear Panel Symbols ...............
  • Page 4 Backlight On/Off ................43 Adjust Pulse Beep Volume ............. 43 Discussion ................43 Procedure — During Monitoring ..........44 Procedure — Using Menu Structure ......... 45 Adjust Alarm Volume ..............46 Discussion ................46 Procedure ................. 46 Set Time and Date ................48 Discussion ................
  • Page 5 Thermal Paper ................83 DEC-4 Extension Cable ............84 Transport Boot ................85 Performance Considerations ........... 87 Performance Verification ..............87 OXIMAX N-65 Performance Considerations ........87 Dysfunctional Hemoglobins ............88 Anemia ..................88 Saturation ................. 88 Pulse Rates ................88 OXIMAX Sensor Performance Considerations .......
  • Page 6 Electrical ..................126 Environmental Conditions ............. 128 Physical Characteristics ..............129 Compliance ................... 129 Manufacturer’s Declaration ............130 Index ..................137 N-65 Operator’s Manual...

  • Page 7: Safety Information

    S a f e t y I n f o r m a t i o n Warnings Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes, such as death, injury, or adverse events to the patient or user.
  • Page 8 Safety Information WARNING: Routinely monitor the patient to make sure the O N-65 is functioning and the sensor is correctly placed. WARNING: Pulse oximetry measurements and pulse signals can be affected by certain environmental conditions, O sensor application errors, and certain patient conditions.
  • Page 9 To avoid shock, the caregiver should not hold the N-65 while using a defibrillator on a patient. WARNING: Disconnect the O N-65 and Nellcor sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns.

  • Page 10: Cautions

    Safety Information WARNING: Do not lift the O N-65 by the sensor or extension cable because the cable could disconnect from the monitor and the monitor may drop on the patient. Cautions Cautions are identified by the CAUTION symbol shown above.

  • Page 11: Notes

    Safety Information Notes Notes are identified by the Note symbol shown above. Notes contain important information that may otherwise be overlooked or missed. Max N-65 Operator’s Manual...
  • Page 12 Safety Information Max N-65 Operator’s Manual...

  • Page 13: Introduction

    I n t r o d u c t i o n WARNING: Do not make any clinical judgments based solely on the O N-65. The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
  • Page 14 Introduction Max N-65 Operator’s Manual...

  • Page 15: Symbols, Controls, Displays, And Indicators

    S y m b o l s , C o n t r o l s , D i s p l a y s , a n d I n d i c a t o r s Front Panel Description This section identifies the symbols, controls, displays, and indicators on the O N-65.
  • Page 16 Symbols, Controls, Displays, and Indicators 5 — %SpO Lower Alarm Limit indicator 6 — %SpO Upper Alarm Limit indicator 7 — Pulse Amplitude indicator (Blip bar) 8 — Time Colon time/date field separator 9 — Adjust Time mode indicator 10 — Adjust Volume mode indicator 11 —...
  • Page 17 Symbols, Controls, Displays, and Indicators 17 — Low Battery indicator 18 — Data In-Sensor indicator 19 — Alarm Volume Adjust indicator 20 — Pulse Beep Tone Volume Adjust indicator 21 — BPM Lower Alarm Limit indicator 22 — Print indicator 23 —...
  • Page 18 Symbols, Controls, Displays, and Indicators 27 — Power button 28 — Up Arrow button 29 — Backlight button 30 — Menu button 31 — Data (Record/Print) button 32 — Down Arrow button 33 — Alarm Silence button Max N-65 Operator’s Manual...

  • Page 19: Front Panel Symbols

    Symbols, Controls, Displays, and Indicators Front Panel Symbols The following two symbols are located on the front panel of the monitor. Displays the measured percent of oxygen saturation. Displays the measured pulse beats per minute. Max N-65 Operator’s Manual...

  • Page 20: Rear Panel Symbols

    Symbols, Controls, Displays, and Indicators Rear Panel Symbols The following symbols are located on the rear panel of the monitor. 1 — Label 2 — Battery Cover See Instructions for Use Type BF Applied Part - Not defibrillator proof Resistant to liquid ingress Rx Prescription only Date of Manufacture European union approval...

  • Page 21: Label Symbols

    Symbols, Controls, Displays, and Indicators Canadian/USA certification mark (electrical safety) Russian regulatory approval Serial number Label Symbols These symbols display on the monitor’s labels. Keep away from heat Temperature limitation Protect from moisture Fragile Keep upright Humidity limitation Max N-65 Operator’s Manual...

  • Page 22: Controls

    Symbols, Controls, Displays, and Indicators Controls This section describes the controls on the front panel of the monitor. The controls are activated by pressing the button that corresponds to that control. For example, press the Alarm Silence button to control the audible alarm.
  • Page 23 Symbols, Controls, Displays, and Indicators Press and hold the Alarm Silence button for three seconds to display the Alarm Silence Duration menu, which allows you to adjust the alarm silence interval from 30, 60, 90, or 120 seconds, or to OFF (alarms disabled).
  • Page 24 Symbols, Controls, Displays, and Indicators Alarms and alarm icons are enabled when parameters are set and display in the event of an alarm condition. Examples of alarms and alarm icons are: • Sensor Disconnected • Pulse Search • Interference • Low Battery •...

  • Page 25: Displays And Indicators

    Symbols, Controls, Displays, and Indicators Note: Normal operation means: • the monitor is turned on • a sensor is connected to the monitor • the sensor is applied to the patient • the patient’s %SpO (oxygen saturation percentage) and pulse rate readings (BM) are being reported •...
  • Page 26 Symbols, Controls, Displays, and Indicators Decimal points after the %SpO or pulse rate indicate that the respective limits have been changed from the power-on default values. There are various matrices within the signal processing algorithm. Some of these are used to assess the severity of conditions presented to the monitor in SpO and pulse rate measurements on a patient.
  • Page 27 Symbols, Controls, Displays, and Indicators Selected display elements, such as, icons or numerals, may flash. There are three flash rates. See Table 1. Table 1: Flash Rates Priority Hertz Duty Cycle High 1.4 Hz to 2.8 Hz 20% to 60% Medium 0.4 Hz to 0.8 Hz 20% to 60%...
  • Page 28 Symbols, Controls, Displays, and Indicators Pulse Rate display: • shows the pulse rate in beats per minute • flashes throughout loss-of-pulse alarms and when the pulse rate is outside of the alarm limits • shows two dashes throughout Sensor Disconnected and Sensor Off Patient conditions •...
  • Page 29 Symbols, Controls, Displays, and Indicators Pulse Search indicator. Displays before initial acquisition of a pulse signal and throughout prolonged challenging monitoring conditions. The Indicator flashes throughout a loss-of-pulse signal. Data In-Sensor indicator. Displays when the sensor contains patient alarm events. The indicator flashes when the sensor memory is full.

  • Page 30: Audible Indicators

    Symbols, Controls, Displays, and Indicators Set Limit mode indicator. Displays when the monitor alarm limit values, or pulse rate values, are being adjusted. Adjust Volume mode indicator. Displays when the monitor alarm volume levels are being adjusted. Sensor Off Patient indicator. Displays when the monitor detects the sensor has come off the patient.
  • Page 31 Failure to do so could result in an inaudible alarm tone. WARNING: Disconnect the O N-65 and Nellcor sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns.

  • Page 32: Set Up The Oximax N-65

    WARNING: Use only the Nellcor extension cable DEC-4 with the O N-65. Do not attach any cable that is intended for computer use to the O sensor port.

  • Page 33: List Of Components

    Set up the OXIMAX N-65 List of Components Quantity Item N-65 handheld pulse oximeter Alkaline “AA” size, 1.5-volt batteries Nellcor O sensor or sensor assortment pack Compact disk (O N-65 manuals) and/or operator’s manual (applicable to country of sale) Quick guide adhesive label...

  • Page 34: Inaccurate Monitor Measurements

    Set up the OXIMAX N-65 Connect a Nellcor O sensor to the monitor sensor port. You may use an extension cable to provide more distance between the monitor and the sensor. Use only the DEC-4 extension cable available from Nellcor.
  • Page 35 Set up the OXIMAX N-65 • failure to cover the O sensor site with opaque material in high ambient light conditions • venous pulsation • dysfunctional hemoglobin • low perfusion Loss-of-pulse signal can occur for the following reasons: • the O sensor is applied too tightly •...
  • Page 36 Set up the OXIMAX N-65 Max N-65 Operator’s Manual...

  • Page 37: Battery Operation

    B a t t e r y O p e r a t i o n WARNING: Dispose of battery in accordance with local ordinances and regulations. Battery Power The O N-65 uses batteries to power the monitor. A new set of batteries provides between 15 to 40 hours of operation depending on the battery type.

  • Page 38: Critical Battery Indication

    Battery Operation Caution: 15 minute indicator for remaining battery operating time is approximate and is based on Alkaline AA batteries. Remaining operating time may be different for other types of batteries. Caution: Periodically check the battery for corrosion. If the O N-65 is to be stored for three months or longer, remove the batteries from the monitor before storage.

  • Page 39: Battery Installation

    Battery Operation Battery Installation To install batteries: 1. Turn off the power. 2. Pull the battery compartment latch downward toward the bottom of the monitor, and remove the battery access door. 3. Install four AA size batteries as shown in Figure 1. Max N-65 Operator’s Manual...
  • Page 40 Battery Operation 4. Replace the battery access door. Battery compartment latch 1 — Figure 1: Battery Installation WARNING: Explosion hazard. Do not use the N-65 in the presence of flammable anesthetics mixed with air, oxygen, or nitrous oxide. WARNING: Dispose of batteries in accordance with local ordinances and regulations.

  • Page 41: Oximax N-65 Operation

    N - 6 5 O p e r a t i o n Introduction The parameters of the O N-65 are set at the factory according to Table 2. The parameters may be set on an individual basis by the clinician. Note: This section contains detailed information on setting parameters.

  • Page 42: Turn On The Oximax N-65

    OXIMAX N-65 Operation Table 2: Parameter Ranges and Defaults (Continued) Ranges/ Factory Parameter Selections Defaults Alarm Silence Alarms 30, 60, 30 seconds Duration 90, 120 seconds, Alarm Volume 1 to 10 Pulse Beep 0 to 10 Volume Turn On the O...

  • Page 43: Procedure

    OXIMAX N-65 Operation When the monitor is turned on, the backlight remains on and the display cycles through the following sequence as POST takes place: • All display graphics are shown for three seconds and the backlight is turned on.
  • Page 44 OXIMAX N-65 Operation All display numbers and icons show for three seconds. The backlight is on while all numbers and icons are shown. 2. The display goes blank for one second. Max N-65 Operator’s Manual...
  • Page 45 OXIMAX N-65 Operation 3. The software version number appears for 3 seconds as a three digit number in the right number field and two dashes in the left number field. Note: The software version 001 is an example. Check the monitor for the software version installed.
  • Page 46 OXIMAX N-65 Operation 5. If the monitor detects a problem, an error tone sounds and an error code (Er) and the error number displays. See Troubleshooting on page 93. 6. Upon successful completion of POST, the monitor sounds a one-second tone to indicate it has passed the test.

  • Page 47: Oximax Sensor Attached

    OXIMAX N-65 Operation Sensor Attached When an O sensor contains patient event alarm data, and is attached to the monitor, the Data In-Sensor indicator is shown. The monitor shows two dashes in the %SpO and Pulse Rate displays as it searches for a valid pulse. For optimal performance allow the monitor to search and lock onto a pulse for approximately 10 seconds.

  • Page 48: No Oximax Sensor Attached

    OXIMAX N-65 Operation When an O sensor is attached to the monitor and applied to a patient, and loses the pulse signal, the monitor displays [- - / - -] (two dashes and two dashes) and displays the Pulse Search icon as shown on the monitor.

  • Page 49: Backlight On/Off

    OXIMAX N-65 Operation The monitor displays [- - / - -] (two dashes and two dashes) and the Pulse Search indicator does not display when the monitor fails to detect an O sensor or an invalid sensor. Backlight On/Off The backlight turns off after approximately 10 seconds.

  • Page 50: Procedure - During Monitoring

    OXIMAX N-65 Operation Procedure — During Monitoring To change the pulse beep volume during monitoring: Press the Up Arrow or Down Arrow button while monitoring to increase or decrease the pulse beep volume. The Pulse Amplitude (blip bar) increments or decrements as a relative indicator of the current volume.

  • Page 51: Procedure - Using Menu Structure

    OXIMAX N-65 Operation Procedure — Using Menu Structure Note: For quick reference information on using the menu structure to set parameters, see Set Menu Parameters on page 108. To adjust the pulse beep volume using the menu structure: 1. From the main monitoring screen, press the Menu button five times until the pulse beep volume level is shown and the monitor sounds.

  • Page 52: Adjust Alarm Volume

    OXIMAX N-65 Operation Adjust Alarm Volume Discussion When the Alarm Volume display shows, adjust the alarm volume by pressing the Up Arrow or Down Arrow button. The Pulse Amplitude (blip bar) increments or decrements as a relative indicator of the current alarm volume.
  • Page 53 OXIMAX N-65 Operation 1. From the main monitor screen, press the Menu button six times until the alarm volume screen appears. 2. Press the Up Arrow or Down Arrow button to increase or decrease alarm volume. 3. Press the Menu button two times to set the alarm level and return to the monitor display screen.

  • Page 54: Set Time And Date

    OXIMAX N-65 Operation Set Time and Date Discussion WARNING: The O sensor uses the date and time provided by the O N-65 when the patient alarm events are recorded to the memory chip in the sensor. The accuracy of the date/time used for patient alarm events depends on the date/time already set in, and provided by the monitor.

  • Page 55: Procedure

    OXIMAX N-65 Operation • 29 February on a non-leap year Procedure To set the time and date: 1. From the main monitor screen, press the Power button to turn the monitor off. 2. Press the Power button to turn the monitor on.
  • Page 56 OXIMAX N-65 Operation 5. Press the Menu button to set the hours and show the minutes set display. The minutes display (45) flashes. 6. Press the Up Arrow button or the Down Arrow button until the desired minutes appear. 7. Press the Menu button to set the minutes and show the day set display.
  • Page 57 OXIMAX N-65 Operation 8. Press the Up Arrow button or the Down Arrow button until the desired day is shown. 9. Press the Menu button to set the day and show the month set display. The month (7) flashes. 10. Press the Up Arrow button or the Down Arrow button until the desired month is shown.
  • Page 58 OXIMAX N-65 Operation 11. Press the Menu button to set the month and display the year set display. The year (2004) will flash. 12. Press the Up Arrow button or the Down Arrow button until the desired year is shown.

  • Page 59: Set Alarm Silence Duration

    OXIMAX N-65 Operation Set Alarm Silence Duration Discussion When the Alarm Silence Duration display shows, you can adjust the alarm silence duration of the high, medium, and low-priority alarms. A low battery low-priority alarm cannot be silenced. Note: When the monitor times-out in 30 seconds, the parameter is set and the monitor returns to the normal mode.

  • Page 60: Disable Audible Alarms

    OXIMAX N-65 Operation Available alarm silence durations are OFF (alarm disabled), 30, 60, 90, and 120 seconds. 2. Press the Up Arrow button or the Down Arrow button until the desired alarm silence duration is shown. 3. Press the Alarm Silence button to set the shown alarm silence duration and return to normal operation.

  • Page 61: Procedure

    OXIMAX N-65 Operation Note: When the monitor times-out in 30 seconds, the parameter is set and the monitor display returns to the normal mode. Procedure To disable audible alarms: WARNING: Do not silence the audible alarm function, or decrease the audible alarm volume, if patient safety could be compromised.

  • Page 62: Set Alarm Limits

    OXIMAX N-65 Operation 2. Press the Alarm Silence button to set the alarm silence duration to OFF and return to normal operation. The Alarm Silence indicator flashes and an audible reminder sounds every three minutes while the alarm silence duration is set to OFF.

  • Page 63: Procedure

    OXIMAX N-65 Operation Procedure To set alarm limits: 1. From the main monitor screen, press the Menu button once. The SpO lower alarm limit displays. The %SpO low alarm limit range is 20% to 99%. The upper value of the %SpO...
  • Page 64 OXIMAX N-65 Operation The %SpO upper alarm limit range is 21% to 100%. The lower value of the %SpO upper alarm limit is limited to the %SpO low alarm limit. The %SpO upper alarm limit cannot be set equal to or lower than the %SpO low alarm limit.
  • Page 65 OXIMAX N-65 Operation 6. Press the Up Arrow or Down Arrow buttons to increase or decrease the lower limit. 7. Press the Menu button to set the limit value. The BPM upper alarm limit displays. The pulse rate upper alarm limit range is 31 to 250.
  • Page 66 OXIMAX N-65 Operation 8. Press the Up Arrow or Down Arrow button to increase or decrease the upper pulse rate limit. 9. Press the Menu button to confirm the alarm limit settings. 10. Press the Menu button until you return to normal operation.

  • Page 67: Alarm Limit Changed Indicator

    OXIMAX N-65 Operation Alarm Limit Changed Indicator Alarm limits that have changed from the default values are identified by a decimal point (.) after the shown value (%SpO or BPM). The Alarm Limit Changed indicator displays anytime an alarm limit changes.

  • Page 68: Procedure

    OXIMAX N-65 Operation Procedure To record data: 1. From the main monitor screen, press the Data button to capture a record of the patient data (snap shot). The captured data displays. The number (1) in the SpO field is the identification (ID) number of captured snap-shots.

  • Page 69: Print Data

    OXIMAX N-65 Operation Print Data Discussion The monitor can print data when used with a Citizen PD- 22T portable printer, which is available from Nellcor Customer Services at 1.800.635.5267, or your local Nellcor representative. Caution: Ensure that the printer model number contains a “T,”...
  • Page 70 OXIMAX N-65 Operation • sensor event data (patient alarm event data), if a sensor with patient event data is connected to the monitor The monitor prints all available data as shown in Figure 2. Figure 2: Combined Printed Data Max N-65 Operator’s Manual...

  • Page 71: Print Mode

    OXIMAX N-65 Operation Print Mode If you press the Data button in the print menu when no data is stored, and the device is not connected to a patient, an invalid key tone sounds and the monitor transitions to normal mode.
  • Page 72 OXIMAX N-65 Operation If snap-shot data are stored in the monitor memory, the Data icon shows on the print data display. If sensor-event data are stored in sensor memory, the Data In-Sensor icon shows on the print data display. If both types of data are stored, both icons show.

  • Page 73: Procedure

    OXIMAX N-65 Operation Procedure To print data: 1. Align the printer and the monitor. 2. Orient the printer and monitor as shown in Figure 3. The alignment of the infrared ports of the printer and the monitor must not exceed two feet and must not be closer than six inches (15 cm).
  • Page 74 OXIMAX N-65 Operation 3. From the main monitor screen, press the Menu button seven times. The print display is shown. 4. Press the Data button to start printing. During printing, the stored snap-shot number displays for each snap-shot. Max N-65 Operator’s Manual...

  • Page 75: Oximax Sensor Event Record

    S e n s o r E v e n t R e c o r d Event Records WARNING: The O sensor uses the date and time provided by the O N-65 when the sensor event record is recorded by the sensor. The accuracy of the date/time is dependent on the date/time already set in and provided by the monitor.
  • Page 76 OXIMAX Sensor Event Record Event records can be viewed only after an O sensor containing patient alarm events has been connected to an monitor capable of displaying sensor event records. The O N-65 does not support viewing sensor event records, but does support printing sensor event records.

  • Page 77: Oximax Sensors And Accessories

    WARNING: Do not use a damaged O sensor or extension cable. Do not use an O sensor with exposed optical components. WARNING: Use only Nellcor-approved O sensors and extension cables with the O N-65. Other sensors or extension cables may cause improper monitor performance.
  • Page 78 OXIMAX Sensors and Accessories WARNING: Do not attach any cable to the O sensor port connector that is intended for computer use. WARNING: Tissue damage can be caused by incorrect application or duration of use of an O sensor. Inspect the O sensor site periodically as directed in the O sensor Directions For Use.
  • Page 79 OXIMAX Sensors and Accessories Caution: The O Sensor Disconnected icon and associated alarm indicate that either the O sensor is disconnected or the wiring is faulty. Check the O sensor connection and, if necessary, replace the O sensor, extension cable, or both. For additional information on monitor measurements, see Inaccurate Monitor Measurements on page 28.
  • Page 80 For additional information refer to Table 3 or contact your local Nellcor Representative. Refer to OXIMAX Sensor Performance Considerations on page 89 for additional information on O sensor performance. Table 3: Nellcor Oximetry Sensor Models and Patient Weights Patient Size Sensor Model >...
  • Page 81 OXIMAX Sensors and Accessories Table 3: Nellcor Oximetry Sensor Models and Patient Weights (Continued) Patient Size Sensor Model > = greater than < = less than adhesive sensor, MAX-R >50 kg (110 lbs) single-patient use, adult nasal OxiCliq A >30 kg (66 lbs) ®...

  • Page 82: Oximax Sensor Features

    OXIMAX Sensors and Accessories Table 3: Nellcor Oximetry Sensor Models and Patient Weights (Continued) Patient Size Sensor Model > = greater than < = less than ® D-YS >1 kg (>2.2 lbs) Dura-Y multisite sensor, reusable For use with the Dura-Y...

  • Page 83: Biocompatibility Test

    OXIMAX Sensors and Accessories Biocompatibility Test Biocompatibility testing has been conducted on Nellcor sensors in compliance with ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. The O sensors have passed the recommended biocompatibility testing and are, therefore, in compliance with ISO 10993-1.

  • Page 84: Rubber Boot With Clip

    OXIMAX Sensors and Accessories Rubber Boot With Clip This accessory protects the monitor. 1 — Front view 2 — Rear view Figure 4: Rubber Boot with Clip Max N-65 Operator’s Manual...

  • Page 85: Functional Thermoformed Holster

    OXIMAX Sensors and Accessories Functional Thermoformed Holster This accessory protects the monitor. 1 — Front view 2 — Rear view Figure 5: Functional Thermoformed Holster Max N-65 Operator’s Manual...

  • Page 86: Carrying Case

    OXIMAX Sensors and Accessories Carrying Case The Nylon carrying case is equipped with compartments for: • the monitor • Operator’s manual • compact disk containing all manuals • sensors and, • a carrying strap that is adjustable from 71 cm to 135 cm (28 inches to 53 inches) Figure 6: Carrying Case Max N-65 Operator’s Manual...

  • Page 87: Water-Resistant Jacket

    OXIMAX Sensors and Accessories Water-Resistant Jacket The water-resistant jacket is made of clear plastic to facilitate use of the monitor in inclement weather or similar conditions. Figure 7: Water-Resistant Jacket Max N-65 Operator’s Manual...

  • Page 88: Infrared Printer

    OXIMAX Sensors and Accessories Infrared Printer The Citizen PD-22T portable printer is used to print selected data from the monitor. The monitor uses the printer IrDA infrared interface. Refer to the User’s Manual supplied with the printer for details on the PD-22T printer.

  • Page 89: Thermal Paper

    OXIMAX Sensors and Accessories Thermal Paper The thermal paper is for the Citizen PD-22T infrared printer. Refer to the User’s Manual supplied with the printer for details on the thermal paper. Figure 9: Thermal Paper Max N-65 Operator’s Manual...

  • Page 90: Dec-4 Extension Cable

    OXIMAX Sensors and Accessories DEC-4 Extension Cable The DEC-4 extension cable provides 1.2 m (4 ft.) of cable extension between the monitor and the sensor. 1 — DEC-4 extension cable 2 — Sensor connector Figure 10: DEC-4 Extension Cable Max N-65 Operator’s Manual...

  • Page 91: Transport Boot

    OXIMAX Sensors and Accessories Transport Boot This accessory is used in the transport environment for compliance with ISO 9919 outside of a hospital, such as ambulance transport. 1 — Front view 2 — Rear view Figure 11: Transport Boot Max N-65 Operator’s Manual...
  • Page 92 OXIMAX Sensors and Accessories Max N-65 Operator’s Manual...

  • Page 93: Performance Considerations

    P e r f o r m a n c e C o n s i d e r a t i o n s WARNING: Pulse oximetry readings and pulse signals can be affected by ambient environmental conditions, O sensor application errors, and patient conditions.

  • Page 94: Dysfunctional Hemoglobins

    Performance Considerations Dysfunctional Hemoglobins Dysfunctional hemoglobins, such as, carboxyhemoglobin, methemoglobin, and sulfhemoglobin, are unable to carry oxygen. SpO 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.

  • Page 95: Oximax Sensor Performance Considerations

    O sensor directions for use. WARNING: Use only Nellcor-approved O sensors and extension cables. Do not use cables more than 4 feet in length. Use only the DEC-4 extension cable or only the O sensor.
  • Page 96 Performance Considerations • low perfusion Loss-of-pulse signal can occur for the following reasons: • the O sensor is applied too tightly • defibrillation • a blood pressure cuff is inflated on the same extremity as the one with the O sensor attached •...
  • Page 97 Performance Considerations To prevent interference from ambient light, ensure that the O sensor is properly applied, and cover the sensor site with opaque material. If interference due to patient activity presents a problem, try one or more of the following to correct the problem: •...
  • Page 98 Performance Considerations Max N-65 Operator’s Manual...

  • Page 99: Troubleshooting

    T r o u b l e s h o o t i n g WARNING: If you are uncertain about the accuracy of any measurement, check the patient's vital signs by alternate means; then make sure the O N-65 is functioning correctly.
  • Page 100 Troubleshooting See Table 5, "Error Codes", on page 94 for a list of error codes and corrective actions. When an error occurs, the unit: • stops monitoring • removes all information from the display and displays the message “Er XXX” •...

  • Page 101: Corrective Action

    Corrective Action If you experience a problem while using the monitor and are unable to correct it, contact qualified service personnel or your local Nellcor representative. The N-65 service manual, which is for use by qualified service personnel, provides additional troubleshooting information.
  • Page 102 Install new batteries. See Battery Installation on page 33. 2. One or more display segments or indicators do not light during the power-on-self-test. • Do not use the monitor; contact qualified service personnel or your local Nellcor Representative. Max N-65 Operator’s Manual...
  • Page 103 Troubleshooting 3. The Pulse Search indicator displays for more than 10 seconds. • Check the sensor directions for use to determine if an appropriate sensor is being used and if it is applied properly. Check sensor and extension cable connections. Test the sensor on another subject. Try another sensor or extension cable.
  • Page 104 5. “Er” followed by a number appears on the display. • Disconnect the sensor from the monitor. Restart the monitor. If error code appears again, record the number and provide that information to qualified service personnel or your local Nellcor representative. Max N-65 Operator’s Manual...

  • Page 105: Emi (Electromagnetic Interference)

    Troubleshooting EMI (Electromagnetic Interference) Caution: This device has been tested and found to comply with the limits for medical devices to the EN60601-1-2, (second edition), and the Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

  • Page 106: Technical Assistance

    Technical Assistance For technical information and assistance, or to order parts or a service manual, contact Nellcor’s Technical Service Department at: 1.800.635.5267 Or call your local Nellcor representative. The service manual includes block diagrams and a parts list required by qualified personnel when servicing the O N-65.
  • Page 107 Troubleshooting The software version appears in the monitor display each time the it successfully completes the power-on self-test. Write the number down so it is available when you request technical assistance. This manual and the O N-65 Service Manual are available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html Max N-65 Operator’s Manual...
  • Page 108 Troubleshooting Max N-65 Operator’s Manual...

  • Page 109: Maintenance

    Caution: The O N-65 will not operate with dead batteries. Install new batteries. Return the O N-65 Contact Nellcor’s Technical Service Department at: 1.800.635.5267 for shipping instructions including a Returned Goods Authorization (RGA) number. Unless otherwise instructed by Nellcor’s Technical...

  • Page 110: Service

    N-65. Only qualified service personnel should remove the cover. The monitor requires no calibration. If service is necessary, contact qualified service personnel or your local Nellcor Representative. Periodic Safety Checks It is recommended that the following checks be performed every 24 months: •...

  • Page 111: Cleaning

    Maintenance Cleaning Caution: Do not spray, pour, or spill any liquid on the N-65 its accessories, connectors, switches, or openings in the enclosure as this may damage the monitor. You can surface-clean and disinfect the monitor and the sensor. To surface-clean the monitor: •...
  • Page 112 Maintenance N-65 Operator’s Manual...

  • Page 113: Menu Structure

    M e n u S t r u c t u r e Set Menus Quick Reference This section contains quick reference information on how to set monitor parameters and limits using the menu structure. See Set Menu Parameters on page 108 to set the following parameters: •...

  • Page 114: Set Menu Parameters

    Menu Structure Set Menu Parameters To set menu parameters, press the Menu button repeatedly during normal operation to display the parameters to set. Use the Up Arrow button or Down Arrow button to adjust the parameter limit. Press the Menu button to return to the default monitoring display. Table 6: Menu Structure # of Parameter...
  • Page 115 Menu Structure Table 6: Menu Structure (Continued) # of Parameter Press Function Presses Pulse Beep Adjust volume. Indications Volume on blip bar. Alarm Adjust volume. Indications Volume on blip bar. Print Data Print summary and/or stored snap-shot and sensor-event data. N-65 Operator’s Manual...

  • Page 116: Set Time/Date Parameters

    Menu Structure Set Time/Date Parameters To access the Time/Date settings menu, press the Menu button during start-up Power-On-Self-Test (POST). Press the Menu button repeatedly to display the time/date parameters to set. Use the Up Arrow button and Down Arrow button to adjust time/date settings. Press the Menu button to return to the POST display.
  • Page 117 Menu Structure Table 7: Time Set Menu # of Parameter Press Function Presses The Menu button must be pressed during the POST. Hour Adjust 1 to 23 Minute Adjust 1 to 59 Adjust 1 to 31 Month Adjust 1 to 12 Year Adjust 2003 to 2099 N-65 Operator’s Manual...
  • Page 118 Menu Structure N-65 Operator’s Manual...

  • Page 119: Principles Of Operation

    For additional information about ambient conditions, sensor application, and patient conditions, see OXIMAX N-65 Performance Considerations on page 87. Pulse oximetry is based on two principles: • oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry) •...

  • Page 120: Automatic Calibration

    Principles of Operation A pulse oximeter determines SpO by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared low-voltage light-emitting diodes (LED) in the oximetry O sensor serve as light sources;...

  • Page 121: Functional Versus Fractional Saturation

    Principles of Operation Additionally, to compensate for differences in tissue thickness, the light intensity of the O sensor's LEDs is adjusted automatically. Functional versus Fractional Saturation This pulse oximeter measures functional saturation – oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen.
  • Page 122 Principles of Operation Figure 12: Oxyhemoglobin Dissociation Curve Technology The O N-65 is designed to use Nellcor O brand sensors, which integrate the O technology. These O sensors are identified by their deep lavender/blue plug color. All O sensors contain a...

  • Page 123: Oximax Technology

    Many functional testers and patient simulators have been designed to interface with the pulse oximeter’s expected calibration curves and may be suitable for use with Nellcor monitors and/or sensors. Not all such devices, however, are adapted for use with the Nellcor O Max N-65 Operator’s Manual...
  • Page 124 Principles of Operation digital calibration system. While this will not affect use of the simulator for verifying system functionality, displayed SpO measurement values may differ from the setting of the test device. For a properly functioning monitor, this difference will be reproducible over time and from monitor to monitor within the performance specifications of the test device.

  • Page 125: Specifications

    S p e c i f i c a t i o n s Performance Measurement Range 1% to 100% Pulse Rate 20 beats per minute (bpm) to 250 Perfusion Range 0.03% to 20% Accuracy Tolerance Saturation 70 to 100% ±2 digits Adult 70 to 100% ±3 digits Neonate...
  • Page 126 Specifications Accuracy Tolerance (Continued) Adult specifications are shown for O Max MAX-A and MAX-N sensors with the N-65. Neonate specifications are shown for O MAX-N sensors with the N-65. Saturation accuracy will vary by sensor type. Refer to the Sensor Accuracy Grid. The Sensor Accuracy Grid is shipped with the N-65.
  • Page 127 Specifications Audible Indicators Audible Parameter Value Indicator Alarm Volume Volume level Adjustable, 40 to 52 Setting dB(A), at one meter Pitch (±30 Hz) 752 Hz On pulse width 500 msec (±20 msec) Off Interval (±20 msec) 10 msec Number of pulses in burst Repetition Pause (±2 sec.)
  • Page 128 Specifications Audible Indicators (Continued) Audible Parameter Value Indicator POST Pass Volume level Fixed at 45 dB(A), at one meter Pitch (±30 Hz) 600 Hz On pulse width 1000 msec (±20 msec) Off Interval (±20 msec) 10 msec Number of pulses in burst Repetition Pause (±2 sec.)
  • Page 129 Specifications Audible Indicators (Continued) Audible Parameter Value Indicator Confirmation Volume level Fixed at 45 dB(A), at one meter Pitch (±30 Hz) 700 Hz On pulse width 130 msec (±20 msec) Off Interval (±20 msec) 130 msec Number of pulses in burst Repetition Pause (±2 sec.)
  • Page 130 Specifications Audible Indicators (Continued) Audible Parameter Value Indicator Pulse Beep Volume level Adjustable, 42 to 52 dB(A), at one meter Pitch (±30 Hz) 1500 Hz On pulse width 50 msec (±20 msec) Off Interval (±20 msec) 10 msec Number of pulses in burst Repetition Pause (±2 sec.)
  • Page 131 Specifications Audible Indicators (Continued) Audible Parameter Value Indicator High Priority Volume level Adjustable, 42 to 52 Alarm dB(A), at one meter Pitch (±30 Hz) 1200 Hz On pulse width 250 msec (±20 msec) Off Interval (±20 msec) 80 msec Number of pulses in burst Repetition Pause 0 sec.

  • Page 132: Electrical

    Specifications Audible Indicators (Continued) Audible Parameter Value Indicator Low priority Volume level Adjustable, 42 to 52 Alarm dB(A), at one meter Pitch (±30 Hz) 500 Hz On pulse width 400 msec (±20 msec) Off Interval (±20 msec) 3200 msec Number of pulses in burst Repetition Pause 0 sec.
  • Page 133 Specifications Sensors Wavelength Nellcor pulse oximetry sensors contain LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 900 nm. The total optical output power of the sensor LEDs is less than 15 mW.

  • Page 134: Environmental Conditions

    Specifications Sensor Power Dissipation Sensor Dissipation Softcare SC-PR 52.5 mW Softcare SC-NEO 52.5 mW Softcare SC-A 52.5 mW Oxiband OXI-A/N 52.5 mW Environmental Conditions Operation Temperature 5 ºC to 40 ºC (41 ºF to 104 ºF) Altitude 390 m to 3,012 m ( 1,254 ft.

  • Page 135: Physical Characteristics

    Specifications Transport and Storage (in shipping container) Relative Humidity 15% to 95% non condensing Physical Characteristics Weight 0.62 lbs. (0.28 kg) Dimensions 2.875 in. x 6.25 in. x 1.375 in. (7.3 cm x 15.9 cm x 3.5 cm) Compliance Item Compliant With Equipment classification Safety Standards: EN 60601-1: 1990...

  • Page 136: Manufacturer's Declaration

    Specifications Item (Continued) Compliant With (Continued) Pulse oximeters EN 865 and ISO 9919 with Transport Boot (Part number 10007434) Operation during vibration IEC 60068-2-6 and IEC 60068-2-34 Radiated and conducted EN 55011, Group 1, Class B emissions Manufacturer’s Declaration WARNING: The use of accessories, sensors, and cables other than those specified may result in increased emission and/or create invalid readings of the O...
  • Page 137 Specifications Table 8: Recommended Separation Distances Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the O N-65 (IEC 60601 Frequency of 150 kHz to 80 MHz to 800 MHz to Transmitter 80 MHz 800 MHz 2.5 GHz Equation ------ - ------ -...
  • Page 138 Specifications Table 9: Cable Compliance Cables Comply With: • RF emissions, EN 55011, Class B/Group 1 • EN 60601-1-2: 2001 Maximum Cables and O Sensors Length OxiCliq-OC-3 cable 3 ft. (0.9 m) DEC-4 sensor extension cable 4 ft. (1.2 m) MAX-FAST sensor 30 in.
  • Page 139 Specifications Table 10: Electronic Emissions The O N-65 is intended for use in the electromagnetic environment specified below. The customer or user of the monitor should assure that it is used in such an environment. Electromagnetic Emission Test Compliance Environment - Guidance RF emissions Group 1...
  • Page 140 Specifications Table 11: Electromagnetic Immunity The O N-65 is intended for use in the electromagnetic environment specified below. The customer or user of the monitor should assure that it is used in such an environment. Electromagnetic IEC 60601 Compliance Immunity Test Environment Test Level Level...
  • Page 141 Specifications Table 12: Electromagnetic Immunity Electromagnetic IEC 60601 Compliance Immunity Test Environment - Test Level Level Guidance Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications IEC 61000-4-6 150 kHz to equipment should be 80 MHz used no closer to any part of the O Radiated RF 3 V/m...
  • Page 142 Specifications Table 12: Electromagnetic Immunity ------ - 800 MHz to 2.5 GHz Interference may occur in the vicinity of equipment marked with this symbol. Note 1: At 80 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

  • Page 143: Index

    Index I n d e x Symbols %SpO2 high limit 108 %SpO2 low limit 108 accessories 77 accuracy 119 alarm limit changed indicator 61 alarm limit display 56 alarm limits setting 56 alarm silence duration 53 alarm silence indicator 22 alarm volume 109 adjusting 46 anemia 88...
  • Page 144 Index calculated saturation 115 calibration 104 carrying case 80 cautions 4 cleaning 105 connecting an OXIMAX Sensor 27 controls 9, 16 alarm silence 16 backlight 18 data (record/print) 17 down arrow 17, 18 menu 17 power 19 up arrow 18 dashes 43 day 111 DEC-4 extension cable 84...
  • Page 145 Index front panel buttons 9 symbols 9 functional saturation 115 functional thermoformed holster 79 hour 111 how to use this manual 7 indicator alarm silenced 22 interference 22 low battery 22 pulse amplitude 21 indicators 9, 19 infrared printer 82 intended use 7 introduction 7 label symbols 15...
  • Page 146 111 normal monitoring mode 19 notes 5 operating altitude 128 relative humidity 128 temperature 128 optional accessories 77 OXIMAX N-65 measurement range 119 returning 103 OXIMAX technology 116 oximetry overview 113 paper 83 parameter ranges 35 performance considerations pulse oximeter 87...
  • Page 147 70 sensor models and patient weights 74 service 104 alarm limits 56 alarm silence duration 53 date 48 time 48 set up the OXIMAX N-65 25 snap-shot data 61 specifications 119 battery 126 Max N-65 Operator’s Manual...
  • Page 148 Index compliance 129 electrical 126 environmental 128 performance 119 physical 129 storage altitude 128 relative humidity 128 temperature 128 symbols 9 Canadian ICES-001 approval 15 date of manufacture 14 decimal points 20 European union approval 14 fragile 15 front panel 13 keep away from heat 15 keep upright 15 label 15...
  • Page 149 Index temperature 128 troubleshooting 93 help 96 turning on the OXIMAX N-65 36 verification performance 87 volume adjusting alarm 46 pulse beep 43 warning 1 water-resistant jacket 81 wavelength, sensor 127 year 111 Max N-65 Operator’s Manual...
  • Page 152 Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton, CA 94588 U.S.A. Telephone Toll Free 1.800.635.5267 Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS, U.K. © 2006 Nellcor Puritan Bennett Inc. All rights reserved Rx ONLY 10006537B_0106...

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