N-600. Pulse Oximeter Home Use Guide

N-600 Pulse Oximeter Home Use Guide Important: Read this manual before using the monitor If you need help, call the 24-hour hotline of the medical equipment dealer listed below:

Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, Dura-Y, Max-Fast, SoftCare, and OxiMax are trademarks of Nellcor Puritan Bennett Inc. Cet appareil ISM est conforme à la norme NMB-001 Canada. To obtain information about a warranty, if any, contact Nellcor s Customer 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.

Contents Contents............................................... i Figures............................................... iv Tables................................................ v Important Information.................................... 1 Introduction...1 Definitions...1 Clinician:...1 Normal Monitoring Mode:...1 Oxygen Saturation:...2 Pulse Amplitude:...2 Pulse Oximeter:...2 Pulse Rate:...2 Sensor:...3 If You Need Help...3 Safety Information....................................... 5 Warnings...5 Cautions...7 Purpose of the N-600.................................... 9 Purpose of the N-600...9 Role of the Clinician...9 Home Use Guide i

Contents Buttons, Indicators, and Alarms........................... 11 Front Panel Control Buttons... 11 Function of Front Panel Control Buttons... 12 Front Panel Status Indicators and Components... 13 Description of Status Indicators... 14 BLIP Display Information... 16 Description of BLIP Display Information... 16 PLETH Display Information... 18 Description of PLETH View Information... 18 Front Panel Symbol... 19 Rear Panel Components... 20 Rear Panel Symbols... 20 Description of Audible Tones and Alarms... 21 Setting Up the N-600.................................... 23 Connecting the N-600 to AC Power... 25 Oximetry Sensors...................................... 29 Selecting an Oximetry Sensor... 29 ii OxiMax N-600

Contents Using the N-600....................................... 33 Introduction...33 Factory Default Settings...33 Turning On the N-600...35 Connecting a Sensor to the N-600...37 Selecting the BLIP View...40 Setting the Pulse Beep Volume...41 Setting the Alarm Volume...41 Turning the Display Backlight Off or On...41 Adjusting Display Contrast...42 Setting the Date and Time...42 Adult-Pediatric and Neonatal Settings...43 Selecting the Monitoring Mode...44 Setting Alarm Limits...46 Alarm Limit Changed Indicator...48 Sensor Messages...48 Sensor Message Setup...50 Selecting the Display Language...51 Patient Trend Data...52 Nurse Call Feature...52 Prompt and Error Messages.............................. 53 Introduction...53 Managing Prompt and Error Messages...53 Performance Considerations.............................. 57 Sensor Performance Considerations...57 Battery Operation...................................... 61 Operating on Battery Power...61 Automatic Shutdown to Conserve Battery...61 Recharging the Battery...62 Low Battery Indicator...62 Home Use Guide iii

Contents Troubleshooting........................................ 65 Error Codes... 65 Solving Problems... 67 EMI (Electromagnetic Interference)...70 Maintenance.......................................... 73 Service... 73 Periodic Safety Checks... 73 Cleaning... 73 Specifications......................................... 75 Performance... 75 Electrical... 76 Environmental Conditions... 77 Physical Description... 80 Compliance... 80 Index................................................ 81 iv OxiMax N-600

Contents Home Use Guide v

Contents Figures Figure 1: Front Panel Control Buttons... 11 Figure 2: Front Panel Status Indicators and Components... 13 Figure 3: Blip Display Information... 16 Figure 4: Pleth Display Information... 18 Figure 5: Rear Panel Components... 20 Figure 6: Rear Panel Symbols... 21 Figure 7: Voltage Selector and Power Connector... 25 Figure 8: Power Cord Connection... 26 Figure 9: Connecting Sensor and DOC-10 Cable... 38 vi OxiMax N-600

Contents Tables Table 1: Audible Tones and Alarms...21 Table 2: Nellcor Oximetry Sensor Models and Patient Weights...31 Table 3: Parameter Factory Defaults and Ranges... 34 Table 4: Error Message...54 Table 5: Prompt Messages...55 Table 6: Error Codes...66 Home Use Guide vii

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Important Information Introduction This manual is for the home caregiver the person who provides care for a patient monitored by the OxiMax N-600 pulse oximeter in the home. As the home caregiver, it is important that you read this entire manual before you use the N-600. This manual contains important safety information and N-600 instructions. If you do not understand any part of this information, ask the clinician to explain it to you. Definitions Clinician: In this manual, the term clinician means the trained health care professional who assists you with monitoring the patient and using the N-600 in your home. This person can be the doctor or nurse who is treating the patient, or some other trained health care professional. Home Use Guide 1

Important Information Normal Monitoring Mode: Normal monitoring mode means that: the N-600 is turned on, a sensor is connected to the N-600, via the DOC-10 Pulse Oximetry Cable, the sensor is applied to the patient, the patient s %SpO2 (oxygen saturation percentage) and pulse rate readings (BPM) are being reported, and no error conditions exist. Oxygen Saturation: A measurement of the percentage of oxygen circulating in the patient s blood. Oxygen saturation is also identified as %SpO2. Pulse Amplitude: The relative strength of the patient s pulse. A higher pulse amplitude indicates a stronger pulse. A lower pulse amplitude indicates a weaker pulse. Pulse Oximeter: A medical device that measures a patient s pulse rate and oxygen saturation in the blood. The N-600 is a pulse oximeter. 2 OxiMax N-600

Important Information Pulse Rate: A measurement of the number of times the patient s heart beats per minute. Pulse rate is also called beats per minute or BPM. Sensor: A sensor is an accessory used to collect and send patient information to the N-600. One end of the sensor is attached to the patient s finger, toe, ear lobe, or forehead and the other end of the sensor connects to the monitor cable. The sensor provides measurement signals from which the pulse rate and percentage of oxygen in blood are determined. If You Need Help Contact the clinician if you have any questions or concerns about using the N-600. If you believe the N-600 is not functioning properly, always notify the clinician, who may be able to correct the problem. If you require assistance in operating the N-600, and are unable to contact the clinician, call the 24-hour hotline of your medical equipment dealer. Keep the dealer s business card with this manual. That card shows the hotline number. Home Use Guide 3

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Safety Information Warnings Warnings in this manual are identified by the WARNING symbol shown above. Warnings alert you to potential serious outcomes (death, injury, or adverse events) to you or the patient. Contact the clinician if you have any questions regarding the warnings in this manual. WARNING: Explosion hazard. Do not use the N-600 in the presence of flammable anesthetics or gases. WARNING: Chemicals from a broken LCD display panel are toxic when ingested. Use caution when handling a N-600 with a broken display panel. Home Use Guide 5

Safety Information WARNING: Pulse oximetry readings and pulse signals can be affected by certain environmental conditions, oximetry sensor application errors, and certain patient conditions. Refer to the appropriate sections of this manual, including this chapter, for specific safety information. Oximetry Sensors on page 29 Sensor Performance Considerations on page 57 EMI (Electromagnetic Interference) on page 70 WARNING: The use of accessories, oximetry sensors, and cables other than those specified in this manual may result in inaccurate readings of the N-600. WARNING: Do not lift the N-600 by the oximetry cable or power cord because the cable or cord could disconnect from the N-600, causing the N-600 to drop on the patient. WARNING: Make sure that the speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm tone. WARNING: Make sure that you can hear an audible alarm from other rooms in the home, and when you are using noisy appliances, such as a dishwasher, clothes dryer, television, or radio. Failure to ensure that the alarm volume is appropriate for the environment may place the patient in danger. If you need the volume adjusted, immediately contact the clinician for help. 6 OxiMax N-600

Safety Information Cautions Cautions are identified by the CAUTION symbol shown above. Cautions alert you to exercise care necessary for the safe and effective use of the N-600. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Caution: The oximetry sensor disconnect error message and associated alarm indicate that the sensor is either disconnected or the wiring is faulty. Check the sensor connection and, if necessary, replace the sensor, pulse oximetry cable, or both. If necessary, contact the clinician for assistance. Notes are identified by the Note symbol shown above. Notes provide additional useful information. Home Use Guide 7

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Purpose of the N-600 WARNING: The N-600 is only a warning device. You must take action, as directed by the clinician, when an alarm occurs. The N-600 cannot act for you. WARNING: The N-600 and the oximetry sensor are prescription devices. Use only on the patient for whom prescribed and only as directed by the clinician. Purpose of the N-600 The N-600 can be used for patients of all ages infants, children, and adults. The clinician will assist you with the selection and use of the appropriate oximetry sensor, based on the size and/or age of the patient. (See Oximetry Sensors on page 29). The N-600 continuously measures the patient s pulse rate and the percentage of oxygen circulating in the blood. When either the patient s pulse rate or the percentage of oxygen goes below or above a pre-set alarm limit, the N-600 warns you by sounding an alarm, lighting an indicator light, and/or flashing a number. Home Use Guide 9

Purpose of the N-600 Role of the Clinician The clinician is a trained health care professional who will: order a N-600 for use in your home set up the N-600 for you assist you with monitoring the patient review the monitored results and the patient s condition show you how to use the N-600 select a sensor for use with the N-600 show you how to respond to alarms show you how to set the alarm limits answer your questions about the N-600 ensure that the N-600 is working correctly follow up with you on a regular basis to make sure the N-600 is meeting your needs 10 OxiMax N-600

Buttons, Indicators, and Alarms This section introduces you to the control buttons, status indicators, and symbols on the front and rear panels of your N-600. Audible tones and alarms are also described. Familiarize yourself with this section before using the N-600. Front Panel Control Buttons 1 On/Standby Button 6 Contrast Button 2 Alarm Silence Button 6 Softkeys 3 Adjust Up Button 7 Softkey Menu Bar 4 Adjust Down Button Figure 1: Front Panel Control Buttons Home Use Guide 11

Buttons, Indicators, and Alarms Note: A valid button press, except the On/Standby button, should cause the N-600 to sound a valid or an invalid tone. If the button pressed fails to emit a tone, contact the clinician immediately. Function of Front Panel Control Buttons This section identifies and describes the function of each control button located on the front panel. Refer to Figure 1 on page 11 for the location of each button. The On/Standby button is used to turn the N-600 on or off. The Alarm Silence button is used to silence current audible alarms for the alarm silence duration period, which is typically one minute. If an audible alarm condition still exists after the alarm silence duration had timed out, the alarm will sound again.when an alarm has been silenced, pressing the button again reactivates, or unsilences the alarm. Use the Alarm Silence button to clear these messages from the display: LOW BATTERY - Internal backup battery charge is low SENSOR DISCONNECT - Oximetry sensor is disconnected from N-600 SENSOR OFF - Sensor is not properly attached to the patient The Adjust Up button is used to increase variable settings of the N-600. The Adjust Down button is used to decrease variable settings of the N-600. 12 OxiMax N-600

Buttons, Indicators, and Alarms The Contrast button is used in conjunction with the Adjust Up and Adjust Down buttons to lighten or darken the display screen. The softkey buttons have multiple uses depending on the legend displayed above each of the four buttons. Front Panel Status Indicators and Components 1 SpO2 Sensor Port (DOC-10 Cable Connection) 2 AC Power Indicator 3 Low Battery Indicator 4 Alarm Silence Indicator 5 Neonate Alarm Limits Indicator 6 Fast Mode Indicator 7 Data In Sensor Indicator 8 Interference Indicator 9 Pulse Search Indicator 10 Speaker (Audible Alarms) Figure 2: Front Panel Status Indicators and Components Home Use Guide 13

Buttons, Indicators, and Alarms Description of Status Indicators This section identifies and describes the function of the status indicators located on the front panel. Refer to Figure 2 on page 13 for the location of each indicator. The AC Power Indicator lights continuously when the N-600 is connected to AC power. It also indicates that the battery is charging. The indicator is off when the N-600 is being powered by the internal battery. The Low Battery Indicator lights continuously when 15 or fewer minutes of battery capacity remains. The Low Battery Indicator flashes when the battery capacity reaches critical condition. (See Low Battery Indicator on page 62.) The Alarm Silence Indicator lights continuously when an audible alarm has been silenced by pressing the Alarm Silence button. The Alarm Silence Indicator flashes when the alarm silence duration has been set to off. The Data In Sensor Indicator lights to indicate that the attached sensor contains a patient sensor event record. The sensor event record information may be viewed or printed. Contact your clinician for more information. 14 OxiMax N-600

Buttons, Indicators, and Alarms The Interference Indicator. The Interference Indicator lights whenever the OxiMax algorithm detects that the incoming signal quality is degraded 1. A blinking Interference Indicator indicates that increased signal processing is being used for tracking the cardiac waveform. A continuously lit Interference Indicator indicates, that to maintain reliable readings, processing of incoming signals is required to a degree that fidelity in tracking rapid SpO2 and HR changes may be reduced. The Pulse Search Indicator lights continuously prior to initial acquisition of a pulse signal and during pulse search. It flashes during a loss-of-pulse condition. The Neonate Alarm Limits Indicator displays when the N-600 alarm limits are set to neonate. No symbol is displayed when the N-600 is set to adult alarm limits. The setting will be established by your clinician. The Fast Response Mode Indicator is displayed when the N-600 is operating in the fast mode. The setting will be established by your clinician. 1. Disruptions to the detected signal waveform, that light the Interference Indicator, can be caused by ambient light, electrical noise, electrosurgical interference, patient activity, or other causes. Home Use Guide 15

Buttons, Indicators, and Alarms BLIP Display Information 1 SatSeconds Indicator 5 2 3 %SPO2 Display (oxygen saturation percentage) %SpO2 Upper and Lower Alarm Limits 4 Pulse Amplitude Indicator (BLIP bar) PULSE RATE Display (Beats Per Minute BPM) Pulse Rate (BPM) Upper and Lower Alarm Limits Figure 3: Blip Display Information 6 7 Softkey Menu Bar Description of BLIP Display Information Note: Although the default display is the PLETH view, the preferred view in the home environment is the BLIP display. Instructions for selecting the BLIP display are found on page 40 of this manual. This section describes the five display components, as identified in the figure above. 16 OxiMax N-600

Buttons, Indicators, and Alarms The SatSeconds Indicator is an alarm management system. The clinician will determine if this feature is appropriate for the patient in the home. The SatSeconds symbol is only displayed if the SatSeconds feature is enabled. The %SPO2 Display (oxygen saturation percentage) reports the percentage of oxygen circulating in the patient s blood system. You will see a decimal point after this value if the upper and/or lower alarm limit has been changed since the N-600 was last powered on. The %SpO2 Alarm Limits displays the currently set upper and lower limits for %SpO2 readings. When a reading exceeds a set limit, an alarm sounds. The Pulse Amplitude Indicator (BLIP BAR) displays the pulse beat and the relative strength or amplitude of each beat. As the detected pulse becomes stronger, more bars light with each pulse. This indicator is available only in the BLIP view. The Pulse Rate Display (BPM) represents the beats per minute of the patient s heart. This reading is also referred to as the patient s pulse rate. You will see a decimal point after this value if the upper and/or the lower alarm limit has been changed since the N-600 was last powered on. The Pulse Rate (BPM) Alarm Limits displays the currently set upper and lower alarm limits for Pulse Rate (BPM) readings. When a reading exceeds a set limit, an alarm sounds. (See Setting Alarm Limits on page 46.) The Softkey Menu Bar displays the current functions for each of the four softkey buttons. Home Use Guide 17

Buttons, Indicators, and Alarms PLETH Display Information 1 PLETH WAVEFORM Display 4 PULSE RATE Display (BEATS PER MINUTE BPM) 2 SatSeconds Indicator 5 Softkey Menu Bar 3 %SPO2 Display (OXYGEN SATURATION PERCENTAGE) Figure 4: Pleth Display Information Description of PLETH View Information This section describes the displayed information when you use the PLETH view to monitor the patient. Note: The alarm limits for oxygen saturation and BPM are not shown on the PLETH view display, as they are in the BLIP view. Press the LIMITS softkey to view the currently set alarm limits when using the PLETH view display. The Pleth Waveform Display continuously updates and displays the patient s pulse beat. The height of the waveform represents the relative strength of the patient s pulse. 18 OxiMax N-600

Buttons, Indicators, and Alarms Rear Panel Components 1 Ground (Equipotential Terminal) 4 Fuse Holder 2 AC Power Connector 5 Supply Voltage Selector Switch 3 Data Port Connector Figure 5: Rear Panel Components Rear Panel Symbols This section describes the symbols located on the rear panel of the N-600. 20 OxiMax N-600

Buttons, Indicators, and Alarms 1 2 Ground symbol (Equipotential Terminal) Data interface 3 Read the documentation before using the equipment. 4 Manufacturing date of N-600 5 Fuse replacement information Figure 6: Rear Panel Symbols Description of Audible Tones and Alarms Table 1 identifies the audible tones and alarms of the N-600. Table 1: Audible Tones and Alarms Function Alarm Silence Reminder Confirmation Tone Description Three beeps that sound approximately every three minutes. Three beeps sound to indicate that default settings have been saved or reset to factory defaults or trend data has been deleted. Home Use Guide 21

Buttons, Indicators, and Alarms Table 1: Audible Tones and Alarms (Continued) Function Invalid Button Press Valid Button Press High Priority Alarm Medium Priority Alarm Low Priority Alarm Power-On Self-Test Pass Pulse Beep Volume Setting Tone Description A short, low-pitched tone indicating that a button has been pressed that is not appropriate for the current state of the N-600. A short, medium-pitched tone indicating that an appropriate button has been pressed. A high-pitched, fast-pulsing tone indicating loss-of-pulse. A medium-pitched, pulsing tone indicating an SpO2 or pulse rate limit violation. A low-pitched, slow-pulsing tone indicating a sensor disconnect, low battery, or N-600 failure. A one-second tone indicating that the N-600 has been turned on and has successfully completed the power-on self-test. A single beep sounds for each detected pulse. The pulse beep tone changes in pitch with changes in the patient s oxygen saturation. A continuous tone that sounds as the alarm volume is adjusted. 22 OxiMax N-600

Setting Up the N-600 This section contains important information regarding the setup of the N-600. Be sure to read and follow all of the warnings and cautions in this section and elsewhere in this manual. Warnings inform you of situations and events you must avoid to prevent serious or fatal injury to either the patient or you. Cautions alert you to exercise care necessary for the safe and effective use of the N-600. WARNING: Locate the N-600 near the patient in a position that ensures it cannot accidently fall on the patient. Failure to do so could result in patient injury. WARNING: Carefully route the oximetry cable between the patient and the N-600 to reduce the possibility of patient entanglement or strangulation. WARNING: Ensure that the speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm tone. WARNING: Make sure that you can hear an audible alarm from other rooms in the home, and when you are using noisy appliances, such as a dishwasher, clothes dryer, television, or radio. Failure to ensure that the alarm volume is appropriate for the environment may place the patient in danger. If you need the volume adjusted, immediately contact the clinician for help. Home Use Guide 23

Setting Up the N-600 WARNING: Do not connect the N-600 to an electrical outlet controlled by a wall switch, because the N-600 may be accidentally turned off. WARNING: To ensure accurate performance and prevent device failure, do not place the N-600 in extreme moisture environments, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure. WARNING: Inspect the N-600, sensor, cables, and connectors before each use. Do not use an N-600 that appears damaged. WARNING: Do not lift the N-600 by the oximetry cable or power cord because the cable or cord could disconnect from the N-600, causing the N-600 to drop on the patient. WARNING: Use only the Nellcor pulse oximetry cable DOC-10 with the N-600. Use of another pulse oximetry cable will have an adverse effect on performance. Do not attach any cable that is intended for computer use to the oximetry sensor port. Do not connect any device other than a Nellcor-approved sensor to the sensor connector. WARNING: The N-600 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the N-600 should be observed to verify normal operation. 24 OxiMax N-600

Setting Up the N-600 Connecting the N-600 to AC Power Caution: The SUPPLY VOLTAGE SELECTOR switch must be set to the correct voltage (115V) to avoid damage to the N-600 and ensure proper battery charging. Caution: Use only the hospital-grade power cord provided with the N-600. 1. Set the SUPPLY VOLTAGE SELECTOR switch to the applicable voltage (115V). 1 Power Connector 2 Supply Voltage Selector Figure 7: Voltage Selector and Power Connector 2. Plug the female connector end of the power cord into the N-600 power connector on the rear of the N-600. Home Use Guide 25

Setting Up the N-600 Figure 8: Power Cord Connection WARNING: Do not plug the N-600 into an electrical outlet controlled by a wall switch, because the N-600 may be accidentally turned off. 3. Plug the male connector of the power cord into a properly grounded AC outlet. 4. Verify that the N-600 s AC Power Indicator is lit. Note: If the AC Power Indicator is not lit, do the following: Ensure that the power cord is fully seated in the power connector on the rear of the N-600. Ensure that the AC power outlet is functioning. 26 OxiMax N-600

Setting Up the N-600 Check and confirm that the supply voltage selector switch is set for 115V. If the AC Power Indicator is still not lit, contact the clinician for further assistance. Home Use Guide 27

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Oximetry Sensors Selecting an Oximetry Sensor WARNING: Before use, carefully read the directions for use that accompany the Nellcor oximetry sensor, 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-approved OXIMAX sensors and pulse oximetry cable with this N-600. Use of other sensors or pulse oximetry cables may cause improper N-600 performance. WARNING: Do not attach any cable to the sensor port connector that is intended for computer use. WARNING: Tissue damage can be caused by incorrect application or duration of use of an oximetry sensor. Inspect the sensor site periodically as directed in the sensor directions for use. WARNING: Do not immerse or wet the sensor. Home Use Guide 29

Oximetry Sensors WARNING: Do not lift the N-600 by the sensor cable or power cord because the cable or cord could disconnect from the N- 600, causing the N-600 to drop on the patient. WARNING: Pulse oximetry readings and pulse signals can be affected by certain environmental factors, oximetry sensor application errors, and certain patient conditions. Refer to the appropriate sections of this manual, including this chapter, for specific information. Oximetry Sensors on page 29 Sensor Performance Considerations on page 57 EMI (Electromagnetic Interference) on page 70 Caution: The sensor disconnect error message and associated alarm indicate that the sensor is either disconnected or the wiring is faulty. If this error occurs, you should immediately check the sensor connection and, if necessary, replace the sensor, the pulse oximetry cable (DOC-10), or both. Contact your clinician before throwing away a used disposable sensor as patient data is recorded by some sensor models. 30 OxiMax N-600

Oximetry Sensors The clinician will assist in the selection of a Nellcor sensor model that is appropriate for the patient, based in part on the patient s weight and activity level. Table 2 lists the available sensor models and patient weight ranges for which each sensor is appropriate. Table 2: Nellcor Oximetry Sensor Models and Patient Weights OXIMAX Sensor OXIMAX Max-Fast adhesive forehead sensor, single-patient-use OXIMAX SoftCare nonadhesive sensor, single-patient-use, preterm infant OXIMAX SoftCare nonadhesive sensor, single-patient-use, neonate OXIMAX SoftCare nonadhesive sensor, single-patient-use, adult OXIMAX adhesive sensor, single-patient-use, adult OXIMAX adhesive sensor, single-patient-use, adult, longer cable 36 inches (91.44 cm) OXIMAX adhesive sensor, single-patient-use, neonatal/adult OXIMAX adhesive sensor, single-patient-use, pediatric OXIMAX adhesive sensor, single-patient-use, infant OXIMAX adhesive sensor, single-patient-use, adult nasal OXIMAX OxiCliq nonadhesive sensor, single-patient-use, adult, reusable cable Model MAX-FAST SC-PR SC-NEO SC-A MAX-A MAX-AL MAX-N MAX-P MAX-I MAX-R OxiCliq A Patient Size >=greater than <=less than >10 kg (>22 lbs) <1.5 kg (<3.3 lbs) 1.5 to 5 kg (3.3 to 11 lbs) >40 kg (>88 lbs) >30 kg (>66 lbs) >30 kg (>66 lbs) <3 kg or >40 kg (<6.6 lbs or >88 lbs) 10 to 50 kg (22to110 lbs) 3 to 20 kg (6.6 to 44 lbs) >50 kg (>110 lbs) >30 kg (>66 lbs) Home Use Guide 31

Oximetry Sensors Table 2: Nellcor Oximetry Sensor Models and Patient Weights (Continued) OXIMAX Sensor OXIMAX OxiCliq nonadhesive sensor, single-patient-use, neonatal/adult, reusable cable OXIMAX OxiCliq nonadhesive sensor, single-patient-use, pediatric, reusable cable OXIMAX OxiCliq nonadhesive sensor, single-patient-use, infant, reusable cable OXIMAX Durasensor finger-clip sensor, reusable, adult OXIMAX Oxiband sensor, reusable, neonatal/adult OXIMAX Oxiband sensor, reusable, pediatric/infant OXIMAX Dura-Y multisite sensor, reusable Model OxiCliq N OxiCliq P OxiCliq I DS-100A OXI-A/N OXI-P/I D-YS Patient Size >=greater than <=less than <3 kg or >40 kg (<6.6 lbs or >88 lbs) 10 to 50 kg (22to110 lbs) 3 to 20 kg (6.6 to 44 lbs) >40 kg (>88 lbs) <3 kg or >40 kg (<6.6 lbs or >88 lbs) <3 kg or >40 kg (<6.6 lbs or >88 lbs) >1 kg (>2.2 lbs) For use with the Dura-Y sensor: Ear clip (Reusable, nonsterile) Pedi-Check TM pediatric spot-check clip (Reusable, nonsterile) D-YSE D-YSPD >30 kg (>66 lbs) <3 kg or >40 kg (<6.6 lbs or >88 lbs) Note: A DOC-10 pulse oximetry cable is always required to connect a sensor to the N-600 sensor port. (See Connecting a Sensor to the N-600 on page 37.) 32 OxiMax N-600

Using the N-600 Introduction This chapter contains the instructions for the routine operation of the N-600 in a home-use environment. If you have any questions, or are unsure how to proceed, always contact the clinician for clarification. Note: Many instructions indicate that the N-600 should be in the normal monitoring mode. Normal monitoring mode means that: the N-600 is turned on, a sensor is connected to the N-600, via the DOC-10 Pulse Oximetry Cable, the sensor is applied to the patient, the patient s %SpO2 (oxygen saturation percentage) and pulse rate readings (BPM) are being reported, and no error conditions exist. Factory Default Settings Unless otherwise instructed by the clinician, you will use the preset factory default settings for the N-600 parameters. The clinician may override the factory default settings with patient-specific settings. Check with the clinician for more information. Home Use Guide 33

Using the N-600 The table below lists each parameter, its range in value or setting, and the factory default setting. The parameters may be set on an individual basis, as instructed by the clinician, and these altered settings remain in effect until the N-600 is turned off. If you turn off your N-600, you must reenter the values provided by the clinician when the N-600 is turned on again. Caution: Each time the N-600 is used, check the alarm limits to ensure that they are appropriate for the patient you are monitoring. Table 3: Parameter Factory Defaults and Ranges Parameter Ranges/Selections Adult/ Pediatric Defaults Neonate Defaults Monitoring Mode Adult/Pediatric, Neonate Adult/ Pediatric Neonate %SpO2 Upper Alarm Limit %SpO2 Lower Alarm Limit Pulse Rate Upper Alarm Limit Pulse Rate Lower Alarm Limit Alarm Silence Duration Lower Alarm Limit setting plus 1 to 100% 20% to Upper Alarm Limit setting minus 1 Lower Alarm Limit setting plus 1 to 250 bpm. 30 beats per minute (BPM) to Upper Alarm Limit setting minus 1 Alarms 30, 60, 90, 120 seconds 100% 95% 85% 80% 170 bpm 190 bpm 40 bpm 90 bpm 60 seconds 60 seconds Alarms Allow Off Yes/No Yes Yes Off Reminder Yes/No Yes Alarm Volume 1 to 10 7 7 Yes 34 OxiMax N-600

Using the N-600 Table 3: Parameter Factory Defaults and Ranges (Continued) Parameter Ranges/Selections Adult/ Pediatric Defaults Neonate Defaults Default Display Format Pleth, Blip Pleth Pleth Display Contrast Low to High Medium Medium Language English, French, German, Dutch, Portuguese, Spanish, Italian, Swedish English English Limits Adult, Neonate Adult Neonate Pulse Beep Volume 0 to 10 4 4 SatSeconds Off, 10, 25, 50, 100 Off Off Sensor Messages Enabled? Yes, No Yes Yes Turning On the N-600 Before using the N-600 to monitor the patient, verify that the N-600 is working properly and is safe to use. Each time the N-600 is turned on, it conducts a series of internal checks to verify proper operation, as described in the following section. Caution: If any indicator or display element does not light when the N-600 is turned on, do not use the N-600. Instead, contact the clinician to report the problem. Caution: If the N-600 speaker does not sound a one-second tone shortly after the power comes on, do not use the N-600. Instead, contact the clinician to report the problem. Home Use Guide 35

Using the N-600 1. Turn on the N-600 by pressing the On/Standby button. 2. Ensure that all of the front panel indicators illuminate. 3. Once the display test portion of power-on sequence is complete, the N-600 software version is displayed for approximately five seconds. 4. If the N-600 detects an internal problem during the internal check, an alarm tone sounds and the N-600 displays the letters EEE followed by an error code number, similar to the example below. If an error code is displayed, contact the clinician immediately to report that the N-600 is malfunctioning. 36 OxiMax N-600

Using the N-600 5. After successful completion of the internal check, the N-600 sounds a one-second tone indicating that the N-600 has passed the test. Caution: If you do not hear the one-second POST pass tone, do not use the N-600. Instead, contact the clinician to report the problem. Caution: Do not place objects in front of the N-600 speaker. Doing so could prevent you from hearing an audible alarm while monitoring the patient. Following successful completion of the self test, the N-600 will immediately move into the patient monitoring mode. If there is no sensor connected to the N-600, or if the connected sensor is not applied to the patient, the N-600 will not display readings for %SpO2 or pulse rate. If you have a sensor connected to the N-600 and properly applied to the patient before the completion of the internal check, the N-600 will begin searching for the pulse. Upon successfully detecting a pulse, the N-600 will begin displaying the %SpO2 and pulse rate. Connecting a Sensor to the N-600 A Nellcor pulse oximetry cable, model DOC-10, must always be used to connect a sensor to the N-600. Refer to the directions for use accompanying the DOC-10 cable for additional information. Connect the DOC-10 cable to the N-600 and plug the sensor into the DOC-10 cable, as instructed below. Home Use Guide 37

Using the N-600 1 SpO2 Sensor Port 1. Connect the DOC-10 pulse oximetry cable to the oximetry sensor port located on the front panel of the N-600. 2. Open the plastic latch at the opposite end of the cable and, with NELLCOR facing up on the sensor connector, plug the sensor and the DOC-10 cable together. Snap the plastic latch down over the connectors. The N-600 briefly displays the model name of the sensor. Figure 9: Connecting Sensor and DOC-10 Cable 3. Apply the sensor to the patient, as instructed by the clinician. Be sure to also read the directions for use accompanying the sensor. 38 OxiMax N-600

Using the N-600 4. The N-600 searches for a valid pulse, indicated by the lighted Pulse Search Indicator. 5. When a valid pulse is detected, the N-600 enters the monitoring mode and displays the patient readings (%SpO2 and pulse rate). 6. Look for movement of the BLIP bar or the pleth waveform as an indication that the N-600 is displaying real-time data. Listen for the pulse beep tone. If the pulse tone does not sound with each pulse, it is an indication that the pulse beep volume is set to zero, or that the speaker is malfunctioning, or that the pulse signal is corrupted. See Setting the Pulse Beep Volume on page 41. Note: If the sensor is not applied to the patient, or it is improperly applied to the patient, the N-600 may display the following message. Home Use Guide 39

Using the N-600 Selecting the BLIP View The BLIP view displays %SpO2, pulse rate, BLIP bar, and alarm limits in a larger format for easier viewing. It is better suited for viewing patient data in the home environment than the factory default PLETH view. (See Description of BLIP Display Information on page 16 for further details regarding the BLIP display.) With the N-600 in the normal monitoring mode: 1. Press the SETUP softkey. 2. Press the VIEW softkey. 3. Press the BLIP softkey. 40 OxiMax N-600

Using the N-600 Setting the Pulse Beep Volume After the N-600 begins reporting valid %SpO2 and pulse rate readings, you may adjust the pulse beep volume up or down. Press and hold the Adjust Up or Adjust Down button to increase or to decrease pulse beep volume. Setting the Alarm Volume If the volume of the audible alarm function is too soft or too loud, contact the clinician for assistance. WARNING: Make sure that you can hear an audible alarm from other rooms in the home, and when you are using noisy appliances, such as a dishwasher, clothes dryer, television, or radio. Failure to ensure that the alarm volume is appropriate for the environment may place the patient in danger. If you need the volume adjusted, immediately contact the clinician for help. Turning the Display Backlight Off or On After you power on the N-600, the display backlight will be on. To turn the backlight off, press the LIGHT softkey. When the backlight is off, any one of the following events will turn on the backlight: you press one of the softkeys you press the Contrast button Home Use Guide 41

Using the N-600 you press the Alarm Silence button the N-600 detects an alarm condition Adjusting Display Contrast You can adjust the display contrast to improve readability of the display. 1. Press the Contrast button, located to the right of the softkeys. 2. Press the Adjust Up or Adjust Down button until the desired contrast is obtained. 3. Press the Contrast button to exit. Setting the Date and Time With the N-600 in the normal monitoring mode: 1. Press the SETUP softkey. 2. Press the NEXT softkey. 3. Press the CLOCK softkey. 42 OxiMax N-600

Using the N-600 4. Press the SET softkey. 5. Press the SELECT softkey to select: TIME HOURS: MINUTES : SECONDS (for example, 6:46:05) DATE DAY - MONTH - YEAR (for example, 30-JAN-06) 6. Use the Adjust Up or Adjust Down buttons to change the selected value. 7. Press the EXIT softkey. Adult-Pediatric and Neonatal Settings The factory default patient monitoring mode is ADULT-PEDIATRIC, which uses upper and lower alarm limits for oxygen saturation and pulse rate that are typically appropriate for adult and pediatric patients. If you are monitoring a neonate or infant, you can change to the neonatal monitoring mode by pressing the LIMITS softkey and selecting NEO. The upper and lower limits for monitoring a neonate or infant differ from those for an adult or a pediatric patient. Home Use Guide 43

Using the N-600 If you modify the default value(s) of alarm limits in either the adult or neonate monitoring mode, the change will remain in effect only until the N-600 is turned off. You will need to reenter your limit changes each time you turn on the N-600. Caution: Each time the N-600 is used, check the alarm limits and the monitoring mode to ensure that they are appropriate for the patient you are monitoring. The clinician will advise you as to whether or not you should use alarm limits other than the default values when monitoring the patient. If needed, the clinician can program the N-600 to override the default limits, using instead the settings appropriate for the patient s needs. You can discuss this option with the clinician. Refer to Table 3 on page 34 for the adult/pediatric and neonate factory default limit settings. Selecting the Monitoring Mode With the N-600 in the normal monitoring mode: 1. Press the LIMITS softkey.the alarm limits for the currently selected monitoring mode are displayed. or 44 OxiMax N-600

Using the N-600 1. Press the ADULT or NEO softkey to select ADULT/ PEDIATRIC limits or NEONATE/INFANT limits, respectively, based on the patient type you are monitoring. If the NEO mode is selected, NEO will appear in the lower right of the display and will be visible at the patient monitoring screen. 2. Press the SELECT softkey as needed to select the parameter to be adjusted. 3. Use the Adjust Up or Adjust Down button to increase or decrease the selected limit settings. 4. Repeat steps 3 and 4 as necessary to complete the ALARM LIMITS setup. 5. To accept the changes, let the display time out or press the EXIT softkey to exit the display and return to normal monitoring. Home Use Guide 45

Using the N-600 Note: Remember that if you require the NEONATE/INFANT monitoring mode for the patient, you must reselect this mode each time you power on the N-600. Otherwise, the default monitoring mode (ADULT/PEDIATRIC) will be in effect. The clinician can change the power-on default to NEONATE if required. Setting Alarm Limits The ALARM LIMIT display allows you to adjust the upper and lower saturation and pulse rate limits. The ALARM LIMIT display includes the alarm limit table and the current measured %SpO2 and pulse rate. The title of the alarm limit table indicates whether the N-600 is in ADULT or NEONATE monitoring mode. A decimal point after the displayed %SpO2 or pulse rate values indicate that the respective alarm limits have been changed from the power-on defaults. With the N-600 in the normal monitoring mode: 1. Press the LIMITS softkey. The alarm limits for the current monitoring mode are displayed. or 46 OxiMax N-600

Using the N-600 2. If necessary, press the ADULT or NEO softkey to change the Adult-Pediatric or Neonatal alarm limits screen. 3. Press the SELECT softkey as needed to select the parameter to be adjusted. 4. Use the Adjust Up or Adjust Down buttons to increase or decrease the selected limit parameter. 5. Repeat steps 3, 4, and 5 as necessary to complete the alarm limits setup. 6. To accept the changes, let the display time out or press the EXIT softkey to exit the display and return to normal monitoring. Note: Limit changes, as well as the selection of the NEONATAL monitoring mode, will only be in effect as long as the N-600 remains turned on. When you turn the N-600 off and back on, the factory default limits will again be in effect. Home Use Guide 47

Using the N-600 The clinician may set up the N-600 to always use settings other than the factory default values, based on the needs of the patient. These alternate settings are referred to as institutional settings and if the clinician programs them in the system, the N-600 will use these as the power-up parameters in place of the factory default parameter values. Alarm Limit Changed Indicator Alarm limits that have been changed from the factory default settings are identified by a decimal point after the displayed reading (%SPO2 or BPM). The changed parameter is also identified by a decimal point on the alarm limits screen. Sensor Messages The N-600 suggests possible solutions for sensor placement when the N-600 is unable to report the patient s oxygen saturation. The N-600 will display sensor messages, based on the type of sensor in use, that suggest actions to resolve the problem. You can enable or disable the sensor messages feature. The default for this feature is enabled. Condition messages are followed by action messages. For example, up to three condition messages may be displayed in priority order, with the highest priority displayed on top. 48 OxiMax N-600

Using the N-600 Remove the condition display by pressing the EXIT softkey. Once exited, the condition display will not return until a new condition occurs. POOR SIGNAL CONDITION: -SMALL PULSES -INTERFERENCE HELP %SP02 100 BPM EXIT --- --- If you press the HELP softkey from the condition message display, the action messages for the reported condition(s) are displayed. Up to five action messages may be displayed. Press NEXT, BACK, and EXIT softkeys to navigate through multiple screens that may be required to display all of the action messages. Sensor Message Setup Use this procedure to enable or disable the advanced sensor message feature. If you disable this feature, neither POOR SIGNAL CONDITION or SUGGESTED ACTION will be displayed. With the N-600 in the normal monitoring mode: Press the SETUP softkey. Home Use Guide 49

Using the N-600 1. Press the SENSOR softkey. 2. Press the MSG softkey. 3. Press the Adjust Up or Adjust Down button to toggle the ENABLE message from YES to NO. 4. Press the EXIT softkey. Selecting the Display Language The N-600 can be programmed to display information in one of eight languages. The languages available are ENGLISH, DANSK (Danish), FRANCAIS (French), DEUTSCH (German), ITALIANO (Italian), ESPAÑOL (Spanish), NEDERLANDS (Dutch), NORSK (Norwegian), PORT (Portuguese), SUOMI (Finnish), and SVERIGE (Swedish). Consult with the clinician before attempting to change the displayed language. Note: When you turn the N-600 off and back on, the factory default language, English, will again be in use. The clinician can program the N-600 for a different default language, if appropriate. 50 OxiMax N-600

Using the N-600 With the N-600 in the normal monitoring mode: 1. Press the SETUP softkey. 2. Press the NEXT softkey. 3. Press the LANG softkey. 4. Use the Adjust Up or Adjust Down buttons to select the desired language. 5. Press the EXIT softkey. Patient Trend Data The N-600 stores patient pulse rate and %SpO2 readings in memory, creating a patient trend data history that can be reviewed at any time by the clinician. The data are reviewed using the N-600 software. Home Use Guide 51

Using the N-600 Caution: Contact your clinician before throwing away a used disposable sensor as patient data is recorded by some sensor models. If it is necessary for you to access the patient data stored in the N-600, or the event data stored in the sensor, the clinician will provide instructions for accessing and viewing this data. Nurse Call Feature The N-600 has a feature called NURSE CALL. This feature is designed to assist qualified personnel in hospitals or similar health care centers. The nurse call mode, shown as NCALL, is an option accessed in the SETUP menu. This will not function in the home use environment. If you should enter the nurse call setup mode by accident, simply press the EXIT softkey to return to the main SETUP menu. 52 OxiMax N-600

Prompt and Error Messages Introduction Prompt and error messages are displayed in the area normally reserved for softkey labels. Prompt messages prompt you for a response, while error messages provide information to you. The figures below provide an example of a prompt and an error message respectively. Managing Prompt and Error Messages Use Table 4 and Table 5 to determine what causes a specific message to be displayed, and how you can clear it. In these tables, the time-out value is the maximum time that the particular message will remain on the display. If the time-out is None, the message Home Use Guide 53

Prompt and Error Messages will remain on the display until you change the condition, by responding to the prompt (prompt message), by resolving the error condition (error message), or by pressing the Alarm Silence button (prompt or error message). Messages are prioritized so that more important messages will overwrite lower priority messages. Messages of the same priority will be displayed in order of occurrence. For multiple messages, lower priority messages will be displayed when higher priority conditions are cleared. Table 4: Error Message Message Timeout (sec.) When Displayed How Cleared/ Action CLOCK SETTING LOST None The N-600 detects that the real time clock has stopped running. This will occur when both battery and AC power are lost. Turn the N-600 off and back on again. Reenter date and time.see Setting the Date and Time on page 42. Recharge or replace the battery. DEFAULTS LOST None The N-600 detects that power-on default settings have been lost. LOW BATTERY None The N-600 is on battery power and the battery charge is low. Turn the N-600 off and back on again. Verify N-600 settings before using N-600. Connect the N-600 to AC power to recharge the battery. Acknowledge the LOW BATTERY error by pressing the Alarm Silence button. 54 OxiMax N-600

Table 4: Error Message (Continued) Prompt and Error Messages Message Timeout (sec.) When Displayed How Cleared/ Action SENSOR OFF None Sensor is not properly attached to the patient. When the sensor is reapplied to the patient or when the SENSOR OFF message is acknowledged by pressing the Alarm Silence button. SENSOR DISCONNECTED None The sensor is disconnected from the N-600. When the sensor is reconnected or when the sensor disconnection is acknowledged by pressing the Alarm Silence button. Table 5: Prompt Messages Message Timeout (sec.) When Displayed How Cleared SENSOR TYPE 5 First message displayed when a sensor is connected to the N-600. Time-out DATA IN SENSOR DELETE TRENDS? 5 A sensor containing data is connected to the N-600. 10 You attempt to delete trend data from memory by pressing the DELETE softkey in the Trend menu. On time-out, sensor disconnect, or pressing the Alarm Silence button, whichever comes first. After you respond (YES or NO) to the prompt. Home Use Guide 55

Prompt and Error Messages Table 5: Prompt Messages (Continued) READING TRENDS... None The N-600 needs more than 4 to 6 seconds to retrieve trend data from memory. When sensor data is completely retrieved or ABORT is selected. DATA TYPE EVENT/ SPO2+BPM DATA TYPE: EVENT/SPO2 5 A blank event sensor is connected to a N-600 with event data type set to SPO2+BPM. 5 A blank event sensor is connected to a N-600 with event data type set to SPO2. On time-out, sensor disconnect, or pressing the Alarm Silence button, whichever comes first. On time-out, sensor disconnect, or pressing the Alarm Silence button, whichever comes first. 56 OxiMax N-600