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Nellcor OxiMax N595 Home Use Guide

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N-595<br />

Pulse Oximeter<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong><br />

Important: Read this manual before using the monitor<br />

If you need help, call the 24-hour hotline of the medical equipment dealer listed below:


<strong>Nellcor</strong> Puritan Bennett Inc. is an affiliate of Tyco Healthcare. <strong>Nellcor</strong>, Durasensor, OxiCliq, OxiBand,<br />

Dura-Y, MAX-FAST, SatSeconds, Pedi-Check and OXIMAX are trademarks of <strong>Nellcor</strong> Puritan Bennett<br />

Inc.<br />

To obtain information about a warranty, if any, contact <strong>Nellcor</strong>’s Technical Services Department at<br />

1.800.635.5267, or your local <strong>Nellcor</strong> representative.<br />

Purchase of this instrument confers no express or implied license under any<br />

<strong>Nellcor</strong> Puritan Bennett patent to use the instrument with any sensor that is not manufactured or<br />

licensed by <strong>Nellcor</strong> Puritan Bennett.<br />

Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643; 4,653,498;<br />

4,700,708; 4,770,179; Re. 35,122; 4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136; 5,351,685;<br />

5,368,026; 5,485,847; 5,533,507; 5,662,106; 5,853,364; and 6,083,172.


Contents<br />

Important Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1<br />

Introduction ...........................................................................1<br />

Definitions .............................................................................1<br />

If You Need Help ..................................................................2<br />

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3<br />

Warnings ..............................................................................3<br />

Cautions ...............................................................................5<br />

Purpose of the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7<br />

Purpose of the N-595 ...........................................................7<br />

Role of the Clinician .............................................................8<br />

Buttons, Indicators, and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9<br />

Front Panel Control Buttons .................................................9<br />

Function of Front Panel Control Buttons ............................10<br />

Front Panel Status Indicators and Components .................11<br />

Description of Status Indicators ..........................................11<br />

BLIP Display Information ....................................................13<br />

Description of BLIP Display Information .............................13<br />

PLETH Display Information ................................................15<br />

Description of PLETH View Information .............................15<br />

Front Panel Symbol ............................................................16<br />

Rear Panel Components ....................................................16<br />

Rear Panel Symbols ...........................................................17<br />

Description of Audible Tones and Alarms ..........................18<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong><br />

i


Contents<br />

Setting Up the N-595 Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19<br />

Connecting the N-595 to AC Power ................................... 21<br />

Oximetry Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23<br />

Selecting an Oximetry Sensor ........................................... 23<br />

Using the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27<br />

Introduction ........................................................................ 27<br />

Factory Default Settings ..................................................... 27<br />

Turning On the Monitor ...................................................... 29<br />

Connecting a Sensor to the Monitor .................................. 31<br />

Selecting the BLIP View ..................................................... 33<br />

Setting the Pulse Beep Volume ......................................... 34<br />

Setting the Alarm Volume .................................................. 34<br />

Turning the Display Backlight Off or On ............................. 34<br />

Adjusting Display Contrast ................................................. 35<br />

Setting the Date and Time ................................................. 35<br />

Adult-Pediatric and Neonatal Settings ....................................36<br />

Selecting the Monitoring Mode .......................................... 37<br />

Setting Alarm Limits ........................................................... 38<br />

Alarm Limit Changed Indicator ........................................... 40<br />

Sensor Messages .............................................................. 40<br />

Sensor Message Setup ...................................................... 41<br />

Selecting the Display Language ........................................ 42<br />

Patient Trend Data ............................................................. 43<br />

Nurse Call Feature ............................................................. 43<br />

Prompt and Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45<br />

Introduction ........................................................................ 45<br />

Managing Prompt and Error Messages ............................. 45<br />

Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49<br />

Sensor Performance Considerations ................................. 49<br />

ii N-595


Contents<br />

Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53<br />

Operating on Battery Power ...............................................53<br />

Automatic Shutdown to Conserve Battery ..........................53<br />

Recharging the Battery .......................................................54<br />

Low Battery Indicator ..........................................................54<br />

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57<br />

Error Codes ........................................................................57<br />

Solving Problems ...............................................................57<br />

EMI (Electromagnetic Interference) ....................................60<br />

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63<br />

Service ...............................................................................63<br />

Periodic Safety Checks ......................................................63<br />

Cleaning .............................................................................63<br />

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65<br />

Performance .......................................................................65<br />

Electrical .............................................................................66<br />

Environmental Conditions ..................................................67<br />

Physical Description ...........................................................69<br />

Compliance ........................................................................69<br />

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong><br />

iii


Contents<br />

Figures<br />

Figure 1: Front Panel Control Buttons ............................... 9<br />

Figure 2: Front Panel Status Indicators and Components11<br />

Figure 3: Blip Display Information.................................... 13<br />

Figure 4: Pleth Display Information.................................. 15<br />

Figure 5: Rear Panel Components .................................. 16<br />

Figure 6: Rear Panel Symbols......................................... 17<br />

Figure 7: Voltage Selector and Power Connector ........... 21<br />

Figure 8: Power Cord Connection ................................... 22<br />

Figure 9: Connecting Sensor and DOC-10 Cable ........... 32<br />

iv N-595


Contents<br />

List of Tables<br />

Table 1: Audible Tones and Alarms.................................18<br />

Table 2: <strong>Nellcor</strong> Oximetry Sensor Models and Patient<br />

Weights .............................................................25<br />

Table 3: Parameter Factory Defaults and Ranges ..........28<br />

Table 4: Error Message ...................................................46<br />

Table 5: Prompt Messages..............................................47<br />

Table 6: Specifications.....................................................65<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong><br />

v


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Important Information<br />

Introduction<br />

This manual is for the home caregiver—the person who provides<br />

care for a patient monitored by the N-595 pulse oximeter in the<br />

home. As the home caregiver, it is important that you read this<br />

entire manual before you use the monitor.<br />

This manual contains important safety information and monitor<br />

instructions. If you do not understand any part of this information,<br />

ask the clinician to explain it to you.<br />

Definitions<br />

Clinician:<br />

In this manual, the term “clinician” means the trained health care<br />

professional who assists you with monitoring the patient and using<br />

the N-595 monitor in your home. This person can be the doctor or<br />

nurse who is treating the patient, or some other trained health care<br />

professional.<br />

Normal Monitoring<br />

Mode:<br />

Normal monitoring mode means that:<br />

• the monitor is turned on,<br />

• a sensor is connected to the monitor, via the DOC-10 Pulse<br />

Oximetry Cable,<br />

• the sensor is applied to the patient,<br />

• the patient’s %SpO2 (oxygen saturation percentage) and pulse<br />

rate readings (BPM) are being reported, and<br />

• no error conditions exist.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 1


Important Information<br />

Oxygen<br />

Saturation:<br />

A measurement of the percentage of oxygen circulating in the<br />

patient’s blood. Oxygen saturation is also identified as %SpO2.<br />

Pulse Amplitude:<br />

The relative strength of the patient’s pulse. A higher pulse<br />

amplitude indicates a stronger pulse. A lower pulse amplitude<br />

indicates a weaker pulse.<br />

Pulse Oximeter:<br />

A medical device that measures a patient’s pulse rate and oxygen<br />

saturation in the blood. The N-595 monitor is a pulse oximeter.<br />

Pulse Rate:<br />

A measurement of the number of times the patient’s heart beats per<br />

minute. Pulse rate is also called beats per minute or BPM.<br />

Sensor:<br />

A sensor is an accessory used to collect and send patient<br />

information to the pulse oximeter monitor. One end of the sensor is<br />

attached to the patient’s finger, toe, ear lobe, or forehead and the<br />

other end of the sensor connects to the monitor cable. The sensor<br />

collects measurements by sensing the patient’s pulse rate and<br />

percentage of oxygen in the blood, and sends this information to the<br />

monitor.<br />

If You Need Help<br />

Contact the clinician if you have any questions or concerns about<br />

using the N-595 monitor. If you believe the monitor is not<br />

functioning properly, always notify the clinician, who may be able<br />

to correct the problem.<br />

If you require assistance in operating the equipment, and are unable<br />

to contact the clinician, call the 24-hour hotline of your medical<br />

equipment dealer. Keep the dealer’s business card with this manual.<br />

That card shows the hotline number.<br />

2 N-595


Safety Information<br />

Warnings<br />

Warnings in this manual are identified by the WARNING symbol<br />

shown above.<br />

Warnings alert you to potential serious outcomes (death, injury, or<br />

adverse events) to you or the patient. Contact the clinician if you<br />

have any questions regarding the warnings in this manual.<br />

WARNING: Explosion hazard. Do not use the N-595 pulse<br />

oximeter in the presence of flammable anesthetics or gases.<br />

WARNING: Chemicals from a broken LCD display panel are<br />

toxic when ingested. <strong>Use</strong> caution when handling a monitor with<br />

a broken display panel.<br />

WARNING: Pulse oximetry readings and pulse signals can be<br />

affected by certain environmental conditions, oximetry sensor<br />

application errors, and certain patient conditions. Refer to the<br />

appropriate sections of this manual, including this chapter, for<br />

specific safety information.<br />

• Oximetry Sensors, page 23<br />

• Sensor Performance Considerations, page 49<br />

• EMI (Electromagnetic Interference), page 60<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 3


Safety Information<br />

WARNING: The use of accessories, oximetry sensors, and<br />

cables other than those specified in this manual may result in<br />

inaccurate readings of the N-595 monitor.<br />

WARNING: Do not lift the monitor by the oximetry cable or<br />

power cord because the cable or cord could disconnect from the<br />

monitor, causing the monitor to drop on the patient.<br />

WARNING: Make sure that the speaker is clear of any<br />

obstruction. Failure to do so could result in an inaudible alarm<br />

tone.<br />

WARNING: Make sure that you can hear an audible alarm<br />

from other rooms in the home, and when you are using noisy<br />

appliances, such as a dishwasher, clothes dryer, television, or<br />

radio. Failure to ensure that the alarm volume is appropriate<br />

for the environment may place the patient in danger. If you<br />

need the volume adjusted, immediately contact the clinician for<br />

help.<br />

4 N-595


Safety Information<br />

Cautions<br />

Cautions are identified by the CAUTION symbol shown above.<br />

Cautions alert you to exercise care necessary for the safe and<br />

effective use of the N-595 monitor.<br />

Caution: Federal law (U.S.A.) restricts this device to sale by or<br />

on the order of a physician.<br />

Caution: The oximetry sensor disconnect error message and<br />

associated alarm indicate that the sensor is either disconnected<br />

or the wiring is faulty. Check the sensor connection and, if<br />

necessary, replace the sensor, pulse oximetry cable, or both. If<br />

necessary, contact the clinician for assistance.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 5


(Blank Page)


Purpose of the Monitor<br />

WARNING: The monitor is only a warning device. You must<br />

take action, as directed by the clinician, when an alarm occurs.<br />

The monitor cannot act for you.<br />

WARNING: The monitor and the oximetry sensor are<br />

prescription devices. <strong>Use</strong> only on the patient for whom<br />

prescribed and only as directed by the clinician.<br />

Purpose of the N-595<br />

The N-595 monitor can be used for patients of all ages—infants,<br />

children, and adults. The clinician will assist you with the selection<br />

and use of the appropriate oximetry sensor, based on the size and/or<br />

age of the patient. (See the chapter, Oximetry Sensors, beginning on<br />

page 23.)<br />

The N-595 monitor continuously measures the patient’s pulse rate<br />

and the percentage of oxygen circulating in the blood. When either<br />

the patient’s pulse rate or the percentage of oxygen goes below or<br />

above a pre-set alarm limit, the monitor warns you by sounding an<br />

alarm, lighting an indicator light, and/or flashing a number.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 7


Purpose of the Monitor<br />

Role of the Clinician<br />

The clinician is a trained health care professional who will:<br />

• order a monitor for use in your home<br />

• set up the monitor for you<br />

• assist you with monitoring the patient<br />

• review the monitored results and the patient’s condition<br />

• show you how to use the monitor<br />

• select a sensor for use with the monitor<br />

• show you how to respond to alarms<br />

• show you how to set the alarm limits<br />

• answer your questions about the monitor<br />

• ensure that the monitor is working correctly<br />

• follow up with you on a regular basis to make sure the monitor is<br />

meeting your needs<br />

8 N-595


Buttons, Indicators, and Alarms<br />

This section introduces you to the control buttons, status indicators,<br />

and symbols on the front and rear panels of your monitor. Audible<br />

tones and alarms are also described. Familiarize yourself with this<br />

section before using the monitor.<br />

Front Panel Control Buttons<br />

1<br />

2<br />

POWER ON/OFF<br />

Button<br />

ALARM SILENCE<br />

Button<br />

5 CONTRAST Button<br />

6 Softkeys<br />

3 ADJUST UP Button 7 Softkey Menu Bar<br />

4<br />

ADJUST DOWN<br />

Button<br />

Figure 1: Front Panel Control Buttons<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 9


Buttons, Indicators, and Alarms<br />

Note: A valid button press, except the POWER ON/OFF button,<br />

should cause the monitor to sound a valid or an invalid tone.<br />

If the button pressed fails to emit a tone, contact the clinician<br />

immediately.<br />

Function of Front Panel Control Buttons<br />

This section identifies and describes the function of each control<br />

button located on the front panel. Refer to Figure 1 on page 9 for<br />

the location of each button.<br />

The POWER ON/OFF button is used to turn the N-595 monitor on<br />

or off.<br />

The ALARM SILENCE button is used to silence current audible<br />

alarms for the alarm silence duration period, which is typically one<br />

minute. If an audible alarm condition still exists after the alarm<br />

silence duration had timed out, the alarm will sound again.When an<br />

alarm has been silenced, pressing the button again reactivates, or<br />

“unsilences” the alarm.<br />

<strong>Use</strong> the ALARM SILENCE button to clear these messages from the<br />

display:<br />

• LOW BATTERY - Internal backup battery charge is low<br />

• SENSOR DISCONNECT - Oximetry sensor is disconnected<br />

from monitor<br />

• SENSOR OFF - Sensor is not properly attached to the patient<br />

The ADJUST UP button is used to increase variable settings of the<br />

monitor.<br />

The ADJUST DOWN button is used to decrease variable settings of<br />

the monitor.<br />

The CONTRAST button is used in conjunction with the ADJUST<br />

UP and ADJUST DOWN buttons to lighten or darken the display<br />

screen.<br />

The softkey buttons have multiple uses depending on the legend<br />

displayed above each of the four buttons.<br />

10 N-595


Buttons, Indicators, and Alarms<br />

Front Panel Status Indicators and Components<br />

1 SpO2 Sensor Port (DOC-10 Cable Connection)<br />

2 AC POWER Indicator<br />

3 LOW BATTERY Indicator<br />

4 ALARM SILENCE Indicator<br />

5 DATA IN SENSOR Indicator<br />

6 MOTION Indicator<br />

7 PULSE SEARCH Indicator<br />

8 Speaker (Audible Alarms)<br />

Figure 2: Front Panel Status Indicators and Components<br />

Description of Status Indicators<br />

This section identifies and describes the function of the status<br />

indicators located on the front panel. Refer to Figure 2 on page 11<br />

for the location of each indicator.<br />

The AC POWER Indicator lights continuously when the N-595 is<br />

connected to AC power. It also indicates that the battery is<br />

charging. The indicator is off when the monitor is being powered<br />

by the internal battery.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 11


Buttons, Indicators, and Alarms<br />

The LOW BATTERY Indicator lights continuously when 15 or<br />

fewer minutes of battery capacity remains. The LOW BATTERY<br />

Indicator flashes when the battery capacity reaches critical<br />

condition. (See Low Battery Indicator on page 54.)<br />

The ALARM SILENCE Indicator lights continuously when an<br />

audible alarm has been silenced by pressing the ALARM SILENCE<br />

button. The ALARM SILENCE Indicator flashes when the alarm<br />

silence duration has been set to off.<br />

The DATA IN SENSOR Indicator lights to indicate that the attached<br />

sensor contains a patient sensor event record. The sensor event<br />

record information may be viewed or printed. Contact your<br />

clinician for more information.<br />

The MOTION Indicator lights continuously when the monitor<br />

detects that the sensor site on the patient is in motion.<br />

The PULSE SEARCH Indicator lights continuously prior to initial<br />

acquisition of a pulse signal and during Pulse Search. It flashes<br />

during a loss-of-pulse condition.<br />

12 N-595


Buttons, Indicators, and Alarms<br />

BLIP Display Information<br />

1 SatSeconds Indicator 5<br />

2<br />

3<br />

4<br />

%SPO2 Display (OXYGEN<br />

SATURATION PERCENTAGE)<br />

%SPO2 UPPER and LOWER<br />

ALARM Limits<br />

PULSE AMPLITUDE Indicator<br />

(BLIP BAR)<br />

PULSE RATE Display<br />

(BEATS PER MINUTE –BPM)<br />

Figure 3: Blip Display Information<br />

6<br />

PULSE RATE (BPM) UPPER<br />

and LOWER ALARM Limits<br />

7 Softkey Menu Bar<br />

Description of BLIP Display Information<br />

Note: Although the default display is the PLETH view, the<br />

preferred view in the home environment is the BLIP display.<br />

Instructions for selecting the BLIP display are found on page<br />

33 of this manual.<br />

This section describes the five display components, as identified in<br />

the figure above.<br />

The SatSeconds Indicator is an alarm management system. The<br />

clinician will determine if this feature is appropriate for the patient<br />

in the home. The SatSeconds symbol is only displayed if the<br />

SatSeconds feature is enabled.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 13


Buttons, Indicators, and Alarms<br />

The %SPO2 Display (OXYGEN SATURATION PERCENTAGE)<br />

reports the percentage of oxygen circulating in the patient’s blood<br />

system. You will see a decimal point after this value if the upper<br />

and/or lower alarm limit has been changed since the monitor was<br />

last powered on.<br />

The %SPO2 ALARM LIMITS displays the currently set upper and<br />

lower limits for %SpO2 readings. When a reading exceeds a set<br />

limit, an alarm sounds.<br />

The PULSE AMPLITUDE Indicator (BLIP BAR) displays the pulse<br />

beat and the relative strength or amplitude of each beat. As the<br />

detected pulse becomes stronger, more bars light with each pulse.<br />

This indicator is available only in the blip view.<br />

The PULSE RATE Display (BPM) represents the number of times<br />

per minute that the patient’s heart beats. This reading is also<br />

referred to as the patient’s pulse rate. You will see a decimal point<br />

after this value if the upper and/or the lower alarm limit has been<br />

changed since the monitor was last powered on.<br />

The PULSE RATE (BPM) ALARM LIMITS displays the currently set<br />

upper and lower alarm limits for Pulse Rate (BPM) readings. When<br />

a reading exceeds a set limit, an alarm sounds. (See Setting Alarm<br />

Limits on page 41.)<br />

The Softkey Menu Bar displays the current functions for each of<br />

the four softkey buttons.<br />

14 N-595


Buttons, Indicators, and Alarms<br />

PLETH Display Information<br />

1 PLETH WAVEFORM Display 4<br />

PULSE RATE Display (BEATS<br />

PER MINUTE – BPM)<br />

2 SatSeconds Indicator 5 Softkey Menu Bar<br />

3<br />

%SPO2 Display (OXYGEN<br />

SATURATION PERCENTAGE)<br />

Figure 4: Pleth Display Information<br />

Description of PLETH View Information<br />

This section describes the displayed information when you use the<br />

PLETH view to monitor the patient.<br />

Note: The alarm limits for oxygen saturation and BPM are not<br />

shown on the PLETH view display, as they are in the BLIP<br />

view. Press the LIMITS softkey to view the currently set<br />

alarm limits when using the pleth view display.<br />

The PLETH WAVEFORM Display continuously updates and<br />

displays the patient’s pulse beat. The height of the waveform<br />

represents the relative strength of the patient’s pulse.<br />

The SatSeconds Indicator is an alarm management system. The<br />

clinician will determine if this feature is appropriate for the patient<br />

in the home. The SatSeconds symbol is only displayed if the feature<br />

is enabled.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 15


Buttons, Indicators, and Alarms<br />

The %SPO2 Display (OXYGEN SATURATION PERCENTAGE)<br />

reports the percentage of oxygen circulating in the patient’s blood<br />

system. You will see a decimal point after this value if the upper<br />

and/or the lower alarm limit has been changed since the monitor<br />

was last powered on.<br />

The PULSE RATE Display (BPM) represents the number of times<br />

per minute that the patient’s heart beats. You will see a decimal<br />

point after this value if the upper and/or the lower alarm limit has<br />

been changed since the monitor was last powered on.<br />

The Softkey Menu Bar displays the current functions for each of<br />

the four softkey buttons.<br />

Front Panel Symbol<br />

This symbol means the N-595 is not defibrillator proof. The symbol<br />

is located under the pulse oximetry cable connection.<br />

Rear Panel Components<br />

1<br />

Ground<br />

(Equipotential Terminal)<br />

4 Fuse Holder<br />

2 AC Power Connector 5 Supply Voltage Selector Switch<br />

3 Data Port Connector<br />

Figure 5: Rear Panel Components<br />

16 N-595


Buttons, Indicators, and Alarms<br />

Rear Panel Symbols<br />

This section describes the symbols located on the rear panel of the<br />

N-595 monitor.<br />

1<br />

Ground symbol<br />

(Equipotential Terminal)<br />

2 Data interface<br />

3<br />

Read the documentation before using<br />

the equipment.<br />

4 Manufacturing date of monitor<br />

5 Fuse replacement information<br />

Figure 6: Rear Panel Symbols<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 17


Buttons, Indicators, and Alarms<br />

Description of Audible Tones and Alarms<br />

Table 1 identifies the audible tones and alarms of the N-595.<br />

Table 1: Audible Tones and Alarms<br />

Function<br />

Alarm Silence Reminder<br />

Confirmation Tone<br />

Invalid Button Press<br />

Valid Button Press<br />

High Priority Alarm<br />

Medium Priority Alarm<br />

Low Priority Alarm<br />

Power-On Self-Test Pass<br />

Pulse Beep<br />

Volume Setting Tone<br />

Description<br />

Three beeps that sound approximately<br />

every three minutes.<br />

Three beeps sound to indicate that default<br />

settings have been saved or reset to factory<br />

defaults or trend data has been deleted.<br />

A short, low-pitched tone indicating that a<br />

button has been pressed that is not<br />

appropriate for the current state of the<br />

monitor.<br />

A short, medium-pitched tone indicating<br />

that an appropriate button has been<br />

pressed.<br />

A high-pitched, fast-pulsing tone<br />

indicating loss-of-pulse.<br />

A medium-pitched, pulsing tone indicating<br />

an SpO2 or pulse rate limit violation.<br />

A low-pitched, slow-pulsing tone<br />

indicating a sensor disconnect, low battery,<br />

or monitor failure.<br />

A one-second tone indicating that the<br />

N-595 has been turned on and has<br />

successfully completed the power-on selftest.<br />

A single beep sounds for each detected<br />

pulse. The pulse beep tone changes in pitch<br />

with changes in the patient’s oxygen<br />

saturation.<br />

A continuous tone that sounds as the alarm<br />

volume is adjusted.<br />

18 N-595


Setting Up the N-595 Monitor<br />

This section contains important information regarding the setup of<br />

the N-595 monitor. Be sure to read and follow all of the warnings<br />

and cautions in this section and elsewhere in this manual.<br />

Warnings inform you of situations and events you must avoid to<br />

prevent serious or fatal injury to either the patient or you.<br />

Cautions alert you to exercise care necessary for the safe and<br />

effective use of the N-595 monitor.<br />

WARNING: Locate the monitor near the patient in a position<br />

that ensures it cannot accidently fall on the patient. Failure to<br />

do so could result in patient injury.<br />

WARNING: Carefully route the oximetry cable between the<br />

patient and the monitor to reduce the possibility of patient<br />

entanglement or strangulation.<br />

WARNING: Ensure that the speaker is clear of any<br />

obstruction. Failure to do so could result in an inaudible alarm<br />

tone.<br />

WARNING: Make sure that you can hear an audible alarm<br />

from other rooms in the home, and when you are using noisy<br />

appliances, such as a dishwasher, clothes dryer, television, or<br />

radio. Failure to ensure that the alarm volume is appropriate<br />

for the environment may place the patient in danger. If you<br />

need the volume adjusted, immediately contact the clinician for<br />

help.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 19


Setting Up the N-595 Monitor<br />

WARNING: Do not connect the monitor to an electrical outlet<br />

controlled by a wall switch, because the monitor may be<br />

accidentally turned off.<br />

WARNING: To ensure accurate performance and prevent<br />

device failure, do not place the N-595 in extreme moisture<br />

environments, such as direct exposure to rain. Such exposure<br />

may cause inaccurate performance or device failure.<br />

WARNING: Inspect the N-595 monitor, sensor, cables, and<br />

connectors before each use. Do not use any equipment that<br />

appears damaged.<br />

WARNING: Do not lift the monitor by the oximetry cable or<br />

power cord because the cable or cord could disconnect from the<br />

monitor, causing the monitor to drop on the patient.<br />

WARNING: <strong>Use</strong> only the <strong>Nellcor</strong> pulse oximetry cable DOC-10<br />

with the N-595 monitor. <strong>Use</strong> of another pulse oximetry cable<br />

will have an adverse effect on performance. Do not attach any<br />

cable that is intended for computer use to the oximetry sensor<br />

port. Do not connect any device other than a <strong>Nellcor</strong>-approved<br />

sensor to the sensor connector.<br />

WARNING: The N-595 should not be used adjacent to or<br />

stacked with other equipment. If adjacent or stacked use is<br />

necessary, the N-595 should be observed to verify normal<br />

operation.<br />

20 N-595


Setting Up the N-595 Monitor<br />

Connecting the N-595 to AC Power<br />

Caution: The SUPPLY VOLTAGE SELECTOR switch must be<br />

set to the correct voltage (115V) to avoid equipment damage<br />

and ensure proper battery charging.<br />

Caution: <strong>Use</strong> only the hospital-grade power cord provided with<br />

the N-595 monitor.<br />

1. Set the SUPPLY VOLTAGE SELECTOR switch to the<br />

applicable voltage (115V).<br />

Figure 7: Voltage Selector and Power Connector<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 21


Setting Up the N-595 Monitor<br />

2. Plug the female connector end of the power cord into the N-595<br />

power connector on the rear of the monitor.<br />

Figure 8: Power Cord Connection<br />

WARNING: Do not plug the monitor into an electrical outlet<br />

controlled by a wall switch, because the monitor may be<br />

accidentally turned off.<br />

3. Plug the male connector of the power cord into a properly<br />

grounded AC outlet.<br />

4. Verify that the monitor’s AC POWER indicator is lit.<br />

Note: If the AC POWER indicator is not lit, do the following:<br />

• Ensure that the power cord is fully seated in the power connector<br />

on the rear of the monitor.<br />

• Ensure that the AC power outlet is functioning.<br />

• Check and confirm that the supply voltage selector switch is set<br />

for 115V.<br />

If the AC POWER indicator is still not lit, contact the clinician for<br />

further assistance.<br />

22 N-595


Oximetry Sensors<br />

Selecting an Oximetry Sensor<br />

WARNING: Before use, carefully read the directions for use<br />

that accompany the <strong>Nellcor</strong> oximetry sensor, including all<br />

warnings, cautions, and instructions.<br />

WARNING: Do not use a damaged sensor or pulse oximetry<br />

cable. Do not use a sensor with exposed optical components.<br />

WARNING: <strong>Use</strong> only <strong>Nellcor</strong>-approved OXIMAX sensors and<br />

pulse oximetry cable with this monitor. <strong>Use</strong> of other sensors or<br />

pulse oximetry cables may cause improper N-595 performance.<br />

WARNING: Do not attach any cable to the sensor port<br />

connector that is intended for computer use.<br />

WARNING: Tissue damage can be caused by incorrect<br />

application or duration of use of an oximetry sensor. Inspect the<br />

sensor site periodically as directed in the sensor directions for<br />

use.<br />

WARNING: Do not immerse or wet the sensor.<br />

WARNING: Do not lift the monitor by the sensor cable or<br />

power cord because the cable or cord could disconnect from the<br />

monitor, causing the monitor to drop on the patient.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 23


Oximetry Sensors<br />

WARNING: Pulse oximetry readings and pulse signals can be<br />

affected by certain environmental factors, oximetry sensor<br />

application errors, and certain patient conditions. Refer to the<br />

appropriate sections of this manual, including this chapter, for<br />

specific information.<br />

• Oximetry Sensors, page 23<br />

• Sensor Performance Considerations, page 49<br />

• EMI (Electromagnetic Interference), page 60<br />

Caution: The sensor disconnect error message and associated<br />

alarm indicate that the sensor is either disconnected or the<br />

wiring is faulty. If this error occurs, you should immediately<br />

check the sensor connection and, if necessary, replace the<br />

sensor, the pulse oximetry cable (DOC-10), or both.<br />

Contact your clinician before throwing away a used disposable<br />

sensor as patient data is recorded by some sensor models.<br />

The clinician will assist in the selection of a <strong>Nellcor</strong> sensor model<br />

that is appropriate for the patient, based in part on patient weight<br />

and activity level. Table 2 lists the available sensor models and<br />

patient weight ranges for which each sensor is appropriate.<br />

24 N-595


Table 2: <strong>Nellcor</strong> Oximetry Sensor Models<br />

and Patient Weights<br />

Oximetry Sensors<br />

Sensor<br />

Model<br />

Disposable Sensors<br />

Patient Weight in<br />

Pounds (lbs) and<br />

Kilograms (kg)<br />

OXIMAX TM oxygen sensor<br />

(Sterile, single-use only)<br />

OXIMAX MAX-FAST<br />

adhesive reflectance<br />

oxygen sensor<br />

(Sterile, single-use only)<br />

OXIMAX OxiCliq ® oxygen<br />

sensor<br />

(Sterile, single-use only)<br />

MAX-N<br />

MAX-I<br />

MAX-P<br />

MAX-A<br />

MAX-AL<br />

MAX-R<br />

MAX-FAST<br />

N<br />

I<br />

P<br />

A<br />

88 lbs<br />

(40 kg)<br />

6.6 to 44 lbs<br />

(3 to 20 kg)<br />

22 to 110 lbs<br />

(10 to 50 kg)<br />

>66 lbs<br />

(>30 kg)<br />

>66 lbs<br />

(>30 kg)<br />

>110 lbs<br />

(>50 kg)<br />

>22 lbs<br />

(>10 kg)<br />

88 lbs<br />

(40 kg)<br />

6.6 to 44 lbs<br />

(3 to 20 kg)<br />

22 to 110 lbs<br />

(10 to 50 kg)<br />

>66 lbs<br />

(>30 kg)<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 25


Oximetry Sensors<br />

Table 2: <strong>Nellcor</strong> Oximetry Sensor Models<br />

and Patient Weights (Continued)<br />

Sensor<br />

Model<br />

Reusable Sensors<br />

Patient Weight in<br />

Pounds (lbs) and<br />

Kilograms (kg)<br />

OXIMAX Oxiband ® oxygen<br />

sensor<br />

(Reusable with disposable<br />

nonsterile adhesive)<br />

OXI-A/N<br />

OXI-P/I<br />

88 lbs<br />

(40 kg)<br />

6.6 to 88 lbs<br />

(3 to 40 kg)<br />

OXIMAX Durasensor ®<br />

oxygen sensor<br />

(Reusable, nonsterile)<br />

OXIMAX Dura-Y ® multisite<br />

oxygen sensor<br />

(Reusable, nonsterile)<br />

For use with the Dura-Y<br />

sensor:<br />

• Ear clip (Reusable,<br />

nonsterile)<br />

• Pedi-Check ® pediatric<br />

spot-check clip (Reusable,<br />

nonsterile)<br />

DS-100A<br />

D-YS<br />

D-YSE<br />

D-YSPD<br />

>88 lbs<br />

(>40 kg)<br />

>2.2 lbs<br />

(>1 kg)<br />

>66 lbs<br />

(>30 kg)<br />

6.6 to 88 lbs<br />

(3 to 40 kg)<br />

Note: A DOC-10 pulse oximetry cable is always required to<br />

connect a sensor to the N-595 sensor port. (See Connecting a<br />

Sensor to the Monitor on page 31.)<br />

26 N-595


Using the Monitor<br />

Introduction<br />

This chapter contains the instructions for the routine operation of<br />

the N-595 monitor in a home-use environment. If you have any<br />

questions, or are unsure how to proceed, always contact the<br />

clinician for clarification.<br />

Note: Many instructions indicate that the monitor should be in the<br />

“normal monitoring mode.” Normal monitoring mode means that:<br />

• the monitor is turned on,<br />

• a sensor is connected to the monitor, via the DOC-10 Pulse<br />

Oximetry Cable,<br />

• the sensor is applied to the patient,<br />

• the patient’s %SpO2 (oxygen saturation percentage) and pulse<br />

rate readings (BPM) are being reported, and<br />

• no error conditions exist.<br />

Factory Default Settings<br />

Unless otherwise instructed by the clinician, you will use the preset<br />

factory default settings for the N-595 parameters. The clinician may<br />

override the factory default settings with patient-specific settings.<br />

Check with the clinician for more information.<br />

The table below lists each parameter, its range in value or setting,<br />

and the factory default setting. The parameters may be set on an<br />

individual basis, as instructed by the clinician, and these altered<br />

settings remain in effect until the N-595 is turned off. If you turn off<br />

your monitor, you must reenter the values provided by the clinician<br />

when the monitor is turned on again.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 27


Using the Monitor<br />

Caution: Each time the monitor is used, check the alarm limits<br />

to ensure that they are appropriate for the patient you are<br />

monitoring.<br />

Table 3: Parameter Factory Defaults and Ranges<br />

Parameter<br />

Ranges/Selections<br />

Adult/<br />

Pediatric<br />

Defaults<br />

Neonate<br />

Defaults<br />

Monitoring<br />

Mode<br />

Adult/Pediatric,<br />

Neonate<br />

Adult/<br />

Pediatric<br />

Neonate<br />

%SpO2 Upper<br />

Alarm Limit<br />

%SpO2 Lower<br />

Alarm Limit<br />

Pulse Rate Upper<br />

Alarm Limit<br />

Pulse Rate<br />

Lower Alarm<br />

Limit<br />

Alarm Silence<br />

Duration<br />

Lower Alarm Limit<br />

setting plus 1 to 100%<br />

20% to Upper Alarm<br />

Limit setting minus 1<br />

Lower Alarm Limit<br />

setting plus 1 to 250<br />

bpm.<br />

30 beats per minute<br />

(BPM) to Upper<br />

Alarm Limit setting<br />

minus 1<br />

Alarms 30, 60, 90,<br />

120 seconds<br />

Alarms Allow Off –<br />

Yes/No<br />

100% 95%<br />

85% 80%<br />

170 bpm 190 bpm<br />

40 bpm 90 bpm<br />

60 seconds 60 seconds<br />

Yes Yes<br />

Off Reminder –<br />

Yes/No<br />

Yes<br />

Yes<br />

Alarm Volume 1 to 10 7 7<br />

Default Display<br />

Format<br />

Pleth, Blip Pleth Pleth<br />

Display Contrast Low to High Medium Medium<br />

28 N-595


Using the Monitor<br />

Table 3: Parameter Factory Defaults and Ranges<br />

Parameter<br />

Ranges/Selections<br />

Adult/<br />

Pediatric<br />

Defaults<br />

Neonate<br />

Defaults<br />

Language<br />

English, French,<br />

German, Dutch,<br />

Portuguese, Spanish,<br />

Italian, Swedish<br />

English<br />

English<br />

Limits Adult, Neonate Adult Neonate<br />

Pulse Beep<br />

Volume<br />

0 to 10 4 4<br />

SatSeconds Off, 10, 25, 50, 100 Off Off<br />

Sensor Messages<br />

Enabled?<br />

Yes, No Yes Yes<br />

Turning On the Monitor<br />

Before using the N-595 to monitor the patient, verify that the<br />

monitor is working properly and is safe to use. Each time the<br />

monitor is turned on, it conducts a series of internal checks to verify<br />

proper operation, as described in the following section.<br />

Caution: If any indicator or display element does not light<br />

when the monitor is turned on, do not use the monitor. Instead,<br />

contact the clinician to report the problem.<br />

Caution: If the monitor speaker does not sound a one-second<br />

tone shortly after the power comes on, do not use the monitor.<br />

Instead, contact the clinician to report the problem.<br />

1. Turn on the N-595 by pressing the POWER ON/OFF button.<br />

2. Ensure that all of the front panel indicators illuminate.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 29


Using the Monitor<br />

3. Once the display test portion of power-on sequence is complete,<br />

the N-595 software version is displayed for approximately five<br />

seconds.<br />

4. If the N-595 detects an internal problem during the internal<br />

check, an alarm tone sounds and the monitor displays the letters<br />

“EEE” followed by an error code number, similar to the<br />

example below. If an error code is displayed, contact the<br />

clinician immediately to report that the monitor is<br />

malfunctioning.<br />

5. Upon successful completion of the internal check, the N-595<br />

sounds a one-second tone indicating that the monitor has passed<br />

the test.<br />

Caution: If you do not hear the one-second POST pass tone, do<br />

not use the monitor. Instead, contact the clinician to report the<br />

problem.<br />

Caution: Do not place objects in front of the monitor’s speaker.<br />

Doing so could prevent you from hearing an audible alarm<br />

while monitoring the patient.<br />

30 N-595


Using the Monitor<br />

Following successful completion of the self test, the monitor will<br />

immediately move into the patient monitoring mode. If there is no<br />

sensor connected to the monitor, or if the connected sensor is not<br />

applied to the patient, the monitor will not display readings for<br />

%SpO2 or pulse rate.<br />

If you have a sensor connected to the monitor and properly applied<br />

to the patient before the completion of the internal check, the<br />

monitor will begin searching for the pulse. Upon successfully<br />

detecting a pulse, the monitor will begin displaying the %SpO2 and<br />

pulse rate.<br />

Connecting a Sensor to the Monitor<br />

A <strong>Nellcor</strong> pulse oximetry cable, model DOC-10, must always be<br />

used to connect a sensor to the monitor. Refer to the directions for<br />

use accompanying the DOC-10 cable for additional information.<br />

Connect the DOC-10 cable to the monitor and plug the sensor into<br />

the DOC-10 cable, as instructed below.<br />

1. Connect the DOC-10 pulse oximetry cable to the oximetry<br />

sensor port located on the front panel of the monitor.<br />

2. Open the plastic latch at the opposite end of the cable and, with<br />

NELLCOR facing up on the sensor connector, plug the sensor<br />

and the DOC-10 cable together. Snap the plastic latch down<br />

over the connectors.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 31


Using the Monitor<br />

The monitor briefly displays the model name of the sensor.<br />

Figure 9: Connecting Sensor and DOC-10 Cable<br />

3. Apply the sensor to the patient, as instructed by the clinician.<br />

Be sure to also read the directions for use accompanying the<br />

sensor.<br />

4. The N-595 searches for a valid pulse, indicated by the lighted<br />

pulse search indicator.<br />

5. When a valid pulse is detected, the monitor enters the<br />

monitoring mode and displays the patient readings (%SpO2 and<br />

pulse rate).<br />

6. Look for movement of the blip bar or the pleth waveform as an<br />

indication that the monitor is displaying real-time data. Listen<br />

for the pulse beep tone.<br />

32 N-595


Using the Monitor<br />

If the pulse tone does not sound with each pulse, it is an<br />

indication that the pulse beep volume is set to zero, or that the<br />

speaker is malfunctioning, or that the pulse signal is corrupted.<br />

See Setting the Pulse Beep Volume on page 34.<br />

Note: If the sensor is not applied to the patient, or it is improperly<br />

applied to the patient, the monitor may display the following<br />

message.<br />

Selecting the BLIP View<br />

The BLIP view displays %SpO2, pulse rate, blip bar, and alarm<br />

limits in a larger format for easier viewing. It is better suited for<br />

viewing patient data in the home environment than the factory<br />

default PLETH view. (See Description of BLIP Display Information<br />

on page 13 for further details regarding the blip display.)<br />

With the monitor in the normal monitoring mode:<br />

1. Press the SETUP softkey.<br />

2. Press the VIEW softkey.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 33


Using the Monitor<br />

3. Press the BLIP softkey.<br />

Setting the Pulse Beep Volume<br />

After the monitor begins reporting valid %SpO2 and pulse rate<br />

readings, you may adjust the pulse beep volume up or down.<br />

Press and hold the ADJUST UP or ADJUST DOWN button to<br />

increase or to decrease pulse beep volume.<br />

Setting the Alarm Volume<br />

If the volume of the audible alarm function is too soft or too loud,<br />

contact the clinician for assistance.<br />

WARNING: Make sure that you can hear an audible alarm<br />

from other rooms in the home, and when you are using noisy<br />

appliances, such as a dishwasher, clothes dryer, television, or<br />

radio. Failure to ensure that the alarm volume is appropriate<br />

for the environment may place the patient in danger. If you<br />

need the volume adjusted, immediately contact the clinician for<br />

help.<br />

Turning the Display Backlight Off or On<br />

After you power on the monitor, the display backlight will be on.<br />

To turn the backlight off, press the LIGHT softkey.<br />

When the backlight is off, any one of the following events will turn<br />

on the backlight:<br />

• you press one of the softkeys<br />

• you press the CONTRAST button<br />

• you press the ALARM SILENCE button<br />

• the monitor detects an alarm condition<br />

34 N-595


Using the Monitor<br />

Adjusting Display Contrast<br />

You can adjust the display contrast to improve readability of the<br />

display.<br />

1. Press the CONTRAST button, located to the right of the<br />

softkeys.<br />

2. Press the ADJUST UP or ADJUST DOWN button until the<br />

desired contrast is obtained.<br />

3. Press the CONTRAST button to exit.<br />

Setting the Date and Time<br />

With the monitor in the normal monitoring mode:<br />

1. Press the SETUP softkey.<br />

2. Press the NEXT softkey.<br />

3. Press the CLOCK softkey.<br />

4. Press the SET softkey.<br />

5. Press the SELECT softkey to select:<br />

TIME HOURS: MINUTES : SECONDS (for example, 6:46:05)<br />

DATE DAY - MONTH - YEAR (for example, 30-AUG-01)<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 35


Using the Monitor<br />

6. <strong>Use</strong> the ADJUST UP or ADJUST DOWN buttons to change the<br />

selected value.<br />

7. Press the EXIT softkey.<br />

Adult-Pediatric and Neonatal Settings<br />

The factory default patient monitoring mode is ADULT-<br />

PEDIATRIC, which uses upper and lower alarm limits for oxygen<br />

saturation and pulse rate that are typically appropriate for adult and<br />

pediatric patients. If you are monitoring a neonate or infant, you<br />

can change to the neonatal monitoring mode by pressing the<br />

LIMITS softkey and selecting NEO. The upper and lower limits for<br />

monitoring a neonate or infant differ from those for an adult or a<br />

pediatric patient.<br />

If you modify the default value(s) of alarm limits in either the adult<br />

or neonate monitoring mode, the change will remain in effect only<br />

until the monitor is turned off. You will need to reenter your limit<br />

changes each time you turn on the monitor.<br />

Caution: Each time the monitor is used, check the alarm limits<br />

and the monitoring mode to ensure that they are appropriate<br />

for the patient you are monitoring.<br />

The clinician will advise you as to whether or not you should use<br />

alarm limits other than the default values when monitoring the<br />

patient. If needed, the clinician can program the monitor to override<br />

the default limits, using instead the settings appropriate for the<br />

36 N-595


Using the Monitor<br />

patient’s needs. You can discuss this option with the clinician. Refer<br />

to Table 3 for the adult/pediatric and neonate factory default limit<br />

settings.<br />

Selecting the Monitoring Mode<br />

With the monitor in the normal monitoring mode:<br />

1. Press the LIMITS softkey.The alarm limits for the currently<br />

selected monitoring mode are displayed.<br />

or<br />

2. Press the ADULT or NEO softkey to select ADULT/PEDIATRIC<br />

limits or NEONATE/INFANT limits, respectively, based on the<br />

patient type you are monitoring.<br />

If the NEO mode is selected, NEO will appear in the lower right<br />

of the display and will be visible at the patient monitoring<br />

screen.<br />

3. Press the SELECT softkey as needed to select the parameter to<br />

be adjusted.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 37


Using the Monitor<br />

4. <strong>Use</strong> the ADJUST UP or ADJUST DOWN button to increase or<br />

decrease the selected limit settings.<br />

5. Repeat steps 3 and 4 as necessary to complete the ALARM<br />

LIMITS setup.<br />

6. To accept the changes, let the display time out or press the EXIT<br />

softkey to exit the display and return to normal monitoring.<br />

Note: Remember that if you require the NEONATE/INFANT<br />

monitoring mode for the patient, you must reselect this<br />

mode each time you power on the monitor. Otherwise,<br />

the default monitoring mode (ADULT/PEDIATRIC) will<br />

be in effect. The clinician can change the power-on<br />

default to NEONATE if required.<br />

Setting Alarm Limits<br />

The ALARM LIMIT display allows you to adjust the upper and lower<br />

saturation and pulse rate limits.<br />

The ALARM LIMIT display includes the alarm limit table and the<br />

current measured %SpO2 and pulse rate. The title of the alarm limit<br />

table indicates whether the instrument is in ADULT or NEONATE<br />

monitoring mode. A decimal point after the displayed %SpO2 or<br />

pulse rate values indicate that the respective alarm limits have been<br />

changed from the power-on defaults.<br />

With the monitor in the normal monitoring mode:<br />

1. Press the LIMITS softkey. The alarm limits for the current<br />

monitoring mode are displayed.<br />

38 N-595


Using the Monitor<br />

or<br />

2. If necessary, press the ADULT or NEO softkey to change the<br />

Adult-Pediatric or Neonatal alarm limits screen.<br />

3. Press the SELECT softkey as needed to select the parameter to<br />

be adjusted.<br />

4. <strong>Use</strong> the ADJUST UP or ADJUST DOWN buttons to increase or<br />

decrease the selected limit parameter.<br />

5. Repeat steps 3, 4, and 5 as necessary to complete the alarm<br />

limits setup.<br />

6. To accept the changes, let the display time out or press the EXIT<br />

softkey to exit the display and return to normal monitoring.<br />

Note: Limit changes, as well as the selection of the NEONATAL<br />

monitoring mode, will only be in effect as long as the<br />

monitor remains turned on. When you turn the monitor off<br />

and back on, the factory default limits will again be in effect.<br />

The clinician may set up the monitor to always use settings other<br />

than the factory default values, based on the needs of the patient.<br />

These alternate settings are referred to as “institutional settings”<br />

and if the clinician programs them in the system, the monitor will<br />

use these as the power-up parameters in place of the factory default<br />

parameter values.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 39


Using the Monitor<br />

Alarm Limit Changed Indicator<br />

Alarm limits that have been changed from the factory default<br />

settings are identified by a decimal point after the displayed reading<br />

(%SPO2 or BPM). The changed parameter is also identified by a<br />

decimal point on the alarm limits screen.<br />

Sensor Messages<br />

The N-595 monitor suggests possible solutions for sensor<br />

placement when the monitor is unable to report the patient’s oxygen<br />

saturation. The monitor will display sensor messages, based on the<br />

type of sensor in use, that suggest actions to resolve the problem.<br />

You can enable or disable the sensor messages feature. The default<br />

for this feature is “enabled.”<br />

Condition messages are followed by action messages. For example,<br />

up to three condition messages may be displayed in priority order,<br />

with the highest priority displayed on top.<br />

Remove the condition display by pressing the EXIT softkey. Once<br />

exited, the condition display will not return until a new condition<br />

occurs.<br />

40 N-595


Using the Monitor<br />

If you press the HELP softkey from the condition message display,<br />

the action messages for the reported condition(s) are displayed. Up<br />

to five action messages may be displayed. Press NEXT, BACK, and<br />

EXIT softkeys to navigate through multiple screens that may be<br />

required to display all of the action messages.<br />

Sensor Message Setup<br />

<strong>Use</strong> this procedure to enable or disable the advanced sensor<br />

message feature. If you disable this feature, neither POOR SIGNAL<br />

CONDITION nor SUGGESTED ACTION will be displayed.<br />

With the monitor in the normal monitoring mode:<br />

Press the SETUP softkey.<br />

1. Press the SENSOR softkey.<br />

2. Press the MSG softkey.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 41


Using the Monitor<br />

3. Press the ADJUST UP or ADJUST DOWN button to toggle the<br />

ENABLE message from YES to NO.<br />

4. Press the EXIT softkey.<br />

Selecting the Display Language<br />

The N-595 can be programmed to display information in one of<br />

eight languages. The languages available are ENGLISH,<br />

FRANCAIS (French), DEUTSCH (German), ITALIANO (Italian),<br />

ESPANOL (Spanish), NEDERLANDS (Dutch), PORT (Portuguese)<br />

and SVERIGE (Swedish). Consult with the clinician before<br />

attempting to change the displayed language.<br />

Note: When you turn the monitor off and back on, the factory<br />

default language, English, will again be in use. The clinician<br />

can program the monitor for a different default language, if<br />

appropriate.<br />

With the monitor in the normal monitoring mode:<br />

1. Press the SETUP softkey.<br />

2. Press the NEXT softkey.<br />

3. Press the LANG softkey.<br />

42 N-595


Using the Monitor<br />

<strong>Use</strong> the ADJUST UP or ADJUST DOWN buttons to select the<br />

desired language.<br />

4. Press the EXIT softkey.<br />

Patient Trend Data<br />

The N-595 stores patient pulse and %SpO2 readings in memory,<br />

creating a patient trend data history that can be reviewed at any<br />

time by the clinician. The data are reviewed using the N-595<br />

software.<br />

Caution: Contact your clinician before throwing away a used<br />

disposable sensor as patient data is recorded by some sensor<br />

models.<br />

If it is necessary for you to access the patient data stored in the<br />

monitor, or the event data stored in the sensor, the clinician will<br />

provide instructions for accessing and viewing this data.<br />

Nurse Call Feature<br />

The N-595 has a feature called NURSE CALL. This feature is<br />

designed to assist qualified personnel in hospitals or similar health<br />

care centers. The nurse call mode, shown as NCALL, is an option<br />

accessed in the SETUP menu. This will not function in the home<br />

use environment. If you should enter the nurse call setup mode by<br />

accident, simply press the EXIT softkey to return to the main<br />

SETUP menu.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 43


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Prompt and Error Messages<br />

Introduction<br />

Prompt and error messages are displayed in the area normally<br />

reserved for softkey labels. Prompt messages prompt you for a<br />

response, while error messages provide information to you. The<br />

figures below provide an example of a prompt and an error message<br />

respectively.<br />

Managing Prompt and Error Messages<br />

<strong>Use</strong> Table 4 and Table 5 to determine what causes a specific<br />

message to be displayed, and how you can clear it. In these tables,<br />

the time-out value is the maximum time that the particular message<br />

will remain on the display. If the time-out is “None,” the message<br />

will remain on the display until you change the condition, by<br />

responding to the prompt (prompt message), by resolving the error<br />

condition (error message), or by pressing the ALARM SILENCE key<br />

(prompt or error message).<br />

Messages are prioritized so that more important messages will<br />

overwrite lower priority messages. Messages of the same priority<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 45


Prompt and Error Messages<br />

will be displayed in order of occurrence. For multiple messages,<br />

lower priority messages will be displayed when higher priority<br />

conditions are cleared.<br />

Table 4: Error Message<br />

Message<br />

Timeout<br />

(sec.)<br />

When Displayed<br />

How Cleared/<br />

Action<br />

CLOCK SETTING<br />

LOST<br />

None<br />

The N-595 detects<br />

that the real time<br />

clock has stopped<br />

running. This will<br />

occur when both<br />

battery and AC<br />

power are lost.<br />

Turn the monitor<br />

off and back on<br />

again. Reenter date<br />

and time.<br />

DEFAULTS LOST None The N-595 detects<br />

that power-on<br />

default settings<br />

have been lost.<br />

LOW BATTERY None The monitor is on<br />

battery power and<br />

the battery charge is<br />

low.<br />

SENSOR OFF None Sensor is not<br />

properly attached to<br />

the patient.<br />

Turn the monitor<br />

off and back on<br />

again. Verify<br />

monitor settings<br />

before using<br />

monitor.<br />

Connect the<br />

monitor to AC<br />

power to recharge<br />

the battery.<br />

Acknowledge the<br />

LOW BATTERY<br />

error by pressing<br />

the ALARM<br />

SILENCE button.<br />

When the sensor is<br />

reapplied to the<br />

patient or when the<br />

SENSOR OFF<br />

message is<br />

acknowledged by<br />

pressing the ALARM<br />

SILENCE button.<br />

SENSOR<br />

DISCONNECTED<br />

None<br />

The sensor is<br />

disconnected from<br />

the monitor.<br />

When the sensor is<br />

reconnected or<br />

when the sensor<br />

disconnection is<br />

acknowledged by<br />

pressing the ALARM<br />

SILENCE button.<br />

46 N-595


Prompt and Error Messages<br />

Table 5: Prompt Messages<br />

Message<br />

Timeout<br />

(sec.)<br />

When Displayed<br />

How Cleared<br />

SENSOR TYPE 5 First message<br />

displayed when a<br />

sensor is connected to<br />

the monitor.<br />

Time-out<br />

DATA IN<br />

SENSOR<br />

DELETE<br />

TRENDS?<br />

5 A sensor containing<br />

data is connected to<br />

the monitor.<br />

10 You attempt to delete<br />

trend data from<br />

memory by pressing<br />

the DELETE softkey<br />

in the TREND menu.<br />

On time-out, sensor<br />

disconnect, or<br />

pressing the<br />

ALARM SILENCE<br />

button, whichever<br />

comes first.<br />

After you respond<br />

(YES or NO) to the<br />

prompt.<br />

READING<br />

TRENDS. . .<br />

None<br />

The N-595 needs<br />

more than 4 to 6<br />

seconds to retrieve<br />

trend data from<br />

memory.<br />

When sensor data is<br />

completely<br />

retrieved or ABORT<br />

is selected.<br />

DATA TYPE<br />

EVENT/<br />

SPO2+BPM<br />

DATA TYPE:<br />

EVENT/SPO2<br />

5 A blank event sensor<br />

is connected to a<br />

monitor with event<br />

data type set to<br />

SPO2+BPM.<br />

5 A blank event sensor<br />

is connected to a<br />

monitor with event<br />

data type set to SPO2.<br />

On time-out, sensor<br />

disconnect, or<br />

pressing the<br />

ALARM SILENCE<br />

button, whichever<br />

comes first.<br />

On time-out, sensor<br />

disconnect, or<br />

pressing the<br />

ALARM SILENCE<br />

button, whichever<br />

comes first.<br />

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Performance Considerations<br />

Sensor Performance Considerations<br />

Certain patient conditions and environmental factors can adversely<br />

affect the quality of the patient’s readings, and may result in<br />

loss-of-pulse signal. The clinician will assess the patient for these<br />

conditions.<br />

WARNING: Pulse oximetry readings and pulse signals can be<br />

affected by certain environmental conditions, sensor<br />

application errors, and certain patient conditions. Refer to the<br />

appropriate sections of this manual, including this chapter, for<br />

specific information:<br />

• Oximetry Sensors, page 23<br />

• Sensor Performance Considerations, page 49<br />

•EMI (Electromagnetic Interference), page 60<br />

WARNING: Tissue damage can be caused by incorrect<br />

application or inappropriate duration of use of an oximetry<br />

sensor. Inspect the sensor site as directed in the sensor<br />

directions for use.<br />

WARNING: Ensure that the speaker is clear of any<br />

obstruction. Failure to do so could result in an inaudible alarm<br />

tone.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 49


Performance Considerations<br />

WARNING: Make sure that you can hear an audible alarm<br />

from other rooms in the home, and when you are using noisy<br />

appliances, such as a dishwasher, clothes dryer, television, or<br />

radio. Failure to ensure that the alarm volume is appropriate<br />

for the environment may place the patient in danger. If you<br />

need the volume adjusted, immediately contact the clinician for<br />

help.<br />

Caution: <strong>Use</strong> only <strong>Nellcor</strong>-approved <strong>OxiMax</strong> oximetry sensors<br />

and pulse oximetry cables.<br />

One or more of the following environmental factors or patient<br />

conditions can cause inaccurate measurements:<br />

• incorrect application of the sensor<br />

• placement of the sensor on an extremity with a blood pressure<br />

cuff, arterial catheter, or intravascular line<br />

• ambient light, such as a lamp at the patient’s bedside<br />

• prolonged and/or excessive patient movement<br />

• intravascular dyes or externally applied coloring, such as nail<br />

polish or pigmented cream<br />

• failure to cover the sensor site with opaque material in high<br />

ambient light conditions<br />

One or more of the following environmental factors or patient<br />

conditions can cause loss-of-pulse signal:<br />

• sensor is too tightly wrapped around the patient’s digit or other<br />

extremity<br />

• an inflated blood pressure cuff on the same extremity as the one<br />

with the sensor attached<br />

• an arterial occlusion (blocked artery) proximal to the sensor<br />

• poor peripheral profusion (circulation)<br />

50 N-595


Performance Considerations<br />

If patient movement presents a problem, under the guidance of the<br />

clinician, you may try one or more of the following remedies to<br />

correct the problem:<br />

• verify that the sensor is properly and securely applied<br />

• move the sensor to a less active site<br />

• use an adhesive sensor that tolerates some patient motion<br />

• use a new sensor with fresh adhesive backing<br />

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Battery Operation<br />

Operating on Battery Power<br />

The N-595 monitor has an internal battery that may be used to<br />

power the monitor during transport or when AC power is not<br />

available. A new, fully charged battery will provide at least 2 hours<br />

of monitoring time under the following conditions:<br />

• no audible alarms sound<br />

• no analog or serial output devices are attached to the N-595<br />

The monitor cannot operate with a fully discharged battery. Before<br />

attempting to turn on an N-595 monitor whose battery charge has<br />

been completely depleted, first plug the monitor into an electrical<br />

outlet (AC power) and allow the battery to charge for a few<br />

minutes. When the battery achieves a nominal charge, the monitor<br />

may then be powered on and operated using AC power only.<br />

Automatic Shutdown to Conserve Battery<br />

If you operate the monitor using the battery, the monitor will<br />

automatically shut down to conserve the battery when all of the<br />

three following conditions are present for 15 minutes:<br />

• no buttons have been pressed<br />

• no pulse has been detected (for example, no patient is connected<br />

to the sensor or the sensor is disconnected from the monitor)<br />

• no alarms are present (other than low battery or a noncorrectable<br />

error)<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 53


Battery Operation<br />

Caution: Do not use the N-595 monitor with battery power<br />

unless instructed to do so by the clinician. It is recommended<br />

that the N-595 monitor remain plugged into an AC power<br />

outlet.<br />

Note: Whenever the monitor is connected to AC power, the battery<br />

is being charged. Therefore, it is recommended that the<br />

monitor remain connected to AC power when not in use.<br />

This will ensure a fully charged battery whenever it is<br />

needed.<br />

Recharging the Battery<br />

To charge a low or dead battery, connect the monitor to an electrical<br />

outlet (AC power). Fourteen hours of charging are required to fully<br />

charge a dead battery if the monitor remains off. A full charge of a<br />

dead battery takes 18 hours if the monitor is in operation<br />

(monitoring a patient).<br />

As the battery is used and recharged over a period of time, the<br />

amount of time between the onset of the low battery alarm and the<br />

instrument shut-off may become shorter.<br />

Low Battery Indicator<br />

The LOW BATTERY indicator lights and a low priority alarm<br />

begins to sound when approximately 15 minutes of monitoring time<br />

are available on the existing battery charge.<br />

If the monitor is not on AC power, a low battery audible alarm can<br />

be canceled by pressing the ALARM SILENCE button. The low<br />

battery indicator and display screen message will continue to be<br />

displayed. Press the ALARM SILENCE button a second time to<br />

clear the message from the display. Plugging the monitor into AC<br />

power will silence the audible alarm, but the low battery indicator<br />

will stay lit as long as the battery is in the low voltage condition.<br />

After the 15-minute period of low battery condition, a high priority<br />

alarm will sound for about 10 seconds before the monitor shuts off.<br />

54 N-595


Battery Operation<br />

If the monitor backlight is turned off during a low battery condition,<br />

the backlight cannot be turned back on.<br />

Caution: If the N-595 monitor is to be stored for a period of two<br />

months or longer, contact the clinician for storage instructions.<br />

Recharge the battery when the battery has not been charged<br />

for two or more months.<br />

Note: If the AC voltage selector switch on the monitor rear panel<br />

does not match your AC voltage source, the monitor may run<br />

on battery power, even though it is plugged into AC power.<br />

This situation will eventually result in a low priority alarm<br />

and a lighted low battery indicator. Ensure that the switch<br />

setting matches your AC voltage (115V).<br />

Note: As the battery is used and recharged over a period of time,<br />

the amount of time between the onset of the low battery<br />

alarm and instrument shut-off may become shorter.<br />

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Troubleshooting<br />

WARNING: The cover should be removed only by qualified<br />

service personnel. There are no user-serviceable parts inside.<br />

Caution: Do not spray, pour, or spill any liquid on the N-595, its<br />

accessories, connectors, switches, or openings in the covers.<br />

Error Codes<br />

When the N-595 detects an error condition, it may display three<br />

letters, “EEE”, followed by an error code.<br />

When an error code is displayed, turn the instrument off and back<br />

on again. If the error code reappears, record it and notify the<br />

clinician immediately. You may also choose to contact your<br />

medical equipment dealer.<br />

Solving Problems<br />

Following is a list of possible problems and suggestions for<br />

correcting them. If you cannot correct a problem, immediately<br />

contact the clinician for further instructions. Do not attempt to<br />

monitor the patient using a monitor that fails the power-on test or is<br />

otherwise not operating properly.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 57


Troubleshooting<br />

1. There is no response to the POWER ON/OFF button.<br />

• Ensure that the supply voltage selector switch is set to the<br />

proper voltage (115V).<br />

• Verify that the wall outlet you are using to power the monitor<br />

is functioning.<br />

• If you are operating on battery power, check for a lighted<br />

LOW BATTERY indicator. If the LOW BATTERY indicator is<br />

lit, this indicates that the battery is discharged. To recharge<br />

the battery, see Recharging the Battery on page 54.<br />

• A fuse in the monitor may be blown. Notify the clinician.<br />

2. One or more display segments or front panel indicators do not<br />

light during the power-on self-test.<br />

• Do not use the N-595. Contact the clinician for further<br />

instructions.<br />

3. The PULSE SEARCH indicator is lit for more than 10 seconds<br />

after you begin monitoring the patient. (No readings are<br />

reported.)<br />

• Check the sensor site. The sensor may be applied too tightly<br />

to the patient’s digit. Reapply the sensor, as necessary.<br />

• The sensor may be on an extremity with a blood pressure<br />

cuff, an arterial catheter, or intravascular (I.V.) line. Contact<br />

the clinician for further guidance.<br />

• Excessive ambient light, such as a bedside lamp or direct<br />

sunlight, may interfere with measurements. Cover the site<br />

with an opaque blanket or towel.<br />

• Excessive patient motion may be preventing the N-595 from<br />

tracking the pulse. Keep the patient still, if possible. Verify<br />

that the sensor is securely applied, and replace it if necessary.<br />

Note: If patient motion is an ongoing issue, contact the<br />

clinician, who may be able to suggest the use of an<br />

alternate sensor site or a different sensor model.<br />

58 N-595


Troubleshooting<br />

• Contact the clinician to ensure you are using a sensor model<br />

appropriate for the patient you are monitoring.<br />

• Excessive electromagnetic interference may be preventing<br />

the N-595 from tracking the pulse. Remove the source of the<br />

interference. See EMI (Electromagnetic Interference) on<br />

page 60 for more information.<br />

4. The PULSE SEARCH indicator lights after some patient<br />

readings have been reported.<br />

• Check the patient.<br />

• Check the sensor site. The sensor may be applied too tightly<br />

to the patient’s digit. Reapply the sensor, as necessary.<br />

• The sensor may be on an extremity with a blood pressure<br />

cuff, an arterial catheter, or intravascular (I.V.) line. Contact<br />

the clinician for further guidance.<br />

• Excessive patient motion may be preventing the N-595 from<br />

tracking the pulse. Keep the patient still, if possible. Verify<br />

that the sensor is securely applied, and replace it if necessary.<br />

Note: If patient motion is an ongoing issue, contact the<br />

clinician, who may be able to suggest the use of an<br />

alternate sensor site or a different sensor model.<br />

• Contact the clinician to ensure you are using a sensor<br />

appropriate for the patient you are monitoring.<br />

5. The monitor displays three letters, “EEE”, followed by a<br />

number.<br />

• This is an error code. To confirm, turn the monitor off and<br />

back on again. If the error code occurs again, record the<br />

number and provide that information the clinician or your<br />

medical equipment dealer.<br />

6. LOW BATTERY message is displayed.<br />

• LOW BATTERY is displayed when the battery is discharged<br />

to a critically low level. Check to ensure that the voltage<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 59


Troubleshooting<br />

selector switch on the rear panel is set to 115V. Recharge the<br />

battery. (See Recharging the Battery on page 54.)<br />

• If you have recharged the battery for about ten minutes after<br />

a LOW BATTERY message was reported, turn on the<br />

monitor. If the same error message is still present, turn the<br />

monitor off and allow it continue recharging for another<br />

twenty minutes. Check for the error message again by<br />

turning on the monitor. If the error condition persists, notify<br />

the clinician immediately. Do not use the monitor on the<br />

patient.<br />

EMI (Electromagnetic Interference)<br />

Caution: This device has been tested and found to comply with<br />

the established limits for medical devices. These limits are<br />

designed to provide reasonable protection against harmful<br />

interference in a typical home-use environment.<br />

Because of the proliferation of radio-frequency transmitting<br />

equipment and other sources of electrical noise in the home-use<br />

environment (for example, cellular phones, mobile two-way radios,<br />

electrical appliances, and high-definition television), it is possible<br />

that high levels of such interference, due to proximity or strength of<br />

a source, may result in disruption of performance of this device.<br />

Disruption by EMI may be evidenced by erratic readings, cessation<br />

of operation, or other incorrect functioning of your monitor. If this<br />

occurs, the area around the monitor should be surveyed to<br />

determine the source of this disruption, and the following actions<br />

taken to eliminate the source:<br />

• Turn off the equipment off and on in the vicinity of the monitor<br />

to isolate the offending equipment.<br />

• Reorient or relocate the interfering equipment.<br />

• Increase the separation between the interfering equipment and<br />

the N-595 monitor.<br />

60 N-595


Troubleshooting<br />

The N-595 generates, uses, and can radiate radio frequency energy<br />

and, if not installed and used in accordance with the instructions in<br />

this manual, may cause interference with other devices in the<br />

vicinity.<br />

If assistance is required, contact the clinician.<br />

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Maintenance<br />

Service<br />

WARNING: Do not remove the cover on the monitor. You may<br />

cause the instrument malfunction and/or void any warranty.<br />

The N-595 requires no routine service or calibration other than<br />

changing the battery at least every 24 months. (The clinician will<br />

provide assistance if the battery requires replacement.)<br />

If service is necessary, inform the clinician, and contact your<br />

medical equipment dealer.<br />

Periodic Safety Checks<br />

It is recommended that the following checks be performed every<br />

24 months.<br />

• Inspect the equipment for mechanical and functional damage.<br />

• Inspect the safety-related labels for legibility.<br />

Cleaning<br />

Caution: Do not spray, pour, or spill any liquid on the N-595, its<br />

accessories, connectors, switches, or openings in the chassis.<br />

For surface-cleaning and disinfecting the monitor, follow the<br />

clinician’s instructions or:<br />

• The N-595 may be surface-cleaned by using a soft cloth<br />

dampened with either a commercial, nonabrasive cleaner or a<br />

solution of 70% alcohol in water, and lightly wiping the surfaces<br />

of the monitor.<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 63


Maintenance<br />

• The N-595 may be disinfected using a soft cloth saturated with a<br />

10% chlorine bleach solution, diluted in tap water.<br />

Before you clean an oximetry sensor, check the directions for use<br />

enclosed with the sensor for applicable cleaning instructions. If no<br />

cleaning instructions are present, the sensor is a disposable sensor<br />

and should be replaced rather than cleaned.<br />

The pulse oximetry cable may be surface-cleaned. Refer to the<br />

directions for use, enclosed with the cable, for applicable cleaning<br />

instructions.<br />

64 N-595


Specifications<br />

Performance<br />

The following technical specifications for the N-595 monitor are<br />

provided for reference. Please contact your clinician or medical<br />

equipment provider if you have questions.<br />

Table 6: Specifications<br />

Measurement Range<br />

SpO2 1% to 100%<br />

Pulse Rate<br />

20 beats per minute (bpm) to 250 bpm<br />

Perfusion Range 0.03% to 20%<br />

Oxygen Saturation<br />

Accuracy and Motion Tolerance<br />

Without Motion – Adults 1<br />

Without Motion – Neonate 1<br />

With Motion – Adults and<br />

Neonates 2<br />

Low Perfusion 3<br />

70 to 100% ± 2 digits<br />

70 to 100% ± 3 digits<br />

70 to 100% ± 3 digits<br />

70 to 100% ± 2 digits<br />

Pulse Rate<br />

Without Motion 1,2,3<br />

With Motion 2<br />

20 to 250 ± 3 digits<br />

normal physiologic range<br />

(55 - 125 bpm) ± 5 digits<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 65


Specifications<br />

Accuracy and Motion Tolerance<br />

Low Perfusion 3<br />

20 to 250 bpm ± 3 digits<br />

1<br />

Adult specifications are shown for OXIMAX MAX-A and MAX-N<br />

sensors with the N-595. Neonate specifications are shown for<br />

OXIMAX MAX-N sensors with the N-595. Saturation accuracy will<br />

vary by sensor type. Refer to the Sensor Accuracy Grid.<br />

2<br />

Applicability: OXIMAX MAX-A, MAX-AL, MAX-P, MAX-I, and<br />

MAX-N sensors.<br />

3<br />

Specification applies to monitor performance.<br />

Electrical<br />

Instrument<br />

Power<br />

Requirements<br />

Fuses<br />

rated at 108 to 132 volts AC (nominal 120 VAC)<br />

or 220 to 240 volts AC (nominal 230 VAC), 20<br />

volt/amps to be compliant with IEC 60601-1<br />

sub-clause 10.2.2<br />

qty 2, 0.5 A, 250 volts, slow-blow,<br />

IEC (5 x 20 mm)<br />

Battery<br />

The battery provides at least 2 hours of battery life when new and fully<br />

charged with no alarms, no serial data, no analog output, no nurse call<br />

output, with backlight on while using a pulse simulator set for<br />

224 bpm, high light and low modulation.<br />

Type<br />

Voltage<br />

Recharge<br />

Lead acid<br />

6 Volts DC<br />

• 14 hours with N-595 turned off<br />

• 18 hours with N-595 operating<br />

66 N-595


Specifications<br />

Battery<br />

Shelf Life<br />

Complies With<br />

• 2 months, new fully charged battery<br />

• After 2 months storage the N-595 will<br />

run for 50% of stated battery life<br />

91/157/EEC<br />

Sensors<br />

Wavelength<br />

and Power<br />

The wavelength range of the light emitted are near<br />

660 nm and 890 nm with the energy not exceeding<br />

15 mW.<br />

Environmental Conditions<br />

Operation<br />

Temperature<br />

Altitude<br />

Atmospheric Pressure<br />

Relative Humidity<br />

5 ºC to 40 ºC (41 ºF to 104 ºF)<br />

-390 m to 3,012 m<br />

(-1,280 ft. to 9,882 ft.)<br />

70 kPa to 106 kPa<br />

(20.6 in. Hg to 31.3 in. Hg)<br />

15% to 95% non-condensing to be<br />

compliant with IEC 60601-1,<br />

sub-clause 44.5<br />

Transport and Storage (not in shipping container)<br />

Temperature<br />

-20 ºC to 60 ºC<br />

(-4 ºF to 140 ºF)<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 67


Specifications<br />

Transport and Storage (not in shipping container)<br />

Altitude<br />

Atmospheric Pressure<br />

Relative Humidity<br />

-390 m to 5,574 m<br />

(-1,280 ft. to 18,288 ft.)<br />

50 kPa to 106 kPa<br />

(14.7 in. Hg to 31.3 in. Hg)<br />

15% to 95% non-condensing<br />

Transport and Storage (in shipping container)<br />

Temperature<br />

Altitude<br />

Atmospheric Pressure<br />

Relative Humidity<br />

-20 ºC to 70 ºC<br />

(-4 ºF to 158 ºF)<br />

-390 m to 5,574 m<br />

(-1,280 ft. to 18,288 ft.)<br />

50 kPa to 106 kPa<br />

(14.7 in. Hg to 31.3 in. Hg)<br />

15% to 95% non-condensing<br />

OXIMAX Sensor Power Dissipation<br />

OXIMAX MAX-N<br />

OXIMAX MAX-I<br />

OXIMAX MAX-P<br />

OXIMAX MAX-A<br />

OXIMAX MAX-AL<br />

OXIMAX MAX-R<br />

Sensor<br />

OXIMAX Oxiband OXI-A/N<br />

OXIMAX Oxiband OXI-P/I<br />

Dissipation<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

68 N-595


Specifications<br />

OXIMAX Sensor Power Dissipation<br />

Sensor<br />

OXIMAX Durasensor DS-100A<br />

OXIMAX OxiCliq P<br />

OXIMAX OxiCliq N<br />

OXIMAX OxiCliq I<br />

OXIMAX OxiCliq A<br />

OXIMAX Dura-Y D-YS<br />

OXIMAX MAX-FAST<br />

Dissipation<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

52.5 mW<br />

Physical Description<br />

Weight<br />

Dimensions<br />

5.8 lbs. (2.6 kg)<br />

3.3 in. x 10.4 in. x 6.8 in.<br />

(8.4 cm x 26.4 cm x 17.3 cm)<br />

Compliance<br />

Item<br />

Equipment classification<br />

Compliant With<br />

Safety Standards: IEC 6060-1 (same as<br />

EN60601-1), CSA 601.1,<br />

UL 2601-1, EN865, EN/IEC 60601-1-2<br />

(second edition)<br />

Type of protection<br />

Class 1 (on AC power)<br />

Internally powered (on battery power)<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 69


Specifications<br />

Item<br />

Compliant With<br />

Degree of protection<br />

Mode of operation<br />

N-595 resistant to liquid<br />

ingress<br />

Degree of safety in<br />

presence of a flammable<br />

anaesthetic<br />

Applied sensor label to<br />

indicate Type BF applied<br />

part<br />

Equipotential lug symbol to<br />

indicate a potential<br />

equalization conductor<br />

Attention symbol, consult<br />

accompanying<br />

documentation<br />

External case made with<br />

non-conductive plastic<br />

No holes in case top<br />

115/230 voltage selector<br />

switch<br />

Rigid case<br />

Case mechanically strong<br />

Case handle<br />

N-595 resistant to rough<br />

handling<br />

Type BF – Applied part<br />

Continuous<br />

IEC 60601-1, sub-class 44.6 for class<br />

IPX1 Drip-Proof equipment<br />

UL 2601-1, sub-clause 5.5, Not suitable<br />

IEC 60601-1 Symbol 2 of Table DII of<br />

Appendix D<br />

IEC 60601-1 Symbol 9 of Table DI of<br />

Appendix D<br />

IEC 60601-1 Symbols 14 of Table DI of<br />

Appendix D<br />

IEC 60601-1, sub-clause 16(a)<br />

IEC 60601-1, sub-clause 16(b)<br />

IEC 60601-1, sub-clause 16(f)<br />

IEC 60601-1, sub-clause 21(a)<br />

IEC 60601-1, sub-clause 21(b)<br />

IEC 60601-1, sub-clause 21(c)<br />

IEC 60601-1, sub-clause 21.6<br />

N-595 tip/tilt test IEC 60601-1, sub-clause 24.1<br />

N-595 resistant to liquid<br />

ingress due to spills<br />

IEC 60601-1, sub-clause 44.3 as<br />

modified by EN 865, clause 4<br />

70 N-595


Specifications<br />

Item<br />

Compliant With<br />

Environmental IEC 60601-1, sub-clause 44.5<br />

Cleaning IEC 60601-1, sub-clause 44.7<br />

Case surface made of nontoxic<br />

materials<br />

Case resistant to heat and<br />

fire<br />

N-595 power entry module<br />

fuse holder<br />

IEC 60601-1, sub-clause 48<br />

IEC 60601-1, sub-clause 59.2(b)<br />

IEC 60601-1, sub-clause 59.3<br />

N-595 exterior markings IEC 60601-1, sub-clause 6.1, 6.3, and<br />

6.4;EN 865, clause 6<br />

Front panel and case<br />

labeling<br />

N-595 button spacing ISO 7250<br />

Year of manufacture<br />

symbol<br />

Conductive coating and<br />

polymeric materials<br />

Operation during physical<br />

shock<br />

IEC 60878, EN 980, ISO 7000,<br />

EN 60417-1, EN 60417-2<br />

EN 980<br />

UL 2601-1, clause 55<br />

IEC 60068-2-27 at 100 g<br />

Operation during vibration IEC 60068-2-6 and IEC 60068-2-34<br />

Electromagnetic<br />

compatibility<br />

Radiated and conducted<br />

emissions<br />

IEC 60601-1, sub-clause 36,<br />

IEC/EN 60601-1-2 (second edition)<br />

EN 55011, Group 1, Class B<br />

Harmonic emissions IEC 61000-3-2<br />

Voltage fluctuations/flicker<br />

emissions<br />

Electrostatic discharge<br />

immunity<br />

IEC 61000-3-3<br />

EN 61000-4-2, level 3 table top<br />

equipment<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 71


Specifications<br />

Item<br />

Radiated radio-frequency<br />

electromagnetic field<br />

immunity<br />

Electrical fast transient/<br />

burst immunity<br />

Compliant With<br />

IEC 61000-4-3 at 3V/m<br />

IEC 61000-4-4, level 3<br />

Surge immunity IEC 61000-4-5, level 3;<br />

FDA Reviewer’s <strong>Guide</strong><br />

Conducted EMI<br />

susceptibility<br />

Power frequency magnetic<br />

fields<br />

Operation with line voltage<br />

variations<br />

Operation with electrical<br />

line voltage variations<br />

Radiated magnetic field<br />

emissions<br />

Magnetic field<br />

susceptibility<br />

Quasi-static electric field<br />

susceptibility<br />

IEC 61000-4-6 at 3 V/m<br />

IEC 61000-4-8 at 3 V/m<br />

IEC 61000-4-11 for Table 7<br />

FDA Reviewer’s <strong>Guide</strong><br />

RE 101/Army/7cm of MIL-STD-461E<br />

RS 101 in MIL-STD-461E<br />

FDA Reviewer’s <strong>Guide</strong><br />

72 N-595


Index<br />

Symbols<br />

%SpO2<br />

alarm limits, 13, 14, 38, 40<br />

default settings, 28<br />

definition, 2<br />

display, 13, 14, 15, 16, 31, 32, 33<br />

specifications, 65<br />

A<br />

AC power<br />

connector, 16, 21<br />

indicator, 11, 22<br />

accuracy grid<br />

sensor, 66<br />

action message, 40, 41<br />

adjust down button, 9, 10, 34, 35, 36, 38,<br />

39, 43<br />

adjust up button, 9, 10, 34, 35, 36, 38, 39,<br />

43<br />

adult softkey, 37, 39<br />

adult/pediatric mode, 36, 37, 38<br />

alarm management<br />

SatSeconds, 13, 15, 29<br />

alarm silence<br />

button, 9, 10, 34, 45, 47, 54<br />

duration, 10, 12, 28<br />

indicator, 11, 12<br />

reminder, 18, 28<br />

alarms<br />

condition, 34<br />

description, 18<br />

limit changed indicator, 40<br />

limits, 13, 14, 33, 36, 37, 38<br />

default settings, 28<br />

ranges, 28<br />

setting, 38, 39<br />

loss of pulse, 18<br />

low battery, 12, 18, 54, 55<br />

monitor failure, 18<br />

priorities, 18<br />

pulse rate, 18<br />

sensor disconnect, 18<br />

setting, 28<br />

SpO2, 18<br />

tones, 9<br />

volume, 4, 18, 19, 34, 50<br />

default setting, 28<br />

automatic shutdown, battery, 53<br />

B<br />

backlight<br />

monitor, 55<br />

turning on, 34<br />

battery<br />

alarm, 54<br />

automatic shutdown, 53<br />

charge, 53, 54, 66<br />

conservation, 53<br />

indicator, 11, 12, 54, 55, 58<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 73


Index<br />

low battery, 12, 18, 54, 55, 59, 60<br />

operation, 53<br />

recharging, 53, 54, 58, 66<br />

replacing, 63<br />

shelf life, 67<br />

specifications, 66<br />

beats per minute (see bpm)<br />

beep tone<br />

pulse, 18, 32<br />

default, 29<br />

volume, 33<br />

blip bar, 13, 14, 32, 33<br />

blip display, 13, 32<br />

selecting, 33<br />

blip softkey, 34<br />

bpm<br />

alarm limits, 1, 13, 14, 40<br />

default settings, 28<br />

definition, 2<br />

display, 1, 13, 14, 15, 16, 38<br />

specifications, 65<br />

buttons<br />

adjust down, 9, 10, 34, 35, 36, 38, 39,<br />

43<br />

adjust up, 9, 10, 34, 35, 36, 38, 39, 43<br />

alarm silence, 9, 10, 34, 45, 47, 54<br />

contrast, 9, 10, 34, 35<br />

front panel, 9<br />

power on/off, 9, 10, 29, 58<br />

softkeys, 9, 10, 33, 34<br />

C<br />

cable<br />

connector, 11<br />

DOC-10 cable, 26, 31, 32<br />

pulse oximetry, 26, 31, 32<br />

connecting sensor to, 32<br />

sensor, 2, 31<br />

cautions, 5, 24, 29<br />

definition, 5<br />

cleaning<br />

cables, 64<br />

monitor, 63<br />

sensor, 64<br />

clinician<br />

definition, 1<br />

role, 8<br />

clock setting lost, 46<br />

clock softkey, 35<br />

condition message, 40, 41<br />

connector<br />

AC power, 16, 21<br />

data port, 16<br />

ground, 16<br />

contrast<br />

button, 9, 10, 34, 35<br />

setting, 28, 35<br />

D<br />

data<br />

patient trend, 43<br />

data in sensor<br />

indicator, 11, 12<br />

data in sensor message, 47<br />

data interface symbol, 17<br />

data port<br />

connector, 16<br />

data type message, 47<br />

74 N-595


Index<br />

date<br />

setting the, 35<br />

decimal point, 38, 40<br />

default settings, 36, 39<br />

defaults lost message, 46<br />

delete trends message, 47<br />

display<br />

backlight, 34<br />

blip, 13, 32<br />

selecting view, 33<br />

bpm, 13, 14, 15, 16, 38<br />

contrast, 28, 35<br />

default, 28<br />

pleth, 15, 28, 32<br />

pulse rate, 13, 14, 15, 16, 33, 38<br />

disposable sensor, 25, 43<br />

DOC-10 cable, 31, 32<br />

connection, 11<br />

E<br />

EEE error code, 30, 57, 59<br />

electrical specifications, 66<br />

electromagnetic interference (EMI), 59,<br />

60<br />

environmental factors, 50<br />

environmental specifications, 67<br />

error code, 30, 45, 57, 59<br />

exit softkey, 36, 38, 39, 41, 43<br />

F<br />

front panel<br />

components, 11<br />

control buttons, 9, 10<br />

indicators, 11, 29, 58<br />

symbol, 16<br />

fuse, 58<br />

symbol, 17<br />

fuse holder, 16<br />

G<br />

ground connector, 16<br />

ground symbol, 17<br />

H<br />

help softkey, 41<br />

help, obtaining, 2<br />

home caregiver<br />

definition, 1<br />

I<br />

indicator<br />

AC power, 11, 22<br />

alarm silence, 11, 12<br />

data in sensor, 11, 12<br />

front panel, 29, 58<br />

low battery, 11, 12, 54, 55, 58<br />

motion, 11, 12<br />

pulse amplitude, 13, 14<br />

pulse search, 11, 12, 58, 59<br />

SatSeconds, 13, 15<br />

status, 9, 11<br />

L<br />

lang softkey, 42<br />

language<br />

default setting, 29<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 75


Index<br />

factory default, 42<br />

selecting display language, 42<br />

limits<br />

alarms, 33, 36, 37<br />

setting, 39<br />

default settings, 29<br />

limits softkey, 37, 38<br />

low battery indicator, 11, 12, 54, 55, 58<br />

low battery message, 46<br />

M<br />

manufacturing date symbol, 17<br />

menu<br />

softkey, 9, 13, 14, 15, 16<br />

message<br />

action, 40, 41<br />

clock setting lost, 46<br />

condition, 40, 41<br />

EEE, 30, 57, 59<br />

error, 45<br />

error table, 46<br />

low battery, 59, 60<br />

priority, 40, 45<br />

prompt, 45<br />

prompt table, 47<br />

sensor, 40<br />

default setting, 29, 40<br />

sensor disconnect, 24<br />

mode<br />

adult/pediatric, 37<br />

neonatal, 37<br />

monitor<br />

AC power and, 21<br />

advanced signal evaluation, 40, 41<br />

alarm limits<br />

%SpO2, 36<br />

setting, 38<br />

alarms<br />

limit changed indicator, 40<br />

backlight, 55<br />

battery<br />

charge, 54, 66<br />

low battery indicator, 54<br />

operation, 53<br />

recharging, 54<br />

blip display, 33<br />

connecting to AC power, 21<br />

contrast, 28<br />

date, 35<br />

date and time, setting, 35<br />

dimensions, 69<br />

disinfecting, 63<br />

display backlight, 34<br />

display contrast, 35<br />

display, default, 28<br />

error codes, 57<br />

factory default settings, 27–29, 37, 39<br />

front panel<br />

components, 11<br />

control buttons, 9, 10<br />

indicators, 11<br />

language<br />

selecting display language, 42<br />

messages, prompt and error, 45<br />

nurse call, 43<br />

pulse beep tone<br />

volume, setting, 34<br />

rear panel<br />

components, 16<br />

indicators, description, 17<br />

safety checks, 63<br />

76 N-595


Index<br />

sensors<br />

connecting to, 31<br />

service, 63<br />

specifications, 65<br />

supply voltage selector switch, 21<br />

surface cleaning, 63<br />

time, 35<br />

turning on, 29<br />

weight, 69<br />

monitoring mode<br />

adult/pediatric, 28, 36, 38<br />

default, 36<br />

neonatal, 28, 36, 38, 39<br />

normal, 1, 27, 31, 32, 35, 37, 38, 42<br />

selecting, 36, 37<br />

motion<br />

indicator, 11, 12<br />

problem with, 58, 59<br />

N<br />

neo softkey, 37, 39<br />

neonatal mode, 36, 37, 38, 39<br />

next softkey, 35, 42<br />

normal monitoring mode, 31, 32, 35, 37,<br />

38, 42<br />

definition, 1<br />

description, 27<br />

nurse call, 43<br />

O<br />

oxygen saturation<br />

alarm limits, 13, 14, 38, 40<br />

default settings, 28<br />

definition, 2<br />

display, 13, 14, 15, 16, 31, 32, 33<br />

specifications, 65<br />

P<br />

patient<br />

monitoring mode, 36, 37<br />

motion, 58, 59<br />

trend data, 43<br />

weight, 24, 25<br />

performance<br />

sensors, 49<br />

pleth display, 15, 28, 32<br />

power<br />

battery, 53<br />

electrical, 55<br />

specifications, 66<br />

power on/off button, 9, 10, 29, 58<br />

power-on self-test, 18, 57, 58<br />

prompt message, 45<br />

pulse amplitude<br />

definition, 2<br />

indicator, 13, 14<br />

pulse beep<br />

tone, 18, 32<br />

volume, 33, 34<br />

default, 29<br />

pulse oximeter<br />

definition, 2<br />

pulse oximetry<br />

cable, 31<br />

pulse rate<br />

alarm limits, 1, 13, 14, 40<br />

default settings, 28<br />

definition, 2<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 77


Index<br />

display, 1, 13, 14, 15, 16, 33, 38<br />

specifications, 65<br />

pulse search indicator, 11, 12, 58, 59<br />

R<br />

reading trends message, 47<br />

rear panel<br />

components, 16<br />

description, 17<br />

symbols, 17<br />

reusable sensor, 26<br />

S<br />

safety check, 63<br />

SatSeconds<br />

default setting, 29<br />

indicator, 13, 15<br />

select softkey, 35, 37, 39<br />

selector<br />

voltage, 21<br />

sensor<br />

accuracy grid, 66<br />

advanced signal evaluation, 40, 41<br />

application, 58, 59<br />

cable, 2, 31<br />

connecting to monitor, 31, 32<br />

data, 24<br />

definition, 2<br />

disconnect error, 24<br />

disposable, 24, 25, 43<br />

inaccurate measurements<br />

patient movement, 51<br />

message, 40<br />

default setting, 29, 40<br />

models, 25<br />

performance considerations, 49<br />

port, 11, 26<br />

reusable, 26<br />

selection, 23, 24, 25<br />

specifications, 67, 68<br />

sensor disconnected message, 46<br />

sensor off message, 46<br />

sensor type message, 47<br />

set softkey, 35<br />

setting<br />

alarm limits, 39<br />

contrast, 28<br />

date, 35<br />

institutional limits, 39<br />

language, 29<br />

limits, 29<br />

nurse call, 43<br />

pulse beep volume, 34<br />

time, 35<br />

setup softkey, 33, 35, 42<br />

softkey, 34<br />

adult, 37, 39<br />

blip, 34<br />

button, 9, 10<br />

clock, 35<br />

exit, 36, 38, 39, 41, 43<br />

help, 41<br />

labels, 45<br />

lang, 42<br />

limits, 37, 38<br />

menu bar, 9, 13, 14, 15, 16<br />

neo, 37, 39<br />

next, 35, 42<br />

select, 35, 37, 39<br />

78 N-595


Index<br />

set, 35<br />

setup, 33, 35, 42<br />

view, 33<br />

software version, 30<br />

speaker, 11, 29, 30<br />

specifications, 65–72, ??–72<br />

status indicators, 9, 11<br />

supply voltage selector, 21<br />

symbol<br />

front panel, 16<br />

symbols<br />

rear panel, 17<br />

T<br />

time<br />

setting the, 35<br />

tone<br />

audible, 9<br />

confirmation, 18<br />

invalid button press, 18<br />

POST, 18<br />

power-on self-test, 18, 29<br />

priority, 18<br />

pulse beep, 32<br />

valid button press, 18<br />

volume setting, 18<br />

tones, audible<br />

description, 18<br />

trend data, 43<br />

troubleshooting, 57<br />

V<br />

view softkey, 33<br />

voltage selector switch, 16, 21, 55, 58,<br />

59<br />

volume<br />

alarms, 4, 18, 19, 34, 50<br />

default setting, 28<br />

pulse beep, 34<br />

default, 29<br />

tones, 18<br />

W<br />

warnings, 3–4, 7, 19, 23, 49<br />

definition, 3<br />

waveform display, 15, 32<br />

weight<br />

monitor, 69<br />

<strong>Home</strong> <strong>Use</strong> <strong>Guide</strong> 79


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Tyco Healthcare Group LP<br />

<strong>Nellcor</strong> Puritan Bennett Division<br />

4280 Hacienda Drive<br />

Pleasanton, CA 94588 U.S.A.<br />

Telephone Toll Free 1.800.635.5267<br />

Authorized Representative<br />

Tyco Healthcare UK LTD<br />

154 Fareham Road<br />

Gosport PO13 0AS, U.K.<br />

Rx ONLY<br />

© 2003 <strong>Nellcor</strong> Puritan Bennett Inc. All rights reserved. 065867A-0103

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