N-560 Home Use Guide Feb 2005

This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 Canada. Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, OxiBand, Dura-Y, MAX-FAST, SatSeconds, PediCheck, Oxismart and OXIMAX are trademarks of Nellcor Puritan Bennett Inc. To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department, or your local representative. Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett. Covered by one or more of the following US patents and foreign equivalents: 4,802,486; 4,869,254; 4,928,692; 4,934,372; 4,960,126; 5,078,136; 5,485,847; 5,743,263; 5,865,736; 6,035,223; 6,298,252; 6,463,310; 6,591,123; 6,675,031; 6,708,049; 6,801,797; Re 35,122.

Contents Contents... i Figures... v Tables... vii Important Information... 1 Introduction ...1 Definitions ...1 Clinician ...1 Normal Monitoring Mode ...1 Oxygen Saturation ...2 Pulse Amplitude ...2 Pulse Oximeter ...2 Pulse Rate ...2 Sensor ...2 Site or Sensor Site ...3 If You Need Help ...3

Safety Information... 5 Warnings ...5 Cautions ...7 Notes ...7

Purpose of the N-560... 9

Purpose of the N-560 ...9 Role of the Clinician ...9

Buttons, Indicators, and Alarms... 11 Front Panel Control Buttons ...11 Function of Front Panel Control Buttons ...12 N-560 Home Use Guide

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Contents

Display Information ... 13 Description of Display Information ... 14 Front Panel Status Indicators and Components ... 15 Description of Status Indicators ... 16 Front Panel Symbol ... 18 Rear Panel Components ... 19 Rear Panel Symbols ... 20 Description of Audible Tones and Alarms ... 21

Setting Up the N-560... 23

Connecting the N-560 to AC Power ... 25

Oximetry Sensors... 27

Selecting an Oximetry Sensor ... 27

Using the N-560... 33

Introduction ... 33 Factory Default Settings ... 33 Turning On the N-560 ... 35 Connecting a Sensor to the N-560 ... 38 No Sensor Attached ... 40 Sensor Message ... 41 Setting the Pulse Beep Volume ... 42 Setting the Alarm Volume ... 42 Verify Patient Settings ... 43 Setting Alarm Limits ... 44 Setting SatSeconds Duration ... 47 Alarm Limit Changed Indicator ... 47 Patient Trend Data ... 48

Performance Considerations... 49

Sensor Performance Considerations ... 49 ii

Contents

Battery Operation... 53 Operating on Battery Power ...53 Automatic Shutdown to Conserve Battery ...53 Recharging the Battery ...54 Low Battery Indicator ...54

Troubleshooting... 57

Error Codes ...57 Solving Problems ...58 EMI (Electromagnetic Interference) ...61

Maintenance... 63

Service ...63 Periodic Safety Checks ...63 Cleaning ...64

Specifications... 65

Performance ...65 Electrical ...69 Environmental Conditions ...70 Physical Characteristics ...72 Compliance ...72

Index... 73

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Contents

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Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Figure 8:

N-560 Speaker ...6 Front Panel Control Buttons ...11 Display Information...13 Front Panel Status Indicators and Components...15 Rear Panel Components ...19 Rear Panel Symbols...20 AC Power Connection...25 Connecting Sensor and DOC-10 Cable ...39

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List of Figures

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Ta b l e s Table 1: Table 2: Table 3: Table 4: Table 5:

Audible Tones and Alarms...21 Nellcor Oximetry Sensor Models and Patient Weights ...29 Parameter Factory Defaults and Ranges...34 Error Codes...58 Tone Definition...66

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List of Tables

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Important Information Introduction

This manual is for the home caregiver - the person who provides care for a patient monitored by the N-560™ pulse oximeter in the home. As the home caregiver, it is important that you read this entire manual before you use the N-560. This manual contains important safety information and N-560 instructions. If you do not understand any part of this information, ask the clinician who will be monitoring and tracking the patient’s results to explain it to you. Definitions

Clinician In this manual, the term “clinician” means the trained healthcare professional who assists you with monitoring the patient and using the N-560 in your home. This person can be the doctor or nurse who is treating the patient, or some other trained healthcare professional.

Normal Monitoring Mode Normal monitoring mode means that: • the N-560 is turned on • a sensor is connected to the N-560 • the sensor is applied to the patient

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Important Information • the patient’s %SpO2 (oxygen saturation percentage) and pulse rate readings (BPM) are being reported on the monitor • no error conditions exist

Oxygen Saturation A measurement of the percentage of oxygen circulating in the patient’s blood. Oxygen saturation is also identified as %SpO2.

Pulse Amplitude The relative strength of the patient’s pulse. A higher pulse amplitude indicates a stronger pulse. A lower pulse amplitude indicates a weaker pulse.

Pulse Oximeter A medical device that measures a patient’s pulse rate and percent of oxygen saturation in the blood. The N-560 is a pulse oximeter.

Pulse Rate A measurement of the number of times the patient’s heart beats per minute. Pulse rate is also called beats per minute or BPM.

Sensor A sensor is an accessory used to collect and send patient information to the N-560. One end of the sensor is attached to the patient’s finger, toe, ear lobe, or forehead and the other end of the sensor connects to the monitor cable. The sensor provides

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Important Information measurement signals from which the pulse rate and percentage of oxygen in the blood are determined.

Site or Sensor Site The place on the patient where the sensor is attached. If You Need Help

Contact the clinician if you have any questions or concerns about using the N-560. If you believe the N-560 is not functioning properly, always notify the clinician, who may be able to correct the problem. If you require assistance in operating the equipment, and are unable to contact the clinician, call the 24-hour hotline of your medical equipment dealer. Keep the dealer’s business card with this manual. That card identifies the hotline number.

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Important Information

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Safety Information

Safety Information

Warnings Warnings in this manual are identified by the WARNING symbol shown above. Warnings alert you to potential serious outcomes (death, injury, or adverse events) to you or the patient. Contact the clinician if you have any questions regarding the warnings in this manual.

WARNING: Explosion hazard. Do not use the N-560 pulse oximeter in the presence of flammable anesthetics or gases. WARNING: Pulse oximetry readings and pulse signals can be affected by certain environmental conditions, oximetry sensor application errors, and certain patient conditions. Refer to the appropriate chapters of this manual, including this chapter, for specific information: • Oximetry Sensors on page 27 • Sensor Performance Considerations on page 49 • EMI (Electromagnetic Interference) on page 61 WARNING: The use of accessories, oximetry sensors, and cables other than those specified in this manual may result in inaccurate readings of the N-560. N-560 Home Use Guide

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Safety Information

WARNING: Do not lift the N-560 by the oximetry cable or power cord because the cable or cord could disconnect from the N-560, causing the N-560 to drop on the patient. WARNING: Make sure that the N-560 speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm tone. See Figure 1.

1 - Speaker Figure 1:

N-560 Speaker

WARNING: Make sure that you can hear an audible alarm from other rooms in the home, and when you are using noisy appliances, such as a dishwasher, clothes dryer, television, or radio. Failure to ensure that the alarm volume is appropriate for the environment may place the patient in danger. If you need assistance adjusting the volume, immediately contact the clinician for help.

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Safety Information

Cautions

Cautions are identified by the CAUTION symbol shown above. Cautions alert you to exercise care necessary for the safe and effective use of the N-560.

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Caution: The oximetry sensor off alarm indicates that the sensor is either disconnected or the wiring is faulty. Check the sensor connection and, if necessary, replace the sensor, pulse oximetry cable, or both. If necessary, contact the clinician for assistance. Notes

Notes are identified by the Note symbol shown above. Notes provide additional useful information.

Note: Sensor LED light emissions fall within Class I level,

according to IEC 60825-1:2001. No special safety precautions are required.

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Safety Information

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Purpose of the N-560 Purpose

of

the

N-560

WARNING: The N-560 is only a warning device. You must take action, as directed by the clinician, when an alarm occurs. The N-560 cannot act for you. WARNING: The N-560 and the oximetry sensor are prescription devices. Use only on the patient for whom prescribed and only as directed by the clinician.

Purpose of the N-560

The N-560 can be used for patients of all ages - infants, children, and adults. The clinician will assist you with the selection and use of the appropriate OXIMAX oximetry sensor, based on the size of the patient. (See Oximetry Sensors on page 27.) With active patients, single-patient-use sensors are a better choice for monitoring than reusable sensors. (See Patient Activity Level on page 28 for more information.) The N-560 continuously measures the patient’s pulse rate and the percentage of oxygen circulating in the blood. When either the patient’s pulse rate or the percentage of oxygen goes below or above a pre-set alarm limit, the N-560 warns you by sounding an alarm, lighting an indicator, or changing the number display from green to red. Role of the Clinician

The clinician is a trained health care professional who will:

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Purpose of the N-560 • order the N-560 for use in your home • set up the N-560 for you • assist you with monitoring the patient • review the monitored results and the patient’s condition • show you how to use the N-560 • select a sensor for use with the N-560 • show you how to respond to alarms • show you how to set the alarm limits • answer your questions about the N-560 • ensure that the N-560 is working correctly • check with you on a regular basis to make sure the N-560 is meeting your needs

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