N-20PA Portable Pulse Oximeter Operators Manual July 2001

Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588 USA Telephone Toll Free 1.800.NELLCOR Tyco Healthcare UK LTD Fareham Road Gosport PO13 0AS U.K. Tel: +44.1329.224000

Nellcor Puritan Bennett is a wholly owned subsidiary of Mallinckrodt Inc. Nellcor and Nellcor Puritan Bennett are trademarks of Mallinckrodt Inc. To obtain information about a warranty, if any, for this product, contact Mallinckrodt Technical Services or your local Mallinckrodt representative. Durasensor, Oxiband, Oxisensor II, OxiCliq, and Dura-Y are trademarks of Mallinckrodt Inc. Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643; 4,685,464; 4,700,708; and 4,770,179.

TABLE OF CONTENTS List of Figures List of Tables Table of Contents ... List of Figures ... List of Tables ... Safety Information ... Warnings ... Measurements ... Sensors ... Cautions ... Symbols ... Quick Guide to Operation ... Basic Operation... Features of the N-20PA ... N-20PA Overview... About this Manual... Setup ... Unpacking and Inspection... Testing... List of Components ... Optional Accessories... Components ... Setup ... Installing the Batteries... Installing the Protective Boot ... Setting the Clock... Loading Printer Paper ... Guide to Operation ... Basic Operation... Turning Beeper Off (Or On) ... Battery Operation ... Adult and Neonatal Modes ... Alarms ... Setting Alarm Limits ... Printer ...

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Contents Nellcor Sensors ... Selecting a Sensor... Cleaning and Reuse ... Performance Considerations ... Maintenance... Service ... Cleaning... Determining Software Version ... Obtaining Technical Assistance... Returning N-20PA... Principles of Operation... Oximetry Overview... Automatic Calibration ... Functional Versus Fractional Saturation ... Measured Versus Calculated Saturation... Troubleshooting ... Troubleshooting Guide ... Specifications ... Performance ... Alarms ... Factory Default Alarm Settings... Electrical ... Environmental ... Physical... Index ...

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Contents

LIST OF FIGURES Figure 1: N-20PA Front Panel ... Figure 2: N-20PA Rear Panel ... Figure 3: Installing Batteries ... Figure 4: Button Location for Setting Clock ... Figure 5: N-20PA Printer Overview ... Figure 6: Removing Paper Compartment Cover ... Figure 7: Loading Printer Paper ... Figure 8: Example of N-20PA Printout ... Figure 9: Oxyhemoglobin Dissociation Curve ... Figure 10: Removing Paper Access Cover ...

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LIST OF TABLES Table 1: Alarms Summary ... 21 Table 2: Default Alarm Limits... 25 Table 3: Nellcor Sensors ... 30

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SAFETY INFORMATION Warnings Cautions

WARNINGS WARNING: Oxygen vigorously accelerates combustion. Possible fire hazard when used with oxygen-administering equipment. Explosion hazard when used in the presence of flammable anesthetics. WARNING: Before use, read this manual, accessory directions for use, all precautionary information, and specifications. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: The N-20PA is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING: Shock hazard. Cover to be removed only by qualified service personnel. There are no user-serviceable parts inside. Measurements

WARNING: Do not use the N-20PA or oximetry sensors during magnetic resonance imaging (MRI) scanning. Conducted current could potentially cause burns. Also, the N-20PA may affect the MRI image, and the MRI unit may affect oximeter accuracy.

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Safety Information

WARNING: Inaccurate measurements may be caused by incorrect sensor application or use; significant levels of dysfunctional hemoglobin (e.g., carboxyhemoglobin or methemoglobin) or intravascular dyes such as indocyanine green or methylene blue; exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heat lamps, or direct sunlight; excessive movement; venous pulsations; electrosurgical interference; and placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. WARNING: Do not silence the audible alarm if patient safety could be compromised. WARNING: Check the audible alarm silence duration before silencing the audible alarm. WARNING: Each time the monitor is used, check alarm limits to ensure that they are appropriate for the patient being monitored. Sensors

WARNING: Before use, carefully read the sensor Directions for Use. WARNING: Use only Nellcor oxygen transducers. Use of other oxygen transducers may cause improper oximeter performance. WARNING: Tissue damage can be caused by incorrect application or use of a sensor (e.g., wrapping the sensor too tightly or applying supplemental tape). Inspect the sensor site routinely to ensure skin integrity and correct positioning and adhesion of the sensor. If skin integrity changes, move the sensor to another site. 2

Safety Information

WARNING: Do not use a damaged sensor or one with exposed optical components. Do not immerse sensor completely in water, solvents, or cleaning solutions (the connector is not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide. CAUTIONS Caution: Do not immerse the N-20PA or accessories in liquid or use caustic or abrasive cleaners. Caution: Remove batteries from the N-20PA during prolonged storage.

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SYMBOLS Attention: Refer to operator’s manual Type BF equipment; patient isolated Printer ON button Printer paper advance button (ADV) 2

Date/Day button Battery Check button On/Off button Percent oxygen saturation

min

Pulse rate, measured in beats per minute (bpm) Pulse search indicator Low battery indicator Battery compartment latch

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QUICK GUIDE TO OPERATION Basic Operation

BASIC OPERATION 1.

Plug in an appropriate sensor, close the sensor lock, and apply the sensor to the patient as directed in the sensor Directions for Use.

2.

Turn the N-20PA on by pressing the On/Off button.

3.

If desired, turn the printer on by pressing the Printer ON button.

4.

To turn the N-20PA off, press the On/Off button and hold it for approximately 1 second.

Note:

If no sensor is connected when the monitor is turned on, the monitor will automatically turn off after 60 seconds. If, after the monitor is first turned on and it does not receive valid patient data for 60 seconds, it then turns off.

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FEATURES OF THE N-20PA N-20PA Overview About This Manual

N-20PA OVERVIEW The Nellcor N-20PA portable pulse oximeter provides continuous measurements for both adult and neonates; determines functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate; has a built-in thermal printer; and has both visual and audible alarms. ABOUT THIS MANUAL Global precautionary information is summarized in the Safety Information section. Precautionary information that relates to specific activities is positioned with the relevant text. Conditions that could cause injury are identified by warning statements. Conditions that could cause instrument damage are identified by caution statements.

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SETUP Unpacking and Inspection Testing List of Components Optional Accessories Components Setup

UNPACKING AND INSPECTION Notify the carrier if the shipping carton is damaged. Unpack the N-20PA and accessories. If anything is missing or damaged, contact Mallinckrodt’s Customer Service Department or your local Mallinckrodt representative. TESTING Before using the N-20PA, verify all instrument functions in the Guide to Operations section. LIST OF COMPONENTS 1

Nellcor N-20PA portable pulse oximeter

4

Alkaline “C” size 1.5 V batteries

1

Durasensor oxygen transducer, model DS-100A

2

Oxisensor I I oxygen transducers, model D-25L

1

Operator’s manual

1

EC-4 sensor extension cable

1

Protective boot

1

Rain jacket

11

Setup

OPTIONAL ACCESSORIES •

Printer paper for N-20PA (12 rolls)

•

Carrying case

•

Dual carrying case

COMPONENTS The N-20PA front and rear panels are shown in Figures 1 and 2, respectively. 10 SpO2 %

9 min

8 7

1 2 3 4 5 6

1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Ambient light detector Sensor port and lock Pulse amplitude indicator LOW BATTERY indicator Battery check button On/Off button PULSE SEARCH indicator PULSE RATE display OXYGEN SATURATION display Protective boot

Figure 1: N-20PA Front Panel

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Setup 1. 2. 3. 4. 5. 6. 7.

1

Date/Day button Printer paper advance button (ADV) Printer ON button Paper exit slot Battery compartment latch Battery access door Paper compartment cover

2 3

7 4

6 5

Figure 2: N-20PA Rear Panel SETUP Installing the Batteries

1.

Press the battery compartment latch and remove the battery access door.

2.

Install four alkaline “C” size batteries, oriented as in Figure 3. Replace the battery access door. 13

Setup

Note:

Do not use rechargeable batteries. Otherwise, the low battery indications and battery life specification will be inaccurate. Battery compartment latch Battery access door

– +

Figure 3: Installing Batteries Installing the Protective Boot

To maximize durability, Mallinckrodt recommends keeping the N-20PA in its protective boot during use.

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1.

Slide the N-20PA into the boot, bottom end first.

2.

Stretch the top of the boot slightly to slide it over the top of the instrument.