N-20 and N- 20 P 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. 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 ... Cautions ... Symbols ... Quick Guide to Operation ... Basic Operation... Features of the N-20/N-20P ... N-20/N-20P Overview... About This Manual... Set-Up ... Unpacking and Inspection ... Testing... List of Components ... N-20 and N-20P... Optional Accessories... Components ... Set-Up ... Installing Batteries ... Installing Protective Boot ... N-20P: Setting Clock ... N-20P: Loading Printer Paper ... Guide to Operation ... Basic Operation... Turning Beeper Off (or On) ... Battery Operation ... Description of Modes... Spot-Check Mode... Extended Mode ... Changing Operating Mode ... Nellcor Sensors... Selecting a Sensor ... Cleaning and Reuse ... Performance Considerations...

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Table of Contents Maintenance... Service ... Cleaning... Determining Software Version ... Obtaining Technical Assistance... Returning N-20/N-20P ... Principles of Operation... Oximetry Operating Principles ... Automatic Calibration ... Functional Versus Fractional Saturation ... Measured and Calculated Saturation... Troubleshooting ... Troubleshooting Guide... Specifications ... Performance ... Range... Accuracy ... Electrical ... Battery... Instrument ... Environmental ... Physical... Index ...

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LIST OF FIGURES Figure 1: N-20/N-20P Front Panel ... Figure 2: N-20P (left) and N-20 (right) Rear Panels ... Figure 3: Installing Batteries ... Figure 4: Button Location for Setting Clock ... Figure 5: Removing Paper Cover ... Figure 6: Loading Printer Paper... Figure 7: N-20P Printer Overview ... Figure 8: Spot-Check Mode Printout ... Figure 9: Extended-Mode Printout ... Figure 10: Oxyhemoglobin Dissociation Curve... Figure 11: Removing Paper Exit Door ...

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LIST OF TABLES Table 1: Nellcor Sensors ... 24

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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, carefully read this operator’s manual, sensor and accessory directions for use, and all precautionary information (which is set in boldface type). WARNING: To avoid possible patient strangulation with the sensor extension cable, it is important that a health care professional remain with the patient at all times during use of the N-20/N-20P pulse oximeter. WARNING: The N-20/N-20P is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING: The N-20/N-20P does not incorporate alarms. If alarms are required, use an oximeter with an automatic alarm system. WARNING: Shock hazard. Cover to be removed only by qualified service personnel. There are no user-serviceable parts inside.

WARNING: Use only Nellcor  oxygen transducers. Use of other oxygen transducers may cause improper oximeter performance.

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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. If excessive ambient light is a problem, cover the sensor site with opaque material. WARNING: Do not use the N-20/N-20P or oximetry sensors during magnetic resonance imaging (MRI) scanning. Conducted current could potentially cause burns. Also, the N-20/N-20P may affect the MRI image, and the MRI unit may affect oximeter accuracy. CAUTIONS Do not immerse the N-20/N-20P or accessories in liquid or use caustic or abrasive cleaners. Remove batteries from the N-20/N-20P 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 2

Date/Day Battery check button Measure 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.

2.

Turn the N-20/N-20P on: •

For spot-check mode, press the measure button once.

•

For extended mode (30 minutes), hold the measure button down for 4 to 5 seconds.

3.

N-20P only: During the self-test, check whether PR ON or PR OFF is displayed. To turn the printer on (or off), press the printer ON button.

4.

To turn the N-20/N-20P off before the measurement cycle ends, rapidly press the measure button two times.

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FEATURES OF THE N-20/N-20P N-20/N-20P Overview N-20/N-20P OVERVIEW The Nellcor portable pulse oximeter has both spot-check and 30-minute measurement modes; determines functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate; has a built-in thermal printer (N-20P only); and, has a long battery life. 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. Those that could cause instrument damage are identified by caution statements.

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SET-UP Unpacking and Inspection Testing List of Components Optional Accessories Components Set-up UNPACKING AND INSPECTION Notify the carrier if the shipping carton is damaged. Unpack the N-20/N-20P and accessories. If anything is missing or damaged, contact Mallinckrodt’s Customer Service Department or Mallinckrodt’s representative. TESTING Before using the N-20/N-20P, verify all instrument functions in Section “Guide to Operations.” LIST OF COMPONENTS N-20 and N-20P

1

Nellcor portable pulse oximeter, model N-20 or N-20P

4

Alkaline “C” size 1.5 V batteries

1

Durasensor DS-100A oxygen transducer

2

Oxisensor II D-25L oxygen transducers

1

Operator’s manual

1

EC-4 sensor extension cable

1

Protective boot

9

Set-up

OPTIONAL ACCESSORIES • • • •

Printer Paper for N-20P (12 rolls) Water-resistant jacket Carrying Case Dual Carrying Case

COMPONENTS 10 SpO2 %

9 min

8 7

1 2 3 4 5 6

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

Ambient light detector Sensor port and lock Pulse amplitude indicator LOW BATTERY indicator Battery check button Measure button PULSE SEARCH indicator PULSE RATE display OXYGEN SATURATION display 10. Protective boot

Figure 1: N-20/N-20P Front Panel

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Set-up

1

2 3

7 4

6 5

6 5

1. 2. 3. 4.

Date/Day button Printer paper advance button Printer ON button Paper exit slot

5. 6. 7.

Battery compartment latch Battery access door Paper compartment cover

Figure 2: N-20P (left) and N-20 (right) Rear Panels SET-UP Installing 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.

Note:

Do not use rechargeable batteries. The low battery indications and battery life specification would be inaccurate.

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Set-up Battery compartment latch Battery access door

Ð +

Figure 3: Installing Batteries Installing Protective Boot

To maximize durability, Mallinckrodt recommends keeping the N-20/N-20P in its protective boot during use. 1.

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

2.

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

N-20P: Setting Clock

The N-20P has a 24-hour, real-time clock.

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1.

With the N-20P on, press the 2 button. The OXYGEN SATURATION display shows a “t” (time) followed by a flashing display of the hour. Press → to change the hour (Figure 4).

2.

Press 2 . Press → to change the minutes in the PULSE RATE display.

3.

Press 2 . Press → to change the month in the OXYGEN SATURATION display.

4.

Press 2 . Press → to change the date in the PULSE RATE display.

Set-up

5.

Press 2 . Press → to change the year in the OXYGEN SATURATION display. Then press 2 to exit.

2

SpO

2%

min

Figure 4: Button Location for Setting Clock

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Set-up N-20P: Loading Printer Paper

1.

Remove paper cover.

Figure 5: Removing Paper Cover

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2.

Hold roll in palm as shown, hold paper end stiffly between thumb and fingers. Push paper end firmly into slot approximately 1 inch. Continue holding paper.

3.

Press button on front to power up N-20P.

4.

Keep pushing paper into slot and hold down ADV button (on top).

Set-up Approximately 1 inch

Figure 6: Loading Printer Paper Paper compartment cover

Paper access cover

Press here

Paper exit slot

Paper Paper compartment

2 (Printer ON) (ADV)

(D/D)

Figure 7: N-20P Printer Overview Note:

The paper access cover may be removed to clear paper jams. See Troubleshooting section for details.

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