NPB-40 Handheld Pulse Oximeter Operators Manual

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 Inc. 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 Department, or your local Mallinckrodt representative. The following are trademarks of Mallinckrodt Inc.: Durasensor, Oxiband, Oxisensor, Oxisensor II, OxiCliq, and Dura-Y. 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.

CONTENTS Figures Tables Figures ... Tables ... SAFETY INFORMATION ... General Safety Information ... INTRODUCTION ... Intended use ... General Operating Principles and Conditions ... CONTROLS, INDICATORS, AND SYMBOLS ... Displays, Controls, Indicators, and Connectors ... Other NPB-40 Symbols ... Description of Controls ... Function Keys ... Status Icons ... Description of Visual Indicators and Displays ... Description of Audible Indicators ... SETUP ... Unpacking and Inspection... Testing ... List of Components ... Optional Accessories ... Monitor Setup ... Installing the Batteries... General ... NELLCOR SENSORS ... Selecting a Sensor ... Biocompatibility Testing ... Performance Considerations ... START-UP AND USE... Basic Operation ... Power-On Self-Test (POST) ... Monitoring Mode ... Pulse Search Mode ... Determining Software Version ... Silencing or Adjusting Pulse Beep Volume ... Turning Display Light (Backlight) On or Off ... Storing Event Data ... Printing Event Data ...

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Contents

Preparing the NPB-40 for Printing ... Single Event Report ... Multiple Event Report ... Printer and Printer Accessories ... Sensor Disconnect Indicator ... Battery Operation... Disposal of Device Components ... Performance Considerations... Impact of Patient Conditions on Monitor Readings... TROUBLESHOOTING AND MAINTENANCE ... Troubleshooting ... EMI Interference ... Obtaining Technical Assistance ... Returning the NPB-40 ... Maintenance ... Service ... Cleaning... Periodic Safety Checks ... SPECIFICATIONS ... Performance ... Electrical ... Environmental ... Physical... APPENDIX: PRINCIPLES OF OPERATION ... Oximetry Overview... Automatic Calibration... Functional Versus Fractional Saturation... Measured Versus Calculated Saturation...

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FIGURES Figure 1: NPB-40 Front/Side View ... 5 Figure 2: NPB-40 Front Panel Display... 6 Figure 3: NPB-40 Rear View ... 6 Figure 4: NPB-40 Top View ... 7 Figure 5: Installing Batteries ... 12 Figure 6: Aligning the NPB-40 and Printer ... 25 Figure 7: Single Event Report... 26 Figure 8: Multiple Event Report ... 27 Figure 9: Oxyhemoglobin Dissociation Curve... 43 TABLES Table 1: Nellcor Sensors... 15 iv

SAFETY INFORMATION General Safety Information

GENERAL SAFETY INFORMATION This section contains important safety information related to general use of the NPB-40 monitor. Other important safety information appears throughout the manual in sections that relate specifically to the precautionary information. Be sure to read all text surrounding all precautionary information. Important! Before use, carefully read this manual, accessory directions for use, all precautionary information in boldface type, and specifications. WARNING: The NPB-40 is a prescription device and is to be operated by qualified personnel only. WARNING: The NPB-40 is not equipped with alarms. The monitor is for attended monitoring only, and must be used under the direct supervision of a qualified health care provider. WARNING: Explosion hazard. Do not use the NPB-40 pulse oximeter in the presence of flammable anesthetics. WARNING: The cover should be removed only by qualified service personnel. There are no userserviceable parts inside. WARNING: To ensure accurate performance and prevent device failure, do not expose the NPB-40 to extreme moisture, such as rain. Caution: The NPB-40 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions.

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Safety Information

To ensure accurate readings, consider the environmental conditions that are present and the condition of the patient. See the appropriate sections of the manual for specific safety information related to these conditions. WARNING: If you are uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate means, then make sure the monitor is functioning correctly.

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INTRODUCTION Intended Use General Operating Principles and Conditions

INTENDED USE The Nellcor NPB-40 handheld pulse oximeter is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2 ), and pulse rate (measured by SpO 2 sensor). The monitor is intended for use on adult, pediatric, and neonatal patients. It can be used in mobile environments when protected from excessive moisture such as direct rainfall. Caution: The NPB-40 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING: The NPB-40 is not equipped with alarms. The monitor is for attended monitoring only, and must be used under the direct supervision of a qualified health care provider. WARNING: Do not use the NPB-40 or Nellcor sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The NPB-40 may affect the MRI image; the MRI unit may affect the accuracy of oximetry measurements. Caution: The NPB-40 may be used during defibrillation, but the readings may be inaccurate for a short time. The battery-operated NPB-40 is designed to send previously stored patient data to an external Hewlett-Packard HP82240B printer, available from Mallinckrodt. GENERAL OPERATING PRINCIPLES AND CONDITIONS The NPB-40 uses pulse oximetry to measure oxygen saturation in the blood. Pulse oximetry works by applying a sensor to pulsating arteriolar vascular bed, such as a finger or toe. The sensor contains a dual light source and a photodetector.

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Introduction

Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed is translated in an oxygen saturation measurement (SpO 2). Because a measurement of SpO2 is dependent on light from the sensor, excessive ambient light can interfere with this measurement. WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. Specific information about ambient environmental conditions, sensor application, and patient conditions, is contained throughout this manual.

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CONTROLS, INDICATORS, AND SYMBOLS Displays, Controls, Indicators, and Connectors Other NPB-40 Symbols Description of Controls Description of Visible Indicators and Displays Description of Audible Indicators

DISPLAYS, CONTROLS, INDICATORS, AND CONNECTORS Figures 1 through 4 show the front, side, rear, and top views of the NPB-40 and identify displays, controls, and connectors.

1

2

3

4

1. Function keys 2. Status icons 3. Digital display 4. Sensor port

Figure 1: NPB-40 Front/Side View

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Controls, Indicators, and Symbols

1 15

2

14 13 12

3 4

11

6

5

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

9

8

7

Pulse Amplitude indicator Pulse Rate display Pulse Search indicator Low Battery indicator Sensor Disconnect indicator Power On/Off key (Shift+) Beep On/Off key Display Light key

9. 10. 11. 12. 13. 14. 15.

(Shift+) Print key Store Data key Shift Key Store Data icon Shift Key icon Print icon SpO2% display

Figure 2: NPB-40 Front Panel Display

2

1

3 1. Sound ports 2. Battery compartment latch 3. Battery compartment door

Figure 3: NPB-40 Rear View

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Controls, Indicators, and Symbols

1. Printer infrared window 1

Figure 4: NPB-40 Top View OTHER NPB-40 SYMBOLS Attention: See Instructions for Use Percent oxygen saturation

/min

Pulse rate, measured in beats per minute (bpm) Type BF equipment Alkaline “AA” size, 1.5 V batteries

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Controls, Indicators, and Symbols

DESCRIPTION OF CONTROLS Function Keys Power On/Off key. This key is used to turn the NPB-40 monitor on or off. Shift key. When pressed in conjunction with another Function key, the Shift key changes the function of the other key to that designated by its upper icon. Combo 1 key. When pressed by itself, this key functions as the Store Data key (lower icon). It stores the currently displayed patient data for printing at a later time. Pressing the Shift key before pressing the Combo1 key, changes the function to that of a Print key (upper icon). This action sends patient data to an active, properly aligned, HewlettPackard printer, to generate a printed report. Combo 2 key. When pressed by itself, this key functions as the Display Light key (lower icon). It turns the display backlight on or off. Pressing the Shift key before pressing the Combo 2 key, changes the function that of a Beep On/Off key (upper icon). This action silences or adjusts the pulse beep volume (see “Silencing or Adjusting Beep Volume” in the Start-Up and Use section of this manual). Status Icons Shift icon lights when the Shift key function is in use. Store Data icon lights when the Store Data function is in use. While the icon is lit, either during data storage or printing, the event number is shown on the display.

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Controls, Indicators, and Symbols

Print icon lights when the Print function is in use. Note: while printing, the monitor does not measure SpO2 . The Pulse Search icon lights prior to initial acquisition of a pulse signal, and during Pulse Search mode. The Low Battery icon flashes when 45 minutes or less battery capacity remains (with disposable batteries). The icon flashes at least once per second. Refer to “Battery Operation” in the StartUp and Use section for a discussion regarding use of disposable and rechargeable batteries. The Sensor Disconnect icon lights when the NPB-40 does not detect the connection of an SpO 2 sensor to the monitor. DESCRIPTION OF VISUAL INDICATORS AND DISPLAYS The SpO2 % display show hemoglobin oxygen saturation level. It is updated with each pulse. Synchronous with each pulse, the monitor beeps. If the SpO 2 level drops by more than 2%, the monitor will emit a double-beep tone. The Pulse Amplitude indicator is a 10-segment display that shows the relative pulse amplitude. As the detected pulse becomes stronger, more contiguous segments light with each pulse. The digital Pulse Rate display shows the pulse rate in beats per minute. It is updated with each pulse.

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Controls, Indicators, and Symbols

DESCRIPTION OF AUDIBLE INDICATORS Following are audible indicators for which there are no accompanying symbols, keys, or visual indicators. WARNING: The NPB-40 is not equipped with alarms. The monitor is for attended monitoring only, and must be used under the direct observation of a qualified health care provider.

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Power-Up Self-Test pass

One 2-second tone

No sensor connected at startup (or sensor disconnected)

Error tone (dual-pitch tone) for 3 seconds

SpO 2 drop of more than 2%

1 double-beep tone

No Pulse detected for 30 seconds after power-up

2 triple-beeps, then NPB-40 turns itself off

Pulse acquired, then lost. No pulse detected for 15 minutes, and event memory is empty.

2 triple-beeps, then NPB-40 turns itself off

Pulse acquired, then lost. No pulse detected for 60 minutes, and event memory is not empty.

1 triple-beep every 10 seconds

Low Battery

1 triple-beep tone at 3-minute intervals

Impending Dead Battery

2 triple-beep tones, then NPB-40 turns itself off

SETUP Unpacking and Inspection Testing List of Components Monitor Setup UNPACKING AND INSPECTION Notify the carrier if the shipping carton is damaged. Unpack the NPB-40 and components. If anything is missing or damaged, contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative. TESTING Before using the NPB-40 in a clinical setting, verify that the monitor functions properly by following the instructions in the Start-Up and Use section of this manual. LIST OF COMPONENTS 1 4 1 1 1

Nellcor NPB-40 handheld pulse oximeter Alkaline “AA” size, 1.5 V batteries Durasensor ® oxygen transducer, model DS-100A Operator’s manual Quick Guide adhesive label

Optional Accessories The following items are available from Mallinckrodt for use with this monitor: • • • • •

Protective “Boot” Rain Jacket Carrying Case Hewlett-Packard printer, model HP82240B Hewlett-Packard printer paper

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Setup

MONITOR SETUP Installing the Batteries 1.

Pull the battery compartment latch downward, toward the bottom of the monitor, and remove the battery access door.

2.

Install four “AA” size batteries, oriented as shown in Figure 5. Replace the battery access door. Note:

Install the negative end of each battery first, compressing the battery terminal spring until the positive terminal clears the positive spring, and pressing the battery downward, into place. To remove the batteries, reverse the installation process, removing the positive end of each battery first.

Refer to “Battery Operation” in the Start-Up and Use section of this manual for important information including the types of batteries to be used with the NPB-40, and precautionary information.

Figure 5: Installing Batteries 12

Setup

General WARNING: Explosion hazard. Do not use the NPB-40 handheld pulse oximeter in the presence of flammable anesthetics. WARNING: To ensure patient safety, do not place the monitor in any position that might cause it to fall on the patient. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: To ensure accurate performance and prevent device failure, do not expose the NPB-40 to extreme moisture such as rain.

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NELLCOR SENSORS Selecting a Sensor Performance Considerations SELECTING A SENSOR WARNING: Before use, carefully read the sensor directions for use, including all warnings, cautions, and instructions. WARNING: Do not use a damaged sensor. Do not use a sensor with exposed optical components. WARNING; Use only Nellcor sensors for SpO2 measurements. Other sensors may cause improper NPB40 performance. When selecting a sensor, consider the patient’s weight and activity level, the adequacy of perfusion, the available sensor sites, the need for sterility, and the anticipated duration of monitoring. For more information, refer to Table 1 or contact your local Mallinckrodt representative. Table 1: Nellcor Sensors Sensor

Model

Patient Size

Oxisensor® and Oxisensor II oxygen transducers (Sterile, single-use only)

N-25 I-20 D-20 D-25(L) R-15

<3 or >40 kg 3–20 kg 10–50 kg >30 kg >50 kg

Oxiband® oxygen transducers (Reusable with disposable nonsterile adhesive)

OXI-A/N OXI-P/I

<3 or >40 kg 3–40 kg

Durasensor® oxygen transducer (Reusable, nonsterile)

DS-100A

>40 kg

Nellcor reflectance oxygen transducer (Reusable, nonsterile)

RS-10

>40 kg

Dura-Y ® m u l t i s i t e oxygen transducer (Reusable, nonsterile)

D-YS

>1 kg

OxiCliq® oxygen transducers (Sterile, single-use only)

P N I A

10 to 50 kg <3 or >40 kg 3 to 20 kg >30 kg

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Nellcor Puritan Bennett Sensors

Biocompatibility Testing Biocompatibility testing has been conducted on Nellcor sensors in compliance with ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. The sensors have passed the recommended biocompatibility testing and are, therefore, in compliance with ISO 10993-1. PERFORMANCE CONSIDERATIONS WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. Inaccurate measurements can be caused by: •

incorrect application of the sensor

•

placement of the sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line

•

ambient light

•

patient movement

Loss of pulse signal can occur for the following reasons: •

the sensor is too tight

•

a blood pressure cuff is inflated on the same extremity as the one with the sensor attached

•

there is arterial occlusion proximal to the sensor

Use only Nellcor sensors and sensor cables. Select an appropriate sensor, apply it as directed, and observe all warnings and cautions presented in the directions for use accompanying the sensor. Clean and remove any substances such as nail polish from the application site. Periodically check to see that the sensor remains properly positioned on the patient.

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