NPB-290 Operators Manual Rev C Sept 2002

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’s Technical Services Department, or your local Mallinckrodt representative. Purchase of this instrument confers no express or implied license under any Mallinckrodt patent to use the instrument with any sensor that is not manufactured or licensed by Mallinckrodt. The following are trademarks of Mallinckrodt Inc.: Oxisensor II, Oxiband, Durasensor, Dura-Y, Pedi-Check, and OxiCliq. Covered by one or more of the following U.S. Patents and foreign equivalents: 4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,869,254; Re. 35,122; 4,928,692; 4,934,372; 5,078,136; and 5,368,224.

CONTENTS Figures Tables

CONTENTS CONTENTS ... Contents ... 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-290 Symbols ... Description of Controls ... Function Buttons ... Indicators ... Description of Visual Indicators and Displays ... Description of Audible Indicators... QUICK GUIDE TO OPERATION ... Basic Operation... Setup... Using the Monitor... Adjust Pulse Beep Volume... Alarm Functions ... View/Adjust Alarm Limits ... Audible Alarm Silence... Adjust Alarm Silence Duration ... Disabling Audible Alarms ... Adjust Alarm Volume ... SETUP ... Unpacking and Inspection... Performance Verification ...

iii iii vii vii 1 1 3 3 3 5 5 6 7 7 7 8 8 11 11 11 12 13 13 13 13 14 14 14 15 15 15

iii

Contents List of Components ... 15 Optional Accessories... 15 Monitor Setup... 16 General... 16 Setting Up the NPB-290 ... 16 SENSORS AND ACCESSORIES... 21 Selecting a Sensor... 21 Biocompatibility Testing ... 22 Performance Considerations ... 22 Optional Accessories ... 24 Wall Mount Plate ... 24 Tilt-Stand Supports... 25 START-UP AND USE ... 27 Basic Operation ... 27 Power-On Self-Test (POST)... 28 Silencing or Adjusting Pulse Beep Volume ... 29 Monitoring... 30 Pulse Search ... 30 Automatic Shutdown ... 31 Alarms ... 32 Description of Alarms ... 32 Adjusting Alarm Limits ... 33 Adjusting Audible Alarm Silence Duration... 35 Disabling Audible Alarms ... 36 Alarm Silence Reminder... 37 Adjusting Audible Alarm Volume ... 37 Management of Loss-of-Pulse Alarm... 37 Nurse Call Feature ... 41 Trend Data ... 41 Battery Operation... 43 Low Battery Indicator... 43 Disposal of Device Components... 44 Performance Considerations ... 44 Impact of Patient Conditions on Monitor Readings 44 TROUBLESHOOTING AND MAINTENANCE ... 47 Troubleshooting ... 47 EMI Interference ... 50 Obtaining Technical Assistance... 51

iv

Contents Returning The NPB-290 ... Maintenance ... Service ... Periodic Safety Checks... Performance Verification ... Cleaning ... SPECIFICATIONS... Performance ... Measurement Range ... Accuracy ... Pulse Rate Display Update Frequency... Immunity... Electrical ... Instrument ... Battery... Environmental Conditions ... Operating Temperature ... Transport/Storage Temperature ... Humidity ... Altitude ... Environmental Protection ... Physical ... Weight ... Size ... Equipment Classification ... APPENDIX A: PRINCIPLES OF OPERATION ... Oximetry Overview ... Automatic Calibration... Functional versus Fractional Saturation ... Measured versus Calculated Saturation... APPENDIX B: DATA PORT PROTOCOL ... Overview... Trend Data... Connecting to the DATA Port ... Real-Time Display Format... Column Headings ... Patient Data and Operating Status ... Trend Data Printout ...

51 51 51 52 52 52 53 53 53 53 54 54 54 54 54 55 55 55 55 55 56 56 56 56 56 57 57 57 58 58 61 61 61 62 64 65 66 68

v

Contents Trend Data Operation... 69 Nurse Call ... 70 Analog Outputs ... 70

vi

Contents

FIGURES Figure 1: NPB-290 Front Panel Display ... Figure 2: NPB-290 Rear Panel ... Figure 3: Connecting the Power Cord ... Figure 4: Connecting an MC-10 or SCP-10 Sensor Cable to the NPB-290... Figure 5: Attaching the Mounting Plate ... Figure 6: Attaching the Tilt-Stand Supports... Figure 7: Monitoring Conditions and Alarm Responses ... Figure 8: Oxyhemoglobin Dissociation Curve ... Figure 9: Serial Port Pin Layout... Figure 10: Real-Time Printout... Figure 11: Trend Data Printout ...

5 6 18 19 25 26 39 59 64 65 69

TABLES Table 1: Nellcor Sensors ... Table 2: Data Port Pinouts... Table 3: Status Codes ... Table 4: Analog Pinouts...

22 63 68 71

vii

(Blank Page)

SAFETY INFORMATION General Safety Information

GENERAL SAFETY INFORMATION This section contains important safety information related to general use of the NPB-290 pulse oximeter. 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. Specific information about ambient environmental conditions, sensor application, and patient conditions is contained throughout this manual. Important! Before use, carefully read this manual, accessory directions for use, all precautionary information in boldface type, and specifications. WARNING: Explosion hazard. Do not use the NPB-290 pulse oximeter in the presence of flammable anesthetics. WARNING: The NPB-290 is a prescription device and is to be operated by qualified personnel only. WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. See the appropriate sections of the manual for specific safety information. Caution: When connecting the NPB-290 to any instrument, verify proper operation before clinical use. Both the NPB-290 and the instrument connected to it must be connected to a grounded outlet. Accessory equipment connected to the monitor’s data interface must be certified according to IEC Standard 950 for data-processing equipment or IEC Standard 601-1 for electromedical equipment. All combinations of equipment must be in

1

Safety Information

compliance with IEC Standard 601-1-1 systems requirements. Anyone who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of system standard IEC Standard 601-1-1 and the electromagnetic compatibility standard IEC Standard 601-1-2. 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.

2

INTRODUCTION Intended Use General Operating Principles and Conditions

INTENDED USE The Nellcor NPB-290 pulse oximeter is intended for continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor). The monitor is intended for use on adult, pediatric, and neonatal patients in all hospital areas, hospital-type facilities, and in the home environment. It may be used during intra-hospital transport when powered by its internal battery. WARNING: The NPB-290 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. GENERAL OPERATING PRINCIPLES AND CONDITIONS The NPB-290 uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed, such as a finger or toe. The sensor contains a dual light source and a photodetector. 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 into a measurement of functional oxygen saturation (SpO2). Note:

For an explanation of functional versus fractional saturation, refer to Appendix A, Principles of Operation.

Because a measurement of SpO2 is dependent on light from the sensor, excessive ambient light can interfere with this measurement.

3

Introduction

Specific information about ambient environmental conditions, sensor application, and patient conditions, is contained throughout this manual.

4

CONTROLS, INDICATORS, AND SYMBOLS Displays, Controls, Indicators, and Connectors Other NPB-290 Symbols Description of Controls Description of Visible Indicators and Displays Description of Audible Indicators

DISPLAYS, CONTROLS, INDICATORS, AND CONNECTORS Figures 1 and 2 show the front and rear views of the NPB-290 and identify displays, controls, and connectors. 1

2 3 4

5

6

7

8

9

11

10

NPB-290

16

1 2 3 4 5 6 7 8

15 14

SpO2 Sensor Port Power On/Off Button Low Battery Indicator AC Power Indicator %SpO2 Display Pulse Amplitude Indicator Pulse Rate Display Alarm Silence Indicator

13

9 10 11 12 13 14 15 16

12

Alarm Silence Button Adjust Up Button Adjust Down Button Pulse Search Indicator Motion Indicator Lower Alarm Limit Button Upper Alarm Limit Button Speaker

Figure 1: NPB-290 Front Panel Display

5

Controls, Indicators, and Symbols 3

2

1

NPB-290 SN

2X

NELLCOR PURITAN BENNETT, INC. PLEASANTON, CA 94588, U.S.A.

T 0.50A 250V

NELLCOR PURITAN BENNETT EUROPE BV, 's-HERTOGENBOSCH, THE NETHERLANDS

R

IPX1 012 3

NRTL/C

5

1 2 3 4 5

100-120 V 200-240 V 50/60 Hz 20VA

MADE IN U.S.A.

035285X-1296

U.S. PATENTS: 4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,869,254; 4,911,167; 4,928,692; 4,934,372; 5,078,136

4

Equipotential Terminal AC Connector Data Port Connector Fuse Receptacle Supply Voltage Selector Switch

Figure 2: NPB-290 Rear Panel OTHER NPB-290 SYMBOLS See Instructions for Use 2X T 0.50A 250V

Fuse Replacement Date of Manufacture

Data Interface

Equipotential Terminal

Type BF Applied Part  Not Defibrillator-Proof

6

Controls, Indicators, and Symbols

DESCRIPTION OF CONTROLS Function Buttons The Power On/Off button. Used to turn the NPB-290 monitor on or off. The Alarm Silence button. Used to silence current alarms for the alarm silence duration period. It is also used to view and adjust alarm silence duration and the alarm volume. The Adjust Up button. Used to increase alarm limit values, alarm silence duration, as well as alarm and pulse beep volumes. Also used to scroll through menu items. The Adjust Down button. Used to decrease alarm limit values, alarm silence duration, as well as alarm and pulse beep volumes. Also used to scroll through menu items. The Upper Alarm Limit button. Used to view upper alarm limits. When this button is pressed at the same time as the Lower Alarm Limit button, menu options are accessible. It is also used to select menu options. The Lower Alarm Limit button. Used to view lower alarm limits. When this button is pressed at the same time as the Upper Alarm Limit button, menu options are accessible. It is also used to exit menus without change. Indicators The AC Power indicator. Lights continuously when the NPB-290 is connected to AC power. This light is off when the monitor is being powered by its internal battery. When lit, it also indicates that the battery is charging. The Low Battery indicator. When 15 minutes or less battery capacity remains, the indicator lights continuously and a low priority alarm sounds. The Alarm Silence indicator. Lights continuously when an active audible alarm has been silenced. It flashes when alarms are permanently silenced. The Motion indicator. Lights continuously when the monitor detects motion sufficient enough to affect readings.

7

Controls, Indicators, and Symbols The Pulse Search indicator. Lights continuously prior to initial acquisition of a pulse signal, and during Pulse Search mode. It flashes during loss of pulse.

DESCRIPTION OF VISUAL INDICATORS AND DISPLAYS The %SpO2 Display. Shows the hemoglobin oxygen saturation level. The Pulse Amplitude indicator. 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.

DESCRIPTION OF AUDIBLE INDICATORS Following are descriptions of NPB-290 audible indicators.

8

Power-On Self-Test (POST) pass

One 1-second tone indicating that the NPB-290 has been turned on and successfully completed the power-on self-test.

Valid Button Press

A single tone indicating that an appropriate button has been pressed.

Invalid Button Press

A single low-pitched tone indicating that a button has been pressed that is not appropriate for the current state of the monitor.

High Priority Alarm

A high-pitched, fast, pulsing tone indicating loss-of pulse.

Medium Priority Alarm

A medium-pitched, pulsing tone indicating an SpO2 or pulse rate limit violation.

Low Priority Alarm

A low-pitched, slow, pulsing tone indicating a sensor disconnect, low battery, or monitor failure.

Controls, Indicators, and Symbols Pulse Beep

A single beep sounds for each detected pulse.

Confirmation Tone

Three beeps sound to indicate a successful menu operation.

Alarm Silence Reminder

Three beeps sound at least every 3 minutes as a reminder that the audible alarm has been silenced.

Volume Setting Tone

A continuous tone that is used to adjust the alarm volume.

9

(Blank Page)

QUICK GUIDE TO OPERATION Basic Operation Alarm Functions

This Quick Guide to Operation section is intended for use by experienced NPB-290 users. First-time users of this instrument should read the entire manual before use. BASIC OPERATION The NPB-290 operates on AC power when the hospital-grade power cord is connected to both the monitor and an AC power source (wall outlet). The monitor will not operate when its internal battery is discharged, even when the monitor is connected to AC power. Since the battery may become discharged during prolonged storage or shipment, it is important to plug the NPB-290 into an AC wall outlet and allow the battery to charge for a few minutes before attempting to turn on the instrument. Setup

1. With the monitor on a flat, stable surface, plug the female connector end of the hospital-grade power cord into the rear of the monitor. Note: The supply voltage selector switch allows connection of the monitor to AC power ranging from 100 VAC to 240 VAC. The switch has two positions: one for the 100-120 VAC (“115”), and one for 200-240 VAC (“230”). Ensure that the supply voltage selector switch on the rear panel is set to the proper voltage. 2. Verify that the supply voltage selector switch is in the correct position for your location (see note above). Plug the male connector end of the power cord into a properly grounded AC outlet. WARNING: In the USA, do not connect the monitor to an electrical outlet controlled by a wall switch.

11

Quick Guide to Operation

3. Select a Nellcor sensor that is appropriate for the patient being monitored. 4. Attach the sensor to the patient, following the instructions in the sensor directions for use. WARNING: Do not use an extension cable with the NPB-290 monitor (other than the MC-10 or SCP-10 sensor cable). Use of another sensor extension cable will have an adverse effect on performance. Do not attach to the sensor port any cable that is intended for computer use. 5. Connect the sensor to the end of the MC-10 or SCP-10 cable that has the clear plastic sensor lock. Secure the sensor in place by lowering the sensor lock over the sensor connector. Gently press on the sensor lock until it clicks into place. 6. Connect the other end of the MC-10 or SCP-10 cable into the NPB-290 by gently pushing it straight into the sensor port located on the front of the monitor. 7. Ensure that nothing is placed in front of the monitor’s speaker that could interfere with the audible alarm being heard. Using the Monitor

1. Turn on the NPB-290 by pressing the Power On/Off button. The monitor conducts a power-on self-test (POST) and signals successful completion of the test with a 1-second tone. WARNING: If you do not hear the POST pass tone, do not use the monitor. 1. During POST, check to see that all display indicators and segments light, then listen for the completion tone. This tone not only indicates the successful completion of POST, it also confirms that the audible alarm is functional. 2. The Pulse Search indicator lights, and the monitor displays zeroes while it searches for a valid pulse. If no sensor is attached, dashes are displayed and the Pulse Search indicator is not lit.

12