OxiMax N-295 Operators Manual Dec 2002

Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588 USA Telephone Toll Free 1.800.NELLCOR Mallinckrodt Europe BV Hambakenwetering 1 5231 DD”s-Hertogenbosch The Netherlands Telephone +31.73.648.5200

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 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.: Durasensor, Oxisensor II, Oxinet, Dura-Y, Oxiband, 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; 5,078,136; 5,351,685; 5,368,026; and 5,533,507.

CONTENTS Figures Tables 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... Npb-295 Symbols ... Description Of Controls ... Function Buttons ... Description Of Displays And Visual Indicators ... Description Of Audible Indicators ... Setup... Unpacking And Inspection... Performance Verification ... List Of Components... Optional Accessories ... Monitor Setup ... General Warnings ... Connecting The Npb-295 ... Language Selection... Tilt-Stand Supports... Sensors And Accessories... Selecting A Sensor ... Biocompatibility Testing... Performance Considerations... Wall Mount Plate ... Start-Up And Use... Basic Operation ... Power-On Self-Test (Post) ... Contrast... Monitoring Mode... Pulse Search ... Automatic Shutdown ... Alarms... Description Of Alarms ...

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Contents Management Of Loss-Of-Pulse Alarm... Adjustable Settings ... Pulse Beep Volume ... Alarm Volume ... Alarm Silence Duration ... Disabling Audible Alarms... Alarm Silence Reminder ... Menu ... Menu Structure ... Limits... Trend... Setup... Light ... Default Settings ... Nurse Call Feature... Battery Operation ... Low Battery Indicator ... Disposal Of Device Components... Troubleshooting And Maintenance ... Troubleshooting ... Error Codes ... Other Messages ... Suggested Corrective Actions ... Emi Interference... Obtaining Technical Assistance... Returning The Npb-295 ... Maintenance... Service ... Periodic Safety Checks... Performance Verification ... Cleaning... Specifications... Performance... Measurement Range ... Accuracy ... Pulse Rate Display Update Frequency... Radiated Immunity... Conducted Immunity... Electrical... Instrument ... Battery... Environmental Conditions ... Transport And Storage (In Shipping Container) ... Transport And Storage (Not In Shipping Container) ... Operation ...

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Contents Physical Characteristics ... Weight ... Dimensions... Emissions Compliance... Equipment Classification... Appendix A: Quick Guide To Operation ... Introduction... Settings Adjustments... Appendix B: Principles Of Operation... Oximetry Overview ... Automatic Calibration ... Functional Versus Fractional Saturation ... Measured Versus Calculated Saturation ... Appendix C: Data Port Protocol ... Overview... Connecting To The Data Port... Baud Rate... Real-Time Display Format... Column Headings... Patient Data And Operating Status ... Trend Data Printout (ASCII Mode) ... Trend Data Printout (Graph Mode)... Trend Data Operation ... Nurse Call... Analog Outputs...

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Contents

FIGURES Figure 1: NPB-295 Front Panel Display (Pleth View)... 5 Figure 2: NPB-295 Rear Panel ... 6 Figure 3: Attaching the Tilt-Stand Supports... 15 Figure 4: Attaching the Mounting Plate ... 21 Figure 5: Monitoring Mode Display - Pleth View ... 25 Figure 6: Monitoring Mode Display - Magnified View ... 25 Figure 7: Monitoring Conditions and Alarm Responses ... 30 Figure 8: Menu Items... 35 Figure 9: Alarm Limits Selection ... 37 Figure 10: SpO2 Trend ... 38 Figure 11: Histogram ... 39 Figure 12: 20-Second Trends... 40 Figure 13: Oxyhemoglobin Dissociation Curve ... 69 Figure 14: Data Port Pin Layout ... 73 Figure 15: Real-Time Printout... 74 Figure 16: Trend Data Printout ... 77

TABLES Table 1: Nellcor Sensors ... 18 Table 2: Trend Scale ... 38 Table 3: Error Codes and Messages... 50 Table 4: Settings Adjustments ... 63 Table 6: Data Port Pinouts... 72 Table 7: Status Codes ... 76 Table 8: Voltage between pins 10 and 11 ... 80 Table 9: Analog Pinouts... 80

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SAFETY INFORMATION General Safety Information

GENERAL SAFETY INFORMATION This section contains important safety information related to general use of the NPB-295 pulse oximeter. Other important safety information appears throughout the manual in sections that relate specifically to the precautionary information. 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: Explosion hazard. Do not use the NPB-295 pulse oximeter in the presence of flammable anesthetics or gases. WARNING: The NPB-295 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. WARNING: Chemicals from a broken LCD display panel are toxic when ingested. Use caution when handling a monitor with a broken display panel. Caution: When connecting the NPB-295 to any instrument, verify proper operation before clinical use. Both the NPB-295 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

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Safety Information

Standard 601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 601-1-1 systems requirements. Anyone who connects additional equipment to the signal input port or signal output port (NPB-295 data port connector) 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 system 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.

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INTRODUCTION Intended Use General Operating Principles and Conditions

INTENDED USE The purpose and function of the Nellcor NPB-295 pulse oximeter is to continuously and noninvasively measure functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). It is also used to display plethysmographic waveforms. Refer to Appendix A: Principles of Operation for a more detailed discussion of oximetry. The monitor is intended for use on adult, pediatric, and neonatal patients in all hospital areas, hospital-type facilities, and home environments. It may be used during intra-hospital transport when powered by its internal battery. WARNING: The NPB-295 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-295 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 B, Principles of Operation.

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

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Introduction

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 NPB-295 Symbols Description of Controls Description of Displays and Visual Indicators Description of Audible Indicators

DISPLAYS, CONTROLS, INDICATORS, AND CONNECTORS Figures 1 and 2 show the front and rear views of the NPB-295 and identify displays, controls, and connectors. 1

2 3 4

5

6

7

8

9

11

10

NPB-295

%SP02 BPM LIMITS

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1 2 3 4 5 6 7 8 9

TREND

16 15 14

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

SETUP

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10 11 12 13 14 15 16 17

100 110

LIGHT

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Adjust Up Button Adjust Down Button Contrast Button Softkeys Menu Bar Motion Indicator Pulse Search Indicator Speaker

Figure 1: NPB-295 Front Panel Display (Pleth View)

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Controls, Indicators, and Symbols 1

2

TM

2X T 0.50A 250V

R

IPX1 NRTL/C

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

4

1 2 3 4

MADE IN IRELAND

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

CISPR 11 Group 1 Class B

012 3

NPB-295

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

035554A-0497

U.S. PATENTS: 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

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Equipotential (ground) Terminal Data Port Connector Fuse Receptacle Supply Voltage Selector Switch

Figure 2: NPB-295 Rear Panel NPB-295 SYMBOLS

See Instructions for Use 2X

Fuse Replacement

T 0.50A 250V

Equipotential Terminal

Type BF Applied Part - Not defibrillator proof Date of Manufacture Data Interface

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Controls, Indicators, and Symbols

DESCRIPTION OF CONTROLS Function Buttons

The Power On/Off Button. Used to turn the NPB-295 monitor on or off. The Alarm Silence Button. Used to silence current alarms for the alarm silence duration period. When an alarm has been silenced, pressing the button again reactivates, or “unsilences” the alarm. It is also used to view and adjust alarm silence duration and alarm volume. The Adjust Up Button. Used to increase alarm limit values, alarm silence duration, pulse beep volume, alarm volume, contrast, date and time values, data port baud rate, and to move the cursor to the right (in the trend view). The Adjust Down Button. Used to decrease alarm limit values, alarm silence duration, pulse beep volume, alarm volume, contrast, date and time values, data port baud rate, and to move the cursor to the left (in the trend view). The Contrast Button. Used in conjunction with the Adjust Up/Down Buttons to lighten or darken the display screen. The softkey buttons have multiple uses depending on the label displayed above the button.

DESCRIPTION OF DISPLAYS AND VISUAL INDICATORS The %SpO2 Display. Shows the hemoglobin %SP02

100 oxygen saturation level. It flashes during

loss-of-pulse alarms and when SpO2 is outside of the alarm limits. During Pulse Search, the display will alternate between dashed lines and the last oxygen saturation measurement.

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Controls, Indicators, and Symbols

BPM

86

The Pulse Amplitude Indicator (blip bar). Indicates pulse beat and shows the relative pulse amplitude. As the detected pulse becomes stronger, more bars light with each pulse. This indicator is available only in the magnified (blip) view. The digital Pulse Rate Display. Shows the pulse rate in beats per minute. It flashes during loss-of-pulse alarms and when the pulse rate is outside of the alarm limits. During Pulse Search, the display will alternate between dashed lines and the last pulse rate measurement. The AC Power Indicator. Lights continuously when the NPB-295 is connected to AC power. It also indicates that the battery is charging. It is off when the monitor is being powered by its internal battery. The Low Battery Indicator. Lights continuously to indicate that 15 or fewer minutes of battery capacity remains. The Alarm Silence Indicator. Lights continuously when an audible alarm has been silenced. It flashes when the alarm silence duration has been set to OFF and the Alarm Silence Button is pressed. The Motion Indicator. Lights continuously when the monitor detects motion sufficient enough to affect readings. The Pulse Search Indicator. Lights continuously prior to initial acquisition of a pulse signal, and during Pulse Search. It flashes during a loss-ofpulse signal.

DESCRIPTION OF AUDIBLE INDICATORS Following are descriptions of NPB-295 audible indicators. Power-On Self-Test Pass

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A 1-second tone indicating that the NPB-295 has been turned on and successfully completed the poweron self-test

Controls, Indicators, and Symbols

Valid Button Press

Invalid Button Press

High Priority Alarm Medium Priority Alarm

Low Priority Alarm

Alarm Silence Reminder

Pulse Beep

A short, medium-pitched tone indicating that an appropriate button has been pressed A short, low-pitched tone indicating that a button has been pressed that is not appropriate for the current state of the monitor A high-pitched, fast-pulsing tone indicating loss of pulse A medium-pitched, pulsing tone indicating an SpO2 or pulse rate limit violation A low-pitched, slow-pulsing tone indicating a sensor disconnect, low battery, or monitor failure Three beeps that sound at least every 3 minutes when alarms are silenced with the alarm silence duration set to OFF A single beep sounds for each detected pulse

Volume Setting Tone

A continuous tone that is used to adjust the alarm volume

Confirmation Tone

Three beeps sound to indicate that default settings have been saved or reset to factory defaults or trend data has been deleted

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(Blank Page)

SETUP Unpacking and Inspection Performance Verification List of Components Monitor Setup Language Selection Tilt-Stand Supports

UNPACKING AND INSPECTION Notify the carrier if the shipping carton is damaged. Unpack the NPB-295 and components. If anything is missing or damaged, contact Mallinckrodt’s Technical Services Department or your local Mallinckrodt representative. PERFORMANCE VERIFICATION Before using the NPB-295 for the first time in a clinical setting, you must verify that the monitor is working properly as described in the Power-on Self-test paragraph of the Start-up and Use section. If the monitor does not operate properly, refer to the Troubleshooting section. If you cannot resolve the problem, contact qualified service personnel or your local Mallinckrodt representative. LIST OF COMPONENTS 1

Nellcor NPB-295 pulse oximeter

1

Hospital-grade power cord

1

Nellcor Sensor or ASP-3 assortment pack

1

Nellcor pulse oximetry cable, Model MC-10 or SCP-10

1

Pair of tilt-stand supports

1

Operator’s manual

2

Fuses, 0.5 Amps, 250 Volts

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Setup Optional Accessories

A wall mount plate, as described in the Sensors and Accessories section is available from Mallinckrodt for use with this monitor. MONITOR SETUP General Warnings

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: Disconnect the NPB-295 and Nellcor sensor from the patient during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The NPB-295 may affect the MRI image; the MRI unit may affect the accuracy of oximetry measurements. WARNING: To ensure accurate performance and prevent device failure, do not subject the NPB-295 to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure. WARNING: Do not use an NPB-295 monitor, sensor, cable, or connector that appears to be damaged. WARNING: The NPB-295 is not defibrillator-proof. However, it may remain attached to the patient during defibrillation or while an electrosurgical unit is in use, but the readings may be inaccurate during use and shortly thereafter.

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Setup Connecting The NPB-295

The NPB-295 operates on AC power when the hospital-grade power cord is connected to both the monitor and an AC power source (wall outlet). 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 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. Operating on a discharged battery

The NPB-295 will not operate when its internal battery is discharged, even when the monitor is connected to AC power. Instead, the error code “EEE 04” will be displayed. This feature prevents the accidental use of the monitor with a dead battery. The monitor is only capable of indicating a loss of AC power if its internal battery is functional. The battery may discharge during prolonged storage or shipment. If the monitor has been in storage for more than 2 months it is important to plug the monitor into an AC outlet and allow the battery to charge for approximately 30 minutes before attempting to operate the instrument on AC power. To charge a low battery, connect the monitor to AC power. A full charge of a completely discharged battery takes 14 hours while turned off, or 18 hours during regular use. If AC power is not available, you may operate the NPB-295 on battery power for a limited amount of time. In that case, skip Steps 2, 3, and 4 below. 1. Place the NPB-295 on a flat surface near the patient. With the optional wall mount plate available from Mallinckrodt, the monitor may be attached to a GCX Poly-mount bracket. 2. Plug the female connector end of the power cord into the rear of the monitor. Use only the hospital-grade power cord provided by Mallinckrodt.

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Setup

3. Plug the male connector end of the power cord into a properly grounded AC outlet. 4. Verify that the AC Power Indicator is lit. If it is not, ensure that the supply voltage selector switch matches your AC voltage source. If the indicator still does not light, contact qualified service personnel, your local Mallinckrodt representative, or the Mallinckrodt’s Technical Services Department. WARNING: In the USA, do not connect the monitor to an electrical outlet controlled by a wall switch because the monitor may be accidentally turned off. 5. Select a Nellcor sensor appropriate for the patient to be monitored (see the Sensors and Accessories section of this manual for sensor selection information). WARNING: Do not use an extension cable with the NPB-295 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. 6. Plug the sensor into the MC-10 or SCP-10 sensor cable, and secure the sensor in place by lowering the plastic sensor lock over the sensor connector until it clicks into place (refer to the MC-10 or SCP-10 directions for use). 7. Plug the MC-10 or SCP-10 cable into the sensor port located on the front of the NPB-295. LANGUAGE SELECTION The languages available for display on the screen are English, French, German, Dutch, Portuguese, Spanish, and Italian. The NPB-295 is shipped with the factory default English language displayed. To select the appropriate language after the unit is powered on, press the SETUP softkey, then the NEXT softkey, then the LANG softkey. Use the Adjust Up and Adjust Down Buttons to

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