Nellcor NPB-4000, N-4000C User manual

OPERATOR’S MANUAL

NPB-4000/4000C Patient Monitor

Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Nellcor Puritan Bennett, Durasensor, C-LOCK, Oxisensor II, Dura-Y, and the Nellcor

Puritan Bennett knob configuration are trademarks of Nellcor Puritan Bennett Inc.

To obtain information about a warranty, if any, for this product, contact Nellcor’s Technical Services Department, or your local Nellcor representative.

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; 5,368,224 Re. 35,122; 4,928,692; 4,934,372; 5,078,136.

Figures Tables

Safety Information ......................................................................1

General Safety Information ...................................................1

Introduction.................................................................................5

Intended Use.........................................................................5

About This Manual ................................................................5

Controls, Indicators, And Symbols...........................................7

Front Panel ...........................................................................7

Rear Panel ..........................................................................13

Quick Guide To Operation .......................................................15

Features.....................................................................................17

Physical/Mechanical ...........................................................17

Electrical .............................................................................18

Display ................................................................................18

Auxiliary Outputs.................................................................19

Options and Accessories ....................................................19

Setup and Use...........................................................................21

Unpacking and Inspection ..................................................21

Power Cable Connections ..................................................22

Measurement Cable Connections ......................................22

Power On and Self-Test .....................................................24

Set Date and Time ..............................................................26

Display and Operation .............................................................29

The Display Configuration...................................................29

Controlling Monitor Operation and Display Elements .........35

Alarms and Limits.....................................................................41

General ...............................................................................41

Alarm Priority ......................................................................42

Loss-Of-Monitoring Alarm ...................................................43

Visual Alarm Indicators .......................................................43

Audible Alarm Indicators .....................................................44

Setting And Changing Alarm Limits ....................................45

Using The Alarm/Limits Screen ..........................................45

Auto-Set Alarm Limits .........................................................50

Using The Numeric Frame .................................................50

Alarm Limits and Factory-Set Default Values .....................50

Alarm Silence Switch ..........................................................51

Alarm Suspend ...................................................................52

ECG Monitoring ........................................................................55

General ...............................................................................55

ECG Safety Information ......................................................55

iii

Contents

Setup Connections............................................................. 57

Controlling ECG Functions Via Numeric Frame ................ 60

Controlling ECG Waveform Via Graphic Frame ................ 61

NIBP Monitoring....................................................................... 65

General .............................................................................. 65

NIBP Safety Information..................................................... 65

Setup Connections............................................................. 67

NIBP Measurement Modes ................................................ 68

Controlling NIBP Functions Via Numeric Frame................ 71

Monitoring ...................................................................... 73

SpO

General .............................................................................. 73

Safety Information .................................................... 74

SpO

Setup Connection............................................................... 75

Functions Via Numeric Frame ............... 78

Controlling SpO Controlling SpO

Waveform Via Graphic Frame ............... 80

Respiration Monitoring............................................................ 83

General .............................................................................. 83

Respiration Safety Information........................................... 83

Setup Connections............................................................. 84

Controlling Respiration Functions Via Numeric Frame ...... 84

Controlling Respiration Waveform Via Graphic Frame...... 86

Temperature Monitoring.......................................................... 89

General .............................................................................. 89

Controlling Temperature Functions Via Numeric Frame ... 90

Trends ....................................................................................... 91

General .............................................................................. 91

Displaying Trend Data........................................................ 92

Selecting A 2-Hour Portion Of The Graphical Trend For

Display:............................................................................... 94

Printing Trend Information (Printer Option Installed): ........ 95

Changing The Vertical Scale Range .................................. 95

Selecting Different Trend Records..................................... 96

Graphical Trend Operation Summary ................................ 97

Tabular Trend Data ............................................................ 98

Transferring Trends Via RS-232 ........................................ 98

Printing ..................................................................................... 99

General .............................................................................. 99

Operator Maintenance and Troubleshooting...................... 103

Error Messages................................................................ 103

Service ............................................................................. 103

Obtaining Technical Assistance ....................................... 105

Returning System Components ....................................... 105

Printer Paper Replacement.............................................. 106

Specifications......................................................................... 109

Scope ............................................................................... 109

RS-232 Interface......................................................................117

Defib Sync Output ..................................................................122

Optional Accessories.............................................................123

FIGURES

Figure 1: Front Panel, NPB-4000/C.............................................7

Figure 2: Rear Panel, NPB-4000/C ...........................................13

Figure 3: NPB-4000/C Patient Monitor ......................................17

Figure 4: Copyright Screen........................................................25

Figure 5: Typical Screen for No Patient Leads ..........................25

Figure 6: Typical Screen, Valid Monitored Signals ....................26

Figure 7: A Typical Monitoring Screen.......................................30

Figure 8: Big Numbers Screen ..................................................34

Figure 9: Highlighted ECG Graphic;

Figure 10: SpO2 Screen ............................................................38

Figure 11: Alarm/Limits Screen Presentation ............................46

Figure 12: Alarm Suspend Screen ............................................52

Figure 13: Standard ECG Leads Placement .............................58

Figure 14: Modified Chest Lead (MCL1) Placement

Figure 15: Heart Rate Display ...................................................60

Figure 16: ECG Waveform ........................................................62

Figure 17: NIBP Screen.............................................................71

Figure 18: SpO2 Screen ............................................................78

Figure 19: SpO2 Waveform Screen ..........................................80

Figure 20: Respiration Rate Screen ..........................................84

Contents

General .............................................................................109

Electrical ...........................................................................110

Environmental ...................................................................111

Measuring Parameters .....................................................111

Trends...............................................................................115

Overview ...........................................................................117

Cable Connection .............................................................117

Nurse-Call .........................................................................118

Exporting Trend Data........................................................118

Defib Sync Output.............................................................122

NPB-4000/C Defib Sync ...................................................122

Printer ...............................................................................123

GCX Mount .......................................................................123

Accessory Bag ..................................................................123

Defib Sync Cable ..............................................................123

DC Input Cable .................................................................123

Level 1 and Level 2 Menus.........................................37

(if using MCL1, select Lead II) ..................................59

Contents

TABLES

Figure 21: Respiration Waveform Screen ................................ 86

Figure 22: Temperature Screen................................................ 90

Figure 23: Graphical and Tabular Trend Screens .................... 93

Figure 24: Accessing the Trend Scroll Capability ..................... 96

Figure 25: Printer Operator Controls......................................... 99

Figure 26: Real-Time Printout................................................. 100

Figure 27: Graphic Trend Printout .......................................... 101

Figure 28: Tabular Trend Printout........................................... 101

Figure 29: Loading Thermal Paper in Printer .......................... 106

Table 1: Front Panel Connectors ................................................ 8

Table 2: Switch Panel Symbols .................................................. 8

Table 3: Display Symbols.......................................................... 10

Table 4: Rear Panel Connectors............................................... 13

Table 5: Quick Guide Procedure .............................................. 15

Table 6: Battery Charging Front panel Indications.................... 24

Table 7: NPB-4000C Color Description .................................... 31

Table 8: NPB-4000C Battery Icon............................................. 33

Table 9: SpO2 Screen Menus................................................... 39

Table 10: Visual Alarm Flashing Rates..................................... 43

Table 11: Audible Alarm Characteristics................................... 44

Table 12: Alarm/Limits Menu .................................................... 46

Table 13: Auto-Set Limits Formulas ......................................... 50

Table 14: Alarm Limits Ranges and Factory-Set Limits............ 51

Table 15: ECG Lead Color Coding ........................................... 58

Table 16: ECG Lead Pairs (for Standard Leads Placement).... 59

Table 17: Heart Rate Menu....................................................... 60

Table 18: ECG Waveform Menu .............................................. 63

Table 19: Cuff Sizes.................................................................. 67

Table 20: Low Priority NIBP Alarms.......................................... 70

Table 21: NIBP Menu................................................................ 72

Table 22: SpO2 Sensors........................................................... 76

Table 23: SpO2 Menu............................................................... 79

Table 24: SpO2 Waveform ....................................................... 81

Table 25: Respiration Rate Menu ............................................. 85

Table 26: Respiration Waveform Menu .................................... 87

Table 27: Temperature Menu ................................................... 90

Table 28: SpO2 Graphical Trend Menu .................................... 97

Table 29: RS-232 Serial Interface Connections ..................... 117

SAFETY INFORMATION

General Safety Information

GENERAL SAFETY INFORMATION

This section contains important safety information related to general use of the NPB-4000 monochrome display patient monitor and NPB-4000C color display patient monitor. Other important safety information appears throughout the manual in sections that relate specifically to the precautionary information. Read all text surrounding all precautionary information. The monitors will be referred to as NPB-4000/C throughout this manual.

Important! Before use, carefully read this manual, accessory directions for use, all precautionary information in boldface type, and specifications.

WARNING: In the USA, do not connect to an electrical outlet controlled by a wall switch because the device may be accidentally turned off.

WARNING: As with any medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

Warning: Do not use the NPB-4000/C patient monitor to monitor neonates.

WARNING: Explosion hazard. Do not use the NPB-4000/C in the presence of flammable anesthetics or gases.

WARNING: The NPB-4000/C patient monitor is a prescription device and is to be operated by qualified personnel only.

WARNING: The user must check the equipment prior to use and ensure its safe and proper use.

Safety Information

WARNING: The NPB-4000/C is defibrillator proof. 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.

WARNING: The NPB-4000/C is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

WARNING: To ensure patient safety, do not place the monitor in any position that might cause it to fall on the patient.

WARNING: Disconnect the NPB-4000/C and sensors during magnetic resonance imaging (MRI) scanning. Use during MRI could cause burns or adversely affect the MRI image or the monitor’s accuracy. Also, to avoid burns, remove the sensors from the patient before conducting MRI.

WARNING: Do not lift the monitor by the sensor cable, blood pressure hose, or power cord because the cable, lead, or cord could disconnect from the monitor, causing the monitor to drop on the patient.

WARNING: Do not use the NPB-4000/C to monitor patients who are linked to heart/lung machines.

WARNING: The NPB-4000/C may not operate effectively on patients who are experiencing convulsions or tremors.

WARNING: Occasionally, electrical signals at the heart do not produce a peripheral pulse. If a patient’s beat-to-beat pulse amplitude varies significantly (for example, pulsus alternans, atrial fibrillation, rapid-cycling artificial ventilator), blood pressure and pulse rate readings can be erratic and an alternate measuring method should be used for confirmation.

Safety Information

CAUTION: When connecting the NPB-4000/C patient monitor to any instrument, verify proper operation before clinical use. Both the NPB-4000/C 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 compliance with IEC Standard 601-1 system requirements. Anyone who connects additional equipment to the signal input or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of standard IEC Standard 601-1-1. If in doubt, consult Nellcor’s Technical Services Department or your local Nellcor’s representative.

[THIS PAGE INTENTIONALLY LEFT BLANK]

INTRODUCTION

Intended Use About this Manual

INTENDED USE

The purpose and function of the Nellcor NPB-4000/C patient monitor is to monitor ECG, heart rate, noninvasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, respiration, and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances.

WARNING: The NPB-4000/C is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

ABOUT THIS MANUAL

This manual explains how to set up and use the NPB-4000/C patient monitor. Important safety information relating to general use of the NPB-4000/C appears before this introduction. Other important safety information is located throughout the text where applicable. Read the entire manual including the

Safety Information section, before you operate the monitor.

[THIS PAGE INTENTIONALLY LEFT BLANK]

CONTROLS, INDICATORS, AND SYMBOLS

Front Panel Rear Panel

FRONT PANEL

See Figure 1. The front panel controls and indicators are arranged in groups:

123

Figure 1: Front Panel, NPB-4000/C

1. Display: (the major area of the panel)

2. Switch Panel: (to the right of the display)

3. Patient Connectors: (along the bottom of the panel)

4. Control Knob: (the lower right corner of the panel)

Controls, Indicators, and Symbols

Patient Monitoring Connectors

All patient connections to the NPB-4000/C are classified as type CF, which specifies their degree of protection against electrical shock, and all are rated as defibrillator-proof. Consequently, each connector is marked with the following symbol.

Symbol for Defibrillator-proof Type CF Equipment

A unique icon identifying the parameter being monitored through that connector identifies each connection. Table 1 defines the monitored parameter, connector compatibility, and icon.

Table 1: Front Panel Connectors

Monitored Parameter

ECG

Compatible with Nellcor CE-10 ECG Cables

SpO

Compatible with Nellcor sensors and sensor extension cables

NIBP

Compatible with Nellcor SHBP-10 blood pressure hose

Temperature

Compatible with YSI Series 400 temperature probes

Switch Panel

The symbols identifying the switches and light emitting diode (LED) indicators on the Switch Panel are described in Table 2.

Switched/LED

Descriptor

On/Standby Switch

Connector Compatibility Icon

SpO

Table 2: Switch Panel Symbols

Icon Operation

Toggles NPB-4000/C between ON and STANDBY modes

Controls, Indicators, and Symbols

Table 2: Switch Panel Symbols

Switched/LED

Descriptor

AC source LED Indicator

DC source LED Indicator

NIBP Start/Stop Switch

NIBP STAT icon

Alarm Silence Switch

Heart Rate Tone Volume Switch

Icon Operation

When lit, indicates an AC source connected and charging the battery

When lit, indicates a DC source connected and charging the battery

Toggles between starting and stopping NIBP measurement

Indicates STAT mode, which is activated by pressing and holding the NIBP switch for 2 seconds

Temporarily silences the audible alarm sound for a pre-set interval

Enables the knob to adjust volume of the audible tone

Contrast Adjust Switch

NPB-4000 Pressing switch

causes screen contrast to change to an average setting. Also enables the knob to adjust the contrast of the display.

NPB-4000C Pressing switch causes the screen to switch to the alternate set of colors (black background vs. white background).

Controls, Indicators, and Symbols

Display Symbols

The symbols and icons used in the NPB-4000/C patient monitor display are described in Table 3.

Table 3: Display Symbols

Display - Numeric Frame Symbols

Heart Rate

SpO2

SpO

/min

Heart rate icon. Identifies the frame and indicates the units, beats per second. Always displayed.

Heart rate determined from SpO2 sensor. Displayed when heart rate is derived from the SpO

Heart rate determined from ECG measurement. Displayed when heart rate is derived from the ECG measurement.

Heart rate determined from NIBP measurement. Displayed when heart rate is derived from the NIBP measurement.

Heart rate alarm. Displayed when a heart rate alarm limit has been violated.

Audible Alarm Off. Displayed when audible alarm is silenced. This icon is in reverse video to indicate that the audible alarm is temporarily silenced.

SpO2 frame icon. Identifies the frame and indicates the units (percent). Always displayed.

Pulse amplitude indicator.

sensor.

SpO2alarm. Displayed when an SpO2 alarm limit has been violated.

Audible Alarm Off. Displayed when the audible alarm is silenced. This icon is in reverse video to indicate that the audible alarm is temporarily silenced.

NIBP

Controls, Indicators, and Symbols

Table 3: Display Symbols

mmHg

140/90

(106)

180

Respiration Rate

/min

NIBP icon and units of measure

Systolic blood pressure/Diastolic blood pressure (Mean arterial pressure value)

Auto mode icon and minutes between automatic NIBP measurement

STAT mode icon appears when STAT mode is active

Display of the initial cuff pressure to be used on the next measurement.

Timer icon and minutes since last NIBP measurement

NIBP alarm. Displayed when an NIBP alarm limit has been violated.

Audible Alarm Off. Displayed when audible alarm is silenced

Respiration icon and units of measure

Respiration alarm. Displayed when a respiration rate alarm limit has been violated.

Temperature

Audible Alarm Off. Displayed when audible alarm is silenced

Temperature icon

Temperature unit of measure, ° C or ° F

Temperature alarm. Displayed when a temperature alarm limit has been violated.

Audible Alarm Off. Displayed when audible alarm is silenced.

Controls, Indicators, and Symbols

Table 3: Display Symbols

Display - Graphic Frame Symbols

ECG Waveform

ECG icon

Size bar, 1 cm high

0.5

Size scale

Lead pair

SpO2 Waveform

SpO

SpO2 icon

Respiration Waveform

( )

Respiration icon

REAR PANEL

Five connectors are located on the rear panel of NPB-4000/C. See Figure 2 and refer to Table 4. The rear panel includes threaded standoffs for attaching a GCX mounting system accessory.

Controls, Indicators, and Symbols

Figure 2

Description Connector Type Icon

Callout

1 DC Input

2 Equipotential

3 Defib Sync

4 AC Input

5 RS-232 I/O

Figure 2: Rear Panel, NPB-4000/C

Table 4: Rear Panel Connectors

2-line; + and ground

Equipotential ground

2.5 mm subminature phone jack 3-line connector,

100 - 240V ~

IEC 320 receptacle

DB-9 (male)

10 - 16V

50 - 60 Hz

1 A

RS-232

[THIS PAGE INTENTIONALLY LEFT BLANK]

QUICK GUIDE TO OPERATION

Table 5: Quick Guide Procedure

Step Icon Operation

1 … Connect patient cables to front panel connectors

(refer to Setup & Use, page21).

2 … As appropriate, attach cuff, sensor, electrodes,

probe to patient and cables to the monitor (refer to Monitoring sections pages 55, 65, 73, 83 and

89).

3 Press On/Standby switch to turn monitor on. The

NPB-4000/C will go through a self-test before displaying the monitoring screen.

4 Check the alarm limits; adjust if required. Rotate

the knob to highlight the Alarm Limits icon, then press the knob to view all alarm limits. To change a limit, rotate the knob until the desired limit is highlighted, then press the knob. Rotate the knob again until desired value is obtained. Repeat as necessary. Upon completion, rotate the knob to highlight Return, then press the knob to exit the monitoring screen (refer to Alarms & Limits, page 41).

—

— To adjust the heart rate tone volume, press the

NPB-4000 To adjust the screen contrast, press the Contrast Adjust switch and rotate the knob to give the best viewing angle. NPB-4000C To adjust color set, press the Contrast switch until the screen provides an optimum contrast in the intended setting.

Heart Rate Tone Volume switch and rotate the knob to give the desired volume.

Quick Guide to Operation

Table 5: Quick Guide Procedure

Step Icon Operation

— To initiate a blood pressure measurement, press

the NIBP Start/Stop switch. Press and hold the NIBP Start/Stop switch for 2 seconds to initiate STAT mode. A press during any measurement terminates the measurement and deflates the cuff (refer to NIBP Monitoring, page 65).

— To temporarily silence an audible alarm, press the

Alarm Silence switch (refer to Alarms & Limits, page 41).

— To produce a 20-second printout (if optional

printer installed), press Snapshot switch on the printer. Press the Continuous switch to produce a continuous printout (refer to Printing, page 99).

5 Press the On/Standby switch to terminate

monitoring and blank the screen.

FEATURES

Physical/Mechanical Electrical Display Auxiliary Outputs Options and Accessories

PHYSICAL/MECHANICAL

The NPB-4000/C patient monitor is a lightweight, compact, multi-parameter patient monitor measuring 10.6 in x 8.6 in x 6.5 in (26.5 cm x 21.8 cm x 16.5 cm) and weighing 10.8 lb (4.9 kg) without printer, cable, and accessories. Its carrying handle is designed for instrument transport while battery-powered monitoring continues.

The optional printer is installed within the case, adding 0.9 lb (0.4 kg) to the monitor weight.

Mounting attachments are provided on the case for use with an optional GCX mounting system. Refer to OPTIONAL ACCESSORIES section, page 123.

Figure 3: NPB-4000/C Patient Monitor

Features

ELECTRICAL

The NPB-4000 is powered by an internal battery pack that provides 4 hours of monitoring from fully charged batteries (typical, performance is at 25º C, with no printing, and one NIBP measurement every 15 minutes). The batteries are continuously recharged when AC or DC power is connected to the monitor.

The NPB-4000C is powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries (typical, performance is at 25º C, with no printing, and one NIBP measurement every 15 minutes). The batteries are continuously recharged when AC or DC power is connected to the monitor.

Battery charging is indicated by front panel green LCDs. Two LCDs are used, one for AC and one for DC. When operating on batteries, a battery “gauge” icon in the lower part of the display indicates the battery charge condition.

A warning message appears on the screen and an audible alarm sounds when the remaining battery power is only enough for 15 minutes of operation. The user should connect the monitor to an external power source to avoid loss of patient monitoring action.

External power sources may be connected, disconnected, and reconnected without interrupting the monitoring action.

DISPLAY

The NPB-4000 monitoring screen is a monochrome LCD display that shows all graphic and numeric patient information as well as alphanumeric status conditions and warning messages.

The NPB-4000C monitoring screen is a color LCD that shows all graphic and numeric patient information as well as alphanumeric status conditions and warning messages.

The graphics, text, and numeric information are grouped into areas through which the user interacts to control the monitoring functions and elements of the screen information.

Control Knob and Menus

The Control Knob provides user interaction with the display and the monitor functions.

Features

Rotating and pressing the knob allows a user to navigate and make changes to the display elements and monitor functions. Details of this interactive operation are described in the Display & Operation section, page 29.

AUXILIARY OUTPUTS

The NPB-4000/C monitor exports trend data via an RS-232 I/O port. The port also provides the capability for initiating a Nurse Call upon alarm. Refer to the RS-232 INTERFACE section, page117, for additional information.

The monitor generates a defibrillator synchronization signal, Defib Sync. The Defib Sync signal is available at the monitor rear panel. Refer to the DEFIB SYNC OUTPUT section, page

122.

OPTIONS AND ACCESSORIES

Refer to the OPTIONAL ACCESSORIES section, page 123, for descriptions of the monitor’s options and accessories.

Rotate

Press

[THIS PAGE INTENTIONALLY LEFT BLANK]

SETUP and USE

Unpacking and Inspection Power Cable Connections Measurement Cable Connections Power On and Self Test

WARNING: The NPB-4000/C is a prescription device and is to be operated by qualified personnel only.

WARNING: In the USA, do not connect to an electrical outlet controlled by a wall switch because the device may be accidentally turned off.

WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

WARNING: Do not use the NPB-4000/C patient monitor to monitor neonates.

CAUTION: If the NPB-4000/C is to be stored for a period of 2 months or longer, notify service personnel to remove the battery from the monitor prior to storage. Recharge the battery when the battery has not been recharged for 2 or more months.

CAUTION: Follow local government ordinances and recycle instructions regarding disposal or recycling of device components, including batteries.

UNPACKING AND INSPECTION

The NPB-4000/C patient monitor is shipped in one carton. Examine the carton carefully for evidence of damage. Contact the carrier immediately if any damage is discovered.

Retain all packing material. Refer to the Operator Maintenance and Troubleshooting section, page 103, for instructions on returning damaged items.

Setup and Use

POWER CABLE CONNECTIONS

AC Power

Ensure that the AC outlet is properly grounded and of the specified voltage and frequency (100-240 VAC, 50-60 Hz). Connect the AC power cord to the monitor rear panel connector identified with the AC power icon. See Figure 2, page 13. Use only a Nellcor supplied power cord. If in doubt about the integrity of the grounding of the AC power source, the monitor must be operated from its internal battery.

DC Power

Connect an external DC power source (10 to 16 volts DC) to the monitor rear panel connector identified with the DC power icon. See Figure 2, page 13. Use only a Nellcor DC input cable. The user must ensure that connection to the external DC supply meets all applicable safety codes.

MEASUREMENT CABLE CONNECTIONS

WARNING: Do not lift the monitor by the sensor cables, blood pressure hose, or power cord because the cable, lead, or cord could disconnect from the monitor, causing the monitor to drop on the patient.

ECG Cable and Leads

Use only a Nellcor CE-10 ECG cable and LE-Series ECG leads with the NPB-4000/C or, or an ECG cable and leads recommended by Nellcor Technical Services.

Connect the cable to the front panel connector marked with the ECG icon. See Figure 1, page 7, and refer to Table 1, page 8.

Connect leads to the patient as described in the ECG Monitoring section, page 55.

NIBP Hose and Cuff

Use only a Nellcor SHBP series hose and SCBP-Series cuff with the NPB-4000/C, or a hose and cuff recommended by Nellcor Technical Services.

Refer to the NIBP Monitoring section, page 65. Select the appropriate size cuff for the patient. Apply the cuff to the selected limb. Connect the hose to the front panel connector marked with the NIBP icon. See Figure 1, page 7, and refer to Table 1, page 8.

SpO2 Cable and Sensor

Use only Nellcor sensor extension cables and SpO2 sensors with the NPB-4000/C.

Setup and Use

Refer to the SpO appropriate sensor for the patient and desired application. Apply the sensor to the selected site. Connect the sensor to the cable, and connect the cable to the front panel connector identified with the SpO page 8.

Temperature Probe

The monitor uses YSI Series 400-compatible temperature probes. Insert the plug into the compatible jack on the monitor front panel marked with the temperature icon. See Figure 1, page 7, and refer to Table 1, page 8. Refer to Temperature

Monitoring section, page 115 for details.

2 Monitoring section, page 73. Select an

icon. See Figure 1, page 7, and refer to Table 1,

Setup and Use

POWER ON AND SELF-TEST

WARNING: If you do not hear the POST (power on self-test) pass tone, do not use the monitor.

WARNING: Disconnect the NPB-4000/C and sensors during magnetic resonance imaging (MRI) scanning. Use during MRI may cause burns or adversely affect the MRI image or the monitor’s accuracy

CAUTION: If any indicator or display element does not light, do not use the monitor. Instead, contact qualified service personnel, your local Nellcor representative, or the Nellcor’s Technical Services Department.

Note: The battery may be discharged upon receipt. It will be

fully charged after the first 8 hours the monitor is connected to an AC or DC power source.

Internal batteries that are charged by NPB-4000/C connection to external AC or DC sources supply the monitor power. The front panel display indicates the status of external power sources, as summarized in Table 6.

Table 6: Battery Charging Front Panel Indications

External Power

Front panel Indications

Connections

AC source AC icon lighted

DC source DC icon lighted

None Battery “gauge” appears in display.

No LED lit

After patient sensors are connected to their input cables, turn the monitor ON by pressure the front panel On/Standby switch. Audible feedback after pressing a front panel switch indicates that the monitor is processing the action.

Setup and Use

A copyright screen appears while the NPB-4000/C runs a set of self-diagnostic test routines. See Figure 4. The copyright screen displays the version of software installed in your unit. Call Nellcor’s Technical Services for the latest applicable software and to inquire about software updates.

Figure 4: Copyright Screen

After power-up diagnostics are completed successfully, the NPB-4000/C initiates monitoring operation. If no leads have been connected to the patient, the display appears similar to that shown in Figure 5.

/min

0.5

SpO2

( )

NIBP Ð Blocked Hose

Adult 2/14/95 16:34:36

SpO2

( )

mmHg

( )

/min

Figure 5: Typical Screen for No Patient Leads

180

Setup and Use

When the monitor detects valid signals a typical presentation with two real-time waveforms and a tabular trend appears. See Figure 6.

/min

0.5

SpO

mV cm

SpO

mmHg

TREND - 2/14

Figure 6: Typical Screen, Valid Monitored Signals

( )

NIBP HB SpO2 RR TTime

140/90(97) 82 95 11 37.616:17:05

Adult 2/14/95 16:34:36

If the ON/Standby switch is pressed when in the monitoring mode, the monitor is placed in the Standby mode, in which:

• The display is blanked

• Trend data taken during the monitoring mode

remains stored in memory

• No further monitoring takes place

• Battery charging continues if the monitor is

connected to an AC or DC power source

/min

140/90

(106)

37.8

180

SET DATE AND TIME

This procedure will enable you to set the date and time displayed on the screen and printed on the reports. Setting the date and time is accomplished by rotating and pressing the control knob.

Note: Read all procedure steps before trying to make any

changes. The display will return to the normal display screen if the knob is not rotated or pressed for 20 seconds.

Setup and Use

1. Rotate the knob to highlight the date time box. A dark border appears around the frame.

2. Press the knob. Date/Time menu appears.

3. Rotate the knob to highlight Date Format.

4. Press the knob. The date formats appear.

5. Rotate the knob to highlight: mm/dd/yy or dd/mm/yy.

6. Press the knob. The highlighted format appears after the Date Format menu entry.

7. Rotate the knob to highlight Set Date.

8. Press the knob. A date appears.

9. Rotate the knob to highlight the section of the date to be changed.

10. Press the knob. Selects the parameter to be changed.

11. Rotate the knob until the desired number is displayed.

12. Press the knob. The desired number is entered into the monitor.

13. Repeat steps 9 through 12 until the desired date is entered.

14. Rotate the knob to highlight Return.

15. Press the knob. The display returns to the Date/Time menu.

16. Rotate the knob to highlight Set Time.

17. Press the knob. A time appears.

18. Rotate the knob to highlight the section of the time to be changed.

19. Press the knob. Selects the parameter to be changed.

20. Rotate the knob until the desired number is displayed.

21. Press the knob. The desired number is entered into the monitor.

22. Repeat steps 18 through 21 until the desired time is entered.

23. Rotate the knob to highlight Return.

24. Press the knob. The display returns to the Date/Time menu.

25. Rotate the knob to highlight Return.

26. Press the knob. The display returns to the normal monitoring screen.

[THIS PAGE INTENTIONALLY LEFT BLANK]

DISPLAY and OPERATION

The Display Configuration Controlling Monitor Operation and Display Elements

WARNING: The NPB-4000/C is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

WARNING: Each time the monitor is used, check alarm limits to ensure that they are appropriate for the patient being monitored.

WARNING: The nurse call feature should not be used as the primary source of alarm notification. The audible and visual alarms of the monitor, used in conjunction with clinical signs and symptoms, are the primary source for notifying medical personnel that an alarm condition exists.

THE DISPLAY CONFIGURATION

General

The display in Figure 7, page 30, is of a typical monitoring condition with three waveforms. The display is divided into a number of areas that are further subdivided into frames.

Display and Operation

/min

Color Display

The NPB-4000C patient monitor has a color liquid crystal display (LCD). The NPB-4000C LCD performs the same functions as the NPB-4000 LCD except that the display is in color. The colors are function related as shown in Table 7, page

31.

0.5

SpO

mV cm

SpO

180

37.8

mmHg

140/90

( )

NIBP - Blocked Hose

Adult 2/14/95 16:34:36

(106)

/min

Figure 7: A Typical Monitoring Screen

1. Numeric Area

2. Gauge Indicates Monitor is Using Only Battery

3. Message/menu area

4. Graphic Area

Note: The Contrast Adjust switch is implemented differently on

the NPB-4000 and the NPB-4000C. See Table 2, page 8.

Table 7: NPB-4000C Color Description

Function Color

ECG/Heart Rate Green

Display and Operation

SpO

NIBP Red

Respiratory Yellow

Temperature Orange

General Background Black or white

Medium Priority Alarm Flash Yellow (numeric

High Priority Alarm Flash Red (numeric

Battery Icon (normal) Green

Battery Icon (low battery) Yellow or Red (refer to

Numeric Area/Frames

The right-hand area of the display is the numeric area and contains six frames in which numeric values are displayed. Five of the frames contain suitable icons relating the values to monitored patient parameters; the sixth frame displays time and date.

Blue

depending on the color set selected by the Contrast Adjust switch.

frame background)

Table 8, page 33)

Numeric Frames

From top to bottom, the six numeric frames display the following:

• Heart Rate in beats/minute

• SpO

• NIBP Systolic/Diastolic (Mean Arterial Pressure) in mmHg

• Respiration Rate in breaths/minute

in percent saturation

Display and Operation

• Temperature in ° C or ° F

• Date and Time: mm/dd/yy or dd/mm/yy for date, and

24-hour format for time

The numeric frames always represent the icon-indicated vital signs and may not be reassigned, resized, or resequenced.

Graphics Area/Frames

The upper left area is called the graphics area and it contains three equally sized graphics frames in which real-time physiological waveforms, graphical trend, or tabular trend data are displayed.

When the ECG leads are connected to the patient, the top graphics frame always displays the ECG waveform. In the remaining two graphic frames, the user may select available waveforms or trend. The waveforms or trends appearing in the frames at power-up are factory set, but may be changed by qualified service personnel with passcode access.

When a menu setup is selected, a single menu frame in which submenus and selectable parameter values are displayed for user selection replaces the lower two graphics frames.

Message/Menu Frames

The area below the graphics area is called the Message/Menu area. The upper of two frames in this area is reserved for messages. These are in simple language and describe alarm conditions. The message remains displayed until the problem is resolved, or it may be cleared by pressing the front panel Alarm Silence switch. If there is more than one message, each is displayed for 1 second.

The lower of the two sets of frames in this area is used to show status icons and to provide menu choices.

Status Icons

Battery Icon:

Display and Operation

The Battery-in-Use icon (at the right end of the frames) appears whenever the monitor is operating on battery power alone. The icon is in the form of a “gauge” providing a graphic indication of remaining battery power. In the NPB4000, the icon flashes when the monitor detects low battery power. In the NPB-4000C, the icon is displayed as indicated in Table 8.

Table 8: NPB-4000C Battery Icon

Operating Mode:

Menu Icons

There are three icons in the Menu portion of the Message/Menu area: Alarm/Limits, Big Numbers, and Setup.

Alarm/Limits Icon:

Number of Bars

Color Used Behavior

Illuminated

3, 4, or 5 Green Constant display

2 Yellow Constant display

1 Red Constant display

0 Red Icon flashes and

message displayed

The operating mode “Adult” is indicated at the left of the battery gauge. The Adult operating mode accommodates both adult and pediatric patients.

When selected, a menu appears in Frames 2 and 3 of the Graphics Area. The user may view the current alarm limit settings, or may modify them.

Display and Operation

Big Numbers Icon:

When selected, a Big Numbers display format is generated, and five numeric frames of monitored patient vital signs are enlarged and replace the lower two graphic frames and the six numeric frames. See Figure 8. The time value is moved to the upper right of the screen.

Setup Icon:

When selected, a menu of general-purpose parameters is presented in the graphics area. The user activated Nurse Call signal, if connected. Qualified service personnel can change the Power-Up Default settings of the monitor by using the Enter Power-Up Default Menu. This function is passcode protected, and is further described in Power-Up Default Settings section, page 35.

0.5

/min

SpO

16:34

mmHg

Big Numbers Screen

The Big Numbers screen provides numeric values that can be read at a distance, and may be more useful to the clinician. Use of the Big Numbers presentation has the following characteristics.

/min

( )

140/90

(106)

180

Figure 8: Big Numbers Screen

Adult

97 14

37.8

• Selecting the “Big Numbers” icon from the monitoring screen makes access to Big Numbers; Big Numbers is not a power-up default choice.

• One press or rotation of the knob causes the NPB-4000/C to revert to the monitoring screen.

• Any alarm condition causes the NPB-4000/C to revert to the monitoring screen.

• No changes to the display are possible.

• The top graphic frame remains identical in size and

content, whether in normal monitoring screen or Big Numbers screen.

• Single-function buttons in the switch panel operate normally, with one exception: if Alarm Suspend is invoked, the normal monitoring screen immediately replaces Big Numbers.

Power-Up Default Settings

Each time the NPB-4000/C is turned on, a number of settings are automatically configured. These settings include alarm limits, ECG lead selection, type of waveforms and/or trends presented in the graphic frames, heart rate tone source, and others. These settings are known as power-up defaults. Each power-up default is set at the factory; however, qualified service personnel may change the factory-set defaults. Instructions for making these adjustments are found in the NPB-4000/C service manual.

Display and Operation

CONTROLLING MONITOR OPERATION AND DISPLAY ELEMENTS

Except for actions initiated by pressing a front panel switch, control of the NPB-4000/C patient monitor is accomplished by using the knob to interact with the appropriate area on the display.

The procedure is the same for all operational and display changes:

1. Rotate the knob to highlight item to be changed.

Display and Operation

2. Press the knob to make the change

The monitoring screen is, in effect, a high-level menu. Highlighting an area on the monitoring screen by rotating the knob, and selecting it by pressing the knob, will bring up a Level 1 menu that relates to that screen area. Once in the Level 1 menu, the same action-pair of rotating and pressing the knob to highlight and select a menu item takes place. The response may be effective immediately or may bring up a Level 2 menu that “pops up” on the screen without removing the Level 1 menu.

A knob time-out of 20 seconds (no knob action) returns the display to the monitoring screen.

Example of a Change Operation

To change the sweep speed of the ECG waveform presented in the top graphics frame:

1. ROTATE the knob to highlight the ECG graphics frame. A dark border appears around that frame.

Rotate

Press

2. PRESS the knob. The Level 1 menu appears.

3. ROTATE the knob to highlight Sweep Speed. It appears in reverse video.

4. PRESS the knob. A Level 2 menu appears, and the current value is highlighted in reverse video.

5. ROTATE the knob to highlight a different value in the list.

6. PRESS the knob. The waveform speed is changed to the new sweep speed.

7. ROTATE the knob to highlight Return.

8. PRESS the knob to return to the normal monitoring screen.

Figure 9, page 37, illustrates the process described above.

Display and Operation

/min

0.5

ECG WA VEFORM MENU

Lead Select (II)

Sweep Speed (25 mm/s)

Size (0.5 Mv/cm) Pacer Detect (Off) Extended Low Frequeny Range (Off)

ECG Waveform SpO2 Waveform Respiration Waveform Tabular Trend HR Graphical Trend SpO2 Graphical Trend NIBP Grapical Trend RR Graphical Trend Temperature Graphical Trend

Return

12.5 mm/s 25 mm/s

50 mm/s

Adult 2/14/95 16:34:36

Figure 9: Highlighted ECG Graphic;

Level 1 and Level 2 Menus

1. Level 2 Menu

4. Level 1 Menu Graphic Type

2. Closes Menu 5. Highlighted and Selected ECG Waveform

3. List of Other Graphic

Types

Items

SpO

mmHg

140/90

(106)

/min

for Current

180

37.8

Note: Although other graphic types are listed as possible menu

choices for the top graphics frame, they are not available when the ECG cable is connected. If an attempt is made to select another graphic waveform, the following message block appears “Selection not available.”

Cascading Waveforms

If a waveform already displayed in a graphics frame is also selected for another frame, then the two frames form a cascaded waveform, effectively presenting a sample over twice the time interval of one frame.

The second half of the cascade may be in any frame, and need not be placed directly under the first frame.

Display and Operation

Change Operations Described in Tables

Figure 10 shows an expanded view of a SpO2 waveform frame. To make a change to this waveform, or put a different type of graphic in its place, rotate the knob until the SpO frame is highlighted, then press the knob. The relevant menu appears in the second and third graphic frames.

waveform

Table 9, page 39 details the SpO

0.5

SpO2

( )

Figure 10: SpO2 Screen

SpO

1. SpO

2. SpO

( )

NIBP Ð Blocked Hose

Waveform

Icon

waveform menu.

/min

SpO

mmHg

140/90

(106)

/min

Adult 2/14/95 16:34:36

37.8

180

Display and Operation

Table 9: SpO2 Screen Menus

Level 1 Menu Screen Level 2 Menu or Response

Title: SpO2 WAVEFORM MENU

Sweep Speed 12.5 mm/s, 25 mm/s, 50 mm/s

Other graphic type choices:

ECG Waveform

Waveform

>SpO Respiration Waveform Tabular Trend HR Graphical Trend SpO

Graphical Trend

NIBP Graphical Trend Temperature Graphical Trend

Return

In this example, the only variable setting for the SpO2 waveform is Sweep Speed.

Other graphic types may be selected, as listed. An arrow indicates the current graphic type. The list is the same for all graphic menus.

The final selection is Return to monitoring screens.

In this example, there is only one variable parameter (sweep speed. The possible sweep speeds are 12.5, 25, or 50 mm/s.

Note: Table 9, page 39, incorporates a type-font convention to

distinguish what appears on the screen and any descriptive phrase for segments of the information. The screen text is presented in bold font; the descriptive text is in Italics or regular font.

No Level 2 menu for these items; selection of a new graphic type immediately causes the title and the first menu items to update to reflect the new choice.

Exits Level 1 menu immediately, returns to Monitoring Screen

This presentation of the screen frame and the associated tables of menu choices will be used throughout this manual to summarize the monitoring operations and screen presentations.

[THIS PAGE INTENTIONALLY LEFT BLANK]

ALARMS and LIMITS

General Alarm Priority Loss-of-Monitoring Alarm Visual Alarm Indicators Audible Alarm Indicators Setting and Changing Alarm Limits Using the Alarm/Limits Screen Auto-Set Alarm Limits Using the Numeric Frame Alarm Limits and Factory-Set Default Values Alarm Silence Switch Alarm Suspend

GENERAL

WARNING: Do not silence the audible alarm or decrease its volume if patient safety could be compromised.

WARNING: Each time the monitor is used, check alarm limits to ensure that they are appropriate for the patient being monitored.

WARNING: The nurse call feature should not be used as the primary source of alarm notification. The audible and visual alarms on the monitor, used in conjunction with clinical signs and symptoms, are the primary source for notifying medical personnel that an alarm condition exists.

When the monitor detects certain conditions that require user attention, the NPB-4000/C monitor enters an alarm state. The monitor response is indicated by:

• Visual alarm indicators

• Audible alarm indicators

• Print-on-alarm (if printer installed)

• Identification of out-of-limit vital signs in trend data

• Nurse-call signal (if connected and enabled)

Alarms and Limits

ALARM PRIORITY

The monitor’s visual and audible responses to a detected alarm depend on the priority of the alarm; High, Medium, or Low.

A higher priority alarm will supersede a lower priority alarm. The three categories of alarms are summarized in the following paragraphs. The text in bold font indicates the message shown on the screen. Limit alarms do not have messages.

High Priority:

Asystole (4 seconds have passed with no heart beats from ECG, preceded by detecting valid ECG-derived heart rate data.)

Loss of Pulse from SpO

Medium Priority:

High/Low Heart Rate limits violated

High/Low SpO

High/Low Sys./Dia./MAP blood pressure limits violated

High/Low Respiration Rate limits violated

High/Low Temperature limits violated

Loss of Respiration Signal

Low Priority:

ECG Leads Off

Cable/Sensor Disconnect

SpO

Loss of Pulse from SpO

Low Battery (alarm commences when the NPB-4000/C has at

least 15 minutes of operating time remaining)

Temperature Probe Disconnect

NIBP - No Cuff

NIBP - Blocked Hose

2 (and no valid ECG)

limits violated

2 (but there is valid ECG)

NIBP - Artifact

NIBP - Time-Out

Printer Out of Paper

LOSS-OF-MONITORING ALARM

In the event of a high, medium, or low level alarm, the NPB-4000/C continues to perform monitoring functions. The alarms are designed to alert users of patient or instrument conditions that warrant immediate attention.

A special class of alarms, loss-of-monitoring, occurs when the NPB-4000/C cannot continue to monitor because of an error condition or shutdown because of a low-battery condition.

When a loss-of-monitoring alarm occurs, the NPB-4000/C emits a continuous tone until the Alarm Silence switch is pressed.

WARNING: Neither the print-on-alarm nor the nurse-call signal will be initiated when the monitor detects a loss-ofmonitoring state.

VISUAL ALARM INDICATORS

When an alarm occurs, the NPB-4000/C responds with visual alarm indications. The flashing rates for the three categories of alarms are shown in Table 10. The NPB-4000C alarms use flashing colors to indicate high and medium priority alarm. Refer to Table 7, page 31.

Alarms and Limits

Table 10: Visual Alarm Flashing Rates

Alarm Category Flashing Rate

High Priority Two flashes in 1 second

Medium priority One flash in 2 seconds

Low priority Constant (on) (non-flashing)

When a low priority alarm occurs, a non-flashing alarm message appears in the message area. If more than one low priority alarm is present, the alarm messages “rotate”. On the NPB-4000C, the numeric frame background color will change to a solid yellow for a low priority alarm.

Alarms and Limits

When a medium priority alarm is activated because a parameter is outside its alarm limits, the out-of-limit numeric value and the bell icon in the corresponding Numeric Frame flash at the medium priority rate. Only the numeric frame background color will flash yellow for a medium priority alarm in the NPB-4000C.

When the high-priority Asystole alarm occurs, the heart rate numeric value and the corresponding bell icon flash at the high priority rate. Only the numeric frame background color will flash red for a high priority alarm in the NPB-4000C. A nonflashing Asystole message appears in the message area and will override any other messages which may be present (there is no message “rotation” in this instance).

When the high-priority loss of pulse from SpO ECG) alarm occurs, the SpO (which are “0”) and the corresponding bell icons flash at the high priority rate. Only the numeric frame background color will flash red for a high priority alarm in the NPB-4000C. A non-flashing Loss of Pulse from SpO message area and will override any other messages that may be present (there is no message “rotation” in this instance).

AUDIBLE ALARM INDICATORS

The audible alarm has different tone pitch and on-off beep patterns for each alarm priority. Refer to Table 11.

Table 11: Audible Alarm Characteristics

Alarm Category Tone Pitch Beep Rate

High priority ~930 Hz ~ 3 beeps per sec.

Medium priority ~750 Hz ~ 1 beep per sec.

Low priority ~500 Hz ~ 1beep per 4 sec.

Loss-of-monitoring ~3300 Hz continuous

Note: Visual alarm indicators cannot be suspended or removed.

Audible alarms may be decreased in volume or silenced as described in the operational instructions that follow.

(with no valid

and heart rate numeric values

message appears in the

WARNING: Do not silence the audible alarm or decrease its volume if patient safety could be compromised.

SETTING AND CHANGING ALARM LIMITS

When the NPB-4000/C is first turned on, alarm limits are set to the power-up default values. Qualified service personnel can change power-up default alarm limits, as described in the NPB-4000/C service manual.

The user can change alarm limits from default values, if necessary, as described below. These changes made by the user will remain in effect until they are modified again, or until the NPB-4000/C is turned off.

WARNING: Each time the monitor is used, check alarm limits to ensure that they are appropriate for the patient being monitored.

Alarm limits may be set in two ways:

• Via interaction with a numeric frame that presents currently measured values of a vital sign, or

• Via interaction with the Alarm/Limits Screen that presents the limits in all measured parameters at one time.

Alarms and Limits

USING THE ALARM/LIMITS SCREEN

Rotate the knob until the Alarm/Limits icon (bell and limits symbol) in the lower left of the monitor screen is highlighted. Press the knob. The Alarm/Limits menu is displayed. The monitor’s alarm limits currently in effect for all monitored parameters are displayed at one time.

Figure 11, page 46, illustrates a typical Alarm/Limits screen.

Alarms and Limits

/min

0.5

ALARM /LIMITS MENU

Return

Operation of the Alarm/Limits Menu is summarized in Table 12.

Selected Level 1

Item

Return

mV cm

Print-on-Alarm (On)

/min

150 100 200 150 100 50 38.5 60

Alarm Volume (6) Silence Period (90 s)

SYS

SpO

90 130 100 60 5 36.0

MAP

( )

DIA

Adult 2/14/95 16:34:36

SpO2

( )

mmHg

140/90

(106)

/min

Figure 11: Alarm/Limits Screen Presentation

Table 12: Alarm/Limits Menu

Level 2 Screen Menu, or

Monitor Response When Selected

Exit menu immediately, returns to Monitoring Screen

180

37.8

Auto-Set Limits Make No Change to Limits: Limits remain for

all parameters as shown.

Auto-Set Now: New limits are calculated according to formulas described in Table 13, page 50, and replace those on the screen.

Table 12: Alarm/Limits Menu

Alarms and Limits

Selected Level 1

Item

Level 2 Screen Menu, or

Monitor Response When Selected

Print-on-Alarm On, Off: Optional printer required. Causes a

20-second “snapshot” printout each time a high or medium priority out-of-limits alarm condition occurs. The 20 seconds includes the information from 10 seconds prior to the alarm event. Out-of-limits values are identified in the printout by bracketing them between triangular brackets.

An alarm-initiated printout will interrupt any other snapshot or trend printing that may be in process. The interrupted printing will not resume after the alarm-initiated snapshot has been printed.

HR Upper/Lower Limits

Variable: When selected by rotating the knob to

highlight the desired limit, pressing the knob enables its subsequent rotation to cycle through possible limit values that appear in place. Pressing knob places the displayed limit in effect.

HR Audible Silence

On/Off: (Bell icon) Toggling action. When OFF

is selected, permanently silences the audible alarm for HR limit violations. Bell icon is “slashed” when OFF is selected.

SpO2 Upper/Lower Limits

SpO2 Audible Silence

Variable: When selected by rotating knob to

highlight the desired limit, pressing knob enables its subsequent rotation to cycle through possible limit values that appear in place. Pressing knob places the displayed limit.

On/Off: (Bell icon) Toggling action. When Off is selected, permanently silences the audible alarm for SpO

limit violations. Bell icon is “slashed”

when Off is selected.

Alarms and Limits

Table 12: Alarm/Limits Menu

Selected Level 1

Item

SYS Upper/Lower Limits

DIA Upper/Lower Limits

MAP Upper/Lower Limits

NIBP Audible Silence

Level 2 Screen Menu, or

Monitor Response When Selected

Variable: When selected by rotating knob to

highlight the desired limit, pressing knob enables its subsequent rotation to cycle through possible limit values that appear in place. Pressing knob places the displayed limit in effect.

Variable: When selected by rotating knob to highlight the desired limit, pressing the knob enables its subsequent rotation to cycle through possible limit values that appear in place. Pressing knob places the displayed limit in effect.

On/Off: (Bell icon) Toggling action. When OFF is selected, permanently silences the audible alarm for NIBP limit violations. Bell icon is “slashed” when OFF is selected.

RR Upper/Lower Limits

RR Audible Silence

On/Off: (Bell icon) Toggling action. When Off is selected, permanently silences the audible alarm for respiration limit violations and loss of respiration signal alarm. Bell icon is “slashed” when Off is selected.

Table 12: Alarm/Limits Menu

Alarms and Limits

Selected Level 1

Item

Temperature Upper/Lower Limits

Variable: When selected by rotating knob to

highlight the desired limit, pressing the knob enables its subsequent rotation to cycle through

Level 2 Screen Menu, or

Monitor Response When Selected

possible limit values that appear in place. Pressing knob places the displayed limit in effect.

Temperature Audible Silence

On/Off: (Bell icon) Toggling action. When Off

is selected, permanently silences the audible alarm for HR limit violations. Bell icon is “slashed” when Off is selected.

Alarm Volume 1, 2, 3, 4, 5, 6, 7, 8, 9: Value increases in eight

5 dBA increments from lowest value of 45 dBA in Step 1 to a maximum of 73 dBA in step 9.

If the Alarm Silence switch on the front panel is pressed while setting is changed, the alarm will sound at the volume selected.

Silence Period 30 s, 60 s, 90 s, 120 s: Time is indicated in

seconds.

Pressing the front panel Alarm Silence switch temporarily silences alarms for the time indicated in the Silence Period menu item. Alarm state(s) in effect at the end of the pre-set interval cause the audible alarm to sound.

Pressing the Alarm Silence switch a second time (while the silence interval is still in effect) ends the interval immediately.

On the NPB-4000, silencing audible alarms does not affect visual alarm indications.

On the NPB-4000C, the visual indication of low priority alarms is cleared by a single press of the Alarm Silence switch.

Alarms and Limits

AUTO-SET ALARM LIMITS

The Auto-Set Limits function allows the user to quickly set alarm limits based on the patient’s current vital sign values. When the Auto-Set Limits item is selected from the Alarm/Limits Menu, the NPB-4000/C takes each currently measured vital sign and applies a calculated offset to each value to generate the new upper and lower alarm limits. Refer to Table 13.

Table 13: Auto-Set Limits Formulas

Parameter Lower Limit Upper Limit

Heart Rate (HR) (HR) x 0.75 or 30

BPM (whichever is greater)

(HR) x 1.5 or 250 BPM (whichever is smaller)

NIBP SYS (SYS) (SYS) x 0.68 + 10 (SYS) x 0.86 + 38

NIBP DIA (DIA) (DIA) x 0.68 + 6 (DIA) x 0.86 + 32

NIBP MAP (MAP) (MAP) x 0.68 + 8 (MAP) x 0.86 + 35

Temperature º C (T) (T) - 0.5 (T) + 0.5

Temperature º F (T) (T) - 0.9 (T) + 0.9

SpO

Make same as SpO power-up default lower limit.

Make same as SpO

power-up default upper limit.

Respiration Rate (RR) (RR) x 0.5 (RR) x 1.5

USING THE NUMERIC FRAME

Alarm limits for interacting with the numeric frame for that parameter may set any one physiological parameter. These are described in the chapters covering individual parameter monitoring.

ALARM LIMITS AND FACTORY-SET DEFAULT VALUES

Table 14, page 51, describes the range and increment values that are used to change alarm limits. The values set at the factory for each parameter are also shown.

Alarms and Limits

Table 14: Alarm Limits Ranges and Factory-Set Limits

Parameter Upper Limits

Range/Steps

NIBP 100 to 240

mmHg 5 mmHg steps

NIBP DIA 80 to 180

mmHg 5 mmHg steps

NIBP MAP 90 to 200

mmHg

Temp º C 33º C to 41º C

0.1º C steps

Temp º F 91º F to 106º F

0.1º F steps

Heart Rate 30 to 250 BPM

5 BPM steps

Respiration Rate

3 to 150 BPM 1 BPM steps

SpO2% 20% to 100%

1% steps

Factory

Defaults

200 mmHg

Lower Limits

Range/Steps

60 to 150 mmHg 5 mmHg steps

160 mmHg

20 to 120 mmHg 5 mmHg steps

180 mmHg

30 to 130 mmHg 5 mmHg steps

38º C 33º C to 41º C

0.1 º C steps

100.6º F 91º F to 106º F

0.1º F steps

170 BPM 30 to 250 BPM

5 BPM steps

40 BPM 3 to 150 BPM

1 BPM steps

100% 20% to 100%

1% steps

Factory

Defaults

70 mmHg

50 mmHg

60 mmHg

36º C

96.6º F

40 BPM

4 BPM

85%

Note: High limits cannot be set less than or equal to the low

limit. Low limits cannot be set greater than or equal to the high limit.

ALARM SILENCE SWITCH

WARNING: Do not silence the audible alarm or decrease its volume if patient safety could be compromised.

Alarms and Limits

Temporarily silencing the audible alarm is accomplished by pressing the Alarm Silence switch on the front panel. This action silences ALL audible alarms for a user-controlled preset interval. Refer to Silence Period in Table 12, page 46. A reverse-video, slashed-bell icon appears in each numeric frame during a temporary silence period.

ALARM SUSPEND

If the Alarm Silence switch is depressed and held for 2 seconds, the Alarm Suspend condition is initiated. Pressing the Alarm Silence switch terminates the Alarm Suspend condition.

When Alarm Suspend is initiated, ALL audible alarms and print-on-alarm functions are disabled. Visual alarms, nurse-call signal, and identification of out-of-limits vital signs in trend memory continue to function. Graphic Frames 2 and 3 are replaced with a prominent warning graphic indicating that the monitor is in Alarm Suspend. See Figure 12.

/min

0.5

ALARM SUSPEND

SpO2

mmHg

140/90

(106)

180

( )

/min

Figure 12: Alarm Suspend Screen

Adult 2/14/95 16:34:36

WARNING: If an alarm condition (except those leading to a loss-of-monitoring alarm) occurs while in the Alarm Suspend state, the only alarm indication at the monitor will be visual displays related to the alarm condition.

37.8

Alarms and Limits

During Alarm Suspend, monitoring continues for all parameters; the numeric values and the top Graphic Frame (typically ECG waveform) continue to operate normally. Trend memory operates normally. The single-function buttons continue to operate normally. No Level 1 or 2 menus may be invoked while in Alarm Suspend State. Access to the Big Numbers screen is denied while in the Alarm Suspend condition.

[THIS PAGE INTENTIONALLY LEFT BLANK]

ECG MONITORING

General ECG Safety Information Setup Connections Controlling ECG Functions via Numeric Frame Controlling ECG Waveform via Graphic Frame

GENERAL

The process of depolarization and repolarization of the myocardium generates electric potentials that are sensed by ECG electrodes on the skin surface.

These electrodes are typically attached to the patient’s right arm, left arm, and left leg. The monitor processes and amplifies these signals and presents the ECG waveform on the screen.

In addition to the acquisition of the QRS complex, the circuitry performs a number of other functions:

• Computation and display of the heart rate in beats per minute

• Detection of a “lead off” condition if one of the electrode connections is disrupted

• Detection of the presence of pacemaker signals within the waveform complex of the ECG

• Generation of a synchronization pulse for external use with defibrillators. (The Defib Sync Output is available at a connector in the rear panel. Refer to the DEFIB SYNC OUTPUT section, page 122, for more details.)

• Selection by the user of an extended low frequency range of signal detection and processing

ECG SAFETY INFORMATION

ECG Monitoring

WARNING: Use only a Nellcor CE-10 ECG cable and LESeries ECG leads with the NPB-4000/C or an ECG cable and lead recommended by Nellcor’s Technical Services. Other ECG cables and leads may cause improper performance and/or provide inadequate protection during defibrillation.

WARNING: Ensure that conductive portions of the electrodes, leads, and cable do not come into contact with any other conductive parts.

WARNING: Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. Such transients may be minimized by proper electrode and cable placement, as specified in this manual and electrode directions for use.

WARNING: Do not use damaged ECG leads. Do not immerse ECG leads completely in water, solvents, or cleaning solutions because the connectors are not waterproof. Do not sterilize ECG leads by irradiation, steam, or ethylene oxide. Refer to the cleaning instructions in the directions for use for ECG leads.

WARNING: For pacemaker patients, the NPB-4000/C may continue to count pacemaker rate during occurrences of cardiac arrest or some arrhythmias. To reduce the likelihood of this, ensure that the Pacer Detect setting is ON in the ECG menu when monitoring such patients. Do not rely entirely upon the NPB-4000/C alarms. Keep pacemeaker patients under close surveillance.

WARNING: It is possible for the patient to receive a burn due to an improperly connected electrosurgical unit. Additionally, the monitor could be damaged or measurement errors could occur. Certain steps can be taken to mitigate against this problem, such as not using small ECG electrodes, selecting ECG electrode sites remote from the expected RF paths, using large electrosurgical return electrodes, and verifying that the electrosurgical return electrode is properly attached to the patient.

WARNING: ECG cables may be damaged if they are connected to a patient during defibrillation. Cables that have been connected to a patient during defibrillation should be checked for functionality before using again.

SETUP CONNECTIONS

Use only a Nellcor CE-10 ECG cable and LE-Series ECG leads with the NPB-4000/C or an ECG cable and leads recommended by Nellcor’s Technical Services.

1. Connect the ECG cable to the ECG input connector on the monitor front panel.

ECG Monitoring

2. Connect the ECG leads to the ECG cable.

3. Select the electrodes to be used. Use only one type of electrode on the same patient to avoid variations in electrical resistance. For ECG monitoring, Nellcor recommends the use of silver/silver chloride electrodes. When dissimilar metals are used for different electrodes, the electrodes may be subject to large offset potentials due to polarization, which may be severe enough to prevent obtaining an ECG trace. Using dissimilar metals may also increase recovery time after defibrillation.

4. Prepare the electrode sites according to electrode manufacturer’s instructions. See Figure 13, page 58, and Figure 14, page 58, for electrode placement configurations.

5. Attach the lead wires to the electrodes.

ECG Monitoring

6. Apply the electrodes to the patient as shown in either Figure 13, page 58, or Figure 14, page 59, using the color-code guide in Table 15, page 31.

7. If Standard ECG Lead Placement is used ( Figure 13), verify that the desired Lead Selection is active in the ECG waveform frame. Refer to Table 15. Lead II is best suited for most monitoring situations.

8. If Modified Chest Lead is used (Figure 14), verify that Lead II is active in the ECG waveform frame.

Right arm (RA) White Red

Left arm (LA) Black Yellow

Left leg (LL) Red Green

3 1

Table 15: ECG Lead Color Coding

Lead AHA IEC

Figure 13: Standard ECG Leads Placement

1 LA 2 LL 3 RA

ECG Monitoring

Table 16: ECG Lead Pairs (for Standard Leads Placement)

Lead-Select Option Electrode Differential

IRA ➞ LA

II RA ➞ LL

III LA ➞ LL

Figure 14: Modified Chest Lead (MCL1) Placement

(if using MCL1, select Lead II)

1 RA 2 LL 3 LA

ECG Monitoring

CONTROLLING ECG FUNCTIONS VIA NUMERIC FRAME

/min

0.5

SpO

mV cm

SpO

mmHg

( )

NIBP Ð Blocked Hose

/min

Adult 2/14/95 16:34:36

Figure 15: Heart Rate Display

1. Units of Measure 3. HR Source Icon

2. HR Value 4. HR Icon

Table 17: Heart Rate Menu

Level 1 Menu Level 2 Menu or Response

Title: Heart Rate Menu Heart Rate Tone Source SpO2, ECG

Heart rate limits Variable (refer to Table 13,

HR alarm silence icon On/Off

Return

140/90

(106)

180

/min

37.8

( )

page 50)

Exits Level 1 menu immediately, returns to Monitoring Screen

ECG Monitoring

The calculated heart rate may be derived from different sources, as shown by the icon in the frame: ECG, SpO

, or NIBP. The

NPB-4000/C automatically derives heart rate from ECG whenever a valid ECG signal is present. If ECG is not present, but SpO the SpO

is being monitored, the heart rate value is derived from

signal. If neither ECG nor SpO2 is available, heart rate

derived from NIBP will be displayed. If HR is derived from NIBP, that value will only be displayed for 3 minutes after the NIBP measurement, then the value is removed from the display.

A short pulse tone will sound, synchronous with each heartbeat. This heart rate tone may be derived from either of two sources: SpO

or ECG, as indicated in Table 17, page 60. When SpO2 is

the source, the pitch varies proportionally with changes in oxygen saturation, rising as SpO

increases toward 100%, and

falling as it decreases. If the source is ECG, the heart rate tone does not change pitch. The volume of the heart rate tone may be adjusted by pressing the front panel Heart Rate Tone Volume switch, then turning the knob.

CONTROLLING ECG WAVEFORM VIA GRAPHIC FRAME

When ECG leads are connected to the patient, the top graphic frame always displays the ECG waveform.

ECG Monitoring

/min

0.5

SpO2

mV cm

SpO

mmHg

( )

140/90

(106)

/min

( )

NIBP Ð Blocked Hose

Adult 2/14/95 16:34:36

0.5

mV cm

Figure 16: ECG Waveform

1. Lead Pair

2. Size Scale

3. Size Bar 1 cm

4. ECG Icon

180

37.8

The standard size bar, with a height of 1 cm, serves as a visual reference for the ECG waveform.

ECG Monitoring

Table 18: ECG Waveform Menu

Level 1 Menu Level 2 Menus or Response

Title: ECG WAVEFORM MENU

Lead Select I, II, III

Sweep Speed 12.5 mm/s, 25 mm/s, 50 mm/s

Size 0.5 mV/cm, 1 mV/cm, 2 mV/cm,

4 mV/cm

Pacer Detect On, Off

Extended Low Frequency Range On, Off

other graphic type choices:

>ECG Waveform SpO

2 Waveform

Respiration Waveform Tabular Trend HR Graphic Trend SpO

2 Graphical Trend

NIBP Graphical Trend RR graphical Trend Temperature Graphical Trend

Return

Extended Low Frequency Range

When Extended Low Frequency Range is On, the monitor provides better ST segment resolution. However, the increased bandwidth may result in low-frequency wander of the ECG baseline, so it is generally recommended that this feature be kept Off except when better ST segment resolution is specifically required.

No Level 2 menu for these items; selection of a new graphic type immediately causes the title and the first, menu items to update, reflecting the new choice.

Note: For consistency, the other

display choices are present, but in frame 1 they can not be selected as long as ECG leads are on patient.

Exits Level 1 menu, returns to Monitoring Screen

ECG Monitoring

Pacer Detect

Pacer detect should always be On for patients with pacemakers (refer to safety warning at beginning of chapter). When Pacer Detect is On, the NPB-4000/C detects and filters pacemaker-generated signals so that they will not be measured in determining a patient’s heart rate. Detected pacemaker signals will be displayed on the ECG waveform (screen and printout) as a positive-going spike. Monitoring of non-pacemaker patients is generally not affected when Pacer Detect is enabled; however, in some instances if the patient does not have a pacemaker, it may be desirable to turn the detection function Off so that artifacts in the waveform will not be mistaken for a pacemaker signal.

ECG Leads Off

The NPB-4000/C can determine when all three ECG leads are properly attached to the patient. Should one or more of the leads come off, or lose good electrical contact, after the monitor has established that all 3 leads are attached, a low-priority “ECG Leads Off” alarm will be issued, alerting the caregiver to remedy the problem.

Occasionally, electromagnetic “noise” may cause the ECG circuit to electrically “saturate”. If this condition occurs, the NPB-4000/C will issue an ECG Leads Off alarm. Occurrence is rare, and duration should be short. As soon as the condition ceases, the “ECG Leads Off” alarm will automatically clear.

NIBP MONITORING

General NIBP Safety Information Setup Connections NIBP Measurement Modes Controlling NIBP Functions via Numeric Frame

GENERAL

NIBP processing by the monitor uses the oscillometric measuring technique. A motorized pump inflates the cuff to initially blocking the flow of blood in the extremity. Then, under monitor control, the pressure in the cuff is gradually reduced, while a pressure transducer detects air pressure and transmits a signal to the NIBP circuitry.

When the cuff pressure is still above systolic pressure, small pulses or oscillations in the cuff pressure begin to be sensed by the transducer. As the cuff continues to deflate, oscillation amplitude increases to a maximum and then decreases. When maximum oscillation amplitude occurs, the cuff pressure at that time is measured as mean arterial pressure (MAP). The systolic and diastolic pressures are calculated based on analysis of the oscillation amplitude profile.

NIBP SAFETY INFORMATION

WARNINGS: Use only SCBP Series Blood Pressure Cuffs and the SHBP-10 Hose or a hose and cuff recommended by Nellcor’s Technical Services. Using other cuffs or hoses may result in inaccuracies.

WARNING: Inaccurate measurements may be caused by incorrect cuff application or use, such as placing the cuff too loosely on the patient, using the incorrect cuff size, or not placing the cuff at the same level as the heart, leaky cuff or hose, and excessive patient motion.

NIBP Monitoring

WARNING: The NPB-4000/C displays results of the last blood pressure measurement until another measurement is completed. If a patient’s condition changes during the time interval between measurements, the NPB-4000/C will not detect the change or indicate an alarm condition.

WARNING: As with all automatically inflatable blood pressure devices, continual cuff measurements can cause injury to the patient being monitored. Weigh the advantages of frequent measurement and/or use of stat mode against the risk of injury.

WARNING: In some cases, rapid, prolonged cycling of an oscillometric, noninvasive blood pressure monitor cuff has been associated with any or all of the following: ischemia, purpura, or neuropathy. Apply the oscillometric cuff appropriately, according to instructions, and check the cuff site and cuffed extremity regularly when blood pressure is measured at frequent intervals or over extended periods of time.

WARNING: Check the patient’s limb on which the cuff is applied to assure that circulation is not constricted. Constriction of circulation is indicated by discoloration of the extremity. This check should be performed at the clinician’s discretion at regular intervals based on the circumstances of the specific situation.

WARNING: Do not place the cuff on an extremity being used for intravenous infusion or any area where circulation is compromised or has the potential to be compromised.

WARNING: The blood pressure cuff should not be applied to the same extremity as the one to which an SpO2 sensor is attached, since cuff inflation will disrupt SpO2 monitoring and lead to nuisance alarms.

WARNING: During use on patients, ensure that heavy objects are not placed on the hose. Avoid crimping or undue bending, twisting, or entanglement of the hose.

Note: A patient’s vital signs may vary dramatically during

administration of agents affecting the cardiovascular system, such as those used to raise or lower blood pressure or raise or lower heart rate.

SETUP CONNECTIONS

Use only a Nellcor SHBP-10 hose and SCBP-Series cuff with the NPB-4000/C or a hose and cuff recommended by Nellcor’s Technical Services.

Measure the patient’s limb and select the proper size cuff. As a general rule, cuff width should span approximately two-thirds of the distance between the patient’s elbow and shoulder. Refer to Table 19.

NIBP Monitoring

Table 19: Cuff Sizes

Model Number Limb Circumference Range

SCBR-6R; infant 6 cm (2.4 in.) 10 - 19 cm (4.0 - 7.5 in.)

SCBP-9R; child/adult

18 - 26 cm (7.1 - 10.2 in.)

9 cm (3.5 in.)

SCBP-12R; adult 12 cm (4.75

25 - 35 cm (9.9 - 13.8 in.)

in.)

SCBP-15R; large arm 15 cm

33 - 47 cm (13.0 - 18.5 in.)

(6.0 in.)

SCBP-18R; thigh 18 cm (7.1 in.) 46 - 66 cm (18.1 - 26.0 in.)

Follow cuff directions for use for applying the cuff to the arm or thigh. Connect the hose to the front panel connector of the monitor.

NIBP Monitoring

NIBP MEASUREMENT MODES

Blood pressure measurements can be made in three modes:

Single

One measurement of each of the three blood pressures (Systolic/Mean Arterial Pressure/Diastolic) is made and displayed in the numeric frame.

Automatic

Measurements are made at preset intervals.

STAT

As many measurements as possible are made within a 5-minute period.

Adjustable Initial Inflation Pressure

The user may select an initial cuff inflation pressure. This is particularly important with children, since an initial cuff inflation pressure of 180 mmHg may be uncomfortable, and is typically higher than it needs to be. The initial inflation pressure can be set from 100 to 280 mmHg, in intervals of 20 mmHg.

The numeric display in the lower right corner of the NIBP frame indicates the setting of the initial inflation pressure which will be used during the next measurement or the instantaneous pressure in the cuff whenever a measurement is underway.

The initial inflation pressure is determined in one of two ways:

1) Upon power up, and immediately after making a change in the

adjustable initial inflation pressure via the NIBP menu, the initial inflation pressure is determined by the setting indicated in the NIBP menu. 2) Immediately after an NIBP reading has been successfully completed, the initial inflation value is changed to the just-completed Systolic pressure plus 50 mmHg (rounded off to the nearest 5 mmHg).

To Initiate a Single Blood Pressure Measurement

Press (momentarily) the front panel NIBP Start/Stop switch. A single blood pressure measurement will be made.

In addition to displaying the three pressure measurements, the monitor numeric frame displays a clock icon and a numeric value, which indicate the elapsed time in minutes since last taking a measurement.

The measurements remain in the numeric frame for 60 minutes. At the end of the 60-minute interval, the measured value and the icon are removed from the display.

As soon as an NIBP measurement begins, any existing NIBP values in the numeric frame are removed, and the current, variable value of the cuff pressure is shown. Systolic, diastolic, and MAP values are presented when the measurement is completed.

Absence of valid measurement values because of a low-priority alarm condition will result in “dashes” in the display.

To Make NIBP Measurements Automatically

Select the desired automatic measurement interval from the menu, accessed via the NIBP numeric frame. Upon selection, automatic mode is activated and the initial measurement will be made “X” minutes later (where “X” is the chosen interval). If a measurement is desired immediately, press the front panel NIBP Start/Stop switch.

The NIBP numeric frame will display the AUTO mode icon and the number of minutes selected for the interval between measurements. This icon and its numeric value are in addition to the clock icon and elapsed time since last measurement.

NIBP Monitoring

To initiate STAT mode of NIBP operation

Press the front panel NIBP STAT switch and hold it for at least 2 seconds.

While STAT mode is active (5 minutes), the STAT icon appears in the numeric frame; the clock icon and minutes displays are removed.

Upon completion of STAT mode, the last measurement made in that mode is displayed, and both the clock icon and elapsed time numeric return to the display.

At 60 minutes after completion of the STAT measurements, the displayed NIBP measurement and the clock icon are removed.

NIBP Monitoring

To Stop Blood Pressure Measurements

If a measurement is in process, press the front panel NIBP Start/Stop switch at any time that you wish to stop the current

measurement and deflate the cuff. If an automatic measurement is underway, the interval time will be reset.

Low Priority NIBP Alarms

Several conditions may occur to disrupt an NIBP measurement. Table 20 summarizes the conditions and the recommended corrective action.

Table 20: Low Priority NIBP Alarms

Low Priority Alarm

Recommended Action

Message

NIBP - No Cuff Check to see that the cuff is present. Check the

cuff and hose connections for leaks. Take a measurement again.

NIBP - Blocked Hose Check to see that the hose is not obstructed or

pinched. Take a measurement again.

NIBP - Artifact Monitor detected artifact, usually caused by

patient movement. In the presence of moderate artifact, the monitor may be able to complete the measurement and display blood pressure values. However, in this case the clinician may wish to repeat the measurement if the values seem questionable. More severe artifact will prevent the measurement from being completed, and dashes will be displayed in the NIBP numeric frame. In this case, check the patient, cuff application and cuff orientation. Take a measurement again.

NIBP - Time-Out Measurement could not be completed within

the normal amount of time. Check the patient. Check the cuff application and orientation. Take a measurement again.

NIBP Monitoring

CONTROLLING NIBP FUNCTIONS VIA NUMERIC FRAME

/min

0.5

SpO

mmHg

( )

NIBP Ð Blocked Hose

mmHg

Adult 2/14/95 16:34:36

140/90

1. Timer Icon-Minutes Since Last Measurement

2. Systolic / Diastolic Values

3. Initial cuff inflation pressure (Note)

4. Auto Mode Icon-Interval In Minutes

5. Mean Arterial Pressure Value

6. NIBP Icon

7. Units of Measure

(106)

180

Figure 17: NIBP Screen

140/90

(106)

( )

/min

37.8

180

Note: If measurement is underway, this field displays the

instantaneous pressure in the cuff.

NIBP Monitoring

Table 21: NIBP Menu

Level 1 Menu Level 2 Menus or Response

Title: NIBP MENU

Automatic Mode Interval Off, 1 min, 3 min, 5 min, 10 min,

15 min, 30 min, 60 min, 90 min

Initial Inflation Pressure 100, 123, 140, 160, 180, 200, 220, 240,

260, 280

S/D/M limits Variable (refer to Table 13, page 50)

Alarm silence icon On/Off

Return

Exits Level 1 menu immediately, returns to Monitoring Screen

SpO2 MONITORING

General

Safety Information

SpO Setup Connections

Functions via Numeric Frame

Controlling SpO Controlling SpO Pulse Search Condition

GENERAL

Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and 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 systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO

The NPB-4000/C utilizes C-LOCK® ECG synchronization to enhance signal processing during patient movement or poor perfusion. C-LOCK synchronization utilizes the QRS signal as a reference point for identifying the oximetry pulse, thus enhancing “good” pulses and reducing the effect of random artifacts associated with motion and low perfusion.

Waveform via Graphic Frame

The measured SpO

value from an oximeter may differ from the

saturation value that is calculated from a blood gas partial pressure of oxygen (PO

). This usually occurs because the

calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO

and

saturation: pH, temperature, partial pressure of carbon dioxide (PCO

), 2,3-DPG, and fetal hemoglobin.

SpO2 Monitoring

This monitor measures functional saturation — oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast, hemoximeters such as the IL482 report fractional saturation — oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobin. To compare functional saturation measurements to those from an instrument that measures fractional saturation, fractional measurements must be converted as follows:

functional saturation =

100 – (% carboxyhemoglobin + % methemoglobin)

SpO2 SAFETY INFORMATION

fractional saturation

x 100

WARNINGS: Use only Nellcor SpO

2 sensors for SpO2

measurements. Other SpO2 sensors may cause improper NPB-4000/C performance.

WARNING: Tissue damage can be caused by incorrect application or use of an SpO2 sensor, for example by wrapping the sensor too tightly or by applying supplemental tape. Inspect the sensor site as directed in the sensor directions for use to ensure skin integrity and correct positioning and adhesion of the sensor.

WARNING: Do not use damaged SpO2 sensors. Do not use an SpO2 sensor with exposed optical components. Do not immerse sensor completely in water, solvents, or cleaning solutions because the sensor and connectors are not waterproof. Do not sterilize SpO2 sensors by irradiation, steam, or ethylene oxide. Refer to the cleaning instructions in the directions for use for reusable SpO2 sensors.

WARNING: Inaccurate readings could result if a sensor is used incorrectly. Before using a sensor, carefully read and understand the sensor directions for use.

SpO2 Monitoring

WARNING: Inaccurate measurements may be caused by:

• incorrect sensor application or use

• significant levels of dysfunctional hemoglobin (such as

carboxyhemoglobin or methemoglobin)

• 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 heating lamps, or direct sunlight

• excessive patient movement

• high-frequency electrosurgical interference and

defibrillators

• venous pulsations

• placement of a sensor on an extremity with a blood

pressure cuff, arterial catheter, or intravascular line

• the patient has hypotension, severe vasoconstriction,

severe anemia, or hypothermia

• there is arterial occlusion proximal to the sensor

• the patient is in cardiac arrest or is in shock

WARNING: Loss of pulse signal can occur in any of the following situations:

• the sensor is too tight

• there is excessive illumination from light sources such as

a surgical lamp, a bilirubin lamp, or sunlight

• a blood pressure cuff is inflated on the same extremity as

the one to which an SpO2 sensor is attached

SETUP CONNECTION

Use only Nellcor sensor extension cables and SpO the NPB-4000/C.

When selecting a sensor, consider the patient’s weight and activity, adequacy of perfusion, availability of sensor sites, need for sterility, and anticipated duration of monitoring. For more information, refer to Table 22, page 76, or your local Nellcor representative.

sensors with

SpO2 Monitoring

Table 22: SpO2 Sensors

Oxygen Transducer Model

Oxisensor II

(sterile, single use)

Oxicliq

(sterile, single, use)

Dura-y

(nonsterile, reusable)

Durasensor

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

A P N* I

D-YS* D-YSE

DS-100A >40 kg

Patient Weight

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

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

>1 kg >30 kg

(nonsterile, reusable)

Nellcor reflectance sensor

RS-10 >40 kg

(Nonsterile, limited reuse)

*Although these Nellcor sensors are specified for use on very small patients, as well as pediatric and adult patients, the NPB4000/C monitor should NOT be used to monitor neonates.

Observe all warnings and cautions in the directions for use supplied with these sensors. Carefully apply the sensor to the patient, as described in the sensor directions for use. The sensor may be connected directly to the NPB-4000/C front panel connector, identified with the SpO

icon. Typically, however, it

is more convenient to connect the sensor to the monitor by using a Nellcor SpO

extension cable. Periodically check to see that

the sensor remains properly positioned on the patient and that skin integrity is acceptable. Refer to sensor directions for use.

SpO2 Monitoring

High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of an SpO

sensor. To prevent

interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material. Failure to take this action in high ambient light conditions may result in inaccurate measurements.

If patient movement presents a problem, verify that the sensor is properly and securely applied; move the sensor to a less active site; use an adhesive sensor that tolerates some patient motion; or use a new sensor with fresh adhesive backing.

For reusable sensors, follow the sensor directions for use for cleaning and reuse. For-single-patient use sensors, use a new sensor for each patient. Do not sterilize any Nellcor sensor by irradiation, steam, or ethylene oxide.

SpO2 Monitoring

CONTROLLING SpO2 FUNCTIONS VIA NUMERIC FRAME

/min

0.5

SpO2

( )

NIBP - Blocked Hose

Adult 2/14/95 16:34:36

Figure 18: SpO2 Screen

1. Units of Measure

2. Pulse Amplitude Indicator

3. Audible Alarm Bell Icon Icon

4. SpO

SpO2

mmHg

140/90

( )

/min

(106)

180

37.8

SpO2 Monitoring

Table 23: SpO2 Menu

Level 1 Menu Level 2 Menus or Response

Title: SpO2 MENU

SpO2 Response Slow, Normal, Fast

C-Lock On, Off

SpO2 limits Variable (refer to Table 13, page 50)

SpO2 alarm silence icon On/Off (audible on)

Return

SpO2 Response Modes

Normal (Mode 1): Recommended for most clinical situations in conjunction with C-LOCK ECG synchronization to reduce the effect of patient motion.

Fast (Mode 2): Useful for special applications such as sleep studies in which the user desires fast response. Most affected by patient motion.

Slow (Mode 3): Least affected by patient motion. Should be used only if Normal mode with C-LOCK does not perform acceptably. User must be aware that changes in SpO reported more slowly relative to other modes. Heart rate from SpO

is not displayed when slow response mode is enabled.

C-LOCK Operation

When C-LOCK is turned on in the SpO2 menu, C-LOCK automatically becomes operational any time a valid ECG signal is detected by the monitor. It is not necessary to turn C-LOCK off if an ECG signal is not available; the monitor handles this function automatically.

Exits Level 1 menu immediately, returns to Monitoring Screen

are

If the ECG signal is noisy, or of poor quality, SpO may be improved by turning C-LOCK off.

performance

SpO2 Monitoring

Pulse Amplitude Indicator

The pulse amplitude indicator is a segmented display within the SpO

numeric frame that shows the relative strength of the

detected pulse. With each pulse, contiguous segments are briefly filled; the stronger the pulse, the greater the number of filled segments.

Pulse Search Condition

The NPB-4000/C displays a status message “SpO2 Pulse Search” to indicate that it is attempting to locate the patient’s pulse. An SpO order for the SpO

sensor must be connected to the NPB-4000/C in

pulse search condition to occur.

CONTROLLING SpO

0.5

SpO

( )

NIBP Ð Blocked Hose

SpO

WAVEFORM VIA GRAPHIC FRAME

/min

SpO2

37.8

180

mmHg

140/90

(106)

( )

/min

Adult 2/14/95 16:34:36

Figure 19: SpO2 Waveform Screen

1. SpO

2. SpO

Waveform

Icon

SpO2 Monitoring

Table 24: SpO2 Waveform

Level 1 Menu Level 2 Menus or Response

Title: SpO2 WAVEFORM

Sweep speed 12.5 mm/s, 25 mm/s, 50 mm/s

ECG Waveform

>SpO

2 Waveform

Respiration Waveform Tabular Trend HR Graphical Trend SpO

Graphical Trend

NIBP Graphical Trend RR Graphical Trend Temperature Graphical Trend

Return

No level 2 menu for these items; selection of a new graphic type immediately causes the title and the first menu items to update, reflecting the new choice.

Exits Level 1 menu immediately, returns to Monitoring Screen

[THIS PAGE INTENTIONALLY LEFT BLANK]

RESPIRATION MONITORING

General Respiration Safety Information Setup Connections Controlling Respiration Functions via Numeric Frame Controlling Respiration Waveform via Graphic Frame

GENERAL

The patient’s respiration is detected by using two of the three leads of the ECG electrodes and cable. A low-level excitation signal is applied to these leads, and the variation of the thoracic impedance caused by the breathing effort is sensed and processed for measurement and screen presentation.

Real-time respiratory information is presented as a waveform in a graphic frame; respiration rate is presented in a numeric frame and in tabular trend data.

RESPIRATION SAFETY INFORMATION

WARNINGS: The NPB-4000/C is a respiration rate monitor only. The NPB-4000/C should NOT be used for the detection of apnea. Do not use the NPB-4000/C to monitor neonates.

WARNING: Keep patients under close surveillance when monitoring respiration. Respiration signals are relatively more sensitive to interference from radiated electromagnetic signals. Thus, it is possible, although unlikely, that radiated electromagnetic signals from sources external to the patient and NPB-4000/C can cause inaccurate respiration readings. Do not rely entirely on the NPB-4000/C respiration readings for patient assessment.

Respiration Monitoring

SETUP CONNECTIONS

The respiration signal is acquired using the ECG electrodes, leads and cable. Refer to the ECG Monitoring section, page 55, for information regarding patient connection.

Respiration monitoring performance may be improved by an alternate electrode placement, relative to standard ECG electrode placement.

• Left arm (LA) electrode placement is the left

midaxillary line just below the nipple level.

• Right arm (RA) electrode placement is the right

midaxillary line just below the nipple level.

• Left leg (LL) electrode placement is unchanged

relative to standard ECG lead placement.

The user should be aware that this alternate electrode placement may change the shape and amplitude of the ECG waveform.

CONTROLLING RESPIRATION FUNCTIONS VIA NUMERIC FRAME

/min

0.5

SpO2

mV cm

SpO2

( )

NIBP Ð Blocked Hose

/min

( )

mmHg

140/90

( )

/min

Adult 2/14/95 16:34:36

(106)

180

37.8

Figure 20: Respiration Rate Screen

1. Units of Measure 3. Audible Alarm Bell Icon

2. Measured Value 4. Respiration Icon

Respiration Monitoring

Table 25: Respiration Rate Menu

Level 1 Menu Level 2 Menus or Response

Title: RESPIRATION RATE MENU Respiration On, Off

Respiration rate limits Variable (refer to Table 13, page 50) Respiration rate alarm On/Off (audible on)

Return

Exits Level 1 menu immediately, returns to Monitoring Screen

Loss of Respiration Signal Alarm

If the NPB-4000/C patient monitor does not detect a respiration signal for 40 consecutive seconds, a loss of respiration signal alarm will be issued. Check the condition of the patient, then check the condition of the electrodes and lead/cable connections. The alternate electrode placement described in Setup Connections, page 84, may improve respiration-monitoring performance. If poor signal quality persists, the user may choose to turn Off respiration monitoring, as described below.

CAUTION: When the respiration rate limits audible alarm has been permanently silenced (the slashed-bell icon is present), the loss of respiration signal audible alarm will also be permanently silenced.

Respiration Monitoring On/Off

When respiration monitoring is turned Off in the Respiration Rate menu, the respiration rate value and respiration waveform will be blanked, and no respiration monitoring alarms will function.

Respiration Monitoring

CONTROLLING RESPIRATION WAVEFORM VIA GRAPHIC FRAME

/min

0.5

SpO

( )

NIBP Ð Blocked Hose

( )

Figure 21: Respiration Waveform Screen

1. Respiration Waveform

2. Respiration Icon

SpO

37.8

180

mmHg

140/90

(106)

( )

/min

Adult 2/14/95 16:34:36

Respiration Monitoring

Table 26: Respiration Waveform Menu

Level 1 Menu Level 2 Menus or Response

Title: RESPIRATION WAVEFORM MENU

Sweep Speed 6.25 mm/s, 12.5 mm/s, 25 mm/s

other graphic choices:

ECG Waveform

Waveform

SpO >Respiration Waveform Tabular Trend HR Graphical Trend SpO

Graphical Trend

NIPB Graphical Trend RR Graphical Trend Temperature Graphical Trend

Return

No level 2 menu for these items; selection of a new graphic type immediately causes the title and first menu items to update, reflecting the new choice.

Exits Level 1 menu immediately, returns to Monitoring Screen

[THIS PAGE INTENTIONALLY LEFT BLANK]

TEMPERATURE MONITORING

General Setup Connections Controlling Temperature Functions via Numeric Frame

GENERAL

Measurement of patient temperature is accomplished by processing the signal from a probe containing a resistance element whose impedance is temperature dependent. These devices are called thermistors. The signal from the probe is conditioned by the monitor input circuitry, processed, and the measured values are shown in the numeric frame.

Setup Connections

The NPB-4000/C patient monitor is designed to accept signals from YSI Series 400-compatible thermistor probes. Interchangeable probes in this series may be used for esophageal, rectal, skin or surface, or airway temperature measurement. Follow the directions for use accompanying the temperature probe. If YSI-compatible probes are not readily available, contact Nellcor’s Technical Services Department or your local Nellcor representative. To avoid nuisance limit alarms, the probe should be affixed to the patient before connecting to the NPB-4000 and NPB-4000C front panel connector.

Temperature Monitoring

CONTROLLING TEMPERATURE FUNCTIONS VIA NUMERIC FRAME

/min

0.5

SpO

( )

NIBP Ð Blocked Hose

Figure 22: Temperature Screen

1. Measured Value

2. Units of Measure

3. Alarm Bell

4. Temperature Icon

SpO2

180

37.8

mmHg

140/90

(106)

( )

/min

Adult 2/14/95 16:34:36

37.8

Table 27: Temperature Menu

Level 1 Menu Level 2 Menus or Response

Title: TEMPERATURE MENU Units º C, º F

Temperature limits Variable (refer to Table 13, page 50) Temperature alarm On/Off

Return

Exits Level 1 menu immediately, returns to Monitoring Screen

TRENDS

General Displaying Trend Data Selecting a 2-Hour Portion of the Graphical Trend for Display Printing Trend Information (Printer Option Installed) Changing the Vertical Scale Range Selecting Different Trend Records Graphical Trend Operation Summary Tabular Trend Data Transferring Trend via RS-232

GENERAL

Trend Data Storage

Trend Data in graphical or tabular format may be displayed on the screen, and printed if a printer is installed.

Trend data for all parameters except NIBP is the average of a 20-second sample of the data. For NIBP, the trend data is the measured values. Twelve (12) hours of trend data is stored in a nonvolatile memory, and remain in storage when the monitor is in Standby.

A new record of trend data is started each time the monitor is turned On. A trend data record is defined as the data from one power On event to the Standby power event. A date/time annotation is included at the start of each new record (up to ten are possible) so the record can be correlated with the patient.

Once trend memory has stored 12 hours of data, the oldest trend data will be overwritten by new data.

Trend Displays

Trend data is displayed in graphical or tabular format. Trend information in graphical format for a selected parameter is shown as a line connecting each of the points representing the stored 20-second average.

Trends

NIBP values are shown as vertical lines. The vertical displacement of the top of the line represents the systolic pressure, the bottom represents the diastolic pressure, and a short blank space in the line represents the mean arterial pressure values. Two hours of graphic trend data are displayed in one graphic frame.

There is one tabular trend format, containing trend data for all monitored parameters. The tabular trend data values are selected each time an NIBP measurement is made or once every 15 minutes, whichever comes first. In the event of an alarm condition, each 20-second average is shown until the alarm is corrected. In addition, during the alarm state, the limit(s) being exceeded are displayed in reverse video. The selected trend segment is obtained by user interaction with the menu.

DISPLAYING TREND DATA

1. Rotate the knob to highlight the graphic frame in which the desired trend is to appear.

2. Press the knob.

3. The Level 1 menu for this frame appears in graphics frames 2 and 3.

4. Rotate the knob to highlight the trend description item in the Level 1 menu.

5. Press the knob. Control is returned to the Level 1 menu.

6. Rotate the knob until the Return message is highlighted.

7. Press the knob.

The display now contains a graphical trend (if selected) or a tabular trend (if selected) in the previously highlighted graphic frame location.

Trend Screen Example

In Figure 23, page 93, tabular trend data for all monitored parameters is displayed in the middle graphics frame; graphical trend data for the SpO graphics frame.

The newest data appears at the right of graphical trends, and at the top of tabular trends.

parameter is displayed in the bottom

Trends

Additional control of trend operations is obtained by interaction with the trend display.

/min

0.5

TREND - 2/14 8/8

Time NIBP HR SpO2 RR T 16:34:36 140/90(97) 85 97 14 37.8

210/145(169)

16:24:36 84 98 10 38.0

210/150/165

16:14:36 96 14 38.1

210/150/165

16:14:36 96 14 38.1 16:05:36 155/97(108) 95 95 18 38.9 16:05:36 156/100(112) 100 94 18 39.3

SpO2 - 2 HOURS 8/8

110 110

Press Knob to Exit Scroll

100

80 60

16:34 2/14

Adult 2/14/95 16:34:36

TREND - 2/14 8/8

Time NIBP HR SpO2 RR T 16:34:36 140/90(97) 85 97 14 37.8 16:24:36 84 98 10 38.0

16:14:36 96 14 38.1 16:14:36 96 14 38.1

16:05:36 155/97(108) 95 95 18 38.9 16:05:36 156/100(112) 100 94 18 39.3

SpO2 - 2 HOURS 8/8

210/145(169) 210/150/165 210/150/165

110 110

Press Knob to Exit Scroll

SpO2

mmHg

140/90

(106)

/min

16:34

180

37.8

100 80

2/14

Figure 23: Graphical and Tabular Trend Screens

1. Record Number/Total Records 6. Time

2. Units of Measure 7. Two Hours of Trend Data

3. Vertical Axis Range Scale 8. Title

4. Date 9. Five Tabular Rows

5. Time Bar 10. Title

Trends

Figure 23 shows the eighth trend record out of eight stored, as indicated by the 8/8 in the upper right corner of the trend screen (1/8 would be the current one). The time bar at the right edge of the trend graph indicates the most recent trend value in the display and corresponds to the time value displayed below it.

Two hours of graphical trend and five rows of tabular data are presented in their frames on the screen at any one time. The capability for viewing more trend data is obtained by using the scroll function.

SELECTING A 2-HOUR PORTION OF THE GRAPHICAL TREND FOR DISPLAY:

1. Rotate the knob until the trend graphics frame is highlighted. The highlighting is shown in Figure 23, page 93.

2. Press the knob.

The Level 1 menu for the waveform trend appears in graphic frames 2 and 3. (The menu may temporarily obscure the trend graphics frame.)

The first item is Scroll/Print Trend.

The display is shown in Figure 24, page 96.

3. Rotate the knob to highlight the top menu item Scroll/Print

Trend.

4. Press the knob. The Level 1 menu is removed from the screen. The knob is now activated.

5. Rotate the knob to scroll through the record. Counterclockwise rotation moves the 2-hour window forward in time; clockwise rotation backs up the window. Each rotational “click” of the knob moves the window in 15-minute increments.

6. After viewing the trend, press the knob again to exit the scrolling function and return to the Level 1 menu. If no other changes are desired, select Return to Return to the normal monitoring screen.

Nellcor NPB-4000, N-4000C User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

CONTENTS

FIGURES

TABLES

SAFETY INFORMATION

INTRODUCTION

INTENDED USE

ABOUT THIS MANUAL

CONTROLS, INDICATORS, AND SYMBOLS

FRONT PANEL

REAR PANEL

QUICK GUIDE TO OPERATION

FEATURES

PHYSICAL/MECHANICAL

ELECTRICAL

DISPLAY

AUXILIARY OUTPUTS

OPTIONS AND ACCESSORIES

SETUP and USE

UNPACKING AND INSPECTION

POWER CABLE CONNECTIONS

MEASUREMENT CABLE CONNECTIONS

POWER ON AND SELF-TEST

SET DATE AND TIME

DISPLAY and OPERATION

THE DISPLAY CONFIGURATION

CONTROLLING MONITOR OPERATION AND DISPLAY ELEMENTS

ALARMS and LIMITS

GENERAL

ALARM PRIORITY

LOSS-OF-MONITORING ALARM

VISUAL ALARM INDICATORS

AUDIBLE ALARM INDICATORS

SETTING AND CHANGING ALARM LIMITS

USING THE ALARM/LIMITS SCREEN

AUTO-SET ALARM LIMITS

USING THE NUMERIC FRAME

ALARM LIMITS AND FACTORY-SET DEFAULT VALUES

ALARM SILENCE SWITCH

ALARM SUSPEND

ECG MONITORING

GENERAL

ECG SAFETY INFORMATION

SETUP CONNECTIONS

CONTROLLING ECG FUNCTIONS VIA NUMERIC FRAME

CONTROLLING ECG WAVEFORM VIA GRAPHIC FRAME

NIBP MONITORING

GENERAL

NIBP SAFETY INFORMATION

SETUP CONNECTIONS

NIBP MEASUREMENT MODES

CONTROLLING NIBP FUNCTIONS VIA NUMERIC FRAME

SpO2 MONITORING

General

SpO2 SAFETY INFORMATION

SETUP CONNECTION

CONTROLLING SpO2 FUNCTIONS VIA NUMERIC FRAME

RESPIRATION MONITORING

GENERAL

RESPIRATION SAFETY INFORMATION

SETUP CONNECTIONS

CONTROLLING RESPIRATION FUNCTIONS VIA NUMERIC FRAME

TEMPERATURE MONITORING

GENERAL

TRENDS

GENERAL

DISPLAYING TREND DATA