Nellcor Patient Monitor N-4000 and 4000 C Operators Manual

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.

CONTENTS 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 SpO2 Monitoring ... 73 General ... 73 SpO2 Safety Information ... 74 Setup Connection... 75 Controlling SpO2 Functions Via Numeric Frame ... 78 Controlling SpO2 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 iv

Contents

General ...109 Electrical ...110 Environmental ...111 Measuring Parameters ...111 Trends...115 RS-232 Interface...117 Overview ...117 Cable Connection ...117 Nurse-Call ...118 Exporting Trend Data...118 Defib Sync Output ...122 Defib Sync Output...122 NPB-4000/C Defib Sync ...122 Optional Accessories ...123 Printer ...123 GCX Mount ...123 Accessory Bag ...123 Defib Sync Cable ...123 DC Input Cable ...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; Level 1 and Level 2 Menus...37 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 (if using MCL1, select Lead II) ...59 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 v

Contents

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

TABLES 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

vi

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.

1

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.

2

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.

3

[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.

5

[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 1

2

3

4

Figure 1: Front Panel, NPB-4000/C 1. 2. 3. 4.

Display: (the major area of the panel) Switch Panel: (to the right of the display) Patient Connectors: (along the bottom of the panel) Control Knob: (the lower right corner of the panel)

7

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

Connector Compatibility

Icon

ECG

Compatible with Nellcor CE-10 ECG Cables

SpO2

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

SpO2 %

T

Switch Panel

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

Switched/LED Descriptor On/Standby Switch

8

Icon

Operation Toggles NPB-4000/C between ON and STANDBY modes

Controls, Indicators, and Symbols

Table 2: Switch Panel Symbols

Switched/LED Descriptor

Icon

Operation

AC source LED Indicator

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

DC source LED Indicator

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

NIBP Start/Stop Switch

Toggles between starting and stopping NIBP measurement

NIBP STAT icon

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

Alarm Silence Switch

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

Heart Rate Tone Volume Switch

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).

9

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 /min

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

SpO2 %

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

SpO2 %

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

SpO2 alarm. 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.

10

Controls, Indicators, and Symbols

Table 3: Display Symbols

NIBP mmHg

140/90 (106) 30

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

180 17

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 Rate

/min

Respiration icon and units of measure Respiration alarm. Displayed when a respiration rate alarm limit has been violated. Audible Alarm Off. Displayed when audible alarm is silenced

Temperature

T

Temperature icon

C

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. 11

Controls, Indicators, and Symbols

Table 3: Display Symbols

Display - Graphic Frame Symbols ECG Waveform ECG icon Size bar, 1 cm high 0.5 mV cm

Size scale

II

Lead pair

SpO2 Waveform SpO2 %

SpO2 icon

Respiration Waveform

( )

12

Respiration icon

Controls, Indicators, and Symbols

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.

1 2

3 4 5

Figure 2: Rear Panel, NPB-4000/C Table 4: Rear Panel Connectors

Figure 2 Callout 1

Description DC Input

Connector Type

Icon

2-line; + and ground 10 - 16V 5A

2

Equipotential

3

Defib Sync

4

AC Input

5

RS-232 I/O

Equipotential ground 2.5 mm subminature phone jack 3-line connector, IEC 320 receptacle DB-9 (male)

100 - 240V ~ 50 - 60 Hz 1A RS-232

13

[THIS PAGE INTENTIONALLY LEFT BLANK]