Life Scope P Model BSM-4100 J, K Operator's Manual

CONTENTS

Contents GENERAL HANDLING PRECAUTIONS ... i WARRANTY POLICY ... ii EMC RELATED CAUTION ... iii Conventions Used in this Manual and Instrument ... v Warnings, Cautions and Notes ... v Explanations of the Symbols in this Manual and Instrument ... vi On panel ... vi On screen ... vii Others ... vii

Section 1

General ... 1C.1 Introduction ... 1.2 Features ... 1.3 Composition ... 1.6 Network Composition ... 1.7 Panel Description ... 1.8 Front Panel ... 1.8 Socket Panel ... 1.10 Left Side Panel ... 1.12 Right Side Panel ... 1.12 Basic Operating Concepts ... 1.13 Screen Displays ... 1.13 Using Touch Screen Keys ... 1.19 Keys on the Front Panel ... 1.20 Using Function Dials ... 1.21 Using MENU Window ... 1.21 General Safety Information ... 1.22 General ... 1.22 Installation ... 1.24 Using ZB-800P/ZS-900P Transmitter ... 1.24 Network ... 1.25 Battery ... 1.26 12 Lead ECG Interpretation (BSM-4103/4113 monitors only) ... 1.26 ECG Monitoring ... 1.27 Respiration Monitoring ... 1.28 SpO2 Monitoring ... 1.29 NIBP Monitoring ... 1.31 IBP Monitoring ... 1.32 Temperature Monitoring ... 1.33 CO Monitoring ... 1.33 CO2 Monitoring ... 1.34 FiO2 Monitoring ... 1.37 Maintenance ... 1.37

Operator's Manual BSM-4100

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CONTENTS

Section 2

Preparations ... 2C.1 Preparation Flowchart ... 2.1 Installation Conditions ... 2.2 Loading the Recording Paper ... 2.4 Attaching the Touch Pen ... 2.6 Connecting the Optional Transmitter ... 2.7 Using ZB-800P Transmitter ... 2.7 Using ZS-900P Transmitter ... 2.8 Connecting an External Instrument to the Monitor ... 2.9 Connecting the Monitor to a Network ... 2.10 Installing the Optional Network Card or Network Printer Card ... 2.11 Power ... 2.13 AC or Battery Power Source Selection ... 2.13 Connecting the Power Cord and Grounding the Monitor ... 2.13 Connecting the Power Cord ... 2.13 Grounding the Monitor ... 2.14 Turning the Power On ... 2.14 Check Before Turning On the Power ... 2.14 Turning the Power On ... 2.15 Standby Mode ... 2.15 Check After Turning On the Power and During Monitoring ... 2.16 Turning the Power Off ... 2.16 Check After/Before Turning the Power Off ... 2.17 Power and Battery Status Indications ... 2.17 Battery Handling and Operation ... 2.18 Safety Information ... 2.18 Battery Handling Procedures ... 2.19 When Using a Battery for the First Time or After Storage ... 2.19 When Not Using the Monitor or Battery ... 2.19 When the BATTERY WEAK Message Appears ... 2.19 Inserting or Replacing the Battery ... 2.20 Charging the Battery ... 2.20

Section 3

Changing System Setup Settings ... 3C.1 Displaying the SYSTEM SETUP Screen ... 3.2 Changing Settings ... 3.3 Closing the SYSTEM SETUP Screen and Displaying the Monitoring Screen ... 3.3 List and Explanation of the SYSTEM SETUP Settings ... 3.4 List of All Settings ... 3.4 Site Setting (SITE) ... 3.6 Display Settings (DISPLAY SETUP) ... 3.6 Bed ID Setting (BED ID SETUP) ... 3.8 Parameter and Other Settings (PARAMETER SETUP) ... 3.8 NIBP Settings (NIBP SETUP) ... 3.10 Alarm Settings (ALARM SETUP) ... 3.11 Unit Settings (UNITS SETUP) ... 3.15 Color Settings (COLOR SETUP) ... 3.16 Recording Settings (RECORD SETUP) ... 3.18

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CONTENTS Other Settings (OTHER SETUP) ... 3.19 Alarm Master Settings (ALARM MASTER) ... 3.20 Arrhythmia Recall Master Settings (ARRHYTHMIA RECALL MASTER) ... 3.21 Network Settings (NETWORK SETUP) ... 3.22 Network Printer Settings (PRINTER SETUP) ... 3.23 External Interface Information (EXT I/F SETUP) ... 3.25 Initializing the System ... 3.26

Section 4

Necessary Settings Before Monitoring ... 4C.1 Changing Date and Time ... 4.1 Changing Sound Settings ... 4.3 Changing the Screen Brightness ... 4.5 Assigning a Function to the Function Keys ... 4.6 Entering Patient Information ... 4.8 Displaying the PATIENT INFO Window ... 4.8 Entering the Patient Information ... 4.9 Entering the Patient Name ... 4.9 Entering the Date of Birth and Age ... 4.11 Entering the Height and Weight ... 4.12 Entering the Sex ... 4.12 Entering the Patient ID ... 4.12 Deleting Data ... 4.13

Section 5

Monitoring Screen ... 5C.1 Safety Precautions for Monitoring ... 5.2 Using an Electrosurgery Unit ... 5.2 Using a Defibrillator ... 5.2 Overview ... 5.3 Monitoring Screen ... 5.3 Review Windows ... 5.3 Sync Sound ... 5.4 Adjusting the Sync and Alarm Sound Volume ... 5.4 Changing Settings and Performing Other Tasks During Monitoring ... 5.4 Site Mode ... 5.4 Interbed Monitoring ... 5.4 Monitoring Screen ... 5.5 Settings for the Monitoring Screen ... 5.6 Waveform Sweep Mode and Speed ... 5.6 Trendgraph/OCRG Display on the Monitoring Screen On or Off ... 5.6 Numeric Data Display Over ECG when a Window is Opened ... 5.6 Blood Pressure Waveform Display Mode ... 5.6 Background and Parameter Colors ... 5.6 Waveform Sensitivity ... 5.6 Displaying Other Windows from the Monitoring Screen ... 5.7 Changing Settings for Monitoring Screen ... 5.8 Displaying OCRG ... 5.10 Freezing Waveforms ... 5.11

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CONTENTS Calibrating Waveforms ... 5.12 Using Sleep Mode ... 5.13 Turning Sleep Mode On ... 5.13 Turning Sleep Mode Off ... 5.14 Displaying the Large Numeric Window ... 5.15 Displaying Cascaded ECG Window ... 5.16 12 Lead ECG Window ... 5.17 Displaying the 12 LEAD Window ... 5.17 Recording ECG Waveforms on the 12 Lead Window ... 5.18 Performing 12 Lead ECG Interpretation ... 5.20

Section 6

Alarm Function ... 6C.1 Overview of Alarms ... 6.2 What is an Alarm ... 6.2 Alarm Level ... 6.2 Alarm Priority ... 6.3 Silencing and Suspending Alarms ... 6.3 Alarm Master ... 6.3 Automatic Recording ... 6.4 Alarm Setting ... 6.4 Adjusting Alarm Sound Volume ... 6.4 Standby Mode ... 6.4 Alarm History Window ... 6.5 Interbed Alarm ... 6.5 Alarm Types ... 6.6 Vital Signs Alarms ... 6.6 Arrhythmia Alarms ... 6.6 Parameter Alarms ... 6.7 ECG Related Alarms ... 6.7 SpO2 Related Alarms ... 6.7 NIBP Related Alarms ... 6.7 IBP Related Alarms ... 6.7 CO2 Related Alarms ... 6.7 Temperature Related Alarms ... 6.8 FiO2 Related Alarms ... 6.8 CO Related Alarms ... 6.8 Other Alarms ... 6.8 Messages... 6.8 ECG Related Messages ... 6.8 Respiration Related Messages ... 6.9 SpO2 Related Messages ... 6.9 NIBP Related Messages ... 6.9 IBP Related Message ... 6.9 CO Related Messages ... 6.10 CO2 Related Messages ... 6.10 FiO2 Related Messages ... 6.10 Other Messages ... 6.10 Alarm Indications ... 6.11

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CONTENTS Overview ... 6.11 Individual Alarm Indications ... 6.11 Vital Signs Alarms ... 6.12 Arrhythmia Alarms ... 6.13 Parameter Alarms ... 6.13 Other Alarms ... 6.15 Interbed Alarms ... 6.15 Alarm Control Marks ... 6.16 Alarm Suspend Mark ... 6.16 Alarm Recording Off Mark ... 6.16 Priority of Alarm Control Marks ... 6.16 Individual Vital Signs Alarm Off Marks ... 6.16 Adjusting the Alarm Sound Volume ... 6.16 Silencing/Suspending Alarms ... 6.17 Overview ... 6.17 Silencing an Alarm ... 6.17 Suspending All Alarms Before Occurrence ... 6.17 Silencing Alarms After Alarm Occurrence ... 6.18 Silencing Alarm ... 6.18 Canceling Alarm Silence ... 6.18 Suspending Alarms Before Alarm Occurrence ... 6.18 Suspending Alarms for Two Minutes ... 6.18 Suspending All Alarms and NIBP STAT and Auto Measurements Indefinitely 6.19 Suspending All Alarms Indefinitely ... 6.21 Turning Automatic Alarm Recording On/Off ... 6.23 Setting Alarm ... 6.25 Overview ... 6.25 Alarm Limits Ranges ... 6.25 Vital Signs Alarms ... 6.25 Arrhythmia Alarms ... 6.26 Setting Vital Signs Alarm Individually ... 6.27 Setting All Vital Signs Alarms to a Preset Pattern (Alarm Master) ... 6.28 Setting Arrhythmia Alarms Individually ... 6.29 Setting All Arrhythmia Alarms to a Preset Pattern (Alarm Master) ... 6.30

Section 7

Review Windows ... 7C.1 General ... 7.1 Trend Window ... 7.2 Overview ... 7.2 Displaying the TREND Window ... 7.3 Single Parameter Trendgraph ... 7.4 Selecting Parameter and Scale for the Single Parameter Trendgraph ... 7.4 Changing the Time Threshold for Apnea Trendgraph ... 7.5 Recording the Trendgraph ... 7.6 Printing the Trendgraph ... 7.7 List Window ... 7.8 Overview ... 7.8 Displaying the LIST Window ... 7.9

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CONTENTS Setting the List Interval for the Periodic Vital Signs List ... 7.10 Selecting Parameters to be Displayed on the LIST Window ... 7.11 Recording the List ... 7.12 Printing the List ... 7.12 Hemodynamics Window ... 7.13 Overview ... 7.13 Displaying the HEMO LIST Window ... 7.13 Explanation of the Hemodynamics List ... 7.14 Recording the Hemodynamics List ... 7.15 Printing the Hemodynamics List ... 7.15 Arrhythmia Recall Window ... 7.16 Arrhythmia List ... 7.16 Arrhythmia Waveform Annotation ... 7.17 Displaying the Arrhythmia Recall Window ... 7.17 Recording the Arrhythmia Recall Waveform ... 7.19 Printing the Arrhythmia Recall Waveform ... 7.19 Selecting the Arrhythmia Types to be Saved as a Recall File ... 7.20 Full Disclosure Window ... 7.22 Displaying the FULL DISC Window ... 7.23 Recording the Full Disclosure Waveform ... 7.24 Recording the Full Disclosure Data ... 7.24 Recording the Actual Size ECG Waveform ... 7.25 Printing the Full Disclosure Waveform ... 7.25 Printing the Compressed Full Disclosure Data ... 7.25 Printing the Actual Size ECG Waveform ... 7.26 ST Level Recall Window ... 7.28 Displaying the ST Window ... 7.28 Changing the Displaying Interval ... 7.29 Changing the ST Level Measurement Condition ... 7.30 Alarm History Window ... 7.31 Displaying the ALARM HISTORY Window ... 7.31 Recording the Alarm History Data ... 7.32

Section 8

Recording ... 8C.1 Overview of Recording ... 8.1 Recording Modes ... 8.2 Manual Waveform Recording/Printing ... 8.3 Recording/Printing on the 12 LEAD Window ... 8.3 Recording/Printing on the Review Windows ... 8.3 Recording on the CO Window ... 8.3 Recording OCRG ... 8.4 Periodic Recording ... 8.4 Alarm Recording ... 8.4 Recording Mode Annotations ... 8.5 Recording Priority ... 8.6 Recording Sensitivity ... 8.6 Recording Speed ... 8.6 Recording Related Message ... 8.6

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CONTENTS Recorded/Printed Data ... 8.7 Changing the Recording Speed ... 8.8 Changing the Recording Pattern ... 8.9 Manually Recording/Printing Waveforms ... 8.11 Recording Waveforms on the BSM-4101/4103 Monitors ... 8.11 Recording Waveforms on the BSM-4111/4113 Monitors ... 8.11 Manual Printing on the Network Printer ... 8.12 Setting Periodic Recording ... 8.13 Changing Settings for Automatic Periodic Recording ... 8.13 Printing on a Network Printer ... 8.15

Section 9

Drug Window... 9C.1 General ... 9.1 Drug Titration Initial Settings ... 9.2 Flow Rate Equations ... 9.3 Displaying the DRUG CALCULATE Window ... 9.4 Selecting the Drug ... 9.6 Assigning a Drug Name and Dosage Unit to DRUG A to D ... 9.7 Changing the Settings ... 9.9 Unit and Setting Range ... 9.10 Drug Amount, Dosage and Step ... 9.10 Solution Amount, Flow Rate and Weight ... 9.11

Section 10 Interbed Window... 10C.1 Registering Interbed Beds ... 10.2 Removing an Interbed Bed ... 10.3 Displaying the Interbed Bed Data ... 10.4 Displaying the Numeric Data of All Interbed Beds ... 10.6 Interbed Alarm ... 10.7 Setting Interbed Alarm On or Off ... 10.7

Section 11 ECG Monitoring ... 11C.1 General ... 11.1 Preparing for ECG Monitoring ... 11.3 Selecting a Lead ... 11.3 Preparation Flowchart ... 11.3 Number of Electrodes and Measuring Leads ... 11.4 Electrode Position ... 11.4 3 Electrode Leads ... 11.4 6 Electrode Leads ... 11.5 10 Electrode Leads ... 11.6 Selecting Electrodes and Lead ... 11.6 Types of Electrodes and Lead ... 11.7 Connecting Cables and Attaching Disposable Electrodes ... 11.8 Connecting the Electrode Cable to the Monitor ... 11.8 Attaching Disposable Electrodes to the Patient ... 11.9 Operator's Manual BSM-4100

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CONTENTS Monitoring ECG ... 11.10 ECG Information on the Monitoring Screen ... 11.10 Measuring ST Level ... 11.11 Monitoring Arrhythmia ... 11.11 Arrhythmia Analysis Classification Messages ... 11.12 Turning Arrhythmia Analysis On/Off ... 11.12 Learning the ECG Waveform for Arrhythmia Detection (VPC Learning) ... 11.13 Changing the Dominant QRS ... 11.15 Noise Detection and Display ... 11.16 Detached Electrode Detection and Display ... 11.17 Changing ECG Settings ... 11.18 Changing the Monitoring Lead ... 11.18 Changing a Lead ... 11.18 Assigning Va and Vb (Ca and Cb) Leads when Monitoring with 6 Electrodes 11.19 Auto Lead Change On or Off ... 11.20 Changing the ECG Sensitivity ... 11.20 Changing the Heart Rate or Pulse Rate and ST Alarm Limits ... 11.21 Changing the Arrhythmia Alarm Setting ... 11.23 Changing the Number of Electrodes ... 11.24 Changing the Sync Source ... 11.25 Selecting the Filter Mode ... 11.27 Selecting the Mode for Updating the Heart Rate ... 11.28 Turning Pacing Spike Detection On/Off ... 11.29 Displaying the Pacing Mark on the ECG ... 11.31 Use with an Electrosurgical Unit ... 11.33

Section 12 Respiration Monitoring ... 12C.1 General ... 12.1 Measurement Method ... 12.1 Impedance Method ... 12.1 Thermistor Method ... 12.2 Preparing for Respiration Monitoring in Impedance Method ... 12.3 Preparation Flowchart ... 12.3 Electrode Position and Waveform Examples ... 12.4 Connecting Cables and Attaching Disposable Electrodes ... 12.6 Preparing for Respiration Monitoring in Thermistor Method ... 12.7 Preparation Flowchart ... 12.7 Respiration Pickups ... 12.7 Connecting the Cable to the Monitor ... 12.8 Attaching the Respiration Pickup ... 12.8 When Using Respiration Pickup for Airway ... 12.8 When Using Respiration Pickup for Nose ... 12.8 Monitoring Respiration ... 12.9 Respiration Information on the Monitoring Screen ... 12.9 Changing Respiration Settings ... 12.10 Turning Respiration Monitoring On or Off in Impedance Method ... 12.10 Changing the Monitoring Lead in Impedance Method ... 12.12 Changing the Respiration Sensitivity ... 12.12

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CONTENTS Changing the Respiration Waveform Sweep Speed ... 12.13 Changing the Apnea Alarm Limit ... 12.14 Changing the Respiration Alarm Limits ... 12.15

Section 13 SpO2 Monitoring ... 13C.1 General ... 13.1 Preparing for SpO2 Monitoring ... 13.2 Preparation Flowchart ... 13.2 Selecting a Probe ... 13.3 Nihon Kohden Reusable Probes ... 13.3 Nihon Kohden Disposable Probes ... 13.4 Connecting Cables ... 13.5 Attaching the Probe to the Patient ... 13.5 Monitoring SpO2 ... 13.7 SpO2 Information on the Monitoring Screen ... 13.8 Detection and Display of Measurement Condition ... 13.9 CHECK PROBE Message (When the Finger Probe is Used) ... 13.9 PULSE SEARCH Message ... 13.9 M Message ... 13.9 Changing SpO2 Settings ... 13.10 Changing the Pulse Waveform Sensitivity ... 13.10 Changing the SpO2 Alarm Limits ... 13.11 Changing the Sync Source ... 13.12 Selecting Sync Sound Pitch ... 13.14 Changing the Response Mode ... 13.16

Section 14 NIBP Monitoring ... 14C.1 General ... 14.1 Preparing for NIBP Measurement ... 14.2 Preparation Flowchart ... 14.2 Selecting the Cuff ... 14.2 Types of Cuffs ... 14.4 Reusable Cuffs ... 14.4 Disposable Cuffs ... 14.6 Disinfecting Disposable Cuffs before Use ... 14.7 Connecting Cables and Attaching the Cuff to the Patient ... 14.7 Connecting Air Hose and Cuff to the Monitor ... 14.7 Attaching the Cuff to the Patient ... 14.9 Changing NIBP Settings ... 14.11 Selecting the Initial Cuff Inflation Pressure ... 14.11 Selecting the Measurement Mode and Interval ... 14.13 Measurement Modes ... 14.13 Selecting the Measurement Modes for the Mode Selection by the NIBP INTERVAL Key ... 14.16 Changing the NIBP Alarm Settings ... 14.17 Changing the PWTT Settings ... 14.18 Measuring and Monitoring NIBP ... 14.20 Operator's Manual BSM-4100

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CONTENTS Recommended Patient State ... 14.20 Starting and Stopping NIBP Measurement ... 14.21 Manual Mode ... 14.21 STAT Mode ... 14.21 Auto Mode ... 14.21 NIBP Information on the Monitoring Screen ... 14.22 Dimming and Hiding the NIBP Data ... 14.22

Section 15 IBP Monitoring ... 15C.1 General ... 15.1 Preparing for Blood Pressure Monitoring ... 15.2 Preparation Flowchart ... 15.2 Selecting the Blood Pressure Measuring Device ... 15.2 Blood Pressure Transducers ... 15.3 IBP Connection Cords ... 15.4 JP-940P IBP Connection Box ... 15.4 Installing the Blood Pressure Measuring Device ... 15.5 Connecting Cables to the Monitor ... 15.5 Assembling the Infusion Circuit ... 15.6 Connecting the Dome to the Infusion Circuit ... 15.7 Connecting the Blood Pressure Transducer to the Dome ... 15.8 Adjusting Zero Balance ... 15.9 Zero Balance Mode ... 15.9 Adjusting Zero Balance ... 15.9 Memorizing the Zero Balance Values ... 15.11 Monitoring IBP ... 15.12 IBP Information on the Monitoring Screen ... 15.12 Changing IBP Settings ... 15.13 Changing the IBP Scale ... 15.13 Changing the IBP Alarm Limits ... 15.14 Changing the Sync Source ... 15.15 Selecting Sync Sound Pitch ... 15.16 Selecting the Mode for Calculating IBP ... 15.18 Changing the Waveform Display Mode ... 15.19 Selecting the Numeric Data Display Mode ... 15.20 Changing the Label ... 15.22 Types of Labels ... 15.22 Changing the Labels ... 15.22

Section 16 Temperature Monitoring ... 16C.1 General ... 16.1 Preparing for Temperature Monitoring ... 16.2 Preparation Flowchart ... 16.2 Selecting the Probe ... 16.2 Reusable Probes ... 16.2 Disposable Probe ... 16.3 Temperature Connection Cord ... 16.4 C.10

Operator's Manual BSM-4100

CONTENTS Connecting Cables and Attaching the Probe ... 16.4 Connecting Cable to the Monitor ... 16.4 Attaching the Probe to the Patient ... 16.5 Monitoring Temperature ... 16.7 Temperature Information on the Monitoring Screen ... 16.7 Changing Temperature Settings ... 16.8 Changing the Temperature Display Mode ... 16.8 Changing the Temperature Alarm Limits ... 16.9 Changing the Label ... 16.10 Types of Labels ... 16.11 Types of Labels for Blood Temperature Measured Regions ... 16.11 Changing the Label ... 16.11

Section 17 CO Monitoring ... 17C.1 General ... 17.1 Assembling the Measuring System and Inserting the Catheter into the Patient ... 17.2 Preparation Flowchart ... 17.2 Selecting the Catheter ... 17.2 Types of Catheter ... 17.3 Preparing the Injectate ... 17.4 Usable Injectate ... 17.4 Injectate Temperature and Volume ... 17.4 Measuring the Injectate Temperature ... 17.4 Assembling the Measuring System ... 17.7 Connecting Cables to the Monitor ... 17.7 Measuring System Setup Example ... 17.8 Changing Settings for CO Measurement ... 17.10 Setting the Coefficient Value ... 17.10 Procedure ... 17.10 The Preset Coefficient Value Settings ... 17.11 Changing the Height and Weight ... 17.13 Measuring the Pulmonary Capillary Pressure ... 17.15 Inserting and Retaining the Catheter in the Patient ... 17.15 Inserting Position and Inserting Method ... 17.15 Inserting the Catheter into the Patient and Monitoring Blood Pressure ... 17.15 Entering the PCWP and Other IBP Values ... 17.17 Measuring CO ... 17.19 Before Measurement ... 17.19 Measuring CO ... 17.19 Explanation of Hemodynamics Data ... 17.22 When Measurements Cannot be Performed Correctly ... 17.22 Deleting the Data from the CO Table ... 17.23 Recording Data on the CO MEASURE Window ... 17.24 Adding the Acquired Data to the HEMO LIST Window ... 17.24 CO Value Calculation Equation/Coefficient Value Calculation Value ... 17.26

Section 18 CO2 Monitoring ... 18C.1 General ... 18.1 Mainstream Method ... 18.1 Operator's Manual BSM-4100

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CONTENTS Measurement Error with the TG-900P/TG-920P CO2 Sensor Kit ... 18.2 Preparing for CO2 Monitoring ... 18.4 Preparation Flowchart ... 18.4 Types of CO2 Sensor Kit ... 18.4 Using TG-900P CO2 Sensor Kit ... 18.4 Connecting the CO2 Sensor Kit to the Monitor ... 18.5 Connecting the CO2 Adapter to the Respiration Circuit ... 18.5 Using TG-950P CO2 Sensor Kit ... 18.6 Connecting the CO2 Sensor Kit to the Monitor ... 18.7 Connecting the CO2 Adapter to the Respiration Circuit ... 18.7 Performing Zero Calibration ... 18.8 Using TG-920P CO2 Sensor Kit ... 18.11 Connecting CO2 Sensor Kit to the Monitor ... 18.12 Attaching the CO2 Sensor Kit to the Patient ... 18.12 Monitoring CO2 ... 18.13 CO2 Information on the Monitoring Screen ... 18.14 When Using TG-900P/TG-920P CO2 Sensor Kit ... 18.13 When Using TG-950P CO2 Sensor Kit ... 18.13 Changing CO2 Settings ... 18.15 Changing the CO2 Scale ... 18.15 Changing the Respiration Alarm Limits ... 18.16 Changing the Apnea Alarm Limit ... 18.17 Changing the EtCO2 Alarm Limits ... 18.18 Changing the FiCO2 Alarm Limit ... 18.19 Setting the Inspiration Composition ... 18.21 Changing the CO2 Waveform Sweep Speed ... 18.23 Inspection of Measuring Accuracy ... 18.24 Daily Inspection of Measuring Accuracy ... 18.24 Inspection of Measuring Accuracy (Precise Method) ... 18.24 Checking Procedure ... 18.25

Section 19 FiO2 Monitoring ... 19C.1 General ... 19.1 Preparing for FiO2 Monitoring ... 19.2 Preparation Flowchart ... 19.2 Connecting the Oxygen Sensor to the Monitor ... 19.2 Calibrating the O2 Sensor ... 19.3 Calibration with Air (Simple method) ... 19.3 Calibration with 100% O2 (Precise Method) ... 19.4 Changing the FiO2 Alarm Limits ... 19.5 Connecting the Oxygen Sensor to the Inspiration Circuit and Starting Measurement ... 19.7 Principle and Structure of Oxygen Sensor ... 19.9 Structure of Oxygen Sensor ... 19.9 Life Span of Oxygen Sensor ... 19.9 Precautions when Using the Oxygen Sensor ... 19.10

Section 20 Error Messages and Troubleshooting ... 20C.1 Monitoring ... 20.1 Messages... 20.1 C.12

Operator's Manual BSM-4100

CONTENTS Problems ... 20.2 Network ... 20.3 Messages... 20.3 Problems ... 20.3 Recording ... 20.4 Messages... 20.4 Problems ... 20.4 ECG Monitoring ... 20.5 Messages... 20.5 Problems ... 20.6 Respiration Monitoring ... 20.7 Messages... 20.7 Problems in Impedance Method ... 20.7 Problems in Thermistor Method ... 20.8 SpO2 Monitoring ... 20.9 Messages... 20.9 Problems ... 20.10 NIBP Monitoring ... 20.11 Messages... 20.11 Problems ... 20.12 IBP Monitoring ... 20.13 Messages... 20.13 Problems ... 20.13 Temperature Monitoring ... 20.14 Messages... 20.14 Problems ... 20.14 CO Monitoring ... 20.15 Messages... 20.15 Problems ... 20.16 CO2 Monitoring ... 20.17 Messages... 20.17 Problems ... 20.17 When Using TG-900P/TG-920P CO2 Sensor Kit ... 20.17 When Using TG-950P CO2 Sensor Kit ... 20.18 FiO2 Monitoring ... 20.19 Messages... 20.19 Problems ... 20.19

Section 21 Maintenance ... 21C.1 Calibrating the Touch Screen ... 21.2 Cleaning the Touch Screen ... 21.4 Turning Touchkey Function On or Off ... 21.4 Cleaning the Touch Screen ... 21.5 Handling Accessories After Use ... 21.6 Battery Pack ... 21.6 Battery Lifetime ... 21.6 Replacing Battery Pack ... 21.6 Disposal of Battery Pack ... 21.6

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CONTENTS ECG and Respiration in Impedance Method ... 21.6 Electrode Lifetime ... 21.6 Disposing of Electrodes ... 21.6 Cleaning and Disinfecting the Electrode Lead and ECG Connection Cord ... 21.6 Respiration in Thermistor Method ... 21.7 Cleaning and Disinfecting the Respiration Pickup ... 21.7 SpO2 ... 21.7 Expiration of Disposable Probes ... 21.7 Disposing of Probes ... 21.8 Cleaning and Disinfecting the SpO2 Connection Cord ... 21.8 NIBP ... 21.8 NIBP Cuff Lifetime ... 21.8 Cleaning and Disinfecting the YP-950T/951T/952T/953T/954T/955T/960T/961T/ 962T/963T/964T/965T Reusable Cuffs ... 21.8 Cleaning and Disinfecting the Air Hose and Extension Hose ... 21.9 Disinfecting the Disposable Cuffs ... 21.9 Disposal of Disposable Cuffs ... 21.10 IBP ... 21.10 Cleaning, Disinfecting, Sterilizing and Storing the Blood Pressure Transducer ... 21.10 Disposing of Transducer and Dome ... 21.12 Cleaning and Disinfecting the IBP Connection Cord ... 21.12 Temperature ... 21.13 Cleaning, Disinfecting and Sterilizing the Reusable Probe ... 21.13 Disposal of Disposable Probe ... 21.13 Cleaning and Disinfecting the Temperature Connection Cord ... 21.13 CO ... 21.14 Cleaning and Disinfecting the Catheter and Measuring System ... 21.14 Cleaning and Disinfecting the CO Connection Cord ... 21.14 Disposing of Catheter ... 21.14 CO2 ... 21.14 FiO2 ... 21.15 Lifetime and Replacement of Oxygen Sensor ... 21.15 Cleaning, Disinfecting and Sterilizing the Oxygen Sensor ... 21.15 Storing the Oxygen Sensor ... 21.15 Disposal of the Oxygen Sensor ... 21.15 Cleaning, Disinfecting and Sterilizing the T-shaped Adapter ... 21.16 Cleaning and Disinfecting the FiO2 Connection Cord ... 21.16 Cleaning and Disinfecting the Monitor ... 21.17 Cleaning ... 21.17 Disinfecting ... 21.17 Cleaning the Recorder ... 21.18 Cleaning the Thermal Head ... 21.18 Cleaning the Sensors ... 21.18 Yearly Inspection ... 21.19 Clock Accuracy ... 21.20 Periodical Replacement Schedule ... 21.20 Repair Parts Availability Policy ... 21.20

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CONTENTS

Section 22 Reference ... 22C.1 Factory Default Settings ... 22.1 SYSTEM SETUP Screen ... 22.1 ECG Window ... 22.1 RESP Window ... 22.1 SpO2 Window ... 22.2 NIBP Window ... 22.2 PRESS Window ... 22.2 TEMP Window ... 22.2 CO2 Window ... 22.3 TREND Window ... 22.3 LIST Window ... 22.3 ARRHYTH RECALL Window ... 22.4 ST Window ... 22.4 CO Window ... 22.4 INTERBED Window ... 22.4 RECORDING Window ... 22.4 VITAL ALARM Window ... 22.5 ARRHYTH ALARM Window ... 22.5 DATE & TIME Window ... 22.6 SOUND & BRIGHT Window ... 22.6 DISPLAY Window ... 22.6 FUNCTION KEY Window ... 22.6 DRUG CALCULATE Window ... 22.7 Specifications ... 22.8 Display ... 22.8 Sound ... 22.8 Alarm ... 22.8 ECG ... 22.8 Respiration (Transthoracic impedance pneumography) ... 22.9 SpO2 ... 22.10 Non Invasive Blood pressure, NIBP ... 22.10 Invasive Blood Pressure, IBP ... 22.10 Temperature ... 22.11 Cardiac Output, CO ... 22.11 Respiration (Thermistor method) ... 22.11 Inspired Oxygen Fractional Concentration, FiO2 ... 22.12 Expired Carbon Dioxide Tension, CO2 ... 22.12 Trendgraph ... 22.12 Vital Signs List ... 22.13 Hemodynamics List (BSM-4103/4113 monitors only) ... 22.13 Alarm history ... 22.13 Full Disclosure (QM-421P flash memory card required) ... 22.13 ECG/BP Output ... 22.13 Recorder (BSM-4101/4103 monitors only) ... 22.13 External Output ... 22.13 Clock Accuracy ... 22.14 Power Requirement ... 22.14 Environment ... 22.14

Operator's Manual BSM-4100

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CONTENTS Dimensions and Weight (approximate) ... 22.14 Electromagnetic Compatibility ... 22.14 Safety Standard ... 22.14 Input/Output Socket Pin Assignment ... 22.16 ECG/BP OUT Socket ... 22.16 ZB Socket ... 22.16 AUX Socket ... 22.17 General Requirements for Connecting Medical Electrical System ... 22.18 Standard Accessories ... 22.20 Options and Consumables ... 22.21 Options for the Monitor ... 22.21 For ECG and Respiration (Impedance Method) Monitoring ... 22.22 For Respiration Monitoring (Thermistor method) ... 22.23 For SpO2 Monitoring ... 22.23 For NIBP Monitoring ... 22.24 For IBP Measurement ... 22.25 For Temperature Monitoring ... 22.27 For CO2 Monitoring (Mainstream Method) ... 22.27 For FiO2 Monitoring ... 22.28 For CO Monitoring ... 22.28

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GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel. Use only Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input boxes and AC power. Please read these precautions thoroughly before attempting to operate the instrument. 1. To safely and effectively use the instrument, its operation must be fully understood. 2. When installing or storing the instrument, take the following precautions: (1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly ventilated areas, and dust, saline or sulphuric air. (2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport. (3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. (4) The power line source to be applied to the instrument must correspond in frequency and voltage to product specifications, and have sufficient current capacity. (5) Choose a room where a proper grounding facility is available. 3. Before Operation (1) Check that the instrument is in perfect operating order. (2) Check that the instrument is grounded properly. (3) Check that all cords are connected properly. (4) Pay extra attention when the instrument is combined with other instruments to avoid misdiagnosis or other problems. (5) All circuitry used for direct patient connection must be doubly checked. (6) Check that battery level is acceptable and battery condition is good when using battery-operated models. 4. During Operation (1) Both the instrument and the patient must receive continual, careful attention. (2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety. (3) Avoid direct contact between the instrument housing and the patient. 5. To Shutdown After Use (1) Turn power off with all controls returned to their original positions. (2) Remove the cords gently; do not use force to remove them. (3) Clean the instrument together with all accessories for their next use. 6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order. 7. The instrument must not be altered or modified in any way. 8. Maintenance and Inspection: (1) The instrument and parts must undergo regular maintenance inspection at least every 6 months. (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition. (3) Technical information such as parts list, descriptions, calibration instructions or other information is available for qualified user technical personnel upon request from your Nihon Kohden distributor. Operator's Manual BSM-4100

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9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or location of electrodes and/or transducers to avoid possible burn to the patient. 10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.

WARRANTY POLICY Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from the warranty. NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period, provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals. No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty. Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure. Shipping costs must be pre-paid. This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identification marks have been removed. In the USA and Canada other warranty policies may apply.

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Operator's Manual BSM-4100

EMC RELATED CAUTION This equipment and/or system complies with the International Standard IEC60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in the IEC60601-1-2, can cause harmful interference to the equipment and/or system or cause the equipment and/or system to fail to perform its intended function or degrade its intended performance. Therefore, during the operation of the equipment and/or system, if there is any undesired deviation from its intended operational performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the equipment and/or system. The following describes some common interference sources and remedial actions: 1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or cellular phone: Install the equipment and/or system at another location if it is interfered with by an emitter source such as an authorized radio station. Keep the emitter source such as cellular phone away from the equipment and/or system. 2. Radio-frequency interference from other equipment through the AC power supply of the equipment and/or system: Identify the cause of this interference and if possible remove this interference source. If this is not possible, use a different power supply. 3. Effect of direct or indirect electrostatic discharge: Make sure all users and patients in contact with the equipment and/or system are free from direct or indirect electrostatic energy before using it. 4. Electromagnetic interference with any radio wave receiver such as radio or television: If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or system as far as possible from the radio wave receiver. If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden Corporation subsidiary or distributor for additional suggestions.

The CE mark is a protected conformity mark of the European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC. The CE mark only applies to the BSM-4100K Bedside Monitors.

This equipment complies with International Standard IEC60601-1-2 (1993) which requires CISPR11, Group 1, Class B. Class B EQUIPMENT is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

Operator's Manual BSM-4100

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