Life Scope i and Life Scope L Operators Manual BSM-2300 series

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 panels ... vi On screen ... vii Others ... vii

Section 1

General ... 1C.1 Introduction ... 1.1 Features ... 1.2 Composition ... 1.4 Network Composition ... 1.6 Panel Description ... 1.7 Front Panel ... 1.7 Left Side Panel ... 1.8 BSM-2301/2351 ... 1.8 BSM-2304 ... 1.9 Right Side Panel ... 1.10 Basic Operating Concepts ... 1.12 Screen Displays ... 1.12 Using Touch Screen Keys ... 1.16 Keys on the Front Panel ... 1.18 Using the MENU Window ... 1.18 General Safety Information ... 1.19 General ... 1.19 Installation ... 1.20 Using QI-231P/236P Interface ... 1.21 Using DZ-230P Hooks ... 1.22 Network ... 1.22 Battery ... 1.23 ECG Monitoring ... 1.24 Respiration Monitoring ... 1.26 SpO2 Monitoring ... 1.26 NIBP Monitoring ... 1.29 IBP Monitoring ... 1.30 Temperature Monitoring ... 1.31 CO2 Monitoring ... 1.31 Maintenance ... 1.34

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CONTENTS

Section 2

Preparations ... 2C.1 Preparation Flowchart ... 2.1 Installation Conditions ... 2.2 Preparing the Optional Recorder Module ... 2.4 Installing the Recorder Module ... 2.4 Loading the Recording Paper ... 2.4 Attaching the Optional Hooks ... 2.6 Connecting an External Instrument to the Monitor ... 2.7 Connecting the Monitor to a Network ... 2.8 Inserting the Network Card or Network Printer Card ... 2.9 Removing the Network Card or Network Printer Card ... 2.11 Using the QI-210P Wireless LAN station ... 2.11 Power ... 2.12 AC or Battery Power Source Selection ... 2.12 Connecting the Power Cord and Grounding the Monitor ... 2.12 Connecting the Power Cord ... 2.12 Grounding the Monitor ... 2.13 Turning the Monitor On ... 2.13 Check Before Turning On the Monitor ... 2.13 Turning the Monitor On ... 2.14 Standby Mode ... 2.15 Check After Turning On the Monitor and During Monitoring ... 2.15 Turning the Monitor Off ... 2.16 Check After/Before Turning the Monitor Off ... 2.16 Power and Battery Status Indications ... 2.16 Battery Handling and Operation ... 2.17 Safety Information ... 2.17 Battery Lifetime ... 2.19 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 ... 2.20 Installing or Replacing the Battery ... 2.20 Charging the Battery ... 2.20 Disposal of Battery Pack ... 2.21

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) ... 3.7 Bed ID Setting (BED ID SETUP) ... 3.8 Parameter and Other Settings (PARAMETER SETUP) ... 3.9 Alarm Settings (ALARM SETUP) ... 3.10 Unit Settings (UNITS SETUP) ... 3.14

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CONTENTS Color Settings (COLOR SETUP) ... 3.15 Recording Settings (RECORD SETUP) ... 3.18 Other Settings (OTHER SETUP) ... 3.19 Alarm Master Settings (ALARM MASTER) ... 3.20 Arrhythmia Recall Master Settings (ARRHYTHMIA RECALL MASTER) ... 3.22 Network Settings (NETWORK SETUP) ... 3.23 Network Printer Settings (PRINTER SETUP) ... 3.24 External Interface Information (EXT I/F SETUP) ... 3.26 Initializing the System ... 3.27

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 Name ... 4.8 Displaying the PATIENT INFO Window ... 4.9 Entering the Patient Name Using the Keyboard ... 4.10 Entering the Patient Name Using Free Function ... 4.11 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 Interbed Monitoring ... 5.4 Monitoring Screen ... 5.5 Settings for the Monitoring Screen ... 5.6 Waveform Sweep Mode and Speed ... 5.6 Trendgraph/PWTT trendgraph/OCRG Display on the Monitoring Screen On or Off ... 5.6 Background and Parameter Colors ... 5.7 Waveform Sensitivity ... 5.7 Displaying Other Windows from the Monitoring Screen ... 5.8 Changing Settings for Monitoring Screen ... 5.9 Displaying OCRG ... 5.11 Displaying PWTT Trendgraph ... 5.12 Freezing Waveforms ... 5.13 Using Sleep Mode ... 5.14 Turning Sleep Mode On ... 5.14 Turning Sleep Mode Off ... 5.15

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CONTENTS Displaying the Large Numeric Window ... 5.16

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 an Alarm/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 Respiration Related Alarms ... 6.7 SpO2 Related Alarms ... 6.7 NIBP Related Alarms ... 6.7 IBP Related Alarms ... 6.7 CO2 Related Alarms ... 6.8 Temperature Related Alarms ... 6.8 Other Alarms ... 6.8 Messages ... 6.8 ECG Related Messages ... 6.8 Respiration Related Messages... 6.8 SpO2 Related Messages ... 6.9 NIBP Related Messages ... 6.9 IBP Related Message ... 6.9 Temperature Related Message ... 6.9 CO2 Related Messages ... 6.10 Other Messages ... 6.10 INTERBED ALARM message ... 6.10 Alarm Indications ... 6.11 Overview ... 6.11 Individual Alarm Indications ... 6.11 Vital Signs Alarms ... 6.11 Arrhythmia Alarms ... 6.13 Parameter Alarms ... 6.13 Other Alarms ... 6.15 Alarm Control Marks ... 6.16 Alarm Silence Mark ... 6.16 Alarm Recording Off Mark ... 6.16 Priority of Alarm Control Marks ... 6.16

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CONTENTS Individual Vital Signs Alarm Setting Indication ... 6.16 Adjusting the Alarm Sound Volume ... 6.16 Silencing/Suspending Alarms ... 6.17 Overview ... 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 Automatic 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 Changing the Time Threshold for Apnea Trendgraph ... 7.5 Recording the Trendgraph ... 7.6 Printing the Trendgraph ... 7.6 List Window ... 7.8 Overview ... 7.8 Displaying the LIST Window ... 7.9 Setting the Data Sampling 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 Arrhythmia Recall Window ... 7.14 Overview ... 7.14 Arrhythmia List ... 7.14 Arrhythmia Waveform Annotation ... 7.15 Displaying the Arrhythmia Recall Window ... 7.15 Recording the Arrhythmia Recall Waveform ... 7.16 Printing the Arrhythmia Recall Waveform ... 7.17 Selecting the Arrhythmia Types to be Saved as a Recall File ... 7.19 Alarm History Window ... 7.20 Displaying the ALARM HISTORY Window ... 7.20 Recording the Alarm History Data ... 7.21

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CONTENTS

Section 8

Recording ... 8C.1 Overview of Recording ... 8.1 Recording Modes ... 8.2 Manual Recording/Printing on the Monitoring Screen (Real Time/Delayed Recording) ... 8.3 Manually Recording OCRG on the Monitoring Screen ... 8.3 Manually Recording PWTT trendgraph on the Monitoring Screen ... 8.3 Manually Recording/Printing on the Review Windows ... 8.3 Periodic Recording ... 8.3 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 Recorded/Printed Data ... 8.7 Changing the Recording Pattern ... 8.8 Changing the Recording Sweep Speed ... 8.9 Manually Recording/Printing Waveforms ... 8.10 Recording Waveforms on the Optional Recorder ... 8.10 Recording OCRG on the Optional Recorder ... 8.10 Recording PWTT Trendgraph on the Optional Recorder ... 8.10 Manual Printing on the Network Printer ... 8.11 Setting Periodic Recording ... 8.12 Changing Settings for Automatic Periodic Recording ... 8.13 Printing on a Network Printer ... 8.14

Section 9

Interbed Window... 9C.1 Registering Interbed Beds ... 9.2 Removing an Interbed Bed ... 9.3 Displaying the Interbed Bed Data ... 9.4 Interbed Alarm ... 9.6 Setting Interbed Alarm On or Off ... 9.6

Section 10 ECG Monitoring ... 10C.1 General ... 10.1 Preparing for ECG Monitoring ... 10.2 Preparation Flowchart ... 10.2 Selecting a Lead ... 10.2 Number of Electrodes and Measuring Leads ... 10.3 Electrode Position ... 10.3 3 Electrode Leads ... 10.3 6 Electrode Leads ... 10.4 Selecting Electrodes and Lead ... 10.5 Types of Leads and Connection Cord ... 10.5 Connecting Cables and Attaching Disposable Electrodes ... 10.6 Connecting the Electrode Cable to the Monitor ... 10.6 C.6

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CONTENTS Attaching Disposable Electrodes to the Patient ... 10.7 Monitoring ECG ... 10.8 ECG Information on the Monitoring Screen ... 10.8 Measuring ST Level ... 10.9 Monitoring Arrhythmia ... 10.10 Arrhythmia Analysis Classification Messages ... 10.10 Turning Arrhythmia Analysis On/Off ... 10.11 Learning the ECG Waveform for Arrhythmia Detection (VPC Learning) ... 10.12 Changing the Dominant QRS ... 10.14 Noise Detection and Display ... 10.15 Detached Electrode Detection and Display ... 10.16 Changing ECG Settings ... 10.17 Changing the Monitoring Lead ... 10.17 Changing the ECG Sensitivity ... 10.20 Changing the Heart Rate or Pulse Rate and ST Alarm Limits ... 10.21 Changing the Arrhythmia Alarm Setting ... 10.22 Changing the Type of Electrode Cable and Leads ... 10.24 Changing the Sync Source ... 10.26 Turning the Filters On/Off ... 10.27 Selecting the Mode for Updating the Heart Rate ... 10.29 Turning Pacing Spike Detection On/Off ... 10.30 Displaying the Pacing Mark on the ECG ... 10.32 Use with an Electrosurgical Unit ... 10.33

Section 11 Respiration Monitoring... 11C.1 General ... 11.1 Measurement Method ... 11.1 Impedance Method ... 11.1 Thermistor Method ... 11.2 Preparing for Respiration Monitoring in Impedance Method ... 11.3 Preparation Flowchart ... 11.3 Electrode Position and Waveform Examples ... 11.4 Connecting Cables and Attaching Disposable Electrodes ... 11.6 Preparing for Respiration Monitoring in Thermistor Method ... 11.7 Preparation Flowchart ... 11.7 Respiration Pickups ... 11.7 Connecting the Cable to the Monitor ... 11.8 Attaching the Respiration Pickup ... 11.8 When Using Respiration Pickup for Airway ... 11.8 When Using Respiration Pickup for Nose ... 11.9 Monitoring Respiration ... 11.10 Respiration Information on the Monitoring Screen ... 11.10 Changing Respiration Settings ... 11.12 Turning Respiration Monitoring On or Off in Impedance Method ... 11.12 Changing the Monitoring Lead in Impedance Method ... 11.14 Changing the Respiration Sensitivity ... 11.15 Changing the Respiration Waveform Sweep Speed ... 11.16 Changing the Apnea Alarm Limit ... 11.17

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CONTENTS Changing the Respiration Alarm Limits ... 11.18

Section 12 SpO2 Monitoring ... 12C.1 General ... 12.1 Preparing for SpO2 Monitoring ... 12.2 Preparation Flowchart ... 12.2 Selecting a Probe ... 12.3 Nihon Kohden Reusable Probes ... 12.3 Nihon Kohden Disposable Probes ... 12.4 Nellcor SpO2 Probes ... 12.5 Connecting Cables ... 12.6 Connecting Cable to the Monitor ... 12.6 Attaching the Probe to the Patient ... 12.7 Monitoring SpO2 ... 12.9 SpO2 Information on the Monitoring Screen ... 12.10 Detection and Display of Measurement Condition ... 12.11 CHECK PROBE Message (When the Finger Probe is Used) ... 12.11 DETECTING PULSE Message ... 12.11 M Message ... 12.11 Changing SpO2 Settings ... 12.12 Changing the Pulse Waveform Sensitivity ... 12.12 Changing the SpO2 Alarm Limits ... 12.14 Changing the Sync Source ... 12.15 Selecting Sync Sound Pitch ... 12.16 Selecting the Response Mode ... 12.18

Section 13 NIBP Monitoring ... 13C.1 General ... 13.1 Oscillometric Method ... 13.1 Measurement Modes... 13.1 Preparing for NIBP Measurement ... 13.2 Preparation Flowchart ... 13.2 Selecting the Cuff ... 13.2 Cuff Width and Arm Circumference ... 13.3 Types of Cuffs ... 13.4 Reusable Cuffs ... 13.4 Disposable Cuffs ... 13.6 Disinfecting Disposable Cuffs before Use ... 13.7 Connecting Cables and Attaching the Cuff to the Patient ... 13.7 Connecting Air Hose and Cuff to the Monitor ... 13.7 Attaching the Cuff to the Patient ... 13.9 Changing NIBP Settings ... 13.11 Selecting the Initial Cuff Inflation Pressure ... 13.11 Selecting the Measurement Mode and Interval ... 13.13 Selecting the Measurement Modes for the Mode Selection by the NIBP INTERVAL Key ... 13.14 Measurement Modes... 13.16 C.8

Operator's Manual BSM-2300A

CONTENTS Changing the NIBP Alarm Settings ... 13.19 Changing the PWTT Settings ... 13.20 Measuring and Monitoring NIBP ... 13.22 Recommended Patient State ... 13.22 Starting and Stopping NIBP Measurement ... 13.23 Manual Mode ... 13.23 STAT (Continuous) Mode ... 13.23 Auto Mode ... 13.23 NIBP Information on the Monitoring Screen ... 13.24 Dimming and Hiding the NIBP Data ... 13.24

Section 14 IBP Monitoring ... 14C.1 General ... 14.1 Preparing for Blood Pressure Monitoring ... 14.2 Preparation Flowchart ... 14.2 Selecting the Blood Pressure Measuring Device ... 14.2 Blood Pressure Transducers ... 14.3 IBP Connection Cords ... 14.4 Installing the Blood Pressure Measuring Device ... 14.5 Connecting Cables to the Monitor ... 14.5 Assembling the Infusion Circuit ... 14.6 Connecting the Dome to the Infusion Circuit ... 14.7 Connecting the Blood Pressure Transducer to the Dome ... 14.8 Adjusting Zero Balance ... 14.9 Adjusting Zero Balance ... 14.9 Monitoring IBP ... 14.12 IBP Information on the Monitoring Screen ... 14.12 Changing IBP Settings ... 14.13 Changing the IBP Alarm Limits ... 14.13 Changing the IBP Scale ... 14.14 Changing the Sync Source ... 14.16 Selecting Sync Sound Pitch ... 14.17 Selecting the Mode for Calculating IBP ... 14.19 Selecting the Data Display Mode ... 14.20 Changing the IBP Waveform Display Mode ... 14.21 Changing the Label ... 14.23 Types of Labels ... 14.23 Changing the Labels ... 14.23

Section 15 CO2 Monitoring ... 15C.1 General ... 15.1 Mainstream Method ... 15.1 Measurement Error with the TG-900P/TG-920P CO2 Sensor Kit ... 15.2 Preparing for CO2 Monitoring ... 15.4 Preparation Flowchart ... 15.4 Types of CO2 Sensor Kit ... 15.4 Using TG-900P CO2 Sensor Kit ... 15.4 Operator's Manual BSM-2300A

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CONTENTS Connecting the CO2 Sensor Kit to the Monitor ... 15.5 Connecting the CO2 Adapter to the Respiration Circuit ... 15.5 Using TG-950P CO2 Sensor Kit ... 15.6 Connecting the CO2 Sensor Kit to the Monitor ... 15.7 Connecting the CO2 Adapter to the Respiration Circuit ... 15.7 Performing Zero Calibration ... 15.8 Using TG-920P CO2 Sensor Kit ... 15.11 Connecting CO2 Sensor Kit to the Monitor ... 15.12 Attaching the CO2 Sensor Kit to the Patient ... 15.12 Monitoring CO2 ... 15.13 CO2 Information on the Monitoring Screen ... 15.14 Changing CO2 Settings ... 15.15 Changing the Respiration Alarm Limits ... 15.15 Changing the Apnea Alarm Limit ... 15.16 Changing the EtCO2 Alarm Limits ... 15.17 Changing the FiCO2 Alarm Limits ... 15.18 Changing the CO2 Scale ... 15.20 Changing the CO2 Waveform Sweep Speed ... 15.21 Setting the Inspiration Composition ... 15.22 Inspection of Measuring Accuracy ... 15.24 Daily Inspection of Measuring Accuracy ... 15.24 Inspection of Measuring Accuracy (Precise Method) ... 15.24 Checking Procedure ... 15.25

Section 16 Temperature Monitoring ... 16C.1 General ... 16.1 Preparing for Temperature Monitoring ... 16.1 Preparation Flowchart ... 16.1 Selecting the Probe ... 16.2 Reusable Probes ... 16.2 Disposable Probe ... 16.3 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 Alarm Limits ... 16.8

Section 17 Error Messages and Troubleshooting ... 17C.1 Monitoring ... 17.1 Messages ... 17.1 Problems ... 17.2 Network ... 17.3 Messages ... 17.3 Problems ... 17.4 Recording (When Using an Optional Recorder Module) ... 17.5 C.10

Operator's Manual BSM-2300A

CONTENTS Messages ... 17.5 Problems ... 17.5 Printing ... 17.6 Messages ... 17.6 Problems ... 17.6 ECG Monitoring ... 17.7 Messages ... 17.7 Problems ... 17.8 Respiration Monitoring ... 17.9 Messages ... 17.9 Problems in Impedance Method ... 17.9 Problems in Thermistor Method ... 17.10 SpO2 Monitoring ... 17.11 Messages ... 17.11 Problems ... 17.12 NIBP Monitoring ... 17.13 Messages ... 17.13 Problems ... 17.14 IBP Monitoring ... 17.15 Messages ... 17.15 Problems ... 17.15 Temperature Monitoring ... 17.16 Messages ... 17.16 Problems ... 17.16 CO2 Monitoring ... 17.17 Messages ... 17.17 Problems ... 17.17

Section 18 Maintenance ... 18C.1 Calibrating Waveforms ... 18.2 Calibrating the Touch Screen ... 18.3 Cleaning the Touch Screen ... 18.5 Turning Touch Key Function On or Off ... 18.5 Cleaning the Touch Screen ... 18.6 Handling Accessories After Use ... 18.7 Battery Pack ... 18.7 Battery Lifetime ... 18.7 Replacing Battery Pack ... 18.7 Disposal of Battery Pack ... 18.7 ECG and Respiration in Impedance Method ... 18.7 Electrode ... 18.7 Disposing of Electrodes ... 18.7 Cleaning and Disinfecting the Electrode Lead and ECG Connection Cord ... 18.7 Respiration in Thermistor Method ... 18.8 Cleaning and Disinfecting the Respiration Pickup ... 18.8 SpO2 ... 18.8 Expiration of Nihon Kohden Disposable Probes ... 18.8 Disposing of Probes ... 18.8 Cleaning and Disinfecting the SpO2 Connection Cord ... 18.9 Operator's Manual BSM-2300A

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CONTENTS NIBP ... 18.9 NIBP Cuff Lifetime ... 18.9 Cleaning and Disinfecting the YP-950T/951T/952T/953T/954T/955T/960T/961T/ 962T/963T/964T/965T Reusable Cuffs ... 18.9 Cleaning and Disinfecting the YP-900P/901P/902P/903P/904P/905P/906P Reusable Cuffs ... 18.10 Cleaning and Disinfecting the Air Hose and Extension Hose ... 18.10 Disinfecting the Disposable Cuffs ... 18.11 Disposal of Cuffs ... 18.11 IBP ... 18.11 Cleaning, Disinfecting, Sterilizing and Storing the Blood Pressure Transducer ... 18.11 Disposing of Transducer and Dome ... 18.13 Cleaning and Disinfecting the IBP Connection Cord ... 18.14 Temperature ... 18.14 Cleaning, Disinfecting and Sterilizing the Reusable Probe ... 18.14 Disposal of Disposable Probe ... 18.14 CO2 ... 18.14 Cleaning and Disinfecting the Monitor ... 18.15 Cleaning ... 18.15 Disinfecting ... 18.15 Cleaning the Recorder Module ... 18.16 Cleaning the Thermal Head ... 18.16 Cleaning the Sensors ... 18.16 Yearly Inspection ... 18.17 Clock Accuracy ... 18.18 Periodical Replacement Schedule ... 18.19 Repair Parts Availability Policy ... 18.19

Section 19 Reference ... 19C.1 Factory Default Settings ... 19.1 SYSTEM SETUP Screen ... 19.1 ECG Window ... 19.1 RESP Window ... 19.1 SpO2 Window ... 19.2 NIBP Window ... 19.2 PRESS Window ... 19.2 CO2 Window ... 19.3 TREND Window ... 19.3 LIST Window ... 19.3 ARRHYTH RECALL Window ... 19.4 VITAL ALARM Window ... 19.4 ARRHYTH ALARM Window ... 19.5 RECORDING Window ... 19.5 DATE & TIME Window ... 19.5 SOUND & BRIGHT Window ... 19.5 DISPLAY Window ... 19.6 FUNCTION KEY Window ... 19.6 INTERBED Window ... 19.6 C.12

Operator's Manual BSM-2300A

CONTENTS Specifications ... 19.7 Display ... 19.7 Sound... 19.7 Alarm ... 19.7 ECG ... 19.7 Respiration (Transthoracic impedance pneumography) ... 19.8 SpO2 on BSM-2301/2351 ... 19.9 SpO2 on BSM-2304 ... 19.9 Non Invasive Blood pressure, NIBP ... 19.9 Temperature ... 19.10 Multi-parameter Amplifier ... 19.10 Invasive Blood Pressure, IBP ... 19.10 Respiration (Thermistor method) ... 19.11 Expired Carbon Dioxide Tension, CO2 ... 19.11 Trendgraph ... 19.11 Vital Signs List ... 19.11 Recorder Module (optional, WS-231P) ... 19.12 External Output ... 19.12 Power Requirement ... 19.12 Clock Accuracy ... 19.12 Environment ... 19.12 Dimensions and Weight ... 19.13 Electromagnetic Compatibility ... 19.13 Safety Standard ... 19.13 Input/Output Socket Pin Assignment ... 19.14 AUX Socket ... 19.14 General Requirements for Connecting Medical Electrical System ... 19.15 Standard Accessories ... 19.17 Options and Consumables ... 19.18 Options for the Monitor ... 19.18 For ECG and Respiration (Impedance Method) Monitoring ... 19.18 For Respiration Monitoring (Thermistor method) ... 19.18 For SpO2 Monitoring ... 19.19 For NIBP Monitoring ... 19.20 For IBP Measurement ... 19.21 For Temperature Monitoring ... 19.23 For CO2 Monitoring (Mainstream Method) ... 19.23 For WS-231P Recorder Module ... 19.23

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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.

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(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. 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.

CAUTION United States law restricts this device to sale by or on the order of physician.

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EMC RELATED CAUTION This equipment and/or system complies with the International Standard IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in the IEC 60601-1-2, 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. A humid room can help lessen this problem. 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.

This equipment complies with International Standard IEC 60601-1-2 (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.

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In IEC 60601-1-2 Medical Electronic Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard: Electromagnetic compatibility-Requirements and test. Section 36. 202. 2 Radiated radiofrequency electromagnetic fields, PATIENT COUPLED EQUIPMENT and/or SYSTEMS applicable IMMUNITY test methods are under consideration at SC62A/WG13. The 3 V/m IMMUNITY level may be inappropriate especially when measuring SpO2 because physiological signals can be much smaller than those induced by a 3 V/m electromagnetic field. When measuring SpO2, various interference may produce false waveforms which look like pulse waveforms. SpO2 value and pulse rate may be measured from these false waveforms, causing the alarm to function improperly. When installing the monitor, avoid locations where the monitor may receive strong electromagnetic interference such as radio or TV stations, cellular phone or mobile two-way radios.

WARNING Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic Equipment* The bioelectric impedance measurement sensor of a minute ventilation rate-adaptive implantable pacemaker may be affected by cardiac monitoring and diagnostic equipment which is connected to the same patient. If this occurs, the pacemaker may pace at its maximum rate and give incorrect data to the monitor or diagnostic equipment. If this occurs, disconnect the monitor or diagnostic equipment from the patient or change the setting on the pacemaker by referring to the pacemaker’s manual. For more details, contact your pacemaker distributor or Nihon Kohden distributor.

* Minute ventilation is sensed in rate-adaptive pacemakers by a technology known as bioelectric impedance measurement (BIM). Many medical devices in addition to pacemakers use this technology. When one of these devices is used on a patient with an active, minute ventilation rate-adaptive pacemaker, the pacemaker may erroneously interpret the mixture of BIM signals created in the patient, resulting in an elevated pacing rate. For more information, see the FDA web site. http://www.fda.gov/cdrh/safety.html

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Conventions Used in this Manual and Instrument Warnings, Cautions and Notes Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.

WARNING A warning alerts the user to possible injury or death associated with the use or misuse of the instrument.

CAUTION A caution alerts the user to possible injury or problems with the instrument associated with its use or misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other property.

NOTE A note provides specific information, in the form of recommendations, prerequirements, alternative methods or supplemental information.

Operator's Manual BSM-2300A

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Explanations of the Symbols in this Manual and Instrument The following symbols found in this manual/instrument bear the respective descriptions as given. On panels Symbol

Description

Symbol

Description

AC operation

Defibrillation-proof type BF applied part

“On” only for a part of instrument

Data input/output

“Off” only for a part of instrument

Input/output terminal

Battery operation

Output terminal

Battery charging

Alternating current

Alarm suspend

Equipotential terminal

NIBP

Year of manufacture

NIBP interval

Serial number

NIBP start

IPX4

Splash-proof equipment

NIBP stop

IPX7

Watertight equipment

Menu

Protective earth

Home (monitoring screen)

High voltage

Attention, consult operator’s manual

Record start/stop (on the WS-231P recorder module)

Defibrillation-proof type CF applied part

Out of paper (on the WS-231P recorder module)

CSA mark

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Operator's Manual BSM-2300A