Life Scope BSM-3000 series Operators Manual Tenth Edition Jan 2015

In order to use this product safely and fully understand all its functions, make sure to read this manual before using the product. Keep this manual near the instrument or in the reach of the operator and refer to it whenever the operation is unclear. This product stores personal patient information. Manage and operate the information appropriately. Patient names on the screen shots and recording examples in this manual are fictional and any resemblance to any person living or dead is purely coincidental. The contents of this manual are subject to change without notice. If you have any comments or suggestions on this manual, please contact us at: www.nihonkohden.com

Copyright Notice The entire contents of this manual are copyrighted by Nihon Kohden. All rights are reserved. No part of this document may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded, or otherwise) without the prior written permission of Nihon Kohden.

Trademark

The mark printed on the SD card that is used in this instrument is a trademark. The company name and model name are trademarks and registered trademarks of each company.

Contents About this Manual... 1 Related Documentation... 1 Intended Purpose... 2 Precautions... 4 General Handling Precautions... 4 EMC Related Caution... 4 Other Caution... 5 Responsibility of the Manufacturer... 6 Conventions Used in this Manual and Instrument... 6 Warnings, Cautions and Notes... 6 Text Conventions... 6 Explanations of the Symbols in this Manual and Instrument... 7 General Safety Information... 9 Panel Description... 12 BSM-3532/BSM-3552/BSM-3562/BSM-3572 Bedside Monitor... 12 Front Panel... 12 Left Side Panel... 12 Right Side Panel... 13 Rear Panel... 14 BSM-3733/BSM-3753/BSM-3763/BSM-3773 Bedside Monitor... 15 Front Panel... 15 Left Side Panel... 15 Right Side Panel... 16 Rear Panel... 17 Installation... 18 General... 18 Grounding the Monitor... 19 Environment for External Instruments... 19 Warnings and Cautions for Connecting the Monitor to a Network... 20 Inserting and Removing the Battery Pack... 20 Loading Recording Paper... 21 Turning the Monitor On or Off... 22 Turning the Monitor On... 22 Check Before Turning On the Power... 22 Check After Turning On the Power and During Monitoring... 23 Power and Battery Status Indications... 24 Battery Pack Handling and Operation... 25 Charging the Battery Pack... 26 Stored Data Status at Power On... 27 Monitor Status on Power Interruption... 27 Turning the Monitor Off... 28 Operator’s Manual BSM-3000

Check After or Before Turning the Power Off... 28 Basic Operation... 29 Using the Hard Keys on the Bedside Monitor and Touch Screen... 29 Using the Remote Control... 29 Home Screen Description... 30 Settings for the Home Screen... 31 Trendgraph on the Home Screen (Current Trendgraph)... 32 OCRG... 32 Freezing Waveforms... 32 Using Sleep Mode... 32 Using the Timer... 33 MENU Window Description... 34 Changing Settings... 35 Administrator Settings... 35 Changing Parameter Settings and Other Settings...35 Changing Settings... 35 Changing Settings on the VOLUME Window... 36 Admitting/Discharging Patient... 37 Admitting a Patient... 37 Discharging a Patient... 39 Stored Data Status and Screen Transition for Admitting Patient... 39 Alarms... 41 Alarm Types and Levels... 41 Alarm Control Marks... 42 Flow of Alarm Function... 43 Silencing/Suspending Alarms... 44 Silencing Alarms... 44 Suspending Alarms... 44 Canceling Technical Alarms... 47 Alarm Sound Volume... 47 Alarm Recording... 47 Alarm Setting... 47 Changing Vital Sign Upper/Lower Alarm Limits... 49 Changing the Arrhythmia Alarm Settings... 52 Alarm Escalation... 53 Interbed Alarm... 54 Review Windows... 55 General... 55 Event Bar... 56 TREND Window... 57 GRAPH 1, GRAPH 2, GRAPH 3 Page... 57 TABLE 1, TABLE 2, TABLE 3 Page... 58 C.1

NIBP TREND Page... 59 HEMO TREND Page... 60 Registering the Acquired Data to the Hemodynamics Table... 60 LUNG TREND Page... 61 RECALL Window... 62 ARRHYTH HISTORY Page... 62 ALARM HISTORY Window... 63 ALARM HISTORY Page... 63 FULL DISC Window... 64 FULL DISC Page... 64 ST Window... 65 ST INTERVAL Page... 65 OCRG Window... 66 12 LEAD/12 LEAD ANALYSIS Windows... 67 General... 67 12 LEAD ANALYSIS Window... 67 Performing 12 Lead ECG Interpretation... 67 12 LEAD Window... 69 Viewing the 12 Lead Analysis Result... 69 DRUG/LUNG FUNCTION Windows... 71 DRUG Window... 71 LUNG FUNCTION Window... 73 Recording... 75 Recording Modes... 75 When More than One Recording Modes is Triggered... 75 Changing Recording Settings... 75 Selecting Recording Waveforms... 76 Changing Recording Speed... 76 Selecting Recording Interval for Periodic Recording... 76 Turning Alarm Recording On or Off... 76 INTERBED Window... 77 Registering/Removing Interbed Beds... 77 Displaying the Interbed Bed Data... 78 Interbed Alarm Function... 79 Interbed Alarm Setting... 79 Monitoring Parameters... 81 ECG... 81 Preparation... 81 Monitoring Arrhythmia... 84 Changing ECG Settings... 86 Respiration... 93 Preparation... 93 Changing Respiration Settings... 93 CO2 ... 95 Preparation... 96 Changing CO2 Settings... 99 Inspection of Measuring Accuracy... 102 C.2

Use with Volatile Anesthetic Agents... 102 SpO2 with Nihon Kohden Probes (BSM-3562/ BSM-3572/BSM-3763/BSM-3773)... 103 Silencing SpO2 Alarm... 104 Preparation... 104 Changing SpO2 Settings... 106 SpO2 with Nellcor Probes (BSM-3552/ BSM-3753)... 109 Silencing SpO2 Alarm... 110 Preparation... 110 Changing SpO2 Settings... 112 SpO2 with Masimo Probes (BSM-3532/ BSM-3733)... 114 Silencing SpO2 Alarm... 115 Preparation... 115 Changing SpO2 Settings... 118 NIBP... 121 Preparation... 121 Changing NIBP Settings... 123 Starting and Stopping NIBP Measurement... 125 IBP... 129 Preparation... 129 Connecting Cables to the Monitor... 129 Assembling the Transducer... 130 Adjusting Zero Balance... 131 CHECK ZERO Page... 132 Changing IBP Settings... 132 Temperature... 137 Preparation... 137 Using the Insulation Pad... 138 Changing Temperature Settings... 138 BIS... 140 Preparation... 140 Changing the BIS Settings... 143 Cardiac Output... 146 Preparation... 146 Measuring the Pulmonary Capillary Wedge Pressure... 147 Measuring Cardiac Output... 148 Deleting the Data from the CO Table ... 151 Adding the Acquired Data to the HEMO TREND Page of the TREND Window... 152 Gas... 153 Preparation... 153 Changing Gas Settings... 153 Inspection of Measuring Accuracy... 156 CCO... 157 Preparation... 157 Changing the CCO Settings... 158 Other Parameters... 160 Operator’s Manual BSM-3000

Screen Messages... 163 Troubleshooting... 179 Monitoring... 179 Network... 180 Remote Control... 180 Recording... 180 Printing... 181 ECG... 181 Respiration... 182 CO2 ... 182 Mainstream Method... 182 Sidestream Method... 183 When Using Microcap® Monitor... 183 SpO2 ... 184 NIBP... 185 IBP... 186 Temperature... 186 BIS... 186 When Using BIS Processor/BISx... 186 When Using BIS Monitor... 186 Cardiac Output... 186 Gas... 187 When Using AG-920R Multigas Unit... 187 When Using GF-110PA Multigas Unit or GF-120PA Multigas/Flow Unit... 187 When Using GF-210R Multigas Unit or GF-220R Multigas/Flow Unit... 188 Ventilation... 190 TOF... 190 CCO... 190 When Using APCO/IBP Processor... 190 When Using PiCCO Monitor... 191 When Using Other CCO Monitors... 191 FLOW/Paw... 192 When Using GF-110PA Multigas/Flow Unit... 192 When Using GF-220R Multigas/Flow Unit... 192 EEG... 193 tcPO2/tcPCO2 ... 193 rSO2 ... 194 Anesthesia... 194 Transmitter... 194 12 Lead ECG... 194 Maintenance... 195 BSM-3000 series Bedside Monitor... 195 Cleaning and Disinfecting the Monitor... 195 Cleaning the Touch Screen... 196 Disposing of the Monitor... 196 WS-371P Recorder Module... 197 Cleaning the Thermal Head... 197 Cleaning the Sensors... 197 Operator’s Manual BSM-3000

Disposing of the Recorder Module... 197 SB-671P Battery Pack... 197 Battery Lifetime... 197 Replacing the Batteries... 197 Disposing of Batteries... 197 RY-910PA Remote Controller... 197 Cleaning and Disinfecting the Remote Controller... 197 Disposing of the Remote Controller... 197 Replacing the Batteries... 198 Disposing of Batteries... 198 QF series Interface and IF series Communication Cable... 198 Cleaning and Disinfecting the Interface and Communication Cable... 198 Disposing of the Interface and Communication Cable... 198 Leads, Cables and Cords... 198 Cleaning the Leads, Cables and Cords... 198 Disinfecting the Leads, Cables and Cords... 198 Disposing of Leads, Cables and Cords... 198 Electrodes, Probes, Cuffs, Thermistors, Transducers, Catheters and Other Consumables... 198 Yearly Inspection... 199 Periodic Inspection... 199 Safety Information for Maintenance on Optional Units... 200 AG-920R, GF-110PA or GF-210R Multigas Unit and GF-120PA or GF-220R Multigas/ Flow Unit... 200 AG-400R CO2 Unit... 200 AE-918P Neuro Unit... 201 Specifications... 202 Measuring Parameters... 202 Influence on Measuring Accuracy by Electrosurgery/Defibrillation/Electrostatic Discharge... 202 Display... 202 Alarm... 203 Alarm Delay Time... 203 ECG... 204 Respiration (Transthoracic Impedance Pneumography)... 207 SpO2 ... 207 Non Invasive Blood Pressure, NIBP... 210 Multi Socket... 210 Invasive Blood Pressure, IBP... 211 Temperature... 211 Carbon Dioxide, CO2 (Mainstream Method)... 212 C.3

Cardiac Output, CO... 213 Bispectral Index, BIS... 213 ECG/BP Output (When QI-372P is Connected)... 214 RGB Socket (When QI-372P is Connected)... 214 RS-232C Socket (When QI-373P is Connected)... 214 Nurse Call Socket (When QI-373P is Connected)... 214 When WS-371P Recorder Module is Connected... 214 When ZS-900P Transmitter is Connected... 215 Gas... 215 Carbon Dioxide, CO2 (Sidestream Method)... 218 FLOW/Paw... 218 EEG... 219 CCO... 220 Battery (SB-671P Battery Pack)... 220 Power Requirement... 221 Clock Accuracy... 221 Environment... 221 Mechanical Strength... 221 Electromagnetic Compatibility... 221 Safety Standard... 221 Dimensions and Weight (Approximate)... 222 Electromagnetic Emissions... 223 Electromagnetic Immunity... 224 Recommended Separation Distances between Portable and Mobile RF Communications Equipment... 226 System Composition for EMC Test... 227 Factory Default Settings... 228 Event Bar... 228 TREND Window... 229 RECALL Window... 232 FULL DISC Window... 232 ST Window... 232 OCRG Window... 233 ADMIT DISCHARGE Window... 233 ALARM LIMITS Window... 234 Vital Signs Alarms... 234 Arrhythmia Alarms... 239 DATE Window... 240 VOLUME Window... 240 DISPLAY Window... 240 RECORD Window... 240 ECG Window... 241 RESP/CO2 Window... 242 SpO2 Window... 242 NIBP Window... 243 PRESS Window... 244 TEMP Window... 245 BIS Window... 245 C.4

CO Window... 245 Gas Window... 246 VENT Window... 246 CCO Window... 247 FLOW/Paw Window... 247 EEG Window... 248 ANALOG Window... 249 rSO2 Window... 249 12 LEAD ANALYSIS Window... 249 DRUG Window... 250 LUNG FUNCTION Window... 252 INTERBED Window... 252 Standard Accessories... 253 Op No. 32A, 52A, 72A, 33A, 53A and 73A... 253 Op No. 32K, 52K, 62K, 72K, 33K, 53K 63K and 73K... 253 Options/Consumables... 254 Accessory Set... 254 Op No. 32A, 52A, 72A, 33A, 53A and 73A... 255 Op No. 32K, 52K, 62K, 72K, 33K, 53K 63K and 73K... 255 Units and Modules... 256 Network... 256 Interfaces and Cables for External Instruments... 256 Cart and Attaching Parts... 258 For ECG and Respiration (Impedance Method) Monitoring... 258 For CO2 Monitoring (Mainstream Method)... 259 For SpO2 Monitoring... 260 For NIBP Monitoring... 261 For IBP Monitoring... 262 For Temperature Monitoring... 263 For BIS Monitoring (Using the BIS Processor/ BISx)... 263 For CO Monitoring... 264 For CCO Monitoring... 264 For CO2 Sidestream Monitoring... 264 For BIS Monitoring (Using the BIS Monitor)... 264 For Anesthetic Agent Monitoring... 264 For FLOW/Paw Monitoring... 264 For EEG Monitoring... 264 General Requirements for Connecting Medical Electrical Systems... 265

Operator’s Manual BSM-3000

About this Manual This Operator’s Manual describes the most common features and functions of the BSM-3532/3552/3562/ 3572 and BSM-3733/3753/3763/3773 bedside monitors.

Related Documentation The BSM-3532/3552/3562/3572 and BSM-3733/3753/3763/3773 bedside monitors come with the following manuals in addition to the Operator’s Manual. Administrator’s Guide Describes how to install the bedside monitor. It also explains about the password protected settings on the SYSTEM SETUP window and SYSTEM CONFIGURATION screen which only an administrator can change. User’s Guide, Part I Gives supplemental information on the operation of the bedside monitor. User’s Guide, Part II Describes the features and settings of the monitoring parameters. Service Manual Describes information on servicing the bedside monitor. Only qualified service personnel can service the bedside monitor.

Operator’s Manual BSM-3000

1

Intended Purpose The BSM-3532/3552/3562/3572 and BSM-3733/3753/3763/3773 bedside monitors are for one patient. The BSM-3532/3552/3562/3572 bedside monitors have a 12.1-inch TFT color display, and the BSM3733/3753/3763/3773 bedside monitors have a 15-inch TFT color display. All the monitors can display 15 waveforms on the screen. The bedside monitors are to be installed near the patient. ECG, respiration in impedance method, SpO2, NIBP, IBP, temperature, CO2 of all hospital patients can be monitored and alarms are generated.* The monitor is designed so the operator can directly touch the screen from the operator position. * Essential performance in EMC standard.

WARNING

WARNING

Do not use the same monitor for more than one patient at the same time. Do not connect different sensors from different patients to the same monitor.

Do not diagnose a patient based only on data acquired by the bedside monitor. Overall judgement must be performed by a physician who understands the features, limitations and characteristics of the bedside monitor and by reading the biomedical signals acquired by other instruments.

NOTE: • This monitor must be used by qualified medical personnel with a full knowledge of operating this monitor. • Upgrade the bedside monitor to the Nihon Kohden recommended software version. If more than one BSM-3000 series bedside monitor is used in the same facility, make sure the bedside monitors have the same software version. If the BSM-3000 series monitors with different software versions are used together, correct system operation cannot be guaranteed. • The ALARM CAP function is available on the following bedside monitors, central monitors and multiple patient receivers. - Op No. 32A, 52A, 72A, 33A, 53A and 73A of BSM-3000 series software version 04-12 or later - BSM-6000A series software version 04-01 or later - BSM-9101A software version 13-03 or later - CNS-9701A software version 01-95 or later - ORG-9100A/ORG-9110A software version 03-06 or later - ORG-9700A software version 03-06 or later For details on ALARM CAP function, refer to manual for each instrument of the above and Section 3 of the BSM-3000 series Administrator’s Guide. • Only use Nihon Kohden parts and accessories to assure maximum performance from your instrument.

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Operator’s Manual BSM-3000

Composition • Bedside Monitor Bedside Monitor Model No. of MULTI sockets Available parameters using MULTI sockets No. of TEMP sockets ECG measurement using 10 electrodes 12 lead analysis SpO2 probe NIBP PWTT measurement Analog ECG*2 Analog BP*2 Heart rate trigger output*2

BSM-3532 BSM-3733 BSM-3552 BSM-3753 2

3

2

3

BSM-3562*1 BSM-3572 2

BSM-3763*1 BSM-3773 3

CO2, IBP, BIS, CO, CCO (APCO) 2 Yes Yes Nellcor

Masimo No

Nihon Kohden Yes

Yes

*1 These monitors are not available in USA. *2 The QI-372P interface is required. • QI-372P interface (includes the two Multi-link, RGB and ECG/BP OUT sockets) For BSM-3532-Q01, BSM-3552-Q01, BSM-3562-Q01, BSM-3572-Q01, BSM-3733-Q01, BSM-3753-Q01, BSM-3763-Q01 and BSM-3773-Q01, this interface is installed at the factory. • QI-373P interface (includes the two Multi-link, Nurse call and RS-232C sockets) • WS-371P recorder module • SB-671P battery pack For simplicity, the model number suffix A/G/K is omitted in this manual. Illustrations in this manual are BSM-3733 bedside monitor unless otherwise specified. The option number (Op No.) is printed on the name plate on the rear panel of the monitor.

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3

Precautions General Handling Precautions • This device is intended for use only by qualified medical personnel. • Only use 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, extension cables, electrode leads and AC power. • This device must receive expert, professional attention for maintenance and repairs. When the device is not functioning properly, it should be clearly marked to avoid operation while it is out of order. • This device must not be altered or modified in any way. • The instrument and specified parts must undergo regular maintenance inspection at the interval which is specified after the “General Handling Precautions” section.

EMC Related Caution This equipment and/or system complies with IEC 60601-1-2 International Standard for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in 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. Keep the emitter source such as cellular phone away from the equipment and/or system, or turn off the cellular phone. 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.

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Operator’s Manual BSM-3000

5. Interference of lightning: When lightning occurs near the location where the equipment and/or system is installed, it may induce an excessive voltage in the equipment and/or system. In such a case, disconnect the AC power cord from the equipment and/or system and operate the equipment and/or system by battery power, or use an uninterruptible power supply. 6. Use with other equipment: When the equipment and/or system is adjacent to or stacked with other equipment, the equipment and/or system may affect the other equipment. Before use, check that the equipment and/or system operates normally with the other equipment. 7. Use of unspecified accessory, transducer and/or cable: When an unspecified accessory, transducer and/or cable is connected to this equipment and/or system, it may cause increased electromagnetic emission or decreased electromagnetic immunity. The specified configuration of this equipment and/or system complies with the electromagnetic requirements with the specified configuration. Only use this equipment and/or system with the specified configuration. 8. Use of unspecified configuration: When the equipment and/or system is used with the unspecified system configuration different than the configuration of EMC testing, it may cause increased electromagnetic emission or decreased electromagnetic immunity. Only use this equipment and/or system with the specified configuration. 9. Measurement with excessive sensitivity: The equipment and/or system is designed to measure bioelectrical signals with a specified sensitivity. If the equipment and/or system is used with excessive sensitivity, artifact may appear by electromagnetic interference and this may cause mis-diagnosis. When unexpected artifact appears, inspect the surrounding electromagnetic conditions and remove this artifact source. If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden representative for additional suggestions. The CE mark is a protected conformity mark of the European Community. Products with the CE mark comply with the requirements of the Medical Device Directive 93/42/EEC. BSM-3000 complies with International Standard IEC 60601-1-2: 2001 and Amendment 1: 2004 which requires CISPR11, Group 1, Class A. Class A EQUIPMENT is equipment suitable for use in industrial or light industrial establishments and commercial environment.

Other Caution United States law restricts this product to sale by or on the order of a physician.

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5

Responsibility of the Manufacturer 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 user’s guide, operator’s and service manuals. 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.

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.

Text Conventions • Names of hard keys on the bedside monitor are enclosed in square brackets: [Menu] • Messages that are displayed on the screen are enclosed in quotation marks: “CHECK ELECTRODES” • Names of items that are displayed on the screen are enclosed in angle brackets: <SENSITIVITY>

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Operator’s Manual BSM-3000

Explanations of the Symbols in this Manual and Instrument On Panel Symbol

Description

Symbol

Description

“On” only for a part of instrument

Network socket

“Off” only for a part of instrument

Output terminal

Alternating current

Equipotential terminal

Battery charging

Attention, consult operator’s manual

Out of paper

Serial number

Record

Date of manufacture

Alarm silence

BIS READY label (QE-910P BIS processor/BISx processor can be connected)

ZS

NIBP

ZS socket

NIBP interval

cCSAus mark*

NIBP start

MR unsafe*

NIBP stop

Defibrillation-proof Type CF applied part

Menu

Data input/output

Home

SD card slot

The CE mark** is a protected conformity mark of the European Community. Products marked with this symbol comply with the requirements of the Medical Device Directive 93/42/EEC.

Products marked with this symbol** comply with the European WEEE directive 2002/96/ EC and require separate waste collection. For Nihon Kohden products marked with this symbol, contact your Nihon Kohden representative for disposal.

* Only apply to the Op No. 32A, 52A, 72A, 33A, 53A and 73A. ** Only apply to the Op No. 32K, 52K, 62K, 72K, 33K, 53K, 63K and 73K.

QI-372P Interface Symbol

Description

Symbol

Description

Input/output terminal (Multi-link socket)

External display (RGB socket)

Output terminal (ECG/BP OUT socket)

Attention, consult operator’s manual

Operator’s Manual BSM-3000

7

QI-373P Interface Symbol

Description

Symbol

Description

Input/output terminal (Multi-link socket)

Output terminal (Nurse call socket)

Serial interface (RS-232C socket)

Attention, consult operator’s manual

WS-371P Recorder Module Symbol

Description

Symbol

Description The CE mark is a protected conformity mark of the European Community. Products marked with this symbol comply with the requirements of the Medical Device Directive 93/42/EEC.

Attention, consult operator’s manual Serial number Date of manufacture

SB-671P Battery Pack Symbol

Description

Symbol

Recycle mark Products marked with this symbol comply with environmental protection use period of 10 years according to the ST/J11364 “Marking for Control of Pollution Caused by Electronic Information Products” of the People’s Republic of China Electronic Industry Standard.

Description The CE mark is a protected conformity mark of the European Community. Products marked with this symbol comply with the requirements of the Medical Device Directive 93/42/EEC. Products marked with this symbol require separate waste collection according to EU battery directive 2006/66/EC.

On Screen Symbol

Description

Symbol

Description

Alarm silence

Accessing to SD card

Alarm suspended

Checking SD card

All alarms off/Vital sign alarm limit off

SD card failure

Non-paced

Adjust setting/Scroll data

QRS/pulse sync mark

Zoom in/Zoom out

Respiration sync mark

Left end/Right end

Battery status

@

Touch panel calibration

Cascade display

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Operator’s Manual BSM-3000

General Safety Information WARNING

WARNING

Never use the monitor in the presence of any flammable anesthetic gas or high concentration oxygen atmosphere. Failure to follow this warning may cause explosion or fire.

Never use the monitor in a hyperbaric oxygen chamber. Failure to follow this warning may cause explosion or fire.

WARNING

WARNING

When the monitor is used with an electrosurgical unit (ESU), firmly attach the entire area of the ESU return plate. Otherwise, the current from the ESU flows into the electrodes of the monitor, causing electrical burn where the electrodes are attached. For details, refer to the ESU manual.

When performing defibrillation, discharge as far as possible from electrodes, patches and any gel, cream or medicine on the chest of the patient. If there is a possibility that the defibrillator paddle could touch these materials, remove them from the patient. If the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient.

WARNING

WARNING

Before defibrillation, all persons must keep clear of the bed and must not touch the patient or any equipment or cord connected to the patient. Failure to follow this warning may cause electrical shock or injury.

Do not perform defibrillation when the cables are located between the defibrillator paddles. The discharged energy may be insufficient.

WARNING

WARNING

When performing MRI test, remove all electrodes and transducers from the patient which are connected to this instrument. Failure to follow this warning may cause skin burn on the patient. For details, refer to the MRI manual.

Do not allow the conductive part of the connector which is connected to the patient to contact other conductive parts including earth. This causes leakage current and incorrect measurement value and leads to wrong diagnosis.

WARNING

WARNING

After attaching electrodes, probes and sensors on the patient and connecting cables to the bedside monitor, check that there is no error messages and the waveforms and numeric data are appropriately displayed on the screen. If there is an error message, or waveform or numeric data is not appropriate, check the electrodes, probes and sensor attachment, patient condition and settings on the bedside monitor and remove the cause.

Do not use the same monitor for more than one patient at the same time. Do not connect different sensors from different patients to the same monitor.

Operator’s Manual BSM-3000

WARNING Do not leave the SD card near the patient or in reach of children.

9

CAUTION Only use Nihon Kohden specified electrodes, probes, transducers, thermistors and catheters. Otherwise, the maximum performance from the monitor cannot be guaranteed.

CAUTION Do not reuse disposable parts and accessories. For caution and usage of the electrode and transducer, refer to the manual of the electrode and transducer.

CAUTION

CAUTION

Make sure that the electrodes and cords attached to the patient are properly connected to the monitor. Otherwise, incorrect data may be displayed and lead to wrong diagnosis.

After the monitor power is turned on, parameterrelated alarms do not function until the parameters are monitored.

CAUTION

CAUTION

Turn off the power of mobile phones, small wireless devices and other devices which produce strong electromagnetic interference around a patient (except for devices allowed by the hospital administrator). Radio waves from devices such as mobile phones or small wireless devices may be mistaken as pulse waves and the displayed data may be incorrect.

When admitting a new patient, first delete all data of the previous patient. Otherwise, the data of the previous patient and new patient will be mixed together.

CAUTION

CAUTION

When the “CONNECTOR OFF” message appears on the screen, check that the connection cords are connected to the sockets properly. The patient cannot be monitored and the alarm does not function while this message is displayed.

If fluids are accidentally spilled into the monitor, take the monitor out of service and contact your Nihon Kohden representative. The monitor must be disassembled, cleaned, dried and tested for safety and function.

CAUTION

CAUTION

The ZS-900P transmitter can only transmit temperature data from 5 to 45°C (41 to 113°F). Be careful when reading the value.

When using a ZS-900P transmitter, the measurement values and displayed waveform on the bedside monitor and receiving monitor may differ due to timing delay of the display and other factors. Be careful when reading the value and waveform.

CAUTION When transmitting CO2 data through a ZS-900P transmitter to a receiving monitor, if the transmitted CO2 data is out of the range of the receiving monitor, the maximum value of the receiving monitor is displayed instead. Be careful when reading the value. NOTE: Operate the monitor on battery power if you cannot confirm the grounding or wiring in your facility. 10

Operator’s Manual BSM-3000

Using External Instruments

WARNING When connecting an external instrument using an interface or communication cable to the monitor, some alarms and messages from the external instrument might not be displayed on the monitor. When the waveform or data is abnormal, check the alarm and message on the external instrument.

Operator’s Manual BSM-3000

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Panel Description BSM-3532/BSM-3552/BSM-3562/BSM-3572 Bedside Monitor Front Panel Alarm indicator Red or yellow lamp blinks, or yellow or cyan lamps lights according to the alarm settings. Green lamp blinks in synchronization with the patient’s QRS or pulse.

Silence Alarms key Silences the alarm sound. NIBP interval key Selects NIBP measurement mode. Pressing this key changes the mode. NIBP Start/Stop key Starts NIBP measurement in selected mode. Pressing the key during measurement stops measurement.

Touch screen Displays monitoring data. Touching a key or data on the screen changes the displayed screen and settings.

Menu key Displays the MENU window.

Power switch Press to turn the monitor power on. When turning the monitor power off, press and hold for more than three seconds.

AC power lamp Lights when the power cord is connected between the AC SOURCE socket and AC outlet.

Home key Closes all opened windows and displays the home screen.

Battery lamp Indicates a status of the battery in the battery slot.

Remote control sensor Receives an infrared signal from the remote control.

Error lamp (option) Blinks when out of paper. Lights when the recorder door is open. Record/Stop key (option) Press to start or stop recording. Speaker For alarm and sync sound.

Left Side Panel

TEMP socket Connects to the temperature probe cord.

MULTI socket Connects to the connection cord of the parameter to be monitored (IBP, CO, CO2, BIS or CCO (APCO)). The type of parameter is automatically recognized.

SpO2 socket Connects to the SpO2 connection cord.

ECG/RESP socket Connects to the ECG connection cord.

NIBP socket Connects to the air hose.

WARNING When performing defibrillation during cardiac output monitoring, never touch the CO connection cord. The discharged energy may cause electrical shock or injury.

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Operator’s Manual BSM-3000

Right Side Panel When the WS-371P recorder module and QI-372P interface are installed SD card slot For the SD card or program card.

ZS socket For the ZS-900P* transmitter. * ZS-900P transmitter is not available in USA. Network socket Connects to monitor network system via the network separation unit.

Recorder module holder For the WS-371P recorder module.

Multi-link socket (QI-372P) Connects a QF series interface, IF series communication cable or multi-link cable of an external unit. RGB socket (QI-372P) Outputs the RGB video signal. Connects to the slave display. ECG/BP OUT socket (QI-372P) Outputs 100 mmHg/V IBP waveform and 1 mV/V ECG waveform and heart rate trigger by using the YJ-910P or YJ-920P ECG/BP output cable. These analog signals can be used as the synchronization signal for other equipment, such as IABP.

When the WS-371P recorder module and QI-373P interface are installed

Multi-link socket (QI-373P) Connects a QF series interface, IF series communication cable or multi-link cable of an external unit. Nurse call socket (QI-373P) Connects a YJ-672P nurse call cable. RS-232C socket (QI-373P) Not available.

CAUTION

CAUTION

When using the output signal from the monitor as the synchronization signal for other equipment such as an IABP (intra-aortic balloon pump) or defibrillator: • Set the timing of the IABP by checking the waveform on the IABP screen. • Check the condition of the bedside monitor at all times. The output signal may become unstable. • Check that the delay time of the output signal is within the range of the connected equipment.

Only a Nihon Kohden defibrillator can use the output signal from the monitor as a synchronization signal. Check that the delay time of the output signal (heart rate trigger 20 ms maximum) is within the range of the connected defibrillator.

Operator’s Manual BSM-3000

13

NOTE: • When using an IBP waveform as a synchronization signal for other equipment, connect the IBP line to the MULTI socket on the monitor. The IBP waveform that is used for the synchronization signal depends on the “IBP ANALOG OUT” setting in the SYSTEM SETUP window. - When “IBP ANALOG OUT” is set to “FIXED POSITION”: The IBP line connected to the top MULTI socket on the monitor is used. - When “IBP ANALOG OUT” is set to “HIGHEST PRIORITY LABEL” : When more than one IBP waveform is acquired, the IBP waveform of the highest priority label is used. IBP label priority: ART > ART2 > RAD > DORS > AO > FEM > UA > LVP > P1 > P2 > P3* * P3 label is not available when a BSM-3532, BSM-3552, BSM-3562 or BSM-3572 bedside monitor is used. • The output signal from the ECG/BP OUT socket may become unstable in the following conditions. - Electrode is dry or detached. - Electrode lead is damaged or disconnected from the electrode. - Electrode lead is pulled. - AC interference or EMG noise superimposed. - Air bubbles or blood clog in the circuit for monitoring IBP. - Cord or cable is disconnected or damaged. • All instruments which are to be connected to the ECG/BP OUTPUT socket must use a YJ-910P or YJ-920P ECG/BP output cable and comply with the IEC 60601-1 safety standard for medical equipment.

Rear Panel

AC SOURCE power cord socket For the AC power cord.

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Equipotential grounding terminal For an equipotential grounding lead.

Battery pack holder For an SB-671P battery pack.

Operator’s Manual BSM-3000