Life ScopeTR BSM-6000 series Operators Manual Sixteenth Edition April 2014

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... 6 Responsibility of the Manufacturer... 6 Conventions Used in this Manual and Instrument... 7 Warnings, Cautions and Notes... 7 Text Conventions... 7 Explanations of the Symbols in this Manual and Instrument... 8 General Safety Information... 11 Panel Description... 14 MU-631R Main Unit... 14 MU-651R/MU-671R Main Unit... 16 AY-631P/AY-633P/AY-651P/AY-653P/AY-660P/ AY-661P/AY-663P/AY-671P/AY-673P Input Unit... 18 BSM-1700 series Bedside Monitor... 20 AA-672P/AA-674P Smart Expansion Unit... 21 Installation... 22 General... 22 Grounding the Monitor... 23 Environment for External Instruments... 23 Warnings and Cautions for Connecting the Monitor to a Network... 24 Inserting and Removing the Battery Packs... 25 Inserting the Battery Pack... 25 Removing the Battery Pack... 26 Inserting and Removing the AY-600P series Input Unit or BSM-1700 series Bedside Monitor.. 27 Inserting the Input Unit... 27 Removing the Input Unit... 27 Loading Recording Paper... 28 Turning the Monitor On or Off... 29 Turning the Monitor On... 29 Check Before Turning On the Power... 29 Check After Turning On the Power and During Monitoring... 30 Power and Battery Status Indications... 31 Battery Pack Handling and Operation... 32 Charging the Battery Pack... 34 Stored Data Status at Power On... 34 Monitor Status on Power Interruption... 35 Turning the Monitor Off... 35 Operator’s Manual BSM-6000

Check After or Before Turning the Power Off... 35 Basic Operation... 36 Using the Hard Keys on the Bedside Monitor and Touch Screen... 36 Using the Remote Control... 36 Using the Mouse... 36 Home Screen Description... 37 Settings for the Home Screen... 38 Trendgraph on the Home Screen (Current Trendgraph)... 39 OCRG... 39 Freezing Waveforms... 39 Using the Timer... 39 Car Seat Challenge... 39 Using Sleep Mode... 40 MENU Window Description... 41 Changing Settings... 42 Administrator Settings... 42 Changing Parameter Settings and Other Settings... 42 Changing Settings... 42 Changing Settings on the VOLUME Window.. 43 Admitting/Discharging Patient... 44 Admitting a Patient... 44 Discharging a Patient... 46 Stored Data Status and Screen Transition for Admitting Patient... 46 Using Transport Function... 49 Input Unit... 49 Transport Function... 49 Warnings and Cautions for Transport... 49 Alarms... 52 Alarm Types and Levels... 52 Alarm Control Marks... 53 Flow of Alarm Function... 54 Silencing/Suspending Alarms... 55 Silencing Alarms... 55 Suspending Alarms... 55 Canceling Technical Alarms... 58 Alarm Sound Volume... 58 Alarm Recording... 58 Alarm Setting... 58 Changing Vital Sign Upper/Lower Alarm Limits... 60 Changing the Arrhythmia Alarm Settings... 63 Alarm Escalation... 64 C.1

Interbed Alarm... 65 Review Windows... 66 General... 66 Event Bar... 67 TREND Window... 68 GRAPH 1, GRAPH 2, GRAPH 3 Page... 68 TABLE 1, TABLE 2, TABLE 3 Page... 69 NIBP TREND Page... 70 HEMO TREND Page... 71 Registering the Acquired Data to the Hemodynamics Table... 71 LUNG TREND Page... 72 RECALL Window... 73 ARRHYTH HISTORY Page... 73 ALARM HISTORY Window... 74 ALARM HISTORY Page... 74 FULL DISC Window... 75 FULL DISC Page... 75 ST Window... 77 ST INTERVAL Page... 77 OCRG Window... 78 aEEG Window... 79 12 LEAD/12 LEAD ANALYSIS Windows... 80 General... 80 12 LEAD ANALYSIS Window... 81 Performing 12 Lead ECG Interpretation... 81 12 LEAD Window... 83 Viewing the 12 Lead Analysis Result... 83 DRUG/LUNG FUNCTION Windows... 85 DRUG Window... 85 LUNG FUNCTION Window... 87 Recording... 89 Recording Modes... 89 When More than One Recording Modes is Triggered... 89 Changing Recording Settings... 89 Selecting Recording Waveforms... 90 Changing Recording Speed... 90 Selecting Recording Interval for Periodic Recording... 90 Turning Alarm Recording On or Off... 90 INTERBED Window... 91 Registering/Removing Interbed Beds... 91 Displaying the Interbed Bed Data... 92 Interbed Alarm Function... 94 Interbed Alarm Setting... 94 Monitoring Parameters... 95 ECG... 95 Preparation... 95

C.2

Monitoring Arrhythmia... 98 Changing ECG Settings... 101 Respiration... 108 Preparation... 108 Changing Respiration Settings... 109 CO2 . ... 111 Preparation... 112 Changing CO2 Settings... 115 Inspection of Measuring Accuracy... 118 Use with Volatile Anesthetic Agents... 118 SpO2 with Nihon Kohden Probes (AY-660P/ AY-661P/AY-663P/AY-671P/AY-673P/BSM-1763/ BSM-1773)... 119 Silencing SpO2 Alarm... 120 Preparation... 120 Changing SpO2 Settings... 122 SpO2 with Nellcor Probes (AY-651P/AY-653P/ BSM-1753)... 127 Silencing SpO2 Alarm... 128 Preparation... 128 Changing SpO2 Settings... 130 SpO2 with Masimo Probes (AY-631P/AY-633P/ BSM-1733)... 133 Silencing SpO2 Alarm... 134 Preparation... 134 Changing SpO2 Settings... 138 NIBP... 142 Preparation... 142 Changing NIBP Settings... 144 Starting and Stopping NIBP Measurement... 146 IBP... 151 Preparation... 151 Connecting Cables to the Unit... 151 Assembling the Transducer... 152 Adjusting Zero Balance... 153 The CHECK ZERO Page... 154 Changing IBP Settings... 154 Temperature... 159 Preparation... 159 Using the Insulation Pad... 160 Changing Temperature Settings... 160 BIS... 162 Preparation... 162 Changing the BIS Settings... 166 Cardiac Output... 169 Preparation... 169 Measuring the Pulmonary Capillary Wedge Pressure... 170 Measuring Cardiac Output... 171

Operator’s Manual BSM-6000

Deleting the Data from the CO Table... 174 Adding the Acquired Data to the HEMO TREND Page of the TREND Window... 175 GAS... 176 Preparation... 176 Changing Gas Settings... 176 Inspection of Measuring Accuracy... 179 O2 ... 180 Preparation... 180 Changing O2 Settings... 181 CCO... 182 Preparation... 182 Changing the CCO Settings... 183 Other Parameters... 185 Screen Messages... 187 Troubleshooting... 206 Monitoring... 206 Network... 207 Transport... 207 Remote Control... 208 Recording... 208 Printing... 209 ECG... 209 Respiration... 210 Impedance Method... 210 Thermistor Method... 210 CO2 . ... 211 Mainstream Method... 211 Sidestream Method... 212 When Using Microcap® Monitor... 212 SpO2 ... 213 When Using Nellcor/Masimo Pulse Oximeter... 213 NIBP... 214 Temperature... 214 BIS... 215 When Using BIS Processor/BISx... 215 When Using BIS Monitor... 215 IBP... 215 Cardiac Output... 216 GAS... 216 When Using AG-920R Multigas Unit... 216 When Using GF-110PA Multigas Unit or GF-120PA Multigas/Flow Unit... 216 When Using GF-210R Multigas Unit or GF-220R Multigas/Flow Unit... 217 O2 ... 218 Ventilation... 219 TOF... 219

Operator’s Manual BSM-6000

CCO... 219 When Using APCO/IBP Processor... 219 When Using PiCCO Monitor... 220 When Using Other CCO Monitors... 220 FLOW/Paw... 221 When Using GF-120PA Multigas/Flow Unit... 221 When Using GF-220R Multigas/Flow Unit... 221 EEG... 222 tcPO2/tcPCO2 ... 222 rSO2 . ... 223 Anesthesia... 223 Transmitter... 223 12 Lead ECG... 223 aEEG... 223 Maintenance... 224 MU-631R, MU-651R and MU-671R Main Unit... 224 Cleaning and Disinfecting the Main Unit... 224 Cleaning the Touch Screen... 225 Disposing of the Main Unit... 226 WS-671P Recorder Module... 226 Cleaning the Thermal Head... 226 Cleaning the Sensors... 226 Disposing of the Recorder Module... 226 AY Series Input Unit and AA-672P/AA-674P Smart Expansion Unit... 227 Cleaning and Disinfecting the Units... 227 Disposing of the Units... 227 BSM-1700 series Bedside Monitor... 227 SB-671P Battery Pack... 227 Battery Lifetime... 227 Replacing the Batteries... 227 Disposing of Batteries... 227 RY-910P Remote Controller... 227 Cleaning and Disinfecting the Remote Controller... 227 Disposing of the Remote Controller... 227 Replacing the Batteries... 227 Disposing of Batteries... 227 QF series Interface and IF series Communication Cable... 227 Cleaning and Disinfecting the Interface and Communication Cable... 227 Disposing of the Interface and Communication Cable... 228 Leads, Cables and Cords... 228 Cleaning the Leads, Cables and Cords... 228 Disinfecting the Leads, Cables and Cords... 228 Disposing of Leads, Cables and Cords... 228

C.3

Electrodes, Probes, Cuffs, Thermistors, Transducers, Catheters and Other Consumables... 228 Yearly Inspection... 228 Safety Information for Maintenance on Optional Units... 229 AG-920R, GF-110PA or GF-210R Multigas Unit and GF-120PA or GF-220R Multigas/ Flow Unit... 229 AG-400R CO2 Unit... 230 AE-918P Neuro Unit... 230 Specifications... 231 Measuring Parameters... 231 Influence on Measuring Accuracy by Electrosurgery/Defibrillation/Electrostatic Discharge... 231 Display... 231 Alarm... 232 Alarm Delay Time... 233 ECG... 234 Respiration (Transthoracic impedance pneumography)... 236 SpO2 ... 236 Non Invasive Blood Pressure, NIBP... 239 Multi Socket... 240 Invasive Blood Pressure, IBP... 240 Temperature... 241 Carbon Dioxide, CO2 (Mainstream method)... 241 Inspired Oxygen Fractional Concentration, O2 .. 242 Cardiac Output, CO... 242 Respiration (Thermistor method)... 243 Bispectral Index, BIS... 243 ECG/BP Output... 244 RGB Socket (when QI-631P or QI-671P is connected)... 244 RS-232C Socket (when QI-631P or QI-671P is connected)... 245 Alarm Socket (when QI-632P or QI-671P is connected)... 245 When WS-671P Recorder Module is Connected... 245 When ZS-900P Transmitter is Connected... 245 Gas... 245 Carbon Dioxide, CO2 (Sidestream method)... 248 FLOW/Paw... 249 EEG... 249 CCO... 250 Battery (SB-671P Battery Pack)... 250 Power Requirement... 251

C.4

Clock Accuracy... 251 Environment... 251 Mechanical Strength... 251 Electromagnetic Compatibility... 251 Safety Standard... 252 Dimensions and Weight (approximate)... 253 Electromagnetic Emissions... 254 Electromagnetic Immunity... 255 Recommended Separation Distances between Portable and Mobile RF Communications Equipment... 257 System Composition for EMC Test... 258 Factory Default Settings... 259 Event Bar... 259 TREND Window... 260 RECALL Window... 263 FULL DISC Window... 263 ST Window... 263 OCRG Window... 264 aEEG Window... 264 ADMIT DISCHARGE Window... 264 ALARM LIMITS Window... 265 Vital Signs Alarms... 265 Arrhythmia Alarms... 270 DATE Window... 271 VOLUME Window... 271 DISPLAY Window... 271 RECORD Window... 271 ECG Window... 272 RESP/CO2 Window... 273 SpO2 Window... 273 NIBP Window... 274 PRESS Window... 275 TEMP Window... 276 BIS Window... 276 CO Window... 276 GAS Window... 277 O2 Window... 278 VENT Window... 278 CCO Window... 278 FLOW/Paw Window... 279 EEG Window... 280 ANALOG Window... 281 rSO2 Window... 281 12 LEAD ANALYSIS Window... 281 DRUG Window... 282 LUNG FUNCTION Window... 284 INTERBED Window... 284 CAR SEAT CHALLENGE Window... 284 Standard Accessories... 285 Operator’s Manual BSM-6000

MU-631RA/MU-651RA/MU-671RA Main Unit... 285 MU-631RK/MU-651RK/MU-671RK Main Unit... 285 Options/Consumables... 286 Accessory Set... 286 MU-631RA/MU-651RA/MU-671RA Main Unit... 286 MU-631RK/MU-651RK/MU-671RK Main Unit... 287 Units and Modules... 288 Network... 288 Interfaces for Connecting External Instruments... 289 Cart and Attaching Parts... 290 For ECG and Respiration (Impedance Method) Monitoring... 291 For Respiration Monitoring (Thermistor Method)... 291 For CO2 Monitoring (Mainstream Method)... 292 For SpO2 Monitoring... 293 For NIBP Monitoring... 294 For IBP Monitoring... 295 For Temperature Monitoring... 296 For BIS Monitoring (Using the BIS Processor/ BISx)... 296 For CO Monitoring... 296 For O2 Monitoring... 297 For CCO Monitoring... 297 For CO2 Sidestream Monitoring... 297 For BIS Monitoring (Using the BIS Monitor)... 297 For Anesthetic Agent Monitoring... 297 For FLOW/Paw Monitoring... 297 For EEG Monitoring... 297 General Requirements for Connecting Medical Electrical Systems... 298

Operator’s Manual BSM-6000

C.5

About this Manual This Operator’s Manual describes the most common features and functions of the BSM-6301A/K, BSM-6501A/K and BSM-6701A/K bedside monitors.

Related Documentation The BSM-6301A/K, BSM-6501A/K and BSM-6701A/K 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-6000

1

Intended Purpose The Life Scope TR BSM-6301A/K, BSM-6501A/K and BSM-6701A/K bedside monitors are for one patient. The BSM-6301A/K bedside monitors have a 10.4 inch TFT color display, BSM-6501A/K have a 12.1 inch TFT color display, and BSM-6701A/K 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. With the basic configuration of the system, ECG, respiration in impedance or thermistor method, SpO2, NIBP, IBP, temperature, CO2 and O2 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. The basic configuration of the system is the following units. This manual is based on this configuration. * 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.

• MU-631RA/RK, MU-651RA/RK, MU-671RA/RK main unit • QI-631P, QI-632P, QI-634P, QI-671P, QI-672P interface • AY series input unit or BSM-1700 series 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 Dual SpO2 NIBP PWTT measurement Smart expansion unit Analog ECG Analog BP HT output

AY631P

AY633P

AY651P

AY653P

AY660P*1

1

3

1

3

1

RESP (Thermistor), CO2, SpO2, IBP, TEMP, BIS, CO, O2, CCO (APCO)

AYAY661P*1 663P*1 AY-671P AY-673P 1

BSM1733

BSM1753

3

RESP (Thermistor), CO2, SpO2, IBP, CO2, IBP TEMP, BIS, CO, O2, CCO (APCO)

3 ECG, respiration in impedance method, SpO2, NIBP, temperature (up to 2 channels), IBP (up to 3 channels), ETCO2, FiCO2, cardiac output, SpO2-2, BIS

2

1

2

2

Yes

No

Yes

Yes

Yes

No

Yes Nihon Kohden*2 5 Yes* Yes*6

Yes

Masimo Yes*3

Nellcor Yes*4 No

Yes

Masimo Yes*3

Nellcor Yes*4

Nihon Kohden Yes*6

No

Yes No

Yes

No

Yes

Yes Yes Yes

*1 These are not available for BSM-6000A series. *2 When the probe is not connected to the SpO2 socket, Masimo or Nellcor probe can be used with IF-925P or IF-919P communication cable. *3 IF-925P communication cable is required. *4 IF-919P communication cable is required. *5 Dual SpO2 is available when the MULTI socket on the JA-694PA data acquisition unit is used. *6 JL-500P1 or JL-500P2 SpO2 adapter is required.

2

BSM1773

BSM1763*1

Operator’s Manual BSM-6000

• AA-672P/AA-674P smart expansion unit • WS-671P recorder module • SB-671P battery pack For simplicity, the model number suffix A/G/K is omitted in this manual. NOTE: • This monitor must be used by qualified medical personnel with a full knowledge of operating this monitor. • Upgrade the main unit and each optional unit to the Nihon Kohden recommended software version. Only use the specified configuration of units. If more than one BSM-6000 series bedside monitor is used in the same facility, make sure the bedside monitors have the same software version. If BSM-6000 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. - BSM-9101A software version 13-03 or later - BSM-6000A series software version 04-01 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-6000 series Administrator’s Guide. • Only use Nihon Kohden parts and accessories to assure maximum performance from your instrument.

Operator’s Manual BSM-6000

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, input units 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.

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. 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 4

Operator’s Manual BSM-6000

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-6301 and BSM-6501 (JA-690PA or JA-694PA data acquisition unit, QE-910P BIS processor, AE-918P neuro unit, JP-911P IBP interface isolation cable and QI-320PA or QI-420PA wireless LAN station are not connected) comply with International Standard IEC 60601-1-2: 2001 and Amendment 1: 2004 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. BSM-6301, BSM-6501 (JA-690PA or JA-694PA data acquisition unit, QE-910P BIS processor, AE-918P neuro unit, JP-911P IBP interface isolation cable or QI-320PA or QI-420PA wireless LAN station is connected) and BSM-6701 comply 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. Operator’s Manual BSM-6000

5

BSM-6301 and BSM-6501 (when QE-910P and ZS-900P are connected) are CLASS A equipment if the equipment complies with IEC 60601-1-2: 2001 36 201.1.5 in the countries which do not have national wireless rule.

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

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.

6

Operator’s Manual BSM-6000

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>

Operator’s Manual BSM-6000

7

Explanations of the Symbols in this Manual and Instrument MU-631R/MU-651R/MU-671R Main Unit 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)

NIBP

Battery slot 1/Battery slot 2 (MU-631R only)

ZS

NIBP interval

ZS socket

NIBP start

CSA mark*

NIBP stop

MR unsafe*

Menu

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.

Home Data input/output SD card slot

* The CSA mark and MR unsafe mark only apply to the MU-631RA/MU-651RA/MU-671RA. ** The CE mark and WEEE mark only apply to the MU-631RK/MU-651RK/MU-671RK.

AY Series Input Unit Symbol

Description

Symbol

Defibrillation-proof type CF applied part Output terminal Date of manufacture Attention, consult operator’s manual

Description Serial number 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.

BSM-1700 Series Bedside Monitor Refer to the BSM-1700 series bedside monitor operator’s manual. 8

Operator’s Manual BSM-6000

AA-672P/AA-674P Smart Expansion Unit Symbol

Description

Symbol

Defibrillation-proof type CF applied part

Description Date of manufacture 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

QI-631P Interface Symbol

Description

Symbol

Serial interface (RS-232C socket)

Description Attention, consult operator’s manual

External display (RGB socket)

QI-632P Interface Symbol

Description Input/output terminal (USB socket and Multi-link socket)

Symbol

Description Attention, consult operator’s manual

Output terminal (Alarm socket)

QI-634P Interface Symbol

Description Input/output terminal (USB socket and Multi-link socket)

Symbol

Description Attention, consult operator’s manual

QI-671P Interface Symbol

Description

Symbol

Description

Input/output terminal (Multi-link socket)

External display (RGB socket)

Serial interface (RS-232C socket)

Attention, consult operator’s manual

Output terminal (Alarm socket)

QI-672P Interface Symbol

Description Input/output terminal (USB socket and Multi-link socket)

Operator’s Manual BSM-6000

Symbol

Description Attention, consult operator’s manual

9

WS-671P 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

Description Products marked with this symbol require separate waste collection according to EU battery directive 2006/66/EC. 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.

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.

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

10

Operator’s Manual BSM-6000

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 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.

WARNING 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.

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.

Operator’s Manual BSM-6000

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 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.

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

11

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

CAUTION

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

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

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 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.

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.

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.

CAUTION 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 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.

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Operator’s Manual BSM-6000

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-6000

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