Vismo PVM-2700 series Users Guide 8th Edition March 2018

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

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GENERAL HANDLING PRECAUTIONS... i WARRANTY POLICY... ii EMC RELATED CAUTION...iii Conventions Used in this Manual and Instrument... v Warnings, Cautions and Notes... v Text Conventions in this Manual... v Explanations of the Symbols in this Manual and Instrument ... vi Related Documentation... ix Safety Standards... ix Safety Information... ix Periodic Inspection... x

3 4 5 6 7 8 9

Section 1

General... 1.1 Introduction... 1.2 Features... 1.3 Composition... 1.4 Panel Description... 1.5 Front Panel... 1.5 Left Side Panel... 1.5 Right Side Panel... 1.6 Rear Panel... 1.6 Basic Operating Concepts... 1.7 Screen Displays... 1.7 Using Touch Screen Keys... 1.12 Keys on the Bedside Monitor... 1.13 Using MENU Window... 1.13 Guide Window... 1.14

Section 2

Preparation... 2.1 Preparation Flowchart... 2.2 Installation Conditions... 2.3 Inserting and Removing the Battery Pack... 2.5 Battery Pack Handling and Operation... 2.5 Safety Information... 2.5 Battery Pack Handling Precautions... 2.6 When Not Using the Monitor or Battery Pack... 2.6 Inserting and Removing the Battery Pack... 2.7 Inserting the Battery Pack... 2.7 Removing the Battery Pack... 2.9 Preparing the Optional Recorder Module... 2.10 Installing the Recorder Module... 2.10 Loading Recording Paper... 2.10 Attaching the Transmitter... 2.12

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CONTENTS Using the Hospital ID Function... 2.13 Power... 2.14 Connecting the Power Cord and Grounding the Monitor... 2.14 Connecting the Power Cord... 2.14 Grounding the Monitor... 2.15 Turning the Monitor Power On... 2.15 Check Before Turning On the Power... 2.15 Turning the Power On... 2.16 Check After Turning On the Power and During Monitoring... 2.17 Power and Battery Status Indications... 2.18 When the “BATTERY WEAK” Message Appears... 2.19 Charging the Battery Pack... 2.19 Monitor Status on Power Interruption... 2.20 Turning the Monitor Power Off... 2.20 Check After/Before Turning the Power Off... 2.20

Section 3

Necessary Settings Before Monitoring... 3.1 Changing Date and Time... 3.2 Changing Sound Volume Settings... 3.3 Changing the Screen Brightness... 3.5 Changing Waveform Sweep Speed... 3.6 Admitting/Discharging a Patient... 3.7 Displaying the ADMIT DISCHARGE Window... 3.8 Entering the Patient ID... 3.9 Entering the Patient Name... 3.10 Entering the Patient Name Using the Keyboard... 3.10 Entering the Patient Name Using Free Function... 3.11 Selecting Patient Type... 3.12 Importing Patient Information from the Hospital Network... 3.13 Admitting a Patient... 3.14 Discharging a Patient... 3.15 Suspended Alarms after Admission or Discharge... 3.16

Section 4

Home Screen... 4.1 Safety Precautions for Monitoring... 4.3 Using an Electrosurgical Unit... 4.3 Using a Defibrillator... 4.3 Overview... 4.4 Home Screen... 4.4 Review Windows... 4.4 Sync Sound... 4.4 Adjusting the Sync and Alarm Sound Volume... 4.4 Changing Settings and Performing Other Tasks During Monitoring... 4.5 Recording on the Home Screen... 4.5 Home Screen... 4.6 Settings for the Home Screen... 4.7 Waveform Sweep Speed... 4.7

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CONTENTS Parameter Colors... 4.7 Waveform Sensitivity... 4.8 Numeric Parameter Display Area (On the DISPLAY window of the SYSTEM SETUP window)... 4.8 Displaying Other Windows from the Home Screen... 4.9 Freezing Waveforms... 4.10 Using Sleep Mode... 4.11 Turning Sleep Mode On... 4.12 Turning Sleep Mode Off... 4.12 Displaying the LARGE NUMERICS Screen... 4.13

Section 5

Alarm Function... 5.1 Overview of Alarms... 5.3 What is an Alarm... 5.3 Alarm Level... 5.4 Alarm Priority... 5.4 Deactivating Alarms... 5.4 Termination of Alarm... 5.4 Reactivation of Alarm... 5.5 Alarm Activation after Power On... 5.5 Alarm Master... 5.5 Automatic Recording... 5.6 Alarm Setting... 5.6 Adjusting Alarm Sound Volume... 5.6 ALARM HISTORY Window... 5.6 Alarm Escalation... 5.6 Alarm Types... 5.7 Upper/Lower Limit Alarms... 5.7 Arrhythmia Alarms... 5.7 Technical Alarms... 5.8 ECG Related Alarms... 5.8 CO2 Related Alarms (PVM-2703 only)... 5.9 SpO2 Related Alarms... 5.9 NIBP Related Alarms... 5.9 IBP Related Alarms (PVM-2703 only)... 5.10 Temperature Related Alarms... 5.10 Other Alarms... 5.10 Interbed Alarms... 5.11 Messages... 5.11 ECG Related Messages... 5.11 Respiration Related Messages... 5.11 CO2 Related Messages (PVM-2703 only)... 5.12 SpO2 Related Messages... 5.12 NIBP Related Messages... 5.12 IBP Related Message (PVM-2703 only)... 5.13 Other Messages... 5.13 Alarm Indications... 5.14 Overview... 5.14

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CONTENTS Individual Alarm Indications... 5.14 Upper/Lower Limit Alarms... 5.15 Arrhythmia Alarms... 5.17 Technical Alarms... 5.18 Alarm Condition Marks... 5.22 Individual Upper/Lower Limit Alarm Off Marks... 5.22 Flow of Alarm Function... 5.23 Deactivating Alarms... 5.24 Overview... 5.24 Silencing Alarms... 5.24 Resetting Alarms... 5.24 Suspending Alarms... 5.25 Silencing Alarms After Alarm Occurrence... 5.27 Silencing Alarms... 5.27 Canceling Alarm Silence... 5.27 Resetting Alarms After Alarm Occurrence... 5.27 Suspending Alarms Before Alarm Occurrence... 5.28 Suspending Alarms... 5.28 Suspending All Alarms Indefinitely... 5.28 Suspending All Alarms and NIBP STAT and Auto Measurement Indefinitely... 5.30 Turning Automatic Alarm Recording On/Off... 5.31 Setting Alarms... 5.33 Overview... 5.33 Alarm Limits Ranges... 5.33 Upper/Lower Limit Alarms... 5.34 Arrhythmia Alarms... 5.37 Setting Upper/Lower Limit Alarms Individually... 5.38 Automatically Setting All Upper and Lower Alarm Limits (Including ST)... 5.39 Automatic Setting Range... 5.39 Setting All Upper/Lower Limit Alarms to a Preset Pattern (Alarm Master)... 5.40 Checking Arrhythmia Alarm Settings... 5.42 Interbed Alarm... 5.43 Checking the Alarm Function... 5.44

Section 6

Review Windows... 6.1 General... 6.3 Review Recording... 6.3 Time Bar... 6.4 Scrolling the Time Bar... 6.4 TREND TABLE Window... 6.5 Overview... 6.5 Displaying the TREND TABLE Window... 6.5 Scrolling the Trend Table... 6.6 Selecting Parameters for the TREND TABLE Display... 6.6 Selecting the Measurement Interval... 6.7 Recording the Trend Table... 6.8 Printing a Trend Table... 6.9

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CONTENTS NIBP TABLE Window... 6.11 Overview... 6.11 Displaying the NIBP TABLE Window... 6.11 Scrolling the NIBP Trend Table... 6.12 Selecting Parameters for the NIBP Trend Display... 6.12 Recording the NIBP Trend Table... 6.13 Printing a NIBP Table... 6.15 TREND GRAPH Window... 6.16 Overview... 6.16 Displaying the TREND GRAPH Window... 6.17 Selecting Parameters for the Trendgraph Display... 6.18 Changing the Trendgraph Scale... 6.19 Changing the Trendgraph Display Format... 6.20 Recording the Trendgraph... 6.22 Printing the Trendgraph... 6.23 RECALL Window... 6.25 General... 6.25 Arrhythmia List... 6.25 Displaying the RECALL Window... 6.27 Scrolling the Arrhythmia Recall Files... 6.27 Selecting the Arrhythmia Types to be Saved as a Recall File... 6.28 Displaying the Actual Size Waveform of the Selected Arrhythmia Recall File... 6.29 Arrhythmia Waveform Annotation... 6.29 Recording the Arrhythmia Recall Waveform... 6.30 Recording on the ARRHYTH HISTORY Window... 6.30 Printing on the ARRHYTH HISTORY Window... 6.31 Recording on the Actual Size ECG Waveform Window... 6.32 Printing on the Actual Size ECG Waveform Window... 6.33 Full Disclosure Window... 6.34 Displaying the FULL DISC Window... 6.34 Scrolling the Full Disclosure Waveform... 6.37 Recording or Printing the Full Disclosure Waveform... 6.37 Recording the Full Disclosure Waveform... 6.37 Printing the Full Disclosure Waveform... 6.38 Recording or Printing the Enlarged ECG Waveform... 6.39 Recording the Enlarged ECG Waveform... 6.39 Printing the Enlarged ECG Waveform... 6.40 Alarm History Window... 6.41 Displaying the ALARM HISTORY Window... 6.41 Scrolling the Alarm History Files... 6.42 Recording the Alarm History File... 6.42 Recording the Alarm History Files... 6.42 OCRG Window... 6.44 Displaying the OCRG Window... 6.44 Changing the OCRG Display Setting... 6.45 Changing the Trendgraph Scale for Heart Rate and SpO2 and Sensitivity for Respiration... 6.46 Recording or Printing the OCRG Trend... 6.47 Recording the OCRG Trend... 6.47 Printing the OCRG Trend... 6.48 User’s Guide PVM-2700

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CONTENTS

Section 7

Interbed Window... 7.1 Registering Interbed Beds... 7.3 Removing an Interbed Bed... 7.3 Displaying the Numeric Data of All Interbed Beds... 7.4 Displaying the Interbed Bed Data... 7.5 Interbed Alarm... 7.6 Interbed Alarm Setting... 7.7

Section 8

Recording... 8.1 Overview of Recording... 8.2 Recording Modes... 8.2 Manual Waveform Recording/Printing... 8.4 Recording/Printing on the Review Windows... 8.4 Periodic Recording... 8.4 Alarm Recording... 8.5 Recording on NIBP Measurement... 8.5 Recording Mode Annotations... 8.5 Recording Priority... 8.6 Recording Sensitivity... 8.6 Recording Speed... 8.6 Recording Related Message... 8.6 Recorded Data... 8.7 Changing the Recording Speed... 8.8 Changing the Recording Pattern... 8.9 Manually Recording/Printing Waveforms... 8.10 Recording Waveforms on the Optional Recorder Module... 8.10 Recording Waveforms on the Bedside Monitor with No Recorder... 8.11 Manual Printing on the Network Printer... 8.11 Setting Periodic Recording... 8.12 Changing Settings for Automatic Periodic Recording... 8.12 Printing on a Network Printer... 8.14 Recording on NIBP Measurement... 8.15

Section 9

ECG Monitoring... 9.1 General... 9.2 Preparing for ECG Monitoring... 9.3 Preparation Flowchart... 9.3 Number of Electrodes and Measuring Leads... 9.3 Electrode Position... 9.3 3 Electrode Leads... 9.3 6 Electrode Leads... 9.4 Electrode Positions for Detecting the Pacemaker Pulse... 9.5 Changing the Electrode Lead... 9.5 Changing the Electrode Positions... 9.5 Selecting Electrodes and Lead... 9.6 Types of Electrodes and Lead... 9.6 Connecting Cables and Attaching Disposable Electrodes... 9.7

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CONTENTS Connecting the Electrode Cable to the Monitor... 9.7 Attaching Disposable Electrodes to the Patient... 9.8 Monitoring ECG... 9.9 ECG Information on the Home Screen... 9.10 ECG Data Display... 9.10 Measuring ST Level... 9.11 Detached Electrode Detection and Display... 9.11 AC Interference and Display... 9.12 Monitoring Arrhythmia... 9.13 General... 9.13 Arrhythmia Analysis Data Display... 9.14 Changing Arrhythmia Monitoring Settings... 9.15 Turning Arrhythmia Analysis On or Off... 9.15 Selecting the Patient Type for QRS Detection... 9.16 Learning the ECG Waveform for Arrhythmia Detection (VPC Learning)... 9.17 Checking the Dominant QRS... 9.19 Changing ECG Settings... 9.21 Changing the Monitoring Lead... 9.22 Optimum Lead... 9.22 Changing a Lead... 9.23 Changing the ECG Sensitivity... 9.24 Changing the Heart Rate/Pulse Rate, VPC and ST Alarm Limits... 9.26 Checking Arrhythmia Alarm Settings... 9.27 Turning ECG Measurement On or Off... 9.30 Turning Pacing Spike Detection On or Off... 9.32 Changing the Number of Electrodes... 9.34 Selecting the Filter Type... 9.35 Changing the Sync Sound Source... 9.36 Use with an Electrosurgical Unit... 9.38

Section 10

Respiration Monitoring... 10.1 General... 10.2 Impedance Method... 10.2 Preparing for Respiration Monitoring in Impedance Method... 10.3 Preparation Flowchart... 10.3 Electrode Position and Waveform Examples... 10.3 Electrode Position... 10.4 Amplitude... 10.4 Connecting Cables and Attaching Disposable Electrodes... 10.5 Monitoring Respiration... 10.6 Respiration Information on the Home Screen... 10.6 Changing Respiration Settings... 10.7 Changing the Monitoring Lead in Impedance Method... 10.7 Changing the Respiration Sensitivity... 10.8 Turning Respiration Measurement On or Off in Impedance Method... 10.10 Changing the Respiration Rate and Apnea Alarm Limits... 10.11 Changing the Respiration Waveform Sweep Speed... 10.13

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CONTENTS

Section 11

CO2 Monitoring... 11.1 General... 11.2 Mainstream Method... 11.2 Measurement Error with the TG-900P/TG-920P CO2 Sensor Kit... 11.3 Use with Volatile Anesthetic Agents... 11.4 Preparing for CO2 Monitoring... 11.5 Preparation Flowchart... 11.5 Mainstream Method... 11.5 Types of CO2 Sensor Kits for Mainstream Method... 11.5 TG-900P CO2 Sensor Kit... 11.6 TG-920P CO2 Sensor Kit... 11.6 TG-950P CO2 Sensor Kit... 11.8 TG-970P or TG-980P CO2 Sensor Kit... 11.9 Connecting the CO2 Sensor Kit to the Monitor... 11.10 Connecting the CO2 Sensor Kit to the Respiration Circuit... 11.10 Performing Zero Calibration when Using a TG-950P, TG-970P or TG-980P CO2 Sensor Kit... 11.10 Calibrating by Air... 11.11 Calibrating with N2 Gas... 11.12 Monitoring CO2 ... 11.13 CO2 Information on the Home Screen... 11.13 Changing CO2 Settings... 11.15 Changing the Scale... 11.15 Changing the CO2, Respiration Rate and Apnea Alarm Limits... 11.16 Setting the Inspiration Composition... 11.17 Changing the CO2 Waveform Sweep Speed... 11.19 Changing Duration for Holding ETCO2 Maximum Value... 11.19 Inspection of Measuring Accuracy... 11.21 Daily Inspection of Measuring Accuracy... 11.21 Inspection of Measuring Accuracy (Precise Method)... 11.21

Section 12

SpO2 Monitoring... 12.1 General... 12.2 Preparing for SpO2 Monitoring... 12.4 Preparation Flowchart... 12.4 Selecting a Probe... 12.4 Nihon Kohden Reusable Probes... 12.4 Nihon Kohden Disposable Probes... 12.5 Connecting Cables and Attaching the Probes... 12.7 Connecting Cable to the Monitor... 12.7 Attaching the Probe to the Patient... 12.7 Monitoring SpO2 ... 12.8 SpO2 Information on the Home Screen... 12.9 Changing SpO2 Settings... 12.10 Changing the Sensitivity... 12.10 Changing the SpO2 and Pulse Rate Alarm Limits... 12.12 Changing the Sync Sound Source... 12.13 Selecting Sync Sound Pitch... 12.15

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CONTENTS Selecting the Response Mode... 12.16 Selecting SpO2 Sensitivity Mode... 12.17 Displaying Pulse Rate and Pulse-amplitude Index (PI) on the Home Screen... 12.18 Displaying the SQI Bar Graph on the Home Screen... 12.18

1 2 3

Section 13

NIBP Monitoring... 13.1 General... 13.2 Oscillometric Method... 13.2 Measurement Method (Deflation Mode and Inflation Mode)... 13.3 Deflation Method... 13.3 Inflation Method... 13.3 Precautions on the Inflation Method... 13.4 Preparing for NIBP Measurement... 13.5 Preparation Flowchart... 13.5 Selecting the Cuff... 13.5 Types of Cuffs... 13.7 Connecting Cables and Attaching the Cuff to the Patient... 13.9 Connecting Air Hose and Cuff to the Monitor... 13.9 Attaching the Cuff to the Patient... 13.10 Measuring and Monitoring NIBP... 13.14 Measurement Mode and Interval... 13.15 Manual Measurement... 13.15 Auto Measurement... 13.15 Auto Measurement with PWTT... 13.16 Auto Measurement on Upper/Lower Limit Alarm... 13.17 STAT Measurement... 13.17 SIM Mode Measurement... 13.17 NIBP Information on the Home Screen... 13.18 Dimming and Hiding the NIBP Data... 13.18 Displaying Pulse Rate from NIBP... 13.18 Performing NIBP Measurement... 13.19 Manual Measurement... 13.19 Auto Measurement... 13.20 Auto Measurement with PWTT Trigger... 13.23 Auto Measurement on Upper/Lower Limit Alarm... 13.25 STAT Measurement... 13.26 SIM Mode Measurement... 13.28 Changing NIBP Settings... 13.30 Selecting the Initial Cuff Inflation Pressure... 13.30 Selecting the Initial Cuff Inflation Pressure Type... 13.30 Setting the Cuff Inflation Pressure... 13.31 Turning the Inflation Mode On... 13.33 Changing the NIBP Alarm Limits... 13.35 Turning PWTT Trigger NIBP Measurement On/Off... 13.37 Using Venous Puncture Mode... 13.38

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CONTENTS

Section 14

IBP Monitoring... 14.1 General... 14.2 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 JP-940P IBP Connection Box... 14.4 Installing the Blood Pressure Measuring Device... 14.5 Connecting Cables to the Monitor... 14.5 Assembling the Transducer... 14.6 Adjusting Zero Balance... 14.8 Adjusting Zero Balance... 14.8 Memorizing the Zero Balance Values... 14.9 Monitoring IBP... 14.10 IBP Information on the Home Screen... 14.10 Changing IBP Settings... 14.11 Changing the IBP and Pulse Rate Alarm Limits... 14.11 Changing the Scale... 14.13 Changing the Sync Sound Source... 14.14 Selecting Sync Sound Pitch... 14.15 Selecting the Data Display Mode on the Home Screen... 14.17 Changing the Label... 14.18 Types of Labels... 14.18 Changing the Labels... 14.19 Displaying PPV or SPV on the Home Screen... 14.20 Selecting PPV or SPV Display on the Home Screen... 14.20

Section 15

Temperature Monitoring... 15.1 General... 15.2 Preparing for Temperature Monitoring... 15.3 Preparation Flowchart... 15.3 Selecting the Probe... 15.3 Reusable Probes... 15.3 Disposable Probes... 15.4 Connecting Cables and Attaching the Probe... 15.5 Connecting Cable to the Monitor... 15.5 Attaching the Probe to the Patient... 15.5 Using the Insulation Pad... 15.5 Monitoring Temperature... 15.6 Temperature Information on the Home Screen... 15.6 Changing Temperature Settings... 15.7 Changing the Temperature Alarm Limits... 15.7

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CONTENTS

Section 16

Reference... 16.1

1

Clock Accuracy... 16.2 Periodical Replacement Schedule... 16.3 Repair Parts Availability Policy... 16.3

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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 (2) (3) (4)

ventilated areas, and dust, saline or sulphuric air. Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport. Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. 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 specified parts must undergo regular maintenance inspection at the interval which is specified after the GENERAL HANDLING PRECAUTIONS section. (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition. User’s Guide PVM-2700

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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 representative. 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.

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User’s Guide PVM-2700

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 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.

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Caution - continued 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. 10. Use with radiation therapy equipment: When the equipment and/or system is used in a radiotherapy room, it may cause failure or malfunction due to electromagnetic radiation or corpuscular radiation. When you bring the equipment and/or system into a radiotherapy room, constantly observe the operation. Prepare countermeasures in case of failure or malfunction. If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden representative for additional suggestions.

WARNING 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 representative or Nihon Kohden representative.

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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.

Text Conventions in this Manual • Names of hard keys on the monitor are enclosed in square brackets: [CHECK] • 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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Explanations of the Symbols in this Manual and Instrument The following symbols found in this manual/instrument bear the respective descriptions as given. On panel or inside casing Symbol

Description

Symbol

“On” only for a part of instrument

High voltage Output (ZS socket. When QI-201P interface is installed.) Input/output terminal (Serial socket. When QI-202P interface is installed) Direct Current (DC) (When QI-203P interface is installed) Network socket (When QI-202P or QI-203P interface is installed)

“Off” only for a part of instrument Alternating current Battery charge Data input/output 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.

Protective earth Defibrillation-proof type CF applied part

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.

Equipotential terminal Attention, see instructions for use/Caution Serial number Date of manufacture Manufacturer

Description

*1 (Background color: blue)

Follow instructions for use

IPX1*1

Protected against vertically falling water drops

Symbol

Description

European representative *1 This symbol is on the bedside monitor with Rev. DA or later. On package Symbol

Description This way up

Keep away from rain

Fragile

Stacking limit by number

On screen Symbol

vi

Description

Symbol

Description

Alarm silence

Recorder door open

Audio off

Silence alarms key

Alarm suspended

Checking SD card

All alarms off, Upper/lower alarm limit off

SD card failure User’s Guide PVM-2700

Symbol

Description

Symbol

Description

Out of paper

NIBP

Record

NIBP interval

Menu

NIBP start

Home

NIBP stop

Non-paced

Adjust setting/Scroll data

QRS/pulse sync mark

Zoom in/Zoom out

Respiration sync mark

@

Battery status

Touch panel calibration Guide menu

Cascade display

WS-201P Recorder Module Symbol

Description

Symbol

Attention, see instructions for use/Caution Date of manufacture

Description Serial number

(Background color: blue)

Follow instructions for use

Manufacturer

This way up

European representative

Fragile

Stacking limit by number

Keep away from rain

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.

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.

SB-201P Battery Pack Symbol

Description Recycle mark Attention, consult operator’s manual Manufacturer European representative 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.

User’s Guide PVM-2700

Symbol

Description Insert direction Products marked with this symbol comply with an environmental protection use period of 10 years according to the SJ/T11364 “Marking for the Restricted Use of Hazardous Substances in Electronic and Electrical Products” of the People’s Republic of China Electronic Industry Standard. Products marked with this symbol require separate waste collection according to EU battery directive 2006/66/EC. vii