cardiofax M ECG-1350 A & K Operators Manual Eleventh Edition Jan 2013

Electrocardiograph ECG-1350 ECG-1350A ECG-1350K

If you have any comments or suggestions on this manual, please contact us at: www.nihonkohden.com

0614-010451J

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.

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 Explanations of the Symbols in this Manual and Instrument... vi On Panel... vi On Operation Panel...vii On Screen...vii On Patient Cable...vii

3 4 5 6 7 8

Section 1

General... 1.1 Introduction... 1.2 Intended Use... 1.2 Features... 1.2 Composition... 1.2 General Safety Information... 1.4 General... 1.4 Installation... 1.4 Battery Pack... 1.6 Network... 1.7 Operation... 1.8 Maintenance... 1.9 Panel and Parts Descriptions... 1.10 Top View... 1.10 Operation Panel... 1.11 Right Side Panel... 1.13 Left Side Panel... 1.14 Rear Panel... 1.14 Patient Cable... 1.15 Functions... 1.16 Basic Operation... 1.18 Switching Screens... 1.19 AC Operation and Battery Operation... 1.20 AC Power Operation... 1.20 Battery Power Operation... 1.20 Battery Operation Time... 1.21

Section 2

Preparation... 2.1 Selecting a Suitable Location... 2.3 Connecting the Power Cord and Grounding the Electrocardiograph... 2.5 Connecting the Power Cord... 2.5 Grounding the Electrocardiograph... 2.5 Cutting Off the Power Supply to the Electrocardiograph... 2.6

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CONTENTS Operating on Battery... 2.7 Battery Handling... 2.7 Battery Replacement... 2.8 Charging... 2.8 Storage... 2.9 Disposing... 2.9 Inserting the Battery Pack... 2.10 Removing the Battery Pack... 2.11 Charging the Battery... 2.11 Setting the Recording Paper... 2.12 Handling the Recording Paper... 2.12 Types of Recording Paper... 2.12 Setting the Recording Paper... 2.14 Setting the Roll Type Recording Paper on the Cart... 2.15 Setting the Z-fold Type Recording Paper on the Cart... 2.16 Changing the Settings for the Recording Paper... 2.17 Out of Paper Indication... 2.17 Feeding the Recording Paper... 2.17 Connecting the Patient Cable... 2.18 Turning the Power On or Off... 2.19 Turning the Power On... 2.19 Check Items Before Turning the Power On... 2.19 Turning the Power On... 2.20 Check Items After Turning the Power On... 2.20 Changing the Date and Time... 2.21 Turning the Power Off... 2.21 Adjusting the Screen Brightness... 2.22 Connecting an External Instrument to the Electrocardiograph... 2.23 Connecting a USB Device to the Electrocardiograph... 2.24 Connectable Devices... 2.24 Connecting or Disconnecting a USB Device... 2.25 Preparing for Data Management... 2.26 About the Media... 2.26 Internal Memory... 2.26 SD Memory Card... 2.26 About the External Server... 2.26 Using the Internal Memory... 2.26 Using the SD Memory Card... 2.27 About the SD Memory Card... 2.27 Inserting and Removing the SD Memory Card... 2.28 Preparing the SD Memory Card... 2.29 Connecting the Electrocardiograph to a Network... 2.30 Using the Wired LAN... 2.31 Using the Wireless LAN... 2.31 Setting the IP Address, Subnet Mask and Default Gateway on the Electrocardiograph... 2.33 Connecting the Network Cable to the Electrocardiograph... 2.36 Inserting and Removing the SD Wireless LAN Card... 2.36

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Operator’s Manual ECG-1350

CONTENTS

Section 3

Changing Settings Before Measurement... 3.1 System Setup Screen and User Setup Screen... 3.2 List of Settings... 3.3 System Setup Screen... 3.3 Patient Information... 3.3 Wave Settings... 3.4 Communication Settings... 3.4 Recording Settings... 3.6 Periodic Recording Settings... 3.7 System Settings... 3.8 Bar Code... 3.9 Magnetic Card... 3.10 Key Settings... 3.10 User Setup Screen... 3.11 Wave Settings... 3.11 Communication Settings... 3.11 File Processing... 3.11 Recording Settings... 3.12 Changing the System Setup Settings... 3.15 Displaying the System Setup Screen and Changing the Settings... 3.15 Changing the Date and Time... 3.17 Synchronizing the Date and Time with the Server... 3.19 Entering the Hospital Name... 3.19 Assigning Symbols to the Number Keys... 3.20 Changing the User Setup Settings... 3.22 Saving the System Setup and User Setup Settings... 3.25 Loading the System Setup and User Setup Settings... 3.27 Printing the List of System Setup and User Setup Settings... 3.29

Section 4

Attaching the Electrodes and Entering Patient Information... 4.1 Attaching the Electrodes... 4.3 Attaching the Limb Electrodes... 4.3 Attaching the Chest Electrodes... 4.3 Patient Cable Tip Color Coding... 4.5 Lead Connection... 4.6 Standard 12 Leads and Cabrera Leads... 4.6 IEC Standard... 4.6 AHA Requirement... 4.6 Error Indication When the Electrode Is Not Attached Firmly... 4.7 Screen Message... 4.7 Indication on the Paper... 4.7 Countermeasure... 4.8 Electrode Detachment... 4.8 Large Polarization Voltage... 4.8 Entering the Patient Information... 4.9 General... 4.9 Manually Entering the Patient Information . ... 4.10

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CONTENTS Entering the Patient Information Using a Bar Code Reader or Magnetic Card Reader... 4.11 Entering the Patient Information by Searching on the Server... 4.12

Section 5

Recording Resting ECG Waveforms... 5.1 General... 5.2 Flow of Resting ECG Waveform Recording... 5.3 Notes for Accurate Measurement... 5.4 Before Starting the Recording... 5.4 Detecting QRS Waves... 5.4 Counting the Heart Rate... 5.4 Using the EMG/High-cut Filter... 5.4 ECG Analysis... 5.5 Resting ECG Recording Screen... 5.6 Displaying the Resting ECG Recording Screen... 5.6 Explanation of the Resting ECG Recording Screen... 5.7 Automatic Recording... 5.10 General... 5.10 Real Time Recording... 5.10 Review Recording... 5.10 Auto Gain and Auto Position... 5.10 Preparation for Automatic Recording... 5.11 Automatic Recording Procedure... 5.14 Extended Recording... 5.16 Saving the ECG Data File... 5.16 Sending the ECG Data File... 5.17 Printing Another Copy of the Recording Results... 5.18 Manual Recording... 5.20 General... 5.20 Preparation for Manual Recording... 5.20 Manual Recording Procedure... 5.21 Rhythm Recording... 5.24 General... 5.24 Rhythm Recording Procedure... 5.24 Recording Examples... 5.25 Auto Recording Examples... 5.25 Manual Recording Examples... 5.28 Rhythm Recording Examples... 5.31

Section 6

Periodic ECG Recording... 6.1 General... 6.2 Preparation for Periodic ECG Recording... 6.3 Recording Procedure... 6.4 Recording Examples... 6.5

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CONTENTS

Section 7

External Signal Recording... 7.1 General... 7.2 Connecting an External Instrument... 7.3 Recording Procedure... 7.4 Recording Example... 7.6

1 2 3 4

Section 8

Data Management... 8.1 General... 8.2 Displaying the Data Management Screen... 8.3 Sending ECG Data Files... 8.4 Displaying the Send Screen... 8.4 Sending All ECG Data Files... 8.4 Sending Unsent ECG Data Files... 8.6 Sending an ECG Data File of the Selected ID... 8.8 Sending an ECG Data File of the Selected Date... 8.10 Printing ECG Waveforms in a Media... 8.12 Editing ID... 8.13 Printing ECG Waveforms in the Server... 8.15 Deleting ECG Data Files... 8.16 Displaying the Delete Screen... 8.16 Deleting All ECG Data Files... 8.16 Deleting Sent ECG Data Files... 8.18 Deleting ECG Data Files of the Selected ID... 8.20 Deleting ECG Data Files of the Selected Date... 8.21 Formatting the Media... 8.23 Printing File List... 8.25 Copying Files in the Internal Memory to an SD Card... 8.26 When the Media is Full... 8.27

Section 9

Troubleshooting and Error Messages... 9.1 Recording Clear ECG Waveforms... 9.2 AC Interference... 9.2 Muscle Tremor Interference (EMG)... 9.2 Wandering Baseline... 9.3 Abnormal Printout... 9.3 Other... 9.4 Troubleshooting... 9.5 Error Messages... 9.8 Checking the Software Version... 9.10

Section 10

Maintenance and System Test... 10.1 Check Items After Turning the Power Off... 10.2 Cleaning and Disinfecting the Electrocardiograph... 10.3 Cleaning and Disinfecting the Surface of the Electrocardiograph... 10.3 Cleaning the Display of the Electrocardiograph... 10.4 Cleaning the Thermal Head... 10.4

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5 6 7 8 9 10 11

CONTENTS Cleaning the Paper Roller... 10.4 Cleaning the Sensors... 10.5 Cleaning the Wheel Gear... 10.5 Cleaning and Disinfecting the Patient Cable... 10.6 Cleaning... 10.6 Disinfecting... 10.6 Cleaning and Disinfecting Electrodes... 10.7 Cleaning... 10.7 Disinfecting... 10.7 Cleaning and Disinfecting Other Options... 10.7 Regular Check... 10.8 Clock Accuracy... 10.9 Periodic Replacement... 10.10 Repair Parts Availability Policy... 10.10 System Test Screen... 10.11 Displaying the System Test Screen... 10.12

Section 11

Reference... 11.1 Specifications... 11.2 ECG Input... 11.2 Waveform Data Processor... 11.2 Recorder... 11.2 External Input/Output... 11.2 Power Requirement... 11.2 Color LCD (with backlight)... 11.3 Environment... 11.3 Performance... 11.3 Dimensions and Weight... 11.3 Safety Standard... 11.3 Electromagnetic Compatibility... 11.4 Electromagnetic Emissions... 11.4 Electromagnetic Immunity... 11.5 Recommended Separation Distances between Portable and Mobile RF Communications Equipment... 11.7 System Composition for EMC Test... 11.7 General Requirements for Connecting Medical Electrical Systems... 11.8 Standard Accessories... 11.10 Options and Consumables... 11.11 Optional Accessory Kit... 11.11 Options for the Electrocardiograph... 11.12 Connector Pin Assignment... 11.13 Attaching the Ferrite Core... 11.13 EXT-IN 1, EXT-IN 2, CRO-OUT Connectors... 11.13

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Operator’s Manual ECG-1350

GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel. Use only Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input boxes and AC power. Please read these precautions thoroughly before attempting to operate the instrument. 1. To safely and effectively use the instrument, its operation must be fully understood. 2. When installing or storing the instrument, take the following precautions: (1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly ventilated areas, and dust, saline or sulphuric air. (2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport. (3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. (4) The power line source to be applied to the instrument must correspond in frequency and voltage to product specifications, and have sufficient current capacity. (5) Choose a room where a proper grounding facility is available. 3. Before Operation (1) Check that the instrument is in perfect operating order. (2) Check that the instrument is grounded properly. (3) Check that all cords are connected properly. (4) Pay extra attention when the instrument is combined with other instruments to avoid misdiagnosis or other problems. (5) All circuitry used for direct patient connection must be doubly checked. (6) Check that battery level is acceptable and battery condition is good when using battery-operated models. 4. During Operation (1) Both the instrument and the patient must receive continual, careful attention. (2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety. (3) Avoid direct contact between the instrument housing and the patient. 5. To Shutdown After Use (1) Turn power off with all controls returned to their original positions. (2) Remove the cords gently; do not use force to remove them. (3) Remove the power cord from the AC SOURCE socket to isolate the instrument form the AC supply mains. (4) Clean the instrument together with all accessories for their next use. 6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order. 7. The instrument must not be altered or modified in any way. 8. Maintenance and Inspection (1) The instrument and parts must undergo regular maintenance inspection at least every 6 months. (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition. Operator’s Manual ECG-1350

i

(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. In the USA and Canada other warranty policies may apply.

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

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Operator’s Manual ECG-1350

EMC RELATED CAUTION This equipment and/or system complies with International Standard IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in 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. If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden representative for additional suggestions.

For EMC compliance, refer to “Specifications - Electromagnetic Compatibility” in the Reference section. 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. The CE mark only applies to the ECG-1350K Electrocardiograph.

NOTE about Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC For the member states of the European Union only: The purpose of WEEE directive 2002/96/EC is, as a first priority, the prevention of waste electrical and electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. Contact your Nihon Kohden representative for disposal.

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Operator’s Manual ECG-1350

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.

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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 Symbol

Description

Symbol

Description

Attention, consult operator’s manual

Date of manufacture

Alternating current

Serial number

Equipotential terminal

Data input/output

Type CF applied part

Eject (Magazine release button)

Input output terminal

SD card slot

CSA mark* 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 and Radio Equipment and Telecommunication Terminal Equipment 1999/5/EC.

* The CSA mark only applies to the ECG-1350A Electrocardiograph. ** The CE mark and WEEE mark only apply to the ECG-1350K Electrocardiograph.

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Operator’s Manual ECG-1350

On Operation Panel Symbol

Description

Symbol

Description

“On” only for a part of equipment

Mode

“Off” only for a part of equipment

Review

Battery charging

Paper feed

Battery check

Mark

Alternating current

EMG Filter

Patient (Male)

Copy

Patient (Female)

START/STOP recording

Age

Automatic control

Lead selection

Manual control

Gain

Rhythm

Paper speed

On Screen Symbol

Description

Symbol

QRS sync mark

Description CAL mark

On Patient Cable Symbol

Description Attention, consult operator’s manual

Operator’s Manual ECG-1350

Symbol

Description Defibrillation-proof Type CF applied part

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Section 1 General Introduction... 1.2 Intended Use... 1.2 Features... 1.2 Composition... 1.2 General Safety Information... 1.4 General... 1.4 Installation... 1.4 Battery Pack... 1.6 Network... 1.7 Operation... 1.8 Maintenance... 1.9 Panel and Parts Descriptions... 1.10 Top View... 1.10 Operation Panel... 1.11 Right Side Panel... 1.13 Left Side Panel... 1.14 Rear Panel... 1.14 Patient Cable... 1.15 Functions... 1.16 Basic Operation... 1.18 Switching Screens... 1.19 AC Operation and Battery Operation... 1.20 AC Power Operation... 1.20 Battery Power Operation... 1.20 Battery Operation Time... 1.21

Operator’s Manual ECG-1350

1.1

1

1. GENERAL

Introduction The cardiofax M ECG-1350A/ECG-1350K is an easy to use electrocardiograph with 12-channel recorder and built-in battery. NOTE Use only Nihon Kohden parts and accessories to assure maximum performance from your instrument.

Intended Use The Nihon Kohden ECG-1350A/ECG-1350K electrocardiograph is intended for medical use to process the electrical signals produced by the heart, which are acquired through two or more electrodes, and to display waveforms* and/ or prepare a record of these electrical signals. This instrument is a portable ECG acquisition terminal which measures up to 12 lead ECG waveforms. * Essential performance in EMC standard

Features • Compact, lightweight and easy to carry - A4 notebook size, 3.9 kg without battery or recording paper • Up to 12 channels on 210 mm recording paper • A color LCD screen allows you to preview 2.8 seconds of 12 lead ECG waveforms • SD memory card available • 2 channel external signal input available • 1 channel external signal output available • Data transmission through wired LAN or wireless LAN to personal computer or another electrocardiograph For ECG analysis, refer to the ECAPS 12C Interpretation Program User’s Guide.

Composition • Electrocardiograph, ECG-1350A/ECG-1350K Standard Accessories • Thermal head cleaner • Recording paper, FQW210-3-140 • Input check jig Options • Accessory kit, YD-121D/YD-122D/YD-123D/YD-124D • Patient cable, BJ-901D/BJ-902D/BJ-903D/BA-901D/BA-903D • Battery pack, NKB-301V • Cart, KD-105D/KD-105E 1.2

Operator’s Manual ECG-1350

1. GENERAL • Patient cable hanger, KH-100D • SD memory card, QM-001D • cardioCream, Z-101BC • USB-RS232C adapter, YZ-041H0 • USB-LAN adapter, YZ-041H1 • SD wireless LAN card, YZ-041H2 • USB hub • Bar code reader • Magnetic card reader • Medical isolation transformer

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1.3

1. GENERAL

General Safety Information General WARNING

WARNING

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

WARNING

WARNING

When the electrocardiograph 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 electrocardiograph, causing electrical burn where the electrodes are attached. For details, refer to the ESU manual.

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

WARNING

Before defibrillation, remove everything including electrodes and patches from the patient’s chest. If the defibrillator paddle contacts an object on the patient’s chest, the discharged energy may be insufficient and cause skin burn.

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

WARNING Use only the specified patient cables. Failure to follow this warning may cause skin burn where the electrode is attached and damage the electrocardiograph due to discharge energy when defibrillation is performed.

Installation WARNING Connect only the specified instrument to the electrocardiograph and follow the specified procedure. Failure to follow this warning may result in electrical shock or injury to the patient and operator, and cause fire or instrument malfunction.

1.4

WARNING Install non-medical instruments which are connected to the electrocardiograph outside the patient environment (IEC 60601-1-1). If they are installed inside the patient environment, the patient or operator may receive electrical shock or injury. For installation, contact your Nihon Kohden representative.

Operator’s Manual ECG-1350