Manual Cardiofax 1150

Electrocardiograph ECG-1150

OPERATOR’S MANUAL


First Edition: 17 Feb 2009 Fifth Edition: 30 Aug 2012

0614-901906D Printed: 2012/09/24


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

0614-901906D

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

1 2

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............................................................................................... 1.3 General................................................................................................................... 1.3 Installation.............................................................................................................. 1.3 Battery Pack........................................................................................................... 1.5 Operation................................................................................................................ 1.6 Maintenance........................................................................................................... 1.7 Panel and Parts Descriptions............................................................................................ 1.8 Front Panel............................................................................................................. 1.8 Left Side Panel....................................................................................................... 1.8 Operation Panel...................................................................................................... 1.9 Right Side Panel................................................................................................... 1.10 Rear Panel............................................................................................................ 1.11 Patient Cable........................................................................................................ 1.11 Functions........................................................................................................................ 1.12 Basic Operation (Function Keys, Panel Keys, Number Keys)......................................... 1.14 Switching Screens.......................................................................................................... 1.15 AC and Battery Operation............................................................................................... 1.16 Power and Battery Status Indications................................................................... 1.17

Section 2

Preparation............................................................................. 2.1 Selecting a Suitable Location........................................................................................... 2.2 Mounting the Electrocardiograph on the Optional Cart..................................................... 2.4 Mounting the Electrocardiograph on the Cart......................................................... 2.4 Options for the Cart................................................................................................ 2.4 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

Operator’s Manual ECG-1150

C.1

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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 Recording Paper......................................................................................... 2.12 Storage....................................................................................................... 2.12 Usage......................................................................................................... 2.13 Replacement.............................................................................................. 2.13 Setting the Recording Paper................................................................................. 2.14 Feeding the Paper................................................................................................ 2.15 Connecting the Patient Cable......................................................................................... 2.16 Turning the Power On or Off........................................................................................... 2.17 Turning the Power On........................................................................................... 2.17 Check Items Before Turning the Power On................................................. 2.17 Turning the Power On................................................................................. 2.18 Check Items After Turning the Power On.................................................... 2.18 Changing the Date and Time................................................................................ 2.19 Turning the Power Off........................................................................................... 2.19 Adjusting the Screen Brightness..................................................................................... 2.20 Preparing for Data Management.................................................................................... 2.21 About the Media................................................................................................... 2.21 Internal Memory......................................................................................... 2.21 SD Memory Card........................................................................................ 2.21 Using the Internal Memory................................................................................... 2.21 Using the SD Memory Card.................................................................................. 2.21 About the SD Memory Card....................................................................... 2.21 Inserting and Removing the SD Memory Card.......................................... 2.23 Preparing the SD Memory Card................................................................. 2.23

Section 3

Changing Settings Before Measurement............................. 3.1 System Setup Screen and Main Setup Screen................................................................ 3.2 List of Settings.................................................................................................................. 3.3 System Setup Screen............................................................................................. 3.3 Patient Information....................................................................................... 3.3 Wave Settings............................................................................................... 3.3 Recording Settings....................................................................................... 3.4 Periodic Recording Settings......................................................................... 3.5 System Settings........................................................................................... 3.6 Main Setup Screen................................................................................................. 3.7 Wave Settings............................................................................................... 3.7 File Processing............................................................................................. 3.7

C.2


CONTENTS Recording Settings....................................................................................... 3.7 Changing the System Setup Settings............................................................................... 3.9 Displaying the System Setup Screen and Changing the Settings.......................... 3.9 Changing the Date and Time................................................................................ 3.11 Entering the Hospital Name.................................................................................. 3.12 Changing the Main Setup Settings................................................................................. 3.14 Saving the System Setup and Main Setup Settings....................................................... 3.16 Loading the System Setup and Main Setup Settings..................................................... 3.18 Printing the List of System Setup and Main Setup Settings........................................... 3.20

1 2 3 4 5 6

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......................................................................................... 4.4 Lead Connection............................................................................................................... 4.5 Standard 12 Leads and Cabrera Leads................................................................. 4.5 IEC Standard................................................................................................ 4.5 AHA Requirement........................................................................................ 4.5 Error Indication When the Electrode Is Not Attached Firmly............................................. 4.6 Screen Message..................................................................................................... 4.6 Indication on the Paper........................................................................................... 4.7 Countermeasure..................................................................................................... 4.7 Electrode Detachment.................................................................................. 4.7 Large Polarization Voltage............................................................................ 4.7 Entering the Patient Information....................................................................................... 4.8 General................................................................................................................... 4.8 Entering the Patient Information ............................................................................ 4.9

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......................................................................................................... 5.9 General................................................................................................................... 5.9 Real Time Recording.................................................................................... 5.9 Review Recording........................................................................................ 5.9 Auto Gain and Auto Position......................................................................... 5.9


C.3

7 8 9 10

CONTENTS Preparation for Automatic Recording...................................................................... 5.9 System Setup............................................................................................. 5.10 Main Setup................................................................................................. 5.10 Automatic Recording Procedure........................................................................... 5.12 Extended Recording................................................................................... 5.14 Saving the ECG Data File.......................................................................... 5.14 Printing Another Copy of the Recording Results.................................................. 5.15 Manual Recording........................................................................................................... 5.16 General................................................................................................................. 5.16 Preparation for Manual Recording........................................................................ 5.16 System Setup............................................................................................. 5.16 Main Setup................................................................................................. 5.16 Manual Recording Procedure............................................................................... 5.17 Rhythm Recording.......................................................................................................... 5.19 General................................................................................................................. 5.19 Rhythm Recording Procedure.............................................................................. 5.19 Recording Examples....................................................................................................... 5.20 Auto Recording Examples.................................................................................... 5.20 Manual Recording Examples................................................................................ 5.21 Rhythm Recording Examples............................................................................... 5.21

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

Section 7

Data Management.................................................................. 7.1 General............................................................................................................................. 7.2 Displaying the Data Management Screen........................................................................ 7.3 Printing ECG Waveforms in a Media................................................................................ 7.4 Editing ID.......................................................................................................................... 7.6 Deleting ECG Data Files................................................................................................... 7.9 Displaying the Delete Screen................................................................................. 7.9 Deleting All ECG Data Files................................................................................... 7.9 Deleting ECG Data Files of the Selected ID......................................................... 7.11 Deleting ECG Data Files of the Selected Date..................................................... 7.13 Formatting the Media...................................................................................................... 7.16 Printing File List.............................................................................................................. 7.18 Copying Files in the Internal Memory to an SD Card..................................................... 7.20

Section 8

Troubleshooting and Error Messages.................................. 8.1 Recording Clear ECG Waveforms.................................................................................... 8.2 AC Interference....................................................................................................... 8.2 Muscle Tremor Interference (EMG)......................................................................... 8.2 Wandering Baseline................................................................................................ 8.3

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CONTENTS Abnormal Printout................................................................................................... 8.3 Other....................................................................................................................... 8.4 Troubleshooting................................................................................................................. 8.5 Error Messages................................................................................................................ 8.7 Checking the Software Version......................................................................................... 8.9

1 2 3 4

Section 9

Maintenance and System Test.............................................. 9.1 Check Items After Turning the Power Off.......................................................................... 9.2 Cleaning and Disinfecting the Electrocardiograph............................................................ 9.3 Cleaning the Surface of the Electrocardiograph..................................................... 9.3 Cleaning the Display of the Electrocardiograph...................................................... 9.3 Disinfecting the Surface of the Electrocardiograph................................................. 9.4 Cleaning the Thermal Head.................................................................................... 9.4 Cleaning the Paper Roller....................................................................................... 9.5 Cleaning the Sensor............................................................................................... 9.5 Cleaning the Wheel Gear....................................................................................... 9.5 Cleaning and Disinfecting the Patient Cable..................................................................... 9.6 Cleaning................................................................................................................. 9.6 Disinfecting............................................................................................................. 9.6 Cleaning and Disinfecting Electrodes............................................................................... 9.7 Cleaning................................................................................................................. 9.7 Disinfecting............................................................................................................. 9.7 Cleaning and Disinfecting Other Options.......................................................................... 9.7 Regular Check.................................................................................................................. 9.8 Clock Accuracy................................................................................................................. 9.9 Periodic Replacement..................................................................................................... 9.10 Repair Parts Availability Policy........................................................................................ 9.11 System Test Screen........................................................................................................ 9.12 System Test Items................................................................................................ 9.12 Displaying the System Test Screen...................................................................... 9.13

Section 10 Reference.............................................................................. 10.1 Specifications.................................................................................................................. 10.2 ECG Input................................................................................................... 10.2 Waveform Data Processor.......................................................................... 10.2 Recorder..................................................................................................... 10.2 Power Requirement.................................................................................... 10.2 Color LCD (with backlight).......................................................................... 10.3 Environment............................................................................................... 10.3 Performance............................................................................................... 10.3 Dimensions and Weight.............................................................................. 10.3 Safety Standard.......................................................................................... 10.3 Electromagnetic Compatibility.................................................................... 10.4 Electromagnetic Emissions........................................................................ 10.4 Electromagnetic Immunity.......................................................................... 10.5 Recommended Separation Distances between Portable and Mobile RF Communications Equipment................................................................. 10.7 Operator’s Manual ECG-1150

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5 6 7 8 9 10

CONTENTS System Composition for EMC Test............................................................. 10.7 General Requirements for Connecting Medical Electrical Systems................................ 10.8 Standard Accessories................................................................................................... 10.10 Options and Consumables........................................................................................... 10.11 Optional Accessory Kit....................................................................................... 10.11 Options for the Electrocardiograph..................................................................... 10.12 Character Code List...................................................................................................... 10.13 How to Read the Character Code List................................................................ 10.13

C.6


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:

3.

(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.

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-1150

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.

ii


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.


iii

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.

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.

iv


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.


v

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

Description

Attention, consult operator’s manual

Date of manufacture

Alternating current

Serial number

Equipotential terminal

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.

Type CF applied part Input output terminal Data input/output Eject (Magazine release button) SD card slot

vi

Symbol

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.


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


Symbol

Description Defibrillation-proof Type CF applied part

vii

Section 1 General Introduction........................................................................................................................................................... 1.2 Intended Use.............................................................................................................................................. 1.2 Features..................................................................................................................................................... 1.2 Composition............................................................................................................................................... 1.2 General Safety Information................................................................................................................................... 1.3 General....................................................................................................................................................... 1.3 Installation.................................................................................................................................................. 1.3 Battery Pack............................................................................................................................................... 1.5 Operation.................................................................................................................................................... 1.6 Maintenance............................................................................................................................................... 1.7 Panel and Parts Descriptions............................................................................................................................... 1.8 Front Panel................................................................................................................................................. 1.8 Left Side Panel........................................................................................................................................... 1.8 Operation Panel......................................................................................................................................... 1.9 Right Side Panel....................................................................................................................................... 1.10 Rear Panel............................................................................................................................................... 1.11 Patient Cable............................................................................................................................................ 1.11 Functions............................................................................................................................................................ 1.12 Basic Operation (Function Keys, Panel Keys, Number Keys)............................................................................. 1.14 Switching Screens.............................................................................................................................................. 1.15 AC and Battery Operation.................................................................................................................................. 1.16 Power and Battery Status Indications...................................................................................................... 1.17


1.1

1

1. GENERAL

Introduction The cardiofax C ECG-1150 is an easy to use electrocardiograph with 3-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-1150 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 — smaller than A4 paper, 2 kg without battery or recording paper • Prints up to 3 channels on 63 mm recording paper • An LCD screen lets you preview 2.8 seconds of 12 lead ECG waveforms • SD memory card available For ECG analysis, refer to “ECAPS 12C ECG Interpretation Program User’s Guide”.

Composition • Electrocardiograph, ECG-1150 Standard Accessories • Thermal head cleaner • Recording paper, RQS63-3 • Input check jig

1.2

Options • Accessory kit, YD-100D/YD-101D/YD-102D/YD-103D • Patient cable, BJ-901D/BJ-902D/BJ-903D/BA-901D/BA-903D/BJ-961D • Battery pack, SB-901D • Cart, KD-104E/KD-105D/KD-105E • Storage rack, DI-010D • Patient cable hanger, KH-100D • SD memory card, QM-064DE (for Europe), QM-001D/064D (for other countries) • Cardio cream, Z-101BC • Medical isolation transformer Operator’s Manual ECG-1150

1. GENERAL

1

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.


WARNING Only use the provided power cord. When the provided power cord cannot be used or when equipotential grounding is doubtful (such as in a facility with poor grounding), operate the electrocardiograph on battery power. Otherwise, the patient and operator may receive electrical shock or injury.

1.3

1. GENERAL

WARNING

WARNING

When several medical instruments are used together, ground all instruments to the same onepoint ground. Any potential difference between instruments may cause electrical shock to the patient and operator.

Never use a local purchase multiple portable socket outlet. Failure to follow this warning may cause electrical shock to the patient and operator.

WARNING

WARNING

Do not put the multiple portable socket outlet on a floor. If the multiple portable socket outlet gets dusty, damaged or contacts liquid, it may cause instrument malfunction and electrical shock to the patient or operator.

To use non-medical equipment that requires an isolation transformer, only connect it to a specified multiple portable socket outlet that has an isolation transformer. Do not connect the nonmedical equipment to a wall AC socket or to a multiple portable socket that does not have an isolation transformer. Do not connect unspecified electrical instruments to a multiple portable socket outlet in the system. Failure to follow this warning may cause leakage current to increase and the patient and operator may receive electrical shock or injury.

WARNING Do not use an additional multiple portable socket outlet or extension cord. The impedance of the protective earth increases and the patient and operator may receive electrical shock or injury.

Cart

CAUTION Only use the KD-104E/105D/105E cart for this electrocardiograph. If another cart is used, it may tip over or the electrocardiograph may fall off.

CAUTION • Do not move the cart with the casters locked. The cart may tip over. • When moving the cart, hold the handle only.

CAUTION

CAUTION

When moving the cart with patient cable hanger mounted, fold the upper and lower arms together, rotate the arms so that they point toward the handle and do not protrude beyond the edges of the cart.

To prevent the cart from tipping over or the electrocardiograph falling off the cart: • Do not put or hook anything on the handle. • Do not ride on the cart. Do not lean on the handle or put your weight on the cart. • Periodically check that the casters, handle and frame are firmly attached and not wobbly. • Always lock the casters so that the cart does not move accidentally.

1.4


1. GENERAL Accessories and Consumables

CAUTION Do not leave accessories and consumables such as electrodes or electrolyte cream (CardioCream) near the patient or in reach of children. If they are swallowed, consult a physician immediately.

1 CAUTION Only use Nihon Kohden specified parts and accessories to assure maximum performance from your electrocardiograph. Using unspecified recording paper or electrodes may cause incorrect ECG recording and accelerate deterioration of the electrocardiograph.

Battery Pack WARNING

WARNING

Do not do the following to the battery pack. It may cause leakage, overheating, explosion and fire. • Short-circuit the + and – terminals on the battery pack. • Put the battery pack into fire or heat the battery pack. • Disassemble or modify the battery pack. • Give strong impact to or deform the battery pack. • Use the battery pack on unspecified instruments. • Charge the battery pack on unspecified instruments. • Install the battery pack with the wrong polarity. • Leave the battery pack in the reach of patients.

If the liquid inside the battery contacts the eyes, mouth or skin, do not rub the eyes, mouth or skin. Wash with clean water and see a physician immediately.

WARNING The following may cause overheating and leakage of the battery pack. • Leaving the battery pack unused for a long period (more than a year) • Immersing the battery pack in water or sea water or getting it wet

WARNING Only use the SB-901D battery pack.

CAUTION If the battery operation time is less than 15 minutes, the battery pack may be deteriorated. Do not charge a deteriorated battery pack. Charging a deteriorated battery pack may cause the electrocardiograph to fail to operate in both battery and AC power.


CAUTION Do not use or leave the battery pack in direct sunlight or high temperatures such as in a car in hot weather or in front of a stove. It may cause leakage of the battery pack and degrade the performance and lifetime of the battery pack.

1.5

1. GENERAL

CAUTION The battery pack must be replaced by qualified service personnel.

CAUTION SB-901D battery pack is NiMH (Nickel-Metal Hydride). Before disposing of the battery pack, check with your local solid waste officials for details in your area for recycling options or proper disposal. The battery is recyclable. At the end of its useful life, under various state and local laws, it may be illegal to dispose of this battery into the municipal waste stream.

Operation WARNING

WARNING

Do not touch the patient while touching any metal part of non-medical electrical equipment or an exposed part when a connector or cover is removed. Failure to follow this warning may cause electrical shock or injury to the patient.

Do not connect the tip of the electrode lead to anything other than an electrode. Connect all the tips to the corresponding electrodes and attach them to the patient. If unconnected tips or electrodes contact an item which is not equipotential grounded, the patient may receive electrical shock. Also, noise may superimpose on the ECG waveforms and measurement data may be incorrect.

CAUTION

CAUTION

Enter the patient information correctly. Otherwise, the ECG data may be lost or mixed up with another patient’s ECG data. When managing examination data that is only in electronic file, make sure to enter the patient information.

Do not use the output signal from the output connector of the electrocardiograph for a synchronization signal on a defibrillator. There is a time delay between the input signal and output signal. When using the output signal from the electrocardiograph for the synchronization signal on other instrument, always consider this time delay.

CAUTION The paper cutter in the recording paper container is sharp. When setting the recording paper, be careful not to cut your finger. Set the recording paper as specified.

1.6


1. GENERAL ECG Recording Judgement

CAUTION • The automatic ECG interpretation is performed for acquired ECG waveforms only and does not reflect all conditions of the patient. The results of the analysis might not correspond to the judgement of a physician. • Overall judgement must be performed by the physician, referring to the analysis result, clinical findings, and other examination results. After the physician’s overall judgement, the analysis results should be signed or initialed by the physician.

1 CAUTION Take care when judging the ECG recording because the EMG filter may cause distortion of P-waves and QRS-waves depending on the waveform shape.

Maintenance CAUTION Before maintenance, cleaning or disinfection, turn the electrocardiograph power off and disconnect the power cord from the AC socket. Failure to follow this instruction may result in electrical shock and electrocardiograph malfunction.


1.7

1. GENERAL

Panel and Parts Descriptions Front Panel

2

3

1 Name

Function

1 Operation panel

Refer to next page.

2 Paper container

Contains the recording paper.

3 LCD screen

Displays ECG waveforms, patient information, marks and message.

Left Side Panel 1

Name

Function

1 Recorder door release button

Press this button to open the recorder door.

2 Patient cable connector

Connects the patient cable.

1.8

2


1. GENERAL

Operation Panel

1 7 8

4

2

3 9 10

1

5

6 11

12

13

14

15

Name

Function

1

AC power lamp

Lit when AC power is supplied.

2

Battery operation lamp

During battery operation, indicates the remaining battery power with the color and lighting state. For details, refer to “AC and Battery Operation” later in this section.

3

Battery charge lamp

Indicates the battery charge status. For details, refer to “Operating on Battery” in Section 2. NOTE After charging is complete, the battery charge lamp lights about every half hour to one hour. This is because a small current is supplied to the battery (supplementary recharging) to prevent self-discharging of the battery. Keep the power cord plugged into the AC socket when the electrocardiograph is not used.

4

POWER key/lamp

Turns the electrocardiograph on/off. For details, refer to “AC and Battery Operation” later in this section.

5

MODE key (“4” number key) Calls up the Main menu screen. On some screens, this key enters the number “4”.

6

RHYTHM key/lamp (“5” number key)

Performs rhythm recording in resting ECG examination. The lamp is lit while waveforms are acquired. On some screens, this key enters the number “5”.

7

F1, F2, F3, F4 function keys (“1”, “2”, “3” number keys)

Correspond to the four items at the bottom of the screen. On some screens, these keys enter the number “1”, “2” and “3”.

8

ID key

Use to enter patient information.

9

AGE key (“6” number key)

Selects the patient age range (child or adult). On some screens, this key enters the number “6”.

10 GENDER key (“7” number key)


Selects the patient gender. On some screens, this key enters the number “7”.

1.9

1. GENERAL

11

Name

Function

FEED/MARK key (“8” number key)

Paper feeding: Feeds the paper while the key is pressed. Event mark: In manual recording mode, adds an event mark to the ECG waveform. On some screens, this key enters the number “8”.

12 FILTER key/lamp (“9” number key)

Turns the EMG filter on/off. The lamp lights when the EMG filter is turned on. On some screens, this key enters the number “9”.

13 COPY/CAL key lamp (“0” number key)

Automatic recording mode and rhythm recording mode: Prints copies of the recording results. The lamp lights when copy is available and during printing. Manual recording mode: Records the calibration waveforms. This key does not function for external input signals. On some screens, this key enters the number “0”.

14 START/STOP key/lamp

Starts or stops recording. The lamp lights during recording.

15 AUTO/MANUAL key/lamp

Selects automatic or manual recording. Lamp on: automatic recording Lamp off: manual recording

The MODE, RHYTHM, F1, F2, F3, AGE, GENDER, FEED/MARK, FILTER and COPY/CAL keys are used to enter numbers in the System Setup screen and patient information. Refer to “Changing the System Setup Settings” in Section 3 and “Entering the Patient Information” in Section 4.

Right Side Panel 1

3

2 Name

Function

1 SD card slot

For an SD memory card (option).

2 AC power cord socket

Connects the power cord to supply AC power to the electrocardiograph.

3 Equipotential grounding terminal

For a grounding lead. When equipotential grounding is required, always perform equipotential grounding by using the optional grounding lead. NOTE • The equipotential grounding terminal can be removed. Be careful not to lose the terminal. • Only use Nihon Kohden specified equipotential grounding terminal.

1.10


1. GENERAL

Rear Panel

1

1

Name 1 Battery compartment

Function Contains the battery pack.

CAUTION Always install the battery even when the electrocardiograph operates on AC power. Otherwise sudden power off occurs when an electrode is detached during recording.

Patient Cable 1

2 Name

Function

1 Electrode leads

Connects to chest or limb electrodes.

2 Connector

Connects the leads to the electrocardiograph.


1.11

1. GENERAL

Functions ECG recording (Refer to Section 5) Automatic recording Real time recording Review recording Analysis result recording Rhythm recording One minute of one rhythm lead ECG waveform recording Extended recording Extended arrhythmia rhythm recording Extended sequence recording Extended recording (manual) Copy (manual) ECG data storage (manual) Manual recording ECG manual recording Periodic recording Automatic recording Real time recording Periodic recording ECG data storage Manual recording ECG data management (Refer to Section 7) Print saved ECG waveforms Change the ID of the saved file Delete ECG data files Format a media Print ECG data file list Copy ECG data files in the internal memory to SD card Settings (System setup screen) (Refer to Section 3) • Patient information • Wave settings • Recording settings - Auto recording - Report print out - Analysis format and settings • Periodic recording settings • System settings • Save/Load/Print system settings

1.12


1. GENERAL To display the System Setup screen 1. Turn the power off. 2. Press the POWER key while pressing the FILTER key.

1

Settings (Main setup screen) (Refer to Section 3) • Wave settings • File processing • Recording settings - Recorder - Manual recording - Auto recording - Analysis format and settings - Rhythm recording To display the Main Setup screen Select Setup from the Main Menu screen. Setting (Brightness screen) (Refer to Section 2) Adjusting the screen brightness System test (Refer to Section 9) • Demonstration waveform • Recorder test • Key test • Memory test • LCD/LED test • Electrode input test • ECG input circuit test • Initialize system settings • Display internal information • Display model information To display the System Test screen 1. Turn the power off. 2. Press the POWER key while pressing the FEED/MARK key.


1.13

1. GENERAL

Basic Operation (Function Keys, Panel Keys, Number Keys) The electrocardiograph has function keys on the screen and dedicated keys on the operation panel.

Function Keys Press the function key (F1 - F4) corresponding to the operation or item displayed on the bottom of the screen to perform the desired operation or select the desired item.

Panel Keys Press the key on the operation panel to perform the desired operation. Some of the panel keys also function as number keys on some screens. Number Keys On some screens, you can press the panel key to enter a number (0 - 9).

1.14


1. GENERAL

1

Switching Screens When the electrocardiograph is turned on, the Resting ECG recording screen appears.

To switch to another screen 1. Press the MODE key to display the Main Menu screen.

2. Use the number keys on the operation panel to select the number of the desired item. Press the “1” or “2” key on the Main Menu screen to return to the ECG recording screen.


1.15

1. GENERAL

AC and Battery Operation AC power operation: When AC power is supplied, the electrocardiograph operates on AC power and the AC power lamp is lit. Lit AC power lamp on

CAUTION Always install the battery even when the electrocardiograph operates on AC power. Otherwise sudden power off occurs when an electrode is detached during recording.

Automatic backlight off In AC power operation, the electrocardiograph automatically turns the backlight off when the “Fail Limb” message (electrode detachment) is displayed on the screen and there is no key operation for approximately three minutes. To turn on the backlight, press any key. The automatic backlight off function can be turned off by setting “Backlight auto off” to “Off” on the System Setup screen. Refer to “List of Settings” in Section 3.

Lit

Battery operation lamp on

Battery power operation: When AC power is not supplied, the electrocardiograph automatically switches to battery power operation and the battery operation lamp lights to indicate the remaining battery power. The electrocardiograph can operate about 90 minutes with a new fully charged battery. NOTE • When the battery is almost discharged and the power is turned on, the “Charge battery” message appears, the battery operation lamp blinks in orange, a notification sounds and the electrocardiograph immediately turns the power off. • Automatic power off In battery operation, to prevent unwanted battery consumption, the electrocardiograph automatically turns the power off when the “Fail Limb” message (electrode detachment) is displayed on the screen and there is no key operation for approximately three minutes. In this case, temporarily changed settings are lost. If this happens, turn the power back on to continue using the electrocardiograph. The automatic power off function can be turned off by setting “Auto power off” to “Off” on the System Setup screen. Refer to “List of Settings” in Section 3.

1.16


1. GENERAL Battery operation time: NOTE Remaining battery power depends on the surrounding temperature and quality of recording waveform. Battery operation lamp Lights in green Lights in orange Blinks in orange

Available recording time At least 15 minutes. 90 minutes or more when fully charged. 1 to 15 minutes Power will be lost within one minute. Recharge the battery immediately or operate on AC power.

Power and Battery Status Indications Power and battery status are indicated by four lamps on the front panel. A discharged battery is also indicated by a screen message. Lit

• Operating on AC power Power lamp: Lit AC power lamp: Lit Battery operation lamp: Off Battery charge lamp: Off

Lit

• Operating on battery power Power lamp: Lit AC power lamp: Off Battery operation lamp: Lit in green Battery charging lamp: Off

Lit

Lit in green Lit

• Operating on battery power and battery operation time is less than 15 minutes Power lamp: Lit AC power lamp: Off Battery operation lamp: Lit in orange Battery charging lamp: Off

Lit in orange

• Operating on battery power and battery needs recharging Power lamp: Lit AC power lamp: Off Battery operation lamp: Blink in orange Battery charging lamp: Off Screen indication: “Charge battery” message

Lit

Blink in orange

Lit

Lit Operator’s Manual ECG-1150

• Power off and charging battery Power lamp: Off AC power lamp: Lit Battery power lamp: Off Battery charging lamp: Lit

1.17

1

Section 2 Preparation Selecting a Suitable Location............................................................................................................................... 2.2 Mounting the Electrocardiograph on the Optional Cart........................................................................................ 2.4 Mounting the Electrocardiograph on the Cart............................................................................................ 2.4 Options for the Cart.................................................................................................................................... 2.4 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 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 Recording Paper............................................................................................................................ 2.12 Storage........................................................................................................................................... 2.12 Usage............................................................................................................................................. 2.13 Replacement.................................................................................................................................. 2.13 Setting the Recording Paper.................................................................................................................... 2.14 Feeding the Paper.................................................................................................................................... 2.15 Connecting the Patient Cable............................................................................................................................. 2.16 Turning the Power On or Off............................................................................................................................... 2.17 Turning the Power On............................................................................................................................... 2.17 Check Items Before Turning the Power On.................................................................................... 2.17 Turning the Power On..................................................................................................................... 2.18 Check Items After Turning the Power On....................................................................................... 2.18 Changing the Date and Time................................................................................................................... 2.19 Turning the Power Off............................................................................................................................... 2.19 Adjusting the Screen Brightness........................................................................................................................ 2.20 Preparing for Data Management........................................................................................................................ 2.21 About the Media....................................................................................................................................... 2.21 Internal Memory............................................................................................................................. 2.21 SD Memory Card........................................................................................................................... 2.21 Using the Internal Memory....................................................................................................................... 2.21 Using the SD Memory Card..................................................................................................................... 2.21 About the SD Memory Card........................................................................................................... 2.21 Inserting and Removing the SD Memory Card.............................................................................. 2.23 Preparing the SD Memory Card..................................................................................................... 2.23 Operator’s Manual ECG-1150

2.1

2

2. PREPARATION

Selecting a Suitable Location Select a suitable examination location according to the following WARNINGS, CAUTIONS and NOTES and refer to “GENERAL HANDLING PRECAUTIONS”.

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 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.

CAUTION The electrocardiograph should not share the power line with any instrument which consumes a lot of power, such as an X-ray instrument, because it may cause artifact.

CAUTION Make sure that there is enough space between the electrocardiograph and the wall for adequate ventilation. Leave more than 5 cm of space between the wall and electrocardiograph so that the operating temperature does not exceed 40°C (104°F). Otherwise the internal temperature of the electrocardiograph rises, which leads to inaccurate operation and shortens the electrocardiograph life.


2.2

CAUTION • Do not install the electrocardiograph near a power line, dynamo or motor which has electromagnetic induction. • Do not install the electrocardiograph near an electrosurgical unit or RF therapeutic equipment. • Select a room without excessive noise, vibration, sunlight, high humidity or water splashes. • Make sure that there is no interference from a mobile phone. • Avoid locations where the electrocardiograph may receive strong electromagnetic interference such as radio or TV stations, mobile phones or mobile two-way radios. • Do not install the electrocardiograph where it will be exposed to water or chemical solutions. Avoid direct sprinkling, spray or moist air from a nebulizer or humidifier. These cause malfunction and shorten the life of the electrocardiograph.


2. PREPARATION

CAUTION

CAUTION

When installing the electrocardiograph, take care not to pinch your finger under the electrocardiograph.

Do not use the electrocardiograph with its side panel down. Failure to follow this instruction may cause the electrocardiograph to fall over or cause battery liquid leakage.

NOTE • Install the electrocardiograph where the screen can be seen clearly and does not reflect light. • Do not place blankets or cloth over the electrocardiograph. • Do not install the electrocardiograph in a dusty area


2.3

2

2. PREPARATION

Mounting the Electrocardiograph on the Optional Cart


Mounting the Electrocardiograph on the Cart

E

D

A B

C

B C A E

D

1. Attach the set pins to the holes E (KD-104E) or A (KD-105D/105E) on the top cover of the cart.

Attach the set pins to these holes. B

D C

Use the two set pins and two screws (option: contact your Nihon Kohden representative) to mount the electrocardiograph on the cart.

2. Mount the electrocardiograph by aligning the holes on the rear panel over the set pins.

A

D C

B

For details, refer to the installation guide of the cart.

A

Options for the Cart KD-104E Cart DI-009D paper tray DI-010D storage rack DI-007D magnetic card reader holder DI-008D bar code reader holder — —

KD-105D/105E Cart DI-011D paper rack DI-013D middle shelf*1 DI-014D drawer assembly*1*2 DI-012D magnetic card reader holder*2 — DI-015D cart tray assembly DI-016D roll paper holder*1

*1 A DI-013D middle shelf, DI-014D drawer and DI-016D roll paper holder cannot be attached together on the KD-105D/105E cart. 2 * It is possible to attach a DI-014D drawer and DI-012D magnetic card reader holder together on the KD-105D/105E cart, but the card reader holder interferes with putting items in and taking items out of the drawer. KH-100D patient cable hanger You can attach the KH-100D patient cable hanger to the cart and put the cables and hook limb leads on the hanger. The hanger prevents the cables from getting tangled or the limb leads from getting in the way. 2.4


2. PREPARATION

Connecting the Power Cord and Grounding the 2

Electrocardiograph Connecting the Power Cord WARNING Only use the provided power cord. When the provided power cord cannot be used or when equipotential grounding is doubtful (such as in a facility with poor grounding), operate the electrocardiograph on battery power. Otherwise, the patient and operator may receive electrical shock or injury. NOTE • Make sure that there is always a battery pack inside the electrocardiograph in case the power cord is disconnected or there is a power failure. • When there is no battery inside the electrocardiograph, there may be noise on the waveform or the electrocardiograph may reset and lose measurement data. Connect the provided power cord to the AC power cord socket on the right side panel of the electrocardiograph and plug the cord into a 3-prong AC socket.

Grounding the Electrocardiograph WARNING When several medical instruments are used together, ground all instruments to the same one-point ground. Any potential difference between instruments may cause electrical shock to the patient and operator.

When more than one electrical instrument is used, there may be electrical potential difference between the instruments. The potential difference between the instruments may cause current to flow to the patient connected to the instruments, resulting in electrical shock (micro shock). Always perform equipotential grounding when required. It is often required in the operating room, ICU room, CCU room, cardiac catheterization room and Xray room. Consult with a biomedical engineer to determine if it is required. When equipotential grounding is required to ensure patient safety, use the grounding wire of the AC power cord.


2.5

2. PREPARATION

Cutting Off the Power Supply to the Electrocardiograph To cut off the power supply to the electrocardiograph, disconnect the power cord of the electrocardiograph from the AC socket. When installing the electrocardiograph, position the electrocardiograph so that it is easy to disconnect the power cord from the AC socket.

2.6


2. PREPARATION

Operating on Battery 2 The electrocardiograph can operate on battery power with the optional SB-901D battery pack. When a battery is inserted, the electrocardiograph automatically switches to battery power if the power cord is disconnected or there is a sudden power failure.

Battery Handling WARNING

WARNING

Do not do the following to the battery pack. It may cause leakage, overheating, explosion and fire. • Short-circuit the + and – terminals on the battery pack. • Put the battery pack into fire or heat the battery pack. • Disassemble or modify the battery pack. • Give strong impact to or deform the battery pack. • Use the battery pack on unspecified instruments. • Charge the battery pack on unspecified instruments. • Install the battery pack with the wrong polarity. • Leave the battery pack in the reach of patients.

If the liquid inside the battery contacts the eyes, mouth or skin, do not rub the eyes, mouth or skin. Wash with clean water and see a physician immediately.

WARNING Only use the SB-901D battery pack.

CAUTION

WARNING The following may cause overheating and leakage of the battery pack. • Leaving the battery pack unused for a long period (more than a year) • Immersing the battery pack in water or sea water or getting it wet

WARNING Check the direction of the connector when connecting the battery cable. Do not force the battery cable into the battery connector.

CAUTION

Do not bend or pull the connector of the battery pack cable with strong force. This may damage the battery cable or battery cable connector.

If the battery operation time is less than 15 minutes, the battery pack may be deteriorated. Do not charge a deteriorated battery pack. Charging a deteriorated battery pack may cause the electrocardiograph to fail to operate in both battery and AC power.

NOTE • The operation time with the fully charged battery pack is 90 minutes or more when the surrounding temperature is 25°C (77°F). If the surrounding temperature is more than 25°C (77°F) or depending on waveform quality, the operation time may be less.


2.7

2. PREPARATION • The lifetime of the battery pack is about one year. When operating the electrocardiograph with the battery pack, check the date when the battery pack was last replaced on the start date label attached to the electrocardiograph. • To keep the battery pack fully charged, always keep the power cord connected to the AC socket even when the electrocardiograph is not used. Battery Replacement

CAUTION

CAUTION

The battery pack must be replaced by qualified service personnel.

Before connecting or disconnecting instruments, make sure that each instrument is turned off and the power cord is disconnected from the AC socket. Otherwise, the patient or operator may receive electrical shock or injury.

Charging

CAUTION

CAUTION

If the battery operation time is less than 15 minutes, the battery pack may be deteriorated. Do not charge a deteriorated battery pack. Charging a deteriorated battery pack may cause the electrocardiograph to fail to operate in both battery and AC power.

Charge the battery pack at surrounding temperatures of 5 to 40°C (41 to 104°F). If the battery is charged below 5°C or over 40°C, the battery may leak or heat up. This may damage the battery.

NOTE • Before using a new battery pack, charge it with the ECG-1150 electrocardiograph. • The charging time of the battery pack is less than 10 hours when the surface temperature of the battery pack is between 10 and 35°C (50 and 95°F). The charging time depends on the surface temperature of the battery pack. When the surface temperature of the battery pack is below 10 or over 35°C (50 to 95°F), it may take longer to charge the battery. • During charging, the battery pack may heat up. Do not put anything on or cover the electrocardiograph.

2.8


2. PREPARATION Storage

WARNING

2

Do not leave the battery pack unused for more than a year. The battery may leak.

CAUTION Do not use or leave the battery pack in direct sunlight or high temperatures such as in a car in hot weather or in front of a stove. It may cause leakage of the battery pack and degrade the performance and lifetime of the battery pack.

CAUTION • Remove the battery pack from the electrocardiograph when it is not used more than six months. The battery may leak out and rust. • When the battery pack is not used more than 90 days, store the battery pack at temperatures between –20 to +30°C (–4 to +86°F) in a dry place to prevent it from rusting and leakage. • If the surrounding temperature is over 30°C (86°F), charge it every three months because it self-discharges quickly. • When the battery pack is stored more than one month, charge it before use because the battery pack may have self-discharged. • Replace the battery pack with a new one every year to assure maximum performance from the electrocardiograph.

When the battery pack is stored for a long time, it may become inactivated and cannot be fully charged. The battery charge may be recovered by discharging and charging the battery several times. Disposing

CAUTION SB-901D battery pack is NiMH (Nickel-Metal Hydride). Before disposing of the battery pack, check with your local solid waste officials for details in your area for recycling options or proper disposal. The battery is recyclable. At the end of its useful life, under various state and local laws, it may be illegal to dispose of this battery into the municipal waste stream. NOTE When disposing of the electrocardiograph, remove the battery pack and attach tape over the battery cable. Otherwise, the battery may explode at waste disposable services.


2.9

2. PREPARATION

Inserting the Battery Pack WARNING

WARNING

Do not touch the patient while touching any metal part of non-medical electrical equipment or an exposed part when a connector or cover is removed. Failure to follow this warning may cause electrical shock or injury to the patient.

Only use the SB-901D battery pack.

The electrocardiograph is shipped from the factory with no battery pack installed. Follow the procedure below to insert a battery pack into the electrocardiograph before use. 1. Remove the M3 binding head screw from the battery cover and pull off the battery cover.

2. Connect the battery cable to the battery pack connector. 3. Insert the battery pack into the battery compartment.

4. Attach the battery cover and secure it with the screw.

2.10


2. PREPARATION

Removing the Battery Pack Remove the battery pack while pressing the lock under the battery cable.

2

NOTE Do not pull the cable with strong force. This may damage the connector.

Charging the Battery The battery can be charged when AC power is supplied to the electrocardiograph and the power is turned off. You cannot charge the battery when the power is turned on. The battery charge time is at least 10 hours. A new fully charged battery provides at least 90 minutes continuous recording. To charge the battery When the electrocardiograph is not used, connect the electrocardiograph to a wall AC socket to charge the battery. The AC power lamp and battery charge lamp light when the electrocardiograph battery is charging. 1. Press the POWER key to turn the power off. 2. Connect the electrocardiograph to a wall AC socket. The AC power lamp and battery charge lamp light. Battery charge lamp Lit: Charging OFF: Fully charged NOTE • When you operate the electrocardiograph on battery power, run down the battery as much as possible before recharging. If you frequently charge the battery after it has only been used for a short time, it may shorten the life of the battery. • After charging is complete, the battery charge lamp lights about every half hour to one hour. This is because a small current is supplied to the battery (supplementary recharging) to prevent self-discharging of the battery. Keep the power cord plugged into the AC socket when the electrocardiograph is not used. • Right after the battery is fully charged, and during battery operation, the battery operation lamp may light in orange when the surrounding temperature is low or when printing ECG waveforms. • When operation time is reduced to half, even if the battery pack is fully charged, the battery life may be expired. Replace the battery with a new one. • When the battery charge lamp does not light every half hour to one hour, even after a ten-hour recharging, the battery life may be expired. Replace the battery with a new one. For battery operation time, refer to “AC and Battery Operation” in Section 1. Operator’s Manual ECG-1150

2.11

2. PREPARATION

Setting the Recording Paper Handling the Recording Paper Recording Paper

CAUTION • Only use the Nihon Kohden specified 63 mm recording paper. When a narrower recording paper is used and the paper detection circuit cannot detect it, the thermal head may be activated. The thermal head may be damaged where there is no recording paper and the rubber paper feed roller may get burned. • If unspecified recording paper is used, it might not print properly or send multiple pages.

Model:

RQS63-3

Type: Length: Paper marks: Grid: Paper location:

Roll 30 m No No In the electrocardiograph

Storage

CAUTION Prolonged storage under conditions such as high temperatures, excessive humidity, direct sunlight, and fluorescent light causes fading of the colored surface. Avoid high temperatures exceeding 50°C (122°F) and excessive humidity. Store the recording paper in a cool, dry and dark place if possible.

2.12


2. PREPARATION Usage

CAUTION

2

• Organic solvents and plastics may develop color on the white surface or cause the recording paper to fade. Examples of color-developing materials containing organic solvents: Adhesives, paste, felt-tip pens, and semi-dry diazo paper. Examples of color-fading materials made of soft vinyl chloride: Document cases, albums, and desk pads including. Examples of color-fading materials containing plastics: Erasers, adhesive tapes, and some fluorescent pens. • The paper cutter in the recording paper container is sharp. When setting the recording paper, be careful not to cut your finger. Set the recording paper as specified. • When pasting the recording paper, use paste with a starch base, PVA base, arabic gum base paste, CMC base synthetic paste, or paper bond. • Do not apply high pressure to the recording paper. Rubbing or scratching the surface with a hard object discolors it. • Clean the thermal head with the thermal head cleaner after every 100 m printing. A dirty thermal head degrades printing quality. • Do not use recording paper which is contaminated with ECG electrolyte cream (cardioCream) or saline solution because the recording paper will fade by the chloride and the contaminated thermal head may cause missing dots. If the thermal head gets contaminated, clean it with the thermal head cleaner pen. • Do not touch the thermal head with your fingers. If accidentally touched, clean the thermal head with the thermal head cleaner pen. • Follow the procedure to set the recording paper. Otherwise, the recording paper might not feed normally or the feeding motor may stop operation.

Replacement

CAUTION Do not set the recording paper right after recording because the thermal head is still hot.


2.13

2. PREPARATION

Setting the Recording Paper 1. Press down the recorder cover release button to open the recorder.

Recorder cover release button 2. Turn over the recorder cover. 3. Set the recording paper in the recorder cover by spreading the paper guides. Paper guide

4. Pull out the recording paper and align it with the recorder cover.

5. Attach the recorder cover to the recorder while holding the paper.

2.14


2. PREPARATION 6. Close the recorder cover by pressing the center of the cover.

NOTE When recording paper is not aligned with the paper guide, skewing may occur.

Feeding the Paper You can feed the paper by pressing the FEED/MARK key anytime before or after recording.


2.15

2

2. PREPARATION

Connecting the Patient Cable

WARNING Only use the BJ-901D/BJ-902D/BJ-903D/BJ-961D or BA-901D/BA903D patient cables when using with a defibrillator. When the specified patient cable is connected, the electrocardiograph is type CF defibrillation-proof compliance. 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.

1. Connect the patient cable to the patient cable connector on the right side panel of the electrocardiograph.

2. Secure the connector to the electrocardiograph with the screws on the connector. NOTE Do not lift the electrocardiograph while holding the patient cable and do not bend or pull the patient cable strongly. This may break the cable.

2.16


2. PREPARATION

Turning the Power On or Off 2 WARNING Only use the provided power cord. When the provided power cord cannot be used or when equipotential grounding is doubtful (such as in a facility with poor grounding), operate the electrocardiograph on battery power. Otherwise, the patient and operator may receive electrical shock or injury.

Turning the Power On Before turning the power on, check the following items. If there is any damage or the electrocardiograph is suspected to be faulty as a result of checking, attach an “Unusable” or “Repair request” label to the electrocardiograph and contact your Nihon Kohden representative. Check Items Before Turning the Power On Overview: • Electrocardiograph is not dirty, damaged or in contact with liquid • No peeling or tear in the operation panel • No key or button is broken • Power cord is not damaged • Electrodes are clean and not damaged • Cable hanger is not damaged • Paper recorder is not damaged • Battery is installed Connection and setting: • Power cord is securely connected • Electrocardiograph is securely connected to an external instrument • Patient cable is securely connected to the electrocardiograph • Recording paper is properly set • Battery is fully charged Accessories: • Enough electrolyte cream • Enough recording paper • Enough disinfected or sterilized dry electrodes • Patient cable is not frayed or damaged • No crack in the rubber of suction electrodes • String of fast clip is strong enough • New and used electrodes are not used together


2.17

2. PREPARATION Lit

Turning the Power On • When operating on battery power After installing the fully charged battery pack, press the POWER key on the operation panel to turn the power on. The POWER lamp and battery operation lamp light. • When operating on AC power After grounding and connecting the power cord to a wall AC socket, press the POWER key on the operation panel to turn the power on. The POWER lamp and AC power lamp light.

Lit After turning the power on, check the following items. Check Items After Turning the Power On • AC power lamp or battery power lamp lights normally • LCD backlight lights • No fire, smoke or smell • No electrical shock when touching the electrocardiograph • Electrocardiograph is not too hot • Electrocardiograph does not affect surrounding equipment • Screen display is correct (brightness, contrast, no distortion, normal color, etc.) • All operation indicators lights • All keys on the operation panel operate correctly • All settings are correct • Calibration waveform is properly displayed and recorded • Amplifier of calibration waveform is correct • No noise on the calibration waveform • No error messages or malfunction during operation • Printing is correct (paper feeding without skewing or catching, no jamming, printing darkness, no faded or missing dots, date and time) • External instrument operates correctly • ECG data files can be saved correctly When the electrocardiograph is used for the first time, set the followings. Refer to Section 3 “Changing Settings Before Measurement”. Wave settings: AC filter System settings: Date and time, Date display format, Time display format

2.18


2. PREPARATION

Changing the Date and Time The date and time on the printing result is part of important information for the medical record. To change the date and time setting, refer to “Changing the Date and Time” in Section 3. NOTE If the date and time printed on the recording is not the current date and time, the lithium battery may be burned. Contact your Nihon Kohden representative.

Turning the Power Off NOTE The power cannot be turned off while processing ECG data file. Turn the power off after processing is complete. Press the POWER key on the operation panel for one second to turn the power off. The screen becomes dark and the POWER lamp on the operation panel turns off.


2.19

2

2. PREPARATION

Adjusting the Screen Brightness You can adjust the screen brightness. 1. Press the MODE key. The Main Menu screen is displayed.

2. Press “9” to select “Screen Brightness”. The Brightness screen is displayed.

3. Adjust the brightness with

or

If the screen is too dim, press the press the function key.

function key. function key. If the screen is too bright,

4. Press the OK function key to close the Brightness screen. 5. Press the “1” or “2” key to return to the ECG recording screen.

2.20


2. PREPARATION

Preparing for Data Management 2 About the Media The electrocardiograph can save the acquired ECG waveforms, patient information and analysis result as a file in the internal memory or SD memory card (hereafter referred to as “media”). Internal Memory Saves up to 40 files in the memory regardless of the data compression type. SD Memory Card QM-001D/064D/064DE SD memory card or equivalents. The QM-001D/064D/064DE SD memory card saves up to 780 files (type 1, normal) or 3000 files (type 2, compressed). Refer to Section 7 “Data Management”.

CAUTION Only use a Nihon Kohden specified SD memory card. Otherwise, the card might not operate. NOTE The electrocardiograph can only recognize 64 MB of data on the SD memory card even if the SD memory card is larger than 64 MB.

Using the Internal Memory 1. Set “Media” to “Internal memory” on the File Processing Section of the Main Setup screen. Refer to “List of Settings - Main Setup Screen - File Processing” in Section 3. 2. Format the internal memory. Refer to “Formatting the Media” in Section 7.

Using the SD Memory Card About the SD Memory Card Refer to the SD memory card manual and the following precautions for operation and cautions. To format an SD memory card, refer to “Formatting the Media” in Section 7.

CAUTION Only use a Nihon Kohden specified SD memory card. Otherwise, the card might not operate.


2.21

2. PREPARATION

CAUTION Do not leave the SD memory card near patients or in reach of children.

Recommended SD Memory Card QM-064DE (for Europe) or QM-001D/064D (for other countries) Handling

CAUTION

Example: QM-064D SD memory card

• Never disassemble or modify the SD memory card. • Do not bend or give a strong impact to the SD memory card. • Do not handle the SD memory card while smoking or eating. Do not get the SD memory card wet. • Do not touch any metal part of the SD memory card. • Do not peel off the label or sticker on the SD memory card or put other label or sticker on the SD memory card. • Only use the SD memory card in the specified instrument. • Do not scratch the insertion part of the SD memory card. The electrocardiograph might not operate when the dust gets into the insertion part. • Put the SD memory card in the case when the SD memory card is removed from the electrocardiograph. Store it where patients cannot accidently swallow the SD memory card. • Do not expose the SD memory card to direct sunlight or leave in a high temperature and high humidity. Operating Environment Temperature: –25 to +85°C (–13 to +185°F) Humidity: 25 to 95% RH (noncondensing) Storage Environment Temperature: –40°C to +85°C (–40 to +185°F) Humidity: 25 to 95% RH • Do not store the SD memory card in a corrosive gas environment.

Operation

CAUTION • Only format or write data to the SD memory card in the specified instrument. Otherwise, the SD memory card may become unusable. • Do not remove the SD memory card or turn the power off while formatting or data is being written to or read from the SD memory card. This may damage the SD memory card or saved data.

2.22


2. PREPARATION Inserting and Removing the SD Memory Card

CAUTION

2

• Insert only a Nihon Kohden specified SD memory card in the SD card slot. • Insert or remove the SD memory card straight into or out of the SD card slot. Otherwise, the SD memory card and electrocardiograph may get damaged. • Make sure that the electrocardiograph power is turned off, when inserting or removing an SD memory card. Otherwise, the data in SD memory card may get damaged and operation of the electrocardiograph may become unstable.

To insert the SD memory card: 1. Turn the electrocardiograph power off. 2. Insert the SD memory card straight into the SD card slot with the label side up until it clicks. To remove the SD memory card: 1. Turn the electrocardiograph power off. 2. Press in the edge of SD memory card. 3. Pull the card out straight from the SD card slot.

Preparing the SD Memory Card 1. Insert the SD memory card into the SD card slot on the right side panel of the electrocardiograph. Refer to the above “Inserting and Removing the SD Memory Card” section. 2. Set “Media” to “SD card” on the File Processing of the Main Setup screen. Refer to “List of Settings - Main Setup Screen - File Processing” in Section 3. 3. Format the SD memory card. Refer to “Formatting the Media” in Section 7.


2.23

Section 3 Changing Settings Before Measurement

3

System Setup Screen and Main Setup Screen.................................................................................................... 3.2 List of Settings...................................................................................................................................................... 3.3 System Setup Screen................................................................................................................................. 3.3 Patient Information........................................................................................................................... 3.3 Wave Settings.................................................................................................................................. 3.3 Recording Settings........................................................................................................................... 3.4 Periodic Recording Settings............................................................................................................. 3.5 System Settings............................................................................................................................... 3.6 Main Setup Screen..................................................................................................................................... 3.7 Wave Settings.................................................................................................................................. 3.7 File Processing................................................................................................................................. 3.7 Recording Settings........................................................................................................................... 3.7 Changing the System Setup Settings................................................................................................................... 3.9 Displaying the System Setup Screen and Changing the Settings.............................................................. 3.9 Changing the Date and Time................................................................................................................... 3.11 Entering the Hospital Name..................................................................................................................... 3.12 Changing the Main Setup Settings..................................................................................................................... 3.14 Saving the System Setup and Main Setup Settings........................................................................................... 3.16 Loading the System Setup and Main Setup Settings......................................................................................... 3.18 Printing the List of System Setup and Main Setup Settings............................................................................... 3.20


3.1

3. CHANGING SETTINGS BEFORE MEASUREMENT

System Setup Screen and Main Setup Screen This section explains how to change settings, save settings in an SD memory card, load settings from an SD memory card and print the list of system settings. We recommend saving and printing the settings immediately after installation. There are two setup screens, System Setup screen and Main Setup screen. System Setup screen settings are rarely changed. Main Setup screen settings are frequently changed. You can change settings without turning the power off. In the System Setup screen, you can change the following settings. • Patient information • Wave settings • Recording settings - Auto recording - Report print out - Analysis format and settings • Periodic recording settings • System settings • Save/Load/Print system settings In the Main Setup screen, you can change the following settings. • Wave settings • File processing • Recording settings - Recorder - Manual recording - Auto recording - Analysis format and settings - Rhythm recording

3.2



List of Settings System Setup Screen

3 The factory default settings are underlined. Patient Information

Item ID Sex Default sex Age

Default age group

Data auto delete

Description Select “On” to enable ID entry (up to 12 numeric characters) when recording starts. Select “On” to display sex on the Patient Information screen. Select the default sex when the power is turned on. Select whether to display the age on the Patient Information screen. When displaying age, select whether to display actual age or age group.

Settings On Off On Off M F Blank Age Age group Off

When “Age group” is selected, the Patient Information screen cannot be displayed, only sex and age group can be entered for the patient information using the keys on the operation panel. Select the default age group when the power is turned 3 - 5 on. This setting is only available when “Age or birth 6-9 date” is set to “Age group”. 10 - 14 15 - 34 35 + Select “Delete all” to clear the previous patient data Delete all when the ID is changed. Off

Wave Settings Item Baseline drift suppression

Description Baseline drift suppression prevents the baseline from drifting by locking it into one position at the start of recording.

Settings Strong Weak Off

CAUTION

When baseline drift suppression is set to “Strong”, distortion may occur in the ST segment with a decrease of heart rate when heart rate is less than 50. For bradycardia, set this item to “Weak”. The “Weak” setting has characteristics conforming to the AHA recommendations. AC filter


Set this to match your AC power line frequency.

50 Hz 60 Hz Off

3.3

3. CHANGING SETTINGS BEFORE MEASUREMENT Recording Settings Auto Recording Item Auto start

Description Select “On” to automatically start recording.

Settings On Off

Report Print Out Item Auto mode of Resting ECG recording Rhythm recording

Description Select “On” to print ECG and report in auto mode of the resting ECG recording. Select “On” to print ECG in rhythm recording.

Periodic recording

Select “On” to print ECG and report in periodic recording.

Settings On Off On Off On Off

Analysis Format and Settings Item Analysis

Minnesota

Description Select the analysis mode. When “screening” is selected, some ST-T related findings are not obtained. When “Advanced” is selected, more findings than “Standard” are obtained. For details, refer to the ECAPS 12C ECG Interpretation Program User’s Guide and Upgrade Information. NOTE The data acquired with “Advanced” setting might not be used in external systems. Select whether to print the Minnesota code.

Measurement/analysis selection

Select whether to print the measurement values and analysis result with the ECG waveforms.

QTc calculation method

Select a method to calculate QTc.

Settings Standard Standard (screening) Advanced Advanced (screening)

Minnesota Off Measurement + analysis Measurement only None ECAPS Bazett

QT interval varies according to the heart rate. QTc interval is a corrected value based on a heart rate of 60 bpm. ECAPS: QTc interval (ms) = QT interval (ms) +

(1000 − R-R interval (ms)) 7

bazett: QTc interval (ms) =

QT interval (ms) R-R interval (s)

3.4


3. CHANGING SETTINGS BEFORE MEASUREMENT Periodic Recording Settings Item

Description Select the starting lead group.

Starting leads Periodic recording type Fixed recording time

30 s 1 min 2 min 3 min 4 min 5 min 6 min 7 min 8 min 9 min 10 min 11 min 12 min 13 min 14 min 15 min

Interval (min) Interval recording repetitions Auto gain output Additional slow speed recording


Settings Limb Chest Select the ECG waveform acquisition interval. Fixed time Interval Off Select “On” to acquire the ECG waveform after the On specified time when “Periodic recording type” is set to Off “Fixed time”. On Off On Off On Off On Off On Off On Off On Off On Off On Off On Off On Off On Off On Off On Off On Off Select the interval when “Periodic recording type” is 1 to 60 (3) set to “Interval”. Select the number of times to acquire ECG waveform. 1 to 999 (10) Select “On” to automatically change the waveform On amplitude and position during periodic recording. Off Select “On” to slow paper speed until the next periodic On recording starts. Off

3

3.5

3. CHANGING SETTINGS BEFORE MEASUREMENT System Settings Sync sound

Item

Description Select QRS synchronized sound or stylus on paper scratching sound.

QRS sync sound volume

Select the QRS sync sound volume.

Notification sound volume

Select the notification sound volume.

Settings QRS sync sound Pen sound Off 1 (min) 2 3 4 (max) 0 (Off) 1 2 3 4 (max)

CAUTION At “0”, there is no sound. Chime volume

Select the chime volume.

Date and time

Set the date and time.

Date display format

Select the date display format.

Time display format

Select the time display and printing format.

Hospital

Enter the hospital name. It is printed in the “Exam.:” column. Select the language for display and recording.

Language

Backlight auto off Auto power off

3.6

NOTE • When you install a local language in the electrocardiograph, check the screen descriptions and printed ECG finding list before use. You can compare the screen descriptions with the text that your Nihon Kohden representative provides. You can compare the ECG finding list with the User’s Guide “ECAPS 12C ECG Interpretation Program”. If there is any missing or incorrect translation, contact your Nihon Kohden representative to correct it. • When changing the language to or from Korean, the entered hospital name is deleted. • When changing the language to or from Korean, the electrocardiograph must be restarted to enter the hospital name. Select “On” to automatically turn off the backlight when the electrocardiograph is not operated for 3 minutes. Select “On” to automatically turn off the electrocardiograph power when it is not operated for 3 minutes in battery operation.

0 (Off) 1 2 3 4 (max) Year, Month, Day, Hour and Minute yyyy/mm/dd yyyy–mmm–dd mmm–dd–yyyy dd–mmm–yyyy 12 hour day 24 hour day Up to 40 alphanumeric characters English Korean Local language

On Off On Off



Main Setup Screen Wave Settings Item High cut filter

Description Select the high cut filter frequency.

EMG suppression frequency

Select the EMG filter frequency.

Default EMG suppression setting Select “On” to turn on the EMG filter when the power is on.

Settings 75 Hz 100 Hz 150 Hz 25 Hz 35 Hz On Off

3

CAUTION

Take care when judging the ECG recording because the EMG filter may cause distortion of P-waves and QRS-waves depending on the waveform shape. Lead mode selection

Select the ECG lead recording order.

Standard 12 leads Cabrera leads

File Processing Item After analysis result recording Media Data compression type File auto delete

Description Select what to do with ECG data files after analysis result recording. Select the media to save ECG data files. Select the file format to save ECG data files. Type 1 is normal format and Type 2 is compressed format. Select “On” to automatically delete the oldest file when the media is full.

Settings Save Off SD card Internal memory Type 1 Type 2 On Off

Recording Settings Recorder Item High speed printing Default paper speed

Description Select “On” to print the recording results at high speed. The recording time is reduced by half. Select the initial paper speed when the power is turned on.

Settings On Off 25 mm/s 50 mm/s

Manual Recording Item 12 lead recording channels


Description Select the 12 lead recording channels.

Settings 3 ch 1 ch 1 ch + rhythm

3.7

3. CHANGING SETTINGS BEFORE MEASUREMENT Auto Recording Item Auto gain output

12 lead recording channels Time (s) Extended recording

Description Settings Select the auto gain and auto position control function. Auto gain + setting gain Auto gain Setting gain + auto gain Setting gain Select the 12 lead recording channels. 1 ch 3 ch Average + rhythm Select the total recording time when “Change 10 to 24 sec (10) sequence” is set to “Time”. On: rhythm (full page): On: rhythm (full page) When an arrhythmia is detected during automatic On: sequence (full page) recording, the rhythm recording starts after automatic Off recording ends. The format is set in “Rhythm Recording” in “Recording Settings” in the User Setup screen. On: sequence (full page): When the fluctuation of 20% of R-R interval is detected during automatic recording, the recording of the lead group is extended. The extend recording time is set in the “Mark” or “Time”.

Analysis Format and Settings Item Result printing format

Description Select analysis result recording printing format.

Include findings criteria

Select “On” to print the criteria for the finding.

Pacing detection sensitivity

Select the pacing detection sensitivity. If noise is incorrectly detected as a pacing pulse, select “Low”.

Settings Result only Result + average On Off High Low

Rhythm Recording Item Rhythm lead

3.8

Description Select the rhythm lead in rhythm lead recording.

Settings Standard 12 leads: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Cabrera leads: aVL, I, –aVR, II, aVF, III, V1, V2, V3, V4, V5, V6



Changing the System Setup Settings Displaying the System Setup Screen and Changing the Settings

3

1. Press the POWER key to turn the power off. 2. Press the POWER key while pressing the FILTER key. The System Setup screen is displayed.

3. Press the screen.

or

function key to select the desired item on the Setup

4. Press the OK function key. The Setup screen for that item is displayed.


3.9


5. Press the

or

function key to select the desired item.

6. Press the OK function key. The Setup screen for that item is displayed. Steps 5 and 6 are not necessary for some items.

7. Press the

or


8. Press the Change function key. The selectable items are toggled. Select the desired setting.

For changing the date and time, refer to the next “Changing the Date and Time” section.

For entering the hospital name, refer to “Entering the Hospital Name” in this section.

Interval (m) and Interval recording repetitions of Periodic Recording Settings can be changed by 1 step by pressing the Change function key and by 10 steps by pressing the FILTER key.

9. Repeat steps 7 and 8 to change other settings. 10. Press the Back function key to return to the previous screen. The changed setting is saved. 3.10



If the screen has more than two pages, press the the screen.

or

function key to scroll

Turn the power off and on again to return to the Resting ECG recording screen.

Changing the Date and Time 1. Display the System Setup screen. Refer to the previous “Displaying the System Setup Screen and Changing the Settings” section. 2. Press the

or

function key to select System Settings.

3. Press the OK function key. The System Settings screen is displayed.

4. Select the Date and time with the


or

function key.

3.11

3

3. CHANGING SETTINGS BEFORE MEASUREMENT 5. Press the Edit function key. The Date and time setting window is displayed.

6. Enter the current date and time with the keyboard on the operation panel. The order of the date setting is always yyyy/mm/dd. 7. Press the OK function key. The changed setting is saved. 8. Press the Back function key to return to the previous screen.

Entering the Hospital Name 1. Display the System Setup screen. Refer to “Displaying the System Setup Screen and Changing the Settings” in this section. 2. Press the

or

function key to select System Settings.

3. Press the OK function key. The System Settings screen is displayed.

3.12


3. CHANGING SETTINGS BEFORE MEASUREMENT 4. Select Hospital with the

or

function key.

3

5. Press the Edit function key. The Hospital setting window is displayed. 6. Enter the hospital name. When the “Language” is set to “English” or “Local language” Enter the hospital name with the function keys.

• A-Z: Enters a character. The characters are toggled. • Shift: Changes the character type.

•

A-Z

a-z

Char (symbol)

0-9

: Moves the cursor to the next character.

When the “Language” is set to “Korean” Enter the hospital name with the character code. Refer to “Character Code List” in Section 10. 7. Press the START/STOP key. The changed setting is saved and the previous screen appears. Hospital name is printed in the “Exam:” column on the recording paper. Operator’s Manual ECG-1150

3.13


Changing the Main Setup Settings 1. Press the MODE key to display the Main Menu screen.

2. Press “8” to select “Main Setup”. The Main Setup screen is displayed.

3. Press the screen.

3.14

or

function key to select the desired item on the Main Setup


3. CHANGING SETTINGS BEFORE MEASUREMENT 4. Press the OK function key. The Setup screen for that item is displayed.

3

5. Press the

or


6. Press the OK function key. The Setup screen for that item is displayed. Steps 6 and 7 are not necessary for some items.

7. Press the

or


8. Press the Change function key. The selectable items are toggled. Select the desired setting. 9. Repeat steps 8 and 9 to change other settings. 10. Press the Back function key to return to the previous screen. The changed setting is saved. If the screen has more than two pages, press the the screen.

or

function key to scroll

Press the “1” or “2” key on the Main Menu screen to return to the ECG recording screen. Operator’s Manual ECG-1150

3.15


Saving the System Setup and Main Setup Settings You can save all settings on the System Setup screen and Main Setup screen to an SD memory card. 1. Insert the SD memory card into the SD card slot on the right side panel of the electrocardiograph before saving the system settings. 2. Display the System Setup screen. Refer to “Displaying the System Setup Screen and Changing the Settings” in this section. 3. Press the or function key to select Save/Load/Print System Settings. Save/Load/Print System Settings is on the second page.

3.16


3. CHANGING SETTINGS BEFORE MEASUREMENT 4. Press the OK function key. The Setup screen is displayed.

3

5. Select Save System Settings and press the OK function key. The “Saving system settings. Do not turn the power off” message appears and the system settings are saved.

6. Turn the power off and on again to return to the Resting ECG recording screen.


3.17


Loading the System Setup and Main Setup Settings You can load previously saved settings on the System Setup screen and Main Setup screen from an SD memory card. 1. Insert the SD memory card in the SD card slot on the right side panel of the electrocardiograph before loading the system settings. 2. Display the System Setup screen. Refer to “Displaying the System Setup Screen and Changing the Settings” in this section. 3. Press the or function key to select Save/Load/Print System Settings. Save/Load/Print System Settings is on the second page.

4. Press the OK function key. The Setup screen is displayed.

3.18



3

5. Select Load System Settings and press the OK function key. The “Loading system settings. Do not turn the power off” message appears.

6. The “Apply new system settings?” message appears. Press the OK function key. The new system settings are loaded.

Press the Cancel function key to cancel. The settings are not changed and previous screen appears.

7. Turn the power off and on again to return to the Resting ECG recording screen. Operator’s Manual ECG-1150

3.19


Printing the List of System Setup and Main Setup Settings 1. Display the System Setup screen. Refer to “Displaying the System Setup Screen and Changing the Settings” in this section. 2. Press the or function key to select Save/Load/Print System Settings. Save/Load/Print System Settings is on the second page.

3. Press the OK function key. The Setup screen is displayed.

3.20



3

4. Select Print System Settings and press the OK function key. The “Printing system settings. Do not turn the power off” message appears and printing starts.

To cancel printing, press the Cancel function key.

5. Turn the power off and on again to return to the Resting ECG recording screen.


3.21

Section 4 Attaching the Electrodes and Entering Patient Information Attaching the Electrodes....................................................................................................................................... 4.3 Attaching the Limb Electrodes.................................................................................................................... 4.3 Attaching the Chest Electrodes.................................................................................................................. 4.3 Patient Cable Tip Color Coding............................................................................................................................ 4.4 Lead Connection.................................................................................................................................................. 4.5 Standard 12 Leads and Cabrera Leads..................................................................................................... 4.5 IEC Standard.................................................................................................................................... 4.5 AHA Requirement............................................................................................................................ 4.5 Error Indication When the Electrode Is Not Attached Firmly................................................................................ 4.6 Screen Message........................................................................................................................................ 4.6 Indication on the Paper.............................................................................................................................. 4.7 Countermeasure........................................................................................................................................ 4.7 Electrode Detachment...................................................................................................................... 4.7 Large Polarization Voltage................................................................................................................ 4.7 Entering the Patient Information........................................................................................................................... 4.8 General....................................................................................................................................................... 4.8 Entering the Patient Information . .............................................................................................................. 4.9


4.1

4

4. ATTACHING THE ELECTRODES AND ENTERING PATIENT INFORMATION

WARNING Do not connect the tip of the electrode lead to anything other than an electrode. Connect all the tips to the corresponding electrodes and attach them to the patient. If unconnected tips or electrodes contact an item which is not equipotential grounded, the patient may receive electrical shock. Also, noise may superimpose on the ECG waveforms and measurement data may be incorrect.

CAUTION • Do not use new and old electrodes together, or re-usable and disposable electrodes together (such as clip electrodes, suction electrodes, and disposable electrodes). If different types are used together, it may cause a high polarization voltage and prevent displaying and recording of the ECG waveforms. • Always replace all the electrodes with new ones at the same time. • When using an ESU and defibrillator with the electrocardiograph, use silver chloride disposable electrodes. • Only use clean and undamaged electrodes with no scratches on the surface. Electrodes with a deteriorated surface may cause high contact impedance and distorted ECG waveforms. • Do not touch electrodes, lead tips or electrocardiograph connectors to any other ground or conductive object in the room, such as a metal bedpost.

4.2



Attaching the Electrodes Attaching the Limb Electrodes Attach four limb electrodes to muscular, not bony, areas on the extremities.

4

1. Clean the skin with a cotton moistened with alcohol to remove oil. 2. Apply a thin layer of electrolyte cream (cardioCream) on the cleaned electrode sites. R: Right arm L: Left arm RF: Right leg F: Left leg 3. Apply a small amount of electrolyte cream on the contact surface of the electrodes. 4. When limb electrodes are used Attach the limb electrodes to the cleaned skin site.

When the ECG clip-on electrodes are used Clip the electrode site with the ECG clip-on electrode.

Attaching the Chest Electrodes 1. Clean the skin with a cotton moistened with alcohol to remove oil. 2. Apply a thin layer of electrolyte cream (cardioCream) on the cleaned skin sites. 3. Attach the six electrodes to the cleaned skin site. Do not let the electrodes touch each other. 4. Apply a thin layer of cardioCream on the electrode surface. 5. Put the electrode on the site and squeeze the rubber ball to attach the electrode by suction. Standard 12 Lead ECG/Cabrera Lead ECG C1 (V1): Fourth intercostal space at the right border of the sternum C2 (V2): Fourth intercostal space at the left border of the sternum C3 (V3): Halfway between C2 (V2) and C4 (V4) C4 (V4): Fifth intercostal space on left midclavicular line C5 (V5): Left anterior axial line at the horizontal level of C4 (V4) C6 (V6): Left midaxillary line at the horizontal level of C4 (V4)


4.3


Patient Cable Tip Color Coding BJ-901D, BJ-961D (IEC standard, tip: 3 mm diameter) BJ-902D (IEC/DIN standard, tip: 4 mm diameter) BJ-903D (IEC/DIN standard, clip) Symbol in lead R L F N (RF) C1 C2 C3 C4 C5 C6

Color (tip, clip/lead) Red/Brown Yellow/Brown Green/Brown Black/Brown Red/White Yellow/White Green/White Brown/White Black/White Violet/White

BA-901D (AHA requirement, tip: 3 mm diameter) BA-903D (AHA requirement, clip) Symbol in lead RA LA RL LL V1 V2 V3 V4 V5 V6

4.4

Color (tip, clip/lead) White/Brown Black/Brown Green/Brown Red/Brown Red/White Yellow/White Green/White Blue/White Orange/White Violet/White



Lead Connection Standard 12 Leads and Cabrera Leads IEC Standard

4

AHA Requirement


4.5


Error Indication When the Electrode Is Not Attached Firmly Screen Message The electrocardiograph continuously checks electrode attachment status. When electrode detachment or large polarization voltage is detected, a message is displayed. Screen message Fail R, L, F Fail Limb Fail 1, 2, 3, 4, 5 or 6 Noise

Possible cause The indicated limb electrode is detached. • Two or more limb electrodes from the R, L or F electrode are detached. • The RF electrode is detached. • No electrode is attached to the patient. The indicated chest electrode is detached. Noise or artifact is detected.

NOTE • If a limb electrode is detached, the chest electrode detachment message is not displayed. Check the chest electrode attachment after removing the cause of the error message. • The ECG waveforms can be displayed and recorded if the message due to a large polarization voltage is displayed. If recording starts, the analysis result may be incorrect and the ECG waveforms cannot be saved. Remove the cause of the error message before starting measurement. • A flat baseline is recorded for leads with a detached electrode. • When using the electrocardiograph with an ESU, artifact from the ESU may be superimposed on the ECG waveforms.

4.6



Indication on the Paper During recording, the following line is recorded on the paper when an electrode detachment or artifact is detected.

4

Electrode detachment

Noise

Countermeasure Electrode Detachment Check for detached electrodes corresponding to the message and the electrode lead. Reattach the electrode and connect the electrode lead. Large Polarization Voltage If the message is still displayed after reattaching the electrode, it is probably due to a large polarization voltage. A large polarization voltage can have the following causes: • New and old electrodes, or re-usable and disposable electrodes are used together (such as clip electrodes, suction electrodes, and disposable electrodes). If different types are used together, it may cause a large polarization voltage and prevent displaying and recording of the ECG waveforms. • Improper skin preparation. Use a cotton moistened with alcohol to clean the skin where the electrode is attached and apply the electrolyte cream (cardioCream) on the clean skin site. Reattach the electrode. • After defibrillation, the ECG waveforms become unstable. Wait at least 5 seconds until the ECG waveforms are stable before recording the ECG waveforms. When the cause of the message cannot be found, the electrode lead may be faulty. If any abnormality is found, refer to “Troubleshooting” in Section 8 to take proper action. If there is any damage or the electrocardiograph is suspected to be faulty as a result of checking, attach an “Unusable” or “Repair request” label to the electrocardiograph and contact your Nihon Kohden representative.


4.7


Entering the Patient Information General You can enter the following patient information on the resting ECG recording screen. The available patient data can be selected in the Patient Information settings. Refer to Section 3 “Changing Settings Before Measurement”.

CAUTION When the patient sex and age is not entered, ECG analysis is performed with the patient as male and 35 years old. NOTE Add an ID to the patient information to prevent the ECG data from being mistaken for a different patient’s ECG data. Available patient data • ID: Up to 12 numeric characters • Gender: Male, female • Age: Up to 3 numeric characters • Age group: 3 to 5, 6 to 9, 10 to 14, 15 to 34, 35 ≤ When “Age group” is set for “Age or birth date” on the System Setup When “Age group” is set for “Age or birth date” on the System Setup screen, the Patient Information screen cannot be displayed and patient information cannot be entered. Only gender and age group can be entered using the number keys on the operation panel.

4.8



Entering the Patient Information NOTE If you change the ID, the Name and Age/Date of birth are deleted and Gender returns to the default setting. 1. Press the ID key. The cursor appears on the ID column.

4

2. Enter the patient ID with the following operation keys and press the START/ STOP (enter) key. The cursor moves to the gender column. Numeric

Key

Numeric

Key

0

COPY/CAL key

6

AGE key

1

F1 function key

7

GENDER key

2

F2 function key

8

FEED/MARK key

3

F3 function key

9

FILTER key

4

MODE key

—

F4 function key

5

RHYTHM key

Clear

AUTO/ MANUAL key

Enter

START/STOP key

3. Select the gender by pressing the GENDER key and press the START/STOP key. The cursor move to the age column. 4. • When “Age” is set to “Age” in the System setup. Enter the patient age with the operation keys. • When “Age” is set to “Age group” in the System setup. Select the age group by pressing the AGE key.


5. Press the ID key. The patient information is set and Resting ECG recording screen appears. 4.9

Section 5 Recording Resting ECG Waveforms 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............................................................................................................................................ 5.9 General....................................................................................................................................................... 5.9 Real Time Recording........................................................................................................................ 5.9 Review Recording............................................................................................................................ 5.9 Auto Gain and Auto Position............................................................................................................ 5.9 Preparation for Automatic Recording......................................................................................................... 5.9 System Setup................................................................................................................................. 5.10 Main Setup..................................................................................................................................... 5.10 Automatic Recording Procedure.............................................................................................................. 5.12 Extended Recording....................................................................................................................... 5.14 Saving the ECG Data File.............................................................................................................. 5.14 Printing Another Copy of the Recording Results...................................................................................... 5.15 Manual Recording.............................................................................................................................................. 5.16 General..................................................................................................................................................... 5.16 Preparation for Manual Recording............................................................................................................ 5.16 System Setup................................................................................................................................. 5.16 Main Setup..................................................................................................................................... 5.16 Manual Recording Procedure................................................................................................................... 5.17 Rhythm Recording.............................................................................................................................................. 5.19 General..................................................................................................................................................... 5.19 Rhythm Recording Procedure.................................................................................................................. 5.19 Recording Examples.......................................................................................................................................... 5.20 Auto Recording Examples........................................................................................................................ 5.20 Manual Recording Examples................................................................................................................... 5.21 Rhythm Recording Examples................................................................................................................... 5.21


5.1

5

5. RECORDING RESTING ECG WAVEFORMS

General You can record the resting ECG waveforms automatically or manually. When the power is turned on, automatic recording mode is the default selection. In automatic recording mode, ECG analysis is automatically performed. After ECG waveforms are recorded, the ECG analysis result is automatically printed (unless “Report print out” setting is set to Off on the System Setting screen). There are two automatic recording modes, real time and review recording mode. In review recording mode, you can verify the ECG waveform displayed on the screen before starting recording. This lets you confirm clear ECG recording and accurate ECG analysis. In real time recording mode, when fluctuation of 20% of R-R interval is detected, the electrocardiograph can automatically extend lead group recording for the preset interval. After recording, you can save the 12 lead ECG (including extended sequence recording) analysis result and patient information as an ECG data file in the media. You can make one or more copies of the recording results before the next recording starts. In manual recording mode, you can manually change the recording settings (paper speed, sensitivity, and EMG filter on/off) during recording. You can also annotate the ECG waveforms with an event mark by pressing the FEED/MARK key. Before or after automatic or manual ECG recording, you can record one minute of the rhythm lead. You can set the channel of the lead on the Rhythm Recording of the Recording Settings in the Main Setup screen. For recording settings and other settings, refer to Section 3 “Changing Settings Before Measurement”. Caution when the ECG waveform has artifact

CAUTION During recording, if large artifact appears on the ECG waveform, immediately stop the recording and remove the cause of the artifact. Refer to “Troubleshooting” in Section 8. Failure to follow this instruction causes overheating and damage to the electrocardiograph.

If the ECG recording is continued in this condition, the power unit in the electrocardiograph generates high frequency noise which causes the electrocardiograph to heat up. When the electrocardiograph heats up, a notification sound occurs and the START/STOP lamp blinks. The recording cannot be performed until the electrocardiograph cools down. 5.2



Flow of Resting ECG Waveform Recording Following is the basic procedure for recording resting ECG waveforms. 1. Turn the power on. Lamp


5

2. Select automatic or manual recording mode by pressing the AUTO/ MANUAL key. Lamp on: Automatic recording Lamp off: Manual recording

Automatic recording: i) Enter the patient information for ECG analysis. ii) Press the START/STOP key or F3 function key (review recording).

To print a copy of the recording results, press the COPY/CAL key.

When “After analysis result recording” on File Processing of the Main Setup screen is set to “Save”, after automatic recording, the analysis result and patient information are automatically saved as an ECG data file in a media.

Manual recording: i) Press the START/STOP key. ii) Press the function key to select the next lead group. iii) Repeat step ii) to record all lead groups. iv) Press the START/STOP key to stop recording.

Rhythm recording: Press the RHYTHM key. When one minute of ECG waveforms are acquired, rhythm lead recording starts automatically.

5.3


Notes for Accurate Measurement Before Starting the Recording 1. In order to acquire correct heart rate and accurate analysis result, confirm the following before pressing the START/STOP key. • Stable heart rate • No electrode detachment or noise message • The QRS sync mark on the screen blinks in synchronization with the QRS sound or pen sound. To generate the sound, refer to “System Settings” in Section 3. • No artifact in the pen sound. 2. Immediately after electrodes are attached, the ECG waveforms may be unstable because of polarization voltage. Before pressing the START/STOP key wait at least 10 seconds for stable ECG waveforms.

Detecting QRS Waves The electrocardiograph detects the QRS wave from leads II, V1 and V5. To assure QRS detection accuracy, take care to minimize superimposed artifact on these leads. Take care that QRS wave detection accuracy is not reduced by artifact superimposed on these leads. Also when the amplitude of these QRS waves is too small (less than 0.5 mV), the electrocardiograph cannot detect the QRS wave. NOTE If low amplitude QRS wave is displayed on the screen and the QRS sync mark does not blink, the electrocardiograph does not analyze the ECG waveform. The “CANNOT ANALYZE ECG” message is printed on the ECG analysis result.

Counting the Heart Rate The electrocardiograph counts the heart rate by averaging the latest five QRS waves and prints the heart rate together with the ECG waveforms.

Using the EMG/High-cut Filter When using the EMG filter, the quality of ECG recording may be reduced. However, the EMG filter and high-cut filter do not affect the ECG analysis.

5.4



ECG Analysis The electrocardiograph acquires 12 lead ECG waveforms simultaneously and analyzes the 10 to 24 seconds of ECG waveforms. The selected leads and interval of the waveforms are printed on the paper. The ECG analysis result is incorrect if artifact is superimposed on the notselected leads or interval. When an electrode detachment line or noise line is printed on the paper, artifact was superimposed on the ECG waveforms during acquisition. When any of these line is printed, record the ECG waveforms again to assure accurate ECG analysis, verifying that all ECG leads are free from artifact.


5.5

5


Resting ECG Recording Screen Displaying the Resting ECG Recording Screen 1. When the power is turned on, the Resting ECG recording screen appears. If another screen is displayed, press the MODE key to display the Main Menu screen.

2. Press “1” to select “Resting ECG”. The Resting ECG recording screen is displayed.

5.6



Explanation of the Resting ECG Recording Screen Standard 12 Leads Screen Heart rate Updated every beat.

Patient information display area For the default settings, refer to Section 3 “Changing Settings Before Measurement”. When the patient ID, gender and age are entered, they are displayed here. Refer to “Entering the Patient Information” in Section 4.

QRS sync mark Blinks in synchronization with the QRS wave.

5

Examination name

Electrode status display area Displays the error message for electrode detachment and noise.

CAL mark The height corresponds to 1 mV waveform amplitude.

Message and key function display area Displays the functions of the function keys and screen message.


Waveform display area Displays 2.8 seconds of the 12 lead ECG waveforms in 2 sequences of 6 channels each.

5.7

5. RECORDING RESTING ECG WAVEFORMS Cabrera Lead Screen Heart rate Updated every beat.

Patient information display area For the default settings, refer to Section 3 “Changing Settings Before Measurement”. When the patient ID, gender and age are entered, they are displayed here. Refer to “Entering the Patient Information” in Section 4.

QRS sync mark Blinks in synchronization with the QRS wave.

Examination name

Electrode status display area Displays the error message for electrode detachment and noise.

CAL mark The height corresponds to 1 mV waveform amplitude.

Message and key function display area Displays the functions of the function keys and screen message.

5.8

Waveform display area Displays 2.8 seconds of the 12 lead ECG waveforms in 2 sequences of 6 channels each.



Automatic Recording General The electrocardiograph automatically records the ECG waveforms and calibration waveforms by switching the lead groups in the settings selected in the Setup mode when the START/STOP key is pressed. There are two recording modes: Real Time Recording When you press the START/STOP key, the electrocardiograph starts recording real time ECG waveforms following the Auto Recording settings in the Setup mode. The ECG lead group is periodically switched. When “Auto start” is set to “On” on the Auto Recording of the System Setup screen and auto-start conditions are satisfied, real time recording automatically starts. Review Recording When the Resting ECG mode is selected, the electrocardiograph checks for electrode detachment. When 2 seconds pass with no electrode detachment, the electrocardiograph starts acquiring and saving the ECG waveforms. So you can check the acquired ECG waveforms before recording starts. When the F3 function key is pressed, the electrocardiograph starts recording the saved waveforms from 10 seconds before the F3 function key is pressed. Auto Gain and Auto Position The recording sensitivity and position are automatically adjusted so that the ECG waveforms of each channel do not overlap. However, waveforms may overlap where there is noise or change of waveform. During recording, if any ECG waveforms exceed the maximum recording width, the waveform amplitude is automatically reduced to 1/2 (up to 1/8) and the waveforms are repositioned so that the entire waveforms can be recorded on the recording paper. The auto gain waveform amplitude is based on the sensitivity setting before recording.

Preparation for Automatic Recording Change the following settings, if necessary. Refer to Section 3 “Changing Settings Before Measurement”. The factory default settings are underlined. To print out the current settings, refer to “Printing the List of System Setup and Main Setup Settings” in Section 3.


5.9

5

5. RECORDING RESTING ECG WAVEFORMS System Setup Wave Settings Baseline drift suppression (Strong, Weak, Off) Baseline drift suppression prevents the baseline from drifting by locking it into one position at the start of recording.

CAUTION When baseline drift suppression is set to “Strong”, distortion may occur in the ST segment with a decrease of heart rate when heart rate is less than 50. For bradycardia, set this item to “Weak”. The “Weak” setting has characteristics conforming to the AHA recommendations.

Recording Settings Auto Recording Auto start (On, Off) When “Auto start” is set to “On”, the real time recording is automatically started according to the format set on “12 lead recording channels” when all the following conditions are satisfied: • Automatic recording is not started. • No electrode detachment is detected for two seconds or more. • Five or more QRS waves are detected. • Artifact and high frequency noise are not detected. • The lead group is periodically switched. NOTE After recording, this function is available only when the electrodes are reattached to the same patient or attaching the electrodes for the next patient. Main Setup Wave Settings • High cut filter (75 Hz, 100 Hz, 150 Hz) This is active only when the EMG filter is turned off. • EMG suppression frequency (25 Hz, 35 Hz) EMG filter frequency. • Lead mode selection (Standard 12 leads, Cabrera leads) Standard 12 leads: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Cabrera leads: aVL, I, –aVR, II, aVF, III, V1, V2, V3, V4, V5, V6

CAUTION Take care when judging the ECG recording because the EMG filter may cause distortion of P-waves and QRS-waves depending on the waveform shape.

5.10


5. RECORDING RESTING ECG WAVEFORMS File Processing • After analysis result recording (Save, Off) Set whether to save the ECG files after analysis result recording. When you select “Save”, the ECG files are automatically saved in an SD memory card. • Media (SD card, Internal memory) Select the media to save the ECG data files. Recording Settings Recorder High speed printing (On (50 mm/s), Off (25 mm/s)) Applies to analysis result printing.

5

Auto Recording • Auto gain output (Auto gain + setting gain, Auto gain, Setting gain + auto gain, Setting gain) Select the auto gain and auto position control function. When “Auto gain + setting gain” or “Setting gain” is selected, the sensitivity can be changed by pressing the 10 mm/mV function key. 10 mm/mV

5 mm/mV

20 mm/mV

• 12 lead recording channels 1 ch (12 lead): 12 lead ECG waveforms are recorded in the order of lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6. 3 ch (12 lead): 12 lead ECG waveforms are recorded as 3 channels in 4 sequences. Average + rhythm: The averaged waveform for each lead and rhythm lead are recorded in 2 channels. The length of each sequence is 10 seconds (fixed). • Extended recording On: rhythm (full page): When an arrhythmia is detected during automatic recording, the rhythm recording starts after automatic recording ends. The format is set in “Rhythm Recording” in “Recording Settings” in the Main Setup screen. On: sequence (full page): When fluctuation of 20% of R-R interval is detected during automatic recording, the recording of the lead group is extended. The extend recording time is set in the “Time” setting. Off: Not recorded. Analysis Format and Settings (12 lead ECG only) • Result printing format (Result only, Result + average) Select “Result + average” when printing the average waveform for each lead with the ECG analysis result. • Include findings criteria (On, Off) Prints the criteria for the findings when this item is set to “On”. Operator’s Manual ECG-1150

5.11


Automatic Recording Procedure CAUTION • When “Auto start” is set to “On”, select the patient age group and sex before attaching the electrodes to the patient. After the electrodes are attached and the ECG waveform is stable, the recording automatically starts and the default settings of the patient age group and sex are used for ECG analysis. For ECG analysis details, refer to the User’s Guide “ECAPS 12C ECG Interpretation Program”. • When the “Do not turn the power off” message appears during saving the ECG data file, do not turn the power off. Otherwise, the data will be lost. • When “After analysis result recording” on the File Processing of the Main Setup screen is set to “Save”, check the remaining file capacity and delete unnecessary files before starting recording.

CAUTION When the patient sex and age is not entered, ECG analysis is performed with the patient as male and 35 years old.

1. Check the following before starting recording. • The patient is relaxed. • The electrodes (especially chest electrodes) are not in electrical contact with each other and they are properly attached and there is no artifact. 2. Check that the AUTO/MANUAL lamp is lit. If it is not lit, press the AUTO/ MANUAL key. 3. Enter the patient information. Refer to “Entering the Patient Information” in Section 4. 4. If necessary, press the FILTER key to turn the EMG filter on.

or

5.12

5. Select the real time or review recording mode by pressing the START/ STOP key (real time recording) or F3 function key (review recording). The electrocardiograph automatically records the ECG waveforms with switching the lead groups.



Auto Start When “Auto start” is set to “On” and all the following conditions are satisfied, the real time recording is automatically started. • Automatic recording is not started • No electrode detachment is detected for two seconds or more • Five or more QRS waves are detected • Artifact and high frequency noise are not detected • The lead group is periodically switched

5

You can manually extend a lead group recording by pressing the AUTO/ MANUAL key. This is not available for the review recording. During extended recording, the AUTO/MANUAL lamp blinks. To change to the next lead group, press the AUTO/MANUAL key again. After the lead group which includes lead V6 is recorded, the electrocardiograph automatically stops recording and the ECG analysis result is printed (unless “Report print out” is set to Off on the System Setting screen).

To manually stop recording, press the START/STOP key.

When recording the ECG waveforms of another patient without changing the ID, the same ID confirmation message appears.

To record the waveforms with the same ID, press the Start function key. To change the ID, press the Edit ID function key. To cancel recording, press the Cancel function key.


5.13

5. RECORDING RESTING ECG WAVEFORMS Extended Recording The electrocardiograph automatically extends the recording when “Extended recording” on the Auto Recording of the Main Setup screen is set to “On: sequence (full page)” or “On: rhythm (full page)” in automatic recording. Extended rhythm recording: When an arrhythmia is detected, it starts rhythm recording following the format set on the Rhythm Recording of the Recording Settings in the Main Setup screen after automatic recording ends. While acquiring the rhythm lead, the START/ STOP lamp lights. To stop recording, press the START/STOP key once. This stops acquiring waveforms. To stop printing, press the START/STOP key again. Extended sequence recording: Extends the lead group recording when fluctuation of 20% of R-R interval is detected. The extended recording timing is set on the “Time” setting on the Recording Settings of the Auto Recording in the Main Setup screen. Saving the ECG Data File The 12 lead ECG waveforms (including extended sequence recording and extended rhythm recording), analysis result and patient information are automatically saved as an ECG data file in a media when the “After analysis result recording” on File Processing of the Main Setup screen is set to “Save”. When “After analysis result recording” on the File Processing of the Main Setup screen is set to “Off”, “File” is displayed in the message and key function display area. Press the File function key to select the file operation.

To save the ECG data file, press the Save function key. To cancel saving, press the Cancel function key.

5.14



5

When the selected media (internal memory or SD memory card) becomes full during saving, the “Media is full” message appears. Select another media and save the files again. When the “File auto delete” is set to “On” on the Main Setup screen, the oldest files are automatically deleted and the new files are saved.

Printing Another Copy of the Recording Results After automatic and rhythm recording, the COPY/CAL key lamp lights. You can make one or more copies of the recording results by pressing the COPY/CAL key. The automatic and rhythm recording result can be printed. The word “COPY” is also printed at the top of the recording paper to distinguish it from automatic and rhythm recording results. If the FILTER key setting is changed, the changed setting applies to the printing. When the FILTER lamp lights, EMG filter is applied. When it is off, the high cut filter is applied. When “Auto gain output” is set to “Auto gain + setting gain” in the Auto Recording, the auto gain is applied. When it is set to “Setting gain + auto gain”, the setting gain is applied to the printing.


5.15


Manual Recording General You can manually record the ECG waveforms. During recording you can annotate the ECG waveforms when there is a change in patient condition such as chest pain or artifact. In manual recording mode, the baseline is automatically adjusted every time recording is started and the lead group or sensitivity can be changed. ECG analysis is not available in manual recording mode.

Preparation for Manual Recording Change the following settings, if necessary. Refer to Section 3 “Changing Settings Before Measurement”. The factory default settings are underlined. To print the current settings, refer to “Printing the List of System Setup and Main Setup Settings” in Section 3. System Setup Wave Settings Baseline drift suppression (Strong, Weak, Off) Baseline drift suppression prevents the baseline from drifting by locking it into one position at the start of recording.

CAUTION When baseline drift suppression is set to “Strong”, distortion may occur in the ST segment with a decrease of heart rate when heart rate is less than 50. For bradycardia, set this item to “Weak”. The “Weak” setting has characteristics conforming to the AHA recommendations.

Main Setup Wave Settings • High cut filter (75 Hz, 100 Hz, 150 Hz) This is active only when the EMG filter is turned off. • EMG suppression frequency (25 Hz, 35 Hz) EMG filter frequency.

CAUTION Take care when judging the ECG recording because the EMG filter may cause distortion of P-waves and QRS-waves depending on the waveform shape.

5.16


5. RECORDING RESTING ECG WAVEFORMS Recording Settings Manual Recording • 12 lead recording channels (3 ch, 1 ch, 1 ch + rhythm) The number of recording channels for the manual recording.

Manual Recording Procedure 1. Check the following before starting recording. • The patient is relaxed. • The electrodes (especially chest electrodes) are not in electrical contact with each other, they are properly attached and there is no artifact. 2. Press the AUTO/MANUAL key to select the manual recording mode. The AUTO/MANUAL lamp is lit when auto recording mode is selected. 3. Select the first lead group. Press the function key.

or,

Enter the number “4 (<)” or “5 (>)” with the keyboard on the operation panel.

12 lead/Cabrera lead 1ch, 1ch + rhythm

aVF I II III aVR aVL *(aVL I -aVR II aVF III)

V1

V2

V3

V4

V5

V6

12 lead/Cabrera lead 3 ch

I, II, III

aVR, aVL, aVF

V1, V2, V3

*(aVL, I, –aVR) (II, aVF, III)

V4, V5, V6

* Parentheses indicate Cabrera lead. • To change the sensitivity Press the 10 mm/mV function key. or, Press the F1 key. 10 mm/mV

5 mm/mV

20 mm/mV

• To change the paper speed Press the 25 mm/s function key. or, Operator’s Manual ECG-1150

5.17

5

5. RECORDING RESTING ECG WAVEFORMS Press the “25 mm/s” or “50 mm/s” function key with the keyboard on the operation panel to change the paper speed. 25 mm/s

50 mm/s

• To turn on the EMG filter Press the FILTER key. • To annotate the ECG waveform with a dotted line Press the FEED/MARK key. A dotted line is continuously printed while this key is pressed. 4. Press the START/STOP key to start recording. 5. Select the next lead group. Press the function key.

When the lead group is changed, the calibration waveform is automatically recorded.

6. Repeat step 5 to record all lead groups. 7. When all lead groups are recorded, press the START/STOP key to stop recording.

5.18



Rhythm Recording General Before or after automatic or manual ECG recording, you can perform rhythm recording. The settings are set on the Rhythm Recording of the Recording Settings in the Main Setup screen.

Rhythm Recording Procedure Press the RHYTHM key. The electrocardiograph starts to acquire the ECG waveforms and the elapsed time from the start of ECG waveform acquisition is displayed at the bottom right of the screen. When one minute of ECG waveforms are acquired, recording starts. or

To stop ECG waveform acquisition, press the RHYTHM key or START/STOP key. After recording, you can make one or more copies of the recording results by pressing the COPY/CAL key. NOTE To stop rhythm recording, press the Cancel function key.


5.19

5


Recording Examples Auto Recording Examples Standard 12 Lead ECG Baseline drift suppression indications D - Strong d - Weak None - Off AC filter indications H50: 50 Hz AC filter H60: 60 Hz AC filter None: Off

High cut filter and EMG filter indications 150 Hz: 150 Hz High cut filter 35 Hz: 35 Hz EMG filter 100 Hz: 100 Hz High cut filter 25 Hz: 25 Hz EMG filter 75 Hz: 75 Hz High cut filter

Patient information

Analysis result

Measurement value

Cabrera Lead ECG

5.20



Manual Recording Examples Standard 12 Lead ECG

5

Cabrera Lead ECG

Rhythm Recording Examples 1 ch, 1 min


5.21

Section 6 Periodic ECG Recording General................................................................................................................................................................. 6.2 Preparation for Periodic ECG Recording.............................................................................................................. 6.3 Starting Periodic Recording.................................................................................................................................. 6.4 Recording Examples............................................................................................................................................ 6.5


6.1

6

6. PERIODIC ECG RECORDING

General The electrocardiograph can automatically perform automatic recording at periodic intervals. For automatic recording, refer to Section 5 “Recording Resting ECG Waveforms”. You can also perform automatic and manual recording during periodic ECG recording.

6.2



Preparation for Periodic ECG Recording Change the following settings, if necessary. Refer to Section 3 “Changing Settings Before Measurement”. The factory default settings are underlined. To print the current settings, refer to “Printing the List of System Setup and Main Setup Settings” in Section 3.

6

System Setup Periodic Recording Settings • Starting leads (Limb, Chest) Select the starting lead group. • Periodic recording type (Fixed time, Interval, Off) Select the ECG waveform acquisition interval. • Fixed recording time (30 s, 1 to 15 min) Select “On” to acquire the ECG waveform after the specified time when “Periodic recording type” is set to “Fixed time”. • Interval (m) (1 to 60 (3)) Select the interval when “Periodic recording type” is set to “Interval”. Change function key increments the value by 1 step. FILTER key increments the value by 10 steps. • Interval recording repetitions (1 to 999 (10)) Select the number of times to acquire ECG waveform. Change function key increments the value by 1 step. FILTER key increments the value by 10 steps. • Auto gain output (On, Off) Select “On” to automatically change the waveform amplitude and position during periodic recording. • Additional slow speed recording (On, Off) Select “On” to slow paper speed until the next periodic recording starts. Main Setup Recording Settings Manual Recording 12 lead recording channels (3 ch, 1 ch, 1 ch + rhythm) 3 ch: II, aVF, V5 1 ch: II


6.3


Starting Periodic Recording 1. Press the MODE key. The Main Menu screen is displayed.

2. Press “2” to select “Periodic Recording”. The Periodic ECG recording screen appears.

3. Press the Start function key.

Periodic recording starts with the preset settings.

To perform automatic or manual recording during periodic recording i) Press the START/STOP key. ii) Select automatic or manual recording with the AUTO/MANUAL key. iii) Press the START/STOP key again to start recording. After recording, the periodic recording automatically resumes.

4. To turn off periodic recording, press the MODE key to display the Main Menu screen.

6.4



Recording Examples

6


6.5

Section 7 Data Management General................................................................................................................................................................. 7.2 Displaying the Data Management Screen............................................................................................................ 7.3 Printing ECG Waveforms in a Media.................................................................................................................... 7.4 Editing ID.............................................................................................................................................................. 7.6 Deleting ECG Data Files...................................................................................................................................... 7.9 Displaying the Delete Screen..................................................................................................................... 7.9 Deleting All ECG Data Files....................................................................................................................... 7.9 Deleting ECG Data Files of the Selected ID............................................................................................. 7.11 Deleting ECG Data Files of the Selected Date......................................................................................... 7.13 Formatting the Media.......................................................................................................................................... 7.16 Printing File List.................................................................................................................................................. 7.18 Copying Files in the Internal Memory to an SD Card......................................................................................... 7.20


7.1

7

7. DATA MANAGEMENT

General In automatic recording mode, the ECG waveforms, analysis result and patient information can be saved as an ECG data file in a media. On the Data Management screen, you can do any of the following operations. • Print the ECG waveforms in a media • Change the ID of the selected file • Delete ECG data files in a media • Format media • Print the ECG data file list of the selected date in a media • Copy the ECG data files in the internal memory to the SD memory card To process an ECG data file, select “Media” in “File Processing” in the Main Setup screen. The selected media is displayed in the header of the screen. There are two types of data save format, type 1 (normal) and type 2 (compressed). The type can be set in “Data compression type” in “File Processing” in the User Setup screen. • When the internal memory is selected, up to 40 ECG data files can be saved regardless of the data compression type. • When the SD memory card is selected, up to 780 (type 1) or 3000 (type 2) files can be saved.

CAUTION • Format the SD memory card before the first use. • Format the SD memory card only in an ECG-1150 electrocardiograph. SD memory cards formatted in other ECG models cannot be used in this electrocardiograph.

7.2


7. DATA MANAGEMENT

Displaying the Data Management Screen 1. Press the MODE key. The Main Menu screen appears.

7

2. Press “7” to select “Data Management”. The Data Management screen appears.

The number of ECG data files which are saved in the media is displayed at the upper right of the screen. The remaining free space in the media is displayed at the lower right of the screen. The number of ECG data files in the media

Media

Free space in the media


To select the desired item, press the number of the item with the keyboard on the operation panel. The screen of the selected item is displayed.

To close the Data Management screen, press the MODE key. The Main Menu screen appears. 7.3

7. DATA MANAGEMENT

Printing ECG Waveforms in a Media You can print the ECG waveforms of the selected ID in a media. 1. Select SD card or Internal memory in “Media” of the Main Settings. Refer to Section 3 “Changing Settings Before Measurement”. 2. Display the Data Management screen. Refer to the “Displaying the Data Management Screen”on the previous page. 3. Press “1” to select “Print”. The “Press Enter to enter ID. Press Search to search files for ID” message appears.

4. Press the Enter function key. The “Enter the ID” message appears.

7.4


7. DATA MANAGEMENT 5. Enter the ID with the following keys and press the START/STOP (enter) key. The ID is set and the “Press Enter to enter ID. Press Search to search files for ID.” message appears. Numeric

Key

Numeric

Key

0

COPY/CAL key

6

AGE key

1

F1 function key

7

GENDER key

2

F2 function key

8

FEED/MARK key

3

F3 function key

9

FILTER key

4

MODE key

—

F4 function key

5

RHYTHM key

Clear

AUTO/ MANUAL key

Enter

7

START/STOP key

6. Press the Search function key. The file list of the entered ID appears.

7. Select the file and press the Print function key. The ECG data of the selected file is printed.


7.5

7. DATA MANAGEMENT

Editing ID You can edit the ID after recording ECG waveforms. 1. Display the Data Management screen. Refer to “Displaying the Data Management Screen” in this section. 2. Press “2” to select “Edit ID”. The “Press Enter to enter ID. Press Search to search files for ID” message appears.

3. Press the Enter function key. The “Enter the ID” message appears.

7.6


7. DATA MANAGEMENT 4. Enter the ID with the following keys and press the START/STOP (enter) key. The ID is set and the “Press Enter to enter ID. Press Search to search files for ID.” message appears. Numeric

Key

Numeric

Key

0

COPY/CAL key

6

AGE key

1

F1 function key

7

GENDER key

2

F2 function key

8

FEED/MARK key

3

F3 function key

9

FILTER key

4

MODE key

—

F4 function key

5

RHYTHM key

Clear

AUTO/ MANUAL key

Enter

7

START/STOP key

5. Press the Search function key. The file list of the entered ID appears.

6. Select the file and press the Edit function key. The “Change the ID” message appears.


7.7

7. DATA MANAGEMENT 7. Press the Enter function key. The “Enter the ID” message appears.

8. Enter the new ID with the keys on the operation panel and press the START/ STOP (enter) key. The new ID is set and the “Edit complete” message appears.

9. Press the OK function key The previous file list without the changed ID data appears.

7.8


7. DATA MANAGEMENT

Deleting ECG Data Files NOTE Back up the ECG data files before deleting the ECG data files. You can delete all ECG data files, ECG data files of the selected date or ECG data files of the selected ID in the media.

Displaying the Delete Screen 7

1. Display the Data Management screen. Refer to “Displaying the Data Management Screen” in this section. 2. Press “3” to select “Delete”. The Data Management - Delete screen appears.

To return to the Data Management screen, press the Back function key.

Deleting All ECG Data Files You can delete all ECG data files from the media. 1. Display the Data Management - Delete screen. Refer to the above “Displaying the Delete Screen” section.


7.9

7. DATA MANAGEMENT 2. Press “1” to select “All files”. The “Delete all files?” message appears.

3. Press the OK function key. The “Deleting ECG file. Do not turn the power off” message appears.

7.10

To cancel deleting, while deleting the ECG data files, press the Cancel function key. After the current ECG data file is deleted, the deleting of the remaining files is canceled. The “Canceled” message and the number of deleted files appears. Press the OK function key. The Data Management screen appears.


7. DATA MANAGEMENT 4. When all files are deleted, the “All files deleted” message appears. Press the OK function key. The Data Management screen appears.

7

Deleting ECG Data Files of the Selected ID You can delete ECG data files of the selected ID from the media. 1. Display the Data Management - Delete screen. Refer to “Displaying the Delete Screen” in this section.

2. Press “2” to select “Selected ID”. The “Press Enter to enter ID. Press Search to search files for ID” message appears.


7.11

7. DATA MANAGEMENT 3. Press Enter function key. The “Enter the ID” message appears.

4. Enter the ID with the following keys and press the START/STOP (enter) key. The ID is set and the “Press Enter to enter ID. Press Search to search files for ID.” message appears again. Numeric

Key

Numeric

Key

0

COPY/CAL key

6

AGE key

1

F1 function key

7

GENDER key

2

F2 function key

8

FEED/MARK key

3

F3 function key

9

FILTER key

4

MODE key

—

F4 function key

5

RHYTHM key

Clear

AUTO/ MANUAL key

Enter

START/STOP key

5. Press Search function key. The file list of the selected ID is displayed.

7.12


7. DATA MANAGEMENT 6. Select the file and press the Delete function key. The “Delete the selected data?” message appears.

7

7. Press the OK function key to delete the data. 8. When the selected files are deleted, the “Files delete” message appears. Press the OK function key. The Data management screen appears.

Deleting ECG Data Files of the Selected Date You can delete ECG data files of the selected date from the media. 1. Display the Data Management - Delete screen. Refer to “Displaying the Delete Screen” in this section.


7.13

7. DATA MANAGEMENT 2. Press “3” to select “Selected date”. The “Press Enter to enter Date. Press Delete to delete files” message appears.

3. Press the Enter function key. The “Enter the date. Files will be deleted” message appears.

4. Enter the ID with the following keys and press the OK function key. The files of the selected date are deleted. Numeric

7.14

Key

Numeric

Key

0

COPY/CAL key

6

AGE key

1

F1 function key

7

GENDER key

2

F2 function key

8

FEED/MARK key

3

F3 function key

9

FILTER key

4

MODE key

—

F4 function key

5

RHYTHM key

Clear

AUTO/ MANUAL key

Enter

START/STOP key


7. DATA MANAGEMENT 5. When the selected files are deleted, the “Files deleted” message appears. Press the OK function key. The Data management screen appears.

7


7.15

7. DATA MANAGEMENT

Formatting the Media You can format a media in the electrocardiograph.

CAUTION

CAUTION

Only use a Nihon Kohden specified SD memory card. Otherwise, the card might not operate.

• Format the SD memory card before the first use. • Format the SD memory card only in an ECG1150 electrocardiograph. SD memory cards formatted in other ECG models cannot be used in this electrocardiograph.

NOTE Formatting deletes all data in the media. Back up the necessary data before formatting. 1. Insert the SD memory card into SD card slot on the rear panel of the electrocardiograph.

To format the internal memory skip this step.

2. Display the Data Management screen. Refer to “Displaying the Data Management Screen” in this section. 3. Press “4” to select “Format”. The Data Management - Format screen appears.

7.16

To cancel formatting, press the Cancel function key. The Data Management screen appears.


7. DATA MANAGEMENT 4. Press the OK function key. The “Formatting. Do not turn the power off” message appears.

7

5. When the formatting is complete, the “Formatting complete” message appears. Press the OK function key. The Data Management screen appears. NOTE Do not turn the electrocardiograph power off while displaying the Data Management - Format screen and do not give an impact to the electrocardiograph.


7.17

7. DATA MANAGEMENT

Printing File List You can print a list of the ECG data that are saved in the media. The list includes measurement date, ID, gender, age and measurement mode. 1. Display the Data Management screen. Refer to “Displaying the Data Management Screen” in this section. 2. Press “5” to select “Print file list”. The “Enter the date” message appears.

3. Press the Enter function key. The cursor appears on the date.

7.18


7. DATA MANAGEMENT 4. Enter the date with the following keys and press the OK function key. The date is set. Numeric

Key

Numeric

Key

0

COPY/CAL key

6

AGE key

1

F1 function key

7

GENDER key

2

F2 function key

8

FEED/MARK key

3

F3 function key

9

FILTER key

4

MODE key

—

F4 function key

5

RHYTHM key

Clear

AUTO/ MANUAL key

Enter

7

START/STOP key

5. Press the Print function key. The file list of the selected date is printed.


7.19

7. DATA MANAGEMENT

Copying Files in the Internal Memory to an SD Card You can copy the ECG data files saved in the internal memory to the SD card. 1. Display the Data Management screen. Refer to “Displaying the Data Management Screen” in this section. 2. Press “6” to select “Copy int memory > SD”. The “Copy internal memory files to the SD card?” message appears.

3. Press the OK function key. The “Copying ECG file. Do not turn the power off” message appears.

To cancel while copying files, press the Cancel function key. The “Canceled” message and the number of copied files appears. Press the OK function key. The Data management screen appears.

4. When all files are copied, the “All files copied” message appears. Press the OK function key. The Data Management screen appears.

7.20


Section 8 Troubleshooting and Error Messages Recording Clear ECG Waveforms........................................................................................................................ 8.2 AC Interference.......................................................................................................................................... 8.2 Muscle Tremor Interference (EMG)............................................................................................................ 8.2 Wandering Baseline................................................................................................................................... 8.3 Abnormal Printout...................................................................................................................................... 8.3 Other.......................................................................................................................................................... 8.4 Troubleshooting.................................................................................................................................................... 8.5 Error Messages.................................................................................................................................................... 8.7 Checking the Software Version............................................................................................................................. 8.9


8.1

8

8. TROUBLESHOOTING AND ERROR MESSAGES

Recording Clear ECG Waveforms AC Interference Appears on the ECG as even-peaked, regular voltages superimposed throughout the tracing. It may appear in conjunction with muscle tremor.

Causes: • Dirty or corroded lead wire tips or electrodes • Loose electrode connection • Patient or technician touching an electrode during recording • Patient touching any metal part of a bed or examination table • Broken lead wire, patient cable or power cord • Electrical devices in the immediate area, lighting, concealed wiring in walls or floors • Improperly grounded electrical outlet

Muscle Tremor Interference (EMG) Appears on the ECG as random, irregular voltages superimposed on the tracing. It may resemble or occur in conjunction with AC interference.

Causes: • Patient is uncomfortable, tense, nervous or apprehensive • Patient is cold and shivering • Patient has a neurological or muscular disorder (e.g. Parkinson’s Disease) • Examination table or bed is too narrow or short to support limbs comfortably

8.2



Wandering Baseline Appears on the ECG as a fluctuation of the tracing up and downward on the grid.

Causes: • Dirty or corroded electrodes • Loose electrodes or electrodes positioned on a bony area • Insufficient or dried out cardioCream • Oily skin or body lotions and creams • Rising and falling of chest during normal or apprehensive respiration

8

When wandering baseline occurs: • Clean skin with alcohol or acetone if necessary • Reposition electrodes • Check the electrode connections • Have the patient relax

Abnormal Printout During ECG recording, loose or poor electrode contact causes waveform saturation, excessive AC interference, etc. In this case, the electrocardiograph stops printing to protect the thermal head. Check the electrode attachment.


8.3


Other When an electrosurgical unit (ESU) is used with the electrocardiograph, noise generated by an ESU is superimposed on the ECG waveforms. Equipment in the same room as the electrocardiograph may generate noise on the ECG waveforms. • Noise from an electrosurgical unit • Noise from the AC power line • Spike noise caused by electrostatic energy as shown below. The ECG may interpret the noise spike as a QRS or pacemaker spike.

NOTE The baseline becomes flat for a while after defibrillation to protect the electrocardiograph.

8.4



Troubleshooting When trouble occurs, take quick action referring to the table below. If there is any damage or the electrocardiograph is suspected to be faulty as a result of checking, turn the power off, attach an “Unusable” or “Repair request” label to the electrocardiograph and contact your Nihon Kohden representative. Trouble When the POWER key is pressed, the electrocardiograph does not operate on AC power (the POWER lamp is not lit). When the POWER key is pressed, the electrocardiograph does not operate on battery power (the POWER lamp and battery operation lamp are not lit).

Action Check that the power cord is firmly connected to the electrocardiograph and AC socket.

1. Check that the battery is inserted in the electrocardiograph correctly. 2. Check the battery. If it is almost discharged, operate the electrocardiograph on AC power or recharge the battery. If the remaining battery operation time is less than 15 minutes, replace it with a new one. Nothing can be printed. 1. Check that the recording paper is set correctly. If the “Check paper and recorder” message appears and notification sounds, there is no recording paper. Correctly set the recording paper. 2. Check that the recorder cover is firmly closed. 3. If the START/STOP lamp is not lit, press and hold down the START/STOP key until the lamp is lit. 4. If “Report print out” is set to Off in the system settings, set it to On. Refer to “Recording Settings” in Section 3. During battery operation, the power is 1. Check the battery. If it is almost discharged, operate the turned off during recording. electrocardiograph on AC power or recharge the battery. If the remaining battery operation time is less than 15 minutes, replace it with a new one. 2. Check that the battery is inserted in the electrocardiograph correctly. 3. If the battery has been used more than one year, replace it with a new one. The power is turned off during recording Check the internal memory with “Memory Test” in the System Test. If on either AC or battery operation. the memory is faulty, contact your Nihon Kohden representative. If the memory is not faulty, power loss might be caused by static electricity. Keep the electrocardiograph away from materials which generate electrostatic discharge such as curtains. The screen turns black when operating on When “Backlight auto off” is set to On in the system settings, the LCD AC power. screen automatically turns off to save power. Press any key to turn the screen on again. The power is turned off when operating on The power is automatically turned off when the “Fail” message battery power. (electrode detachment) is displayed on the screen and there is no key operation for approximately three minutes to save the battery power. Press the POWER key to resume operation. Refer to “Automatic power off” in “AC and Battery Operation” of Section 1.


8.5

8

8. TROUBLESHOOTING AND ERROR MESSAGES Trouble No ECG waveform can be recorded even when the electrodes are attached to the patient correctly.

Action 1. Check the continuity of the patient cable with “Electrode Input Test” in the System Test. 2. Check that the electrodes are clean. If an electrode is contaminated with electrolyte cream (cardioCream), the ECG waveform cannot be recorded due to high skin-electrode contact impedance. Wash the electrode to remove dirt or contamination. 3. If a new and old electrode, or a reusable and disposable electrode are used together, the ECG waveform cannot be recorded due to high polarization voltage. Do not use different types or ages of electrodes together. 4. Check if the skin is cleaned and apply electrolyte cream (cardioCream) before attaching the electrodes. 5. If a disposable electrode is used more than once, the ECG waveform cannot be recorded due to polarization voltage. Only use new electrodes. Select the first lead group by pressing the function key. Cannot record all electrodes. Analysis result recording cannot be 1. If the recording time is less than 10 seconds, the electrocardiograph performed. does not analyze the acquired ECG waveform. Record the ECG waveform at least 10 seconds. 2. When the printed heart rate is “***”, the electrocardiograph did not detect the QRS waves because the amplitude of lead II, V1 and V5 are too small. Always check that the heart rate correctly appears on the screen before pressing the START/STOP key. Recording result is partially missing or When the thermal head is touched with a dirty hand, or comes in faint. contact with cardioCream or physiological saline solution, this causes missing dots on the recording or reduces recording intensity. Clean the thermal head with the thermal head cleaner. Take care not to touch the thermal head with a dirty hand when setting the recording paper. The electrocardiograph does not print Excessive noise during printing causes the electrocardiograph does not anything or recording result is faint. print anything or faint printing to protect the thermal head. Check that noise is not superimposed on the waveform on the screen and restart printing. Paper skews as it feeds. 1. Check if the specified recording paper is used. 2. Set the recording paper straight by aligning it with the paper guide. 3. When the thermal head is dirty, the recording paper may skew. Clean the thermal head with the thermal head cleaner. Paper gets jammed in the recorder. Set the recording paper as specified in “Setting the Recording Paper” in Section 2. The screen is not bright and the waveform Adjust the screen brightness. Refer to “Adjusting the Screen cannot be read. Brightness” in Section 2. The date and time is not correct. 1. Set the correct time in the system settings. Refer to “Changing the Date and Time” in Section 3. 2. Replace the built-in lithium battery. The lifetime of the battery is about 6 years. Keys on the operation panel do not work. 1. Press the POWER key for more than 7 seconds to shut down the electrocardiograph. If the cause of the trouble is freezing of the software by static electricity, the electrocardiograph turns off. 2. Press the POWER key for one second to turn the power on. If error information prints out, contact your Nihon Kohden representative. The power is not turned off by pressing the Press the POWER key for more than 7 seconds to shut down the POWER key. electrocardiograph. If the cause of the trouble is freezing of the software by static electricity, the electrocardiograph turns off. If you cannot restart the electrocardiograph, attach an “Unusable” or “Repair request” label to the electrocardiograph and contact your Nihon Kohden representative. Press the POWER key for one second to turn the power off. If the electrocardiograph is not turned off, there is a failure in the electrocardiograph. Attach an “Unusable” or “Repair request” label to the electrocardiograph and contact your Nihon Kohden representative. 8.6



Error Messages When an error message is displayed on the screen, take quick action referring to the table below. Error Message Battery trouble

Cause The battery contact voltage is high.

Cannot make file list/ Cannot print file list

There are no ECG data files.

Charge battery Check paper and recorder

Could not save ECG file Delete error Edit error Fail

Format error Insert SD card Invalid ECG data files


The ECG data file was saved by another electrocardiograph. No recording paper. Battery is low. No recording paper. The recorder cover is not closed firmly. The electrocardiograph received ECG data files from a different model but could not save the files. ––

Action Stop using the electrocardiograph and remove the battery pack. Contact your Nihon Kohden representative. Check that there are ECG data files in the internal memory or SD memory card. The electrocardiograph cannot manage data that is saved by another electrocardiograph. Set the recording paper. Operate the electrocardiograph on AC power or charge the battery pack. Set the recording paper. Push the recorder cover in until it is closed firmly. Retry saving the ECG data files or check the media. Retry deleting the ECG data files or check the media. Contact your Nihon Kohden representative.

The electrocardiograph cannot edit ECG data files. • The indicated electrode is detached Check the electrode attachment of the or a large polarization voltage is indicated position. detected. • If two or more limb electrodes are disconnected or the RF electrode is disconnected, no electrode is indicated in the error message area. Retry formatting the media or check the –– media. The SD memory card is not inserted Retry the operation after inserting the SD in the SD card slot. card in the slot. The electrocardiograph could not Contact your Nihon Kohden representative. load the ECG data files. The file may be damaged.

8.7

8

8. TROUBLESHOOTING AND ERROR MESSAGES Error Message Invalid entry Invalid SD card

Cause The entered data is out of range. The SD memory card is invalid.

Invalid setting file

The setting file could not load correctly. The setting file may be damaged. • Noise superimposed on the indicated electrode waveform. • If noise overlaps on two or more limb electrodes or on the RF electrode, no electrode is indicated in the error message area. There is not enough space to save new ECG data file in the memory. Electrocardiograph overheated because it continuously recorded AC interference superimposed on the waveform. The SD memory card is writeprotected. There is no corresponding patient information data in the selected media. There is no setting file.

Noise

Not enough free memory Overheating. Wait 5 minutes.

SD card write-protected Search error Setting file not found Unsupported file type

8.8

This ECG data file type is not supported.

Action Enter correct values. Replace the SD card with a new one and retry the operation. Contact your Nihon Kohden representative. Check the electrode attachment of the indicated position.

Save the ECG data file in another media or delete unnecessary ECG data files. Remove the cause and wait until this message disappears. Unprotect the SD card and retry the operation. Press the OK function key to close the message window. Change the search condition and search again. Retry the file operation or check the media to load the ECG data file. ––



Checking the Software Version The software version is printed at the bottom of the paper in automatic or manual ECG recording.

8 Model System software

ECG analysis


8.9

Section 9 Maintenance and System Test Check Items After Turning the Power Off.............................................................................................................. 9.2 Cleaning and Disinfecting the Electrocardiograph................................................................................................ 9.3 Cleaning the Surface of the Electrocardiograph......................................................................................... 9.3 Cleaning the Display of the Electrocardiograph......................................................................................... 9.3 Disinfecting the Surface of the Electrocardiograph.................................................................................... 9.4 Cleaning the Thermal Head....................................................................................................................... 9.4 Cleaning the Paper Roller.......................................................................................................................... 9.5 Cleaning the Sensor................................................................................................................................... 9.5 Cleaning the Wheel Gear........................................................................................................................... 9.5 Cleaning and Disinfecting the Patient Cable........................................................................................................ 9.6 Cleaning..................................................................................................................................................... 9.6 Disinfecting................................................................................................................................................. 9.6 Cleaning and Disinfecting Electrodes................................................................................................................... 9.7 Cleaning..................................................................................................................................................... 9.7 Disinfecting................................................................................................................................................. 9.7 Cleaning and Disinfecting Other Options............................................................................................................. 9.7 Regular Check...................................................................................................................................................... 9.8 Clock Accuracy..................................................................................................................................................... 9.9 Periodic Replacement........................................................................................................................................ 9.10 Repair Parts Availability Policy........................................................................................................................... 9.11 System Test Screen............................................................................................................................................ 9.12 System Test Items.................................................................................................................................... 9.12 Displaying the System Test Screen.......................................................................................................... 9.13


9.1

9

9. MAINTENANCE AND SYSTEM TEST

Check Items After Turning the Power Off After use, check the following items for the next use. Overview: • Electrocardiograph is not dirty, damaged or in contact with liquid • No peeling or tear in the operation panel • No key or button is broken • Electrodes are clean and not damaged • Power cord is not damaged • Cable hanger is not damaged • Recorder is not damaged Accessories: • Enough electrolyte cream • Enough recording paper • Enough disinfected or sterilized dry electrodes • Patient cable is not frayed or damaged • Electrode lead is not damaged • No crack in the rubber of suction electrodes Storage: • Electrodes are washed • The battery is fully recharged • The thermal head is clean • The sensor is clean • The power is turned off • No chemicals or water are near the electrocardiograph • Acceptable storage temperature and humidity

9.2



Cleaning and Disinfecting the Electrocardiograph

CAUTION Do not use volatile liquids such as thinner or benzine, because these will cause the materials to melt or crack.

CAUTION Before maintenance, cleaning or disinfection, turn the electrocardiograph power off and disconnect the power cord from the AC socket. Failure to follow this instruction may result in electrical shock and electrocardiograph malfunction.

9 CAUTION • After cleaning, make sure that the electrocardiograph is completely dried. • Never sterilize the electrocardiograph because the materials may deform, crack or discolor. • The “CAUTION LABEL” contains important information for operating the electrocardiograph. Clean the label if it is dirty. If the label is damaged or difficult to read, contact your Nihon Kohden representative to replace it with a new one.

Cleaning the Surface of the Electrocardiograph Clean the outside surface of the electrocardiograph with a soft cloth moistened with water, neutral soap or alcohol (76.9 to 81.4 vol%) and wrung out. Use a dry cloth when you wipe the connector of the electrocardiograph, input box or operation panel. Otherwise, water gets inside the electrocardiograph and causes malfunction.

Cleaning the Display of the Electrocardiograph CAUTION • Do not use a rough cloth. • Do not use acidic, alkaline detergents or alcohol other than ethanol or isopropyl.

Clean the display using a dry soft cloth or a cloth which is moistened with neutral soap and wrung out.


9.3


Disinfecting the Surface of the Electrocardiograph CAUTION • Wipe the electrocardiograph thoroughly after disinfecting it with spray. • Do not sterilize or disinfect the electrocardiograph with ultraviolet light or ozone. • Do not use hypochlorous acid for disinfecting.

To disinfect the outside surface of the electrocardiograph, wipe it with a soft cloth moistened with any of the disinfectants listed below. Use the recommended concentration. Disinfectant Chlorhexidine gluconate solution Benzethonium chloride solution Glutaraldehyde solution

Concentration (%) 0.5 0.2 2.0

Benzalkonium chloride Alkyldiaminoethylglycine hydrochloride

0.2 0.5

Cleaning the Thermal Head CAUTION • Do not clean the thermal head right after recording because the head is still hot. • Only clean the head with the provided thermal head cleaner pen. Otherwise the thermal head may be damaged.

To protect the thermal head from abrasion or damage and assure optimum performance and long service life, clean the surface of the head with the provided thermal head cleaning pen after every 10 sets of recording paper. 1. Turn off the electrocardiograph before cleaning the thermal head. 2. Push the paper magazine release button and open the paper magazine. 3. Clean the gray colored part of the thermal head with the thermal head cleaner pen.

9.4



Cleaning the Paper Roller Paper roller

If the paper roller is dirty, clean the paper roller surface with gauze moistened with alcohol.

Cleaning the Sensor The paper empty sensor is located as shown left. Clean the sensor surfaces with a cotton swab moistened with alcohol.

9

Paper empty sensor

Cleaning the Wheel Gear Wheel gear


If the wheel gear is dirty, clean the wheel gear surface with a cotton swab moistened with alcohol.

9.5


Cleaning and Disinfecting the Patient Cable Cleaning CAUTION Do not immerse the connector in liquid.

CAUTION Do not use volatile liquids such as thinner or benzine, because these will cause the materials to melt or crack.

Clean the patient cable using a soft cloth or a cloth moistened with neutral soap or water and wipe with a dry cloth. Make sure that the patient cable is completely dried after cleaning. If you leave electrolyte cream (cardioCream) on the patient cable surface and leave the tip wet, it may cause inaccurate ECG recording due to high skin electrode contact impedance.

Disinfecting CAUTION • Do not use hypochlorous acid for disinfecting. • Wipe the patient cable thoroughly after disinfecting it with spray.

To disinfect the electrode, wipe it with a soft cloth moistened with any of the disinfectants listed below. Use the recommended concentration. Disinfectant Chlorhexidine gluconate solution Benzethonium chloride solution Glutaraldehyde solution Benzalkonium chloride Alkyldiaminoethylglycine hydrochloride

9.6

Concentration (%) 0.5 0.2 2.0 0.2 0.5



Cleaning and Disinfecting Electrodes Cleaning CAUTION Do not use volatile liquids such as thinner or benzine, because these will cause the materials to melt or crack.

Wipe the electrode using a gauze moistened with below 35°C (95°F) warm water and neutral soap or invert soap or, cotton moistened with alcohol. Make sure that the electrode is completely dried after cleaning. If you leave electrolyte cream (cardioCream) on the electrode surface or leave the metal part wet, it may cause inaccurate ECG recording due to high skin electrode contact impedance.

Disinfecting CAUTION Do not sterilize electrodes by boiling. It may damage the electrode.

To disinfect the electrode, wipe it with a soft cloth moistened with any of the disinfectants listed below. Use the recommended concentration. Disinfectant Ethanol Benzalkonium chloride Benzethonium chloride solution

Concentration (%) 76.9 to 81.4 vol% 0.2 0.2

Cleaning and Disinfecting Other Options Refer to the operator’s manual of each option.


9.7

9


Regular Check Check the following items regularly to keep your instrument in optimal condition. Overview: • Electrocardiograph is not dirty, damaged or rusty • Electrocardiograph and cart are not broken or rattling • Recorder cover release button is not broken Input circuit: • Electrode lead is not cut or broken • Sensitivity and time constant are correct • AC filter and high-cut filter operate correctly • Patient cable is not dirty or damaged • Patient cable is not broken Screen: • Contrast and backlight brightness are correct • Battery charge lamp operates correctly • Waveform display and other screen display are correct Recorder: • Specified recording paper is used • Paper feed properly • No missing dots on printing • Paper empty sensor operates correctly Power: • Power cord is not broken • Supplied voltage is correct Operation: • Electrocardiograph passes all check items in the System Test screen • QRS synchronization sound and notification sound are correct • System settings are correct and are saved correctly • Date and time are correct Safety: • No current leakage PC card and accessories: • SD memory card operates correctly • Enough accessories

9.8



Clock Accuracy At an operating temperature of 5 to 40°C, the accuracy of the clock IC of this instrument is about –1 min 13 s to +1 min 15 s per month. At storage temperatures of –20 to +65°C, the accuracy of the clock IC of this instrument is about –12.6 s to –3 min 49 s per month. Periodically check that the date and time on the printing result is correct. To change the time setting, refer to “Changing the Date and Time” in Section 3.

9


9.9


Periodic Replacement To maintain the performance of the electrocardiograph, the following parts must be periodically replaced by qualified service personnel. Built-in battery One year When the battery deteriorates, the battery operation time is less than 30 minutes after 10 hours charging. Replace the battery with a new one if operation time is less than 30 minutes after charging. LCD 75,000 hours When the LCD deteriorates, the screen display becomes darker. The initial screen brightness is reduced to half after 75,000 hours. Built-in lithium battery 6 years This battery backs up system settings and system clock. When the battery power is low, the time is not accurately recorded and the system settings returns to the factory default settings. Thermal head 30 km continuous recording When the thermal head wears out, the recording density gets weaker due to missing dots. Feeder motor 3,000 hours continuous operation When the motor wears out, the recording paper may feed unevenly or at unstable speed. For inspection and replacement of the above parts, consult your Nihon Kohden representative.

9.10



Repair Parts Availability Policy Nihon Kohden Corporation (NKC) shall stock repair parts (parts necessary to maintain the performance of the instrument) for a period of 8 years from the date of delivery. In that period NKC or its authorized agents will repair the instrument. This period may be shorter than 8 years if the board or part necessary for the faulty section is not available.

9


9.11


System Test Screen This section provides brief explanations of each test or function and explains how to display the System Test screen. For details, refer to the Service Manual. There are 10 items in the System Test screen.

System Test Items • Demonstration Waveform:

This is used to demonstrate the electrocardiograph. Dummy 12 lead ECG waveforms are displayed.

• Recorder Test:

This is used to check the recorder by printing a test pattern. Adjust the recorder based on the printout.

• Key Test:

This is used to check the keys on the operation panel. The name of the pressed key is displayed on the screen.

• Memory Test:

This is used to check the memory by comparing the data of the test patterns written to and read from each memory area.

• LCD/LED Test:

The LEDs on the operation panel light up one by one. Then the LCD displays four test patterns.

• Electrode Input Test:

This is used to check if the input analog signal processing circuit detects the lead off condition correctly using the input check jig. If a lead is not connected, the “Error” message is displayed on the screen.

• ECG Input Circuit Test:

In this test, the input analog signal processing circuit generates 1 mV rectangular waveforms that are printed.

• Initialize System Settings:

This resets all system settings to the factory default settings.

• Display Internal Information: This displays the internal temperature and power voltage of the electrocardiograph. • Display Model Information: This displays the model name, software version and analysis version of the electrocardiograph.

9.12



Displaying the System Test Screen 1. Turn the power off.

2. Press the POWER key while pressing the FEED/MARK key. The System Test screen is displayed. 3. Select the desired item with the

or

function key.

4. Press the Test function key or START/STOP key to execute the item. 5. Press the Cancel function key or START/STOP key to finish the item.

9


9.13

Section 10 Reference Specifications..................................................................................................................................................... 10.2 ECG Input...................................................................................................................................... 10.2 Waveform Data Processor............................................................................................................. 10.2 Recorder........................................................................................................................................ 10.2 Power Requirement........................................................................................................................ 10.2 Color LCD (with backlight)............................................................................................................. 10.3 Environment................................................................................................................................... 10.3 Performance................................................................................................................................... 10.3 Dimensions and Weight................................................................................................................. 10.3 Safety Standard............................................................................................................................. 10.3 Electromagnetic Compatibility........................................................................................................ 10.4 Electromagnetic Emissions............................................................................................................ 10.4 Electromagnetic Immunity.............................................................................................................. 10.5 Recommended Separation Distances between Portable and Mobile RF Communications Equipment...................................................................................................................................... 10.7 System Composition for EMC Test................................................................................................. 10.7 General Requirements for Connecting Medical Electrical Systems................................................................... 10.8 Standard Accessories...................................................................................................................................... 10.10 Options and Consumables............................................................................................................................... 10.11 Optional Accessory Kit........................................................................................................................... 10.11 Options for the Electrocardiograph......................................................................................................... 10.12 Character Code List.......................................................................................................................................... 10.13 How to Read the Character Code List.................................................................................................... 10.13


10.1

10

10. REFERENCE

Specifications ECG Input Input impedance: Electrode offset tolerance: Defibrillation-proof: Common mode rejection ratio: Patient leakage current: Standard sensitivity: Internal noise: Interference between channels: Frequency response: Sample rate:

≥ 50 MΩ ≥ ±550 mV Isolated and defibrillator protected only when the following specified patient cable is connected Patient cable: BJ-901D, BJ-902D, BJ-903D, BA-901D, BA-903D, BJ-961D Recovery time: ≤ 10 s (IEC 60601-2-25: 1993 51.102 compatible) ≤ –110 dB ≤ 5 × 10-8 A 10 mm/mV ±5% ≤ 20 µVp-v ≤ –40 dB 150 Hz (≥ 71%, high-cut filter: 150 Hz) 8000 sample/s

Waveform Data Processor Sample rate: Response to minimum signal: EMG filter: High cut filter: AC line filter: Drift filter: Time constant:

500 samples/s, 1.25 µV/LSB ≤ 20 µVp-v 25, 35 Hz (–3 dB) 75, 100, 150 Hz (–3 dB) 50, 60 Hz Weak: 0.1 Hz (–20 dB), Strong: 0.1 Hz (–34 dB) ≥ 3.2 s

Recorder Recording speed accuracy: Printing density: Scanning line density: Number of recording channels: Paper speed: Recording paper: Mechanical noise: Printed data:

≤ ±5% 200 dpi (8 dots/mm), 320 dots/mm2 (25 mm/s) 1 ms 1, 2, 3 10, 25, 50 mm/s 63 mm width, 30 m roll paper ≤ 48 dB at paper speed 25 mm/s Program type, version, date and time, paper speed, sensitivity, lead name, filter, Patient information (ID number, sex, age), event mark, electrode detachment, noise

Power Requirement Line voltage: Line frequency: Power input:

10.2

100 to 240 V AC ±10% 50, 60 Hz 45 VA


10. PREPARATION Battery operation time:

≥ 90 minutes IEC 60601-2-51: 2003.2 56.7 Under the conditions of operating temperature 25°C, 4 ch recording

Color LCD (with backlight) Display size: Resolution: Displayed data:

4.8 inch 320 × 240 dots Waveform, patient information, recording settings, operation mode, heart rate, QRS sync mark, error message, electrode detachment, noise

Environment Operating environment Temperature: Humidity: Atmospheric pressure: Storage environment Temperature: Humidity: Atmospheric pressure: Other:

5 to 40°C (41 to 104°F) 25 to 95% RH (noncondensing) 25 to 80% RH (recording paper) 700 to 1060 hPa

10

–20 to +65°C (–4 to +149°F) –20 to +50°C (–4 to +122°F) (recording paper) 10 to 95% RH 10 to 90% RH (recording paper) 700 to 1060 hPa Indoor portable

Performance Performance standard:

IEC 60601-2-51: 2003

Dimensions and Weight Dimensions: Weight:

260 W × 50 H × 200 D mm (excluding protrusions) Approx. 1.5 kg (without battery or recording paper)

Safety Standard Safety standard: IEC 60601-1: 1988 IEC 60601-1 Amendment 1: 1991 IEC 60601-1 Amendment 2: 1995 IEC 60601-2-25: 1993 IEC 60601-2-25 Amendment 1: 1999 IEC 60601-1-2: 2001 Type of protection against electrical shock: CLASS I EQUIPMENT (AC Powered) Internally Powered EQUIPMENT (BATTERY Powered) Degree of protection against electrical shock: Defibrillator-proof type CF applied part when patient cable BJ-901D, BJ-902D, BJ-903D, BA-901D, BA-903D or BJ-961D is used Degree of protection against harmful ingress of water: IPX0 (non-protected)


10.3

10. REFERENCE Degree of safety of application in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE: Equipment not suitable for use in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE Mode of operation: CONTINUOUS OPERATION Electromagnetic Compatibility IEC 60601-1-2: 2001 IEC 60601-1-2 Amendment 1: 2004 Electromagnetic Emissions This Model ECG-1150 is intended for use in the electromagnetic environment specified below. The customer or the user of the ECG-1150 should assure that it is used in such an environment. Emissions test RF emissions CISPR 11

Compliance Group 1

RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Class B

10.4

Class A

Electromagnetic environment - guidance The ECG-1150 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The ECG-1150 is suitable for use in all establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Complies


10. PREPARATION Electromagnetic Immunity This Model ECG-1150 is intended for use in the electromagnetic environment specified below. The customer or the user of the ECG-1150 should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge ±6 kV contact (ESD) ±8 kV air IEC 61000-4-2

±6 kV contact ±8 kV air

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines ±1 kV differential mode ±2 kV common mode

Surge IEC 61000-4-5

±2 kV for power supply lines ±1 kV for input/output lines ±1 kV differential mode ±2 kV common mode

Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.* Mains power quality should be that of a typical commercial or hospital environment.*

Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short <5% UT (>95% dip in UT) <5% UT (>95% dip in UT) Mains power quality should be that interruptions and for 0.5 cycle for 0.5 cycle of a typical commercial or hospital voltage variations on environment. power supply input 40% UT (60% dip in UT) 40% UT (60% dip in UT) If the user of the ECG-1150 requires lines for 5 cycles for 5 cycles continued operation during power IEC 61000-4-11 mains interruptions, it is recommended 70% UT (30% dip in UT) 70% UT (30% dip in UT) that the ECG-1150 be powered from for 25 cycles for 25 cycles an uninterruptible power supply or a battery. <5% UT (>95% dip in UT) <5% UT (>95% dip in UT) for 5 s for 5 s Power frequency 3 A/m 3 A/m Power frequency magnetic fields should (50/60 Hz) be at levels characteristic of a typical magnetic field location in a typical commercial or IEC 61000-4-8 hospital environment. NOTE 1: UT is the AC mains voltage prior to application of the test level. NOTE 2: Electrostatic energy may generate spike noise which is superimposed on the ECG waveforms. NOTE 3: Noise from AC power line may generate noise which is superimposed on the ECG waveforms. * This electrocardiograph may show temporary degradation during exposure of ESD, fast transients and bursts. Within 10 s the electrocardiograph shall resume normal operation in the previous operating mode, without loss of any system settings or stored data, and shall continue to perform its intended function as described in this manual.


10.5

10

10. REFERENCE

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the ECG-1150, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF IEC 61000-4-6

3 Vrms

3 Vrms

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

Recommended separation distance _ d = 1.2√P _ d = 1.2√P 80 MHz to 800 MHz _ d = 2.3√P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey*1, should be less than the compliance level in each frequency range*2. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 1 * Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ECG-1150 is used exceeds the applicable RF compliance level above, the ECG-1150 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ECG-1150. *2 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

10.6


10. PREPARATION Recommended Separation Distances between Portable and Mobile RF Communications Equipment The ECG-1150 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ECG-1150 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ECG-1150 as recommended below, according to the maximum output power of the transmitter. Separation distance according to frequency of transmitter (m) 150 kHz to 80_ MHz 80 MHz to 800 800 MHz to 2.5 _ MHz _ GHz d = 1.2√P d = 1.2√P d = 2.3√P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Rated maximum output power of transmitter (W)

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

10

System Composition for EMC Test The ECG-1150 electrocardiograph is tested to comply with IEC 60601-1-2: 2001, Amendment 1: 2004 with the following composition. If any part which is not specified by Nihon Kohden is used, the EMC specifications may not comply. Units ECG-1150 electrocardiograph Battery pack, SB-901D Patient cable, BJ-901D Patient cable, BJ-961D Holter card, QM-064D Ground lead type D


Cable length –– –– 3.4 m 3.4 m –– 5m

10.7

10. REFERENCE

General Requirements for Connecting Medical Electrical Systems When more than one electrical instrument is used, there may be electrical potential difference between the instruments. Potential difference between instruments may cause current to flow to the patient connected to the instruments, resulting in electrical shock (micro shock). Therefore, electrical instruments must be appropriately installed as specified in IEC 60601-1-1: 2000 Second edition. The following is an extract from IEC 60601-1-1 “Medical electrical equipment Part 1-1: General requirements for safety”. For details, refer to IEC 60601-1-1 and consult with a biomedical engineer. Examples of combinations of MEDICAL ELECTRICAL EQUIPMENT and non-medical electrical equipment Medically used room Situation No. 1 1a Items A and B in PATIENT ENVIRONMENT

1b Items A and B in PATIENT ENVIRONMENT

1c Item A powered from specified power supply in item B in PATIENT ENVIRONMENT 2 2a Item A in PATIENT ENVIRONMENT and item B in medically used room 2b Item A in PATIENT ENVIRONMENT and item B in medically used room 3 3a Item A in PATIENT ENVIRONMENT and item B in non-medically used room

Inside the PATIENT ENVIRONMENT A

B

IEC 60601

IEC 60601

A

B

IEC 60601

IEC XXXXX

Outside the PATIENT ENVIRONMENT

Non-medically used room

Feasible solution (See clause 19 in all situations)

For B: Additional protective earth or separating transformer

For B: Additional protective earth or separating transformer

A IEC 60601 B IEC XXXXX A

B

IEC 60601

IEC 60601

A

B

IEC 60601

IEC XXXXX

A

For B: See 19.201 and its rationale

B IEC 60601 or IEC XXXXX

IEC 60601

For B: See 19.201 and its rationale

common protective earth

3b Item A in PATIENT ENVIRONMENT and item B in non-medically used room

A

B IEC 60601 or IEC XXXXX

IEC 60601 protective earth

10.8

For B: Additional protective earth or SEPARATION DEVICE

protective earth with potential difference


10. PREPARATION KEY TO TABLE • Additional protective earth: If necessary, provide additional protective earthing, which is permanently connected (see also 58.201). NOTE: Equipment modification may be required. • Separating transformer: If necessary, limit the ENCLOSURE LEAKAGE CURRENT, by using an additional separating transformer according to annex EEE. NOTE 1: No equipment modification is required. NOTE 2: A separating transformer is a transformer with one or more input winding(s) separated from the output winding(s) by at least basic insulation [IEC 60989]. • SEPARATION DEVICE: If necessary, apply SEPARATION DEVICE. • IEC 60601: MEDICAL ELECTRICAL EQUIPMENT in compliance with IEC 60601. • IEC XXXXX: Non-medical equipment in compliance with relevant IEC safety standards.

10


10.9

10. REFERENCE

Standard Accessories NOTE • Only use Nihon Kohden specified parts and accessories to assure maximum performance from your instrument. • When ordering the following accessories/consumables, specify the supply code. When the supply code is not provided with the accessory, specify the model or code number. 1

2

3

No. 1 2 3

10.10

Description Recording paper, RQS63-3 Thermal head cleaner Input check jig

Q’ty 1 1 1

Code No. — — 6114-092972

Supply Code A129 Y011 —


10. PREPARATION

Options and Consumables Optional Accessory Kit NOTE • Only use Nihon Kohden specified parts and accessories to assure maximum performance from your instrument. • When ordering the following options/consumables, specify the supply code. When the supply code is not provided with the accessory, specify the model or code number. YD-100D: 220 to 240 V, IEC ECG lead (3 mm diameter) YD-101D: 100 to 127 V, IEC ECG lead (3 mm diameter) YD-102D: 100 to 127 V, AHA ECG lead (3 mm diameter) YD-103D: 220 to 240 V, IEC ECG lead (4 mm diameter) Description

Q’ty

Supply Code

BA-901D, AHA 3 mm diameter tip

1

K019

BJ-961D, IEC 3 mm diameter tip, thick cable

1

K111

BJ-902D, IEC/DIN 4 mm diameter tip

1

K081

Type H

1

L935

Type N

1

L936

Chest electrode, 3 mm diameter tip, for adult, 3 pcs/set

2

H041

Chest electrode, 4 mm diameter tip, for adult, 3 pcs/set

2

H043

Clip-on limb electrode, 3 mm diameter tip, 4 pcs/set, Fastclip

1

H068

Clip-on limb electrode, 4 mm diameter tip, 4 pcs/set, Fastclip

1

H068K

YD-100D YD-101D YD-102D YD-103D

Patient cable

Power cord


10.11

10

10. REFERENCE

Options for the Electrocardiograph Description Battery pack cardioCream, 100 g Cart Cart Patient cable hanger Patient cable BA-901D, AHA 3 mm diameter tip BA-903D, AHA clip BJ-901D, IEC 3 mm diameter tip, thin cable BJ-902D, IEC/DIN 4 mm diameter tip BJ-903D, IEC/DIN clip BJ-961D, IEC 3 mm diameter tip, thick cable SD memory card SD memory card Ground lead type D

10.12

Q’ty 1 2 1 1 1

Model/Code No. SB-901D Z-101BC KD-104E KD-105D/105E KH-100D

Supply Code X071 F010 — — —

1 1 1 1 1 1 1 1 1

— — — — — — QM-001D QM-064D/QM-064DE —

K019 K020 K079 K081 K082 K111 Y154D Y154B L912


10. PREPARATION

Character Code List Enter the character code to enter the “Hospital” name on the System Settings of the System Setup.

How to Read the Character Code List The character code is a four digit number for each character. Search for the character in the list on the next two pages. Replace the * in the left side number with the number (0 to 9) at the top of the column. If you enter a character code for a blank area which does not have a character, an unexpected character may be entered.

10


10.13

10. REFERENCE Code 010* 011* 012* 013*

1

014* 015* 016* 017* 018* 019* 020* 021* 022* 023*

2

024* 025* 026* 027*

3

4

5

6

7

8

9

Code 080* 081* 082* 083*

8

034* 035* 036* 037* 038* 039* 040* 041* 042* 043* 044* 045* 046* 047* 048* 049* 050* 051* 052* 053* 054* 055* 056* 057* 058*

086* 087* 088* 089* 090* 091* 092* 093*

9

094* 095* 096* 097*

！＂＃＄％＆＇（）＊＋，－．／ 0 1 2 3 4 5 6 7 8 9 ：；＜＝＞？＠ＡＢＣＤＥＦＧＨＩＪＫＬＭＮＯＰＱＲＳＴＵＶＷＸＹＺ［￦］＾＿｀ａｂｃｄｅｆｇｈｉｊｋｌｍｎｏｐｑｒｓｔｕｖｗｘｙｚ｛｜｝￣ ㄱㄲㄳㄴㄵㄶㄷㄸㄹ ㄺㄻㄼㄽㄾㄿㅀㅁㅂㅃ ㅄㅅㅆㅇㅈㅉㅊㅋㅌㅍ ㅎㅏㅐㅑㅒㅓㅔㅕㅖㅗ ㅘㅙㅚㅛㅜㅝㅞㅟㅠㅡ ㅢㅣㅤㅥㅦㅧㅨㅩㅪㅫ ㅬㅭㅮㅯㅰㅱㅲㅳㅴㅵ ㅶㅷㅸㅹㅺㅻㅼㅽㅾㅿ ㆀㆁㆂㆃㆄㆅㆆㆇㆈㆉ ㆊㆋㆌㆍㆎ ⅰⅱⅲⅳⅴⅵⅶⅷⅸ ⅹ ⅠⅡⅢⅣ ⅤⅥⅦⅧⅨⅩ ΑΒΓΔΕΖΗ ΘΙΚΛΜΝΞΟΠΡ ΣΤΥΦΧΨΩ αβγδε ζηθικλμνξο πρστυφχψω

100* 101* 102* 103*

10

060* 061* 062* 063* 064* 065* 066*

104* 105* 106* 107* 108* 110* 111* 112* 113*

11

114* 115* 116* 117* 118* 120* 121* 122* 123*

12

124* 125* 126* 127* 128*

─│┌┐┘└├┬┤ ┴┼━┃┏┓┛┗┣┳ ┫┻╋┠┯┨┷┿┝┰ ┥┸╂ ┒ ┑ ┚ ┙ ┖ ┕ ┎ ┍ ┞ ┟ ┡ ┢ ┦ ┧ ┩ ┪ ┭ ┮ ┱ ┲ ┵ ┶ ┹ ┺ ┽ ┾ ╀ ╁ ╃ ╄ ╅ ╆ ╇ ╈ ╉ ╊

160* 161* 162* 163*

16

164* 165* 166*

068*

168*

069*

169*

072* 073* 074* 075* 076* 077*

㎕㎖㎗ ℓ ㎘㏄㎣㎤㎥㎦㎙㎚㎛㎜㎝㎞㎟㎠㎡㎢㏊㎍㎎㎏㏏㎈㎉㏈㎧㎨㎰㎱㎲㎳㎴㎵㎶㎷㎸㎹㎀㎁㎂㎃㎄㎺㎻㎼㎽㎾㎿㎐㎑㎒㎓㎔ Ω ㏀㏁㎊㎋㎌㏖㏅㎭㎮㎯㏛㎩㎪㎫㎬㏝㏐㏓㏃㏉㏜㏆

170* 171* 172* 173*

17

174* 175* 176* 177*

78*

178*

79*

179*

10.14

2

3

4

5

6

7

8

9

Code 180* 181* 182* 183*

18

184* 185* 186* 187* 188* 189* 190* 191* 192* 193*

19

194* 195* 196* 197* 198* 199* 200* 201* 202* 203*

20

204* 205* 206* 207* 208* 209*

ァアィイゥウェエォオカガキギクグケゲコゴサザシジスズセゼソゾタダチヂッツヅテデトドナニヌネノハバパヒビピフブプヘベペホボポマミムメモャヤュユョヨラリルレロヮワヰヱヲンヴヵヶ

210* 211* 212* 213*

21

214* 215* 216* 217* 218* 219*

АБВГДЕЁЖЗ ИЙКЛМНОПРС ТУФХЦЧШЩЪЫ ЬЭЮЯ а бвгдеёжзий клмнопрсту фхцчшщъыьэ юя

220* 221* 222* 223*

22

224* 225* 226* 227* 228*

129*

167*

071*

1

Æ Ð ª Ħ Ĳ Ŀ Ł Ø Œ º Þ Ŧ Ŋ ㉠㉡㉢㉣㉤㉥㉦㉧㉨㉩㉪㉫㉬㉭㉮㉯㉰㉱㉲㉳㉴㉵㉶㉷㉸㉹㉺㉻ⓐⓑⓒⓓⓔ ⓕⓖⓗⓘⓙⓚⓛⓜⓝⓞ ⓟⓠⓡⓢⓣⓤⓥⓦⓧⓨ ⓩ①②③④⑤⑥⑦⑧⑨ ⑩⑪⑫⑬⑭⑮ ½ ⅓ ⅔ ¼ ¾ ⅛ ⅜ ⅝ ⅞ æ đ ð ħ ı ĳ ĸ ŀ ł ø œ ß þ ŧ ŋ ŉ ㈀㈁㈂㈃㈄㈅㈆㈇㈈㈉㈊㈋㈌㈍㈎㈏㈐㈑㈒㈓㈔㈕㈖㈗㈘㈙㈚㈛⒜⒝⒞⒟⒠ ⒡⒢⒣⒤⒥⒦⒧⒨⒩⒪ ⒫⒬⒭⒮⒯⒰⒱⒲⒳⒴ ⒵⑴⑵⑶⑷⑸⑹⑺⑻⑼ ⑽⑾⑿⒀⒁⒂ ¹ ² ³ ⁴ ⁿ ₁ ₂ ₃ ₄ ぁあぃいぅうぇえぉおかがきぎくぐけげこごさざしじすずせぜそぞただちぢっつづてでとどなにぬねのはばぱひびぴふぶぷへべぺほぼぽまみむめもゃやゅゆょよらりるれろゎわゐゑをん

119*

067*

070*

0

109*

059*

7

085*

099*

033*

6

084*

029*

032*

5

2

、。 · ‥… ¨ 〃 ―∥＼ ∼ ‘ ’ “ ” 〔〕〈〉《》「」『』【】 ±×÷≠ ≤ ≥ ∞∴°′ ″℃Å￠￡￥♂♀∠⊥ ⌒∂∇≡≒§※☆★○ ●◎◇◆□■△▲▽▼ →←↑↓ ↔ 〓≪≫√∽ ∝∵∫∬∈∋⊆⊇⊂⊃ ∪∩∧∨￢ ⇒⇔∀∃ ´ ～ ˇ ˘ ˝ ˚ ˙ ¸ ˛ ¡ ¿ ː ∮∑ ∏ ¤ ℉ ‰ ◁ ◀ ▷ ▶ ♤ ♠ ♡ ♥ ♧ ♣ ⊙ ◈ ▣ ◐ ◑ ▒ ▤ ▥ ▨ ▧ ▦ ▩ ♨☏☎☜☞ ¶ † ‡ ↕ ↗ ↙ ↖ ↘ ♭ ♩ ♪ ♬ ㉿㈜№㏇ ™ ㏂㏘℡ € ®

098*

031*

4

1

028* 030*

3

0

229*

가각간갇갈갉갊감갑 값갓갔강갖갗같갚갛개 객갠갤갬갭갯갰갱갸갹 갼걀걋걍걔걘걜거걱건 걷걸걺검겁것겄겅겆겉 겊겋게겐겔겜겝겟겠겡 겨격겪견겯결겸겹겻겼 경곁계곈곌곕곗고곡곤 곧골곪곬곯곰곱곳공곶 과곽관괄괆 괌괍괏광괘괜괠괩괬 괭괴괵괸괼굄굅굇굉교 굔굘굡굣구국군굳굴굵 굶굻굼굽굿궁궂궈궉권 궐궜궝궤궷귀귁귄귈귐 귑귓규균귤그극근귿글 긁금급긋긍긔기긱긴긷 길긺김깁깃깅깆깊까깍 깎깐깔깖깜깝깟깠깡깥 깨깩깬깰깸

230* 231* 232* 233*

23

234* 235* 236* 237* 238* 239* 240* 241* 242* 243*

24

244* 245* 246* 247* 248* 249*

0

1

2

3

4

5

6

7

8

9

깹깻깼깽꺄꺅꺌꺼꺽 꺾껀껄껌껍껏껐껑께껙 껜껨껫껭껴껸껼꼇꼈꼍 꼐꼬꼭꼰꼲꼴꼼꼽꼿꽁 꽂꽃꽈꽉꽐꽜꽝꽤꽥꽹 꾀꾄꾈꾐꾑꾕꾜꾸꾹꾼 꿀꿇꿈꿉꿋꿍꿎꿔꿜꿨 꿩꿰꿱꿴꿸뀀뀁뀄뀌뀐 뀔뀜뀝뀨끄끅끈끊끌끎 끓끔끕끗끙 끝끼끽낀낄낌낍낏낑 나낙낚난낟날낡낢남납 낫났낭낮낯낱낳내낵낸 낼냄냅냇냈냉냐냑냔냘 냠냥너넉넋넌널넒넓넘 넙넛넜넝넣네넥넨넬넴 넵넷넸넹녀녁년녈념녑 녔녕녘녜녠노녹논놀놂 놈놉놋농높놓놔놘놜놨 뇌뇐뇔뇜뇝 뇟뇨뇩뇬뇰뇹뇻뇽누 눅눈눋눌눔눕눗눙눠눴 눼뉘뉜뉠뉨뉩뉴뉵뉼늄 늅늉느늑는늘늙늚늠늡 늣능늦늪늬늰늴니닉닌 닐닒님닙닛닝닢다닥닦 단닫달닭닮닯닳담답닷 닸당닺닻닿대댁댄댈댐 댑댓댔댕댜더덕덖던덛 덜덞덟덤덥 덧덩덫덮데덱덴델뎀 뎁뎃뎄뎅뎌뎐뎔뎠뎡뎨 뎬도독돈돋돌돎돐돔돕 돗동돛돝돠돤돨돼됐되 된될됨됩됫됴두둑둔둘 둠둡둣둥둬뒀뒈뒝뒤뒨 뒬뒵뒷뒹듀듄듈듐듕드 득든듣들듦듬듭듯등듸 디딕딘딛딜딤딥딧딨딩 딪따딱딴딸 땀땁땃땄땅땋때땍땐 땔땜땝땟땠땡떠떡떤떨 떪떫떰떱떳떴떵떻떼떽 뗀뗄뗌뗍뗏뗐뗑뗘뗬또 똑똔똘똥똬똴뙈뙤뙨뚜 뚝뚠뚤뚫뚬뚱뛔뛰뛴뛸 뜀뜁뜅뜨뜩뜬뜯뜰뜸뜹 뜻띄띈띌띔띕띠띤띨띰 띱띳띵라락란랄람랍랏 랐랑랒랖랗 래랙랜랠램랩랫랬랭 랴략랸럇량러럭런럴럼 럽럿렀렁렇레렉렌렐렘 렙렛렝려력련렬렴렵렷 렸령례롄롑롓로록론롤 롬롭롯롱롸롼뢍뢨뢰뢴 뢸룀룁룃룅료룐룔룝룟 룡루룩룬룰룸룹룻룽뤄 뤘뤠뤼뤽륀륄륌륏륑류 륙륜률륨륩 륫륭르륵른를름릅릇 릉릊릍릎리릭린릴림립 릿링마막만많맏말맑맒 맘맙맛망맞맡맣매맥맨 맬맴맵맷맸맹맺먀먁먈 먕머먹먼멀멂멈멉멋멍 멎멓메멕멘멜멤멥멧멨 멩며멱면멸몃몄명몇몌 모목몫몬몰몲몸몹못몽 뫄뫈뫘뫙뫼


10. PREPARATION Code 250* 251* 252* 253*

25

254* 255* 256* 257* 258* 259* 260* 261* 262* 263*

26

264* 265* 266* 267* 268* 269* 270* 271* 272* 273*

27

274* 275* 276* 277* 278* 279* 280* 281* 282* 283*

28

284* 285* 286* 287* 288* 289* 290* 291* 292* 293*

29

294* 295* 296* 297* 298* 299* 300* 301* 302* 303*

30

304* 305* 306* 307* 308* 309* 310* 311* 312* 313*

31

314* 315* 316* 317* 318* 319*

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1

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3

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5

6

7

8

9

묀묄묍묏묑묘묜묠묩 묫무묵묶문묻물묽묾뭄 뭅뭇뭉뭍뭏뭐뭔뭘뭡뭣 뭬뮈뮌뮐뮤뮨뮬뮴뮷므 믄믈믐믓미믹민믿밀밂 밈밉밋밌밍및밑바박밖 밗반받발밝밞밟밤밥밧 방밭배백밴밸뱀뱁뱃뱄 뱅뱉뱌뱍뱐뱝버벅번벋 벌벎범법벗 벙벚베벡벤벧벨벰벱 벳벴벵벼벽변별볍볏볐 병볕볘볜보복볶본볼봄 봅봇봉봐봔봤봬뵀뵈뵉 뵌뵐뵘뵙뵤뵨부북분붇 불붉붊붐붑붓붕붙붚붜 붤붰붸뷔뷕뷘뷜뷩뷰뷴 뷸븀븃븅브븍븐블븜븝 븟비빅빈빌빎빔빕빗빙 빚빛빠빡빤 빨빪빰빱빳빴빵빻빼 빽뺀뺄뺌뺍뺏뺐뺑뺘뺙 뺨뻐뻑뻔뻗뻘뻠뻣뻤뻥 뻬뼁뼈뼉뼘뼙뼛뼜뼝뽀 뽁뽄뽈뽐뽑뽕뾔뾰뿅뿌 뿍뿐뿔뿜뿟뿡쀼쁑쁘쁜 쁠쁨쁩삐삑삔삘삠삡삣 삥사삭삯산삳살삵삶삼 삽삿샀상샅새색샌샐샘 샙샛샜생샤 샥샨샬샴샵샷샹섀섄 섈섐섕서석섞섟선섣설 섦섧섬섭섯섰성섶세섹 센셀셈셉셋셌셍셔셕션 셜셤셥셧셨셩셰셴셸솅 소속솎손솔솖솜솝솟송 솥솨솩솬솰솽쇄쇈쇌쇔 쇗쇘쇠쇤쇨쇰쇱쇳쇼쇽 숀숄숌숍숏숑수숙순숟 술숨숩숫숭 숯숱숲숴쉈쉐쉑쉔쉘 쉠쉥쉬쉭쉰쉴쉼쉽쉿슁 슈슉슐슘슛슝스슥슨슬 슭슴습슷승시식신싣실 싫심십싯싱싶싸싹싻싼 쌀쌈쌉쌌쌍쌓쌔쌕쌘쌜 쌤쌥쌨쌩썅써썩썬썰썲 썸썹썼썽쎄쎈쎌쏀쏘쏙 쏜쏟쏠쏢쏨쏩쏭쏴쏵쏸 쐈쐐쐤쐬쐰 쐴쐼쐽쑈쑤쑥쑨쑬쑴 쑵쑹쒀쒔쒜쒸쒼쓩쓰쓱 쓴쓸쓺쓿씀씁씌씐씔씜 씨씩씬씰씸씹씻씽아악 안앉않알앍앎앓암압앗 았앙앝앞애액앤앨앰앱 앳앴앵야약얀얄얇얌얍 얏양얕얗얘얜얠얩어억 언얹얻얼얽얾엄업없엇 었엉엊엌엎 에엑엔엘엠엡엣엥여 역엮연열엶엷염엽엾엿 였영옅옆옇예옌옐옘옙 옛옜오옥온올옭옮옰옳 옴옵옷옹옻와왁완왈왐 왑왓왔왕왜왝왠왬왯왱 외왹왼욀욈욉욋욍요욕 욘욜욤욥욧용우욱운울 욹욺움웁웃웅워웍원월 웜웝웠웡웨


Code 320* 321* 322* 323*

32

324* 325* 326* 327* 328* 329* 330* 331* 332* 333*

33

334* 335* 336* 337* 338* 339* 340* 341* 342* 343*

34

344* 345* 346* 347* 348* 349* 350* 351* 352* 353*

35

354* 355* 356* 357* 358* 359* 360* 361* 362* 363*

36

364* 365* 366* 367* 368* 369* 370* 371* 372* 373*

37

374* 375* 376* 377* 378* 379* 380* 381* 382* 383*

38

384* 385* 386* 387* 388* 389*

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2

3

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6

7

8

9

웩웬웰웸웹웽위윅윈 윌윔윕윗윙유육윤율윰 윱윳융윷으윽은을읊음 읍읏응읒읓읔읕읖읗의 읜읠읨읫이익인일읽읾 잃임입잇있잉잊잎자작 잔잖잗잘잚잠잡잣잤장 잦재잭잰잴잼잽잿쟀쟁 쟈쟉쟌쟎쟐쟘쟝쟤쟨쟬 저적전절젊 점접젓정젖제젝젠젤 젬젭젯젱져젼졀졈졉졌 졍졔조족존졸졺좀좁좃 종좆좇좋좌좍좔좝좟좡 좨좼좽죄죈죌죔죕죗죙 죠죡죤죵주죽준줄줅줆 줌줍줏중줘줬줴쥐쥑쥔 쥘쥠쥡쥣쥬쥰쥴쥼즈즉 즌즐즘즙즛증지직진짇 질짊짐집짓 징짖짙짚짜짝짠짢짤 짧짬짭짯짰짱째짹짼쨀 쨈쨉쨋쨌쨍쨔쨘쨩쩌쩍 쩐쩔쩜쩝쩟쩠쩡쩨쩽쪄 쪘쪼쪽쫀쫄쫌쫍쫏쫑쫓 쫘쫙쫠쫬쫴쬈쬐쬔쬘쬠 쬡쭁쭈쭉쭌쭐쭘쭙쭝쭤 쭸쭹쮜쮸쯔쯤쯧쯩찌찍 찐찔찜찝찡찢찧차착찬 찮찰참찹찻 찼창찾채책챈챌챔챕 챗챘챙챠챤챦챨챰챵처 척천철첨첩첫첬청체첵 첸첼쳄쳅쳇쳉쳐쳔쳤쳬 쳰촁초촉촌촐촘촙촛총 촤촨촬촹최쵠쵤쵬쵭쵯 쵱쵸춈추축춘출춤춥춧 충춰췄췌췐취췬췰췸췹 췻췽츄츈츌츔츙츠측츤 츨츰츱츳층 치칙친칟칠칡침칩칫 칭카칵칸칼캄캅캇캉캐 캑캔캘캠캡캣캤캥캬캭 컁커컥컨컫컬컴컵컷컸 컹케켁켄켈켐켑켓켕켜 켠켤켬켭켯켰켱켸코콕 콘콜콤콥콧콩콰콱콴콸 쾀쾅쾌쾡쾨쾰쿄쿠쿡쿤 쿨쿰쿱쿳쿵쿼퀀퀄퀑퀘 퀭퀴퀵퀸퀼 큄큅큇큉큐큔큘큠크 큭큰클큼큽킁키킥킨킬 킴킵킷킹타탁탄탈탉탐 탑탓탔탕태택탠탤탬탭 탯탰탱탸턍터턱턴털턺 텀텁텃텄텅테텍텐텔템 텝텟텡텨텬텼톄톈토톡 톤톨톰톱톳통톺톼퇀퇘 퇴퇸툇툉툐투툭툰툴툼 툽툿퉁퉈퉜 퉤튀튁튄튈튐튑튕튜 튠튤튬튱트특튼튿틀틂 틈틉틋틔틘틜틤틥티틱 틴틸팀팁팃팅파팍팎판 팔팖팜팝팟팠팡팥패팩 팬팰팸팹팻팼팽퍄퍅퍼 퍽펀펄펌펍펏펐펑페펙 펜펠펨펩펫펭펴편펼폄 폅폈평폐폘폡폣포폭폰 폴폼폽폿퐁

Code 390* 391* 392* 393*

39

394* 395* 396* 397* 398* 399* 400* 401* 402* 403*

40

404* 405* 406* 407* 408* 409*

0

1

2

3

4

5

6

7

8

9

퐈퐝푀푄표푠푤푭푯 푸푹푼푿풀풂품풉풋풍 풔풩퓌퓐퓔퓜퓟퓨퓬퓰 퓸퓻퓽프픈플픔픕픗피 픽핀필핌핍핏핑하학한 할핥함합핫항해핵핸핼 햄햅햇했행햐향허헉헌 헐헒험헙헛헝헤헥헨헬 헴헵헷헹혀혁현혈혐협 혓혔형혜혠 혤혭호혹혼홀홅홈홉 홋홍홑화확환활홧황홰 홱홴횃횅회획횐횔횝횟 횡효횬횰횹횻후훅훈훌 훑훔훗훙훠훤훨훰훵훼 훽휀휄휑휘휙휜휠휨휩 휫휭휴휵휸휼흄흇흉흐 흑흔흖흗흘흙흠흡흣흥 흩희흰흴흼흽힁히힉힌 힐힘힙힛힝

10

10.15

Manual Cardiofax 1150

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