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Biolight Meditech E30 Manual

Digital electrocardiograph
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Product Information
Product Model:
Product Name:
Manufacturer Name:
Contact Information:
Address: No.2 Innovation First Road, Technical Innovation Coast,
Post code: 519085
Fax: +86-756-339919
Toll-free consultation hot line: +86-400-8818-233
Revision History
This manual has a revision number. This revision number changes
whenever the manual is updated due to software or technical specification
change. Contents of this manual are subject to change without prior notice.
Document No.: J/E30CE-A-009
Revision number: V1.0
Release time: June.2013
Copyright © 2013 Guangdong Biolight Meditech Co., Ltd. All rights
reserved.
CE mark
EC Representative Name:
Shanghai International Trading Corp. GmbH (Hamburg)
EC Representative Address:
Eiffestrasse 80, 20537 Hamburg Germany
E30
Digital Electrocardiograph
Guangdong Biolight Meditech Co., Ltd.
Hi-Tech Zone Zhuhai, P.R. China
I

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Summary of Contents for Biolight Meditech E30

  • Page 1 Contents of this manual are subject to change without prior notice. Document No.: J/E30CE-A-009 Revision number: V1.0 Release time: June.2013 Copyright © 2013 Guangdong Biolight Meditech Co., Ltd. All rights reserved. CE mark EC Representative Name: Shanghai International Trading Corp. GmbH (Hamburg)

  • Page 2: Manufacturer's Responsibility

    Statement Manufacturer holds the copyright of this manual, and we are also entitled to deal with this manual as confidential files. This manual is only used for operation, maintenance and service of product, someone else can not publish the manual. This manual contains exclusive information protected by copyright laws and we reserve its copyright.
  • Page 3 required for monitoring patients. All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your product. Conventions: Bold Italic text is used in this manual to quote the referenced chapter or sections.
  • Page 4 〈This page is blank〉...

  • Page 5: Table Of Contents

    Content Chapter 1. General Introduction ..............1-1 1.1 Intended use ....................... 1-1 1.2 Contraindications ....................... 1-1 1.3 Manufacture Config ....................1-1 1.4 Main Unit ........................1-2 1.5 Screen Display ......................1-4 1.6 Equipment Sign ......................1-6 Chapter 2. Safety ....................2-1 2.1 Safety Information .....................
  • Page 6 6.1 Introduction ....................... 6-1 6.2 Optimizing Battery Performance ................6-1 6.3 Checking Battery Performance ................... 6-2 6.4 Disposing Batteries ....................6-2 Chapter 7. Clean and Maintenance ..............7-1 7.1 Summarize ......................... 7-1 7.2 Cleaning of the Electrocardiograph ................7-2 7.3 Cleaning and Sterilizing of Accessories ..............7-2 7.4 Cleaning and Maintenance of Recorder ..............
  • Page 7 D.8 Arrhythmias ........................ 15 D.9 Diagnosis Result ......................17 D.10 Movement Test ......................17 D.11 Datum Value ......................18 Appendix E Measurement .................. 19 E.1 The Waveform Boundaries of 12 Leads ............... 19 E.2 Measurements of One Beat ..................20 E.3 Isoelectric Segments ....................
  • Page 8 <This page is blank> VIII...

  • Page 9: Chapter 1.General Introduction

    E30 Digital Electrocardiograph User’s Manual Chapter 1.General Introduction 1.1 Intended use Electrocardiograph is applicable to medical units for patients’ ECG collection and providing of accurate measurement values. It can conduct data saving, review, display and recording of the ECGs. Electrocardiograph must be used under guidance of professionals, and is not suitable for family use.

  • Page 10: Main Unit

    E30 Digital Electrocardiograph User’s Manual 1.4 Main Unit 1.4.1 Top View Paper bin Indicating open button lamp Recorder Function button area AC power switch Direction and confirm button Indicating lamp NO. Name Note AC power Green light turns on if with AC power.
  • Page 11 E30 Digital Electrocardiograph User’s Manual Function button Name Note Press to enter the main menu interface. Menu button Press to switch the current working mode. Working mode switch button Press to adjust the ECG waveform gain. Waveform gain select button Press to adjust the bandwidth of filter.

  • Page 12: Screen Display

    E30 Digital Electrocardiograph User’s Manual NO. Name Note AC mains socket Connect to AC power Equipotent Connect to the Equipotential grounding grounding terminal system of hospital Patient cable socket Connect to patient cable USB connector Standard USB connector SD memory card slot Can be inserted SD memory card 1.4.4 Back View...
  • Page 13 E30 Digital Electrocardiograph User’s Manual Display Note Including: saving medium prompt, battery capability System info area indicator, AC power on/off prompt and network access prompt. The current time of the system is displayed. In the Current time system setup, the current time and display format may be set.

  • Page 14: Equipment Sign

    E30 Digital Electrocardiograph User’s Manual Display Note Press to select the lead number on screen display. 12-Lead 3-Lead, 6-Lead, 12-Lead is optional. Menu Press to enter the main menu. 1.6 Equipment Sign Sign Note Sign Note CE mark Dangerous voltage...

  • Page 15: Chapter 2.Safety

    E30 Digital Electrocardiograph User’s Manual Chapter 2.Safety 2.1 Safety Information Warning: Before putting the system into operation, verify that the Cardiograph, connecting cables and accessories are in correct working order and operating condition. Use only accessories specified by our company. Using other accessories may cause damage to the Cardiograph.
  • Page 16 E30 Digital Electrocardiograph User’s Manual exceed admit value. Please insure all electrodes connected and connect to the right position. Put electrodes and patient away from other electric parts and the earth. To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard.

  • Page 17: General Safety

    E30 Digital Electrocardiograph User’s Manual voltage and frequency ratings of the power cord are the same as those indicated on the cardiograph’s label or in this manual. Always install or carry the cardiograph properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.
  • Page 18 E30 Digital Electrocardiograph User’s Manual Cardiograph conforms to the safety requirements of IEC 60601-1:1988+ 2． A1:1991+A2:1995. This cardiograph is protected against defibrillation effects. Notes on symbols related to safety 3． Type CF applied part, defibrillation protected The unit displaying this symbol contains an F-Type isolated...

  • Page 19: Important Notes For Safety

    E30 Digital Electrocardiograph User’s Manual required by clinical use. Caution: The electrocardiograph does not contain any parts for self-repair by users. The repair of the instrument must be conducted by the technical personnel authorized by manufacturer. 2.3 Important Notes for Safety Patient Number The electrocardiograph can only be applied to one patient at one time.
  • Page 20 E30 Digital Electrocardiograph User’s Manual Do not use this equipment in the presence of flammable anesthetics, vapors or liquids. Leakage current test When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients.

  • Page 21: Safe Operation Conditions

    E30 Digital Electrocardiograph User’s Manual close patient observation or alternative monitoring devices should be used until electrocardiograph function is restored. If the electrocardiograph does not automatically resume operation within 60s, restart the electrocardiograph using the power switch. Once monitoring is restored, you should verify correct monitoring state and alarm function.
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  • Page 23: Chapter 3.Getting Started

    E30 Digital Electrocardiograph User’s Manual Chapter 3.Getting Started 3.1 Unpacking and Checking 1. Unpacking Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier. If the packing case is intact, open the package.

  • Page 24: Power Supply

    E30 Digital Electrocardiograph User’s Manual 3.2 Power Supply 3.2.1 AC Power Supply AC power: AC 100V-240V, 50Hz/60Hz. Take out the accessory power cord, and insert the plug of output end into the AC power socket at back panel of Electrocardiograph, and insert the...

  • Page 25: Placing Cables

    E30 Digital Electrocardiograph User’s Manual When many AC disturbances are found during test, the mode of battery power supply may be adopted to maintain the equipment operation. In this way, the impact of AC disturbances may be reduced. For the power supply period of battery, see the product specification.
  • Page 26 E30 Digital Electrocardiograph User’s Manual Electrode Electrode Electrode Electrode colors colors labels Labels Position (IEC) (AAMI) (IEC) Right leg (On crus, midpoint Black Green between knee and ankle.) Left leg (On crus, midpoint Green between knee and ankle) On the fourth intercostal space...
  • Page 27 E30 Digital Electrocardiograph User’s Manual Please refer to the following steps at the time of connecting chest electrodes: 1. Check whether the electrodes are clean and intact; 2. Clear up lead wire to avoid twisting, and firmly connect the electrode connector to electrodes;...

  • Page 28: Install The Chart Paper

    E30 Digital Electrocardiograph User’s Manual 3.5 Install the chart paper When the chart paper is not installed or is used up, “no paper” will be shown on the screen of Electrocardiograph to remind the users of installing or replacing the chart paper. Refer to the following steps during installation.

  • Page 29: Inspecting Before Starting

    E30 Digital Electrocardiograph User’s Manual 4) Close the paper pin, you will hear a sound of “ka” which indicates the recorder box is well closed and the installation is completed. Caution: The storage of chart paper shall meet the following...
  • Page 30 E30 Digital Electrocardiograph User’s Manual 6. Recording paper Please check the recording paper enough and be putted right. 7. Patient Make sure patient doesn’t contact the metal part of the bed, the room condition is comfortable and the patient is relaxed. Ask the patient to release...

  • Page 31: Chapter 4.Operation Instruction

    E30 Digital Electrocardiograph User’s Manual Chapter 4.Operation Instruction 4.1 Turn On/Off Using AC power supply: ——Turn on: Press the power button after connecting the power cord, the screen displays the start interface, and then enter work mode. ——Turn off: Press power button, and screen will display “The device is shutting off…”, when the prompt info is over, the device is power off.

  • Page 32: Patient Info Setup

    E30 Digital Electrocardiograph User’s Manual Fig.4-1: Main Menu 4.3 Patient Info Setup Press 【New patient】 in main menu to enter patient info setup interface. Shown as following chart: Fig.4-2: Patient info setting In the interface, you may conduct the following operations: ——【ID】: Input patient ID.

  • Page 33: File Management

    E30 Digital Electrocardiograph User’s Manual 4.4 File Management 4.4.1 File Management Interface Electrocardiograph can store and manage more than 300 shares of patient data. It can review, edit, record, delete or transmit patient data in file management window. Data stored including the ECG waveform, analyze conclusion and ECG report with patient info.
  • Page 34 E30 Digital Electrocardiograph User’s Manual 4.4.2 File Review After choosing a patient data in file management interface, Press 【Review】 can enter the following file review interface. Fig.4-4: File Review--Waveform In the interface, you can select 【Wave】 or 【Text】 to review the waveform or text info.

  • Page 35: Work Mode Setup

    E30 Digital Electrocardiograph User’s Manual Fig.4-7: File Review--Text display (Diagnose Info) In the figure4-4 to 4-7, you may conduct the following operations: ——Select【Edit】: Can change patient info saved in file. ——Select【Record】: Can record the current ECG report. ——Select【Return】:Back to the previous interface.

  • Page 36: Auto Mode

    E30 Digital Electrocardiograph User’s Manual Rhythm mode. In this interface, you can set the parameters of Auto style, Manual style, Rhythm style and Rhythm leads. Shown as following chart: Fig.4-9: Work Mode Setup 4.5.1 Auto Mode During ECG recording in Auto mode, the lead group will switch over automatically in order, i.e.

  • Page 37: Rhythm Mode

    E30 Digital Electrocardiograph User’s Manual Operating refers to the following steps: 1. Before recording, enter the patients’ info. 2. Press “ ” on the panel to switch the working mode into Manual mode. 3. After select 【Work Mode】 in main interface, you can select 【Manual style】...

  • Page 38: Filter Setup

    E30 Digital Electrocardiograph User’s Manual patient or the cables is well connected with machine. If message still exists, maybe there is a broken circuit within patient cable, please replace the cable with a new one. 4.6 Filter Setup Set the filter parameters of Electrocardiograph in order to improve the ECG anti-disturbance performance.

  • Page 39: Report Info Setup

    E30 Digital Electrocardiograph User’s Manual to turn off the AC filter. ——Select【DFT filter】: Select On/Off to turn on/off the baseline drift filter. When the unstability of baseline is found, it is suggested to open the baseline drift filter in order to eliminate the drift of baseline or the other interference...

  • Page 40: System Setup

    E30 Digital Electrocardiograph User’s Manual of system after recording of a patient. ——Select【Default medium】: May select one auto save medium according to actual needs, i.e. Flash, SD card or U disk. ——Select【Measure】: May select 【Display】 or 【Not display】. Result of the ECG waveform measurement will be exported while selecting 【Display】, otherwise, it will not.
  • Page 41 E30 Digital Electrocardiograph User’s Manual Fig.4-12: System Setup In the interface, you may conduct the following operations: ——Select 【 Lead name 】 : May select lead name displayed. Optional: 【AAMI】 or 【IEC】. ——Select【LCD off delay】: Set the automatic shut-off time of LCD of Electrocardiograph.
  • Page 42 E30 Digital Electrocardiograph User’s Manual Note: When 【Power off delay】 or 【LCD off delay】 is off, both of the functions are useless. The electrocardiograph will enter into the status of “standby” or “power off” if the device is not been used within the preset time of 【LCD off delay】...

  • Page 43: Chapter 5.Read The Printed Ecg Report

    E30 Digital Electrocardiograph User’s Manual Chapter 5.Read the Printed ECG Report This chapter describes the printed report of the Electrocardiograph in each mode. The chart below is the ECG report of Auto 3×4+1 in Auto mode: 1 mV calibration signal...
  • Page 44 E30 Digital Electrocardiograph User’s Manual The chart below is the ECG report of Auto 3-2+1 in Auto mode: 1 mV calibration signal Rhythm lead Record speed Wave gain DFT filter (On) Waveform info Lowpass frequency Work mode and report format...
  • Page 45 E30 Digital Electrocardiograph User’s Manual In manual mode, real-time recording of ECG waveform is conducted manually according to the requirements of users, and start and stop of recording are controlled via keys. Optional: Manual 1(display waveform of lead Ⅰ Ⅲ), Manual 2(display waveform of lead aVR~aVF), Manual 3(display waveform of lead V1~V3), Manual 4(display waveform of lead V4~V6).
  • Page 46 E30 Digital Electrocardiograph User’s Manual In Rhythm mode, specific lead rhythm is analyzed. Optional: single-rhythm lead mode and 3-rhythm lead mode. The chart below is the ECG report of 3-rhythm lead in Rhythm mode: 1 mV calibration signal Timing info...
  • Page 47 E30 Digital Electrocardiograph User’s Manual Report info in each mode is different, the description hereinafter is being written according to the most comprehensive info. A. Patient info contains: Patient number (ID), name, age, gender, height, weight, blood pressure, race, room number and medicine in use.
  • Page 48 E30 Digital Electrocardiograph User’s Manual If missing of check of R wave is caused by some lead fall-off and QRS low voltage, the measurement of HR will possibly have big error. In case of QRS low voltage, the calculation of ECG axis and the dividing point identification of QRS wave are unreliable sometimes.

  • Page 49: Chapter 6.Battery

    E30 Digital Electrocardiograph User’s Manual Chapter 6.Battery 6.1 Introduction The electrocardiograph can be fitted with rechargeable battery to ensure its continuous work after the failure of alternating current power supply, and the battery needs no special maintenance under the normal condition. While the...

  • Page 50: Checking Battery Performance

    E30 Digital Electrocardiograph User’s Manual once when it is used or stored for two months, or when its run time becomes noticeably shorter. To optimize a battery, follow this procedure: 1. Disconnect the electrocardiograph from the patient and stop all monitoring and measuring procedures.
  • Page 51 E30 Digital Electrocardiograph User’s Manual Warning: Do not random remove battery, place battery at a place with open flame or cause short circuit of battery. Combustion or explosion of battery or leak of battery electrolyte is possible to result in personal injuries.
  • Page 52 E30 Digital Electrocardiograph User’s Manual <This page is blank>...

  • Page 53: Chapter 7.Clean And Maintenance

    E30 Digital Electrocardiograph User’s Manual Chapter 7.Clean and Maintenance 7.1 Summarize Keep your equipment and accessories free of dust and dirt. To avoid damage to the equipment, follow these rules: 1. Always dilute according the manufacturer’s instructions or use lowest possible concentration.

  • Page 54: Cleaning Of The Electrocardiograph

    E30 Digital Electrocardiograph User’s Manual 7.2 Cleaning of the Electrocardiograph Common detergent and non-corrosive disinfectant used in hospital can be applied to clean electrocardiograph, however you must be aware that many kinds of detergents must be diluted prior to utilization, and please use it according to the instruction of detergent manufacturer.
  • Page 55 E30 Digital Electrocardiograph User’s Manual e) Air dries the cable at a shady and cool place. Caution: It is necessary to regularly check the cable and lead wire of the patient to ensure their completeness and good conduction; Damaged or aging cable or wire shall be replaced timely;...

  • Page 56: Cleaning And Maintenance Of Recorder

    E30 Digital Electrocardiograph User’s Manual Caution: Disinfection possibly causes damage to Electrocardiograph to some extent. It is suggested that disinfection be conducted only when your hospital maintenance plan deems it as necessary. The equipment shall be cleaned before disinfection. Note: Electric schematic diagram and list of components are provided to the qualified maintenance station or personnel certified by the manufacturer only.

  • Page 57: Chapter 8.Accessories

    E30 Digital Electrocardiograph User’s Manual Chapter 8.Accessories Warning: Use only accessories specified in this manual. Using other accessories may cause damage to the electrocardiograph. Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected.
  • Page 58 E30 Digital Electrocardiograph User’s Manual 15 PIN Type AAMI With 10K defibrillation enhanced integrated 1.15.52-0036-01-00 resistance 12-lead ECG cable 15 PIN Type IEC With 10K defibrillation enhanced integrated 1.15.52-0036-02-00 resistance 12-lead ECG cable...

  • Page 59: Appendix A Product Specifications

    E30 Digital Electrocardiograph User’s Manual Appendix A Product Specifications A.1 Safety Specifications According to the MDD 93/42/EEC, the electrocardiograph is Type Ⅱa equipment. Classified according to the IEC60601-1 is as follows: Class I, internally and externally powered equipment. Classification of...

  • Page 60: Physical Specifications

    E30 Digital Electrocardiograph User’s Manual A.3 Physical Specifications 315mm × 215mm × 75mm Size (W×H×D) 1.6 Kg Weight 4.3″, 480×272 TFT LCD Display A.4 Power Specifications A.4.1 AC Power 100V-240V AC Rated Voltage 50Hz/60Hz Rated Frequency 80VA Rated Power Comply with IEC 60601-1 and IEC 60601-1-2 Standard A.4.2 DC Power（Built-in battery）...

  • Page 61: Hardware Specifications

    E30 Digital Electrocardiograph User’s Manual A.5 Hardware Specifications A.5.1 Recorder Thermal dot array Recording way Horizontal resolution 40 dots/mm (25mm/s) 8 dots/mm Vertical resolution 5 mm/s, 6.25 mm/s, 10 mm/s, 12.5 mm/s, 25 mm/s, 50 Recording speed mm/s, error:±3%. ≤0.5mm/30M...

  • Page 62: Display Of Ecg Collection

    E30 Digital Electrocardiograph User’s Manual Coding of diagnosis Coding of diagnosis info (Factory default) info Diagnosis analyze ≥140 kinds category A.7 Display of ECG Collection 12-Lead, defibrillator-proof, Pacemaker pulse rejection Signal input Degree of protection 4000V, Type CF applied part...

  • Page 63: Input/Output Specification

    E30 Digital Electrocardiograph User’s Manual 5000V 360J Recovering time for defibrillator-proof ≤5 s Recovering time for defibrillator electrode polarization Defibrillator-proof ≤10 s Energy reduced ≤10% Voltage transfer ≤1V A.8 Input/Output Specification 6 function keys, 4 direction keys, 1confirm key, 1 power...
  • Page 64 E30 Digital Electrocardiograph User’s Manual Software can be upgraded by means of USB flash disk; Maintenance function Software function configuration is allowed. Data saving of SD card and USB flash disk is supported; Storage function Transfer, import and export of data are allowed.

  • Page 65: Appendix B Factory Default Setting

    E30 Digital Electrocardiograph User’s Manual Appendix B Factory Default Setting This chapter lists some important factory default settings of electrocardiograph. Users can not change them, but electrocardiograph can be recovered to factory default setting according to actual need. Item Factory Default Setting...
  • Page 66 E30 Digital Electrocardiograph User’s Manual <This page is blank>...

  • Page 67: Appendix C Prompt Information

    E30 Digital Electrocardiograph User’s Manual Appendix C Prompt Information Prompt information Cause No paper Chart paper is not installed or chart paper is used up Roller not in place Rubber stick is not been well pressed Print head overheating Print head of recorder is overheating Demo The system is in demonstration status.
  • Page 68 E30 Digital Electrocardiograph User’s Manual <This page is blank>...

  • Page 69: Appendix D Diagnosis Info Mark

    E30 Digital Electrocardiograph User’s Manual Appendix D Diagnosis Info Mark D.1 Otherwise Diagnosis Terms Info Mark Unsatisfactory Record Limb leads Reversed? Counter Clock Wise Rotation Clock Wise Rotation Low Voltage (Limb Leads) Low Voltage (Chest Leads) Low Voltage QT Prolongation...

  • Page 70: Ventricular Hypertrophy And Atrial Enlargement

    E30 Digital Electrocardiograph User’s Manual D.3 Ventricular Hypertrophy and Atrial Enlargement Diagnosis Terms Info Mark High Voltage (Left Ventricle) Positive T in V1 Right Ventricular Hypertrophy? (RVH) Left Ventricular Hypertrophy? (LVH) LVH? (Probably Normal for This Age) Right Ventricular Hypertrophy...

  • Page 71: Ventricular Conduction Block

    E30 Digital Electrocardiograph User’s Manual Diagnosis Terms Info Mark WPW Syndrome? WPW Syndrome (A)? WPW Syndrome (B)? PR Prolongation AV Block 2 (Wenckebach) AV Block 2 (Mobitz) 2:1 AV Block Complete AV Block Artificial Pacemaker Rhythm (A) Artificial Pacemaker Rhythm (V)

  • Page 72: St-T Morphology Statements

    E30 Digital Electrocardiograph User’s Manual Diagnosis Terms Info Mark ICLBBB (Incomplete Left Bundle Branch Block) Suspect Left Anterior Hemi Block LAH (Left Anterior Hemi Block) LPH (Left Posterior Hemi Block) BBBB (Bifascicular Bundle Block) TBBB (Trifascicular Bundle Block) Peri-Infarction Block D.6 ST-T Morphology Statements...

  • Page 73: Arrhythmias

    E30 Digital Electrocardiograph User’s Manual Diagnosis Terms Info Mark Anterior Infarction Anterior Infarction (possibly recent) Anterior Infarction (possibly acute) Suspect Anteroseptal Infarction? Possible Anteroseptal Infarction Anteroseptal Infarction Anteroseptal Infarction (possibly recent) Suspect Lateral Infarction? Possible Lateral Infarction Lateral Infarction Lateral Infarction (possibly recent)
  • Page 74 E30 Digital Electrocardiograph User’s Manual Diagnosis Terms Info Mark Suspect Left Atrial Rhythm? AV junctional Rhythm AV Dissociation Marked Sinus Bradycardia Sinus Bradycardia Sinus Tachycardia Tachycardia Bradycardia Extreme Tachycardia Extreme Bradycardia Sinus Arrhythmia Escape Beat PAC (Premature Atrial Construction) Frequent PAC...

  • Page 75: Diagnosis Result

    E30 Digital Electrocardiograph User’s Manual Diagnosis Terms Info Mark PVC (RonT) SA Block or Marked Sinus Arrhythmia Blocked PAC Supraventricular Tachycardia Ventricular Tachycardia Ventricular Escape Rhythm Ventricular Rhythm Atrial Fibrillation Atrial Flutter Ventricular Fibrillation Undefined Arrhythmia D.9 Diagnosis Result Diagnosis...

  • Page 76: Datum Value

    E30 Digital Electrocardiograph User’s Manual D.11 Datum Value Datum value used for classification of Minnesota Code and diagnosis information is based on age and gender according two methods as following: (1) a (b1, b2) c d Age of the male or the female not less than 19 years old...

  • Page 77: Appendix E Measurement

    E30 Digital Electrocardiograph User’s Manual Appendix E Measurement One predominant beat is selected from each 12 leads waveform. The 12 predominant beats are used to locate the waveform boundaries (the onsets and ends of P, QRS, T wave) in multilead ECG signal (the 12 standard leads) and measure features of clinical importance (such as the amplitude and duration of the Q, R, S, R’...

  • Page 78: Measurements Of One Beat

    E30 Digital Electrocardiograph User’s Manual E.2 Measurements of One Beat Parameter Description Measurement unit Amplitude of the P wave Amplitude of the P’ wave P’a (in case of biphasic P wave) Amplitude of the Q wave Amplitude of the R wave Amplitude of the S wave R’a...

  • Page 79: Stability Of Measurements Against Noise

    E30 Digital Electrocardiograph User’s Manual E.4 Stability of Measurements against NOISE E.4.1 Acceptance of minimum waves The labeling of the QRS waveforms depends by definition (since Einthoven) on the first detected wave. A tiny positive wave at QRS beginning is called r or R and may mask a true, following Q wave.

  • Page 80: Disclosed Changes Of Measurments Caused By Noise On Ecgs

    E30 Digital Electrocardiograph User’s Manual E.4.2 Disclosed changes of measurments caused by NOISE on ECGs Disclosed differences Global Type of added Mean (ms) Standard deviation Remark measurement NOISE High 50Hz P-duration 12.0 60Hz Baseline High -5.6 50Hz PR-interval 60Hz Baseline...

  • Page 81: Appendix F Guidance And Manufacturer's Declaration Of Emc

    Guidance and manufacture’s declaration – electromagnetic emission The E30 Digital Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of E30 Digital Electrocardiograph should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment –...
  • Page 82 Guidance and manufacture’s declaration – electromagnetic immunity The E30 Digital Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of E30 Digital Electrocardiograph should assure that it is used in such an environment. Electromagnetic environment -...
  • Page 83 Guidance and manufacture’s declaration – electromagnetic immunity The E30 Digital Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of E30 Digital Electrocardiograph should assure that it is used in such an environment. Compliance...
  • Page 84 RF communications equipment and the E30 Digital Electrocardiograph The E30 Digital Electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the E30 Digital Electrocardiograph can help prevent...
  • Page 85 Product name: Digital Electrocardiograph Product type: E30 Manufacturer: Guangdong Biolight Meditech Co., Ltd. Address: No.2 Innovation First Road, Technical Innovation Coast, Hi-Tech Zone Zhuhai, P.R. China Fax: +86-756-3399919 Post code: 519085 Toll-free consultation hot line: +86-400-8818-233 PN: 22-041-0012...

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