Handheld ECG Monitor
Contents
1. 31 14 General information about the Heart and ECG Measurements 32 V1 0B1 1 General Description 1 1 Know Your Device HANDHELD ECG MONITOR Description of Picture 1 POWER button Power on or off the device 2 Metal Electrodes Hold these two with right index finger when taking a measurement START button The shortcut key for ECG measurement OK button Press this button to confirm the selection or set date and time when in the Date and Time Setting Mode WP Button Press this button to move the cursor to your desired menu or change the number or move the wave form to the left lt VA Button Press this button to move the cursor to your desired menu or change the number or move the wave form to the right Picture 1 MENU button Return to the previous menu by pressing this button 8 Metal Electrodes Place this against the center of left palm or chest when taking a measurement QECG cable socket When taking measurement by ECG cable connect the ECG cable with this port USB interface Transmit data to the PC through this interface V1 0B1 HANDHELD ECG MONITOR 1 2 Product Features Small portable and easy to use completely cable free Choice of two measuring modes USB data transmission Fast measurement in just 30 seconds lt gt 200 records of ECG Strips each record with 30 second ECG wavefor2. 2 pieces 1 piece Instruction manual 1 piece Quick Operation Guide 1 piece Warranty card 1 piece Data cable 1 piece Data Management Software 1 piece Clamp Electrode optional Notes Specifications may be changed without prior notice Disposal of this product and used batteries should be carried out in accordance with the local regulations for the disposal of electronic products Please use the accessories of the equipment change another accessories may cause degrading the safety performance 28 V1 0B1 HANDHELD ECG MONITOR Appendix Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The Handheld ECG Monitor is intended for use in an electromagnetic environment special below The customer or the user of the this product should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic environment Test Test level Level guidance Electr
3. 2005 07 26 09 05 47 010 200 Measurement GRAPH Menu SET Menu Data Management gt Picture 2 Picture 3 Version e Measurement Enter this menu to select the measurement mode and take measurement LGRAPH Menu Enter this menu to review delete and lock the detected ECG waveform and analysis result SET Menu Enter this menu to set the Date amp Time Brightness Beeper Automatic Power off ID Setup and Wave Scale Data Management Enter this menu for selecting to erase the data Version Enter this menu to look over the monitor s information 2 Inserting and Replacing Batteries 2 1 Open the battery cover on the back panel of the device 2 2 Insert two AAA batteries lightly as indication of the polarity sign refer to Picture 4 Note Make sure the polarity of the batteries is correct Batteries cover Picture 4 23 Close the battery cover V1 0B1 HANDHELD ECG MONITOR A Make sure that the polarity of the batteries is correct Otherwise the device cannot operate normally Battery life and replacement When the Battery power is low please change with new ones timely message appears replace batteries with new ones lt Always turn off the device before replacing the batteries lt Dispose of the used batteries according to the applicable local regulations Battery life Two new AAA batteries will la
4. Set the ID number for different users Check the date and time are correct before using the device reset them if necessary The ID number date and time are important indicators when a measurement is taken 3 1 Date and time setting Note The date and time information will be displayed on the screen in format of Year Month Date Hour Minute Second 1 Press the Power button for 3 seconds to turn on the device Picture 6 2 Select the SET menu item as shown in 6126 010710 Picture 7 And then press the OK button to fH Measurement gt enter 1 GRAPH Menu f SET Menu amp Data Menagement gt Picture 7 Date and Time 3 Select the Date and Time item as shown in Brightness Picture 8 then press the OK button E Auto Powerof Picture 8 41 V1 0B1 HANDHELD ECG MONITOR 4 Press the OK button to select the item and press WD or 4 button to set the Date and Time values and then press the MENU c EIN button to confirm your settings e 4 gt lt 3 2 ID setting Picture 9 NOTE ALWAYS set different ID numbers for every user before taking a measurement 1 Press the WE Down or right button to select the SET menu And then press the OK button ID Setup to enter BD Wave Scale A User ID setting Picture 10 2 Pr
5. Note The ideal posture is one where you are seated comfortably with your back straight You can also take a measurement while you are standing or while lying down And be sure to keep still and do not move until the measurement is complete 4 3 Palm Measurement Make sure hold the 2 metal electrodes of the device with right index finger firmly and place the 9 electrodes against the center of the left palm Refer to Picture 15 Picture 15 2007 08 16 15 55 12 001 200 m 2 Picture 16 Description of Picture 16 2007 08 16 The current date 15 55 12 current time 001 200 It indicates one measurement has been saved in the monitor and the monitor can store up to 200 records doy Indication of the power of battery E ECG amplitude ruler AA The examined ECG waveform 14 V1 0B1 HANDHELD ECG MONITOR x1 ECG waveform scale You can select the displaying scale X 0 5 X 1 X 1 5 or X 2 in the SET Menu 2 Sign of speaker status The status bar of measurement progress 2 Indication of measurement time The sign of heartbeat it twinkles synchronously with the heart beat It takes about 30 seconds to complete the measurement During the measurement the device will beep synchronously along with the heart beat the screen displays the ECG waveform and progress bar at the bottom of the screen indicates measurement progress During measurement the screen
6. 15 55 The record storage time in term ID 021 The ID number The results will be stored automatically within 3 seconds The system can memorize 200 pieces of records at most When the records are full the icon 8 will appear on the upper right of the LCD screen shown as the Picture 19 amp Picture 20 17 08 16 09 07 34 199 200 2007 08 16 15 55 12 200 200 eh Measurement EB Measurement P DBO Storage is full 4 Srr menu amp Data Menagement gt 2007 08 16 15 55 1D 012 w System unit setting Cancel Picture 19 Picture 20 After you finish saving the 200th measurement result the system will remind you that the storage is full shown as Picture 19 after that If you want to store another record the system will remind you that the record can not be stored Shown as Picture 20 until the user deleted the unnecessary records 16 V1 0B1 HANDHELD ECG MONITOR Caution DO NOT use result for direct diagnostic or analytical decision but use it for reference ONLY Press the button for four seconds to turn off the device Note If you forget to turn the device off it will automatically shut down within one minute Users can set the auto power off time limit 1 minutes 2 minutes 10 minutes in System Settings 4 4 Chest measurement If palm measurement is not ideal please adopt chest measurement 4 4 1 Measurement for Male Hold the d
7. displays the ECG waveform and the progress bar at the bottom of the screen displays measurement progress Notes During measurement the device will only respond to the MENU or OK button to discontinue the measurement If the contact between the electrodes and skin becomes loose or the conditions change during measurement the measurement may be incorrect When the electrodes are contacted not well during the measurement the device will remind you with P icon at the bottom of the screen next to the icon Keep still and do not move until the measurement is complete Wrong Operation Methods A Both hands move at will B Both bands contact with the electrode loose during the measurement C No palm finger touches the electrode A measurement result message is displayed when the measurement has been completed refer to Picture 17 amp 18 for detail 15 V1 0B1 HANDHELD ECG MONITOR 2007 08 16 15 55 12 001 200 m bom Analyzing Stable waveform 2007 08 16 15 55 ID 012 Cancel Picture 17 Picture 18 Description of Picture 18 2007 08 16 The current date 15 55 12 The current time 001 200 It indicates one measurement has been saved in the monitor and the monitor can store up to 200 records d n Indication of the power of battery HR 080 bpm The heart rate is 80 beats per minute 2007 08 16 The record storage date
8. press the OK button to enter into the sub menu Refer to the following picture Picture 34 Press the OK button to confirm your selection and meanwhile return the previous menu 24 V1 0B1 HANDHELD ECG MONITOR Erase the data Erase all data ves E Erasing all data Picture 35 Press the OK button to confirm your selection and meanwhile return the previous menu 9 Data Transmission Before data transmission make sure that the device is on and connected with a computer by the data cable attached The operations refer to the accompanying Software User Manual 10 Version In the main menu press the WI gt button to select the Version you will get the information about monitor information Actually ECG arrhythmia analysis function is embedded in the device but this function could only be initiated with a register Code If arrhythmia analysis function is really in need please contact the local supplier for the Register Code Note The Register Code will be surcharged 11 Trouble Shooting The device can 1 The batteries are worn 1 Replace batteries with new ones NOT be turned out 2 Reinstall batteries with their on 2 The batteries are polarities correctly inserted incorrectly 3 Please contact the local service 3 The device might be center broken out 25 V1 0B1 The device is failure to measure heart rate ECG waveform unstable or
9. the measured field strength in the location in which the Handheld ECG monitor is used exceeds the applicable RF compliance level above the Handheld ECG monitor should be observed d 3 5 800MHZz to 2 5GH 35 JP z z Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the Handheld ECG monitor The Handheld ECG monitor is intended for use in an electromagnetic environment in which radiated RF disturbance is controlled The customer or the user of the MD100 Handheld ECG monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the Handheld ECG monitor as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m V1 0B1 HANDHELD ECG MONITOR maximum 450KHz to 80 MHz 80MHz to 800 MHz 800MHz to 2 5 GHz output power of V JP E VP transmitter W 0 1167 0 1167 0 2334 0 3689 0 3689 0 7378 1 1667 1 1667 2 3334 3 6893 3 6893 7 7386 100 11 6667 11 6667 23 3334 For transmitters rated at maximum output power not listed above the recommended separation distance in meters m can be estimated using the equation app
10. too much irrelevant waveforms 1 The electrodes are not made good contact with your body 2 Move when measuring 3 Electromagnetic interference 4 The signal is too weak 1 Your skin is dry 2 Electrode and the body does not contact well 3 Your body is too tense HANDHELD ECG MONITOR 1 Place the electrode correctly 2 Keep motionless and avoid moving when measuring 3 Keep away from electromagnetic interference 4 Change another measurement e g Chest Cable measurement method of 1 Cleaning skin with soap and water and moisten your skin with damp towel 2 Check the instructions and repeat measurement 3 Relax and repeat the measurement exist 12 Key Symbols The safe class of this device is type CF A Warnings Users should pay enough attention Symbol Record is locked Record is lull Heart rate Unit BPM beat Power button per minute Lead off i Low battery voltage Serial number USB interface The device is of ESD sensitivity Manufacturer s address 13 Technical Data Classification According to the type of protection against electric shock it can be classified as internally power equipment its application type is CF and it is the movable common 26 V1 0B1 HANDHELD ECG MONITOR facility with no defibrillator or protection Operating Environment Operation Temperature 5 C 40 C Atmosphere Pressure Range 86k
11. HANDHELD ECG MONITOR INSTRUCTION MANUAL Edition V1 0B1 V1 0B1 HANDHELD ECG MONITOR Copyright Our company owns all rights of this unpublished work and intends to maintain it as a confidential work We may also seek to maintain this work as an unpublished copyright This publication is to be used solely for the purpose of reference or operation of our software system No part of this work can be disseminated for other purposes In the event of inadvertent or deliberate publication we intend to enforce its right to this work under copyright laws as a published work Those having access to this work may not copy use or disclose the information in this work unless expressly authorized by our company All information contained in this publication is believed to be correct We shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this material The information this publication refers to is protected by copyrights or patents and does not convey any license under the patent rights of our company nor the rights of others We do not assume any liability arising out of any infringements of patents or other rights of third parties Contents of this manual are subject to changes without prior notice C This item is compliant with Medical Device Directive 93 94 EEC of 14 June 1993 a directive of the European Economic Community All right
12. Pa 106kPa Operation Humidity lt 80 no condensation Operation Voltage DC 3V 0 8V 0 8V 2 AAA batteries Storage Environment Storage Temperature 20 C 55 C Storage Humidity lt 93 no condensation ECG Measurement Channel amount 1 difference input Measuring electrodes Four integrative metal electrodes Three Measuring parts The signals measured can be lead between right and left hand and approximate II lead or III lead between the both hands and the chest Note The signals measured by the device positioned from the right hand and left hand is lead on a standard surface ECG The signals measured by the device positioned from the right hand and left chest best approximates a frontal plane lead such as lead standard surface ECG Signal bandwidth 0 5Hz 75Hz Sampling rate 250Hz Heart rate measuring range 30bpm 240bpm Heart rate measuring accuracy 30 100bpm 2bpm 101 240bpm 4bpm Display Mode Display screen type 160 x 240 dot matrix single color LCD The dimension of display area 70 45 Backlight LCD backlight Data Storage Every record stores ECG data for 30 seconds The device can store 200 items of ECG strips records at most 27 V1 0B1 HANDHELD ECG MONITOR Dimension and Weight Dimension 136mm x 84mm X 21mm Length x Width x Height Weight 120g Not including Two AAA batteries Product Accessories Batteries AAA
13. R tom YES Ng Stable waveform Lock 10 012 09 13 2007 08 16 Picture 27 In the current menu press the WP or lt VA button to select YES NO or the KEY icon and then press the OK button to reserve delete or lock the result Deleting or locking the ECG data record Deleting Under the Pic 27 menu press the W gt or lt button to select the YES item you will delete the current ECG records Locking Press the WP or lt VA button to select the KEY icon you will lock the current ECG records The locked record can NOT be deleted If you want to unlock the records select the KEY icon again and press the button 2007 08 16 15 55 12 007 200 m 1 a 078 012 k 2 2007 07 26 03 39 3 2007 07 25 23 28 4 2007 07 25 23 22 1 Picture 28 22 V1 0B1 HANDHELD ECG MONITOR 7 System Settings Select SET menu in the main menu by pressing the We button and press OK button to enter 7 1 ID Date and Time Setting Please refer to the section 3 Setting the Date and Time 7 2 Brightness Setting 7 2 1 Press the WE button to select the Brightness and then press the OK button to enter Press the WE button or lt to select the backlight level from or 1 2 3 7 and then press OK button to confirm the setting Refer to Pic 29 Picture 29 7 2 2 Press the OK button to confi
14. ate so be sure to check their position before taking a measurement After taking a measurement disinfect the electrodes by wiping them with a soft cloth or cotton swab moistened with disinfectant alcohol If you do not disinfect the electrodes there is a risk of skin disease Note If the contact of the electrodes become loose or the conditions change during measurement the measurement may not be correct 4 1 Press the O Power button for about 3 seconds to turn on the device Enter the menu interface as shown in Picture 12 and select the option Measurement item then the interface switches to the one as shown in Picture 13 Measurement M odes include Easy Mode and Continuous Mode Choose Easy Mode item then click OK button The interface will appear as shown in Picture 14 When the count down from six to zero the measurement starts 1005 07 26 0 05 47 010 200 D 2007 08 16 15 55 12 001 200 m 2007 08 03 18 01 54 016 200 Measurement 9 Measurement Mode r P GRAPH Menu gt E SET Menu gt MU 5 eee Eee F Continuous Mode Data Menagement gt Z _ _ L Me asureme Picture 12 Picture 13 Picture 14 13 V1 0B1 HANDHELD ECG MONITOR 4 2 Make sure that you are in a relaxed position Then press the START button to start a measurement and the measuring mode depends on your selection in Measurement menu
15. ess the WE Down or right button to select the ID Set up menu then press the OK button to enter into the ID Set up screen Then press the V A or WE button to set the ID number The ID number range is from 1 to 255 Picture11 4 Taking a Measurement The methods of measurement include palm measurement chest measurement and cable measurement The measurement modes include Easy Mode and Continuous Mode Important Notes on Taking a Measurement In order to obtain a good ECG reading it is important that measurements are taken correctly Please read the instructions carefully before taking a measurement for the first time and follow the instructions each time you take a measurement 12 V lt gt 1 0 1 HANDHELD ECG MONITOR Make sure that the electrodes are directly touching your skin If your hands or skin are dry wipe them with a damp towel so that they are slightly moist If the electrodes are dirty wipe any dirt off with a soft cloth moistened with disinfectant alcohol or a cotton swab Take care not to use too much disinfectant alcohol when cleaning the electrodes Do not wipe or get disinfectant alcohol on parts other than the electrodes Do not move during measurement Movement including talking coughing or sneezing during measurement can affect the measurement results If the position of your finger or arm is inappropriate during measurement the results may be inaccur
16. esults can be real timely displayed on a computer by the data transmission software after connecting the monitor with computer by the data cable 5 Measurement Results In the main menu interface press the Navigation button up or V down to select GRAPH Menu item then press the OK button you will see the description of the relative record as shown in Picture 25 2007 08 16 15 55 12 001 200 om Stable waveform 2007 08 16 15 55 10 012 Cancel Picture 25 Caution lt Please note that while the measurements from an ECG monitor are a useful guide for your doctor they cannot detect all changes in heart conditions Always consult your doctor if you notice any changes in your condition regardless of the measurement results Consult a doctor even if Stable waveform is displayed as the measurement result if you have been diagnosed with a heart condition The values displayed by the device are the values at the time of measurement Medical conditions can change suddenly If you notice any change in your condition consult your doctor regardless of the measurement results 20 V1 0B1 HANDHELD ECG MONITOR 6 Displaying ECG The GRAPH Menu is used to display lock or delete the list of ECG data stored Displaying ECG Waveform 1 If the device does NOT have stored records it will show the following information as shown in Picture 26 1 when users enter int
17. evice with the right hand make sure that the index finger makes contact with the 2 metal electrodes sufficiently Place the 9 electrodes against left chest on bare skin about 5cm bellow your left nipple Refer to Picture 20 Picture 21 Note If you have problems in applying the device so that the 9 metal electrodes are flat against your chest please ask your doctor for advice 4 4 2 Measurement for Female Locate the ECG monitor at the lower end of breastbone and move horizontally to the middle of the left part of the chest If necessary gently lift the breast and place the 9 electrodes under the left breast Unless the electrodes come in contact with the brassiere it is NOT necessary to remove it if you are unsure please consult your doctor Picture 22 To obtain the high quality ECG users can adopt the cable measurement 17 V1 0B1 HANDHELD ECG MONITOR Note The small open circle indicates the proper position of electrodes as shown in Picture 22 Improper Operation Methods A The touching point of the 9 electrodes do NOT contact left chest B The handhold gesture is NOT correct C 9 electrodes do not contact fully the skin e g the monitor impeded by clothes while taking a measurement Notes lt Make sure that you are relaxed and that your chest is free of tension lt Press the electrodes close against your bare chest Do not place the electrodes on c
18. hyde high density ozone etc Do not wash this device with water Do not store the device in the following ambient conditions Locations exposed to direct sunlight Locations subject to high temperatures and high humidity Wet or damp locations where water may get on the device Dusty locations Near fires or open flames Locations exposed to strong vibration Locations exposed to strong electromagnetic fields Dispose of the device and its accessory according to applicable local regulations V1 0B1 HANDHELD ECG MONITOR Contents 1 General Description a 6 2 Inserting and Replacing Batteries 9 3 Setting the ID Date and 11 4 Taking a 12 5 Measurement Results 20 6 Displaying ECG T T 21 TZOVSIENT SEUNG S 23 8 Data ManagemernLt a 24 9 NOTSION u aaa aaa AE 25 10 Trouble SHO OUNG uu uu uuu u u nuqam apu as 25 Ti Key SVMDOINS 3 uu Z mu ance ees 26 12 Technical Dalla L 26 13 Maintenance and
19. ing blood to fill up the heart again 32 V1 0B1 HANDHELD ECG MONITOR Right atrium 4 Fa Left ventricle Right ventricle ___ S Left atrium An ECG monitor is able to measure the electrical impulse as it passes across and through the heart causing the heart to beat An ECG does not measure the movement of your heartbeat but rather the electrical activity that causes the heart to beat The measurements recorded by an ECG monitor when combined with a medical examination can help your doctor monitor your heart condition The ECG measurements recorded by the device are NOT designed or intended for medical diagnosis Conditions such as arrhythmia and Ischemia can only be diagnosed by a doctor through a special examination About the ECG Waveform The ECG waveform shows the rhythm of your heartbeat during the 30 second measurement and displays the electrical activity causing the heart to beat The waveform for each heartbeat shows the progress of the electrical impulse across and through the heart Ventricular contraction o QRS complex Atrial contraction P wave Re polarization T wave The first peak indicates the spread of the impulse over the atria and the beginning of their contraction This is known as the P wave The second peak indicates the spread of impulse over the ventricles and the beginning of their contraction This is known as the QRS complex The third peak indicates the ac
20. licable 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 NOTE1 At 80MHz and 800MHZz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 14 Maintenance and Storage lt Clean the device with a cloth lightly dampened with water disinfectant alcohol or detergent and then wipes it dry with a dry cloth lt Wipe the electrodes using a cloth dampened with disinfectant alcohol lt Do not wipe the device with benzene gasoline paint thinner concentrated alcohol or other volatile detergents Do not place objects on top of the device This could damage the device Do not disassemble the device There are no user serviceable parts Repairs should only be carried out by authorized personnel Do not sterilize this device in an autoclave ultraviolet sterilizer or gas sterilizer formaldehyde high density ozone etc 31 V1 0B1 HANDHELD ECG MONITOR lt This device does not require calibration during the expected life cycle When display the low voltage mark 2 please change the batteries in time Dispose the used batteries according to the applicable local regulations Please remove the batteries if the device is be
21. lothing as this will result in an inaccurate measurement If measuring in dry circumstance which might cause weak heart pulse signal please wet your skin or hands with some diluted salt water or clean water This would strengthen the heart pulse signals and make the recording much more accurate When doing chest measurement if you have problems applying the device so that the 9 metal electrodes are flat against your chest please ask your doctor for advice 4 5 Cable Measurement If palm measurement is not ideal and it is not convenient to adopt chest measurement the cable measurement will be recommended The first step is to place electrodes slices on the right body area as shown in pic 23 1 and then connect the cable and the unit effectively through the lead port refer to pic 23 2 p Make sure that this surface is upward 4 Picture 23 1 Picture 23 2 18 V1 0B1 HANDHELD ECG MONITOR 1 The position for placing the cable electrode is shown in Picture 23 AHA White right arm RA electrode put it under the clavicle next to the right shoulder Black left arm LA electrode put it under the clavicle next to the left shoulder Red left leg LL electrode put it at the left of the underbelly IEC Red right arm R electrode put it under the clavicle next to the right shoulder Yellow left arm L electrode put it under the clavicle nex
22. m and analysis result Measurement of one channel ECG anytime anywhere you like Display of ECG waveform heart rate analysis results and battery status on the backlit LCD screen Auto power off while no key is pressed in period of time that can be set Auto evaluation based on detected heart data Two AAA batteries can support at least 400 measurements Data Review freely 1 3 Intended Use The MD100 ECG monitor is a handheld device indicated for use in non invasively detect and displaying ECG waveform for self testing of adult in daily life otherwise it also can provide the doctor with relevant data on the heart condition of the patient in hospital It is available to manually record transient cardiac events immediately at any time suitable for patient and professional use helpful in determining cardiac aetiology of symptomatic events This ECG monitor allows the consumer to record their ECG data into the device memory and displays the ECG data to the healthcare professional during office visits NOTE 1 The measured result by the product is just for reference to doctor but not for diagnosis evidence 2 The product is not suitable to monitor patient continuously 1 4 Display The screen is used to display the ECG waveform analysis results all kinds of parameters such as time amp date battery status etc and the status of data storage in memory V1 0B1 HANDHELD ECG MONITOR Menus y lt Version
23. o not use on people with sensitive skin or allergies This may result in exanthema skin irritation or eczema Keep out of reach of small children and people who cannot express their consent Do not use for any purpose other than obtaining an electrocardiograph lt Do not expose the device to strong shocks or vibrations or drop or step on the device Do not use batteries of a type other than that specified in this manual Do not apply over clothing V1 0B1 HANDHELD ECG MONITOR Do not take measurements when there are drops of water on your skin such as from sweat or after bathing lt Do not take measurements where the device will be exposed to strong electromagnetic forces Caution Do not expose the device to static electricity Always disperse any static electricity from your body before handling the device Do not take measurements in a moving vehicle Do not use a cellular phone near the device Do not disassemble repair or modify the device Do not insert batteries with their polarities reversed lt The chest electrode will be impeded by excessive body hair regularly remove hair at the electrode contact point General Avoid extremes in temperature and humidity Do not use this device in locations subject to high or low temperatures or humidity Use at a temperature within 5 C to 40 C and below 80 RH Do not sterilize this device an autoclave or gas sterilizer EOG formalde
24. o the Wave Review menu AN NO record Picture 26 1 2 Press the W J gt button to select the GRAPH Menu when the main menu appears and then press OK button to confirm Refer to Picture26 2 2007 08 16 15 55 12 007 200 m p 2007 07 26 09 30 m 2 078 2 2007 07 26 03 39 3 2007 07 25 23 38 4 2007 07 25 23 22 Picture 26 2 3 Press the W gt or lt button to select the ECG data you wish wo view from the ECG data list then press the OK button to display the detailed view of the waveform Refer to Picture 26 3 Press the WE lt V A button to move forward backward the waveforms Press MENU button to exit from the current menu 2007 08 16 15 55 12 001 200 Picture 26 3 21 V1 0B1 HANDHELD ECG MONITOR Description of picture 26 3 001 200 It indicates one measurement has been saved in the monitor and the monitor can store up to 200 records ECG amplitude ruler dnl ECG waveform Measurement progress bar 2 The interval of the current ECG waveform Every piece of stored ECG data is displayed with date time and a character representing the measured waveform Measuring result depiction After review the certain ECG waveform press the OK button to enter in to the corresponding analysis result depiction refers to Pic 27 2007 08 16 15 55 12 001 200 DELETE S H
25. ostatic Floors should be wood concrete Discharge contact contact or ceramic tile If floor are ESD 8kV air 8kV air converted with Synthetic material IEC610004 the relative humidity should be at 2 least 30 Guidance and manufacture s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING 29 V1 0B1 HANDHELD ECG MONITOR 4 d 80MHz to 800MHz 61000 4 6 35 JP Radiated RF IEC 61000 4 3 Where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacture and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as A determined by an electromagnetic site survey should be less than the compliance level in each frequency range Inter ference may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80MHz and 800MHzZ the higher frequency range applies NOTE2 These guideline may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A Field strengths from fixed transmitters such as base situation 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
26. rm and meanwhile return to the previous menu 7 3 Beep Setting 7 3 1 Press the WI gt button or lt J A to select the Beep menu Then press the button to enter Select On or Off by pressing the lt A button or WE and press OK button to confirm setting Refer to picture 30 Picture 30 7 3 2 Press the OK button to save the settings meanwhile return the previous screen 23 V1 0B1 HANDHELD ECG MONITOR 7 4 Auto Power off Setting 7 4 1 Press the WE button to select the Auto Poweroff then press the OK button to enter Press the button WE I A button to select off time limit 1 Min 2 Min 10 Min refer to Picture 31 S and press OK button to confirm the setting Picture 31 7 4 2 Press the OK button to confirm and meanwhile return to the previous menu 7 5 Wave Scale Setting 7 5 1 Press the WE button to select the Wave Scale then press the OK button to enter Press the WE button or lt VA button to select 0 5 x1 x1 5 x2 refer to Picture 33 2007 07 26 10 32 09 011 200 a a Se NE E 82 10 Setup gt Wave Scale Wave Scale s l j LZ Picture 32 Picture 33 7 5 2 Press the OK button to confirm and meanwhile return to the previous menu 8 Data Management In the main menu screen press the W gt button to select the Data Management item and then
27. s reserved Issue date 9 September 2009 V1 0B1 HANDHELD ECG MONITOR Notes on Safety This device is intended to monitor the ECG waveform not for medical diagnosis Never use the device in critical situations Self diagnosis and treatment is dangerous The measurement results are reference for analyzing the cardiac rhythm of patients by doctors only and should never be used as a basis for starting or modifying treatment without independent confirmation by medical examination Do NOT make diagnosis by yourself according to the measurement and analysis results always consult your doctor if abnormal information is presented frequently The values displayed by the device are the values at the time of measurement Medical conditions can change suddenly If you notice any change in your condition consult your doctor regardless of the measurement results DO NOT Use the device for treatment we will not responsible for the suddenness happened during a measurement Warnings Do not use with a cardiac pacemaker Do not use with a defibrillator Do not use in the presence of flammable anesthetics drugs or pressurized oxygen such as in a hyperbaric chamber ultraviolet sterilizer or oxygen tent lt Do not attempt self diagnosis of the measurement results and analysis Always consult your doctor Self diagnosis may lead to deterioration in your condition Do not use on patients with significant resting tremors lt D
28. st for approximate 400 measurements I measurements are performed once a day at room temperature 22 C The batteries enclosed in the package are used for demonstration purpose It is possible that these batteries will not last for 400 measurements The battery life can be confirmed in the upper right of the LCD display ee Full power low power power Battery power is low please change with new ones When the sign _ 2 appears it means the timely battery power is not sufficient and the device will show information as picture 5 We suggest users replace the batteries with new Picture 5 Low power ones AN Warnings If battery fluid should get in your eyes immediately rinse with plenty of clean water Consult a doctor immediately Caution Do not use batteries not specified for this device Do not insert the batteries with the polarities in the wrong direction Do not dispose of batteries in fire 10 V1 0B1 HANDHELD ECG MONITOR If battery fluid should get on your skin or clothing immediately rinse with plenty of clean water Remove batteries from this device when you are not going to use it for a long period of time approximately three months or more Do not use batteries of a different type together Do not use new and used batteries together 3 Setting the ID Date and Time Always set the ID number date and time before using the device for the first time
29. t to the left shoulder Green left leg F electrode put it at the left of the underbelly Note Be sure to place the electrode slices over measured part well before pressing the START button 2 The connection with ECG lead cable refer to picture 23 2 Make sure that deeply insert the ECG cable connector with mild force When the measurement is failed please check the placement of electrode slices or the connection of the unit and lead cable Wrong Operation Methods A Connect wrong cable mount B Electrodes contact wrong position of the body A Warnings Very Important Users are strictly prohibited to attach the lead wire electrodes on their body if the lead wire is not connected with the device Before measurement firstly the lead wire should be connected with the device secondly the lead wire electrodes should be attached to your body After measurement firstly the lead wire electrodes should be removed from body secondly the lead wire should be disconnected with the device 4 6 Continuous Mode In the Measurement Mode you can select the Continuous Mode for long term monitoring The measurement can be last for about 6 hours with two new batteries 2007 08 16 15 55 12 001 200 K Measurement Mode Easy Mode Picture 24 19 V1 0B1 HANDHELD ECG MONITOR Note In the continuous Mode the measurement results can not be saved in the monitor But the measurement r
30. tivity as the heart relaxes re polarization 33 V1 0B1 HANDHELD ECG MONITOR and is known as the T wave What is Arrhythmia Arrhythmia is a condition where the heartbeat rhythm is abnormal due to flaws in the bio electrical system that drives the heartbeat Typical symptoms skipped heartbeats premature contraction an abnormally rapid tachycardia or slow bradycardia pulse This can be caused by heart disease ageing physical predisposition stress lack of sleep fatigue etc Arrhythmia can only be diagnosed by a doctor through a special examination What is Ischemia Ischemia is a condition in which insufficient oxygen is supplied to parts of the heart or other parts of the body This is usually due to a blockage or partial blockage of an artery Ischemia can only be diagnosed by a doctor through a special examination 34 V1 0B1 HANDHELD ECG MONITOR ad Beijing Choice Electronic Technology Co Ltd BailangyuanB1127 1128 Fuxing R A36 100039 Beijing PEOPLE S REPUBLIC OF CHINA EiffestraBe 80 20537 EC REP Hamburg GERMANY Shanghai International Holding Corp GmbH Europe 012 w 35
31. used for a long period of time The environment temperature for transport or storage of the packaged device is 4 131 F 20 C 55 C and the humidity is lt 93 no condensation A Caution Keep operating environment clean quiet no erodent and no flammable material Do not use this device in the environment with too high or too low temperature and humidity lt If this device is splashed or contaminated by water drop please stop operating Please do not use the device at once when it is moved from cold place to the warm and moist place lt Please do not use sharp tools to operate any of buttons Do not immerge the device into liquids or clean the surface with organic liquid and do not splash liquids on the device 15 General information about the Heart and ECG Measurements The heart is a muscular pump controlled by electrical impulses generated by the body It is divided into two by the septa and each side has two chambers an atrium and a ventricle linked by a one way valve The left atrium and ventricle control oxygenated blood and the right atrium and ventricle control de oxygenated used blood The electrical impulse that causes the heart to beat spreads across the atria causing the left and right atrium to contract and pump blood into the left and right ventricles respectively The two ventricles then contract and pump blood out of the heart The heart muscle then relaxes or re polarises allow
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