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VER1.0B1                                                          HeartCheck  HANDHELD  ECG  MONITOR

 

 

- 2 -

Notes on Safety

 

This device monitors and records ECG waveforms, it is not intended for medical 
diagnosis. Please refer any recordings to a qualified physician for medical interpretation. 
This device is not a substitute for seeking medical attention. If you believe you are 
experiencing any adverse medical event, you are to seek medical attention immediately. 

The recordings should be used as a reference for analyzing cardiac rhythm by doctors 
only. Always consult your doctor. 

Medical conditions can change suddenly. If you notice any change in your condition, 
consult your doctor, regardless of the measurement results. 

Warnings! 

—

  Not intended for use on individuals with a cardiac pacemaker. 

—

  Not intended for use with an implanted 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). 

—

  Do not use on individuals with significant resting tremors. 

—

  Do not use on individuals with dermatological conditions. 

—

  Intended for adult user only. 

—

  Do not use batteries of a type other than that specified in this manual. 

—

 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. 

—

 The chest electrode will be impeded by excessive body hair, remove hair at the 

electrode contact point. 

Содержание MD100B

Страница 1: ......

Страница 2: ...tal 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...

Страница 3: ...ended for use with an implanted 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 Do not use on individuals with significant resting tremors Do not use on individuals with dermatological conditions Intended for adult user only Do not use batteries of a type other than that specified in...

Страница 4: ...EOG formaldehyde 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 electro...

Страница 5: ...g Date and Time 8 4 Taking a Measurement 9 5 Displaying an ECG 19 6 System Settings 21 7 Data Management 22 8 Version 23 9 Data Transmission 23 10 Trouble Shooting 23 11 Key Symbols 24 12 Technical Data 25 13 Maintenance and Storage 26 14 General information about the Heart and ECG Measurements 27 Appendix 29 ...

Страница 6: ...or set date and time when in the Date and Time Setting Mode Button Press this button to move the cursor to your desired menu or change the number or move the wave form to the left Button Press this button to move the cursor to your desired menu or change the number or move the wave form to the right MENU button Return to the previous menu by pressing this button Left Metal Electrodes Place this ag...

Страница 7: ...ovided to review recordings 1 3 Intended Use The MD100 ECG monitor is a handheld device intended for use in non invasively recording and displaying of ECG waveforms for self recording of adults in daily life under physician direction to provide the physician with relevant data on the heart condition of their patient The MD100 is a patient triggered event recorder which makes available to patients ...

Страница 8: ...HELD ECG MONITOR 7 1 4 Display The device screen is used to display the ECG waveform a confirmation of the ECG quality other parameters such as time date battery status and the status of data storage in memory Menu interfaces ...

Страница 9: ...e s information 2 Battery Installation 2 1 Open the battery cover on the back panel of the device 2 2 Insert two AAA batteries as indicated by the polarity sign refer to Picture 2 1 Picture 2 1 2 3 Replace the battery cover on the back panel of the device Ensure the polarity of the batteries is correct otherwise the device will not function correctly Battery life and replacement When the Battery p...

Страница 10: ...Disposal of the batteries should comply with local laws and regulations 3 Setting Date and Time Always set the date and time before using the device for the first time Routinely check whether the date and time are correct before using the device and reset if necessary The date and time are important indicators when a measurement is taken 3 1 Date and time setting Note The date and time information...

Страница 11: ...aking 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 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 slig...

Страница 12: ... the electrodes by wiping them with a soft cloth or cotton swab moistened with disinfectant alcohol 4 2 Measurement Methods There are three ways to record an ECG using this device palm measurement chest measurement and cable measurement The ideal posture for any of the methods listed above is to be seated comfortably with your back straight You can also take a measurement while you are standing or...

Страница 13: ...please try one of the alternative methods outlined below or consult your physician Wrong Operation Methods A Hand contact with the electrodes become loose during the measurement B Palm or fingers are not covering the electrodes 4 2 2 Chest measurement If palm measurement is not ideal please adopt chest measurement 1 Measurement for Male Hold the device with the right hand make sure that the index ...

Страница 14: ...you are unsure please consult your doctor Note The proper position of the left metal electrodes is shown in Picture 4 3 Improper Operation Methods A The left metal electrodes are not in contact with the left chest B The hand positioning is not correct on the right metal electrodes Notes Make sure that you are relaxed Press the electrodes against your bare skin Do not try and take a recording throu...

Страница 15: ...osition for placing the cable electrodes is shown in Picture 4 4 White right arm RA electrode under the clavicle next to the right shoulder Black left arm LA electrode under the clavicle next to the left shoulder Red left leg LL electrode at the left of the underbelly Note Ensure the electrode patches are placed in the correct positions and are well attached before pressing the START button 2 Conn...

Страница 16: ...he interface switches to the one as shown in Picture 4 7 Measurement Modes include Easy Mode and Continuous Mode Choose the Easy Mode item and click the OK button The interface will appear as shown in Picture 4 8 After the count down from six to zero the measurement will start Picture 4 6 Picture 4 7 Picture 4 8 Additionally you can press the START button to quickly start a measurement based on th...

Страница 17: ...er level of the battery ECG amplitude ruler The examined ECG waveform 1 ECG waveform scale You can select the displaying scale x 0 5 x 1 x 1 5 or x 2 in the SET Menu Speaker status On or Off The status bar showing measurement progress 2 Indication of measurement time The sign of heartbeat it flashes on and off synchronously with the heart beat A measurement result message is displayed when the mea...

Страница 18: ... OK button to return the Menu interface To save the ECG result please perform the following steps To save the ECG press the OK button when the Save item is highlighted or it will be saved automatically within 3 seconds The screen then switches to the user information interface Refer to Picture 4 12 The user information is shown to allow the user to confirm the patient s identity Picture 4 12 Pictu...

Страница 19: ...Name selection see instructions above Note Each field is large enough to accommodate 15 characters or numbers Picture 4 15 To save the information press the MENU button to move the cursor to the Save location and then press the OK button to save patient information and exit the current interface The device can save 200 30 second ECG records When the device memory is full the icon will appear on th...

Страница 20: ...ble waveform is displayed as the measurement result 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 prior measurement results 4 3 2 Continuous Mode The device must be connected to a computer prior to the start of a recording In the Measurement Mode yo...

Страница 21: ...ppears and then press the OK button to confirm If the device does NOT have stored records it will show the following information as shown in Picture 5 1 when users enter into the Graph Menu screen Picture 5 1 2 Press the button to select the Graph Menu when the main menu appears and then press the OK button to confirm Refer to Picture 5 2 Picture 5 2 3 Press the or button to select the ECG data yo...

Страница 22: ...t depiction After reviewing a certain ECG waveform press the OK button to enter in to the corresponding ECG quality result depiction Refer to Picture 5 4 Picture 5 4 In the current menu press the or button to select YES NO or the icon and then press the OK button to delete save or lock the result Deleting or locking the ECG data record Deleting Under the interface such as in Picture 5 4 press the ...

Страница 23: ...se refer to section 3 Setting Date and Time 6 2 Brightness Setting 6 2 1 Press the button to select the Brightness item and then press the OK button to enter Press the button or to select the backlight level from Off to 1 2 3 7 Refer to Picture 6 1 Picture 6 1 6 2 2 Press the OK button to confirm and return to the previous menu 6 3 Beep Setting 6 3 1 Press the button or to select the Beep item The...

Страница 24: ...ture 6 3 Picture 6 3 6 4 2 Press the OK button to confirm and to return to the previous menu 6 5 Wave Scale Setting 6 5 1 Press the button to select the Wave Scale item and then press the OK button to enter Press the button or button to select x0 5 x1 x1 5 or x2 refer to Picture 6 5 Picture 6 4 Picture 6 5 6 5 2 Press the OK button to confirm and to return to the previous menu 7 Data Management In...

Страница 25: ...information about the device will be displayed 9 Data Transmission Before data transmission make sure that the device is on and connected to a computer by the data cable For data transmission operations refer to the accompanying Software User Manual 10 Trouble Shooting Problem Cause Solution The device can NOT be turned on 1 The batteries are drained or almost drained 2 The batteries are not inser...

Страница 26: ...r oily 2 Electrode and body does not contact tightly 3 Your body is too tense 1 Clean the skin thoroughly with soap and water prior to use 2 Press the electrode with a certain force 3 Relax and repeat the measurement 11 Key Symbols Symbol Meaning Symbol Meaning Type CF applied part Record is locked Caution May indicate important information Record is full Heart rate Unit BPM beat per minute Power ...

Страница 27: ...el amount 1 difference input Measuring electrodes Four integrated metal electrodes Three Measuring parts The signals measured can be lead I between right and left hand and approximate lead II or lead III between both hands and the chest Note The signals measured by the device positioned from the right hand and left hand is lead I on a standard surface ECG The signals measured by the device positio...

Страница 28: ...ece Electrodes 1 Packet Certificate of Quality 1 piece 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 provided with the equipment use of other accessories will render the warranty null and void 13 Maintenance and Sto...

Страница 29: ...Please do not use the device when it is moved from a cold place to a warm and moist place The device should be given some time to adjust to the change in temperature Please do not use sharp tools to operate any of the buttons Do not immerge the device into liquids or clean the surface with organic liquid and do not splash liquids on the device 14 General information about the Heart and ECG Measure...

Страница 30: ...sed 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 The first peak indicates the spread of the impulse over the atria and the beg...

Страница 31: ...only be diagnosed by a doctor 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 the electromagnetic environment special below The customer or the user of Handheld ECG monitor should assure that it is used in such an environment Immunit...

Страница 32: ...loser to any part of the Handheld ECG monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d P V1 5 3 80MHz to 800MHz d P E1 7 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in Watts W according separation distance in meters m Field strengths from...

Страница 33: ...d strengths should be less than 3V m 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 environm...

Страница 34: ...1 At 80MHz and 800MHz 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 Distributor MD Primer Inc 2 St Clair Avenue East Fifth Floor Toronto Ontario M4T 2V5 Tel 647 288 3892 Fax 416 977 8607 www mdprimer com Manufacturer Beijing...

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