Omron HCG-801 User's Manual
Contents
1. A A O Power Cancel button G OK button Turns the power on off and cancels measurement Selects the highlighted menu option or ECG B Chest electrode data A Clears error messages Place this against your chest when taking a measurement H Battery cover C Display Open this cover to insert batteries Displays the wave pattern after measurement and l Finger electrodes displays menus and setting options Place your right index finger over these when D MENU button taking a measurement Displays or closes the menu screen J START button E lt amp button Starts measurement Moves the desired menu or wave pattern to the left or K SD memory card slot cover up and decreases the number of the selected field Open this cover to insert the SD memory card F W button Moves the desired menu or wave pattern to the right or down and increases the number of the selected field HCG 801 E book Page 7 Tuesday December 13 2011 5 35 PM l ai 1 Know Your Unit Replacements Parts Zs L SD memory card M Storage pouch SIB SO HCG 801 E book Page 8 Tuesday December 13 2011 5 35 PM ki 1 Know Your Unit W Display The screen is used to display the guidance screens and results of ECG readings adjust settings and manage ECG data stored on the SD memory card or in unit memory Menus Date and Time Volume Brightness ESIGRAPH menu SET menu 17 1 05 0 02. Copying SD memory DO NOT REMOVE SD ECG data is being copied to the SD memory card Wait until the message disappears Do not remove the SD memory card until data copying has been completed Data in device memory is being erased ECG data stored on the unit is being erased Wait until the message disappears Data in SD is being erased DO NOT REMOVE SD until erasing finishes ECG data stored on the SD memory card is being erased Wait until the message disappears Do not remove the SD memory card until data erasing has been completed Reading data DO NOT REMOVE SD The unit is loading ECG data stored on the SD memory card Wait until the message disappears Do not remove the SD memory card until the data has been loaded by the unit No SD is inserted There is no SD memory card in the card slot Turn off the power and insert the SD memory card Never insert the SD memory card while the power is turned on 47 e SIB L HCG 801 E book Page 48 Tuesday December 13 2011 5 35 PM 10 Care and Maintenance Message The unit is unable to access data SD is write protected because the SD memory card inserted is write protected Refer to the instruction supplied with the memory card and insert the SD memory card with write protection turned off The battery power has run low No saved data and the ECG data stored on the unit has disappeared
3. Do not disassemble the unit There are no user serviceable parts Repairs should only be carried out by authorized personnel TEN Do not sterilise this unit in an autoclave ultraviolet steriliser or gas steriliser EOG formaldehyde high density ozone etc e This device does not require calibration during the expected life cycle of five years a p 4 HCG 801 E book Page 52 Tuesday December 13 2011 5 35 PM 12 Technical Data Model Induction system Heart rate range Accuracy Enclosure ingress protection Display Memory Type of protection against electric shock Classification of Applied Parts Power Supply Battery life Operating Temperature and Humidity Storage Temperature and Humidity Weight Dimensions Attachments Other Symbol Mark HCG 801 Bipolar single channel 2 to 200 beats min Bandwidth 0 05 to 40Hz Sampling Rate 125Hz IP20 Graphic LCD 5 measurements using the unit s internal memory 300 measurements using the supplied SD memory card INTERNALLY POWERED TYPE BF 2 LRO3 AAA batteries Approximately 400 measurements with alkaline batteries When measurements are taken once a day at room temperature 22 C 10 to 40 C 30 to 85 RH 20 to 60 C 10 to 95 RH Approximately 130g including batteries 121 mm W x 67 mm H x 24 mm D Batteries 2 x LRO3 AAA SD memory card Storage pouch Instruction manual Quick reference card Registration car
4. NZ SO HCG 801 E book Page 10 Tuesday December 13 2011 5 35 PM ki 1 10 T 2 Inserting and Replacing Batteries Slide the battery cover in the direction of the arrow and lift the end of the cover upwards Note Do not pull too hard on the cover Insert two LRO3 AAA batteries as indicated Always use LRO3 AAA batteries Note Make sure that the polarity of the batteries is correct Close the battery cover Lower the battery cover 1 then while gently pressing the cover down slide it in the direction of the arrow 2 Zi o S HCG 801 E book Page 11 Tuesday December 13 2011 5 35 PM Battery life and replacement 2 Inserting and Replacing Batteries When the Please insert new batteries message appears replace both batteries with new ones e Always turn the unit off before replacing the batteries e Dispose of the used batteries according to applicable local regulations Battery life e Two new LRO3 AAA batteries will last for approximately 400 measurements If measurements are taken once a day at room temperature 22 C e The batteries enclosed in the package are used for demonstration purpose It is possible these batteries will therefore not last for 400 measurements If the batteries are removed for more than one hour the settings and any ECG data stored in the unit may be erased If the date and time setting is erased be s
5. Write Protection Locking the SD Memory Card Make sure that the write protect switch is not locked before inserting the SD memory card If the write protect switch is locked down you will not be able to store new ECG data on the SD memory card Caution When inserting the SD memory card do not try to force the card into the slot if it is upside down back to front etc This could damage the card or the unit itself p SIB Zs HCG 801 E book Page 17 Tuesday December 13 2011 5 35 PM 4 Using SD Memory Card 3 Close the SD memory card slot cover OMRON tHc6 s01 Sp e e mi a HCG 801 E book Page 18 Tuesday December 13 2011 5 35 PM l ki 4 Using SD Memory Card To eject the SD memory card 1 Check that the device is turned off Zs Caution Only eject an SD memory card when the unit is turned off 2 Open the SD memory card slot cover and press the memory card The lock is released and the card is ejected slightly De OMRON tc6 s01 3 Remove the memory card ai eee DO n OMRON xc6 s01 4 Close the SD memory card slot cover SV Z A 7 A HCG 801 E book Page 19 Tuesday December 13 2011 5 35 PM L ki 4 Using SD Memory Card W 4 2 Formatting an SD Memory Card You will need to format the SD memory card before you use it for the first time and in the following circumstances e If you use an SD memo
6. 4 2 Formatting an SD Memory Card on p 19 if you wish to delete the data li e 2 N A HCG 801 E book Page 45 Tuesday December 13 2011 5 35 PM A ai 9 Managing ECG Data W Copying data from a PC to the SD memory card Please follow these instructions to copy data from a PC to the SD memory card 1 Make sure the PC is equipped with an SD memory card port or connect a commercially available SD memory card reader writer to your PC 2 Insert the SD memory card in the SD port of your PC and confirm that there is an hcg801 folder in the SD memory card If there is not format the SD memory card in the HCG 801 as described in section 4 2 of the HCG 801 instruction manual 3 Browse to the folder where you saved the ECG data in the PC Select all files and copy them to the SD memory card in the ncg801 data folder where stands for the character of a removable disk 4 When copying is finished insert the SD memory card in the HCG 801 as described in 4 1 Inserting and Ejecting SD Memory Card on p 15 5 Do not store more than 300 measurement files in this folder on the SD memory card When more than 300 files are copied in this folder the HCG 801 will display an error message when activated 45 eo 2 N SIB as HCG 801 E book Page 46 Tuesday December 13 2011 5 35 PM 10 Care and Maintenance 10 1 Lists and Explanations of Messages This section includes a
7. Insert new batteries and reset the Date and Time and other settings Any ECG data that was stored on the unit cannot be recovered The battery power has run low Set clock and the Date and Time setting on the unit has disappeared Insert new batteries and reset the Date and Time from the SET menu The battery power has run low No saved data and the ECG data stored on the Set clock unit has disappeared or the clock has been reset Error Messages Error Message Please insert new The batteries are worn out batteries Insert new batteries and reset the Date and Time and other settings Replace both batteries with new ones An error occurred while trying to read ECG data stored in unit memory Device memory error Cannot read data An error occurred while trying to erase ECG data stored in unit memory Device memory error Cannot erase data An error occurred while trying to save ECG data to unit memory Device memory error Cannot write data 48 a p Try again If the error still occurs consult your OMRON service representative e 2 N a 10 Care and Maintenance SIP SO HCG 801 E book Page 49 Tuesday December 13 2011 5 35 PM Message SD memory error Cannot read data An error occurred while trying to read ECG data stored on the SD memory card SD memory error Cannot erase data An error occurred while trying to erase
8. 2 Press the OK button E mErase all dat H 9 pi The message Erase all data in SD memory is Erase all data displayed in D memory TEN Note If the SD memory card is not inserted and measurements are being stored in unit memory the message Erase all data in the device is displayed By default NO is highlighted 39 WZ O a HCG 801 E book Page 40 Tuesday December 13 2011 5 35 PM Bi 9 Managing ECG Data 3 Press the W button and select YES then press the OK E sa d button fikrase all data Erase 5 data The number of sets of data to be deleted is displayed 4 Press the W button and select YES then press the OK button All the ECG data is erased and the screen from step 1 appears Note If you press the OK button after selecting NO the screen from step 1 appears Erasing Selected ECG Data Use the GRAPH menu if you only want to delete a selected set of ECG data For details on displaying the GRAPH menu follow step 1 in 7 Displaying ECG Data on p 28 1 Press the W D button to highlight the data you want to erase 2 Press the MENU button The menu screen is displayed 3 Press the W button and select Erase data e 2 N SIB SO HCG 801 E book Page 41 Tuesday December 13 2011 5 35 PM 4 Press the OK button The confirmation message Erase selected data is displayed 5 Pr
9. You can use the SET menu to adjust various settings You can press the START button to begin measurement even while the SET menu is displayed 8 1 Basic Operation The following procedure describes how to select and adjust a setting Refer to the following pages for details of the options available for each setting 1 Press the MENU button while the unit is on to display the menu screen ESGRAPH men ES Initially GRAPH menu is highlighted 2 Press the W C gt button to select SET menu 3 Press the OK button Initially the Date and Time setting is highlighted 30 ki a SO HCG 801 E book Page 31 Tuesday December 13 2011 5 35 PM 8 Adjusting the Settings Press the D A or W L button to select the desired setting then press the OK button to see the options for that setting Date and Time 4 Yol ume Brightness GLontrast Language 31 12 05 13 30 lt aOverwrite TErase all data Data copy to SD 31 12 05 13 30 5 Adjust the settings then press the OK button to confirm the changes The SET menu can be used to adjust the following settings or manage ECG data stored on the SD memory card or unit Date and Time Volume Brightness Contrast Language Date Format Message Overwrite Erase all data Data copy to SD Formatting SD Notes Refer to 9 Managing ECG Data on p 39 for details on Erase all data and Data copy to SD Refer
10. You can select one of four formats DD MM YY HH MM 24 hour clock DD MM YY HH MM AM PM MM DD YY HH MM AM PM or YY MM DD HH MM AM PM E gt 12 31 05 1 30PH 05 12 31 1 30PM E Date format SHessage 5a0verurite TErase all data Data copy to SD 31 12 05 13 30 The date is displayed at the bottom ofthe screen using the currently selected format DD MMIYY HKEMM 24 hour clock Press the J A button or Y O button to select the desired format then press the OK button to confirm your selection e a AM SO A HCG 801 E book Page 37 Tuesday December 13 2011 5 35 PM ki 8 Adjusting the Settings 8 8 Messages This setting specifies whether to display or hide the message that appears after a measurement has been completed E Date format 30verwrite gt TErase all data Data copy to SD Display The current setting is displayed at the A YA e api naa bottom of the screen The default setting is Display 1 Press the Q A button or W button to highlight the Display or Hide then press the OK button to confirm your selection Note Even if Hide is selected results messages are saved by the unit 37 a p 9 T AM as A HCG 801 E book Page 38 Tuesday December 13 2011 5 35 PM ai 8 Adjusting the Settings 8 9 Overwrite The unit will overwrite the oldest stored reading when the SD memory card or unit memory is full A message will warn that
11. any static electricity from your body before handling the unit Do not take measurements in a moving vehicle Do not use a cellular phone near the unit Do not disassemble repair or modify the unit Do not insert batteries with their polarities reversed e The chest electrode will be impeded by excessive body hair regularly remove hair at the electrode contact point Omron does not recommend the use of contact gel General e Avoid extremes in temperature and humidity Do not use this unit in locations subject to high or low temperatures or humidity Use at a temperature within 10 to 40 C and between 30 and 85 RH Do not sterilise this unit in an autoclave or gas steriliser EOG formaldehyde high density ozone etc EN Do not wash this unit with water Do not store the unit 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 unit Dusty locations Near fires or open flames Locations exposed to strong vibration Locations exposed to strong electromagnetic fields a 5 p HCG 801 E book Page 6 Tuesday December 13 2011 5 35 PM Zs 1 Know Your Unit Main Unit e A
12. default setting is the maximum brightness level Press the D A button or W button to adjust the brightness The brightness can be set to one of nine levels The brightness increases as the amp marker moves to the right 33 a p a AM as A HCG 801 E book Page 34 Tuesday December 13 2011 5 35 PM Ei 8 Adjusting the Settings 8 5 Contrast E E W Date and Time Volume Brightness E gt The current contrast level is displayed The mark indicates the at the bottom of the screen contrast level The default setting is medium contrast level Press the D A button or W button to adjust the contrast The contrast can be set to one of nine levels The contrast increases as the 4 marker moves to the right 34 a p 9 a A HCG 801 E book Page 35 Tuesday December 13 2011 5 35 PM 8 Adjusting the Settings W 8 6 Language This setting specifies the language to be used for the screen display EZ ET E W Date and Time Volume Brightness E gt Contrast Language The currently selected language is The default language is English displayed at the bottom of the screen Press the Q A button or W button to select the desired language then press the OK button to confirm your selection 35 a p 9 T Z ie A HCG 801 E book Page 36 Tuesday December 13 2011 5 35 PM L ki 8 Adjusting the Settings W 8 7 Date Format
13. held in the left hand Always use your right hand to hold the unit when taking a measurement The rear of the unit is placed The chest electrode is against the against the chest finger and the finger electrode is against the chest SIP SO HCG 801 E book Page 27 Tuesday December 13 2011 5 35 PM 6 Taking a Measurement Measurement Resuit There are 13 messages regarding the measurement result A letter of the alphabet indicates each of the 13 possible messages This letter is displayed together with the time and date of the measurement when the GRAPH menu is displayed Important Do not interpret measurement results yourself consult your doctor Stable waveform Fast heart rate Fast and irregular heart rate Fast heart rate and deviating waveform Fast and irregular heart rate deviating waveform Slow heart rate Slow and irregular heart rate Slow heart rate and deviating waveform Slow and irregular heart rate deviating waveform Irregular heart rate Irregular heart rate and deviating waveform Deviating waveform Analysis impossible Please measure again 3 x s aQ a o a ao o Recommendation on measurement result In addition to the above messages the device will display the heart rate in beats per minute Finally the device will display one of the following messages TEN Store data Yes No This message will be displayed whe
14. list of all messages that may appear on the display Refer to these if you are not sure what a displayed message means Notice Messages No action required Wait until analysis ends Analysing The ECG data is being analysed C t AA an A ECG wave pattern could not Check the instructions and da follow the instructions be detected repeat measurement Measurement was stopped Push START to begin measurement again The measurement was Press START to resume the interrupted or cancelled measurement The indicated number of ECG data has been copied to an SD No action required memory card Wait until the message The indicated number of ECG disappears data has been erased 1 Number of readings from 0 to 5 The number displayed represents the amount of copied ECG data 2 Number of readings from 1 to 300 The number displayed represents the amount of erased ECG data 46 a p Warning Messages A HCG 801 E book Page 47 Tuesday December 13 2011 5 35 PM a 10 Care and Maintenance Formatting SD memory DO NOT REMOVE SD The SD memory card is being formatted Wait until the message disappears Do not remove the SD memory card until formatting has been completed Storing on SD memory DO NOT REMOVE SD ECG data is being written saved to the SD memory card Wait until the message disappears Do not remove the SD memory card until data storage has been completed
15. the electrodes are applied correctly However for some individuals measurement may not be possible ECG data has disappeared The batteries are worn out or have been removed for over one hour The unit will not be able to store data if left with worn batteries for an extended period Replace the batteries with new ones as soon as possible after the warning message appears ECG data has disappeared from an SD memory card The card was exposed to a strong electromagnetic field electric noise or static damaging the data stored on the card Or the card is defective Erased data cannot be recovered Format the SD memory card again Other problems Turn off the unit and try again If the data and time or other settings have been reset to their default values set them again If the problem still occurs consult your Omron Customer Service Department Tel 0870 7502771 50 WZ pa HCG 801 E book Page 51 Tuesday December 13 2011 5 35 PM 11 Maintenance and Storage e Clean the unit with a cloth lightly dampened with water disinfectant alcohol or detergent then wipe it dry with a dry cloth Do not wipe the SD memory card slot cover e Wipe the electrodes using a cloth dampened with disinfectant alcohol e Do not wipe the unit with benzene gasoline paint thinner concentrated alcohol or other volatile detergents e Do not place objects on top of the unit This could damage the unit
16. to 4 Using SD Memory Card on p 15 for details on Formatting SD To return to the menu screen from the SET menu screens press the MENU button To return to the previous screen highlight Back then press the OK button or MENU button EN e If you press the MENU button without first pressing the OK button after making the changes to a setting the changes to the setting will not be implemented 31 cD e AM AS A HCG 801 E book Page 32 Tuesday December 13 2011 5 35 PM lt l Ei 8 Adjusting the Settings 8 2 Date and Time Select this item if you need to reset the date and time for some reason For details on setting the date and time refer to p 13 Note You will be prompted to set the date and time when you first insert the batteries Si Volume ay The current volume level is displayed The A mark indicates the at the bottom of the screen volume level The default setting is the maximum volume level Press the D A button or A C button to adjust the volume The volume increases as the mark moves to the right The sound is muted off when the mark is to the far left 32 a 9 a SIB SO HCG 801 E book Page 33 Tuesday December 13 2011 5 35 PM Bi 8 Adjusting the Settings W 8 4 Brightness B E E W Date and Time Volume The current brightness level is displayed The w mark indicates the at the bottom of the screen brightness level The
17. 0 Menu screen Settings SET menu screen The main menu screen is The setting menu screen is displayed displayed when you press the when you select the SET menu and MENU button press the OK button N GRAPH menu Q Back This allows you to view ECG readings stored This option takes you back to the previous on the SD memory card or in unit memory screen from the SET menu p 28 R Close O SET menu This option closes the menu screen This allows you to set the date and time and adjust other settings p 30 P GUIDE This displays the guidance screens that show you how to take a measurement 2 N WZ ie HCG 801 E book Page 9 Tuesday December 13 2011 5 35 PM ki 1 Know Your Unit W ECG Graph This screen is displayed when you use the GRAPH menu to select ECG data stored on the unit S Calibration guide V SD memory card indicator Serves as a guide when your doctor Displayed when the SD memory card is in analyses the stored ECG data the card slot T Full 30 second waveform W Battery level indicator U Measurement time indicator X ECG waveform Y Heart rate bpm beats per minute Note During measurement the screen displays the ECG waveform and the progress bar at the bottom of the screen displays measurement progress and a guide to the heart rate EJ Depending on the waveform situations can occur in which the device cannot assess and display the heart rate during the measurement
18. ECG data stored on the SD memory card SD memory error Cannot write data An error occurred while trying to save ECG data on the SD memory card Format the SD memory card Refer to p 19 Copy any important data to a PC before formatting the SD memory card as all data on the card will be erased Use a new different SD memory card Always turn off the unit before removing or inserting SD memory cards Error formatting SD memory An error occurred when formatting the SD memory card Use a new different SD memory card Always turn off the unit before removing or inserting SD memory cards SD memory error SD memory unknown The SD memory card may be damaged Format the SD memory card Refer to p 19 Copy any important data to a PC before formatting the SD memory card as all data on the card will be erased Use a new different SD memory card Always turn off the unit before removing or inserting SD memory cards SD memory full Please delete unnecessary data The SD memory card is full and there is not enough space to save new ECG data The number of data in SD is over the limit Please delete unnecessary data The SD memory card is full and there is not enough space to save new ECG data Either delete unnecessary data or use anew SD memory card Always turn off the unit before removing or inserting SD memory cards Device error The unit may ha
19. NIZA Zs HCG 801 E book Page 1 Tuesday December 13 2011 5 35 PM OMRON ice 801 c oye MENU lt A WE OK Portable cordless single channel ECG Monitor Model HCG 801 e Instruction Manual EN Thank you for purchasing the OMRON Portable ECG Monitor Before using this unit for the first time please be sure to read this instruction manual carefully and use the unit properly Please keep this instruction manual on hand for future reference OMRON assumes no responsibility for personal injury or damage All for Healthcare sustained by or through use of this product ian id WZ on a HCG 801 E book Page 2 Tuesday December 13 2011 5 35 PM Contents Before Using the Unit INtFOQUUCUON seis scsi cet eT et RA wx ae EEE a A Lee A ne Sot ee aa 3 INt nded USE E AE EEA E sds an E 3 Notes on Safety eaii ehga one n na eaae nan E deaa aAa EA TAPANA e ka san on ik y bonn kn sa EAR a SNEEN 4 T KAOW YOUR UN aso si secs eeraa don ae n na ka dane aonar EEA TE ene Voua aaen SE 6 Operating Instructions 2 Inserting and Replacing Batteries ccccccsseeeesesseeeeseesesneeeeeeeeesneeseeeeeeeees 10 3 Setting the Date and Time cecccccceseeeeeeeeeeneeeeeeeeeeeeeeeeeeeneeseesesneeeeeeeeesnensens 13 4 Using SD Memory Card cceccccceseeeneeeeeseeeeeeseeneeeseseseneeseeseseneeeeeseeseeeseeesseeees 15 4 1 Inserting and Ejecting SD Memory Card cccccececceeeeceeceeeeeeeceeee
20. age 43 Tuesday December 13 2011 5 35 PM Press the OK button The ECG data is copied to the SD memory card Copying Caution SD memory Never remove the SD memory card while data is being DO NOT REMOVE SD copied to it If the SD memory card is removed while data is being copied the data may be lost or damaged Notes e The copied data is displayed and the screen from step 1 appears If the same ECG data already exists on the SD memory card the data is not copied 43 lt d 7 A HCG 801 E book Page 44 Tuesday December 13 2011 5 35 PM 9 Managing ECG Data 9 3 Copying data from the SD memory card to a PC 44 a Copying data from the SD memory card to a PC 1 Please follow these instructions to copy data from the SD memory card to a PC Make sure the PC is equipped with an SD memory card port or connect a commercially available SD memory card reader writer to your PC Create a new folder on your PC where you want to save a copy of the ECG data Insert the SD memory card and browse to the SD memory card data as explained in the instruction manual of your PC and or software The ECG data is located in the ncg801 data folder where stands for the character of a removable disk Select all files and copy them in the folder you have created earlier 2 When copying is finished remove the SD memory card The SD memory card can now be formatted as described in
21. ctor for advice 21 a p SI on e gt HCG 801 E book Page 22 Tuesday December 13 2011 5 35 PM 6 Taking a Measurement 1 22 e Press the D Q button to turn the unit on The unit displays a reminder that self measurement is not the same as medical diagnosis and then the guidance screens are displayed The guidance screens are displayed twice Note You can press the START button to begin a measurement even while the guidance screens are being displayed Make sure that you are in a relaxed position The ideal posture is one where you are seated comfortably with your back straight Note You can also take a measurement while you are standing or while lying down Place your finger so that it fits closely over the two Fit finger closely on the finger electrodes electrodes Notes Even if you are left handed use your right hand to take a measurement e Take care not to press the START button until you are ready to take the measurement x Do not press START button until ready to take measurement p WZ on ie HCG 801 E book Page 23 Tuesday December 13 2011 5 35 PM 6 Taking a Measurement 4 Place the chest electrode on bare skin about 5 cm below your left nipple Notes Make sure that you are relaxed and that your chest is free of tension Press the chest electrode close against your bare chest Do not place the electrode on clothing as thi
22. d Guarantee card l Please be sure to read this instruction manual carefully Note Specifications may be changed without prior notice This device supports SDA standard SD memory cards e OMRON Healthcare Inc is a member of the SD Card Association e Uses bitmap font from Ricoh Co Ltd The SD logo is a registered trademark 52 e o WZ on ie HCG 801 E book Page 53 Tuesday December 13 2011 5 35 PM 12 Technical Data 0 1 97 This device fulfills the provisions of EC directive 93 42 EEC Medical Device Directive Important information regarding Electro Magnetic Compatibility EMC With the increased number of electronic devices such as PC s and mobile cellular telephones medical devices in use may be susceptible to electromagnetic interference from other devices Electromagnetic interference may result in incorrect operation of the medical device and create a potential unsafe situation Medical devices should also not interfere with other devices In order to regulate the requirements for EMC Electro Magnetic Compatibility with the aim to prevent unsafe product situations the EN60601 1 2 standard has been implemented This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical device This medical device manufactured by OMRON HEALTHCARE conforms to this EN60601 1 2 2007 standard for both immunity and e
23. e 21 Tuesday December 13 2011 5 35 PM 5 Important Notes on Taking a Measurement In order to obtain a good ECG reading it is important that measurements are taken correctly Before taking a measurement for the first time read these instructions carefully and make sure you observe the following points each time you take a measurement Make sure that the electrodes are directly touching your skin e 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 unreliable so be sure to check their position before taking a measurement Refer to p 22 and p 23 e 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 you have problems applying the unit so that the chest electrode is flat against your chest please ask your do
24. ed with other commercial wastes for disposal This product does not contain any hazardous substances Disposal of used batteries should be carried out in accordance with the national regulations for the disposal of batteries 53 2 N WZ O a HCG 801 E book Page 54 Tuesday December 13 2011 5 35 PM 13 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 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 allowing blood to fill up the heart again S Left atrium i Right atrium Left ventricle Right ventricle Septa 7 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 mon
25. ensive care units or operating rooms When using this unit in hospitals or other medical facilities use the unit under the supervision of your doctor This unit may affect the other medical devices and vice versa Do not use with a defibrillator Do not use in the presence of flammable anesthetics drugs or pressurised oxygen such as in a hyperbaric chamber ultraviolet steriliser or oxygen tent Do not attempt self diagnosis of the measurement results and analysis always consult your doctor Self diagnosis may lead to a deterioration in your condition Do not use on people with sensitive skin or allergies This may result in exanthema skin irritation or eczema e Keep out of reach of small children and people who can not express their consent Do not use for any purpose other than obtaining an electrocardiograph Do not expose the unit to strong shocks or vibrations or drop or step on the unit p S Ea HCG 801 E book Page 5 Tuesday December 13 2011 5 35 PM ki Notes on Safety W Do not use batteries of a type other than that specified in this manual Do not apply over clothing or touch the electrodes with your left hand Do not take measurements when there are drops of water on your skin such as from sweat or after bathing Do not take measurements where the unit will be exposed to strong electromagnetic forces Caution e Do not expose the unit to static electricity Always disperse
26. ensseeeeeees 12 Technical Data ret rokari nan karin ana tas ena padon senat san sak ad bbsosade s n sans an pan nn PAS kaki ao ES sAai kanon 13 General Information About the Heart and ECG Measurements 54 Yo Yo 0 o0 Go Go Go o Go OONOQO ON WB a A HCG 801 E book Page 3 Tuesday December 13 2011 5 35 PM Introduction Your OMRON HCG 801 is an easy to use electrocardiograph unit that can record and store electrocardiogram ECG measurements of your heart rhythm Each ECG reading records about 30 second measurement and these ECG readings can help your doctor monitor your condition It also includes guidance screens to help you obtain good results when taking measurements The monitor is supplied with an SD memory card that can store up to 300 measurements which include the ECG data along with the date and time of measurement Storing ECG data on the SD memory card or in unit memory allows you or your doctor to view them later Intended Use Medical Purpose The device is used for recording electrocardiographic waveform when patient feels symptoms of arrhythmia Intended User Self recording by patient Patient Population It is not intended to use for infants weighing less than 10 kg Environment The device can be used anytime except in the cases stated in the sections of warnings and cautions in the instruction manual Measurement Parameter Electrocardiograph ECG Precautions for use Warni
27. esaeeeseseeeeeeaeeeseeaeeeseeeessneeeees 15 4 2 Formatting an SD Memory Card 0 ccccccecceeeeeeeeeeeeeeeeeeeeeeeeeeeeecaaeeeesaaeeeseeeeeseeaeeeseeaeeesenaeeeseeeeeess 19 5 Important Notes on Taking a MeaSurement cccceceessseeeeeeeeeeeeeenenseneneees 21 6 Taking a Measurement Te Displaying ECG Dataies cic ccicvccisectecsesnccscerssenceceeessccncetessseenntereesaaecerceeteneteers 8 Adjusting the Settings 1 Basic Operation ian elev man cheese Gh oue Po ai NO aa aada a iadaaa aaa eaa aa a Date and Time Brightness eeererrrooen Contrast oo eee Language ccceseeeeee Date Format Messages ERKO NITTI Ke EA NE OE kn a ka E e at E YE on SETE ke sa 9 Managing ECG Data w i iriktri aki kree seke risan aka anan sink ans iab in kk akan apk kaa pakab ski a anka kn 9 1 Erasing EGG Datan inson iana a ava ire PO Ao eae zako tains eat 9 2 Copying Data to an SD Memory Card 9 3 Copying data from the SD memory card to a PC eeecceeeeceeeeeneeeeeeeeeeseeeeseeeeeeseeeeeseeeeeeeeieeeeeeaee 44 Care and Maintenance 10 Care and Maintenance ccccccessscececcssnseeeeeeecsenseeeeeseanseneesseeesnseeeesenanseeeees 10 1 Lists and Explanations of Messages 1072 TrouUbl SAOOU NA Q ooo ee vase eee age iota ov ke Tank ever ea te dey waar cea ee an vid e aa e ene ate saaa D 11 Maintenance and Storage ccccccesssseeeeeeeeeceneeeeeseeeeeeeeseeseeeeeeesseeeeen
28. ess the Y O button and select YES then press the OK button S The ECG data is erased and the screen from step 1 i highlighted appears Note If you press the OK button after selecting NO the screen from step 1 appears Important Never remove an SD memory card while data is being erased 41 a p cD e as A HCG 801 E book Page 42 Tuesday December 13 2011 5 35 PM L ai 9 Managing ECG Data 9 2 Copying Data to an SD Memory Card You can copy ECG data from the unit s internal memory to an SD memory card This allows you to copy data to the SD memory card if measurements have been taken while the SD memory card was not inserted Note The unit s internal memory can only store a maximum of five measurement results 1 Press the W button and select Data copy to SD E Date format SHessage i verwrite mErase all data gt lData copy to SO je 2 Press the OK button The conformation message Copy data into SD is displayed E Az l Data copy to SD Copy data into SD 3 Press the W L button to select YES Notes By default NO is e If the SD memory card is full the Overwrite data highlighted message may appear Refer to p 38 for details e ECG data stored on an SD memory card can be damaged by static electricity and other causes Copy data to PC or other device for additional safety 42 a p gr go Zi ki A HCG 801 E book P
29. hysical EN 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 55 p 4 HCGS01 E fm Page 56 Friday January 6 2012 5 59 PM S a Zi Manufacturer OMRON HEALTHCARE Co Ltd 53 Kunotsubo Terado cho Muko Kyoto peel 617 0002 JAPAN EU representative OMRON HEALTHCARE EUROPE B V Scorpius 33 2132 LR Hoofddorp EC THE NETHERLANDS www omron healthcare com OMRON HEALTHCARE Co Ltd Mie JAPAN Production facility OMRON HEALTHCARE UK LTD Opal Drive Fox Milne Milton Keynes MK15 ODG U K OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH Subsidiary John Deere Str 81a 68163 Mannheim GERMANY www omron medizintechnik de OMRON SANTE FRANCE SAS 14 rue de Lisbonne 93561 Rosny sous Bois Cedex FRANCE C 0197 Made in Japan IM HCG 801 E 05 1 1 2011 1647415 5E H Mika
30. itor when combined with a medical examination can help your doctor monitor your heart condition Conditions such as arrhythmia and Ischemia can only be diagnosed by a doctor through a special examination 54 a p ie HCG 801 E book Page 55 Tuesday December 13 2011 5 35 PM L 13 General Information About the Heart and ECG Measurements W 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 Ventrcular contraction A N QRS complex ZAY 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 the impulse over the ventricles and the beginning of their contraction This is known as the QRS complex The third peak indicates the activity as the heart relaxes re polarization and is known as the T wave Atrial contraction P 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 are skipped heartbeats premature contraction an abnormally rapid tachycardia or slow bradycardia pulse This can be caused by heart disease ageing p
31. missions Nevertheless special precautions need to be observed Do not use mobile cellular telephones and other devices which generate strong electrical or electromagnetic fields near the medical device This may result in incorrect operation of the unit and create a potentially unsafe situation Recommendation is to keep a minimum distance of 7 m Verify correct operation of the device in case the distance is shorter Further documentation in accordance with EN60601 1 2 2007 is available at OMRON HEALTHCARE EUROPE at the address mentioned in this instruction manual Documentation is also available at www omron healthcare com Correct Disposal of This Product Waste Electrical amp Electronic Equipment This marking shown on the product or its literature indicates that it should not be disposed of with other household wastes at the end of its working life To prevent possible harm to the environment or human health from uncontrolled waste disposal r EN please separate this from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources Household users should contact either the retailer where they purchased this product or their local government office for details of where and how they can take this item for environmentally safe recycling Business users should contact their supplier and check the terms and conditions of the purchase contract This product should not be mix
32. n the unit can find none or only sleight deviations from normal This data can be saved by selecting Yes and pressing the OK button Data is stored This message will be displayed when the unit can find moderate deviation from normal The unit will automatically store the data for future analysis by your doctor Data is stored Please show your Dr This message will be displayed when the unit can find significant deviation from normal The unit will automatically store the data for future analysis by your doctor 27 a p 4 2 N Z 7 A HCG 801 E book Page 28 Tuesday December 13 2011 5 35 PM 7 Displaying ECG Data The GRAPH menu is used to display the list of ECG data stored on the SD memory card or in unit memory 1 Press the MENU button while the unit is turned on the GRAPH menu is highlighted If you then press the OK button the list of ECG data is displayed 2 Select the ECG data you wish to view from the GRAPH menu list then press the OK button to display the detailed view of the waveform A si 1 2008 15 00 E 4 1 05 15 00 3 1 05 15 00 27 1 05 15 00 14 1 05 15 00 Each stored ECG data is displayed by date time and a character representing the measurement result refer to p 27 for the overview of character and measurement result ak 28 a p li e a SO HCG 801 E book Page 29 Tuesday December 13 2011 5 35 PM ki 7 Displaying ECG Data W P
33. ned off Note If you forget to turn off the power the unit will turn itself off automatically after five minutes p HCG 801 E book Page 15 Tuesday December 13 2011 5 35 PM L 4 Using SD Memory Card The unit includes an SD memory card for storing ECG data which can then be viewed by your doctor later This section describes how to insert and eject an SD memory card and how to format a card so it can be used to store ECG data Notes lf you need to purchase a new SD memory card consult your Omron Customer Service Department Tel 0870 7502771 e Do not store data other than ECG data from the unit on the card 4 1 Inserting and Ejecting SD Memory Card The SD E3 mark is displayed in the top right corner of the screen while the SD memory card is inserted and the unit is turned on Inserting the SD memory card 1 Check that the unit is turned off Caution Never insert an SD memory card while the unit is turned on 15 a 4 NZ as HCG 801 E book Page 16 Tuesday December 13 2011 5 35 PM ai 4 Using SD Memory Card 2 Open the SD memory card slot cover and insert the SD memory card into the slot Notes OMRON ce 801 e Check that the card is correctly aligned and insert it into the slot as shown A a oe o7 ROA e Back to front Upside down Back to front and upside down e Insert the card until it clicks into position
34. ngs and cautions described in the instruction manual should be observed Important Please note that while the measurements from an ECG monitor are a useful guide for your doctor they cannot detect all changes in heart EN conditions Always consult your doctor if you notice any change 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 illustrations used in this manual may differ slightly from the appearance of the actual product a p S a A HCG 801 E book Page 4 Tuesday December 13 2011 5 35 PM Notes on Safety This unit is designed for monitoring the ECG waveform Never use the unit to monitor vital signs and acute events Self diagnosis and treatment is dangerous The measurement results are for monitoring purposes only and should never be used as a basis for starting or modifying treatment without independent confirmation by medical examination The values displayed by the unit 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 This unit has no function to detect pacing spikes For a person with a cardiac pacemaker there are cases where pacing spikes are recorded or not recorded Warning e Do not use the unit in int
35. omes loose or the conditions change during measurement the measurement may not be correct Important Keep still and do not move until the measurement is complete WZ ie A HCG 801 E book Page 25 Tuesday December 13 2011 5 35 PM L ki 6 Taking a Measurement W A measurement result message is displayed when AM g 1 2005 15 00 E the measurement has been completed Refer to p Stable waveform 27 for details If you press the OK button while the result message is displayed the list of ECG data stored on the SD Heart rate 60min memory card or unit is displayed Store data Yes No Note If the Please insert new batteries error message is displayed immediately after measurement the ECG data may not be Example result message stored If this happens please repeat the measurement after replacing the batteries 6 Press the D Q button for two seconds to turn the unit off The unit beeps then the power is turned off Note If you forget to turn the unit off it will automatically shut itself off after five minutes 25 d e SV Ea HCG 801 E book Page 26 Tuesday December 13 2011 5 35 PM A ai 6 Taking a Measurement W Common Causes of Inaccurate Measurement Results The following situations can result in inaccurate measurement results or errors e The index finger is not placed The unit is held incorrectly closely on the electrode The unit is being
36. rds Refer to 8 7 Date Format on p 36 1 Press the D Q Power Cancel button to turn the unit on When the unit is used for the first time or if the Date and Time setting has been reset the Date and Time setting screen is automatically displayed and the day digits are highlighted 2 Press the W D or Q A button to set the day Press the Y O button to increase the number Press the D A button to decrease the number a Zs ki 3 Setting the Date and Time HCG 801 E book Page 14 Tuesday December 13 2011 5 35 PM Press the OK button to confirm the day setting The day setting is set and the month setting is highlighted The display cycles through the settings day gt month gt year gt hour gt minute with each press of the OK button Note If the setting for the date format has been changed refer to 8 7 Date Format on p 36 the order in which items are highlighted may differ from the example above In the same way press the W C gt or J A button to set the month year hour and minute After you have confirmed the last item on the date and time setting press the OK button to complete the date and time setting 31 AE 2005 0 00 Note If you need to set the date and time again refer to p 30 32 Press the button for two seconds to turn off the power Press for two seconds The unit beeps then the power is tur
37. ress the WC button to move down the list and the J A button to move up The most recent measurement result is displayed at the top of the list and is automatically highlighted with any previous measurement results listed below it in chronological order When the SD memory card is in the SD memory card slot the list of ECG data stored on the card is displayed If there is no SD memory card in the card slot the ECG data stored in unit memory is displayed 3 Ifyou press the W C gt button you can scroll through Bf 1 2005 15 00 Be fr the ECG waveform Press the J A button to return to the previous waveform display Two waveforms are displayed the lower smaller waveform being a view of the whole 30 second measurement At the bottom of the screen is a bar indicating the progress of the measurement The current heart rate is shown in the lower right corner of the screen The shaded area in the progress bar indicates the section of the ECG waveform being displayed 4 Press the OK button again to view the measurement fl 5 1 2005 15 00 E dz comments and heart rate Stable waveform Note You can specify whether a result message is displayed or not Refer to p 37 for details Heart rate 60 min 5 Press the OK button once more to return to the GRAPH menu list Bou ap Fe 7 lt A HCG 801 E book Page 30 Tuesday December 13 2011 5 35 PM l 8 Adjusting the Settings
38. ry card that has been used by other devices e If a memory card error occurs Notes When you format an SD memory card any data stored on the card is erased Always copy any data you wish to keep to a computer before formatting an SD memory card When you format an SD memory card format it with the unit Do not format an SD memory card with a computer 1 Press the MENU button press the W button to select SET menu then press the OK button GRAPH men 2 Press the W button to scroll through the settings and select Formatting SD Formatting SD Z 7 A HCG 801 E book Page 20 Tuesday December 13 2011 5 35 PM ki 4 Using SD Memory Card 3 Press the OK button The message All data in SD will be deleted Format SD is displayed E E Formatting SD All data in SD Will be deleted Format SD 4 Press the W D button to select YES then press the OK button If you press the OK button while NO is selected the SD memory card will not be formatted By default NO is high lighted 5 Press the OK button A message warning you not to remove the SD memory card while it is being formatted is displayed and the SD memory card is formatted Formatting can take up to eight seconds to Formatting complete SD memory Caution DO NOT REHOVE D Never remove an SD memory card while it is being formatted eo 4 ie A HCG 801 E book Pag
39. s will result in an inaccurate measurement Chest electrode About 5 cm Press closely to your chest EN Female Locate the ECG monitor at the lower end of the breastbone and move horizontally to the left to the middle of the left part of the chest If necessary gently lift the breast and place the Chest Electrode under the left breast Unless the chest electrode comes in contact with the brassiere it is not necessary to remove it if you are unsure please consult your doctor Qa naa eannee ee nneee WZ on e Ea HCG 801 E book Page 24 Tuesday December 13 2011 5 35 PM Ei 6 Taking a Measurement 5 While maintaining the same posture press the START button Measurement starts During measurement Measurement ends The unit beeps every second About 30 seconds Re RE 15 00 A The measurement ends automatically indicated by 4 rapid beeps 60 bpn The measurement takes about 30 seconds to complete The unit beeps every second during measurement During measurement the screen displays the ECG waveform and the progress bar at the bottom of the screen displays measurement progress and a guide to the heart rate Depending on the waveform situations can occur in which the device cannot assess and display the heart rate during the measurement Notes e During measurement the device will only respond to the D Q button to discontinue the measurement e If the contact of the electrodes bec
40. this will happen you can choose to hide or display this message The default setting is to hide the message E fark Overwrite E Date format SHessage Display The current setting is displayed at the bottom of the screen 1 Press the Q A button or W C gt button to highlight Display or Hide then press the OK button to confirm your selection Caution While Hide is selected the unit will overwrite erase and replace the oldest measurement data with the results of the new measurement without displaying a message when the SD memory card or unit memory are full About the Overwrite message If you select Display the unit will display a message before you take a measurement asking if you want to overwrite existing data with the new measurement data Select Yes to overwrite the oldest ECG data with the results of the new measurement If you select No measurement is cancelled k 9 as A HCG 801 E book Page 39 Tuesday December 13 2011 5 35 PM L UI 9 Managing ECG Data 9 1 Erasing ECG Data Erasing All ECG Data You can use the SET menu to erase all the ECG data stored on the SD memory card or in unit memory Note If an SD memory card is inserted in the unit all data on the card will be erased 1 Press the W C gt button to scroll through the settings and select Erase all data HDate format Message o0vervrite Data copy to SD a
41. ure to reset it before using the unit again Any ECG data erased from the unit cannot be recovered The battery life can be confirmed in the upper right of the display oe Remaining power is low Full power Half remaining Replace the batteries with new ones Warning If battery fluid should get in your eyes immediately rinse with plenty of clean water Consult a doctor immediately EM Caution Do not use batteries not specified for this unit Do not insert the batteries with the polarities in the wrong direction Do not dispose of batteries in fire If battery fluid should get on your skin or clothing immediately rinse with plenty of clean water 11 p IZ O SO HCG 801 E book Page 12 Tuesday December 13 2011 5 35 PM Bi 2 Inserting and Replacing Batteries a e Remove the batteries from this unit 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 HCG 801 E book Page 13 Tuesday December 13 2011 5 35 PM e L 3 Setting the Date and Time Always set the date and time before using the unit for the first time Check the date and time are correct before using the unit reset them if necessary The date and time are important indicators of when a measurement was taken Note The date and time format can be changed to different territorial standa
42. ve been damaged or is otherwise unable to operate normally Turn the unit off then on again If this error still occurs consult your Omron Customer Service Department Tel 0870 7502771 HCG 801 E book Page 50 Tuesday December 13 2011 5 35 PM 10 Care and Maintenance 10 2 Troubleshooting Refer to this table for problems that do not result in a message on the display Nothing happens when you press the O button The batteries are worn out The batteries are inserted incorrectly Replace both batteries with new ones Insert the batteries with their polarities correctly aligned Measurement starts but the message Analysis impossible Please measure again appears The measurement data could not be analysed Check the instructions and repeat measurement Measurement finishes but no result is shown The electrodes are not making good contact with your finger or chest Check the instructions and repeat measurement Your body is too tense Relax and repeat the measurement Electrode contact was broken before 30 seconds of data has been recorded Make sure that your finger and chest maintain contact with the electrodes for the full 30 seconds of the measurement The chest electrode has been applied over clothing Apply the chest electrode to bare skin Your skin is dry Moisten your skin with a damp towel The ECG signal is too weak Make sure that
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