IMC-734 User`s Manual
Contents
1. TYPE B APPLIED PARTS Symbol for ENVIRONMENT PROTECTION Waste electrical products should not be disposed of with household waste Please recycle where facilities exist Check with your local Authority or retailer for recycling advice m l Symbol for MANUFACTURER C E 0197symbol for COMPILES WITH MDD93 42 EEC REQUIREMENTS wi Symbol for DATE OF MANUFACTURE Ec ree Symbol for EUROPEAN REPRESENTATION WARRANTY INFORMATION Only charge the cost of components and transport SERVICE CENTER Inspire Medical Corp Address No 7 Ln 57 Sec 1 Zhiyu Rd Shilin Dist Taipei City 111 Taiwan R O C Tel 886 2 28384177 Fax 886 2 28380392 www imedisource com thil anon HEALTH CO LTD No 3 Jin Ping Street Ya An Road Nankai District Tianjin 300190 China Tel 86 22 60526081 Tr JLotus Global Co Ltd 15 Alexandra Road London UK NW8 ODP Tel 0044 20 75868010 Fax 0044 20 79006187 ELECTROMAGNETIC COMPATIBILITY INFORMATION Table 1 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture s declaration electromagnetic emissions The IMC 734 is intended for use in the electromagnetic environment specified below The customer or the user of the IMC 734 should assure that it is used in such an environment Fall Compliance Electromagnetic environment guidance The IMC 734 uses RF energy only for its internal Kald function Therefore its RF RF emissions hr Group2. checking error LCD shows Er A Pressure sensor parameter error No response when Incorrect operation or Take out batteries you press button strong electromagnetic for five minutes or load battery interference and then reinstall all batteries MAINTENANCE 1 Do not drop this monitor or subject it to strong impact 2 Avoid high temperature and solarization Do not immerse the monitor in water as this will result in damage to the monitor 3 If this monitor is stored near freezing allow it to acclimate to room temperature before use 4 Do not attempt to disassemble this monitor 5 If you do not use the monitor for a long time please remove the batteries 6 It is recommended the performance should be checked every 2 years or after repair Please contact the service center 7 If the monitor becomes dirty please clear it with a soft dry cloth Do not use any abrasive or volatile cleaners 8 No component can be maintained by user in the monitor The circuit diagrams component part lists descriptions calibration instructions or other information which will assist the user s appropriately qualified technical personnel to repair those parts of equipment which are designated repairably can be supplied by us 9 The monitor can maintain the safety and performance characteristics for a minimum of 10 000 measurements or three years EXPLANATION OF SYMBOLS ON UNIT Symbol for CONSULT INSTRUCTIONS FOR USE Symbol for
3. BLOOD PRESSURE SBP DBP COLOR CLASSIFICATION mmHg mmHg INDICATOR oa fam ao ree High Normal 130 139 85 89 Grade 1 Hypertension 140 159 90 99 Grade 2 Hypertension 160 179 100 109 ORANGE Severe Hypertension Moderate Hypertension Mild Hypertension High normal BP Diastolic mmHg WHO ISH Definitions and Classification of Blood Pressure Levels Note It is not intended to provide a basis of any type of rush toward emergency conditions diagnosis based on the color scheme and that the color scheme is meant only to discriminate between the different levels of blood pressure 11 TROUBLESHOOTING 2 PROBLEM POSSIBLE CAUSE SOLUTION LCD shows low Low Battery Change the battery symbol N batteries LCD shows Er 0 Pressure system is unstable before Don t move and measurement try again pressure LCD shows Er 2 Fail to detect diastolic LCD shows Er 3 Pneumatic system blocked or cuff is too Apply the cuff tight during inflation correctly and try LCD shows Er 4 Pneumatic system again leakage or cuff is too loose during inflation LCD shows Er 5 Cuff pressure above 300mmHg Measure again LCD shows Er 6 More than 3 minutes after five minutes with cuff pressure If the monitor is above 15 mmHg still abnormal LCD shows Er 7 EEPROM accessing please contact the error local distributor or LCD shows Er 8 Device parameter the factory
4. land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the IMC 734 is used exceeds the applicable RF compliance level above the IMC 734 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the IMC 734 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m Table 4 For ME EQUIPMENT and ME SYSTEMS that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the IMC 734 The IMC 734 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the IMC 734 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the IMC 734 as recommended below according to the maximum output power of the communications equipment 20 Rated maximum Separation distance according to output frequency of transmitter power of transmitter m W a 12 P 12VP d 2 3NP 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2
5. might not meet its performance specifications or cause safety hazard if stored or used outside the specified temperature and humidity ranges in specifications 13 Please do not share the cuff with other infective person to avoid cross infection SETUP AND OPERATING PROCEDURES 1 BATTERY LOADING a Open battery cover at the back of the monitor b Load two AAA size batteries Please pay attention to polarity c Close the battery cover When LCD shows battery symbol fy replace all batteries with new ones A Rechargeable batteries are not suitable for this monitor Remove the batteries if the monitor will not be used for a month or more to avoid relevant damage of battery leakage the monitor the batteries and the cuff must be disposed of according to local regulations at the end of their usage 2 CLOCK AND DATE ADJUSTMENT a Once you install the battery or turn off the monitor it will enter Clock Mode and LCD will display time and date by turns See picture 2 amp 2 1 Np Dm 12 00 bok Foa bn ke Je 00 te 00 hard Picture2 Picture 2 4 Picture 2 2 Picture 2 3 Picture 2 4 Picture 2 5 b While the monitor is in Clock Mode pressing both the START and MEM button simultaneously a beep is heard and the month will blink at first See picture 2 2 Press the button START repeatedly the day hour and minute will blink in turn See picture 2 3 amp picture 2 4 amp pi
6. 1 emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment CISPR 11 suitable for use in all Harmonic Not establishments other emissions applicable than domestic and those IEC 61000 3 2 directly connected to Voltage the public low voltage fluctuations Not power supply network that flicker supplies buildings used for ar applicable emissions domestic purposes IEC 61000 3 3 Table 2 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer s declaration electromagnetic immunit The IMC 734 is intended for use in the electromagnetic environment specified below The customer or the user of the IMC 734 should assure that it is used in such an environment IMMUNITY test Electrostatic discharge ESD IEC 61000 4 2 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601test level 6 kV contact 8 kV air Compliance level 6 kV contact 8 kV air Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE SUPP
7. 2 Measuring accuracy 3mmHg 13 Heart pulse rate range 40 180times min accuracy 5 14 Environmental temperature for operation 5 C 40 C 15 Environmental humidity for operation lt 90 16 Environmental temperature for storage and transport 20 C 55 C 17 Environmental humidity for storage and transport lt 95 18 Environmental pressure 80KPa 105KPa 19 Battery life Approx 3 month with alkaline batteries and 3 min usage per day 20 a list of all components belonging to the pressure measuring system including accessories 1 Pump KPM14A or CJP31 C03A1 or MPDC3V 03 or KP PUMP 01 2 Value KSVO5A3 or CJV10 A03A1 or VLDC3V 02 3 LCD IMC 734 L01 4 Wrist Cuff 14cm 19 5cm 5 Sensor KD 2107 006G If you want to change these components please contact us NOTICE 1 Stay quiet calm and rest for 5 minutes before blood pressure measurement 2 The cuff should be placed at the same level as your heart 3 During measurement neither speak nor move your body and arm 4 Measuring on same wrist for each measurement 5 Please always relax a minimum moment of 1 to 1 5 minutes between measurements to allow the blood circulation in your arm to recover Prolonged over inflation cuff pressure exceed 300 mmHg or maintained above15 mmHg for longer than 3 minutes of the bladder may cause ecchymoma of your arm 6 Remove the batteries if the monitor will not be used for a month or more to avoid damage of battery leakage 7 This Electronic Sphygmomanometer is de
8. 5 GHz For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 21
9. LEON Advance IMC 734 Blood Pressure Monitorin B j f I I E PUL min Owner s manual DIA mmHg NPORTANINFOR MIN ene 2 CONTENTS AND DISPLAY INDICATORS 3 NE PEDER 4 CONTRAINDICATION rnnonvrvnnvnrrrnnnvrvnennvrvnersvrenersvrenersererevsenesesrenenenn 4 PRODUC T ES PI lue 4 SPECIFICATIONS 5 MIE 6 SETUP AND OPERATING PROCEDURES 7 1 BATTERY LOADING en ern ree eee a 7 2 CLOCK AND DATE ADJUSTMENT 8 3 CONNECTING THE CUFF TO THE MONITOR 9 4 APPLYING THE CGUPF janne nabaeainste 9 5 BODY POSTURE DURING MEASUREMENT eens 10 6 TAKING YOUR BLOOD PRESSURE READING eee 10 7 DISPLAYING STORED RESULT SL te eee 11 8 DELETING MEASUREMENTS FROM THE MEMORY 12 9 ASSESSING HIGH BLOOD PRESSURE FOR ADULTG 12 10 TROUBLESHOOTING 1 13 11 TROUBLESHOOTING 2 vett 14 MAINTENANCE 25 cccstecscnscccatoacbestaatetsibinccssapesiasiahstbanieteeesi tiseersi iets 15 EXPLANATION OF SYMBOLS ON UNE i kvittet 16 WARRANTY INFORMATION rrvrvennrvvrennrvrennvrvnerevrenerserenersererenserenenn 16 SERVICE AE 16 ELECTROMAGNETIC COMPATIBILITY INFORMATION 04 17 IMPORTANT INFORMATION NORMAL BLOOD PRESSURE FLUCTUATION All physical activity excitement stress eating drinking smoking body posture and many other activities or factors including taking a blood pressure measurement will influence blood pressure value Because of this it is mostly unusual to obtain i
10. ORTING Guidance and manufacturer s declaration electromag The IMC 734 is intended for use in the electromagnetic environment specified below The customer or the user of the IMC 734 should assure that it is used in such an environment test test level level environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the IMC 734 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Radiated RF 3 V m 80 separation distance IEC 61000 MHzto2 5 d 1 2 P 80 MHz to 800 MHz 4 3 GHz d 2 3VP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol E NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and
11. cture 2 5 While the number is blinking press the button MEM to increase the number Keep on pressing the button MEM the number will increase fast c You can turn off the monitor by pressing START button when the minute is blinking then the time and date is confirmed d The monitor will turn off automatically after 1 minute of no operation with the time and date unchanged e Once you change the batteries you should readjust the time and date 3 CONNECTING THE CUFF TO THE MONITOR The cuff is attached to the monitor when it is packaged Should the cuff become unattached align the two plugs and four brackets of the cuff with the plug sockets and bracket sockets of the monitor and press the cuff to the monitor until the plugs and brackets are securely attached 4 APPLYING THE CUFF a Place the cuff around a bare wrist 1 2cm above the wrist joint on the palm side of the wrist b While seated place the arm with the cuffed wrist in front of your body on a desk or table with the palm up If the cuff is correctly placed you can read the LCD display c The cuff must be neither too tight nor too loose Note e Please refer to the cuff circumference range in SPECIFICATIONS to make sure that the appropriate cuff is used e Measuring on same wrist each time e Do not move your arm body or the monitor during measurement e Stay quiet calm for 5 minutes before blood pressure measurement e Please keep the cuff clea
12. dentical multiple blood pressure readings Blood pressure fluctuates continually day and night The highest value usually appears in the daytime and lowest one usually at midnight Typically the value begins to increase at around 3 00AM and reaches to highest level in the daytime while most people are awake and active Considering the above information it is recommended that you measure your blood pressure at approximately the same time each day Please always relax a minimum moment of 1 to 1 5 minutes between measurements to allow the blood circulation in your arm to recover It is rare that you obtain identical blood pressure readings each time CONTENTS AND DISPLAY INDICATORS LCD display MEM button WHO Color Bar START button Cuff Date Time Display Alternating Low Battery Indicator 10 C dG 8 Systolic Pressure Irregular Heartbeat Symbol Ready to inflate indicator Blood Pressure level Classification Indicator Diastolic Pressure Pulse Rate Display Alternating INTENDED USE Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non invasive technique in which an inflatable cuff is wrapped around the wrist CONTRAINDICATION It is inappropriate for people wi
13. n If the cuff becomes dirty remove it from the monitor and clear it by hand in a mild detergent then rinse it thoroughly in cold water Never dry the cuff in clothes dryer or iron it Clean the cuff after the usage of every 200 times Is 9 recommended e Do not place the cuff around your wrist if the wrist has any inflammation acute diseases infections skin wounds 5 BODY POSTURE DURING MEASUREMENT Sitting Measurement Recommended Position a Sit upright b Place palm upside in front of you on a flat surface such as a desk or table with your elbow resting on a chair or table c The cuff should be at the same level as your heart d Placing your arm on the monitor s plastic case as shown in the picture to aid in maintaining a correct and still arm position 6 TAKING YOUR BLOOD PRESSURE READING a After applying the cuff and your body is in a comfortable position press the START button A beep is heard and all display characters are shown for self test See picture 6 Please contact the service center if segment is missing s 036 Bo 1 04 11 04 k d 3001 m 0 5 oggi Li Eg Ba OC we WE s n ae 2 IE Picture 6 Picture 6 1 Picture 6 2 Picture 6 3 b Then the monitor starts to seek zero pressure See picture 6 1 c The monitor inflates the cuff until sufficient pressure has built up for a measurement Then the monitor slowly releases air from the cuff and carrie
14. s out the measurement Finally the blood pressure and pulse rate will be calculated and displayed on the LCD screen separately Irregular heartbeat symbol if any and blood pressure classification indicator will blink on the screen as displaying blood pressure and the blood pressure classification indicator do not display as displaying pulse rate See picture 6 2 amp 6 3 The result will be automatically stored in the memory bank d After measurement the monitor will turn off automatically after 1 minute of no operation Alternatively you can press the START button to turn off the monitor manually e During measurement you can press the START button to turn off the monitor manually Note Please consult a health care professional for interpretation of pressure measurements 7 DISPLAYING STORED RESULTS a After measurement you can review the results in the memory bank by pressing the MEM button Alternatively you can press MEM button in Clock Mode to display the stored results If it no result stored LCD will show dashes as picture 7 while press the button MEM or START machine will turn off If there are results in the memory bank the LCD will display the amount of the results in the memory bank ae picture 7 1 IM m 5 Di m i 04 Of 6 M fe En 1 30 i370 Dar IDM wi m SB GAL EM TE VS TT 23 pi ta oc par a Picture 7 Pict
15. signed for adults and should never be used on infants or young children Consult your physician or other health care professionals before use on older children 8 Blood pressure measurements determined by this monitor are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by the American National Standard Institute Electronic or automated sphygmomanometers 9 Information regarding potential electromagnetic or other interference between the blood pressure monitor and other devices together with advice regarding avoidance of such interference please see part ELECTROMAGNETIC COMPATIBILITY INFORMATION 10 If Irregular Heartbeat IHB brought by common arrhythmias is detected in the procedure of blood pressure measurement a signal of will be displayed Under this condition the Electronic Sphygmomanometer can keep function but the results may not be accurate it s suggested that you consult with your physician for accurate assessment There are 2 conditions under which the signal of IHB will be displayed 1 The coefficient of variation CV of pulse period gt 25 2 The difference of adjacent pulse period20 14s and the number of such pulse takes more than 53 percentage of the total number of pulse 11 Please do not use the cuff other than supplied by the manufacturer otherwise it may bring biocompatible hazard and might result in measurement error 12 The monitor
16. th serious arrhythmia to use this Electronic Sohygmomanometer PRODUCT DESCRIPTION Based on Oscillometric methodology and silicon integrated pressure sensor blood pressure and pulse rate can be measured automatically and non invasively The most recent 60 measurements can be stored in the memory with date and time stamp The Electronic Sphygmomanometer corresponds to the below standards EN 60601 1 1990 A1 1993 A2 1995 Medical electrical equipment Part1 General requirements for safety EN 60601 1 2 2007 Medical electrical equipment Part1 General requirements for safety Collateral Standard Electromagnetic compatibility Requirements and tests EN 1060 1 1995 A2 2009 Non invasive sphygmomanometers Part 1 General requirements EN 1060 3 1997 A2 2009 Non invasive sphygmomanometers Part 3 Supplementary requirements for electro mechanical blood pressure measuring systems ANSI AAMI SP 10 2002 A1 2003 A2 2006 SPECIFICATIONS 1 Product name Blood Pressure Monitor 2 Model IMC 734 3 Classification Internally powered Type B applied part IPX0 No AP or APG Continuous operation 4 Machine size 87mm x 66 6mm x 25 3mm 5 Cuff circumference 14cm 19 5cm 6 Weight about 115g exclude batteries 7 Measuring method oscillometric method automatic air inflation and measurement 8 Memory volume 60 times with time and date stamp 9 Power source 2 x1 5V SIZE AAA batteries 10 Cuff pressure range 0 295mmHg 11 Range of measurement 30 280mmHg 1
17. ure 7 1 Picture 7 2 Picture 7 3 Picture 7 4 Picture 7 5 11 b And then the most recent result will be displayed with date and time stamp See picture7 2 Followed by the blood pressure and pulse rate will be shown separately Irregular heartbeat symbol if any will blink See picture7 3 amp 7 4 Press MEM button again to review the next result See picture7 5 In this way repeatedly pressing the MEM button displays the respective results measured previously c When displaying the stored results the monitor will turn off automatically after 1 minute of no operation You can also press the button START to turn off the monitor manually 8 DELETING MEASUREMENTS FROM THE MEMORY M When any result is displaying keep on pressing button MEM for three seconds all results in the memory bank will be deleted after three beep LCD will show dashes See picture 8 Press the button e MEM or START the monitor will turn off Picture 8 9 ASSESSING HIGH BLOOD PRESSURE FOR ADULTS The following guideline for assessing high blood pressure without regard to age or gender has been established by the World Health Organization WHO Please note that other factors e g diabetes obesity smoking etc need to be taken into consideration Consult with your physician for accurate assessment and never change your treatment by yourself Classification of blood pressure for adults Systolic mmHg
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