user manual Geratherm easy med
Contents
1. 2 Replace all batteries if the low battery indicator ap pears Cx 3 Remove the batteries if the unit will not be used for a long period of time 4 REMOVE all of the BATTERIES when utilising an AC adapter Note It is recommended that the same type of alkaline batteries be used to avoid incompatibility 32 Preparation for use af DE i b dk 2 REI Oo Ly A Keep batteries away from small children Do not throw batteries into fires they could explode Attaching the pressure cuff 1 Wrap the cuff around the left arm The arm should be bare 2 Fasten the cuff Don t pull it too strongly or make the GB cuff too tight The edge of the cuff should be approxi mately 1 inch from the crease of your elbow 1inch 2 3cm 3 Attach the cuff on the right arm as shown in the figure if it is not possible to measure on the left arm 1inch 2 3cm 33 Preparation for use Posture during measurement 1 Sit upright and ensure that the measuring site is at heart level Relax and retain a natural posture during measurement 2 Measure and record blood pressure at the same time every day to establish your blood pressure pattern AC adapter Use the device only with a medical approved stabi lized AC adapter input 230 V AC 50 Hz output 6 V DC 1A Note 1 No batteries are required during operation using the AC adapter 2 If AC adapter power is inter2. MEMORY button again you can view each of the saved values in the selected memory store 5 After viewing the saved measurements press MEMO RY again to switch back to the initial display 6 You can also switch back to the initial display by press ing the START STOP button 36 Storing data Erasing data 1 Press the SET button to select User 1 or 2 or 3 2 Press the MEMORY button to enter the Memory Mode 3 Press and hold the MODE amp SET buttons together all stored date in the selected user will be erased 4 To confirm the deletion press the MEMORY button and no date should appear DISPOSAL ing of the device and batteries mmm This product must not be disposed of together with domestic waste K Observe the applicable regulations when dispos All users are obliged to hand in all electrical or electronic devices regardless of whether or not they contain toxic substances at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner Please remove the batteries before disposing of the device unit Do not dispose of old batteries with your house hold waste but at a battery collection station at a recycling site or in a shop 37 Do not drop the unit It is not shock proof Do not modify or disas semble the unit or the arm cuff Do not twist the arm cuff Do not twist the arm cuf
3. be used to diagnose or treat health problems or to prescribe drugs If you have or suspect that you have a medical problem please seek immediate ad vice from your doctor Do not conduct any measurements if the temperature is low below 5 C or high over 40 C or if the relative humidity is beyond the range of 15 to 93 as this can lead to inaccurate readings e Wait 30 to 45 minutes before taking a measurement if you have just had a caffeinated drink or a cigarette Relax for at least 5 to 10 minutes before taking a meas urement Please wait 3 to 5 minutes between measurements so that your blood vessels can return to the state they were in prior to measurement You may have to adapt the waiting time to your personal physiology Itis recommended that you use the same arm for each measurement preferably the left and take the meas urement at about the same time every day Sit down comfortably with your elbows placed on the table and both feet on the ground Please do not inter lock your legs during the measurement Wrap the cuff snug around your upper arm and lay your arm on a flat surface at the same level as your heart Take the measurement at room temperature in a quiet and stress free environment The unit should not be moved or shaken during the measurement Please do not speak during the meas urement 27 A Precautionary measures e Please keep in mind that blood pressure nat
4. Fully Automatic Blood Pressure Monitor for the Upper Arm Geratherm easy med INSTRUCTION MANUAL GT 868UF C 0197 Contents Designated USC icici cccistcsccescicscescesssscdstosssoscsseties 26 Precautionary measures 0 0 0c ee 27 Wea rtarity PE AEE E E E ET 29 Information you should know before operating the unit 00 0 0 eee 30 About the unit Explanation of displays Preparation for use Installing replacing batteries Attaching the pressure cuff Posture during measurement Operations Setting the time and date Measuring blood pressure Storing data Recalling data Erasing data DiSPOSall REE EE A I PEA E EET 37 Care and maintenance 0 ce eee 38 Error MCSSAGES c60icicccessecsscesctsscsscesversestenssoscssetscs 40 Spoo OHO ege Ea 41 Quality Standardiin shiii 42 Symbol index Designated use This unit uses an oscillometric measurement method in order to measure systolic and diastolic blood pressure as well as the heart rate The measurement is conducted on the upper arm All values can be read on an LCD screen This unit has been developed for home use and should only be used by adults over 18 years of age with an arm diameter of 23 to 33 cm 9 to 13 inches 26 A Precautionary measures This manual and the product are not substitutes for visiting the doctor Neither the information contained herein nor this prod uct may
5. ction from structures objects and people 44 Annex Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environments listed below and should only be used in such environments immunity test EC 80601 Compliance Electromagnetic environment guidance testlevel__ level Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 Vrms Conducted RF P 150 kHz to 3 Vrms d 1 2 P IEC 61000 4 6 39 MHz 3 Vim Radiated RF d 1 2 P IEC 61000 4 3 50 MHzto 3 vim 80 MHz to 800 MHz 2 5 GHz d 23 P 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 recom mended separation distance in metres 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 ofequipment marked A with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propaga tion is a
6. e monitor should be 3 3 metres 43 Annex Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environments listed below and should only beused in such environments Emissions test Compliance Electromagnetic environment guidance RF energy is used only to maintain device s operation Therefore its RF emissions are so RF emissions CISPR 11 Group 1 low that it s not likely to cause any interference in nearby electronic equipment febamisslons GISRRM piss The device is suitable for use in all establish Harmonic emissions esa ments including domesticestablishments IEC 61000 3 2 baat and those directly connected to the public low voltage power supply networkthat supplies Voltage fluctuations flicker Toonaga buildings used for domestic purposes emissions IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environments listed below and should only beused in such environments IEC 60601 Compliance Electromagnetic environment Immunity test test level level guidance Floors should be wood concrete or 6kV contact 6kVcontact ceramic tile If floors are covered with 8KV air 8kV air synthetic material the relative humidity Electrostatic discharge ESD IEC PIDE should be at least 30 Power frequenc
7. f A Care and maintenance Avoid thinner benzine and other harsh cleaners Keep the unit ina suitable place Avoid high temperature direct sunlight high moisture and dust Remove the batteries if the unit will not be used for a long time Do not press the START STOP button if the cuff has not been properly wrapped around the arm 39 Error messages D Replace batteries Replace all 4 batteries with new ones Insert the batteries in correct polarities Appears when measurement error oc curs or blood pressure value is displayed EE excessively low or high Measure again Wrap the cuff correctly and keep the arm still during measurement Air circuit deviation Cuff tube may not be Et plugged into monitor correctly Check cuff connection Measure again E2 Pressure exceeds 300 mmHg Turn the unit off to clear then measure again E3 Measurement data that result in an error message Measure again EP Return the device to your local distributor or to Geratherm 40 Specifications Model No GT 868UF Display System Liquid Crystal Display Measuring Method Oscillometric 4 alkaline AA type batteries 1 5 V Power Source or AC adapter Input 230 V AC 50 Hz Output 6 V DC 1A Measuring Pressure 0 300 mmHg Range Pulse 40 199 beat
8. ffected by absorption and reflection from structures objects and people Guidance and manufacturer s declaration electromagnetic immunity a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device b _ Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 Vim wal Geratherm Medical AG Fahrenheitstrasse 1 98716 Geschwenda Germany C 0197 45
9. he product away from children and do not place the hose around the neck 28 A Precautionary measures Measuring too frequently may result in circulatory dis orders which can cause unpleasant sensations such as localised bleeding under the skin or temporary numbness in your arm These symptoms do not usu ally last long However if you have not recovered after some time please consult your doctor e Please take into consideration the electromagnetic compatibility of the unit e g disruptions to the power supply radio frequency interference etc see annex Please only use the unit indoors To avoid inaccurate results due to electromagnetic interference between electrical and electronic equipment please do not use the unit near mobile phones or microwave ovens In the case of devices whose maximum power exceeds 2 W the minimum distance from your blood pressure monitor should be 3 3 metres The unit is not waterproof Never immerse this instru ment in any liquids Do not use the instrument if you think it is damaged or if you notice anything unusual Warranty The warranty for this blood pressure monitor is valid for any error on the part of the manufacturer under normal use for 3 years from the date of purchase If your unit does not function properly due to defective parts or as sembly we will repair it free of charge With the exception of the battery and cuff all parts of the unit are subject to this warrant
10. neral a lower blood pressure reading is better un less it causes unpleasant symptoms such as fainting and or lightheadedness What are systolic and diastolic pressures Systolic pressure is the highest pressure at the height of the heart s contraction Diastolic pressure is the lowest pressure when the heart is resting Fluctuation and variation in blood pressure The following factors will influence blood pressure meas urement results and cause variations Bathing Breathing Conversation Drinking alcohol Ex ercise Moving Mental tension Eating Temperature changes Thoughts Smoking etc About the unit ACCESS FOR POWER SUPPLY P LCD DISPLAY SET BUTTON RECALL MEMORY BUTTON MODE BUTTON START STOP BUT CUFF CONNECTION ARM CUFF il AA 1 5 Vx4 ALKALINE BATTERIES The cuff is designed to fit arm diameters between 23 and 33 cm 9 to 13 inches 31 About the unit Explanation of the display LOW battery a l H icon Pulse symbol Gp P og rate rregular heartbeat l i WHO pressure detector ev a a bar indicator con for users 1 2 3 KH _ Diastolic Tate Puls rate Hour Minute Day Month Number of memory spaces Preparation for use Installing replacing batteries 1 Insert the batteries into the battery compartment match ing correct polarities and
11. rupted during meas urement the unit must be reset by disconnecting the AC adapter from the unit 3 Only use medical approved adapters that com ply with the specifications in this manual Using other adapters could cause damage your blood pressure monitor 34 Operations Setting the time and date 1 Press the SET button to select memory store 1 2 or 3 2 Press the MODE button month starts flashing Press the SET button to set the correct month 3 Press the MODE button again date starts flashing Press the SET button to set the correct date 4 Press the MODE button again hour starts flashing Press the SET button to set the correct hour in 12 hour format 5 Press the MODE button again minute starts flashing Press the SET button to set the correct minute 6 Press the MODE button again to confirm the time and date Measuring blood pressure 1 Wrap the cuff around the arm refer to Attaching the pressure cuff 2 Sit upright on a chair refer to Posture during meas urement 3 Press the SET button to select a particular memory store number 4 Then press START STOP to start automatic meas urement When taking repeat measurements be sure to select the same memory store number before pressing START STOP 5 The cuff is inflated When the pulse is detected the PULSE symbol will s
12. s per minute Accuracy Pressure 3 mmHg Pulse 5 Inflation Automatic Deflation Automatic exhaust valve Memory 3 memory stores with 30 storage spaces each total 90 stored values Display LCD date time pressure and pulse Low Battery Indicator yes Automatic z 5 switch off approx 1 minute after last operation Battery Life around 300 operations IP Classifi IP22 effective against solid foreign alion objects with a finger protected against dripping water Cuff Size 23 to 33 cm 9 to 13 inches Operating 5 C to 40 C RH 15 to 93 Environment 41 F to 104 F oe 25 C to 70 C RH lt 93 ment 13 F to 158 F Dimensions 110 x 150 x 80 mm W x D x H Weight approx 265 g including batteries Specifications are subject to change without notice for purposes of product improvement 41 Quality standard Geratherm is certified in accordance with Council Direc tive 93 42 EEC andEN ISO 13485 and is entitled to af fix the CE mark C 0197 Notified Body T V Rheinland LGA Products GmbH The blood pressure monitor conforms to EN 1060 1 Non invasive sphygmomanometers part 1 General requirements and EN 1060 3 Non invasive sphygmomanometers part 3 Supplementary requirements for electromechanical blood pressure measuring systems EN 1060 4 Non invasive sphygmomanometers Part 4 Test procedures to determine the overall system accu racy of automated non invasive sphygmomanome
13. tart flashing 6 After the measuring procedure has been completed the blood pressure values systolic pressure and di astolic pressure along with the pulse and WHO clas sification indicator will be shown on the display for 1 minute After approx 1 minute without being used the unit will automatically switch off To interrupt the measurement you may press the START STOP buttons The cuff will deflate immedi ately after a button is pressed 35 Operations ig oF ora Gd 6g Irregular Heartbeat Detector If the symbol Yh appears it means the unit has detected an irregular pulse during measurement If the symbol ap pears regularly please consult a qualified doctor for pro fessional advice Storing data After each blood pressure measurement the blood pres sure values pulse rate time and date will be automati cally stored Each of the three memory stores saves the latest 30 measurements If more than 30 measurements are saved the memory will automatically delete the earli est values Recalling data 1 Press the MEMORY button A particular memory store will appear on the display 2 Press the SET to find the correct memory store 3 Press the MEMORY The average value of the last three measurements is shown by the following symbol A If no values have been stored nothing will appear on the display The most recently measured value will be displayed first 4 By pressing the
14. ters Symbol index Follow the instructions r torusa Type BF Equipment an Batch code mm yyyy Keep dry month year 93 Store at a max relative humidity of 93 Serial number A 770 C Store between 25 C and 70 C Manufacturer Bi Gy The device must not be disposed of with household waste Caution Read the instruction manual gt 2 E se Px 42 Annex Information on electromagnetic compatibility EMC Electronic devices such as PCs and mobile phones can lead to the exposure of medical devices in operation to electromagnetic interference from other devices This can lead to malfunction of the medical device and create a potentially unsafe situation Medical devices should also not interfere with any other devices The EN 60601 1 2 standard regulates the requirements for EMC electromagnetic compatibility and defines the levels of immunity to electromagnetic interference and the maximum electromagnetic emission levels for medi cal devices This blood pressure monitor which is manufactured by Geratherm Medical AG complies with the EN 60601 1 2 standard in relation to both immunity and emissions However special precautions should be observed please only use the device indoors and not in the vicinity of mobile phones or microwave ovens In the case of de vices whose maximum power exceeds 2 W the minimum distance from your blood pressur
15. urally varies depending on the time of day and is affected by many different factors Blood pressure is usually highest at work and reaches its lowest level during the sleep phase Blood pressure measurements should be assessed by a doctor or trained healthcare professional who is fa miliar with your medical history If you use the unit and regularly record the results please keep your doctor informed with regard to the ongoing changes in your blood pressure f you suffer from a cardiovascular disease such as herosclerosis diabetes a liver or kidney disease severe hypertension or peripheral circulatory disor ders etc please consult your doctor before using this unit o This unit is not suitable for use by people with cardiac arrhythmias or pregnant women The blood pressure measurements conducted with this unit are equivalent to measurements obtained by a trained observer in accordance with the values achieved using the cuff stethoscope auscultation method and are within the specified EN 1060 4 stand ard limits If the cuff causes any discomfort during the measure ment press the START STOP button to turn off the unit immediately Ifthe pressure is over 300 mmHg and the cuff does not deflate automatically pull off the Velcro strap to detach the cuff Do not use this appliance on infants children or per sons who cannot express their own intentions To avoid accidental strangulation keep t
16. y Damage caused by im proper handling of your unit is not guaranteed We recommend that the accuracy of the unit be checked after 2 years from manufacturing date by an authorized laboratory This checking procedure is not a service provided under the warranty 29 Information you should know before operating the unit What is blood pressure A force is created by the heart as the ventricle forcibly ejects blood into the blood vessels and through the vas cular system Another force is created by the arteries as they resist the blood flow Blood pressure is the result of these two forces Is my blood pressure normal See the following blood pressure classification chart released by the WHO World Health Organization for evaluation of your blood pressure level sa a 3 e 95 6pww 31403Sse1a 90 85 Severe Hypertension Grade 3 Moderate Hypertension Grade 2 80 Optimal Mild Hypertension Grade 1 120 130 140 150 170 180 Systolic mmHg Classification of Systolic Diastolic Colour blood pressure mmHg mmHg indicator monitor Optimal lt 120 lt 80 green Normal 120 129 80 84 green High Normal 130 139 85 89 yellow Grade 1 140 159 90 99 red Hypertension Grade 2 160 179 100 109 red Hypertension Grade 3 gt 180 gt 110 red Hypertension 30 Information you should know before operating the unit What about low blood pressure In ge
17. y Power frequency magnetic fields 50 60 Hz should be at levels characteristic of a 3 Am 3m magnetic field typical location in a typicalcommercial IEC 61000 4 8 or hospital environment Recommended separation distances between portable and mobile RF communication The device is intended for use in an electromagnetic environment where radiated RF disturbancesare under control User can help prevent electromagnetic interference by keeping the device at a minimum distance from portable and mobile RF communications equipment transmitters Below table details the maximum output power of transmitter Rated maximum Seperation distance according to frequency of transmitter m output power of transmitters in Watt 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2VP d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 1 2 23 10 38 3 8 73 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separa tion distance d in metres m can be estimated 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 At 80 MHz and 800 MHz the separation distance for the higher frequency NOTE 1 range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propaga tion is affected by absorption and refle
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