user manual Geratherm desktop
Contents
1. 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 po tentially 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 maxi mum electromagnetic emission levels for medical 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 pressure monitor should be 3 3 metres 39 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 RP ameslons Cis N Group low that it s not likely to cause any interfe2. 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 Conducted 3 Vrms RF IEC 150 kHz to 3 Vrms d 1 2 P 61000 4 6 80 MHz Radiated 3 Vim d 1 2 P RF IEC 80 MHzto 3 Vim aes eee 80 MHz to 800 MHz d 2 3 vP 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 0 Interference may occur in the A Vicinity ofequipment marked 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 propagation is affected 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 cord less 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
3. 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 an C 0197 www geratherm com 41
4. 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 2 P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 12 23 10 3 8 3 8 73 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation 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 transmit ter in watts W according to the transmitter manufacturer At 80 MHz and 800 MHz the separation distance for the higher fre NOTE 1 quency 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 40 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 TEC 60601 compl Immunity test test i cole Hance Electromagnetic environment guidance level ae Portable and mobile RF communications equipment should be used no closer to
5. the power key again After 3 beeps are heard the unit erases the record Press and release MEMORY key to choose the record that you wish to delete Press and hold the POWER key until the display shows Press and release the MEMORY key then the display shows dEL ALL Press and release the POWER key After 3 beeps are heard the unit erases all records 33 A Care and Maintenance Do not drop the unit It is not shock proof Do not modify or disassemble the unit or the arm cuff Do not twist the arm cuff Use a cloth mois tened with water or neutral detergent to clean the body of the unit and then wipe it dry 34 A Care and Maintenance Avoid thinner benzine and other harsh cleaners Keep the unit ina suitable place Avoid high tempera ture direct sunlight high moisture and dust Remove the batteries if the unit will not be used for a long time Do not press the POWER button if the cuff has not been properly wrapped around the arm 35 Error Messages The pressure measured was lower than 20 mm Hg Please measure again Excessive body movement is detected during measurement Please measure again Pumping error Please check cuff and try again The pressure can not be measured due to signal noise Please measure again The pumping pressure is higher than 300 mm Hg Please measure agai
6. Digital Blood Pressure Monitor for the Upper Arm Geratherm desktop INSTRUCTION FOR USE GP 6621 C 0197 Contents Designated Use Precautions ed Warranty eiei esna e E Information You Should Know Before Operating the Unit About the Unit Explanation of Display cceeceeeeeeeees 28 Preparation for Use Installing Replacing Batteries Attaching the Pressure Cuff Measuring Posture How to Operate the Unit Setting the Clock Measuring Blood Pressure Recalling Memories Erasing Memories Care and Maintenance Error Message Disposal Specifications Quality Standard Symbol Index Annex 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 and professional use and should only be used by adults over 18 years of age with an arm diameter of 22 32 cm 8 7 12 6 inches 24 A Precautions This manual and the product are not substitutes for visiting the doctor Neither the information contained herein nor this prod uct may 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 measu
7. athing Breathing Conversation Drinking alcohol Exercise Moving Mental tension Meals Temperature change Thoughts Smoking etc About the unit Explanation of Display Memory Date Systolic ue Preeti T T Ba MEMORY mm red vill Arrhythmia Pulse Liow Battery Detection 28 About the Unit LCD Display Memory Button The cuff is designed to fit arm sizes between 22 and 32cm 8 7 to 12 6 inches Preparation for Use Installing Replacing Batteries 1 Insert the batteries into the battery compartment Mg matching correct polarities and i 2 Replace all batteries if the et low battery indicator ap pears C Zw 3 Remove the batteries if A Si the unit will not be usedfor CA a long period of time Key 4 REMOVE all of the BAT k TERIES when utilizing the optional AC adapter Note It is recommended that the same type of alka line batteries be used to avoid incompatibility Keep batteries away from small children Do not throw batteries into fires they could explode 29 Preparation for Use Attaching the Pressure Cuff 4 Fasten the cuff Don t pull it Attach the cuff on the right Wrap the cuff around the left arm The arm should be bare skin strongly and make the cuff too tight The cuffs edge should be approximately 1 inch from crook of the arm hand as shown in the figure if it is not possible to measure on th
8. e left arm Measuring Posture 1 Sit upright and ensure that the measuring site is at heart level Relax and measure in a natural position 4inch 2 3cm SS 1inch 2 3cm Measure and record blood pressure at the same time every day to establish your blood pressure pattern AC Adapter accessory Use the device only with a medical approved stabi lized AC adapter Input 100 240 V AC 60 50Hz Output 6V DC 800mA Note A 1 No batteries are required during operation using the AC adapter 2 If AC adapter power is interrupted during meas urement the device must be reset by discon necting the AC adapter from the device 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 30 How to Operate the Unit 1 Setting the Clock To enter the setting mode by press an as ing and holding the memory key for we over 3 seconds The display will show a blinking year Press the power key to adjust the year when it is blinking Then press and release the memory ERI key again the month will appear and blink to be adjusted and then date hour and minute will fol aa low up as you press and release the gi memory key again To adjust the clock Press the memory key to adjust the values of the month date hour and minute whe
9. n Low battery Check and replace the 4 batteries if necessary Disposal Observe the applicable regulations when disposing of the device and batteries This product must not be disposed of together with domes tic waste 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 ac ceptable manner Please remove the batteries before disposing of the de vice 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 x 36 Specifications Model no Display System Measuring Method Power Source Measuring Range Accuracy Pressure Exhaust Memory Display Low Battery Indicator Auto Power Off Battery Life Protection Level Cuff Size Operating Environment Storage Environment Dimensions Weight GP 6621 Liquid Crystal Display Oscillometric 4 alkaline AA type batteries 1 5 V or AC adapter input 100 240 V AC 60 50 Hz output 6 V DC 800 mA Blood pressure 20 to 300 mmHg Heart pulse rate 40 to 200 pulse beats min Blood pressure Heart pulse rate 3 mm Hg pulse rate 5 Inflation Micro rolling pump Electric solenoid valve 85 sets LCD year date time pressure and pulse Yes 150 secs withou
10. n they are blinking 2 Measuring Blood Pressure eB Press and release the POWER key to start S5 measuring automatically eee a gt Initial display gt Pumping p a 7 pg gt Measuring and deg 80 ns ag a n Ue B Buzzer sounds U When the measurement is finished the display will show the measured blood pressure and pulse value Press the power key to turn off the unit Otherwise the unit will turn o automatically 150 seconds later 31 How to Operate the Unit A Note If the symbol aha appears it means the unit has detected irregular pulse during measurement If the symbol appears regularly please consult a qualified physician for professional advice 2i Bo 3 Recalling Memories Press and release the MEMORY key to recall the last read ing Example the no 7 memory The display will show the memorized pressure and pulse value 204s 03 Press and release the MEMORY key again to recall the no 6 memory g 6 g pJ AB Press and release repeatedly to read the no 5 4 3 2 1 4 T cD se 83 pressures 32 ca H 4 ow to Operate the Unit Erasing Memories You may erase one or all records in memory Delete one record 1 2 3 Delete all records 1 2 JEL Press and release MEMORY key to choose the record that you wish to delete Press and hold the POWER key until the display shows JEL Press and release
11. ons 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 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 26 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 assembly we will repair it free of charge With the exception of the battery and cuff all parts of the unit are subject to this warranty 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
12. procedure is not a service provided under the warranty 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 trans port system Another force is created by the arteries as they resist the blood flow Blood pressure is the result of these two forces What are systolic and diastolic pressures Systolic pressure represents the highest pressure at the height of the heart s contraction Diastolic pressure is the lowest pressure when the heart is resting Is my blood pressure normal See the following blood pressure classification chart re leased by the WHO World Health Organization for evalu ation of your blood pressure level Diastolic mm Hg Severe hypertension Grade 3 Moderate Hypertension Grade 2 Mild Hypertension Grade 1 6H ww 21103shg Optimal 27 Information you should know before operating the unit What about low blood pressure In general a lower blood pressure reading is better unless it causes some uncomfortable symptoms such as fainting and or lightheadedness Fluctuation and variation in blood pressure The following chart shows possible blood pressure fluctua tions during a 24hr period mmHg 160 140 120 stolic 100 stolic 80 60 r T T The following factors will influence blood pressure meas urement results and cause variations B
13. r ence in nearby electronic equipment amssione CISRRSN Giale The device is suitable for use in all establish Harmonic emissions GEER ments including domesticestablishments IEC 61000 3 2 ee and those directly connected to the public low voltage power supply networkthat sup Voltage fluctuations flicker ooties plies 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 6 kV contact 6kV contact or ceramic tile If floors are covered 8 KV air 8KV air with synthetic material the relative Electrostatic discharge ESD IEC EO humidity should be at least 30 Power frequency Power frequency magnetic fields 50 60 Hz oa En should be at levels characteristic of magnetic field mM ew a typical location in a typicalcommer IEC 61000 4 8 cial 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
14. rements 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 90 as this can lead to inaccurate readings 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 measurement 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 Place the unit at the level of the heart Relax your hand Your palm should be facing up 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 Please keep in mind that blood pressure naturally 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 profes
15. sional who is familiar 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 If you suffer from a cardiovascular disease such as atherosclerosis diabetes a liver or kidney disease 25 A Precautions severe hypertension or peripheral circulatory disor ders etc please consult your doctor before using this unit The performance of this device can be influenced as severe arrhythmias such as atrial or ventricular pre mature beats or atrial fibrillation are presented during measurement 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 POWER button to turn off the unit immediately If the 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 the product away from children and do not place the hose around the neck Measuring too frequently may result in circulatory dis orders which can cause unpleasant sensati
16. t any operation Around 250 measurements IP20 protected against foreign bodies lt 12 5 mm 22 to 32 cm 8 7 12 6 inches 5 C to 40 C RH 15 to 90 41 F to 104 F 25 C to 55 C RH 15 to 90 4 F to 122 F 171 mm x 139 mm x 54 mm around 550 g including batteries Specifications are subject to change for improvement without notice 37 Quality Standard Geratherm is certified in accordance with Council Direc tive 93 42 EEC and EN ISO 13485 and is entitled to affix 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 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 sphygmomanometers Symbol index Type BF Equipment Keep dry A Store between 15 ws and 90 R H Follow the instruc tions for use B a4 Batch code mm yyyy month year Serial number Store between 25 C and 55 C The device must not be disposed of with ea household waste PIE a Manufacturer Important Read the instruction manual 38 Annex Information on electromagnetic compatibility
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