Visomat Handy User Manual available in PDF format
Contents
1. visomai handy Cl Instructions for Use GB30 GB57 Contents Productinformation notes on use 32 Device description indicators 34 Abridgedinstructions on measurement 36 Operation of thedevice 1 Setting up the device 38 Fitting the cuff 38 Positioning the device correctly 39 Inflating the cuff 41 Measuring blood pressure 42 Irregular pulse waves 43 Memory recall 44 Delating the memory 44 morantiforain Basic rules for blood pressure measurement 45 Other points to note 45 e Wrist circumference 45 e Cardiac arrhythmia 45 Frequency of cardiac pacemakers 46 Pregnancy 46 e Medicines 46 e Intravenous supply systems 46 e Unusual results 46 Nr What you should know about blood pressure L Systolic and diastolic blood pressures 47 2 Why you have to measure differentparameters 47 3 Why measure regularly 47 4 What are normal blood pressure levels 48 M intenarce 1 Changing the batteries 48 2 Cleaning and disinfection 49 3 Customer service 49 Appendix 1 What to do in the event of measuring errors and operating errors 50 2 Specifications accessories spareparts 52 3 Explanation of symbols 54 4 Metrologicalinspection 55 5 Warranty 56 Productinformation Notes on use Productinformation These instructions are designed to help the user operate the digital visomat handy CL blood pressure monitor safely and efficiently The monitor must be used according to the procedures contained in th2. Abridgedinstructions on measurement Please read the detailed Instructions for Use before measuring for the first time from page 38 onwards 1 Insert batteries Alcaline batteries LR 6 2 Bare your left wrist remove any watch or jewellery Place the device round the wrist The distance between the top edge of the cuff and the palm should be approx 1 cm Fig 1 Close the cuff Keep the device at heart level Fig 2 Keep your arm Fit the cuff still and do not talk Abridgedinstructions on measuremern 3 4 5 Inflate the cuff Press the Start Stop button The device conducts a performance test and allthe display elements light up Inflation ofthe cuff is automatic up to approx 190 mmHg If cuff pressure is too low the device automatically increases the pressure in increments of approx 40 mmHg Blood pressure measuemen After inflation the air is let out automatically the falling cuff pressure is displayed and the symbol flashes and a beep sounds Automatic deflation of the cuff indicates the end of measurement The systolic and diastolic blood pressure readings will appear in the display together with your pulse rate Switch off the device Press Start Stop button The figures measured are saved automatically O peration of thedevice 1 2 Seting up the device Place the enclosed batteries in the device if they have not already been inserted see page 48 Changing batteries Fitting the
3. defects we give a warranty on the following terms 1 During the term of the warranty of 3 years as of the date of purchase we agree to remedy such defects at our discretion and at our expense by repair after the product has been returned to our factory or in the form of a replacement by a non defective device 2 The warranty does not cover normal use of wearing parts or any damage which arises as a result of non observance of the Instructions for Use improper handling e g unsuitable power sources breakage leaking batteries and or dismantling of the device by the purchaser In addition the warranty does not cover compensation claims filed with us 3 Warranty claims can only be filed during the term of the warranty by presenting the receipt In the event of a warranty claim the device must be returned to the following address together with the receipt and description of complaint UEBE Medical GmbH Service Center Zum Schlag 18 97877 Wertheim Germany 4 The purchaser s contractual defect rights vis a vis the seller in accordance with 437 of the German Civil Code are not restricted by the warranty Important Inthe exert of awarranty clam please always include the receipt Appendix UEBE REF 21045 visomat und UEBE sind international geschutzte Warenzeichen der UEBE Medical GmbH Zum Ottersberg 9 97877 Wertheim Germany Phone 49 93 42 92 40 40 Fax 49 93 42 92 40 80 E Mail info uebe com Inte
4. mmHg sec Bateries battery type 2 x 1 5 V Micro AAA LR 03 cells Service life More than 600 measurements in 2 years Battery indicator 02 symbol means change the batteries automatic shutdown approx 3 minutes after the end of measurement O perating conditions Ambient temperature 10 40 C Rel humidity up to 85 Storage ad transport conditions Ambient temperature 5 to 50 C Rel humidity up to 85 Subject to technical change without notice Accessories Spare part You can obtain the following genuine spare parts and accessories from specialist dealers Preformed cuff Type H4 for arm circumference 12 5 21 5 cm Art no 2104501 Important To preventin corr ect measurements the device may only be used with gen uine type H4 cuff s Appendix 3 Explanation ofsymbds This blood pressure monitor conforms to Council Directive 93 42 EEC of 14 J une 1993 on Medical Devices and bears the mark CE 0123 TUV SUD Product Service Devices with CE marks are quality controlledin accordance with this Directive and provide a high level Degree of protection against electric shock Type BF A Observe Instructions for Use X Batteries and appliances mustnotbe disposed of with domestic waste but should be handed in at the appropriate collection and disposal points The requirements of the following standards are met EN 1060 1 1995 Non invasive sphygmomanometers General Requirements EN
5. 1060 3 1997 A1 2005 Non invasive sphygmomanometers Additional Requirements on electro mechanical blood pressure measuring devices EN 1060 4 2004 Non invasive sphygmomanometers Test procedure for establishing accuracy IEC 601 1 1998 A1 1991 A2 1995 1 Medical electrical devices 2 General commitment to safety IEC 60601 1 2 2001 A1 2004 Medical electric devices Electromagnetic compatibility This product conforms to Council Directive 93 42 EEC of 14 J une 1993 on Medical Devices Manufacturer UEBE Medical GmbH Zum Ottersberg 9 97877 Wertheim Germany 4 Metrdogicalinspedion previously calibration Generally a metrological inspection is to be recommended at intervals of 2 years Professional users in Germany however are under obligation in accordance with the Medical Devices Operator Ordinance The inspection can be performed either by UEBE Medcial GmbH an authority responsible for metrology or authorised maintenance service centres Competent authorities and authorised maintenance service centres can obtain a Test Procedure for M etrological Inspections from the manufacturer on request Thereto please note your national guidelines Appendix Important No hangs maybemade to this device withoutthe manufacturer s perm sion e g the device must notbe opened except tochange the batterie 5 Warranty The device was manufactured and tested with the utmost care If it should nevertheless have
6. ant to keep your arm still and refrain from talking If the cuff is lower or higher than heart level the measured value will tend to be higher or lower as the case may be Correct measurements can only be obtained if the cuffis atheartlevel If the wristis too high or too low it willlead to false results Operation of thedevice 4 Inflating the aff Switch on the device by pressing the Start Stop button The entire display lights up segment test In this way you can check to make sure that all the display elements are working properly Fig 1 The automatically controlled inflation process Fig 2 starts after the monitor has calibrated itself against the ambient air pressure and stops at approx 190 mmHg If that cuff pressure is not sufficient for measuring blood pressure levels the device automatically increases cuff pressure in increments of approx 40 mmHg until sufficient pressure has been reached The inflation and measuring process can be discontinued at any time by pressing the Start Stop button To control the inflation processed manually keep the Start S top button pressed as soon as inflation has started and release it again as soon as cuff pressure has reached 40 mmHg above the maximum systolic pressure to be expected If cuff pressure has exceeded approx 190 mmHg inflation stops as soon as you let go of the button The pressure can be increased up to approx 280 mmHg Pleasenote Thedevice may only be infl
7. ated when is attached tothe wist Operation of thedevice 5 Messuring blood pressur As soon as the necessary cuff pressure has been reached the pump switches off and the air is letout automatically The falling cuff pressure appears on the display After a short while the symbol flashes and a beep sounds at the same rate as your pulse At the end of measurement air is let out of the cuff automatically The blood pressure levels measured and the pulse reading appear on the display The systole diastole and pulse levels are saved automatically when the device is Switched off 6 Irregular pulse wave If the irregular pulse wave symbol flashes after a measurement the monitor has registered an irregular pulse during the measurement This can be set off by an irregular heartbeat arrhythmia disturbances caused by movement talking or even breathing in deeply Essentially it involves the detection of an eventwhich can unfavourably influence the meas urement results Measurementres ults accompanied by flashing heart symbol displays should therefore be viewed as critical and repeated under more favourable conditions Constant repetition of measurements can bring about congestion and thus le ad to incorrect results Betw een measurements take a break of atleast 3 5 minutes O peration of thedevice 7 Memory recal The device has a memory which makes it possible to display the last 30 blood pressure levels and pulse values
8. ble for monitoring the frequency of cardiac pacemakers Pregnancy Blood pressure levels can be different as a result of pregnancy Only perform blood pressure self monitoring after consulting your doctor Medicines Never use this device without consulting your doctor first if you are undergoing dialysis treatment or taking anti coagulant anti platelet medicines or steroids The use of a blood pressure monitor under such conditions can cause internal bleeding possibly causing haematomas Intravenous supply systems Medical supply systems e g infusions may temporarily discontinue supply if the cuff is constricted Unusual results Any measurement is largely dependenton the circumstances during the measuring procedure Before measurement people often fail to take time to calm their circulation adequately use incorrect cuff sizes they talk or move about during measurement See also the table of measuring errors and operating errors on page 50 Check the situation yourself if necessary Have you met all the conditions Take time for measurement you are monitoring your health S elf measurement does not cons titute treatment Never change of your o wn accord the dose of medicines prescribed by your doctor What you should know about blood pressure 1 2 3 4 Systdic and diastolic blood pressures The cardiovascular system has the important function of supplying all the organs and tissues in the body with sufficien
9. blood pressure twice a day in the morning after getting up and in the evening when you have relaxed after work Blood pressure should be measured when you are seated For measurement sitdown at your dining table never at a low coffee table in as relaxed and upright a posture as possible support the arm and back and do not cross your legs Keep your wrist at heart level Do not bend your wrist The most reliable way of obtaining accurate measurements is to take off your watch or jewellery and perform measurement on your bare wrist During measurement the arm with the cuff must remain still in order to prevent interfering pulses Do not talk during meas urement Between successive measurements always take a break of about 3 5 minutes in order to prevent incorrect measurements 2 Other points tonote Wrist circumference The cuff is designed for a wristcircumference of 12 5 21 5 cm Cardiac arrhythmia Irregular pulse waves If you suffer from cardiac arrhythmia Therefore c onsult your doctor before measuring your blood pressure The monitor is also equipped with a pulse unrest detection facility This indicates to users the irregular pulse waves signals during a measurement These can be caused by an irregular heartbeat or unrest and disruptive movements during the measurement In each case clarify all possible instances of an irregular heartbeat with your doctor Frequency of cardiac pacemakers The display of pulse rate is notsuita
10. ce starts to build up pressure automatically Within a very short space of time the device records the small oscillations within the cuff which occur owing to expansion and contraction of the arteries in the arm pulsation The automatic pressure build up usually stops at approx 190mmHdg If the cuff pressure is too low the device automatically increases the pressure in increments of 40mmHg During the deflation the cuff detects pulse waves which are transfused to the pressure transducer in the device chassis Out of the amplitude of each pressure wave the values of Systole and Diastole will be calculated and displayed From the temporally space between the pulse waves the pulse frequency will be calculated and displayed The monitor offers an additional display for identifying irregular pulses This can be an indication of an irregular heartbeat arrhythmia but also of unrest during the measurement Irregular pulse waves A memory stores the last 30 results for the purposes of comparison Device description Device description 1 2 3 4 5 Display for systole diastole pulse and control readings Start Stop button Memory button memory recall button Battery compartment Cuff Check display symbds No 3C gt m N N Memory data No Of measurement Average No of stored data Device measuring Irregular pulse waves Battery exchange SYS Systle DIA Diastole PUL Pulse rate Inflation Deflation
11. cuff Bare your left wrist remove any watch or jewellery Place the device round the wrist The distance between the top edge of the cuff and the palm should be approx 1 cm Left handed persons can place the cuff round their right arm The instructions for use apply by analogy Now pull the free end of the cuff tight and place itover the velcro strip firmly Owing to its optimised shape the cuff sits tightly in order to prevent any measuring errors Im portant Never use the de vice above a critic al part of the body e g wound intr avascular port etc 3 Positioning the device correcty 3 measuring positions are possible 1 Place the left arm on a dining table and place it at an angle in such a way that the wrist is exactly at heart level For that you could support your arm with a cushion for example but avoid a bend of the wrist 2 If measurement is not being performed ata table the following position can be used press the Start Stop button and place the left arm loosely against the body in such a way that the cuff of the device is at heart level To assistand relieve the left arm you can use the right arm as a support Keep both arms still until measurement has been completed 3 Measuring in the lying position Lie down on your back Place the device round your wrist and keep it at heart level supported by a cushion for example To relax before measurement take a deep breath 5 or 6 times During measurement it is import
12. ese instructions and for no other purpose Read through the instructions carefully and familiarise yourself particularly with the section entitled Basic rules for blood pressure measurement Nots onuse The visomat handy CL is a digital automatic monitor for measuring blood pressure at the wrist Itis based on the non invasive analysis of the systolic and diastolic blood pressures at the arm and the measurement of adults pulse rates i e those of people 15 years of age and over If the monitor is used on younger patients the readings should be compared with doctors measurements Please call our Service phone line for more information Do not uncer anycircumstances use the monitor on bakies infants The product is recommended to patients with unstable blood pressure or known hypertension for home use and therapy Support There may be a flaw in the accuracy of the measurement if absolute quiet is not observed while the measurement is being taken or the conditions stated are outside those parameters laid down in the specifications See technical data The cuff fits at a wrist circumference of 12 5 to 21 5 centimetres The device covers pressures up to 300 mmHg and a pulse rate of 40 to 160 beats per minute Method of measurenert This product uses the oscillometric method for measuring blood pressure and pulse rate The cover is placed round the arm as shown on the diagram on the cuff When the Start S top button is pressed the devi
13. measured and to indicate the mean average If you press the Memory button the mean value will appear provided 2 measurements have already been saved The mean is indicated by A and the number of results saved Pressing again calls up the last value measured Pressing again displays the previous measurementas the case may be In this way you can call up all 30 measurements backwards If more than 30 measurements have been saved the oldest measurement no 30 is deleted in order to record the latest measurement no 1 If the button is pressed again the mean of all the measurements appears Record the figures saved in yourblood pressure pass Overa lengthy period this will provide you with a better pictur e of you rblood pressure situ ation which you m ay wish to discuss with your do ctor 8 Ddeting the nemor To delete individual measurements press the Memory button a number of times to call up the measurement required press again and keep the button pressed for 8 10 seconds The figures will flash 4times then the measurement is disappeared To delete the entire memory call up the mean press the Memory button again and keep it pressed until the mean has disappeared 8 10 sec 1 Basic rulesfor blood pressuranessuremen Measurement must be performed when you are at rest Blood pressure is increased by walking and climbing stairs Wait at least 5 10 minutes until your circulation has calmed down Check your
14. operly Talking during measurement No pressure is being built up in the system Deflation rate too high or too low A faulthas been detected Inflation pressure above 300 mmHg Battery error Cause Irregular heartbeat disruptive movements shaking wobbling objects breathing in deeply etc No batteries inserted Batteries not inserted properly Batteries empty Batteries empty Arm or body movement during measure ment Wrist position too high or too low Cuff not sitting properly Cuff not fitted properly Cardiac arrhythmia during measurement Was the necessary rest observed before measure ment Batteries empty Renedy Repeat measurement after 3 5 minutes Do not move your arm and do nottalk If the error occurs again contact customer Service Repeat measurement and if the error occurs again call the service telephone number If the error occurs again call the service telephone number Repeat measurement after 3 5 minutes Do not move your arm and do not talk Repeat measurement after 3 5 minutes Check batteries Renedy Repeat measurement after 3 5 minutes rest Possible factors depending on the severity of the arrhythmia affecting the measurement results should be discussed with your doctor Check batteries and replace if necessary Check batteries and replace if necessary Repeat measurement after 3 5 minutes Do not move your arm and do not talk Repeat measurement after 3 5 minutes with yo
15. rnet www uebe com Technische Anderungen vorbehalten Copyright UEBE Medical GmbH EBE Germany
16. sure Threshold High pressure Systolic pressure 119 Systolic pressure 120 139 Systolic pressure 14 and or Diastolic pressure 79 Diastolic pressure 80 89 Diastolic pressure 90 xk 1 mmHg millimetres of hydrargyrum mercury It is sufficient if one of the figures is too high C hanging batteries Open the battery compartment Remove the cover of the battery compartment on the side of the device Insert batteries Take the old batteries out of the device and insert the new ones Make sure the polarity is correct there is a mark inside the battery compartment The easiest way of inserting the batteries is to push them into the battery compartmentwhile pressing their negative flat terminal against the spring Close the battery compartment Close the battery compartment by replacing the cover Please note Change the batteries if the battery symbol on the display appears after the display segments have been tested if the display fails to lightup despite your having pressed the Start button Always change both batteries Only use branded batteries of the quality specified see Specifications If the device is going to be out of use for any lengthy period please remove the batteries This prevents leakage Any battery can leak Caution Do notuse rechargeable ba tte ries x Batteries and appliances should not be disposed of with domestic waste but should be handed in at appropria
17. t blood and removing metabolic products The heart contracts and relaxes ata regular rate of about 60 80 times a minute The pres sure of the flowing blood on the arterial walls which arises when the heart contracts is termed systolic The pressure in the ensuing relaxation phase when the heart is refilled with blood is termed diastolic When you perform daily monitoring you measure both figures Why you have io meas re different param ers Our blood pressure responds to external and internal influences like a sensitive measuring instrument It can be affected by even slight changes That makes it easier to understand why figures measured at the doctor s or pharmacist s are often higher than those you measure at home in your accus tomed environment Changes in weather changes in climate physical work and emotional stress can also have an effect Why me ure blood pressureregularly The time of day also has an influence on the level of blood pressure During the day the figures are usually higher than during periods of rest at night For this reason one off measurements and irregular measurements will tell you little about your actual blood pressure Reliable assessment is only possible if individual measurements are taken regularly Discuss the results with your doctor Wha arenormalbloodpressurelevds The World Health Organization WHO has compiled the following overview for assessing blood pressure levels Mantenarte Normal pres
18. te collection 2 and disposal points Clearing anddisinfectim Only clean the device with a soft slightly moistened cloth and a small amount of detergent Stains on the cuff can be removed carefully using a moist cloth and soap and water If you have to disinfect the device we recommend using Descosept AF Dr Schumacher GmbH Melsungen It can be used for fast wipe down and spray disinfection The cuff m ustnot be wa shed or dry cleaned 3 Customerservice The device may only be repaired by the manufacturer or an authorised service centre Please contact UEBE Medical GmbH Zum Ottersberg 9 97877 Wertheim Germany Tel Nr Fax Nr E mail Internet 49 0 9342 924040 49 0 9342 924080 info uebe com www uebe com What to do in the event of measuring arors or operating arors People suffering from cardiac arrhythmia vascular constrictions arteriosclerosis in the extremities and diabetics should consult their doctor before performing blood pressure self monitoring because in such cases the blood pressure levels may be different Mantenarte Appendix E rror ERR 1 Measuring error ERR 2 Inflation error ERR 3 Deflation error ERR 3 Erra v No readings in the dis play fields Battery symbol appears after segmenttest Incorrect measured values Measurements too high Cuff is not being inflated Cause Arm or body movement during measurement The cuff is not sitting pr
19. ur wrist at heart level Check wrist circumference 12 5 21 5 cm Repeat measurement after 5 minutes Repeat measurement after 5 minutes Repeat measurement with at least 5 minutes relaxation before the next measurement Check batteries and replace if necessary Appendix 2 Specifications accesspries spare parts Type ofdevice visomat handy CL automatic digital device with electric pump for blood pressure monitoring on the wrist Setial number In the batterie compartment is a serial number SN which provides clear identification of the device Device dimensions ca B 65 mm x L 66 mm x H 31 mm Weight 110 g not including batteries Measuring system Oscillometric determination of systole diastole and pulse Refeeenceprocedire of dinical trial Auscultatory measurement Display LCD display liquid crystal display Memory 30 measurements Saved automatically and average value Pressuredisplay range 0 300 mmHg Measuring rarge Systolic 50 250 mmHg Diastolic 40 180 mmHg Pulse measurement 40 160 beats min Limits of enor of pressuredisplay Blood pressure monitoring conforms to EN 1060 Part 3 Pressure measurement 3 mmHg Pulse measurement 5 Cuff Doubled preformed cuff Type H4 Defation valve electronic control valve Inflation pressure approx 190 mmHg Additional inflation in increments of 40 mmHg Defation rate On average 5 5
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