User manual
Contents
1. 10 Cardioman is equipped with a battery and other components affecting the environment Please dispose it in accordance with legal regulations 15 Technical data l Technical data Cardioman is strictly oriented on the limits for the interference of pacemakers given in the German draft standard DIN VDE 0848 3 1 Safety in electric magnetic and electromagnetic fields part 3 1 Protection of persons with active implantable medical devices in the frequency range of 0 Hz to 300 GHz The limit curve of page 17 does include pacemakers of categories 0 and 1 as defined in the mentioned draft standard It does not include the rare pacemakers of category 2 For that devices the limits can be below the warning curve at some points Frequency range 0 Hz bis 3 3 GHz Signals acoustic and visual warning Dimensions hxwxd 77 x 68 x 20 mm Weight 88 g Li ion battery 1000 mAh 3 7 V Temperature range 5 C 50 C Wall power supply 5V 0 8 A included in delivery Calibration interval We recommend a calibration after 3 years 16 T echnical data Response curve The limits of the German draft standard DIN VDE 0848 3 1 have been defined in that way that a malfunctioning of a pacemaker can be excluded with field strengths below the limits Extensive measurements with a large number of pacemakers have been performed to prepare the standardization process The limits strongly depend on the frequency of th2. electric magnetic or electromagnetic fields The introduction of novel radio technologies like cell phones WLAN etc the concentration further increases Several directives and standards include limits of field strengths for devices machines and facilities Due to these regulations most devices machines and facilities are totally safe for pacemakers and ICDs However some devices do not allow for a full shielding of the fields or even emit fields as an integrated part of their function e g broadcasting stations Moreover devices can have a defect leading to higher emission than in normal operation Examples of sources that can influence the function of a pacemaker or ICD are strong magnets motors generators current transformers microwave ovens induction heaters high voltage power lines transmitters for radio TV telecommunication and radar magnetic resonance scanners or anti theft devices Cardioman is used to find such exposures and protects you with more safety 10 E xplanations Where should you wear Cardioman Since the influence of relevant sources of interference depends on their distance to the pacemaker or ICD you should bear Cardioman very close to your pacemaker or ICD e g in the breast pocket of your shirt or blouse To probe special devices you can also use the warning device in your sprawled out hand Remark Please take into account that magnetisable objects like a ball pen in y
3. D is shining you are beyond the limits In that case the acoustic beep calls for further attention The meaning of the warning curve itself is explained together with Cardioman s response curve on page 17 The abbreviation LED stands for light emitting diode j Battery symbol Battery charge Whenever this signal is shining you should recharge the battery within the next 3 to 5 hours Please do only use the wall power supply included In delivery see section Recharging the battery U Plug symbol Recharging active signal This LED shines green during the recharging process It expires as soon as the battery is charged to a capacity of 75 A complete recharging process takes about 3 hours independent of the shining of the LED 1 O i peration Vik Antenna and house symbol Indication of far or close sources of interferences fal The antenna and the house symbols indicate if a mea sured source is rather far H shining or close shining This feature is explained in more detail in section Dependence on the distance starting on page 11 LCD Display Field strength The currently measured field strength is displayed on the LCD display on the front side The numbers do not describe the physical value of the field strength but a relative value coding the distance to the limits of the warning curve The reason for this is that the critical field strengths have different values for different electromag
4. battery you have to stick in the cable of the wall power supply included in delivery into the plug socket on the right side of Cardioman During the recharging process the signal l is shining When the LED expires the battery is charged to a capacity of 75 The complete recharging of a fully discharged battery takes about 3 hours o Operation If the battery is completely charged you can use Cardioman for a period of about 1 5 days You should not recharge a battery if it is almost completely charged Remarks gt Please do not use other wall power supplies than that one included in delivery gt You can recharge the battery within a temperature range between 10 C and 35 C gt The wall power supply can get warm during a longer recharging process That is normal and safe The displays at a glance The following figure shows the symbols at the face side of Cardioman After that we explain the single elements Indication of far field Display of the Recharging sources of interference degree of exposure active signal h M P po au K UK K K K K UK 4 Indication of close Battery capacity sources of Interference display U Operation a p Meaning of the displays on the face side LED line Display of the degree of exposure These LEDs shine if you get close to a dangerous field strength The number of shining LEDs increases if the field strength gets closer to the warning curve Once the third LE
5. e interfering field The warning curve of Cardioman is defined with an additional safety reserve with regards to the draft standard s limits The following diagram shows the course of the limits of the standard and the warning curve of Cardioman You can see Even 1f the warning curve is exceeded there is no immediate danger You can unexcited leave the source of interference 17 ugulorpie Jo IANI JUIL A1n9 IOMOT s pono poysep Jejodrun pue pijos e odiq 10 8h80 AGA NIG JO 294m9 pur Amo Joddy ZHD ZHY 00 104 W A ulB5u ns pjoly 000 000 000 01 000 000 00l 000 000 000 0L OOL L L OL 00L 000 L 000 01 000 001 000 000 ZH ul AScu nb 1J 000 000 000 l 000 000 0 000 001 000 OL OL 00L ZH 008 ZH 0 JO W V u1 B5u ns pjay 18 Marking Marking The following label is attached on the backside of Cardioman SN SMW 01085 xxx C Li lon 3 7 V MRC Systems GmbH Made in Germany wa The CE mark documents that Cardioman fulfils the relevant European directives EMC low voltage The crossed waste basket states that MRC is connected to the German waste management system of electronic devices Please do not through away Cardioman to the domestic waste Please bring it to an appropriate sorting station instead 19 Vendor Vendor MRE MRC Systems GmbH Medizintechnische Systeme Hans Bun
6. e are also sources of interference with both kinds of fields In this case both signals antenna and house are shining 12 M i aintenance Maintenance Your Cardioman has been produced in accordance to highest standards In order to maintain the proper function you should keep the following remarks in mind gt Do not expose your Cardioman to direct sunlight heat wetness and dust Do not drop the device and avoid shocks and strong vibrations gt Clean Cardioman only with a soft and dry cloth Do not use wet cloths or aggressive cleaning agents like petrol or thinner gt The LCD display is a sensitive component Please do not put excessive pressure on it gt Should your Cardioman require maintenance please contact the salesman you bought it from 13 Safety EE Safety remarks 1 2 3 4 5 6 Cardioman can not be used to detect danger due to electric shocks or malfunctions of pacemakers or ICDs due to vibrations Cardioman can only measure fields that are already there If a device is switched on a sudden danger can occur that can not be recognized before the switch on The housing is sensitive to splash water Please take care that Cardioman does not get wet The acceptable temperature range is between 5 C and 50 C Please take into account that the measurements can be affected by lower temperatures If Cardioman was accidentally exposed to lower temperatures leap
7. netic frequencies At a value of 100 the warning curve is exceeded The largest possible value is 200 At this value the limits of our referenced standard are reached The higher the value the closer you are to the limits Due to the safety reserve between the warning curve and the limits of the standard even values of 200 do not mean danger yet O peration Cardioman measures in all relevant frequency ranges It always displays the value of that frequency range where the field strengths get closest to the warning curve Normally the display shows very low values e g 004 since you will be in safe areas most of the time But the display reacts earlier than the display of the degree of exposure LED line described above Thus you can even recognize harmless field strengths e g to rate the characteristics of household appliances Acoustic signals If the measured field strengths exceed the warning curve a beep occurs in addition to the visual signals The velocity of the beep sequence increases with increasing field strength This acoustic warning allows you to have Cardioman always with you without the necessity to continuously watch the displays Remark If you switch on Cardioman you will hear a beep But this is not connected to any danger E xplanations Explanations Where do dangerous field strengths occur In today s industrial world we are almost every time surrounded by sources of
8. our breast pocket can distort the measurement That is why we recommend not to store metallic objects close to Cardioman Dependence on the distance The range of electromagnetic fields differs for different sources A good example are broadcast stations Whereas long and medium wave stations can be received far away from the German borders this is not possible with ultrashort wave UKW stations These stations transmit different frequencies And the range of electromagnetic fields depends on the frequency Broadcast stations have a very large coverage compared to household appliances or wireless phones For many other devices the dangerous field strengths are even limited to just a few centimetres 11 Expianation In the case of short range fields it can happen that Cardioman does not warn you as long as it has a certain distance from a device but suddenly calls your attention when the distance is decreased That is why you should preferably wear Cardioman close to your pacemaker or ICD The antenna and the house symbols indicate whether the warning device measures a far range W shining or a short range field f shining In the case of far range fields you can move over a large distance without a change of the warning signal In the case of short range fields on the other hand a small change of distance can lead to an immediate change of the degree of exposure and therefore of the intensity of the warning signal Ther
9. s of the displayed values can occur However the warning function is fully maintained under such conditions After a few minutes the display should behave normal again The display is sensitive to finger contact Please do not touch the display during measurements Please consider that Cardioman is a sensitive electronic measurement device Contact to your skin or contact to any devices can provoke field distortions that can lead to wrong values in turn Turns or changes of fingering the device can lead to fluctuations of the measured values Do not be surprised if different persons measure slightly different values in the same environment You might know this effect from your radio You can change the receiving 14 Safety remarks i 7 8 9 quality by touching the antenna We have considered this effect when we defined the warning curve You get a warning signal before your pacemaker or ICD is exposed to critical field strengths Strong magnetic fields can lead to a mismeasurement if they are brought very close to the warning device In these cases the measured values can change without noticeable reason Please do not be bemused Once Cardioman has detected a magnet you should avoid this magnet even if the warning signal decreases or stops Please do not use other wall power supplies to recharge the battery than the one included in delivery You must not open Cardioman Any change of the device is not allowed
10. te StraBe 10 D 69123 Heidelberg Germany Web www cardioman de E mail info cardioman de Phone 49 6221 13 80 345 MRC Systems GmbH October 2014 Subject to change without prior notice MRC 1014 6 e 20
11. tic fields Cardioman is equipped with modern components for optimal detection of different fields It warns you by visual and acoustic signals against fields that can lead to malfunctions of your pacemaker or ICD The sensitivity of the detectors is adjusted in that way that the warning occurs before critical field strengths are reached Thus you can recognize in time which areas or objects you should avoid This manual explains the operation and the interface of Cardioman Moreover we give you some tips for maintenance of the warning device as well as some safety information Cardioman enhances your safety in everyday situations Having the device at your side you can act as relaxed and mobile as you want to 4 eee O peration Operation On off switch To activate the warning function you have to switch on Cardioman If you do not have it in use you can switch off Cardioman in order to conserve power 0 The on off switch is placed on the right side The device is switched on in position 1 In that case you can 1 see the numbers shining in the display Recharging the battery Cardioman is equipped with a modern Li Ion battery The symbol j shines if the battery charge ts too low Once it starts shining you can use Cardioman for a period of about 3 5 hours By the end of this period you must recharge the battery It is no problem if the battery is occasionally fully discharged For recharging the
12. w Cardio jan The new warning device for pacemaker and ICD patients Card io fha n User manual ww wsa Front view Face side view Indication of far field Display of the Recharging sources of interference degree of exposure active signal lt Y P _ _ au K UK K K K K 8 A 4 Indication of close Battery capacity sources of interference display Z wc Contents TREC OT ce uyu aa E eee ec eae 4 ODETE ener er nr sa wa ce 5 ONOI SWII6l uuu uz uma sum usu nasa mataas 5 Recharging the battery y la l a era 5 Thedisplays ata glang u u uuu die Su uuu asas 6 Meaning of the displays on the face side 7 LCD Display Field strength 8 ANCOUSTIC Sipha ls uru uma Q a anash Eae 9 Explanada ONS yy unu uum ee ee i1s 10 Where do dangerous field strengths occur 10 Where should you wear Cardioman 11 Dependence on the distance 11 Niainieninceu unu a E usa 13 SalelyelmarkSuru pusa Qua sa a xia ako eereeae eins 14 Technicalidatau au au eres ieee nies 16 RESPONSE myosurus au susunan sasiausu as 17 Ie IAI is uu yanu m Sua Sau aerate 19 Nendo negatie a r O qhsakssulacayaqayskas2 20 TERE Introduction Congratulations for buying Cardioman the device for pacemaker and ICD patients that warns against electric magnetic and electromagne
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