User Manual for the CardiAid AED
Contents
1. CardiAid immediately starts a self test when switched on During self test all indication and warning LEDs light up When self test is completed indication symbols show the status of the device Observe the status indicators before continuing to use CardiAid Green OK Symbol flashing indicates that the device is ready to use The combination of the status indicator lights have different meanings See Section 7 Troubleshooting for further details Caution N If the green OK Symbol is not flashing the device is not ready to use Immediately contact Cardia International or an authorized service provider Caution N If any of the red Battery Symbol or Repair Symbol is flashing immediately contact Cardia International or an authorized service provider See Section 7 Troubleshooting for further details Caution N If the red Battery Symbol is flashing indicating a low battery immediately contact Cardia International or an authorized service provider The battery should be replaced after max 3 years or when the device gives low battery warning Warning N Red Repair Symbol flashing together with the green OK Symbol indicates a warning that the electrode is not plugged rather than a problem affecting the operation of the device If you observe this situation plug the electrode to the device Caution N If one or more of the instruction lights does not light during self test the light diodes may b2. uBBlu01198 3 A 32u el duuo9 A8 4S9 10909 33 s s3 Alunului JUBWUOJIAUS ue yans ul payesado SI 4 Jey ans yeui p n0us piVIDJe9 4O Jasn 10 Jawoysno ay mojaq paisloads 1u uuuoJIAu8 311 uBPuu01198 34 u u0l eJ do 104 p pu lul s piy p1eg Ajunwiut 3 uBeuio4323 3 uoneie 33 p 1i31n 3ejnueui pue s ui j pinp 12 Technical Information 2 L 10909 NJ WIM 998 u uonewoju IWI Q HSI19N3 AD 12 Technical Information Guidelines and manufacturer declaration Electromagnetic immunity CardiAid is intended for operation in the electromagnetic environment specified below The customer or user of CardiAid should make sure that it is operated in such an environment Immunity tests IEC 60601 test level Compliance level Electromagnetic environment Conducted HF noise in 3 Vrms acc with IEC 61000 4 6 150 kHz 80 MHz 3 Vrms Radiated HF noise in acc 3 V m 3 V m with IEC 61000 4 3 80 MHz 2 5 GHz Portable and mobile wireless devices should not be used at distance from CardiAid including its power line cables smaller than the recommended safety distance This is calculated according to the equation for the relevant transmission frequency Recommended safety distance d 1 17 m V VP for 150 kHz 80 MHz d 1 17 m V VP for 80 MHz 800 MHz d 2 33 m V VP for 800 MHz 2 5 GHz P being the power rating of the transmitter expressed in W ac
3. 8 years gt 25kg with standard adult electrodes and patients 1 to 8 years old lt 25kg with special paediatric electrodes Caution N If you suspect that a person is having sudden cardiac arrest check for signs of life i e consciousness and breathing before using the device CardiAid should be used and defibrillation can be delivered only when the person is unconscious and the breathing is absent or not normal Caution N Check CardiAid and its accessories for visual damage before using the device If you observe damage on the device or its accessories do not use it Otherwise there may be functional errors resulting in the injury of both the patient and the user Caution Do not use the device if you observe differences in the procedures from the ones described in the user manual In this case immediately contact Cardia International or a Cardia International authorized service provider Caution CardiAid can be used only after self test is completed successfully and any damage or misuse is not detected Caution N Check periodically whether the device and its accessories are ready for use See Section 6 2 Function Check for further details Caution N Use the device only in dry and non conductive environments Using CardiAid and delivering defibrillation on a wet or conductive surface or In a humid environment may cause injuries electrocution burning etc of the patient user and or the by standers G ENGLIS
4. Cardia International or a Cardia International authorized service provider Do not attempt to unscrew the device This invalidates the warranty may cause serious injuries and or irreversible Repair Symbol are lighting continuously during operation or Device is not ready for use damage on the device Failure Messages of CardiAid Cause Action Visual Acoustic CardiAid can be used only in Battery Symbol and OK Battery Is low Battery emergencies Contact Cardia Signal tone in aie Symbol are flashing ene hour can only supply a limited International or an authorized during stand by y number of shocks service provider immediately for battery replacement Battery Symbol and f CardiAid can be used only in eas Battery is low It can only emergencies Contact Cardia OK Symbol are lighting k TA i i I Battery low supply a limited number International or an authorized continuously during I of shocks service provider for battery operation eplacement Battery Symbol and f I Device cannot be sed Contact i Signal tone in Cardia International or an Repair Symbol are Battery is empty I every hour authorized service provider flashing during stand by s mmediately Battery Symbol and 2 Device cannot be used Contact Battery low Battery is empty Cardia International or an authorized service provider immediately OK Symbol and Repair Symbol a
5. S B 2 FURCTIONIGNECK is uz ua a unan 7 Troubleshootinga 2 02 ccc c2ecceereares az emtntassenueneyccawawciacshs 8 Disposalu u cece ecceecseeeeseeeeeessecsneesecsnecsneesseeseseseeeneesneesneeseeeeeens 9 Storage 10 Maintenance 10 1 After Use Manana u u u u u u u uuu uuu ununuunuunsuwususa 10 2 Periodical Malntenance a aaa 11 Package Content cece cee eeeeeseeeeesteesnecsneesteeseesseeenes 12 Technical Information 12 1 Technical SpeChiCatiOns uu u uuu u uyu uuu unususs 122 Pulse FONT eroze a u u uu un asuy 13 Address Information aaa aaa Overview of CardiAid CT0207RS amp CT0207RF CT0207RS 1 Device Cover 2 Socket for Electrode Plug 3 Loudspeaker 4 Emergency Kit Defibrillation Electrodes Protection Bag Indicator Window Indicator Remove clothing from chest and stick on electrodes 9 Indicator Do not touch the patient from now on 10 Indicator Patient may be touched 11 Indicator Ready for Shock only for CT0207RS 12 Shock Button only for CT0207RS 13 Info Button 14 Repair Symbol 15 Battery Symbol 16 OK Symbol m con o amp GD ENGLISH GN ENGLISH Overview of CardiAid CT0207RS amp CT0207RF a CPR Mask b Razor c Scissors d Gloves e Alcohol Pad Overview of CardiAid CT0207RS amp CT0207RF 1 Device Cover
6. You can touch the patient only after hearing the instruction Patient may be touched Basic Life Support 8 After delivering the electroshock CardiAid proceeds to basic life support The _ instruction Patient may be touched Carry on resuscitation alternately make 30 chest compressions and give 2 mouth to mouth breaths is heard Simultaneously the green light and LEDs around the second instruction field in the J middle light which indicates that the patient can be touched from the moment CardiAid also provides metronomic signals to guide the rescuer with the correct rhythm and number for the chest compressions After 30 signal tones verbal instruction Now give 2 mouth to mouth breaths is heard followed by a short silence for rescue breaths Then the user is directed to chest compressions with the verbal instruction Now give 30 times chest compressions This cycle is repeated for 2 minutes according to the latest resuscitation guidelines Caution N If you detect signs of life like consciousness or breathing during resuscitation proceed as indicated in section Signs of Life Present Caution N After basic life support recheck the status of electrodes If necessary press the electrodes firmly on patient s chest to re establish the contact After 2 minutes according to the current resuscitation guidelines a new heart rhythm analysis starts See Section 4 and second instruction field in the mi
7. its accessories in any liquid Liquid ingression may cause serious damage and the device can be unusable 21 G ENGLISH cen ENGLISH 6 Function Test CardiAid performs an extensive self test periodically on stand by status g cover closed Additionally a self test is performed at the start of each operation when cover is opened The result of the self test is indicated with J Battery Symbol i I ss status indicators battery symbol repair symbol and OK symbol In addition Q Repair Symbol to these periodical self tests functions of CardiAid should be checked on a OK Symbol regular basis 6 1 Periods of User Tests Daily Check the status indicator symbols of CardiAid daily If the green OK symbol is flashing in stand by position CardiAid is ready for use If the red Battery Symbol or Repair Symbol is flashing see Section 7 Troubleshooting If the problem persists contact Cardia International or an authorized service provider immediately Semi annual Perform a function check every 6 months See Section 6 2 Function Check for details 6 2 Function Check Perform function check every 6 months as explained below If you observe an error or discrepancy in the values do not use the device and try to solve the problem by yourself by referring to Section 7 Troubleshooting If the problem cannot be solved contact Cardia International or a Cardia International authorized service provider immediate
8. should not be delayed to determine the exact age or weight of the patient 1 5 Contraindications for Use CardiAid should not be used if any of the following signs are present e Consciousness and or responsiveness e Breathing 1 6 Important Points in an Emergency If you suspect that a person is having sudden cardiac arrest keep in mind the following points 1 Keep calm and proceed rapidly 2 Check consciousness and breathing e Check the victim for a response Gently shake the shoulders and ask loudly Are you all right e Check for normal breathing Caution N CardiAid should be used and defibrillation can be delivered only when the person is unconscious and the breathing is absent or not normal 3 Phone emergency services and provide the following information e Your name e Your current location e Number of patients e Type of emergency suspicion of sudden cardiac arrest e Presence of a defibrillator PAD AED Attention iN While starting resuscitation make sure the emergency number is called without delay preferably by other people around you 4 Open the cover of CardiAid The device will switch on automatically 5 Follow the instructions exactly See Section 4 Operation for detailed information regarding the verbal instructions Caution N Note that the information in this user manual does not substitute a basic life support training 2 User Manual 2 1 Description of the User Manual Please read
9. CardiAid Automated External Defibrillator User Manual and Introduction to the Device For Models CTO0207RS and CT0207RF CardiAid Public Access Defibrillator User Manual and Introduction to the Device For Models CT0207RS and CT0207RF GO ENGLISH cen ENGLISH Contents Overview of CardiAid CTO207RS amp CT0207RF 1 Introduction to the Device 1 1 Intended Use 1 2 User Ola liRCat ON a u u u u uu u u ul usus u S Susa 1 3 Description of the Functions 1 aaa aaaaaaaa 6 1 4 Indications for Use 1 Contraindicatl ons for US82 u u uuu u uu uu usus upas sss 8 1 6 Important Points in an EMErGeNCy scccccescesestessesseestesteeseeseeseeseeees 8 2 Us r Mantal u uu uuu u u L u u ua on en 9 2 1 Description of the User Manual a a aaasassssssssssss 9 2 2 Labels on the Device and its Accessories 2 3 Salot RUES u L uu L a m m u zu 22 General Hu BS2 us uu u umn errr eee rs Defibrillation Usb u u a E 86U0068S2 au corse cases aunaunsanmarusaymarasatasanmanqipasaasqssaq 2 4 Side Effects 3 Preparing CardiAid for Use l aula A Operation u u u uuu masa eA aaa 0 4 1 Before Using CardiAid 4 2 Providing Reanimation 4 3 After Using CardiAid 4 4 Operation Documentation ceceecseesseessessteesteeseeeseesseeeeesteeeeees BY QNCM Ges ccs La aaa EE 6 Function Test 6 TParioderulsepTesfsu uu u u u
10. CardiAid is switched on by opening the cover and switched off by closing the cover Closing the cover will switch off the device only after the electrodes are disconnected 2 Socket for Electrode Plug Electrodes are connected to CardiAid through this socket Electrodes supplied with the device are already connected to this socket 3 Loudspeaker Audio warnings of the CardiAid are heard through this loudspeaker 4 Emergency Kit Emergency kit includes scissors shaver respiration mask gloves and alcohol pad Emergency kit should be replaced after use 5 Defibrillation Electrodes Electroshock is delivered to the patient through these electrodes Electrodes should be replaced after each use 6 Protection Bag Protection bag is used to store carry and protect the device 7 Indicator Window The status of the device can be observed through this window on the protection bag 8 Indicator Remove clothing from chest and stick on electrodes When this indicator lights you should stick the electrodes on patient s bare chest 9 Indicator Do not touch the patient from now on Patient should not be touched when this indicator is flashing For example During heart rhythm analysis and shock application 10 Indicator Patient may be touched While this indicator is lighting patient may be touched For example During cardiopulmonary resuscitation 11 Indicator Ready for Shock only for CT0207RS This indicator flashes when CardiAid
11. E Caution Packaging material may cause s regulations for disposal of packaging material ectrodes uffocation Keep away from children Refer to local ollowing e CardiAid Emergency kit Containing CPR mask shaver scissors gloves and alcohol pad e CardiAid User Manual e CardiAid Quick Reference Guide The following accessories and spare parts may be ordered separately Description of the Item Model Nr CardiAid Adult Defibrillation Electrodes CR 13A CardiAid Paediatric Defibrillation Electrodes CR 13P CardiAid Emergency Kit CT0207EK CardiAid Protection Bag CT0207P CardiAid Battery Pack CA 4BP CardiAid Trainer AED Training Unit CT0207RT CardiAid Featured Indoor Cabinet CC001W CardiAid Basic Indoor Cabinet with Transparent Cover CC002T CardiAid Basic Indoor Cabinet with Metal Cover CC002M CardiAid Outdoor Cabinet CC001T CardiAid Wallmount CT0207W The information above might be subject to change Please visit www cardiaid com for up to date information on all products and accessories 28 12 Technical Information 12 1 Technical Specifications DEVICE Dimensions x w x h in mm Weight with battery and electrodes Akg Product class according to Medical Product regulation or Regulation No 93 42 EEC a aaaaaaaaasaaa Ilb Operation Temperature limits Humidily Air pressure Transportation Storage Temperature limit
12. E At 80 MHz and 800 MHz higher frequency field is applicable NOTE At 80 MHz and 800 MHz the separation distance for the higher frequency range is applicable NOTE These guidelines may not apply in all situations Electromagnetic transmission is affected by absorption of and reflection from structures objects and people tput power not listed above the recommended separation distance d in metres e P is the maximum output 31 G ENGLISH ux w Ve 8 7 00019 D3 UHA 998 ul s Ju uuu0llAu 8 e1Idsou pue ssaulsng 10J zH09 09 jeaidA s njea aney p nous dul samod y 104 Sp J IUBE Anuanba Ajddns Joy pjaly aaue S G 10 LA u doup 66 lt LN gt spolad GZ 104 1N ul doup 0 LN 0 spoliad q JO yum 33e ul Be joA Ajddns ponad 4 10 y u suoigenyonjy pue suondnu lu VN LA Ul dop 96 lt LN G gt Ww1a HOYs sdo1p 8240A BB1 0A BpOwW UOWWOI AJ Z I YN 8Be1 o0A apow Salas Ay F G 7 00019 931 YM 338 ul s Bins s ul 1ndino indul 104 AJ F p p 00019 93 UM 908 ul WN Saul JaMOd 104 AJ ZF slsinq asiou 311799 JUalsued 1sej 08 4829 18 JO AiIpitunu A18 81 e AB8U 1snu 1 Jerazew NAYUAS YPM D818A03 SI 100 J Y J I1 NIWeJED UNA abieyosip se A 8 F aBeyasip 11e AJ 8 F V 00019 33 p84 A03 Aq 10 81813U03 JO POOM Jo pewu ag p n0us 100 By aBseyasip 1981u03 AJ 9 F aBJeYasip 1981u03 AJ 9 F qs3 Bieu3sip 31e1s0139 3 1u uluoJiAu 31
13. H GN ENGLISH gt P P gt 2 User Manual Caution N Do not attempt to deliver electroshock if defibrillation electrodes are in contact with each other or are not connected to the patient gt Danger Be sure that the electrode cable is not wedged when closing the cover of CardiAid It may UES damage the electrode cables Caution Charging and delivering electroshock may affect the electronic devices nearby Check the function of these devices before using CardiAid Warning Operation of CardiAid can be affected from electrical and magnetic fields Keep CardiAid at least 2 meters away from electrical devices such as cellular phones walkie talkies X ray machines etc Warning Do not immerse CardiAid or its accessories in any liquid Liquid ingression may cause serious damage and the device can be unusable Warning Use only original accessories and spare parts Using incompatible accessories or spare parts can cause irreversible damage to the device and serious injuries Use of non approved accessories and spare parts invalidates the warranty of your device and the manufacturer will not be responsible for any damages caused gt gt Defibrillation Use Caution N Always observe national regional laws and regulations in effect regarding the use of an automated external defibrillator Caution N To prevent injuries of the user the patient and any by stander make sure the patient is not being touched
14. R 13P Paediatric Electrodes should be used if the patient is 1 to 8 years old or weighs less than 25kg Therapy should not be delayed to determine the exact age or weight of the patient gt Caution Never use electrodes which have damage on the package and or on the pads Do not use electrodes after the expiry date written on the electrode package Caution Open the electrode package only in case of an emergency and just before use gt P G ENGLISH 2 gt cen ENGLISH gt P P P User Manual Caution If the patient has an implanted pacemaker do not stick the electrodes on the pacemaker Using the defibrillator on a patient with implanted pacemakers can lead to incorrect analysis of the heart rhythm and to irreversible damage of the myocardium in case the electrodes are placed too close to the pacemaker Caution Do not place the electrode pad on the nipple Caution If there is excessive hair on chest use the razor in the emergency kit of CardiAid present inside the cover of the device to clear the chest before applying electrode pads Caution Remove all clothing from upper body before applying electrode pads Clothes or undergarments with metal parts may cause burns on skin Caution CardiAid defibrillation electrodes are for single use only After using CardiAid immediately contact Cardia International or an authorized service provider for replacement of the electrodes gt gt Caution P
15. SOD vor a s Cardia Interr A S He ide 20 4000 Roskilde De k REF CDOZAEOO Battery Life Label Battery Product Label on battery Electrode Product Label A Sr N sN Serial number of the device Q Do not re use i Date of manufacture an Keep dry E Ponet dapose he doce GZ avi physical impact Defibrillation protected Avoid physical d A type BF patient connection G VOLE PSIA ramage Kp Bluetooth Keep away from fire Cli Consult instructions for use Do not dispose in household waste Dust protected protected against gt K i IP55 water jet ZN Keep away from sunlight l Manufacturer S Do not use if package is damaged A High voltage A Use by period after package opened Replace battery before this date REF Part number Caution Further information in user 7 Use by date manual i Temperature limits LoT Batch code Humidity limits tT Transport and store this side up Atmospheric pressure limits 5 Fragile handle with care N JX J 2 User Manual 2 3 Safety Rules To ensure safety of the user the patient and the bystanders please pay attention to the following safety instructions which are the requirements of Directive 93 42 EEC General Rules Danger To prevent danger of explosion keep CardiAid away from oxygen sources flammable JEAN anaesthesia gases and other flammable substance or gas mixtures Caution N CardiAid can be used for the resuscitation of patients older than
16. TION ANALYSIS Operating mode Semi Automatic One button operation in CTO207RS Full automatic in CTO207RF Wave form Biphasic Current controlled 29 GO ENGLISH cen ENGLISH 12 Technical Information Delivered energy at 50 Q Adult Mode Low energy 170J 15 High energy 270J 15 Low energy 50J 15 High energy 75J 15 oO Maximum patient impedance SHOCK SCQUONCE i uuu unas Cycle duration Analysis and shock preparation With fully charged battery After 15 shocks Max 24 sec After SMOCKS retera en Max 20 sec Cycle duration Switch on analysis and shock preparation aaa With fully charged battery After 15 SOCKS senean n ised ia Rn ia lt 50 sec Constant or escalating programmable factory setting After GSIOCKS ae a E AE EE E E E eee lt 45 sec CPR duration 20 sec adjustable by factory settings ECG ANALYSIS SYSTEM Duration of analysis lt 10 sec Derivation Impedance measurement Movement detection Controlled by electrode contac usss nas Checks the signal quality E Acoustic warning at patient movemen Reaction to i mplanted pacemaker Normal cardiac pacemaker rhythm is not detected as being shockable Asystole threshold lt 0 160 mV Sensitivity VF PVT oo cceecscseccssescsssescssssessscessnsecssesssnsecss
17. age with increasing impedance Because the voltage enters the supplied energy quadratic with increasing resistance applied energy also rises considerably This in turn provides a better treatment for patients with high impedance and has a positive effect on decreasing death rate in this patient group 35 D ENGLISH cen ENGLISH 13 Address Information 36 Headquarters Cardia International A S Hersegade 20 4000 Roskilde Denmark inform cardiainternational com www cardiaid com Cardia International A S Hersegade 20 4000 Roskilde Denmark www cardiaid com
18. al instruction Now give 2 mouth to mouth breaths is heard followed by a short silence for rescue breaths Then the user is directed to chest compressions with the verbal instruction Now make 30 chest compressions This cycle is repeated for 2 minutes according to the latest resuscitation guidelines Info Button By pressing the Info button during basic life support stage duration of use and number of shocks delivered can be heard During this time the timer for basic life support continues in the background Application Documentation CardiAid records ECG and incident data in its internal memory These data may be obtained from the device as a report to be analysed by specialists to define subsequent treatment Self testing CardiAid performs an automatic self test daily monthly and each time the cover is opened i e when the device is switched on The status of the device is indicated with flashing status symbols on the front side of the device GO ENGLISH cen ENGLISH 1 Introduction to the Device 1 4 Indications for Use CardiAid is indicated to be used on victims of sudden cardiac arrest when e The patient is unconscious an unresponsive e The breathing is absent or not normal CardiAid CR 13A Adult Defibrillation Electrodes should be used for patients older than 8 years or weighing more than 25kg CardiAid CR 13P Paediatric Electrodes should be used if the patient is 1 to 8 years old or weighs less than 25kg Therapy
19. ance and manufacturer s declaration electromagnetic emissions Immunity Test IEC 60601 1 Test Level Compliance Level CardiAid Public Access Defibrillator is intended for use in the electromagnetic environment specified below The owner or the user of CardiAid should assure that it is used in such an environment Electromagnetic Environment Guidance conducted RF IEC 61000 4 6 3 Veff 150 kHz to 80 MHz outside ISM bands not applicable for patient instructions according to EN 60601 2 4 Portable and mobile RF communications equipment should be used no closer to any part of the Public Access Defibrillator CardiAid including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter d 4 SORT P W for 80 MHz to 800 MHz For d 7 67 root P W d 7 67 SORT P W for 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 metres m Radiated RF IEC 61000 4 3 10 Veff 150 kHz to 80 MHz inside ISM bands 10 V m 80 MHz to 2 5 GHz not applicable for patient instructions according to EN 60601 2 4 3 V m Field strength 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
20. as indicated in Any an authorized service provider immediately 24 8 Disposal Do not dispose the device to common household waste For detailed information regarding disposal of the product and its accessories visit www cardiaid com For disposal of used electrical and electronic devices refer to special collection system for these type of devices in European Union countries and other European countries The symbol on the product or its packaging indicates that this product cannot be disposed in common household waste Electrical and electronic devices should be delivered to recycling mamam facilities With your contribution to disposal of this product you can help protecting both the environment and its inhabitants Incorrect disposal methods threaten the environment and health of the community Material recycling reduces the use of raw materials You may obtain additional information regarding the recycling of this product from municipal regional disposal facilities or from the dealer you purchased the product Always consult a licensed analyser of electronic worn out components for proper disposal of this device 25 GO ENGLISH cen ENGLISH 9 Storage Always obey maintenance and function test schedule regardless of whether the device is used rarely or stored for long periods Device cannot be used if one of the maintenances is not performed on time Always make sure maintenances and periodical controls are p
21. ay attention to the operating and storage conditions of the device and its accessories which are indicated in technical specifications Caution Keep and store the device and its accessories away from children Electrode cables may cause suffocation 2 4 Side Effects The following adverse side effects may occur when CardiAid is used e Burns on skin e Rashes on skin e Delivering electroshock to a patient who has implanted pacemaker or is connected to other electronic devices can cause damage to these devices e Delivering electroshock to a patient having a non shockable rhythm may cause fibrillation 3 Preparing CardiAid for Use Unpacking the Device Remove CardiAid from its packaging carefully Check whether all parts are present according to Content of Delivery on Section 11 Check all components for any sign of damage Contact your sales representative or Cardia International directly if there are any missing or damaged components Opening the Cover Open the cover of CardiAid Device will switch on automatically G ENGLISH Connecting Electrode Plug CardiAid is delivered with electrodes pre connected to the device Always keep the device in this condition to help save time in an emergency If not connected already connect the electrode plug to the socket on the device Special design of the plug prevents user mistake It can only be connected as required Placing Emergency Kit CardiAid is delivered with an emerg
22. cording to the specifications of the transmitter manufacturer and d the recommended safety distance in m The field strength of stationary wireless transmitters should be less than the compliance level for all frequencies according to an on site investigation Dp Interference can occur in the environment of devices which are marked with the following symbol REMARK 1 At 80 MHz and 800 MHz the higher frequency range applies REMARK 2 These guidelines might not be applicable in all cases The propagation of electromagnetic parameters is influenced by the absorption and reflection of buildings objects and human beings a Field strengths of fixed transmitters such as base stations for mobile portable communication devices cannot be theoretically predicted with absolute certainty In order to evaluate the electromagnetic environment based on fixed HF transmitters an electromagnetic investigation on site should be considered If the measured field strength should exceed the HF compliance level specified above in the intended operating environment of the product the product should be monitored to verify that it functions normally If abnormal function should be observed additional measures might be necessary such as re orienting or re positioning the product b Field strengths should lie under 3 V m over the frequency range 150 kHz to 80 MHz 33 GO ENGLISH cen ENGLISH 12 Technical Information Guid
23. ddle lights Shock Not Advised After heart rhythm analysis if CardiAid detects normal sinus rhythm asystole or another rhythm which is inappropriate for defibrillation the instruction Shock not advised is heard and CardiAid proceeds to Basic Life Support phase 19 GD ENGLISH cen ENGLISH 4 Operation Analysis Result If CardiAid cannot perform a clear heart rhythm analysis due to incorrect electrode connection or inadequate signal level which is a result of touching or moving the patient the warning Movement detected Do not touch the patient from now on is heard CardiAid will attempt another heart rhythm analysis If the analysis is successful device proceeds according to the results as explained in sections Shock Necessary or Shock Not Advised f the second attempt is also unsuccessful the device proceeds to Basic Life Support phase Signs of Life Present If you detect signs of life like consciousness and normal breathing during operation of the device place the patient in recovery position lying on one side Do not remove electrodes CardiAid will continue operating normally Heart rhythm analysis will be performed regularly If the patient loses consciousness again and Shock necessary instruction is heard place the patient on his back again and follow CardiAid s instructions Information Function During operation of CardiAid information about the duration of use and the nu
24. des whether defibrillation is Necessary or not and informs the user accordingly CardiAid continues analysing the heart rhythm until the device is turned off The ECG analysis is continued also during the charging of the device The electroshock is aborted if the device detects a change in the rhythm A change from Shock necessary to Shock not advised is the result of a change in patient s condition and is not a malfunction Attention N CardiAid Is turned off by unplugging the electrodes and closing the cover of the device Closing the cover of the device when electrodes are still plugged in and connected to the patient does not stop the operation Defibrillation If CardiAid detects a rhythm which requires defibrillation Venticular Fibrillation VF or Venticular Tachycardia VT it informs the user and prepares the electroshock In semi automatic model CTO207RS CardiAid instructs the user to press the shock button to deliver the electroshock In the full automatic model CT0207RF the device warns the user and delivers the electroshock automatically The user cannot deliver an electroshock unless the device detects a shockable rhythm and prepares the electroshock CPR Guidance In the basic life support phase CardiAid guides the user according to the latest resuscitation guidelines It provides metronome signals so that the user can perform chest compressions with the correct rhythm and number After 30 signal tones verb
25. e faulty The device may be used in the current incident if there is an emergency Immediately contact Cardia International or an authorized service provider for repair 4 2 Providing Reanimation After opening the cover verbal and visual instructions guide the user through the whole reanimation process In this section you may find details on how to act on each verbal and visual instruction given Caution N Note that the information in this user manual does not substitute a basic life support training 16 4 Operation Caution N The cover of the device should not be closed during operation Preparation of defibrillation 1 Check for breathing and Phone emergency services This instruction may be differentiated to fit the national emergency number in your country These instructions can be deactivated by an authorized service provider verbal instructions are heard immediately after opening the cover of CardiAid The LEDs around the indicator of the first instruction field on the left light While starting resuscitation make sure that the emergency number is called without delay metert by other people around you Check the patient for the following signs of life e Consciousness e Normal breathing CardiAid should be used and defibrillation can be delivered only when the person is unconscious and the breathing is absent or not normal 2 If not breathing normally remove clothing from chest and stick on elect
26. edance is reduced considerably with this pulse form Pulse form shock energy can only be configured by factory Factory setting is as follows 1st Shock Low 2nd Shock Low 3rd and Subsequent Shocks High Delivered Energy High energy adult impulse at 50 Ohm 270 J 15 Low energy adult impulse at 50 Ohm 170 J 15 High energy paediatric impulse at 50 Ohm 75 J 15 Low energy paediatric impulse at 50 Ohm 50 J 15 Current characteristics of high energy adult impulses Functioning Principle for different patient impedances lf the current exceeds the specified value current transmission is interrupted Current continues to flow to eee the patient with inductivity in e connection path However the 5 current falls gradually If the specified current value exceeds 1 Amp current transmission re starts In this way current supplied to the patient rises again This creates a saw tooth pulse Proportion of supplied electrical current integral of current in time between 2nd negative and 1st positive phases is 0 38 on average This value is determined as optimal in clinical studies Impedance Dependence For safety reasons a current of maximum 2000 Volt is used Resulting current as a function of patient impedance is shown in the graph Energy Flow in High Patient Impedance Supplying a fixed current has a determining effect on the energy applied to the patient Ohm s law requires higher volt
27. ency kit placed inside the cover of the device and electrodes placed inside the package in front of the emergency kit Always keep the device in this condition to help save time in an emergency Emergency kit includes a single use razor scissors respiration mask gloves and alcohol pad The items in the emergency kit are for single use only After using CardiAid contact Cardia International or an authorized service provider for replacement Closing the Cover Close the cover of CardiAid carefully The device will switch off automatically Danger Make sure that the electrode cable is not wedged while closing the cover of the device It JEAN may damage the cable Installation Different storage options are available for CardiAid You can choose the product which suits your needs the best e CardiAid Wallmount It provides practical storage for CardiAid AED CardiAid Wallmount also provides storage for spare electrodes if necessary e CardiAid Indoor Cabinets Specially designed for CardiAid they ensure that CardiAid AED is noticeable and easily reachable in case of an emergency while providing its safety e CardiAid Outdoor Cabinet It provides climate protection and high visibility outdoors Installation instructions and necessary parts are included in the packaging of the products cen ENGLISH 4 Operation 4 1 Before Using CardiAid Switching CardiAid On Open the cover of CardiAid Device will switch on automatically Self testing
28. erformed without delay Pay attention to the storage condition requirements of CardiAid see Section 12 Technical Information Excessive ambient temperature can shorten the battery life considerably Do not keep CardiAid under direct sunlight Store CardiAid in dry environment 26 10 Maintenance CardiAid is subject to maintenance periodically and after each use as described below Previously performed maintenances if there is any can be tracked from the maintenance label on the device 2nd Year Maintenance 4th Year Maintenance After use Maintenance Service Provider ID Cs Service Provider ID Cs Datei 20 Datel 20 Casal Periodical Maintenance Label After use Maintenance Label Danger Inspection repair and other maintenance actions can be performed only by Cardia SAY International or a Cardia International authorized service provider Do not attempt to unscrew the device This invalidates the warranty may cause Irreversible damage to the device and Or Serious injuries 10 1 After Use Maintenance CardiAid should be subject to maintenance by Cardia International or a Cardia International authorized service provider after every use This ensures that CardiAid is in good condition and ready to use when needed again During this maintenance main battery and electrodes are replaced the incident data is obtained from the device and some function tests are performed Also the emergency kit is replaced if
29. he process by which the shock is delivered varies according to the version of CardiAid being used e In the semi automatic version CT0207RS the user is asked to press a button to release the shock e In the full automatic version CTO207RF the device warns the user not to touch the patient and then proceeds to releasing the shock automatically For CT0207RS 6a When the device is ready for defibrillation the instruction Press the flashing shock button is heard At this moment also the LEDs around the shock button start flashing and the button is activated This instruction is repeated with a signal tone until the shock button is pressed Press the shock button to deliver the shock 18 4 Operation For CT0207RF 6b When the device is ready for defibrillation the instruction Shock will be delivered s heard with a repeating signal tone until the device delivers the electroshock automatically 7 After the shock delivery the instruction Shock delivered is heard The device continues analysing heart rhythm while shock is being prepared If the heart rhythm changes during this period defibrillation is aborted Danger There is always a risk of electrocution for the user and the by standers Make sure that UEN nobody touches the patient and there is no electrical connection in the surrounding or on the floor which may transmit electricity Otherwise life threatening injuries may occur for the user and the by standers
30. ic life support CPR and guides the user with verbal instructions and metronome During the incident duration of use and number of shocks delivered can be heard by pressing info button CardiAid also records the ECG and event data in Its internal memory and this data can be obtained from the device as a report Below the functions of the devices are explained briefly and also will be explained in further detail through this user manual Visual and Acoustic Instructions for the User CardiAid is designed to guide the user with verbal instructions together with pictures flashing lights of different colours at the same time thus maximizing the performance CardiAid starts verbal instructions as soon as its cover is opened and guides the user step by step through the resuscitation process Simultaneously clear images support the verbal instructions The pictures are simple and explanatory the flashing lights are designed to emphasize the pictures and buttons with white flashing light showing the stage of the process and red flashing light only indicating the shock button In this way all steps are ensured to be implemented accurately even if the user has limited knowledge or experience in resuscitation 6 1 Introduction to the Device ECG Analysis and Recording When electrodes are placed on the patient correctly CardiAid immediately starts analysing and recording the ECG According to the result of this analysis CardiAid deci
31. is ready to deliver shock 12 Shock Button only for CT0207RS Shock button starts flashing after shock is prepared This button is pressed to deliver electroshock 13 Info button When pressed an audible notification indicating the duration of use and number of shocks applied is heard 14 Repair Symbol The device should not be used if the repair symbol is flashing or lighting In this case it should be repaired by Cardia International or an authorized service provider of Cardia International 15 Battery Symbol The device is not ready for use if the battery symbol is flashing or lighting In this case contact Cardia International or an authorized service provider of Cardia International immediately 16 OK Symbol CardiAid is ready for use if the OK symbol is flashing while the device is switched off GD ENGLISH cen ENGLISH 1 Introduction to the Device 1 1 Intended Use CardiAid is a public access defibrillator PAD i e an automated external defibrillator AED which is available for public use CardiAid can be used for the resuscitation of patients older than 8 years gt 25kg with standard electrodes and patients 1 to 8 years old lt 25kg with special paediatric electrodes If a patient displays symptoms of a cardiac arrest due to ventricular fibrillation or ventricular tachycardia CardiAid can be used to deliver the required defibrillation therapy directly on the site of the emergency The user is guided through the resusci
32. ly 1 Check the status indicator symbols while CardiAid is in stand by mode the cover is closed If the OK symbol is flashing in stand by mode CardiAid is ready for use 2 Open the cover of CardiAid If the following conditions are met the device is ready to use e All lights and status indicator symbols light simultaneously for a short period of time e Then OK symbol lights continuously e CardiAid starts giving verbal instructions Close the cover again and make sure that the device is in stand by mode If verbal instructions stop and OK symbol starts flashing CardiAid is ready for use Inspect the appearance of the device Check if the device has external damage If the device is damaged it shouldn t be used Check whether all accessories are complete and unused Missing or faulty parts should be renewed immediately Check whether the electrode connector is plugged in the socket correctly If the electrode plug is not connected correctly press the plug firmly to the socket 7 Check whether the electrode plug electrode cables and the electrodes are in good condition If the plug cables or the pack is damaged electrodes should be replaced immediately 8 Make sure that the electrode pack has not passed its expiration date If it is expired the electrode pack should be replaced immediately ow D ol o 22 Danger 7 Troubleshooting Inspection repair and other maintenance actions can be performed only by
33. mber of shocks delivered may be obtained Press info button to obtain this information Information can only be provided while electrodes are not connected or the basic life support is being performed The info button is not active during heart rhythm analysis and shock delivery phase If info button is pressed at these stages the information will be provided when CardiAid proceeds to basic life support phase or the electrodes are disconnected 4 3 After Using CardiAid e Remove the plug of the electrodes from the socket e Close the cover of the device e Contact Cardia International or a Cardia International authorized service provider immediately after use e Remember that electrodes and the emergency kit are disposable and should be replaced after use 4 4 Operation Documentation Operation Data The following information is saved automatically in the internal memory of the device for every use e Date and time of use e Patient s ECG e Time of each voice prompt e Time of important points in resuscitation like when the device starts and finishes the analysis what the result of the analysis is and when the shock button is pressed e Time and number of shocks delivered Contact Cardia International or a Cardia International authorized service provider immediately after use 20 5 Hygien CardiAid can be cleaned by a piece of cloth which is moistened but not saturated with a simple disinfectant Caution N Do not immerse CardiAid or
34. or moved during defibrillation Do not touch metal objects or equipment which are in contact with the patient during defibrillation Caution N Apply the electrodes on patient s bare chest as shown on the electrode pads Applying electrodes incorrectly may cause faulty analysis of heart rhythm and or faulty or inefficient defibrillation 12 2 User Manual Caution In order to prevent faulty interpretation of ECG data make sure that the patient is lying still not being touched or moved while CardiAid is analysing heart rhythm Do not perform basic life support CPR during rhythm analysis gt Warning Before delivering the electroshock make sure the patient is disconnected from other medical devices which do not have defibrillation protection Warning Although CardiAid is one of the safest devices in its class remember that wrong interpretation of heart rhythm may be possible Warning Make sure that the electrodes are placed firmly to the patient s chest If not air between the patient s skin and electrodes can cause burns gt P P Electrodes Caution Only use original electrodes supplied with CardiAid CardiAid CT0207RS and CardiAid CT0207RF should be used with CardiAid CR 13A Adult Defibrillation Electrodes or CardiAid R 13P Paediatric Electrodes gt p Caution CardiAid CR 13A Adult Defibrillation Electrodes should be used for patients older than 8 years or weighing more than 25kg CardiAid C
35. patient s bare chest even though the electrodes are placed Electrodes are not placed correctly Press the electrodes firmly Be sure that the chest is dry and not very hairy Remove excessive hair if necessary Electrodes are defective Change electrodes There is a malfunction with he device Contact Cardia International or an authorized service provider immediately Repair symbol is lighting continuously Device is not ready for use There is a malfunction with he device Contact Cardia International or an authorized service provider immediately No visual message No acoustic message There is a malfunction with Close the cover and open the cover again If the problem the operating manual None he davice persists contact Cardia CardiAid cannot be switched on International or an authorized service provider immediately Verbal instructions i I Contact Cardia International or _ There is a malfunction with Any cannot be heard while ihe devica an authorized service provider CardiAid is operating i immediately Any Any Contact Cardia International or There is a malfunction with ied j id Shock cannot be delivered even though the device an authorized Service provider shock button is flashing immediately Any Any Contact Cardia International or Any The device is not operating
36. re flashing during stand by No acoustic message The electrodes are not connected to the device Plug the electrodes to the device OK Symbol and Repair Symbol are lighting Plug electrodes The electrodes are not connected to the device Plug the electrodes to the device O 0 Ch Cdl during operation continuously durin into socket s m ies 9 Wrong electrodes are Be sure that original CardiAid operation being used electrodes are being used Device cannot be used Contact Repair Symbol is i I F nae x i Signal tone in There is a malfunction Cardia International or an flashing during x I every hour with the device authorized service provider stand by x mmediately r Device cannot be used Contact Repair Symbol is Pa s ae f No acoustic There is a malfunction Cardia International or an lighting continuously message with the device authorized service provider immediately 23 GD ENGLISH G ENGLISH 7 Troubleshooting Failure Messages of CardiAid for a period of time during operation Cause Action Visual Acoustic Status indicators CardiAid can be used only in None do not light or flash Any Problem with LEDs emergencies Contact Cardia International or an authorized service provider immediately OK Symbol is lighting continuously during operation Stick electrodes on the
37. rodes This instruction can be deactivated by an authorized service provider instruction is heard Position the patient on his back on a non conductive and dry surface Remove clothing from patient s chest Patient s chest should be dry and not very hairy If necessary remove hair using the razor in the emergency kit wl SS TI 3 Stick electrodes on patient s bare chest Open the package of the electrodes Stick electrodes on patient s bare chest as shown on the electrode pads Press the electrodes firmly to guarantee a good contact The instruction Stick electrodes on patient s bare chest is repeated every 8 seconds until electrodes are placed correctly to enable the heart rhythm analysis If an electrode is detached or damaged the instruction is repeated until the contact between the electrodes and the body is re established Caution N CardiAid CR 13A Adult Defibrillation Electrodes should be used for patients older than 8 years or weighing more than 25kg CardiAid CR 13P Paediatric Electrodes should be used if the patient is 1 to 8 years old or weighs less than 25kg Therapy should not be delayed to determine the exact age or weight of the patient 17 G ENGLISH cen ENGLISH 4 Operation Caution N During the whole process make sure that electrodes are placed firmly on chest and are not damaged 4 Do not touch the patient from now on Analysing hea
38. ronment specified below The customer or user of the device or system should make sure that it is operated in suc h an environment HF emissions according to CISPR 11 Group 1 CardiAid uses HF energy only for its internal functions For this reason its HF emissions are very low and it is not likely that it will interfere with neighbouring electronic devices HF emissions according to CISPR 11 Class B CardiAid is suitable for use in all establishments including Emissions of voltage fluctuations flicker N A residential establishments with similar purposes which according to IEC 61000 3 2 are directly connected to a public power supply which also supplies buildings used for residential purposes Emissions of voltage fluctuations flicker N A according to IEC 6 000 3 3 Recommended safety distances between portable and mobile telecommunication devices e g mobile telephones and the measuring device Power rating of the HF device in W Safety distance depending on transmission frequency in m 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum ou m can be determined using the equation applicable to the frequency of the transmitter whe power rating of the transmitter in watts W according to the transmitter manufacturer NOT
39. rt rhythm These instructions are heard when electrodes are placed correctly enabling the analysis of the heart rhythm ECG Simultaneously the green light and LEDs around the second instruction field in the middle light which indicates that the patient should no longer be touched or moved Caution N Patient should not be touched or moved during heart rhythm analysis Do not perform basic life support during the analysis This may cause wrong interpretation of the ECG and delay in the defibrillation process which can be life threatening If the patient is touched or moved during analysis which cause interruption in the analysis a signal tone and the warning Movement detected are heard Caution When warning Movement detected is heard check for the cause of the interruption If the patient is on a vehicle stop the vehicle After the heart rhythm analysis CardiAid decides whether shock is required The device proceeds with verbal instructions according to the results of the analysis These instructions will be explained in the following sections Shock Necessary and Shock Not Advised Shock Necessary 5 If a shockable rhythm Ventricular Fibrillation VF or Ventricular Tachycardia VT is detected instruction Shock necessary Do not touch the patient from now on is heard and CardiAid starts preparing the electroshock automatically The instruction Preparing shock is heard next Attention N T
40. s Temperature limits Max 2 weeks Humidity Air pressure Protection class Free drop Electromagnetic compatibility IEC 529 IP55 Dust protected protected against water jet IEC 601 1 1988 A1 1991 A2 1995 1 2 2007 12 ition rare use C ILCOR 2010 SELF TEST Schedule Automatic daily monthly and when the device is switched on Timing Can be programmed by factory settings Scope Battery electronics software charging DEFIBRILLATION ELECTRODES Delivery status Disposable self adhesive single use electrodes ready for use sealed and packed OE sanan ith connector outside of the package Polarization Not polarized Exchange is accepted Cableilengthi enei aaeeea eee ieia repai TSE EEEE EEA otal tire lee easels 130 cm Active surface area 166cm2 adult 86cm2 paediatric Shelf Life 42 adult CR 13A 36 paediatric CR 13P months from date of manufacture Transportation Storage Between 0 C and 50 C ENERGY SOURCE Dimensions x w x h in mm Weight aaa K 665 930 g Shock capacity Up to 210 shocks MinIMUM Capacity ta uuu usa aan uti Aas ea enemas 100 shocks x KKK Monitor capacity Nominal capacity Battery replacement FUS022 s issons Stand by Period Real Time Clock battery lifetime with a new battery pack 20 C at low energy setting at lowest sound level DEFIBRILLA
41. scessssessnscesssssssnscsssesssnsessnscesssecssusecsusessssecssseessusessssecsuseceneeeseseseess gt 90 Specificity NSR Z Asyst0 e s ec cacstassessasiuzenvecsecdseeuctaraiytacovesszetedaaastedacriovesdaststiasislssenssavetuassatas sedis EEEN gt 95 Report of analysis system can be found in Technical Service Manual Appendix 1 OPERATION Automatic switch on when the cover is opened One button Operation for PE oku E CT0207RS full automatic operation for CTO207RF Info button Announcement of the elapsed time and number of shocks since device started when info button is pressed E A E gation gated Self explanatory illuminated symbols traffic light principle Device status indicator symbols OK Symbol Battery Symbol Repair Symbol for self test result Verbal instructions Signal tone when in use Signal tone in stand by mode for device failure or low battery Bluetooth Only for service provider Operating elements Class 2 4dBm Maximum Output Warnings Medical electrical equipment should be subjected to special precautions regarding EMC The following EMC Guidelines must be observed during installation and operation of the device Portable and mobile equipment using RF communications may affect medical electrical equipments 30 12 Technical Information Guidelines and manufacturer declaration Electromagnetic emissions CardiAid is intended for operation in the electromagnetic envi
42. tation process with clear and comprehensible instructions The device automatically records and analyses the ECG signal and if required prepares Itself to deliver a shock to the patient The process by which the shock is delivered varies according to the version of CardiAid being used e In the semi automatic version CT0207RS the user is asked to press a button to release the shock e In the full automatic version CTO207RF the device warns the user not to touch the patient and then proceeds to releasing the shock automatically Important CardiAid should be used only for the purposes described above 1 2 User Qualification In most countries public access defibrillators PAD s like CardiAid can be used by any rescuer who is present when a person has sudden cardiac arrest In some countries CardiAid can be used only by rescuers who are qualified with training in basic life support use of automated external defibrillators and use of CardiAid 1 3 Description of the Functions CardiAid is used to deliver defibrillation to a person having sudden cardiac arrest due to ventricular fibrillation or ventricular tachycardia It analyses the heart rhythm of the patient and decides whether an electroshock is necessary or not If one is necessary it prepares the shock automatically The shock delivery method depends on the model used semi automatic or fully automatic After the shock or when no shock is advised CardiAid directs the rescuer to bas
43. this user manual carefully to ensure safe and effective use of CardiAid and to be prepared in case of an emergency If you have additional questions about information in the user manual you may contact the local distributor or Cardia International directly Keep this manual where it can be reached easily The following safety warning icons are used throughout the manual Danger The icon defines a danger which can result in serious injury or death DEM Cu Caution N The icon defines a possible danger which can result in serious injury or death Warning N The icon defines a possible danger which can result in simple mild injury This symbol is also used to indicate user errors which can result in damage to the device Attention This icon provides necessary additional information GD ENGLISH cen ENGLISH 2 User Manual 2 2 Labels on the Device and its Accessories sN 2014 CardiAid Public Access Defibrillator Model CT0207RS www cardiaid com Type Plate Label CardiAid Public Access Defibrillator i ASE x Z Cardia International A S Hersegade 20 4000 Roskilde Denmark Made in Europe CardiAid Public Access Defibrillator IP55 Battery Pack for CT0207 CT0207RS CT0207RF Model No CA 4BP 12V 15Ah Alkaline Cardia International A S Hersegade 20 4000 Roskilde Denmark 4 d QFO
44. used The next periodical maintenance should be performed at regular time See Section 10 2 10 2 Periodical Maintenance 2nd and 4th Year Periodical Maintenance CardiAid should be subject to periodical maintenance at the end of 2nd and 4th years after purchase Date of next maintenance is indicated on the battery life label on backside of the device During this maintenance main battery and electrodes are replaced and some function tests are performed Caution N The maintenances should be performed no later than the date on the battery life label The device cannot be used unless the maintenances are performed on time In some countries like Germany legal period of Technical Safety Check TSC is 2 years according to Medical Products Operation Regulation Article 6 In these countries CardiAid should be subjected to TSC during 2nd and 4th year periodical maintenance 6th Year Maintenance In order to be able to continue using the device after 6th year CardiAid should be subjected to a comprehensive maintenance at the end of Bth year after purchase In addition to the periodical maintenance the status of technical components is checked This maintenance is performed at the factory Please contact Cardia International for details 27 G ENGLISH cen ENGLISH 11 Package Content Standard package of CardiAid contains the e CardiAid AED including battery e CardiAid Protection Bag e CardiAid CR 13A Adult Defibrillation
45. vicinity of equipment marked with the symbol nonionizing radiation NOTE At 80 MHz and 800 MHz the separation distance for the higher freq NOTE These guideli reflection from struct ency range applies nes may not apply in all situations Electromagnetic transmission is affected by absorption and ures objects and people Field strength 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 canno be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be made If the measured field strength in the location which the CardiAid Public Access Defibrillator is used exceeds the applicable RF compliance level above additional measures may be necessary such as reorientation or relocating the CardiAid Public Access Defibrillator Above frequency fields between 150 KHz and 80 MHz field strength should be less than 3 V m 34 12 Technical Information 12 2 Pulse Form The delivered shock is a biphasic current based shock Two different energy levels are implemented in the device a low energy shock and a high energy shock The current based shock has the advantage that the delivered energy depends on the patient impedance Myocardium damage caused by high electrical current applied to patient with low imp
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