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User Manual Defibrillator - Tecno-Gaz

1. Auxiliary Input Output s The AED provides Infrared communication port SD card ports DESCRIPTION OF THE AED Parts of the Top and Right Panel Figure 2 TECNOHEART plus Parts of the Top and Right Panel 10 Cover Status indicator Electrode connector Action Icons Patient mode switch Shock Button Scrolling button SD card slot Infra red communication port Handle Battery Parts of the Rear Panel 1 Table 1 Parts of the Top and Right Panel The cover is designed to protect the action icons patient mode button and shock button The status indicator indicates the status of the unit the temperature and the battery level The electrode connector is used to connect the electrodes The LED indicator flashes red under the corresponding action icon Once the user has identified the patient based on type select patient mode between adult or paediatric patient using the mode switch Once preparation for the electric shock is completed the current shock button will flash Press the current Shock button to deliver the shock The scrolling button opens the cover to turn on push the scrolling button to the right The SD card is required to save data and update AED firmware The infra red communication port is used to communicate with the PC AED Handle and Battery Handle Battery 2 Battery removal button Figure 3 Parts of the Rear Panel Symbols and Labels The following symbols can be used herein
2. 25 3 3 195 50 190 75 185 100 195 125 190 150 185 175 180 Defibrillation for paediatric patients Shock Pulse amplitu Pulse amplit Energy Resistanc de 1 ms ude 2 ms Deliver e ed 0 J 25 51 50 50 75 49 100 51 125 50 150 49 175 47 Controlled by the patient analysis system for automatic operation Normally lt 12 seconds Normally lt 13 seconds After the AED advises a shock AED continues to monitor the patient ECG rhythm during a maximum of 20 seconds until the shock button is pressed If the ECG rhythm changes to a non shockable rhythm the AED will disarm If the shock button is not pressed during 20 seconds the AED will disarm 40 ECG Performance Analysis Rhythm class VF shockable TP VF shockable FN VF shockable sensitivity VT shockable TP VT shockable FN VT shockable sensitivity Non shockable FP NSR PVC APB SVP Asystole Non shockable TN Specificity Database for ECG analysis e From the official database of the AHA American Heart Association AHA DB 747 82 90 1 3075 100 0 MIT DB 19 0 100 0 0 17150 100 0 CU DB 220 18 92 4 1254 100 0 VF DB 566 53 91 4 394 63 86 2 6774 gt 99 9 Total number of sample size 1552 153 91 0 gt 90 394 63 86 2 gt 75 1 28249 gt 99 9 299 e From the official database of MIT Massachusetts institute Technology CU DB The Creighton University Sust
3. Do not touch the patient loudly Examine the entire patient carefully to make sure there is no contact before pressing the Shock button Do not touch the patient during the AED analysis phase or as the shock is being delivered The defibrillation energy could cause injury As long as the AED is used according to the instructions and no one is touching the patient when the Shock Button is pressed there is no risk of damage to the rescuer or bystanders The AED cannot deliver the shock unless the electrodes are applied to the patient requiring a shock to his her heart Notes Follow the warnings and precautions for further details 27 28 MAINTENANCE A A gt gt WARNING Failure to apply the maintenance regulations contained in this manual can damage the AED or cause it to operate defectively Keep the AED in good conditions according to the instructions WARNING Do not allow any liquids to penetrate the AED Avoid pouring liquids on the AED or its accessories Pouring liquids on the AED can damage the device or cause fires or electric shocks Do not sterilise the AED or its accessories WARNING Do not immerse any part of the AED in water or other types of liquid Contact with liquid can cause serious damage to the AED or cause fires or electric shock WARNING Do not attempt to heat the electrodes with a source of heat exceeding 35 C WARNING Do not clean the AED with abrasive materials detergents o
4. in the relative documents or appear on system parts or packaging Table 2 Symbols used on the Panel and Labels Symbols Description Symbols Description Readv for use A N Attention consult the ay attached documents 09 Not ready for use C CE Marking 0434 21m Ambient altitude limits Baler isye ms for transport storage AA 2 Ambient humidity limits oe EMP Sas E O for transport storage a soc Ambient temperature atex ns Latex free save limits for transport storage OS Best before date gt Refer to the instructions tt Fragile handle with care UEA This side up tt 4 anal Manufacturer Keep dry mi Manufacture date 191 Type CF Defibrillation proof REF Reference sales code IP54 Water and dust proof SN Serial number A Single use device only Manufacturer s European i Authorised w PJ Instructions for disposal Representative WEEE ER European Authorised Representative 10 CONFIGURING THE AED A WARNING To ensure excellent performance of the AED and avoid failure do not expose the device to extreme humidity including direct exposure to rain This form of exposure could lead to poor AED performance or failure Refer to the Specifications section AN WARNING Using damaged or expired AEDs or accessories could cause the device to fail and or cause damage to the patient or user Unpacking and inspection The AED is shipped in a cardboard box Check th
5. a gag a agi inlined gi 31 EJECUTE IMAN ANCES x2 sara bisriice eo as ga a 31 Replacing Me Electrodes o teo saa 31 AED MANNCNANCC cs sida aa a aaa a a la atada 32 TROUBLESHOOTING cias oa 33 ETE E GL a aana aaa a ns GaGa pinecone Gass ed nd EAA ead ale AE a aa AAA ad oe aE acu aa KB a aga 33 COMCCIIVE MICAS UNOS A A A A a ag a a pad a a ie 33 EMI Electromagnetic INtCrferenCe ccccsccsccccscssccnsauseccnscsescnseusessausecenscuesensauseessansesensauesensaussessanssens 34 Obiaining TeCchniGal ASIS AN ee ee eee ee a ese ccc 34 GLOSSARY add iaa 35 TEGHRNIGAL SPECIFICATIONS lt is 37 COMO at nat oo ad a a Dak a ono a aa da Ba Bi a aaa 42 Manu lact rer declara tlon saras ain A A a aa baana ada Bag a a aa pa d aa a ada ia 45 ILLUSTRATIONS Figure 1 TESNORHEART PIUS casa cios 7 Figure 2 TECNOHEART plus Parts of the Top and Right Panel oocccoocccccnccoccccocnc 7 Figure 3 Parts of the Rear Panels icccoccccceiscsccdsccidcneednmtsatecnavinsncaastiddaasudepecexcegesewendensedenduskesolensds 8 Figure 4 Changing the handle battery Right panel cccocccoccccccncccnccccnconnnoncncnnnnnncnonononoss 15 Figure 5 Changing the handle battery Top Panel oocccccccoccccocicoccconcnconnccncnconcnnncnonononons 16 FIGure 76 Patent mode Willis da 24 Figure 7 TECNOHEART plus Action icon Step 1 o ooccccccccccocccoccconnconncnnncnnnonncnnononononononos 24 Figure Placement Or Electrodes mii e ed alos leed 24 Figure
6. a patient connected to the electrodes could damage the electrodes Change the electrodes if they are damaged during use or handling The AED is designed to treat sudden cardiac arrest SCA We recommend using the device only for the treatment of SCA victims and if e They are unconscious e Not breathing e Do not have a heartbeat only health care staff If the person is unconscious but you are not sure he she is affected by SCA start CPR If necessary apply the AED and follow the voice instructions AHA 2010 guidelines for CPR and ECC The AHA 2010 guidelines for CPR and ECC are based on the broadest and most recent revision of the literature on resuscitation ever published the International Consensus Conference on CPR and ECC Science With Treatment Recommendations organised in 2012 by the International Liaison Committee on Resuscitation ILCOR Bystanders first responders and healthcare providers play an essential role in performing CPR on victims of cardiac arrest Also expert operators can provide excellent pre and post arrest assistance Additional amendments to the AHA 2010 guidelines for CPR and ECC The BLS algorithm has been simplified and the Look Listen and Feel for breathing step has been removed from the algorithm Performing these steps is unreliable and requires a considerable amount of time use for lay rescuers Lay rescuers must adopt the Hands Only CPR procedure chest compressions only The H
7. analysis phase may cause interference with the diagnostic process Avoid touching the patient during the analysis phase The AED will play a voice message when it is safe to touch the patient WARNING The AED delivers electric shocks that can cause serious damage to operators and bystanders Make sure no one is touching the patient while the shock is being delivered Notes It is only possible to use TECNO GAZ electrodes Using other types of electrodes can cause damage to the patient and to the AED Notes If the AED is powered on outside of the ambient operating condition range set forth in this manual the temperature status will flash In this case expose the AED to suitable temperatures prior to operation 23 1 Make sure the status indicator reads O 2 To open the cover move the Scrolling button to the right 3 Turn the AED off by closing the cover 4 The AED automatically runs the Power On Self Test 5 The result of the test will be displayed on the status indicator and will provide a voice message e Self test passed Voice message Unita ok unit ok Status indicator O e Self test failed Voice message Unita non funzionante unit not working Status indicator X 6 If the electrodes are connected and the Patient mode is selected the device will play the following voice message e The Patient mode button is on the left Elettrodi per adulti Electrodes for Adults e The Patient mode button is on
8. of To remove the batteries accumulators refer to the specific indications of the manufacturer Should the user inappropriately dispose of the devices batteries and accumulators he she shall be punished by law 30 Returning the AED and System Parts To return the AED and or its accessories contact the qualified staff or your local supplier The AED does not require any other type of scheduled maintenance other than cleaning battery maintenance and service activities required by the user s establishment For further information consult the AED maintenance manual The qualified staff at the user s establishment can periodically perform checks on the AED If you require assistance contact qualified staff or your local supplier Periodic Safety Checks It is necessary to perform the following annual checks e Check for mechanical or functional damage to the device e Make sure the external safety labels are legible CLEANING Clean the AED with a soft cloth moistened with one of the following substances e Soapy water e Isopropyl alcohol 70 solution To clean the cables and the electrodes follow the operating instructions provided below in attachment to these parts Avoid spilling liquids on the AED especially near the connectors If liquids are accidentally spilled on the AED clean and dry the device carefully before use If you have any doubts regarding the safety of the AED consult qualified staff or your local
9. premonitory signals or symptoms SCA can also occur in individuals with previously diagnosed cardiac conditions The survival of SCA victims depends on the immediacy of cardiopulmonary resuscitation CPR The use of an external defibrillator within the first minutes of collapsing can considerably increase the patient s possibility of survival Heart attack and SCA are not the same thing although a heart attack can lead to SCA If the symptoms of a heart attack develop pain pressure shortness of breath sensation of compression on the chest or other parts of the body seek immediate emergency medical attention Heartbeat The normal electric rhythm of cardiac muscle contraction to create blood flow throughout the entire body is known as Sinus Rhythm Ventricular fibrillation VF caused by chaotic electrical signals in the heart is often caused by SCA but a shock can be administered to re establish sinus rhythm The treatment is called defibrillation The AED is designed to automatically detect ventricular fibrillation VF and perform defibrillation on the victims of sudden cardiac arrest Ventricular Tachycardia Ventricular Fibrillation This is a potentially lethal heartbeat which can be cured through AED treatment Sinus Rhythm Sinus Rhythm is the normal electric rhythm of cardiac muscle contraction and expansion to create blood flow throughout the entire body Biphasic Shock Biphasic shock is an electrical current that travels
10. safety warnings are provided inside this manual In the manual TECNOHEART plus will be referred to as AED Read the operator manual carefully before use as well as any additional instructions for use and all of the information and precautionary specifications Warnings A Warnings are identified by the WARNING symbol displayed above The warnings identify the danger of potentially dangerous situations death injury or adverse events damaging the patient or the user AN WARNING It is essential that all of the users of an AED notify TECNO GAZ of any accidents when the AED is suspected of having caused death serious injury or disease If you have any concerns that a similar case has occurred you are required to notify TECNO GAZ directly or through your authorised TECNO GAZ supplier AN WARNING The AED must be used by staff trained in CPR manoeuvres and AED use The qualifications for use of the AED must follow local legislation A WARNING The AED can deliver therapeutic electrical shocks The shock can cause serious damage to the operator as well as to bystanders It is necessary to be very careful that neither operator nor bystander touch the AED when a shock is about to be delivered A WARNING The AED was not designed or approved for use in dangerous areas as specified in the American National Electrical Code Articles 500 503 In fulfilment of the requirements of the IEC EN 60601 1 classifications the AED must not be used in
11. the presence of flammable substances air mixtures AN WARNING The AED was designed to operate on unconscious patients who are not breathing and do not have a heartbeat If the patient is conscious or breathing and their heartbeat starts up again do not use the AED health care staff is in charge of monitoring the heat beat AN WARNING Touching the patient during the treatment analysis phase may cause interference with the diagnostic process Avoid contact with the patient and keep him her as still as possible while running the ECG The AED will tell you when it is safe to touch the patient WARNING Keep your distance from the patient during treatment The defibrillation energy delivered to the patient could be conducted through the patient s body and cause a lethal shock to anyone touching the patient WARNING It has been determined that the use of the AED is safe when used in combination with oxygen delivery systems through masks Nonetheless due to the risk of explosion it is strongly recommended not to use the AED near explosive gases This includes flammable anaesthetics concentrated oxygen and petrol A WARNING The same electrodes can be used on Adult and Paediatric patients Adult mode must be used on patients that are 8 years of age or older Paediatric mode must be used on patients who are under 8 years of age or who weigh less than 25 kg 55I1b gt gt bibbBib bl j gt gt Do not use the AED on patients
12. who are under 1 year of age WARNING Correct electrode positioning is crucial It is essential to follow the electrode positioning instructions carefully provided on the labels and during training lt is necessary to make sure that the electrodes adhere well to the patient s skin It is necessary to eliminate any air pockets between the electrode and the skin If the electrodes fail to adhere well to the skin this could affect the effectiveness of the therapy or cause excessive lesions on the patient s skin when an electrical shock is delivered It is normal for the skin to redden following treatment WARNING The AED battery is not rechargeable Do not attempt to recharge open crush or burn the battery as it could explode or catch fire WARNING Keep the electrodes from coming into contact with other electrodes or metal parts that are touching the patient This contact could cause burns to the patient s skin during defibrillation and could divert the defibrillation current away from the heart WARNING Be careful of any possible contact with the conductive part of the electrode the connector line the connectors for cables or any other parts applied to the patient for the safety of the patient him herself WARNING Do not use the unit near or inside pools of water WARNING Do not re use the electrodes on multiple patients WARNING Only use the AED or the accessories according to the methods described in this manual Improper use of
13. 1000 4 2 2009 IEC 61000 4 3 2006 A1 2008 A2 2010 EN 61000 4 3 A1 2008 A2 2010 IEC 61000 4 8 2009 EN 61000 4 8 2010 CISPR 11 2009 A1 2010 EN 55011 2009 A1 2010 ISTA Procedure 1A 2001 IEC 60068 1 1988 A1 1992 EN 60068 1 1994 IEC 60068 2 1 2007 EN 60068 2 1 2007 IEC 60068 2 2 2007 EN 60068 2 2 2007 IEC 60068 2 30 2005 EN 60068 2 30 2005 IEC 60068 2 27 2008 EN 60068 2 27 2009 IEC 60068 2 6 2007 EN 60068 2 6 2008 IEC 60068 2 64 2008 EN 60068 2 64 2008 EN 1041 2008 IEC TR 60878 2003 ISO 15223 1 2011 Biological assessment of Medical devices Part 5 Test methods to assess in vitro cytotoxicity Biological assessment of Medical devices Part 10 Tests for irritation and delayed type hypersensitivity Medical vehicles and equipment road ambulance Medical vehicles and their equipment Air ambulances part 1 requisites for medical devices used in air ambulances Ambient Conditions and Test Procedures for Air Equipment Cardiac defibrillator safety Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms Electromagnetic Compatibility requisites and tests Electrostatic discharge ESD Ed 2 0 Radiated Electromagnetic Field RF Ed 3 2 Power supply frequency 50 60Hz Magnetic field Ed 2 0 Limits and methods of measurement of radio interference characteristics of industrial scientific and medical devices ISM RF emissions Group 1 Cl
14. 5 times e Interrompere la RCP Stop performing CPR Figure 12 TECNOHEART plus Action Icon Step 4 Notes If the device plays the following voice message as the AED is analysing perform the actions below e Rhythm changed Shock cancelled Move to Step 1 Move to Step 2 ECG analyzing again non shockable rhythm Move to Step 4 or Move to Step 1 Move to Step 2 ECG analyzing again shockable rhythm Move to Step 3 Move to Step 4 Note If the pads connector has been removed starting from Step 1 If not starting from Step 2 e Shock button not pressed Move to Step 4 Perform the CPR e Low battery change the battery The user changes the battery switch it on by lifting the cover Once the power on self test is finished use the device strictly following the instructions AHA 2010 provisions When the shock has been delivered the device will play the following voice message e Il paziente pu essere toccato in sicurezza It is safe to touch the patient e Iniziare la RCP Start CPR Follow the sound of the AED metronome to count the compressions The unit will emit a sound equal to at least more than 100 beats per minute according to the current guidelines Also note that the Iniziare la RCP Start CPR icon flashes at the same time and at the same speed providing further assistance At this point suitable chest compressions require a dept
15. 9 TECNOHEART plus Disconnect icon of the electrodes occoocccoccccccncconcnns 24 Figure 10 TECNOHEART plus Icon of Action Phase 2 oocccccnccccccccncccnncncncncncnonnnnnnnnnos 25 Figure 11 DAE Icon of Action Phase B ccccccccccncccncccccnocncocnocanononnocnnononnonnnnonnnonaninnnnnnanos 25 Figure 12 TECNOHEART plus Icon of Action Phase 4 occcoocnccccccccnccnnccncncnoncnocnnnnnnnnos 26 Figure 13 Date of expiry of the electrodes ccoocccccnccocncccccconnoconncncnononnonononanonannonannonnnenons 32 TABLES Table 1 Parts of the Top and RIght Panels ida 8 Table 2 Symbols used on the Panel and Labels ccoocccocncconncccnccocncncnncnnnnnnnonanonnnonnnnos 9 Table 35 ACCOSSOMOS tesis cla 11 Table 4 Battery Stat s ICON a aaa a diia iia 17 Table 5 Electromagnetic emissions IEC6O0601 1 2 ocoocccccnncocncoccncccnccocnconncnnnnonononnnnnonnnoncnnns 45 Table 6 Electromagnetic Immunity IEC60601 1 2 o oocccocccccncccccncccnconcnconnconcnonononanonnnoconnnnos 45 Table 7 Electromagnetic Immunity IEC60601 1 2 continued from previous page 46 Table 8 Recommended Safety DIStances oooccccccccccccocncoccconcncnonnnncncnnnononnonononnnnnonnnnnnncnanonos 47 Table 9 Cables MEGONO A aia stars tate tonta reo ans ae 47 SAFETY WARNINGS General Safety Warnings This section contains important safety warnings regarding the general use of TECNOHEART plus Additional
16. ENGLISH Defibrillator DAE User Manual TECNOREARTp US Automated External Defibrillator A uy y TECNO GAZ EU Representative OBELIS S A Bd G n ral Wahis 53 1030 Brussels Belgium Manufacturer M MEDIANA Co Ltd 132 Donghwagongdan ro Munmak eup Wonju si Gangwon do Korea Tel 82 2 542 3375 82 33 742 5400 Fax 82 2 542 7447 82 33 742 5483 Sold in Private Label by TECNO GAZ S p A a single member company Strada Cavalli n 4 43038 Sala Baganza Parma Italy Tel 39 0521 8380 Fax 39 0521 833391 Manual code 021210008 Edition 0 on date 2014 09 18 Copyright 2014 All rights reserved 0434 Directive e The Copyright law does not allow the total or partial reproduction of this instructions manual without prior authorisation e The contents of this manual are subject to change and modification without forewarning e The data contained in this manual are considered correct In case of objectionable content please contact our assistance centre e The manual will be subject to review if any pages are missing or in the wrong order Warranty e Any faults or damage affecting the device caused by the following situations during the warranty period are not covered by this warranty e Installation installation due to relocation maintenance and repairs carried out by staff or technicians that are not authorised by TECNO GAZ e Damage to TECNO GAZ products caused by the use of products of ot
17. O and 43 C Between 32 and 109 4 F Storage Between O and 43 C Between 32 and 109 4 F Between 5 and 95 RH Non condensing Battery LIMnO Disposable Long lasting Primary Cell 15V 4200 mAh 2 years from the date of manufacture 5 years from the date of manufacture A minimum of 200 electrical shocks not counting the CPR period between the defibrillation treatment or 10 hours of operation at 20 C Ambient Conditions Operation Between 0 and 43 C Between 32 and 109 4 F Storage Between 0 and 43 C Between 32 and 109 4 F Between 5 and 95 R H non condensing 39 Defibrillation Waveform Parameters of the waveform A kB WC Peak A 4 5 Time ms Shock control Shock Time Shock Analysis Time Disarm Defibrillation Waveform The parameters of the waveform are adjusted automatically based on the patient s defibrillation impedance Inthe diagram on the left A is the amplitude of beat 1 and B is the amplitude of beat 2 of the waveform C is the interval between beats is the peak current and is the final current The AED delivers electric shocks to charge impedances be tween 25 and 175 ohm The duration of each waveform p ulse is adjusted dynamically based on the delivered shock to compensate for variations in patient impedance as illus trated below Defibrillation for Adults Shock Pulse Pulse Energy Resistanc ampl amplitude 2 Delivered e itude ms J Q 1 ms
18. SCA may require the user to kneel Local Requirements Check with your state health department to see if there are any local or state requirements about owning and using an AED You can find contact local supplier or Mediana technical support for learning about your country or state Device Tracking This AED may be subject to tracking requirements by the manufacturer and distributors per local regulation If there are tracking requirements in your local please notify your local distributor when the AED has been sold donated lost stolen exported or destroyed Information on the Manual This manual explains how to assemble and use the AED Read the entire manual including the Safety Warnings section before using the AED Identifying the AED Configurations This table contains the AED configurations and their names The Reference number and the serial number can be found based on the AED Configuration TECNOHEART plus AE001Z12 Standard AED 4 action icons Note The alphabet E can be added as the last digit of reference number in accor dance with the region Features for the AED Physical Mechanical The AED is an automated external defibrillator AED used for the fast delivery of defibrillation electric shock therapy which can be battery operated Electrical The AED has an internal battery which is the non rechargeable battery Display The indication is LED indicator that flashes red LED under the relevant action icon
19. able for Infra red communication To recover and view information regarding treatment administered with the AED Also AED Event Review Software can be used to configure the AED Additional Information If you have had the chance to use the AED or if you wish to receive further information on the AED its accessories or any other product contact TECNO GAZ 36 TECHNICAL SPECIFICATIONS Electric Defibrillation shock Biphasic Truncated Exponential BTE waveform Waveform impedance compensation EN Adult Between 185 and 200J 5 Paediatric Between 45 and 50J 5 Operating mode Semi Automatic ECG Lead II RA LL Patient impedance Between 25 and 175 Ohm Heart Frequency Between 20 and 300 per minute Precision 1 per minute Detection V F greater than or equal to 200 uV V T greater than or equal to 160 per min Connection to the Confirmation of the connection and emission of voice connector messages Filter Between 0 5 and 30 Hz Indications Controls Standard Scrolling button Shock button Patient mode button Indicators Visible The ICON LCD Status indicator Unit status Battery status Temperature status LED patient mode LED Audio signals Speaker Voice messages Beeps CPR indicator Physical characteristics Measurements 240 x 294 x 95 mm LxHxD Weight Approx 2 65 kg including the battery excluding the electrodes 37 Ambient Conditions Self test Temperature Relative Humidity Altitude Shock Vibr
20. ained Ventricular Arrhythmia Database VF DB MIT BIH Malignant Ventricular Arrhythmia Database ECG rhythm to determine whether it is advisable to deliver a shock e Ventricular fibrillation with an amplitude that is greater than or equal to 0 2mV e Ventricular Tachycardia with a heart frequency greater than or equal to 160 bpm 41 Conformity Entry Classificatio n Type of protection Operating mode Protection rating General Standard IEC 60601 1 2005 A1 2012 EN 60601 1 2006 AC2010 IEC 60601 1 2005 A1 2012 EN 60601 1 2006 AC2010 IEC 60601 1 2005 A1 2012 EN 60601 1 2006 AC2010 IEC 60529 2001 EN 60529 1991 A1 2000 93 42 EEC as amended by 2007 47 EC 21CFR820 2012 19 EU 2011 65 EU 93 86 EEC 2006 66 EC as amended by 2008 103 EC ISO 13485 2003 EN ISO 13485 2003 ISO 14971 2007 EN ISO 14971 2012 IEC 60601 1 2005 A1 2012 EN 60601 1 2006 AC2010 IEC 605292001 3 EN 60529 1991 A1 2000 ISO 14155 2011 EN ISO 14155 2011 AAMI HE75 2009 IEC 623042006 3 EN 62304 2006 IEC 60601 1 6 2010 EN 60601 1 6 2010 IEC 62366 2007 EN 62366 2008 IEC 60601 1 9 2007 EN 60601 1 9 2008 ISO 10993 1 2009 Cor1 2010 EN ISO 10993 1 2009 AC1 2010 Description Internal power supply battery powered CF type Applied parts Continuous IP54 provided by the casing Directive on Medical Devices class IIb Federal Regulations Code Waste of electric and electronic equipment Restr
21. all the AED according to the ambient operating conditions described herein Set things up so that the AED is accessible at all times Train and Inform any possible users of the location where the AED is kept BATTERY OPERATION WARNING Test the battery on a regular basis when the battery voltage is very low A battery that does not pass the test could suddenly stop working gt WARNING Do not use batteries that are damaged wet or leaking WARNING Do not use or store batteries that may have been exposed to high temperatures ATTENTION To ensure the availability of adequate power during an emergency keep a new spare battery pack with the AED at all times ATTENTION If the battery voltage is very low the device may not work ATTENTION If the battery shows any signs of damage leakage or breakage you will need to change it immediately ATTENTION Do not dispose of the battery as urban waste as it may explode during incineration Dispose of used batteries correctly Do not throw the batteries in waste containers ATTENTION Check the battery level on a regular basis Change the battery when necessary ATTENTION Except for inspections if the AED is switched on off or discharged often the battery will not last in standby any longer than stated by the manufacturer gt gt BP Pe Pe BP Battery run AED Operation The AED is equipped with disposable batteries When the AED is battery operated the battery level c
22. an be read from the level indicator The AED battery is the handle If necessary change the handle battery How the change the battery ae o _ _ A S TR 4 Toco gt v Handle battery connector AED connector Handle battery removal button 4 Changing the handle battery Right panel UNa Figur 15 a b c d 1 AED connector 2 Hook 3 Handle battery connector Figure 5 Changing the handle battery Top Panel To disconnect the battery Press the handle battery removal button pull upwards then disconnect the handle battery To connect the battery Tilt the handle battery and hold the handle battery removal button and the AED connector perpendicular as illustrated in Figure 5 Connect the AED and the handle battery using the hook as illustrated in the first figure of Figure 5 When the handle battery is connected to the AED by the hook connect the handle battery connector and the hook on the AED as illustrated in the second figure of Figure 5 When both parts of the connectors are hooked up correctly the device will make a tinkling sound The AED uses disposable batteries Used batteries must be replaced with new batteries Before turning on the AED with fully discharged batteries change the batteries When the new battery is installed the AED will switch on automatically and start the battery insertion self test The AED may switch off when the battery in
23. ands Only CPR procedure is easier for a lay rescuer to perform and can be illustrated and explained over the phone more easily by first responder operators Start chest compressions before performing CPR Compression Open airways Breath instead of Open airways Breath Chest compression There is greater attention to the methods to ensure high quality CPR The following actions have highlighted the importance of high quality CPR Suitable chest compressions 100 120 min At least a 5 cm compression depth with adults Allow the chest to retract completely after each compression Reduce breaks between compressions to a minimum Eliminate excessive ventilation 21 2010 CPR GUIDELINES This Guideline summary summarises the 2010 Guidelines of the American Health Association AHA for Cardiopulmonary Resuscitation CPR and Emergency Cardiovascular care ECC of the American Heart Association and the European Emergency Association This reference material is simple for lay rescuers as well as medical attendants Before installing the AED the user is required to be trained in performing CPR and operating the AED Is the person unconscious Is the person unresponsive Talk to the person and shake their shoulders Ask oth Once you have received a request sk other people for help and take turns performing for help get the AED CPR Open the airways Check for breathing Notes Open the airways check for breathing was r
24. ass B Pre shipping test procedures Packaging Environmental testing Part 1 General and guidance Environmental testing Part 2 1 Test Test A Cold Environmental testing Part 2 2 Test Test B Dry heat Environmental testing Part 2 30 Test Test Db Damp heat cyclical cycle of 12h 12h Environmental testing Electric shock Environmental testing Vibration Environmental testing vibration broad band random digital control and guidance Information provided by the manufacturer with Medical devices Graphical symbols for medical electrical equipment Symbols to be used with medical device labels 43 labelling and information to be supplied Part 1 General requirements ISO 15223 2 2010 Symbols to be used with medical device labels labelling and information to be supplied Part 2 Symbol development selection and validation ISO 7000 2012 Symbols to be used in the device index and synopsis EN 50419 2006 Marking of electric and electronic devices in compliance with article 2 of directive 2002 96 EC WEEE 44 Manufacturer declaration A WARNING To achieve the best performance from the product and maximu m measuring precision use the supplied accessories or TECNO GAZ recommended accessories only Use the accessories according to the manufacturer s instructions for use and the standards of your facili ty The use of accessories transducers and cables other than those speci
25. ation Falling height Resistance to water and dust Temperature Relative Humidity Altitude Cycle Test results Operation Between 0 and 43 C Between 32 and 109 4 F Between 5 and 95 R H non condensing Between 0 and 4 475 m Acceleration 100 G 10 Time 6 msec Number of shocks 3 times axis 6 axes X Y Z Frequency Between 10Hz and 2000Hz Acceleration Between 10 Hz and 100 Hz 5 0 m s Hz Between 100 Hz and 200 Hz 7 dB per octave Between 200 Hz and 2000 Hz 1 0 m s Hz 1m IP54 IEC60529 Storage in the delivery box Between 20 and 60 C Between 4 and 10140 F Between 5 and 95 R H non condensing Between 0 and 12 192 m Every 24 hours 1 week 1 month Power on self test Battery insertion self test The LCD status indicator reads O X Backup and Data Communication Standard SD card Infra red communication port 38 Accessory Specifications Electrodes Battery Battery life in Standby Electrodes Placement Minimum gel adhesion surface Cable length Temperature Relative Humidity Type Voltage Capacity Expiration Date on the original package battery life in standby installed in the AED Shock Temperature Relative Humidity Adult Paediatric Electrodes 2 years from the date of manufacture Disposable electrodes Adult Front side Paediatric Front rear 80 cm 5 Approximately 1 8 m Ambient conditions Operation Between
26. be installed or it may be discharged If the battery is not installed do so See chapter on Battery Operation If the battery is discharged change it Consult the Maintenance section 2 The audio signals do not sound during operation e Do not use the AED contact qualified staff or your local supplier 3 You can hear the audio signals but the voice is not working properly e Re connect the cable or change the speaker 4 The device plays the voice message Connettere gli elettrodi Inserire saldamente il connettore Connect the electrodes Attach the connector firmly e Firmly re connect the electrode connector to the electrode attachment or replace the electrodes 5 The action icon does not flash e Do not use the AED contact qualified staff or your local supplier 6 You cannot hear the voice message very well e Do not use the AED contact qualified staff or your local supplier 7 The battery status indicator does not display 3 bars even though the battery has been replaced e If the battery status indicator does not display 3 bars even though the battery has been replaced do not use the AED and contact qualified staff or your local supplier EMI Electromagnetic Interference WARNING Keep the patient under strict supervision while the shock is being delivered It is possible although improbable that electromagnetic signals radiating from sources outside of the AED can lead to inaccurate values Do not rely e
27. be notified of every occasion that our customers use our products even if treatment is not carried out in case of an accident This information is of vital importance for the on going development and improvement in treating sudden cardiac arrest Recycling and Disposal When the battery or the AED accessories reach the end of their service life recycle or dispose of them according to applicable local and regional provisions Notes We recommend disposing of the AED separately at municipal separate waste collection centres through specific collection systems set up by the government or local authorities Notes The correct disposal of an old device will help prevent possible negative consequences for the environment and human health Notes For further information on disposing of the old device contact the designated MN office in your city waste disposal services or the store where you made the purchase In accordance with art 13 of Legislative Decree July 25 2005 no 151 Implementation of directive 2002 95 EC 2002 96 EC and 2003 108 EC relative to reducing the use of hazardous substances in electric and electronic devices as well as waste disposal and Legislative Decree 188 of November 20 2008 Implementation of directive 2006 66 EC on batteries accumulators and relative waste The symbol of the crossed out wheelie bin displayed on the device battery and accumulator or on the package indicates that both device and the ba
28. cally possible to predict fixed transmitter field intensities such as base stations for radio telephones mobile phones cordless phones terrestrial mobile radios amateur radios AM and FM radio transmission and TV transmission To assess the electromagnetic environment generated by fixed RF transmitters you will need to perform an on site electromagnetic survey If the field intensity measured in the location where the AED is used exceeds the applicable RF conformity level provided above the AED must be monitored for correct operation If you discover anomalous performance it may be necessary to apply additional measures such as re directing or moving the AED Outside of the frequency range of 80 MHz and 2 5 GHz the field intensity must be lower than 10 V m Recommended Safety Distances between Portable and Mobile RF Communication Devices and the AED IEC60601 1 2 46 Table 8 Recommended Safety Distances Recommended Safety Distances between Portable and Mobile RF Communication Devices and the AED The AED is intended for use in electromagnetic environments with controlled RF disturbance The AED customer or user can prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF devices transmitters and the AED set forth below based on the maximum output power of the communication devices Maximum nomina Separation distance based on the transmitter frequency in metres tra
29. d the temperature status is on in specific ambient operating conditions the device will operate correctly Notes When the AED is running in unsuitable ambient operating conditions the temperature status will flash Notes If the AED is set with values outside of the range of the ambient operating conditions for a long period of time it will need more time than usual to recognise the temperature It is necessary to store the AED at the ambient operating conditions set forth herein Installation step 1 1 Putting the battery in the AED 2 The AED status indicator will read X and the battery insertion self test will start up 3 When the battery insertion self test is running a voice message will play Unita ok Unit ok and the status indicator will switch from X to O 4 Take the electrodes out of the package 5 To open the cover move the Scrolling button to the right 6 Connect the defibrillation electrodes 7 To turn the device off close the cover Notes When the electrodes are already connected to the AED in the package take the AED out of the package and refer to the Installation step 2 chapter Notes The electrodes must remain connected to the AED ready for any emergencies Notes Do not open the defibrillation electrode package until use when they are applied to the patient 13 Installation step 2 Make sure the AED is working correctly 1 Change the patient mode by moving the Sc
30. da ida 15 Battery TUR AED ODO ION AAA AA A A AA aana baa ARA 15 HOW INE Chane Ine Dat a cis 15 EU A cea ga BNN cat a ga pad ga ah A eae naba ga a ag T NAN ng 17 ON LOS aaa a ana fata kaa Sh tals Da a ta Seas Sid ad na aa Sg dn tele ea aed ad agak aapa na ag Sak ah abang anan ad tet 16 Running the Power On Se lt Test POST sia agan ga gada aan a ees aia 18 AWOME SEN CSE aaa et lalate Sas r da il naga baa ag a naba a ga La a A toate alas 18 Self test when the Batteries are InSerted cccccocccoccnncccononccooooonnonnnnnnnonononnnnnnnonononnnnnnnnnnnnannnennnnnnns 19 AED OPERATION crac 21 AHA 2010 guidelines for CPR and ECC uu ccccssssscscccccsccnneeeseccesesssseeeeeccssssssaeseeeecessesaaueaesecessssaanesseeeeses 21 Additional amendments to the AHA 2010 guidelines for CPR and ECC ooocccccccncncccconinccccnnnconononnnnnnos 21 ZOTOCPR GUIDELINES e a pian A 22 Pre OCHO toON ACION n ear E E E E A A A E 23 TUSA ED A o a 23 TEGNOHEART DIS operato ee ee ee E ee es ede et agak a ads 24 ARA 20 10 DIOVISIONS pra A AA AA AAA AA AA A acid 26 NOTES on NOWO Penn GER ter aaa 27 Notes on User and Bystander Safety anyone surrounding the rescuer and the patient 27 MAINTENANCE sia eiii 29 FACCV CHI ana ISDOS a nana 30 Returning INGAED and TON PS a ia 31 ASSISTANCE SD ec ER RO ESTAN RA ASA 31 PONOGIC SaIClY CNC E A A pc pale nga od ets 31 CLEANING e tas es athe Leech th ak ate eee Mb 31 YAA o ag aa a daga nas a a ab Ag tages ad naga aaa
31. e AED and its accessories for an y signs of physical damage Do not use the device if any damage is found Refer t o the Maintenance section for instructions on how to return damaged articles Mak e sure that potential users are duly trained Notes Check the accessories package to make sure the seals are intact and that the best before date is valid Parts List The following elements are included in the package as accessories Any optional ac cessories can be ordered as needed Refer to qualified assistance staff or your loca supplier for information on prices and the order Table 3 Accessories Standard Accessories contained in the package TECNOHEART plus AE001212 Optional Accessories must be ordered SD Card 2Gbytes 4 121240005 Software AED Event Review 0 1Z12A0006 Software AED Event Review User Guide 1Z12A0007 _ _Infrared communication adapter 1Z12A0008 Recommended Accessories can only be ordered with the KIT Qty A a Disposable Disposable gloves to protect the user to protect the user Disposable razor to shave the chest if hair makes good contact with the electrodes impossible Pocket mask or face protection to protect the user a An absorbent cloth or pad to dry the victim s skin for good electrode contact TECNO GAZ can provide a complete kit with all of the above accessories GAZ can TECNO GAZ can provide a complete kit with all of the above accessories a complete kit with all of th
32. e above accessories 1Z12A0009 11 Soft case A WARNING Do not use the AED on patients that react to stimuli or who are breathing normally e SD card The soft case is designed to stop the AED from moving inside the case using the device s handle The user can view the AED status indicator without having to open the case The contact information sheet for the nearest emergency medical services can be placed inside the transparent cover There is a pocket on the rear side of the soft case to store the manual and spare electrodes There are two more pockets on the right and left sides of the case to store spare batteries The SD card must be inserted into the SD card slot on the right of the AED panel as described below The SD card is used to save AED performance history and to update the device s firmware Performance history saved on the SD card can be accessed through the Software AED Event Review If you want to use the SD card to use the Software AED Event Review or to update the AED firmware contact qualified service personnel or your local supplier When the AED is on it can be switched off by closing the cover Open the cover of the SD card slot Put the SD card into the slot Close the cover of the SD card slot To update the AED from the SD card turn it on by moving the scrolling button to the right When the update is complete the device will switch off automatically Close the cover back up Se ak a O Infra
33. e it is necessary to order a new battery code 1 12A0002 Discharged missing or disconnected battery no electrical discharge possible If you hear the voice message saying Batteria scarica sostituire la batteria Battery discharged change the battery when the AED is on or in use the AED has 9 electrical shocks left If the last bar on the level reading is not visible the buzzer will sound twice and the device will switch off automatically Change the battery immediately 17 Before using the AED make sure that the AED is working correctly and that it is safe to use as described below AN WARNING If the self test is not carried out correctly do not attempt to use the AED ATTENTION When the power supply is connected the AED automatically runs the self test which checks the AED circuits and functions As the Power On Self Test POST is running make sure that the AED status indicator is on If the AED status indicator is not working correctly do not use the AED Rather seek the assistance of qualified personnel or your local supplier Running the Power On Self Test POST 1 Turn the AED on from the Scrolling switch open the door 2 The AED will automatically run the Power On Self Test POST 3 If the AED detects any problems during POST the status indicator will display X Contact qualified assistance staff or your local supplier for assistance 4 Once you have run the POST correctly the AED will play
34. e patient s bare chest Figure 7 TECNOHEART plus Action icon Step 1 24 Adult Paediatric over 8 years of age over 25 kg in weight between 1 and 8 years of age weight up to 25 kg Figure 8 Positioning the Electrodes If the electrodes are not connected the device will play the following voice message e Connettere gli elettrodi Inserire saldamente il connettore Connect the electrodes Firmly attach the connector Figure 9 TECNOHEART plus Electrode disconnection icon Notes If the electrode connector is not connected at any step the AED will switch to the Electrode disconnection icon and the device will play a voice message saying Connettere gli elettrodi Inserire saldamente il connettore Connect the electrodes Firmly attach the connector If the electrodes are applied correctly to the patient as shown in the figure 8 the device will play the following voice message e Analisi del ritmo cardiaco Non toccare il paziente Heartbeat analysis Do not touch the patient e Scarica consigliata Carica Non toccare il paziente Shock recommended Shock Do not touch the patient or e Analisi del ritmo cardiaco Non toccare il paziente Heartbeat analysis Do not touch the patient e Scarica non consigliata Shock not recommended Figure 10 TECNOHEART plus Action icon Step 2 Notes If the voice message plays Scarica non consigliata Shock not recommended the AED wi
35. emoved from the Open the airways check for CPR sequence to check for breathing once the airways have breathing been opened in the 2010 guidelines The 2010 guidelines If the user is not a medical recommend however that the medical attendant briefly checks attendant it is possible to breathing during the check of the response to detect signs of eliminate the check for breathing cardiac arrest step once the airways have been opened Perform CPR until an AED is available or until an emergency medical attendant arrives Notes 2 ventilations have been eliminated from the sequence it is recommended to continue with chest compressions 30 Compressions 2 Breaths i 30 2 UNTIL RESCUERS ARRIVE If an AED is available turn it in and follow the instructions DECIDE WHETHER TO DELIVER THE SHOCK YES NO 1 DELIVER THE SHOCK 1 Continue CPR for approximately 5 cycles Repeat every 2 minutes approximately 2 minutes 22 Pre defibrillation Action Before using the AED it is necessary to run the following controls and actions in order to prepare the patient e Remove any clothing and expose the bare chest e lf the chest is excessively hairy shave the area where the electrodes must be applied e Make sure the patient s chest is dry When necessary dry the area Turn the AED on A A WARNING Paediatric mode must be used on patients who are between 1 and 8 years of age or who weigh les
36. f led herein can cause an increase in emissions and or reduction in AED im munity The AED is suitable for use in the specified electromagnetic environment The customer an d or user of the AED must ensure that the device is used in an electromagnetic environme nt as described below Table 5 Electromagnetic emissions IEC60601 1 2 Conformity Electromagnetic Environment RF Emissions The AED must transmit electromagnetic CISPR 11 energy in order to perform its function Any nearby electronic equipment may be affected RF Emissions Class B The AED is suitable for use in any CISPR 11 business Table 6 Electromagnetic Immunity IEC60601 1 2 Immunity Test IEC60601 1 2 T Level of Conf Guide to the Electromag est Level ormity netic Environment Electrostatic kV contact 6 kV contact discharge ESD 8 kV air IEC 61000 4 2 Magnetic field network frequency 50 Hz IEC 61000 4 8 The floor must be wood cement or ceramic tiles If the floor is covered with a synthetic material the relative humidity must be at least 30 It may be necessary to place the AED far away from magnetic field sources with a supply frequency or install a magnetic shield Any magnetic field with a supply frequency must be measured in the place of installation to ensure that it is low enough Notes UV is the d c network voltage before applying the test level 45 Table 7 Electromagnetic Immunity 1EC60601 1 2 c
37. h of at least 5 cm in adults 26 The rescuers perform 5 cycles of CPR each cycle is comprised of 30 chest compressions and 2 rescue breaths at intervals of 30 chest compressions every 2 minutes Or perform the chest compressions without rescue breaths The AED will stay in CPR mode for 2 minutes or 5 cycles After two minutes of CPR the device will play the following voice message e Interrompere la RCP Stop performing CPR The AED will go back to Step 6 which analyses the ECG and repeats this procedure Make sure that no one touches the patient and proceed like before Follow these instructions until the emergency healthcare provider arrives then hand the patient over to them Notes on how to perform CPR As you are performing CPR Observe and listen to the AED it will play Iniziare la RCP Start CPR and the action icon will start to flash at a frequency of 100 times per minute making a sound every time the action icon flashes It is necessary to perform chest compressions at a depth of more than 5 cm at a frequency of 100 120 beats per minute according to AHA guidelines Notes The user must be trained in the pre selected SCA treatment In any case follow the voice messages and the visual instructions provided by the AED Notes on User and Bystander Safety anyone surrounding the rescuer and the patient A WARNING Make sure that no one touches the patient before pressing the Shock button Say Stand clear
38. her companies with the exception of products delivered by TECNO GAZ e Damage caused by unsuitable and or improper use is the responsibility of the user e The use of parts for maintenance that are not recommended by TECNO GAZ for repairs and maintenance e Changes to the device or the use of accessories that are not specifically recommended by TECNO GAZ e Damage caused by accidents or natural calamities earthquakes floods etc e Damage due to the failure to observe the warnings and instructions for use set forth in this manual e Damage due to the failure to observe the recommended maintenance checks e This warranty only covers parts The warranty does not cover the following cases e Any damage or leaks due to the connection or operation of accessories e In case of product defects we ask that you contact our sales point or the EU representative as stated on the back cover e TECNOHEART plus complies with EMC standard IEC60601 1 2 Notes Use near mobile phones could cause faulty function of the AED History of the Revisions The document part number and the revision number identify the current version The revision number changes when a new version is printed in compliance with the history of the revisions of the documentation The revision number does not change with minor corrections and updates that are added in the re prints The number for the document part changes when considerable technical changes are added Factory Bra
39. iction of the use of Hazardous Substances in electrical and electronic equipment II Directive on battery disposal Battery directive Quality systems Medical Devices Requisites for Regulation Purposes Application of medical device risk management General regulations for the safety of electro medical devices Protection Rating provided by the Casing Waterproof rating IP54 Clinical assessment of Medical Devices for human subjects part 1 General requirements Human factor engineering guidelines and preferred practices for the design of medical devices Software for medical devices Software life cycle processes Electromedical devices Parts 1 6 General requirements for basic safety and essential performance Collateral standard Usability Medical devices Application of usability engineering to medical devices Electromedical device parts 1 9 General requirements for the basic safety and essential performance Collateral standard Requirements for environmentally conscious design Biological assessment of Medical devices Part 1 Assessment and test 42 Ambulance Defibrillator EMC Packaging Reliability Labelling Marking ISO 10993 5 2009 EN ISO 10993 5 2009 ISO 10993 10 2010 EN ISO 10993 10 2010 EN 1789 2007 A1 2010 EN 13718 1 2008 RTCA DO 160G IEC 60601 2 4 2010 EN 60601 2 4 2011 AAMI EC57 1998 R 2008 IEC 60601 1 2 2007 EN 60601 1 2 2007 IEC 61000 4 2 2008 EN 6
40. ll switch to step 4 which illustrates the CPR process Notes The AED performs Step 2 as soon as it is powered on after the rescuer has correctly connected the electrodes to the patient Moreover if the electrodes are connected to the patient Step 2 will start even if the AED is still in Step 1 This can reduce electrical shock preparation time for trained rescuers Notes Follow the voice commands Do not touch the patient or allow others to touch him her during AED analysis When the analysis is finished the AED will suggest the recommended treatment To keep the patient still you will need to pay particular attention A moving patient could lead to a diagnosis and accordingly an incorrect delayed or less effective treatment 25 e Premere ora il pulsante di Scarica Erogare la scarica ora Press the Shock button now Deliver the charge now e Scarica erogata Shock delivered or pulsante di Scarica non premuto Shock button not pressed Figure 11 TECNOHEART plus Action Icon Step 3 Notes The AED will only deliver a shock if necessary A voice message will tell you when to press the Shock button to administer the defibrillation therapy ll paziente pu essere toccato in sicurezza It is safe to touch the patient Iniziare la RCP Start CPR or Se necessario Iniziare la RCP if necessary start CPR e Fare due respirazioni Perform two breaths e Ripetere 2 3 5 volte Repeat 2 3
41. make sure that the AED is working correctly A WARNING To reduce the risk of electric shock do not attempt to remove the cover for any reason No parts can be replaced by the operator and any work carried out on the AED can only be performed by a qualified technician If the AED detects an error the status indicator will read X Contact qualified service personnel or your local supplier Before contacting qualified staff or your local supplier make sure you have observed the ambient conditions set forth in the manual such as temperature humidity altitude et cetera Corrective Measures Check the expiration date of the electrodes Change the electrodes if they have reached their expiration date Check the expiration date and the duration of the battery life in standby Change the battery if it has reached its expiration date or its battery life in standby Below is a list of possible errors and suggestions for corrective measures If the status indicator does not yet read X or if you hear a warning message when the AED is on or if for any reason you suspect that the AED is not working correctly contact qualified staff or your local supplier or TECNO GAZ directly to receive assistance info TECNO GAZ co kr 1 There is no response when the cover of the AED is opened e One of the CPU modules may not be working Inform qualified staff or your local supplier to check and replace the CPU module e The battery may not
42. n to provide the replacement date of the electrodes and batteries 8 Disposal of old electrodes 31 AED Maintenance TECNO GAZ advises users to perform periodic checks A recommended maintenance check could be 1 O O1 Checking the status indicator If the status indicator reads xX this means it has detected a problem Consult the troubleshooting section herein Check the expiration date of the electrodes If the electrodes have reached their expiration date remove and change them Contact qualified assistance staff or your local supplier to replace them singe Patient Use Only 43 C 109 4 F Latex Free ac 32 F LOT 2 Figure 13 Electrode expiration date Check the AED and its accessories for any damage or the expiration date Change any damaged or expired accessories Check for any cracking or other signs of damage to the exterior of the AED In case of damage contact qualified staff or your local supplier Make sure that the trained user is informed of the location of the AED and that it is easily accessible to Rescuers at any time Make sure that all trained users have received updated training on CPR techniques and AED operation Consult the designated organisation or agency for their recommended refresher course schedules 32 TROUBLESHOOTING A WARNING If you are not sure that the measurements are accurate check the patient s vital signs using other methods then
43. nd It is likely that the trade names of the product provided herein are brands or registered brands of the involved company CONTENTS INA SA e ag a ab ka cana eue a A ag aa i SAFETY WARNINGS iaa 1 General Sale WANNI sasasi tidal ceed daana odas 1 WV ATMOS sasapan api a A E E aa a aga a A E apan ada 1 A O aaa teenie teen ery aia a oe ein te Reet eerie A 3 INTRODUC HON ica rs 5 mendea USO INES AED sss frases sss sage se Kaja eee pines eee ese E 5 IT OMMAH ONION ANC WV QIN asics sears Mal easie Saale aba aa a aa ngana raab an a aaa E aa aa a aaa aes 6 Identifying the AED Configurations is 6 DESCRIPTION OF THE AED di T Fans ote TOp and RIOT FaN li A E AAA E AS 7 EN A A 8 SVIMOOIS ANG EGON 3 A A A A Gives a Ga 9 CONFIGURING THE AED airada 11 Bajera ori ag ba ag aaa ater kaa aka tnd ka Ek elds Ate E iad asta ahi abe aaa teeta 11 NS A A ere ee eee 11 A Ce eee EE A ee ne ee ee eee ee eee rr 12 A hacia hace ie Saline nid a Nga NG a Bak njala Tan a E aa pad bees eee Seco aan 12 InfrareG COMIMUMICAUON DO saa aan set AA AA A DIA ces E NA A a a a ag A 12 CONNGOTINOANCAED saa Sites Si agan abaan aan et Solr ce aa dairies aapa na na aga aan aa aid adana a begah Aan 13 TOMIPCTAUUIC SlalUS avi ie aa abaan A ga aa a pa aa aa a aa sak ak a aa gd ah aan E 13 WISA al On SCD Lt AS AAA na gada a A ANA AA a ia a 14 STANDS TODD a AAA NG an IA Gi GG A a aa E a cad 14 IASTAUAUON SIOP A asia kaka abnag an a NA a a A A ad a na aaa ci 14 BATTERY OPERATION cuida
44. ng the following operations 1 Use AED Event Review Software to download information on the treatment that was carried out and store it accordingly If you do not possess the AED Event Review Software contact your supplier to download it 2 Remove the electrodes used by the AED and dispose of them accordingly For suitable disposal methods consult the section on recycling and disposal 3 Check for any cracking or other signs of damage to the exterior of the AED Immediately contact your supplier or TECNO GAZ technical support in case of damage 29 4 Check for dirt or contamination on the exterior of the AED If necessary clean the AED with authorised cleaning products 5 Check the expiration date or damage to the equipment accessories and spare parts Replace them immediately if they are damaged or if the expiration date is up Contact your local authorised TECNO GAZ dealer 6 Install new electrodes or batteries Before installing new electrodes check the expiration date 7 After the new battery has been installed Check the status indicator If the status indicator does not read O consult the troubleshooting section herein If the problem persists contact your local authorised dealer for technical support 8 Turn the AED on and make sure it is working correctly for example make sure it plays the Unita ok Unit ok voice message Turn the AED off 9 Contact TECNO GAZ after use It is important for us to
45. ning electrodes with this AED ATTENTION Be particularly careful with patients with pacemakers To determine whether there is a pacemaker it is necessary to run a physical exam and study the patient s medical history In patients with pacemakers the AED could have less sensitivity and may not detect all of the rhythms required for defibrillation ATTENTION If the electrodes adhere well to the patient s chest the AED can analyse the precise ECG and avoid burns to the skin If however the electrodes overlap on the patient s chest they will not deliver the defibrillation energy correctly INTRODUCTION TECNO GAZ offers a completely configurable AED designed to actuate the suitable protocol in case of sudden cardiac arrest SCA The current AED is designed to operate in compliance with the 2010 version of the guidelines established by the AHA ERC regarding Cardiopulmonary Resuscitation CPR and Emergency Cardiovascular Care ECC It is recommended to be trained in the appropriate version of the AHA ERC guidelines and the use of your AED configuration For further information contact TECNO GAZ or your authorised TECNO GAZ distributor Intended use of the AED The AED is intended to be used to treat someone who is unresponsive non breathing and pulseless for the adult and pediatric in all area of a hospital pre hospital public access alternate care and home healthcare environment AED is designed to easy to use Note The intended pa
46. nsmitter outp 80 MHz to 800 MHz 800 MHz to 2 5GHz ut power in watt d 1 2 pP d 2 3wWP For transmitters with maximum output powers that are not listed above the recommended separation distance d in metres m can be calculated using the equation that applies to the transmitter frequency where P is the maximum transmitter output power coefficient in watt W according to the manufacturer of the transmitter Notes At 80MHz and 800MHz a higher frequency range is applied to the separation distance Notes These indications may not be applicable in every situation Electromagnetic propagation is affected by its absorption and reflection by structures objects and people Table 9 Cables IEC60601 1 2 Maxi Cables and Sensors a ee Compliant with Length RF Emissions CISPR 11 Class B Group 1 Electrostatic Discharge ESD IEC 61000 4 Electrode cables 1 8 m 2 Radiated RF IEC 61000 4 3 Magnetic Field Frequency IEC 61000 4 8 47 A Str Cavalli 4 43038 Sala Baganza PR ITALIA EU representative OBELIS S A Bd G n ral Wahis 53 1030 Brussels Belgium Manufacturer geal Mediana Co Ltd 132 Donghwagongdan ro Munmak eup Wonju si Gangwon do Korea Tel 82 2 542 3375 82 33 742 5400 Fax 82 2 542 7447 82 33 742 5483 Copyright 2013 All rights reserved
47. ontinued from previous page Immunity IEC60601 Test Test Level Guide to the electromagnetic environment The AED is suitable for use in the magnetic environment specified below The customer or user of the AED must ensure that the device is used in said environment Radiated RF 3V m 10 V m 20 IEC 61000 4 3 V m 80 MHz 1 GHz 1 GHZ 2 5 GHz These values are required for compliance with directive IEC60601 2 4 Portable and mobile RF communication devices must be used at a distance from any part of the AED including its cables The minimum recommended distance is calculated based on the equation that applies to the transmitter frequency Recommended separation distance d 1 2 VP 80 MHz at 800 MHz d 2 3 VP 800 MHz at 2 5 GHz Where P is the maximum transmitter output power coefficient in watt W according to the manufacturer of the transmitter and dis the recommended separation distance in metres m The field intensities of the fixed RF transmitters detected by on site electromagnetic surveys must be lower than the conformity level in each frequency range There may be interference near devices identified by the following symbol ce Notes Maximum admissible frequencies between 80 MHz and 800MHz Notes These indications may not be applicable in every situation Electromagnetic propagation is affected by its absorption and reflection by structures objects and people It is not theoreti
48. r solvents ATTENTION Follow the local statutory laws and recycling laws on disposal or recycling parts of the AED including the batteries ATTENTION Do not place the battery in short circuit as this may generate heat To avoid short circuits never place the battery terminal in contact with metal objects especially during transport ATTENTION Never weld the battery directly The heat applied during welding can damage the safety relief valve on the cover over the battery positive pole ATTENTION Do not deform the battery by applying pressure Do not throw strike drop bend or hit the battery ATTENTION Do not use the battery with batteries by other manufacturers of other types or models such as dry batteries nickel metal hybrid batteries or Li ion batteries as they may lose electrolytes and heat or explode ATTENTION Treat the battery with care and do not use it in applications that are not recommended by TECNO GAZ ATTENTION Keep the battery out of the reach of children to avoid accidents ATTENTION If there are any problems with the battery immediately place it in a safe place and contact qualified staff or your supplier ATTENTION The batteries must be changed and the electrodes must be positioned in the ambient conditions described herein If the AED is commissioned outside of the range of the ambient conditions it will not operate correctly After using the AED TECNO GAZ technical support recommends performi
49. red communication port Infrared communication port provides wireless communications from the AED to a PC through the Infrared communication data download cable and IR communication adaptor which is connected to PC Use the infra red communication to update the firmware to transfer information and to connect to service mode If you want to use the communications port contact qualified personnel or your local supplier Infra red communication adapter Code 1212A0008 12 Configuring the AED A WARNING Only use parts accessories optional parts materials and components that are approved and specified by TECNO GAZ The use of unauthorised accessories can cause the device to fail and provide false readings Follow all of the instructions provided on the defibrillation electrode and battery labels AN WARNINGS Always follow the in situ infection control procedures and the applicable regulations for the disposal of everything that was used on patients A ATTENTION Do not open the electrode package until use when they are applied to the patient Temperature status The temperature conditions entail the following descriptions e f the self test is run outside of the ambient operating conditions more than 5 times the status indicator will read x e When the AED with a status indicator reading of O is switched on outside of the ambient operating conditions range Notes When the AED screen provides a reading of X an
50. rements interruptions in operation or other malfunctions If this should happen inspect the area to determine the source of the disturbance Perform the following actions to attempt to eliminate any malfunctions e Turn the nearby devices off and back on again to identify the interfering device e Redirect or reposition the interfering device e Increase the distance between the interfering device and the affected device The AED generates uses and can release radio frequency energy If the AED is not installed and used in compliance with these instructions the AED can cause harmful interference with other nearby devices If you require assistance contact qualified staff or your local supplier Obtaining Technical Assistance To receive information and assistance or to order the AED maintenance manual contact your local supplier The maintenance manual provides the necessary information to qualified staff or your local dealer on AED maintenance For technical assistance please contact the store that invoiced the device or contact us directly at TECNO GAZ S P A Tel 39 0521 8380 Fax 39 0521 833391 MEDILINE ITALIA S r l Tel 39 0522 942997 Fax 39 0522 944800 e mail service tecnogaz com 34 GLOSSARY Sudden Cardiac Arrest SCA Sudden cardiac arrest is a condition in which the heart suddenly stops pumping efficiently due to an electrical malfunction of the heart Often the victims of SCA do not present
51. ring a shock it is important to disconnect the patient from other electrical medical equipment such as blood flow meters that may not be equipped with protection from defibrillators Also make sure that the electrodes are not touching metal objects such as bed frames or tensioners ATTENTION Only remove the protective film from the cartridge when you are ready to use the electrodes ATTENTION Do not use or activate the AED before reading the Operator Manual for the AED ATTENTION Do not use the AED or connect it to other equipment If the AED is used with or connected to other equipment check operation carefully prior to use ATTENTION Treating or transporting the patient during the ECG analysis could cause interference with the diagnostic process which could prolong analysis times If the AED reads SCARICA CONSIGLIATA SHOCK RECOMMENDED during treatment or transport stop the device and keep the patient as still as possible for at least 15 seconds before pressing the Scarica shock button so that the AED can re confirm the analysis of the heartbeat ATTENTION It is necessary to perform periodic checks on this device to ensure among other things that the AED is not damaged in any way ATTENTION The electrodes are a single use accessory and must be replaced after every use or if the electrodes are broken compromised in any way If you suspect any damage the electrodes need to be replaced immediately ATTENTION Do not use trai
52. rolling button to the right or to the left depending on whether it is an adult or paediatric patient 2 Turn the AED on by moving the Scrolling button to the right and opening the cover making sure that it is possible to hear the voice messages e Unita ok unit ok e Elettrodi adulti adult electrodes or Elettrodi pediatrici paediatric electrodes 3 Make sure that the status indicator reading of O is clearly visible 4 Turn the AED off by closing the cover 5 Close the Cover making sure to position the defibrillation electrodes inside the AED Notes When you change the AED battery the self test will run automatically When the self test is over make sure you hear the voice message saying Unita ok unit ok and make sure the AED is off Installation step 3 Put the AED back in its Soft Case Installation step 4 Place the AED in an attended safe and visible location Notes The location storage specifications are not the same in different countries Seek the assistance of qualified personnel or your local supplier The AED must be kept in an easily accessible location Place the device near a telephone so that the rescuer can call the emergency medical services and get the AED without wasting any time Some important points for storage Store the AED in a position that is easy to access Do not lock the selected storage area for the AED with a key Store the AED in a clean dry place Inst
53. s than 25 kg 55lb WARNING If the electrodes are not applied correctly the AED may cause damage to the patient To place the electrodes in the correct positions follow the voice messages and the action icons If the electrodes are not set up correctly the treatment will not work or the electric shock will burn the patient s skin WARNING Do not position the electrodes near the generator of an internal pacemaker The analysis of a patient s heat beat with an implanted pacemaker could be inexact or the pacemaker could be damaged by the discharge of the defibrillator WARNING Do not perform chest compressions CPR on the electrodes These actions could damage the electrodes and cause the AED to malfunction WARNING Always apply the electrodes to smooth areas of skin Avoid applying the electrodes to skin folds such as those below the breasts or on obese patients If there is excessive hair poor adhesion or air bubbles between the skin and the electrodes this may cause burning or inefficient transfer of energy WARNING To apply the electrodes to the patients chest correctly if necessary shave the application area WARNING Always check the expiration date of the electrodes and do not use the electrodes if the packages have previously been opened If the excessively dry pads are attached AED may interpret as a condition that the pads are not attached to the patient WARNING Touching the patient during the treatment
54. sertion self test is finished 16 Battery Status Reading The new battery life is provided as set forth below Storage life in the original package 2 years from the production date if stored and maintained according to the methods described in the operator manual Battery life in standby installed in the AED 5 years from the production date if stored and maintained according to the methods described in the operator manual Discharged A minimum of 200 electrical shocks not counting the CPR period between the defibrillation treatment or 10 hours of operation at an ambient temperature of 20 C TECNO GAZ suggests replacing the used battery even if it has only been used once Notes After 200 electrical shocks a voice message will play Low battery insert fresh battery Battery discharged change the battery Notes Due to the physical measurements of the battery compartment it is necessary to use batteries supplied by TECNO GAZ only Using other types of spare batteries may damage the AED and cause the limited warranty to lapse When you are working on the batteries the battery status reading reports the battery level See Table 4 Table 4 Battery Status Icon Battery Status Icons Battery Status m Fully charged battery it is possible to perform lt 200 electrical shocks or 10 hours of operation defibrillation Battery In standard use Used battery lt 9 electrical shocks
55. supplier to check it Battery Maintenance The battery life of the new battery can be at least 10 hours of monitoring or 200 shocks excluding the CPR period between treatment and defibrillation or the combination of both A battery in standby mode installed in the AED has an average life of 5 years from the date of manufacture If the battery status indicator displays one bar it may be necessary to change the battery If the battery is not installed in the AED the battery life will end on its expiration date 2 years from the date of manufacture For a diagnosis of the reason why the status indicator reading is an X consult the troubleshooting section Electrode Maintenance The electrodes must be replaced if e They have reached their expiration date e When the electrodes have been used they are disposable and need to be replaced e The package of new electrodes has been previously damaged e The electrodes have been exposed to the air Replacing ui Electrodes Take the new electrodes out of their protective package 2 Disconnect the electrode connector from the AED 3 Firmly press on the electrodes to make sure they are inserted all the way in 4 Turnthe AED on 5 Check the status indicator If the electrodes have been inserted correctly the Status indicator will read O after approximately 6 seconds 6 If necessary inform the designated AED safety or maintenance staff 7 Update the pertinent informatio
56. t ok voice message the status indicator will display O and the AED will automatically switch off If the battery insertion self test is not completed correctly the AED will play the following voice message Unita non funzionante unit not operating and the status indicator will display X If the AED is not working correctly do not use it Rather seek the assistance of qualified personnel or your local supplier It is also possible to skip the battery insertion self test through the following procedure e Closed skip by opening the cover e Open skip by pressing the shock button When you have completed this procedure the AED will run the power on self test exactly as it does when the user turns the AED on Notes The self test is not capable of determining whether the battery and the electrodes connected to the AED have expired Remember to check the expiration date of the electrodes and battery life in standby on a regular basis 19 20 AED OPERATION WARNING Do not use the AED on patients that react to stimuli or who are breathing normally gt WARNING Do not use the electrodes if the gel is dry or damaged WARNING Before defibrillation disconnect the patient from other medical equipment WARNING Never lift the AED by the electrode cable or any other accessory These accessories could detach from the AED making it fall onto the patient gt bb ATTENTION Aggressive or extended CPR on
57. the AED can cause death or injury WARNING DO NOT USE OR ACTIVATE THE AED IF THE STATUS INDICATOR READS X WARNING Keep the batteries dry and away from sources of heat including direct sunlight If there is any visible damage or loss prevent the liquid from coming into contact with your skin or eyes If there has been contact rinse the affected part abundantly with water and immediately seek medical attention WARNING The AED is equipped with an automatic device to deactivate accumulated energy If the operator has not released the energy on the patient an internal timer will deactivate the accumulated energy Accumulated energy can cause death or injury if discharged improperly Follow the instructions provided herein Attention gt gt gt gt gt gt gt gt gt gt gt A Situations of alert are marked by the ATTENTION symbol illustrated above Attention signs identify conditions or actions that could cause damage to the equipment or to property ATTENTION The AED may not operate correctly if it is activated or stored in conditions that differ from those set forth herein ATTENTION The AED is resistant and reliable in various conditions of use Nonetheless an overly aggressive AED treatment can cause damage to the unit or the accessories causing the warranty to lapse Check the AED and its accessories for any damage on a regular basis and based on the instructions ATTENTION Before delive
58. the right Elettrodi pediatrici Paediatric electrodes If the electrodes are not connected the device will play the following voice message e Connettere gli elettrodi di defibrillazione Inserire saldamente il connettore Connect the defibrillation electrodes Attach the connector firmly AQ Adult Pediatric over 8 years old 1 8 years old or over 25kg less than 25kg Figure 6 Patient mode switch Notes The patient mode can be changed even as the procedure is under way If the patient mode is changed the AED plays this voice message Adult pads or Pediatric pads Return to ECG analysis while analyzing ECG or delivering electric shock even though the patient mode is changed during process When the patient mode is changed during CPR the AED will not emit the voice prompt 7 Make sure that the AED is powered on accordingly up to 6 and follow the voice messages and action icons The red LED under the respective action icon will flash TECNOHEART plus operation Remove any clothing to expose the patient s chest If the patient s chest is excessively hairy shave the area where the electrodes will be applied e Rimuovere i vestiti dal petto del paziente Posizionare gli elettrodi esattamente come indicato nella figura Premere forte gli elettrodi sul petto nudo del paziente Remove any clothing from the patient s chest Place the electrodes exactly as illustrated in the figure Press the electrodes firmly onto th
59. this voice message Unita ok unit ok and the status indicator will display O 5 Turn the AED off by closing the cover Automatic Self test The AED is programmed to run an automatic self test on a daily basis The self test will run automatically and does not require user control When an error is detected the status indicator displays X The self test tests the AED and makes sure that the basic functions are running properly e Daily self test MCU and Memory Integrity RAM ROM Battery capacity ECG algorithm analysis e Weekly self test Low energy waveform circuit test 2J ECG circuit test in addition to the daily self test e Monthly self test High energy waveform circuit test 504 in addition to the monthly self test Notes When the battery is low the status indicator displays X The battery status indicator also displays X when the battery is changed Seek the assistance of qualified personnel or your local supplier Notes The self test is not capable of determining whether the battery and the electrodes connected to the AED have expired Remember to check the expiration date of the electrodes and battery life in standby on a regular basis 18 Self test when the Batteries are Inserted When the battery is installed or changed the AED automatically runs the battery insertion self test Once the battery insertion self test is complete the AED will play the Unita ok uni
60. through the heart first in one direction then the other Biphasic Truncated Exponential BTE waveform The Biphasic Truncated Exponential BTE waveform stands for Self Compensating Output Pulse Envelope Pad The pads are the electrodes that are applied to the patient s chest in order to administer the therapy Electromagnetic Interference Electromagnetic interference is radio interference that could cause defective operation of the electronic devices Impedance Measurement Impedance measurement is a control that is carried out to check the integrity of the contact between AED and patient 35 Defibrillation Reading The electrical rhythm of cardiac muscle contractions can be detected and used for the medical diagnosis and reading called Electrocardiogram ECG The AED is designed to analyse the patient s ECG so as to detect ventricular fibrillation VF of the heart If ventricular fibrillation VF is detected the AED delivers an electric shock accurately designed to interrupt any chaotic electrical activity in the heart muscle during SCA This can permit the victim s heart to return to a normal sinus rhythm TECNOHEART plus The AED is a semi automatic device used to provide external defibrillation therapy to resuscitate unconscious SCA victims who are not breathing or are unresponsive AED Event Review Software AED Event Review Software is a software that can be used with the AED and with the SD card or with the C
61. tient populations are adult and pediatric 1 8 years old or less than 25 kg 55lb can be treated with the appropriate pads Note If you have concerns about your health or an existing medical condition talk t o your doctor A defibrillator is not a replacement for seeking medical care Where can it be used The intended environment to use the AED includes home healthcare public space and hospital The public space is a social space that is generally open and accessible to people Roads including the pavement public squares parks subway station government buildings beaches public libraries privately owned buildings or property opened to public visible from sidewalks and any shared spaces of automobiles and other vehicles are typically considered public space Hospital use typically includes areas such as general care floors operating rooms special procedure areas intensive and critical care areas within the hospital Hospital type facilities include physician office based facilities sleep labs skilled nursing facilities surgical centers and sub acute care centers Who can use it You cannot use the AED to treat yourself The AED talks the user through each step of treating someone who is in SCA However anyone who might use the AED should review the training materials that come with it or contact your local authorized supplier or Medical technical support and should be trained in cardiopulmonary resuscitation CPR Responding to
62. tteries accumulators contained in it can be collected separately from other waste at the end of their service life In particular the separate waste collection of this device when it reaches the end of its service life is organised and managed a directly by the user if he she decides to dispose of the device without replacing it with a new identical one with the same functions b by the manufacturer considered as the body that originally introduced and marketed the device in Italy or that resells in Italy under its own trade name the new device replacing the previous one if the user decides to dispose of the device at the end of its service life and purchase an equivalent product with the same functions at the same time In the latter case the user can ask the manufacturer to pick up the current device strictly within 15 consecutive calendar days from the date of delivery of the new device In terms of the batteries accumulators the user is required to take these products to suitable separate waste collection centres set up by the competent authorities at the end of their service life Suitable separate waste collection with the aim of having the device and its batteries accumulators decommissioned for recycling treatment and disposal in an environmentally friendly manner contributes to avoiding possible negative effects on the environment and health and promotes the reuse and or recycling of the materials that these parts are composed
63. xclusively on the measurements provided by the AED for your assessment of the patient WARNING It is possible that any device designed for radio frequency transmission and other nearby sources of electrical disturbance can cause interruptions in AED operation WARNING It is possible although improbable that the use of power on off relay switches can cause the AED to malfunction Do not use the AED with electrocauterising or diathermic devices or in similar environments This AED was tested and has been proven to be compliant with the standards required for medical devices by IEC60601 1 2 and by Directive 93 42 EEC regarding medical devices These limits are established to provide suitable protection against any harmful interference in traditional medical facilities Nonetheless due to the proliferation of devices that transmit radio frequencies and other sources of electrical interference in hospital facilities electro surgical devices mobile phones two way mobile radios electrical devices and HD television sets high levels of this interference due to the excessive vicinity or intensity of a source can cause an interruption in AED operation WARNING The AED is designed for use in environments where the signal can be affected by electromagnetic interference During such interference the measurements may be inexact or it may seem that the AED is not working correctly Defective AED operation can be illustrated by irregular measu

User Manual Defibrillator - Tecno-Gaz

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