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13 

 

 

 

Configuring the AED 

 

         

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. 

 

 

        

WARNINGS:  Always follow the in situ infection control procedures and  the 

  applicable regulations for the disposal of everything that was used on patients. 

 

        

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. 

 

 

If the self-test is run outside of the ambient operating conditions more than 5 times, 
the status indicator will read ‘X’. 

 

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’ and 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 “Unità 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. 

Summary of Contents for TECNOHEART plus

Page 1: ...Defibrillatore ENGLISH DAE User Manual 0Z12I0008_REV_2 15 06 2021 Defibrillator...

Page 2: ...p 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 Par...

Page 3: ...se of accessories that are not specifically recommended by TECNO GAZ Damage caused by accidents or natural calamities earthquakes floods etc Damage due to the failure to observe the warnings and instr...

Page 4: ...elf Test POST 18 Automatic Self test 18 Self test when the Batteries are Inserted 19 AED OPERATION 21 AHA 2010 guidelines for CPR and ECC 21 Additional amendments to the AHA 2010 guidelines for CPR an...

Page 5: ...electrodes 24 Figure 10 TECNOHEART plus Icon of Action Phase 2 25 Figure 11 DAE Icon of Action Phase 3 25 Figure 12 TECNOHEART plus Icon of Action Phase 4 26 Figure 13 Date of expiry of the electrode...

Page 6: ...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...

Page 7: ...lation 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 p...

Page 8: ...k 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...

Page 9: ...4...

Page 10: ...le 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...

Page 11: ...E001Z12 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 automat...

Page 12: ...7 1 2 3 DESCRIPTION OF THE AED Parts of the Top and Right Panel 10 2 1 7 Figure 1 TECNOHEART plus 4 5 6 8 7 9 Figure 2 TECNOHEART plus Parts of the Top and Right Panel...

Page 13: ...Patient mode switch 6 Shock Button 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 Pres...

Page 14: ...t altitude limits for transport storage Temperature status Ambient humidity limits for transport storage Latex free Ambient temperature limits for transport storage Best before date Fragile handle wit...

Page 15: ...10...

Page 16: ...package as accessories Any optional ac cessories can be ordered as needed Refer to qualified assistance staff or your loca l supplier for information on prices and the order Table 3 Accessories Standa...

Page 17: ...ed 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 1...

Page 18: ...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 o...

Page 19: ...ke sure you hear the voice message saying Unit 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 v...

Page 20: ...ately 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 th...

Page 21: ...g the hook as illustrated in the first figure of Figure 5 c 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 t...

Page 22: ...l 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 Wh...

Page 23: ...this voice message Unit 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 b...

Page 24: ...he 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 in...

Page 25: ...20...

Page 26: ...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 essentia...

Page 27: ...breathing If the user is not a medical attendant it is possible to eliminate the check for breathing step once the airways have been Notes Open the airways check for breathing was removed from the CP...

Page 28: ...odes 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 a...

Page 29: ...tach the connector firmly 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 pa...

Page 30: ...a consigliata Carica Non toccare il paziente Shock recommended Shock Do not touch the patient or Analisi del ritmo cardiaco Non toccare il paziente Heartbeat analysis Do not touch the patient Scarica...

Page 31: ...ep 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 rem...

Page 32: ...s 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 tre...

Page 33: ...28...

Page 34: ...form 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 batte...

Page 35: ...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...

Page 36: ...he 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 mo...

Page 37: ...o replace them Figure 13 Electrode expiration date 3 Check the AED and its accessories for any damage or the expiration date Change any damaged or expired accessories 4 Check for any cracking or other...

Page 38: ...y 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 One of the CPU modules may...

Page 39: ...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...

Page 40: ...al 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 ventricul...

Page 41: ...turn 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 unr...

Page 42: ...F greater than or equal to 200 V V T greater than or equal to 160 per min Connection to the connector Confirmation of the connection and emission of voice messages Filter Between 0 5 and 30 Hz Indicat...

Page 43: ...5 0 m s Hz Falling height 1m Between 100 Hz and 200 Hz 7 dB per octave Between 200 Hz and 2000 Hz 1 0 m s Hz Resistance to water and dust IP54 IEC60529 Storage in the delivery box Temperature Between...

Page 44: ...Humidity Between 5 and 95 RH Non condensing Battery Battery Type LiMnO2 Disposable Long lasting Primary Cell Voltage Capacity 15V 4200 mAh Expiration Date on the original package battery life in stand...

Page 45: ...tanc e Pulse ampl itude 1 ms Pulse amplitude 2 ms Energy Delivered J 25 3 3 3 1 195 50 4 7 4 1 190 75 6 7 4 7 185 100 8 3 5 9 195 125 9 7 6 7 190 150 11 3 7 9 185 175 11 7 8 7 180 Defibrillation for p...

Page 46: ...0 1254 6774 28249 Specificity 100 0 100 0 100 0 99 9 99 9 99 Database for ECG analysis From the official database of the AHA American Heart Association From the official database of MIT Massachusetts...

Page 47: ...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 Rati...

Page 48: ...ostatic 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 in...

Page 49: ...ed 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 200...

Page 50: ...SPR 11 Group 1 The AED must transmit electromagnetic energy in order to perform its function Any nearby electronic equipment may be affected RF Emissions CISPR 11 Class B The AED is suitable for use i...

Page 51: ...a must be lower than the conformity level in each frequency range b There may be interference near devices identified by the following symbol Notes Maximum admissible frequencies between 80 MHz and 8...

Page 52: ...0 73 1 1 2 2 3 10 3 8 7 3 100 12 23 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 a...

Page 53: ...Bd G n ral Wahis 53 1030 Brussels Belgium Manufacturer 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 Copyr...

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