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Tecno-gaz TECNOHEART plus, Руководство пользователя

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42 

 

 

 

Conformity 

 

Entry Standard 

Description 

Classificatio 
n 

Type of 
protection 

Operating 
mode 

Protection 
rating 

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 

Internal power supply (battery-powered) 

CF type - Applied parts 

Continuous 

 

IP54 (provided by the casing) 

General 

93/42/EEC as amended by 
2007/47/EC 

Directive on Medical Devices (class IIb) 

 

 

21CFR820 Federal 

Regulations 

Code 

2012/19/EU 

Waste of electric and electronic equipment 

 

2011/65/EU 

Restriction of the use of Hazardous Substances in 
electrical and electronic equipment II 

93/86/EEC 

Directive on battery disposal 

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 

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 

 

 

AAMI HE75:2009 

Human factor engineering guidelines and 
preferred practices for the design of medical 
devices 

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 

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 

 

Содержание TECNOHEART plus

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 9: ...4...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 15: ...10...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 25: ...20...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 33: ...28...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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