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Instramed EazyPro, User Manual

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Instramed EazyPro User Manual Download Page 47

User manual | 

Operating Soft DEA

47

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Summary of Contents for EazyPro

Page 1: ...User manual AUTOMATED EXTERNAL DEFIBRILLATOR WITH MANUAL FUNCTION ...

Page 2: ...erations made in the device attempts of repair not provided by authorized technical assistance centers operation by unqualified personnel use of defective device or use of accessories and parts not supplied by the manufacturer For information about warranty or technical assistance please contact Instramed s technical support Copyright 2017 Instramed The Eazy PRO Instramed and its respective logos ...

Page 3: ...ent for more than 20 days it is advisable to execute a full battery charge If this procedure is not performed there is a risk of draining the battery and consequently being unable to use the Eazy PRO in its portable configuration not connected to the electric current Replacement Every battery has a determined shelf life which is the possible quantity of full charge and discharge cycles without los...

Page 4: ...pads One first aid kit containing 1 pair of surgical gloves 1 scissor and 1 CPR mask A transport bag A USB cable CD with instructions manual and SOFTDEA management PC software Optional Item A pair of disposable child size adhesive pads Replacement parts You can ask Instramed for replacements of the following items consult Instramed for prices Shipping costs may be applied Batteries replacement Adu...

Page 5: ... 11 Safety Information 12 Warnings 12 Adverse effects 14 Standards 14 Device care 14 Cleaning and disinfection 15 Connection to other equipment 15 Disposing of the device 16 Precautions 16 Classification and Symbols 17 The Equipment 18 Front Panel 18 1 Touch screen 19 2 Operational status indicator 21 3 Start button 23 ...

Page 6: ...sable pads compartment 25 6 Disposable pads connector 26 7 Cabinet recess 26 Operating in AED mode 27 Step 1 28 Step 2 29 Step 3 30 Step 4 31 Step 5 31 Simplified diagram of procedure in adults 32 Operating in manual mode 34 Step 1 35 Step 2 36 Step 3 37 Step 4 38 Step 5 38 Simplified diagram of procedure in adults 39 Applying CPR 41 ...

Page 7: ...tion 45 Connecting the Eazy PRO to a PC 45 Operating SoftDEA 46 Startup screen 46 1 Graphic display button 46 Graphic display screen 47 1 Download 47 2 Open 47 3 Print 48 4 PDF 48 5 Amplitude selection 48 6 Time frame 48 7 Time frame scroll 48 8 Amplitude scroll 48 9 Event viewer window 48 Adjustments 50 1 Update clock 50 2 Volume level 50 Changing languages 51 ...

Page 8: ... Equipment with life support functions 56 ECG analysis algorithm 58 Types of arrhythmia analyzed 60 Specifications 61 General specifications 61 Environmental specifications 62 Defibrillator 63 Precision of applied energy 64 Patient s impedance response table 64 ECG rhythm recognition and detector table 64 Alarm system 67 Information signals 68 Inspection and maintenance 70 Preventive Maintenance 7...

Page 9: ...ent contrast and visualization area the user selects the operation mode and charge while visualizing the ECG curve The interface is simple and self explanatory Characteristics Semi automated Artificial Intelligence accurate diagnosis of the patient s conditions indicating shock delivery or not Safety precautions prevents accidental use in cases in which shock treatment is not advisable or in healt...

Page 10: ...esponse is almost always positive Therefore the most important factor in survival is how fast treatment is delivered Ideally treatment should not be delayed for more than four minutes from the beginning of the defibrillation Principle Defibrillation is the electrical shock therapy responsible for reversing cardiac arrest caused by ventricular fibrillation or ventricular tachycardia without a pulse...

Page 11: ...llation Hypothermic patients may not respond well to defibrillation Once the removal of the patient is started the defibrillation must be interrupted Qualified users Shall be considered qualified users those who have had training in a recognized institution in the use of automated defibrillators and CPR techniques Cardiopulmonary Resuscitation About the manual The function of this guide is to expl...

Page 12: ...UCT IS PORTABLE BUT INSTRAMED DOES NOT RECOMMEND ITS USE IN AMBULANCES WARNING EAZY PRO CAN BE USED BY PATIENTS OVER 01 ONE YEAR OLD REGARDLESS OF THEIR WEIGHT WARNING THE PATIENT MUST BE PLACED ON NON CONDUCTIVE SURFACES DO NOT USE WET OR METALLIC SURFACES AND IF NECESSARY DRY THE CHEST BEFORE APPLYING THE SHOCK WARNING DO NOT TOUCH THE PATIENT THE EQUIPMENT THE ACCESSORIES NOR ANY METALLIC OR CO...

Page 13: ...CESSORIES AND ANY OTHER COMPONENTS MUST BE DISPOSED OF ACCORDING TO THE NORMS OF HOSPITAL WASTE DISPOSAL NOTICE DO NOT MODIFY THIS EQUIPMENT WITHOUT AUTHORIZATION FROM INSTRAMED ATTENTION THE ADHESIVE PADS CANNOT BE IN CONTACT WITH THE PATIENT WHILE EAZY PRO IS CONNECTED TO THE AC DC EXTERNAL SOURCE THE PADS SHOULD NOT BE PLACED ON THE PATIENT WHILE EAZY PRO IS CONNECTED TO THE MAINS VIA ITS AC DC...

Page 14: ...6 Medical Electrical Equipment Part 1 6 General requirements for basic safety Collateral Standard Usability NBR IEC 60601 1 8 Medical electrical equipment Part 1 8 General requirements for basic safety and essential performance Collateral standards General requirements testes and guidance for alarm systems in medical electrical equipment and medical electrical systems NBR IEC 60601 2 4 Medical ele...

Page 15: ...Do not use strong solvents containing acetone or that are enzymatic Do not spill liquid of any kind on any part of the equipment ATTENTION NEVER sterilize any part of the equipment and its accessories through the sterilization by heat method as for example using autoclave This process would damage the mechanical structure and would compromise the equipment working The above recommendations ensure ...

Page 16: ...2002 96 CE Precautions Danger of EXPLOSION Do not use the Eazy PRO in the presence of flammable anesthetics Risk of ELECTRICAL SHOCK Never open the equipment When necessary this must be done by authorized individuals Do not use the equipment in the presence of magnetic resonance devices This equipment was designed to be resistant to electromagnetic interference However equipment performance can be...

Page 17: ...SO 7000 ISO 780 Minimum and maximum temperature ISO 7000 Minimum and maximum atmospheric pressure ISO 7000 Minimum and maximum relative humidity IEC TR 60878 Recyclable paper Directive 2002 96 CE Remains of electrical and electronic equipment Dispose of separately from other disposables Directive 93 42 EEC Mark of conformity according to the European Community XXXX stands for the number of the cer...

Page 18: ...information and allows for manual interaction with the device 2 Operational status indicator 3 Start button On the next pages you will find the detailed description of each component of the front panel AUTOMATED EXTERNAL DEFIBRILLATOR AED MANUAL OVERRIDE FUNCTION 1 2 3 ...

Page 19: ...tems on the screen when connected to the patient Analyzing Do not touch the patient CPR 00 00 BPM 080 1 2 3 4 5 6 7 1 Heart beats per minute 2 Manual mode button 3 Orientation message 4 ECG curve 5 CPR interval counter counts the interval between discharge delivery helping in the CPR Cardiopulmonary resuscitation massage 6 Icon indicating the defibrillation stage 7 Battery status ...

Page 20: ...will be the user s entire responsibility Charge Charge Cancel CPR 00 00 BPM 080 1 3 6 7 5 8 9 4 2 1 Heart beats per minute 2 Charge selector allows the user to select the desired energy charge 3 Selected charge 4 ECG curve 5 Automatic mode button 6 Charge button charges the defibrillator to the selected energy setting 7 CPR interval counter in manual mode this indicator shows the continuous counti...

Page 21: ... has another internal defect Charge battery immediately If the indicator remains red please call technical assistance Shows that the device is operating and ready for use Mains supply LED on means device is connected to the electric current Mains supply LED blinking when in normal use means the battery needs charging In this state the Eazy PRO guarantees at least 3 full energy discharges Battery L...

Page 22: ...ch can be identified by the user from a distance and can also be interpreted according to the frequency as in the table below Number of beeps Failure description Two CPU failure Three Failure in defibrillation module Four Discharged battery ATTENTION the device will not switch on if the battery is discharged or showing general failure In this case only the sound warning of the respective failure w...

Page 23: ... clinical analysis of the patient indicates the need for it More information in the Operation section NOTE it is not necessary to switch the Eazy PRO off Fifteen seconds after the removal of pads from the patient or disconnection of pads from the equipment the device switches itself off saving battery charge In this moment the follow ing message will be heard The device is being turned off Press t...

Page 24: ...ser manual The Equipment 24 Sides 1 Speaker 2 Battery power supply connector 3 Battery compartment 4 USB connector 5 Disposable pads compartment 6 Disposable pads connector 7 Cabinet recess 1 4 6 7 5 2 3 ...

Page 25: ... to charge the internal battery The power supply operates on voltage between 100 to 240 V in 50 60 Hz ATTENTION the device performs internal routine verifications which consume energy Even when the equipment is not in use a full charge is recommended every 20 days 3 Battery compartment It holds the internal batteries of the equipment The reset button is also placed in this compartment in case rest...

Page 26: ...disposable pads to the Eazy PRO ATTENTION whenever the pads set is replaced remember to keep a new pair already connected to the equipment 7 Cabinet recess Used for attaching the cord of the disposable pads to the equipment s body preventing the cord from getting loose When installing a new pair of pads push the connector s cord in its narrowest part inside the cabinet recess and then twist to fix...

Page 27: ...PRO operates Be sure to carefully memorize the detailed guide on the next pages before operating the equipment Start Início 3 2 4 1 5 6 Place pads on patient Equipment analyzes patient s condition Analysis is concluded shock is recommended Press button to deliver shock Press button to start cycle Shock delivered start CPR cardiopulmonary resuscitation The energy delivered is preadjusted The user c...

Page 28: ...nnector to the plug on the right side of the equipment After disposing of used pads always leave a replacement pair already connected to the equipment avoiding having to replace them at the mo ment of the emergency ATTENTION this device has electronic safeguards and will not operate in inadvisable situations Check patient s condition Only use the equipment if the patient is not breathing ...

Page 29: ...g the whole thoracic cage ATTENTION the area in contact with the pads must be dry The presence of too much hair in the contact area may affect scanning In this case shave hair ATTENTION the pads must be applied directly over the skin DO NOT place pads over clothes ATTENTION The pads are disposable and for single use cannot be reused under any circumstances ATTENTION After opening the wrapping the ...

Page 30: ...at the user can perfectly understand them Visual indications in each stage will also be demonstrated on an LCD screen ATTENTION the patient must be on a steady surface Any movement during the process of clinical analysis will result in mistaken scans ATTENTION the pads are disposable and can be used in only one patient at a time Remember to always keep extra ones with the equipment For replacement...

Page 31: ...ith him her during shock delivery under risk of suffering a powerful electric discharge ATTENTION disconnect other equipment which do not have defibrillation protection before defibrillating the patient If clinical scans show that defibrillation is not recommended the Eazy PRO will announce TREATMENT NOT RECOMMENDED Check whether there were patient s movements during the analysis If there were res...

Page 32: ...le CPR for 2 minutes No pulse no breathing recovery Shock recommended Shock delivered Check patient s condition Place victim on a dry flat and steady area The Eazy PRO analyzes patient s condition Shock NOT recommended Move away from the patient Activate AED CPR for 2 minutes Wait for emergency team Wait for emergency team Place pads Activate the Eazy PRO Simplified diagram of procedure in adults ...

Page 33: ...patient s condition Shock NOT recommended CPR for 2 minutes It doesn t recover breath and or movements Shock recommended Move away from the patient Activate AED Shock applied CPR for 2 minutes Wait for emergency team Wait for emergency team Wait for emergency team Conscious Panting It recovers breath and or movements Simplified diagram of procedure in adults User without a degree in medicine with ...

Page 34: ...the mode change the Eazy PRO ceases to emit sound and visual orientation in addition to the automatic safeguards against shocks Press button to start cycle Press button to deliver shock Place pads on patient Shock delivered Start CPR Cardiopulmonary Resuscitation Activate manual mode Select charge and charge energy ATTENTION The use of the manual mode is the user s entire responsibil ity The use b...

Page 35: ...onnector to the plug on the right side of the equipment After disposing of used pads always leave a replacement pair already connected to the equipment avoiding having to replace them at the mo ment of the emergency ATTENTION this device has electronic safeguards and will not operate in inadvisable situations Check patient s condition Only use the equipment if the patient is not breathing ...

Page 36: ...ing the whole thoracic cage ATTENTION the area in contact with the pads must be dry The presence of too much hair in the contact area may affect scanning In this case shave hair ATTENTION the pads must be applied directly over the skin DO NOT place pads over clothes ATTENTION The pads are disposable and for single use cannot be reused under any circumstances ATTENTION After opening the wrapping th...

Page 37: ...NUAL button on the device s screen Confirm this choice on the following screen The Eazy PRO will switch to manual mode Follow the instructions Place pads on the patient Do you confirm switch to Manual Mode Yes No If the user does not confirm the switch in 5 seconds the device will return to automatic mode ...

Page 38: ...ck will be delivered ATTENTION the user must not touch the patient or conductive surfaces in contact with him her during the shock delivery under risk of suffering a powerful electric discharge ATTENTION disconnect other equipment which do not have defibrillation protection before defibrillating the patient Step 5 After the shock start the CPR procedure See more in section 6 applying CPR ...

Page 39: ...ycle CPR for 2 minutes No pulse no breathing recovery Shock recommended Shock delivered Check patient s condition Place victim on a dry flat and steady area The Eazy PRO analyzes patient s condition Shock NOT recommended Move away from the patient Activate AED CPR for 2 minutes Wait for emergency team Wait for emergency team Place pads Activate the Eazy PRO Simplified diagram of procedure in adult...

Page 40: ...s patient s condition Shock NOT recommended CPR for 2 minutes It doesn t recover breath and or movements Shock recommended Move away from the patient Activate AED Shock applied CPR for 2 minutes Wait for emergency team Wait for emergency team Wait for emergency team Conscious Panting It recovers breath and or movements Simplified diagram of procedure in adults User without a degree in medicine wit...

Page 41: ...ach 3 Keep two fingers right below this point 4 Place the palm of your other hand above the two fingers that indicate the base of the Sternum bone This is the correct spot for the massage 5 Put one palm on top of the other keeping your fingers curled up without touching the thorax In small children however use only your fingers Apply force according to the victim s size 6 Keep your arms stretched ...

Page 42: ... mouth to mouth breathing check if the patient s pulse is back The massage and ventilation cycle must be done for two minutes If the patient s pulse does not return restart shock procedure with the Eazy PRO After the third complete CPR and shock cycle chances of the patient s resuscitation are very slim ATTENTION the CPR techniques shown in this manual are only refer ential and do not substitute t...

Page 43: ...However on patients from one year of age to eight years of age or patients who weigh less than 25kg some precautions must be taken Use child pads If the pads cannot be placed within the minimal distance of 4 centimeters between them place one of them on the child s chest and another on his back Shorter than 4 cm Chest Back Larger than 4 cm ...

Page 44: ...e firmware version of the equipment only for authorized technicians Requirements Connecting the Eazy PRO to a PC requires installation of the SoftDEA application in the computer to which a connection will be made This software is in the CD which comes with the equipment To install SoftDEA observe the following requirements Windows XP Windows Vista or Windows 7 operating system CPU of 300 MHz or fa...

Page 45: ...e drivers to be installed will be required They can be found in this folder C Program Files Instramed SoftDEA DRIVERS Start the SoftDEA application On the language selection screen choose among Spanish English or Portuguese You only have to select a language the first time you start the software After the software reads the Eazy PRO data see following section the ECG and the events list will appea...

Page 46: ...tartup screen 1 1 Graphic display button Click this button to display the ECG waveforms and event list stored on the device The displayed interval corresponds to the user defined time frame see item 7 on page 47 of this manual ...

Page 47: ...set of information that is currently being viewed can be saved on the PC by clicking this button A window will open enabling the user to select the desired location in which to store the file 2 Open Click this button to open a dea file that was previously saved on the computer download open ...

Page 48: ...e selection Allows the user to vary the ECG amplitude from 0 5 mV to 3 0 mV 6 Time frame Allows the ECG to be viewed in time frames from 1 second to 60 seconds 7 Time frame scroll Allows the ECG to be viewed throughout its time scale 8 Amplitude scroll Allows the ECG to be viewed throughout its amplitude scale 9 Event viewer window After downloading the information contained in the CardioMax memor...

Page 49: ...ventricular fibrillation or ventricular tachycardia pattern SHOCK NOT INDICATED Shock not indicated on account of the electrocardiogram pattern not requiring a shock ANALYZING AED Analyzing heart rhythm ASYSTOLE Asystole detected PADS DISCONNECTED The pads were disconnected CHILD PADS Child pads were connected to the device ADULT PADS Adult pads were connected to the device TURNED ON The equipment...

Page 50: ...the equipment In order to make changes the Eazy Eazy PRO device must be turned on and connected to the PC running SoftDEA via the supplied USB cable 1 Update clock Click the update button to synchronize the clock with the time on the PC connected to the Eazy Eazy PRO device 2 Volume level Using the mouse simply select one of the five volume presets for the equipment audio update ...

Page 51: ...ompts emitted by the speaker on the device to the selected language Under the in the device option when a CardioMax device is connected The CardioMax language can be changed through the device s settings menu see page 48 General setup However if the voice prompts emitted by the CardioMax device show signs of degradation or defects this function can be used to restore the equipment s speech synthes...

Page 52: ...User manual Operating Soft DEA 52 2 Exit Click this button to close SoftDEA 3 ...

Page 53: ...in this manual Mobile and portable RF communications equipment such as a cellphones may affect the functioning of the Eazy PRO Maximum length of accessory cables in order to comply with the requirements of Electromagnetic Compatibility is 2 5 m All parts and accessories listed below follow the requirements for Electromagnetic compatibility Pair of disposable adhesive pads adult size Pair of dispos...

Page 54: ...ss its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions ABNT NBR IEC CISPR11 Class B The Eazy PRO is suited for use in any establishment This includes residential establishments and those directly connected to the public network of distribution of low voltage electricity which supply domestic use buildings Harmonics Emissions IEC 61...

Page 55: ...e IEC 61000 4 5 1 kV differential mode phase phase 2 kV common mode phase ground 1 kV differential mode phase phase 2 kV common mode phase ground The quality of the power supply should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cyc...

Page 56: ...plied NOTE 2 These directives may not be applicable in all situations Electromagnetic transmission is affected by the absorption and reflection of structures objects and people a ISM bands industrial medical and scientific between 150kHz and 80MHz are 6 765MHz to 6 795MHz 13 553Mhz to 13 567MHz 26 957MHz to 27 283MHz and 40 66MHz to 40 70MHz b The compliance levels in the ISM frequency bands betwe...

Page 57: ...38 3 8 7 3 100 35 120 12 23 For transmitters with a maximum output power not listed above the advisable separation distance d in meters m can be determined by using the equation applicable to the frequency of the transmitter where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80MHz and 800MHz the separation distance for the highest ...

Page 58: ...port Recording Methods the files were acquired via internet through the MIT BIH database and used via computer ECG Rhythm Sources MIT BIH on http ecg mit edu Rhythm Selection Criteria rhythms were chosen according to notes present in the MIT BIH database Criteria and Annotation Methods the rhythms were recognized and annotated in a separate file Later they were recognized and compared for sensitiv...

Page 59: ...urement units to correctly identify a shockable rhythm A false positive B is the equipment s ability in measurement units to wrongly recognize a shockable rhythm A false negative C is the equipment s ability in measurement units to wrongly recognize a nonshockable rhythm A true positive D is the equipment s ability in measurement units to correctly recognize a nonshockable rhythm Values measured w...

Page 60: ... with Extrasystoles Sinus Rhythm with Pacemaker Asystole Shockable Ventricular Tachycardia with several QRS amplitudes and widenings Ventricular Fibrillation with several amplitudes Rhythm Classes Specifications Shock VF The Eazy PRO meets IEC 60601 2 4 requirements for sensitivity 90 Shock VT The Eazy PRO meets IEC 60601 2 4 requirements for sensitivity 75 Nonshockable rhythms The Eazy PRO meets ...

Page 61: ...arge the battery when fully depleted 5 hours Battery power supply charger AC 100 240 V 50 60 Hz Consumption maximum Electric mains supply 1A Output 24 VDC 1 5 A Battery storage Storing the battery for a long period of time in temperatures higher than 35 C 95 F will reduce its capacity and shelf life Pre adjusted defibrillation scales Adults 1st shock 150J next shocks 200J Child 50 J Internal memor...

Page 62: ...hod from Mains Power Supply Flexible cable with a mains plug Non frequent use equipment Comply with the requirements for non frequent use equipment as specified in NBR IEC 60601 2 4 standard Environmental specifications Temperature Operational 0 to 50ºC 32 to 122 ºF Storage 0 to 70 ºC 32 to 158ºF Humidity Operational 10 to 95 RH without condensation Storage 10 to 95 RH without condensation Altitud...

Page 63: ...ection Automatic due to the size of the pads Charge command Automatic after identifying arrhythmias that should receive shock Shock command Front panel button when blinking Maximum time from rhythm analysis beginning to discharge readiness 20s The rhythm detector and recognizer does not continue analyzing ECG after a shockable rhythm is detected Maximum charging time 50 Joules 2 seconds 150 Joules...

Page 64: ...91 5 201 5 205 5 206 0 203 5 192 0 177 0 15 Patient s impedance response table Patient s impedance Shock Short circuit Shock inhibited 25 Ohms Shock inhibited 25 Ohms e 300 Ohms Shock delivered with a waveform adjusted to the patient s impedance 300 Ohms Shock inhibited Open circuit Shock inhibited ECG rhythm recognition and detector table VF and VT All other ECG rhythms Shock indicated 329 23 No ...

Page 65: ...l Specifications 65 Values on the Y axis refer to voltage volts and values on the X axis refer to time milliseconds 200J of energy at 25R impedance 200J of energy at 50R impedance 200J of energy at 75R impedance ...

Page 66: ...User manual Specifications 66 200J of energy at 100R impedance 200J of energy at 125R impedance 200J of energy at 150R impedance ...

Page 67: ...RIORITY High VISUAL ALARM SIGNAL Button blinks in red at 2Hz and at a 50 duty cycle VERBAL ALARM SIGNAL Voice indication with the following text push the flashing button to treat the patient SOUND LEVEL Configurable between 65 and 85 dB A through PC software application SOFTDEA ALARM SIGNAL GENERATION DELAY Lower than 5s OPERATOR S POSITION The operator must be facing the front side of the device ...

Page 68: ...es In the manual mode reports the time elapsed since the device entered the manual mode Illustrative picture of the current step of the AED procedure AED mode only Picture that indicates to operator which stage of the automatic procedure the equipment is performing at the moment Battery Level Indicator Indicates the approximate device s battery level Energy Selected manual mode only Indicates the ...

Page 69: ...CPR for two minutes Treatment recommended don t touch the patient Treatment is not recommended Put the paddles on the patient s chest Energy is being discharged internally Problem with the automatic test Don t touch the patient The machine is turning off Press the button in order to turn the machine back on Charging complete Children s paddles Treatment succesful USB connected Give two breaths Che...

Page 70: ...quipment s power supply charger cables and connectors in order to determine possible isolation or internal conductor ruptures Remember to check the status of the operational status indicator at least every 30 days see page 20 operational status indicator Corrective Maintenance If the equipment needs repair this can only be done by INSTRAMED or its authorized representative otherwise this Warranty ...

Page 71: ...ion to a power source use distinct from that described in the User manual or irregular working conditions Any attempt to violate adjust or repair this equipment by individuals not authorized by Instramed Indústria Médico Hospitalar Ltda will automatically invalidate this warranty This also applies in case of alterations made to this contract the fiscal receipt or to the equipment s serial number I...

Page 72: ...www instramed com br 55 51 3073 8200 AUTOMATED EXTERNAL DEFIBRILLATOR WITH MANUAL FUNCTION ...

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