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2 Safety

SmartVap Vaporizer SW 1.n, Instructions for use (en-US)

21

2.4

Warnings in these instructions for use

Warning words highlight safety-relevant information.
In the Instructions for use, warning words are used for actions that could lead to the endan-
germent of people or damage to the device.

A warning contains information about a possible hazard and instructions on how to avoid the
hazard.
Warnings are divided into different hazard levels, depending on the degree of the danger.

WARNING

Denotes a hazard with a medium degree of risk.
Failure to observe this warning can lead to severe, irreversible or
fatal injuries.

CAUTION

Denotes a hazard with a low degree of risk.
Failure to observe this warning can lead to minor or moderate in-
juries.

IMPORTANT

Denotes a harmful situation.
Failure to observe this warning can lead to damage to the device.

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Summary of Contents for SmartVap D

Page 1: ...Instructions for use SmartVapTM D SmartVapTM S SW 1 n...

Page 2: ......

Page 3: ...SmartVap Vaporizer SW 1 n Instructions for use en US 3 Page intentionally left blank...

Page 4: ...e letters in parentheses in the text refer to illustrations i Additional information is available 1 Numerals bold print in illustrations designate elements to which reference is made in the text 1 Num...

Page 5: ...2 2 1 4 Integrated emergency power supply 13 2 1 5 Use of volatile anaesthetics 14 2 1 6 Transportation 14 2 1 7 Devices required for using the vaporizer 14 2 1 8 Before every use 15 2 1 9 Device malf...

Page 6: ...2 2 Confirming the changed value 43 4 3 Changing parameters 44 4 3 1 Changing a value or an entry 44 4 3 2 Confirming a value or entry 45 4 4 Starting a function 46 5 Operation 47 5 1 Before first use...

Page 7: ...ion 77 7 4 8 Downloading the event log data 78 7 5 Expanded device information and settings menu 80 7 5 1 Opening the menu 80 7 5 2 Overview of options 81 7 5 3 Setting the minimum alarm volume 82 7 5...

Page 8: ...placing the emergency battery 113 11 2 6 Further maintenance work 114 11 3 Repairs 114 12 Shipping a vaporizer 115 13 Disposal 116 13 1 Disposing of the vaporizer 116 13 2 Disposing of the emergency b...

Page 9: ...e fresh gas flow and a dosing unit for enriching the fresh gas with Desflurane vapor according to the set concentration The fresh gas from the anaesthesia workstation can be enriched with gaseous Desf...

Page 10: ...dication s accompanying documents 1 5 Place of use The vaporizer is intended for stationary use in hospitals and rooms used for medical pur poses WARNING Risk of fire Only operate the vaporizer in are...

Page 11: ...ructions for use en US 11 WARNING Risk to patient from device malfunctions resulting from incor rect ambient conditions Only operate the vaporizer in accordance with the tempera ture humidity and pres...

Page 12: ...se instructions for use in an accessible place 2 1 2 Symbols and product labels If the symbols and product labels are not heeded this may put the patient and other per sons at risk or damage to the de...

Page 13: ...power supply fails during operating mode an alarm message will be displayed and battery operation will be automatically activated If the vaporizer is not used to dispense anaesthetic agent and the pow...

Page 14: ...s can pose a risk to persons If the patient s ventilation tube system has to be removed halt the delivery of volatile anaesthetic Fill the reservoir as described in chapter 5 5 Drain the reservoir as...

Page 15: ...th EN ISO 80601 2 13 If the instructions for use of the connected devices or device combinations are not followed before putting the devices into service this may result in risk to the patient and oth...

Page 16: ...ing of the patient The simultaneous use of an additional anaesthesia gas could lead to an overdose of vola tile anaesthetic and thus pose a risk to the patient Do not feed an additional volatile anaes...

Page 17: ...to the vaporizer may only be performed by the manufacturer or by technical personnel expressly authorized by the manufacturer 2 1 14 Accessories The vaporizer has been tested using accessories from th...

Page 18: ...on e g cell phones or medical electrical devices such as defibrillators or electrosurgical devices are used too close to the vaporizer the functioning of the vaporizer may be impaired by electromagnet...

Page 19: ...pur poses 2 1 18 Maintenance The vaporizer must be serviced regularly and correctly Otherwise malfunctions could oc cur resulting in risk to the patient and other persons or damage to the device Perf...

Page 20: ...fresh gas flow of the anaesthesia workstation changes in the supply of anaesthesia gas The following safety functions are integrated in the vaporizer to warn the operator if the pa tient is at risk De...

Page 21: ...ion about a possible hazard and instructions on how to avoid the hazard Warnings are divided into different hazard levels depending on the degree of the danger WARNING Denotes a hazard with a medium d...

Page 22: ...rtVap S Mechanical lock and interlock system compatible with anaesthesia workstations using the plug in adapter system and the Selectatec interlock system The mechanical lock guarantees correct positi...

Page 23: ...selection setting and confirmation Illuminated ring green rotary light dispensing of Desflurane active Illuminated ring off no dispensing of Desflurane Illuminated ring flashing blue pressing or turni...

Page 24: ...al locking 4 USB interface to export consumption data and event log files and to conduct SW updates 5 Mains power supply connection with cable protection Interlock system function Fig Right vaporizer...

Page 25: ...erface to export consumption data and event log files and to conduct SW updates 5 Mains power supply connection with cable protection Interlock system function Fig Right vaporizer 2 in operation left...

Page 26: ...device test or the status during the device test e g status messages error messages prompts to take action 3 Bottom bar Buttons and display areas 3a Button for starting Menu mode white selectable whe...

Page 27: ...ombined display area buttons Display of the currently set dispensing quantity and setting of the desired dispensing quantity Symbol if present Mechanical lock open Symbol if present Vaporizer blocked...

Page 28: ...Main screen Dialog area with display areas and buttons Depending on the topic of the dialog Buttons for switching to other dialogs Display areas with information about the device and its parts Buttons...

Page 29: ...tructions for use Caution Pay attention to the accompanying documents CE marking with the number of the manufacturer s notified body 0044 RWT V e V Authorization Agency for Device Safety Elevators and...

Page 30: ...19 EC Information about disposal The device must not be disposed of in regu lar household waste USB port back panel of the vaporizer Power supply input back panel of the vaporizer Lock symbol for the...

Page 31: ...r pressure limit Relative air humidity limit Temperature limit storage transportation Protect from sunlight Protect from moisture Fragile handle with care Limit value for stacking 2 Transportation lab...

Page 32: ...02008 91 SV S P Application identifier AI Every UDI number can be divided into multiple parts and each part is identified by its AI number 01 Global Trade Item Number GTIN 11 Date of manufacture YYYYM...

Page 33: ...3 3 6 2 Symbols on the screen Top bar Screen during device test The device test is active or a software update is performed An error has occurred Something has failed or malfunctioned Device test succ...

Page 34: ...bar Operating screen Menu mode can be activated Menu mode blocked Fill level here full Fill level almost empty Fill level empty Battery charge level 70 to 100 Battery charge level 40 to 70 Battery ch...

Page 35: ...nstructions for use en US 35 Mains power supply active Mains power supply disconnected Standby mode Screen in Menu mode Use case data Device information and settings Expanded device information and se...

Page 36: ...ting screen The vaporizer is blocked from use by the interlock The mechanical lock of the vaporizer is open Screen in Menu mode Device information Language Alarm volume Downloading of data case data e...

Page 37: ...e Software update Battery information Operating hours Consumption data Safety check USB drive Suitable USB drive found data export Suitable file found SW update USB drive No suitable file found SW upd...

Page 38: ...3 Description 38 SmartVap Vaporizer SW 1 n Instructions for use en US USB drive Data export USB drive Insufficient memory No mains power supply QR code links to additional information about the device...

Page 39: ...to the central control unit i e for warding of the signals to the display 1 Carrier gas fresh gas 10 Concentration selector 2 Vaporizer inlet 11 Desflurane reservoir 3 Carrier gas flow resistance 12...

Page 40: ...on is specified by the user by means of the concentration selector 10 and shown on the display 18 Depending on the selected Desflurane concentration and the carrier gas flow 1 that is measured the cen...

Page 41: ...urning knob By turning the knob settings are selected By pressing the turning knob briefly messages and settings are confirmed and functions are started By pressing the turning knob for a longer time...

Page 42: ...ct it by tapping on the combined display area button in the main section of the operating screen There are two ways to change the value of the dispensing quantity of Desflurane Option 1 Via the touchs...

Page 43: ...e dispensing quantity value must be confirmed within 5 seconds by pressing the turning knob 2 briefly After confirmation Desflurane at the set concentration will be dispensed into the fresh gas flow o...

Page 44: ...hen the dialog is opened a For dialogs with multiple parameters that can be changed the button for the first parameter from left will be automatically selected b To select a different parameter tap th...

Page 45: ...ces the value or moves to the entry below e g when changing the screen language 4 3 2 Confirming a value or entry If you tap the button for a parameter or if you change the value or entry for a select...

Page 46: ...has not found a USB drive prevent a function be ing carried out e g exporting to a USB drive the button will be surrounded by a white frame 2 to show that it is inactive To start a function tap the ac...

Page 47: ...t use To do this connect the vaporizer to the power supply and turn it on If necessary charge the emergency bat tery fully before the first use 5 2 Connecting to the mains power supply A Connect the p...

Page 48: ...ation with a connector panel for three vaporizers the middle posi tion on the connector panel must always be occupied by a va porizer in order to ensure that the interlock system is opera tive WARNING...

Page 49: ...zer in an upright position with both hands Place it carefully onto the con nector panel so that the plug connectors on the connector panel fit exactly into the openings in the vaporizer D Turn the loc...

Page 50: ...tus LED flashes on and a brief acoustic signal is emitted If required the vaporizer is heated up On the screen the user is informed of the progress of the device test and any errors B At the end of th...

Page 51: ...device test finishes successfully the illuminated ring around the turning knob flashes blue Briefly press the turning knob 1 The vaporizer changes to the operating screen i Additional information abou...

Page 52: ...underdosing of volatile anaesthetic result ing from a reduced dispensing quantity due to filling being per formed during the delivery of anaesthesia With a high dispensing quantity e g during uptake...

Page 53: ...he thread is reached D Turn the anaesthetic bottle 2 by another approximately 1 3 turn in a clockwise direc tion and hold The bottle valve is open and the Desflurane flows into the vaporizer reservoir...

Page 54: ...opening CAUTION Close the cover flap of the fill opening immediately after filling to avoid contaminating the fill opening with dirt particles and thus causing the valve to leak H Close the anaestheti...

Page 55: ...ation is not higher than 15 L min WARNING Risk to patient due to underdosing of volatile anaesthetic If the fresh gas flow in the anaesthesia workstation falls below the range specified for the vapori...

Page 56: ...fly pressing the turning knob 2 The illuminated ring around the turning knob shows a circling green point of light The dispensing of Desflurane into the fresh gas flow is initiated i Additional inform...

Page 57: ...will prompt the user to confirm the setting val ues above 12 0 Vol The illuminated ring around the turning knob 2 flashes blue B Confirm the message by briefly pressing the turning knob 2 The value s...

Page 58: ...The lower value can be set immediately and con firmed by pressing the turning knob i Additional information about setting the dispensing quantity can be found in chapter 4 2 5 8 Ending dispensing A Se...

Page 59: ...ng Standby dialog Prerequisite The vaporizer is in the operating screen and dispensing of Desflurane has ended There are two ways to open the Standby dialog Option 1 Via the touchscreen and Menu mode...

Page 60: ...andby in the Standby Cancel button 4 by tapping the Up arrow 5 or rotating the turning knob 3 in a clockwise direction The Standby Cancel button 4 will change color to blue B Confirm the change to Sta...

Page 61: ...rmation about the device test can be found in chapter 5 4 5 10 Removing the vaporizer from an anaesthesia workstation Prerequisite The vaporizer is in Standby mode A Turn the locking knob to the right...

Page 62: ...arm has an alarm message 2 and an alarm ID 3 The vaporizer distinguishes between alarms of high medium and low priority Priority Acoustic alarm Status LED High Ten tones repeated twice approx every fi...

Page 63: ...e cause of an alarm is rectified the alarm message will be disappear and the acoustic signal for this particular alarm will be silenced Please note Alarms and their alarm history are stored in the eve...

Page 64: ...press the turning knob 2 The acoustic alarm for all alarms is silenced for 120 seconds A timer is shown below the bell symbol When the timer elapses the alarm will sound again B To cancel Pause acoust...

Page 65: ...ill stop If the vaporizer is not being used for dispensing Desflurane at the time of the defect a medium priority alarm will sound WARNING Risk to patient due to underdosing of volatile anaesthetic In...

Page 66: ...acoustic alarm by pressing the turning knob for at least 5 seconds B Disconnect the vaporizer from the mains power supply C Turn off the flashing red status LEDs by pressing the turning knob again for...

Page 67: ...Standby dialog Device information and settings menu Device information dialog Screen language dialog Alarm volume dialog Brightness dialog Additional information dialog Data export dialog Expanded de...

Page 68: ...mple Operating screen A Tap on the Menu 1 button in the screen s bottom bar The Menu bar opens and the Case data dialog is displayed The Case data 3 button in the Menu bar is blue 2 Back button Return...

Page 69: ...ew of the menu options unlocked with the PIN Expanded settings Service 6 Standby button Opens a dialog for powering down the vaporizer Standby mode B End Menu mode by tapping on the Back 2 button or b...

Page 70: ...r failure no mains power supply and no power supply from the emergency battery the data is automatically reset The data is down loaded in the form of a text file Prerequisite To download the data a US...

Page 71: ...e indicated by a corresponding USB symbol 3 D Confirm the resetting of the data by briefly pressing the turning knob 5 The data is reset If a USB drive with sufficient memory is recognized the data wi...

Page 72: ...the options is displayed 7 4 2 Overview of options 1 Device information button Opens a dialog with information about the vaporizer 2 Screen language button Opens a dialog to set the screen language 3...

Page 73: ...ion dialog the following information about the vaporizer is shown Vaporizer type SW version Serial number A In the Options dialog of the Settings menu tap the Device information 1 button The Device in...

Page 74: ...played B Select the desired language from the choices available by tapping on the arrow buttons 3 or by turning the knob 4 The Language button 2 changes color to blue and displays a different language...

Page 75: ...ume dialog is displayed B Set the desired alarm volume by tapping on the arrow buttons 3 or by turning the knob 4 The Volume 2 button changes color to blue and displays the changed value C Confirm the...

Page 76: ...dialog is displayed B Set the desired brightness by tapping on the arrow buttons 3 or by turning the knob 4 The Brightness 2 button changes color to blue and displays the changed value C Confirm the c...

Page 77: ...l be shown By scanning the QR code the manufacturer s website containing additional information about the vaporizer will open up on the device used for scanning A In the Options dialog of the Settings...

Page 78: ...ries In the event of a complete power failure no mains power supply and no power supply by the emergency battery the data will be saved The data is downloaded in the form of a text file Prerequisite T...

Page 79: ...removed while downloading is taking place the vaporizer will abort the process D Close the dialog by tapping on the Back 6 button The menu s Options dialog is displayed Please note If the Data export...

Page 80: ...tart a Service mode A In the Menu bar of the User menu tap the Expanded 1 button The PIN entry dialog is displayed B The first PIN entry button 2 is selected Enter the first digit of the PIN by tappin...

Page 81: ...g to perform a software update 5 Battery information button Opens a dialog with information about the emergency battery 6 Operating hours button Opens a dialog with information about the number of ope...

Page 82: ...me dialog is displayed B Set the desired alarm volume by tapping on the arrow buttons 3 on the screen or by turning the knob 4 The Volume 2 button changes color to blue and displays the changed value...

Page 83: ...e UTC in a year month day format B Set the year by tapping on the arrow buttons 3 on the screen or by turning the knob 4 The Year button 2 changes color to blue and displays the changed value C Confir...

Page 84: ...Universal Time UTC in a 24 hour format B Set the hour by tapping on the arrow buttons 3 on the screen or by turning the knob 4 The Hour 2 button changes color to blue and displays the changed value C...

Page 85: ...7 3 IMPORTANT Damage to the device may be caused by a failure of the power supply during the software update Before performing the software update ensure that the vapo rizer is connected to the mains...

Page 86: ...n be closed by tapping on the Back 6 button C Start the software update by briefly pressing the turning knob 5 The software update is performed During the software update the vaporizer powers down bla...

Page 87: ...ollowing information about the emergency battery is shown Battery charge level Number of charging cycles Type Serial number A In the Options dialog of the Expanded menu tap the Battery information but...

Page 88: ...e Operating hours with therapy Total operating hours In the event of a complete power failure no mains power supply and no power supply by the emergency battery the data will be saved A In the Options...

Page 89: ...be saved The data is downloaded in the form of a text file Prerequisite To download the data a USB drive FAT32 formatted with sufficient memory must be connected i Additional information about connect...

Page 90: ...essing the turning knob 4 The data is reset If a USB drive with sufficient memory is recognized the data will be automatically downloaded D Close the dialog by tapping on the Back 5 button The menu s...

Page 91: ...n the Options dialog of the Expanded menu tap the Safety check button The Safety check dialog is displayed B In order to reset the interval for the next safety check tap the Reset 2 button The Reset 2...

Page 92: ...ID Alarm Pri ority ID Cause Remedial action Battery mal function 18 The emergency battery is defective The dispensing of anaes thetic agent is possible as long as the mains power supply does not fail...

Page 93: ...anaes thetic agent dispensed is lower than the set value this may occur when fill ing the reservoir or during battery operation for ex ample If the vaporizer is cur rently being filled stop filling Or...

Page 94: ...was opened To continue dispensing anaesthetic agent lock the vaporizer onto the connector panel of the anaesthesia workstation and restart the dispens ing of anaesthetic agent Or press the turning kno...

Page 95: ...ns power supply The charge level of the emergency battery is lower than 70 If the vaporizer is not used for dispensing an aesthetic agent it turns off after a short time Connect the vaporizer to the m...

Page 96: ...y mode and restart Additional information can be found in chapter 6 3 Technical error 100 A technical error has oc curred The dispensing of anaesthetic agent has been stopped A Continue sedation of th...

Page 97: ...t of a power supply failure the dis pensing of anaesthetic agent stops Device test Heating up Device test active The vaporizer heats up and conducts a self test Device test Turn the turning knob to co...

Page 98: ...device test Safety check Safety check due soon Press the turning knob to continue S001 The safety check for the vaporizer is due within the next 30 days To confirm the error message press the turning...

Page 99: ...al clock is defective the time and date settings can be lost In this case the user is prompted to set the date UTC and time UTC The setting is done in the same way as in the Time and Date dialogs in t...

Page 100: ...as soon as the dispensing quantity is increased above 12 0 Vol Additional information can be found in chapter 5 7 Close the mech lock and restart dispens ing DES Or press the turning knob to confirm...

Page 101: ...e found No suitable USB drive has been recog nized Software update Message Description Do not remove the USB drive Instruction during the update process Do not disconnect the mains power supply Instru...

Page 102: ...olume has been set too low Increase the volume Device information and set tings menu Alarm volume di alog see chapter 7 4 5 Screen too dark Brightness has been set too low Increase the screen brightne...

Page 103: ...mposition of the cleaning and disinfecting agents is the responsibility of the manufacturer of these agents and may change over time Active agent Active components Name Manufacturer Alcohol Bacillol 3...

Page 104: ...ing agents Follow the product information provided by the manufacturer of the cleaning and disinfecting agents Perform the cleaning as described CAUTION Risk to persons from contamination of the envir...

Page 105: ...tions for use en US 105 B Carry out wipe disinfection C Remove any disinfectant residue after the contact time D Allow the vaporizer to dry fully i Additional information about the outer materials of...

Page 106: ...der the cover flap of the fill opening Ensure proper ventilation of the premises while emptying CAUTION Risk to persons from incorrect handling storage and disposal of the volatile anaesthetic Emptied...

Page 107: ...ached E Turn the vaporizer over so that the anaesthetic bottle points vertically downward F Screw the anaesthetic bottle 2 approximately another 1 3 turn in a clockwise direction and hold The bottle v...

Page 108: ...e an aesthetic bottle while the vaporizer is upside down and the an aesthetic bottle points downward H Place the vaporizer in an upright position I Unscrew and remove the anaesthetic bottle by turning...

Page 109: ...eplacement of wearing parts and checking the func tioning of individual vaporizer components Repair Corrective measures to restore full functionality following failure of a device func tion 11 2 Maint...

Page 110: ...fety check Maintenance personnel or authorized service organiza tion Every 24 months Component Action Done by Emergency battery Replace Maintenance personnel or authorized service organiza tion When r...

Page 111: ...uct version The safety related labels markings are complete and legible The following vaporizer parts do not show any visible damage o Mechanical lock locking knob locking pin o Interlock pins SmartVa...

Page 112: ...safety test In this test the following parameters are tested in accordance with IEC 62353 2014 for D VDE 0751 Basis IEC 60601 class I B Earth leakage current pass 500 A Insulation resistance pass 10 M...

Page 113: ...ws 2 Battery compartment cover 3 Emergency battery A Undo the four screws 1 B Remove the battery compartment cover 2 C Carefully remove the old emergency battery 3 D Insert a new emergency battery E R...

Page 114: ...e done by a service organization authorized by the manufacturer i Additional information about further maintenance work can be found in the technical documentation for the vaporizer 11 3 Repairs To re...

Page 115: ...NG Risk to persons from volatile anaesthetic in the vaporizer Volatile anaesthetic may leak from the vaporizer and contaminate the environment Empty the vaporizer before shipment as described in chap...

Page 116: ...ronic equipment In order to properly dispose of the vaporizer ar range to return it by contacting the manufacturer or a manufacturer authorized service or ganization 13 2 Disposing of the emergency ba...

Page 117: ...2 m straight connection socket PC IT 002 UK length 2 m angled connection socket PC UK 001 US length 2 m straight connection socket PC US 002 CH length 2 m straight connection socket PC CH 002 ZA leng...

Page 118: ...g system Ambient conditions Operating mode Temperature range 18 to 30 C 64 to 86 F Atm pressure range 700 to 1100 hPa 10 2 to 16 psi Relative humidity 30 to 75 non condensing Ambient conditions Storag...

Page 119: ...ccordance with EN 60601 1 2 Class A Test parameters and threshold val ues can be obtained from the man ufacturer if needed UMDNS code 10 144 UDI DI GTIN codes SmartVap D 4260665920921 SmartVap S 42606...

Page 120: ...on Device Display Screen 3 5 touchscreen USB interface Type USB 3 0 type A Pneumatic interfaces to the an aesthesia workstation Back pressure 10 mbar to 80 mbar Flow resistance vaporizer 100 mbar 10 L...

Page 121: ...FGF medicated air Reservoir Range 0 to 550 mL Resolution 10 mL Use case data dispensing du ration Range 00 00 to 99 59 hh mm Resolution 1 minute Use case data consumption Range 0 to 9999 mL Resolutio...

Page 122: ...ical data 122 SmartVap Vaporizer SW 1 n Instructions for use en US For Values Safety check interval Range 0 to 365 days d Resolution 1 d Battery charge level Range 0 to 100 Display area 1 to 100 Resol...

Page 123: ...ndard setting 50 Brightness Range 50 to 100 Increments 10 Standard setting 100 Date and time UTC 15 4 Outer materials used Component Material Housing Aluminum alloy powder coated Glass front Glass Cov...

Page 124: ...rms and abbreviations 124 SmartVap Vaporizer SW 1 n Instructions for use en US 16 Terms and abbreviations In alphabetical order DES Desflurane FGF Fresh gas flow SW Software UTC Coordinated Universal...

Page 125: ...ed from the instructions for use SmartVap vaporizer SW 1 n Document ID No 046 10107 E The menu for the expanded settings is protected by this password to prevent unauthorized modification of the set t...

Page 126: ...17 PIN information 126 SmartVap Vaporizer SW 1 n Instructions for use en US...

Page 127: ...larm volume Date Time Software update Battery information Operating hours Consumption data Safety check The PIN can be found on the previous page of the instructions for use Cut out the section with t...

Page 128: ...128 SmartVap Vaporizer SW 1 n Instructions for use en US Notes...

Page 129: ...SmartVap Vaporizer SW 1 n Instructions for use en US 129 Notes...

Page 130: ...130 SmartVap Vaporizer SW 1 n m Instructions for use en US Notes...

Page 131: ......

Page 132: ...Tel 49 261 899 689 00 Fax 49 261 899 689 09 info tim gmbh de www tim gmbh de 0044 Distributed by www piramalcriticalcare com This document SmartVapTM Vaporizer Instructions for use en US ID No 046 10...

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