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Innomed Medical HeartScreen112 Clinic, User Manual

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Innomed Medical HeartScreen112 Clinic User Manual Download Page 62

HS112 C-1 User Manual 

62/73 

R-6730-EN02-E 

 

 

 
 

18.13. Communication parameters 

Communication 

USB 

Communication services (optional!) 

- online monitoring of 12 leads 

-ECG device control from PC 

-record creation and storage directly on the PC 

 

18.14. Mechanical (informative) data 

Size 

295 x 225 x 80 mm 

Weight (informative) 

1,9 kg 

Summary of Contents for HeartScreen112 Clinic

Page 1: ...ide built colour touch screen LCD display R 6730 EN02 E INNOMED HS112 C 1 HeartScreen112 Clinic channel ECG device with 112 mm wide built colour touch screen LCD display INNOMED MEDICAL HeartScreen112 Clinic channel ECG device with 112 mm wide built in printer ...

Page 2: ...HS112 C 1 User Manual 2 73 R 6730 EN02 E ...

Page 3: ...e for creating good quality ECG records 18 7 1 Requirements for good quality ECG record creation 18 7 1 1 Limb lead placement 18 7 1 2 Precordial lead placement 19 7 2 Defibrillation 19 7 3 Using a high frequency surgical knife 19 8 Monitoring mode 20 8 1 Using the touch screen 21 8 2 Heart rate warning 22 8 3 The QRS sound 22 8 4 Automatic shutdown 22 8 5 Selecting the number of displayed leads 2...

Page 4: ...ce menu system 40 10 1 Entering the menu system 40 10 2 Entering the sub menus 41 10 3 Parameter modification 41 10 4 Returning to monitoring mode 41 11 Managing stored records Catalogue 42 11 1 Displaying the catalogue 42 11 2 Deleting a record 43 11 3 Printing all record data 43 11 4 Managing record data 44 11 4 1 Managing the ECG record 44 11 4 2 Managing the rhythm record 45 11 4 3 Managing th...

Page 5: ...en 60 18 8 Pacemaker pulse detection 60 18 9 ECG amplifier 60 18 10 Digitalizing features 61 18 11 Printing features 61 18 12 Display 61 18 13 Communication parameters 62 18 14 Mechanical informative data 62 19 Guidelines and manufacturer s statement electromagnetic compatibility 63 20 Appendix I Decision categories 66 20 1 Rhythm analysis decision categories and rules 66 20 2 Depolarization analy...

Page 6: ...part requires written authorization from our company All brand names and logos are registered trademarks of their respective owners All rights reserved Please read the ECG s user manual and familiarize yourself with the control layout and the functionality of the control buttons Device manufactured and distributed by Innomed Medical Medical Development and Manufacturing Inc H 1146Budapest SzabóJóz...

Page 7: ...0601 compliant devices are connected and that the patient does not come into contact with any devices connected to the mains power supply If the device is used connected to a computer make sure that the patient is kept at an at least 1 5 m distance from the computer or that the computer is operated from an isolation transformer The defibrillator protection of the device is guaranteed only with one...

Page 8: ...ble to display the 12 channels online and store records on a big screen PC Record identification in the HS112 C 1 is done using not only a time and date stamp but also through the assignment of an automatically generated identification code or through a patient identification code and patient name entered by the user The archiving task is performed by a PC based cardiological database management s...

Page 9: ...rdiograph in an enclosed space with temperatures between 0 C and 45 C and a relative humidity below 95 at 25 C The air must not contain any corrosion causing pollution If the above conditions cannot be met the device must be stored in its original or comparable packaging Individual devices are shipped in a carrying case inside of a sealed protective cardboard box packaging If the electrocardiograp...

Page 10: ...e buttons cannot cause failure Interact with the screen only using your fingers Do not use any tools or instruments The expected lifetime of the device is 8 years The expected lifetime of the battery depends strongly on use but it averages at approximately 3 years In the service documentation the manufacturer provides the circuit diagram accessory list descriptions calibration instructions and oth...

Page 11: ...the battery is discharged Stored data will not be lost In case of a defective or insufficiently charged battery the device will shut down if there is an interruption of power supply When turning the device back on the screen will be black 3 4 Environmental protection Disposal of old electrical and electronic equipment applicable in the European Union and other European countries with separate coll...

Page 12: ...wer on off button Intended for indoor use Type CF defibrillator protected ECG mains noise filter ECG muscle noise filter ECG baseline filter Caution consult documents Product shall not be treated as household waste Keep dry Keep away from sunlight IP 20 Ingress Protection Marking Internally powered device S N Serial number Battery empty Functional earth Protective earth R 6730 EN02 E Caution consu...

Page 13: ...ymbol appears in the top right corner of the display under the HR symbols When the device operates on the mains power supply there is no battery indicator If the charge level of the battery is very low the indicator turns red and starts to blink in the rhythm of the QRS The colour of the battery indicator reflects the charge level however it does not directly correspond to the remaining operationa...

Page 14: ...ory reset In case of malfunction of the device you can reset the factory setting by switch on the device with more than 10sec pressing of the ON button Press it while you hear a sound If during pressing the GREEN LED become off release the button and immediately press it again for more than 10 sec until appearing the sound Caution The factory reset clear all memory all records and set the factory ...

Page 15: ...e recording paper The records printed on the paper supplied by Innomed Medical retain their legibility for 8 years provided that the storing conditions described in the instructions are met 5 2 1 General remarks about printing The device starts each printing session at the beginning of a page and rolls the paper out until a page boundary at the end of each session This makes tearing the paper off ...

Page 16: ...ds displayed on it Directly accessible buttons on the device are the following 1 Power on off button mechanical The dedicated buttons below are touch buttons 2 Menu and monitoring selection button 3 Channel number selection button in monitoring mode 4 Storage program selection button 5 Diagnosis program selection button 6 Manual printing start and stop button 7 Filter on off button 8 Curve speed s...

Page 17: ... connector The right side of the device with the connectors The back side of the device Hereinafter the controls and connectors will be referred to with their respective names as defined in this section Touch buttons will be referred to using their picture representation e g while touch screen controls will be referred to by specifying their name e g OK 16 17 15 12 13 14 ...

Page 18: ... 1 1 and 7 1 2 The patient s skin should be cleaned from body oil and moisturizers and shaved if necessary e g in case of a hairy chest Before each use the electrodes have to be cleaned It is extremely important that no dried gel remains on the electrodes The clamp and suction type electrodes should be applied with gel provided by Innomed Medical or other comparable quality gel recommended for ECG...

Page 19: ... so the N character is always coloured yellow If the ECG is noisy make sure that the ECG cable does not cross any mains cables If need be disconnect the mains power supply cable and operate the device on battery or turn the mains noise filter on 7 2 Defibrillation The device is defibrillator protected when using an approved ECG cable but it is recommended to remove the precordial electrodes before...

Page 20: ...ing will always start with the latest settings retained after shutdown with the exception of the baseline filter which is turned on for the printer and turned off for the display at each start up The following figure shows the information displayed during monitoring If a wireless connection is available an indicator icon appears on the right side of the display Wireless communication can be disabl...

Page 21: ...r interpretation is described in section 9 3 which deals with rhythm analysis At a 5mm sec sweep speed and a heart rate above 160BPM there are no markings Electrode attachment warning as described in section 7 1 2 8 1 Using the touch screen Handling the device s touch screen is similar to handling modern mobile phones The menu items can be selected and settings can be adjusted through touching or ...

Page 22: ...nd a periodic siren sound is emitted and the heart rate indicator turns red and starts blinking The sound can be muted by touching the screen however the red blinking of the indicator will continue After the event the sound is unmuted automatically and following warnings will be signaled by sound again Caution The warning triggered by this function serves for information purposes only It cannot be...

Page 23: ...es following the order 3 6 12 By button the number of channels changes cyclically following an ascending channel display is chosen a rhythm channel with a fixed 5 mm s speed appears on the bottom part of the screen The displayed rhythm lead can be changed by a horizontal swipe leftward or rightward on the rhythm curve with one finger Selecting the number of the displayed leads is not allowed durin...

Page 24: ...nd index finger placed one above the other Pull the fingers apart in a vertical direction starting from the middle of the screen to increase the sensitivity Place the two fing bottom edges of the screen and bring them closer together to decrease thesensitivity The set value is displayed in cm mV in the bottom right corner of the display and during printing in the header on the printout selection d...

Page 25: ...ns noise and muscle noise filters can be turned on or off by using the the touch screen touching the icons The status of the filters is indicated by the symbols located on the right side of the display line filter is designed to eliminate the vertical drift of the ECG signal There is one baseline filter for printing and storage and another one for the display The former is a higher quality FIR fil...

Page 26: ...user wishes to print a two page record the button can be pressed at any time while the second page is being printed The same system applies for any number of pages This method is useful for good paper utilization If the button is been pressed towards the end of the page the printing might continue until the end of the following page Therefore it is advised to stop the printing as soon as possible ...

Page 27: ...it will depend on the amplitude of each waveform If a large amount of overlap cannot be avoided the settings will be reset to equal positioning If any of the precordial electrodes are not connected their place will be left out and no line will be drawn for them In case a limb electrode is not connected the device will not print Actual printing speed With 50 mm s printing the actual speed of the pa...

Page 28: ...as the header printed during direct online printing The calibration signal is printed only before the first group Even though in these cases the leads are printed in groups of three or six all groups are recorded simultaneously If pre start Setup Printing Pre start is enabled 2 seconds of signal prior to pressing the button will also be printed This way it is possible to print out a signal which h...

Page 29: ...gree rotation 8 13 3 Stopping automatic printing Automatic printing can be stopped by pressing the or button or it will stop automatically after all leads have been printed In the case of a 3 channel setting with a 2 second length and in ECO mode the printout looks as follows ...

Page 30: ...will also perform a rhythm analysis provided at least 40 beats occur during the recording The printed form of the rhythm analysis can be seen in the respective subsection Storage parameters can be set under the Setup Store menu item If pre start Setup Printing Pre start is enabled 2 seconds of signal prior to pressing the program button will also be stored This way it is possible to store and prin...

Page 31: ... the results of the rhythm analysis in case of at least 1 minute of recording When the counter reaches 0 and data acquisition is complete the program processes the data After this a catalogue list will appear showing the new record The stored record and related data can then be viewed as described in section 11 Managing stored records or monitoring can be resumed 9 1 3 Automatic printing after run...

Page 32: ... the 45 175 BPM heart frequency range with all 10 electrodes in place If pre start Setup Printing Pre start is enabled 2 seconds of signal prior to pressing the button will also be analysed and stored This way it is possible to analyse a signal which has already been displayed Analysis data heart rate QRS length in ms P Q distance in ms Q T Q Tc distance in ms P wave angle in degrees QRS angle in ...

Page 33: ... acquisition of data required by the program With the start of the program the device disables the mains and muscle noise filters in case they were enabled The status of the baseline filter remains unchanged The filters are not turned back on automatically after the program has run If the device detects less than 6 beats during the 16 second data acquisition period it will display the following me...

Page 34: ...d axis position parameters will be printed on the bottom strip of the ECG printout This is a useful printing setting and a factory default setting Because of the parameter listings this is the preferred printing mode over automatic printing 9 2 4 Aborting the program The program can be aborted by pressing the button or by pressing the button one more time The program stops and monitoring mode is r...

Page 35: ...he end of the QRS on each of them and calculating the QRS width based on these measures Width based categories are Normal QRS_length 120 ms Wide 120 ms QRS_length 160 ms Extra wide 160 ms QRS_length In the case of a long beat the program does not differentiate between beats based on their width It will indicate that there has been a change at the stimulus source e g sinus arrhythmia or escape beat...

Page 36: ...itored lead Pressing the button during monitoring starts the STORE program during which an arrhythmia analysis is performed if the length of the rhythm record is at least 1 minute 9 3 2 Running the program When the program starts its name appears in the top left corner of the display along with a counter which indicates the remaining time for the acquisition of data required by the program The max...

Page 37: ...viation R R C V deviation average in Average pulse rate BPM Total number of beats Number of rhythmic narrow QRS beats Number of rhythmic wide QRS beats Number of rhythmic extra wide QRS beats Number of premature narrow QRS beats Number of premature wide QRS beats Number of premature extra wide QRS beats Number of long beats Bradycardia tachycardia or asystole during the measurement The printed tab...

Page 38: ...R R n R R n 1 function Represents the R R distance as a function of the preceding R R distance This shows the nature of the arrhythmia how consecutive R R distances vary Their representation on the printout 9 3 5 Automatic printing after running theprogram If the Prog Print option has been enabled for some record type in the printer settings after the program has run printing will start For exampl...

Page 39: ...bove occurs a 4 second long curve is printed with the event approximately at its centre After starting the program the length of the first event is approx 6 seconds during which the patient data is printed the same way as in the ECO printing mode The following printouts are 4 seconds long and indicate the time of printing below the curves Caution The results of the measurements are not stored exce...

Page 40: ...e monitoring screen The bottom row of the main menu contains the software version of the device It also is possible to access the three sub menus of the main menu directly from monitoring mode by using the touch screen Enter the Catalogue menu by touching the bottom right corner of the screen for 2 seconds Enter the Setup menu by touching the bottom left corner of the screen for 2 seconds Enter th...

Page 41: ... a parameter two kinds of operations may be performed If there is a choice between two values touching the menu item is used to switch between the values e g switch from an Off status to an On status In there is a choice of several values a selection list appears from which the choice can be made Pressing the Ok button confirms the choice 10 4 Returning to monitoring mode To return to monitoring m...

Page 42: ...rding Diag ECG Ritm type of records attached is there a diagnosis ECG and rhythm length in seconds The catalogue is displayed in the following format Record selection can be performed by touching the record number A red record number indicates the currently selected record At most 10 records can be displayed on the screen If there are more than 10 records swiping the screen upward or downward with...

Page 43: ...rinting all record data Pressing the button in the main menu of the catalogue when the list of records is displayed prints out all stored elements of the selected record indicated by the red record number The elements are printed in the following order if available Diagnosis program Header Stored ECG record of the 12 channels Rhythm curve with a 5 mm s sweep speed Average curves with a fixed 25 mm...

Page 44: ...t with gestures on the monitoring Activating and deactivating filters by pressing the button Changing leads by pressing the button this cannot be manipulated by swiping the Since the length of the record may exceed the width of the display the record can be scrolled by swiping leftward or rightward on the screen The beginning and end time of the current section is shown at the bottom of the screen...

Page 45: ... of the rhythm record corresponds to the settings under Setup Store if the record was stored with the storage STORE program is set to 16 second if the record was created with the analysis diagnosis DIAG program Since the length of the record may exceed the width of the display the record can be scrolled by swiping the screen horizontally The beginning and end time of the current section is shown a...

Page 46: ...112 C 1 User Manual 46 73 R 6730 EN02 E The following data are displayed Arrhythmia parameters R R distance distribution Extra beat distribution R R distance trends Variation of consecutive R R distances ...

Page 47: ... printout corresponds to the sensitivity of the displayed rhythm If a rhythm analysis has been created the device will also print out the table and distributions button returns to the previous menu Managing the analysis diagnosis results results of the analysis diagnosis can be viewed button The averaged QRSs parameter tables and diagnosis text can be The diagnosis screens can be browsed by swipin...

Page 48: ... QRS curve of the 12 channels time and axis information of the QRS waves curve amplitude and time data of the 12 channels the suggested diagnosis Pressing the or OK button returns to the previous menu Caution In case a pacemaker signal is present the device will only perform an analysis No diagnosis will be obtained The presence of a pacemaker impulse causes morphological differences which may lea...

Page 49: ...HS112 C 1 User Manual R 6730 EN02 E 49 73 The amplitude and time parameters on the printout ...

Page 50: ...od pressure Systole Diastole HR limits min max Date and time can also be set in this menu 12 1 Patient data of the last 20 patients The device stores the patient data of the last 20 patients These can be listed by pressing the button after which a specific patient can be selected This function is useful when performing daily recordings of the same patients in a clinic Storage is activated on patie...

Page 51: ...board enter the name using alphanumerical characters Capital letters are automatically set by the device i e the first letter after a space character will be capitalized The Back button can be used to delete the last character entered The name can be stored by pressing the Ok button which brings up the patient data settings where the newly entered name will be visible Caution If the first button p...

Page 52: ...value of the date of birth field displays the value in inverse colour and a numpad is shown on the display A value can be entered by pressing the numbers on the numpad If the value is higher than allowed the device will not accept the entry and it can be deleted using the Back button and the appropriate number s can be entered Pressing the Ok button will store the date of birth and the next field ...

Page 53: ...mits min max the HR warning has to be enabled under Settings Others in order for the device to signal when the set limits are exceeded 12 8 Exiting the patient menu Returning to monitoring from the Patient ID menu is possible by pressing the Ok button when no field is selected ...

Page 54: ... Setup menu item A simpler way to enter device setup is to touch the bottom left corner of the monitoring screen A typical sub menu language settings is shown in the figure below The specific elements of the setup menus are described below Factory defaults are shown in brackets After a complete memory reset Setup Others Memory clear these states will be set ...

Page 55: ...13 2 Diagnosis Setting the parameters of the diagnosis DIAG program 1 12 lead ECG The length of the ECG record stored with the diagnosis 0 4 6 or 8 seconds 4s 2 Rhythm lead Selecting the lead of which a rhythm record is to be made during diagnosis II 3 Marker During diagnosis the device derives average curves for reach channel and determines typical points on them If the marker setting is enabled ...

Page 56: ...urned on This setting does not correspond to that of the display baseline filter 13 6 Others 1 QRS volume 0 1 2 3 0 0 is mute 2 Key sound 0 1 2 3 1 0 is mute 3 Backlight 0 1 2 3 2 The backlight of the display Set to 2 every time the device is turned on In battery mode the battery lasts longer if this value is lower 4 Colors 0 1 2 3 0 The colour of the display When turning the device on the last se...

Page 57: ...n electrode attachment error while printing or starting a program Check the leads in the 12 channel mode The ECG is too noisy Check the electrodes turn the filters on There are few recognizable beats Appearing during diagnosis creation if the number of beats is too low 15 Computer connection The Innobase for Windows cardiological database management program can be purchased for the HS112 C 1 devic...

Page 58: ...ser manual 1 pc Innobase for Windows cardiological database management system installation CD optional 1 pc Innobase for Windows user manual optional 1 pc Carrying case optional 1 pc Defibrillator protected patient cable KPACDR or KPACDL 4 pcs Limb electrodes clamp 6 pcs Precordial suction electrodes 1 pc Electrode gel 260g 1 pc USB A B cable optional 1 pc 112 mm fold printer paper with a raster g...

Page 59: ...5 C Operating environment dry closed space Operating and storage pressure 550 1060 hPa Environmental protection IP20 the device protected from middle sized solid objects 12mm but it is not protected from water intrusion 18 3 Mains and power supply Mains voltage 110 230VAC Mains frequency 50 60 Hz Mains power consumption 2A 110VAC 1 A 230VAC Battery type 2600 mAh only Innomed produced battery is us...

Page 60: ...brera 3 channels aVL I aVR II aVF III V1 V3 V4 V6 6 channels aVL I aVR II aVF III V1 V2 V3 V4 V5 V6 12 channels aV V6 18 7 Heart frequency measurement Measurement range 30 300 BPM Accuracy 1 BPM or 2 18 8 Pacemaker pulse detection When the device examines a patient with a pacemaker recognizes the pacemaker signal within certain ranges according to the technical parameters and graphically displays ...

Page 61: ...l range 700 mV Stored signal resolution 500 Hz 10 uV bit Resolution in case of PC connection during online ECG transfer 500 Hz 5 V bit Recording Format PDF 18 11 Printing features Effective recording width per channel 40 mm overlap allowed Printer head resolution In amplitude direction 8 points mm On the time axis 8 or 16 points mm Printing speed 5 25 50 mm s Paper width 112 mm 0 1 mm Paper block ...

Page 62: ...ication parameters Communication USB Communication services optional online monitoring of 12 leads ECG device control from PC record creation and storage directly on the PC 18 14 Mechanical informative data Size 295 x 225 x 80 mm Weight informative 1 9 kg ...

Page 63: ...f wood concrete or tile If the floor covering is made of plastic relative humidity must be minimum 30 Burst 2 kV on mains cable 2 kV on mains cable Quality of mains energy must IEC 61000 4 4 1 kV on input 1 kV on input output comply with the average of output cable cable commercial or hospital environment Surge 1 kV differential 1 kV differential mode Quality of mains energy must IEC 61000 4 5 mod...

Page 64: ...se of 80 MHz and 800 MHz the higher frequency range must be applied guideline must not be used for each case Electromagnetic transmission is influenced by absorption and reflection caused by buildings objects and people It is not possible to define accurately the field intensity of stable transmitters for example t cellular phones mobile radios amateur radios AM FM radios and television broadcasti...

Page 65: ...output of the transmitter W Defence distance depending on the frequency of the transmitter m 150 kHz 80 MHz d 3 5 V1 P 80 MHz 800 MHz d 3 5 E1 P 800 MHz 2 5 GHz d 7 E1 P 0 01 0 1166 0 1166 0 232 0 1 0 37 0 37 0 74 1 1 16 1 16 2 32 10 3 7 3 7 7 4 100 11 6 11 6 23 2 In case of transmitters with the highest output in the above table d defence distance in meters can be defined with the equation depend...

Page 66: ...s SINUS RHYTHM WITH EXTRASYSTOLE OR ARTEFACT The R R distances are regular the QRS complexes however show deviation to each other which could be the result of noise SINUS BRADYCARDIA The sinus rhythm conditions are met but the heart rate is less than 60 min SUPRAVENTRICULAR TACHYCARDIA OR FLUTTER The sinus rhythm conditions are met but the heart rate is over 120 min SINUS TACHYCARDIA The sinus rhy...

Page 67: ...Variable R R distances identical QRS complexes P wave cannot be detected REGULAR R R DISTANCES NO P WAVE ACCELERATED AV JUNCTIONAL RHYTHM Regular R R P cannot be detected heart rate 60 100 min Possible accelerated junctional rhythm SUPRAVENTRICULAR TACHYCARDIA Atrium originating rapid heart rate with regular R R distances VENTRICULAR TACHYCARDIA Ventricle originating rapid heart rate with wide QRS...

Page 68: ...I must reach 25ms 30ms on leads III and aVF PATHOLOGICAL R ON V1 V2 POSTEROBASALIS MYOCARDIALIS INFARCTUS QRS width must be under 110ms The R wave measured on V1 must exceed 4mm and at the same time be greater than the S wave measured on V1 On lead V2 the R wave must be 100 greater double than the S wave PATHOLOGICAL Q ON II III aVF AND PATHOLOGICAL R ON V1 V2 INFERIOR PBMI In this class the condi...

Page 69: ...HYA The QRS width must be under 120ms R onV2 must exceed 6mm 10mm on V1and these values must be greater than the S waves S R ratio mut be greater than 1 on limb lead I as well FIRST LEFT VENTRICULAR HYPERTROPHYA Conditions QRS must be under 120ms no significant S deviation on V5 and T on V5 must be greater than 5mm SECOND LEFT VENTRICULAR HYPERTROPHYA QRS requirement under 120ms ST depression on V...

Page 70: ...eeding 1mm on leads V2 V3 NEGATIVEV T WAVE ON LEADS V2 V3 Its condition is that T wave negativity exceeds 1mm on V2 V3 ANTERO SEPTALIS ISCHAEMIA Conditions are met if ST deviation or negative T is detected on V2 V3 ST ELEVATION ON LEADS I aVL V5 V6 For conditions to be met elevation exceeding 1mm is required on leads I and aVI ST DEPRESSION ON LEADS V5 V6 Its condition is ST value exceeding 1mm NE...

Page 71: ...terized the image that is there must not be sharp ST depression on the leads Other conditions are identical to the previous item SIGNIFICANT ST DEPRESSION ON SOME LEADS ISCH HEART DISORDER OR D INTOX Its condition is ST depression on at least four leads their values less than 2mm in each case that is rather 1mm ST DEVIATION ON ONE LEAD CHECK THE ELECTRODES Its condition is ST deviation on only one...

Page 72: ...y gel on them Check electrode positions and try to adjust precordial electrode placement HR is not measured Electrode attachment is not registered Check the attachment of the electrodes See the previous point HR error The device does not find any QRSs Check the ECG as described in the previous two points HR measurements are incorrect The device locates the QRSs incorrectly Check the quality of ECG...

Page 73: ...acturer After some time a few years the printout fades Paper related issue Use the paper recommended by the manufacturer With proper storage the content is preserved for up to 8 years Make a photocopy or scan of the printout The operation time of the device running on battery is limited The battery is too old Replace the battery The device is connected to the mains power supply but the charge indi...

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