Edan Instruments, Inc. VE-300 User Manual Download

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EDAN INSTRUMENTS, INC

Manual Ver: V1.2
Release Date: March 2009
Part Number: MS1R-107182-V1.2

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Summary of Contents for VE-300

Page 1: ...EDAN INSTRUMENTS INC Manual Ver V1 2 Release Date March 2009 Part Number MS1R 107182 V1 2 VE 300 Veterinary Electrocardiograph ...

Page 2: ...ned in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsibl...

Page 3: ...y or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure Revision History Date ECO Version Description 2008 01 V1 0 1st edition 2008 08 ECO QR 8029 V1 1 2nd edition 2009 03 ECO SE 9005 V1 1 Added some information according to FDA ...

Page 4: ... and Switch 17 3 4 Rear Panel 17 3 5 Bottom Panel 18 4 Operation Preparations 21 4 1 Power and Earthing 21 4 2 Loading Replacing Record Paper 22 4 3 Patient Cable Connection 23 4 4 Electrode Connection 24 4 5 Inspection before Power On 25 5 Operation Instructions 27 5 1 Switching On 27 5 2 AUTO Mode 27 5 3 MANUAL Mode 28 5 4 RHYTHM mode 28 5 5 USBPRT mode 29 5 6 ECG Recall Operation 29 5 6 1 ECG R...

Page 5: ...able 52 8 1 2 Cleaning the Electrodes 52 8 1 3 Cleaning the Print Head 52 8 2 Disinfection 53 8 3 Care and Maintenance 53 8 3 1 Recharge and Replacement of Battery 53 8 3 2 Record Paper 54 8 3 3 Maintenance of Main Unit Patient Cable Electrodes 54 9 Warranty and Service Policy 57 9 1 Warranty 57 9 2 Service Policy 57 10 Accessories 59 11 EMC Information Guidance and Manufacture s Declaration 60 11...

Page 6: ... and diagnose heart disease 1 2 Safety Warnings WARNING 1 The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained They should be familiar with the contents of this user manual before operation 2 Only qualified service engineers can install this equipment and only service engineers authorized by EDAN can open the shell 3 Only qualified installation...

Page 7: ...uld be used while defibrillating 14 There is no danger for animals with pacemaker However if a pacemaker is used the results given by the equipment may be invalid or lose the clinical significance 15 Do not touch the animal bed table and the equipment while using defibrillator or pacemaker simultaneously 16 In order to avoid burning please keep the electrode far away from the radio knife while usi...

Page 8: ...lly and pay more attention to warning messages 22 Only qualified service engineer authorized by EDAN can open the battery compartment and replace the battery and the battery of same model and specification provided by manufacturer should be used 23 Danger of explosion Do not reverse the anode and cathode when connecting the battery 24 Do not heat or splash the battery or throw it into fire or wate...

Page 9: ...the equipment patient cable and electrodes etc should be checked Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or performance 5 The following safety checks should be performed at least every 24 months by a qualified person who has adequate training knowledge and practical experience to perform these tests a Inspect the equipment and ...

Page 10: ...vely they can be returned to the dealer or the manufacturer for recycling or proper disposal 8 Federal US law restricts this device to sale by or on the order of a veterinarian 1 5 Cleaning Disinfection Cautions CAUTION 9 Turn off the power before cleaning and disinfection If mains supply used the power cord should be drugged out of the outlet also Prevent the detergent from seeping into the equip...

Page 11: ...ance and high reliability and the compact size makes it suitable for clinic and hospital use Configuration Main unit and accessories power cord earth wire patient cable electrodes and thermal record paper WARNING This equipment is not designed for direct cardiac application WARNING The results given by the equipment should be examined with respect to the overall clinical condition of the animal An...

Page 12: ... and net port for linking to special network and setting up ECG database 2 2 List of Symbols External output External input Equipment or part of CF type with defibrillator proof Attention general warning see accompanying document Potential equalization Mains supply On mains supply Off mains supply Battery indicator Battery recharging indicator Sensitivity switch key ...

Page 13: ...trocardiograph User Manual 8 Recall key 1mV calibration key Copy key Mode RST switch key Lead switch key Print Stop key ON OFF key Menu key Up Arrow Down Arrow key Left Arrow Right Arrow key Recycle Part Number Serial Number ...

Page 14: ...Community CE Mark The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life and that this unit was put on the market after 13 August 2005 Rx only U S Federal U S Law restricts this device to sale by or on the order of a veterinarian ...

Page 15: ... mark VET ECG Trade name Classification Symbol equipment of CF type with defibrillator proof 3 1 1 LCD Screen The LCD Screen specification 192 64 dot single color LCD Screen Normally the contents displayed on the LCD screen include descript from left to right AUTO Paper M 02Y I II III 10mm mV 60 LCD Screen Label Recorder Control Panel ...

Page 16: ... lead І П Ш aVR aVL aVF V Sensitivity 2 5mm mV 5mm mV 10mm mV 20mm mV AGC Heart rate Actual heart rate Battery capacity Only when the built in battery is used Third Row ECG wave 3 1 2 Control Panel and Keys 1 Indicator Lamp Mains supply indicator lamp when mains supply is used the lamp will be lit Battery indicator lamp when the built in rechargeable Lithium battery is used the lamp will be lit ...

Page 17: ...e pressed to record a 1mV calibration pulse at any time while recording In the AUTO mode once a complete ECG was recorded this key can be pressed to recall the electrocardiogram that recorded last time 5 MODE RST Mode Switch Key This key can be pressed to select record mode between AUTO MANUAL RHYTHM USBPRT and OFF The switching order of lead groups is listed in Table 3 1 Recording in the Manual m...

Page 18: ...ch is determined by settings of lead sequence and record format in the MENU 6 LEAD Lead Switch Key In the MANUAL mode press the key to switch the lead group In Recall window or Menu interface this key can be pressed to turn the pages 7 PRINT STOP Key Used to begin recording and stop recording 8 ON OFF Key When the unit has been powered on press this key to turn on it Press again to turn off it 9 M...

Page 19: ...keys can also be pressed to change the content of the selected item hereinafter called Left Right 3 2 Patient Cable Socket and Signal Interface There are sockets including the patient cable socket RS232 socket external input output socket and USB interface at the right side of the main unit as following Figure shows 1 Patient Cable Socket Applied part of type CF with defibrillator proof Attention ...

Page 20: ...NC 10 L LA input 15 N or RF RL input Note The left side of is European standard and the right side is American standard 2 RS232 Socket WARNING RS232 interface is 1500V AC isolated intensity and the maximum voltage applied should not exceed 15V DC Definition of corresponding pins Pin Signal Pin Signal Pin Signal 1 NC 4 NC 7 NC 2 RxD input 5 GND 8 NC 3 TxD output 6 NC 9 NC 3 External Input Output So...

Page 21: ...he respective IEC EN standards e g IEC EN60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the standard IEC EN 60601 1 1 Therefore anybody who connects additional equipment to the signal input or output connector to configure a medical system must make sure that it complies with the requirements of the...

Page 22: ... equalization conductor provides a connection between the unit and the potential equalization bus bar of the electrical installation 2 Mains Supply Socket AC SOURCE alternating current supply socket 3 Power Switch Switch on Switch off 3 4 Rear Panel Mains Power Switch Potential equalization terminal Mains Supply Socket Net Port ...

Page 23: ...VE 300 Veterinary Electrocardiograph User Manual 18 3 5 Bottom Panel Fuse Mains Supply Shift Switch Fuse Label Battery Compartment Label ...

Page 24: ...or cloth cleanse it with clean water at once If the leakage liquid gets into your eyes do not wipe them Irrigate them with clean water first and go to see a doctor immediately WARNING Only qualified service engineer authorized by EDAN can open the battery compartment and replace the battery and the battery of same model and specification provided by manufacturer must be used 2 Mains Supply Shift S...

Page 25: ...VE 300 Veterinary Electrocardiograph User Manual 20 WARNING Ruptured fuse must only be replaced with that of the same type and rating as the original ...

Page 26: ...f the unit If mains supply is used connect the power cord to the socket first and then connect the plug of the cord to the hospital grade outlet Rated input voltage 100V 115V or 220V 240V Rated frequency 50Hz 60Hz Rated input power 35VA Make sure the mains supply meets the above requirements before power on and then press the mains power switch to power on the unit Then the mains supply indicator ...

Page 27: ... Replacing Record Paper Two kinds of paper can be used as ECG record paper One is Rolled thermal paper with 80mm width and the other is folded thermal paper with 80mm width Note When using folded thermal paper the Paper Roller is unnecessary and it can be taken out When there is no record paper loaded or it reaches the end of record paper warning message Paper will be given on the screen Under thi...

Page 28: ...ake off the wrapper of folded thermal paper and then put it in the Paper Tray with the paper s grid side facing the thermal print head while put the free end of paper upright 4 Pull about 2cm of paper out and put down the recorder casing 5 Secure the casing by pressing it firmly 4 3 Patient Cable Connection WARNING The performance and electric shock protection can be guaranteed only if original ED...

Page 29: ...s and Color Codes European American Electrodes Identifier Color code Identifier Color code Right fore limb R Red RA White Left fore limb L Yellow LA Black Right rear limb N or RF Black RL Green Left rear limb F Green LL Red Chest C White V Brown As the following figure shows the electrodes positions on body surface are European Standard American Standard Dog Cat Dog Cat The contacting resistance b...

Page 30: ...efore Power On In order to avoid safety hazards and get good ECG records the following inspection procedure is recommended before power on and operation 1 Environment Check and make sure that there is no electromagnetic interference source around the equipment especially large medical electrical equipment such as electrosurgical equipment radiological equipment and magnetic resonance imaging equip...

Page 31: ...r Ensure that there is enough recorder paper loaded correctly 6 Animal The animal should not contact conducting objects such as earth and metal part of bed etc Ensure the animal is warm and relaxed and breathe calmly WARNING The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained and they should be familiar with the contents of this user manual be...

Page 32: ...ically and begin recording the ECG signal of that lead group And there is a blank on the recording paper before recording the next ECG signal Moreover a 1mV calibration mark will be recorded at the beginning of recording The lead group switching orders are listed in Table 3 1 Operation Method 1 Press MODE RST key to choose AUTO mode which will be displayed in the top left corner on LCD screen 2 Pr...

Page 33: ...sed to print out 1mV mark while ECG recording 6 Press PRINT STOP key to stop recording after finishing ECG record LEAD left and right arrow key can be pressed to switch the lead group during the course of recording Pressing PRINT STOP again during the course of recording can stop recording However when begin to record later ID number will change automatically according to the current time If the I...

Page 34: ...l stop automatically after recording a full ECG report 5 6 ECG Recall Operation 5 6 1 ECG Recall Press RECALL key to enter the recall window where patient files are saved The recall window allows files to be stored deleted printed and transmitted When there is no space for more files to be stored in the recall window the message Mem Full is displayed on the main interface Recall Window a Recall Wi...

Page 35: ...sk to the electrocardiograph press Left or Right to choose USB to ECG and then press PRINT STOP or MENU key to begin to import Note To import files in U disk to electrocardiograph there should be some files in the folder named ECGDATA in the U disk The folder name ECGDATA must be capital letters And the user should not change the name of files in the ECGDATA folder During the course of USB to ECG ...

Page 36: ...the user wants to copy all the files from the electrocardiograph to the U disk press Left or Right to choose ALL to USB and then press PRINT STOP or MENU key to begin to copy after a while all the files will be copied into the ECGDATA folder of the U disk automatically During the course of ALL to USB if something wrong happens the electrocardiograph will give the error information And then the use...

Page 37: ...to copy this file to the U disk press Left or Right to choose To USB and then press PRINT STOP or MENU key to begin to copy 6 Press RECALL key to return to the main interface Note To save the ECG data to the recall window as patient files please refer to 5 8 5 Save Option Settings 5 6 2 ECG Copy In the auto mode once a complete ECG was recorded pressing 1mV Copy key can recall the electrocardiogra...

Page 38: ...ity on the main interface to save the modifications the user should enter the menu interface and exit After that the user will see the modifications on the main interface when he turns on the electrocardiograph again 5 8 Settings 5 8 1 Filter Settings Four filters can be set in the MENU window They are AC FILTER EMG FILTER DFT FILTER and LOWPASS FILTER AC FILTER AC FILTER suppresses AC interferenc...

Page 39: ...e cutoff frequency is user defined at 150Hz 100Hz or 75Hz All the input signals whose frequency is higher than the setting cutoff frequency will be attenuated 5 8 2 Record Settings RECORD FORMAT When RECORD FORMAT is 3Ch limb leads will be recorded in 2 groups of 3 When RECORD FORMAT is 3Ch 1R limb leads will be recorded in 2 groups of 3 with one rhythm lead at the bottom of recording paper When R...

Page 40: ...h only Short form is supported in RECORD LENGTH 5 8 3 Record Output Settings AVERAGE TEMPLT When AVERAGE TEMPLT is 2Ch 1R limb leads will be recorded in 3 groups of 2 with one rhythm lead at the bottom of recoding paper When AVERAGE TEMPLT is 3Ch limb leads will be recorded in 2 groups of 3 When AVERAGE TEMPLT is Off there will be no average template when recording RR ANALYSIS When RR ANALYSIS is ...

Page 41: ...ot supported in this version 5 8 4 Other Record Settings LEAD SEQUENCE Standard Cabrera Lead Sequence Lead group 1 Lead group 2 Lead group 3 Standard І II Ш aVR aVL aVF V Cabrera aVL І aVR II aVF Ш V SAMPLE MODE 1CH Sequent Lead is sampled one by one in a certain sequence 3CH Sequent Lead group is sampled one by one in a certain sequence All CH Simu All leads are sampled simultaneously RHYTHM LEAD...

Page 42: ...fer ECG data to PC Smart ECG Viewer software of EDAN must be installed in PC Receive ECG Data window in the software should be opened up transfer type should be selected and other settings should be finished When AUTO TRANSFER is OFF the patient files can not be transferred When AUTO TRANSFER is UART AUTO firstly connect the serial port of PC and the RS232 socket of veterinary electrocardiograph w...

Page 43: ...G data from electrocardiograph through net LOCAL IP IP address of electrocardiograph 5 8 6 General Settings KEY BEEP When KEY BEEP is On a short beep sound will be made when press the control key When KEY BEEP is Off there is no sound while pressing the key QRS BEEP During the course of ECG recording if QRS BEEP is On the unit will make a short beep sound when an R wave has been detected So in nor...

Page 44: ... DEFAULT SETTING Select Restore to resume default setting value Note In the Parameter Options Column some parameters options have no underline which means these parameters have no default settings And when the user restores default settings these parameters will not change DATE MODE Date mode can be set as dd mm yyyy mm dd yyyy or yyyy mm dd After set the current date format will change according ...

Page 45: ...ff On 7 Record Speed 5mm s 6 25mm s 10mm s 12 5mm s 25mm s 50mm s 8 Record Length Short Medium Long Longest 9 Average Template 2Ch 1R Off 3Ch 10 Measurement Off On 11 Interpretation Off 12 RR Analysis On Off 13 Lead Sequence Standard Cabrera 14 Sample Mode All CH Simu 3CH Sequent 1CH Sequent 15 Rhythm Lead I II III aVR aVL aVF V 16 Paper Style Rolled Folded 17 Save Option Off On 18 Auto Transfer O...

Page 46: ... Setting Off On 26 Language Setting Chinese English 27 Lead Setting 7 leads 6 leads 28 Default Setting Restore 29 Data Mode dd mm yyyy mm dd yyyy yyyy mm dd 30 Date Setting 24 12 2007 31 Time Setting 08 23 32 ID 071224 0823 33 Password Password for entering the advanced control interface ...

Page 47: ... record a b Figure a shows the following content 10mm mV Sensitivity 0 15 100Hz Filter information AC50 50Hz AC Filter 08 01 2008 09 49 15 Date and time 1mV calibration mark I II III aVR aVL aVF V Lead name ECG wave of 7 leads in the format of 3Ch 25mm s Paper speed ...

Page 48: ...elected dominant beats PR int P R interval mean of P R interval from several of 12 selected dominant beats QRS Dur QRS complex duration mean of duration of QRS complexes from several of 12 selected dominant beats QT QTC int Q T interval mean of Q T interval from several of 12 selected dominant beats Normalized QT interval P QRS T axis dominant direction of the average integrated ECG vectors Note R...

Page 49: ...ectrocardiograph User Manual 44 5 10 RHYTHM mode record a b Figure a shows the following content 10mm mV Sensitivity 0 15 100Hz Filter information AC50 50Hz AC Filter 08 01 2008 09 51 19 Date and time 1mV calibration mark ...

Page 50: ...stogram and RR Trend Chart RR Interval measurement information includes the following content Current Date Current Time Animal Information ID Owner Name Type Age Sex BP Weight Measure Time Total R Num Total R wave number HR Heart Rate RR Avg Interval Average RR interval RR Max Interval Maximum RR interval RR Min Interval Minimum RR interval SDNN Standard Deviation of Normal to Normal Intervals RMS...

Page 51: ...VE 300 Veterinary Electrocardiograph User Manual 46 5 11 USBPRT mode record ...

Page 52: ...by doctor Report confirmed by Written by doctor ECG waveform of 7 leads 5 12 Switch Off When built in battery pack used press ON OFF key directly to turn off the unit after finishing ECG record When mains supply used press ON OFF key first after finishing ECG record and then switch off the mains supply by pressing the switch on the left side of the unit Pull off the plug from the outlet last Note ...

Page 53: ... is weak Paper Record paper has not been loaded or it has been run out PaperErr Feed paper error Sampling Printing ECG signal is being sampled Printed Modu Err There is something wrong with the signal sample module Demo The system is in demonstration mode Process The ECG data is being processed Transfer The patient file is being transferred through UART port or Ethernet Mem Full There is no space ...

Page 54: ...ion in the presence of flammable gas Equipment not suitable for use in the presence of flammable gas Working mode Continuous operation Classification EMC Group І type A Dimensions 288mm 210mm 70mm Weight About 2 5kg Display 192 64 dot single color LCD Screen Transport Storage Working Temperature 20 55 5 40 Relative Humidity 25 93 non condensing 25 80 non condensing Environment Atmospheric Pressure...

Page 55: ...m s 12 5mm s 25mm s 50mm s 3 Recording Accuracy of data 5 x axis 5 y axis Technique Peak peak detection HR Range 30 BPM 300 BPM HR Recognition Accuracy 1BPM Leads 7 standard leads Acquisition Mode simultaneously 7 leads A D Resolution 12 bits Time Constant 3 2s Frequency Response 0 05Hz 150Hz 3dB Sensitivity 2 5 5 10 20 mm mV Input Impedance 50MΩ 10Hz Input Circuit Current 50nA Input Voltage Range...

Page 56: ...5Hz OFF LOWPASS Filter 150Hz 100Hz 75Hz CMRR 110dB Sampling Frequency 1000Hz Patient Leakage Current 10 µ A 220V 240V Patient Auxiliary Current 0 1 µ A DC Dielectric Strength 4000V rms Input 100kΩ Sensitivity 10mm V 5 Single ended External Input Output Optional Output 100Ω Sensitivity 1V mV 5 Single ended ...

Page 57: ...sure there is no remainder gel Dry the electrodes with a clean dry cloth or air dry naturally 8 1 3 Cleaning the Print Head Dirty and soiled thermal print head will deteriorate the record definition So it should be cleaned at least once a month regularly Open the recorder casing and remove the paper Wipe the print head gently with a clean soft cloth damped in 75 alcohol For stubborn stain soak it ...

Page 58: ...arning message BAT WEAK will be displayed on LCD screen The battery should be recharged immediately 2 Recharge VE 300 is equipped with recharge control circuit together with built in rechargeable lithium battery When connect with the mains supply the battery will be recharged automatically And then the battery recharge indicator lamp and the mains supply indicator lamp will be lit at the same time...

Page 59: ...disposal or dispose the battery according to local regulations 8 3 2 Record Paper Note Record paper provided by manufacturer should be used Other paper may shorten thermal print head s life And the deteriorated print head may lead to illegible ECG record and block the advance of paper etc Storage requirements Record paper should be stored in dry dark and cool area avoiding excessive temperature hu...

Page 60: ... the device has to be repaired WARNING Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards 1 Main Unit Avoid excessive temperature sunshine humidity and dirt Put on the dustproof coat after use and prevent from shaking violently wh...

Page 61: ...term use the surface of electrodes will be oxidized because of erosion and other causes By this time electrodes should be replaced to achieve high quality ECG CAUTION The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal ...

Page 62: ...warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product is being repaired 9 2 Service Policy All repairs on products must be performed or approved by EDAN Unauthorized repairs will void the warranty In addition whether covered under warranty or not any product repair shall be exc...

Page 63: ... responsible for freight insurance custom charges from EDAN to service claimer Out of warranty the service claimer is responsible for any freight insurance custom charges for product Contact information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send email to EDAN service department at support ...

Page 64: ...ectrode LAUNCH M15R 040144 4 Paper roller EDAN MS1 19993 5 Thermal paper EDAN M50R 78076 The following accessories can also be ordered according to some special usage No Accessory Manufacturer Part No 1 Earth wire EDAN MS1 20016 2 Input output signal cable EDAN MS1 19907 3 Flat clip electrode LAUNCH M15R 040145 4 Carrying Bag EDAN MS1 107119 A0 VE 300 and accessories are available by contacting th...

Page 65: ...on CISPR 11 Class A Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies The VE 300 Veterinary Electrocardiograph is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies building used for domestic purposes 11 2 Electromagnetic Immunity for all EQUIPMENT ...

Page 66: ...les 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment Power frequency 50Hz magnetic field IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application o...

Page 67: ...with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM ...

Page 68: ...f the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz P V d 1 5 3 80 MHz to 800 MHz P E d 1 5 3 800 MHz to 2 5 GHz P E d 1 7 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation di...

Page 69: ...nhai Rd 1019 shekou Nanshan Shenzhen 518067 P R China TEL 86 755 26882220 FAX 86 755 26882223 EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn ...

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