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Safety Testing 

 

771402-2 dopplex ABIlity Service Manual                                    

52 

10.3  Electrical Safety Test:   USB (Enclosure Leakage) Test   

10.3.1 

Connect the unit under test as illustrated below to a suitable electrical safety analyser. 

 

 

 

 

 

 

 

 

 

 

10.3.2 

Switch on the unit. 

10.3.3 

Allow the unit to fully initialise before applying the tests in the table below.  

 

Test 

Test Limit 

Normal Polarity 

100

μA 

No L2 

500

μA 

Reversed Polarity 

100

μA 

No L2 

500

μA 

 

 

 

 

 

 

Live 

Earth 

Neutral 

Neutral from Analyser 

Earth from Analyser 

Live from Analyser 

Enclosure Socket of Analyser 

USB Socket 

Summary of Contents for DA100PB

Page 1: ...771402 2 dopplex ABIlity Service Manual 1 SERVICE MANUAL ...

Page 2: ... 2 Rear Panel 13 5 3 Base 14 5 4 Product Labelling 14 5 5 User Interface 16 5 6 System Connection 18 6 System Block Diagram 19 6 1 Base PCB assembly 20 6 2 Daughter PCB assembly 21 6 3 Regulator PCB assembly 21 6 4 Front panel PCB assembly 21 6 5 Printer Interface PCB 21 6 6 Manifold assembly 21 6 7 Pneumatic Circuit Diagram 22 7 Operating Principles 25 7 1 Cuff Inflation Deflation Control 26 7 2 ...

Page 3: ...cal Safety Test Mains Inlet to Enclosure Leakage Current 51 10 3 Electrical Safety Test USB Enclosure Leakage Test 52 10 4 Electrical Safety Test Printer Enclosure Leakage Test 53 11 Maintenance 54 11 1 Automatic Service Prompt Service Report 54 11 2 Air Filter Replacement 54 11 3 Rechargeable Battery Conditioning or Replacement 54 11 4 Cuffs 55 11 5 General Inspection 56 11 6 Real Time Clock Batt...

Page 4: ...pproved agents or distributors for further information on service contracts Manufactured in the UK by Huntleigh Healthcare Ltd As part of the ongoing development programme the company reserves the right to modify specifications and materials without notice Dopplex Ability and Huntleigh are registered trademarks of Huntleigh Technology Ltd 2011 Huntleigh Healthcare Ltd 2011 ...

Page 5: ...e cycle processes BS EN 980 2008 Symbols for use in the labelling of medical devices 2 2 CE Mark The dopplex Ability is in conformity with the Medical Devices Directive 93 42 EEC as amended by 2007 47 EC and has been subject to the conformity assurance procedures laid down by the Council 2 3 Classification Type of protection against electric shock Class II and Internally powered equipment with a f...

Page 6: ...tion WARNING These requirements must be met when a dopplex Ability is connected to any other electrical equipment such as a PC Non medical equipment must comply with the relevant IEC or ISO safety standard For Information Technology equipment this standard is IEC950 EN60950 Medical equipment must comply with IEC601 1 EN60601 1 or equivalent The configured system must comply with the requirements o...

Page 7: ... the exception of transducers and cables sold by the manufacturer of the dopplex Ability as replacement parts for internal components may result in increased emissions or decreased immunity of the dopplex Ability WARNING The dopplex Ability should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the dopplex Ability should be observed to verif...

Page 8: ... transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of the equipment marked with the following symbol NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reje...

Page 9: ...TE 1 At 80MHz and 800MHz the separation distance for 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 2 9 Electrostatic Discharge Electrostatic discharge ESD is a known problem that can affect electrical equipment If the dopplex Ability is subjected to E...

Page 10: ... UK Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Road Cardiff CF24 5HN United Kingdom T 44 0 29 20485885 F 44 0 29 20492520 E sales huntleigh diagnostics co uk W www huntleigh diagnostics com E mail cardiff service huntleigh diagnostics co uk ...

Page 11: ...the user s manual The fault finding described is only intended to identify boards modules or major components that need to be replaced This document is not intended as a full diagnostic tool because many of the boards and modules cannot be satisfactorily repaired in the field and must be returned to Huntleigh Healthcare if faulty If any warranty claim is intended then it is important to ensure tha...

Page 12: ... proceeding 4 1 1 Invert the unit and remove the battery cover by removing the securing screw using the Allen key provided 4 1 2 Lift the battery out and connect the battery to the unit 4 1 3 Replace the battery re fit the battery cover ensure that the air filter is still in place and replace the securing screw with the Allen key provided DO NOT OVERTIGHTEN The battery should now be conditioned by...

Page 13: ...s and pulse volume recording PVR volume plethysmography Ability is suitable for use in woundcare assessment for assessing symptomatic PAD and as a screening device for PAD It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy Dopplex Ability can be used on patients with unilateral lower limb amputation 5 1 Front panel connections and control...

Page 14: ...Product Description 771402 2 dopplex ABIlity Service Manual 14 5 3 Base 1 Battery Cover 2 Battery Cover Retaining Screw 3 Slide Plate Mounting Boss 4 Air Filter 5 4 Product Labelling ...

Page 15: ...Product Description 771402 2 dopplex ABIlity Service Manual 15 ...

Page 16: ... ABIlity Service Manual 16 5 5 User Interface User Set Up Options Menu Service Menu Map Exit Contrast Set Time Date Paper Type Audio Volume Classification Waveforms Language Battery Conditioner Service Menu Refer to User Service Menu Map ...

Page 17: ...ck Also tests overpressure sensor Cuff Leak Test Tests cuffs for leakage Record Service Enters Date of Service into memory Print Service Report Prints report using internal printer Test Printer Initiates a Test Printout Flow Test Tests for pneumatic integrity Hardware Monitor Checks function of independent timer ...

Page 18: ...edical equipment e g the PC or printer with enclosure leakage currents greater than those allowed by IEC601 1 EN60601 1 is to be used in the patient environment within 1 5m of the patient the enclosure leakage currents must be brought within the limits laid down by IEC601 1 EN60601 1 This may be achieved by using a medical grade isolating transformer Suitable types are available via Huntleigh sale...

Page 19: ...hip Solenoid Drivers Sensor Interface 5 0V 3 3V LED Backlight Control Buffer Level Shifter Printer I F Connectors for Cuffs Power path controller 6 0V Switcher Vcc 5 0V Switcher 1 8V Switcher En En En En En System power rails MCU PIC Isolated Area 5 0V 6 0V Mains Inlet Isolated Area 3 3V Switcher 5V PERM Lin Hardware monitor EEPROM I2C bus Printer PCB USB Connecor USB Isolator Bus or Port Control ...

Page 20: ...s analogue drive voltage required to operate the linear valves Digital POT Used to control the audio volume BOOST Used to step up the main PSU voltage to the level required for optimal battery charging Battery Charger Provides all the functions required for reliable charging and charge termination of the NiMH rechargeable battery Gas gauge The gas gauge monitors the battery state of charge and emp...

Page 21: ...ils 6 4 Front panel PCB assembly Buffer Level shifters Data bus interface to the LCD panel LED Backlight Control Interface for the software adjustable backlight control 15V Switcher LCD panel power source 6 5 Printer Interface PCB Handles control of the thermal print head and the stepper motor Communicates to the Base PCB Assembly via a high speed RS232 serial interface 6 6 Manifold assembly This ...

Page 22: ...System Block Diagram 771402 2 dopplex ABIlity Service Manual 22 6 7 Pneumatic Circuit Diagram ...

Page 23: ...System Block Diagram 771402 2 dopplex ABIlity Service Manual 23 ...

Page 24: ...System Block Diagram 771402 2 dopplex ABIlity Service Manual 24 ...

Page 25: ...off whilst the detect chamber is inflated to a constant lower pressure of 45 mmHg and used to monitor blood flow distal to the occlusion chamber By observing the small pressure changes in the detect cuff that relate to blood flow in the limb to which they are fitted the systolic blood pressure is determined The cuffs are designed to fit the arms and ankles and incorporate novel features to aid fit...

Page 26: ...lity for example if the patient moves excessively and reports the outcome at the end of the test 7 4 All detect chambers At the beginning of each test all chambers including occlusion chambers are inflated to 45 mmHg and maintained at this pressure for around ten seconds During this period the AC signals from the ankle occlude chamber pressure sensors is recorded This signal is referred to as the ...

Page 27: ...t 10 cycles in both Arms Legs Occlude Arms Deflate Arms Dump Arms Occlude L Leg Deflate L Leg Occlude R Leg Deflate R Leg Dump all leg cuffs R Arm Det L Arm Det Arm Bleed Arm Dump Pump Divert Pump L Leg Occ Det LL Bleed R Leg Occ Det RL Bleed Leg Dump Duration s 10 10 14 40 2 12 3 18 2 18 3 18 2 18 Fields markes are of 500ms All timings are approximate and vary between test subjects above based on...

Page 28: ...Ability provides valid ABI results for at least 80 of the patients tested Valid results consist of both compressible vessels where Dopplex Ability agrees with the Doppler method to 0 28 for the 95 limits of agreement and incompressible vessels PVR Dopplex Ability provides filtered PVR waveforms from the ankles with 3dB cut off frequencies at 0 35 Hz and 10 Hz Maximum Cuff Pressure 230 mmHg 8 3 Env...

Page 29: ...Product Specifications 771402 2 dopplex ABIlity Service Manual 29 8 4 General ...

Page 30: ...ismantle and re assemble the unit Note that all screws used are of the Pozidriv type and the correct type and size of screwdriver should be used Failure to use the correct screwdriver can result in damage to the tip of the screwdriver and to the head of the screw Table 1 Tools Tool Used On Screwdriver Pozidriv Size 1 M2 screws M3 screws and self tap screws Hex socket or nut spinner M2 4 mm AF Prin...

Page 31: ...Removal Remove the 3 off KB30x10 countersunk screws On Reassembly torque to 60cNm Remove the 2 off KB30x14 pan head screws On Reassembly torque to 60cNm Disconnect the 8 pieces of tubing from the front panel connectors Disconnect the display ribbon cable The case front has now been removed ...

Page 32: ...n head screw On reassembly torque to 25cNm Remove the Battery lid Air filter pad SP 771516 and unplug the Battery pack SP 771332 Remove the 2 off M3x8 countersunk screws On reassembly torque to 50cNm Remove the 2 off M3x12 pan head screws On reassembly torque to 60cNm Remove the 2 off KB30x14 pan head screws On Reassembly torque to 60cNm ...

Page 33: ...2 2 dopplex ABIlity Service Manual 33 Disconnect the Printer Power and Signal cables from the Base PCB Disconnect the IEC Mains Inlet and Earth cables from the Base PCB The case rear has now been removed Rear moulding SP 771319 ...

Page 34: ...ff M3x16 countersunk screws On reassembly torque to 90cNm Remove the 2 off KB30 10 pan head screws On reassembly torque to 60cNm Unplug the Battery cable from the PCB Unplug the tubing from the pump to the base Slide the Base PCB forwards so that it clears the 2 plastic locating tabs then lift off the Base PCB ...

Page 35: ...ble Carefully remove the faulty keypad from the Display panel Locate the new keypad over the Display panel Push the flexi cable FFC tail through the recess in the Display panel Remove the backing from the keypad When in position ensure all surfaces are in contact by pressing all edges firmly Plug in the keypad flexi cable and replace the foam tape ...

Page 36: ... R YELLOW connector SP 771339 Y REMOVAL Using the Long Nose pliers compress the locking tab of the Cuff connector then carefully push out that side of the connector Repeat this for the other side of the connector REPLACEMENT Insert the Cuff connector with the locating tab notch correctly orientated into the Front moulding then push the connector firmly until it is fully locked ...

Page 37: ...C MAINS INLET SP 771499 REPLACEMENT Using the long nose pliers compress the 2 locking tabs then carefully push out that side of the IEC Mains Inlet connector Repeat this for the locking tab on the other side of the IEC Mains Inlet connector IEC Mains Inlet cable SP 771501 ...

Page 38: ... Snap fit the new Printer door onto the Hinge pin Printer Roller SP 771536 Remove the existing roller by pulling out of the lugs in the door using fingers IMPORTANT Before fitting new roller ensure orientation is correct the cogged wheel is on the right side Snap fit one side of the new roller into the Printer door followed by the other side Printer door with roller attached ...

Page 39: ...rque to 40cNm To remove the Printer PCB Unplug the Printer mechanism flexi cable Unplug the Printer power cable Unplug the Printer signal cable Remove the 4 off M2 2x6 screws On reassembly torque to 45cNm NOTE ensure the Printer to Base PCB Signal cable is not trapped or crushed and is free moving Tie wrap both cables to the rear case boss Remove the M2 nut and shakeproof washer NOTE the position ...

Page 40: ...Unpack the Printer mechanism Remove the roller and protective paper from the printer mechanism Insert the Printer mechanism into the Printer carriage NOTE the alignment tab and pin Replace the 2 off M2 nuts crinkle washers and screws NOTE The M2x8 pan head screw is fitted next to the printer motor Locate the 3 tabs at the rear of the carriage with into position against the rear case before lowerin...

Page 41: ...vice Manual 41 When locating the carriage printhead assembly into position Take care not to dislodge the hinge pin 9 10 Fuse SP 771539 replacement Complete the CASE REAR removal Remove the fuse cover Remove the fuse Replace the fuse Replace the cover ...

Page 42: ...SE FRONT removal Complete the CASE REAR removal Unplug the PSU to Regulator PCB cable Remove the 2 off M3x5 screws and shakeproof washers On reassembly torque to 60cNm Unplug the Ferrite PCB Remove the 2 off M3x6 screws and shakeproof washers On reassembly torque to 60cNm Lift off the PSU module Remove the Ferrite PCB ...

Page 43: ...RONT removal Complete the CASE REAR removal Complete the PSU Module removal Using the M4 nut spinner remove the 4 nylon spacers On reassembly torque to 35cNm Carefully unplug the Regulator PCB from the Base PCB NOTE The orange Regulator PCB to Base PCB cable will still be connected Unplug the Regulator PCB to Base PCB cable ...

Page 44: ...the PCB Using solder braid clean out the two PCB holes IMPORTANT Note tubing connections before removing Unplug the two tubes from the pump Cut the two tie wraps and lift out pump Replacement Place new pump into position and secure using tie wraps Re connect tubing referring to notes made earlier Insert wires through holes in PCB see photo solder ...

Page 45: ...PCB Re fitting Cut wires to 25mm and prep tin ends to 5mm Secure the new valve in place using the screws torque to 60cNm Re fit wires into holes and re solder Reconnect tubes referring to notes made earlier 9 15 Solenoid Valve SP 771585 Replacement IMPORTANT Note tubing connections before removal Disconnect tubes from valve to be replaced Desolder the 2 pins and remove the valve Using solder braid...

Page 46: ... 46 9 16 Over Pressure PCB SP 771507 Replacement Desolder the 8 pins of the Over pressure PCB Using solder braid clean out the 8 PCB holes Put the Overpressure Detect PCB in place with the unpopulated side towards the pump Solder in place using lead free solder ...

Page 47: ... the CASE FRONT removal Complete the CASE REAR removal Complete the BASE removal Complete the PSU Module removal Complete the Regulator PCB removal Complete the Manifold removal Reuse the 4 metal Regulator PCB spacers M3x8 screws and shakeproof washers on the replacement Base PCB On Reassembly torque to 65cNm ...

Page 48: ...oval Complete the CASE REAR removal Complete the BASE removal Unplug the 7 tubes shown Remove the M3x8 screw and shakeproof washer securing the Manifold to the Base PCB On Reassembly torque to 20cNm Using the Long Nose pliers compress the locking tab of the PCB spacer then carefully pull off the PCB Repeat for the other spacer ...

Page 49: ...Disassembly Assembly 771402 2 dopplex ABIlity Service Manual 49 Unplug the 4 tubes from the valves The manifold with its tubing has now been removed ...

Page 50: ...Complete the BASE removal Complete the MANIFOLD removal NOTE When handling batteries ensure Gloves are worn Do NOT handle batteries with bare hands Remove the battery from the battery holder on the Base PCB When replacing the battery ensure the positive terminal marked with a is facing upwards Finally re assemble the unit switch on and set the unit to the correct time and date ...

Page 51: ...te that Dielectric strength testing as per clause 20 of EN60601 1 is carried out before the units leave the factory These Dielectric strength tests must not be repeated in the field This is because repeated Dielectric strength tests may degrade the insulation 10 2 Electrical Safety Test Mains Inlet to Enclosure Leakage Current 10 2 1 Connect the unit under test as illustrated below to a suitable e...

Page 52: ...below to a suitable electrical safety analyser 10 3 2 Switch on the unit 10 3 3 Allow the unit to fully initialise before applying the tests in the table below Test Test Limit Normal Polarity 100μA No L2 500μA Reversed Polarity 100μA No L2 500μA Live Earth Neutral Neutral from Analyser Earth from Analyser Live from Analyser Enclosure Socket of Analyser USB Socket ...

Page 53: ...elow to a suitable electrical safety analyser 10 4 2 Switch on the unit 10 4 3 Allow the unit to fully initialise before applying the tests in the table below Test Test Limit Normal Polarity 100μA No L2 500μA Reversed Polarity 100μA No L2 500μA Open the printer Live Earth Neutral Neutral from Analyser Earth from Analyser Live from Analyser Enclosure Socket of Analyser ...

Page 54: ...rvice report is shown below Dopplex Ability Service Report Model DA100PB Date 2015 11 17 Time 10 23 Service History 2015 11 17 2015 05 17 2014 05 17 2013 05 17 2012 05 17 2011 11 17 HUNTLEIGH 11 2 Air Filter Replacement To replace the air filter disconnect the unit from the mains supply invert it and remove the single screw securing the battery cover Lift out the cover and remove the circular air ...

Page 55: ...tery conditioning Battery conditioning will take 8 to 10 hours 11 3 6 If Battery Conditioner is selected when mains line power is not connected the following message is displayed 11 4 Cuffs The overall condition of the cuffs should be assessed checking the following areas carefully Any physical damage to the cuff material Legibility of the labeling Integrity of the cuff tubing Condition of the con...

Page 56: ...the sealing O rings Display window LCD All areas of the enclosure Mains Inlet connector for condition security USB socket Printer paper tray 11 6 Real Time Clock Battery Check The internal real time clock is maintained by a replaceable Lithium ion coin cell This battery can be expected to last for at least five years If time and date storage becomes unreliable it should be replaced For battery rep...

Page 57: ... press accept tick 5 Connect the test bottles to the right arm cuff connector red 6 Connect the blanking plug to the left arm cuff connector yellow 7 Press start the flow test will begin 8 When prompted by the display move the test bottles to the left arm cuff connector yellow and the blanking plug to the right arm cuff connector red 9 Press start the flow test will continue 10 When prompted by th...

Page 58: ...ration Note that pressures of greater than 350mHg should not be used As long term drift of the pressure sensor offset and gain may occur it is recommended that calibration is performed at every service Once calibrated pressure accuracy is specified as 3 mmHg over the range 0 to 250 mmHg An independent overpressure sensor is included in the unit to ensure the air pressure in the system never exceed...

Page 59: ...he softkeys enter the PIN code 5315 The Service Menu will then be displayed 6 Scroll to Calibration and press the centre soft key 7 Ensure the valve on the sphygmomanometer is open and that 0 mmHg is highlighted on the screen and press the centre soft key to set the zero 8 After about 5 seconds when the highlight on the screen moves to 250 mmHg close the sphygmomanometer valve and squeeze the bulb...

Page 60: ...Utility This software program can be downloaded from the Internet please contact the Service Department for the link Cardiff service huntleigh diagnostics co uk To determine the installed software version switch the unit on and view the first screen displayed dopplex ABIlity Duo Sense Technology The software version is displayed at the lower right hand side of this screen 13 1 Upgrade Utility User...

Page 61: ...ility you should see the program connect to the Internet Huntleigh cloud and download the latest application software for the Ability unit 6 Enter your e mail address in the Email box and click on the Read SN button If the serial number cannot be read automatically from the unit then type the serial number located on the base of the Ability unit into the box 7 Click on the Start Upgrade button in ...

Page 62: ...o the computer and press the on off button The following screen should be displayed 4 Start the dopplex Ability Upgrade Utility by clicking on the desktop icon 5 Click the Read SN button and make a note of the COM number shown on the status window during this process 6 When the serial number has been retrieved press and hold the ALT key and then press the Z key 7 Enter the PIN code given for the u...

Page 63: ...e the centre key the pressing of which returns the user to the main screen and no test results are provided 14 2 1 Check Cuffs This message is displayed when a leak is detected during the early stages of the test The leak detection is only active after the initial inflation and top up during the PVR waveform collection stage highlighted in Figure 1 Timing of Leak Detection Although this fault can ...

Page 64: ...e with white background Source of Leak Cuff Chamber Source Displayed Right Ankle Detect Right Ankle Cuff Occlusion Left Ankle Detect Left Ankle Cuff Occlusion Right Arm Detect Right Arm Cuff Occlusion Arm Cuffs Left Arm Detect Left Arm Cuff Occlusion Arm Cuffs Table 2 Leak Detection Sources and Resulting Messages ...

Page 65: ...s Figure 2 Inflation Detection Timing inflation periods shown in areas with white background In practice the actual pressure will not exactly match the calculated ideal so limits must be provided to allow for this difference and at the same time be of suitable magnitude to avoid nuisance triggering these upper and lower limits of 30 mmHg forming an acceptable envelope of pressure as illustrated in...

Page 66: ...Fault Modes 771402 2 dopplex ABIlity Service Manual 66 Figure 3 Inflation Envelope ...

Page 67: ...Figure 4 by checking the pressure in each of the cuffs at the point eight seconds after inflation begins If the pressure fails to reach 10 mmHg in this time the fault cuffs not connected is generated The arm and ankle cuff bi lateral pairs are inflated separately and during the initial inflation all chambers of the pair are pneumatically connected so the detection of which cuff is missing is not p...

Page 68: ...ains open during an occlusion inflation resulting in occlusion pressures reaching the non isolated detect chamber 14 2 5 Cannot Measure This fault is generated at the end of the test if both of the ankle signals collected from the patient exhibit excessive noise or do not fit the expected response This is often the result of patient movement and or poor positioning of the patient The user should b...

Page 69: ... Array Full Fault NOTE 1 011 Hard Stack Full Fault NOTE 1 012 Hard CPLD Trigger Fault 013 Soft CPLD Pre Trigger Capture 014 Hard Memory Access Fault 015 Hard Electro mechanical Supply Failure 14 3 1 Internal Fault 001 Soft I 2 C Sounder Failure An attempt to write to the sounder volume digital potentiometer has failed twice This is a non critical fault and the unit will continue to operate with po...

Page 70: ...ithin acceptable limits The functionality of the battery charger has been compromised by voltage fluctuations present on the applicable supply rails This condition is non recoverable and the unit must be powered down mains power cycled and the unit restarted At present there is no method of determining which of the above faults has occurred however with the unit powered by the mains supply normal ...

Page 71: ...d the current test has exceeded 4 minutes in length or if the test has entered a second phase of inflation the second phase has exceeded 4 minutes in length At this point the electromechanical supply has been de activated which allows all cuffs to vent and the unit operation halts pending a reboot following a 30 second CPLD timed period 14 3 13 Internal Fault 013 Hard CPLD Pre Trigger Capture The ...

Page 72: ... unit and date of purchase if known This information is in addition to the circuit reference and the reference number and issue of the PCB required Items returned for replacement under guarantee should be labeled with the unit type serial number date of purchase if known and written details of the symptoms or fault found Orders for spare parts may be sent by post fax or telephoned to Huntleigh Hea...

Page 73: ...S SP 771541 Ability Calibration Adapter Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Road Cardiff CF24 5HN United Kingdom T 44 0 29 20485885 F 44 0 29 20492520 E sales huntleigh diagnostics co uk W www huntleigh diagnostics com Registered No 942245 England Wales Registered Office ArjoHuntleigh House Houghton Hall Business Park Houghton Regis Bedfordshire LU5 5XF Huntleigh H...

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