Arthrex AR-3200-0020 Скачать руководство пользователя страница 56

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950-0047-04A

Page 56 of 69

4.0

Technical Information

NOTE: Technical data is subject to modification, revision and improvement without notice.

Safety, EMC and Regulatory Requirements

Parameter

Parameter Value

System Classification

FDA Class

Class II

EU Class

Class I

Health Canada Class

Class II

Safety Certifications

Domestic Certification

•

ANSI/AAMI ES60601-1/A1:2012

Canadian Certification

•

CAN/CSA-C22.2 No. 601.1-M90

•

CAN/CSA-C22.2 No. 60601-1:2014

EU Certification

•

ANSI/AAMI ES60601-1/A1:2012

•

IEC 60601-1:2005 + Corrigendum
1:2006 + Corrigendum 2:2007 +
AM1:2012 [IEC 60601-1:2012]

EMC Certifications

CISPR 11 EMC Class

Class A

CISPR 11 EMC Group

Group 1 [RF internally generated for the
operation of the device]

EMC Certification

Certification to IEC 60601-1-2:2014 Class A

Safety Certification
Marking

CE Marking

CE Marking for MDD 93/42/EEC, RoHS 2011/65/EU, and
(RED)(2014/53/EU)

Содержание AR-3200-0020

Страница 1: ...Unit and Camera Head User s Guide provides important information for the safe operation of all components of the SynergyUHD4 Camera System including accessories Read this User s Guide thoroughly prior to using this system and keep it in an easily accessible place for use by all operating personnel Read and follow all safety warnings cautions and precautions Arthrex Inc 1370 Creekside Blvd Naples F...

Страница 2: ... For all warranty information including disclaimers exclusions terms conditions and related provisions refer to the Arthrex U S Product Warranty section of the Arthrex Inc website found at www arthrex com whose provisions are incorporated herein by reference ...

Страница 3: ...ation 20 2 2 Accessories for Intended Use 22 2 3 System Setup Facility and Surgeon Settings 24 2 4 Icon Guide 33 2 5 Scheduling and Starting Cases 35 2 6 Status Notification Icons 42 2 7 System Operation without Tablet Data Input Device 45 3 0 Maintenance 47 3 1 Life Expectancy 47 3 2 Periodic Maintenance 47 3 3 Cleaning and Sterilizing 48 3 4 Troubleshooting 52 3 5 Resolving Error Messages 55 3 6...

Страница 4: ...OTE AR 3200 0020 AR 3200 0022 SynergyUHD4 Consoles or Camera Control Units CCU are identical to AR 3200 0021 AR 3200 0023 CCUs except that AR 3200 0020 AR 3200 0022 incorporate the Matrix PWA for transmission of UHD4 data by fiber optic 1 1 Intended Use This system is designed for use by physicians and surgeons and is intended for endoscopic camera use in a variety of endoscopic surgical procedure...

Страница 5: ...r s accessories and replacement parts Use of other parts or materials may degrade safety 8 Do not use in the presence of flammable anesthetics gases disinfecting agents cleaning solutions or any material susceptible to ignition due to electrical sparking 9 Equipment grounding is vital for safe operation Plug the power cord into a properly earthed mains supply outlet whose voltage and frequency cha...

Страница 6: ...era Control Unit CCU and the endoscope rise during use Potential thermal injury to the patient s tissue and skin may result from prolonged exposure to the intense illumination in small cavities or if the endoscope s distal end is placed in close proximity with the tissue This can cause the temperature of the body tissue to rise in excess of 106 F 41 C Burns or thermal damage to surgical equipment ...

Страница 7: ...lable on request circuit diagrams component part lists descriptions calibration instructions and other information required for service to any Arthrex Authorized Service Center 5 This device should only be used in compliance with its intended use 6 Prior to each use the CCU and all associated equipment must be inspected for proper operation Visually inspect lenses to ensure there are no scratches ...

Страница 8: ...gned to provide reasonable protection against harmful interference in a typical medical installation This equipment generates and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other device s in the vicinity However there is no guarantee that interference will not occur in a particular installation If this equi...

Страница 9: ...mmable Anesthetics ON OFF Push Push USB Tablet Computer Connection Attention Consult Accompanying Documents Fragile Precaution of Warning Notice This Side Up Defibrillation Proof Type CF Equipment Keep Dry Electrical Hazard Dangerous Voltages are Present Never attempt to repair the equipment Only Trained Service Personnel may remove the cover or obtain access to system components Temperature Limit...

Страница 10: ...d Transport Equipotential Equipment Potential Universal Serial Bus WEEE Waste Electronics and Electrical Equipment Symbol Regarding European Union End of Life of Product RF Symbol Non ionizing Electromagnetic Radiation White Balance Symbol Color Video Camera LED Light Do Not Use if Damaged MFi Made for iPad EC Rep Catalog Number Serial Number ...

Страница 11: ...s contain Perchlorate Material special handling may apply See www dtsc ca gov HazardousWaste Perchlorate In the US a list of recyclers in your area can be found at www eiae org 1 6 Initial Use of the Device WARNINGS 1 The device is only completely isolated from the mains if the power plug is disconnected from the device s power inlet module Avoid positioning equipment such that removal of plug is ...

Страница 12: ...If it becomes necessary to return the device always use the original packaging The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport packaging Please make sure that all required information has been supplied Call Arthrex for an RMA Number for the device return for service Owner s Name Owner s Address Owner ...

Страница 13: ...t Guide 3 USB Port Connect USB devices here 4 iPAD USB Port Connect iPAD to this port 5 WHITE BALANCE Button Press to initiate camera white balance 6 CAMERA Input Connection Insert the camera head connector here The camera head connector and receptacle are specially keyed to prevent the camera head from being improperly connected Ensure that the UP label on the camera head connector is facing upwa...

Страница 14: ...ta Input device Provides for data interchange and tablet charging 10 Synergy Matrix Synergy Matrix Only Fiber Optic output to Matrix Monitor point to point or managed via Custom SFP Fiber Transceivers Use Output 1 and 2 for 4K Video Custom SFP Fiber Transceivers and Matrix License may be obtained from Arthrex Customer Service 11 3G SDI Out 1080P 60 Output 12 Ethernet Connector Isolated 10 100 Mb s...

Страница 15: ...950 0047 04A Page 15 of 69 Figure 3 AR 3210 0023 4K SynergyUHD4 Camera Head autoclavable Figure 4 AR 3210 0029 4K SynergyUHD4 Broadband Camera Head autoclavable ...

Страница 16: ...that can activate various functions of the camera See Optional Tablet Data Input Device for programming information 2 Button 2 A programmable button that can activate various functions of the camera See Optional Tablet Data Input Device for programming information 3 Focus Ring Used to sharpen or bring into focus the image detail 4 Grasping Mechanism Accepts and locks into place the compatible scop...

Страница 17: ...Mount Camera Head autoclavable AR 3210 0028 4K SynergyUHD4 C Mount w 20 foot cable autoclavable and Not Pictured AR 3210 0026 4K SynergyUHD4 C Mount Camera Head 0 Degree autoclavable 1 2 3 Figure 8 AR 3210 0030 4K SynergyUHD4 C Mount Broadband Camera Head autoclavable ...

Страница 18: ...rgyUHD4 C Mount Camera Head autoclavable 1 9 4 C Mount Camera Heads 1 Button 1 A programmable button that can activate various functions of the camera See Optional Tablet Data Input Device for programming information 2 Button 2 A programmable button that can activate various functions of the camera See Optional Tablet Data Input Device for programming information 3 C Mount Threads Accepts standard...

Страница 19: ...splay Camera Head Compatible SynergyUHD4 Firmware Version AR 3210 0029 850 0026 01 A or higher AR 3210 0030 850 0026 01 A or higher AR 3210 0031 850 0026 02 B or higher AR 3210 0032 850 0026 02 B or higher All other camera head models mentioned in this IFU All versions Determining the Firmware Version of the SynergyUHD4 System Firmware can be verified on the About screen which is accessed by doubl...

Страница 20: ...nergyUHD4 to the primary surgical monitor via multiple output types e g Display Port and DVI Display Port and 3G SDI in the event that one type of connection is lost 5 If using a printer connect the printer cable to the USB connector on the rear panel of the SynergyUHD4 CCU Connect the other end of printer cable to the printer 6 Plug the AC power cord into the SynergyUHD4 power inlet module and a ...

Страница 21: ...950 0047 04 Rev A English 950 0047 01A Page 21 of 69 Figure 12 SynergyUHD4 Typical Interconnect Diagram With OPTIONAL Digital Documentation Tablet Integrated Optics Heads ...

Страница 22: ...essories Part Number Description AR 3250 XXXX Arthrex Monitors SONY UP PR80MD SONY UP PR80MD with UP DR80MD NKIT Medical Grade Printers AR 3350 XXXX AR 3351 XXXX AR 3352 XXXX AR 3355 XXXX Arthrex Arthroscopes Arthrex Laparoscopes Arthrex Hi Mag Laparoscopes Arthrex C Mount Arthroscopes AR 3200 1007 AR 3200 1013 SynergyUHD4 Synergy Documentation Tablet ...

Страница 23: ...20 AR 3200 1030 1034 1036 1042 1043 1044 1045 1046 1047 1049 BioOptico Licenses DICOM Licenses Synergy net Licenses AR 3210 XXXX AR 3200 1010 1012 AR 3200 1040 AR 3370 0006 AR 3370 0008 Arthrex C mount couplers Arthrex encrypted USB sticks Arthrex Synergy System Integration Cable Kit Arthrex Starfish Arthrex C Mount Starfish AR 3201 1005 Video Input Output 1080P Converter AR 3240 XXXX Arthrex Ligh...

Страница 24: ...gyUHD4 s Tablet Data Input Device Screens may appear slightly different than those shown in this document depending on the particular features enabled on SynergyUHD4 Figure 14 System Maintenance 2 3 1 System Set Up can be accessed by pressing the Maintenance Icon on the SynergyUHD4 Tablet Data Input Device and then selecting Advanced Settings ...

Страница 25: ...al facility preferences to be setup User can input the facility name associated with that specific SynergyUHD4 User can select the language used with SynergyUHD4 User can select number of cases saved to system before data is automatically purged Other configuration options are also available to users ...

Страница 26: ...age 26 of 69 Figure 16 Date Time Screen 2 3 3 Selecting Date Time enables adjustment of the SynergyUHD4 date and time settings User can use a network time server or user can select the date and time options manually ...

Страница 27: ...Page 27 of 69 Figure 17 Print Settings Screen 2 3 4 Selecting Print Settings enables adjustment of the SynergyUHD4 print settings User can enable the use of a local printer and select the paper size for that printer ...

Страница 28: ...allows for connecting the SynergyUHD4 system to a facility network Fields are Ethernet IP Mode Host Name Ethernet IP Address Ethernet Subnet Mask Ethernet Default Gateway Note If DHCP option is selected then the Ethernet address is acquired automatically and no fields need to be completed ...

Страница 29: ...ynergyUHD4 Tablet Data Input Device and then select Surgeon Management A list of surgeons will appear 2 3 8 To add a surgeon press the Add New Surgeon button enter the first and last name of a surgeon then press the Preferences button Note When a new surgeon is created it will automatically inherit all of the procedures and preferences associated with the default Surgeon account Figure 20 Surgeon ...

Страница 30: ...eon Preferences Settings 2 3 9 Surgeon preferences can be defined for the following Camera Button Settings Printer Settings Print Settings Multimedia Web Server Access Display BioOptico Note BioOptico is optional functionality for SynergyUHD4 ...

Страница 31: ...dividual surgeon preferences On the surgeon management list select a surgeon and a list of procedures will appear 2 3 11 Select the appropriate Procedure for the Surgeon If the procedure is not currently in the list select the Create New Procedure from the Procedures drop down list and enter the name of the new procedure ...

Страница 32: ...e 32 of 69 Figure 23 Surgeon Procedure Settings 2 3 12 Once a Procedure has been added select the Procedure Settings next to the Procedure name to configure camera pump and shaver settings associated with the Procedure ...

Страница 33: ...he lower left corner of the screen are icons that represent connectivity with SynergyUHD4 The icons shown below represent tablet network and Synergy net connectivity 2 4 3 The icons on the lower right of the monitor represent local and external peripheral connectivity e g printer USB iPad DICOM network export as shown in the figures below Printer USB iPad DICOM Network Synergy net ...

Страница 34: ...not connected to SynergyUHD4 2 4 5 A yellow status bar event should be investigated prior to the start of a case as data transfers may not occur to any device where connectivity with SynergyUHD4 has not been established or has been lost 2 4 6 Once a case is started a smaller subset of connectivity icons will appear in the lower right corner of the surgical monitor These status icons represent conn...

Страница 35: ...950 0047 04A Page 35 of 69 2 5 Scheduling and Starting Cases Figure 25 Scheduling a case 2 5 1 To schedule a case press the Add New Case icon ...

Страница 36: ...esent optional field depending on how system is configured Surgeon and or Procedure and enter data in the following required fields Patient First Name Patient Last Name Patient I D 2 5 3 Input any of the other optional data elements in the appropriate fields 2 5 4 Press the Save icon ...

Страница 37: ...igure 27 Starting a Case 2 5 5 To start a case select the case patient from the Case List and press the Start icon NOTE Cases may also be started from the Add Case screen by entering the required fields and pressing the Start icon ...

Страница 38: ...950 0047 04A Page 38 of 69 Figure 28 Confirming a Case 2 5 6 A Case Confirmation window will appear showing the patient and case demographics If the information is correct press the Start icon ...

Страница 39: ... 69 Figure 29 Camera Head Button Change During Case 2 5 7 Changes to SETTINGS may be made during the procedure by pressing the Maintenance Icon Changes may be made to the following Camera Head Button Functions Print Settings ...

Страница 40: ...950 0047 04A Page 40 of 69 Figure 30 Print Changes During Case ...

Страница 41: ...ding a Case 2 5 8 Ending a Case to end a case press the End Case Icon NOTE An End the Case confirmation message will appear If confirmed the case will end and the SynergyUHD4 Tablet Data Input Device will transition to the case review screen ...

Страница 42: ... 6 1 When a manual export print is performed the status notification for the action will appear on the tablet The blue progression bar will indicate that the export is in progress Once the export is complete the status bar will turn green Green arrows for each image indicate a successful export ...

Страница 43: ...950 0047 04A Page 43 of 69 Figure 33 Export Status 2 6 2 The system in Figure 33 displays a successful USB export and an iPad export in progress ...

Страница 44: ...led for the surgeon using the system A successful export will display a green checkmark for the images completed A failure will be displayed by a yellow caution triangle Note Print statuses are not reflected in the individual image status icons The external devices statuses and connectivity status will also be displayed during the case in the lower right corner of the tablet ...

Страница 45: ...ness 6 Long Press on the RIGHT BUTTON will control Digital Zoom After a LONG PRESS on the RIGHT BUTTON pressing the RIGHT Button will INCREASE ZOOM After a LONG PRESS on the RIGHT BUTTON pressing the LEFT Button will DECREASE ZOOM 7 The SynergyUHD4 Initial Screen will also indicate that the Printer is Active and that it is set to 8 prints per page 8 The center screen of the SynergyUHD4 Initial Scr...

Страница 46: ...n successful the camera will enter the Surgical Ready Mode and be ready for surgical operation 14 If the White Balance Operation has not been successful you must move the Tip of the Endoscope closer or farther from the White Gauze until the operation can be completed successfully 15 Once the White Balance Operation has been successfully completed the Camera Head buttons will function as defined on...

Страница 47: ...the most knowledgeable about the Arthrex Medical Camera Systems and or camera heads and will provide competent and efficient service Any services and or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure 3 1 Life Expectancy Life expectancy for the product is expected to meet and exceed the warranty period for approximately 5 ...

Страница 48: ...required 6 Allow to AIR DRY for 5 minutes prior to use 3 3 2 Cleaning the Camera Control Unit CCU 1 Turn the CCU power off Disconnect the power cord from the electrical power source and from the rear of the CCU 2 Remove the camera head from the CCU 3 Wipe the CCU with a clean soft cloth dampened with a mild pH balanced detergent 4 Wipe the CCU again with a clean soft cloth dampened with Tap or ste...

Страница 49: ...h other instruments 3 Do not overload the washer 4 Remove the camera heads immediately after the automatic procedure has stopped 5 Set up and run washer for the wash cycle listed below Automatic Washer Cycle Definition Phase Recirculation Time Minutes Temperature Detergent Type and Concentration Pre Wash 1 02 00 COLD TAP WATER NA Enzyme Wash 03 00 HOT TAP WATER Enzol 1oz gallon Rinse 1 00 15 HOT T...

Страница 50: ...removed 6 Visually inspect the camera head for visible soil and remove if required 7 Dry the equipment with a lint free soft cloth Wipe the card edge connector with 70 isopropyl alcohol to remove any residual detergent a Do not allow exposed glass windows to air dry 70 isopropyl alcohol may be applied to glass surfaces with a soft cotton applicator to prevent streaks and spots Dry the surfaces tho...

Страница 51: ...rilization System Lumen and Non lumen Cycles Sterrad Systems Sterrad System 100S Short Cycle Sterrad System NX Short Cycle Sterrad System 100NX Standard Cycle 3 3 6 Material Compatibility In addition to the Sterilization chemicals listed above the AR 3210 XXXX camera heads are Material Compatible with Cidex OPA No SAL claims are made with Cidex OPA WARNING Use of Sterilants or Chemicals other than...

Страница 52: ...es If picture is affected inspect cables and replace as necessary Flex camera cable If picture is affected return to factory for repair or replacement Camera will not white balance Too much light Too little light Wrong Color Temperature light If monitor indicates White Balance Fail move the scope further away from the white gauze when you white balance or turn down the LED Light Engine brightness ...

Страница 53: ...n monitor If image is now viewed the original camera head and or cable were faulty return them to Arthrex for repair Insert camera head cable connector completely into the CCU s camera head receptacle on the front panel Check monitor using color bars from the CCU Try the CCU on a different monitor Poor color reproduction White Balance Issues White Balance camera head Check monitor settings using c...

Страница 54: ...ector are not damaged If damaged contact Arthrex Technical Support for further assistance Ensure charger is a Samsung mode EP TA10JWE that has a minimum of 2 0A of charge current Replace charger if it is not Contact Arthrex Technical Support if problem persists Ensure USB charger cable is a USB 3 0 cable both connectors with a length that does not exceed 6 ft 1 83 meters Replace charger cable if i...

Страница 55: ... were unable to restore the following items and they have been reset back to their default values Contact Arthrex Technical Support for further assistance An error occurred while fetching version info Contact Arthrex Technical Support for further assistance The Synergy console cannot be reached Contact Arthrex Technical Support for further assistance Failed to install updated controller Contact Ar...

Страница 56: ...tion ANSI AAMI ES60601 1 A1 2012 Canadian Certification CAN CSA C22 2 No 601 1 M90 CAN CSA C22 2 No 60601 1 2014 EU Certification ANSI AAMI ES60601 1 A1 2012 IEC 60601 1 2005 Corrigendum 1 2006 Corrigendum 2 2007 AM1 2012 IEC 60601 1 2012 EMC Certifications CISPR 11 EMC Class Class A CISPR 11 EMC Group Group 1 RF internally generated for the operation of the device EMC Certification Certification ...

Страница 57: ...ording to the mode of operation Continuous Specifications Parameter Parameter Value Power Requirements Rated Voltage 100 240 VAC Supply Frequency 50 60 Hz Power Input 160 VA Fuses No user serviceable fuses Video Outputs Video Output Description Display Port 2x 3840 x 2160 pixels 4K UHD 10 bit color DVI 2x 1920 x 1080 pixels 1080p 8 bit color 3G SDI 4x 1920 x 1080 pixels 1080p 8 bit color Matrix Vi...

Страница 58: ...m H AR 3210 0025 Approximately 2 8 L x 1 65 W x 1 7 H 7 1 cm L x 4 2 cm W x 4 3 cm H AR 3210 0026 Approximately 2 9 L x 1 2 W x 1 3 H 7 3 cm L x 3 0 cm W x 3 3 cm H AR 3210 0028 Approximately 2 8 L x 1 65 W x 1 7 H 7 1 cm L x 4 2 cm W x 4 3 cm H AR 3210 0029 Approximately 4 1 L x 1 8 W x 1 8 H 9 9 cm L x 4 6 cm W x 4 6 cm H AR 3210 0030 Approximately 2 8 L x 1 65 W x 1 7 H 7 1 cm L x 4 2 cm W x 4 ...

Страница 59: ...0 0028 Approximately 27 4 ounces 0 8 kg AR 3210 0029 Approximately 21 0 ounces 0 6 kg AR 3210 0030 Approximately 17 4 ounces 0 5 kg AR 3210 0031 Approximately 20 8 ounces 0 6 kg AR 3210 0032 Approximately 17 5 ounces 0 5 kg Transport Storage Conditions Ambient Temperature 40 F to 122 F 40 C to 50 C Relative Humidity 10 to 90 non condensing Atmospheric Pressure 500 hPa to 1060 hPa Operating Conditi...

Страница 60: ... Lumens Typical 1800 Lumens HCRI Minimum 1000 Lumens Typical 1125 Lumens Color Temp Standard 70 CRI Typical 65 Minimum 5500 8500K HCRI 92 CRI Typical 90 Minimum 5200 6700K LED Life 30 000 hours Light Guide Port Turret ACMI Standard Storz Wolf and Olympus DICOM Specifications DICOM Statement DICOM Compatible with installation of AR 3200 1020 DICOM Key ...

Страница 61: ...ndesired operation CAUTION changes or modifications not expressly approved by Arthrex will void the user s authority to operate this equipment Industry Canada Information Contains IC 4104A AR5B225 IC Model AR5B225 This device complies with Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this d...

Страница 62: ...al provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the Electro magnetic Environment of use and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing other Equipment and Systems or non medical electrical equipment NOTE Medical Electrical Equipment...

Страница 63: ...directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re ...

Страница 64: ...e 2 kV common mode Mains power should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 UT 0 0 5 cycle 0 45 90 135 180 225 270 and 3150 UT 0 1 cycle UT 70 25 30 cycles 0 degrees UT 70 250 300 cycles UT 0 0 5 cycle 0 45 90 135 180 225 270 and 3150 UT 0 1 cycle UT 70 25 30 cycles 0 degrees UT 70 ...

Страница 65: ...hs from fixed RF transmitters as determined by an electromagnetic site survey a should be less that the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked 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 absor...

Страница 66: ...imum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz P E d 1 5 3 800 MHz to 2 7 GHz P E d 1 7 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 14 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated ...

Страница 67: ... SW Version access ACCESS to SW Version on Synergy UHD4 1 On POWER ON the screen below appears 2 Double click on screen to pull up SW Version 3 Then Tap About Figure 34 Logging on to Android Figure 35 About Screen Figure 36 SW Version Screen ...

Страница 68: ...950 0047 04A Page 68 of 69 THIS PAGE INTENTIONALLY LEFT BLANK ...

Страница 69: ...Customer Service 1 800 934 4404 Arthrex Inc Toll Free Technical Support 1 800 391 8599 Monday through Friday 8 00 AM 8 00 PM ET www arthrex com Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany 49 89 909005 0 All rights reserved Printed in USA ...

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