Arthrex AR-3200-0020 Service Manual Download Page 32 | Manualshive

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950-0073-00 B SM, English, Arthrex Synergy UHD4 System

32 of 74

Figure 11 - 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.

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Summary of Contents for AR-3200-0020

Page 1: ...rvice Manual provides important information for the safe operation and service of all components of the Synergy UHD4 Camera System including accessories Read this Service Manual 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 FL 3410...

Page 2: ... warranty document 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 ...

Page 3: ...t Device 20 2 1 Installation 20 2 2 Accessories for Intended Use 22 2 3 System Setup Facility and Surgeon Settings 24 2 4 Scheduling and Starting Cases 33 2 5 System Operation without Tablet Data Input Device 40 3 0 Theory of Operation 42 3 1 SCOPE 43 3 2 GENERAL DESIGN GOALS 43 3 3 CAMERA CONTROL UNIT 44 3 4 MOTHERBOARD 46 3 5 ISOLATION BOARD 46 3 6 CAMERA HEAD 47 3 7 PROGRAMMING 49 4 0 Maintenan...

Page 4: ...Arthrex Synergy UHD4 System 4 of 74 5 0 Troubleshooting Tests 57 5 1 Procedure 57 6 0 Technical Information 61 7 0 APPENDIX Radio Module Information 66 8 0 APPENDIX Detailed EMC Information 67 9 0 APPENDIX SW Version access 72 ...

Page 5: ...ystem is designed for use by physicians and surgeons and is intended for endoscopic camera use in a variety of endoscopic surgical procedures including but not limited to orthopedic laparoscopic urologic sinuscopic and plastic surgical procedures It is also intended to be used as an accessory for microscopic surgery 1 2 Contraindications Do not use the device if endoscopic surgery is contraindicat...

Page 6: ...he patient prior to applying cardiac defibrillation to patient 5 Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated The physician must determine the specific technique and procedure that will accomplish the desired clinical effect 6 This device and its accessories are to be used only by physicians and medical assista...

Page 7: ...the product is contaminated 18 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 orienting or relocating the Synergy UHD4 Video System or shielding the location 19 NOT for use in an Oxygen Rich Environment 20 Applied...

Page 8: ...e protective glasses designed for the laser s wavelength To prevent damage to the Endoscope the Laser should be activated only after the tip of the laser can be seen thought the endoscope 28 To ensure FCC RF Exposure limits for base station transmissions devices is met a distance of 20 cm or more shall be maintained between the Camera Control Unit which contains the antennas and persons during ope...

Page 9: ... head to Arthrex for service disinfect the camera head before shipping and reference Returning the Device 14 Store camera head and all accessories in a protective container to prevent damage during storage Do not store CCU where it will be exposed to temperatures in excess of 140 F 60 C 15 Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO sta...

Page 10: ...This unit was not evaluated for use with electrosurgical devices which access the site via the same endoscope as the light source and camera The unit must be re evaluated prior to use with electrosurgical devices when they will operate through the same endoscope as the light source and camera 18 After each use thoroughly clean unit and accessories See Cleaning and Sterilizing NOTES 1 Observe all n...

Page 11: ...he Presence of Flammable 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...

Page 12: ...round Humidity Limits for Storage and 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 ...

Page 13: ...ent Lithium Batteries 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...

Page 14: ...rning the Device 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 a RMA Number for the device return for service Owner s Name Owner ...

Page 15: ...DICATOR then Insert Light 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 ...

Page 16: ...ction for Tablet Data 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 I...

Page 17: ...950 0073 00 B SM English Arthrex Synergy UHD4 System 17 of 74 Figure 3 AR 3210 0023 4K SynergyUHD4 Camera Head autoclavable Figure 4 AR 3210 0029 HD SynergyUHD4 Broadband Camera Head autoclavable ...

Page 18: ...rious 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 scope DIN 58105 complian...

Page 19: ...rgyUHD4 C Mount Camera Head autoclavable and Not Pictured AR 3210 0022 HD SynergyUHD4 C Mount Camera Head 0 Degree 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 15 Button 2 A programmable button that can activate various functions of the camera See Optional...

Page 20: ...e used instead of Display Port cables Note Arthrex recommends connecting Synergy UHD4 CCU 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 Synergy UHD4 CCU Connect the other end of printer cable to th...

Page 21: ...950 0073 00 B SM English Arthrex Synergy UHD4 System 21 of 74 Figure 8 Synergy UHD4 Typical Interconnect Diagram With OPTIONAL Tablet Data Input Device Integrated Optics Heads ...

Page 22: ...ories 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 3355 XXXX Arthrex Arthroscopes Arthrex Laparoscopes Arthrex C Mount Arthroscopes AR 3200 1006 Tablet Computer Data Input Device AR 3200 1026 1027 AR 3200 1020 AR 3200 1030 1034 BioOptico Licenses DICOM Licenses Synergy net Licenses ...

Page 23: ...HD4 System Accessories Part Number Description AR 3210 XXXX AR 3200 1010 1012 AR 3200 1040 AR 3370 0006 Arthrex C mount couplers Arthrex encrypted USB sticks Arthrex Pump Shaver Kit Arthrex Starfish AR 3201 1005 Video Input Output 1080P Converter AR 3240 XXXX Arthrex Light Guides ...

Page 24: ...e from the Synergy UHD4 s Tablet Data Input Device Screens may appear slightly different than those shown in this document depending on the particular features enabled on Synergy UHD4 Figure 10 System Maintenance 2 3 1 System Set Up can be accessed by pressing the Maintenance Icon on the Synergy UHD4 Tablet Data Input Device and then selecting Advanced Settings ...

Page 25: ...em enables several facility preferences to be setup User can input the facility name associated with that specific Synergy UHD4 User can select the language used with Synergy UHD4 User can select number of cases saved to system before data is automatically purged Other configuration options are also available to users ...

Page 26: ... Synergy UHD4 System 26 of 74 Figure 12 Date Time Screen 2 3 3 Selecting Date Time enables adjustment of the Synergy UHD4 date and time settings User can use a network time server or user can select the date and time options manually ...

Page 27: ...x Synergy UHD4 System 27 of 74 Figure 13 Print Settings Screen 2 3 4 Selecting Print Settings enables adjustment of the Synergy UHD4 print settings User can enable the use of a local printer and select the paper size for that printer ...

Page 28: ...electing Network allows for connecting the Synergy UHD4 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 ...

Page 29: ...ance icon on the Synergy UHD4 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...

Page 30: ... 74 Figure 9 Surgeon 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 Synergy UHD4 ...

Page 31: ...can be added to individual 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 ...

Page 32: ...ynergy UHD4 System 32 of 74 Figure 11 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 ...

Page 33: ...950 0073 00 B SM English Arthrex Synergy UHD4 System 33 of 74 2 4 Scheduling and Starting Cases Figure 20 Scheduling a Case 2 4 1 To schedule a case press the Add New Case icon ...

Page 34: ...ct the Room if present 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 4 3 Input any of the other optional data elements in the appropriate fields 2 4 4 Press the Save icon ...

Page 35: ...System 35 of 74 Figure 13 Starting a Case 2 4 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 ...

Page 36: ... SM English Arthrex Synergy UHD4 System 36 of 74 Figure 14 Confirming a Case 2 4 6 A Case Confirmation window will appear showing the patient and case demographics If the information is correct press the Start icon ...

Page 37: ... UHD4 System 37 of 74 Figure 15 Camera Head Button Change During Case 2 4 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 ...

Page 38: ...950 0073 00 B SM English Arthrex Synergy UHD4 System 38 of 74 Figure 16 Print Changes During Case ...

Page 39: ...f 74 Figure 17 Ending a Case 2 4 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 Synergy UHD4 Tablet Data Input Device will transition to the case review screen ...

Page 40: ...REASE Brightness After a LONG press on the LEFT BUTTON pressing the Left Button will DECREASE Brightness 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 Synergy UHD4 Initial Screen will also indicate that the Printer...

Page 41: ... BALANCE below will be shown on screen Figure 20 White Balance Fail 13 If the White Balance Operation has been 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 th...

Page 42: ...950 0073 00 B SM English Arthrex Synergy UHD4 System 42 of 74 3 0 Theory of Operation Figure 30 Typical Synergy UHD4 System and Peripherals ...

Page 43: ...lowing design features are incorporated to achieve these goals Camera heads with three chip image sensors and prism as well as camera heads with a single chip image sensor Powerful digital signal processing to enhance image quality No unit to unit adjustments or calibrations Interchangeable camera heads without adjustment Digital differential signaling to and from camera head Electrical isolation ...

Page 44: ...g fan for the LED Illuminator An additional fan is provided to exhaust heat from the chassis directly The LED Illuminator is defaulted to Standby when AC power is first applied to the CCU The Motherboard and Isolation Board handles all image processing and control functions as described below Overall CCU Circuitry Figure 2131 depicts the camera circuitry Motherboard and Isolation Board with those ...

Page 45: ...950 0073 00 B SM English Arthrex Synergy UHD4 System 45 of 74 Figure 211 CCU Circuitry Block Diagram ...

Page 46: ...a hub of connectivity and control for the entire system Power The single 12V power supplied to the motherboard is switched on and off in response to the front panel push button It is then regulated and distributed further Video Signal Input The video signal from the camera head is relayed to the motherboard through the isolation board For the 4K UHD4 camera head three signals are received Each of ...

Page 47: ...d is a hand held device intended for use within the sterile field and contact with a patient It connects to the front panel of a CCU through a cable The grasping mechanism then couples to an endoscope and light guide for imaging Figure 32 UHD Head Block Diagram Figure 33 HD Head Block Diagram ...

Page 48: ...d Return Data The three channels red green and blue of the UHD 4K camera head and one channel of combined RGB video from the HD camera head are transmitted along with the status and control data to the CCU Buttons The camera head FPGA detects the movement of two Hall effect buttons through the use of an ADC converter This position information is continuously sent down on the SDI cable along with t...

Page 49: ...board during manufacturing allows for programming of the motherboard s FPGA Head FPGA The camera heads are plugged into an isolation board which has a special JTAG cable connected to the programmer The JTAG lines are routed directly within the camera head cable to the camera head s FPGA Software The CCU software controlling the operation of the embedded processor can be provided by the SD Card ins...

Page 50: ...nce The product should be inspected prior to and after each use to ensure that the camera head cable strain relief overmold or connector contacts are not damaged or worn If it becomes necessary to return the camera head to Arthrex for service please sterilize the camera head before shipping 4 3 Cleaning and Sterilizing Follow universal precautions for protective apparel when handling and cleaning ...

Page 51: ... touch 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 ...

Page 52: ...nce of detergent is 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 ...

Page 53: ...en Cycles STERRAD Systems AR 3210 XXXX Camera Heads are validated for Sterilization Assurance using the STERRAD Systems listed below and following the manufacturer s instructions for use STERRAD System 100S Short Cycle STERRAD System NX Short Cycle STERRAD System 100NX Standard Cycle 4 3 5 Material Compatibilities In addition to the Sterilization chemicals listed above the AR 3210 XXXX camera head...

Page 54: ...x video and power cables 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 light ...

Page 55: ...ace as necessary Replace the camera head with a working unit and verify image on 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 console 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 reprodu...

Page 56: ...500 V no breakdown See IEC 60601 1 for test methods 4 6 Replacement of the Lithium Battery The Camera Control Unit CCU main circuit board contains a Lithium Battery for use in the Real Time Clock Circuit This battery should have a service life of 8 years 1 If you need to replace the Lithium Battery a Use any UL recognized CR2032 Lithium Coin Cell Eveready CR2032 for example b Remove the old Lithiu...

Page 57: ...he CCU has no blemishes scratches dents marks etc that would impact device performance 1 3 Verify that there are five screws present in the back of the CCU which attach the top cover onto the CCU 1 4 Verify that a blue Operating Instructions label is installed on the top cover in the bottom left corner 1 5 Verify the LED and WHITE BALANCE buttons can be pressed and will return to their original st...

Page 58: ...ber Cables Verify a live image is present without distortion on the 4K monitor Remove fiber cables from the SFP Transceivers 4 Test Case Check 4 1 Create a test case on the CCU using the Tablet Computer Data Input Device 4 2 White balance by focusing the camera head on a white object and pressing one of the camera head buttons ensuring that White Balance OK displays on the monitor 4 3 Capture at l...

Page 59: ...essfully pairs with the CCU each time Select the Export button on the Tablet Computer Input Device If a USB stick is connected to the device select the USB icon and verify the LED above USB stick begins to blink 4 10 Delete Test Case Log into the Tablet Computer Data Input Device Select the Folder Icon as shown below Select the test case s Select Delete Select Yes to confirm Ensure the case no lon...

Page 60: ...ut Device by selecting the gear wheel at the top left of the tablet screen and selecting Log Out 4 12 Turn off the LED light engine by pressing the LED button on the front panel of the CCU 4 13 Shut down the CCU by pressing the power button on the CCU front panel 4 14 Disconnect all the cables from the CCU ...

Page 61: ...ic Certification UL 60601 1 2003 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 ...

Page 62: ...sthetics According to the mode of operation Continuous Specifications Parameter Parameter Value Power Requirements Rated Voltage 100 240 V Supply Frequency 50 60 Hz Power Input 160 VA Fuses No user serviceable fuses Video Outputs Video Output Description Display Port 2x 3480 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...

Page 63: ...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 3 cm H Camera Head Weight AR 3210 0018 Approximately 19 6 ounces 0 5 kg AR 3210 0021 Approximately 17 1 ounces 0 5 kg AR 3210 0022 Approximately 17 9 ounces 0 5 kg AR 3210 0023 Approximately 20 4 ounces 0 58 kg AR 3210 0025 Approximately 17 1 ounces 0 5 kg AR 3210 0026 App...

Page 64: ...950 0073 00 B SM English Arthrex Synergy UHD4 System 64 of 74 ...

Page 65: ...e LED Light Source Specifications Light output Minimum 1600 Lumens Typical 1800 Lumens Color Temp 70 CRI Typical 65 Minimum 5500 8500K 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 ...

Page 66: ... may cause undesired 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 ...

Page 67: ... Instruction Manual 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 Ele...

Page 68: ...ishments and those 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 m...

Page 69: ...ge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 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 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds ...

Page 70: ...rs m Field strengths 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...

Page 71: ...s equipment Rated maximum 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 5 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 meter...

Page 72: ...f 74 9 0 APPENDIX 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 33 Logging on to Android Figure 34 About Screen Figure 35 SW Version Screen ...

Page 73: ...950 0073 00 B SM English Arthrex Synergy UHD4 System 73 of 74 PAGE INTENTIONALLY LEFT BLANK ...

Page 74: ...rthrex Synergy UHD4 System 74 of 74 Arthrex Inc 1370 Creekside Blvd Naples FL 34108 USA Customer Service 866 267 9138 Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany 49 89 909005 0 All rights reserved Printed in USA ...

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