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AR-3210-0026 Arthrex, Inc. 1370 Creekside Blvd. AR-3210-0028 Naples, FL 34108, USA +1 (800) 934-4404 AR-3210-0029 Technical Support 1-888-420-9393 AR-3210-0030 Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany +49 89 909005-0 1 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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This is not a 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.
Life Expectancy..........................50 Periodic Maintenance ......................... 50 Cleaning and Sterilizing ....................... 50 Troubleshooting .......................... 54 Recommended Annual Camera Control Unit Maintenance Requirements ....... 56 Replacement of the Lithium Battery ................... 56 3 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Troubleshooting (Tests) 57 Procedure ............................ 57 Technical Information APPENDIX [Radio Module Information] 66 APPENDIX [Detailed EMC Information] 67 APPENDIX [SW Version access] 72 4 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
Matrix PWA for transmission associated accessories. Failure to of UHD4 data by fiber optic. follow these instructions can lead to: Life-threatening injuries to the patient Intended Use 5 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Do not use plug adapters or extension cords; such devices defeat the safety ground and could cause injury. 6 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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This equipment/system may cause radio or if the endoscope’s distal end is interference disrupt placed in close proximity with the tissue) operation of nearby equipment. It may 7 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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4. This device should only be used in Endoscope, the Laser should be compliance with its intended use. activated only after the tip of the laser can be seen thought the endoscope. 8 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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(water, chemical disinfectants or measures: sterilants, etc.). Notify your Arthrex Sales (a) Reorient or relocate the receiving Representative. If it is necessary to return device. the camera head to Arthrex for service, 9 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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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. 10 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
Dangerous Voltages Limits for are Present. Never Storage and attempt to repair the Transport equipment. Only Trained Service Personnel may remove the cover, or obtain access to system components. 11 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Electronics and ionizing Electrical Electromagnetic Equipment] Symbol. Radiation Regarding European Union End-of-Life of Product. White Balance Color Video Symbol Camera LED Light Do Not Use if Damaged Made for iPad 12 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
In the US a list of recyclers in your area can be 8. Whoever connects additional equipment found at www.eiae.org/ to signal input or signal output is obligated to meet the requirements of the EN 60601-1-1 standard. 13 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
Unpacking and Inspecting the transport packaging. Please make sure that all Device required information has been supplied. Call Arthrex for a RMA Number for the device return UHD4 for service. Upon receipt, carefully unpack the Synergy ...
LED Light Source between ON [Operational INDICATOR then Insert Mode] and STANDBY. Light Guide. PRECAUTION: Use only FUSED Light Guides to ensure proper operation of LED Engine. 15 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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9. Tablet Connection-Connection for Tablet Accepts the supplied hospital grade power Data Input device. Provides data cord. interchange and tablet charging 16 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Figure 3 - AR-3210-0023 4K SynergyUHD4 Camera Head, autoclavable Figure 4 - AR-3210-0029 HD, SynergyUHD4 Broadband Camera Head, autoclavable 17 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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2. Button 2 A programmable button that locks into place the compatible scope. can activate various functions of the DIN 58105 compliant endoscope camera. See “Optional Tablet Data Input interface. Device” for programming information. 18 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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See “Optional Tablet Data Input camera. See “Optional Tablet Data Input Device” for programming information. Device” for programming information. 16. C-Mount Threads Accepts standard C- Mount Optical Couplers. 19 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
On/Standby Switch will not of the Display Port cable to the Display Port activate the LED light engine until one is input of the display monitor. (3G-SDI or DVI connected. 20 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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UHD4 Figure 8 - Synergy Typical Interconnect Diagram With OPTIONAL Tablet Data Input Device [Integrated Optics Heads] 21 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
Figure 10 - System Maintenance 2.3.1 System Set-Up can be accessed by pressing the Maintenance Icon on the UHD4 Tablet Data Input Device and then selecting “Advanced Settings”. Synergy 24 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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User can select the language used with Synergy User can select number of cases saved to system before data is automatically purged. Other configuration options are also available to users. 25 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Selecting “Date & Time” enables adjustment of the Synergy 2.3.3 date and time settings. User can use a network time server or user can select the date and time options manually. 26 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Selecting “Print Settings” enables adjustment of the Synergy 2.3.4 print settings. User can enable the use of a local printer and select the paper size for that printer. 27 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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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. 28 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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“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 8 - Surgeon Management Preferences 29 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Surgeon preferences can be defined for the following: Camera Button Settings Printer Settings Print Settings Multimedia Web Server Access Display UHD4 BioOptico (Note: BioOptico is optional functionality for Synergy 30 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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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. 31 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Figure 11 - Surgeon Procedure Settings Once a Procedure has been added select the “Procedure Settings” next to the Procedure 2.3.12 name to configure camera, pump, and shaver settings associated with the Procedure. 32 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
Scheduling and Starting Cases Figure 20 - Scheduling a Case To schedule a case, press the “+ Add New Case” icon 2.4.1 33 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Patient First Name Patient Last Name Patient I.D. # 2.4.3 Input any of the other optional data elements in the appropriate fields. Press the “Save” icon. 2.4.4 34 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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To start a case, select the case/patient from the Case List and press the “Start” icon. 2.4.5 NOTE: Cases may also be started from the “Add Case” screen by entering the required fields and pressing the “Start” icon. 35 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Figure 14 - Confirming a Case A “Case Confirmation” window will appear showing the patient and case demographics. If the 2.4.6 information is correct press the “Start” icon. 36 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Changes to SETTINGS may be made during the procedure by pressing the “Maintenance 2.4.7 Icon”. Changes may be made to the following: Camera Head Button Functions Print Settings 37 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Figure 16 - Print Changes; During Case 38 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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NOTE: An “End the Case?” confirmation message will appear. If confirmed, the case will end UHD4 and the Synergy Tablet Data Input Device will transition to the case review screen. 39 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
10. Using a stack of 4 x 4 white gauze, hold the tip of the Endoscope approximately 1 inch away from the gauze until the gauze image fills the screen completely. 11. Press either of the Camera Head buttons to start the White Balance Operation. 40 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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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 UHD4 will function as defined on the Synergy Initial Screen Figure . 41 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
DVI or 3G-SDI connections at 1080p format Medical grade printers utilizing USB connections USB memory and mass storage devices Arthrex Tablet Computer Data Input Device as a user interface connected to a dedicated USB port Ethernet communication and networking ...
A membrane panel on the front of the CCU provides for control buttons and LED indicators. These are split between the essential section (for LED Illuminator control and White Balance) and the software section (for USB activity LEDs). 44 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Figure 211 - CCU Circuitry Block Diagram 45 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
Video output over 10GbE fiber cable, directly to a compatible monitor or through a 10G UHD4 fiber switch, is provided with the AR-3200-0020 Synergy CCU with Matrix model. Two 10GbE fiber cables and SFP+ modules are required to send 4K images.
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 47 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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The camera head cable assembly’s proximal end contains circuitry for receiving and repeating the high speed video signals. This repeater re-drives the signal over the card edge to the isolation board. 48 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
The CCU software, controlling the operation of the embedded processor can be provided by the SD Card inserted into the motherboard or by pre-programming the NOR Flash. Application programs and data are stored on the installed Solid State Drive. 49 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
If it becomes necessary to return the camera head to Arthrex for service, please sterilize the camera head before shipping.
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Return camera heads with damaged cables to Arthrex for repair. 9. Before sterilization and/or disinfection, coil the camera head cable into loops at least six inches in diameter. Do not kink or twist the cable. 51 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Pre-vacuum 132° C (270° F) 4 Minutes 30 Minutes Steam (Wrapped) Gravity 132° C (270° F) 15 Minutes 30 Minutes Steam (Un-Wrapped) Gravity 132° C (270° F) 10 Minutes 52 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Sterilization section may result in the compromise of the device’s safety and effectiveness. Use of Sterilants or Chemicals other than those listed in the “Cleaning and Sterilization” section shall void the product’s warranty. 53 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
Reprogram camera head buttons. Camera head buttons Incorrect camera head button NOTE: Tablet Data Input device option do not function as only. programming. programmed. 54 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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System does not boot up Power down device, wait 3 correction./Banners do not Improper shut down of CCU. display or do not display minutes, and restart system. properly. 55 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
It will not allow for incorrect insertion of the Battery into the holder. (d) Recycle the used battery. Warning; Replacement of battery by inadequately trained personnel could result in a Hazard such as Excessive Temperatures or Fire. 56 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
Insert the endoscope into the camera head. Power up the unit by inserting the power cord into the power receptacle in back of the CCU. 57 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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If using an iPad, select the “Export” button on the Tablet Computer Input Device and select the iPad icon. Verify that theexport progress bar completes on the Tablet. Launch the Arthrex Synergy Surgeon application on the iPad and confirm that the case successfully uploaded to the application. 58 of 74...
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Select the Folder Icon as shown below: Select the test case(s). Select Delete. Select “Yes” to confirm. Ensure the case no longer appears in the Archived Cases list. 59 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Turn off the LED light engine by pressing the “LED” button on the front panel of 4.12 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. 60 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
EMC Certifications EMC Certification Certification to EN 60601-1-2 Class A Safety Certification Marking CE Marking for MDD 93/42/EEC, RoHS 2011/65/EU, and R&TTE CE Marking 1999/5/EC 61 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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:C-Mount Head 17” [W] x 3.5” [H] x 13.5” [D] Approximately: CCU Dimensions 43.2 cm [W] x 8.9 cm [H] x 34.3 cm [D] CCU Weight Approximately: 15 pounds/6.8 kg 62 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Atmospheric Pressure: 500 hPa to 1060 hPa Ambient Temperature: +50°F to 73°F [10°C to 23°C] Operating Conditions Relative Humidity: 30% to 75%, non-condensing Altitudes ≤ 3000 m Atmospheric Pressure: 63 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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5500-8500K Specifications LED Life > 30,000 hours ACMI™ Standard, Storz™, Wolf™ and Light Guide Port Olympus™ Turret DICOM Specifications DICOM Statement DICOM Compatible with installation of AR-3200-1020 DICOM Key 65 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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(2) this device must accept any interference received, including interference that 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;...
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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 67 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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Display Port Output to 2.0 M Video Monitor DVI Video Out to 3.0 M Monitor 3 pin mini Stereo Accessory Port 1.8 M Ethernet CCU to Computer CCU to Printer 1.8 M 68 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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IEC 61000-4-8 NOTE: U is the a.c. mains voltage prior to application of the test level. 69 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be UHD4 considered. If the measured field strength in the location in which the Arthrex Video System is used exceeds the UHD4 applicable RF compliance level, above, the Arthrex Video System should be observed to verify normal operation.
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Video System is intended for use in an electromagnetic environment in which radiated RF disturbances are UHD4 controlled. The customer or the user of the Arthrex Video System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment [transmitters] and the...
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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 72 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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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. 74 of 74 950-0073-00 B SM, English, Arthrex Synergy UHD4 System...
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