Stryker Endoscopy XFC2 Crossfire 2 Console User Manual

Stryker Endoscopy Crossfire 2 Console

user manual

Crossfire™ 2REF 0475100000DRAFT
EN-1ContentsWarnings and Cautions .....................................................................3Product Description/Intended Use ................................................7Package Contents ................................................................................8Available Accessories ...........................................................................8The Crossre2 Console ........................................................................9The Crossre2 Interface .....................................................................11Arthroscopy Mode ............................................................................12Indications for Arthroscopic Use .........................................................12Setup and Device Connections ...........................................................13Adjusting User and System Settings ....................................................17Arthroscopic Shaver Controls ..............................................................19RF Ablation Controls ..........................................................................25Dual Controls .....................................................................................30Laparoscopy Mode ...........................................................................32Indications for Laparoscopic and General Surgery Use .........................32Setup and Device Connections ...........................................................33Adjusting User and System Settings ....................................................36Vessel Sealing Controls .......................................................................38Troubleshooting................................................................................44Error Codes ........................................................................................46Cleaning and Maintenance ............................................................47Cleaning ............................................................................................47Maintenance......................................................................................47Disposal ............................................................................................48Technical Specications ..................................................................49Generator Output ..............................................................................50Electromagnetic Compatibility ...........................................................55Symbol Glossary ................................................................................59
EN-3DRAFTWarnings and CautionsPlease read this manual and follow its instructions carefully. The words warning, caution, and note carry special meanings and should be carefully reviewed:Warning Warnings indicate risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user. Caution Cautions indicate risks to the equipment. Failure to follow cautions may result in product damage. Note Notes provide special information to clarify instructions or present additional useful information. To avoid potential serious injury to the user and the patient and/or damage to this device, the user must obey the following warnings. The warranty is void if any of these warnings is disregarded.1. Caution: Federal law (USA) restricts this device to use by, or on order of, a physician.2. Attempt no internal repairs or adjustments not specically detailed in this operating manual. Refer any readjustments, modications, and/or repairs to Stryker Endoscopy or its authorized representatives.3. Pay close attention to the care and cleaning instructions in this manual. Failure to follow these instructions may result in product damage.4. Install this device in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices.5. DO NOT use the Crossre2 system on patients with cardiac pacemakers or other electronic device implants. Doing so could lead to electromagnetic interference and possible death.Fire/Explosion Warnings1. DO NOT use this device in the presence of ammable anaesthetics, other ammable gases or objects, near ammable uids such as skin prepping agents and tinctures, or oxidizing agents. Observe appropriate re precautions at all times.2. DO NOT use this device in oxygen-enriched atmospheres, nitrous oxide (N₂O) atmospheres, or in the presence of other oxidizing agents, to prevent risk of explosion. Ensure that oxygen connections are not leaking.
EN-4DRAFT3. Electrosurgical components, such as the probe, may remain hot following activation. Keep all electrosurgical equipment away from ammable materials to avoid combustion.4. To prevent the risk of re, DO NOT replace console fuses. If it is suspected that fuses are damaged, return console to Stryker for repair.Prior to Surgery1. The operator of the Crossre2 system should be a qualied physician, having complete knowledge of the use of this equipment and awareness of the risks associated with arthroscopic and laparoscopic electrosurgical procedures.2. The operator of the Crossre2 system should be experienced in arthroscopic and electrosurgical practices and techniques.3. The operator of the Crossre2 system should read this manual thoroughly and be familiar with its contents prior to operating the equipment.4. The operator of the Crossre2 system should be sure that the system functions as outlined in this manual prior to a surgical procedure. The Crossre2 system was fully tested at the factory before shipment. 5. Crossre2 system components are designed to be used together as a system. Use only the appropriate footswitch, handpiece, and disposable attachments described in this manual.6. Carefully unpack the unit and ensure that all components are accounted for and remain undamaged from shipment. Inspect the handpiece cable for any damage to insulation. If damage to any component is detected, refer to the “Service and Claims” section of this manual.7. Ensure the proper connection of the primary power cord of the Crossre2 System to a grounded receptacle. To prevent risk of electric shock DO NOT use extension cords or adapter plugs.8. DO NOT wrap the handpiece cable around metal objects, or the induction of hazardous currents may result.9. Position the cables to avoid contact with the patient, electrodes, cables, and any other electrical leads which provide paths for high frequency current.10. Position the console so the fan directs the ow of air away from the patient.11. When the Crossre2 system and physiological monitoring equipment are used simultaneously on a patient, position any monitoring electrodes as far as possible from the surgical electrodes. Monitoring equipment using high frequency, current-limiting devices is recommended. Needle
EN-5DRAFTmonitoring electrodes are NOT recommended.12. Smoke generated during electrosurgical procedures may be harmful to surgical personnel. Take appropriate precautions by wearing surgical masks or other means of protection.During Surgery1. DO NOT use the Crossre2 system with non-conductive irrigants (e.g. sterile water, air, gas, glycine, etc.). Use only conductive irrigants such as saline or Ringer’s lactate in order for the system to function properly.2. DO NOT allow the patient to come into contact with grounded metal objects or objects that have an appreciable capacitance to the earth, such as a surgical table frame or instrument table, to prevent risk of shock. The use of antistatic sheeting is recommended for this purpose.3. DO NOT activate the Crossre2 system for prolonged lengths of time when the attachment is not in contact with tissue. Doing so may lead to unintentional damage to surrounding tissue.4. When the Crossre2 system is activated, the conducted and radiated electrical elds may interfere with other electrical medical equipment. Provide as much possible distance between the console and other electronic medical equipment.5. Select the lowest output power required to prevent patient injury.6. Maintain the active electrode in the eld of view at all times to avoid tissue damage.7. Remove the handpiece and disposable attachments from the surgical site and place them away from metallic objects when not in use. Attachments should be separated from other electrosurgical equipment to avoid inadvertent electrical coupling between devices. Inadvertent activation may cause user/patient injury and/or product damage.8. Keep the ends of the handpiece cable connectors, footswitch cable connectors, and console receptacles away from all uids.9. DO NOT activate the Crossre2 system until the probe is properly positioned in the patient.10. Ensure that the probe tip, including the return electrode, is completely surrounded by irrigant solution during use.11. Keep the activation indication lights and speaker in eld of view and hearing at all times during activation. The light and sound are important safety features.12. DO NOT touch the attachment to metal objects, such as an endoscope or metal cannula, while activating the handpiece. Damage to the attachments or other devices may result.
EN-6DRAFT13. DO NOT obstruct the fan (located near the rear of the console).14. Failure of the system may result in an unintended increase in output power.15. During use, operators should wear standard surgical gloves to help reduce the risk of electric shock.After Surgery1. DO NOT attempt to reuse or resterilize any product labeled “Single-Use,” as this may lead to equipment malfunction, patient/user injury, and/or cross contamination.2. DO NOT use ammable agents for cleaning and disinfection of the Crossre2 console, handpiece, or footswitch.3. DO NOT remove the cover of the console as this could cause electric shock and product damage.4. Attempt no internal repairs or adjustments, unless specied otherwise in this manual. Units requiring repair should be returned to Stryker.5. Disconnect the Crossre2 system from the electrical output when inspecting fuses.
EN-7DRAFTProduct Description/Intended UseThe Crossre2 Integrated Resection and Sealing System is a combination powered shaver system/electrosurgical generator that powers arthroscopic shaver handpieces, RF surgical probes, and vessel-sealing handpieces for use in a variety of arthroscopic, orthopedic, and general laparoscopic surgeries.Illustrated below, the Crossre2 system consists of the following components:213541. Crossre2 Console (featured in this manual)• Acts as a connection hub for the various components of the Crossre2 system• Powers a motorized shaver handpiece for the mechanical cutting and debridement of bone and soft tissue• Generates bipolar radio frequency (RF) energy for vessel sealing and the electrosurgical cutting and coagulation of tissue• Provides a central user interface for operating the Crossre2 system2. Disposable RF probe Enables RF cutting and coagulation3. Powered shaver handpiece (and disposable attachments)Enables arthroscopic cutting and debridement4. Crosseal Handpiece Enables vessel sealing5. Crossre Footswitch Provides remote, foot control of the powered shaver handpiece and RF probe
EN-8DRAFTPackage ContentsCarefully unpack the Crossre2 console and inspect each of the following components. Report any damaged components to Stryker. (1) Crossre2 console (1) Hospital-grade power cord(1) User guideAvailable AccessoriesThe Crossre2 system is compatible with the following accessories:System Accessories0475-000-100 Crossre Footswitch0277-200-100 iSWITCH Universal Wireless Footswitch Receiver0277-200-101 iSWITCH Universal Wireless Footswitch Receiver (AUS)0277-100-100 iSWITCH Universal Wireless Footswitch6000-001-020 Stryker rewire cableArthroscopy Accessories0279-xxx-xxx SERFAS Energy family of electrosurgical probes 0375-708-500 Formula 180 Handpiece0375-704-500 Formula Handpiece (with buttons)0375-701-500 Formula Handpiece (without buttons)0275-601-500 Small-Joint Shaver HandpieceLaparoscopy Accessories0250-080-800 35 cm Crosseal Vessel Sealing Handpiece0250-080-850 45 cm Crosseal Vessel Sealing Handpiece
EN-9DRAFTThe Crossre2 ConsoleThe Crossre2 console is the connection hub for the components of the Crossre2 system. It generates RF energy for ablation and vessel sealing, powers motorized shavers, and provides user controls and system feedback. Front PanelThe front console panel features ports for connecting handpieces, controls for adjusting handpiece settings, and an LCD screen to provide system feedback.CROSSFIRE IIINTEGRATED RESECTION AND SEALING SYSTEM1 25 6 7 8 93 41. Menu Selects menu items2. Select Selects which device displays on the LCD screen.3. RF connector (SERFAS Energy and Crosseal Handpieces)Delivers RF energy for ablation or vessel sealing handpieces4. Handpiece connector Powered shaver handpiece5. Power Powers the console on and o6. Error indicator Shines red to indicate errors (error details appear in the LCD)7. LCD screen Provides system feedback8. Adjust Adjusts options for connected devices9. Footswitch connector Crossre Footswitch
EN-10DRAFTRear PanelThe rear panel provides ports for connecting the console to other Stryker equipment. 1 2 3 41. Firewire Connectors Enables connection to other Stryker Firewire devices, such as the iSWITCH Universal Wireless Footswitch2. USB Drive Enables software installation from authorized service personnel3. Equipotential Ground Plug—4. AC Power Inlet —
EN-11DRAFTThe Crossre2 InterfaceThe Crossre2 interface displays system status, enables you to choose between RF ablation, RF vessel sealing, and shaver modes, and enables you to adjust power and speed settings. Activating the actual handpieces is performed through controls on the handpiece and on the Crossre Footswitch. 1 4 52 3Control Description1. Menu The Menu button opens a menu for selecting user and system settings. 2. Error indicatorThe Error indicator shines red when a system error occurs.3. LCD screen The LCD screen displays system status, error codes, mode of operation, cutting speed, and power levels. 4. Select The Select button toggles between RF and Shaver controls. The selected device can then be controlled using the Crossre2 interface. 5. Adjust The Adjust buttons increase/decrease speed and power settings for the selected device.
EN-12DRAFTArthroscopy ModeIndications for Arthroscopic UseThe Stryker Crossre 2 system is indicated for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The crossre system provides abrasion, resection, debridement and removal of bone and soft tissue through its shaver blade; and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the prodict include resection of torn knee cartilage, subcromial decompression, and resection of synovial tissue in other joints.ContraindicationsThe electrosurgical probe should not be used in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.
EN-13DRAFTSetup and Device ConnectionsStryker Endoscopy considers instructional training an integral part of the Crossre2 system. Your Stryker Endoscopy sales representative will perform at least one inservice at your convenience to help you set up your equipment and instruct you and your sta on its operation and maintenance. Please contact your local Stryker Endoscopy representative to schedule an in-service after your equipment has arrived.Warning Be sure that no liquid is present between connections to the console and the handpiece. Connection of wet accessories may lead to electric shock or electrical short.To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.Use only hospital-grade power cables. Using other cables may result in increased RF emissions or decreased immunity from such emissions.Only the handpieces and disposable attachments are suitable for use in the patient environment. The console and footswitch are not sterile devices and should not enter the sterile eld. The Crossre2 System is compatible only with the Stryker handpieces and footswitches listed in this manual. Do not connect any equipment not specied in this manual, as unexpected results or serious injury will occur.
EN-14DRAFT1. Place the console on a sturdy platform, such as a Stryker cart.• Select a location according to the recommendations in the preceding EMC tables.• Leave four inches of space around all sides for convection cooling.2. Connect the AC power.CROSSFIRE IIINTEGRATED RESECTION AND SEALING SYSTEM3. Connect the handpieces and footswitch. (Note: Vessel sealing handpieces are not intended to be connected during arthroscopic procedures.) The console will display an error message if expired or used attachments are connected: 4. Connect suction tubing (for all suction-capable devices).
EN-15DRAFTUsing the iSWITCH Wireless FootswitchThe Crossre2 system can be used with the iSWITCH Wireless Footswitch System. 1. Connect the Crossre2 console to the iSWITCH console using one of the Firewire connection ports on each console. 2. Consult the iSWITCH Operating and Maintenance Manual (P/N1000-400-700) for further operation instructions.
EN-16DRAFTPowering the Console On and OPress the power button to power the console on and o. The button will shine green when the console is on. Warning Should emergency shutdown become necessary, power o the console as described above. As an added safety measure, the console can be separated from the AC power mains by detaching the AC power cord from either end.
EN-17DRAFTAdjusting User and System SettingsUser Preference SettingsUser preferences, such as power and cutting speeds and button assignments for the handpiece and footswitch, can be adjusted through the Crossre2 interface.Select from the default settings provided with the console, or contact your Stryker representative to customize your own.1. Press . DEFAULT SMITH SHLDRSMITH KNEE2. Press to select a default setting.3. Press to conrm selection and exit. Or, press to cancel selection. Note: User preference settings will not take eect unless a disposable attachment is connected to the shaver.
EN-18DRAFTSystem SettingsSystem settings, such as screen brightness, contrast, and system sound can be adjusted through the Crossre2 interface.1. Press and hold . (Note: If an RF probe is connected to the console, the COAG adjustment screen will appear. Press again to access the system settings screen.)2. Press to choose (contrast), (brightness), or (sound). (The will indicate your selection.)3. Press to adjust.4. Press and hold to exit. (Note: A short press will display the current version of the console software.)
EN-19DRAFTArthroscopic Shaver ControlsWarning The Crossre2 system is intended for use only by licensed medical professionals, properly trained in the use of electrosurgical equipment and techniques. The Crossre2 system generates potentially hazardous levels of energy that can result in injury or even death if improperly used. Before using the Crossre2 system in an actual procedure, verify that each component is installed and functioning properly. Improper connection may cause arcing or malfunction of the handpiece or console, which can result in injury, unintended surgical eect, or product damage.During use, operators should wear standard surgical gloves to help reduce the risk of electric shock.Warning During use, the RF, Crosseal, and shaver handpieces generate electronic noise that may interfere with EKG readings. Before responding to any erratic EKG readings, rst power down the system to ensure the readings are not the result of system noise. Shaver handpieces are provided nonsterile and must be cleaned and sterilized prior to each use, according to the reprocessing instructions provided in the handpiece manual.
EN-20DRAFTDefault Handpiece Controls123Default 1 Default 2 / NoneDefault 31. Oscillate (one touch)1TOUCHActivate / DeactivateOscillate (one touch)1TOUCH2. Forward (one touch)1TOUCHSelect Mode:Oscillate or Forward /ReverseJog3. Reverse (one touch)1TOUCHForward/ReverseForward (one touch)1TOUCHNote: Default settings can be selected in the User Preference Settings screen on the console. Settings will not take eect until a disposable attachment is connected to the shaver handpiece.
EN-21DRAFTDefault Footswitch ControlsThe RF and shaver handpieces can also be controlled by the Crossre Footswitch. The default footswitch controls for the shaver handpiece are shown below. To customize button assignments, contact your Stryker representative.Button FunctionDefault 1 Default 2 / None Default 3I Jog Select Mode:Oscillate or Forward/ReverseSelect Mode:Oscillate or Forward/ReverseII Select Handpiece:RF or ShaverSelect Handpiece:RF or ShaverSelect Handpiece:RF or ShaverIII Select Direction:Forward or ReverseSelect Speed:High or LowSelect Speed:High or LowA Oscillate (xed)FIXEDOscillate/Reverse (variable)VAROscillate/Reverse (xed)FIXEDB Forward/Reverse (variable)VAROscillate/Forward (variable)VAROscillate/Forward (xed)FIXED
EN-22DRAFTNote: When using small-joint handpieces, only Default 2 settings are available. No other defaults or user preferences can be applied. Adjusting Cutting SpeedUse the buttons on the console to manually adjust the power or speed setting for the active handpiece. Note: In shaver mode, the console uses radio frequency identication (rfid) to automatically detect which type of disposable attachment is connected to the handpiece. Upon recognition, the console adjusts to an optimal preset cutting speed, direction, and power. Note: Forward and reverse settings are adjusted independent of each other. Adjusting settings in one mode will not aect the other.
EN-23DRAFTReading the LCDIn shaver mode, the LCD will show:VARF9000MC DISP NAME1 23 541. Footswitch statusCrossre Footswitch connectediSWITCH footswitch connectednot connected2. Footswitch response1TOUCH one touch(pressing the foot pedal once will activate the shaver to a default speed; pressing again will stop it)FIXED xed(pressing the foot pedal at any pressure will result in a constant speed)VAR variable(shaver speed will vary, depending on the pressure applied to the foot pedal)mix(oscillate speed is xed; forward/reverse speed is variable)3. Direction FforwardRreverseoscillate4. Cutter name (name)5. Speed (#) rotations per minute
EN-24DRAFTSystem FeedbackEvent Audible Feedback Visible Feedback (via LCD)Reverse activated ve high beepsRForward activated/resumedlow beepFAdjustments made to speed settingsone beep for each unit of changeSpeed indicator number increases or decreases
EN-25DRAFTRF Ablation ControlsWarning During use, the RF, Crosseal, and shaver handpieces generate electronic noise that may interfere with EKG readings. Before responding to any erratic EKG readings, rst power down the system to ensure the readings are not the result of system noise. RF and Crosseal handpieces are intended for single use only and should not be reprocessed or reused.Default handpiece controls1231. Adjust CUT power level (single press) or Activate/deactivate Force Modulation (press and hold for three seconds)2. Activate CUT3. Activate COAG
EN-26DRAFTDefault footswitch controlsThe RF and shaver handpieces can also be controlled by the Crossre Footswitch. The default footswitch controls for the RF probe are shown below. To customize button assignments, contact your Stryker representative.Button Function (controls are the same for defaults 1, 2, and 3)I Decrease Cut LevelII Select Handpiece:RF or ShaverIII Increase Cut LevelA CutB Coag
EN-27DRAFTAdjusting CUT powerTo adjust CUT power:• Press the buttons on the console • Press the gray button on the handpiece (increase)• Press the I (decrease) and III (increase) buttons on the footswitchAdjusting COAG powerTo adjust COAG power: 1. Press and hold . The COAG POWER LEVEL screen will appear. COAG1 COAG2 COAG3COAG POWER LEVEL2. Press to adjust.3. Press to confirm selection and exit. Note: COAG power can only be adjusted when an RF probe is connected to the console.Selecting Force ModulationThe Crossre2 Console features an additional RF mode known as Force Modulation. Force Modulation is an alternative ablation mode that duty cycles RF output at a low frequency to achieve a lower average power output than in normal CUT mode. Currently, Force Modulation is an option only with the following SERFAS Energy probes: 90-S, 90-S Max, and Super 90-S. • To activate Force Modulation, hold down the grey power button on the SERFAS probe for three seconds. A hammer icon will appear on the LCD screen of the console, indicating Force Modulation activated.• To deactivate Force Modulation, hold down the grey power button on the SERFAS probe for three seconds. The hammer icon will disappear from the LCD screen.
EN-28DRAFTReading the LCDIn RF ablation mode, the LCD will show:1235411SERFASHC. . .671. Footswitch status Crossre Footswitch connectediSwitch footswitch connectednot connected2. Mode cut mode activatedcoagulation mode activated3. Force modulation force modulation activatedforce modulation not activated4. COAG power lowmediumhigh5. Hand controls hand control is enabledhand control is disabled6. CUT power (#) power setting7. Disposable RF probe name (name)
EN-29DRAFTSystem FeedbackEvent Audible Feedback Visible Feedback (via LCD)CUT activated high, steady toneCOAG activated low, steady toneForce modulation on / oSingle beepSystem error Ten short beepsAdjustments made to power settingsone beep for each unit of changeCUT power indicator number increases or decreasesChange footswitch to control RF mode“SERFAS” “SERFAS” appearsChange footswitch to control Shaver mode“Shaver” disposable name appears
EN-30DRAFTDual ControlsIn arthroscopic procedures, RF probes and arthroscopic shaver handpieces can be simultaneously connected to the Crossre 2 system, enabling users to toggle quickly between RF ablation and arthroscopic functions. Selecting between RF Ablation Mode and Arthroscopic Shaver Mode for Footswitch ControlSelecting a mode will enable the selected handpiece to be controlled by the footswitch. To select the appropriate mode, do one of the following:• Press on the Crossre2 interface. The interface will toggle between modes. The device controlled by the footswitch will appear on the right side of the LCD and will be identied by the icon.• Press the toggle button (II) on the footswitch.Note: Either handpiece can be activated at any time by pressing the button on the handpiece.Activating a handpieceTo activate a handpiece in dual mode, do one of the following:• Press any button on the desired handpiece.• Press the footswitch pedal for the active handpiece. (The active is identied by handpiece appears on the right side of the LCD.)
EN-31DRAFTReading the LCDIn dual mode, the LCD will show the status of both devices. Whichever device is controlled by the footswitch will appear on the right side of the LCD. F9000FIXED11SERFAS MC DISP NAMEDual mode, shaver handpiece controlled by footswitch.F9000FIXED 11SERFASMC DISP NAMEDual mode, RF probe controlled by footswitch.Adjusting handpiece settings with the consoleIn dual mode, settings can be adjusted for whichever handpiece appears on the right side of the LCD.1. Press to move the desired handpiece to the right side of the LCD.2. Use the buttons on the console to manually adjust the power or speed setting for the selected handpiece.
EN-32DRAFTLaparoscopy ModeIndications for Laparoscopic and General Surgery UseThe Stryker Crossre 2 system is indicated for use in laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to and including 7 mm and bundles as large as will t in the jaws of the instruments.Contraindications• The system should not be used with atherosclerotic vessels (calcied vessels) as vessels will not seal. • Crosseal should not be used in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.• The Crosseal system should not be used for tubal ligation.
EN-33DRAFTSetup and Device ConnectionsStryker Endoscopy considers instructional training an integral part of the Crossre2 system. Your Stryker Endoscopy sales representative will perform at least one inservice at your convenience to help you set up your equipment and instruct you and your sta on its operation and maintenance. Please contact your local Stryker Endoscopy representative to schedule an in-service after your equipment has arrived.Warning Be sure that no liquid is present between connections to the console and the handpiece. Connection of wet accessories may lead to electric shock or electrical short.To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.Use only hospital-grade power cables. Using other cables may result in increased RF emissions or decreased immunity from such emissions.Only the handpieces and disposable attachments are suitable for use in the patient environment. The console and footswitch are not sterile devices and should not enter the sterile eld. The Crossre2 System is compatible only with the Stryker handpieces and footswitches listed in this manual. Do not connect any equipment not specied in this manual, as unexpected results or serious injury will occur.
EN-34DRAFT1. Place the console on a sturdy platform, such as a Stryker cart.• Select a location according to the recommendations in the preceding EMC tables.• Leave four inches of space around all sides for convection cooling.2. Connect the AC power.CROSSFIRE IIINTEGRATED RESECTION AND SEALING SYSTEM3. Connect the handpiece and footswitch. (Note: Arthroscopic handpieces are not intended to be connected during laparoscopic procedures.)
EN-35DRAFTUsing the iSWITCH Wireless FootswitchThe Crossre2 system can be used with the iSWITCH Wireless Footswitch System. 1. Connect the Crossre2 console to the iSWITCH console using one of the Firewire connection ports on each console. 2. Consult the iSWITCH Operating and Maintenance Manual (P/N1000-400-700) for further operation instructions.Powering the Console On and OPress the power button to power the console on and o. The button will shine green when the console is on.
EN-36DRAFTWarning Should emergency shutdown become necessary, power o the console as described above. As an added safety measure, the console can be separated from the AC power mains by detaching the AC power cord from either end. Adjusting User and System SettingsUser Preference SettingsUser preferences, such as button assignments for the handpiece and footswitch, can be adjusted through the Crossre2 interface.Select from the default settings provided with the console, or contact your Stryker representative to customize your own.1. Press . DEFAULT SMITH SHLDRSMITH KNEE2. Press to select a default setting.3. Press to conrm selection and exit. Or, press to cancel selection.
EN-37DRAFTSystem SettingsSystem settings, such as screen brightness, contrast, and system sound can be adjusted through the Crossre2 interface.1. Press and hold . 2. Press to choose (contrast), (brightness), or (sound). (The will indicate your selection.)3. Press to adjust.4. Press and hold to exit. (Note: A short press will display the current version of the console software.)
EN-38DRAFTVessel Sealing ControlsWarning The Crossre2 system is intended for use only by licensed medical professionals, properly trained in the use of electrosurgical equipment and techniques. The Crossre2 system generates potentially hazardous levels of energy that can result in injury or even death if improperly used. Before using the Crossre2 system in an actual procedure, verify that each component is installed and functioning properly. Improper connection may cause arcing or malfunction of the handpiece or console, which can result in injury, unintended surgical eect, or product damage.During use, operators should wear standard surgical gloves to help reduce the risk of electric shock.Warning During use, the RF, Crosseal, and shaver handpieces generate electronic noise that may interfere with EKG readings. Before responding to any erratic EKG readings, rst power down the system to ensure the readings are not the result of system noise. RF and Crosseal handpieces are intended for single use only and should not be reprocessed or reused.
EN-39DRAFTDefault Handpiece Controls3211. grasp2. seal3. cut (mechanically)Note: For complete instructions on how to use the Crosseal handpiece, consult the Crosseal Handpiece User Guide (P17278).
EN-40DRAFTDefault footswitch controlsThe RF and shaver handpieces can also be controlled by the Crossre Footswitch. The default footswitch controls for the vessel sealing handpiece are shown below. To customize button assignments, contact your Stryker representative.Button Function (controls are the same for defaults 1, 2, and 3)I Decrease Seal LevelII Select Handpiece:RF, Crosseal, or ShaverIII Increase Seal LevelA Activate/SealB Activate/Seal
EN-41DRAFTReading the LCDIn vessel sealing mode, the LCD will show:164HC53VESSEL SEALERSEAL2 31. Progress indicator indicates progress of vessel sealing2. Footswitch status Crossre Footswitch connectediSwitch footswitch connectednot connected3. Sealing status SEAL vessel sealing in progressvessel sealing not in progress4. Seal power (#) power setting5. Hand controls hand control is connected and its buttons are active6. Handpiece indicator vessel sealing handpiece is connected
EN-42DRAFTSystem FeedbackEvent Audible Feedback Visible Feedback (via LCD)Sealing activated / in progresssteady tone SEALprogress barSealing complete two high beeps SEALprogress barSealing error alternating high/low tonesvessel-sealing error
EN-43DRAFTVessel-Sealing ErrorsDuring vessel sealing, the Crossre 2 system will indicate sealing progress. Should a seal be unsuccessful, the LCD will display an appropriate error message:12 312 31. Error Code2. Description SolutionA1 No Vessel FoundRegrasp tissue and retry sealA2 Incomplete SealA3 Incomplete Seal
EN-44DRAFTTroubleshootingProblem Possible SolutionConsole A hardware fault is detected• Turn the power o and on again.• If the problem persists, contact a Stryker representative or return the console for repair.The AC voltage is incorrect• Turn the power off and on again.• If the problem persists, contact a Stryker representative or return the console for repair.A software fault is detected• Turn the power off and on again.• If the problem persists, contact a Stryker representative or return the console for repair.The system does not power on• Check the power cord to ensure it is properly connected.• Check to ensure the cord is connected to a grounded outlet.The electrical interference is sporadic• Power down all electrical equipment not in use.• Increase distance of other electrical equipment.• Connect the unit and other equipment into dierent outlets.The generator temperature is too high• Ensure that there is proper airow around the unit.A power-on self test error has occurred• Turn the power o and on again.• If the problem persists, contact a Stryker representative or return the console for repair.
EN-45DRAFTHand-pieceThe temperature is higher than normal• Allow the unit to cool before restarting.The unit has reached its recommended service interval• Contact your Stryker representative.DisposableAttachmentsRF probe is not ready• Check the connection to the console.RF probe is expired• Replace probe.RF probe identication is invalid• Replace probe.RF probe communication error• Check the connection to the console.• If necessary, replace probe.Exceeded time usage• Replace probeRF power is too high• Check the probe for damage.• If necessary, replace probe.RF voltage is too high• Check the probe for damage.• If necessary, replace probe.RF current is too high• Check the probe for damage.• If necessary, replace probe.RF delivery has exceeded continuous limit• Clear error and continueLow impedance detected• Check the probe for damage.• If necessary, replace probe.Footswitch A wireless footswitch is not detected• Disconnect the wired footswitch.The footswitch icon does not appear• Ensure the unit is connected.• Ensure that there is no damage to the cable or connector.
EN-46DRAFTNote: If a disturbance occurs on the video monitor, the user should ensure that the probe cable is not near any other instrument cables.Error CodesWhen the Crossre 2 system encounters an error, it will display an error code on the LCD. Error codes are grouped into general categories that share common solutions:121. Error Code2. Category SolutionA## Activation Errors ReactivateE## System-level Errors Reboot systemP## Probe Errors Follow instructions on LCD, or replace disposable attachmentW## Warning Errors No action required; informational only
EN-47DRAFTCleaning and MaintenanceCleaningConsoleShould the console need cleaning, wipe it down with a sterile cloth and mild cleaning solution. If needed, wipe the console with a disinfectant.Warning To avoid electric shock and potentially fatal injury, unplug the Crossre2 console from the electrical outlet before cleaning.Do not sterilize the console or immerse it in any liquid. Doing so will damage the unit.Do not clean the console with alcohol, solvents, or cleaning solutions that contain ammonia. Doing so will damage the unit.FootswitchConsult the footswitch user guide for cleaning and reprocessing instructions.RF HandpieceRF handpieces are intended for single use only and should not be cleaned, sterilized, or reused.Shaver HandpieceConsult the appropriate user guide for cleaning and reprocessing instructions. Disposable attachments are intended for single use only and should not be cleaned, sterilized, or reused.MaintenanceThe Crossre2 console requires no preventative or periodic maintenance. However, Stryker recommends you reboot the system daily for best performance.
EN-48DRAFTDisposalThis product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately in accordance with applicable national or institutional related policies relating to obsolete electronic equipment.Dispose of any system accessories according to normal institutional practice relating to potentially contaminated items.
EN-49DRAFTTechnical SpecicationsStryker Endoscopy reserves the right to make improvements to the product(s) described herein. Product(s), therefore, may not agree in detail to the published design or specications. All specications are subject to change without notice. Please contact the local Stryker Endoscopy distributor or call your local Stryker Endoscopy sales representative or agent for information on changes and new products.DimensionsSize: 16.9" L × 12.5" H × 4.5" WWeight: 20 lbsEnvironmental SpecicationsOperating temperature: 5 – 40°COperating humidity: 30 – 95% RHShipping temperature: -18 – 60°CShipping humidity: 15 – 90% RHSystem Input Power RequirementsVoltage: 100-240 VAC @ 50/60Hz, 6 – 10 AInlet Fuse: 15 A, 250VElectrical SpecicationsMotor output max speed: 12000 RPMMotor duty cycle: Continuous operationRF output waveform: 200 kHz ± 1%, square wave, Crest factor <1.5 @ 200 ohms
EN-50DRAFTGenerator OutputOutput power at each set point with specied load resistance (per IEC 60601-2-2, sub clause 6.8.3) is given in the graphs below.Output Power versus Setting at 200ohms Resistive LoadOutput Power versus Setting at 200 Ohm Load050100150200250300350400Coag1Coag2Coag31 2 3 4 5 6 7 8 9 10 11Cut LevelPower (W)Output Power (CUT) versus Load ResistanceOutput Power (Cut) versus Load Resistance0501001502002503003504000 100 200 300 400 500 600 700 800 900 1000Load Resistance (ohms)(Power (W)Half Setting Full Setting
EN-51DRAFTOutput Power (COAG) versus Load ResistanceOutput Power (Coag) versus Load Resistance01020304050607080901000 100 200 300 400 500 600 700 800 900 1000Load Resistance (Ohms)Power (W)Coag 1Coag 2Coag 3Maximum Open Circuit Voltage versus Set PointMaximum Output Voltage (RMS) versus Setting050100150200250300350400Coag1Coag2Coag31234567891011Cut LevelVoltage (Vrms)
EN-52DRAFTClassicationsWarning This equipment is not suitable for use in the presence of a ammable anesthetic mixture with air, oxygen, or nitrous oxide.• Class I equipment• Type BF applied part• Degree of protection against harmful ingress of water• Generator: IEC 60601-2-2: Requirement per clause 44.3• Probe: IEC 60601-2-2: Requirement per clause 44.6• Footswitch: IEC 60601-2-2: Requirement per clause 44.6, IPX7 Water-tight EquipmentApprovalsComplies with medical safety standards:• IEC 60601-1: 1998 + A1:1991 + A2:1995• AS 3200.1.0: 1998• IEC 60601-1-2: 2001• IEC 60601-2-2: 2006• UL 60601-1: 2003• CSA C22.2 No. 601-1-M90Federal Communications Commission (FCC)FCC ID: SSH-XFC2Trade Name: Crossre2 ConsoleType or Model: 0475100000This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: 1. this device may not cause harmful interference, and 2. this device must accept any interference received, including interference that may cause undesired operation.Note: FCC regulations provide that changes or modications not expressly approved by Stryker Endoscopy could void your authority to operate this equipment.Frequency of transmission: 13.56MHzType of frequency / characteristics of the modulation: 10% ASKSubcarrier: 423.75kHz, Manchester codingEective radiated power: 50μW
EN-53DRAFTIndustry Canada (IC)IC: 4919C-XFC2Trade Name: Crossre2 ConsoleType or Model: 0475100000Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.The term “IC” before the radio certication number only signies that Industry Canada technical specications were met.
EN-54DRAFTR&TTE Declaration of Conformity (DoC)We, Name of company: Stryker EndoscopyAddress: 5900 Optical Court, San Jose, CA 95138Authorized representative: Jean-Yves CarentzContact detail of authorized representative: Stryker France, ZAC Satolas Green Pusignan, Av. de Satolas Green, 69881 MEYZIEU Cedex, FranceDeclare under our sole responsibility that the product:Product name: Crossre2 Integrated Arthroscopy SystemTrade Name: Crossre2 ConsoleType or Model: 0475100000Relevant Supplementary Information: Noneto which this declaration relates is in conformity with the essential requirements and other relevant requirements of the R&TTE Directive (1999/5/EC).e product is compliant with the following standards and/or other normative documents:Safety: EN 60601-1:1990+A1:1993+A2:1995+A13:1996 EMC: EN 60601-1-2:2007; EN 61000-3-2:2006Radio Spectrum: EN 300 330-1 V1.5.1Supplementary information: noneNotied body involved: TÜV Rheinland Product Safety (GmbH)Technical le held by: Stryker EndoscopyPlace and date of issue (of this DoC): San Jose, CA USA, August 2009Signed by or for the manufacturer:Name: K. Jerey SemoneTitle: Director, Regulatory AairsHereby, Stryker Endoscopy declares that this Short Range Device is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.
EN-55DRAFTElectromagnetic CompatibilityLike other electrical medical equipment, the Crossre2 System requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the Crossre2 System must be installed and operated according to the EMC information provided in this manual. The Crossre2 System has been designed and tested to comply with IEC 60601-1-2:2001 requirements for EMC with other devices.Warning This equipment is intended for use by health care professionals only. This equipment may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the equipment or shielding the location.Portable and mobile RF communications equipment can aect the normal function of the Crossre2 System even if such equipment meets the applicable emissions requirements.Do not use cables or accessories other than those provided with the Crossre2 System, as this may result in increased electromagnetic emissions or decreased immunity to such emissions.If the Crossre2 System is used adjacent to or stacked with other equipment, observe and verify normal operation of the Crossre2 System in the conguration in which it will be used prior to using it in a surgical procedure as interference may occur. Consult the tables below for guidance in placing the Crossre2 System.
EN-56DRAFTWhen the Crossre2 System is interconnected with other medical electrical equipment, leakage currents may be additive. To minimize total patient leakage current, any Type BF applied part should be used together with other Type BF applied parts. Any Type CF applied part should be used together with other Type CF applied parts. Ensure all systems are installed according to the requirements of IEC 60601-1-1.The separable AC power cord is provided as a means of emergency shutdown and disconnection from the power source. Do not position the console in a way that is dicult to disconnect the AC power cord. Guidance and Manufacturer’s Declaration: Electromagnetic EmissionsThe Crossre2 System is intended for use in the electromagnetic environment specied below. The customer or the user of Crossre2 System should ensure that it is used in such an environment.Emissions Test Compliance Electromagnetic Environment - GuidanceRF emissions CISPR11 Group 1 The Crossre2 System must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be aected.RF emissions CISPR11 Class A Crossre2 System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissions IEC 61000-3-2Class AVoltage Fluctuations/icker emissions IEC 61000-3-3Complies
EN-57DRAFTGuidance and Manufacturer’s Declaration: Electromagnetic ImmunityThe Crossre2 System is intended for use in the electromagnetic environment specied below. The customer or the user of Crossre2 System should ensure that it is used in such an environmentImmunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment: GuidanceElectrostatic Discharge (ESD) IEC 61000-4-2±6kV contact ±8kV air±2,4,6kV contact ±2,4,8kV airFloors should be wood, concrete, or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/burst IEC 61000-4-4±2kV for power supply lines ±1kV for input/output lines±2kV for power supply lines ±1kV for input/output linesMains power quality should be that of a typical commercial or hospital environment.Surge IEC 61000-4-5±1kV dierential mode ±2kV common mode±0.5, 1kV dierential mode ±1, 2kV common modeMains power quality 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 sec.<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 sec.Mains power quality should be that of a typical commercial or hospital environment. If the user of Crossre2 System requires continued operation during power mains interruptions, it is recommended that Crossre2 System be powered from an uninterruptible power supply or a battery.Power frequency (50/60Hz) magnetic eld IEC 61000-4-83 A/m N/A Power-frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.NOTE: Ut is the a.c. mains voltage prior to application of the test level.
EN-58DRAFTGuidance and Manufacturer’s Declaration: Electromagnetic ImmunityCrossre2 System is intended for use in the electromagnetic environment specied below. The customer or the user of Crossre2 System should ensure that it is used in such an environment.Immunity Test IEC 60601 Test LevelCompliance Level Electromagnetic Environment: Guid-ancePortable and mobile RF communications equipment should be used no closer to any part of the Crossre2 system, including its cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended Separation Distance d = 1.17 √PConducted RF IEC 61000-4-63 Vrms 150 kHz to 80 MHz3 V d = 1.17 √P 80 MHz to 800 MHzRadiated RF IEC 61000-4-33 V/m 80MHz to 2.5 GHz3 V/m d = 2.33 √P 80 MHz to 2.5 GHzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from xed RF 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 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 aected by absorption and reection from structures, objects, and people. (a) Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Crossre2 System is used exceeds the applicable RF compliance level above, the Crossre2 System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Crossre2 System.(b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
EN-59DRAFTRecommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Crossre2 SystemThe Crossre2 System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Crossre2 System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Crossre2 System as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power (W) of transmitterSeparation distance (m) according to frequency of transmitter150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz0.01 0.12 0.12 0.230.1 0.37 0.37 0.741 1.17 1.17 3.7010 3.70 2.33 7.37100 11.70 11.70 23.30For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people.Symbol GlossaryThis device and its labeling contain symbols that provide important information for the safe and proper use of the device. These symbols are dened below.Warning SymbolsWarning/Caution: See instructions for useHazardous voltage presentFront Console SymbolsPower SelectUp Down
EN-60DRAFTMENU Menu FootswitchProbe Shaver handpieceDirected energy handpieceRear Console SymbolsEquipotentiality USBStryker rewire Emits RF radiationType CF rated Protective ground earthFuse rating Compliant to CSA C22.2 No. 601.1-M90, and UL 601-1Fullls requirements of the European Medical Device Directive 93/42/EECLCD SymbolsElectrosurgical unit ContrastBrightness Sound
EN-61DRAFTPackaging/Labeling SymbolsLegal manufacturer Authorized representative in EuropeDate of manufacture Atmospheric pressure rangeAmbient temperature range Relative humidity rangeLOT Lot number Product numberSN Serial number FragileThis product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately.
EN-62DRAFT
Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-408-754-2000, 1-800-624-4422 www.stryker.comEuropean Representative: Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, FranceP13827 dra 2 2011/10DRAFT

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