Stryker Endoscopy XFC2 Crossfire 2 Console User Manual
Stryker Endoscopy Crossfire 2 Console
user manual
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| Document Description | user manual |
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| Date Submitted | 2012-05-08 00:00:00 |
| Date Available | 2012-05-08 00:00:00 |
| Creation Date | 2012-03-05 15:13:24 |
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| Document Lastmod | 2012-05-02 10:52:41 |
| Document Title | user manual |
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DRAFT Crossfire™ 2 REF 0475100000 Contents Warnings and Cautions......................................................................3 Product Description/Intended Use.................................................7 Package Contents.................................................................................8 Available Accessories............................................................................8 The Crossfire 2 Console.........................................................................9 The Crossfire 2 Interface......................................................................11 Arthroscopy Mode. ...........................................................................12 Indications for Arthroscopic Use..........................................................12 Setup and Device Connections............................................................13 Adjusting User and System Settings.....................................................17 Arthroscopic Shaver Controls...............................................................19 RF Ablation Controls...........................................................................25 Dual Controls......................................................................................30 Laparoscopy Mode............................................................................32 Indications for Laparoscopic and General Surgery Use..........................32 Setup and Device Connections............................................................33 Adjusting User and System Settings.....................................................36 Vessel Sealing Controls........................................................................38 Troubleshooting................................................................................44 Error Codes.........................................................................................46 Cleaning and Maintenance.............................................................47 Cleaning.............................................................................................47 Maintenance......................................................................................47 Disposal.............................................................................................48 Technical Specifications...................................................................49 Generator Output...............................................................................50 Electromagnetic Compatibility............................................................55 Symbol Glossary.................................................................................59 EN-1 Warnings and Cautions Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meanings and should be carefully reviewed: Warning Caution Note Warnings indicate risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user. DRAFT Cautions indicate risks to the equipment. Failure to follow cautions may result in product damage. 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. 2. 3. 4. 5. Caution: Federal law (USA) restricts this device to use by, or on order of, a physician. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. Refer any readjustments, modifications, and/or repairs to Stryker Endoscopy or its authorized representatives. Pay close attention to the care and cleaning instructions in this manual. Failure to follow these instructions may result in product damage. Install this device in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices. DO NOT use the Crossfire 2 system on patients with cardiac pacemakers or other electronic device implants. Doing so could lead to electromagnetic interference and possible death. Fire/Explosion Warnings 1. 2. DO NOT use this device in the presence of flammable anaesthetics, other flammable gases or objects, near flammable fluids such as skin prepping agents and tinctures, or oxidizing agents. Observe appropriate fire precautions at all times. 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-3 3. 4. Electrosurgical components, such as the probe, may remain hot following activation. Keep all electrosurgical equipment away from flammable materials to avoid combustion. To prevent the risk of fire, DO NOT replace console fuses. If it is suspected that fuses are damaged, return console to Stryker for repair. Prior to Surgery 1. DRAFT The operator of the Crossfire 2 system should be a qualified 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 Crossfire 2 system should be experienced in arthroscopic and electrosurgical practices and techniques. 3. The operator of the Crossfire 2 system should read this manual thoroughly and be familiar with its contents prior to operating the equipment. 4. The operator of the Crossfire 2 system should be sure that the system functions as outlined in this manual prior to a surgical procedure. The Crossfire 2 system was fully tested at the factory before shipment. 5. Crossfire 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 Crossfire 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 flow of air away from the patient. 11. When the Crossfire 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-4 monitoring 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 Surgery 1. DO NOT use the Crossfire 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 Crossfire 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 Crossfire 2 system is activated, the conducted and radiated electrical fields 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 field 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 fluids. 9. DO NOT activate the Crossfire 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 field 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-5 DRAFT 13. 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 Surgery 1. 2. 3. 4. 5. DRAFT 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. DO NOT use flammable agents for cleaning and disinfection of the Crossfire 2 console, handpiece, or footswitch. DO NOT remove the cover of the console as this could cause electric shock and product damage. Attempt no internal repairs or adjustments, unless specified otherwise in this manual. Units requiring repair should be returned to Stryker. Disconnect the Crossfire 2 system from the electrical output when inspecting fuses. EN-6 Product Description/Intended Use The Crossfire 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 Crossfire 2 system consists of the following components: DRAFT 1. Crossfire 2 Console (featured in this manual) • Acts as a connection hub for the various components of the Crossfire 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 Crossfire 2 system 2. Disposable RF probe Enables RF cutting and coagulation 3. Powered shaver handpiece (and disposable attachments) Enables arthroscopic cutting and debridement 4. Crosseal Handpiece Enables vessel sealing 5. Crossfire Footswitch Provides remote, foot control of the powered shaver handpiece and RF probe EN-7 Package Contents Carefully unpack the Crossfire 2 console and inspect each of the following components. Report any damaged components to Stryker. (1) Crossfire 2 console (1) Hospital-grade power cord (1) User guide DRAFT Available Accessories The Crossfire 2 system is compatible with the following accessories: System Accessories 0475-000-100 Crossfire Footswitch 0277-200-100 iSWITCH Universal Wireless Footswitch Receiver 0277-200-101 iSWITCH Universal Wireless Footswitch Receiver (AUS) 0277-100-100 iSWITCH Universal Wireless Footswitch 6000-001-020 Stryker firewire cable Arthroscopy Accessories 0279-xxx-xxx SERFAS Energy family of electrosurgical probes 0375-708-500 Formula 180 Handpiece 0375-704-500 Formula Handpiece (with buttons) 0375-701-500 Formula Handpiece (without buttons) 0275-601-500 Small-Joint Shaver Handpiece Laparoscopy Accessories 0250-080-800 35 cm Crosseal Vessel Sealing Handpiece 0250-080-850 45 cm Crosseal Vessel Sealing Handpiece EN-8 The Crossfire 2 Console The Crossfire 2 console is the connection hub for the components of the Crossfire 2 system. It generates RF energy for ablation and vessel sealing, powers motorized shavers, and provides user controls and system feedback. Front Panel The front console panel features ports for connecting handpieces, controls for adjusting handpiece settings, and an LCD screen to provide system feedback. DRAFT CROSSFIRE II INTEGRATED RESECTION AND SEALING SYSTEM 1. Menu Selects menu items 2. 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 handpieces 4. Handpiece connector Powered shaver handpiece 5. Power Powers the console on and off 6. Error indicator Shines red to indicate errors (error details appear in the LCD) 7. LCD screen Provides system feedback 8. Adjust Adjusts options for connected devices 9. Footswitch connector Crossfire Footswitch EN-9 Rear Panel The rear panel provides ports for connecting the console to other Stryker equipment. 3 4 DRAFT 1. Firewire Connectors Enables connection to other Stryker Firewire devices, such as the iSWITCH Universal Wireless Footswitch 2. USB Drive Enables software installation from authorized service personnel 3. Equipotential Ground Plug — 4. AC Power Inlet — EN-10 The Crossfire 2 Interface The Crossfire 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 Crossfire Footswitch. DRAFT Control Description 1. Menu The Menu button opens a menu for selecting user and system settings. 2. Error indicator The 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 Crossfire 2 interface. 5. Adjust The Adjust buttons increase/decrease speed and power settings for the selected device. EN-11 Arthroscopy Mode Indications for Arthroscopic Use The Stryker Crossfire 2 system is indicated for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The crossfire 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. DRAFT Contraindications The 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-12 Setup and Device Connections Stryker Endoscopy considers instructional training an integral part of the Crossfire 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 staff on its operation and maintenance. Please contact your local Stryker Endoscopy representative to schedule an in-service after your equipment has arrived. Warning DRAFT 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 field. The Crossfire 2 System is compatible only with the Stryker handpieces and footswitches listed in this manual. Do not connect any equipment not specified in this manual, as unexpected results or serious injury will occur. EN-13 1. • • 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. DRAFT 2. Connect the AC power. 3. Connect the handpieces and footswitch. (Note: Vessel sealing handpieces are not intended to be connected during arthroscopic procedures.) ING SYSTEM The console will display an error message if expired or used attachments are connected: 4. EN-14 Connect suction tubing (for all suction-capable devices). Using the iSWITCH Wireless Footswitch The Crossfire 2 system can be used with the iSWITCH Wireless Footswitch System. DRAFT 1. Connect the Crossfire 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 1000400-700) for further operation instructions. EN-15 Powering the Console On and Off Press the power button to power the console on and off. The button will shine green when the console is on. Warning EN-16 DRAFT Should emergency shutdown become necessary, power off 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 Settings User Preference Settings User preferences, such as power and cutting speeds and button assignments for the handpiece and footswitch, can be adjusted through the Crossfire 2 interface. Select from the default settings provided with the console, or contact your Stryker representative to customize your own. DRAFT 1. Press 2. Press to select a default setting. 3. Press to confirm selection and exit. Or, press selection. DEFAULT SMITH KNEE SMITH SHLDR to cancel Note: User preference settings will not take effect unless a disposable attachment is connected to the shaver. EN-17 System Settings System settings, such as screen brightness, contrast, and system sound can be adjusted through the Crossfire 2 interface. 1. Press and hold (Note: If an RF probe is connected to the console, the COAG adjustment DRAFT again to screen will appear. Press access the system settings screen.) 2. Press to choose (contrast), (brightness), or (sound). (The will indicate your selection.) 3. Press 4. Press and hold to adjust. to exit. (Note: A short press will display the current version of the console software.) EN-18 Arthroscopic Shaver Controls Warning The Crossfire 2 system is intended for use only by licensed medical professionals, properly trained in the use of electrosurgical equipment and techniques. The Crossfire 2 system generates potentially hazardous levels of energy that can result in injury or even death if improperly used. Before using the Crossfire 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 effect, or product damage. DRAFT 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, first 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-19 Default Handpiece Controls 1. Default 1 Default 2 / None Default 3 Oscillate (one touch) Activate / Deactivate Oscillate (one touch) TOUCH TOUCH DRAFT 2. Forward (one touch) TOUCH 3. Reverse (one touch) TOUCH Select Mode: Oscillate or Forward / Reverse Jog Forward/ Reverse Forward (one touch) TOUCH Note: Default settings can be selected in the User Preference Settings screen on the console. Settings will not take effect until a disposable attachment is connected to the shaver handpiece. EN-20 Default Footswitch Controls The RF and shaver handpieces can also be controlled by the Crossfire Footswitch. The default footswitch controls for the shaver handpiece are shown below. To customize button assignments, contact your Stryker representative. DRAFT Button Function Default 1 Default 2 / None Default 3 Jog Select Mode: Oscillate or Forward/Reverse Select Mode: Oscillate or Forward/Reverse II Select Handpiece: RF or Shaver Select Handpiece: RF or Shaver Select Handpiece: RF or Shaver III Select Direction: Forward or Reverse Select Speed: High or Low Select Speed: High or Low Oscillate (fixed) Oscillate/Reverse (variable) Oscillate/Reverse (fixed) FIXED VAR FIXED Forward/Reverse (variable) Oscillate/Forward (variable) Oscillate/Forward (fixed) VAR VAR FIXED EN-21 Note: When using small-joint handpieces, only Default 2 settings are available. No other defaults or user preferences can be applied. Adjusting Cutting Speed Use 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 identification (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 affect the other. DRAFT EN-22 Reading the LCD In shaver mode, the LCD will show: 9000 VAR DRAFT MC DISP NAME 1. Footswitch status Crossfire Footswitch connected iSWITCH footswitch connected not connected 2. Footswitch response TOUCH FIXED VAR one touch (pressing the foot pedal once will activate the shaver to a default speed; pressing again will stop it) fixed (pressing the foot pedal at any pressure will result in a constant speed) variable (shaver speed will vary, depending on the pressure applied to the foot pedal) mix (oscillate speed is fixed; forward/reverse speed is variable) 3. Direction forward R reverse oscillate 4. Cutter name 5. Speed (name) (#) rotations per minute EN-23 System Feedback Event Audible Feedback Visible Feedback (via LCD) Reverse activated five high beeps Forward activated/ resumed low beep Adjustments made to speed settings one beep for each unit of change DRAFT EN-24 Speed indicator number increases or decreases RF Ablation Controls 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, first power down the system to ensure the readings are not the result of system noise. DRAFT RF and Crosseal handpieces are intended for single use only and should not be reprocessed or reused. Default handpiece controls 1. Adjust CUT power level (single press) or Activate/deactivate Force Modulation (press and hold for three seconds) 2. Activate CUT 3. Activate COAG EN-25 Default footswitch controls The RF and shaver handpieces can also be controlled by the Crossfire Footswitch. The default footswitch controls for the RF probe are shown below. To customize button assignments, contact your Stryker representative. DRAFT EN-26 Button Function (controls are the same for defaults 1, 2, and 3) Decrease Cut Level II Select Handpiece: RF or Shaver III Increase Cut Level Cut Coag Adjusting CUT power To 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 footswitch Adjusting COAG power DRAFT To adjust COAG power: 1. Press and hold . The COAG POWER LEVEL screen will appear. COAG1 COAG2 COAG3 COAG POWER LEVEL 2. Press 3. Press to adjust. to confirm selection and exit. Note: COAG power can only be adjusted when an RF probe is connected to the console. Selecting Force Modulation The Crossfire 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-27 Reading the LCD In RF ablation mode, the LCD will show: 11 DRAFT . . . HC SERFAS 1. Footswitch status Crossfire Footswitch connected iSwitch footswitch connected not connected 2. Mode cut mode activated coagulation mode activated 3. Force modulation force modulation activated force modulation not activated 4. COAG power low medium high 5. Hand controls hand control is enabled hand control is disabled 6. CUT power (#) 7. Disposable RF probe name (name) EN-28 power setting System Feedback Event Audible Feedback CUT activated high, steady tone COAG activated low, steady tone Visible Feedback (via LCD) DRAFT Force modulation on / off Single beep System error Ten short beeps Adjustments made to power settings one beep for each unit of change CUT power indicator number increases or decreases Change footswitch to control RF mode “SERFAS” “SERFAS” appears Change footswitch to control Shaver mode “Shaver” disposable name appears EN-29 Dual Controls In arthroscopic procedures, RF probes and arthroscopic shaver handpieces can be simultaneously connected to the Crossfire 2 system, enabling users to toggle quickly between RF ablation and arthroscopic functions. Selecting between RF Ablation Mode and Arthroscopic Shaver Mode for Footswitch Control DRAFT Selecting 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 Crossfire 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 identified 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 handpiece To 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 identified by handpiece appears on the right side of the LCD.) EN-30 Reading the LCD In 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. 9000 Dual mode, shaver handpiece controlled by footswitch. 9000 11 Dual mode, RF probe controlled by footswitch. 11 FIXED DRAFT SERFAS FIXED MC DISP NAME MC DISP NAME SERFAS Adjusting handpiece settings with the console In 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-31 Laparoscopy Mode Indications for Laparoscopic and General Surgery Use The Stryker Crossfire 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 fit in the jaws of the instruments. DRAFT Contraindications • • • The system should not be used with atherosclerotic vessels (calcified 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-32 Setup and Device Connections Stryker Endoscopy considers instructional training an integral part of the Crossfire 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 staff on its operation and maintenance. Please contact your local Stryker Endoscopy representative to schedule an in-service after your equipment has arrived. Warning DRAFT 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 field. The Crossfire 2 System is compatible only with the Stryker handpieces and footswitches listed in this manual. Do not connect any equipment not specified in this manual, as unexpected results or serious injury will occur. EN-33 1. • • 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. DRAFT 2. Connect the AC power. 3. Connect the handpiece and footswitch. (Note: Arthroscopic handpieces are not intended to be connected during laparoscopic procedures.) ION AND SEALING SYSTEM EN-34 Using the iSWITCH Wireless Footswitch The Crossfire 2 system can be used with the iSWITCH Wireless Footswitch System. DRAFT 1. Connect the Crossfire 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 1000400-700) for further operation instructions. Powering the Console On and Off Press the power button to power the console on and off. The button will shine green when the console is on. EN-35 Warning Should emergency shutdown become necessary, power off 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 Settings DRAFT User Preference Settings User preferences, such as button assignments for the handpiece and footswitch, can be adjusted through the Crossfire 2 interface. Select from the default settings provided with the console, or contact your Stryker representative to customize your own. 1. Press 2. Press to select a default setting. 3. Press to confirm selection and exit. Or, press selection. EN-36 DEFAULT SMITH KNEE to cancel SMITH SHLDR System Settings System settings, such as screen brightness, contrast, and system sound can be adjusted through the Crossfire 2 interface. 1. Press and hold 2. Press DRAFT to choose (brightness), or (contrast), (sound). (The will indicate your selection.) 3. Press 4. Press and hold to adjust. to exit. (Note: A short press will display the current version of the console software.) EN-37 Vessel Sealing Controls Warning The Crossfire 2 system is intended for use only by licensed medical professionals, properly trained in the use of electrosurgical equipment and techniques. The Crossfire 2 system generates potentially hazardous levels of energy that can result in injury or even death if improperly used. DRAFT Before using the Crossfire 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 effect, 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, first 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-38 Default Handpiece Controls DRAFT 1. grasp 2. seal 3. cut (mechanically) Note: For complete instructions on how to use the Crosseal handpiece, consult the Crosseal Handpiece User Guide (P17278). EN-39 Default footswitch controls The RF and shaver handpieces can also be controlled by the Crossfire Footswitch. The default footswitch controls for the vessel sealing handpiece are shown below. To customize button assignments, contact your Stryker representative. DRAFT EN-40 Button Function (controls are the same for defaults 1, 2, and 3) Decrease Seal Level II Select Handpiece: RF, Crosseal, or Shaver III Increase Seal Level Activate/Seal Activate/Seal Reading the LCD In vessel sealing mode, the LCD will show: SEAL DRAFT HC VESSEL SEALER 1. Progress indicator indicates progress of vessel sealing 2. Footswitch status Crossfire Footswitch connected iSwitch footswitch connected not connected 3. Sealing status SEAL vessel sealing in progress vessel sealing not in progress 4. Seal power 5. Hand controls 6. Handpiece indicator (#) power setting hand control is connected and its buttons are active vessel sealing handpiece is connected EN-41 System Feedback Event Audible Feedback Sealing activated / in progress steady tone Visible Feedback (via LCD) SEAL DRAFT progress bar Sealing complete two high beeps SEAL progress bar Sealing error alternating high/low tones vessel-sealing error EN-42 Vessel-Sealing Errors During vessel sealing, the Crossfire 2 system will indicate sealing progress. Should a seal be unsuccessful, the LCD will display an appropriate error message: DRAFT 1. Error Code 2. Description A1 No Vessel Found A2 Incomplete Seal A3 Incomplete Seal Solution Regrasp tissue and retry seal EN-43 Troubleshooting Problem Console Possible Solution A hardware fault is • detected • Turn the power off and on again. If the problem persists, contact a Stryker representative or return the console for repair. DRAFT 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 • • • • EN-44 Power down all electrical equipment not in use. Increase distance of other electrical equipment. Connect the unit and other equipment into different outlets. The generator • temperature is too high Ensure that there is proper airflow around the unit. A power-on self test error has occurred Turn the power off and on again. If the problem persists, contact a Stryker representative or return the console for repair. • • Handpiece The temperature is higher than normal • Allow the unit to cool before restarting. The unit has reached its recommended service interval • Contact your Stryker representative. DRAFT Disposable Attachments Footswitch RF probe is not ready • Check the connection to the console. RF probe is expired • Replace probe. RF probe identification is invalid • Replace probe. RF probe communication error • • Check the connection to the console. If necessary, replace probe. Exceeded time usage • Replace probe RF 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 continue Low impedance detected • • Check the probe for damage. If necessary, replace probe. 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-45 Note: If a disturbance occurs on the video monitor, the user should ensure that the probe cable is not near any other instrument cables. Error Codes When the Crossfire 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: DRAFT 1. Error Code 2. Category Solution A## Activation Errors Reactivate E## System-level Errors Reboot system P## Probe Errors Follow instructions on LCD, or replace disposable attachment W## Warning Errors No action required; informational only EN-46 Cleaning and Maintenance Cleaning Console DRAFT Should 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 Crossfire 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. Footswitch Consult the footswitch user guide for cleaning and reprocessing instructions. RF Handpiece RF handpieces are intended for single use only and should not be cleaned, sterilized, or reused. Shaver Handpiece Consult 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. Maintenance The Crossfire 2 console requires no preventative or periodic maintenance. However, Stryker recommends you reboot the system daily for best performance. EN-47 Disposal This 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. DRAFT EN-48 Technical Specifications Stryker 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 specifications. All specifications 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. DRAFT Dimensions Size: Weight: 16.9" L × 12.5" H × 4.5" W 20 lbs Environmental Specifications Operating temperature: Operating humidity: Shipping temperature: Shipping humidity: 5 – 40°C 30 – 95% RH -18 – 60°C 15 – 90% RH System Input Power Requirements Voltage: Inlet Fuse: 100-240 VAC @ 50/60Hz, 6 – 10 A 15 A, 250V Electrical Specifications Motor output max speed: 12000 RPM Motor duty cycle: Continuous operation RF output waveform: 200 kHz ± 1%, square wave, Crest factor <1.5 @ 200 ohms EN-49 Generator Output Output power at each set point with specified load resistance (per IEC 606012-2, sub clause 6.8.3) is given in the graphs below. Power versus at Setting at 200 Ohm Load Output Power Output versus Setting 200ohms Resistive Load 400 DRAFT 350 Power (W) 300 250 200 150 100 50 Coag Coag Coag 10 11 Cut Level (Cut) versus Load Resistance Output Power Output (CUT)Power versus Load Resistance 400 350 (Power (W) 300 Half Setting 250 Full Setting 200 150 100 50 100 200 300 400 500 600 Load Resistance (ohms) EN-50 700 800 900 1000 Power (Coag)Load versusResistance Load Resistance Output PowerOutput (COAG) versus 100 90 Power (W) 80 70 Coag 1 60 Coag 2 Coag 3 50 40 30 20 10 DRAFT 100 200 300 400 500 600 700 800 900 1000 Load Resistance (Ohms) Maximum Output Voltage (RMS) versus Setting Maximum Open Circuit Voltage versus Set Point 400 350 Voltage (Vrms) 300 250 200 150 100 50 Coag Coag Coag 10 11 Cut Level EN-51 Classifications Warning This equipment is not suitable for use in the presence of a flammable 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 Equipment DRAFT Approvals Complies 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-M90 Federal Communications Commission (FCC) FCC ID: SSH-XFC2 Trade Name: Crossfire 2 Console Type or Model: 0475100000 This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: 1. 2. this device may not cause harmful interference, and this device must accept any interference received, including interference that may cause undesired operation. Note: FCC regulations provide that changes or modifications not expressly approved by Stryker Endoscopy could void your authority to operate this equipment. Frequency of transmission: 13.56MHz Type of frequency / characteristics of the modulation: 10% ASK Subcarrier: 423.75kHz, Manchester coding Effective radiated power: 50μW EN-52 Industry Canada (IC) IC: 4919C-XFC2 Trade Name: Crossfire 2 Console Type or Model: 0475100000 Operation 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. DRAFT The term “IC” before the radio certification number only signifies that Industry Canada technical specifications were met. EN-53 R&TTE Declaration of Conformity (DoC) We, Name of company: Stryker Endoscopy Address: 5900 Optical Court, San Jose, CA 95138 Authorized representative: Jean-Yves Carentz Contact detail of authorized representative: Stryker France, ZAC Satolas Green Pusignan, Av. de Satolas Green, 69881 MEYZIEU Cedex, France DRAFT Declare under our sole responsibility that the product: Product name: Crossfire 2 Integrated Arthroscopy System Trade Name: Crossfire 2 Console Type or Model: 0475100000 Relevant Supplementary Information: None to which this declaration relates is in conformity with the essential requirements and other relevant requirements of the R&TTE Directive (1999/5/EC). The 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 61000-3-2:2006 Radio Spectrum: EN 300 330-1 V1.5.1 Supplementary information: none Notified body involved: TÜV Rheinland Product Safety (GmbH) Technical file held by: Stryker Endoscopy Place and date of issue (of this DoC): San Jose, CA USA, August 2009 Signed by or for the manufacturer: Name: K. Jeffrey Semone Title: Director, Regulatory Affairs Hereby, 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-54 Electromagnetic Compatibility Like other electrical medical equipment, the Crossfire 2 System requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the Crossfire 2 System must be installed and operated according to the EMC information provided in this manual. The Crossfire 2 System has been designed and tested to comply with IEC 60601-1-2:2001 requirements for EMC with other devices. Warning DRAFT 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 affect the normal function of the Crossfire 2 System even if such equipment meets the applicable emissions requirements. Do not use cables or accessories other than those provided with the Crossfire 2 System, as this may result in increased electromagnetic emissions or decreased immunity to such emissions. If the Crossfire 2 System is used adjacent to or stacked with other equipment, observe and verify normal operation of the Crossfire 2 System in the configuration 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 Crossfire 2 System. EN-55 When the Crossfire 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 difficult to disconnect the AC power cord. DRAFT Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The Crossfire 2 System is intended for use in the electromagnetic environment specified below. The customer or the user of Crossfire 2 System should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF emissions CISPR11 Group 1 The Crossfire 2 System must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF emissions CISPR11 Class A Harmonic emissions IEC 610003-2 Class A Voltage Fluctuations/flicker emissions IEC 61000-3-3 Complies Crossfire 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. EN-56 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The Crossfire 2 System is intended for use in the electromagnetic environment specified below. The customer or the user of Crossfire 2 System should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment: Guidance Electrostatic Discharge (ESD) IEC 61000-4-2 ±6kV contact ±8kV air ±2,4,6kV contact ±2,4,8kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. DRAFT 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 lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1kV differential mode ±2kV common mode ±0.5, 1kV differential mode ±1, 2kV common mode Mains 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 Crossfire 2 System requires continued operation during power mains interruptions, it is recommended that Crossfire 2 System be powered from an uninterruptible power supply or a battery. Power frequency (50/60Hz) magnetic field IEC 61000-4-8 3 A/m N/A Power-frequency magnetic fields 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-57 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Crossfire 2 System is intended for use in the electromagnetic environment specified below. The customer or the user of Crossfire 2 System should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment: Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Crossfire 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 √P Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 DRAFT 3 Vrms 150 kHz to 80 MHz 3V d = 1.17 √P 80 MHz to 800 MHz 3 V/m 80MHz to 2.5 GHz 3 V/m d = 2.33 √P 80 MHz to 2.5 GHz where 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 fixed 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 affected by absorption and reflection from structures, objects, and people. (a) Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Crossfire 2 System is used exceeds the applicable RF compliance level above, the Crossfire 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 Crossfire 2 System. (b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. EN-58 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Crossfire 2 System The Crossfire 2 System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Crossfire 2 System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Crossfire 2 System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power (W) of transmitter 0.01 0.1 10 100 Separation distance (m) according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz DRAFT 0.12 0.12 0.23 0.37 0.37 0.74 1.17 1.17 3.70 3.70 2.33 7.37 11.70 11.70 23.30 For 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 affected by absorption and reflection from structures, objects, and people. Symbol Glossary This device and its labeling contain symbols that provide important information for the safe and proper use of the device. These symbols are defined below. Warning Symbols Warning/Caution: See instructions for use Hazardous voltage present Front Console Symbols Power Select Up Down EN-59 MENU Menu Footswitch Probe Shaver handpiece Directed energy handpiece DRAFT Rear Console Symbols Equipotentiality USB Stryker firewire Emits RF radiation Type CF rated Protective ground earth Fuse rating Compliant to CSA C22.2 No. 601.1-M90, and UL 601-1 Fulfills requirements of the European Medical Device Directive 93/42/EEC LCD Symbols EN-60 Electrosurgical unit Contrast Brightness Sound Packaging/Labeling Symbols Legal manufacturer Authorized representative in Europe Date of manufacture Atmospheric pressure range DRAFT Ambient temperature range Relative humidity range LOT Lot number Product number SN Serial number Fragile This product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately. EN-61 DRAFT EN-62 DRAFT Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-408-754-2000, 1-800-624-4422 www.stryker.com European Representative: Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, France P13827 draft 2 2011/10
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