Stryker Endoscopy XFC An integrated arthroscopy resection console. User Manual Cover Page

Stryker Endoscopy An integrated arthroscopy resection console. Cover Page

Contents

User Manual

Stryker Endoscopy 5900 Optical Court, San Jose, CA 95138 APPROVALS DATE TITLE DRAWN BY: A. Infanger 05/15/09 ORIGINATOR C. Bennett 05/19/09 Crossfire Console User Guide (English) SIZE REV. DOCUMENT NO. SHEET OF A E 1000-401-036 1 48 REVISIONS REVISIONS LTR ECN NO. DATE APPROVED LTR ECN NO. DATE APPROVED A ECO116602 02/17/09 R. Cardenas B 45458 03/05/09 R. Cardenas C 45524 03/12/09 C. Bennett D ECO30971 04/22/09 C. Bennett E ECO31369 05/19/09 C. Bennett F G H J K L M N P R T U V W Y Printing Instructions 1. Print 5.5 w × 8.5 h 2. Black and white 3. Front and back 4. Select binding and paper weight based on cost Global Source Archive this document as a user guide (not a service or maintenance manual). Languages This document is translated into the following languages: 1. English
Crossfire™ ConsoleREF 0475000000User Guide
ContentsWarnings and Cautions ..............................................................5Symbol Glossary ............................................................................9Product Description and Intended Use ..........................11Indications/Contraindications ..........................................................12Package Contents ...........................................................................12Available Accessories ......................................................................12The Crossre™ Console ..................................................................13Setup and Interconnection ....................................................15Electromagnetic Compatibility .........................................................15Connections .....................................................................................20Powering the Console On and Off ...................................................22Operation .........................................................................................23The Crossre™ Interface .................................................................24Adjusting User and System Settings ...............................................25Reading the LCD Screen .................................................................27Selecting Between RF and Shaver Modes ......................................30Adjusting Power and Speed Settings ..............................................30Using the Handpiece .......................................................................31Using the Footswitch .......................................................................32Audible Feedback ............................................................................36Troubleshooting ...........................................................................37Cleaning and Maintenance ....................................................39Cleaning ...........................................................................................39Disposal ...........................................................................................40Technical Specifications .........................................................41Generator Output .............................................................................42
EN-5Warnings and CautionsPlease read this manual and follow its instructions carefully. e 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. e warranty is void if any of these warnings is disregarded.1. 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™ 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 (NO) atmospheres, or in the presence of other oxidizing agents, to prevent risk of explosion. Ensure that oxygen connections are not leaking.
EN-63. 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. e operator of the Crossre™ 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 electrosurgical procedures.2. e operator of the Crossre™ system should be experienced in arthroscopic and electrosurgical practices and techniques.3. e operator of the Crossre™ system should read this manual thoroughly and be familiar with its contents prior to operating the equipment.4. e operator of the Crossre™ system should be sure that the system functions as outlined in this manual prior to a surgical procedure. e Crossre™ system was fully tested at the factory before shipment. 5. Crossre™ 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™ 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™ 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 monitoring electrodes are NOT recommended.
EN-712. 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™ 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. e use of antistatic sheeting is recommended for this purpose.3. DO NOT activate the Crossre™ 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™ 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™ 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. e 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.13. DO NOT obstruct the fan (located near the rear of the console).
EN-814. 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™ 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™ system from the electrical output when inspecting fuses.
EN-9Symbol Glossaryis device and its labeling contain symbols that provide important information for the safe and proper use of the device. ese symbols are dened below.Warning SymbolsWarning/Caution: See instructions for useHazardous voltage presentFront Console SymbolsPower SelectUp DownMENU Menu FootswitchProbe HandpieceRear Console SymbolsEquipotentiality USBStryker rewire Emits RF radiationType BF rated Protective ground earth
EN-10Fuse rating Compliant to CSA C22.2 No. 601.1-M90, and UL 601-1UL classied Fullls requirements of the European Medical Device Directive 93/42/EECLCD SymbolsElectrosurgical unit ContrastBrightness SoundPackaging/Labeling SymbolsLegal manufacturer Authorized representative in EuropeDate of manufacture Atmospheric pressure rangeAmbient temperature range Relative humidity rangeLOTLot number Product numberSNSerial number Fragileis product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately.
EN-11Product Description and Intended Usee Crossre™ Integrated Arthroscopy System is a combination powered shaver system/electrosurgical generator, intended for use in arthroscopic and orthopedic procedures. Illustrated below, the Crossre™ system consists of the following components:21341. Crossre™ Console (featured in this manual)• Actsasaconnectionhubforthevariouscomponents of the Crossre™ system• Powersamotorizedshaverhandpieceforthe mechanical cutting and debridement of bone and so tissue• Generatesbipolarradiofrequency(RF)energy for the electrosurgical cutting and coagulation of tissue• Providesacentraluserinterfaceforoperating the Crossre™ system2. Disposable RF probe Enables RF cutting and coagulation3. Powered shaver handpiece (and disposable attachments)Enables arthroscopic cutting and debridement4. Crossre™ Footswitch Provides remote, foot control of the powered shaver handpiece and RF probe
EN-12Indications/Contraindicationse Crossre™ system is indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow, wrist, and hip. e Crossre™ System provides abrasion, resection, debridement, and removal of bone and so tissue through its shaver blade, and the ablation and coagulation of so tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the product include resection, ablation, and coagulation of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.e electrosurgical probe is contraindicated for use in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.Package ContentsCarefully unpack the Crossre™ console and inspect each of the following components. Report any damaged components to Stryker. (1) Crossre™ console (1) Hospital-grade power cord (0105-003-001)(1) User guideAvailable Accessoriese Crossre™ system is compatible with the following accessories:0279-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 Handpiece0277-200-100 iSWITCH™ Universal Wireless Footswitch Receiver0277-100-100 iSWITCH™ Universal Wireless Footswitch6000-001-020 Stryker rewire cable
EN-13The Crossfire™ Consolee Crossre™ console is the connection hub for the components of the Crossre™ system. It generates RF energy, powers motorized shavers, and provides user controls and system feedback. Front Panele front console panel features ports for connecting handpieces, controls for adjusting handpiece settings, and an LCD screen to provide system feedback.1 25 6 7 8 93 41. Menu Selects menu items2. Select Selects which device displays on the LCD screen.3. RF connector SERFAS Energy probe4. 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-14Rear Panele rear panel provides ports for connecting the console to other Stryker equipment. 9 10 11 129. Firewire Connectors Enables connection to other Stryker Firewire devices, such as the iSWITCH Universal Wireless Footswitch10. USB Drive Enables uploading of preset user settings11. Equipotential Ground Plug—12. AC Power Inlet —
EN-15Setup and InterconnectionStryker Endoscopy considers instructional training an integral part of the Crossre™ 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 aer your equipment has arrived.Electromagnetic CompatibilityLike other electrical medical equipment, the Crossre™ System requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the Crossre™ System must be installed and operated according to the EMC information provided in this manual. e Crossre™ System has been designed and tested to comply with IEC 60601-1-2:2001 requirements for EMC with other devices.Warning is equipment is intended for use by health care professionals only. is 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™ System even if such equipment meets the applicable emissions requirements.e Crossre™ System was not tested for immunity to electromagnetic disturbances.Do not use cables or accessories other than those provided with the Crossre™ System, as this may result in increased electromagnetic emissions or decreased immunity to such emissions.
EN-16If the Crossre™ System is used adjacent to or stacked with other equipment, observe and verify normal operation of the Crossre™ 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™ System.When the Crossre™ 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. Ensure all systems are installed according to the requirements of IEC 60601-1-1.e 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™ System is intended for use in the electromagnetic environment specied below. The customer or the user of Crossre™ System should ensure that it is used in such an environment.Emissions Test Compliance Electromagnetic Environment - GuidanceRF emissions CISPR11Group 1 The Crossre™ System must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.RF emissions CISPR11Class A Crossre™ 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-17Guidance and Manufacturer’s Declaration: Electromagnetic ImmunityThe Crossre™ System is intended for use in the electromagnetic environment specied below. The customer or the user of Crossre™ System should ensure that it is used in such an environmentImmunity Test IEC 60601 Test LevelCompliance 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 differential mode ±2kV common mode±0.5, 1kV differential 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™ System requires continued operation during power mains interruptions, it is recommended that Crossre™ 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-18Guidance and Manufacturer’s Declaration: Electromagnetic ImmunityCrossre™ System is intended for use in the electromagnetic environment specied below. The customer or the user of Crossre™ System should ensure that it is used in such an environment.Immunity Test IEC 60601 Test LevelCompliance Level Electromagnetic Environment: GuidancePortable and mobile RF communications equipment should be used no closer to any part of the Crossre™ 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 affected 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™ System is used exceeds the applicable RF compliance level above, the Crossre™ 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™ System.(b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
EN-19Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Crossre™ SystemThe Crossre™ System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Crossre™ System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Crossre™ 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 affected by absorption and reection from structures, objects, and people.
EN-20ConnectionsWarning 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. e console and footswitch are not sterile devices and should not enter the sterile eld. e Crossre™ 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-211. 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.3. Connect the handpieces and footswitch.4. Connect suction tubing (for all suction-capable devices).
EN-22Powering the Console On and OffPress the power button to power the console on and o. e 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-23Operatione Crossre™ interface displays system status, enables you to choose between RF 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. Warning e Crossre™ system is intended for use only by licensed medical professionals, properly trained in the use of electrosurgical equipment and techniques. e Crossre™ system generates potentially hazardous levels of energy that can result in injury or even death if improperly used. Before using the Crossre™ 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.
EN-24The Crossfire™ Interface1 3 42Control Description See1. Menu The Menu button sets user and system settings. “Adjusting User and System Settings”2. LCD screen e LCD screen displays system status, error codes, mode of operation, cutting speed, and power levels. “Reading the LCD Screen”3. Select e Select button toggles between RF and Shaver controls. e selected device can then be controlled using the Crossre™ interface. “Selecting Between RF and Shaver Modes”4. Adjust e Adjust buttons increase/decrease speed and power settings for the selected device. “Adjusting Power and Speed Settings”
EN-25Adjusting 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™ 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. Note: When using small-joint handpieces, system defaults will take eect (see “Default Shaver Controls”). No user preferences can be applied.
EN-26System SettingsSystem settings, such as screen brightness, contrast, and system sound can be adjusted through the Crossre™ interface.1. Press and hold .2. Press to choose (contrast), (brightness), or (sound). 3. Press to adjust.4. Press and hold to exit. (Note: A short press will display the current version of the console software.)
EN-27Reading the LCD Screene LCD screen displays the devices that are connected to the console and their current status. RF ModeIn RF mode, the LCD will show:11SERFAS123541. Footswitch status Crossre footswitch connectediSwitch footswitch connectednot connected2. Mode cut modecoagulation mode3. Force modulation force modulation activatedforce modulation not activated4. Probe name (name)5. Power (#) power setting
EN-28Shaver ModeIn shaver mode, the LCD will show:VARF9000MC DISP NAME1 23 541. Footswitch status Crossre footswitch connectediSWITCH footswitch connectednot connected2. Button response 1TOUCH one touch(pressing the shaver button once will activate the shaver to a default speed; pressing again will stop it)FIXED xed(pressing the shaver button at any pressure will result in a constant speed)VARvariable (for small-joint handpieces)(shaver speed will vary, depending on the pressure applied to the shaver button)3. Direction FforwardRreverseoscillate4. Cutter name (name)5. Speed (#) rotations per minute
EN-29Dual ModeIn dual mode, the LCD will show the status of both devices. e shaver status will always appear to the right, except during adjustments to RF settings. To select between RF and shaver modes, press .F9000FIXED11SERFASMCDISP NAMEDual mode, normal screen.F9000FIXED 11SERFASMC DISP NAMEDual mode, adjustments being made to RF power settingse screen will revert to normal aer 5 seconds of inactivity.
EN-30Selecting Between RF and Shaver ModesTo select the appropriate mode, do one of the following:• Press on the Crossre interface. e interface will toggle between modes.• Pressthemodebuttononthefootswitch.• Pressanybuttononthedesiredhandpiece.Adjusting Power and Speed SettingsUse the buttons on the console to manually adjust the power or speed setting for the active handpiece. Note: Forward and reverse settings are adjusted independent of each other. Adjusting settings in one mode will not aect the other.Note: In RF mode, power can also be adjusted with the buttons on the handpiece or footswitch.Note: To switch between  and  in RF mode, use the buttons on the handpiece or footswitch.Note: In shaver mode, the console uses radio frequency identication () 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.
EN-31Using the HandpieceWarning During use, the RF 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 handpieces are intended for single use only and should not be reprocessed or reused.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.Each handpiece has its own set of controls.RF Hand Controls1231. Adjust CUT power level2. Activate CUT3. ActivateCOAG
EN-32Shaver Hand Controls123Default 1 Default 2 / NoneDefault 31. Oscillate (one-touch)Activate Oscillate (one-touch)2. Forward (one-touch)Select Mode:Oscillate or Forward /ReverseJog3. Reverse (one-touch)Forward/ReverseForward (one-touch)Using the Footswitche RF and shaver handpieces can also be controlled by the Crossre™ Footswitch. e default footswitch controls are shown below. To customize button assignments, contact your Stryker representative.Note: To keep the footswitch clean during use, Stryker recommends using disposable bags (P/N 0277-500-100). Contact your local Stryker representative for ordering information.
EN-33Default RF ControlsButton Function (controls are the same for defaults 1, 2, and 3)I Decrease Cut LevelII Select Handpiece:RF or ShaverIII Increase Cut LevelACutBCoag
EN-34Default Shaver ControlsButton 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) Oscillate/Reverse (variable)Oscillate/Reverse (xed)B Forward/Reverse (variable)Oscillate/Forward (variable)Oscillate/Forward (xed)Note: When using small-joint handpieces, only Default 2 settings are available. No other defaults or user preferences can be applied.
EN-35Using the iSWITCH™ Wireless Footswitche Crossre™ system can be used with the iSWITCH Wireless Footswitch System. 1. Connect the Crossre™ 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-36Audible Feedbacke Crossre™ Console will provide audible feedback for the following events: Event SignalDuring system startupSystem self-test Two-second beepHandpiece connected Single beepDisposable attachment connected Single beepFootswitch detected Single beepRF probe detected Single beepDuring useRFCOAGmodeactive Continuous tone (low)RF CUT mode active Continuous tone (high)System error ree beepsForce modulation on / o Single beepShaver reverse mode activated Five short beepsToggle (from footswitch) between RF and Shavere console will say, “Shaver” or “SERFAS”
EN-37TroubleshootingProblem 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.e 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 soware default is detected• Turnthepoweroffandonagain.• Iftheproblempersists,contactaStryker representative or return the console for repair.e 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.e 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.e 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.Hand-piecee temperature is higher than normal Allow the unit to cool before restarting.e unit has reached its recommended service interval Contact your Stryker representative.
EN-38DisposableAttachmentsRF 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 detected Disconnect the wired footswitch.e footswitch icon does not appear• Ensuretheunitisconnected.• Ensurethatthereisnodamagetothe cable or connector.Note: If a disturbance occurs on the video monitor, the user should ensure that the probe cable is not near any other instrument cables.
EN-39Cleaning 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™ 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.Maintenancee Crossre™ console requires no preventative or periodic maintenance. However, Stryker recommends you reboot the system daily for best performance.
EN-40Disposalis 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-41Technical SpecificationsStryker 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 SpecificationsOperating 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 SpecificationsMotor output max speed: 12000 RPMMotor duty cycle: Continuous operationRF output waveform: 200 kHz ± 1%, square wave, Crest factor <1.5 @ 200 ohms
EN-42ClassificationsWarning is 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-M90Generator 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.
EN-43Output Power versus Setting at 200ohms Resistive LoadOutput Power versus Setting at 200 Ohm Load050100150200250300350400Coag1Coag2Coag31234567 8910 11Cut LevelPower (W)Output Power (CUT) versus Load ResistanceOutput Power (Cut) versus Load Resistance0501001502002503003504000100 200 300 400 500 600 700 800 900 1000Load Resistance (ohms)(Power (W)Half Setting Full Setting
EN-44Output Power (COAG) versus Load ResistanceOutput Power (Coag) versus Load Resistance01020304050607080901000100 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 Setting050100150200250300350400Coag1Coag2Coag312345678910 11Cut LevelVoltage (Vrms)
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, France1000-401-036 Rev E 2009/05

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