Stryker Crossfire 2 Manual
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Stryker Crossfire 2 Manual

Integrated resection and energy system
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Crossfire® 2
Integrated Resection and Energy System
0475-100-000

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Summary of Contents for Stryker Crossfire 2

  • Page 1 Crossfire® 2 Integrated Resection and Energy System 0475-100-000...

  • Page 3: Table Of Contents

    Indications ...........................7 Contraindications ........................7 Package Contents ........................7 Available Accessories .......................7 The Crossfire 2 Console ......................8 Setup and Device Connections ................11 Connecting to the iSWITCH Wireless Footswitch ............13 Operation ......................... 14 Powering the Console On and Off ................... 14 Adjusting User and System Settings ................

  • Page 5: Warnings And Cautions

    Use only conductive irrigants such as saline or Ringer’s lactate in order for the system to function properly. 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.
  • Page 6 Install this device in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices. 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.
  • Page 7 Do not activate the Crossfire 2 system until the probe is properly positioned in the patient. Ensure that the probe tip, including the return electrode, is completely surrounded by irrigant solution during use.

  • Page 8: Product Description/Intended Use

    Product Description/Intended Use The Crossfire 2 Integrated Resection and Energy System is a combination powered shaver system/ electrosurgical generator that powers arthroscopic shaver handpieces and RF surgical probes for use in a variety of arthroscopic and orthopedic surgeries. Illustrated below, the Crossfire 2 system consists of the following components: Crossfire 2 Console (featured in this manual)

  • Page 9: Indications

    Indications The Stryker Crossfire 2 System is intended for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The Crossfire 2 System provides abrasion, resection, debridement and removal of bone and soft tissue through its shaver blade;...

  • Page 10: The Crossfire 2 Console

    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, 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.
  • Page 11 Rear Panel The rear panel provides ports for connecting the console to other Stryker equipment. Firewire Enables connection to other Stryker Firewire devices, such Connectors as the iSWITCH Universal Wireless Footswitch USB Drive Enables software installation from authorized service personnel Equipotential —...
  • Page 12 Interface The Crossfire 2 interface displays system status, enables you to choose between RF ablation 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.

  • Page 13: Setup And Device Connections

    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.
  • Page 14 Connect the AC power. Connect the handpieces and footswitch. Note: The console will display an error message if expired or used attachments are connected: Connect suction tubing (for all suction- capable devices). EN-12...

  • Page 15: Connecting To The Iswitch Wireless Footswitch

    Connecting to the iSWITCH Wireless Footswitch The Crossfire 2 system can be used with the iSWITCH Wireless Footswitch System. Connect the Crossfire 2 console to the iSWITCH console using one of the Firewire connection ports on each console. Consult the iSWITCH Operating and Maintenance Manual (P/N 1000-400-700) for further operation instructions.

  • Page 16: Operation

    Operation 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. Note: Should emergency shutdown become necessary, power off the console as described above.

  • Page 17: Adjusting User And System 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.

  • Page 18: Arthroscopy Shaver Controls

    Stryker representative. 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.
  • Page 19 Default Footswitch Controls Function Button Default 1 Default 2 / None Default 3 Function Select Mode Option(s) — Oscillate or Forward/Reverse Function Select Handpiece Option(s) RF or Shaver Function Select Direction Select Speed Option(s) Forward or Reverse High or Low Function Oscillate Oscillate/Reverse...
  • Page 20 Reading the LCD In shaver mode, the LCD will show: 9000 MC DISP NAME Footswitch Crossfire footswitch is connected status iSWITCH footswitch is connected no footswitch is connected Footswitch One Touch TOUCH response (pressing the foot pedal once activates the shaver to a default speed;...

  • Page 21: Rf Ablation Controls

    RF Ablation Controls RF probes can be controlled by the buttons on the handpiece or by the pedals on the Crossfire Footswitch. The default controls for each are provided below. To customize button assignments, contact your Stryker representative. Warnings •...
  • Page 22 Default Footswitch Controls Function Button (Controls are the same for defaults 1, 2 and 3) Function Decrease Cut Level Function Select Handpiece Option(s) RF or Shaver Function Increase Cut Level Function Option(s) Function Coag Option(s) EN-20...
  • Page 23 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.
  • Page 24 Reading the LCD In RF ablation mode, the LCD will show: . . . SERFAS Mode cut mode activated coagulation mode activated Footswitch Status Crossfire Footswitch connected iSwitch footswitch connected not connected CUT Power power setting Hand Controls hand control is enabled hand control is disabled Disposable RF Probe Name (name)

  • Page 25: Dual Controls

    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 Selecting a mode will enable the selected handpiece to be controlled by the footswitch.
  • Page 26 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. • dual mode 9000 • shaver handpiece controlled by FIXED footswitch SERFAS...

  • Page 27: Troubleshooting

    A hardware fault • Turn the power off and on again. is detected • If the problem persists, contact a Stryker representative or return the console for repair. The AC voltage is • Turn the power off and on again.

  • Page 28: Error Codes

    Ensure that there is no damage to the cable or appear connector. 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: Error Code Category...

  • Page 29: Cleaning And Maintenance

    Cleaning and Maintenance Cleaning Warning To avoid electric shock and potentially fatal injury, unplug the Crossfire 2 console from the electrical outlet before cleaning. Caution • Do not spray cleaning liquid directly onto the unit as product damage may result.

  • Page 30: Disposal

    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. Follow hospital procedure to dispose of any contaminated disposable system accessories. The Batteries Directive 2006/66/EC introduces new requirements from September 2008 on removability of batteries from waste equipment in EU Member States.

  • Page 31: Technical Specifications

    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.

  • Page 32: Generator Output

    Generator Output Output power at each set point with specified load resistance (per IEC 60601-2-2, sub clause 6.8.3) is given in the graphs below. Output Power versus Setting at 200ohms Resistive Load Coag Coag Coag Cut Level Output Power (CUT) versus Load Resistance Half Setting Full Setting Load Resistance (Ohms)
  • Page 33 Output Power (COAG) versus Load Resistance Coag1 Coag2 Coag3 Load Resistance (Ohms) Maximum Open Circuit Voltage Versus Set Point Coag Coag Coag Cut Level N-31...

  • Page 34: Classifications

    (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note: FCC regulations provide that changes or modifications not expressly approved by Stryker Endoscopy could void your authority to operate this equipment.

  • Page 35: Radio Equipment Directive Compliance

    Radio Equipment Directive Compliance Hereby, Stryker Endoscopy declares that the radio equipment listed below is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.stryker.com/en-us/Divisions/Endoscopy/IFUs/index.htm. Search by the product number and refer to the resulting Declaration of Conformity for that product.

  • Page 36: Electromagnetic Compatibility

    Ensure all systems are installed according to the requirements of IEC 60601-1-1. 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.
  • Page 37 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...
  • Page 38 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.

  • Page 39: Symbols

    These symbols are defined below. Warning Warning Follow instructions for use Caution Dangerous voltage Front Console On / Off Select Down Menu Footswitch RF probe Shaver handpiece Type BF applied part Rear Console Equipotentiality Stryker firewire Emits RF radiation Equipotentiality Protective earth (ground) N-37...
  • Page 40 Compliant to CSA C22.2 Fuse rating No. 601.1-M90, and UL 601-1 Fulfills requirements of the Alternating current European Medical Device Directive 93/42/EEC This product contains electrical waste or electronic equipment. It Does not contain the must not be disposed of as hazardous substances listed in unsorted municipal waste China regulation SJ/T11364...
  • Page 41 Fragile Consult instructions for use...
  • Page 44 Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Crossfire, SERFAS, iSwitch, and the Stryker logo. All other trademarks are trademarks of their respective owners or holders. WCR: None...

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