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......
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.
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.
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.
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.
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 2 3 5 4 1.
Package Contents Carefully unpack the Crossfire 2 console and inspect each of the following components. Report any damaged components to Stryker.
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 1 CROSSFIRE II 2 3 8 9 4 INTEGRATED RESECTION AND SEALING SYSTEM 5 6 7 1.
Rear Panel The rear panel provides ports for connecting the console to other Stryker equipment. 1 2 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.
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 1 2 3 4 5 Control Description 1. Menu The Menu button opens a menu for selecting user and system settings. 2.
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.
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.
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.
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. 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. .
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.
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.
Default Handpiece Controls 1. Default 1 Default 2 / None Default 3 Oscillate (one touch) Activate / Deactivate Oscillate (one touch) 1 TOUCH 1 TOUCH 1 DRAFT 2 2. 3 Forward (one touch) 1 TOUCH 3. Reverse (one touch) 1 TOUCH Select Mode: Oscillate or Forward / Reverse Jog Forward/ Reverse Forward (one touch) 1 TOUCH Note: Default settings can be selected in the User Preference Settings screen on the console.
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.
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.
Reading the LCD In shaver mode, the LCD will show: 1 2 9000 VAR F DRAFT MC DISP NAME 3 1. Footswitch status 4 5 Crossfire Footswitch connected iSWITCH footswitch connected not connected 2.
System Feedback Event Audible Feedback Visible Feedback (via LCD) Reverse activated five high beeps R Forward activated/ resumed low beep F 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.
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.
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.
Reading the LCD In RF ablation mode, the LCD will show: 1 2 11 5 6 DRAFT 3 . . . HC SERFAS 4 1. Footswitch status 7 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.
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.
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 F DRAFT SERFAS FIXED F 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.
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.
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.
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.
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.
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.
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.
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.
Default Handpiece Controls 3 2 DRAFT 1 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).
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.
Reading the LCD In vessel sealing mode, the LCD will show: 1 2 3 SEAL 3 4 5 DRAFT HC VESSEL SEALER 6 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.
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: 1 2 1 DRAFT 3 1. Error Code 2.
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.
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.
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 2 1. Error Code 2.
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.
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.
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.
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 (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 0 0 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 0 Coag Coag Coag 1 2 3 1 2 3 4 5 6 7 8 9 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
