Stryker Endoscopy 5900 Optical Court, San Jose, CA 95138 APPROVALS DRAWN BY: A LTR A B C D E F G H J K L M N P R T U V W Y TITLE Crossfire Console User Guide (English) 05/15/09 A. Infanger ORIGINATOR C. Bennett SIZE REV. DATE 05/19/09 DOCUMENT NO. E ECN NO. ECO116602 45458 45524 ECO30971 ECO31369 1000-401-036 REVISIONS DATE 02/17/09 03/05/09 03/12/09 04/22/09 05/19/09 APPROVED R. Cardenas R. Cardenas C. Bennett C. Bennett C. Bennett LTR ECN NO.
Crossfire™ Console REF 0475000000 User Guide
Contents Warnings and Cautions. .............................................................5 Symbol Glossary.............................................................................9 Product Description and Intended Use. .........................11 Indications/Contraindications...........................................................12 Package Contents............................................................................12 Available Accessories..................................................
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 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.
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.
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. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. DO NOT use the Crossfire™ 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.
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. EN-8 DO NOT attempt to reuse or resterilize any product labeled “SingleUse,” 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™ console, handpiece, or footswitch.
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.
Fuse rating Compliant to CSA C22.2 No. 601.
Product Description and Intended Use The Crossfire™ Integrated Arthroscopy System is a combination powered shaver system/electrosurgical generator, intended for use in arthroscopic and orthopedic procedures. Illustrated below, the Crossfire™ system consists of the following components: 1 2 3 4 1.
Indications/Contraindications The Crossfire™ system is indicated for use in orthopedic and arthroscopic procedures for the 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.
The Crossfire™ Console The Crossfire™ console is the connection hub for the components of the Crossfire™ system. It generates RF energy, 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. 1 5 6 7 2 3 8 9 4 1. Menu Selects menu items 2. Select Selects which device displays on the LCD screen. 3.
Rear Panel The rear panel provides ports for connecting the console to other Stryker equipment. 9 10 11 9. Firewire Connectors Enables connection to other Stryker Firewire devices, such as the iSWITCH Universal Wireless Footswitch 10. USB Drive Enables uploading of preset user settings 11. Equipotential Ground Plug — 12.
Setup and Interconnection Stryker Endoscopy considers instructional training an integral part of the Crossfire™ 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.
If the Crossfire™ System is used adjacent to or stacked with other equipment, observe and verify normal operation of the Crossfire™ 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™ System. When the Crossfire™ System is interconnected with other medical electrical equipment, leakage currents may be additive.
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The Crossfire™ System is intended for use in the electromagnetic environment specified below. The customer or the user of Crossfire™ 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™ System is intended for use in the electromagnetic environment specified below. The customer or the user of Crossfire™ System should ensure that it is used in such an environment.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Crossfire™ System The Crossfire™ System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Connections Warning Be sure that no liquid is present between connections to the console and the handpiece. Connection of wet accessories may lead to electric shock or electrical short. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Use only hospital-grade power cables. Using other cables may result in increased RF emissions or decreased immunity from such emissions.
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. 2. Connect the AC power. 3. Connect the handpieces and footswitch. 4. Connect suction tubing (for all suction-capable devices).
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-22 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.
Operation The Crossfire™ 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 Crossfire™ Footswitch. Warning The Crossfire™ system is intended for use only by licensed medical professionals, properly trained in the use of electrosurgical equipment and techniques.
The Crossfire™ Interface 1 2 3 4 Control Description See 1. Menu The Menu button sets user and system settings. “Adjusting User and System Settings” 2. LCD screen The LCD screen displays system status, error codes, mode of operation, cutting speed, and power levels. “Reading the LCD Screen” 3. Select The Select button toggles between RF and Shaver controls. The selected device can then be controlled using the Crossfire™ interface. “Selecting Between RF and Shaver Modes” 4.
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™ 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. .
System Settings System settings, such as screen brightness, contrast, and system sound can be adjusted through the Crossfire™ interface. 1. Press and hold 2. Press . to choose (contrast), (brightness), or (sound). 3. Press 4. Press and hold to adjust. to exit. (Note: A short press will display the current version of the console software.
Reading the LCD Screen The LCD screen displays the devices that are connected to the console and their current status. RF Mode In RF mode, the LCD will show: 1 2 3 11 SERFAS 4 1. Footswitch status 5 Crossfire footswitch connected iSwitch footswitch connected not connected 2. Mode cut mode coagulation mode 3. Force modulation force modulation activated force modulation not activated 4. Probe name (name) 5.
Shaver Mode In shaver mode, the LCD will show: 1 2 9000 VAR F MC DISP NAME 3 4 1. Footswitch status 5 Crossfire footswitch connected iSWITCH footswitch connected not connected 2. Button response 1 TOUCH FIXED VAR 3.
Dual Mode In dual mode, the LCD will show the status of both devices. The shaver status will always appear to the right, except during adjustments to RF settings. To select between RF and shaver modes, press 11 SERFAS FIXED F FIXED F 9000 . Dual mode, normal screen. MC DISP NAME 9000 11 MC DISP NAME SERFAS Dual mode, adjustments being made to RF power settings The screen will revert to normal after 5 seconds of inactivity.
Selecting Between RF and Shaver Modes To select the appropriate mode, do one of the following: • • • Press on the Crossfire interface. The interface will toggle between modes. Press the mode button on the footswitch. Press any button on the desired handpiece. Adjusting Power and Speed Settings Use 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.
Using the Handpiece Warning During use, the RF 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 handpieces are intended for single use only and should not be reprocessed or reused.
Shaver Hand Controls Default 1 Default 2 / None Default 3 1. Oscillate (one‑touch) Activate Oscillate (one-touch) 2. Forward (one‑touch) Select Mode: Oscillate or Forward /Reverse Jog 3. Reverse (one‑touch) Forward/ Reverse Forward (one‑touch) 1 2 3 Using the Footswitch The RF and shaver handpieces can also be controlled by the Crossfire™ Footswitch. The default footswitch controls are shown below. To customize button assignments, contact your Stryker representative.
Default RF Controls Button Function (controls are the same for defaults 1, 2, and 3) I Decrease Cut Level II Select Handpiece: RF or Shaver III Increase Cut Level A Cut B Coag EN-33
Default Shaver Controls Button Function Default 1 Default 2 / None Default 3 I 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 A Oscillate (fixed) Oscillate/Reverse (variable) Oscillate/Reverse (fixed) B Forward/Reverse (variable) Oscillate/Forward (variable)
Using the iSWITCH™ Wireless Footswitch The Crossfire™ system can be used with the iSWITCH Wireless Footswitch System. 1. Connect the Crossfire™ 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.
Audible Feedback The Crossfire™ Console will provide audible feedback for the following events: Event Signal During system startup System self-test Two-second beep Handpiece connected Single beep Disposable attachment connected Single beep Footswitch detected Single beep RF probe detected Single beep During use RF COAG mode active Continuous tone (low) RF CUT mode active Continuous tone (high) System error Three beeps Force modulation on / off Single beep Shaver reverse mode activated
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. 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 default is detected • • Turn the power off and on again.
Disposable Attachments 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 • • 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.
Cleaning and Maintenance Cleaning Console 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™ 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.
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. Dimensions Size: Weight: 16.9" L × 12.5" H × 4.
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.
Output Power versus at 200Resistive Ohm Load Load Output Power versus Setting at Setting 200ohms 400 350 Power (W) 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 Output Power (CUT) versus Load Resistance Output Power (Cut) versus Load Resistance 400 350 (Power (W) 300 Half Setting 250 Full Setting 200 150 100 50 0 0 100 200 300 400 500 600 700 800 900 1000 Load Resistance (ohms) EN-43
Power (Coag)Load versus Load Resistance Output Power Output (COAG) versus Resistance 100 90 Power (W) 80 70 Coag 1 60 Coag 2 Coag 3 50 40 30 20 10 0 0 100 200 300 400 500 600 700 800 900 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 Cut Level EN-44 6 7 8 9 10 11
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.
