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Crossfire 2
User Manual
66 pgs2.09 Mb0
User Manual
762 pgs23.18 Mb0
User Manual
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Stryker Crossfire 2 User Manual

Crossre® 2
Integrated Resection and Energy System
0475-100-000
EN-1
Table of Contents
Warnings and Cautions ............................................................................................3
Product Description/Intended Use ........................................................................6
Connecting to the iSWITCH Wireless Footswitch ........................................................13
Powering the Console On and O ...................................................................................14
Adjusting User and System Settings ...............................................................................15
Arthroscopy Shaver Controls .............................................................................................16
RF Ablation Controls .............................................................................................................19
Dual Controls ...........................................................................................................................23
Error Codes ...............................................................................................................................26
Cleaning .....................................................................................................................................27
Maintenance ............................................................................................................................ 27
Disposal......................................................................................................................................28
Generator Output ...................................................................................................................30
Classications ..........................................................................................................................32
Radio Equipment Directive Compliance ........................................................................33
Electromagnetic Compatibility ......................................................................................... 34
EN-3
Warnings and Cautions
Caution: Federal law (USA) restricts this device to use by, or on order of, a physician.
Operator Prole
The Crossre2 system is intended for use only by licensed medical professionals, properly trained in the use of arthroscopic and electrosurgical equipment and techniques. The Crossre2 system generates potentially hazardous levels of energy that can result in injury or even death if improperly used.
General Warnings
To avoid potential serious injury to the user and the patient, observe the following warnings:
1. Read this manual thoroughly and be familiar with its contents prior to operating the equipment.
2. Carefully unpack the device and ensure that all components are accounted for and remain undamaged from shipment.
3. Inspect all handpieces and probes for damage to the cable insulation. If damage is found, refer to the Stryker Standard Warranty and Return Policy (1000-401-175).
4. Before using the Crossre2 system in an actual procedure, verify that each component is installed and functioning properly. Improper connection may cause arcing or malfunction of the handpiece or console, which can result in injury, unintended surgical eect, or product damage.
5. Do not use the Crossre2 system on patients with cardiac pacemakers or other electronic device implants. Doing so could lead to electromagnetic interference and possible death.
6. 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.
7. 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.
8. Do not use the Crossre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.
9. Do not activate the Crossre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.
10. Do not obstruct the fans located near the rear and side of the console. Position the console so the fan directs the ow of air away from the patient.
11. Keep the activation indication lights and speaker in eld of view and hearing at all times during activation. The light and sound are important safety features.
EN-4
Fire/Burn Warnings
1. Do not use this device in the presence of ammable anaesthetics, gases, or uids, such as skin prepping agents and tinctures. Observe appropriate re precautions at all times.
2. To prevent the risk of explosion, do not use this device in oxygen-enriched atmospheres, nitrous oxide (NO) atmospheres, or in the presence of other oxidizing agents. Ensure that oxygen connections in the surgical environment are not leaking.
3. Electrosurgical components, such as the RF probe, may remain hot after activation. To avoid combustion, keep all electrosurgical equipment away from ammable materials.
4. Do not use ammable agents for cleaning and disinfection of the Crossre2 console, handpiece, or footswitch.
5. To prevent the risk of re, do not replace console fuses. If it is suspected that fuses are damaged, return the console to Stryker for repair.
Electrical Safety Warnings
1. Install this device in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices.
2. Crossre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.
3. When the Crossre2 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.
4. Connect the power cord to a grounded receptacle. To prevent risk of electric shock, do not use extension cords or adapter plugs.
5. Do not wrap the handpiece cable around metal objects, or the induction of hazardous currents may result.
6. Keep the ends of the handpiece cable connectors, footswitch cable connectors, and console receptacles away from all uids.
7. 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.
Electrosurgery Warnings
1. Inspect electrosurgical accessories for defects prior to use. Do not use any cable or electrode that is cut, broken, or otherwise damaged, as burns or electric shock may result.
2. Position the cables to avoid contact with the patient, electrodes, cables, and any other electrical leads that provide paths for high frequency current.
3. To prevent the risk of shock, 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. The use of antistatic sheeting is recommended for this purpose.
EN-5
4. When the Crossre2 system and physiological monitoring equipment are used simultaneously on a patient, position any monitoring electrodes as far as possible from the surgical electrodes. Monitoring equipment using high frequency, current-limiting devices is recommended. Needle monitoring electrodes are not recommended.
5. During use, operators should wear standard surgical gloves to help reduce the risk of electric shock.
6. To prevent patient injury, select the lowest output power required for the intended purpose.
7. Do not exceed the rated accessory voltage of electrosurgical accessories. Only use electrosurgical accessories that have a rated accessory voltage equal to or greater than the maximum output voltage of the generator.
8. Do not activate the Crossre2 system until the probe is properly positioned in the patient.
9. Ensure that the probe tip, including the return electrode, is completely surrounded by irrigant solution during use.
10. Maintain the active electrode in the eld of view at all times to avoid tissue damage.
11. Keep active electrodes isolated from the patient when not in use.
12. When not in use, remove the handpiece and disposable attachments from the surgical site and place them away from metallic objects. 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.
13. Failure of the system may result in an unintended increase in output power.
14. Neuromuscular stimulation may occur when RF probes are used.
15. Smoke generated during electrosurgical procedures may be harmful to surgical personnel. Take appropriate precautions by wearing surgical masks or other means of protection.
Cautions
To avoid product damage, observe the following cautions.
1. While using the handpiece, do not touch the attachment to metal objects, such as an endoscope or metal cannula. Damage to the attachments or other devices may result.
2. Attempt no internal repairs or adjustments, unless specied otherwise in this manual. Units requiring repair should be returned to Stryker.
3. Pay close attention to the care and cleaning instructions in this manual. Failure to follow these instructions may result in product damage.
4. Do not remove the cover of the console as this could cause electric shock and product damage.
EN-6
Product Description/Intended Use
The Crossre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 Crossre2 system consists of the following components:
1
2
3
4
1. Crossre2 Console (featured in this manual)
• Acts as a connection hub for the various components of the Crossre2 system
• Powers a motorized shaver handpiece for the mechanical cutting and debridement of
bone and soft tissue
• Generates bipolar radio frequency (RF) energy for electrosurgical cutting and
coagulation of tissue
• Provides a central user interface for operating the Crossre2 system
2. Powered Shaver Handpiece (and disposable attachments)
• Enables arthroscopic cutting and debridement
• Type BF applied part
3. Disposable RF Probe
• Enables RF cutting and coagulation
• Type BF applied part
4. Crossre Footswitch Provides remote, foot control of the powered shaver handpiece and RF probe
EN-7
Indications
The Stryker Crossre 2 System is intended for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The Crossre 2 System provides abrasion, resection, debridement and removal of bone and soft tissue through its shaver blade; and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.
Contraindications
The electrosurgical probe should not be used in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.
Package Contents
Carefully unpack the Crossre2 console and inspect each of the following components.
• (1) Crossre 2 Console
• (1) Hospital-grade power cord
• (1) User Guide
If damage is found, refer to the Stryker Standard Warranty and Return Policy (1000-401-175).
Available Accessories
The Crossre 2 system is compatible with the following accessories:
System Accessories
0475-000-100 Crossre Footswitch
0277-200-100 iSWITCH Universal Wireless Footswitch Receiver
0277-200-101 iSWITCH Universal Wireless Footswitch Receiver (AUS)
0277-100-100 iSWITCH Universal Wireless Footswitch
6000-001-020 Stryker rewire cable
Arthroscopy Accessories
0279-xxx-xxx SERFAS Energy family of electrosurgical probes
0375-708-500 Formula 180 Handpiece
0375-704-500 Formula Handpiece (with buttons)
0375-701-500 Formula Handpiece (without buttons)
0275-601-500 Small-Joint Shaver Handpiece
EN-8
The Crossre 2 Console
The Crossre2 console is the connection hub for the components of the Crossre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.
5
7 8
9
3
1 4
6
2
1. Menu Selects menu items
2. Select Selects which device displays on the LCD screen.
3. RF connector (SERFAS Energy)
Delivers RF energy for ablation handpieces
4. Handpiece connector Powers shaver handpieces
5. 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 feedback
8. Adjust Adjusts options for connected devices
9. Footswitch connector Connects to the Crossre Footswitch
EN-9
Rear Panel
The rear panel provides ports for connecting the console to other Stryker equipment.
321 4
1. Firewire Connectors
Enables connection to other Stryker Firewire devices, such as the iSWITCH Universal Wireless Footswitch
2. USB Drive Enables software installation from authorized service
personnel
3. Equipotential Ground Plug
—
4. AC Power Inlet —
EN-10
Interface
The Crossre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 Crossre Footswitch.
1 2 3 54
1. Menu The Menu button opens a menu for selecting user and system settings.
2. Error indicator The Error indicator shines red when a system error occurs.
3. LCD screen The LCD screen displays system status, error codes, mode of operation, cutting speed, and power levels.
4. Select The Select button toggles between RF and Shaver controls. The selected device can then be controlled using the Crossre2 interface.
5. Adjust The Adjust buttons increase/decrease speed and power settings for the selected device.
EN-11
Setup and Device Connections
Stryker Endoscopy considers instructional training an integral part of the Crossre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 sta on its operation and maintenance. Please contact your local Stryker Endoscopy representative to schedule an in­service after your equipment has arrived.
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.
• Only the handpieces and disposable attachments are suitable for use in the patient environment. The console and footswitch are not sterile devices and should not enter the sterile eld.
• The Crossre2 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.
• The separable AC power cord is provided as a means of emergency shutdown and disconnection from the power source. Do not position the console in a way that is dicult to disconnect the AC power cord.
1. Place the console on a sturdy platform, such as a Stryker cart.
• Select a location according to the recommendations in the “Electromagnetic Compatibility” section of this user guide.
• Leave four inches of space around all sides for convection cooling.
• Do not obstruct the fans located near the rear and side of the console. Position the
console so the fan directs the ow of air away from the patient.
• Keep the activation indication lights and speaker in eld of view and hearing at all times during activation. The light and sound are important safety features.
EN-12
2. Connect the AC power.
3. Connect the handpieces and footswitch.
Note: The console will display an error message if expired or used attachments are connected:
4. Connect suction tubing (for all suction­capable devices).
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