Crossfire 2 Instructions for Use

Table of Contents Warnings and Cautions...3 Product Description/Intended Use...6 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... 15 Arthroscopy Shaver Controls... 16 RF Ablation Controls... 19 Dual Controls... 23 Troubleshooting... 25 Error Codes... 26 Cleaning and Maintenance... 27 Cleaning... 27 Maintenance... 27 Disposal... 28 Technical Specifications... 29 Generator Output... 30 Classifications... 32 Radio Equipment Directive Compliance... 33 Electromagnetic Compatibility... 34 Symbols... 37

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Warnings and Cautions Caution: Federal law (USA) restricts this device to use by, or on order of, a physician.

Operator Profile The Crossfire 2 system is intended for use only by licensed medical professionals, properly trained in the use of arthroscopic and 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.

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 Crossfire 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 effect, or product damage. 5. Do not use the Crossfire 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 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. 9. 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. 10. Do not obstruct the fans located near the rear and side of the console. Position the console so the fan directs the flow of air away from the patient. 11. Keep the activation indication lights and speaker in field of view and hearing at all times during activation. The light and sound are important safety features.

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Fire/Burn Warnings 1.

Do not use this device in the presence of flammable anaesthetics, gases, or fluids, such as skin prepping agents and tinctures. Observe appropriate fire precautions at all times.

2.

To prevent the risk of explosion, do not use this device in oxygen-enriched atmospheres, nitrous oxide (N₂O) atmospheres, or in the presence of other oxidizing agents. Ensure that

3.

oxygen connections in the surgical environment are not leaking. Electrosurgical components, such as the RF probe, may remain hot after activation. To avoid combustion, keep all electrosurgical equipment away from flammable materials.

4.

Do not use flammable agents for cleaning and disinfection of the Crossfire 2 console, handpiece, or footswitch.

5.

To prevent the risk of fire, do not replace console fuses. If it is suspected that fuses are damaged, return the console to Stryker for repair.

Electrical Safety Warnings 1. 2. 3.

4. 5. 6. 7.

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. When the Crossfire 2 system is activated, the conducted and radiated electrical fields may interfere with other electrical medical equipment. Provide as much possible distance between the console and other electronic medical equipment. Connect the power cord to a grounded receptacle. To prevent risk of electric shock, do not use extension cords or adapter plugs. Do not wrap the handpiece cable around metal objects, or the induction of hazardous currents may result. Keep the ends of the handpiece cable connectors, footswitch cable connectors, and console receptacles away from all fluids. 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.

Electrosurgery Warnings 1. 2. 3.

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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. Position the cables to avoid contact with the patient, electrodes, cables, and any other electrical leads that provide paths for high frequency current. 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.

4.

When the Crossfire 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. 6.

During use, operators should wear standard surgical gloves to help reduce the risk of electric shock. 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 Crossfire 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

10. 11. 12.

13. 14. 15.

irrigant solution during use. Maintain the active electrode in the field of view at all times to avoid tissue damage. Keep active electrodes isolated from the patient when not in use. 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. Failure of the system may result in an unintended increase in output power. Neuromuscular stimulation may occur when RF probes are used. 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 specified 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.

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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:

1

2

3

4

1.

Crossfire 2 Console (featured in this manual) • Acts as a connection hub for the various components of the Crossfire 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 Crossfire 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.

Crossfire Footswitch Provides remote, foot control of the powered shaver handpiece and RF probe

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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; 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 Crossfire 2 console and inspect each of the following components. • (1) Crossfire 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 Crossfire 2 system is compatible with the following accessories:

System Accessories 0475-000-100

Crossfire 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 firewire 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

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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. 1

5

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6

7

2

3

8

9

4

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 off

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 Crossfire Footswitch

Rear Panel The rear panel provides ports for connecting the console to other Stryker equipment. 1

2

3

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

-

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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.

1

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2

3

4

5

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 Crossfire 2 interface.

5.

Adjust

The Adjust buttons increase/decrease speed and power settings for the selected device.

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 inservice after your equipment has arrived.

•

• • •

•

•

1.

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 field. The Crossfire 2 System is compatible only with the Stryker handpieces and footswitches listed in this manual. Do not connect any equipment not specified 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 difficult to disconnect the AC power cord.

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 flow of air away from the patient. • Keep the activation indication lights and speaker in field of view and hearing at all times during activation. The light and sound are important safety features.

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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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Connecting to the iSWITCH Wireless Footswitch The Crossfire 2 system can be used with the iSWITCH Wireless Footswitch System. 1.

2.

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.

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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. As an added safety measure, the console can be separated from the AC power mains by detaching the AC power cord from either end.

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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. 1.

Press menu

.

2.

Press adjust

3.

Press select to confirm selection and exit. Or, press menu to cancel selection.

to select a default setting.

Note: User preference settings will not take effect unless a disposable attachment is connected to the shaver.

System Settings System settings, such as screen brightness, contrast, and system sound can be adjusted through the Crossfire 2 interface. 1.

Press and hold menu . Note: If an RF probe is connected to the console, the COAG adjustment screen will appear. Press menu again to access the system settings screen.

2.

Press select to choose: • contrast, brightness, or • • sound. The arrow will indicate your selection.

3.

Press adjust

4.

Press select to confirm selection and exit. Or, press menu to cancel your selection.

to select a default setting.

Note: A short press will display the current version of the console software.

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Arthroscopy Shaver Controls Arthroscopy shaver handpieces 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.

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. Improper connection may cause arcing or malfunction of the handpiece or console, which can result in injury, unintended surgical effect, or product damage. During use, operators should wear standard surgical gloves to help reduce the risk of electric shock. 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. 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.

•

•

• •

•

Default Handpiece Controls 1

2

3

Note: Default settings can be selected in the User Preference Settings screen on the console. Settings will not take effect until a disposable attachment is connected to the shaver handpiece. Function

Button

I II III

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Default 1

Default 2 / None Activate / Deactivate

Default 3

Function

Oscillate

Option(s)

1 TOUCH

Function

Forward

Select Mode

Jog

Option(s)

1 TOUCH

Oscillate or Forward /Reverse

-

Function

Reverse

Forward/Reverse

Forward

Option(s)

1 TOUCH

-

1 TOUCH

1 TOUCH

One Touch

One Touch

One Touch

Oscillate One Touch

One Touch

Default Footswitch Controls

Function Button

Default 1

Default 2 / None

Default 3

I

Function

Jog

Select Mode

Option(s)

-

Oscillate or Forward/Reverse

II

Function

Select Handpiece

Option(s)

RF or Shaver

III

Function

Select Direction

Select Speed

Option(s)

Forward or Reverse

High or Low

Function

Oscillate

Oscillate/Reverse

Option(s)

FIXED

Function

Forward/Reverse

A B

Option(s)

VAR

fixed

variable

VAR

variable

FIXED

fixed

FIXED

fixed

Oscillate/Forward VAR

variable

Note: When using small-joint handpieces, only Default 2 settings are available. No other defaults or user preferences can be applied.

Console Controls Adjusting Cutting Speed Use the adjust buttons on the console to manually adjust the power or speed setting for the active handpiece. Notes: • In shaver mode, the console uses radio frequency identification (rfid) 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. • Forward and reverse settings are adjusted independent of each other. Adjusting settings in one mode will not affect the other.

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Reading the LCD In shaver mode, the LCD will show: 1

2

9000

VAR

F 3

1.

Footswitch status

4

MC DISP NAME

5

Crossfire footswitch is connected iSWITCH footswitch is connected no footswitch is connected

2.

Footswitch response

1 TOUCH

FIXED

VAR

One Touch (pressing the foot pedal once activates the shaver to a default speed; pressing the foot pedal again stops the shaver) Fixed (pressing the foot pedal at any pressure results in a constant speed) Variable (shaver speed varies, depending on the pressure applied to the foot pedal) Mix (oscillate speed is fixed; forward/reverse speed is variable)

3.

Direction

F

Forward

R

Reverse Oscillate

4.

Cutter Name

(name)

5.

Speed

(#)

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rotations per minute

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

Speed indicator number increases or decreases

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 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.

Default Handpiece Controls 1

1.

2. 3.

2

3

Adjust CUT power level (single press) or Activate/deactivate Force Modulation (press and hold for three seconds) Activate CUT Activate COAG

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Default Footswitch Controls

Button

Function (Controls are the same for defaults 1, 2 and 3)

I

Function

Decrease Cut Level

II

Function

Select Handpiece

Option(s)

RF or Shaver

III

Function

Increase Cut Level

A

Function

B

Function

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Option(s) Option(s)

Cut Coag