Crossfire® 2

Integrated Resection and Energy System

0475-100-000

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 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
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 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. Install this device in an operating room that complies with all applicable IEC, CEC, and NEC
requirements for safety of electrical devices.
2. 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.
3. 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.
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 fluids.
7. 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. 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.

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 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. 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 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
irrigant solution during use.
10. Maintain the active electrode in the field 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 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

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 2 3 4

5 6 7 8 9

1. Menu Selects menu items

2. Select Selects which device displays on the LCD screen.

3. RF connector Delivers RF energy for ablation handpieces

(SERFAS Energy)
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

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

1 2 3 4

1. Firewire Enables connection to other Stryker Firewire devices, such

Connectors 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 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.

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 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.

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.

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 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 suction-

capable 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. 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 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   to select a default setting.

3. Press select   to confirm selection and exit.

Or, press menu to cancel selection.
 

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  to select a default setting.

4. Press select    to confirm selection and exit.

Or, press menu   to cancel your selection.

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 Default 1 Default 2 / None Default 3
Function Oscillate Activate / Deactivate Oscillate
I Option(s)
1
TOUCH
1
TOUCH
One Touch One Touch
Function Forward Select Mode Jog
II Option(s)
1
TOUCH
Oscillate or
—
One Touch Forward /Reverse
Function Reverse Forward/Reverse Forward
III Option(s)
1
TOUCH —
1
TOUCH
One Touch One Touch

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 Default Footswitch Controls

Function
Button Default 1 Default 2 / None Default 3
Function Jog Select Mode
I Option(s) — Oscillate or Forward/Reverse
Function Select Handpiece
II Option(s) RF or Shaver
Function Select Direction Select Speed
III Option(s) Forward or Reverse High or Low
Function Oscillate Oscillate/Reverse
A Option(s) FIXED
fixed
VAR
variable FIXED
fixed
Function Forward/Reverse Oscillate/Forward
B Option(s) VAR
variable VAR
variable FIXED
fixed

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
MC DISP NAME
3 4 5

1. Footswitch
Crossfire footswitch is connected
status
iSWITCH footswitch is connected

no footswitch is connected
2. Footswitch 1 One Touch
TOUCH
response (pressing the foot pedal once activates the shaver to a default
speed; pressing the foot pedal again stops the shaver)
Fixed
FIXED
(pressing the foot pedal at any pressure results in a constant
speed)

VAR
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 (#) rotations per minute

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 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 one beep for each unit of Speed indicator number
settings change 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 2 3

1. Adjust CUT power level (single press)

or
Activate/deactivate Force Modulation (press and hold for three seconds)
2. Activate CUT
3. Activate COAG

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 Default Footswitch Controls

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

I Function Decrease Cut Level

Function Select Handpiece

II Option(s) RF or Shaver

III Function Increase Cut Level

Function
A Option(s)
Cut

Function
B Option(s)
Coag

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 Console Controls

Adjusting CUT Power

• Press the adjust  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

COAG1
1. Press and hold menu . The COAG POWER LEVEL COAG2
screen will appear. COAG3
COAG POWER LEVEL
2. Press adjust  to adjust.

3. Press select to confirm selection and exit.

Note: COAG power can only be adjusted when an RF probe

is connected to the console.

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.
Currently, Force Modulation is an option only with the following SERFAS Energy probes: 90-S, 90-S
Max, and Super 90-S.
• To activate Force Modulation, hold down the grey power button on the SERFAS probe for
three seconds. A hammer icon will appear on the LCD screen of the console, indicating
Force Modulation activated.
• To deactivate Force Modulation, hold down the grey power button on the SERFAS probe for
three seconds. The hammer icon will disappear from the LCD screen.

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 Reading the LCD
In RF ablation mode, the LCD will show:

1 2 3

11
. . . HC
SERFAS
7 6 5 4

1. Mode
cut mode activated

coagulation mode activated

2. Footswitch Status
Crossfire Footswitch connected

iSwitch footswitch connected

not connected
3. CUT Power (#) power setting

4. Hand Controls
hand control is enabled

hand control is disabled

5. Disposable RF Probe Name (name)

6. COAG Power
low

medium

high

7. Force Modulation
force modulation activated

force modulation not activated

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 System Feedback

Event Audible Feedback Visible Feedback (via LCD)

CUT activated high, steady tone

COAG activated low, steady tone

Force modulation Single beep

on / off
System error Ten short beeps

Adjustments made to power one beep for each unit of CUT power indicator number
settings change increases or decreases

Change footswitch to control “SERFAS” “SERFAS” appears

RF mode
Change footswitch to control “Shaver” name of the disposable
Shaver mode attachment appears

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. To select
the appropriate mode, do one of the following:

• Press select    on the Crossfire 2 interface. The interface will toggle between modes.
The device controlled by the footswitch will appear on the right side of the LCD and will be
identified by the footswitch    icon.
• Press the toggle button (II) on the footswitch.
Note: Either handpiece can be activated at any time by pressing the button on the
handpiece.

Activating a Handpiece
To activate a handpiece in dual mode, do one of the following:
• Press any button on the desired handpiece.
• Press the footswitch pedal for the active handpiece.
Note: The active is identified by handpiece appears on the right side of the LCD.)

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 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

11 9000
• shaver handpiece controlled by FIXED

F
footswitch

SERFAS MC DISP NAME

• dual mode

9000 11
• RF probe controlled by FIXED

F
footswitch

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. Press select to move the desired handpiece to the right side of the LCD.

2. Use the adjust buttons on the console to manually adjust the power or speed
setting for the selected handpiece.

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.

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 one beep for each unit of Speed indicator number
settings change increases or decreases

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 Troubleshooting
Problem Solution
Console 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.
incorrect • If the problem persists, contact a Stryker
representative or return the console for repair.
A software 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 system does • Check the power cord to ensure it is properly
not power on connected.
• Check to ensure the cord is connected to a
grounded outlet.
The electrical • Power down all electrical equipment not in use.
interference is • Increase distance of other electrical equipment.
sporadic • Connect the unit and other equipment into different
outlets.
The generator • Ensure that there is proper airflow around the unit.
temperature is
too high
A power-on self • Turn the power off and on again.
test error has • If the problem persists, contact a Stryker
occurred representative or return the console for repair.
Handpiece The temperature • Allow the unit to cool before restarting.
is higher than
normal
The unit has • Contact your Stryker representative.
reached its
recommended
service interval
Disposable RF probe is not • Check the connection to the console.
Attachments ready
RF probe is • Replace probe.
expired
RF probe • Replace probe.
identification is
invalid
RF probe • Check the connection to the console.
communication • If necessary, replace probe.
error

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 Disposable Exceeded time • Replace probe
Attachment usage
(Continued) RF power is too • Check the probe for damage.
high • If necessary, replace probe.
RF voltage is too • Check the probe for damage.
high • If necessary, replace probe.
RF current is too • Check the probe for damage.
high • If necessary, replace probe.
RF delivery • Clear error and continue
has exceeded
continuous limit
Low impedance • Check the probe for damage.
detected • If necessary, replace probe.
Footswitch A wireless • Disconnect the wired footswitch.
footswitch is not
detected
The footswitch • Ensure the unit is connected.
icon does not • 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 Solution

A## Activation Errors Reactivate
E## System-level Errors Reboot system
P## Probe Errors Follow instructions on LCD, or replace disposable
attachment
W## Warning Errors No action required;
informational only
RF probe Check the connection to the console.
communication error If necessary, replace probe.

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 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.
Spray on the cloth before wiping the unit.
• Do not immerse the console in any liquid as product damage will result.
• Do not use corrosive cleaning solutions to clean the unit as product damage may
result.
• Do not sterilize the unit as product damage may result.

Console
Should the unit need cleaning:
1. Spray cleaning liquid onto a dry, sterile cloth. Avoid excess liquid or drips.
2. Wipe the unit.
3. Take extra care when cleaning the front LCD screen. Excess liquid or drips that enter the
bottom of the screen may result in product damage.

Footswitch
Consult the footswitch user guide for cleaning and reprocessing instructions.

RF Handpiece
RF handpieces are intended for single use only and should not be cleaned, sterilized, or reused.

Shaver Handpiece
Consult the appropriate user guide for cleaning and reprocessing instructions.
Disposable attachments are intended for single use only and should not be cleaned, sterilized, or
reused.

Maintenance
The Crossfire 2 console requires no preventative or periodic maintenance. However, Stryker
recommends you reboot the system daily for best performance.

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 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. To
comply with this Directive, this device has been designed for safe removal of the
batteries at end-of-life by a waste treatment facility. Infected units should be decontaminated
before they are sent for recycling. In the case that it is not possible to decontaminate the unit
for recycling, the hospital should not attempt to remove the batteries from waste equipment.
Continued disposal of small amounts of portable batteries to landfill and incineration is allowed
under the Batteries Directive 2006/66/EC and Member State regulations.

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 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: 16.9” L × 12.5” H × 4.5” W
Weight: 20 lbs

Environmental Specifications
Operating temperature: 5 – 40°C
Operating humidity: 30 – 95% RH
Shipping temperature: -18 – 60°C
Shipping humidity: 15 – 90% RH

System Input Power Requirements

Input: 100-240 VAC, 50/60 Hz, 6 – 10 A
Output: 400 W @ 200 ohms, 200 KHz
Inlet Fuse: 16AH, 250V

Electrical Specifications
Motor output max speed: 12000 RPM
Motor duty cycle: Continuous operation
RF output waveform: 200 kHz ± 1%, square wave,
Crest factor <1.5 @ 200 ohms

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 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

400
350
300
250
Power (W)

200
150
100
50
0
Coag Coag Coag 1 2 3 4 5 6 7 8 9 10 11
1 2 3

Cut Level

Output Power (CUT) versus Load Resistance

400
350
300
250
Power (W)

200
150 Half Setting
Full Setting
100
50
0
125
200
275
350
425
500
575
650
725
800
875
950
0
57

Load Resistance (Ohms)

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 Output Power (COAG) versus Load Resistance

140

120

100
Power (W)

80
Coag1
60
Coag2
40 Coag3

20

0
125
175
225
275
325
375
425
475
525
575
625
675
725
775
825
875
925
975
0
50
75

Load Resistance (Ohms)

Maximum Open Circuit Voltage Versus Set Point

400
350
300
Voltage (Vrms)

250
200
150
100
50
0
Coag Coag Coag 1 2 3 4 5 6 7 8 9 10 11
1 2 3

Cut Level

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 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 Medical Electrical Equipment

Type BF applied part
Degree of protection against harmful ingress of water: IPX0

Federal Communications Commission (FCC)

FCC ID: SSH-XFC2
Trade Name: Crossfire 2 Console
Type or Model: 0475100000
This device complies with Part 15 of the FCC rules. Operation is subject to the following two
conditions:
(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.
Frequency of transmission: 13.56MHz
Type of frequency / characteristics of the modulation: 10% ASK
Subcarrier: 423.75kHz, Manchester coding
Effective radiated power: 50μW

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.
The term “IC” before the radio certification number only signifies that Industry Canada technical
specifications were met.

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 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.

Type or Model: 0475100000

Product Name: Crossfire 2 Console

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 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.

Warnings

• This equipment is intended for use by health care professionals only. This equipment
may cause radio interference or may disrupt the operation of nearby equipment. It
may be necessary to take mitigation measures, such as reorienting or relocating the
equipment or shielding the location.
• Portable and mobile RF communications equipment can affect the normal function
of the Crossfire 2 System even if such equipment meets the applicable emissions
requirements.
• Do not use cables or accessories other than those provided with the Crossfire 2
System, as this may result in increased electromagnetic emissions or decreased
immunity to such emissions.
• If the Crossfire 2 System is used adjacent to or stacked with other equipment, observe
and verify normal operation of the Crossfire 2 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 2 System.
• 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. 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.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions CISPR11 Group 1 The Crossfire 2 System must emit electromagnetic

energy in order to perform its intended function. Nearby
electronic equipment may be affected.

RF emissions CISPR11 Class A Crossfire 2 System is suitable for use in all establishments
other than domestic and those directly connected to the
Harmonic emissions IEC 61000-3-2 Class A public low-voltage power supply network that supplies
buildings used for domestic purposes.
Voltage Fluctuations/flicker Complies
emissions IEC 61000-3-3

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 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) ±6kV contact ±6kV contact ±8kV air Floors should be wood,
IEC61000-4-2 ±8kV air concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.

Electrical fast transient/burst ±2kV for power ±2kV for power supply lines Mains power quality
IEC61000-4-4 supply lines should be that of a typical
commercial or hospital
±1kV for input/ ±1kV for input/output lines environment
output lines

Surge IEC61000-4-5 ±1kV differential ±1kV differential mode Mains power quality
mode should be that of a typical
commercial or hospital
±2kV common mode ±2kV common mode environment

Voltage dips, short <5% Ut (>95% dip in <5% Ut (>95% dip in Ut) for 0.5 cycle Mains power quality
interruptions and voltage Ut) for 0.5 cycle should be that of a
variations on power supply typical commercial or
input lines IEC61000-4-11 40% Ut (60% dip in 40% Ut (60% dip in Ut) for 5 cycles hospital environment.
Ut) for 5 cycles If the user of Crossfire
2 requires continued
70% Ut (30% dip in 70% Ut (30% dip in Ut) for 25 cycles operation during power
Ut) for 25 cycles mains interruptions, it
is recommended that
<5% Ut (>95% dip in <5% Ut (>95% dip in Ut) for 5 sec Crossfire 2 be powered
Ut) for 5 sec from an uninterruptible
power supply or a battery.

Power frequency (50/60Hz) 3 A/m 3 A/m Power frequency

magnetic field IEC 61000-4-8 magnetic fields should
be at levels characteristic
of a typical location in
a typical commercial or
hospital environment.

NOTE: Ut is the a.c. mains voltage prior to application of the test level.

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.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment--Guidance

Portable and mobile RF communications equipment

should be used no closer to any part of the Crossfire 2
system, including its cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.

Conducted RF 3 Vrms Recommended Separation Distance:

3V
IEC 61000-4-6 150 kHz to 80 MHz d = 1.2√P

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 Radiated RF 3 V/m 3 V/m d = 1.2√P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz d = 2.3√P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).

Field strengths from fixed RF transmitters, as determined

by an electromagnetic site survey (a), should be less that
the compliance level in each frequency range (b).
Interference may occur in the vicinity of equipment
marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.

(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to fixed 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.

(b) Over the frequency range 150 kHz to 80 Mhz, field strengths should be less than 3 V/m.

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. The user of the Crossfire 2 System can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Crossfire 2 System as
recommended below, according to the maximum output power of the communications equipment.

Rated maximum output Separation distance (m) according to frequency of transmitter

power (W) of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 3.7

10 3.7 2.3 7.4

100 11.7 11.7 23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.

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 Symbols
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.

Warning

Follow instructions for use Warning

Caution Dangerous voltage

Front Console

On / Off Select

Up Down

Menu Footswitch

RF probe Shaver handpiece

Type BF applied part

Rear Console

Equipotentiality USB

Stryker firewire Emits RF radiation

Protective earth (ground) Equipotentiality

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 Compliant to CSA C22.2
Fuse rating No. 601.1-M90, and UL
601-1

Fulfills requirements of the

European Medical Device Alternating current
Directive 93/42/EEC
This product contains
electrical waste or
Does not contain the electronic equipment. It
hazardous substances listed in must not be disposed of as
China regulation SJ/T11364 unsorted municipal waste
and must be collected
separately.

Complies with Australian

regulatory requirements,
Supplier ID: N 17693

LCD

Electrosurgical unit Contrast

Brightness Sound

Packaging/Labeling
Manufacturer Date of manufacture

Authorized representative in
Catalogue number
the European Community

Serial number Humidity limitation

Atmospheric pressure
Temperature limit
limitation

Caution: Federal law (USA)

restricts this device to sale
Made in USA
by, or on the order of, a
physician.

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 Fragile Consult instructions for use

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 Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
1-800-624-4422
U.S. Patents: www.stryker.com/patents

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 2017/06

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