DRAFT

Crossfire™ 2
REF 0475100000
Contents
Warnings and Cautions......................................................................3

Product Description/Intended Use.................................................7

Package Contents.................................................................................8
Available Accessories............................................................................8
The Crossfire 2 Console.........................................................................9
The Crossfire 2 Interface......................................................................11

Arthroscopy Mode. ...........................................................................12

Indications for Arthroscopic Use..........................................................12
Setup and Device Connections............................................................13
Adjusting User and System Settings.....................................................17
Arthroscopic Shaver Controls...............................................................19
RF Ablation Controls...........................................................................25
Dual Controls......................................................................................30

Laparoscopy Mode............................................................................32
Indications for Laparoscopic and General Surgery Use..........................32
Setup and Device Connections............................................................33
Adjusting User and System Settings.....................................................36
Vessel Sealing Controls........................................................................38

Troubleshooting................................................................................44
Error Codes.........................................................................................46

Cleaning and Maintenance.............................................................47

Cleaning.............................................................................................47
Maintenance......................................................................................47
Disposal.............................................................................................48

Technical Specifications...................................................................49
Generator Output...............................................................................50
Electromagnetic Compatibility............................................................55
Symbol Glossary.................................................................................59

EN-1
Warnings and Cautions
Please read this manual and follow its instructions carefully. The words
warning, caution, and note carry special meanings and should be carefully
reviewed:

Warning Warnings indicate risks to the safety of the patient or user.

Failure to follow warnings may result in injury to the patient

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or user.
Caution Cautions indicate risks to the equipment. Failure to follow
cautions may result in product damage.
Note Notes provide special information to clarify instructions or
present additional useful information.

To avoid potential serious injury to the user and the patient and/or
damage to this device, the user must obey the following warnings. The
warranty is void if any of these warnings is disregarded.

1. Caution: Federal law (USA) restricts this device to use by, or on order of, a
physician.
2. Attempt no internal repairs or adjustments not specifically detailed in this
operating manual. Refer any readjustments, modifications, and/or repairs
to Stryker Endoscopy or its authorized representatives.
3. Pay close attention to the care and cleaning instructions in this manual.
Failure to follow these instructions may result in product damage.
4. Install this device in an operating room that complies with all applicable
IEC, CEC, and NEC requirements for safety of electrical devices.
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.

Fire/Explosion Warnings
1. DO NOT use this device in the presence of flammable anaesthetics, other
flammable gases or objects, near flammable fluids such as skin prepping
agents and tinctures, or oxidizing agents. Observe appropriate fire
precautions at all times.
2. DO NOT use this device in oxygen-enriched atmospheres, nitrous oxide
(N₂O) atmospheres, or in the presence of other oxidizing agents, to
prevent risk of explosion. Ensure that oxygen connections are not leaking.
EN-3
3. Electrosurgical components, such as the probe, may remain hot following
activation. Keep all electrosurgical equipment away from flammable
materials to avoid combustion.
4. To prevent the risk of fire, DO NOT replace console fuses. If it is
suspected that fuses are damaged, return console to Stryker for repair.

Prior to Surgery

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1. The operator of the Crossfire 2 system should be a qualified physician,
having complete knowledge of the use of this equipment and awareness
of the risks associated with arthroscopic and laparoscopic electrosurgical
procedures.
2. The operator of the Crossfire 2 system should be experienced in
arthroscopic and electrosurgical practices and techniques.
3. The operator of the Crossfire 2 system should read this manual
thoroughly and be familiar with its contents prior to operating the
equipment.
4. The operator of the Crossfire 2 system should be sure that the system
functions as outlined in this manual prior to a surgical procedure. The
Crossfire 2 system was fully tested at the factory before shipment.
5. 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.
6. Carefully unpack the unit and ensure that all components are accounted
for and remain undamaged from shipment. Inspect the handpiece cable
for any damage to insulation. If damage to any component is detected,
refer to the “Service and Claims” section of this manual.
7. Ensure the proper connection of the primary power cord of the
Crossfire 2 System to a grounded receptacle. To prevent risk of electric
shock DO NOT use extension cords or adapter plugs.
8. DO NOT wrap the handpiece cable around metal objects, or the induction
of hazardous currents may result.
9. Position the cables to avoid contact with the patient, electrodes, cables,
and any other electrical leads which provide paths for high frequency
current.
10. Position the console so the fan directs the flow of air away from the
patient.
11. 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
EN-4
 monitoring electrodes are NOT recommended.
12. Smoke generated during electrosurgical procedures may be harmful to
surgical personnel. Take appropriate precautions by wearing surgical
masks or other means of protection.

During Surgery
1. DO NOT use the Crossfire 2 system with non-conductive irrigants (e.g.

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sterile water, air, gas, glycine, etc.). Use only conductive irrigants such as
saline or Ringer’s lactate in order for the system to function properly.
2. 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, to prevent risk of shock. The
use of antistatic sheeting is recommended for this purpose.
3. 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.
4. 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.
5. Select the lowest output power required to prevent patient injury.
6. Maintain the active electrode in the field of view at all times to avoid
tissue damage.
7. Remove the handpiece and disposable attachments from the surgical site
and place them away from metallic objects when not in use. 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.
8. Keep the ends of the handpiece cable connectors, footswitch cable
connectors, and console receptacles away from all fluids.
9. DO NOT activate the Crossfire 2 system until the probe is properly
positioned in the patient.
10. Ensure that the probe tip, including the return electrode, is completely
surrounded by irrigant solution during use.
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.
12. DO NOT touch the attachment to metal objects, such as an endoscope
or metal cannula, while activating the handpiece. Damage to the
attachments or other devices may result.
EN-5
13. DO NOT obstruct the fan (located near the rear of the console).
14. Failure of the system may result in an unintended increase in output
power.
15. During use, operators should wear standard surgical gloves to help
reduce the risk of electric shock.

After Surgery

DRAFT
1. 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.
2. DO NOT use flammable agents for cleaning and disinfection of the
Crossfire 2 console, handpiece, or footswitch.
3. DO NOT remove the cover of the console as this could cause electric
shock and product damage.
4. Attempt no internal repairs or adjustments, unless specified otherwise in
this manual. Units requiring repair should be returned to Stryker.
5. Disconnect the Crossfire 2 system from the electrical output when
inspecting fuses.

EN-6
Product Description/Intended Use
The Crossfire 2 Integrated Resection and Sealing System is a combination
powered shaver system/electrosurgical generator that powers arthroscopic
shaver handpieces, RF surgical probes, and vessel-sealing handpieces for use
in a variety of arthroscopic, orthopedic, and general laparoscopic surgeries.
Illustrated below, the Crossfire 2 system consists of the following components:

DRAFT
1

5
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 vessel sealing and the
electrosurgical cutting and coagulation of tissue
• Provides a central user interface for operating the Crossfire 2 system

2. Disposable RF probe
Enables RF cutting and coagulation

3. Powered shaver handpiece (and disposable attachments)

Enables arthroscopic cutting and debridement

4. Crosseal Handpiece
Enables vessel sealing

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

EN-7
Package Contents
Carefully unpack the Crossfire 2 console and inspect each of the following
components. Report any damaged components to Stryker.
(1) Crossfire 2 console
(1) Hospital-grade power cord
(1) User guide

DRAFT
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

Laparoscopy Accessories
0250-080-800 35 cm Crosseal Vessel Sealing Handpiece
0250-080-850 45 cm Crosseal Vessel Sealing Handpiece

EN-8
The Crossfire 2 Console
The Crossfire 2 console is the connection hub for the components of the
Crossfire 2 system. It generates RF energy for ablation and vessel sealing,
powers motorized shavers, and provides user controls and system feedback.

Front Panel
The front console panel features ports for connecting handpieces, controls for

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adjusting handpiece settings, and an LCD screen to provide system feedback.

1 2 3 4

CROSSFIRE II INTEGRATED RESECTION AND SEALING SYSTEM

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 or
(SERFAS Energy and vessel sealing handpieces
Crosseal Handpieces)
4. Handpiece connector Powered shaver handpiece

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 Crossfire Footswitch

EN-9
Rear Panel
The rear panel provides ports for connecting the console to other Stryker
equipment.

1 2 3 4

DRAFT
1. Firewire Connectors Enables connection to other Stryker
Firewire devices, such as the iSWITCH
Universal Wireless Footswitch
2. USB Drive Enables software installation from
authorized service personnel
3. Equipotential —
Ground Plug

4. AC Power Inlet —

EN-10
The Crossfire 2 Interface
The Crossfire 2 interface displays system status, enables you to choose
between RF ablation, RF vessel sealing, and shaver modes, and enables you to
adjust power and speed settings.
Activating the actual handpieces is performed through controls on the
handpiece and on the Crossfire Footswitch.

DRAFT
1 2 3 4 5

Control Description
1. Menu The Menu button opens a menu for selecting user and
system settings.
2. Error The Error indicator shines red when a system error
indicator 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.

EN-11
Arthroscopy Mode

Indications for Arthroscopic Use

The Stryker Crossfire 2 system is indicated for use in orthopedic and
arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow,
wrist, and hip. The crossfire system provides abrasion, resection, debridement

DRAFT
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 prodict include resection
of torn knee cartilage, subcromial 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.

EN-12
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.

DRAFT
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.

EN-13
 1. Place the console on a sturdy platform, such as a Stryker cart.
• Select a location according to the recommendations in the preceding
EMC tables.
• Leave four inches of space around all sides for convection cooling.

DRAFT 2. Connect the AC power.

3. Connect the handpieces and

footswitch. (Note: Vessel sealing
handpieces are not intended to
ING SYSTEM
be connected during arthroscopic
procedures.)

The console will display an error

message if expired or used
attachments are connected:

4. Connect suction tubing (for all

suction-capable devices).

EN-14
Using the iSWITCH Wireless Footswitch
The Crossfire 2 system can be used with the iSWITCH Wireless Footswitch
System.

DRAFT
1. Connect the Crossfire 2 console to the iSWITCH console using one of
the Firewire connection ports on each console.
2. Consult the iSWITCH Operating and Maintenance Manual (P/N 1000-
400-700) for further operation instructions.

EN-15
Powering the Console On and Off
Press the power button to power the console on and off. The button will shine
green when the console is on.

Warning
DRAFT
Should emergency shutdown become necessary, power
off the console as described above. As an added safety
measure, the console can be separated from the AC power
mains by detaching the AC power cord from either end.

EN-16
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

DRAFT
Stryker representative to customize your own.

1. Press . DEFAULT
SMITH KNEE
SMITH SHLDR
2. Press to select a
default setting.

3. Press to confirm
selection and exit.
Or, press to cancel
selection.

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

EN-17
System Settings
System settings, such as screen brightness, contrast, and system sound can be
adjusted through the Crossfire 2 interface.

1. Press and hold .

(Note: If an RF probe is connected to

DRAFT
the console, the COAG adjustment
screen will appear. Press again to
access the system settings screen.)

2. Press to choose (contrast), (brightness), or (sound). (The

will indicate your selection.)

3. Press to adjust.

4. Press and hold to exit.

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

EN-18
Arthroscopic Shaver Controls
Warning The Crossfire 2 system is intended for use only by licensed
medical professionals, properly trained in the use of
electrosurgical equipment and techniques. The Crossfire 2
system generates potentially hazardous levels of energy
that can result in injury or even death if improperly used.

Before using the Crossfire 2 system in an actual procedure, verify that each

DRAFT
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.

Warning During use, the RF, Crosseal, and shaver handpieces

generate electronic noise that may interfere with EKG
readings. Before responding to any erratic EKG readings,
first power down the system to ensure the readings are not
the result of system noise.
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.

EN-19
Default Handpiece Controls
Default 1 Default 2 / Default 3
None

1. Oscillate Activate / Oscillate

(one touch) Deactivate (one touch)
1
1 TOUCH
TOUCH

DRAFT
2 2. Forward Select Mode: Jog
(one touch) Oscillate or
3 1
TOUCH Forward /
Reverse

3. Reverse Forward/ Forward

(one touch) Reverse (one touch)
1 1
TOUCH TOUCH

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.

EN-20
Default Footswitch Controls
The RF and shaver handpieces can also be controlled by the Crossfire
Footswitch. The default footswitch controls for the shaver handpiece are
shown below. To customize button assignments, contact your Stryker
representative.

DRAFT
Button Function

Default 1 Default 2 / None Default 3

I Jog Select Mode: Select Mode:

Oscillate or Oscillate or
Forward/Reverse Forward/Reverse

II Select Handpiece: Select Handpiece: Select Handpiece:

RF or Shaver RF or Shaver RF or Shaver

III Select Direction: Select Speed: Select Speed:

Forward or Reverse High or Low High or Low

A Oscillate Oscillate/Reverse Oscillate/Reverse

(fixed) (variable) (fixed)
FIXED VAR FIXED

B Forward/Reverse Oscillate/Forward Oscillate/Forward

(variable) (variable) (fixed)
VAR VAR FIXED

EN-21
Note: When using small-joint handpieces, only Default 2 settings are
available. No other defaults or user preferences can be applied.

Adjusting Cutting Speed

Use the buttons on the console to manually adjust the power or
speed setting for the active handpiece.
Note: In shaver mode, the console uses radio frequency identification (rfid) to
automatically detect which type of disposable attachment is connected to the

DRAFT
handpiece. Upon recognition, the console adjusts to an optimal preset cutting
speed, direction, and power.
Note: Forward and reverse settings are adjusted independent of each other.
Adjusting settings in one mode will not affect the other.

EN-22
Reading the LCD
In shaver mode, the LCD will show:

1 2

9000
VAR

DRAFT
MC DISP NAME
3 5
4
1. Footswitch Crossfire Footswitch connected
status
iSWITCH footswitch connected

not connected
2. Footswitch 1
TOUCH
one touch
response (pressing the foot pedal once will activate the
shaver to a default speed; pressing again will stop
it)
FIXED
fixed
(pressing the foot pedal at any pressure will result
in a constant speed)
VAR
variable
(shaver speed will vary, 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

EN-23
System Feedback
Event Audible Feedback Visible Feedback
(via LCD)

Reverse activated five high beeps R

Forward activated/ low beep F

resumed

DRAFT
Adjustments made to one beep for each unit Speed indicator
speed settings of change number increases or
decreases

EN-24
RF Ablation Controls

Warning During use, the RF, Crosseal, and shaver handpieces

generate electronic noise that may interfere with EKG
readings. Before responding to any erratic EKG readings,
first power down the system to ensure the readings are not
the result of system noise.

DRAFT
RF and Crosseal handpieces are intended for single use only and should not
be reprocessed or reused.

Default handpiece controls

1. Adjust CUT power level (single press)

or

1 Activate/deactivate Force Modulation

(press and hold for three seconds)
2
2. Activate CUT
3
3. Activate COAG

EN-25
Default footswitch controls
The RF and shaver handpieces can also be controlled by the Crossfire
Footswitch. The default footswitch controls for the RF probe are shown below.
To customize button assignments, contact your Stryker representative.

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

I Decrease Cut Level

II Select Handpiece:
RF or Shaver

III Increase Cut Level

A Cut

B Coag

EN-26
Adjusting CUT power
To adjust CUT power:

• Press the buttons on the console

• Press the gray button on the handpiece (increase)
• Press the I (decrease) and III (increase) buttons on the footswitch

Adjusting COAG power

DRAFT
To adjust COAG power:

COAG1
1. Press and hold . The COAG POWER COAG2
LEVEL screen will appear. COAG3
COAG POWER LEVEL

2. Press to adjust.

3. Press 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.

EN-27
Reading the LCD
In RF ablation mode, the LCD will show:

1
2
5

11 6

DRAFT
. . . HC
3 SERFAS

4 7
1. Footswitch status Crossfire Footswitch connected

iSwitch footswitch connected

not connected

2. Mode cut mode activated

coagulation mode activated

3. Force modulation force modulation activated

force modulation not activated

4. COAG power low

medium

high

5. Hand controls
hand control is enabled

hand control is disabled

6. CUT power (#) power setting

7. Disposable RF
(name)
probe name

EN-28
System Feedback
Event Audible Feedback Visible Feedback
(via LCD)

CUT activated high, steady tone

COAG activated low, steady tone

DRAFT
Force modulation Single beep
on / off

System error Ten short beeps

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

Change footswitch to “SERFAS” “SERFAS” appears

control RF mode

Change footswitch to “Shaver” disposable name

control Shaver mode appears

EN-29
Dual Controls
In arthroscopic procedures, RF probes and arthroscopic shaver handpieces
can be simultaneously connected to the Crossfire 2 system, enabling users to
toggle quickly between RF ablation and arthroscopic functions.

Selecting between RF Ablation Mode and Arthroscopic

Shaver Mode for Footswitch Control

DRAFT
Selecting a mode will enable the selected handpiece to be controlled by the
footswitch. To select the appropriate mode, do one of the following:

• Press on the Crossfire 2 interface. 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 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. (The active is
identified by handpiece appears on the right side of the LCD.)

EN-30
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.

11 9000
FIXED Dual mode, shaver

F
handpiece controlled by

DRAFT
footswitch.

SERFAS MC DISP NAME

9000 11
FIXED
Dual mode, RF probe
F controlled by 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 to move the desired handpiece to the right side of the LCD.

2. Use the buttons on the console to manually adjust the power or

speed setting for the selected handpiece.

EN-31
Laparoscopy Mode

Indications for Laparoscopic and

General Surgery Use
The Stryker Crossfire 2 system is indicated for use in laparoscopic general and

DRAFT
gynecological surgical procedures (including urologic, thoracic, plastic and
reconstructive, bowel resections, hysterectomies, cholecystectomies, gall
bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies,
etc.), or any procedure where vessel ligation (cutting and sealing), tissue
grasping and dissection is performed. The devices can be used on vessels
up to and including 7 mm and bundles as large as will fit in the jaws of the
instruments.

Contraindications
• The system should not be used with atherosclerotic vessels (calcified
vessels) as vessels will not seal.
• Crosseal should not be used in procedures where a nonconductive
irrigant is used or with patients having cardiac pacemakers or other
electronic implants.
• The Crosseal system should not be used for tubal ligation.

EN-32
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.

DRAFT
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.

EN-33
 1. Place the console on a sturdy platform, such as a Stryker cart.
• Select a location according to the recommendations in the preceding
EMC tables.
• Leave four inches of space around all sides for convection cooling.

DRAFT 2. Connect the AC power.

ION AND SEALING SYSTEM

3. Connect the handpiece and

footswitch. (Note: Arthroscopic
handpieces are not intended to
be connected during laparoscopic
procedures.)

EN-34
Using the iSWITCH Wireless Footswitch
The Crossfire 2 system can be used with the iSWITCH Wireless Footswitch
System.

DRAFT
1. Connect the Crossfire 2 console to the iSWITCH console using one of
the Firewire connection ports on each console.
2. Consult the iSWITCH Operating and Maintenance Manual (P/N 1000-
400-700) for further operation instructions.

Powering the Console On and Off

Press the power button to power the console on and off. The button will shine
green when the console is on.

EN-35
 Warning Should emergency shutdown become necessary, power
off the console as described above. As an added safety
measure, the console can be separated from the AC power
mains by detaching the AC power cord from either end.

Adjusting User and System Settings

DRAFT
User Preference Settings
User preferences, such as button assignments for the handpiece and
footswitch, can be adjusted through the Crossfire 2 interface.
Select from the default settings provided with the console, or contact your
Stryker representative to customize your own.

1. Press . DEFAULT
SMITH KNEE
SMITH SHLDR
2. Press to select a
default setting.

3. Press to confirm
selection and exit.
Or, press to cancel
selection.

EN-36
System Settings
System settings, such as screen brightness, contrast, and system sound can be
adjusted through the Crossfire 2 interface.

1. Press and hold .

DRAFT
2. Press to choose (contrast),
(brightness), or (sound). (The will
indicate your selection.)

3. Press to adjust.

4. Press and hold to exit.

(Note: A short press will display

the current version of the console
software.)

EN-37
Vessel Sealing Controls

Warning The Crossfire 2 system is intended for use only by licensed

medical professionals, properly trained in the use of
electrosurgical equipment and techniques. The Crossfire 2
system generates potentially hazardous levels of energy
that can result in injury or even death if improperly used.

DRAFT
Before using the Crossfire 2 system in an actual procedure, verify that each
component is installed and functioning properly. 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.

Warning During use, the RF, Crosseal, and shaver handpieces

generate electronic noise that may interfere with EKG
readings. Before responding to any erratic EKG readings,
first power down the system to ensure the readings are not
the result of system noise.

RF and Crosseal handpieces are intended for single use only

and should not be reprocessed or reused.

EN-38
Default Handpiece Controls

3
2

DRAFT
1

1. grasp

2. seal

3. cut (mechanically)

Note: For complete instructions on how to use the Crosseal handpiece,

consult the Crosseal Handpiece User Guide (P17278).

EN-39
Default footswitch controls
The RF and shaver handpieces can also be controlled by the Crossfire
Footswitch. The default footswitch controls for the vessel sealing handpiece
are shown below. To customize button assignments, contact your Stryker
representative.

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

I Decrease Seal Level

II Select Handpiece:
RF, Crosseal, or Shaver

III Increase Seal Level

A Activate/Seal

B Activate/Seal

EN-40
Reading the LCD
In vessel sealing mode, the LCD will show:

1 2 3
4
SEAL
3 5

DRAFT
HC
VESSEL SEALER

6
1. Progress
indicates progress of vessel sealing
indicator
2. Footswitch status Crossfire Footswitch connected

iSwitch footswitch connected

not connected

3. Sealing status SEAL vessel sealing in progress

vessel sealing not in progress

4. Seal power
(#) power setting

5. Hand controls hand control is connected and its

buttons are active
6. Handpiece
vessel sealing handpiece is connected
indicator

EN-41
System Feedback

Event Audible Feedback Visible Feedback

(via LCD)

Sealing activated / steady tone SEAL

in progress

DRAFT
progress bar

Sealing complete two high beeps SEAL

progress bar

Sealing error alternating high/low

tones

vessel-sealing error

EN-42
Vessel-Sealing Errors
During vessel sealing, the Crossfire 2 system will indicate sealing progress.
Should a seal be unsuccessful, the LCD will display an appropriate error
message:

1 1

1.
2

Error Code
DRAFT 2.
Description
3 2

Solution
3

A1 No Vessel Found

A2 Incomplete Seal Regrasp tissue and retry seal

A3 Incomplete Seal

EN-43
Troubleshooting
Problem Possible Solution
Console A hardware fault is • Turn the power off and on again.
detected • If the problem persists, contact a
Stryker representative or return
the console for repair.

DRAFT
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 is • Turn the power off and on again.
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
not power on is properly connected.
• Check to ensure the cord is
connected to a grounded outlet.
The electrical • Power down all electrical
interference is equipment not in use.
sporadic • Increase distance of other
electrical equipment.
• Connect the unit and other
equipment into different outlets.
The generator • Ensure that there is proper airflow
temperature is too around the unit.
high
A power-on self • Turn the power off and on again.
test error has • If the problem persists, contact a
occurred Stryker representative or return
the console for repair.

EN-44
Hand- The temperature • Allow the unit to cool before
piece is higher than restarting.
normal
The unit has • Contact your Stryker
reached its representative.
recommended
service interval

DRAFT
Disposable RF probe is not • Check the connection to the
Attachments ready console.
RF probe is • Replace probe.
expired
RF probe • Replace probe.
identification is
invalid
RF probe • Check the connection to the
communication console.
error • If necessary, replace probe.
Exceeded time • Replace probe
usage
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
appear the cable or connector.

EN-45
Note: If a disturbance occurs on the video monitor, the user should ensure
that the probe cable is not near any other instrument cables.

Error Codes
When the Crossfire 2 system encounters an error, it will display an error
code on the LCD. Error codes are grouped into general categories that share
common solutions:

DRAFT 1

1. 2.
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

EN-46
Cleaning and Maintenance

Cleaning

Console

DRAFT
Should the console need cleaning, wipe it down with a sterile cloth and mild
cleaning solution. If needed, wipe the console with a disinfectant.
Warning To avoid electric shock and potentially fatal injury,
unplug the Crossfire 2 console from the electrical outlet
before cleaning.

Do not sterilize the console or immerse it in any liquid.

Doing so will damage the unit.

Do not clean the console with alcohol, solvents, or

cleaning solutions that contain ammonia. Doing so will
damage the unit.

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.

EN-47
Disposal
This product contains electrical waste or electronic equipment.
It must not be disposed of as unsorted municipal waste and
must be collected separately in accordance with applicable
national or institutional related policies relating to obsolete
electronic equipment.
Dispose of any system accessories according to normal institutional practice

DRAFT
relating to potentially contaminated items.

EN-48
Technical Specifications
Stryker Endoscopy reserves the right to make improvements to the product(s)
described herein. Product(s), therefore, may not agree in detail to the
published design or specifications. All specifications are subject to change
without notice. Please contact the local Stryker Endoscopy distributor or call
your local Stryker Endoscopy sales representative or agent for information on
changes and new products.

DRAFT
Dimensions
Size: 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

Voltage: 100-240 VAC @ 50/60Hz, 6 – 10 A
Inlet Fuse: 15 A, 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

EN-49
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 Output

versus Setting
Power versus at 200ohms
Setting Resistive
at 200 Ohm Load Load
400

DRAFT
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 Output

(CUT)Power
versus Load
(Cut) Resistance
versus Load Resistance

400

350

300
Half Setting Full Setting
250
(Power (W)

200

150

100

50

0
0 100 200 300 400 500 600 700 800 900 1000
Load Resistance (ohms)

EN-50
Output PowerOutput
(COAG) versus
Power (Coag)Load
versusResistance
Load Resistance

100

90

80

70 Coag 1
60 Coag 2
Power (W)

Coag 3
50

DRAFT
40

30

20

10

0
0 100 200 300 400 500 600 700 800 900 1000
Load Resistance (Ohms)

Maximum Output Voltage (RMS) versus Setting

Maximum Open Circuit Voltage versus Set Point
400

350

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

EN-51
Classifications
Warning This equipment is not suitable for use in the presence
of a flammable anesthetic mixture with air, oxygen, or
nitrous oxide.

• Class I equipment
• Type BF applied part
• Degree of protection against harmful ingress of water

DRAFT
• Generator: IEC 60601-2-2: Requirement per clause 44.3
• Probe: IEC 60601-2-2: Requirement per clause 44.6
• Footswitch: IEC 60601-2-2: Requirement per clause 44.6,
IPX7 Water-tight Equipment

Approvals
Complies with medical safety standards:
• IEC 60601-1: 1998 + A1:1991 + A2:1995
• AS 3200.1.0: 1998
• IEC 60601-1-2: 2001
• IEC 60601-2-2: 2006
• UL 60601-1: 2003
• CSA C22.2 No. 601-1-M90

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

EN-52
Industry Canada (IC)
IC: 4919C-XFC2
Trade Name: Crossfire 2 Console
Type or Model: 0475100000

Operation is subject to the following two conditions: (1) this device may
not cause interference, and (2) this device must accept any interference,
including interference that may cause undesired operation of the device.

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

EN-53
R&TTE Declaration of Conformity (DoC)
We, Name of company: Stryker Endoscopy
Address: 5900 Optical Court, San Jose, CA 95138
Authorized representative: Jean-Yves Carentz
Contact detail of authorized representative: Stryker France,
ZAC Satolas Green Pusignan, Av. de Satolas Green, 69881
MEYZIEU Cedex, France

DRAFT
Declare under our sole responsibility that the product:

Product name: Crossfire 2 Integrated Arthroscopy System

Trade Name: Crossfire 2 Console
Type or Model: 0475100000
Relevant Supplementary Information: None

to which this declaration relates is in conformity with the essential

requirements and other relevant requirements of the R&TTE Directive
(1999/5/EC).
The product is compliant with the following standards and/or other
normative documents:

Safety: EN 60601-1:1990+A1:1993+A2:1995+A13:1996
EMC: EN 60601-1-2:2007; EN 61000-3-2:2006
Radio Spectrum: EN 300 330-1 V1.5.1

Supplementary information: none

Notified body involved: TÜV Rheinland Product Safety
(GmbH)
Technical file held by: Stryker Endoscopy
Place and date of issue (of this DoC): San Jose, CA USA,
August 2009

Signed by or for the manufacturer:

Name: K. Jeffrey Semone

Title: Director, Regulatory Affairs

Hereby, Stryker Endoscopy declares that this Short Range Device is in

compliance with the essential requirements and other relevant provisions of
Directive 1999/5/EC.

EN-54
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

DRAFT
60601-1-2:2001 requirements for EMC with other devices.

Warning 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.

EN-55
When the Crossfire 2 System is interconnected with other medical electrical
equipment, leakage currents may be additive. To minimize total patient
leakage current, any Type BF applied part should be used together with
other Type BF applied parts. Any Type CF applied part should be used
together with other Type CF applied parts. Ensure all systems are installed
according to the requirements of IEC 60601-1-1.

The separable AC power cord is provided as a means of emergency

DRAFT
shutdown and disconnection from the power source. Do not position the
console in a way that is difficult to disconnect the AC power cord.

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
Harmonic emissions IEC 61000- Class A
those directly connected to the public
3-2
low-voltage power supply network that
Voltage Fluctuations/flicker Complies supplies buildings used for domestic
emissions IEC 61000-3-3 purposes.

EN-56
 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 ±6kV contact ±2,4,6kV contact ±2,4,8kV Floors should be wood,
Discharge (ESD) IEC ±8kV air air concrete, or ceramic tile.
61000-4-2 If floors are covered with
synthetic material, the
relative humidity should

DRAFT
be at least 30%.
Electrical fast ±2kV for power supply ±2kV for power supply Mains power quality
transient/burst IEC lines ±1kV for input/ lines ±1kV for input/ should be that of a typical
61000-4-4 output lines output lines commercial or hospital
environment.
Surge ±1kV differential mode ±0.5, 1kV differential Mains power quality
IEC 61000-4-5 ±2kV common mode mode ±1, 2kV common should be that of a typical
mode commercial or hospital
environment.
Voltage dips, short <5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut) Mains power quality
interruptions and for 0.5 cycle for 0.5 cycle should be that of a typical
voltage variations 40% Ut (60% dip in Ut) for 40% Ut (60% dip in Ut) commercial or hospital
on power supply 5 cycles for 5 cycles environment. If the user
input lines IEC 70% Ut (30% dip in Ut) for 70% Ut (30% dip in Ut) for of Crossfire 2 System
61000-4-11 25 cycles 25 cycles requires continued
<5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut) operation during power
for 5 sec. for 5 sec. mains interruptions,
it is recommended
that Crossfire 2 System
be powered from an
uninterruptible power
supply or a battery.
Power frequency 3 A/m N/A Power-frequency
(50/60Hz) magnetic magnetic fields should
field IEC 61000-4-8 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.

EN-57
 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 Compliance Level Electromagnetic Environment: Guid-
Level ance
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

DRAFT
calculated from the equation applicable
to the frequency of the transmitter.
Recommended Separation Distance d
= 1.17 √P

Conducted RF 3 Vrms 150 kHz to 3V d = 1.17 √P

IEC 61000-4-6 80 MHz 80 MHz to 800 MHz

Radiated RF IEC 3 V/m 3 V/m d = 2.33 √P

61000-4-3 80MHz to 2.5 GHz 80 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 than 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.

EN-58
 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 Separation distance (m) according to frequency of transmitter
output power (W) of
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter

DRAFT
0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 3.70

10 3.70 2.33 7.37

100 11.70 11.70 23.30

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.

Symbol Glossary
This device and its labeling contain symbols that provide important
information for the safe and proper use of the device. These symbols are
defined below.

Warning Symbols
Warning/Caution:
See instructions for Hazardous voltage present
use

Front Console Symbols

Power Select

Up Down

EN-59
 MENU Menu Footswitch

Probe Shaver handpiece

Directed energy

DRAFT
handpiece

Rear Console Symbols

Equipotentiality USB

Stryker firewire Emits RF radiation

Type CF rated Protective ground earth

Compliant to CSA C22.2 No.

Fuse rating
601.1-M90, and UL 601-1

Fulfills requirements
of the European
Medical Device
Directive 93/42/EEC

LCD Symbols

Electrosurgical unit Contrast

Brightness Sound

EN-60
Packaging/Labeling Symbols
Authorized representative in
Legal manufacturer
Europe

Date of manufacture Atmospheric pressure range

DRAFT
Ambient
Relative humidity range
temperature range

LOT Lot number Product number

SN Serial number Fragile

This product contains electrical waste or electronic equipment.

It must not be disposed of as unsorted municipal waste and
must be collected separately.

EN-61
 DRAFT

EN-62
DRAFT
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
1-408-754-2000, 1-800-624-4422
www.stryker.com

European Representative:
Regulatory Manager, Stryker France
ZAC Satolas Green Pusignan
Av. De Satolas Green
69881 MEYZIEU Cedex, France

P13827 draft 2
2011/10