Stryker Endoscopy XFC2 Crossfire 2 Console User Manual

Stryker Endoscopy Crossfire 2 Console

user manual

Crossfire™ 2
REF 0475100000
DRAFT
EN-1
Contents
Warnings and Cautions .....................................................................3
Product Description/Intended Use ................................................7
Package Contents ................................................................................8
Available Accessories ...........................................................................8
The Crossre2 Console ........................................................................9
The Crossre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 Specications ..................................................................49
Generator Output ..............................................................................50
Electromagnetic Compatibility ...........................................................55
Symbol Glossary ................................................................................59
EN-3
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Warnings and Cautions
Please read this manual and follow its instructions carefully. The words
warning, caution, and note carry special meanings and should be carefully
reviewed:
Warning Warnings indicate risks to the safety of the patient or user.
Failure to follow warnings may result in injury to the patient
or user.
Caution Cautions indicate risks to the equipment. Failure to follow
cautions may result in product damage.
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 specically detailed in this
operating manual. Refer any readjustments, modications, 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 Crossre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 ammable anaesthetics, other
ammable gases or objects, near ammable uids such as skin prepping
agents and tinctures, or oxidizing agents. Observe appropriate re
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-4
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3. Electrosurgical components, such as the probe, may remain hot following
activation. Keep all electrosurgical equipment away from ammable
materials to avoid combustion.
4. To prevent the risk of re, DO NOT replace console fuses. If it is
suspected that fuses are damaged, return console to Stryker for repair.
Prior to Surgery
1. The operator of the Crossre2 system should be a qualied 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 Crossre2 system should be experienced in
arthroscopic and electrosurgical practices and techniques.
3. The operator of the Crossre2 system should read this manual
thoroughly and be familiar with its contents prior to operating the
equipment.
4. The operator of the Crossre2 system should be sure that the system
functions as outlined in this manual prior to a surgical procedure. The
Crossre2 system was fully tested at the factory before shipment.
5. Crossre2 system components are designed to be used together as a
system. Use only the appropriate footswitch, handpiece, and disposable
attachments described in this manual.
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
Crossre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 ow of air away from the
patient.
11. When the Crossre2 system and physiological monitoring equipment
are used simultaneously on a patient, position any monitoring electrodes
as far as possible from the surgical electrodes. Monitoring equipment
using high frequency, current-limiting devices is recommended. Needle
EN-5
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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 Crossre2 system with non-conductive irrigants (e.g.
sterile water, air, gas, glycine, etc.). Use only conductive irrigants such as
saline or Ringer’s lactate in order for the system to function properly.
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 Crossre2 system for prolonged lengths of time
when the attachment is not in contact with tissue. Doing so may lead to
unintentional damage to surrounding tissue.
4. When the Crossre2 system is activated, the conducted and radiated
electrical elds may interfere with other electrical medical equipment.
Provide as much possible distance between the console and other
electronic medical equipment.
5. Select the lowest output power required to prevent patient injury.
6. Maintain the active electrode in the eld 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 uids.
9. DO NOT activate the Crossre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 eld 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.
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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
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 ammable agents for cleaning and disinfection of the
Crossre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 specied otherwise in
this manual. Units requiring repair should be returned to Stryker.
5. Disconnect the Crossre2 system from the electrical output when
inspecting fuses.
EN-7
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Product Description/Intended Use
The Crossre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 Crossre2 system consists of the following components:
2
1
3
5
4
1. Crossre2 Console (featured in this manual)
• Acts as a connection hub for the various components of the Crossre2
system
• Powers a motorized shaver handpiece for the mechanical cutting and
debridement of bone and soft tissue
• Generates bipolar radio frequency (RF) energy for vessel sealing and the
electrosurgical cutting and coagulation of tissue
• Provides a central user interface for operating the Crossre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. Crossre Footswitch
Provides remote, foot control of the powered shaver handpiece and RF
probe
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Package Contents
Carefully unpack the Crossre2 console and inspect each of the following
components. Report any damaged components to Stryker.
(1) Crossre2 console
(1) Hospital-grade power cord
(1) User guide
Available Accessories
The Crossre2 system is compatible with the following accessories:
System Accessories
0475-000-100 Crossre Footswitch
0277-200-100 iSWITCH Universal Wireless Footswitch Receiver
0277-200-101 iSWITCH Universal Wireless Footswitch Receiver (AUS)
0277-100-100 iSWITCH Universal Wireless Footswitch
6000-001-020 Stryker rewire cable
Arthroscopy Accessories
0279-xxx-xxx SERFAS Energy family of electrosurgical probes
0375-708-500 Formula 180 Handpiece
0375-704-500 Formula Handpiece (with buttons)
0375-701-500 Formula Handpiece (without buttons)
0275-601-500 Small-Joint Shaver Handpiece
Laparoscopy Accessories
0250-080-800 35 cm Crosseal Vessel Sealing Handpiece
0250-080-850 45 cm Crosseal Vessel Sealing Handpiece
EN-9
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The Crossre2 Console
The Crossre2 console is the connection hub for the components of the
Crossre2 system. It generates RF energy for ablation 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
adjusting handpiece settings, and an LCD screen to provide system feedback.
CROSSFIRE II
INTEGRATED RESECTION AND SEALING SYSTEM
1 2
5 6 7 8 9
3 4
1. Menu Selects menu items
2. Select Selects which device displays on
the LCD screen.
3. RF connector
(SERFAS Energy and
Crosseal Handpieces)
Delivers RF energy for ablation or
vessel sealing handpieces
4. Handpiece connector Powered shaver handpiece
5. Power Powers the console on and o
6. Error indicator Shines red to indicate errors
(error details appear in the LCD)
7. LCD screen Provides system feedback
8. Adjust Adjusts options for connected
devices
9. Footswitch connector Crossre 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 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-11
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The Crossre2 Interface
The Crossre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 Crossre Footswitch.
1 4 52 3
Control Description
1. Menu The Menu button opens a menu for selecting user and
system settings.
2. Error
indicator
The Error indicator shines red when a system error
occurs.
3. LCD screen The LCD screen displays system status, error codes, mode
of operation, cutting speed, and power levels.
4. Select The Select button toggles between RF and Shaver
controls. The selected device can then be controlled
using the Crossre2 interface.
5. Adjust The Adjust buttons increase/decrease speed and power
settings for the selected device.
EN-12
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Arthroscopy Mode
Indications for Arthroscopic Use
The Stryker Crossre 2 system is indicated for use in orthopedic and
arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow,
wrist, and hip. The crossre 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 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-13
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Setup and Device Connections
Stryker Endoscopy considers instructional training an integral part of the
Crossre2 system. Your Stryker Endoscopy sales representative will perform
at least one inservice at your convenience to help you set up your equipment
and instruct you and your sta on its operation and maintenance. Please
contact your local Stryker Endoscopy representative to schedule an 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 eld.
The Crossre2 System is compatible only with the Stryker handpieces and
footswitches listed in this manual. Do not connect any equipment not
specied in this manual, as unexpected results or serious injury will occur.
EN-14
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1. Place the console on a sturdy platform, such as a Stryker cart.
• Select a location according to the recommendations in the preceding
EMC tables.
• Leave four inches of space around all sides for convection cooling.
2. Connect the AC power.
CROSSFIRE II
INTEGRATED RESECTION AND SEALING SYSTEM
3. Connect the handpieces and
footswitch. (Note: Vessel sealing
handpieces are not intended to
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-15
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Using the iSWITCH Wireless Footswitch
The Crossre2 system can be used with the iSWITCH Wireless Footswitch
System.
1. Connect the Crossre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-16
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Powering the Console On and O
Press the power button to power the console on and o. The button will shine
green when the console is on.
Warning Should emergency shutdown become necessary, power
o 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-17
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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 Crossre2
interface.
Select from the default settings provided with the console, or contact your
Stryker representative to customize your own.
1. Press . DEFAULT
SMITH SHLDR
SMITH KNEE
2. Press to select a
default setting.
3. Press to conrm
selection and exit.
Or, press to cancel
selection.
Note: User preference settings will not take eect unless a disposable
attachment is connected to the shaver.
EN-18
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System Settings
System settings, such as screen brightness, contrast, and system sound can be
adjusted through the Crossre2 interface.
1. Press and hold .
(Note: If an RF probe is connected to
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-19
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Arthroscopic Shaver Controls
Warning The Crossre2 system is intended for use only by licensed
medical professionals, properly trained in the use of
electrosurgical equipment and techniques. The Crossre2
system generates potentially hazardous levels of energy
that can result in injury or even death if improperly used.
Before using the Crossre2 system in an actual procedure, verify that each
component is installed and functioning properly. Improper connection may
cause arcing or malfunction of the handpiece or console, which can result in
injury, unintended surgical eect, or product damage.
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,
rst 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-20
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Default Handpiece Controls
1
2
3
Default 1 Default 2 /
None
Default 3
1. Oscillate
(one touch)
1
TOUCH
Activate /
Deactivate
Oscillate
(one touch)
1
TOUCH
2. Forward
(one touch)
1
TOUCH
Select Mode:
Oscillate or
Forward /
Reverse
Jog
3. Reverse
(one touch)
1
TOUCH
Forward/
Reverse
Forward
(one touch)
1
TOUCH
Note: Default settings can be selected in the User Preference Settings screen
on the console. Settings will not take eect until a disposable attachment is
connected to the shaver handpiece.
EN-21
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Default Footswitch Controls
The RF and shaver handpieces can also be controlled by the Crossre
Footswitch. The default footswitch controls for the shaver handpiece are
shown below. To customize button assignments, contact your Stryker
representative.
Button Function
Default 1 Default 2 / None Default 3
I Jog Select Mode:
Oscillate or
Forward/Reverse
Select Mode:
Oscillate or
Forward/Reverse
II Select Handpiece:
RF or Shaver
Select Handpiece:
RF or Shaver
Select Handpiece:
RF or Shaver
III Select Direction:
Forward or Reverse
Select Speed:
High or Low
Select Speed:
High or Low
A Oscillate
(xed)
FIXED
Oscillate/Reverse
(variable)
VAR
Oscillate/Reverse
(xed)
FIXED
B Forward/Reverse
(variable)
VAR
Oscillate/Forward
(variable)
VAR
Oscillate/Forward
(xed)
FIXED
EN-22
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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 identication (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.
Note: Forward and reverse settings are adjusted independent of each other.
Adjusting settings in one mode will not aect the other.
EN-23
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Reading the LCD
In shaver mode, the LCD will show:
VAR
F
9000
MC DISP NAME
1 2
3 5
4
1. Footswitch
status
Crossre Footswitch connected
iSWITCH footswitch connected
not connected
2. Footswitch
response
1
TOUCH one touch
(pressing the foot pedal once will activate the
shaver to a default speed; pressing again will stop
it)
FIXED xed
(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 xed; forward/reverse speed is
variable)
3. Direction
F
forward
R
reverse
oscillate
4. Cutter
name
(name)
5. Speed (#) rotations per minute
EN-24
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System Feedback
Event Audible Feedback Visible Feedback
(via LCD)
Reverse activated ve high beeps
R
Forward activated/
resumed
low beep
F
Adjustments made to
speed settings
one beep for each unit
of change
Speed indicator
number increases or
decreases
EN-25
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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,
rst 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.
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
EN-26
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Default footswitch controls
The RF and shaver handpieces can also be controlled by the Crossre
Footswitch. The default footswitch controls for the RF probe are shown below.
To customize button assignments, contact your Stryker representative.
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-27
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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
To adjust COAG power:
1. Press and hold . The COAG POWER
LEVEL screen will appear.
COAG1
COAG2
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 Crossre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-28
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Reading the LCD
In RF ablation mode, the LCD will show:
1
2
3
5
4
11
SERFAS
HC
. . .
6
7
1. Footswitch status Crossre 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
probe name (name)
EN-29
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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
on / o
Single beep
System error Ten short beeps
Adjustments made to
power settings
one beep for each unit
of change
CUT power indicator
number increases or
decreases
Change footswitch to
control RF mode
“SERFAS” “SERFAS” appears
Change footswitch to
control Shaver mode
“Shaver” disposable name
appears
EN-30
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Dual Controls
In arthroscopic procedures, RF probes and arthroscopic shaver handpieces
can be simultaneously connected to the Crossre 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 on the Crossre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 identied 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
identied by handpiece appears on the right side of the LCD.)
EN-31
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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.
F
9000
FIXED
11
SERFAS MC DISP NAME
Dual mode, shaver
handpiece controlled by
footswitch.
F
9000
FIXED 11
SERFASMC DISP NAME
Dual mode, RF probe
controlled by footswitch.
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-32
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Laparoscopy Mode
Indications for Laparoscopic and
General Surgery Use
The Stryker Crossre 2 system is indicated for use in laparoscopic general and
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 t in the jaws of the
instruments.
Contraindications
• The system should not be used with atherosclerotic vessels (calcied
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-33
DRAFT
Setup and Device Connections
Stryker Endoscopy considers instructional training an integral part of the
Crossre2 system. Your Stryker Endoscopy sales representative will perform
at least one inservice at your convenience to help you set up your equipment
and instruct you and your sta on its operation and maintenance. Please
contact your local Stryker Endoscopy representative to schedule an 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 eld.
The Crossre2 System is compatible only with the Stryker handpieces and
footswitches listed in this manual. Do not connect any equipment not
specied in this manual, as unexpected results or serious injury will occur.
EN-34
DRAFT
1. Place the console on a sturdy platform, such as a Stryker cart.
• Select a location according to the recommendations in the preceding
EMC tables.
• Leave four inches of space around all sides for convection cooling.
2. Connect the AC power.
CROSSFIRE II
INTEGRATED RESECTION AND SEALING SYSTEM
3. Connect the handpiece and
footswitch. (Note: Arthroscopic
handpieces are not intended to
be connected during laparoscopic
procedures.)
EN-35
DRAFT
Using the iSWITCH Wireless Footswitch
The Crossre2 system can be used with the iSWITCH Wireless Footswitch
System.
1. Connect the Crossre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 O
Press the power button to power the console on and o. The button will shine
green when the console is on.
EN-36
DRAFT
Warning Should emergency shutdown become necessary, power
o 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
User Preference Settings
User preferences, such as button assignments for the handpiece and
footswitch, can be adjusted through the Crossre2 interface.
Select from the default settings provided with the console, or contact your
Stryker representative to customize your own.
1. Press . DEFAULT
SMITH SHLDR
SMITH KNEE
2. Press to select a
default setting.
3. Press to conrm
selection and exit.
Or, press to cancel
selection.
EN-37
DRAFT
System Settings
System settings, such as screen brightness, contrast, and system sound can be
adjusted through the Crossre2 interface.
1. Press and hold .
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-38
DRAFT
Vessel Sealing Controls
Warning The Crossre2 system is intended for use only by licensed
medical professionals, properly trained in the use of
electrosurgical equipment and techniques. The Crossre2
system generates potentially hazardous levels of energy
that can result in injury or even death if improperly used.
Before using the Crossre2 system in an actual procedure, verify that each
component is installed and functioning properly. Improper connection may
cause arcing or malfunction of the handpiece or console, which can result in
injury, unintended surgical eect, or product damage.
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,
rst 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-39
DRAFT
Default Handpiece Controls
3
2
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-40
DRAFT
Default footswitch controls
The RF and shaver handpieces can also be controlled by the Crossre
Footswitch. The default footswitch controls for the vessel sealing handpiece
are shown below. To customize button assignments, contact your Stryker
representative.
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-41
DRAFT
Reading the LCD
In vessel sealing mode, the LCD will show:
1
6
4
HC
5
3
VESSEL SEALER
SEAL
2 3
1. Progress
indicator indicates progress of vessel sealing
2. Footswitch status Crossre 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
indicator vessel sealing handpiece is connected
EN-42
DRAFT
System Feedback
Event Audible Feedback Visible Feedback
(via LCD)
Sealing activated /
in progress
steady tone SEAL
progress bar
Sealing complete two high beeps SEAL
progress bar
Sealing error alternating high/low
tones
vessel-sealing error
EN-43
DRAFT
Vessel-Sealing Errors
During vessel sealing, the Crossre 2 system will indicate sealing progress.
Should a seal be unsuccessful, the LCD will display an appropriate error
message:
1
2 3
1
2 3
1.
Error Code
2.
Description
Solution
A1 No Vessel Found
Regrasp tissue and retry sealA2 Incomplete Seal
A3 Incomplete Seal
EN-44
DRAFT
Troubleshooting
Problem Possible Solution
Console A hardware fault is
detected
• Turn the power o and on again.
• If the problem persists, contact a
Stryker representative or return
the console for repair.
The AC voltage is
incorrect
• Turn the power off and on again.
• If the problem persists, contact a
Stryker representative or return
the console for repair.
A software fault is
detected
• Turn the power off and on again.
• If the problem persists, contact a
Stryker representative or return
the console for repair.
The system does
not power on
• Check the power cord to ensure it
is properly connected.
• Check to ensure the cord is
connected to a grounded outlet.
The electrical
interference is
sporadic
• Power down all electrical
equipment not in use.
• Increase distance of other
electrical equipment.
• Connect the unit and other
equipment into dierent outlets.
The generator
temperature is too
high
• Ensure that there is proper airow
around the unit.
A power-on self
test error has
occurred
• Turn the power o and on again.
• If the problem persists, contact a
Stryker representative or return
the console for repair.
EN-45
DRAFT
Hand-
piece
The temperature
is higher than
normal
• Allow the unit to cool before
restarting.
The unit has
reached its
recommended
service interval
• Contact your Stryker
representative.
Disposable
Attachments
RF probe is not
ready
• Check the connection to the
console.
RF probe is
expired
• Replace probe.
RF probe
identication is
invalid
• Replace probe.
RF probe
communication
error
• Check the connection to the
console.
• If necessary, replace probe.
Exceeded time
usage
• Replace probe
RF power is too
high
• Check the probe for damage.
• If necessary, replace probe.
RF voltage is too
high
• Check the probe for damage.
• If necessary, replace probe.
RF current is too
high
• Check the probe for damage.
• If necessary, replace probe.
RF delivery
has exceeded
continuous limit
• Clear error and continue
Low impedance
detected
• Check the probe for damage.
• If necessary, replace probe.
Footswitch A wireless
footswitch is not
detected
• Disconnect the wired footswitch.
The footswitch
icon does not
appear
• Ensure the unit is connected.
• Ensure that there is no damage to
the cable or connector.
EN-46
DRAFT
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 Crossre 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:
1
2
1.
Error Code
2.
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-47
DRAFT
Cleaning and Maintenance
Cleaning
Console
Should the console need cleaning, wipe it down with a sterile cloth and mild
cleaning solution. If needed, wipe the console with a disinfectant.
Warning To avoid electric shock and potentially fatal injury,
unplug the Crossre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 Crossre2 console requires no preventative or periodic maintenance.
However, Stryker recommends you reboot the system daily for best
performance.
EN-48
DRAFT
Disposal
This product contains electrical waste or electronic equipment.
It must not be disposed of as unsorted municipal waste and
must be collected separately in accordance with applicable
national or institutional related policies relating to obsolete
electronic equipment.
Dispose of any system accessories according to normal institutional practice
relating to potentially contaminated items.
EN-49
DRAFT
Technical Specications
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 specications. All specications 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 Specications
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 Specications
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-50
DRAFT
Generator Output
Output power at each set point with specied 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
Output Power versus Setting at 200 Ohm Load
0
50
100
150
200
250
300
350
400
Coag
1
Coag
2
Coag
3
1 2 3 4 5 6 7 8 9 10 11
Cut Level
Power (W)
Output Power (CUT) versus Load Resistance
Output Power (Cut) versus Load Resistance
0
50
100
150
200
250
300
350
400
0 100 200 300 400 500 600 700 800 900 1000
Load Resistance (ohms)
(Power (W)
Half Setting Full Setting
EN-51
DRAFT
Output Power (COAG) versus Load Resistance
Output Power (Coag) versus Load Resistance
0
10
20
30
40
50
60
70
80
90
100
0 100 200 300 400 500 600 700 800 900 1000
Load Resistance (Ohms)
Power (W)
Coag 1
Coag 2
Coag 3
Maximum Open Circuit Voltage versus Set Point
Maximum Output Voltage (RMS) versus Setting
0
50
100
150
200
250
300
350
400
Coag
1
Coag
2
Coag
3
1234567891011
Cut Level
Voltage (Vrms)
EN-52
DRAFT
Classications
Warning This equipment is not suitable for use in the presence
of a ammable anesthetic mixture with air, oxygen, or
nitrous oxide.
• Class I equipment
• Type BF applied part
• Degree of protection against harmful ingress of water
• Generator: IEC 60601-2-2: Requirement per clause 44.3
• Probe: IEC 60601-2-2: Requirement per clause 44.6
• Footswitch: IEC 60601-2-2: Requirement per clause 44.6,
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: Crossre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 modications 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
Eective radiated power: 50μW
EN-53
DRAFT
Industry Canada (IC)
IC: 4919C-XFC2
Trade Name: Crossre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 certication number only signies that
Industry Canada technical specications were met.
EN-54
DRAFT
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
Declare under our sole responsibility that the product:
Product name: Crossre2 Integrated Arthroscopy System
Trade Name: Crossre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).
e 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
Notied body involved: TÜV Rheinland Product Safety
(GmbH)
Technical le 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. Jerey Semone
Title: Director, Regulatory Aairs
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-55
DRAFT
Electromagnetic Compatibility
Like other electrical medical equipment, the Crossre2 System requires
special precautions to ensure electromagnetic compatibility with other
electrical medical devices. To ensure electromagnetic compatibility (EMC),
the Crossre2 System must be installed and operated according to the EMC
information provided in this manual.
The Crossre2 System has been designed and tested to comply with IEC
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 aect the normal
function of the Crossre2 System even if such equipment meets the
applicable emissions requirements.
Do not use cables or accessories other than those provided with the
Crossre2 System, as this may result in increased electromagnetic emissions
or decreased immunity to such emissions.
If the Crossre2 System is used adjacent to or stacked with other
equipment, observe and verify normal operation of the Crossre2 System
in the conguration 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 Crossre2 System.
EN-56
DRAFT
When the Crossre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
shutdown and disconnection from the power source. Do not position the
console in a way that is dicult to disconnect the AC power cord.
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The Crossre2 System is intended for use in the electromagnetic environment specied below. The
customer or the user of Crossre2 System should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions CISPR11 Group 1 The Crossre2 System must emit
electromagnetic energy in order to
perform its intended function. Nearby
electronic equipment may be aected.
RF emissions CISPR11 Class A Crossre2 System is suitable for use in all
establishments other than domestic and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic emissions IEC 61000-
3-2
Class A
Voltage Fluctuations/icker
emissions IEC 61000-3-3
Complies
EN-57
DRAFT
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The Crossre2 System is intended for use in the electromagnetic environment specied below. The
customer or the user of Crossre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) IEC
61000-4-2
±6kV contact
±8kV air
±2,4,6kV contact ±2,4,8kV
air
Floors should be wood,
concrete, or ceramic tile.
If oors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst IEC
61000-4-4
±2kV for power supply
lines ±1kV for input/
output lines
±2kV for power supply
lines ±1kV for input/
output lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV dierential mode
±2kV common mode
±0.5, 1kV dierential
mode ±1, 2kV common
mode
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines IEC
61000-4-11
<5% Ut (>95% dip in Ut)
for 0.5 cycle
40% Ut (60% dip in Ut) for
5 cycles
70% Ut (30% dip in Ut) for
25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec.
<5% Ut (>95% dip in Ut)
for 0.5 cycle
40% Ut (60% dip in Ut)
for 5 cycles
70% Ut (30% dip in Ut) for
25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec.
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of Crossre2 System
requires continued
operation during power
mains interruptions,
it is recommended
that Crossre2 System
be powered from an
uninterruptible power
supply or a battery.
Power frequency
(50/60Hz) magnetic
eld IEC 61000-4-8
3 A/m N/A Power-frequency
magnetic elds 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.
EN-58
DRAFT
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
Crossre2 System is intended for use in the electromagnetic environment specied below. The customer or
the user of Crossre2 System should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level
Compliance Level Electromagnetic Environment: Guid-
ance
Portable and mobile RF communications
equipment should be used no
closer to any part of the Crossre2
system, including its cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended Separation Distance d
= 1.17 √P
Conducted RF
IEC 61000-4-6
3 Vrms 150 kHz to
80 MHz
3 V d = 1.17 √P
80 MHz to 800 MHz
Radiated RF IEC
61000-4-3
3 V/m
80MHz to 2.5 GHz
3 V/m d = 2.33 √P
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 xed 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 aected by
absorption and reection from structures, objects, and people.
(a) Field strengths from xed 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 xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which the
Crossre2 System is used exceeds the applicable RF compliance level above, the Crossre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 Crossre2 System.
(b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
EN-59
DRAFT
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment
and the Crossre2 System
The Crossre2 System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the Crossre2 System can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Crossre2 System as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum
output power (W) of
transmitter
Separation distance (m) according to frequency 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 1.17 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 aected by absorption and reection
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
dened below.
Warning Symbols
Warning/Caution:
See instructions for
use
Hazardous voltage present
Front Console Symbols
Power Select
Up Down
EN-60
DRAFT
MENU Menu Footswitch
Probe Shaver handpiece
Directed energy
handpiece
Rear Console Symbols
Equipotentiality USB
Stryker rewire Emits RF radiation
Type CF rated Protective ground earth
Fuse rating Compliant to CSA C22.2 No.
601.1-M90, and UL 601-1
Fullls requirements
of the European
Medical Device
Directive 93/42/EEC
LCD Symbols
Electrosurgical unit Contrast
Brightness Sound
EN-61
DRAFT
Packaging/Labeling Symbols
Legal manufacturer Authorized representative in
Europe
Date of manufacture Atmospheric pressure range
Ambient
temperature range Relative humidity 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-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 dra 2
2011/10
DRAFT

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