Stryker Endoscopy XFC2 User Manual
DRAFT
Crossfire™ 2
REF 0475100000
Contents
Warnings and Cautions .....................................................................3
Product Description/Intended Use ................................................ 7
Package Contents ................................................................................ 8
Available Accessories ........................................................................... 8
The Crossre2 Console ........................................................................9
The Crossre2 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 Specications .................................................................. 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
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.
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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 specically detailed in this
operating manual. Refer any readjustments, modications, 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 Crossre2 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-3
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 Crossre2 system should be a qualied 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 Crossre2 system should be experienced in
arthroscopic and electrosurgical practices and techniques.
3. The operator of the Crossre2 system should read this manual
thoroughly and be familiar with its contents prior to operating the
equipment.
4. The operator of the Crossre2 system should be sure that the system
functions as outlined in this manual prior to a surgical procedure. The
Crossre2 system was fully tested at the factory before shipment.
5. Crossre2 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
Crossre2 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 Crossre2 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
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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 Crossre2 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 Crossre2 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 Crossre2 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 Crossre2 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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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
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
Crossre2 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 specied otherwise in
this manual. Units requiring repair should be returned to Stryker.
5. Disconnect the Crossre2 system from the electrical output when
inspecting fuses.
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EN-6
Product Description/Intended Use
The Crossre2 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 Crossre2 system consists of the following components:
1
2
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3
5
4
1. Crossre2 Console (featured in this manual)
• Acts as a connection hub for the various components of the Crossre2
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 Crossre2 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. Crossre Footswitch
Provides remote, foot control of the powered shaver handpiece and RF
probe
EN-7
Package Contents
Carefully unpack the Crossre2 console and inspect each of the following
components. Report any damaged components to Stryker.
(1) Crossre2 console
(1) Hospital-grade power cord
(1) User guide
Available Accessories
The Crossre2 system is compatible with the following accessories:
System Accessories
0475-000-100 Crossre 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
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Laparoscopy Accessories
0250-080-800 35 cm Crosseal Vessel Sealing Handpiece
0250-080-850 45 cm Crosseal Vessel Sealing Handpiece
EN-8
The Crossre2 Console
The Crossre2 console is the connection hub for the components of the
Crossre2 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.
1 2
3 4
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5 6 7 8 9
1. Menu Selects menu items
2. Select Selects which device displays on
the LCD screen.
3. RF connector
(SERFAS Energy and
Crosseal Handpieces)
4. Handpiece connector Powered shaver handpiece
5. Power Powers the console on and o
Delivers RF energy for ablation or
vessel sealing handpieces
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 Crossre Footswitch
EN-9
Rear Panel
The rear panel provides ports for connecting the console to other Stryker
equipment.
1 2 3 4
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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 Crossre2 Interface
The Crossre2 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 Crossre Footswitch.
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1 4 52 3
Control Description
1. Menu The Menu button opens a menu for selecting user and
system settings.
2. Error
indicator
3. LCD screen The LCD screen displays system status, error codes, mode
4. Select The Select button toggles between RF and Shaver
5. Adjust The Adjust buttons increase/decrease speed and power
The Error indicator shines red when a system error
occurs.
of operation, cutting speed, and power levels.
controls. The selected device can then be controlled
using the Crossre2 interface.
settings for the selected device.
EN-11
Arthroscopy Mode
Indications for Arthroscopic Use
The Stryker Crossre 2 system is indicated for use in orthopedic and
arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow,
wrist, and hip. The crossre 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.
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EN-12
Setup and Device Connections
Stryker Endoscopy considers instructional training an integral part of the
Crossre2 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 Crossre2 System is compatible only with the Stryker handpieces and
footswitches listed in this manual. Do not connect any equipment not
specied in this manual, as unexpected results or serious injury will occur.
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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.
2. Connect the AC power.
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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:
EN-14
4. Connect suction tubing (for all
suction-capable devices).
Using the iSWITCH Wireless Footswitch
The Crossre2 system can be used with the iSWITCH Wireless Footswitch
System.
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1. Connect the Crossre2 console to the iSWITCH console using one of
the Firewire connection ports on each console.
2. Consult the iSWITCH Operating and Maintenance Manual (P/N1000400-700) for further operation instructions.
EN-15
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.
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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-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 Crossre2
interface.
Select from the default settings provided with the console, or contact your
Stryker representative to customize your own.
1. Press
2. Press
default setting.
3. Press to conrm
selection and exit.
Or, press
selection.
Note: User preference settings will not take eect unless a disposable
attachment is connected to the shaver.
.
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to select a
to cancel
DEFAULT
SMITH KNEE
SMITH SHLDR
EN-17
System Settings
System settings, such as screen brightness, contrast, and system sound can be
adjusted through the Crossre2 interface.
1. Press and hold .
(Note: If an RF probe is connected to
the console, the COAG adjustment
screen will appear. Press
access the system settings screen.)
2. Press to choose (contrast),
3. Press
4. Press and hold to exit.
(Note: A short press will display the current version of the console
software.)
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will indicate your selection.)
to adjust.
again to
(brightness), or (sound). (The
EN-18
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