Stryker Crossfire User manual

Crossfire™ Console
REF 0475000000
User Guide

EN-1
Contents
Warnings and Cautions..............................................................3
Product Description and Intended Use............................7
Indications/Contraindications ............................................................8
Package Contents .............................................................................8
Available Accessories ........................................................................8
The Crossre™ Console....................................................................9
Setup and Interconnection....................................................11
Electromagnetic Compatibility.........................................................11
Connections.....................................................................................16
Powering the Console On and Off ...................................................18
Operation .........................................................................................19
The Crossre™ Interface .................................................................20
Adjusting User and System Settings ...............................................21
Reading the LCD Screen .................................................................23
Selecting Between RF and Shaver Modes ......................................26
Selecting Force Modulation in RF Mode .........................................26
Adjusting Power and Speed Settings ..............................................26
Using the Handpiece .......................................................................27
Using the Footswitch .......................................................................28
Audible Feedback ............................................................................32
Troubleshooting ...........................................................................33
Cleaning and Maintenance....................................................35
Cleaning...........................................................................................35
Disposal ...........................................................................................36
Technical Specifications.........................................................37
Generator Output.............................................................................37
Symbols and Definitions .........................................................42

EN-3
Warnings and Cautions
Please read this manual and follow its instructions carefully. e 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. e warranty is void if
any of these warnings is disregarded.
1. 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™ 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 (NO) atmospheres, or in the presence of other oxidizing agents,
to prevent risk of explosion. Ensure that oxygen connections are not
leaking.

EN-4
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.
5. Flammable agents used for cleaning or disinfecting, or as solvents of
adhesives, should be allowed to evaporate before using the Crossre™
system. ere is a risk of pooling of ammable solutions under the
patient or in body depressions such as the umbilicus, and in body
cavities such as the vagina. Any uid pooled in these areas should be
mopped up before Crossre™ system is used. Attention should be called
to the danger of ignition of endogenous gases. Some materials, for
example cotton and gauze, when saturated with oxygen may be ignited
by sparks produced in normal use of the Crossre™ system.
Prior to Surgery
1. e operator of the Crossre™ 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 electrosurgical procedures.
2. e operator of the Crossre™ system should be experienced in
arthroscopic and electrosurgical practices and techniques.
3. e operator of the Crossre™ system should read this manual
thoroughly and be familiar with its contents prior to operating the
equipment.
4. e operator of the Crossre™ system should be sure that the system
functions as outlined in this manual prior to a surgical procedure. e
Crossre™ system was fully tested at the factory before shipment.
5. Crossre™ 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™ 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

EN-5
current.
10. Position the console so the fan directs the ow of air away from the
patient.
11. When the Crossre™ system and physiological monitoring equipment
are used simultaneously on a patient, position any monitoring electrodes
as far as possible from the surgical electrodes. Monitoring equipment
using high frequency, current-limiting devices is recommended. Needle
monitoring electrodes are NOT recommended.
12. Smoke generated during electrosurgical procedures may be harmful to
surgical personnel. Take appropriate precautions by wearing surgical
masks or other means of protection.
13. Neuromuscular stimulation may occur when RF probes are used.
During Surgery
1. DO NOT use the Crossre™ 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.
e use of antistatic sheeting is recommended for this purpose.
3. DO NOT activate the Crossre™ 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™ 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™ system until the probe is properly
positioned in the patient.

EN-6
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. e 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.
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™ 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™ system from the electrical output when
inspecting fuses.

EN-7
Product Description and Intended Use
e Crossre™ Integrated Arthroscopy System is a combination powered
shaver system/electrosurgical generator, intended for use in arthroscopic and
orthopedic procedures.
Illustrated below, the Crossre™ system consists of the following components:
2
1
3
4
1. Crossre™ Console
(featured in this
manual)
• Actsasaconnectionhubforthevarious
components of the Crossre™ system
• Powersamotorizedshaverhandpiecefor
the mechanical cutting and debridement of
bone and so tissue
• Generatesbipolarradiofrequency(RF)
energy for the electrosurgical cutting and
coagulation of tissue
• Providesacentraluserinterfacefor
operating the Crossre™ system
2. Disposable RF probe Enables RF cutting and coagulation
3. Powered shaver
handpiece (and
disposable attachments)
Enables arthroscopic cutting and debridement
4. Crossre™ Footswitch Provides remote, foot control of the powered
shaver handpiece and RF probe

EN-8
Indications/Contraindications
e Crossre™ system is indicated for use in orthopedic and arthroscopic
procedures for the knee, shoulder, ankle, elbow, wrist, and hip. e Crossre™
System provides abrasion, resection, debridement, and removal of bone and so
tissue through its shaver blade, and the ablation and coagulation of so tissue, as
well as hemostasis of blood vessels, through its electrosurgical probe.
Examples of uses of the product include resection, ablation, and coagulation of
torn knee cartilage, subacromial decompression, and resection of synovial tissue
in other joints.
e electrosurgical probe is contraindicated for use in procedures where a
nonconductive irrigant is used or with patients having cardiac pacemakers or
other electronic implants.
Package Contents
Carefully unpack the Crossre™ console and inspect each of the following
components. Report any damaged components to Stryker.
(1) Crossre™ console
(1) Hospital-grade power cord (0105-003-001)
(1) User guide
Available Accessories
e Crossre™ system is compatible with the following accessories:
0475-000-100 Crossre™ Footswitch
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
0277-200-100 iSWITCH™ Universal Wireless Footswitch Receiver
0277-100-100 iSWITCH™ Universal Wireless Footswitch
6000-001-020 Stryker rewire cable
Note: Instructions for use can be found in the following manuals:
Crossre™ Console: 1000-401-036 (English) or P11344 (international)
Crossre™ Footswitch: 1000-401-032 (English) or P11345 (international)

EN-9
The Crossfire™ Console
e Crossre™ console is the connection hub for the components of the
Crossre™ system. It generates RF energy, powers motorized shavers, and
provides user controls and system feedback.
Front Panel
e front console panel features ports for connecting handpieces, controls for
adjusting handpiece settings, and an LCD screen to provide system feedback.
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 probe
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

EN-10
Rear Panel
e 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 uploading of preset user
settings
3. Equipotential
Ground Plug
—
4. AC Power Inlet —

EN-11
Setup and Interconnection
Stryker Endoscopy considers instructional training an integral part of the
Crossre™ 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 aer your
equipment has arrived.
Electromagnetic Compatibility
Like other electrical medical equipment, the Crossre™ System requires special
precautions to ensure electromagnetic compatibility with other electrical medical
devices. To ensure electromagnetic compatibility (EMC), the Crossre™ System
must be installed and operated according to the EMC information provided in
this manual.
e Crossre™ System has been designed and tested to comply with IEC 60601-
1-2 requirements for EMC with other devices.
Warning is equipment is intended for use by health care
professionals only. is 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™ System
even if such equipment meets the applicable emissions
requirements.
e Crossre™ System was not tested for immunity to
electromagnetic disturbances.
Do not use cables or accessories other than those provided
with the Crossre™ System, as this may result in increased
electromagnetic emissions or decreased immunity to such
emissions.

EN-12
If the Crossre™ System is used adjacent to or stacked with
other equipment, observe and verify normal operation
of the Crossre™ 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™ System.
When the Crossre™ System is interconnected with other
medical electrical equipment, leakage currents may be
additive. To minimize total patient leakage current, any
Type BF applied part should be used together with other
Type BF applied parts. Ensure all systems are installed
according to the requirements of IEC 60601-1-1.
e 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™ System is intended for use in the electromagnetic environment specied below. The
customer or the user of Crossre™ 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™ System must emit
electromagnetic energy in order to
perform its intended function. Nearby
electronic equipment may be affected.
RF emissions CISPR11 Class A Crossre™ 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-13
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The Crossre™ System is intended for use in the electromagnetic environment specied below. The
customer or the user of Crossre™ System should ensure that it is used in such an environment
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
Environment: Guid-
ance
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 differential mode
±2kV common mode
±0.5, 1kV differential
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™
System requires
continued operation
during power mains
interruptions, it is
recommended that
Crossre™ 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-14
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
Crossre™ System is intended for use in the electromagnetic environment specied below. The
customer or the user of Crossre™ System should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level
Compliance Level Electromagnetic Environment:
Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of
the Crossre™ 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 affected 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™ System is used exceeds the applicable RF
compliance level above, the Crossre™ 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™ System.
(b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

EN-15
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the Crossre™ System
The Crossre™ System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the Crossre™ System can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Crossre™ 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 affected by absorption and
reection from structures, objects, and people.

EN-16
Connections
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. e console and footswitch are not sterile devices and
should not enter the sterile eld.
e Crossre™ 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-17
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.
3. Connect the handpieces and
footswitch.
4. Connect suction tubing (for all
suction-capable devices).

EN-18
Powering the Console On and Off
Press the power button to power the console on and o. e 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.