Stryker Crossfire User Manual Download Page 42

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EN-40

Classifications

Warning This equipment is not suitable for use in the presence of a

flammable anesthetic mixture with air, oxygen, or nitrous

oxide.

• Class I equipment

• Type BF applied part

• Degree of protection against harmful ingress of water

• Generator: IPX0

• Probe: IPX0

• Footswitch: IPX7 Water-tight Equipment

Federal Communications Commission (FCC)

FCC ID: SSH-XFC

Trade Name:

Crossfire™ Console

Type or Model:

0475000000

This device complies with Part 15 of the FCC rules. Operation is subject to the

following two conditions:

1. This device may not cause harmful interference, and
2. This device must accept any interference received, including

interference that may cause undesired operation.

Note:

FCC regulations provide that changes or modifications not expressly

approved by Stryker Endoscopy could void your authority to operate this

equipment.

Frequency of transmission:

13.56MHz

Type of frequency / characteristics of the modulation:

10% ASK

Subcarrier:

423.75kHz, Manchester coding

Effective radiated power:

50μW

Summary of Contents for Crossfire

Page 1: ...Crossfire Console REF 0475000000 User Guide ...

Page 2: ......

Page 3: ... the Console On and Off 18 Operation 19 The Crossfire 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 S...

Page 4: ......

Page 5: ...detailed in this operating manual Refer any readjustments modifications and or repairs to Stryker Endoscopy or its authorized representatives 3 Pay close attention to the care and cleaning instructions in this manual Failure to follow these instructions may result in product damage 4 Install this device in an operating room that complies with all applicable IEC CEC and NEC requirements for safety ...

Page 6: ...s 2 The operator of the Crossfire system should be experienced in arthroscopic and electrosurgical practices and techniques 3 The operator of the Crossfire system should read this manual thoroughly and be familiar with its contents prior to operating the equipment 4 The operator of the Crossfire system should be sure that the system functions as outlined in this manual prior to a surgical procedur...

Page 7: ...le frame or instrument table to prevent risk of shock The use of antistatic sheeting is recommended for this purpose 3 DO NOT activate the Crossfire system for prolonged lengths of time when the attachment is not in contact with tissue Doing so may lead to unintentional damage to surrounding tissue 4 When the Crossfire system is activated the conducted and radiated electrical fields may interfere ...

Page 8: ...esult 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 flammable agents for cleaning and disinfection of the Crossfi...

Page 9: ...e various components of the Crossfire system Powers a motorized shaver handpiece for the mechanical cutting and debridement of bone and soft tissue Generates bipolar radio frequency RF energy for the electrosurgical cutting and coagulation of tissue Provides a central user interface for operating the Crossfire system 2 Disposable RF probe Enables RF cutting and coagulation 3 Powered shaver handpie...

Page 10: ...or other electronic implants Package Contents Carefully unpack the Crossfire console and inspect each of the following components Report any damaged components to Stryker 1 Crossfire console 1 Hospital grade power cord 0105 003 001 1 User guide Available Accessories The Crossfire system is compatible with the following accessories 0475 000 100 Crossfire Footswitch 0279 xxx xxx SERFAS Energy family...

Page 11: ...djusting 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 off 6 Error indicator Shines red to indicate errors error details appear in the LCD 7 LCD screen Provides syst...

Page 12: ... 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 ...

Page 13: ...lled and operated according to the EMC information provided in this manual The Crossfire System has been designed and tested to comply with IEC 60601 1 2 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 mitigati...

Page 14: ...on from the power source Do not position the console in a way that is difficult to disconnect the AC power cord Guidance and Manufacturer s Declaration Electromagnetic Emissions The Crossfire System is intended for use in the electromagnetic environment specified below The customer or the user of Crossfire System should ensure that it is used in such an environment Emissions Test Compliance Electr...

Page 15: ...ial 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 ...

Page 16: ...nsmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection...

Page 17: ...itter 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 ...

Page 18: ...al grade power cables Using other cables may result in increased RF emissions or decreased immunity from such emissions Only the handpieces and disposable attachments are suitable for use in the patient environment The console and footswitch are not sterile devices and should not enter the sterile field The Crossfire System is compatible only with the Stryker handpieces and footswitches listed in ...

Page 19: ...rt 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 ...

Page 20: ...e on and off The button will shine green when the console is on Warning Should emergency shutdown become necessary power off the console as described above As an added safety measure the console can be separated from the AC power mains by detaching the AC power cord from either end ...

Page 21: ...erly trained in the use of electrosurgical equipment and techniques The Crossfire system generates potentially hazardous levels of energy that can result in injury or even death if improperly used Before using the Crossfire 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 w...

Page 22: ...tatus error codes mode of operation cutting speed and power levels Reading the LCD Screen 3 Select The Select button toggles between RF and Shaver controls The selected device can then be controlled using the Crossfire interface Selecting Between RF and Shaver Modes 4 Adjust The Adjust buttons increase decrease speed and power settings for the selected device Adjusting Power and Speed Settings ...

Page 23: ...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 confirm selection and exit Or press to cancel selection Note User preference settings will not take effect unless a disposable attachment is connected to the shaver Note When using small joint handpieces system defaults will take effect...

Page 24: ...ness contrast and system sound can be adjusted through the Crossfire interface 1 Press and hold 2 Press to choose contrast brightness or sound 3 Press to adjust 4 Press and hold to exit Note A short press will display the current version of the console software ...

Page 25: ...rrent status RF Mode In RF mode the LCD will show 11 SERFAS 1 2 3 5 4 1 Footswitch status Crossfire footswitch connected iSwitch footswitch connected not connected 2 Mode cut mode coagulation mode 3 Force modulation force modulation activated force modulation not activated 4 Probe name name 5 Power power setting ...

Page 26: ...ne touch pressing the shaver button once will activate the shaver to a default speed pressing again will stop it FIXED fixed pressing the shaver button at any pressure will result in a constant speed VAR variable for small joint handpieces shaver speed will vary depending on the pressure applied to the shaver button 3 Direction F forward R reverse oscillate 4 Cutter name name 5 Speed rotations per...

Page 27: ... to the right except during adjustments to RF settings To select between RF and shaver modes press F 9000 FIXED 11 SERFAS MC DISP NAME Dual mode normal screen F 9000 FIXED 11 SERFAS MC DISP NAME Dual mode adjustments being made to RF power settings The screen will revert to normal after 5 seconds of inactivity ...

Page 28: ...mer 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 Adjusting Power and Speed Settings Use the buttons on the console to manually adjust the power or speed setting for the active handpiece Note Forward and re...

Page 29: ...se RF handpieces are intended for single use only and should not be reprocessed or reused 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 Each handpiece has its own set of controls RF Hand Controls 1 2 3 1 Adjust CUT power level single press or Activate deactivate Force Modula...

Page 30: ...s can also be controlled by the Crossfire Footswitch The default footswitch controls are shown below To customize button assignments contact your Stryker representative Note For more detailed information on the Crossfire Footswitch consult the Crossfire Footswitch User Guide English 1000 401 032 International P11345 Note To keep the footswitch clean during use Stryker recommends using disposable b...

Page 31: ...EN 29 Default RF Controls 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 ...

Page 32: ...piece 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 fixed Oscillate Reverse variable Oscillate Reverse fixed B Forward Reverse variable Oscillate Forward variable Oscillate Forward fixed Note When using small joint handpieces only Default 2 settings are available No other defaults or user preferences...

Page 33: ...e used with the iSWITCH Wireless Footswitch System 1 Connect the Crossfire 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 ...

Page 34: ...e beep Disposable attachment connected Single beep Footswitch detected Single beep RF probe detected Single beep During use RF COAG mode active Continuous tone low RF CUT mode active Continuous tone high System error Three beeps Force modulation on off Single beep Shaver reverse mode activated Five short beeps Toggle from footswitch between RF and Shaver The console will say Shaver or SERFAS ...

Page 35: ...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 different outlets The generator temperature is too high Ensure that there is proper airflow around the unit ...

Page 36: ...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 detected Disconnect the wired footswitch The footswitch icon does not appear Ensure the unit is...

Page 37: ...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 attachmen...

Page 38: ...ed 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 ...

Page 39: ...ges and new products Dimensions Size 16 9 L 12 5 H 4 5 W Weight 20 lbs Environmental Specifications Operating temperature 5 40 C Operating humidity 30 95 RH Shipping temperature 18 60 C Shipping humidity 15 90 RH System Input Power Requirements Voltage 100 240 VAC 50 60Hz 6 10 A Inlet Fuse F 16 0AH 250V Electrical Specifications Motor output max speed 12000 RPM Motor duty cycle Continuous operatio...

Page 40: ...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 ...

Page 41: ...0 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 1 2 3 4 5 6 7 8 9 10 11 Cut Level Voltage Vrms ...

Page 42: ...Model 0475000000 This device complies with Part 15 of the FCC rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 This device must accept any interference received including interference that may cause undesired operation Note FCC regulations provide that changes or modifications not expressly approved by Stryker Endoscopy could void yo...

Page 43: ...t to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device The term IC before the radio certification number only signifies that Industry Canada technical specifications were met ...

Page 44: ...ined below Warning Symbols Indicates risks to the safety of the patient or user Failure to follow warnings may result in injury to the patient or user Warning Caution See instructions for use Hazardous voltage present Front Console Symbols Power Select Up Down MENU Menu Footswitch Probe Handpiece Rear Console Symbols Equipotentiality USB Stryker firewire Emits RF radiation ...

Page 45: ...trast Brightness Sound Packaging Labeling Symbols Legal manufacturer Fragile Date of manufacture Atmospheric pressure range Ambient temperature range Relative humidity range LOT Lot number Product number SN Serial number This product contains electrical waste or electronic equipment It must not be disposed of as unsorted municipal waste and must be collected separately ...

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Page 48: ...Stryker Endoscopy 5900 Optical Court San Jose CA 95138 USA 1 408 754 2000 1 800 624 4422 www stryker com 1000 401 036 Rev J 2014 01 ...

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