Stryker 7205-000-000, Instructions For Use Manual

Page 1: ...2018 11 7205 001 700 Rev AA www stryker com Instructions For Use ENGLISH EN System 7 Dual Trigger Rotary Handpiece REF 7205 000 000 ...

Page 2: ...s Instructions For Use manual is the most comprehensive source of information for the safe and effective use of your product This manual may be used by in service trainers physicians nurses surgical technologists and biomedical equipment technicians Keep and consult this reference manual during the life of the product The following conventions are used in this manual A WARNING highlights a safety ...

Page 3: ... WARNINGS Use only Stryker approved system components and accessories unless otherwise specified DO NOT modify any system component or accessory Using other electronic components and accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system DO NOT reuse reprocess or repackage a device that is intended for single use only A single use device m...

Page 4: ... 000 Stryker SmartLife Non sterile Battery Large 7126 110 000 Stryker SmartLife Aseptic Housing Large 7126 120 000 Stryker SmartLife Transfer Shield Large 7126 130 000 Stryker SmartLife Non sterile Battery Small 7222 110 000 Stryker SmartLife Aseptic Housing Small 7222 120 000 Stryker SmartLife Transfer Shield Small 7222 130 000 Features Handpiece A G F C B E D A Function Switch Locks one or both ...

Page 5: ...able speed operation of the handpiece in a clockwise direction NOTE Press both triggers simultaneously to operate the handpiece in oscillate mode Function Switch Forward Mode Only the forward trigger is functional The reverse trigger is locked to prevent inadvertent operation of the handpiece in a counterclockwise direction Forward Reverse Oscillate Mode Both triggers are functional Safe Mode Both...

Page 6: ...e Specifications section General warning sign To comply with European Community Waste Electrical and Electronic Equipment WEEE Directive 2012 19 EU ALWAYS collect this product separately for recycling DO NOT dispose of this product as unsorted municipal waste Contact your local distributor for disposal information Direct current Instructions To Install the Attachment and Accessory WARNING ALWAYS s...

Page 7: ...ons for use supplied with the battery pack and or battery charger for charging instructions and specifications 1 Slide a fully charged battery pack into the handpiece until the battery pack snaps into place 2 Gently tug the battery pack to make sure the battery pack is securely locked in the handpiece 3 Test the operation of the handpiece by sliding the function switch to the forward or forward re...

Page 8: ...ontinued WARNINGS DO NOT operate the handpiece in the drill mode position when a reamer attachment and or accessory is installed in the handpiece Before operating the handpiece ALWAYS gently tug the attachment and accessory to make sure the attachment is securely locked in the handpiece and the accessory is securely locked in the attachment DO NOT change the position of the shift collar while the ...

Page 9: ...f the handpiece To Remove the Attachment and Accessory WARNING ALWAYS slide the function switch to the safe mode position before removing the attachment or accessory 1 Remove the accessory from the attachment 2 Pull the attachment collar back and remove the attachment from the handpiece Care Instructions For processing instructions and disposal recycle information see the care instructions manual ...

Page 10: ...ly installed in the handpiece Remove and install the attachment Make sure the attachment is securely locked in the handpiece The shift collar is positioned between the drill and ream mode positions Fully rotate the shift collar to either the drill mode or ream mode position Excessive pressure is being applied to the cutting accessory Release the pressure and allow the cutting accessory to do the c...

Page 11: ...nstall a different accessory or attachment as required The accessory extends too far from the distal end of the attachment or is not properly centered in the attachment Remove and properly install the accessory If wobble persists return the handpiece and attachment to Stryker for repair A reamer attachment and or accessory is installed in the handpiece and the shift collar is in the drill mode pos...

Page 12: ...0 000 Dimensions 153 mm 6 1 inch height 38 mm 1 5 inch width 153 mm 6 1 inch length Mass 0 99 kg 2 2 lb Speed 1200 rpm drill 270 rpm ream Forward and Reverse Modes Oscillate Mode Mode of Operation Non continuous Operation Non continuous Operation Duty Cycle 1 minute on 4 minutes off 3 times 15 seconds on 15 seconds off 5 times Rest Between Cycles 3 hours 1 5 hours Maximum Temperature of Applied Pa...

Page 13: ...ty and Essential Performance Consolidated Reprint 2009 R 2012 Amendment 2 2010 R 2012 Amendment 1 2012 Product Safety Compliance International Electrotechnical Commission IEC IEC 60601 1 2005 Ed 3 1 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Corrigendum 1 2006 Corrigendum 2 2007 Amendment 1 2012 European Committee for Electrotechnical Standa...

Page 14: ...4 www stryker com EN 7205 001 700 Rev AA Specifications continued Environmental Conditions Operation Storage and Transportation Temperature Limitation Humidity Limitation Atmospheric Pressure Limitation ...

Page 15: ... and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The System 7 Dual Trigger Rotary Handpiece REF 7205 000 000 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning...

Page 16: ...hanged due to 60601 1 2 4th Edition requirements Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air 8 kV contact 2 kV 4 kV 8 kV 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electri...

Page 17: ...t 0 45 90 135 180 225 270 and 315 0 UT 100 dip in UT for 1 cycle at 0 70 UT 30 dip in UT for 25 and 30 cycles at 0 5 UT 95 dip in UT for 5 seconds 0 UT 100 dip in UT for 250 300 cycles N A N A Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 30 A m at 50 and 60 Hz 3 A m 30 A m at 50 and 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a t...

Page 18: ...F equipment should be used no closer to any part of the System 7 Dual Trigger Rotary Handpiece REF 7205 000 000 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watt...

Page 19: ... compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Non ionizing electromagnetic radiation NOTE 1 At 80 MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field s...

Page 20: ...mended below according to the maximum output power of the equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz N A 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 N A 0 12 0 23 0 1 N A 0 38 0 73 1 N A 1 2 2 3 10 N A 3 8 7 3 100 N A 12 23 For transmitters rated at a maximum output power not listed above the rec...

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Page 24: ... 700 Rev AA www stryker com Stryker Instruments 4100 E Milham Kalamazoo Michigan USA 49001 1 269 323 7700 1 800 253 3210 ES DE FR IT NL 7205 001 710 JA ZH KO 7205 001 720 SV DA FI PT NO 7205 001 730 PL EL 7205 001 750 ...