Stryker System 6 6203-000-000 Instructions For Use Manual Download Page 12

Page: 12 / 17

6203-001-700 Rev-E

www.stryker.com

Product
Safety
Certification:

CSA International

International Electrotechnical Commission

IEC 60601-1:2005,

Medical Electrical Equipment — Part 1: General Requirements for Basic

Safety and Essential Performance

; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007)

IEC 60601-1:1988,

Medical Electrical Equipment — Part 1: General Requirements for Safety -

Second Edition

; Amendment 1 (1991); Amendment 2 (1995); Corrigendum 1 (1995)

Canadian Standards Association

CAN/CSA-C22.2 No. 60601-1:08,

Medical Electrical Equipment — Part 1: General

Requirements for Basic Safety and Essential Performance

CAN/CSA-C22.2 No. 601.1-M90,

Medical Electrical Equipment — Part 1: General Requirements

for Safety

American National Standards Institute / Association for the Advancement of Medical
Instrumentation

ANSI/AAMI ES60601-1:2005,

Medical Electrical Equipment — Part 1: General Requirements

for Basic Safety and Essential Performance

; Consolidated Reprint (2009); Amendment 2

(2010)

Underwriters Laboratories

UL 60601-1,

Medical Electrical Equipment, Part 1: General Requirements for Safety — First

Edition

; Revisions through and including April 26, 2006

European Committee for Electrotechnical Standardization (CENELEC)

EN 60601-1:2006,

Medical Electrical Equipment — Part 1: General Requirements for Basic

Safety and Essential Performance

; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007);

CENELEC Corrigendum (2010)

Summary of Contents for System 6 6203-000-000

Page 1: ...n of the document should not appear on produced Labels or IFUs Description Type Stryker Instruments 269 323 7700 800 253 3210 Print Location Suppliers Services Part Number Rev 6 inch width x 6 inch Booklet Print Center Color Graphics on White Background 20 Bond or Equivalent N A N A Instructions For Use 6203 001 700 E ...

Page 2: ...2015 03 6203 001 700 Rev E www stryker com System 6 Single Trigger Rotary Handpiece 6203 000 000 Instructions For Use ENGLISH EN ...

Page 3: ... used with a variety of attachments is intended for surgical procedures involving drilling reaming driving wire or pins cutting bone and hard tissue Contraindications None known User Patient Safety WARNINGS Only trained and experienced healthcare professionals should use this equipment Before using any system component or any component compatible with this system read and understand the instructio...

Page 4: ...mponents and accessories unless otherwise specified Using other accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system DO NOT modify any system component or accessory DO NOT reuse reprocess or repackage single use cutting accessories All cutting accessories are intended for a single use only Reuse may create a serious risk of contamination...

Page 5: ...achment slide the actuating collar Shifter Knob To select the handpiece mode of REAM slow or DRILL fast rotate the knob to the appropriate position as required Accessory Interface Connector provides power and communication for future accessories Attachment A variety of attachments are available for use with this handpiece Each attachment has a specialized retainer for wires pins tools and or cutti...

Page 6: ...handpiece the handpiece cannot be operated Shifter Knob DRILL Mode For fast speed and low torque rotate shifter knob to DRILL REAM Mode For slow speed and high torque rotate shifter knob to REAM Definitions The symbols located on the equipment and or labeling are defined in this section or in the Symbol Definition Chart See the Symbol Definition Chart supplied with the equipment SYMBOL DEFINITION ...

Page 7: ... with the appropriate battery charger modules See the instructions for use supplied with the battery charger and or battery pack for charging details and specifications Instructions To Install Attachment WARNING To prevent inadvertent running of the handpiece ALWAYS place the F R Safe control in the safe mode position before installing or removing any attachment NOTE Several attachments are availa...

Page 8: ...hooting section DO NOT apply excessive pressure such as bending or prying with a cutting accessory to prevent fracturing the accessory Applying excessive pressure especially during high operating speeds may cause the cutting accessory to bend significantly and result in tissue damage loss of tactile control and the ejection of cutting accessory pieces at a high velocity CAUTIONS DO NOT stall the h...

Page 9: ...e DRILL mode Failure to comply may cause wobble and result in patient and or healthcare staff injury 1 Ensure the handpiece is not running 2 Change the handpiece mode as follows For DRILL mode rotate the shifter knob counterclockwise until it clicks in place Troubleshooting WARNING DO NOT disassemble or service this equipment NOTE For service contact your Stryker sales representative or call Stryk...

Page 10: ...piece with a small brush with stiff non metallic bristles Attachment is damaged Return the attachment for repair Handpiece is damaged Return the handpiece for repair Attachment and or cutting accessory wobbles in handpiece Cutting accessory or wire pin is bent extends too far from the distal end of attachment is the wrong size or is not properly centered in the attachment Reinsert the cutting acce...

Page 11: ...Model System 6 Single Trigger Rotary Handpiece REF 6203 000 000 Dimensions 8 6 inch 219 mm height with large battery pack 1 5 inch 38 mm width 6 0 inch 153 mm length Mass 3 5 lb 1 6 kg with large battery pack Speed 1200 rpm drill 270 rpm ream Mode of Operation Duty Cycle Rest Between Cycles Non continuous Operation 1 minute on 4 minutes off 3 times 3 hours Equipment Type Type BF Applied Part Maxim...

Page 12: ...ial Performance CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety American National Standards Institute Association for the Advancement of Medical Instrumentation ANSI AAMI ES60601 1 2005 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Consolidated Reprint 2009 Amendment 2 2010 Underwriters Laboratorie...

Page 13: ... is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The System 6 Single Trigger Rotary Handpiece REF 6203 000 000 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The System 6 Single Trigger Ro...

Page 14: ... tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines N A N A Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth N A N A Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 ...

Page 15: ...tters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Non ionizing electromagnetic radiation 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 affe...

Page 16: ...according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 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 recom...

Page 17: ...700 Rev E www stryker com ES DE FR IT NL 6203 001 710 JA ZH KO 6203 001 720 SV DA FI PT NO 6203 001 730 PL EL TR 6203 001 750 Stryker Instruments 4100 E Milham Kalamazoo Michigan USA 49001 1 269 323 7700 1 800 253 3210 ...

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