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Summary of Contents for Stryker System 8
- Page 1 System 8 Dual Trigger Rotary Handpiece 8205-000-000 Instructions For Use ENGLISH (EN) 2019-09 8205-001-700 Rev-AA www.stryker.com...
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Page 2: Table Of Contents
Handpiece ....7 Function Switch ....8 Shift Collar ....8 www.stryker.com... -
Page 3: Introduction
This manual is intended for in-service trainers, Indications For Use physicians, nurses, surgical technologists, and biomedical equipment technicians. The Stryker System 8 Dual Trigger Rotary Battery Powered Heavy Duty System is intended for Conventions use in the drilling, reaming, and decorticating of... -
Page 4: Safety Directives
Place and the specific technique used for each this equipment into service according to the patient. Stryker, as a manufacturer, does not EMC information contained in this manual. recommend surgical procedure or technique. Portable and mobile radio frequency (RF) communications equipment can affect the function of this equipment. -
Page 5: Accessories
• For a complete list of accessories, contact barrier is compromised, or the package is your Stryker sales representative or call unintentionally opened. Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. -
Page 6: Battery Packs
• DO NOT reuse, reprocess, or repackage a device that is intended for single use only. DESCRIPTION - A single use device may not withstand chemical, chemical vapor, or high System 8 Battery Packs 8212-000-000 temperature sterilization reprocessing. 8215-000-000 - Design features may make cleaning... -
Page 7: Features
8205-001-700 Rev-AA Features Function Switch – Locks one or both of the triggers. See the Function Switch NOTE: The Stryker System 8 Dual Trigger Rotary section. Handpiece (handpiece) is a component of the Shift Collar – Sets the speed and Stryker System 8 Battery Powered Heavy Duty torque. -
Page 8: Function Switch
F/R 1 min / inadvertent operation of the Duty Cycle – See the 4 min x 3 handpiece. OSC 15s/15s Specifications section. Shift Collar Drill Mode – Fast speed, low torque operation Ream Mode – Slow speed, high torque operation www.stryker.com... -
Page 9: Instructions
3. Gently tug the attachment to make sure the attachment is securely locked in the handpiece. 4. Install a wire, pin, tool, or cutting accessory as required. See the instructions for use supplied with the attachment. www.stryker.com... -
Page 10: To Install The Battery Pack
3. Gently tug the battery pack to make sure mode position when a reamer attachment the battery pack is securely locked in the and/or accessory is installed in the handpiece. handpiece. 4. Test the operation of the handpiece by unlocking and then depressing the trigger. www.stryker.com... - Page 11 2. Slide the function switch to the forward or wire or pin placement. If wobbling occurs, forward/reverse/oscillate position. take corrective action as indicated in the Troubleshooting section. 3. Depress one of the pressure-sensitive triggers to operate the handpiece. www.stryker.com...
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Page 12: To Remove The Battery Pack
2. Remove the accessory from the attachment. 3. 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 supplied with the equipment. www.stryker.com... -
Page 13: Troubleshooting
8205-001-700 Rev-AA Troubleshooting WARNING: DO NOT disassemble or service this equipment without the authorization of the manufacturer. NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. PROBLEM CAUSE... - Page 14 The handpiece is damaged. Return the equipment to Stryker for repair. The battery pack is damaged. Use a Stryker battery charger to check the integrity of the battery pack. See the instructions for use supplied with the battery charger for more information.
- Page 15 The attachment is damaged. Return the equipment to Stryker for repair. The handpiece is damaged. Return the equipment to Stryker for repair. The pin accessory cannot The collet mechanism is...
- Page 16 If wobble persists, attachment, or is not properly return the handpiece and centered in the attachment. attachment to Stryker for repair. A reamer attachment and/or Rotate the shift collar to the accessory is installed in the ream mode position.
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Page 17: Specifications
CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) Model: Dimensions: 150 mm [5.9 inch] height, 39 mm [1.5 inch] width, 154 mm [6.1 inch] length Mass: 1.04 kg [2.3 lb]... -
Page 18: Product Safety Certification
American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012, Medical Electrical Equipment — Part 1: General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009/(R) 2012); Amendment 2 (2010/(R) 2012); Amendment 1 (2012) www.stryker.com... -
Page 19: Product Safety Compliance
EN 60601-1:2006+A12:2014, Ed: 3.1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); CENELEC Corrigendum (2010); CENELEC Amendment A11 (2011); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014) www.stryker.com... -
Page 20: Electromagnetic Compatibility
The System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) should assure that it is used in such an environment. - Page 21 The System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) should assure that it is used in such an environment.
- Page 22 Power frequency magnetic 60 Hz) magnetic field fields should be at levels characteristics of a typical location IEC 61000-4-8 in a typical commercial or hospital environment. NOTE: U is the alternating current mains voltage prior to application of the test level. www.stryker.com...
- Page 23 The System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) should assure that it is used in such an environment.
- Page 24 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) is used exceeds the applicable RF compliance level above, the System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000).
- Page 25 The System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System 8 Dual Trigger Rotary Handpiece (REF 8205-000-000) can help prevent electromagnetic interference by maintaining a...
- Page 28 ES/DE/FR/IT/NL 8205-001-710 JA/ZH/KO 8205-001-720 SV/DA/FI/PT/NO 8205-001-730 PL/EL 8205-001-750 8205-001-760 8205-001-770 Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210 2019-09 8205-001-700 Rev-AA www.stryker.com...
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