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6209-001-708 Rev-E

Features

Handpiece

•

Battery Latch

- Depress the latch to release the battery pack from the handpiece.

•

Battery Pack

- Contains a rechargeable battery that provides power to the handpiece.

•

Head

- The head may be indexed in 45-degree increments and can turn in a complete 360-degree rotation to

achieve the desired cutting angle.

•

Cartridge

- Single use, disposable cutting accessory with a stationary bar component and oscillating cutting tip.

•

Index Button

- Press to rotate and orient the position of the head as desired.

•

Wingnut

- Used to secure the cartridge to the handpiece.

•

Trigger Switch

- The trigger is pressure sensitive for variable speed operation.

•

FAST/STD/Safe Control

- Based on its position, allows the handpiece to operate in the FAST or STD mode; the

safe mode position prevents inadvertent operation of the handpiece.

•

Accessory Interface

- Connector provides power and communication for future accessories.

•

Applied Parts

- The distal end of the handpiece and the cartridge (as defined by the standards listed in the

Specifications

section under

Product Safety Certification)

Wingnut

Cartridge

Trigger Switch

Battery Latch

Battery Pack

FAST/STD/Safe Control

Head

Index Button

Accessory Interface

Applied Parts

Содержание Precision 6209-000-000

Страница 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 6209 001 708 E ...

Страница 2: ...2015 06 6209 001 708 Rev E www stryker com Instructions For Use ENGLISH EN System 6 Stryker Precision Oscillating Tip Saw REF 6209 000 000 ...

Страница 3: ...of bone and other bone related tissue The intended surgical applications are orthopedic surgeries involving the shoulder hip knee and ankle 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 instructions Pay pa...

Страница 4: ...ctromagnetic immunity of the system DO NOT modify any system component or accessory ALWAYS use a Stryker Precision Oscillating Tip Saw Cartridge with this handpiece 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 and lead to infection or cross infection Reprocessing may co...

Страница 5: ...ition of the head as desired Wingnut Used to secure the cartridge to the handpiece Trigger Switch The trigger is pressure sensitive for variable speed operation FAST STD Safe Control Based on its position allows the handpiece to operate in the FAST or STD mode the safe mode position prevents inadvertent operation of the handpiece Accessory Interface Connector provides power and communication for f...

Страница 6: ... Slide the FAST STD Safe control to the STD standard mode position to allow the handpiece to operate at high torque and standard speed when the trigger switch is depressed Safe Mode Slide the FAST STD Safe control to the safe mode position to lock the trigger and prevent inadvertent operation of the handpiece the handpiece cannot be operated Cartridge NOTE The incremental marks on the length of th...

Страница 7: ...ion Instructions WARNING ALWAYS place the FAST STD Safe control in the safe mode position while the handpiece is idle before installing or removing any accessory or battery pack or when passing the handpiece to another person To Install the Cartridge WARNING ALWAYS install the cartridge with the FULL INSERT marking visibly facing up Failure to comply may result in product damage and patient and or...

Страница 8: ... onto the surface of the head The post will pass through the large opening in the cartridge keyhole 5 Guide the cartridge as it springs back toward the handpiece Make sure the post is aligned with the FULL INSERT mark see figure 2 The cartridge should be fully seated under the tabs on the head Figure 2 Align Post with FULL INSERT mark 6 Rotate and align the wingnut dot with the LOCK symbol to secu...

Страница 9: ...iece is designed to accept the Stryker Large Battery Pack REF 6215 000 000 only This battery pack can be charged in the Stryker System 6 Battery Charger REF 6110 120 000 or the Universal Battery Charger REF 7110 120 000 configured with the appropriate battery charger module See the instructions for use supplied with the battery charger and or battery pack for charging details and specifications 1 ...

Страница 10: ... or removing any accessory or when passing the handpiece to another person DO NOT place a hand on the drive pins located on the blade mount of the handpiece Friction between the drive pins and hand may create heat DO NOT apply excessive pressure such as bending or prying with a cutting accessory to prevent fracturing and or excessively heating the accessory CAUTIONS DO NOT stall the handpiece Fail...

Страница 11: ...to the safe mode position 2 To unlock the cartridge rotate the wingnut to the UNLOCK position Pull the cartridge away from the head and lift the cartridge away from the handpiece see figure 1 3 Properly dispose of the single use cartridge Battery Pack Removal Depress the battery latch and pull the battery pack out of the handpiece Care Instructions For processing instructions and disposal recycle ...

Страница 12: ...g Return the handpiece for repair Motor runs but cartridge does not move Drivetrain is malfunctioning Return the handpiece for repair Cartridge is malfunctioning Replace the cartridge Battery pack becomes unusually hot during use Circuitry is malfunctioning Check the battery pack on the Stryker charger and replace the battery pack if required See the instructions for use supplied with the battery ...

Страница 13: ...th large battery pack 1 6 inch 41 mm width 7 2 inch 183 mm length Mass 3 6 lb 1 63 kg with large battery pack Speed 10 000 cycles per minute STD mode 12 000 cycles per minute FAST mode Excursion 12 degree arc Mode of Operation Duty Cycle Rest Between Cycles Non Continuous Operation 1 minute on 4 minutes off 5 times 3 hours Equipment Type Type BF Applied Part Maximum Temperature of Applied Parts Le...

Страница 14: ...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...

Страница 15: ...onment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The System 6 Stryker Precision Oscillating Tip Saw REF 6209 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 Stryker Precision Oscillating Tip Sa...

Страница 16: ...eramic 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 ...

Страница 17: ...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...

Страница 18: ...ended below 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 abo...

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Страница 21: ...708 Rev E 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 6209 001 710 JA ZH KO 6209 001 720 SV DA FI PT NO 6209 001 730 PL EL TR 6209 001 750 ...

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