System 7 Dual Trigger Rotary Handpiece Instructions for Use Rev C Feb 2015

System 7 Dual Trigger Rotary Handpiece REF

7205-000-000

Instructions For Use

ENGLISH (EN) 2015-02

7205-001-700 Rev-C

Print Date: Apr 29, 2015 03:46:26 PM 0000043645, Rev. C Effective Date: Apr 29, 2015 11:39:36 AM

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Introduction This 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-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information. If additional information or in-service training is required, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

Indications For Use The Stryker System 7 Battery Powered Heavy Duty System is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement of screws, wires, pins, and other fixation devices.

7205-001-700 Rev-C

NOTE: The Stryker System 7 Dual Trigger Rotary Handpiece (handpiece) is a component of the Stryker System 7 Battery Powered Heavy Duty System.

Contraindications None known.

User/Patient Safety WARNINGS: • Before using any system component, or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the system components prior to use. • Only trained and experienced healthcare professionals should use this equipment. • The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique used for each patient. Stryker, as a manufacturer, does not recommend surgical procedure or technique. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the Heavy Duty Care Instructions manual for processing instructions.

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• Upon initial receipt and before each use, operate the equipment and inspect each component for damage. DO NOT use any equipment if damage is apparent. See the Heavy Duty Care Instructions manual for inspection criteria. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or nitrous oxide. • Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment. Place this equipment into service according to the EMC information contained in this manual. Portable and mobile radio frequency (RF) communications equipment can affect the function of this equipment.

Accessories 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.

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• DO NOT reuse, reprocess, or repackage a device that is intended for single use only. -- A single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. -- Design features may make cleaning difficult. -- Reuse may create a contamination risk and compromise structural integrity resulting in operational failure. -- Critical product information may be lost during repackaging. Failure to comply may lead to infection or cross infection and result in patient and/or healthcare staff injury. NOTES: • A variety of attachments are available for use with this handpiece. Each attachment has a specialized retainer for wires, pins, tools and/or cutting accessories. See the Heavy Duty Rotary Handpiece Attachments Instructions For Use manual for specific attachment and accessory instructions. • For a complete list of accessories, contact your Stryker sales representative. Outside the US, contact your nearest Stryker subsidiary.

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7205-001-700 Rev-C

Accessories (continued)

Features

The following Stryker-approved accessories are sold separately:

Handpiece

DESCRIPTION

REF

Rotary Handpiece Attachments

6203-XXX-XXX series

System 6 Battery Pack, Small

6212-000-000

System 6 Battery Pack, Large

6215-000-000

System 6 Aseptic Battery Kit, Large

6126-000-000

System 6 Aseptic Battery Kit, Small

6127-000-000

Stryker SmartLifeTM Battery Pack, Small

7212-000-000

Stryker SmartLife Battery Pack, Large

7215-000-000

Stryker SmartLife Non-sterile Battery, Large

7126-110-000

Stryker SmartLife Aseptic Housing, Large

7126-120-000

D

Stryker SmartLife Transfer Shield, Large

7126-130-000

Attachment – A variety of attachments are available for use with this handpiece. Each attachment has a specialized retainer for wires, pins, tools and/or cutting accessories.

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

B C

7203-XXX-XXX series

D A

G

F

E

A

Function Switch – Locks one or both of the triggers.

B

Shift Collar – Sets the speed and torque.

C

Attachment Collar – Retains the attachment in the handpiece.

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Handpiece (continued) E

Applied Part – The distal end of the handpiece and the attachment (as defined by the standards listed in the Specifications section under Product Safety Certification).

F

Reverse Trigger – Controls the variable speed operation of the handpiece in a counterclockwise direction.

G

Shift Collar

Forward Trigger – Controls the variable speed operation of the handpiece in a clockwise direction.

Drill Mode – Fast speed, low torque operation

Ream Mode – Slow speed, high torque operation

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 triggers are locked to prevent inadvertent operation of the handpiece.

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7205-001-700 Rev-C

Definitions

Instructions

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.

To Install the Attachment and Accessory

SYMBOL

DEFINITION Forward Trigger or Reverse Trigger – (conditional symbol; action is in the direction of the arrow) Forward Trigger or Reverse Trigger – (conditional symbol; action is in the direction of the arrow) Drill Mode

WARNING: ALWAYS slide the function switch to the safe mode position before installing the attachment or accessory. NOTE: See the Heavy Duty Rotary Handpiece Attachments Instructions For Use manual for specific attachment and accessory instructions. 1. Insert the attachment into the handpiece until the attachment snaps into place.

Ream Mode F/R 1 min / 4 Duty Cycle – See the Specifications min x 3 section. OSC 15s/15s x5 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

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To Install the Attachment and Accessory (continued)

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1. Slide a fully charged battery pack into the handpiece until the battery pack snaps into place.

NOTE: If the attachment has notches, align one of the notches with a tab under the attachment collar before insertion.

2. Gently tug the attachment to make sure the attachment is securely locked in the handpiece. 3. Install a wire, pin, tool, or cutting accessory as required.

To Install the Battery Pack WARNING: ALWAYS slide the function switch to the safe mode position before installing the battery pack. NOTE: See the instructions for use supplied with the battery pack and/or battery charger for charging instructions and specifications.

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/reverse/ oscillate mode position, and then depressing the trigger.

To Operate the Handpiece WARNINGS: • ALWAYS slide the function switch to the safe mode position when the handpiece is idle or when passing the handpiece to another person. • DO NOT change the position of the function switch while the handpiece is operating.

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7205-001-700 Rev-C

To Operate the Handpiece (continued) 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 handpiece is operating. • DO NOT grasp or touch any rotating component while the handpiece is operating. • ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section. • ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. See the Specifications section and/or the instructions for use supplied with the attachment. • DO NOT apply excessive pressure, such as bending or prying, with the accessory. Excessive pressure may bend or fracture the accessory and result in tissue damage, loss of tactile control, and/or the ejection of accessory fragments at a high velocity. • A wobbling attachment and/or accessory may cause bone or tissue damage or inaccurate wire or pin placement. If wobbling occurs, take corrective action as indicated in the Troubleshooting section.

CAUTIONS: • DO NOT stall the handpiece. Failure to comply may damage the electric motor and/or battery pack. If the handpiece jams, release the trigger immediately. Remove any obstructions before continuing to operate the handpiece. • If any power loss is experienced while using the handpiece, ALWAYS replace the battery pack with a fully charged battery pack. Failure to comply may result in a drained or damaged battery pack with a shortened life. 1. Rotate the shift collar to the drill mode or ream mode position. 2. Slide the function switch to the forward or forward/ reverse/oscillate position. 3. Depress the pressure-sensitive trigger for variable speed operation.

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7205-001-700 Rev-C

To Remove the Battery Pack WARNING: ALWAYS slide the function switch to the safe mode position before removing the battery pack. Depress the battery latch and slide the battery pack out of the handpiece.

EN

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 supplied with the equipment.

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Troubleshooting WARNING: DO NOT disassemble or service this equipment. NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. PROBLEM

CAUSE

ACTION

The handpiece does not operate or operates at a reduced speed.

The battery pack is discharged.

Use a Stryker battery charger to recharge the battery pack.

The battery pack is expended.

Replace the battery pack.

The function switch is in the safe mode position.

Slide the function switch to the forward or forward/reverse/oscillate position.

The drivetrain is malfunctioning.

Return the handpiece to Stryker for repair.

The attachment is not fully 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 cutting.

The handpiece operates but the accessory does not move.

The drivetrain is malfunctioning.

Return the handpiece to Stryker for repair.

The handpiece continues to operate after the trigger is released.

The trigger is malfunctioning.

Depress the battery latch and slide the battery pack out of the handpiece. Return the handpiece to Stryker for repair.

The battery pack becomes unusually hot during use.

The circuitry is malfunctioning.

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. Replace the battery pack if required.

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Troubleshooting (continued) PROBLEM

CAUSE

ACTION

The attachment will not fit or cannot be secured in the handpiece.

The attachment and/or the distal end of the handpiece contains debris.

Use a small brush with stiff, non-metallic bristles to clean the attachment and/or the distal end of the handpiece.

The attachment is damaged.

Return the attachment to Stryker for repair.

The handpiece is damaged.

Return the handpiece to Stryker for repair.

The accessory is damaged.

Inspect the accessory for damage and replace the accessory as required.

The accessory is the wrong size for the attachment.

Install 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 position.

Rotate the shift collar to the ream mode position.

The handpiece is noisy and/or vibrates.

The drivetrain is malfunctioning.

Return the handpiece to Stryker for repair.

The handpiece experiences sporadic electrical interference.

Electrical noise is present.

Turn off all electrical equipment not in use in the operating room.

The attachment and/ or accessory wobbles in the handpiece.

Relocate electrical equipment and/or increase spatial distance between electrical equipment. Plug operating room equipment into different operating room outlets.

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7205-001-700 Rev-C

Specifications WARNING: ALWAYS check any documentation that accompanies attachments, burs, pins, and/or blades for special duty cycle and usage instructions. CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. NOTE: Specifications are approximate and may vary between devices or as a result of power supply fluctuations. Model:

System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000)

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 Part:

Less than 51 °C [124 °F] (Maximum surface temperature as tested to the standards listed under Product Safety Certification.)

Power Supply:

Internally Powered Refer to battery housing for voltage rating.

Ingress Protection:

IPX0 Ordinary Equipment

Equipment Type: Type BF Applied Part

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Specifications (continued) 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); CENELEC Amendment A11 (2011)

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7205-001-700 Rev-C

Specifications (continued) Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation:

Humidity Limitation: Atmospheric Pressure Limitation:

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Specifications (continued) Guidance and manufacturer’s declaration - electromagnetic emissions The System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The System 7 Dual Trigger Rotary Handpiece (REF 7205-000000) 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 CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

N/A

The System 7 Dual Trigger Rotary Handpiece (REF 7205-000000) 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.

Voltage fluctuations/flicker emissions IEC 61000-3-3

N/A

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7205-001-700 Rev-C

Specifications (continued) Guidance and manufacturer’s declaration - electromagnetic immunity The System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 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%.

Electrical fast transient/ burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

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 0,5 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 seconds

N/A

3 A/m

3 A/m

Power frequency (50/ 60 Hz) magnetic field IEC 61000-4-8

N/A

N/A

N/A

N/A N/A

N/A

N/A Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.

NOTE: UT is the alternating current mains voltage prior to application of the test level.

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7205-001-700 Rev-C

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Specifications (continued) Guidance and manufacturer’s declaration - electromagnetic immunity The System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

N/A

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

Electromagnetic environment - guidance Portable and mobile RF communications 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 watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, 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: (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 strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) is used exceeds the applicable RF compliance level above, the System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000). b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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7205-001-700 Rev-C

Specifications (continued) Recommended separation distances between portable and mobile RF communications equipment and the System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) The System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System 7 Dual Trigger Rotary Handpiece (REF 7205-000-000) as recommended 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 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 recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800MHz, the separation distance for 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.

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