System 7 Sagittal Saw Instructions for Use Rev B May 2012

Instructions for Use

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System 7 Sagittal Saw REF

7208-000-000

Instructions For Use

ENGLISH (EN) 2012-05

7208-001-700 Rev-B

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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.

7208-001-700 Rev-B

NOTE: The Stryker System 7 Sagittal Saw (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.

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7208-001-700 Rev-B

User/Patient Safety (continued) WARNINGS: • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the Heavy Duty Care Instructions manual for processing instructions. • 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 non-Stryker cutting accessories may result in fragmentation or ejection of the cutting accessory during use. • Using other electronic components and accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. • DO NOT reuse, reprocess, or re-package 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 compromise the structural integrity of the cutting accessory and result in fragmentation during use. Critical product information may be lost if the cutting accessory is re-packaged. NOTE: For a complete list of accessories, contact your Stryker sales representative. Outside the US, contact your nearest Stryker subsidiary.

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7208-001-700 Rev-B

Accessories (continued)

Features

The following Stryker-approved accessories are sold separately:

Handpiece

DESCRIPTION

REF

Blades

2108-XXX-XXX series

B C

41XX-XXX-XXX series 42XX-XXX-XXX series

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

D E F

Function Switch – Sets the speed or locks the trigger.

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

Blade Mount – Retains the blade in the handpiece.

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7208-001-700 Rev-B

Handpiece (continued) D

Blade Mount Lever – Unlocks the blade mount to allow installation of the blade.

Index Button – Allows the blade mount to be indexed in 45‑degree increments to achieve the desired cutting angle.

Trigger – Controls the variable speed operation of the handpiece.

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 Fast Mode Standard Mode

Function Switch

Blade Mount Locked

Fast Mode – The handpiece will operate at high speed when the trigger is depressed. Standard Mode – The handpiece will operate at standard speed when the trigger is depressed. Safe Mode – The trigger is locked to prevent inadvertent operation of the handpiece.

Blade Mount Unlocked 1 min / 4 min x 5

Duty Cycle – See the Specifications section. Full Insert General warning sign Consult instructions for use Per Directive 2002/96/EC, product must be collected separately. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information.

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7208-001-700 Rev-B

Instructions

2. Hold the handpiece in a vertical orientation and fully insert the blade into the blade mount.

To Install the Blade WARNINGS: • ALWAYS slide the function switch to the safe mode position before installing the blade. • Make sure the FULL INSERT mark is completely inside of the blade mount after installation. 1. Rotate the blade mount lever to the unlock position. 3. Maintain the vertical handpiece orientation and rotate the blade mount lever to the lock position to lock the blade in the blade mount.

4. Gently tug the blade to make sure the blade is securely locked in the blade mount.

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7208-001-700 Rev-B

To Index the Blade Mount

To Install the Battery Pack

WARNING: ALWAYS slide the function switch to the safe mode position before indexing the blade mount. CAUTION: ALWAYS securely lock the blade mount in position before operating the handpiece. NOTE: The blade mount can be locked in eight possible cutting angle positions.

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.

1. Depress the index button and rotate the blade mount to the desired cutting angle.

2. Release the index button. 3. Gently turn the blade mount to ensure the blade mount is securely locked in position.

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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 fast or standard mode position, and then depressing the trigger.

7208-001-700 Rev-B

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. • Before operating the handpiece, ALWAYS gently tug the blade to make sure the blade is securely locked in the blade mount. • 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. • DO NOT apply excessive pressure, such as bending or prying, with the blade. Excessive pressure may bend or fracture the blade and result in tissue damage, loss of tactile control, and/or the ejection of blade fragments at a high velocity.

CAUTIONS: • When operating the handpiece, let the blade do the cutting. DO NOT apply excessive pressure with the blade. Excessive pressure may bend the blade and reduce the cutting quality. • 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. Slide the function switch to the fast or standard position. 2. Depress the pressure-sensitive trigger for variable speed operation.

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7208-001-700 Rev-B

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.

Cleaning and Disinfection See the Heavy Duty Care Instructions manual supplied with the equipment.

Inspection and Testing See the Heavy Duty Care Instructions manual supplied with the equipment.

Sterilization See the Heavy Duty Care Instructions manual supplied with the equipment.

To Remove the Blade WARNING: ALWAYS slide the function switch to the safe mode position before removing the blade. Rotate the blade mount lever to the unlock position, and then remove the blade from the handpiece.

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Storage and Handling See the Heavy Duty Care Instructions manual supplied with the equipment.

Disposal/Recycle See the Heavy Duty Care Instructions manual supplied with the equipment.

7208-001-700 Rev-B

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 function switch is in the standard position.

Set the function switch to the fast position.

The battery pack is expended.

Replace the battery pack.

The function switch is in the safe mode position.

Set the function switch to the fast or standard position.

The drivetrain is malfunctioning.

Return the handpiece to Stryker for repair.

The handpiece operates but the blade 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. Replace the battery pack as required.

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7208-001-700 Rev-B

Troubleshooting (continued) PROBLEM

CAUSE

ACTION

The blade will not fit or cannot be secured in the blade mount.

The blade mount contains debris.

Use a small brush to clean the blade mount.

The blade is not a Stryker product.

Use a Stryker blade.

The blade mount is damaged.

Return the handpiece to Stryker for repair.

The blade is not a Stryker product.

Use a Stryker blade.

The drivetrain is malfunctioning.

Return the handpiece to Stryker for repair.

The handpiece is noisy and/ or vibrates.

The handpiece experiences Electrical noise is present. sporadic electrical interference.

Turn off all electrical equipment not in use in the operating room. Relocate electrical equipment and/ or increase spatial distance between electrical equipment. Plug operating room equipment into different operating room outlets.

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7208-001-700 Rev-B

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 Sagittal Saw (REF 7208-000-000)

Dimensions:

165 mm [6.5 inch] height 38 mm [1.5 inch] width 173 mm [6.8 inch] length

Mass:

1.05 kg [2.3 lb]

Speed:

12,000 cpm (fast) 10,000 cpm (standard)

Excursion:

5 degree arc

Mode of Operation:

Non-continuous Operation

Duty Cycle:

1 minute on/4 minutes off, 5 times

Rest Between Cycles:

3 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

Ingress Protection:

9.9 V

(Direct current) Stryker SmartLife Battery Pack (Lithium-Ion)

9.6 V

System 6 Battery Pack (Nickel-Cadmium)

IPX0 Ordinary Equipment

Equipment Type: Type BF Applied Part

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7208-001-700 Rev-B

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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7208-001-700 Rev-B

Specifications (continued) Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation:

Humidity Limitation: Atmospheric Pressure Limitation:

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7208-001-700 Rev-B

Specifications (continued) Guidance and manufacturer’s declaration - electromagnetic emissions The System 7 Sagittal Saw (REF 7208-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 7 Sagittal Saw (REF 7208-000-000) 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 Sagittal Saw (REF 7208-000-000) 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 CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

N/A

The System 7 Sagittal Saw (REF 7208-000-000) 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.

Voltage fluctuations/flicker emissions IEC 61000-3-3

N/A

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7208-001-700 Rev-B

Specifications (continued) Guidance and manufacturer’s declaration - electromagnetic immunity The System 7 Sagittal Saw (REF 7208-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 7 Sagittal Saw (REF 7208-000-000) 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

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

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

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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7208-001-700 Rev-B

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 Sagittal Saw (REF 7208-000-000), 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 Sagittal Saw (REF 7208-000-000) is used exceeds the applicable RF compliance level above, the System 7 Sagittal Saw (REF 7208-000-000) 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 Sagittal Saw (REF 7208-000-000). b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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7208-001-700 Rev-B

Specifications (continued) Recommended separation distances between portable and mobile RF communications equipment and the System 7 Sagittal Saw (REF 7208-000-000) The System 7 Sagittal Saw (REF 7208-000-000) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System 7 Sagittal Saw (REF 7208000-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System 7 Sagittal Saw (REF 7208-000-000) 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

N/A

1.2

2.3

N/A

3.8

7.3

100

N/A

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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ES/DE/FR/IT/NL JA/ZH/KO SV/DA/FI/PT/NO PL/EL

7208-001-710 7208-001-720 7208-001-730 7208-001-750

Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210

Stryker France ZAC Satolas Green Pusignan Av. de Satolas Green 69881 MEYZIEU Cedex France 2012-05

7208-001-700 Rev-B

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System 7 Sagittal Saw Instructions for Use Rev B May 2012