System 8 Sagittal Saw Instructions for Use Rev AA Sept 2019

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8208-001-700 Rev-AA

Contents

Definitions... 8

Introduction... 3

Instructions... 8

Audience... 3

To Install the Blade... 8

Conventions... 3

To Index the Blade Mount... 9

Contact Information... 3

To Install the Battery Pack... 10

Indications For Use... 3

To Operate the Handpiece... 10

Contraindications... 3

To Remove the Battery Pack... 11

Safety Directives... 4

Care Instructions... 11

Accessories... 5

Troubleshooting... 12

Blades... 6

Specifications... 15

Battery Packs... 6

Product Safety Certification... 16

Insert Trays... 6

Product Safety Compliance... 17

Features... 7

Electromagnetic Compatibility... 18

Handpiece... 7 Function Switch... 7

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8208-001-700 Rev-AA

Introduction This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product. Keep and consult this reference manual during the life of the product. NOTE: The user and/or patient should report any serious product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.

Audience This manual is intended for in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians.

Conventions 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.

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▪▪ A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. ▪▪ A NOTE supplements and/or clarifies procedural information.

Contact Information For additional information, including safety information, in-service training, or current literature, contact your Stryker sales representative or call Stryker customer service at 1-269-323-7700 or 1-800-253-3210. Outside the US, contact your nearest Stryker subsidiary.

Indications For Use The Stryker System 8 Sagittal Battery Powered Heavy Duty System is intended for use in the cutting and shaping of bone and other bone related tissue in a variety of surgical procedures.

Contraindications None known.

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Safety Directives WARNINGS: ▪▪ Before using this equipment, or any component compatible with this equipment, read and understand the instructions for use. Pay particular attention to safety information. Become familiar with the equipment before use. ▪▪ Only healthcare professionals trained and experienced in the use of this medical device should operate 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, operate the equipment and inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. See the care instructions manual supplied with the handpiece. ▪▪ Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the care instructions manual supplied with the handpiece. ▪▪ 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. ▪▪ ALWAYS lock the handpiece trigger before installing or removing attachments or accessories.

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Accessories WARNINGS: ▪▪ Use only Stryker-approved electronic components and accessories. Failure to comply may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. ▪▪ DO NOT modify any equipment without the authorization of the manufacturer. ▪▪ Using non-Stryker blades may result in fragmentation or ejection of the blade during use. ▪▪ Upon initial receipt and before use, visually inspect the package for damage to confirm the integrity of the sterile barrier. Do not use the product if damage is apparent, the sterile barrier is compromised, or the package is unintentionally opened.

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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: ▪▪ Sterile cutting accessories are sterilized by irradiation. ▪▪ For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

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The following Stryker-approved accessories are sold separately:

DESCRIPTION

REF

System 8 Battery Packs

8212-000-000 8215-000-000

REF 2108-XXX-XXX series 41XX-XXX-XXX series 42XX-XXX-XXX series 530X-X10-XXX series 5108-127-070

SmartLife® Battery Packs

7212-000-000 7215-000-000

SmartLife Non-sterile Batteries

7126-110-000 7222-110-000

SmartLife Aseptic Housings

7126-120-000 7222-120-000

SmartLife Transfer Shields

7126-130-000 7222-130-000

System 6 Battery Packs

61XX-XXX-XXX series 62XX-XXX-XXX series

6212-000-000 6215-000-000

System 6 Aseptic Battery Kits

6126-000-000 6127-000-000

Blades DESCRIPTION 2108 Series Sagittal Blade Dual Cut Sagittal Blade

Heavy Duty Sagittal Blade Stryker-OSC Blade Stryker Performance Series® Sagittal Blade

Battery Packs

Insert Trays

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DESCRIPTION

REF

Insert Trays

4405-452-010 7102-450-010 7102-452-010 7102-454-010 7102-458-010

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Features

B

NOTE: The Stryker System 8 Sagittal Saw (handpiece) is a component of the Stryker System 8 Battery Powered Heavy Duty System.

Blade Mount – Retains the blade in the handpiece.

C

Center Pin – Engages with the blade to secure the blade in the blade mount.

D

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

E

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

F

Trigger – Controls the variable speed operation of the handpiece.

Handpiece The System 8 Sagittal Saw is battery powered and has a trigger and a function switch.

B

C

Fast Mode – The handpiece will operate at high speed when the trigger is depressed.

A

D E F A

Function Switch

Function Switch – Sets the speed or locks the trigger. See the Function Switch section.

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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.

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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 General warning sign Fast Mode

Instructions To Install the Blade WARNING: Make sure the FULL INSERT mark is completely inside of the blade mount and the center pin is securely engaged with the blade after installation. 1. Lock the handpiece trigger. 2. Rotate the blade mount lever to the unlock position.

Standard Mode Blade mount locked Blade mount unlocked 1 min / 4 min x5

Duty Cycle – See the Specifications section. Full insert

SAG SAW

8

Sagittal Saw

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8208-001-700 Rev-AA

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

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To Index 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. 1. Lock the handpiece trigger. 2. Depress the index button and rotate the blade mount to the desired cutting angle.

4. Maintain the vertical handpiece orientation and rotate the blade mount lever to the lock position to lock the blade in the blade mount.

3. Release the index button. 4. Gently turn the blade mount to ensure the blade mount is securely locked in position.

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

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To Install the Battery Pack NOTE: See the instructions for use supplied with the battery pack and/or battery charger for charging instructions and specifications. 1. Lock the handpiece trigger. 2. Slide a fully charged battery pack into the handpiece until the battery pack snaps into place.

8208-001-700 Rev-AA

To Operate the Handpiece WARNINGS: ▪▪ ALWAYS lock the handpiece trigger when the handpiece is idle or when passing the handpiece to another person. ▪▪ Before operating the handpiece, ALWAYS gently tug the cutting accessory to make sure the cutting accessory is securely locked in the handpiece. ▪▪ DO NOT change the position of the function switch 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.

3. Gently tug the battery pack to make sure the battery pack is securely locked in the handpiece. 4. Test the operation of the handpiece by unlocking and then depressing the trigger.

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▪▪ 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.

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CAUTIONS:

To Remove the Battery Pack

▪▪ When operating the handpiece, let the accessory do the cutting. DO NOT apply excessive pressure with the accessory. Excessive pressure may bend the blade and reduce the cutting quality.

1. Lock the handpiece trigger. 2. Depress the battery latch and slide the battery pack out of the handpiece.

▪▪ 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. NOTE: See the Features section for mode descriptions. 1. Slide the function switch to the fast or standard position. 2. Depress the pressure-sensitive trigger to operate the handpiece.

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To Remove the Blade 1. Lock the handpiece trigger. 2. Rotate the blade mount lever to the unlock position, and then remove the blade 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 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

The handpiece does not operate The battery pack is discharged. or operates at a reduced speed.

ACTION Use a Stryker battery charger to recharge the battery pack.

The battery pack is expended.

Replace the battery pack.

The handpiece trigger is locked.

Unlock the handpiece trigger. See the Features section.

The function switch is in the standard position.

Set the function switch to the fast position.

The handpiece is damaged.

Return the equipment to Stryker for repair.

The handpiece operates but the cutting accessory does not move.

The handpiece is damaged.

Return the equipment to Stryker for repair.

The handpiece continues to operate after the trigger is released.

The handpiece is damaged.

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

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PROBLEM

CAUSE

ACTION

The equipment becomes unusually hot during use.

The duty cycle has been exceeded.

ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. See the Specifications section.

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. Replace the battery pack if required.

The distal end of the handpiece contains debris.

See the care instructions manual supplied with the handpiece.

The cutting accessory is not a Stryker product.

Use a Stryker cutting accessory.

The cutting accessory is damaged.

Replace the cutting accessory.

The handpiece is damaged.

Return the equipment to Stryker for repair.

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

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PROBLEM

CAUSE

ACTION

The handpiece is noisy and/or vibrates.

The cutting accessory is not properly installed in the handpiece.

Remove and properly install the cutting accessory. Make sure the cutting accessory is securely locked in the handpiece.

The cutting accessory is not a Stryker product.

Use a Stryker cutting accessory.

The cutting accessory is damaged.

Replace the cutting accessory.

The handpiece is damaged.

Return the equipment to Stryker for repair.

Electrical noise is present.

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

The handpiece experiences sporadic electrical interference.

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

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Specifications WARNING: ALWAYS consult any documentation that accompanies attachments and/or accessories for product-specific duty cycles and instructions for use. CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. Model:

System 8 Sagittal Saw (REF 8208-000-000)

Dimensions:

156 mm [6.1 inch] height, 38 mm [1.5 inch] width, 171 mm [6.7 inch] length

Mass:

1.09 kg [2.4 lb]

Speed:

12000 cpm (fast mode), 10000 cpm (standard mode)

Excursion:

5 degree arc

Mode of Operation:

Non-continuous

Duty Cycle:

1 minute on/4 minutes off, 5 times

Rest Between Cycles:

3 hours

Applied Part(s):

The distal end of the handpiece as defined by the manufacturer

Maximum Temperature Less than 51 °C [124 °F] as tested to the Product Safety Certification of Applied Part(s): standards Power Supply:

Internally powered. Refer to battery housing for voltage rating.

Ingress Protection:

IPX9 during cleaning and sterilization

Equipment Type:

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Type BF Applied Part

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Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation: 75 %

Humidity Limitation: 10 %

Atmospheric Pressure Limitation:

Product Safety Certification Canadian Standards Association (CSA) International Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:14, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD) 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)

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Product Safety Compliance International Electrotechnical Commission (IEC) IEC 60601-1:2005, Ed: 3.1, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; Corrigendum 1 (2006); Corrigendum 2 (2007); Amendment 1 (2012) IEC 60601-1-2:2014 Ed: 4, Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Electromagnetic Disturbances IEC 60601-1-2:2007 Ed: 3, Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Electromagnetic Compatibility IEC 60601-1-6:2010+ A1:2013 Ed. 3.1, Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance – Usability IEC 62366-1:2007+ A1:2014 Ed 1.1, Medical Devices - Part 1: Application of Usability Engineering to Medical Devices European Committee for Electrotechnical Standardization (CENELEC) 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)

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Electromagnetic Compatibility Guidance and manufacturer’s declaration - electromagnetic emissions The System 8 Sagittal Saw (REF 8208-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 8 Sagittal Saw (REF 8208-000-000) should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

The System 8 Sagittal Saw (REF 8208-000-000) 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.

Class B

The System 8 Sagittal Saw (REF 8208-000-000) 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.

CISPR 11 RF emissions CISPR 11 Harmonic emissions

N/A

IEC 61000-3-2 Voltage fluctuations/flicker emissions

N/A

IEC 61000-3-3

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Guidance and manufacturer’s declaration - electromagnetic immunity The System 8 Sagittal Saw (REF 8208-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the System 8 Sagittal Saw (REF 8208-000-000) should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge (ESD)

±2, ±4, ±6, ±8 kV Contact

±2, ±4, ±6, ±8 kV Contact

±2, ±4, ±8, ±15 kV Air

IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4

±2, ±4, ±8, ±15 kV Air ±2 kV at 100 kHz repetition frequency for power supply lines ±1 kV at 100 kHz repetition frequency for input/output lines

±2 kV at 100 kHz repetition frequency for power supply lines

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

N/A

±1 kV at 100 kHz repetition frequency for input/output lines

Surge

±0.5, ±1 kV line(s) to line(s)

N/A

IEC 61000-4-5

±0.5, ±1, ±2 kV line(s) to earth

N/A

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Electromagnetic environment guidance

N/A

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Immunity test

IEC 60601 test level

Compliance level

Voltage dips, short interruptions and voltage variations on power supply input lines

<5% UT (>95% dip in UT) for 0.5 cycle

N/A

0% UT (100% dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

N/A

0% UT (100% dip in UT) for 1 cycle at 0°

N/A

40% UT (60% dip in UT) for 5 cycles

N/A

70% UT (30% dip in UT) for 25 & 30 cycles at 0°

N/A

<5% UT (>95% dip in UT) for 5 s

N/A

0% UT (100% dip in UT) for 5 s

N/A

3 A/m, 30 A/m

3 A/m, 30 A/m

IEC 61000-4-11

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

Electromagnetic environment guidance

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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