System 8 Cordless Driver Handpiece Instructions for Use Rev AA Sept 2019

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4505-001-700 Rev-AA

Contents

Definitions... 9

Introduction... 3

Instructions... 9

Audience... 3

To Install the Attachment and Accessory . . 9

Conventions... 3

To Install the Battery Pack... 10

Contact Information... 3

To Operate the Handpiece... 11

Indications For Use... 3

To Remove the Battery Pack... 12

Contraindications... 4

To Remove the Attachment and Accessory . 13

Safety Directives... 4

Care Instructions... 13

Accessories... 5

Troubleshooting... 14

Attachments... 5

Specifications... 18

Cutting Accessories... 5

Product Safety Certification... 19

Battery Packs... 7

Product Safety Compliance... 20

Insert Trays... 7

Electromagnetic Compatibility... 21

Features... 7 Handpiece... 7 Function Switch... 8

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4505-001-700 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 Cordless Driver system is a surgical battery-powered instrument intended for use during general surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone. Accessories or attachments may include a pin/ wire driver, a driver bit, and/or a saw blade. This system is designed for general surgical use where hard tissue and/or bone must be cut, reamed, drilled, and/or fixated with screws, including but not limited to the hand, wrist, elbow, sternum, shoulder, foot, ankle, knee, and hip. 3

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4505-001-700 Rev-AA

Contraindications None known.

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.

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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 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 triggers before installing or removing attachments or accessories.

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4505-001-700 Rev-AA

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. 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 instructions for use supplied with the attachment. ▪▪ 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:

Attachments DESCRIPTION

REF (SERIES)

Cordless Driver Attachments

4505-XXX-XXX 4100-XXX-XXX

PoweReam® Attachments

4405-XXX-XXX

Cutting Accessories WARNINGS: ▪▪ 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. ▪▪ Use adequate irrigation during cutting to prevent heat generation.

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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.

4505-001-700 Rev-AA

DESCRIPTION

REF (SERIES)

Sagittal Saw Attachment Blades

2296-003-XXX 2296-023-XXX 2296-033-XXX 5400-003-XXX 5400-134-XXX

Radiolucent Attachment Drill Bits

4200-355-0XX

Bur Attachment Cutting Accessories

0277-010-XXX 1607-002-XXX 1608-002-XXX 1608-006-XXX 1900-01X-0XX 5120-100-0XX

NOTE: Sterile cutting accessories are sterilized by irradiation.

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Features

Battery Packs DESCRIPTION

REF

System 8 Battery Packs

8212-000-000 8215-000-000

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

6212-000-000 6215-000-000

System 6 Aseptic Battery Kits

6126-000-000 6127-000-000

NOTE: The Stryker System 8 Cordless Driver Handpiece (handpiece) is a component of the Stryker System 8 Battery Powered Heavy Duty System.

Handpiece The System 8 Cordless Driver Handpiece is battery powered and has two triggers and a function switch.

Insert Trays DESCRIPTION

REF

Insert Trays

4405-451-010 4405-452-010 4405-453-010

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D A C B

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A

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

B

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

C

Function Switch – Locks one or both of the triggers. See the Function Switch section.

D

Release Button – Press the release button to remove the attachment from the handpiece.

NOTE: Depress both triggers simultaneously to operate the handpiece in oscillate mode.

Function Switch POSITION

DESCRIPTION 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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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 General warning sign

F/R 1 min / 4 min X 5 OSC 15 s / 15 s X 5

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Duty Cycle – See the Specifications section.

WARNING: ALWAYS use Stryker-approved attachments with two J-slots. Older attachments with only one J-slot cannot be securely installed in the handpiece. CORRECT

INCORRECT

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1. Lock the handpiece triggers.

To Install the Battery Pack

2. Insert the attachment into the handpiece until the attachment snaps into place.

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

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.

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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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4505-001-700 Rev-AA

To Operate the Handpiece WARNINGS: ▪▪ ALWAYS lock the handpiece triggers when the handpiece is idle or when passing the handpiece to another person. ▪▪ 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 grasp or touch any rotating component while the handpiece is operating. ▪▪ 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 and/or the instructions for use supplied with the attachment.

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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. ▪▪ 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. ▪▪ DO NOT use the handpiece to completely drive a screw into bone. The handpiece is only validated to partially advance a screw into bone through a guide hole. Use a torque limiter to manually tighten the screw against the bone and achieve the appropriate torque for finished screw placement. ▪▪ DO NOT use the handpiece to drive a screw smaller than 2.3 mm in diameter. The handpiece is only validated to drive screws with diameters of 2.3 mm or larger.

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4505-001-700 Rev-AA

CAUTIONS:

To Remove the Battery Pack

▪▪ 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.

1. Lock the handpiece triggers. 2. Depress the battery latch and slide the battery pack out of 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 forward or forward/reverse/oscillate mode position. 2. Depress one of the pressure-sensitive triggers to operate the handpiece. NOTE: Depress both triggers simultaneously to operate the handpiece in oscillate mode.

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4505-001-700 Rev-AA

To Remove the Attachment and Accessory 1. Lock the handpiece triggers. 2. Remove the wire, pin, tool, or cutting accessory as required. See the instructions for use supplied with the attachment.

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Care Instructions For processing instructions and disposal/recycle information, see the care instructions manual supplied with the equipment.

3. Press the release button and remove the attachment from the handpiece.

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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.

The handpiece operates but the cutting accessory does not move.

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 handpiece is damaged.

Return the equipment 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.

Excessive pressure is being Release the pressure and allow applied to the cutting accessory. the cutting accessory to do the cutting. The handpiece is damaged.

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Return the equipment to Stryker for repair.

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PROBLEM

CAUSE

ACTION

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.

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 and/or the instructions for use supplied with the attachment.

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 release button is jamming.

Press and hold the release button while inserting attachment. Make sure the attachment is securely locked in the handpiece.

The attachment is difficult to install or remove from the handpiece.

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PROBLEM

CAUSE

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

The attachment and/or the distal See the care instructions end of the handpiece contains manual supplied with the debris. handpiece.

The attachment and/or accessory wobbles in the handpiece.

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ACTION

The attachment is damaged.

Return the equipment to Stryker for repair.

The handpiece is damaged.

Return the equipment 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.

The attachment and/or handpiece is damaged.

Return the equipment to Stryker for repair.

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PROBLEM

CAUSE

ACTION

The pin accessory cannot be removed from the collet attachment.

The collet mechanism is jammed.

Gently tap the side of the pin to dislodge it from the collet. CAUTION: DO NOT attempt to force the pin back through the collet.

The collet is damaged.

Return the equipment to Stryker for repair.

The pin slips in the pin collet REF 4100-125-000 while using the System 6 Small Aseptic Battery Kit REF 6127-000-000.

The adjustable pin collet REF 4100-126-000 is not installed to drive the pin properly.

Install the adjustable pin collet REF 4100-126-000. See the attachment instructions for use manual for specific attachment and accessory instructions.

The handpiece is noisy and/or vibrates.

The handpiece is damaged.

Return the equipment 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. 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 Cordless Driver Handpiece (REF 4505-000-000)

Dimensions:

139 mm [5.5 inch] height, 34 mm [1.3 inch] width, 107 mm [4.2 inch] length

Mass:

0.58 kg [1.3 lb]

Maximum Speed:

1500 rpm (nominal)

Mode of Operation:

Non-continuous Forward and Reverse Modes

Oscillate Mode

With Sagittal Saw Attachment (REF 4100-400-000)

Duty Cycle:

1 minute on/ 4 minutes off, 5 times

15 seconds on/ 15 seconds off, 5 times

10 seconds on/ 20 seconds off, 4 times

Rest Between Cycles:

2 hours

1.5 hours

0.5 hours

Applied Part(s):

The distal end of the handpiece and the attachment as defined by the manufacturer

Maximum Temperature of Applied Part(s):

Less than 51 °C [124 °F] as tested to the Product Safety Certification 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:

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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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