System 8 EZout System series Instructions for Use Rev C Oct 2017

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8202-001-700 Rev-C

Contents

Instructions... 11

Introduction... 3

To Select the Plug... 11

Audience... 3

To Select the Blade... 12

Conventions... 3

To Install the Attachment and Accessories 13

Contact Information... 3

To Install the Battery Pack... 16

Indications For Use... 3

To Operate the Handpiece... 16

Contraindications... 3

To Remove the Battery Pack... 19 To Remove the Attachment and Accessories . 19

Safety Directives... 4 Definitions... 6

Care Instructions

... 20

System Overview... 6

Troubleshooting... 21

Handpiece... 6

Specifications... 24

Attachment and Accessories... 8

Handpiece... 24

Sizing Tools... 9

Accessories... 25

Battery Packs... 10

Product Safety Certification... 26

Insert Trays and Sterilization Cases . . . 10

Product Safety Compliance... 27 Electromagnetic Compatibility... 28

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8202-001-700 Rev-C

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Introduction

Contact Information

This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product.

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.

Keep and consult this reference manual during the life of the product.

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.

▪

A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage.

▪

Indications For Use The Stryker System 8 EZout Acetabular Cup Removal System is intended to cut bone and hard tissue around the bone-to-cup interface. The system incorporates a power tool (handpiece), attachment, plugs, riser rings, sizing equipment, and a variety of blades to aid in the removal of a hemispherical acetabular cup during revision of hip arthroplasty.

Contraindications None known.

A NOTE supplements and/or clarifies procedural information.

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8202-001-700 Rev-C

Safety Directives

▪

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.

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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8202-001-700 Rev-C

▪

DO NOT use this device to remove non-hemispherical cups. Attempting to remove a non-hemispherical cup could cause burns to soft tissue, bone loss, and/ or contamination of the surgical site by metal debris.

▪

DO NOT use this device to remove cemented acetabular cups. Attempting to remove cemented acetabular cups could cause overheating, burns to soft tissue, contamination of the surgical site by metal debris, and/or the ejection of metal fragments at a high velocity.

▪

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.

▪

ALWAYS lock the handpiece trigger before installing or removing attachments or accessories.

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▪

All cutting accessories are intended for single use only. Reuse significantly increases wear on the handpiece and attachment.

▪

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.

▪

Once the blade packaging is opened, discard any unused blades. Unused blades cannot be reused, reprocessed, resterilized, or repackaged.

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8202-001-700 Rev-C

Definitions

System Overview

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.

NOTE: The Stryker System 8 EZout System is a component of the Stryker System 8 Battery Powered Heavy Duty System. The System 8 EZout System includes a saw (handpiece), attachment, centering plugs, riser rings, sizing equipment, and a variety of blades.

SYMBOL

DEFINITION

Fast Mode

NOTE: For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

Standard Mode

Handpiece

Duty Cycle – See the Specifications section.

The EZout Saw is battery powered and has a trigger and a function switch.

General warning sign

2 min / 1 min / 1 min

DESCRIPTION

REF

System 8 EZout Saw

8202-000-000

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8202-001-700 Rev-C

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Function Switch

B C A

D

A

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

B

Locking Sleeve – Retains the attachment in the handpiece.

C

Flats – Align with the attachment flats during assembly.

D

Trigger – Controls the variable speed operation of the handpiece.

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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.

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Attachment and Accessories To obtain a safe combination, the EZout Saw must be used with the following Stryker-approved attachment, alignment tools, and cutting accessories. DESCRIPTION

REF

EZout Attachment

7202-100-000

EZout Centering Plugs

7202-200-0XX series

EZout Riser Rings

7202-200-1XX series

EZout Blades

7812-0XX-001K series

A

B

C

D E F G

H

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Sizing Tools

A

Flats – Align with the handpiece flats during assembly.

B

Green Ring – Indicates the amount of blade engagement while cutting.

C

Handle – Allows for blade control (up/ down and rotation) during use.

DESCRIPTION

D

Lower Rod – Rotates attachment flats for alignment during assembly.

EZout Trial Rod

7202-300-100

E

Blade – Cuts bone and hard tissue around the bone-to-cup interface.

EZout Plug Sizing Templates

7202-300-1XX series

F

Blade Latch Button – Retains the blade to the attachment.

G

Centering Plug (plug) (20) – Provides proper alignment between the attachment and the implanted cup.

H

Riser Ring (8) – Allows the plug to sit flush with the top of the implanted cup, if needed.

I

Plug Sizing Template (2) – Measures the cup liner to determine plug size.

J

Blade Sizing Tool (4) – Measures the outside diameter of the implanted cup to determine blade size.

K

The system includes several sizing tools which are used to determine the appropriate plug and blade sizes. REF

EZout Blade Sizing Tools 7202-300-0XX series

I

J

K

Trial Rod – Rotates the blade sizing tool inside the cup to determine blade size.

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8202-001-700 Rev-C

Battery Packs The handpiece accepts the following Stryker battery packs: DESCRIPTION

REF

System 8 Battery Packs

8212-000-000 8215-000-000

Stryker SmartLifeTM Battery Packs

7212-000-000 7215-000-000

Insert Trays and Sterilization Cases Upon initial receipt and before each use, the system is intended to be processed using the EZout Insert Tray. DESCRIPTION

REF

Insert Trays

7102-450-010 7102-452-010 7102-454-010 7102-458-010 7102-459-010

Stryker SmartLife Non-sterile 7126-110-000 Batteries 7222-110-000 SmartLife Aseptic Housings

7126-120-000 7222-120-000

EZout Insert Tray and Case

7102-459-000

SmartLife Transfer Shields

7126-130-000 7222-130-000

EZout Insert Tray and Container

7102-559-000

System 6 Battery Packs

6212-000-000 6215-000-000

EZout Insert Tray and Solid Bottom Container

7102-659-000

System 6 Aseptic Battery Kits

6126-000-000 6127-000-000

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8202-001-700 Rev-C

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Instructions

CORRECT

INCORRECT

To Select the Plug 34

36

36

38

2. Center the bottom of the liner into each cutout on the plug sizing template until the closest match is found. The number below the selected cutout on the template indicates the appropriate plug size.

40

1. Remove the cup liner from the implanted cup.

45

43

38

44

WARNING: Ensure that the plug size is correct for the cup to be removed. Impingement caused by incorrectly sized plugs could cause burns to soft tissue, bone loss, contamination of the surgical site by metal debris, and/or the ejection of metal fragments at a high velocity.

NOTES: ▪

The correctly sized cutout will show the least amount of gap between the cup liner and the plug sizing template.

▪

Make sure the bottom of the cup liner is centered on the plug sizing template cutout.

3. Place the selected plug into the implanted cup to verify fit.

Cup Liner Plug 43 34

36 38

45 40

Plug Sizing Template

46 41

47 42

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Cup

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8202-001-700 Rev-C

NOTES: ▪

Plug stability can be improved by trying one plug size larger or smaller, or by utilizing a riser ring.

▪

The final plug size should not be more than one size away from that initially identified by the plug sizing template unless a resurfacing cup is being removed as noted below.

▪

If a resurfacing cup is being removed, the starting plug size should be four sizes smaller than that initially indicated by the plug sizing template (e.g., if a 42 plug size was initially identified by the plug sizing template, a 38 plug size should be used).

▪

Use the femoral head component to determine plug size for implants without a liner.

To Select the Blade WARNING: Ensure that the blade size is correct for the cup to be removed. Impingement caused by incorrectly sized blades could cause burns to soft tissue, bone loss, contamination of the surgical site by metal debris, and/or the ejection of metal fragments at a high velocity. NOTE: The blade size corresponds to the outer diameter of the implanted cup. Not all cup sizes indicated by the cup manufacturer correspond to the actual outer diameter of the cup. 1. Place the selected plug (and riser ring, if needed) into the implanted cup. (See the To Select the Plug section.) 2. Select a blade sizing tool that is marked with sizes closest to that of the implanted cup’s outer diameter. 3. Place the blade sizing tool onto either end of the trial rod. 4. Place the blade sizing tool into the plug.

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8202-001-700 Rev-C

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5. Looking down on the blade sizing tool, select the section of the tool that meets or exceeds the outer edge of the implanted cup. The number on the selected section indicates the appropriate blade size. NOTE: The trial rod can be rotated to turn the blade sizing tool.

To Install the Attachment and Accessories 1. Lock the handpiece trigger. 2. Pull back the handpiece locking sleeve, and place the attachment into the handpiece.

Trial Rod Blade Sizing Tool 44

46

48 50

52

Plug NOTE: Compare the blade sizing tool to the edge of the implanted cup, not the plug. Cup

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EN

3. Rotate the attachment lower rod until the flats on the attachment align with the flats on the handpiece. Release the locking sleeve.

8202-001-700 Rev-C

5. Slide the attachment handle down to expose the blade latch button.

6. Press down on the blade latch button and slide the selected short blade into the attachment. Then release the blade latch button. 4. Gently tug the attachment to make sure the attachment is securely locked in the handpiece.

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8202-001-700 Rev-C

7. Make sure the horizontal mark at the base of the blade aligns with the attachment, indicating that the blade is loaded correctly.

EN

9. Place the selected plug into the cup. 10. Place the attachment end into the plug.

Attachment

Blade

Plug

Cup

8. Gently tug the blade to make sure the blade is securely locked in the attachment.

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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.

8202-001-700 Rev-C

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 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 oscillating 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.

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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8202-001-700 Rev-C

▪

Ensure that the plug and blade sizes are correct for the cup to be removed. Impingement caused by incorrectly sized plugs or blades could cause burns to soft tissue, bone loss, contamination of the surgical site by metal debris, and/or the ejection of metal fragments at a high velocity.

EN

▪

ALWAYS keep the device in line with the implanted cup axis and engaged with the plug while cutting. Cutting at an excessive angle may result in blade impingement, which may cause bone loss and/or contamination of the surgical site by metal debris.

CAUTIONS:

▪

DO NOT use the blade to cut through fins, spikes, or screws on the cup. Attempting to cut through these items could cause contamination of the surgical site by metal debris, and/or the ejection of metal fragments at a high velocity.

▪

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.

▪

ALWAYS pre-lubricate the attachment/plug connection with saline prior to use, and irrigate throughout the cutting process to prevent overheating.

▪

▪

DO NOT apply excessive pressure, such as bending, prying, or excessive twisting, with the device. Excessive pressure or twisting may bend or fracture the blade or attachment and result in tissue damage, loss of tactile control, and/or the ejection of metal fragments at a high velocity.

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. Remove any screws from the implanted cup. 2. Pre-lubricate the attachment/plug connection with saline.

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8202-001-700 Rev-C

NOTE: See the Function Switch section for mode descriptions.

WARNINGS:

3. Slide the handpiece function switch to the desired mode position.

▪

ALWAYS use care when removing the blade as it may be hot.

4. Depress the pressure-sensitive trigger to operate the handpiece.

▪

DO NOT bend, pry, or break bone to remove the cup.

5. While irrigating, continually rotate the attachment handle back and forth while engaging the blade. Do not plunge the blade into the bone without rotating the attachment handle.

NOTES: ▪

Ensure full cutting with the short blade prior to cutting with the long blade.

▪

If the cup is still attached after cutting with the long blade, use other methods to cut the final portion of bone.

NOTE: It is not necessary to rotate the handpiece along with the attachment. 6. The blade is fully extended when the green ring is flush with the top of the attachment handle. CORRECT

INCORRECT

7. When you are ready to switch to the long blade, lock the handpiece trigger. 8. Press down on the blade latch button and remove the short blade from the attachment.

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9. Slide the selected long blade into the attachment. Then release the blade latch button.

To Remove the Attachment and Accessories

10. Gently tug the blade to make sure the blade is securely locked in the attachment.

WARNING: ALWAYS use care when removing the blade as it may be hot.

11. Repeat steps 1-6.

To Remove the Battery Pack

1. Lock the handpiece trigger. 2. Press down on the blade latch button and remove the blade from the attachment.

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

3. Remove the plug from the removed cup. 4. If a riser ring has been installed, pull to remove it from the base of the plug.

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5. Pull back the handpiece locking sleeve, and remove the attachment from the handpiece.

8202-001-700 Rev-C

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

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