Drill Attachments REF 5450-040-XXX Series Instructions for Use Rev AB May 2021

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5450-040-700 Rev-AB

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. For additional information, especially safety information, or inservice training, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. NOTE: The user and/or patient should report any serious productrelated incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.

Indications For Use See the instructions for use supplied with the handpiece.

Contraindications See the instructions for use supplied with the handpiece.

For Use With This section describes system components that must be used with the equipment described in this manual to create a safe and effective system.

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DESCRIPTION

REF

S2 Drill (handpiece)

5450-400-000

Burs (cutting accessories)

5540-XXX-XXX series

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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. For processing instructions, see the care instructions manual supplied with the handpiece. • 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. For inspection criteria, see the care instructions manual supplied with the handpiece. • 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.

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5450-040-700 Rev-AB

Accessories This section describes system components that may be ordered to replace original equipment that is damaged, worn, or must be replaced. This section may also contain optional components used with the system. WARNINGS: • Use only Stryker-approved system components and accessories, unless otherwise specified. • DO NOT modify any system component or accessory, unless otherwise specified. • 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. • 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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DESCRIPTION

REF

Irrigation Clips

5450-040-XXX series

Burs

5540-XXX-XXX series

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If the following symbol is on the device label, the device meets the stated criteria: This device contains the following substance(s) defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt; CAS No. 7440-48-4; EC No. 231-158-0. Current scientific evidence supports the position that medical devices manufactured from cobalt alloys or stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.

Features Straight Attachment NOTE: Straight Irrigating Attachment REF 5450-040-001 and Irrigation Clip REF 5450-040-011 are illustrated for reference. E

D A

B C

A

Stripe

B

Notch (irrigating attachment only)

C

Tip

D

Irrigation Clip (irrigating attachment only)

E

Applied Part – The attachment and the irrigation clip (as defined by the Product Safety Certification standards listed in the Specifications section of the instructions for use supplied with the console.)

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Angled Attachment NOTE: Angled Irrigating Attachment REF 5450-040-003 and Irrigation Clip REF 5450-040-013 are illustrated for reference.

F E A B C D

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A

Lock Collar

B

Stripe

C

Notch (irrigating attachment only)

D

Tip

E

Irrigation Clip (irrigating attachment only)

F

Applied Part – The distal end of the attachment and the irrigation clip (as defined by the Product Safety Certification standards listed in the Specifications section of the instructions for use supplied with the console.)

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Definitions Symbols 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

10 min/ 1 min X 6

LOCATION

DEFINITION

Attachment

Lock

Attachment

Direction of rotation

Attachment

Unlock

Handpiece

Alignment mark

Attachment

Duty cycle (See the Specifications section.)

Labeling

General warning sign

Colors Cutting accessory labels are marked with color to facilitate cutting accessory selection. To select an appropriate cutting accessory, match the colored mark on the cutting accessory label with the colored stripe on the attachment.

The colors are defined as follows: COLOR

DEFINITION

Yellow

5540-XXX-XXX series cutting accessories must be used with 5450-040-XXX series attachments.

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Instructions To Install and Remove a Straight Attachment and Cutting Accessory WARNING: DO NOT attempt to install or remove an attachment or cutting accessory while operating the handpiece. 1. Align the unlock symbol with the mark on the handpiece, and slide the attachment onto the handpiece until it snaps into place.

2. For irrigating attachments only, slide the irrigation clip onto the attachment until it snaps into a row of notches.

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WARNING: ALWAYS select an appropriate cutting accessory by matching the colored stripe on the attachment with the colored mark on the cutting accessory label, and/or reviewing the attachment part numbers listed in the For Use With section of the cutting accessory label. 3. Insert the cutting accessory through the attachment until it engages with the handpiece.

WARNING: ALWAYS install the cutting accessory between the minimum and maximum exposure. When aligned with the tip of the attachment, the marks on the cutting accessory shaft indicate the exposure: • The mark next to the number 1 represents the minimum exposure. • The mark next to the highest number, typically the number 3 or 5, represents the maximum exposure. 4. Push, pull, or rotate the cutting accessory to the preferred exposure.

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5. Rotate the attachment to the lock position to secure the attachment and cutting accessory onto the handpiece.

WARNING: ALWAYS gently tug the attachment and the cutting accessory to verify they are secure. 6. Gently tug the attachment and the cutting accessory to verify they are secure. WARNING: DO NOT let the bur come into contact with the irrigation clip. During operation, metal shavings could detach from the equipment and fall into the surgical site. 7. For irrigating attachments only, connect the irrigation tubing and adjust the irrigation clip for optimum performance.

WARNING: For straight attachments only, ALWAYS remove the cutting accessory before removing the attachment from the handpiece. 8. To remove the attachment and cutting accessory from the handpiece, perform the installation steps in reverse order.

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To Install and Remove an Angled Attachment and Cutting Accessory WARNING: DO NOT attempt to install or remove an attachment or cutting accessory while operating the handpiece. 1. Align the unlock symbol with the mark on the handpiece, and slide the attachment onto the handpiece until it snaps into place.

2. Rotate the attachment to the lock position to secure the attachment onto the handpiece.

3. For irrigating attachments only, slide the irrigation clip onto the attachment until it snaps into a row of notches.

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WARNING: ALWAYS select an appropriate cutting accessory by matching the colored stripe on the attachment with the colored mark on the cutting accessory label, and/or reviewing the attachment part numbers listed in the For Use With section of the cutting accessory label. 4. Insert the cutting accessory until it engages with the attachment.

WARNING: ALWAYS install the cutting accessory between the minimum and maximum exposure. When aligned with the tip of the attachment, the marks on the cutting accessory shaft indicate the exposure: • The mark next to the number 1 represents the minimum exposure. • The mark next to the highest number, typically the number 3 or 5, represents the maximum exposure. 5. Push, pull, or rotate the cutting accessory to the preferred exposure.

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6. Rotate the lock collar to the lock position to secure the cutting accessory in the attachment.

WARNING: ALWAYS gently tug the attachment and the cutting accessory to verify they are secure. 7. Gently tug the attachment and the cutting accessory to verify they are secure. 8. For irrigating attachments only, connect the irrigation tubing and adjust the irrigation clip for optimum performance.

9. To remove the attachment and cutting accessory from the handpiece, perform the installation steps in reverse order.

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

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Troubleshooting WARNING: DO NOT disassemble or service this equipment, unless otherwise specified. 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 attachment is difficult to install or remove from the handpiece.

The unlocked symbol is not aligned with the installation alignment mark.

Align the unlocked symbol with the installation alignment mark.

The handpiece and/or attachment contains a build-up of debris.

Clean and sterilize the equipment. See the care instructions manual supplied with the handpiece.

The attachment is damaged or deformed.

Replace the attachment.

The attachment interface on the handpiece is damaged.

Return the handpiece to Stryker for repair.

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PROBLEM

CAUSE

ACTION

The attachment will not rotate to the locked position.

The attachment is not fully installed onto the handpiece.

Slide the attachment onto the handpiece until you feel the attachment snap into place.

The attachment interface on the handpiece is damaged.

Return the handpiece to Stryker for repair.

The cutting accessory is not fully snapped into the handpiece.

With the attachment rotated to the unlocked position, insert and rotate the cutting accessory until you feel the cutting accessory snap into place.

The handpiece is damaged.

Return the handpiece to Stryker for repair.

The attachment and cutting accessory are still secured in the locked position.

Fully rotate the attachment to the unlocked position.

The attachment is damaged or deformed.

Replace the attachment.

The handpiece is damaged.

Return the handpiece to Stryker for repair.

The attachment or handpiece does not retain the cutting accessory.

The cutting accessory will not disengage from the attachment.

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Specifications CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. Model:

4.0 cm Straight Attachment (REF 5450-040-000)

Dimensions:

64.6 mm length 17.8 mm diameter

Mass:

0.028 kg

Model:

4.0 cm Straight Irrigating Attachment (REF 5450-040-001)

Dimensions:

64.6 mm length 17.8 mm diameter

Mass:

0.028 kg

Model:

4.0 cm Angled Attachment (REF 5450-040-002)

Dimensions:

123.0 mm length 17.0 mm diameter

Mass:

0.081 kg

Model:

4.0 cm Angled Irrigating Attachment (REF 5450-040-003)

Dimensions:

123.0 mm length 17.0 mm diameter

Mass:

0.081 kg

Mode of Operation:

Non-continuous

Duty Cycle:

10 minutes on/1 minute off, 6 times

Rest Between Cycles:

30 minutes

Maximum Temperature of Applied Part:

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Less than 51 °C [124 °F] (Maximum surface temperature as tested to the standards listed under Product Safety Certification in the instructions for use supplied with the console.)

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Environmental Conditions:

EN

Operation

Storage and Transportation

Temperature Limitation: Humidity Limitation: Atmospheric Pressure Limitation:

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

5450-040-710 5450-040-720 5450-040-730 5450-040-750

Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210 2021-05

5450-040-700 Rev-AB

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