U Series Elite Attachments Instructions for Use Rev AB May 2021

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5100-410-740 Rev-AB

Introduction This instructions for use manual contains information intended to ensure the safe, effective and compliant use of your product. This manual is intended for 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, including safety information, inservice training, or current literature, 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 The U Series Elite Attachments are intended for use with the Consolidated Operating Room Equipment (CORE™) and Total Performance System (TPS™) U Series Drills REF 5400-100-000, 5400-110-000, 5100-010-000, and 5100-100-000.

User/Patient Safety WARNINGS: • Only trained and experienced healthcare professionals should use this equipment.

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• Before using any system component or any component compatible with this system, read and understand the instructions. Pay particular attention to the important WARNING information. Become familiar with the system components prior to use. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the care instructions manual supplied with the handpiece. • The U Series Elite and SD/PD attachments are not intended for aggressive or heavy cutting. The bur may be difficult to control during aggressive cutting and patient injury could result. If vibration of the bur and the shank occurs, reduce pressure to avoid affecting the retaining force on the bur. • 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 for inspection criteria. • When operating the handpiece, DO NOT actuate the attachment or handpiece collar. Actuation may suddenly stop and/or overheat the handpiece. • DO NOT attempt to insert or remove any cutting accessory or attachment while the handpiece is operating. • Monitor heavy sideloads and/or long operating periods to prevent overheating of the distal tip and body of the handpiece and/or attachment. • 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. • When in use, attachments are applied parts. See the instructions for use supplied with the handpiece for information specific to applied parts. • Use adequate irrigation during cutting to prevent heat generation.

Accessories WARNINGS: • Use only Stryker-approved system components and accessories unless otherwise specified. • DO NOT modify any system component or accessory unless otherwise specified.

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5100-410-740 Rev-AB

Burs

5

2 4

1

2

3

1

• 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. • All cutting accessories are intended for single use only. Reuse will significantly increase the wear on the handpiece and attachment. • DO NOT reuse, reprocess, or repackage a single use device. A single use device is intended for a 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 serious risk of contamination and may compromise the structural integrity of the single use device resulting in operational failure. Critical product information may be lost if the single use device is repackaged. Failure to comply may lead to infection or crossinfection and result in patient and/or healthcare staff injury. NOTES: • Sterile cutting accessories are sterilized by irradiation. • Use ONLY Stryker Elite burs with these attachments. Elite burs can be installed in the attachments at several different bur exposures. Compare the incremental marks on the bur shaft to the tip of the Elite attachment to determine the exposure.

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

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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

RUN

Operate Position

LOAD

Insert/Remove Position General warning sign

Instructions Assembly WARNING: DO NOT attach any component while the handpiece is running. 1. Rotate the handpiece collar until the marker is aligned with LOAD.

N

RU

D

LOA

CT

EJE

2. Place the attachment on the handpiece. Push firmly and twist until it is seated. Tug to make sure it is secure. N

RU

LOAD CT EJE

RUN

LOAD

3. Rotate the handpiece collar to the RUN position. N

RU

D

LOA

CT

EJE

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5100-410-740 Rev-AB

Assembly (continued) 4. Rotate the attachment’s locking collar to the LOAD position.

RUN

D

LOA

5. Insert the bur with a twisting motion to the desired exposure. The bur is properly positioned when you feel it click into place. RUN

LOAD

WARNING: If the bur is not secure, it can drop out of the attachment. 6. Rotate the attachment’s locking collar to the RUN position. Tug while twisting the bur to make sure it is secure.

RUN

D

LOA

Disassembly 1. Rotate the attachment’s locking ring to the LOAD position to release the bur. 2. Rotate the handpiece collar to EJECT to release the attachment. N

RU

LOAD

T

EJEC

RUN

LOAD

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

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

SOLUTION

Attachment will not seat on handpiece.

Handpiece collar is not in LOAD position.

Rotate collar to LOAD position and assemble attachment.

Bur will not lock in attachment.

Bur is not properly retained.

Insert bur to at least the exposure line marked 5. Reinsert bur at slightly different rotations until you feel it click into position.

Handpiece will not run.

Handpiece collar is not in RUN position.

Rotate collar to RUN position.

Attachment does not release from handpiece when collar is rotated to EJECT.

Attachment’s locking collar is not in RUN position.

Rotate attachment’s locking collar to RUN position.

Build-up of debris.

Clean debris from the attachment and front of handpiece. See the care instructions manual supplied with the handpiece.

Bur does not release from attachment.

Attachment’s locking collar is still in RUN position.

Rotate attachment’s locking collar to LOAD position.

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Specifications WARNING: ALWAYS check any documentation that accompanies attachments and/or cutting accessories for special duty cycle and usage instructions.

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Model:

U Series Elite Straight Medium Attachment (REF 5100-010-450)

Dimensions:

4.2 inch [106.7 mm] length 0.8 inch [20.3 mm] diameter

Mass:

0.12 lb [54.1 g]

Model:

U Series Elite Medium Angled Attachment (REF 5100-010-452)

Dimensions:

5.6 inch [142.3 mm] length 0.8 inch [20.3 mm] diameter

Mass:

0.17 lb [78.8 g]

Model:

U Series Elite Straight Long Attachment (REF 5100-010-470)

Dimensions:

5.8 inch [147.0 mm] length 0.8 inch [20.3 mm] diameter

Mass:

0.13 lb [59.0 g]

Model:

U Series Elite Long Angled Attachment (REF 5100-010-472)

Dimensions:

7.2 inch [182.0 mm] length 0.8 inch [20.3 mm] diameter

Mass:

0.18 lb [83.8 g]

Model:

U Series Elite Straight Extra Long Attachment (REF 5100-010-480)

Dimensions:

6.8 inch [171.8 mm] length 0.8 inch [20.3 mm] diameter

Mass:

0.14 lb [62.6 g]

Model:

U Series Elite Extra Long Angled Attachment (REF 5100-010-482)

Dimensions:

8.2 inch [207.5 mm] length 0.8 inch [20.3 mm] diameter

Mass:

0.19 lb [87.2 g]

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Model:

U Series Elite Straight Extra Long Plus Attachment (REF 5100-010-490)

Dimensions:

9.0 inch [228.2 mm] length 0.8 inch [20.3 mm] diameter

Mass:

0.16 lb [70.7 g]

Equipment Type:

See the instructions for use supplied with the handpiece.

When used with CORE U-Drill (REF 5400-100-000): Mode of Operation:

Non-continuous Operation

Duty Cycle:

20 seconds on/20 seconds off, 10 times

Rest Between Cycles:

40 minutes

When used with CORE UHT Drill (REF 5400-110-000): Mode of Operation:

Non-continuous Operation

Duty Cycle:

20 seconds on/20 seconds off, 10 times

Rest Between Cycles:

1 hour

When used with any other Stryker handpiece: See the instructions for use supplied with the handpiece. Applied Part:

When in use, attachments are applied parts. For more information, see the instructions for use supplied with the handpiece.

Maximum Temperature of Applied Part:

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

Environmental Conditions:

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

5100-410-710 5100-410-722 5100-410-730 5100-410-751

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

5100-410-740 Rev-AB

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