PD Series Maestro Attachments Instructions for Use Rev AA Dec 2019

EN

5400-210-712 Rev-AA

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, biomedical equipment technicians, and central supply/sterile processing 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. Trademarks not the property of Stryker Corporation are the property of their respective owners.

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 PD Series Maestro Attachments are intended for use with the Consolidated Operating Room Equipment (CORE™) System Maestro Pneumatic System REF 5400-200-000 and 5400-201-000, and the Sumex® Drill REF 5400-130-000. Attachments REF 5400-210-050, 5400-210-052, 5400-210-070, and 5400-210-072 only are also intended for use with the CORE Saber™ Drill REF 5400-120-000.

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User/Patient Safety WARNINGS: • Only trained and experienced healthcare professionals should use this equipment. • 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 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 equipment. • If vibration of the bur and the shank occurs, reduce pressure to avoid affecting the retaining force on the bur. Failure to comply could make it difficult to control. • 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 equipment. • When operating the handpiece, DO NOT actuate the attachment locking ring to prevent damage to the handpiece. • When inserting or removing cutting accessories or attachments, DO NOT operate 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. • When in use, attachments are applied parts. See the instructions for use supplied with the handpiece for information specific to applied parts.

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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5400-210-712 Rev-AA

Accessories (continued) Burs • 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 significantly increases 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. • Always use the appropriate length of bur with the corresponding attachment. NOTES: • Sterile cutting accessories are sterilized by irradiation. • Stryker Maestro attachments are marked with identifying letters “O,” “M,” “AM,” “R” and “RX” and are similar in length and bur exposure to similarly identified Midas Rex attachments. “O”

“M”

“AM”

“R”

“RX”

5400-210080

5400-210090

Straight Attachments 5400-210020

5400-210050

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5400-210052

5110-XXXXXX

5120-XXXXXX

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5220-XXXXXX

5400-210070

Angled Attachments 5400-210072

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5130-XXXXXX

5160-XXXXXX

5190-XXXXXX

5230-XXXXXX

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Bur Series

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• The following Stryker-approved accessories are also sold separately: DESCRIPTION

REF

3.0 mm Neuro (Match Head)

5280-107-530

2.0 mm TPS™ Tapered Side Cut Solid Carbide

5300-010-716S1

5.5 mm Round Fluted Carbide

5320-010-055

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

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 WARNINGS: • DO NOT attach or remove any component while the handpiece is running. • Monitor heavy sideloads and/or long operating periods to prevent overheating of the distal tip and body of the handpiece and/or attachment. 1. Align the pin(s) on the attachment with the small notch(es) in the handpiece connector. Press the attachment onto the handpiece until it snaps into the connector.

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5400-210-712 Rev-AA

Assembly (continued) NOTE: A two-pin attachment and a two-notch drill are illustrated for reference. Some PD Series Attachments have only one pin, for use with the single-notch Saber Drill (REF 5400-120-000). See the For Use With section. A

D A

RUN

B

Pin(s)

C

Notch(es)

D

Locking Ring

E

LOAD

B

C

E

NOTE: Ensure the attachment is secure before running the handpiece. 2. Rotate the attachment’s locking ring in the LOAD direction until the ring snaps into place. WARNING: Ensure the safety line on the shaft of the bur is hidden within the handpiece to verify the bur is properly seated. If the safety line is visible, the bur may disengage, bend, and/or eject while in use. 3. Insert the bur into the attachment until it bottoms. The safety line on the bur shaft should disappear inside the handpiece. 4. Rotate the attachment’s locking ring in the RUN direction. 5. Gently tug the bur to ensure that it is secure in the attachment.

Disassembly 1. Rotate the attachment’s locking ring in the LOAD direction until the ring snaps into place. 2. Remove the bur from the attachment. 3. Firmly pull the attachment away from handpiece to disengage.

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

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 difficult to attach or release from the handpiece.

Connectors require a breaking-in period.

Attach and detach the attachment repeatedly until connectors function smoothly.

Build-up of debris inside attachment or drill connector.

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

Attachment will not seat on handpiece.

Pin(s) and notch(es) are not lined up.

Realign pin(s) and notch(es) and push together firmly.

Attachment becomes hot.

Build-up of debris inside attachment.

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

Bur will not disengage from attachment.

Attachment locking collar is still in RUN position.

Rotate attachment locking collar to LOAD position.

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5400-210-712 Rev-AA

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:

PD Series Maestro Straight “O” Attachment (REF 5400-210-020)

Dimensions:

3.2 inch [81.3 mm] length 0.7 inch [17.1 mm] diameter

Mass:

0.14 lb [65.4 g]

Model:

PD Series Maestro Straight “M” Attachment (REF 5400-210-050)

Dimensions:

3.9 inch [98.5 mm] length 0.7 inch [17.1 mm] diameter

Mass:

0.15 lb [68.4 g]

Model:

PD Series Maestro Angled Medium “M” Attachment (REF 5400-210-052)

Dimensions:

4.1 inch [104.1 mm] length 0.7 inch [17.1 mm] diameter

Mass:

0.17 lb [76.1 g]

Model:

PD Series Maestro Straight “AM” Attachment (REF 5400-210-070)

Dimensions:

6.0 inch [151.2 mm] length 0.7 inch [17.2 mm] diameter

Mass:

0.17 lb [77.0 g]

Model:

PD Series Maestro Angled Long “AM” Attachment (REF 5400-210-072)

Dimensions:

6.1 inch [156.0 mm] length 0.7 inch [17.2 mm] diameter

Mass:

0.19 lb [84.8 g]

Model:

PD Series Maestro Straight “R” Attachment (REF 5400-210-080)

Dimensions:

10.5 inch [266.2 mm] length 0.7 inch [17.2 mm] diameter

Mass:

0.21 lb [95.7 g]

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Specifications (continued) Model:

PD Series Maestro Straight “RX” Attachment (REF 5400-210-090)

Dimensions:

16.6 inch [420.8 mm] length 0.7 inch [17.2 mm] diameter

Mass:

0.37 lb [166.8 g]

Equipment Type:

See the instructions for use supplied with the handpiece.

When used with CORE Sumex Drill (REF 5400-130-000): Mode of Operation:

Non-continuous Operation

Duty Cycle:

20 seconds on, 20 seconds off, 10 times

Rest Between Cycles:

40 minutes

When used with 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

5400-210-713 5400-210-720 5400-210-730 5400-210-750

Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210 2019-12

5400-210-712 Rev-AA

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