MD Series Attachments Instructions for Use Rev AB May 2021

EN

5100-015-735 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, 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.

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 MD Series Attachments are intended for use with the following Stryker handpieces:

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DESCRIPTION

REF

RemB® Electric Micro Drill

6400-015-000

Consolidated Operating Room Equipment (CORE™) Micro Drill

5400-015-000

Total Performance System (TPS™) Micro Drill

5100-015-000

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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 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 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 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. • DO NOT apply excessive pressure. Monitor heavy sideloads and/or long operating periods to prevent overheating of the distal tip and body of the handpiece and/or attachment. Excessive pressure may bend or fracture the cutting accessory. • 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. • Use adequate irrigation during cutting to prevent heat generation. • When in use, attachments are applied parts. See the instructions for use supplied with the handpiece for information specific to applied parts.

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5100-015-735 Rev-AB

Accessories WARNINGS: • Use only Stryker-approved system components and accessories unless otherwise specified. • DO NOT modify any system component or accessory unless otherwise specified. NOTES: • A variety of specialized attachments are available for use with the Micro Drill. Each specialized attachment is supplied with specific instructions. • For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. The following Stryker-approved accessories are sold separately: DESCRIPTION

REF

E-Type Attachment Bur Guard

5100-015-301

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. • 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.

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• DO NOT use a cutting accessory with an overall length greater than 2.25 inches [5.72 cm] with the Micro Drill attachments described in this instruction booklet. NOTE: Sterile cutting accessories are sterilized by irradiation. DESCRIPTION

REF

5.0 mm Egg Bur

0277-010-050

3.0 mm Matchhead Bur, Extended

0277-010-208

Carbide Burs

0277-010-221 0277-010-235 0277-010-421 5300-010-421 5300-010-50X series 5300-010-51X series 5300-010-70X series 5300-010-71X series 5300-010-90X series

6.1 mm Pear Bur

1608-002-005

Metal Cutting Diamond Disc

1608-006-099S4

Toe Fusion Sets

1608-010-100SX series

Resurfacing Tools

1900-010-040 1900-015-040 1900-015-025

Drill Bits, Medium

5300-010-041 5300-010-059 5300-010-063 5300-010-071

Swanson Pilot Point Burs, Medium

5300-010-13X series

Round Diamond Burs, Medium

5300-010-303 5300-010-307 5300-010-311

Dermabraders

5300-010-911 5300-010-94X series

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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5100-015-735 Rev-AB

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 NOTE: The Micro Drill handpiece may be operated with the Stryker footswitch or handswitch.

Assembly WARNING: Ensure the handpiece is off. DO NOT attach any cutting accessory or attachment while the handpiece is running. 1. Install the attachment onto the handpiece with a twisting motion until it securely snaps into place. See figure 1.

Figure 1. Attachment Installation NOTE: Ensure the attachment is secure before running the Micro Drill. Observe the small gap between the attachment and the Micro Drill housing caused by the anti-rotation pin. This gap will not hinder the function of the Micro Drill or the attachment. The gap should not be wider than 0.025 inches [0.65 mm].

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Assembly (continued) 2. Insert the cutting accessory as follows: 2. 1. Rotate the lock collar to the LOAD position. See figure 2. 2. 2. Insert the cutting accessory into the attachment with a twisting motion until it bottoms.

Figure 2. Cutting Accessory Installation 2. 3. Rotate the lock collar to the RUN position. See figure 3.

Figure 3. Cutting Accessory Locked Into Place 2. 4. Gently tug on the cutting accessory to ensure that it is locked into place. WARNING: Ensure the cutting accessory is correctly installed. A burn injury may result if the accessory is incorrectly installed and friction occurs between the accessory and the attachment.

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5100-015-735 Rev-AB

Disassembly 1. Rotate the lock collar to the LOAD position. See figure 4. 2. Pull the cutting accessory straight out of the handpiece.

Figure 4. Cutting Accessory Removal 3. Grasp the attachment and pull it away from the handpiece.

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.

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PROBLEM

CAUSE

SOLUTION

Attachment is difficult to install or remove from the handpiece.

The connector requires a break-in period.

Install and remove the attachment repeatedly until the connector functions smoothly.

Attachment will not retain the cutting accessory.

Lock collar is not fully engaged.

Rotate the collar to the LOAD position. Reinstall the cutting accessory. Fully rotate the collar to the RUN position. Gently tug on the cutting accessory to ensure it is secure.

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PROBLEM

CAUSE

SOLUTION

Handpiece will not run.

Lock collar is not fully engaged.

Fully rotate the collar to the RUN position.

Cutting accessory will not disengage from the attachment.

Lock collar is not fully disengaged.

Fully rotate the collar to the LOAD position.

Cutting accessory seizes in the attachment.

Lock collar is not fully engaged.

Rotate the collar to the LOAD position. Reinstall the cutting accessory. Fully rotate the collar clockwise to the RUN position. Gently tug on the cutting accessory to ensure it is secure.

Attachment is not properly installed into the handpiece.

Reinstall the attachment. Ensure the connection is flush to the handpiece.

Attachment runs at a gradually higher temperature over its operating life.

Attachment is beginning to wear.

Return the attachment to Stryker for evaluation and possible replacement.

Attachment heats up rapidly during use.

Debris is trapped inside the attachment.

Clean and sterilize the attachment.

Internal components of the attachment are damaged.

Return the attachment to Stryker for evaluation and possible replacement.

Attachment was improperly cleaned and sterilized.

Clean and sterilize the attachment. Comply with Dry Cycle requirements.

Attachment contains moisture and leaks fluid during use.

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5100-015-735 Rev-AB

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

MD Series Straight Attachment (REF 5100-015-250)

Dimensions:

3.4 inch [87.2 mm] length 0.8 inch [19.6 mm] diameter

Mass:

0.15 lb [69.3 g]

Model:

MD Series Angled Attachment (REF 5100-015-252)

Dimensions:

5.2 inch [130.9 mm] length 0.8 inch [19.6 mm] diameter

Mass:

0.26 lb [117.0 g]

Model:

MD Series Long Straight Attachment (REF 5100-015-270)

Dimensions:

4.3 inch [109.0 mm] length 0.8 inch [19.6 mm] diameter

Mass:

0.18 lb [80.3 g]

Model:

MD Series Long Angled Attachment (REF 5100-015-272)

Dimensions:

6.0 inch [153.5 mm] length 0.8 inch [19.7 mm] diameter

Mass:

0.28 lb [127.7 g]

Equipment Type:

See the instructions for use supplied with the handpiece.

Mode of Operation:

Non-continuous Operation

Duty Cycle:

20 seconds on/20 seconds off, 10 times

Rest Between Cycles:

30 minutes

Applied Part:

When used with handpieces, the attachments described in this manual are applied parts. For more information, see the instructions for use supplied with the handpiece.

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Specifications (continued) Maximum Temperature of Applied Part:

Environmental Conditions:

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.) 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

5100-015-718 5100-015-722 5100-015-731 5100-015-750

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

5100-015-735 Rev-AB

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