Ref 4100-XX and 4505-XX Driver Systems Instructions for Use Rev AC May 2021

4100-005-700 Rev-AC

EN

Contents

T-Latch Attachment...

Introduction... 1

9

Description... 9

Indications For Use...

1

Care Instructions... 9

Contraindications...

2

Definitions... 9

For Use With...

2

Specifications... 9

Safety Directives... 2 Sagittal Saw Attachment... 2 Description... 2 Accessories...

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Instructions... 3 Duty Cycle... 4 Locking Keyless Chucks... 4 Description... 4 Instructions... 4 Duty Cycle... 5 Keyless Drill Chucks... 5 Description... 5 Instructions... 5 Duty Cycle... 5 Chucks with Key... 6 Description... 6 Instructions... 6 Duty Cycle... 6 Wire and Pin Collets... 6 Description... 6 Instructions... 7 Duty Cycle... 7 Drill and Reamer Attachments...

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Description... 7 Instructions... 8 Duty Cycle... 8 Radiolucent Attachments... 9 Description... 9 Bur Attachments... 9 Description... 9

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, 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. NOTE: The user and/or patient should report any serious product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established. Dimensions and weights are approximate and may vary between devices. 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.

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4100-005-700 Rev-AC

Contraindications

handpiece. Upon initial receipt and before each use, inspect each component for damage. DO NOT use any equipment if damage is apparent.

None known.

For Use With The Stryker Cordless Driver and Universal Driver Attachments are intended for use with the following Stryker handpieces: DESCRIPTION

REF

System 8 Cordless Driver

4505-000-000

Cordless Driver 4

4405-000-000

Cordless Driver 3

4300-000-000

Cordless Driver 2

4200-000-000

Cordless Driver

4100-000-000 4101-000-000

CORE™ Universal Driver

5400-099-000

RemB® Electric Universal Driver

6400-099-000

TPX® Universal Driver

7400-099-000

Safety Directives

• Use only Stryker-approved equipment, unless otherwise specified. DO NOT modify any equipment without the authorization of the manufacturer. • ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section. • 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. • DO NOT reuse, reprocess, or repackage a device that is intended for single use only. Failure to comply may lead to infection or cross-infection and result in patient and/or healthcare staff injury.

Sagittal Saw Attachment Description Sagittal Saw Attachment (REF 4100-400-000)

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. • ALWAYS slide the function switch to the safe mode position when the handpiece is idle, before installing an attachment or accessory, or when passing the handpiece to another person. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the care instructions manual supplied with the 2

Length: 112.0 mm; Diameter: 22.5 mm; Weight: 172.0 g

Accessories NOTE: For a complete list of accessories, contact your Stryker sales representative. Outside the US, contact your nearest Stryker subsidiary. The following Stryker-approved accessories are sold separately: DESCRIPTION

REF

Blades

2296-003-XXX Series 2296-023-XXX Series 2296-033-XXX Series 5400-003-XXX Series 5400-134-XXX Series

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4100-005-700 Rev-AC

Instructions WARNINGS: • DO NOT attempt to insert or remove any cutting accessory or attachment while the handpiece is operating.

EN CAUTION: The blade can be safely installed in five possible cutting angle positions. ALWAYS install the blade in one of the five positions shown. Failure to comply may cause the blade to strike the handpiece during operation.

• DO NOT apply excessive pressure, such as bending or prying, with the blade. Excessive pressure may bend or fracture the blade and cause tissue damage and/or loss of tactile control. • Before operating the handpiece, gently tug the blade to verify it is secure. • Before operating the handpiece, gently rotate the blade mount to verify it is seated properly (should not rotate, fully recessed). Failure to comply may result in excessive handpiece vibration/noise and patient and/or operating room staff injury.

3. Gently rotate the blade against the post until it snaps into the desired location. If necessary, depress the button again to rotate the blade to the desired location.

NOTE: Operate Sagittal Saw Attachment with lower trigger only. Cutting efficiency is lost if both triggers are depressed to operate this attachment in the oscillate mode.

To Install a Blade 1. Insert the blade into the blade mount retaining gap.

4. To index the blade mount, pull out and slightly rotate the mount until it snaps (recesses) into the desired location. The blade mount will index in 45-degree increments or eight possible locations.

2. Depress the button to allow the blade to fully enter the gap and seat against the post, then release the button.

To Remove a Blade Depress the button and remove the blade from the blade mount.

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4100-005-700 Rev-AC

Duty Cycle

5/32 inch (4.0 mm) Locking Keyless Chuck (REF 4505-134-000)

WARNINGS: • The duty cycle for the Sagittal Saw Attachment takes precedence over the general duty cycle specified for the handpiece.

Handles wires, pins, and drill bits up to 0.156 inch (4 mm) diameter. Can be operated in forward, reverse, or oscillation modes. Length: 105 mm; Diameter: 28.5 mm; Weight: 245 g

• ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. Mode of Operation: Non-continuous HANDPIECE

BLADE

DUTY CYCLE

System 8 Cordless Driver and Cordless Driver 4

All blades

10 seconds on/ 20 seconds off, 4 times

All other handpieces

5400-134XXX series blades

10 seconds on/ 10 seconds off, 3 times

All other blades

10 seconds on/ 10 seconds off, 4 times

Rest Between Cycles: 30 minutes

Locking Keyless Chucks Description 1/4 inch (6.4 mm) Locking Keyless Chuck (REF 4505-133-000) Handles wires, pins, and drill bits up to 1/4 inch (6.4 mm) diameter. Can be operated in forward, reverse, or oscillation modes. Length: 120 mm; Diameter: 31.5 mm; Mass: 330 g

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Instructions WARNING: You must manually close the chuck jaws to secure the accessory. Operating the handpiece to automatically close the jaws on the accessory may result in injury to the user. NOTE: If the chuck is attached to the handpiece during accessory installation, rotating the chuck collar will also rotate the handpiece drive mechanism.

To Install an Accessory 1. Open the chuck jaws by holding the sleeve in one hand and turning the collar with the other hand. Hold sleeve

Turn collar

2. Insert the cutting accessory and make certain it is centered in the jaws.

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4100-005-700 Rev-AC

EN

3. Close the jaws by holding the sleeve and turning the collar until tight. The collar will move forward with one or more audible clicks. Continue turning the collar until the collar is hand-tight.

1/8 inch Keyless Drill Chuck (REF 4100-134-000) Handles wires, pins, and drill bits up to 1/8 inch (3.2 mm) diameter. Length: 103.8 mm; Diameter: 25.1 mm; Weight: 200.9 g

Hold sleeve

Instructions Turn collar

4. Tug the cutting accessory to ensure it is secure. 5. Visually verify that the cutting accessory is centered in the jaws. If the accessory has flats, make sure the jaws are centered directly on the flats. 6. Install the attachment in the handpiece.

WARNING: You must manually close the chuck jaws to secure the accessory. Operating the handpiece to automatically close the jaws on the accessory may result in injury to the user.

To Install an Accessory 1. Open the chuck jaws by holding the attachment with the collar or knurled ring in one hand and turning the collar with the other hand.

To Remove an Accessory

2. Insert the cutting accessory and make certain it is centered in the jaws.

1. Hold the sleeve in one hand and turn the collar with the other hand to open the jaws.

3. Close the jaws by holding the collar and turning the knurled ring until tight.

2. Remove the accessory.

4. Tug the cutting accessory to ensure it is secure.

Duty Cycle

5. Visually verify that the cutting accessory is centered in the jaws.

See the instructions for use supplied with the handpiece.

6. Install the attachment in the handpiece.

To Remove an Accessory

Keyless Drill Chucks

1. Hold the knurled ring in one hand and turn the collar with the other hand to open the chuck jaws.

Description

2. Remove the accessory.

1/4 inch Keyless Drill Chuck (REF 4100-133-000)

Duty Cycle

Handles wires, pins, and drill bits up to 1/4 inch (6.4 mm) diameter. Length: 113.6 mm; Diameter: 30.2 mm; Weight: 298.1 g

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See the instructions for use supplied with the handpiece.

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Chucks with Key Description 1/4 inch Keyed Chuck (REF 4100-131-000) Handles wires, pins, and drill bits up to 1/4 inch (6.4 mm) diameter. Length: 108.7 mm; Diameter: 28.7 mm; Weight: 209.0 g

4100-005-700 Rev-AC 3. Use the chuck key to close the chuck jaws. 4. Visually inspect the accessory to make sure it is centered in the chuck jaws. 5. Tug the accessory to make sure it is secure before operating the handpiece.

To Remove an Accessory 1. Use the chuck key to open the chuck jaws. 2. Remove the accessory.

Duty Cycle 5/32 inch Drill (REF 4100-132-000)

See the instructions for use supplied with the handpiece.

Handles wires, pins, and drill bits up to 5/32 inch (4 mm) diameter. Length: 83.0 mm; Diameter: 25.2 mm; Weight: 137.3 g

Wire and Pin Collets Description

1/4 inch Reamer (REF 4100-231-000) Handles wires, pins, and drill bits up to 1/4 inch (6.4 mm) diameter with low speed and high torque. Length: 116.9 mm; Diameter: 28.8 mm; Weight: 295.5 g

Wire Collet (REF 4100-062-000) Chuck style attachments are supplied with a chuck key.

Instructions

This collet holds K-wires having diameters from 0.028 – 0.071 inch (0.7 – 1.8 mm). Length: 88.6 mm; Height: 143.1 mm; Diameter: 22.9 mm; Weight: 192.8 g

To Install an Accessory 1. Use the chuck key to open the chuck jaws. 2. Insert the accessory into the center of the chuck jaws.

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4100-005-700 Rev-AC Pin Collet (REF 4100-125-000) NOTE: If the System 6 Small Aseptic Battery Kit REF 6127-000-000 will be used with CD4 Handpiece REF 4405-000-000, use the adjustable pin collet REF 4100-126-000 instead of the pin collet REF 4100-125-000. This collet holds pins having diameters from 0.078 – 0.125 inch (2.0 – 3.2 mm). Length: 88.6 mm; Height: 143.3 mm; Diameter: 23.2 mm; Weight: 191.6 g

EN 3. Depress the trigger on the handpiece and pull the handpiece and wire or pin away from the bone. NOTE: To withdraw threaded pins, squeeze the wire advance control lever and then depress the reverse trigger.

Duty Cycle See the instructions for use supplied with the handpiece.

Pin Collet (REF 4100-126-000) See the instructions for use supplied with this attachment. Pin Collet (REF 4100-225-000) See the instructions for use supplied with this attachment.

Instructions

Drill and Reamer Attachments Description Trinkle Drill (REF 4100-160-000) Accepts tools such as drill bits and automatic screwdrivers with standard Trinkle fitting. Length: 83.8 mm; Diameter: 25.0 mm; Weight: 137.7 g

To Insert a Wire or Pin 1. Load the wire or pin into the nose of the collet or back cap of the handpiece. 2. Move the safety switch out of the safety position. 3. Squeeze the wire advance control lever against the instrument to hold the wire at the desired length exposed from the distal end of the instrument.

Trinkle Reamer (REF 4100-260-000) Accepts tools such as drill bits, automatic screwdrivers and flexible reamers with standard Trinkle fitting. Utilizes low speed and high torque. Length: 107.6 mm; Diameter: 28.7 mm; Weight: 241.7 g

4. Hold the wire or pin against the bone, then depress the trigger to drive the wire or pin. 5. To obtain additional wire length for inserting, release the wire advance control and pull back the instrument. Then, squeeze the wire advance control lever and the trigger to drive more wire.

To Remove a Wire or Pin 1. Place the nose of the collet over the free end of the wire or pin, and then advance the collet as far as possible.

DHS Reamer (REF 4100-215-000) Accepts tools such as drill bits, automatic screwdrivers and flexible reamers with standard DHS fitting. Utilizes low speed and high torque. Length: 103.7 mm; Diameter: 28.7 mm; Weight: 233.7 g

2. Squeeze the control lever to grasp the wire or pin.

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EN AO® Small Drill (REF 4100-110-000) Accepts Synthes tools such as drill bits, taps and automatic screwdrivers with the appropriate snaplock shank. Length: 92.7 mm; Diameter: 25.1 mm; Weight: 169.0 g

Hudson®/Modified Trinkle Drill (REF 4100-135000) Accepts tools such as drill bits, and automatic screwdrivers with Hudson or modified Trinkle fitting. Length: 85.0 mm; Diameter: 25.1 mm; Weight: 150.8 g

4100-005-700 Rev-AC Right Angle Drive - AO Large Reamer (REF 4100-310-000) Accepts all Synthes tools with the appropriate snap-lock shank. Length: 119.0 mm; Diameter: 39.7 mm; Weight: 555.2 g

Right Angle Drive - Modified Trinkle Reamer (REF 4100-335-000) Accepts tools with modified Trinkle fitting. Length: 119.0 mm; Diameter: 39.7 mm; Weight: 543.9 g

AO Large Reamer (REF 4100-210-000) Accepts Synthes tools such as drill bits, automatic screwdrivers, and flexible reamers with the appropriate snap-lock shank. Utilizes low speed and high torque. Length: 111.0 mm; Diameter: 28.8 mm; Weight: 289.5 g

Instructions To Install an Accessory 1. Slide back the retaining collar. 2. Insert a bit or tool accessory. 3. Release the retaining collar.

Hudson/Modified Trinkle Reamer (REF 4100-235-000) Accepts tools such as drill bits, automatic screwdrivers and flexible reamers with a Hudson or modified Trinkle fitting. Utilizes low speed and high torque. Length: 104.0 mm; Diameter: 28.7 mm; Weight: 248.4 g

4. Twist the bit or tool accessory to check for proper retention before running the handpiece. To Remove an Accessory 1. Slide back the retaining collar. 2. Remove the bit or tool accessory.

Duty Cycle See the instructions for use supplied with the handpiece.

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4100-005-700 Rev-AC

EN

Radiolucent Attachments

Troubleshooting

Description

See the instructions for use supplied with the handpiece.

Right Angle Drive - Radiolucent (REF 4100-355-000) See the instructions for use supplied with this attachment. Radiolucent Adapter (REF 4100-410-000) See the instructions for use supplied with this attachment.

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

General warning sign

Bur Attachments Description 1:1 Bur Attachment (REF 4100-600-000) See the instructions for use supplied with this attachment. High Speed Bur Attachment (REF 4100-700-000) See the instructions for use supplied with this attachment.

T-Latch Attachment Description T-Latch Attachment (REF 4100-120-000)

DEFINITION

10s/10s X3

Duty Cycle – See the Sagittal Saw Attachment section. Lock – See the Locking Keyless Chucks section.

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.

See the instructions for use supplied with this attachment.

Specifications

Care Instructions

NOTE: 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.

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

Environmental Conditions See the instructions for use supplied with the handpiece.

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

4100-005-700 Rev-AC

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