TPX Handswitch Instructions for Use Rev AC March 2020

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700000336908 Rev-AC

Introduction This instructions for use manual contains information intended to ensure the safe, effective and compliant use of your product.

Audience 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.

Conventions 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.

Contact Information For additional information, including safety information, inservice 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.

Indications For Use The TPX Handswitch is intended for use with the Consolidated Operating Room Equipment (CORETM) System and specific TPX handpieces. The TPX Handswitch is attached to the handpiece and allows direct operation of the handpiece. See the For Use With section.

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Contraindications None known.

For Use With This section identifies components intended to be used with the equipment to obtain a safe combination. WARNING: Use only Stryker-approved components and accessories. Failure to comply may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. The TPX Handswitch is intended for use with the following Stryker system components: SYSTEM

HANDPIECE

REF

TPX

Micro Drill

7400-015-000

Oscillating Saw

7400-031-000

Sagittal Saw

7400-034-000

Reciprocating Saw

7400-037-000

XL Oscillating Saw

7400-131-000

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Safety Directives 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. • The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique for each patient. Stryker, as a manufacturer, does not recommend surgical technique. • 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 each use, operate the equipment and inspect each component for damage. DO NOT use any equipment if damage or excessive wear is apparent. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the processing instructions manual supplied with the handpiece.

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Features A

B

C

A

Finger Rest

B

Safety Switch

C

Handswitch Band

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 Operate Handpiece Position (UNLOCK) Deactivate Handpiece Position (LOCK) Handpiece/Cord Alignment Mark General warning sign

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Instructions WARNINGS: • ALWAYS set the safety switch to the LOCK position while the handpiece is idle, when passing the handpiece to another person, or before inserting or removing a cutting accessory or attachment. • DO NOT press the pedal of a connected footswitch while the safety switch is set to the LOCK position. An accidental pedal press will override the LOCK position and activate the handpiece.

To Install the Handswitch 1. Make sure the cord is not connected to the handpiece. 2. Completely retract the finger rest. 3. Set the safety switch to the LOCK position. 4. Make sure the handswitch is installed onto the handpiece before the cord. 5. Align the alignment hole on the handswitch with the alignment mark on the connector end of the handpiece. Slide the handswitch band over the end of the handpiece until the handswitch band is flush with the handpiece connector. See Figure 1. 6. Insert the cord into the handpiece connector. See Figure 2. NOTES: • An audible click is produced when connection with the handswitch and handpiece is successfully engaged. • The cord will not seat properly if the handswitch band is not flush with the handpiece connector.

Figure 1 – Insert the handswitch to the handpiece

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Figure 2 – Insert the cord to the handpiece

To Operate the Handswitch WARNING: ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section. NOTE: See the instructions for use supplied with the handpiece for information about handpiece operation. 1. Adjust the length of the finger rest so that the handpiece can be held like a pencil. NOTE: When using the handswitch with a TPX Oscillating Saw or TPX XL Oscillating Saw, fully extend or fully retract the finger rest to clear the handpiece protrusion.

Figure 3 – Extend finger rest 2. Install the cutting accessory into the handpiece. 3. Set the safety switch to the UNLOCK position. 4. Depress the lever to control the variable speed of the handpiece. NOTE: The maximum handpiece speed is selected from the console.

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Instructions (continued) To Remove the Handswitch 1. Completely retract the finger rest. 2. Set the safety switch to the LOCK position. 3. Remove the cutting accessory from the handpiece. 4. Remove the cord from the handpiece connector. CAUTION: DO NOT pull back on the lever when removing the handswitch from the handpiece. 5. Hold the distal end of the handpiece. Grasp the handswitch band and slide the handswitch off of the handpiece.

Figure 4 – Remove handswitch

Processing Instructions For processing instructions and disposal/recycle information, see the processing 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 handswitch does not operate.

The handswitch is not properly seated on the handpiece.

Reseat the handswitch on the handpiece.

The safety switch is in the LOCK position.

Set the safety switch to the UNLOCK position.

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

TPX Handswitch REF 7400-009-000

Dimensions:

6.1 inch [155 mm] length 0.91 inch [23 mm] diameter

Mass:

0.16 lb [0.073 kg]

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 TR

700000715850 700000715851 700000715852 700000715853 700000715854

Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210 2020-03

700000336908 Rev-AC

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