TPX Sagittal Saw Instructions for Use Rev AC May 2021

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700000336909 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 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.

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 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 The TPX Sagittal Saw is intended for use with the Consolidated Operating Room Equipment (CORETM) System. When used with a variety of cutting accessories, the TPX Sagittal Saw is intended for surgical procedures involving the cutting of bone and hard tissue. This includes but is not limited to Orthopedic, Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications.

Contraindications None known.

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Safety Directives 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 for each patient. Stryker, as a manufacturer, does not recommend surgical technique. • ALWAYS allow the equipment to reach the specified operation temperature range before use. See the Specifications section. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the processing instructions manual supplied with the equipment. • Upon initial receipt and before each use, inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. See the processing instructions manual supplied with the equipment. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or nitrous oxide.

For Use With This section identifies components intended to be used with the equipment to obtain a safe combination. WARNINGS: • Use only Stryker-approved equipment, unless otherwise specified. • Use of unapproved electrical equipment may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. DESCRIPTION

REF

CORE Powered Instrument Driver (console) with software version 7.0 or higher

5400-050-000

CORE 2 Console with software version 1.0 and higher

5400-052-000

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Accessories WARNINGS: • Use only Stryker-approved equipment, unless otherwise specified. • DO NOT modify any equipment without the authorization of the manufacturer. • 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. • All cutting accessories are intended for single use only. Reuse significantly increases wear on the handpiece and attachment. • Use adequate irrigation during cutting to prevent heat generation. • Upon initial receipt and before use, inspect the package for damage and 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. NOTES: • Cutting accessories are sterilized using irradiation • 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

Blades

2296-003-XXX series 2296-023-XXX series 2296-033-XXX series 5400-003-XXX series 5400-031-XXX series 5400-033-527 5400-134-XXX series

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TPX Cord

7400-004-000

TPS™ Cord

5100-004-000

TPX Handswitch

7400-009-000

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Features B

A

C A

Blade Mount

B

Cord Receptacle

C

Button

Definitions The symbols located on the equipment and/or labeling are defined in this section and in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. SYMBOL

DEFINITION Cord Alignment Mark General warning sign

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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Instructions WARNINGS: • ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section. • DO NOT attempt to insert or remove any cutting accessory while the handpiece is operating. • ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. See the Specifications section. • DO NOT apply excessive pressure, such as bending or prying with the cutting accessory. Excessive pressure may cause the components to overheat and/or bend or fracture the cutting accessory. This may cause tissue damage and/or loss of tactile control. • Before operating the handpiece, gently tug the blade to verify the blade is secure. • Before operating the handpiece, attempt to rotate the blade mount to verify the blade mount is seated properly. The blade mount should not rotate, and should be fully recessed. Failure to comply may result in excessive handpiece vibration/noise. CAUTION: During an endoscopic procedure, DO NOT introduce the handpiece through the same orifice as the endoscope.

To Attach a Cutting Accessory 1. Insert the blade into the gap in the blade mount.

2. Fully depress the button and seat the blade against the post. Release the button.

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

4. Gently tug the blade to verify the blade is secure. 5. To index the blade mount, pull out and rotate the blade mount until it snaps into the desired location. CAUTION: The blade can be safely attached 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. NOTE: The blade mount will index in 45-degree increments, or five possible locations.

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Instructions (continued) To Operate the Handpiece NOTE: See the instructions for use supplied with the appropriate console for additional information about handpiece operation. 1. Plug one end of the cord into the handpiece cord receptacle and the other end of the cord into the appropriate console cord receptacle. 2. Use the console to program the operational settings of the handpiece as required. 3. Use either a handswitch or a footswitch to operate the handpiece. NOTE: Use the console touchscreen to assign different functions to the footswitch pedals as required.

To Remove a Cutting Accessory 1. Fully depress the button. 2. Remove the blade from the handpiece.

Final Disassembly 1. Unplug the cord from the console and from the handpiece. 2. Remove cutting accessory as described above.

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Troubleshooting WARNING: DO NOT disassemble or service this equipment without the authorization of the manufacturer. 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 console fails to recognize the handpiece or displays a handpiece error message.

The console software is not compatible with the handpiece.

Contact Stryker to obtain console upgrade information.

An electrical malfunction exists.

Return the handpiece for repair.

The handpiece exhibits excessive noise and vibration during operation.

The blade is not properly installed in the handpiece.

Reinstall the blade.

The blade exhibits reduced cutting action under a light cutting load.

Normal wear of internal handpiece components.

Return the handpiece for repair.

The cutting accessory will not disengage from the handpiece.

The lock collar is not turned fully enough to release the cutting accessory.

Rotate the lock collar fully counterclockwise.

Sporadic electrical interference is experienced.

Electrical noise is present.

Turn off all electrical equipment not in use in the operating room. Relocate electrical equipment; increase spatial distance. Plug operating room equipment into different operating room outlets.

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

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

TPX Sagittal Saw (REF 7400-034-000)

Dimensions:

5.3 inch [135 mm] length 0.875 inch [22.2 mm] diameter

Mass:

0.37 lb [0.168 kg]

Speed:

25000 cpm

Excursion:

5 degree arc

Mode of Operation:

Non-continuous Operation

Duty Cycle: Blade cutting accessory REF 5400-134-XXX

Cycle Time: 10 seconds on/10 seconds off Cycle Frequency: 3 times Rest Between Cycles: 30 minutes

All other blade cutting accessories

Cycle Time: 10 seconds on/10 seconds off Cycle Frequency: 4 times Rest Between Cycles: 30 minutes

Power Supply:

Stryker CORE 2 or CORE Console 40 V (Direct Current)

Equipment Type:

Type BF Applied Part

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.)

Ingress Protection:

IPX9 Ordinary Equipment

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Environmental Conditions:

EN

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

700000715875 700000715876 700000715877 700000715878 700000715879

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

700000336909 Rev-AC

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