TPX IL Oscillating Saw Instructions for Use Rev AC May 2021

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700000336915 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 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 XL Oscillating Saw is intended for use with the Consolidated Operating Room Equipment (CORE™) System. When used with a variety of cutting accessories, the TPX XL Oscillating 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. • 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

0296-031-XXX series 0277-031-XXX series

Oscillating Saw Adaptor Allen Wrench

1322-000-000

TPS™ Cord

5100-004-000

TPX Cord

7400-004-000

TPX Handswitch

7400-009-000

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Features B

A

C

A

Blade Mount

B

Cord Receptacle

C

Tab

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. • ALWAYS allow the equipment to reach the specified operation temperature range before use. See the Specifications section. CAUTION: During an endoscopic procedure, DO NOT introduce the handpiece through the same orifice as the endoscope.

To Install a Flat and Crescentic Blade Attachment CAUTION: The blade must be fully seated against screw. 1. Use the Allen wrench to loosen the retaining screw. Rotate the retaining screw counterclockwise. See Figure 1.

Figure 1 – Turn counterclockwise 2. Install the blade under the retaining screw oriented to interlock with the tab. See Figure 2.

Figure 2 – Install the blade

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3. Firmly tighten the retaining screw with the Allen wrench. Rotate the retaining screw clockwise. See Figure 3.

Figure 3 – Turn clockwise

To Install an Intra-Oral Blade Attachment NOTE: Place retaining screw in a safe place so it will not become lost. 1. Use the Allen wrench to remove the retaining screw. Rotate the retaining screw counterclockwise. See Figure 4. Figure 4 – Rotate retaining screw counterclockwise 2. Hand-tighten the blade then insert the Allen wrench through the hole for additional leverage while rotating the blade clockwise until secure. See Figure 5.

Figure 5 – Insert wrench and turn clockwise

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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.

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

SOLUTION

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.

Blade does not oscillate.

Blade not seated properly.

Reseat blade.

User placing excessive pressure on blade by prying with it.

Release pressure. Allow handpiece and blade to do the work.

Blade not fully seated.

Reseat blade.

Retaining screw is loose.

Tighten retaining screw.

Handswitch operation inhibited by large mid-section of handpiece.

Fully extend or fully retract finger rest.

Blade retained but loose.

Handpiece will not reach full speed with handswitch.

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PROBLEM

CAUSE

SOLUTION

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 XL Oscillating Saw (REF 7400-131-000)

Dimensions:

6.41 inch [163 mm] length 0.875 inch [22.2 mm] diameter

Mass:

0.48 lb [0.22 kg]

Speed:

20,000 CPM

Excursion:

8-degree arc

Mode of Operation:

Non-continuous Operation

Duty Cycle:

10 seconds on/20 seconds off, 4 times

Rest Between Cycles:

30 minutes

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.)

Power Supply:

Stryker CORE 2 or CORE Console 40 V (Direct Current

Ingress Protection:

IPX9 Ordinary Equipment

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

700000715855 700000715856 700000715857 700000715858 700000715859

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

2021-05

700000336915 Rev-AC

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