The Mill Instructions for Use Rev AB Jan 2020

EN

5400-700-700 Rev-AB

Introduction

Indications For Use

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, and biomedical equipment technicians. Keep and consult this reference manual during the life of the product.

The Stryker Consolidated Operating Room Equipment (CORE™) The Mill processes appropriate-size bone particles from bone harvested from the patient.

The following conventions are used in this manual:

None known.

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Description

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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 in-service 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 product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.

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Contraindications

The mill is an electrically powered device used in the sterile field during surgery. The mill reduces bone graft material into appropriatelysized particles for surgical application. The reusable mill is powered by a console. You may use either Stryker’s CORE 2 Console (REF 5400-052-000), CORE powered instrument driver (REF 5400-050-000) or the mill powered instrument driver (REF 5400-750-000). The reusable mill cable (REF 5400-704-000) links the mill to either console. The mill accepts a sterile mill disposable that combines a cutting disc, plunger, and collection drawer. Various mill disposables generate fine, medium, or coarse bone particles.

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5400-700-700 Rev-AB

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Accessories

User/Patient Safety WARNINGS:

WARNINGS: ▪▪

Use only Stryker-approved system components and accessories, unless otherwise specified. DO NOT modify any system component or accessory.

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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.

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DO NOT reuse, reprocess, or repackage the mill disposables. The mill disposables are intended for a single use only. The mill disposables 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 mill disposables resulting in operational failure. Critical product information may be lost if the mill disposables are re-packaged. Failure to comply may lead to infection or cross-infection and result in patient and/or healthcare staff injury.

NOTE: For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

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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 the system components prior to use.

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Only trained and experienced healthcare professionals should use this equipment.

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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.

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DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or nitrous oxide.

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The Bloodborne Pathogens Standard provided by the United States Occupational Safety and Health Administration (US OSHA) requires all workers with exposure to “potentially infectious materials” wear the correct personal protection equipment and be offered immunization against hepatitis B. As an additional precaution, these workers should receive tetanus immunization and boosters when required.

The following Stryker-approved accessories are sold separately: DESCRIPTION

REF

The Mill Disposable - Medium 5400-701-000 The Mill Disposable - Fine

5400-702-000

The Mill Disposable - Coarse

5400-703-000

The Mill Cable

5400-704-000

The Mill Sterilization Case

5400-705-000

The Mill Powered Instrument Driver

5400-750-000

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5400-700-700 Rev-AB

Features

Definitions A

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 Alignment Mark

C

Run Trigger. Press to operate.

D DO NOT place fingers in the mill disposable opening. E F

B

Pinch hazard. DO NOT touch drive spindle when the mill is on.

G Fine Cut (The Mill Disposable)

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A

Mill Disposable – Consisting of a cutting disc, a plunger, and a collection drawer.

B

Run Trigger – Activates the mill. Press and hold the run trigger to sustain cutting action.

C

Drive Spindle – The spindle turns the cutting disc within the mill disposable.

D

Latch Tabs – These spring loaded tabs secure the mill disposable.

E

Release Tabs – Squeeze both tabs to release the mill disposable.

F

Cable Port – Connect the mill cable.

G

The Mill Cable – Power connection to the mill from a console.

Medium Cut (The Mill Disposable)

Coarse Cut (The Mill Disposable)

General warning sign Refer to instruction manual/ booklet

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Instructions

1.

To Set Up the System

2. Install a sterile mill disposable. Make sure the latch tabs secure the mill disposable (figure 1).

CAUTIONS:

Place the mill on a flat stable surface within the sterile field (figure 1).

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DO NOT thread or twist the push/pull-style cable connectors during installation or removal.

3. Align the marks and connect the cable to the mill (figure 1).

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When connecting or disconnecting the cable, always hold the cable by its connector.

4. Connect the cable to the console port. See the instructions for use provided with the console. If using a CORE console, use a port marked HANDPIECE PORT (figure 1).

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The cable port has an alignment mark to indicate proper cable orientation.

5. Press the ON/OFF button to turn on the console (figure 1).

NOTE: If using a CORE console, the console screen displays the instrument name as ‘The Mill’ and the cutting speed as a percentage of the maximum speed.

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5

4 3 1

Figure 1 – Set Up the System

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5400-700-700 Rev-AB

To Process the Bone Tissue

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To lubricate the interface between the collection drawer and the mill housing, the collection drawer may be removed, dipped in sterile saline solution, and reinstalled before processing the bone tissue.

1.

Place bone tissue in the mill opening (figure 2).

WARNINGS: ▪▪

ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section.

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ALWAYS follow the recommended duty cycle to prevent the equipment from overheating. See the Specifications section.

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Removal of the collection drawer from the mill disposable will expose the sharp cutting disc. Handle the mill disposable with care. The cutting disc is extremely sharp and can cause injury.

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DO NOT place fingers in the mill disposable opening.

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DO NOT probe the mill disposable with a metal object while the mill is running. Contact between the probe and cutting disc may create metal fragments that contaminate the bone particles.

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DO NOT touch the drive spindle when the mill is on. Failure to comply may result in a pinch hazard.

NOTES: ▪▪

To prevent bone from jamming in the disposable, pre-processed bone should not exceed 0.125 inch3 [2.0 cc].

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Monitor the accumulation of bone particles to avoid over-filling the collection drawer.

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Approximately 1 gram of processed bone residue will remain in the mill disposable.

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Life expectancy of the disposable varies with bone composition and resulting forces placed on the cutting disc. Replace the disposable if a reduction in cutting efficiency is experienced.

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1

Figure 2 – Insert Bone Tissue 2. Hold the plunger securely in the disposable opening (figure 3). 3. Press and hold the run trigger to operate the mill. Use firm but variable pressure on the plunger to press bone tissue against the cutting disc. Bone particles will collect in the collection drawer (figure 3).

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5400-700-700 Rev-AB

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To Disassemble the System 1.

Press the release tabs (figure 5).

2. Lift the mill disposable (figure 5).

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3. Upon completion of the procedure, properly discard the mill disposable, plunger and collection drawer (figure 5).

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Figure 3 – Process Bone Tissue

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4. Remove the collection drawer to access the bone particles (figure 4).

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4

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Figure 5 – Remove the Mill Disposable 4. Grasp the ribbed portion of the connector and gently pull the cable from the mill and the console (figure 6).

Figure 4 – Access Processed Bone

4 5. To obtain additional bone particles, install the collection drawer until it is flush with the disposable and repeat the process. Figure 6 – Remove the Mill Cable

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5400-700-700 Rev-AB

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

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

SOLUTION

The mill will not run.

No power to the console.

Reseat the power cord on the back of the console.

No power to the Mill.

Reseat the mill cable connections at the console and mill.

The equipment is damaged.

Return the mill, cable, and/or console for repair.

The mill disposable makes a clicking sound.

The mill disposable is not properly installed.

Squeeze tabs to release the mill disposable. Reinstall the mill disposable.

Bone material is wedged in the disposable.

Bone material is too large.

OPTION 1: Remove the plunger from the disposable. Retrieve the wedged bone with forceps. Reduce bone material to 0.125 inch3 [2.0 cc] or smaller then repeat cutting procedure. OPTION 2: Remove the disposable from the mill. Remove the collection drawer to expose the cutting disc. Probe through the cutting disc openings to push any wedged bone material upward away from the cutting disc. Reduce bone material to 0.125 inch3 [2.0 cc] or smaller then repeat cutting procedure.

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The mill is not cutting properly.

Bone tissue is wedged against the cutting disc.

Remove mill disposable. Use forceps to loosen and reposition the bone tissue. Install the mill disposable in the mill and resume process.

The run trigger, drive spindle or release tabs seize.

Lack of lubrication.

Lubricate the mill with sterile mineral oil.

The collection drawer does not fully close.

Debris has accumulated in the drawer slides on the bottom of the disposable.

Remove the collection drawer. Use a probe to remove the debris from the drawer slides. Insert the drawer.

Sporadic electrical interference is experienced.

Electrical noise is present.

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

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5400-700-700 Rev-AB

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Specifications Model:

CORE The Mill (REF 5400-700-000)

Dimensions:

8.125 inch [20.64 cm] height 6.0 inch [15.24 cm] diameter

Mass:

5.3 lb [2.4 kg]

Speed:

265-285 rpm

Mode of Operation: Duty Cycle: Rest Between Cycles:

Non-continuous 30 seconds on/30 seconds off, 6 times 30 minutes

Power Supply:

40 V (Direct current) Externally powered by the CORE 2 Console (REF 5400-052-000), CORE Powered Instrument Driver (REF 5400-050-000) or The Mill Powered Instrument Driver (REF 5400-750-000).

Ingress Protection:

IPX0 Ordinary Equipment

European Conformity:

Model:

CORE The Mill Disposable - Medium (REF 5400-701-000)

CORE The Mill Disposable - Fine (REF 5400-702-000)

CORE The Mill Disposable - Coarse (REF 5400-703-000)

Cutting Slots:

Twenty-four 5.0 mm

Fifty-two 3.2 mm

Eighteen 8.0 mm

European Conformity:

Model:

CORE The Mill Cable (REF 5400-704-000)

Length:

12 ft [3.7 m]

European Conformity:

Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation:

Humidity Limitation: Atmospheric Pressure Limitation:

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ES/DE/FR/IT/NL 5400-700-713 JA/ZH/KO 5400-700-722 SV/DA/FI/PT/NO 5400-700-732 PL/EL 5400-700-750

Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210 2020-01

Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210 5400-700-700 Rev-AB

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