Linvatec CoolFlex High Speed Drill Instruction for Use

Table of Contents 1.0

INTRODUCTION 1.1

Operating Principle... 1

1.2

Indications for Use... 1

1.3

Intended Use... 1

1.4

Contraindications... 1

1.5

2.0

Page

Warnings and Precautions... 2 1.5.1

Warnings... 2

1.5.2

Precautions... 4

1.6

Environmental Directives... 5

1.7

Product Photographs and Drawings... 5

1.8

Symbol Definitions... 5 1.8.1

Product Symbols... 5

1.8.2

Warnings and Information Symbols... 6

SYSTEM INSTALLATION AND OPERATION 2.1

2.2

Product Description... 8 2.1.1

Handpiece Description... 8

2.1.2

Tubing Sets Description... 9

Assembly/Installation Instructions...11 2.2.1

Bur Guard Installation...11

2.2.2

Neuro Guard Installation... 12

2.2.3

Tubing Set Installation... 14

2.2.4

Handpiece Adjustment... 17

2.3

Operating Instructions... 18

2.4

Preoperative Functional Test... 19

3

Table of Contents 3.0

MAINTENANCE 3.1

3.2

4.0

Cleaning Information... 21 3.1.1

Warnings, Precautions and Notes... 21

3.1.2

Manual Cleaning Instructions... 21

Sterilization Information... 22 3.2.1

Warnings, Precautions and Notes... 22

3.2.2

Sterilization Instructions... 23

3.3

Troubleshooting... 24

3.4

Maintenance Schedule... 25

TECHNICAL SPECIFICATIONS 4.1

Product Technical Specifications... 26 4.1.1

4.2

4.3

5.0

Page

Handpiece... 26

Product Environmental Requirements... 27 4.2.1

Environmental Technical Specifications... 27

4.2.2

Electromagnetic Requirements... 27

Accessories... 28

CUSTOMER SERVICE 5.1

Assistance and Repair... 29

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1.0 INTRODUCTION It is recommended that personnel study this manual before attempting to operate, clean, or sterilize this or associated equipment. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Service intervals, as listed in Section “3.4 Maintenance Schedule”, are required to keep the equipment at its optimum operating performance.

1.1 Operating Principle The CoolFlex High Speed Drill is electrically powered by the surgical console to provide high speed, rotary force to a bur for bone resection. It incorporates an integral angling capability that allows the surgeon to change the angle between the main handpiece body and the bur guard from 0° to 20° without the use of a separate angle attachment. The CoolFlex High Speed Drill is controlled by using a footswitch connected to the surgical console. Tubing sets may be connected to the CoolFlex High Speed Drill to provide cooling for the handpiece housing and irrigation to the surgical site. A separate bur guard is attached to the CoolFlex High Speed Drill to support the cutting bur. Consult the associated ConMed Linvatec surgical console instruction manual prior to operating this equipment.

1.2 Indications for Use The CoolFlex High Speed Drill, and its accessories, perform resection of soft tissue and bone. The fields of application include: Otolaryngology, Neurological Surgical, Orthopedic and Spinal surgical procedures.

1.3 Intended Use Same as Indications for Use above.

1.4 Contraindications None. 5

1.5 Warnings and Precautions Do not bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or even death to the patient.

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The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully. WARNING: A warning contains critical information regarding serious ! adverse reactions and potential safety hazards that can occur in proper use or misuse of the equipment. Failure to observe the information or procedures presented in a Warning may result in injury or other serious adverse reactions to the patient and/or surgical staff. PRECAUTION: A precaution contains instructions for any special care ! to be exercised by the practitioner for the safe and effective use of the equipment. Failure to observe the information or procedures presented in a Precaution may result in damage to the equipment. NOTE: A note is added to provide additional focused information. This information has no critical effect on the patient or equipment.

1.5.1 Warnings

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1.

Eye protection is recommended when operating equipment. Eye injury may result.

2.

It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories.

3.

Do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering.

4.

Do not use equipment in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking.

5.

Do not use sterile equipment beyond the expiration date listed on the label. Sterility of the product cannot be assured beyond the expiration date.

6.

Do not excessively bend or kink the handpiece cord. Always inspect cords for signs of excessive wear or damage, or bent, broken or missing pins within the connector(s). If any wear or damage is found, discontinue 6

use and replace handpiece immediately. Using a damaged power cord could possibly cause injury. 7.

Handpieces are supplied non-sterile. Clean and sterilize prior to each use.

8.

Do not contact the moving parts on the handpieces. Injury to the operator may occur.

9.

Continually check handpiece for overheating. If overheating is sensed, immediately discontinue use and return equipment for service. Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.

10. While handpiece is not in use do not place on patient/surgical drapes. Place handpiece on mayo stand. 11. Do not immerse the equipment in fluids. Immersion may render the device inoperable. 12. Failure to follow the specified service interval could result in reduced instrument performance or overheating of the ! handpiece. Overheating can lead to possible burn injury to the patient or medical personnel. Rotation of handpiece usage per day will assist with proper performance. (Refer to section “3.4 Maintenance Schedule”). 13. Do not attach, insert or remove accessories or attachments while the handpiece is operating. Injury to the operator and/or damage to the equipment may occur. Place the handpiece safety mechanism in the “safe” position prior to installation or removal of items. 14. Avoid contact with cutting tip of blade or bur when locking into handpiece. Tips are sharp and may cause injury. 15. After use blades, burs and tubing sets may be a potential biohazard and should be handled and disposed in accordance with acceptable medical practice and applicable local and national requirements. 16. Do not use burs for plunge cutting. Injury or damage may occur. 17. Disposable blades and burs are supplied sterile and are for single-use only. Do not resterilize or reuse. The ability to effectively clean and re-sterilize these single use devices has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of the devices. 7

1.5.2 Precautions

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1.

United States Federal law restricts sale of this device to or on the order of a physician.

2.

This device should only be used in compliance with its intended use.

3.

Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it immediately for service.

4.

Use only associated ConMed Linvatec approved equipment and accessories. Using unapproved accessories may result in improper operation, and may result in non-compliance to medical standards.

5.

The warranty becomes void and the manufacturer is not liable for direct or resulting damage if: • The device or the accessories are improperly used, prepared or maintained; • The instructions in the manual are not adhered to; • Non-authorized persons perform repairs, adjustments or alterations to the device or accessories.

6.

There are no user-serviceable parts inside. No modification of this equipment is allowed.

7.

Prior to each use, perform the following: • Ensure all accessories are correctly and completely attached. (Refer to section “2.2 Assembly/Installation Instructions”). • Perform the required Preoperative Functional Tests for the equipment and accessories. (Refer to section “2.4 Preoperative Functional Test”).

8.

Clean and sterilize all equipment and associated accessories according to instructions for use. (Refer to section “3.1 Cleaning Information” and section “3.2 Sterilization Information”).

9.

Handpieces are factory sealed. Do not disassemble or lubricate, as this may void the warranty.

10. Always inspect for bent, dull or damaged blades or burs before each use. Do not attempt to straighten or sharpen. Do not use if damaged. 11. After each use, thoroughly clean the handpiece, attachments and accessories. (Refer to section “3.0 MAINTENANCE”). 12. Do not stall handpieces, damage can occur. 13. Do not handle the handpiece by the cord. Do not pull on the cord to remove it from the surgical console. Damage can occur. 8

14. Cooling for the handpiece body is recommended at all times. When using the E9414 Tubing Set, the tubing line MUST be fully primed or the handpiece will overheat, which will cause damage to the handpiece (see “E9414 Tubing Set with Recirculation only:” on page 14 for information on priming the tubing set).

1.6 Environmental Directives WEEE Directive [2002/96/EC] on Waste Electrical and Electronic Equipment. This statement only applies to European countries with regard to the Waste Electrical and Electronic Equipment (WEEE) European Directive. The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your medical equipment at the end of its useful life for recycling, please contact ConMed Linvatec.

1.7 Product Photographs and Drawings The pictures in this manual are for reference only. Items shown may not represent the actual product. However, procedural steps are identical, unless otherwise specified. When necessary, the actual pictures will be represented.

1.8 Symbol Definitions 1.8.1 Product Symbols Lock Unlock

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1.8.2 Warnings and Information Symbols

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Catalog Number

Serial Number

Manufacturer

Date of Manufacture

Consult Instructions for Use

Refer to Instruction Manual/Booklet (for critical safety instruction)

Caution

DEHP Symbol

Authorized Representative in the European Community

CE Mark of Conformity 2797

Prescription Only: Federal Law restricts this device to sale by or on the order of a physician

No User Service Recommended. Refer servicing to qualified ConMed Linvatec service personnel

Non Sterile

Sterile

Sterile - Sterilized Using EO

Sterile - Sterilized Using Irradiation

Do Not Steam Sterilize

Do Not Sterilize

Do Not Resterilize

Do Not Reuse (for Single Use Only)

Do Not Use Oil

Do Not Use for Plunge Cutting

10

Eye Protection Required

Do Not Immerse

~

Biohazard Risk

QTY

Quantity

Type B Applied Part

Type BF Applied Part

UL Classification Mark

UL Recognized Components

Rating Fuse

Fuse Location

Alternating Current

Protective Earth Ground

Equipotentiality (Equipment Potential)

Non-Ionizing Electromagnetic Radiation (RF Symbol)

Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Use by Date

Fragile

This Side Up

Do Not Use if Package is Damaged

Keep Dry

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Warning: Corrosive Substance

Warning: Electrical Hazard/High Voltage

Waste Electrical and Electronic Equipment (WEEE) Symbol. Regarding European Union end-of-life of product, indicating separate collection for electrical and electronic equipment Recycle. Batteries contain materials which must be recycled or disposed of properly. The disposal of batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1-866-426-6633, or outside the U.S. contact your local ConMed Linvatec representative for additional information on battery disposal or recycling.

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2.0 SYSTEM INSTALLATION AND OPERATION 2.1 Product Description 2.1.1 Handpiece Description

1

3 4

2

5

6

1.  Guard Collet - Accepts bur guards and neuro guards for various burs. 2.  Bur Lock Collar - Twist the bur lock collar counterclockwise (looking from the back of the handpiece) to open the collet to insert a bur. Twist clockwise to lock the bur in place. 3.  Swivel Sleeve - Twist to change the angle of the main handpiece body and the bur from 0° to 20°. 4.  Angle Locking Button - Locks the swivel sleeve in position. Slide the button to unlock the swivel sleeve and rotate it to the 0° or 20° position. Once completely in position the locking button will snap into place and lock the swivel sleeve in the desired angle. 5.  Tubing Set Cassette Holder - Accepts the handpiece cassette of the tubing set. 6.  Integrated Handpiece Cord - Attaches the handpiece to the controller.

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2.1.2 Tubing Sets Description

1

2

4 3

E9414 Tubing Set

6

5

Tubing sets contain the phthalate plasticizer DEHP, which may leach into the patient during administration of irrigant. Animal studies have shown that high-level exposure to DEHP may affect male fertility and reproductive development; these findings have not been confirmed in clinical studies. In determining use of this device in a child, or a pregnant or nursing female, the clinical benefits should outweigh any potential risk to the infant. Tubing sets are latex free.

LATEX

Tubing sets are one-time use only. Properly dispose of tubing sets after use. The ability to effectively clean and re-sterilize this single use device has not been established and subsequent re-use many adversely affect the performance, safety and/or sterility of the device.

2

STERILIZE

2.1.2.1 Tubing Set without Bur Irrigation (E9414) The E9414 Tubing Set is used in conjunction with the CoolFlex Drill only to provide cooling for the handpiece body. Cooling for the handpiece body is recommended at all times and is obtained from a supply of sterile fluid (water or saline) that is pumped to the body of the handpiece. 1.

Spike Line - Connects to the fluid supply for fluid distribution to the surgical site.

2.

Priming Chamber - Used to prime the tubing line.

3.

Cassette - Attaches to the peristaltic pump of the controller to aid in fluid delivery. 14

4.

Handpiece Cassette - Connects to the handpiece body to supply fluid for handpiece cooling. Also redirects fluid for recirculation back to the fluid supply.

5.

Recirculating Line - Routes the fluid back to the supply bag for recirculation.

6.

Handpiece Cord Clips - Used to attach the tubing to the handpiece cord.

2.1.2.2 Tubing Set with Bur Irrigation (E9415A)

1

3

2

E9415A Tubing Set

8

4

7

5

6

The E9415A Tubing Set is used in conjunction with the CoolFlex High Speed Drill. It has an affixed irrigation tip that attaches to any of the bur guards used with the CoolFlex Drill. Its purpose is to provide cooling for the handpiece body and irrigation for the surgical site. Cooling for the handpiece body is recommended at all times and is pumped from a supply of sterile fluid (water or saline) to the handpiece body. A common fluid supply is used for cooling and lavage. However, separate fluid lines are incorporated in the tubing set to avoid mixing the cooling fluid with the lavage fluid. 1.

Spike Line - Connects to the fluid supply for fluid distribution to the surgical site.

2.

Cassette - Attaches to the peristaltic pump of the controller for fluid delivery.

3.

Discharge Line - Routes the handpiece cooling fluid to the discharge bucket.

4.

Circulation Line - Routes the fluid to the handpiece cassette where it is used for cooling the handpiece. 15

5.

Handpiece Cassette - Connects to the handpiece body to supply fluid for handpiece cooling. Also redirects fluid to the discharge line.

6.

Irrigation Line and Tip - Routes fluid through an affixed irrigation tip for irrigation of the surgical site.

7.

Handpiece Cord Clips - Used to attach the tubing to the handpiece cord.

8.

Roller Clamp - Used to adjust the fluid flow to the surgical site.

2.2 Assembly/Installation Instructions 2.2.1 Bur Guard Installation 1.

To attach the bur guard: a. Align the etch mark on the guard with the etch mark on the handpiece guard collet.

b. Looking at the nose of the handpiece, hold the swivel sleeve and push the guard completely inward. Twist clockwise and release. The guard is now locked into place. 2.

Select the proper bur for the guard being used.

3.

To install the bur: a. Rotate the keyless chuck counterclockwise until the collet screws are aligned with the “unlock” icon.

16

b. Completely insert the bur. The safety line on the bur shank, if marked, must be hidden by the guard. WARNING: Ensure the safe-line mark on the bur, where indicated, is not showing. Damage or injury may result.

c. Rotate the keyless chuck clock-wise until the collet screws are aligned with the “lock” icon. d. Pull on the bur to ensure it is locked in place. 4.

To remove the bur: a. Rotate the keyless chuck counterclockwise until the collet screws are aligned with the “unlock” icon. b. Pull the bur out of the collet.

5.

To remove the guard: a. Push the guard inward. Twist the guard counterclockwise and remove.

2.2.2 Neuro Guard Installation When using a neuro guard and bur, the bur is inserted before the guard. 1.

To install the bur: a. Select the proper bur for the guard being used. b. Rotate the keyless chuck counterclockwise until the collet screws are aligned with the “unlock” icon.

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c. Completely insert the bur.

d. Rotate the keyless chuck clock-wise until the collet screws are aligned with the “lock” icon. e. Pull on the bur to ensure it is locked in place. 2.

To attach a neuro guard: a. Select the appropriate guard for the bur being used. b. Align the etch mark on the guard with the etch mark on the handpiece guard collet.

c. Looking at the nose of the handpiece, hold the swivel sleeve and push the guard completely inward. Twist clockwise and release. The guard is now locked into place. 3.

To remove the bur and guard, the guard must be removed first: a. Remove the guard by pushing the guard inward, twisting the guard counterclockwise and removing it. b. Remove the bur by rotating the keyless chuck counterclockwise until the collet screws are aligned with the “unlock” icon. Remove the bur.

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2.2.3 Tubing Set Installation 1.

If irrigation is being used, attach the black cassette of the tubing set to the console (reference console manual for proper cassette installation).

2.

Spike the fluid bag.

3.

Prior to connecting the clear plastic handpiece cassette of the tubing set to the handpiece, lubricate the O-Rings with sterile fluid.

4.

While holding the nose of the handpiece upward, place the plastic handpiece cassette onto the post within the cassette holder opening, perpendicular to the handpiece.

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5.

Twist the cassette clockwise until it is aligned with the handpiece body. No downward pressure is needed while turning.

6.

If leakage occurs at this interface while operating the handpiece, perform the following to alleviate the leakage: a. Remove the clear plastic cassette from the handpiece by reversing steps 4 and 5. b. Inspect the O-Rings to ensure they are seated properly within the handpiece cassette.

c. If no problems exist, reinstall the clear plastic cassette in the handpiece by following steps 4 and 5. d. If leakage still occurs, replace the tubing set. E9414 Tubing Set with Recirculation only: PRECAUTION: When using the E9414 Tubing Set, the tubing line MUST be fully primed (no air in line) or the handpiece will overheat, which will cause damage to the handpiece. 20

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1.

Prime the tubing by doing the following: a. Squeeze the priming chamber.

b. While continuously squeezing the priming chamber, operate the drill at low speed until fluid completely fills the tubing and is recirculated back into the fluid bag. Ensure fluid remains in the priming chamber during use with no air in the tubing.

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