Hall MicroPower+ and Oral-Max Elite Instruction Manual

Proprietary Information This manual contains information deemed proprietary to CONMED Corporation. The information contained herein, including all of the designs and related materials, is the sole property of CONMED and/or its licensors. CONMED and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of CONMED. CONMED reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law.

Linvatec, Hall, Advantage, PowerPro, E9000, Surgairtome Two, Micro 100, Ultrapower, MicroPower+, OralMax Elite and SmartGuard are trademarks or registered trademarks of CONMED Corporation.

 CONMED Corporation 2020. All Rights Reserved.

Record the Model and Serial Numbers of the handpieces, and date received. Retain for future reference. Handpiece Model No.

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Handpiece Model No.

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Handpiece Model No.

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Table of Contents

1.0

INTRODUCTION 1.1 1.2 1.3 1.4 1.5

Operating Principle... 1 Indications for Use... 1 Intended Use... 1 Contraindications... 1 Warnings and Precautions... 2 1.5.1 Warnings... 2 1.5.2

1.6 1.7 1.8

Precautions... 4

Environmental Directives... 5 Product Photographs and Drawings... 5 Symbol Definitions... 6 1.8.1 Product Symbols... 6 1.8.2

2.0

Page

Warnings and Information Symbols... 6

SYSTEM INSTALLATION AND OPERATION 2.1

Product Description... 8 2.1.1 Handpiece Descriptions... 8 2.1.2

2.2

2.3

Irrigation Tubing Set (E9418) for use with the MicroPower+ and OralMax Elite High Speed Drills... 9

Assembly/Installation Instructions... 10 2.2.1 Handpiece Cord Installation... 10 2.2.2

Hall Bur Guard Assembly Instructions... 11

2.2.3

Reciprocating Saw Blade Installation and Removal... 17

2.2.4

Sagittal Saw Blade Installation and Removal... 18

2.2.5

Oscillating Saw Blade Installation and Removal... 19

2.2.6

Detachable Handpiece Activation Lever Installation and Removal... 20

2.2.7

Tubing Set (E9418) Installation... 20

Operating Instructions... 21 2.3.1 Drill Operation... 21 2.3.2

Reciprocating Saw Operation... 22

2.3.3

Sagittal Saw Operation... 22

2.3.4

Oscillating Saw Operation... 23

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Table of Contents

Page

2.3.5

Footswitch Operation... 24

2.3.6

Handpiece Cord Button Operation... 26

2.4

3.0

Preoperative Functional Test... 27 2.4.1 Bur Guard Functional Test... 27 2.4.2

Medium Bur Guard (1375-012/1375-012P) Functional Test... 27

2.4.3

Handpiece Functional Test... 28

MAINTENANCE 3.1

3.2

Cleaning Information... 29 3.1.1 Warnings, Precautions and Notes... 29 3.1.2

Manual Cleaning Instructions... 29

3.1.3

Inspection Recommendations... 30

3.1.4

Attachment Lubricating Instructions... 30

Sterilization Information... 31 3.2.1 Warnings, Precautions and Notes... 31 3.2.2

3.3 3.4

4.0

Troubleshooting... 33 Maintenance Schedule... 34

TECHNICAL SPECIFICATIONS 4.1

Product Technical Specifications... 35 4.1.1 Handpieces... 35 4.1.2

4.2

4.3

Handpiece Cord (MC5057)... 38

Product Environmental Requirements... 39 4.2.1 Environmental Technical Specifications... 39 4.2.2

5.0

Sterilization Instructions... 32

Electromagnetic Requirements... 39

Handpieces, Attachments and Accessories... 40

CUSTOMER SERVICE 5.1

Assistance and Repair... 42

ii

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 MicroPower+ and OralMax Elite Handpieces are electrically powered by the surgical console to provide rotary force to the accessory (burs, drill bits or attachment) for bone cutting, shaping, drilling and soft tissue resection with the Medium Speed Drill, or bone cutting, shaping, or resection with the saws. The MicroPower+ and OralMax Elite Handpieces are controlled by an activation lever on the handpiece or a footswitch. A control button on the handpiece-to-console cord allows modifying the speed range while in the sterile field. An irrigation tubing set may be connected to the drill handpiece as a source of irrigation for the blade, bit and bur accessories during operation. Consult the associated CONMED surgical console instruction manual prior to operating this equipment.

1.2 Indications for Use The MicroPower+ High Speed Drills (PRO7000SE) and their accessories perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, and plastic/reconstructive procedures. The OralMax Elite High Speed Drills (PRO7000DE), and their accessories perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial. The MicroPower+ Medium Speed Drills (PRO7100SE), Saws (PRO7200SE, PRO7300SE, PRO7400SE) and their accessories perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, plastic/reconstructive and oral/maxillofacial procedures.

1.3 Intended Use Same as Indications for Use above.

1.4 Contraindications None 1

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. 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

!

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 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. 2

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. 18. When using the MicroPower+ Sagittal Saw (PRO7200SE), placing excessive bending or twisting force on the sagittal saw blade may cause the collet to open and release the saw blade. Do not use saw blades to pry, remove bone grafts, or as a leverage point. Patient or user injury could occur. 19. Bur guards should always be checked before use. To reduce the risk of injury, prior to surgery, spin the bur guard on a bur. If the bur guard spins freely, the bearing is still good. Otherwise, the bur guard must be sent for repair immediately. DO NOT USE. Overheating can occur if bur guard bearings are worn or not kept clean. 20. Do not operate the drills without the appropriate bur guard and the collet locked. Always use a bur of the proper length. The tip of the bur guard should cover the safe line on the bur, if applicable. Without the stabilization that the proper guard provides, the bur can break and be propelled with great force. 21. Handpieces are provided by CONMED configured with levers either permanently attached or detachable. When configured as a detachable lever, always remove it when operating the handpiece with a footswitch. Accidental activation could occur, possibly injuring the patient or user. 22. To avoid unintentional handpiece activation, unplug the footswitch when using a levered handpiece. When the footswitch is attached to the controller it will remain active.

3

1.5.2 Precautions

!

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 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. 14. Do not operate the oscillating saw or reciprocating saw without a blade locked securely in place. Damage to the handpiece may occur. 15. Never lock the drill collet without a bur inserted. Damage to the collet may result.

4

16. Different saw blade designs and blade features can produce varying cutting efficiencies. For example: shorter fine-toothed blades will cut hard bone more efficiently than shorter coarse-toothed blades.

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 Electric 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.

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.

5

1.8 Symbol Definitions 1.8.1 Product Symbols SAFE

Safe Mode

RUN

Run Mode

LOCK

Collet Lock Position Indicates Handpiece should not be Immersed in any fluid.

1.8.2 Warnings and Information Symbols Catalog Number

REF

! EC REP

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

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 service personnel

Non Sterile STERILE

2

STERILIZE

EO

Serial Number

SN

Sterile - Sterilized Using EO

STERILE STERILE

R

Sterile 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

6

Eye Protection Required

Biohazard Risk

Do Not Immerse

~

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

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 1-800-237-0169, or outside the U.S. contact your local CONMED representative for additional information on battery disposal or recycling. 7

2.0

SYSTEM INSTALLATION AND OPERATION

2.1 Product Description

2.1.1 Handpiece Descriptions

7 1.

Bur Lock Collar - Rotate to lock or unlock a bur.

2.

Blade Collet - Holds the blade in place.

3.

Blade Lock Collar - Rotate to open or lock the blade collet.

4.

Collet Lock Mechanism - Locks a blade into place.

5.

Activation Lever - Depress to operate the handpiece. The activation lever can be removed for leverless operation on the handpiece (Refer to section “2.2.6 Detachable Handpiece Activation Lever Installation and Removal”).

6.

7.

8.

5

6

1

Medium Speed Drill (PRO7100SE) High Speed Drills (PRO7000SE, PRO7000DE)

4

5

6 7

Sagittal Saw (PRO7200SE)

6

7

Safe/Run Slide - Place in the “SAFE” position prior to inserting or removing attachments and/or accessories (blades, bits, burs) and when the handpiece is not in use. Place in the “RUN” position to activate the handpiece.

8 3

5

Reciprocating Saw (PRO7400SE)

6 7

Handpiece Cord Connector - The handpiece cord connects here to provide power to the handpiece. Uses the MC5057 Handpiece Cord.

5 3

2

Oscillating Saw (PRO7300SE)

Collet Indexing Lock - locks collet at 45° increments.

NOTE: Do not allow saline to enter into the handpiece cord connector and cord. Damage may occur to the handpiece.

8

6

2

1

3

E9418 Irrigation Tubing Set

4

5

2.1.2 Irrigation Tubing Set (E9418) for use with the MicroPower+ and OralMax Elite High Speed Drills The E9418 Tubing Set is used to provide irrigation for blades, bits and burs while using the MicroPower+ and OralMax Elite High Speed Drills. 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 to aid in fluid delivery.

3.

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

4.

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

5.

Irrigator Tip - Accepts various irrigation tips (Refer to section “4.3 Handpieces, Attachments and Accessories”) for the High Speed Drills for fluid distribution to the surgical site.

6.

Sensor Dot- Indicates correct positioning of cassette on pump. Controller pump will not run unless sensor dot is in place.

9

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 ferility 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 for Single use. The ability to effectively clean and resterilize this single use device has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of the device.

2

STERILIZE

2.2 Assembly/Installation Instructions 2.2.1 Handpiece Cord Installation To attach the handpiece cord: 1.

Ensure pins on cord and handpiece are completely dry prior to connecting.

2.

Insert the handpiece cord into the cord receptacle of the handpiece.

3.

Push together until fully seated.

NOTE: Do not force the cord into the handpiece cord connector. This may bend the pins and damage the handpiece.

4.

Connect the handpiece cord to the appropriate console.

To remove the handpiece cord: 1.

Press the latch.

2.

Remove the cord from the handpiece.

10

2.2.2 Hall Bur Guard Assembly Instructions

2.2.2.1 Guards These instructions apply to following Guards: • Medium Bur Guard (1375-012/1375-012P) • Long Bur Guard (1375-011/1375-011P) • Extra-Long Bur Guard (1375-023/1375-023P) • Tissue Retractor Guard (1387-022) NOTE: When using the Tissue Retractor Guard, use only 5092 series long burs which have a diameter of 4.0 mm or less. The recommended bur is the 5092-136 Long Oval Cutting Bur. To install a bur guard: 1.

Slide the appropriate bur guard over the end of the drill.

2.

Ensure it is seated completely.

Photo below shows the Tissue Retractor Guard.

Prior to installing a bur, but only while using the 1375-012/1375-012P Medium Bur Guard, it is recommended that a SmartGuard® Protector Sleeve (1375-112) be attached. Reference the associated insert that comes packaged with the SmartGuard for additional information.

11

NOTES: •

SmartGuard Protector Sleeves are designed to be attached to the Medium Bur Guard during surgical applications. They are intended to be used as a heat-sensing and insulating device that changes color from PURPLE (SAFE to use bur guard) to PINK (REPLACE bur guard) to indicate over-heating of the attached bur guard.

•

Overheating might occur if bearings are worn or are not kept clean. If overheating occurs while a SmartGuard Protector Sleeve is attached to the Medium Bur Guard, the SmartGuard Protector Sleeve will change color from PURPLE to PINK. Immediately discontinue use of the bur guard to prevent possible injury to the patient and/or operator. Replace the bur guard and return original bur guard for service.

•

Under prolonged use or intense cutting, the tip of the SmartGuard Protector Sleeve may turn pink while the rest of the sleeve retains its purple color. If more than 50% of the SmartGuard Protector Sleeve turns pink, discontinue use immediately to prevent possible injury to the patient and/or operator. Replace the bur guard and return original bur guard for service.

To attach a SmartGuard Protector Sleeve: 1.

Remove the SmartGuard Protector Sleeve from its sterile packaging within the sterile field.

2.

Press-fit the SmartGuard Protector Sleeve onto the end of the associated bur guard until fully seated (see figure below).

3.

After the SmartGuard Protector Sleeve is attached, install a bur.

To install a bur: 1.

Select a proper length bur for the guard.

2.

Ensure the bur lock is in the unlocked position.

12

3.

Insert the bur to the safe line or until the bur seats completely if no safe line is observed.

4.

Lock the bur in place by twisting the bur lock clockwise until the red indicator dots are aligned.

5.

Always pull on the bur to ensure bur is fully locked in position.

To remove the SmartGuard Protector Sleeve: 1.

Remove the bur.

2.

Grasp the tabs of the SmartGuard Protector Sleeve between the thumb and forefinger and pull.

3.

Discard the used SmartGuard Protector Sleeve properly.

13

2.2.2.2 Laminectomy Bur Guard (1375-020) NOTES: •

Use the 5092-203 Long Carbide Bur with the 1375-020 Laminectomy Bur Guard.

•

The Laminectomy bur is the only bur that can be inserted prior to placing the appropriate bur guard on the handpiece.

To install a bur: 1.

Ensure the bur lock is in the unlocked position.

2.

Insert the laminectomy bur into the handpiece until the bur seats completely.

3.

Lock the bur in place by twisting the bur lock clockwise until the red indicator dots are aligned.

4.

Always pull on the bur to ensure bur is fully locked in position.

To install a bur guard: 1.

Slide the appropriate bur guard over the bur and the end of the handpiece.

2.

Ensure it is seated completely.

3.

Do not operate the drill without the bur guard completely seated to the nose of the drill.

14

2.2.2.3 Angle Attachments These instructions apply to following Attachments: • 20° (1375-032) Angle Attachment • 20° (1375-033) Extra Long Angle Attachment NOTE: Use only long burs (5092 series) in the 1375-032, 20° Angle Attachment and extra long burs (5093 series) in the 1375-033, 20° Extra Long Angle Attachment. To install the attachment: 1.

Ensure the bur lock is in the unlocked position.

2.

Slide the attachment over the end of the drill. Ensure it is seated completely.

3.

Lock the attachment in place by twisting the bur lock clockwise until the red indicator dots are aligned.

4.

Always pull on the attachment to ensure attachment is fully locked in position.

5.

Open the attachment collet by twisting the attachment bur locking ring counter-clockwise until the ring is fully open.

6.

Insert the bur into the attachment until it is completely seated.

7.

Twist the attachment bur locking ring clockwise until the locking ring is in the locked position.

8.

Always pull on the bur to ensure bur is fully locked in position. 15

2.2.2.4 Contra-Angle Attachments These instructions apply to following Attachments: • 70° Contra-Angle Attachment with surgical head (1375-035) • 90° Angle Attachment (1375-036) NOTE: Use only short burs (5090 series) and extra short burs (5089 series) with attachment 1375-035. To install the attachment: 1.

Ensure the bur lock is in the unlocked position.

2.

Place the attachment over the end of the drill. Ensure the attachment is seated completely.

3.

Lock the attachment in place by twisting the bur lock clockwise until the red indicator dots are aligned.

4.

Always pull on the bur to ensure bur is fully locked in position.

To insert a bur: 1.

Place the bur in the opening of the attachment.

2.

Use the grooved side (the side without the pin) of the bur changer (1375-003) to press the bur firmly in place.

16