Biolase Epic V series User manual

EPIC V-Series User Manual P/N 5400430 Rev. A

Founded in 1986, BIOLASE, Inc. specializes in lasers for medicine

and dentistry that feature proprietary and patented technologies for

performing minimally invasive surgeries, reducing pain and improving

clinical results.

Only BIOLASE combines the leading laser technology – continuously

improved through ongoing clinical R&D and engineering – with

unmatched training, practice integration support and service.

About BIOLASE

BIOLASE, Inc.

4 Cromwell

Irvine, CA 92618 USA

949.361.1200

888.424.6527

biolase.com

MT Promedt Consulting GmbH

Altenhofstrasse 80

D-66386 St. Ingbert/Germany

+49 6894 581020

mt-procons.com

ComfortPulse, WaterLase, and WaterLase iPlus are either trademarks or registered trademarks of BIOLASE,

Incorporated in the United States and/or other countries. All other trademarks are property of their registered

owners. Subject to change without notice.

User Manual

EPIC V-Series User Manual P/N 5400430 Rev. A

Made in the USA

EPIC_V-Series_UserManual_5400430_RevA_Cover.indd 1 6/24/2013 9:20:03 AM

TABLE OF CONTENTS

TABLE OF CONTENTS............................................................................................................. 0

Introduction................................................................................................................................ 3

1.Packaging............................................................................................................................... 4

1.1 System Parts List.............................................................................................................. 4

1.2 Facility Requirements....................................................................................................... 4

2. Equipment Description........................................................................................................... 5

2.1 General ............................................................................................................................ 5

2.2 Base Console................................................................................................................... 5

2.3 Control Panel.................................................................................................................... 5

2.4 Surgical Delivery System.................................................................................................. 6

2.6 Fiber Optic Connection..................................................................................................... 6

2.7 Single-Use Tips................................................................................................................ 7

2.8 Surgical Handpiece Assembly.......................................................................................... 7

2.9 Deep Tissue Handpiece (Optional Accessory).................................................................10

3. Safety....................................................................................................................................11

3.1 Precautions .....................................................................................................................11

3.2 Safety Instructions...........................................................................................................11

3.3 Safety Features...............................................................................................................12

Energy Monitor ..................................................................................................................12

System Monitor..................................................................................................................12

Power Switch.....................................................................................................................13

Access Key Code...............................................................................................................13

Control Button....................................................................................................................13

Wireless Footswitch...........................................................................................................13

Remote Interlock................................................................................................................14

Emergency Stop ................................................................................................................14

Functional Display..............................................................................................................15

3.4 Safety Classification........................................................................................................15

4. Operation Instructions...........................................................................................................16

4.1 System setup...................................................................................................................16

4.2 Operation - Turn on the EPIC V-Series............................................................................17

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4.3 Settings Screen...............................................................................................................18

4.4 Pairing the Footswitch to the Laser console.....................................................................18

4.5 Control Button .................................................................................................................20

4.6 Entering READY or STANDBY Modes ............................................................................20

4.7 READY Mode..................................................................................................................20

4.8 Wireless Footswitch.........................................................................................................21

4.9 Peak Power Display ........................................................................................................21

4.10 Pulse Mode Selection....................................................................................................21

4.11 Using the EPIC V-Series Touch Screen Display............................................................23

4.12 Procedures Button.........................................................................................................24

4.13 Turn the Laser Console Off............................................................................................24

5. Specifications........................................................................................................................25

5.1 General ...........................................................................................................................25

5.2 Electrical..........................................................................................................................25

5.3 Laser...............................................................................................................................25

5.4 Other Light Sources.........................................................................................................26

6. Contraindications, Warnings & Precautions ..........................................................................27

6.1 Contraindications.............................................................................................................27

6.2 Warnings and Precautions...............................................................................................27

Prescription Statement.......................................................................................................27

Eyewear.............................................................................................................................27

Anesthesia.........................................................................................................................27

Adjacent Structures............................................................................................................27

Suction...............................................................................................................................28

Plume Removal..................................................................................................................28

Clinical Use........................................................................................................................28

Training..............................................................................................................................28

7. Clinical Applications..............................................................................................................29

7.1 Introduction......................................................................................................................29

7.2 Indications for Use...........................................................................................................29

7.3 Soft Tissue Surgery and Dental Use................................................................................29

Tip Initiation: Parameters and Method................................................................................29

Pre-programmed Settings for Dental Soft Tissue and Surgical Procedures........................31

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7.4 Table of EPIC V-Series Pre-Programmed Settings..........................................................32

7.5 Pain Therapy...................................................................................................................33

Recommended Use...........................................................................................................33

Pre-Progammed Settings for Pain Therapy........................................................................34

Pain Therapy - Warnings and Precautions.........................................................................34

Using the Deep Tissue Handpiece.....................................................................................35

8. Maintenance .........................................................................................................................36

8.1 Daily Maintenance...........................................................................................................36

8.2 Cleaning and Sterilization Procedures.............................................................................36

Cleaning and Disinfecting Instructions for the Surgical Handpiece, and the Reusable Fiber

Optic Cable........................................................................................................................36

To Clean the Surgical Handpiece:......................................................................................37

Steam Sterilization for Surgical Handpiece, Single Use Tips, Tip Initiation Block...............37

Cleaning the Deep Tissue Handpiece................................................................................37

8.3 Installing/Replacing the Console Battery Pack.................................................................38

8.4 Changing the Wireless Footswitch Batteries....................................................................38

8.5 Transportation.................................................................................................................39

8.6 Storage............................................................................................................................39

9. Calibration.............................................................................................................................40

9.1 Calibration Schedule .......................................................................................................40

10. Software Specification.........................................................................................................40

11. Troubleshooting ..................................................................................................................40

APPENDIX A – Definition of Symbols on Labeling....................................................................42

APPENDIX B – Safety Precautions for Lithium-Ion Battery Packs.............................................46

When USING the Battery.......................................................................................................46

WHEN CHARGING the Battery.............................................................................................47

When DISCHARGING the Battery.........................................................................................48

Appendix C - Spare Parts & Accessories..................................................................................49

System Accessories..............................................................................................................49

Single Use Tips.....................................................................................................................49

Appendix D - Wireless Equipment Compliance Statement........................................................51

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INTRODUCTION

The EPIC™ V-Series diode laser is a surgical and therapeutic device at the cutting edge of

technology, designed for a wide variety of dental and surgical soft tissue procedures, as well as

for use in providing temporary relief of minor pain in domestic animals (i.e., dogs, cats, birds,

and horses).

The EPIC™ V-Series utilizes a solid state diode as a semiconductor source for invisible infrared

radiation. The energy is delivered to the treatment site via flexible fiber connected at one end to

the laser source and the other end to the Handpiece. Various types of single use, disposable

tips are designed and optimized for different applications. The device is activated by means of

a wireless footswitch.

The EPIC V-Series is restricted to sale by or on the order of a licensed veterinarian and its use

requires proper clinical and technical training. This manual provides instructions for those

professionals who have completed the appropriate training.

When used and maintained properly, the EPIC V-Series will prove a valuable addition to your

practice. Please contact BIOLASE Customer Service at 1-800-321-6717 in the USA and

Canada for any service needs. If you are located outside the U.S., please contact your

BIOLASE-authorized distributor for any service needs.

CANADA: This device must be installed and operated according the guidelines of CAN/CSA-

Z386-92 “Laser safety in a health care facility.”

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1.PACKAGING

1.1 SYSTEM PARTS LIST

The EPIC V-Series laser system includes the following:

1. Laser Console (lithium ion battery pack already installed)

2. Screen Protectors box (Peel-off clear screen cover - qty. 30)

3. Delivery System box

4. Tips box

5. Surgical Handpiece box (contains two (2) Surgical Handpieces)

6. Three (3) pairs of protective laser eyewear)

7. DC power supply and power cord (one (1) US and one (1) International)

8. User Manual (Hard Copy only)

9. Welcome Kit (Welcome Letter, BIOLASE store information, Quick Setup Guide,

Guide to Online Training & Product Registration Card, Tip User Guide, Limited

Warranty Information)

10. Laser Warning Sign

11. Tip Initiation Kit

12. Remote Interlock cable

13. Philips-head screwdriver (for installing Footswitch batteries)

14. Footswitch

15. AAA batteries (2)

NOTE:

The laser ships with the lithium ion battery pack already installed.

NOTE:

Use proper care when transporting the unit. Refer to Section 8 in this User

Manual for instructions.

WARNING:

No modification of this equipment is allowed.

1.2 FACILITY REQUIREMENTS

Electrical Supply (100-240V ~):

1.5A, 50/60Hz

Environmental Requirements:

Temperature: 20-25 ºC

Humidity: 15-95%, Non-condensing

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2. EQUIPMENT DESCRIPTION

2.1 GENERAL

The EPIC V-Series system consists of three components:

● Base Console

● Delivery System

● Wireless Footswitch

2.2 BASE CONSOLE

The Console has a Display Panel (Touch Screen and Control Button) in front. It can be powered

by an external mains power supply or an internal replaceable lithium ion battery pack, 14.4V,

2.9 Ah.

2.3 CONTROL PANEL

ITEM ITEM DESCRIPTION

CONTROL

Button

Turns the controls and display on and

off; places the unit into STANDBY or

READY or SLEEP mode

LED

Indicator

•Amber indicates unit is in

STANDBY mode.

•Green indicates unit is in READY

mode.

•Blinking green indicates the

emission of laser power.

•Blinking blue indicates pairing

between the footswitch and laser

console is active

Figure 2.1: Control Panel (Front View)

LED Indicator

Control Button

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2.4 SURGICAL DELIVERY SYSTEM

NOTE:

All fiber optic cables, Handpieces & tips are shipped non-sterile.

The EPIC V-Series Re-Useable Delivery System with surgical Handpiece consists of:

•Re-useable Fiber Optic Assembly

•Re-useable Surgical Handpiece (Figures 2.4, 2.5)

•Disposable Tips (See Figures 2.7, 2.8, 2.9, 2.10)

NOTE:

The fiber optic cable is detachable from the console. The Handpiece is a Re-usable

accessory and will require cleaning and sterilization prior to each patient treatment.

Tips are intended for single-use only and must be disposed of after each patient use.

Proper tip disposal in a biohazard medical waste Sharps container is required. Tips

must be steam sterilized prior to use. For instructions on cleaning and sterilization of

the Handpiece and tips Refer to Section 8.

2.6 FIBER OPTIC CONNECTION

Only install the fiber optic cable while the laser console is turned off. The fiber optic cable is

attached to the console by inserting the optical access plug (Figure 2.2) into the optical access

port (Figure 2.3).

CAUTION:

Do not connect or disconnect the fiber while the laser console is turned

on. Only connect or disconnect the fiber when the laser console is turned

off.

For storage, wind the cable in the fiber storage channel around the base of the console in a

counterclockwise direction (Figure 2.7).

CAUTION: Do not bend the fiber optic at a sharp angle, as it is can break. Make

sure it is not caught or pinched between the housing and the fiber optic

access plug.

To disconnect the fiber optic cable from the laser console, make sure the cable is completely

unwound from the console base, grab the fiber optic access plug and slowly pull it straight

back from the optical access port.

NOTE:

Make sure you hear the fiber optic “click” into place; if you do not hear it “click,”

remove the fiber optic and reinstall it.

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Figure 2.2: Fiber Optic Access Plug

Figure 2.3: Optical Access Port

2.7 SINGLE-USE TIPS

The tips are single-use accessories and are provided in three core diameters: 200μm, 300μm,

and 400μm, in different lengths (see Appendix C).

CAUTION:

Tips are single-use only to avoid cross-contamination and are designed

to withstand a single sterilization cycle; they must be disposed of after

use in a biohazard medical waste Sharps container.

To connect the tip, insert it firmly into the distal end of the Handpiece as far as it will go, then

tighten by turning clockwise (Figure 2.7). Bend the metal cannula according to the specific

procedure requirements (Figure 2.10).

NOTE:

To provide proper laser operation, do not connect tips when the Handpiece is

disconnected.

2.8 SURGICAL HANDPIECE ASSEMBLY

►To connect the Handpiece to the fiber optic assembly, push the Handpiece on the fiber

shaft until it clicks on and is secured at connected position.

►To disconnect the Handpiece from fiber optic assembly:

•Take the Handpiece body in one hand and the shaft in another

•Push the two buttons on the Fiber Shaft

•Pull the Handpiece with the ring to separate.

► Remove the fiber tip by twisting the tip counterclockwise.

EPIC™ V Series User Manual

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5400430 Rev A

Fiber Shaft Protective Cap

Handpiece

Figure 2.4: Connecting the Handpiece to the fiber optic assembly

Figure 2.5: Surgical Handpiece Assembly fully assembled

Figure 2.6: Disconnect the Handpiece from the fiber optic assembly by pressing both buttons at the

base of the Fiber Shaft

Tip Assembly

Figure 2.7: Insert the fiber tip into the Handpiece and twist clockwise until snug

Figure 2.8: Remove the fiber Tip by twisting the tip counterclockwise

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