Discus NV Microlaser Manual de usuario

NV Microlaser &

NV Ortho User’s Manual

This manual must be read thoroughly and understood prior to using

the laser system. CAUTION: Using the controls and adjustments or

performing laser procedures, other than as specied herein, may

result in hazardous radiation exposure.

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

Intended Uses ........................................................................................................................................... 3

Product Description ....................................................................................................3

Laser and Charging Unit ....................................................................................................................... 4

The NV Microlaser™/NVOrtho™ .......................................................................................................... 5

Laser Power Controller .......................................................................................................................... 5

The delivery tips ....................................................................................................................................... 5

The foot-switch......................................................................................................................................... 5

Delivery System Specications ........................................................................................................... 5

Specications ...............................................................................................................5

Contents of the Laser Container ...............................................................................6

Unpacking the Container ..................................................................................................................... 6

Setting Up Your NV Microlaser™ ...............................................................................7

Laser Display Unit .................................................................................................................................... 7

Attaching the Lithium Ion Battery ..................................................................................................... 7

Disposable Laser Tips ............................................................................................................................. 8

Charging Unit ............................................................................................................................................ 8

Wireless Foot Pedal ................................................................................................................................. 9

Menu Options ..............................................................................................................10

Selecting the Laser Mode ..................................................................................................................... 11

Selecting Pre-Set Procedures .............................................................................................................. 11

Selecting the Beeping Volume ........................................................................................................... 12

Procedures Guide ........................................................................................................13

Hard Tissue Procedures ......................................................................................................................... 14

Using the NV Microlaser™/NVOrtho™ ......................................................................14

Continuous Wave and Pulse Modes.................................................................................................. 14

Continuous Wave mode ........................................................................................................................ 14

Pulse Mode ................................................................................................................................................ 14

Operating the Laser ................................................................................................................................ 15

Foot pedal Assembly .............................................................................................................................. 15

Table of Contents

Base charger Assembly .......................................................................................................................... 15

NV Microlaser™/NVOrtho™ Assembly .............................................................................................. 15

Wearing Protective Eyewear ................................................................................................................ 15

Selecting the desired power ............................................................................................................... 15

Selecting a Laser Mode ......................................................................................................................... 16

Selecting a Pre-Set Procedure............................................................................................................. 16

Adjusting the Beeping Volume ......................................................................................................... 16

Test the laser before proceeding ....................................................................................................... 16

Perform the procedure .......................................................................................................................... 16

Discard the Tip .......................................................................................................................................... 16

Place the NV Microlaser™/NVOrtho™ Base Charger .................................................................... 16

Safety Considerations .................................................................................................16

Treatment Area ......................................................................................................................................... 16

Safety Eyewear ......................................................................................................................................... 17

Safety Signage .......................................................................................................................................... 17

Disposing of Fiber Tips .......................................................................................................................... 17

Labels, Signs, Warnings, and Safety Features ........................................................17

Labels and Signs ...................................................................................................................................... 17

Device Precautions ................................................................................................................................. 18

Warning Labels and Symbols ....................................................................................19

Safety Features ......................................................................................................................................... 20

Manufacturer’s Information ......................................................................................21

Calibration .................................................................................................................................................. 21

Sterilization ................................................................................................................................................ 21

Warranty Policy ........................................................................................................................................ 22

Repairs and Returns to Discus Dental, LLC ..................................................................................... 22

INTRODUCTION

The NV Microlaser is a dental diode laser that can be used for many dierent

soft tissue procedures. Laser technology has enabled dentistry to provide less

invasive treatment for many dental procedures, both preventative and restorative.

The Discus Dental® NV Microlaser™/NV Ortho™represents a new phase in dental

laser technology. With its streamlined design, you can perform a range of soft-

tissue procedures with ease, without worrying about ber management and

dealing with power cords. We designed the NV Microlaser™/NV Ortho™ to be a

compact wire-free laser that makes your day-to-day operations more ecient

and productive. For a list of approved procedures, please refer to page 13. All the

controls you need are accessible on the handheld unit which is lightweight and

extremely mobile.

Choosing to integrate laser science into your practice yields many benets,

including increased patient comfort, satisfaction and more ecient dental

care. To get the maximum benets of laser technology, consider joining a study

group so that you can exchange tips and ideas with fellow professionals. It’s

also an excellent way to keep abreast of the latest procedures and technological

advantages. A great place to start is the Academy of Lasers Dentistry, www.

laserdentistry.org.

The Discus website, www.discusdental.com, also provides information on new

products, accessories, and educational assistance for you and your professional

sta. If you have any questions regarding the use of the NV Microlaser™/NV

Ortho™, please call our toll-free support line. We’re here to help.

Intended Uses

The NV Microlaser™/NV Ortho™ is intended to be used for oral soft tissue

surgery, including: sulcular debridement of diseased brous tissue, i.e., excision

and biopsy; gingivectomy; gingivoplasty; lesion (tumor) removal; broma

removal; tissue retraction (troughing); apththous ulcers; gingival hyperplasia

(excision and recontour); crown lengthening; operculectomy; frenectomy; and

photocoagulation. In addition, the NV Microlaser™ /NV Ortho™ may be used for

periodontal procedures, including: laser soft tissue curettage; laser removal of

diseased, infected, inamed, or necrosed soft tissue within the periodontal pocket;

removal of highly inamed edematous tissue aected by bacteria penetration of

the pocket lining; and junctional epithelium.

PRODUCT DESCRIPTION

The progress achieved in recent years in ber optics and diode lasers technology

has made it possible to have commercial devices with multi-watt output power in

the near-infrared spectrum.

Welcome to the NV Microlaser™!

This laser technology is now being used in many areas of medicine and dentistry,

particularly oral surgery, arthroscopy, gastroenterology, general surgery,

dermatology and plastic surgery. The intended uses of these laser devices include

hemostasis, incision, excision, ablation, vaporization, and coagulation of tissue.

In dentistry, usage of laser devices ranges from cosmetic surgery to treating

periodontal disease.

As the dental laser industry grows, there is an increased demand for portable soft

tissue lasers. In today’s market, customers want a more portable laser solution to

avoid oce clutter and to reduce setup time. It has also become apparent that

a relatively low-power laser (2.0 maximum watts and 808 nm) covers virtually all

laser surgical requirements. The NV Microlaser™/ NV Ortho™ is the rst soft-tissue

laser developed as a handheld unit. It is wireless, lightweight, easy to set up,

simple to use, requires less power, and is cost ecient.

With NV Microlaser™/NV Ortho™, Discus Dental® introduces a proprietary

adjusting module for coupling a diode laser with a disposable ber. Fiber accuracy

is better than 5mm and the alignment is extremely stable. A module with a

specic lens was developed in order to achieve such precision and alignment. This

design greatly simplies the ber management and setup of operatory time as

the ber is attached into the tip allowing this item to be disposable and simple to

use. No ber scoring is needed as the disposable tip is provided already scored to

decrease setup time and user’s error.

Laser and Charging Unit

The Laser and Charging Unit comprise the following major modules:

The laser diode assembly contains one single-emitter laser diode of 2.0 watt

output power (Class IV laser) lasing at 808 nm. The diode laser is directly coupled

to a lens and aligned to the ber optic inside the removable tips, using a 2 axis

alignment system (patent pending).

Charging Unit

NV Microlaser™

The NV Microlaser™/NV Ortho™ is designed to dissipate heat during normal

operation. The laser module is mounted towards the tip of the unit, which acts as a

heat sink during normal operation. The temperature is monitored by a sensor that

prevents overheating.

The laser power controller provides electric power to the diode in continuous

wave and pulsed mode. It supplies about 2 VDC and current up to 4A to the

diodes. The controller contains a high eciency DC to DC converter that converts

the battery voltage to the precise voltage needed for laser operation. This ensures

that the majority of the energy is used for light and not converted into heat.

The delivery tips with ber built in consist of 400 micron core multi-mode,

optical ber, and a precise alignment mechanism. The ber is factory installed into

the tip and requires no installation by the end user.

The foot-switch is a (UL-approved) commercial foot-switch that provides

hands-free ON/OFF capabilities. This switch controls initiation/termination

of laser power wirelessly using 2.4GHz frequency. (Note: some models come with

a shrouded foot pedal)

Delivery System Specications

The delivery system is composed of a disposable, one time use plastic tip with

an optical quartz ber built in. The optical ber diameter is 400µm attached to a

custom made steel connector that precisely attaches via a magnet onto the laser

aperture component. The magnet acts as a guide with a precise tolerance for a

unique t of the disposable tip on to the laser unit.

SPECIFICATIONS

Dimensions of Charging Unit: ........2.7” H x 2.9” W x 8.0” L

Dimensions of Laser: ..........................6.9” L x 0.65” diameter

Weight: ...................................................1.9 ounces

Laser classication: .............................Class 4 laser device

Delivery system: ..................................Optical Fiber

Wavelength: ..........................................Laser 808nm ± 5nm

Maximum power: ................................2 Watts ± 20%

Beam divergence: ...............................617 mrad

Power range: .........................................0.1 Watt to 2.0 Watts

Pulse frequency: ..................................Fixed 10 Hz

Pulse duration: .....................................Fixed 0.05 seconds

Duty cycle: ............................................ Pulsed mode 50%

Continuous wave 100%

Audible notication: .........................Yes

Power requirements: .........................100-240 VAC @ 50 to 60 Hz

Current: ...................................................0.8 Amps

Battery: .................................................. Rechargeable lithium ion

20 minutes continuing lasing time @ 1.2 Watts

8 hours stand-by time

Wireless foot pedal frequency: ......2.4 GHz

Foot Pedal Power source: .................AA Batteries (provided)

The NV Microlaser™/NV Ortho™ complies with the following:

• IEC 60601-1

• IEC 60825-1

• 21 CFR 1040.10 and 1040.11

• FCC parts 15 and 18 (47 CFR)

• IEC 60601-2-22

CONTENTS OF THE LASER CONTAINER

1 NV Microlaser™/NV Ortho™ Main Body

2 Lithium Ion Batteries

3 Pairs of Safety Glasses

1 Base Charger (cradle)

1 Set of Safety Keys (2 keys total)

1 Power Supply for the Charger

1 Wireless Foot Pedal

2 AA Batteries for the Foot Pedal

2 Boxes of 10 Disposable Tips

DVD

Warranty Certicate and Caution sign

1 User’s Manual

1 Basic User’s Guide

1 Pack of Carbon Film

Unpacking the Container

No special assistance is required to unpack and assemble the NV Microlaser™/ NV

Ortho™. However, if you have any questions or concerns, call the Discus Dental

Lasers toll-free support line at (888) 876-4546.

Packaging should be inspected on arrival for evidence of shipping damage.

Damaged packaging may indicate the presence of unsafe product and it should

not be used until carefully inspected. If the package or product is damaged, the

product should not be used and should be returned. Product must be handled,

stored and opened in such a way that it is protected from inadvertent damage or

contamination.

Note: The shipping container has been designed to safely transport the NV

Microlaser™/NV Ortho™. We recommend that you keep the container in case

you need to ship the laser back for service or repair.

SETTING UP YOUR NV MICROLASER™ OR NV ORTHO™

Assembling the NV Microlaser™/NV Ortho™ is a simple process. The handheld laser

consists of three pieces: the display and laser unit, the battery, and the disposable

tip. You control the laser with the wireless foot pedal. When you are not using the

laser, it rests in the cradle/battery charger.

Laser Display Unit

All operations and procedures are conveniently located on the laser OLED display

unit. The red Power button turns the laser on and o. The Menu button allows you

to easily cycle through the various options. The Up and Down Arrow keys increase

and decrease the power. You also use the arrow keys to scroll through the options

when you are using one of the menus.

Attaching the Lithium Ion Battery

The NV Microlaser™/NV Ortho™ comes with two rechargeable lithium ion

batteries, allowing you to always have a fully charged battery available. To attach

the battery to the main body, match the two pins (male) located on the main laser

body into the battery slot (female). Twist the battery clockwise until it rmly locks

into place. The battery should lock in place and stay rm without any play. The

battery provides up to 20 minutes of continuous operation at 1.2 watts of power

when fully charged.

When you rst unpack the laser, charge the battery for two hours or until the

indicator light on the charger becomes green. The battery must be fully charged

before initial use.

Selection UP Laser ON / Emergency O

Selection DOWN Menu / Selection / O

Replacement batteries are available for sale at www.discusdental.com.

NV Microlaser™ battery P/N: LR1010

NV Ortho™ battery P/N: LR1011

Disposable Laser Tips

Each ber tip is protectively wrapped in its own package. The ber tips are pre-

scored and pre-stripped. Before attaching the tip, submerge it in a solution of

Cavicide® (or equivalent product) for 3 mins. The tip must only be used for a single

procedure and then properly disposed.

The tip slips easily onto the laser shaft, aligning on the ridges. The unit contains

a strong magnet, which snaps the tip into place and aligns the tip with the laser

aperture. When the tip is connected, there is visual verication indicating that the

tip is properly attached and the laser unit is on standby waiting to be used.

You can attach the disposable tip in six dierent positions, allowing the user to

reach dicult areas during surgical soft-tissue procedures.

NOTE: The disposable plastic hand piece tips are supplied non-sterile by the

manufacturer and must be discarded in an infectious waste container (SHARPS)

after each use. There is no re-use or re-sterilization procedure indicated.

NOTE: Steeply bending or improperly securing the ber tip may lead to damage

to the laser delivery system and/or harm the patient or user.

Charging Unit

The charging unit securely stores the laser unit and charges the batteries at the

same time. You can charge up to three batteries:

two in the dedicated battery ports and one in the resting slot for the laser.

NOTE: The laser comes with two batteries. You may order additional batteries

if desired.

Line-up pins with holes on battery

and twist clockwise to lock

Connect the provided power supply at the back of the charging unit. The power

supply can be used in outlets of 100~240 VAC.

To store or recharge the laser, you must rst remove the disposable tip. Place the

laser at in the slot by tipping it slightly up and inserting the end of the battery

rst and then lowering it into the slot. Do not place the laser upright in the vertical

battery charging ports.

Recharging a completely discharged battery takes approximately 1 hour. The LED

lights on the cradle indicate the amount of charge remaining. If the light is red,

the battery is low. A orange light indicates an almost full charge. When the light is

green, the battery is fully charged.

NOTE: If incorrect power supply is used the charger will not charge, and

permanent damage may occur to the charger.

Wireless Foot Pedal

The battery-powered wireless foot pedal is composed of a supporting plastic

base plus the pedal which comes attached to the base. In order to power the foot

pedal, you must insert the provided AA batteries that came with the laser. Before

inserting the batteries, make sure that the laser is completely turned o and that

the laser battery is not attached.

1. Turn the foot pedal upside down to locate the battery slot.

2. Remove the lid and insert the batteries.

3. Close the battery lid.

4. To turn the foot pedal to the ON position, insert the safety key and

turn it clockwise.*

Battery

Charger

DOCK 3

Battery

Charger

DOCK 2

Battery

Charger

DOCK 1

Charge indicator light Low

Battery Charging Fully

Charged

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