Biolase Ilase User Manual

User Manual

iLase™ User Manual P/N 5400230 Rev. H

™

Copyright ©2014

BIOLASE, Inc.
All Rights Reserved.

iLase

softwa re cop y right © 20 10

BIOLASE, Inc.

Biolase, the Biolase logo, iLase,

or

registered

trademarks of BIOLASE, Inc. Other

are either trademarks

trademarks are property of their

registered owners.

BIOLASE,

www.b

Inc.

iolase.com

USA

4 Crom

well

Irvine, CA 92618

Telephone: [phone]

Telephone: [phone]

Fax: (

949) 273-6687

Service:

[phone]

1

TABLE OF CONTENTS

19

6.2 Steam Sterilization of the
Handpiece Cover and Tips

6.3 Disposal- Tips, Batteries,
Device and Parts

7.2 iLase Cover Grip
Replacement

2.6 Personal Protective
Equipment

3.2 Cleaning and Sterilization
Before Use on Patients

8.2 Warning and Error
Messages

4.1 Personal Protective
Equipment

4.4 Initial Selection of a
Procedure

4.9 Selecting a Different
Procedure

1 Introduction

1.1 Description 2

1.2 Indications for Use 3

1.3 Contraindications 4

2 Precautions and Warnings 5

2.1 Clinical 5

2

5 Clinical 17

5.1 Presets 17

6 Cleaning and Sterilization

6.1 Cleaning and Disinfection 19
20
21

2.2 Laser Safety 6

2.3 Electrical Safety 6

7 Maintenance 22

2.4 Fire Safety 6 7.1 Regular Maintenance 22

2.5 Cleaning and Sterilization 6

22

7 7.3 System Configuration 23

3 Installation 8

8 Troubleshooting and Repairs 24

3.1 Unpacking 8 8.1 Troubleshooting 24
9

24

3.3 Battery Charging 9 8.3 Repairs 25

3.4 Battery Installation 10

3.5 Attaching a Tip 10

9 Laser Calibration 26

9.1 Laser Calibration 26

4 Operating Instructions 11

11

4.2 Preparation for Use 11

4.3 Starting the iLase 11

10 Specifications

11 Label s

27

28

12 11.1 Labels 28

4.5 System Modes 12 11.2 Location of Labels 28

4.6 Firing the Laser 13

4.7 Tip Initiation Instructions 14

4.8 Main Screen 14
15

4.10 Selecting a Pulse Mode 15

4.11 Adjusting Laser Power 16

5400230 Rev. H

2

1

Introduction

1.1 DESCRIPTION

The iLase™ dental soft tissue laser is a surgical device designed for a wide variet y of dent al soft

tissue procedures. The iLase uses a solid state laser diode as a source of invisible infrared radiation.
The energy is delivered to the treatment site via a single-use fiber optic tip assembly. Several types
of tips are available for use with the iLase to perform different procedures.

The iLase system consists of two elements:

►

The iLase Handpiece contains the laser diode, the replaceable fiber optic tip, removable cover
with integrated finger grip, a main body with control electronics, integrated sele ctor·switch, organic
LED (OLED) display, and rechargeable battery. The iLase Handpiece delivers laser energy, under
user control, to the treatment site.

►

The iLase Charging Station is used for charging and sto ring the
iLase and replacement batteries. The iLase and discharged
batteries are placed in receptacles in the charging station where
they are automatically recharged. Up to four batteries with or
without main bodies attached may be charged at one time.

The Charging Station contains four charging indicator lights located on the f ront panel of the charger.

There is one indicator for each of the battery receptacles at the top of the unit. When the indicator
displays an amber color, the battery is charging. A green light indicates that the Battery is fully
charged. The charging station is powered by a low voltage power suppl y t hat connects at the rear of
the unit.

iLase

Figure

handpiece

1·1:

and fiber optic tip'

5400230 Rev. H

3

1.2 INDICATIONS FOR USE

Dental Soft Tissue Indications: Incision, excision, vaporization, ablation and coagulation of oral soft

tissues including marginal and inter-dental gingival and epit helial l ining of free gingiva and the
following specific indications:

►

Excisional and incisional biopsies

►

Exposure of unerupted teeth

►

Fibroma removal

►

Frenectomy

►

Frenotomy

►

Leukoplakia

►

Operculectomy

►

Oral papillectomies

►

Pulpotomy

►

Pulpotomy as an adjunct to

►

Gingival troughing for crown impressions

►

Gingivectomy

►

Gingivoplasty

►

Gingival incision and excision

root canal therapy

►

Reduction of gingival hypertrophy

►

Soft tissue crown lengthening

►

Treatment of canker sores,herpetic and

►

Hemostasis and coagulation

aphthous ulcers of the oral mucosa.

►

►

Implant recovery

►

Incision and drainage of abscess

Vestibuloplasty

►

Tissue retraction for impression

Laser periodontal procedures, including:

►

Laser soft tissue curettage

►

Laser removal of diseased, infected, inflam ed and necrosed soft ti ssue within the

periodontal pocket

►

Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the

periodontal pocket to improve clinical indices including gingival index, gingiv al bleeding Index,
probing depth, attachment loss, and tooth mobilit y).

5400230 Rev. H

4

1.3 CONTRAINDICATIONS

All clinical procedures performed with the iLase must be subjected to the same clinical judgm ent and

care as with traditional techniques. Patient risk must always be considered and fully understood
before clinical treatment. The clinician must completely understand the pat ient 's medi cal history prior
to treatment. Exercise caution for general medical condition s that m ight contraindicate a local
procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung
disease, bleeding disorders, and immune system deficienc y , or any medical condition s or
medications that may contraindicate use of certain light/lase r type source s associated with this
device. Medical clearance from patient's physician is advisable when dou bt exists reg ar ding
treatment.

5400230 Rev. H

5

2 Precautions and Warnings

2.1 CLINICAL

PRESCRIPTION REQUIRED

:

Federal law restricts this device to sale by or on the order of a dentist or

physician or licensed practitioner.

TRAINING REQUIRED

:

Only licensed professionals who have reviewed and understood this
User Manual should use this device. Additional training from a Biolase Authorized Representat ive is
strongly recommended.

CLINICAL USE: Use your clinical judgment to determine all aspects of treatment including, but not

limited to, the laser treatment protocol, technique, power settings, pulse duration and puls e int erval
settings, mode of operation as well as the tip type and other procedural requirements. Alway s start
treatment at the lowest power setting for that specific indication and increase as required. Closely
observe and monitor clinical effects and use your judgment to determine clinical param et ers and
approach for the treatment. Make appropriate power and se t t ings adjustment s to compensate for
varying tissue compositions, density and thickness. Cutting with the iLase is a thermal process and
any transfer or accumulation of heat into adjacent structures may result in a burn and tissue
damage. Always start treatment at the lowest power setting for that specific indication and increase
as required. Be aware of the underlying and adjacent struct ures such as nerve s and blo od vessels
when cutting with this device. Do not direct laser energy towards hard tissues such as tooth or bone
or any metallic restorations. Do not direct laser energy towards metallic restorations, cements or

rd

other dental materials. Exercise extreme caution when using this laser inside the pocket, 3

molar

sockets, channels and other openings where visibility is limited.

ANESTHESIA: When treating soft tissue, anesthesia may not be necessary; patients should be

closely monitored for signs of pain or discomfort at all times. If such signs are present, adjust
settings, apply anesthesia, or cease treatment if required.

INEFFECTIVE REMOVAL OF TISSUE: Ineffective removal of tissue may be caused by improper tip

initiation (see Section 4.7) or reduction in the power output. Check with a Biolase service
representative to make sure that the iLase is functioning properly.

TIP BREAKAGE: Use a bite block to prevent accidental biting and breakage of the tip; use high-

speed suction to prevent patient inadvertently swallowing a broken tip and choking.

iLASE WINDOW: Check and clean the protective window of the fiber optic shaft with a cotton swab

5400230 Rev. H

moistened with isopropyl alcohol. CAUTION: Failure to check and clean the window will lead to reduced

optical power efficiency and permanent damage to the system (refer to S ection 7 f or maintenance
information).

6

Do not look directly into the beam or at specular reflections. Never direct
or point the beam at anyone’s eyes.

Do not use this device if you suspect it is functioning improperly or other
than described herein.

Do not aim the laser at metallic or reflective surfaces. such as surgical
surfaces create a potential hazard.

Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation exposure.

Instrument should be installed and operated according to CAN/ CSA-
Z386-08: Laser safety in health care facilities.

or point the beam at anyone’s eyes.

Plug the power supply into a grounded receptacle only. Connection t o
an ungrounded receptable may create hazardous conditions.

Do not operate this device in the presence of explosive or flammable

drawn to the danger of ignition of endogenous gases.

The single-use tips are supplied non-sterile and must be sterilized

instructions on sterilizing tips and the iLase cover.

2.2 LASER SAFETY

DANGER

WARNING

WARNING

CAUTION

CAUTION

CAUTION

CAUTION

2.3 ELECTRICAL SAFETY

CAUTION

No modification of this equipment is allowed.

All persons present in the operatory must wear protective laser
eyewear for the laser wavelength of 940nm.

instruments or dental mirrors. Laser beam reflections from these

Do not look directly into the beam or at specular reflections. Never direct

CAUTION

2.4 FIRE SAFETY

materials. Flammable anesthetics or oxidizing gases such as nitrous

DANGER

oxide (N
and flammable solutions used for cleaning and disinfecting should be

O) and oxygen (O2) should be avoided. Solvents of adhesives

2

allowed to evaporate before laser is used. Attention should also be

2.5 CLEANING AND STERILIZATION

WARNING

before use. The iLase Cover is another component that requires
sterilization. Refer to Chapter 6 “Cleaning and Sterilization” for

5400230 Rev. H

7

Doctor, patient, assistant and all others inside the operatory must wear

Biolase or your authorized dealer.

Special care must be taken to prevent infection from the laser plume

the laser procedure.

2.6 PERSONAL PROTEC TIVE EQUIPMENT

PROTECTIVE

EYEWEAR
REQUIRED

LASER

PLUME

appropriate laser eyewear protection for the laser wavelength of 940nm.
Periodically inspect laser eyewear for pitting and cracking. For
replacement or additional protective laser eyewear, please contact

generated by vaporization of virally or bacterially infected tissue. Use
high speed suction and clinical masks for protection at all times during

5400230 Rev. H

8

Model

7400040-01

3 Installation

3.1 UNPACKING

Carefully unpack the shipping container and inspect the content s. I f any parts are damaged or
missing, do not use the iLase and contact your Biolase representative imm ediat ely.

Inside the shipping container you will find the following items:

Description

Charging Station 1

Power Supply – Charging Station 1

iLase Main Body 1

iLase Cover 1

Single-Use Tips 1 Kit

iLase Cover Grips 1 Pkg

Tip Initiation Blocks 1 Pkg

iLase Rechargeable Battery 2

Laser Safety Signs 1

Laser Safety Glasses (Clinician) 2

Laser Safety Glasses (Patient) 1

iLase Cleaning Kit 1

User Manual 1

Retain the shipping container and store it in a cool dry place. Use this container if it becomes
necessary to ship the iLase to Biolase or a Biolase Authorized Service Center.

5400230 Rev. H

9

3.2 CLEANING AND STERILIZATION BEFORE USE ON PATIENTS

The iLase and accessories are provided non-sterile. The cover is reusable and must be cleaned and
sterilized between patients to avoid cross-contamination. The t ips are single-use only to avoid cros s­contamination and are designed to withstand a single sterilization cycle only; t hey must be disposed of
after single use in a biohazard medical waste Sharps container. Refer to section 6 “Cleaning and
Sterilization for complete instructions.

3.3 BATTERY CHARGING

You must charge the batteries before using the device.

►

Plug in the charging station power supply to an AC power receptacle and connect it to the charging
station as s hown below. Place the charging station on a surface where it will not be disturbed or come
in contact with liquids or contaminants.

IMPORTANT: Use only Biolase approved power supplies, P/N 6400422

5400230 Rev. H

Figure 3·1:

►

Place the batteries, either end first, in any one of the battery charging receptacles at t he

Power Supply

Attachment

top of the charging station. iLase batteries have contacts on both ends and allow pla cement into the
receptacle in either orientation. The batteries will connect aut om at ically to the charging contacts when
inserted, and the charging indicator will illuminate with an amber color to indicate that t he charging has
started. If the indicator illuminates with a green color, the battery is already charged and is ready for
use. Attaching the main body to the battery is optional, but not required to charge a battery.

The battery charging indicator on the front of the charger will display the charge condi ti on of each of the
batteries placed in the charger. If no battery is installed, the charging indicator will be off.

10

Figure 3-3:

iLase Cover

Attachment

Figure 3 - 4 :

Figure 3

-5:

Bending

the tip cannula

Allow the batteries to charge for a minimum of two hours before
first use. If the battery has been charging for more than two
hours and the indicator has not turned green, the battery might
be damaged and may need to be replaced. When the battery
charging indicator turns green, the battery is fully charged and
you may prepare the device for use.

NOTE:

Charge spare batteries for a minimum of 2 hours

before use.

3.4 BATTERY INSTALLATION

Slide a fully charged battery assembly into the socket at the
end of the main body of the iLase. A magnet inside the main
body will grip and hold the battery in place. (Battery assemblies
have contacts on both ends; it is not necessary
to orient the end of the battery when installing it). To remove

Figure 3-2: Charging Indicat ors

a battery, gently pull the battery from the socket until the
magnet releases the battery assembly.

3.5 ATTACHING A TIP

To install a tip, slide a sterile iLase cover onto the handpiece.
Make sure the cover is properly oriented and fits snug against
the button on the main body as shown in FIGURE 3-3.

Insert a sterile tip into the open end of the cover. Tighten the tip
by turning clockwise until snug. Once installed, verify that the
tip appears to extend straight from the cover.
If it appears angled, remove and re-install the tip until it
appears straight. Once properly installed, bend the metal
cannula as appropriate for the planned procedure.

CAUTION:

Correct Bend

Do not bend

the tip at a sharp angle as it may break.

Incorrect Bend

Tip

properly

installed

5400230 Rev. H

11

Doctor, patient, assistant and all others inside the operatory must wear

Biolase or your authorized dealer.

Special care must be taken to prevent infection from the laser plume

the laser procedure.

4 Operating Instructions

4.1 PERSONAL PROTEC TIVE EQUIPMENT

PROTECTIVE
EYEWEAR

REQUIRED

appropriate laser eyewear protection for the laser wavelength of 940nm.
Periodically inspect laser eyewear for pitting and cracking. For
replacement or additional protective laser eyewear, please contact

LASER
PLUME

generated by vaporization of virally or bacterially infected tissue. Use
high speed suction and clinical masks for protection at all times during

4.2 PREPARATION FOR USE

Before using the iLase, make sure the following conditions have bee n met :

►

The iLase charging station power supply is plugged into working AC power receptacle, and at least

one battery is connected to the charging station and charged for at least 2 hours.

►

The iLase cover has been sterilized using the sterilization instructions noted in Chapter 6 “Cleaning

and Sterilization.”

►

The tips that you plan to use have been sterilized using the sterilization instructions noted in

Chapter 6 “Cleaning and Sterilization.”

►

The iLase main body and battery have been disinfected by following the cleaning and disinfecting

instructions noted in Chapter 6 “Cleaning and Sterilization.”

►

The iLase has been assembled, including the cover and a fully charged batter y asse m bly.

►

A tip appropriate for the planned procedure has been installed in the iLase cover.

4.3 STARTING THE ILASE

Turn on the iLase by installing the battery.

NOTE:

To avoid Error message, do not hold the handpiece over the rubber finger grip area at any time in
STANDBY mode. If an error message occurs, simply remove your f ingers from the rubb er grip and wait unt il
message clears.

The iLase Welcome Screen is displayed.

Figure 4 -1:

5400230 Rev. H

Welcome

Screen .

12

Safety operation of laser electronic devices requires preven t ion of t he unaut horized use of
the devices. An electronic key is implemented in the iLase for that purpose. When PLEASE E NTE R
KEY appears, there is a progression bar shown for 3 seconds. Triple click the selector sw it ch (rapidly
press three times) to advance to the next screen, Procedures Menu. If the key is not entered, the
system remains on t he Welcome screen. To get back to the PLEASE ENTER KEY screen, press the
selector switch once.

Figure 4 -2: l(ey Enter Screen .

4.4 INITIAL SELECTION OF A PROCEDURE

The SELECT PROCE DURE screen will appear once the key is properly entered. Eleven preset
procedures are available; to select a procedure, scroll up or clown using the Selector Switch and press
the switch in on the desired procedure (refer to section 5.1 for a listing of procedure presets).

When you have selected a procedure by pressing the selector switch, the Tip Init iation screen will
appear with the preset values for that operation: 1. 4 W, continuous or CW mode.

After two seconds, the system will enter Ready mode and the laser will be ready for firing by pressing
on the rubber grip to initiate the tip. After completing the initiation of the tip, press down the selector
switch to start the procedure using the selected presets.

4.5 SYSTEM MODES

STANDBY MODE: For all operations leading up to the firing of the laser, t he system has remained i n
STANDBY Mode (as noted by the amber LED in the iLase display). I n S TA NDB Y Mode, the user has

5400230 Rev. H

the ability to select a new procedure, modify settings for the procedure, and make any other changes
necessary. In this mode, the laser is disabled from accidental firing. A ctuat ion of the finger switch will
be indicated by the error symbol E05 (refer to section 8.2 for a full listing of error messages). If the
selector switch is pressed in for longer than 1.5 seconds or if the iLase is inactive for more than three
(3) minutes, it will go into SLEEP mode.

READY MODE: When a procedure is selected or when you have made any needed adjustments and

are ready to perform a procedure, place the system into READY m ode by pressing down t he selector
switch. When the iLase is in READY mode, the LED will be green. Only in this mode is the red aiming
beam activated and the laser can be fired. While in READY mode, you may adjust the power only. In
order to save modified settings to a pre-set procedure, press in and hold the selector switch for

13

When the tip is straight, the

When the tip is bent, the

Fi g

ur e 4

-3:

Ai ming beam patt

ern

.

1.5 seconds. SAVED will appear on the screen indicating that your modifications are saved under the

current procedure name. You must ensure that all safety precaution s have been f ollowed prior to
entering READY mode. (See Section 2 “Precaution s and W arning s”). The s ystem will return to
STANDBY mode when it is inactive for more than three (3) minutes.

SLEEP MODE: The system is placed in a low power state to conserve battery power. Al l LED's and

the Display panel are turned off in this mode. The system will enter STANDBY mode with the last
settings used when the Selector Switch or Finger Switch is pressed.

4.6 FIRING THE LASER

EMERGENCY

STOP

To immediately stop laser emission, pull the battery from the iLase main
body.

NOTE

Most procedures require tip initiation before using the iLase. For those procedures that require tip
initiation, you must complete the tip initiation steps before using the iLase in a procedure on a patient. If tip
initiation is not required or has already been initiated, press the selector switch to bypass t his operation.

1

Make sure the iLase has a tip installed that is appropriate for the planned proc edur e.

2

Make sure that all personnel in the operatory are wearing laser prot ective ey ewea r.

3

After the user enters READY mode, the LED on the iLase will be green. The red aiming beam will

also appear at this time. The laser is now ready to fire.

4

Prior to firing, verify that the tip is installed correctly into the iLase cover by shining the red

aiming beam onto a bright surface, such as a white table top. If using a tip that requires initiati on (not

pre-initiated), make sure the aiming beam image appear s a s in the example below:

aiming beam will look like a
circle, outlining the area
where the main laser power
is applied

.

aiming beam will more like a
spot, and the main laser
power (invisible infrared
radiation) will be applied in the
middle of the spot

.

WARNING:

When the aiming beam is not present or has a significantly different shape, change the tip

and inspect / clean the protective window until the image appears as shown above.

5

Use the aiming beam to position the tip over the target t reatment area. P lace the laser t ip on t he

treatment area and press the finger switch (or gently squeeze the finger grip) on the iLase to fire

the laser. Actuation will occur when the finger grip is pressed over any one of the six ridges anywhere

5400230 Rev. H

along the whole length of the switch.

14

6

The iLase will immediately emit a "beep" tone, then after a 0.3 second delay, the laser will

fire. Laser firing is indicated by a blinking green LED and pulsing beep sound.

7

Release the finger switch to stop laser emission.

4.7 TIP INITIATION INSTRUCTIONS

VERIFYING THE TIP

Prior to initiating the tip, verify that it is installed correctly into the iLase co ver (see previous section).
The Tip Initiation Aid screen appears as you enter Ready Mode [1.4W / CW]. You will need to have

the Tip Initiation Block handy to perform this step.

Figure 4 -4: Tip In

Touch the tip to the surface of the tip initiation block, without firing. Fire the laser by gently squeezing

itiation

Screen

.

the finger grip, allowing the tip to sink into the block. Pull the tip out when the metal cannula touches
the block, still firing until just before the tip is out of the block. Fire the laser into the air once. You will
see a white flash or a glowing tip. A glowing tip indicates that the tip is ready for use. During a
procedure, there is a chance the tip can lose its initiation; repeat the tip initiation procedure, if
necessary.

When you have finished the tip initiation, you are ready to begin the procedure. Press the Selector
Switch to move to the Main Screen while keeping the system in Ready Mode.

4.8 MAIN SCREEN

The Main screen shows the current settings of the iLase.

►

The top left corner of the screen displays the battery power level.

►

The top center of the screen displays the name of the currently selected procedure.

►

The Pulse Mode icon (lower left) indicates the currently selected pulse mode.

►

The Power icon (lower center) indicates the current laser power setting (average output

power).

5400230 Rev. H

15

While in READY mode, you may adjust the power level at any time during the procedure by toggling
up (+) or down (-) the selector switch; however, the pulse mode may not be changed in REA DY m ode.
You must return to STANDBY to change the pulse mode.

When your procedure is complete, press the selector switch on the iLase to enter ST A NDBY
mode. The LED on the iLase will turn an amber color. The system is now in STA NDB Y mode. Y ou
can modify and save new settings for the Procedure by changing power value s and pre ssing and
holding the selector switch for approximately 1.5 seconds while in READY mode.

NOTE:

Pressing the finger switch for 60 seconds while firing will cause the laser to stop firing. To

continue firing, release the finger switch and then press again.

4.9 SELECTING A DIFFERENT PROCEDURE

While in Standby mode in the Main Screen, highlight the P rocedu re Name u sing t he up (+) motion of

the selector switch, and make your selection by pressing the finger switch. The procedure screen will
be displayed.

Scroll up (+) or down (-) to select a new procedure, or select your own Custom sett ing.

After a new procedure is selected, the system will go to the Tip Initiation and Main screens in READY

mode. Switch to STANDBY mode If you need to continue modifying the preset.

4.10 SELECTING A PULSE MODE

While in Standby mode in the Main Screen, highlight and select t he pulse mode icon to ac ces s the

Pulse Mode menu; one of three available pulse modes can be chosen from that m enu by using t he

selector switch.

5400230 Rev. H

Figure 4 -7:

For a pulse that is 0.1ms on, followed by 0.2ms off, select CP1.

For a pulse mode that is 1.0ms on, followed by 1.0ms off, select CP2

Pulse

Mode Selection

Screen.

.

For continuous wave ouptut (not pulsed), select CW.

Return to the main screen by selecting one of the available pulse modes

.

16

4.11 ADJUSTING LASER POWER

If you wish to change the power setting, highlight and select the power icon in the Main Screen in

STANDBY mode to display the Power Setting screen. The figure below does not show a power
setting, but rather has "[X.X] W" to indicate the numeric format of the average power set t ing.

The Power Setting screen displays the current laser output power sett ing in bot h P eak and Average

Power values and allows you to adjust the power up (+) or down (-).

Using the selector switch, scroll up to the " + " sign to increase the power; scroll down to the " - " sign
to decrease the power. The power setting increases or decreases by one increme nt eac h t im e t he
selector switch is scrolled. When the power setting has reached its upper or lower limit, the value will
remain at the limit.

Press the selector switch to return to the main screen. You can also access the Settings Menu from
this screen. For further details of the Settings Menu refer to the Maintenance section of this manual.

Fi gure 4

-8:

Power Setti ng

Screen

.

5400230 Rev. H

17

Tip

Initiation●

Power

Power

Length

Interval

CP1

CP2

CP2

CP2

CP2

CP2

CP2

Exposure of Unerupted

CP2

9

Aphthous Ulcer

No

0.70W

0.70W

CW

10

Hemostasis

No

0.50W

0.50W

CW

11

Endo

(*)

0.10W

0.10W

CW

12

Custom 1

(*)

0.10W

0.10W

CW

13

Custom 2

(*)

0.10W

0.10W

CW

5 Clinical

5.1 PRESETS

iLase has 11 pre-programmed settings, plus 2 open slots to allow the user to set and store
customized settings.

Preset Name

Peak

1 Gingivectomy Yes 3.00W 1.00W

2 Troughing Yes 2.00W 1.00W

3 Excision Yes 1.80W 0.90W

4 Frenectomy Yes 2.00W 1.00W

5 Implant Recovery Yes 2.40W 1.20W

Average

Pulse

(0-10ms)

(1.00ms)

(1.00ms)

(1.00ms)

(1.00ms)

Pulse

0.20ms

1.00ms

1.00ms

1.00ms

1.00ms

6 Crown Lengthening Yes 1.80W 0.90W

7 Perio Pockets Yes 1.60W 0.80W

8

Not required for pre-initiated tips

●

(*)

Minimum defaults provided for user setting of Endodontic Procedures such as Pulpotomy and Pulpotomy

Teeth

Yes 1.80W 0.90W

(1.00ms)

(1.00ms)

(1.00ms)

1.00ms

1.00ms

1.00ms

as an adjunct to root canal therapy

►

Hemostasis require a defocused mode of application.

5400230 Rev. H

The first 8 procedures listed are performed in contact mode. Aphthous Ulcer and

18

►

300µm tips are recommended for removing less fibrous tissue types. 400µm tips

are recommended for removing fibrous tissue and inside the pocket.

►

All of the procedures listed require tip initiation except for Hemostasis and Aphthou s Ulcer.

►

For information on how to initiate the tips that are not pre-initiated, please refer to the Tip

Initiation Instructions provided in Section 4.

5400230 Rev. H

19

6 Cleaning and Sterilization

6.1 CLEANING AND DISINFECTION

CAUTION:

During use the internal components of the iLase under the cover may become hot to the touch.

Allow the iLase to cool for a few minutes before removing the cover for cleaning and sterilization.

The iLase must be cleaned prior to use on each patient.

Cleaning must be performed within a

maximum of one (1) hour after the procedure, and prior to sterilization.

recommended.

Manual cleaning is

Prepare a cleaning solution per the manufacturer’s instructions. Use a commer cially available
surgical instrument detergent/enzymatic cleaning solution with a pH of 7.0, such as Enzol®, or a
similar enzymatic presoak and cleaner. Follow the instructions for disposal of used solution.

To disinfect the iLase main body and battery, perform the following steps in the indicated order:

Place the iLase in STANDBY mode.

1

2

Wear protective gloves and eyewear when handling the cont am inat ed m ain body and b at t ery.

3

Remove the used tip from the cover (if present) and dispose of in a biohazard medical waste

Sharps container.

4

Remove the battery from the main body and set it aside.

5

Pull the iLase cover forward and slide it off the body of the main body.

6

To disinfect the main body, wipe with an appropriate disinfecting solut ion, such as Ca vid ice® or a

similar quaternary ammonium compound product (containin g 20% alcohol or less) and follow the
manufacturer’s instructions.

CLEANING THE COVER

1

Rinse the cover under lukewarm water (22 - 43º C) for a

2

Soak a piece of gauze in the cleaning solution and wrap the handpiece co ver. Lea ve it

minimum of 10 seconds

to remove gross soil.

wrapped for a minimum of 10 minutes. Unwrap, and using a soft-bristled brush dipped in the
cleaning solution, gently brush the cover for

3

Rinse the cover under lukewarm running tap water (22 - 43º C) for a minim um of 10 second s and

at least 15 seconds

.

dry with a lint-free cloth.

4

Visually inspect the cover for any residual soil. If present, repeat steps 1 through 3 until residual

soil is removed.

5400230 Rev. H

20

121°C ( 250°F)

20 minutes

0 minutes

132°C (270°F)

15 minutes

15-30 minutes

132°C (270°F)

134°C (EU only)

Figure 6–1: Disassembly for Disinfection, Cleaning, and Sterilization

6.2 STEAM STERILIZATION OF HANDPIECE COVER AND TIPS

The steam sterilization process is intended to destroy infectious microorga ni sms an d pat hogens.

NOTE:

Always perform the procedure immediately after cleaning and prior to use and only use FDA­cleared (USA) or CE-marked (Europe) sterilization accessories, i.e., sterilization pouch and autoclave
tray.

1

Place the handpiece cover and/or tips inside separate single-wrap, self-sealed steriliz at ion

pouch(es).

2

Place the pouch(es) on an autoclave tray. Do not stack other instruments on top of the pouches.

3

Place the tray into the autoclave chamber and set appropriate cycle as recommended b elow:

Type of Sterilizer Temperature Min Time Drying Time

Gravity Displacement

Dynamic-Air-Removal

(Pre-Vacuum)

4 minutes 20-30 minutes

4 When cycle is complete, the handpiece cover and tips must remain in the sterilization pouches until

used to maintain sterility.

5

To assemble the components when ready to use, slide the cover over the handpiec e mai n body and

push it toward the window until you it ‘clicks’ into position. Install the tip and connect the battery as
detailed in Section 3 of this User Manual.

5400230 Rev. H

21

6.3 DISPOSAL

TIPS

Tips are designed to be used one time only and must be sterilized prior to each use. Proper tip
disposal in a biohazard medical waste Sharps container is required. Do not reprocess tips.

BATTERIES

Lithium ion batteries contain toxic materials and should not be disposed of in l andfi lls or incinerators.
Dispose of depleted batteries as directed by your local solid waste handling regulations. If you have
questions or need advice about safe disposal of used batteries, contact Biolase or your Biolase
Authorized Service Representative.

DEVICE AND PARTS

The iLase is a medical device subject to regulations gover ning it s disposal. Contact Biolase or your
Biolase Authorized Service Representative for instructions on returning the device to Biolase for
disposal. Do not dispose of an iLase or its parts in landfills or incinerators.

5400230 Rev. H

22

7 Maintenance

Check and Clean Laser Aperture

Grip

Alignment

Tabs

7.1 REGULAR MAINTENANCE

Do not use bleach or abrasive cleansers on any surfaces of the main body.
Return the iLase to the charging station for recharging between procedures or when t he low-battery

indicator is illuminated.
Periodically check the laser aperture for contamination. If

the aperture appears contaminated, wipe with a cotton
swab moistened with isopropyl alcohol until clean. The
iLase cover must be removed from the main body to be able to access the laser aperture for cleaning.

WARNING:

Failure to clean the aperture when contaminated, will lead to reduced optical power effici ency
and permanent damage to the system. To prevent apertur e contamination, please keep the tip plug or
protective cover attached to the handpiece when not in use.

7.2 iLASE COVER GRIP REPLACEMENT

Although the iLase cover is designed to survive repeated autoclave sterilizati on c ycles, i ts rubber grip
may become worn or damaged through repeated use. The grip has been design ed t o be replac eable
by the user if it becomes necessary. The iLase system is shipped with two additional grips for this
purpose.
To replace the rubber grip, remove the iLase cover from the main body. Slide the old grip off of the
small end of the cover and slide a new rubber grip onto the same end with the large end of the grip
first. Ensure that the grip alignment tabs on the grip snap into the grip alignment holes on the cover,

bel

as shown

ow:

5400230 Rev. H

Figure

7-1: Cover Grip

Alignment

23

● English

● French

● German

● Russian

● Italian

● Portuguese

● Spanish

● Chinese (Mandarin)

● Korean

● Japanese

7.3 SYSTEM CONFIGURATION

The Settings Menu screen allows you to adjust the settings of the user interface. The S ettings Menu
is entered by pressing and holding down the selector switch for approximately 1.5 seconds when in
the Main Screen while in Standby mode.

Figure 7-2:

The following screens are available in the Settings Menu:

►

Aiming Beam: To modify the aiming beam brightness.

►

Restore All: To restore all procedures and preferences to their default settings.

►

Language: To select from the available languages

►

Exit: To exit the Settings Menu

Aiming Beam allows you to adjust the brightness of the aiming beam. To change the bri ght ness,
select the

Increase

or

Decrease

the lowest setting and level 3 is the highest at 1mW output. Level 2 is the default setting.
The Restore All button will reset the aiming beam brightness. preset values, and language selection

to their default settings.
The Language selection will enable selection from up to 10 different languages.

Settings

Screen (A

iming beam currently s

.

hown)

arrow icons. The aiming beam has 3 brightness settings: level 1 is

5400230 Rev. H

24

8 Troubleshooting and Repairs

Figure 8-1:

Fi nger

Switch Actuated.

8.1 TROUBLESHOOTING

The following tables list warning and error messages which indicate conditions that can u sually be
remedied by the user. If the recommended corrective action does not solve the pro blem and t he
message persists, restart the iLase by removing the battery, waiting 5 seconds. and then re-installing
the battery. If the error message reappears after restarting the iLase, the system cannot be used until
the cause of the error has been remedied. Call Biolase Service at [phone] or your B iolase
Authorized Service Representative.

8.2 WARNING AND ERROR MESSAGES

The Warning and Error screens display codes and recommended co rre ctive actions. If a Warning or
Error message is displayed, perform the indicated correctiv e action

.

Error/Warning Code Error/Warning Description Action

E01 Temperature Sensor open
(check at start up)

E02 Temperature Sensor short
(check at start up)

Call Service

Call Service

E03 Laser system overheated Wait to cool off

E04 Laser current is outside of

allowed range

E05 Finger switch actuated in
STANDBY mode

E06 Up/down/select switch
stuck

E07 Check Sum Error
(memory integrity)

Call Service

Release Finger Switch

Call Service

Call Service

W01 Warning temperature Wait to cool off

W02 Warning low battery level

5400230 Rev. H

Battery replacement may be

necessary

25

8.3 REPAIRS

There are no user-serviceable parts in the iLase. Do not open any part of the device or attem pt t o
make repairs. Doing so may expose the user to unsafe voltages, high temperatures, or laser energy
and may void the product's limited warranty.

To obtain repair service for your iLase, call Biolase Service at 1-800-321-671 7 or your B iolase
Authorized Service Representative.

5400230 Rev. H

26

9 Laser Calibration

9.1 LASER CALIBRATION

Biolase recommends that a laser calibration be performed ever y 12 months t o ensure t hat t he laser
output power corresponds accurately to the displayed power. Annual calibrations can be performed at
a Biolase Authorized Service Center.

Call Biolase Service at 1-800-321-6717 or contact your Biolase Authorized Service Representative to
schedule an appointment.

5400230 Rev. H

27

10 Specifications

iLase Handpiece with surgical tip and battery

attached (Length X Diameter)

Power Supply (W X D X H)

1.77” X 2.36” X 2.26” / 4.5 cm X 6.0 cm X 6.0 cm

iLase Charging Station PowerSupply and cord/plug

set

Discharge over current sensor and resettable circuit

breaker

Dimensions

Charging Station (W X D X H) 4.7” X 4.0” X 2.8” / 11.9 cm X 10.2 cm X 7.1 cm

8.1” X 0.75” / 20.5 cm X 1.90 cm

Weight

iLase Complete System 1.89 lbs / 0.86 kg

iLase Charging Station 0.87 lbs / 0.34 kg

iLase with Battery attached 0.22 lbs / 0.10 kg

0.62 lbs / 0.28 kg

Electrical

Voltage (to power supply) 90 – 230 VAC

Amperage (max) 0.8A

Frequency 50 – 60 Hz

Electrostatic Discharge Immunity Up to 10 KV (per IEC 60601)

Battery Lithium ion 3.7 V 800 mAh

Recharge Time (fully discharged) 2 hours

Safety

Laser

Laser Class IV (4)
Wavelength 940 nm ± 10nm

Output Power 3.0 W Max CW / 5.0 W Peak Power (Pulse Mode)

Power Accuracy ± 20%

Pulse Duration Continuous | 0.1 ms | 1 ms

Pulse Interval -------------- | 0.2 ms | 1 ms
Aiming Beam Laser diode, max 1 mW, 625-670nm, Class 1

N.O.H.D. 2.61 meters

Environmental

Temperature - Operating 68° – 77° F (20° – 25° C)

Temperature - Storage 59° – 90° F (15° – 35° C)

Humidity - Operating 15 – 95 % non-condensing

Humidity - Storage 10 – 70 % non-condensing

Altitude - Operating maximum 10,000 ft (3048 m)

Altitude - Storage maximum 12,000 ft (3658 m)

5400230 Rev. H

28

11 Labels

11.1 LABELS

The iLase is labeled as indicated in the following table. Refer to Figures 11-2 for label locations.

Label Description Location

Product ID Label

Charging Station, rear.

Refer to Section 11-2.

Certification Label

Laser Warning Label

Laser Aperture

Charging Station, underside.

Refer to Section 11-2.

Charging Station, rear.

Refer to Section 11-2.

Handpiece near battery end.

Refer to Section 11-2.

5400230 Rev. H

11.2 LOCATION OF LABELS

Instruction and warning labels are affixed to the device in the locations shown.

BIOLASE, Inc.
4 Cromwell
Irvine, CA 92618 USA

949.361.1200

888.424.6527
biolase.com

About BIOLASE

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

and dentistry that feature proprietary and patented technologies for

minimally invasive surgeries, reducing pain and improving clinical

results.

MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert/Germany
[phone]
mt-procons.com

Only BIOLASE combines the leading laser technology – continuously

improved through ongoing clinical R&D and engineering – with

unmatched training, practice integration support and service.

BIOLASE leads the global dental laser market with over 21,000 lasers in

use today and the most complete family of dental lasers – from diode

lasers to the most advanced all-tissue laser, the WaterLase iPlus™.

Made in the USA

©201 4 BIOLA SE, Inc. All r ights rese rved.

™

iLase™ User Manual P/N 5400230 Rev. H