Picasso and Pacasso Lite Operating Instruction Manual Ver 5 Oct 2010

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AMD LASERS®, LLC. Operating Instructions Manual

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OIMv5 10-10 r4

OIMv5

0197

ISO 13485

For EU only

Note for Canadian Applications:

The device should be installed and operated in accordance with CAN/CSA-Z386-92:

Laser Safety in Heath Care facilities.

Information in this document is subject to change without notice.

©2010 AMD LASERS®, LLC. All rights reserved.

www.amdlasers.com

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OIMv5 10-10 r4

Laser - Picasso Lite

Other Light Sources – Picasso | Picasso Lite

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

Contraindications

Warnings

Eyewear

Anesthesia

Adjacent Structures

Suction

Training

CLINICAL APPLICATIONS

Introduction

Indications of Use:

MAINTENANCE

Annual Maintenance

Daily Maintenance

Contamination Control Procedures

Cleaning Instructions for Picasso | Picasso Lite Strippable Fiber Handpiece and the Fiber Optic Cable

High-level Disinfection Instructions for the Fiber Optic Cable

Steam Sterilization for Picasso | Picasso Lite Surgical Handpiece

Transportation

Storage

CALIBRATION

EQUIPMENT NEEDED

Picasso

Picasso Lite

Calibration schedule

APPENDIX A – LABELS & DESCRIPTIONS

Label Positions

Label descriptions

APPENDIX B – PARTS AND ACCESSORIES

Picasso | Picasso Lite DESCRIPTION

APPENDIX C – (LIMITED WARRANTY)

APPENDIX D – (LIMITED LIABILITY)

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- 18 - 18 - 19 - 19 - 19 - 19 - 19 - 19 - 19 - 19 - 20 - 20 - 20 - 21 - 21 - 21 - 21 - 21 - 21 - 22 - 22 - 22 - 23 - 23 - 23 - 23 - 24 - 25 - 26 - 26 - 27 - 27 - 28 - 29 -

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AMD LASERS®, LLC. Operating Instructions Manual

INTRODUCTION

The Picasso line of soft tissue dental lasers is designed for a wide variety of oral soft tissue and tooth

whitening procedures. Picasso | Picasso Lite lasers utilize solid state diodes as a laser energy source.

The energy is delivered to the operating area by means of a delivery system consisting of a flexible

fiber connecting the laser source and the handpiece. The device is activated by means of a

footswitch.

Picasso | Picasso Lite lasers are intended for use by authorized dental professionals in oral soft tissue

and tooth whitening procedures. The use of these devices requires proper clinical and technical

training. This manual provides instructions for professionals that have completed the appropriate

training.

When used and maintained properly, Picasso | Picasso Lite lasers will prove a valuable addition to

your practice. Please contact your authorized representative or AMD LASERS®, LLC if you have any

questions or require assistance.

SAFETY

Precautions

Failure to comply with the precautions and warnings may lead to exposure to dangerous voltage

levels or optical radiation sources. Please comply with all safety instructions and warnings.

CAUTION: Use of controls or adjustments or performance of procedures other than those specified herein

may result in hazardous radiation exposure.

CAUTION: These units have been designed and tested to meet the requirements of electromagnetic,

electrostatic, and radio frequency interference testing. However, the possibility of electromagnetic or

other interference may still exist.

DANGER: DO NOT USE THIS UNIT IF YOU SUSPECT IT OF FUNCTIONING IMPROPERLY OR OTHER THAN DESCRIBED HEREIN.

Safety Instructions

Follow these safety instructions before and during treatments:

• All operatory entrances must be marked with an appropriate warning sign.

• Do not operate in the presence of explosive or flammable materials.

• All persons present in the operatory must wear protective eyewear.

CAUTION: Periodically inspect eyewear for pitting and cracking.

Note: For replacement, additional or prescription protective eyewear, please contact your

authorized service representative or AMD LASERS®, LLC.

• Do not look directly into the beam or at specular reflections.

• Never direct or point the beam at anyone’s eyes.

• Remove or cover all highly reflective items in the treatment area.

• Press STANDBY (Standby button) on the control panel before turning off unit.

• Always press STANDBY on the control panel before exchanging handpieces or removing

the fiber optic connector from the unit.

• Move the circuit breaker (located on rear panel) to OFF (0) position and remove the key

before leaving unit unattended.

DANGER:

VOIDED.

DO NOT OPEN UNIT HOUSING AT ANYTIME. DANGER FROM HIGH VOLTAGE MAY EXIST AND WARRANTY IS

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OIMv5 10-10 r4

NOTE: Please be aware that metal/plastic cannula may become hot during use. Avoid contact of

cannula with tissue.

Safety Features

Energy Monitor

Measures and verifies power output. Power deviations of more than 20% from the selected value

will cause the display to show either error message “DIODE CALIBRATION”, or “LASER POWER”

(Picasso Only).

The unit will not operate until the system is reset by pressing any key on the keypad. If error

messages persist, please contact your authorized service representative or AMD LASERS®, LLC.

Circuit Breaker

Serves as a line switch to separate the unit from the main power supply (0 = OFF, ‫ = ׀‬ON)

System Monitor

The system monitors emergency stop switch, remote key, footswitch attachment, fiber attachment,

and output power. An error in any one of these will stop the system.

Keyswitch

The unit can only be switched ON (key in horizontal position) with the proper key. Always turn unit

OFF (vertical position) and remove key when not in use.

READY Button

Once the circuit breaker and keyswitch are set to the ON position, the READY button on the keypad

must be pressed to enable the footswitch. One beep will sound to indicate that the system is ready

for use.

Footswitch

Picasso | Picasso Lite will not emit laser energy until the user presses down on the footswitch.

Emergency Stop

Press the red Emergency Stop button to instantly turn off the unit. The button will be in the out

position. To reset the Emergency Stop button, simply press again. The button will be in the pushed in

position for normal operation. Do not use the Emergency Stop for normal stops.

Remote Interlock

This feature allows the device to be connected to the remote sensor, which will prevent its operation

when triggered (i.e., by opening door). The remote interlock plug must be inserted for normal

operation.

Functional Display

The System Text Display (Picasso only) and the Light Emitting Diode (LED) indicators on the front of

the unit and control panel show the functional conditions of the system.

Safety Questions

Please direct any safety questions to an authorized representative or AMD LASERS®, LLC.

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AMD LASERS®, LLC. Operating Instructions Manual

Safety Classification

The following safety classifications are applicable to the Picasso | Picasso Lite devices:

•

•

•

•

•

•

Laser Radiation – Class 4 (US classification)

Type of protections against electrical shock – Class 1 (US classification)

Degree of protection against electrical shock – Type B Applied Part

Not protected against water ingress – Ordinary Equipment

Not suitable for use in presence of flammable anesthetic mixture

Operation Mode – Continuous Operation

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OIMv5 10-10 r4

EQUIPMENT DESCRIPTION

General

Components

• Delivery System (FIGURE 1)

• Console (FIGURE 2 and 3)

Handpiece used with strippable fiber

Multi-Tip Handpiece used with disposable tips

FIGURE 1

Item#

1

FIGURE 2

Item

Item Description

CONTROL PANEL

Displays and controls the parameters, such as power output,

presets, aiming beam intensity, and speaker volume.

2

EMERGENCY STOP BUTTON

3

4

5

6

7

HANDPIECE AND TIPS

HANDPIECE HOLDER

FIBER SPOOL

KEYSWITCH

AC ADAPTER

8

9

CIRCUIT BREAKER

REMOTE INTERLOCK

CONNECTOR

FOOTSWITCH CONNECTOR

POWER SUPPLY CONNECTOR

FIBER CONNECTOR

Disables the unit in the event of an emergency. Push once to

disable Picasso | Picasso Lite. Push again to enable.

Handpiece and optional tips for a variety of operation

Holds handpiece when not in use

Stores fiber

Turns display of the unit ON and OFF

Connects the unit and net power supply

Input: 100-240 V 50-60Hz

Output: 9V--3A

Master ON/OFF switch

Connects interlock to the unit

10

11

12

Connects footswitch to the unit

Connects power supply to the unit

Connects fiber to the unit

[2]

[3]

[4]

[1]

[8]

[6]

[5]

[9]

[11]

[10]

[12]

FIGURE 3

[7]

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AMD LASERS®, LLC. Operating Instructions Manual

Picasso | Picasso Lite Setup

For Details refer to "Quick Start Guide" (Figure 4). See

page 7 for identification of components.

1. Place unit in a clean, dry, and well ventilated area.

2. Verify circuit breaker is in OFF position.

3. Connect key into key switch. Verify it is in the OFF

position.

4. Verify Emergency Stop button is disengaged (UP

position).

5. Connect footswitch.

6. Connect remote interlock.

7. Connect power cord to power connector on unit and plug into wall outlet.

8. Connect fiber into fiber connection port.

9. Program Presets (see “Programming Presets”, page - 11 -).

10. Set up Delivery System handpiece and fiber (see page - 14 -).

11. See Operation Instructions on page - 17 -.

FIGURE 4

Control Panel Picasso

2

1

3

4

5

6

FIGURE 5

7

8

1. CONT/REP: Continuous

or Repeating

Modes

2. PRESETS:

1,2,3,4

3. POWER:

0.1-7W

4. INTERVAL:

20ms – 9.9 secs increments of .1ms

5. DURATION:

20 ms – 9.9 secs, setting increment is .1ms

6. SETTINGS:

Language Selection | Aiming Beam Settings | Volume Settings

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OIMv5 10-10 r4

7. STANDBY/READY:

8. SAVE:

Standby/

Save button

Ready button

FIGURE 6

Language

anguage se

selection

Seven languages can be selected (Figure 6):

• English

• Spanish

• Portuguese

• Korean

• Japanese

• Russian

• Chinese

English is the default language.

To select another language, press

button. The system will then enter into the language

selection display (Figure 5). Press

ress desired language for 2 seconds

seconds, and the system will restart in the

chosen language

AIMING BEAM brightness settings

To select the brightness for aiming beam, press

the brightness settings.

5 steps: Off->Weakest->Weak->Strong

>Strong ->Strongest

button. Press the

button to change

VOLUME settings

To select the volume of the unit, press the

button. Press the

volume settings.

5 steps: Mute->Quiet->Normal->Loud

Loud ->Very Loud

button to change the

Setting Picasso

Custom Presets

The user is able to select POWER, INTERVAL, DURATION, CONT, or REP modes according to the

operation. Pressing the SAVE button stores the selected parameters to PRESETS 1-4.

1 The data is

saved when the confirmation beep sound is heard. User can select the desired mode by selecting

number 1-4.

Programming Presets

STEP 1: Select desired type of laser operation mode: Continuous

or Repeat

.

Continuous mode - In this mode

mode, INTERVAL and DURATION are not available. POWER is able to be

selected and saved as a preset.

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AMD LASERS®, LLC. Operating Instructions Manual

Repeat mode - In this mode, all the parameters (INTERVAL, DURATION, and POWER)) can be adjusted

and saved as a preset. Use the

and

sec.

and duration from 20ms to 9.9 sec

buttons (Figure 5, #4 and #5) to select desired interval

STEP 2: Select desired preset 1-44 (Figure 55, #2)

STEP 3: POWER.. Select desired power settings 0.1 – 7 watts using the

#3).

and

buttons (Figure 5,

STEP 4: INTERVAL / DURATION.. Select desired interval and duration (figure 5, #4 and #5) (available

only on REP

mode).

STEP 5: SAVE.. Save desired settings by pushing the SAVE

heard (Figure 5, #8).

button for 2 seconds until the beep is

STEP 6: READY. Push STANDBY button (Figure 5, #7) to put unit into READY mode.

Press the footswitch to fire the laser.

STEP 7:: Repeat steps 1 through 6 to program additional presets.

Control Panel - Picasso Lite

1

2

3

7

4

8

5

9

6

1.

2.

3.

4.

5.

6.

7.

8.

POWER DOWN

POWER UP

POWER DISPLAY

SPEED MODE

SUPER PULSE COMFORT MODE

DECONTAMINATION

AIMING BEAM SETTING:: 3 steps:

VOLUME SETTING:

3 steps:

9.

STANDBY / READY

Off-> Low->High

Off-> Low->High

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OIMv5 10-10 r4

TROUBLESHOOTING – PICASSO LITE

REMOTE INTERLOCK ERROR - Two horizontal lines on

the bottom of the Power Display and a constant

beeping sound indicate that the Remote Interlock is

not in place,, is inserted incorrectly,

incorrectly or that the

Footswitch and Remote Interlock connections have

been reversed.

Solution: Verify that the Remote Interlock and

Footswitch connectors haven’t been reversed.

Remove and re-insert the Remote Interlock.

nterlock.

FOOTSWITCH ERROR - Two horizontal lines in the

middle of the Power Display and constant beeping

sound indicate that Footswitch is not connected or

that the connector is inserted incorrectly.

incorrectly

Solution: Connect the Footswitch.

POWER SETTINGS AND USE

CUTTTING AND COAGULATING SOFT TISSUE

Cutting and coagulating soft tissue procedures can be utilized with the standard handpiece and fiber

and at a range between 0.5 WATTS to 2.5 WATTS on either REPEAT or CONTINUOUS MODES.

Operator should try to use the least amount of power (WATTS) to achiev

achieve

e desired results.

TOOTH-WHITENING (Picasso only)

Tooth whitening should be performed on single teeth at a distance of 10 mm at 7.0 WATTS in the

CONTINUOUS MODE for 9.9 seconds per tooth with the standard hand

hand-piece

piece and fiber (uninitiated),

or as indicated

ated with the directions for bleaching materials as indicated by the manufacturer.

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AMD LASERS®, LLC. Operating Instructions Manual

Delivery System - Strippable Fiber

NOTE: The fiber optic cable, handpiece, and tips are shipped non-sterile.

The Delivery System consists of:

• Fiber Optic Assembly

NOTE: The standard fiber optic cable assembly is a 400

400µm fiber. Other sizes are available upon

request.

• Handpiece

• Accessories: Adapter (To be used with Disposable/Bendable Tip)

• Picasso | Picasso Lite Handpiece Kit

NOTE: The fiber optic cable, handpiece, an

and tips are reusable accessories that require cleaning and

sterilization beforee and after each use. For instructions on cleaning and sterilization of the fiber optic

cable, handpiece, and tips,, refer to section “MAINTENANCE” (see page - 21 -). Fiber

ber optic cable is not

autoclavable unless labeled as “autoclavable

autoclavable.”

Picasso | Picasso Lite Handpiece

1) Handpiece Base

1

2) Handpiece Handle

3) Handpiece Tip

2

3

4) Adapter

5) Cannula*

FIGURE 7

* Customer supplied disposable tip (18 gauge or larger)

To connect handpiece

andpiece to fiber optic assembly:

1. Loosen handpiece base (FIGURE 8)

2. Slide fiber through handpiece

andpiece base, handle

and tip

3. Approximately 3-4 inches (appx.7

appx.7-10 cm) of

fiber should protrude

4. Strip and cleave fiber (FIGURES 11 and 12)

See directions Page - 15 5. Adjust to desired length

6. Gently tighten handpiece base

ase to secure

sec

the

fiber

FIGURE 8

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OIMv5 10-10 r4

Delivery System - Multi-Tip

Tip Handpiece

The delivery system used in conjunction with removable and disposable tips consists of the Multi-Tip

Handpiece/fiber assembly (FIGURE 9):

FIGURE 9

The disposable tips (FIGURE 10)) are for single use only. The advantage of a disposable tip over the

traditional strippable and cleavable fiber is reduced set-up time since no stripping or cleaving of fiber

is necessary. To install a disposable tip, simply slide the tip over the handpiece until the tip is fully

seated. The tip initiation procedure is the same as in the case of traditional fiber (refer to the Quick

Start Guide).

FIGURE 10

The Quadra Tip

The Quadra Tip (FIGURE 11) is used in conjunction with the M

Multi-Tip

Tip Handpiece. To use the Quadra

Tip,, simply slide it over the end of tthe Multi-Tip

Tip Handpiece. For instructions on bleaching, please

refer to the application instructions supplied with tthe

he Bleaching Gel. Please note that the Quadra Tip

is not autoclavable.

FIGURE 11

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AMD LASERS®, LLC. Operating Instructions Manual

DIRECTIONS FOR STRIPPING AND CLEAVING PICASSO | PICASSO LITE FIBER

Picasso fiber should be cleave/scribed after each procedure.

To cleave/scribe the fiber:

1. Loosen the proximal end of the handpiece by unscrewing the handpiece base (Figure 8).

2. Push fiber optic cable into the base of the handpiece until fiber appears from the tip. Pull

fiber approx. 3-4 inches (appx.7-10cm) out of the tip.

3. Select a fiber stripper that corresponds to the fiber diameter size.

4. Slide the black stop marker on the stripper to

approximately 1 inch (25 mm). Insert fiber

into the stripper until the end of the fiber

touches the marker. Squeeze the stripper red

handles pulling the stripper away from the

handpiece in a smooth motion to ensure that

the fiber coating is cleanly removed. Grasp

the fiber just above the handpiece with a firm

grip. (FIGURE 11).

FIGURE 11

5. Use the ceramic scribe to lightly scratch the

end of the fiber. Place the fiber against a flat

surface. Position the edge of the scribe

approximately ¼ inch (0.6 cm) from the end

of the fiber, and make a gentle scratch

perpendicularly across the fiber (FIGURE 12),

scribing (scratching) the surface at a 45

degree angle with the edge of the scribe.

Make sure that the edge of the scribe is

always perpendicular to the fiber during

FIGURE 12

cleave/scribing (FIGURE 13).

6. Hold the end of the fiber above the scribe between fingers and

bend the end of the fiber until the end section breaks off. If the

fiber end is removed properly, the fiber should be flat.

7. Verify the scribe/cleave quality by aiming the fiber at a flat

surface and observe the shape of the spot created by the visible

aiming beam. If the visible spot is a full circle, then the power

output is optimal. If the circle is distorted, repeat only the

cleave/scribing procedure presented in steps 5 and 6 until you

obtain a circular beam.

8. After the fiber is successfully cleaved, pull the fiber back

through the handpiece, adjust the fiber end to desired length.

Tighten the handpiece base. Ensure that the fiber is secure by

pulling lightly on the fiber optic cable at the proximal end.

FIGURE 13

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OIMv5 10-10 r4

OPERATION INSTRUCTIONS

Turn ON Picasso

•

•

•

•

•

•

Verify Red Emergency button (FIGURE 3, [2]) is depressed.

Turn circuit breaker to ON position. See set-up page 9 for

Circuit Breaker Location.

Rotate key clockwise to ON position. The unit will turn on

and begin a self-diagnostic routine for 4-5 seconds (FIGURE

14 – Picasso only).

Select PRESET

Press STAND-BY to place unit in READY Mode.

Press foot control switch to fire laser and release to stop.

Turn OFF Picasso

•

•

•

•

Press the STANDBY button.

Place handpiece back on handpiece holder.

Switch circuit breaker to OFF position.

Turn off and remove key from the unit, and place in a secure area.

FIGURE 14

CAUTION: Verify that fiber optic assembly is not twisted when returning the handpiece to the holder.

Fiber may break if it is twisted.

Warm-up mode

If, during the self-diagnostic routine, the diode laser temperature is below 64°F (18°C) the system

will go into warm-up mode. Follow the instructions on the display (Picasso only).

1. Press the READY button.

2. Press and hold the footswitch.

3. The LASER FIRING light will flash and a beep will sound until the system is sufficiently

warmed up. This may take up to two minutes. The handpiece should be left in the holder

with the fiber pointing down.

4. Hold the footswitch until the warm-up sequence stops.

NOTE: While output power is negligible, always wear protective glasses during the warm-up. The

warm-up mode will not function at temperatures below 41°F (5°C), (Thermistor Error). Do not leave

the system in an uncontrolled environment where the temperature might drop below 41°F (5°C)

(i.e., the trunk of a car). If this happens, the system should be left to warm up to room temperature

for ten to fifteen minutes before the warm-up mode is activated.

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AMD LASERS®, LLC. Operating Instructions Manual

Picasso | Picasso Lite SPECIFICATIONS

General – Picasso | Picasso Lite

•

•

Dimensions

Weight

L x W x H -> 9.5'' x 6'' x 6.2'' (240 x 150 x 160mm)

2.0 lbs (1 kg)

Electrical – Picasso | Picasso Lite

•

•

•

•

•

•

•

Operating Voltage

Current Rating

Frequency

External Fuses

Main Control

On/Off Controls

Remote Interruption

AC 110/230V ± 10%

3A 1.5A

47-63Hz

None

Circuit Breaker

Keyswitch, Circuit Breaker, Emergency Stop

Remote Interlock Connector.

Laser - Picasso

•

•

•

•

•

•

•

•

•

•

Laser Classification

IV (4)

Medium

GaAlAs

Wavelength

810 ± 10 nm

Power Accuracy

± 20%

Power Modes

Continuous, Repeat Pulse

Pulse Duration

20 ms – 9.9 sec

Pulse Interval

20 ms – 9.9 sec

Delivery Fiber Diameter 200 - 1000µm

Mode

Multimode

Max Output

Power Range

7 Watts output 600µm or 400µm fiber ± 20%

Laser - Picasso Lite

•

•

•

•

•

•

•

•

•

•

Laser Classification

IV (4)

Medium

GaAlAs

Wavelength

810 ± 10 nm

Power Accuracy

± 20%

Power Modes

Continuous, Repeat Pulse

Pulse Duration

30 ms

Pulse Interval

30 ms

Delivery Fiber Diameter 200 µm

Mode

Multimode

Max Output

Power Range

2.5 Watts output 200µm fiber ± 20%

Other Light Sources – Picasso | Picasso Lite

•

Aiming Beam

Diode Laser, max 5 mW, 630-670nm ± 20%

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OIMv5 10-10 r4

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

Contraindications

All clinical procedures performed with Picasso | Picasso Lite must be subjected to the same clinical

judgment and care as traditional techniques. Patient risk must always be considered and fully

understood before clinical treatment. The clinician must completely understand the patient’s

medical history prior to treatment. Exercise caution for general medical conditions that might

contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics,

heart disease, lung disease, bleeding disorders, sleep apnea, or an immune system deficiency.

Medical clearance from a patient’s physician is advisable before treatment.

Warnings

Eyewear

The doctor, patient, assistant, and any other persons in the operatory must wear appropriate laser

eyewear protection for the diode laser wavelength of 810 ± 10 nm OD 5+.

Anesthesia

In soft tissue cases, anesthesia may not be required. Patients should be closely monitored for signs of

pain or discomfort. If such signs are present, adjust settings, apply anesthesia, or cease treatment, if

required.

Adjacent Structures

Picasso | Picasso Lite is designed to remove soft tissue. Therefore, always be aware of adjacent

structures and substructures during procedures. Be extremely careful not to inadvertently penetrate

or ablate underlying or adjacent tissues. Do not direct laser energy toward hard tissues, such as tooth

or bone. Directing laser toward amalgam, gold, metallic surfaces or reflective surfaces can result in

the laser beam reflecting.

Suction

Use high-speed suction as required to maintain a clear field of vision during treatment and/or during

the treatment of herpetic lesions. Do not use Picasso | Picasso Lite if you cannot clearly see the

treatment site. Mask with proper filtration should be utilized for the treatment of herpetic lesions.

Training

Only licensed professionals who are Certified in Class 4 laser use and have read and understood this

Operating Instructions Manual should use this device. AMD LASERS®, LLC assumes no responsibility

for parameters, techniques, methods, or results. Physicians must use their own clinical judgment and

professionalism in determining all aspects of treatment, technique, proper power settings, interval,

duration, etc.

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AMD LASERS®, LLC. Operating Instructions Manual

CLINICAL APPLICATIONS

Introduction

To efficiently remove tissue, it is imperative to understand the nature of the Picasso | Picasso Lite.

Picasso| Picasso Lite operates unlike traditional devices. The techniques mentioned below must be

practiced and perfected to ensure efficient operation. Please study this section carefully, practice on

sample tissues, and attend a quality diode laser-training seminar before using this device in a clinical

situation.

Indications of Use:

Use of Picasso | Picasso Lite is generally indicated for incision, excision, vaporization, ablation and

coagulation of oral soft tissues including the following:

o

o

o

o

o

o

o

o

o

o

o

o

o

o

o

o

o

o

o

o

Gingival troughing for crown impressions

Gingivectomy

Gingivoplasty

Gingival incision and excision

Hemostasis and coagulation

Excisional and incisional biopsies

Exposure of unerupted teeth

Fibroma removal

Frenectomy and frenotomy

Implant recovery

Incision and drainage of abscess

Leukoplakia

Operculectomy

Oral papillectomies

Pulpotomy

Pulpotomy as an adjunct to root canal therapy

Reduction of gingival hypertrophy

Soft tissue crown lengthening

Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa

Vestibuloplasty

Laser periodontal procedures, including:

o Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal

pocket to improve clinical indices including: gingival index, gingival bleeding index,

probe depth, attachment loss and tooth mobility.)

o Laser soft tissue curettage

o Laser removal of diseased, infected, inflamed, and necrosed soft tissue within the

periodontal pocket

o Removal of highly inflamed edematous tissue affected by bacteria penetration of the

pocket lining and junctional epithelium

Tooth whitening Indications:

o Laser assisted whitening/bleaching of teeth

o Light activation for bleaching materials for teeth whitening

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Page 21

OIMv5 10-10 r4

MAINTENANCE

Annual Maintenance

Picasso | Picasso Lite should be serviced annually by a qualified, trai

trained,

ned, and certified technician.

Please contact your authorized

ized representative or AMD LASERS®, LLC to discuss extended service

contracts and annual

nnual maintenance options.

Daily Maintenance

Use a disinfectant to wipe down the front panel of Picasso | Picasso Lite system after each

procedure. Do not use bleach or abrasive cleansers.

Contamination Control Procedures

The contamination

n control suggested for fiber optic cable, handpiece,

ndpiece, and interchangeable tips

tip is the

system sterilization method. However, before sterilization, Picasso | Picasso Lite reusable accessories

(handpiece, fiber optic cable, and interchangeable tips) should be carefully cleaned per the following

procedure.

NOTE: Fiber optic cable is not autoclavable unless labeled “autoclavable

“autoclavable.”

Cleaning Instructions for Picasso | Picasso Lite Strippable Fiber Handpiece and

the Fiber Optic Cable

FIGURE 15

The cleaning process is intended to remove blood, protein

protein, and other potential contaminants from

the surface and crevices of reusable accessories. This process will also reduce the quantity of

particles, microorganisms, and pyrogens present. Cleaning should be performed

d prior to sterilization

and must be conducted only by qualified office personnel trained to perform the procedure and

handle the Picasso | Picasso Lite Fiber Optic Delivery System.

Wear protective latex gloves when handling the contaminated delivery system. To disconnect the

delivery system, follow the instruction for delivery system assembly pres

presented

ented in the "Delivery

"

System" section.

High-level

level Disinfection Instructions for the Fiber Optic Cable

•

•

•

•

•

- 21 -

Transport the delivery system to a decontamination/st

decontamination/sterilization work area.

Take

ake the fiber and strip 1 inch (25mm) off of the distal end of the fiber using the

th fiber

cleaver. Make sure the part that has debris is removed entirely. Dispose of the contaminated

fiber tip accordingly.

Prepare a sterilizing

erilizing and disinfecting solution of CAVICIDE and submerge approximately 12

inches (30cm) of the fiber’

fiber’s distal end into the solution for 5 minutes. For high level of

disinfecting, immerse the fiber end for 30 minutes at 68°F (20°C).

After this process is completed, thoroughly rinse and dry the fiber.

For disposal of CAVICIDE

IDE disinfecting solution

solution,, please follow the manufacturer’s

manufacture instructions.

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AMD LASERS®, LLC. Operating Instructions Manual

Steam Sterilization for Picasso | Picasso Lite Surgical Handpiece

Before sterilization, the handpiece must be cleaned and disassembled. For cleaning, follow the

procedures previously described. To disassemble the handpiece from the fiber optic cable, carefully

loosen the handpiece base and slide handpiece off of the fiber optic cable.

The process of thermal sterilization with saturated steam under pressure is carried out in an

autoclave. To perform this procedure, follow these step-by-step instructions:

• Place the handpiece and interchangeable tips inside a single wrap self-seal autoclave pouch.

• Remove autoclave tray and place pouch(s) on the tray.

• Place tray inside the autoclave chamber and set controls to the following values:

Temperature:

250°F (121°C)

Pressure:

15 PSI (1 Bar)

Time Cycle:

20 minutes

• At the completion of the autoclave cycle, remove the tray and let the handpiece cool and

dry.

• Attach the handpiece and the fiber optic cable to the unit for the next procedure.

CAUTION:

DO NOT place or stack other devices on top of the fiber optic cable.

Transportation

Picasso | Picasso Lite lasers are susceptible to misalignment if not handled properly. The unit should

ALWAYS be handled carefully and never banged, jarred, jolted, dropped, or hit.

Do not transport the unit unless it is completely packaged inside of its shipping box. If you have any

questions regarding transportation, please call your authorized representative or AMD LASERS®, LLC.

Storage

Picasso | Picasso Lite should be stored in a cool, dry place when not in use. Cover the unit when not

in use for extended periods of time. Store the system in a place where it will not be accidentally hit.

Picasso | Picasso Lite are shipped inside a custom shipping box. Please save and store the box in a

cool, dry place.

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Page 23

OIMv5 10-10 r4

CALIBRATION

Picasso | Picasso Lite comes factory calibrated and certified for use. For accurate treatment

results, the unit(s) should be calibrated every 12 months following the date of manufacture. Due

to the potential for electrical shock, personal injury, or death; calibration should only be

performed by authorized personnel. Improper calibration could lead to damage and failure to

calibrate the laser. Calibration by anyone other than a certified AMD LASERS technician will

void the warranty.

To schedule calibration of your unit, contact your authorized representative or AMD LASERS®,

LLC at (866) 999-2635 or +1 (317) 202-9530 to obtain an RMA. Calibration generally takes 5

business days (excluding holidays). Calibration of AMD LASERS units is performed with an

output watt meter and AMD LASERS calibration software.

EQUIPMENT NEEDED

1. PC with Windows XP or better and a serial (RS-232) port

2. Laser power/energy head unit such as an Ophir Model II P/N 7Z01550 or equivalent

3. Power/energy meter for low power lasers with 810 nm wavelength capability and accuracy better

than +/- 3%, such as an Ophir power meter P/N 7z02637 or equivalent

4. AMD LASERS Calibration Software

5. AMD LASERS Calibration Data Cable

6. #1 Philips Head Screw Driver.

Picasso

TURN LASER OFF and UNPLUG PRIOR TO CALBRATION PROCEDURE.

Remove front and side panel

1: Set up software, and connect laser to computer. Reconnect front and side panel.

2: Turn laser “on” and fire the laser with the fiber tip approximately 1-2 mm from the power meter

laser head.

3: Adjust the values in the appropriate fields to increase or decrease the output wattage to within +/20% of the desired setting.

4: When appropriate output power is reached, select “save”, and proceed to the next setting.

5: Repeat steps 2-4 above until all fields have been properly adjusted.

Picasso Lite

TURN LASER OFF AND UNPLUG PRIOR TO TESTING

Remove front panel

1: Move and place the short circuit test ring onto the test pin to enter calibration mode. Reconnect

the front panel.

2: Turn laser “on” and fire the laser with the tip approx 1-2mm from the surface of the power meter

laser head.

3: Adjust the output values to within +/- 20% of the desired setting by using the “light” button to

increase and the “sound” button to decrease.

4: Data is saved automatically after adjustment.

5: Remove the short circuit test ring from the test pin when calibration is complete.

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Page 24

AMD LASERS®, LLC. Operating Instructions Manual

Calibration schedule

Dates:

Authorized by:

Purchase Date _____//______//__________

Calibration 1 _____//______//___________

(12 months after purchase date)

_____________

Calibration 2 _____//______//___________

(24 months after purchase date)

_____________

Calibration 3 _____//______//___________

(36 months after purchase date)

_____________

Calibration 4 _____//______//___________

(48 months after purchase date)

_____________

Calibration 5 _____//______//___________

(60 months after purchase date)

_____________

Calibration 6 _____//______//___________

(72 months after purchase date)

_____________

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Page 25

OIMv5 10-10 r4

APPENDIX A – LABELS & DESCRIPTIONS

FIGURE 16

5

6

1

2

3

4

7

8

10

9

13

11

12

15

14

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Page 26

AMD LASERS®, LLC. Operating Instructions Manual

Label Positions

Label descriptions

1. Warning for Laser Aperture Port

Black on Yellow triangle shaped – located on back of unit next to the laser output port

2. Emergency Laser Stop

Black on Yellow – located on the front of unit surrounding the emergency off red button

3. Laser Off – 0, Laser On – I

Black on Yellow – located on the front of the unit surrounding the key switch

4. Laser Aperture label

Black on Yellow– located on back of unit next to the laser output port

5. Foot Switch

Black on White – located on the back of the unit next to the foot switch port and on the

wireless foot switch next to the foot switch port

6. Remote Control

7. CDRH Compliance label

Black on White – located on top of the unit

8, 11. Manufacturer label

Black on White – located on the top of the unit

9, 12. IEC, Exploratory label

Black on yellow – located on the top of the unit

10, 13. Laser Danger label

Red and black on white – located on the bottom of the unit

14. Fragile Keep Dry

Located on both ends of the shipping box

15. Quality Control Acceptance label

Black on White – located on the bottom of the unit

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