Pilot Laser Operator's Manual

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PILOT User Manual Contents

Section 1 Introduction 4

Section 2 Specifcations 5

Laser Specifcations 2. 5Delivery System Specifcations 2.1 6

Warranty 2.2 6Parts List 2.3 6

Section 3 Laser Assembly & Setup 6

Instructions on Unpacking & Dealer Assistance 3. 6Shipping Container Inormation 3..1 6Contents o Shipping Container 3..2 6Power Cord Installation 3..3 7Power Fan Switch 3..4 7Laser Key Switch 3..5 7Wireless Receiver Installation 3..6 7Remote Interlock 3..7 7Foot Pedal Battery Installation Instructions 3..8 8Emergency Shutdown Switch 3..9 9

Installing the Disposable Fiber Cassette 3..1 9Summary 3..11 9Visual Assembly Aides 3..12 1-13

Facility and Environmental Considerations 3.1 14Power Requirements 3.1.1 14Heating and Ventilation 3.1.2 14Lighting 3.1.3 14Combustible Chemical Gases 3.1.4 14Vacuum and Filtration 3.1.5 14Access and Visual 3.1.6 14Channel Programming 3.1.7 14-15Laser Frequency 3.1.8 16

Section 4 Saety Considerations 16

Food and Drug Administration 4. 16Wireless echnology 4.1 16Statutory Licensure 4.2 17OSHA Provisions 4.3 17Laser Saety Program 4.4 17Continuing Education 4.5 17In-O ce Saety Issues 4.6 18Lighting 4.6.1 18Saety Eyewear 4.6.2 18est Firing 4.6.3 18Power Changes with Fiber Changes 4.6.4 18Fiber Preparation 4.6.5 18Laser Signage 4.6.6 18Sharps Disposal and Sponge Disposal 4.6.7 18

Plume Evacuation 4.6.8 18Key Switch and Mode Selection 4.6.9 18Saety Education 4.6.1 18Laser Security 4.6.11 18Emergency Shutdown Options 4.6.12 19Hard issue Procedures 4.6.13 19

ANSI Standards 4.7 19


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Section 5 Operating the Laser 19

Standby and Ready Status 5. 19Continuous Wave (CW) Mode 5.1 19Pulsed Energy Mode 5.2 2issue Response to Laser Energy 5.3 2Fiber and Handpiece Care 5.4 2Warning Do Not Autoclave 5.5 2

System Procedures 5.6 21reatment Area Requirements 5.6.1 21Foot pedal 5.6.2 21Fiber Cassette 5.6.3 21Fiber Preparation 5.6.4 21Emergency Shutdown Button 5.6.5 21Key Switch 5.6.6 21Setting Parameters 5.6.7 21Power Selection 5.6.8 21Selecting Programs 5.6.9 21Aiming Beam 5.6.1 22Examine the Fiber ip 5.6.11 22Depress Te Ready Button 5.6.12 22est Fire Te Laser 5.6.13 22

Depress Te Foot Pedal 5.6.14 22Remove Your Foot 5.6.15 22Place Laser In Standby Mode 5.6.16 22Cleave Used Fiber ip 5.6.17 ` 22Sel Diagnostic and Monitoring 5.6.18 22

Section 6 System Components: Preparation, Care and Maintenance 23

Disposable Fiber Cassette 6. 23Replacing the Fiber Cassette 6..1 23

Fiber Preparation 6.1 23Jacket 6.1.1 23Cladding 6.1.2 23Quartz / Silica Fiber 6.1.3

23

Stripping the Fiber 6.1.4 24Cleaving the Fiber 6.1.5 24Initiating the Fiber 6.1.6 25Fiber Disinection 6.1.7 25

Laser Maintenance 6.2 25Chassis Disinection 6.2.1 25Calibration 6.2.2 25

Handpiece Preparation 6.3 26Autoclavable 6.3.1 26Handpiece Components 6.3.2 26Rocker Switch 6.3.3 26Disposable ips 6.3.4 26Prepare the Fiber 6.3.5 26Mounting the ip 6.3.6 27

Section 7 Labels, Signs, Warnings and Manuacturers Inormation 27

Federal Compliance 7.1 27

Danger, Warnings and Caution 7.2 7.13 27-29

Nominal Ocular Hazard Distance 7.11 28

Statements Regarding Electromagnetic Compatibility 7.14 29

Section 8 Servicing 29

Warranty Policy 8. 29

Repairs and Returns 8..1 29

FDA and Laser Standards 8.1 29-3


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SECTION 1 INTRODUCTION

CAO Group, Inc. has developed the PILO, the most practical and least invasive technology available or perorming so tissue surgical procedu

PILO reduces wound healing time[1] and lets you perorm procedures in a conservative, less traumatic manner. Te lasers energy is delivered thro

a 4 micron silica flament, giving you control over the depth and width o areas being excised while providing simultaneous hemostasis. Weighing

pounds, the PILO is controlled by a wireless oot switch that oers maximum exibility in unit positioning.

FEATURES

Wireless Foot Switch, maximum exibility in placement

4 Micron Fiber ip, precise target area

Easy to operate intuitive program

Lightweight, easy to move, 5.5 pounds

Small size, easy to position 5.5 X 6.25 X 8.75

Retractable fber delivery system gives you reedom to position yoursel

81nm wavelength or so tissue surgery, reduces healing time[1]

Aiming beam 63nm wavelength provides illumination to working site

Adjustable power .1 to 9. Watts allows extraodrinary exibility in procedures and uses

Balanced ergonomic pen like fber optic delivery

Te major components o the PILO are semiconductor chips that are commonly reerred to as AIGaAs. Tey are activated or pumped by pass

an electrical current through the diode to produce an elliptical shaped display o monochromatic light that can be ocused into a very small point

placed into the delivery fber. PILO generates energy in two wavelengths, 81nm and 63nm. Te energy produced at 81nm is used as a so ti

surgical laser; it is invisible non-ionizing radiation that does not create changes in cellular DNA. Te energy produced at 63nm illuminates the site

SAFETY

Laser saety is o paramount importance and each o ce should quickly develop and implement a laser saety program and identiy a Laser Sa

O cer (LSO) to be responsible or the laser. Te LSOs duties include management o the laser and all accessories as well as training o ce person

in all aspects o laser saety.

ALWAYS test fre the laser away rom tissue beore using it on a patient. Te doctor, sta, patient and anyone present in the operatory should be wearthe appropriate saety eyewear whenever the laser is being operated. Strict adherence to protocols or sae laser use is essential.

Footnote [1]: WOUNDS: A Compendium of Clinical Research and Practice:Volume 16, Number 12:December 2004:Papillion etal


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SECTION 2 SPECIFICATIONS

2.0 Laser Specifcations

Weight 5.5 lbs

Dimensions in Inches (H x W x L) 5.5 x 6.25 x 8.75

Laser Classifcation: (Per IEC 6825)Laser Diode Class 4 Laser Device

Wavelength:Laser 81nm 2nmAiming Beam 63nm 66nm 15nm

Beam Divergence 13 degrees 1 degree

Power Range 1 mW to 9 Watts

Hertz Rate in Pulsed Mode - Fixed 1. Hz

Pulse Duration - Fixed .5 seconds

Duty Cycle

Pulsed Mode 5%Continuous Wave 1%

Aiming Beam (3 mW) Yes

Audible Notifcation Yes

Visual Notifcation Yes

Power Requirements 11 12 VAC @ 6 Hertz22 24 VAC @ 5 Hertz

Amperage 1.5 Amps @ 11 115 VAC.75 Amps @ 21 -23 VAC

Cordless Foot Pedal:Frequency 2.4 GHz

Battery 9 volt Lithium

Operating emp 20C - 30C (680F - 860F)

Storage emp -20C - +40C (-50F - +150F)


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2.1 Delivery System Specifcations

2.1.1 Quartz Silica Fiber

1 Cassette - Approximately 2 (6 meters) o Silica fber

Fiber Diameter 4 microns

Autoclavable No

2.2.2 Handpiece

Autoclavable 2

2.2.3 Tips or Handpiece

Disposable 2 per box

2.2 Warranty

Laser 1 year parts and labor

Fiber and Cassette 9 days parts and labor

SECTION 3 LASER ASSEMBLY & SETUP

3.0 Instructions on Unpacking & Dealer Assistance

Do not attempt to unpack the laser and install the various components without reading the manual frst. I you are unsure about

any aspect o the assembly, call your authorized dealer.

3.0.1 Shipping Container Inormation

Please keep the shipping box. I you need to return the laser, repack it in the original box.

3.0.2 Contents o Shipping Container

1) (2-148) PILO Unit with 4 Micron Fiber Cartridge System containing 2 o 4-micron fber

1) (2-28) Fiber Stripper ool

1) (2-27) Fiber Cleaving ool1) (2-14) Protective Glasses Solid side Style

1) (2-141) Protective Glasses Plain Style

2) (2-145) Package (2) Handpiece ips straight

1) (2-146) Package (2) Handpiece ips 6

2) (2-25) Handpiece autoclavable

1) (2-3) Laser Key

1) (2-149) Wireless Foot Pedal

1) (2-56) Wireless Receiver

1) (1156) 9 Volt Battery

1) (2-81) Power Cord, Hospital Grade, 8 long

1) (2-19) PILO Hexdriver

1) (2-147) PILO Owners Manual1) (2-15) Laser Saety Sign


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3.0.3 Power Cord Installation (see Figure 3.0 on page 10)

Remove the power cord rom the PILO package.

Plug the power cord into the appropriate receptacle on the back o the laser.

o prevent power surges due to electrical storms or spikes in line voltage, use a power strip with a circuit breaker or

unplug the laser when you are not present.

Plug the power cord into a 11 Volt AC outlet rated at 6Hz.

3.0.4 Power/Fan Switch (see Figure 3.0 on page 10)

Te power/an switch or the laser and an is the frst item you turn on.

Te switch is located on the rear panel o the laser near the lower le hand corner.

3.0.5 Laser Key Switch (see Figure 3.1 and 3.1a on page 10)

Te laser key switch is the main saety switch or your laser.

Place the laser key into the key receptacle located near the lower right corner on the ront o the laser.

Check the key switch by turning the key clockwise approximately 1/4 o a turn. Tis is the (ON) operating position or the

key.

Te an will start when the power/an switch is on and the key is turned.

Prior to leaving the o ce check to see that the key switch has been turned o and the key removed and stored in a sae

place.

3.0.6 Wireless Receiver Installation (Figure 3.0 on page 10, Figure 3.3 and Figure 3.4 on page 11)

Locate the wireless transmitter receptacle on the back o the laser.

Insert the wireless transmitter adapter into the marked receptacle on the back o the laser.

Make sure it is securely locked.

Install the enclosed 9 volt Lithium battery in the ootswitch.

Te ootswitch is now ready or operation.

An extra 9 volt Lithium battery should be kept in your o ce inventory as the battery should be replaced every 1 hours

o continued operation.

3.0.7 Remote InterlockTe PILO is equipped with a Remote Interlock Jack. Te Remote Interlock Jack is provided so that a clinician may install the la

in a dedicated laser treatment room such that the laser will be interlocked with the entrance door o the room. In such an interlock

installation, the laser would shut o anytime the door is opened to protect the eyes o the person who is entering the room. It is recogni

that this method o installment is not acilitated or practical in many operatories or clinics. Te Remote Interlock Jack is available to

practitioner that requires it. Te Remote Interlock Jack is located and clearly labeled on the rear o the laser. Te mini phono jack is wi

in the normally closed position; meaning that no urther action is required to operate the laser without the interlock loop. I the interl

loop is desired you may purchase the loop rom a local electronics store. You need only inorm the local electronics store that you requ

a mini (1/8) mono-phono jack wired into a normally closed momentary switch and select the switch design that best suits your needs

install the loop, install the switch on the door and simply plug the mini phono jack into the Remote Interlock Jack on the rear o the la


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Figure 1 Figure 6

Figure 2 Figure 7

Figure 3 Figure 8

Figure 4 Figure 9

Figure 5

1. Make sure the laser iscompletely turned o beore

placing the battery in the ootpedal.

6. Locate the battery terminalinside the well. Do not pull

excessively on the wires.(Figure 5)

2. Place the pedal ace down ona hard, clean surace. (Figure 1)

7. Remove the battery romits packaging and attach the

battery to the terminal.(Figure 6)

3. Remove the hexdriver romits holder on the underside othe pedal. (Figure 2)

8. Place the battery in the wellwith the connector to the sameside as the wire leads emergerom the housing.(Figure 7)

4. Insert the hexdriver intothe screw holding down thebattery cover. Rotate the keycounterclockwise until thescrew comes out completely.Repeat or the other screwholding down the batterycover. (Figure 3)

9. Replace the battery cover.

1. Replace the screws. urnthe hexdriver key clockwise totighten the screws. Te screwsare su ciently secure oncethey no longer turn with gentleorce. Do not over tighten.(Figure 8)

5. Push down on one endo the battery cover whilesimultaneously liing up onthe other end to remove thebattery cover. (Figure 4)

11. Replace the hexdriver backin its holder. (Figure 9)

3.0.8 Foot Pedal Battery Installation InstructionsTe 9V battery and battery cover will need to be installed beore the PILO will unction.

NOTE: It is recommended to use a 9 volt Lithium battery to pothe cordless oot pedal. Tis type o battery has been tested to

or over 1 hours o oot pedal operation. When the battery vage begins to drop, the oot pedal will begin to beep, signaling you have approximately 2 hours o operating time le beorebattery lie is completed.

NOTE: A 9 volt alkaline battery may be used; however the expectancy o an alkaline battery is less than 35 hours o operatime.


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3.0.9 Emergency Shutdown Switch (see Figure 3.5 and 3.6 on page 12)I the shutdown switch is locked down, the laser will not turn on. Beore you can activate the laser, you must frst check to see i the emergency shutdswitch has been depressed prior to shipment and locked in the o position.

Te switch is the red button located on the top o the laser. Release the switch by grasping it between your thumb and index fnger, and gently depress it as you turn the button 1/4 turn clockwise. You will eel it click or release and the spring loaded button will pop back up

Te display on the control panel should now be lighted. I the cartridge lock plate is not ully engaged, it will prevent the display rom lighting up. I you fnd the display is still not operational, check all attachments, keys and switches to see that they are securely installed and thatyou have an active wall plug or electricity.

I the laser can not be activated, please contact the manuacturer. (See page 31 or contact inormation.)

3.0.10 Installing The Disposable Fiber CassetteTe unit comes with a disposable fber cassette installed with 2 o fber. Te fber cartridge may be removed and replaced when the optical fberbeen consumed. Tere is a oot o white heat-shrink at the end o the fber spool. At this point, a new fber cassette should be ordered.

NOTE: Retain the cartridge lock, do not discard.o install a new cassette, careully remove the new fber cassette rom the packing. Make sure the laser is switched o and the power cord has been unplugged. Remove the cartridge lock by pressing on the tab and sliding the lock plate to the side.

While grasping the fber connector, press in and rotate counter clockwise. Ten pull the connector straight back. Pull the cartridge straight up, out o the bay. Using a completely dry air spray or canned air, li down the black ap and blow air into the connector receptacle in the side o the housing. Tis

will remove any dust particles that may be present. CAUTION: Do not tip the compressed air can; this will result in condensation deposit onthe fber errule.

Slide the new cartridge down into the bay and press it frmly in place. Remove the plastic cap rom the end o the connector. Avoid placing your fnger on the proximal end o the new fber. While opening the door on the laser aperture with one hand, insert the proximal end o the new fber into the laser aperture. (Figure 3.13) Be careul to align the slot on the fber end with locking hub aperture. (Figure 3.14). Once inserted turn the fber locking hub to the right (clockwise) to lock the fber securely into the S connection. Once the fber is connected, align the dove tail o the cassette with the dove tail receiver on the chassis wall. (Figure 3.8) Tis will help assure

the power coupler (a serial port) on the underside o the fber cassette will be aligned with the receiver on the laser chassis. Slowly press the cassette into place (Figure 3.8 and 3.9 and 3.11). Once connected, replace the end cap to secure the fber cassette. Te laser will not operate until the end cap is frmly latched in place.

urn the key switch and power/an switch to the on position. est your power connection by advancing the fber, using the rocker switch on the top o the cassette. Depress the switch at its most anteriorpoint to see i it moves the fber orward.

Select a low power to check transmission o energy ( 1. Watt 1.5 Watt). Put on saety eyewear. Place laser in Ready mode. Depress the oot pedal to activate the laser while holding the fber approximately 2-4 mm away rom a piece o paper with printing on it. Aim at the printing, the paper will begin to burn in 1-2 seconds. You should be able to see the aiming beam on the paper and the fber tip should produce enough heat to let you know it is installed properlyand the fber is sound.

You do not want to use an initiated fber or this check because the energy would stop at the tip.

3.0.11 Summary: Laser Assembly Instructions1. Attach the lasers power cord and place the plug into the wall receptacle.

2. Attach the oot pedal wireless receiver.3. Install the oot pedal battery.4. Attach remote interlock, i desired.5. Check the emergency shutdown switch to see that is has been released.6. Install the fber cassette and attach the fber to the S connector and lock the locking hub.7. Place the key into the key switch receptacle (Figure 3.1a) and turn the key to the right. Te console should light up.8. Te light on the console indicating the operating status should be in the standby mode.

NOTE: When the power cord is plugged in, the an/power motor switched on, the wireless oot pedal receiver attached and the emergency shutdoreleased, the key will turn the laser on.


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3.0.12 Visual Assembly Aides

Emergency

Shutdown

Disposable

Fiber Cassette

Remote

Interlock

Connector

Wireless Foot Reciever

Input Port

Manuacturers

Specifcations,

Regulatory and

General Inormation

Fiber Cassette

End Cap Release

Fuse Receptacle

Power Cord Receptacle

Power/Fan SwitchPILO Digital Dispaly

urn the key 1/4 o a turn to

the right to turn on the laser

Handpiece

Holder

Key Switch

Control Panel

Fiber Aperture

Label required by

Saety Standards

Fiber Extend and

Retraction Switch

Label required by

Saety Standards

LED Screen

Figure 3.0

Figure 3.1

Figure 3.1a


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Figure 3.2 - Control Pad Settings Figure 3.2a - Display Indicators

Aiming Beam SWorking Beam Power Setting

Laser On Indicator

Ready Indicator

Continuous Mode

Pulse Mode

Manual Setting Program Setting Indicator

Figure 3.4 - Wireless Foot SwitchFigure 3.3 - Wireless Foot Switch Reciever Port

Side ViewFront View

Align the lip on the proximal end o the wireless receiver with

the notch at the top o the input port.

Mode: Press this key to select Continuous or Pulse mode.

Aiming Beam: Use these to adjust the aiming beam power.

Program:Press this key to select either manual (M) or one o three

user defned programs (P1, P2, P3). Each program will save the

parameters working beam, aiming beam and mode o operation.

Te settings can be changed as desired or any o the program

modes. o set the user defned program modes, choose P1, P2 or

P3, set your preerred settings and push the ready button. Upon

activating the ready button, the new settings will be retained.

Increase and Decrease: Use these to adjust the power setting

rom to 9 watts. Hold the desired key to rapidly change the value.

Laser On: Tis illuminates when the oot pedal is depressed,

indicates that the working beam (81 nm) energy is being emit

Ready Indicator: Tis illuminates when the READY key

pressed. It will blink or 3 seconds, and then remain steady. O

it stops blinking, the aiming beam will be activated.

Continuous and Pulse Mode: Tis illuminates when the un

in continuous mode. Use the MODE key to toggle back and o

between Continuous and Pulse.

Working Beam Setting: Indicates the working beam po

output setting.

Adjustable Aiming Beam: Te PILO is actually two laser

one, the inrared 81 nanometers wavelength laser which peror

the actual treatment o the so tissue and the 63 nanome

laser pointer which illuminates the direction where the laser be used. Each bar represents 2% o maximum intensity. Tu

bars means the aiming beam is shut o.

Program Setting Indicator: Shows the current program m

that is selected. Pressing the PROGRAM button will cycle throu

the programs le to right, then back to manual M.


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1. Depress the red button on the top o the system to shutdown (eel the click), the

unit is OFF in the down position Emergency Shutdown Switch.

2. Depress slightly and turn right o a turn to release. Te emergency stop will

pop up and the LED screen will light.

Check The Emergency Shutdown System

Figure 3.6 ReleaseFigure 3.5 Shutdown

Figure 3.8 Laser Aperture (S adapter) and power receiver or the power coupling device on the

base o the cassette.

Figure 3.7 op Figure 3.7a Rocker Switch Activation

Laser Aperturewith S Connection:

Te proximal end o thefber inserts here and islocked by turning thelocking hub to the right

Depress the RERAC or EXEND

rocker

Receiver or the Fiber

Cassette end caplocking device

Fiber extend and retract rocker switch(See Below)

RETRACT EXTEND

Receiver or thePower CouplingDevice

Dove tailAlignment Guide


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Figure 3.9 Base o the Fiber Cassette and the 15 Pin Power

Coupling Device.

Figure 3.11 Disposable Fiber Cassette without the End Cap.

Figure 3.13 Locking Hub Figure 3.14 Alignment Slot - Frontal View

Figure 3.12 Fiber exit rom the Disposable Fiber Cassette.

Figure 3.1 Removable End Cap o the Fiber Cassette.

Proximal End

Depress at the baseo the arrow torelease the cover orthe fber cassette

15 pin PowerCoupling Device

Alignment Slot

Te proximal end o the fber extends rom the internal wall o thfber casette and must be attached to the laser by inserting it intoLaser Aperture (S adapter).

Once it is inserted into place, it is locked by turning the locking hubapproximately 1/8 turn to the right.


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3.1 Evaluating The Facility and Environmental Considerations (United States)

In order to insure the sae use o the laser in your acility, please check to make sure that the proposed location has the ollowing:

Te room where the laser is used should have good cooling and heating system so that the laser can be operated within

optimum range o 2 - 3C (68 - 86F). Avoid storing or transporting the laser in temperatures below -2 Celsius (-5

3.1.2 Heating and Ventilation

- 1 24 VAC1 %

- 3 Amps- Frequency range 45-63 Hz

- 9 volt Lithium battery

3.1.1 Power Requirements

3.1.3 Lighting

Overhead lighting should provide enough illumination to see properly, accessory lighting devices may also be used.

All gases that are combustible or support combustion and are used in the operatroy area where the laser is in use mus

turned o during the procedure. Cleaning supplies or other ammable chemical compounds should be stored in an a

away rom the surgical site in order to avoid possible combustion.

3.1.4 Combustible Chemical and Gases

3.1.5 Vacuum And Filtration

Plume evacuation is a priority when vaporizing tissues, use o a high volume vacuum system and high fltration masks t

are suitable or virus and bacterial control should be used at all times.

3.1.6 Access and VisualAccess to the treatment area should allow the team to restrict entry while the laser is in use. Tere should be a Laser In

Saety Sign placed in a designated area adjacent to the entry into the treatment area. (See Figure 7.1)

Tere is no concern i 2 or more PILO lasers in the same o ce are set to the same channel. Each laser and its correspond

pedal have additional programming that is unique to the pair. Te pedal rom one laser will not activate any other la

However, i units on the same channel are near each other, the transmissions rom one may interere with the signal r

another and thus prevent the second laser system rom operating properly. It may become necessary to change the chann

on one or more units to minimize intererence.

3.1.7 Channel Programming Procedure


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Step 1 Step 2

Step 3 Step 3 (continued)

Step 4 Step 5

Step 6

1. Make sure the unit is o beore going orward with

the programming procedure. Do not press the oot

pedal or at least 3 seconds beore proceeding.

2. Beore turning the unit on. Press and hold PROGRAM.

3. While holding the program key down, turn on the

unit, the display will briey show =P, then show

c1 or channel 1, c2 or channel 2, up to channel 8

(depending on what programmed channel the unit is

already on). Release the PROGRAM key.

4. Press the INCREASE key to scroll up through the

channels, rom 1 to 8. Press the DECREASE button to

scroll rom 8 back to 1 to select the desired channel.

5. Once the desired channel is selected, press PROGRAMagain. Te unit will beep the same number o times as

the channel selected. Aer a ew moments the display

will show - - .

6. With the main unit in this condition - -, press the

pedal. While the pedal is pressed, the display will change

to -I I-. Te pedal is now set to the same channel and

is matched with this laser. When the pedal is released,

the display will return to - -. Tis indicates that the

channel change was successul and the new channel is

saved in the memory.

7. I any problems occur during this process, the display

will show E r. I this occurs, turn the unit o, then on

again. Te original channel should be restored.

8. Once channel programming is complete, turn the

unit back power an switch o, then on again. Te laser

display should return to a laser power setting.

Channel Programming Procedure


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3.1.8 PILOT Diode Laser Frequency:

Te 2.4GHz requency is popular or networks and other wireless devices that share similar technology. Te nature o spread-spectrum modulatio

the 2.4GHz requency means that a multitude o devices can co-exist in the same 2.4GHz spectrum. Since the PILO 2.4GHz wireless receivers h

a much lower power output, it is unlikely that they would interere with higher-power devices. I this were to occur, the higher-power devices wo

quickly switch to another channel to achieve uninterrupted operation.

Te 2.4GHz wireless receiver uses an entirely dierent modulation scheme, and can not de-modulate (receive) data rom Wi-Fi o Bluetooth devices.

converse is also true; their modulation methods are incompatible.

PILO is electronically coded: each pedal and PILO share a UNIQUE SERIAL NUMBER INTERLOCK protocol or reliable operation:

Te PILO pedal communicates with only one PILO diode laser, there is a 2-way electronic code which must be verifed or easy

transmission and acknowledgement. Te pedal and laser unit are interlocked to only each others electronic codes.

I data rom one PILO pedal is ever received, embedded verifcation measures ensure that it is always ignored and discarded.

I data were ever received rom another wireless device with a compatible modulation scheme (2.4GHz requency), it would

immediately be discarded in the same way.

In summary, the wireless receivers in the PILO have less than 2% o the output power o typical Bluetooth or Wi-Fi devices, and thereore can n

mistakenly receive data rom such devices.

SECTION 4 SAFETY CONSIDERATIONS

Te sae use o the PILO is the responsibility o the entire team including the doctor, sta and Laser Saety O cer. Protocols or the sae use o la

have been developed by a combination o medical and dental proessionals working in concert with educators at the university level, scientists and l

manuacturers. Sound judgment and the concern or patient saety should be the basis o all laser care. Te ollowing entities have inuence over l

use.

4.0 Food and Drug Administration

Manuacturers o products subject to perormance standards under the Federal Food, Drug and Cosmetic Act, Chapter V, Subchapter C ElectroProduct Radiation Control are required to certiy compliance with the regulations and urnish various reports to the Center or Devices and Radiolog

Health (CDRH). For medical laser manuacturers, additional review by the FDA o the saety and eectiveness o the device is required. Compan

who intend to market a medical laser today must receive authorization rom the FDA to permit the device into commercial distribution. Tere are

orms o pre-market clearance procedures. Te premarket notifcation (51(k)) procedure is principally used or those devices that are documente

be substantially equivalent to legally market Class I and Class II devices. For new devices not equivalent to legally marketed devices, a more comp

PMA is required.

4.1 Wireless Technology

In order to promote e cient use o the radio spectrum in various global markets, the US FCC (Federal Communications Commission) and o

international government agencies have developed technical standards or devices that are capable o emitting radio requency energy when in use s

as wireless data cards. Tese products need to receive certain identifcation numbers in accordance with the Commission Equipment Authorizat

rules prior to marketing in US markets. Te FCC certifcation is similar to the CE certifcate or the European markets. Te Code o Federal Regulatiitle 47 (47 CFR), Part 15 covers the rules or the operation o unintentional, intentional or incidental radiators. Any electrical or electronic dev

incorporating a digital circuitry and operating with an oscillator or clock speed o grater than 9kHz requires approval to this rule. Tere are various ty

o FCC Part 15 approvals, depending on the nature o the product and its intended use. In Canada, IC RSS 21 (Radio Standards Specifcation)

out the requirements or license exempt low-power international radiators. Tis standard is very closely harmonized in terms o permitted requen

types o operation, and other technical requirements to the FCC requirements, but a separate certifcation application is required or Canada. In

European Community, compliance with several saety directives and testing to EN 3 328, EN 695 and EN 31 489 is required or this type o dev

Te manuacturer is required to provide a Declaration o Conormity as evidence o its compliance with the various regulatory requirements.


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4.2 Statutory Licensure

Check with your state to confrm requirements or licensure and use o the PILO.

4.3 OSHA and its Provisions

Worker saety is the responsibility o the employer and is regulated by OSHA (Occupational Saety and Health Administration), a division o the U

Department o Labor. OSHA has issued no specifc standard or sae use o lasers but recognizes ANSI standard Z136.1 as a source or analyzing sa

with respect to medical lasers. For more inormation see OSHA echnical Manual (ED 1-.15A) Section III, Chapter 6, 1999. CAO Group recomme

implementation o a Laser Saety Program or the saety o you patients and o ce sta in connection with the use o the PILO.

4.4 Laser Saety Program

CAO Group recommends implementation o a Laser Saety Program appropriate or your o ce. Te plan should include the ollowing:

Delegation o authority and responsibility or supervision and control o the laser to a designated Laser Saety O cer.

Minimum raining requirements or users o lasers.

Security preventing unauthorized use o the laser.

Standard operating procedures to regulate the work environment in order to protect the patient and o ce sta rom laser hazards.

Te sae use o a laser is the responsibility o the Laser Saety O cer (LSO). It is their responsibility to train the sta, maintain records concern

training, the lasers perormance, perorm saety checks and prepare the laser or use on a daily basis. Te LSO must keep records o any incidents

relate to the ailure o the laser or any adverse eects related to laser therapy and report such incidents as prescribed by law. Te LSO assures tha

medical ollow-up has been sought or has occurred ollowing any adverse incident during treatment. Te LSO is responsible or the training o all o

personnel who are involved with the laser preparation and use. Daily checks o the acility and equipment are also the LSOs responsibility. Te L

should test fre the laser each day prior to beginning each treatment procedure. For more inormation on the contents o a Laser Saety Plan you

review ANSI Standard Z136.3 or Sae User o Laser in Health Care Facilities or R IEC 6825-8 Guidelines or the Sae Use o Medical Laser Equipm

4.5 Continuing Education

Te Laser Saety O cer should insure that the operator and sta attend laser courses taught by qualifed laser educators. Ongoing reviews o laser sa

procedures should be a part o normal o ce routine.


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4.6 In-O ce Saety Issues

4.6.1 Lighting

Always use the PILO in a well lit and ventilated area. Make certain that chemicals or gases capable o supporting or causing combust

are not present when using the laser. Use high volume vacuum to remove the laser plume and provide high fltration masks or

people present in the treatment area during lasing.

4.6.2 Saety Eyewear

While using the PILO, doctors, auxiliary sta, patients and anyone attending them in the operatory must wear the appropriate sa

eyewear that has been designed or the use with the 81nm wavelength. Never point the laser tip directly at the ace, eyes or skin o any

while emitting energy. Te aiming beam is also capable o causing eye damage.

4.6.3 Test Firing the Laser

Always test-fre the PILO prior to using it. o test fre the laser:

Using a power o 1 Watt continuous wave or less, place the laser in the ready mode.

Activate the laser or 1-2 seconds while aiming the fber onto a 2x2 gauze sponge wetted with water. Do not use alcohol

or any other combustible material to wet the 2x2 sponge as it may ignite.

4.6.4 Power Changes with Fiber Changes

Switching to a smaller diameter fber will increase the density o the power at the fber tip. As a result, you may need to adjust your po

downward. Increasing the power may be required when switching to a larger diameter fber. A smaller diameter fber will require l

power and conversely, a larger diameter will require more power.

4.6.5 Fiber Preparation

Aer cleaving and stripping the fber, photo-initiation o the fber tip will allow the operator to remove tissue more rapidly when con

procedures are indicated. Any debris on the tip will retain the heat and it should be removed. Te tip will begin to blacken and deterio

as it retains the heated debris and can break i not removed by cleaving. Clean the tip aer using a 2X2 gauze sponge moistened w

water. Do not use combustible liquids to moisten the 2X2 sponge.

4.6.6 Danger - Laser in Use Signage

Each area where a PILO is used should have a Laser In Use sign placed at the entrance when a procedure is in progress, this will heliminate eye damage caused by inadvertent exposure to laser energy.

4.6.7 Sharps Disposal and Sponge Removal

Remove cleaved fber remnants and place them into a sharps container or disposal. All sponges used or cleanup o lasers and fb

should be disposed o in a biohazard bag or contaminated so products.

4.6.8 Plume Evacuation

Use high volume evacuation suction during procedures to remove laser smoke o plume debris. Use masks suitable or viral fltrat

CAUTION: Laser plume may contain viable tissue particulates.

4.6.9 Key Switch and Mode Selection

When the key switch is in the ON position (turn to the right), the laser has been enabled and can be activated while in the READY staWhen not in use, insure the key has been turned o or that the laser is placed in the SANDBY status.

4.6.10 Saety Education

Provide comprehensive saety procedure training or all o ce personnel and include the sta in all outside laser courses when possi

Be certain that all members o the team understand how the laser works.

4.6.11 Laser Security

o prevent the unauthorized use o the laser while not in use, the key should be removed rom the unit and maintained by the Laser Sa

O cer.


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4.6.12 Emergency Shutdown Options

Any o these mechanisms can be used to shut down the emission o the laser energy in a real or perceived emergency.

1. Depress the emergency shutdown button

2. Foot Pedal - Remove your oot to stop lasing

3. Key urn o the key

4. Switch the Power/Fan to the o position (O)

5. Power Cord Unplug rom the wall outlet

4.6.13 Hard Tissue Procedures

Te PILO is not an appropriate laser or hard tissue procedures. Te diode laser is attracted to melanin, hemoglobin and to some ext

water and oxygenated hemoglobin.

4.7 American National Standards Institute (ANSI) Saety StandardsANSI is a non-governmental, nonproft agency that has established guidelines and saety standards or the use o lasers and ot

electro-optics. ANSI establishes guidelines or saety eyewear and classifes all lasers based on their potential or damage to eyes or tiss

You will also fnd inormation concerning lasers at Lasermet.com.

SECTION 5 OPERATING THE LASER

Te PILO will deliver energy in either a continuous wave (CW) mode or in a pulsed mode which are called temporal emission mo

(time related modes). Selecting the appropriate mode is a actor in controlling target tissue temperatures and the e ciency o ene

delivered. Te pulse duration (.5 seconds) and the number o pulses per second (1) have been fxed by the manuacturer using a 5

duty cycle and you will thereore need only to change the power and mode.

5.0 Standby and Ready Status

Once you have turned on the power/an switch on the back o the laser and the key switch on the ront, you will see the lasers L

screen light up. Te status o the laser will be in Standby, which is a non-active status. Te laser will not emit energy while in Standb

even i you depress the oot pedal. Press the READY button to place the unit in the ready status. When this button is pressed, whate

settings are displayed on the unit will be saved into the units memory or the program setting shown. Te settings saved into the th

programmable modes will be retained even i the laser is turned o. Any adjustments to the manual settings aer the laser is in the re

status will now be saved to memory. Te laser will now be ready to emit energy as you depress the oot pedal.

5.1 Continuous Wave (CW) Mode (see Figure 3.2 and 3.2a)

Te Continuous Wave (CW) mode, will deliver the amount o energy in joules in one second that you have set the laser or (i.e., set

laser or 2 Watts CW and while in the ready mode, the laser will deliver 2 joules o energy per second as long as you have the oot pe

depressed.). Te Continuous Wave mode is generally the astest way to ablate tissues; however heat may build up and cause collate

damage to the target and adjacent tissues. You may use water or air to cool areas that experience prolonged exposure to the lasers be

Avoid using compressed air when you have an opening in so tissue adjacent to, or within the surgery site. An air embolism may oc

as a result o air captured within the tissue during the cooling process.


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Figure 5.1 Fiber with a shard (a bad cleave)

5.2 Pulsed Energy Mode

Pulsing the laser will allow some cooling o the tissue in between emissions o energy. Te duty cycle is the percentage o the time

each second that the laser is emitting energy. Te pulses per second, the duty cycle and the energy intensity per pulse will determine y

average power. In the pulse mode the PILO is programmed to deliver 1. pulse per second with each pulse lasting or .5 secon

Te duty cycle is set or 5%, so you will have 1 energy pulse with 1 periods o rest with no energy between each pulse. I the lase

producing energy at 1 times per second or .5 seconds per pulse, you will be producing energy or a total o .5 seconds or ever

second the laser is active. Te result will be an average power per second that will be 5% o what you have set the laser or. When us

pulsed energy, you will have to adjust your power upward in order to achieve the same rate o work as the same power set in CW. 2 W

o Pulsed energy will be the same average power output as 1 Watt CW.

5.3 Tissue Responses to Laser Energy

Maximum results will be achieved by regulating the power and the speed that the operator moves the fber tip. issue charring is

undesirable aer eect o too much power or the tip moving too slowly. Always use the least amount o power necessary to comp

your procedure. Te ideal tissue response will show little or no discoloration aer lasing and there will be less residual damage and a

healing. Avoid penetrating or damaging bone. Check to make sure you have a good cleave o the fber so that no shard is present on

tip. A shard may act as a miniature scalpel and damage small blood vessels, thus preventing homeostasis and coagulation.

5.4 Fiber and Handpiece Care

Do not continue to use the fber tip once you have observed that the tip has a blackened appearance that is greater in length than 2-4m

rom the previous cleave spot. Te protein debris o so tissue accumulates on the tip during surgery and retains extreme heat that

cause rapid tip deterioration and subsequent breakage. Tis is especially important when using the laser in contact mode procedures

Clean the tip oen using a sponge or cloth moistened with water. Do not use alcohol or other combustible liquids and do not use

sponge while the tip is hot. Always use a cold disinectant solution to wipe o the fber jacket beore retracting the fber. Te fber cass

is a removable assembly with a plug-in capability that provides power or the internal retraction device. Tis cassette is disposable a

all fber has been used. Tis cassette is not autoclavable. Te handpeice should be autoclaved aer each patient and a new disposable

applied. Dispose o the cleaved tip in a Sharps waste receptacle. Be advised about the potential hazards when inserting, steeply bend

or improperly securing the fber optics to the chassis. Radiation exposure may occur in these instances which could be harmu

yoursel, you sta and your patient. Special care should be taken not to break or snap the fber. As the aiming beam passes down the sa

delivery system as the Working Beam, it provides a good method o checking or integrity o the delivery system. I the aiming beam sis not present at the distal end o the delivery system, its intensity is reduced or it looks diused, this is a possible indication o a dama

or not properly working delivery system.

5.5 WARNING

DO NOT PLACE THIS FIBER AND FIBER CASSETTE IN THE AUTOCLAVE TO STERILIZE THE SYSTEM. USE CO

DISINFECTING SOLUTIONS TO WIPE DOWN THE FIBER AND THE EXTERIOR OF THE LASER FIBER CASSETT


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5.6.1 Treatment Area Requirements

Te laser should be placed in an area with good ventilation and lighting, Te electrical service required is a 11 Volt AC out

6Hz. Te area where the laser is placed should be ree o standing water. Combustible gases should be turned o and all amma

materials or chemicals stored in the area should be removed.

5.6.2 Foot Pedal

It is recommended to use a 9 volt Lithium battery to power the cordless oot pedal. Tis type o battery has been tested to last

over 1 hours o oot pedal operation. When the battery voltage begins to drop, the oot pedal will begin to beep, signaling t

you have approximately 2 hours o operating time le beore the battery lie is completed. Note: A 9 volt Alkaline battery may

used; however the lie expectancy o an Alkaline battery is less than 35 hours o operating time.

5.6.3 Fiber Cassette

Beore using the laser, check the fber cassette to see that it is frmly seated. Depress the extend/retract rocker switch on the cass

to see that it is unctioning properly. Aer checking the fber cassette power, extend some fber rom the cassette.

5.6.4 Fiber Preparation (see Figure 3.7 and 3.7a on page 12)

You will want to have approximately 3 eet (1 meter) o fber available to strip the fber, cleave the fber, initiate the fber a

disinect the fber. When the fber is prepared the handpiece and tip should be attached. Once prepared place the handpiece i

the holder on the side o the laser. Te rocker switch or fber cassette operation should not be depressed during laser operatio

5.6.5 Emergency Shutdown Button

Check the Emergency Shutdown Button to see that it has not been depressed. I it has, release it by depressing it slightly as you t

it turn to the right.

5.6.6 Key Switch

urn the Key Switch on the ront o the laser to the on position by turning it approximately turn to the right (clockwise).

control panel should light up and show the laser is in the Standby Mode.

5.6.7 Setting Parameters (see Figure 3.2a on page 11)

Review your power and mode requirements and then depress the mode button to select either Continuous (CW) or pulsed-mo

Te mode you have selected will be displayed just below the LED screen and will be designated by a small light in the corner

either o the pulse or CW panel Display.

5.6.8 Select Your Power

Press the up or down arrow until you have reached the desired wattage. Beginning with a low o .1 Watts, the power increase

increments o 1 mW up to a maximum o 9. Watts (CW). By holding the up or down arrow, you can have an un-interrup

increase until you reach your desired power.

5.6.9 Selecting Programs

Press this key to select either manual (M) or one o three user defned programs (P1, P2, P3). Each program will save all o parameters working beam, aiming beam and mode o operation. Te settings can be changed as desired or any o the progr

modes. o set the user defned program modes, choose either P1, P2, or P3, set your preerred settings and push the ready butt

Upon activating the ready button, the new settings will be retained.

5.6 Systems Procedures


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5.6.10 Aiming Beam

Te aiming beam can be turned on and o by pressing the aiming beam button on the laser control panel. Press this button

progressively increase the aiming beam intensity rom O (o) to ull intensity. Press the key once more to cycle back to O. Ea

bar represents approximately 2% o the aiming beam output. Note: Adjusting the intensity o the aiming beam has no eect

the output power o the primary laser.

5.6.11 Examine the Fiber Tip

Insure that you have not created a fber tip shard during the cleaving process, the shard can act like a miniature scalpel and ca

damage while diusing the light beam and lowering the lasers power.

5.6.12 Depress the Ready Button

When you depress the ready button, the aiming beam should light aer a 2 second delay. Select either CW or pulse mode.

5.6.13 Test Fire the Laser

Away rom tissue, test fre the laser on a 2X2 gauze sponge that has been wetted with water.

5.6.14 Depress the Foot Pedal

Make short quick strokes at the lowest power to remove target tissue while lightly contacting it.

5.6.15 Remove Your Foot

Remove your oot rom the oot pedal and use a clean 2X2 wetted gauze to remove debris rom the fber tip.

5.6.16 Place the Laser in Standby Mode

Until you are ready to start another procedure, keep the laser in standby mode.

5.6.17 Cleave used Fiber Tip

Discard all cleaving and used fber tips in a bio-waste disposal.

5.6.18 Sel Diagnostic and Monitoring

When the PILOs microprocessor detects an issue with perormance it will immediately notiy you by way o an audible beTere are two dierent ways in which the PILO will alert you to any issues:

1. Continuous audible beep when oot pedal is engaged. I you are operating the PILO with the oot pedal engaged and t

PILO emits a constant audible beep and stops the beep when you release the oot pedal, the microprocessor has determin

that the laser power output has allen below the set level. In this event the PILO should be turned o and allowed to sit o

minutes then turned on again. I the PILO then perorms without beeping, the microprocessor has been able to make operatio

adjustments to the laser and the unit will perorm its unctions. I, however, upon restart the unit continues to beep when the

pedal is engaged, the microprocessor was unable to adjust the unit enough and the unit will need to be sent in or adjustm

(Section 6)

2. Continuous audible beep when the unit is turned on. I you are operating the PILO and it emits a constant audible b

whether or not the oot pedal is engaged, the microprocessor has determined that the laser has either low power or a general has occurred. In this event the PILO should be turned o and allowed to sit or 5 minutes and turned on again. I the PILO

then perorms without beeping, the microprocessor has been able to make operational adjustments to the laser and the unit

perorm its unctions. I, however, upon restart the unit continues to beep, the microprocessor was unable to adjust the unit eno

and the unit will need to be sent in or adjustment. (Section 6)


23/36 2

SECTION 6 SYSTEM COMPONENTS

PREPARATIONS, CARE AND MAINTENANCE

Te fber optic element o a laser is responsible or carrying the light rom the diode array to the tissue being treated. Laser fbers

usually made o quartz, sapphire, silica or a combination o those elements. Quartz/silica is the most popular product used in diode las

Be advised about the potential hazards when inserting, steeply bending or improperly securing the fber optics to the chassis. Radiat

exposure may occur in these instances which could be harmul to yoursel, you sta and your patient. Special care should be taken no

break or snap the fber. As the Aiming Beam passes down the same delivery system as the Working Beam, it provides a good method

checking or integrity o the delivery system. I the aiming beam spot is not present at the distal end o the delivery system, its intensit

reduced or it looks diused, this is a possible indication o a damaged or not properly working delivery system.

6.0 Disposable Fiber Cassette

Te fber cassette is a removable assembly with a plug-in capability that provides power or the internal retraction device. Tis cassett

disposable aer all fber has been used. Tis cassette is not autoclavable.

6.0.1 Replacing the Fiber Cassette

A white mark on the fber indicates 2 o fber remaining on the cassette. At this point, a new fber cassette should be ordered. When

cassette is empty, it should be released rom the laser aperture and gently removed. Slowly li the cassette up using the dove tail as a gu

Te fber cartridge can be thrown away.

Note: Do not discard the end cap. Review the installation procedure in Section 3.1.8

6.1 Fiber Preparation

Te fber cassette contains approximately 2 (6 meters+) and is wound onto a spool. Te fber itsel has three components:

Jacket

Cladding

4 micron quartz/silica fber

6.1.1 Jacket

Tis is the protective cover or the fber system and usually is made o a synthetic material that is clear or white in color, there arestandardized color systems to denote the diameter o the fber or its use.

6.1.2 Cladding

Tis is the material on the outside o the quartz/silica fber that is used to block the lateral escape o the laser energy as it traverses

fber. During stripping you may nick the cladding and you will likely see the red aiming beam light as it escapes the site o the dam

Tis is not a danger i all people in the area have the appropriate saety eyewear.

6.1.3 Quartz/Silica Fiber

Te fber is airly exible but can be broken i bent into a small circle or bent as an angle o 9. Te cladding will burn as protein r

the tissue accumulates on the fber and will deteriorate the tip. It can racture i not cleaved once the blackened area has reached 3-4m

Stop lasing and wipe o the tip regularly as you work to avoid accumulation o protein debris. Use water on a 2X2 gauze sponge to cle

the tip. Do not use ammable materials like alcohol products when cleaning a hot tip. Dispose o all small fber remnants aer you hcleaved the fber. Tey should be kept in a small box with a lid until they can be properly disposed o in the sharps container.


24/3624

Figure 6. Adjustable Fiber Stripper ool Figure 6.1 Removing Jacket with Stripper ool

Figure 6.1a Stripping the Jacket

6.1.4 Stripping the Fiber

Te fbers jacket is removed using the fber stripping tool. Once a fber tip is initiated and begins retaining debris rom the tissues duri

lasing, you will get a deterioration o the fber tip. When you have a blackened tip that extends 3-4mm up the fber sha, it is time

cleave the fber and strip the jacket to prepare or the next procedure. Begin by selecting enough jacket so that when it is removed, you w

have approximately 3/8 o bare fber exposed. Place the fber in the stripper and grasp that portion o the fber that will have the jack

removed between your thumb nail and index fnger (See Figure 6.). Grasp the fber with the stripper by applying pressure to the handl

With a slow steady orce, remove the jacket by pulling the fber away rom the stripper. (See Figure 6.1 and 6.1a)

6.1.5 Cleaving the Fiber:

As the tip deteriorates, it is more likely to racture and could all into the area you are lasing. o avoid this, it is prudent to periodic

cleave the discolored tip. Te cleave is made aer stripping o the jacket to expose approximately 1-4 3/8 o bare fber. Te clea

should be made at a point approximately 1/2 (8 1mm) rom the site o the previous cleave so that there is no visible discolorati

o the tip. Te operator should place their index fnger at the spot o the proposed cleave so as to stabilize the fber. Using the pen s

cleaver, draw the cleave blade across the top o the fber with enough pressure to score the fber. (See Figure 6.2). With the thu

and index fnger o each hand holding the fber at a spot approximately on either side o the cleave mark, break the fber against

cleave (See Figure 6.2a). Aer you have cleaved the fber, point it perpendicular to a white piece o paper and place the laser in REAmode. Hold the tip approximately rom the paper and you should see a near perect circle o red light, I you have a large comet e

radiation rom the circle, you have not obtained a good cleave. I the circle has just a small comet eect, it should work appropriately. (

Figures 6.3 and 6.4)

WARNING:

Always dispose o the fber tip remnants in the Sharps container immediately aer cleaving the fber.


25/36 2

Figure 6.2a Break the fber against the cleaveFigure 6.2 Scoring & Cleaving

Figure 6.4Bad Cleav

Figure 6.3

Good Clea

Move the tip le or right while lightly touching the paper

WARNING: Using too much power can start a fre on the

articulating paper

6.1.7 Fiber Disinection

Te fber and spool remain in the fber cassette and are not autoclavable while in the cassette. Once stripped, cleaved and initiated, tip will reach temperatures o several hundred degrees centigrade. Wipe the jacket down using Birex, Cidex or a comparable prodthat can disinect the jacket. Dry the jacket using a clean 2X2 sponge prior to retracting the fber into the fber cassette. (See section 6

6.2 Laser Maintenance

6.2.1 Laser Chassis Disinection

Te exterior o the laser should be cleaned using a liquid disinectant similar to Birex or Cidex . Do not spray the disinectant direon the chassis. Apply with a gauze sponge or wipe. Do not use abrasive materials to clean the system. Place a barrier material similacellophane over the control panel and LED screen prior to treating the next patient.

6.2.2 Calibration

Te PILO is calibrated at the actory, and requires no user adjustment or periodic calibration once the unit is in use. Te laser containternal calibration programming that continuously monitors and adjusts the working beam power relative to the actory establishreerence points, ensuring that the laser continuously provides the power output indicated on the display to an accuracy o 2

regardless o how long the unit has been in use. Te PILO uses solid-state circuitry to continuously monitor the power output, aadjusts the power supplied to the laser module to keep the output consistent with the user defned setting. I output levels are more th 2% o the set value, the unit is designed to shut down power to the laser, and an audible alarm will sound. I this happens, the ushould be turned o and allowed to sit or 5 minutes and turned on again. I the laser then perorms without beeping, the microproceshas been able to make operational adjustments and the unit will perorm its unctions. I, upon restart, the unit continues to beep, unit will need to be sent in or adjustment by the CAO Group Warranty Department.

6.1.6 Initiating the Fiber

Te tip o the fber should be cleaved to provide a at surace that can be prepared to retain heat by introducing it to a dark material ink, blood or water color paints. Te easiest way to prepare the tip is to lightly move the at surace o the tip across a piece o articulatpaper, the tip will retain the ink and ink will make the tip glow. Prolonged heating will accelerate the deterioration o the tip. (See Fig6.5)


26/36


27/36 2

6.3.6 Mounting the Tip

Aer selecting your tip, straighten it using your thumb and index fnger. Begin at the proximal end o the tip and eed the stripped

o the fber through the straightened tip until only bare fber is extending beyond the disposable tip. Gently slide the disposable tip o

the distal end o the handpiece and pull the fber rom the proximal end until the disposable tip is almost seated on the handpiece bo

Seat the disposable tip securely on the handpiece body and tighten the locking collar. You may now shape the disposable tip to the desi

orm. Press the rocker switch to make sure the fber moves reely. You should now initiate the fber tip i your procedure calls or it.

SECTION 7 LABELS, SIGNS, WARNINGS AND MANUFACTURERS INFORMATION

7.1 Federal Compliance

Te PILO has been certifed to the latest saety standards applicable to medical lasers in the US and Canada, including IEC 6825,

661-2-22, IEC 661-1 and the Food and Drug Administrations Laser Perormance Standard (21 CFR 14.1 and 14.11). Te la

has also been certifed and tested according to the telecommunications regulations or the US (FCC Part 15), Canada (IC RSS 21)

the European Community (EN 3 328, and EN 31 489). Various labels are included on the laser and the wireless ootswitch as evide

o conormity to these requirements. Te labels on the unit are required under these standards or saety purposes and should not

removed. Please review all labels prior to using the laser. (SEE Figures 7..1 through 7..1)

7.2 Danger Laser in Use

Each treatment area should have a laser in use warning sign posted at the entrance to the treatment area. Tis signage serves to w

people to not enter the treatment area without proper saety eyewear and protective clothing when the laser is in use. (See Figure 7.1

DANGERLASER RADIATION--AVOID

EYE OR SKIN EXPOSURE TO

DIRECT OR SCATTERED RADIATION

CLASS IV LASER PRODUCT

9.0W 810nm DIODE LASER

DO NOT RETRACT STRIPPED

FIBER INTO THE CARTRIDGE

DO NOT ACTIVATE LASERWITH FIBER RETRACTED

INTO THE CARTRIDGE

CAUTION

Figure 7..1 Label required

under FDA laser notice 5

Figure 7..2 Label requiredunder FDA laser notice 5

Figure 7..3 Laser aperture label

Figure 7.1

Do Not Reuse

Figure 7..6

Figure 7..7

Figure 7..8

Figure 7..9

Figure 7..1

AENION -- Review Operators

Manual Prior o Use

CAUION -- Laser Emitting

Device

ype B Applied Parts

Fuse Compartment -- Use ype

Fuse

Figure 7..4 Rating label

with serial number

NE VOUS ESCAMOTEZ PASENLEV FIBRE DANS

LA CARTOUCHE

NACTIVEZ PAS DE LASERAVEC LA FIBRE RTRACTE

DANS LA CARTOUCHE

ATTENTION

Figure 7..5 Fiber Cartridge Caution Label


28/3628

able 1 - Nominal Ocular Hazard Distance (NOHD) or various viewing conditions while wearing eye protection.

7.3 Class 4 Laser Product (treatment laser) 81nm 9 W

7.4 Aiming Beam Laser 63 66nm, 2 mW

7.5 CAUTION :

Changes or modifcations not expressly approved by CAO Group could void the users authority to operate the equipment.

7.6 CAUTION :

Laser Radiation Avoid exposure to the eyes or skin rom direct or scattered radiation.

7.7 CAUTION :

Tis product contains no user serviceable components within the chassis. Visible and invisible radiation may be present when the co

is removed.

7.8 CAUTION :

US Federal law restricts the device to sale by or on the order o a licensed proessional.

7.9 CAUTION :

Eyewear that protects your eyes rom wavelengths other than 81nm do not provide proper protection or use with this laser. Damag

the retina or corneal may be irreparable i exposed to direct, reected or scattered radiation.

7.10 CAUTION :

Use o controls or adjustments, or perormance o procedures other than those specifed herein may result in hazardous radiat

exposure.

7.11 Nominal Ocular Hazard Distance (NOHD)

Te NOHD is the distance beyond which the exposure during normal operation is not to exceed the appropriate Maximum Permiss

Exposure (MPE). Te NOHD or persons wearing saety glasses is shown in able 1 below. Te Nominal Hazard Zone (NHZ) is the a

where the laser source within which exposure levels exceeds the MPE (which is the highest level o laser radiation to which a person m

be exposed without hazardous eects or adverse biological changes in the eyes or skin). Te outer limit o the MHZ is the NOHD. EProtection within the NHZ is mandatory.

NOTE: Tis equipment has been tested and ound to comply with the limits or a Class A digital device, pursuant to Part 15 o

FCC Rules. Tese limits are designed to provide reasonable protection against harmul intererence when the equipment is opera

in commercial environment. Tis equipment generates, uses, and can radiate radio requency energy and, i not installed and used

accordance with the instruction manual, may cause harmul intererence to radio communications. (Operation o this equipment

a residential area is likely to cause harmul intererence, in which case the user will be required to correct the intererence at his o

expense.)


29/36 2

7.12 Warning and Saety Notices:

WARNING: o avoid the risk o electrical shock, this equipment must only be connected to a supply main with protective earth.

7.13 Environmental Protection Disposal O The Equipment:

Tis is a medical laser device; dispose o this device and all accessory items in accordance with state, local and ederal rules on the dispoo laser equipment.

7.14 Statements Regarding Electromagnetic Compatibility (EMC):

WARNING: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into serviceaccording to the EMC inormation provided in this manual.

Portable and mobile RF communications equipment can aect the perormance o the PILO Laser. Te use o accessories, transducers and cables other than those specifed by CAO Group may result in increasedemissions or decreased immunity o the PILO Laser.

Te PILO Laser should not be used adjacent to or stacked with other equipment and that i adjacent or stacked use isnecessary, the PILO Laser should be observed to veriy normal operation in the confguration in which it will be used.

SECTION 8 SERVICING

8.0 Warranty Policy:

Te PILO is warranted against deective materials and workmanship or a period o one (1) year rom the date o purchase, and wbe repaired or replaced, at our discretion, i returned prepaid to our actory. Tis warranty does not cover damage to the PILO unicomponents caused by accident, misuse, or being tampered with. Tis warranty does not include labor, postage, or delivery charges. Twarranty does not apply to the external fnish o the console, handpiece, fber, power cord, or oot pedal. CAO Group reserves the rito make changes in the design or to modiy such previously manuactured products. Your PILO warranty does not become eecunless the registration card is sent to CAO Group in the mail within ten (1) days o the purchase, with all invoice and serial numinormation completely flled in.

8.0.1 Repairs & ReturnsSend repair and returns to CAO Group Inc. Should the laser ail to operate correctly and your local dealer representative is unable to asyou, please call CAO Group Customer Service (1-877-236-449) to obtain a Return Goods Authorization (RGA) number or shipppurposes. Please insure that the RGA number is clearly marked on the box used to return the laser. Please clearly state the reasons return.Send returns to: CAO Group Attn: Warranty Department 4628 W Skyhawk Dr. West Jordan, U 8484 USA

CAUTION!Use o controls or adjustments or perormance o procedures other than those specifed herein may result in hazardradiation exposure.

CAUTION!Do not attempt to remove the cover rom the laser chassis or the purpose o repairing the laser. Serious injury romelectrical shock or laser radiation could occur. Removing the cover on the laser chassis will void the warranty.


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8.1 FDA And Laser Standards

Medical Laser Standards

Te PILO has been certifed to the latest saety standards applicable to medical lasers in the US and Canada including CAN/CSA c 2

#61.1, IEC 6825, IEC 661-2-22, IEC 661-1 and the Food and Drug Administrations Laser Perormance Standard (21 CFR 14

and 14.11), US (FCC Part 15) , Canada (IC RSS 21) and the European Community (EN 3 328, and EN 31 489). Various labels

included on the laser and the wireless oot switch as evidence o conormity to these requirements. Te labels on the units are requi

under these standards or saety purposes and should not be removed. Please review all labels prior to using the laser.

Wireless Technology

Tis device complies with Part 15 o the FCC Rules. Operation is subject to the ollowing two conditions: (1) this device may

cause harmul intererence, and (2) this device must accept any intererence received, including intererence that may cause undesira

operation. Te wireless ootswitch complies with US FCC, itle 47 (47 CFR); Canada, IC-RSS 21 (Radio Standards Specifcation);

European Community, EN 3 328, EN 695 and EN 31 489.

1. Tis device may not cause harmul intererence, and

2. Tis device must accept any intererence received, including intererence that may cause undesired operation.

NOTE: Tis equipment has been tested and ound to comply with the limits or a Class A digital device, pursuant to Part 15 o the F

Rules. Tis equipment generates, uses, and can radiate radio requency energy and, i not installed and used in accordance with

instruction manual, may cause harmul intererence to radio communications. (Operation o this equipment in a residential area is lik

to cause harmul intererence in which case the user will be required to correct the intererence at his own expense.)

OSHA and its Provisions

Worker saety is the responsibility o the employer and is regulated by OSHA (Occupational Saety and Health Administration), a divis

o the U.S. Department o Labor. OSHA has issued no specifc standard or sae use o lasers but recognizes ANSI standard Z136.1

source or analyzing saety with respect to medical lasers. For more inormation see OSHA echnical Manual (ED 1-.15A) Section

Chapter 6, 1999. CAO Group recommends implementation o a Laser Saety Program or the saety o your patients and o ce sta

connection with the use o the PILO Diode Laser.

American National Standards Institute(ANSI) - Saety Standards ANSI is a non-governmental, non-proft agency that has established guidelines and saety standards or

use o lasers and other electro-optics. Te provisions o ANSI Z 136.3 outline standards or lasers used in medicine and the assessm

o laser risks. ANSI establishes guidelines or saety eyewear, and classifes all lasers based on their potential or damage to eyes or tiss


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8.2 TROUBLESHOOTING

Learn more about PILO Laser at www.pilotlaser.com

CAO GROUP INC.

4628 W Skyhawk Dr.

West Jordan, UT 84084 USA

Call us toll ree at 1-877-236-449 in the U.S.

.


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INTRODUCTIONYour Pilot diode laser is equipped with two therapy attachments. Tese therapy

attachments aid in the use o the Pilot laser or bio-stimulation, wound therapy and

lameness therapy. Common treatments include:

Post surgical treatment o incision

Pre-surgical treatment or hemostasis

Wound and ulcer treatment

Hot spots

Granulomas

Inection treatment

Otitis Externa

Lameness treatment

Arthritis

Osteoarthritis

ATTACHMENTSwo sizes o Pilot therapy attachments are provided:

5 Watt (larger attachment)

3 Watt (smaller attachment)

Both therapy attachments are designed to provide optimum energy delivery, laser penetration

therapeutic benefts with the laser power at the indicated setting, used in direct contact with the tissue

medium pigmented tissue. Adjustments need to be made or darker/lighter pigment, hand speed and de

o penetration desired. With a little experience and visual observation, the clinician will quickly be ab

make necessary and skilled adjustments.

Tese attachments are easy to attach and easy to use ollowing these instructions.

1. Strip the end o the fber to 2mm using the measurements on the fber stripping tool.

Note: 2mm is the length o the metal coupling piece on the end o the attachment.

2. Cleave the end o the fber to assure a proper cleave.

3. Insert the fber through the black handpiece.

4. Insert the fber into the hole in the therapy attachment.

Note: the fber will stop when the fber jacket reaches the hole.

5. Connect the therapy attachment to the end o the handpiece.

6. ighten the cap on the handpiece to capture the fber in place

With the fber stripped to 2mm, the fber end will protrude beyond the metal coupling piece.

Te natural angle o the laser will result in treatment o the complete area at the end o the

attachment.

SELECTION OF ATTACHMENTTe selection o the attachment is simply a unction o the area to be treated. For small areas,

small limbs, etc. the smaller 3 Watt attachment is su cient. Te larger 5 Watt attachment

should be used or larger areas.


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USING THE PILOT THERAPY ATTACHMENTSTe ability o laser energy to penetrate and beneft deep tissue is based on several variables.

1. Power setting

2. Patient tissue pigment

3. Distance

4. Angle

5. Minimal intererence (hair/ur)

6. Hand Speed

Most o these variables are under the control o the clinician. Maximum laser penetration and beneft will be achieved i the clinician:

1. Adjusts the power setting to achieve a warmth sensation at the end o the attachment. Adjustments need to be considered or darker

and/or pale pigments.

2. Maintain handpiece attachment perpendicular to the area being treated.

3. For ulcer or surace wound treatment, keep the end o the attachment 1 cm rom tissue.

4. For deep tissue, muscle and joint treatment, place the end o the attachment in contact with the patient and use the sturdy end o the

attachment to move/displace the hair to achieve minimal obstruction or the laser.

5. I appropriate, use the sturdy attachment to provide stimulating massage while laser treating the area.

6. Maintain a slow and steady hand speed.

POWER SETTINGSTe power setting should be adjusted higher or lower based on the

depth o penetration desired, skin pigment, hair obstruction and

hand speed.

HAND SPEEDLaser energy does not penetrate instantly. Penetration or deep tissue therapy takes time. Hand speed should be adjusted to allow several seconds at

given point. A total therapy treatment will oen take rom 1 to 15 minutes.

TREATMENT FREQUENCYLike any other method o treatment, a single treatment is seldom adequate. Repeated treatments over a period o 1 2 weeks is generally recommen

reatments may range or multiple treatments per day to every couple o days. Over-treating in a single treatment does not compensate or mult

treatments. Tis does not work with antibiotics and it does not work with laser therapy.

CONTINUOUS MODE VS PULSE MODETe attachment power specifcation (5W/ 3W) is determined or continuous mode.

OBSERVATION AND VENTILATION PORTSTe therapy attachments are designed with open ports to aid observation and ventilation. Te clinician should closely observe the treatment to m

assure that hair is being displaced to remove obstructions and to make adjustments as necessary in power settings and hand speed.

Min Max Min Max

3 Watt Attachment 2 4.5 4 7

5 Watt Attachment 4 6.5 6 8

CONTINUOUS PULSE


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WOUND TREATMENT

3 Watt 5 Watt

1x1 1 min

2x2 3 min

3x3 5 min 2 min4x4 8 min 4 min

5 x 5 1 min 6 min

DEEP PENETRATION AND MUSCULOSKELATAL CONDITIONS

FELINE 3 Watt 5 WattCarpus/ arsus 2 min

Elbow 4 min 2 min

Shoulder 4 min 2 min

Stie 5 min 3 minHip Dorsal Aspect 2 min

Hip Ventral Aspect 2min

Neck 3 min 2 min

Back 6 min 4 min

CANINE

Pilot Laser Operator's Manual

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