CO2 Computer Pattern Generator (CPG) Operator Manual · System beeps 17 Turn on the pattern generator 17 Select the pattern number (pattern shape) 18 Select the pattern size 19

UltraScan™ Encore™

CO2 Computer Pattern Generator (CPG)

Operator Manual


0633-227-01, Revision C

This manual is copyrighted with all rights reserved. Under copyright laws,this manual may not be copied in whole or in part or reproduced in anyother media without the express written permission of Lumenis, Inc.Permitted copies must carry the same proprietary and copyright notices aswere affixed to the original. Under the law, copying includes translationinto another language.

Please note that while every effort has been made to ensure that the datagiven in this document is accurate, the information, figures, illustrations,tables, specifications, and schematics contained herein are subject tochange without notice.

Lumenis, the Lumenis Logo, and UltraPulse are registered trademarks ofLumenis, Inc. Coherent and the Coherent Logo are registered trademarksof Coherent, Inc. UltraScan, TrueSpot, Encore, CO

2 Lite, and CoolScan

are trademarks of Lumenis, Inc. Kodak is a registered trademark ofEastman Kodak Company. Puritan is a registered trademark of HardwoodProducts Company LP. Enzol and Cidezyme are registered trademarks ofJohnson & Johnson. Miltex is a registered trademark of Miltex Instru-ment Company, Inc.

Regulatory European Representative:Lumenis (Germany) GmbHHeinrich-Hertz-Strasse 3D-63303 DreieichGermany

Manufactured by Lumenis Ltd.P.O.B. 240Yokneam 20692Israel

© The Lumenis Group of CompaniesDecember 20060633-227-01Revision C


0633-227-01, Revision C

ContentsOPERATION 5

Preoperative Instructions 6Inspect the UltraScan Encore components 6Assemble the UltraScan Encore handpiece 8Attach the UltraScan Encore to the laser articulated arm 9Connect the communication cable 10Prepare smoke evacuation 11If desired, position a sterile draping sleeve 12Turn on the UltraScan Encore 13Perform the laser beam alignment check 14CoolScan™ mode 15

Intraoperative Instructions 17System beeps 17Turn on the pattern generator 17Select the pattern number (pattern shape) 18Select the pattern size 19Select the pattern density 20Pattern density versus pattern size 21Average Pattern Fluence 21UltraScan Encore pattern chart 22Select single pattern or repeat pattern 24

Single pattern mode (default setting) 24Repeat pattern mode 25Preview the pattern 26Select the energy or fluence 28Energy level and fluence 29Select the repetition rate or average power 30CO2 Lite™ mode 31Target and deliver the treatment beam 33

Postoperative Instructions 34


0633-227-01, Revision C

MAINTENANCE 35

Troubleshooting Guide 35Common problems and suggested solutions 35

Perform the Laser Beam Alignment Check 40Inspect and Clean the UltraScan Encore 42

Clean the external surface of the delivery system 42Inspect the UltraScan Encore optics 42Clean the UltraScan Encore optics 43Inspect the UltraScan Encore handpiece tip, handpiece tip inner tube, and spatula tip 44Clean the UltraScan Encore handpiece tip, inner tube, and spatula tip 44

Sterilize the UltraScan Encore handpiece tip, handpiece tip inner tube, and spatula tips 45Specifications 46Warranty Information 47Decontamination of Returned Equipment 47

SAFETY AND REGULATORY 49

Laser Safety Eyewear 50Additional Ocular Protection 53Additional Safety Considerations 54

Fire hazards 55Nontarget tissues may be protected in a variety of ways 55

Regulatory Compliance 56Location of regulatory and other system labels 56

INDICATIONS FOR USE 57

DECONTAMINATION CERTIFICATE 59


0633-227-01, Revision C

Operation

The UltraScan Encore computerized pattern generator (CPG) combinesunsurpassed uniformity and speed for accurate, repeatable skin resurfac-ing. The treatment beam is collimated, so the spot size and fluence remainconstant at virtually any distance from the target tissue. The UltraScanEncore generates precise, repeatable patterns allowing treatment of largeareas quickly, with uniform fluence.

Lumenis lasers and delivery systems are precision medical instruments.They have undergone extensive testing and with proper handling areuseful and reliable clinical instruments. If you have questions regardingyour laser or delivery system, contact your local Lumenis representative.

WARNINGLasers generate a highly concentrated beam of light whichmay cause injury if improperly used. To protect the pa-tient and operating personnel, the entire laser and theappropriate delivery system operator manuals, includingall Safety and Regulatory sections, should be carefully readand comprehended before operation.


0633-227-01, Revision C

Preoperative Instructions

The UltraScan Encore is shipped clean and nonsterile from the factory.Before using the device in a sterile procedure, sterilize the handpiece tip,handpiece tip inner tube, and spatula tip. Cleaning and sterilization in-structions are detailed in the Maintenance section of this manual.

Most nursing staff prefer to inspect the delivery system components andto perform a laser beam alignment check daily, usually prior to scheduledcases and before patients are premedicated. Doing so ensures adequatetime to troubleshoot a problem or seek professional service with the leastdisruption to patient care.

You may perform these routine surgical tasks outside of the sterile field;however, if so, ensure enough time for sterilization before scheduled cases.

Inspect the UltraScan Encore components

When unpacking the delivery system, and before each use, inspect for dirt,debris, or damage. If assembled, disassemble the UltraScan by unscrewingthe handpiece tip inner tube to separate the handpiece body from thehandpiece tip (see the handpiece illustration on the following page). In-spect the inside of the handpiece tip to ensure that it is clean of anyresidual laser plume contamination or dirt. The input and output opticsin the handpiece body should appear translucent, smooth, bright, and freeof any cracks, spots, debris, or obvious damage. If cleaning is required,follow the instructions provided in the Maintenance section of thismanual. If the device appears damaged, contact your local Lumenis servicerepresentative.


0633-227-01, Revision C

Inspect the UltraScan Encore components

UltraScan Encore handpiece

Communicationcable clips

Communicationcable

Standard spatula tip


0633-227-01, Revision C

Assemble the UltraScan Encore handpiece

The handpiece tip inner tube screws the handpiece tip onto to the hand-piece body. Ensure that the handpiece tip inner tube, handpiece tip, andhandpiece body are secure and locked into place prior to use.

➟

➟

UltraScan Encore assembly/disassembly

Handpiece tip inner tube

Handpiece tip

Handpiece body


0633-227-01, Revision C

Attach the UltraScan Encore to the laser articulated arm

Before attaching the UltraScan Encore to the laser, verify that the laserkeyswitch is in the off position.

Attach the UltraScan Encore to the laser articulated arm by screwing thehandpiece body onto the threaded end of the articulated arm. Ensure thatthe UltraScan Encore is secure and will not loosen during use.

Attach the UltraScan Encore to the laser articulated arm

Laserarticulated arm

➟


0633-227-01, Revision C

Communicationcable

Connect the communication cable

The UltraScan Encore is controlled by laser system software. The UltraS-can Encore communication cable provides constant communication be-tween the laser and the UltraScan Encore handpiece. Treatment param-eters are selected with the laser control screen and monitored by the lasersystem software via the communication cable.

1. Insert the communication cable plug into the receptacle on the rear ofthe laser.

2. Insert the opposite end of the communication cable into the commu-nication receptacle on the UltraScan Encore handpiece.

3. Secure the communication cable along the length of the articulatedarm with the communication cable clips, as shown in your UltraPulseEncore Operator’s Manual.

Connect the communication cable to the UltraScan Encore handpiece

➟


0633-227-01, Revision C

Prepare smoke evacuation

If smoke evacuation is desired, attach 22 millimeter (7/8 inch) innerdiameter evacuation tubing to the smoke evacuation port.

WARNINGSmoke evacuation of approximately 15 lps (32 cfm), ormore, is highly recommended with the use of this product.If smoke evacuation is not used, laser plume debris mayaccumulate on the output lens, causing lens damage, de-creased energy transmission, or unintended, adverse tissueeffect.

Attach smoke evacuation tubing

➟


0633-227-01, Revision C

If desired, position a sterile draping sleeve

If desired, position a sterile draping sleeve over the delivery system, asshown.

Position a sterile draping sleeve


0633-227-01, Revision C

Turn on the UltraScan Encore

1. Turn on the laser with the laser keyswitch. Wait a few minutes whilethe laser performs a self-test. If the UltraScan Encore is properlyconnected to the laser, the CPG controls will display on the lasercontrol screen. The UltraScan Encore controls will remain dimmedand unavailable until you press the CPG on selector.

2. The red aiming beam should exit from the UltraScan Encore hand-piece. If necessary, adjust the aiming beam intensity with thetouchscreen controls, as shown in your UltraPulse Encore Operator’sManual.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

1-6-5

S0.5®

®

6

1 2 3 CO2 Lite™

5

1

1-6-5I

6 5

1-6-515.3 J/cm2

1 -6-515.3 J/cm2

UltraScan Encore controls


0633-227-01, Revision C

Perform the laser beam alignment check

Perform the beam alignment check as described in the Maintenance sec-tion of this manual or in the Quick Reference Guide included with thismanual.

Most nursing staff prefer to perform a laser beam alignment check daily,usually prior to scheduled cases and before patients are premedicated.Doing so ensures adequate time to troubleshoot a problem or seek profes-sional service with the least disruption to patient care.

WARNINGBeam alignment checks are extremely important for thesafe operation of your laser equipment. Do not use thelaser or delivery system if aiming and treatment beams arenot coincident; call your local Lumenis service representa-tive. Misalignment of aiming and treatment beams mayresult in laser exposure to nontarget tissues and possibleinjury.


0633-227-01, Revision C

CoolScan™ modeCoolScan mode offers non-linear delivery of the treatment beam. Whenscanning a pattern in CoolScan mode, the laser delivers the treatmentbeam to spots in the pattern non-contiguously.

CoolScan mode is controlled from the Options screen. To turn CoolScanmode on or off, first push the Options tab at the top of the display screen.The Options screen appears on the display.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

S0.5®

®

6

1 2 3 CO2 Lite™

51-6-5

15.3 J/cm2

Options screen selection tab


0633-227-01, Revision C

Then, push the on button to activate CoolScan mode, or push the offbutton to deactivate it. When CoolScan mode is deactivated, the treat-ment beam is delivered in a linear, row by row sequence to spots withinthe pattern.

CWUltraPulse™

®

®

English

I II

CoolScan™

English

I

CoolScan™

CoolScan mode on/off controls

CoolScan mode on CoolScan mode off


0633-227-01, Revision C

Intraoperative Instructions

As directed in your laser operator manual or Quick Reference Guide,prepare the treatment room and verify that the laser is turned on and instandby mode.

System beeps

The laser will emit a single beep with every control screen selection, and along, low beep when a minimum or maximum setting is reached or whenan error has occurred.

Turn on the pattern generator

Press the CPG on selector on the control screen to activate the UltraScanEncore controls. The UltraScan Encore controls will change color toindicate that they are enabled.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

1-6-5

S0.5®

®

6

1 2 3 CO2 Lite™

5

I

1-6-515.3 J/cm2

Pattern generator on/off control

CPG on CPG off


0633-227-01, Revision C

Select the pattern number (pattern shape)

Select the desired pattern with the pattern number selectors. An outline ofthe selected pattern shape will appear in the pattern display. The numberof available patterns will depend upon your laser model.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

1-6-5

S0.5®

®

6

1 2 3 CO2 Lite™

5

1

1-6-515.3 J/cm2

Pattern shape controls


0633-227-01, Revision C

Select the pattern size

Select the desired pattern size with the size selectors. The pattern sizenumber will appear in the pattern size display.

Depending upon your laser model, some pattern sizes may not be avail-able at lower pattern density settings. If you attempt to select a pattern sizethat is incompatible with the existing density setting, the system will emita long, low beep, indicating that the selection is not available.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

1-6-5

S0.5®

®

6

1 2 3 CO2 Lite™

5

6

1-6-515.3 J/cm2

Pattern size controls


0633-227-01, Revision C

Density 1(–10%)

Density 2(0%)

Density 4(20%)

Density 8(50%)

Select the pattern density

Pattern density refers to the overlap of individual treatment spots in apattern. The following illustration provides an example of several patterndensity settings and the relative position of treatment spots:

Pattern density settings and resultant spot overlap

Select the desired pattern density with the density selectors. A densitynumber will appear in the pattern density display.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

1-6-5

S0.5®

®

6

1 2 3 CO2 Lite™

5

5

1-6-515.3 J/cm2

Pattern density controls


0633-227-01, Revision C

Pattern density versus pattern size

The pattern density setting takes precedence over the pattern size setting.At lower density settings, some pattern sizes may not be available, becausethose settings would cause a portion of the pattern to be clipped as thetreatment beam exits the handpiece. If you select a pattern density that isincompatible with the existing pattern size, the pattern size will decreaseto accommodate the change in density, and the system will display amessage indicating the parameter change. Because of this relationshipbetween pattern density and pattern size, it is important to always previewthe pattern before beginning a procedure. See “Previewing the pattern”later in this chapter for details.

NOTEPattern density is calculated from theoretical values, butclinical results depend on factors such as energy and tissuewater content. Pattern density should always be set to theminimum level and then increased to achieve the desiredtissue response.

The table below identifies the pattern density percentage for each patterndensity number, along with the pattern sizes available at that density.Note that some of the pattern sizes may not be available on your lasermodel.

1

-10%

1-5

2

0%

1-6

3

10%

1-7

4

20%

1-8

5

30%

1-9

6

35%

1-9

7

40%

1-9

8

50%

1-9

9

60%

1-9

Pattern DensityNumber

Pattern DensityPercentage

AvailablePattern Sizes

Available pattern sizes for each pattern number

Average Pattern Fluence

When the CPG is active, the average pattern fluence is displayed withinthe CPG window. The average pattern fluence indicates the effect that thepattern density factor has on the fluence of the total treatment pattern.This value is calculated by taking the total energy within a pattern anddividing it by the average effective pattern area scanned.


0633-227-01, Revision C

UltraScan Encore pattern chart

The UltraScan Encore pattern chart, with all available shapes and sizes, isshown below.

NOTEThe patterns available are determined by your laser model.Some patterns may be unavailable on your laser. Thenumbers assigned to each pattern, however, are the sameregardless of the laser model.

11

12

13

14

15

16

17

18

19

21

22

23

24

25

26

27

28

29

31

32

33

34

35

36

37

38

39

41

42

43

44

45

46

47

48

49

61

62

63

64

65

66

67

68

69

77

78

79

51

52

53

54

55

56

57

58

59

71

72

73

74

75

76

UltraScan Encore pattern chart


0633-227-01, Revision C

Each pattern on the UltraScan Encore pattern chart has a unique two-digit number. The first digit is the scan pattern shape number, and thesecond digit is the pattern size.

45

1 6

11

12

13

14

15

16

17

18

19

21

22

23

24

25

26

27

28

29

31

32

33

34

35

36

37

38

39

41

42

43

44

45

46

47

48

49

61

62

63

64

65

66

67

68

69

77

78

79

51

52

53

54

55

56

57

58

59

71

72

73

74

75

76

16

UltraScan Encore pattern numbers


0633-227-01, Revision C

Select single pattern or repeat pattern

Single pattern mode (default setting)

In single pattern mode, UltraScan Encore delivers one complete treat-ment pattern each time you press the footswitch. To deliver additionalpatterns, release and press the footswitch again.

To select single pattern mode, push the repeat delay off button.

NOTEReleasing the footswitch will interrupt treatment immedi-ately, even if the pattern is incomplete.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

1-6-5

S0.5®

®

6

1 2 3 CO2 Lite™

5

I

1-6-515.3 J/cm2

Repeat delay on/off

Repeat delay on Repeat delay off


0633-227-01, Revision C

Repeat pattern mode

In repeat pattern mode, UltraScan Encore repeatedly delivers patterns atthe selected interval, until the footswitch is released. For example, if youselect a repeat delay of 1.5 seconds, the laser will deliver a completepattern, wait 1.5 seconds, deliver another complete pattern, wait 1.5 sec-onds, and so on, repeating the cycle until the footswitch is released.

Select the desired repeat delay interval by pushing the “+” and “-” buttonson the repeat delay status bar.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

1-6-5

S0.5®

®

6

1 2 3 CO2 Lite™

5

S0.5I

1-6-515.3 J/cm2

Repeat delay setting controls

Setting controls


0633-227-01, Revision C

Preview the pattern

The UltraScan Encore aiming beam shows the outline of a selected pat-tern shape.

CAUTIONBefore beginning a procedure, always preview the pattern.Repeat the pattern preview instructions during treatmentif the pattern is changed, if single pattern is changed torepeat pattern, if pattern density is changed, or if the timedelay between patterns is adjusted. Delivering the treat-ment beam to the treatment site before previewing thepattern may result in unintended tissue interaction.

1. Moisten a tongue depressor with a nonflammable solution.

2. Set laser energy to 50 millijoules.

3. Position the UltraScan Encore so that the aiming beam is centered onthe depressor. If using a spatula tip, the tip should touch the tonguedepressor. If a spatula is not used, position the distal end of thehandpiece approximately 50 millimeters (2 inches) from the tonguedepressor.

CAUTIONNever discharge the laser without a target to absorb it andwithout consideration given to what lies behind the target.It may be desirable to place energy-absorbing materialbehind a target area. Laser energy can penetrate thetongue depressor and ignite any underlying flammablematerial; care should be taken to ensure that the patternpreview procedure is not performed in line with the pa-tient or operating room personnel or materials.

4. Press the ready selector to place the laser in ready mode.


0633-227-01, Revision C

5. Press the footswitch. If the repeat delay is off, release the footswitchwhen the treatment beam stops. If the repeat delay is on, release thefootswitch after observing the onset time delay between the patterns.

6. Examine the laser burn pattern. Adjust the pattern size and patterndensity, as required. Adjust the repeat delay setting, if desired. If thepattern is adjusted or the repeat delay setting is changed, repeat thepreview procedure.

7. Press the standby selector to place the laser in standby mode.


0633-227-01, Revision C

Select the energy or fluence

You can set the energy or fluence levels on the display screen by pushingthe appropriate button and adjusting the settings with the “+” and “-”buttons on the status indicator bar. In the illustration below, the fluencebutton is active.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

1-6-5

S0.5®

®

6

1 2 3 CO2 Lite™

5

J

J/cm27.5 J/cm2

100 mJ

1-6-515.3 J/cm2

Select the energy or fluence

Energy button

Fluence button

Setting controls


0633-227-01, Revision C

Energy level and fluence

In pulsed lasers such as the UltraPulse, fluence, or energy density, deter-mines the nature of the thermal effect on target tissue. Fluence is definedas energy per unit area and is measured in Joules per square centimeter(J/cm2). Ablation of tissue with minimal thermal artifact requires pulsefluence above a critical value of approximately 5 J/cm2. 1 The shaded areain the following table highlights this critical range and shows fluencevalues at various spot sizes and energy settings. For reference, the tablecompares the fluence values of a 1.3 millimeter spot (available with Ul-traScan Encore) with the fluence of a 3.0 millimeter spot (available withthe Lumenis TrueSpot™), and the fluence of a 2.25 millimeter spot(available with the Lumenis UltraScan).

CAUTIONThe table values are approximations and will vary withslight changes in spot size. The table should not be used toset treatment parameters, but simply as a guide to fluenceand its relationship with laser energy and spot size. Serioustissue damage can occur as a result of incorrect energysettings; use the lowest acceptable energy settings untilyou are familiar with the UltraScan Encore’s capabilities.

Pulse fluence at various energy settings

Fluence (in Joules/cm2)

Laser Energy(in millijoules)

25

50

100

125

150

200

225

250

300

350

400

450

500

0.60

1.30

2.50

3.20

3.80

5.00

5.70

6.30

7.60

8.80

10.00

11.30

12.60

Spot Size of2.25 millimeters

(UltraScan)

0.35

0.70

1.40

1.75

2.10

2.80

3.20

3.50

4.20

5.00

5.60

6.30

7.00


(TrueSpot)

1.90

3.75

7.50

9.40

11.30

15.00

17.00

18.80

22.60

26.30

30.10

33.80

37.60


(UltraScan Encore)


0633-227-01, Revision C

Rate button

Power button

NOTEAs explained fully in the “Energy level and fluence” sec-tion of this manual, the shaded area of the above tableshows the critical range where the combined spot sizes andenergy settings produce a pulse fluence of greater than orequal to 5 J/cm2.

CAUTIONAs indicated in the table, fluence is inversely related tospot size; for any constant energy setting, fluence will de-crease as spot size is increased. For this reason, any increasein spot size must be accompanied by a correspondingincrease in energy setting if an equivalent fluence is de-sired. The UltraScan Encore produces a fixed 1.3 millime-ter spot. If you switch to a different handpiece during aprocedure, you will need to make appropriate changes inenergy selection.

Select the repetition rate or average power

You can set the rate or power levels on the display screen by pushing theappropriate button and adjusting the settings with the “+” and “-” buttonson the status indicator bar. In the illustration below, the rate button isactive.

CWUltraPulse™

J

J/cm2

Hz

W

I

I

1

7.5 J/cm2

100 mJ

600 Hz60 W

1-6-5

S0.5®

®

6

1 2 3 CO2 Lite™

5

Hz

WHz

W600

60

1-6-515.3 J/cm2

Select the repetition rate or average power


0633-227-01, Revision C

CO2 Lite™ mode

CO2 Lite mode is a subset of the UltraPulse CPG mode, using the CPG

handpiece to perform light skin resurfacing. It is selectable only when theCPG handpiece is plugged in. This technique recommends using only asingle pass over the treatment area.

To enter CO2 Lite mode, push the CO

2 Lite button. The CO

2 Lite

settings appear on the display screen, and “CO2 LITE MODE –SINGLE PASS RECOMMENDED” appears in the help bar area. CO

2

Lite mode uses parameters suggested for a single pass with the CPG. Thedefault CO

2 Lite parameters are as follows:

Fluence: 2.25 J/cm2

Repetition rate: 600 HzPattern density: 5Repeat exposure: Off

The only parameters that are limited from normal function in CO2 Lite

mode are fluence and pattern density; all other controls remain fullyadjustable. Fluence and pattern density are limited to the following pa-rameters:

Fluence: 2.25–3.75 J/cm2

Pattern density: 3–6

If fluence or pattern density is adjusted out of the approved parameters,the system will go into standby mode, emit a beep, and “CO2 LITEEXITED” will be displayed in the help bar area. You must confirm thismessage by pushing the arrow button in the help bar area. You may thenreenter CO

2 Lite mode by pushing the CO

2 Lite button.


0633-227-01, Revision C

CO2 Lite button

CWUltraPulse™

J

W

I

1

2.25 J/cm2

100 mJ

600 Hz60 W

S0.5®

®

6

1 2 3 CO2 Lite™

5

I

J/cm2

Hz

1-6-515.3 J/cm2

CO2 Lite mode


0633-227-01, Revision C

Target and deliver the treatment beam

1. If desired, turn on the smoke evacuation.

NOTEWhen using the handpiece smoke evacuation port, use thesmoke evacuation spatula tip in contact with the skin. Ifthe smoke evacuation spatula is not used, a secondarysmoke evacuation system may be necessary.

2. Set the laser treatment parameters.

WARNINGSerious tissue damage can occur as a result of incorrecttreatment settings; it is recommended that the lowest ac-ceptable energy, rate, and density settings be used untilfamiliar with the UltraScan Encore’s capabilities.

3. Press the ready selector to place the laser in ready mode.

WARNING

Verify that all persons in the treatment room are wearingappropriate laser safety eyewear before placing the laser inready mode.

NOTEIf the laser is not used for 10 minutes, the system returnsto standby mode.

4. Position the UltraScan Encore over the target tissue and preview theaiming beam pattern.

NOTEDuring treatment, continuously verify that the aimingbeam shows the outline of the desired pattern. If it doesnot, immediately stop treatment. Place the laser in standbyand reselect the desired pattern number, size, and density.Preview the pattern once again. If the aiming beam pat-tern is still incorrect, contact your local Lumenis represen-tative.

5. Press the footswitch to deliver the treatment beam to the target tissue.


0633-227-01, Revision C

6. To turn off the UltraScan Encore, press the CPG off selector. TheUltraScan Encore controls and displays change color to indicate thatthey are disabled.

Postoperative Instructions

1. Press the standby selector to place the laser in standby mode and turnoff the laser.

2. Turn off smoke evacuation and remove sterile draping, if used.

3. Disconnect the communication cable from the UltraScan Encorehandpiece.

NOTEDo not pull on the cable—pull on the connector to dis-connect.

4. Disconnect the UltraScan Encore handpiece from the laser articulatedarm.

5. Remove the spatula tip from the handpiece body.

6. If used, remove smoke evacuation tubing.

7. Clean the UltraScan Encore as described in the Maintenance section.

Notes

1. Fitzpatrick, R.E., J. Ruiz-Esparza, M.P. Goldman, “The Depth ofThermal Necrosis Using the CO

2 Laser: A Comparison of the

Superpulsed Mode and the Conventional Mode.” Journal of Derma-tology and Surgical Oncology, 1991, Vol 17, pages 340–344.


0633-227-01, Revision C

Troubleshooting Guide

If the instrument fails to operate properly, this troubleshooting guidewill help you to locate and correct the malfunction. First, please checkfor the following items:

1. Electrical power source…verify that the electrical disconnect switch,the circuit breaker, is turned on.

2. Laser console electrical…verify that the laser is on and properlyconnected to an electrical service outlet.

3. Delivery system connections…verify that the delivery system isproperly connected.

4. External door interlock...if the external door interlock is used inconjunction with a remote switch, verify that the external doorinterlock plug is inserted in the external door interlock receptacle.Close the interlocked door.

Common problems and suggested solutions

If your problem is not listed in the following pages, refer to the Trouble-shooting Guide in your laser operator manual. If none of the suggestionsresolve your problem, the delivery system may be damaged, the laserarticulated arm may be out of alignment, or there may be an internallaser system failure; contact your local Lumenis service representative.

Maintenance


0633-227-01, Revision C

The aiming beam pattern is present, but no treatment beam is produced.

Probable Cause: Laser ready mode not selected.Suggestion: Select laser ready mode on the laser system control screen. If laser

ready is selected, contact Lumenis Service.

Pattern is not complete.

Probable Cause: Footswitch was released before the pattern was complete.Suggestion: Keep footswitch depressed or increase the rate to complete a pattern.

Spot does not appear round.

Probable Cause: The handpiece is held at an angle to the treatment tissue.Suggestion: Place the handpiece perpendicular to the treatment tissue.

CPG controls on the laser control screen are replaced by Timed Exposure controlsduring a procedure.

Probable Cause: The communication cable is disconnected.Suggestion: Verify that the communication cable plugs are completely seated in

the receptacle on the laser console and the UltraScan Encore body. Ifpattern generator controls still do not display, contact your localLumenis representative.

Screen controls do not respond when pressed.

Probable Cause: A laser software error has occurred.Suggestion: Turn off the laser using the keyswitch, wait five seconds, and turn on

the laser again. Verify settings and resume procedure.


0633-227-01, Revision C

“Handpiece Disconnected” advisory message appears on the control screen.

Probable Cause: The communication cable is not properly connected to the laser or tothe delivery system. It may be loose, disconnected, or broken.

Suggestion: Ensure that the communication cable is securely plugged into thecommunication cable receptacles on the laser and on the deliverysystem. If the problem persists, contact your local Lumenis servicerepresentative.

“Connect Footswitch” advisory message appears on the control screen.

Probable Cause: The footswitch is not properly connected to the laser console.Suggestion: Ensure that the footswitch is properly connected to the laser console.

“Release Footswitch Before Entering Ready Mode” advisory message appears on thecontrol screen.

Probable Cause: The footswitch has been depressed while trying to enter ready mode.Suggestion: Release the footswitch. Press the flashing arrow button to acknowl-

edge the message, then press the checkmark button to clear the mes-sage. The laser is put into standby; press the ready button to continue.

“Remote Interlock” advisory message appears on the control screen.

Probable Cause: The remote interlock has been activated by the opening of an inter-locked door or the interlock plug is not properly connected.

Suggestion: Close the interlocked door or connect the interlock plug.

“Density Forced Pattern Size Change” advisory message appears on the control screen.

Probable Cause: A pattern density has been selected that is incompatible with thecurrent pattern size. The pattern size has been changed to accommo-date the selected pattern density.

Suggestion: Select a pattern density and pattern size that are compatible. Press theflashing arrow button to acknowledge the message, then press thecheckmark button to clear the message. The laser is put into standby;press the ready button to continue.


0633-227-01, Revision C

“Density Blocked Pattern Size Change” advisory message appears on the control screen.

Probable Cause: A pattern size has been selected that is incompatible with the currentpattern density.

Suggestion: Select a pattern density and pattern size that are compatible. Press theflashing arrow button to acknowledge the message, then press thecheckmark button to clear the message. The laser is put into standby;press the ready button to continue.

“CO2 Lite Mode – Single Pass Recommended” advisory message appears on the controlscreen.

Probable Cause: The CO2 Lite button has been pushed, placing the laser in CO

2 Lite

mode.Suggestion: Press the flashing arrow button to acknowledge the message, then

press the checkmark button to clear the message. The laser is put intostandby; press the ready button to continue.

“CO2 Lite Exited” advisory message appears on the control screen.

Probable Cause: Fluence or pattern density has been adjusted out of the approvedparameters for CO

2 Lite mode. The laser is placed in UltraPulse

modeSuggestion: Press the flashing arrow button to acknowledge the message, then

press the checkmark button to clear the message. The laser is put intostandby; press the ready button to continue.

“Energy High” advisory message appears on the control screen.

Probable Cause: The laser detected a higher level of energy than the level selected bythe user.

Suggestion: Press the flashing arrow button to acknowledge the message, thenpress the checkmark button to clear the message. The laser is put intostandby; press the ready button to continue. If the condition persists,contact your local Lumenis service representative.


0633-227-01, Revision C

“Energy Low” advisory message appears on the control screen.

Probable Cause: The laser detected a lower level of energy than the level selected by theuser.

Suggestion: Press the flashing arrow button to acknowledge the message, thenpress the checkmark button to clear the message. The laser is put intostandby; press the ready button to continue. If the condition contin-ues, turn the system off for five seconds, and then turn it back on. Ifthe condition persists, contact your local Lumenis service representa-tive.

“Coolant Warm” advisory message appears on the control screen.

Probable Cause: The coolant in the laser is beginning to overheat.Suggestion: Verify that nothing is blocking the front or rear vents on the laser.

Verify that there is adequate space between the laser system and wallsor other treatment room equipment. Allow the system to run withoutdepressing the footswitch for 5 minutes or until the “Coolant Warm”advisory message clears.

“Coolant Too Hot” advisory message appears on the control screen.

Probable Cause: The coolant in the laser is overheating.Suggestion: Verify that nothing is blocking the front or rear vents on the laser.

Verify that there is adequate space between the laser system and wallsor other treatment room equipment. Allow the system to run withoutdepressing the footswitch for 5 minutes or until the “Coolant TooHot” advisory message clears.


0633-227-01, Revision C

3–5 cm(1.25–2 in)

Position theUltraScan Encore

Perform the Laser Beam Alignment Check

WARNINGDo not use the laser or delivery system if the aiming andtreatment beams are not aligned, or if the test burn isunacceptable; contact your local Lumenis service represen-tative. Misalignment may result in laser exposure to non-target tissues and possible injury.

WARNINGDo not perform the beam alignment check near or in-linewith the patient, other personnel, or flammable material.Laser energy can penetrate a tongue depressor and igniteunderlying flammable material, causing possible injury. Itmay be desirable to place energy-absorbing material be-hind a target area.

1. Verify that all persons in the treatment room are wearing laser safetyeyewear.

2. Mark an “X” on a wooden tongue depressor and moisten with water.

3. Turn on the laser.

4. Verify that CPG mode is active.

5. Set the laser energy to 50 millijoules.

6. Set pattern size to 1. There is no need to adjust pattern or density.

7. Place the laser in ready mode.

8. Position the UltraScan Encore approximately 3 to 5 centimeters (1.25to 2 inches) from the tongue depressor, as shown in the illustration onthe left. If using a spatula tip, steady the handpiece by touching thespatula to the tongue depressor. Adjust the aiming beam intensity onthe laser until the aiming beam is bright enough to be viewed undernormal ambient light.


0633-227-01, Revision C

Acceptable Unacceptable

Acceptable Unacceptable

9. Direct the aiming beam at the center of the “X,” and depress the laserfootswitch. Observe the burn; a round, evenly distributed spot shouldappear on the tongue depressor, as shown.

10. Reposition the aiming beam at the center of the “X” and verify thatthe burn lies within the area of the aiming beam, as shown:

If the burn is not within the aiming beam, if the burn is unacceptable,or if the aiming beam is not visible:

• Verify that the UltraScan Encore handpiece is securely attached tothe articulated arm.

• Verify that the “Up” arrows on the articulated arm knuckles arepointing upward.

• It may be helpful to move the articulated arm or rotate the articu-lated arm knuckles closest to the UltraScan Encore. Sometimeschanging the orientation of the articulated arm knuckles can affectaiming beam transmission, particularly if the articulated arm isextended or moved during a procedure.

• Inspect the UltraScan Encore optics by viewing them in a well-litlocation. The input and output optics in the handpiece bodyshould appear translucent, smooth, bright, and free of any cracks,spots, dirt, or obvious damage. If either lens appears dirty, clean asdescribed in this chapter.


0633-227-01, Revision C

• If the brightness of the aiming beam fluctuates greatly or if theaiming beam is not visible, the UltraScan Encore lenses may bedamaged or the laser articulated arm may be out of alignment; callyour local Lumenis service representative.

11. Repeat the beam alignment procedure. If the beam alignment is stillunacceptable, call your local Lumenis service representative.

12. Place the laser in standby mode until ready for use.

Inspect and Clean the UltraScan Encore

Before and after each use, inspect the delivery system components for dirt,debris, or damage. If assembled, disassemble and inspect the individualcomponents.

WARNINGAlways disconnect the delivery system from the laser be-fore inspection. Never look directly into the device whileit is connected to the laser. Accidental laser exposure cancause severe eye damage.

NOTEDo not touch any optical lens; finger oils may damage thedelicate coatings.

Clean the external surface of the delivery system

To clean the external surface, first disconnect the delivery system from thelaser. If appropriate, disassemble the device, and wipe using a cloth damp-ened with a noncaustic cleaning solution. Dry with a clean cloth.

NOTEDo not spray or pour cleaning agents directly on thedevice, and do not wipe the inside surface.

Inspect the UltraScan Encore optics

Inspect the UltraScan optics by viewing them in a well-lit location. Theinput and output optics in the handpiece body should appear translucent,but smooth, bright, and free of any cracks, dark spots, or any noticeabledirt, debris, or obvious damage.


0633-227-01, Revision C

Clean the UltraScan Encore optics

If the UltraScan optics appears dirty, clean as instructed below. ALumenis optics cleaning kit or the following cleaning supplies are re-quired:

• lens cleaning tissue—professional optical-quality (Kodak® or equiva-lent), not eyeglass-quality

• cotton-tipped applicators (Puritan® or equivalent non-glued tip ap-plicator)

• distilled water• one of the following reagent grade cleaning solutions: acetone, 100%

methanol, or 100% ethanol

CAUTIONDo not use any solutions other than those specified. Do-ing so may permanently damage the lens and adverselyalter the delivered laser power.

CAUTIONDo not disinfect or sterilize the optical lens. Doing so mayirreparably damage the instrument.

1. Soak several cotton-tipped applicators in distilled water and wrap eachapplicator in lens tissue.

2. Gently wipe the lens in one direction to remove tissue debris. Do notwipe in more than one direction; loosened particles or debris mayscratch the lens coating.

3. Repeat steps 1 and 2, except soak the wrapped applicators in reagentgrade acetone, 100% methanol, or 100% ethanol, instead of distilledwater.

4. If the lens is still not clean, repeat the cleaning procedure, alwaysusing new, clean lens tissues and cotton-tipped applicators. Do notreuse the lens tissues; loosened particles or debris may scratch the lenscoating. If the lens is still dirty or appears damaged, contact your localLumenis service representative.


0633-227-01, Revision C

Inspect the UltraScan Encore handpiece tip, handpiece tip inner tube, and spatula tip

After use, the inside of the handpiece tip, handpiece tip inner tube, andspatula tip should be inspected to ensure that they are clean of any residuallaser plume contamination or dirt.

Clean the UltraScan Encore handpiece tip, inner tube, and spatula tip

NOTEDo not place the handpiece tip in an ultrasonic cleaner.The finish on the handpiece tip will be damaged.

Clean the handpiece tip, inner tube, and spatula tip prior to reuse usingthe following technique:

1. Soak for five minutes in one gallon of hospital-grade enzymatic deter-gent, such as Enzol® or Cidezyme® (Johnson & Johnson®), preparedaccording to the instructions provided on the detergent container.

2. Soak a soft gauze in enzymatic detergent, and wipe clean.

3. Rinse in a brisk stream of clean tap water at 22°C - 43°C (71.6°F -109.4°F) sufficient to remove all residue and debris from both theinterior and exterior surfaces.

4. (For inner tube and spatula tip only.) Prepare an ultrasonic surgicaldetergent, such as Miltex® (Miltex), mixed according to the instruc-tions provided on the detergent container. Immerse and sonicate forfive minutes. (Do not place the handpiece tip in the ultrasoniccleaner.)

5. Rinse in a brisk stream of clean tap water at 22°C - 43°C (71.6°F -109.4°F) sufficient to remove all residue and debris from both theinterior and exterior surfaces.

6. Dry the exterior surface with a clean soft gauze.

7. Dry any inside surface with compressed air.

The handpiece tip, inner tube, and spatula tip are now ready for steriliza-tion.


0633-227-01, Revision C

CAUTIONDo not spray or pour disinfecting agents on the UltraScanEncore body, which contains optics and sensitive internalelectronic circuitry. Irreversible damage could occur if thedisinfecting agent comes into contact with any of the in-ternal surfaces or optics.

Sterilize the UltraScan Encore handpiece tip, handpiece tip inner tube,and spatula tips

The UltraScan Encore ships in a clean, non-sterile condition. Prior tosurgical use, steam sterilize the UltraScan Encore handpiece tip, handpiecetip inner tube, and spatula tips.

CAUTIONDo not sterilize the handpiece body. Sterilization mayirreparably damage the optics and internal electronic cir-cuitry.

Prevacuum Cycle4 minutes at 132°C (270°F)100% humidity

or

Gravity Displacement Cycle10 minutes at 132°C (270°F)

The components must be thoroughly dry, inside and out, before use.

Cool Down CycleAs desired


0633-227-01, Revision C

Specifications

Specifications subject to change without notice.

Physical characteristicsDelivery system length: 24.1 centimeters (9.5 inches)

Maximum laser input power and energyUp to 100 watts continuous (< 30 seconds)Up to 0.5 joule pulse energy (<2 milliseconds)

Compatible wavelengthsTreatment beam: 10.6 micrometers, 11.1 micrometersAiming beam: 630-650 nanometers

Spot SizeCollimated, 1.3 millimeters

Pattern Dimensions1.3 millimeters to 14.6 millimeters

Single Full Pattern Exposure Duration<1 second

Laser Power Transmission>80% of treatment beam

Laser System CompatibilityUltraPulse Encore CO

2 surgical lasers

Laser Safety EyewearCarbon dioxide laser wavelengths; laser safety eyewear that meets theoptical density requirements as detailed in the "Laser Safety Eyewear"section of this manual.

Smoke Evacuation Tubing22 millimeter (7/8 inch) inner diameter


0633-227-01, Revision C

Warranty Information

For specific and detailed warranty information for this instrument, pleaserefer to the first page of your purchase “Agreement” and the last page ofthe “Terms and Conditions of Sale.”

Decontamination of Returned Equipment

To comply with United States postal and transportation law, equipmentshipped to Lumenis US offices for repair or return must be properlydecontaminated with a chemical germicide that is commercially availableand cleared for use as a “Hospital Disinfectant.” To ensure that allequipment has been properly decontaminated, a signed DecontaminationCertificate (provided at the back of this manual) must be enclosed in thepackage, or Lumenis will assume that the product is contaminated andwill assess the customer with cleaning costs.

Any decontamination inquiries should be directed to the Lumenis USservice offices.


0633-227-01, Revision C


0633-227-01, Revision C

Users must take precautions to prevent exposure of laser energy to the eyesand skin from either direct or diffusely reflected laser beams, except as atherapeutic application. Additional precautions must be taken to preventfire, electrical injury, and explosion.

Lumenis does not make recommendations regarding the practice of medi-cine. Laser treatment parameters are provided as a guide. Individual treat-ment should be based on clinical training, clinical observation of laser-tissue interaction, and appropriate clinical endpoints.

Safety and Regulatory


0633-227-01, Revision C

Laser Safety Eyewear

Laser safety eyewear is routinely required with most lasers. When usingthe laser system, the Laser Safety Officer should determine the need forsafety eyewear based on the Maximum Permissible Exposure (MPE),Nominal Hazard Zone (NHZ), the Nominal Ocular Hazard Distance(NOHD), and the optical density (OD) for each of the available laseremissions and the configuration of the treatment room (usually within thecontrolled area). For additional information, refer to ANSI Z136.1-1993,ANSI Z136.3-1996, or European Standard EN 60825: 1992,Appendix A.

The following formula was used to calculate the worst case NOHD forLumenis UltraPulse Encore lasers and compatible delivery systems. There-fore, the values specified here meet or exceed the laser safety eyewearrequirements for the UltraScan Encore CPG delivery system.

NOHD =1θ

4π

ΦMPE Pf - a2Z +

where,

Z = the distance of the beam waist from the laser system;a = the beam waist diameter (1/e2 of axial irradiance for gaussian

beam);θ = minimum full angle beam divergence (1/e2 of axial irradiance

for gaussian beam);e ≈ 2.7182818285, the base of natural logarithms;Φ = maximum energy of one laser pulse or maximum CW laser

power;Pf = the profile correction factor (1 for uniform profile or 2 for

gaussian irradiance profile;MPE = Maximum Permissible Exposure, in energy density units (en-

ergy per unit area), or power density units (power per unitarea);

NOHD = the Nominal Ocular Hazard Distance (measured from laseraperture);

= the distance required to reduce the energy density or powerdensity to the MPE.


0633-227-01, Revision C

a

θ

ZNOHD =

1θ

4π

ΦMPE Pf - a2Z +

Using this approach we derive the following values:

which results in a worst case NOHD of :

All personnel who are within the NOHD are considered to be within thecontrolled area and shall wear eye protection with a minimum opticaldensity (OD) of:

Laser system

UltraPulse Encore .00224 60W 0.1 W/cm2 2 0.6 cm 1.0 cm

Laser system θ Φ θ Φ θ Φ θ Φ θ Φ MPE Pf a Z

UltraPulse Encore 175 meters

NOHD

UltraPulse Encore 4.88

OD

Laser system

Laser system


0633-227-01, Revision C

Laser safety eyewear must also be resistant to physical damage or pho-tobleaching resulting from laser exposure as per ANSI Z136.1-1993, sec-tion 4.6.2 and Appendix C. For users who must comply with EN 207, thesafety eyewear must have a protection class of L4.

In addition to providing the required laser safety eyewear, take the follow-ing steps to secure the treatment room, or the controlled area:

1. To alert personnel before they enter the controlled area, place a warn-ing sign on the outside of the treatment room door when the laser is inuse.

2. Close the treatment room door during operation of the laser.

3. External door interlocks that automatically disable the laser when thetreatment room door is opened may be installed.

NOTEA blocking barrier, screen, or curtain capable of blockingor filtering the laser beam could be placed to create acontrolled area inside a large treatment room. The barriershould be made of material that can withstand the powerof the treatment beam for the maximum exposure time,relative to the configuration of the controlled area and thetreatment parameters for the specific medical application.

Depending on the procedure, the physician must protect the patient’s eyeswith either laser safety eyewear or one of the following items moistenedwith a nonflammable solution: thick cloth, eye pads, or gauze 4 x 4’s. Forperiorbital treatment, the physician must protect the patient with dulled,metal eye shields.


0633-227-01, Revision C

Additional Ocular Protection

WARNINGAlways verify that the delivery device is properly con-nected to the laser. An improper connection may result inan inadvertent secondary laser beam. Severe eye or tissuedamage could occur.

WARNINGNever substitute prescription eyewear for the appropriatelaser safety eyewear, as severe eye damage could occur.Prescription eyewear can concentrate the laser light to theeye and/or can be shattered by a high power density beam,possibly causing severe eye damage.

WARNINGUse caution when performing procedures around the eyes.Severe and irreversible eye damage and scarring may occurfrom direct or indirect exposure to the treatment beam.The predominant ocular structures at risk are dependenton the laser wavelength in use. In general, visible and near-infrared wavelengths are most damaging to the retina,while ultraviolet or infrared wavelengths are most damag-ing to the cornea and sclera. Severity of injury depends onhow concentrated or diffused the treatment beam is andthe length of exposure. A thorough understanding of thespecific ocular risks and safety precautions for each laserwavelength is necessary to ensure the safety of the patientand operating personnel.

WARNINGNever look directly into any optical lens, optical fiber,handpiece, probe, laser articulated arm, or laser systemaperture while the laser is energized. Severe eye damagecould occur. Turn off the laser before inspecting any deliv-ery system or laser components.


0633-227-01, Revision C

Additional Safety Considerations

WARNINGDo not use this device in the presence of flammables orexplosives, such as volatile anesthetics, alcohol, certain sur-gical preparation solutions, and similar substances. An ex-plosion and/or fire could occur.

WARNINGSpot size and laser energy are independently controlled. Ifthe user changes to a delivery system with a smaller spotduring a procedure, the user must remember that the en-ergy or power density will increase.

CAUTIONLaser plume may contain viable tissue particulates.

CAUTIONThe laser plume obscures the operative field and is noxiousto those who come into contact with it. The plume pre-sents a possible biologic and pollution hazard and shouldbe effectively evacuated.

CAUTIONPlastic instrumentation such as speculums or eye shieldsmay melt when impacted by the laser beam, possibly re-sulting in chemical burns or noxious gases. Therefore,only laserized stainless steel surgical instruments should beused.

CAUTIONCarbon dioxide light can be reflected off of smooth metal-lic surfaces, even though they may be blackened.

CAUTIONUS federal law restricts this device to sale by or on theorder of a physician.

CAUTIONLumenis medical lasers and laser delivery systems are in-tended solely for physicians trained in the use of theseinstruments.


0633-227-01, Revision C

CAUTIONUse of controls or adjustments or performance of proce-dures other than those specified herein may result in haz-ardous laser radiation exposure.

Fire hazards

Operating room personnel should be aware of the following safety consid-erations and potential fire hazards when using a surgical CO

2 laser:

• A CO2 laser beam can ignite most nonmetallic materials.

• Use fire-retardant drapes and gowns.• A UL-approved fire extinguisher and water should be readily available.

WARNINGDo not use this device in the presence of flammables orexplosives, such as volatile anesthetics, alcohol, certain sur-gical preparation solutions, and similar substances. An ex-plosion and/or fire could occur.

WARNINGThe area around the target site can be protected with wettowels or gauze sponges. If allowed to dry, these protectivetowels and sponges can increase the potential fire hazard.

WARNINGLaser treatment of adipose tissue may cause cellular fat toliquefy and accumulate into lipid pools. Pooled lipids areflammable and can be ignited by laser radiation, resultingin fire and potential patient injury.

Nontarget tissues may be protected in a variety of ways

• Saline soaked gauze sponges, moistened cotton-tipped applicators, ortitanium rods may be used as backstops for the laser beam.

• Patients’ lips can be protected by moist gauze. When operating in theoral cavity, care should be taken to protect teeth and bone by usingwet gauze or other nonflammable, heat-absorbing protective material.

• When anesthesia or pain medication are not used, the comfort andpain tolerance of the patient must be assessed. Unexpected movementby the patient could result in laser exposure to unintended tissue.


0633-227-01, Revision C

Regulatory Compliance

Lumenis lasers and delivery systems comply with 21 CFR Chapter I,Subchapter J, as administered by the Center for Devices and RadiologicalHealth of the US Food and Drug Administration (FDA).

CE-labeled devices comply with all appropriate performance standards asspecified in Annex II of the European Medical Device Directive MDD93/42/EEC.

NOTEThis package conforms to the conditions and limitationsspecified in US federal regulations, title 49 CFR 173.426for radioactive material, excepted package-articles manu-factured from natural thorium, UN 2910.

Location of regulatory and other system labels

As required by national and international regulatory agencies, appropriatelabels have been mounted in specified locations.

93/42/EEC0086

0628-319-01 rC

SN

REF

USV1356

0633-227-01

05/00

Location of regulatory compliance labels


0633-227-01, Revision C

Indications for Use

This delivery system is indicated for a variety of surgical uses including,but not limited to, ablation, coagulation, incision, excision, and vaporiza-tion of soft tissue. This device may be used in the medical specialties orprocedures for which the compatible laser has received regulatory clear-ance. Refer to the laser operator manual, Indications for Use section.


0633-227-01, Revision C

Decontamination Certificate

Under the provisions of Postal Law, Title 18, United States Code, Section 1716, andDepartment of Transportation regulations contained in CFR 49, Part 173.386 and 173.387,“etiologic agents, diagnostic specimens and biological products…are nonmailable…”

The undersigned therefore certifies that the Lumenis equipment being returned herein by

_________________________________ __________________________________Individual/Institution City, State, Country

has undergone decontamination with a commercially available germicide cleared for use asa “Hospital Disinfectant” and is clean and free from biohazards, including - but not limitedto - human or animal blood, tissue or tissue fluids or components thereof.

The undersigned also agrees to reimburse Lumenis for any costs incurred in cleaning theenclosed equipment, in the event said item(s) is/are received by Lumenis in a contaminatedcondition.

_________________________________ __________________________________Model Model

_________________________________ __________________________________Serial Number (if applicable) Serial Number (if applicable)

_________________________________ __________________________________Lumenis RMR Number Lumenis RMR Number

_________________________________ __________________________________Typed/Printed Name Position/Title

_________________________________ __________________________________Signature Date

Documents

CO2 Computer Pattern Generator (CPG) Operator Manual · System beeps 17 Turn on the pattern generator 17 Select the pattern number (pattern shape) 18 Select the pattern size 19