User Verification Guide Smoothbeam Delivery System

Candela Corporation 530 Boston Post Road Wayland, MA 01778-1886 Telephone (508) 358-7637 Toll Free (800) 733-8550 (Technical Assistance) Toll Free (800) 73-LASER (Customer Service) 8502-00 -0869Revision A June 2004

TABLE OF CONTENTS
This "User Verification Guide" applies to the following Smoothbeam Delivery Systems:

4 mm Delivery System 6 mm Delivery System

p/n 7122-00-2050 p/n 7122-00-3211

* Introduction * Test #1 - Beam Alignment for 4 mm & 6 mm Delivery Systems * Test #2 - Cryogen Alignment for 4 mm Delivery Systems * Test #3 - Cryogen Alignment for 6 mm Delivery Systems * Test #4 - Cryogen Air Bubble Detection for 4 mm & 6 mm Delivery Systems * Warnings and Precautions

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Introduction: The purpose of this "User Verification Guide" is to provide you with a series of simple tests that will assist you in determining that your Smoothbeam delivery systems are working optimally. In addition, a series of "warnings" have been included. Through these "warnings" you may obtain a better understanding of variables that may affect the durability and performance of the Smoothbeam Candela laser delivery systems. It is important that you carefully review and follow the procedures and instructions contained in this "User Verification Guide" and in the laser's operator manual, treatment guidelines, and related information. FAILURE TO USE THE LASER IN ACCORDANCE WITH SUCH PROCEDURES AND INSTRUCTIONS COULD RESULT IN SERIOUS INJURY TO THE OPERATOR, THE PATIENT AND/OR OTHERS, AS WELL AS DAMAGE TO THE LASER DELIVERY SYSTEM. The fact that your laser delivery system passes the applicable tests contained in this "User Verification Guide" does not guarantee that your laser delivery system is problem- free. Discontinue use of your laser delivery system if you still suspect a problem with your laser delivery system.

Overview of Tests: This guideline contains information regarding four (4) types of tests. There are three specific tests to be performed per handpiece. Each test should be performed for the indicated delivery systems at the beginning of each treatment day using the tests outlined in this manual. In addition, check the delivery system if there is any concern about the delivery system's performance or the delivery system has been dropped. Discontinue use of the delivery system if problems are noted in any of these tests or you suspect / observe other factors that may affect performance.

Note: Perform tests 1-3 for 6 mm handpiece (pages 5, 8, 9, and 10) and then for the 4 mm handpiece (pages 5, 6, 7, and 10). This will eliminate the need to switch back and forth between the 4 mm and the 6 mm handpieces while performing the procedure.

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Introduction (continued)

Test # 1 2

For Delivery Systems 4 mm & 6 mm 4 mm

Test Beam alignment Cryogen alignment Cryogen alignment Cryogen air bubble detection

Purpose Identify a misaligned distance gauge. Verify that the cryogen spray nozzle is properly aligned with the distance gauge ring. Verify the cryogen spray nozzle is properly aligned with the distance gauge ring. Check that air bubbles in the cryogen line are detected and the associated "fault" messages are displayed on the system.

6 mm

4 mm & 6 mm

WARNING PLEASE WEAR APPROPRIATE SAFETY GLASSES DURING THE TESTS You will need the following supplies to perform these tests:
Zap-It Laser Alignment paper part Number Z-48 Available from Zap-It Corporation, Andover, NH 03216, USA. Template (P/N 1301-00-8192) available from Candela Corporation.

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Test #1 Beam Alignment for 4 mm & 6 mm Delivery Systems

Purpose: This procedure is designed to help identify a misaligned distance gauge on your Smoothbeam 4 mm or 6 mm handpieces. Procedure 1. 2. 3. 4. 5. Make sure that the window in the handpiece is clean (to prevent interference with the laser beam) before performing this test. Warning: Put on appropriate laser safety glasses . Connect the delivery system to the laser. Select a fluence of 8 J/cm2 for the 4 mm delivery system or 6 J/cm2 for the 6 mm delivery system. Enter the Ready mode, insert the handpiece into the calibration port and calibrate the laser by depressing the footswitch as outlined in the Operators Manual When calibration is complete, change the DCD setting to 20 ms. Hold your finger on the Reduce DCD button for 4 seconds to enter Ablation Mode, 0 DCD. You will receive a message Entering Ablation Mode; select OK. Place the black ZAP-IT paper on a flat, hard surface. Holding the delivery system perpendicular to the paper and the distance gauge contact ring completely flat an the black side of the paper, deliver a laser pulse. The laser pulse will make a small round spot on the paper.

6. 7.

Sample Beam Patterns PASS PASS FAIL

Good Full
###################333333
Template

Bad Incomplete

Clipping
Results: Acceptable results: The laser spot should form a round circle within the 4 or 6 mm distance gauge. Use template (1301-00-8192) to ensure that the laser spot on the ZAP-IT is round and located within the 4 or 6 mm circle on the template. This ensures that the laser beam is aligned within the distance gauge. The laser spot does not have to fill the template. The template provides a visual reference for being round. Be sure to clean the window before proceeding with treatments. Unacceptable results: If the laser spot IS NOT a full circle and does not match the proper template, the distance gauge is clipping the laser beam. Replace the distance gauge and repeat the test. If the spot IS a full circle, discard the original distance gauge. If after repeating the test, the spot still IS NOT a full circle, contact Candela to return the entire delivery system. Smoothbeam replacement distance gauges and windows are listed below:

Warning: Be sure to clean the window before proceeding with treatments.

Distance Gauges: 6 mm: P/N 1301-00-7845 4 mm: P/N 1301-00-7737 Windows: P/N 8010-00-0080

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Test #2 Cryogen Alignment for 4 mm Delivery Systems

Purpose: The purpose of this test is to verify that the cryogen spray pattern is optimally located in the burn spot.

4 mm Smoothbeam Procedure:
1. 2. 3. Warning: Put on appropriate laser safety glasses . Install the 4 mm delivery system on the laser. Holding the handpiece, select a fluence of 10 J/cm2 and the DCD cryogen spray time of 60ms. Warning: Stay in Standby. While directing the handpiece in a safe direction, purge the cryogen approximately 5 times by nd depressing the Next Screen button, and pressing purge button on 2 screen. This will fill the cryogen line within the delivery system.

4.

NEXT Screen Button

5. 6. 7.

Insert the handpiece into the calport and change the DCD setting to 20ms. Enter Ready mode and calibrate the laser by depressing the footswitch. After calibration has been completed, remove the handpiece from the calport. Holding the distance gauge contact ring flat on the ZAP-IT paper, pulse once onto the black side of the ZAP-IT paper.

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Test #2 Cryogen Alignment for 4 mm Delivery Systems continued 4 mm Smoothbeam Procedure (continued): The following are examples of acceptable and unacceptable burn patterns. Observe where the dark area is in relation to the light area. The dark area should be near the middle of the circle rather than near the edge of the circle.
Note: If the dark area is not seen or is faint; reduce the fluence until the dark area is visible on the zap-it paper.

ACCEPTABLE BURN PATTERNS, examples

UNACCEPTABLE BURN PATTERNS, examples

Acceptable results:

No further action needed.

Unacceptable results: Repeat test If the result is still unacceptable, discontinue use of the delivery system and replace the delivery system by contacting Candela Technical Support.

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Test #3 Cryogen Alignment Test for the 6 mm Delivery System

Purpose: The purpose of this test is to verify that the cryogen spray pattern is optimally located in the burn spot.

6 mm Smoothbeam Procedure:
1. 2. 3. Warning: Put on appropriate laser safety glasses . Install the 6 mm delivery system and insert the handpiece into the calport. Holding the handpiece, select a fluence of 10 J/cm2 and the DCD cryogen spray time of 60 ms. Warning: Stay in Standby. While directing the handpiece in a safe direction, purge the cryogen approximately 5 times by depressing the Next Screen button, and pressing purge button on 2nd screen. This will fill the cryogen line within the delivery system.

4.

NEXT Screen Button

5. 6. 7.

Insert the handpiece into the calport and change the DCD setting to 20ms. Enter Ready mode and calibrate the laser by depressing the footswitch. After calibration has been completed, remove the handpiece from the calport. Holding the distance gauge contact ring flat on the ZAP-IT paper, pulse once onto the black side of the ZAP-IT paper.

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Test #3 Cryogen Alignment Test for the 6 mm Delivery System (continued) 6 mm Smoothbeam Procedure continued:
The following are examples of acceptable and unacceptable burn patterns. Observe where the dark area is in relation to the light area. The dark area should be near the middle of the circle rather than the near the edge of the circle.

ACCEPTABLE BURN PATTERNS, examples

Note: If the dark area is not seen or is faint; reduce the fluence until the dark area is visible on the zap-it paper.

UNACCEPTABLE BURN PATTERNS, examples

Acceptable results:

No further action needed.

Unacceptable results: Repeat test If the result is still unacceptable, discontinue use of the delivery system and replace the delivery system by contacting Candela Technical Support.

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Test #4 - 4 mm & 6 mm Cryogen Air Bubble Detection

Purpose: To ensure that that air bubbles in the cryogen line are detected and the associated fault messages are displayed on the system. Warning: This procedure must be done with each Smoothbeam handpiece delivery system in your possession. The subsystem being tested is inside of each delivery system, not in the laser system. Procedure 1. 2. 3. 4. Insure that the installed DCD canister is not empty. Warning: Put on appropriate laser safety glasses. Turn on the system and allow the WARM UP to complete. With the Electrical Connector installed, disconnect the Cryogen Connector (see Figure 1).

Cryogen Connector

Figure 1 - Delivery System Connections

5. 6. 7. 8. 9.

Set the DCD spray on the front panel to the highest setting (85 ms is typical). Set the FLUENCE to the lowest setting (this varies by spot size). Enter the Ready mode, and calibrate the laser by pressing on the footswitch. Remove the handpiece from the CALPORT and aim in direction away from personnel (such as the floor). Depress the footswitch to pulse laser continuously until a PURGE REQUIRED window box appears on the user screen and lasing ceases. This should happen, typically 20 pulses but could be as much as 50 pulses. Results Comments This particular handpiece passed the test This particular handpiece failed the test Action You may continue use of this handpiece Discontinue use of this handpiece and call Candela Tech Support at (508) 358-7637 ext. 336 or (800) 733-8550 ext. 336.

If PURGE REQUIRED occurs If PURGE REQUIRED does not occur.

10. Reconnect the Cryogen Connector (see Figure 1) to use the system, or repeat the test on other Smoothbeam handpiece delivery systems. 11. Depress purge until the line is refilled.

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Warnings and Precautions:

This section contains a series of warnings. Through these warnings you may obtain a better understanding of variables that may affect the durability and performance of Candela laser delivery systems.

Warnings Related to Delivery System

Warning: The fact that your laser delivery system passes the applicable tests contained in this User Verification Guide does not guarantee that your laser delivery system is problem-free. Discontinue use of your laser delivery system if you suspect a problem with your laser delivery system. Warning: Use of a delivery system/handpiece with problems could result in adverse effects such as burns, scarring (hyper-tropic and/or atrophic), and pigmentary changes (hyperpigmentation and/or hypo pigmentation. Do not use a dropped delivery system/handpiece until after testing. Dropping the delivery system can result in damage and can affect the life of the delivery system, calibration, cryogen spray alignment, or bubble sense detection resulting in possible patient burns. If the delivery system is dropped, the user tests must be performed again before further use. Note: The laser beam alignment can be altered by 1) dropping the delivery system/related component or 2) by the laser beam passing through a burn spot or pits on the optics. A laser beam that is altered or misdirected could result in heating, charring, and possible ignition of associated components along with possible user and patient burns. Purge faults could indicate an excessive heating problem. Do not use a handpiece if cryogen is not aligned with the delivered energy spot /aiming beam or the cryogen spray pattern is unusual. If this is noted, contact Candela Technical Support and discontinue use of the handpiece. Do not use a handpiece if cryogen is found to be leaking from the hand piece nozzle tip or a reduced cryogen flow is noted. Discontinue use until cause is determined and eliminated. Purge the lines in order to flush the valve. If problem persists, do not use. Contact Candela Technical Support.

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Warnings and Precautions:

Treatment related WARNINGS
Warning: Tilting the distance gauge can result in an elliptical energy spot versus a circular spot and affect the distribution pattern of the cryogen. The distance gauge must be held perpendicular to the treatment spot. Crescent burns on the patient may occur. Warning: Overlapping of treatment spot size areas may result in crescent and general patient burns. Warning: Failure to replace the cryogen canister when the replace canister message appears could result in patient burns. Each laser system has been programmed to track cryogen canister consumption. The canister will contain a reserve quantity of cryogen after the replace canister message appears. However, cryogen level and performance cannot be ensured after message appears and the canister reaches empty and use may result in patient burns and other adverse effects. Warning: Failure to keep fiber tips and slider optics free of dust and debris can lead to possible patient burns. Laser energy striking dust and debris on optics including fiber tips will damage them which could lead to possible patient burns. When components of the delivery system are not attached to the laser system, such as the proximal end connector, cover those to prevent dust and debris from collecting on optics and exposed fiber tips. Warning: Failure to keep distance gauges clean can lead to possible patient burns . Debris on the distance gauge contact ring may result in heating of the ring or in bright flashes of light from debris being burned as laser energy strikes it. This could lead to possible patient burns.

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Warnings and Precautions:

Treatment related WARNINGS continued
Warning: Failure to keep windows at optimum may result in patient burns. Follow products delivery system cleaning protocols. Replace/clean windows according to protocol sent with distance gauges. Warning: Failure to replace windows properly after cleaning can result in failure of the lens or window and may cause patient burns. Improper window insertion could result in lens or window failure and cause burns. When removing a window for cleaning, carefully note (1) the window surface that was exposed to debris and (2) the direction in which such window surface faces. When re inserting the window, ensure that the window surface that was exposed to debris faces the same direction as it did prior to removal.

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