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NATIONAL BIOLOGICAL DERMALUME 2X Operation Manual

Phototherapy devices with narrowband uvb lamps
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Operations
Manual
Phototherapy Devices
with Narrowband UVB Lamps
999-200 Rev 018
1

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  • Page 1 Operations Manual Phototherapy Devices with Narrowband UVB Lamps 999-200 Rev 018...
  • Page 2 Dear Valued Customer: Thank you for purchasing a National Biological Corporation ultraviolet light phototherapy device. The attention to design and care in manufacturing will ensure many years of reliable service. The instructions and guidelines presented in this manual are provided to aid in developing a treatment regimen for management of dermatological disorders.

  • Page 3: Table Of Contents

    General phototherapy guidelines ........... 13 Treatment guidelines for psoriasis ..........13 Treatment guidelines for vitiligo ..........14 ® Panosol 3D (8 and 10 lamp models) ..........16 Positioning your body ..............16 Treatment protocols ..............17 Replacing lamps ................. 19 Specifications ................
  • Page 4 DermaLume 2X ................46 Positioning your body ..............46 Treatment protocols ..............47 Replacing lamps ................. 49 Specifications ................49 ® Dermalight 90 ................50 Positioning your body ..............50 Treatment protocols ..............51 Replacing lamps ................. 53 Specifications ................53 Timer Operation ................

  • Page 5: Introduction

    Any use of the device except as prescribed by your physician may be hazardous. Such use may jeopardize the success of the therapy, cause health risk, and render the National Biological warranty null and void. The company shall not be liable for any damage caused by improper use of...
  • Page 6 THIS DEVICE IS TO BE USED BY PRESCRIPTION ONLY • Consult a physician before using any phototherapy device. • Exposure times should be established and increased only as directed by a physician. • Never expose more than once in 24-hours, unless otherwise directed by a physician.
  • Page 7 UV light. • Wear protective UV blocking eyewear (National Biological Part # 9PE-004) for the entire duration of the UV exposure. Failure to do so may result in long term injury to the eyes.

  • Page 8: Determining Your Skin Type

    ETERMINING YOUR Consult your physician to determine your Skin Type. Treatment times are based on Skin Type or Minimal Erythemal Dose (MED). Each person has an overall Skin Type but different areas of skin such as those rarely exposed to UV light may react as a lower skin type. The scalp is always treated as Skin Type I regardless of Skin Type.

  • Page 9: Power And Electrical Requirements

    OWER AND ELECTRICAL REQUIREMENTS For safe operation, this device must be connected to a dedicated, grounded 15 A circuit or a grounded 20 A branch circuit. All electrical connections to the device must be in compliance with the National Electrical Code (NFPA 70). WARNING! Improper use of a grounding (protective earth) plug can result in a risk of electric shock and will void the warranty.

  • Page 10: Cleaning And Maintenance

    LEANING AND MAINTENANCE This device will provide years of use with proper maintenance. It should be periodically checked for damage and cleaned. Lamps should be replaced at proper intervals for optimum treatment. Only use approved phototherapy lamps in this device. Unplug the device from the electrical outlet before cleaning or replacing lamps.

  • Page 11: Definitions And Symbols

    A brief description of the problem or reason for return e. Return authorization number that was provided 4. The external package label should be addressed as follows: National Biological Corporation 23700 Mercantile Road Beachwood, Ohio 44122 ATTN: Customer Service, REF: RA#_______ For any questions or general information about this or any other National Biological product, please contact Customer Service.
  • Page 12 WARNING SYMBOLS WARNING, GENERAL, RISK OF PERSONAL INJURY WARNING, HOT SURFACE WARNING, ELECTRICITY WARNING, NON-IONIZING RADIATION WARNING, LAMPS CONTAIN MERCURY WARNING, PINCH POINT TIP WARNING WARNING, ULTRAVIOLET RADIATION CAUTION, RISK OF DAMAGE TO MACHINERY, SOFTWARE OR PARTS NOTE OPERATING INSTRUCTIONS NO WASTE - UNIT CONTAINS ELECTRICAL AND ELECTRONIC EQUIPMENT THAT MUST BE DISPOSED OF AND/OR RECYCLED PROPERLY...

  • Page 13: General Phototherapy Guidelines

    GENERAL PHOTOTHERAPY GUIDELINES This manual contains sample guidelines, dosage, and treatment times for psoriasis and vitiligo that your physician may direct you to follow. Guidelines are intended to support physician recommendations; where different, physician recommendations supersede these recommendations. If phototherapy has been prescribed for any other dermatological disorder, consult your physician.

  • Page 14: Treatment Guidelines For Vitiligo

    Maintenance phase for psoriasis The goal of maintenance is to remain symptom-free for as long as possible with the least amount of exposure. Maintenance therapy begins when psoriasis is at least 95% clear (completely flattened plaque including borders, though plaque may still be outlined by pigmentation). There are two approaches to maintenance: stop treatments or continue treatments using a step-down approach such as shown in the chart below.
  • Page 15 Your physician will determine the initial treatment time, changes in treatment times, and frequency. It is important to carefully adhere to your treatment schedule. A Vitiligo Treatment Protocol that your physician may direct you to follow is provided in the section for your model. Treatment is most effective at 85 to 90% of the Minimal Erythemal Dosage (MED).

  • Page 16: Panosol 3D (8 And 10 Lamp Models)

    PANOSOL 3D ® (8 AND 10 LAMP MODELS) WARNING! Read safeguards, cautions, and warnings on pages 5 to 7 before use. OSITIONING YOUR BODY Stand 6 to 8 inches from the screen. Adjust the doors so that they are also 6 to 8 inches from your body.

  • Page 17: Treatment Protocols

    3 to 24 hours after last treatment. ® VITILIGO PROTOCOLS, PANOSOL 3D WITH 8 OR 10 LAMPS TREATMENT PROTOCOL Non-pigmented skin is always treated as Skin Type I 6”...
  • Page 18 PSORIASIS PROTOCOLS, PANOSOL ® WITH 8 OR 10 LAMPS 6” to 8” from screen Treatment distance INITIAL EXPOSURE Clearing phase treatments are typically 3 times per week. Skin Type Dosage (mJ/cm Time (min:sec) 0:43 1:13 1:27 1:50 1:57 2:13 EXPOSURE INCREASE SCHEDULE Clearing phase treatments are typically 3 times per week.

  • Page 19: Replacing Lamps

    EPLACING LAMPS Lamps should be replaced every 150-200 operating hours. While lamps may still light and appear normal, UV energy intensity decreases with use, making treatment less effective. Your timer keeps track of your lamp usage. To remove the screen, grasp near the center and pull straight up. Next, pull bottom of screen away from base and then down and away from device.

  • Page 20: Specifications

    PECIFICATIONS Specifications and replacement parts are in the following table. SPECIFICATIONS, 8-LAMP PANOSOL 3D® Power supply and consumptions 120 VAC / 60 Hz / 8A UV energy intensity Up to 3.0 mW/cm Number of pre-loaded treatments Maximum timer setting 10 minutes 78”...

  • Page 21: Assembly

    SSEMBLY Note. The entire assembly process can be completed with the device resting on the box. Open box 1 of 2 containing the main panel. Remove lamp box and set aside. This contains the main panel lamps. Lift the side of the panel slightly and remove the accessories kit from underneath the panel.
  • Page 22 Attach the support feet Locate the right foot marked “R” in box 1 of 2. Long end With the long end pointing up Long end (see middle photo), slide the foot into the right channel. Attach using 2 screws and the enclosed Allen wrench Short end Short end...
  • Page 23 The seated fitting is shown in the picture on the right. Stand device up and remove packaging Lock the casters on the feet. Carefully stand the device upright. It is recommended that you have two people to do so. Do not let go of the device until it is standing firmly on its support feet.
  • Page 24 Carefully peel away and discard the blue film from the reflector. This will pull up the “Remove Film Before Use” labels as well. You should see the bare reflector surface now.
  • Page 25 Install lamps from the lamp box that was set aside, and then reinstall the screen (see page 19). Remove the foam spacer near the hinge and remove the screen from each door (see page 19). Remove the rubber shipping rings from the top of the lamps.

  • Page 26: Panosol Ii ® (6 And 8 Lamp Models)

    ® PANOSOL II (6 AND 8 LAMP MODELS) WARNING! Read safeguards, cautions, and warnings on pages 5 to 7 before use. OSITIONING YOUR BODY Proper body positioning phototherapy is extremely important to ensure optimum effectiveness of the treatment. Stand with area to be treated approximately 6 to 8 inches 2’...

  • Page 27: Treatment Protocols

    REATMENT PROTOCOLS Review the general phototherapy guidelines on pages 13 to 15. The following tables provide specific treatment times and schedules for psoriasis and vitiligo based on these guidelines. To assess if erythema has occurred (as referenced in the tables below), look for redness of the healthy skin surrounding treated lesions to appear from 3 to 24 hours after last treatment.
  • Page 28 PSORIASIS PROTOCOLS, ® PANOSOL II WITH 6 OR 8 LAMPS 6” to 8” from screen Treatment distance INITIAL EXPOSURE Clearing phase treatments are typically 3 times per week. Skin Type Dosage (mJ/cm Time (min:sec) 0:43 1:13 1:27 1:50 1:57 2:13 EXPOSURE INCREASE SCHEDULE Clearing phase treatments are typically 3 times per week.

  • Page 29: Replacing Lamps

    EPLACING LAMPS Lamps should be replaced every 150-200 operating hours. While lamps may still light and appear normal, intensity decreases with use, UV energy making treatment less effective. Your timer keeps track of your lamp usage. To remove the screen, grasp near the center and pull straight up. Next, pull bottom of screen away from base and then down and away from device.

  • Page 30: Specifications

    PECIFICATIONS Specifications and replacement parts are in the following tables. SPECIFICATIONS, 6’ PANOSOL II ® WITH 6 LAMPS Power supply and consumptions 120 VAC / 60 Hz / 5 A UV energy intensity Up to 3.0 mW/cm Number of pre-loaded treatments Maximum timer setting 10 minutes 78”...
  • Page 31 Lift the side of the panel slightly and remove the accessories kit. Gently remove all foam packaging. Lift the bottom of the panel and slide it down so that it rests on the carton (top photo). Long end Remove the plastic bag from the panel but do not remove the bubble wrap.

  • Page 32: (4 Lamp Models)

    ® PANOSOL II (4 LAMP MODELS) WARNING! Read safeguards, cautions, and warnings on pages 5 to 7 before use. OSITIONING YOUR BODY Proper body positioning for phototherapy extremely important to ensure optimum effectiveness of the treatment. Stand with area to be treated 2’...

  • Page 33: Treatment Protocols

    REATMENT PROTOCOLS Review the general phototherapy guidelines on pages 13 to 15. The following tables provide specific treatment times and schedules for psoriasis and vitiligo based on these guidelines. To assess if erythema has occurred (as referenced in the tables below), look for redness of the healthy skin surrounding treated lesions to appear from 3 to 24 hours after last treatment.
  • Page 34 PSORIASIS PROTOCOLS, ® PANOSOL II WITH 4 LAMPS 6” to 8” from screen Treatment distance INITIAL EXPOSURE Clearing phase treatments are typically 3 times per week. Skin Type Dosage (mJ/cm Time (min:sec) 0:52 1:28 1:44 2:12 2:20 2:40 EXPOSURE INCREASE SCHEDULE Clearing phase treatments are typically 3 times per week.

  • Page 35: Replacing Lamps

    EPLACING LAMPS Lamps should be replaced every 150-200 operating hours. While lamps may still light and appear normal, UV energy intensity decreases with use, making treatment less effective. Your timer keeps track of your lamp usage. To remove the screen, grasp near the center and pull straight up. Next, pull bottom of screen away from base and then down and away from device.

  • Page 36: Specifications

    PECIFICATIONS Specifications and replacement parts are in the following tables. SPECIFICATIONS, 6’ PANOSOL II ® WITH 4 LAMPS Power supply and consumptions 120 VAC / 60 Hz / 3 A UV energy intensity Up to 2.5 mW/cm Number of pre-loaded treatments Maximum timer setting 10 minutes 78”...
  • Page 37 Lift the side of the panel slightly and remove the accessories kit. Gently remove all foam packaging. Lift the bottom of the panel and slide it down so that it rests on the carton (top photo). Long end Remove the plastic bag from the panel but do not remove the bubble wrap.

  • Page 38: Handisol Ii

    HANDISOL II ® WARNING! Read safeguards, cautions, and warnings on pages 5 to 7 before use. ® The Handisol II is portable and can be placed on the floor or on a table. It can be used vertically against a wall, horizontally, or angled by placing the handle underneath the device.

  • Page 39: Treatment Protocols

    REATMENT PROTOCOLS Review the general phototherapy guidelines on pages 13 to 15. The following tables provide specific treatment times and schedules for psoriasis and vitiligo based on these guidelines. To assess if erythema has occurred (as referenced in the tables below), look for redness of the healthy skin surrounding treated lesions to appear from 3 to 24 hours after last treatment.
  • Page 40 ® PSORIASIS PROTOCOLS, HANDISOL II Treatment distance At surface of shield INITIAL EXPOSURE Clearing phase treatments are typically 3 times per week. Time (min:sec) Skin Dosage Body 6-8” from Hands/feet on Type (mJ/cm shield device 0:22 0:27 0:37 0:46 0:43 0:54 0:55 0:69...

  • Page 41: Replacing Lamps

    EPLACING LAMPS Lamps should be replaced every 150-200 operating hours. While lamps may still light and appear normal, intensity decreases UV energy with use, making treatment less effective. Your timer keeps track of your lamp usage. WARNING! It is recommended that all lamps be replaced at the same time.

  • Page 42: Hand/Foot Ii

    HAND/FOOT II WARNING! Read safeguards, cautions, and warnings on pages 5 to 7 before use. Two Hand/Foot II devices are shown at right along with the optional cart. The shelves of the optional cart are at optimum height to comfortably treat hands and feet. OSITIONING YOUR BODY Proper body positioning for phototherapy is extremely important to ensure optimum...

  • Page 43: Treatment Protocols

    REATMENT PROTOCOLS Review the general phototherapy guidelines on pages 13 to 15. The following tables provide specific treatment times and schedules for psoriasis and vitiligo based on these guidelines. To assess if erythema has occurred (as referenced in the tables below), look for redness of the healthy skin surrounding treated lesions to appear from 3 to 24 hours after last treatment.
  • Page 44 PSORIASIS PROTOCOLS, HAND/FOOT II Treatment distance At surface of inner shield INITIAL EXPOSURE Clearing phase treatments are typically 3 times per week. Skin Type Dosage (mJ/cm Time (min:sec) 0:29 0:49 0:58 1:13 1:18 1:29 EXPOSURE INCREASE SCHEDULE Clearing phase treatments are typically 3 times per week. Erythemal Response Adjustments If you are:...

  • Page 45: Replacing Lamps

    EPLACING LAMPS Lamps should be replaced every 150-200 operating hours. While lamps may still light and appear normal, intensity decreases with use, UV energy making treatment less effective. Your timer keeps track of your lamp usage. WARNING! It is recommended that all lamps be replaced at the same time.

  • Page 46: Dermalume 2X Tm

    DERMALUME 2X WARNING! Read safeguards, cautions, and warnings on pages 5 to 7 before use. The DermaLume 2X is shown in the upper photo. The wand has three locking positions (see middle photo). Unfold the device to the position that will be most comfortable to hold for several minutes.

  • Page 47: Treatment Protocols

    To avoid dropping or breakage, place the Comb as distance guide device on a stable surface between treatments in a series. Between uses, store the device in its case. REATMENT PROTOCOLS Review the general phototherapy guidelines on pages 13 to 15. The following tables provide specific treatment times and schedules for psoriasis and vitiligo based on these guidelines.
  • Page 48 PSORIASIS PROTOCOLS, DERMALUME 2X Treatment distance At end of comb INITIAL EXPOSURE Clearing phase treatments are typically 3 times per week. Skin Type Time (min:sec) Dosage (mJ/cm 0:26 0:44 0:52 1:06 1:10 1:20 EXPOSURE INCREASE SCHEDULE Clearing phase treatments are typically 3 times per week. Erythemal Response Adjustments...

  • Page 49: Replacing Lamps

    EPLACING LAMPS Lamps should be replaced every 100 operating hours. While lamps may still light and appear normal, intensity decreases with use, UV energy making treatment less effective. Your timer keeps track of your lamp usage. WARNING! It is recommended that all lamps be replaced at the same time.

  • Page 50: Dermalight ® 90

    DERMALIGHT ® WARNING! Read safeguards, cautions, and warnings on pages 5 to 7 before use. OSITIONING YOUR BODY Proper body positioning for phototherapy is extremely important to ensure optimum effectiveness of the treatment. Find a position in which you can remain still during your treatment.

  • Page 51: Treatment Protocols

    REATMENT PROTOCOLS Review the general phototherapy guidelines on pages 13 to 15. The following tables provide specific treatment times and schedules for psoriasis and vitiligo based on these guidelines. To assess if erythema has occurred (as referenced in the tables below), look for redness of the healthy skin surrounding treated lesions to appear from 3 to 24 hours after last treatment.
  • Page 52 ® PSORIASIS PROTOCOLS, DERMALIGHT Treatment distance At end of comb INITIAL EXPOSURE Clearing phase treatments are typically 3 times per week. Skin Type Dosage (mJ/cm Time (min:sec) 0:33 0:55 1:05 1:23 1:28 1:40 EXPOSURE INCREASE SCHEDULE Clearing phase treatments are typically 3 times per week. Erythemal Response Adjustments If you are:...

  • Page 53: Replacing Lamps

    TTACHING THE COMB The comb is attached by sliding the four rib guides through the slots on the device until the two lugs on the comb snap into position. With a gentle nudge, the comb can be unlocked and then slid off of the device. EPLACING LAMPS The lamp should be replaced every 100 operating hours.

  • Page 54: Timer Operation

    TIMER OPERATION Most National Biological phototherapy devices have an integrated ® Controlled Prescription Timer (CPT ). The CPT controls the lights on the device and allows you to track the number of treatments you have remaining so that you can work with your physician to add treatments to your therapy regimen as appropriate.

  • Page 55: Interrupting A Treatment

    Interrupting a treatment Generally, a treatment ends when the timer reaches zero. However, there are two methods to interrupt a treatment in progress. 1. Press the timer START/STOP button. The timer count down will stop and the UV lamps will turn off. To resume therapy, depress the timer START/STOP button;...

  • Page 56: Resetting The Treatment Refill Code

    Refill Code is either incorrect or it was not entered properly. Repeat the steps above. If the timer does not reset after a few tries, contact your physician or National Biological Customer Service. Checking effective lamp life Your CPT keeps track of the number of hours that your lamps have been in operation.

  • Page 57: Cpt Tm Timer 2

    IMER Timer 2 is shown to the right. Running a treatment To begin operation, insert key and turn clockwise to ON. The screen will momentarily display the Intro screen (second figure) followed by the Set Time Timer 2 screen (third figure). The Set Time screen will display “00:00”...

  • Page 58: Interrupting A Treatment

    Repeat these steps as prescribed for other areas of your body. After the series of treatments prescribed by your physician has been completed, take off the goggles. Remove the key and store it in a safe place to prevent unauthorized use. Interrupting a treatment WARNING: If treatment is interrupted, do not start treatment over or add more total time than prescribed.

  • Page 59: Monitoring Remaining Treatments

    Monitoring remaining treatments Your device requires you to periodically contact your physician to renew your prescription. The number of treatments remaining is displayed at the bottom of the Set Time screen. One treatment is subtracted each time the timer reaches zero, when a treatment is cancelled, or when power to the device is lost.

  • Page 60: Checking Effective Lamp Life

    Checking effective lamp life Your CPT keeps track of the number of hours that your lamps have been in operation. To view the Lamp Usage screen (see photo at right), turn the key to ON. As soon as the Intro screen appears, press and hold both the –...

  • Page 61: Troubleshooting

    Customer Service. A yellow Indicator next to “Call Contact your physician to issue a new Doctor When Flashing” Refill Code. See page 65. flashing. National Biological Customer Service: Phone - 800-338-5045 or 216-831-0600 Email - info@natbiocorp.com...

  • Page 62: Notes

    NOTES...

  • Page 63: Warranty

    National Biological will cover reasonable freight expenses in the continental United States to ship products covered under Warranty both to and from National Biological’s servicing center if the product fails during the first three months. If the product fails after three months during...
  • Page 64 In no case shall National Biological be liable for liable for incidental, indirect, consequential, special, or punitive damages (including lost profits or lost wages) even if National Biological has been advised of the possibility of such damages. In addition, National Biological’s total aggregate liability shall never be greater than the amount paid by the Purchaser for the device.

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