LouseBuster. Operator s Manual

Transcription

1 LouseBuster Professional Head Lice Treatment System Models LB-3120 and LB-3240 Operator s Manual Manufacturer: Larada Sciences, Inc. 350 West 800 North, Suite 203 Salt Lake City, UT USA Toll Free: (USA and Canada) Tel: LB Rev 1 U.S. and International Patents Pending

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3 Table of Contents Contents Page Definition of symbols. 3 1 Introduction. 4 Description of the LouseBuster Device 4 Indications for Use 4 Contraindications 4 Warnings 4 Cautions 5 2 Instructions for Use: Device Installation and Operation. 8 Device Installation 9 Device Operation 10 Setting-Up and Using the Treatment Timer 12 3 Instructions for Use: Treatment Overview.. 14 How it works 14 Treatment Overview and Pattern 15 4 Instructions for Use: Treatment Procedure Pre-Treatment Preparation 16 Pre-Treatment Check List 19 Important Treatment Techniques 20 Treatment Procedure 24 Post-Treatment Instructions 30 5 Maintenance and Service Routine Maintenance 33 Cleaning 33 Service and Repair 34 Warranty 34 Troubleshooting 34 6 Specifications Electromagnetic Compatibility.. 37 Appendix I: Accessories and Replacement Parts.. 40 Appendix II: Consent for Treatment Form Larada Sciences, Inc. 2

4 Definition of Symbols The following symbols may appear on the LouseBuster device or its packaging: Symbol Definition Symbol Definition Over temperature warning; HIGH TEMP Temperature ready; TEMP READY, Ready Under temperature warning; LOW TEMP IP2 0 O Ingress Protection rating ON / OFF Alternating Current Blower alert Caution: Consult accompanying documents Caution: Hot Surface Type B applied parts Consult accompanying documents Protective Earth (Ground) Start; Begin SN REF Single Use Only / Do Not Reuse Manufacturer European Authorized Representative Serial Number Catalogue Number Batch Code Good, Correct Stop; Finish Bad, Incorrect Use By (1) Professional Head Lice Treatment Equipment for use to kill or remove head lice Larada Sciences, Inc. 3

5 1 Introduction Description of the LouseBuster System The LouseBuster Professional Head Lice Treatment System is a portable, electrically powered, reusable device used to direct controlled, heated airflow to kill or remove lice and lice eggs on the hair and scalp of individuals with head lice infestations. The system consists of an applicator, a flexible delivery hose, a Power Cord, and the LouseBuster Control Unit, which includes heating and air movement components and associated safety monitoring and temperature control circuitry. The detachable delivery hose channels flowing, heated air from the LouseBuster Control Unit to the single-use, disposable applicator. During treatments, the applicator is manually positioned by certified operators to systematically direct heated air to the entire scalp and hair roots of an infested individual. An accessory treatment timer is provided to help assure that all areas of the scalp receive consistent treatment. Indications for Use The LouseBuster is intended for use to kill or remove lice and lice eggs in the head hair of human adults and children 4 years of age and older. Contraindications The device is only to be used for treating lice infestations of human head hair. It is contraindicated for use to treat clients: under the age of 4; who cannot sense temperature or pain; who cannot communicate physical discomfort; with recent (within 6 months) radiation treatment of the head; with open head wounds, sores, or any visible skin/scalp condition at the treatment area; with cranial or facial implants; with hair that cannot be combed through or picked through with a standard comb DO NOT USE THIS DEVICE ON ANYONE WITH ANY OF THE ABOVE CONDITIONS. Warnings WARNING: Explosion hazard. Do not use in the presence of flammable or explosive substances. WARNING: This device generates heated airflow. Improper use may cause burns. Always follow the treatment procedure instructions for use Larada Sciences, Inc. 4

6 WARNING: Safe use of this device for performing multiple treatments of the same individual has not been demonstrated. WARNING: Safe use of this device has not been demonstrated for children under the age of 4 years old. WARNING: To reduce risk of electrical shock or device damage, use only on a properly grounded 120 V (240 V) power supply with a minimum 15 A (10 A) fuse or breaker. WARNING: Grounding reliability can only be achieved when this equipment is connected to an equivalent receptacle marked Hospital Only or Hospital Grade (Model LB-3120 only). WARNING: To reduce risk of thermal injury, do not use on clients who cannot sense temperature or pain or communicate physical discomfort. WARNING: Stop use of the device immediately if the client delivers a verbal or physical signal of discomfort. WARNING: To reduce risk of electrical shock or thermal injury, do not attempt to operate the device with the Air Filter Cover off or the Air Filter removed. WARNING: To reduce risk of electrical shock or thermal injury, do not open the Control Unit enclosure or insert fingers or objects inside the Control Unit at any time. WARNING: Do not immerse the Control Unit or Treatment Hose. Moisture will damage the components, and thermal or electrical injury may result. WARNING: Failure to treat the entire scalp or deliver heated air to each treatment position for at least 30 seconds may result in decreased effectiveness. Always assure that at least 30 seconds of heated air are delivered to each treatment position. WARNING: Interruptions from continuous treatment may result in decreased effectiveness. Cautions CAUTION: For use only by operators who have completed the required training and certification program. CAUTION: For indoor use only in rooms warmer than 68 F (20 C). CAUTION: Do not start or continue any treatment while the High Temp, Low Temp or Blower Alert indicator light is illuminated Larada Sciences, Inc. 5

7 CAUTION: For use only on clients with dry, untangled hair that can be easily combed or picked and whose scalp and hair are clean and free of hair and scalp treatment products, including conditioners, creams, gels, dressings, or oil- containing products. CAUTION: To reduce the possibility of cross-infestation with lice, it is recommended that operators wear protective hair and body coverings and bystanders stay at least 2 meters (6 feet) away from the client during treatments. CAUTION: To reduce the possibility of cross-infestation with lice, clean the immediate treatment area and surroundings after each treatment. CAUTION: Before initiating any treatment, ensure that clients remove all external hearing aids, headwear, and jewelry, especially earrings and necklaces. CAUTION: To reduce the possibility of thermal injury from hot surfaces, do not use without Treatment Hose, Applicator Base and Applicator Tip properly attached. CAUTION: The Applicator Tip is for single use only. Dispose of properly after use. CAUTION: Ensure that client, and client s parent / legal guardian, as appropriate, are informed that discomfort progressing to pain and burning of the scalp may result if client does not communicate their discomfort to operator when it is initially experienced. CAUTION: For use only with the attachments, accessories, and Power Cord supplied by Larada Sciences. CAUTION: Do not use a dripping wet cloth to clean the device. Moisture may seep into the electrical components and damage them. CAUTION: Use only approved agents to clean the Control Unit and Treatment Hose. Unapproved cleansers or solvents may damage the labels and other plastic parts. CAUTION: Do not attempt to move the Control Unit by directly pushing, pulling, or lifting on the Treatment Hose, Hose Port, Sensor Cable/Connector/Port, Wheels, or Power Cord. CAUTION: Some live lice and/or lice eggs may remain in the hair after a LouseBuster treatment. For cosmetic reasons and to help assure that all lice and eggs are removed from the hair and scalp after treatment, a complete comb-out with a louse comb is recommended. CAUTION: The LouseBuster device uses radio frequency (RF) energy for its internal functions only. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. If this equipment is used in non-industrial (e.g. domestic) environments, however, RF interference is possible Larada Sciences, Inc. 6

8 CAUTION: NEVER TREAT A CLIENT IF AN AUDIBLE ALARM IS SOUNDING STOP TREATMENT IMMEDIATELY IF AN AUDIBLE ALARM SOUNDS DURING TREATMENT. DO NOT BEGIN ANY TREATMENT IF AN AUDIBLE ALARM IS SOUNDING. CAUTION: THIS OPERATOR S MANUAL MUST BE REVIEWED AND UNDERSTOOD PRIOR TO PERFORMING YOUR FIRST TREATMENT. CAUTION: YOU MUST RECEIVE FORMAL TRAINING AND AN OPERATOR CERTIFICATION NUMBER PRIOR TO PERFORMING YOUR FIRST TREATMENT Larada Sciences, Inc. 7

9 2 Instructions for Use: Device Installation and Operation Each LouseBuster Professional Head Lice Treatment Equipment pack (LB3E) includes: 1 - Control Unit (LB-3120 or LB-3240), 1 - Power Cord (LBPC), 1 - Treatment Hose (LBTH), 1- Applicator Base (LBAB), 1- Treatment Timer (LBTT), 1- Treatment Timer Wrist Strap (LBTT-WS), 1- Operator s Manual (LB-OPM), 1 - Abbreviated Instructions Card (LB-AI). Applicator Kits (LBAK) are ordered and shipped separately. Figure 1: LouseBuster Device Installation 1 OPERATING STATUS PANEL 2 SENSOR PORT 3 SENSOR CONNECTOR 4 TREATMENT HOSE 5 HOSE PORT 6 SERIAL NUMBER LABEL 7 HOUR METER 8 POWER SWITCH 9 POWER CORD INLET Figure 2: LouseBuster Control Unit Back View 10 AIR FILTER COVER 2010 Larada Sciences, Inc. 8

10 Device Installation 1. Plug the removable Power Cord (not shown) into the Power Cord Inlet (Figure 2). CAUTION: For use only with the Power Cord supplied by Larada Sciences. 2. Firmly insert the detachable Treatment Hose into the Hose Port (Figure 1). 3. Align and plug the Sensor Connector into the Sensor Port (Figure 1). NOTE: The device will alarm and not operate correctly if the Treatment Hose or the Sensor Connector is not properly connected. 16 TREATMENT HOSE 17 APPLICATOR BASE 18 APPLICATOR TIP Figure 3A: Applicator Assembly Figure 3B: Applicator Assembly 4. Attach the reusable Applicator Base to the Treatment Hose (Figure 3A). 5. Prior to each use, attach a disposable Applicator Tip (supplied separately) to the Applicator Base (Figure 3A). Ensure that both snap tabs lock into position in the Applicator Base. When assembled (Figure 3B), the Applicator Tip and Applicator Base are collectively called the Applicator Assembly or just the applicator Larada Sciences, Inc. 9

11 NOTE: For operator comfort, the Applicator Assembly can be rotated on the hose as shown in Figure 3B. CAUTION: The Applicator Tip is for single use only. Dispose of properly after use. 6. With the Power Switch in the OFF position, plug the Power Cord into a properly grounded power supply outlet. 11 OPERATING STATUS PANEL 12 BLOWER ALERT: AMBER LIGHT 13 HIGH TEMP: RED LIGHT 14 READY: GREEN LIGHT 15 LOW TEMP: BLUE LIGHT Figure 4: Operating Status Panel - Top View Device Operation 1. Turn the Power Switch ON (Figure 2). The blue LOW TEMP indicator light will illuminate on the Operating Status Panel. 2. With the power turned ON, the Control Unit will require a few minutes to warm up and reach the factory pre-set operating temperature. The warm-up time needed will depend on the air temperature of the room. CAUTION: For indoor use only in rooms warmer than 68 F (20 C). 3. During warm-up, a blue-colored LOW TEMP indicator light will illuminate on the Operating Status Panel (Fig. 4). A medium-speed audible alert will also sound to indicate the temperature is too low to perform a treatment Larada Sciences, Inc. 10

12 NOTE: The LOW TEMP light and alert will turn on anytime the temperature falls below the pre-set low temperature operating limit. CAUTION: Do not begin or continue any treatment while the LOW TEMP indicator light or alert is on. 4. When the device is at the proper temperature and ready for use, the green-colored TEMP READY light will illuminate on the Operating Status Panel and the audible alert will turn off. 5. If the temperature exceeds the pre-set high temperature operating limit at any time, the red colored HIGH TEMP indicator light will illuminate on the Operating Status Panel, a fast audible alarm will sound, and power to the heater will be automatically reduced or turned off until the temperature returns to normal. The HIGH TEMP light and alarm indicate the temperature is too high to perform a treatment. It may be necessary to turn the unit off and then on again to restore power to the heater. CAUTION: Do not begin or continue any treatment while the HIGH TEMP indicator light or alarm is on. 6. If during use the airflow falls outside of the factory pre-set range for acceptable flow rate, the amber-colored BLOWER ALERT indicator light will illuminate on the Operating Status Panel and a medium-speed audible alert will sound. CAUTION: Do not begin or continue any treatment while the BLOWER ALERT indicator light or alert is on. 7. If after warm-up the sensor cable is unplugged or a temperature sensor fails, the blue LOW TEMP and the red HIGH TEMP indicators will both light and a slow-speed audible alert will sound. In order to clear the alert and resume using the device, the Control Unit must be turned off and then on again. 8. If anytime during use an electromagnetic compatibility (EMC) phenomenon occurs, the device may alarm and automatically turn off power to the heater. This is a normal and safe device response. Stop treatment during any alarm. Resume treatment only when the operating temperature is reached as indicated by the green TEMP READY indicator light. In some cases, it may be may be necessary to turn the unit off and back on to clear the alarm. 9. For transport, lift the LouseBuster Control Unit by grasping the handles only. For movement during use, the system is intended to be rolled on the floor by pushing or pulling on the handles or the sides of the Control Unit only. CAUTION: Do not attempt to move the Control Unit by directly pushing, pulling, or lifting on the Treatment Hose, Hose Port, Sensor Cable/Connector/Port, Wheels, or Power Cord Larada Sciences, Inc. 11

13 SETTING UP THE TREATMENT TIMER: To help operators provide consistent treatments, a Treatment Timer and Treatment Timer Wrist Strap are provided with the LouseBuster device. The timer counts down in 1-second increments. Use the timer to assure each treatment position receives at least 30 seconds of airflow, regardless of interruptions. To begin count-down timing: Once the timer has been set, press the START STOP button (C) to begin the count-down. Once the timer reaches 00 M 00 S, an alarm will sound. Press the START STOP button (C) once to stop the alarm. The timer will simultaneously reset to 30 seconds as the alarm stops. To pause the timing during countdown, press the START STOP button (C). To resume the countdown, press the START STOP button (C) again. Using the timer during the treatment: Before starting, make sure that the timer has been set to 30 seconds. Place the applicator in the desired location on the client s head and immediately start the timer by pressing the START STOP button (C). Leave the applicator in position until 30 seconds has expired and the alarm sounds. Set the timer to count-down for 30 seconds: Press the second button (B) until the screen (D) reads 00 M 30 S (Note: the minute button (A) will not be used during a LouseBuster treatment). The timer will now be ready to begin a 30- second count-down. It also has a repeat memory function so the timer will not need to be reset after each use. Remove the applicator from the client s head. Press the START STOP button (C) to stop the alarm and reset the timer to 30 seconds. Reposition the applicator in the next treatment position and immediately press the START STOP button (C) to begin the next 30 second count down Larada Sciences, Inc. 12

14 Repeat this pattern for the entire treatment. Interrupting the treatment timing: of a turn counter-clockwise). Insert the battery with the positive (+) side facing up. Replace the battery cover. Whenever a client requests the treatment be paused: Immediately remove the applicator from the head of the client. Pause the Treatment Timer by pressing the START STOP button. Keep the applicator away from the client s head for 5-10 seconds. Place the applicator back on the head in the same position from which it was removed. Press the START STOP button on the timer to resume the countdown. Leave the applicator in position for the remainder of the 30 seconds unless the client asks for the treatment to be paused again, at which point repeat the above steps. When the countdown finishes, remove the applicator from the head and reset the count-down timer. Place the applicator in the next treatment position and start the next 30- second countdown. Replacing the Treatment Timer battery: An incorrect display, no display or operational difficulties indicate that the battery should be replaced. Use a coin to open the battery cover on the back of the timer (turn cover approximately 1/ Larada Sciences, Inc. 13

15 3 Instructions for Use: Treatment Overview The LouseBuster device is a medical product whose use is regulated by the US Food and Drug Administration and other agencies. The device is used for the treatment of head lice infestations. It is designed to deliver a large amount of heated air to a client s scalp and to the base of hair shafts where lice and their eggs are most frequently located. How it works Lice and lice eggs have high water content and they are accustomed to living in a protected and humid environment. Rapid exposure to large amounts of dry, heated air causes them to dry out and die. When lice and eggs are exposed to the right amount of heated air at the right temperature and for the right length of time, they die. For most of their lives, adult lice and newly hatched lice ( nymphs ) cling tightly to hair shafts, and they are usually located very close to the surface of the scalp. They cannot jump, fly, or swim, but they are relatively fast crawlers, and they typically move onto a new host via direct head-to-head contact. Lice and viable eggs are usually located very close to the surface of the scalp. Lice eggs are laid frequently by adults and glued very securely to a single hair shaft, usually very close to the scalp. Eggs cannot be removed with normal hair washing, and although they can be killed in place with the LouseBuster treatment, they cannot be blown off or vacuumed from hair shafts with air alone. NOTE: The term client is used in this manual to refer to the person receiving a LouseBuster treatment Larada Sciences, Inc. 14

16 Treatment Overview Each time a LouseBuster treatment is given, 4 main steps must be performed by the operator: 4 Important Steps for Every LouseBuster Treatment: Step 1: Prepare the device Step 2: Prepare the client Step 3: Perform the treatment Step 4: Clean-up Step 1 is described in Chapter 2, Device Installation and Operation. Step 2 is described in Chapter 4 under the section titled Pre-Treatment Preparation. Step 3 is illustrated and described in Chapter 4 under Treatment Procedure. Step 4 is described in Chapter 4 under the section titled Post-Treatment Instructions. Overview of the Treatment Pattern Each LouseBuster treatment is made up of 3 main treatment patterns: A. The Side-to-Side Pattern - - horizontal rows that start at the lower left hairline on the neck and move side to side and upward until reaching the top of the head. B. The Horseshoe Pattern - - a U or horseshoe shaped pattern on the top of the head. This pattern starts at the hairline on the forehead and moves around the midline and back to the hairline on the forehead. C. The Final Row Pattern - - a straight pattern along the midline of the head that progresses from the hairline at the forehead to the back or crown of the head. Treatment Pattern Summary 2010 Larada Sciences, Inc. 15

17 4 Instructions for Use: Treatment Procedure Pre-Treatment Preparation All of the following Pre-Treatment Instructions must be followed before beginning each LouseBuster treatment. Gather the materials needed to perform a treatment. These include: an assembled LouseBuster device with a new Applicator Tip; Abbreviated Instructions Card; Consent for Treatment Form; Patient Information Sheet; Certificate of Treatment Card; Proof of Authenticity Sticker; hair and body coverings for the Operator and a body covering for the client (required, but not provided); Hair clips (optional). 1. Operators should put on a head covering (typically a hair bonnet or cap) and a body covering (typically a lab coat or smock). Larada Sciences recommends disposable hair bonnets and re-usable lab coats (not supplied). CAUTION: To reduce the possibility of cross-infestation with lice, operators should wear protective hair and body coverings. 2. Carefully screen the client to confirm no contraindications are present and do not treat any client who: Is under the age of 4; cannot sense temperature or pain; cannot communicate physical discomfort; has had recent (within 6 months) radiation treatment of the head; has open head wounds, sores, or any visible skin/scalp condition at the treatment area; has cranial or facial implants; or has hair that cannot be combed through or picked through with a standard comb. If the client has ANY of the above contraindications, the client may NOT be treated with the LouseBuster device. NOTE: Clients should have been pre-screened for contraindications when scheduling the treatment. 3. Inform the client of possible risks of receiving a LouseBuster treatment, especially 1) the risk of burn, and 2) the risk of lice and/or lice eggs remaining in their hair after the treatment. Specifically inform them that: 1) CAUTION: Because the device uses heated air, there is a slight possibility of scalp burn if the device is not used correctly. This risk is well controlled by operator 2010 Larada Sciences, Inc. 16

18 technique and numerous safety features designed into the device. In clinical studies on over 500 subjects, no burns or other adverse events were reported, and the device is very safe when used according to instructions. 2) CAUTION: Some live lice and/or lice eggs may remain in the hair after a LouseBuster treatment. The LouseBuster device is very effective at killing or removing head lice and eggs. However, dead lice and dead eggs will remain in the hair after treatment. It is also possible that some lice or eggs may have been missed during the treatment. For cosmetic reasons, and to help assure that all lice and eggs are removed after treatment, a full comb-out with a lice comb is recommended. 4. Review the Consent for Treatment form with the client and have them or their parent / legal guardian read, complete and sign the form. Fill in the required information and treat this form as confidential information. 5. Invite the client to sit in the treatment chair. Gently fasten a treatment covering around the neck of the client (required). Adjust it to cover as much of their upper body and legs as possible. Explain that lice may fall out of their hair during the treatment, and the covering will help keep these lice off them. 6. Remind the client that their hair and scalp need to be clean and free of hair and scalp treatment products, including conditioners, creams, gels, dressings, and any products containing oils. Also, remind the client that their hair needs to be completely dry and free of tangles before the treatment can begin. (The client should have received these instructions when scheduling the treatment.) As necessary, gently use a pick or comb to completely de-tangle their hair. The heated air will not likely penetrate or be effective on braids, dreadlocks, corn rows, weaves, or other similar hairstyles that cannot be easily combed or picked. Treatment is not recommended for clients whose hair and scalp are not clean, dry, untangled, and free of hair and scalp treatment products. CAUTION: For use only on clients with dry, untangled hair that can be easily combed or picked and whose scalp and hair are clean and free of hair and scalp treatment products, including conditioners, creams, gels, dressings, or oil containing products. 7. Give the client an overview of what will happen during treatment: The applicator will be placed gently against their head and moved from one position to another following a set pattern until the whole head has been treated. This will take approximately 30 minutes. The applicator must stay in place for a minimum of 30 seconds in each position. Treatment air is heated, but is cooler than most hair dryers. You will let them know when there are only 15, 10, and 5 seconds remaining in each treatment position. 8. Tell the client what they should do during the treatment. The client: Should try to hold still, but is free to itch or scratch as needed Larada Sciences, Inc. 17

19 IMPORTANT: MUST tell you verbally and/or give a thumb down hand signal if the treatment becomes too uncomfortable at any time. Tell them if this happens, you will immediately remove the applicator from their head for a short time, and then you will resume treatment when the discomfort is gone. WARNING: Stop use of the device immediately if the client delivers a verbal or physical signal of discomfort. 9. Ask the client to remove any jewelry and accessories that may interfere with, or become hot during, the treatment. CAUTION: Before initiating any treatment, ensure that clients remove all external hearing aids, headwear, and jewelry, especially earrings and necklaces. 10. Before beginning a treatment, ensure that there are no people located within 2 meters (6 feet) of the client to be treated. CAUTION: To reduce the possibility of cross-infestation with lice, bystanders should stay at least 2 meters (6 feet) away from the client during treatments. 11. Put the Treatment Timer on your wrist and practice using it. It is best to have the timer on the same arm that you will use to deliver the treatment. Make sure the treatment timer has been set-up and is ready for countdown timing as described in Chapter 2. Practice starting, stopping, and resetting the timer, especially before your first few treatment sessions with the LouseBuster device. 12. Remove a single-use Applicator Tip from a treatment kit and attach it to the Applicator Base (Figure 3A). Make sure that both snap tabs lock securely into the Applicator Base. 13. Turn the device ON and allow the Control Unit to warm-up until the green TEMP READY light turns on and the audible alert turns off. Do not start the treatment until the alert has stopped and the green TEMP READY light is on. 14. Provide some video entertainment for the client during the treatment. A movie or video game may be relaxing for the client and help the time pass more quickly. This step is optional but recommended. CAUTION: THIS OPERATOR S MANUAL MUST BE REVIEWED AND UNDERSTOOD PRIOR TO PERFORMING YOUR FIRST TREATMENT. CAUTION: YOU MUST RECEIVE FORMAL TRAINING AND AN OPERATOR CERTIFICATION NUMBER PRIOR TO PERFORMING YOUR FIRST TREATMENT Larada Sciences, Inc. 18

20 Pre-Treatment Checklist For LouseBuster Treatments Please use this checklist prior to each LouseBuster treatment to ensure that all of the pre-treatment steps have been performed. 1. Operator wearing head and body covering. 2. Client screened for contraindications: NOT younger than 4 years of age CAN sense temperature and pain CAN communicate physical discomfort Has NOT had recent radiation treatment of the head Does NOT have open head wounds, sores, or skin/scalp conditions Does NOT have cranial or facial implants Has hair that CAN be combed or picked 3. Client informed of possible risks: Burns are possible but unlikely Lice or eggs may remain after treatment; comb-out recommended 4. Client Consent for Treatment form reviewed and signed. 5. Treatment covering placed on client. 6. Client s hair clean, dry, and untangled. 7. Treatment overview explained to client. 8. Client s responsibilities explained to them. 9. Client s jewelry and accessories removed. 10. Treatment area cleared of bystanders. 11. Treatment timer ready and practiced. 12. Single-use Applicator Tip attached. 13. Device turned ON, warmed up and Ready. 14. Video entertainment provided (optional). A separate laminated page with this check list is provided for your reference. Please keep it nearby or with the Control Unit and refer to it before each treatment Larada Sciences, Inc. 19

21 Important Treatment Techniques All lice and eggs must be exposed directly to the flowing, heated air for at least 30 seconds in order to be killed. Failure to direct controlled heated air to any portion of the scalp may result in lice surviving the treatment. Heated air must be directed at ALL areas of the scalp for at least 30 seconds. WARNING: Failure to treat the entire scalp, or failure to deliver heated air to each treatment position for at least 30 seconds, may result in decreased effectiveness. Always assure that at least 30 seconds of heated air are delivered to each treatment position. Hair is a very good insulator that can shield and protect lice from full effects of heat and airflow. IMPORTANT: Assure that the teeth of the applicator touch the scalp and that as much hair as possible is lifted up and away from the scalp during treatment. Minimize Hair Trapping. For clients with longer hair, lift the hair with one hand before placing the applicator against the scalp. This technique helps to prevent hair from being trapped under the applicator where it can mat down and protect lice and eggs from the full effect of the airflow. The best treatment results are achieved when you minimize hair trapped under the applicator. Hair trapped under applicator Hair lifted, not trapped Retain Heat and Airflow: For longer hair, position the hair over and around the applicator s air vents whenever possible so that the air is flowing directly toward the scalp under the hair. This will help to retain some of the heat and direct more of the airflow onto lice and eggs. For shorter hair, retain heat and direct more airflow downward by placing your hand at a downward angle a comfortable distance from the 2010 Larada Sciences, Inc. 20

22 applicator. The more heat and airflow that hits the lice and eggs, the better the treatment will be. Hair piled over and around applicator to retain heat, direct airflow to lice. Provide Good Position Overlap: When moving the applicator from one position to the next on each row, always be sure to overlap the previous position by one-half to twothirds. Make sure to also do this when moving from one row to the next row. Good position overlap ensures that all areas of the scalp are treated. It is a common error to not provide enough overlap between positions. Too much overlap is always better than not enough overlap. Poor overlap may result in an ineffective treatment. Perform a Full Treatment: On average, it takes approximately 30 minutes to deliver a typical LouseBuster treatment. Decreased time is typically needed to treat smaller heads, and increased time is typically required to treat larger heads. NOTE: The treatment is complete only after the entire treatment pattern has been performed. This may take more or less than 30 minutes. Do not stop the treatment at 30 minutes if the treatment pattern has not yet been completed. A treatment is complete ONLY after the entire treatment pattern has been performed. Complete the treatment in one continuous session, keeping interruptions to a minimum while assuring the safety and comfort of the client by directing the heated air away from the scalp whenever requested, whenever a device alarm sounds, or to address other safety concerns. Interruptions may decrease the treatment effectiveness and allow hatched lice to escape treatment by moving into previously treated areas. Once the treatment is initiated, continue to treat all positions, one after the other, interrupting the delivery of heated air only at the request of the client or to address any mechanical issues, device alarms, or safety concerns Larada Sciences, Inc. 21

23 WARNING: Interruptions from continuous treatment may result in decreased effectiveness. Treat the Hairline Boundaries: Be sure the entire outside boundary (or edge ) of the hairline is treated, especially for clients with very thick or curly hair. At every treatment position where a hairline boundary is encountered, make sure that one or two rows of the applicator fingers overlap the outside edge of the hairline (where there is no hair). Failure to treat the hairlines may result in an ineffective treatment. The applicator completely covers and overlaps the hairline boundaries. Protect the Eyes and Ears: For safety and comfort, do not direct heated air into the client s eyes or onto their ears. If needed when treating around the forehead or ears, use your hand as a shield to protect the eyes or ears from airflow. Touch the Scalp with Applicator Fingers: To correctly place the applicator for optimal effect, ensure that the tips or fingers of the applicator gently touch the client s scalp at each treatment position. Wiggle the applicator slightly while advancing it toward the scalp to help position or seat the curve of the applicator in the best spot for treatment. Do not press hard against the scalp! (This may be uncomfortable or painful for the client.) Wiggle the Applicator: Either rock the applicator a little from side-to-side or move it in very small circles. The tips of the applicator fingers can heat up during treatments, and moving the applicator slightly can help to reduce thermal discomfort for some clients and help break up any hair clumps that could potentially hide lice. Handling Interruptions: Occasionally, the client may ask that the applicator be removed from his/her head, or a device alarm may sound. In either case, immediately remove the applicator from the client s head. Be sure to stop the timer as the applicator 2010 Larada Sciences, Inc. 22

24 is removed and wait 5-10 seconds, or until the alarm ceases, before placing the applicator in the same position from which it was removed. Then restart the timer and resume treatment. WARNING: Failure to treat the entire scalp or deliver heated air to each treatment position for at least 30 seconds may result in decreased effectiveness. Always assure that at least 30 seconds of heated air are delivered to each treatment position. WARNING: Interruptions from continuous treatment may result in decreased effectiveness. Countdown the Time Out Loud: To help reduce client interruptions, try counting down the last 10 or 15 seconds out loud to the client. This coaching is especially helpful for clients who are sensitive to heat. Talking with the client may also reduce interruptions. Clip Up Excess Hair: With long hair, it may be helpful to clip up excess hair that is not within the immediate treatment area Larada Sciences, Inc. 23

25 TREATMENT PATTERN SUMMARY 2010 Larada Sciences, Inc. 24

26 STARTING POSITION AND FIRST ROW A - 1 HAIRLINE HEATED AIR EXITS UPWARD PLACE APPLICATOR AT STARTING POSITION Starting Position: With the airflow directed upward, place the applicator along the hairline just behind the left ear. The applicator should completely cover the left and bottom edges of the hairline as shown. DO THIS: Ensure the Applicator Tips gently touch the scalp. DO THIS: Minimize the amount of hair trapped under the applicator. A - 2 APPLY HEATED AIR FOR 30 SECONDS Start the timer and hold the applicator in position for 30 Seconds. When the timer beeps, remove the applicator from the scalp. NOTE: If the client indicates discomfort, pause the timer and remove the applicator. Wait 5-10 seconds, then reposition the applicator where it was and resume the timer countdown. DO THIS: Rock or move the applicator in small circles to help reduce client discomfort. A - 3 MOVE APPLICATOR TO NEXT POSITION OVERLAP EACH PREVIOUS POSITION BY AT LEAST HALF Reset the timer. Move the applicator to the right along the same row. Place the applicator gently against the scalp. Make sure the applicator covers the bottom edge of the hairline. NOTE: Each new treatment position should overlap the previous position by at least half. DO THIS: Place longer hair over the applicator. This will keep heated air at the base of the hair and scalp Larada Sciences, Inc. 25

27 A - 4 APPLY HEATED AIR FOR 30 SECONDS Start the timer and hold the applicator in position for 30 Seconds. When the timer beeps, remove the applicator from the scalp. As necessary for interruptions, pause the timer, remove the applicator from scalp for 5-10 seconds, and then resume the treatment and countdown. NOTE: To reduce interruptions, countdown the last 10 seconds out loud for the client. A - 5 CONTINUE AROUND HEAD, OVERLAPPING EACH POSITION BY AT LEAST HALF, TO ENDING POSITION BEHIND RIGHT EAR. Continue this step-and-repeat treatment pattern until you reach the hairline just behind the right ear. NOTE: The number of new positions in each row will vary with head size. END OF FIRST ROW STARTING A NEW ROW MOVE APPLICATOR UP TO START A NEW ROW. OVERLAP PREVIOUS ROW BY AT LEAST HALF. APPLY HEATED AIR FOR 30 SECONDS A - 6 Move the applicator up toward the top of the head so it overlaps the previous row by at least half. Make sure the applicator covers the hairline on the right side of the head. Treat this position as in previous steps. NOTE: Depending on head size, the starting and ending positions for each row may be slightly different than illustrated Larada Sciences, Inc. 26

28 A - 7 MOVE APPLICATOR TO NEXT POSITION APPLY HEATED AIR FOR 30 SECONDS Move the applicator to the left along the same row, overlapping the previous position and the previous row by at least half. Treat and move to the next position as before. A - 8 CONTINUE AROUND THE HEAD UNTIL REACHING THE FINAL POSITION FOR THIS ROW Continue this step-and-repeat treatment pattern to the left until you reach the hairline on the left side of the head. A - 9 MOVE APPLICATOR UP AND OVER TO BEGIN A NEW ROW. TREAT SCALP TO OTHER SIDE AS IN PREVIOUS STEPS. Start the next row by moving the applicator up and over to cover the left edge of the hairline. Remember to overlap the previous row by at least half. Continue to treat this row and subsequent rows using the same step-and-repeat pattern, moving by horizontal rows, all the way to the top of the head Larada Sciences, Inc. 27

29 THE TOP OF THE HEAD PLACE APPLICATOR ALONG MIDLINE AT FRONT EDGE OF HAIRLINE APPLY HEATED AIR FOR 30 SECONDS B - 10 When your horizontal rows have reached the midline at the top of the head, place the applicator next to the midline of the head and over the front hairline. Direct the airflow across the midline. NOTE: Depending on head size, the starting position for this pattern may be on the other side of the midline. DO THIS: Lift hair from the opposite side of the head over the applicator to help capture airflow and direct it down toward the scalp. B - 11 TREAT AROUND THE MIDDLE IN A HORSESHOE PATTERN. Perform the step-and-repeat treatment around the top of the head in a horseshoe shaped pattern. Make sure the airflow always blows across the midline to the opposite side of head. Overlap each previous position by at least half. B - 12 OVERLAP EACH PREVIOUS POSITION BY AT LEAST HALF UNTIL THE FRONT HAIRLINE IS REACHED. Continue to treat around the midline until you reach the front hairline again on the opposite side of the horseshoe Larada Sciences, Inc. 28

30 DOWN THE MIDLINE PLACE APPLICATOR AT HAIRLINE WITH HEATED AIR BLOWING TO BACK OF HEAD APPLY HEATED AIR FOR 30 SECONDS C - 13 The final treatment row occurs down the midline. With the airflow now directed away from the face, position the applicator over the front edge of the hairline and treat for 30 seconds. DO THIS: Hold hair from the sides or back of the head over the applicator to help capture airflow and direct it down toward the scalp. STEP AND REPEAT DOWN TOP OF HEAD C - 14 Continue the step-and-repeat treatment pattern down the midline until the top of the head has been treated. OVERLAP EACH PREVIOUS POSITION BY AT LEAST HALF ENDING POSITION MOVE APPLICATOR DOWN ROTATE APPLICATOR AND TREAT FINAL POSITION FOR 30 SECONDS C - 15 Ending Position: The final treatment position is just below the top or crown of the head. Overlapping the previous position by at least half, rotate the applicator so airflow is blowing upward and treat for 30 seconds. The treatment is now complete Larada Sciences, Inc. 29

31 Post-treatment Instructions After completing each LouseBuster treatment, the following steps should be taken: 1. Turn off the device; 2. Remove and dispose of the Applicator Tip; 3. Brush off and store the device; 4. Remove the client s treatment covering; 5. Check and remove your treatment coverings; 6. Clean the treatment area; 7. Provide the client with post-treatment instructions and Certificate of Treatment. 1. Turn off the device. On the back panel of the Control Unit, turn the Power Switch to the OFF position. 2. Remove and dispose of the Applicator Tip. After each treatment, remove the single-use Applicator Tip and dispose of properly in a covered waste receptacle to reduce the possibility of cross infestation. To remove the Applicator Tip, press in both snap tabs on the sides of the assembled applicator and pull the Applicator Tip away from the Applicator Base. 3. Brush off and store the device. Brush off the Control Unit, Treatment Hose and applicator to remove any lice that may have fallen out of the client s hair during treatment. Move the device out of the immediate treatment area. 4. Remove the client s treatment covering. Before you remove the client s treatment covering (usually a salon-style cape), remember that there may be lice and debris present that have collected during treatment. Gently brush off the covering to allow anything collected to fall onto the floor. Carefully remove the covering from the client and have them leave the immediate treatment area. If the client s covering is disposable, dispose of it in a covered waste receptacle. If the covering is re-usable, ensure it is free of any lice and debris, then fold and store. 5. Check and remove your treatment coverings. Before you remove your own hair and body treatment coverings (usually a hair bonnet and lab coat), remember that lice and debris may be present. To reduce the possibility of cross infestation from a client, all operators should check themselves carefully for lice after each treatment. Before removing your hair or body coverings, use a mirror or a second person to assure that no lice or debris have collected, especially around the shoulders, neck and edges of the hair covering. If your treatment coverings are disposable, carefully remove them and dispose of properly in a covered waste receptacle to reduce the possibility of cross-infestation. If 2010 Larada Sciences, Inc. 30

32 the coverings are re-usable, carefully remove them and gently brush them off to allow any collected debris to fall onto the floor, then fold and store them for the next treatment. Larada Sciences recommends using a louse comb at the end of each treatment day to detect any lice present. If lice are present, perform a comb-out or have one performed. 6. Clean the treatment area. It is common for lice, hair and other debris from a client s head to fall onto the floor during a treatment. To reduce the possibility of cross-infestation, clean the immediate treatment area and surroundings after each treatment has been completed. Larada Sciences recommends that the floor and all surfaces within and around the treatment area that could potentially hide or contain lice be carefully cleaned by vacuuming, sweeping, or another cleaning method. CAUTION: To reduce the possibility of cross-infestation with lice, clean the immediate treatment area and surroundings after each treatment. 7. Provide the client with post-treatment instructions. A) Not all lice and eggs may be dead after treatment. Inform the client that although the LouseBuster device effectively kills or removes lice and eggs, it is possible that some lice and/or eggs may have escaped treatment or may not have been killed during the treatment. If so, there may be living lice and/or viable eggs still present in the client s hair after the LouseBuster treatment. B) Not all lice and eggs may be removed during the treatment. Also inform the client that even though the LouseBuster treatment effectively kills and removes hatched lice and eggs, dead lice and dead eggs may remain in the hair after treatment. Lice eggs are particularly difficult to remove. In some places, children are required to be completely free of all hatched lice and lice eggs (also known as nits ) before they can be admitted into school, regardless of whether the lice and eggs are dead or alive. Even when a LouseBuster treatment kills 100% of the eggs, it is impossible to know by visual inspection whether lice eggs in hair are dead or alive. For cosmetic reasons, and to improve the likelihood that all lice and eggs are removed from the hair and scalp, Larada Sciences recommends that individuals either receive or perform a complete comb-out with a louse comb after the treatment. CAUTION: Some live lice and/or lice eggs may remain in the hair after a LouseBuster treatment. For cosmetic reasons and to help assure that all lice and eggs are removed from the hair and scalp after treatment, a complete combout with a louse comb is recommended. C) Give each treated client or their parent / legal guardian the Patient Information Sheet Larada Sciences, Inc. 31

33 D) Affix a Proof of Authenticity sticker on the Certificate of Treatment card, fill in the required information, and provide to the treated client or their parent / legal guardian Larada Sciences, Inc. 32

34 5 Maintenance and Service The LouseBuster device is designed for minimal care and maintenance under normal conditions of use. Routine Maintenance Only the Air Filter requires routine maintenance. Larada Sciences recommends replacing the Air Filter on the Control Unit every 400 treatments (or after approximately 200 hours of use as indicated by the Hour Meter on the back panel). The timing and need for Air Filter replacements may vary depending on the treatment environment. To replace the Air Filter, turn power OFF and disconnect the Power Cord from the Power Cord Inlet. Remove the 4 screws holding the Air Filter Cover and lift the Air Filter Cover off of the Control Unit (Figure 2). Remove the old Air Filter and replace it with a new Air Filter. Ensure the new Air Filter is properly seated in position and the air flow direction arrows shown on the filter are facing in toward the Control Unit. Replace the Air Filter Cover and screws as they were originally assembled. Tighten the screws snugly but not too tight; over-tightening the Air Filter Cover screws may crack the Air Filter Cover or damage the Control Unit enclosure. Always be sure to replace the Air Filter Cover after changing the filter. WARNING: To reduce risk of electrical shock or thermal injury, do not attempt to operate the device with the Air Filter Cover off or the Air Filter removed. Cleaning As needed or after every 10 treatments, clean the LouseBuster Control Unit, Treatment Hose, Hose fittings, and Applicator Base with a soft cloth and one of the following approved cleaning agents: Bleach-based Disinfecting Wipes or mild dishwashing soap. To prevent contact with hot surfaces, wait at least one hour after use before cleaning the device. WARNING: Do not immerse the Control Unit or Treatment Hose or hose fittings. Moisture will damage the components, and thermal or electrical injury may result. Do not attempt to clean the device when it is turned on or plugged into an electrical outlet. CAUTION: Do not use a dripping wet cloth to clean the device. Moisture may seep into the electrical components and damage them. CAUTION: Use only approved agents to clean the Control Unit and Treatment Hose. Unapproved cleansers or solvents may damage the labels and other plastic parts Larada Sciences, Inc. 33

35 Service and Repair The device contains no user-serviceable parts or components. Please contact Larada Sciences or your local authorized representative for all service and repair inquiries. Replacement components such as Air Filters, Treatment Hoses, Power Cords, and Applicator Bases are available from Larada Sciences or your local authorized representative. Proof of device ownership will be required in order to purchase replacement components. When calling for technical support, service or repair, Larada Sciences will need to know the serial number of the LouseBuster device. The serial number label is located on the back of the Control Unit. Limited Warranty The LouseBuster device is warranted free of defects in material and workmanship under normal use and operation for a period of one year or 500 hours, under the terms and conditions of the Larada warranty in place at time of purchase. Larada will repair or replace at its sole option, free of charge, any defective parts or products returned with prior authorization. Consumable items such as filters are excluded. Warranty does not cover products abused, misused or altered outside of the factory. All In-warranty repairs must be authorized by Larada s Service Department before proceeding. Troubleshooting If you experience any electrical or mechanical problems using the LouseBuster device, or if there are recurring technical problems: 1. Discontinue any treatment immediately and turn the device OFF. 2. Try turning the device back ON to see if the problem has been resolved. 3. Check to see if the Power Cord is connected and at least one indicator light on the Operating Status Panel is on, indicating that power is being supplied to the device. 4. Check to see that the Treatment Hose and Sensor Connector are properly connected. 5. Call Larada Sciences to talk directly with technical support personnel Larada Sciences, Inc. 34