Section II - Texas Department of State Health Services
Contents
1. C One visible to a person entering the tanning facility and one in each tanning room in a location visible to a person about to use the tanning device From section 229 350 a A tanning facility operator shall post a warning sign in a conspicuous location From section 229 350 b A tanning facility operator shall post a warning sign one sign for each tanning device in a conspicuous location that is readily visible to a person about to use the device DMDG 111 Revised 11 2008 Tanning Facility Compliance Assistance Packet Section II Page 6 9 1 D Answers A and C From section 229 351 a Only tanning devices manufactured and certified to comply with 21 Code of Federal Regulations CFR Part 1040 1040 20 Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products shall be used by or sold to tanning facilities From Title 21 CFR Part 1040 20 c 3 Each sunlamp product shall incorporate a control on the product to enable the person being exposed to terminate manually radiation emission from the product at any time without disconnecting the electrical plug or removing the ultraviolet lamps From section 229 351 d Tanning device remote timers shall be installed and located so that the customer may not set or reset the customer s own exposure time True False 1 True See section 229 352 a 2 True See section 229 354 d 3 False See section 229 35 1 c and 229 351 d 4 True See section 229 353 b 5 True2. See section 229 351 h 6 False See section 229 352 a 7 True See section 229 351 c 8 True See section 229 355 9 False See section 229 35 1 c 10 True See section 229 351 a Title 21 CFR Part 1040 20 d 1 1 requires that the tanning device labeling contain a warning statement with the words WEAR PROTECTIVE EYEWEAR FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG TERM INJURY TO THE EYES 11 True See section 229 351 a This is required by Title 21 CFR Part 1040 20 d 1 vi 12 False See sections 229 354 c 2 The operator must ensure that no individual is allowed to use a tanning device more than once every 24 hours The operator should also evaluate the customer s total number of tanning sessions in determining the maximum exposure interval for that customer 13 False See section 229 351 d The timer must be located so that the operator controls the exposure time and the timer cannot be set or reset by the customer 14 False See section 229 35 1 a Title 21 CFR Part 1040 20 d iv requires the tanning device to be labeled with A recommended exposure schedule including duration and spacing of sequential exposures and maximum DMDG 111 Revised 11 2008 Tanning Facility Compliance Assistance Packet Section II Page 7 15 16 17 18 19 20 21 22 23 24 25 exposure time in minutes True See section 229 351 a and 229 353 b 4 The operator s manual is part of the tanning d
3. Tanning Facility Compliance Assistance Packet Section II Page 1 TEXAS DEPARTMENT OF STATE HEALTH SERVICES DRUGS AND MEDICAL DEVICES GROUP Section HI Test Your Knowledge The following questions were developed from the Rules for Licensure of Tanning Facilities the Rules A Tanning facility operator see section 229 353 b of the tanning rules should be able to obtain a good score on this test To help you understand the importance of specific requirements the following questions have been marked with symbols to identify possible safety issues and requirements that if not complied with could result in the detention of a tanning device Possible safety issue Issue that could result in the detention of a tanning device MULTIPLE CHOICE 1 The operator must not allow a customer to tan without OA Tanning lotion OB Protective eyewear OC Anelectric fan OD Bright lighting in the tanning room For answer see section 229 352 a 2 Who must provide FDA approved protective eyewear OA The customer OB The Department of State Health Services OC The tanning facility OD None of the above For answer see section 229 352 a b and c 3 Ifa customer tanned at 3 00 p m today what is the earliest time they can tan tomorrow DA 11 00 a m OB 6 00 a m OC 3 00 p m OD None of the above For answer see section 229 354 c 2 DMDG 111 Revised 11 2008 Tanning Facility Compliance Assistance Packet S
4. air of protective eyewear when tanning A tanning facility must have a written incident log documenting all alleged injuries or complaints involving a tanning device Once they are in the tanning room customers are free to set their own ultraviolet exposure interval regardless of the exposure length determined by the tanning facility operator Operator training must be documented It is okay to have lamps in your tanning device s that are different than those recommended by the manufacturer as long as they are equivalent to the manufacturer s recommended lamps and the facility has a user s instruction sheet documenting the equivalency If protective eyewear is not available it is okay for customers to place either a towel or cotton balls over their eyes during the tanning session The Operator on duty determines the tanning exposure interval for each customer by using the exposure schedule on the front of the tanning device and an estimation of the customer s skin type using the Fitzpatrick scale The Department of State Health Services must be notified in writing within five working days of your becoming aware of a tanning injury involving one of your tanning devices The customer is paying for a full maximum interval tanning session and therefore they have a right to go the full time on their first tanning session Labeling on the tanning device itself must warn customers to wear protective eyewear There must be labeling in a l
5. anied by clean and properly sanitized protective eyewear From section 229 352 c Protective eyewear shall be located in the immediate proximity of each tanning device and shall be provided without charge to each user of a tanning device 3 1 C 3 00 p m From section 229 354 c 2 The operator must ensure that no individual is allowed to use a tanning device more than once every 24 hours 4 1 A 1 Overexposure to ultraviolet light cause burns 2 Pregnant women should consult their physicians before using a tanning device See section 229 354 a 5 B The tanning facility operator From section 229 351 c The operator shall limit the exposure time of a customer on a tanning device to the maximum time recommended by the manufacturer taking the customer s skin type into consideration 6 1 D All of the above From section 229 351 c The operator shall limit the exposure time of a customer on a tanning device to the maximum time recommended by the manufacturer taking the customer s skin type into consideration The exposure schedule is provided by the manufacturer and recommends maximum exposure times based on skin type and number of tanning sessions The operator must ensure that the maximum exposure time for the device is never exceeded 7 1 C The manufacturer s maximum recommended exposure time From section 229 351 b The maximum timer interval shall not exceed the manufacturer s maximum recommended exposure time 8
6. answer see 229 351 c Which of the following best describes the maximum timer interval maximum time to which the timer can be set for a tanning device OA 30 minutes OB Varies with the customer s tanning history OC The manufacturer s maximum recommended exposure time OD The maximum time for the timers that are sold in your area For answer see 229 351 b Which warning signs must be posted in a tanning facility OA One that can be seen from the exterior of the building and one in each tanning room in a location visible to a person about to use the tanning device OB One that can be seen from the exterior or the building and one in a location that is visible to a person entering the tanning facility OC One visible to a person entering the tanning facility and one in each tanning room in a location visible to a person about to use the tanning device OD One sign that can be seen from the exterior of the building one in an entryway and one in each of the tanning facility s tanning room For answer see 229 350 a and b DMDG 111 Revised 11 2008 Tanning Facility Compliance Assistance Packet Section II Page 3 9 Each tanning device must have a OA Remote timer OB 30 minutes timer OC Emergency cut off switch OD Answers A and C For answer see 229 351 ARE THE FOLLOWING STATEMENTS TRUE OR FALSE Or Orr Or Orr NOR 10 11 12 13 14 15 Customers are required to use a p
7. d make sure while operating a tanning facility that you keep a copy of the tanning rules available for your reference 15 or more Poor We would recommend that you not operate a tanning facility until you have received additional training and become more familiar with the tanning rules SCORE DMDG 111 Revised 11 2008
8. ection II Page 2 a OF 4 The tanning facility operator must give each customer a written statement containing six specific warnings Which pair of statements includes two of the six required warnings OA 1 Overexposure to ultraviolet light causes burns Pregnant women should consult their physicians before using a tanning device Repeated exposure may result in immature aging of the skin Protective eyewear must be worn while tanning The tanning device must be sanitized once a day When a tanning device is in use by an individual no other person shall be allowed to remain in the tanning device area The consumer contact surfaces are not to exceed 115 degrees Fahrenheit 2 Failure to use the eye protection provided to the customer by the tanning facility may result in permanent damage to the eyes For answer see section 229 354 a OB OC D OE OD Who sets and controls the customer s length of exposure tanning time OA The Department of State Health ServicesOB The tanning facility operator OC The customer OD None of the above For answer see section 229 35 1 c Which of the following must be used by the tanning facility operator to determine a safe exposure time tanning time for a customer OA The maximum exposure time for the tanning device manufacturer s recommended time OB The tanning device s exposure schedule manufacturer s recommended time OC Thecustomer s skin type OD All of the above For
9. evice labeling required by 21 CFR Part 1040 20 e 1 False See section 229 351 h False See section 229 354 c This section requires that An individual record shall be kept of each consumer s total number of tanning visits exposure lengths in minutes times and dates of exposures any injuries or illnesses resulting from the use of a tanning device Appointment books and sign in sheets are not individual records which document each consumer s total number of tanning visits True See section 229 354 b 1 False See section 229 35 1 j False See section 229 356 c The operator shall clean and properly sanitize the body contact surfaces of a tanning device after each use with a sanitizer registered with the USEPA True See section 229 351 d False See section 229 356 d The strength of your sanitizer must be tested at least once per day and the results should be recorded in a log False ee section 229 351 c The operator must control the customer s exposure time True See section 229 350 c 1 and 2 Check the size of your warning signs True See section 229 354 c G H and I The customer must complete this part of the tanning record Number Missed 0 4 Excellent You know the tanning rules 5 9 Good You have a good working knowledge of the tanning rules 10 14 Adequate You probably know enough to operate a tanning facility however you should definitely review the tanning rules an
10. he amount of ultraviolet radiation will always be less than the maximum for the device It is okay to use an appointment book to record the tanning histories for all of your customers as long as you record the day the customer tanned the time they started tanning the length of the tanning exposure which tanning device they used and include the operator s initials A customer 18 years and older must read and sign a statement that they have read and understood required warnings the first time they tan in your tanning facility and if you have tanning contracts each time a tanning contract is signed Its okay for a child to be in the tanning room while their parent tans as long as both the parent and child are wearing protective eyewear As long as an USEPA approved sanitizer and towels are left in each tanning room for the use of the customers it is okay for the facility to clean the devices only once a day or sporadically during the day Even if there is a functional timer on the tanning device there must be a remote timer that overrides the timer on the tanning device This remote timer must be located so that a customer using the tanning device cannot set or reset it The strength of your facility s sanitizer solution should only be tested when a new working solution is prepared If the Operator on duty sets the remote timer for ten minutes on a twenty minute tanning device the customer can tan longer by setting the timer on the device
11. itself The dimensions of DSHS required warning signs are 17 X 22 inches and the warnings must be printed in red ink The customer s individual tanning record should indicate the customer s skin type as determined by the customer using the Fitzpatrick scale and any past history of skin cancer involving themselves or their family DMDG 111 Revised 11 2008 O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False Tanning Facility Compliance Assistance Packet Section II Page 5 ANSWER SHEET For any answers that you get wrong you are strongly urged to read the applicable section of the Rules for Licensure of Tanning Facilities 25 TAC 229 341 229 357 Rules If you operate a tanning facility in the State of Texas and have not read the Rules in the past six months we would suggest that you review them Multiple Choice 1 1 B Protective eyewear From section 229 352 a The operator shall not allow a person to use a tanning device if that person does not use protective eyewear that meets the requirements of the United States Food and Drug Administration 2 1 C The tanning facility From section 229 352 a Each customer shall be provided with protective eyewear and instructions for their use From section 229 352 b Before each use of a tanning device the operator shall ensure that each tanning device is accomp
12. ocation where the customer can easily read it on each tanning device that indicates what lamp the manufacturer recommends for that tanning device It is not important to determine when the customer tanned last as long as it was not earlier in the day It is okay to place the remote timer in the same room as the tanning device as long as it is far enough away that the customer would have to get out of the device in order to reset it There doesn t have to be a label containing a schedule for the exposure intervals of each skin type on the tanning device if the operator discusses skin types with the customer and uses a chart at the front desk to determine how long they should tan Tanning facilities must have a separate user s manual for each tanning device they operate DMDG 111 Revised 11 2008 that overrides the timer on the tanning device itself O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False O True O False Tanning Facility Compliance Assistance Packet Section II Page 4 a Ff P FP F 16 17 18 19 20 21 22 23 24 25 Its okay to leave burned out lamps in your tanning device s until there are enough burned out lamps to warrant purchasing a new box of lamps since with fewer working lamps t
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