Dr. Honle Dermalight 80 UV-B-311 nm User manual

OPERATING INSTRUCTIONS
dermalight®80
psoracomb
UV-B-311 nm – narrowband
PO Box 154, Ballajura, Western Australia, Australia 6066
Tel: [phone] Fax: [phone]
www.beatpsoriasis.com [email protected]
www.beatpsoriasis.com
This document must be read carefully before using the
dermalight80 product. Version 3.0
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Thank you for choosing the dermalight®80 from www.beatpsoriasis.com The
dermalight®80 is the original and most technically advanced phototherapy device
available. It is both convenient and economical and been proven highly effective by
various clinical trials for the treatment of many skin diseases. While several imitation
products exist, rest assured that you are using the latest product available. In order
to achieve the best possible results, please follow these instructions exactly. In most
cases, improvements in psoriasis can be seen in as little as 4 weeks and sometimes
only several days, but very noticeable improvements often take 2 months or more.
We suggest a minimum of 3 months is required to gauge if you respond well to this
treatment. We hope that you will be satisfied with the dermalight®80 and look
forward to hearing from you again soon. Please do not hesitate to contact us if you
require additional information or advice on using the product. Please read all the
attached information thoroughly before using your new product.
CONTENT
1. Pricing Notice for All Clients .......................................................................... 2
2. Environmental Notice...................................................................................... 2
3. Business Opportunity ..................................................................................... 2
4. Safety Information ........................................................................................... 3
5. Description....................................................................................................... 5
5.1. General........................................................................................................ 5
5.2. Scope of Delivery......................................................................................... 5
6. Operation.......................................................................................................... 6
6.1. Operation with the Comb Attachment.......................................................... 6
6.2. Operating Conditions................................................................................... 6
7. Fields of Application and Therapy Information ............................................ 6
7.1. Fields of Application..................................................................................... 6
7.2. Therapy Information..................................................................................... 7
7.3. Therapy recommendation............................................................................ 9
8. Maintenance Information .............................................................................. 11
8.1. Lamp Replacement, Repairs ..................................................................... 11
8.2. Cleaning the Hand Lamp........................................................................... 12
8.3. Cleaning and Disinfecting the Comb Attachment....................................... 12
8.4. Spare Parts and Accessories .................................................................... 13
9. Repair and Spare Parts Service ................................................................... 13
10. Technical Data ............................................................................................... 14
11. Warranty and Liability ................................................................................... 16
12. Environmental Protection ............................................................................. 16

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1. PRICING NOTICE FOR ALL CLIENTS
Please note that all invoices and credit cards are charged in AUSTRALIAN dollars, or
$AUD. Export orders are charged at the appropriate advertised AMERICAN dollar
rates, converted to AUSTRALIAN using the daily international money exchange rate
as published at www.xe.com Therefore, prices quoted in American are close
approximations only due to exchange rate fluctuations, and possibly credit card and
bank charges. E.g. if you have purchased a product advertised at $595 AMERICAN,
then your credit card will have been charged for $802 AUSTRALIAN using the
exchange rate below. Exchange rates change on a daily basis and some banks use
a different rate and may also charge their customer’s a conversion fee or other bank
fees for international transactions etc.
595.00 USD
United States Dollars =802.311 AUD
Australia Dollars
1 USD = 1.34842 AUD 1 AUD = 0.741608 USD
Australian customers are also charged the 10% GST. All other clients are exempt
from Australian taxes.
2. ENVIRONMENTAL NOTICE
In the interest of saving our environment BEATPSORIASIS.COM may use recycled
packaging and packaging materials where possible.
3. BUSINESS OPPORTUNITY
We trust that you will find our phototherapy devices an extremely successful
treatment for your skin condition. Phototherapy treatment is becoming increasingly
popular as patients are moving away from dangerous drugs and their side effects.
Phototherapy has been in use for many decades, and with recent advances in UV
globe technology is now the safest form of treatment for many skin conditions.
Subsequently, BEATPSORIASIS is seeking motivated people to join our worldwide
distribution network. If you are interested in marketing and selling Dermalight
products in your area, please do not hesitate to contact us. There is no requirement
to carry stock and no up front expenses.

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4. SAFETY INFORMATION
Read the operating instructions carefully before using the dermalight®80 for
the first time.
All important safety information is marked with this symbol. Please
follow these instructions carefully to prevent health risks and damage
to property.
dermalight®80 emits intense UV radiation which can be dangerous -
sunburn/skin burns, conjunctivitis, skin cancer and keratitis (retina
damage) - if used improperly, especially when overdosed.
Never operate without UV safety goggles! Your must wear the safety
goggles at all times.
Never look directly into the light with your eyes open. If treating your
face, keep eyes closes and goggles on at all times.
Perform irradiation only as described in the operating instructions or as
recommended by a doctor.
Never use the appliance in the bath tub!
Never use the appliance when housing or power cable are defect!
By using the appliance excessively (over months and years) the
formation of skin cancer may be encouraged.
Do not carry out a UV-therapy after photosensitization of the skin by
cosmetics or medicine.
Cover those parts of your body you don´t want to treat.
By use as agreed skin reactions and skin irritations are not excluded at
every time. The result of long time treatment are side effects, like
erythema, bubbles and erosions, pigmentation and itching.
The safe handling and smooth operation of the dermalight®80 presupposes
familiarity with all the basic safety regulations.
The operating instructions contain all essential information on how to operate the
equipment safely.
The operating instructions, especially the safety information and safety regulations,
must be observed by everyone working with this equipment.
The accident-prevention rules and regulations prevailing at the place of use must
also be observed.
The operator (doctor, clinic) must check at regular intervals that the equipment is
being used by personnel in line with the safety regulations.

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Additional safety instructions for doctors/clinics:
The operator (doctor/clinic) has to check the careful operation of the personnel
handling the equipment in regular intervals.
Before commencing work, those people who are to work with the dermalight®80
have to:
•Observe the regulations governing safety and accident prevention.
•Read the chapter on safety and the warnings contained in these operating
instructions and to observe these at all times during operation.
Hazards when using the equipment
The dermalight®80 was built according to the state of the art and in compliance with
recognized safety standards. The equipment must be used
•only for that purpose for which it was intended,
•only when in perfect working order.
Improper use can endanger the health of the user and/or third parties (including
damage to the skin and eyes) as well as impairing the equipment or other items of
property.
Any faults which might impair the safety of the equipment must be remedied
immediately.
Proper use
The dermalight®80 is a UV radiation appliance for the treatment of skin diseases.
Any other use of the equipment going beyond this shall be deemed improper and
may be hazardous.
The operator may operate the equipment only if all the user information contained in
these operating instructions is observed at all times. Failure to do so may render the
manufacturer's warranty null and void and jeopardize the success of the therapy.
The operator undertakes to observe the prescribed schedule for inspection and
maintenance work and the replacement of wear parts (e.g. lamps) this work entails.
The company Total Control Pty. Ltd. (Australia) H shall not be liable for any damage
caused by the use or improper use of the equipment.
Proper use also entails:
•adherence to all the information contained in the operating instructions
•adherence to the schedule for inspection and maintenance work
•adherence to the general and specific safety information and safety
regulations contained in these operating instructions as well as the prevailing
accident-prevention regulations.

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5. DESCRIPTION
5.1. GENERAL
dermalight®80 is a medical radiation appliance designed for mobile use. The
emission spectrum of its lamps lies in the UVB narrow band range.
Simple and universal use of the dermalight®80 is made possible by its low weight
and handy shape. Treatment of the scalp - normally a difficult exercise - is easy to
perform with the slip-on comb attachment.
Never start the dermalight®80 without first putting on safety goggles.
UVB radiation may harm your eyes!
5.2. SCOPE OF DELIVERY
The dermalight®80 is delivered with the following parts:
•dermalight®80 hand appliance with power-pack
•comb attachment
•UV-safety goggles with elastic headband
•operating instructions
•countdown timer

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6. OPERATION
Plug the dermalight®80 into a mains outlet (110 V, 60 Hz or 240v, 50Hz; please
ensure appropriate power supply for your location). Operate the dermalight®80 only
from properly installed socket outlets. With the rocker switch on the top of the
appliance you can switch the dermalight®80 on and off. After the appliance is
switched on there may be an ignition delay of up to 30 seconds before the lamps
emit a uniform light.
The dermalight®80 is ready for use immediately after lamp ignition, i.e. there is no
warm-up period.
6.1. OPERATION WITH THE COMB ATTACHMENT
To use the dermalight®80 with the comb attachment (Order No. 1637), slip on the
attachment from the front of the appliance until the two lugs on the comb snap into
the recesses in the dermalight®80. The attachment is correctly fitted when the four
guide ribs of the comb are inside the guide slots of the dermalight®80. The logo
then lies at the front of the dermalight®80.
6.2. OPERATING CONDITIONS
dermalight®80 is designed for use in dry rooms with an ambient temperature never
exceeding 45 °C.
Be sure to protect the appliance from chemical vapours and never use it in potentially
explosive atmospheres.
The appliance can be used at any angle.
7. FIELDS OF APPLICATION AND THERAPY INFORMATION
7.1. FIELDS OF APPLICATION
By using the dermalight®80 UV-B-311 nm it is possible to carry out UVB-therapy,
depending on the indications.
Indications: Given to the latest findings in photodermatology, this means that the
following indications can be treated with promise of success:
•psoriasis
•vitiligo
•acne
•dermatitis
•dermalight®80 can be used for local irradiation of small circumscribed
areas of skin all over the body, for wrinkles and for the scalp

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Contra-indications: The following contra-indications are valid for all radiation units:
•hyperthyroidism
•lupus erythematosus
•tumorous skin changes
•diseased hyperphotosensitivity (e.g. xeroderma pigmentosa)
•porphyrin disease
•floride tuberculosis or other floride processes
•accompanying medical treatment with potential skin damage or intensified
photosensitivity
•pregnancy, because there is no experience
7.2. THERAPY INFORMATION
The optimum dose for all indications corresponds to the factor 0.7 - 0.9 MED (=
minimal erythema dose). In order words, for treatment to be successful it is important
to perform irradiation to a level just below the erythema limit (i.e. until a slight
reddening of the skin becomes visible, which however does not become fully
discernible until after around 6 to 12 hours).
The MED varies from patient to patient and depends on the skin type (see table 1).
Your doctor will tell you in which class (1 - 6) you belong.
For the sake of simplicity we have based the following descriptions on skin type 2
(applies to the majority of Central Europeans).
For the therapy success it is essential to pre-treat your skin or scalp, i.e. to remove
scale.
Guide values for skin type 2, first exposure :
approx. 60 seconds for each irradiated area of the body;
approx. 5-6 minutes for the entire hair-covered scalp.
The duration of the first exposure for hair-covered scalp depends on the extent of the
hair covering and its thickness. The purpose of the comb is to part the hair and allow
the UV radiation to get through to the scalp (see Chapter 4.3. THERAPY
RECOMMENDATION).
The guide value for the percentage increase per exposure for skin type 2 is 25% to
30%.
In case of overdose (noticeable and visible sun burn or pronounced
reddening of the skin), shorten the irradiation period or discontinue
treatment.

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Guide values for the maximum final exposure time (to complete the irradiation
treatment) are:
approx. 3-4 minutes for each irradiated area or
approx. 2 times 20 minutes for the entire hair-covered scalp (f. ex. once in
the morning and once in the evening).
UV safety goggles guaranteeing 100% UV protection must be worn
during treatment. Suitable goggles are available as spare parts (see
Chapter 6. SPARE PARTS AND ACCESSORIES).
Use sun lotion with a high sun block factor (≥15) on your forehead.
Radiation intensity decreases as the lamps grow older. This means that
you must add an additional 10 - 20 % allowance to the exposure time
after approx. 200 - 300 hours in operation. Remember to deduct this
allowance again after replacing the old lamps with new ones.
For greater uniformity of irradiation we recommend combing your hair
during exposure from left to right and then from the front to the back.
Wear a glove on the hand holding the appliance to protect it from the
UV radiation.
skin type Description
1 light skin, red- or fair-haired, blue or green eyes, freckles always quick sunburn; scarcely or no bronzing even after repeated
treatments (Celtic type)
2 fair-haired, blue, grey or green eyes almost always sunburn; moderate bronzing after repeated
treatments (fair European type)
3 light brown or brown hair, brown eyes moderately often sunburn; progressive bronzing after repeated
treatments (dark-skinned European type)
4 dark brown or black hair, brown eyes
rarely sunburn; quickly beginning and clear bronzing (Mediterranean
type)
Table 1: Characteristics of the skin types

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7.3. THERAPY RECOMMENDATION
Consult your doctor for a recommendation on your initial treatment time.
Example 1: Psoriasis of the hair-covered scalp
Therapy: UV-B-311 nm therapy
Appliance: dermalight®80 with comb attachment
Patient's skin type: 2 (European average)
Irradiation distance: 2- 3 cm (is kept automatically by the comb
attachment)
Duration of first exposure: approx. 5-6 minutes for the entire scalp
Increase of exposure time
per follow-up exposure: approx. 20 - 30% of previous exposure time
Maximum exposure time: 2 times 20 minutes (entire scalp; e.g. one time in the
morning and one time in the evening) per treatment
Duration of treatment: 4 - 6 weeks, longer for particularly serious cases
Frequency of irradiation: 4 - 7 times per week. Only ever once per day.
Max initial treatment 3 months
If skin irritations appear, decrease the treatment time of the following treatment by
about 2 minutes. Only increase the time after two further treatments.
Example 2: Psoriasis of a small circumscribed area of skin
Therapy: UV-B-311 nm therapy
Appliance: dermalight®80 (without comb attachment)
Patient's skin type: 2 (European average)
Irradiation distance: approx. 1 - 2 cm
Duration of first exposure: approx. 45 - 60 seconds per irradiated area
Increase of exposure time
per follow-up exposure: approx. 20 - 30 % of previous exposure time
Maximum exposure time: approx. 3 - 4 minutes per irradiated area.
Duration of treatment: 3 - 4 weeks, longer for particularly serious cases
Frequency of irradiation: 4 - 5 times a week, every day for severe cases. Only
ever once per day.
Max initial treatment 3 months
If skin irritations appear, decrease the treatment time of the following treatment by
about 20 seconds. Only increase the time after two further treatments.

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Example 3: Treatment of Vitiligo or Acne
Distance: 3 cm, use the comb attachment as a distance holder. The comb
attachment does not influence the treatment.
Frequency: 3 times a week
Maximum treatment time: 4 min 40 sec
If skin irritations appear, decrease the treatment time of the following treatment by
about 20 seconds. Only increase the time after two further treatments.
You MUST cover the unaffected or normal skin with sun burn cream
if treating vitiligo or other skin pigmentation conditions

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8. MAINTENANCE INFORMATION
Daily: Check the filter glass for damage and dirt; check the housing for
damage.
Every 300 operation hours :
Replace the lamps.
Every 2 years: Maintenance by our Customer Service or a technician authorized by
us (applies only to commercial users but is compulsory to comply
with the German Medical Products Act).
8.1. LAMP REPLACEMENT,REPAIRS
To ensure a high level of radiation intensity at all times we recommend replacing the
lamps after approx. 300 operation hours.
Disconnect the appliance by unplugging the power-pack!
Use a suitable screwdriver to undo and remove the three screws from the housing,
place the filter glass on a soft clean cloth where it cannot be scratched, and lift off the
top half of the housing. With a turning action you can now take the lamps out of their
holders and replace them with new ones. Re-close the housing, put the filter glass
back in the opening, and screw the housing tight.
Safe operation of the dermalight®80 is guaranteed only when an undamaged
filter is fitted!
Only use original type UV-B-311 nm (Order No. 19174) as spare parts!

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8.2. CLEANING THE HAND LAMP
Disconnect the appliance by unplugging the power-pack!
Never wipe the hand lamp or the filter glass with a dry cloth. To clean dusty or dirty
surfaces, wipe with a damp soft cloth or sponge (add a little dishwashing liquid to
warm water).
Anti-static plastic cleaners are also suitable.
Never clean with concentrated disinfectant or solvent such as Sagrotan,
Lysoform, methyl alcohol or any other liquid containing alcohol.
8.3. CLEANING AND DISINFECTING THE COMB ATTACHMENT
The comb attachment (Order No. 1637) is skin-friendly and hygienic. Its poreless
surface makes it difficult for dirt and bacteria to accumulate.
To clean and disinfect the comb, see Section 5.2.
•At 25 °C the comb is resistant to the following chemicals:
• Baktolan, up to 5 % • Merfen
• Chinosol, up to 1 % • Perhydrol
• Elmocid Gamma, up to 2 % • Perodin
• Lugol's solution • Sagrotan, up to 2 %
• Mefarol, up to 1 % • Hydrogen peroxide, up to 40 %
• Merckojod, up to 1 % • Zephirol, up to 5%

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• Under no circumstances are you to use:
• Alcohol • Perchloroethylene
• Baktolan, concentrated • Sagrotan, over 2%
• Gasoline mix • Sidolin
• Tincture of iodine, 5% • Spirit of wine
• Phenic acid • Carbon tetrachloride
• Lysoform • Trichloroethylene
8.4. SPARE PARTS AND ACCESSORIES
•Lamp UV-B-311 nm (PL-S 9W/01) Order No. 19174
•Filter glass Order No. 1636
•Comb attachment Order No. 1637
•UV safety goggles with elastic headband Order No. 0029
•UV safety goggles “Profided” Order No. 0067
•Countdown timer Order No. 0466
Our current price list is available on request.
9. REPAIR AND SPARE PARTS SERVICE
For warranty claims, repairs and spare parts it is best to make use of our company’s
own facilities. If necessary, please contact:
PO Box 154, Ballajura, Western Australia, Australia 6066
Tel: [phone] Fax: [phone]
www.beatpsoriasis.com [email protected]
The power cable between the hand-held unit and the power-pack (series
reactor) may be replaced only by an original power cable type HO5W-2x0.75
mm2with integrally moulded anti-kink sleeves which have to be bonded to the
housing to prevent twisting.
For safety reasons, parts are to be repaired or replaced only the original supplier or
an authorized dealer.

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10. TECHNICAL DATA
Type dermalight®80 UV-B-311 nm
Order No. 19233 110v / 19158 240v
Power supply #1, 110v 110 V ~ / 60 Hz (mainly USA)
Power supply #2, 240v 240 V ~ / 50 Hz (European)
Power consumption 20 VA
Lamp 1 x UV-B-311 nm (PL-S 9W/01)
Dimensions (L x W x H) 325 x 82 x 40 mm
Weight (without power cable) 300 g
Radiation outlet 110 x 40 mm
Operating temperature 5 - 45 °C
MPG class IIa
Protection class II, totally insulated
Hand-held unit drip-proof 6IPX1
Marking CE 0123
All technical specifications are subject to technical alterations.
UV intensity at a distance of 3 cm: UVB radiation intensity:
E(UV-B-311 nm) 3.5 mW/cm2

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Symbols:
device of protection class II
!Attention, see operating instruction
part of application: type B
not ionised radiation
6drip proof IPX1
(Subject to technical alteration!)
Therapy spectrum:
Relative spectral radiation distribution (%)
Wave length [nm]

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11. WARRANTY AND LIABILITY
In principle, the general terms of sale and delivery of Beat Psoriasis shall apply.
These shall be submitted to the operator upon the signing of contract at the very
latest. There shall be no warranty or liability claims in the event of personal injury or
damage to property if these are attributable to one or more of the following causes:
•the use of the dermalight®80 for a purpose other than that for which it was
intended
•failure to observe the information on the assembly, commissioning, operation
and maintenance of the unit contained in the operating instructions
•improper assembly, commissioning, operation and maintenance of the
dermalight®80
•operation of the dermalight®80 with defective and/or malfunctioned safety
and protective equipment
•unauthorized structural modifications of the dermalight®80
•inadequate checking of wear parts
•repairs performed by persons who are not authorized
•catastrophes caused by foreign bodies or acts of God
12. ENVIRONMENTAL PROTECTION
According to care and careful use, the lifetime of the appliance is between 5-10
years. When the maximum life time is reached, please return the lamps or complete
appliances to us. We will ensure that they are disposed of in an environmentally
acceptable manner.
PO Box 154, Ballajura, Western Australia, Australia 6066
Tel: [phone] Fax: [phone]
www.beatpsoriasis.com [email protected]
We will ensure that they are disposed of in an environmentally acceptable manner.