SAALMANN Saalux User manual

User manual Saalux®UV comb page 1
User Manual

User manual Saalux®UV comb page 2

User manual Saalux®UV comb page 1
User manual
Saalux®UV comb
UV-B (311 nm) narrow band
Version
EU (230V/50Hz)
☐No. 07-02-000-01
UK (240V/50Hz)
☐No. 07-02-000-03
JP1 (100V/50Hz)
☐No. 07-02-000-06
JP2 (100V/60Hz)
☐No. 07-02-000-08
US (120V/60Hz)
☐No. 07-02-000-10

User manual Saalux®UV comb page 2
Dear customer, we are delighted that you decided to purchase a Saalmann
therapy device. You made an excellent choice as the light weight Saalux®UV
comb sets new standards in terms of usability and design. The one-piece comb
attachment comprises two rows of comb tines and a transparent cover, which
protects the UV lamp from soiling. The detachable comb attachment facilitates
easy cleaning by rinsing and flushing out scales or hairs which usually soil the UV
comb in the course of treatment.
The following directions for use will enable you to familiarise yourself with
the therapy device. Please review them carefully!

User manual Saalux®UV comb page 3
Content
1 Scope of Delivery 4
2 Accessories and Spare Parts 4
3 Safety Information 4
4 Key to symbols 7
5 Intended Use 8
6 Basic Information on UV Phototherapy 8
7 Indications 9
8 Contraindications 9
9 Initial Operating Instructions 9
10 Therapy Recommendation 10
11 Cleaning and Disinfection 17
12 Transport and Storage 18
13 Errors and Troubleshooting 18
14 Life cycle and service life 18
15 Maintenance and Repair 19
16 Warranty 19
17 Electromagnetic compatibility 19
18 Spectral Distribution of the Flow of Radiation 20
19 Technical Data 20
20 Disposal instructions 21
21 Manufacturer contact information 21
Appendix 1 –Electromagnetic compatibility 22
Appendix 2 –Patient diary 24

User manual Saalux®UV comb page 4
1 Scope of Delivery
The set consists of the therapy device with UV lamp and comb attachment, UV
protective goggles, count-down timer and a user manual.
2 Accessories and Spare Parts
Comb attachment Item No. 07-02-005-01
User manual UK Item No. 07-02-001-02
UV-protective goggles, red Item No. 07-02-002-01
Count down timer Item No. 07-02-003-01
3 Safety Information
„Caution“ safety information: this sign precedes important notices in
the user manual.
The therapy device may only be used for the indications specified in
this user manual.
The therapy device may only be used for the „intended use“
specified in this user manual. Any use beyond the defined scope is
considered „not as intended“ and will immediately render the
warranty void. The manufacturer accepts no responsibility for
personal injury or damage to property resulting from „not as
intended“ use.
The therapy device may only be used when in proper condition and
with the original accessories.
The device may not be altered.
If the power cord is damaged, you must have it replaced by
Saalmann to avoid the risk of electric shock.
The therapy device may only be operated in dry rooms and in the
temperature range stated in this user manual.

User manual Saalux®UV comb page 5
Water and electricity are a dangerous combination! To avoid risk of
electrocution:
–do not use this equipment in wet surroundings (e.g. in the
bathroom or near a shower or swimming pool),
–do not let water run into the appliance.
The use of this device next to other equipment should be avoided,
as it may result in improper operation. If use in the manner
described above should nevertheless be necessary, this equipment
and the other equipment should be checked for proper operation.
This device emits UV radiation through the transparent comb
attachment, which can cause eye or skin irritation. Avoid the UV
radiation of eyes and healthy skin. The UV radiation is not visible for
the human eye and can lead to corneal inflammation (photokeratitis)
and eye inflammation (photoconjunctivitis) within a short time.
It is imperative that during a therapy session, you wear the UV
protective goggles included in the scope of delivery. Also, avoid
looking into the UV lamp with unprotected eyes; immediately switch
off the therapy device after treatment and also during short-term
interruptions in the treatment session.
Never operate the device without comb attachment.
UV-radiation can cause the skin burn within a short period of time. It
is imperative that you pay attention to the therapy recommendations
specified in the user manual.
To avoid erythema (sun burn), healthy skin (e.g. ears) must be
protected with a high protection factor sun cream, which is to be
applied to those areas in due time before the treatment session (see
page 8)
The intensive use of the therapy device over years can promote the
development of skin cancer. Avoid excessive sun exposure during
the treatment cycle; also, adjust your leisure behaviour during this
time. You should not visit tanning studios while using the device in a
treatment cycle.

User manual Saalux®UV comb page 6
This device is not intended for use by persons with reduced
physical, sensory or mental capabilities, or lack of experience and
knowledge, unless they have been given supervision or instruction
concerning use of the equipment to avoid the risk of fire or burns.
This device is not intended for independent use by children. The
treatment of children is carried out exclusively by adults. Children
should be supervised to ensure that they do not play with the
equipment to avoid the risk of fire and burns.
Do not leave the device unattended when it is switched on to avoid
the risk of fire or burns.
Check if the voltage indicated on the device corresponds to the local
mains voltage before you connect the equipment to avoid risk of
electrocution or permanent damage to the device.
If the wall outlet used to power the device has defective
connections, the plug of the device will heat up. Make sure that the
plug of the device is inserted into a properly installed wall socket to
avoid the risk of fire or burns.
Make sure that you can unplug the power cord from the wall outlet
at any time.
Always unplug the device after use and in case of a power failure to
avoid risk of damage to the equipment.
Protect the device against unauthorized use:
- unplug the AC adapter from the socket immediately after use,
- store the device securely so that unauthorized persons cannot
access the device (e.g. by locking it away).
Do not use it near children and never leave the device unattended
(Danger of UV exposure and strangulation).
Do not subject the equipment to heavy shocks to avoid risk of
damage to the lamp.
RF communications equipment (radios) and their accessories
should not be used within 30 cm of the components and cables of
the Saalux®UV Comb. Observe the recommended EMC protective
distances in Appendix 1. Failure to do so may lead to a reduction in
the performance of the device.

User manual Saalux®UV comb page 7
4 Key to symbols
Symbols in the user manual and on the unit:
Caution:
Important note!
Medical Device
Caution:
Ultraviolet radiation!
Manufacturer‘s CE-
declaration with no. of
Notified Body
Do not stare at light
source!
Manufacturer
Wear UV protective
goggles!
Item No.
Read the user
manual!
Batch Code
Type BF applied part
Class II equipment
Keep dry!
Disposal instructions:
Do not dispose of the
equipment with
domestic waste!

User manual Saalux®UV comb page 8
5 Intended Use
The unit is intended to be used in closed rooms. Allow the unit to reach room
temperature before conducting a treatment. The device may only be used in a dry
environment. The required minimum distance to shortwave microwave devices
depends on their frequency and transmission power and is defined in the EMC
tables (see attachment 1). For additional information, please refer to item 9 in the
operating instructions.
At the start of the therapy, approx. 3 - 5 treatments per week are to be conducted.
Exposure time depends on the patient’s individual sensibility and skin type.
Special care has to be taken to exceeding the erythema threshold (development
of sun burn). We refer to the specific instructions in this user manual. Due to the
intermittent appearance of clinical symptoms, an according maintenance therapy
in a domestic setting is indicated.
The treatment is conducted based on a doctor’s recommendation and in
accordance with the treatment guidelines laid down in the user manual. Any other
use going beyond or deviating from the defined scope of usage is considered
„improper use” and may lead to health impairment and injury.
6 Basic Information on UV Phototherapy
UV phototherapy is an
established procedure,
recognized for decades for the
treatment of various skin
diseases, particularly
psoriasis, neurodermatitis and
vitiligo. UV radiation affects
the upper skin cells and, after
repeated application, positively
influences the immune system
and the skin‘s regeneration behaviour. The UV-B 311nm narrowband spectrum
emitted by the UV comb is a highly selective spectral range of natural sunlight,
which is therapeutically effective while causing few side effects.

User manual Saalux®UV comb page 9
7 Indications
The Saalux®UV comb is used for the following indications:
•Psoriasis
•Vitiligo
•Neurodermatitis
8 Contraindications, risks and side effects
The UV therapy must not applied in case of:
•Increased sensitivity to light or an increased risk of
skin cancer
•Taking photosensitizing medication
•History of malignant skin tumors
•Severe actinic skin damage
•Seizure disorders
Risks and side effects:
•Severe erythema and blistering due to overdose
•Phototoxic reactions due to accidental administration
of a photosensitizer
•Provocation of light dermatoses (PLD)
•Conjunctivitis and keratitis (lack of eye protection)
•Photoaging of the skin, age spots (UV lentigines) and
hyperpigmentation
•Erythema (sunburn)
•Dry skin
•Itching
9 Initial Operating Instructions
The device may only be used with a power supply that matches the supply
voltage specified on the rating plate. To ensure safe operation of the unit, all its
cables, plugs, control elements, and housing components must be in faultless
condition. Prior to each use, check the device for possible damage; a defective
unit may not be operated. Pay attention to the references on the unit and in the
user manual. Please switch the unit off after you finished a treatment session.

User manual Saalux®UV comb page 10
10 Therapy Recommendation
Basic operation:
The applied UV dose is controlled by the treatment duration of a therapy session.
The treatment duration is to be increased until a slight reddening of the skin (mild
sunburn or erythema) occurs with some delay, which has subsided after 24 hours
at the latest. This so-called erythema threshold is different for each user and
determined by the individuals’skin type. At the beginning of the therapy, always
start with low treatment durations, which are then gradually increased from
session to session until the erythema threshold is reached.
During UV irradiation, the comb attachment should rest on the skin to ensure a
constant irradiation intensity during the application. For the treatment of a larger
skin area (e.g. scalp), the treatment time should be increased accordingly. The
UV comb should then be moved evenly over the entire area with the comb
attachment resting on it.
Removing dandruff:
Plaques and scales absorb
the UV radiation and prevent
the UV radiation from
penetrating into the diseased
skin layers. In case of
extensive manifestations,
thoroughly remove plaques
and scales before starting
the UV therapy (e.g. with the
Saalux®dandruff solution, see page 29).
UV protection
Prior to starting the treatment, healthy skin areas (the ears, amongst others)
should be covered or creamed with an according light protection screen in due
time (please consider application time!).
Prior to or during a therapy session, the skin must be free of topical applications
like, e.g. ointments; do not use sun protection on the skin that is to be treated.
Certain pharmaceuticals increase the skin‘s UV-sensitivity, a fact you might want
to discuss with your physician!

User manual Saalux®UV comb page 11
Moist skin
Moist skin is more receptive to UV radiation. Therefore the application on moist
skin (e.g. after washing the scalp) may accelerate the success of the therapy.
Operation of Timer
At the onset of the treatment session, please make sure that the count-down
timer is functioning properly (e.g. battery o.k.?)
Prior to starting a treatment session, plug the device into a suitable outlet, put on
the protective goggles and keep the device switched on for approx. 5 min in order
to achieve a stable UV-output.
Please set the provided count-down timer by
pressing the according buttons „MIN“ for minutes
and „SEC“ for seconds to the desired treatment
time. Pressing the „Stop/Start“-button starts or
interrupts the countdown for treatment time. By
simultaneously pressing both „MIN“ and „SEC“
push buttons, the count-down timer resets to
„00:00“.

User manual Saalux®UV comb page 12
Finding the right dose and treatment duration:
It is common nowadays to use the classification made by the American
dermatologist Thomas Fitzpatrick in 1998 to define various skin types.
Skin type 1: pale white skin; blond or red hair - always burns, never tans
Skin type 2: fair; blond hair - usually burns, tans minimally (fair European type).
Skin type 3: fair, light-brown or brown hair, tans uniformly after repeated sun
exposure (dark European type T).
Skin type 4: brown or black hair - rarely burns, always tans well (Mediterranean
type)
Skin type 5: brown skin, very rarely gets a sunburn
Skin type 6: black skin, never gets sunburn
For vitiligo patients, the pigment-free skin areas to be treated are decisive for
determining the skin type (lighter skin type).
Depending on the skin type, the following dosages are recommended, bearing in
mind that these dosages are shown for the treatment of a single area and
additionally for the entire scalp (6 times the area). Incorrect application can lead
to overdose in the form of erythema (sunburn)! Special attention should be paid to
the inner surfaces of the outer ears. They should not be treated for an extended
period since they are extremely sensitive to UV light (UV protection see above).
The treatment times indicated are mere guide values; please consult with your
dermatologist to determine your individual numbers. Upon reaching the highest
dosage indicated for the according skin type, it is not sensible to increase further
the dosage arrived at is to be maintained. Keep in mind, however, that excessive
doses can lead to an acute aggravation of your skin condition (the so-called
Köbner phenomenon).

User manual Saalux®UV comb page 13
Dosage recommendations and treatment times:
Skin type
1
Session
Dosage
(mJ/cm2)
Time for
single area
(min:sec)
Time for
complete scalp
(6-fold area) *
(min:sec)
1
53
0:15
1:30
2
105
0:30
3:00
3
158
0:45
4:50
4
210
1:00
6:00
5
263
1:15
7:30
6
315
1:30
9:00
…
…
…
…
no
increase
max. 788
max. 3:45
max. 22:30 **
Skin type
2
Session
Dosage
(mJ/cm2)
Time for
single area
(min:sec)
Time for
complete scalp
(6-fold area) *
(min:sec)
1
70
0:20
2:00
2
140
0:40
4:00
3
210
1:00
6:00
4
280
1:20
8:00
5
350
1:40
10:00
6
420
2:00
12:00
…
…
…
…
no
increase
max. 1050
max. 5:00
max. 30:00 **
Skin type
3
Session
Dosage
(mJ/cm2)
Time for
single area
(min:sec)
Time for
complete scalp
(6-fold area) *
(min:sec)
1
88
0:25
2:50
2
175
0:50
5:00
3
263
1:15
7:30
4
350
1:40
10:00
5
438
2:05
12:30
6
525
2:30
15:00

User manual Saalux®UV comb page 14
…
…
…
…
no
increase
max. 1,313
max. 6:15
max. 37:50 **
Skin type
4, 5 and 6
Session
Dosage
(mJ/cm2)
Time for
single area
(min:sec)
Time for
complete scalp
(6-fold area) *
(min:sec)
1
105
0:30
3:00
2
210
1:00
6:00
3
315
1:30
9:00
4
420
2:00
12:00
5
525
2:30
15:00
6
630
3:00
18:00
…
…
…
…
no
increase
max. 1,575
max. 7:30
max. 45:00 **
(*) For partial areas, reduce the treatment time accordingly.
(**) Longer exposure times can be divided between morning and evening
sessions.

User manual Saalux®UV comb page 15
Conducting the Therapy
Only use the device in a dry environment. Always use the UV protective goggles
provided and never look into the UV lamp with unprotected eyes! While you
conduct the treatment, no other persons should be in the vicinity unless they are
also protected from the UV radiation.
Always protect your eyes with
the UV protective goggles!
Connect the device to a suitable power outlet, put on the protective goggles and
leave the device switched on for approx. 5 min before each start of therapy to
achieve stable UV emission. For this time, place the switched-on device on a
suitable surface with the comb attachment facing downwards.
Now start the short-time timer with the previously set therapy duration. Please
position the count-down timer where it is easily visible and acoustically
perceivable for you; after counting down to zero, an acoustic signal will sound for
approx. 30 seconds. You can turn it off by pressing any button. After pressing the
Start/Stop button, the previously set or lapsed time will appear in the display
again.
Now start the treatment of the affected
skin areas. To treat a single area, place
the UV comb flat on the corresponding
skin area for the planned therapy
duration. The hair parter or comb
attachment facilitates reaching the hairy
scalp skin and ensures the required
treatment distance.

User manual Saalux®UV comb page 16
In case of the entire scalp the
treatment is to take place slowly,
distributed uniformly over the head
and against the direction of hair
growth. The comb attachment
additionally serves here as a hair
divider for reaching the hairy scalp.
The treatment should always be
performed with the comb attachment
mounted.
The treatment should be conducted three to five times weekly. The duration of
the treatments depends on the type and severity of the skin disease. For the
treatment of psoriasis and neurodermatitis, 20-25 sessions are usually sufficient
until the skin symptoms have subsided. Vitiligo treatment can take considerably
longer. If there is no success after 3 months at the latest, contact your treating
physician to clarify a continuation of the treatment.
Therapy monitoring:
Following every treatment session, monitor the treated skin areas for therapeutic
success as well as for possible side effects:
Should you discern side effects like a sun burn or painful change in the diseased
skin, you have to reduce the dose for the next treatment by 40% and you may
only continue with the treatment after the side effects have abated. If in doubt,
consult your attending physician.
Should you discern side effects like a sun burn or painful change in the healthy
skin, make sure to provide better protection for the next treatment like using
sunscreen with a high protection factor or more carefully cover these areas with
textiles.
Should you not experience any successful therapy outcome at all, gradually
increase the dose as described in the tables. If you have reached the maximum
dose according to your skin type and still do not notice any therapeutic effect, the
service life of the UV lamp may be expired (see chapter 14). If in doubt, consult
your attending physician.

User manual Saalux®UV comb page 17
After every individual treatment, document your
therapy outcome and success in the patient diary
provided and discuss your therapy results regularly
with your attending physician.
End of a treatment series:
To maintain the positive treatment outcome, it is recommended to „phase out“ the
therapy after the lesions have disappeared. This can be done by e.g. decreasing
daily treatment for the next 3 weeks to 3 times weekly, for 3 weeks to 2 times
weekly and for 3 weeks to once a week.
11 Cleaning and Disinfection
Prior to cleaning and disinfecting, switch off the device and pull the plug from the
outlet. Let the device cool off before you begin cleaning. You achieve better
cleaning results if you pull the comb attachment from the unit and clean it
separately.
Wipe the comb housing with a
moist cloth. If needed, the comb
attachment can be detached from
the housing and cleaned on the
inside and outside under running
water with a mild soap or dish
detergent. Avoid wiping either
device or comb attachment with a
dry cloth which can scratch the
surface.
Do not use aggressive or solvent-based cleaners. These affect the surfaces of
the device. Avoid any penetration of liquids during cleaning.

User manual Saalux®UV comb page 18
When using the device by several patients, the comb attachment must be
cleaned and disinfected before any patient change, in order to prevent infections
between patients. The following disinfectants can be used for this purpose:
• Descosept Spezial (wiping disinfection)
• Microzid sensitive liquid (wiping disinfection)
• Sani Cloth Active (wiping disinfection)
For a sufficient disinfecting effect, the application instructions of the respective
manufacturers must be observed. If other disinfectants are used, only products
suitable for acrylic glass are to be selected.
12 Transport and Storage
Protect the UV comb during transportation from undesirable shocks; the UV lamp
may be damaged (glass breakage). Store the therapy device in dry rooms and do
not expose it to high temperatures.
13 Errors and Troubleshooting
UV lamp does not light - Check the outlet or use another outlet. Verify that
the UV lamp is tightly inserted into the socket.
First switch off the device and unplug the power
cord.
If this did not fix the problem, contact the address specified in the manual.
14 Life cycle and service life
The service life of the UV comb is essentially dependent on the frequency of use.
The average service life of the UV lamp is 500 hours. After this runtime, UV-
radiation decreases. This also becomes evident by a decreasing therapy result. A
defective or poor UV lamp may only be replaced by the manufacturer or
professionals trained and authorized by the manufacturer. The use of a wrong UV
lamp can cause burns. After replacing the UV lamp, the treatment duration has to
be determined again (see chapter 10).