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PSD1111/10
User manual
1
ENGLISH 6
DEUTSCH 20
FRANÇAIS 35
NEDERLANDS 49
PSD1111
Date of issue: april 2014, version 1.
Stand: April 2014, Version 1 ist.
Date d’édition: Avril 2014, la version 1.
Datum van uitgave: april 2014, versie 1.
6
ENGLISH
Introduction
Read this user manual carefully before you use the Philips BlueControl
and save the user manual for future reference. To achieve optimal
treatment results, use the device according to the treatment schedule
and the instructions in this user manual.
List of product codes
- Kit PSK0101/10
- Device PSD1111/10
- Strap PSS1110/10
- Adapter PR3089
Intended use
The Philips BlueControl is a wearable medical device using blue LED light
for symptom relief of psoriasis vulgaris. The device is wearable on the
extremities (excluding plaques located on the palms of the hands or soles
of the feet) and is intended to be used in the home environment during
light activities such as watching TV or reading a book. The device is
positioned on the target zone by means of a xation strap. The device is
powered by a rechargeable battery. The Philips BlueControl is intended
to be used and operated by adults only (above 18 years of age) and in
accordance with the safety procedures and operating instructions given
in the user manual. Philips BlueControl is a non-serviceable device that
has an expected life time of at least 3 years in normal intended operation.
Important
Contraindications
Do not use the Philips BlueControl:
- If your skin is burnt or sunburnt.
- If you have a fever.
- If you have a known sun allergy.
- If you are allergic to the surface materials of the Philips BlueControl
device (polycarbonate or polyester/elastane mix).
- If you have any known idiopathic dermatosis such as porphyria,
polymorphic light eruption, chronic actinic dermatitis, actinic prurigo
or solar urticaria that causes photosensitivity.
- If you have any known disease related to low immunity.
- If you have active skin cancer, if you have a history of skin cancer or any
other localised cancer, precancerous lesions or large moles in the areas
to be treated.
- If you are taking photosensitising agents or medications, check the
package insert of your medicine and never use the device if it is stated
that it can cause photo-allergic reactions, photo-toxic reactions or if
you have to avoid sun when taking this medicine.
- If you are on steroids, it makes the skin more susceptible to irritation.
- If you have infections, unhealed tattoos, burns, inammation of hair
follicles, open lacerations, abrasions, herpes simplex, or wounds in the
areas to be treated.
- Avoid treatment of skin areas with tattoos, there is no information
available yet about possible reactions.
ENGLISH 7
- If you have uncontrolled arterial hypertension, a history of stroke,
myocardial infarction, angina pectoris, arteriosclerotic vascular
disease (ASVD).
- If you are pregnant or breastfeeding.
- If you have schizophrenia, borderline syndrome or severe depression.
- If you have any sensory deprivation or have been diagnosed with
shingles or post-herpetic neuralgia, especially in the area to be treated.
- If you have any anatomical pathology or other physical limitation which
would prevent you from placing the Philips BlueControl successfully.
- If you have an active implanted device, such as a cardiac pacemaker,
debrillator, neurostimulator, cochlear implant, or an active drug
administration device.
- If you are in poor general health.
Important safety information
Danger
- Keep the adapter dry.
Warning
- Never immerse the Philips BlueControl in water or any other liquid.
- Never wear the Philips BlueControl while it is charging.
- Never look directly into the light source during use.
- Always check the Philips BlueControl and the adapter for damage
before use. Do not use the Philips BlueControl if the plug, the mains
cord or the Philips BlueControl itself is damaged.
- Do not open or modify the Philips BlueControl.
- If the USB cable or adapter is damaged, you must have it replaced
by Philips, a service centre authorised by Philips or similarly qualied
persons in order to avoid a hazard.
- Do not use the Philips BlueControl in wet and/or hot surroundings,
such as a sauna or bathroom.
- The Philips BlueControl is not intended to be used by persons younger
than 18 and persons with reduced physical, sensory or mental capabilities.
- This is a medical device. Keep the device out of the reach of children.
- Only charge the Philips BlueControl with the USB cable and the
adapter supplied (PR3089).
- The Philips BlueControl is specically designed to treat psoriasis
vulgaris. Do not use it for any other purpose.
- When broken, return the Philips BlueControl to Philips for examination
or repair. Repair by unqualied persons could cause a hazardous
situation for the user.
Caution
- Remove the Philips BlueControl from the strap before you wash
the strap.
- Use, charge and store the Philips BlueControl at a temperature
between 10°C and 35°C and at a relative humidity between 30%
and 90%.
- Read section ‘Contraindications’ to nd out if any apply to you before
you start using the Philips BlueControl.
- To prevent damage to the drum of the washing machine, to other
laundry in the drum or the fabric of the strap, close the velcro
connections and wash the strap in a ne-mesh washing bag.
ENGLISH8
- Always use the Philips BlueControl in the strap with the arm or leg
sling provided, as these strap and slings have been specially designed
for this device.
- Philips BlueControl is intended for daily use. The exact usage time is stated
in chapter ‘Using your Philips BlueControl’, section ‘Treatment schedule’.
Compliance
The Philips BlueControl complies with the standard of basic safety for
medical devices (IEC60601-1) and with the relevant collateral and
particular standards for non-laser light source medical equipment for home
use: EN 60601-1[1], EN 60601-1-11 [3], EN 60601-2-57 [2], and EN
60601-1-2 [4]. Regarding electromagnetic compatibility (EMC) and
electromagnetic elds (EMF), the device should be kept away from radio
frequency (RF) equipment to avoid interference.
General description (Fig. 1)
1 Philips BlueControl
2 LED indicator
3 Micro USB socket
4 On/off button
5 Sensor
6 Strap with Philips BlueControl holder
7 Philips BlueControl securing sling
8 Arm sling
9 Leg sling
Charging
Fully charge the Philips BlueControl before you use it for the rst time.
When fully charged, the Philips BlueControl has enough power for at least
two treatments. It is recommended to charge the Philips BlueControl after
each use. You can charge the Philips BlueControl with the adapter and
USB cable supplied. The adapter and USB cable have an expected life time
of at least 3 years in normal intended operation.When Philips BlueControl
is connected to the charger and in charging mode, the charger PR3089 is
to be considered as a part of the medical equipment.
Note: Treatment is not possible when the Philips BlueControl is charging.
Charging with the adapter
It takes approximately 2 hours to fully charge the Philips BlueControl.
1 Put the mains plug in the adapter and lock it into place.
ENGLISH 9
2 Insert the standard USB plug into the socket on the adapter.
3 Insert the adapter into the wall socket (100V-240V).
4 Insert the micro USB plug into the socket on the Philips
BlueControl.
, When the Philips BlueControl is connected to the mains, it beeps
once and the LED indicator starts ashing green slowly to indicate
that charging has started.
5 When the Philips BlueControl is fully charged, the LED indicator
lights up solid green.
6 Remove the adapter from the wall socket and pull the USB plug out
of the micro USB socket on the Philips BlueControl.
Using your Philips BlueControl
Treatment schedule
Always stick to the recommended treatment schedule. Do not treat
more than once a day.
The Philips BlueControl has been designed for daily use on psoriasis
vulgaris plaques. We recommend treating single, non-overlapping psoriasis
vulgaris plaques only once a day. A single treatment takes approximately
30 minutes, but can be extended to 40 minutes depending on your skin
sensitivity and possible treatment pauses during treatment. For example,
if the infrared sensor senses a too high skin temperature, the treatment
is briey paused for safety reasons. Treatment resumes automatically when
the skin has cooled down. Following this treatment advice ensures that
you do not exceed the daily light dose of 90 J/cm². Blue Light treatment
can be combined with Vitamin D creams. Apply the cream after the
treatment. For other combination treatments with Blue Light, please
consult your doctor. We do not recommend using topical medication,
creams or lotions immediately before and during treatment with the Philips
BlueControl. In case of unpleasant effects such as excessive, non-resolving
skin redness, worsening of plaques or pain, stop treatment immediately
and consult your doctor if necessary. A temporary increased redness of
the treated area after therapy is normal but should diminish.
ENGLISH10
Preparing the Philips BlueControl for use
To place the Philips BlueControl in the strap and to position it correctly
on your body, follow the steps below. The strap has an expected life time
of at least 1 year in normal intended operation.
There are two slings, one shorter sling for your arms and one longer sling
for your legs.
1 Select the arm or leg sling, depending on the area to be treated.
2 Fasten the selected sling with the black Velcro strips.
3 Remove clothing from the area to be treated.
4 Position the strap on top of the psoriasis plaque on your arm or
leg (1). The psoriasis plaque should be visible through the Philips
BlueControl holder in the strap. Make sure the tapered part of
the strap is positioned on the smallest part of your arm or leg.
Wrap the strap around your arm or leg (2).
5 Pull the sling through the ring and fasten it with the Velcro strip
on the end of the strap.
6 Click the Philips BlueControl into the holder in the strap.
The integrated magnets keep the Philips BlueControl in place
if you have attached it properly.
ENGLISH 11
7 Fold the Philips BlueControl securing sling over the Philips
BlueControl (1). Then secure the Philips BlueControl by fastening the
Velcro strip on the end of the sling onto the Velcro strip on the strap (2).
Treatment procedure
1 Press the on/off button to switch on the Philips BlueControl.
Caution: Never look directly into the light source during use.
Do not intentionally touch the sensor in the centre of the Philips
BlueControl when it is switched on.
Do not cover the Philips BlueControl when it is switched on.
2 The Philips BlueControl ashes blue to indicate that it is ready
for treatment. The treatment starts soon after the sensor detects
the psoriasis plaque to be treated.
, The LED indicator lights up solid blue and a sequence of two tones
indicates the Philips BlueControl is in progress.
3 The Philips BlueControl automatically switches off after the
treatment time (approximately 30 minutes) has elapsed.
Interrupting treatment
1 If you want to interrupt the treatment briey, simply remove the
Philips BlueControl or press the on/off button to switch it off.
Note: If you remove the Philips BlueControl or press the on/off button to stop
treatment before the treatment time has elapsed and you do not resume the
treatment within 2 hours, the timer automatically resets. If you resume the
treatment within 2 hours, the countdown of the treatment time wil continue
where it left off.
After treatment
Treatment ends automatically after the treatment time has elapsed, unless
you remove the Philips BlueControl or press the on/off button to stop
treatment earlier.
Note: A sequence of two different tones indicates that the Philips BlueControl
switches off and treatment has ended.
ENGLISH12
1 Pull at the end of the Philips BlueControl securing sling (1)
and lift the sling off the Philips BlueControl (2).
2 Remove the Philips BlueControl from the strap.
3 Loosen the arm or leg sling (1) and remove the strap from
your psoriasis plaque (2).
4 Recharge the Philips BlueControl.
Light and sound signals during use
Overheating signal
Overheating of the device.
1 If the device measures a too high temperature, the Philips
BlueControl switches off for safety reasons.
, The LED indicator lights up solid orange and a long 3-second tone
indicates that the Philips BlueControl switches off.
2 If you try to restart the Philips BlueControl before it has cooled
down, the LED indicator ashes orange for 5 seconds. Cooling down
may take several minutes.
Overheating of the skin.
1 If the device measures a too high skin temperature, the Philips
BlueControl temporarily switches off for safety reasons.
, The LED indicator ashes blue slowly until the skin temperature has
cooled down, the Philips BlueControl switches on again
automatically.
ENGLISH 13
Resetting signal
If the software of the Philips BlueControl no longer responds or if another
unexpected failure occurs, you can reset the Philips BlueControl.
1 Connect the Philips BlueControl to a wall socket with the adapter
or connect it to a USB port of a computer.
2 Press the on/off button for 5 seconds until the LED indicator
switches from green to blue. After the button is released, the LED
indicator shows the following signals in succession: 1. It briey lights
up red and then goes out. 2. It lights up orange and goes out. 3. Then
the LED indicator lights up green briey to indicate that the Philips
BlueControl has been reset and works normally again.
Battery level signals
When you press the on/off button and the LED indicator lights up solid
red and you hear 3 beeps, the battery of the Philips BlueControl is empty.
1 You have to charge the battery before you can start a new
treatment. Charge for at least 40 minutes to be able to complete
one full treatment.
Cleaning
Do not immerse the Philips BlueControl in water or rinse it under
the tap.
Always remove the Philips BlueControl from the strap before you put
the strap in the washing machine to clean it.
Caution: Clean the Philips BlueControl after each treatment to ensure
it continues to function properly.
1 Clean the Philips BlueControl with a damp cloth.
2 Clean the sensor with alcohol and a cotton bud at an ambient
temperature once a week.
3 The strap, the arm sling and the leg sling can be washed in the
washing machine.
Caution: To prevent damage to the drum of the washing machine,
to other laundry in the drum or the fabric of the strap, close the velcro
connections and wash the strap in a ne-mesh washing bag.
Note: Use a gentle cycle and a temperature of 30°C maximum. Dry the strap
and the slings on the air and not in a tumble dryer. Do not iron the strap and
the slings.
ENGLISH14
Environment
- The integrated batteries of the Philips BlueControl contain substances
that may pollute the environment. The batteries cannot be removed.
To ensure proper disposal, take the device to an ofcial collection
point. Staff at the collection point will ensure the batteries are removed
and disposed of in an environmentally safe way.
- Do not throw away the Philips BlueControl with the normal household
waste at the end of its life, but hand it in at an ofcial collection point
for recycling. By doing this, you help to preserve the environment.
Guarantee and support
If you need service or information or if you have a problem, please visit
the Philips website at www.philips.com or contact the Philips Consumer
Care Centre. Its telephone number is: 00800-7445 4775.
Guarantee restrictions
The guarantee does not cover standard wear and tear. The guarantee
becomes invalid if the Philips BlueControl is not used according to the
instructions in this user manual.
Manufacturer’s legal address
Philips Lighting B.V
High Tech Campus 45
5656 AE Eindhoven
The Netherlands
Troubleshooting
This chapter summarises the most common problems you could encounter
with the Philips BlueControl. If you are unable to solve the problem with the
information below, contact the Philips Consumer Care Centre.
Problem Possible cause Solution
I cannot switch on the
Philips BlueControl even
though it is fully charged.
The Philips BlueControl
suddenly switches off during
treatment.
The sensor is dirty. Clean the sensor with alcohol and a
cotton bud (see chapter ‘Cleaning’).
The preset time has elapsed. The Philips BlueControl has been
programmed to switch off automatically
after the treatment time has elapsed.
Problem Possible cause Solution
ENGLISH 15
The Philips BlueControl
suddenly switches off with a
long beep during treatment
and the LED indicator lights
up solid orange.
The Philips BlueControl
suddenly interrupts the
treatment and slowly ashes
blue.
The Philips BlueControl is
switched off with a long
beep and the LED indicator
ashes orange.
The LED indicator lights up
solid orange when I press
the on/off button.
The LED indicator lights
up solid red for 5 seconds
and the Philips BlueControl
beeps 3 times when I press
the on/off button.
The adapter becomes warm
during charging.
The LED indicator does not
ash green when the micro
USB plug is inserted into
the micro USB socket of the
Philips BlueControl.
The sensor is blocked. Check the position of the Philips
The rechargeable battery is
empty.
The temperature of the
Philips BlueControl itself
is too high and the Philips
BlueControl switched off for
safety reasons.
The device measured a too
high skin temperature and
paused the treatment to
allow the skin to cool down.
The Philips BlueControl
was interrupted too many
times during treatment,
for instance because the
sensor sensed a too high
skin temperature or because
maximum treatment time of
40 minutes was exceeded.
The device temperature
is too high and the Philips
BlueControl switched off for
safety reasons.
The rechargeable battery is
empty.
This is normal. No action required.
The adapter is not inserted
or not inserted properly
into the wall socket.
BlueControl in the strap. Make sure the
strap or other clothing does not cover the
sensor. If the sensor is not covered but the
Philips BlueControl still switches off, the
skin temperature is too high. The Philips
BlueControl will switch on automatically
when the skin has cooled down.
The LED indicator ashes red. Charge
the Philips BlueControl (see chapter
‘Charging’).
Let the Philips BlueControl cool down for
10 minutes. Put the Philips BlueControl
back onto your skin and press the on/off
button to resume treatment.
No action required. The treatment will be
resumed automatically after the device
measures a skin temperature in the safe
range.
If this happens a few times, contact Philips.
Let the Philips BlueControl cool down for
10 minutes. Put the Philips BlueControl
back onto your skin and press the on/off
button to resume treatment.
Charge the Philips BlueControl (see
chapter ‘Charging’).
Insert the adapter into the wall socket
properly.
ENGLISH16
Problem Possible cause Solution
The standard USB plug is
not inserted or inserted
properly into the adapter.
The wall socket is not live. Connect another appliance to the same
The Philips BlueControl
becomes warm during use.
Model PSD1111
Rated voltage (V) 100-240
Rated frequency (Hz) 50-60
Rated input (W) 15W
Class Medical device Class IIa
Optical output classication Risk Group 1 according EN 60601-2-57, meaning no
Maximum output of optical peak power density 200mW/cm² during pulsed operation.
Max. daily dose (J/cm²) 90
Battery type 3.7V /rated capacity 5.77 Whr Lithium-ion battery
This is normal. No action required.
Specications
Philips BlueControl is certied as medical non-laser light source equipment.
While in operation it generates Blue Light with the following specication:
risk in normal intended use.
Insert the standard USB plug into the
adapter properly.
wall socket to check if the wall socket is
live. If the wall socket is live, but the Philips
BlueControl does not charge, contact
Philips.
Model PR3089
Input 100-240V AC / 50-60Hz
Output 5V DC / 5W
Operating conditions
Temperature from +10°C to +35°C
Relative humidity from 30% to 90%
ENGLISH 17
Storage conditions
Temperature from -20°C to +35°C
Relative humidity from 30% to 90% (no condensation)
Explanation of symbols
Philips BlueControl
There are several safety warning labels on the device and in the user
manual. Not following these warnings may result in one or more of the
following hazards: electrical shock, skin burn, retinal damage and/or re.
- This symbol is a warning to read the enclosed documents before use
and take all safety precautions required.
- This symbol means: Read the user manual before you start using
the device.
- This symbol means: Do not stare at the light source. Risk Group
1 product (IEC60601-2-57:2011).
- This symbol means: Philips BlueControl is specied as applied part
type BF. B indicates that it is used on the Body and F indicates that
it is Floating from (not connected to) the mains voltage.
ENGLISH18
- This symbol means: Conforms to EC Directives. CE stands for
‘Conformité Européenne’.
- This symbol means ‘Manufactured by’ and provides the address
of the legal manufacturer.
The label on the device states “ONLY PR3089” meaning that the device
may only be charged with the adapter that is supplied in the package.
Usage of other adapters may not be safe and could lead to electrical shock.
The adapter has the following electrical specication: Input 100-240V
AC / 50-60 Hz, output 5V DC / 5W. When charging the device, make sure
that the adapter and the device are positioned in such a way that the
adapter and device can always be disconnected easily.
Adapter
- This symbol indicates that the adapter is double insulated (Class II).
- This symbol indicates that the adapter may only be used indoors.
ENGLISH 19
Strap
- This symbol means: Wash at a temperature of 30°C max.
- This symbol means: Do not bleach.
- This symbol means: Do not tumble-dry.
- This symbol means: Do not iron.
- This symbol means: Do not dry clean.
20
DEUTSCH
Einführung
Lesen Sie diese Bedienungsanleitung aufmerksam durch, bevor Sie
Philips BlueControl verwenden, und bewahren Sie diese für eine spätere
Verwendung auf. Zur Erzielung optimaler Behandlungsergebnisse ist es
erforderlich, das Gerät gemäß dem Behandlungsplan und den Anweisungen
in dieser Bedienungsanleitung anzuwenden.
Liste der Produktcodes
- Kit PSK0101/10
- Gerät PSD1111/10
- Band PSS1110/10
- Adapter PR3089
Verwendungszweck
Philips BlueControl ist ein tragbares medizinisches Gerät mit blauem
LED-Licht zur Linderung der Symptome von Schuppenechte (Psoriasis
vulgaris). Das Gerät lässt sich an den Extremitäten tragen (ausgenommen
Schuppenechte auf den Handächen oder an den Fußsohlen) und ist
für die Verwendung zu Hause vorgesehen, z. B. während leichter Aktivitäten
wie Fernsehen oder Lesen. Das Gerät wird mittels eines Haltebandes an
der betreffenden Stelle positioniert. Betrieben wird das Gerät über einen
Akku. Philips BlueControl sollte nur von Personen über 18 Jahren und
gemäß den Sicherheitshinweisen und den Anweisungen in dieser
Bedienungsanleitung verwendet und bedient werden. Philips BlueControl
ist ein nicht auswechselbares Gerät, das bei normaler Verwendung eine
erwartete Lebensdauer von mindestens 3 Jahren hat.
Wichtig
Gegenanzeigen
Verwenden Sie Philips BlueControl nicht in folgenden Situationen:
- Wenn Sie Hautverbrennungen oder einen Sonnenbrand haben.
- Wenn Sie Fieber haben.
- Wenn Sie eine bekannte Sonnenallergie haben.
- Wenn Sie allergisch auf die Oberächenmaterialien des Philips
BlueControl-Geräts reagieren (Polycarbonat- bzw. Polyester-/
Elastanmischung).
- Wenn Sie unter einer idiopathischen Hauterkrankung, wie z. B.
Porphyrie, polymorphen Licht-Dermatose, chronischer aktinischen
Dermatitis, aktinischer Prurigo oder Lichturtikaria, die
Lichtempndlichkeit verursacht, leiden.
- Wenn Sie unter einer Krankheit im Zusammenhang mit einer
Immunschwäche leiden.
- Wenn Sie unter aktivem Hautkrebs leiden oder in der Vergangenheit an
den zu behandelnden Hautpartien unter Hautkrebs oder einer anderen
Krebsart gelitten haben; das Gleiche gilt bei präkanzerösen Läsionen
und großen Muttermalen.
- Wenn Sie fotosensibilisierende Medikamente einnehmen, prüfen Sie
deren Beipackzettel, und verwenden Sie das Gerät auf keinen Fall, wenn
als Nebenwirkungen fotoallergische oder fototoxische Reaktionen
auftreten können oder Ihre Haut während der Einnahmezeit der
Medikamente nicht direktem Sonnenlicht ausgesetzt werden darf.
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