PSK0101 - Light therapy PHILIPS - Free user manual and instructions

USER MANUAL PSK0101 PHILIPS

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PSD1111/10

White Philips medical device with a blue circular button and a small blue dot on the lid (no text or symbols visible on the device body)

User manual

PHILIPS

Illustration of an open book with a grid pattern on the left and a closed page on the right (no text or symbols)

ENGLISH 6

DEUTSCH 20

FRANÇAIS 35

NEDERLANDS 49

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 fixation 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, inflammation 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.

• 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, defibrillator, 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 qualified 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 specifically 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 unqualified 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 find 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 fine-mesh washing bag.

• 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 fields (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 first 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.

Diagram showing a blue electrical plug inserted into a plastic housing with a blue arrow indicating the process (no text or symbols present)

1 Put the mains plug in the adapter and lock it into place.

Diagram of a device with a blue arrow pointing upward, indicating a process or operation (no text or symbols present)

2 Insert the standard USB plug into the socket on the adapter.

Illustration of a blue electrical plug connected to a wall-mounted socket (no text or symbols)

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 flashing 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 briefly 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.

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.

Illustration of a blue mechanical component with two directional arrows indicating movement or force (no text or symbols)

Illustration of a blue mechanical component being lifted by a curved cable, with no visible text or symbols.

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

Line drawing of a circular device with a blue arrow pointing to a small component on the side (no text or symbols)

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.

Line drawing of a robotic vacuum cleaner with a blue star-shaped patch on the top (no text or symbols)

2 The Philips BlueControl flashes 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 briefly, 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 will 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.

1 Pull at the end of the Philips BlueControl securing sling (1) and lift the sling off the Philips BlueControl (2).

Illustration of a blue spherical object being lifted by a curved rod, with an upward arrow indicating motion (no text or symbols)

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

Line drawing of a microwave oven with a circular orange lid and two side slots (no text or symbols)

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 flashes orange for 5 seconds. Cooling down may take several minutes.

Overheating of the skin.

Line drawing of a robotic vacuum cleaner with a blue star-shaped sensor on the lid (no text or symbols)

1 If the device measures a too high skin temperature, the Philips BlueControl temporarily switches off for safety reasons.
The LED indicator flashes blue slowly until the skin temperature has cooled down, the Philips BlueControl switches on again automatically.

graph TD
    A["Red Node"] --> B["Orange Node"]
    B --> C["Green Node"]
    D["Red Node"] --> E["Red Node"]
    E --> F["Red Node"]

Line drawing of a robotic vacuum cleaner with a red circular patch on the lid (no text or symbols)

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 briefly lights up red and then goes out. 2. It lights up orange and goes out. 3. Then the LED indicator lights up green briefly 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.

Illustration of a hand cleaning a blue cloth over a bowl (no text or symbols)

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 fine-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.

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 official collection point. Staff at the collection point will ensure the batteries are removed and disposed of in an environmentally safe way.

Symbol of a trash bin crossed with no text or numbers, representing waste sorting or disposal (no text present)

- Do not throw away the Philips BlueControl with the normal household waste at the end of its life, but hand it in at an official 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 sensor is dirty. Clean the sensor with alcohol and a cotton bud (see chapter ‘Cleaning’).
The Philips BlueControl suddenly switches off during treatment.	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

	The sensor is blocked. Check the position of the Philips 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 rechargeable battery is empty.	The LED indicator flashes red. Charge the Philips BlueControl (see chapter ‘Charging’).
The Philips BlueControl suddenly switches off with a long beep during treatment and the LED indicator lights up solid orange.	The temperature of the Philips BlueControl itself is too high and the Philips BlueControl switched off for safety reasons.	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.
The Philips BlueControl suddenly interrupts the treatment and slowly flashes blue.	The device measured a too high skin temperature and paused the treatment to allow the skin to cool down.	No action required. The treatment will be resumed automatically after the device measures a skin temperature in the safe range.
The Philips BlueControl is switched off with a long beep and the LED indicator flashes orange.	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.	If this happens a few times, contact Philips.
The LED indicator lights up solid orange when I press the on/off button.	The device temperature is too high and the Philips BlueControl switched off for safety reasons.	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.
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 rechargeable battery is empty.	Charge the Philips BlueControl (see chapter ‘Charging’).
The adapter becomes warm during charging.	This is normal. No action required.
The LED indicator does not flash green when the micro USB plug is inserted into the micro USB socket of the Philips BlueControl.	The adapter is not inserted or not inserted properly into the wall socket.	Insert the adapter into the wall socket properly.

Problem Possible cause Solution

	The standard USB plug is not inserted or inserted properly into the adapter.	Insert the standard USB plug into the adapter properly.
	The wall socket is not live. Connect another appliance to the same 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.
The Philips BlueControl becomes warm during use.	This is normal. No action required.

Specifications

Philips BlueControl is certified as medical non-laser light source equipment. While in operation it generates Blue Light with the following specification:

Model PSD1111

Rated voltage (V) 100-240
Rated frequency (Hz) 50-60
Rated input (W) 15W
Class Medical device Class IIa
Optical output classification Risk Group 1 according EN 60601-2-57, meaning no risk in normal intended use.
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

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%

Storage conditions

Temperature from -20^ to +35^

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 fire.

- This symbol is a warning to read the enclosed documents before use and take all safety precautions required.

Blue circular icon with a white human figure using a laptop (no text or symbols)

- This symbol means: Read the user manual before you start using the device.

Yellow triangular warning sign with black starburst symbol (no text)

- This symbol means: Do not stare at the light source. Risk Group 1 product (IEC60601-2-57:2011).

Simple black-and-white icon of a walking human figure inside a square frame (no text or symbols)

- This symbol means: Philips BlueControl is specified 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.

- This symbol means: Conforms to EC Directives. CE stands for 'Conformité Européenne'.

Abstract black-and-white graphic of a factory chimney with mountain silhouettes (no text or symbols)

- 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 specification: 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.

Simple line drawing of a house with chimney (no text or symbols)

Adapter

- This symbol indicates that the adapter is double insulated (Class II).

- This symbol indicates that the adapter may only be used indoors.

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.

Einführung

Diagram showing a blue electrical plug inserted into a terminal block with a blue arrow indicating direction (no text or symbols present)

Diagram of a device with a blue arrow pointing upward, indicating a force or direction (no text or symbols present)

Illustration of a blue electrical plug connected to a wall-mounted socket (no text or symbols)

Diagram of a blue car seatbelt with a blue arrow indicating force or movement (no text or symbols)

Line drawing of a device casing with a blue arrow pointing to a circular component (no text or symbols)

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Diagram of a mechanical device with a blue component and a gray handle, showing an upward arrow (no text or symbols)

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Line drawing of a robotic vacuum cleaner with a blue star-shaped patch on the top (no text or symbols)

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Akkuzustandsignale

Illustration of a hand cleaning a blue cloth over a bowl (no text or symbols)

Blue circular icon with a white silhouette of a person using a laptop (no text or symbols)

Yellow triangular warning sign with black starburst symbol (no text)

Simple black-and-white icon of a walking human figure inside a square frame (no text or symbols)

Abstract black-and-white graphic of a factory chimney with mountain silhouettes (no text or symbols)

Simple line drawing of a house with chimney (no text or symbols)

Ladegerät

Diagram of a blue electrical plug inserted into a terminal block with a blue arrow indicating direction (no text or symbols)

Diagram of a device with a blue arrow pointing upward, indicating a process or connection (no text or symbols present)

Illustration of a blue electrical plug connected to two white electrical outlets (no text or symbols)

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Illustration of a blue mechanical component being adjusted with a rope, showing motion direction (no text or symbols)

2 Retirez le dispositif Philips BlueControl de la sangle.

Signal de surchauffe

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Symbol of a trash bin crossed with a diagonal line, representing no waste or discharge (no text or numbers present)

Blue circular icon with a white human figure using a laptop (no text or symbols)

Yellow triangular warning sign with black starburst symbol (no text)

Simple black-and-white icon of a walking human figure inside a square frame (no text or symbols)

Abstract black-and-white graphic of a factory chimney (no text or symbols)

Simple line drawing of a house with chimney (no text or symbols)

Diagram of a blue electrical plug inserted into a plastic housing with a blue arrow indicating the insertion direction (no text or symbols present)

Diagram of a device with a blue arrow pointing upward, indicating a process or connection (no text or symbols present)

Illustration of a blue electrical plug connected to two wall-mounted switches (no text or symbols present)

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Line drawing of a robotic vacuum cleaner with a star-shaped sensor on the lid (no text or symbols)

graph TD
    A["Red Node"] --> B["Orange Node"]
    B --> C["Green Node"]
    D["Red Node"] --> E["Red Node"]
    E --> F["Green Node"]

Line drawing of a robotic vacuum cleaner with a red circular patch on the lid (no text or symbols)

Illustration of a hand cleaning a blue cloth over a circular object (no text or symbols)

Symbol of a waste bin with crossed lines indicating no waste, and a solid black rectangle below (no text or labels)

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Yellow triangular warning sign with black starburst symbol (no text)

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Abstract black-and-white graphic of a factory or industrial structure with triangular peaks and a tall chimney (no text or symbols)