ESPADA™

RISKS

1. Overheating:

• May cause injury, discomfort - Stop use immediately, allow device to cool.

2. Inadvertent light contact with eyes:

• May cause discomfort - Use caution to prevent light source from shining directly into the eyes

3. Photosensitivity:

• May cause redness, inflammation and irritation - Contact your physician if you think you may be having a photosensitive reaction.

4. Adverse reaction with certain medications or supplements:

• May cause redness, inflammation and irritation - Please read Contraindications before use.

5. Contact with neck in users with thyroid conditions:

• Possible stimulation of growth - Please read Contraindications before use.

6. Incorrect identification of “mild to moderate inflammatory acne”:

Attempting to use on more severe forms of acne or other skin conditions may cause adverse results - Please read Intended Use before starting.

WARNINGS

• Consult your dermatologist prior to using the ESPADA™ if you have medical concerns.
• Do NOT use the device for severe, nodular or cystic acne.
• Do NOT use the device on or come in contact with injured skin or skin that has undergone surgery.
• Do NOT use the device on beauty spots/moles, warts, ingrown hairs or irritated skin.
• Do NOT use device in and around the eye and lip area.
• Do NOT use the device if you are particularly sensitive to light.
• Do NOT use the device if you have had sunburn within the past 2 weeks.
• Do NOT apply the treatment to a spot more than 3 times daily. Any more often than this could lead to skin burns or injuries. Leave a minimum time of 4 hours between each treatment.
• Do NOT use device longer than 2 minutes on one blemish. Overuse can lead to skin injury.
• Excessive use beyond the recommended treatment time may cause the device to become warm. The device’s temperature will not go beyond 40°C if used at room temperature, but may cause discomfort or prolonged redness.
• If after using device you experience a worsening of the skin (skin feels tense, uncomfortable, irritated, red, burning, etc.), undesired side effects or prolonged redness, stop using the device and consult your doctor. However, a temporary, mild reddening after application is normal.
• Never look directly at the blue light as this could lead to eye injury.
• Do NOT let children use or play with the ESPADA™. The ESPADA™ has not been tested on children and may cause skin injury such as temporary redness or pigment changes (hypoand hyperpigmentation) or affect their eyes.
• Proper supervision and instructions for safe use should be given to those with reduced physical and mental abilities.
• Do NOT share the ESPADA™ with other people. Sharing the device could transfer bacteria from one person to another.
• Do NOT use the device if it is visibly damaged, and never attempt to open or repair the device. Doing this could result in damage or malfunction to the device, serious eye or skin injury, fire, or possibly fatal electric shock.
• Pregnant or breastfeeding women should not use this device.
• Those who have had a migraine in the past two years should not use this device.
• Do NOT use over a thyroid gland as it may result in growth stimulation.
• If you are taking drugs or steroids for pain or skin conditions that cause light sensitivity, using this device may result in a photosensitive reaction.
• Do not use over or near a steroid injection received within the last six months. Doing so may result in a photosensitive reaction.
• In order to prevent fire or serious burns, immediately turn off device if it begins to overheat.
• Keep away from aerosol products.

CONTRAINDICATIONS

• Do NOT use if you have a history of light triggered seizures.
• Do NOT use this device over a suspicious or cancerous lesion as it can delay proper medical treatment.

TYPICAL CHARACTERISTICS OF POTENTIALLY CANCEROUS LESIONS INCLUDE:

• Asymmetry: one half of the abnormal skin area is different than the other half
• Borders: irregular borders
• Color: varies from one area to another with shades of tan, brown, or black (sometimes white, red, blue)
• Diameter: usually (but not always) larger than 6 mm in size (diameter of a pencil eraser)
• Bleeding: Any skin growth that bleeds or will not heal

Emissions test:

1. Actinic UV:

• Risk Group 2 - UV emitted from this device may result in eye or skin irritation

2. Near UV:

• Risk Group 2 - UV emitted from this device may result in eye irritation

3. Blue-light:

• Risk Group 1 - Not required.

4. Retinal Thermal:

• Exempt Group - Not required

5. Retinal Thermal, weak visual stimulus:

• Exempt Group - Not required

6. Corneal/ Lens IR:

• Exempt Group - Not required

Spectral irradiance: 0.5lm. Maximum output of optical radiation: 75mW

ENVIRONMENTAL REQUIREMENTS:

1. Temperature

• Operation: 5 to 40 °C
• Storage and Transport: -10 to 50 °C

2. Humidity:

• Operation: 15 to 93% RH, non-condensing
• Storage and Transport: <=93% RH, non-condensing

3. Pressure:

• Operation: 700 - 1060hPa
• Storage and Transport: 700 - 1060hPa

Spectral irradiance: 0.5lm. Maximum output of optical radiation: 75mW

Register warranty

To activate your 2-Year Limited Warranty register through the FOREO app, or visit foreo.com/product-registration for more information.

2-year limited warranty

FOREO warrants this device for a period of TWO (2) YEARS (except in countries where national law requires longer minimum guarantee) after the original date of purchase against defects due to faulty workmanship or materials arising from normal use of the device. The warranty covers working parts that affect the function of the device. It does NOT cover cosmetic deterioration caused by fair wear and tear, or damage caused by accident, misuse, or neglect. Any attempt to open or take apart the device (or its accessories) will void the warranty.

If you discover a defect and notify FOREO during the warranty period, FOREO will, at its discretion, replace the device free of charge. Claims under warranty must be supported by reasonable evidence that the date of the claim is within the warranty period. To validate your warranty, please keep your original purchase receipt together with these warranty conditions for the duration of the warranty period.

To claim your warranty, you must log in to your account at www.foreo.com and select the option to make a warranty claim. Shipping costs are nonrefundable. This undertaking is in addition to your statutory rights as a consumer and does not affect those rights in any way.

Disposal information

Disposal of old electronic equipment (applicable in the EU and other European countries with separate waste collection systems).

The crossed-out dustbin symbol indicates that this device should not be treated as household waste, but rather be brought to the appropriate collection point for recycling of electrical and electronic equipment. By ensuring this device is disposed of correctly, you will help prevent the potential negative consequences for the environment and human health which could be caused by inappropriate waste handling of the product. The recycling of materials will also help conserve natural resources.

For more information about the recycling of your device, please contact your local household waste disposal service or your place of purchase.

BATTERY CARE: It is recommended to regularly use the device to ensure proper performance. The ESPADA™ should be fully charged at least every 3 months to maintain the battery.

GUIDANCE AND MANUFACTURER’S DECLARATION:
ELECTROMAGNETIC EMISSIONS & IMMUNITY: Medical electrical equipment requires special precautions regarding EMC and must be installed and put into service according to EMC information provided in this document. Portable and mobile RF communications equipment can affect the medical electrical equipment. This declaration currently applies to the ESPADA™ device.

GUIDANCE AND MANUFACTURER’S DECLARATION: 

ELECTROMAGNETIC EMISSIONS: The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

DISCLAIMER: Users of this device do so at their own risk. Neither FOREO nor its retailers assume any responsibility or liability for any injuries or damages, physical or otherwise, resulting directly or indirectly from the use of this device. Furthermore, FOREO reserves the right to revise this publication and to make changes from time to time in the contents thereof without obligation to notify any person of such revision or changes.

CAUTION: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

Model may be changed for improvements without notice.

Emissions test:

1. RF emissions CISPR 15

• Compliance: Group 1
• Electromagnetic environment-guidance: The device is supplied by very low voltage Li-on battery. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

2. RF emissions CISPR 11

• Compliance: Group 2
• Electromagnetic environment-guidance: The device does not need to use an AC adapter to charge, so it’s radiated power is very low.

WARNINGS:

• This device should not be used adjacent to other high field equipment or areas. If adjacent use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
• This device should not be used adjacent to high-frequency equipment. If the device is adjacent to a short wave device or microwave device, the device’s output may be unstable.
• The use of accessories other than those specified for the device is not recommended as it may result in increased emissions or decreased immunity of the device.
• The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.

Immunity test:

1. Electrostatic Discharge(ESD) IEC 61000-4-2

• IEC60601-1-2: ± 6kV contact , ± 8kV air
• Compliance level: ± 6kV contact , ± 8kV air
• Electromagnetic environment guidance: Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

2. Electromagnetic field susceptibility IEC61000-4-3

• IEC60601-1-2: 3V/m
• Compliance level: 3V/m
• Electromagnetic environment guidance: Because it is not life-supporting equipment, it does not use only shield location.

3. Power frequency (50/60 HZ) Magnetic field IEC 61000-4-8

• IEC60601-1-2: 3A/m
• Compliance level: 3A/m
• Electromagnetic environment guidance: Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

4. Radiated emission

• IEC60601-1-2: 40 dBμV/M (3M) , 30MHZ ~ 230MHZ , 47 dBμV/M (3M) , 230MHZ~ 1000MHZ
• Compliance level: 40 dBμV/M (3M) , 30MHZ ~ 230MHZ , 47 dBμV/M (3M) , 230MHZ~ 1000MHZ
• Electromagnetic environment guidance: In all frequencies, the radiated strength is less than limited value.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless), telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ESPADA™ device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.

NOTES: These guidelines may not apply in all situations. Electromagnetic propagation is affected.

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE DEVICE 

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communication equipment.

1. Rated maximum output Power of transmitter: 0.01

a) Separation distance according to frequency of transmitter: 30MHZ to 80MHZ => d = 1.2√p

b) Separation distance according to frequency of transmitter: 80MHZ to 800MHZ d = 1.2√p => 0.12

c) Separation distance according to frequency of transmitter: 800MHZ to 1000MHZ d = 2.3√p => 0.23

2. Rated maximum output Power of transmitter: 0.1

a) Separation distance according to frequency of transmitter: 30MHZ to 80MHZ => d = 1.2√p

b) Separation distance according to frequency of transmitter: 80MHZ to 800MHZ d = 1.2√p => 0.38

c) Separation distance according to frequency of transmitter: 800MHZ to 1000MHZ d = 2.3√p => 0.73

3. Rated maximum output Power of transmitter: 1

a) Separation distance according to frequency of transmitter: 30MHZ to 80MHZ => d = 2.3√p

b) Separation distance according to frequency of transmitter: 80MHZ to 800MHZ d = 1.2√p => 1.2
c) Separation distance according to frequency of transmitter: 800MHZ to 1000MHZ d = 2.3√p => 2.3

4. Rated maximum output Power of transmitter: 10

a) Separation distance according to frequency of transmitter: 30MHZ to 80MHZ => 3.8

b) Separation distance according to frequency of transmitter: 80MHZ to 800MHZ d = 1.2√p => 3.8

c) Separation distance according to frequency of transmitter: 800MHZ to 1000MHZ d = 2.3√p => 7.3

5. Rated maximum output Power of transmitter: 100

a) Separation distance according to frequency of transmitter: 30MHZ to 80MHZ => 12

b) Separation distance according to frequency of transmitter: 80MHZ to 800MHZ d = 1.2√p => 12

c) Separation distance according to frequency of transmitter: 800MHZ to 1000MHZ d = 2.3√p => 23

For transmitters rated at a maximum output not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation application to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture.

NOTES: These guidelines may not apply in all situations. Electromagnetic propagation is affected.