Therabody 15225120 Mode d'emploi

Marque: Therabody

Modèle: 15225120

Catégorie: Moniteurs de fréquence cardiaque

Taper: Mode d'emploi

TheraFace PRO

EN/DE/FR/ES

TABLE OF CONTENTS

Language

EN 2- 21

DE 22-41

FR 42-61

ES 62-81

Product Overview

TheraFace PRO

An advanced solution for better facial wellness.

The TheraFace PRO is a 4-in-1 handheld device that takes facial wellness to the next level by helping to reduce tension,

relax facial muscles, and achieve healthier-looking skin by gently stimulating the face. It includes microcurrent, blue, red,

and red+infrared light LED, and cleansing treatments, allowing you to customize your facial therapy in one easy-to-use

versatile device. Use the variety of treatment rings to help lift, tone, rejuvenate, and deep clean. The TheraFace PRO is

your all-in-one solution for optimal health and wellness for the face.

Intended Use

Percussive Therapy

The TheraFace PRO is intended to help reduce tension, relax facial muscles, and achieve more beautiful skin by gently

stimulating the face. The variety of treatment rings are intended to help lift, tone, rejuvenate, and deep clean.

Percussive therapy, now optimized for the face. Facial massage to reduce tension and relax facial muscles.

Microcurrent Ring Cleansing Ring

Microcurrent firms and tightens the skin. Microcurrent

improves muscle tone and contour in the face/neck

0 Magnetic connection to the device and can be

removed by pulling

0 The Microcurrent treatment is delivered through

the Microcurrent Ring

A primer gel intended to be used with the

TheraFace PRO device prior to starting

the microcurrent treatment to ensure the

treatment is delivered safely and effectively

Cleansing removes facial build up of dirt, oil, and debris

0 Magnetic connection to the device and can be

removed by pulling

0 All cleansing is delivered through the Cleansing Ring

TheraOneTM Conductive Gel

LED Ring: Blue/Red/Red+IR LED Ring: Red + Infrared Light

Red + Infrared Light is intended to reduce periorbital

wrinkles (the wrinkles around the eyes) and is shown to

increase the body’s natural healing process

LED Ring: RED Light

Red Light is intended to reduce periorbital wrinkles

(the wrinkles around the eyes)

LED Ring: Blue Light

Blue Light is intended to reduce mild to

moderate acne

*Blue Light is not intended to treat or reduce severe acne

Example of Periorbital Wrinkles

Example of Mild Acne Example of Moderate Acne

Example of Severe Acne*

0 Magnetic connection to the device and can

be removed by pulling

0 The LED treatment is delivered through the

LED Ring

EN Getting To Know Your TheraFace PRO Device

Percussive Therapy Button

0 Controls the Percussive Attachment

Ring Button

0 Controls the Attachment Ring

Attachment Ring

0 Magnetic connection to the device and

can be removed by pulling

0 All the Attachment Rings have only one

correct position

Percussive Therapy Attachments

0 Magnetic connection to the device and

can be removed by pulling

0 All the Attachment Rings have only one

correct position

Power Button

0 Powers the device ON / OFF

Flat - General use for the entire

face, neck and chest

Cone - More precise treatment

for targeted areas such as around

the eyes, nasolabial lines and

pressure points

Micropoint - Maximize

circulation for larger areas such as

the forehead, cheeks and chest

Hot and Cold Rings

(sold separately)

0 Magnetic connection to the device

and can be removed by pulling

0 Delivers the option of 3 Cold and

3 Hot settings

Getting Started

Push and hold the ON/OFF button to power on the

device and the OLED screen will turn on.

Powering on the TheraFace PRO device

1. Start with a clean, dry face

2. Select and attach your desired

attachment ring

3. Turn on the device

4. Choose your settings

5. Get started

Basic getting started steps:

Push and hold the ON/OFF button again to switch the

device off and the OLED screen will be off.

Switching O

If the device is not manually powered off by pressing the Power button, the

device will automatically shut off after 10 minutes of inactivity.

Automatic Shut O Note: Make sure you turn off

the power on the device before

removing the rings.

EN B. LED Treatment

1. The LED ring has 3 light therapy wavelength options: red, blue and

red+infrared.

2. To start using the LED therapy mode, attach the LED ring to the

TheraFace PRO device.

3. Turn ON the TheraFace PRO device by pressing the Power Button

for 2 seconds.

4. Then, turn ON the LED ring by pressing the Attachment Ring button.

5. To toggle between light options (blue, red and red+infrared), press

the Attachment Ring button again.

6. The TheraFace PRO LED ring has a proximity sensor system, and will

only reach full light intensity (brightness) once the device is placed at

the right distance from your face (0.5 inches), reducing glare in the

interim. Avoid direct skin contact.

7. To turn off the LED ring, toggle to the Red+IR light mode and

press the Attachment Ring Button one more time or power off the

TheraFace PRO device by pressing the Power Button for 2 seconds.

Warning: Do not place the LED Ring directly on the skin. Keep the LED

Ring approximately 0.5 inches away from the skin.

Using the TheraFace PRO

Start by washing your face completely and rinse twice to remove residue.

Allow skin to dry completely before starting treatment. Be sure to visit

therabody.com for treatment protocols and instructional videos.

A. Percussive Therapy Feature

1. Select and attach the desired percussive therapy attachment

2. Once attached to the TheraFace PRO, turn ON the TheraFace PRO

device by pressing the Power Button for 2 seconds.

3. Turn on the percussive feature by pressing the percussive button once.

4. To toggle between the 3 speed options (1750, 2100 and 2400 rpm), press

the percussive button again.

5. To stop the percussive treatment, press the percussive button a third time.

Note: • Can be combined with Hot and Cold Rings* - (*Hot and Cold Rings sold separately)

• Cannot be combined with the Microcurrent attachment or with the LED ring

Note: The TheraFace PRO device

will make a beeping sound every 15

seconds. This will help you track the

time within each treatment and will

also inform you if a treatment has

been disconnected or is completed.

• 1 beep = timed feedback every 15 sec so you

can time their protocols better

• 2 beeps = the LED, Microcurrent, Hot, or Cold

treatment has been accidentally disconnected

• 3 beeps = the LED, Microcurrent, Hot, or Cold

treatment is over

B. LED Treatment C. Microcurrent Treatment

1. Remove any percussive therapy attachment before attaching the

Microcurrent Ring.

2. Prior to starting the microcurrent treatment, apply the TheraOne™

Conductive Gel to your clean, dry face or treatment area to ensure

the treatment is delivered correctly.

3. Attach the Microcurrent Ring to the TheraFace PRO device.

4. Once attached to the TheraFace PRO, turn ON the TheraFace PRO

device by pressing the Power Button for 2 seconds.

5. Turn on the microcurrent treatment by pressing the ring button once.

6. To adjust the intensity level to your comfort, press the ring button once

to toggle between the 3 intensity options.

7. To stop the microcurrent treatment, press the ring button a third time.

Warning: When using the TheraFace PRO with the Microcurrent Ring, a

microcurrent primer is required. Do NOT use the Microcurrent Ring on the midline

of the neck or eye area.

PRO Tip: When using the Microcurrent Ring, slowly glide the device using light

to medium pressure, keeping both spheres on the face at once. A microcurrent

protocol of 5-8 minutes can be completed once per 24-hour period. Be sure to

visit therabody.com for treatment protocols and instructional videos.

The TheraOne™ Conductive Gel is a primer intended to be used with the

TheraFace PRO device prior to starting the microcurrent treatment to ensure

the treatment is delivered safely and eectively.

D. Microcurrent Primer: TheraOne Conductive Gel

Directions:

1. Start with a clean, dry face.

2. Apply a mask-like layer of the conductive gel to all treatment areas

of the face and neck.

3. Following treatment with the microcurrent ring, rinse off and apply

your favorite moisturizer.

Note: • There is a preset shut off time of 8 minutes

• Cannot be combined with the percussive therapy attachments

• While the Microcurrent Ring will work with any conductive gel, we

recommend the TheraOne™ Conductive Gel if available in your market.

1. Tone: Use one cotton pad with toner applied sweeping gently

across the face, avoiding the eye area and concentrating on the

nose, nasal fold, and chin

2. Serum: Apply serum

3. Moisturizer: Apply moisturizer

4. SPF: Apply SPF only in the morning or daytime hours

If you already use a toner, serum, moisturizer, and/or SPF, then apply in

this order following the completion of any TheraFace PRO protocol:

After Skin Treatment

Clean your face with a warm, damp washcloth.

Device Maintenance

The following maintenance instructions are important to ensure that

your device continues to work as it was designed. Failure to follow these

instructions may cause your device to stop working.

Care and Cleaning

Visually inspect the TheraFace PRO device and attachment rings for any obvious

signs of debris build-up. Wipe your device and attachment rings down with a damp

cloth or alcohol-free cleansing wipe. After cleaning, allow the device and attachment

rings to dry thoroughly before storing or beginning another treatment protocol. A

properly cleaned device should have no visible signs of debris or moisture.

Note: This product is not waterproof, only clean with a damp cloth or alcohol-free cleansing

wipe by wiping the device and attachment rings. Do not submerge the device in water or clean

it under running water (other than the Cleaning Ring). Do not allow the device to come into

contact with any corrosive solutions, which would damage appearance and function. Store

the device in a cool and dry place (Temperature: 0°C/32°F - 40°C/104°F Relative humidity:

10~95% RH). Do not store the device or battery where temperatures may exceed 40°C/104°F,

such as in direct sunlight or in a vehicle.

TheraFace PRO Device After Care & Cleaning

Warnings: Use only as directed. Avoid eye contact. Do NOT use the on the midline

of the neck. Prior to starting the microcurrent treatment, test by applying a small

amount of the TheraOne Conductive Gel on a small patch of skin rst. Skin may

absorb gel during microcurrent session; reapply if needed to ensure even glide of

device on the skin.

Charging the TheraFace PRO

• The TheraFace PRO is USB-C enabled with the connector at the bottom of the

device.

• The TheraFace PRO includes a USB-C to USB-A cable.

• You can plug the device into any standard USB adapter.

• The TheraFace PRO allows for fast-charging if charged with a USB-C adapter.

Note: Make sure the charger is from a certified manufacturer and it hasn’t suffered any

structural damage. The TheraFace PRO device will not work while charging.

TheraFace PRO Warnings and Guidance

(Precautions and Contraindications)

Background

This device is intended to be used on the face, neck, and upper chest regions of

the body. If you have any specific medical conditions or concerns, please consult

your physician before using this product. There will be times when it is advisable

to modify how devices are used (precautions) or times when it is not appropriate to

use certain devices (contraindications). The following document highlights these

for each modality or treatment attachment included with the TheraFace PRO

device as of the date of printing. For up-to-date information, please visit us online.

Important Safety Information

General TheraFace PRO Use

Read the full Warnings and Guidance prior to using the TheraFace PRO.

This device is contraindicated against and should not be used by or on anyone with a history

of epilepsy, seizures or cardiopathy. The TheraFace PRO is not recommended for anyone

with an electronic implanted device (such as a pacemaker), cardiac arrhythmia, tumors, or

acute episodes of inflammatory diseases. The device is not recommended for those who have

arteriosclerosis, thromboses or implants in the body region being treated. Dental implants

should be firmly anchored before using the device. Do not use the device on the eyes, eyelids,

or the area immediately surrounding the eye (Periorbita area). The device should not be used

if you have dark brown or black spots, such as large freckles, birthmarks, moles or warts, on the

area to be treated. The device is not recommended if you have eczema, psoriasis, lesions, open

wounds or active infections other than mild to moderate acne, such as cold sores, in the area to

be treated. Wait for the infected area to heal before using the device. The device should not be

used if you have abnormal skin conditions caused by diabetes or other systemic or metabolic

diseases. It is not recommended to use this device if you have a history of herpes outbreaks

in the area of treatment, unless you have consulted with your physician and have received

preventive treatment before using the device. Please consult your physician prior to use if you

are pregnant and/or nursing.

Please consult your physician prior to use if you are pregnant and/or nursing.

Immediately stop using the device at the first sign of discomfort.

The device is not recommended for anyone under the age of 18 without adult supervision

and should be kept out of reach of children. If you have any medical concerns, are taking

any medications that cause light sensitivity, or have had any facial surgery or other surgical

procedures, please consult your doctor before using the device.

EN Microcurrent Ring Attachment

These recommendations are derived from consultation with

medical experts and the published research in regards to

precautions and contraindications and are as of the date of

printing. For up-to-date information, please visit us online.

When using the device with the microcurrent treatment,

a microcurrent conductive gel primer is required. Prior to

starting the microcurrent treatment, test by applying a small

amount of the conductive gel on a small patch of skin.

Precautions

• Recent injury, surgery, or facial treatment such as neurotoxin,

dermal filler, microneedling, laser, and/or chemical peel until

skin has fully healed

• Do not use during a breakout from Herpes Simplex Virus

• Do not use over facial hair; facial hair must be shaved prior to

use as hair can interfere with the conductivity

• Do not use if you suffer from any heart condition

• Do not use directly over center of neck (bone), specifically

avoiding the thyroid

• Do not use on breast area

• Do not use across your chest

• Do not use on groin area

• Do not use directly on the eyes, eyelids, or the area immediately

surrounding the eye (Periorbita area).

• Do not apply to broken skin

• Do not use on children

Contraindications

The following are circumstances where the potential risks

may outweigh the benefits. Consult a medical professional

before use.

• Skin rash, open wounds, blisters, local tissue inflammation,

infections, bruises, or tumors

• Pacemaker or other implanted electronic devices

• Epilepsy

• Pregnancy

• Cancer/tumors

• Thrombosis

• Phlebitis

• Metal plates or pins in the application area

• Implanted defibrillators/ stimulators

LED Ring Attachment (Red

LED, Red+IR LED, and Blue LED

Therapies)

These recommendations are derived from consultation with

medical experts and the published research in regards to

precautions and contraindications as of the date of printing.

For up-to-date information, please visit us online.

Precautions

• Recent injury, surgery, or facial treatment such as neurotoxin,

dermal filler, microneedling, laser, and/or chemical peel until skin

has fully healed.

• Current breakout from Herpes Simplex Virus

• For facial hair: Use LED over facial hair, following the pattern of

hair growth (typically in a downward motion)

• Do not apply directly to the eyeball/eyelid

• Do not apply to broken skin

• Do not apply retinol before use of red LED light

Contraindications

The following are circumstances where the potential risks may

outweigh the benefits. Consult a medical professional before use.

• Skin rash, open wounds, blisters, local tissue inflammation,

infections, bruises, or tumors

• Pregnancy/nursing

• Abnormal sensations (ex. numbness)

• Cancer/tumors

• Epilepsy

• Cardiopathy (heart disease)

• Photo allergy or disorder (ex. Lupus, porphyria)

• Medications that cause light sensitivity

• Medications for severe acne

• Extreme sensitivity to light

• Melasma or hyperpigmentation (especially if exacerbated by

mild warmth)

• Suspicious lesions or skin cancer–please visit your physician

• If taking or using any retinol or sun-sensitive medications or

products or benzoyl peroxide do not use infrared light

Percussive Therapy Attachments

(Flat, Cone, Micro-point)

These recommendations are derived from consultation with

medical experts and the published research in regards to

precautions and contraindications as of the date of printing.

For up-to-date information, please visit us online.

Precautions

Due care is required in these circumstances and the use of the

devices may need to be modified (such as attachment used,

the force applied, the position of the body, avoidance of use in

direct contact with an area, etc.). Where appropriate or if you

have any concerns, seek the advice of a medical professional

• Recent injury, surgery, or facial treatment such as neurotoxin,

dermal filler, microneedling, laser, and/or chemical peel until

skin has fully healed.

• Current breakout from Herpes Simplex Virus

• Hypertension (controlled)

• Abnormal sensations (e.g., numbness)

• Sensitivity to pressure

• Medications that may alter sensations

• Do not apply directly to the eyeball/eyelid

• Do not apply to broken skin

Contraindications

The following are circumstances where the potential risks may

outweigh the benefits. Consult a medical professional before use.

• Skin rash, open wounds, blisters, local tissue inflammation,

infections, bruises, or tumors

• Active acne breakout

• Bone fracture or myositis ossificans

• Hypertension (uncontrolled)

• Acute or severe cardiac, liver, or kidney disease

• Neurologic conditions resulting in loss or altered sensation

• Direct application to the eyes or throat

• Bleeding disorders

• Recent surgery or injury

• Connective tissue disorders

• Peripheral vascular insufficiency or disease

• Medications that thin the blood or alter sensations

• Direct pressure over surgical site or hardware

• Extreme discomfort or pain

• Pacemaker, ICD, or history of embolism

Cleansing Ring Attachment

These recommendations are derived from consultation with

medical experts and the published research in regards to

precautions and contraindications as of the date of printing.

For up-to-date information, please visit us online.

Precautions

• Recent injury, surgery, or facial treatment such as neurotoxin,

dermal filler, microneedling, laser, and/or chemical peel until skin

has fully healed.

• Current breakout from Herpes Simplex Virus

• If you have facial hair, use the cleansing ring following the pattern

of hair growth (typically a downward motion) and/or make small

circular motions if comfortable

• Do not apply directly to the eyeball/eyelid

• Do not apply to broken skin

Contraindications

The following are circumstances where the potential risks may

outweigh the benefits. Consult a medical professional before use.

• Skin rash, open wounds, blisters, local tissue inflammation,

infections, bruises, or tumors

Hot Ring Attachment

These recommendations are derived from consultation with

medical experts and the published research in regards to

precautions and contraindications as of the date of printing. For

up-to-date information, please visit us online.

Precautions

• Recent injury, surgery, or facial treatment such as neurotoxin,

EN dermal filler, microneedling, laser, and/or chemical peel until

skin has fully healed.

• Current breakout from Herpes Simplex Virus

• Do not apply directly on the eyeball/eyelid

• Do not apply to broken skin

Contraindications

The following are circumstances where the potential risks may

outweigh the benefits. Consult a medical professional before use.

• Skin rash, open wounds, bliszters, local tissue

inflammation, infections, bruises, or tumors

Cold Ring Attachment

These recommendations are derived from consultation with

medical experts and the published research in regards to

precautions and contraindications.

Precautions

• Recent injury, surgery, or facial treatment such as neurotoxin,

dermal filler, microneedling, laser, and/or chemical peel until

skin has fully healed.

• Current breakout from Herpes Simplex Virus

• For facial hair use Cold Ring as noted in standard protocol

• Do not apply on the eyeball/eyelid

• Do not apply to broken skin

Contraindications

The following are circumstances where the potential risks may

outweigh the benefits. Consult a medical professional before use.

• Skin rash, open wounds, blisters, local tissue inflammation,

infections, bruises, or tumors

• Cold hypersensitivity/Cold urticaria

• Circulatory insufficiency

Additional Unit Warnings

When using the device, these basic precautions should

always be followed:

1. USE ONLY AS INSTRUCTED. Use the device as described

in the device User Manual only. Only use the recommended

attachments, accessories, and replacement parts. Do not carry

out any maintenance on your own.

2. NOT FOR CHILDREN. The device is not intended for use by

young children or persons with reduced physical, sensory, or

reasoning capabilities, or lack of experience and knowledge

with how the device should be operated, unless they have

been given supervision or instruction by a responsible person.

Do not allow the device to be used as a toy. Children should be

supervised to ensure that they do not play with the device.

3. CHARGING LOCATIONS. The device should be charged

indoors in a well ventilated, dry location. Do not charge the

device outdoors, in a bathroom, or within 10 feet (3.1 meters)

of a bathtub or pool. Do not use the device or charger on wet

surfaces and do not expose the charger to moisture, rain, or snow.

Do not use the device in the presence of explosive atmospheres

(gaseous fumes, dust, or flammable materials). Sparks may be

generated, possibly causing a fire.

4. DO NOT OVERCHARGE. Do not leave the battery in the

Charger for more than 1 hour after the battery has been fully

charged. The battery includes a Theragun Protection system

to avoid the risk of overcharging. However, overcharging may

reduce its life over time

5. DO NOT BURN OR INCINERATE THE DEVICE OR ITS

BATTERIES. The battery may explode, causing personal injury

or damage. Toxic fumes and materials are created when the

battery is burned.

6. DO NOT CRUSH, DROP, OR DAMAGE THE DEVICE

BATTERIES OR CHARGER. Do not use a charger that has

received a sharp blow, been dropped, run over, or damaged in

any way.

7. BATTERY CHEMICALS CAUSE SERIOUS BURNS. Never allow

the internal battery to come into contact with the skin, eyes, or

mouth. If a damaged battery leaks chemicals, use rubber or

neoprene gloves to dispose of it. If skin is exposed to battery

fluids, wash with soap and water and rinse with vinegar. If eyes

are exposed to battery chemicals, immediately flush with

water for 20 minutes and seek medical attention. Remove and

dispose of contaminated clothing.

8. DO NOT SHORT CIRCUIT. A battery will short circuit if a metal

object makes a connection between the positive and negative

contacts on the battery or the 16V connector. Do not place a

battery near anything that may cause a short circuit, such as

coins, keys, or nails in your pocket. A short circuited battery

may cause fire and personal injury.

9. DO NOT OPERATE UNDER BLANKET AND PILLOW OR

BETWEEN COUCH CUSHIONS. Excessive heating can occur

and cause fire, electric shock, or injury.

10. STORING THE DEVICE & BAT TERY. Store in a cool, dry place.

Only charge the device when the ambient temperature is

between 0°C/32°F - 40°C/104°F. Do not store the device or

batteries where temperatures may exceed 40°C/104°F, such as in

direct sunlight or in a vehicle.

11. DISPOSING OF BATTERIES. The TheraFace PRO lithium-ion

batteries for the device are more environmentally friendly

than some other types of batteries. Always dispose of device

batteries according to federal, state, and local regulations.

Contact a recycling agency in your area for recycling locations.

Even discharged batteries contain some energy. Before

disposing, use electrical tape to cover the device’s 16V

connector/terminals to prevent the battery from shorting,

which could cause a fire or explosion.

12. DO NOT DISASSEMBLE. Disassembly or incorrect reassembly

may result in the risk of electric shock, fire, or exposure to

battery chemicals. The warranty will be void if the device,

batteries, or charger are disassembled or if any parts have

been removed.

13. SERVICE. If the device, batteries, or charger is not working

properly, has received a sharp blow, or has been dropped,

damaged, left outdoors, or dropped into water, then do not use

it. Do not attempt to repair or disassemble the device which

may result in an electric shock or fire.

14. DO NOT USE WHILE BATHING OR IN THE SHOWER, TUB,

OR SINK. Do not place or store the device or batteries where

it can fall or be pulled into a tub or sink. Do not place in or

drop into water or other liquid. Do not reach for an appliance

that has fallen into or come into contact with water. Unplug

immediately.

15. THERMAL LIMITER. The device has an automatic reset thermal

limiter that shuts off the device to prevent overheating and fire.

16. POLARIZED PLUG. To reduce the risk of electric shock, this

appliance has a polarized plug (one blade is wider than the other).

This plug will fit in a polarized outlet only one way. If the plug

does not fit fully in the outlet, reverse the plug. If it still does not

fit, contact a qualified electrician to install the Theragun Proper

outlet. Do not change the plug in any way.

17. DO NOT OPERATE the device where aerosol (spray) is being

used or where oxygen is being administered.

SAVE THESE INSTRUCTIONS

Risk

1. Use the TheraFace PRO device and attachment rings only as

described within this User Manual. The risks and dangers of using

the TheraFace PRO device and attachment rings in any way other

than specified in the provided User Manual are unknown and may

result in negative side effects.

2. This TheraFace PRO device was not tested for use over the eye

socket or eyelid so the risks are unknown.

EN Labels

NO. SYMBOLS DESCRIPTION

1CE mark

2the Restriction of Hazardous Substances

3“WEEE (Waste Electrical and Electronic Equipment)”.

The waste products should be handled legally.

4Keep dry

5FCC Federal Communications Commission

6Please read the user manual before use

7Type BF apply part.

Product Specifications

BASIC UNIT CHARACTERISTICS

Power Source User supplied USB-A or USB-C adapter

Indicator Light YES

Housing Materials PC

ADDITIONAL FEATURES

Environment for operation Temperature: 0 ~ 40° C

Relative humidity: <93% RH

Environment for storage Temperature: -25° C ~ 50° C

Relative humidity: 10~95% RH

Use atmospheric pressure 70-106Kpa

Indicator Light Yes , OLED display

Timer Range 5-8 minutes per day for 6 weeks

Housing Materials Console: PC plastic

OUTPUT SPECIFICATION

Waveform Pulsed Biphasic

Operating voltage 0-15.5V

Maximum power 24mW

Automatic shut-down Yes

Maximum Output

Voltage(+/- 10%)

210-280mV @500 Ohm

0.8- 1.2V @ 2k Ohm

4.75-5.2V @ 10k Ohm

For Microcurrent Treatment:

Stimulated site Face and neck

Number of modes 3

Output Intensity Level 4

Maximum Output Current 420 μA - 560 μA @ 500 Ohm

400 μA - 600 μA @ 2k Ohm

475 μA - 520 μA @ 10k Ohm

Pulse Width On 60ms / O 60ms

Frequency 8.3Hz

Net Charge N/A - Battery operated

Maximum Current Density 1.65mA/cm^2 @ 500 Ohm

Maximum Power Density 1.36125mW/cm² @ 500Ω

FOR LED TREATMENT

Light wavelength IR+Red:830nm±10nm/633 ± 10 nm

Blue light:415nm±10nm, Red light:633nm±10nm

Power of light

(mW//cm2) IR+Red 70±5%/60±5%

Red light 60±5%, Blue light 45±5%

FOR PERCUSSIVE THERAPY

Percussive 1750, 2100 and 2400 rpm

Frequency 1750rpm :29.1Hz 2100rpm:35Hz 2400rpm:40Hz

1. This device is Class II equipment with type BF applied part. It complies with Medical

Electrical Safety Standards (IEC 60601-1).

2. This device is also compliant with Medical EMC Standard (IEC 60601-1-2).

3. All the user directly contracting materials for the main device housing and output

contacts in this device are biocompatible for its intended use. They comply with

biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation

and Sensitization).

Safety, EMC & Bio-compatibility

CAUTION:

Do not apply the device near any devices with Electromagnetic Interference (EMI),

such as cell phones, Magnetic Resonance Imaging (MRI), computerized axial

tomography (CT), diathermy, Radio Frequency Identification (RFID), etc. or MR

environment. EMI, RF devices or MR environment may affect the normal function of

the device or would cause user injury.

The TheraFace PRO has been tested and found to comply with the electromagnetic

compatibility (EMC) limits for medical device to IEC 60601-1-2: 2007. These limits

are designed to provide reasonable protection against harmful interference in a

typical medical installation.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two

conditions: (1) this device may not cause harmful interference, and (2) this device must accept

any interference received, including interference that may cause undesired operation. Changes

or modifications not expressly approved by the party responsible for compliance could void the

user’s authority to operate the equipment.

This equipment has been tested and found to comply with the limits for a Class B digital device,

pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection

against harmful interference in a residential installation. This equipment generates, uses and can

radiate radio frequency energy and, if not installed and used in accordance with the instructions,

may cause harmful interference to radio communications. However, there is no guarantee that

interference will not occur in a particular installation.

If this equipment does cause harmful interference to radio or television reception, which can be

determined by turning the equipment off and on, the user is encouraged to try to correct the

interference by one or more of the following measures:

FCC compliance statement

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and receiver.

• Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected.

• Consult the dealer or an experienced radio/TV technician for help.

MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The TheraFace PRO is intended for use in the electromagnetic environments specified below. The customer or the user of the TheraFace PRO should ensure that it is used in such an environment.

EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

RF emissions

CISPR 11 Group 1 The TheraFace PRO uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to

cause any interference in nearby electronic equipment.

RF emissions

CISPR 11 Class B The TheraFace PRO is suitable for use in all establishments, including domestic establishments and those directly connected to

the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2 Class A

Voltage function / flicker emissions

IEC 61000-3-2 Complies

The TheraFace PRO is intended for use in the electromagnetic environment specified below. The customer or the user of the TheraFace PRO should ensure that it is used in such an environment.

IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

Electrostatic discharge (ESD)

IEC 61000-4-2 ±6kV contact

±8kV air ±6kV contact

±8kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the

relative humidity should be at least 30%.

Electrostatic transient / burst

IEC 61000-4-4 ±2kV for power supply lines

±1kV for input/output lines ±2kV for power supply lines

±1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5 ±1kV differential mode