Théa BLEPHASTEAM User manual

Instructions for use |
EYELID WARMING DEVICE, MOIST HEAT TECHNOLOGY

1
Version: 2.6 - Release date 02/23/2021
INSTRUCTIONS FOR USE
Please read these instructions before use
EYELID WARMING DEVICE, MOIST HEAT TECHNOLOGY

32
| TABLE OF CONTENTS
1. GENERAL INFORMATION ........................................................................................................................................................... 6
2. CLINICAL INFORMATION.........................................................................................................................................................6-7
2.1. INDICATIONS.................................................................................................................................................................... 6
2.2. CONTRAINDICATIONS....................................................................................................................................................... 6
2.3. POTENTIAL SIDE EFFECTS................................................................................................................................................ 6
2.4. RECOMMENDATIONS FOR USE......................................................................................................................................... 6
2.5. BIBLIOGRAPHY................................................................................................................................................................. 7
2.6. WARNINGS AND PRECAUTIONS ........................................................................................................................................ 7
3. OPERATING INSTRUCTIONS..................................................................................................................................................7-10
3.1. HOW TO USE YOUR BLEPHASTEAM®..............................................................................................................................7-9
3.2. AFTER USING YOUR BLEPHASTEAM®.............................................................................................................................. 10
3.3. LONG TERM STORAGE OF YOUR BLEPHASTEAM®(longer than 2months) ....................................................................... 10
4. DEVICE DESCRIPTION AND EXAM ENVIRONMENT...............................................................................................................10-11
4.1. DEVICE DESCRIPTION................................................................................................................................................ 10-11
4.2. WEIGHT AND SIZE OF THE MAIN ELEMENTS ................................................................................................................... 11
4.3. USERS............................................................................................................................................................................ 11
5. SAFETY..............................................................................................................................................................................12-19
5.1. SYMBOLS..................................................................................................................................................................12-14
5.1.1. Symbols used in this manual................................................................................................................................ 12
5.1.2. Symbols on this device ...................................................................................................................................12-14
5.1.3. Disclaimer............................................................................................................................................................ 14
5.2. WARNINGS & CAUTIONS............................................................................................................................................14-15
5.3. ELECTRICAL SAFETY ...................................................................................................................................................... 15
5.4. COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS.......................................................................... 15
5.5. BLEPHASTEAM®DESCRIPTION ....................................................................................................................................... 16
5.6. LABELLING & POSITION.............................................................................................................................................17-18
5.6.1. Base station......................................................................................................................................................... 17
5.6.2. Interior side of BLEPHASTEAM®............................................................................................................................ 17
5.6.3. Batteries location (under cover)............................................................................................................................ 17
5.6.4. Water carrier........................................................................................................................................................ 17
5.6.5. Water tray............................................................................................................................................................ 17
5.6.6. Screwdriver ......................................................................................................................................................... 18
5.6.7. Power supply ....................................................................................................................................................... 18
5.7. AMBIENT CONDITIONS ................................................................................................................................................... 18
5.8. TRANSPORT AND PACKAGING......................................................................................................................................... 18
5.9. DISPOSAL AT THE END OF LIFE....................................................................................................................................... 18
5.10.PACKAGE CONTENTS.................................................................................................................................................18-19
6. EQUIPMENT ASSEMBLY / INSTALLATION ............................................................................................................................19-20
6.1. INSTALLATION................................................................................................................................................................ 19
6.2. INSERTING BATTERIES IN THE MAIN UNIT.................................................................................................................. 19-20
Warnings and Precautions for batteries.............................................................................................................19-20
6.3. PATIENT’S ENVIRONMENT .............................................................................................................................................. 20
7. MAINTENANCE AND INSPECTION ....................................................................................................................................... 20-22
7.1. DAILY INSPECTION.......................................................................................................................................................... 20
7.2. REPLACING BATTERIES................................................................................................................................................... 21
7.3. CLEANING YOUR BLEPHASTEAM®.............................................................................................................................. 21-22
7.3.1. Cleaning the base station (PN:T2422BS) ............................................................................................................. 21
7.3.2. Cleaning the mask (PN:T2422M) ......................................................................................................................... 21
7.3.3. Cleaning the water carrier or face seal (PN:T2422FSA or FSC) ............................................................................ 22
7.3.4. Cleaning the water tray (PN:T2422WT)................................................................................................................ 22
7.3.5. Maintain water dust and light resistance.............................................................................................................. 22
TROUBLESHOOTING...........................................................................................................................................................22-23
8. TECHNICAL SPECIFICATIONS & PERFORMANCE ...................................................................................................................... 23
8.1. ELECTRICAL RATINGS..................................................................................................................................................... 23
8.2. MATERIALS .................................................................................................................................................................... 23
9. ELECTROMAGNETIC COMPATIBILITY ..................................................................................................................................24-27
9.1. GENERAL PRECAUTIONS AND WARNINGS....................................................................................................................... 24
9.2. ELECTROMAGNETIC EMISSIONS..................................................................................................................................... 24
9.3. INTERFERENCE IMMUNITY.........................................................................................................................................25-26
9.4. IMMUNITY.................................................................................................................................................................26-27
10. CONTACT................................................................................................................................................................................ 28

54
| TABLE OF TABLES
TABLE1: WEIGHT AND SIZE OF THE MAIN ELEMENTS.................................................................................................................. 11
TABLE2: SYMBOLS USED IN THIS MANUAL................................................................................................................................. 12
TABLE3: SYMBOLS ON THIS DEVICE......................................................................................................................................12-14
TABLE4: COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATION.......................................................................... 15
TABLE5: DAILY INSPECTION TABLE ............................................................................................................................................. 20
TABLE6: TROUBLESHOOTING ................................................................................................................................................22-23
TABLE7: ELECTROMAGNETIC EMISSIONS ................................................................................................................................... 24
TABLE8: ELECTROMAGNETIC IMMUNITY..................................................................................................................................... 25
TABLE9: RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE & RF............................................................................. 26
TABLE10: GUIDANCE ON MANUFACTURER DECLARATION - ELECTROMAGNETIC IMMUNITY..................................................... 26-27
| TABLE OF FIGURES
FIGURE1: BLEPHASTEAM®FRONT SIDE AND REAR SIDE............................................................................................................... 11
FIGURE2: FRONT VIEW................................................................................................................................................................. 16
FIGURE3: REAR VIEW ................................................................................................................................................................... 16
FIGURE4: TOP VIEW ..................................................................................................................................................................... 16
FIGURE5: RIGHT & LEFT SIDES..................................................................................................................................................... 16
FIGURE6: BOTTOM VIEW.............................................................................................................................................................. 17
| FEATURES
BLEPHASTEAM®is a patented medical device based on the results of scientific research by Dr JR FULLER. This innovative device relieves
symptoms of Meibomian Glands Dysfunction and associated diseases. It reproduces an environment that naturally enhances tear film
quality and stability by reinforcing the thickness of the tear film lipid layer.
This layer prevents tear film evaporation; it is produced by Meibomian glands which are found in the eyelids. These glands can easily be
blocked, causing conditions such as dry eye syndrome, chalazion, blepharitis or ocular rosacea.
BLEPHASTEAM®spreads latent heat therapy which allows the melting of secretions and unblocks the Meibomian glands, improving tear
film stability.
BLEPHASTEAM®has been tested and validated to ensure safe use.
While using BLEPHASTEAM®, Meibomian glands are unblocked, tear quality is improved enhancing ocular surface health and comfort,
leading to clear vision.
| INTENTED USE
BLEPHASTEAM®is designed for relieving the symptoms caused by abnormal functioning of Meibomian glands and associated
diseases such as dry eye syndrome, chalazion, blepharitis or ocular rosacea.
Eyelid hygiene with warming followed by moderate to firm massage is recommended according to the report from the International
Workshop on MGD in case of Meibomian Gland Dysfunction.
The heat and moisture provided by the device melt the secretions that block these glands, making it easier to remove the secretions using
massage and pressure of the eyelids.
BLEPHASTEAM®improves tear film stability by reinforcing the lipid layer thickness and helps to decrease symptoms such as grittiness/
dryness, foreign body sensation or ocular discomfort.
The product is designed for indoor use only. This includes homecare use and/or use in healthcare practices (e.g. ophthalmologists,
optometrists…)
For any questions about this device or for medical advice, please contact your eye specialist or Laboratoires THEA (see contact details at
the end of this leaflet).

76
1. GENERAL INFORMATION
Laboratoires THÉA
12, rue Louis Blériot DISTRIBUTOR:
63017 Clermont-Ferrand See list at the end of leaflet
CEDEX 2 - FRANCE
Always keep this user manual and accompanied documents in a safe place close to the device. The user manual should be accessible to
the user at all times and the user should read all instructions carefully before using the device.
If you have technical problems with our product, please contact the BLEPHASTEAM®service Line. We require the following information in
order to provide you with the necessary assistance:
• Serial number of your BLEPHASTEAM®unit
France Laboratoires THEA
Clermont-Ferrand
2. CLINICAL INFORMATION
2.1. INDICATIONS
BLEPHASTEAM®is designed for relieving the symptoms caused by abnormal functioning of Meibomian glands and associated
diseases such as dry eye syndrome, chalazion, blepharitis or ocular rosacea.
Eyelid hygiene with warming followed by moderate to firm massage is recommended by International Guidelines in case of Meibomian
Gland Dysfunction (MGD).
The heat and moisture provided by the device melt the secretions that block these glands, making it easier to remove the secretions using
massage and pressure of the eyelids.
It has been reported that meibum melts at temperatures between 32°C (in normal subjects) and 45°C. Secretions from more severely
obstructed glands have been found to have considerably higher melting points than the secretions from apparently normal, unobstructed
glands, and thus to require higher temperatures maintained for longer periods of time for effective therapy. A constant warming of the
meibomian glands to 38°C is vital in MGD patients to liquefy the meibum oil before eyelid massage, whilst higher temperatures, preferably
40°C, are recommended for more severely obstructed glands.
Because the meibomian glands are located on the inner eyelid, it is important to ensure that the inner eyelid achieves a therapeutic
temperature and maintains that temperature long enough to melt the meibum. BLEPHASTEAM®provides safely a controlled moist heat
(thus also generating high levels of humidity that prevents or reduces evaporation from the aqueous layer of the tear film), delivering a
temperature of 42.5°C at the ocular surface. The heat released by BLEPHASTEAM®melts the meibum that blocks these glands and thus
facilitates its clearance though the application of pressure on the eyelids or massage. As shown in a number of clinical studies assessing
this device (in patients with MGD and/or dry eye related to MGD), this results in improving gland function, tear film thickness and stability
and, ultimately, ocular comfort (i.e., relief of ocular symptoms experienced by patients suffering from MGD).
BLEPHASTEAM®improves tear film stability by reinforcing the lipid layer thickness and helps to decrease symptoms such as grittiness/
dryness, foreign body sensation or ocular discomfort.
For any questions about this device or for medical advice, please contact your eye specialist or Laboratoires THEA (see contact details at
the beginning of this leaflet).
2.2. CONTRAINDICATIONS
Unless otherwise specified by your doctor, BLEPHASTEAM®must not be used in the following cases:
• Acute diseases of the eyes and/or eyelids
• Recent injury and corneal lesions or damage to the eye
• Meibomian seborrhoea (excessive secretion of sebum produced by the Meibomian glands)
• After surgery to or around the eye
• If you are allergic to any component (plastic compounds)
2.3. POTENTIAL SIDE EFFECTS
The possible following side effects have been reported:
• Irritation and redness around the eyes
• Eye pain
If you note any side effects or unusual sensation after using this device, please contact a health care professional or report
the information to the local distributor, to the manufacturer or to your local health authority (see contact at the end of this
instructions for use)
2.4. RECOMMENDATIONS FOR USE
It is recommended that you use BLEPHASTEAM®twice a day, unless your eye specialist tells you otherwise.Allow at least four hours before
each treatment session.
It is important that the instructions for use and the recommendations given by your eye specialist are followed.
Your BLEPHASTEAM®device is designed to be used by one person only for homecare use or by multiple users in healthcare practices and
must be cleaned after each use (See section7.3 cleaning your BLEPHASTEAM®).
2.5. BIBLIOGRAPHY
1.Driver PJ, Lemp MA. Meibomian gland dysfunction. Surv Ophthalmol 1996; 40(5): 343-67.
2.Foulks GN, Bron AJ. Meibomian gland dysfunction: a clinical scheme for description, diagnosis, classification, and grading. Ocul Surf
2003; 1(3):107-26.
3.Ong BL. Relation between contact lens wear and Meibomian gland dysfunction. Optom Vis Sci1996; 73(3):208-10.
4.Arita R, Itoh K, Inoue K, Kuchiba A, Yamaguchi T, Amano S. Contact Lens Wear Is Associated with Decrease of Meibomian glands.
Ophthalmology 2009; 116(3):379-84. Epub2009 Jan22.
5.Martin NF, Rubinfeld RS, Malley JD, Manzitti V. Giant papillary conjunctivitis and meibomian gland dysfunction blepharitis. CLAO J1992;
18:165-9.
6.McCulley JP, Sciallis GF. Meibomian keratoconjunctivitis. Am J Ophthalmol1997;84:788-93.
7.Guillon M, Styles E, Guillon JP, Maïssa C. Preocular tear film characteristics of nonwearers and soft contact lens wearers. Optom Vis Sci
1997; 74(5):273-9.
2.6 WARNINGS AND PRECAUTIONS
USAGE NOTES
The device must only be used for the intended use described in this manual.
Please read the entire instructions before using BLEPHASTEAM®.
WARNINGS
Use on clean eyes without any make-up or dermatologic ointment. Contact lenses and prescription glasses must be removed before the
treatment session.
BLEPHASTEAM®should not be used lying down.
It is best to be seated and not to move when using the device.
Blink normally while using the device.
This device should not be used by any patient (including children >3years old) who has low physical, sensory or mental abilities unless
supervised and on the advice of an eye care specialist.
This is a medical device that should only be used by a capable adult or, when used by children or certain adults, under the supervision of
a capable adult.
Keep the device out of the reach of children.
When used by children, BLEPHASTEAM®must be used in the presence of an adult.
CAUTION
Wash your hands before and after use.
BLEPHASTEAM®should be used by children only when supervised by an adult and after talking to an eye care specialist.
For users of contact lenses or glasses, always remove them before using BLEPHASTEAM®.
If you have a reaction to BLEPHASTEAM®, such as excessive sensitivity to heat or an allergic reaction to one of the components of the
device, stop the treatment immediately and talk to your doctor.
Eye drops should not be used for at least 15minutes before using BLEPHASTEAM®.
3. OPERATING INSTRUCTIONS
3.1 HOW TO USE YOUR BLEPHASTEAM
Note that all these stages are perfectly described and illustrated in the quick start manual.
Press the button to start the device.
It will pre-heat during 2-3mins until theBLEPHASTEAM®light will pulse
orange and give a short intermittent beep.
Remove the water
tray and water
carrier from base
station.
www.laboratoires-thea.com
+33473981436

98
Fill the water tray with bottled drinking water to the indicated water level.
Thoroughly wet the water carrier by holding the thumb tabs and
vigorously rocking the water carrier to and from in the tray for
5-10seconds.
BLEPHASTEAM®is ready to use when
3beeps and with green light pulsing.
If the BLEPHASTEAM®is left waiting for more than 10minutes, the device will switch off and all the steps of the
process will need to be restarted.
Once preheating is complete, remove the device from its
base station and insert the water carrier.
It can be done by placing the mask face down and sliding
the water carrier into the mask, holding the water
carrier by the two tabs on the sides.
In healthcare practices, patients should wear a hair hygiene
protection cap before using the mask.
Wear the mask and fit over your eyes.
The strap tension is adjustable.
Treatment is now in progress and will last 10minutes.
Two beeps will sound to indicate that the treatment is
finished, and the light will turn orange.
CAUTION Do not use while lying down.
WARNINGS
Do not touch the mask with your hands during the treatment.
BLEPHASTEAM®is vulnerable to damage caused by ESD (Electro Static Discharge), so avoid contact between the device and your
clothing.
Treatment takes 10minutes. At the end of treatment 2beeps will sound (repeating) and the orange status light will be on.
Massage your eyelids, and then clean them with a compress such as BLEPHACLEAN®.
BLEPHACLEAN®wipes can be ordered from Laboratoires THÉA or from www.BLEPHASTEAM®.com
Put the mask on its base after use. The green battery light will
flash while charging
CAUTION
Always charge the device after use.
When the batteries are charged, the green light will turn OFF.
The blue icon lights on the base and on the device remains on.
The device is now ready to start any time it may be needed.
It will take approximately 10minutes for the device to cool down.

1110
3.2 AFTER USING YOUR BLEPHASTEAM®
At home:
After use, water carrier and water tray should be cleaned, dried. All components should be stored at room temperature, in the original
packaging in order to protect from light and any source of heat
.
Water carrier (PN:T2422FSA for adult and T2422FSC for children) is reusable during maximum 3months. It is important to clean it
regularly after use
.
The recommended cleaning is with water and let it dry.
Wipe the mask (PN:T2422M) with provided cleaning cloth.
Put the mask on its base station (PN:T2422BS) to reload.
Base should be plugged in.
For healthcare practices use only
Water carrier is dedicated to one patient only.
It should be discarded after patient treatment and replaced between each patient.
Water carrier is not to be reused to avoid any cross contamination between patients.
The water carrier cannot be autoclaved.
For Mask (PN:T2422M) cleaning please refer to paragraph7.3 “cleaning”
Then put the mask on its base (PN:T2422BS) to reload.
Base should be plugged in.
Always charge the device after use.
Dry the water tray (PN:T2422WT) completely before storage.
3.3 LONG TERM STORAGE OF YOUR BLEPHASTEAM®(longer than 2months)
CAUTIONS
Always charge the device before storage (until the green light stops flashing).
Remove batteries when the batteries have run out, or when the instrument will not be used for extended periods (two months
or longer). Leaving the batteries inside the instrument for extended periods may cause leakage or batteries fluid. In addition,
when batteries have run out, remove all the batteries inside, and replace with new ones.
Failure to do so may result in dead batteries.
4. DEVICE DESCRIPTION AND EXAM ENVIRONMENT
4.1 DEVICE DESCRIPTION
The device is mainly composed of the following elements with Part Numbers (PN) mentioned (illustrated in Figure1):
• BLEPHASTEAM®(PN:T2422M)
• BLEPHASTEAM®base station (PN:T2422BS)
• Water carrier (PN:T2422FSA for adult and T2422FSC for children)
• Water tray (PN:T2422WT)
• Power supply (PN:T2422PS)
• Screwdriver (PN:T2422SD)
• Set of rechargeable batteries (PN:T2422BAT)
• Cleaning cloth (PN:T2422CC)
Start button
Power indicator
Status indicator
Charging indicator
Battery cover
Head strap
Water carrier
Rubber plug protecting the screw
Water tray
Base station power connection
Base station power indicator
Power supply
Cleaning cloth
BLEPHASTEAM®screwdriver
Figure1: BLEPHASTEAM®front side and rear side
4.2 WEIGHT AND SIZE OF THE MAIN ELEMENTS
Element Weight Size
Head unit 0.193kg 167x87mm
Face seal or water carrier 0.025kg 130x69mm
Water Tray 0.033kg 189x29mm
Base station 0.291kg 147x54mm
Total weight and size of the BLEPHASTEAM®0.542kg 189x102x141mm
Table1: Weight and size of the main elements
4.3 USERS
The device is intended for Homecare use (one person only) or for use in healthcare practices (multiple users).
Intended users are adults, children from 3years old (parents or carers should be present during the treatment), pregnant or breastfeeding
women based on the current knowledge.
Only visible
when illuminated

1312
5. SAFETY
5.1 SYMBOLS
5.1.1 Symbols used in this manual
Symbol Meaning Note
Warning Improper operation may result in serious injury*1
or death to the user or patient
Caution Improper operation may result in bodily injury*2
or property damage*3
Caution Disconnect the device from power supply
before servicing/cleaning
Note Important information for operation
Orange light Pre-heat step of the BLEPHASTEAM®(2-3mins) light will
pulse orange and give a short intermittent beep
Green Light ashing and 3beeps
sound BLEPHASTEAM®is ready for use
Table2: symbols used in IFU
*1 Serious injury means vision loss, high or low temperature burn, electrical shock, fracture, or poisoning that causes a subsequent
complication or requires hospitalization or long-term outpatient treatment.
*2 Bodily injury means an injury, burn, electrical shock and so forth that will not necessitate hospitalization or long-term outpatient
treatment.
*3 Damage to property means extensive damage to a house and/or household goods as well as a domestic animal and pet.
5.1.2 Symbols on this device
Symbol Standards Description
IEC60417-5840 Applied part Type BF
ISO7010-M002 Please refer to instruction manual
ISO15223-1 Manufacturer
ISO15223-1 Manufacturing date
ISO15223-1 Expiry date
Symbol Standards Description
Symbol5.3.4 (ISO7000-0626)
of ISO15223-1:2012 Moisture sensitive device
The device must be disposed of separately from domestic waste in accordance with WEEE provisions
for EU member countries, and with local recycling provisions and laws for all other countries.
ISO15223-1 Serial number
ISO15223-1 Product reference
Patient information web site
Medical Device
IEC60417-5172 ClassII device
(in compliance with EN60601-1standards)
IEC60417-5957 For indoor use only
IP21 IEC60529
Protection indice: Protects persons against access to
hazardous parts with fingers and against the harmful
effects due to water vertically dripping against the
enclosure
IP22 IEC60529
Protection indice: Protects persons against access to
hazardous parts with fingers and against the harmful
effects due to water dripped (15° tilted) against the
enclosure
ISO7010-W017 Warning; Hot surface

1514
Symbol Standards Description
IEC60417-5134 Electrostatic sensitive device
+40°C
-10°C
Symbol5.3.7(ISO7000-0632)
of ISO15223-1:2012
Temperature limits within which the device
can be safely exposed
Symbol5.3.8(ISO7000-2620)
of ISO15223-1:2012
Humidity limits within which the device
can be safely exposed
Symbol5.3.9(ISO7000-2621)
of ISO15223-1:2012
Pressure limits within with the device
can be safely exposed
“CE marking” Product compliant with EC Directive93/42/EEC
and subsequent amendments
Table3: Symbols on this device
5.1.3 Disclaimer
The warranty is valid eighteen months from the manufacturing date.The warranty covers any fault, material damage or manufacturing
defect in products used in accordance with the instructions in this leaflet.
This warranty does not preclude the application of current legal guarantees under national legislation governing the sale of consumer
goods.
Laboratoires THEA is not responsible for:
• Any damage resulting from disregarding what is described in this manual
• Any damage resulting from malfunctioning caused by a combination of connected devices
• Any damage resulting from transport, improper use or negligence, incorrect handling, modification of the system, poor
maintenance, use of wrong voltage, lightning, infiltration of sand or water, use of parts or accessories not provided or
recommended in this manual by Laboratoires THEA
5.2 WARNINGS & CAUTION
USAGE NOTES
BLEPHASTEAM®must only be used for the intended use described in this manual.
The device must be used in the specified ambient conditions.
WARNINGS
• Do not immerse the whole device in water or clean it in running water
• Do not use BLEPHASTEAM®near a mobile phone or radio emitter
• Do not touch the batteries location with a wet hand. Otherwise, it may cause electrical shock
• Do not short-circuit the batteries location. Otherwise it may cause fire or electrical shock
• Do not disassemble, modify or repair the instrument by yourself. Otherwise, it may cause fire, electrical shock, bodily injury, or
instrument malfunction. Refer all servicing to Laboratoires THEA or your authorized THEA dealer.The instrument disassembled,
modified or repaired by anyone other than a Laboratoires THEA designated repair facility will void the warranty
• Only use the specic rechargeable batteries provided by Laboratoires THEA. Use of batteries not specified by Laboratoires
THEA may cause fire or instrument malfunction
• If there is any abnormal odour, sound, heat, or smoke when power “ON” the device, turn the BLEPHASTEAM®switch
“OFF” immediately. Continued use may cause fire or instrument malfunction. Contact Laboratoires THEA or your authorized
Laboratoires THEA dealer for inspection
• BLEPHASTEAM®is vulnerable to damage caused by ESD (Electro Static Discharge), so avoid contact between the device and
your clothing
• Do not bend, crush or excessively strain the cable
• Do not attach or tighten cable to or around the head or neck. Cable can cause strangulation
• Do not expose the device to moisture. BLEPHASTEAM®is not water-proof and does not protect against the ingress of water or
moisture
• Do not place BLEPHASTEAM®in a microwave
• Do not autoclave BLEPHASTEAM®or its components
• Do not connect the device up to another appliance or to another source of power not provided by Laboratoires THEA. Otherwise,
it may lead to malfunctioning of the electromedical device or expose the user to higher electrical risks
• Do not operate the device in a hazardous environment that has a risk of explosion or contains volatile solvents (alcohol, etc.)
or flammable materials (anaesthetics, etc.) in the vicinity of the device
• Do not expose the device to very high temperatures or flames
• Do not use the device with a damage battery or charger (broken case, poor contact, broken feed cable). If the batteries are
damaged (cracked case, leakage of electrolyte, off-shape etc.) they should be replaced by the authorized personnel. Usage of
modified batteries may cause an explosion and/or damage the device
• Never attempt to access the internal hardware for any purpose including maintenance while the device is in operation. When
a function check is not successful, the user is prompted to contact technical service or the manufacturer
• Small Children: Do not leave your BLEPHASTEAM®and its accessories within the reach of small children or allow them to
play with it. They could hurt themselves or others or could accidentally damage the BLEPHASTEAM®. Your BLEPHASTEAM®
contains small parts with sharp edges that may cause an injury or may become detached and create a choking hazard
• Animals or insects: Do not leave your BLEPHASTEAM®and its accessories within the reach of animals or insects. After
treatment, your device must be put back in its original packaging
• The use of accessories other than those specied for the device is not recommended. They may result in increased
emissions or decreased immunity of the device
CAUTION
• This user manual must always be accessible and close to the device.The instructions manual should be accessible to the user
at all times and the user should consider all instructions carefully before using the device
• Only use the batteries supplied with the BLEPHASTEAM®. Use of batteries from other sources may cause damage, fire, injury
or instrument malfunction. For more information, see “Precautions for batteries” described in §6.
• Do not wipe the exterior of the mask with chemical products or solvent (e.g. acetone or ethanol). It may lead to dscolouration
or deterioration
• Do not allow terminal to come into contact with water as this may cause failure of the device. If BLEPHASTEAM®is dirty, wipe it
with a soft cloth containing no water
• Do not install the instrument on unstable location such as on a shaky base or a tilting surface. Otherwise, the instrument may
drop or fall over, causing a bodily injury
• If the device experienced an external mechanical impact (knocking, bumping, dropping, etc.), this type of shock may cause
malfunctioning of the device. In case of malfunctioning, please contact Laboratoires THEA or your authorized Laboratoires
THEA dealer for technical support
• Remove and store the batteries if the main unit will not be used for extended periods. Failure to do so may result in dead
batteries
• Insert the batteries in the battery compartment or the device may not work properly
• When using or carrying the instrument, hold it or attach it firmly. Dropping the instrument may lead to injury
• Periodic maintenance of BLEPHASTEAM®is not required by the user, only daily inspection is recommended. Maintenance of
the BLEPHASTEAM®is required when the device does not pass its function check. When the function check is not successful,
the user is prompted to contact technical support or the manufacturer (see last page)
5.3 ELECTRICAL SAFETY
BLEPHASTEAM®is supplied with a power plug cable. Do not use any other cable. Use the cable supplied with the device to connect the
device to the main power socket.
Position BLEPHASTEAM®so that the power cable is always accessible.
5.4 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS
Compliant standards Description Classication
IEC60601-1
• According to the type of protection against electric
shock
• According to the degree of protection against
electrical shock
• According to the mode of operation
ClassII (double isolation)
TypeBF
Continuous operation
IEC60601-1-2 • Electromagnetic compatibility * Refer EMC section10
IEC60529 • According to the type of protection against ingress
of water as detailed in the current edition of IEC
IP22 for the mask & IP21
for the base station
93/42EEC-2007 • According to the EU Medical Device Regulation Class IIa
Table4: Mains standards & Classification

Water tray
(PN:T2422WT)
Base station DC in
Water tray
Water carrier
(PN:T2422FSA or FSC)
Applied Part
Batteries cover
(PN:T2422BC)
USE SPECIFIED
BATTERIES ONLY
LABORATOIRES THEA
12 rue Louis Blériot 63017
Clermont-Ferrand Cedex 2
FRANCE
Tel: [phone]
T2422WT
LABORATOIRES THEA
T2422FSA
T2422FSC
Mask BLEPHASTEAM®
(PN:T2422M)
Head strap
(PN:T2422HS)
Applied Part
BLEPHASTEAM®base station
(PN:T2422BS)
1716
5.6 LABELLING & POSITION
5.6.1 Base station
Figure6: Bottom view
5.6.2 Interior side of BLEPHASTEAM®
WARNINGS
This symbol indicates that the surface temperature is high. DO NOT TOUCH.
5.6.3 Batteries location (under cover)
5.6.4 Water carrier
5.6.5 Water tray
5.5 BLEPHASTEAM®DESCRIPTION
Figure2: Front view
Figure3: Rear view
Figure4: Top view
Figure5: Right & Left sides

1918
5.6.6 Screw driver
5.6.7 Power supply
5.7 AMBIENT CONDITIONS
Transport Temperature -10°C to +40°C (14°Fto104°F)
Atmospheric pressure 500hPa to 1060hPa
Relative humidity 10% to 90%
Storage Temperature -10°C to +40°C (14°Fto104°F)
Atmospheric pressure 700hPa to 1060hPa
Relative humidity 10% to 90%
When your BLEPHASTEAM device has been stored@ -10°C:
• unpack and do not use for 1 hour until your device reaches ambient room temperature (around 20°C).
When your BLEPHASTEAM device has been stored@ 40°C:
• unpack and do not use for 40 minutes until your device reaches ambient room temperature (around 20°C).
Operating Temperature +15°C to +35°C (59°Fto95°F)
Atmospheric pressure 700hPa to 1060hPa
Relative humidity 30% to 70%
5.8 TRANSPORT AND PACKAGING
• The device must be transported and stored in original packaging. Storage and transport need to meet conditions described in
previous section5.7
• Keep original packaging in case of return or transport of device
• Check if there is any damage to the packaging box. If damage is found, there is a possibility of damage to the device as well.
Please notify the carrier if any damage is found and report to the manufacturer
• Leave the device in a room for 1hour before unpacking to ensure there is no condensation
• BLEPHASTEAM®is packed for shipping/transportation in a double cardboard box: the internal cardboard box with specially
shaped forms and cardboard parts support the main console without disassembling the device; the outer cardboard box with
vibration insulating layers on the top and bottom isolate the inner box from vibrations and minor mechanical impacts during
transport
Keep all original packaging for future use.The system must always be transported in its original packaging method specifically
designed to protect it against damage.
5.9 DISPOSAL AT THE END OF LIFE
According to Directives 2012/19/EU WEEE and 2011/65/EU RoHS II on the restriction of hazardous substances in electrical and electronic
equipment on their disposal.
Public authorities adopt adequate measures to make sure that users, distributors and manufacturers contribute to the collection of
electrical and electronic equipment, setting legal requirements for reusing, recovering or recycling said equipment.
The user must take into account the potentially harmful effects to the environment or human health due the improper disposal of
the equipment or of parts of it.
This graphic symbol shown in the figure is on the equipment’s label.
It reminds that all electrical and electronic equipment must be collected and disposed of separately at their end-of life.
5.10 PACKAGE CONTENTS
• Main unit: BLEPHASTEAM®(PN:T2422M)
• BLEPHASTEAM®base station (PN:T2422BS)
• Water carrier (PN:T2422FSA or FSC)
• Water tray (PN:T2422WT)
• AC adapter / Power supply (PN:T2422PS)
• Batteries (pack of 2batteries Li-FePO4) (PN:T2422BAT)
• User manual (PN:T2422UM)
• Screwdriver (PN:T2422SD)
• Protective housing/Softcase (PN:T2422SC)
• Cleaning cloth (PN:T2422CC)
6. EQUIPMENT ASSEMBLY / INSTALLATION
6.1 INSTALLATION
BLEPHASTEAM®is packed for shipping/transportation in a double cardboard box: The internal cardboard housing with specially shaped
forms and cardboards parts support the mask and accessories. The outer cardboard box with vibration insulating layers on the top and
bottom isolate the inner box from vibrations and minor impact during transport.
Keep all original packaging for future use.The system must always be transported in its original packaging method specifically
designed to protect it against damage.
6.2 INSERTING BATTERIES IN THE MAIN UNIT
Please note that for the first use, you need to install the specific rechargeable batteries provided only by THEA.
Remove the cover with the screw
driver provided.
Firmly insert batteries in the correct positions written on the cover.
The method of inserting batteries is to insert from the + terminal and push
on the - terminal.
Replace the batteries cover and screw it closed.
Then plug the base station with the correct power supply plug provided.
Put BLEPHASTEAM®on charge on the base station.
The BLEPHASTEAM®must be fully charged before the first use. Charging is complete when the green lights stop blinking.
The battery power allows the user to operate the BLEPHASTEAM® for a minimum of 10minutes (corresponding to the treatment time) .
The green Low Battery LED (See figure in5.1) on the BLEPHASTEAM®mask will illuminate continuously prior to the external batteries
running out of power.
The BLEPHASTEAM®battery pack is recharged by connecting it to an AC adaptor. Fully recharging the batteries takes approximately
1.5 hours. While charging, the LED indicator will be blue. When the batteries are fully charged, the LED will be green. If a fault is
encountered in the battery pack the orange LED device status indicator light flashes/stay on.
Then the base can stay plugged in permanently except if it is not used for a long time.
WARNINGS Precautions for batteries
Do not use any other batteries than the specific ones supplied. Damage from the use of these batteries may lead to fire, injury or instrument
malfunction.
• Use the following batteries is strictly recommended
Specific rechargeable Li-FePO4 Battery 3,2V-600mAh and provided by THEA
• When using rechargeable batteries, always use the charge recommended by LABORATOIRES THEA
Always take the following precautions to avoid a serious injury, burn or fire caused by heat build-up, ignition, explosion and fluid leakage
• If heat build-up occurs, immediately move away from the instrument. Leakage fluid or the instrument may catch fire and
explode
• If battery fluid gets into the eye, rinse it off with clean water and see doctor at once
• If your body or clothes are contaminated with battery fluid, wash it out

2120
USAGE NOTES
Remove batteries when the batteries have run out, or when the instrument will not be used for extended periods (twomonths
or longer). Leaving the batteries inside the instrument for extended periods may cause leakage or batteries fluid. In addition,
when batteries have run out, remove all the batteries inside, and replace with new ones.
6.3 USER’S ENVIRONMENT
When the patient may touch the devices (including the connecting devices) or when the patients may touch the person that comes into
contact with the devices (including the connecting devices), the patient’s environment is shown below.
In the user’s environment, use the device conforming to IEC60601-1. If you are compelled to use any device not conforming to IEC60601-1,
use an insulation transformer or the common protective earth system.
7. MAINTENANCE AND INSPECTION
Periodic maintenance of the instrument is not required by the user. Maintenance of the machine is required when the machine does not
pass its start-up process check (see section “Troubleshooting”). Then, the user is prompted to contact technical support.
Please read this section carefully in order to use BLEPHASTEAM®correctly and safely.
CAUTION
Remove and store the batteries if the main unit will not be used for extended periods. Failure to do so may result in dead batteries.
Never attempt to access the internal hardware for any purpose including maintenance while the device is in operation. When a function
check is not successful, the user is prompted to contact technical service or the manufacturer.
7.1 DAILY INSPECTION
• Inspect this instrument in accordance with table below:
BLEPHASTEAM®daily inspection table
Inspection item Procedure Acceptability criteria
Main unit BLEPHASTEAM®
(PN:T2422M) Visually verify that there is no problem
There is no deformation
When switch “ON”, pulse orange light is visible,
and a short intermittent beep is audible
Batteries location cover
(PN:T2422BC) Visually verify that there is no problem There is no deformation
There is no batteries leakage fluid
Water carrier
(PN:T2422FSA or FSC)
Visually check if the part is not soiled
or damaged
There are no contaminants and the part should be clean
There is no deformation
Water tray
(PN:T2422WT) Visually check if the part is not soiled There are no contaminants and the part should be clean
Head strap
(PN:T2422HS)
Visually verify that there is no problem
(deformation, etc…) The head strap should be adjustable
Base station
(PN:T2422BS) Visually verify that there is no problem
There is no deformation
When the base is connected, base power blue THEA logo
indicator is lighted
Table5: Daily inspection
7.2 REPLACING BATTERIES
When the orange and green device status light flash alternatively and the green batteries charging light is “ON” (continuously), power
supply voltage is falling.
Please replace with new batteries.
Remove the battery cover from BLEPHASTEAM®(specific screw driver is provided).
Remove batteries by pressing the (+) part.
Insert new batteries (see “inserting batteries in the main unit” for how to insert batteries).
When specic rechargeable batteries run out, place BLEPHASTEAM®on the base station and connect with the charger
recommended by Laboratoires THEA. Batteries are 100% charged after 2hours.
Dispose of batteries in accordance with the designated disposal method.
IMPORTANT
Homecare use:
• Keep in mind that the continuous lighting time will vary depending on a temperature or frequency of charging. In general,
the greater frequency of use shortens the continuous lighting time
• If the batteries should be left unused, the performance will gradually decrease even if it will not be used at all. If you have
extra batteries, please alternate them regularly to maintain efficient performance
7.3 CLEANING YOUR BLEPHASTEAM®
7.3.1 Cleaning the base station (PN:T2422BS)
WARNINGS
Switch off and disconnect the power supply before cleaning.
Do not share BLEPHASTEAM®with other people to prevent infection.
When the exterior of BLEPHASTEAM®is dirty, follow the steps below to clean it:
Turn “OFF” BLEPHASTEAM®.
Wipe the surface with a firmly squeezed, dampened soft cloth.
Wipe off the obstinate dirt with soft cloth, after dampening it in water.
CAUTIONS
• Do not wipe the exterior with chemical products or solvent (e.g. acetone or ethanol).It may lead to discolouration or deterioration
• Do not allow BLEPHASTEAM®to come into contact with water as this may cause failure of the device. If BLEPHASTEAM®
(interior) is dirty, wipe a soft cloth containing no water
• Please remember that BLEPHASTEAM®, batteries and charger are not waterproof. Do not use these devices in the bathroom
or areas with high temperature, humidity, dust or rain
• Mask can be cleaned up to 500 times.
7.3.2 Cleaning the mask (PN:T2422M)
IMPORTANT
Homecare use:
• Wiping the mask of BLEPHASTEAM®without removing dust or debris beforehand may scratch the surface
• Wiping the BLEPHASTEAM®mask with alcohol/solvent may lead to deterioration of the mask surface
WARNINGS
After cleaning the mask, make sure its integrity is correct (no spots or marks on the screen).
For healthcare practices use
Between two patients, used water carrier should be discarded, the mask should be cleaned with TRISTEL DUO®OPH only.
Please follow this cleaning protocol:
Dispense three pumps of TRISTEL DUO OPH onto a dry wipe (TRISTEL DUO Wipe is recommended). Use the wipe to spread
the foam over the surface of the mask and ensure all areas are covered except the metal parts (below the mask) and the
headstrap.
Leave the surface to dry and ensure a minimum contact time of 30seconds
Rinse the mask with TRISTEL DUO®Rinsing wipes
• Further details available and TRISTEL DUO®OPH Products can be ordered on www.tristel.com
Rules applicable for the user’s environment

2322
7.3.3 Cleaning the water carrier (PN: T2422FSA or FSC)
WARNINGS
Homecare use:
• Water carrier must be cleaned after each use with water
• Dry the water carrier completely before storage and reuse
IMPORTANT
• Water carriers have an estimated limited lifetime: 3months
For healthcare practices use only:
Water carriers cannot be used on different patients. After every single use, discard the water carrier. It should not be cleaned
or autoclaved.
Water Carrier (PN: T2422FSA for adult or PN: T2422FSC for children) could be ordered from Laboratoires THÉA or from
www.blephasteam.com.
7.3.4 Cleaning the water tray (PN:T2422WT)
• Water tray must be completely dried after use by draining it upside down
7.3.5 Maintain water dust and light resistance
The device is rated IP22 using the Ingress Protection rating system.
Your device has been tested in a controlled environment and shown to be water and dust resistant in certain circumstances (meets
requirements of classification IP22 as described by the international standard IEC60529 - Degrees of Protection provided by Enclosures
[IP Code]). Despite this classification, your device is not impervious to water damage in any situation. It is important that all compartments
are closed tightly.
Note: If any liquid is found to have entered your device components or an internally sealed system, this condition will void your device
warranty. Follow these tips carefully to prevent damage to the device.
• Any device which uses accessible compartments or ports that can be opened, should have these sealed or closed tightly to
prevent liquid from entering the system
• Whenever your device gets wet, dry it thoroughly with a clean, soft cloth. If your device has gotten wet, you should dry the
inside of the charging port before inserting a power connector to charge your device. If the charging port is not fully dry, your
device may operate abnormally. For example, it may charge more slowly or overheat
• If the device is exposed to any liquid, dry it thoroughly with a clean, soft cloth. Failure to dry it as instructed may cause the
device to suffer from operability or cosmetic issues
• Do not expose the device to sunlight. If the device is dropped or receives an impact, the water and dust resistant features of
the device may be damaged
TROUBLESHOOTING
When a problem occurs, check the items shown below first. Look for the problem from those shown in the following list and apply the
applicable remedy.If the described applicable remedy does not eliminate the problem or you encounter a problem that is not listed, contact
Laboratoires THEA or your authorized Laboratoires THEA dealer.
This section describes troubleshooting procedures to solve problem you may encounter.
Indication Cause Action
Blue THEA logo on the base
is not lighted There is no power to the device
Check if the mains power outlet is not faulty
and is switched ON
Check if the power cable on the back of the
BLEPHASTEAM®is fully in
Blue THEA logo on the headset
is not lighted
The headset is not correctly
seated on the base station
Lift up the headset and replace carefully
back on the base station
4audible alert beeps, followed by
the green batteries light flashing.
(Should this occur, it will normally be
during treatment)
Batteries are becoming tired
Order new batteries (PN:T2422BAT) from
stockist. Replace batteries when convenient.
(The device can still be used)
The device status light is flashing
orange and green and the green
batteries charging light is on
(Continuously)
The batteries are exhausted
Replace batteries with new batteries
(PN:T2422BAT).
(The device cannot be used)
Indication Cause Action
The device status light is flashing
orange and green
The device has detected
a temperature problem
Remove water carrier, unscrew battery
cover and remove batteries
Wait for 15minutes with device away from
any heat source or draft. Replace batteries,
cover and screw
Return device to the base station
and restart normally
If the problem persists, contact your
BLEPHASTEAM®Stockist/reseller
The orange and green device status
lights flash alternately and the THEA
blue light flashes
The device has an internal fault Contact your BLEPHASTEAM®
Stockist/reseller
Table6: Trouble shooting
8. TECHNICAL SPECIFICATIONS & PERFORMANCE
8.1 ELECTRICAL RATINGS
Power supply External module with automatic voltage adaptation: no selection is needed
Input voltage range 100-240V
Ingress protection IP21
Frequency range 50-60Hz
Inputs current 0.8A@100V
BLEPHASTEAM®consumption 12V1.5A
Class II(double isolation)
Reference BI22-120150-AdV
Trade Mark Biron
BLEPHASTEAM®lifetime 4Years
Plug adapter is the isolation element of the network
Batteries Li-FePO4 rechargeable 3,2V14500-600mAh*
Rated voltage/Rated capacity DC3.2V/600mAh
Trade Mark Batteries (by THEA/Ronda)
Operating Time with full Charge batteries 10 minutes +/- 1 minute
Batteries Life Time 1year life When used 2times a day
The spare batteries (PN:T2422BAT) and water carrier (PN:T2422FSA or FSC) must be ordered from
Laboratoires THÉA or from www.blephasteam.com.
* Batteries life and values mentioned above might vary depending on usage mode, connectivity and settings.
8.2 MATERIALS
Water carrier TPE (Soft plastic) / Polycarbonate (Hard plastic)

2524
9. ELECTROMAGNETIC COMPATIBILITY
9.1 GENERAL PRECAUTIONS AND WARNINGS
• Electrical medical devices and systems are subject to special measures concerning electromagnetic compatibility (EMC) and
must be installed in accordance with the EMC instructions contained in this enclosed document
• Portable and mobile radiofrequency communication systems may interfere with electrical medical devices
• Use of accessories and cables other than those supplied with the instruments, except the cable sold by the equipment
manufacturer as spare parts, may lead to an increase in emissions and reduce the device’s or system’s immunity
• The device must not be used in contact with other devices
• This instrument is not designated to be used to an external instrument or placed on top of another. Nevertheless, if such use
is inevitable, it is necessary to monitor constantly to ensure the instrument is functioning normally after such use has been
adopted
CAUTIONS
• If the device experienced an external mechanical impact on the mask (knocking, bumping, dropping, etc.), this type of shock
may cause malfunctioning of the device. In case of malfunctioning, please contact Laboratoires THEA or your authorized
Laboratoires THEA dealer for technical support
Essential Performance of the system (Signicant operating characteristics)
BLEPHASTEAM®monitors heat therapy (42.5±3°C) during a period of time (10±1min) in an enclosed environment.
9.2 ELECTROMAGNETIC EMISSIONS
The device is intended for use in the following electromagnetic environment. The user must ensure compliance with this guideline.
Guidance and manufacturer’s declaration - electromagnetic emissions
The BLEPHASTEAM®is intended for use in the electromagnetic environment specied below.
The operator of the BLEPHASTEAM®has to make sure that it is used in such an environment.
Emission test Compliance Electromagnetic environment -
Guidance
Radiated RF emission acc. to CISPR 11 Group1
ClassB
The BLEPHASTEAM®uses RF energy only
for its internal functions. Therefore, its RF
emissions are very low and are not likely
to impair nearby electronic equipment.
Conducted RF emissions acc. to CISPR11 Group1
ClassA
The BLEPHASTEAM®is not suitable in all
establishments other than those in living
areas and those directly connected to the
public low voltage power supply network
that also supplies buildings used for living.
Harmonic emissions acc. to IEC 61000-3-2 Compliant
Voltage uctuations /
Flicker emissions acc. to IEC 61000-3-3 Compliant
Table7: Electromagnetic emissions
9.3 INTERFERENCE IMMUNITY
The device is intended for use in the following electromagnetic environment. The user must ensure compliance with this guideline.
Guidance and manufacturer declaration - electromagnetic immunity
The BLEPHASTEAM®is intended for use in the electromagnetic environment specied below.
The operator of the BLEPHASTEAM®has to ensure that it is used in such an environment.
Immunity Test IEC 60601
test level Compliance level Electromagnetic environment - Guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the BLEPHASTEAM®,
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance.
Conducted RF
disturbances
according to
IEC 61000-4-6
3Veff
150kHz to
80MHz
Not applicable
Recommended separation distance.
This test is not applicable since the equipment has no power
or input/output line.
Radiated RF
disturbances
according to
IEC 61000-4-3
10V/m
80MHz to
2.5GHz
10V/m
d =1.2√P for 80MHz to 800MHz
d =2.3√P for 800MHz to 2.5GHz
Where
P is the maximum emission output power of the
transmitter in watts (W) according to the transmitter
manufacturer and
d is the recommended separation distance
in metres (m).
Field strength from fixed RF transmitters, as determined
by an electromagnetic site surveya, should be less than the
compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked
with the following symbol:
NOTE1: At 80MHz and 800MHz the separation distance for the higher frequency range applies.
NOTE2: This guidance may not apply in all situations. Electromagnetic propagation is affected by absorption and reection
from structures, objects and people.
aField strength from xed transmitters, such as base stations for radio (Cellular/cordless) 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 xed RF transmitters, an electromagnetic site survey should be considered. If the
measured eld strength in the location in which the device BLEPHASTEAM®is used exceeds the applicable RF compliance
level above, additional measures may be necessary, such as reorientation or relocating the BLEPHASTEAM®. In case
unusual performance is witnessed, additional measures may be required such as change of orientation or location of the
BLEPHASTEAM®.
bField strength should be less than 10V/m in the range between 150kHz and 80MHz.
Table8: Electromagnetic immunity
The BLEPHASTEAM®is intended for use in an electromagnetic environment where radiated RF disturbances are under control. The
customer or the user of the device can help prevent electromagnetic interference by maintain a minimum distance between mobile and
portable RF communication devices (transmitters) and the BLEPHASTEAM®device as recommended below, according to the maximum
output power of the radio communications devices.

2726
Recommended separation distances between portable and mobile RF communications equipment and the BLEPHASTEAM®
The BLEPHASTEAM®is intended for use in an electromagnetic environment in which the radiated RF disturbances are
controlled. The BLEPHASTEAM®user can help prevent electromagnetic interference by maintaining a minimal distance
between portable and mobile RF communications equipment (transmitters) and the BLEPHASTEAM®as recommended
below, according to the maximum output power of the communications equipment.
Maximum transmitter
power output(W)
Separation distance according to the transmitter’s frequency(m)
150kHz to 80MHz 80MHz to 800MHz 800MHz to 2,5GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in metres (m)
can be determined using the equation applicable to the frequency of the transmitter, where
P is the maximum emission
output power of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE1: Between 80MHz and 800MHz, separation distance for the highest frequency range applies.
NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reection from structures, objects and people.
Table9: Recommended separation distance between portable & Radio Frequency
Note: 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 this product is used exceeds the applicable RF compliance level above, this product should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating this product.
9.4 IMMUNITY
The device is intended for use in the following electromagnetic environment. The user must ensure compliance with this guideline.
Guidance and manufacturer declaration - electromagnetic immunity
The BLEPHASTEAM®is intended for use in the electromagnetic environment specied below.
The operator of the BLEPHASTEAM®has to ensure that it is used in such an environment.
Immunity test IEC60601
test level Compliance level Electromagnetic environment - Guidance
Electrostatic discharge
(ESD) acc. to IEC61000-4-2
- ±8kV contact
discharge
- ±15kV air
discharge
Limited to ±8kV contact
discharge test
Limited to ±8kV air
discharge test
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
materials, the relative humidity should
be at least 30%.
Electrical fast transients/
burst acc. to IEC61000-4-4
- ±2kV/100Hz for
power supply
lines
±2kV/100Hz for
power supply lines
The quality of the supply voltage should
correspond with one characteristic
for a typical commercial or hospital
environment.
Surge acc. to IEC61000-4-5
- ±0.5, ±1kV
differential
mode
±0.5, ±1kV
differential mode
The quality of the supply voltage should
correspond with one characteristic
for a typical commercial or hospital
environment.
Guidance and manufacturer declaration - electromagnetic immunity
The BLEPHASTEAM®is intended for use in the electromagnetic environment specied below.
The operator of the BLEPHASTEAM®has to ensure that it is used in such an environment.
Voltage dips, short-term
interruptions and voltage
variations on power supply
input lines acc.
to 61000-4-11
<5%
U Tfor 0.5periods
40%
U Tfor 5periods
70%
U Tfor 25periods
<5%
U Tfor 5s
Compliant to the
specified levels
Compliant
The quality of the supply voltage should
correspond to one characteristic for a typical
commercial or hospital environment. If the
user of the BLEPHASTEAM®requires a
continuous function of the appliance also
during interruptions of the power supply, it is
recommended to supply the BLEPHASTEAM®
out of an uninterruptible power supply or a
batteries.
Power frequency (50/60Hz)
magnetic fields acc.
to IEC61000-4-8
30A/m 30A/m
Power frequency magnetic fields should be
at levels characteristic for commercial or
hospital environments.
NOTE:
U Tis the voltage of the alternative supply voltage before the application of the test level
Table10: Guidance on manufacturer declaration - electromagnetic immunity
CAUTION
Note:
If spots or marks appear on the screen, that means potential defects occur and the mask and potential electrical interference is present
with the system. If present, discontinue the use of the device until you contact Laboratoires THEA or your authorized Laboratoires THEA
dealer for technical support.
In order to avoid Hight level of ESD discharge, it is recommended not to touch the mask with your hands during treatment.
Interference may occur in the vicinity of equipment marked with the following symbol:

28
www.Blephasteam.com
Laboratoires THÉA
12, rue Louis Blériot
63017 Clermont-Ferrand CEDEX 2 - FRANCE
10. CONTACT
If you have technical problems with our product, please contact the BLEPHASTEAM®service line. We require the following information in
order to provide you with the necessary assistance:
• Serial number of your BLEPHASTEAM®unit
France Laboratoires THEA
Clermont-Ferrand www.laboratoires-thea.com +33473981436
UK
Distributor
THEA Pharmaceuticals Ltd, MEDIC5,
Innovation Way, Keele University Science and
Innovation Park, Keele, Newcastle Under Lyme,
Staffordshire, ST55NT
www.thea-pharmaceuticals.co.uk
03455211290
Health authority
Medicines and Healthcare products Regulatory
Agency, 10South Colonnade, London, E144PU
www.gov.uk
02030806000
IE
Distributor THEA Pamex Ltd, 14Moneen Business Park,
Castlebar, Co. Mayo 0949250290
Health authority
Health Products Regulatory Authority,
Kevin O’Malley House, Earlsfort Centre,
Earlsfort Terrace, Dublin2, D02XP77
16764971
www.hpra.ie

N2422MCL01/1020