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

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| 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

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| 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).

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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