Frequently Asked Questions
INDICATIONS DEVICE | INSTRUCTION FOR USE | CLEANSING | TECHNICAL QUESTIONS
INDICATIONS-DEVICE
What is Blephasteam®?
Blephasteam® is an innovative patented Medical Device class IIa, based on the results of scientific research by Dr JR FULLER, a British Ophthalmologist, and his brother T. FULLER, a British Engineer.
This innovative device delivers monitored moist heat for a time-controlled session of 10 min around the eyelids which allows the melting of secretions and unblocks the Meibomian glands, thus improving eyelid health and ocular comfort.
This innovative device delivers monitored moist heat for a time-controlled session of 10 min around the eyelids which allows the melting of secretions and unblocks the Meibomian glands, thus improving eyelid health and ocular comfort.
What is Blephasteam® used for?
Blephasteam® is designed for relieving symptoms caused by Meibomiam Gland Dysfunction (MGD) 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 an international Workshop in case of Meibomian Gland Dysfunction (MGD)(4). Blephasteam® helps to decrease symptoms such as grittiness/dryness/foreign body sensation or ocular discomfort.
Eyelid hygiene with warming followed by moderate to firm massage is recommended by an international Workshop in case of Meibomian Gland Dysfunction (MGD)(4). Blephasteam® helps to decrease symptoms such as grittiness/dryness/foreign body sensation or ocular discomfort.
What is the medical status of Blephasteam®?
Blephasteam® is a Medical Device class IIa.
How does Blephasteam® work?
Blephasteam® safely and effectively warms the eyelids to restore the flow of oil (meibum) from the
meibomian glands.
The heat and moisture provided by Blephasteam® melt the secretions that block the meibomian glands in case of MGD, making it easier to remove the secretions using massage and pressure of the eyelids. Blephasteam® reproduces an environment that naturally enhances tear film quality and stability by reinforcing the thickness of the tear film lipid layer, that improves the eye surface health and daily comfort.
The heat and moisture provided by Blephasteam® melt the secretions that block the meibomian glands in case of MGD, making it easier to remove the secretions using massage and pressure of the eyelids. Blephasteam® reproduces an environment that naturally enhances tear film quality and stability by reinforcing the thickness of the tear film lipid layer, that improves the eye surface health and daily comfort.
What is the temperature reached with Blephasteam®?
The safety and efficacy of Blephasteam® have been evaluated in many clinical studies. Blephasteam® safely provides a controlled moist heat, delivering a temperature of approximatively 42.5°C.
It has been shown that a constant warming of the meibomian glands to ≥ 38°C is vital in MGD patients to liquify the meibomian secretions before eyelid massage(1), whilst higher temperatures, preferably ≥ 40°C are recommended for effective liquefaction of more severely obstructed glands(2,3).
After warming with Blephasteam®, are there any other steps to take for eyelid hygiene ?
In case of MGD, it is recommended to have a daily eyelid hygiene routine with 3 key steps (4)
1. Eyelid warming : with Blephasteam® to liquify the meibomian secretions thanks to the moist heat.
2. Eyelid massage : on each upper and lower eyelid for a few seconds, to expel the meibomian secretions already fluidified thanks to Blephasteam®.
3. Eyelid cleansing : of the edges of both upper and lower eyelids, to remove crust, bacteria and debris from eyelids with a cleansing product such as Blephaclean®
1. Eyelid warming : with Blephasteam® to liquify the meibomian secretions thanks to the moist heat.
2. Eyelid massage : on each upper and lower eyelid for a few seconds, to expel the meibomian secretions already fluidified thanks to Blephasteam®.
3. Eyelid cleansing : of the edges of both upper and lower eyelids, to remove crust, bacteria and debris from eyelids with a cleansing product such as Blephaclean®
What is the difference between the new Blephasteam® and the previous version ?
The Blephasteam® new generation device includes many improvements : wireless device, warmup of only 3 to 4 minutes (versus 15 minutes for the previous version), for adults and children from 3 years old, more comfortable for patients, a clear and wider vision during the treatment versus session while maintaining the performance and safety of the previous Blephasteam® version demonstrated in clinical studies(1).
Moreover, the faceseal can be used by one person only for home care use. The new Blephasteam® can be used by multiple users/patients in healthcare practices (in doctors’ offices or clinics) following a cleaning protocol.
Moreover, the faceseal can be used by one person only for home care use. The new Blephasteam® can be used by multiple users/patients in healthcare practices (in doctors’ offices or clinics) following a cleaning protocol.
What is the difference between Blephasteam® and Blepha Eyebag®?
Blephasteam® is for patients diagnosed with MGD or associated diseases such as dry eye syndrome, blepharitis, chalazion or ocular rosacea.
and also for patients who have often tried many other solutions before using Blephasteam® and for chronic patients.
Blepha Eyebag® is a 1st intention treatment for consumers with MGD, or blepharitis or dry eye, suffering from dry, tired & sore eyes, who want to make their eyes comfortable daily, trying heating for the first time to relieve their symptoms.
Type of heat : Blepha Eyebag® provides heat monitored from the linseed when microwaved, and Blephasteam® provides moist heat delivering a temperature of 42.5°C.
and also for patients who have often tried many other solutions before using Blephasteam® and for chronic patients.
Blepha Eyebag® is a 1st intention treatment for consumers with MGD, or blepharitis or dry eye, suffering from dry, tired & sore eyes, who want to make their eyes comfortable daily, trying heating for the first time to relieve their symptoms.
Type of heat : Blepha Eyebag® provides heat monitored from the linseed when microwaved, and Blephasteam® provides moist heat delivering a temperature of 42.5°C.
Are there any potential side effects that can occur with Blephasteam®?
The possible side effects that have been reported are irritation and redness around the eye and eye pain.
If you note any side effects or unusual sensations after using this product, please contact a healthcare professional and report the information to the local distributor or to the manufacturer (see contacts at the end of the instructions for use).
If you note any side effects or unusual sensations after using this product, please contact a healthcare professional and report the information to the local distributor or to the manufacturer (see contacts at the end of the instructions for use).
What is the lifetime of Blephasteam®?
Based on current data, Blephasteam® has a lifetime of 4 years, but it can last even longer if properly used.
How long does the Blephasteam® warranty last ?
There is a 24 months warranty from the purchase date.
Where can I buy Blephasteam® and Blephasteam® spare parts ?
Blephasteam® and Blephasteam® spare parts (batteries, adult water carrier, children water carrier)
can be ordered from Laboratoires Théa or from www.blephasteam.com or by direct contact with Théa representatives in your country.
How often should the spare parts be changed ?
For the water carrier :
• Home care use (used by one person only) : the water carrier should be changed every 3 months.
• Healthcare practice use (used by different patients in doctors' offices) : the water carrier is dedicated to one patient and must be changed between each patient(1 water carrier/patient).
After every single use, discard the water carrier. It should not be cleaned or autoclaved.
For the batteries:
• If Blephasteam® is used twice a day, the batteries should last about one year, but will last longer if used less frequently.
• If Blephasteam® is used more than twice a day (in doctors’ offices on several patients), the batteries may need to be replaced more often than once a year.
• Home care use (used by one person only) : the water carrier should be changed every 3 months.
• Healthcare practice use (used by different patients in doctors' offices) : the water carrier is dedicated to one patient and must be changed between each patient(1 water carrier/patient).
After every single use, discard the water carrier. It should not be cleaned or autoclaved.
For the batteries:
• If Blephasteam® is used twice a day, the batteries should last about one year, but will last longer if used less frequently.
• If Blephasteam® is used more than twice a day (in doctors’ offices on several patients), the batteries may need to be replaced more often than once a year.
How to return a faulty device or if technical problems are detected ?
If a patient has technical problems with Blephasteam® or a question related to the functioning of its system, he should contact Laboratoires Théa : www.Blephasteam.com to obtain with the necessary assistance.
INSTRUCTION FOR USE
How to use Blephasteam®? (How to use Page - Preparation Getting start)
It is recommended to use Blephasteam® twice a day, during 10 min for each use, unless otherwise
recommended by the eye specialist.
It is important that the instructions for use and the recommendations given by the eye specialist are followed..
Wait at least four hours between each treatment session.
Blephasteam® is designed to be used :
• By one person only for home care use.
• By multiple users/patients in healthcare practices (in doctors’ offices or clinics) following a
cleaning protocol between each user/patient.
Who can use Blephasteam®?
Blephasteam® can be used by adults(including pregnant and breastfeeding women) and children
from 3 years old (with the presence of a parent or carer).
In which cases should Blephasteam® not be used?
Unless otherwise specified by doctors, 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 the patient is allergic to any component (plastic compounds).
Can Blephasteam® be used on eyes with make-up ?
Blephasteam® should be used on clean eyes without any make-up or dermatologic ointment.
Can Blephasteam® be used after an eye drop instillation ?
Eye drops should not be used for at least 15 min before using Blephasteam®.
Is it possible to use Blephasteam® lying down ? (How to Use Page - Preparation/Treatment)
Blephasteam® shall not be used lying down, it is best to be seated and not to move when using the device to have a good moist heat transfer, device functioning and temperature monitoring.
Blink normally while using the device, and thanks to the clear and wider vision area, some activities are possible during the treatment session like reading, watching tv…
How long does a treatment session with Blephasteam® last ? (How to Use Page - Treatment)
The treatment session with Blephasteam® lasts 10 min, and before use the device should be pre-heated
during only 3 to 4 minutes if the batteries are fully charged.
How many times can Blephasteam® be used after having charged it ? (How to use Page - Storage)
Always charge the device after each treatment session. Before initial use, the charging time could reach 90 minutes, but in daily use when the mask has been replaced on its base station after using it, it will take 45-60 minutes.
After each use, replace the mask on its base, the green battery light flashes while the device is charging, and charging is complete when the green battery light stops blinking.
The base can stay plugged in if used daily or twice a week, but if not used as frequently, it is better to disconnect.
How do I insert the Blephasteam® batteries ? ( How to Use Page - Getting Started )
The first time, the patient must install the rechargeable batteries specifically supplied by Théa. Remove
the battery protection cover first using the screwdriver provided. Then insert the batteries according to the polarities indicated.
- To insert batteries, start by putting them in on the + side and press down on the - side. - Replace the battery cover, screw it on. - Then plug the base station into the power outlet and leave Blephasteam® to charge.
Do we need to use a specific plug adaptator for electric connection ? ( How to Use Page - Getting started )
Blephasteam® is sold in a ready-to-use package (for UK market, the device is already supplied with the adequate plug).
Do not use with other electrical formats than 220-240V / 50Hz.
How to store Blephasteam® ? ( How to Use - Storage )
• If Blephasteam® is used intermittently, it is recommended to leave the device plugged in to the base station.
• Blephasteam® can be stored in its carry case at any stage for convenience.
• If Blephasteam® is not intended to be used for a long period (more than 2 months), it is recommended to remove the batteries, as they could leak and damage the device.
Note: after an extended period of storage, the batteries will need up to 3 hours for recharging.
• Blephasteam® can be stored at temperatures between -10°C and +40°C.
What type of water should I use to wet the water carrier ? (How to Use Page - Preparation )
For the preparation of Blephasteam®, use bottled drinking water to fill the water tray and then wet the water carrier.
Is it possible to use other batteries than those supplied by Théa ?
Do not use any other batteries than the specific ones supplied with the device or by Théa. Use only the specific rechargeable batteries provided by Laboratoires Théa. Other batteries can cause damage that may lead to fire, injury, or instrument malfunction and void the warranty.
Can Blephasteam® be used by several people ?
For home care use, Blephasteam® should not be shared with other people, it is for personal use, to prevent infection.
For office and clinic use by doctors: Blephasteam® can be used on several patients but following a cleaning protocol between each patient (see cleansing section).
CLEANSING
How can I clean my Blephasteam® mask ? (How to Use - Storage )
-For home use: the water carrier and water tray should be cleaned with water and left until completely dry. Wipe the mask with the provided cleaning cloth and put the mask on its base station to charge.
-For healthcare professionals use (doctors’ offices and clinics) :
To avoid any cross contamination between patients, the water carrier should be discarded after patient
treatment and replaced between each patient (1 face seal/ patient).
The mask should be cleaned between each patient with Tristel® Duo OPH only following this protocol:
1. Dispense 3 pumps of the product onto a dry wipe and spread the foam over the surface of the mask and ensure all areas are covered except the metal parts and the head strap.
2. Leave the surface to dry and ensure a minimum contact time of 30 seconds.
3. Rinse the mask with Tristel® Duo OPH rinsing wipes.
Is the cleaning product Tristel® Duo OPH available in the Blephasteam® pack ?
No, Tristel® Duo OPH is not available in the Blephasteam® pack, it can be ordered on www.tristel.com
Can Blephasteam® be cleaned with other products than Tristel® Duo OPH ?
Tristel® Duo OPH is the only approved cleaning agent. Do not clean or wipe the mask (interior or exterior) with chemical products or solvent (e.g. acetone or ethanol). It may lead to discoloration or deterioration.
TECHNICAL QUESTIONS
Device
The blue Théa logo on the base is not lit
Maybe there is no power to the device, check if the main power outlet is not faulty and is switched ON, check also if the power cable on the back of the Blephasteam® is fully inserted.
The blue Théa logo on the headset is not lit
The headset is not correctly seated on the base station, lift up the headset and replace it carefully back on the base station.
The device status light is flashing orange and green
There is a temperature problem, remove the water carrier, unscrew the battery cover, and remove the batteries. Wait for 15 min with the device away from any heat source or draft, then replace the batteries, cover and screw. Return Blephasteam® to the base station and restart normally.
If the problem persists, contact Laboratoires Théa or www.blephasteam.com
The orange and green device status lights flashes alternately and the Théa blue light flashes
Blephasteam® has an internal fault, please contact Laboratoires Théa or www.blephasteam.com
There are some spots and marks that appear on the screen
This means that the mask is potentially faulty: a potential electrical interference is present within the system. If present, discontinue to use Blephasteam® and contact Laboratoires Théa or www.blephasteam.com for technical support.
Does Blephasteam® contain latex, phthalates or bisphenol ?
As requested by the EU regulations, Blephasteam® does not contain any latex, phthalates or bisphenol.
Does Blephasteam® require periodic maintenance for proper functioning ?
Periodic maintenance of Blephasteam® is not required by the user. Maintenance of the device is required when there is a malfunction or technical problem which is not solved with the troubleshooting solutions given in the Blephasteam® instructions for use.
Storage (How to use Page) ?
If Blephasteam® has been stored at a low temperature (-10°C), can we use it immediately ?
When Blephasteam® has been stored at -10°C or lower, unpack it and do not use before 1 hour until the device has reached ambient room temperature (around 20°C)
If Blephasteam® has been stored at a high temperature (40°C), can we use it immediately ?
When Blephasteam® has been stored at 40°C, unpack it and do not use before 40 min until the device has reached ambient room temperature (around 20°C).
Batteries
4 audible alert beeps followed by the green batteries light flashing.
Batteries are becoming drained; order new batteries and replace the old ones. The device can still be used.
The device status light is flashing orange and green, and the green batteries light is “ON” continuously
The batteries are drained, replace batteries with the new ones, the device in this case cannot be used.
References :
1. Pult H, et al. A comparison of an eyelid-warming device to traditional compress therapy. Optom Vis Sci. 2012 Jul;89(7)
2. Geerling G, et al. Emerging strategies for the diagnosis and treatment of meibomian gland dysfunction: Proceedings of the OCEAN group meeting. Ocul Surf. 2017 Apr;15(2):179-192
3. Kenrick CJ, et al. The Limitation of Applying Heat to the External Lid Surface: A Case of Recalcitrant Meibomian Gland Dysfunction. Case Rep Ophthalmol. 2017 Jan 16;8(1):7-12
4. Geerling G, et al. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64