Théa BLEPHASTEAM Bedienungsanleitung

Instructions for use |

EYELID WARMING DEVICE, MOIST HEAT TECHNOLOGY

Version: 2.6 - Release date 02/23/2021

INSTRUCTIONS FOR USE

Please read these instructions before use

EYELID WARMING DEVICE, MOIST HEAT TECHNOLOGY

| 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

| 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).

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

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: +33(0) 473 98 14 36

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

Andere Handbücher für BLEPHASTEAM

Inhaltsverzeichnis

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