Ellipse Applicators – Instructions for Use · applicator. Therefore, the table below gives only...

Ellipse Applicators – Instructions for Use

1MAN8266 – A01 - ENG 1-1

Ellipse A/S Agern Allé 11 DK-2970 Hørsholm Denmark Telephone: +45 45 76 88 08 Fax: +45 45 76 88 89 Website: www.ellipse.com Publication date: 09-02-2014 Notice on Intellectual Property Rights

Ellipse A/S has been granted the following patents:

US 8.226.696: Main claim is directed to IPL combining water as a filter with a UV filter. Patent issued July 2012. (European patent pending – ref 98304722.6/ EP0885629)

EP2027827: Main claim is skin cooling by directional flow of cold air. Patent issued February 2012.

US 8.734.434: Main claim is skin cooling by directional flow of cold air. Patent issued June 2014.

Ellipse Applicators – Instructions for Use – Table of Contents

Table of Contents Chapter 1 Introduction ..................................................................... 1-1

1.1 About this manual ................................................................ 1-1

1.2 Applicators covered by this manual ......................................... 1-2

1.3 Consoles using applicators covered by this manual ................... 1-2

1.4 Applicator-Console compatibility ............................................. 1-3

Chapter 2 Treatment Guideline .......................................................... 2-1

2.1 Intended Use ....................................................................... 2-1

2.2 Contraindications .................................................................. 2-2

2.3 Adverse Effects .................................................................... 2-3

Chapter 3 Applicator Specific Information ........................................... 3-1

3.1 Applicators HR, HR-D, HR-S, HR-L+, HR+, HR-D+ ...................... 3-1

3.2 Applicators VL-2, PR, VL+, PR+................................................ 3-1

3.3 Applicators PL, PL-W, PL + ...................................................... 3-1

Chapter 4 Cleaning .......................................................................... 4-1

4.1 Applicator disinfection ........................................................... 4-1

Chapter 5 : Safety ........................................................................... 5-1

5.1 Introduction ......................................................................... 5-1

5.2 Warnings and Cautions .......................................................... 5-1

5.3 Eye protection ...................................................................... 5-2

5.4 Disclaimer ........................................................................... 5-3

5.5 General precautions .............................................................. 5-3

5.6 Symbols and labels found on the IPL applicator ........................ 5-4

5.7 Labelling (CE Conformity) ...................................................... 5-5

5.8 IEC Symbols used ................................................................. 5-5

Chapter 6 : Technical Specifications ................................................... 6-1

6.1 General Specifications ........................................................... 6-1

Part Numbers ............................................................................ 6-1

Operating Conditions – All Applicators ........................................... 6-1

Foot Print (spot size) - Overview .................................................. 6-1

6.2 Applicator Specifications ........................................................ 6-2

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Ellipse Applicators – Instructions for Use – Table of Contents

Table of Figures

Fig 1. Position of light guide and housing .......................................... 4-1 Fig 2. Inspect the applicator for trapped air ...................................... 5-3

ii 1MAN8452-B05-US

Ellipse Applicators – Instructions for Use – Introduction

Chapter 1 Introduction

1.1 About this manual Reading this manual will help to ensure your Ellipse system – the console and the applicators - will give you years of trouble-free service; it will help you to protect your investment as well as safeguarding your clinic and your clients.

These devices are intended to be used only by persons who have a thorough knowledge and understanding of skin conditions and of light-skin interaction. It is the obligation of the user of these devices to follow all national, state and local regulations regarding treatments performed with these devices.

This manual contains essential information regarding the safe use of your Ellipse applicators. Safe use depends on a safe attitude as well as recognizing the potential safety risks that exist if the correct procedure is not carried out. In order to reduce the likelihood of injury to the patient, practitioner or service personnel, or equipment damage, it is important to read this manual before connecting the applicator, and review the procedures and safety precautions frequently. Please also refer to the Safety Instructions in the console manuals before use.

The guide gives information on:

• Applicator Models and Compatibility • Intended Use • Contraindications • Adverse Effects • Safety and Hazards • Maintenance • Cleaning and hygiene • Working conditions and temperatures • System labelling and conformity • Technical Specifications

Much of the information (for example cleaning) is true for all applicators, but some is highly specific. Therefore, please check Chapter 3 Applicator Specific Information of this guide for extra information on the specific applicator you will be using.

Throughout the document, cross-references to other chapters of the same document will be shown in the form “See Chapter X: Heading”. Cross-references to other sections will be shown in the form See Section X.Y.Z: Heading. Cross-references to Figures will be shown as “See Fig. Y”. References to other documentation produced by Ellipse A/S for your Ellipse system will be in bold text.

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Contact your Ellipse representative if you have any questions.

1.2 Applicators covered by this manual This manual covers the following applicators manufactured by Ellipse A/S:

HR HR-D HR-S HR-L+ HR+ HR-D+ VL-2 VL+ PR PR+ PL PL-W PL +

In 2009/2010, Ellipse A/S launched a series of new applicators (the PLUS or + Series). These offer a longer (guaranteed) lifetime, lower running costs, and a design that offers greater operator comfort and greater flexibility, than the applicators they replace. Like the HR-3, the +series applicators work on a pay per shot basis, and require a special USB device, called a dongle, to enable them to work.

HR, HR-D, HR-S, VL-2, PR, PL, PL-W: Standard lifetime, no dongle HR+, HR-D+, HR-L+, VL+, PR+, PL +: Extended lifetime, dongle

The dongles are color coded:

Red + Series Applicators (Microlight Systems) Green + Series Applicators (systems other than Microlight)

1.3 Consoles using applicators covered by this manual This manual covers the following consoles manufactured by Ellipse A/S:

Ellipse MultiFlex / MultiFlex+ (REF 9ESF7496)

Ellipse I2PL / I2PL+ (REF 9ESL7228)

Ellipse Microlight HR (REF 9EMA7565)

Ellipse Microlight Pro (REF 9EMA7631)

Ellipse Flex PPT (REF 9ESF7255)

Not every applicator is compatible with every console. The tables overleaf show the compatibility:

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1.4 Applicator-Console compatibility Original applicator series

HR* HR-D HR-S VL-2 PR PL PL-W MultiFlex MultiFlex+ I2PL I2PL+ Light SPT Light SPT+ Microlight HR Microlight Pro Flex PPT

*The HR applicator is no longer produced, but is still supported.

New + applicator series HR+ HR-D+ VL+ PR+ HR-L+ PL + MultiFlex MultiFlex+ I2PL I2PL+ Light SPT Light SPT+ Microlight HR Microlight Pro Flex PPT

Key Compatible Requires Upgrade Not Compatible

If you would like further information on upgrades, please contact your local Ellipse sales representative or distributor for details.

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Ellipse Applicators – Instructions for Use – Treatment Guideline

Chapter 2 Treatment Guideline

2.1 Intended Use The console to which it is connected defines the intended use of an applicator. Therefore, the table below gives only an outline of the intended use of the various applicators. See the appropriate console manual for further information.

Application Treatment Variable Fitzpatrick Skin Type

1 2 3 4 5 6

Hair Removal

HR, HR-S, HR+, HR-L+ Applicators

Hair Thickness (Thin, Normal, Thick)

Hair Removal

HR-D, HR-D+ Applicators Hair Thickness (Thin, Normal, Thick)

Telangiectasias – Face

VL-2 , VL-2 +, PR, PR+ Applicators

Vessel Size (Thin Medium Thick)

Port Wine Stains

VL-2 , VL-2 +, PR, PR+ Applicators

Color (Red, Blue)

Individual Pigmented Lesions

PL, PL–W, PL+ Applicators Lesion Color - (Light, Medium, Dark)

Treatment of Benign Pigmented Lesions(e.g. ephilides, mottled pigmentation) and Benign Vascular Lesions (e.g. diffuse redness)

VL-2 , VL+, PR, PR+ Applicators

Pigmentation, Vessel Size

Poikiloderma of Civatte


Skin

Rosacea


Skin

Treatment of inflammatory acne

PR, PR+ Applicators Skin

Key: Allowed on approved system; Not Allowed

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2.2 Contraindications It is not possible for this document to give a future-proof set of contraindications. The rate of production of new drugs (medications) means that new information on drugs (and combinations of drugs) appears daily. Most countries have an up-to-date register of drugs and their side effects, including photosensitivity. If in doubt, the user should seek expert medical opinion from those with the ability to research the effects of disease and genetic conditions, and further to research the side effects of medication. Such information can also be obtained by e-mailing [email protected].

Currently known contraindications are:

● Clients with any disease or genetic condition causing photosensitivity.

● Clients undergoing treatment with anticoagulants (anti-clotting drugs) or any medication causing sensitivity to light.

● Clients suffering from long-term diabetes or hemophilia.

● Clients tending to produce keloids (abnormal amounts of scarring) or hypertrophic scarring (raised red scars).

● Clients with sun-tanned skin.

● Client with fever.

● Clients taking topical or systemic steroids, or taking non-steroidal anti-inflammatory drugs (NSAID). These actively work against the treatment.

● Clients who have received gold injections where there has been some leakage / spillage into the epidermis. This presents as an area of dark grey tissue, which will absorb the light energy.

● Permanent make-up (dark colors in particular) will absorb the light energy and the client may feel a burning sensation (with burns in worst case). These areas must be excluded from treatment. This is also the case if the client has a tattoo.

Contraindication notes

Although not specifically contraindicated, clients who are pregnant or who have a heart pacemaker fitted are normally not treated.

Clients with any sort of implants in the treatment area should be treated with care. Modern silicone implants produce little risk, but metal implants, such as plates or screws used on broken bones can heat and expand, causing significant discomfort.

Most countries provide a web-based list of drugs and their side effects, and similar information can be found at www.drugs.com. If in doubt, seek expert advice.

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Area containing fillers or fat injections may be affected by heat from the light exposure.

Refer to 1MAN8455 for additional information on

• Contraindications, adverse effects and treatment notes related to other specific treatments or groups of treatments.

2.3 Adverse Effects The risk of adverse effects (side effects) following treatment is low. The main side effect may be burns. The risk can be minimized by doing the following:

● The client should avoid sun exposure during and within one month of the end of the course of treatment. This minimizes the risk of hypopigmentation or hyperpigmentation.

● The risk of an adverse pigmentation effect after treatment is also higher if the client has a tan, regardless of if this is from the sun, a solarium or a tanning solution. The best results are achieved if treatment is postponed a few weeks to lose the suntan.

● Keep the applicator light guide free of dirt and hair (this reduces the risk of burn marks on the skin).

● Treat darker skinned clients (skin type 3 and especially types 4 to 6) with caution, allowing extra time to see the results of a test shot, and only increase from the default energy slowly and with care (this reduces the risk of blistering, hypopigmentation and hyperpigmentation). These clients must be extra careful to avoid sun exposure.

● Blisters or superficial burns may be caused if too high energy is delivered to the skin surface. Melanin in the epidermis will absorb part of the light energy and heat will be produced. The likelihood of thermal adverse effects in the epidermis is greater with darker skinned clients, because of the higher concentration of melanin in the epidermis.

● Caution: Lower energy should be applied over bony areas as these are at higher risk of adverse effects, since the light is reflected back from the bone.

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Ellipse Applicators – Instructions for Use – Applicator Specific Information

Chapter 3 Applicator Specific Information

3.1 Applicators HR, HR-D, HR-S, HR-L+, HR+, HR-D+

Hair treatment of pregnant clients is most successful 2-3 months after birth, as growth of body hair is synchronized at this time.

For hair removal, the curved light guide must be applied with pressure to squeeze the blood out of the underlying vessels. This reduces the risk of light energy being absorbed by the competing chromophore oxyhemoglobin, and makes the treatment safer and more efficient.

During treatment, the client must wear protective goggles (REF 2EYE0801/2EYE7140) and operator and bystanders must wear green protection glasses (REF 2EYE0800 or 2EYE7138).

3.2 Applicators VL-2, PR, VL+, PR+ To obtain maximum results on any treatment where the target is hemoglobin, advise the patient to avoid smoking in the 4 hours before treatment.

For any treatment where the target is hemoglobin, the curved light guide must gently touch the skin without pressure to avoid squeezing the blood out of the underlying vessels.

Always check the skin carefully for darkening of pigment before performing a delayed second pass (with the same or another applicator). To avoid skin burns postpone the treatment by at least 3 weeks even when only a small darkening of pigment can be noted.

During treatment, the patient must wear protective goggles (REF 2EYE0801/2EYE7140) and operator and bystanders must wear blue protection glasses (REF 2EYE7002/2EYE7139).

3.3 Applicators PL, PL-W, PL + Avoid treating normal skin without pigmented disturbances, with Pigmented Lesions settings, as the emitted waveband could easily lead to small skin burns.

For treatment of pigment, the curved light guide must be applied with pressure to squeeze the blood out of the underlying vessels. This reduces the risk of light energy being absorbed by the competing chromophore oxyhemoglobin, and makes the treatment safer and more efficient.

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Ellipse Applicators – Instructions for Use – Applicator Specific Information

Always check the skin carefully for darkening of pigment before performing a delayed second pass (with the same or another applicator). To avoid skin burns postpone the treatment by at least 3 weeks even when only a small darkening of pigment can be noted.

During treatment, the patient must wear protective goggles (REF 2EYE0801/2EYE7140) and operator and bystanders must wear blue protection glasses (REF 2EYE7002 or 2EYE7139).

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Ellipse Applicators – Instructions for Use -Cleaning

Chapter 4 Cleaning

4.1 Applicator disinfection It is essential that any areas that come into direct contact with the client should be regularly inspected, cleaned and disinfected. This applies particularly to the light guide and the light guide housing.

Between patients, the light guide and the light guide housing should be wiped with a mild soap solvent, followed by disinfection using 70% IPA (Isopropanol alcohol – C3H8O) impregnated wet wipes.

At least daily, visually inspect the applicator for any signs of damage.

Once a week all applicator surfaces should be disinfected.

Fig 1. Position of light guide and housing

Light guide

Light guide housing

Trigger

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Ellipse Applicators – Instructions for Use - Safety

Chapter 5 : Safety

5.1 Introduction This chapter contains important information concerning potential hazards and general safety precautions. Contact your Ellipse representative if you have any additional questions.

Risks are separated into general risks from using the system and specific risks associated with certain treatments or aspects of the treatment. Importantly, safety risks are broken down into warnings and cautions, described below.

5.2 Warnings and Cautions Warning is used to identify conditions or actions for which a known hazard may cause severe personal injury, death or substantial property damages if the instructions are ignored

Caution is used to identify conditions or actions for which a potential hazard may exist which will or can cause minor personal injury or property damage if the instructions are ignored.

Warning: Do not perform a treatment outside the specified intended use, or on a client outside the approved client parameters.

Warning Safe and efficient treatment requires that the user of this product has read this manual as well as the manual(s) for the consoles with which the applicator is to be used, and follows the instructions contained in these manuals.

Warning: Do not use the applicator in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide.

Warning: Do not flash the light in the proximity of flammable materials. Note: such materials may be liquid (e.g. alcohol swabs) or solid (e.g. dark clothing).

Warning: Never direct the Light guide towards the eye. Aim away from the eye and regard the cheekbone as the highest point that can be treated.

Warning: Due to electrical safety requirements, the applicator must only be refurbished by Ellipse A/S or Ellipse authorized distributors.

Warning: Do not use an applicator with a chipped or damaged Light guide.

Caution: Proper evaluation of client skin type and pigmentation is necessary for efficient, safe operation. It is therefore vital that a thorough dermatological examination is carried out prior to any treatment.

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Caution: Warn all personnel present before triggering flash lamp.

Caution: Never leave a client unattended with the system in ready mode.

Caution: Only use the applicator with an approved and tested optical coupling gel. (Ref 2GEL0826 (250g) or 2GEL1342 (5kg)).

Warning: Never use the applicator, if it appears to be leaking water, or if a safety problem is thought to exist.

Warning: No part of the area to be treated should be covered with any metal foil. When exposed to light radiation, foil may heat up and cause epidermal damage.

Warning: Do not apply heat to the area being treated.

Caution: Due to the reflection of the light from the bones, it is recommended to reduce energy when treating over bony areas. Attention should also be paid to areas with thinner skin. At all times, the operator must monitor skin reaction and get feedback from client on comfort.

5.3 Eye protection Warning Your Ellipse applicators emit high energy, broad-spectrum light flashes that could cause severe eye damage. During treatment, the operator, patient and bystanders must wear protective eyewear of the type recommended for the selected treatment.

Protective eyewear must be of a quality corresponding to the EN 207 Standard.

Eyewear Type

Cut-off wavelength Marked (color)

Ellipse Part no.

Patient Goggles Provides complete optical protection

2EYE0801 or 2EYE7140

Operator Eye protection

(Hair removal)

615-720 nm: OD >3

600-615 nm: OD >2

Green 2EYE0800 or 2EYE7138

Operator Eye protection

(Other than Hair removal)

530-710 nm: OD >2

Blue 2EYE7002 or 2EYE7139

.

Warning Never direct the Light Guide towards the eye. Aim away from the eye and regard the cheekbone as the highest point that can be treated.

Note: If necessary, move skin to be treated down over the cheekbone or up over the frontal cranial bone to use the bone as an additional shield.

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5.4 Disclaimer The applicator shall comply with the EU Medical Device Directive 93/42/EEC (amended) and with all US Federal regulations and applicable standards and shall comply with the approved technical specifications (see section Technical specifications).

Ellipse A/S can only ensure continued compliance if repairs of the applicator and required periodic refurbishments of the applicator are performed by Ellipse personnel or by Ellipse trained and authorized personnel.

Use of high quality and original parts is crucial to ensure continued compliance. A number of parts are listed on critical component lists of the products’ safety tests. The safety test certificates are only valid as long as Ellipse uses the specified parts.

Ellipse A/S does not guarantee continued compliance and safety of the products if the above considerations are ignored.

5.5 General precautions Do not attempt to operate your Ellipse system without an applicator connected.

Air bubbles trapped in the applicator must be removed before releasing the first shot - if not the applicator may stop working after a few shots.

Fig 2. Inspect the applicator for trapped air

To remove trapped air, switch on the System and turn, gently shake, raise and lower the applicator. Continue this procedure until air is completely removed from the applicator. Visual inspection is possible through the light guide, as shown in Fig 2 above.

Always reposition the applicator in the holder when not in use. Always stop the treatment before replacing the applicator.

! Warning All areas that come into direct contact with the patients should be regularly cleaned and disinfected. Improper cleaning may result in epidermal or equipment

1MAN8452-B05-US 5-3


damage. This applies particularly to the light guide and the applicator. (See Chapter 4 Cleaning.)

5.6 Symbols and labels found on the IPL applicator

1 Optical Radiation Aperture

2

Warning against Powerful Light radiation from the applicator. Avoid direct eye exposure. See accompanying documents.

3 Risk Group 3 / EN60601-2-57:2011 Max. radiated energy: 26J/cm2 Pulse duration range: 2.5-99.5 ms Wavelength range: 400 nm-950 nm WARNING: The light emitted may result in eye injury Do not look at the light source.

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5.7 Labelling (CE Conformity)

0543

Your Ellipse applicator conforms to the requirements of council directive 93/42/EEC (amended) concerning medical devices and therefore bears the CE mark of Conformity:

Safety classification of the devices to which these applicators are connected is found in 1MAN8454.

5.8 IEC Symbols used

This product should not be disposed of as normal waste, but should be sent to an authorized centre for recycling (EU regulation)

Manufacturer: Ellipse A/S Agern Allé 11, DK 2970 Hørsholm, Denmark Phone: (+45) 45 76 88 08 Fax: (+45) 45 76 88 89 E-mail: [email protected]

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Ellipse Applicators – Instructions for Use - Technical Specifications

Chapter 6 : Technical Specifications

6.1 General Specifications Part Numbers HR (REF 9APP7133) HR-L+ (REF 9APP7633) HR-D (REF 9APP7114) HR+ (REF 9APP7670) HR-S (REF 9APP7116) HR-D+ (REF 9APP7672) VL-2 (REF 9APP7134) VL+ (REF 9APP7676) PR (REF 9APP7213) PR+ (REF 9APP7674) PL (REF 9APP7212) PL + (REF 9APP7699) PL-W (REF 9APP7377)

Operating Conditions – All Applicators Working temperature 10–35oC (50-95 oF)

Storage temperature (drained) 0–40oC (32-104 oF)

Relative humidity non-condensing 10–75%

Atmospheric pressure 700–1060 hPa

Foot Print (spot size) - Overview HR-S, PL Ø8mm HR, HR-D, HR+, HR-D+, VL-2, VL+, PR, PR+, PL-W, PL + 10mm x 48mm HR-L+ 18mm x 48mm

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6.2 Applicator Specifications

All Max Dimensions ( d x w x h ) 255 x 73 x 40 mm

Max Weight incl cable (drained) 1.2 kg

HR Wavelength range Output (max) Foot print (spot size)

600-950nm 21 J/cm2

10mm x 48mm

HR-S Wavelength range Output (max) Foot print (spot size)

600-950nm 16.5 J/cm2

Ø8mm

HR+ Wavelength range Output (max) Foot print (spot size)

600-950nm 21 J/cm2

10mm x 48mm

HR-L+ Wavelength range Output (max) Foot print (spot size)

600-950nm 21 J/cm2

18mm x 48mm

HR-D Wavelength range Output (max) Foot print (spot size)

645-950nm 18 J/cm2

10mm x 48mm

HR-D+ Wavelength range Output (max) Foot print (spot size)

645-950nm 18 J/cm2

10mm x 48mm

VL-2 Wavelength range Output (max) Foot print (spot size)

555-950nm 26 J/cm2

10mm x 48mm

VL+ Wavelength range Output (max) Foot print (spot size)

555-950nm 18 J/cm2

10mm x 48mm

PR Wavelength range Output (max) Foot print (spot size)

530-750nm 18 J/cm2

10mm x 48mm

PR+ Wavelength range Output (max) Foot print (spot size)

530-750nm 19 J/cm2

10mm x 48mm

PL Wavelength range Output (max) Foot print (spot size)

400-720nm 18 J/cm2

Ø8mm

PL-W Wavelength range Output (max) Foot print (spot size)

400-720nm 18 J/cm2

10mm x 48mm

PL+ Wavelength range Output (max) Foot print (spot size)

400-720nm 18 J/cm2

10mm x 48mm

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1MAN8452-A02-US 6-1


0543 Ellipse A/S Agern Allé 11 DK-2970 Hørsholm Denmark www.ellipse.com Telephone +45 45 76 88 08 Fax +45 45 76 88 89

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