S A F E T Y F I R S T

PURIFIED & FRACTIONATED SILICONE OIL

For better tolerance & higher safety

www.arcadophta.com

ARCIOLANE product specifications

Silicone oil safety issue

ARCAD response

Silicone oil for a long-term tamponade in the surgical treatment of a severe retinal detachment.

2 VISCOSITIES 2 PRESENTATIONS

ARCIOLANE 1300VIAL /

SYRINGEARCIOLANE 5500

THE EMULSIFICATION and CYTOTOXICITY are partially due to low molecular weight compounds present in the silicone oil. Emulsification can also be due to inflammatory proteins, red blood cells & plasma proteins present in the body.

LMWC (Low Molecular Weight Compounds), D4, D5, D6 are listed by the ECHA (European Chemical Agency) in the candidate list of substances of very high concern needing labelling above a concentration of 0.1% (w/w).

Thin layer vacuum purification process to remove low molecular weight polymers.

Separation of chains of different lengths, ARCAD only keeps long chains for reduced emulsification risk.

BEFORE TREATMENT

MIXED POLYMER CHAIN SIZES

FRACTIONATED SILICONE WITH LONG

CHAINS

AFTER TREATMENT

BEFORE TREATMENT

AFTER TREATMENT (25°C)

5000 mm2/s1000 mm2/s

5500 mm2/s1300 mm2/s

D4(Dimethylsiloxane)4

Safety facts of ARCIOLANE

A safe packaging designed for ophthalmic use

Arciolane: a quality conform to the highest demanding standards

• Manufactured in France

• More than 300.000 products distributed for the last 15 years

• Product used in more than 70 countries worldwide

• Low molecular weight polymers removal

• Specific sterile packaging for ophthalmic use

• 5 years shelf life accessories

• Adapted for all air pressure silicone oil injection systems

• Quality assurance system ISO 13485/2016 certified

*Average concentration of 1 year production

• Moulded glass syringe, non-silicone coated• Stainless steel luer-lock• Thick glass syringes• Plunger seal and specific stopper moulded in silicone rubber• Can be used up to 5 bars pressure

No chlorobutyl – No phthalate – No latex

MANUFACTUREDIN FRANCE

USED IN MORETHAN 70 COUNTRIES

LOW MOLECULAR WEIGHT POLYMERS

REMOVAL

FDA SPECIFICATION OF MARKETED

PRODUCT IN THE USRAW MATERIAL ARCAD FINISHED

PRODUCT

LMWCD4-D9 <200ppm <150ppm <10ppm*

5000 mm2/s

5500 mm2/s

ARCEOLE MONOBLUE OP’COVER

Ready-to-use setof ophthalmic gas

Ultra-purifiedtrypan blue

Bibliography on the website : www.arcadophta.com

Corneal protection

11 Rue Antoine Ricord - 31100 Toulouse - FRANCETél. + 33 5 61 40 52 35 - Fax + 33 5 61 40 84 66info@arcadophta.com

S A F E T Y F I R S T

Safety first for our product line

200A

AN

G 0

7 20

19-0

4

Complete choice of air pressure accessories to fit with your equipment

Quick and easy : instructions for useSterile set of air pressure tubing for Arcadophta silicone oil : 1- place the stopper into the syringe, 2- insert the cap enclosing the glass flange, 3- connect the line to the equipment

*Requires A 571 adapter

Reference Type of Connector Compatible with

ARC 510Steady

Male / FemaleLuer-lock

Harmony (Dorc) - Premiere (Storz)Antares (Opticon) - Penthasis (Ioltech)

SP3 (Oertli) - System (VF)

ARC 520 RotativeConstellation (Alcon)

Accurus (Alcon)Eva (Dorc)

ARC 530 Rotative Millenium (B&L)Stellaris (B&L)

ARC 540 Steady Orbit (Oertli)

ARCALINE - ARCOTANE

Heavy liquids for ophthalmic surgery