Presentation of ophthalmic gas

Arceole is a ready-to-use injection set of ophthalmic gas C3F6 SF6 C2F6 for inner retinal tamponade. It facilitates the use of the gases in the operating theatre.

The single-use, apyrogenic sterile set comes with a validated 0.22 µm filter, syringe and cannula.

ophtalmic-gas-arceole-canisters

Improves safety

Asepsis is guaranteed and the mixture is facilitated for controlled manipulation by the surgeon or nurses.

ophtalmic-surgeon-nurse

Facilitates the air/gas mixture

The set is ready to use: it enables preparation of the gases for tamponade to be done by a single person.

easy-ophtalmic-surgery

Saves you time and money

  • A single person for preparation and injection.
  • Neither investment nor maintenance of equipment.
  • No purchase of accessories, nor surplus stock.
save-time-operation

Guarantees the quality of the mixture

Pressurised packaging guarantees the purity of the gas and the mixture throughout the product’s lifetime, and avoids the concentration of impurities as and when the liquefied bottled gas is used.

ophtalmic-gas-cannister-unidose

Also exists in MULDI-DOSE format

The set is composed of :

  • 1 reservoir containing 30 ml of non-sterile gas for ophthalmic use
  • 3 GS sets each containing 1 50 ml plastic syringe, 1 sterilising filter and the connection to the container
  • 3 patient wrist bands
  • 3 patient traceability labels.

Download the ARCEOLE MULTI-DOSE information leaflet.

Arceole_multidose

Accessories

Additional accessories for using Arceole ophthalmic gases, see the Accessories page.

ophtalmic-gas-Set1ml-cannister
ophtalmic surgery on video gr

Testimony

For me Arceole has two advantages:

  • safety: being able to have proof of having used a single-use system, in case of endophthalmitis, is an advantage.
  • the reproducibility of the gas concentration: when you use large bottles, there are differences in concentrations and hence in expansion of the gas to be injected depending on whether you are at the start of the bottle or at the end of the bottle. Here there is always the same concentration and hence better reproducibility.
Dr. Didier Ducournau, Clinique La Sourdille, Nantes, France
Didier-Ducournau-surgeon

General Indications

Product for inner retinal tamponade. Product for inner corneal tamponade in the event of a Descemet’s membrane detachment and lamellar keratoplasty.

Ophthalmic-gaz-arceole-choice-table

Note: the recommended method for avoiding loss of intraocular pressure remains suture. In fact, a 23-Gauge transconjunctival sutureless vitrectomy may lead to premature disappearance of the gas or to insufficient tamponade (see Kusuhara S & Al. Intraocular gas dynamics after 20-gauge and 23-gauge vitrectomy with sulfur hexafluoride gas tamponade. Retina. 2011 Feb;31(2):250-6)

ophtalmic-surgery-zone-gr

Instruction for use

ophtalmic gas arceole sf6 c3f8 c2f6INDICATIONS :

Product for inner retinal tamponade.  Product for inner corneal tamponade in the case of a Descemet’s membrane detachment and lamellar keratoplasty.

DESCRIPTION OF THE MEDICAL DEVICE

ARCEOLE consists of a sterile single-dose reservoir containing 30 ml of non-sterile gas for ophthalmic use and a sterile 50 ml plastic syringe graduated in ml, on which a 0.22 µm sterilising filter and an accessory enabling connection to the reservoir are mounted. Tolerance of the 50 ml syringe measurement is 4% of the measured volume.

A 30G needle is supplied for the intraocular injection. A patient wrist band identifies a gas wearer and a set of 5 patient labels enables traceability in the medical records. The PS SETs and 1 ml SETs are sold separately. The different ARCEOLE accessories have been validated for the use described below. It is highly inadvisable to substitute them with others.

Note: The PS SETs and 1 ml SETs come in a sterile blister containing a preassembled syringe with 0.22 µm filter and connector (PS SET, 5 ml syringe, 1 ml SET 1 ml syringe). They should be used according to the directions below. The 5 ml syringe measurement tolerance is 4% of the measured volume and 5% of the measured volume for the 1 ml syringes.

COMPOSITION

ARCEOLE is a single-dose reservoir of one of the three following gases: SF6 (sulphur hexafluoride), C2F6 (Hexafluoroethane), C3F89 (Octafluoropropane).

Each single-dose reservoir of ARCEOLE contains a non-sterile pure gas in sterile packaging. It does not contain latex or phthalates.

Note: the gases contained in ARCEOLE are inert, non-flammable, colourless and odourless non-toxic compounds.

Once implanted, they are not metabolised and are gradually eliminated through the blood, then the respiratory tract.

Compatibility with NMR imaging:  ARCEOLE is made up of perfluorinated compounds characterised by the absence of hydrogens; they therefore do not generate any signal.

Expansion and resorption rates based on the data of the literature:

Perfluoro-gases-specifications

CONTRA-INDICATIONS

Anaesthesia by inhalation of nitrous oxide must be stopped 15 minutes before the injection of the gas into the eye.

Any patient with a gas bubble must avoid anaesthesia with nitrous oxide for as long as the bubble is present and for at least 3 months following the date of implantation of the gas bubble. Serious post-operative complications which may go as far as blindness may arise in connection with the increase in intraocular pressure.

To remind them of these precautions the patient is invited to wear the wrist band provided in the kit.
Any patient who has had a gas bubble implant must avoid variations in pressure for as long as the gas bubble is present and for at least 3 months (altitude climbing, air travel, diving with or without an isobaric chamber, treatment by means of a hyperbaric chamber). The increase in pressure could lead to cases of blindness.

PRECAUTIONS AND WARNINGS

Gases for ophthalmic surgery are reserved for exclusive use by ophthalmologists trained in the use of this technique.

Although non-toxic, these gases compete with oxygen when inhaled. Therefore avoid any intentional inhalation of the gases.

A pre-operative gonioscopy is recommended. Avoid the use of pure gas in the case of a narrow iridocorneal angle. Monitoring of the central retinal artery during and after the injection is necessary. If an expansive gas is used, it is advisable to monitor the intraocular pressure while the gas is expanding.

It is recommended that a suture be placed at the end of a transconjunctival vitrectomy performed with a 23G incision in order to preserve the necessary watertight integrity for the action of the gas.

In case of a wide tear in the Descemet’s membrane, prevent the fish-egg effect by injecting the gas slowly with the cannula into the surface of the iris.

After implantation, a prophylactic anti-hypertensive treatment will be started and the PIO monitored daily.

Special monitoring will be given to patients with glaucoma or intraocular hypertension (IOHT), elderly persons, diabetics, patients with lesser tears which may increase the risk of a secondary tear, patients at risk of perioperative haemorrhage and patients with an indentation.

Generally speaking, the practitioner will first check the patient’s ability to keep his head in the position required for the treatment. The obligation to maintain the patient’s head in the required position may be relaxed if the posterior chamber of the eye is filled to 70% of its volume in the case of vitrectomies. The risk of onset of an iatrogenic cataract should be taken into account.

In the case of vitreoretinal surgery, ARCEOLE is a medical device designed to inject ophthalmic gas mixed with air. In the case of an injection of pure gas, on the practitioner’s responsibility, the latter must take into account the increase in the quantity of pure gas injected into the eye compared to the injection of a non-expansive mixture. Toxicity in relation to the dose effect and the duration of tamponade has been shown in rabbits.

COMPLICATIONS AND SIDE EFFECTS

The complications described in the literature are linked to the risks of ophthalmic surgery, more particularly:

Vitreoretinal surgery

  • passage of the gas under the retina; haemorrhage, hematoma, choroidal detachment; passage of the gas under the conjunctiva, passage into the anterior chamber (aphakic patients)
  • during the injection, injury to the crystalline lens or retina by the needle
  • risk of fragmentation of the gas or its capture between pars plana and crystalline lens
  • change in refraction
  • depression of the anterior chamber
  • reduction in the gas bubble in the case of a self-sealing incision
  • extension of the tear to the macula, inadequate position of the gas bubble (importance of adhering to the patient’s position during the injection)
  • modification of the vitreous body
  • retinal or vitreal capture at the injection site
  • condensation on silicone lenses in particular.

Possible secondary effects: occlusion of the central artery, hypertonia; secondary retinal tear, cataract, inflammation, endophthalmy, keratopathy, haemorrhage, vitreal reaction, macular hole, must be taken into account by the practitioner and weighed against the expected benefits.

Corneal surgery

Hypertonia, risk of fragmentation of the gas or its capture between the parts to be reapplied, infection, pupillary block.

In the case of an intra-chamber injection, caution is recommended if the patient wears an intraocular lens in hydrophilic acrylic, since an unexplained case of opacification was reported in the bibliography (SAEED MU, SINGH AJ, MOREL AJ, Sequential Descemet’s membrane detachments and intraocular lens haze secondary to SF6 or C3F8. Eur. J. Ophthalmol. 2006; 16; 758-60).

DIRECTIONS FOR USE

ATTENTION: since the gas is not sterile, it must be sterilised by passing through the sterilising filter supplied. The mixture must be produced extemporaneously.

Before using the syringe, it is recommended that plunger and syringe be detached by pulling on the plunger. Recover the needle placed in the syringe body, then slowly push back the plunger while expelling the air from the syringe body.

Position the syringe equipped with its filter and the connector above the valve and sink the tip of the connector into the valve vigorously.

The gas is liberated inside the syringe and pushes back the plunger; it is sterilised by passing through the 0.22µm filter.

Disconnect the syringe equipped with the filter and the adaptor from the reservoir by holding the reservoir and performing a sweeping movement from right to left; do not pull to separate them (the filter and connector must remain connected to the syringe).

Vitreoretinal surgery

Non-expansive mixture

The table below is given for information purposes to evaluate the concentrations:

 

Pull the plunger back to the desired quantity of pure gas, using the syringe graduations.

Aspirate air into the syringe to obtain the mixture in the desired proportions. The aspirated air is sterilised as it passes through the filter of the syringe.

Remove the filter from the syringe.

 

Quickly assemble the 30G sterile injection needle, retaining its cap; the mixture is ready for an intraocular injection.

Using pure gas: For information purposes, the injected volume, according to the bibliography, is between 0.3 and 0.6 ml for SF6, 0.4 ml for C2F6, and 0.3 ml for C3F8 (MATHIS A, PAGOT V. Tamponnements internes EMAC (Paris-France) Ophtalmologie, 1995 ; 21 248A –29, 10p).

 

Corneal surgery

In case of lamellar keratoplasty or reapplication of the Descemet’s membrane, the quantity of gas injected is around 0.25 ml, mixed with air at 20% for SF6 and 12% for C3F8.

The 1 ml SET is recommended for the injection of ophthalmic gas into the anterior chamber.

The table below is given for information purposes. to evaluate the concentrations:

Purge the SET 1 ml syringe of its gas contents once and repeat the operation as above.

Aspirate air into the syringe to obtain the mixture in the desired proportions. The aspirated air is sterilised as it passes through the filter of the syringe.

Remove the filter from the syringe.

Quickly assemble the 30G sterile injection needle while retaining its cap; the mixture is ready for an intraocular injection.

STORAGE CONDITIONS

Store the product in a properly ventilated place, away from any humidity and at a temperature of ≤25°C.

Do not use if the packaging guaranteeing sterility is not intact. Do not use after the expiry date.

Product for single use. The purity and sterility of the product are only guaranteed for a single use. Do not resterilise.

ELIMINATION OF WASTE:

STERILISATION METHOD:

The gas of which ARCEOLE is composed is not supplied sterile; only its packaging and the accessories are sterilised with ethylene oxide.

Date of the first EC marking: June 2003