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.