Owner’s guide, cleaning and maintenance of Fimco
Ophthalmic surgical instruments

Drapeau EN

I. Description

FIMCO instruments are ophthalmic medical devices aiming at performing surgical acts such as cutting, spreading, scratching, scraping, injecting or aspirating liquids or air, probing, dilating, storing, etc.

II. Indications

The instruments should be used in ophthalmic microsurgery by a qualified healthcare professional.

The instruments are used on all types of patients (adults - children - babies) who requires surgery and do not have any contraindications.

III. Contraindications

Allergies to:
- Nickel
- Titanium
- Austenitic steel
- Chrome

IV. Verification and maintenance

It is important to inspect the instruments after cleaning, search for any signs of corrosion, possible damaged surfaces, chips of material and contamination.

Instruments that are still contaminated must be cleaned and disinfected again.

Worn out, corroded or damaged instruments must be set aside, and should not come into contact with intact instruments to avoid corrosion contact.

It is the surgeon’s responsibility to check that the instrument is in good condition and in particular that there is no trace of corrosion.

Remember to lubricate the hinges as well as the joints with a lubricant for surgical instruments.

V. Warnings and Precautions

Any surgical residue adhering and drying on the instruments leads to corrosion. Prolonged exposure to moisture damages instruments.

Do not disinfect, clean, or sterilize instruments made from different materials together.

Use the instruments only for the functions for which they are intended.

Devices showing visible or functional signs of deterioration: worn out signs, shock marks, oxidation, stains, etc. should no longer be reused.

Fimco declines all responsibility in incidents linked to an intervention on the instrument by an unauthorized person. The warranty does not apply if the case of disassembly, modification or intervention is carried out on the instrument, only Fimco should intervene on these instruments.

Fimco shall not be liable to any direct or indirect injury suffered by the customer in the event of the inappropriate use, care, cleaning or sterilization of the medical device.

VI. Cleaning, disinfection and sterilization

Please note that the instruments are supplied NON-STERILE. They must be decontaminated, cleaned and sterilized before each use.

Sort the instruments by material then clean, disinfect and sterilize them separately.

1. Automatic cleaning

The following protocol must be observed for cleaning and disinfecting FIMCO instruments:

Phase Paramèters Product
Pre-wash Cold water (<30°C) 4 min None
Washing Soft water 55°C 10 min 10 mL/L (1%) Neodisher Septoclean*
Intermediate rinse Softened or demineralized hot water (>30°C et < 60°C) 3min None
Thermal disinfection Demineralised hot water 90°C 5 min None
Drying 20 min None

*or strictly equivalent product

2. Autoclave sterilization

Instruments must not be sterilized without first undergoing cleaning.

The machine manufacturer’s instructions and recommendations for use must be followed.

Instruments should be steam sterilized according to the following cycle:

Sterilization Parameters
134°C (293°F) for 18 minutes at a pressure of 2 bars

> Indicate on the sachet the date of sterilization and the expiry date in accordance with the data of the sachet manufacturer.

Attention !

Instruments with protection must be sterilized with it.

Be sure to use a box suitable for this sterilization method.

Make sure that the articulated instruments are in the open position to promote a homogeneous treatment.

VII. Storage conditions

Store the instruments in a clean, dry area where the ambient temperature is controlled between 15 and 30 ° C and a humidity of 30 to 70% RH, in order to avoid the risk of condensation in the packaging.

Do not store instruments near products or in an environment that may have a corrosive or magnetic action.

Instruments fitted with a protection keep it on the active part during the storage of the instrument.

VIII. Notifications

Any serious incident occurring because of the use of a device must be notified to FIMCO and the relevant Competent Authority.

15/10/2020 version HCE