INSTRUMANN Surgical instruments are delivered NON-STERILIZED.

Instruments should be Disinfected, Cleaned and Sterilized before each use.

 

·        The oil traces on the instrument require sometimes several washings. Do not hesitate to clean several times until the elimination of all oil traces.

·        Control each instrument and make sure of its good performance.

·        The Corroded instruments should be discarded immediately.

·        For cleaning, the dismountable instruments must be dismounted.

·        The chrome plated instruments must be separated from stainless steel instruments.

 

Decontamination:

·        Neutral decontaminating solution to be used by respecting the instructions indicated by the supplier, dosage and soaking duration.

·        Disinfection with sodium hypochlorite is proscribed. This disinfecting solution causes Stainless steel corrosion.

 

Avoid washing the instruments with a decontaminating solution.

Always carry out instruments decontamination followed by a cleaning.

 

Manual Cleaning:

·        Metallic brushes and abrasive sponges are proscribed.

·        Acid detergent is proscribed.

·        Rinse carefully with demineralized or distilled water.

·        Dry well immediately after rinsing.

 

Cleaning in Ultrasonic machine:

·         Delicate Instruments can be clean by ultrasonic treatment.

 

Washing Machine cleaning:

·         The detergents containing sodium hypochlorite are proscribed; these detergents cause stainless steel corrosion.

·         Acid detergents or detergents containing chlorine should not be used. Use only neutral detergents

·         Water must filtered and to have a TH between 5° and 7°.

·         Rinse carefully with a demineralized water.

·         Dry well and immediately after rinsing.

 

Maintenance :

·        Instruments articulations to be lubricated with medical paraffin oil.

·        Check the cleanliness and the good performance of each instrument after each cleaning.

 

Instruments must be sterilized before each use.

Sterilization is carried out only on clean Instruments.

 

Stérilisation :

·        Autoclaving is performed with saturated water steam at 134°C / 293°F during 18 minutes under a pressure of 2 bars.

·        Water must be of excellent quality, filtered, of a hardness TH not exceeding 7°, without Chlorine and chlorides < 1 mg/l.

Ø  Silica: < 1 mg/l.

Ø  Iron: < 0.2 mg/l.

Ø  Cadmium: < 0.005 mg/l.

Ø  Lead: < 0.05 mg/l.

Ø  Copper: < 0.1 mg/l.

Ø  Heavy metals except lead, iron, cadmium: < 0, 1 mg/l.

·         Instruments box must be suitable for sterilization.

 

 

Medical Device Vigilance

 

Materiovigilance (Medical Device Vigilance) defined by the French Public Health Code:

“The monitoring of the incidents or the risks of incidents resulting from the use of the medical devices after their marketing”

 

Materiovigilance (Medical Device Vigilance) comprises:

·         The description and the recording of the incidents or the risks of incidents.

·         The recording, the evaluation and exploitation of this information with an aim of prevention.

·         The realization of all studies or work concerning the safety of use of the medical devices.

·         The realization and the follow-up of the decided corrective actions.

 

In order to respect this procedure, we ask you to inform us about any incident or risks of incident which you could meet by contacting us by:

-          Fax : + 33 (0)320 757 927

-          E-mail : contact@medtek-corporation.fr

 

Many thanks for your co-operation.