Produits Dentaires MAP System Directions For Use Manual page 7

Operation Operating mode
OR
4b Manual cleaning or assisted – Place the devices in a kit, box or container to
by an ultrasonic device avoid any contact between instruments.
– Immerse in the disinfecting solution with
cleaning properties, assisted by an ultrasonic
device if suitable.
5 Rinsing – Abundant rinsing (at least 1 min)
6 Inspection
– Inspect devices and sort out those with
defects.
– Assemble the devices (stops)
7 Packaging – Place the devices in a kit, box or container to
avoid any contact between instruments and
pack the devices in "Sterilization pouches".
8 Sterilization – Steam sterilization at : 134 °C / 273°F during
18 min. at 2, 1 bar.
– Check the success of the sterilisable cycle
(use physico-chemical indicator for each
performed cycle.)
9 Storage
– Keep devices in sterilization packaging in a
dry and clean environment
A1. Instruments
Warning
– No visible impurities should be observed on the instru-
ments.
– Discard any instruments with large obvious defects
(broken, bent, and twisted).
– Follow instructions and observe concentrations and time
given by the manufacturer (see general recommendations
under section 7).
– The disinfecting solution should be aldehyde free and wit-
hout di- or triethanolamines as corrosion inhibitor.
– Use quality water in accordance with local regulations.
– If a disinfecting solution contains a corrosion inhibitor,
it is recommended to rinse the instruments just before
the autoclaving.
– Dry on a single use non-woven cloth, or with a drying
machine or filtered compressed air.
– Dirty instruments must be cleaned and disinfected again.
– Discard instruments which show any deformations (bent,
twisted), damages (broken, corroded) or defects (loss of
color coding or marking) affecting the resistance, the
safety or the performance of the instrument.
– Check the validity period of the pouch given by the
manufacturer to determine the shelf life.
– Use packaging which are resistant up to a temperature of
141°C (286°F) and in accordance with EN ISO 11607.
– The instruments, posts and the plastic supports must be
sterilized according to the packaging labelling.
– Use only autoclaves that are matching the requirements
of EN 13060, EN 285.
– The sterilization protocol has been validated by Produits
Dentaires SA according to EN ISO 17665.
– Use only this recommended sterilization procedure.
– Control the efficiency (packaging integrity, no humidity,
color change of sterilization indicators, physico-chemical
integrators, digital records of cycles parameters).
– Traceability of procedure records.
– Sterility cannot be guaranteed if packaging is open,
damaged or wet.
– Check the packaging and the medical devices before
using them (packaging integrity, no humidity and
validity period).
Following
First use
uses
MAP System . Directions for use . 7