Sutter 701724 Manual Del Usuario página 8

English
Product / User / Disposal:
Medical devices may only be used and disposed of by qualified medical personnel!
Notwithstanding these instructions, reading the instructions for use provided with the stored instruments and
other accessories being used is mandatory.
Intended purpose:
Sutter storage trays are intended for the safe storage of suitable Sutter instruments during reconditioning in
a cleaning and disinfection device (CDD) and during sterilization in hot steam.
Service life:
A minimum of 100 reconditioning cycles can be expected with proper use.
Note:
For pre-cleaning, observe the instructions for use of the instruments being stored.
a T he instructions for use of the instruments being stored always take precedence over these instructions
for use.
8
Machine cleaning / Disinfection:
EN
In selecting the cleaning and disinfection device (CDD), note that the effectiveness of the CDD must have
been tested (DGHM ("Deutsche Gesellschaft für Hygiene und Mikrobiologie e.V.", German Association for
Hygiene and Microbiology) or FDA clearance for instance, or the CE marking according to EN ISO 15883).
The fundamental suitability of the storage trays for cleaning instruments in a CDD was proven with the
following program:
Program steps
Pre-rinse with cold tap water
Clean with 0.5 % deconex
Mid-cycle and/or final rinse with warm tap water (40-45 °C)
Rinse with deionized water
• Please note: The preceding instructions contain validated minimum times for successful cleaning with the
prescribed program steps. Deviating process parameters (longer cleaning time and higher cleaning tempe-
ratures up to 95 °C) do not damage the trays and are permitted according to the A
thermal disinfection at 90 °C, 5 minutes, comparable A
28 ALKA ONE-x (Borer Chemie) at 70 °C
®
value>3000. If a different cleaning agent is used,
0
Parameters
3 minutes
5 minutes
1 minute
1 minute
concept, for instance
0