Page 5 of 63 Pages
2. TECHNICAL DATA
2.1 Introduction
The table-top autoclave is pressure controlled automatically. It is
especially designed to meet the needs of effective and safe sterilization
in all kinds of dental and medical clinics, first aid rooms, small
laboratories etc.
The autoclave models M are electrically heated sterilizers of different
dimensions, using steam as the sterilizing agent.
It is easy to operate using the operating manual. Operator can choose
the required sterilization temperature range 212-273ºF (100-134ºC)
thus allow the instrument to be used as a sterilizer at 250ºF (121ºC) or
273ºF (134ºC). The low temperature range 212-250ºF (100-121ºC)
is designed to meet sterilization requirement when heat-sensitive
material is sterilized. The autoclave is specially designed for
sterilization of infectious waste materials prior to their disposal.
This manual is intended to give the user a general understanding of
how the autoclave works and indicate the best ways to operate and take
care of it in order to obtain optimum results and a trouble-free
operation. However, since the autoclave is built using high technology
sensitive components, no attempt should be made by the user or any
other unauthorized person to repair or re-calibrate it.
Only technical personnel having proper qualifications, and holding the
technical documentation and adequate test instrumentation are
authorized to service the instruments.
2.2 Operating Condition
This device is to be used for indoor use.
The sterilizer should be loaded only with autoclavable material.
The environment shall not exceed an ambient temperature of 40ºC and
a relative humidity of 85%.
2.3 Standards
2.3.1 Technical standards
1. A.S.M.E. Code, Section VIII div.1 for unfired pressure
vessels.
2. AAMI/ANSI ST-55:2001 Table-Top steam
sterilizers.
3. UL61010-1 General Safety.
4. UL61010-2-041 Particular Safety for Autoclaves.
2.3.1 Quality standards
1. EN ISO 9001:2000– Quality System
2. ISO 13485 – Quality systems – Medical devices –
Particular requirem
ents for the application of ISO 9001.
2.4 Storage conditions
The packed or unpacked autoclave shall be stored in “indoor
conditions” (protected from rain and water).
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