Documentos de Académico
Documentos de Profesional
Documentos de Cultura
Características
Técnicas
Los Esterilizadores de Vapor de PROHS tienen como su
base de funcionamiento el control de los parámetros
temperatura y presión visando la completa eliminación de
todos los microorganismos vivos.
La selección de componentes certificados y de alta calidad, permite una importante reducción de costes en el
transcurso de vida del equipo, así como una fácil sustitución de los componentes en cualquier agente de la marca.
PROHS está certificada por la norma ISO 9001:2008 - Sistema de Gestión de la Organización de la Empresa y la ISO
13485:2003 - Sistema de Gestión de Calidad para Fabricantes de Dispositivos Médicos, trabajando bajo todas las
normas de higiene y seguridad en el trabajo.
Consciente que la producción de dispositivos médicos requiere una posición de cuidado en la evolución de la
tecnología de los procesos productivos, PROHS invierte en investigación e intercambio de conocimientos, con esto en
mente, participa en estudios para mejorar los procesos de producción con Universidades y Laboratorios de referencia.
Standards
Product Description
PROHS TS-25 complies with following standards and codes:
PROHS TS-25 is a fully automatic high-speed pre & post vacuum
Steam Sterilizer. The unit is designed with similar features as a • EN 13060 for Small Steam Sterilizers;
Large Steam Sterilizer, extensively used in CSSDs’ and Operating • Medical Device Directive (MDD) 93/42/EEC;
Theaters (OT).
• Pressure Equipment Directives (PED) 2014/68/UE;
• ISO 17665-1:2006;
The sterilizer includes the following features:
• Safety and EMC Standards: EN 60601-1+ A1:93 + A2:95;
• Large capacity sterilization chamber
• EN 61010-1;
• Independent steam generator;
• EN 61010-2-040:05 ;
• Vacuum pump for evacuation of the chamber;
• EN 60601-1-2:01 (EMC) ;
• Electric double door locking system;
• EN 61326: 1997 + A1:98 + A2:01+ A3:03;
• Water reservoirs for process and used water retention;
• EMC Directive 89/336/EEC Article 7 (1);
• Water pump for water circulation;
• Quality Management System Standards: ISO 9001: 2008;
• Condenser and collector for condensation and collection of
water; • ISO 13485:2003;
• Temperature sensors and a pressure transducer to monitor both • EN ISO 14971 –Risk Management for Medical device
vacuum and pressurized states;
• Control valves operating at programmed intervals; Standard features
Construction and design
Application
• Chamber - The 25 liters sterilization chamber is made of one
As a Class B Sterilizer, the unit can process all types of loads as piece, reflecting the latest technology, Stainless Steel 316 L
specified in the EN13060 standard: wrapped, non-wrapped, solid, (conforms to the Pressure Equipment Directive (PED), jacketed. The
hollow load products type A and porous products. It can be used to steam is circulated through the steam heated jacket securing an
sterilize dental hand pieces, laparoscopes, wrapped surgical sets, uniform temperature instead of resistant heat which burns the
chambers. An automatic flush cleans the steam generator after
etc. For use in hospitals, private clinics and dental offices.
20/50 cycles from residues. This feature facilitates faster sterilization
cycles. External dimensions are especially suitable for small clinics.
Configuration and Options • Vacuum system –Equipped with a Diaphragm vacuum pump,
combined with a heat exchanger, and is a pre-vacuum sterilizer
Model Heating Doors having the following features:
□ PROHS TS-25 □ Electric, 220V, AC □ Single
- An air removal stage (pre-vacuum), before starting the sterilizing
Standard Accessories stage.
- A post-sterilization drying phase, based on the combined operation
□ One Stainless Steel Trays Rack
of heat and vacuum with air inlet pulses.
□ 4 Stainless Steel Trays (more trays are available upon request) In order to improve the efficiency of the vacuum pump – capability
and speed– a heat exchanger is installed on the outlet piping of the
Options chamber.
□ Impact Printer The advantages of the pre-vacuum sterilizer are as follows:
□ HMI PC Software - Removal of air pockets from packs and porous load and most kinds
of hoses (rubber, plastic etc.) by vacuum at the first stage of the
□ 1 Gigabyte SD Card & Reader
cycle.
□ Communication ports
- Better steam penetration into the load; resulting in effective
□ Reverse-Osmosis System sterilization.
□ Automatic water filling - Better temperature uniformity.
□ Automatic water draining - Better drying of materials due to the vacuum achieved in the
chamber at the end of the sterilization cycle.
• Safety Devices
Languages Numerous safety features including: a safety valve, thermostat,
The operator panel is set up with following standard languages temperature sensors, a water detection electrode in the steam
(maximum 5 languages per Sterilizer): generator, a pressure sensor, a safety pressure release valve,
a door locking device and software safety features.
• Door locking mechanism – The door system is automatic and
is based on a special locking device. The system is based on
two moving tongues located in the door pushed into a house
attached to the chamber.
The closing device prevents an incidental opening of the door if
there is pressure in the chamber. The moving tongues are
located in a slightly negative angle, in order to prevent shearing
off. The opening of the door can be done electrically only, in
case of power fail, the user can’t open the door without a
special tool.
• Water system – The sterilizers are equipped with 2 Water • Data collection – Sterilization cycles’ data can be collected
Reservoirs: one for mineral-free water and one for drain water. online trough standard RS232 connection, enables connecting
Water is circulated in the water pump and converted to the computer and the Sterilizer using the PC Software
saturated steam. (optional).
The Sterilizers are supplied as a stand-alone unit. A Reverse-
Osmosis water purification system is available in order to avoid Sterilization cycles’ data can be
the need to refill the water reservoirs. This system improves also collected online on a SD
the quality of the water used to generate steam. The use of Card through an optional SD
mineral-free water will contribute to better performance and Card Slot. Collected data can be
longer life of the Sterilizers’ chamber. downloaded into a computer
equipped with proprietary PC
Software. 1 Gigabyte SD card collects up to 20 years logging
• Energy saving mode - The Sterilizers are equipped with an data, including: the selected cycle, start time, cycle stages,
Energy Saving Mode which is activated if the Sterilizer is not temperature / pressure, end time, cycle status (pass / fail), etc.
used after a certain period of time. This Mode reduces power
consumption by approximately 12% to 30% and is thus An optional Ethernet Connection enables controlling, monitoring
environmental friendly. and connecting your PROHS TS-25 with no need of additional
software.
Cycle description
PROHS TS-25 offers 7 preset cycles: 5 sterilization cycles, and 2
test cycles. Up to totally 20 cycles can be custom designed by the
manufacturer.
The two available test programs are the Vacuum Test for checking
the integrity of the chamber and piping system and the Bowie & Dick
test which checks the efficiency of the sterilization process.
t1 = Conditioning
t2 = Sterilization stage
t3 = Exhaust and dry
stage 4 - Prion 134°C /18 min, 20 min dry
(Class B)
Sterilizing wrapped instruments.
Load weight <6 kg. With drying stage.
Cycle type (stated load types) Wrapped or non-wrapped, solid, hollow load products Type A
and porous products.
Specs PROHS TS-25
1 9 2 3 7
1 9 2 3 7
8
8
10
10
14
6
6
12 11 13 4 5
12 11 13 4 5
3 1 2 6 7 4 5
Optional-exhaust to external
1 Rear Cover 5 Reservoir
4 Over Flow