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Manual

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.

A través de una rápida y uniforme transferencia de calor, los


Esterilizadores PROHS son una herramienta indispensable
en locales en donde es requerido elevadas exigencias de
esterilización.

La esterilización por vapor de agua saturado realizada por


los Esterilizadores PROHS es un método de esterilización
por excelencia, pues representa el sistema más seguro y
conocido, siendo efectivamente el medio más económico de
esterilización y el más utilizado en los hospitales.

Nuestros productos son fabricados de acuerdo con las


normas de seguridad y calidad, por técnicos certificados y
calificados. A lo largo de las diversas etapas de producción,
todos los productos son sometidos a pruebas y ensayos
rigurosos de conformidad con las normas y directivas
europeas, para garantizar su alta calidad y fiabilidad.

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.

Dimensions • Exterior - painted 2mm aluminium


Chamber:
Inner Dia. x Depth, 261 x 472 mm • Steam generator –Equipped with a stand-alone 2.9 kW steam
Chamber volume, net. 25 Litres. generator, made of Stainless Steel 316 L. The large capacity of the
External heaters enables steam to always be ready for operation, and thus
W x H x D, 534 x 475 x 609 mm contributes to a very fast cycle.

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.

The door system includes:

 Mechanical locking (2 tongues in two sides)


 Safety plate below the tongue on closing position, to hold
the tongues against shearing. • Operation – Operating is simple: close the door, select the
 Pull-type solenoid that in inactivated position locks the door cycle on the Touch-Screen Panel, and press the Start Key. The
and must be electrically powered to open the locking cycle will run automatically. At the end of the cycle, by pressing
device. the ‘Open Door’ button on the Touch-Screen Panel, the door
will automatically open.
 Micro switch (1) to indicate that the two tongues are in full
closed position.
 Magnetic Micro switch (2) to indicate that the door is
attached to the chamber frame (to let the motor pull the two • Printer – An optional impact printer can be supplied upon
tongues into the locking house) request. Each cycle can be documented by the printer which
 Micro switch (3) to indicate the door is locked. (Verifies that records the preset and actual parameters of the cycle: the
the tongues are above the safety plate, inside the locking selected cycle, cycle parameters, date, time, temperature,
house). pressure, errors, etc. The last 10 cycles’ data is automatically
stored in memory, and can be re-printed.
 Micro switch (4) to indicate when the door is open.
(Indicates that the tongues are out)of the locking house).

• 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.

• Control system / Touch screen panel – A state of the art


computerized control system includes a Microprocessor
controller and a Touch-Screen Panel LCD 5” with blue & white
graphic display, developed by world experts in the electronic
field. The control system ensures high reliability, simplicity,
safety of operation and automatic process cycles.

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.

 Sterilization temperature: 134 ºC, –0°C +3°C.


 Sterilization time: 18 minutes.
 Dry Time: 20 minutes.
 Vacuum pulses: 4.
 Average cycle time: 50 minutes.

1 - Flash 134°C /3 min (Warm Up).


6 - Porous 121°C /20 min, 20 min dry
(Class B)
Sterilizing unwrapped solid instruments.
Sterilizing Wrapped instruments.
Load weight <6 kg. Without drying stage.
Load weight <2 kg. With drying stage.

 Sterilization temperature: 134 ºC, –0°C +3°C.


 Sterilization temperature: 121 ºC, –0°C +3°C.
 Sterilization time: 3 minutes.
 Sterilization time 20 minutes.
 Drying time: 1 minute.
 Dry Time: 20 minutes.
 Vacuum pulses: 2.
 Vacuum pulses 4.
 Average cycle time: 15 minutes.
 Average cycle time: 50 minutes.

2 - Unwrapped 134°C /3 min (Class B)


7–Bowie and Dick test 134°C /3:30 min,
1 min dry (Hollow load A)
Sterilizing unwrapped instruments. This is a test program, with fixed sterilization parameters
134ºC and 3.5 min. drying time of 2 min. that cannot be
Load weight <6 kg. Without drying stage.
modified by the operator.

 Sterilization temperature: 134 ºC, –0°C +3°C.


 Sterilization temperature: 134 ºC, –0°C +3°C.
 Sterilization time: 3 minutes.
 Sterilization time: 3:30 minutes.
 Dry Time: 2 minutes.
 Dry Time: 2 minutes.
 Vacuum pulses: 4
 Vacuum pulses: 4.
 Average cycle time: 25 minutes.
 Average cycle time: 25 minutes.

3 - Wrapped 134°C /3:30 min, 20 min dry


8– Leak test (Vacuum test).
(Class B)
Sterilizing wrapped instruments.
The vacuum pump is activated until the pressure reaches a
Load weight <6 kg. With drying stage. level of at least 15 kPa, all the valves and pump shut down
(P1). The following 5 min. is for the stabilization condition of
the chamber (P2). From now on (P2) along the next 10 min.
 Sterilization temperature: 134 ºC, –0°C +3°C.
the allowable decrease of pressure is 0.13 kPa / m in. (or 1.3
 Sterilization time: 3:30 minutes. kPa for 10 min.)
 Dry Time: 20 minutes.
 Vacuum pulses: 4.
 Average cycle time: 50 minutes.
Technical data

Specs PROHS TS-25


Cycle type (according to EN 13060) B
External dimensions W x H x D 534 x 609 x 475 mm (21 x 18.7 x 23.9 inch)
Maximum depth (door open) 920 mm (36.2")
Chamber volume, net. 25 Litres. (6.1 gal)
Chamber shape Cylindrical 316L 1 part, no welding
Chamber Dimensions, Inner Dia. x Depth 261 x 472 mm (10.3 x 17.8 inch)
Weight, 70 kg (154.0 lb)
Shipping weight 80 kg (176.0 lb)
Shipping dimensions W x H x D 750 x 680 x 710 mm (29.5 x26.8 x 28 inch)
Mineral free water reservoir volume 6 Litres (1.32 gal)
Min. water quantity allowing the cycle 1 Litres
Max. water consumption during the cycle 0.6 Litres
Max. Water temp. at the reservoirs 65ºC (149ºF)
Max. Working pressure 2.7 bar (39 psi)
Min. Working pressure -0.9 bar (-13.5 psi)
Heaters power 2900W
Peak sound level 65 dB
Max. total Heating spread in 1 hour 4325 kJ
Max electric power (to 230 V) 2900W, 1 phase, 220V - 13A, 50/60 Hz
Voltage fluctuation ±10%
Operation Electronic with microprocessor
Controls Digital
Display LCD 5`` Blue/White Graphic Touch-Screen Multilingual, 240/128
pixel
Integrated printer Yes
Printer connection External printer connection only if the integrated is not in use.
Connection to PC Standard RS232, USB connection and Ethernet connection as an
option
No. of trays 4/6
Tray dimensions W x H x D 195 x 20 x 390 mm (7.2 x 0.8 x 15.4 inch)
Available trays optional Stainless steel trays 6 (184X 390mm) or 5 (200X390mm) or 4
cassettes (184X390X42mm)
Maximum load for tray 2.0 kg (4.4 lb)
Maximum solid load 6.0 kg (13.2 lb)
Maximum textile load 2.0 kg (4.4 lb)
Number of Cycles 7 cycles -5 sterilization cycles, 2 test cycles. can be increased to 20

Cycle type (stated load types) Wrapped or non-wrapped, solid, hollow load products Type A
and porous products.
Specs PROHS TS-25

Sterilization temperatures 134° - 121° C


Special / Test Cycles Bowie & Dick test; Helix test; Vacuum test
Air removal Fractionated vacuum
Drying system Vacuum
Suggested Cycle time (minutes) Total time: Flash134-(15min) unwrapped +hollow134(20mins) ,
porous 134 ( 35mins)
Stand-by Yes
Automatic switch-off protections (night cycle) Yes
Separate loading / unloading tanks Yes
Appearance of Face Plastic
Type of Closure painted 2mm aluminium
Automatic water filling Optional
Automatic water draining Optional
Automatic water draining Yes
Manual water filling and draining fully automatic door locking device,2 steps geared motor and
electromagnetic instead of manual handle
Door locking device Fractionated vacuum
Detailed interfaces
Front View

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

No. Description No. Description

1 Trays Holder 8 Air Filter

2 Tray 9 Fill water to reservoir

3 Door locker 10 RS232 PC communication port

4 Exhaust Filter 11 Leg

5 Water Reservoir Drainage 12 Door

6 Printer cover 13 Chamber

7 Operator Panel 14 Main Power switch


Rear view

3 1 2 6 7 4 5

No. Description No. Description

Optional-exhaust to external
1 Rear Cover 5 Reservoir

2 Power Inlet 6 Cut-off switch

3 Leg 7 Autoclave's main plate

4 Over Flow