User Manual Serie Castle
User Manual Serie Castle
User Manual Serie Castle
CASTLE
SMART/SMART S
STEAM STERILIZER
PRODUCT SPECIFICATION
PRODUCT
The Castle Smart/Smart S is a fully automatic steam sterilizer.It has pre-set
programs for the most common sterilization processes for general purpose
hospital use. The program cycles employ mechanical air removal with a series
of vacuum/pressure pulses to effectively remove air for assured
sterilization.The chamber dimensions are adapted to sterilization, using wire
baskets according to ISO and STU or containers according to DIN.
APPLICATION
General-purpose steam sterilization of surgical instruments, textiles and hospital utensils in central
sterilization departments, operation departments and laundries. The temperature range is from 105°C–135°C.
CHAMBER VOLUME & SIZE CAPACITY The sterilizer chamber has a capacity of :
* 825 lt, 900 lt, 1000, 1250 lt sterilizers have 8 week delivery time.
* 1000 lt and 1250 lt have horizontally sliding door and not type tested.
Standard
Optional
1 STU = 600x300x300 mm
1 ISO = 600x400x200 mm
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
DOOR SELECTION
Single Door
Double Door
SERVICE ACCESS
Both Side Service
Right Side Service
Left Side Service The sterilizers are designed to comply with the
following requirements and standards :
*(Electric cabinet is always on back side and only on the right side
for 160 lt, single door.
Medical Device Directive 93/42/EEC as
amended by Directive 2007/47/EC
* 130 lt, 160 lt, 180 lt models are produced only both side Low Voltage Directive 2006/95/EC
service access. EMC Directive 2004/108/EC
Pressure Equipment Directive 97/23/EC
INSTALLATION SELECTIONS Sterilization - Steam sterilizes - Large
Sterilizers EN 285 : 2006
Recessed Through Wall (R)
Sterilization - Moist heat - Validation and
Cabinet Enclosure (C) routine control EN ISO 17665-1: 2006
ELECTRICAL COMPONENTS Quality Management Systems Requirements
Terminals, contactors etc. are housed in a cabinet.Other EN ISO 9001 : 2008
electrical components e.g. switches and valves are MedicalDevices-Qualitymanagement systems
mounted directly on the sterilizer. Requirements for regulatory purposes
EN ISO 13485:2012
**Sideways clearance distance needed. Environmental Management Systems Requirements
**Backwards clearance distance needed. with guidance for use EN ISO 14001:2004
VOLTAGE SUPPLY
CHAMBER DESIGN
Please refer to utility data table for correct amperage
380 VAC ± %10 The sterilizer chamber, jacket and door are made from
50 Hz solid, high quality type AISI 316 L/ W.Nr.1.4404 stainless
steel. Internal surfaces are treated with glass blasting to
60 Hz
facilitate cleaning.
LANGUAGE The sterilizer chamber is completely insulated with a 30-
Operator displays and operator & service manuals are 80 mm chloride free mineral wool, encased in a rigid
available in a selection of languages. Other information & removable aluminum sheet housing. The chamber is
manuals are in English. mounted on a stainless steel framework with adjustable
feet.
Turkish English Russian Spanish
VALIDATION CONNECTIONS
Polish Italian Czech Romanian
Greek French The chamber is provided with one 1/2" threaded con-
nection for optional vacuum/pressure gauge (PT) and a 1"
connection for test sensor (TT) on the left side as seen
CONFORMITY from control side.
Trans Sterilization is certified to develop, design and
manufacture CE marked (MDD) products for the health AUTOMATIC, VERTICALLY SLIDING DOOR(S)
care sector.
The door is fully automatic in operation and is raised and
CE conformity is required within the EC countries.
lowered by a motor. Door operation is controlled via push
CE & MDD conformity for e.g. hospital, dentist, buttons on the control panel. The door is automatically
CT-SM_Rev_01_15_10_2015_EN
clinic sterilization . sealed. Doors can not be open during the cycle. The
gasket is a silicon rubber 'O' ring. In the beginning
CE conformity related to research or waste of a process, the gasket is pressed against the rear face
sterilization. of the door by air. At the end of the process, the gasket is
retracted by vacuum and the door on the unloading side is
opened by a motor with gear box.
*Only 1000 lt , 1250 lt have horizontally sliding door.
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If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
Page 3 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
PRESSURE GAUGES
MAIN SCREEN
Pressure gauges in bar are provided for :
Chamber Pressure
Jacket Pressure
Gasket Pressure
Steam Generator
(There are as seen from loading side.)
The Siemens controls all system functions, moni- 7 colour touch screen
tors system operations, both visually and audibly 10 colour touch screen
alerts the operator of cycle malfunctions and, on Please select only one below choices ;
demand, provides visual indication of the chamber
* Lamp indicators are in unloading side.
temperature and pressure.
* 4.3'' screen is in unloading side.
*These options are valid only for double door sterilizers.
OPERATOR PANELS OPERATOR PANEL LOCATION
The control system is operated via an easy to use All models have operator panel above chamber door,
“menu tree”. As default, the operator has access to the only 1000 lt models have operator panel left side of chamber door.
cycle selection, cycle start and door control. Operators
TEMPERATURE AND PRESSURE SENSORS
can only run type-tested cycles.Access to other
functions, such as running test cycles, setting The Siemens control system has a built-in linearization,
parameters, calibration, service and maintenance is to correct the individual characteristics of each type of
controlled using a pre-defined Access levels preventing sensor connected to the system.
unauthorized access.
• Chamber Tempreture -1
• Chamber Tempreture -2
OPERATOR PANEL ON CONTROL SIDE
• Chamber Pressure -1
• Chamber Pressure -2
• Jacketpressure
• Air pressure
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Page 4 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
The autoclave turns off jacket and steam • The autoclave turns on automatically
generator units when this mode is not use. at the set time,
• 39 % - 75 % water saving
• 45 % - 69 % energy saving
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If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
NETWORK COMMUNICATION
ALARMS
Castle offers many ways to communicate with the
Automatic process checking and failure corrections are
sterilizers.Network communication will give you the ability
provided with the Siemens control system.In the event of
to connect with network applications.
an anomaly during the sterilization cycle, the process enters
an alarm phase which safely and automatically will end the Castle can also offer a stand-alone options where all
process automatically. cycle data can be stored on a USB stick.
RS 232 9 pin connection port
The range of alarms include :
Remote Access
Chamber high pressure
Low water level in generator
* If you select Remote Access,
Generator high pressure it supports Ethernet connection port.
Chamber Pt100 temp. sensor error
* Note : USB port on loading side.
Generator high temperature
Water pump operation time out
The independent cycle is using separate sensors, 5.Bowie & Dick Test
connected directly.
A test cycle adapted to the worldwide standard for chemical
Siemens is a completely independent monitoring and system indicators EN ISO 11140-1 for control of the air removal &
that constantly receives readings from Siemens and steam penetration of the sterilizer cycle.
compares them with own independent sensors.A
continuous cross check of the sterilizer safety system and 6.Automatic leaktest
the sterilization period according to the limit values in The sterilization process is sensitive to residual or
ingress of air into the chamber. If the chamber is not leak-
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EN-285 & EN-17665 is also performed. Siemens prints tight, sterilization efficacy may be impaired.
all process data on one printout, eliminating the need for a Castle sterilizers are equipped with a fully automatic leak
separate recorder. test process to confirm leak tightness of the chamber.
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If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
DRYING FEATURES
The included sterilization processes have a number of
post treatment options which can be fully adapted by the
end user to existing goods and local conditions, to achieve
an optimal drying result. * Castle sterilizers include 1 trolley and 1 rack for each single door.
CYCLES INCLUDED * Castle sterilizers include 2 trolleys and 1 rack for each double doors.
Program combination * Only 1000 lt , 1250 lt Castle sterilizers do not include trolley and rack,
it can be ordered with trolleys and rack as an option.
The six (6) included cycles are:
1. Wrapped goods, textiles, porous load (134°C) * 130 , 160 , 180 lt sterilizers do not have trolley and rack. They can
be ordered 1 trolley and 1 rack as an option.
2. Wrapped, heat sensitive material, rubber,
plastic, porous load (121°C)
ADDITIONAL CYCLES
Authorised users can program these adjustable programs by getting access using a pin code.
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If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
Program combination
134 C° SURGICAL PROGRAM CYCLE GRAPH
CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD
CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD
Page 8 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD
CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD
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If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD
Air Leakage - - - Device is empty, leakage limit max. 1.3 mbar / min.
AIR LEAKAGE
PRESSUREBALANCE
10 MIN. WAITTING
5 MIN. WAITTING
PRE VACUUM
70 MB
0 BAR
CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD
Bowie – Dick Test 134 C° min. 3,5 approx.8 Bowie – Dick Test Pack
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Page 10 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
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Page 11 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.
Smart/Smart S Models
The installation drawings differ depending on chamber size, type of installation, electrical clearance distance
(sideways or backwards), service side, number of doors and location of operator panel. The table below is
showing what installation drawings are present :
TR-A-CM-002 Above
DOUBLE DOOR
www.castlebygetinge.com
Legal Manufacturer:
TRANS MEDIKAL ALETLER SAN. VE TIC. A.S
Ostim(OSB) Mah. 1219. Sok. No:1
Yenimahalle- Ankara- Türkiye
Tel: + 90 (312) 385 77 20-36
Fax: + 90 (312) 385 71 00
info@transmedikal.com
www.transmedikal.com
GETINGE GROUP is a leading global provider of products and systems that contribute to quality
enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands
of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound
management solutions. GETINGE provides solutions for infection control within healthcare and
contamination prevention within life sciences. MAQUET specializes in solutions, therapies and products
for surgical interventions, interventional cardiology and intensive care.