User Manual Serie Castle

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If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.

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 :

130 160 180 250 330 420


555 670 740 825 900 1000 1250
* Sideways clearance distance is min. 75 cm.
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* 825 lt, 900 lt, 1000, 1250 lt sterilizers have 8 week delivery time.

* 130 lt, 180 lt models have only one sliding door.

* 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
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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.
Page 2 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.

PERSONNEL SAFETY FEATURES


In addition to the door safety systems, the chamber is
provided with a pressure monitoring system that
ensures that all chamber pressure has been relieved
prior to allowing the door(s) to open.

The fascia temperature never exceeds 55 °C.

MECHANICAL VACUUM PUMP


A highly efficient liquid ring vacuum pump, mounted on
vibration isolators for quiet operation, is provided to
effectively remove air from within the chamber.The
vacuum pump is connected in series to assist air
removal and protect the vacuum pump from excessive
temperatures. The vacuum pump is protected with alow
water alarm on the service water. STEAM SUPPLY

AIR FILTER Built-in Electrical Steam Generator


A disposable air filter is provided, for filtering of
Central Steam Supply
atmospheric air, entering the chamber. The air is used
to equalize the chamber pressure at the end of the
sterilization cycle. The filter separation efficiency is An automatic, integral, electrically heated steam generator
higher than 99,998% for particle size max. 0,3μm. mounted under the sterilizer chamber. The integral steam
generator pressure vessel is made of stainless steel,
insulated with 50 mm chloride free mineral wool enclosed
VALVES & COMPONENTS in a rigid removable aluminium sheet housing.The heating
elements are made of stainless steel.
All process valves are pneumatically operated piston
valves.All standard components are non-proprietary and WATER QUALITY FOR STEAM GENERATOR
easily sourced. Hot pipes are thermally insulated.
Please see below water connections.
PIPES & VALVES 1- Softener in water inlet connection for vacuum pump.
2- Revers Osmosis inlet connection for steam generator.
All piping and valves are made of stainless steel.
(Two of these connections are 3/4 '' )
Water quality will be equivalent of EN 285 : 2006 standard
in Annex B specifications.
Minimal water quality requirement for hardness is

< 0.02 mmol / l , conductivity is <5μS/cm.


WATER SAVING SYSTEM

Castle 'WATER SAVING' system is a water saving system


used to limit the consumption of the water utility during the
process, saves around 45-75 % of regular water consumption.
* Water saving system is not available in 130, 160 and 180 lt.
CT-SM_Rev_01_15_10_2015_EN

DRAIN COOLING SYSTEM


Please select ;

''Drain Cooling System''

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 modular PLC control system dedi-


(*) Our company has various design and several technical
cated to controlling of Castle sterilizers, including:
instrumentation. All future developments in products will be
Digital inputs and outputs for sterilizer informed. There may be differences between the same
control Analog measuring inputs product type or various versions.
COM ports for printer & PC communication OPERATOR PANEL ON CONTROL 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

• Steam generator pressure

• Jacketpressure

• Air pressure
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(All of them are monitored from touchscreen display)

• Steam Generator temperature

• Water saving tank


(These are monitored from loading side)

The temperature sensors are Pt-100.

Page 4 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.

Energy Saving (Standby) Programmable Sleep & Awake Time

The autoclave turns off jacket and steam • The autoclave turns on automatically
generator units when this mode is not use. at the set time,

• The autoclave warms up before personnel


starts to work,

• Time and Labor saving,

• Special hardware and automation


system

• 39 % - 75 % water saving

• 45 % - 69 % energy saving

Automatic Air Leak and Bowie & Dick Test

After warming up, the autoclave performs


air leak and bowie&dick test respectively
and automatically.
CT-SM_Rev_01_15_10_2015_EN

Page 5 of 13
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

SELF DIAGNOSTIC PROGRAM


The sterilizer is equipped with a set of pre-programmed cycles.
Siemens features a comprehesive alarm/alert system,
with automatic triggering of pre-programmable
information alerts(service intervals, maintenance etc). CYCLES INCLUDED

SIEMENS CYCLE DOCUMENTATION Standart Program Combination.

The six (6) included cycles are :


The Siemens supports following printing modes:
Data printout – numerical data. 1.Wrapped goods, textiles, porous load (134°C)
Cycle performance data is printed during the cycle and at For sterilization of medical devices, e.g. textiles, utensils.
cycle complete. The printed cycle information includes 2.Wrapped, heat sensitive material, rubber,
transition points, pressure and temperatures, cycle start plastic, porous load (121°C)
time, date both sterilizer and cycle number, and any
alarm that occurred during the cycle. In case of printer For sterilization of medical devices, e.g rubber, utensils.
failure during the cycle, the Siemens stores the cycle
data and can on demand reprint the last cycle. 3.Wrapped, heat sensitive material, instrument,
porous load (134°C)
Printer For sterilization of medical devices, e.g. instrument,
utensils.
Thermal printer is standard. 4.Wrapped, heat sensitive material, rubber,
plastic, porous load (125°C)
For sterilization of medical devices, e.g. rubber
INDEPENDENT CYCLE and plastic utensils.

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-
CT-SM_Rev_01_15_10_2015_EN

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.

Page 6 of 13
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)

3. Wrapped, heat sensitive material, instrument, Case (for sea freight)


porous load (134°C)

4. Wrapped, heat sensitive material, rubber,


plastic, porous load (125°C)

5. Bowie & Dick Test


6. Automatic leak test

ADDITIONAL CYCLES

Following additional cycles (password required) are available;


The Siemens PLC has 99 user adjustable programs.

Authorised users can program these adjustable programs by getting access using a pin code.
CT-SM_Rev_01_15_10_2015_EN

Page 7 of 13
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

Instruments 134 C° 134 C° 10 25 Instruments in Shelf or Container max. 7,5 kg

134 C° TEXTILE PROGRAM CYCLE GRAPH

CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD

Textiles 134 C° 134 C° 10 approx.25 Textiles max. 7.5 kg/pack


CT-SM_Rev_01_15_10_2015_EN

Page 8 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.

121 C° PLASTIC MATERIALS PROGRAM CYCLE GRAPH

CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD

Plastic 121 C° 121 C° 25 approx.10 Plastic materials max. 7.5 kg/pack

125 C° PLASTIC MATERIALS PROGRAM CYCLE GRAPH

CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD

Plastic 125 C° 125 C° 25 10 Plastic materials max. 7.5 kg/pack


CT-SM_Rev_01_15_10_2015_EN

Page 9 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.

AIR LEAKAGE TEST PROGRAM CYCLE GRAPH

CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD

Air Leakage - - - Device is empty, leakage limit max. 1.3 mbar / min.

AIR LEAKAGE

PRE PROCESS TEST PERIOD

PRESSUREBALANCE
10 MIN. WAITTING
5 MIN. WAITTING
PRE VACUUM

1.00 BAR . . . .. . ... .. . .. .. . .. .. . .. . . . .. ... ... .. .. ... .. ... . . . . .. .. .. . .. ... .. .. .


3 8 18 21 TIME
PRESSURE

70 MB
0 BAR

BOWIE-DICK TEST PROGRAM CYCLE GRAPH

CYCLE TEMPERATURE STERILIZATION TIME (min) DRYING TIME (min) RECOMENDED LOAD

Bowie – Dick Test 134 C° min. 3,5 approx.8 Bowie – Dick Test Pack
CT-SM_Rev_01_15_10_2015_EN

Page 10 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.

CT-SM_Rev_01_15_10_2015_EN

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

Castle article numbers are built up according to the following :


Smart / Smart S Model
Sterilizers Where ;

Castle Smart / Smart S models for Hospital Sterilizers

TR = Trans brand name


A = Autoclave
TM = Single motor sliding door
CM = Double sliding door
00X = Item number in pictures

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 :

Volume Clearance Operator Panel


Model Door Code Drawing ID
lt Distance location
Above
TS130EC1NX-C 130 TR-A-TM-002 min. 75 cm Chamber Door
TR-A-DKTK-01 Above
TS160EC1NX-C 160 min. 75 cm Chamber Door
TR-A-TM-002 min. 75 cm Above
TS180EC1NX-C 180 Chamber Door
(MANUAL OR MOTOR)

TS250EC1NX-C TR-A-TM-002 min. 75 cm Above


250 Chamber Door
SINGLE DOOR

TS330EC1NX-C TR-A-TM-003 min. 75 cm Above


330 Chamber Door
min. 75 cm Above
TS420EC1NX-C
SMART

420 TR-A-TM-003 Chamber Door


Above
TS555EC1NX-C 555 TR-A-TM-003 min. 75 cm Chamber Door
TS670EC1NX-C min. 75 cm Above
670 TR-A-TM-003 Chamber Door
TS740EC1NX-C min. 75 cm Above
740 TR-A-TM-003 Chamber Door
TS825EC1NX-C TR-A-TM-003 min. 75 cm Above
825 Chamber Door
TS900EC1NX-C min. 75 cm Above
900 TR-A-TM-003 Chamber Door
TS1000EC1NX-C 1000 TR-A-TM-003 min. 75 cm Left Of The Door

TS1250EC1NX-C 1250 TR-A-TM-003 min. 75 cm Left Of The Door

TS160EC2NX-C TR-A-DKCK-01 Above


160 min. 75 cm Chamber Door
TS250EC2NX-C TR-A-CM-001 Above
250 min. 75 cm Chamber Door
TS330EC2NX-C 330 TR-A-CM-002 min. 75 cm Above
Chamber Door
TR-A-CM-002 Above
(MANUAL OR MOTOR)

TS420EC2NX-C 420 min. 75 cm Chamber Door


SMART S

TR-A-CM-002 Above
DOUBLE DOOR

TS555EC2NX-C 555 min. 75 cm Chamber Door


TS670EC2NX-C TR-A-CM-002 Above
670 min. 75 cm Chamber Door
Above
TS740EC2NX-C 740 TR-A-CM-002 min. 75 cm Chamber Door
TS825EC2NX-C Above
825 TR-A-CM-002 min. 75 cm Chamber Door
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TR-A-CM-002 min. 75 cm Above


TS900EC2NX-C 900 Chamber Door
TS1000EC2NX-C 1000 TR-A-CM-002 min. 75 cm Left Of The Door
TS1250EC2NX-C 1250 TR-A-CM-002 min. 75 cm Left Of The Door

*Please refer the installation plans in our web site.


Page 12 of 13
If standard or optional boxes are not chosen, only standard (black) boxes are referenced for standard production.

Castle by Getinge provides value for money washer-disinfectors


and sterilizers that are compliant to international standards.
Our service network gives you reliable support you can depend
on for your daily operations. Castle by Getinge is a brand of
the Getinge Group.

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.

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