PRODUCT SPECIFICATION

PRODUCT

Large Steam Sterilizer DGM AND series

Capacity 100-150 Liters

APPLICATION
Sterilizer of the DGM AND type with
rectangular prism-shaped, horizontally
positioned sterilizing chamber, is designed for
sterilizing with water steam such medical items
as: surgical instruments, operating clothes,
dressing materials, infusion liquids, rubber
products, culture media etc.

MODEL SELECTION
= Standard O = Optional
MODEL & DIMENSIONS
Model Chamber Size Chamber Dimensions
wxhxd Volume wxhxd
mm ltr mm
100-2 400 x400 x650 103
800 x 1615 x 900
100-1 400 x400 x700 109
150-2 400 x400 x950 150
800 x 1615 x 1200
150-1 400 x400 x1000 156

DOOR SELECTION
Single Door (-1)
Double Door (-2)
VERSIONS

Right (Control panel and electrical box on

the right side) The sterilizer’s chamber and heating jacket are
o Left (Control panel and electrical box on made of high quality, stainless steel 316L.
the Left side)
The chamber door is made of the same quality
ELECTRICAL SUPPLY steel 316L and it moves vertically with the help of an
electric actuator.
380-400V, 3Ph, 50/60 Hz
o 200-230V, 3Ph, 50/60 Hz The chamber is sealed by a movable compressed
PIPING air-driven silicon gasket.
copper/brass piping and valves Air removal and drying are made possible by a
o stainless steel piping to chamber and very efficient system based upon using a water-ring
jacket – triclamp fittings vacuum pump and a condenser.
STEAM SOURCE Valves – Pneumatic control valves are used for
precise control of steam flow in and out of the
built-in steam generator chamber and jacket.
o external source of steam
Drain Tempering – Condensate is cooled to below
LANGUAGE (SELECT ONE) 60°C before being discharged
English The microprocessor controller assures a fully
Russian automatic and safe run of a selected sterilization
More on request program.
LOADING EQUIPMENT (optional) The liquid-crystalline alphanumeric display
sterilization basket 585x365x170 mm registers the changing data during the course of
sterilization basket 436x365x170 sterilization, as well as points to available options
inside cart and alerts to any failures.
inside cart whit two shelves Sterilization parameters are controlled by
transport trolley resistance temperature sensors and piezoelectric
pressure transducers.
All the automatic components in the sterilizers
come from famous manufacturers.
Monitoring and recording of a sterilization
program is done by control and measurement
monitors and by an alphanumeric printer.
The sterilizer’s housing is made of stainless steel
for easy maintenance.
OTHER STERILIZER ACCESSORIES & OPTIONS
o software for monitoring and archiving all
parameters of sterilization programs
o additional temperature sensor in chamber to
sterilize the liquids
o stainless steel piping – triclamp fittings
o HEPA filter (0,2 µm)
o compressed air support
o bio-barrier
STANDARDS AND CODES
The sterilizers meet the following provisions and
standards:
Europe:
EN 285:2006 +A2:2009 - Sterilization - Steam
sterilizers - Large sterilizers
EN ISO 17665-1:2006
Directives:
93/42/EEC Directive – Medical Device
97/23/EC Directive – Pressure Equipment
Safety and EMC Standards:
EN 61010-1:2010
EN 61010-2-040:2005
EN 61326-1:2013
EN 60204-1:2006, EN 60204-1:2006/A1:2009
Pressure Vessels and Steam Generator
Construction:
WUDT/UC/2003 – Pressure devices
STANDARD SAFETY FEATURES
Steam interlock door switch – Prevents steam
from
entering the chamber when the door is not sealed.
Steam safety valves – Ensure that the pressure in
the
chamber and/or jacket do not over-pressurize.
Door obstruction shut-off – On the top part of the
door is located security bar, which enable safety
close the door. In contact with security bar all
obstacles with a mass greater than 3 kg stops the
closing the door.
Analog chamber gauges – Needle-style gauges
provide real-time pressure readings in the jacket
and chamber even in the event of a micro-computer
control system outage
Thermal protection - In case of sterilizers with an
integral (built-in) steam generator an additional
protection against overheating has been mounted. A
temperature limiter, has been mounted on a boiler
bottom. The limiter turns off the heater power in
case when temperature on the surface of the boiler
significantly exceeds permissible operating
temperature.
Level sensor – steam generator is equipped with
two level sensors. The first is to keep the constant
level in the boiler. The second one is for disconnect
the power of heaters, when the water level drops
below an acceptable level.
WATER RING VACUUM PUMP
The vacuum pump effectively removes air from the
chamber. The pump is mounted on vibration
absorbers to minimize vibration.
During vacuum action the flow path of the media is
through the condenser (heat exchanger) and the
vacuum pump to drain. This protects the vacuum
system from excessive temperatures.
VALIDATIONS PORTS
The sterilizer chamber is equipped with two
measurement connectors. The connector for a
pressure measuring instrument: – pipe thread ISO
228-G½”A, and the connector for temperature
sensors – pipe thread ISO 228-G1” A.
AIR FILTER
Programs, the sterilizing cycle of which is completed
by a vacuum drying phase, require direct ambient
air supply to the sterilizing chamber. For this
purpose sterilizer is equipped with a filter (sterile air
filter) able to capture not less than 99,998% of
particles larger than 0,30 µm. Filter (hydrophobic)
for Bio-Hazard exhaust filtration is 0,20 microns.
STEAM SUPPLY
The autoclave is supplied with either a steam
generator or an option to connect to building steam
supply. A combined options of steam generator and
building steam supply is also available.
Steam Generator: supplies steam for the
sterilization process. The stainless steel steam
generator is an electrically heated type generator
equipped with immersion heaters, divided in three-
phases.
Water to the steam generator is supplied by a three-
phases pump, from a feed water reservoir, which is
connected to a source of mineral-free water.
STEAM GENERATOR WATER QUALITY
Various water systems can be used to supply
mineral-free water to the steam generator such as
Reverse Osmosis (RO), distilled water, etc. Water
supplied to the steam generator should be in
compliance with the EN 285 standard which
includes the following hardness and conductivity
requirements:
• Hardness<0.02 mmol/l
• Conductivity < 5 µS/cm
VACUUM SYSTEM AND DRAIN COOLING
WATER QUALITY
City tap water supply:
• Hardness between 0,7 and 2 mmol/l
• The tap water pressure should be in the
range of 1-6 bar
• Recommended temperature: 15°C
AUTOMATIC BLOW DOWN
Each time you turn on the sterilizer, if the pressure
in the steam generator is less than 10 kPa, is
removed from it water by programmed time.
TEPMPERATURE AND PRESSURE SENSORS
The temperature and pressure measuring circuits
are both linear and designed with components
having a high precision. The PT100 sensor conform
to Class A of the standard EN 60751
The control system allows for the calibration of
temperature and pressure to be performed digitally.
Each sensor circuit is calibrated with individual
constants to correct the deviation in manufacturing
and aging.
The system uses Flash memory in which the offset
and gain data of the sensors are stored.
• temperature and pressure in the chamber
at the intervals set in the printing interval
(Fig. 29);
• duration and end time of the cycle;
• minimum and maximum sterilization
temperature;
• process outcome (sterilization or a
tightness test) (positive/negative).
For backup / informational purposes, the same cycle
performance data is also automatically sent to a
USB flash drive port.
Graphical user interface
The operator interface of the steam sterilizer
comprises several screens. The current contents of
the display are referred to as the screen. There are
several screens that display different information:
temperature, pressure, text messages, icons
representing switching on/off of the device
components, buttons to navigate to other screens,
etc. The operator may move to a different screen by
pressing the appropriate button.
Main menu screen displays the device status
information (temperature, pressure, selected
program, current step of the program, etc.), and
the information about the start/stop of
the sterilization process. It can also be used to
navigate to other control screens.

CONTROL SYSTEM
The work of the sterilizer and its steam generator is
controlled by Siemens S7-200 controller.
All the activities such as the following: supplying
steam into the chamber, maintaining constant
temperature during the exposure phase, course of
the cycle, opening and closing the door etc.; and for
the version with the built-in steam generator:
automatic filling of the steam generator boiler with
water, inspection of heating elements to ensure a
constant steam pressure, are monitored on an
ongoing basis by the monitoring system. The
controller stores the following sterilization and test
programs: Bowie-Dick test and chamber Leak test. "Graph" screen displays the chamber pressure
and temperature as a graph. The graph allows
Cycle Performance Documentation the operator to monitor the process in real time.
The DGM AND series sterilizer provides two
standard means for cycle documentation:
• Paper printer
• USB flash memory drive
On the insertion side there is a printer that records
the sterilization cycle parameters.
• All the standard parameters of the cycle
are printed in a table.
• The printout includes the following data:
• temperature in the chamber;
• date and time of the cycle start;
• sterilization cycle number;
• operator number;
• serial number;
• set sterilization program parameters
(duration, temperature);
• name and start time of the process stage;
"Table" screen displays the course of operation of
the device. This menu displays the program settings
and the degree of its completion.
"Scheme" screen is used for visual supervision of
the control system. It allows the operator to monitor
the process (completion of the respective stages)
and the operation of the device components (valves,
pumps, level sensors).
"Manual control" screen is used for visual
supervision of the control system. It allows
the operator to monitor the process (completion of
the respective stages) and the operation of
the device components (valves, pumps, level
sensors).
The software of the sterilizer allows the operator to
carry out a number of operations in the manual
mode. This is particularly convenient in emergency
situations (i.e. when it is necessary open the door of
the pressurised chamber, etc.), as well as for testing
and servicing.
"Attention!" screen" displays the current system
messages. This screen appears regardless of
the screen viewed by the user. All messages
displayed in this screen are accompanied by a
sound signal.
FACTORY DEFAULT CYCLES
• Р01 Wrapped instruments 134°C
• Р02 Unwrapped instruments 134°C
• Р03 Wrapped instruments 121°C
• Р04 Unwrapped instruments 121°C
• P05 Prions
• P06 Vacuum Leak Test
• P07 Bowie & Dick Test
CYCLE PROGRESSION
• Venting
During that phase multiple pressure changes are
applied in a pre-programmed fashion. It causes
effective removing of the air from various forms of
load. Initial heating of load is performed.
Venting phase consists of four repeating cycles.
Every cycle starts when required pressure is
obtained, followed by pulsatory steam introduction
and then by full steam introduction.
• Heating
The purpose of this phase to heat load up to a
preset exposure temperature. This is accomplished
by filling the chamber with steam to the required
pressure. The pressure depends on a selected
temperature. The duration of this phase depends
mainly on the size of load put into a sterilization
chamber.
• Exposure
After equilibration of a temperature selected inside
load, countdown of the exposure time starts.
Condensates forming on load, chamber walls and
doors are removed from the chamber by a draining
installation. Temperature during all the exposure
phase should not be lower than a preset one and
should not be higher more than by 3°C. Duration of
this phase depends on a program selected.
• Decreasing
After the exposure phase is finished the pressure
inside the chamber is lowered to the level required
for a drying phase. Large pressure differential –
between the end of exposure and beginning of
drying – could cause in this phase damage to the
packs (paper-foil packaging) and therefore it is
extended in time.

• Drying
The purpose of a drying phase is to equilibrate the
temperature and humidity of the sterilized load. All
kinds of materials are exposed to high vacuum for
some time. After attaining the required pressure
level countdown of the drying time is commenced
automatically – depending on a selected program.
• Aeration
Aeration by means of a sterilizing filter is the
subsequent stage which completes the sterilization
cycle. The pressure is then brought from a negative
pressure to the atmospheric one.
ENVIRONMENTAL IMPACT
The sterilizer is composed of 94 % stainless steel, 4
% of non-ferrous metals and 2 % of other materials,
which – after dismantling the unit by an authorised
person – may be recycled.
DGM TOR System (optional)
System for monitoring and documenting processes
(track & tracing) of supplies movement and
processing.
• Automation of monitoring and documenting
the processes of infection control;
• Electronic document management;
• Automatic reporting;
• Flexibility in customizing for a particular
customer;
• Availability of process data transfer from
the installation to the PC;
• Broad opportunities for data-processing
(movement of supplies, as well as the staff
and documents).

MAINTENANCE / SERVICE PLAN CONTACT INFORMATION:

A global network of skilled service specialists can Baarerstrasse 8, 6th floor, Postfach 623
provide periodic inspections and adjustments to 6301 Zug, Switzerland
help assure low-cost peak performance. A detailed
service and maintenance plan is included in the Phone + 31 6 48 555 464,
user manual. Fax +41 41 766 77 01
e-mail: trade@dgmmachinery.com
www.dgmmachinery.com

PACKAGING FOR SHIPMENT

The sterilizer is packed in a wooden create for

shipping/transportation.

SPECIAL OPTIONS AND ACCESSORIES

Options

• Additional temperature sensor in chamber

for sterilizing liquids
• All pipes and fitting are made of stainless
steel AISI 316L
• Validation documentation IQ/OQ
• HEPA additional exhaust air filter
• Bio-seal
• Sterilization basket 580x280x260 mm
• Sterilization basket 535x380x195 mm
• Sterilization basket 535x380x100 mm
• Transport trolley
• Loading cart
• Water softener BWT
• Air compressor

Accessories

• Slot for connection with external PC for

monitoring process data
• Remote Reporting system