Tuttnauer - Intl - 44 and 55 - Medical - AB - Ver 1.5 PDF

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TECHNICAL SPECIFICATION

44 and 55 Compact Sterilizer Series

FEATURE SUMMARY DEVICE PICTURE


 Chamber volume from 120 to 310 liters
 Working pressure meets ASME and PED requirements
 Temperature range 105 °C (221 °F) to 137 °C (279 °F)
 18 kW integral electrical steam generator or external steam
source
 User friendly control system with to touch screen display on
both sides of autoclave
 18 preset programmable cycle programs & 2 test programs
 Built-in printer
 PC connection port for direct PC access
 Independent pressure gauges on front panel
 316L stainless steel chamber and door
 Chamber has a mirror-like finish
 Stainless steel piping
 Conforms to Medical Device Directive 93/42 EEC and
PED 97/23 EEC, FDA Clearance
 Conforms to standards: ASME, AAMI/ANSI-ST8, EN 285,
UL
 Company approved for 21 CFR 820, ISO 9001:2000 and
ISO 13485:2003 (Medical Devices)
 Optional configurations available

PRODUCT DESCRIPTION 44 Compact Series with Hinged Door

This autoclave series is designed to cover a large field of


applications for hospitals, CSSD and medical centers.

The autoclave series has a chamber volume range from 120


liters to 310 liters.

The autoclave operates with saturated steam as the sterilizing


agent with a temperature range from 105 °C (221°F) to 137 °C
(279 °F) and a working pressure that meets ASME and PED
requirements. The autoclave is equipped with an 18kW
integral electrical steam generator which supplies the
necessary steam for the sterilization process. The sterilizer
may also be steam fed from an external steam source.

APPLICATIONS
Central Sterilizing Supply Department (CSSD)
Operating Theater
Out Patient Clinic

Information furnished by Tuttnauer is believed to be accurate and reliable.


However, no responsibility is assumed by Tuttnauer for its use.

This specification is subject to change without notice. 44 Compact Series with Vertical Sliding Door

Rev. 01-12-2011 Tuttnauer - Your Sterilization & Infection Control Partners Page 1 of 10
TECHNICAL SPECIFICATION
44 and 55 Compact Sterilizer Series

PRODUCT SPECIFICATION VOLTAGE SUPPLY


Three phase or one phase electricity supply is available.
CHAMBER VOLUME & SIZE
Voltage:
VOLUME  415V 3 Phase with Neutral
MODEL CHAMBER DIMENSIONS (mm)  380V / 400V 3 Phase with Neutral
(liter)
Width Height Depth  230V 3 Phase with Neutral
 208V 3 Phase without Neutral
4472 730 120
 220V / 230V 1 Phase *
4480 408 408 845 140  110V / 115V 1 Phase **

4496 970 160 * Must have building steam supply


** Must have building steam supply and vacuum by ejector
5596 970 250
508 508 Frequency: 50 Hz or 60 Hz
55120 1210 310 Steam generator power is 18 kW.

Customized electrical specifications are available (additional


cost).
DOOR SELECTION
 Single door
 Double door (pass through) LANGUAGE
The operator display is available in 23 languages including:
 Manual right hinged English, Spanish, German, Dutch, Russian, Chinese, Arabic.
 Manual left hinged

 Automatic vertical sliding (door on left, control on right) STANDARDS AND CODES
 Automatic vertical sliding (door on right, control on left) Tuttnauer products meet the following provisions and
standards:
All automatic doors have a robust hydraulic mechanism for
operating doors. Europe:
EN 285 for Large Autoclaves
SERVICE ACCESS USA:
From loading side and left or right side. ST8 – Hospital Sterilizers

Directives & Guidelines:


INSTALLATION SELECTIONS Medical Device Directive – MDD 93/42 EEC
 Installed in a wall [Single Door] Pressure Equipment Directives – PED 97/23 EEC
 Cabinet enclosure [Single Door] Low Voltage Directive – 73/23 EEC
EMC Directive 89/336
 Cabinet enclosure through one wall [Double Door]
WEE & RoHS Directives – 2002/95, 96
 Installed through two walls [Double Door] FDA Clearance

Safety and EMC Standards:


ELECTRICAL COMPONENTS IEC/UL/EN 61010-1, IEC/UL/EN 61010-2-041
The following parts are located in the electric boxes: IEC/EN 61010-2-040
EN 61326
 The Solid State Relays for the command of the vacuum International Protection Level IPx4
pump, and the water pump.
 The Circuit Breakers for protection of all power circuits. Pressure Vessel and Steam Generator Construction
 The power supplies for powering of electronic circuitry and Standards:
solenoid valves. ASME Code, Section VIII, Division 1, unfired pressure vessels
 An overload switch is used to protect the device from high ASME Code, Section I, for boilers
overload currents.
 The connection elements (sockets, plugs, etc) and Good Practice Standards:
components have a degree of protection conforming to the ISO 17665 (replacing ISO 13683 and ISO 11134)
IP44 protection level and conform to the IEC60529 ST79 (replacing ST46 and ST42)
standard.
Quality System Standards:
ISO 9001:2000 (Quality Systems)
ISO 13485:2003 (Quality Systems for Medical Devices)
21 CFR 820

Rev. 01-12-2011 Page 2 of 10


TECHNICAL SPECIFICATION
44 and 55 Compact Sterilizer Series
CHAMBER CONSTRUCTION
Materials Safety Valves: Both chamber and jacket are equipped with
The sterilizer chamber is constructed from solid, high quality pressure relief safety valves. If the pressure exceeds the
materials. Chamber and door thickness is no less than 5 mm. allowed limit then the safety valves will discharge.

Standard Configuration Materials: Built-in Steam Generator Safety: A water level control
Chamber + Door: 316L stainless steel system maintains a constant water level that ensures safe
operation of the heaters. Furthermore, a sensor ensures that
Jacket: 304L stainless steel the heater does not operate without a minimum water intake.

Optional Materials (Stainless Steel): Emergency Shut-Off: Easily accessible emergency switches
Chamber + Door: 316Ti for immediate cycle shut-off.
Jacket: 316L or 316Ti
Double Independent Monitoring: The combined digital and
Chamber Design mechanical monitoring systems provide a cross-reference and
The chamber is fully jacketed. The chamber floor is slightly guarantee accurate results. The operator has two means of
monitoring temperature and pressure.
sloped towards an internal drain to facilitate drainage. A
stainless steel mesh strainer protects the drain port from
blockage by debris. The chamber is mounted on a steel
framework which is height adjustable. WATER RING VACUUM PUMP
The vacuum pump effectively removes more than 99% air from
Door Gasket the chamber. The pump is mounted on a damping mechanism
Manual hinged door gasket: a silicone gasket is permanently to minimize vibration.
fixed in the door.
During vacuum action the flow path of the fluids is through the
Automatic sliding door gasket: a silicone gasket is fixed in a condenser (heat exchanger) and the vacuum pump/ejector to
groove in the door frame and the gasket is sealed against the drain. This protects the vacuum system from excessive
door by means of steam pressure. temperatures.

Surface Treatment
A passivation layer is applied to the internal surface through an PIPES & COMPONENTS
electro-chemical treatment which results in a smooth and shiny The piping system of the autoclave consists of air-operated ball
stainless steel. The resultant surface is polished to less than valves, which control the condensate and steam flow in and out
0.8 µm which is highly protected against corrosion. The of the chamber, operates the vacuum, and the air inlet valve.
internal corners are rounded to aid cleaning.
Standard configuration:
Chamber Heating Piping and fittings: 304 threaded stainless steel
The fully jacketed chamber is pre-heated by steam in the Components*: Brass
jacket.
Optional configuration (stainless steel):
Insulation
The sterilizer jacket and door are completely insulated with a 1" Primary piping & fittings **: 316 + triclamp fittings
chloride free glass wool thereby keeping the autoclave cool on Primary components: 316 triclamps or 316 threaded
the outside. Customized thicker insulation is optional. The
insulation is completely enclosed within a stainless steel cover. * Components – Manual valve, non-return valve,
pressure regulator, pneumatic valves, steam trap, etc.
The insulation reduces the energy consumption by keeping the
heat inside the jacket and chamber. ** Primary piping system that connects to the chamber
up to and including the first valve.

SAFETY FEATURES
Door Safety Systems: PRESSURE GAUGES
The single door configuration has four pressure gauges
 A pneumatic safety component (pressure switch) is
that indicate the pressure in the chamber, jacket, door
installed in the autoclave which prevents opening of the
gasket, and the steam generator line.
doors until pressure in the chamber reaches room
pressure.
These pressure gauges are located on the autoclave's front
 Door chamber cannot be opened when chamber is panel (loading side).
pressurized.
 Steam is not allowed into the chamber when the door is The double door configuration has two additional pressure
open. gauges on the unloading side that indicate the pressure in
 A cycle cannot start if the door is open or not properly the chamber and the pressure in the gasket of the second
locked. door.
 The sliding door movement will stop immediately if an
object is detected in front of the closing door.
 Double door safety is implemented through interlocks which
prevent both doors from being opened simultaneously.

Rev. 01-12-2011 Page 3 of 10


TECHNICAL SPECIFICATION
44 and 55 Compact Sterilizer Series
VALIDATION PORTS CONTROL SYSTEM (ALLEN-BRADLEY)
The chamber is provided with two 1" threaded connections for The controls system is based on the Allen Bradley MicroLogix
optional vacuum/pressure gauges and test sensors. The 1100 PLC platform, and controls and monitors the physical
Validation Ports are each found on the right and left side of the parameters of the sterilization process, and performs the
sterilizer from the control side. operation sequence of the machine, according to the selected
program, and features:
AIR FILTER
A disposable microbiological air filter is provided to filter all air  Data acquisition from 10 digital inputs: four PT100 sensors,
entering the sterilizer chamber. The air is used to equalize the four 4-20mA analog inputs, and two 0–10V analog
chamber pressure to atmospheric pressure at the end of the inputs
sterilization cycle.  Digital inputs and outputs for sterilizer control
 Analog inputs from multiple temperature and pressure
The filter is rated for a particle size of 0.2 µm.  Measures chamber pressure, jacket pressure, steam
generator pressure, door gasket pressure, and reference
temperature
 Communication via a serial port or an Ethernet 10/100
STEAM SUPPLY communication port (on some configurations)
 Analogue sensor calibration
The autoclave is supplied with either a built-in steam generator
 Fo mode
or an option to connect to building steam supply. A combined
 Barcode reading
option of steam generator and building steam supply is also
 FLASH memory and real-time clock backup store cycle
available.
data for at least 5 years even if there is a power failure
Additional specialized steam supply configurations are listed in
The system includes an additional memory device which
the Special Options and Accessories section below.
contains: the updated software, offset and gains, and in the
Built-in Steam Generator: supplies steam for the sterilization case of software or control error will reload the software
automatically.
process. The stainless steel steam generator is an electrically
heated type generator equipped with immersion heaters, The control system controls all system functions, monitors
divided in three-phases. The power of the generator is 18 kW. system operations, both visually and audibly alerts the operator
The electrical system of the steam generator is located in a of cycle malfunctions and, on demand, provides visual
separate electric box. indication of the chamber temperature and pressure.
Water to the steam generator is supplied by a single-phase
pump, from a water reservoir, which is connected to a source TEMPERATURE AND PRESSURE SENSORS
of mineral-free water. The temperature and pressure measuring circuits are both
linear and designed with components having a high precision.
The PT100 sensors conform to Class A of the IEC751
STEAM GENERATOR WATER QUALITY standard.
Various water systems can be used to supply mineral-free
water to the steam generator such as Reverse Osmosis (RO), When the exhaust temperature increases above 40°C
distilled water, etc. Water supplied to the steam generator (measured by a PT100 sensor at the exhaust drain) then tap
should be in compliance with the EN 285 standard which water is mixed with the exhaust to drain.
includes the following hardness and conductivity requirements:
 Hardness < 0.1 mmol/l The control system allows for the calibration of temperature
 Conductivity < 50 µS/cm and pressure to be performed digitally.
 Maximum consumption: 12 liters per standard load Each sensor circuit is calibrated with individual constants to
cycle correct the deviation in manufacturing and aging.
Note: Soft water should not be used since its use may result in The system uses FLASH memory in which the offset and gain
corrosion of the steam generator and chamber. data of the sensors are stored. This data may be entered into
the system, through programming or through the autoclaves
touch screen control panel.
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
3 – 5 bar (40 - 72 psi)
 Recommended temperature: 15°C
 Consumption: 160 liters per cycle average

Rev. 01-12-2011 Page 4 of 10


TECHNICAL SPECIFICATION
44 and 55 Compact Sterilizer Series
CONTROL PANEL ALARMS
Control and Monitoring The autoclave uses both audible and visual alarm indicators.
Automatic process checking and failure detection are provided
The control system is operated via an easy to use full colour by the control system. In the event of a failure during the
touch screens (7” TFT LCD) found on both sides of the sterilization cycle, the system enters an alarm phase which will
autoclave. One or both touch screens may be upgraded to 10” safely end the process automatically. The range of alarms
display. includes:

The touch screen control panel supports 23 languages.  Temperature & pressure sensor failure
 Phase time-outs
Twelve password access levels (0-12) are provided to control  Door(s) not properly closed
access/operation of the machine preventing unauthorized  Power failure
access. These access levels are customizable. Access  No water in the water reservoir
control can be applied to the following functions operated from  Optional utility alarms: no water / no steam / no air
the control panel:
 running test cycles
 sensor calibration, service and maintenance CYCLE DOCUMENTATION - PRINTER
 cycle selection, cycle start, customizing cycle parameters The autoclave is equipped with a printer which prints a detailed
 18 preset sterilization programs and 2 preset test programs history of each cycle performed by the instrument. Various
 door control types of printers are listed in the Special Options and
 testing inputs and outputs Accessories section towards the end of this document.

With the standard factory configuration, calibration of the The printing format is 24 characters per line. The following
temperature circuits and calibration of the pressure circuits information and set parameters are printed when the
require an access code. sterilization cycle begins:

 Autoclave serial number, load no., name


 Software version
 Real time
 Selected program
 Sterilization temperature, pressure, and time
 Dry time
 Alarms

Thereafter, the autoclave starts performing the sequence of


operations of the cycle. The measured values of temperature
and pressure are printed at fixed time intervals, according to
various phases of the sterilization process: 4 minute time
interval for vacuum, 1 minute time interval for sterilization, and
the start and end time of the drying phase. All interval times
can be user defined. Furthermore, the customer may request
customized time intervals prior to order delivery.

The data is printed from the bottom up, beginning with the date
and ending with “O.K.” for a complete cycle or “FAIL” for an
aborted cycle.

Operators Control Panel (Touch Screen)


OPTIONAL LOADING EQUIPMENT
Two Pull Out Trays
The following information is displayed:
Stainless steel trays equipped with tracks for easy loading and
 Temperature, chamber pressure and jacket pressure
unloading. The tracks are designed to prevent the trays from
 Door status
rolling over.
 Sterilization time count down
 Autoclave status: standby, ready, pre-vacuum, heating, Loading Cart and Transfer Carriage
sterilization, exhaust, dry time, air inlet, cycle ended The loading cart rolls off the transfer carriage onto the chamber
 Display of inputs and outputs with other maintenance rails for easy handling of heavy loads.
functions
 View of alarms history and general history log (2000 The transfer carriage uses heavy duty revolving wheels
readings) (castors) to maximize mobility in limited space, and wheel
 door/s status brakes to prevent rolling. There is a lock to prevent the loading
 cycle graph display with zoom cart from sliding. The legs of the transfer carriage are
 cycle name, cycle parameters adjustable to match the height of the loading cart with the
 user messages tracks in the sterilizer chamber.

Both the loading cart and transfer carriage are made of durable
AISI 304 or AISI 316 stainless steel.

See Special Options and Accessories section for more options.

Rev. 01-12-2011 Page 5 of 10


TECHNICAL SPECIFICATION
44 and 55 Compact Sterilizer Series

STERILIZER DOCUMENTATION Program 8, 9, 10 with Slow 121:


A number of copies of the manuals are provided. Operator and Materials which require a slow pressure exhaust in open
service manuals are in selected language. Other manuals are or closed containers (not sealed).
in English. Manuals include electrical and piping diagram. For loads which its manufacturer declares to be in compliance
the following sterilization conditions:
Furthermore, a CD is provided containing the following:
 Sterilization temperature 121 ºC
 Operators manual
 Sterilization time 15 minutes (programs 8 and 9)
 Technical manual
 Sterilization time 30 minutes (program 10)
 Serial number for specific autoclave
 Slow exhaust
 XPCS software for calibration and software download
 Slow discharge of pressure
 Factory test report prior to shipping
 Optional - technical specifications for component, etc.
TEST CYCLES
Program 11: Bowie & Dick Test
STERILIZATION CYCLES This program is intended to test the efficiency of air removal
The autoclave is supplied with 10 preprogrammed sterilization from within the chamber.
cycles and 2 preprogrammed test cycles. An authorized user
can change the parameters of each cycle. The number and Test parameters:
type of vacuum pulses, the atmospheric pressure value, and  Sterilization temperature 134 ºC
the pressure profile are also programmable. There are 6  Sterilization time 3.5 minutes
selectable exhaust modes. The cycle programs are  Fast exhaust
summarized as follows:  Drying time of 2 minutes

Program 1 with Fast 121: Program 12: "Air Leakage Test” (Vacuum Test)
Unwrapped rigid (instruments), etc. This program is intended to test air leakage from the chamber
For loads which its manufacturer declares to be in compliance through the door seal or any other seals. This test is
the following sterilization conditions: performed during the vacuum phase.
 Sterilization temperature 121 ºC
 Sterilization time 15 minutes
 Fast exhaust
 Drying time 1 min MAINTENANCE / SERVICE PLAN
A global network of skilled service specialists can provide
periodic inspections and adjustments to help assure low-cost
Program 2 and 3 with Fast 134: peak performance. A detailed service and maintenance plan is
Unwrapped rigid (instruments), etc. included in the operator manual.
For loads which its manufacturer declares to be in compliance
the following sterilization conditions:

 Sterilization temperature 134 ºC PACKAGING FOR SHIPMENT


 Sterilization time 3 minutes The sterilizer is packed in a wooden crate for
 Fast exhaust shipping/transportation.
 Drying time 1 min

Program 4 and 5 with Dry 134: WARRANTY


Wrapped materials (instruments), porous load, etc. Tuttnauer warrants that each device is carefully tested,
For loads which its manufacturer declares to be in compliance inspected and that it leaves the factory in proper working
the following sterilization conditions: condition.

 Sterilization temperature 134 ºC Tuttnauer certifies that the device is guaranteed to be free from
 Sterilization time 7 minutes defects in material and workmanship, for one year from
 Fast exhaust installation date but not more than 18 months from shipping
 Drying time 15 min date, against faulty components and assembly. Extended
warranty periods are optional.

Program 6 with Dry 121: The warranty does not include and does not replace routine
Wrapped materials (instruments), porous load, etc. treatment and preventive maintenance to be performed
For loads which its manufacturer declares to be in compliance according to "Preventive and Periodical Maintenance"
the following sterilization conditions: instructions mentioned in the device's accompanying manual.

 Sterilization temperature 121 ºC The user must ensure that all utilities used, including the
 Sterilization time 15 minutes water, meet all the specifications mentioned in the
 Fast exhaust operator manual.
 Drying time 15 min
The user is subject to the full warranty statement found in the
documentation delivered with the equipment.

Rev. 01-12-2011 Page 6 of 10


TECHNICAL SPECIFICATION
44 and 55 Compact Sterilizer Series

UTILITY DATA / REQUIREMENTS


External Steam Source Mineral-Free Feed Water for Steam Generator
1. 97 – 100 % dry saturated steam 1. Water intended for the steam generator must have a water
2. Steam rate 25 kg/h quality in accordance with ISO 17665
3. Pressure 4 to 6 Bar 2. Install 1/2" pipe with a shut-off valve at its end
4. Final steam pipe to the autoclave at least pipe 3/4" (ND 20) 3. Regulations may require a Back-Flow protection device
5. Install a shut-off valve at end of steam pipe 4. Supply: 25 l/h

Electrical Tap Water


With generator (all models) 1. Intended for vacuum pump and cooling.
 3-Phase, 208 / 220 / 230 / 380 / 400 / 415 Volt, with or 2. Install 3/4" pipe with shut-off valve at its end.
without neutral, 18 kW 3. Supply pressure 2 - 5 bar at approximately 15°C
 For autoclave model 55120: 3-Phase, 208 / 220 / 230 / 380 temperature
/ 400 / 415 Volt, with or without neutral, 24 kW 4. Local regulations may require a Back-Flow protection
device
Without generator (all models) 5. Hardness (free of alkaline earth ions) should be between
Note: must have building steam supply 0.7 mmol/l and 2.0 mmol/l
 3-Phase, 208 / 220 / 230 / 380 / 400 / 415 Volt, 6. Supply: approximately 17 l/min
with or without neutral, not less than 10 A
 1-Phase, 110 / 115 / 220 / 230 Volt, with neutral, not less Compressed Air
than 10 A, vacuum by ejector 1. At least 3/8" hose to supply the compressed air
 1-Phase (only 4472 and 4480 Models), 220 / 230 Volt, 2. The compressed air supply line coming from the building
with neutral, not less than 10 A, vacuum by V6 vacuum must have a shut-off valve
pump 3. Pressure: 6 to 8 bar, free from liquid water, filtered to
Additional customizable electrical specifications are available. 25 µm, free from oil droplets greater than 2 µm

Drainage (Sewage) Ambient Temperature


1. At least 2" sewage pipe Plant room temperature should be in the range from 5 to 40 °C
2. The sewage shall be able to withstand continuous and 85% RH (relative humidity).
temperature of 80 °C and for short time periods at 100 °C
Floor
3. Each autoclave will have a separate sewage line connected 2
to a vertical vent pipe. Vertical pitch is 1000 mm. The unit mass shall be considered no less than 10000 N/m
according to the DIN 58949-7:2004 standard.
Note: Local national regulations may require that the drain be
tapped and vented, and not connected to other drains which Ventilation
may cause back pressure or obstruct flow. An air break may 10 air replacements per hour.
also be necessary.

OVERALL EXTERNAL DIMENSIONS


DOOR CONFIGURATION EXTERNAL DIMENSIONS (mm)
MODEL
Door Type No. of Doors Width Height Depth
1 1290
Hinged 850 1630
2 1260
4472
1 1020
Vertical Sliding 1150 1630
2 920
1 1370
Hinged 850 1630
2 1370
4480
1 1120
Vertical Sliding 1150 1630
2 1040
1 1530
Hinged 850 1630
2 1530
4496
1 1320
Vertical Sliding 1150 1630
2 1200
1 1480
Hinged 950 1680
2 1520
5596
1 1190
Vertical Sliding 1250 1680
2 1160
1 1720
Hinged 950 1680
2 1760
55120
1 1560
Vertical Sliding 1250 1680
2 1400
Note: Upon request Tuttnauer can provide special configuration so that the autoclave will fit through narrow
passage-ways / elevators during transportation in and out of buildings.

Rev. 01-12-2011 Page 7 of 10


TECHNICAL SPECIFICATION
44 and 55 Compact Sterilizer Series

PROGRAM CYCLE DATA


Program 1 with Fast 121 Unwrapped rigid (instruments), etc.
Par 1, 2 Parameters Units Range Factory Setting
1. Sterilization Temperature ºC 105 - 137 121
2. Sterilization Time min 1 - 99 15
3. Exhaust Mode 1-6 1 (fast)
4. Drying Time (Post-Vacuum) min 0 - 99 1
Par 3, 4
Atmospheric Notes:
Pressure Residual air is displaced by 4 vacuum pulses (down to 25 kPa) and 3 steam pulses up
to 160 kPa. When the pressure reaches atmospheric pressure, the vacuum pump is
activated until the pressure drops to 25kPa.
Program 2 and 3 with Fast 134 Unwrapped rigid (instruments), etc.
Parameters Units Range Factory Setting
Par 1, 2 1. Sterilization Temperature ºC 105 - 137 134
2. Sterilization Time min 1 - 99 3
3. Exhaust Mode 1-6 1 (fast)
4. Drying Time (Post-Vacuum) min 0 - 99 1
Par 3, 4 Notes:
Atmospheric Residual air is displaced by 4 vacuum pulses (down to 25 kPa) and 3 steam pulses up
Pressure to 160 kPa. When the pressure reaches atmospheric pressure the vacuum pump is
activated until the pressure drops to 25 kPa.
Program 4, 5 and 7 with Dry 134 Wrapped materials (instruments), porous load, etc.
Par 1, 2 Parameters Units Range Factory Setting
1. Sterilization Temperature ºC 105 - 137 134
2. Sterilization Time min 1 - 99 7
3. Exhaust Mode 1-6 1 (fast)
4. Drying Time (Post-Vacuum) min 0 - 99 15
5. Dryvac Time min 0 - 99 5
Atmospheric Par 3, 4, 5 Notes:
Pressure Residual air is displaced by 4 vacuum pulses (down to 25 kPa) and 3 steam pulses up
to 160 kPa. When the pressure reaches atmospheric pressure the vacuum pump is
activated until the pressure drops to 25 kPa.
Program 6 with Dry 121 Wrapped materials (instruments), porous load, etc.
Par 1, 2 Parameters Units Range Factory Setting
1. Sterilization Temperature ºC 105 - 137 121
2. Sterilization Time min 1 - 99 15
3. Exhaust Mode 1-6 1 (fast)
4. Drying Time (Post-Vacuum) min 0 - 99 15
5. Dryvac Time min 0 - 99 5
Atmospheric Par 3, 4, 5 Notes:
Pressure Residual air is displaced by 4 vacuum pulses (down to 25 kPa) and 3 steam pulses up
to 160 kPa. When the pressure reaches atmospheric pressure the vacuum pump is
activated until the pressure drops to 25 kPa.
Program 8, 9, 10 with Slow 121 Liquids: slow pressure exhaust for open or closed containers
Parameters Units Range Factory Setting
Par 1, 2
1. Sterilization Temperature ºC 105 - 137 121
2.a Sterilization Time (program 8 and 9) min 1 - 99 15
2.b Sterilization Time (program 10) min 1 - 99 30
Par 3
3. Exhaust Mode 1-6 4 (slow)
Notes:
Atmospheric Residual air is displaced by 1 vacuum pulse (down to 25 kPa). A slow exhaust is
Pressure used to discharge pressure from the chamber very slowly. Exhaust time is dependent
on load volume and configuration of containers. This program is not designed in
accordance with the EN285 and must not be used for routine sterilization of medical
devices.
Program 11 Bowie & Dick Test Efficiency test of air removal from within the chamber
Par 1, 2 Parameters Units Range Factory Setting
1. Sterilization Temperature ºC - 134
2. Sterilization Time min - 3.5
3. Exhaust Mode - 1 (fast)
4. Drying Time (Post-Vacuum) min - 2

Notes:
Par 3, 4 Residual air is displaced by 4 vacuum pulses (down to 25 kPa) and 3 steam pulses up
Atmospheric
to 160 kPa. Drying is performed during a "low-pressure" phase. When the pressure
Pressure
reaches atmospheric pressure the vacuum pump is activated until the pressure drops
to 25 kPa. Only the number and type of vacuum pulses can be modified.
Program 12 Air Leakage/Vacuum Test Air leakage test to chamber through door and other seals
Parameters Units Range Factory Setting
Atmospheric 1. Stabilizing Time min - 5
Pressure 2. Test Time min - 10
Par 1, 2

Notes:
Chamber vacuum is brought to 10 kPa. Thereafter all valves and motors are closed
for 5 minutes enabling pressure stabilization. The acceptable pressure change over
5 min 10 min the following 10 minutes is 1.3 kPa.

Rev. 01-12-2011 Page 8 of 10


TECHNICAL SPECIFICATION
44 and 55 Compact Sterilizer Series

SPECIAL OPTIONS AND ACCESSORIES


Back-Up Cycle History
ADVANCED CONTROL FEATURES Flash memory can store a daily produced file which includes a
10” TFT (LCD) Touch Screen log of every 20 seconds. The device contains viewer software
Upgrade from 7” to 10.4” touch screen. and installation instructions. It can store an immense amount
of cycle data.
Independent Cycle Documentation
 Panel printer Barcode Reader and Driver
 Two probes PT1000 and PT100 allow detection of The barcode reader allows identification and tracing of the
temperature data so that they can be printed out. material flow in the CSSD by reading the barcode on the
 HACCP function key container/basket. The data is transferred to the AB control
 Two digital inputs for starting, storing and terminating the system and linked to the sterilization cycle parameters and
cycle program batch. Software is included.
 Real Time clock
 RS232/RS485/TTl serial interfaces Two Color Printer
 9 to 40 VDC power inputs Printer -IDP3550 Serial dot impact, two colors black/red, high
speed printing 3.6 lines/sec, 7 X 9 matrix 40 columns, 76mm
Supervisory Control and Data Acquisition Software roll paper, paper auto loading.
(SCADA)
Complete supervisory control and data acquisition. Provides Graphic Printer - DPU 414
supervision control, data logger and remote control of up to The DPU-414 is a silent high-quality printer that prints
16 autoclaves. The software creates an electronic file (SNP) characters and high-density graphics. The DPU-414 prints a
accessible with suitable data software such as Microsoft detailed history of each cycle performed by the instrument.
access and SQL to show real time data. Possibility to produce The price includes the TAS (Datalogger).
reports monthly or per cycle. The price includes a standard
PC with Windows license and all the software install and
tested in the factory. ADVANCED OPERATION FEATURES
Multipurpose Valve
Two Color Printer Compressed air operated control valve drains the water/steam
Printer IDP3550 Serial dot impact, two colors black/red, high and releases pressure in order to open the chamber if a cycle
speed printing 3.6 lines/sec, 7 X 9 matrix 40 columns, 76mm failure occurs due to electric power failure.
roll paper, paper auto loading.
Dual Steam Source Valve
RS Logic500 (Software) To connect central steam supply and backup steam generator.
The software license provides access for troubleshooting and
PLC code modification. This item is aimed at an authorized Foot Pedal to Open Door
dealer technician of the dealer to allow timeout access. The foot pedal feature allows one to open the door by foot.

Graphic Printer - DPU 414 Automatic Restart and Shutdown


The DPU-414 is a silent high-quality printer that prints Feature enables a preprogrammed restart and/or complete
characters and high-density graphics. The DPU-414 prints a shutdown of utilities at cycle end or set time, closing all utility
detailed history of each cycle performed by the instrument. valves, returning chamber and jacket to ambient temperature.

Independent alphanumeric Recorder


The independent alphanumeric recorder provides a printout ADVANCED STEAM RELATED OPTIONS
(to the DPU30) of readings from the temperature sensor Automatic Blow Down
(PT100) and one pressure transducer sensor. The printed Automatic drainage can be accomplished through the use of a
information is processed by an additional independent PLC programmable timer.
(AB 1400). An automated supervisory system that performs a
crosscheck between sterilization parameters of the control Separate Connection to Jacket and Chamber
system and those indicated by the independent recorder Enables reaching sterilization at a faster rate and improved
according to the EN285 and EN554 requirements. temperature control when working with liquids, especially with
The automated supervisory system is connected to a printer 0
105 C and less. This feature is vital for clean steam systems.
and prints the following information: cycle parameter set
points, cycle parameter values, cycle stages, date
and time, sterilizer serial number, cycle number and name, ACCESSORIES
load number, cycle failure messages and cross checking Air Compressor
exceeding results.
For operating the pneumatic valves and automatic door/s
(must be ordered if there is no local source of compressed
Chart Recorder (Independent Microprocessor Control)
air).
A high-speed chart recorder, with independent microprocessor
control and power supply, is suitable for independent cycle Hotwell
documentation. This multi-range input recorder can record 12 The hotwell heats water to about 80-90ºC to remove non-
points at once from RTDs and DC voltage input signals, condensable gases prior to being pumped to the steam
producing analog trend records and print-outs. Simple generator or STS generator.
operation with an easy-to-view display allows one to key-in
various items of set data. The unit operates independently of
the autoclave (obligatory for meeting EN285). Bio Shield Frame

Rev. 01-12-2011 Page 9 of 10


TECHNICAL SPECIFICATION
44 and 55 Compact Sterilizer Series
The sterilizer is surrounded by a frame which serves as a
preparation for a cross-contamination seal made of Neoprene
sheet that is attached between the frame and the wall at site.

Water Recycling System


This system recycles water necessary for the heat exchanger
to cool down the steam exhaust from the chamber. The water
saving system recycles the water and reuses it. Tuttnauer's
water saving system saves more than 50% of the tap water
used.

CONTACT INFORMATION
International Sales and Marketing
E-mail: [email protected]
Website: www.tuttnauer.com

Tuttnauer Europe b.v.


Paardeweide 36, 4824 EH,
P.O.B. 7191, 4800 GD Breda
The Netherlands
Tel: +31 (0) 765 423 510 Fax: +31 (0) 765 423 540
E-mail: [email protected]

Tuttnauer - Your Sterilization & Infection Control Partners

Rev. 01-12-2011 Page 10 of 10

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