TECHNICAL SPECIFICATION

PlazMax Low Temperature Plasma Sterilizer

FEATURE SUMMARY DEVICE PICTURE

Chamber volume from 47 to 109 liters
Temperature range up to 50 C
No utilities needed except electricity
User friendly control system with touch screen display
Built-in printer
PC connection port for direct PC access
Aluminium chamber and door
Stainless steel piping
Conforms to standards: NP EN ISO 9001:2000, EN ISO
13485:2003, EN ISO 14937, EN 61010-2-040,
EN 61010-2-042, 73/23/EEC 89/336/EEC 98/37/EEC
93/42/EEC
Test kit (PCD) available

PRODUCT DESCRIPTION
This sterilizer series is designed to cover a large field of
applications for hospitals, CSSD, Gastro Clinics and medical
centers.

The sterilizer series has a chamber volume range from 47

liters to 109 liters.

The sterilizer operates with H2O2 as the sterilizing agent at a

temperature of 50 C.

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

PlazMax - Low Temperature Sterilizer

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.

Rev. 11-12-2012 Tuttnauer - Your Sterilization & Infection Control Partners Page 1 of 9
TECHNICAL SPECIFICATION
PlazMax Low Temperature Plasma Sterilizer

PRODUCT SPECIFICATION VOLTAGE SUPPLY

Three phase or one phase electricity supply is available.
CHAMBER VOLUME & SIZE
VOLTAGE
MODEL PHASES POWER (kW)
(V)
CHAMBER DIMENSIONS VOLUME
MODEL P50 220/230 V 1 2.9
(mm) (liter)
Width Height Depth P80 220/230 V 1 3.0
P110 220/230 V 1 5.0
P50 180 47
Frequency: 50 Hz or 60 Hz
P80 420 320 620 83

P110 420 109 LANGUAGE

The operator display is available in 5 languages including:
English, Portuguese, Italian, Germany, and French. Other
language selections are optional.
DOOR SELECTION
Single door
STANDARDS AND CODES
Double door (pass through)
Tuttnauer products meet the following provisions and
standards:
SERVICE ACCESS Standards
From unloading side. The PlazMax was developed in accordance with the below
norms and directives :
ISO 9001:2008 - Quality Management Systems
INSTALLATION SELECTIONS EN ISO 13485:2003 - Medical Devices - Quality
Cabinet enclosure [Single Door] Management Systems - Requirements for Regulatory
Cabinet enclosure through one wall [Double Door] Purposes
Installed through two walls [Double Door] EN ISO: 14971:2000 - Medical Devices: Application of risk
management to medical devices
ISO: 14937 - Sterilization of health care products -- General
ELECTRICAL COMPONENTS requirements for characterization of a sterilizing agent and
The following parts are located in the electric boxes: the development, validation and routine control of a
sterilization process for medical devices
The Solid State Relays for the command of the vacuum ISO 61010 - Safety requirements for electrical equipment for
pump. measurement, control and laboratory use)
The Circuit Breakers for protection of all power circuits. - Part 2-040: Particular requirements for sterilizers and
The power supplies for powering of electronic circuitry and washer-disinfectors used to treat medical materials
solenoid valves. - Part-042: Particular requirements for autoclaves and
An overload switch is used to protect the device from high sterilizers using toxic gas for the treatment of medical
overload currents. materials, and for laboratory processes

Directives
EU Directive 2006/95/EC Low Voltage Directive
EU Directive 2004/108/EC Electromagnetic Compatibility
93/42/EEC
CE Medical Device Mark 0344
EU Directive 2006/42/EC Machinery

Patent
The Low Temperature Sterilizer and its processes are
protected under Patent N. PCT/PT2007/000029

Rev. 11-12-2012 Page 2 of 9

TECHNICAL SPECIFICATION
PlazMax Low Temperature Plasma Sterilizer
CHAMBER CONSTRUCTION AIR FILTER
Materials A disposable microbiological air filter is provided to filter all air
The sterilizer chamber is constructed from solid, high quality entering the sterilizer chamber. The filter is rated for a particle
materials. Chamber and door thickness is no less than 6 mm. size of 0.2 m.

Standard Configuration Materials:

Chamber + Door: Aluminium CONTROL SYSTEM
The controls system is based on the Windows CE operating
system, and controls and monitors the physical parameters of
Chamber Design the sterilization process, and performs the operation sequence
A Teflon strainer protects the drain port from blockage by of the machine, according to the selected program, and
debris. The chamber is mounted on a steel framework. features:

Door Gasket Data acquisition from 10 inputs: four PT100 sensors, six 4-
Manual hinged door gasket: a silicone gasket is permanently 20mA analog inputs, and two 010V analog
fixed in the door. inputs
Digital inputs and outputs for sterilizer control
Chamber Heating Analog inputs from multiple temperature and pressure
The chamber is pre-heated by electric heaters to 50 C. Measures chamber pressure and temperature
Communication via an Ethernet 10/100 communication
Insulation port
The sterilizer and door are completely insulated with a 1" Analogue sensor calibration
chloride free glass wool thereby keeping the sterilizer cool on FLASH memory and real-time clock backup store cycle
the outside. data for at least 5 years even if there is a power failure

The control system controls all system functions, monitors

system operations, audibly alerts the operator of cycle
SAFETY FEATURES malfunctions.
Door Safety Systems
Chamber door cannot be opened when the cycle is active
H2O2 is not allowed into the chamber when the door is open TEMPERATURE AND PRESSURE SENSORS
The temperature and pressure measuring circuits are both
A cycle cannot start if the door is open or not properly
linear and designed with components having a high precision.
locked
The PT100 sensors conform to Class A of the IEC751
Double door safety is implemented through interlocks which standard.
prevent both doors from being opened simultaneously.
The control system allows for the calibration of temperature
Emergency Shut-Off: Easily accessible emergency switches and pressure to be performed digitally.
for immediate cycle shut-off.
Each sensor circuit is calibrated with individual constants to
correct the deviation in manufacturing and aging.
HIGH PERFORMANCE VACUUM PUMP
The vacuum pump effectively removes most of the air from the
chamber leaving a pressure of 0.1 mBar (almost absolute
vacuum). The pump is mounted on a damping mechanism to
minimize vibration.

PIPES & COMPONENTS

The piping system of the sterilizer consists of electrically
operated ball valves and dosing pumps, which control the flow
of H2O2 in and out of the chamber, operates the vacuum, and
the air inlet valve.

Standard configuration:
Piping and fittings: 316 tri-clamp stainless steel
Components: Stainless steel and brass

VALIDATION PORTS
The chamber is provided with one 1" tri-clamp connector for
optional vacuum/pressure gauges and test sensors. The
Validation Port is found on the left side of the sterilizer from the
control side.

Rev. 11-12-2012 Page 3 of 9

TECHNICAL SPECIFICATION
PlazMax Low Temperature Plasma Sterilizer
CONTROL PANEL
Control and Monitoring
The control system is operated via an easy to use full colour
touch screen (5.6 TFT LCD) found on the operator control side
(loading side), and on the unloading side for double door
models
The touch screen control panel supports 5 languages.
Thereafter, the sterilizer 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.
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.

LOADING EQUIPMENT
Two Pull Out Trays
Stainless steel trays equipped with tracks for easy loading and
unloading. The trays are made of durable AISI 304 stainless
steel.

STERILIZER DOCUMENTATION
A number of copies of the manuals are provided. Operator and
service manuals are in English. Manuals include electrical and
piping diagram.

Furthermore, the sterilizer is provided containing the following:

Operators manual
Technical manual
Serial number for specific sterilizer
Factory test report prior to shipping

Operators Control Panel (Touch Screen) STERILIZATION PROGRAMS

The sterilizer is supplied with 3 sterilization programs and 3
test programs. The cycle programs are summarized as
The following information is displayed: follows:
Sterilizer status: ready, exhaust, preparing for diffusion,
diffusion, aeration, cycle ended Note: For loads which its manufacturer declares to be in
Cycle name compliance with the following sterilization conditions using an
User messages H2O2 sterilizing agent.
Model Normal Cycle Advanced Endoscope
Cycle Cycle
ALARMS Non-hollow Hollow loads Two
The sterilizer uses both audible and screen messages. loads endoscopes
Automatic process checking and failure detection are provided Time (min.) Time (min.) Time (min.)
by the control system. In the event of a failure during and after P50 35 40 25
the diffusion phase the machine will aerate the chamber to P80 35 40 25
avoid residual H2O2, the system enters an alarm phase which P110 45 50 25
will safely end the process automatically. The range of alarms Note:
includes: Cycle time may change according to the load and the
condition of the sterilizer (hot/cold).
Temperature & pressure sensor failure Endoscope cycle temperature 40C (close to body
Phase time-outs temperature). Other cycles at 50C.
Door(s) not properly closed
Power failure
TEST CYCLE PROGRAMS
Program: Penetration Test
CYCLE DOCUMENTATION - PRINTER This program is intended to test the efficiency of air removal
The sterilizer is equipped with a printer which prints a detailed from the chamber.
history of each cycle performed by the instrument.
Test parameters:
The printing format is 24 characters per line. The following Sterilization temperature 50 C
information and set parameters are printed when the Cycle time 25min
sterilization cycle begins: Sterilizing agent H2O2

Sterilizer serial number, load no., name Program: "Air Leakage Test (Vacuum Test)
Software version This program is intended to test air leakage from the chamber
Real time through the door seal or any other seals. This test is
Selected program performed during the vacuum phase.
Sterilization temperature, pressure, and time
Alarms Program: Penetration + Air Leakage (Vacuum) Test
Penetration and leakage test cycles can be measured on a
shortened cycle saving time.

Rev. 11-12-2012 Page 4 of 9

TECHNICAL SPECIFICATION
PlazMax Low Temperature Plasma Sterilizer

MAINTENANCE / SERVICE PLAN

A global network of skilled service specialists can provide UTILITY DATA / REQUIREMENTS
periodic inspections and adjustments to help assure low-cost The user must ensure that all utilities used, including the
peak performance. A detailed service and maintenance plan is water, meet all the specifications mentioned in the
included in the operator manual. operator manual.

The user is subject to the full warranty statement found in the

documentation delivered with the equipment.
PACKAGING FOR SHIPMENT
Ventilation
The sterilizer is packed in a wooden crate for
10 air replacements per hour.
shipping/transportation.
Ambient Temperature
Plant room temperature should be in the range from 5
WARRANTY to 40 C and 85% RH (relative humidity).
Tuttnauer warrants that each device is carefully tested,
inspected and that it leaves the factory in proper working Floor
condition. The unit mass shall be considered no less than 10000 N/m2
according to the DIN 58949-7:2004 standard
Tuttnauer certifies that the device is guaranteed to be free from
defects in material and workmanship, for one year from Sterilizing Agent
installation date but not more than 18 months from shipping Number of cycles per machine from one bottle of sterilizing
date, against faulty components and assembly. Extended agent.
warranty periods are optional.

The warranty does not include and does not replace routine Model Sterilizing Agent Reference No. of Cycles
treatment and preventive maintenance to be performed
according to "Preventive and Periodical Maintenance" P50 AS040400 12
instructions mentioned in the device's accompanying manual. P80 AS080400 7
P110 AS100400 5

Note: Users must follow storage instructions for the sterilizing

agent.

Rev. 11-12-2012 Page 5 of 9

TECHNICAL SPECIFICATION
PlazMax Low Temperature Plasma Sterilizer

TECHNICAL DATA

P50 P50 P80 P80 P110 P110

MODELS
1D 2D 1D 2D 1D 2D

Doors 1 2 1 2 1 2

Useful Volume (Liter) 44 Lt 44 Lt 81 Lt 81 Lt 107 Lt 107 Lt

Total volume (Liter) 47 Lt 47 Lt 83 Lt 83 Lt 109 Lt 109 Lt

Tray Dimensions
W 400 400 400 400 400 400
(mm)

L 600 600 600 600 600 600

Chamber
W 420 420 420 420 420 420
Dimensions (mm)

H 180 180 320 320 420 420

D 620 620 620 620 620 620

Sterilizer
External W 700 700 700 700 700 700
Dimensions (mm)

H 1580 1580 1700 1700 1800 1800

D 640 640 640 640 640 640

Weight (Kg) 170 Kg 170 Kg 200 Kg 200 Kg 210 Kg 210 Kg

Power
Voltage (V) 230 V 230 V 230 V 230 V 230 V 230 V
Supply

Frequency (Hz) 50 Hz 50 Hz 50 Hz 50 Hz 50 Hz 50 Hz

Power (kW) 2,9 kW 2,9 kW 3 kW 3 kW 5 kW 5 kW

Rev. 11-12-2012 Page 6 of 9

TECHNICAL SPECIFICATION
PlazMax Low Temperature Plasma Sterilizer

PROGRAM CYCLE DATA (SCHEMATIC DIAGRAM)

NORMAL CYCLE
Preparation Preparation
for Diffusion for Diffusion

1000 mbar
Exhaustion Diffusion Plasma Diffusion Plasma Aeration
1 1 2 2

TEST CYCLE DATA

0
Vaporization

ADVANCED CYCLE

Preparation Preparation
for Diffusion for Diffusion

1000 mbar
Exhaustion Diffusion Plasma Diffusion Plasma Aeration
1 1 2 2

0
Vaporization Vaporization

ENDOSCOPE CYCLE
Preparation
for Diffusion
1000 mbar
Exhaustion Preparation Diffusion Plasma Diffusion Plasma Aeration
for Diffusion 1 1 2 2

TEST CYCLE DATA

TEST PROGRAM
0
CYCLE DATA
Vaporization Vaporization

Rev. 11-12-2012 Page 7 of 9

TECHNICAL SPECIFICATION
PlazMax Low Temperature Plasma Sterilizer

TEST PROGRAM CYCLE DATA (SCHEMATIC DIAGRAM)

LEAK TEST

1000 mbar Achieving Chamber is Sealed and

Deep Vacuum Monitored for Leakage

0
Passed
Leak Test

PENETRATION TEST
Preparation
for Diffusion

1000 mbar
Exhaustion Diffusion Plasma Aeration

0
Vaporization

PENETRATION & LEAK TEST CYCLE

1000 mbar Achieving Deep Chamber is Sealed and Preparation

Diffusion Plasma Aeration
Vacuum Monitored for Leakage for Diffusion

Passed
Leak Test

0
Vaporization

Rev. 11-12-2012 Page 8 of 9

TECHNICAL SPECIFICATION
PlazMax Low Temperature Plasma Sterilizer

CONTACT INFORMATION
International Sales and Marketing
E-mail: info@tuttnauer-hq.com
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: info@tuttnauer.nl

Tuttnauer - Your Sterilization & Infection Control Partners

Rev. 11-12-2012 Page 9 of 9