Infection Control

Low temperature sterilizer

Matachana 130LF
 Infection control

Our innovative method

The OH-group product of chemical reaction between formaldehyde + water has a
significant higher reactivity towards organic material in gaseous state >50 ºC. This
constitutes the high sterilizing and penetrability potential of steam process with low
temperature and formaldehyde (LTSF).

The inactivation of microbes cells occurs by coagulation of protein and methylation

of nucleic acids.

The steam state of LTSF facilitates the penetration of the formaldehyde and improves
its inactivation power.

International standards for LTSF

sterilization
• Design, performance & testing: EN 14180. Product standard containing
minimum requirements and test methods to ensure a safe and efficient LTSF
process. Harmonized with the Medical Device Directive.

• Operation & process validation: EN ISO 25424. Standard covering requirements

for development, validation and routine control of LTSF process.

• Safety requirements (for all types of sterilizers): EN 61010-1 & EN 61010-2-040,

regarding safety requirements for electrical equipment for measurement, control
and laboratory use, particular requirements for sterilizers and washer-disinfectors
used to treat medical materials.

Material compatibility

According to ISO 17644, the medical device LTSF Sterilization

temperature of
manufacturer must specify the requirements for a safe 60 ºC or 78 ºC
reprocessing of his products to guarantee that medical
devices can be processed safely and will continue to
Sterilant solution
meet its performance specification. containing
only 2 % of FA
Additionally, Matachana Group has evaluated out of
38 different types of polymers most commonly used Efficient, safe,
for medical instruments and other items. comprising an excellent
penetration ability
Matachana Group has reached compatibility
statements from several surgical instruments and Wide material
endoscopes manufacturers worldwide. compatibility

Great performance
on long lumens and
flexible endoscopes
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Low temperature sterilization

Matachana 130LF
Main features

• Compact design.
• Steam-formaldehyde gas mixture with low
2 % formaldehyde content.
• Fully automatic PLC-microprocessor
control.
• Colour touch panel and two channel line
recorder (temperature/pressure) at the
loading area.
• Integrated water demineralizer and
reverse osmosis treatment system.
• High performance two stages water ring
vacuum pump with integrated ejector.
• Serial interface (RS232 ports) to connect
our supervision software EasyLOOK® or
to other traceability softwares.
• Wheels to facilitate mobility.
• Alphanumerical printer to print all the
relevant process parameters, messages
and alarms (optional).
• Backlit frontal offering great visibility.
•  A
 utomatic supply and perforation system
for sterilizing solution bags.

130LF-1 130LF-2
Technical specifications
(1 door) (2 doors)
Overall dimensions (mm):
Height 1864 1864
Width 900 900
Depth 1156 1234

Chamber useful dimensions (mm):

Height 320 320
Width 320 320
Depth 900 900

Power (kW) 7 7

Volume (liters) 145 145

Installation requirements:
Electrical supply:
400V/3 ~/N/PE/50Hz (optionally 200, 208 or 230V/3/~/N/PE/50-60Hz)

Water supply for vacuum system:

Drinking water, conductivity < 1.000 µS/cm, pressure: 4 bar

Water supply for demineralization Cartridge:

DI-water or drinking water, 1-5 °F, pH 7-9, pressure: 4 bar

Drain:
Rust-resistant syphonic drain able to withstand a temperature of 70 °C

Compressed air: exempt of impurities and duly filtered, pressure: 5-7 bar
Installation drawings

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 Infection control

LTSF process developed in

MATACHANA sterilizer 130LF
LTSF process is a modified steam sterilization process that uses steam with the
addition of formaldehyde as a sterilant (active agent). The process is carried out
at subatmospheric pressure, with 2 different temperatures as per the selected
cycle.

These are the main steps of the cycle:

1. Air Removal and Absorption

Transport of the effective media. The sterilizing agent must reach all surface
areas of the medical device which shall be treated, in sufficient quantity. The
sterilizer executes different consecutive phases of formaldehyde steam injection
pulses (pressure increase) alterning with vacuum stages (air removal).

2. Sterilization – Holding time

Microbicidal interaction. The sterilizing agent must be available at defined
concentration for a minimum of time at specified physical conditions. During
this phase, the pressure in the sterilization chamber is kept at constant level via
barometric adjusted pressure-control and re-feeding. During the entire reaction
time of the media the sterilization chamber is automatically tested for tightness.
If the pressure in the chamber exceeds a specific value above the working
pressure (e. g. due to a leakage), a failure message is emitted.

3. Desorption
The sterilizing agent and eventually further chemical reaction components must
be fully removed from the medical devices by several vacuum pulses with steam.
To do so, the air from the sterilization chamber is alternately evacuated and pure
water steam is fed several times into the chamber. The program ends after a
vacuum-drying phase and an aeration phase.
Upon indication “Cycle End” the sterilizer may be opened and the sterilized
materials unloaded and used with patients without extra-aeration needed.

Pressure 60 ºC cycle profile

1013 mbar
(ambient)

215 mbar

53 mbar
(vacuum) Time
Start Holding time Drying and aeration
Air removal/absorption Desorption
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Low temperature sterilization

Matachana 130LF
Comparative chart between LTSF and Steam
Sterilization
Pressure (mbar)

3000
Steam (134 °C)

2000

LTSF (60 °C)

Atmospheric
pressure
1000

0
Time

The LTSF process has certain similarities with steam sterilization, both cycles have also a
similar profile but with the following relevant parameters differences regards to temperature,
pressure and time.

Programs and applications

Test program
Vacuum test: Program to test tightness of the sterilization chamber
Sterilization programs

60 ºC program: UNIVERSAL CYCLE 78 °C program:

30 minutes sterilization time 10 minutes sterilization time

• Flexible endoscopes of all types, without restriction • Rigid endoscopes and their
lumens, number of channels or diameters accessories
• Electrical Scalpels • Microsurgical instruments
• Ophtalmological instruments,
• PHACO emulsifiers including PHACO emulsifiers
• Epidural pressure catheters • ECG and electro cables
• Bipolar cables • Light guides cables
• RX transductors
• Sternum saws Most of the materials that are sterilized with
• Biopsy bottles 60 ºC program could be also sterilized at
• X ray cover 78 ºC. However, MATACHANA specially
• Ophtalaser boxes, recommends this cycle for these type of
• Ophtalaser gums items.
• Chondrotome Of course, 78  ºC program can be used
• Long and narrow lumens, etc. for non thermo-labile materials which
are normally sterilized by steam as their
In a general way, any material compatible with ethylene shelf life is extended by this sterilization
oxide sterilization is likewise compatible with the LTSF method.
process.

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 Infection control

Consumables
Matachana Group has developed a complete range of articles that
guarantee the repeatability of the results cycle after cycle and allow
a visual and clear perspective of the good performing of 130LF
sterilizer.

Control indicators

The MATACHANA LTSF chemical indicators are totally according to

EN ISO 11140-1 Standard. They have been designed to evaluate
different conditions or parameters:
EXTERNAL PROCESS CHEMICAL INDICATORS, CLASS 1

Cod. 85694.5 Cod. 85690.1

LTSF tapes, class 1 indicator: check the humidity LTSF adhesive spots, class 1 indicator: check
and external contact of the packaging material the humidity and external contact of the
with LTSF sterilizing agent. packaging material with LTSF sterilizing agent.

PCD CHEMICAL INDICATORS, MICROBICIDAL EFFICACY,

CLASS 2, for penetrability efficacy THANKS TO SELF-CONTAINED
of LTSF method BIOLOGICAL INDICATORS

Cod. 85431.5 Cod. 85458.9 (48h) Cod. 85458.0 (8h)

LTSF loadcheck device + chemical strips,
class 2 indicators, specially created to test the
excellent diffusion and penetration of LTSF
agent inside long lumens and small tubular
cavities, as for instance, endoscopes
Self-contained biological indicators: They have
been developed according to the specific part
for formaldehyde biological indicators, EN ISO
11138-1, 5. With a reading within 8 hours and
within 48 hours (according to code).

INTERNAL CHEMICAL
INDICATORS, CLASS 4,
MULTIVARIABLE, to demonstrate
surface sterilization for non complex
materials

Cod. 85690.2
LTSF chemical strips, class 4 indicators: for
sterilization verification on the outer surface of
the instruments.
Cod. 85699 - Biological incubator
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Low temperature sterilization

Matachana 130LF
Sterilizing solution and other accessories
STERILIZING SOLUTION:
Box with 3 bags of sterilizing solution, with a volume of 2.7 litres per unit. To be used only for the
Matachana sterilizer 130LF. The sterilizing solution is contained in plastic bags of highly resistant
LDPE*, totally recyclable.

Matachana sterilizing solution is supplied in a LDPE*

disposable bag of 2.7 litres capacity and only 2  %
formaldehyde concentration. Once the bag is
placed properly in the consumption components
compartment, its content is emptied automatically
into the corresponding container, without the user’s
additional handling.

*L
 ow Density Polyethylene; recyclable material with great Solution bag
resistance and flexibility properties.

Wrapping material compatibility with LTSF process

Compatible with the packaging traditionally used in CSSD for steam sterilizers:

• Paper-plastic bags and rolls (the most recommendable)

• Sterilization paper: crepe, non-woven paper, PEP, SMS, etc.

Compatible with metal containers, provided that they are fitted with a filter.
Compatible with plastic containers.

Automatic solution
supply system
As standard equipment, the sterilizer is provided
with an automatic device which ensures safe supply
of the sterilant solution from the bag to a storage
tank located inside the sterilizer, preventing any
leakage or spillage of solution to the ground or
towards the user.

By simply inserting the sterilizing solution bag in

the compartment on the front of the sterilizer, the
system automatically detects the position of the bag
and when properly placed, blocks the bag while
activating the puncture operation.

Additionally, a number of illuminated icons on the

backlit front of the sterilizer report on the status of
the sterilizing bag as well as its correct perforation.
This way, the user can quickly find out if the bag
has been correctly placed, and its content properly
poured into the inner tank, for future dosing during
the execution of a sterilization cycle.

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 Matachana Group
Innovation is the way forward
Since our foundation 50 years ago, our mission has been to provide the best service, bringing
our knowledge and field experience to our customers to facilitate their daily work, allowing
them to be efficient in the production whereas keeping rigorously the quality.
Our history has taken us from the beginnings in 1962 to the transformation in 2000 in Matachana
Group, with its subsidiaries in France, Germany, Argentina and Asia Pacific, as well as the
collaboration of direct distributors in over 100 countries.

In Matachana Group we are aware that Training and Service contribute decisively to achieve
customer satisfaction. For this reason, we have always invested in the development of these two
areas of activity, which enables a direct contact with customers and help us to develop together
a continuous improvement process.

Technical Assistance Service

All specifications herein are provided for information purposes only and may be modified without notice.

A service of engineers, highly skilled expert technicians and support staff, all committed to
ensure the proper equipment operation and condition.

Training Academy
Committed to the responsibility to obtain the optimum operation from our equipment, in
Matachana Group we invest in the training of future users.
In addition, we offer training courses regularly in 5 continents, forming customers and direct
distributors.

Environmentally friendly
The sterilizers are designed and manufactured using the latest technologies on the market to achieve
the best results in terms of energy savings and reduction in water consumption.
Our Production Center complies with the ISO 14001 Environmental Management System.

Quality
All our products are developed, manufactured and tested within a strict quality control acc. to the
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International Standard ISO 9001, as well as the International Standard EN ISO13485 for the sterilizers
CA_IC_130LF_14_00_01_en 0115

marked as medical device.

MATACHANA GROUP - HEADQUARTERS

Almogàvers, 174
E-08018 Barcelona - SPAIN
Tel: (+34) 933 008 504
Fax: (+34) 934 854 354
int@matachana.com

Spain · Germany · France · Argentina · Malaysia