Low Temperature Steam and

Infection Control

Formaldehyde (LTSF) Sterilizer

MATACHANA 130LF®

COMMERCIAL DESCRIPTION – REF. 76330 – 76331

INTRODUCTION

Maximum efficiency with minimum % of formaldehyde

The new 130LF® belongs to the new generation of MATACHANA Low Temperature Steam and Formaldehyde
Sterilizers and continues the company tradition on Low Temperature Sterilization investigation and development.

It has been designed to complement the Steam Sterilizers in a RUMED (Reprocessing Unit for Medical Devices -
CSSD), Healthcare Centres as well as in surgical block and it is specially developed to sterilize heat sensitive
materials of high complexity as flexible gastrointestinal endoscopes, for example duodenoscopes.
Low Temperature sterilizer 130LF® offers a wide range of functional features and benefits, basic characteristics of
MATACHANA equipment. Its accelerated cycle time, proven triple safety and high penetrability power combined
with high quality construction materials and simplicity in use, guarantee the execution of efficient, safe and reliable
sterilization processes.

Being able to sterilize up to 12 kg starting from 58 minutes (78 °C program) and 90 minutes (60 °C program) with
only 2 % of formaldehyde, the new 130LF® is positioned on top of its category.
It is available in versions with one or two doors. The 2-door version ensures an effective barrier between the dirty
side and the clean side, optimizing the required hygiene levels and reducing the risk of hospital infections.

130LF® is designed and manufactured according to the European Standard EN 14180:2014 which establishes the
requirements and tests for Low Temperature Steam and Formaldehyde sterilizers. Sterilization processes performed
with the sterilizer can be monitored and comply with EN ISO 25424:2011, Low Temperature Steam and
Formaldehyde - "Requirements for development, validation and routine control of a sterilization process for medical
devices”.

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ABOUT LTSF TECHNOLOGY

30 years of history made short

MATACHANA LTSF sterilization was developed in the eighties and nineties of XX° century by MATACHANA
GERMANY (named “Webeco” in former times) and has been continuously improved and technically updated during
the last decades.

The scientific basics of LTSF have been established by numerous laboratory studies and publications of the German
Robert Koch Institute in Berlin (Germany), by practical test and performance evaluations at the Medical University
of Lübeck (Germany) and by valuable studies and publications performed in Sweden and Denmark.

LTSF was internationally standardized about 15 years ago by CEN (EN 14180) for LTSF sterilizers (design,
performance and testing), and by ISO/CEN for development, and validation of the LTSF process (EN ISO 25424).

MATACHANA GROUP has designed, manufactured and installed some thousand LTSF sterilizers mainly in Germany,
Austria and further European neighbouring countries, Latin America, China, Japan and SE-Asia, predominately
operating in hospitals.

Benefits of LTSF technology in a glance

▪ It is a low temperature sterilization process fully compliant with the general state-of-the-art and performances
of the established worldwide standardized sterilization processes.
▪ It can be operated on a high level of safety regarding sterilization performance, residuals on processed load,
occupational health requirements and environmental protection conditions,
▪ Its performance for routine operation has been established and verified in thousands of installations during
the past decades, operating with reasonable cycle times and costs.
▪ It grants an excellent sterilant penetration performance, particularly for narrow lumen and long hollow tubes,
limited only by the capacity of the chamber and load weight,
▪ it provides the maximum material compatibility compared to any other sterilization process, when processing
medical devices.

ACCELERATED STERILIZATION PROGRAMS – MAXIMUM SPEED

The New MATACHANA sterilizer 130LF® offers a speed increase of more than 80 %, which means a time reduction of
more than 40% compared to the previous model.
It features two differentiated sterilization programs to meet all needs in low temperature and beyond

60 °C program
Program to sterilize heat sensitive materials able to withstand up to 60 °C sterilization process.

▪ Type of load
It has been specially designed and developed to sterilize medical devices of high geometric complexity as
flexible gastrointestinal endoscopes, for example duodenoscopes. Multichannel rigid and flexible endoscopes,
complex cannulated instruments, optics and cameras can be sterilized.

▪ Total cycle time

From 89 to 110 minutes including desorption and drying. Cycle time depending on load, power supply and
water supply temperature.

▪ Maximum load
Up to 12 kg (including the weight of the baskets)

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▪ Cycle profile

78 °C program
Program to sterilize heat sensitive materials able to withstand up to 78 °C sterilization process.

▪ Type of load
It has been specially designed and developed to sterilize medical devices of high geometric complexity as
multichannel rigid endoscopes, complex cannulated instruments, optics and cameras.

▪ Total cycle time

From 58 to 90 minutes including desorption and drying. Cycle time depending on load, power supply and water
supply temperature.

▪ Maximum load
Up to 12 kg (including the weight of the baskets)

▪ Cycle profile

MAXIMUM PENETRABILITY

The New MATACHANA sterilizer 130LF® guarantees superior penetrability compared to other Low Temperature
Sterilization Technologies.
Its high penetrability power combined with no-limitation in number of lumens per cycle makes the sterilizer the
perfect solution for sterilization of complex flexible endoscopes.

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 VH202

VH202

LTSF has no limitations in number of devices or number of channels. Total load weight is the only limitation.

MAXIMUM SAFETY
The New MATACHANA sterilizer 130LF®, using only 2 % concentration of formaldehyde, guarantees triple safety: for
the patient, operator and environment.
All measurements have been carried out following the related European Standards, thus ensuring the most
restringing requirements.

Patient safety first.

The European Standard EN 14180 limits the average level of formaldehyde residuals on
processed medical devices to 200 µg and the maximum level to 400 µg.
The measurements obtained after the sterilization in 130LF®, and validated by external and
independent laboratories were:
- 145 µg (average) and 183 µg (maximum) with 60 °C program
- 83 µg (average) and 117 µg (maximum) with 78 °C program.

This means values between 28 % and 70 % below the limits.

Guaranteed user safety

The short-term exposure values measured and validated by expert laboratories
on safety in the working place were 0.04 ppm (0.051 mg/m3). The result
confirms that when operating the sterilizer 130LF® emissions are:

▪ 7 times lower than the European 8 hours exposure limit of 0.3 ppm
(0.37 mg/m3) and 14 times lower than the short-term exposure limit of
0.6 ppm (0.74 mg/m3) - in compliance with the DIRECTIVE (EU) 2019/983.
▪ 2 times lower than the lowest value in the application range of LTSF
sterilizers in the world, prescribed in Japan at 0.1 ppm (OEL).
▪ More than 18 times lower than the permissible exposure limit (PEL) declared by OSHA of 0.75 ppm (TWA).

Highest respect for the environment

The 0.2 g of formaldehyde per litre of water measured directly in the drainage of the
sterilizer are extremely low values, thus ensuring respect for the environment.

Limits may vary depending on local regulations.

Given figures for the results are governed from representative type tests on this model 130LF®. Results at user’s site
may differ due to not identical test conditions and procedures.

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 LTSF STERILIZING SOLUTION
The plastic bag containing the LTSF sterilizing solution is called e-bag® and it has been
specially developed to be used only in MATACHANA sterilizer model 130LF®.

LTSF Sterilizing solution is only 2 % concentration of formaldehyde aqueous solution

and it is provided in boxes of 3 e-bag® with volume of 2.7 l each.

Safe sterilization solution handling

The e-bag® is made of high impact resistant polyethylene (LDPE) and includes a RFID tag
to ensure the traceability of the LTSF sterilizing solution and greater control of expiration.

The Sterilizer will read the information in the RFID tag and will check the expiry date of
the sterilizing solution. In the case it is expired the sterilizer will not allow to perform any
cycle until a valid e-bag® is inserted.
The LTSF Sterilizing Solution traceability information: batch and shelf life may be verified
directly on the display.

The e-bag® compartment is located in the sterilizer’s front side compartment. The automatic perforating systems
enhances the safety and the comfort and the pilot light in the compartment makes more intuitive the replacement
step.
Once e-bag® is placed and perforated, its content is
automatically emptied in the corresponding container, without
any manipulation by the user. As soon the e-bag® content is
emptied, it can be removed without difficulties and a new
e-bag® may be introduced for future use.

The LTSF sterilizing solution has a shelf life of 36 months. This

ensures a greater inventory management flexibility.

EASE OF USE – EasyRUN user interface

Easy, intuitive and quick learning of the sterilizer operation thanks to the EasyRUN interface features.
▪ 130LF® features a high-quality 5.7” multi-touch colour screen which provides colour brilliance and an increased
viewing angle.
▪ The EasyRUN user interface, present in all MATACHANA devices, makes the 130LF® simple and quick during
user training and operation, allowing:
o Program selection, maintenance and statistics.
o Cycle progress including: remaining cycle time, cycle number, current phase
and relevant parameters.
o Doors operation and status.
o Management of alarms, warnings, operator errors, and reset cycle.
o Real time sterilization cycle chart (pressure and temperature).
o User management (creation and cancelation of names and passwords).
▪ Cycle completion success by color coding: green background display for cycles without faults and red
background display for cycles with faults.
▪ FRONTAL BACKLIT includes different icons visible from distance, allowing to know
the sterilizer status at any time. For example: process status, alarm and warnings,
service, etc.

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 DOCUMENTATION & CONNECTIVITY
▪ Printer
MATACHANA 130LF® sterilizers are equipped with digital thermal printer installed on the loading side
which includes a status led indicator, and prints detailed recording of the sterilization process. Besides
pressure, temperature and time, the printer provides other important data such as cycle number, batch,
date, total cycle time, etc. The printer paper roll enables to print up to 220 cycles and its superior quality
guarantees 12 years print out integrity.
▪ Internal memory
The large internal memory of the screen allows to store the data of the last 1000 process cycles (including
80 cycles with complete analogue curves).
▪ USB port
The sterilizer features a USB port located above the e-bag® compartment. All cycle reports will be saved in
the USB pen drive. The reports saved in html format can be opened in any browser and printed in any
printer.
▪ Ethernet port
Thanks to the Ethernet port the user can also print cycle reports in A4 format, using an external printer.
▪ Remote diagnosis
The sterilizer includes the remote connection which allows to the Technical Service to monitor the sterilizer
condition and prepare a diagnosis in case of failure.
▪ Connection to traceability software
130LF® is ready for connection to external systems (EasyLOOK, third-party traceability systems, etc.) as well
as to the internet through its Ethernet port.

ERGONOMICS
Its construction is practical and orderly. Main maintenance access of the equipment is carried out from the front
and left side.
▪ Ergonomic loading with extensible trays and automatic locking system.
▪ Ergonomic, safe and automatic sterilizing solution perforation system.

PREMIUM DESIGN – HIGH QUALITY MATERIALS & COMPONENTS

The MATACHANA sterilizer model 130LF® has been conceived using high-quality materials shaped with an appealing
minimalist and clean design. Everything to provide a long-lasting and stylish equipment to our clients and users.
It is equipped with the following constructive features:
▪ Front panel – upper part: Smart grey polycarbonate for protection and easy cleaning.
▪ Front panel – lower part: Made of resistant painted steel which avoids finger prints.
▪ Side panels: Made of AISI 304 quality stainless steel to provide robustness.
▪ Independent controllers: The sterilizer is controlled by two independent PLCs. One PLC-control integrated in
the touch screen located on the front panel, and second PLC-register integrated in the electrical panel. Double
controller ensures a full control of the sterilization process cycle after cycle.
▪ Chamber and doors: built in aluminium according to EN 485-2 Standard, for quick heat transfer, enhanced
energy saving and long-lasting equipment.
▪ Automatic door locking system: which prevents opening during the entire cycle. In the case of the two doors
sterilizer version both doors cannot be opened at the same time according to EN 14180. Unloading door can
only be opened if cycle has been completed successfully (without error).

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▪ Vacuum system: a powerful liquid ring vacuum pump is used in order to guarantee fast and effective removal
of condensates and deep vacuum levels which is required for the cycle operation.
▪ Vaporizer: designed to produce and supply steam to the chamber from the sterilizing solution during the
sterilization phase and from the demineralized water during the desorption steps. It is provided with an
automatic feeding system that avoids both supplies to get mixed.
▪ Validation port: the chamber features one specific inlet connection, to perform qualifications of the physical
parameters (equipment validation).
▪ Water purification through RO system and demineralization cartridge: the sterilizer is supplied with a
Reverse-Osmosis system and a DS cartridge. The combination of both systems provides a superior water
quality which is required during the desorption steps in order to remove any trace of formaldehyde prior to
the opening of the door.
This RO system is assembled prior to the DS cartridge. This significantly increases the life time of the DS-water
cartridge, which means fewer running costs and less maintenance.
▪ Pneumatic valves: are used in the main internal pneumatic circuit in order to ensure high reliability and
operation safety. Compressed air supply may be supplied by an external compressor or the option “built-in
compressor” may be quoted.

PROCESS MONITORING
As safety is first and foremost, the Chemical and biological Indicators have been carefully studied to be used as an
additional measure in assessing the effectiveness of the process. They comply with the international standards ISO
11140-1 and ISO 11138-1, -5.

MAINTENANCE
Its construction is practical and orderly. Main maintenance access of the equipment is carried out from the front
and left side.

AVAILABLE MODELS
Ref. no. Model Description
76330 130LF®-1 One door Low Temperature Steam Formaldehyde Sterilizer
76331 130LF®-2 Two doors Low Temperature Steam Formaldehyde Sterilizer

STANDARD CONFIGURATION
The 130LF® sterilizer is supplied with following parts:
▪ 1 lower and 1 upper shelves.
▪ 2 loading basket (W x H x D) 300 x 100 x 880 ref. 57056.3
▪ Build-in Thermal Printer.
▪ Reverse Osmosis System and DS water cartridge

OPTIONS
The 130LF® sterilizer has multiple options available to provide the user with the maximum flexibility to adapt its
functionality to their needs and to the facilities requirements:
▪ Side panels for 2-door version, ref. 78618.6
▪ Set of jambs and lintels, ref. 86500
▪ UPS, ref. 78830.1
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 ▪ Air Compressor, ref. 81901.4
▪ Voltage change, ref. 86600.7
▪ Frequency change to 60Hz, ref. 86600.5
▪ EasyLOOK supervision software, ref. 78450 + 78450.4
▪ Touch screen in unloading side, ref. 95602.4
▪ Kit Air supply to ejector - for high temperature vacuum water conditions. (ask for more info)
▪ Kit Air supply from compressor to ejector - for high temperature vacuum water conditions. (ask for more
info)

COMPLEMENTS
The 130LF® sterilizer has multiple complements to provide the user with the maximum flexibility to adapt the
equipment to the needs and to the facilities requirements:
▪ Manual transport trolley for 130LF® and 130HPO® ref. 78021.8
▪ Loading basket (W x H x D) 300 x 100 x 440 ref. 57056.2
▪ Loading basket (W x H x D) 300 x 100 x 880 ref. 57056.3 (C)
▪ Loading basket (W x H x D) 290 x 270 x 880 ref. 57058.9 (D)
▪ Upper loading shelves
(supplied with one-door version equipment), ref. 57056.5 (A)
▪ Lower loading shelves
(supplied with one-door version equipment), ref. 57056.4 (B)
▪ Upper loading shelves - (supplied with two-door version equipment), ref. 57055.5 (A)
▪ Lower loading shelves - (supplied with two-door version equipment), ref. 57055.4 (B)

DIRECTIVES AND STANDARDS COMPLIANCE

The 130LF® sterilizer whose intended use is the sterilization of invasive medical devices in the field of healthcare, is
classified as class IIb in the scope of Directive 93/42/EEC medical devices and is therefore regulated as medical
device. Additionally, it complies with the following standards:
▪ EN 14180
▪ EN ISO 25424

TECHNICAL SPECIFICATIONS
Technical specifications 130LF®-1 (one door) 130LF®-2 (two doors)
Overall dimensions (W x H x D) (mm) 900 x 1864 x 1101 900 x 1864 x 1118
Usable chamber dimensions (W x H x D) (mm) 335 x 363 x 929 335 x 363 x 972
Total chamber volume (litres) 143 148
Usable chamber volume (litres) 113 118
Max. load capacity (kg) 12
Touch screen dimensions (“) 5.7
Thermal printer Built-in thermal printer with status led indicator
V (3~, N, PE): 380 V to 480 V
Electrical supply
f : 50 Hz (other electrical supply options on request)
Power without options (kW) 8
Power with option compressor (kW) 8.5
Power with options compressor + ejector (kW) 9
Drain (mm) Ø50
Water supplies pressure (bar) 2.5 to 6
Water supplies connection G¾“
Net weight (kg) 550 600
Transportation environment conditions Temperature from 5 °C to 55 °C; 0 % ≤ Relative humidity ≤ 65 %
Storage environment conditions Temperature from 5 °C to 55 °C; 0 % ≤ Relative humidity ≤ 65 %
Operating environment conditions Temperature from 15 °C to 35 °C; 5 % ≤ Relative humidity ≤ 85 %

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