OPERATING INSTRUCTIONS

LTSF STERILIZERS

Doc.: M_130LF_08_02_en
Date: 26/02/2013 Rev.: 08_02
COPYRIGHT

All the rights reserved. Antonio Matachana, S.A. claims the intellectual property of the content of this manual. No
part of it may be used or copied without the prior permission of its legal representative, including its translation,
reproduction or manipulating by using any means or through any support, whatsoever.
A non-authorized use of the information contained into this document, as well as any infringement of intellectual
or industrial property rights held by Antonio Matachana, S.A., will lead to facing the legally established
responsibilities.

CONTENT

Due to the constant evolution of our devices, the content of this documentation may be submitted to modification.
Due to this fact, we strongly recommend the user to refer to the chapter “modification and updating note” (see
General Index).

Some features and / or user’s instructions may vary according to each device. Hence the need to consult the
section entitled “Special features of your device” (see General Index).

© Antonio Matachana, S.A.

TABLE OF CONTENTS

1. PRELIMINARY NOTES 7
1.1 GENERAL 7

1.2 BASIC SAFETY INDICATIONS 7

2. DESCRIPTION OF THE STERILIZER 9

3. AREA OF APPLICATION 11

4. TECHNICAL DATA 13

4.1 AMBIENT CONDITIONS 13

4.2 TECHNICAL REQUIREMENTS 14

5. GENERAL REMARKS FOR THE USE OF THE 130 LF STERILIZER 15

6. SHORT OPERATION INSTRUCTION MATACHANA SERIES 130LF 17

7. EQUIPMENT OVERVIEW, TECHNICAL DESCRIPTION 19

7.1 FRONT VIEW (LOADING SIDE) 19

7.2 REAR VIEW (UNLOADING SIDE) 20

7.3 STRUCTURE OF THE UNIT 21
7.3.1 STERILIZATION CHAMBER 21
7.3.2 CHAMBER LOCK 21
7.3.3 PREHEATING OF THE STERILIZATION CHAMBER JACKET 21
7.3.4 WATER-RING VACUUM PUMP 21
7.3.5 GAS JET 21
7.3.6 EVAPORATOR FOR FORMALDEHYDE STERILIZING
SOLUTION AND FOR WATER 21
7.3.7 FEEDING OF FORMADEHYDE STERILIZING SOLUTION
AND OF WATER 21
7.3.8 STERILE FILTER FOR WATER FEEDING 22
7.3.9 RE-FEEDING 22
8. INSTALLATION, SUPPLY AND PREPARATION FOR START-UP 23

8.1 INSTALLATION AREA 23

8.2 ELECTRICAL SUPPLY 24

8.3 OPERATING WATER CONNECTION 24
8.4 OPERATING WATER DRAIN 24
8.5 FEED WATER SUPPLY 25
8.6 STERILIZING SOLUTION SUPPLY 25
8.7 OPERATING PERSONNEL 25
8.8 INITIAL START-UP 25
9. FUNCTIONAL DESCRIPTION 27

9.1 PRE-HEATING OF THE STERILIZATION CHAMBER 27

9.2 PROCESS OF THE FORMALDEHYDE STERILIZATION 27

9.3 VACUUM TEST 28

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10. INFORMATION ON LOW TEMPERATURE STEAM AND
FORMADEHYDE STERILIZATION 29
10.1 AREAS OF APPLICATION 29

10.2 PREMISES OF THE EFFECTIVENESS OF FORMALDEHYDE

STERILIZERS 29
10.3 PREPARATION OF THE MATERIALS TO BE STERILIZED 29
10.4 WRAPPING OF THE MATERIALS TO BE STERILIZED 29
10.5 LOADING THE STERILIZER WITH MATERIALS TO BE STERILIZED 30
10.6 POST TREATMENT OF THE MATERIAL STERILIZED WITH
FORMALDEHYDE 30
10.6.1 REMOVAL OF FORMALDEHYDE RESIDUES 30
10.7 HOW TO HANDLE FORMALDEHYDE 31
10.8 RISKS 31
10.9 STERILIZING SOLUTION FOR FORMALDEHYDE STERILIZATION 32
10.9.1 BAG FILLING SYSTEM FOR MATACHANA FORMALDEHYDE
STERILIZERS 32
10.9.2 DISPOSAL 32
10.10 STERILIZATION CONTROL / EFFECTIVENESS TEST 32
10.10.1 PROCESS PHYSICAL AND CHEMICAL VARIABLES MONITORING 33
10.10.2 CHEMICAL INDICATORS 33
10.10.3 BIOLOGICAL INDICATORS 34
10.10.4 MATACHANA INDICATORS 34
10.10.5 DISPOSAL OF EXPIRED INDICATORS 35
10.10.6 VALIDATION 36
11. OPERATING THE 130 LF 37

11.1 DISPLAY LOADING SIDE 37

11.2 DISPLAY UNLOADING SIDE (TWO-DOOR STERILIZER) 38

11.3 SWITCHING ON THE 130 LF 38
11.4 MAIN MENU 39
11.5 LOGIN 39
11.6 PROGRAM SELECTION 40
11.7 STERILIZATION PROGRAM 41
11.7.1 PROGRAM SEQUENCE 41
11.7.2 PROGRAM ABORTION 43
11.7.3 PROGRAM END 43
11.8 VACUUM TEST 44
11.8.1 PROGRAM RUN 44
11.8.2 TEST ABORTION 45
11.8.3 END OF PROGRAM 45
11.9 SUBSEQUENT PROGRAM WITH LOWER PROCESS TEMPERATURE 46
11.10 WARNINGS / FAILURES 46
11.11 INFORMATION 47
11.12 STATISTICS 48
11.13 MENU OVERVIEW OPERATION 49
11.14 PROCESS DOCUMENTATION 50
11.14.1 GRAPHIC RECORDER 50
11.14.2 CHARGE PRINTER (OPTIONAL) 50
11.14.3 PC - PROCESS DOCUMENTATION 50
11.14.4 CONNECTION TO A CHARGE DOCUMENTATION
SYSTEM (OPTION) 51
11.15 OPERATING THE BAG FILLING SYSTEM 52
11.16 OPERATING THE CHARGE PRINTER 53
11.16.1 REPLACEMENT OF THE PAPER ROLL 53
11.16.2 REPLACEMENT OF THE RIBBON 54

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12. MAINTENANCE, ADJUSTMENTS AND PARAMETER CHANGES 55
12.1 MAINTENANCE AND ADJUSTMENTS 55

12.2 MAINTENANCE MENU 55

12.2.1 ADJUSTING DATE AND TIME 57
12.3 CHANGING OF PARAMETERS 58
12.4 PASSWORD ASSIGNMENT 59
12.5 MENU OVERVIEW MAINTENANCE 60
12.6 SPECIAL FUNCTION “POWER SAVE FUNCTION” 61
13. FAILURES AND WARNINGS 63

13.1 MEANINGS AND RESULTS OF FAILURES/WARNINGS 63

13.2 LIST OF FAILURES 64

13.3 MESSAGES AND WARNING MESSAGES 67
13.4 DISTURBANCES OF THE OPERATIONAL READINESS 69
14. CARE, MAINTENANCE AND SCHEDULED WORK 71

14.1 GENERAL 71

14.2 SERVICE ATTENDANCE 71

14.3 MAINTENANCE 71
14.4 SCHEDULED MAINTENANCE PLAN 73
14.5 PUTTING OUT OF OPERATION IN CASE OF SHUTDOWN OR TRANSPORT 73
15. DISPOSAL 75

16. STANDARDS AND CE-CONFORMITY 77

17. GUARANTEE 79

18. SPARE PARTS AND ACCESSORIES 81

19. SWITCHPOINTS AND TOLERANCES 83

20. FORMALDEHYDE EXPOSITION SPECIFICATIONS 130 LF 87

21. CHARGE DOCUMENTATION 93

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1. PRELIMINARY NOTES

1.1 GENERAL

This instruction manual provides the basis for the training of the operator and gives information, which
is essential for the operation and functioning of this apparatus.

It is device oriented and contains the description, handles the assembly, starting procedure, cleaning
instructions, maintenance and maintenance roster; including operation, monitoring and repair, as well
as storage and transport.

This instruction manual contains important indications and advice, which demand particular attention.
These are marked "CAUTION", "ATTENTION" or "INDICATION".

CAUTION:
is used when work or operating procedures have to be adhered by strictly, in order to avoid
endangerment of personnel. This includes indications of special risks while handling the appliance.

ATTENTION!
refers to work- or operating procedures, which have to be followed precisely, in order to avoid damage
to, or destruction of the apparatus. This also applies to routine work, which is performed after
particular wear-and-tear or under unusual atmospheric influences or operating conditions.

IMPORTANT INDICATION:
addresses process related technical requirements, which demand particular attention from the
appliance user.

1.2 BASIC SAFETY INDICATIONS

This instruction manual provides information about a medical device which may cause danger by
electrical voltage or current, mechanical, thermal or, if applicable, chemical processes, respectively.
Physical injury or material and property damage may occur.

Therefore, following safety instructions are strongly recommended to be followed.

- The device shall be used only for its intended use as described by its designation and within this
manual.

- The user shall follow strongly the advice and recommendations of this manual. Inappropriate use of
the device may cause damage of the equipment or be harmful to the user.

- The installation and commissioning shall be performed only by personnel which is specially trained
and authorized by the manufacturer.

- Preparatory procedures prior to operation shall be performed only by the user/operator according to
this manual or by personnel specifically trained for this purpose.

- Be advised never to put the device into operation when it is damaged or seems to be damaged.

- Service and repair actions shall be done only by qualified trained persons considering

- these Operating Instructions

- all other applicable additional user instructions
- applicable national laws and safety regulations (safety / accident prevention)

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- Preventive maintenance schedule shall be ensured by the user. Maintenance and service actions
shall be performed only by the manufacturer or by its authorized representatives.

- Should the maintenance be performed by the user, this latter will be held responsible for the
observation of the safety measures.

- Please note additional specific information for the application of formaldehyde sterilizers given in part 5.

Following hazard symbols can be found in the Instruction Manual and as stickers on some places at
the device. They have the following meanings:

Attention!
Consider special indication in the Instruction Manual.

Caution!
Hot surfaces, danger of burns!

Danger Symbol on the sterilization solution container:

Caution (Warning) Symbol GHS 07 according to the EC Regulation 1272/2008 for
marking hazardous materials.
See further details on the sterilization solution container.

Danger Symbol on the sterilization solution container:

Danger Symbol GHS 08 according to the EC Regulation 1272/2008 for marking
hazardous materials.
See further details on the sterilization solution container.

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2. DESCRIPTION OF THE STERILIZER

Article Description: Formaldehyde Sterilizer

MATACHANA 130 LF
Code Number: 78026 130 LF-1

78029 130 LF-2

Produced, manufactured ANTONIO MATACHANA S.A.

and distributed by: C/Almogàvers, 174

E-08018 Barcelona
www.matachana.com

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3. AREA OF APPLICATION

The MATACHANA 130 LF is a Formaldehyde (FA) Sterilizer and is used for LTSF*-sterilization of
temperature sensitive materials at 60°C or 78°C.

The 130 LF is designed for stationary use.

INDICATION:
The Formaldehyde sterilization according to the LTSF* process is to be regarded as a supplementary
procedure to the traditional steam sterilization processes and is solely designed for sterilization of
temperature sensitive materials. It is not intended as a substitute or an alternative process to the
traditional steam sterilization procedure.

Thus, Formaldehyde sterilization is only reserved for those materials which can not be sterilized by
steam at 121°C and/or 134°C but can be treated with Formaldehyde at the a. m. temperatures and are
vacuum proof as well as moisture resistant.

(*) : LTSF: Low Temperature Steam and Formaldehyde

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4. TECHNICAL DATA

Installation and Connection Data

Dimensions (height x width x depth): 1875 x 700 x 1100 (mm)

Installation Base (width x depth): 700 x 1140 (mm)

Useable Space (height x width x depth): 320 x 320 x 900 (mm)

Weight: ca. 400 kg

Water Supplies: Hoses with threaded hose

1. Operating Water (7.1/18) coupling G3/4, flat sealing

for vacuum system : Raw water resp. drinking water

2. Water Supply

for demineralization Cartridge : DI-Water (de-ionized water) < 5µS/cm or drinking

water.

INDICATION: Appropriate water is reached when supplying raw water resp. to drinking water to the
built-in reverse osmosis device.

Drainage: floor drain (two-door sterilizer) or

wall drain (one-door sterilizer)
with stench trap connection hose DN 40
Electrical Supply: 400V/3~/N/PE/50Hz

(optionally 200, 208 or 230V/3~/PE/50/60Hz)

Total electrical Power: 7000 W

Protection Class according to IEC 536: Class I

4.1 AMBIENT CONDITIONS

OPERATION STORAGE AND

TRANSPORTATION
Temperature: 15 - 35°C 5 - 50°C
Pressure: 700 - 1100 mbar 600 - 1100 mbar

Air Humidity: 0 - 95% rel. humidity 0 - 65% rel. humidity

INDICATION:
Before using the device after storing/transportation at ambient temperature below 5°C (general) or
above 50°C and relative humidity above 65% it has to be slowly adapted to the current ambient
conditions for operation.

A temperature change rate >5°/hour at high humidity may lead to condensation and may cause a
temporary fault of the electronic components.

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4.2 TECHNICAL REQUIREMENTS
Sterilization Pressure

Maximum Working Pressure: -1,0 bar to 0 bar (gauge)

Operating Pressure: 10 - 200 / 440 hPa absolute

Maximum Working Temperature: 90°C

Operating Temperature : 60°C, 78°C

Total Volume of the

Sterilization Chamber: approx. 145 Litres

Heating System : electrical, via heater mats

Heating Power: 2670 W

Vaporizer

Construction: acc. to AD 2000 (coiled pipe)

Maximum
Working Pressure: -1/+3,0 bar relative

Maximum Operating Pressure: 1,5 bar overpressure

Maximum
Working Temperature: 150°C

Operating Temperature: ca. 125°C

Capacity of the Evapizer: 0,17 Litres (coiled pipe)

Feeding of Liquids for

Vaporization: on request via dosage pump

Heating Type: indirectly, electrically

Heating Power: 2000 W

Acoustic Power Level: medium value 60 dBA, peak value 70dBA

Heat emission to the environment: approx. 200 W to the area above the sterilizer (technical
/service area) approx. 75 W to the area in front of the sterilizer
(loading/ unloading side)
Remark:
Due to the specification given above and the evaporater being integral part of a medical device, it is
not subject to application of the Pressure Equipment Directive 97/23/EG.

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5. GENERAL REMARKS FOR THE USE OF THE 130 LF STERILIZER

Formaldehyde sterilizers must be operated in accordance with the operating instructions and treated
correctly in order to ensure proper operating procedure and necessary work safety.

Thus it is ensured that - in case of proper installation and operation of the MATACHANA LTSF 130 LF
1
- the emission of residual formaldehyde is permanently well below the MAK-value . Thus, monitoring
of the working area is then obsolete. National, country specific values must be taken into consideration

Only material with temperature sensitive parts that can not be sterilized with traditional processes e. g.
with steam at 121°C, may be sterilized in the Formaldehyde Sterilizer. Thus the Formaldehyde
Sterilization is a supplementary process to sterilization with steam.

Formaldehyde sterilizers must be operated in accordance with the operating instructions and
treated correctly in order to ensure proper operating procedure and necessary work safety.

When choosing medical devices for sterilization temperature and steam sensitivity, chemical stability
compared to the active agent, physical tolerance for over and underpressure and pressure changes
occurring during the process have to be taken into consideration.

Concerning this, the manufacturer of the medical devices has to inform in accordance with EN ISO
17664. If there are no information at hand, they are to be requested in case of doubt from supplier or
manufacturer of the medical devices.

The operating staff must be introduced to the operation of the sterilizer through personnel instruction
and by the user manual. The changeover in the operating responsibility must be accompanied by an
instruction. The responsibility for this is to be borne by the operator.

The user of the sterilizer has to create an operator's guide for the entire area of LTSF Sterilization, to
insure the technical follow up of the equipment, and including data such as inspections carried out,
times when the machine has been out of order, changes in the responsibilities, as well as
documentation on the sterilized loads.

Note (1) MAK-Value: Limit value for the maximum concentration for work stations according to the Deutsche
Forschungsgemeinschaft. Attention is also drawn to the TLV (Threshold Limit Values) established by
American Conference of Governmental Industrial Hygienists, and to local regulations on limiting
values for ambient concentration of chemical agents.

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 6. SHORT OPERATION INSTRUCTION MATACHANA SERIES 130LF

Antonio
Matachana
1 LTSF 130 LF
, S.A.,
asserts its
Rapid Operating Guide
right to be
Controls
identified
as the 1 Procedures
copyright
At the eginning of each working day.
owner of
this 1 Daily preventive maintenance
1 The following operations should be carried out on a daily
document.
basis. They may be performed by the sterilizer soperator.
It may not
be copied, ATTENTION! : Clean the door seal(s) in the loading area
reproduced and, in 2 door sterilizers, in the unloading area , with a damp
cloth. It is not necessary to remove the seals in order to
or given to
perform this operation.
any third
LOADING AREA PANEL UNLOADING AREA
party ATTENTION!: Clean the chamber with a damp cloth. Do not use
without the abrasive elements. WARNING !!! Make this operation with the
equipment disconnected and wait for the cooling of the chamber.
express
permission (N.S.A) PANEL (S.A) ATTENTION!: The sterilizer is provided with dismountable guides
of Antonio that can be removed to carry out the cleaning. Special attention
Loading area (N.S.A) Unloading area (S.A.) must be paid at the right front area of the chamber where the chamber
Matachana
Models 1 and 2 doors Models 2 doors probe is placed. Touching it must be avoided in order to prevent any
, S.A.
1.- Power switch 4.- Graphic Recorder possible damage to it.
2.- Printer(optional) 5.- Control panel S.A.
3.- Control panel N.S.A. 2 erify the installation supplies.

etail of the loading area door compartment 3 Turn on the power switch (1) and wait for the touch screen
to light up and the main menu to appear (this sequence takes about
1 2 40 seconds).
11 10
3 ARNING !!! Do not touch the screen during this time.
12
4 Check the graphic recorder and make sure there is enough
9 paper in the graphic recorder and or in the optional printer.

6 4 7 8
At the end of each working day.
5 Closing down
1.- Manometer Steam .- Water connection softened water
1 Turn off the power switch (1).

Generator Pressure .- Water connection operating water

Graphic Recorder
2.- Sterile filter for DI-Water .- Sterile filter for aeration
3.- Sterilization solution bag 10.- ag solution emptying device Check that it has enough paper and that the lines
4.- DI-water container 11.- uick coupling made by the pens are neat and clear.
5.- Sterilization solution storage 12.-Decalcification tablet lock There are red s in the right hand margin of the last 60
container cm. of paper to indicate that there is enough room left for
6.- DI-water cartridge
recording only 1 more sterilization process.
Graphic Recorder Digital printer (optional)

Printer optional
With regards to the digital printer (2) check that:

- The printer ribbon is in good condition. This can be done by looking at

the last program data record or by running a print test. old the printer
RESET button down and turn the power on via the power switch (1).

- There is enough paper.The 140 cm section of paper is marked

with a red line which runs from right to left as paper is fed into the printer.
IMPORTANT NOTE: Before starting the equipment, the user must consult the opeating instruction manual concerning the Date: 25-01-2013 Rev.: 06
application of the sterilization, control elements and safety feautres. Doc.: GR_130LF_06_00_en

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130lf_6_02_00_en
 Rapid LTSF 130 LF
2
Matachana
S.A.

Operating Guide
Antonio
Control Elements
Matach
ana Operating t e ma ine
S.A. Control panel Loading Area (N.S.A.)
asserts
its right
Sele ting t e re uired program
to be ?
identifie P A 1) Press the icon in the main menu of the start screen (A).
d as the 2) Press the icon for the program you want to run. A screen
copyrig
will appear (C) telling you that the program is being loaded.
ht
owner 3) The main cycle parameters and operating icons will
of this appear on the (C).
docume 4) Wait for the sterilizer is ready to start after the preheating
nt. It or re-cooling depending on the program selected.
may not
be
copiedp
roduce
Loading t e sterili er
d or ? 1) When the indication READY appears in the screen
given to P
any
the sterilizer can be loaded.
third 60 °C T 2) Open the door by pressing that unloc the door safety.
party °C B Then turn manually the door handle upwards.
without 3) Proceed to the loading of the sterilizer. See section 1 .5 loading
the
of the sterilizer in the Operating Manual.
presse
permiss 4) Close the door rotating the handle downwards. The door
ion of remains loc ed.
Antonio
E e uting t e program
1) Press I for a few seconds and the process will start.
2
2) The process proceeds in accordance with the relevant phases
0
60 °C Program described in section . in the operating instruction manual.
3) At the end of the program appears the indication
Ready
System ready to start Cycle completed and the acoustic signal is activated.
14 min. T 65,3 °C C

6 min.
P
Batch
99,9 kPa
12345
nloading t e material
FA 000 g ARN NG The material coming out the sterilizer is hot.
P
One. door sterili ers
60 °C Program 1) Once the acoustic signal is eliminated press to open
the door.
o doors sterili ers
1) Press the button placed under the door symbol in the
display (see D). This will unloc the door.
Cycle complete 2) Rotate the door handle upwards and open the door.
T 60,0 °C P99,9 kPa If the program has had a failure besides the corresponding
ENG ACK messages appearing in the screen an acoustic signal is activated.
F1 F2 F3 Press the button . This will deactivate the acoustic signal. (See section
11.11 of the operationg instruction manual to open the door in case of a
program failure).The desired cycles can later on be underta en in a
2 consecutive way or with intervals.
3)THE MATERIAL IS TO BE CONSIDERED UNSTERILE
IN ANY CASE
Program Abortion
60 °C Program How to abort the program if necessary:

Conditioning ac m still 5 pcs. 1) If it should be necessary during the program run to end the
Cycle r nning
program prematurely we must press for 15 seconds
12 min. T 65,3 °C continuously.
P 21, kPa Then the program will be interrupted and the recovery program
min. Batch 12345 will be operated. To open the door see section 11.11 of the
FA 1,23 g
P
operating instruction manual.
2)THE MATERIAL IS TO BE CONSIDERED UNSTERILE
IN ANY CASE.
Date: 5- 1- 1 Rev.:
Doc.: R 1 L en

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7. EQUIPMENT OVERVIEW, TECHNICAL DESCRIPTION

7.1 FRONT VIEW (LOADING SIDE)

11

12 1
2

4
13 5
14 6
7
15 8
16
9
17
10
18

Figure 7.1 : Front View of the Sterilizer

1 Main Switch / Emergency Off 11 Display (Loading Side)

2 Charge Printer (optional) 12 Line Recorder
3 Chamber Door 13 Sterilizing Solution Bag
4 Manometer Steam Generator Pressure 14 Decalcification Tablet Lock
5 Sterile filter for DI-water 15 DI-water Cartridge
6 Bag Emptying Device 16 DI-water Storage Container
7 Quick Coupling 17 Water Connection Feeding Water
8 Bag Support (labelled with "softened water connection)
9 Sterile filter for Aeration 18 Water Connection Operating Water
10 Sterilizing Solution Storage Container (labelled with " raw water connection")

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7.2 REAR VIEW (UNLOADING SIDE)

Figure 7.2 : Rear View of the Sterilizer

1 Display (Unloading Side)

2 Door chamber

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7.3 STRUCTURE OF THE UNIT

7.3.1 STERILIZATION CHAMBER

Made of Aluminium, AlMg3 in single wall design according to the technical regulations for pressure
vessels.

7.3.2 CHAMBER LOCK

Single sided hinged door provided with a shackle lock for tightening. Closing pressure applied through
a central pressure point and effects the movable hanged door blade.

7.3.3 PREHEATING OF THE STERILIZATION CHAMBER JACKET

Sterilization chamber and chamber door will be preheated via electrical heating mats. The heating
mats set is referred to in this manual as jacket.

7.3.4 WATER-RING VACUUM PUMP

A two stages water ring vacuum pump is used for generating the vacuum for the fractionned steps for
deaeration, humidification and conditioning of the materials to be sterilized as well as for removal of
the water steam, for drying and aeration of the sterilized materials. The pump is equipped with a
operation water circulating container and a system for controlled fresh dosage.

7.3.5 GAS JET

Automatically connected to the water ring vacuum pump is an ejector (third intensifier stage) for
improving the final vacuum.

7.3.6 EVAPORATOR FOR FORMALDEHYDE STERILIZING SOLUTION AND FOR WATER

The Formaldehyde Sterilizing Solution and Water Evaporator is designed as electrically heated
evaporator with automatic feeding device, independent pressure and temperature regulation as well as
pressure and temperature limitation.

7.3.7 FEEDING OF FORMALDEHYDE STERILIZING SOLUTION AND OF WATER

The sterilizer contains a 5 liter storage container with filling level control and an extracting system for
"Sterilizing Solution" (fig.7.1/6) and an approx. 2 liter storage container for "DI-water" (fig.7.1/16).

A stabilized solution of 2% formaldehyde is filled into the "Sterilizing Solution Container" (fig.7.1/10),
dosed according to demand and fed into the vaporizer which provides the formaldehyde containing
water steam for sterilization.

Please note that only the stabilized sterilizing solution for MATACHANA formaldehyde sterilizers in the
original MATACHANA safety refill bag may be used. (see in section 8.6)

For the Feeding Water Container (fig.7.1/16) only DI-water shall be used, which, after appropriate
dosing, is fed into the vaporizer, thus providing the required steam for the steam wash (desorption), to
remove the formaldehyde residues from the chamber and the sterilized material.

In order to avoid a germ growth in the storage container, it is heated.

Please note that only fully demineralized water shall be used, in order to avoid damage to the sterilizer
or the sterilized material.

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130lf_7_02_00_en
A reverse osmosis device upstream to the demineralizer cartridge prevents from very salted water
(e.g. due to an upstream soft water device). The water is pre-treated by the reverse osmosis device
and thus the lifetime of the demineralizer cartridge is clearly extended.

7.3.8 STERILE FILTER FOR WATER FEEDING

The demineralized water is fed as per demand from the storage container via a sterile filter (fig.7.1/5)
into the evaporator. With the help of the sterile filter possible microbial loads, which could be in the
feed water, are held back. The sterile filter is to be exchanged according to the maintenance
instructions in section 14.3.

7.3.9 RE-FEEDING

Automatic re-feeding of the boiler feed water into the storage container takes place, via the integrated
water treatment device.

For details on exchanging a depleted demineralizer cartridge see section 14.3.

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8. INSTALLATION, SUPPLY AND PREPARATION FOR START-UP

8.1 INSTALLATION AREA

The minimum size requirement of an installation room for a formaldehyde sterilizer should be 35m².
Generally a sixfold air-stream exchange per hour is recommended. In case of connection to an
existing air conditioning, it has to be ensured that the - possibly formaldehyde containing - room air,
cannot travel into any other rooms via this system.

The steam which contains formaldehyde, is sucked out by the water ring vacuum pump and
condensed in the pump’s operating water supply. The formaldehyde, strongly diluted with pump water,
is admitted to the waste water. Unavoidable charges due to waste air that contains formaldehyde are
kept on the lowest level in case of intended use.

According to model calculations for possible maximum formaldehyde charges in the working area of
the 130 LF sterilizer, confirmed by work area analysis according to TRGS 402 abd by TÜV Nord a
fresh air supply of at least 100m³/h has to be ensured in order to keep the maximum charge safely
under 0,1ppm. This applies if the 130 LF sterilizer is the only relevant source of formaldehyde
emission in the installation area.

According to the European Directive 89/391/CEE for improving Safety as work and Labor Protection,
as well as the European Directive 98/24/CE on health protection and safety measures for employees
against hazardous substances, adapted to the various legislation in force in each country from the
European Community, the employer is obligated to perform a risk analysis for the work place.
Regarding to room air charge not only the LTSF sterilizer but also other sources for formaldehyde
emission have to be considered, e. g. by disinfection within the area, or by operation of another 130 LF
sterilizer. This may result in additional requirements for ventilation in the installation area. Details
regarding formaldehyde exposition due to operation of this sterilizer are given in the annex III to this
Operating Instruction manual. They can be used for determination of possible further measurements
within the risk analysis.

Another suitable measure in case of additonal formaledhyde emissions in the work area and for further
minimization acc. to the Directives mentioned previously, is to discharge waste air from the vacuum
system through a pipe or hose (DN40) outdoors or to filter accordingly.

Normally LTSF sterilizers should not be installed in rooms where people are residing constantly. In
case of two-door sterilizers, this is valid for the side where the sterile material is unloaded. Excluded
from this requirement are work rooms in the area of sterile material supply.

INDICATION:
The MATACHANA LTSF sterilizer 130 LF must be operated according to this operation instruction,
and needs to comply with the applicable normative on prevention of risks at work. If the sterilizer is
properly operated, it is ensured that the formaldehyde concentration in the air is constantly kept on the
lowest level for all operations at the work place.

To satisfy First Aid concerns, a handwash basin is to be present in the installation room or in its
immediate vicinity, so that in the event of skin contact with a sterilizing solution containing
formaldehyde, the affected area can be rinsed off immediately.

ATTENTION
The sterilizer is not designed to be operated in areas that may be prone to explosions.

INDICATION:
It is highly recommended to hang out the Rapid Guide, as well as the Operating Instructions in
accordance with the assessment on occupational hazards of the post, within easy reach of the
equipment, inside of the operating room.

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8.2 ELECTRICAL SUPPLY
Standardly the sterilizer is equipped for connection to AC-supply.

Alternating Current: 400 V/3~/N/PE/50 Hz (optional 200, 208 or 230 V/3~/PE/50/60 Hz)

Fuse Protection: 3x20 A (3x25 A if Option 230 V)

Power : 7 kW
Supply Cable: 5x2,5 mm² (4x4 mm² if options for 200, 208 or 230 V)

8.3 OPERATING WATER CONNECTION

To operate the water ring vacuum pump, cold raw water (max. 25ºC, drinking water quality) is required.
For its supply, a G ¾ water supply with an easily accessible manual closing valve is needed.

To separate the sterilizer from the drink water supply, an open water inlet container according to EN
61770 is integrated in the sterilizer.

The water distribution is handled automatically and efficiently via a thermostatic regulating device.
Connection takes place via 7.1/18

The water supply 7.1/17 is needed for supplying the integrated demineralizer cartridge with water (with
upstream osmosis device).

Different water qualities can be delivered to water supply 7.1/17:

• fully demineralized water with a conductivity < 5 µS/cm (demineralizer cartridge (7.1/15) must be
inserted as housing only (without demineralizing resin)
• drinking water quality, conductivity < 1000 µS/cm, internal water treatment and monitoring via
demineralizer cartridge (7.1/15).
• drinking water quality, conductivity > 1000 µS/cm or soft water.

A reverse osmosis device, additionally to the demineralizer cartridge for internal water treatment is
supplied already installed and included with the sterilizer.

8.4 OPERATING WATER DRAIN

The water from the sterilizer is to flow into a floor or also, wall inlet for one door sterilizers. This pipe
must have a steady gradient and shall not contain water pockets. The maximum permissible height of
a wall inlet is 440 mm above the floor area where the sterilizer is installed.

If the locally available drainage system is not adequately ventilated to guarantee drainage without
back flow, an open inlet funnel has to be provided.

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8.5 FEED WATER SUPPLY

For the desorption of gas by the steam flushing, fully demineralized water is required. This is
automatically fed into the 2 litres receptacle for "DS feed water" by use of a demineralization cartridge
If this cartridge is depleted, a corresponding message is shown in the display (7.1/11). In this case a
new cartridge has to be inserted as described in part 14.3.

8.6 STERILIZING SOLUTION SUPPLY

For sterilization, a stabilized aqueous solution, containing formaldehyde is required. This solution is to
be poured into the sterilizer's 5 litres container for "Sterilizing Solution". The sterilizing solution is
supplied in specific plastic bags, which can be connected directly with the storage container via a filling
device (see section 10.9).

ATTENTION!

Only sterilizing solution of the original composition may be used in the original safety refill bags which
are marked CE0179. Otherwise, the effectiveness, and/or minimization of formaldehyde residues on
the sterilized load and/or the ambience of the workplace as well as the safe handling cannot be
guaranteed.

Special attention shall be paid to the fact that the bag filling system and the design of the specific CE-
marked safety bags/canisters are part of an integrated safety system. Being specifically designed for
the sterilizer they are also classified to be a device within the scope of the MDD 93/42/EEC. Therefore
they are included into the formal declaration of conformity

Based on this, it is not allowed to use filling devices or bags which are not CE-marked.

Producers or users of other sterilizing solution compositions are fully responsible for all ensuing
consequences, if and when they occur.

8.7 OPERATING PERSONNEL

Formaldehyde sterilizers may only be operated by specifically trained experts with certificates of
competency for sterilizations and formaldehyde in automatical and fully automatical disinfection or
sterilization devices.

Attention is drawn to personnel training and operating requirements that might be required by national
regulations.

8.8 INITIAL START-UP

Before initial start-up of the device a functional test procedure (details indicated at EN14180, B3) and a
validation of the process shall be performed, in order to confirm correct installation, operation and the
specified process result. This work can be performed by an authorized validation expert of the
manufacturer of the sterilizer. For this, please contact our customer service.

Upon restarting the sterilizer after longer operational breaks, it has to be checked whether all supply
media are available and connected properly (stop valves, main fuses etc.).

The switching on and off takes places via the main switch (7.1/1) in the device front as usually during
routine operation.

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9. FUNCTIONAL DESCRIPTION

Formaldehyde sterilization in the MATACHANA 130 LF takes place with underpressure at 60°C or
78°C, according to the fractionated vacuum process with formaldehyde containing water steam,
system MATACHANA.

9.1 PRE-HEATING OF THE STERILIZATION CHAMBER

After switching on the sterilizer, the sterilization chamber and the chamber door are preheated and an
automatically proceeding flushing of the evaporator takes place. After reaching the nominal pre-
heating temperature at 60°C, or 78°C, the readiness for operation is indicated in the display. If the
device is cold and not yet preheated the initial pre-heating for the 60°C program is approx. 14 minutes
and approx. 21 minutes for the 78°C program.

The control device of the sterilizer permits the selection of the following programs:

- 60°C program: sterilization program with fixed parameters

with 30 min holding time at 60°C.
-78°C program: sterilization program with fixed parameters

- VT vacuum test with 10 min holding time at 78°C.

program: test program for checking the tightness of the sterilization chamber and of the
joined components

INDICATION:
Loading of the chamber with sterilization material and starting of the program may only take place after
completion of preheating or re-cooling and selection of program.

9.2 PROCESS OF THE FORMALDEHYDE STERILIZATION

After operating the start key, the sterilizing chamber is evacuated. For several times alternating
formaldehyde steam injection phases (pressure increase) and vacuum phases (evacuation) follow up.
Before each change between pressure increase and evacuation, there is a pressure holding time.

After this, the current sterilization cycle follows. During the sterilization phase the pressure in the
sterilization chamber is kept at constant level via barometric adjusted pressure control and re-feeding.
During the sterilization phase (holding time) a saturated steam atmosphere with a formaldehyde
content of 2% is generated in the chamber.

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.

After the holding time, a gas desorption phase follows via steam washing. The sterilization chamber is
again alternately evacuated and fed with pure water steam for several times.

The program is ended after a vacuum-drying phase and an aeration phase.

Upon indication "Cycle complete" the sterilizer may be opened and the sterilized materials may be
unloaded.

If the sterilized materials have not been unloaded, every 30 minutes a new short degassing phase of
vacuum and aeration will be effected automatically. Thus it is made sure that the contamination of the
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room air is below the threshold limit even if the sterilizer is discharged at a later time.

The following illustration shows the cycle profile sequence described above.

End
Start

Holding Time Desorption Flushing Post-cycle flushing

Conditioning
Drying Aeration

9.3 VACUUM TEST

Besides the sterilization programs at 60°C, 78°C, a short vacuum test program may be selected to test
some basic device functions and the tightness of the system. We suggest this program to be run once
a week.

After pressing the start button the chamber and the vaporizer are evacuated down to < 53 mbar. Then
aeration up to a pressure of 280 mbar takes place followed by another evacuation down to < 53 mbar.
After expiration of an equilibrium time of 5 min the test of 10 min is running. During this test time the
chamber pressure is monitored. It shall not increase by more than 10 mbar. Otherwise a failure
message is shown (see section 20.2, Alarm 18).

ATTENTION:
Test programs are no sterilization programs! Possibly brought in sterilization material has to be
regarded unsterile after a test program!

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10. INFORMATION ON LOW TEMPERATURE STEAM
AND FORMALDEHYDE STERILIZATION

10.1 AREAS OF APPLICATION

The formaldehyde sterilization according to the LTSF process is to be regarded as a supplementary

method to the traditional steam sterilization procedures. It is only intended for sterilization of objects
comprising temperature sensitive materials. It is not a replacement nor an alternative to the traditional
sterilization procedures using steam.

The low temperature steam and formaldehyde sterilization is thus restricted to objects which can not
be sterilized in steam even at 121°C, and which can be treated with Formaldehyde at 60°C (max.
process temperature 64°C) and/or 78°C (max. process temperature 82°C), and which are vacuum
proof as well as moisture resistant.

10.2 PREMISES OF THE EFFECTIVENESS OF FORMALDEHYDE STERILIZERS

The process of formaldehyde sterilization acc. to the LTSF procedure is more complex and difficult to
handle than the steam sterilization. Materials which are to be sterilized acc. the LTSF procedure, must
therefore be precleaned with particular care, in order to reduce contamination with germs, pyrogenic
substances, albuminous and mineral loads to a minimum.

10.3 PREPARATION OF THE MATERIALS TO BE STERILIZED

Products that are intended for repeated use, have to thoroughly cleaned and disinfected immediately
after use. Please pay special attention to narrow gaps and hollow spaces. To remove residual
detergents and minerals from the rinsing water and to reduce the quantity of pyrogenic substances, a
final thorough rinsing with distilled water; water that is depleted of pyrogenic substances or accordingly
filtered fully demineralized water is to be carried out.

The MATACHANA product spectrum contains a water treatment system. Using this device high quality
pure water can be produced. Please contact our responsible representative for more information.

The objects to be sterilized must be well dried before wrapping them so that no droplets or residual
humidity remains on the sterilization material. Drying in an airing cupboard under high temperatures is
not recommended.

10.4 WRAPPING OF THE MATERIALS TO BE STERILIZED

For the sterilization process it is necessary to use a wrapping material which is suitably germ proof in
order to avoid re-contamination. Furthermore, the wrapping must meet the requirements of steam and
of moisture permeability for sterilization and desorption. To avoid large residuals of the effective
solution, such materials which particularly bind humidity and formaldehyde have to be avoided.

Well suited for this purpose is the transparent sterilizing wrapping according to EN 868-5, being a
compound wrapping in tube or bag form. Its front part consists of foil and the back is made of special
sterilization paper.

Wrappings of foil tubes and textiles are not suited for LTSF sterilization.

If plastic or metal containers are used (the latter - if at all - preferably of thin walled aluminium) they
shall be provided with perforations at the bottom and top. Sterilization containers from the area of
steam sterilization are not suited.

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A welded double packaging, especially of single objects, is possible. Here it has to be noted that in
each case only the paper sides and the foil surfaces make contact with each other, and that the paper
sides are freely accessible to the sterilizing medium.

To avoid a mix up with untreated goods we recommend the use of treatment indicators (see section
10.10), like self stick dots, strips or data labels as being offered by MATACHANA (see chapter 18)

INDICATION:
It has to be made sure that the wrapping of the sterilized material is intact when discharging the
sterilizer. Sterilized material with defective wrappings has to be regarded as not sterile.

10.5 LOADING THE STERILIZER WITH MATERIALS TO BE STERILIZED

The material to be sterilized may not have contact with the chamber walls and the chamber door. The
wire baskets of the sterilizer are to be used for receiving the material to be sterilized.

Loading the Baskets:

The material to be sterilized has to be loaded in the baskets loosely. It may not occupy more than 75%
of the baskets´ volume as maximum. The loading weight may not exceed 3,5 kg per basket (additional
load without own weight of the baskets 2,5 kg).

Individual packages are to be inserted so that no mutual screenings occur (paper sides must be freely
accessible for the sterilizing agent). Larger horizontal surfaces where condensate could accumulate
should also be avoided. If possible, transparent sterilizing packages are to be inserted on edge next to
each other so that in each case paper surfaces are contiguous to paper surfaces and foil surfaces to
foil surfaces, in order that the foil does not cover the permeable paper surface.

The individual packages are to be marked with the date and the time at which the sterilization was
performed or completed.

10.6 POST TREATMENT OF THE MATERIAL STERILIZED WITH FORMALDEHYDE

Type and extension of post-treatment of the material sterilized with formaldehyde depend on the
adsorbing and absorbing capacities (accumulation and reception) of the material for the sterilization
medium, and on the efficiency of the desorption (steam washing) process being integrated into the
sterilizing program.

Since neither the manufacturer of the sterilizer, nor the user of the sterilized material know for sure, of
which temperature sensitive material the objects to be sterilized are made, the manufacturers of the
objects are advised by recommendation of the corresponding Health Authorities to indicate necessary
after treatment measures for the purpose of removing residual gas. The sterilized material must be
stored in a ventilated room.

10.6.1 REMOVAL OF FORMALDEHYDE RESIDUES

The desorption (steam washing) in accordance with the fractionated vacuum method which follows the
formaldehyde sterilization is very effective for the removal of formaldehyde residues at nearly all
common materials.

Research on various materials have shown that the residues remaining on the sterilized material are
very small and nearly immeasurable. According to international criteria physiologically, this is safe,
since such amounts of formaldehyde are reduced to formic acid by the human body and then excreted
from it.

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Since the residues of formaldehyde are also absorbed by the room air, the storage in well ventilated
1
sterilization storage areas is possible without exceeding the MAK value of 0,5 ppm.
Before releasing the sterilized material into the sterile goods area, that means before discharging the
sterilizer, the efficacy of the process has to be verified according to the corresponding regulations and
guidelines for handling dangerous substances.

The sterilization manager must check the proof documentation from the sterilizer and ensure by using
a suitable verification process that the process has been performed properly and that the personnel is
not endangered by formaldehyde residues when unloading the sterilizer.

A suitable procedure is the control of the device intern documentation of the process relevant
parameters according to EN 14180:2003 (chronological progress of pressure, temperature, quantities
of sterilizing solution (see section 11.14).

Any material sterilized with formaldehyde can generally be used again after cooling down.

10.7 HOW TO HANDLE FORMALDEHYDE

The MATACHANA-sterilizer is supplied with a aqueous solution containing 2 % formaldehyde and a

low content of methanol or ethanol as stabilizer of the solution. Formaldehyde is a hazardous
substance and subjected to national regulations regarding chemical and hazardous substances. Due
to the low portions of formaldehyde the working solution has to be marked only as injurious to health
(in the future by using the symbol for “Attention”). It irritates skin an mucous membranes.

Properties of Formaldehyde:
FA is a colorless gas which is easily soluble in water.
It has a biting smell being noticeable starting at 0,05 ppm. Thus it alerts of its presence, and does so
long before any actual danger.

Currently there are no fixed limiting values for handling formaldehyde. The current suggestion of SCOEL
(Scientific Committee on Occupational Exposure Limits, advisory body of the European Parliament) for a
limiting value for Europe wide implementation is 0,2ppmm. The DFG (Deutsche Forschungsgemeinschaft;
2
German Research Community) suggests a MAK-value of 0,3ppm after current evaluation. Within the
range of those limiting values there is no risk of fetal damage to be feared.

The sterilizing solution has to be stored so that it is protected from exposure to sunlight, heating and
frost. It may not be accessible for unauthorized personnel. Please pay attention to the expiration date
which is given on the bags containing the sterilizing solution.

10.8 RISKS

Formally formaldehyde belongs to the “hazardous working materials” and is classified in K3 according
to the EC European Directive 67/548 AI, i. e. there is cause for concern regarding possible
cancerogenic effects. However, some indications from animal experiments are not enough to regard
formaldehyde as cancerogenic for humans too.

Note (1): MAK-Value: Limit value for the maximum concentration for work stations according to the Deutsche
Forschungsgemeinschaft. Attention is also drawn to the TLV (Threshold Limit Values) established by
American Conference of Governmental Industrial Hygienists, and to local regulations on limiting
values for ambient concentration of chemical agents.

Note (2): see note (1) in same chapter

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Due to the low concentration of 2 % formaldehyde in the sterilizing solutions as compared with
Formalin with 35 - 37 %, the possible risk is very low. Concentrations between 1-25% are considered
as “injurious”, earlier as “minor toxic”.

INDICATION:
In the operating room an operating instruction according to §20 of Ordinance on Hazardous
Substances (Gefahrstoffverordnung) is to be hanged out. A sample is attached in the annex of the
user's manual. It shows – among other things - risks and the relevant protective measures.

10.9 STERILIZING SOLUTION FOR FORMALDEHYDE STERILIZATION

With reference to the chemical and physiological toxicological characteristics of the MATACHANA
Formaldehyde Sterilizing Solution and the specifics of its use, we refer to the EC Data File on Safety.

10.9.1 BAG FILLING SYSTEM FOR MATACHANA FORMALDEHYDE STERILIZERS

The MATACHANA LTSF sterilizers are provided with a safety bag filling system (fig.7.1/6) as
standard. This allows the trouble free and sealed filling of the sterilization solution storage container
(fig.7.1/10), without any burden of formaldehyde or sterilization solution to the user or the room.

On an external work place the closing membrane in the head of the refill bag (Code 85430, 3x2,75
liters effective solution) can be punctured with the hollow needle of the bag emptying device. Then it
can be placed on the provided bag support (fig.7.1/8) and coupled.

For further details on handling see section 11.15.

10.9.2 DISPOSAL

Minor residuals of the formaldehyde solution may be drained plentiful diluted in the water drainage
system.

The complete emptied bags (polyethylen) may be sent back for waste management to the
manufacturer if they are delivered free of charge, or they might be disposed with the usual waste in
agreement with the local governmental disposal association.

Due to the low formaldehyde concentration the effective solution is not to be classified as dangerous
for the environment according to the EC European Directive 2008/98/EC.

10.10 STERILIZATION CONTROL / EFFECTIVENESS TEST

Operators of formaldehyde sterilizers are advised to periodically check the sterilizers as to sterilization
effectiveness, (see EN ISO 25424):

- daily, using batch control systems (e. g. integrated automatic registration and
documentation of the process parameters, chemical indicators in test devices)

and

- yearly,thermoelectrical reference measurements of the physical process parameters and

microbiological control by using and bio-indicators (see EN ISO 11138-5) during
a reevaluation (revalidation).

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10.10.1 PROCESS PHYSICAL AND CHEMICAL VARIABLES MONITORING

For LTSF-sterilization the parameters to be checked are temperature, pressure, sterilization time and
verification of conditions for saturated steam and thus the transport of the effective agent (FA)
(humidity on the material). The physical parameters pressure, temperature and time are usually
recorded by a recorder or a PC documentation system. At the 130 LF the quantity of FA that is fed into
the process is additionally detected by measurements, supervised and displayed for documentation.

For evaluating the transport of the effective agent (penetrating ability), chemical and or biological
indicators are used in the test device with every charge. For charge documentation test devices
according to EN867-5 (see illustration 10.1) are recommended.

10.10.2 CHEMICAL INDICATORS

Chemical indicators are easy to handle and to evaluate. If certain specified process parameters are
maintained, they react with colour change. They enable the user to examine the performance of the
sterilizer easily. Thus they are practically very important.

However, product approval may not only rely on chemical indicators, this is an additional measure to
parametric approval (pressure, temperature, their time progress, quantity of effective agent).

Generally speaking, chemical indicators comprise a paper or similar, on which is deposited a

substance or chemical agent that changes colour (turns) when certain conditions are met.

On the market there is a variety of chemical indicators, which according to the International Standard
EN ISO 11140 are classified into 6 groups or categories:

- Class 1: Process indicators. They are used in each individual load unit (packet or container) to
indicate they have been exposed to the sterilization process, and therefore to enable to distinguish
processed packs from unprocessed ones.

- Class 2: Specific indicators to perform tests, for instance, to be used inside the test device.

- Class 3: Indicators for one variable. Are able to detect whether during the sterilization process
conditions are reached in a single critical variable.

- Class 4: Indicators for multi-variables. Are designed to detect the reaching of the specified conditions
for at least two critical variables.

- Class 5: Indicators integrators. Are designed to react to all critical process sterilization variables (time,
temperature and saturated steam), in such a way that they are comparable to biological indicators.

- Class 6: Indicators emulators. They are designed to react to all critical variables of a given
sterilization process.

Requirements for these indicators are specified in EN ISO 11140. The application scope is defined by
its own manufacturer. Attention is drawn to the international standard ISO 15882 which provides
guidance for selection, use and interpretation of results of chemical indicators.

Chemical indicators should be used for several purposes. Use class 1 process indicators on the
external surface of packaging of the medical devices to identify or to distinguish that it has been
processed for sterilization. These process indicators do not give indications about the quality of the
sterilization process, but merely help to ensure that treated sterile material does not get mixed up with
untreated sterile material. They do not justify the assertion that the treated material is sterile.

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Process indicators are offered in the form of self-adhesive dots, strips, and registration labels. Some
wrapping materials include imprinted treatment indicators.

Use class 4, 5 or 6 inside the packaging, together with the devices inside the packaging to check that
sterilization values for the evaluated variables of the chemical indicator have been reach there, and
class 2 chemical indicators inserted into a suitable test device in order to simulate instruments and
devices which are the most difficult to sterilize due to their complex geometry.

For routine sterilization control and monitoring The chemical indicators for sterilization control,
specially the class 4, 5 or 6 and the class 2 chemical indicators according to the use described above
that have been subjected to the sterilization process can, or should be can be glued into the
“Operation Diary of the LTSF Sterilizer” as batch documentation together with physical/chemical
reports given by the recording devices available in the sterilizer or linked to it.

Chemical indicators should also be used for validation and yearly revalidation purposes, especially the
ones to be used together with suitable test device.

10.10.3 BIOLOGICAL INDICATORS

For controlling the performance of sterilization processes, the so called biological indicators can be
used for certain tasks. They can be used for routine monitoring and specially, for validation and yearly
revalidation purposes.

The used test microorganisms have a high specified resistance against the sterilizing media
(characterized by the D-value). We recommend to perform a microbiological test in connection with a
physical/chemical test and also using chemical indicators..

According to today’s knowledge physically yearly examination combined with a microbiological test
should be provided. The type of microbiological test depends on the configuration to be tested (s. a.
EN ISO 25424, annex B). When the biological indicators are sterilized, they have to be evaluated in a
microbiological test laboratory.

Also, when biological indicators are used for routine sterilization monitoring, the type that also contain
a growing medium for cultivation may be used. Then, the evaluation by a microbiological test
laboratory is not needed. When using such biological indicators, checking for compliance with relevant
standards has to be done. See ISO 11138-5. See also EN ISO 14161 for further information and
guidance for selection, use and interpretation of results of biological indicators.

10.10.4 MATACHANA INDICATORS

MATACHANA offers a range of chemical and biological indicators including the test devices suitable
for routine monitoring as well as for validation and yearly revalidation of the sterilizer and its
processes. The following table displays a typical routine monitoring plan for each sterilized batch.
Nevertheless, the routine control should be defined by the user according to its own protocols and/or
Quality Management System. See the corresponding list of consumables on chapter 18 where
suitable indicators and test sets are listed.

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 PHYSICAL AND CHEMICAL VARIABLES CONTROL

Charge sheet + records from graphic

recorder and from digital printer (if available) EACH CYCLE + traceability labels
(if used)

CHEMICAL INDICATORS

Process chemical indicators class 1 On the external surface of the wrapping of EACH PACK
Batch control:
Chemical indicator class 2 inserted into the ONE per CHARGE
test device
Chemical indicators class 4 ONE inside of EACH PACK
BIOLOGICAL INDICATORS

Selfcontained biological indicator

or
ONE per CHARGE biological indicator strip inserted into the
test
device

1
2

1. Indicator receptacle 6

2. O-ring-sealing
3. Chemical indicator strip
4. Gasproof strip
5. Open end
6. PTFE tube
Diameter =2mm, length =1500mm

Figure 10.1 - Test Device according to the Performance Requirements of EN 867-5

10.10.5 DISPOSAL OF EXPIRED INDICATORS

· Chemical indicators
Chemical indicators can be safely disposed of directly as domestic waste.

· Biological indicators
The test spores which are located on the indicator are not humane pathogen. Nevertheless
the biological indicators should be sterilized before they are disposed of as domestic waste.

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10.10.6 VALIDATION

Validation is a documented method for inserting, recording and interpreting results that are needed to
verify that a process complies continuously with the alleged specifications EN 15424 is applicable for
validating LTSF processes.

Validation of processes in terms of the Medical Device Directive (MDD) shall

a) create high safety for treatment (cleaning, disinfection, sterilization) of medical devices and

b) verify the efficacy of the processes as pre-condition for the quality assurance for treatment of
medical devices.
3
Process validation , e. g. of LTSF Sterilization, must be performed before starting the routine
operation. The validation must verify that a parametric release which is based on process data takes
place if a product in it's final wrapping is submitted to a LTSF sterilization. Specifically for the
MATACHANA LTSF sterilization process these parameters are pressure, temperature, time and a
suitable monitoring of the sterilizing agent (feeding and evaporating process). These values can be
measured, reliably reproduced and documented.

The validation consists of tests with reference loads (commissioning) in order to verify that the
sterilizer complies with the specifications given by the manufacturer and of tests on the sterilization
material - inserted by the user - incl. packing and load (performance Evaluation).Additionally proof of
sufficient desorption (see also EN 14180, Attachment D and E).

Process validation should be performed once a year. According to MDD and applicable national
regulations e. g. "Medizinproduktebetreiberverordnung" (MPBetreibV) it is required. The Robert Koch
Institute Berlin has published additional specifications and reasons in form of a recommendation.

The process of validation consists of the following steps:

¨ Clarification of the Pre-Conditions
¨ Generating and approval of the Validation Plan
¨ Installation Qualification, IQ
¨ Operational Qualification, OQ
¨ Performance Qualification, PQ
¨ Generating the Validation Report
¨ Revision and approval of validation

4
Validation must be performed by persons who can verify that they are qualified for such work or by a
test laboratory that is accredited/certified for such task. Generally this work can also be performed by
an authorized validation expert of the manufacturer of the sterilizer. For this, please contact our the
Technical Assistance Service of ANTONIO MATACHANA, S.A.

Note (3): The reference measuring point for checking compliance with the sterilization temperature band is lo-cated at
the chamber temperature sensor (sensor in the chamber, at the bottom near the loading door).

Note (4): MATACHANA T.A.S, Technical Assistance Service is certified by a notified body acc. to MDD
for performing validations acc. to EN ISO 17665-1, EN ISO 25424, EN ISO 15883 and EN ISO 11607.
Acc. to the requirements concerning certification, the validation experts do not depend on instructions of the
management in order to ensure their objectivity.

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11. OPERATING THE 130 LF

11.1 DISPLAY LOADING SIDE

On the display foils of the loading and unloading side (two-door sterilizer) there are three different
LED's. Their meaning is described below:

This LED shines green with each key actuation, it shines red in case there is a failure of the display
and it blinks red if the buffer battery of the display is discharged.

If this LED is shining, the communication between control and display is working correctly (normality).
If there is a failure of communication the LED is dark.

If this LED shines green, the display is in normal operation mode. If there is no connection to the PLC,
the LED blinks.

The following figure 11.1 shows the principle display layout at the loading side. The blue layout with
the individual functional elements is displayed below. The functionality and the individual menus are
explained in detail in the following chapters.
Identification: This icon
identifies the indicated page
of the display

Help: Using this key, the help

menu belonging to the current
display page is shown

Back to previous page:

This icon refers to the
previous display page. By
pressing this key you return
to the previous page.
Figure 11.1

Pressing the [ ] key shows the help menu belonging to the current display page (figure 11.2). On
this page information referring to the values given on the respective display page and operating
instruction concerning the different keys and their respective functions are given.

By pressing
the button the
next respective
help page is
displayed

Back to current
display page

Figure 11.2
37
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11.2 DISPLAY UNLOADING SIDE (TWO-DOOR STERILIZER)

The meanings of the LED's on the display foil on the unloading side are explained in section 11.1.

The following figure 11.3 shows the principle display-layout of the unloading side.

Door status unloading

Door status side
loading side Program phase
Selected or failures and
program messages
Chamber pressure in
Chamber kPa absolute
temperature in
°C Alarm confirmation
Key for un-
locking the door (acknowledge) and/
or muting of the
alarm
Function keys, that are not needed

during normal operation.

Solely for MATACHANA Technical
Service. F3 is used to change the
display language

Figure 11.3

Indication Door Status: Door closed :

Door open :

11.3 SWITCHING ON THE 130 LF

The 130 LF can be switched on and off using the main switch (7.1/1).
After the 130 LF has been switched on using the main switch the following start page appears for
some seconds on the screen of the display and operation unit (figure 11.4) after system booting.

Figure 11.4

38
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11.4 MAIN MENU

After the initialization display the main menu (figure 11.5) is shown.

Program
selection
Information

Statistics
Maintenance

Login ( if function
"User Code Entry"
is activated)

Indication door
status loading Open door Indication door status
side (loading) unloading side

Figure 11.5

11.5 LOGIN

The Login Display page is only shown if the function of user code entry is activated in the
MATACHANA configuration menu. It is not normally activated. In case of being activated, and prior to
selecting a program or access another function, an entry code must be introduced. By pressing a key
that does only function after a code has been entered, you automatically get access to the Login
Display page (figure 11.6).

If the login should be performed at a later time or if the user code shall be changed, press [ ] on
the main menu to access the login menu.

Figure 11.6

To access the input display (figure 11.7), touch the blue digits (after operator). With the help of this
display the user code can be entered. So as the code is accepted, it must have been previously
registered into the system on the corresponding display (see figure 12.9).

39
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currently
loggend on
user

User code
entered via
this page

Escape

Return
Figure 11.7

The user code is entered by touching the digits shown on the display keypad. It can also be entered
or modified by using the cursor keys [ ] and [ ] to jump horizontally through the character
areas and by using the keys [ ] and [ ] to change the value of the respective character
area.
Press [ ] to confirm. To cancel the entry press [ ].

After confirming you get back to the login menu (figure 11.6). The entered code is now displayed on the
screen. Then, the key ] must be pressed to confirm the login. An access level appears on
[ display. By pressing [ the ] you get back to the main menu previous page.

If a user code that shall not be changed is already entered, you can leave the login menu by pressing
[ ].

11.6 PROGRAM SELECTION

By pressing the touch surfaces in the main menu (figure 11.5) the respective submenus can be selected.
To get into the program selection menu for selection of a sterilization / disinfection program or
vacuum test program press [ ]. The Program selection menu (figure 11.8) appears.

Vacuum test

Sterilization program program 60°C

Sterilization
program 78°C

Back to
main menu

Figure 11.8

In the program selection menu (figure 11.8) the available sterilization programs are shown. By using
the respective button the respective program is called and the program data are loaded. Then you get
to the first program sequence display page (figure 11.9). From this page the program can be started.
40
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11.7 STERILIZATION PROGRAM

11.7.1 PROGRAM SEQUENCE

With the program selection (program selection menu, figure 11.8) you get to the program sequence
display page. Here the program can be started. At first the program sequence page is shown (figure
11.9). Here different process parameters, such as temperature, pressure, time etc. are shown
numerically. Furthermore it is possible to close and/or open the door on the loading while the program
is not started, to change to the second program sequence page and to start the program.

Change to second program To help menu

sequence page
Selected program

Chamber

Program phase temperature in °C

Chamber
Estimated time until pressure in
kPa
end of charge
Expired time since Charge Number
Fed amount of
begin of charge
formaldehyde
during program
run
Door status
Back to program selection
loading side Open door Door status Program
menu
unloading side start

Figure 11.9

To unlock the door on the loading side press [ ].

Now the door can be opened by turning the door handle anticlockwise upward.
If the door on the loading side is open, following indication is shown on the display:

Only after selection of a program and pre-heating or cooling down of the chamber, the chamber
may be loaded and the program may be started.

After loading of the sterilizer the door is closed again. Locking takes place automatically. Then the program
is started by pressing the key program-start [ ] for several seconds. Directly after switching on of the
sterilizer a program start is not possible, because the chamber must be preheated to nominal temperature
first. If the preheating is completed this is indicated by the message "System ready to start".

After the program has been started you can not leave the program sequence pages 1 and 2 (figure
11.10 and 11.11) until the program has ended.

After the program start the current program phase, elapsed time of the current phase and the
estimated time until charge end are displayed (figure 11.10). The time until end of charge is based on
calculation with priorily detected charge durations.

In the line "FA 123 g" (figure 11.10) the amount of formaldehyde that was used during a program run is
indicated in g.

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INDICATION:
Here the pure amount of formaldehyde is indicated, not the amount of sterilizing solution. If necessary,
the amount of sterilizing solution can be calculated.

The MATACHANA sterilizing solution to be used contains 2% (weight percent) formaldehyde.

The consumption depends on the selected program and the quantity of load, it is approx. 8 g/charge
up to 70 g/charge. If these limiting values are undershot or exceeded, a failure message is emitted
(failure 28, 13.2).
Program step skipping Program Change to second
program sequence
(only for customer service) abortion page

Program phase

Figure 11.10
Using the key [ ] it is possible to change from the program sequence page 1 to the program
sequence page 2. On the program sequence page 2 (figure 11.11) all measured values of chamber
pressure and chamber temperature are displayed in real time in graphic form. The measured values of
the last expired 30 minutes are continuously displayed. With program progress the curves shift from
right to left through the display (scrolling), that means the current values are always shown at the right
side of the screen (present bar).

Temperature
scale
Pressure scale

Scrolling of time Automatic feed of time Scrolling of time

axis Back to page 1
axis on/off axis

Figure 11.11
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11.7.2 PROGRAM ABORTION

If it should be necessary during the program run to end it prematurely and to initiate the desorption, the
key [ ] (see figure 11.10) must be pressed for 15 seconds continuously. If the program abortion is
performed in the first vacuum step (before the steam containing formaldehyde has entered the
chamber) the chamber is vented and program end is reached after approx. 90 seconds. If the program
abortion is performed in the further program course, its run is continued with a desorption program to
remove formaldehyde residues. In the program display the message “Program Abortion” appears.”

The desorption program for removing the formaldehyde residues requires – depending on the
sterilization program (60°C or 70°C) and the load – approx. 60-90 minutes.

After the desorption program is completed the chamber door on the loading side may be opened.

CAUTION: In case of a program abortion the unloaded material is in to be regarded UNSTERILE in

any case!

11.7.3 PROGRAM END

If the sterilization program has been completed properly and error free, the program end page is
displayed (see figure 11.12).

Figure 11.12

Additionally the program end is indicated by an acoustic signal.

On the unloading side (two-door sterilizer), the successful process run is displayed as shown in figure 11.13.
Key 1 Key 2

Figure 11.13

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By using key 1 the door on the unloading side is unlocked. Thus it can be opened and the sterilized
material can be removed.

CAUTION!
The inner sides of the door(s) and the chamber are still hot when the load is unloaded! Do not touch
these surfaces, since there is danger of incurring burns. We recommend to wear protective gloves
during removal of the load.

The message ACK (acknowledge) and thus the function of key 2 is only shown if a failure has occurred.
In this case the acoustic signal can be switched off by pressing key 2.

11.8 VACUUM TEST

11.8.1 PROGRAM RUN

If the vacuum test is selected in the program selection menu (figure 11.8), you get to the program
sequence display pages of the vacuum test. The first page 1 of the program sequence display pages
is shown (figure 11.14). Here the vacuum test can be started.

Here different process parameters as temperature, pressure, time etc. are also displayed numerically.
Further, it is possible to lock and/or unlock the loading door, to change to the second program-
sequence display page and to start the program.

Change to second program To help menu

sequence display page
Selected

program Chamber

temperature in °C
Program phase

Estimated time Chamber

pressure in kPa
until end of
charge Batch No.
Expired time

since begin
of charge Formaldehyde
Indication door Consumption

status loading Back to program

side Open door Indication door Start
selection menu
key status unloading program
side

Figure 11.14

To unlock the door on the loading side press [ ].The door can now be opened. If the door is
open the indication shown below appears on the display.

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INDICATION: The vacuum test must be performed if the chamber is empty. The chamber must not
contain any sterilization material!

The test program is started if the key program start [ ] is pressed for several seconds.
After the program has been started it is not possible to leave the program sequence pages 1 and 2
until the program has ended.

Using the key [ ] it is possible to change from the program sequence page 1 to the program sequence
page 2. On the program sequence page 2 all measured values of chamber pressure and chamber
temperature are displayed in real time in graphic form. With program progress the curves shift from
right to left through the display (scrolling), that means the current values are always shown at the right
side of the screen (present bar).

11.8.2 TEST ABORTION

If it should be necessary during the program run to end the vacuum test program prematurely the key
[ ] must be pressed for 15 seconds continuously. If the vacuum test is aborted, the chamber is
immediately ventilated.

11.8.3 END OF PROGRAM

If the vacuum test has been completed properly the program end page is displayed (see figure 11.15).

Figure 11.15

If a vacuum test is completed, an acoustic signal is emitted. Since the vacuum test is no sterilization
program, the sterilizer must be opened on the loading side by pressing [ ].

ATTENTION: With the vacuum test there is no sterilization!

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11.9 SUBSEQUENT PROGRAM WITH LOWER PROCESS TEMPERATURE

If a 60°C sterilization program should be started after a 78°C sterilization program has ended, the
jacked temperature must cool down to the parameters of the 60°C sterilization program priorily.
To do so the program must be selected and the chamber door must be opened to achieve a quicker
cooling down. The display shows the message “Cool down to jacket temperature preset”. The cooling
down from 78°C to 60°C takes approx. 20 minutes. If a 78°C program should be performed after a
60°C program the preheating time is merely approx. 6 minutes

11.10 WARNINGS / FAILURES

During a program run errors or failures may occur. Alarms are emitted due to technical failures or errors.
For further indications on messages please see chapter 13.

INDICATION:
If a warning is indicated (see section 13.1), you should ensure with the displays and other available
information that the sterilization process and/or the sterilization result is not impaired. If in doubt, the
sterilization process should be aborted. Then the result must be discarded and the process must be
repeated. Process abortion is initiated by pressing the key [ ] for 15 seconds continuously.
If there are failures the sterilization program is aborted automatically and subsequently terminated by
a failure recovery program which removes residual formaldehyde. The afterwards unloaded
sterilization material has to be regarded as unsterile in any case!

If the technical failure permits it, a steam desorption is performed as failure recovery program for
removing residual formaldehyde. Otherwise an air flushing is performed. Since the air flushing is not
as effective as the steam desorption, intensified smelling nuisance must be expected when opening
and unloading the chamber. Therefore sufficient ventilation (open windows, switch ventilation/air
conditioning system on full power) of the area must be provided in this case.

The duration of the failure recovery program depends on the selected program (60°C or 78°C), the
failure recovery program itself (air flushing or steam desorption) and the load. According to this
dependence a failure recovery program lasts approx. 60-90 minutes.

Sections 13.2 and 13.3 define each ones of the failures and warnings and their triggering conditions.

If a failure or a warning occurs, this is documented by an indication in the display (figure 11.16).

Failures have a higher priority than warnings. They lead to program abortions and are – additionally to
the indication in the display – indicated by an acoustic alarm (intermittent sound).

After pressing [ ] the type of failure or warning is indicated on the alarm page. In case of failures the
acoustic alarm is switched off too.

Alarm: Indication that a

failure or warning exists.
By pressing this key, the
respective failure or
warning message is
displayed.

Failure/Warning message
display: Indicates that a
message is present and its
description.

46 Figure 11.16
130lf_11_02_00_en
At the end of a failure program the "end of program" page with a failure message is displayed (figure
11.17).

End of program with failure

Figure 11.17

After the recovery program has been completed, the 130 LF can only be opened on the non sterile
area. To unlock the door the release code must be entered.

By touching the blue digit "0" (behind "enter unlock code") you get access to the input menu (figure
11.7). After confirming the unlock code the key [ ] appears on the display. By using this key the door
can be released. The unlock code complies to the last four digits of the device number (see chapter 2)
on the display.

The device No. can be seen on the information page (figure 11.18) or on the inner side of the door to
the operating resources (lower door at the device front) or even, on these front door outer side on a
plate with an E followed by the five last digits of this number.

CAUTION: After completion of a recovery program the sterilization material has to be regarded
UNSTERILE in any case!

11.11 INFORMATION

Press [ ] in the main menu (figure 11.5), to access the information menu (figure 11.18). Here, date,
time, jacket temperature, vaporizer temperature, device number, software version and user level are
indicated. The codes for the levels "Hospital Technique" and "Service" are not shown.

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 Date

Jacket
temperature

Time
Evaporizer
temperature

User level
code
Back to
main menu

Figure 11.18

11.12 STATISTICS

Press [ ] in the main menu (figure 11.5) to access the menu "Statistics" (figure 11.19). Here, the
operating hours, the preset maintenance interval and the remaining hours until the next maintenance
are shown.

Back to main
menu

Figure 11.19

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11.13 MENU OVERVIEW OPERATION

Main Menu

Information Program Selection Login (optional)

Statistics Program ready for operation

Program sequence page 1 Program sequence page 2

Program end

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11.14 PROCESS DOCUMENTATION

11.14.1 GRAPHIC RECORDER

Using the integrated line recorder (fig.7.1/12) the progression of pressure and temperature in the
chamber as well as some basic data and parameters concerning the sterilizer and the process are
printed out. Thereby temperature is continuously recorded in red color on a scale from 0°C to 100°C
on 100 mm paper width (2°C/scale line). Pressure is registered in green color on the same paper with
a scale range from 0 to 100kPa (absolute) (2 kPa/scale line). The paper feed is 120 mm/h. (See
attached graphic recorder instructions in the annex).

Additionally to the alphanumeric printout chamber pressure and temperature as well as some substantial basic
data and parameters referring to the sterilizer and to the process are printed out via the continuous line
recorder. Following adjustments are used for recording:
Scale Range: Temperature Pressure
0-100°C 0-100 kPa
Scale Graduation: 50 s/100 mm.(2°C/s) 40 s/100 mm.(2,5 kPa/s)
Line Color: red green

The time axis proceeds with the line feed and has a scaling of 10 mm. The line feed is 120 mm/h (5
min/cm)

Before starting of a program it has to be ensured that there is enough paper for the recording of the
next charge available in the line recorder and that the quality of the color pencils, namely the quality of
the printout is sufficient.

A sample of a protocol printout of the line recorder with explanations for the respective individual
information elements is shown in attachment A. The printout of the line recorder must be checked after
the end of the charge. It must be checked whether the respective program parameters (vacuum,
pressure, number of conditioning steps, pressure/temperature during holding time, duration of holding
time, vacuum, pressure, number of desorption steps, duration of drying, number of ventilation steps)
have been maintained and thus the process has proceeded properly.

11.14.2 CHARGE PRINTER (OPTIONAL)

During the process all relevant process parameters, messages and alarms are printed out
synchronously via the integrated alphanumeric printer (fig.7.1/2). This permits - additionally to the line
recorder- a numeric charge documentation.

The print-out shows among other data the cycle duration, the individual program phase with time and
pressure indication, the selected program, the holding time, the sterilization pressure and the
temperature as well as user number, charge number, date and manufacturing number.

Eventually occurring failures are also printed. If there is no failure "fault free" is printed out.

(See operating instructions for the alphanumeric printer at section 11.16. See sample printouts in
chapter 21).

11.14.3 PC - PROCESS DOCUMENTATION

Alternatively to the charge documentation system the sterilizer can be connected to a process
documentation system.

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The process documentation system consists of a standard WINDOWS PC to be connected to the
sterilizer via a serial interface (RS232, COM interface). The MATACHANA software CSSDoc must be
installed on the PC. Additionally this software supports functions for remote diagnosis via modem
connection.

For further details on the process documentation system and/or the software please see the specific
technical documentation. Please address your responsible MATACHANA representative.

11.14.4 CONNECTION TO A CHARGE DOCUMENTATION SYSTEM (OPTION)

Optionally the sterilizer can be connected to a PC supported charge documentation system.

Here, for each load a label can be generated at the PC workplace. On this label the data of the load
are given in clear text and in form of a bar code (description of load, sterilization program, date of
packing etc.).

To be able to assign the load to a sterilization charge and a later release, the bar code of the label
must be read at the sterilizer. To read the bar code, a bar code reader (hand scanner) is attached to
the sterilizer. Prior to registering a load bar code the user must identify himself by his personal code at
the sterilizer (entering the personal user bar code). Thereby the bar code page (figure 11.20) is
automatically displayed. If the reading of the bar code has been successful, it is indicated by an
acoustic signal of the scanner.

User code

the currently readout Operator 0000

in barcode Code readout 00 00 00 000000

Operator logged in the last three scanned

Set number barcodes
00 Code 00 00 00 000000
00 00 00 00 000000 Back to main menu
00
00 00 00 000000

Figure 11.20

As soon as the bar code page is displayed, the load bar codes can be read in.

Under "operator" the bar code of the respective user is displayed. Under “code readout” the currently
read in load code is displayed. If a wrong or for the system incorrect code
is entered, a respective message is given on a pop up window in the middle of the screen.
Following messages can be displayed:

Operator logged in
ERROR: OPERATOR INVALIDS (invalid user code)
Read in terminated
Batch cancelled
Set cancelled
ERROR: WRONG CONTROL CODE (invalid control code or bar-code)
ERROR: NOT FOR LTSF (load is not suitable for LTSF-sterilization)
ERROR: MIXED LOAD (load is dimensioned for different programs)
Load OK
ERROR: UNKNOWN CODE (read in code is invalid)
ERROR: MEMORY FULL (quantity of read in codes is too high)

In addition the last three scanned bar codes are shown on the display. Altogether, a maximum of 50
load bar codes can be read in for a charge.

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The reading of load bar codes must be completed by using the control code “end reading” (90
0000000001). Using this control code the “program suggestion page” (figure 11.21) is called up
automatically.

Selection of an alter-
Selection of the Main program Alternative native program
suggested main
program, e.g.
60ºC program
Manual selection
Manual program
selection via
display page

program selec- Back to main menu tion (figure 11.8)

Figure 11.22

After the read in bar codes have been evaluated automatically a suitable main program and/or a
likewise suitable alternative program are suggested.

Press [ ] to access the program selection menu (figure 11.8). There, every available program that
is suitable for the respective load can be selected.

The current process and charge documentation is performed by the charge documentation software
on the connected PC.

Using the (WINDOWS based) provided software, further documentation and integration of sterile
goods supply can be provided via an in-house data network. For details on the so called
MATACHANA Documentation System please, see the respective specific technical documentation.

11.15 OPERATING THE BAG FILLING SYSTEM

3 Hollow

Bag needle
Bag O-ring
emptying gasket
device Fixing
2 4
1 screw
Coupling 5

Bag with head of Bag (1).

Loose the bag emptying device from the coupling (2) of the bag support by pressing clip "A".

Slide bag emptying system with completely withdrawn hollow needle sideways over the bag cover (3).

Press the hollow needle with the fixing screw into the bag cover (4) and turn the fixing screw clockwise until dead stop (5).

Hereby the hollow needle penetrates the inner closing membrane.

Put the bag on the provided bag support and connect it again to the quick coupling. Insert coupling piece "E" into
the coupling on the bag support and let it snap in audibly. After several minutes the bag has completely drained
into the storage container. The empty bag can be removed completely by loosening the quick (clip "A") coupling.

By loosening of the fixing screw anticlockwise, the needle can be removed and the bag emptying device can be
laterally stripped off.
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INDICATION:
The storage container for sterilization solution can contain max. the contents of 2 bags. However,
overloading is technically impossible, since the emptying of the bag is retarded if the storage container
is full with effective solution.

11.16 OPERATING THE CHARGE PRINTER

11.16.1 REPLACEMENT OF THE PAPER ROLL

The last 40 cm are marked by a red line running from the right side to the left as the paper is fed out of
the printer. If necessary a new paper roll must be inserted.

1. Open the front cover by pressing the blue button on the left side. Then the door can be
opened by 180°.
2. Consider the handling instructions on the back side of the printer front door.
3. Cut off the end of the printer paper and transport the paper through the printer by pressing
"Feed". Then pull the rest of the paper through the output slot.
4. Remove the used roll from the fastener.
5. Cut the beginning of the paper strip of the new roll smoothly off (see handling instructions on
the back side of the door printer and figure 11.22).
6. Introduce the paper into the paper feed of the door printer (see sketch on door printer or figure
11.22). Pay attention to the correct winding direction. Now the paper will be drawn in
automatically.
7. Insert the new roll of paper into the fastener.
8. Close the front door of the printer. The paper LED in the front shines red. Press "Feed" in
order to switch off the red LED, stating that the paper has run out. Press "Feed" again until the
paper strip has got several centimeters out of the output slit.

Figure 11.22: Replacement of Paper Roll

INDICATION: If functions of the printer are blocked a reset of the printer must be performed directly
after process end by switching the complete sterilizer off using the main switch (fig.7.1/1). If necessary
a printer self test can be performed. Therefore the key "Feed" must be continuously pressed during
switching on the main switch (fig.7.1/1). The self test protocol is then printed.

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11.16.2 REPLACEMENT OF THE RIBBON

To test the ribbon the latest printout can be checked visually or a test printout can be generated. For
this, reset key of the printer must be pressed continuously while the device is switched on via the main
switch. If necessary the color ribbon must be replaced.

1. Open the lower flap with the paper output slot in the printer front by
pulling lower left corner. Now the flap can be opened by approx. 180°C.

2. Switch off the power supply of the entire device (main switch fig.7.1/1),
after program end.

3. Remove the old ribbon. To do so, remove the small black front plate with the paper output slot
and the small transport wheel behind the flap to the upper right side.

4. Insert the new ribbon. Doing so the paper strip of the roll must be led below the ribbon.

5. Close the front flap.

6. To check for proper function press the key "Feed" continuously while switching on the device
and again by using the main switch.

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12.MAINTENANCE, ADJUSTMENTS AND PARAMETER CHANGES

12.1 MAINTENANCE AND ADJUSTMENTS

From the main menu (figure 11.5) you can access the display pages that are needed for maintenance,
adjustment and parameter changes. Press [ ] to access the pages for the maintenance menus
(figure 12.1).
Hospital technical Changing

maintenance of program
menu parameters
(drying time)
Password

assignment and
Access only for administration
MATACHANA
customer service
Back to main

menu

Figure 12.1

After activating the keys [ ], [ ] or [ ] you are requested to enter a password. The
preset password for this maintenance level is 1234. It can be changed in the respective menu (see
chapter 12.4).

12.2 MAINTENANCE MENU

To access the maintenance menu (figure 12.2) you must activate the icon [ ] on the display
page for access to the maintenance menus (figure 12.1).

Indication of
all analogous
values, Basic settings
temperature,
pressure
Alarm- Indication and/or

printout of process
History data of the last 10
charges
Back to access

to maintenance
menu
Figure 12.2

55
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The functions of the icons are described individually below.

Upon pressing this icon, the submenu "Temperature display" (figure 12.3) is called up. Here all
analogous values (pressure and temperature) can be read.

Chamber pressure
Chamber sensors 1 and 2

Temperature Jacket temperature

Sensors 1 and 2
of the different
Jacket heating zones:
temperature door/s and bottom
of the different Temperature of the
heating zones
pump operating
around chamber
water
Steam generator
temperature Back to

maintenance menu

Figure 12.3

Upon pressing this icon, the submenu "basic settings" (figure 12.4) is called up. Here screen
contrasts may be adjusted, languages selected and time, date and charge number can be read.

Charge

Date number

Time

Selection of
language
Display (touch national
contrast banner)
Russian

Back to

German Spanish English Japanese maintenance menu

Figure 12.4

Upon activating this icon, the submenu "alarm history" (figure 12.5) is called up. Here the last
256 warnings and failures can be called up. Date, time, type and number of failure are displayed.

56
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 Failure
display

Return
Back to
maintenance menu

Figure 12.5

Upon pressing this icon, the submenu "process data" (figure 12.6) is called up. Here, the
process data of the last 10 charges, such as time, temperature and pressure at program start, begin
and end of holding time and at program end; date, charge number, program, user and eventually
occurred failures can be read.
By pressing [ ] the currently displayed charges could be completely printed out (if the optional
printer is installed). To print out the process data is only possible in stand-by.

Printout

Back to previous Forward to next Back to maintenance

charge charge menu

Figure 12.6

12.2.1 ADJUSTING DATE AND TIME

On the display page “information” (fig. 11.18) and the page “basic settings” (fig. 12.4) the date and
time that are implemented in the system are displayed. To change the date or time you must touch the
date or time indication on one of the two pages.

Then the date and time are displayed on a new display page.

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On this page, date and time can be adjusted by using the arrow keys [ [ ] The next field, e. g.
minutes of the time indication can be selected by using the key [ ].

If the adjustments are completed, you must leave this page by pressing [ ]. Now the adjustments
of date and time are corrected at the display. To adopt these adjustments to the control and the line
recorder, the device must be switched off via the main switch and after approx. 20 seconds
switched on again.

12.3 CHANGING OF PARAMETERS

Press [ ] in the display for access to the maintenance menu (figure 12.1) in order to access the
selection of programs for changing the program parameters (figure 12.7).

Back to main menu

Figure 12.7

By pressing the respective icon you get access to the page where the program parameters for the
respective program can be changed (figure 12.8). For the 60°C program, the 78°C program solely the
drying time can be changed by touching the blue digits. The new drying time can be entered in the
automatically displayed input page (figure 11.7) and confirmed by pressing enter. It is not possible to
change parameters for the vacuum test program.

Changing of
drying time

Back to program
selection menu

Figure 12.8
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12.4 PASSWORD ASSIGNMENT

It is only possible to assign passwords if the input of user codes is activated in the MATACHANA
configuration menu.
By pressing [ ] in the display for access to the maintenance menu (figure 12.1) you can access the
menu where passwords can be changed (figure 12.9).

Passwords can be changed by touching the blue digit. Then a new password can be entered in the
automatically displayed input page (figure 11.7) and confirmed by enter. Maximally 8 different codes
with a maximum length of six digits can be assigned to users. For the area hospital Technical Service
only one code can be assigned.

Back to maintenance
menu

Figure 12.9

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12.5 MENU OVERVIEW MAINTENANCE

Program Selection Access to Maintenance Menu

Passwords

Change Program Parameters

Temperature Indication Maintenance Menu Basic Settings

Alarm list
Process Data

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12.6 SPECIAL FUNCTION "POWER SAVE FUNCTION"

As a special function the "Power Save Function" can be activated by the Technical Service in the
menu device adjustment. If this function is active, the chamber and steam generator heatings are
switched off one hour after program end if the unloading door has not been opened.

If the chamber door is opened for unloading before one hour has elapsed from the last cycle, the
heatings are switched on again and this function is not operative.
A new program run can only be started, if the preheating phase has ended (heating to 60°C, approx.
14 minutes).

This function can be activated on request, if a program is started at the end of a working day and in the
case that the sterilizer is going to be unloaded the next working day.

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13. FAILURES AND WARNINGS

13.1 MEANINGS AND RESULTS OF FAILURES/WARNINGS

During a program run failures / warnings may occur. They are actuated due to technical failures or
errors and can be divided into two groups:

a) Interrupting failures with indications to cause or results and simultaneous process abortion,
since it is not possible to ensure a correct sterilization result. The process is aborted with a
respective failure message and a safety routine (desorption) follows automatically. After
completion of the safety routine the door on the loading side (NSD) can be opened and the
unsterile material can be removed. These messages can not be suppressed before process
end (including safety routine).

On the process sequence display page the failure is indicated (figure 11.18). At the end of the process
the failure is shown once again, to indicate that the process was incorrect and that the material is to be
regarded unsterile. Additionally the failure is documented on the line recorder and if available, on the
printer (optional).

ATTENTION: If a process is aborted with a failure, the material principally has to be regarded as
unsterile and/or must be marked accordingly!

b) Warning messages also with indications of causes and results. The consequence here is not a
process abortion because the sterilization result is not yet endangered. If necessary the user
can ensure the proper completion of the sterilization by corrective actions, or the corrective
action must take place before starting a next sterilization cycle. However, before releasing the
sterilization material it should be checked whether the process relevant parameters have been
maintained. This could be achieved by checking the displayed and/or recorded measured
values for correctness.

INDICATION:
With each indication of an error, it should be ensured by means of the displays and available information
that the sterilization process and/or the sterilization result is not affected. However, if it is not sure the
process has been really not impaired it should be aborted. The result then must be discarded and
the sterilization must be repeated. To abort a sterilization process press [ ] for 15 seconds
continuously.

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13.2 LIST OF FAILURES

The following list defines the individual failures and their triggering conditions and results:

FAILURE 1-7: TEMPERATURE SENSOR

Meaning: A temperature sensor of the chamber or jacket heating registers wrong values (chamber
temperature above 149°C or below 0°C).
Initiation: Anytime.
Results: If a program is currently in progress it is interrupted, and the recovery program steam
flushing takes place. If the sterilizer is in stand-by a program start is not possible.

FAILURE 8: TEMPERATURE SENSOR EVAPORATOR

Meaning: The temperature sensor registers wrong values (temperature above 149°C or below
0°C).
Initiation If a program is currently in progress it is interrupted, and the recovery program air
flushing takes place and the evaporator heating is switched off. If the sterilizer is in
stand-by a program start is not possible.

FAILURE 9,10: PRESSURE SENSOR CHAMBER

Meaning: Signal of pressure sensor results in a pressure <3 mbar after conversion.
Initiation: Anytime.
Results: If a process is currently running is interrupted, and depending on the sensor the
recovery program air flushing or steam flushing takes place. If the sterilizer is in stand-
by a program start is not possible.

FAILURE 11: MOTOR PROTECTION SWITCH VACUUM PUMP

Meaning: No signal from the motor protection switch.
Initiation: Anytime.
Results: If a process is currently running, the vacuum valve will be closed and/or a recovery
program is performed. If the sterilizer is in stand-by a program start is not possible.

FAILURE 12: TEMPERATURE CHECK LOW TEMPERATURE

Meaning: The chamber temperature has fallen by more than 1°C below the nominal sterilization
temperature.
Initiation: During holding time / sterilization.
Results: If the temperature difference is more than 1°C, the cycle is interrupted, and the recovery
program steam is performed.

FAILURE 13: TEMPERATURE CHECK HIGH TEMPERATURE

Meaning: The chamber temperature is more than 4°C above nominal sterilization temperature.
Initiation: During holding time / sterilization.
Results: If the temperature difference is more than 4°C, the cycle is interrupted and the recovery
program steam flushing is performed.

FAILURE 14: TIME MONITORING VACUUM SWITCH POINT

Meaning: The vacuum switch point is not reached in the respective program step within the given
time.
Initiation: Vacuum phase.
Results: If a program is currently running it is interrupted, and the recovery program air flushing
is performed. If the alarm occurs during a steam flushing, the recovery program air
flushing is performed. During a vacuum test the chamber is immediately ventilated.

FAILURE 15: TIME MONITORING PRESSURE RISE

Meaning: The pressure switch point is not reached in the respective program step within the
given time.
Initiation: Phase of pressure increase.
Results: The recovery program air flushing is performed.

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FAILURE 16: PRESSURE CHECK: LEAKAGE
Meaning: During the holding time the nominal pressure is exceeded by >0,5 mbar/min.
Initiation: during holding time
Results: The recovery program steam flushing is performed.

FAILURE 17: PRESSURE CHECK: DEVIATION OF SENSORS

Meaning: Both sensors differ by more than 10 mbar.
Initiation: Anytime.
Results: If a program is currently running it is interrupted and the recovery program steam
flushing is performed. If the sterilizer is in stand-by a program start is not possible.

FAILURE 18: PRESSURE CHECK: VACUUM TEST NEGATIVE

Meaning: During the vacuum test the chamber pressure increases by more than 1 mbar/min.
Initiation: During test time of the vacuum test.
Results: Immediate venting of the chamber.

FAILURE 19: DS-WATER FEEDING SYSTEM BLOCKED

Meaning: Pressure in the DS-feeding line exceeds 5 bar.
Initiation: During evaporator flushing in the program step desorption.
Results: If a process is running the failure program air flushing is performed because steam
flushing is not possible. The pressure in the DS-water feeding system exceeds the
maximum value due to a blockade/contamination. Maybe the sterile filter (fig. 7. 1/5) is
blocked and must be exchanged (see 14.3).

FAILURE 20: HIGH TEMPERATURE JACKET HEATING

Meaning: During the program run the jacket temperatures are more than 4°C above the nominal
temperature for a longer time-period than 120 seconds.
Initiation: Anytime.
Results: If a program is currently running, it is interrupted, and the recovery program air flushing
is performed. If the sterilizer is in stand-by a program start is not possible

FAILURE 21: LOW TEMPERATURE JACKET HEATING

Meaning: During a program run the jacket temperatures are more than 4°C below the nominal
temperature for a period of more than 3 minutes.
Initiation: Anytime.
Results: If a program is currently running it is interrupted, and the recovery program steam
flushing is performed. If the sterilizer is in stand-by a program start is not possible.

FAILURE 22: HIGH TEMPERATURE EVAPORATOR

Meaning: During a program run or stand-by the evaporator temperature is for more than 30
seconds continuously above 145°C.
Initiation: Anytime.
Results: If a program is currently running it is interrupted, and the recovery program air flushing
is performed. If the sterilizer is in stand-by a program start is not possible.

FAILURE 23: LOW TEMPERATURE EVAPORATOR

Meaning: During a program run the evaporator temperature is continuously below 100°C for
more than 5 minutes.
Initiation: During program run.
Results: The recovery program air flushing is performed.

FAILURE 24, DOOR CLOSURE LOADING SIDE; DOOR LOCK

27 : LOADING SIDE
Meaning: The door on the loading side is still open or not locked or a locking is indicated although
the door is not locked and vice versa.
Initiation: Anytime.
Results: If a program is currently running it is interrupted, and the recovery program steam
flushing is performed. If the sterilizer is in stand-by a program start is not possible.

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FAILURE 25, DOOR CLOSURE UNLOADING SIDE; DOOR LOCK UNLOADING 26: SIDE
Meaning: The door on the unloading side is still open or not locked or a locking is indicated
although the door is not locked and vice versa.
Initiation: Anytime.
Results: If a program is currently running it is interrupted, and the recovery program steam
flushing is performed. If the sterilizer is in stand-by a program start is not possible.

FAILURE 28: FA SOLUTION DOSAGE

Meaning: a) During the sterilization the minimum amount of post-feedings has not been reached
(3 feeding / 10 minutes).
b) The fed FA amount is not within the range of 8 g/charge to 70 g/charge.
Initiation: a) During holding time / sterilization
b) After holding time / sterilization
Results: The program is interrupted, and the recovery program steam flushing is performed.

FAILURE 29: MANUAL PROGRAM ABORT

Meaning: Pressing the program abortion key for 15 seconds during program run.
Initiation: During program run.
Results: If a program is currently running it is interrupted and the recovery program steam
flushing is performed. During a vacuum test the chamber is ventilated immediately.

FAILURE 30: SEQUENCE BUTTON PRESSED

Meaning: The sequence button has been operated during a program run (only accessible for
MATACHANA Technical Service).
Initiation: Anytime.
Results: Program goes a step forward. The display shows "Sequence button pressed".

FAILURE 31: MONITORING FA VALVE

Meaning: Faulty dosage of sterilizing solution into the evaporator
Initiation: During feeding of sterilizing solution.
Results: If a program is currently running it is interrupted and the recovery program steam
flushing is performed.

FAILURE 32: MONITORING DI VALVE

Meaning: Faulty dosage of DI water into the evaporator
Initiation: During DI water feeding
Results: If a program is currently running it is interrupted and the recovery program air flushing
is performed.

IMPORTANT:

If failures occur during a process that result in process abortion a recovery program is started
automatically to bring the sterilizer into a safe and defined operating condition so that the door can be
opened without any risk.

In case of failures of the sterilizer the authorized personnel must be informed. If the source of the
failure can not be detected and/or removed, the respective Technical Service must be informed.

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13.3 MESSAGES AND WARNING MESSAGES

The following list defines the respective messages and their causes and results:

MESSAGE 1: SYSTEM READY TO START

Meaning: All required conditions are fulfilled.
Initiation: During stand-by.
Results: Programs can be selected and chosen.

MESSAGE 2: PROGRAM RUNNING

Meaning: The sterilizer is operating and there is no failure or warning.
Initiation: During program run.
Results: The program is running

MESSAGE 3: CYCLE COMPLETE WITHOUT ERROR (no indication on the display)

Meaning: The selected program has been completed without errors. The sterilizer has not yet
been unloaded.
Initiation: After program end.
Results: The program run has been successful. The sterilizer may be unloaded.

MESSAGE 4: CYCLE COMPLETE WITH FAULT (no indication on the display)

Meaning: The selected program has been completed with failures. The sterilizer is not yet
unloaded.
Initiation: After program end.
Results: The program run was not successful. The unsterile material can only be unloaded after
a special unlocking-code has been entered.

MESSAGE 5: COOL DOWN TO JACKET TEMPERATURE PRESET

Meaning: The jacket temperature is 4°C above nominal temperature (e.g. when selecting the
60°C program after a 78°C).
Initiation: In stand-by.
Results: A program start is not possible.

MESSAGE 6: PREHEAT TO JACKET TEMPERATURE PRESET

Meaning: The jacket temperature is 4°C below nominal temperature.
Initiation: During stand-by.
Results: A program start is not possible.

MESSAGE 7: PREHEAT TO EVAPORATOR TEMPERATURE PRESET

Meaning: The evaporator temperature is below 100°C.
Initiation: During stand-by.
Results: A program start is not possible.

MESSAGE 8: TEMPERATURE CHECK. TEMPERATURE BELOW < 1 K

Meaning: The nominal temperature decreases by more than 1K.
Initiation: During holding time / sterilization.
Results: The progress of the holding time is stopped as long as this message is present.

MESSAGE 9: FORMALDEHYDE SOLUTION LOW

Meaning: Floating switch of formaldehyde solution signalizes minimum reached / undershot.
Initiation: Anytime.
Results: A running program will be ended regularly. A program start is not possible. Sterilization
solution must be refilled.

MESSAGE 10: RESERVE

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MESSAGE 11: DEIONIZED WATER LOW
Meaning: Floating switch of DI water container signalizes minimum reached / undershot.
Initiation: Anytime.
Results: A running program will be ended regularly. A program start is not possible. The DI-water
supply must be ensured.

MESSAGE 12: DEIONIZED WATER QUALITY BAD

Meaning: The conductivity of the DI-water is outside the permissible range.
Initiation: Anytime.
Results: A program start is still possible for 5 times. The DI-water cartridge must be renewed.

MESSAGE 13: CHANGE DEIONIZED WATER CARTRIDGE

Meaning: Conductivity of the water is outside the permissible range.
Initiation: Anytime.
Results: A program start is no longer possible.

MESSAGE 14: BUFFER BATTERY FLAT

Meaning: The buffer battery of the control (PLC) is discharged / not available.
Initiation: Anytime.
Results: A program start is possible.

ATTENTION!
The main switch of the sterilizer may not be switched off, in order to not loose any data. The buffer
battery must be exchanged immediately.

MESSAGE 15 SENSOR DI MONITORING DEFECTIVE

Meaning: The pressure sensor in the DI-water feeding line is defective.
Initiation: anytime
Results: A program start is not possible.

MESSAGE 16: SERVICE DUE

Meaning: The preset operating hours for the next preventive maintenance measures have
expired.
Initiation: Anytime.
Results: Please arrange that the maintenance is performed by the MATACHANA Technical
Service. This message appears every time when the sterilizer is switched on to
remind the user of the maintenance. A program start is possible.

MESSAGE 17: SENSOR FORMALDEHYDE SOLUTION DEFECTIVE

Meaning: The pressure sensor in the FA sterilizing solution feeding lines defective.
Initiation: anytime
Results: A program start is not possible.

MESSAGE 18: VACUUM PUMP WATER LOW

Meaning: No signal of the filling level limiter switch for more than 4 minutes.
Initiation: Anytime.
Results: During a program run the vacuum valve will be closed, the pump switched off. If the
water level is sufficient again in due time (on-site valve has been opened) the program
is continued. Otherwise a recovery program is performed. If the sterilizer is in stand-by
a program start is not possible.

MESSAGE 19: PUMP WATER TEMPERATURE SENSOR

Meaning: After conversion the signal results in a temperature of < -1°C or >149°C.
Initiation: Anytime.
Results: If a process is currently running after effects (e. g. time monitoring) may occur. If the
sterilizer is in standby a program start is not possible.

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MESSAGE 20: POWER FAILURE
Meaning: Failure of the electrical supply.
Initiation: During program run.
Results: The program continuous to run, only a message is displayed. In cases of a longer
power failure, other failures (e. g. temperature too low) may occur.

MESSAGE 21: DOOR LOADING SIDE IS OPEN

Meaning: Door on the loading side is open.
Initiation: in stand-by
Results: A program start is not possible.

MESSAGE 22: DOOR UNLOADING SIDE IS OPEN (two-door sterilizers)

Meaning: Door on the unloading side is open.
Initiation: in stand-by
Results: A program start is not possible.

MESSAGE 23: BATTERY OPERATING PANEL LOADING SIDE LOW

Meaning: The buffer battery of the display is discharged.
Initiation: anytime
Results: A program start is possible

ATTENTION!
Exchange the buffer battery immediately!

MESSAGE 24: BATTERY OPERATING PANEL UNLOADING SIDE FLAT

Meaning: The buffer battery of the display is discharged.
Initiation: anytime
Results: A program start is possible

ATTENTION!
Exchange the buffer battery immediately!

13.4 DISTURBANCES OF THE OPERATIONAL READINESS

If a sterilizer is not operational upon pressing the start button (or earlier), the following points have to
be checked:

· Is there a failure or a message?

see chapter 13.

· Is (are) the chamber door(s) properly closed?

The chamber door(s) must be closed until firm dead stop.

· Has a fuse blown?

Inspect the fuses in the electro-cabinet and in the on-site main fuse of the sterilizer (by the
technical service).

· Is the motor protection switch for the vacuum pump switched on?
The switch is located in the electro-cabinet and must be in position "1".

· Is water for the operation of the motor vacuum pump available?

Minimum water pressure 2,5 bar

In case of failures of the device the authorized personnel must be informed. If the cause is not
detected and/or can not be eliminated, the respective Technical Service must be informed.

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14. CARE, MAINTENANCE AND SCHEDULED WORK

14.1 GENERAL

To maintain the adaptability of the machine, routine maintenance work is necessary. It has to be
carried out through the user/operator respectively through a trained equipment warden.

The inspection and maintenance actions are allowed to be performed only by trained technical
experts.

We recommend inspection and maintenance including control of all safety devices by our authorized
service organizations every half year and a maintenance contract.

According to EN 14180 (section 9.5), repair actions at the machine are only allowed to be performed
by the manufacturer or its authorized service organizations. Furthermore a technical safety check (e.
g. safety valve at steam generator, overheating protection at steam generator) through an expert has
to be performed at least once a year.

14.2 SERVICE ATTENDANCE

Basically, the cold or still warm sterilization chamber should be cleaned once a week. All incrustations
have to be removed. Since the chamber consists of anodized aluminum, mechanical techniques, such
as scouring and grinding must not be favored. Cleaning agents have to be halide free and may not
contain any residues.

ATTENTION:
To flush the chamber again after cleaning, demineralized or distilled water has to be used.
While cleaning the chamber, make sure that waste water may not get into the drain of the chamber.
Clean gaskets with cleaning agents similar to the chamber one.
Subsequently flush them again with plentiful clear water and sweep them dry.

CAUTION!
The apparatus is not explosion safe. Therefore the outer covering may not be treated with cleaning or
disinfection medium which might create an ignitable explosive mixture in connection with air.

14.3 MAINTENANCE

- Change of Door Seal

·Remove the door sealing from groove at the inner side of the door.
· Insert the new door sealing into the four corners of the groove. Then press smoothly and evenly the
other parts of the sealing into the groove.

- Change of Venting Filter (fig. 7.1/9)

ATTENTION:
· Before changing the filter switch off the unit.
· Remove the respective filter and exchange it against a new one.
· Adjust the new filter in its new position.
· Switch on the unit.

- Change of DI-water/Solution Filter (Hose Filter)

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ATENTION:
• Before changing the filter switch off the unit.
• Remove the respective filter/unplug the hoses and exchange it against a new filter.
• Plug the hoses in and secure them with hose clamps.
• Switch on the unit.

- Change of DI-water sterile Filter (fig. 7.1/5)

CAUTION:
· Before changing the filter switch off the unit remove the respective filter by loosening the quick
couplings.
· Insert new filter by attachment (with audible snap in) of the quick couplings.
· Switch on the unit.

- Decalcification Tablet (fig. 7.1/14)

· If the water quality is bad, (conductivity >1500 µs/cm and/or hardness > 30°dH) we recommend to
insert a new decalcification tablet regularly (after approx. 30-40 charges) and/or monthly.

- Exchange of DI-water Cartridge (fig. 7.1/15)

The indication to change the cartridge is given in the display.

INDICATION: The sterilizer can not be started again after this message.

After this message the DI-water cartridge must be exchanged in the next operation break.

- Close the water tap.

- Screw off housing cup (fig. 7.1/15).
- Remove exhausted cartridge and insert the new one.
- Screw on housing cup, take care of the seal.
- Open the water tap.

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14.4 SCHEDULED MAINTENANCE PLAN

No.. Checkpoint / Test / Action Reference Time of Work

Description
1 Chamber floor Cleaning by user / caretaker Acc. to section14.2 Weekly

Insert rack
2 Door seal Cleaning, visual test, vacuum Acc. to section 9.3 Weekly

test
3 Chamber door change of seal by user / Acc. to section14.3 When necessary

caretaker
4 DI-water- Exchange by user / caretaker Acc. to section14.3 Upon indication in display

cartridge (message 12; see 13.3)

or at least every 8 weeks
5 DI-water filter Exchange by user / caretaker Acc. to section14.3 1/2-yearly

6 Total device Inspection and maintenance, Acc. to section14.1 1/2-yearly

function control Technical

Service
7 FA-solution Exchange by user / caretaker Acc. to section 14.3 Yearly

filter
8 Venting filter Exchange by user / caretaker Acc. to section14.3 Yearly

9 DI-water sterile Exchange by user / caretaker Acc. to section14.3 1/2-yearly

filter
10 Decalcification Exchange by user / caretaker Acc. to section14.3 Monthly

Tablet
11 Total device safety relevant examination Acc. to section14.1 Yearly

Technical Service expert

12 Total device Overhaul by manufacturer or Every 5 years

authorized Technical Service

14.5 PUTTING OUT OF OPERATION IN CASE OF SHUTDOWN OR TRANSPORT

Before longer periods of standstill (more than 8 days) the DI-water sterile filter (7.1/15) must be
disassembled. In case of reconnection a new filter must be installed.

- For transportation, the main electrical supply line shall be disassembled by an expert only
(disconnect mains supply first from the electrical supply net side).
- Disconnect the tubes for the water supply system and remove water rests.
- Open the drain valve and completely drain the storage reservoir with housing cup
- Wipe out and dry the chamber.
- Clean and dry the gaskets and baskets and store them in the sterilization chamber, protect them
against pushes during transport.
- Pack the apparatus and the connecting hoses.

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15. DISPOSAL

For disposal of FA-sterilizing solution bags see 10.9.2. The disposal of indicators is described in
section 10.10.1. Indications concerning disposal of DI-water cartridge can be found in section 14.3.

The following parts can be directly disposed with the usual waste or by the manufacturer if they are
delivered free of charge.
· Wrapping of the sterilizer.
· Door seal.
· Connection hoses G¾.
· Wire baskets.
· Venting filter.
· Hose filter DI-water / FA-solution.
· Spare parts for line recorder and printer.
· Sterilizing solution bags.

After termination of the sterilizer utilization and before disassembling, the sterilizing solution piping
system must be drained and flushed with water. The following disposal and recycling information shall
be taken into consideration.

In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic

Equipment (WEEE), this device belongs to the category of electrical and electronic
equipment subject to the terms of separate collection and recycling at the end of its
useful life. For this reason, the equipment bears the symbol of separate collection of
electrical and electronic equipment, represented by a wheeled bin with crossed signal.
This means that, at the end if its useful life, it must not be disposed off together with
other urban waste, but must be collected and transported to a waste treatment centre
duly authorized by the competent authority. This equipment should be properly treated,
emphasizing, in this order, reuse, recycling, energy recovery and disposal, neutralizing
any substances harmful to human health and the environment.

The regulations and laws in force in each country should be observed.

Participating in the selective collection scheme contributes to reducing the misuse of natural
resources. For further information, consult your local authorities (city council, regional government,
ministry of environment, etc.), the manufacturer of the device or your local distributor.

General recommendations regarding disposal of batteries:

● Batteries contain chemical products harmful to the environment. Do not dispose of them with
general household or urban waste.

● Dispose of them at authorized collection points.

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16. STANDARDS AND CE-CONFORMITY

According to the EEC Medical Device Directive (MDD) 93/42/EEC the formaldehyde sterilizer
MATACHANA 130 LF is a medical device and with reference to Annex IX of the MDD, is classified as
class IIb medical device. This holds true similarly for the safety bag filling system with the sterilizing
solution and the respective connection device all together being part of an integrated safety concept.

The company ANTONIO MATACHANA, S.A. has established a quality management system according
to the standards EN ISO 9001 and EN ISO 13485 which are specific for the quality systems and have
been approved by a Notified Body applying the Annexe II, article 3 of the MDD.

On this base, the formaldehyde sterilizer MATACHANA 130 LF together with the filling system as well
as its accessories according to this Operating Instruction has been applied to a regular procedure for
evaluation of conformity and have been proved to be compliant with the essential requirements of
Annexe I of the EC regulation 93/42/EEC. This allows the sterilizer to be marked as a Medical Device,
with mention of the Notified Body 0197, by the label:

A respective formal Declaration of Conformity has been duly signed.

By compliance with a.m. MDD 93/42/EEC the sterilizer type 130 LF in accordance with this instruction
manual also fulfills the relevant essential requirements of the EEC regulations as listed below:

- 2006/95/EC Directive (Low Voltage Directive)

- 2004/108/EC Directive (Electromagnetical Compatibility)
- 2006/42/EC Directive (Machine Directive)

As far as applicable for a.m. directives the standards EN 61010-1, EN 61010-2-040, EN 60204-1, EN
61326-1 as well as applicable standards of series DIN VDE 0100 according IEC 364 comply with 130 LF.

Furthermore this sterilizer complies with the requirements of the standard EN 14180 and DIN 58948.

The sterilizer contains a steam generator which is excluded from applying the Pressure Equipment
Directive 97/23/EC (PED). We hereby confirm that the steam generator was constructed,
manufactured and tested according to the applicable technical regulations and the AD-regulations.

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17. GUARANTEE

ANTONIO MATACHANA, S.A. guaranties its equipment against all defects due to a manufacturing or
operation process, during a term of 12 months since the installation’s date of the device, or 15 months
as from the delivery date; whatever situation occurs first, and as per the conditions established below:

1. To replace free of charge any parts that has been proven to have a fault due to the
manufacturing process during the term stipulated above; this includes the spare parts the cost
of labour needed for its replacement as well as the consignment cost. The replacement tasks of
the spare parts will have to be undertaken by Antonio Matachana, S.A. or an authorized service
dealer of the company, based upon written instruction duly sent by the customer. Replaced
parts becomes property of the supplier.

2. The replacement of parts within the warranty period will not imply its extension. Nevertheless,
the warranty may be extended in accordance with the time margin during which the device is
not in operation due to this fault and its subsequent repair.

3. This guarantee does not cover any breakdown caused by natural wear or accident through
negligence, incorrect or erroneous maintenance, any installation or use not complying with this
operating instruction manual, and any use of consumables not in accordance with the specifications
determined by Antonio Matachana, S.A. It is also understood by a non-compliant or inappropriate
maintenance when the period of time planned for preventive maintenance is not respected or if the
maintenance is performed by a personnel not authorized specifically by Antonio Matachana, S.A.

4. The warranty is not valid for those parts and consumable products required for the correct
operation of the sterilizers such as paper used for the printer, grease and lubricants, sterile air
filter as well as water filters, including sealing gaskets (for door, “clamp”, pneumatic cylinders,
O-ring seals, abutting joints, etc.) and membranes; as well as batteries, fuses, lights and bulbs.

5. The warranty does not cover any case of modifications done to the original spare parts, or in the
case repair undertaken with parts different from the ones supplied by Antonio Matachana, S.A.
and executed by non-authorized third parties.

6. Furthermore, the warranty is not valid for those interventions in which the reported faulty part
has not been detected, as well as the cases of force majeure such as atmospheric and
geological phenomenon, water, fire etc.

7. In all the cases, the customer’s right to lodge a complaint on the damages produced by
impairment will expire after 6 months.

8. This guarantee does not apply to the repair tasks. This latter are subjected to their own specific
conditions.

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18. SPARE PARTS AND ACCESSORIES

We recommend using only original MATACHANA replacement parts and accessories. Otherwise
flawless function and/or error-free processing cannot be ensured.

The replacement and accessory parts are obtainable from the manufacturer or an authorized
Customer Service Department. Consult other spare parts on the list of material which is included with
the diagrams (see the General Index from the documentation)

Code Function Description

41184.1 Fuse 20 mm. 6,3 A, 230 V circuit protection

41185 Fuse glass supertempoloop 5 A, 20 mm. long

41608.1 Sterile air filter, sterilizer Series 130 LF

41625.5 Line recorder paper 114, Yokogawa (if instaleld)

41625.2 Red pen, for line recorder (if installed)

41625.3 Green pen, for line recorder (if installed)

41625.6 Plotter text pen (If intalled)

- 41602.8 Recorder paper for printer, 52 mm. wide

- 41602.5 Tape for printer, black color DBM 920-40-
- 50897.1 Turbogel jar with 250 gr-teflon grease
- 41768.4 Silicone door gasket 130 LF
85430 Box of 3 sterilizing solution bags

85690.1 Self-adhesive indicators spots.

Process chemical indicator Class 1 acc. to EN ISO 11140-1

85690.2 Box of 250 strips, each with 2 chemical indicators Class 4 acc. to EN
ISO 11140-1.

85694.5 Adhesive tape specific for LTSF sterilization. Process chemical

indicator Class 1 acc. to EN ISO 11140-1.
Box of 24 individually packed reels

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 Code Function Description
85431.5 Chemical control kit for LTSF sterilization charge control.
Box of 200 chemical indicator strips Class 2 acc. to EN ISO 11140-1
and 1 test device acc. to EN 867-5

85458.9 Biological self-contained indicator acc. to EN ISO 11138-5, specially

indicated for Matachana LTSF process.
Box of 100 biological indicators

85458.2 Incubator for LTSF self-contained biological indicators. Temperature

57 to 60 ºC

85699 Incubator for self-contained biological indicators of different sizes.

Temperatures: 37 ºC or 60 ºC

85458.7 Biological control kit for LTSF sterilization with:

25 biological indicator strips acc. to EN ISO 11138-5 to be used with
the test device.
25 tubes of culture media for incubation

- 85458 Biological indicator strips acc. to EN ISO 11138-5 to be used with the
test device.
Box of 50 strips.

85458.5 Test device acc.to EN 867-5. To be used with either chemical or

biological indicators.

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19. SWITCHPOINTS AND TOLERANCES

PRESSURE PROFILE OF A STERILIZATION PROCESS:

Time
Start End venting

Holding Time Desorption Flushing Post-flushing

Conditioning Drying Venting

Consumption of Sterilization Solution resp. Feeding of Formaldehyde

The display line "FA" indicates the quantity of formaldehyde in grams that is applied into the process
during a program run (see section 11.7.1). The consumption depends on the selected program and the
quantity of load, it must be comprised between 8g /charge and 70 g/charge.

The system for determination of the applied quantity of formaldehyde works with a accuracy of ± 5%.

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Switchpoints for the 60°C - Program:
No. Phase Pressure Temperatu- Duration Quantity Remarks
[kPa] re [°C]

1 Conditioning Vacuum 5,3 (+/-1,5) Not specified Max: 1.– 4. 12

12 min 5.-15.
8 min
2 Holding Phase Vacuum 5,3 (+/-1,5) Not specified 15 s 17
3 Conditioning Pressure 21,8(+/-1,5) Not specified Max: 8 min 17
4 Holding PhasePressure 21,8 (+/-1,5) Not specified 15 s 13
5 Conditioning 13.Vacuum 10,0 (+/-1,5) Not specified Max. 8 min 1
6 Conditioning 14.Vacuum 150 (+/-1,5) Not specified Max. 8 min 1
7 Conditioning 15.-17. 18,8 (+/-1,5) Not specified Max. 8 min 3
Vacuum
8 Holding Phase Pressure 21,8 (+/-1,5) Not specified 90 s 3
14.-16. Pressure
9 Holding Phase Pressure 21.8 (+/-´1,5) Not specified 15s 1 Directly before start
17. holding time
10 Sterilization 21,8 (+/-1,5) 60,0 (+4/-0) 30 min 3x10 min
11 Intermediate Vacuum 18,8 (+/-1,5) Not specified 15 s Every 10 min during
Sterilization
12 Desorption Vacuum (upon 6,5 (+/-1,5) Not specified Max: 8 min 25
start of the first vacuum
phase a pressure decrease
in the vaporizer takes
place)
13 Holding Phase Vacuum 6,5 (+/-1,5) Not specified 10 s 25
14 Desorption Pressure 21,1 (+/-1,5) Typically: Max: 8 min 25
>58
15 Holding Phase Pressure 21,1 (+/-1,5) Typically: 30 s 25
>58
16 Vacuum Drying 2 (+2/-1,5) Not specified 10 min 1
17 Flushing Pressure 74 resp. p0 Not specified Max: 8 min 5
=101,3 (+/-
1,5)
18 Flushing Vacuum 6,5 (+/-1,5) Not specified Max: 8 min 5
19 Ventilation p0 =101,3 Not specified 80 s 1
(80,0-108,0)
20 Post Ventilation Vacuum 6,5 (+/-1,5) Not specified Max: 8 min Every 30 minutes
21 Post Ventilation Pressure p0 =101,3 Not specified Max: 8 min Every 30 minutes
(80,0-108,0)
- Temperature Chamber 61°C +/-5°C
Wall during all Program
Run

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Switchpoints for the 78°C - Program:

No. Phase Pressure Temperature Duration Quantity Remarks

[kPa] [°C]

1 Conditioning Vacuum 5,3 (+/-1,5) Not specified Max:1.– 4. 12 min 5

5.– 7. 10 min
2 Holding Phase Vacuum 5,3 (+/-1,5) Not specified 15 s 6

3 Conditioning Pressure 47,3 (+/-1,5) Not specified Max: 10 min 8

4 Holding Phase Pressure 47,3 (+/-1,5) Not specified 15 s 5

5 Conditioning 7. Vacuum 15,0 (+/-1,5) Not specified Max:10 min 1

6 Conditioning 8. + 9. 44,0 (+/-1,5) Not specified Max:10 min 2

Vacuum
7 Holding Phase 7. – 8. 47,3 (+/-1,5) Not specified 90 s 3
Pressure
8 Holding Phase Pressure 47.3 (+/-1,5) Not specified 15s 1 Directly
9. before start
holding time
9 Sterilization 47,3 (+/-1,5) 78,4 (+4/-0) 10 min 1

10 Desorption Vacuum 7,0 (+/-1,5) Not specified Max: 10 min 15

(upon start of the first
vacuum phase a pressure
decrease in the vaporizer
takes place)
11 Holding Phase Vacuum 7,0 (+/-1,5) Not specified 15 s 15

12 Desorption Pressure 45,5 (+/-1,5) Typically: >76 Max: 10 min 15

13 Holding Phase Pressure 45,5 (+/-1,5) Typically: >76 15 s 15

14 Vacuum Drying 2 (+2/-1,5) Not specified 10 min 1

15 Flushing Pressure 74 resp. p0 Not specified Max: 10 min 5

=101,3 (+/-1,5)
16 Flushing Vacuum 7 (+/-1,5) Not specified Max: 10 min 5

17 Ventilation p0 =101,3 Not specified 80 s 1

(80,0-108,0)
18 Post Ventilation Vacuum 7 (+/-1,5) Not specified Max: 10 min Every 30
min

19 Post Ventilation Pressure p0 =101,3 Not specified Max: 10 min - Every 30

(80,0-108,0) min
- Temperature Chamber 79°C +/-5°C Temp.> 82ºC during
Wall during Program Run more than 2 min. or
<74º-C during more
than 3 min

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Switchpoints for the Vacuum Test

No. Phase Pressure Temperature Duration Quantity Remarks

[kPa] [°C]
1 Vacuum p1 = 5,3 Not specified Max: 8 min 1
(+/-1,5)

2 Equilibration p1 to p2: 10 Not specified 5 min 1

Time (+5/-2)
3 Test Time p2 to p3 : 10 Not specified 10 min 1
(+5/-2)
4 Ventilation p0 =101,3 Not specified 80 s 1
(80,0-108,0)

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20. FORMALDEHYDE EXPOSITION SPECIFICATIONS 130 LF

1. Identification of significant sources for inhalative exposition Figure 1 shows schematically how the
sterilization solution runs through a process in the MATACHANA LTSF-sterilizer. Since the feeding
system is hermetically closed, there are, besides leakages due to deficiencies from this hermeticity,
only two sources for inhalative exposition: the chamber door that is opened after end of process
(short time evaporation of residual amounts) and the waste air of the vacuum pump system during
the entire process.

2% formaldehyde

Inner tank Only after the end of

Sterilization chamber the cycle

Pass through evaporator

Aireation
Door

Water mains intake

Water ring vacuum pump

Drain

Pump for water reservoir

Fig.1: Flow of the formaldehyde during the ‚LTSF-process in the 130LF

The exposition caused during the door opening when removing the sterilized material is limited by
the quantity of the load, as well as the residus allowed in the material (EN 14180, chapter 6.2), which
is confirmed by qualification tests (type tests) within the range of the conformity assessment with the
EC Medical Device Directive 93/42/EEC. Thus the emission to the environment is only released during
a short time (max. 10 min per cycle, 2 – 5 cycles/day). According to the tests carried out, the maximum
peak short time values are between 0,090 and 0,050 mg/m³ (measurement values from different
analyses since 1997).

Thus, evaporation of formaldehyde from the pump operating water remains for estimation as
substantial source for inhalative exposition due to the LTSF procedure.

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2. Relevant amounts of material and process data for quantitative evaluation
Knowledge about entry amounts and their chronological progress during the process is required
in order to estimate the maxiumum release of FA to the environment by evaporation from the pump
operating water.

In 2005 the external laboratory TÜV Nord Umweltschutz took and analized samples of the pump
operating water during a 60°C standard process (small load) at relevant process steps.

Formaldehyde concentration in waste water

Cycle diagram with full load

Conditioning phase Holding time Desorption phase Drying Aireation

Fig. 2: Synchronized illustration of the process and the formaldehyde concentration in the waste water

The measurements show that the waste water charge rises strongly at the beginning of the
process, i.e. in the conditioning phase. During the holding time it remains constant to a large extent,
and decreases again during the desorption phase (somewhat slower), so that after approximately 2/3
of the desorption phase there is hardly another entry. The measured average value over the entire
cycle (145 min) is approx. 150mg/L in the 60°C-Programm, the temporally weighted average value
during the relevant phases (0-100 min) amounts to 166 mg/L.
In order to be able to include also different programs and other loading quantities into the
evaluation, the relevant consumption of formaldehyde sterilizing solution and pump operating water
were also measured under these conditions and the total entry into the pump operating water was
calculated.

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Table 1: Consumption data LTSF-cycle (example)

Program Load Consumption Process Water Formal-

sterilization duration consump- dehyde
solution 2% until end of tion until entry into
Formaldehyde desorption end of the pump
desorption operating
water
60°C empty chamber 800 mL 117 min 91 L 176 mg/L
part load 1000 mL 127 min 117 L 171 mg/L
full load 1250 mL 170 min 152 L 164 mg/L
78°C empty chamber 750 mL 68 min 63 L 238 mg/L
part load 900 mL 76 min 81 L 222 mg/L
full load 1400 mL 119 min 120 L 233 mg/L

The results show increasing consumption of Formaldehyde sterilizing solution and pump operating
water as well as longer cycle times when measured with load. These data show that process times
and consumption (pump operating water, Formaldehyde solution) are increasing with the load
collective and proportional until the end of the desorption phase, thus the Formaldehyde concentration
in the pump operating water is only slightly dependant on the load (however not on the temperature).
For the values in the last column of consumption data no derivatives are considered as emission into
the environment yet. The value calculated there for 60°C, however is well confirmed by the
measurements of the TÜV Nord (small load: approx. 172 vs. 166 mg/L).

3. Calculation model for maximal exposition during operation

The system is completely closed except for the drain of the condensate – air mixture via the pump into
the pump operating water tank (see fig. 1, leakage neglected). Therefore the possible emission into
the environment can be calculated from the measured consumption data of the table (under
consideration of logical assumptions) and the maximum Formaldehyde entry into the pump operating
water. Following values and considerations have to be taken into account:
1. (Formaldehyde containing) air can escape into the environment via the retaining valve, the
(Formaldehyde containing) water is drained with a hose via a spillway directly into a gully
2. The temperature of the pump operating water is thermostatically limited to 32°C. If exceeded
cold fresh water is added until 25°C are reached.
3. During pump operation the pump operating water is is circulated permanently with large flow in
the small pump water circulation, so that physical conditions and concentrations are
homogeneous in this subsystem.
4. During the beginning of the conditioning phase (same in all programs) the chamber volume
(145 liters) is pumped from 1000 to 50 mbar by fractionation. Then (during holding time) and
during the desorption phase no more non-condensable gases are pumped. This takes place
again during the air flushing phase (the last 5 fractionations from 70 to 740 mbar).The total gas
volume discharged through the pump is approx. (converted to normal conditions)

145 L x 950 mbar + 5 x 145 L x (740-70) mbar = 623,5 bar.L,

i. e. approx. 630 standard liter air, that are released into the environment via the discharge valve.

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4. Example calculation for 60°C, full load
At quasi-stationary equilibrium conditions e.g. totally 25 g Formaldehyde (1.250 ml x 2% at 60°, full
load) immersed into 170 L vacuum pump operating water (resulting in a mean FA content of 25/170 =
ca. 147 mg/L), at 27 to 30°C by evaporation can dissipate into 630 NL of ambient air such amount of
Formaldehyde which results from establishment of thermodynamic equilibrium concentrations at these
conditions.

According to measurement results from existing literature, there is in the thermodynamic

equilibrium at 35°C and 1,09 g/L in the liquid phase an absolute content of 0,27 mg/L in the gas phase
above the solution. For 30°C the values can be derived as follows: 1,0 g/L (liquid.) a value of 0,16
mg/L (gas.). At 147 mg/L the result is respectively 147 x 0,16 = 23,5 µg/L (gas.), which are to be found
in 630 NL air. From this, the total amount of FA emitted into air can be calculated: 23,5 x 630 = 14,82
mg, which distributes into the work area.

In case of supposed evenly distribution of this exposition in the work place with room
measurement of 35 m² required according to DIN 58948 (see Ch. 8.1) the resulting charge is 0,423
mg/m³. In case of conservative calculation with a supposed “worst case“ single room air exchange
every hour (recommended acc. to 8.1 are 6/h) and a process duration of 3,17 h (190 min) this value is
further reduced to 0,423/3,17 = 0,133 mg/m³ (0,11 ppm).
In case of minimum air renewal of 100 m³/h this results under these conditions in a charge of
14,82 mg /(3,17h x 100 m³/h) = 0,047 mg/m³ (0,038 ppm) independant form the room dimensions.
This value has to be compared with the average values of the work place obtained by TÜV Nord,
which resulted in values between 0,034 and 0,044 mg/m³ (0,027 – 0,035 ppm). The conformance is
significantly good.

An intermediate result is extremely good and should be mentioned here: With an entry of 25 g
formaldehyde into the process there are only 14,8 mg of gas (mostly bound to water vapour)
discharged into the environment. This corresponds to an amount of only 0,06%. The rest is discharged
with the waste water. This behavior can be explained by the high bonding affinity of formaldehyde to
water and it´s facilitation due to the process.

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5. Overview of all results
Based on consumption data of table 1, the mean values of room-air charge for all sterilization
temperatures and all loads have been calculated using the same scheme. The are listed in the table
below:

Program load Cycle average value of rel. amount of

formaldehyde room charge formaldehyde
emission to room
air
60°C-program empty 0,066 mg/m³ 0,05 ppm 0,094 %
chamber
part load 0,061 mg/m³ 0,05 ppm 0,075 %
full load 0,047 mg/m³ 0,04 ppm 0,059 %
78°C-program empty 0,126 mg/m³ 0,10 ppm 0,123 %
chamber
part load 0,111 mg/m³ 0,09 ppm 0,099 %
full load 0,087 mg/m³ 0,07 ppm 0,072 %

It is recognizable that the values in the 78°C program are approx. twice as high as the as the values in
the 60°C program. There are no work place analyses for the 78°C program available, but according to
the respective results of the 60°C-program in the practice, real mesurement results always under 0,1
ppm could be expected.

For all cases, calculated from the measurement values with load is the relative amount of
formaldehyde that is discharged into the work place compared to the total entry into the process
always smaller than 0,1%, e. g. more than 99,9% of the added formaldehyde are discharged via
waste water and thus do not enter the work place as inhalative or dermal charge.

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21. CHARGE DOCUMENTATION

1) Charge printer (optional)

The following information is printed in clear text:

· device no.
· date
· program description
· total cycle number (total charges)
· program parameters (nominal values)
· time of program start
· pressure and temperature indication with time
· time of program end
· operating time (process duration)
· if necessary failure messages and indications referring to failure causes

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a) 60°C-Program: sample of a printout of the integrated printer

********
*******
******
*****
**** quantity of FA that has been consumed dur-
FA-consump: 15,6g ing the batch
Op. time: 186 Min.
fault-free
Process sequence time of process end, if necessary failure
10:07 Cycle complete messages and indications referring to failure
causes and/or indication "Process sequence
Number of stages: 5
fault free", cycle duration
----------------- Flushing-----------------
09:56 E. Drying 2.3 description of program phase (drying) indi -
09:46 S. Drying 7.0 cating pressure and time of start and end of
09:45 25. Pressure 21.2 the phase
08:55 1. Pressure 21.2

08:53 1. Vacuum 7.0

description of the program phase (desorp-
Time Phase kPa
tion) indicating the pressure during the
Number of stages: 25
individual phases and the respective time
-------------- Desorption----------------
08:51 End holding
62.3 °C 21.4
07:47 Start holding
--------------------------------------------- description of the phase (holding) indicating
07:47 17. Pressure 21.8 pressure and temperature within the phase
07:46 17. Vacuum 18.8 giving the start and end of the respective
phase.
07:45 16. Pressure 21.8
07:11 3. Vacuum 5.2

07:10 2. Pressure 21.1

07:05 2. Vacuum 5.3
07:04 1. Pressure 21.2 description of the phase (conditioning)
07:02 1. Vacuum 5.2 indicating the pressure within the phase
Time Phase kPa and the respective time
Number of stages : 15
----------- Conditioning------------ time of cycle start
07:01 Cycle start
++++++++++++++++++++++++
Holding Time: 60 Min
Pressure: 21.2 kPa
Temperature: 60 °C nominal parameters of the selected
PROGRAM SETTINGS program
-------------------------------------------
Operator: 0
Batch number: 38 operator no. batch no., selected pro-
Program: 60 °C gram, date, manufacturing no.
Date: 21.06.02
Manufact. no.: 94424
-------------------------------------------
LTSF - Sterilization 130LF
Manufacturer

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b) 78°C-Program: sample of a printout of the integrated printer

MATACHANA
*******
******
*****
****
FA-consumption: 15,6g quantity of FA that has been consumed dur-
Op. time: 107 Min. ing the batch
fault-free
Process sequence time of process end, if necessary failure
08:48 Cycle complete messages and indications referring to
Number of stages: 5 failure causes and/or indication "Process
----------------- Flushing----------------- sequence fault-free", cycle duration
08:37 E. Drying 1.5
08:27 S. Drying 7.0 description of program phase (drying) indi
08:25 15. Pressure 46.3 - cating pressure and time of start and end
07:35 1. Pressure 46.3 of the phase

07:33 1. Vacuum 7.0

Time Phase kPa
Number of stages: 15 description of the program phase (desorp-
-------------- Desorption---------------- tion) indicating the pressure during the
07:31 End holding individual phases and the respective time
79.3 °C 47.3
07:16 Start holding
---------------------------------------------
07:16 9. Pressure 47.3 description of the phase (holding) indicating
07:16 9. Vacuum 43.9 pressure and temperature within the phase
07:15 8. Pressure 47.3 giving the at start and end of the respective
07:11 3. Vacuum 5.2 phase.

07:10 2. Pressure 47.3

07:05 2. Vacuum 5.3
07:04 1. Pressure 47.3
description of the phase (conditioning) indi-
07:02 1. Vacuum 5.2 cating the pressure within the phase and the
Time Phase kPa respective time
Number of stages : 7
-----------Conditioning------------
07:01 Cycle start time of cycle start
++++++++++++++++++++++++
Holding time: 15 Min
Pressure : 47.3 kPa
Temperature: 78 °C
PROGRAM SETTINGS nominal parameters of the selected
------------------------------------------- program
Operator : 0
Batch no. : 38
Program: 78 °C operator no. batch no., selected
program, date, manufacturing no.
Date: 21.06.02
Manufact. no.: 94424
-------------------------------------------
LTSF- STERILIZATION - 130 LF Manufacturer

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c) Program with errors: printout example

ANTONIO MATACHANA
*******
******
******
***
Op. Time: 186 Min.

CAUTION
Program sequence
FAULTY!
Material classed as

UNSTERILE cycle non completed

10:07 Cycle complete materiel unsterile
Number of stages: 5
----------------- Flushing -----------------
09:45 25. Pressure 20.7
09:44 25. Vacuum 6.9
09:43 24. Pressure 20.7 FAULT
** FAULT***
B039/2: 0.0 °C
09:43 TS Chamber 2
** FAULT***
09:42 24. Vacuum 6.9
09:41 23. Pressure 20.6
09:40 23. Vacuum 7.0

07:02 1. Vacuum 5.2

Time Phase kPa
Number of stages : 15
-----------Conditioning------------ time of cycle start

07:01 Cycle start

++++++++++++++++++++++++
nominal parameters of the selected
Holding time: 30 Min
program
Pressure : 21.8 kPa
Temperature: 60 °C
PROGRAM SETTINGS
-------------------------------------------
Operator : 0 operator no. batch no., selected pro-
Batch no. : 38 gram, date, manufacturing no.
Program : 60 °C
Date : 21.06.02
Manufact. no.: 94424
------------------------------------------- Manufacturer
Sterilizer LTSF
ANTONIO MATACHANA S.A.

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d) Vacuum test: sample of a printout of the integrated printer

********
*******
******
*****
**** time end of test, cycle duration and
message " Test passed", if necessary
Test passed message "Test not passed" in case of
Op. time: 17 Min. failures
09:51 Cycle complete
Test value 2: 8.2 description of program phase indicat-
Test value 1: 7.9 ing the pressure during the respective
09:50 End test 8.2 phases, time and test values
09:40 Start test 7.9
09:35 Equilibrat. 5.2
Time Phase kPa
time of cycle start
--------------------------------------------
09:34 Cycle start +++++++++++
nominal parameters of the selected
+++++++++++++
program
Test pressure: 5.3 kPa
Test time : 10.0 Min.
PROGRAM SETTINGS
------------------------------------------ operator no. batch no., selected
- program, date, manufacturing no.
Operator : 0
Batch no. : 38
Program : VT
Date : 21.06.02
Manufacturer
Manufact. no.: 94424
------------------------------------------
- ANTONIO MATACHANA

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 2) Graphic Recorder

a) 60°C-Program: sample printout of the integrated graphic recorder

Indication of cycle end with

time (ok if cycle was error- Indication of date,
free) current time and cur-
rent temperature.
Indication of scale
gradations, color
and line feed for the
respective channel
(here CH2)

Time Axis

Indication of time, pres-

sure and temperature at
the end of the holding
time (delayed printout)

pressure curve
(green)

Indication of time,
pressure and tem-
perature at start of
holding time
Temperature (delayed printout)
curve (red)

Time, Batch-no.,
selected program,
date, manufact. no.
Matachana

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 b) 78°C-Program: sample printout of the integrated graphic recorder

Indication of
cycle end with
Indication of date,
current time and cur- time (ok if cycle
rent temperature. was error-free)
Indication of scale
gradations, color
and line feed for the
respective channel
(here CH2)

Indication of time,
pressure and tem-
perature at start
and the end of the Time, Batch-no.,
holding time selected program,
(delayed printout) date, manufact. no.

Matachana

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130lf_21_01_00_en
Batch Record 130 LF

Program: ___________________ Batch: _______________

Load:_____________________________________________________________

__________________________________________________________________

Stick in batch printout of graphic recorder here

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 Stick in batch printout of batch printer here, if available

Process procedure checked, batch released

yes ( ) no ( ); indicator ok ( ) not ok ( )

Date: _____________ Signature: ___________________

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