EURO--FORMOMAT

Daily putting into service press

Carry out described maintenance

Press mains switch The program runs automatically until Degassing

D Check the forced aeration stage

The chamber is evacuated and aerated again.

press

The program runs automatically until END

Operation of the system D Open chamber door -- immediately

remove the sterilized items

Press the required program D Close the chamber door

preselection button
press – acknowledge unloading
D Flasche Place the agent
receptacle containing a 2%
formaldehyde solution in the Release the sterilized goods, if
supply cabinet and close it. D the batch documentation

D Kanister Place the agent is O.K.

receptacle containing distilled D Betriebsmittelbehälter/--flaschen

water in the supply cabinet and the receptacles are completely

Operating Manual

close it. empty

D Wait for heating up D the packaging is O.K.

D Open the chamber door on the

loading side.
D Enter the goods to be sterilized, do
Switching off
not overload
D Close the chamber door Switch off the mains switch to
switch off of the device.

010021527-- 71310 GB /01.04

.

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

2
 Instructions for Use

Gas Sterilizer
Euro--Formomat 349--2

Order number:
Production number:
User: VN

Your MMM--
Customer Service: Manufacturer:
MMM-- Customer Service Customer Service Export MMM Münchener Medizin
Export Mechanik GmbH
Hauptstraße 2 Hauptstraße 2 Semmelweisstraße 6
D--92549 Stadlern / Opf. D--92549 Stadlern / Opf. D--82152 Planegg

Phone: ++49 / 9674 / 80396 Tel.: 09674 / 80--0 Tel.: 089 / 89918--0
Fax: ++49 / 9674 / 80-- 318 Fax: 09674 / 80--318 Fax: 089 / 89918--118

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

.
The Euro--Formomat instructions apply the following sterilizer types:

Gas Sterilizer Euro--Formomat 349

Legend
of the symbols used in these systems:

Attention! Must be observed with special care, because otherwise there is a risk of injuries.

Important! Observe this information, because otherwise a proper function of the system is not
ensured.

D List

To be implemented by operator

Key to be pressed by operator

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

1
2
 Contents
1 General System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 Display and Operating Elements . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.1 Operator and loading side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.1.1 Membrane keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.1.2 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.1.3 Supply cabinet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.2 Unloading side (on two--door models) . . . . . . . . . . . . . . . . . . . . . . 9
3.3 Info bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4 Gas sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.1 Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.1.1 Formaldehyde solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.1.2 Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.2 Application of the Gas Sterilizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.3 Goods to be sterilized . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.3.1 Loading of the Sterilization Chamber . . . . . . . . . . . . . . . . . . . . . . . . 12
4.3.2 Aeration (Degassing) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.3.3 Shelf Life of packaged gas--sterilized items . . . . . . . . . . . . . . . . . . . . 13
4.4 Legal Provisions, Standards and Technical Rules . . . . . . . . . . . . . . . 14
4.5 Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.5.1 Vacuum test program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.5.2 Formaldehyde Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5 Operation of the unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1 Daily putting into service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.2 Program selection menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.2.1 After switching the unit on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.2.2 Ready for operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.2.3 Display of measured values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.2.4 Program start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.3 Operation of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.4 Batch printer and printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.5 Switching off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
6 Operating Malfunctions
System Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
6.1 Operator’s Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
6.2 Safety devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
6.2.1 Safety devices on door lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
6.2.2 Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
6.2.3 Program stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
6.2.4 Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
6.2.5 Heating mat temperature too low / too high . . . . . . . . . . . . . . . . . . . 38
6.2.6 Pressure transducer monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
6.2.7 Cycle time monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.2.8 CAN bus monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

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 6.2.9 Motor protection switch vacuum pump . . . . . . . . . . . . . . . . . . . . . . . 39
6.3 Residual Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.3.1 Worker’s protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.3.2 Patient’s Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.3.2.1 Sterilization Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.3.2.2 Residues on the sterilized goods . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

7 Maintenance, Cleaning and Care . . . . . . . . . . . . . . . . . . . . . . . . . . 41

7.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
7.2 Maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
7.3 Interior walls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.4 External care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.5 Interior Space of the unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.6 Servicing, Obligatory Regular Inspection . . . . . . . . . . . . . . . . . . . . . 42
7.7 Monitoring of efficiency of the sterilization agent . . . . . . . . . . . . . . . 43
7.8 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

8 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Annex
Equipment, consumables
Spareparts
Wiring system diagram

4
1 General System Description

The Euro--Formomat system is a fully automatic gas sterilizer that meets the re-
quirements of TRGS 513. This system uses a negative pressure method.

German code requirements governing hazardous substance (GefStoffV sec-

Attention
tion 25) and the technical regulations TRGS 513 make it mandatory that gas
sterilizers are operated only by personnel certified capable.

Personnel responsible for operating gas sterilizers must be trained by the ma-
nufacturer no later than when the system is handed over and made conversant
with the requirements of these Operating Instructions. Personnel know--how
in this respect is to be refreshed from time to time.
' Chap. 6.1

Depending on the installation conditions, the Euro--Formomat is available as sin-

gle--door or two--door unit. The sterilization chamber is electrically heated and
heat insulated.

The sterilization chamber is closed by one (two) laterally swinging hinged door(s)
with quick--action lock. During program run, the sterilizing chamber cannot be ope-
ned. The safety lock mechanism is effective also in case of a complete failure of
services.

Program run is fully automatic. For safety reasons no means of manual interference
is provided.

Loading and unloading of the sterilizer is done manually.

In compliance with general technical regulations, the pressure vessel is designed

for an operating pressure of 0 to 1 bar absolute.

The electrical equipment meets the DIN/ VDE regulations currently valid.

Upon termination of its life time, the Euro--Formomat can be correctly removed by
MMM. Please contact you service agency.

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

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2 Technical Data

Operator: VN

Designation: Euro--Formomat 349--2

Order No.:
Year of delivery: 2004
Year of manufacture: 2004

Serial No.:

Max. permiss. operating temperature: 75 ˚C

Operating overpressure 0 to 1 barabs

Capacity of the sterilization chamber. 110 dm3

Connected load

Operating voltage Main circuit(s):

230/400 volt three--phase current

Power: 6,5 kVA

Fuse protection: 3 x 16 A

Type of current: 3/N/PE AC 400V

A weighted noise level LWA= 69 dB
LWA, max= 87dB

Nominal frequency: 50 Hz

For system connections see “Technical Data Sheet” or “Installation Drawing”.

6
3 Display and Operating Elements

3.1 Operator and loading side

Supply cabinet Display

1 2 3 4 5 C
6 7 8 9 0

Münchener Medizin Mechanik GmbH Euro--Selectomat

Membrane keyboard
Mains switch
Key switch
Program stop
Switch

Thermal plotter

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

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 Display and Operating Eelements
3.1.1 Membrane keyboard

Description of the keys:

D -- Select a program

D , Selection within the menus

D Starts the selected program

D , Movement in entry mask

D Mark a program in program

sequence menu

D Acknowledgement or jump to a lower menu level

C
D Exit or jump back

Reset
D Terminate a program

End
D Terminate aeration

8
 Display and Operating Eelements
3.1.2 Display

The display has four lines. The display shows:

D the selected program
D the cycle stages or current values

D malfunction messages
D service information and service application

3.1.3 Supply cabinet

Accomodating the receptacles filled with distilled water and formaldehyde solution
(according to German Standard DIN 58 948/15). The content is sufficient for one
batch only.

Couple the hose of the canister to the hose connection provided at the supply cabi-
net.

The bottles are closed with a rubber plug and flanged cap made of aluminium. They
are placed upside down onto the needles and punctured. Make sure, that the alumi-
nium bracket in the pushing--through section that protects the rubber plug is remo-
ved before the bottle is punctured. Lock the door of the supply cabinet after the
bottle is positioned on the holding device.

3.2 Unloading side (on two--door models)

Program stop switch

RESET

END

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

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 Display and Operating Eelements

3.3 Info bar

red yellow blue white green

1
Indicators
Teleclock (optional) sterilizer number

The Info bar is equipped with five indicator lamps and a Teleclock for the display of the remaining time of
the sterilization process for optimised timing of the sterilizer loading. If several sterilizers are installed in
the same area, each of them can be identified individually by a number that is to be attached to the sterilizer.
The colour indicator lamps correspond to prEN14180.

Colour Naming On Off Flashing

Green Ready for ope- As soon as the ma- Upon actuation of the
ration (MMM chine is ready for start switch
definition) operation
Blue Door(s) locked Door is Door is not locked and
(prEN14180, locked can be opened
6.1.3 a)
Yellow At work Upon actuation of Immediately after the After the start but-
(prEN14180, the start switch in goods have been remo- ton has been pressed
6.1.3.b) standard programs ved, the door has been in test programs
(P1--P10) closed and the RESET-- (P11, P12, P13)
button has been pressed
in programs P1--P11.
As soon as the released
door has been opened
in P12 and P13 (see
last paragraph 6.1.3
prEN14180)
White Cycle End During the stages As soon as the goods
(prEN14180, Degassing, Evacua- have been removed, the
6.1.3.c) tion prior to door door has been locked
opening and Take and the RESET button
out has been pressed in
in standard pro- program P1--P11. As
grams (P1--P10) soon as the released
door has been opened
in P12 and P13 (see
last paragraph 6.1.3
prEN14180)
Red Error Error on the machi- No error
(prEN14180, ne
6.1.3.d)

10
4 Gas sterilization

4.1 Services

4.1.1 Formaldehyde solution

The agent is a 2 % formaldehyde solution, made from a 37 – 40 % formalin solution.

This basic solution contains 10 % methanol as stabiliser. Under normal ambient
conditions, the solution can be stored at a temperature of 10°C to 25°C.

At room temperature formaldehyde is a colourless, pungent gas which is highly irri-

tant to mucous membranes. According to German TRGS 900 dated October 2003,
its maximum threshold limit value (MAC value -- maximum allowable concentra-
tion) is 0.5 ml/m3 (ppm) or. 0.6 mg/m3.

The formaldehyde solution can be purchased from our cooperation partner (see an-
nex.

4.1.2 Water

The agent must have aqua dest. quality and can be purchased from our cooperation
partner (see annex).

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

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Gas sterilization

4.2 Application of the Gas Sterilizer

With working temperatures at 75, 60 and 55°C, the sterilizer is the optimum system
to process heat--sensitive items without damaging them. This would not be possi-
ble with conventional steam sterilization methods.

However, due to the higher risk involved, gas sterilization must be restricted to
items which cannot be subjected to steam sterilization. According to GefStoffV §6
(German ordinance concerning hazardous material), it is mandatory to replace
heat--sensitive items by items lending themselves to the conventional methods of
sterilization where possible.

4.3 Goods to be sterilized

4.3.1 Loading of the Sterilization Chamber

During operation of the gas sterilizer condensate may be produced during the diffe-
rent phases of the program which must be drained off. This is why, pans, vessels
and the like must be located upright in the loading basket, with their opening direc-
ted downwards. For the same reason wire baskets open on all sides must be used
for loading. The basket may be relatively wide--meshed as only wrapped items are
allowed for processing.

The correct loading pattern depends on the goods to be sterilized. Thus, metal cove-
red plastic items should not be placed in the basket horizontally but vertically. Ho-
ses should be arranged so as to have both ends hanging downwards, preventing
moisture from accumulating in bends. Wrapped items (packs) should be placed
vertically in the basket if possible.

It is also necessary to leave some space between the packs; packs should not be
compressed. The whole load should be loosely arranged.

To prevent sterilizing gases from being heavily absorbed by the wrapping material,
the use of cotton or linen should be avoided.

For technical reasons the chamber should not be loaded by more than 4/5ths of its
useable space. Do not allow items to contact the sterilization chamber wall.

12
Gas sterilization
4.3.2 Aeration (Degassing)

The duration of desorption required depends on a multitude of factors,

in particular on the following:

D material composition of the items sterilized

D method of sterilization
D nature of the packaging

D packing material

D intended use

Notes to the limit values concerning residual formaldehyde on medical devices and
their intended use can be drawn from EN 14180 annex E and D.

Storage of Items sterilized with Formaldehyde

The packaging material may have absorbed formaldehyde, which is given off to the
surrounding air. Make sure, that suitable ventilation is provided in the storage room
or sterile goods store to ensure that the stipulated threshold limit value is not excee-
ded.

4.3.3 Shelf Life of packaged gas--sterilized items

The allowable shelf life is mainly dictated by the storage conditions. German Stan-
dard DIN 58 953 part 7 stipulates the following

Shelf life
Packaging of sterilized Type of packaging unprotected storage protected storage
items (according to 4.3a in DIN (according to 4.3b in DIN
58 953--8: 1993--02) 58953--8 : 1993--02)
paper bags according to E sterilized items in For immediate usage 6 months 1)
DIN EN 868--4; primary or secondary only. Avoid long--term
transparent bags and packagings storage.
tunnel bags of a paper and
plastic composite which
are self--sealing or Sterile goods packaging 5 years,
hot--sealed according to E for storage not opened or if no other expiry date is set by the manufacturer
DIN EN 686--5; opened and closed again.
other similar packagings
1) For practical and economical reasons, it has not proven to be recommendable to exceed the packaging’s
shelf life.

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Gas sterilization

4.4 Legal Provisions, Standards and Techni-

cal Rules

GefStoffV Hazardous Substances Directive

BIschG Federal German Emission Control Law

TA--Luft Technical Rules for Clean Air

TRGS Technical Rules and Regulations governing

Hazardous Substances

UVV Accident Prevention Regulations

DIN 58 948, part 1 Sterilization

Gas sterilizers
Terms

DIN 58 948, part 7 Sterilization

Gas sterilizers
Constructional requirements and services for
large ethylene oxide and formaldehyde sterilizers

DIN EN 14180 ”Sterilizers for medical purposes -- low tempera

ture steam and formaldehyde sterilizers --
Requirements and testing

DIN 58 948, part 14 Sterilization

Gas sterilizers
Biological indicators for efficiency testing
of formaldehyde gas sterilizers

DIN 58 948, part 15 Sterilization

Gas sterilizers
Small formaldehyde sterilizers
Equipment requirements, services, constructional
requirements

DIN 58 948, part 16 Sterilization

Gas sterilizers
Operation of formaldehyde gas sterilizers

DIN EN 866--5 ”Biological systems for testing

sterilizers and sterilization methods.
Part 5: spcial systems for the use of sterilizers
working with low temperature, steam and
formaldehyde”

14
Gas sterilization
EN61010--1 or Safety regulations governing electrical
measuring,
EN61010--2--042 controlling and regulating devices and laboratory
units

EN60079--10 Regulation goverining electrical installations in

hazardous locations (ElexV)

EMC -- directive 89/336 / EEC

Medical device directive 93/42 / EEC

Medical Device Act (MDD)

MPBetribV – Medical Devices Operator Ordinance

Electromagnetic compatibility
The Euro--Formomat sterilizer meets the requirements of the following standards:
EN 55011:1998 + A1:1999 , EN 60601--1--2:2001
EN 61000--3--2:2000, EN 61000--3--3:1995 + A1:2001

4.5 Programs

The sterilizer is equipped with following automatic programs.

D Program 1:

Formaldehyde – steam program for sterilization of heat--sensitive items under

negative pressure at a sterilization temperature of approx. 55°C
D Program 2:

Formaldehyde – steam program for sterilization of heat--sensitive items under

negative pressure at a sterilization temperature of approx. 60°C
D Program 3:

Formaldehyde – steam program for sterilization of heat--sensitive items under

negative pressure at a sterilization temperature of approx. 75°C
D Separate Vacuum test program checking the chamber for tightness;

D Service program „Test cycle” for maintenance and validation allowing for

more possibilities to intervene

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

15
Gas sterilization
4.5.1 Vacuum test program

Air removal from the sterilization chamber and particularly from the items to be
sterilized is a mandatory requirement for successful sterilization, otherwise „air
pockets“ will be formed within the load to be sterilized. These air pockets prevent
the necessary steam access to warm up and moisten the items to be sterilized, thus
preventing proper conditioning for reliable gas sterilization.

Optimum air removal is achieved by repeated evacuation and steam injection with
the sterilizer operating vacuum--tight.

The program control runs a vacuum test to check the necessary vacuum tightness,
with which the chamber and its connected pipes are tested for a possible leakage.
The vacuum test is carried out in two stages

The sterilization chamber is first evacuated to a pressure of pabs = 50 mbar. The eva-
cuation is followed by a test time of 5 minutes during which the pressure initially
induced should not increase by more than 3 mbar per minute. During the second
stage of the vacuum test the chamber is ventilated to pabs = 800 mbar. The evacua-
tion is followed by a test time of 2 minutes during which the pressure initially indu-
ced should not increase by more than 3 mbar per minute.

Vacuum test passed

If the pressure does not increase by more than the predefined values during the two
test phases, the test has been passed.

Vacuum test failed

If the pressure increases by more than the predefined values during one of the two
test phases, the test has been failed. This is indicated by the message Vacuum test
failed and by the red signal lamp.

The sterilization chamber is once again evacuated and aerated. After a short holding
time, the door on the loading side can be opened.

Should the leakage be a false fault, produced by residual moisture in the steriliza-
tion chamber resulting from a previous sterilization cycle, wipe dry the inside of
the chamber with a cloth and leave the door open for some time with the system
still being warmed up.

16
Gas sterilization
4.5.2 Formaldehyde Programs

After program start the cycle will be carried out automatically, each phase being
indicated on the display.

Vacuum test
This cycle stage is carried out only, if it is selected in the menu. (optional)

Humidifying
Carried out only, if selected in the menu. (optional)

Air removal with FO

Repeated addition of a mixture of steam and formaldehyde in the chamber until the
preset pressure value is attained, alternating with evacuation of the chamber for
transport of the sterilizing agent onto the items and particularly into the narrow lu-
mens of the items to be sterilized. (pulsing with a mixture of formaldehyde and
steam)

Sterilizing
The programmed sterilization time is running.

Steam flushing
Repeated flushing with steam, alternating with the evacuation of the chamber to re-
move the formaldehyde.

Drying
Repeated flushing with air, alternating with the evacuation of the chamber. The ae-
ration phase serves to dry the sterilized goods and to further remove the residual
formaldehyde from the goods.

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

17
Gas sterilization
Forced aeration
This stage automatically follows the stage DRYING and comprises the following
repeated program sequence:

Evacuation of the chamber with subsequent hold period followed by ventilation of

the chamber with subsequent hold period.

This sequence is repeated until a programmed minimum aeration time of 1 hour is

over and serves to ensure the staff’s safety.

Aeration
As soon as this message appears, the END button is active. The aeration program
can then be terminated by pressing the END button.

End
By pressing the END button, the sterilization chamber is evacuated and vented once
again. After pressure compensation, the message END will be indicated. The aera-
tion program is then terminated and the door is unlocked for 2 minutes.

If the chamber door is opened during this period, the message END will disappear.
By pressing the Reset key, the unloading stage is acknowledged and the cycle re-
turns to the stage “Ready for operation” which is then displayed.

18
5 Operation of the unit

The operation of the sterilizer has to be carried out in compliance with regulations
Attention
governing the handling of hazardous substances (German GefStoffV § 15) and with
technical directions relating to hazardous substances (e.g. German TRGS 513).

Existing national regulations concerning the threshold limit value for formalde-
Attention
hyde must be observed.

According to German DIN 58948, operators must be instructed in the unit’s opera-
tion by the manufacturer, the importer or supplier and must be informed about pos-
sible risks. This instruction shall be certified and every operator must have such
a certificate.

Prior to sterilization, an indicator is to be put in every batch. The sterilized batch

Important is to be released only, if the indicator shows a satisfying result.

5.1 Daily putting into service

Carry out described maintenance

Press the power switch – switch illumination is on

Before the doors are opened for the first time, the chamber is evacuated and reventi-
lated with the chamber doors closed, thus removing any residual formaldehyde
which possibly still remains in the empty sterilization chamber from the previous
sterilization cycle.

Read--out on the display: Power out -- evacuation;

then Ready for operation .

5.2 Program selection menu

5.2.1 After switching the unit on

During switching the unit on, the following message appears on the display after
a waiting period of 1 minute.

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19
Operation of the unit

01 Universal 55
> 02 Universal 60
03 Universal 75
12 Vacuum test
The heating mats heating Heating mats are warming up, please wait

or

01 Universal 55
> 02 Universal 60
03 Universal 75
12 Vacuum test
Evaporator is heating up Evaporator is heating up, please wait

The first three lines show all programs that can be selected. The program currently
active is marked by a preceding > .

The fourth display line is reserved for status or malfunction messages.

If the machine was switched off for some time, the chamber and the evaporator must
first reach their operating temperature after switching on. This is signalled by cor-
responding messages in the status line.

Only after all components hae reached their operating temperature, is the Euro--For-
momat ready for operation.

5.2.2 Ready for operation

01 Universal 55
02 Universal 60
>
03 Universal 75
12 Vacuum test
Ready for operation

5.2.3 Display of measured values

The measured values can be displayed any time, no matter if the Euro--Formomat
is currently heating up, ready for operation or if a cycle is running.

20
Operation of the unit
Press the arrow--right--button to get to the 1. picture of the measured values.

P KmrRgln 953 mbar Display of the pressure transducer

Chamber control
P KmrRgln 952 mbar Display of the pressure transducer
Chamber recording

Press the arrow--right--button again to get to the 2. picture of the measured values:

P Verd.FO 953 mbar Display of the pressure transducer

Evaporator FO
P Verd.H2O 952 mbar Display of the pressure transducer
Evaporator H2O

Press the arrow--right--button again to get to the 3. picture of the measured values:

T KmrRgln 62,1˚C Display temperature Chamber control

T KmrRgst 62,3˚C Display of pressure transducer Chamber recording
T evaporator 94,3˚C Display temperature Evaporator

Press the arrow--right--button again to get to the 4. picture of the measured values:

T Kmr Mitte 64,1˚C Display temperature Heating mat chamber middle

T Kmr BS 64,2˚C Display temperature Heating mat chamber loading side
T Kmr ES 64,1˚C Display temperature
Heating mat chamber unloading side

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21
Operation of the unit
Press the arrow--right--button again to get to the 5. picture of the measured values:

T TürBS 65,0˚C Display temperature Heating mat door loading side

T TürES 65,1˚C Display temperature Heating mat door unloading side

Press the arrow--right--button again to get to the 6. picture of the measured values:

01:01:2002 05:02:26 Display temperature Heating mat chamber middle

Batch number 2 Display temperature Heating mat chamber loading side
Maintenance 899 Display temperature Heating mat chamber unloading side

Press the arrow--right--button again to get to the 7. picture of the measured values:

Residual time 00:20:14 Display residual time of program run

Cycle step time00:05:37 Display of the residual time of the current cycle step

Press the arrow--right--button again to get back to the program selection menu.

22
Operation of the unit
5.2.4 Program start

After a sterilization program has been started, various cycle steps are carried out one
after the other. Each cycle step consists of various cycle elements.

Cycle step Possible cycle elements

Air removal FO Evacuation, pressure increase
Sterilization --
Steam flushing Evacuation, pressure increase
Drying Evacuation, holding, pressure
increase, holding
Forced aeration Evacuation, holding, pressure
increase, holding
Aeration Evacuation, holding, pressure
increase, holding

The current cycle step is displayed in the 2. display line in alternation with the cur-
rent cycle element.

P02 Universal 60 P02 Universal 60

AIR REMOVAL 1FO 1/10 Evacuation
768 mbar 63,0˚C 768 mbar 63,0˚C

On the right side from the cycle step, the number of the current repetition and the
amount of repetitions of the cycle step are displayed.

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

23
Operation of the unit
5.3 Operation of the system

Press the desired program select button

Place the plastics bottle containing a 2% formaldehyde

solution in the supply cabinet and close it.
Per batch two receptacles of formaldehyde solution is required.

Place the agent receptacle containing distilled water in the

supply cabinet and close it.
Per batch one receptacle of distilled water is required.
Wait until heating has reached the operating temperature
Read--out on the display: Heating mat xxx too cold
As soon as the display is extinguished and the signal lamp shows Ready for opera-
tion :

Open the chamber door on the loading side – enter the

goods to be sterilized – insert the formaldehyde indicator
strip (see annex for material number)
Make sure that the goods to be sterilized are entered in the chamber only immedia-
tely before the intended start of the cycle.

Close the chamber door

Shut the chamber door and turn the sash fastener with the unit being switched on,
thus locking the chamber. Unauthorized opening is automatically prevented on pro-
gram start.

press.
The program runs automatically until Degassing
The cycle end signal lamp is on.

press to terminate the program run

24
Operation of the unit
The sterilization chamber is once again evacuated and aerated. After pressure com-
pensation, the display shows Removal ; the door is unblocked for 5 minutes.

If the chamber door is not opened during this period as initially intended , the pro-
gram will return to stage Aeration. The door(s) is (are) then locked again. This pro-
cedure is controlled such as to be continuously repeatable.

Release in compliance with worker’s protection rules TRGS 513:

Prior to the opening of the chamber door check by means of batch documentation
if the desorption phase (forced aeration) has been performed properly.

Open the chamber door on the unloading side.

Remove the sterilized items

Close the door

One--door model: The door may be closed and opened as often as necessary,when the door is closed
the aeration phase is active.

Two--door model: The door may be closed and opened as often as necessary, the opposite door being
locked however; if the door is closed the aeration phase is active.

Indicators
D white on: cycle end
D blue off: door unblocked;

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

25
Operation of the unit
Removal of the sterilized goods is terminated

Remove empty agent receptacles from the supply cabinet.

If due to a system fault residual liquids are still contained in the agent receptacles,
these have to be removed.

If agent receptacles containing formaldehyde solution are involved, you have

Attention
to wear eye protectors and safety gloves!

Close the door

Acknowledge the removal

Read--out on the display: Ready for operation

Release the sterilized goods:

D check by means of the batch documentation, if the process has been properly

performed
D check if the agent receptacles have been completely emptied

D check the indicator strip for colour change

D check the packaging for excessive moisture

Note that sterilized items must not be stored in the sterilizer when in stage Ready
Important for operation or if the machine is switched off.

26
Operation of the unit
5.4 Batch printer and printer

(accessories)

The batch printer records the course of the temperature and pressure in the chamber.

In addition, the important data of the cycle run are printed.

D Sterilizer number

D Program start

Date
Time
D Batch number
D Selected program
D Sterilization -- Start
D Sterilization -- End

In case of operating malfunctions, the message Malfunction is printed.

5.5 Switching off

Switch off the power switch – switch illumination is off

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

27
6 Operating Malfunctions
System Safety

6.1 Operator’s Safety

According to German Regulations on Hazardous Substances, section 15 and Tech-

Attention
nical Directions on Hazardous Substances (TRGS 513) gas sterilizers are to be ope-
rated only by staff certified capable.

Personnel responsible for operating gas sterilizers must be trained by the manufac-
turer no later than when the system is handed over and made conversant with the
requirements of these Operating Instructions. Personnel know--how in this respect
is to be refreshed from time to time.

The name(s) of the person(s) authorised to operate the sterilizer must be recorded
in a medical device logbook that must be kept in accordance with DIN 58.946, part
16.

In case of a change in personnel any new operator is to receive training without

delay. Additionally, the change in operating responsibility must be recorded in the
medical device log book.

The operator of the sterilizer is responsible for arranging sufficient instruction in

the operation of the sterilizer in time.

According to section 20 of the Regulations on Hazardous Substances and to TRGS

555, an internal operating manual specific to the facilities which run the sterilizer
has to be worked out by the Gas Sterilizer Engineer.

6.2 Safety devices

The gas sterilizers is equipped with all means of control and operating elements ne-
cessary to ensure processing as required for satisfactory sterilization.

MMM gas sterilization systems are designed in accordance with DIN 58 948 and
comply with the regulations of TRGS 513

The safety devices incorporated in the sterilizer are listed below. Unless stated
otherwise, faults are to be rectified by the technical staff or by the MMM service
technician.

28
 Operating Malfunctions
System Safety
Alarm Stage Alarm cause Additon Alarm text Delay
Num-- long time in
ber sec
(default)
1 Ready for System ready Machine is 0
operation ready for
operation
2 Ready for Loading door Loading door 0
operation open open
3 Ready for Unloading door Unloading door 0
operation open open
4 Program run Loading door Loading door 0
open during open during
program run program run
5 Program run Unloading door on two--door Unloading door 0
open during models only open during
program run program run
6 Every stage CAN node CAN node P10 0 (fix)
pressure does not
transducer does respond
not respond
7 Every stage CAN node CAN node P11 0 (fix)
pressure does not
transducer respond
chamber
recording does
not respond
8 Every stage Temperature CAN node T10 0 (fix)
probe chamber does not
control does respond
not respond
9 Every stage CAN node CAN node T11 0 (fix)
temperature does not
probe chamber respond
recording does
not respond
10 Every stage Error locking Error occurs, if Locking error 2
loading door the locking loading door
status of input
and output
differ
11 Every stage Error locking On two--door Locking error 2
unloading door models only, loading door
error occurs, if
the locking
status of input
and output
differ

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

29
Operating Malfunctions
System Safety
Alarm Stage Alarm cause Additon Alarm text Delay
Num-- long time in
ber sec
(default)
12 Every stage CAN bus does CAN bus does 0
not work not work
13 Ready for The key switch Actuate key 0
operation or must be switch
End actuated
14 Sterilization Temperature of Heating mat 600
program heating mat chamber
pre--selected or chamber loading side too
active loading side too cold
low
15 Sterilization Temperature of Heating mat 600
program heating mat chamber
pre--selected or chamber loading side too
active loading side too hot
high
16 Sterilization Temperature of Heating mat of 600
program heating mat chamber
pre--selected or chamber middle too cold
active middle too low
17 Sterilization Temperature of Heating mat of 600
program heating mat chamber
pre--selected or chamber middle too hot
active middle too high
18 Sterilization Temperature of Heating mat 600
program heating mat chamber
pre--selected or chamber unloading side
active unloading side too cold
too low
19 Sterilization Temperature of Heating mat 600
program heating mat chamber
pre--selected or chamber unloading side
active unloading side too hot
too high
20 Sterilization Temperature of Heating mat 600
program heating mat door loading
pre--selected or door loading side too cold
active side too low
21 Sterilization Temperature of Heating mat 600
program heating mat door loading
pre--selected or door loading side too hot
active side too high
22 Sterilization Temperature of Heating mat 600
program heating mat door unloading
pre--selected or door unloading side too cold
active side too low

30
 Operating Malfunctions
System Safety
Alarm Stage Alarm cause Additon Alarm text Delay
Num-- long time in
ber sec
(default)
23 Sterilization Temperature of Heating mat 600
program heating mat door unloading
pre--selected or door unloading side too hot
active side too high
24 Standard Door fan does Error door fan 5
programs not rotate
although
actuated.
25 Program run Cycle time of a Cycle time 0
cycle stage exceeded
exceeded and
NO program
stop
26 Program run Cycle time of a Cycle time 0
cycle stage exceeded
exceeded and during program
program stop stop
running
27 Program run Chamber No program 0
pressure control start (chamber
during program pressure
start is too high outside
or too low. tolerance band)
Program start
interrupted
28 Ready for Last vacuum Last vacuum 0
operation or test not passed: test failed:
program but
not vacuum test
29 Vacuum test Pressure This alarm Pressure 0 (fix)
waiting time increase of must have a increase
vacuum test delay time of 0. waiting time
during waiting The program stage 1 too
time stage 1 too stop bit must be high.
high set.
30 Vacuum test Pressure This alarm Pressure 0 (fix)
waiting time or increase of must have a increase
test time. vacuum test delay time of 0. waiting time
during waiting The program stage 2 too
time stage 2 too stop bit must be high.
high set.

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

31
Operating Malfunctions
System Safety
Alarm Stage Alarm cause Additon Alarm text Delay
Num-- long time in
ber sec
(default)
31 Vacuum test Pressure This alarm Pressure 0 (fix)
waiting time or increase of must have a increase test
test time. vacuum test delay time of 0. time stage 1 too
during waiting The program high.
time stage 1 too stop bit must be
high set.
32 Vacuum test Pressure This alarm Pressure 0 (fix)
waiting time or increase of must have a increase test
test time. vacuum test delay time of 0. time stage 2 too
during waiting The program high.
time stage 2 too stop bit must be
high set.
33 Program run Manual cycling Manual cycle 0
through from advance carried
one cycle stage out
into the next
carried out.
34 Program run SW internal Program 0
alarm. Program number during
interruption program
shall be carried interruption not
out but the known.
program
number is not
known.
35 Every stage Program stop Program stop 0
button has been actuated
pressed
36 Every stage CAN node CAN node P20 0 (fix)
pressure does not
transducer respond
evaporator FO
does not
respond
37 Every stage CAN node CAN node P30 0 (fix)
pressure does not
transducer respond
evaporator H2O
does not
respond
38 Every stage CAN node Info Only in case of CAN node Info 0 (fix)
bar loading side option info bar bar loading side
does not unloading side does not
respond respond

32
 Operating Malfunctions
System Safety
Alarm Stage Alarm cause Additon Alarm text Delay
Num-- long time in
ber sec
(default)
39 Every stage CAN node Info CAN node Info 0 (fix)
bar unloading bar unloading
side does not side does not
respond respond
40 Cycle element Pressure This alarm Pressure 0 (fix)
“Holding increase during must have a increase
vacuum” stage “Holding delay time of 0. “Holding
vacuum” too The program vacuum” too
high stop bit must be high
set.
41 Cycle element Pressure This alarm Pressure 0 (fix)
“Holding increase during must have a increase
pressure” stage “Holding delay time of 0. “Holding
pressure” too The program pressure” too
high stop bit must be high
set.
42 Sterilizing Difference of The program Difference of 0
temperature stop bit must be T10/T11 during
probes T10/T11 set. sterilization too
too high high
43 Sterilizing Difference of The program Difference of 0
pressure stop bit must be P10/P11 during
transducers set. sterilization too
P10/P11 too high
high
44 Sterilizing Sterilization The program Sterilization 0
temperature too stop bit must be temperature too
low set. low
45 Sterilizing Sterilization The program Sterilization 0
temperature too stop bit must be temperature too
high set. high
46 Sterilizing The chamber The program Chamber 0
pressure during stop bit must be pressure during
sterilization is set. sterilization too
unacceptably high
high
47 Standard Message, that Sterilization 0
programs sterilization is with water
done with water
instead of
formaldehyde.
48 Standard A parameter Parameter 0
program or has been saved modified
vacuum test in the control
menu.

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

33
Operating Malfunctions
System Safety
Alarm Stage Alarm cause Additon Alarm text Delay
Num-- long time in
ber sec
(default)
49 Every stage Overtempera-- Overtempera-- 2
ture of heating ture heating
mats mats
50 Every stage Motor Motor 0
protection protection
switch vacuum switch vacuum
pump pump
51 Every stage Excess Excess 5
temperature of temperature
the evaporator evaporator
52 Every stage CAN node CAN node 0
Wago does not Wago does not
respond respond
53 Every stage Buffer battery Buffer battery 5
in controller dead, data loss
dead or does in case of
not exist power failure
54 Every stage Power failure Power failure, 0
during program program
run, program interrupted
interrupted
55 Every stage Power failure Power failure, 0
during program program
run, program continued
run continued
56 Every stage CAN node CAN node 0
compact box 1 compact box 1
does not does not
respond respond
57 Every stage CAN node CAN node 0
compact box 2 compact box 2
does not does not
respond respond

34
 Operating Malfunctions
System Safety
Alarm Stage Alarm cause Additon Alarm text Delay
Num-- long time in
ber sec
(default)
58 Every stage Debug active: DEBUG 0
Under machine ACTIV
parameters -->
General, there
is a parameter
called ”Debug
option”. Every
bit of this
parameter
represents a
deactivated
alarm. Access
authorization
for
programmers
only !
59 Every stage Temperature Error T10 1,5
probe
60 Every stage Temperature Error T11 1,5
probe chamber
recording T11
defective
61 Every stage Float switch Float switch 5
signals water signals error
shortage in
evaporator
62 Every stage Pressure Pressure 5
difference difference
between P10 P10--P11 too
and P11 too high
high
63 Every stage Service counter Carry out 0
at zero maintenance
64 Ready for Heating mats Heating mats 0
operation are heating up are warming
after switching up, please wait
the machine on
65 Ready for Evaporator is Evaporator is 0
operation heating up after heating up,
switching the please wait
machine on
66 Every stage Heating mat Check heating 0
chamber mat T21
loading side is
actuated too
long

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

35
Operating Malfunctions
System Safety
Alarm Stage Alarm cause Additon Alarm text Delay
Num-- long time in
ber sec
(default)
67 Every stage Heating mat Check heating 0
chamber mat T20
middle is
actuated too
long
68 Every stage Heating mat Check heating 0
chamber mat T22
unloading side
is actuated too
long
69 Every stage Heating mat Check heating 0
door loading mat T23
side is actuated
too long
70 Every stage Heating mat Check heating 0
door unloading mat T24
side is actuated
too long
71 Every stage CAN node CAN node 0
built--in printer built--in printer
does not does not
respond respond
72 Every stage Paper of Built--in printer 0
built--in printer Paper out
almost out or
out.
73 Every stage Built--in printer Built--in printer 0
is printing is printing
74 Every stage CAN node CAN node 0
SimCon Box SimCon Box
does not does not
respond respond
75 Every stage The SimCon Waiting for 0
Box has not yet Simcon Box
responded after
switching the
machine on

36
 Operating Malfunctions
System Safety
6.2.1 Safety devices on door lock

Opening and closing of the chamber door(s) is done manually.

The doors are equipped with a cliplock that is closed and opened by means of a sash
fastener.

The program can only be started, if the sterilization chamber door(s) is (are) pro-
perly closed.

According to DIN 58 948 the doors are locked during the complete program run.
Even in case of a power failure the lock remains effective.

If a door limit switch fails to be actuated during program run the following message
appears Loading door open during program run or Unloading door open during
program run.

6.2.2 Operating conditions

Special care has been taken to incorporate the following system safety functions in
the construction:
D The whole operating cycle is carried out under subatmospheric pressure preven-

ting gas escaping from the chamber.

D Only fully automatic operation is possible thus eliminating the risk of faulty ma-

nual operation.
D The sterilization program runs after actuation of the START key only, if

-- the chamber door(s) is (are) properly closed,

-- the chamber has been sufficiently warmed up

-- the PROGRAM STOP switch has been released

-- a sufficient amount of water is provided in the evaporator – heat exchanger

6.2.3 Program stop

The red PROGRAM STOP switch is provided for emergency cases only.

With the actuation of the PROGRAM STOP key the running sterilization program
is interrupted.

If the PROGRAM STOP key is actuated after the cycle has reached the stage Aera-
tion FO, the formaldehyde is removed from the sterilization chamber by repeated
evacuation and ventilation (emergency stop program).

On two--door sterilizers the door on the unloading side remains locked.

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

37
Operating Malfunctions
System Safety
In case of an EMERGENCY SWITCH OFF during or after sterilization, sa-
Attention
fety measures protecting personnel must be observed when opening the cham-
ber!

Upon actuation of the red PROGRAM STOP switch the lock remains closed until
the switch is released. Unlocking is done with a key. The key should be accessible
to the manager of the gas sterilizer only.

The batch processed in a sterilization cycle which has been stopped by the emer-
gency stop program (during or after the phase Sterilization) must be regarded as not
sterile. This batch is to be sterilized again, once the fault has been rectified.

The program is completed in the same way as in a normal program stop.

6.2.4 Power failure

In case of a power failure before or during the sterilization stage, the program cycle
is interrupted immediately.

In case of a power failure after the sterilization stage, the program interruption is
actuated only if the power failure continues for more than 60 s or if power failures
occurs more than once.

If not, the program continues where it stopped.

6.2.5 Heating mat temperature too low / too high

The temperature distribution in the Euro--Formomat chamber and doors is effected

by 5 separately controlled heating mats. If the Euro--Formomat is switched on after
completely cooled down, it can only be started after all chamber heatings have re-
ached their predefined temperature. This usually takes about 20 – 40 minutes.

If during operation the temperature exceeds or is below its set value by 5˚ for more
than 10 minutes, the following malfunction message will appear Heating mat xx
too cold /hot.

6.2.6 Pressure transducer monitoring

In stage Ready for operation the measured value of the pressure transducer is com-
pared with fixed set values. If the signal of the pressure transducer is not within
the preset tolerance range, the message Chamber pressure off tolerance band is in-
dicated and the unit cannot be started.

In cycle stage sterilization, the measured values of the two pressure transducers
control and recording are continuously compared with each other. If the deviation
from each other is too large, the malfunction message Difference P10/P11 during
sterilization too high will appear and the program will be interrupted.

38
 Operating Malfunctions
System Safety
6.2.7 Cycle time monitoring

The period of the cycle time is monitored in all stages of the program. If a cycle
stages inacceptably exceeds its provided time, the program will be interrupted and
the following message will appear: Cycle time exceeded

6.2.8 CAN bus monitoring

The availability of all CAN bus components is continuously monitored. These are:
D all temperature probes

D all pressure transducers

D Info bar
D Teleclock

If one of these components fails, this will be displayed immediately.

6.2.9 Motor protection switch vacuum pump

The thermoelectric protective switch monitors the operation of the vacuum pump
in all stages of the program run, during which the vacuum pump is actuated. If this
protective switch is triggered, e.g. due to too high a switch temperature or current
consumption, the power supply of the vacuum pump is interrupted. The display
shows the following message Motor protection vacuum pump

The fault is to be rectified by the technical staff or by MMM customer service.

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

39
Operating Malfunctions
System Safety
6.3 Residual Risks

6.3.1 Worker’s protection

The risk of endangering operating personnel or third parties is minimized by obser-

ving EN 61010--1 (safety regulations governing electrical measuring, controlling
and regulating devices and laboratory units) and EN 61010--2--042 (special require-
ments for autoclaves and sterilizers when using toxic gases for the treatment of me-
dical material and for laboratory applications) as well as the Technical Rules for
hazardous matters, in this case TRGS 513.

At present, formaldehyde is rated as detrimental to health but it can be assumed that

carcinogenic risk for people does not exist when respecting the threshold limit va-
lue.

With all conditions and the threshold limit value being observed and the operation
being in accordance with its design purpose the residual risk of endangering health
is generally regarded as minor and accepted.

6.3.2 Patient’s Protection

6.3.2.1 Sterilization Safety

The particular reaction kinetics of micro--organisms results in a certain purely ma-

thematically probability of an unsterile unit. With the procedures given this de-
pends only of the quantity of the bioburden and the resistance of the germs.
Further possible residual risks:
D unknown bioburden (nature and quantity) owing to non--validated cleaning pro-

cedures.
D the use of new items to be sterilized of which the sterilization procedure was not

validated always involves the risk of unsterility. (The manufacturer of the medi-
cal device to be sterilized must indicate the sterilization method.)

6.3.2.2 Residues on the sterilized goods

The manufacturer of the medical devices to be sterilized is responsible for the indi-
cation of appropriate resterilization methods.

At present scientific tests on the effect of formaldehyde residues on sterilized items

on the human organism and metabolism are not known.

40
7 Maintenance, Cleaning and Care

7.1 General

According to TRGS 513 all maintenance and servicing tasks as well as any impor-
tant modifications to gas sterilizers are to be carried out only by the manufacturer
or by persons authorized by the manufacturer.

It is particularly important to ensure that all unit components are regularly inspected
and maintained.

Make sure, that the agent receptacles are connected to the correct connections
Important provided .

7.2 Maintenance intervals

Daily

Visually inspect the sterilization chamber for signs of residual moisture and foreign
matter.

Weekly
D Clean the interior of the sterilization chamber. Cover the drains in the chamber

before you start cleaning in order to prevent foreign matter from entering into
the pipe system.
D Check the door gaskets on the interior side of the door plate for damage and clean

them with a lintfree cloth.

Every six months

D Exchange the air filter insert of the Euro--Formomat.
D Clean the dirt trap of the water feed pipe.

Once a year

Gas sterilizers and their safety devices must be inspected by an authorized expert
once a year The results of the inspection must be entered in the system log book.

Instructions for Use Euro--Formomat 010021527--71310 GB /01.04

41
Maintenance, Cleaning and Care
7.3 Interior walls

Life and safety of the pressure vessel can be substantially lengthened by regular
care. Note that the surface of the interior walls of the sterilization chamber and the
door(s) should always look metallic bright. Should these surfaces become dull or
lightly discolored or mottles after lengthy use remove such tarnish by means of a
commercially available gentle detergent solution.

Subsequent rinsing is done by wiping up the surfaces with water free from any addi-
tives.

7.4 External care

To clean the stainless--steel front panelling we recommend to use the MMM stain-
less--steel detergent spray ULTRAPUR D (refer to the annex for the article number).

7.5 Interior Space of the unit

We recommend to clean and disinfect the machine interior spaces thoroughly, as

just a few dust is sufficient to increase the amount of germs.

Every three months the interior space of the unit is to be cleaned with an industrial
vacuum cleaner fitted with a disposable (paper) dust bag. Afterwards all systems
components are to be disinfected by an approved disinfectant spray.

7.6 Servicing, Obligatory Regular Inspection

According to German TRGS 513, item 13, maintenance work, servicing as well as
essential modifications to gas sterilizers must be carried out only by the manufactu-
rer or by personnel authorized by the manufacturer. Gas sterilizers and their safety
devices must be inspected by an authorized expert at least once a year The results
of the inspection must be entered in the system log book.

We expressly point out that we do not accept any liability for any damage at the sy-
stem or for personal injuries in connection with the system, if the system was repai-
red or serviced by persons that were not authorised by MMM.

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Maintenance, Cleaning and Care
7.7 Monitoring of efficiency of the steriliza-
tion agent

Sterilization processes that work to the low--temperature steam and formaldehyde

method must be validated. The repeated performance qualification must be effected
within one year.

Further information on this topic can be found in DIN 58948 part 16 or in the direc-
tive issued by the German DGKH.

7.8 Service

We recommend to conclude an after--sales contract with our service department,

which carries out special servicing twice a year to check all system functions and
components.

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43
8 Warranty

MMM is responsible for the perfect delivery and functioning of the devices as des-
cribed in the contracts for delivery, factory delivery and assembly. Please refer to
the MMM contractual and delivery conditions.

MMM assumes no liability for defects or other damages resulting from natural
wear, chemical or physical influences, excessive strain, faulty handling or unsuita-
ble or inappropriate usage – especially through non--observance of the operating
instructions included with or attached to the device, for faulty assembly or commis-
sioning on the part of the purchaser or third parties, for damage caused by foreign
substances, when using sterilization agents that are not a product of a quality super-
vised process or for faulty or inappropriate servicing.

Faulty or inappropriate servicing includes servicing not performed at those time in-
tervals prescribed by the manufacturer, or servicing performed by persons not au-
thorised by the manufacturer. It also includes faulty or inappropriate repairs by per-
sons unauthorised by the manufacturer.

For the correct connection of MMM systems to the supply and discharge pipes pro-
vided on site, the specifications of the MMM installation drawing (including the
technical data specified in the contract) are binding for the parties to the contract.
The MMM warranty obligation is void in cases of damage to the machine resulting
from negative variations in the subsequent operational conditions of these lines
due, for example, to insufficient supply pressure or deficient quality of the supplied
contents.

Please note the relevant standards DIN 58 946, part 2, DIN 58 948, part 2 and
DIN 58 949, part 2.

The contractual stipulations define the beginning and end of the warranty period.

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 Annex

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45
46